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 ranging from complications from cancer treatment to nutritional disorders and diseases brought on by viral infections and immune malfunction.
Disease targets include large patient populations with inflammatory bowel diseases (ulcerative colitis and Crohn’s), digestive disorders (exocrine pancreatic insufficiency in cystic fibrosis patients), and the COVID-19 pandemic (acute and long-haul COVID-related GI infections).
PIPELINE
First Wave BioPharma’s GI-disease focused programs span multiple clinical indications ranging from complications from cancer treatment to nutritional disorders and diseases brought on by viral infections and immune malfunction.
Disease targets include large patient populations with inflammatory bowel diseases (ulcerative colitis and Crohn’s), digestive disorders (exocrine pancreatic insufficiency in cystic fibrosis patients), and the COVID-19 pandemic (acute and long-haul COVID-related GI infections).
DEVELOPMENT STORY
First Wave BioPharma is 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 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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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.
Daniel Schneiderman
Chief Financial Officer
Daniel Schneiderman was appointed as Chief Financial Officer of the Company in January 2020. Mr. Schneiderman is seasoned finance executive with over 18 years of experience in the areas of capital markets and finance operations. Prior to joining the Company, from November 2018 through December 2019 Mr. Schneiderman served as Chief Financial Officer of Biophytis SA, and its U.S. subsidiary, Biophytis, Inc., a European-based, clinical-stage biotechnology company focused on the development of drug candidates for age-related diseases, with a primary focus on neuromuscular diseases. From February 2012 through August 2018, Mr. Schneiderman served as Vice President of Finance, Controller and Secretary of MetaStat, Inc. (OTC: MTST), a publicly traded biotechnology company with a focus on Rx/Dx precision medicine solutions to treat patients with aggressive (metastatic) cancer. Mr. Schneiderman began his career at Burnham Hill Partners LLC, a division of Pali Capital, Inc., a boutique investment bank providing capital raising, advisory and merchant banking services in February 2004, where he served in various roles and increasing responsibilities, including as Vice President of Investment Banking until January 2012. Mr. Schneiderman holds a bachelor’s degree in economics from Tulane University.
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.
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.
Risks & Disclosures
This communication is neither an offer to sell nor a solicitation of an offer to buy, nor a recommendation of any securities of the company mentioned herein.
First Wave BioPharma (the “Company”) and its counsel have reviewed the content of this page as well as the accompanying presentation (“Company Presentation”) displayed on this page. To the best of its knowledge, the Company does not believe this content to be misleading or inaccurate in any material respect, nor does it believe there are any material omissions with respect to such content. The Company does not believe the contents of the page or the Company Presentation to contain any non-public material information.
Information and opinions presented in the Company Presentation are provided by the Company, and b2i digital makes no representation as to their accuracy or completeness. The information contained on this page is not intended to constitute any form of advice, and the information provided is not intended to provide a sufficient basis on which to make an investment decision. It is not investment research, nor does it constitute a research recommendation, as it does not constitute substantive research or analysis. This information is not to be relied upon in substitution for the exercise of independent judgment.
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.
A complete description of the risks and uncertainties relating to the Company and its securities can be found in the company's filings with the U.S. Securities and Exchange Commission available for free at www.sec.gov.
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