First Wave BioPharma Announces Restructuring of Merger Consideration Payment Terms with Former First Wave Bio Shareholders

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BOCA RATON, Fla., Nov. 16, 2021 (GLOBE NEWSWIRE) — First Wave BioPharma, Inc. (NASDAQ: FWBI), (“First Wave BioPharma” or the “Company”), a clinical-stage biopharmaceutical company specializing in the development of targeted and non-systemic therapies for gastrointestinal (GI) diseases, announced today that it has agreed with the former shareholders of First Wave Bio, Inc. (“FWB”) to modify the payment structure of the initial consideration of merger and extend payments through 2023 to provide the Company with additional financial resources for its ongoing Phase 2 clinical trial programs.

On September 13, 2021, the Company announced the acquisition of FWB and paid FWB an initial cash payment of $3 million and issued $4 million of common stock. The initial remaining initial consideration of $15 million ($8 million due October 28, 2021 and $7 million due March 31, 2022) has been restructured. Under the revised merger agreement, this $15 million will be paid in smaller monthly installments beginning in January 2022 through mid-2023, until satisfied.

The $2 million milestone payment, triggered on the patient’s first dose in the FW-UP Phase 2 clinical trial for ulcerative proctitis, which was announced on October 14, 2021, is paid immediately and simultaneously time as the signing of the revised merger agreement.

James Sapirstein, President and CEO of First Wave BioPharma, said, “We are very pleased to have been able to restructure the remaining $15 million in consideration from former FWB shareholders. This revised agreement provides us with additional capital resources to advance our clinical programs through several value improvement milestones in 2022.”

About First Wave BioPharma, Inc.
The Company 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 comprised of multi-stage clinical programs built around its two proprietary technologies – niclosamide, an oral small molecule with antiviral and anti-inflammatory properties, and biological adrulipase, a recombinant lipase enzyme. designed to allow the digestion of fats and other nutrients. The Company’s niclosamides portfolio is led by two clinical programs in Phase 2 clinical trials: FW-COV, for COVID-19 gastrointestinal infections and FW-UP, for ulcerative proctitis (UP) and ulcerative rectosigmoiditis. Three additional indications for niclosamide, FW-ICI-AC, for colitis and diarrhea associated with immune checkpoint inhibitors grade 1 and grade 2 in advanced oncology patients, FW-UC (ulcerative colitis) and FW- CD (Crohn’s disease) is expected to enter the clinic in 2022 and 2023. The Company is also advancing FW-EPI (adrulipase) for the treatment of pancreatic exocrine insufficiency (EPI) in patients with cystic fibrosis and pancreatitis chronic. The company is headquartered in Boca Raton, Florida. For more information, visit www.firstwavebio.com.

Forward-looking statement
This press release may contain certain statements regarding future results that are forward-looking statements. It is possible that the Company’s actual results and financial condition may differ, perhaps materially, from the anticipated results and financial condition indicated in these forward-looking statements, depending on factors, including whether results obtained in preclinical studies and non-clinical and clinical trials will be indicative of results obtained in future clinical trials; whether preliminary or interim results of a clinical trial will be indicative of the final results of the trial; the size of potential markets for the Company’s drug candidates and its ability to serve these markets; the effects of the acquisition of First Wave Bio, Inc. and its announcement on the Company’s business, results of operations and financial outlook; the integration of the First Wave Bio, Inc. business with the Company’s own business; and the Company’s current and future capital needs and its ability to raise additional funds to meet its capital needs. Additional information regarding the Company and its business, including a discussion of factors that could materially affect the Company’s financial results, is contained in the Company’s Annual Report on Form 10-K for the fiscal 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 undertake no obligation to publicly update or correct any forward-looking statements to reflect events or circumstances that occur subsequently or of which we become aware subsequently.

For more information:
First Wave BioPharma, Inc.
777 Yamato Road, Suite 502
Boca Raton, Florida 33431
Telephone: (561) 589-7020
info@firstwavebio.com

Media contact:
Tiberend Strategic Advisors, Inc.
Johanna Bennett/David Schemelia
(212) 375-2665 / (609) 468-9325
jbennett@tiberend.com / dschemelia@tiberend.com

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