First Wave BioPharma Chairman and CEO Issues Letter to Stockholders

Rhea-AI Summary

First Wave BioPharma (FWBI) announced plans to file an Investigational New Drug application with the FDA to evaluate an enhanced enteric microgranule formulation of adrulipase for treating exocrine pancreatic insufficiency related to cystic fibrosis and chronic pancreatitis. The company aims to initiate a Phase 2 trial by year-end 2022, with results expected in mid-2023. Significant cost-cutting measures have been implemented, including eliminating $10 million in fixed liabilities and a recent stock offering of $6 million. The company expresses optimism about adrulipase's potential to reduce pill burden for patients.

Positive

• IND application filing with the FDA for adrulipase expected.
• Initiation of Phase 2 clinical trial anticipated by year-end 2022.
• Cost-cutting measures successfully eliminated $10 million in liabilities.
• Raised $6 million through recent stock and warrant offering.

Negative

• Need to raise additional capital by November 22, 2022, to support operations.

BOCA RATON, Fla., Nov. 16, 2022 (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 expect to file an Investigational New Drug (IND) application with U.S. Food and Drug Administration (FDA) to evaluate an enhanced enteric microgranule delivery formulation of adrulipase as a potential treatment for exocrine pancreatic insufficiency (EPI) associated with cystic fibrosis (CF) and chronic pancreatitis (CP) in human clinical trials. Once we receive FDA clearance of our IND, First Wave expects to initiate a Phase 2 clinical trial prior to year-end 2022 with top-line data anticipated by the end of the first half of 2023.

Adrulipase is our most clinically advanced asset, and we believe our enhanced formulation offers the potential to be a best-in-class treatment for EPI associated with CF and CP. 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.

During 2022, we have implemented significant cost-cutting measures to conserve cash to support clinical development of adrulipase. We also restructured our obligations to the former stockholders of First Wave Bio, Inc. which eliminated $10 million of fixed liabilities from our balance sheet. Pursuant to our plan to regain and maintain compliance with Nasdaq’s continued listing requirements, we completed a reverse stock split of our common stock in late August and have raised a significant amount of new capital since June 30, 2022, including a $6 million stock and warrant offering in October. We intend to raise additional capital, subject to market conditions, to complete our compliance plan by the November 22, 2022 deadline and to support our business.

We remain dedicated to fulfilling our mission to help alleviate the suffering of patients with gastrointestinal (GI) disease, especially those with EPI. We attended the most recent North American Cystic Fibrosis Conference (NACFC) in Philadelphia and met with clinicians, KOLs and patient advocates. In our discussions, they have expressed a strong desire for adrulipase given the many challenges presented by the current standard of care, pancreatic enzyme replacement therapy (PERT). The pill burden for current commercial PERT medications can be as high as 40 capsules per day, creating a substantial challenge for EPI patients. We believe that our adrulipase formulation will reduce the number of pills required to maintain effectiveness which will be a key differentiator for patients.

I want to thank everyone again for investing in and supporting our Company. Despite the current market conditions, we remain very optimistic about the prospects for adrulipase and look forward to initiating our next Phase 2 clinical trial.

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 regain and maintain compliance with Nasdaq’s continued listing criteria; 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.
Bill Borden
(732) 910-1620
bborden@tiberend.com

Dave Schemelia
(609) 468-9325
dschemelia@tiberend.com

FAQ

What is First Wave BioPharma's plan for adrulipase?

First Wave BioPharma plans to file an IND application for adrulipase to treat exocrine pancreatic insufficiency and aims to start a Phase 2 clinical trial by the end of 2022.

When does First Wave BioPharma expect to release Phase 2 trial data?

Top-line data from the Phase 2 trial of adrulipase is expected by the end of the first half of 2023.

What significant financial actions has First Wave BioPharma taken recently?

The company eliminated $10 million in liabilities and raised $6 million through a stock and warrant offering.

Why is First Wave BioPharma optimistic about adrulipase?

The company believes adrulipase could be a best-in-class treatment due to its enhanced formulation, which may offer improved efficacy with fewer pills for patients.

What challenges does First Wave BioPharma face regarding compliance?

The company must raise additional capital by November 22, 2022, to maintain Nasdaq compliance.