AzurRx SAS

AzurRx BioPharma Inc., a company specializing in the development of targeted, non-systemic therapies for gastrointestinal (GI) diseases, has entered a definitive agreement to acquire First Wave Bio, Inc. in a stock and cash transaction valued at $229 million, including certain development, regulatory and sales milestones. First Wave Bio is a clinical-stage biotechnology company specializing in the development of novel, gut-targeted, small molecule therapies for auto-immune inflammatory bowel diseases (IBD) and other serious conditions. In conjunction with the acquisition, AzurRx is changing its corporate name to “First Wave BioPharma, Inc.” As part of the plan, First Wave BioPharma will trade its common shares on Nasdaq under the new ticker symbol, “FWBI,” which is anticipated to be effective on or about Thursday, September 23, 2021. In addition, the company will launch a new website. AzurRx’s management team, including James Sapirstein, chairman, president, and chief executive officer, will continue to lead the renamed company. “The acquisition of First Wave Bio, and the creation of First Wave BioPharma Inc. is a transformative event that significantly expands our GI development pipeline and positions our company for new growth opportunities in the inflammatory bowel disease therapeutic space,” stated Sapirstein. “Our portfolio now includes new indications for several IBDs that represent multi-billion dollar commercial market opportunities. In the U.S. last year, it is estimated that there were more than 850,000 ulcerative colitis diagnoses and 625,000 Crohn’s disease diagnoses, and these patient populations and markets are expected to grow substantially over the next decade. We believe that our proprietary formulations of niclosamide, with their novel anti-inflammatory mechanism of action, non-systemic absorption, and safety benefits, will enable us to address significant unmet clinical needs for IBD patients, especially in the mild-to-moderate disease categories. With our expanded pipeline and new IBD indications, we expect strong growth and increased shareholder value.” Per the definitive agreement, AzurRx will wholly own all rights to First Wave Bio’s proprietary formulations of niclosamide, a small molecule drug which features anti-viral and anti-inflammatory properties that are designed to address multiple GI conditions. Further, AzurRx will have sole ownership of First Wave Bio’s robust intellectual property (IP) portfolio, which covers method of use and delivery of these formulations as treatments for various auto-immune, inflammatory and viral conditions. In January 2021, AzurRx in-licensed from First Wave Bio the exclusive global rights to develop two niclosamide therapeutic indications – for COVID-19-related GI infections, and for immune checkpoint inhibitor-associated colitis and diarrhea (ICI-AC) in advanced stage cancer patients. Following the acquisition of First Wave Bio, AzurRx’s internal development pipeline will include three new clinical IBD indications in ulcerative proctitis (UP) and ulcerative proctosigmoiditis (UPS), ulcerative colitis (UC), and Crohn’s disease (CD). James Pennington, M.D., chief medical officer of AzurRx, commented, “There is a wealth of clinical data that supports the antiviral and anti-inflammatory capabilities of niclosamide. More recently, data generated by First Wave Bio in ulcerative proctitis supported the broader potential for niclosamide in multiple inflammatory bowel diseases where we believe our niclosamide formulations could offer significant advantages over other currently available treatments including steroids, 5-ASAs, and biologics – especially in the mild-to-moderate disease stage.” Sapirstein added, “We will now be advancing a pipeline that spans six indications and includes several clinical-stage programs. These programs are all built around our two proprietary technologies -- niclosamide, and adrulipase (MS1819), which we are continuing to develop as a treatment for exocrine pancreatic insufficiency (EPI), a life-threatening digestive disorder seen in patients with cystic fibrosis and chronic pancreatitis. With multiple clinical trials advancing and others to soon initiate, along with a strong portfolio of long-lasting patents protecting niclosamide’s use for COVID-19 GI infections, ICI-AC and the IBDs, the next several years should be rich in milestones as we continue to advance our development programs, generate data, and bring new assets into the clinic.” Gary D. Glick, CEO and founder of First Wave Bio, said, “We believe the acquisition of First Wave Bio by AzurRx will unlock the value of our proprietary niclosamide formulations targeting IBD. We are confident that the AzurRx team will successfully advance these programs along their respective clinical and regulatory pathways.” H.C. Wainwright & Co. acted as advisor to AzurRx in connection with the acquisition.

DELRAY BEACH, Fla., May 12, 2021 (GLOBE NEWSWIRE) -- AzurRx BioPharma, Inc. (NASDAQ: AZRX), (“AzurRx” or the “Company”), a clinical stage biopharmaceutical company specializing in the development of targeted, non-systemic therapies for gastrointestinal (GI) diseases, today announced that AzurRx SAS, its wholly-owned subsidiary in France, has received approximately 459,000 Euros ($550,000 U.S.) in non-dilutive funding in research tax credits from the French government for its 2020 CIR (French Research Tax Credit). James Sapirstein, Chief Executive Officer of AzurRx commented, “We are very thankful for the French government’s continued support and pleased to receive the 2020 CIR. These funds have enabled us to successfully run the European arms of our two Phase 2 MS1819 clinical trials - despite the challenges posed by the COVID epidemic. We plan to re-invest the CIR funds in our ongoing, European-based clinical trials which are anticipated to complete in 2021.” The French R&D tax credit initiative (“Crédit d’Impôt Recherche”, or CIR) gives eligible research-based French companies, which are subject to corporate tax in France, the ability to claim tax relief of up to 30% on costs incurred in R&D activities in France and the European Union. Previously received CIR funds have been by AzurRx to support its MS1819 clinical program for the treatment of exocrine pancreatic insufficiency (EPI) in cystic fibrosis (CF) patients in Europe, including both the ongoing Phase 2 Combination trial, evaluating MS1819 in combination with PERT (porcine-derived pancreatic enzyme replacement therapy) in CF patients with severe EPI, and the Phase 2b OPTION 2 MS1819 monotherapy clinical trial. About CIRThe Research Tax Credit (CIR) is a tax incentive provided by the French Government to encourage the growth of businesses' competitiveness by favoring research and development (R&D) and innovative activities. It is particularly adapted to the needs of small and medium-sized enterprises. About AzurRx BioPharma, Inc.AzurRx BioPharma, Inc. (NASDAQ: AZRX) is a clinical stage biopharmaceutical company specializing in the development of targeted, non-systemic therapies for gastrointestinal (GI) diseases. The Company has a pipeline of three gut-restricted GI assets. The lead therapeutic drug candidate is MS1819, a recombinant lipase for the treatment of exocrine pancreatic insufficiency (EPI) in patients with cystic fibrosis and chronic pancreatitis. AzurRx is also advancing two clinical programs using proprietary formulations of niclosamide, a pro-inflammatory pathway inhibitor; FW-1022, for COVID-19 GI infections and FW-420, for Grade 1 Immune Checkpoint Inhibitor-Associated Colitis and diarrhea in oncology patients. The Company is headquartered in Delray Beach, Florida, with clinical operations in Hayward, California. For more information visit . Forward-Looking StatementThis 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; 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:AzurRx BioPharma, Inc.1615 South Congress Avenue Suite 103Delray Beach, Florida 33445Phone: (646) 699-7855info@azurrx.com Media contact:Tiberend Strategic Advisors, Inc.Johanna Bennett/Ingrid Mezo(212) 375-2665/(646) 604-5150jbennett@tiberend.com/imezo@tiberend.com