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UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
WASHINGTON, DC 20549
FORM 8-K
CURRENT REPORT
Pursuant to Section 13 or 15(d) of the
Securities Exchange Act of 1934
Date of report (Date of earliest event reported):
December 18, 2023
|
First Wave BioPharma, Inc. |
|
|
(Exact name of registrant as specified in its charter) |
|
Delaware |
|
001-37853 |
|
46-4993860 |
(State or other jurisdiction of incorporation) |
|
(Commission File Number) |
|
(IRS Employer Identification No.) |
777 Yamato Road, Suite 502
Boca Raton, Florida |
|
33431 |
(Address of principal executive offices) |
|
(Zip Code) |
Registrant’s telephone number, including
area code: (561) 589-7020
Not Applicable
(Former name or former address, if changed since
last report)
Check the appropriate box below if the Form 8-K
filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions:
¨ |
Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425) |
¨ |
Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12) |
¨ |
Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b)) |
¨ |
Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c)) |
Securities registered pursuant to Section 12(b)
of the Act:
Title of each class |
|
Trading Symbol(s) |
|
Name of each exchange on which
registered |
Common Stock, par value $0.0001 per share |
|
FWBI |
|
Nasdaq Capital Market |
Indicate by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (§230.405
of this chapter) or Rule 12b-2 of the Securities Exchange Act of 1934 (§240.12b-2 of this chapter).
Emerging growth company ¨
If an emerging growth company, indicate by check
mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting
standards provided pursuant to Section 13(a) of the Exchange Act. ¨
On
December 18, 2023, First Wave BioPharma, Inc. (the “Company”) announced it has entered into a non-binding letter of intent
(the “LOI”) for a proposed acquisition with ImmunogenX, Inc. (“IMGX”), a clinical-stage biotherapeutics company
developing Phase 3-ready latiglutenase, a targeted, oral biotherapeutic for celiac disease. Pursuant to the LOI, the Company would acquire
100% of the outstanding equity of IMGX on a fully diluted basis and, after stockholder approval of the proposed transaction, the shareholders
of IMGX will own a majority of the equity interests of the combined company (the “Acquisition”). Following the close of the
proposed Acquisition, James Sapirstein is expected to continue serving as Chairman and Chief Executive Officer with Jack Syage, Ph.D.,
Chief Executive Officer and Co-Founder of IMGX, assuming the role of President and Chief Operating Officer, with the combined company
focused on advancing a GI pipeline comprised of multiple late-stage clinical assets, including latiglutenase and capeserod. Operational
and financial leadership positions will be comprised of current First Wave Biopharma executives, while clinical, regulatory affairs, and
scientific positions will be led by executives of IMGX. The Company additionally anticipates concurrent financings and a strategic licensing
agreement for latiglutenase to occur after the close of the Acquisition.
The
LOI is subject to an exclusivity payment by the Company, upon execution of the LOI, of $500,000. The LOI only represents a mutual indication
of interest regarding the Acquisition and the terms of the Acquisition are subject to a number of contingencies, including the completion
of customary due diligence and the negotiation and execution of definitive agreements.
A
copy of the press release is attached as Exhibit 99.1 to this Current Report on Form 8-K and incorporated herein by reference.
Item 9.01 |
Financial Statements and Exhibits. |
(d) Exhibits
The
following exhibits are being filed or furnished, as applicable, with this Current Report on Form 8-K:
SIGNATURES
Pursuant to the requirements of the Securities
Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.
|
First Wave BioPharma, Inc. |
|
|
December 18, 2023 |
By: |
/s/ James Sapirstein |
|
Name: |
James Sapirstein |
|
Title: |
Chief Executive Officer |
Exhibit 99.1
First Wave BioPharma
Announces Entry into Term Sheet for Business Combination with ImmunogenX Establishing a Leading Late-Stage GI-Focused Biopharmaceutical
Company
Phase 3-ready latiglutenase,
a targeted oral biotherapeutic for celiac disease, will expand First Wave BioPharma’s late-stage gastrointestinal (GI) disease clinical
pipeline
A concurrent institutional
investment and a strategic U.S. license agreement with a global pharmaceutical company is anticipated to be completed post-closing
BOCA RATON, FL., December
18, 2023 – First Wave BioPharma, Inc., (NASDAQ: FWBI), (“First Wave BioPharma” or the “Company”), a
clinical-stage biopharmaceutical company specializing in the development of targeted, non-systemic therapies for gastrointestinal
(GI) diseases, today announced that the company has signed a non-binding term sheet for a business combination with ImmunogenX, a clinical-stage
biotherapeutics company developing Phase 3-ready latiglutenase, a potentially first-in-class, targeted, oral biotherapeutic for celiac
disease. Pursuant to the term sheet, First Wave BioPharma will acquire ImmunogenX in an all-stock transaction with the combined company
focused on advancing a GI pipeline comprised of multiple late-stage clinical assets, including latiglutenase and capeserod, which First
Wave BioPharma recently in-licensed from Sanofi. Following consummation of the transaction, First Wave BioPharma will continue to trade
on Nasdaq under the ticker symbol “FWBI”. The transaction, which has been approved by the Boards of Directors of both companies,
is subject to the negotiation and execution of definitive documentation, approval of the stockholders of both First Wave BioPharma and
ImmunogenX and other customary closing conditions and is expected to close in the first half of 2024.
Following the closing,
James Sapirstein will continue to serve as Chairman and Chief Executive Officer of First Wave BioPharma with Jack Syage, Ph.D., Chief
Executive Officer and Co-Founder of ImmunogenX, assuming the role of President and Chief Operating Officer. Operational and financial
leadership positions will be comprised of current First Wave BioPharma executives, while clinical, regulatory affairs, and scientific
positions will be led by executives of ImmunogenX. First Wave BioPharma anticipates a significant non-dilutive financial investment from
a strategic global pharmaceutical company for commercial rights to latiglutenase in the United States, in addition to financing commitments
from several institutional investors to fund development, will be completed post-closing.
“A business combination
with ImmunogenX will be a transformational event for First Wave as it will provide our company with a Phase 3-ready asset, latiglutenase,
and scientific, medical, and regulatory experts from ImmunogenX, led by Dr. Jack Syage and by Professor Chaitan Khosla, who completed
the seminal work leading to the discovery of latiglutenase at his laboratory at Stanford University,” stated Mr. Sapirstein. “Latiglutenase
has the potential to be a first-to-market treatment for celiac disease, a GI-disorder that impacts approximately three million people
in the U.S. and for which no approved pharmacologic treatment currently exists. Upon the closing of the business combination and concurrent
financing and licensing transaction, we plan to immediately advance the regulatory, manufacturing, and clinical processes that would enable
the initiation of the pivotal Phase 3 clinical trials of latiglutenase by the second half of 2024. This trajectory could enable latiglutenase
to enter the multibillion-dollar celiac disease market by 2027.”
Latiglutenase is an orally
administered mixture of two minimally systemically absorbed gluten-specific recombinant proteases being developed as an oral biotherapeutic
for celiac disease. In Phase 2a and 2b clinical trials, latiglutenase was shown to mitigate gluten-induced intestinal mucosal injury as
well as reduce the severity and frequency of symptoms in celiac disease patients. The Phase 3 clinical development plan for latiglutenase
has been reviewed by the GI Division of the U.S. Food and Drug Administration (FDA) at the End of Phase 2 meeting with an agreed plan
forward, with initiation of the Phase 3 trials expected in the second half of 2024.
Celiac disease is a chronic,
hereditary autoimmune and inflammatory disease triggered by gluten consumption. Celiac disease is characterized by damage to the lining
of the small intestine, causing malabsorption, gastrointestinal dysfunction and debilitating symptoms. Over the course of a lifetime,
untreated or poorly managed celiac disease is often associated with deteriorating general health, multiple serious intestinal and extra-intestinal
medical complications, and increased morbidity and mortality. Celiac disease is a global disease and affects approximately 1% of the population
worldwide and is increasing in prevalence with improved diagnostic tools and improved awareness.
“We are excited
to align with First Wave BioPharma and join in the Company’s mission to be a leading developer of non-systemic therapeutics to treat
GI diseases and bring relief to patients living daily with the often painful, dangerous, and discomforting symptoms inherent to such diseases,
including celiac disease,” stated Dr. Syage. “Data from our Phase 2 program investigating latiglutenase suggest the drug is
well-tolerated and can degrade key gluten proteins, which are known to cause gluten-induced intestinal mucosal injury and trigger the
symptoms of celiac disease. This merger transaction with First Wave will bring vital backing to drive the latiglutenase program, for which
we have garnered significant support from the NIH, including grant funding, and encouragement from the FDA.”
Tungsten Advisors is serving as the exclusive
financial advisor to First Wave BioPharma.
About First Wave BioPharma, Inc.
First Wave BioPharma is a clinical-stage biopharmaceutical
company specializing in the development of targeted, non-systemic therapies for gastrointestinal (GI) diseases. The Company is currently
advancing a therapeutic development pipeline with multiple late-stage clinical programs built around three proprietary technologies –
the biologic adrulipase, a recombinant lipase enzyme designed to enable the digestion of fats and other nutrients in cystic fibrosis and
chronic pancreatitis patients with exocrine pancreatic insufficiency; capeserod, a selective 5-HT4 receptor partial agonist which First
Wave will pursue for gastrointestinal (GI) indications; and niclosamide, an oral small molecule with anti-inflammatory properties for
patients with inflammatory bowel diseases such as ulcerative colitis and Crohn’s disease. First Wave BioPharma is headquartered
in Boca Raton, Florida. For more information visit www.firstwavebio.com.
About ImmunogenX,
Inc.
ImmunogenX, Inc. is a clinical-stage
biopharmaceutical company founded in 2013 and is supported by a team of world-renowned clinicians, scientists, and advisors in
celiac disease research. The company is developing latiglutenase (IMGX003) for celiac disease therapy. ImmunogenX is also developing
a diagnostic tool for celiac disease management (CypCelTM) as a minimally-invasive monitor of villus health to follow the
state of recovery of a celiac patient adhering to a gluten-free diet or other treatment. For more information visit
www.immunogenx.com.
About Tungsten Advisors
Tungsten Advisors (www.tungstenadv.com) is an
investment banking firm focused on strategic advisory and corporate finance for healthcare and technology companies. Tungsten provides
transactional services including financings (private placements/PIPEs), corporate licensing and mergers and acquisitions (M&A). Tungsten
also focuses on company incubation and makes direct investments alongside the creation of new companies in healthcare and technology.
Securities offered through Finalis Securities
LLC Member FINRA/SIPC. Tungsten Partners LLC d/b/a Tungsten Advisors and Finalis Securities LLC are separate, unaffiliated entities.
Forward-Looking Statements
This press release may contain certain statements
relating to future results which are forward-looking statements. It is possible that the Company’s actual results and financial
condition may differ, possibly materially, from the anticipated results and financial condition indicated in these forward-looking statements,
depending on factors including whether the transaction with ImmunogenX and any concurrent financing or licensing transaction may be completed
with different terms, in an untimely manner, or not at all; whether the Company will be able to realize the benefits of the proposed transactions
described herein; the Company’s ability to integrate the assets and commercial operations contemplated to be acquired from ImmunogenX
into the Company’s business; whether results obtained in preclinical and nonclinical studies and clinical trials will be indicative
of results obtained in future clinical trials; whether preliminary or interim results from a clinical trial will be indicative of the
final results of the trial; whether the Company will be able to maintain compliance with Nasdaq’s continued listing criteria and
the effect of a delisting from Nasdaq on the market for the Company’s securities; the size of the potential markets for the Company’s
drug candidates and its ability to service those markets; the effects of the First Wave Bio, Inc. acquisition, the related settlement
and their effect on the Company’s business, operating results and financial prospects; and the Company’s current and future
capital requirements and its ability to raise additional funds to satisfy its capital needs. Additional information concerning the Company
and its business, including a discussion of factors that could materially affect the Company’s financial results are contained in
the Company’s Annual Report on Form 10-K for the year ended December 31, 2022, under the heading “Risk Factors,” as
well as the Company’s subsequent filings with the Securities and Exchange Commission. All forward-looking statements included in
this press release are made only as of the date of this press release, and we do not undertake any obligation to publicly update or correct
any forward-looking statements to reflect events or circumstances that subsequently occur or of which we hereafter become aware.
For more information:
First Wave BioPharma, Inc.
777 Yamato Road, Suite 502
Boca Raton, FL 33431
Phone: (561) 589-7020
info@firstwavebio.com
Media contact:
Tiberend Strategic Advisors, Inc.
David Schemelia
(609) 468-9325
dschemelia@tiberend.com
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