Filed
Pursuant to Rule 424(b)(5)
Registration No. 333-258756
The
information in this preliminary prospectus supplement is not complete and may be changed. A registration statement relating to these
securities has been filed with the Securities and Exchange Commission and is effective. This preliminary prospectus supplement and the
accompanying prospectus are not an offer to sell these securities and they are not soliciting an offer to buy these securities in any
jurisdiction where the offer or sale thereof is not permitted.
Subject to Completion,
dated June 28, 2023
Preliminary
Prospectus Supplement
(To prospectus dated August 20, 2021)
CorMedix
Inc.
Shares
of Common Stock and
Pre-Funded Warrants to
Purchase Up to
Shares of Common Stock
Shares of Common Stock Underlying the Pre-Funded Warrants
We are offering
shares of our common stock and, in lieu of common stock to certain investors, pre-funded warrants to purchase up to an aggregate of
shares
of common stock (the “pre-funded warrants”). The purchase price of each pre-funded warrant will equal the price per share
at which shares of our common stock are being sold to the public in this offering, minus $0.0001, which is the exercise price of each
pre-funded warrant. This prospectus supplement also relates to the offering of the shares of common stock issuable upon exercise of the
pre-funded warrants.
Our common stock is listed on the Nasdaq Global
Market under the symbol “CRMD.” On June 27, 2023, the last reported sale price of our common stock on the Nasdaq Global Market
was $4.97 per share. We do not intend to list the pre-funded warrants on the Nasdaq Global Market, any other national securities exchange
or any other nationally recognized trading system.
Investing in our common stock or pre-funded
warrants involves risks. See “Risk Factors” beginning on page S-3 of this prospectus supplement and the risks discussed under
similar headings in the documents incorporated by reference into this prospectus supplement and the accompanying prospectus, and any free
writing prospectus that we have authorized for use in connection with this offering.
Neither
the Securities and Exchange Commission nor any state securities commission has approved or disapproved of these securities or passed
upon the accuracy or adequacy of this prospectus supplement or accompanying prospectus. Any representation to the contrary is a criminal
offense.
| | |
Per
Share | | |
Per Pre-Funded Warrant | | |
Total | |
| Public Offering Price | |
$ | | | |
$ | | | |
$ | | |
| Underwriting Discounts and Commissions(1) | |
$ | | | |
$ | | | |
$ | | |
| Proceeds, before expenses, to us | |
$ | | | |
$ | | | |
$ | | |
| (1) | We have agreed to reimburse the underwriters for certain expenses.
We refer you to “Underwriting” beginning on page S-9 for additional information regarding total underwriting compensation. |
We have granted the underwriters an option for a period of 30 days
to purchase additional shares of our common
stock. If the underwriters exercise the option in full, the total underwriting discounts and commissions payable by us will be $ , and
the total proceeds to us, before expenses, will be $ .
Delivery of the shares of common stock and pre-funded
warrants is expected to be made on or about , 2023.
| |
Book-Running Managers |
|
| |
|
|
| RBC
Capital Markets |
Truist
Securities |
JMP Securities
A CITIZENS
COMPANY |
The
date of this prospectus supplement is , 2023.
TABLE OF CONTENTS
Prospectus
Supplement
Prospectus
Neither
we nor the underwriters have authorized anyone to provide you with any information other than the information contained in this prospectus
supplement and the accompanying prospectus, including the documents incorporated by reference herein and therein, and any free writing
prospectus we have authorized for use in connection with this offering. We take no responsibility for, and can provide no assurances
as to the reliability of, any other information that others may give you. You should not assume that the information contained in this
prospectus supplement, the accompanying prospectus, the documents incorporated by reference herein or therein, and in any free writing
prospectus that we have authorized for use in connection with this offering is accurate as of any date other than the date of those respective
documents. Our business, financial condition, liquidity, results of operations and prospects may have changed since those dates. You
should read this prospectus supplement, the accompanying prospectus, the documents incorporated by reference herein and therein, and
any free writing prospectus that we have authorized for use in connection with this offering in their entirety before making an investment
decision. You should also read and consider the information in the documents to which we have referred you in the sections of this prospectus
supplement titled “Where You Can Find More Information” and “Incorporation of Documents by Reference.”
For
investors outside of the United States: We are not, and the underwriters are not, making offers to sell these securities in any jurisdiction
in which an offer or solicitation is not authorized or permitted or in which the person making such offer or solicitation is not qualified
to do so or to any person to whom it is unlawful to make such an offer or solicitation.
ABOUT
THIS PROSPECTUS SUPPLEMENT
This prospectus supplement is part of the registration
statement that we filed with the Securities and Exchange Commission (the “SEC”) using a “shelf” registration process
pursuant to which we may, from time to time, sell common stock, pre-funded warrants or other securities, of which this offering is a part.
This document consists of two parts. The first part is this prospectus supplement, including the documents incorporated by reference,
which describes the specific terms of this offering and also adds to and updates the information contained in the accompanying prospectus
and the documents incorporated by reference therein. The second part, the accompanying prospectus, including the documents incorporated
by reference, gives more general information, some of which may not apply to this offering. Generally, when we refer to the “prospectus,”
we are referring to both parts combined. This prospectus supplement and any free writing prospectus we authorize for use in connection
with this offering may add to, update or change information in the accompanying prospectus and the documents incorporated by reference
into this prospectus supplement or the accompanying prospectus.
If information in this prospectus supplement is
inconsistent with information contained in the accompanying prospectus or in any document incorporated by reference herein or therein
that was filed with the SEC before the date of this prospectus supplement, the information in this prospectus supplement will be deemed
to modify or supersede the information contained in the accompanying prospectus and such documents incorporated by reference herein or
therein. This prospectus supplement, the accompanying prospectus, the documents incorporated by reference into each and any free writing
prospectus we authorize for use in connection with this offering include important information about us, the shares of our common stock
and pre-funded warrants and other information you should consider before purchasing the shares of our common stock or pre-funded warrants.
See “Where You Can Find More Information” and “Incorporation of Documents by Reference” in this prospectus supplement
for additional information.
This prospectus supplement and accompanying prospectus
do not constitute an offer to sell or the solicitation of an offer to buy any securities other than the securities described in this prospectus
supplement and accompanying prospectus or an offer to sell or the solicitation of an offer to buy such securities in any circumstances
in which such offer or solicitation is unlawful. Persons outside the United States who come into possession of this prospectus supplement
and the accompanying prospectus must inform themselves about, and observe any restrictions relating to, the offering of the common stock
and the pre-funded warrants and the distribution of this prospectus supplement and accompanying prospectus outside the United States.
We
further note that the representations, warranties and covenants made by us in any agreement that is filed as an exhibit to any document
that is incorporated by reference herein were made solely for the benefit of the parties to such agreement, including, in some cases,
for the purpose of allocating risk among the parties to such agreements, and should not be deemed to be a representation, warranty or
covenant to you. Moreover, such representations, warranties and covenants were accurate only as of the date when made. Accordingly, such
representations, warranties and covenants should not be relied on as accurately representing the current state of our affairs.
When
we refer to “CorMedix,” “Company,” “we,” “our” and “us” in this prospectus
supplement and accompanying prospectus, we mean CorMedix Inc. and its consolidated subsidiaries, unless otherwise specified.
Neutrolin®
is our registered trademark. DefenCath™ and CorMedix Inc. are our filed trademarks. All other trade names, trademarks and service
marks appearing in this prospectus supplement are the property of their respective owners. We have assumed that the reader understands
that all such terms are source-indicating. Accordingly, such terms, when first mentioned in this prospectus supplement, appear with the
trade name, trademark or service mark notice and then throughout the remainder of this prospectus supplement without trade name, trademark
or service mark notices for convenience only and should not be construed as being used in a descriptive or generic sense.
CAUTIONARY
NOTICE REGARDING FORWARD-LOOKING STATEMENTS
This prospectus supplement and the accompanying
prospectus, including the documents that we incorporate by reference, contain “forward-looking statements” that involve risks
and uncertainties, as well as assumptions that, if they never materialize or prove incorrect, could cause our results to differ materially
from those expressed or implied by such forward-looking statements. The statements contained in this prospectus supplement that are not
purely historical are forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended (the “Securities
Act”), and Section 21E of the Securities Exchange Act of 1934, as amended (the “Exchange Act”). Forward-looking statements
are often identified by the use of words such as, but not limited to, “anticipate,” “believe,” “can,”
“continue,” “could,” “estimate,” “expect,” “intend,” “may,” “will,”
“plan,” “project,” “seek,” “should,” “target,” “will,” “would,”
and similar expressions or variations intended to identify forward-looking statements, which may include, but are not limited to, statements
concerning the following:
| ● | We
have a history of operating losses, may incur additional operating losses in the future and
may not achieve profitability when expected or we may never be profitable. |
| ● | Our
expectation regarding the sufficiency of the proceeds from this offering together with our
existing cash, cash equivalents, short-term investments and available resources to fund the
anticipated launch of DefenCath through anticipated profitability. |
| ● | Our
ability to generate revenue from anticipated future product sales, and our ability to achieve
and maintain profitability. |
| ● | Our
cost of operations could increase significantly more than what we expect depending on the
costs to complete our development program for DefenCath/Neutrolin. |
| ● | We
may need to finance our future cash needs through public or private equity offerings, debt
financings or corporate collaboration and licensing arrangements. Any additional funds that
we obtain may not be on terms favorable to us or our stockholders and may require us to relinquish
valuable rights. |
| ● | DefenCath,
our lead product candidate, has received Fast Track designation and Qualified Infectious
Disease Product designation from the FDA, but we cannot provide assurances that these designations
will not be rescinded. |
| ● | If
the FDA requires a second clinical trial for DefenCath, the development of DefenCath will
take longer and cost more to complete, and we will likely need significant additional funds
to undertake a second trial, if required. |
| ● | Final
approval by regulatory authorities of DefenCath or our other product candidates for commercial
use may be delayed, limited or prevented, any of which would adversely affect our ability
to generate operating revenues. |
| ● | Successful
development and commercialization of our other products is uncertain. |
| ● | If
we or our collaborators are unable to manufacture our products in sufficient quantities or
are unable to obtain regulatory approvals for a manufacturing facility, we may be unable
to meet demand for our products and we may lose potential revenues. |
| ● | The
successful commercialization of DefenCath will depend on obtaining coverage and reimbursement
from third-party payors, and physicians and patients may not accept and use our products. |
| ● | If
we fail to comply with environmental, health and safety laws and regulations, we could become
subject to fines or penalties or incur costs that could harm our business. |
| ● | Clinical
trials required for our product candidates may be expensive and time-consuming, and their
outcome is uncertain. |
| ● | If
we fail to comply with international regulatory requirements, we could be subject to regulatory
delays, fines or other penalties. |
| ● | Even
if approved, our products will be subject to extensive post-approval regulation. |
| ● | Competition
and technological change may make our product candidates and technologies less attractive
or obsolete. |
| ● | Healthcare
policy changes, including reimbursement policies for drugs and medical devices, may have
an adverse effect on our business, financial condition and results of operations. |
| ● | If
we lose key management or scientific personnel, cannot recruit qualified employees, directors,
officers, or other personnel or experience increases in compensation costs, our business
may materially suffer. |
| ● | We
may not successfully manage our growth. |
| ● | We
face the risk of product liability claims and the amount of insurance coverage we hold now
or in the future may not be adequate to cover all liabilities we might incur, and we may
be exposed to liability claims associated with the use of hazardous materials and chemicals. |
| ● | Negative
U.S. and global economic conditions may pose challenges to our business strategy, which relies
on funding from the financial markets or collaborators. |
| ● | If
we materially breach or default under any of our license agreements, the licensor party to
such agreement will have the right to terminate the license agreement, which termination
may materially harm our business. |
| ● | If
we and our licensors do not obtain protection for and successfully defend our respective
intellectual property rights, competitors may be able to take advantage of our research and
development efforts to develop competing products. |
| ● | Ongoing
and future intellectual property disputes could require us to spend time and money to address
such disputes and could limit our intellectual property rights. |
| ● | The
decisions by the European and German patent offices may affect patent rights in other jurisdictions. |
| ● | If
we infringe the rights of third parties we could be prevented from selling products and forced
to pay damages and defend against litigation. |
| ● | We
may seek a sales partner in the U.S. if DefenCath receives FDA approval or we may undertake
marketing and sales of DefenCath in the U.S. on our own. If we are unable to enter into or
maintain agreements with third parties to market and sell DefenCath or any other product
after approval or are unable to find a sales partner or establish our own marketing and sales
capabilities, we may not be able to generate significant or any product revenues. |
| ● | Corporate
and academic collaborators may take actions that delay, prevent, or undermine the success
of our products. |
| ● | Data
provided by collaborators and others upon which we rely that has not been independently verified
could turn out to be false, misleading or incomplete. |
| ● | We
rely on third parties to conduct our clinical trials and pre-clinical studies. If those parties
do not successfully carry out their contractual duties or meet expected deadlines, our product
candidates may not advance in a timely manner or at all. |
| ● | We
will depend on third party suppliers and contract manufacturers for the manufacturing of
our product candidates and have no direct control over the cost of manufacturing our product
candidates. Increases in the cost of manufacturing our product candidates would increase
our costs of conducting clinical trials and could adversely affect our future profitability. |
| ● | We
may need additional financing to fund our activities in the future, which may dilute our
stockholders. |
| ● | Our
executive officers and directors may sell shares of their stock, and these sales could adversely
affect our stock price. |
| ● | Our
common stock price has fluctuated considerably and is likely to remain volatile, in part
due to the limited market for our common stock and you could lose all or a part of your investment. |
| ● | A
significant number of additional shares of our common stock may be issued at a later date,
and their sale could depress the market price of our common stock. |
| ● | Provisions
in our corporate charter documents and under Delaware law could make an acquisition of us,
which may be beneficial to our stockholders, more difficult. |
| ● | If
we fail to comply with the continued listing standards of the Nasdaq Global Market, it may
result in a delisting of our common stock from the exchange. |
| ● | Laws,
rules and regulations relating to public companies may be costly and impact our ability to attract and retain directors and executive
officers. |
| ● | Our
internal control over financial reporting and our disclosure controls and procedures may not prevent all possible errors that could occur. |
| ● | Security
breaches and other disruptions could compromise our information and expose us to liability, which would cause our business and reputation
to suffer. |
| ● | We
do not intend to pay dividends on our common stock so any returns on our common stock will be limited to the value of our common stock. |
You
should not rely upon forward-looking statements as predictions of future events. Such statements are based on management’s expectations
as of the date of this prospectus supplement and involve many risks and uncertainties that could cause our actual results, events or
circumstances to differ materially from those expressed or implied in our forward-looking statements. Such risks and uncertainties include
those described throughout this prospectus supplement and particularly in the section titled “Risk Factors” and elsewhere
in this prospectus supplement and the documents incorporated by reference herein, including in our Annual Report on Form 10-K for the
fiscal year ended December 31, 2022 and other filings made from time to time with the SEC. Given these risks and uncertainties, readers
are cautioned not to place undue reliance on such forward-looking statements. Readers are urged to carefully review and consider all
of the information in this prospectus supplement, including the documented incorporated by reference herein, the accompanying prospectus,
including the documents incorporated by reference therein, and any free writing prospectus that we have authorized for use in connection
with this offering. We undertake no obligation to update any forward-looking statements made in this prospectus supplement to reflect
events or circumstances after the date of this filing or to reflect new information or the occurrence of unanticipated events, except
as required by law. We may not actually achieve the plans, intentions or expectations disclosed in our forward-looking statements. Our
forward-looking statements do not reflect the potential impact of any future acquisitions, mergers, dispositions, joint ventures or investments
we may make.
PROSPECTUS
SUPPLEMENT SUMMARY
This
summary highlights certain information about us, this offering and selected information contained elsewhere in or incorporated by reference
into this prospectus supplement or the accompanying prospectus. This summary is not complete and does not contain all of the information
that you should consider before deciding whether to invest in our common stock. For a more complete understanding of our Company and
this offering, we encourage you to read and consider carefully the more detailed information in this prospectus supplement and the accompanying
prospectus, including the information incorporated by reference in this prospectus supplement and the accompanying prospectus, and the
information included in any free writing prospectus that we have authorized for use in connection with this offering, including the information
under the heading “Risk Factors” in this prospectus supplement on page S-3, the financial statements and related notes, and
the other information that we incorporate by reference into this prospectus supplement, including the section “Risk Factors”
in our Annual Report on Form 10-K for the year ended December 31, 2022.
Overview
We
are a biopharmaceutical company focused on developing and commercializing therapeutic products for the prevention and treatment of life-threatening
diseases and conditions. Our primary focus is on the development of our lead product candidate, DefenCath™, for potential commercialization
in the United States, or U.S., and other key markets. We have in-licensed the rights to develop and commercialize DefenCath and Neutrolin®.
DefenCath is a novel anti-infective solution (a formulation of taurolidine 13.5 mg/mL, and heparin 1000 USP Units/mL) intended for the
reduction and prevention of catheter-related infections and thrombosis in patients requiring central venous catheters, or CVCs, in clinical
settings such as hemodialysis, total parenteral nutrition and oncology. Infections and thrombosis represent key complications among hemodialysis,
total parenteral nutrition and cancer patients with CVCs. These complications can lead to treatment delays and increased costs to the
healthcare system when they occur due to hospitalizations, need for IV antibiotic treatment, long-term anticoagulation therapy, removal/replacement
of the CVC, related treatment costs, as well as increased mortality. We believe DefenCath, if approved, will address a significant unmet
medical need and a potential large market opportunity. The name DefenCath is the U.S. proprietary name conditionally approved by the
U.S. Food and Drug Administration, or FDA, while the name Neutrolin was used in the European Union, or EU, and other territories where
we received CE-Mark approval for the commercial distribution of Neutrolin as a catheter lock solution, or CLS, regulated as a medical
device.
Recent
Developments
On
June 21, 2023, we issued a press release announcing that the resubmission of the New Drug Application for DefenCath for the reduction
of catheter-related bloodstream infections in patients with kidney failure receiving chronic hemodialysis through a CVC has been accepted
for filing by the FDA. We further announced that the FDA considers the resubmission as a complete Class 2 response with a six-month review
and has assigned a Prescription Drug User Fee Act target action date of November 15, 2023.
Corporate
Information
Our
principal executive offices are located at 300 Connell Drive, Suite 4200, Berkeley Heights, New Jersey 07922. Our telephone number is
(908) 517-9500, and our website address is www.cormedix.com. The website and the information contained therein or connected thereto are
not incorporated into this prospectus supplement. Our common stock is listed on the Nasdaq Global Market under the symbol “CRMD.”
This
prospectus supplement and all of our filings under the Exchange Act, including copies of Annual Reports on Form 10-K, Quarterly Reports
on Form 10-Q, Current Reports on Form 8-K, and any amendments to those reports, are available free of charge through our website on the
date we file those materials with, or furnish them to, the SEC. Such filings are also available to the public on the SEC’s website
at www.sec.gov.
THE
OFFERING
| Common stock offered
by us |
shares of our common stock and pre-funded warrants to purchase shares of our common stock. |
| |
|
| Pre-funded warrants offered by us |
We are also offering, in lieu of common stock to certain
investors, pre-funded warrants to purchase shares of our common stock. The purchase price of each pre-funded warrant equals the
price per share at which the shares of our common stock are being sold to the public in this offering, minus $0.0001, which is the
exercise price of each pre-funded warrant per share. Each pre-funded warrant will be exercisable at any time after the date of
issuance of such pre-funded warrant, subject to an ownership limitation. See “Description of Pre-funded Warrants.” This
prospectus supplement also relates to the offering of the shares of our common stock issuable upon exercise of the pre-funded
warrants. |
| |
|
| Underwriters’
option to purchase additional shares of common stock |
The underwriters have an option to purchase a maximum of additional
shares of common stock from us. The underwriters can exercise this option at any time within 30 days from the date of this prospectus
supplement. |
| |
|
| Common stock
to be outstanding immediately after the offering |
shares (or shares
if the underwriters exercise in full their option to purchase additional shares of common stock). |
| |
|
| Use of proceeds |
We intend to use the net proceeds from this offering for
general corporate purposes, commercialization efforts, research and development, and working capital and general expenditures. See
“Use of Proceeds” on page S-5 for additional information. |
| |
|
| Risk factors |
See “Risk Factors” beginning on page S-3 of this prospectus
supplement and the other information included in, or incorporated by reference into, this prospectus supplement for a discussion of certain
factors you should carefully consider before deciding to invest in shares of our common stock or pre-funded warrants. |
| |
|
| Nasdaq Global
Market symbol |
“CRMD”. There is no established trading market for the
pre-funded warrants, 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 other trading market. Without a trading market, the liquidity of the pre-funded warrants will be extremely limited. |
Except
as otherwise indicated, all information in this prospectus supplement is based upon 44,499,788 shares of our common stock outstanding
as of March 31, 2023, and excludes:
| ● | 6,126,080
shares of our common stock issuable upon exercise of stock options outstanding as of March
31, 2023 having a weighted-average exercise price of $5.70 per share; |
| ● | 207,469
shares of our common stock issuable upon the settlement of outstanding restricted stock units
as of March 31, 2023; |
| ● | 48,909
shares of our common stock issuable for payment of deferred board compensation as of March
31, 2023; |
| ● | 4,000
shares of Series C non-voting convertible preferred stock issued and outstanding as of March 31, 2023; |
| ● | 391,953
shares of Series E voting convertible preferred stock issued and outstanding as of March 31, 2023;
and |
| ● | 5,004,069
shares of Series G voting convertible preferred stock issued and outstanding as of March 31, 2023. |
Except as otherwise indicated, all information
in this prospectus supplement assumes no exercise or settlement of outstanding options or restricted stock units after March 31, 2023,
no exercise of the underwriters’ option to purchase additional shares of common stock, and no exercise of pre-funded warrants
in this offering.
RISK
FACTORS
Investing
in our common stock or pre-funded warrants involves risk. Before deciding whether to invest in our common stock or pre-funded warrants,
you should consider carefully the risks and uncertainties described below. You should also consider the risks, uncertainties and assumptions
discussed under the heading “Risk Factors” included in our most recent Annual Report on Form 10-K, which are on file with
the SEC and incorporated herein by reference, and which may be amended, supplemented or superseded from time to time by other reports
we file with the SEC in the future. There may be other unknown or unpredictable economic, business, competitive, regulatory or other
factors that could have material adverse effects on our future results. If any of these risks actually occurs, our business, business
prospects, financial condition or results of operations could be seriously harmed. This could cause the trading price of our common stock
and the value of our pre-funded warrants to decline, resulting in a loss of all or part of your investment. Please also read carefully
the section above titled “Cautionary Statement Regarding Forward-Looking Statements.”
Risks
Related to Our Common Stock and This Offering
Our share price may be volatile, and you may
be unable to sell your shares of common stock at or above the offering price.
The
market price of our common stock is likely to be volatile and could be subject to wide fluctuations in response to many risk factors
listed in this section or incorporated by reference herein, and others beyond our control.
Furthermore,
the stock markets have experienced price and volume fluctuations that have affected and continue to affect the market prices of equity
securities of many companies. These fluctuations often have been unrelated or disproportionate to the operating performance of those
companies. These broad market and industry fluctuations, as well as general economic, political and market conditions such as recessions,
interest rate changes or international currency fluctuations, may negatively impact the market price of our common stock. If the market
price of our common stock after this offering does not exceed the public offering price, you may not realize any return on your investment
in us and may lose some or all of your investment. In the past, companies that have experienced volatility in the market price of their
stock have been subject to securities class action litigation. We may be the target of this type of litigation in the future. Securities
litigation against us could result in substantial costs and divert our management’s attention from other business concerns, which
could seriously harm our business.
Purchasers
of shares of our common stock in this offering will experience immediate and substantial dilution in the book value of their investment.
If you purchase shares of our common stock
in this offering, you will incur immediate and substantial dilution in the as adjusted net tangible book value of your stock of $
per share, based on the public offering price of $ per share, because offering
price per share in this offering may exceed the net tangible book value per share of our common stock outstanding prior to this
offering, assuming no exercise of the pre-funded warrants. To the extent we raise additional capital by issuing equity securities,
our stockholders will experience substantial additional dilution. The exercise of outstanding stock options and warrants may result
in further dilution of your investment. Additionally, because the sales of shares of our common stock offered hereby will be made
directly into the market, the prices at which we sell such securities will vary and these variations may be significant. As a
result, you may suffer dilution if you purchase shares in this offering at a higher price than other shares offered hereby are sold.
See the section entitled “Dilution” below for a more detailed illustration of the dilution you would incur if you
participate in this offering.
We
have broad discretion in the use of the net proceeds from this offering and our existing cash and may not use them effectively.
Our
management will have broad discretion in the application of the net proceeds from this offering, including for any of the purposes described
in the section titled “Use of Proceeds,” as well as our existing cash and cash equivalents, and you will be relying on the
judgment of our management regarding such application. You will not have the opportunity, as part of your investment decision, to assess
whether the net proceeds are being used appropriately. This expected use of the net proceeds from this offering represents our intentions
based upon our current plans and business conditions. The amounts and timing of our actual expenditures may vary significantly depending
on numerous factors, including the progress of our development efforts, the status of and results from clinical trials, as well as any
collaborations that we may enter into with third parties for our product candidates, and any unforeseen cash needs. Because of the number
and variability of factors that will determine our use of the net proceeds from this offering, their ultimate use may vary substantially
from their currently intended use. Our management might not apply the net proceeds or our existing cash in ways that ultimately increase
the value of your investment. If we do not invest or apply the net proceeds from this offering or our existing cash and cash equivalents
in ways that enhance stockholder value, we may fail to achieve expected business and financial results, which could cause our stock price
to decline. Pending their use, we may invest the net proceeds from this offering in short-term, investment-grade, interest-bearing securities.
These investments may not yield a favorable return to our stockholders.
Future
sales of our common stock in the public market, or the perception that such sales could occur, could cause our stock price to fall.
The
sale of a substantial number of shares of our common stock or other equity-related securities in the public markets, or the perception
that such sales could occur, could depress the market price of our common stock and impair our ability to raise capital through the sale
of additional equity securities. We may sell large quantities of our common stock at any time pursuant to this prospectus supplement
or in one or more separate offerings. We cannot predict the effect that future sales of common stock or other equity-related securities
would have on the market price of our common stock.
There is no public market for the pre-funded
warrants being offered in this offering.
There is no established trading market for the
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 pre-funded warrants on any securities exchange or nationally recognized trading system, including the Nasdaq Global Market. Without
an active market, the liquidity of the pre-funded warrants will be limited.
Holders of pre-funded warrants purchased in
this offering will have no rights as holders of our common stock with respect to the shares of common stock underlying such pre-funded
warrants until such holders exercise their pre-funded warrants and acquire our common stock, except as provided in the pre-funded warrants.
Until holders of the pre-funded warrants being
offered in this offering acquire shares of our common stock upon exercise of such pre-funded warrants, the holders will have no rights
with respect to the shares of our common stock underlying such pre-funded warrants. Upon exercise of the pre-funded warrants, the holders
will be entitled to exercise the rights of a common stockholder only as to matters for which the record date occurs after the exercise.
We may not receive any additional funds upon
the exercise of the pre-funded warrants.
Each pre-funded warrant may be exercised by way
of a cashless exercise, 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 our common stock determined according to the formula set forth in the pre-funded warrant. Accordingly, we
may not receive any additional funds upon the exercise of the pre-funded warrants.
Significant holders or beneficial holders of
our common stock may not be permitted to exercise pre-funded warrants that they hold.
A holder of a pre-funded warrant will not be entitled
to exercise any portion of any pre-funded warrant which, upon giving effect to such exercise, would cause the aggregate number of shares
of our common stock beneficially owned by the holder (together with its affiliates) to exceed 4.99% of the number of shares of our common
stock outstanding immediately after giving effect to the exercise. Such percentage may be increased by the holder of the pre-funded warrant
to any other percentage not in excess of 4.99% upon at least 61 days’ prior notice from the holder to us. As a result, you may not
be able to exercise your pre-funded warrants for shares of our common stock at a time when it would be financially beneficial for you
to do so. In such circumstance you could seek to sell your pre-funded warrants to realize value, but you may be unable to do so in the
absence of an established trading market for the pre-funded warrants.
Our internal control over financial reporting
and our disclosure controls and procedures may not prevent all possible errors that could occur.
Our management is responsible for establishing and
maintaining adequate internal control over financial reporting to provide reasonable assurance regarding the reliability of our financial
reporting and the preparation of financial statements for external purposes in accordance with accounting principles generally accepted
in the United States of America (“U.S. GAAP”). Ensuring that we have adequate internal financial and accounting controls and
procedures in place to produce accurate financial statements on a timely basis is a costly and time-consuming effort that needs to be
re-evaluated frequently. Failure on our part to have effective internal financial and accounting controls would cause our financial reporting
to be unreliable, could have a material adverse effect on our business, operating results, and financial condition, and could cause the
trading price of our common stock to fall dramatically. In June 2023, our registered public accounting firm agreed to a settlement with
the SEC with respect to certain matters relating to systemic quality control failures and violations of audit standards in connection
with audit work for hundreds of special purpose acquisition company (SPAC) clients beginning at the latest in 2020 and continuing through
2022. We are actively monitoring the situation but do not currently believe this settlement will affect CorMedix or our financial statements.
A control system, no matter how well designed and operated, can provide
only reasonable, not absolute, assurance that the control system’s objectives will be satisfied. Internal control over financial
reporting and disclosure controls and procedures are designed to give a reasonable assurance that they are effective to achieve their
objectives. We cannot provide absolute assurance that all of our possible future control issues will be detected. These inherent limitations
include the possibility that judgments in our decision making can be faulty, and that isolated breakdowns can occur because of simple
human error or mistake. The design of our system of controls is based in part upon assumptions about the likelihood of future events,
and there can be no assurance that any design will succeed absolutely in achieving our stated goals under all potential future or unforeseeable
conditions. Because of the inherent limitations in a cost-effective control system, misstatements due to error could occur and not be
detected. This and any future failures could cause investors to lose confidence in our reported financial information, which could have
a negative impact on our financial condition and stock price.
In future periods, if the process required by Section 404 of the Sarbanes-Oxley
Act reveals any material weaknesses or significant deficiencies, the correction of any such material weaknesses or significant deficiencies
could require remedial measures which could be costly and time-consuming. In addition, in such a case, we may be unable to produce accurate
financial statements on a timely basis. Any associated accounting restatement could create a significant strain on our internal resources
and cause delays in our release of quarterly or annual financial results and the filing of related reports, increase our costs and cause
management distraction. Any of the foregoing could cause investors to lose confidence in the reliability of our financial statements,
which could cause the market price of our common stock to decline and make it more difficult for us to finance our operations and growth.
USE
OF PROCEEDS
We estimate that the net proceeds from the sale
of the shares of common stock and pre-funded warrants that we are selling in this offering, after deducting the underwriting discounts
and commissions and estimated offering expenses payable by us, will be approximately $ million, or approximately $ million if the underwriters
exercise in full their option to purchase up to
additional shares of common stock. We will receive nominal proceeds, if any, upon exercise of the pre-funded warrants.
We
intend to use the net proceeds from this offering for general corporate purposes, commercialization efforts, research and development,
and working capital and general expenditures.
We believe that the net proceeds from this offering,
together with our existing cash, cash equivalents, short-term investments and available resources, will enable us to fund the launch of
DefenCath through to anticipated profitability, which could occur as early as the end of 2024. These estimates are based upon the assumption
of an approval of the DefenCath NDA in November 2023, commercial launch in the first quarter of 2024, and other base case assumptions
for market penetration, average selling price, R&D expense and commercial infrastructure cost. This expected use of the net proceeds
from this offering represents our intentions based upon our current plans and business conditions, which could change in the future as
our plans and business conditions evolve. As of the date of this prospectus supplement, we cannot predict with certainty all of the particular
uses for the proceeds to be received upon the completion of this offering, the actual amounts that we will spend on the uses set forth
above, nor can we guarantee that the Company will achieve profitability as early as the end of 2024 or at all. As a result, our management
will retain broad discretion over the allocation of the net proceeds from this offering.
Pending
the application of the net proceeds as set forth above, we intend to invest the net proceeds in short-term, interest-bearing, investment-grade
securities.
DIVIDEND
POLICY
We
have never declared dividends on our equity securities, and currently do not plan to declare dividends on shares of our common stock
in the foreseeable future. We expect to retain our future earnings, if any, for use in the operation and expansion of our business. Further,
pursuant to the terms of our Series C-3 Non-Voting Convertible Preferred Stock, Series E and G Voting Convertible Preferred Stock, we
may not declare or pay any dividends or make any distributions on any of our shares or other equity securities as long as any of those
preferred shares remain outstanding. Subject to the foregoing, the payment of cash dividends in the future, if any, will be at the discretion
of our board of directors and will depend upon such factors as earnings levels, capital requirements, our overall financial condition
and any other factors deemed relevant by our board of directors.
DILUTION
If you invest in our common stock and pre-funded
warrants in this offering, your ownership interest will be diluted to the extent of the difference between the public offering price per
share of our common stock or issuable upon the exercise of the pre-funded warrants and the as-adjusted net tangible book value per share
of our common stock immediately after this offering. We calculate net tangible book value per share by dividing the net tangible book
value (our tangible assets less our total liabilities) by the number of outstanding shares of our common stock.
The historical net tangible book value of our
common stock as of March 31, 2023 was $53.9 million, or $1.21 per share, based on 44,499,788 shares of common stock outstanding as of
March 31, 2023.
After giving effect to the sale of
shares of our common stock in this offering at the public offering price of $ per share and
pre-funded warrants to purchase shares of our common stock at the public offering price of $ per pre-funded warrant (which equals
the public offering price per share of our common stock less the $0.0001 per share exercise price of each such pre-funded warrants
or any resulting accounting associated with the pre-funded warrants), and after deducting estimated underwriting discounts and
commissions and offering expenses, our as-adjusted net tangible book value as of March 31, 2023 would have been $ million, or $ per
share. This represents an immediate increase in the as-adjusted net tangible book value of $ per share to existing stockholders and
an immediate dilution in the as-adjusted net tangible book value of $ per share to new investors purchasing shares of our common
stock in this offering.
The following table illustrates the dilution,
assuming the underwriters do not exercise their option to purchase additional shares of common stock and the holders of the pre-funded
warrants offered hereby do not exercise the pre-funded warrants:
| Public offering price per share | |
| | | |
$ | | |
| Historical net tangible book value per share as of March 31, 2023 | |
$ | 1.21 | | |
| | |
| Increase in net tangible book value per share attributable to new investors | |
$ | | | |
| | |
| As adjusted net tangible book value per share after giving effect to this offering | |
| | | |
$ | | |
| Dilution per share to new investors participating in this offering | |
| | | |
$ | | |
If the underwriters exercise their option to
purchase additional shares of our common stock in full at the public offering price
of per share (and excluding shares of our common stock
issued and any proceeds received upon exercise of the pre-funded warrants or any resulting accounting associated with the pre-funded
warrants), and after deducting estimated underwriting discounts and commissions and offering expenses payable by us, the as-adjusted
net tangible book value would be approximately $ per share, representing an immediate increase in the as-adjusted net tangible book
value of approximately $ per share to existing stockholders and an immediate dilution in the as-adjusted net tangible book value of
per share to new investors purchasing shares of our common stock in this offering.
The
foregoing calculations exclude the following shares as of March 31, 2023:
| ● | 6,126,080
shares of our common stock issuable upon exercise of stock options outstanding as of March
31, 2023 having a weighted-average exercise price of $5.70 per share; |
| ● | 207,469
shares of our common stock issuable upon the settlement of outstanding restricted stock units
as of March 31, 2023; |
| ● | 48,909
shares of our common stock issuable for payment of deferred board compensation as of March
31, 2023; |
| ● | 4,000 shares of Series C non-voting convertible preferred stock issued
and outstanding as of March 31, 2023; |
| ● | 391,953 shares of Series E voting convertible preferred stock issued
and outstanding as of March 31, 2023; and |
| ● | 5,004,069
shares of Series G voting convertible preferred stock issued and outstanding as of March 31, 2023. |
To the extent that any options are exercised,
new options are issued or we otherwise issue additional shares of common stock in the future at a price less than the public offering
price, there may be further dilution to purchasers of our common stock in this offering. The number of shares of our common stock to be
outstanding after this offering does not take into account the shares of our common stock issuable upon the exercise of the pre-funded
warrants.
DESCRIPTION OF PRE-FUNDED WARRANTS
The following is a brief summary of certain terms and conditions of
the pre-funded warrants being offered by us, which is subject in all respects to the provisions contained in the pre-funded warrants.
Form and Term
The pre-funded warrants will be issued as individual warrant agreements to each individual purchaser of a pre-funded warrant. The form
of pre-funded warrant will be filed as an exhibit to a Current Report on Form 8-K that we will file with the SEC.
The pre-funded warrants do not expire.
Exercisability
The pre-funded warrants are exercisable at any
time after their original issuance. 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 and by payment in full of the exercise price in immediately available funds for the number
of shares of our common stock purchased upon such exercise. As an alternative to payment of the exercise price in immediately available
funds, the holder may elect to exercise the pre-funded warrant through a cashless exercise, in which case the holder would receive upon
such exercise the net number of shares of our common stock determined according to the formula set forth in the pre-funded warrant. No
fractional shares of our common stock will be issued in connection with the exercise of a pre-funded warrant. In lieu of fractional shares,
we will pay the holder an amount in cash equal to the fractional amount multiplied by the last closing trading price of our common stock
on the exercise date.
Exercise limitations
Under the pre-funded warrants, we may not effect
the exercise of any portion of any pre-funded warrant, and a holder will not have the right to exercise any portion of any pre-funded
warrant, which, upon giving effect to such exercise, would cause the aggregate number of shares of our common stock beneficially owned
by the holder (together with its affiliates) to exceed 4.99% of the number of shares of our common stock outstanding immediately after
giving effect to the exercise. However, any holder may increase or decrease such percentage to any other percentage not in excess of 4.99%
upon at least 61 days’ prior notice from the holder to us.
Exercise price
The exercise price per whole share of our common
stock purchasable upon the exercise of the pre-funded warrants is $0.0001 per share of our common stock. The exercise price of the pre-funded
warrants and the number of shares of our common stock issuable upon exercise of the pre-funded warrants are subject to appropriate adjustment
in the event of certain stock dividends and distributions, stock splits, stock combinations, reclassifications or similar events affecting
our common stock and also upon any distributions of assets, including cash, stock or other property to our stockholders. The exercise
price will not be adjusted below the par value of our common stock.
Charges, Taxes and Expenses
Issuance and delivery
of shares of our common stock upon exercise of a pre-funded warrant will be made without charge to the holder thereof for any
issue or transfer tax, transfer agent fee or other incidental tax or expense (excluding any applicable stamp duties) in respect of the
issuance thereof, all of which taxes and expenses shall be paid by us. However, we are not required to pay any tax that may be payable
in respect of any transfer involved in the registration of any warrant shares or pre-funded warrants in a name other than that
of the holder or an affiliate thereof. The holder shall be responsible for all other tax liability that may arise as a result of holding
or transferring its pre-funded warrants or receiving shares upon exercise thereof.
Transferability
Subject to applicable laws, the pre-funded warrants
may be offered for sale, sold, transferred or assigned without our consent. The pre-funded warrants will be held in definitive form by
the warrant agent. The ownership of the pre-funded warrants and any transfers of the pre-funded warrants will be registered in a warrant
register maintained by the warrant agent. We will initially act as warrant agent.
Exchange listing
We do not plan to apply to list the pre-funded
warrants on the Nasdaq Global Market, any other national securities exchange or any other nationally recognized trading system.
Fundamental transactions
In the event of a fundamental transaction, as
described in the pre-funded warrants and generally including any reorganization, recapitalization or reclassification of our common stock,
the sale, transfer or other disposition of all or substantially all of our properties or assets, our consolidation or merger with or into
another person, the acquisition of more than 50% of our outstanding common stock, or any person or group becoming the beneficial owner
of 50% of the voting power represented by our outstanding common stock, upon consummation of such a fundamental transaction, 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 without regard to any limitations on exercise contained in the pre-funded warrants.
No rights as a stockholder
Except by virtue of such holder’s ownership
of shares of our common stock, the holder of a pre-funded warrant does not have the rights or privileges of a holder of our common stock,
including any voting rights or the rights to receive dividends, until the holder exercises the pre-funded warrant. In the event of certain
distributions, including cash dividends, if any, to all holders of our common stock for no consideration, the holder of a pre-funded warrant
shall be entitled to participate in such distributions to the same extent as if such holder held the number of shares of our common stock
acquirable upon complete exercise of its pre-funded warrant (without regard to any limitations on exercise). If such distribution would
result in such holder and the other attribution parties exceeding the exercise limitations described above, a portion of such distribution
shall be held in abeyance for the benefit of such holder until such time as the ownership limitations would not be exceeded.
UNDERWRITING
We entered into an underwriting agreement with
the underwriters named below on , 2023. RBC
Capital Markets, LLC and Truist Securities, Inc. are acting as the representatives of the underwriters. Subject to the terms and conditions
stated in the underwriting agreement dated the date of this prospectus supplement, each underwriter named below has severally and not
jointly agreed to purchase, and we have agreed to sell to that underwriter, the number of shares of our common stock and pre-funded warrants
set forth opposite the underwriter’s name.
| Underwriter | |
Number of Shares | | |
Number of pre-funded warrants | |
| RBC Capital Markets, LLC | |
| | | |
| | |
| Truist Securities, Inc. | |
| | | |
| | |
| JMP Securities LLC | |
| | | |
| | |
| Total | |
| | | |
| | |
The underwriting agreement provides that the obligations
of the underwriters to purchase the shares of our common stock or pre-funded warrants included in this offering are subject to approval
of legal matters by counsel and to other conditions. The underwriters are obligated to purchase all the shares of our common stock or
pre-funded warrants (other than those covered by the underwriters’ option to purchase additional shares of our common stock option
described below) if they purchase any of the shares of our common stock or pre-funded warrants.
Shares of our common stock and pre-funded warrants
sold by the underwriters to the public will initially be offered at the initial public offering price set forth on the cover of this prospectus
supplement. Any shares of our common stock and pre-funded warrants sold by the underwriters to securities dealers may be sold at a discount
from the initial public offering price not to exceed $ per share. If all the shares of common stock or pre-funded warrants are not sold
at the initial offering price, the underwriters may change the offering price and the other selling terms.
Underwriting
discounts and commissions
The following table shows the underwriting discounts
and commissions that we are to pay to the underwriters in connection with this offering. These amounts are shown assuming both no exercise
and full exercise of the underwriters’ option to purchase additional shares.
| | |
Paid by the
Company | |
| | |
No Exercise | | |
Full Exercise | |
| Per share of common stock | |
$ | | | |
$ | | |
| Per pre-funded warrant | |
$ | | | |
$ | | |
| Total | |
$ | | | |
$ | | |
Indemnification
We have agreed to indemnify the underwriters against
certain liabilities, including liabilities under the Securities Act, or to contribute to payments the underwriters may be required to
make because of any of those liabilities.
Option to
Purchase Additional Shares
We have granted to the underwriters an option,
exercisable for 30 days from the date of this prospectus supplement, to purchase up to additional
shares at the public offering price less the underwriting discounts and commissions. To the extent the option is exercised, each underwriter
must purchase a number of additional shares approximately proportionate to that underwriter’s initial purchase commitment. Any shares
of our common stock issued or sold under the option will be issued and sold on the same terms and conditions as the other shares that
are the subject of this offering.
Lock-Ups
We and our officers and directors have agreed
that, for a period of 90 days from the date of this prospectus supplement, we and they will not, without the prior written consent of
the Representatives, dispose of or hedge any shares or any securities convertible into or exchangeable for our common stock, subject to
certain customary exceptions, the Representatives in their sole discretion, may release any of the securities subject to these lock-up
agreements at any time without notice.
NASDAQ Global
Market Listing
The shares are listed on the Nasdaq Global Market
under the symbol “CRMD.” We do not intend to list the pre-funded warrants on the Nasdaq Global Market, any other national
securities exchange or any other nationally recognized trading system.
Expenses and
Reimbursements
We estimate that our portion of the total expenses
of this offering will be $ , which includes the fees and expenses for which we have agreed to reimburse the underwriters.
Price Stabilization,
Short Positions and Penalty Bids
In connection with the offering, the underwriters
may purchase and sell shares of our common stock and pre-funded warrants in the open market. Purchases and sales in the open market may
include short sales, purchases to cover short positions, which may include purchases pursuant to the underwriters’ option to purchase
additional shares of our common stock, and stabilizing purchases.
| ● | Short sales involve secondary market sales by the underwriters
of a greater number of shares than they are required to purchase in the offering. |
| ● | “Covered” short sales are sales of shares in
an amount up to the number of shares represented by the underwriters’ option to purchase additional shares. |
| ● | “Naked” short sales are sales of shares in an
amount in excess of the number of shares represented by the underwriters’ option to purchase additional shares. |
| ● | Covering transactions involve purchases of shares either
pursuant to the underwriters’ option to purchase additional shares or in the open market in order to cover short positions. |
| ● | To close a naked short position, the underwriters must purchase
shares in the open market. A naked short position is more likely to be created if the underwriters are concerned that there may be downward
pressure on the price of the shares in the open market after pricing that could adversely affect investors who purchase in the offering. |
| ● | To close a covered short position, the underwriters must
purchase shares in the open market or must exercise the underwriters’ option to purchase additional shares. In determining the source
of shares to close the covered short position, the underwriters will consider, among other things, the price of shares available for
purchase in the open market as compared to the price at which they may purchase shares through the underwriters’ option to purchase additional
shares. |
| ● | Stabilizing transactions involve bids to purchase shares
so long as the stabilizing bids do not exceed a specified maximum. |
Purchases to cover short positions and stabilizing
purchases, as well as other purchases by the underwriters for their own accounts, may have the effect of preventing or retarding a decline
in the market price of the shares. They may also cause the price of the shares to be higher than the price that would otherwise exist
in the open market in the absence of these transactions. The underwriters may conduct these transactions on the Nasdaq Global Market,
in the over-the-counter market or otherwise. If the underwriters commence any of these transactions, they may discontinue them at any
time.
In addition, in connection with this offering,
some of the underwriters (and selling group members, if any) may engage in passive market making transactions in the shares on the Nasdaq
Global Market, prior to the pricing and completion of the offering. Passive market making consists of displaying bids on the Nasdaq Global
Market no higher than the bid prices of independent market makers and making purchases at prices no higher than those independent bids
and effected in response to order flow. Net purchases by a passive market maker on each day are limited to a specified percentage of the
passive market maker’s average daily trading volume in the shares during a specified period and must be discontinued when that limit
is reached. Passive market making may cause the price of the shares to be higher than the price that otherwise would exist in the open
market in the absence of those transactions. If the underwriters commence passive market making transactions, they may discontinue them
at any time.
Electronic
Distribution
In connection with the offering, certain of the
underwriters or securities dealers may distribute prospectuses by electronic means, such as e-mail.
Other Relationships
The underwriters are full service financial institutions
engaged in various activities, which may include securities trading, commercial and investment banking, financial advisory, investment
management, principal investment, hedging, financing and brokerage activities. The underwriters and their respective affiliates have in
the past performed commercial banking, investment banking and advisory services for us from time to time for which they have received
customary fees and reimbursement of expenses and may, from time to time, engage in transactions with and perform services for us in the
ordinary course of their business for which they may receive customary fees and reimbursement of expenses. In the ordinary course of their
various business activities, the underwriters and their respective affiliates may make or hold a broad array of investments and actively
trade debt and equity securities (or related derivative securities) and financial instruments (which may include bank loans and/or credit
default swaps) for their own account and for the accounts of their customers and may at any time hold long and short positions in such
securities and instruments. Such investments and securities activities may involve securities and/or instruments of ours or our affiliates.
The underwriters and their affiliates may also make investment recommendations and/or publish or express independent research views in
respect of such securities or financial instruments and may hold, or recommend to clients that they acquire, long and/or short positions
in such securities and instruments. For example, Truist Securities, Inc. and JMP Securities LLC, act as the sales agents under our At-the-Market
Issuance Sales Agreement, pursuant to which we may sell, from time to time, an aggregate of up to $50 million of our common stock.
Sales Outside
the United States
No action has been taken in any jurisdiction (except
in the United States) that would permit a public offering of our common stock or pre-funded warrants, or the possession, circulation or
distribution of this prospectus supplement or any other material relating to us or our common stock or pre-funded warrants in any jurisdiction
where action for that purpose is required. Accordingly, the shares of common stock or pre-funded warrants may not be offered or sold,
directly or indirectly, and neither this prospectus supplement nor any other offering material or advertisements in connection with our
common stock or pre-funded warrants may be distributed or published, in or from any country or jurisdiction, except in compliance with
any applicable rules and regulations of any such country or jurisdiction.
The underwriters may arrange to sell the common
stock or pre-funded warrants offered hereby in certain jurisdictions outside the United States, either directly or through affiliates,
where it is permitted to do so.
European Economic
Area
In relation to each Member State of the European
Economic Area which has implemented the Prospectus Directive (each, a “Relevant Member State”) an offer to the public of shares
of our common stock or pre-funded warrants may not be made in that Relevant Member State, except that an offer to the public in that Relevant
Member State of shares of our common stock or pre-funded warrants may be made at any time under the following exemptions under the Prospectus
Directive:
| (a) | to any legal entity which is a qualified investor as defined
in the Prospectus Directive; |
| (b) | to fewer than 150 natural or legal persons (other than qualified
investors as defined in the Prospectus Directive), subject to obtaining the prior consent of the representative for any such offer; or |
| (c) | in any other circumstances falling within Article 3(2) of
the Prospectus Directive, provided that no such offer of shares of our common stock shall result in a requirement for the publication
by us or any underwriter of a prospectus pursuant to Article 3 of the Prospectus Directive. |
For the purposes of this provision, the expression
an “offer to the public” in relation to shares of our common stock or pre-funded warrants in any Relevant Member State means
the communication in any form and by any means of sufficient information on the terms of the offer and any shares of our common stock
or pre-funded warrants to be offered so as to enable an investor to decide to purchase any shares of our common stock or pre-funded warrants,
as the same may be varied in that Member State by any measure implementing the Prospectus Directive in that Member State, the expression
“Prospectus Directive” means Directive 2003/71/EC (as amended), including by Directive 2010/73/EU, and includes any relevant
implementing measure in the Relevant Member State.
This European Economic Area selling restriction
is in addition to any other selling restrictions set out below.
United Kingdom
In the United Kingdom, this prospectus supplement
is only addressed to and directed as qualified investors who are (i) investment professionals falling within Article 19(5) of the Financial
Services and Markets Act 2000 (Financial Promotion) Order 2005 (the Order); or (ii) high net worth entities and other persons to whom
it may lawfully be communicated, falling within Article 49(2)(a) to (d) of the Order (all such persons together being referred to as “relevant
persons”). Any investment or investment activity to which this prospectus supplement relates is available only to relevant persons
and will only be engaged with relevant persons. Any person who is not a relevant person should not act or relay on this prospectus supplement
or any of its contents.
Hong Kong
The shares of our common stock or pre-funded warrants
may not be offered or sold in Hong Kong by means of any document other than (i) in circumstances which do not constitute an offer to the
public within the meaning of the Companies (Winding Up and Miscellaneous Provisions) Ordinance (Cap. 32 of the Laws of Hong Kong) (“Companies
(Winding Up and Miscellaneous Provisions) Ordinance”) or which do not constitute an invitation to the public within the meaning
of the Securities and Futures Ordinance (Cap. 571 of the Laws of Hong Kong) (“Securities and Futures Ordinance”), or (ii)
to “professional investors” as defined in the Securities and Futures Ordinance and any rules made thereunder, or (iii) in
other circumstances which do not result in the document being a “prospectus” as defined in the Companies (Winding Up and Miscellaneous
Provisions) Ordinance, and no advertisement, invitation or document relating to the shares of our common stock or pre-funded warrants
may be issued or may be in the possession of any person for the purpose of issue (in each case whether in Hong Kong or elsewhere), which
is directed at, or the contents of which are likely to be accessed or read by, the public in Hong Kong (except if permitted to do so under
the securities laws of Hong Kong) other than with respect to shares or pre-funded warrants which are or are intended to be disposed of
only to persons outside Hong Kong or only to “professional investors” in Hong Kong as defined in the Securities and Futures
Ordinance and any rules made thereunder.
Singapore
This prospectus supplement has not been registered
as a prospectus with the Monetary Authority of Singapore. Accordingly, this prospectus supplement and any other document or material in
connection with the offer or sale, or invitation for subscription or purchase, of the shares of our common stock or pre-funded warrants
may not be circulated or distributed, nor may the shares be offered or sold, or be made the subject of an invitation for subscription
or purchase, whether directly or indirectly, to persons in Singapore other than (i) to an institutional investor (as defined under Section
4A of the Securities and Futures Act, Chapter 289 of Singapore (the “SFA”)) under Section 274 of the SFA, (ii) to a relevant
person (as defined in Section 275(2) of the SFA) pursuant to Section 275(1) of the SFA, or any person pursuant to Section 275(1A) of the
SFA, and in accordance with the conditions specified in Section 275 of the SFA or (iii) otherwise pursuant to, and in accordance with
the conditions of, any other applicable provision of the SFA, in each case subject to conditions set forth in the SFA.
Where the shares of our common stock or pre-funded
warrants are subscribed or purchased under Section 275 of the SFA by a relevant person which is a corporation (which is not an accredited
investor (as defined in Section 4A of the SFA)) the sole business of which is to hold investments and the entire share capital of which
is owned by one or more individuals, each of whom is an accredited investor, the securities (as defined in Section 239(1) of the SFA)
of that corporation shall not be transferable for 6 months after that corporation has acquired the shares under Section 275 of the SFA
except: (1) to an institutional investor under Section 274 of the SFA or to a relevant person (as defined in Section 275(2) of the SFA),
(2) where such transfer arises from an offer in that corporation’s securities pursuant to Section 275(1A) of the SFA, (3) where
no consideration is or will be given for the transfer, (4) where the transfer is by operation of law, (5) as specified in Section 276(7)
of the SFA, or (6) as specified in Regulation 32 of the Securities and Futures (Offers of Investments) (Shares and Debentures) Regulations
2005 of Singapore (“Regulation 32”).
Where the shares of our common stock or pre-funded
warrants are subscribed or purchased under Section 275 of the SFA by a relevant person which is a trust (where the trustee is not an accredited
investor (as defined in Section 4A of the SFA)) whose sole purpose is to hold investments and each beneficiary of the trust is an accredited
investor, the beneficiaries’ rights and interest (howsoever described) in that trust shall not be transferable for 6 months after
that trust has acquired the shares of our common stock or pre-funded warrants under Section 275 of the SFA except: (1) to an institutional
investor under Section 274 of the SFA or to a relevant person (as defined in Section 275(2) of the SFA), (2) where such transfer arises
from an offer that is made on terms that such rights or interest are acquired at a consideration of not less than S$200,000 (or its equivalent
in a foreign currency) for each transaction (whether such amount is to be paid for in cash or by exchange of securities or other assets),
(3) where no consideration is or will be given for the transfer, (4) where the transfer is by operation of law, (5) as specified in Section
276(7) of the SFA, or (6) as specified in Regulation 32.
Japan
The securities have not been and will not be registered
under the Financial Instruments and Exchange Act of Japan (Act No. 25 of 1948, as amended), or the FIEA. The securities may not be offered
or sold, directly or indirectly, in Japan or to or for the benefit of any resident of Japan (including any person resident in Japan or
any corporation or other entity organized under the laws of Japan) or to others for reoffering or resale, directly or indirectly, in Japan
or to or for the benefit of any resident of Japan, except pursuant to an exemption from the registration requirements of the FIEA and
otherwise in compliance with any relevant laws and regulations of Japan.
Canada
The securities may be sold in Canada only to purchasers
purchasing, or deemed to be purchasing, as principal that are accredited investors, as defined in National Instrument 45-106 Prospectus
Exemptions or subsection 73.3(1) of the Securities Act (Ontario), and are permitted clients, as defined in National Instrument 31-103
Registration Requirements, Exemptions, and Ongoing Registrant Obligations. Any resale of the securities must be made in accordance with
an exemption form, or in a transaction not subject to, the prospectus requirements of applicable securities laws.
Securities legislation in certain provinces or
territories of Canada may provide a purchaser with remedies for rescission or damages if this offering memorandum (including any amendment
thereto) contains a misrepresentation, provided that the remedies for rescission or damages are exercised by the purchaser within the
time limit prescribed by the securities legislation of the purchaser’s province or territory. The purchaser should refer to any applicable
provisions of the securities legislation of the purchaser’s province or territory of these rights or consult with a legal advisor.
Pursuant to section 3A.3 of National Instrument
33-105 Underwriting Conflicts (NI 33-105), the underwriters are not required to comply with the disclosure requirements of NI 33-105 regarding
underwriter conflicts of interest in connection with this offering.
Australia
No placement document, prospectus, product disclosure
statement or other disclosure document has been lodged with the Australian Securities and Investments Commission (“ASIC”),
in relation to the offering. This prospectus supplement does not constitute a prospectus, product disclosure statement or other disclosure
document under the Corporations Act 2001 (the “Corporations Act”), and does not purport to include the information required
for a prospectus, product disclosure statement or other disclosure document under the Corporations Act.
Any offer in Australia of the shares may only
be made to persons (the “Exempt Investors”) who are “sophisticated investors” (within the meaning of section 708(8)
of the Corporations Act), “professional investors” (within the meaning of section 708(11) of the Corporations Act) or otherwise
pursuant to one or more exemptions contained in section 708 of the Corporations Act so that it is lawful to offer the shares without disclosure
to investors under Chapter 6D of the Corporations Act.
The shares of our common stock or pre-funded warrants
applied for by Exempt Investors in Australia must not be offered for sale in Australia in the period of 12 months after the date of allotment
under the offering, except in circumstances where disclosure to investors under Chapter 6D of the Corporations Act would not be required
pursuant to an exemption under section 708 of the Corporations Act or otherwise or where the offer is pursuant to a disclosure document
which complies with Chapter 6D of the Corporations Act. Any person acquiring shares must observe such Australian on-sale restrictions.
This prospectus supplement contains general information
only and does not take account of the investment objectives, financial situation or particular needs of any particular person. It does
not contain any securities recommendations or financial product advice. Before making an investment decision, investors need to consider
whether the information in this prospectus supplement is appropriate to their needs, objectives and circumstances, and, if necessary,
seek expert advice on those matters.
Switzerland
The shares of our common stock or pre-funded warrants
may not be publicly offered in Switzerland and will not be listed on the SIX Swiss Exchange (“SIX”) or on any other stock
exchange or regulated trading facility in Switzerland. This document has been prepared without regard to the disclosure standards for
issuance prospectuses under art. 652a or art. 1156 of the Swiss Code of Obligations or the disclosure standards for listing prospectuses
under art. 27 ff. of the SIX Listing Rules or the listing rules of any other stock exchange or regulated trading facility in Switzerland.
Neither this document nor any other offering or marketing material relating to the shares of our common stock or pre-funded warrants or
the offering may be publicly distributed or otherwise made publicly available in Switzerland.
Neither this document nor any other offering or
marketing material relating to the offering, the Company, the shares of our common stock or pre-funded warrants have been or will be filed
with or approved by any Swiss regulatory authority. In particular, this document will not be filed with, and the offer of shares of our
common stock or pre-funded warrants will not be supervised by, the Swiss Financial Market Supervisory Authority FINMA (FINMA), and the
offer of shares has not been and will not be authorized under the Swiss Federal Act on Collective Investment Schemes (“CISA”).
The investor protection afforded to acquirers of interests in collective investment schemes under the CISA does not extend to acquirers
of shares of our common stock or pre-funded warrants.
Israel
This document does not constitute a prospectus
under the Israeli Securities Law, 5728-1968, or the Securities Law, and has not been filed with or approved by the Israel Securities Authority.
State of Israel, this document is being distributed only to, and is directed only at, and any offer of securities is directed only at,
investors listed in the first addendum to the Israeli Securities Law (the “Addendum”), consisting primarily of joint investment
in trust funds, provident funds, insurance companies, banks, portfolio managers, investment advisors, members of the Tel Aviv Stock Exchange,
underwriters, venture capital funds, entities with equity in excess of NIS 50 million and “qualified individuals”, each as
defined in the Addendum (as it may be amended from time to time), collectively referred to as qualified investors (in each case purchasing
for their own account or, where permitted under the Addendum, for the accounts of their clients who are investors listed in the Addendum).
Qualified investors will be required to submit written confirmation that they fall within the scope of the Addendum, are aware of the
meaning of same and agree to it.
MATERIAL U.S. FEDERAL INCOME
TAX CONSIDERATIONS FOR NON-U.S. HOLDERS
The following is a summary of the material U.S.
federal income tax considerations relevant to a non-U.S. holder (as defined below) in respect of the purchase, ownership and disposition
of our common stock and pre-funded warrants issued pursuant to this offering as of the date hereof. Except where noted, this summary deals
only with common stock that is held as a capital asset (generally, property held for investment) within the meaning of Section 1221 of
the Internal Revenue Code of 1986 as amended (the “Code”).
A “non-U.S. holder” means a person
(other than an entity or arrangement treated as a partnership for U.S. federal income tax purposes) that is not, for U.S. federal income
tax purposes, any of the following:
| ● | an individual citizen or resident
of the United States; |
| ● | a corporation created or organized
in or under the laws of the United States, any state thereof or the District of Columbia; |
| ● | an estate the income of which
is subject to U.S. federal income taxation regardless of its source; or |
| ● | a trust if it (1) is subject
to the primary supervision of a court within the United States and one or more United States persons 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 United States person. |
If a partnership (or other entity or arrangement
treated as a partnership for U.S. federal income tax purposes) holds our common stock or pre-funded warrants, the tax treatment of a partner
in such partnership will generally depend upon the status of the partner and the activities of the partnership. If you are a partner of
a partnership holding our common stock, you should consult your tax advisors.
This summary is based upon provisions of the Code,
U.S. Treasury regulations promulgated thereunder, administrative rulings and judicial decisions, all as of the date hereof. Those authorities
may be changed, perhaps retroactively, or may be subject to differing interpretation, so as to result in U.S. federal income tax consequences
different from those summarized below. We have not sought any ruling from the Internal Revenue Service (the “IRS”) with respect
to the statements made and the conclusions reached in the following summary, and there can be no assurance that the IRS or a court will
agree with such statements and conclusions.
This summary does not address all aspects of U.S.
federal income taxes that may be relevant to you, such as the Medicare contribution tax on net investment income or the alternative minimum
tax (including the alternative minimum tax on financial statement income applicable to corporations), and does not deal with U.S. federal
non-income tax, foreign, state, local or other tax considerations that may be relevant to you in light of your particular circumstances.
In addition, it does not represent a detailed description of the U.S. federal income tax considerations relevant to you if you are subject
to special treatment under the U.S. federal income tax laws (including if you are a bank, insurance company or other financial institution,
a tax-exempt organization, a controlled foreign corporation, passive foreign investment company or corporation that accumulates earnings
to avoid U.S. federal income tax, a dealer or broker in securities or currencies, a trader in securities that elects to use a mark-to-market
method of accounting, a real estate investment trust or regulated investment company, a taxpayer whose functional currency is not the
U.S. dollar, a former citizen or long-term resident of the U.S., an accrual method taxpayer subject to special tax accounting rules pursuant
to Section 451(b) of the Code, or if you hold our common stock as part of a straddle, hedge, conversion, constructive sale, or other integrated
transaction). We cannot assure you that a change in law will not alter significantly the U.S. federal income tax considerations that we
describe in this summary.
If you are considering the purchase of our common
stock or pre-funded warrants, you should consult your own tax advisors concerning the particular U.S. federal income tax considerations
that may be relevant to you of the purchase, ownership or disposition of our common stock, as well as the consequences to you arising
under the laws of any other taxing jurisdiction.
Characterization
of the Pre-funded Warrants
Although the characterization
of the pre-funded warrants for U.S. federal income tax purposes is not entirely clear, because the exercise price of the pre-funded warrants
is a nominal amount, we expect to treat the pre-funded warrants as our common stock for U.S. federal income tax purposes. Except
where noted, the remainder of this discussion assumes that the pre-funded warrants will be so treated. Each non-U.S. holder
should consult its own tax advisor regarding the proper characterization of the pre-funded warrants for U.S. federal income tax
purposes, and the consequences to them of such treatment given their individual circumstances. Some portions of the below discussion make
reference to potential consequences associated with the purchase, ownership and disposition of the pre-funded warrants independent
of their potential characterization as common stock.
Dividends
Distributions on our common stock will constitute
dividends for U.S. federal income tax purposes to the extent paid out of our current or accumulated earnings and profits, as determined
under U.S. federal income tax principles. Amounts not treated as dividends for U.S. federal income tax purposes will constitute a return
of capital and will first be applied against and reduce a non-U.S. holder’s adjusted tax basis in their common stock, but not below
zero. Any remaining excess will be treated as capital gain subject to the rules discussed under “—Gain on Disposition of Common
Stock.”
In addition, if we are classified as a “USRPHC”
(as defined below) and any distribution exceeds our current and accumulated earnings and profits, we will need to satisfy our withholding
requirements either by (a) treating the entire distribution (even if in excess of earnings and profits) as a dividend subject to the withholding
rules described below and withhold at a minimum rate of 15% or such lower rate as may be specified by an applicable income tax treaty
for distributions from a USRPHC; or (b) treating (i) only the amount of the distribution equal to our reasonable estimate of our current
and accumulated earnings and profits as a dividend subject to the withholding rules in the following paragraph; and (ii) the excess portion
of the distribution as subject to withholding at a rate of 15% (or such lower rate as may be specified by an applicable income tax treaty),
as if such excess were the result of a sale of shares in a USRPHC, with a credit generally allowed against the non-U.S. holder’s
U.S. federal income tax liability for the tax withheld from such excess. We believe that we currently are not a USRPHC, and we do not
expect to become a USRPHC for the foreseeable future (see discussion of USRPHCs below under “— Gain on Disposition of Common
Stock”).
Distributions characterized as dividends for U.S.
federal income tax purposes that are paid to a non-U.S. holder of our common stock generally will be subject to withholding of U.S. federal
income tax at a 30% rate or such lower rate as may be specified by an applicable income tax treaty. However, dividends that are effectively
connected with the conduct of a trade or business by the non-U.S. holder within the United States (and, if required by an applicable income
tax treaty, are attributable to a permanent establishment or other fixed base of the non-U.S. holder within the United States) are not
subject to withholding, provided certain certification and disclosure requirements are satisfied. Instead, such dividends are subject
to U.S. federal income tax on a net income basis in the same manner as if the non-U.S. holder were a United States person as defined under
the Code. Any such effectively connected dividends received by a foreign corporation may be subject to an additional “branch profits
tax” at a 30% rate or such lower rate as may be specified by an applicable income tax treaty.
A non-U.S. holder of our common stock who wishes
to claim the benefit of an applicable income tax treaty rate and avoid backup withholding, as discussed below, for dividends will be required
(a) to complete the applicable IRS Form W-8 or W-8BEN-E (or applicable successor form) and certify under penalty of perjury that such
holder is not a United States person as defined under the Code and is eligible for treaty benefits or (b) if our common stock is held
through certain foreign intermediaries, to satisfy the relevant certification requirements of applicable U.S. Treasury regulations.
A non-U.S. holder of our common stock eligible
for a reduced rate of U.S. withholding tax pursuant to an income tax treaty may obtain a refund of any excess amounts withheld by timely
filing an appropriate claim for refund with the IRS.
Gain on Disposition of Common Stock
Subject to the discussion of backup withholding
and FATCA below, any gain realized on the sale, exchange, redemption or other disposition of our common stock generally will not be subject
to U.S. federal income tax unless:
| ● | the gain is effectively connected
with a trade or business of the non-U.S. holder in the United States (and, if required by an applicable income tax treaty, is attributable
to a permanent establishment or other fixed base of the non-U.S. holder within the United States); |
| ● | the non-U.S. holder is an individual
who is present in the United States for 183 days or more in the taxable year of that disposition, and certain other conditions are met;
or |
| ● | we are or have been a USRPHC
for U.S. federal income tax purposes at any time within the shorter of the five-year period preceding the non-U.S. holder’s disposition
of, or the non-U.S. Holder’s holding period for, our common stock, and, in the case where shares of our common stock are regularly
traded on an established securities market, the non-U.S. holder owns, or is treated as owning, more than 5% of our common stock at any
time during the foregoing period. |
A non-U.S. holder described in the first bullet
point immediately above will be subject to tax on the net gain derived from the sale, exchange, redemption or other disposition of our
common stock under regular graduated U.S. federal income tax rates applicable to such holder as if it were a United States person as defined
under the Code. In addition, if a non-U.S. holder described in the first bullet point immediately above is treated as a corporation for
U.S. federal income tax purposes, it may be subject to an additional branch profits tax on its effectively connected earnings and profits
at a rate equal to 30% or such lower rate as may be specified by an applicable income tax treaty.
An individual non-U.S. holder described in the
second bullet point immediately above will be subject to a flat 30% tax on the gain derived from the sale, exchange, redemption or other
distribution, which may be offset by U.S.-source capital losses, even though the individual is not considered a resident of the United
States, provided such non-U.S. holder has timely filed U.S. federal income tax returns with respect to such losses.
Generally, a corporation is a USRPHC if the fair
market value of its United States real property interests equals or exceeds 50% of the aggregate fair market value of the corporation’s
worldwide real property interests and its other assets used or held for use in a trade or business. We believe we have not been, are not
and do not anticipate becoming a “United States real property holding corporation” for U.S. federal income tax purposes. However,
no assurances can be offered in this regard. Even if we become a USRPHC, however, as long as our common stock is treated as being regularly
traded on an established securities market, such common stock will be treated as U.S. real property interests only if a non-U.S. holder
actually or constructively holds more than 5% of such regularly traded common stock at any time during the shorter of the five-year period
preceding the non-U.S. holder’s disposition of, or the non-U.S. holder’s holding period for, our common stock. No assurance
can be provided that our common stock will be treated as being regularly traded on an established securities market at all times for purposes
of the rules described above.
If a non-U.S. holder is subject to U.S. federal
income tax on any disposition of our common stock, a redemption of shares of our common stock will be a taxable event. If the redemption
is treated as a sale or exchange, instead of as a dividend, a non-U.S. holder generally will recognize capital gain or loss, equal to
the difference between the amount of cash received and fair market value of any property received and the non-U.S. holder’s adjusted
tax basis in our common stock redeemed (except that to the extent that any cash received is attributable to any accrued but unpaid dividends),
and such capital gain or loss will be long-term capital gain or loss if the non-U.S. holder’s holding period for such common stock
exceeds one year. A payment made in redemption of our common stock may be treated in certain circumstances as a dividend (subject to taxation
as discussed above under “—Dividends”), rather than as payment in exchange for our common stock. Each non-U.S. holder
of our common stock or pre-funded warrants should consult its own independent tax advisors to determine whether a payment made in redemption
of our common stock will be treated as a dividend or as payment in exchange for our common stock.
Non-U.S. holders should consult their tax advisors
regarding potentially applicable income tax treaties that may provide for rules different than those discussed above.
Exercise of a Pre-Funded Warrant
A non-U.S. holder generally will not recognize
taxable gain or loss on the acquisition of common stock upon exercise of a pre-funded warrant. The non-U.S. holder’s aggregate tax
basis in the share of our common stock received upon exercise of a pre-funded warrant generally will be an amount equal to the sum of
the non-U.S. holder’s tax basis in the pre-funded warrant prior to exercise and the warrant’s exercise price (if any). Assuming
that a pre-funded warrant is treated as our common stock, the non-U.S. holder’s holding period for the common stock received upon
exercise of a pre-funded warrant will include the period during which the non-U.S. holder held the pre-funded warrant.
Certain Adjustments to the Pre-Funded Warrants
and Payments in Respect of Pre-funded Warrants
Under Section 305 of the Code, an adjustment to
the number of shares of common stock that will be issued on the exercise of a pre-funded warrant, or an adjustment to the exercise price
of a pre-funded warrant, may be treated as a constructive distribution to a non-U.S. holder of the pre-funded warrant if, and to the extent
that, such adjustment has the effect of increasing such non-U.S. holder’s proportionate interest in our “earnings and profits”
or assets, depending on the circumstances of such adjustment (for example, if such adjustment is to compensate for a distribution of cash
or other property to our shareholders). Adjustments to the exercise price of a pre-funded warrant made pursuant to a bona fide reasonable
adjustment formula that has the effect of preventing dilution of the interest of the non-U.S. holder of the pre-funded warrant generally
should not be considered to result in a constructive distribution. Such constructive distribution would be treated as a dividend, return
of capital or capital gain as described under the heading “—Dividends” above. Any such constructive distribution would
be taxable whether or not there is an actual distribution of cash or other property.
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 the pre-funded warrants that references a dividend distribution on our common stock (including an adjustment to the amount
due on the pre-funded warrant to take into account a dividend distribution on our common stock) would be taxable to a non-U.S. holder
as described under the heading “—Dividends” above. Such dividend equivalent amount would be taxable and subject to withholding
whether or not there is actual payment of cash or other property, and we may satisfy any withholding obligations 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.
Information Reporting and Backup Withholding
We must report annually to the IRS and to each
non-U.S. holder the amount of dividends paid to such holder and the tax withheld with respect to such dividends, regardless of whether
withholding was required with respect thereto. Copies of the information returns reporting such dividends and withholding may also be
made available to the tax authorities in the country in which the non-U.S. holder resides under the provisions of an applicable income
tax treaty.
A non-U.S. holder will be subject to backup withholding
on dividends paid to such holder unless such holder certifies under penalty of perjury that it is a non-U.S. holder (and the payor does
not have actual knowledge or reason to know that such holder is a United States person as defined under the Code), or such holder otherwise
establishes an exemption.
Information reporting and, depending on the circumstances,
backup withholding will apply to the proceeds of a sale of our common stock within the United States or conducted through certain U.S.-related
financial intermediaries, unless the beneficial owner certifies under penalty of perjury that it is a non-U.S. holder (and the payor does
not have actual knowledge or reason to know that the beneficial owner is a United States person as defined under the Code), or such owner
otherwise establishes an exemption.
Backup withholding is not an additional tax. Any
amounts withheld under the backup withholding rules may be allowed as a refund or a credit against a non-U.S. holder’s U.S. federal
income tax liability provided the required information is timely furnished to the IRS.
Additional Withholding Requirements
Under Sections 1471 through 1474 of the Code (such
Sections commonly referred to as “FATCA”), a 30% U.S. federal withholding tax will apply to any dividends paid on our common
stock to (i) a “foreign financial institution” (as specifically defined in the Code) that does not provide sufficient documentation,
typically on IRS Form W-8BEN-E, evidencing either (x) an exemption from FATCA or (y) its compliance (or deemed compliance) with FATCA
(which may alternatively be in the form of compliance with an intergovernmental agreement with the United States) in a manner that avoids
withholding, or (ii) a “non-financial foreign entity” (as specifically defined in the Code) that does not provide sufficient
documentation, typically on IRS Form W-8BEN-E, evidencing either (x) an exemption from FATCA or (y) adequate information regarding certain
substantial U.S. beneficial owners of such entity (if any). If a dividend payment is both subject to withholding under FATCA and subject
to the withholding tax discussed above under “—Dividends,” the withholding under FATCA may be credited against, and
therefore reduce, such other withholding tax.
Withholding under FATCA may also apply to payments
to a foreign entity of gross proceeds from the sale, exchange or disposition of property that can produce United States-source interest
or dividends, such as our common stock. However, 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.
We will not pay any additional amounts to holders
of our common stock in respect of any amounts withheld. Non-U.S. holders should consult their own tax advisers with respect to the U.S.
federal income tax consequences of FATCA on their ownership and disposition of shares of our common stock. Documentation that holders
provide in order to be treated as FATCA compliant may be reported to the IRS and other tax authorities, including information about a
holder’s identity, its FATCA status and if applicable, its direct and indirect U.S. owners. Prospective investors should consult
their tax advisers about how information reporting and the possible imposition of withholding tax under FATCA may apply to their investment
in our common stock.
LEGAL MATTERS
The validity of the common stock and pre-funded
warrants offered by this prospectus supplement will be passed upon for us by Morgan, Lewis & Bockius LLP, New York, New York. The
underwriters are being represented by Goodwin Procter LLP, New York, New York.
EXPERTS
The consolidated financial statements as of and
for the year ended December 31, 2022 incorporated by reference in this registration statement have been audited by Marcum LLP, an
independent registered public accounting firm, as stated in their report, which is incorporated herein by reference. Such financial statements
are incorporated by reference in reliance upon the report of such firm given upon their authority as experts in accounting and auditing.
The consolidated financial statements as of and
for the year ended December 31, 2021 incorporated by reference in this registration statement have been audited by Friedman LLP,
an independent registered public accounting firm, as stated in their report, which is incorporated herein by reference. Such financial
statements are incorporated by reference in reliance upon the report of such firm given upon their authority as experts in accounting
and auditing.
WHERE YOU CAN FIND MORE
INFORMATION
We filed with the SEC a registration statement
on Form S-3 under the Securities Act with respect to the shares of common stock and pre-funded warrants offered hereby. This prospectus
supplement and the accompanying 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 filed with the registration statement. For further information about us and the
common stock offered hereby, we refer you to the registration statement and the exhibits filed with the registration statement. Statements
contained in this prospectus supplement and the accompanying prospectus regarding the contents of any contract or any other document that
is filed as an exhibit to the registration statement are not necessarily complete, and each such statement is qualified in all respects
by reference to the full text of such contract or other document filed as an exhibit to the registration statement.
We are subject to the information and reporting
requirements of the Exchange Act and, in accordance with this law, are required to file periodic reports, proxy statements and other information
with the SEC. 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 http://www.sec.gov.
INCORPORATION OF DOCUMENTS
BY REFERENCE
The SEC allows us to “incorporate by reference”
information that we file with them. Incorporation by reference allows us to disclose important information to you by referring you to
those other documents. The information incorporated by reference is an important part of this prospectus supplement and the accompanying
prospectus, and information that we file later with the SEC will automatically update and supersede this information. We filed a registration
statement on Form S-3 under the Securities Act with the SEC with respect to the securities being offered pursuant to this prospectus supplement
and the accompanying prospectus. This prospectus supplement and the accompanying prospectus omit certain information contained in the
registration statement, as permitted by the SEC. You should refer to the registration statement, including the exhibits, for further information
about us and the securities being offered pursuant to this prospectus supplement and the accompanying prospectus. Statements in this prospectus
supplement and the accompanying prospectus regarding the provisions of certain documents filed with, or incorporated by reference in,
the registration statement are not necessarily complete and each statement is qualified in all respects by that reference. The documents
we are incorporating by reference are (other than those documents or the portions of those documents not deemed to be filed):
| ● | our Annual Report on Form 10-K for the year ended December 31, 2022, filed with the SEC on March 30, 2023; |
| ● | our Quarterly Report on Form 10-Q for the quarter ended March 31, 2023, filed with the SEC on May 15,
2023; |
| ● | our
Current Reports on Form 8-K filed with the SEC on March 3, 2023, March 30, 2023, April 17, 2023, April 26, 2023, May 15, 2023, May 16, 2023 and June 21, 2023, provided
that any portions of such reports that are deemed furnished and not filed pursuant to instructions
to Form 8-K shall not be incorporated by reference into this prospectus supplement; and |
| ● | the description of common stock set forth in Exhibit 4.5 to our Annual Report on Form 10-K for the year
ended December 31, 2020, including any amendment or report filed for the purpose of updating such description. |
All documents subsequently filed with the SEC
under Sections 13(a), 13(c), 14 or 15(d) of the Exchange Act prior to the termination of this offering shall be deemed to be incorporated
by reference into this prospectus supplement. Any statement contained in any document incorporated by reference herein will be deemed
to be modified or superseded for purposes of this prospectus supplement to the extent that a statement contained in this prospectus supplement
or any additional prospectus supplement modifies or supersedes such statement. Any statement so modified or superseded will not be deemed,
except as so modified or superseded, to constitute a part of this prospectus supplement.
You may request a copy of these filings, at no
cost, by writing or telephoning us at the following address or phone number:
CorMedix Inc.
300 Connell Drive, Suite 4200
Berkeley Heights, NJ
Telephone: (908) 517-9500
Prospectus
$150,000,000 of
Common Stock,
Preferred Stock,
Warrants,
Debt Securities and/or
Units
From time to time, we may offer and sell up to
$150,000,000 in the aggregate of any combination of the securities described in this prospectus, either individually or in units, in one
or more offerings in amounts, at prices and on the terms that we will determine at the time of offering. We may also offer common stock
or preferred stock upon conversion of debt securities, common stock upon conversion of preferred stock, or common stock, preferred stock
or debt securities upon the exercise of warrants.
Each time we sell securities, we will provide specific
terms of the securities offered in a supplement to this prospectus. The prospectus supplement may also add, update or change information
contained in this prospectus. We will specify in any accompanying prospectus supplement the terms of any offering. You should read this
prospectus and the applicable prospectus supplement, as well as any documents incorporated by reference in this prospectus and any prospectus
supplement, carefully before you invest in any securities. This prospectus may not be used by us to consummate a sale of securities
unless accompanied by the applicable prospectus supplement describing the method and terms of such offering.
We will sell these securities directly to our stockholders
or to other purchasers or through agents on our behalf or through underwriters or dealers, or a combination of these methods, as designated
from time to time. If any agents or underwriters are involved in the sale of any of these securities, the applicable prospectus supplement
will provide the names of the agents or underwriters and any applicable fees, commissions or discounts.
Our common stock trades on the Nasdaq Global Market under the trading symbol
“CRMD.” On August 11, 2021, the closing price of our common stock was $5.91 per share. We recommend that you obtain
current market quotations for our common stock prior to making an investment decision.
You should carefully read this prospectus, the
applicable prospectus supplement relating to any specific offering of securities and all information incorporated by reference herein
and therein.
Investing in our securities involves a high
degree of risk. These risks are described under the caption “Risk Factors” beginning on page 5 of this prospectus and the
reports we file with the Securities and Exchange Commission pursuant to the Securities Exchange Act of 1934, as amended, and in an applicable
prospectus supplement and in other documents that are incorporated by reference into this prospectus and any applicable prospectus supplement
concerning factors you should consider before investing in our securities. Neither the Securities and Exchange Commission nor any state
securities commission has approved or disapproved of these securities or determined if this prospectus is truthful or complete. Any representation
to the contrary is a criminal offense.
The date of this prospectus is August 20, 2021
Table
of Contents
ABOUT THIS PROSPECTUS
This prospectus is part of a registration statement
on Form S-3 that we filed with the Securities and Exchange Commission, or SEC, using a “shelf” registration process. Under
this shelf registration process, we may offer and sell shares of our common stock and preferred stock, various series of debt securities
and/or warrants to purchase any of such securities, either individually or in units, in one or more offerings, of an indeterminate amount
for total gross proceeds of up to $150,000,000. This prospectus provides you with a general description of the securities we may offer.
Each time we offer a type or series of securities under this prospectus, we will provide a prospectus supplement that will contain specific
information about the terms of that offering. We may also authorize one or more free writing prospectuses to be provided to you that may
contain material information relating to a particular offering.
This prospectus does not contain all of the information
included in the registration statement. For a more complete understanding of the offering of the securities, you should refer to the registration
statement, including its exhibits. Prospectus supplements may also add, update or change information contained or incorporated by reference
in this prospectus or in the documents that we have incorporated by reference into this prospectus. However, no prospectus supplement
will fundamentally change the terms that are set forth in this prospectus or offer a security that is not registered and described in
this prospectus at the time of its effectiveness. This prospectus, together with the applicable prospectus supplements and the documents
incorporated by reference into this prospectus, includes all material information relating to this offering. You should carefully read
this prospectus, the applicable prospectus supplement, the information and documents incorporated herein by reference and the additional
information under the heading “Where You Can Find More Information” before making an investment decision.
We further note that the representations, warranties
and covenants made by us in any agreement that is filed as an exhibit to any document that is incorporated by reference into this prospectus
or any accompanying prospectus supplement were made solely for the benefit of the parties to such agreement, including, in some cases,
for the purpose of allocating risk among the parties to such agreement, and should not be deemed to be a representation, warranty or covenant
to you. Moreover, such representations, warranties or covenants were accurate only as of the date when made. Accordingly, such representations,
warranties and covenants should not be relied on as accurately representing the current state of our affairs.
It is important for you to read and consider all
of the information contained in this prospectus and any accompanying prospectus in making your investment decision. We include cross-references
in this prospectus and any accompanying prospectus to captions in these materials where you can find additional related discussions. The
table of contents in this prospectus provides the pages on which these captions are located.
You should rely only on the information we have
provided or incorporated by reference in this prospectus or any prospectus supplement. We have not authorized anyone to provide you with
information different from that contained or incorporated by reference in this prospectus. No dealer, salesperson or other person is authorized
to give any information or to represent anything not contained or incorporated by reference in this prospectus. You should not rely on
any unauthorized information or representation. This prospectus is an offer to sell only the securities offered hereby, but only under
circumstances and in jurisdictions where it is lawful to do so. You should not assume that the information contained in this prospectus,
the accompanying prospectus supplement or any free writing prospectus, or incorporated by reference herein, is accurate as of any date
other than as of the date of this prospectus or any prospectus supplement or any free writing prospectus, as the case may be, or in the
case of the documents incorporated by reference, the date of such documents regardless of the time of delivery of this prospectus and
any prospectus supplement or any sale of our securities. Our business, financial condition, liquidity, results of operations and prospects
may have changed since those dates.
To the extent there are inconsistencies between
any prospectus supplement, this prospectus and any documents incorporated by reference, the document with the most recent date will control.
This prospectus may not be used to consummate
sales of our securities, unless it is accompanied by a prospectus supplement.
This prospectus, any prospectus supplement, and
any free writing prospectus, and the information incorporated herein and therein by reference, include trademarks, service marks and trade
names owned by us or other companies. All trademarks, service marks and trade names included or incorporated by reference into this prospectus
supplement or the accompanying prospectus are the property of their respective owners.
Unless the context otherwise requires, “CorMedix,”
the “Company,” “we,” “us,” “our” and similar names refer to CorMedix Inc.
No action is being taken in any jurisdiction outside the United
States to permit a public offering of the securities or possession or distribution of this prospectus or any accompanying prospectus supplement
in that jurisdiction. Persons who come into possession of this prospectus or any accompanying prospectus supplement in jurisdictions outside
the United States are required to inform themselves about and to observe any restrictions as to this offering and the distribution of
this prospectus or any accompanying prospectus supplement applicable to that jurisdiction.
SPECIAL NOTE REGARDING FORWARD-LOOKING
STATEMENTS
The SEC encourages companies
to disclose forward-looking information so that investors can better understand a company’s future prospects and make informed investment
decisions. This prospectus supplement and the documents we have filed with the SEC that are incorporated herein by reference contain such
“forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995.
Words such as “may,”
“might,” “should,” “anticipate,” “estimate,” “expect,” “projects,”
“intends,” “plans,” “believes” and words and terms of similar substance used in connection with any
discussion of future operating or financial performance, identify forward-looking statements. Forward-looking statements represent management’s
current judgment regarding future events and are subject to a number of risks and uncertainties that could cause actual results to differ
materially from those described in the forward-looking statements. These risks include, but are not limited to: the results of CorMedix’s
discussions with the FDA regarding the DefenCath™ development path for marketing authorization; CorMedix’s ability to manage
its limited cash resources and the impact on current, planned or future research, including the continued development of DefenCath/Neutrolin®
and research for additional uses for taurolidine; CorMedix’s ability to obtain additional financing to support CorMedix’s
research and development and clinical activities and operations; that preclinical results are not indicative of success in clinical trials
and might not be replicated in any subsequent studies or trials; CorMedix’s ability to obtain approval of the New Drug Application
(NDA) for DefenCath, which is required to commercialize the product in the U.S.; CorMedix’s ability to secure reimbursement under
favorable terms for DefenCath when regulatory approval is obtained; obtaining regulatory approvals to conduct clinical trials and to commercialize
CorMedix’s product candidates; the outcome of clinical trials of CorMedix’s product candidates and whether they demonstrate
these candidates’ safety and effectiveness; the risks associated with the launch of DefenCath and Neutrolin in new markets; CorMedix’s
ability to enter into, execute upon and maintain collaborations with third parties for its development and marketing programs; CorMedix’s
dependence on its collaborations and its license relationships; CorMedix’s ability to conduct planned or future research, including
the continued development of DefenCath and Neutrolin and of additional uses for taurolidine; and the ability to retain and hire necessary
personnel to staff our operations appropriately; CorMedix’s ability to maintain its listing on the Nasdaq Global Market; achieving
milestones under CorMedix’s collaborations; CorMedix’s dependence on preclinical and clinical investigators, preclinical and
clinical research organizations, manufacturers, sales and marketing organizations, and consultants; and protecting the intellectual property
developed by or licensed to CorMedix. We continue to assess to what extent the uncertainty surrounding the Coronavirus pandemic may impact
our business and operations. Please also see the discussion of risks and uncertainties under “Risk Factors” below, and contained
in the accompanying prospectus and otherwise incorporated by reference herein, and in our most recent annual report on Form 10-K as well
as any amendments thereto, as revised or supplemented by our subsequent quarterly reports on Form 10-Q, as filed with the SEC and which
are incorporated herein by reference.
In light of these assumptions,
risks and uncertainties, the results and events discussed in the forward-looking statements contained in this prospectus supplement or
in any document incorporated herein by reference might not occur. Investors are cautioned not to place undue reliance on the forward-looking
statements, which speak only as of the date of this prospectus supplement or the date of the document incorporated by reference in this
prospectus supplement. We expressly disclaim any obligation to update or alter any forward-looking statements, whether as a result of
new information, future events or otherwise, except as required by federal securities laws.
PROSPECTUS
SUMMARY
This summary highlights certain information
about us, the securities offered hereby and selected information contained elsewhere in or incorporated by reference into this prospectus.
This summary is not complete and does not contain all of the information that you should consider before deciding whether to invest in
our securities. For a more complete understanding of our company and the securities offered hereby, we encourage you to read and consider
carefully the more detailed information in this prospectus, including the information incorporated by reference into this prospectus,
and the information referred to under the heading “Risk Factors” in this prospectus beginning on page 5, and in the documents
incorporated by reference into this prospectus.
OUR COMPANY
Overview
We are a biopharmaceutical
company focused on developing and commercializing therapeutic products for the prevention and treatment of infectious and inflammatory
diseases.
Our primary focus is on the
development of our lead product candidate, DefenCath™, for potential commercialization in the United States (“U.S.”)
and other key markets. We have in-licensed the worldwide rights to develop and commercialize DefenCath/Neutrolin®, which is a novel
anti-infective solution (a formulation of taurolidine 13.5 mg/ml and heparin 1000 USP Units/ml) intended for the reduction and prevention
of catheter-related infections and thrombosis in patients requiring central venous catheters (“CVCs”) in clinical settings
such as hemodialysis, total parenteral nutrition and oncology. Infection and thrombosis represent key complications among hemodialysis,
total parenteral nutrition and cancer patients with CVCs. These complications can lead to treatment delays and increased costs to the
healthcare system when they occur due to hospitalizations, need for intravenous (“IV”) antibiotic treatment, long-term anticoagulation
therapy, removal/replacement of the CVC, related treatment costs and increased mortality. The name DefenCath is the U.S. proprietary name
conditionally approved by the U.S. Food and Drug Administration (“FDA”), while the name Neutrolin is currently used in the
European Union (“EU”) and other territories where the Company has received CE-Mark approval for the commercial distribution
of Neutrolin as a catheter lock solution (“CLS”) regulated as a medical device. In January 2015, the FDA designated DefenCath
as a Qualified Infectious Disease Product (“QIDP”) for prevention of catheter-related blood stream infections (“CRBSIs)
in patients with end stage renal disease receiving hemodialysis through a central venous catheter. Catheter-related blood stream infections
and clotting can be life-threatening. The QIDP designation provides five years of market exclusivity in addition to the five years granted
for a New Chemical Entity (“NCE”) upon approval of a New Drug Application (“NDA”). In addition, in January 2015,
the FDA granted Fast Track designation to DefenCath Catheter Lock Solution, a designation intended to facilitate development and expedite
review of drugs that treat serious and life-threatening conditions so that the approved drug can reach the market expeditiously. The Fast
Track designation of DefenCath provides the Company with the opportunity to meet with the FDA on a more frequent basis during the development
process, and also ensures eligibility to request priority review of the marketing application. In December 2015, the Company launched
its Phase 3 Prospective, Multicenter, Double-blind, Randomized, Active Control Study to Demonstrate Safety & Effectiveness of DefenCath/Neutrolin
in Preventing Catheter-related Bloodstream Infection in Subjects on Hemodialysis for End Stage Renal Disease (“LOCK-IT-100”),
in patients with hemodialysis catheters in the U.S. The clinical trial was designed to demonstrate the safety and effectiveness of DefenCath
compared to the standard of care CLS, Heparin, in preventing CRBSIs. The primary endpoint for the trial assessed the incidence of CRBSI
and time to CRBSI for each study subject. Secondary endpoints were catheter patency, which was defined as required use of tissue plasminogen
activating factor, or tPA, or removal of catheter due to dysfunction, and removal of catheter for any reason.
The FDA granted the Company’s
request for a rolling submission and review of the NDA which is designed to expedite the approval process for products being developed
to address an unmet medical need. Although the FDA usually requires two pivotal clinical trials to provide substantial evidence of safety
and effectiveness for approval of an NDA, the FDA will in some cases accept one adequate and well-controlled trial, where it is a large
multicenter trial with a broad range of subjects and investigation sites with procedures to include trial quality that has demonstrated
a clinically meaningful and statistically very persuasive effect on prevention of a disease with potentially serious outcome. In March
2020, the Company began the modular submission process for the NDA for DefenCath for the prevention of CRBSI in hemodialysis patients,
and in August 2020, the FDA accepted for filing the DefenCath NDA. The FDA also granted the Company’s request for priority review,
which provides for a six-month review period instead of the standard ten-month review period. As the Company announced in March 2021,
the FDA informed in its Complete Response Letter (“CRL”) to the Company that it cannot approve the NDA for DefenCath in its
present form. The FDA noted concerns at the third-party manufacturing facility after a review of records requested by the FDA and provided
by the contract manufacturer (“CMO”). Additionally, the FDA is requiring a manual extraction study to demonstrate that the
labeled volume can be consistently withdrawn from the vials despite an existing in-process control to demonstrate fill volume within specifications.
In April 2021, the Company and
the CMO met with the FDA to discuss proposed resolutions for the deficiencies identified in the CRL to the Company and the Post-Application
Action Letter received by the CMO from the FDA for the NDA for DefenCath. There was an agreed upon protocol for the manual extraction
study identified in the CRL, which now has been successfully completed. Addressing the FDA’s concerns regarding the qualification
of the filling operation necessitated adjustments in the process and generation of additional data on operating parameters for manufacture
of DefenCath. The Company and the CMO determined that additional process qualification is needed with subsequent validation to address
these issues. The FDA stated that the review timeline would be determined when the NDA resubmission is received and that it expected
all corrections to facility deficiencies to be complete at the time of resubmission so that all corrective actions may be verified during
an onsite evaluation of the manufacturing facility in the next review cycle, if the FDA determines it will do an onsite evaluation. The
Company and the CMO continue to work closely to ensure that the identified deficiencies are resolved prior to resubmission of the DefenCath
NDA.
Satisfactory resolution of
these issues is required for approval of the DefenCath NDA. If an onsite inspection is required, the Company may encounter delays in obtaining
FDA approval because the FDA is currently facing a backlog due to the Covid-19 pandemic. The FDA issued a guidance document on its plan
to use voluntary remote interactive evaluations at facilities, including for a pre-approval inspection to assess a marketing application.
The FDA will request the manufacturing facility to participate in a voluntary remote interactive evaluation, if the FDA believes it is
appropriate. A manufacturing facility cannot request the remote interaction. The FDA expects the use of remote interactive evaluations
should help the FDA operate within normal timeframes in spite of the Covid-19 pandemic.
Although we cannot fully anticipate changes in
reimbursement requirements and mechanisms in the coming years, we expect DefenCath would be eligible for and would obtain TDAPA. DefenCath
meets the criterion of being a new renal dialysis product used to treat or manage a condition associated with ESRD, since infections are
the second leading cause of death in patients with ESRD and CVCs are a significant risk factor for infection-associated mortality.
International
In the European Union, or EU, Neutrolin is regulated
as a Class 3 medical device. In July 2013, we received CE Mark approval for Neutrolin. In December 2013, we commercially launched Neutrolin
in Germany for the prevention of CRBSI, and maintenance of catheter patency in hemodialysis patients using a tunneled, cuffed central
venous catheter for vascular access. To date, Neutrolin is registered and may be sold in certain European Union and Middle Eastern countries
for such treatment.
In September 2014, the TUV-SUD and The Medicines
Evaluation Board of the Netherlands, or MEB, granted a label expansion for Neutrolin for these same expanded indications for the EU. In
December 2014, we received approval from the Hessian District President in Germany to expand the label to include use in oncology patients
receiving chemotherapy, IV hydration and IV medications via central venous catheters. The expansion also adds patients receiving medication
and IV fluids via central venous catheters in intensive or critical care units (cardiac care unit, surgical care unit, neonatal critical
care unit, and urgent care centers). An indication for use in total parenteral nutrition was also approved.
Additional Development Possibilities
In addition to developing the use of taurolidine
as a catheter lock solution, we are sponsoring a pre-clinical research collaboration for the use of taurolidine as a possible treatment
for rare pediatric tumors. In February 2018, the FDA granted orphan drug designation to taurolidine for the treatment of neuroblastoma
in children. We may seek one or more strategic partners or other sources of capital to help us develop and commercialize taurolidine for
the treatment of neuroblastoma in children. We are also evaluating opportunities for the possible expansion of taurolidine as a platform
compound for use in certain medical devices. Patent applications have been filed in several indications, including wound closure, surgical
meshes, and wound management. Based on initial feasibility work, we are advancing pre-clinical studies for taurolidine-infused surgical
meshes, suture materials and hydrogels. We will seek to establish development/commercial partnerships as these programs advance.
The FDA regards taurolidine as a new chemical entity
and therefore it is currently regulated as an unapproved new drug. We might in the future pursue product candidates that would involve
devices impregnated with taurolidine, and we believe that at the current time such products would be combination products subject to both
device premarket submission requirements and drug regulations. Consequently, given that there is no appropriate predicate medical device
currently marketed in the U.S. on which a 510(k) clearance process could be based and that taurolidine is not yet approved in any application,
we anticipate that we would be required to submit a premarket approval application, or PMA, for marketing authorization for any medical
device indications that we may pursue for devices containing taurolidine. In the event that an NDA for DefenCath is approved by the FDA,
the regulatory pathway for these medical device product candidates may be revisited with the FDA. Although there may be no appropriate
predicate, de novo Class II designation can be proposed, based on a risk assessment and a reasonable assurance of safety and effectiveness.
In December 2019, the novel coronavirus disease,
COVID-19, was identified in Wuhan, China. This virus has been declared a pandemic and has spread to multiple global regions. The outbreak
and government measures taken in response have also had a significant impact, both direct and indirect, on businesses and commerce, as
worker shortages have occurred; supply chains have been disrupted; facilities and production have been suspended; and demand for certain
goods and services, such as medical services and supplies, has spiked, while demand for other goods and services, such as travel, has
fallen. In response to the COVID-19 outbreak, “shelter in place” orders and other public health guidance measures have been
implemented across much of the United States, Europe and Asia, including in the locations of our offices, clinical trial sites, key vendors
and partners. Such “shelter in place” orders were previously lifted, at least partially, in many locations. However, an increase
in the spread of COVID-19 and variants, which may reflect the spread of one or more successive waves of the virus, has led to the re-imposition
by many states of quarantine requirements for out-of-state travelers and may lead to the re-imposition of “shelter-in-place”
or other similar orders. Although several vaccines for prevention or mitigation of the severity of the virus have been granted Emergency
Use Authorization by the FDA and foreign regulatory authorities, the timely distribution and public acceptance thereof in reducing the
pandemic remain uncertain. Our clinical development program timelines may be negatively affected by COVID-19, which could materially and
adversely affect our business, financial condition and results of operations. Further, due to “shelter in place” orders and
other public health guidance measures, we have implemented a work-from-home policy for all staff members excluding those necessary to
maintain minimum basic operations. Our increased reliance on personnel working from home may negatively impact productivity, or disrupt,
delay or otherwise adversely impact our business.
Corporate History and Information
We were organized as a Delaware corporation on
July 28, 2006 under the name “Picton Holding Company, Inc.” and we changed our corporate name to “CorMedix Inc.”
on January 18, 2007. Our operations to date have been primarily limited to conducting clinical trials and establishing manufacturing for
our product candidates, licensing product candidates, business and financial planning, research and development, seeking regulatory approval
for our products, initial commercialization activities for DefenCath in the U.S. and Neutrolin in the EU and other foreign markets, and
maintaining and improving our patent portfolio.
Our executive offices are located at 300 Connell
Drive, Suite 4200, Berkeley Heights, NJ 07922. Our telephone number is (908) 517-9500. Our website address is www.cormedix.com. Information
contained in, or accessible through, our website does not constitute part of this prospectus.
Offerings Under This Prospectus
We may offer shares of our common stock and preferred
stock, various series of debt securities and/or warrants to purchase any of such securities, either individually or in units, up to an
indeterminate amount from time to time under this prospectus at prices and on terms to be determined by market conditions at the time
of any offering. This prospectus provides you with a general description of the securities we may offer. Each time we offer a type or
series of securities under this prospectus, we will provide a prospectus supplement that will describe the specific amounts, prices and
other important terms of the securities.
The prospectus supplement also may add, update
or change information contained in this prospectus or in documents we have incorporated by reference into this prospectus. However, no
prospectus supplement will fundamentally change the terms that are set forth in this prospectus or offer a security that is not registered
and described in this prospectus at the time of its effectiveness.
This prospectus may not be used to consummate
a sale of any securities unless it is accompanied by a prospectus supplement.
We may sell the securities directly to investors
or to or through agents, underwriters or dealers. We, and our agents or underwriters, reserve the right to accept or reject all or part
of any proposed purchase of securities. If we offer securities through agents or underwriters, we will include in the applicable prospectus
supplement:
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Common Stock
We may issue shares of our common stock from time
to time. The holders of common stock are entitled to one vote per share on all matters to be voted upon by stockholders. Subject to preferences
that may be applicable to any outstanding preferred stock, the holders of common stock are entitled to receive ratably any dividends that
may be declared from time to time by our board of directors out of funds legally available for that purpose. In the event of our liquidation,
dissolution or winding up, the holders of common stock are entitled to share ratably in all assets remaining after payment of liabilities,
subject to prior distribution rights of any preferred stock then outstanding.
Preferred Stock
We may issue shares of our preferred stock from
time to time, in one or more series. Our board of directors will determine the rights, preferences, privileges and restrictions of the
preferred stock, including dividend rights, conversion rights, voting rights, terms of redemption, liquidation preferences, sinking fund
terms and the number of shares constituting any series or the designation of such series, without any further vote or action by stockholders.
Convertible preferred stock will be convertible into our common stock or exchangeable for our other securities. Conversion may be mandatory
or at your option or both and would be at prescribed conversion rates.
If we sell any series of preferred stock under
this prospectus and applicable prospectus supplements, we will fix the rights, preferences, privileges and restrictions of the preferred
stock of such series in the certificate of designation relating to that series. We will file as an exhibit to the registration statement
of which this prospectus is a part, or will incorporate by reference from reports that we file with the SEC, the form of any certificate
of designation that describes the terms of the series of preferred stock we are offering before the issuance of the related series of
preferred stock. We urge you to read the applicable prospectus supplement related to the series of preferred stock being offered, as
well as the complete certificate of designation that contains the terms of the applicable series of preferred stock.
Warrants
We may issue warrants for the purchase of common
stock, preferred stock and/or debt securities in one or more series. We may issue warrants independently or together with common stock,
preferred stock and/or debt securities, and the warrants may be attached to or separate from these securities. We will evidence each series
of warrants by warrant certificates that we will issue under a separate agreement. We may enter into warrant agreements with a bank or
trust company that we select to be our warrant agent. We will indicate the name and address of the warrant agent in the applicable prospectus
supplement relating to a particular series of warrants.
In this prospectus, we have summarized certain
general features of the warrants. We urge you, however, to read the applicable prospectus supplement related to the particular series
of warrants being offered, as well as the warrant agreements and warrant certificates that contain the terms of the warrants. We will
file as exhibits to the registration statement of which this prospectus is a part, or will incorporate by reference from reports that
we file with the SEC, the form of warrant agreement or warrant certificate containing the terms of the warrants we are offering before
the issuance of the warrants.
Debt Securities
We may offer debt securities from time to time,
in one or more series, as either senior or subordinated debt or as senior or subordinated convertible debt. The senior debt securities
will rank equally with any other unsecured and unsubordinated debt. The subordinated debt securities will be subordinate and junior in
right of payment, to the extent and in the manner described in the instrument governing the debt, to all of our senior indebtedness. Convertible
debt securities will be convertible into or exchangeable for our common stock or our other securities. Conversion may be mandatory or
at your option or both and would be at prescribed conversion rates.
With respect to any debt securities that we issue,
we will issue such debt securities under an indenture, which we would enter into with the trustee named in the indenture. The form of
indenture was filed as an exhibit to the registration statement of which this prospectus is a part and is incorporated herein by reference.
Any indenture would be qualified under the Trust Indenture Act of 1939.
Units
We may issue units consisting of common stock,
preferred stock, debt securities and/or warrants for the purchase of common stock, preferred stock and/or debt securities in one or more
series. In this prospectus, we have summarized certain general features of the units. We urge you, however, to read the applicable prospectus
supplement related to the series of units being offered, as well as the unit agreements that contain the terms of the units. We will file
as exhibits to the registration statement of which this prospectus is a part, or will incorporate by reference reports that we file with
the SEC, the form of unit agreement and any supplemental agreements that describe the terms of the series of units we are offering before
the issuance of the related series of units.
RISK
FACTORS
An investment in our securities involves a high degree of risk. You
should carefully consider the risks, uncertainties and assumptions discussed under the heading “risk factors” included in
our most recent annual report on Form 10-K, as revised or supplemented by our subsequent quarterly reports on Form 10-Q on file with the
SEC and are incorporated herein by reference, and which may be amended, supplemented or superseded from time to time by other reports
we file with the SEC in the future. You should also consider the risks referred to above and all of the other information contained in
this prospectus and any accompanying prospectus supplement, and incorporated by reference into this prospectus and any accompanying prospectus
supplement, including our financial statements and related notes, before investing in our securities. If any of the possible events described
in those sections actually occur, our business, business prospects, cash flow, results of operations or financial condition could be harmed.
In this case, the trading price of our securities could decline, and you might lose all or part of your investment in our securities.
USE
OF PROCEEDS
We cannot assure you that we will receive any proceeds
in connection with securities offered by us pursuant to this prospectus. Unless otherwise provided in the applicable prospectus supplement,
we intend to use the net proceeds from the sale of our securities by us under this prospectus for general corporate purposes, including
obtaining regulatory approval and commercialization of DefenCath™ in the U.S., research and development, and working capital and
general expenditures. We will set forth in the applicable prospectus supplement our intended use for the net proceeds received from the
sale of any securities by us. Pending the application of the net proceeds, we intend to invest a portion of the net proceeds generally
in short-term, investment grade, interest-bearing securities.
PLAN
OF DISTRIBUTION
We may sell the securities from time to time by
a variety of methods, including:
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through one or more underwriters on a firm commitment or best-efforts basis; |
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directly to one or more purchasers; |
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through agents; |
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in options transactions; |
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over the Internet; |
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any other method permitted pursuant to applicable law; or |
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in any combination of the above. |
In effecting sales, brokers or dealers engaged
by us may arrange for other brokers or dealers to participate. Broker-dealer transactions may include:
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purchases of the securities by a broker-dealer as principal and resales of the securities by the broker-dealer for its account pursuant to this prospectus; |
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ordinary brokerage transactions; or |
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transactions in which the broker-dealer solicits purchasers. |
We may sell the securities to or through underwriters
or dealers, through agents, or directly to one or more purchasers. We may distribute securities from time to time in one or more transactions:
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at a fixed price or prices, which may be changed; |
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at market prices prevailing at the time of sale; |
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at prices related to such prevailing market prices; or |
Each prospectus supplement will describe the method
of distribution of the securities and any applicable restrictions.
A prospectus supplement or supplements (and any
related free writing prospectus that we may authorize to be provided to you) will describe the terms of the offering of the securities,
including, to the extent applicable:
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the name or names of the underwriters, if any; |
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the purchase price of the securities or other consideration therefor, and the proceeds, if any, we will receive from the sale; |
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any over-allotment options under which underwriters may purchase additional securities from us; |
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any agency fees or underwriting discounts and other items constituting agents’ or underwriters’ compensation; |
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any public offering price; |
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any discounts or concessions allowed or reallowed or paid to dealers; and |
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any securities exchange or market on which the securities may be listed. |
Only underwriters named in the prospectus supplement
will be underwriters of the securities offered by the prospectus supplement.
If underwriters are used in the sale, they will
acquire the securities for their own account and may resell the securities from time to time in one or more transactions at a fixed public
offering price or at varying prices determined at the time of sale. The obligations of the underwriters to purchase the securities will
be subject to the conditions set forth in the applicable underwriting agreement. We may offer the securities to the public through underwriting
syndicates represented by managing underwriters or by underwriters without a syndicate. Subject to certain conditions, the underwriters
will be obligated to purchase all of the securities offered by the prospectus supplement, other than securities covered by any over-allotment
option. Any public offering price and any discounts or concessions allowed or reallowed or paid to dealers may change from time to time.
We may use underwriters with whom we have a material relationship. We will describe in the prospectus supplement, naming the underwriter,
the nature of any such relationship.
We may sell securities directly or through agents
we designate from time to time. We will name any agent involved in the offering and sale of securities and we will describe any commissions
we will pay the agent in the prospectus supplement. Unless the prospectus supplement states otherwise, our agent will act on a best-efforts
basis for the period of its appointment.
We may authorize agents or underwriters to solicit
offers by certain types of institutional investors to purchase securities from us at the public offering price set forth in the prospectus
supplement pursuant to delayed delivery contracts providing for payment and delivery on a specified date in the future. We will describe
the conditions to these contracts and the commissions we must pay for solicitation of these contracts in the prospectus supplement.
We may provide agents and underwriters with indemnification
against civil liabilities, including liabilities under the Securities Act, or contribution with respect to payments that the agents or
underwriters may make with respect to these liabilities. Agents and underwriters may engage in transactions with, or perform services
for, us in the ordinary course of business.
All securities we may offer, other than common
stock, will be new issues of securities with no established trading market. Any underwriters may make a market in these securities, but
will not be obligated to do so and may discontinue any market making at any time without notice. We cannot guarantee the liquidity of
the trading markets for any securities.
Any underwriter may engage in over-allotment, stabilizing
transactions, short-covering transactions and penalty bids in accordance with Regulation M under the Exchange Act. Over-allotment
involves sales in excess of the offering size, which create a short position. Stabilizing transactions permit bids to purchase the underlying
security so long as the stabilizing bids do not exceed a specified maximum price. Syndicate-covering or other short-covering transactions
involve purchases of the securities, either through exercise of the over-allotment option or in the open market after the distribution
is completed, to cover short positions. Penalty bids permit the underwriters to reclaim a selling concession from a dealer when the securities
originally sold by the dealer are purchased in a stabilizing or covering transaction to cover short positions. Those activities may cause
the price of the securities to be higher than it would otherwise be. If commenced, the underwriters may discontinue any of the activities
at any time.
Any underwriters that are qualified market makers
on the Nasdaq Global Market may engage in passive market making transactions in the common stock on the Nasdaq Global Market in accordance
with Regulation M under the Exchange Act, during the business day prior to the pricing of the offering, before the commencement of
offers or sales of the common stock. Passive market makers must comply with applicable volume and price limitations and must be identified
as passive market makers. In general, a passive market maker must display its bid at a price not in excess of the highest independent
bid for such security; if all independent bids are lowered below the passive market maker’s bid, however, the passive market maker’s
bid must then be lowered when certain purchase limits are exceeded. Passive market making may stabilize the market price of the securities
at a level above that which might otherwise prevail in the open market and, if commenced, may be discontinued at any time.
DESCRIPTION
OF OUR CAPITAL STOCK
Common Stock
The following is a summary of certain provisions
of our capital stock. Such summary does not purport to be complete. You should refer to our Amended and Restated Certificate of Incorporation,
as amended, and our Second Amended and Restated Bylaws and each Certificate of Designation for our Series C-3, E and G preferred stock,
in each case, incorporated by reference as an exhibit to our most recent Form 10-K. The summary below is also qualified by provisions
of such documents and applicable law.
Pursuant to our Amended and Restated Certificate
of Incorporation, as amended, we are authorized to issue 160,000,000 shares of common stock, $0.001 par value per share. As of August
11, 2021, we had 38,086,437 shares of common stock outstanding.
The holders of our common stock are entitled to
one vote per share on all matters to be voted on by the stockholders, and there are no cumulative voting rights. Generally, all matters
to be voted on by stockholders must be approved by a majority (or, in the case of election of directors, by a plurality) of the votes
entitled to be cast by all shares of common stock present in person or represented by proxy, subject to any voting rights granted to holders
of any preferred stock.
The holders of common stock are entitled to receive
ratable dividends, if any, payable in cash, in stock or otherwise if, as and when declared from time to time by our Board of Directors
out of funds legally available for the payment of dividends, subject to any preferential rights that may be applicable to any outstanding
preferred stock. In the event of a liquidation, dissolution, or winding up of our Company, after payment in full of all outstanding debts
and other liabilities, the holders of common stock are entitled to share ratably in all remaining assets, subject to prior distribution
rights of preferred stock, if any, then outstanding. No shares of common stock have preemptive rights or other subscription rights to
purchase additional shares of common stock. There are no redemption or sinking fund provisions applicable to the common stock. All outstanding
shares of common stock are fully paid and nonassessable. The rights, preferences and privileges of holders of our common stock will be
subject to, and might be adversely affected by, the rights of holders of any preferred stock that we may issue in the future. All shares
of common stock that are acquired by us shall be available for reissuance by us at any time.
Issued and Outstanding Preferred Stock
Under the terms of our Amended and Restated Certificate
of Incorporation, as amended, our Board of Directors is authorized to issue up to 2,000,000 shares of preferred stock in one or more series
without stockholder approval. Our Board of Directors has the discretion to determine the rights, preferences, privileges and restrictions,
including voting rights, dividend rights, conversion rights, redemption privileges and liquidation preferences, of each series of preferred
stock. As of August 11, 2021 of the 2,000,000 shares of preferred stock authorized, our Board of Directors has designated (all with
par value of $0.001 per share): 200,000 shares as Series C-3 Non-Voting Convertible Preferred Stock; 89,623 shares as Series E Convertible
Preferred Stock and 100,000 as Series G Convertible Preferred Stock. As of August 11, 2021, we had outstanding: 2,000 shares of Series
C-3 Non-Voting Convertible Preferred Stock; 89,623 shares of Series E Convertible Preferred Stock and 89,999 shares of Series G Convertible
Preferred Stock.
Series C-3 Non-Voting Convertible Preferred Stock
The Series C-3 Preferred Stock has the rights,
privileges and terms described below.
Rank. The Series C-3 Preferred Stock will
rank:
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senior to our common stock; |
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senior to any class or series of capital stock created after the issuance of the Series C-3 Preferred Stock; and |
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junior to the Series E Convertible Preferred Stock, in each case, as to dividends or distributions of assets upon our liquidation, dissolution or winding up whether voluntarily or involuntarily. |
Conversion. Each share of Series C-3 Preferred
Stock is convertible into 2 shares of our common stock (subject to adjustment in the event of stock dividends and distributions, stock
splits, stock combinations, or reclassifications affecting our common stock) at a per share price of $5.00 at any time at the option of
the holder, except that a holder will be prohibited from converting shares of Series C-3 Preferred Stock into shares of common stock if,
as a result of such conversion, such holder, together with its affiliates, would beneficially own more than 9.99% of the total number
of shares of our common stock then issued and outstanding.
Liquidation Preference. In the event of
our liquidation, dissolution or winding up, holders of Series C-3 Preferred Stock will receive a payment equal to $10.00 per share of
Series C-3 Preferred Stock before any proceeds are distributed to the holders of our common stock. After the payment of this preferential
amount, and subject to the rights of holders of any class or series of our capital stock hereafter created specifically ranking by its
terms senior to the Series C-3 Preferred Stock, holders of Series C-3 Preferred Stock will participate ratably in the distribution of
any remaining assets with the common stock and any other class or series of our capital stock hereafter created that participates with
the common stock in such distributions.
Voting Rights. Shares of Series C-3 Preferred
Stock will generally have no voting rights, except as required by law and except that the consent of holders of two thirds of the outstanding
Series C-3 Preferred Stock will be required to amend the terms of the Series C-3 Preferred Stock or the certificate of designation for
the Series C-3 Preferred Stock.
Dividends. Holders of Series C-3 Preferred
Stock are entitled to receive, and we are required to pay, dividends on shares of the Series C-3 Preferred Stock equal (on an as-if-converted-to-common-stock
basis) to and in the same form as dividends (other than dividends in the form of common stock) actually paid on shares of the common stock
when, as and if such dividends (other than dividends in the form of common stock) are paid on shares of the common stock.
Redemption. We are not obligated to redeem
or repurchase any shares of Series C-3 Preferred Stock. Shares of Series C-3 Preferred Stock are not otherwise entitled to any redemption
rights, or mandatory sinking fund or analogous fund provisions.
Listing. There is no established public
trading market for the Series C-3 Preferred Stock, and we do not expect a market to develop. In addition, we do not intend to apply for
listing of the Series C-3 Preferred Stock on any national securities exchange or trading system.
Fundamental Transactions. If, at any time
that shares of Series C-3 Preferred Stock are outstanding, we effect a merger or other change of control transaction, as described in
the certificate of designation and referred to as a fundamental transaction, then a holder will have the right to receive, upon any subsequent
conversion of a share of Series C-3 Preferred Stock (in lieu of conversion shares) for each issuable conversion share, the same kind and
amount of securities, cash or property as such holder would have been entitled to receive upon the occurrence of such fundamental transaction
if such holder had been, immediately prior to such fundamental transaction, the holder of a share of common stock.
Series E Convertible Preferred Stock
Rank. The Series E Preferred Stock will
rank:
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senior to our common stock; |
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senior to the Series C-3 Non-Voting Convertible Preferred Stock; |
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on parity with the Series G Convertible Preferred Stock; and |
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senior to any class or series of capital stock created after the issuance of the Series E
Preferred Stock, in each case, as to dividends or distributions
of assets upon our liquidation, dissolution or winding up whether voluntarily or involuntarily. |
Conversion. Each share of Series E Preferred
Stock is convertible into 4.3733 shares of our common stock (subject to adjustment as provided in the certificates of designation for
the Series E Preferred Stock) at a per share price of $3.75 at any time at the option of the holder, except that a holder will be prohibited
from converting shares of Series E Preferred Stock into shares of common stock if, as a result of such conversion, such holder, together
with its affiliates, would beneficially own more than 4.99% of the total number of shares of our common stock then issued and outstanding.
Liquidation Preference. In the event of
our liquidation, dissolution or winding up, holders of Series E Preferred Stock will receive a payment equal to $49.20 per share of Series
E Preferred Stock on parity with the payment of the liquidation preference due the Series G Preferred Stock, but before any proceeds are
distributed to the holders of common stock, and the Series C-3 Preferred Stock. After the payment of this preferential amount, holders
of Series E Preferred Stock will participate ratably in the distribution of any remaining assets with the common stock and any other class
or series of our capital stock that participates with the common stock in such distributions.
Voting Rights. Shares of Series E Preferred
Stock are entitled to vote on an as-converted basis, based upon an assumed conversion price of $7.93.
Dividends. Holders of Series E Preferred
Stock are entitled to receive, and we are required to pay, dividends on shares of the Series E Preferred Stock equal (on an as-if-converted-to-common-stock
basis) to and in the same form as dividends (other than dividends in the form of common stock) actually paid on shares of the common stock
when, as and if such dividends (other than dividends in the form of common stock) are paid on shares of the common stock.
Redemption. We are not obligated to redeem
or repurchase any shares of Series E Preferred Stock. Shares of Series E Preferred Stock are not otherwise entitled to any redemption
rights, or mandatory sinking fund or analogous fund provisions.
Listing. There is no established public
trading market for the Series E Preferred Stock, and we do not expect a market to develop. In addition, we do not intend to apply for
listing of the Series E Preferred Stock on any national securities exchange or trading system.
Fundamental Transactions. If, at any time
that shares of Series E Preferred Stock are outstanding, we effect a merger or other change of control transaction, as described in the
certificate of designation and referred to as a fundamental transaction, then a holder will have the right to receive, upon any subsequent
conversion of a share of Series E Preferred Stock (in lieu of conversion shares) for each issuable conversion share, the same kind and
amount of securities, cash or property as such holder would have been entitled to receive upon the occurrence of such fundamental transaction
if such holder had been, immediately prior to such fundamental transaction, the holder of a share of common stock.
Debt Restriction. As long as any of the
Series E Preferred Stock is outstanding, we cannot create, incur, guarantee, assume or suffer to exist any indebtedness, other than (i)
trade payables incurred in the ordinary course of business consistent with past practice, and (ii) up to $10 million aggregate principal
amount of indebtedness with a maturity less than twelve months outstanding at any time, which amount may include up to $5 million of letters
of credit outstanding at any time.
Other Covenants. In
addition to the debt restrictions above, as long as any the Series E Preferred Stock is outstanding, we cannot, among others things: create,
incur, assume or suffer to exist any encumbrances on any of our assets or property; redeem, repurchase or pay any cash dividend or distribution
on any of our capital stock (other than as permitted, which includes the dividends on the Series E Preferred Stock and Series G Preferred
Stock); redeem, repurchase or prepay any indebtedness (other than as permitted); or engage in any material line of business substantially
different from our current lines of business.
Purchase Rights. In the event we issue any
options, convertible securities or rights to purchase stock or other securities pro rata to the holders of common stock, then a holder
of Series E Preferred Stock will be entitled to acquire, upon the same terms a pro rata amount of such stock or securities as if the Series
E Preferred Stock had been converted to common stock.
Series G Convertible Preferred Stock
Rank. The Series G Preferred Stock will
rank:
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senior to our common stock; |
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senior to any class or series of capital stock created after the issuance of the Series G Preferred Stock; |
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junior to the Series C-3 Non-Voting Convertible Preferred Stock, pending the consent of the holders of such series to the subordination thereof; and |
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on parity with the Series E Convertible Preferred Stock, in each case, as to dividends or distributions
of assets upon our liquidation, dissolution or winding up whether voluntarily or involuntarily. |
Conversion. Each share of Series G Preferred
Stock is convertible into approximately 55.5978 shares of our common stock (subject to adjustment as provided in the certificate of designation
for the Series G Preferred Stock) at a per share price of $3.37 at any time at the option of the holder, except that a holder will be
prohibited from converting shares of Series G Preferred Stock into shares of common stock if, as a result of such conversion, such holder,
together with its affiliates, would beneficially own more than 4.99% of the total number of shares of our common stock then issued and
outstanding.
Liquidation Preference. In the event of
our liquidation, dissolution or winding up, holders of Series E Preferred Stock will receive a payment equal to $187.36452 per share of
Series G Preferred Stock on parity with the payment of the liquidation preference due the Series E Preferred Stock, but before any proceeds
are distributed to the holders of Series C-3 Preferred Stock (pending the consent of the holders of such series to the subordination thereof)
and after any proceeds are distributed to the holders of common stock. After the payment of this preferential amount, holders of Series
G Preferred Stock will participate ratably in the distribution of any remaining assets with the common stock and any other class or series
of our capital stock that participates with the common stock in such distributions.
Voting Rights. Shares of Series G Preferred
Stock are entitled to vote on an as-converted basis, based upon an assumed conversion price of $7.93.
Dividends. Holders of Series G Preferred
Stock are entitled to receive, and we are required to pay, dividends on shares of the Series G Preferred Stock equal (on an as-if-converted-to-common-stock
basis) to and in the same form as dividends (other than dividends in the form of common stock) actually paid on shares of the common stock
when, as and if such dividends (other than dividends in the form of common stock) are paid on shares of the common stock.
Redemption. We are not obligated to redeem
or repurchase any shares of Series G Preferred Stock. Shares of Series G Preferred Stock are not otherwise entitled to any redemption
rights, or mandatory sinking fund or analogous fund provisions.
Listing. There is no established public
trading market for the Series G Preferred Stock, and we do not expect a market to develop. In addition, we do not intend to apply for
listing of the Series G Preferred Stock on any national securities exchange or trading system.
Fundamental Transactions. If, at any time
that shares of Series G Preferred Stock are outstanding, we effect a merger or other change of control transaction, as described in the
certificate of designation and referred to as a fundamental transaction, then a holder will have the right to receive, upon any subsequent
conversion of a share of Series G Preferred Stock (in lieu of conversion shares) for each issuable conversion share, the same kind and
amount of securities, cash or property as such holder would have been entitled to receive upon the occurrence of such fundamental transaction
if such holder had been, immediately prior to such fundamental transaction, the holder of a share of common stock.
Debt Restriction. As long as any of the
Series G Preferred Stock is outstanding, we cannot create, incur, guarantee, assume or suffer to exist any indebtedness, other than (i)
trade payables incurred in the ordinary course of business consistent with past practice, and (ii) up to $10 million aggregate principal
amount of indebtedness with a maturity less than twelve months outstanding at any time, which amount may include up to $5 million of letters
of credit outstanding at any time.
Other Covenants. In addition to the debt
restrictions above, as long as any the Series G Preferred Stock is outstanding, we cannot, among others things: create, incur, assume
or suffer to exist any encumbrances on any of our assets or property; redeem, repurchase or pay any cash dividend or distribution on any
of our capital stock (other than as permitted, which includes the dividends on the Series E Preferred Stock and the Series G Preferred
Stock); redeem, repurchase or prepay any indebtedness (other than as permitted); or engage in any material line of business substantially
different from our current lines of business.
Purchase Rights. In the event we issue any
options, convertible securities or rights to purchase stock or other securities pro rata to the holders of common stock, then a holder
of Series G Preferred Stock will be entitled to acquire, upon the same terms a pro rata amount of such stock or securities as if the Series
G Preferred Stock had been converted to common stock.
Transfer Agent and Registrar
We act as our own transfer agent and registrar
for the Series C-3, E and G Preferred Stock.
Description of Preferred Stock That May Be Offered
Our board of directors has the authority, without
further action by the stockholders, to issue up to 2,000,000 shares of preferred stock in one or more series and to fix the rights, preferences,
privileges and restrictions thereof, including dividend rights, conversion rights, voting rights, terms of redemption, liquidation preferences,
sinking fund terms and the number of shares constituting any series or the designation of such series, without any further vote or action
by our stockholders. The shares of preferred stock outstanding are described above. The issuance of new or additional preferred stock
could adversely affect the voting power of holders of common stock and the likelihood that such holders will receive dividend payments
and payments upon liquidation and could have the effect of delaying, deferring or preventing a change in control of our company.
We will fix the rights, preferences, privileges
and restrictions of any new series of preferred stock in the certificate of designation relating to that series. We will file as an exhibit
to the registration statement of which this prospectus is a part, or will incorporate by reference from reports that we file with the
SEC, the form of any certificate of designation that describes the terms of the series of preferred stock we are offering before the issuance
of the related series of preferred stock. This description will include any or all of the following, as required:
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the title and stated value; |
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the number of shares we are offering; |
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the liquidation preference per share; |
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the dividend rate, period and payment date and method of calculation for dividends; |
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whether dividends will be cumulative or non-cumulative and, if cumulative, the date from which dividends will accumulate; |
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the procedures for any auction and remarketing, if any; |
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the provisions for a sinking fund, if any; |
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the provisions for redemption or repurchase, if applicable, and any restrictions on our ability to exercise those redemption and repurchase rights; |
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any listing of the preferred stock on any securities exchange or market; |
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whether the preferred stock will be convertible into our common stock, and, if applicable, the conversion price, or how it will be calculated, and the conversion period; |
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whether the preferred stock will be exchangeable into debt securities, and, if applicable, the exchange price, or how it will be calculated, and the exchange period; |
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voting rights, if any, of the preferred stock; |
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preemptive rights, if any; |
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restrictions on transfer, sale or other assignment, if any; |
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whether interests in the preferred stock will be represented by depositary shares; |
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a discussion of any material or special United States federal income tax considerations applicable to the preferred stock; |
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the relative ranking and preferences of the preferred stock as to dividend rights and rights if we liquidate, dissolve or wind up our affairs; |
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any limitations on issuance of any class or series of preferred stock ranking senior to or on a parity with the series of preferred stock as to dividend rights and rights if we liquidate, dissolve or wind up our affairs; and |
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any other specific terms, preferences, rights or limitations of, or restrictions on, the preferred stock. |
If we issue shares of preferred stock under this
prospectus, the shares will be fully paid and non-assessable.
The General Corporation Law of the State of Delaware,
the state of our incorporation, provides that the holders of preferred stock will have the right to vote separately as a class on any
proposal involving fundamental changes in the rights of holders of that preferred stock. This right is in addition to any voting rights
that may be provided for in the applicable certificate of designation.
Our board of directors may authorize the issuance
of preferred stock with voting or conversion rights that could adversely affect the voting power or other rights of the holders of our
common stock. Preferred stock could be issued quickly with terms designed to delay or prevent a change in control of our company or make
removal of management more difficult. Additionally, the issuance of preferred stock may have the effect of decreasing the market price
of our common stock.
Certain
Anti-Takeover Provisions of Delaware Law and of Our Amended and Restated Certificate of Incorporation and Second Amended and Restated
Bylaws
Certain provisions of the Delaware General Corporation
Law (the “DGCL”) and our Amended and Restated Certificate of Incorporation, as amended, and our Second Amended and Restated
Bylaws discussed below may have the effect of making more difficult or discouraging a tender offer, proxy contest or other takeover attempt.
These provisions are expected to encourage persons seeking to acquire control of our Company to first negotiate with our Board of Directors.
We believe that the benefits of increasing our ability to negotiate with the proponent of an unfriendly or unsolicited proposal to acquire
or restructure our Company outweigh the disadvantages of discouraging these proposals because negotiation of these proposals could result
in an improvement of their terms.
Delaware Anti-takeover Law
We are subject to Section 203 of the DGCL, an anti-takeover
law. In general, Section 203 prohibits a publicly held Delaware corporation from engaging in a “business combination” with
an “interested stockholder” for a period of three years following the date the person became an interested stockholder, unless:
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the Board of Directors approves the transaction in which the stockholder became an interested stockholder prior to the date the interested stockholder attained that status; |
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when the stockholder became an interested stockholder, he or she owned at least 85% of the voting stock of the corporation outstanding at the time the transaction commenced, excluding shares owned by persons who are directors and also officers and certain shares owned by employee benefits plans; or |
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on or subsequent to the date the business combination is approved by the Board of Directors, the business combination is authorized by the affirmative vote of at least 66 2/3% of the voting stock of the corporation at an annual or special meeting of stockholders. |
Generally, a “business combination”
includes a merger, asset or stock sale, or other transaction resulting in a financial benefit to the interested stockholder. Generally,
an “interested stockholder” is a person who, together with affiliates and associates, owns, or is an affiliate or associate
of the corporation and within three years prior to the determination of interested stockholder status did own, 15% or more of a corporation’s
voting stock.
The existence of Section 203 of the DGCL would
be expected to have an anti-takeover effect with respect to transactions not approved in advance by our Board of Directors, including
discouraging attempts that might result in a premium over the market price for the shares of our common stock.
Charter Documents
Our Amended and Restated Certificate of Incorporation,
as amended, and Second Amended and Restated Bylaws include a number of provisions that may have the effect of deterring hostile takeovers
or delaying or preventing changes in control or management of our Company. First, our Second Amended and Restated Bylaws limit who may
call special meetings of the stockholders, such meetings may only be called by the chairman of the Board of Directors, the chief executive
officer, the Board of Directors or holders of an aggregate of at least 15% of our outstanding entitled to vote. Second, our Amended and
Restated Certificate of Incorporation does not include a provision for cumulative voting for directors. Under cumulative voting, a minority
stockholder holding a sufficient percentage of a class of shares may be able to ensure the election of one or more directors. Third, our
Second Amended and Restated Bylaws provide that the number of directors on our Board of Directors, which may range from five to nine directors,
shall be exclusively fixed by our Board of Directors, which has set the number of directors at seven. Fourth, newly created directorships
resulting from any increase in our authorized number of directors and any vacancies in our Board of Directors resulting from death, resignation,
retirement, disqualification or other cause (including removal from office by a vote of the shareholders) will be filled by a majority
of our Board of Directors then in office. Finally, our Second Amended and Restated Bylaws establish procedures, including 90-day advance
notice requirement, with regard to the nomination of candidates for election as directors and stockholder proposals. These and other provisions
of our Amended and Restated Certificate of Incorporation and Second Amended and Restated Bylaws and Delaware law could discourage potential
acquisition proposals and could delay or prevent a change in control or management of our Company.
DESCRIPTION
OF DEBT SECURITIES
The following description, together with the additional
information we include in any applicable prospectus supplement, summarizes the material terms and provisions of any debt securities that
we may offer under this prospectus. While the terms we have summarized below will apply generally to any future debt securities we may
offer, we will describe the particular terms of any debt securities that we may offer in more detail in the applicable prospectus supplement.
The terms of any debt securities we may offer under a prospectus supplement may differ from the terms described below. For any debt securities
that we may offer, an indenture (and any relevant supplemental indenture), if required, will contain additional important terms and provisions,
the form of which we filed as an exhibit to the registration statement of which this prospectus is a part and is incorporated therein
by reference. We will file any definitive indenture as an exhibit to reports that we file with the SEC and incorporate by reference in
this prospectus and the applicable prospectus supplement. Any indenture would be qualified under the Trust Indenture Act of 1939.
With respect to any debt securities that we issue,
we will describe in each prospectus supplement the following terms relating to a series of debt securities:
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the principal amount being offered, and if a series, the total amount authorized and the total amount outstanding; |
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any limit on the amount that may be issued; |
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whether or not we will issue the series of debt securities in global form, and if so, the terms and who the depository will be; |
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the principal amount due at maturity; |
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whether and under what circumstances, if any, we will pay additional amounts on any debt securities held by a person who is not a United States person for tax purposes, and whether we can redeem the debt securities if we have to pay such additional amounts; |
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the annual interest rate, which may be fixed or variable, or the method for determining the rate and the date interest will begin to accrue, the dates interest will be payable and the regular record dates for interest payment dates or the method for determining such dates; |
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whether or not the debt securities will be convertible into shares of our common stock or our preferred stock and, if so, the terms of such conversion; |
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whether or not the debt securities will be secured or unsecured by some or all of our assets, and the terms of any secured debt; |
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the terms of the subordination of any series of subordinated debt; |
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the place where payments will be payable; |
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restrictions on transfer, sale or other assignment, if any; |
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our right, if any, to defer payment or interest and the maximum length of any such deferral period; |
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the date, if any, after which and the conditions upon which, and the price at which, we may, at our option, redeem the series of debt securities pursuant to any optional or provisional redemption provisions and the terms of those redemptions provisions; |
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the date, if any, on which, and the price at which we are obligated, pursuant to any mandatory sinking fund or analogous fund provisions or otherwise, to redeem, or at the holder’s option to purchase, the series of debt securities and the currency or currency unit in which the debt securities are payable; |
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whether the indenture will restrict our ability to pay dividends, or will require us to maintain any asset ratios or reserves; |
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whether we will be restricted from incurring any additional indebtedness, issuing additional securities, or entering into a merger, consolidation or sale of our business; |
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a discussion of any material or special United States federal income tax considerations applicable to the debt securities; |
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information describing any book-entry features; |
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any provisions for payment of additional amounts for taxes; |
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whether the debt securities are to be offered at a price such that they will be deemed to be offered at an “original issue discount” as defined in paragraph (a) of Section 1273 of the Internal Revenue Code of 1986, as amended; |
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the denominations in which we will issue the series of debt securities, if other than denominations of $1,000 and any integral multiple thereof; |
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whether we and/or the indenture trustee may change an indenture without the consent of any holders; |
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the form of debt security and how it may be exchanged and transferred; |
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description of the indenture trustee and paying agent, and the method of payments; and |
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any other specified terms, preferences, rights or limitations of, or restrictions on, the debt securities and any terms that may be required by us or advisable under applicable laws or regulations. |
We summarize below the material terms of the form
of indenture, if required, or indicate which material terms will be described in the applicable prospectus supplement. The indenture:
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does not limit the amount of debt securities that we may issue; |
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allows us to issue debt securities in one or more series; |
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does not require us to issue all of the debt securities of a series at the same time; |
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allows us to reopen a series to issue additional debt securities without the consent of the holders of the debt securities of such series; and |
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provides that the debt securities will be unsecured, except as may be set forth in the applicable prospectus supplement. |
DESCRIPTION OF WARRANTS
The following description, together with the additional
information we may include in any applicable prospectus supplement, summarizes the material terms and provisions of any warrants that
we may offer under this prospectus and the related warrant agreements and warrant certificates. While the terms summarized below will
apply generally to any warrants that we may offer, we will describe the particular terms of any series of warrants in more detail in the
applicable prospectus supplement. The terms of any warrants offered under a prospectus supplement may differ from the terms described
below. With respect to any warrants that we offer, specific warrant agreements will contain additional important terms and provisions
and will be incorporated by reference as an exhibit to the registration statement that includes this prospectus or as an exhibit to reports
that we file with the SEC and incorporated by reference in this prospectus:
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the specific designation and aggregate number of, and the price at which we will issue, the warrants; |
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the currency or currency units in which the offering price, if any, and the exercise price are payable; |
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if applicable, the exercise price for shares of our common stock or preferred stock and the number of shares of common stock or preferred stock to be received upon exercise of the warrants; |
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in the case of warrants to purchase debt securities, the principal amount of debt securities purchasable upon exercise of one warrant and the price at, and currency in which, this principal amount of debt securities may be purchased upon such exercise; |
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the date on which the right to exercise the warrants will begin and the date on which that right will expire or, if you may not continuously exercise the warrants throughout that period, the specific date or dates on which you may exercise the warrants; |
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whether the warrants will be issued in fully registered form or bearer form, in definitive or global form or in any combination of these forms, although, in any case, the form of a warrant included in a unit will correspond to the form of the unit and of any security included in that unit; |
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any applicable material U.S. federal income tax consequences; |
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the identity of the warrant agent for the warrants and of any other depositaries, execution or paying agents, transfer agents, registrars or other agents; |
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the proposed listing, if any, of the warrants or the common stock issuable upon exercise of the warrants on any securities exchange; |
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if applicable, the date from and after which the warrants and the common stock will be separately transferable; |
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if applicable, the minimum or maximum amount of the warrants that may be exercised at any one time; |
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information with respect to book-entry procedures, if any; |
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the anti-dilution provisions of the warrants, if any; |
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any redemption or call provisions; |
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whether the warrants are to be sold separately or with other securities as parts of units; and |
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any additional terms of the warrants, including terms, procedures and limitations relating to the exchange and exercise of the warrants. |
Before exercising their warrants, holders of warrants
will not have any of the rights of holders of the securities purchasable upon such exercise, including:
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in the case of warrants to purchase debt securities, the right to receive payments of principal of, or premium, if any, or interest on, the debt securities purchasable upon exercise or to enforce covenants in the applicable indenture; or |
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in the case of warrants to purchase common stock or preferred stock, the right to receive dividends, if any, or, payments upon our liquidation, dissolution or winding up or to exercise voting rights, if any. |
Transfer Agent and Registrar
The transfer agent and registrar for any warrants
will be set forth in the applicable prospectus supplement.
DESCRIPTION
OF UNITS
We might issue units composed of one or more debt
securities, shares of common stock, shares of preferred stock and warrants in any combination. Each unit will be issued so that the holder
of the unit is also the holder of each security included in the unit. Thus, the holder of a unit will have the rights and obligations
of a holder of each included security. The unit agreement under which a unit is issued may provide that the securities included in the
unit may not be held or transferred separately, at any time or at any time before a specified date. We will file as exhibits to the registration
statement of which this prospectus is a part, or will incorporate by reference from reports that we file with the SEC, the form of unit
agreement, warrant and any supplemental agreements that describe the terms of the series of units we are offering before the issuance
of the related series of units.
We may choose to evidence each series of units
by unit certificates that we would issue under a separate agreement. If we choose to evidence the units by unit certificates, we will
enter into the unit agreements with a unit agent and will indicate the name and address of the unit agent in the applicable prospectus
supplement relating to the particular series of units.
LEGAL
MATTERS
Certain legal matters with respect to the securities
offered hereby have been passed upon by Morgan, Lewis & Bockius LLP, New York, New York.
EXPERTS
The consolidated balance sheets of CorMedix Inc. as
of December 31, 2020 and 2019 and the related consolidated statements of operations and comprehensive income (loss), stockholders’
equity, and cash flows for each of the years in the two-year period ended December 31, 2020, have been incorporated herein by reference
in reliance on the report of Friedman LLP, independent registered public accounting firm, given upon their authority as experts in accounting
and auditing.
WHERE YOU CAN FIND ADDITIONAL INFORMATION
We are required to file annual and quarterly reports,
current reports, proxy statements, and other information with the SEC. We make these documents publicly available, free of charge, on
our website at www.cormedix.com as soon as reasonably practicable after filing such documents with the SEC. Any requests for this information
should be made by calling or sending a letter to the Secretary of the Company, c/o CorMedix Inc., at our office located at 300 Connell
Drive, Suite 4200, Berkeley Heights, NJ 07922.
SEC filings are also available at the SEC’s
web site at http://www.sec.gov. Our common stock is listed on the Nasdaq Global Market, and you can read and inspect our filings at the
offices of the Nasdaq Global Market at 151 W. 42nd Street, New York, NY 10036.
INCORPORATION
OF DOCUMENTS BY REFERENCE
The SEC allows us to “incorporate by reference”
information that we file with them. Incorporation by reference allows us to disclose important information to you by referring you to
those other documents. The information incorporated by reference is an important part of this prospectus and any applicable accompanying
prospectus supplement, and information that we file later with the SEC will automatically update and supersede this information. We filed
a registration statement on Form S-3 under the Securities Act of 1933, as amended, with the SEC with respect to the securities being
offered pursuant to this prospectus and any applicable accompanying prospectus supplement. This prospectus omits certain information
contained in the registration statement, as permitted by the SEC. You should refer to the registration statement, including the exhibits,
for further information about us and the securities being offered pursuant to this prospectus and any applicable accompanying prospectus
supplement. Statements in this prospectus and any applicable accompanying prospectus supplement regarding the provisions of certain documents
filed with, or incorporated by reference in, the registration statement are not necessarily complete and each statement is qualified
in all respects by that reference. Copies of all or any part of the registration statement, including the documents incorporated by reference
or the exhibits, may be obtained as described above in “Where You Can Find More Information.” The documents we are incorporating
by reference into this prospectus are:
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our Annual Report on Form 10-K for the fiscal year ended December 31, 2020, filed with the SEC pursuant to Section 13 of the Exchange Act on March 30, 2021; |
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our Quarterly Reports on Form 10-Q for the quarter ended March 31, 2021, filed with the SEC on May 13, 2021 and for the quarter ended June 30, 2021, filed with the SEC on August 12, 2021; |
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the description of our capital stock contained in Exhibit 4.5 to our Annual Report on Form 10-K filed with the SEC on March 30, 2021, including any amendment or report filed for the purpose of updating such description; and |
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all of the filings pursuant to the Exchange Act after the date of the filing of the registration statement and prior to the effectiveness of the registration statement. |
In addition, all documents subsequently filed by
us after the date of the initial registration statement pursuant to Section 13(a), 13(c), 14 or 15(d) of the Exchange Act before
the date our offering is terminated or completed are deemed to be incorporated by reference into, and to be a part of, this prospectus.
Any statement contained in this prospectus and
any applicable prospectus supplement or in a document incorporated or deemed to be incorporated by reference into this prospectus and
any applicable prospectus supplement will be deemed to be modified or superseded for purposes of this prospectus and any prospectus supplement
to the extent that a statement contained in this prospectus and any applicable prospectus supplement or any other subsequently filed document
that is deemed to be incorporated by reference into this prospectus and any applicable prospectus supplement modifies or supersedes the
statement. Any statement so modified or superseded will not be deemed, except as so modified or superseded, to constitute a part of this
prospectus and any applicable prospectus supplement.
We will furnish without charge to you, on written
or oral request, a copy of any or all of the documents incorporated by reference, including exhibits to these documents. You should direct
any requests for documents to CorMedix, Inc., Attention: Secretary, 300 Connell Drive, Suite 4200, Berkeley Heights, New Jersey 07922,
(908) 517-9500.
You should rely only on information contained
in, or incorporated by reference into, this prospectus and any applicable prospectus supplement. We have not authorized anyone to provide
you with information different from that contained in this prospectus and any applicable prospectus supplement or incorporated by reference
in this prospectus and any applicable prospectus supplement. 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 offer or solicitation.
Shares
of Common Stock and
Pre-Funded Warrants to Purchase Up to Shares
of Common Stock
Shares of Common Stock
Underlying the Pre-Funded Warrants
PROSPECTUS SUPPLEMENT
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Book-Running
Managers |
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RBC
Capital Markets |
Truist
Securities |
JMP Securities
A
CITIZENS COMPANY |
, 2023
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