Antibe Announces FDA Clinical Hold on Otenaproxesul and Legal Action by Nuance

Rhea-AI Summary

Antibe Therapeutics Inc. (ATBPF) received verbal notice from the FDA placing otenaproxesul on clinical hold, delaying the Phase II trial. Nuance Pharma initiated legal action seeking enforcement of an arbitration award. Antibe forms an Executive Committee to address operational and governance matters.

Positive

• None.

Negative

• The FDA placing otenaproxesul on clinical hold delays the planned Phase II trial, impacting the company's drug development timeline.
• Legal action by Nuance Pharma could result in potential legal and financial implications for Antibe.
• The formation of an Executive Committee may indicate internal challenges or issues within the company that require special attention.

TORONTO--(BUSINESS WIRE)-- Antibe Therapeutics Inc. (“Antibe” or the “Company” TSX: ATE, OTCQX: ATBPF) today announced that it received verbal notice on the afternoon of March 28, 2024 from the U.S. Food and Drug Administration (“FDA”) that otenaproxesul has been placed on clinical hold, postponing the initiation of the planned Phase II trial. Antibe expects to receive a formal Clinical Hold Letter from the FDA within 30 days outlining their rationale and further details.

Separately, the Company announced that Nuance Pharma Limited has commenced legal action in the Ontario Superior Court of Justice to seek recognition of and enforce the arbitration award in Ontario previously announced by Antibe in its press release of March 4, 2024. Nuance Pharma is seeking the appointment of a receiver as part of its relief; a hearing date has not been set.

In light of these developments and to better coordinate operational and governance matters, the Company's Board of Directors is forming an Executive Committee composed of Robert E. Hoffman, Chair of the Board; Dan Legault, CEO; and Yung Wu, Member of the Board.

Antibe will promptly inform the market when any additional material information is available.

About Antibe Therapeutics Inc.

Antibe is a clinical-stage biotechnology company leveraging its proprietary hydrogen sulfide platform to develop next-generation therapies to target pain and inflammation arising from a wide range of medical conditions. The Company’s current pipeline includes assets that seek to overcome the gastrointestinal ulcers and bleeding associated with nonsteroidal anti-inflammatory drugs (“NSAIDs”). Antibe’s lead drug, otenaproxesul, is in clinical development as a safer alternative to opioids and today’s NSAIDs for acute pain. Antibe’s second pipeline drug, ATB-352, is being developed for a specialized pain indication. The Company’s next target is inflammatory bowel disease (“IBD”), a condition long in need of safer, more effective therapies. Learn more at antibethera.com.

Forward Looking Statements

This news release includes certain forward-looking statements under applicable securities laws, which may include, but are not limited to, statements concerning the anticipated scope, timing, duration and completion of certain of the Company’s pre-clinical and clinical trial programs and studies including the Phase II trial’s timeline for initiation and completion and the anticipated timing for seeking market approval for certain of the Company’s drugs and therapies for certain additional indications, and Nuance Pharma’s seeking recognition of the arbitration award in Ontario. Any statements contained herein that are not statements of historical facts may be deemed to be forward-looking, including those identified by the expressions “will”, “anticipate”, “believe”, “plan”, “estimate”, “expect”, “intend”, “propose” and similar wording. Forward-looking statements involve known and unknown risks and uncertainties that could cause actual results, performance, or achievements to differ materially from those expressed or implied in this news release. Factors that could cause actual results to differ materially from those anticipated in this news release include, but are not limited to, the Company’s inability to timely execute on its business strategy and timely and successfully complete its clinical trials and studies, the Company’s inability to obtain the necessary regulatory approvals related to its activities, risks associated with its debt to Nuance Pharma and Nuance Pharma’s move to recognize the arbitral award in Ontario, risks associated with drug development generally and those risk factors set forth in the Company’s public filings made in Canada and available on sedarplus.com. The Company assumes no obligation to update the forward-looking statements or to update the reasons why actual results could differ from those reflected in the forward-looking statements except as required by applicable law.

View source version on businesswire.com: https://www.businesswire.com/news/home/20240401046957/en/

Antibe Therapeutics Inc.

Christina Cameron

VP Investor Relations

+1 416-577-1443

christina@antibethera.com

Source: Antibe Therapeutics Inc.

FAQ

Why was otenaproxesul placed on clinical hold by the FDA?

Otenaproxesul was placed on clinical hold by the FDA, delaying the initiation of the planned Phase II trial.

What legal action has Nuance Pharma taken against Antibe?

Nuance Pharma has initiated legal action seeking recognition and enforcement of an arbitration award in Ontario.

Who is part of the Executive Committee formed by Antibe?

The Executive Committee is composed of Robert E. Hoffman, Chair of the Board; Dan Legault, CEO; and Yung Wu, Member of the Board.

What impact could these recent developments have on Antibe's operations?

The recent developments may impact Antibe's operations, drug development timeline, and governance structure.