First Wave BioPharma Stock Price, News & Analysis

First Wave BioPharma, Inc. (NASDAQ: FWBI), now operating under the name Entero Therapeutics, Inc., is a clinical-stage biopharmaceutical company focused on the research and development of targeted, non-systemic therapies for gastrointestinal (GI) diseases. According to its SEC registration statements, the company develops non-absorbable drugs that act locally in the intestinal lumen, skin, or mucosa without reaching systemic circulation. In May 2024, the company changed its corporate name from First Wave BioPharma, Inc. to Entero Therapeutics, Inc., while its historical common stock traded under the symbol FWBI on the Nasdaq Capital Market before transitioning to trade under the symbol ENTO.

Entero Therapeutics is headquartered in Boca Raton, Florida and is classified under pharmaceutical preparation manufacturing within the broader manufacturing sector. The company’s filings describe a business model centered on developing GI-focused biologics and small molecules, with an emphasis on late-stage clinical assets. Over time, its pipeline has evolved through internal development, in-licensing, and corporate transactions, including a merger with ImmunogenX, Inc., a private clinical-stage biopharmaceutical company founded in 2013.

Business focus and therapeutic approach

In its SEC filings, Entero Therapeutics states that it is engaged in the research and development of targeted, non-systemic therapies for patients with GI diseases. Non-systemic therapies are described as drugs that act locally without entering systemic circulation. This approach is applied to conditions where local activity in the GI tract is central to disease mechanisms and symptom relief.

The company’s more recent SEC disclosures indicate that it is currently focused on developing Adrulipase, a recombinant lipase enzyme biologic designed to enable the digestion of fats and other nutrients in patients with exocrine pancreatic insufficiency associated with cystic fibrosis and chronic pancreatitis. Earlier programs have included:

• Latiglutenase – a targeted oral biotherapeutic for celiac disease designed to break down gluten into non-immunogenic peptides.
• Capeserod – a selective 5-HT4 receptor partial agonist that was being developed as a therapeutic for gastroparesis and other GI indications.
• Niclosamide – an oral small molecule with anti-inflammatory properties for inflammatory bowel diseases such as ulcerative colitis and Crohn’s disease.

SEC registration statements note that the company has determined to discontinue the Latiglutenase, Capeserod, and Niclosamide programs, while focusing on Adrulipase. Earlier company news releases, however, describe periods when First Wave BioPharma was advancing a pipeline with multiple late-stage clinical programs built around proprietary technologies including latiglutenase, capeserod, and adrulipase for GI indications.

Corporate evolution and ImmunogenX merger

In March 2024, First Wave BioPharma announced the closing of a merger with ImmunogenX, Inc., a private clinical-stage biopharmaceutical company developing latiglutenase for the treatment of celiac disease. SEC filings describe this transaction as an all-stock merger in which ImmunogenX became ImmunogenX LLC, a wholly owned subsidiary of Entero Therapeutics. As consideration, the former shareholders of ImmunogenX received shares of common stock and shares of Series G Convertible Preferred Stock, and the company assumed ImmunogenX stock options and warrants, which became options and warrants to purchase Entero common stock.

Company news releases highlight that latiglutenase is an orally administered mixture of two gluten-specific recombinant proteases being developed as an oral biotherapeutic for celiac disease. Phase 2a and 2b clinical trials of latiglutenase are reported to have shown reductions in symptom severity and frequency, as well as mitigation of gluten-induced intestinal mucosal injury in celiac disease patients. The Phase 3 clinical development plan for latiglutenase was reviewed with the GI Division of the U.S. Food and Drug Administration at an End of Phase 2 meeting, with an agreed plan forward described in company communications.

Pipeline history and GI disease focus

Across its public communications and SEC filings, the company consistently characterizes itself as a GI-focused clinical-stage biopharmaceutical company. Historical and more recent disclosures describe:

• Adrulipase as a recombinant lipase enzyme biologic designed to enable digestion of fats and nutrients in cystic fibrosis and chronic pancreatitis patients with exocrine pancreatic insufficiency.
• Latiglutenase as a potentially first-in-class targeted oral biotherapeutic for celiac disease, composed of two gluten-specific recombinant proteases and minimally systemically absorbed.
• Capeserod as a selective 5-HT4 receptor partial agonist in-licensed from Sanofi and developed for gastroparesis and other GI indications.
• Niclosamide as an oral small molecule with anti-inflammatory properties for inflammatory bowel diseases.

News releases also describe scientific work around celiac disease diagnostics and mucosal health assessment, including abstracts and invited papers on topics such as a composite mucosal scale (VCIEL) and serologic changes to gluten exposure in celiac disease patients. These research efforts are framed as supporting the clinical development of latiglutenase and contributing to the broader field of celiac disease research.

Capital markets activity and listing status

Historically, the company’s common stock traded on the Nasdaq Capital Market under the symbol FWBI when it was known as First Wave BioPharma, Inc. SEC filings and later registration statements indicate that the common stock is now listed on the Nasdaq Capital Market under the symbol ENTO for Entero Therapeutics, Inc. The company has undertaken multiple registered direct offerings and private placements, as described in its news releases and Form 8-K filings, to fund working capital and general corporate purposes.

SEC filings detail corporate actions such as a reverse stock split of common stock at a 1-for-3 ratio, approved by stockholders and effected through a certificate of amendment to the company’s certificate of incorporation. The reverse split was implemented to increase the per-share bid price of the common stock in connection with Nasdaq listing requirements. Other filings describe interactions with Nasdaq regarding compliance with stockholders’ equity and annual meeting rules, as well as extensions granted to regain compliance.

Regulatory and reporting framework

Entero Therapeutics, Inc. is incorporated in Delaware and files periodic and current reports with the U.S. Securities and Exchange Commission. Its registration statements and 8-K filings provide information on its GI-focused research and development programs, capital structure, financing transactions, and corporate governance matters. These documents also describe the company’s status as a smaller reporting company and the associated reporting framework.

FAQs about First Wave BioPharma (Entero Therapeutics)

• What is First Wave BioPharma, Inc. (FWBI)?
  First Wave BioPharma, Inc. was the corporate name used by a clinical-stage biopharmaceutical company specializing in targeted, non-systemic therapies for gastrointestinal diseases. According to SEC filings, in May 2024 the company changed its name to Entero Therapeutics, Inc.
• What does Entero Therapeutics focus on today?
  SEC registration statements state that Entero Therapeutics is engaged in the research and development of targeted, non-systemic therapies for GI diseases and is currently focused on developing Adrulipase, a recombinant lipase enzyme for exocrine pancreatic insufficiency in cystic fibrosis and chronic pancreatitis patients.
• How did latiglutenase become part of the company’s pipeline?
  In March 2024, the company announced the closing of a merger with ImmunogenX, Inc., a private clinical-stage biopharmaceutical company developing latiglutenase for celiac disease. As a result of the merger, ImmunogenX became a wholly owned subsidiary and latiglutenase was added to the GI-focused clinical pipeline.
• What are non-systemic therapies as described by the company?
  The company’s SEC filings define non-systemic therapies as non-absorbable drugs that act locally in areas such as the intestinal lumen, skin, or mucosa without reaching systemic circulation. Entero Therapeutics applies this concept to therapies for GI diseases.
• Which programs has the company discontinued?
  Recent SEC registration statements report that the company has determined to discontinue its programs for latiglutenase, capeserod, and niclosamide, while focusing on the development of Adrulipase.
• Where is Entero Therapeutics headquartered?
  SEC filings list the principal executive offices of Entero Therapeutics, Inc. in Boca Raton, Florida.
• On which exchange does the company’s stock trade now?
  According to SEC filings, the company’s common stock is listed on the Nasdaq Capital Market under the trading symbol ENTO. Historically, when operating under the name First Wave BioPharma, Inc., the stock traded under the symbol FWBI.
• What role did ImmunogenX play in the company’s history?
  ImmunogenX, Inc. was a private clinical-stage biopharmaceutical company founded in 2013 and developing latiglutenase for celiac disease. Following the merger described in SEC filings, ImmunogenX became ImmunogenX LLC, a wholly owned subsidiary of Entero Therapeutics, and its programs and intellectual property were integrated into the combined company’s GI pipeline.