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First Wave BioPharma Changes Name to Entero Therapeutics

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Entero Therapeutics, formerly First Wave BioPharma, has rebranded to reflect its focus on gastrointestinal (GI) diseases. The company, now trading under the ticker 'ENTO' effective May 17, 2024, is advancing toward a Phase 3 trial for latiglutenase. This lead asset has shown promise in Phase 2 trials for treating celiac disease, a condition with no current approved treatments. The rebranding follows the acquisition of ImmunogenX and aims to align with Entero's mission to address unmet needs in GI health. The Phase 3 trial is expected to commence in early 2025. Entero will also participate in Celiac Awareness Month by partnering with Celiac Journey for a digital display at the Nasdaq Tower in Times Square.

Positive
  • Rebranding and new ticker symbol 'ENTO' effective May 17, 2024, may attract new investors.
  • Advancement towards Phase 3 clinical trial for latiglutenase, addressing a significant unmet need in celiac disease.
  • Positive results from three Phase 2 trials for latiglutenase.
  • Business combination with ImmunogenX provides additional resources and expertise.
  • Focus on non-systemic therapies for gastrointestinal diseases aligns with market needs.
  • Participation in Celiac Awareness initiatives may boost brand visibility.
Negative
  • Pending Phase 3 trial initiation in early 2025 introduces potential delays.
  • No currently approved treatments for celiac disease could suggest high risk in clinical development.
  • Rebranding costs and integration with ImmunogenX could strain financial resources.
  • Uncertainty regarding the market acceptance of latiglutenase if approved.

Rebranding introduced as Company advances toward Phase 3 clinical trial with lead asset – latiglutenase for the treatment of celiac disease

New Nasdaq ticker symbol is “ENTO” effective May 17, 2024

BOCA RATON, Fla., May 16, 2024 (GLOBE NEWSWIRE) -- Entero Therapeutics, Inc. (formerly First Wave BioPharma, Inc.) (Nasdaq: ENTO) (“Entero” or the “Company”), a late clinical-stage biopharmaceutical company focused on the development of targeted, non-systemic therapies for gastrointestinal (GI) diseases, today unveiled its new corporate name and website. The rebranding follows the recent business combination with ImmunogenX and reflect the Company’s focus on addressing unmet needs in GI health that include celiac disease, an indication for which there are no approved medicines today. Entero’s common stock will commence trading on May 17, 2024, on the Nasdaq Capital Market under the new ticker symbol of ENTO.

James Sapirstein, Chairman and Chief Executive Officer of Entero Therapeutics, said, “The rebranding aligns our corporate identity with our mission of bringing to market new treatments for the gut and intestine. We have accelerated this by adding latiglutenase to our pipeline. This is an opportunity to address significant medical need and market opportunity for celiac disease. As we prepare for a Phase 3 study with this program and advance our other drug candidates, we want to make sure that our branding better reflects the Company’s GI focus.”

Latiglutenase is an oral biotherapeutic composed of two gluten-specific recombinant proteases that has demonstrated effectiveness in alleviating GI symptoms of celiac disease and protecting against intestinal damage in three Phase 2 trials. The Phase 3 clinical plan for latiglutenase has been reviewed by the GI Division of the FDA, and the Company expects to initiate the trial in early 2025.

Today, in honor of Celiac Awareness Month in May, Entero will partner with Celiac Journey, a celiac disease patient advocacy organization, to share an awareness digital display on the Nasdaq Tower in Times Square at 4:25 p.m. ET. The digital display will also be shown at night as part of the international “Shine a Light on Celiac Disease” initiative to illuminate famous landmarks in green.

For more information about Entero Therapeutics, visit www.enterothera.com and connect on X and LinkedIn.

About Entero Therapeutics

Entero Therapeutics, Inc., is a late clinical-stage biopharmaceutical company focused on the development of targeted, non-systemic therapies for gastrointestinal (GI) diseases. The Company’s programs address significant unmet needs in GI health and include: latiglutenase, a Phase 3-ready, potentially first-in-class, targeted, oral biotherapeutic for celiac disease; capeserod, a selective 5-HT4 receptor partial agonist for indications including gastroparesis; and adrulipase, a recombinant lipase enzyme designed to enable the digestion of fats and other nutrients in cystic fibrosis and chronic pancreatitis patients with exocrine pancreatic insufficiency. For more information visit www.enterothera.com

Forward-Looking Statements 
This 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 any financing or licensing transaction may be completed, completed with different terms, in an untimely manner, or not at all; whether the Company will be able to realize the expected benefits of its acquisition of ImmunogenX; the Company’s ability to integrate the assets and contemplated commercial operations acquired from ImmunogenX into the Company’s business; 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; whether the Company will be able to maintain compliance with Nasdaq’s continued listing criteria and the effect of a delisting from Nasdaq on the market for the Company’s securities; the size of the potential markets for the Company’s drug candidates and its ability to service those markets; the effects of the First Wave Bio, Inc. acquisition, the related settlement and their effect on the Company’s business, operating results and financial prospects; 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, 2023, filed with the Securities and Exchange Commission (“SEC”) on March 29, 2024, as well as the Company’s subsequent filings with the SEC, including its proxy statements on Schedule 14A, Quarterly Report on Form 10-Q and Current Reports on Form 8-K. 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: 
Entero Therapeutics, Inc. 
777 Yamato Road, Suite 502 
Boca Raton, FL 33431 
Phone: (561) 589-7020 
info@enterothera.com 

Media contact: 
Russo Partners
David Schull or Liz Phillips
(347) 956-7697
david.schull@russopartnersllc.com
elizabeth.phillips@russopartnersllc.com 


FAQ

What is Entero Therapeutics' new ticker symbol?

Entero Therapeutics' new ticker symbol is 'ENTO', effective May 17, 2024.

What is Entero Therapeutics focusing on?

Entero Therapeutics is focusing on the development of targeted, non-systemic therapies for gastrointestinal diseases.

When will Entero Therapeutics start trading under the new ticker symbol 'ENTO'?

Entero Therapeutics will start trading under the new ticker symbol 'ENTO' on May 17, 2024.

What is latiglutenase?

Latiglutenase is an oral biotherapeutic composed of two gluten-specific recombinant proteases, aimed at treating celiac disease.

When will the Phase 3 trial for latiglutenase begin?

The Phase 3 trial for latiglutenase is expected to begin in early 2025.

Which organization is Entero Therapeutics partnering with for Celiac Awareness Month?

Entero Therapeutics is partnering with Celiac Journey for Celiac Awareness Month.

First Wave BioPharma, Inc.

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BOCA RATON