First Wave BioPharma Chairman and CEO Issues Letter to Stockholders

BOCA RATON, Fla., Feb. 13, 2023 (GLOBE NEWSWIRE) — 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, President and CEO of First Wave BioPharma, has issued a Letter to Stockholders providing an update on the Company’s clinical programs and recent events. The full text of the letter follows.

A MESSAGE FROM OUR CHAIRMAN AND CHIEF EXECUTIVE OFFICER

To my fellow stockholders,

We look forward to 2023 after a challenging 2022 when small biotechnology companies endured one of their worst years on record. First Wave BioPharma was not immune to this unfortunate trend, but we weathered the storm. We look forward to capitalizing on several growth drivers in 2023 and reaching our next clinical milestone.

Phase 2 Adrulipase Trial Initiated, Topline Data Expected in Mid-2023

Key to our value proposition is the advancement of our adrulipase program. We are excited to have initiated our Phase 2 clinical trial investigating a new enteric microgranule formulation of adrulipase as a potential treatment for exocrine pancreatic insufficiency (EPI) associated with cystic fibrosis (CF) and chronic pancreatitis (CP). Patients are now being screened at three clinical trial sites with dosing expected to begin by mid-February. This timeline should enable us to announce topline results sometime in mid-2023.

Trial to Test Efficacy of New Enteric Formulation

The Phase 2 multi-center study is designed to investigate the safety, tolerability and efficacy of our enhanced formulation of adrulipase in a titrated dose-escalation study involving an estimated twelve patients. The primary efficacy endpoint is the coefficient of fat absorption (CFA), with secondary endpoints of stool weight, signs and symptoms of malabsorption, and coefficient of nitrogen absorption (CNA).

We believe our enhanced formulation of adrulipase has the potential to be a best-in-class treatment for EPI associated with CF and CP. Our recombinant lipase is non-animal derived and a potential alternative monotherapy to commercial porcine pancreatic enzyme replacement therapy (PERT).    First Wave spent much of the past year reformulating adrulipase, improving manufacturing yields, and reducing the cost of goods to make adrulipase more price-competitive with commercial PERT.

As disclosed previously, in vitro data suggest the microgranule drug delivery formulation offers improved protection against the acidic pH in the stomach followed by the rapid release of adrulipase in the small intestine where the drug is expected to mix with food and deliver its therapeutic benefit.   Based on our in vitro testing, we expect that the new formulation of adrulipase will result in consistent coefficient of fat absorption (CFA) values greater than 80%. CFA greater than 80% is the recognized threshold for achieving therapeutic benefit in patients with EPI associated with CF and CP.  

Moreover, in vitro research indicates the enhanced formulation has the potential to significantly decrease the number of pills a patient would need to take to achieve the desired therapeutic effect. The pill burden for current commercial porcine PERT can be as high as 40 capsules per day, creating a substantial challenge for EPI patients. We believe that with adrulipase we can reduce the pill burden to 5-8 capsules per day.

A Potential Game-Changer in a $2.2 Billion Global Market

We are eager to test our new formulation of adrulipase in the Phase 2 clinical trial in what we hope is a springboard to advancing adrulipase through a pivotal Phase 3 clinical trial, towards a Biologics License Application (BLA), and then potential future commercialization. Our ultimate goal is to provide those suffering from EPI with a therapeutic option that better addresses the numerous, debilitating symptoms they experience on a daily basis and improves their nutritional health and quality of life. If successful, we believe adrulipase has the potential to supplant porcine PERT as the standard of care for EPI associated with CF and CP in an estimated $2.2 billion global market.

We recently filed a U.S. Provisional Patent application involving the composition of matter improvements designed to enhance adrulipase’s delayed release profile.   The filing adds to the growing intellectual property portfolio governing adrulipase, which includes patent applications for adrulipase formulation and methods of use and the utilization of enteric formulations in the delivery of adrulipase.   Our IP protection extends into the 2042-2043 timeframe.
        
Company Regains Nasdaq Compliance, Enabling Ability to Access Public Markets

In parallel with the clinical, regulatory and IP activities for adrulipase, First Wave has now completed a lengthy, multi-step process to maintain our listing on the Nasdaq Capital Market. Now that we are out of the hearing panel oversight process and in compliance with Nasdaq’s continued listing requirements, we believe we will have the access to public markets to capitalize on the many growth drivers we foresee for 2023 and beyond, which we believe will result in increased value for our stockholders.

Focused on Completion of Adrulipase Phase 2 Trial in 2023

In closing, the past twelve months have been a difficult time for us and biotechnology stocks of all sizes. We have survived those challenges. The Company has significantly reduced its operational spend and headcount and is focused on the successful completion of our Phase 2 trial, a potential value-building event.

We continue our mission to bring relief to patients living with the often painful, dangerous and discomforting symptoms tied to GI disease, to protect their health and to restore their quality of life.

Once again, I thank all of our stockholders for their patience and continued support.

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

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 clinical stage programs built around its two proprietary technologies – the biologic adrulipase, a recombinant lipase enzyme designed to enable the digestion of fats and other nutrients, and niclosamide, an oral small molecule with anti-inflammatory properties. First Wave is advancing two Phase 2 clinical programs built around adrulipase for the treatment of exocrine pancreatic insufficiency (FW-EPI) in patients with cystic fibrosis (CF) and chronic pancreatitis (CP). In developing adrulipase, First Wave is seeking to provide CF and CP patients with a safe and effective therapy to control EPI that is non-animal derived and offers the potential to dramatically reduce their daily pill burden. The company is also advancing multiple programs involving niclosamide, including FW-UP for ulcerative proctitis and ulcerative proctosigmoiditis, FW-UC for ulcerative colitis, and FW-CD for Crohn’s disease. First Wave BioPharma is headquartered in Boca Raton, Florida. For more information visit www.firstwavebio.com.

Forward-Looking Statement
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 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, 2021 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

Bill Borden
(732) 910-1620
bborden@tiberend.com