First Wave BioPharma Announces Two Additions to Scientific Advisory Board

Globally Recognized Experts in Gastrointestinal Diseases, Cystic Fibrosis and Virology to Support Company in Advancing Niclosamide and Adrulipase Clinical Programs

BOCA RATON, Fla., Oct. 12, 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 additions to the Company’s Scientific Advisory Board (SAB) to reflect the expanded clinical development opportunities into COVID-19-related gastrointestinal infections, immune checkpoint-associated colitis (ICI-AC), and inflammatory bowel diseases (IBD) following its recent acquisition of First Wave Bio, Inc. (“First Wave Bio”).

Effective immediately, Anthony Opipari, M.D., Ph.D., a co-founder and the former Chief Medical Officer of First Wave Bio and Richard Marlink, M.D., Director of the Rutgers Global Health Institute, will join Michael Konstan, M.D., the Vice Dean for Translational Research and the Gertrude Lee Chandler Tucker Professor of Pediatrics at Case Western Reserve University School of Medicine, as members of First Wave BioPharma’s SAB. In connection with these appointments, it is anticipated that two existing members of the SAB, Darwin L. Conwell, M.D. and Michael Wilschanski, M.D., will transition onto an adrulipase steering committee for exocrine pancreatic insufficiency for cystic fibrosis and chronic pancreatitis.

The SAB will work with management to guide and support First Wave BioPharma, as it continues to advance its pipeline of clinical-stage programs built around two gut restricted GI technologies – niclosamide, a small molecule with anti-viral and anti-inflammatory properties, and adrulipase, a recombinant lipase enzyme biologic designed to enable the digestion of fats and other nutrients in patients with exocrine pancreatic insufficiency.

“We are excited to have added prestigious scientific, medical and industry thought leaders to provide First Wave BioPharma with expert counsel as we advance our multiple pipeline programs,” said James Sapirstein, Chairman, President and CEO of First Wave BioPharma. “Each member of our SAB brings his own unique expertise, be it research into treatment for cystic fibrosis, autoimmune and inflammatory bowel diseases, or decades of work establishing large-scale AIDS and HIV antiviral research and treatment programs in the U.S. and Africa. This collection of keen minds, and their collective expertise, should serve us well in the months and years to come.”

With its acquisition of First Wave Bio, announced on September 13, 2021, First Wave BioPharma is developing therapies across six GI indications, including Crohn’s disease, ulcerative colitis, ulcerative proctitis and ulcerative proctosigmoiditis, COVID-19-related GI infections, immune checkpoint inhibitor-associated colitis (ICI-AC) and exocrine pancreatic insufficiency (EPI) in patients with cystic fibrosis and chronic pancreatitis. First Wave BioPharma now wholly owns all rights to First Wave Bio’s proprietary formulations of niclosamide and a robust patent IP portfolio covering methods of use for all inflammatory bowel disease (IBD) indications as well as ICI-AC and COVID-related GI infections.

“I am delighted to join First Wave BioPharma’s SAB along with my esteemed colleagues,” said Dr. Opipari. “With its niclosamide products and adrulipase, the company has the potential to disrupt multiple therapeutic areas in the GI space with a new wave of targeted, non-systemic treatments for Crohn’s disease and other IBDs, as well as serious digestive complications and nutritional disorders facing cystic fibrosis and cancer patients. I look forward to working with this team toward the common goal of improving treatment options and restoring the quality of life for millions of patients.”

About the Scientific Advisory Board

Dr. Anthony Opipari is a physician scientist known for his recent work at the interface between clinical medicine, basic research, and drug development. He co-founded the former First Wave Bio and served as the company’s Chief Medical Officer until its acquisition by AzurRx BioPharma (now First Wave BioPharma). Previously, Dr. Opipari was a member of the faculty of the University of Michigan Medical School, in the Division of Gynecological Oncology, until he retired from active faculty and was awarded emeritus status in 2019. His NIH-funded research at the University of Michigan resulted in the discovery of novel drug targets and associated novel therapeutic mechanisms of action that formed the basis for multiple biotechnology spinouts, including Lycera Corp., which he co-founded. Dr. Opipari also co-founded and directed translational medicine at IFM Therapeutics, a privately held biopharmaceutical company focused on developing therapies that modulate novel targets in the innate immune system to treat inflammatory diseases and cancer. Dr. Opipari earned a medical degree and a Ph.D. in Cellular and Molecular Biology from the University of Michigan.

Dr. Richard Marlink has served at Rutgers University in New Brunswick, NJ since 2016 as the Director of the Rutgers Global Health Institute and the Henry Rutgers Professor of Global Health. A medical oncologist by training, he has extensive experience in epidemic response and capacity building, having worked to establish large-scale HIV/AIDS research, training, and clinical care programs in the U.S. and abroad. This work included establishing the first AIDS clinic in Boston, serving as the principal investigator for “The Tshepo Study,” the first large-scale antiretroviral treatment study in southern Africa, and serving as Scientific Director and Vice President for Implementation at the Elizabeth Glaser Pediatric AIDS Foundation. More recently, Dr. Marlink’s work in NJ has focused on the COVID-19 pandemic. He serves on the Newark Reopening and Recovery Strikeforce and helped develop the city’s initial COVID-19 testing plan, while also spearheading an initiative to support the safe reopening of small businesses in low-income and minority communities and to better prepare those communities for future public health threats. Dr. Marlink has authored or co-authored 147 peer-reviewed articles, numerous scientific articles and chapters, and the textbook, Global AIDS Crisis: A Reference Handbook. He also co-edited the book, AIDS in Africa, served as chief editor for two special supplements to the journal AIDS and served as executive editor of the 320-author, three-volume textbook, From the Ground Up: Building Comprehensive HIV/AIDS Care Programs in Resource Limited Settings. Dr. Marlink completed a hematology/oncology fellowship at the Beth Israel Deaconess Medical Center at Harvard Medical School. He received his medical degree from the University of New Mexico and received his bachelor’s degree from Brown University.

Dr. Michael Konstan is Vice Dean for Translational Research and the Gertrude Lee Chandler Tucker Professor of Pediatrics at Case Western Reserve University School of Medicine, and the Austin Ricci Chair in Pediatric Pulmonary Care and Research at University Hospitals Rainbow Babies and Children’s Hospital in Cleveland, Ohio. He was appointed to the Scientific Advisory Board for the former AzurRx BioPharma (now First Wave BioPharma) in October 2020 in recognition of an extensive career researching and caring for patients with cystic fibrosis (CF). Having led several national and international clinical trials exploring potential new CF treatments, Dr. Konstan’s seminal work in the field led to several current therapies, including the only treatment using high-dose ibuprofen currently recommended for lung inflammation in CF patients. Dr. Konstan was the first recipient of the Cystic Fibrosis Foundation’s Harry Shwachman Clinical Investigator Award, and later received the foundation’s Richard C. Talamo Distinguished Clinical Achievement Award. He has published extensively in medical literature with more than 200 peer-reviewed articles, nearly all related to cystic fibrosis. Dr. Konstan has served on multiple advisory boards and committees for the Cystic Fibrosis Foundation, the National Institutes of Health (NIH) and the U.S. Food and Drug Administration (FDA), all related to advancing the treatment of CF patients. He currently serves on the Cystic Fibrosis Foundation’s Clinical Research Executive Committee. Dr. Konstan earned his bachelor’s and medical degrees from Case Western Reserve University (CWRU).

About First Wave BioPharma, Inc.
First Wave BioPharma, Inc. 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. First Wave BioPharma’s niclosamide portfolio is led by three clinical programs: FW-COV, for COVID-19 gastrointestinal infections; FW-UP, for ulcerative proctitis (UP) and ulcerative proctosigmoiditis; and FW-ICI-AC, for Grade 1 and Grade 2 Immune Checkpoint Inhibitor-associated colitis and diarrhea in advanced oncology patients. Two additional formulations of niclosamide, FW-UC (ulcerative colitis) and FW-CD (Crohn’s disease) are expected to enter the clinic in 2022 and 2023, respectively. 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 with clinical operations in Hayward, California. 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
info@firstwavebio.com

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