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.
Nasdaq: FWBI
IR Website: https://firstwavebio.com/investors/overview
Headquarters: Boca Raton, FL
Content provided by First Wave BioPharma on 2-14-22.
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Summary
Targeted, Non-Systemic Therapies for Gastrointestinal Diseases
THE SCIENCE
First Wave BioPharma’s GI-disease focused programs span multiple clinical indications. Disease targets include large patient populations with nutritional digestive disorders (exocrine pancreatic insufficiency in cystic fibrosis and chronic pancreatitis patients), inflammatory bowel diseases (ulcerative colitis and Crohn’s), and autoimmune diarrhea and colitis complications from the use of immune checkpoint inhibitors to treat late-stage cancers.
PIPELINE
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, 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.
DEVELOPMENT STORY
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, 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.
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Investor Presentation
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Leadership In Commercialization
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.
The Gastroenterology Market
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.
First Wave Pipeline
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
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
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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Management Overview
James Sapirstein
Chairman, President & CEO
James Sapirstein has served over thirty-seven years in the pharmaceutical industry. He is currently the Chairman, CEO and President of First Wave BioPharma (NASDAQ: FWBI).
He began his career in 1984 with Eli Lilly, moving to Hoffmann-LaRoche in 1987, where he served for almost a decade on various commercial teams in the US and Internationally. He joined Bristol Myers Squibb as the Director of International Marketing in the Infectious Diseases group in 1996. While at BMS, he worked on several important HIV/AIDS projects including Secure the Future.
Mr. Sapirstein started his career in smaller biotech companies when he later joined Gilead Sciences, Inc. (GILD) in order to lead the Global Marketing team in its launch of Viread (tenofovir). In 2002, he accepted the position of Executive Vice President, Metabolic and Endocrinology, for Serono Laboratories. Later, in 2006, he became the founding CEO of Tobira Therapeutics, then a private company. Tobira Therapeutics was acquired by Allergan in 2016. In 2012, Mr. Sapirstein became the CEO of Alliqua, Inc. Thereafter, he served as CEO of Contravir Pharmaceuticals from March 2014 until October 2018. All of these are publicly listed companies. Mr. Sapirstein has raised over $300 Million dollars in venture capital and public capital markets financing in his various engagements as CEO. He was named as a Finalist for Ernst&Young Entrepreneur of the Year award in 2015 as well as in 2016.
Mr. Sapirstein holds board positions on Enochian Biosciences (ENOB:NASDAQ), and Blue Water Acquisition SPAC (BLUWU:NASDAQ). He was 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.
Mr. Sapirstein received BS (Pharmacy) from Rutgers University in 1984 and an MBA from Fairleigh Dickinson University in 1997.
James Pennington
Chief Medical Officer
Previous to joining First Wave BioPharma, Dr. Pennington spent eleven years at Anthera Pharmaceuticals as Chief Medical Officer and Senior Clinical Fellow. Prior that, he has held senior medical positions in a number of biopharmaceutical companies, including InterMune, Cotherix, and Bayer Pharmaceutical. Dr. Pennington has led registration efforts for twelve successful BLA/NDA submissions in the U.S. and another ten in Europe and Asia. Prior to joining the biotech industry, Dr. Pennington spent ten years on the Medical Faculty of Harvard Medical School. Dr. Pennington received his medical degree from the University of Oregon Health Sciences University and is boarded in internal medicine and infectious diseases.
Sarah Romano
Chief Financial Officer
Sarah Romano, CPA, was appointed as Chief Financial Officer of First Wave BioPharma in March 2022. She previously served as Chief Financial Officer of Kiora Pharmaceuticals, Inc. (NASDAQ: KPRX) (formerly EyeGate Pharmaceuticals, Inc.), a clinical-stage specialty pharmaceutical company developing products for treating ophthalmic diseases, from February 2017 through February 2022 and as its Corporate Controller from August 2016 to January 2017. Prior to joining Kiora, Ms. Romano served as Assistant Controller at TechTarget from June 2015 through August 2016 and Corporate Controller at Bowdoin Group, a healthcare-focused executive recruiting firm, from September 2013 through May 2015. Previously, she held financial reporting positions of increasing responsibility at SoundBite Communications from 2008 until its acquisition by Genesys in 2013, and at Cognex Corporation from 2004 through 2008. Ms. Romano began her career as an Auditor in the Boston office of PricewaterhouseCoopers. A licensed CPA in Massachusetts, she holds a Bachelor of Arts in Accounting from College of the Holy Cross and a Master of Accounting from Boston College.
Martin Krusin
Senior VP for Corporate Development
Mr. Krusin is an experienced executive with 20 years of business development, strategic marketing, financing and operating experience in the healthcare, financial services, and consulting sectors. Prior to joining First Wave BioPharma as VP for Business Development in 2014, Mr. Krusin was VP for BD at FluoroPharma Medical, Inc.; Director of Business Development at Clewed (a business services and investment partnership); an Experienced Commercial Leader at GE Capital in its Global Sponsor Finance, Healthcare Financial Services, and Capital Solutions units; Vice President of Marketing & Sales and Director of Business Development at Electro-Optical Sciences (MelaSciences); and an analyst in the Emerging Markets Strategic Planning Group at Citigroup. He has also served as a mentor, business coach and head of coaching to over 20 life-science starts-ups, spanning therapeutics, diagnostics, medical devices, healthcare IT, and bio-materials, in the ELab NYC EDC entrepreneurship program from 2016 to the present. Mr. Krusin received an MBA from Columbia Business School in finance and marketing, an MPhil. in political economy from Oxford University, and a BA in international relations from Swarthmore College.
Risks & Disclosures
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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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