Full Press Release Details
First Wave BioPharma Announces Completion of
Business Combination with ImmunogenX, Adding Phase 3-Ready Latiglutenase to its Late-Stage GI-Focused Clinical Pipeline
Latiglutenase is a potentially first-in-class
oral biotherapeutic for the treatment of celiac disease
James Sapirstein, Chairman and Chief Executive
Officer, to continue leading First Wave BioPharma; Jack Syage, Ph.D., named President and Chief Operating Officer
A strategic U.S. commercial license agreement
with a global pharmaceutical company and concurrent institutional investment expected to close in 2H'24
Conference Call Scheduled for Today at 8:30
BOCA RATON, FL., March 14, 2024 - 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 it has
acquired 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, a potentially first-in-class, near Phase 3-ready, targeted, oral biotherapeutic for celiac disease.
James Sapirstein will continue to serve as Chairman and Chief Executive Officer of First Wave BioPharma with Jack Syage, Ph.D., previously
the Chief Executive Officer and Co-Founder of ImmunogenX, assuming the role of President and Chief Operating Officer of First Wave BioPharma.
Dr. Syage and Dr. Chaitan Khosla will also join the board of directors of First Wave BioPharma.
First Wave BioPharma intends to license the commercial
rights to latiglutenase in the United States and Canada to a strategic global pharmaceutical company which will commercialize latiglutenase
following receipt of marketing approval. First Wave BioPharma will also seek to secure financing commitments from a syndicate of institutional
healthcare investors to fund the ongoing development of latiglutenase. The closing of a strategic licensing agreement and any other financings
would be contingent upon the satisfaction of a number of conditions, including customary due diligence, the negotiation and execution
of definitive agreements, Board approval and receipt of all required third-party (including governmental) approvals, licenses, consents,
and clearances, as and when applicable.
Latiglutenase, an oral biotherapeutic composed
of two gluten-specific recombinant proteases, has demonstrated effectiveness in reducing intestinal damage and alleviating symptoms of
celiac disease in two Phase 2 trials involving approximately 200 patients. The Phase 3 clinical plan for latiglutenase has been reviewed
by the GI Division of the U.S. Food and Drug Administration (FDA) and the trials are anticipated to begin in early 2025.
"Completion of the acquisition of ImmunogenX
and the addition of latiglutenase to our clinical pipeline is a transformative event for First Wave BioPharma as it provides our company
with a Phase 3-ready asset in a multibillion-dollar GI market - celiac disease - for which no approved pharmacologic treatment
currently exists," stated Mr. Sapirstein. "Given this enormous potential, we are working with Dr. Syage and his team to advance
the regulatory, manufacturing, and clinical processes that would enable the initiation of the pivotal Phase 3 clinical trials of latiglutenase
in 2025. To that end, we will seek to develop latiglutenase by completing an agreement with a global pharmaceutical company to provide
First Wave with non-dilutive financing in exchange for U.S. and Canadian rights to the drug and to obtain financing with a syndicate of
leading institutional healthcare funds in 2H'24. We expect to finalize these agreements prior to initiating preparatory work for
the Phase 3 latiglutenase trials."
Dr. Syage commented: "I am excited to join
First Wave BioPharma and advance the company's mission to become a leading developer of targeted, orally delivered therapeutics
for GI diseases. We believe latiglutenase has the potential to transform the treatment of celiac disease with data from two prior Phase
2 trials indicating the therapy is well tolerated and effective in degrading the key gluten proteins responsible for intestinal damage
and celiac disease symptoms. This merger with First Wave will provide the support needed to propel the development of latiglutenase, a
program that has already received significant NIH grant funding and encouragement from the FDA."
Mr. Sapirstein concluded: "First Wave BioPharma
now possesses a GI-development pipeline unrivaled by other companies of similar size. In addition to latiglutenase, our product portfolio
includes capeserod, a selective 5-HT4 receptor partial agonist in-licensed from Sanofi, which is being developed for an anticipated Phase
2 trial in gastroparesis, and Phase 2-ready adrulipase, a recombinant lipase designed to enable the digestion of fats and improve nutritional
health in cystic fibrosis patients with exocrine pancreatic insufficiency."
Upon closing of the acquisition, the Company issued
365,162 shares of its common stock to the shareholders (including option and warrant holders) of ImmunogenX equal to 19.02% of its currently
issued and outstanding common stock and 11,777.418 shares of its newly issued Series G Convertible Preferred Stock (with a conversion
ratio of Preferred to Common at 1:1000) representing on a fully diluted basis 81.9% for ImmunogenX and 18.1% for First Wave Biopharma
(excluding transaction fees) with a combined fully diluted equity value of $104 million. The shares of the Company's common stock
issuable upon conversion of the Series G Preferred Stock shall be subject to stockholder approval in compliance with the rules of the
Nasdaq Stock Market.
Tungsten Advisors served as the exclusive financial
advisor to First Wave BioPharma.
Conference Call Information:
BioPharma will host a conference call and live audio webcast today, March 14, 2024, at 8:30 a.m. ET, to discuss the definitive merger
agreement with ImmunogenX and provide a strategic outlook for company.
The audio webcast of the conference call will be accessible
via the Investors section of the First Wave website: https://www.firstwavebio.com/investors/overview and from the following
An archive of the webcast will remain available for 90 days
beginning at approximately 10:30 a.m. ET, on March 14, 2024.
Additionally, interested participants and investors may access
the conference call telephonically by registering via the following online form:
Once registered, all individuals will be provided with a
participant dial-in number, a passcode, and a registrant ID, which can then be used to access the conference call.
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 2025.
About Celiac Disease
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.
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 -
latiglutenase, a Phase 3-ready, potentially first-in-class, targeted, oral biotherapeutic for celiac disease; capeserod, a selective
5-HT4 receptor partial agonist being developed for gastroparesis; and 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. First
Wave BioPharma is headquartered in Boca Raton, Florida. For more information visit www.firstwavebio.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
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