First Wave BioPharma, Inc.

President and CEO James Sapirstein has 38 years of pharmaceutical experience, having held positions at Eli Lilly, Hoffman-Laroche, Bristol Myers Squibb, and Gilead. He led the Global Marketing Team while at Gilead and was instrumental in in the global marketing strategy for Viread (tenofovir), their flagship HIV drugs. He also played a key role in bringing to market Truvada, Gilead's multi-billion dollar blockbuster HIV drug. Sapirstein also helped found Tobira Therapeutics, which was later purchased by Allergan. All in all, Mr. Sapirstein has participated in over 25 drug launches.

He was also Chairman of the Board for BioNJ, an association of biopharma industries in New Jersey from Feb 2017-Feb 2019. In addition, he is a Board Director for BIO, the leading Biopharma Industries Organization promoting public policy and networking in the healthcare space, where he sits on the Emerging Companies Section Governing Board.

Additionally, with a Scientific Advisory Board and several Clinical Steering Committees steeped in experience, First Wave BioPharma has both the commercialization experience and scientific expertise to make waves in the biopharma industry.

Gastroenterology is the branch of medicine that focuses on issues with the digestive system. First Wave BioPharma, Inc. (formerly AzurRx BioPharma) is a clinical stage biopharmaceutical company specializing in the development of targeted, non-systemic therapies for gastrointestinal (GI) diseases.

The market for gastroenterologic therapeutics was over $46 billion in 2020 and is estimated to grow to over $62 billion by 2025 as per Research and Markets.

First Wave has a concerted focus on the treatment of Inflammatory Bowel Disease (IBD), a term generally used to refer to either ulcerative colitis or Crohn's disease. Research and Markets sees the global market for IBD treatments expanding to reach $29.2 billion in 2027, with a 8.1% CAGR from last year to 2027 in their forecast.

More specifically, Research and Markets predicts the size of the Crohn's disease treatment market to grow to $12.6 billion by 2029, representing a 5.5% CAGR for the decade.

Additionally, the market size of ulcerative colitis is projected to reach over $10 billion in the year 2027 as per a report from Reports and Data. Moreover, the COVID-19 pandemic has heightened issues regarding SARS-CoV-2 infection in inflammatory bowel disease (IBD) patients. According to a study published in the United European Gastroenterology Journal March 2021, patients with ulcerative colitis will typically have more adverse impacts from their infection than those without it.

First Wave 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 potentially a significant solution for ulcerative colitis, and the biologic adrulipase, a recombinant lipase enzyme designed to enable the digestion of fats and other nutrients.

A Robust Pipeline with Potential Solutions for a Host of Different Issues

First Wave BioPharma is advancing a therapeutic development pipeline populated 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 niclosamide and niclosamide, an oral small molecule with anti-inflammatory properties.

First Wave is developing these technologies for a host of GI diseases where there are significant unmet clinical needs and limited therapeutic options, resulting in painful, life threatening and discomforting consequences for patients. Our goal is to help protect the health and restore quality of life for the millions of people afflicted.

Adrulipase is a recombinant lipase enzyme for the treatment of exocrine pancreatic insufficiency (EPI) associated with cystic fibrosis (CF) and chronic pancreatitis (CP). Adrulipase, supplied as an oral, non-systemic, biologic capsule, is derived from the Yarrowia lipolytica yeast lipase and breaks up fat molecules in the digestive tract of EPI patients so that they can be absorbed as nutrients.

EPI is a condition characterized by deficiency of the exocrine pancreatic enzymes, resulting in a patient’s inability to digest food properly, or maldigestion. The deficiency in this enzyme can be responsible for greasy diarrhea, fecal urge and weight loss, including when those issues are found during a COVID-19 infection.

The digestive standard of care for both CF and chronic pancreatitis (CP) patients with EPI are commercially-available PERTs. Ideally, a stable daily dose of PERT will enable CF patients to eat a normal to high-fat diet and minimize unpleasant gastrointestinal symptoms. In practice, however, a substantial number of CF patients do not achieve normal absorption of fat with PERTs. Moreover, PERTs require the administration of as many as 40 pills per day and have potential issues with Black Box safety warnings.

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.

Niclosamide is an oral small molecule with anti-viral and anti-inflammatory properties that has been safely used on millions of patients worldwide. It is listed as an essential medicine by the World Health Organization (WHO) and was approved by the U.S. Food and Drug Administration (FDA) in 1982 for the treatment of intestinal tapeworm infections.

Recent discoveries in immune cell metabolism suggests that it is possible to selectively target disease-causing immune cells to treat inflammatory diseases without unwanted side effects such as broad immunosuppression. Research indicates that IBD, including ulcerative colitis, Crohn’s disease, and ulcerative proctitis/ proctosigmoiditis, is driven by pathogenic Th17 cells, which releases a cascade of local cytokines that in turn cause inflammation in bowel wall tissues. Th17 cells rely on a cellular process called oxidative phosphorylation to survive. Niclosamide is known to disrupt the oxidative phosphorylation in the mitochondria of pathogenic Th17 cells in a manner that selectively induces apoptosis of pathogenic Th17 cells, overcoming their inherent resistance to cell death. By killing Th17 cells, niclosamide reduces inflammation and calms the gut, selectively killing pathogenic, inflammatory cells while leaving healthy cells untouched.

First Wave’s suite of proprietary, gut-restricted niclosamide product candidates are designed to target the metabolism of disease-causing Th17 cells to potentially halt or delay the progression of disease, stop flare-ups, and address patient needs at all stages of IBD, from mild to severe, and for cancer patients with checkpoint-induced colitis.

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