First Wave BioPharma (FWBI) CEO Issues Letter to Stockholders, Provides 2024 Outlook

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 James Sapirstein, Chairman and CEO of First Wave BioPharma, has issued a Letter to Stockholders highlighting the Company’s recent accomplishments and plans for 2024. The full text of the letter follows.

A MESSAGE FROM OUR CHAIRMAN AND CHIEF EXECUTIVE OFFICER

To my fellow stockholders,

Strong Strategic Rationale and Operational Fit for Anticipated Business Combination with ImmunogenX

The close of 2023 has been an exciting period for First Wave BioPharma, highlighted by the recently announced potential business combination with ImmunogenX. We recently announced a non-binding term sheet with ImmunogenX and are currently in negotiations for a definitive agreement. In the event this potential transaction is completed, we will gain access to Phase 3-ready latiglutenase, a potentially first-in-class, targeted, oral biotherapeutic for celiac disease, and a team of visionary scientists led by Jack Syage, Ph.D., who is expected to become our President and Chief Operating Officer, and Professor Chaitan Khosla, who completed the seminal work leading to the discovery of latiglutenase at Stanford University.

Any definitive agreement with respect to the potential transaction and completion of the transaction would be subject to approval by the respective parties to that definitive agreement, including approval by our board of directors and/or stockholders, approval by ImmunogenX’s stockholders, various regulatory approvals, and the combined company having sufficient capital to carry out the planned businesses.

Concurrent Strategic Pharma Commercial Agreement and Institutional Investment Anticipated in 1H’24

Additionally, in the event the Company closes the potential ImmunogenX transaction, we would expect to concurrently announce a significant non-dilutive financial investment from a strategic global pharmaceutical company for commercial rights to latiglutenase in the United States and Canada, as well as financing commitments from several institutional investors to fund the drug’s development. These expected investments are based on the potential of latiglutenase 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.

Latiglutenase: A Phase 3 Ready Asset for Celiac Disease Addressing a Major Unmet Clinical Need

The Phase 3 clinical development plan for latiglutenase has been reviewed by the GI Division of the U.S. Food and Drug Administration (FDA), with initiation of the Phase 3 trials expected in the second half of 2024. This timing could enable latiglutenase to enter the multibillion-dollar celiac disease market by 2027.

In the event the Company closes the potential transaction with ImmunogenX, First Wave BioPharma could become a Phase 3 company with a drug technology that, upon successful completion of the trials and approval by the FDA, could be first-to-market for a GI disease that impacts millions of people and where no approved therapy exists.

We believe this possibility, on its own, offers the potential to substantially enhance the value of First Wave BioPharma for our stockholders given the numerous development and regulatory milestones expected with the latiglutenase program in 2024 and beyond, in the event the Company closes the potential transaction with ImmunogenX. But it is not the only substantial growth opportunity for our company.

Capeserod: A Phase 2 Asset Licensed from Sanofi with Applications in Multi-Billion Dollar GI Indications

Prior to our discussions with ImmunogenX, we strengthened our GI-focused pipeline with the addition of capeserod, a selective 5-HT4 receptor partial agonist, from Sanofi. Artificial intelligence (AI)-empowered analyses indicate the drug’s prokinetic mechanism of action has potential applications for several gastrointestinal disorders in multibillion-dollar markets, such as gastroparesis, where there are significant unmet clinical needs and no commercially available therapies without serious side effects. Based on these analyses and buoyed by capeserod’s strong safety profile, we are moving rapidly to initiate Phase 2 clinical trials in 2024 and will be liaising with the FDA to establish the best developmental and regulatory pathway forward.

Niclosamide: Streamlining Our Clinical Pipeline

In late December, we announced the signing of a non-binding term sheet to sell our niclosamide inflammatory bowel disease (IBD) program to an undisclosed biopharmaceutical company. The non-binding term sheet includes a low seven-figure payment to First Wave BioPharma along with economics related to future milestones and royalties.

We believe niclosamide has potential as a non-steroidal anti-inflammatory therapy for the treatment of mild-to-moderate IBDs. However, we made the strategic decision to streamline our development pipeline following the in-licensing of Phase 2-ready capeserod from Sanofi and the pending addition of Phase 3-ready latiglutenase. If completed, we believe this transaction would allow us to focus our development efforts on those assets, while providing the potential to infuse our company with additional, non-dilutive capital.

First Wave BioPharma: A Diversified Late-Stage Clinical Portfolio with Three GI Assets

In the event the Company closes the potential transaction with ImmunogenX, latiglutenase and capeserod will headline a late-stage GI pipeline that is unrivaled by other companies of similar size to First Wave. Add to that, ongoing analyses of the adrulipase Phase 2 data have been promising and suggest potential opportunities to advance the program. We plan to request a meeting with the FDA in Q1’2024 to discuss the data and a clinical development plan given the shortcomings with current treatments for exocrine pancreatic insufficiency in patients with cystic fibrosis and chronic pancreatitis.

For our stockholders…

This is a very exciting time in the growth and evolution of First Wave BioPharma, and we are working diligently to advance our multiple, late-stage development programs to bring relief to patients living daily with the often painful, dangerous and discomforting symptoms inherent to gastrointestinal disease.

2024 has the potential to be a year of significant growth for First Wave BioPharma, and once again, I thank all of our stockholders for your continued support.

Sincerely,
James Sapirstein
Chairman and CEO
First Wave BioPharma, Inc.

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