First Wave BioPharma Chairman and CEO Issues Letter to Stockholders

Rhea-AI Summary

First Wave BioPharma (FWBI) announced significant updates regarding its clinical programs, specifically the adrulipase formulation for treating exocrine pancreatic insufficiency (EPI). The company plans to submit an IND application to the FDA for a Phase 2 study of the enhanced formulation, expected to start by year-end 2022. This new formulation aims to improve therapeutic efficacy and reduce pill burden for patients. Additionally, First Wave has improved its balance sheet by eliminating $10 million in liabilities and has completed funding through an at-the-market sales program.

Positive

• New adrulipase formulation shows improved efficacy in in vitro testing.
• Planned IND submission for Phase 2 study may enhance market position.
• Reduced patient pill burden could differentiate the product.
• Eliminated approximately $10 million in fixed liabilities, improving balance sheet.
• Successfully raised capital through at-the-market sales program.

Negative

• Mixed results from previous niclosamide trials may hinder future development.
• Potential market risks and uncertainties remain as biotech sector faces challenges.

BOCA RATON, Fla., Sept. 19, 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 First Wave BioPharma, has issued a Letter to Stockholders to provide 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 are excited by the news announced last week concerning adrulipase, our product candidate for the treatment of exocrine pancreatic insufficiency (EPI) associated with cystic fibrosis (CF) and chronic pancreatitis (CP). As we announced, after extensive research by First Wave BioPharma and our drug delivery formulation partner, we believe we have identified an enhanced enteric microgranule drug delivery formulation of adrulipase for use in the continued development of our clinical program (FW-EPI). We intend to submit an Investigational New Drug (IND) application to the U.S. Food & Drug Administration (FDA) for a Phase 2 “proof-of-concept” clinical study investigating the improved formulation of adrulipase as a potential treatment for EPI. We anticipate that this trial will commence prior to year-end 2022, subject to FDA’s acceptance of the IND.

We believe the new formulation will allow us to reignite our adrulipase development program. For those new to First Wave BioPharma, adrulipase is our most clinically advanced asset and we believe it offers the potential to be a best-in-class treatment for EPI associated with CF and CP. The cumulative data generated in our earlier clinical trials of adrulipase demonstrated an excellent safety profile and a mechanism of action that we believe should enable a therapeutic benefit. However, as previously reported, the prior formulation resulted in an inconsistent dispersal of adrulipase in the gastrointestinal tract which resulted in it not achieving its efficacy endpoints.

In our in vitro testing, the new enteric microgranule drug delivery formulation of adrulipase outperformed prior versions of the drug while enabling us to make significant improvements in manufacturing yields and lowering our costs. The in vitro data suggest the new formulation has a delayed-release profile that should protect adrulipase in the stomach and enable it to be delivered to the targeted areas of the GI tract where it can mix with food in the duodenum to provide its therapeutic effect. 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.

Additionally, our research indicates that 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 associated with pancreatic enzyme replacement therapy (PERT) can be as high as 40 capsules per day, creating a substantial challenge for EPI patients. We believe that a reduction in the number of pills required to maintain effectiveness will be a key differentiator for patients. Moreover, we have identified manufacturing improvements that we believe have the potential to lower the cost of goods by significantly increasing production yields.   We are excited to present the research relating to this improved adrulipase formulation at AAPS 2022 PharmSci 360 in Boston next month.

Given these important advances with adrulipase, we have made the strategic decision to direct our near-term resources towards the filing of the IND and the Phase 2 clinical trial of the new adrulipase formulation. As a result, we will be devoting fewer resources to our niclosamide programs following the mixed results from the COVID-19 trial (FW-COV) and inconclusive data from a small Phase 2 trial of niclosamide in ulcerative proctitis (UP) and ulcerative proctosigmoiditis (UPS).

We have also taken significant steps to improve our balance sheet, including settling the lawsuit filed against us by the former stockholders of First Wave Bio, Inc. on terms that included a significant restructuring of our obligations to them. The restructuring resulted in the elimination of approximately $10 million of fixed liabilities from our balance sheet. In compliance with our plan to regain and maintain compliance with Nasdaq’s continued listing requirements, we effected a reverse stock split of our common stock in late August and have raised a significant amount of new capital since June 30, 2022, primarily through our at-the-market sales program, which is now complete. As part of our Nasdaq compliance plan, we hope to raise additional capital, subject to market conditions, to meet Nasdaq’s continuing listing standards and to support our business.

As many of our stockholders are painfully aware, the first nine months of 2022 have been a difficult time for biotechnology stocks of all sizes. Despite the challenges we have faced, the Company has made significant strides in its clinical development efforts and substantially improved its balance sheet and capital position. We are excited for the future.

In closing, we remain committed to bring relief to patients living with the often painful, dangerous and discomforting symptoms tied with GI disease, to protect their health and to restore quality of life.

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 contemplated offering will be successful and 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 the latest update from First Wave BioPharma regarding adrulipase?

First Wave BioPharma announced an enhanced formulation of adrulipase for treating EPI, with plans to submit an IND application for a Phase 2 study by year-end 2022.

How does the new adrulipase formulation improve treatment for patients?

The new formulation aims to increase effectiveness while reducing the number of pills patients need to take, addressing the high pill burden associated with current therapies.

What financial improvements has First Wave BioPharma made recently?

The company eliminated approximately $10 million in fixed liabilities and raised capital through an at-the-market sales program, improving its financial stability.

When will the Phase 2 trial for the new adrulipase formulation begin?

The Phase 2 trial for the new adrulipase formulation is expected to commence prior to the end of 2022, pending FDA approval of the IND application.

What challenges does First Wave BioPharma face in its clinical development?

The company faces challenges related to mixed results from previous niclosamide trials and the overall tough market conditions for biotechnology stocks.