First Wave BioPharma, Inc.

President and CEO James Sapirstein brings over 40 years of pharmaceutical experience to First Wave BioPharma, having held key positions at major companies, including Eli Lilly, Hoffman-LaRoche, Bristol Myers Squibb, and Gilead. He led the Global Marketing Team at Gilead and was instrumental in the market launch of their blockbuster HIV drugs, Viread and Truvada.

Mr. Sapirstein also co-founded Tobira Therapeutics, which was later acquired by Allergan for $1.7 billion, demonstrating his ability to create substantial value. With over 25 drug launches under his belt, he possesses the expertise needed to commercialize First Wave's therapies.

Additionally, First Wave has assembled an esteemed Scientific Advisory Board and Clinical Steering Committees. This exceptional scientific knowledge will be invaluable as the company advances its promising gastrointestinal pipeline focused on unmet medical needs.

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

According to Research and Markets, the market for gastroenterologic therapeutics continues to grow, estimated to reach over $62 billion by 2025.

Source: researchandmarkets.com

First Wave is focused on treating inflammatory bowel disease (IBD), including ulcerative colitis and Crohn's disease. The IBD treatment market is projected to reach $29.2 billion by 2027 with an 8.1% CAGR, according to Research and Markets.

Source: KBV Research

First Wave's lead product candidate is adrulipase, a recombinant enzyme being developed as an oral capsule for exocrine pancreatic insufficiency (EPI) in patients with cystic fibrosis and chronic pancreatitis. In January 2023, the company initiated a Phase 2b bridging study of an improved formulation of adrulipase. First Wave continues efforts to advance its pipeline of non-systemic GI therapies.

First Wave BioPharma is developing targeted, non-systemic therapies for gastrointestinal (GI) diseases. The company's pipeline focuses on advancing its lead product candidate, adrulipase.

Adrulipase is a recombinant lipase enzyme being developed as an oral capsule for treating exocrine pancreatic insufficiency (EPI) in patients with cystic fibrosis and chronic pancreatitis.

In January 2023, First Wave initiated a Phase 2b bridging study evaluating an improved enteric microgranule formulation of adrulipase in cystic fibrosis patients with EPI. While initial data from this study showed the new formulation was safe and improved over prior versions, efficacy results were inconclusive. Additional data is expected in Q3 2023.

Source: Company Reports

Adrulipase is a recombinant lipase enzyme being developed by First Wave BioPharma as an oral capsule for treating exocrine pancreatic insufficiency (EPI) in patients with cystic fibrosis (CF) and chronic pancreatitis (CP).

EPI is a condition characterized by a deficiency of pancreatic digestive enzymes, resulting in a patient’s inability to digest food and absorb nutrients properly.

The current standard of care is porcine-derived pancreatic enzyme replacement therapy (PERT). However, PERTs have limitations, including a high daily pill burden and potential safety issues.

In developing adrulipase, First Wave aims to provide an effective, non-animal-derived therapy to control EPI while reducing the daily pill burden.

In January 2023, the company initiated a Phase 2b bridging study evaluating an improved enteric microgranule formulation of adrulipase in CF patients with EPI. Additional data is expected in Q3 2023 as First Wave continues working to optimize the adrulipase formulation.

Capeserod: Unique Mechanism of Action Applicable to New GI Indications

• Capeserod, a selective 5-HT4 receptor partial agonist, was in-licensed from Sanofi in September 2023

• In previous Sanofi Phase 1 and Phase 2 CNS trials involving over 600 patients, Capeserod appeared safe and well-tolerated

• Research on Capeserod and subsequent artificial intelligence (AI)-empowered analyses suggest that the drug possesses a unique mechanism of action that is applicable to several GI indications underserved by currently available therapeutics in multi-billion dollar markets.

– Pediatric Ulcerative Colitis

– Gastroparesis

– Constipation

• First Wave will repurpose Capeserod for gastrointestinal (GI) indications and plans to initiate a Phase 2 clinical development program

• In September 2023, First Wave announced an agreement with Sanofi (NASDAQ: SNY) to license Capeserod.

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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Information, opinions and estimates contained on this page or in the Company Presentation reflect judgments by the Company as of the original date of publication by the Company and are subject to change without notice. Past performance should not be taken as an indication or guarantee of future performance, and no representation or warranty, express or implied is made regarding future performance.

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