As filed with the Securities and Exchange
Commission on January 21, 2025
Registration No. 333-283722
UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
Amendment
No. 1
to
FORM S-1
REGISTRATION STATEMENT UNDER THE SECURITIES
ACT OF 1933
Theriva Biologics, Inc.
(Exact Name of Registrant as Specified in its
Charter)
Nevada |
|
2834 |
|
26-279813 |
(State or other jurisdiction of
incorporation or organization) |
|
(Primary Standard Industrial
Classification Code Number) |
|
(I.R.S. Employer
Identification No.) |
9605 Medical Center, Suite 270
Rockville, MD 20850
(301) 417-4364
(Address, Including Zip Code, and Telephone
Number, Including Area Code, of Registrant’s Principal Executive Offices)
Steven A. Shallcross
Chief Executive Officer and
Chief Financial Officer
9605 Medical Center, Suite 270
Rockville, MD 20850
(301) 417-4364
(Name, Address, Including Zip Code, and Telephone
Number, Including Area Code, of Agent for Service)
Copies to:
Leslie Marlow, Esq.
Patrick J. Egan, Esq.
Melissa Palat Murawsky, Esq.
Hank Gracin, Esq.
Blank Rome LLP
1271 Avenue of the Americas
New York, New York 10020
Phone: (212) 885-5000 |
Faith L. Charles, Esq.
Thompson Hine LLP
300 Madison Avenue, 27th Floor
New York, New York 10017
(212) 344-5680 |
Approximate date of commencement of proposed
sale to the public: From time to time after the date this registration statement becomes effective.
If any of the securities being registered on this
Form are to be offered on a delayed or continuous basis pursuant to Rule 415 under the Securities Act of 1933, check the following
box. x
If this Form is filed to register additional
securities for an offering pursuant to Rule 462(b) under the Securities Act, please check the following box and list the Securities
Act registration statement number of the earlier effective registration statement for the same offering. ¨
If this Form is a post-effective amendment
filed pursuant to Rule 462(c) under the Securities Act, check the following box and list the Securities Act registration statement
number of the earlier effective registration statement for the same offering. ¨
If this Form is a post-effective amendment
filed pursuant to Rule 462(d) under the Securities Act, check the following box and list the Securities Act registration statement
number of the earlier effective registration statement for the same offering. ¨
Indicate by check mark whether the registrant is
a large accelerated filer, an accelerated filer, a non-accelerated filer, a smaller reporting company, or an emerging growth company.
See the definitions of “large accelerated filer,” “accelerated filer”, “smaller reporting company”
and “emerging growth company” in Rule 12b-2 of the Exchange Act.
Large accelerated filer |
¨ |
Accelerated filer |
¨ |
Non-accelerated filer |
x |
Smaller reporting company |
x |
|
|
Emerging growth company |
¨ |
If an emerging growth company, indicate by check
mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting
standards provided pursuant to Section 7(a)(2)(B) of the Securities Act. ¨
The Registrant hereby amends this Registration
Statement on such date or dates as may be necessary to delay its effective date until the Registrant shall file a further amendment which
specifically states that this Registration Statement shall thereafter become effective in accordance with Section 8(a) of the
Securities Act of 1933, as amended, or until the Registration Statement shall become effective on such date as the Commission, acting
pursuant to said Section 8(a), may determine.
The information in this prospectus
is not complete and may be changed. These securities may not be sold until the registration statement filed with the Securities and Exchange
Commission is effective. This prospectus is not an offer to sell these securities and it is not soliciting an offer to buy these securities
in any jurisdiction where the offer or sale is not permitted.
PRELIMINARY PROSPECTUS | SUBJECT
TO COMPLETION | DATED January
21, 2025 |
Up to 6,756,756 Shares of Common Stock
Up to 6,756,756 Common Warrants to Purchase Up to 6,756,756 Shares of Common Stock
Up to 6,756,756 Pre-Funded Warrants to Purchase Up to 6,756,756 Shares of Common Stock
Up to 13,513,512 Shares of Common Stock Underlying the Common Warrants and Pre-Funded Warrants
We are offering on a best efforts basis up to 6,756,756 shares
of our common stock, par value $0.001 (the “Common Stock”), together with warrants to purchase up to 6,756,756 shares
of our Common Stock. Each share of Common Stock, or a pre-funded warrant in lieu thereof, is being sold together with a common warrant
to purchase one share of Common Stock (the “Common Warrant”). The shares of Common Stock and Common Warrants are immediately
separable and will be issued separately in this offering, but must be purchased together in this offering. The assumed public offering
price for each share of Common Stock and accompanying Common Warrant is $1.48, which was the closing price of our Common Stock on the
NYSE American LLC (“NYSE American”) on January 17, 2025. Each Common Warrant will have an exercise price per share of $[·]
and will be immediately exercisable. The Common Warrants will expire on the 5-year anniversary of the original issuance date.
We are also offering to certain purchasers whose purchase of shares
of Common Stock in this offering would otherwise result in the purchaser, together with its affiliates and certain related parties, beneficially
owning more than 4.99% (or, at the election of the purchaser, 9.99%) of our outstanding Common Stock immediately following the consummation
of this offering, the opportunity to purchase, if any such purchaser so chooses, pre-funded warrants (the “Pre-Funded Warrants”),
in lieu of shares of Common Stock that would otherwise result in such purchaser’s beneficial ownership exceeding 4.99% (or, at
the election of the purchaser, 9.99%) of our outstanding Common Stock. The public offering price of each Pre-Funded Warrant and accompanying
Common Warrant will be equal to the price at which one share of Common Stock and accompanying Common Warrant is sold to the public in
this offering, minus $0.001, and the exercise price of each Pre-Funded Warrant will be $0.001 per share. The Pre-Funded Warrants will
be immediately exercisable and may be exercised at any time until all of the Pre-Funded Warrants are exercised in full. The Pre-Funded
Warrants and Common Warrants are immediately separable and will be issued separately in this offering, but must be purchased together
in this offering. For each Pre-Funded Warrant we sell, the number of shares of Common Stock we are offering will be decreased on a one-for-one
basis.
We have engaged A.G.P./Alliance Global Partners (“A.G.P.”
or the “Placement Agent”), to act as our sole placement agent, to use its reasonable best efforts to arrange for the sale
of the securities offered by this prospectus. The Placement Agent is not purchasing or selling any of the securities we are offering,
and the Placement Agent is not required to arrange the purchase or sale of any specific number or dollar amount of securities.
The securities will be offered at a fixed price and are expected
to be issued in a single closing. The offering will terminate on February 12, 2025, unless (i) the closing occurs prior thereto
or (ii) we decide to terminate the offering prior thereto (which we may do at any time in our discretion). Investors purchasing
securities offered hereby will have the option to execute a securities purchase agreement with us. We expect that the closing of the
offering will occur one trading day after we price the securities offered hereby if we price such securities prior to 4:01 p.m. eastern
time on a trading day and two trading days after we price the Securities offered hereby if we price such securities at any other time.
When we price the securities, we will simultaneously enter into securities purchase agreements relating to the offering with those investors
who so choose. The offering will settle delivery versus payment (“DVP”)/receipt versus payment (“RVP”). That
is, on the closing date, we will issue the shares of Common Stock directly to the account(s) at the Placement Agent identified by
each purchaser; upon receipt of such shares, the Placement Agent shall promptly electronically deliver such shares to the applicable
purchaser, and payment therefor shall be made by the Placement Agent (or its clearing firm) by wire transfer to us.
Since we will deliver the securities to be issued in this offering
upon our receipt of investor funds, we and the Placement Agent have not made any arrangements to place investor funds in an escrow account
or trust account. Because this is a best-efforts offering, the Placement Agent does not have an obligation to purchase any securities,
and, as a result, there is a possibility that we may not be able to sell the securities. There is no minimum offering requirement as
a condition of closing of this offering. Because there is no minimum offering amount required as a condition to closing this offering,
we may sell fewer than all of the securities offered hereby, which may significantly reduce the amount of proceeds received by us, and
investors in this offering will not receive a refund in the event that we do not sell an amount of securities sufficient to pursue our
business goals described in this prospectus. In addition, because there is no escrow account and no minimum offering amount, investors
could be in a position where they have invested in our company, but we are unable to fulfill all of our contemplated objectives due to
a lack of interest in this offering. Further, any proceeds from the sale of securities offered by us will be available for our immediate
use, despite uncertainty about whether we would be able to use such funds to effectively implement our business plan. See the section
entitled “Risk Factors” for more information.
Our Common Stock is listed on the NYSE American under the symbol
“TOVX.” On January 17, 2025, the last reported sale price of our Common Stock on the NYSE American was $1.48 per
share. The actual public offering price per share of Common Stock and accompanying Common Warrant, and per Pre-Funded Warrant and accompanying
Common Warrant, will be determined between us, the Placement Agent and the investors in this offering at the time of pricing, and may
be at a discount to the current market price for the Common Stock. Therefore, the recent market price used throughout this preliminary
prospectus as an assumed offering price per share of Common Stock and accompanying Common Warrant may not be indicative of the final
offering price. There is no established public trading market for the Common Warrants and the Pre-Funded Warrants, and we do not expect
such a market to develop. Without an active trading market, the liquidity of the Common Warrants and the Pre-Funded Warrants will be
limited. In addition, we do not intend to list the Common Warrants and the Pre-Funded Warrants on NYSE American, any other national securities
exchange or any other trading system.
Investing in our securities involves risks. You should review carefully
the risks and uncertainties described under the heading “Risk Factors” contained in this prospectus and under similar
headings in the other documents that are incorporated by reference into this prospectus, as described beginning on page 9 of this
prospectus.
Neither the Securities and Exchange Commission nor any state securities
commission has approved or disapproved of the securities to be issued under this prospectus or determined if this prospectus is truthful
or complete. Any representation to the contrary is a criminal offense.
| |
Per
Share of
Common Stock
and
Accompanying
Common
Warrant | |
Per Pre-Funded Warrant and
Accompanying Common Warrant | |
Total |
Public offering price(1) | |
$ | |
$ | |
$ |
Placement agent fees(2) | |
$ | |
$ | |
$ |
Proceeds to us, before expenses(3) | |
$ | |
$ | |
$ |
| (1) | The
assumed combined public offering price is $1.48 per share of Common Stock and accompanying
Common Warrant and $1.4799 per Pre-Funded Warrant and accompanying Common Warrant. |
| (2) | Represents a cash fee equal to 7.0% of the aggregate purchase price
paid by investors in this offering. See “Plan of Distribution” for additional
disclosure regarding compensation payable to the Placement Agent. |
| (3) | Does not include proceeds from the exercise of the Common Warrants
and/or Pre-Funded Warrants in cash, if any. |
Delivery of the securities is expected to be made on or about ,
2025.
Sole Placement Agent
A.G.P.
The date of this prospectus is ,
2025
Table
of Contents
ABOUT
THIS PROSPECTUS
You should rely only on the information that we have provided or incorporated
by reference in this prospectus. We have not authorized anyone to provide you with different or additional information. If anyone provides
you with different or additional information, you should not rely on it. You should assume that the information in this prospectus is
accurate only as of the date on the cover of the document and that any information we have incorporated by reference is accurate only
as of the date of the document incorporated by reference, regardless of the time of delivery of this prospectus or any sale of a security.
Our business, financial condition, results of operations and prospects may have changed since those dates.
We urge you to carefully read this prospectus, together with the information
incorporated herein by reference as described under the heading “Where You Can Find Additional Information.”
In this prospectus, unless otherwise specified or the context requires
otherwise, we use the terms “Theriva,” “Company,” “we,” “us” and “our” or
similar references to refer to Theriva Biologics, Inc., a Nevada corporation, together with its consolidated subsidiaries.
Special
Note Regarding Forward-Looking Statements
This prospectus and the documents incorporated by reference into this
prospectus include forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended, or the
Securities Act, and Section 21E of the Securities Exchange Act of 1934, as amended, or the Exchange Act, that relate to future events
or our future financial performance and involve known and unknown risks, uncertainties and other factors that may cause our actual results,
levels of activity, performance or achievements to differ materially from any future results, levels of activity, performance or achievements
expressed or implied by these forward-looking statements. Words such as, but not limited to, “anticipate,” “aim,”
“believe,” “contemplate,” “continue,” “could,” “design,” “estimate,”
“expect,” “intend,” “may,” “might,” “plan,” “predict,” “poise,”
“project,” “potential,” “suggest,” “should,” “strategy,” “target,”
“will,” “would,” and similar expressions or phrases, or the negative of those expressions or phrases, are intended
to identify forward-looking statements, although not all forward-looking statements contain these identifying words. Although we believe
that we have a reasonable basis for each forward-looking statement contained in this prospectus and incorporated by reference into this
prospectus, we caution you that these statements are based on our projections of the future that are subject to known and unknown risks
and uncertainties and other factors that may cause our actual results, level of activity, performance or achievements expressed or implied
by these forward-looking statements, to differ. The section in this prospectus entitled “Risk Factors” and the sections in
our periodic reports, including the Annual
Report on Form 10-K for the year ended December 31, 2023 filed with the Securities and Exchange Commission( the “SEC”),
on March 25, 2024 entitled “Business,” “Risk Factors” and “Management’s Discussion and Analysis
of Financial Condition and Results of Operations,” and the Quarterly
Report on Form 10-Q for the quarter ended September 30, 2024 filed with the SEC on November 12, 2024 as well as other
sections in this prospectus and the documents or reports incorporated by reference into this prospectus, discuss some of the factors
that could contribute to these differences.
Please consider our forward-looking statements in light of those risks
as you read this prospectus and the documents incorporated by reference into this prospectus. It is not possible for our management to
predict all risks, nor can we assess the impact of all factors on our business or the extent to which any factor, or combination of factors,
may cause actual results to differ materially from those contained in any forward-looking statements we may make. Given these uncertainties,
you should not place undue reliance on these forward-looking statements.
You should not assume that the information contained in this prospectus
is accurate as of any date other than as of the date of this prospectus, or that any information incorporated by reference into this
prospectus is accurate as of any date other than the date of the document so incorporated by reference. Except as required by law, we
assume no obligation to update these forward-looking statements publicly, or to update the reasons actual results could differ materially
from those anticipated in these forward-looking statements, even if new information becomes available in the future. Thus, you should
not assume that our silence over time means that actual events are bearing out as expressed or implied in such forward-looking statements.
If one or more of these or other risks or uncertainties materializes,
or if our underlying assumptions prove to be incorrect, actual results may vary materially from what we anticipate. All subsequent written
and oral forward-looking statements attributable to us or individuals acting on our behalf are expressly qualified in their entirety
by this Note. Before purchasing any securities, you should consider carefully all of the factors set forth or referred to in this prospectus
and the documents incorporated by reference that could cause actual results to differ.
We may not actually achieve the plans, intentions or expectations
disclosed in our forward-looking statements, and you should not place undue reliance on our forward-looking statements. Forward-looking
statements should be regarded solely as our current plans, estimates and beliefs. We have included important factors in the cautionary
statements included in this document, particularly in the section entitled “Risk Factors” of this prospectus that we believe
could cause actual results or events to differ materially from the forward-looking statements that we make. Moreover, we operate in a
very competitive and rapidly changing environment. New risks emerge from time to time. It is not possible for our management to predict
all risks, nor can we assess the impact of all factors on our business or the extent to which any factor, or combination of factors,
may cause actual results to differ materially from those contained in any forward-looking statements we may make. Given these risks and
uncertainties, readers are cautioned not to place undue reliance on such forward-looking statements. All forward-looking statements are
qualified in their entirety by this cautionary statement. Our forward-looking statements do not reflect the potential impact of any future
acquisitions, mergers, dispositions, joint ventures or investments we may make. You should read this prospectus and the documents that
we have filed as exhibits to this prospectus and incorporated by reference herein completely and with the understanding that our actual
future results may be materially different from the plans, intentions and expectations disclosed in the forward-looking statements we
make. The forward-looking statements contained in this prospectus are made as of the date of this prospectus and we do not assume any
obligation to update any forward-looking statements, whether as a result of new information, future events or otherwise, except as required
by applicable law.
PROSPECTUS
SUMMARY
This summary contains basic information about us and this offering.
Because it is a summary, it does not contain all of the information that you should consider before deciding to invest in our securities.
Before you decide to invest in our securities, you should read this entire prospectus carefully and the documents incorporated by reference
herein, including the information included under the heading titled “Risk Factors.” Unless we specify otherwise, all references
in this prospectus to “Theriva,” “we,” “our,” “us” and “our company” refer
to Theriva Biologics, Inc.
Overview
We are a diversified clinical-stage company developing therapeutics
designed to treat cancer and related diseases in areas of high unmet need. As a result of the acquisition in March 2022 of Theriva
Biologics, S.L. (“VCN”, formerly named VCN Biosciences, S.L.), described in more detail below (the “Acquisition”),
we began transitioning our strategic focus to oncology, which is now our primary focus, through the development of VCN’s new oncolytic
adenovirus platform designed for intravenous and intravitreal delivery to trigger tumor cell death, to improve access of co-administered
cancer therapies to the tumor, and to promote a robust and sustained anti-tumor response by the patient’s immune system. Our lead
product candidate, VCN-01, a clinical stage oncolytic human adenovirus that is modified for tumor-selective replication and to express
an enzyme, PH20 hyaluronidase, is currently being evaluated in a Phase 2 clinical study for the treatment of pancreatic cancer (“Virage”),
and has recently been used to treat patients in a Phase 1 clinical study for the treatment of retinoblastoma, and Phase 1 clinical
studies for the treatment of other solid tumors including head and neck squamous cell carcinoma.
Prior to the Acquisition, our focus was on developing therapeutics
designed to treat gastrointestinal (GI) diseases which included our clinical development candidates: (1) SYN-004 (ribaxamase) which
is designed to degrade certain commonly used intravenous (IV) beta-lactam antibiotics within the GI tract to prevent microbiome
damage, thereby preventing overgrowth and infection by pathogenic organisms such Clostridioides difficile infection (CDI) and vancomycin
resistant Enterococci (VRE), and reducing the incidence and severity of acute graft-versus-host-disease (aGVHD) in allogeneic hematopoietic
cell transplant (HCT) recipients, and (2) SYN-020, a recombinant oral formulation of the enzyme intestinal alkaline phosphatase
(IAP) produced under cGMP conditions and intended to treat both local GI and systemic diseases. As part of our strategic transformation
into an oncology focused company, we are exploring value creation options for our SYN-004 and SYN-020 assets, including out-licensing
or partnering.
Our Current Product Pipeline
*Based on management’s current beliefs and expectations
Defined terms. allo-HCT allogeneic hematopoietic cell transplant.
CSR clinical study report. HNSCC head and neck squamous cell carcinoma. IV intravenous. IVit intravitreal.
For other abbreviations see the text.
¹Additional products with preclinical proof-of-concept include
SYN-006 (carbapenemase) to prevent aGVHD, CDI, and microbiome damage in patients treated with carbapenem antibiotics and SYN-007 (ribaxamase)
DR to prevent antibiotic associated diarrhea with oral β-lactam antibiotics.
²Depending on funding/partnership. SYN-004 may enter a U.S. Food
and Drug Administration (“FDA”)-agreed Phase 3 clinical trial for the treatment of CDI.
Recent Developments
Type D Meeting
On December 5, 2024, we issued a press release announcing the
outcomes of a recent Type D meeting with the FDA to obtain guidance on the design of a Phase 3 clinical study of lead clinical candidate
VCN-01 in combination with standard-of-care chemotherapy for the treatment of PDAC. We previously announced the completion of target
enrollment into the multinational VIRAGE Phase 2b clinical study evaluating intravenous VCN-01 in combination with gemcitabine/nab-paclitaxel
as a first line therapy for PDAC patients. Type D meetings are focused on a narrow set of issues that are used to discuss issues at key
decision points to provide timely feedback critical to moving a drug development program forward. The FDA advised that the on-going VIRAGE
Phase 2b study should not be expanded into a Phase 3 study; rather, the optimal path forward for the VCN-01 PDAC program is to conduct
a stand-alone Phase 3 study of VCN-01 with gemcitabine/nab-paclitaxel. The FDA provided general agreement with the Company’s proposed
design for a Phase 3 clinical study and indicated that inclusion of additional standard-of-care chemotherapy for PDAC was not necessary
as it would complicate the study design and analysis. The FDA meeting also highlighted the FDA’s preferences regarding certain
statistical elements of confirmatory clinical studies, including methods for sample size estimation and the study population(s) used
for data analysis.
Reverse Stock Split
On August 15, 2024, our Board of Directors approved a reverse
stock split of our authorized, issued and outstanding shares of Common Stock, at a ratio of one (1) share of Common Stock for twenty-five
(25) shares of Common Stock (the “Reverse Stock Split”). The Reverse Stock Split was effective on August 26, 2024. Any
share amounts and exercise or conversion prices in this prospectus and the registration statement of which it forms a part have been
adjusted retrospectively for the Reverse Stock Split.
September 2024 Public Offering
On September 27, 2024, we consummated a public offering (the
“September Offering”) of an aggregate of (i) 918,600 shares (the “September Shares”) of Common
Stock, (ii) pre-funded warrants (“September Pre-Funded Warrants”) to purchase up to 510,000 shares of Common Stock
(the “September Pre-Funded Warrant Shares”), and (iii) Common Stock purchase warrants (“September Common
Warrants”) to purchase up to 1,428,600 shares of Common Stock (the “September Common Warrant Shares”). Each September Share
and associated September Common Warrant to purchase one (1) September Common Warrant Share was sold at a combined public
offering price of $1.75. Each September Pre-Funded Warrant and associated September Common Warrant to purchase one (1) September Common
Warrant Share was sold at a combined public offering price of $1.7499. We received aggregate gross proceeds from the September Offering
of approximately $2.5 million, before deducting placement agent fees and other offering expenses. Each September Common Warrant
has an exercise price of $2.00 per share, is immediately exercisable for one (1) September Common Warrant Share, and expires
five (5) years from its issuance date. The September Common Warrants may be exercised on a cashless basis if at the time of
exercise thereof there is no effective registration statement registering, or the prospectus contained therein is not available for,
the issuance of the September Common Warrant Shares to the holder. As of October 3, 2024, all of the September Pre-Funded
Warrants were exercised.
Preferred Shares Conversion
On July 30, 2024, we received a notice of conversion from the
holder of shares of our Series C Convertible Preferred Stock to convert 135,431 shares of Series C Convertible Preferred Stock
into 35,523 shares of Common Stock at a conversion price of $30.50 per share of Common Stock.
On September 6, 2024, we received a notice of conversion from
the holder of 4,138 shares of our Series C Convertible Preferred Stock and 100,000 shares of our Series D Convertible Preferred
Stock to convert the 4,138 shares of Series C Convertible Preferred Stock into 1,086 shares of our Common Stock at a conversion
price of $30.50 per share and to convert the 100,000 shares of Series D Convertible Preferred Stock into 26,230 shares of Common
Stock at a conversion price of $30.50 per share of Common Stock. On September 6, 2024, we issued an aggregate of 27,316 shares of
Common Stock upon conversion of such shares of Series C Convertible Preferred Stock and Series D Convertible Preferred Stock.
Upon such conversion there are no shares of Series C Convertible Preferred Stock or Series D Convertible Preferred Stock outstanding.
Other Financial Developments
On September 16, 2024, we announced that the THERICEL project
has been awarded funding of €2.28 million ($2.54 million) from the National Knowledge Transfer Program of the Spanish government’s
Ministry of Science, Innovation & Universities to support a collaboration between us and the Universitat Autònoma
de Barcelona (“UAB”) to advance our suspension cell platform for the clinical manufacture of adenovirus- and adeno-associated
virus (“AAV”) therapies. Under the award, we will receive an unsecured loan of €1.33 million ($1.48 million) as a lump
sum payment in the fourth quarter of 2024 which shall bear interest at a rate of 4.015% and be repaid over 7 years commencing three years
from the date of award, and UAB will receive a grant of €0.95 million ($1.06 million) dedicated to the THERICEL project and paid
in annual installments over the next 3 years.
2024 Annual Stockholder’s Meeting
On October 31, 2024, we held our 2024 Annual Meeting of Stockholders
(the “Annual Meeting”). At the Annual Meeting, our stockholders (i) elected Jeffrey J. Kraws, John Monahan, Steven A.
Shallcross and Jeffery Wolf as directors; (ii) ratified the appointment of BDO USA P.C. as our independent registered public accounting
firm for the year ending December 31, 2024; (iii) approved an amendment to our 2020 Stock Incentive Plan (the “2020 Stock
Incentive Plan”) to (a) increase the number of shares of Common Stock that we will have authority to grant under the 2020
Stock Incentive Plan from 280,000 shares of Common Stock to 2,500,000 shares of Common Stock and (b) to amend the annual non-employee
director grant limit to 250,000 shares of Common Stock; and (iv) approved an amendment to our Articles of Incorporation to increase
the number of authorized shares of Common Stock to 350,000,000 shares.
On November 1, 2024, we filed a Certificate of Change to our
Articles of Incorporation with the Secretary of State of the State of Nevada that was effective on such date that increased the number
of our authorized shares of Common Stock, from 14,000,000 shares to 350,000,000 shares.
Corporate Information
Our predecessor, Sheffield Pharmaceuticals, Inc., was incorporated
in 1986, and in 2006 engaged in a reverse merger with Pipex Therapeutics, Inc., a publicly-traded Delaware corporation formed in
2001. After the reverse merger, we changed our name to Pipex Pharmaceuticals, Inc., and in October 2008 we changed our name
to Adeona Pharmaceuticals, Inc. On October 15, 2009, we engaged in a merger with a wholly owned subsidiary for the purpose
of reincorporating in the State of Nevada. On February 15, 2012, we changed our name to Synthetic Biologics, Inc. On August 10,
2018, we effected a one for thirty-five reverse stock split of our authorized, issued and outstanding Common Stock. On July 15,
2022, we effected a one for ten reverse stock split of our authorized, issued and outstanding Common Stock. On October 12, 2022,
we changed our name to Theriva Biologics, Inc. On August 26, 2024, we effected a one for twenty-five reverse stock split of
our authorized, issued and outstanding Common Stock.
Our principal executive offices are located at 9605 Medical Center
Drive, Suite 270, Rockville, Maryland 20850, and our telephone number is (301) 417-4367. Our website address is www.therivabio.com.
Information contained on our website is intended for informational purposes only and is not incorporated by reference into this prospectus,
and it should not be considered to be part of this prospectus or the registration statement of which this
prospectus forms a part. The SEC maintains an internet site that contains reports, proxy and information statements, and other information
regarding issuers like us that file documents electronically with the SEC. The address of the SEC website is www.sec.gov.
Smaller Reporting Company
We are a “smaller reporting company” as defined in the
Securities Exchange Act of 1934, as amended (the “Exchange Act”). As a result, we may take advantage of certain reduced disclosure
obligations available to smaller reporting companies, including the exemption from compliance with the auditor attestation requirements
pursuant to the Sarbanes-Oxley Act of 2022, reduced disclosure about our executive compensation arrangements and the requirements to
provide only two years of audited financial statements in our annual reports and registration statements. We will continue to be a “smaller
reporting company” as long as (1) we have a public float (i.e., the market value of our common stock held by non-affiliates)
less than $250 million calculated as of the last business day of our most recently completed second fiscal quarter, or (2) our annual
revenues are less than $100 million for our previous fiscal year and we have either no public float or a public float of less than $700
million as of the end of that fiscal year’s second fiscal quarter. Decreased disclosures in our SEC filings due to our status as
a “smaller reporting company” may make it harder for investors to analyze our results of operations and financial prospects.
THE
OFFERING
Securities
offered by us: |
|
Up to 6,756,756 shares of Common
Stock and accompanying Common Warrants to purchase up to 6,756,756 shares of Common Stock, or up to 6,756,756 Pre-Funded Warrants
to purchase shares of Common Stock and accompanying Common Warrants to purchase up to 6,756,756 shares of Common Stock on a reasonable
“best efforts” basis. The shares of Common Stock or the Pre-Funded Warrants, and accompanying Common Warrants are immediately
separable and will be issued separately in this offering, but must initially be purchased together in this offering. The Common Warrants
are exercisable immediately, have an exercise price equal to $[·],
and will expire five years after the date of issuance. This prospectus also relates to the offering of the shares of Common Stock issuable
upon exercise of the Common Warrants and Pre-Funded Warrants. For more information regarding the Common Warrants and Pre-Funded Warrants,
you should carefully read the section titled “Description of Securities to be Registered” in this prospectus. |
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Pre-funded warrants offered by us in this offering |
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We are also offering to each purchaser whose purchase of shares of Common Stock in this offering would otherwise result in the purchaser, together with its affiliates and certain related parties, beneficially owning more than 4.99% (or, at the election of the purchaser, 9.99%) of our outstanding Common Stock immediately following the consummation of this offering, the opportunity to purchase, if the purchaser so chooses, Pre-Funded Warrants (each Pre-Funded Warrant to purchase one share of our Common Stock) in lieu of shares that would otherwise result in the purchaser’s beneficial ownership exceeding 4.99% of our outstanding Common Stock (or, at the election of the purchaser, 9.99%). The purchase price of each Pre-Funded Warrant and accompanying Common Warrant will equal the price at which one share of Common Stock and accompanying Common Warrant are being sold to the public in this offering, minus $0.001, and the exercise price of each Pre-Funded Warrant will be $0.001 per share. The Pre-Funded Warrants will be exercisable immediately and may be exercised at any time until all of the Pre-Funded Warrants are exercised in full. For each Pre-Funded Warrant we sell, the number of shares of Common Stock we are offering will be decreased on a one-for-one basis. |
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Reasonable Best Efforts Offering |
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We have agreed to issue and sell the securities offered hereby to the purchasers through the Placement Agent. The Placement Agent is not required to buy or sell any specific number or dollar amount of the securities offered hereby, but will use its reasonable best efforts to solicit offers to purchase the securities offered by this prospectus. See “Plan of Distribution” beginning on page 42 of this prospectus. |
Use of
proceeds |
|
Assuming all of the securities we are offering under this prospectus
are sold at an assumed public offering price of $1.48 per share of Common Stock and accompanying Common Warrant and assuming
no sale of any Pre-Funded Warrants, we estimate that we will receive approximately $8.95 million in net proceeds from this offering,
after deducting the estimated placement agent fees and estimated offering expenses. However, this is a reasonable best efforts offering
with no minimum number of securities or amount of proceeds as a condition to closing, and we may not sell all or any of the securities
offered pursuant to this prospectus; as a result, we may receive significantly less in net proceeds.
We currently intend to use the net proceeds from this offering primarily
for working capital and general corporate purposes, including for research and development and manufacturing scale-up. We may also use
a portion of the net proceeds to invest in or acquire other products, businesses or technologies, although we have no commitments or agreements
with respect to any such investments or acquisitions as of the date of this prospectus. See “Use of Proceeds” for additional
information. |
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Lock-Up |
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Our directors and officers have agreed with the Placement Agent, subject
to certain exceptions, not to sell, transfer or dispose of, directly or indirectly, any of the Common Stock or securities convertible
into or exercisable or exchangeable for the Common Stock for a period of 90 days after the completion of this offering.
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Standstill |
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We have agreed, subject to certain exceptions, not to issue,
enter into any agreement to issue or announce the issuance or proposed issuance of, any shares of Common Stock (or securities convertible
into or exercisable for Common Stock) or, subject to certain exceptions, file any registration statement, including any amendments
or supplements thereto (other than the registration statement or amendment to the registration statement relating to the securities
offered hereunder and a registration statement on Form S-8), until 60 days after the completion of this offering. We have also agreed
not to enter into or issuance any shares pursuant to a variable rate transaction (as defined in the securities purchase agreement)
for six months after the completion of this offering, except that after the forty-five (45) day anniversary of the closing of this
offering we may offer shares of Common Stock pursuant to the Amended and Restated At Market Issuance Sales Agreement dated February
9, 2021, between the Company and the Placement Agent, as amended by Amendment No. 1 thereto, dated May 3, 2021, and Amendment No.
2 thereto, dated May 2, 2024 (as amended, the “ATM Sales Agreement”), provided that after the fifteen (15) day anniversary of the closing
of this offering we may file a prospectus supplement with respect to sales under the Sales Agreement.
See “Plan of Distribution” for more information. |
Risk Factors |
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You should carefully read and consider the information set forth under “Risk Factors,” together with all of the other information set forth in this prospectus, before deciding to invest in shares of the Common Stock. |
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NYSE American symbol |
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Our Common Stock is listed on the NYSE American under the symbol “TOVX.” |
Except as otherwise indicated, the number of shares of Common Stock
to be outstanding immediately after this offering is based on 2,782,449 shares of our Common Stock outstanding as of January 17,
2025 and excludes the shares of Common Stock to be issued upon exercise of the Common Warrants and Pre-Funded Warrants offered in this
offering and :
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· |
175,034 shares of Common Stock issuable upon the
exercise of outstanding stock options with a weighted average exercise price of $36.88 per share; |
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· |
1,428,600 shares of Common Stock issuable upon the
exercise of outstanding warrants to purchase Common Stock with a weighted average exercise price of $2.00 per share; and |
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2,332,636 additional shares of the Common Stock reserved for future issuance under our equity incentive plans. |
RISK
FACTORS
Our business, results of operations and financial condition and
the industry in which we operate are subject to various risks. Accordingly, investing in our securities involves a high degree of risk.
This prospectus does not describe all of those risks. You should consider the risk factors described in this prospectus below, as well
as those described under the caption “Risk Factors” in the documents incorporated by reference herein, including our Annual
Report on Form 10-K for the fiscal year ended December 31, 2023 and our Quarterly Reports on Form 10-Q for the fiscal
quarters ended March 31,
2024, June 30,
2024 and September 30,
2024, together with the other information contained or incorporated by reference in this prospectus.
We have described below and in the documents incorporated by reference
herein the most significant risk factors applicable to us, but they do not constitute all of the risks that may be applicable to us.
New risks may emerge from time to time, and it is not possible for us to predict all potential risks or to assess the likely impact of
all risks. Before making an investment decision, you should carefully consider these risks as well as other information we include or
incorporate by reference in this prospectus. This prospectus also contains forward-looking statements that involve risks and uncertainties.
Our actual results could differ materially from those anticipated in the forward-looking statements as a result of a number of factors,
including the risks described below. See the section titled “Special Note Regarding Forward-Looking Statements.”
Risks Related to Our Business
There is uncertainty regarding our ability to maintain liquidity
sufficient to operate our business effectively, which raises substantial doubt about our ability to continue as a going concern.
Our consolidated unaudited financial statements as of September 30,
2024 have been prepared under the assumption that we will continue as a going concern for the next twelve months. Our management concluded
that our recurring losses from operations and the fact that as of September 30, 2024 we have an accumulated deficit of approximately
$330.5 and working capital of $12.2 million raise substantial doubt about our ability to continue as a going concern for the next twelve
months after issuance of our financial statements. As of September 30, 2024, we had a cash and cash equivalents and restricted cash
balance of approximately $16.5 million. At December 31, 2023, we had an accumulated deficit of $309.3 million and working capital
of $20.7 million. As of December 31, 2023, we had a cash and cash equivalents and restricted cash balance of approximately $23.3
million consisting of cash and investments in highly liquid U.S. money market funds. We expect to continue to incur losses from expenses
related to the development of our product candidates and related administrative activities for the foreseeable future. We expect that
our current cash will be able to fund operations into the third quarter of 2025 but will not be sufficient to fund operations for twelve
months from the date of the filing of our Quarterly Report on Form 10-Q for the quarter ended September 30, 2024, and we will
need to seek additional capital to fulfill our operating and capital requirement for the next 12 months to advance our clinical development
program to later stages of development and commercialize our clinical product candidate. Our ability to continue as a going concern is
dependent upon our ability to obtain additional equity or debt financing, attain further operating efficiencies, reduce expenditures,
and, ultimately, to generate revenue. Although management has been successful in raising capital in the past, there can be no assurance
that we will be successful or that any needed financing will be available in the future at terms acceptable to us. Although we expect
that the proceeds form this offering will be sufficient when added to our current cash to fulfill our operating and capital requirement
for the next 12 months, this is a best efforts offering and there can be no assurance as to the amount of proceeds that we will receive
from this offering. As such, we cannot conclude that such plans will be effectively implemented within one year after the date that the
financial statements included in our Quarterly Report on Form 10-Q for the quarter ended September 30, 2024 were filed with
the SEC and there is uncertainty regarding our ability to maintain liquidity sufficient to operate our business effectively, which raises
substantial doubt about our ability to continue as a going concern. Even if we raise the maximum amount offered in this offering, we
will still require additional funds to advance our clinical development program to later stages of development and commercialize our
clinical product candidate
We will need to raise additional capital to operate our business
and our failure to obtain funding when needed may force us to delay, reduce or eliminate certain of our development programs or commercialization
efforts.
During the nine months ended September 30, 2024, our operating
activities used net cash of approximately $12.2 million and our cash and cash equivalents were approximately $16.4 million as of September 30,
2024. With the exception of the three months ended June 30, 2010 and the three months ended December 31, 2017, we have experienced
significant losses since inception and have a significant accumulated deficit. As of September 30, 2024, our accumulated deficit
totaled approximately $330.5 million on a consolidated basis. Pursuant to the VCN Purchase Agreement, we have agreed to use reasonable
efforts to commercialize VCN-01 and we agreed as a post- closing covenant to commit to fund VCN’s research and development programs,
including but not limited to VCN-01 PDAC phase 2 clinical trial, VCN-01 RB trial and necessary G&A within a budgetary plan of approximately
$27.8 million over three years. We expect to incur additional operating losses in the future and therefore expect our cumulative losses
to increase. With the exception of the quarter ended June 30, 2010, and limited laboratory revenues from Adeona Clinical Laboratory,
which we sold in March 2012, we have generated very minimal revenues. We do not expect to derive revenue from any source in the
near future until we or our potential partners successfully commercialize our products. We expect our expenses to increase in connection
with our anticipated activities, particularly as we continue research and development, initiate and conduct clinical trials, and seek
marketing approval for our product candidates. Until such time as we receive approval from the FDA and other regulatory authorities for
our product candidates, we will not be permitted to sell our products and therefore will not have product revenues from the sale of products.
For the foreseeable future we will have to fund all of our operations and capital expenditures from equity and debt offerings, cash on
hand, licensing and collaboration fees and grants, if any.
We will need to raise additional capital, even if we raise the maximum
amount offered in this offering, to fund our operations and meet our current timelines and we cannot be certain that funding will be
available on acceptable terms on a timely basis, or at all. Based on our current plans, our cash and cash equivalents will be sufficient
to complete our planned clinical trials of VCN-01 (in PDAC and retinoblastoma), but may not be sufficient for additional trials of VCN-01,
SYN-020 or SYN-004, or to complete the last cohort of the Phase 1a/2a clinical trial of SYN-004, which are expected to require significant
cash expenditures. In addition, based on the significant anticipated cost of a Phase 3 clinical program in a broad indication for SYN-004,
we expect it will not be feasible for us to initiate and complete this trial at this time without a partner given the capital constraints
tied to our current market cap and share price. We intend to focus our capital on our VCN-01 clinical trials and do not intend to provide
further funding for our development of VCN-004 internally but intend to our license or partner further development ofSYN-004. Further
development of VCN’s product candidates will require additional funding beyond that raised in this offering. To the extent that
we raise additional funds by issuing equity securities, our stockholders may experience significant dilution. Any debt financing, if
available, may involve restrictive covenants that may impact our ability to conduct our business and also have a dilutive effect on our
stockholders. A failure otherwise to secure additional funds when needed in the future whether through an equity or debt financing or
a sufficient amount of capital without a strategic partnership could result in us being unable to complete planned preclinical and clinical
trials or obtain approval of our product candidates from the FDA and other regulatory authorities. In addition, we could be forced to
delay, discontinue or curtail product development, forego sales and marketing efforts, and forego licensing in attractive business opportunities.
Our ability to raise capital through the sale of securities may be limited by the rules of the SEC and NYSE American that place
limits on the number and dollar amount of securities that may be sold. There can be no assurances that we will be able to raise the funds
needed, especially in light of the fact that our ability to sell securities registered on our registration statement on Form S-3
will be limited until such time the market value of our voting securities held by non-affiliates is $75 million or more. We also may
be required to seek collaborators for our product candidates at an earlier stage than otherwise would be desirable and on terms that
are less favorable than might otherwise be available.
We have identified material weaknesses in our internal controls,
and we cannot provide assurances that these weaknesses will be effectively remediated or that additional material weaknesses will not
occur in the future
If our internal control over financial reporting or our disclosure
controls and procedures are not effective, we may not be able to accurately report our financial results, prevent fraud, or file our
periodic reports in a timely manner, which may cause investors to lose confidence in our reported financial information and may lead
to a decline in our stock price. Our management is responsible for establishing and maintaining adequate internal control over our financial
reporting, as defined in Rule 13a- 15(f) under the Exchange Act. Based on our assessment, we have concluded that as of September 30,
2024 we did not maintain effective review controls at a sufficient level of precision with certain financial statement areas and over
unusual transactions involving complex accounting and related. disclosure requirements. We also did not maintain effective information
technology general controls over user access, program change management, and segregation of duties, within certain key information systems
supporting our accounting and financial reporting processes. Additionally, many of our business process controls dependent upon the information
derived from these information systems were also ineffective, as we did not design and implement controls to validate the completeness
and accuracy of underlying data utilized in the operation of those controls. While we plan to take remedial action to address the material
weaknesses, we cannot provide any assurance that such remedial measures, or any other remedial measures we take, will be effective. If
we fail to maintain effective internal control over financial reporting, we may not be able to accurately report our financial results,
detect or prevent fraud, or file our periodic reports in a timely manner, which may, among other adverse consequences, cause investors
to lose confidence in our reported financial information and lead to a decline in our stock price. In addition, a material weakness will
not be considered remediated until the applicable controls operate for a sufficient period of time and management has concluded, through
testing, that these controls are designed and operating effectively. Although management believes that the material weaknesses will be
remediated by the end of the fiscal year there can be no assurance that the deficiencies will be remediated at such time or that the
internal control over financial reporting, as modified, will enable us to identify or avoid material weaknesses in the future.
Risks Related to this Offering
We have broad discretion in the use of the net proceeds from
this offering and may not use them effectively.
We will have broad discretion in the application of the net proceeds
from this offering and could spend the proceeds in ways that do not improve our results of operations or enhance the value of the Common
Stock. Our failure to apply these funds effectively could result in financial losses that could have a material adverse effect on our
business, cause the price of our shares of Common Stock to decline and delay the development of our product candidates. Pending their
use, we may invest the net proceeds from this offering in a manner that does not produce income or that loses value.
This is a reasonable best efforts offering, with no minimum
amount of securities required to be sold, and we may sell fewer than all of the securities offered hereby.
The Placement Agent has agreed to use its reasonable best efforts
to solicit offers to purchase the securities in this offering. The Placement Agent has no obligation to buy any of the securities from
us or to arrange for the purchase or sale of any specific number or dollar amount of the securities. There is no required minimum number
of securities that must be sold as a condition to completion of this offering, and there can be no assurance that the offering contemplated
hereby will ultimately be consummated. Even if we sell securities offered hereby, because there is no minimum offering amount required
as a condition to closing of this offering, the actual offering amount is not presently determinable and may be substantially less than
the maximum amount set forth on the cover page of this prospectus. We may sell fewer than all of the securities offered hereby,
which may significantly reduce the amount of proceeds received by us. Thus, we may not raise the amount of capital we believe is required
for our operations in the short-term and may need to raise additional funds, which may not be available or available on terms acceptable
to us.
Because there is no minimum required for the
offering to close, investors in this offering will not receive a refund in the event that we do not sell an amount of securities sufficient
to pursue the business goals outlined in this prospectus.
We have not specified a minimum offering amount nor have or will we
establish an escrow account in connection with this offering. Because there is no escrow account and no minimum offering amount, investors
could be in a position where they have invested in our company, but we are unable to fulfill our objectives due to a lack of interest
in this offering. Further, because there is no escrow account in operation and no minimum investment amount, any proceeds from the sale
of securities offered by us will be available for our immediate use, despite uncertainty about whether we would be able to use such funds
to effectively implement our business plan. Investor funds will not be returned under any circumstances whether during or after the offering.
If the price of the Common Stock fluctuates significantly, your
investment could lose value.
Although the Common Stock is listed on the NYSE American, we cannot
assure you that an active public market will continue for the Common Stock. If an active public market for the Common Stock does not
continue, the trading price and liquidity of the Common Stock will be materially and adversely affected. If there is a thin trading market
or “float” for our stock, the market price for the Common Stock may fluctuate significantly more than the stock market as
a whole. Without a large float, the Common Stock would be less liquid than the stock of companies with broader public ownership and,
as a result, the trading prices of the Common Stock may be more volatile. In addition, in the absence of an active public trading market,
investors may be unable to liquidate their investment in us. Furthermore, the stock market is subject to significant price and volume
fluctuations, and the price of the Common Stock could fluctuate widely in response to several factors, including:
| · | our
quarterly or annual operating results; |
| · | investment
recommendations by securities analysts following our business or our industry; |
| · | additions
or departures of key personnel; |
| · | our
failure to achieve operating results consistent with securities analysts’ projections; |
| · | results
of our clinical trials; and |
| · | changes
in industry, general market or economic conditions. |
The stock market has experienced extreme price and volume fluctuations
in recent years that have significantly affected the quoted prices of the securities of many companies, including companies in our industry.
The changes often appear to occur without regard to specific operating performance. The price of the Common Stock could fluctuate based
upon factors that have little or nothing to do with our company and these fluctuations could materially reduce our stock price.
We do not intend to pay dividends on the Common Stock, so any
returns will be limited to increases, if any, in the Common Stock’s value. Your ability to achieve a return on your investment
will depend on appreciation, if any, in the price of the Common Stock.
We currently anticipate that we will retain future earnings for the
development, operation and expansion of our business and do not anticipate declaring or paying any cash dividends for the foreseeable
future. Any future determination to declare dividends will be made at the discretion of our board of directors and will depend on, among
other factors, our financial condition, operating results, capital requirements, general business conditions and other factors that our
board of directors may deem relevant. Any return to stockholders will therefore be limited to the appreciation in the value of their
stock, if any.
There is no public market for the Common Warrants or Pre-Funded
Warrants to purchase shares of the Common Stock being offered by us in this offering.
There is no established public trading market for the Common Warrants
or Pre-Funded Warrants to purchase shares of the Common Stock that are being offered as part of this offering, and we do not expect a
market to develop. In addition, we do not intend to apply to list the Common Warrants or Pre-Funded Warrants on any national securities
exchange or other nationally recognized trading system, including the NYSE American. Without an active market, the liquidity of the Common
Warrants and Pre-Funded Warrants will be limited.
The Common Warrants and Pre-Funded Warrants are speculative
in nature.
Except as specified therein, the Common Warrants and Pre-Funded Warrants
offered hereby do not confer any rights of Common Stock ownership on their holders, such as voting rights, but rather merely represent
the right to acquire shares of the Common Stock at a fixed price. Specifically, commencing on the date of issuance, holders of the Common
Warrants and Pre-Funded Warrants may exercise their right to acquire the shares of the Common Stock upon the payment of an exercise price
of $[·] per share in the case of Common Warrants and an exercise
price of $0.001 per share in the case of Pre-Funded Warrants. Moreover, following this offering, the market value of the Common Warrants
and Pre-Funded Warrants is uncertain and there can be no assurance that the market value of the Common Warrants will equal or exceed
their imputed public offering prices. Furthermore, each Common Warrant will expire five years from the original issuance date and each
Pre-Funded Warrant will not expire until it has been exercised in full. In the event the price of the Common Stock does not exceed the
exercise price of the Common Warrants during the period when such Common Warrants are exercisable, the Common Warrants may not have any
value. There is no established public trading market for the Common Warrants and Pre-Funded Warrants being offered in this offering,
and we do not expect a market to develop. In addition, we do not intend to apply to list the Common Warrants or Pre-Funded Warrants on
any securities exchange or nationally recognized trading system, including NYSE American. Without an active market, the liquidity of
the Common Warrants and Pre-Funded Warrants will be limited.
Except as specified therein, holders of the Common Warrants
and Pre-Funded Warrants will have no rights as a common stockholder until they acquire shares of the Common Stock.
Except as specified therein, the Common Warrants and Pre-Funded Warrants
in this offering do not confer any rights of share ownership on their holders, but rather merely represent the right to acquire shares
of the Common Stock at a fixed price. Until holders of the Common Warrants and Pre-Funded Warrants acquire shares of the Common Stock
upon exercise of the Common Warrants and Pre-Funded Warrants, as applicable, holders of Common Warrants and Pre-Funded Warrants will
have no rights with respect to our shares of Common Stock underlying such Common Warrants and Pre-Funded Warrants.
Provisions of the Common Warrants and Pre-Funded Warrants offered
by this prospectus could discourage an acquisition of us by a third party.
In addition to the provisions of our articles of incorporation, as
amended and our second amended and restated bylaws, certain provisions of the Common Warrants and Pre-Funded Warrants offered by this
prospectus could make it more difficult or expensive for a third party to acquire us. The Common Warrants and Pre-Funded Warrants prohibit
us from engaging in certain transactions constituting “fundamental transactions” unless, among other things, the surviving
entity assumes our obligations under the Common Warrants or Pre-Funded Warrants, as applicable. These and other provisions of the Common
Warrants and Pre-Funded Warrants offered by this prospectus could prevent or deter a third party from acquiring us even where the acquisition
could be beneficial to you.
We may not receive any additional funds upon the exercise of
the Common Warrants or Pre-Funded Warrants.
Each Common Warrant and each Pre-Funded Warrant may be exercised by
way of a cashless exercise under certain circumstances, meaning that the holder may not pay a cash purchase price upon exercise, but
instead would receive upon such exercise the net number of shares of Common Stock determined according to the formula set forth in the
Common Warrant or Pre-Funded Warrant, respectively. Accordingly, we may not receive any additional funds upon the exercise of the Common
Warrants or Pre-Funded Warrants.
If we sell Common Stock or preferred stock in the future, stockholders
may experience immediate dilution and, as a result, our stock price may decline.
We may from time-to-time issue additional shares of Common Stock or
preferred stock at a discount from the current trading price of the Common Stock. As a result, our stockholders could experience immediate
dilution upon the purchase of any shares sold at such discount. In addition, as opportunities present themselves, we may enter into financing
or similar arrangements in the future, including the issuance of debt securities, Common Stock or preferred stock. If we issue Common
Stock or securities convertible into Common Stock, the holders of the Common Stock could experience additional dilution and, as a result,
our stock price may decline. In addition, to the extent that any Common Warrants, Pre-Funded Warrants or options are exercised, new options
or restricted stock units are issued under our equity incentive plans, or we otherwise issue additional shares of Common Stock in the
future, at a price less than the public offering price, our stockholders could experience dilution.
Purchasers who purchase our securities in this offering pursuant
to a securities purchase agreement may have rights not available to purchasers that purchase without the benefit of a securities purchase
agreement.
In addition to rights and remedies available to all purchasers in
this offering under federal securities and state law, the purchasers that enter into a securities purchase agreement will also be able
to bring claims of breach of contract against us. The ability to pursue a claim for breach of contract provides those investors with
the means to enforce the covenants uniquely available to them under the securities purchase agreement including, but not limited to:
(i) timely delivery of securities; (ii) agreement to not enter into any financings for 60 days from closing; and (iii) indemnification
for breach of contract.
USE
OF PROCEEDS
We estimate that we will receive net proceeds from this offering
of approximately $8.95 million (assuming the sale of the maximum number of securities offered hereby), based upon an assumed public
offering price of $1.48 per share of Common Stock and accompanying Common Warrant (which is the last reported sale price of the
Common Stock on the NYSE American on January 17, 2025), after deducting the estimated Placement Agent fees and estimated offering
expenses payable by us and assuming no sale of any Pre-Funded Warrants and no exercise of the Common Warrants. However, because this
is a reasonable best efforts offering with no minimum number of securities or amount of proceeds as a condition to closing, the actual
offering amount, Placement Agent fees, and net proceeds to us are not presently determinable and may be substantially less than the maximum
amounts set forth on the cover page of this prospectus, and we may not sell all or any of the securities we are offering. As a result,
we may receive significantly less in net proceeds. We estimate that our net proceeds from the sale of 75%, 50%, and 25% of the maximum
number of securities offered in this offering would be approximately $6.625 million, $4.3 million, and $1.975 million,
respectively, after deducting the estimated Placement Agent fees and estimated offering expenses payable by us, and assuming no sale
of any Pre-Funded Warrants and assuming no exercise of the Common Warrants. We will only receive additional proceeds from the exercise
of the Common Warrants we are selling in this offering if the Common Warrants are exercised for cash. We cannot predict when or if these
Common Warrants will be exercised. It is possible that these Common Warrant may expire and may never be exercised.
Each $0.10 increase (decrease) in the assumed public offering price
of $1.48 per share of Common Stock and accompanying Common Warrant (which is the last reported sale price of the Common Stock on
the NYSE American on January 17, 2025) would increase (decrease) the net proceeds to us from this offering by approximately $628,000,
assuming the number of securities offered, as set forth on the cover page of this prospectus, remains the same, and after deducting
estimated offering expenses payable by us and assuming no sale of any Pre-Funded Warrants and assuming no exercise of the Common Warrants.
Each 100,000 share increase (decrease) in the number of securities offered by us in this offering would increase (decrease) the net proceeds
to us from this offering by approximately $138,000, assuming that the price per share of Common Stock and accompanying Common Warrant
for the offering remains at $1.48 (which is the last reported sale price of the Common Stock on the NYSE American on January 17,
2025), and after deducting the estimated offering expenses payable by us and assuming no sale of any Pre-Funded Warrants and assuming
no exercise of the Common Warrants included in the securities in the offering. Each 500,000 share increase (decrease) in the number of
securities offered by us in this offering would increase (decrease) the net proceeds to us from this offering by approximately $688,000,
assuming that the price per share of Common Stock and accompanying Common Warrant for the offering remains at $1.48 (which is the last
reported sale price of the Common Stock on the NYSE American on January 17, 2025), and after deducting the estimated offering expenses
payable by us and assuming no exercise of the Common Warrants included in the securities in the offering.
We currently intend to use the net proceeds from this offering primarily
for working capital and general corporate purposes, including for research and development and manufacturing scale-up. We may also use
a portion of the net proceeds to invest in or acquire other products, businesses or technologies, although we have no commitments or
agreements with respect to any such investments or acquisitions as of the date of this prospectus.
These estimates exclude the proceeds, if any, from the exercise
of Common Warrants offered hereby. If all of the Common Warrants offered hereby were to be exercised in cash at the assumed exercise
price of $[·] per share, we would receive additional proceeds of approximately $[·]
million. We cannot predict when or if these Common Warrants will be exercised. It is possible that these Common Warrants may expire and
may never be exercised. Additionally, these Common Warrants contain a cashless exercise provision that permit exercise of such Common
Warrants on a cashless basis at any time when there is no effective registration statement under the Securities Act covering the issuance
of the underlying shares.
The amounts and timing of any expenditures will vary depending on
the amount of cash generated by our operations, and the rate of growth, if any, of our business, and our plans and business conditions.
The foregoing represents our intentions as of the date of this prospectus based upon our current plans and business conditions to use
and allocate the net proceeds of the offering. However, our management will have significant flexibility and discretion in the timing
and application of the net proceeds of the offering. Unforeseen events or changed business conditions may result in application of the
proceeds of the offering in a manner other than as described in this prospectus.
To the extent that the net proceeds we receive from the offering are
not immediately applied for the above purposes, we plan to invest the net proceeds in short-term, investment-grade, interest-bearing
instruments and U.S. government securities.
Dividend
Policy
We have never declared or paid any cash dividends on the Common Stock
and we do not currently intend to pay any cash dividends on the Common Stock in the foreseeable future. We expect to retain all available
funds and future earnings, if any, to fund the development and growth of our business. Any future determination to pay dividends, if
any, on the Common Stock will be at the discretion of our board of directors and will depend on, among other factors, the terms of any
outstanding preferred stock, our results of operations, financial condition, capital requirements and contractual restrictions.
Executive
Compensation
We are a “smaller reporting company”
and the following compensation disclosure is intended to comply with the requirements applicable to smaller reporting companies. Although
the rules allow us to provide less detail about our executive compensation program, the Compensation Committee is committed to providing
the information necessary to help stockholders understand its executive compensation-related decisions. Accordingly, this section includes
supplemental narratives that describe the 2024 executive compensation program for our Named Executive Officer.
The following table summarizes all compensation
awarded to, earned by or paid to our Named Executive Officer, Steven A. Shallcross, during the fiscal years presented below.
| |
| | |
| | |
| | |
| | |
All Other | | |
| |
Name and Principal | |
| | |
| | |
| | |
Options | | |
Compensation | | |
| |
Position | |
Year | | |
Salary ($)(1) | | |
Bonus ($)(2) | | |
Awards ($)(3) | | |
($)(4) | | |
Total ($) | |
Steven Shallcross | |
| 2024 | | |
$ | 644,963 | | |
$ | 200,000 | | |
$ | — | | |
$ | 31,350 | | |
$ | 876,313 | (5) |
Chief Executive Officer | |
| 2023 | | |
$ | 614,250 | | |
$ | 350,000 | | |
$ | 278,450 | | |
$ | 29,213 | | |
$ | 1,271,913 | (5) |
and Chief Financial Officer | |
| | | |
| | | |
| | | |
| | | |
| | | |
| | |
| (1) | Mr. Shallcross’ annual salary
was $614,250 commencing January 1, 2023 and $644,963 commencing January 1, 2024. |
| (2) | Amounts represent annual cash bonuses
earned for the applicable fiscal year. The annual cash bonuses are paid in the first quarter
of the calendar year following the year to which the cash bonus relates. |
| (3) | Amount reflects the grant date
fair value of the Named Executive Officer’s stock options, calculated in accordance
with FASB ASC Topic 718. For a discussion of the assumptions used in calculating these values,
see Note 5 to our consolidated financial statements incorporated by reference in this prospectus.
In December 2023, Mr. Shallcross was issued options to purchase 700,000 shares of common
stock, respectively. There were no option issued to the Named Executive Officer during 2024. |
| (4) | The all other compensation column
is comprised of vacation accrual paid, and the portion of medical, dental and vision premiums
paid by us on behalf of our Named Executive Officer. These benefits are offered to all Theriva
Biologics’ employees who work at least 17.5 hours per week. |
| (5) | Amount for the year ended December
31, 2024 excludes salary of $152,250 and a bonus of $45,000 paid to the wife of Mr. Shallcross
during the year ended December 31, 2024. |
Narrative Disclosure to Summary Compensation Table
Overview of Our Compensation Program
A. Philosophy and Objectives
The Compensation Committee seeks to attract and retain superior
executive talent by offering competitive base salaries, bonuses and long-term incentives. The Compensation Committee’s philosophy
is to deliver higher rewards for superior performance and consequences for underperformance. It is also the Compensation Committee’s
practice to provide a balanced mix of cash and equity-based compensation that aligns both the short and long-term interests of our executives
with that of our stockholders. Our executive compensation program is based on the following philosophies and objectives:
| · | Compensation
Should Align with Stockholders’ Interests — The Compensation Committee believes
that executives’ interests should be aligned with those of the stockholders. In years
prior to 2024, executives were granted stock options so that their total compensation was
tied directly to value realized by our stockholders. Executive bonuses are tied directly
to the achievement of performance goals that the Compensation Committee believes will ultimately
drive stockholder value creation. |
| · | Compensation
is Competitive — The Compensation Committee seeks to provide a total compensation package
that attracts, motivates and retains the executive talent that we need in order to maximize
our return to stockholders. To accomplish this objective, executive compensation is reviewed
annually to ensure that compensation levels are competitive and reasonable relative to our
level of performance and to the compensation opportunities provided by comparable companies
with which we compete for talent. |
| · | Compensation
Motivates and Rewards the Achievement of Goals — Our executive compensation program
is designed to appropriately reward both individual and collective performance that meets
and exceeds our annual, long-term and strategic goals. To accomplish this objective, a substantial
percentage of total compensation is variable and “at risk,” both through annual
incentive compensation in the form of cash bonuses and, in years prior to 2024, the granting
of long-term incentive awards. |
B. Oversight of Executive Compensation
Role of the Compensation Committee
Pursuant to the terms of its charter, the
Compensation Committee is responsible for the review of all aspects of our executive compensation program and makes decisions regarding
the compensation of the Named Executive Officer. Our Named Executive Officer for the year ended December 31, 2024 was Steven Shallcross,
our Chief Executive Officer who also serves as our Chief Financial Officer.
The Compensation Committee’s responsibilities
include but are not limited to the following:
| · | Establishing
on an annual basis the performance goals and objectives for purposes of determining the compensation
of our Chief Executive Officer and other senior executive officers. |
| · | Evaluating
the Chief Executive Officer’s and other senior executive officers’ performance
at least annually in light of those goals and objectives, and based upon these evaluations
setting the compensation level for those officers. |
| · | Reviewing
the competitive position of, and making recommendations to, the Board of Directors with respect
to the cash-based and equity-based compensation plans and our programs relating to compensation
and benefits. |
| · | Overseeing
the administration of our stock option plan and incentive compensation plans, making recommendations
to the Board of Directors regarding the granting of options and incentives and otherwise
assisting the Board of Directors in administering awards under these plans. |
| · | Reviewing
the financial performance and operations of our major benefit plans. |
Additional information regarding the Compensation
Committee’s responsibilities is set forth in its charter, which is posted on our website at www.therivabio.com. Information
contained on our website is intended for informational purposes only and is not incorporated by reference into this prospectus, and it
should not be considered to be part of this prospectus or the registration statement of which this prospectus forms a part.
Role of the Chief Executive Officer
Our Chief Executive Officer makes recommendations
to the Compensation Committee regarding the compensation of any other Named Executive Officers. The Chief Executive Officer does not
participate in any discussions or processes concerning his own compensation and participates in a non-voting capacity in discussions
or processes concerning the compensation of our other members of management. In addition to our Chief Executive Officer, other members
of our management and consultants also attend Compensation Committee meetings from time to time and may take part in discussions of executive
compensation.
C. Program Design
The Compensation Committee uses a simple and
straightforward approach in compensating our Named Executive Officer in which base salary, annual incentives and stock options are the
principal components. In addition, executive officers generally participate in the same benefit programs as other full-time employees.
Our executive compensation program is designed
to provide executives with a reasonable level of fixed compensation through base salary and benefits, and an opportunity to earn incentive
compensation through the annual and long-term incentive programs based on a mix of individual and corporate performance, individual performance
and the value of our stock. We do not currently have formal policies for allocating compensation among base salary, performance-based
bonus and equity awards. Instead our Compensation Committee uses its judgment to establish a total direct compensation opportunity for
each Named Executive Officer that is a mix of current, short-term and long-term incentive compensation and cash and non-cash compensation
that it believes appropriate to achieve the goals of our executive compensation program and corporate objectives. Our target pay mix
places a significant emphasis on performance based variable compensation. The incentive plans are designed to pay well when performance
meets or exceeds expectations and pay little or no incentive if performance is below expectations.
In designing and implementing our executive
compensation program, our Compensation Committee considers our company’s operating and financial objectives, including our risk
profile, and the effect that its executive compensation decisions will have on encouraging our executive officers to take an appropriate
level of business risk consistent with our overall goal of enhancing long-term stockholder value. In particular, the Compensation Committee
considers those business risks identified in our risk factors and the known trends and uncertainties identified in our management discussion
and analysis and considers how our executive compensation program serves to achieve our operating and financial objectives while at the
same time mitigating any incentives for our executive officers to engage in excessive risk-taking to achieve short-term results that
may not be sustainable in the long-term.
Target compensation comprises base salary
and performance based variable compensation, including targeted cash bonus amounts and equity-based compensation. As an executive’s
level of responsibility increases, the Compensation Committee generally targets a greater portion of the executive’s compensation
to be contingent upon performance in the form of variable compensation. For example, historically our named executive officers have a
higher percentage of compensation at risk (and thus greater upside and downside potential) relative to our other employees. The Compensation
Committee believes this is appropriate because our named executive officers have the greatest influence on our performance.
During 2024, the salary for our Chief Executive
Officer who also serves as our Chief Financial Officer was 67% of his target compensation package and performance based variable compensation
comprised 33% of his target compensation. The increase in the percentage of non-variable compensation was due to the fact that no equity
awards were granted in 2024. Of the performance based variable compensation none was equity-based compensation and all of the variable
compensation was his target cash bonus.The Compensation Committee anticipates awarding equity awards for services provided in 2024 during
the first quarter of 2025.
D. Compensation Review Process
The Compensation Committee annually reviews
compensation for our Named Executive Officers. The Compensation Committee considers the executive’s role and responsibilities,
corporate and individual performance, and industry-wide compensation practices and trends for other companies of similar size. This approach
is used to set base salaries, bonuses, stock option award levels and the mix of compensation elements.
We strive to attract and retain the most highly
qualified executive officers in an extremely competitive market. Our Compensation Committee believes that it is important when making
its compensation decisions to be informed as to the competitive market for executive talent, including the current practices of comparable
public companies with which we compete for such talent. Consequently, in December 2023 our Compensation Committee reviewed an executive
compensation report prepared by Meridian Compensation Partners, LLC (“Meridian”) at the Compensation Committee’s request.
With respect to its analysis of the compensation of the Chief Executive Officer, the Compensation Committee took into account that our
Chief Executive Officer also serves as our Chief Financial Officer, which is not typical for most companies.
While the Compensation Committee does take
into consideration the data it reviewed, the Committee does not attempt to benchmark our executive compensation against any specific
level, range, or percentile of compensation paid at any other companies, does not apply any specific measures of internal or external
pay equity in reaching its conclusions, and does not employ tally sheets, wealth accumulation, or similar tools in its analysis. Rather,
the Compensation Committee reviews compensation data from the report mentioned above as reference points in making executive compensation
decisions especially in light of the fact that our Chief Executive Officer is also performing the role of Chief Financial Officer. The
Compensation Committee’s general aim is for our compensation to remain competitive with the market, falling above or below the
median of the market data as appropriate based on corporate and individual executive performance, and other factors deemed to be appropriate.
Competitive market positioning is only one of several factors, as described below, that the Compensation Committee considers in making
compensation decisions, and therefore individual Named Executive Officer compensation may fall at varying levels as compared to the market
data.
Our Compensation Committee values the opinion
of our stockholders. At our 2022 Annual Meeting of Stockholders approximately 97% of the shares voted (excluding broker non-votes) were
cast in support of our fiscal 2022 executive compensation and related disclosures. At that time, our Compensation Committee viewed those
voting results as broad stockholder support for our executive compensation program and consequently made no material changes to the program
or to our compensation policies. Our Compensation Committee will continue to consider input from stockholders, including through advisory
votes on executive compensation, in making compensation decisions and reviewing executive compensation programs and policies.
We currently hold our advisory vote to approve
the compensation of our named executive officers (“Say-on-Pay vote”) every three years. Stockholders have an opportunity
to cast an advisory vote on the frequency of the Say-on-Pay vote at least every six years, and the next advisory vote on the frequency
of the Say-on-Pay vote will be at our 2025 Annual Meeting of Stockholders.
E. Components of Compensation
We provide four compensation components to
Named Executive Officers:
| · | bonuses
based on the achievement of specified goals and objectives; |
| · | long-term
incentives; and |
1. Base Salaries
We provide our Named Executive Officers a
base salary commensurate with their position, responsibilities and experience. In setting the base salary, the Compensation Committee
considers the scope and accountability associated with each Named Executive Officer’s position and such factors as performance
and experience of each Named Executive Officer. We design base pay to provide the essential reward for an employee’s work that
is required to be competitive in attracting talent. Once base pay levels are initially determined, increases in base pay may be provided
to recognize an employee’s specific performance achievements or expansion of responsibilities. The base salaries are targeted to
be competitive with other similar biotechnology companies. Base salaries for the Named Executive Officers are set by their respective
employment contracts and are reviewed annually by the Compensation Committee referencing an executive compensation report. The Compensation
Committee engaged Meridian to provide such a report in 2023, and Mr. Shallcross’ compensation for 2024 was determined by the Compensation
Committee taking into account the findings and recommendations of this report. Mr. Shallcross’ base salary was $614,250 for the
year ended December 31, 2023. Mr. Shallcross received a 5% merit increase to $644,963 for the year ended December 31, 2024, and on December
13, 2024 received a 3.5% merit increase to $667,536 for the 2025 fiscal year.
2. Bonuses
The Compensation Committee believes that the
granting of a bonus is appropriate to motivate our Named Executive Officers. The bonuses are to be rewarded in the discretion of the
Compensation Committee and the Board of Directors, based on a review of achievements for the year. The Compensation Committee focuses
on individual performance, which enables the Compensation Committee to differentiate among executives and emphasize the link between
personal performance and compensation. The Compensation Committee also used information from the executive compensation report prepared
by Meridian in December 2023 in determining bonus amounts. Although the Compensation Committee does not use any fixed formula in
determining bonuses, it does link bonuses to objectives the Compensation Committee deems important such as effective M&A strategy
and implementation, financings, and achievement of clinical milestones.
| · | Mr.
Shallcross’ employment agreement provided that he was eligible for a target bonus of
up to fifty percent (50%) of his base salary in cash. After considering Mr. Shallcross’
achievement relative to performance goals in 2024, the Compensation Committee approved a
$200,000 cash bonus, or 65% of target. |
3. Long-Term Incentives
The Compensation Committee believes that a
substantial portion of our Named Executive Officer’s compensation should be awarded in equity-based compensation since equity-based
compensation is directly linked to the interests of stockholders. The Compensation Committee has elected to grant stock options to the
Named Executive Officers and other key employees as the primary long-term incentive vehicle. In making this determination, the Compensation
Committee considered a number of factors including: the accounting impact, potential value of stock option grants versus other equity
instruments and cash incentives, and the alignment of equity participants with stockholders. The Compensation Committee determined to
grant stock options to:
| · | enhance
the link between the creation of stockholder value and executive compensation; |
| · | provide
an opportunity for equity ownership; |
| · | act
as a retention tool; and |
| · | provide
competitive levels of total compensation. |
In 2023, the Compensation Committee approved
grants of options exercisable for 700,000 shares to Mr. Shallcross. The options had a grant date of December 14, 2023, an exercise price
of $0.59, vest pro rata on a monthly basis over 36 months and expire seven years from date of grant. No options were granted to Mr. Shallcross
in 2024. The Compensation Committee anticipates awarding equity awards for services provided in 2024 during the first quarter of 2025.
The Compensation Committee reviews the performance,
potential burn rates and dilution levels to create an option pool that may be awarded to employee participants. Grants to the Named Executive
Officers are determined by the Compensation Committee after reviewing market data, including the reports and analysis discussed above
and after considering each executive’s performance, role and responsibilities.
The Compensation Committee does not seek to
time equity grants to take advantage of information, either positive or negative, about our company that has not been publicly disclosed.
Option grants are effective on the date the award determination is made by the Compensation Committee and the exercise price of options
is the closing market price of our common stock on the business day of the grant or, if the grant is made on a weekend or holiday, on
the prior business day.
4. Benefits
Named Executive Officers are eligible to participate
in our standard medical, dental, vision, disability insurance, life insurance plans and other health and welfare plans provided to other
full-time employees.
Each of our Named Executive Officers are entitled
to participate in our 401(k) contributory defined contribution plan.
Pension Benefits
We do not currently provide pension arrangements
or post-retirement health coverage for our employees, although we may consider such benefits in the future.
Retirement Benefits
Each of our Named Executive Officers is eligible
to participate in our 401(k) contributory defined contribution plan. Pursuant to our 401(k) plan, all eligible employees, including
our Named Executive Officers, are provided with a means of saving for their retirement. We currently match all participating employee
contributions up to maximum of 4 percent of compensation which vest immediately.
Nonqualified Deferred Compensation
We do not provide any nonqualified deferred
compensation plans to our employees, although we may consider such benefits in the future.
Outstanding Equity Awards at Fiscal Year End
The table below reflects all outstanding equity
awards made to each of the Named Executive Officers that are outstanding at December 31, 2024. We currently grant stock-based awards
pursuant to our 2020 Stock Incentive Plan (the “2020 Stock Plan”) and have outstanding awards to Mr. Shallcross under our
2010 Stock Incentive Plan (the “2010 Stock Plan”).
| |
| | |
Number of | | |
Number of | | |
| | |
|
| |
| | |
Securities | | |
Securities | | |
| | |
|
| |
| | |
Underlying | | |
Underlying | | |
| | |
|
| |
| | |
Unexercised | | |
Unexercised | | |
Option | | |
|
| |
| | |
Options | | |
Options | | |
Exercise | | |
Option |
Name | |
Grant Date(1) | | |
Exercisable | | |
Unexercisable | | |
Price ($) | | |
Expiration Date |
Steven Shallcross | |
| 12/14/2023 | | |
| 9,334 | | |
| 18,667 | | |
$ | 14.75 | | |
12/15/2030 |
| |
| 12/15/2022 | | |
| 12,667 | | |
| 6,334 | | |
| 14.50 | | |
12/15/2029 |
| |
| 12/23/2021 | | |
| 2,601 | | |
| — | | |
$ | 82.75 | | |
12/23/2028 |
| |
| 12/30/2020 | | |
| 1,801 | | |
| — | | |
$ | 104.25 | | |
12/30/2027 |
| |
| 12/04/2019 | | |
| 1,801 | | |
| — | | |
$ | 104.50 | | |
12/04/2026 |
| |
| 12/06/2018 | | |
| 801 | | |
| — | | |
$ | 172.25 | | |
12/06/2025 |
| |
| 06/01/2015 | | |
| 104 | | |
| — | | |
$ | 18,900.00 | | |
06/01/2025 |
| (1) | Options vested or will vest pro
rata, on a monthly basis, over 36 months beginning on their respective grant dates. |
Employment Agreements
Steven A. Shallcross, Chief Executive Officer, Chief Financial
Officer
On January 3, 2022, we entered into a
three-year employment agreement with Mr. Shallcross (the “2022 Shallcross Employment Agreement”) to serve as our Chief
Executive Officer and to continue to serve as our Chief Financial Officer. The 2022 Shallcross Employment Agreement replaced the
prior employment agreement with us that Mr. Shallcross entered into on December 6, 2018, as amended December 5, 2019. Mr. Shallcross
has served as our Chief Financial Officer since June 1, 2015, initially pursuant to the terms of a two year employment agreement
that we entered with him on April 28, 2015 (the “Initial Shallcross Employment Agreement”) and then pursuant to an
employment agreement we entered into with him on December 6, 2018, which replaced the Initial Shallcross Agreement (the
“Amended Shallcross Employment Agreement”). Mr. Shallcross does not receive additional compensation for service as our
director. The 2022 Shallcross Employment Agreement expired on January 3, 2025. We are currently negotiating a new employment
agreement with Mr. Shallcross while Mr. Shallcross continues to serve as our Chief Executive Officer and Chief Financial Officer and
receive the same compensation that he received pursuant to the 2022 Shallcross Employment Agreement. The material terms of the 2022 Shallcross Employment Agreement are set forth below.
Pursuant to the 2022
Shallcross Employment Agreement, Mr. Shallcross was initially entitled to an annual base salary of $585,000 which was
increased to $614,250 for the year ended December 31, 2023, increased on December 14, 2023 to $644,963 to reflect a 5% merit
increase increased on December 13, 2024 to $667,526 to reflect a 3.5% merit increase. Mr. Shallcross is also eligible to receive an
annual cash performance bonus targeted at fifty percent (50%) of his annual base salary as well as discretionary annual equity
awards pursuant to the Company’s incentive plans. The annual bonus will be based upon the assessment of the Board of Mr.
Shallcross’s performance. The 2022 Shallcross Employment Agreement also includes confidentiality obligations and inventions
assignments by Mr. Shallcross and non-solicitation and non-competition provisions.
The 2022 Shallcross Employment Agreement has a stated
term of three years but may be terminated earlier pursuant to its terms. If Mr. Shallcross’s employment is terminated for any reason,
he or his estate as the case may be, will be entitled to receive the unpaid base salary through the date of termination and accrued vacation,
any unpaid annual bonus earned with respect to any calendar year ending on or preceding the date of termination, expense reimbursement
and any other entitlements accrued by him to the extent not previously paid (the “Accrued Obligations”); provided, however,
that if his employment is terminated (i) by the us without Cause or by Mr. Shallcross for Good Reason (as each is defined in the Employment
Agreement) then, subject to him executing a general release in form acceptable to the us that becomes effective, in addition to paying
the Accrued Obligations, (a) we will continue to pay his then current base salary and if the Executive timely elects continued coverage
under COBRA, the Company will continue to provide benefits at least equal to those that were provided at the time of termination for
a period of twelve (12) months and (b) all unvested equity awards will vest and he shall have the right to exercise any such vested equity
awards until the earlier of eighteen (18) months after termination or the remaining term of the awards; or (ii) by reason of his death
or Disability (as defined in the Employment Agreement), then in addition to paying the Accrued Obligations, Mr. Shallcross or his estate
would have the right to exercise any vested options until the earlier of six (6) months after termination or the remaining term of the
awards. In such event, if Mr. Shallcross commenced employment with another employer and becomes eligible to receive medical or other
welfare benefits under another employer-provided plan, the medical and other welfare benefits to be provided by the Company as described
herein would terminate.
The 2022 Shallcross Employment Agreement
provides that upon the closing of a “Change in Control” (as defined in the 2022 Shallcross Employment Agreement), all unvested
options shall immediately vest and the time period that Mr. Shallcross will have to exercise all vested stock options and other
awards that Mr. Shallcross may have will be equal to the shorter of: (i) eighteen (18) months after termination, or (ii) the
remaining term of the award(s). If within one (1) year after the occurrence of a Change in Control, Mr. Shallcross terminates his
employment for “Good Reason” or the Company terminates Mr. Shallcross’s employment for any reason other than
death, disability or Cause, Mr. Shallcross will be entitled to receive: (i) the portion of his base salary for periods prior to the
effective date of termination accrued but unpaid (if any); (ii) all unreimbursed expenses (if any); (iii) an aggregate amount (the
“Change in Control Severance Amount”) equal to two (2) times the sum of his base salary plus an amount equal to the
bonus that would be payable if the “target” level performance were achieved under the Company’s annual bonus plan
(if any) in respect of the fiscal year during which the termination occurs (or the prior fiscal year if bonus levels have not yet
been established for the year of termination) subject to him executing a general release in form acceptable to the Company that
becomes effective. If within two (2) years after the occurrence of a Change in Control, Mr. Shallcross terminates his employment for
“Good Reason” or the Company terminates Mr. Shallcross’s employment for any reason other than death, disability or
Cause, Mr. Shallcross will be entitled to also receive for the period of two (2) consecutive years commencing on the date of such
termination of his employment, medical, dental, life and disability insurance coverage for him and the members of his family that
are not less favorable to him than the group medical, dental, life and disability insurance coverage carried by the Company for him
subject to him executing a general release in form acceptable to the Company that becomes effective. The Change in Control Severance
Amount is to be paid in a lump sum if the Change in Control event constitutes a “change in the ownership” or a
“change in the effective control” of the Company or a “change in the ownership of a substantial portion of a
corporation’s assets” (each within the meaning of Section 409A of the Internal Revenue Code (“Rule 409A”)),
or in 48 substantially equal payments, if the Change in Control event does not so comply with Section 409A.
Clawback Policy
The Board has adopted a clawback policy which
allows us to recover performance-based compensation, whether cash or equity, from a current or former executive officer in the event
of an Accounting Restatement. The clawback policy defines an Accounting Restatement as an accounting restatement of our financial statements
due to our material noncompliance with any financial reporting requirement under the securities laws. Under such policy, we may recoup
incentive-based compensation previously received by an executive officer that exceeds the amount of incentive-based compensation that
otherwise would have been received had it been determined based on the restated amounts in the Accounting Restatement.
The Board has the sole discretion to determine
the form and timing of the recovery, which may include repayment, forfeiture and/or an adjustment to future performance-based compensation
payouts or awards. The remedies under the clawback policy are in addition to, and not in lieu of, any legal and equitable claims available
to the Company. The clawback policy is annexed to this Annual Report as an exhibit.
Company Policies and Practices Related to the Grant of Certain
Equity Awards Close in Time to the Release of Material Nonpublic Information
We do not have a policy on the timing of awards
of options in relation to the disclosure by us of material nonpublic information. During the fiscal year ended December 31, 2024,
no Named Executive Officer was awarded stock options, and we did not time the disclosure of material nonpublic information for the purpose
of affecting the value of executive compensation.
Equity Compensation Plan Information
The following table sets forth information
about the securities authorized for issuance under our equity compensation plans for the fiscal year ended December 31, 2024.
| |
Number of
Securities to be
Issued Upon
Exercise
of
Outstanding
| | |
Weighted-Average
Exercise Price of
Outstanding
| | |
Number of Securities
Remaining Available
for Future
Issuance
Under Equity
Compensation
| |
Plan Category | |
Options | | |
Options | | |
Plans | |
Equity compensation plans approved by stockholders: | |
| | | |
| | | |
| | |
2001 Stock Incentive Plan | |
| — | | |
$ | — | | |
| — | |
2007 Stock Incentive Plan | |
| — | | |
$ | — | | |
| — | |
2010 Stock Incentive Plan | |
| 7,670 | | |
$ | 377.24 | | |
| — | |
2020 Stock Incentive Plan | |
| 167,364 | | |
| 21.78 | | |
| 2,332,636 | |
Equity compensation plans not approved by stockholders | |
| N/A | | |
| N/A | | |
| N/A | |
Total | |
| 175,034 | | |
$ | 36.88 | | |
| 2,332,636 | |
Compensation of Directors
The following table sets forth information
for the fiscal year ended December 31, 2024 regarding the compensation of our directors who at December 31, 2024 were
not also our Named Executive Officer.
| |
Fees Earned | | |
| | |
| | |
| |
| |
or | | |
Option | | |
Other | | |
| |
Name | |
Paid in Cash | | |
Awards(1)) | | |
Compensation | | |
Total | |
Jeffrey J. Kraws | |
$ | 180,250 | | |
$ | — | | |
$ | — | | |
$ | 180,250 | |
| |
| | | |
| | | |
| | | |
| | |
John Monahan | |
$ | 77,750 | | |
$ | — | | |
$ | — | | |
$ | 77,750 | |
| |
| | | |
| | | |
| | | |
| | |
Jeffrey Wolf | |
$ | 70,750 | | |
$ | — | | |
$ | — | | |
$ | 70,750 | |
| (1) | As of December 31, 2024, the
following are the outstanding aggregate number of option awards held by each of our directors
who were not also our Named Executive Officer: |
| |
Option | |
| |
Awards | |
Name | |
(#) | |
Jeffrey J. Kraws | |
| 11,118 | |
| |
| | |
John Monahan | |
| 9,900 | |
| |
| | |
Jeffrey Wolf | |
| 11,118 | |
Our board members were compensated based on
the following policies during 2024:
| · | Our
independent, non-executive Chairman of the Board of Directors received an annual cash retainer
of $154,000. |
| · | Other
non-employee members of the Board of Directors were entitled to an annual cash retainer of
$47,000. |
| · | Non-employee
directors were entitled to annual cash fees of $7,500, $5,000 and $3,750 for service as a
member of the Audit, Compensation and Nominations Committees, respectively. |
| · | Non-employee
directors were entitled to an additional annual cash fee of $15,000, $10,000 and $7,500 for
service as Chairman of the Audit, Compensation and Nominations Committees. |
In setting 2024 compensation for directors,
the Compensation Committee relied on a report prepared by Meridian in December 2023.
DESCRIPTION
OF Capital Stock
The following is a description of the material terms of our capital
stock. This is a summary only and does not purport to be complete. It is subject to and qualified in its entirety by reference to our
Articles of Incorporation and our Bylaws, each of which are incorporated by reference as an exhibit to the registration statement of
which this prospectus forms a part. We encourage you to read our Articles of Incorporation, our Bylaws and the applicable provisions
of the Nevada Revised Statute (the “NRS”), for additional information.
Our authorized capital stock consists of:
| · | 350,000,000
shares of Common Stock, par value $0.001 per share; and |
| · | 10,000,000
shares of preferred stock, par value $0.001 per share. |
Common Stock
Outstanding Shares. As of January 17, 2025, there were
2,782,449 shares of Common Stock outstanding.
Voting Rights. The holders of the Common Stock are entitled
to one vote for each share held of record on all matters submitted to a vote of the stockholders, including the election of directors,
and do not have cumulative voting rights. Accordingly, the holders of a majority of the shares of the Common Stock entitled to vote in
any election of directors can elect all of the directors standing for election.
Dividend Rights. Subject to preferences that may be applicable
to any then outstanding preferred stock, the holders of Common Stock are entitled to receive dividends, if any, as may be declared from
time to time by our board of directors out of legally available funds.
Liquidation Rights. In the event of our liquidation, dissolution
or winding up, holders of the Common Stock will be entitled to share ratably in the net assets legally available for distribution to
stockholders after the payment of all of our debts and other liabilities, subject to the satisfaction of any liquidation preference granted
to the holders of any then outstanding shares of preferred stock.
Other Rights and Preferences. The holders of the Common Stock
have no preemptive, conversion or subscription rights, and there are no redemption or sinking fund provisions applicable to the Common
Stock. The rights, preferences and privileges of the holders of the Common Stock are subject to, and may be adversely affected by, the
rights of the holders of shares of any series of our preferred stock that we may designate and issue in the future.
Fully Paid and Nonassessable. All of our outstanding shares
of Common Stock are fully paid and nonassessable.
Preferred Stock
Our Board of Directors has the authority, without action by our stockholders,
to designate and issue up to 10,000,000 shares of preferred stock in one or more series or classes and to designate the rights, preferences
and privileges of each series or class, which may be greater than the rights of the Common Stock. It is not possible to state the actual
effect of the issuance of any shares of preferred stock upon the rights of holders of the Common Stock until our Board of Directors determines
the specific rights of the holders of the preferred stock. However, the effects might include:
| · | restricting
dividends on the Common Stock; |
| · | diluting
the voting power of the Common Stock; |
| · | impairing
liquidation rights of the Common Stock; or |
| · | delaying
or preventing a change in control of us without further action by our stockholders. |
The Board of Directors’ authority to issue preferred stock without
stockholder approval could make it more difficult for a third-party to acquire control of our company and could discourage such attempt.
We have 120,000 shares of preferred stock designated as Series A Convertible Preferred Stock, 15,723 shares of preferred stock designated
as Series B Convertible Preferred Stock, 275,000 shares of preferred stock designated as Series C Convertible Preferred Stock,
and 100,000 shares of preferred stock designated as Series D Convertible Preferred Stock. We currently do not have any shares of
preferred stock outstanding and have no present plans to issue any shares of preferred stock.
Anti-Takeover Effects of Nevada Law
The provisions of NRS, our Articles of Incorporation and our Bylaws
described below may have the effect of delaying, deferring or discouraging another party from acquiring control of us.
Business Combinations
The “business combination” provisions of Sections 78.411
to 78.444, inclusive, of the NRS generally prohibit a Nevada corporation with at least 200 stockholders from engaging in various “combination”
transactions with any interested stockholder for a period of two years after the date of the transaction in which the person became an
interested stockholder, unless the transaction is approved by the board of directors prior to the date the interested stockholder obtained
such status or the combination is approved by the board of directors and thereafter is approved at a meeting of the stockholders by the
affirmative vote of stockholders representing at least 60% of the outstanding voting power held by disinterested stockholders, and extends
beyond the expiration of the two-year period, unless:
| · | the
combination was approved by the board of directors prior to the person becoming an interested
stockholder or the transaction by which the person first became an interested stockholder
was approved by the board of directors before the person became an interested stockholder
or the combination is later approved by a majority of the voting power held by disinterested
stockholders; or |
| · | if
the consideration to be paid by the interested stockholder is at least equal to the highest
of: (a) the highest price per share paid by the interested stockholder within the two
years immediately preceding the date of the announcement of the combination or in the transaction
in which it became an interested stockholder, whichever is higher, (b) the market value
per share of Common Stock on the date of announcement of the combination and the date the
interested stockholder acquired the shares, whichever is higher, or (c) for holders
of preferred stock, the highest liquidation value of the preferred stock, if it is higher. |
A “combination” is generally defined to include mergers
or consolidations or any sale, lease exchange, mortgage, pledge, transfer, or other disposition, in one transaction or a series of transactions,
with an “interested stockholder” having: (a) an aggregate market value equal to 5% or more of the aggregate market value
of the assets of the corporation, (b) an aggregate market value equal to 5% or more of the aggregate market value of all outstanding
shares of the corporation, (c) 10% or more of the earning power or net income of the corporation, and (d) certain other transactions
with an interested stockholder or an affiliate or associate of an interested stockholder.
In general, an “interested stockholder” is a person who,
together with affiliates and associates, owns (or within two years, did own) 10% or more of a corporation’s voting stock. The statute
could prohibit or delay mergers or other takeover or change in control attempts and, accordingly, may discourage attempts to acquire
our company even though such a transaction may offer our stockholders the opportunity to sell their stock at a price above the prevailing
market price.
Control Share Acquisitions
The “control share” provisions of Sections 78.378 to 78.3793,
inclusive, of the NRS apply to “issuing corporations” that are Nevada corporations with at least 200 stockholders, including
at least 100 stockholders of record who are Nevada residents, and that conduct business directly or indirectly in Nevada. The control
share statute prohibits an acquirer, under certain circumstances, from voting its shares of a target corporation’s stock after
crossing certain ownership threshold percentages, unless the acquirer obtains approval of the target corporation’s disinterested
stockholders. The statute specifies three thresholds: one-fifth or more but less than one-third, one-third but less than a majority,
and a majority or more, of the outstanding voting power. Generally, once an acquirer crosses one of the above thresholds, those shares
in an offer or acquisition and acquired within 90 days thereof become “control shares” and such control shares are deprived
of the right to vote until disinterested stockholders restore the right. These provisions also provide that if control shares are accorded
full voting rights and the acquiring person has acquired a majority or more of all voting power, all other stockholders who do not vote
in favor of authorizing voting rights to the control shares are entitled to demand payment for the fair value of their shares in accordance
with statutory procedures established for dissenters’ rights.
A corporation may elect to not be governed by, or “opt out”
of, the control share provisions by making an election in its articles of incorporation or bylaws, provided that the opt-out election
must be in place on the 10th day following the date an acquiring person has acquired a controlling interest, that is, crossing any of
the three thresholds described above. We have not opted out of the control share statutes, and will be subject to these statutes if we
are an “issuing corporation” as defined in such statutes.
The effect of the Nevada control share statutes is that the acquiring
person, and those acting in association with the acquiring person, will obtain only such voting rights in the control shares as are conferred
by a resolution of the stockholders at an annual or special meeting. The Nevada control share law, if applicable, could have the effect
of discouraging takeovers of our company.
Articles of Incorporation and Bylaws
Our Articles of Incorporation and Bylaws provide that:
| · | the
authorized number of directors is determined by our board of directors; |
| · | directors
may be removed only by the affirmative vote of the holders of at least a majority of our
voting stock, whether for cause or without cause; |
| · | our
Bylaws may be amended or repealed by our board of directors or by the affirmative vote of
our stockholders; |
| · | special
meetings of the stockholders may be called by Chairman of the board, if any, the Vice Chairman
of the board, if any, or the President; |
| · | our
board of directors may fill vacancies on the board of directors; |
| · | our
board of directors will be authorized to issue, without stockholder approval, preferred stock,
the rights of which will be determined at the discretion of the board of directors and that,
if issued, could operate as a “poison pill” to dilute the stock ownership of
a potential hostile acquirer to prevent an acquisition that our board of directors does not
approve; |
| · | our
stockholders do not have cumulative voting rights, and therefore our stockholders holding
a majority of the shares of Common Stock outstanding will be able to elect all of our directors;
and |
| · | our
stockholders must comply with advance notice provisions to bring business before or nominate
directors for election at a stockholder meeting. |
Potential Effects of Authorized but Unissued Stock
We have shares of Common Stock and preferred stock available for future
issuance without stockholder approval. We may utilize these additional shares for a variety of corporate purposes, including future public
offerings to raise additional capital, to facilitate corporate acquisitions or payment as a dividend on the capital stock.
The existence of unissued and unreserved Common Stock may enable our
board of directors to issue shares to persons friendly to current management.
Limitations of Director Liability and Indemnification of Directors,
Officers and Employees
NRS 78.138 provides that directors of a corporation is not individually
liable to the corporation or its stockholders or creditors for any damages as a result of any act or failure to act in his or her capacity
as a director or officer unless: (a) the presumption that directors and officers acted in good faith on an informed basis with a
view toward the best interest of the corporation has been rebutted and (b) it is proven that:
| · | The
director’s or officer’s act or failure to act constituted a breach of his or
her fiduciary duties as a director or officer; and |
| · | such
breach involved intentional misconduct, fraud or a knowing violation of law. |
Our Articles of Incorporation and Bylaws provide that we will indemnify
our directors and officers to the fullest extent permitted by law and may indemnify employees and other agents. Our Articles of Incorporation
also provide that we are obligated to advance expenses incurred by a director or officer in advance of the final disposition of any action
or proceeding.
We have obtained a policy of directors’ and officers’
liability insurance.
We have entered into separate indemnification agreements with our
directors and officers. These agreements, among other things, require us to indemnify our directors and officers for any and all expenses
(including reasonable attorneys’ fees, retainers, court costs, transcript costs, fees of experts, witness fees, travel expenses,
duplicating costs, printing and binding costs, telephone charges, postage, delivery service fees) judgments, fines and amounts paid in
settlement actually and reasonably incurred by such directors or officers or on his or her behalf in connection with any action or proceeding
arising out of their services as one of our directors or officers, or any of our subsidiaries or any other company or enterprise to which
the person provides services at our request provided that such person follows the procedures for determining entitlement to indemnification
and advancement of expenses set forth in the indemnification agreement. We believe that these bylaw provisions and indemnification agreements
are necessary to attract and retain qualified persons as directors and officers.
The limitation of liability and indemnification provisions in our
Articles of Incorporation and Bylaws may discourage stockholders from bringing a lawsuit against directors for breach of their fiduciary
duties. They may also reduce the likelihood of derivative litigation against directors and officers, even though an action, if successful,
might provide a benefit to us and our stockholders. Our results of operations and financial condition may be harmed to the extent we
pay the costs of settlement and damage awards against directors and officers pursuant to these indemnification provisions.
Insofar as indemnification for liabilities arising under the Securities
Act may be permitted to directors, officers or persons controlling us, we have been informed that, in the opinion of the SEC, such indemnification
is against public policy as expressed in the Securities Act and is therefore unenforceable.
At present, there is no pending litigation or proceeding involving
any of our directors or officers as to which indemnification is required or permitted, and we are not aware of any threatened litigation
or proceeding that may result in a claim for indemnification.
Listing of the Common Stock on the NYSE American LLC
The Common Stock is listed for trading on the NYSE American LLC under
the symbol “TOVX.”
Transfer Agent and Registrar
The transfer agent and registrar for the Common Stock is Equiniti
Trust Company.
Stock Options
As of January 17, 2025, we had options outstanding to purchase
an aggregate of 175,034 shares of Common Stock that were issued under our equity compensation plans. As of January 17, 2025,
there were 2,332,636 shares of Common Stock reserved for future issuance under our equity incentive plan.
Warrants
As of January 17, 2025, we had warrants outstanding to purchase
an aggregate of 1,428,600 shares of Common Stock with a weighted average exercise price of $2.00 per share.
DESCRIPTION
OF SECURITIES to be Registered
We are offering up to 6,756,756 shares of Common Stock, or Pre-Funded
Warrants in lieu of shares of Common Stock, along with Common Warrants to purchase up to 6,756,756 shares of Common Stock. For each
Pre-Funded Warrant we sell, the number of shares of Common Stock we are offering will be decreased on a one-for-one basis. Each share
of Common Stock or Pre-Funded Warrant is being sold together with a Common Warrant to purchase one share of Common Stock. The shares of
Common Stock or Pre-Funded Warrants and accompanying Common Warrants will be issued separately. We are also registering the shares of
Common Stock issuable from time to time upon exercise of the Pre-Funded Warrants offered hereby and the Common Warrants offered hereby.
Common Stock. See the description above under “Description
of our Capital Stock- Common Stock.”
Common Warrants to be Issued in this Offering
The following summary of certain terms and provisions of the Common
Warrants included with the Common Stock that are being offered hereby is not complete and is subject to, and qualified in its entirety
by, the provisions of the Common Warrants, the form of which is filed as an exhibit to our registration statement of which this prospectus
forms a part.
Duration and Exercise Price
Each Common Warrant offered hereby will be a warrant to
purchase one share of Common Stock and will have an initial exercise price equal to $[·]
per share ([·]% of the assumed public offering price per share of Common Stock and
accompanying Common Warrant, which is based on the closing price of the Common Stock on the NYSE American on January 17, 2025
of $1.48). The Common Warrants will be exercisable immediately upon issuance and will expire five years from the date of issuance.
The exercise price and number of shares of Common Stock issuable upon exercise is subject to appropriate adjustment in the event of
share dividends, share splits, reorganizations or similar events affecting the Common Stock and the exercise price. Subject to the
rules and regulations of the applicable trading market, we may at any time during the term of the Common Warrant, subject to
the prior written consent of the holders, reduce the then current exercise price to any amount and for any period of time deemed
appropriate by our board of directors. The Common Warrants will be issued separately from the shares of Common Stock, or the
Pre-Funded Warrants, as the case may be.
Exercisability
The Common Warrants will be exercisable, at the option of each holder,
in whole or in part, by delivering to us a duly executed exercise notice accompanied by payment in full for the number of shares of Common
Stock purchased upon such exercise (except in the case of a cashless exercise as discussed below). A holder (together with its affiliates)
may not exercise any portion of the Common Warrant to the extent that the holder would own more than 4.99% of the outstanding shares
of our common warrant immediately after exercise, except that upon at least 61 days’ prior notice from the holder to us, the
holder may increase the amount of beneficial ownership of outstanding shares after exercising the holder’s Common Warrants up to
9.99% of the number of our shares of Common Stock outstanding immediately after giving effect to the exercise, as such percentage ownership
is determined in accordance with the terms of the Common Warrants. Purchasers of Common Warrants in this offering may also elect prior
to the issuance of the Common Warrants to have the initial exercise limitation set at 9.99% of our outstanding shares.
Cashless Exercise
If, at the time a holder exercises its Common Warrants, a registration
statement registering the issuance of the shares of Common Stock underlying the Common Warrants under the Securities Act is not then
effective or available for the issuance of such shares, then in lieu of making the cash payment otherwise contemplated to be made to
us upon such exercise in payment of the aggregate exercise price and subject to the nominal value of the shares being paid up as described
below, the holder may elect instead to receive upon such exercise (either in whole or in part) the net number of shares determined according
to a formula set forth in the Common Warrants.
Fractional Shares
No fractional shares of Common Stock or scrip representing fractional
shares will be issued upon the exercise of the Common Warrants. Rather, the number of shares of Common Stock to be issued will, at our
election, either be rounded up to the next whole share or we will pay a cash adjustment in respect of such final fraction in an amount
equal to such fraction multiplied by the exercise price.
Transferability
Subject to applicable laws, a Common Warrant may be transferred at
the option of the holder upon surrender of the Common Warrant to us together with the appropriate instruments of transfer and funds sufficient
to pay any transfer taxes payable upon such transfer.
Trading Market
There is no trading market available for the Common Warrants on any
securities exchange or nationally recognized trading system, and we do not expect a trading market to develop. We do not intend to list
the Common Warrants on any securities exchange or nationally recognized trading market. Without a trading market, the liquidity of the
Common Warrants will be extremely limited. The shares of Common Stock issuable upon exercise of the Common Warrants are currently traded
on the NYSE American.
Right as a Stockholder
Except as otherwise provided in the Common Warrants or by virtue of
such holder’s ownership of Common Stock, the holders of the Common Warrants do not have the rights or privileges of holders of
shares of Common Stock, including any voting rights, until they exercise their Common Warrants. The Common Warrants will provide that
holders have the right to participate in distributions or dividends paid on Common Stock.
Fundamental Transaction
In the event of a fundamental transaction, as described in the Common
Warrants and generally including (i) our merger or consolidation with or into another person, (ii) the sale, lease, license,
assignment, transfer, conveyance or other disposition of all or substantially all of our assets, (iii) any purchase offer, tender
offer or exchange offer pursuant to which holders of our Common Stock are permitted to sell, tender or exchange their shares for other
securities, cash or property and has been accepted by the holders of 50% or more of our outstanding Common Stock or 50% or more of the
voting power of our common equity, (iv) any reclassification, reorganization or recapitalization of our shares of Common Stock or
any compulsory share exchange or (v) any stock or share purchase agreement or other business combination with another person or
group of persons whereby such other person or group acquires 50% or more of our outstanding shares of Common Stock or 50% or more of
the voting power of our common equity, the holders will be entitled to receive the number of shares of the Common Stock for which the
Common Warrant is exercisable immediately prior to the occurrence of such fundamental transaction. Notwithstanding the foregoing, in
the event of a fundamental transaction, the holders of the Common Warrants have the right to require us or a successor entity to redeem
the Common Warrants for cash in the amount of the Black Scholes Value (as defined in each warrant) of the unexercised portion of the
Common Warrants concurrently with or within 30 days following the consummation of a fundamental transaction.
However, in the event of a fundamental transaction which is not in
our control, including a fundamental transaction not approved by our board of directors, the holders of the Common Warrants will only
be entitled to receive from us or our successor entity, as of the date of consummation of such fundamental transaction the same type
or form of consideration (and in the same proportion), at the Black Scholes Value of the unexercised portion of the Common Warrant that
is being offered and paid to the holders of the Common Stock in connection with the fundamental transaction, whether that consideration
is in the form of cash, stock or any combination of cash and stock, or whether the holders of the Common Stock are given the choice to
receive alternative forms of consideration in connection with the fundamental transaction.
Pre-Funded Warrants to be Issued in this Offering
The following summary of certain terms and provisions of the Pre-Funded
Warrants that are being offered hereby is not complete and is subject to, and qualified in its entirety by, the provisions of the Pre-Funded
Warrant, the form of which is filed as an exhibit to our registration statement of which this prospectus forms a part. Prospective investors
should carefully review the terms and provisions of the form of Pre-Funded Warrant for a complete description of the terms and conditions
of the Pre-Funded Warrants.
Duration and Exercise Price
Each Pre-Funded Warrant offered hereby will have an initial exercise
price per share equal to $0.001. The Pre-Funded Warrants will be immediately exercisable and will expire when exercised in full. The
exercise price and number of shares of Common Stock issuable upon exercise is subject to appropriate adjustment in the event of share
dividends, share splits, reorganizations or similar events affecting our shares of Common Stock and the exercise price. Subject to the
rules and regulations of the applicable trading market, we may at any time during the term of the Pre-Funded Warrant, subject to
the prior written consent of the holders, reduce the then current exercise price to any amount and for any period of time deemed appropriate
by our board of directors. The Pre-Funded Warrants will be issued separately from the common warrants.
Exercisability
The Pre-Funded Warrants will be exercisable, at the option of each
holder, in whole or in part, by delivering to us a duly executed exercise notice accompanied by payment in full for the number of shares
of Common Stock purchased upon such exercise (except in the case of a cashless exercise as discussed below). A holder (together with
its affiliates) may not exercise any portion of the Pre-Funded Warrant to the extent that the holder would own more than 4.99% of the
outstanding shares of the Common Stock immediately after exercise, except that upon at least 61 days’ prior notice from the
holder to us, the holder may increase the amount of beneficial ownership of outstanding shares after exercising the holder’s Pre-Funded
Warrants up to 9.99% of the number of our shares outstanding immediately after giving effect to the exercise, as such percentage ownership
is determined in accordance with the terms of the Pre-Funded Warrants. Purchasers of Pre-Funded Warrants in this offering may also elect
prior to the issuance of the Pre-Funded Warrants to have the initial exercise limitation set at 9.99% of our outstanding shares of Common
Stock.
Cashless Exercise
If, at the time a holder exercises its Pre-Funded Warrants, a registration
statement registering the issuance of the shares of Common Stock underlying the Pre-Funded Warrants under the Securities Act is not then
effective or available for the issuance of such shares, then in lieu of making the cash payment otherwise contemplated to be made to
us upon such exercise in payment of the aggregate exercise price, the holder may elect instead to receive upon such exercise (either
in whole or in part) the net number of shares of Common Stock determined according to a formula set forth in the Pre-Funded Warrants.
Fractional Shares
No fractional shares of Common Stock or scrip representing fractional
shares will be issued upon the exercise of the Pre-Funded Warrants. Rather, the number of shares of Common Stock to be issued will, at
our election, either be rounded up to the next whole share or we will pay a cash adjustment in respect of such final fraction in an amount
equal to such fraction multiplied by the exercise price.
Transferability
Subject to applicable laws, a Pre-Funded Warrant may be transferred
at the option of the holder upon surrender of the Pre-Funded Warrant to us together with the appropriate instruments of transfer and
funds sufficient to pay any transfer taxes payable upon such transfer.
Trading Market
There is no trading market available for the Pre-Funded Warrants on
any securities exchange or nationally recognized trading system, and we do not expect a trading market to develop. We do not intend to
list the Pre-Funded Warrants on any securities exchange or nationally recognized trading market. Without a trading market, the liquidity
of Pre-Funded Warrants will be extremely limited. The shares of Common Stock issuable upon exercise of the Pre-Funded Warrants are currently
traded on the NYSE American.
Right as a Stockholder
Except as otherwise provided in the Pre-Funded Warrants or by virtue
of such holder’s ownership of Common Stock, the holders of the Pre-Funded Warrants do not have the rights or privileges of holders
of the Common Stock, including any voting rights, until they exercise their Pre-Funded Warrants. The Pre-Funded Warrants will provide
that holders have the right to participate in distributions or dividends paid on Common Stock.
Fundamental Transaction
In the event of a fundamental transaction, as described in the Pre-Funded
Warrants and generally including (i) our merger or consolidation with or into another person, (ii) the sale, lease, license,
assignment, transfer, conveyance or other disposition of all or substantially all of our assets, (iii) any purchase offer, tender
offer or exchange offer pursuant to which holders of the Common Stock are permitted to sell, tender or exchange their shares for other
securities, cash or property and has been accepted by the holders of 50% or more of our outstanding Common Stock or 50% or more of the
voting power of our common equity, (iv) any reclassification, reorganization or recapitalization of our shares of Common Stock or
any compulsory share exchange or (v) any stock or share purchase agreement or other business combination with another person or
group of persons whereby such other person or group acquires 50% or more of our outstanding shares of Common Stock or 50% or more of
the voting power of our common equity, the holders of the Pre-Funded Warrants will be entitled to receive upon exercise of the Pre-Funded
Warrants the kind and amount of securities, cash or other property that the holders would have received had they exercised the Pre-Funded
Warrants immediately prior to such fundamental transaction.
MATERIAL
UNITED STATES FEDERAL INCOME TAX CONSIDERATIONS
The following discussion describes the material U.S. federal income
tax consequences of the acquisition, ownership and disposition of the Common Stock, Pre-Funded Warrants and Common Warrants acquired
in this Offering. This discussion is based on the current provisions of the Internal Revenue Code of 1986, as amended, referred to as
the Code, existing and proposed U.S. Treasury regulations promulgated thereunder, and administrative rulings and court decisions in effect
as of the date hereof, all of which are subject to change at any time, possibly with retroactive effect. No ruling has been or will be
sought from the Internal Revenue Service, or IRS, with respect to the matters discussed below, and there can be no assurance the IRS
will not take a contrary position regarding the tax consequences of the acquisition, ownership or disposition of the Common Stock, Pre-Funded
Warrants or Common Warrants, or that any such contrary position would not be sustained by a court.
We assume in this discussion that the shares of Common Stock, Pre-Funded
Warrants and Common Warrants will be held as capital assets (generally, property held for investment). This discussion does not address
all aspects of U.S. federal income taxes, does not discuss the potential application of the Medicare contribution tax or the alternative
minimum tax and does not address state or local taxes or U.S. federal gift and estate tax laws, except as specifically provided below
with respect to non-U.S. holders, or any non-U.S. tax consequences that may be relevant to holders in light of their particular circumstances.
This discussion also does not address the special tax rules applicable to particular holders, such as:
| · | persons
who acquired the Common Stock, Pre-Funded Warrants or Common Warrants s as compensation for
services; |
| · | traders
in securities that elect to use a mark-to-market method of accounting for their securities
holdings; |
| · | persons
that own, or are deemed to own, more than 5% of the Common Stock (except to the extent specifically
set forth below); |
| · | persons
required for U.S. federal income tax purposes to conform the timing of income accruals to
their financial statements under Section 451(b) of the Code (except to the extent
specifically set forth below); |
| · | persons
for whom the Common Stock constitutes “qualified small business stock” within
the meaning of Section 1202 of the Code or “Section 1244 stock” for
purposes of Section 1244 of the Code; |
| · | persons
deemed sell the Common Stock, Pre-Funded Warrants or Common Warrants under the constructive
sale provisions of the Code; |
| · | banks
or other financial institutions; |
| · | brokers
or dealers in securities or currencies; |
| · | tax-exempt
organizations or tax-qualified retirement plans; |
| · | regulated
investment companies or real estate investment trusts; |
| · | persons
that hold the Common Stock, Pre-Funded Warrants or Common Warrants as part of a straddle,
hedge, conversion transaction, synthetic security or other integrated investment; |
| · | controlled
foreign corporations, passive foreign investment companies, or corporations that accumulate
earnings to avoid U.S. federal income tax; and |
| · | certain
U.S. expatriates, former citizens, or long-term residents of the United States. |
In addition, this discussion does not address the tax treatment of
partnerships (including any entity or arrangement classified as a partnership for U.S. federal income tax purposes) or other pass-through
entities or persons who hold shares of Common Stock, Pre-Funded Warrants or Common Warrants through such partnerships or other entities
which are pass-through entities for U.S. federal income tax purposes. If such a partnership or other pass-through entity holds shares
of Common Stock, Pre-Funded Warrants or Common Warrants, the treatment of a partner in such partnership or investor in such other pass-through
entity generally will depend on the status of the partner or investor and upon the activities of the partnership or other pass-through
entity. A partner in such a partnership and an investor in such other pass-through entity that will hold shares of Common Stock, Pre-Funded
Warrants or Common Warrants should consult his, her or its own tax advisor regarding the tax consequences of the ownership and disposition
of shares of Common Stock, Pre-Funded Warrants or Common Warrants through such partnership or other pass-through entity, as applicable.
This discussion of U.S. federal income tax considerations is for
general information purposes only and is not tax advice. Prospective investors should consult their own tax advisors regarding the U.S.
federal, state, local and non-U.S. income and other tax considerations of acquiring, holding and disposing of the Common Stock, Pre-Funded
Warrants and Common Warrants.
For the purposes of this discussion, a “U.S. Holder” means
a beneficial owner of shares of Common Stock, Pre-Funded Warrants or Common Warrants that is for U.S. federal income tax purposes (a) an
individual citizen or resident of the United States, (b) a corporation (or other entity taxable as a corporation for U.S. federal
income tax purposes), created or organized in or under the laws of the United States, any state thereof or the District of Columbia,
(c) an estate the income of which is subject to U.S. federal income taxation regardless of its source, or (d) a trust if it
(1) is subject to the primary supervision of a court within the United States and one or more U.S. persons (within the meaning of
Section 7701(a)(30) of the Code) has the authority to control all substantial decisions of the trust or (2) has a valid election
in effect under applicable U.S. Treasury regulations to be treated as a domestic trust. A “Non-U.S. Holder” is, for U.S.
federal income tax purposes, a beneficial owner of shares of Common Stock, Pre-Funded Warrants or Common Warrants that is not a U.S.
Holder or a partnership for U.S. federal income tax purposes.
Potential Acceleration of Income
Under tax legislation signed into law in December 2017 commonly
known as the Tax Cuts and Jobs Act of 2017, U.S. Holders that use an accrual method of accounting for tax purposes and have certain financial
statements generally will be required to include certain amounts in income no later than the time such amounts are taken into account
as revenue in such financial statements.
In addition, under the Inflation Reduction Act signed into law on
August 16, 2022, certain large corporations (generally, corporations reporting at least $1 billion average adjusted pre-tax net
income on their consolidated financial statements) are potentially subject to a 15% alternative minimum tax on the “adjusted financial
statement income” of such large corporations for tax years beginning after December 31, 2022. The U.S. Treasury Department,
the IRS, and other standard-setting bodies are expected to issue guidance on how the alternative minimum tax provisions of the Inflation
Reduction Act will be applied or otherwise administered.
The application of these rules thus may require the accrual of
income earlier than would be the case under the general tax rules described below, although the precise application of these rules is
unclear at this time. U.S. Holders that use an accrual method of accounting should consult with their tax advisors regarding the potential
applicability of this legislation to their particular situation.
Treatment of Pre-Funded Warrants
Although it is not entirely free from doubt, a pre-funded warrant
should be treated as a share of Common Stock for U.S. federal income tax purposes and a holder of Pre-Funded Warrants should generally
be taxed in the same manner as a holder of Common Stock, as described below. Accordingly, no gain or loss should be recognized upon the
exercise of a Pre-Funded Warrant and, upon exercise, the holding period of a Pre-Funded Warrant should carry over to the share of Common
Stock received. Similarly, the tax basis of the Pre-Funded Warrant should carry over to the share of Common Stock received upon exercise,
increased by the exercise price of $0.001 per share. Each holder should consult his, her or its own tax advisor regarding the risks associated
with the acquisition of Pre-Funded Warrants pursuant to this Offering (including potential alternative characterizations). The balance
of this discussion generally assumes that the characterization described above is respected for U.S. federal income tax purposes.
Allocation of Purchase Price
For U.S. federal income tax purposes, each share of Common Stock (or,
in lieu of Common Stock, each Pre-Funded Warrant t) and the accompanying Common Warrants issued pursuant to this offering will be treated
as an “investment unit” each of which consisting of one share of Common Stock or one Pre-Funded Warrant (which, as described
above, should generally be treated as a share of Common Stock for U.S. federal income tax purposes), as applicable and the accompanying
Common Warrant to acquire one share of Common Stock. The purchase price for each investment unit will be allocated between these components
in proportion to their relative fair market values at the time the unit is purchased by the holder. This allocation of the purchase price
for each unit will establish the holder’s initial tax basis for U.S. federal income tax purposes in the share of Common Stock (or,
in lieu of Common Stock, Pre-Funded Warrant) and the common warrant included in each unit. The separation of the share of Common Stock
(or, in lieu of Common Stock, Pre-Funded Warrant) and the Common Warrant included in a unit should not be a taxable event for U.S. federal
income tax purposes. Each holder should consult his, her or its own tax advisor regarding the allocation of the purchase price between
the Common Stock (or, in lieu of Common Stock, Pre-Funded Warrants) and the Common Warrants..
Tax Considerations Applicable to U.S. Holders
Exercise and Expiration of Common Warrants
Except as discussed below with respect to the cashless exercise of
a Common Warrant, a U.S. Holder generally will not recognize gain or loss for U.S. federal income tax purposes upon exercise of a Common
Warrant. The U.S. Holder will take a tax basis in the shares acquired on the exercise of a Common Warrant equal to the exercise price
of the Common Warrant, increased by the U.S. Holder’s adjusted tax basis in the Common Warrant exercised (as determined pursuant
to the rules discussed above). The U.S. Holder’s holding period in the shares of Common Stock acquired on the exercise of
a Common Warrant will begin on the date of exercise or possibly the day after such exercise, and will not include any period for which
the U.S. Holder held the Common Warrant.
The lapse or expiration of a Common Warrant will be treated as if
the U.S. Holder sold or exchanged the Common Warrant and recognized a capital loss equal to the U.S. Holder’s tax basis in the
Common Warrant. The deductibility of capital losses is subject to limitations.
The tax consequences of a cashless exercise of a Common Warrant are
not clear under current tax law. A cashless exercise may be tax-free, either because the exercise is not a realization event or because
the exercise is treated as a recapitalization for U.S. federal income tax purposes. In either tax-free situation, a U.S. Holder’s
tax basis in the Common Stock received generally would equal the U.S. Holder’s tax basis in the Common Warrants. If the cashless
exercise was not a realization event, it is unclear whether a U.S. Holder’s holding period for the Common Stock would be treated
as commencing on the date of exercise of the Common Warrant or the day following the date of exercise of the Common Warrant. If the cashless
exercise were treated as a recapitalization, the holding period of the Common Stock would include the holding period of the Common Warrants.
It is also possible that a cashless exercise could be treated as a
taxable exchange in which gain or loss would be recognized. In such event, a U.S. Holder could be deemed to have surrendered Common Warrants
having an aggregate fair market value equal to the exercise price for the total number of Common Warrants to be exercised. The U.S. Holder
would recognize capital gain or loss in an amount equal to the difference between the fair market value of the Common Stock received
in respect of the Common Warrants deemed surrendered and the U.S. Holder’s tax basis in such Common Warrants. Such gain or loss
would be long-term or short-term, depending on the U.S. Holder’s holding period in the Common Warrants deemed surrendered. In this
case, a U.S. Holder’s tax basis in the Common Stock received would equal the sum of the U.S. Holder’s initial investment
in the exercised Common Warrants (i.e., the portion of the U.S. Holder’s purchase price for the investment unit that is allocated
to the common warrants, as described above under “Allocation of Purchase Price”) and the exercise price of such Common Warrants.
It is unclear whether a U.S. Holder’s holding period for the Common Stock would commence on the date of exercise of the Common
Warrant or the day following the date of exercise of the Common Warrant. There may also be alternative characterizations of any such
taxable exchange that would result in similar tax consequences, except that a U.S. Holder’s gain or loss would be short-term. Due
to the absence of authority on the U.S. federal income tax treatment of a cashless exercise, there can be no assurance which, if any,
of the alternative tax consequences and holding periods described above would be adopted by the IRS or a court of law. Accordingly, U.S.
Holders should consult their tax advisors regarding the tax consequences of a cashless exercise of the Common Warrants.
Distributions
As discussed above, we currently anticipate that we will retain future
earnings, if any, to finance the growth and development of our business and do not intend to pay cash dividends in respect of shares
of Common Stock in the foreseeable future. In the event that we do make distributions on the Common Stock to a U.S. Holder, those distributions
generally will constitute dividends for U.S. tax purposes to the extent paid out of our current or accumulated earnings and profits (as
determined under U.S. federal income tax principles). Distributions in excess of our current and accumulated earnings and profits will
constitute a return of capital that is applied against and reduces, but not below zero, a U.S. Holder’s adjusted tax basis in the
Common Stock. Any remaining excess will be treated as gain realized on the sale or exchange of shares of Common Stock as described below
under the section titled “—Disposition of Common Stock, Pre-Funded Warrants or Common Warrants.”
Certain Adjustments to Pre-Funded Warrants or Common Warrants
The number of shares of Common Stock issued upon the exercise of the
Pre-Funded Warrants or Common Warrants and the exercise price of Pre-Funded Warrants or Common Warrants are subject to adjustment in
certain circumstances. Adjustments (or failure to make adjustments) that have the effect of increasing a U.S. Holder’s proportionate
interest in our assets or earnings and profits may, in some circumstances, result in a constructive distribution to the U.S. Holder.
Adjustments to the conversion rate made pursuant to a bona fide reasonable adjustment formula which has the effect of preventing the
dilution of the interest of the holders of Pre-Funded Warrants or Common Warrants generally should not be deemed to result in a constructive
distribution. If an adjustment is made that does not qualify as being made pursuant to a bona fide reasonable adjustment formula, a U.S.
Holder of Pre-Funded Warrants or Common Warrants may be deemed to have received a constructive distribution from us, even though such
U.S. Holder has not received any cash or property as a result of such adjustment. The tax consequences of the receipt of a distribution
from us are described above under “Distributions.”
Disposition of Common Stock, Pre-Funded Warrants or Common Warrants
Upon a sale or other taxable disposition (other than a redemption
treated as a distribution, which will be taxed as described above under “Distributions”) of shares of Common Stock, Pre-Funded
Warrants or Common Warrants, a U.S. Holder generally will recognize capital gain or loss in an amount equal to the difference between
the amount realized and the U.S. Holder’s adjusted tax basis in the Common Stock, Pre-Funded Warrants or Common Warrants sold.
Capital gain or loss will constitute long-term capital gain or loss if the U.S. Holder’s holding period for the Common Stock, Pre-Funded
Warrants or Common Warrants exceeds one year. The deductibility of capital losses is subject to certain limitations. U.S. Holders who
recognize losses with respect to a disposition of shares of Common Stock, Pre-Funded Warrants or Common Warrants should consult their
own tax advisors regarding the tax treatment of such losses.
Information Reporting and Backup Reporting
Information reporting requirements generally will apply to payments
of distributions (including constructive distributions) on the Common Stock, Pre-Funded Warrants and Common Warrants and to the proceeds
of a sale or other disposition of Common Stock, Pre-Funded Warrants and Common Warrants paid by us to a U.S. Holder unless such U.S.
Holder is an exempt recipient, such as a corporation. Backup withholding will apply to those payments if the U.S. Holder fails to provide
the holder’s taxpayer identification number, or certification of exempt status, or if the holder otherwise fails to comply with
applicable requirements to establish an exemption.
Backup withholding is not an additional tax. Rather, any amounts withheld
under the backup withholding rules will be allowed as a refund or a credit against the U.S. Holder’s U.S. federal income tax
liability provided the required information is timely furnished to the IRS. U.S. Holders should consult their own tax advisors regarding
their qualification for exemption from information reporting and backup withholding and the procedure for obtaining such exemption.
Tax Considerations Applicable to Non-U.S. Holders
Exercise and Expiration of Common Warrants
In general, a Non-U.S. Holder will not recognize gain or loss for
U.S. federal income tax purposes upon the exercise of Common Warrants into shares of Common Stock, however, to the extent a cashless
exercise results in a taxable exchange, the consequences would be similar to those described in the discussion below under “Disposition
of Common Stock, Pre-Funded Warrants or Common Warrants.”
The expiration of a Common Warrant will be treated as if the Non-U.S.
Holder sold or exchanged Common Warrant and recognized a capital loss equal to the Non-U.S. Holder’s tax basis in the common warrants.
However, a Non-U.S. Holder will not be able to utilize a loss recognized upon expiration of a Common Warrant against the Non-U.S. Holder’s
U.S. federal income tax liability unless the loss is effectively connected with the Non-U.S. Holder’s conduct of a trade or business
within the United States (and, if an income tax treaty applies, is attributable to a permanent establishment or fixed base in the United
States) or is treated as a U.S.-source loss and the Non-U.S. Holder is present 183 days or more in the taxable year of disposition and
certain other conditions are met.
Certain Adjustments to Warrants
As described under “—U.S. Holders—Certain Adjustments
to Pre-Funded Warrants or Common Warrants,” an adjustment to the Pre-Funded Warrants or Common Warrants could result in a constructive
distribution to a Non-U.S. Holder, which would be treated as described under “Distributions” below. Any resulting withholding
tax attributable to deemed dividends would be collected from other amounts payable or distributable to the Non-U.S. Holder. Non-U.S.
Holders should consult their tax advisors regarding the proper treatment of any adjustments to the Pre-Funded Warrants or Common Warrants.
In addition, regulations governing “dividend equivalents”
under Section 871(m) of the Code may apply to the Pre-Funded Warrants. Under those regulations, an implicit or explicit payment
under Pre-Funded Warrants that references a dividend distribution on the Common Stock would possibly be taxable to a Non-U.S. Holder
as described under “Distributions” below. Such dividend equivalent amount would be taxable and subject to withholding whether
or not there is actual payment of cash or other property, and the Company may satisfy any withholding obligations it has in respect of
the Pre-Funded Warrants by withholding from other amounts due to the Non-U.S. Holder. Non-U.S. Holders are encouraged to consult their
own tax advisors regarding the application of Section 871(m) of the Code to the Pre-Funded Warrants.
Distributions
As discussed above, we currently anticipate that we will retain future
earnings, if any, to finance the growth and development of our business and do not intend to pay cash dividends in respect of the Common
Stock in the foreseeable future. In the event that we do make distributions on the Common Stock to a Non-U.S. Holder, those distributions
generally will constitute dividends for U.S. federal income tax purposes as described in “—U.S. Holders—Distributions.”
To the extent those distributions do not constitute dividends for U.S. federal income tax purposes (i.e., the amount of such distributions
exceeds both our current and our accumulated earnings and profits), they will constitute a return of capital and will first reduce a
Non-U.S. Holder's basis in the Common Stock (determined separately with respect to each share of Common Stock), but not below zero, and
then will be treated as gain from the sale of that share Common Stock as described below under the section titled “—Disposition
of Common Stock, Pre-Funded Warrants or Common Warrants.”
Any distribution (including constructive distributions) on shares
of Common Stock that is treated as a dividend paid to a Non-U.S. Holder that is not effectively connected with the holder’s conduct
of a trade or business in the United States will generally be subject to withholding tax at a 30% rate or such lower rate as may be specified
by an applicable income tax treaty between the United States and the Non-U.S. Holder’s country of residence. To obtain a reduced
rate of withholding under a treaty, a Non-U.S. Holder generally will be required to provide the applicable withholding agent with a properly
executed IRS Form W-8BEN, IRS Form W-8BEN-E or other appropriate form, certifying the Non-U.S. Holder’s entitlement
to benefits under that treaty. Such form must be provided prior to the payment of dividends and must be updated periodically. If a Non-U.S.
Holder holds stock through a financial institution or other agent acting on the holder’s behalf, the holder will be required to
provide appropriate documentation to such agent. The holder’s agent may then be required to provide certification to the applicable
withholding agent, either directly or through other intermediaries. If you are eligible for a reduced rate of U.S. withholding tax under
an income tax treaty, you should consult with your own tax advisor to determine if you are able to obtain a refund or credit of any excess
amounts withheld by timely filing an appropriate claim for a refund with the IRS.
We generally are not required to withhold tax on dividends paid (or
constructive dividends deemed paid) to a Non-U.S. Holder that are effectively connected with the holder’s conduct of a trade or
business within the United States (and, if required by an applicable income tax treaty, are attributable to a permanent establishment
or fixed base that the holder maintains in the United States) if a properly executed IRS Form W-8ECI, stating that the dividends
are so connected, is furnished to us (or, if stock is held through a financial institution or other agent, to the applicable withholding
agent). In general, such effectively connected dividends will be subject to U.S. federal income tax on a net income basis at the regular
tax rates applicable to U.S. persons. A corporate Non-U.S. Holder receiving effectively connected dividends may also be subject to an
additional “branch profits tax,” which is imposed, under certain circumstances, at a rate of 30% (or such lower rate as may
be specified by an applicable treaty) on the corporate Non-U.S. Holder’s effectively connected earnings and profits, subject to
certain adjustments.
See also the sections below titled “—Backup Withholding
and Information Reporting” and “—Foreign Accounts” for additional withholding rules that may apply to dividends
paid to certain foreign financial institutions or non-financial foreign entities.
Disposition of Common Stock, Pre-Funded Warrants or Common Warrants
Subject to the discussions below under the sections titled “—Backup
Withholding and Information Reporting” and “—Foreign Accounts,” a Non-U.S. Holder generally will not be subject
to U.S. federal income or withholding tax with respect to gain recognized on a sale or other disposition (other than a redemption treated
as a distribution, which will be taxable as described above under “Distributions”) of shares of Common Stock, Pre-Funded
Warrants or Common Warrants unless:
| · | the
gain is effectively connected with the Non-U.S. Holder’s conduct of a trade or business
in the United States, and if an applicable income tax treaty so provides, the gain is attributable
to a permanent establishment or fixed base maintained by the Non-U.S. Holder in the United
States; in these cases, the Non-U.S. Holder will be taxed on a net income basis at the regular
tax rates and in the manner applicable to U.S. persons, and if the Non-U.S. Holder is a corporation,
an additional branch profits tax at a rate of 30%, or a lower rate as may be specified by
an applicable income tax treaty, may also apply; |
| · | the
Non-U.S. Holder is a nonresident alien present in the United States for 183 days or more
in the taxable year of the disposition and certain other requirements are met, in which case
the Non-U.S. Holder will be subject to a 30% tax (or such lower rate as may be specified
by an applicable income tax treaty between the United States and such holder’s country
of residence) on the net gain derived from the disposition, which may be offset by certain
U.S.-source capital losses of the Non-U.S. Holder, if any; or |
| · | the
Common Stock constitutes a U.S. real property interest because we are, or have been at any
time during the five-year period preceding such disposition (or the Non-U.S. Holder’s
holding period of the Common Stock, Pre-Funded Warrants or Common Warrants, if shorter),
a “U.S. real property holding corporation,” unless the Common Stock is regularly
traded on an established securities market, as defined by applicable Treasury Regulations,
and the Non-U.S. Holder held no more than 5% of our outstanding Common Stock, directly or
indirectly, during the shorter of the five-year period ending on the date of the disposition
or the period that the Non-U.S. Holder held the Common Stock. Special rules may apply
to the determination of the 5% threshold in the case of a holder of Pre-Funded Warrants or
Common Warrants. Non-U.S. Holders are urged to consult their own tax advisors regarding the
effect of holding Pre-Funded Warrants or Common Warrants on the calculation of such 5% threshold.
Generally, a corporation is a “U.S. real property holding corporation” if the
fair market value of its “U.S. real property interests” (as defined in the Code
and applicable regulations) equals or exceeds 50% of the sum of the fair market value of
its worldwide real property interests plus its other assets used or held for use in a trade
or business. Although there can be no assurance, we believe that we are not currently, and
we do not anticipate becoming, a “U.S. real property holding corporation” for
U.S. federal income tax purposes. No assurance can be provided that the Common Stock will
be regularly traded on an established securities market for purposes of the rules described
above. Non-U.S. Holders are urged to consult their own tax advisors regarding the U.S. federal
income tax considerations that could result if we are, or become a “U.S. real property
holding corporation.” |
See the sections titled “—Backup Withholding and Information
Reporting” and “—Foreign Accounts” for additional information regarding withholding rules that may apply
to proceeds of a disposition of the Common Stock, Pre-Funded Warrants or Common Warrants paid to foreign financial institutions or non-financial
foreign entities.
Backup Withholding and Information Reporting
We must report annually to the IRS and to each Non-U.S. Holder the
gross amount of the distributions (including constructive distributions) on the Common Stock, pre-funded warrants or common warrants
paid to such holder and the tax withheld, if any, with respect to such distributions. Non-U.S. Holders may have to comply with specific
certification procedures to establish that the holder is not a U.S. person (as defined in the Code) in order to avoid backup withholding
at the applicable rate, currently 24%, with respect to dividends (or constructive dividends) on the Common Stock, Pre-Funded Warrants
or Common Warrants. Generally, a holder will comply with such procedures if it provides a properly executed IRS Form W-8BEN (or
other applicable Form W-8) or otherwise meets documentary evidence requirements for establishing that it is a Non-U.S. Holder, or
otherwise establishes an exemption. Dividends paid to Non-U.S. Holders subject to withholding of U.S. federal income tax, as described
above under the heading “Distributions,” will generally be exempt from U.S. backup withholding.
Information reporting and backup withholding generally will apply
to the proceeds of a disposition of the Common Stock, pre-funded warrants or common warrants by a Non-U.S. Holder effected by or through
the U.S. office of any broker, U.S. or foreign, unless the holder certifies its status as a Non-U.S. Holder and satisfies certain other
requirements, or otherwise establishes an exemption. Generally, information reporting and backup withholding will not apply to a payment
of disposition proceeds to a Non-U.S. Holder where the transaction is effected outside the United States through a non-U.S. office of
a broker. However, for information reporting purposes, dispositions effected through a non-U.S. office of a broker with substantial U.S.
ownership or operations generally will be treated in a manner similar to dispositions effected through a U.S. office of a broker. Non-U.S.
Holders should consult their own tax advisors regarding the application of the information reporting and backup withholding rules to
them.
Copies of information returns may be made available to the tax authorities
of the country in which the Non-U.S. Holder resides or is incorporated under the provisions of a specific treaty or agreement.
Backup withholding is not an additional tax. Any amounts withheld
under the backup withholding rules from a payment to a Non-U.S. Holder can be refunded or credited against the Non-U.S. Holder’s
U.S. federal income tax liability, if any, provided that an appropriate claim is timely filed with the IRS.
Foreign Accounts
The Foreign Account Tax Compliance Act, or FATCA, generally imposes
a 30% withholding tax on dividends (including constructive dividends) on the Common Stock, pre-funded warrants and common warrants if
paid to a non-U.S. entity unless (i) if the non-U.S. entity is a “foreign financial institution,” the non-U.S. entity
undertakes certain due diligence, reporting, withholding, and certification obligations, (ii) if the non-U.S. entity is not a “foreign
financial institution,” the non-U.S. entity identifies certain of its U.S. investors, if any, or (iii) the non-U.S. entity
is otherwise exempt under FATCA.
Withholding under FATCA generally will apply to payments of dividends
(including constructive dividends) on the Common Stock, Pre-Funded Warrants and Common Warrants. While withholding under FATCA would
have also applied to payments of gross proceeds from a sale or other disposition of the Common Stock, pre-funded warrants or common warrants,
under proposed U.S. Treasury Regulations withholding on payments of gross proceeds is not required. Although such regulations are not
final, applicable withholding agents may rely on the proposed regulations until final regulations are issued.
An intergovernmental agreement between the United States and an applicable
foreign country may modify the requirements described in this section. Under certain circumstances, a holder may be eligible for refunds
or credits of the tax. Holders should consult their own tax advisors regarding the possible implications of FATCA on their investment
in the Common Stock, Pre-Funded Warrants or Common Warrants.
Federal Estate Tax
Common Stock owned or treated as owned by an individual who is not
a citizen or resident of the United States (as specially defined for U.S. federal estate tax purposes) at the time of death will be included
in the individual’s gross estate for U.S. federal estate tax purposes and, therefore, may be subject to U.S. federal estate tax,
unless an applicable estate tax or other treaty provides otherwise. The foregoing may also apply to common warrants and pre-funded warrants.
A Non-U.S. Holder should consult his, her, or its own tax advisor regarding the U.S. federal estate tax consequences of the ownership
or disposition of shares of the Common Stock, Pre-Funded Warrants and Common Warrants.
The preceding discussion of material U.S. federal tax considerations
is for information only. It is not tax advice. Prospective investors should consult their own tax advisors regarding the particular U.S.
federal, state, local and non-U.S. tax consequences of purchasing, holding and disposing of the Common Stock, Pre-Funded Warrants or
Common Warrants, including the consequences of any proposed changes in applicable laws.
Plan
of Distribution
A.G.P./Alliance Global Partners has agreed to act as our sole Placement
Agent in connection with this offering subject to the terms and conditions of the placement agency agreement dated [·],
2025. The Placement Agent is not purchasing or selling any of the securities offered by this prospectus, nor is it required to arrange
for the purchase and sale of any specific number or dollar amount of such securities, other than to use its reasonable “best efforts”
to arrange for the sale of such securities by us. Therefore, we may not sell all of the securities being offered pursuant to this prospectus.
The securities will be offered at a fixed price and are expected to be issued in a single closing. We will enter into a securities purchase
agreement directly with certain investors, at the investor’s option, who purchase our securities in this offering. Investors who
do not enter into a securities purchase agreement shall rely solely on this prospectus in connection with the purchase of our securities
in this offering.
We will deliver the securities being issued to the investors upon
receipt of investor funds for the purchase of the securities offered pursuant to this prospectus. We expect to deliver the securities
being offered pursuant to this prospectus on or about ,
2025.
Fees and Expenses
We have agreed to pay the Placement Agent an aggregate fee equal to
7.0% of the purchase price paid by all purchasers in this offering. In addition, we have agreed to reimburse the Placement Agent for
its legal fees in an amount up to $85,000 and non-accountable expenses of up to $15,000.
We estimate the total expenses of this offering paid or payable
by us, exclusive of the placement agent fee and reimbursements, will be approximately $250,000. After deducting the fees due to the Placement
Agent and our estimated expenses in connection with this offering, we expect the net proceeds from this offering will be approximately
$8.95 million (based on an assumed combined public offering price per share of Common Stock and accompanying Common Warrant of $1.48,
which was the last reported sales price of the Common Stock on the NYSE American on January 17, 2025).
The following table shows the per share and total cash fees we will
pay to the Placement Agent in connection with the sale of the securities pursuant to this prospectus.
| |
Per
Share of
Common Stock
and
Accompanying
Common
Warrant | |
Per Pre-Funded
Warrant and Accompanying Common Warrant | |
Total |
Public offering price(1) | |
$ | |
$ | |
$ |
Placement agent fees | |
$ | |
$ | |
$ |
Proceeds before expenses to us(2) | |
$ | |
$ | |
$ |
|
(1) |
The assumed combined public offering price is $1.48 per share of Common
Stock and accompanying Common Warrant and $1.479 per Pre-Funded Warrant and accompanying Common Warrant. |
| (2) | Does not include proceeds from the exercise of the Pre-Funded Warrants
or Common Warrants in cash, if any. |
Indemnification
We have agreed to indemnify the Placement Agent and specified other
persons against specified liabilities, including liabilities under the Securities Act, and to contribute to payments the Placement Agent
may be required to make in respect thereof.
Lock-Up Agreements
Our directors and officers have entered into lock-up agreements. Under
these agreements, these individuals agreed, subject to specified exceptions, not to sell or transfer any shares of Common Stock or securities
convertible into, or exchangeable or exercisable for, Common Stock during a period ending 90 days after the completion of this offering,
without first obtaining the written consent of the Placement Agent. Specifically, these individuals agreed, in part, subject to certain
exceptions, not to:
| · | offer
for sale, sell, pledge, or otherwise transfer or dispose of (or enter into any transaction
or device that is designed to, or could be expected to, result in the transfer or disposition
by any person at any time in the future of) any shares of Common Stock or securities convertible
into or exercisable or exchangeable for Common Stock; |
| · | enter
into any swap or other derivatives transaction that transfers to another, in whole or in
part, any of the economic benefits or risks of ownership of shares of Common Stock; or |
| · | make
any demand for or exercise any right or cause to be filed a registration statement, including
any amendments thereto, with respect to the registration of any of our securities. |
No Sales of Similar Securities
We have agreed, subject to certain exceptions, not to issue, enter
into any agreement to issue or announce the issuance or proposed issuance of, any shares of Common Stock (or securities convertible into
or exercisable for Common Stock) or, subject to certain exceptions, file any registration statement, including any amendments or supplements
thereto (other than the registration statement or amendment to the registration statement relating to the securities offered hereunder
and a registration statement on Form S-8), until 60 days after the completion of this offering. We have also agreed not to enter
into or issue any shares under a variable rate transaction (as defined in the securities purchase agreement) for six months after the
completion of this offering, except that after the forty-five (45) day anniversary of the closing of this offering we may offer shares
of Common Stock pursuant to the ATM Sales Agreement between the Company and the Placement Agent, provided that after the fifteen (15) day anniversary of the closing
of this offering we may file a prospectus supplement with respect to sales under the Sales Agreement.
Regulation M
The Placement Agent may be deemed to be an underwriter within the
meaning of Section 2(a)(11) of the Securities Act, and any commissions received by it and any profit realized on the resale of the
shares sold by it while acting as principal might be deemed to be underwriting discounts or commissions under the Securities Act. As
an underwriter, the Placement Agent would be required to comply with the requirements of the Securities Act and the Exchange Act, including,
without limitation, Rule 415(a)(4) under the Securities Act and Rule 10b-5 and Regulation M under the Exchange Act. These
rules and regulations may limit the timing of purchases and sales of shares by the Placement Agent acting as principal. Under these
rules and regulations, the placement agents:
| · | may
not engage in any stabilization activity in connection with our securities; and |
| · | may
not bid for or purchase any of our securities or attempt to induce any person to purchase
any of our securities, other than as permitted under the Exchange Act, until it has completed
its participation in the distribution. |
Discretionary Accounts
The Placement Agent does not intend to confirm sales of the securities
offered hereby to any accounts over which it has discretionary authority.
Other Activities and Relationships
The Placement Agent and certain of its affiliates are full service
financial institutions engaged in various activities, which may include securities trading, commercial and investment banking, financial
advisory, investment management, investment research, principal investment, hedging, financing and brokerage activities. The Placement
Agent and certain of its affiliates have, from time to time, performed, and may in the future perform, various commercial and investment
banking and financial advisory services for us and our affiliates, for which they received or will receive customary fees and expenses.
For example, A.G.P./Alliance Global Partners was the placement agent for our public offering that was consummated on September 27, 2024
and received a fee of 7% of the gross proceeds of such offering plus an expense reimbursement of $100,000 and is the sales agent under
the ATM Sales Agreement. Under the ATM Sales Agreement, we may offer and sell, from time to time, shares of Common Stock through A.G.P./Alliance
Global Partners in an “at the market offering” as defined in Rule 415(a)(4) under the Securities Act.
In the ordinary course of its various business activities, the Placement
Agent and certain of its affiliates may make or hold a broad array of investments and actively trade debt and equity securities (or related
derivative securities) and financial instruments (including bank loans) for its own account and for the accounts of its customers, and
such investment and securities activities may involve securities and/or instruments issued by us and our affiliates. If the Placement
Agent or its affiliates have a lending relationship with us, they routinely hedge their credit exposure to us consistent with their customary
risk management policies. The Placement Agent and its affiliates may hedge such exposure by entering into transactions that consist of
either the purchase of credit default swaps or the creation of short positions in our securities or the securities of our affiliates,
including potentially the Common Stock offered hereby. Any such short positions could adversely affect future trading prices of the Common
Stock offered hereby. The Placement Agent and certain of its affiliates may also communicate independent investment recommendations,
market color or trading ideas and/or publish or express independent research views in respect of such securities or instruments and may
at any time hold, or recommend to clients that they acquire, long and/or short positions in such securities and instruments.
SECURITY
OWNERSHIP OF CERTAIN BENEFICIAL OWNERS AND MANAGEMENT
The following table sets forth information, as of January 17,
2025, or as otherwise set forth below, with respect to the beneficial ownership of our Common Stock (i) all persons known to us to be
the beneficial owners of more than 5% of the outstanding shares of our Common Stock; (ii) each of our directors and our named executive
officers named in the Summary Compensation Table; and (iii) all of our directors and our current executive officer as a group. All share
numbers set forth below reflect the 1-for-25 reverse stock split effected on August 26, 2024.
|
|
Shares Owned (2) |
|
|
|
Number of |
|
|
|
|
|
|
Shares |
|
|
Percentages |
|
Name and Address of Beneficial Ownership (1) |
|
Owned |
|
|
of Shares (3) |
|
Named Executive Officers and Directors |
|
|
|
|
|
|
|
|
Jeffrey J. Kraws (4) |
|
|
11,144 |
|
|
|
* |
|
Steven Shallcross (5) |
|
|
45,893 |
|
|
|
1.63 |
% |
Jeffrey Wolf (6) |
|
|
11,118 |
|
|
|
* |
|
John Monahan (7) |
|
|
9,900 |
|
|
|
* |
|
All current officers and directors as a group (4 persons) |
|
|
78,055 |
|
|
|
2.74 |
% |
|
|
|
|
|
|
|
|
|
5% Stockholders |
|
|
|
|
|
|
|
|
Armistice Capital Master Fund Ltd. (8) |
|
|
225,000 |
|
|
|
8.09 |
% |
CVI Investments, Inc. (9) |
|
|
180,000 |
|
|
|
6.47 |
% |
|
* |
represents less than 1% of our Common Stock |
|
(1) |
The address for each officer and directors is 9605 Medical Center, Suite 270, Rockville, Maryland
20850. |
|
(2) |
Beneficial ownership is determined in accordance with SEC rules and generally includes voting
or investment power with respect to securities. Except as indicated in the footnotes to the table, to the knowledge of the Company,
the persons named in the table have sole voting and investment power with respect to all shares of Common Stock, preferred stock,
options and/or warrants shown as beneficially owned by them, subject to community property laws, where applicable. Pursuant to the
rules of the SEC, the number of shares of our Common Stock deemed outstanding includes shares issuable pursuant to options held by
the respective person or group that are currently exercisable or may be exercised within 60 days of January 17, 2025. |
|
(3) |
As of January 17, 2025, the Company had 2,782,449 shares of Common Stock outstanding. |
|
(4) |
Includes 11,118 shares issuable upon exercise of options held by Mr. Kraws that are exercisable
within the 60-day period following January 17, 2025. |
|
(5) |
Includes 33,026 shares issuable upon exercise of options held by Mr. Shallcross and 2,867 shares
of Common Stock issuable upon exercise of options held by Mrs. Shallcross (Mr. Shallcross’s wife) that are exercisable within
the 60-day period following January 17, 2025. Does not include an additional 23,607 shares issuable upon exercise of options
held by Mr. Shallcross and 2,523 issuable upon exercise of options held by Mrs. Shallcross that are not exercisable within the 60-day
period following January 17, 2025. |
|
(6) |
Includes 11,118 shares issuable upon exercise of options held by Mr. Wolf that are exercisable
within the 60-day period following January 17, 2025. |
|
(7) |
Includes 9,900 shares issuable upon exercise of options held by Dr. Monahan that are exercisable
within the 60-day period following January 17, 2025. |
|
(8) |
Includes 225,000 shares of Common Stock. Does not include 570,000 shares of Common Stock issuable
upon exercise of Common Warrants, which warrants are subject to a beneficial ownership limit of 4.99% and, therefore, are not exercisable
since the exercise thereof would cause Armistice Capital Master Fund Ltd. to beneficially own a number of shares of Common Stock
in excess of such beneficial ownership limitations. All of the foregoing securities are directly held by Armistice Capital Master
Fund Ltd., a Cayman Islands exempted company, and may be deemed to be indirectly beneficially owned by (i) Armistice Capital LLC
(“Armistice”), as the investment manager of Armistice Capital Master Fund Ltd.; and (ii) Steven Boyd, as the Managing
Member of Armistice. Armistice and Steven Boyd disclaim beneficial ownership of the reported securities except to the extent of their
respective pecuniary interest therein. The address for Armistice Capital Master Fund Ltd. is c/o Armistice, 510 Madison Avenue, New
York, New York 10022. |
|
(9) |
Includes 180,000 shares of Common Stock. Does not include 285,000 shares of Common Stock issuable
upon exercise of Common Warrants, which warrants are subject to a beneficial ownership limit of 4.99% and, therefore, are not exercisable
since the exercise thereof would cause CVI Investments, Inc. to beneficially own a number of shares of Common Stock in excess of
such beneficial ownership limitations. Heights Capital Management, Inc., the authorized agent of CVI Investments, Inc. (“CVI”),
has discretionary authority to vote and dispose of the shares held by CVI and may be deemed to be the beneficial owner of these shares.
Martin Kobinger, in his capacity as Investment Manager of Heights Capital Management, Inc., may also be deemed to have investment
discretion and voting power over the shares held by CVI. Mr. Kobinger disclaims any such beneficial ownership of the shares. The
address of CVI is c/o Heights Capital Management, Inc., 101 California Street, Suite 3250, San Francisco, California 94111. The foregoing
is based on a Schedule 13G filed by CVI and on information available to us. |
LEGAL
MATTERS
Blank Rome LLP, New York, New York will pass upon certain legal matters
relating to the sale of the Common Warrants and Pre-Funded Warrants, offered hereby on our behalf and Parsons Behle & Latimer,
Reno, Nevada will pass on certain legal matters related to the issuance of the Common Stock, Common Warrants and Pre-Funded Warrants
offered hereby on our behalf. Additional legal matters may be passed upon for us or any underwriters, dealers, of agents, by counsel
that we will name in the applicable prospectus supplement.
Thompson Hine LLP, New York, New York, is acting as counsel to the
Placement Agent in connection with certain legal matters related to this offering.
As of the date of this prospectus, an attorney of Blank Rome LLP beneficially
owns securities exercisable to purchase shares of the Common Stock that represent less than 1% of our outstanding shares of Common Stock.
EXPERTS
The consolidated financial statements of Theriva Biologics, Inc.
as of December 31, 2023 and 2022 and for each of the two years in the period ended December 31, 2023 incorporated by reference
in this prospectus and in the registration statement have been so incorporated in reliance on the report of BDO USA, P.C, an independent
registered public accounting firm, given on the authority of said firm as experts in auditing and accounting. The report on the consolidated
financial statements contains an explanatory paragraph regarding the Company’s ability to continue as a going concern.
WHERE
YOU CAN FIND Additional INFORMATION
We have filed with the SEC a registration statement under the Securities
Act for the securities offered by this prospectus. This prospectus, which constitutes a part of the registration statement, does not
contain all of the information set forth in the registration statement or the exhibits and schedules filed therewith. For further information
about us and the securities offered hereby, we refer you to the registration statement and the exhibits and schedules filed thereto.
Any statements made in this prospectus concerning legal documents are not necessarily complete and you should read the documents that
are filed as exhibits to the registration statement or otherwise filed with the SEC for a more complete understanding of the document
or matter.
We file annual, quarterly and current reports, proxy statements and
other information with the SEC. Our SEC filings are available to the public at the SEC’s website at www.sec.gov. We are
subject to the information and periodic reporting requirements of the Exchange Act, and we file periodic reports, proxy statements and
other information with the SEC. These periodic reports, proxy statements and other information are available at the website of the SEC
referred to above. We maintain a website at https://ir.therivabiologics.com/sec-filings. You may access our Annual Reports on
Form 10-K, Quarterly Reports on Form 10-Q, Current Reports on Form 8-K and amendments to those reports filed or furnished
pursuant to Section 13(a) or 15(d) of the Exchange Act with the SEC free of charge at our website as soon as reasonably
practicable after such material is electronically filed with, or furnished to, the SEC. The information contained in, or that can be
accessed through, our website is not incorporated by reference in, and is not part of, this prospectus.
INCORPORATION
OF CERTAIN INFORMATION BY REFERENCE
The SEC allows us to “incorporate by reference” information
from other documents that we file with it, which means that we can disclose important information to you by referring you to those documents.
The information incorporated by reference is considered to be part of this prospectus. Information in this prospectus supersedes information
incorporated by reference that we filed with the SEC prior to the date of this prospectus.
We incorporate by reference into this prospectus and the registration
statement of which this prospectus is a part the information or documents listed below that we have filed with the SEC (Commission File
No. 001-12584):
| · | Our
Current Reports on Form 8-K filed with the SEC on February 7,
2024, April 22,
2024 (other than as set forth therein), April 23,
2024 (other than as set forth therein), May 2,
2024, May 16,
2024, May 23,
2024 (other than as set forth therein), July 31,
2024 (other than as set forth therein), August 16,
2024, August 26,
2024, September 9,
2024, September 16,
2024 (other than as set forth therein), September 23,
2024 (other than as set forth therein), September 30,
2024, October 3,
2024 (other than as set forth therein), October 16,
2024 (other than as set forth therein), November 1,
2024; and December 5,
2024 (other than as set forth therein). |
| · | The
description of the Common Stock set forth in (i) our registration statements on Form 8-A12B,
filed with the SEC on June 20, 2007 (File No. 001-12584) and (ii) Exhibit 4.3—Description
of Securities to our Annual Report on Form 10-K for the fiscal year ended December 31,
2023. |
We also incorporate by reference any future filings (other than current
reports furnished under Item 2.02 or Item 7.01 of Form 8-K and exhibits filed on such form that are related to such items
unless such Form 8-K expressly provides to the contrary) made with the SEC pursuant to Sections 13(a), 13(c), 14 or 15(d) of
the Exchange Act, including those made (i) on or after the date of the initial filing of the registration statement of which this
prospectus forms a part and prior to effectiveness of such registration statement, and (ii) on or after the date of this prospectus
but prior to the termination of the offering (i.e., until the earlier of the date on which all of the securities registered hereunder
have been sold or the registration statement of which this prospectus forms a part has been withdrawn). Information in such future filings
updates and supplements the information provided in this prospectus. Any statements in any such future filings will automatically be
deemed to modify and supersede any information in any document we previously filed with the SEC that is incorporated or deemed to be
incorporated herein by reference to the extent that statements in the later filed document modify or replace such earlier statements.
We will furnish without charge to each person, including any beneficial
owner, to whom a prospectus is delivered, upon written or oral request, a copy of any or all of the documents incorporated by reference
into this prospectus but not delivered with the prospectus, including exhibits that are specifically incorporated by reference into such
documents. You should direct any requests for documents to:
Theriva Biologics, Inc.
9605 Medical Center Drive, Suite 270
Rockville, Maryland 20850
Telephone: (301) 417-4364
Attention: Corporate Secretary
You may also access these documents, free of charge, on the SEC’s
website at www.sec.gov or on our website at https://ir.therivabio.com/sec-filings. The information contained in, or that
can be accessed through, our website is not incorporated by reference in, and is not part of, this prospectus or any accompanying prospectus
supplement.
In accordance with Rule 412 of the Securities Act, any statement
contained in a document incorporated by reference herein shall be deemed modified or superseded to the extent that a statement contained
herein or in any other subsequently filed document which also is or is deemed to be incorporated by reference herein modifies or supersedes
such statement.
You should rely only on information contained in, or incorporated
by reference into, this prospectus and any prospectus supplement. We have not authorized anyone to provide you with information different
from that contained in this prospectus or incorporated by reference into this prospectus. We are not making offers to sell the securities
in any jurisdiction in which such an offer or solicitation is not authorized or in which the person making such offer or solicitation
is not qualified to do so or to anyone to whom it is unlawful to make such an offer or solicitation.
Up to 6,756,756 Shares of Common Stock
Up to 6,756,756 Common Warrants to Purchase Up to 6,756,756 Shares of Common Stock
Up to 6,756,756 Pre-Funded Warrants to Purchase Up to 6,756,756 Shares of Common Stock
Up to 13,513,512 Shares of Common Stock Underlying the Common Warrants and Pre-Funded Warrants
PROSPECTUS
Sole Placement Agent
A.G.P.
, 2025
PART II
INFORMATION
NOT REQUIRED IN PROSPECTUS
Item 13. Other Expenses of Issuance and Distribution
The following table sets forth all expenses to be paid by the registrant,
other than any estimated placement agent fee and reimbursements, in connection with the offering and sale of the shares of Common Stock
being registered. All amounts shown are estimates except for the SEC registration fee.
|
|
Amount |
|
SEC registration fee |
|
$ |
3,062 |
|
FINRA filing fee |
|
|
3,500 |
|
Accounting fees and expenses |
|
|
30,000 |
|
Legal fees and expenses |
|
|
175,000 |
|
Other miscellaneous expenses |
|
|
38,438 |
|
Total expenses |
|
$ |
250,000 |
|
Item 14. Indemnification of Directors and Officers
Section 78.138 of the Nevada Revised Statute provides that, subject
to certain exceptions, a director or officer is not individually liable to the corporation or its stockholders or creditors for any damages
as a result of any act or failure to act in his capacity as a director or officer unless the presumption that the director or officer
acted in good faith, on an informed basis and with a view to the interest of the corporation is rebutted and it is proven that (1) his
act or failure to act constituted a breach of his fiduciary duties as a director or officer and (2) his breach of those duties involved
intentional misconduct, fraud or a knowing violation of law.
This provision is intended to afford directors and officers protection
against and to limit their potential liability for monetary damages resulting from suits alleging a breach of the duty of care by a director
or officer. As a consequence of this provision, stockholders of our company will be unable to recover monetary damages against directors
or officers for action taken by them that may constitute negligence or gross negligence in performance of their duties unless such conduct
falls within one of the foregoing exceptions. The provision, however, does not alter the applicable standards governing a director’s
or officer’s fiduciary duty and does not eliminate or limit the right of our company or any stockholder to obtain an injunction
or any other type of non-monetary relief in the event of a breach of fiduciary duty.
The Registrant’s Articles of Incorporation, as amended, and
second amended and restated bylaws provide for indemnification of directors, officers, employees or agents of the Registrant to the fullest
extent permitted by Nevada law (as amended from time to time). Section 78.7502 of the Nevada Revised Statute provides that a corporation
may indemnify any person who was or is a party or is threatened to be made a party to any threatened, pending or completed action, suit
or proceeding, whether civil, criminal, administrative or investigative, except an action by or in the right of the corporation, by reason
of the fact that the person is or was a director, officer, employee or agent of the corporation, or is or was serving at the request
of the corporation as a director, officer, employee or agent of another corporation, partnership, joint venture, trust or other enterprise
or as a manager of a limited-liability company, against expenses, including attorneys’ fees, judgments, fines and amounts paid
in settlement actually and reasonably incurred by the person in connection with the action, suit or proceeding if the person is not liable
as provided above and acted in good faith and in a manner he or she reasonably believed to be in, or not opposed to, the best interest
of a company and, with respect to any criminal action or proceeding, had no reasonable cause to behave his conduct was unlawful.
The registrant has entered into separate indemnification agreements
with each of the registrant’s directors and certain of the registrant’s officers which require the registrant, among other
things, to indemnify them against certain liabilities which may arise by reason of their status as directors or officers.
The Registrant has an insurance policy in place that covers its officers
and directors with respect to certain liabilities, including liabilities arising under the Securities Act or otherwise.
Any underwriting agreement, agency agreement, equity distribution
agreement or similar agreement that the Registrant may enter into will likely provide for indemnification by any underwriters or agents
of the Registrant, its directors, its officers who sign the registration statement and the Registrant’s controlling persons for
some liabilities, including liabilities arising under the Securities Act.
Item 15. Recent Sales of Unregistered Securities
During the last three years, we have issued unregistered securities
to the persons described below. None of these transactions involved any underwriters, underwriting discounts or commissions, or any public
offering. We believe that each transaction was exempt from the registration requirements of the Securities Act by virtue of Section 4(a)(2) thereof
and Regulation S thereof or Rule 506(b) of Regulation D thereunder as a transaction not involving a public offering other than
exchanges of securities that were exempt from the registration requirements of the Securities Act by virtue of Section 3(a)(9).
The recipients both had access, through their relationship with us, to information about us.
On March 10, 2022, we acquired all the outstanding shares of
VCN Biosciences, S.L., a corporation organized under the laws of Spain (“VCN”). As consideration for the purchase we paid
$4,700,000 (the “Closing Cash Consideration”) to Grifols Innovation and New Technologies Limited (“Grifols”),
the owner of approximately 86% of the equity of VCN, and issued to the remaining sellers and certain key employees and consultants of
VCN 1,055,812 shares of Common Stock.
On July 29, 2022, we closed a private placement offering pursuant
to the terms of a Securities Purchase Agreement (the “Purchase Agreement”) dated as of July 28, 2022 entered into with
MSD Credit Opportunity Master Fund, L.P. (the “Investor”), pursuant to which we issued and sold 275,000 shares of the Company’s
Series C Convertible Preferred Stock, par value $0.001 per share (the “Series C Preferred Stock”), and 100,000
shares of the Company’s Series D Convertible Preferred Stock, par value $0.001 per share (the “Series D Preferred
Stock,” and together with the Series C Preferred Stock, the “Preferred Stock”), at an offering price of $8.00
per share, for gross proceeds of approximately $3.0 million in the aggregate, before the deduction of discounts, fees and offering expenses,
all of which have been converted as of this date (as set forth below).
In May 2024, July 2024 and September 2024, we issued
72,132 shares of Common Stock upon the conversion effected on such dates by the holder of 275,000 shares of the Company’s Series C
Preferred Stock at a conversion price of $30.50 per share.
In September 2024, we issued 26,230 shares of Common Stock upon
the conversion effected on such date by the holder of 100,000 shares of the Company’s Series D Preferred Stock at a conversion
price of $30.50 per share.
Item 16. Exhibits and Financial Statement Schedules
The exhibits to this registration statement are listed in the Exhibit Index
to this registration statement, which immediately precedes the Signature Page and which Exhibit Index is hereby incorporated
by reference.
Item 17. Undertakings
The undersigned registrant hereby undertakes:
| (1) | To file, during any period in which offers or sales are being made,
a post-effective amendment to this registration statement: |
| i. | To include any prospectus required by Section 10(a)(3) of
the Securities Act of 1933, as amended, or the Securities Act; |
| ii. | To reflect in the prospectus any facts or events arising
after the effective date of the registration statement (or the most recent post-effective
amendment thereof) which, individually or in the aggregate, represent a fundamental change
in the information set forth in the registration statement. Notwithstanding the foregoing,
any increase or decrease in volume of securities offered (if the total dollar value of securities
offered would not exceed that which was registered) and any deviation from the low or high
end of the estimated maximum offering range may be reflected in the form of prospectus filed
with the SEC pursuant to Rule 424(b) if, in the aggregate, the changes in volume
and price represent no more than a 20% change in the maximum aggregate offering price set
forth in the “Calculation of Registration Fee” table in the effective registration
statement; and |
| iii. | To include any material information with respect to the plan of
distribution not previously disclosed in the registration statement or any material change
to such information in the registration statement; |
provided, however, that paragraphs (i), (ii) and (iii) above
do not apply if the information required to be included in a post-effective amendment by those paragraphs is contained in periodic reports
filed with or furnished to the SEC by the registrant pursuant to Section 13 or Section 15(d) of the Securities Exchange
Act of 1934, as amended, or the Exchange Act, that are incorporated by reference in the registration statement, or is contained in a
form of prospectus filed pursuant to Rule 424(b) that is a part of the registration statement.
| (2) | That, for the purpose of determining any liability under the Securities
Act, each such post-effective amendment shall be deemed to be a new registration statement
relating to the securities offered therein, and the offering of such securities at that time
shall be deemed to be the initial bona fide offering thereof. |
| (3) | To remove from registration by means of a post-effective amendment
any of the securities being registered which remain unsold at the termination of the offering. |
| (4) | That, for the purpose of determining liability under the Securities
Act of 1933 to any purchaser, each prospectus filed pursuant to Rule 424(b) as
part of a registration statement relating to an offering, other than registration statements
relying on Rule 430B or other than prospectuses filed in reliance on Rule 430A,
shall be deemed to be part of and included in the registration statement as of the date it
is first used after effectiveness. Provided, however, that no statement made in a registration
statement or prospectus that is part of the registration statement or made in a document
incorporated or deemed incorporated by reference into the registration statement or prospectus
that is part of the registration statement will, as to a purchaser with a time of contract
of sale prior to such first use, supersede or modify any statement that was made in the registration
statement or prospectus that was part of the registration statement or made in any such document
immediately prior to such date of first use. |
| (5) | That, for the purpose of determining liability under the Securities
Act of 1933 to any purchaser in the initial distribution of the securities: the undersigned
registrant undertakes that in a primary offering of securities of the undersigned registrant
pursuant to this registration statement, regardless of the underwriting method used to sell
the securities to the purchaser, if the securities are offered or sold to such purchaser
by means of any of the following communications, the undersigned registrant will be a seller
to the purchaser and will be considered to offer or sell such securities to such purchaser:
(i) any preliminary prospectus or prospectus of the undersigned registrant relating
to the offering required to be filed pursuant to Rule 424; (ii) any free writing
prospectus relating to the offering prepared by or on behalf of the undersigned registrant
or used or referred to by the undersigned registrant; (iii) the portion of any other
free writing prospectus relating to the offering containing material information about the
undersigned registrant or its securities provided by or on behalf of the undersigned registrant;
and (iv) any other communication that is an offer in the offering made by the undersigned
registrant to the purchaser. |
| (6) | That, for purposes of determining any liability under the Securities
Act, each filing of the registrant’s annual report pursuant to Section 13(a) or
Section 15(d) of the Exchange Act (and, where applicable, each filing of an employee
benefit plan’s annual report pursuant to Section 15(d) of the Exchange Act)
that is incorporated by reference in the registration statement shall be deemed to be a new
registration statement relating to the securities offered therein, and the offering of such
securities at that time shall be deemed to be the initial bona fide offering thereof. |
| (7) | Insofar as indemnification for liabilities arising under the Securities
Act may be permitted to directors, officers and controlling persons of the registrant pursuant
to the foregoing provisions or otherwise, the registrant has been advised that in the opinion
of the SEC such indemnification is against public policy as expressed in the Securities Act
and is, therefore, unenforceable. In the event that a claim for indemnification against such
liabilities (other than the payment by the registrant of expenses incurred or paid by a director,
officer or controlling person of the registrant in the successful defense of any action,
suit or proceeding) is asserted by such director, officer or controlling person in connection
with the securities being registered, the registrant will, unless in the opinion of its counsel
the matter has been settled by controlling precedent, submit to a court of appropriate jurisdiction
the question whether such indemnification by it is against public policy as expressed in
the Securities Act and will be governed by the final adjudication of such issue. |
EXHIBIT INDEX
The following is a list of exhibits filed as a part of this registration
statement:
The exhibits listed in the accompanying Exhibit Index are filed
or incorporated by reference as part of this registration statement.
Exhibit
No. |
|
Description |
1.1 |
|
Amended
and Restated At Market Issuance Sales Agreement by and among Theriva Biologics, Inc., B. Riley Securities, Inc. and A.G.P./Alliance
Global Partners, dated February 9, 2021 (Incorporated by reference to Exhibit 1.1 of the Registrant’s Current Report
on Form 8-K filed February 10, 2021), File No. 001-12584.) |
1.2 |
|
Amendment
No. 1, dated May 3, 2021, to the Amended and Restated At Market Issuance Sales Agreement by and among Theriva Biologics, Inc.,
B. Riley Securities, Inc. and A.G.P./Alliance Global Partners, dated February 9, 2021 ((Incorporated by reference to Exhibit 1.2
of the Registrant’s Current Report on Form 8-K filed May 3, 2021) |
1.3 |
|
Amendment
No. 2, dated May 2, 2024, to the Amended and Restated At Market Issuance Sales Agreement by and among Theriva Biologics, Inc.,
and A.G.P./Alliance Global Partners, dated February 9, 2021 (Incorporated by reference to Exhibit 10.3 of the Registrant’s
Current Report on Form 8-K filed May 2, 2024) |
1.4# |
|
Form of
Placement Agency Agreement |
2.1 |
|
Share
Purchase Agreement by and among Theriva Biologics, Inc., VCN Biosciences, S.L. and the shareholders of VCN Biosciences, S.L.
dated December 14, 2021(Incorporated by reference to Exhibit 2.1 of the Registrant’s Current Report on Form 8-K
filed December 14, 2021, File No. 001-12584.) |
2.2 |
|
Amendment,
dated March 9, 2022, to the Share Purchase Agreement, by and among Theriva Biologics, Inc., VCN Biosciences, S.L. and the
shareholders of VCN Biosciences, S.L., dated December 14, 2021 (Incorporated by reference to Exhibit 2.2 of the Registrant’s
Current Report on Form 8-K filed March 11, 2022, File No. 001-12584.) |
3.1 |
|
Certificate of Incorporation, as amended (Incorporated by reference to (i) Exhibit 3.1
of the Registrant’s Current Report on Form 8-K filed October 16, 2008, File No. 001-12584, (ii) Exhibit 3.1
of the Registrant’s Quarterly Report on Form 10-Q for the quarterly period ended June 30, 2001 filed August 14,
2001, File No. 001-12584; and (iii) Exhibits 3.1,
4.1 and
4.2 of
the Registrant’s Quarterly Report on Form 10-Q for the quarterly period ended June 30, 1998 filed August 14,
1998, File No. 001-12584.) |
3.2 |
|
Articles
of Merger (Incorporated by reference to Exhibit 3.1 of the Registrant’s Current Report on Form 8-K filed October 19,
2009, File No. 001-12584.) |
3.3 |
|
Certificate
of Merger filed with the Secretary of State of Delaware (Incorporated by reference to Exhibit 3.2 of the Registrant’s
Current Report on Form 8-K filed October 19, 2009, File No. 001-12584.) |
3.4 |
|
Articles
of Incorporation filed with the Nevada Secretary of State (Incorporated by reference to Exhibit 3.3 of the Registrant’s
Current Report on Form 8-K filed October 19, 2009, File No. 001-12584.) |
3.5 |
|
Certificate
of Amendment to Articles of Incorporation (Incorporated by reference to Exhibit 3.1 of the Registrant’s Current Report
on Form 8-K filed February 16, 2012, File No. 001-12584.) |
3.6 |
|
Certificate
of Amendment to Certificate of Incorporation. (Incorporated by reference to Exhibit 3.1 of the Registrant's Current Report on
Form 8-K filed May 18, 2015, File No. 001-12584.) |
3.7 |
|
Certificate
of Amendment to Certificate of Incorporation. (Incorporated by reference to Exhibit 3.1 of the Registrant’s Current Report
on Form 8-K filed September 8, 2017, File No. 001-12584.) |
3.8 |
|
Certificate
of Designations for Series A Preferred Stock to Certificate of Incorporation (Incorporated by reference to Exhibit 3.1
of the Registrant’s Current Report on Form 8-K filed September 12, 2017, File No. 001-12584.) |
3.9 |
|
Certificate
of Change Pursuant to NRS 78. 209 (Incorporated by reference to Exhibit 3.1 of the Registrant’s Current Report on Form 8-K
filed August 13, 2018, File No. 001-12584.) |
3.10 |
|
Certificate
of Amendment to Articles of Incorporation (Incorporated by reference to Exhibit 3.1 of the Registrant’s Current Report
on Form 8-K filed September 26, 2018, File No. 001-12584.) |
3.11 |
|
Certificate
of Designations for Series B Preferred Stock to Certificate of Incorporation (Incorporated by reference to Exhibit 3.1
of the Registrant’s Current Report on Form 8-K filed October 15, 2018, File No. 001-12584.) |
3.12 |
|
Certificate
of Amendment to Certificate of Designations for Series B Preferred Stock to Certificate of Incorporation (Incorporated by reference
to Exhibit 3.2 of the Registrant’s Current Report on Form 8-K filed October 15, 2018, File No. 001-12584.) |
3.13 |
|
Certificate
of Amendment to the Certificate of Designation for the Series A Convertible Preferred Stock (Incorporated by reference to Exhibit 3.1
of the Registrant’s Current Report on Form 8-K/A filed on February 1, 2021 File No. 001-12584.) |
3.14 |
|
Certificate
of Change filed with the Secretary of State of the State of Nevada on July 21, 2022 (effective as of July 25, 2022) (Incorporated
by reference to Exhibit 3.1 of the Registrant’s Current Report on Form 8-K filed on July 25, 2022 (File No. 001-12584.) |
3.15 |
|
Form of
Certificate of Designation of Series C Convertible Preferred Stock (Incorporated by reference to Exhibit 3.1 of the Registrant’s
Current Report on Form 8-K filed on July 29, 2022 (File No. 001-12584.) |
3.16 |
|
Form of
Certificate of Designation of Series D Convertible Preferred Stock (Incorporated by reference to Exhibit 3.2 of the Registrant’s
Current Report on Form 8-K filed on July 29, 2022 (File No. 001-12584.) |
3.17 |
|
Certificate
of Amendment to Articles of Incorporation (Incorporated by reference to Exhibit 3.1 of the Registrant’s Current Report
on Form 8-K filed on October 12, 2022 (File No. 001-12584.) |
3.18 |
|
Certificate
of Change to Articles of Incorporation (Incorporated by reference to Exhibit 3.2 of the Registrant’s Current Report on
Form 8-K filed on October 12, 2022 (File No. 001-12584.) |
3.19 |
|
Certificate
of Change filed with the Secretary of State of the State of Nevada on August 22, 2024 (effective as of August 26, 2024)
(Incorporated by reference to Exhibit 3.1 of the Registrant’s Current Report on Form 8-K filed August 26, 2024,
File No. 001-12584.) |
3.20 |
|
Second
Amended and Restated Bylaws (Incorporated by reference to Exhibit 3.1 of the Registrant’s Current Report on Form 8-K
filed August 11, 2023, File No. 001-12584.) |
3.21 |
|
Certificate
of Change to the Articles of Incorporation (Incorporated by reference to Exhibit 3.1 of the Registrant’s Current
Report on Form 8-K filed November 1, 2024, File No. 001-12584.) |
4.1 |
|
Specimen
Stock Certificate (Incorporated by reference to Exhibit 4.1 to the Registrant’s Registration Statement on Form S-3
filed on July 3, 2013, File No. 333-189794.) |
4.2 |
|
Form of
Warrant issued December 26, 2017 to InSite Communications (Incorporated by reference to Exhibit 4.1 of the Registrant’s
Current Report on Form 10-Q filed May 8, 2018, File No. 001-12584.) |
4.3 |
|
Form of
Common Warrant (Incorporated by reference to Exhibit 4.1 of the Registrant’s Current Report on Form 8-K filed September 30,
2024, File No. 001-12584.) |
4.4 |
|
Form of
Pre-Funded Warrant (Incorporated by reference to Exhibit 4.2 of the Registrant’s Current Report on Form 8-K filed
September 30, 2024, File No. 001-12584.) |
4.5^ |
|
Form of Common
Warrant |
4.6^ |
|
Form of Pre-Funded
Warrant |
5.1(a)^ |
|
Opinion of Parsons Behle & Latimer |
5.1(b)^ |
|
Opinion of Blank Rome LLP |
10.1* |
|
2007
Stock Incentive Plan (Incorporated by reference to Exhibit 4.2 of the Registrant’s Registration Statement on Form S-8
filed January 18, 2008, File No. 333-148764.) |
10.2* |
|
Form of
Director/Officer Indemnification Agreement (Incorporated by reference to Exhibit 10.1 of the Registrant’s Current Report
on Form 8-K filed January 6, 2009, File No. 001-12584.) |
10.3* |
|
2010
Stock Incentive Plan (Incorporated by reference to Exhibit 4.1 of the Registrant’s Registration Statement on Form S-8
filed November 29, 2010, File No. 333-170858.) |
10.4 |
|
Asset
Purchase Agreement dated November 8, 2012 between Theriva Biologics, Inc. and Prev ABR LLC (Incorporated by reference to
Exhibit 10.4 of the Registrant's Annual Report on Form 10-K filed on March 16, 2022, File No. 001-12584) |
10.5+ |
|
Patent
License Agreement dated December 19, 2012 between Theriva Biologics, Inc. and The University of Texas at Austin (Incorporated
by reference to Exhibit 10.1 of the Registrant’s Current Report on Form 8-K filed December 21, 2012, File No. 001-12584.) |
10.6* |
|
Amended
and Restated 2010 Stock Incentive Plan (Incorporated by reference to Exhibit 4.1 to the Registrant’s Registration Statement
on Form S-8 filed on November 15, 2013, File No. 333-192355.) |
10.7* |
|
Amended
and Restated 2010 Stock Incentive Plan. (Incorporated by reference to Exhibit B to the Definitive Proxy Statement filed on April 13,
2015, File No. 001-12584.) |
10.8 |
|
Lease
dated April 14, 2015 between Registrant. and MCC3, LLC (Incorporated by reference to Exhibit 10.8 to the Registrant’s
Annual Report on Form 10-K filed on March 25, 2024, File No. 001-12584.) |
10.9* |
|
Theriva
Biologics, Inc. 2010 Stock Incentive Plan, as amended and restated on May 15, 2015. (Incorporated by reference to Exhibit 4.1
to the Registrant’s Registration Statement on Form S-8 filed on August 10, 2015, File No. 333-206268.) |
10.10* |
|
Form of
Stock Option Agreement. (Incorporated by reference to Exhibit 10.2 of the Registrant’s Current Report on Form 8-K
filed December 10, 2015, File No. 001-12584.) |
10.11* |
|
Theriva
Biologics, Inc. 2010 Stock Incentive Plan, as amended and restated on May 31, 2016. (Incorporated by reference to Exhibit 4.1
to the Registrant’s Registration Statement on Form S-8 filed on August 31, 2016, File No. 333-206268.) |
10.12* |
|
Amended
and Restated 2010 Stock Incentive Plan (Incorporated by reference to Exhibit 4.1 to the Registrant’s Registration Statement
on Form S-8 filed on September 8, 2017, File No. 333-220401.) |
10.13* |
|
Theriva
Biologics, Inc. 2010 Stock Incentive Plan, as amended (incorporated by reference to Appendix A to the Definitive Proxy Statement
filed with the Securities and Exchange Commission on July 15, 2019, File No. 001-12584) |
10.14+ |
|
Clinical
Trial Agreement between Washington University School of Medicine in St. Louis and Theriva Biologics, Inc. dated August 7,
2019 (Incorporated by reference to Exhibit 10.1 of the Registrant’s Current Report on Form 8-K filed on August 8,
2019, File No. 001-12584) |
10.15* |
|
Theriva
Biologics, Inc. 2020 Stock Incentive Plan (Incorporated by reference to Appendix A to the Registrant’s Definitive Proxy
Statement on Schedule 14A filed on August 4, 2020, File No. 001-12584) |
10.16* |
|
Form of
Incentive Stock Option Grant Agreement (Incorporated by reference to Exhibit 4.11 to the Registration Statement on Form S-8
filed on October 28, 2020, File No. 333-249712) |
10.17* |
|
Form of
Nonqualified Stock Option Grant Agreement (Incorporated by reference to Exhibit 4.12 to the Registration Statement on Form S-8
filed on October 28, 2020, File No. 333-249712) |
10.18* |
|
Form of
Restricted Stock Unit Award Agreement (Incorporated by reference to Exhibit 4.13 to the Registration Statement on Form S-8
filed on October 28, 2020, File No. 333-249712) |
10.19+ |
|
Second
Amendment to Lease dated May 6, 2021 by and between Registrant and ARE-Maryland No. 50, LLC (Incorporated by reference
to Exhibit 10.19 of the Registrant's Annual Report on Form 10-K filed on March 25, 2024, File No. 001-12584) |
10.20* |
|
Employment
Agreement with Steven Shallcross dated January 3, 2022 (Incorporated by reference to Exhibit 10.1 of the Registrant’s
Current Report on Form 8-K filed on January 4, 2022, File No. 001-12584) |
10.21+ |
|
Contract
to Grant Marketing License for Catalan Institute of Oncology Patent Ownership Application to VCN Biosciences S.L. (Incorporated by
reference to Exhibit 10.32 of the Registrant's Annual Report on Form 10-K filed on March 16, 2022, File No. 001-12584) |
10.22+ |
|
License
Agreement between Bellvitge Biomedical Research Institute Foundation (Idibell) and VCN Biosciences S.L. dated May 4, 2016 (Incorporated
by reference to Exhibit 10.33 of the Registrant's Annual Report on Form 10-K filed on March 16, 2022, File No. 001-12584) |
10.23+ |
|
Technology
Transfer Agreement between Bellvitge Biomedical Research Institute and VCN Biosciences S.L. dated August 31, 2010 (Incorporated
by reference to Exhibit 10.34 of the Registrant's Annual Report on Form 10-K filed on March 16, 2022, File No. 001-12584) |
10.24+ |
|
Collaboration
Agreement to Conduct a Clinical Trial and Grant Operating License Agreement between Hospital Sant Joan Dee Deu and VCN Biosciences,
S.L dated February 15, 2016 (Incorporated by reference to Exhibit 10.35 of the Registrant's Annual Report on Form 10-K
filed on March 16, 2022, File No. 001-12584) |
10.25* |
|
Employment
Agreement with Frank Tufaro dated March 22, 2022 (Incorporated by reference to Exhibit 10.1 of the Registrant’s Current
Report on Form 8-K filed on March 23, 2022, File No. 001-12584) |
10.26* |
|
Employment
Agreement with Mary Ann Shallcross dated April 8, 2022 (Incorporated by reference to Exhibit 10.26 of the Registrant's
Annual Report on Form 10-K filed on March 25, 2024, File No. 001-12584) |
10.27 |
|
Securities
Purchase Agreement between Synthetic Biologics Inc. and MSD Credit Opportunity Master Fund, L.P., dated as of July 28, 2022
(Incorporated by reference to Exhibit 10.1 of the Registrant’s Current Report on Form 8-K filed on July 29,
2022, File No. 001-12584) |
10.28 |
|
Amendment
No. 1 dated as of August 9, 2022 to Securities Purchase Agreement between Synthetic Biologics Inc. and MSD Credit Opportunity
Master Fund, L.P., dated as of July 28, 2022 (Incorporated by reference to Exhibit 10.2 of the Registrant’s Quarterly
Report on Form 10-Q filed on August 11, 2022, File No. 001-12584) |
10.29* |
|
Amendment
No. 1 to Employment Agreement between Theriva Biologics, Inc. and Steven A. Shallcross, dated as of December 15, 2022
(Incorporated by reference to Exhibit 10.1 of the Registrant’s Current Report on Form 8-K filed on December 20,
2022, File No. 001-12584) |
10.30* |
|
Amendment
No. 1 to Employment Agreement between Theriva Biologics, Inc. and Francis Tufaro, dated as of December 15, 2022 (Incorporated
by reference to Exhibit 10.2 of the Registrant’s Current Report on Form 8-K filed on December 20, 2022, File
No. 001-12584) |
10.31 |
|
Form of
Share Repurchase Agreement between Theriva Biologics, Inc. and certain selling stockholders (Incorporated by reference to Exhibit 10.1
of the Registrant’s Current Report on Form 8-K filed on December 23, 2022, File No. 001-12584) |
10.32* |
|
Separation
Agreement, dated as of May 8, 2023, between Theriva Biologics, Inc. and Frank Tufaro (Incorporated by reference to Exhibit 10.1
of the Registrant’s Quarterly Report on Form 10-Q filed on May 11, 2023, File No. 001-12584) |
10.33* |
|
Consulting
Agreement, dated as of May 8, 2023, between Theriva Biologics, Inc. and Frank Tufaro (Incorporated by reference to Exhibit 10.2
of the Registrant’s Quarterly Report on Form 10-Q filed on May 11, 2023, File No. 001-12584) |
10.34 |
|
Amendment
No. 2 to the Theriva Biologics, Inc. 2020 Stock Incentive Plan (Incorporated by reference to Exhibit 10.1 of the Registrant’s
Current Report on Form 8-K filed November 1, 2024, File No. 001-12584) |
10.35 |
|
Form of
Securities Purchase Agreement (Incorporated by reference to Exhibit 10.1 of the Registrant’s Current Report on Form 8-K
Filed September 30, 2024, File No. 001-12584) |
10.36# |
|
Form of
Securities Purchase Agreement |
21.1 |
|
List
of Subsidiaries (Incorporated by reference to Exhibit 21.1 of the Registrant’s Annual Report on Form 10-K filed on
March 25, 2024, File No. 001-12584) |
23.1# |
|
Consent of BDO
USA, P.C., Independent Registered Public Accounting Firm |
23.2^ |
|
Consent of Parsons Behle & Latimer (included
in Exhibit 5.1(a)) |
23.3^ |
|
Consent of Blank Rome LLP (included in Exhibit 5.1(b)) |
24.1^ |
|
Power of Attorney (included in signature page hereto) |
107^ |
|
Filing Fee Table |
# | Filed herewith. |
| |
^ | Previously filed. |
| |
* | Management contract or compensatory plan or arrangement required to be identified pursuant to Item
15(a)(3) of this report. |
| |
+ | The Company the submitted certain portions of these agreements in accordance with Item 601 (b)(10) of Regulation
S-K. The Company agrees to furnish unredacted copies of these exhibits to the SEC upon request. |
SIGNATURES
Pursuant to the requirements of the Securities Exchange Act of
1934, the registrant has duly caused this Amendment No. 1 to Registration Statement to be signed on its behalf by the undersigned
hereunto duly authorized, on this 21st day of January, 2025.
|
Theriva Biologics, Inc. |
|
|
|
By: |
/s/ Steven A. Shallcross |
|
|
Name: |
Steven A. Shallcross |
|
|
Title: |
Chief Executive Officer and Chief Financial Officer |
POWER
OF ATTORNEY
Pursuant to the requirements of the Securities Act of 1933, this
Amendment No. 1 to registration statement has been signed by the following persons in the capacities and on the dates indicated.
Signature |
|
Title |
|
Date |
|
|
|
|
|
/s/ Steven A. Shallcross |
|
Chief Executive Officer, Chief Financial Officer |
|
January 21, 2025 |
Steven A. Shallcross |
|
(Principal Executive Officer, Principal Financial Officer and Principal Accounting Officer) and Member of the Board of Directors |
|
|
|
|
|
|
|
* |
|
Member of the Board of Directors |
|
January 21, 2025 |
Jeffrey J. Kraws |
|
|
|
|
|
|
|
|
|
* |
|
Member of the Board of Directors |
|
January 21, 2025 |
Jeffrey Wolf |
|
|
|
|
|
|
|
|
|
* |
|
Member of the Board of Directors |
|
January 21, 2025 |
John Monahan, Ph.D. |
|
|
|
|
*By: |
/s/
Steven A. Shallcross |
|
|
Name: |
Steven A. Shallcross |
|
|
Title: |
Attorney-in-fact |
|
Exhibit 1.4
PLACEMENT AGENCY AGREEMENT
[_], 2025
Theriva Biologics, Inc.
9605 Medical Center Drive, Suite 270
Rockville, MD 20850
Attention: Steven A. Shallcross
Dear Mr. Shallcross:
This letter (the “Agreement”)
constitutes the agreement between A.G.P./Alliance Global Partners, as placement agent (the “Placement Agent”), and
Theriva Biologics, Inc., a company incorporated under the laws of the State of Nevada (the “Company”), that the
Placement Agent shall serve as the exclusive placement agent for the Company, on a “reasonable best efforts” basis, in connection
with the proposed placement (the “Placement”) of (i) shares (the “Shares”) of the Company’s
common stock, par value $0.001 per share (the “Common Stock”), (ii) warrants to purchase shares of Common Stock
of the Company (the “Common Warrants”), and/or (iii) pre-funded warrants to purchase shares of Common Stock (the
“Pre-Funded Warrants”, and together with the Common Warrants, the “Warrants,” and collectively with
the Shares, the “Securities”), depending on the beneficial ownership percentage of the purchaser of the Common Stock
following its purchase. The Shares, Common Warrants and Pre-Funded Warrants, along with the shares of Common Stock underlying the Pre-Funded
Warrants and Common Warrants shall be offered and sold under the Company’s registration statement on Form S-1 (File No. 333-[__])
(the “Registration Statement”). The Securities actually placed by the Placement Agent are referred to herein as the
“Placement Agent Securities.”
The terms of the Placement
shall be mutually agreed upon by the Company and the purchasers (each, a “Purchaser” and collectively, the “Purchasers”);
provided, however, that nothing herein shall obligate the Company to issue any Securities or complete the Placement. The Company
expressly acknowledges and agrees that the Placement Agent’s obligations hereunder are on a reasonable best efforts basis only and
that the execution of this Agreement does not constitute a commitment by the Placement Agent to purchase the Securities and does not ensure
the successful placement of the Securities or any portion thereof or the success of the Placement Agent with respect to securing any other
financing on behalf of the Company. The Placement Agent may retain other brokers or dealers to act as sub-agents or selected-dealers on
its behalf in connection with the Placement. Certain affiliates of the Placement Agent may participate in the Placement by purchasing
some of the Placement Agent Securities. The sale of Placement Agent Securities to any Purchaser will be evidenced by a securities purchase
agreement (the “Purchase Agreement”) between the Company and such Purchaser, in a form reasonably acceptable to the
Company and the Purchaser. Capitalized terms that are not otherwise defined herein have the meanings given to such terms in the Purchase
Agreement. Prior to the signing of any Purchase Agreement, officers of the Company will be available to answer inquiries from prospective
Purchasers.
SECTION 1. REPRESENTATIONS
AND WARRANTIES OF THE COMPANY; COVENANTS OF THE COMPANY.
A. Representations of the
Company. With respect to the Placement Agent Securities, each of the representations and warranties (together with any related disclosure
schedules thereto) and covenants made by the Company to the Purchasers in the Purchase Agreement in connection with the Placement, is
hereby incorporated herein by reference into this Agreement (as though fully restated herein) and is, as of the date of this Agreement
and as of the Closing Date, hereby made to, and in favor of, the Placement Agent. In addition to the foregoing, the Company represents
and warrants that there are no affiliations with any FINRA member firm among the Company’s officers, directors or, to the knowledge
of the Company, any five percent (5.0%) or greater stockholder of the Company, except as set forth in the Purchase Agreement, the FINRA
questionnaires and SEC Reports.
B. Covenants of the Company.
The Company covenants and agrees to continue to retain (i) an independent public accounting firm registered with the Public Company
Accounting Oversight Board (the “PCAOB”) for a period of at least three (3) years after the Closing Date and (ii) a
competent transfer agent with respect to the Placement Agent Securities for a period of three (3) years after the Closing Date. In
addition, from the date hereof until sixty (60) days after the Closing Date, subject to certain exceptions provided for in the Purchase
Agreement, neither the Company nor any Subsidiary shall issue, enter into any agreement to issue or announce the issuance or proposed
issuance of any shares of Common Stock or Common Stock Equivalents, except that such restriction shall not apply with respect to an Exempt
Issuance (as defined in the Purchase Agreement). In addition, from the date hereof until six (6) months after the Closing Date, neither
the Company nor any Subsidiary shall effect or enter into an agreement to effect any issuance by the Company or any of its Subsidiaries
of shares of Common Stock or Common Stock Equivalents (as defined in the Purchase Agreement) (or a combination of units thereof) involving
a Variable Rate Transaction (as defined in the Purchase Agreement). The foregoing shall not apply, (i) fifteen (15) days after the
Closing Date, to the filing of a prospectus supplement with respect to sales under the “at-the-market” offering with the Placement
Agent as sales agent, pursuant to the Amended and Restated At Market Issuance Sales Agreement, dated February 9, 2021, between the Company
and the Placement Agent, as amended by Amendment No. 1 thereto, dated May 3, 2021, and Amendment No. 2 thereto, dated May 2, 2024 (the
“Sales Agreement”) and (ii) forty-five (45) days afte the Closing Date, to the sale and issuance of securities in an
at-the-market offering pursuant to the Sales Agreement.
SECTION 2. REPRESENTATIONS
OF THE PLACEMENT AGENT. The Placement Agent represents and warrants that it (i) is a member in good standing of FINRA, (ii) is
registered as a broker/dealer under the Exchange Act, (iii) is licensed as a broker/dealer under the laws of the United States of
America, applicable to the offers and sales of the Placement Agent Securities by the Placement Agent, (iv) is and will be a corporate
body validly existing under the laws of its place of incorporation, and (v) has full power and authority to enter into and perform
its obligations under this Agreement. The Placement Agent will immediately notify the Company in writing of any change in its status with
respect to subsections (i) through (v) above. The Placement Agent covenants that it will use its reasonable best efforts to
conduct the Placement hereunder in compliance with the provisions of this Agreement and the requirements of applicable law.
SECTION 3. COMPENSATION
AND EXPENSES.
A. In consideration of the
services to be provided for hereunder, the Company shall pay to the Placement Agent or its respective designees a total cash fee equal
to seven percent (7.0%) of the gross proceeds from the total amount of Placement Agent Securities sold in the Placement (the “Cash
Fee”). The Cash Fee shall be paid on the Closing Date. The Company shall not be required to pay the Placement Agent any fees
or expenses except for the Cash Fee and the reimbursement of (i) accountable legal fees and other reasonable and documented out-of-pocket
expenses incurred by the Placement Agent in connection with the transaction in the amount of up to $85,000 and (ii) non-accountable
expenses equal to $15,000. The Placement Agent reserves the right to reduce any item of compensation or adjust the terms thereof as specified
herein in the event that a determination shall be made by FINRA to the effect that the Placement Agent’s aggregate compensation
is in excess of FINRA Rules or that the terms thereof require adjustment. Notwithstanding the foregoing, upon a termination of this
Agreement the fees owed by the Company under this paragraph 3.A. shall be reduced to a maximum of $25,000.
B. The Company agrees to pay
all costs, fees and expenses incurred by the Company in connection with the performance of its obligations hereunder and in connection
with the transactions contemplated hereby, including, without limitation: (i) all expenses incident to the issuance, delivery and
qualification of the Placement Agent Securities (including all printing and engraving costs); (ii) all fees and expenses of the registrar
and transfer agent of the Shares; (iii) all necessary issue, transfer and other stamp taxes in connection with the issuance and sale
of the Placement Agent Securities; (iv) all fees and expenses of the Company’s counsel, independent public or certified public
accountants and other advisors; (v) all costs and expenses incurred in connection with the preparation, printing, filing, shipping
and distribution of the Registration Statement (including financial statements, exhibits, schedules, consents and certificates of experts),
the Preliminary Prospectus and the Prospectus, and all amendments and supplements thereto, and this Agreement; (vi) all filing fees,
reasonable attorneys’ fees and expenses incurred by the Company in connection with qualifying or registering (or obtaining exemptions
from the qualification or registration of) all or any part of the Placement Agent Securities for offer and sale under the state securities
or blue sky laws or the securities laws of any other country; and (vii) the fees and expenses associated with including the Placement
Agent Securities on the Trading Market.
SECTION 4. INDEMNIFICATION.
A. To the extent permitted
by law, with respect to the Placement Agent Securities, the Company will indemnify the Placement Agent and its affiliates, stockholders,
directors, officers, employees, members and controlling persons (within the meaning of Section 15 of the Securities Act or Section 20
of the Exchange Act) against all losses, claims, damages, expenses and liabilities, as the same are incurred (including the reasonable
fees and expenses of counsel), relating to or arising out of its activities hereunder or pursuant to this Agreement, except to the extent
that any losses, claims, damages, expenses or liabilities (or actions in respect thereof) are found in a final judgment (not subject to
appeal) by a court of law to have resulted from a Placement Agent’s fraud, willful misconduct or gross negligence in executing this
Agreement or performing the services described herein. For the avoidance of doubt, this Section 4 is not intended to govern claims
between the parties hereto.
B. Promptly after receipt
by the Placement Agent of notice of any claim or the commencement of any action or proceeding with respect to which the Placement Agent
is entitled to indemnity hereunder, the Placement Agent will notify the Company in writing of such claim or of the commencement of such
action or proceeding, but failure to so notify the Company shall not relieve the Company from any obligation it may have hereunder, except
and only to the extent such failure results in the forfeiture by the Company of substantial rights or defenses or prejudice to the Company’s
substantial rights or defenses. If the Company so elects or is requested by the Placement Agent, the Company will assume the defense of
such action or proceeding and will employ counsel reasonably satisfactory to the Placement Agent and will pay the fees and expenses of
such counsel. Notwithstanding the preceding sentence, the Placement Agent will be entitled to employ its own counsel separate from counsel
for the Company and from any other party in such action if counsel for the Placement Agent reasonably determines that it would be inappropriate
under the applicable rules of professional responsibility for the same counsel to represent both the Company and the Placement Agent.
In such event, the reasonable fees and disbursements of no more than one such separate counsel will be paid by the Company, in addition
to fees of local counsel. The Company will have the right to settle the claim or proceeding, provided that the Company will not settle
any such claim, action or proceeding without the prior written consent of the Placement Agent, which will not be unreasonably withheld
or delayed unless such settlement includes an unconditional, irrevocable release of each Indemnified Person from any and all liability
arising out of such claim.
C. The Company agrees to notify
the Placement Agent promptly of the assertion against it or any other person of any claim or the commencement of any action or proceeding
relating to a transaction contemplated by this Agreement.
D. If for any reason the foregoing
indemnity is unavailable to the Placement Agent or insufficient to hold the Placement Agent harmless, then the Company shall contribute
to the amount paid or payable by the Placement Agent as a result of such losses, claims, damages or liabilities in such proportion as
is appropriate to reflect not only the relative benefits received by the Company on the one hand and the Placement Agent on the other,
but also the relative fault of the Company on the one hand and the Placement Agent on the other that resulted in such losses, claims,
damages or liabilities, as well as any relevant equitable considerations. The amounts paid or payable by a party in respect of losses,
claims, damages and liabilities referred to above shall be deemed to include any legal or other fees and expenses incurred in defending
any litigation, proceeding or other action or claim. Notwithstanding the provisions hereof, the liable Placement Agent’s share of
the liability hereunder shall not be in excess of the amount of fees actually received, or to be received, by the Placement Agent under
this Agreement (excluding any amounts received as reimbursement of expenses incurred by the Placement Agent).
E. These indemnification provisions
shall remain in full force and effect whether or not the transaction contemplated by this Agreement is completed and shall survive the
expiration or termination of this Agreement, and shall be in addition to any liability that the Company might otherwise have to any indemnified
party under this Agreement or otherwise.
SECTION 5. ENGAGEMENT
TERM. The Placement Agent’s engagement hereunder will be until the earlier of (i) February 12, 2025 and (ii) the Closing
Date. The date of termination of this Agreement is referred to herein as the “Termination Date.” In the event, however,
in the course of the Placement Agent’s performance of due diligence it deems, it necessary to terminate the engagement, the Placement
Agent may do so prior to the Termination Date. The Company may elect to terminate the engagement hereunder for any reason prior to the
Termination Date but will remain responsible for up to $25,000 of expenses incurred by the Placement Agent. The Placement Agent agrees
not to use any confidential information concerning the Company provided to the Placement Agent by the Company for any purposes other than
those contemplated under this Agreement.
SECTION 6. PLACEMENT
AGENT INFORMATION. The Company agrees that any information or advice rendered by the Placement Agent in connection with this engagement
is for the confidential use of the Company only in its evaluation of the Placement and, except as otherwise required by law, the Company
will not disclose or otherwise refer to the advice or information in any manner without the Placement Agent’s prior written consent.
SECTION 7. NO
FIDUCIARY RELATIONSHIP. This Agreement does not create, and shall not be construed as creating rights enforceable by any person or
entity not a party hereto, except those entitled hereto by virtue of the indemnification provisions hereof. The Company acknowledges and
agrees that the Placement Agent is not and shall not be construed as a fiduciary of the Company and shall have no duties or liabilities
to the equity holders or the creditors of the Company or any other person by virtue of this Agreement or the retention of the Placement
Agent hereunder, all of which are hereby expressly waived.
SECTION 8. CLOSING.
The obligations of the Placement Agent, and the closing of the sale of the Placement Agent Securities hereunder are subject to the accuracy,
when made and on the Closing Date, of the representations and warranties on the part of the Company contained herein and in the Purchase
Agreement, to the performance by the Company of its obligations hereunder, and to each of the following additional terms and conditions,
except as otherwise disclosed to and acknowledged and waived by the Placement Agent:
A. All corporate proceedings
and other legal matters incident to the authorization, form, execution, delivery and validity of each of this Agreement, the Placement
Agent Securities, and all other legal matters relating to this Agreement and the transactions contemplated hereby with respect to the
Placement Agent Securities shall be reasonably satisfactory in all material respects to the Placement Agent.
B. The Placement Agent shall
have received from Company Counsel and Company Nevada Counsel such counsel’s written opinion with respect to the Placement Agent
Securities and negative assurance letter (with respect to the Company Counsel), addressed to the Placement Agent and, with respect to
the opinion, the Purchasers, dated as of the Closing Date, in form and substance reasonably satisfactory to the Placement Agent.
C. The Common Stock shall
be registered under the Exchange Act and, as of the Closing Date, the Placement Agent Securities shall be listed and admitted and authorized
for trading on the Trading Market or other applicable U.S. national exchange and satisfactory evidence of such action shall have been
provided to the Placement Agent. The Company shall have taken no action designed to, or likely to have the effect of terminating the registration
of the Common Stock under the Exchange Act or removing or suspending from trading the Common Stock from the Trading Market or other applicable
U.S. national exchange, nor has the Company received any information suggesting that the Commission or the Trading Market or other U.S.
applicable national exchange is contemplating terminating such registration or listing.
D. No action shall have been
taken and no statute, rule, regulation or order shall have been enacted, adopted or issued by any governmental agency or body which would,
as of the Closing Date, prevent the issuance or sale of the Placement Agent Securities or materially and adversely affect or potentially
and adversely affect the business or operations of the Company; and no injunction, restraining order or order of any other nature by any
federal or state court of competent jurisdiction shall have been issued as of the Closing Date which would prevent the issuance or sale
of the Placement Agent Securities or materially and adversely affect or potentially and adversely affect the business or operations of
the Company.
E. The Company shall have
entered into a Purchase Agreement with each of the Purchasers of the Placement Agent Securities that choose to do so and such agreements
shall be in full force and effect and shall contain representations, warranties and covenants of the Company as agreed upon between the
Company and the Purchasers.
F. FINRA shall have raised
no objection to the fairness and reasonableness of the terms and arrangements of this Agreement. In addition, the Company shall, if requested
by the Placement Agent, make or authorize Placement Agent’s counsel to make on the Company’s behalf, any filing with the FINRA
Corporate Financing Department pursuant to FINRA Rule 5110, if applicable, with respect to the Placement and pay all filing fees
required in connection therewith.
G. The Placement Agent shall
have received customary certificates of the Company’s executive officers (the “Officer’s Certificate”) as
to the accuracy of the representations and warranties contained in the Purchase Agreement, and a certificate of the Company’s secretary
(the “Secretary’s Certificate”) certifying (i) that the Company’s organizational documents are true
and complete, have not been modified and are in full force and effect; (ii) that the resolutions of the Company’s Board of
Directors relating to the Placement are in full force and effect and have not been modified; and (iii) as to the incumbency of the
officers of the Company. Each of the Officer’s Certificate and Secretary’s Certificate shall be dated as of the Closing Date,
and all documents referenced in the Secretary’s Certificate shall be attached thereto.
H. The Placement Agent shall
have received an executed Lock-Up Agreement from each of the Company’s directors, officers and 5% stockholders prior to the Closing
Date.
I. On the date hereof, the
Placement Agent shall have received, a letter from BDO USA, P.C (the independent registered public accounting firm of the Company), addressed
to the Placement Agent, dated as of the date hereof, and a bring-down “comfort letter”
addressed to the Placement Agent on the Closing Date, each in form and substance satisfactory to the Placement Agent. The letters
shall not disclose any change in the condition (financial or other), earnings, operations or business of the Company, which, in the Placement
Agent’s sole judgment, is material and adverse and that makes it, in the Placement Agent’s sole judgment, impracticable or
inadvisable to proceed with the Placement of the Securities.
If any of the conditions specified
in this Section 8 shall not have been fulfilled when and as required by this Agreement, all obligations of the Placement Agent hereunder
may be cancelled by the Placement Agent at, or at any time prior to, the Closing Date. Notice of such cancellation shall be given to the
Company in writing or orally. Any such oral notice shall be confirmed promptly thereafter in writing.
SECTION 9. GOVERNING
LAW. This Agreement will be governed by, and construed in accordance with, the laws of the State of New York applicable to agreements
made and to be performed entirely in such State. This Agreement may not be assigned by either party without the prior written consent
of the other party. This Agreement shall be binding upon and inure to the benefit of the parties hereto, and their respective successors
and permitted assigns. Any right to trial by jury with respect to any dispute arising under this Agreement or any transaction or conduct
in connection herewith is waived. Any dispute arising under this Agreement may be brought into the courts of the State of New York or
into the Federal Court located in New York, New York and, by execution and delivery of this Agreement, the Company hereby accepts for
itself and in respect of its property, generally and unconditionally, the jurisdiction of aforesaid courts. Each party hereto hereby irrevocably
waives personal service of process and consents to process being served in any such suit, action or proceeding by delivering a copy thereof
via overnight delivery (with evidence of delivery) to such party at the address in effect for notices to it under this Agreement and agrees
that such service shall constitute good and sufficient service of process and notice thereof. Nothing contained herein shall be deemed
to limit in any way any right to serve process in any manner permitted by law. If either party shall commence an action or proceeding
to enforce any provisions of this Agreement, then the prevailing party in such action or proceeding shall be reimbursed by the other party
for its attorney’s fees and other costs and expenses incurred with the investigation, preparation and prosecution of such action
or proceeding.
SECTION 10. ENTIRE
AGREEMENT/MISCELLANEOUS. This Agreement embodies the entire agreement and understanding between the parties hereto, and supersedes
all prior agreements and understandings, relating to the subject matter hereof. If any provision of this Agreement is determined to be
invalid or unenforceable in any respect, such determination will not affect such provision in any other respect or any other provision
of this Agreement, which will remain in full force and effect. This Agreement may not be amended or otherwise modified or waived except
by an instrument in writing signed by the Placement Agent and the Company. The representations, warranties, agreements and covenants contained
herein shall survive the Closing Date of the Placement and delivery of the Placement Agent Securities. This Agreement may be executed
in two or more counterparts, all of which when taken together shall be considered one and the same agreement and shall become effective
when counterparts have been signed by each party and delivered to the other party, it being understood that both parties need not sign
the same counterpart. In the event that any signature is delivered by facsimile transmission or a .pdf format file, such signature shall
create a valid and binding obligation of the party executing (or on whose behalf such signature is executed) with the same force and effect
as if such facsimile or .pdf signature page were an original thereof.
SECTION 11. NOTICES.
Any and all notices or other communications or deliveries required or permitted to be provided hereunder shall be in writing and shall
be deemed given and effective on the earliest of (a) the date of transmission, if such notice or communication is sent to the email
address specified on the signature pages attached hereto prior to 6:30 p.m. (New York City time) on a business day, (b) the
next business day after the date of transmission, if such notice or communication is sent to the email address on the signature pages attached
hereto on a day that is not a business day or later than 6:30 p.m. (New York City time) on any business day, (c) the third business
day following the date of mailing, if sent by U.S. internationally recognized air courier service, or (d) upon actual receipt by
the party to whom such notice is required to be given. The address for such notices and communications shall be as set forth on the signature
pages hereto.
SECTION 12. PRESS
ANNOUNCEMENTS. The Company agrees that the Placement Agent shall, on and after the Closing Date, have the right to reference the Placement
and the Placement Agent’s role in connection therewith in the Placement Agent’s marketing materials and on its website and
to place advertisements in financial and other newspapers and journals, in each case at its own expense.
[The remainder of this page has been intentionally
left blank.]
Please confirm that the foregoing correctly sets
forth our agreement by signing and returning to the Placement Agents the enclosed copy of this Agreement.
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Very truly yours, |
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A.G.P./ALLIANCE GLOBAL PARTNERS |
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By: |
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Name: |
Thomas Higgins |
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Title: |
Managing Director |
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Address for notice: |
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590 Madison Avenue 28th Floor New York, |
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New York 10022 |
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Attn: Thomas Higgins |
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Email: |
[Signature Page to Placement Agency Agreement.]
Accepted and Agreed to as of the date first written above:
THERIVA BIOLOGICS, INC. |
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By: |
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Name: |
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Title: |
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Address for notice:
9605 Medical Center Drive, Suite 270
Rockville, MD 20850
Attention: [·]
Email: [·] |
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[Signature Page to Placement Agency Agreement.]
Exhibit 10.36
SECURITIES PURCHASE AGREEMENT
This SECURITIES PURCHASE AGREEMENT
(this “Agreement”) is dated as of [●], 2025, between Theriva Biologics, Inc., a Nevada corporation (the
“Company”), and each purchaser identified on the signature pages hereto (each, including its successors and assigns,
a “Purchaser” and collectively the “Purchasers”).
WHEREAS, subject to the terms
and conditions set forth in this Agreement and pursuant to an effective registration statement under the Securities Act (as defined below),
the Company desires to issue and sell to each Purchaser, and each Purchaser, severally and not jointly, desires to purchase from the Company,
securities of the Company as more fully described in this Agreement.
NOW, THEREFORE, IN CONSIDERATION
of the mutual covenants contained in this Agreement, and for other good and valuable consideration the receipt and adequacy of which are
hereby acknowledged, the Company and each Purchaser agree as follows:
Section 1.
DEFINITIONS
1.1 |
Definitions. In addition to the terms defined elsewhere in this Agreement, for all purposes of this Agreement, the following terms have the meanings set forth in this Section 1.1: |
“Acquiring Person”
shall have the meaning ascribed to such term in Section 4.5.
“Action”
shall have the meaning ascribed to such term in Section 3.1(j).
“Affiliate”
means any Person that, directly or indirectly through one or more intermediaries, controls or is controlled by or is under common control
with a Person as such terms are used in and construed under Rule 405 under the Securities Act.
“Board of Directors”
means the board of directors of the Company.
“Business Day”
means any day other than Saturday, Sunday, or other day on which banking institutions in the State of New York are authorized or required
by law to remain closed.
“Closing”
means the closing of the purchase and sale of the Securities pursuant to Section 2.1.
“Closing Date”
means the Trading Day on which all of the Transaction Documents have been executed and delivered by the applicable parties thereto, and
all conditions precedent to (i) the Purchasers’ obligations to pay the Subscription Amount at the Closing and (ii) the
Company’s obligations to deliver the Securities, in each case, at the Closing have been satisfied or waived, but in no event later
than the second (2nd) Trading Day following the date hereof.
“Commission”
means the United States Securities and Exchange Commission.
“Common Stock”
means the common stock of the Company, par value $0.001 per share.
“Common Stock Equivalents”
means any securities of the Company or the Subsidiaries which would entitle the holder thereof to acquire at any time Common Stock, including,
without limitation, any debt, preferred stock, right, option, warrant or other instrument that is at any time convertible into or exercisable
or exchangeable for, or otherwise entitles the holder thereof to receive, Common Stock.
“Common Warrants”
means the common warrants delivered to the Purchasers at Closing in accordance with Section 2.2(a) hereof, which common warrants
shall be exercisable immediately upon issuance and may be exercised during a period of five years commencing from their issuance, in the
form of Exhibit A attached hereto.
“Company Counsel”
means Blank Rome LLP, with offices located at 1271 Avenue of The Americas, New York, NY 10020.
“Company Nevada Counsel”
means Parsons Behle & Latimer, with offices located at 50 West Liberty Street, Suite 750, Reno, Nevada 89501.
“Disclosure Schedules”
means the Disclosure Schedules of the Company delivered concurrently herewith.
“Disclosure Time”
means, (i) if this Agreement is signed on a day that is not a Trading Day or after 9:00 a.m. (New York City time) and before
midnight (New York City time) on any Trading Day, 9:01 a.m. (New York City time) on the Trading Day immediately following the date
hereof, unless otherwise instructed as to an earlier time by the Placement Agent, and (ii) if this Agreement is signed between midnight
(New York City time) and 9:00 a.m. (New York City time) on any Trading Day, no later than 9:01 a.m. (New York City time) on
the date hereof, unless otherwise instructed as to an earlier time by the Placement Agent.
“DVP” shall
have the meaning ascribed to such term in Section 2.1(v).
“Evaluation Date”
shall have the meaning ascribed to such term in Section 3.1(r).
“Exchange Act”
means the Securities Exchange Act of 1934, as amended, and the rules and regulations promulgated thereunder.
“Exempt Issuance”
means the issuance of (a) shares of Common Stock, restricted stock units or options, including the shares of Common Stock underlying
the restricted stock units or options, to consultants, employees, officers, directors or consultants of the Company or its subsidiary
pursuant to any stock or option plan or arrangement duly adopted for such purpose by a majority of the non-employee members of the Board
of Directors or a majority of the members of a committee of non-employee directors established for such purpose for services rendered
to the Company provided that such securities issued to consultants are issued as “restricted securities” (as defined in Rule 144)
and carry no registration rights that require or permit the filing of any registration statement in connection therewith during the prohibition
period in Section 4.11(a) herein, (b) securities upon the exercise or exchange of or conversion of any Securities issued
hereunder and/or other securities exercisable or exchangeable for or convertible into shares of Common Stock issued and outstanding on
the date of this Agreement, provided that such securities have not been amended since the date of this Agreement to increase
the number of such securities or to decrease the exercise price, exchange price or conversion price of such securities (other than in
connection with stock splits or combinations or anti-dilution provisions contained therein as disclosed in the SEC Reports and the Prospectus)
or to extend the term of such securities, (c) securities pursuant to merger, acquisition or strategic transactions approved by a
majority of the disinterested directors of the Company, provided that such securities are issued as “restricted
securities” (as defined in Rule 144) and carry no registration rights that require or permit the filing of any registration
statement in connection therewith during the prohibition period in Section 4.11(a) herein, and provided further that
any such issuance shall only be to a Person that is, itself or through its subsidiaries, an operating company in a business synergistic
with the business of the Company and in which the Company receives benefits in addition to any investment of funds, but shall not include
a transaction in which the Company is issuing securities primarily for the purpose of raising capital or to an entity whose primary business
is investing in securities, and (d) securities for settlement of outstanding payables or liabilities provided that
such securities are issued as “restricted securities” (as defined in Rule 144) and carry no registration rights that
require or permit the filing of any registration statement in connection therewith during the prohibition period in Section 4.11(a) herein.
“FCPA”
means the Foreign Corrupt Practices Act of 1977, as amended.
“GAAP”
means generally accepted accounting principles in the United States.
“General Disclosure
Package” means the Preliminary Prospectus, the Prospectus, and the Registration Statement.
“Indebtedness”
shall have the meaning ascribed to such term in Section 3.1(z).
“Intellectual Property
Rights” shall have the meaning ascribed to such term in Section 3.1(p).
“Liens”
means a lien, charge, pledge, security interest, encumbrance, right of first refusal, preemptive right or other restriction.
“Lock-Up Agreement”
means the Lock-Up Agreement, dated as of the date hereof, by and among the Company and the directors, officers and 5% stockholders of
the Company, in the form of Exhibit C attached hereto.
“Material Adverse
Effect” shall have the meaning assigned to such term in Section 3.1(b).
“Material Permits”
shall have the meaning ascribed to such term in Section 3.1(m).
“Per Share Purchase
Price” equals $[●], subject to adjustment for reverse and forward share splits, share dividends, share combinations and
other similar transactions of shares of Common Stock that occur between the date hereof and the Closing Date.
“Per Pre-Funded Warrant
Purchase Price” equals $0.0001, subject to adjustment for reverse and forward share splits, share dividends, share combinations
and other similar transactions relating to shares of Common Stock that occur after the date of this Agreement.
“Person”
means an individual or corporation, partnership, trust, incorporated or unincorporated association, joint venture, limited liability company,
joint stock company, government (or an agency or subdivision thereof) or other entity of any kind.
“Placement Agent”
means A.G.P./Alliance Global Partners.
“Placement Agent
Counsel” means Thompson Hine LLP with offices located at 300 Madison Ave, 27th Floor, New York, New York 10017.
“Pre-Funded Warrants”
means, collectively, the warrants delivered to the Purchasers at Closing in accordance with Section 2.2(a) hereof, which Pre-Funded
Warrants shall be exercisable immediately upon issuance and shall expire when exercised in full, in the form of Exhibit B
attached hereto.
“Pre-Notice”
shall have the meaning ascribed to such term in Section 4.16(b).
“Preliminary Prospectus”
means the preliminary prospectus included in the Registration Statement at the time the Registration Statement is declared effective.
“Proceeding”
means an action, claim, suit, investigation or proceeding (including, without limitation, an informal investigation or partial proceeding,
such as a deposition), whether commenced or threatened.
“Prospectus”
means the final prospectus filed pursuant to the Registration Statement.
“Purchaser Party”
shall have the meaning ascribed to such term in Section 4.8.
“Registration Statement”
means the effective registration statement with the Commission on Form S-1 (File No. 333-[●]), as amended, which registers
the sale of the Securities and includes any Rule 462(b) Registration Statement.
“Required Approvals”
shall have the meaning ascribed to such term in Section 3.1(e).
“Rule 144”
means Rule 144 promulgated by the Commission pursuant to the Securities Act, as such Rule may be amended or interpreted from
time to time, or any similar rule or regulation hereafter adopted by the Commission having substantially the same purpose and effect
as such Rule.
“Rule 424”
means Rule 424 promulgated by the Commission pursuant to the Securities Act, as such Rule may be amended or interpreted from
time to time, or any similar rule or regulation hereafter adopted by the Commission having substantially the same purpose and effect
as such Rule.
“Rule 462(b) Registration
Statement” means any registration statement prepared by the Company registering additional Securities, which was filed with
the Commission on or prior to the date hereof and became automatically effective pursuant to Rule 462(b) promulgated by the
Commission pursuant to the Securities Act.
“SEC Reports”
shall have the meaning ascribed to such term in Section 3.1(h).
“Securities”
means the Shares, the Warrants, and the Warrant Shares.
“Securities Act”
means the Securities Act of 1933, as amended, and the rules and regulations promulgated thereunder.
“Shares”
means the shares of Common Stock issued and issuable to each Purchaser pursuant to this Agreement.
“Short Sales”
means all “short sales” as defined in Rule 200 of Regulation SHO under the Exchange Act (but shall not be deemed to include
locating and/or borrowing shares of Common Stock).
“Subscription Amount”
means, as to each Purchaser, the aggregate amount to be paid for shares of Common Stock, and Pre-Funded Warrants, purchased hereunder
as specified below such Purchaser’s name on the signature page of this Agreement and next to the heading “Subscription
Amount,” in United States dollars and in immediately available funds.
“Subsidiary”
means any significant subsidiary of the Company as set forth in the Exhibit 21.1 to the Company’s Annual Report on Form 10-K
for the year ended December 31, 2023 and shall, where applicable, also include any direct or indirect subsidiary of the Company formed
or acquired after the date hereof.
“Trading Day”
means a day on which the principal Trading Market is open for trading.
“Trading Market”
means any of the following markets or exchanges on which the shares of Common Stock are listed or quoted for trading on the date in question:
the NYSE American, The Nasdaq Capital Market, The Nasdaq Global Market, The Nasdaq Global Select Market, or the New York Stock Exchange
(or any successors to any of the foregoing).
“Transaction Documents”
means this Agreement, the Warrants, the Lock-Up Agreements and all exhibits and schedules thereto and hereto and any other documents or
agreements executed in connection with the transactions contemplated hereunder.
“Variable Rate Transaction”
shall have the meaning ascribed to such term in Section 4.10(b).
“Warrants”
means, collectively, the Common Warrants and the Pre-Funded Warrants.
“Warrant Shares”
means, collectively, the shares of Common Stock issuable upon exercise of the Warrants.
Section 2.
PURCHASE AND SALE
2.1 Closing. On the Closing Date, upon
the terms and subject to the conditions set forth herein, the Company agrees to sell, and the Purchasers, severally and not jointly, agree
to purchase, (i) the number of shares of Common Stock set forth under the heading “Subscription Amount” on the Purchaser’s
signature page hereto, at the Per Share Purchase Price, and (ii) Common Warrants exercisable for shares of Common Stock as calculated
pursuant to Section 2.2(a); provided, however, that, to the extent that a Purchaser determines, in its sole discretion, that
such Purchaser (together with such Purchaser’s Affiliates, and any Person acting as a group together with such Purchaser or any
of such Purchaser’s Affiliates) would beneficially own in excess of the Beneficial Ownership Limitation, or as such Purchaser may
otherwise choose, in lieu of purchasing shares of Common Stock, such Purchaser may elect to purchase Pre-Funded Warrants in such manner
to result in the full Subscription Amount being paid by such Purchaser to the Company. The “Beneficial Ownership Limitation”
shall be 4.99% (or, at the election of the Purchaser, 9.99%) of the number of shares of Common Stock, in each case, outstanding immediately
after giving effect to the issuance of the Securities on the Closing Date.
Each Purchaser’s Subscription
Amount as set forth on the signature page hereto executed by such Purchaser shall be made available for Delivery Versus Payment (“DVP”)
settlement with the Company or its designees. The Company shall deliver to each Purchaser its respective Shares and Warrants as determined
pursuant to Section 2.2(a), and the Company and each Purchaser shall deliver the other items set forth in Section 2.2 at the
Closing. Upon satisfaction of the covenants and conditions set forth in Sections 2.2 and 2.3, the Closing shall occur remotely via the
exchange of documents and signatures or such other location as the parties shall mutually agree. Unless otherwise directed by the Placement
Agent, settlement of the Shares shall occur via DVP (i.e., on the Closing Date, the Company shall issue the Shares registered in the Purchasers’
names and addresses and released by the Depositary directly to the account(s) at the Placement Agent identified by each Purchaser;
upon receipt of such Shares, the Placement Agent shall promptly electronically deliver such Shares to the applicable Purchaser, and payment
therefor shall be made by the Placement Agent (or its clearing firm) by wire transfer to the Company). Notwithstanding anything herein
to the contrary, if at any time on or after the time of execution of this Agreement by the Company and an applicable Purchaser through,
and including the time immediately prior to the Closing (the “Pre-Settlement Period”), such Purchaser sells to any
Person all, or any portion, of any Securities to be issued hereunder to such Purchaser at the Closing (collectively, the “Pre-Settlement
Shares”), such Person shall, automatically hereunder (without any additional required actions by such Purchaser or the Company),
be deemed to be a Purchaser under this Agreement unconditionally bound to purchase, and the Company shall be deemed unconditionally bound
to sell, such Pre-Settlement Shares to such Person at the Closing; provided, that the Company shall not be required to deliver any Pre-Settlement
Shares to such Purchaser prior to the Company’s receipt of the Subscription Amount for such Pre-Settlement Shares hereunder; and
provided, further, that the Company hereby acknowledges and agrees that the forgoing shall not constitute a representation or covenant
by such Purchaser as to whether or not such Purchaser will elect to sell any Pre-Settlement Shares during the Pre-Settlement Period. The
decision to sell any shares of Common Stock by such Purchaser shall solely be made at the time such Purchaser elects to effect any such
sale, if any. Notwithstanding the foregoing, with respect to any Notice(s) of Exercise (as defined in the Prefunded Warrants) delivered
on or prior to 9:00 a.m. (New York City time) on the Closing Date, which may be delivered at any time after the time of execution
of the this Agreement, the Company agrees to deliver the Warrant Shares subject to such notice(s) by 4:00 p.m. (New York City
time) on the Closing Date and the Closing Date shall be the Warrant Share Delivery Date (as defined in the Prefunded Warrants) for purposes
hereunder.
2.2 Deliveries.
|
(a) |
On or prior to the Closing Date, the Company shall deliver or cause to be delivered to each Purchaser the following: |
|
(i) |
this Agreement duly executed by the Company; |
|
(ii) |
the Company’s wire instructions, on Company letterhead and executed by the Company’s Chief Executive Officer or Chief Financial Officer; |
|
(iii) |
subject to the provision of Section 2.1 that settlement of the Shares shall occur via DVP, a copy of the irrevocable instructions to the Transfer Agent instructing the Transfer Agent to deliver on an expedited basis via The Depository Trust Company Deposit or Withdrawal at Custodian system shares of Common Stock equal to the portion of such Purchaser’s Subscription Amount divided by the Per Share Purchase Price, registered in the name of such Purchaser; |
|
(iv) |
for each Purchaser of Pre-Funded Warrants pursuant to Section 2.1, a Pre-Funded Warrant registered in the name of such Purchaser to purchase up to a number of shares of Common Stock equal to the portion of such Purchaser’s Subscription Amount applicable to Pre-Funded Warrants divided by the sum of the Per Pre-Funded Warrant Purchase Price, subject to adjustment therein; |
|
(v) |
the Preliminary Prospectus and the Prospectus (which may be delivered in accordance with Rule 172 under the Securities Act); |
|
(vi) |
a Common Warrant with an exercise price equal to $[●], registered in the name of such Purchaser, to purchase up to a number of shares of Common Stock equal to 100% of such Purchaser’s shares of Common Stock, or a Pre-Funded Warrants, as applicable, with an exercise price equal to $0.0001 per share, subject to adjustment therein; |
|
(vii) |
the duly executed Lock-Up Agreements; |
|
(viii) |
a legal opinion of Company Counsel, in form reasonably acceptable to the Placement Agent and the Purchasers; and |
|
(ix) |
a legal opinion of Company Nevada Counsel, in form reasonably acceptable to the Placement Agent and the Purchasers. |
|
(b) |
On or prior to the Closing Date, each Purchaser shall deliver or cause to be delivered to the Company, the following: |
|
(i) |
this Agreement duly executed by such Purchaser; and |
|
(ii) |
such Purchaser’s Subscription Amount with respect to the Securities purchased by such Purchaser, which shall be made available for DVP settlement with the Company or its designees. |
2.3 Closing Conditions.
|
(a) |
The obligations of the Company hereunder in connection with the Closing are subject to the following conditions being met: |
|
(i) |
the accuracy in all material respects (or, to the extent representations or warranties are qualified by materiality or Material Adverse Effect, in all respects) when made and on the Closing Date of the representations and warranties of the Purchasers contained herein (unless as of a specific date therein in which case they shall be accurate as of such date in all material respects or to the extent qualified by materiality or Material Adverse Effect); |
|
(ii) |
all obligations, covenants and agreements of each Purchaser required to be performed at or prior to the Closing Date shall have been performed; and |
|
(iii) |
the delivery by each Purchaser of the items set forth in Section 2.2(b) of this Agreement. |
|
(b) |
The respective obligations of the Purchasers hereunder in connection with the Closing are subject to the following conditions being met: |
|
(i) |
the accuracy in all material respects (or, to the extent representations or warranties are qualified by materiality or Material Adverse Effect, in all respects) when made and on the Closing Date of the representations and warranties of the Company contained herein (unless as of a specific date therein in which case they shall be accurate as of such date); |
|
(ii) |
all obligations, covenants and agreements of the Company required to be performed at or prior to the Closing Date shall have been performed; |
|
(iii) |
the delivery by the Company of the items set forth in Section 2.2(a) of this Agreement; |
|
(iv) |
there shall have been no Material Adverse Effect with respect to the Company since the date hereof; and |
|
(v) |
from the date hereof to the Closing Date, trading in the Common Stock shall not have been suspended by the Commission or any Trading Market, and, at any time prior to the Closing Date, trading in securities generally as reported by Bloomberg L.P. shall not have been suspended or limited, nor shall a banking moratorium have been declared either by the United States or New York State authorities nor shall there have occurred after the date of this Agreement any material outbreak or escalation of hostilities or other national or international calamity of such magnitude in its effect on, or any material adverse change in, any financial market which, in each case, in the reasonable judgment of such Purchaser, makes it impracticable or inadvisable to purchase the Securities at the Closing. |
Section 3.
REPRESENTATIONS AND WARRANTIES
3.1 Representations and Warranties of the Company.
Except as set forth in the Disclosure Schedules, which Disclosure Schedules shall be deemed a part hereof and shall qualify any representation
or otherwise made herein to the extent of the disclosure contained in the corresponding section of the Disclosure Schedules, the Company
hereby makes the following representations and warranties to each Purchaser:
|
(a) |
Subsidiaries. Except as disclosed in the SEC Reports, the Company owns, directly or indirectly, all of the capital shares or other equity interests of each Subsidiary, free and clear of any Liens, and all of the issued and outstanding shares of capital stock of each Subsidiary are validly issued and are fully paid, non-assessable and free of preemptive and similar rights to subscribe for or purchase securities. |
|
(b) |
Organization and Qualification. The Company and each of the Subsidiaries is an entity duly incorporated or otherwise organized, validly existing, and, if applicable under the laws of the jurisdiction in which they are formed, in good standing under the laws of the jurisdiction of its incorporation or organization, with the requisite power and authority to own and use its properties and assets and to carry on its business as currently conducted. Neither the Company nor any Subsidiary is in violation nor default of any of the provisions of its respective memorandum of association, articles of association, certificate or articles of incorporation, bylaws, operating agreement, or other organizational or charter documents that would constitute a Material Adverse Effect (defined below). Each of the Company and the Subsidiaries is duly qualified to conduct business and is in good standing (where applicable) as a foreign corporation or other entity in each jurisdiction in which the nature of the business conducted or property owned by it makes such qualification necessary, except where the failure to be so qualified or in good standing, as the case may be, could not have or reasonably be expected to result in: (i) a material adverse effect on the legality, validity or enforceability of any Transaction Document, (ii) material adverse effect on the results of operations, assets, business, prospects or condition (financial or otherwise) of the Company and the Subsidiaries, taken as a whole, or (iii) a material adverse effect on the Company’s ability to perform in any material respect on a timely basis its obligations under any Transaction Document (any of (i), (ii) or (iii), a “Material Adverse Effect”) and no Proceeding has been instituted in any such jurisdiction revoking, limiting or curtailing or seeking to revoke, limit or curtail such power and authority or qualification. |
|
(c) |
Authorization; Enforcement. The Company has the requisite corporate power and authority to enter into and to consummate the transactions contemplated by this Agreement and each of the other Transaction Documents and otherwise to carry out its obligations hereunder and thereunder. The execution and delivery of this Agreement and each of the other Transaction Documents by the Company and the consummation by it of the transactions contemplated hereby and thereby have been duly authorized by all necessary action on the part of the Company and no further action is required by the Company, the Board of Directors, a committee of the Board of Directors or the Company’s stockholders in connection herewith or therewith other than in connection with the Required Approvals. This Agreement and each other Transaction Document to which it is a party has been (or upon delivery will have been) duly executed by the Company and, when delivered in accordance with the terms hereof and thereof, will constitute the valid and binding obligation of the Company enforceable against the Company in accordance with its terms, except (i) as limited by general equitable principles and applicable bankruptcy, insolvency, reorganization, moratorium and other laws of general application affecting enforcement of creditors’ rights generally, (ii) as limited by laws relating to the availability of specific performance, injunctive relief or other equitable remedies and (iii) insofar as indemnification and contribution provisions may be limited by applicable law. |
|
(d) |
No Conflicts. The execution, delivery and performance by the Company of this Agreement and the other Transaction Documents to which it is a party, the issuance and sale of the Securities and the consummation by it of the transactions contemplated hereby and thereby do not and will not (i) conflict with or violate any provision of the Company’s or any Subsidiary’s memorandum of association, articles of association, certificate or articles of incorporation, bylaws, operating agreement, or other organizational or charter documents, or (ii) conflict with, or constitute a default (or an event that with notice or lapse of time or both would become a default) under, result in the creation of any Lien upon any of the properties or assets of the Company or any Subsidiary, or give to others any rights of termination, amendment, anti-dilution or similar adjustments acceleration or cancellation (with or without notice, lapse of time or both) of, any agreement, credit facility, debt or other instrument (evidencing a Company or Subsidiary debt or otherwise) or other understanding to which the Company or any Subsidiary is a party or by which any property or asset of the Company or any Subsidiary is bound or affected, or (iii) subject to the Required Approvals, conflict with or result in a violation of any law, rule, regulation, order, judgment, injunction, decree or other restriction of any court or governmental authority to which the Company or a Subsidiary is subject (including federal and state securities laws and regulations), or by which any property or asset of the Company or a Subsidiary is bound or affected; except in the case of each of clauses (ii) and (iii), such as could not have or reasonably be expected to result in a Material Adverse Effect. |
|
(e) |
Filings, Consents and Approvals. The Company is not required to obtain any consent, waiver, authorization or order of, give any notice to, or make any filing or registration with, any court or other federal, state, local or other governmental authority or other Person in connection with the execution, delivery and performance by the Company of the Transaction Documents, other than: (i) the filings required pursuant to Section 4.4 of this Agreement, (ii) the filing with the Commission of the Prospectus, (iii) notices and/or application(s) to and approvals by each applicable Trading Market for the listing of the applicable Securities for trading thereon in the time and manner required thereby, and (iv) filings required by the Financial Industry Regulatory Authority (“FINRA”) (collectively, the “Required Approvals”). |
|
(f) |
Issuance of the Securities; Registration. The Shares and Warrant Shares are duly authorized and, when issued and paid for in accordance with the applicable Transaction Documents, will be duly and validly issued, fully paid and non-assessable, free and clear of all Liens imposed by the Company. The Warrants are duly authorized and binding obligations of the Company under the law of the jurisdiction governing the Warrants, and, when issued in accordance with this Agreement, will be duly and validly issued, and free and clear of all Liens imposed by the Company. The Company has reserved from its duly authorized share capital the maximum number of shares of Common Stock issuable pursuant to this Agreement and the Warrants. The Company has prepared and filed the Registration Statement in conformity with the requirements of the Securities Act, which became effective on [●], 2025, including the Prospectus, and such amendments and supplements thereto as may have been required to the date of this Agreement. The Registration Statement is effective under the Securities Act and no stop order preventing or suspending the effectiveness of the Registration Statement or suspending or preventing the use of the Preliminary Prospectus or the Prospectus has been issued by the Commission and no proceedings for that purpose have been instituted or, to the knowledge of the Company, are threatened by the Commission. The Company, if required by the rules and regulations of the Commission, shall file the Preliminary Prospectus or the Prospectus with the Commission pursuant to Rule 424(b). At the time the Registration Statement and any amendments thereto became effective as determined under the Securities Act, at the date of this Agreement and at the Closing Date, the Registration Statement and any amendments thereto conformed and will conform in all material respects to the requirements of the Securities Act and did not and will not contain any untrue statement of a material fact or omit to state any material fact required to be stated therein or necessary to make the statements therein not misleading; and the Prospectus and any amendments or supplements thereto, at the time the Preliminary Prospectus, the Prospectus or any amendment or supplement thereto was issued and at the Closing Date, conformed and will conform in all material respects to the requirements of the Securities Act and did not and will not contain an untrue statement of a material fact or omit to state a material fact necessary in order to make the statements therein, in the light of the circumstances under which they were made, not misleading. |
|
(g) |
Capitalization. The capitalization of the Company as of the date hereof is as set forth in the General Disclosure Package, and includes the number of shares of Common Stock owned beneficially, and of record, by Affiliates of the Company as of the date hereof. The Company has not issued any capital stock since its most recently filed report under the Exchange Act, other than pursuant to the exercise of employee stock options under the Company’s stock option plans, the issuance of shares of Common Stock to employees pursuant to the Company’s employee stock purchase plans and pursuant to the conversion and/or exercise of Common Stock Equivalents outstanding as of the date of the most recently filed report under the Exchange Act. No Person has any right of first refusal, preemptive right, right of participation, or any similar right to participate in the transactions contemplated by the Transaction Documents. As a result of the purchase and sale of the Securities, there are no outstanding options, warrants, scrip rights to subscribe to, calls or commitments of any character whatsoever relating to, or securities, rights or obligations convertible into or exercisable or exchangeable for, or giving any Person any right to subscribe for or acquire, any shares of Common Stock, or contracts, commitments, understandings or arrangements by which the Company or any Subsidiary is or may become bound to issue additional shares of Common Stock or Common Stock Equivalents. The issuance and sale of the Securities will not result in a right of any holder of Company securities to adjust the exercise, conversion, exchange or reset price under any of such securities. There are no outstanding securities or instruments of the Company or any Subsidiary with any provision that adjusts the exercise, conversion, exchange or reset price of such security or instrument upon an issuance of securities by the Company or any Subsidiary. There are no outstanding securities or instruments of the Company or any Subsidiary that contain any redemption or similar provisions, and there are no contracts, commitments, understandings or arrangements by which the Company or any Subsidiary is or may become bound to redeem a security of the Company or such Subsidiary. The Company does not have any share appreciation rights or “phantom share” plans or agreements or any similar plan or agreement. All of the outstanding shares of the Company are duly authorized, validly issued, fully paid and non-assessable, have been issued in compliance with all federal and state securities laws where applicable, and none of such outstanding shares was issued in violation of any preemptive rights or similar rights to subscribe for or purchase securities. Except for the Required Approvals, no further approval or authorization of any stockholder, the Board of Directors, or others is required for the issuance and sale of the Securities. There are no stockholders agreements, voting agreements or other similar agreements with respect to the Company’s share capital to which the Company is a party or, to the knowledge of the Company, between or among any of the Company’s stockholders. |
|
(h) |
SEC Reports; Financial Statements. The Company has filed all reports, schedules, forms, statements and other documents required to be filed by the Company under the Securities Act and the Exchange Act, including pursuant to Section 13(a) or 15(d) thereof, for the one year preceding the date hereof (or such shorter period as the Company was required by law or regulation to file such materials) (the foregoing materials, including the exhibits thereto and documents incorporated by reference therein, together with the Preliminary Prospectus and the Prospectus, being collectively referred to herein as the “SEC Reports”) As of their respective dates, the SEC Reports complied in all material respects with the requirements of the Securities Act and the Exchange Act, as applicable, and none of the SEC Reports, when filed, contained any untrue statement of a material fact or omitted to state a material fact required to be stated therein or necessary in order to make the statements therein, in the light of the circumstances under which they were made, not misleading. The financial statements of the Company included in the SEC Reports comply in all material respects with applicable accounting requirements and the rules and regulations of the Commission with respect thereto as in effect at the time of filing. Such financial statements have been prepared in accordance with GAAP, except as may be otherwise specified in such financial statements or the notes thereto and except that unaudited financial statements may not contain all footnotes required by GAAP, and fairly present in all material respects the financial position of the Company and its consolidated Subsidiaries as of and for the dates thereof and the results of operations and cash flows for the periods then ended, subject, in the case of unaudited statements, to normal, immaterial, year-end audit adjustments. |
|
(i) |
Material Changes; Undisclosed Events, Liabilities or Developments. Since the date of the latest financial statements filed by the Company with the SEC and other than the reverse stock split effected August 26, 2024, (i) there has been no event, occurrence or development that has had or that could reasonably be expected to result in a Material Adverse Effect, (ii) the Company has not incurred any liabilities (contingent or otherwise) other than (A) trade payables and accrued expenses incurred in the ordinary course of business consistent with past practice and strategic acquisitions and (B) liabilities not required to be reflected in the Company’s financial statements pursuant to GAAP or disclosed in filings made with the Commission, (iii) the Company has not altered its method of accounting, (iv) the Company has not declared or made any dividend or distribution of cash or other property to its stockholders or purchased, redeemed or made any agreements to purchase or redeem any of its shares and (v) the Company has not issued any equity securities to any officer, director or Affiliate, except pursuant to existing Company equity incentive plans. The Company does not have pending before the Commission any request for confidential treatment of information. Except for the issuance of the Securities contemplated by this Agreement, no event, liability, fact, circumstance, occurrence or development has occurred or exists or is reasonably expected to occur or exist with respect to the Company or its Subsidiaries or their respective businesses, prospects, properties, operations, assets or financial condition that would be required to be disclosed by the Company under applicable securities laws at the time this representation is made or deemed made that has not been publicly disclosed at least one (1) Trading Day prior to the date that this representation is made. |
|
(j) |
Litigation. There is no action, suit, inquiry, notice of violation, proceeding or investigation pending or, to the knowledge of the Company, threatened against or affecting the Company, any Subsidiary or any of their respective properties before or by any court, arbitrator, governmental or administrative agency or regulatory authority (federal, state, county, local or foreign) (collectively, an “Action”) except as disclosed in the General Disclosure Package. None of the Actions disclosed in the General Disclosure Package (i) adversely affects or challenges the legality, validity or enforceability of any of the Transaction Documents, the Shares or the Warrant Shares, or (ii) could, if there were an unfavorable decision, have or reasonably be expected to result in a Material Adverse Effect. Neither the Company nor any Subsidiary, nor any director or officer thereof, is or has been the subject of any Action involving a claim of violation of or liability under federal or state securities laws or a claim of breach of fiduciary duty, which could result in a Material Adverse Effect. There has not been, and to the knowledge of the Company, there is not pending or contemplated, any investigation by the Commission involving the Company or any current or former director or officer of the Company. The Commission has not issued any stop order or other order suspending the effectiveness of any registration statement filed by the Company or any Subsidiary under the Exchange Act or the Securities Act. |
|
(k) |
Labor Relations. No labor dispute exists or, to the knowledge of the Company, is imminent with respect to any of the employees of the Company, which could reasonably be expected to result in a Material Adverse Effect. None of the Company’s or its Subsidiaries’ employees is a member of a union that relates to such employee’s relationship with the Company or such Subsidiary, and neither the Company nor any of its Subsidiaries is a party to a collective bargaining agreement, and the Company and its Subsidiaries believe that their relationships with their employees are good. To the knowledge of the Company, no executive officer of the Company or any Subsidiary, is, or is now expected to be, in violation of any material term of any employment contract, confidentiality, disclosure or proprietary information agreement or non-competition agreement, or any other contract or agreement or any restrictive covenant in favor of any third party, and the continued employment of each such executive officer does not subject the Company or any of its Subsidiaries to any liability with respect to any of the foregoing matters. The Company and its Subsidiaries are in compliance with all applicable U.S. federal, state, local and foreign laws and regulations relating to employment and employment practices, terms and conditions of employment and wages and hours, except where the failure to be in compliance could not, individually or in the aggregate, reasonably be expected to have a Material Adverse Effect. |
|
(l) |
Compliance. Neither the Company nor any Subsidiary: (i) is in default under or in violation of (and no event has occurred that has not been waived that, with notice or lapse of time or both, would result in a default by the Company or any Subsidiary under), nor has the Company or any Subsidiary received notice of a claim that it is in default under or that it is in violation of, any indenture, loan or credit agreement or any other agreement or instrument to which it is a party or by which it or any of its properties is bound (whether or not such default or violation has been waived), (ii) is in violation of any judgment, decree or order of any court, arbitrator or other governmental authority or (iii) is or has been in violation of any statute, rule, ordinance or regulation of any governmental authority, including without limitation all foreign, federal, state and local laws relating to taxes, environmental protection, occupational health and safety, product quality and safety and employment and labor matters, except in each case of (i), (ii) and (iii) as could not have or reasonably be expected to result in a Material Adverse Effect. |
|
(m) |
Environmental Laws. The Company and its Subsidiaries (i) are in compliance with all federal, state, local and foreign laws relating to pollution or protection of human health or the environment (including ambient air, surface water, groundwater, land surface or subsurface strata), including laws relating to emissions, discharges, releases or threatened releases of chemicals, pollutants, contaminants, or toxic or hazardous substances or wastes (collectively, “Hazardous Materials”) into the environment, or otherwise relating to the manufacture, processing, distribution, use, treatment, storage, disposal, transport or handling of Hazardous Materials, as well as all authorizations, codes, decrees, demands, or demand letters, injunctions, judgments, licenses, notices or notice letters, orders, permits, plans or regulations, issued, entered, promulgated or approved thereunder (“Environmental Laws”); (ii) have received all permits licenses or other approvals required of them under applicable Environmental Laws to conduct their respective businesses; and (iii) are in compliance with all terms and conditions of any such permit, license or approval where in each clause (i), (ii) and (iii), the failure to so comply could be reasonably expected to have, individually or in the aggregate, a Material Adverse Effect. |
|
(n) |
Regulatory Permits. The Company and the Subsidiaries possess all certificates, authorizations and permits issued by the appropriate federal, state, local or foreign regulatory authorities necessary to conduct their respective businesses as described in the General Disclosure Package, except where the failure to possess such certificates, authorizations or permits could not reasonably be expected to result in a Material Adverse Effect (“Material Permits”), and neither the Company nor any Subsidiary has received any notice of proceedings relating to the revocation or modification of any Material Permit. |
|
(o) |
Title to Assets. Except as disclosed in the General Disclosure Package, the Company and the Subsidiaries have good and marketable title in fee simple to all real property owned by them and good and marketable title in all personal property owned by them that is material to the business of the Company and the Subsidiaries, in each case free and clear of all Liens, except for (i) Liens as do not materially affect the value of such property and do not materially interfere with the use made and proposed to be made of such property by the Company and the Subsidiaries and (ii) Liens for the payment of federal, state or other taxes, for which appropriate reserves have been made therefor in accordance with GAAP and, the payment of which is neither delinquent nor subject to penalties. Any real property and facilities held under lease by the Company and the Subsidiaries are held by them under valid, subsisting and enforceable leases with which the Company and the Subsidiaries are in compliance in all material respects. |
|
(p) |
Intellectual Property. The Company and the Subsidiaries have, or have rights to use, all patents, patent applications, trademarks, trademark applications, service marks, trade names, trade secrets, inventions, copyrights, licenses and other intellectual property rights and similar rights necessary or required for use in connection with their respective businesses as described in the General Disclosure Package, and which the failure to so have could have a Material Adverse Effect (collectively, the “Intellectual Property Rights”). None of, and neither the Company nor any Subsidiary has received a notice (written or otherwise) that any of, the Intellectual Property Rights has expired, terminated or been abandoned, or is expected to expire or terminate or be abandoned, within two (2) years from the date of this Agreement except as would not reasonably be expected to have a Material Adverse Effect. Neither the Company nor any Subsidiary has received, since the date of the latest audited financial statements included within the General Disclosure Package, a written notice of a claim or otherwise has any knowledge that the Intellectual Property Rights violate or infringe upon the rights of any Person, except as could not have or reasonably be expected to not have a Material Adverse Effect. To the actual knowledge of the Company, all such Intellectual Property Rights are enforceable and there is no existing infringement by another Person of any of the Intellectual Property Rights. The Company and its Subsidiaries have taken reasonable security measures to protect the secrecy, confidentiality and value of all of their intellectual properties, except where failure to do so could not, individually or in the aggregate, reasonably be expected to have a Material Adverse Effect. |
|
(q) |
Insurance. The Company and the Subsidiaries are insured by insurers of recognized financial responsibility against such losses and risks and in such amounts as are prudent and customary in the businesses in which the Company and the Subsidiaries are engaged, including, but not limited to, directors and officers insurance coverage in an amount deemed commercially reasonable. Neither the Company nor any Subsidiary has any reason to believe that it will not be able to renew its existing insurance coverage as and when such coverage expires or to obtain similar coverage from similar insurers as may be necessary to continue its business without a significant increase in cost. |
|
(r) |
Transactions with Affiliates and Employees. Except as set forth in the General Disclosure Package, none of the officers or directors of the Company or any Subsidiary and, to the knowledge of the Company, none of the employees of the Company or any Subsidiary is presently a party to any transaction with the Company or any Subsidiary (other than for services as employees, officers and directors), including any contract, agreement or other arrangement providing for the furnishing of services to or by, providing for rental of real or personal property to or from, providing for the borrowing of money from or lending of money to or otherwise requiring payments to or from any officer, director or such employee or, to the knowledge of the Company, any entity in which any officer, director, or any such employee has a substantial interest or is an officer, director, trustee, shareholder, member or partner, in each case in excess of $120,000 other than for (i) payment of salary or consulting fees for services rendered, (ii) reimbursement for expenses incurred on behalf of the Company or a Subsidiary and (iii) other employee benefits, including share option agreements under any share option plan of the Company. |
|
(s) |
Sarbanes-Oxley; Internal Accounting Controls. Except as set forth in the SEC Reports, the Company and the Subsidiaries are in material compliance with any and all applicable requirements of the Sarbanes-Oxley Act of 2002 that are effective as of the date hereof, and any and all applicable rules and regulations promulgated by the Commission thereunder that are effective as of the date hereof and as of the Closing Date. Except as set forth in the SEC Reports, the Company and the Subsidiaries maintain a system of internal accounting controls sufficient to provide reasonable assurance that: (i) transactions are executed in accordance with management’s general or specific authorizations, (ii) transactions are recorded as necessary to permit preparation of financial statements in conformity with GAAP and to maintain asset accountability, (iii) access to assets is permitted only in accordance with management’s general or specific authorization, and (iv) the recorded accountability for assets is compared with the existing assets at reasonable intervals and appropriate action is taken with respect to any differences. The Company and the Subsidiaries have established disclosure controls and procedures (as defined in Exchange Act Rules 13a-15(e) and 15d-15(e)) for the Company and the Subsidiaries and designed such disclosure controls and procedures to ensure that information required to be disclosed by the Company in the reports it files or submits under the Exchange Act is recorded, processed, summarized and reported, within the time periods specified in the Commission’s rules and forms. The Company’s certifying officers have evaluated the effectiveness of the disclosure controls and procedures of the Company and the Subsidiaries as of the end of the period covered by the most recently filed Form 10-Q under the Exchange Act (such date, the “Evaluation Date”). The Company presented in its most recently filed Form 10-Q under the Exchange Act the conclusions of the certifying officers about the effectiveness of the disclosure controls and procedures based on their evaluations as of the Evaluation Date. Since the Evaluation Date, there have been no changes in the internal control over financial reporting (as such term is defined in the Exchange Act) that have materially affected, or is reasonably likely to materially affect, the internal control over financial reporting of the Company and its Subsidiaries. |
|
(t) |
Certain Fees. Except for fees payable to the Placement Agent, no brokerage or finder’s fees or commissions are or will be payable by the Company or any Subsidiary to any broker, financial advisor or consultant, finder, placement agent, investment banker, bank or other Person with respect to the transactions contemplated by the Transaction Documents (for the avoidance of doubt, the foregoing shall not include any fees and/or commissions owed to the Depositary). Other than for Persons engaged by any Purchaser, if any, the Purchasers shall have no obligation with respect to any fees or with respect to any claims made by or on behalf of other Persons for fees of a type contemplated in this Section that may be due in connection with the transactions contemplated by the Transaction Documents. |
|
(u) |
Investment Company. The Company is not, and is not an Affiliate of, and immediately after receipt of payment for the Securities, will not be or be an Affiliate of, an “investment company” within the meaning of the Investment Company Act of 1940, as amended. The Company shall conduct its business in a manner so that it will not become an “investment company” subject to registration under the Investment Company Act of 1940, as amended. |
|
(v) |
Registration Rights. No Person has any right to cause the Company to effect the registration under the Securities Act of any securities of the Company or any Subsidiary. |
|
(w) |
Listing and Maintenance Requirements. The shares of Common Stock are registered pursuant to Section 12(b) or 12(g) of the Exchange Act, and the Company has taken no action designed to, or which to its knowledge is likely to have the effect of, terminating the registration of the Common Stock under the Exchange Act nor has the Company received any notification that the Commission is contemplating terminating such registration. Except as disclosed in the General Disclosure Package, the Company has not, in the 12 months preceding the date hereof, received notice from any Trading Market on which the Common Stock are or have been listed or quoted to the effect that the Company is not in compliance with the listing or maintenance requirements of such Trading Market. The shares of Common Stock are currently eligible for electronic transfer through The Depository Trust Company or another established clearing corporation and the Company is current in payment of the fees to The Depository Trust Company (or such other established clearing corporation) in connection with such electronic transfer. |
|
(x) |
Application of Takeover Protections. The Company and the Board of Directors have taken all necessary action, if any, in order to render inapplicable any control share acquisition, business combination, poison pill (including any distribution under a rights agreement) or other similar anti-takeover provision under the Company’s articles of incorporation or the laws of its state of incorporation that is or could become applicable to the Purchasers as a result of the Purchasers and the Company fulfilling their obligations or exercising their rights under the Transaction Documents, including without limitation as a result of the Company’s issuance of the Securities and the Purchasers’ ownership of the Securities. |
|
(y) |
Disclosure. Except with respect to the material terms and conditions of the transactions contemplated by the Transaction Documents, the Company confirms that it has not provided any of the Purchasers or their agents or counsel with any information that it believes constitutes or might constitute material, non-public information which is not otherwise disclosed in the Prospectus. The Company understands and confirms that the Purchasers will rely on the foregoing representation in effecting transactions in securities of the Company. All of the disclosure furnished by or on behalf of the Company to the Purchasers regarding the Company and its Subsidiaries, their respective businesses and the transactions contemplated hereby, including the Disclosure Schedules to this Agreement, is true and correct in all material respects and does not contain any untrue statement of a material fact or omit to state any material fact necessary in order to make the statements made therein, in the light of the circumstances under which they were made, not misleading. The press releases disseminated by the Company during the twelve months preceding the date of this Agreement taken as a whole do not contain any untrue statement of a material fact or omit to state a material fact required to be stated therein or necessary in order to make the statements therein, in the light of the circumstances under which they were made and when made, not misleading. The Company acknowledges and believes, to its best knowledge, that no Purchaser makes or has made any representations or warranties with respect to the transactions contemplated hereby other than those specifically set forth in Section 3.2 hereof. |
|
(z) |
No Integrated Offering. Assuming the accuracy of the Purchasers’ representations and warranties set forth in Section 3.2, neither the Company, nor any of its Affiliates, nor any Person acting on its or their behalf has, directly or indirectly, made any offers or sales of any security or solicited any offers to buy any security, under circumstances that would cause this offering of the Securities to be integrated with prior offerings by the Company for purposes of any applicable stockholder approval provisions of any Trading Market on which any of the securities of the Company are listed or designated. |
|
(aa) |
Solvency. Except as disclosed in the General Disclosure Package, based on the consolidated financial condition of the Company as of the Closing Date, after giving effect to the receipt by the Company of the proceeds from the sale of the Securities hereunder, (i) the fair saleable value of the Company’s assets exceeds the amount that will be required to be paid on or in respect of the Company’s existing debts and other liabilities (including known contingent liabilities) as they mature, (ii) the Company’s assets do not constitute unreasonably small capital to carry on its business as now conducted and as proposed to be conducted including its capital needs taking into account the particular capital requirements of the business conducted by the Company, consolidated and projected capital requirements and capital availability thereof, and (iii) the current cash flow of the Company, together with the proceeds the Company would receive, were it to liquidate all of its assets, after taking into account all anticipated uses of the cash, would be sufficient to pay all amounts on or in respect of its liabilities when such amounts are required to be paid. The Company does not intend to incur debts beyond its ability to pay such debts as they mature (taking into account the timing and amounts of cash to be payable on or in respect of its debt). The Company has no knowledge of any facts or circumstances which lead it to believe that it will file for reorganization or liquidation under the bankruptcy or reorganization laws of any jurisdiction within one year from the Closing Date. Schedule 3.1(aa) sets forth as of the date hereof all outstanding secured and unsecured Indebtedness of the Company or any Subsidiary, or for which the Company or any Subsidiary has commitments. For the purposes of this Agreement, “Indebtedness” means (x) any liabilities for borrowed money or amounts owed in excess of $50,000 (other than trade accounts payable incurred in the ordinary course of business), (y) all guaranties, endorsements and other contingent obligations in respect of indebtedness of others, whether or not the same are or should be reflected in the Company’s consolidated balance sheet (or the notes thereto), except guaranties by endorsement of negotiable instruments for deposit or collection or similar transactions in the ordinary course of business; and (z) the present value of any lease payments in excess of $50,000 due under leases required to be capitalized in accordance with GAAP. Neither the Company nor any Subsidiary is in default with respect to any Indebtedness. |
|
(bb) |
Tax Compliance. Except for matters that would not, individually or in the aggregate, have or reasonably be expected to result in a Material Adverse Effect, the Company and its Subsidiaries each (i) has made or filed all federal, state and local income and all foreign tax returns, reports and declarations required by any jurisdiction to which it is subject, (ii) has paid all taxes and other governmental assessments and charges, fines or penalties that are material in amount, shown or determined to be due on such returns, reports and declarations and (iii) has set aside on its financial statements provision reasonably adequate for the payment of all material tax liability of which has not been finally determined and all material taxes for periods subsequent to the periods to which such returns, reports or declarations apply. There are no unpaid taxes in any material amount claimed to be due by the taxing authority of any jurisdiction, and the officers of the Company or of any Subsidiary know of no basis for any such claim. |
|
(cc) |
Foreign Corrupt Practices. Neither the Company nor any Subsidiary, nor to the knowledge of the Company or any Subsidiary, any agent or other person acting on behalf of the Company or any Subsidiary, has (i) directly or indirectly, used any funds for unlawful contributions, gifts, entertainment or other unlawful expenses related to foreign or domestic political activity, (ii) made any unlawful payment to foreign or domestic government officials or employees or to any foreign or domestic political parties or campaigns from corporate funds, (iii) failed to disclose fully any contribution made by the Company or any Subsidiary (or made by any person acting on its behalf of which the Company is aware) which is in violation of law, or (iv) violated in any material respect any provision of FCPA. |
|
(dd) |
Accountants. The Company’s independent registered public accounting firm is as set forth in the Prospectus. To the knowledge and belief of the Company, such accounting firm (i) is a registered public accounting firm as required by the Exchange Act and (ii) shall express its opinion with respect to the financial statements to be included in the Company’s Annual Report for the fiscal year ending December 31, 2023. |
|
(ee) |
Acknowledgment Regarding Purchasers’ Purchase of Securities. The Company acknowledges and agrees that each of the Purchasers is acting solely in the capacity of an arm’s length purchaser with respect to the Transaction Documents and the transactions contemplated thereby. The Company further acknowledges that no Purchaser is acting as a financial advisor or fiduciary of the Company (or in any similar capacity) with respect to the Transaction Documents and the transactions contemplated thereby and any advice given by any Purchaser or any of their respective representatives or agents in connection with the Transaction Documents and the transactions contemplated thereby is merely incidental to the Purchasers’ purchase of the Securities. The Company further represents to each Purchaser that the Company’s decision to enter into this Agreement and the other Transaction Documents has been based solely on the independent evaluation of the transactions contemplated hereby by the Company and its representatives. |
|
(ff) |
Acknowledgment Regarding Purchaser’s Trading Activity. Anything in this Agreement or elsewhere herein to the contrary notwithstanding (except for 4.12 hereof), it is understood and acknowledged by the Company that: (i) none of the Purchasers has been asked by the Company to agree, nor has any Purchaser agreed, to desist from purchasing or selling, long and/or short, securities of the Company, or “derivative” securities based on securities issued by the Company or to hold the Securities for any specified term; (ii) past or future open market or other transactions by any Purchaser, specifically including, without limitation, Short Sales or “derivative” transactions, before or after the closing of this or future private placement transactions, may negatively impact the market price of the Company’s publicly-traded securities; (iii) any Purchaser, and counter-parties in “derivative” transactions to which any such Purchaser is a party, directly or indirectly, presently may have a “short” position in the shares of Common Stock, and (iv) each Purchaser shall not be deemed to have any affiliation with or control over any arm’s length counter-party in any “derivative” transaction. The Company further understands and acknowledges that (y) one or more Purchasers may engage in hedging activities at various times during the period that the Securities are outstanding, and (z) such hedging activities (if any) could reduce the value of the existing stockholders’ equity interests in the Company at and after the time that the hedging activities are being conducted. The Company acknowledges that such aforementioned hedging activities do not constitute a breach of any of the Transaction Documents. |
|
(gg) |
Regulation M Compliance. The Company has not, and to its knowledge no one acting on its behalf has, (i) taken, directly or indirectly, any action designed to cause or to result in the stabilization or manipulation of the price of any security of the Company to facilitate the sale or resale of any of the shares of Common Stock, (ii) sold, bid for, purchased, or, paid any compensation for soliciting purchases of, any of the shares of Common Stock, or (iii) paid or agreed to pay to any Person any compensation for soliciting another to purchase any other securities of the Company, other than, in the case of clauses (ii) and (iii), compensation paid to the Placement Agent in connection with the placement of the shares of Common Stock. |
|
(hh) |
Stock Option Plans. Each stock option granted by the Company under the Company’s stock incentive plans was granted (i) in accordance with the terms of such plan and (ii) with an exercise price at least equal to the fair market value of the Common Stock on the date such stock option would be considered granted under GAAP and applicable law. No stock option granted under the Company’s stock option plan has been backdated. |
|
(ii) |
Cybersecurity. Except as would not, individually or in the aggregate, have a Material Adverse Effect, (i) the Company and the Subsidiaries are presently in compliance with all applicable laws or statutes and all judgments, orders, rules and regulations of any court or arbitrator or governmental or regulatory authority, internal policies and contractual obligations relating to the privacy and security of the Company’s or any Subsidiary’s information technology and computer systems, networks, hardware, software, data (including the data of its respective customers, employees, suppliers, vendors and any third party data maintained by or on behalf of it), equipment or technology (collectively, “IT Systems and Data”) and to the protection of such IT Systems and Data from unauthorized use, access, misappropriation or modification; (ii) the Company and the Subsidiaries have implemented and maintained commercially reasonable safeguards to maintain and protect its material confidential information and the integrity, continuous operation, redundancy and security of all IT Systems and Data; and (iii) the Company and the Subsidiaries have implemented backup and disaster recovery technology consistent with commercially reasonable industry standards and practices. |
|
(jj) |
FDA. As to each product subject to the jurisdiction of the U.S. Food and Drug Administration (“FDA”) under the Federal Food, Drug and Cosmetic Act, as amended, and the regulations thereunder (“FDCA”) that is manufactured, packaged, labeled, tested, distributed, sold, and/or marketed by the Company or any of its Subsidiaries (each such product, a “Pharmaceutical Product”), such Pharmaceutical Product is being manufactured, packaged, labeled, tested, distributed, sold and/or marketed by the Company in compliance with all applicable requirements under FDCA and similar laws, rules and regulations relating to registration, investigational use, premarket clearance, licensure, or application approval, good manufacturing practices, good laboratory practices, good clinical practices, product listing, quotas, labeling, advertising, record keeping and filing of reports, except where the failure to be in compliance would not have a Material Adverse Effect. There is no pending, completed or, to the Company's knowledge, threatened, action (including any lawsuit, arbitration, or legal or administrative or regulatory proceeding, charge, complaint, or investigation) against the Company or any of its Subsidiaries, and none of the Company or any of its Subsidiaries has received any notice, warning letter or other communication from the FDA or any other governmental entity, which (i) contests the premarket clearance, licensure, registration, or approval of, the uses of, the distribution of, the manufacturing or packaging of, the testing of, the sale of, or the labeling and promotion of any Pharmaceutical Product, (ii) withdraws its approval of, requests the recall, suspension, or seizure of, or withdraws or orders the withdrawal of advertising or sales promotional materials relating to, any Pharmaceutical Product, (iii) imposes a clinical hold on any clinical investigation by the Company or any of its Subsidiaries, (iv) enjoins production at any facility of the Company or any of its Subsidiaries, (v) enters or proposes to enter into a consent decree of permanent injunction with the Company or any of its Subsidiaries, or (vi) otherwise alleges any violation of any laws, rules or regulations by the Company or any of its Subsidiaries, and which, either individually or in the aggregate, would have a Material Adverse Effect. The properties, business and operations of the Company have been and are being conducted in all material respects in accordance with all applicable laws, rules and regulations of the FDA. The Company has not been informed by the FDA that the FDA will prohibit the marketing, sale, license or use in the United States of any product proposed to be developed, produced or marketed by the Company nor has the FDA expressed any concern as to approving or clearing for marketing any product being developed or proposed to be developed by the Company. |
|
(kk) |
Office of Foreign Assets Control. Neither the Company nor any Subsidiary nor, to the Company’s knowledge, any director, officer, agent, employee or affiliate of the Company or any Subsidiary is currently subject to any U.S. sanctions administered by the Office of Foreign Assets Control of the U.S. Treasury Department (“OFAC”). |
|
(ll) |
Money Laundering. The operations of the Company and its Subsidiaries are and have been conducted at all times in compliance with applicable financial record-keeping and reporting requirements of the Currency and Foreign Transactions Reporting Act of 1970, as amended, applicable money laundering statutes and applicable rules and regulations thereunder (collectively, the “Money Laundering Laws”), and no action, suit or proceeding by or before any court or governmental agency, authority or body or any arbitrator involving the Company or any Subsidiary with respect to the Money Laundering Laws is pending or, to the knowledge of the Company or any Subsidiary, threatened. |
3.2 Representations and Warranties of the Purchasers.
Each Purchaser, for itself and for no other Purchaser, hereby represents and warrants as of the date hereof and as of the Closing Date
to the Company as follows (unless as of a specific date therein, in which case they shall be accurate as of such date):
|
(a) |
Organization; Authority. Such Purchaser is either an individual or an entity duly incorporated or formed, validly existing and in good standing under the laws of the jurisdiction of its incorporation or formation with full right, corporate, partnership limited liability company or similar power and authority to enter into and to consummate the transactions contemplated by the Transaction Documents and otherwise to carry out its obligations hereunder and thereunder. The execution and delivery of the Transaction Documents and performance by such Purchaser of the transactions contemplated by the Transaction Documents have been duly authorized by all necessary corporate, partnership, limited liability company or similar action, as applicable, on the part of such Purchaser. Each Transaction Document to which it is a party has been duly executed by such Purchaser, and when delivered by such Purchaser in accordance with the terms hereof, will constitute the valid and legally binding obligation of such Purchaser, enforceable against it in accordance with its terms, except: (i) as limited by general equitable principles and applicable bankruptcy, insolvency, reorganization, moratorium and other laws of general application affecting enforcement of creditors’ rights generally, (ii) as limited by laws relating to the availability of specific performance, injunctive relief or other equitable remedies and (iii) insofar as indemnification and contribution provisions may be limited by applicable law. |
|
(b) |
Understandings or Arrangements. Such Purchaser is acquiring the Securities as principal for its own account and has no direct or indirect arrangement or understandings with any other persons to distribute or regarding the distribution of such Securities (this representation and warranty not limiting such Purchaser’s right to sell the Securities pursuant to the Registration Statement or otherwise in compliance with applicable federal and state securities laws). |
|
(c) |
Experience of Such Purchaser. Such Purchaser, either alone or together with its representatives, has such knowledge, sophistication and experience in business and financial matters so as to be capable of evaluating the merits and risks of the prospective investment in the Securities, and has so evaluated the merits and risks of such investment. Such Purchaser is able to bear the economic risk of an investment in the Securities and, at the present time, is able to afford a complete loss of such investment. |
|
(d) |
Certain Transactions and Confidentiality. Other than consummating the transactions contemplated hereunder, such Purchaser has not, nor has any Person acting on behalf of or pursuant to any understanding with such Purchaser, directly or indirectly executed any purchases or sales, including Short Sales, of the securities of the Company during the period commencing as of the time that such Purchaser first received a term sheet (written or oral) from the Company or any other Person representing the Company setting forth the material terms, which terms include definitive pricing terms, of the transactions contemplated hereunder and ending immediately prior to the execution hereof. Notwithstanding the foregoing, in the case of a Purchaser that is a multi-managed investment vehicle whereby separate portfolio managers manage separate portions of such Purchaser’s assets and the portfolio managers have no direct knowledge of the investment decisions made by the portfolio managers managing other portions of such Purchaser’s assets, the representation set forth above shall only apply with respect to the portion of assets managed by the portfolio manager that made the investment decision to purchase the Securities covered by this Agreement. Other than to other Persons party to this Agreement or to such Purchaser’s representatives, including, without limitation, its officers, directors, partners, legal and other advisors, employees, agents and Affiliates, such Purchaser has maintained the confidentiality of all disclosures made to it in connection with this transaction (including the existence and terms of this transaction). Notwithstanding the foregoing, for the avoidance of doubt, nothing contained herein shall constitute a representation or warranty, or preclude any actions, with respect to locating or borrowing shares order to effect Short Sales or similar transactions in the future. |
|
(e) |
Independent Advice. Each Purchaser understands that nothing in this Agreement or any other materials presented by or on behalf of the Company to the Purchaser in connection with the purchase of the Securities constitutes legal, tax or investment advice. |
The Company acknowledges and
agrees that the representations contained in this Section 3.2 shall not modify, amend or affect such Purchaser’s right to rely
on the Company’s representations and warranties contained in this Agreement or any representations and warranties contained in any
other Transaction Document or any other document or instrument executed and/or delivered in connection with this Agreement or the consummation
of the transactions contemplated hereby. Notwithstanding the foregoing, for the avoidance of doubt, nothing contained herein shall constitute
a representation or warranty, or preclude any actions, except as set forth in this Agreement, with respect to locating or borrowing shares
in order to effect Short Sales or similar transactions in the future.
Section 4.
OTHER AGREEMENTS OF THE PARTIES
4.1 Legends. The shares of Common Stock
and the Warrant Shares shall be issued free of legends. If at any time following the date hereof the Registration Statement is not effective
or is not otherwise available for the sale of the shares of Common Stock, the Warrants or the Warrant Shares, the Company shall immediately
notify the holders of the Warrants in writing that such registration statement is not then effective and thereafter shall promptly notify
such holders when the registration statement is effective again and available for the sale of the Shares, the Warrants or the Warrant
Shares (it being understood and agreed that the foregoing shall not limit the ability of the Company to issue, or any Purchaser to sell,
any of the Shares, the Warrants or the Warrant Shares in compliance with applicable federal and state securities laws). The Company shall
use commercially reasonable best efforts to keep a registration statement (including the Registration Statement) registering the issuance
of the Warrant Shares effective during the term of the Warrants.
4.2 Furnishing of Information; Public Information.
Until the earliest of the time that (i) no Purchaser owns Securities, or (ii) the Common Warrants have expired, the Company
covenants to maintain the registration of the Common Stock under Section 12(b) or 12(g) of the Exchange Act and to timely
file (or obtain extensions in respect thereof and file within the applicable grace period) all reports required to be filed by the Company
after the date hereof pursuant to the Exchange Act, even if the Company is not then subject to the reporting requirements of the Exchange
Act, (in each case on or after the date as of which the Purchasers may sell all of their Securities without restriction or limitation
pursuant to Rule 144) except in the event that the Company consummates: (a) any transaction or series of related transactions
as a result of which any Person (together with its Affiliates) acquires then outstanding securities of the Company representing more than
fifty percent (50%) of the voting control of the Company; (b) a merger or reorganization of the Company with one or more other entities
in which the Company is not the surviving entity; or (c) a sale of all or substantially all of the assets of the Company, where the
consummation of such transaction results in the Company no longer being subject to the reporting requirements of the Exchange Act.
4.3 Integration. The Company shall not
sell, offer for sale or solicit offers to buy or otherwise negotiate in respect of any security (as defined in Section 2 of the Securities
Act) that would be integrated with the offer or sale of the Securities for purposes of the rules and regulations of any Trading Market
such that it would require shareholder approval prior to the closing of such other transaction unless shareholder approval is obtained
before the closing of such subsequent transaction.
4.4 Securities Laws Disclosure; Publicity.
The Company shall (a) by the Disclosure Time, issue a press release disclosing the material terms of the transactions contemplated
hereby, and (b) file a Current Report on Form 8-K, including the Transaction Documents as exhibits thereto, with the Commission
within the time required by the Exchange Act. From and after the issuance of such press release, the Company represents to the Purchasers
that it shall have publicly disclosed all material, non-public information delivered to any of the Purchasers by the Company or any of
its Subsidiaries, or any of their respective officers, directors, employees or agents in connection with the transactions contemplated
by the Transaction Documents. In addition, effective upon the issuance of such press release, the Company acknowledges and agrees that
any and all confidentiality or similar obligations under any agreement, whether written or oral, between the Company, any of its Subsidiaries
or any of their respective officers, directors, agents, employees or Affiliates on the one hand, and any of the Purchasers or any of their
Affiliates on the other hand, shall terminate. The Company and each Purchaser shall consult with each other in issuing any other press
releases with respect to the transactions contemplated hereby, and neither the Company nor any Purchaser shall issue any such press release
nor otherwise make any such public statement without the prior consent of the Company, with respect to any press release of any Purchaser,
or without the prior consent of each Purchaser, with respect to any press release of the Company, which consent shall not unreasonably
be withheld or delayed, except if such disclosure is required by law, in which case the disclosing party shall promptly provide the other
party with prior notice of such public statement or communication. Notwithstanding the foregoing, the Company shall not publicly disclose
the name of any Purchaser, or include the name of any Purchaser in any filing with the Commission or any regulatory agency or Trading
Market, without the prior written consent of such Purchaser, except (a) as required by federal securities law in connection with
the filing of final Transaction Documents with the Commission, and (b) to the extent such disclosure is required by law or Trading
Market regulations, in which case the Company shall provide the Purchasers with prior notice of such disclosure permitted under this clause
(b).
4.5 Stockholder Rights Plan. No claim will
be made or enforced by the Company or, with the consent of the Company, any other Person, that any Purchaser is an “Acquiring Person”
under any control share acquisition, business combination, poison pill (including any distribution under a rights agreement) or similar
anti-takeover plan or arrangement in effect or hereafter adopted by the Company, or that any Purchaser could be deemed to trigger the
provisions of any such plan or arrangement, by virtue of receiving Securities under the Transaction Documents or under any other agreement
between the Company and the Purchasers.
4.6 Non-Public Information. Except with
respect to the material terms and conditions of the transactions contemplated by the Transaction Documents, which shall be disclosed pursuant
to Section 4.4, the Company covenants and agrees that neither it, nor any other Person acting on its behalf will provide any Purchaser
or its agents or counsel with any information that the Company reasonably believes constitutes material non-public information, unless
prior thereto such Purchaser shall have entered into a written agreement with the Company regarding the confidentiality and use of such
information. The Company understands and confirms that each Purchaser shall be relying on the foregoing covenant in effecting transactions
in securities of the Company. To the extent that the Company delivers any material, non-public information to a Purchaser without such
Purchaser’s consent, the Company hereby covenants and agrees that such Purchaser shall not have any duty of confidentiality to the
Company, any of its Subsidiaries, or any of their respective officers, directors, agents, employees or Affiliates, or a duty to the Company,
and of its Subsidiaries or any of their respective officers, directors, agents, employees or Affiliates not to trade on the basis of,
such material, non-public information, provided that the Purchaser shall remain subject to applicable law. To the extent that any notice
provided pursuant to any Transaction Document constitutes, or contains, material, non-public information regarding the Company or any
Subsidiaries, the Company shall simultaneously file such notice with the Commission pursuant to a Current Report on Form 8-K. The
Company understands and confirms that each Purchaser shall be relying on the foregoing covenant in effecting transactions in securities
of the Company.
4.7 Use of Proceeds. Although the Company
intends to use the net proceeds from the sale of the Securities hereunder for general working capital purposes and potential acquisitions],
the Company has discretion in the application of the net proceeds of the Offering.
4.8 Indemnification of Purchasers. Subject
to the provisions of this Section 4.8, the Company will indemnify and hold each Purchaser and its directors, officers, shareholders,
members, partners, employees and agents (and any other Persons with a functionally equivalent role of a Person holding such titles notwithstanding
a lack of such title or any other title), each Person who controls such Purchaser (within the meaning of Section 15 of the Securities
Act and Section 20 of the Exchange Act), and the directors, officers, shareholders, agents, members, partners or employees (and any
other Persons with a functionally equivalent role of a Person holding such titles notwithstanding a lack of such title or any other title)
of such controlling persons (each, a “Purchaser Party”) harmless from any and all losses, liabilities, obligations, claims,
contingencies, damages, costs and expenses, including all judgments, amounts paid in settlements, court costs and reasonable attorneys’
fees and costs of investigation that any such Purchaser Party may suffer or incur as a result of or relating to (a) any breach of
any of the representations, warranties, covenants or agreements made by the Company in this Agreement or in the other Transaction Documents
or (b) any action instituted against the Purchaser Parties in any capacity (including a Purchaser Party’s status as an investor),
or any of them or their respective Affiliates, any stockholder of the Company who is not an Affiliate of such Purchaser Party, arising
out of or relating to any of the transactions contemplated by the Transaction Documents (unless such action is based upon a material breach
of such Purchaser Party’s representations, warranties, covenants or agreements made by such Purchaser Party in any Transaction Document
or any conduct by a Purchaser Party which is finally judicially determined to constitute fraud, gross negligence or willful misconduct).
If any action shall be brought against any Purchaser Party in respect of which indemnity may be sought pursuant to this Agreement, such
Purchaser Party shall promptly notify the Company in writing, and the Company shall have the right to assume the defense thereof with
counsel of its own choosing reasonably acceptable to the Purchaser Party. Any Purchaser Party shall have the right to employ separate
counsel in any such action and participate in the defense thereof, but the fees and expenses of such counsel shall be at the expense of
such Purchaser Party except to the extent that (i) the employment thereof has been specifically authorized by the Company in writing,
(ii) the Company has failed after a reasonable period of time to assume such defense and to employ counsel or (iii) in such
action there is, in the reasonable opinion of counsel to the applicable Purchaser Party (which may be internal counsel), a material conflict
on any material issue between the position of the Company and the position of such Purchaser Party, in which case the Company shall be
responsible for the reasonable fees and expenses of no more than one such separate counsel. The Company will not be liable to any Purchaser
Party under this Agreement for any settlement by a Purchaser Party effected without the Company’s prior written consent, which shall
not be unreasonably withheld or delayed, or the extent that a loss, claim, damage, or liability is attributable to any Purchaser Party’s
breach of any of the representations, warranties, covenants or agreements made by such Purchaser Party in this Agreement or in the other
Transaction Documents. The indemnification and other payment obligations required by this Section 4.8 shall be made by periodic payments
of the amount thereof during the course of the investigation, defense, collection, enforcement or action, as and when bills are received
or are incurred; provided, that if any Purchaser Party is finally judicially determined not to be entitled to indemnification or payment
under this Section 4.8, such Purchaser Party shall promptly reimburse the Company for any payments that are advanced under this sentence.
The indemnity agreements contained herein shall be in addition to any cause of action or similar right of any Purchaser Party against
the Company or others and any liabilities the Company may be subject to pursuant to law.
4.9 Listing of Shares. The Company hereby
agrees to use commercially reasonable best efforts to maintain the listing or quotation of the shares of Common Stock on each Trading
Market on which each is currently listed, and concurrently with the Closing, the Company shall apply to list or quote all of the shares
of Common Stock on such Trading Markets and promptly secure the listing of all of the shares of Common Stock on such Trading Markets.
The Company further agrees, if the Company applies to have the Common Stock traded on any other Trading Market, it will then include in
such application all of the shares of Common Stock and Warrant Shares, and will take such other action as is necessary to cause all of
the shares of Common Stock and Warrant Shares to be listed or quoted on such other Trading Market as promptly as possible. The Company
will then take all action reasonably necessary to continue the listing and trading of the Common Stock on a Trading Market and will comply
in all material respects with the Company’s reporting, filing and other obligations under the bylaws or rules of the Trading
Market. The Company agrees to use commercially reasonable efforts to maintain the eligibility of the for electronic transfer through the
Depository Trust Company or another established clearing corporation, including, without limitation, by timely payment of fees to the
Depository Trust Company or such other established clearing corporation in connection with such electronic transfer. Notwithstanding anything
to the contrary contained in this Agreement, none of the foregoing shall apply in the event that the Company consummates (a) any
transaction or series of related transactions as a result of which any Person (together with its Affiliates) acquires then outstanding
securities of the Company representing more than fifty percent (50%) of the voting control of the Company; (b) a merger or reorganization
of the Company with one or more other entities in which the Company is not the surviving entity; or (c) a sale of all or substantially
all of the assets of the Company, where the consummation of such transaction results in the Company no longer being subject to the reporting
requirements of the Exchange Act
4.10 Subsequent Equity Sales.
|
(a) |
From the date hereof until sixty (60) days after the Closing Date, neither the Company nor any Subsidiary shall (i) issue, enter into any agreement to issue or announce the issuance or proposed issuance of any shares of Common Stock or Common Stock Equivalents or (ii) file any registration statement or amendment or supplement thereto, other than the Prospectus Supplement or filing a registration statement on Form S-8 in connection with any employee benefit plan. |
|
(b) |
From the date hereof until the six (6) month anniversary of the Closing Date, the Company shall be prohibited from effecting or entering into an agreement to effect any issuance by the Company or any of its Subsidiaries of shares of Common Stock or Common Stock Equivalents (or a combination of units thereof) involving a Variable Rate Transaction. “Variable Rate Transaction” means a transaction in which the Company (i) issues or sells any debt or equity securities that are convertible into, exchangeable or exercisable for, or include the right to receive additional shares of Common Stock either (A) at a conversion price, exercise price or exchange rate or other price that is based upon and/or varies with the trading prices of or quotations for the Common Stock at any time after the initial issuance of such debt or equity securities, or (B) with a conversion, exercise or exchange price that is subject to being reset at some future date after the initial issuance of such debt or equity security or upon the occurrence of specified or contingent events directly or indirectly related to the business of the Company or the market for shares of Common Stock or (ii) enters into, or effects a transaction under, any agreement, including, but not limited to, an equity line of credit or an “at-the-market offering”, whereby the Company may issue securities at a future determined price regardless of whether shares pursuant to such agreement have actually been issued and regardless of whether such agreement is subsequently canceled. Any Purchaser shall be entitled to obtain injunctive relief against the Company to preclude any such issuance, which remedy shall be in addition to any right to collect damages. |
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(c) |
Notwithstanding the foregoing, this Section 4.10 shall not apply (1) in respect of an Exempt Issuance, except that no Variable Rate Transaction shall be an Exempt Issuance (2) following the fifteen (15) day anniversary of the Closing Date, to the filing of a prospectus supplement with respect to sales under the at-the-market offering in which the Placement Agent is a sales agent, pursuant to the Amended and Restated At Market Issuance Sales Agreement, dated February 9, 2021, between the Company and the Placement Agent, as amended by Amendment No. 1 thereto, dated May 3, 2021, and Amendment No. 2 thereto, dated May 2, 2024 (the “Sales Agreement”) and (3) following the forty-five (45) day anniversary of the Closing Date, to the sale and issuance of securities in an at-the-market offering pursuant to the Sales Agreement. |
4.11 Equal Treatment of Purchasers. No
consideration (including any modification of the Transaction Documents) shall be offered or paid to any Person to amend or consent to
a waiver or modification of any provision of the Transaction Documents unless the same consideration is also offered to all of the parties
to the Transaction Documents. For clarification purposes, this provision constitutes a separate right granted to each Purchaser by the
Company and negotiated separately by each Purchaser, and is intended for the Company to treat the Purchasers as a class and shall not
in any way be construed as the Purchasers acting in concert or as a group with respect to the purchase, disposition or voting of the shares
of Common Stock or otherwise.
4.12 Certain Transactions and Confidentiality.
Each Purchaser, severally and not jointly with the other Purchasers, covenants that neither it nor any Affiliate acting on its behalf
or pursuant to any understanding with it will execute any purchases or sales, including Short Sales of any of the Company’s securities
during the period commencing with the execution of this Agreement and ending at such time that the transactions contemplated by this Agreement
are first publicly announced pursuant to the initial press release as described in Section 4.4. Each Purchaser, severally and not
jointly with the other Purchasers, covenants that until such time as the transactions contemplated by this Agreement are publicly disclosed
by the Company pursuant to the initial press release as described in Section 4.4, such Purchaser will maintain the confidentiality
of the existence and terms of this transaction. Notwithstanding the foregoing, and notwithstanding anything contained in this Agreement
to the contrary, the Company expressly acknowledges and agrees that (i) no Purchaser makes any representation, warranty or covenant
hereby that it will not engage in effecting transactions in any securities of the Company after the time that the transactions contemplated
by this Agreement are first publicly announced pursuant to the initial press release as described in Section 4.4, (ii) no Purchaser
shall be restricted or prohibited from effecting any transactions in any securities of the Company in accordance with applicable securities
laws from and after the time that the transactions contemplated by this Agreement are first publicly announced pursuant to the initial
press release as described in Section 4.4 and (iii) no Purchaser shall have any duty of confidentiality or duty not to trade
in the securities of the Company to the Company or its Subsidiaries after the issuance of the initial press release as described in Section 4.4.
Notwithstanding the foregoing, in the case of a Purchaser that is a multi-managed investment vehicle whereby separate portfolio managers
manage separate portions of such Purchaser’s assets and the portfolio managers have no direct knowledge of the investment decisions
made by the portfolio managers managing other portions of such Purchaser’s assets, the covenant set forth above shall only apply
with respect to the portion of assets managed by the portfolio manager that made the investment decision to purchase the Securities covered
by this Agreement.
4.13 Exercise Procedures. The form of Notice
of Exercise included in the Warrants set forth the totality of the procedures required of the Purchasers in order to exercise the Warrants.
No additional legal opinion, other information or instructions shall be required of the Purchasers to exercise their Warrants. Without
limiting the preceding sentences, no ink-original Notice of Exercise shall be required, nor shall any medallion guarantee (or other type
of guarantee or notarization) of any Notice of Exercise form be required in order to exercise the Warrants. The Company shall honor exercises
of the Warrants and shall deliver shares of Common Stock and/or Warrant Shares in accordance with the terms, conditions and time periods
set forth in the Transaction Documents.
4.14 Reservations of Shares. As of the
date hereof, the Company has reserved and the Company shall continue to reserve and keep available at all times, free of preemptive rights,
a sufficient number of shares of Common Stock for the purpose of enabling the Company to issue shares of Common Stock pursuant to this
Agreement and Warrant Shares pursuant to any exercise of the Warrants.
4.15 Lock-Up Agreements. The Company shall
not amend, modify, waive or terminate any provision of any of the Lock-Up Agreements without the prior written consent of the Placement
Agent, except to extend the term of the lock-up period, and shall enforce the provisions of each Lock-Up Agreement in accordance with
its terms. If any party to a Lock-Up Agreement breaches any provision of a Lock-Up Agreement, the Company shall promptly use its best
efforts to seek specific performance of the terms of such Lock-Up Agreement.
Section 5.
MISCELLANEOUS
5.1 Termination. This Agreement may be
terminated by any Purchaser, as to such Purchaser’s obligations hereunder only and without any effect whatsoever on the obligations
between the Company and the other Purchasers, by written notice to the other parties, if the Closing has not been consummated on or before
the fifth (5th) Trading Day following the date hereof; provided, however, that no such termination will affect the right
of any party to sue for any breach by any other party (or parties).
5.2 Fees and Expenses. Except as expressly
set forth in the Transaction Documents to the contrary, each party shall pay the fees and expenses of its advisers, counsel, accountants
and other experts, if any, and all other expenses incurred by such party incident to the negotiation, preparation, execution, delivery
and performance of this Agreement. The Company shall pay all Depositary Fees (including, without limitation, any fees required for same-day
processing of any instruction letter delivered by the Company and any exercise notice delivered by a Purchaser), stamp taxes and other
taxes and duties levied in connection with the delivery of any Securities to the Purchasers.
5.3 Entire Agreement. The Transaction Documents,
together with the exhibits and schedules thereto, the Preliminary Prospectus and the Prospectus, contain the entire understanding of the
parties with respect to the subject matter hereof and thereof and supersede all prior agreements and understandings, oral or written,
with respect to such matters, which the parties acknowledge have been merged into such documents, exhibits and schedules.
5.4 Notices. Any and all notices or other
communications or deliveries required or permitted to be provided hereunder shall be in writing and shall be deemed given and effective
on the earliest of: (a) the time of transmission, if such notice or communication is delivered via facsimile at the facsimile number
or email attachment at the email address as set forth on the signature pages attached hereto at or prior to 5:30 p.m. (New York
City time) on a Trading Day, (b) the next Trading Day after the time of transmission, if such notice or communication is delivered
via facsimile at the facsimile number or email attachment at the email address as set forth on the signature pages attached hereto
on a day that is not a Trading Day or later than 5:30 p.m. (New York City time) on any Trading Day, (c) the second (2nd) Trading
Day following the date of mailing, if sent by U.S. nationally recognized overnight courier service or (d) upon actual receipt by
the party to whom such notice is required to be given. The address for such notices and communications shall be as set forth on the signature
pages attached hereto. To the extent that any notice provided pursuant to any Transaction Document constitutes, or contains, material,
non-public information regarding the Company or any Subsidiaries, the Company shall simultaneously file such notice with the Commission
pursuant to a Current Report on Form 8-K.
5.5 Amendments; Waivers. No provision of
this Agreement may be waived, modified, supplemented or amended except in a written instrument signed, in the case of an amendment, by
the Company and the Purchasers who execute this Agreement and who purchased at least 50.1% in interest of the sum of (i) the Shares
and (ii) the Pre-Funded Warrant Shares initially issuable upon exercise of the Pre-Funded Warrants based on the initial Subscription
Amounts hereunder, or, in the case of a waiver, by the party against whom enforcement of any such waived provision is sought; provided,
that if any amendment, modification or waiver disproportionately and adversely impacts a Purchaser (or group of Purchasers), the consent
of at least 50.1% in interest of such disproportionately impacted Purchaser execute this Agreement and who (or group of Purchasers) shall
also be required. No waiver of any default with respect to any provision, condition or requirement of this Agreement shall be deemed to
be a continuing waiver in the future or a waiver of any subsequent default or a waiver of any other provision, condition or requirement
hereof, nor shall any delay or omission of any party to exercise any right hereunder in any manner impair the exercise of any such right.
Any proposed amendment or waiver that disproportionately, materially and adversely affects the rights and obligations of any Purchaser
relative to the comparable rights and obligations of the other Purchasers shall require the prior written consent of such adversely affected
Purchaser. Any amendment effected in accordance with this Section 5.5 shall be binding upon each Purchaser and holder of Securities
and the Company.
5.6 Headings. The headings herein are for
convenience only, do not constitute a part of this Agreement and shall not be deemed to limit or affect any of the provisions hereof.
5.7 Successors and Assigns. This Agreement
shall be binding upon and inure to the benefit of the parties and their successors and permitted assigns. The Company may not assign this
Agreement or any rights or obligations hereunder without the prior written consent of each Purchaser (other than by merger). Any Purchaser
may assign any or all of its rights under this Agreement to any Person to whom such Purchaser assigns or transfers any Securities, provided
that such transferee agrees in writing to be bound, with respect to the transferred Securities, by the provisions of the Transaction Documents
that apply to the “Purchasers.”
5.8 No Third-Party Beneficiaries. The Placement
Agent shall be the third-party beneficiary of the representations and warranties of the Company in Section 3.1 and the representations
and warranties of the Purchasers in Section 3.2. This Agreement is intended for the benefit of the parties hereto and their respective
successors and permitted assigns and is not for the benefit of, nor may any provision hereof be enforced by, any other Person, except
as otherwise set forth in Section 4.8 and this Section 5.8.
5.9 Governing Law. All questions concerning
the construction, validity, enforcement and interpretation of the Transaction Documents shall be governed by and construed and enforced
in accordance with the internal laws of the State of New York, without regard to the principles of conflicts of law thereof. Each party
agrees that all legal proceedings concerning the interpretations, enforcement and defense of the transactions contemplated by this Agreement
and any other Transaction Documents (whether brought against a party hereto or its respective affiliates, directors, officers, shareholders,
partners, members, employees or agents) shall be commenced exclusively in the state and federal courts sitting in the state of New York.
Each party hereby irrevocably submits to the exclusive jurisdiction of the state and federal courts sitting in the state of New York for
the adjudication of any dispute hereunder or in connection herewith or with any transaction contemplated hereby or discussed herein (including
with respect to the enforcement of any of the Transaction Documents), and hereby irrevocably waives, and agrees not to assert in any suit,
action or proceeding, any claim that it is not personally subject to the jurisdiction of any such court, that such suit, action or proceeding
is improper or is an inconvenient venue for such proceeding. Each party hereby irrevocably waives personal service of process and consents
to process being served in any such suit, action or proceeding by mailing a copy thereof via registered or certified mail or overnight
delivery (with evidence of delivery) to such party at the address in effect for notices to it under this Agreement and agrees that such
service shall constitute good and sufficient service of process and notice thereof. Nothing contained herein shall be deemed to limit
in any way any right to serve process in any other manner permitted by law. If either party shall commence an action, suit or proceeding
to enforce any provisions of the Transaction Documents, then, in addition to the obligations of the Company under Section 4.8, the
prevailing party in such action, suit or proceeding shall be reimbursed by the other party for its reasonable attorneys’ fees and
other costs and expenses incurred with the investigation, preparation and prosecution of such action or proceeding.
5.10 Survival. The representations and
warranties contained herein shall survive the Closing and the delivery of the Securities for the applicable statute of limitations.
5.11 Execution. This Agreement may be executed
in two or more counterparts, all of which when taken together shall be considered one and the same agreement and shall become effective
when counterparts have been signed by each party and delivered to each other party, it being understood that the parties need not sign
the same counterpart. In the event that any signature is delivered by facsimile transmission or by e-mail delivery of a “.pdf”
format data file, such signature shall create a valid and binding obligation of the party executing (or on whose behalf such signature
is executed) with the same force and effect as if such facsimile or “.pdf” signature page was an original thereof.
5.12 Severability. If any term, provision,
covenant or restriction of this Agreement is held by a court of competent jurisdiction to be invalid, illegal, void or unenforceable,
the remainder of the terms, provisions, covenants and restrictions set forth herein shall remain in full force and effect and shall in
no way be affected, impaired or invalidated, and the parties hereto shall use their commercially reasonable efforts to find and employ
an alternative means to achieve the same or substantially the same result as that contemplated by such term, provision, covenant or restriction.
It is hereby stipulated and declared to be the intention of the parties that they would have executed the remaining terms, provisions,
covenants and restrictions without including any of such that may be hereafter declared invalid, illegal, void or unenforceable.
5.13 Rescission and Withdrawal Right. Notwithstanding
anything to the contrary contained in (and without limiting any similar provisions of) any of the other Transaction Documents, whenever
any Purchaser exercises a right, election, demand or option under a Transaction Document and the Company does not timely perform its related
obligations within the periods therein provided, then such Purchaser may rescind or withdraw, in its sole discretion from time to time
upon written notice to the Company, any relevant notice, demand or election in whole or in part without prejudice to its future actions
and rights; provided, however, that, in the case of a rescission of an exercise of a Warrant, the applicable Purchaser shall be required
to return any shares of Common Stock subject to any such rescinded exercise notice concurrently with the return to such Purchaser of the
aggregate exercise price paid to the Company for such shares and the restoration of such Purchaser’s right to acquire such shares
pursuant to such Purchaser’s Warrant (including, issuance of a replacement warrant certificate evidencing such restored right).
5.14 Replacement of Securities. If any
certificate or instrument evidencing any Securities is mutilated, lost, stolen or destroyed, the Company shall issue or cause to be issued
in exchange and substitution for and upon cancellation thereof (in the case of mutilation), or in lieu of and substitution therefor, a
new certificate or instrument, but only upon receipt of evidence reasonably satisfactory to the Company of such loss, theft or destruction.
The applicant for a new certificate or instrument under such circumstances shall also pay any reasonable third-party costs (including
customary indemnity) associated with the issuance of such replacement Securities.
5.15 Remedies. In addition to being entitled
to exercise all rights provided herein or granted by law, including recovery of damages, each of the Purchasers and the Company will be
entitled to specific performance under the Transaction Documents. The parties agree that monetary damages may not be adequate compensation
for any loss incurred by reason of any breach of obligations contained in the Transaction Documents and hereby agree to waive and not
to assert in any action for specific performance of any such obligation the defense that a remedy at law would be adequate.
5.16 Payment Set Aside. To the extent that
the Company makes a payment or payments to any Purchaser pursuant to any Transaction Document or a Purchaser enforces or exercises its
rights thereunder, and such payment or payments or the proceeds of such enforcement or exercise or any part thereof are subsequently invalidated,
declared to be fraudulent or preferential, set aside, recovered from, disgorged by or are required to be refunded, repaid or otherwise
restored to the Company, a trustee, receiver or any other Person under any law (including, without limitation, any bankruptcy law, state
or federal law, common law or equitable cause of action), then to the extent of any such restoration the obligation or part thereof originally
intended to be satisfied shall be revived and continued in full force and effect as if such payment had not been made or such enforcement
or setoff had not occurred.
5.17 Independent Nature of Purchasers’
Obligations and Rights. The obligations of each Purchaser under any Transaction Document are several and not joint with the obligations
of any other Purchaser, and no Purchaser shall be responsible in any way for the performance or non-performance of the obligations of
any other Purchaser under any Transaction Document. Nothing contained herein or in any other Transaction Document, and no action taken
by any Purchaser pursuant hereto or thereto, shall be deemed to constitute the Purchasers as a partnership, an association, a joint venture
or any other kind of entity, or create a presumption that the Purchasers are in any way acting in concert or as a group with respect to
such obligations or the transactions contemplated by the Transaction Documents. Each Purchaser shall be entitled to independently protect
and enforce its rights including, without limitation, the rights arising out of this Agreement or out of the other Transaction Documents,
and it shall not be necessary for any other Purchaser to be joined as an additional party in any proceeding for such purpose. Each Purchaser
has been represented by its own separate legal counsel in its review and negotiation of the Transaction Documents. For reasons of administrative
convenience only, each Purchaser and its respective counsel have chosen to communicate with the Company through the Placement Agent Counsel,
the legal counsel of the Placement Agent. Placement Agent Counsel does not represent any of the Purchasers and only represents the Placement
Agent. The Company has elected to provide all Purchasers with the same terms and Transaction Documents for the convenience of the Company
and not because it was required or requested to do so by any of the Purchasers. It is expressly understood and agreed that each provision
contained in this Agreement and in each other Transaction Document is between the Company and a Purchaser, solely, and not between the
Company and the Purchasers collectively and not between and among the Purchasers.
5.18 Saturdays, Sundays, Holidays, etc.
If the last or appointed day for the taking of any action or the expiration of any right required or granted herein shall not be a Business
Day, then such action may be taken or such right may be exercised on the next succeeding Business Day.
5.19 Liquidated Damages. The Company’s
obligations to pay any partial liquidated damages or other amounts owing under the Transaction Documents is a continuing obligation of
the Company and shall not terminate until all unpaid partial liquidated damages and other amounts have been paid notwithstanding the fact
that the instrument or security pursuant to which such partial liquidated damages or other amounts are due and payable shall have been
canceled.
5.20 Construction. The parties agree that
each of them and/or their respective counsel have reviewed and had an opportunity to revise the Transaction Documents and, therefore,
the normal rule of construction to the effect that any ambiguities are to be resolved against the drafting party shall not be employed
in the interpretation of the Transaction Documents or any amendments thereto. In addition, each and every reference to share prices and
shares of Common Stock in any Transaction Document shall be subject to adjustment for reverse and forward stock splits, stock dividends,
stock combinations and other similar transactions relating to shares of Common Stock that occur after the date of this Agreement.
5.21 WAIVER OF JURY TRIAL. IN ANY ACTION, SUIT,
OR PROCEEDING IN ANY JURISDICTION BROUGHT BY ANY PARTY AGAINST ANY OTHER PARTY, THE PARTIES EACH KNOWINGLY AND INTENTIONALLY, TO THE GREATEST
EXTENT PERMITTED BY APPLICABLE LAW, HEREBY ABSOLUTELY, UNCONDITIONALLY, IRREVOCABLY AND EXPRESSLY WAIVES FOREVER TRIAL BY JURY.
[Signature Pages Follow]
IN WITNESS WHEREOF, the parties
hereto have caused this Securities Purchase Agreement to be duly executed by their respective authorized signatories as of the date first
indicated above.
THERIVA BIOLOGICS, INC. |
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[REMAINDER OF PAGE INTENTIONALLY LEFT BLANK.
SIGNATURE PAGES FOR PURCHASERS FOLLOW.]
[PURCHASER SIGNATURE PAGES TO SECURITIES PURCHASE
AGREEMENT]
IN WITNESS WHEREOF, the undersigned
have caused this Securities Purchase Agreement to be duly executed by their respective authorized signatories as of the date first indicated
above.
Name of Purchaser:
Signature of Authorized Signatory of Purchaser:
Name of Authorized Signatory:
Title of Authorized Signatory:
Email Address of Authorized Signatory:
Facsimile Number of Authorized Signatory:
Address for Notice to Purchaser:
Address for Delivery of Warrant Shares to the
Purchaser (if not same address for notice):
DWAC for Common Stock:
Subscription Amount: $___________________
Shares of Common Stock: ___________________
Shares of Common Stock underlying the Pre-Funded
Warrants: ________
Warrant Shares underlying the Common Warrants:
________
EIN Number: ___________________
¨
Notwithstanding anything contained in this Agreement to the contrary, by checking this box (i) the obligations of the above-signed
to purchase the securities set forth in this Agreement to be purchased from the Company by the above-signed, and the obligations of the
Company to sell such securities to the above-signed, shall be unconditional and all conditions to Closing shall be disregarded, (ii) the
Closing shall occur on the second (2nd) Trading Day following the date of this Agreement and (iii) any condition to Closing contemplated
by this Agreement (but prior to being disregarded by clause (i) above) that required delivery by the Company or the above-signed
of any agreement, instrument, certificate or the like or purchase price (as applicable) shall no longer be a condition and shall instead
be an unconditional obligation of the Company or the above-signed (as applicable) to deliver such agreement, instrument, certificate or
the like or purchase price (as applicable) to such other party on the Closing Date.
[SIGNATURE PAGES CONTINUE]
Exhibit A
Form of Common Warrant
(See Attached)
Exhibit B
Form of Pre-Funded Warrant
(See Attached)
Exhibit C
Form of Lock-Up Agreement
(See Attached)
29
Exhibit 23.1
Consent of Independent Registered
Public Accounting Firm
We hereby consent to the incorporation by reference
in the Prospectus constituting a part of this Registration Statement of our report dated March 25, 2024, relating to the consolidated
financial statements of Theriva Biologics, Inc. (the Company) appearing in the Company’s Annual Report on Form 10-K for the year
ended December 31, 2023. Our report contains an explanatory paragraph regarding the Company’s ability to continue as a going concern.
We also consent to the reference
to us under the caption “Experts” in the Prospectus.
/s/ BDO USA, P.C.
Raleigh, North Carolina
January 21, 2025
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