First Wave BioPharma Names Brian Feagan, M.D., to Scientific Advisory Board

BOCA RATON, Fla., Dec. 09, 2021 (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 the appointment of Brian Feagan, M.D., Professor of Medicine, Epidemiology and Biostatistics at Western University and Senior Scientific Director, Alimentiv, Inc., to First Wave BioPharma's scientific advisory board (SAB), effective immediately.

Dr. Feagan will join Anthony Opipari, M.D., Ph.D.; Richard Marlink, M.D.; and Michael Konstan, M.D., on the First Wave BioPharma SAB. The SAB will work with management to guide and support First Wave BioPharma as it continues to advance its pipeline of development- and clinical-stage programs built around its two gut-restricted GI technologies – niclosamide, a small molecule with anti-viral and anti-inflammatory properties, and adrulipase, a recombinant lipase enzyme designed to help with the digestion of fats and other nutrients.

Dr. Feagan is a gastroenterologist with expertise in inflammatory bowel diseases (IBD) including ulcerative colitis and Crohn's disease. His research efforts focus on the design and implementation of randomized controlled trials of therapy for inflammatory bowel disease. He has been the principal investigator on more than 140 multi-center large-scale randomized clinical trials, focused on novel IBD therapeutics.

"We are excited to add a clinician and researcher of Dr. Feagan's caliber to the expanding group of scientific, medical and industry thought leaders providing First Wave BioPharma with expert counsel as we advance our multiple pipeline programs," said James Sapirstein, Chairman, President and CEO of First Wave BioPharma. "The appointment of Dr. Feagan reflects the expanded clinical development opportunities First Wave BioPharma is pursuing for its proprietary formulations of niclosamide in indications for inflammatory bowel diseases (IBDs). In particular, Dr. Feagan's experience treating inflammatory bowel disease and his research acumen should serve us well in the months and years to come as we advance our Phase 2 clinical trial of FW-UP in ulcerative proctitis and ulcerative proctosigmoiditis as a stepping stone to additional IBD indications, including ulcerative colitis and Crohn's disease."

First Wave BioPharma is developing therapies across six GI indications, including COVID-19-related GI infections, ulcerative proctitis (UP) and ulcerative proctosigmoiditis (UPS), Crohn's disease, ulcerative colitis, immune checkpoint inhibitor-associated colitis (ICI-AC), and exocrine pancreatic insufficiency (EPI) in patients with cystic fibrosis and chronic pancreatitis. Formulations of niclosamide are now the subject of two Phase 2 clinical trials. The first, initiated in June, is the Phase 2 RESERVOIR trial investigating an oral formulation of niclosamide, FW-COV, in patients with COVID-19-related GI infections. A second trial, initiated in October, is exploring a topical formulation of niclosamide, FW-UP, in patients with UP and UPS, two forms of ulcerative colitis, a chronic IBD, that affect the lower large intestine.

"I am excited for the opportunity to join First Wave BioPharma's SAB," said Dr. Feagan. "With its niclosamide formulations and adrulipase, the company has the potential to disrupt the GI space with a new wave of gut-targeted, non-systemic treatments for a host of diseases where there are significant unmet clinical needs and limited therapeutic options, resulting in painful, life-threatening and discomforting consequences for patients. I look forward to working with the entire SAB to advance the development of better treatment options that will help protect the health and restore the quality of life for millions of patients."

About Dr. Brian Feagan

Dr. Feagan is a gastroenterologist, with training in Clinical Epidemiology and Biostatistics, now serving as Professor of Medicine, Epidemiology and Biostatistics at Western University and Senior Scientific Director at Alimentiv, Inc. He earned his medical degree at the University of Western Ontario (UWO) in London, Ontario, Canada. His postdoctoral training included a residency in Internal Medicine and a clinical fellowship in Gastroenterology in the Department of Medicine at UWO, and postgraduate training in the Department of Epidemiology and Biostatistics at McMaster University, Hamilton, Ontario. A Fellow of the Royal College of Physicians and Surgeons of Canada, Dr. Feagan holds membership in the Canadian and American Association of Gastroenterology, the American College of Gastroenterology, the College of Physicians and Surgeons of Ontario, Crohn's and Colitis Canada (CCC) and European Crohn's and Colitis Organization (ECCO). He has authored over 480 articles and book chapters and has given over 600 invited presentations at national and international scientific meetings. In 1997, Dr. Feagan was named Director of Robarts Clinical Trials at the Robarts Research Institute, University of Western Ontario and in 2020, he became Senior Scientific Director of Alimentiv, Inc. (formerly Robarts Clinical Trials). His research efforts focus on the design and implementation of randomized controlled trials of therapy for inflammatory bowel disease. He has been the principal investigator on numerous large-scale randomized clinical trials.

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. First Wave BioPharma is currently advancing a therapeutic development pipeline populated with multiple clinical stage programs built around its two proprietary technologies – niclosamide, an oral small molecule with anti-viral and anti-inflammatory properties, and the biologic adrulipase, a recombinant lipase enzyme designed to enable the digestion of fats and other nutrients. The Company's niclosamide portfolio is led by two clinical programs in Phase 2 clinical trials: FW-COV, for COVID-19 gastrointestinal infections and FW-UP, for ulcerative proctitis (UP) and ulcerative proctosigmoiditis. Three additional indications of niclosamide, FW-ICI-AC, for Grade 1 and Grade 2 Immune Checkpoint Inhibitor-associated colitis and diarrhea in advanced oncology patients, FW-UC (ulcerative colitis) and FW-CD (Crohn's disease) are expected to enter the clinic in 2022 and 2023. First Wave BioPharma is also advancing FW-EPI (adrulipase) for the treatment of exocrine pancreatic insufficiency (EPI) in patients with cystic fibrosis and chronic pancreatitis. The Company 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; 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 and its announcement on the Company's business, operating results and financial prospects; the integration of the First Wave Bio, Inc. business with the Company's own business; 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, 2020 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

[email protected]

Media contact:

Tiberend Strategic Advisors, Inc.

Johanna Bennett / David Schemelia

(212) 375-2665 / (609) 468-9325

[email protected] / [email protected]