RedHill Biopharma Terminates T-Cure Bio Agreement

TL;DR

RedHill ditches T-Cure on RHB-107 deal over missed payments and development.

AI Summary

RedHill Biopharma Ltd. announced on July 9, 2024, the termination of its agreement with T-Cure Bio Ltd. for the development of RHB-107 (Opaganib). This termination is due to T-Cure Bio's failure to meet certain conditions, including the payment of an upfront fee and the initiation of clinical development activities.

Why It Matters

This termination signifies a setback in the development of RHB-107, potentially impacting RedHill's pipeline and future revenue streams.

Risk Assessment

Risk Level: medium — The termination of a development agreement indicates potential issues with the drug's progress or partnership, which could affect the company's financial and operational outlook.

Key Players & Entities

• RedHill Biopharma Ltd. (company) — Registrant
• T-Cure Bio Ltd. (company) — Partner in development agreement
• RHB-107 (Opaganib) (drug) — Drug under development
• July 9, 2024 (date) — Date of announcement

FAQ

Filing Documents

• zk2431650.htm (6-K) — 24KB
• image00001.jpg (GRAPHIC) — 308KB
• 0001178913-24-002158.txt ( ) — 450KB

SIGNATURES

SIGNATURES Pursuant to the requirements of the Securities Exchange Act of 1934, the Registrant has duly caused this report to be signed on its behalf by the undersigned, thereunto duly authorized. REDHILL BIOPHARMA LTD. (the "Registrant") Date: July 9, 2024 By: /s/ Dror Ben-Asher Name: Dror Ben-Asher Title: Chief Executive Officer Press Release RedHill Biopharma Terminates License Agreement for Aemcolo TEL-AVIV, Israel / RALEIGH, NC, July 9, 2024 /PRNewswire/ -- RedHill Biopharma Ltd. (Nasdaq: RDHL) ("RedHill" or the "Company"), a specialty biopharmaceutical company, today announced the mutual decision with Cosmo Technologies Ltd. ("Cosmo") to voluntary terminate their exclusive U.S. license agreement for Aemcolo, a treatment for traveler's diarrhea (the "License Agreement"). The License Agreement, initially dated October 17, 2019, will be officially terminated on October 8, 2024. Per the terms of the License Agreement, RedHill will immediately cease any Aemcolo commercialization of Aemcolo upon termination of the License Agreement, at which point all rights previously ascribed in the License Agreement to RedHill will revert to Cosmo. Rick Scruggs, RedHill's Chief Commercial Officer, said : "This decision to stop the commercialization of Aemcolo was made following careful mutual consideration and we would like to offer our sincere thanks to the Cosmo team for their partnership over the past years." About RedHill Biopharma RedHill Biopharma Ltd. (Nasdaq: RDHL) is a specialty biopharmaceutical company primarily focused on gastrointestinal and infectious diseases. RedHill promotes the gastrointestinal drugs Talicia , for the treatment of Helicobacter pylori (H. pylori) infection in adults 1 , and Aemcolo , for the treatment of travelers' diarrhea in adults 2 . RedHill's key clinical late-stage development programs include: (i) opaganib (ABC294640) , a first - in - class oral broad-acting, host-directed SPHK2 selective inhibitor with potential for pan

Forward Looking Statements

Forward Looking Statements This press release contains "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995 and may discuss investment opportunities, stock analysis, financial performance, investor relations, and market trends. Such statements, including, but not limited to, statements regarding the intended use of net proceeds from the offering, may be preceded by the words "intends," "may," "will," "plans," "expects," "anticipates," "projects," "predicts," "estimates," "aims," "believes," "hopes," "potential" or similar words and include statements regarding the risk that the Company will not comply with the listing requirements of the Nasdaq Capital Market ("Nasdaq") to remain listed for trading on Nasdaq, the addition of new revenue generating products, out-licensing of the Company's development pipeline assets, timing of opaganib's development for Acute Radiation Syndrome, non-dilutive development funding from RHB-107 and its inclusion in a key platform study. Forward-looking statements are based on certain assumptions and are subject to various known and unknown risks and uncertainties, many of which are beyond the Company's control and cannot be predicted or quantified, and consequently, actual results may differ materially from those expressed or implied by such forward-looking statements. Such risks and uncertainties include, without limitation, market and other conditions, the risk that the addition of new revenue generating products or out-licensing transactions will not occur; the risk that acceptance onto the RNCP Product Development Pipeline will not guarantee ongoing development or that any such development will not be completed or successful; the risk that the FDA does not agree with the Company's proposed development plans for opaganib for any indication, the risk that observations from preclinical studies are not indicative or predictive of results in clinical trials; the risk that the FDA pre-stu

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