Roquefort Thera Regulatory News (ROQ)

12 December 2025

Roquefort Therapeutics plc

("Roquefort Therapeutics" or the "Company")

Clinical Trial & License Agreement Update

Roquefort Therapeutics plc (LSE:ROQ), the Main Market listed biotech company, announces that the binding exclusive license agreement with Coiled Therapeutics, Inc. ("Coiled USA") and A2A Pharmaceuticals, Inc. ("A2A Pharma") regarding the worldwide exclusive rights to AO-252 (the "AO-252 License Agreement") announced on 18 November 2025 has been amended and includes an extension to the long stop date from 31 January 2026 to 16 March 2026. In addition, the Company provides an update on the progress of the Phase I clinical trial which is currently underway in USA.

Clinical Stage Progress

Coiled USA recently received approval for a protocol amendment to expand the inclusion criteria for its Phase I clinical trial for AO-252 to encompass all solid tumours, including patients with or without brain metastases.

Following this successful protocol amendment, together with encouraging safety signals, Coiled USA has strategically prioritised prostate cancer as its primary indication for clinical trials, with the first patient with metastatic castration-resistant prostate cancer being enrolled and dosed in November 2025 within the active Cohort 4b dose level.

The decision by Coiled USA to prioritise prostate cancer as its primary indication for clinical trials is supported by positive feedback from potential pharmaceutical partners and investors, and is also underpinned by compelling pre-clinical data across multiple distinct models:

· VCaP Xenografts (AR-positive, ETS-fusion): demonstrated 100% complete response/partial response ("CR+PR") with complete regressions observed;

· AR-independent Cell Lines: significant tumour growth inhibition ("TGI") of 60% was observed in androgen receptor ("AR") independent models;

· 22Rv1 Models (AR-resistant): demonstrated 90% TGI; and

· Mechanism: importantly, efficacy was observed to be independent of androgen signalling, suggesting broad potential utility in resistant disease.

Coiled USA is currently enrolling additional patients in Cohort 4b, the best of six cohort dose levels where the strongest clinical benefit has been observed to date. In addition, Coiled USA has initiated a food effect cohort study using the Cohort 4b dose to optimise exposure based on clear PK/PD modelling.

The commercial interest in oral targeted therapies for multiple types of solid tumours, including prostate cancer, was recently demonstrated by the announcement on 17 November 2025 by Johnson & Johnson that it was acquiring Halda Therapeutics OpCo, Inc ("Halda") for US$3.05 billion in cash. Prior to the acquisition, Halda's Phase I/II clinical trial had demonstrated impressive preliminary efficacy and a strong early safety profile in prostate cancer.

License Extension

Completion of the AO-252 License Agreement is conditional on inter alia the Company's enlarged ordinary share capital being admitted to trading on the AIM market ("Admission") no later than 31 January 2026 (the "Longstop Date"). The Company and its advisers are currently progressing key documents relating to the Transaction (defined below), including an AIM Admission Document which will be published in due course. 

Due to the impact of the forthcoming holiday season, it is unlikely that Admission will occur prior to 31 January 2026 and therefore the parties to the AO-252 License Agreement have agreed to extend the Longstop Date to 16 March 2026 in return for an amendment to certain commercial terms (refer below). The extension to the Longstop Date will also provide additional time for data readouts from the clinical trial.

Amendment to Commercial Terms

In return for agreeing to extend the Longstop Date, the parties to the AO-252 License Agreement have agreed to amend the following commercial terms in the agreement:

1. The upfront consideration amount has been increased to £31,875,000 to be satisfied by the issue of ordinary shares in the capital of the Company ("Ordinary Shares") to the shareholders of Coiled USA (the "Consideration Shares") at an effective price of 1.7 pence per share, subject to the satisfaction of certain conditions, including Admission (the "Transaction");

2. The total number of additional Ordinary Shares to be issued to A2A Pharma should certain market capitalisation targets be met for a period of 30 consecutive days (the "Deferred Consideration Shares") has been amended to the following:

a. Market capitalisation of the Company being greater than or equal to £60 million: 250 million Deferred Consideration Shares;

b. Market capitalisation of the Company being greater than or equal to £90 million: a further 250 million Deferred Consideration Shares; and

c. Market capitalisation of the Company being greater than or equal to £120 million: a further 250 million Deferred Consideration Shares.

The Board believes that the modest increase in the number of Consideration Shares and Deferred Consideration Shares is justified given the significant progress Coiled USA has made with the current Phase I clinical trial.

Stephen West, Roquefort Therapeutics Chairman commented:

"We are pleased with Coiled USA's strategic decision to prioritise prostate cancer as the primary indication for AO-252, a move that is supported by both compelling pre-clinical data and positive feedback from potential pharmaceutical partners and investors. This pivot, combined with the enrolment of the first prostate cancer patient in Cohort 4b, represents an exciting move for the Transaction. The recent acquisition of Halda Therapeutics by Johnson & Johnson shows the significant commercial appetite for novel oral therapies in prostate cancer and underscores the potential value that could be unlocked through our Transaction. With clear market validation and encouraging early clinical signals, we believe we are well positioned to deliver value for our shareholders."

Dr Sridhar Vempati, proposed CEO post Admission commented:

"Dosing the first prostate cancer patients in Cohort 4b marks a major clinical and scientific step forward. The dose-escalation work has identified this cohort as the level where we see the most meaningful activity, including tumour reduction. Given the specific properties of AO-252, we see a clear opportunity to further optimise exposure through the upcoming food effect study. This targeted approach ensures we are maximising the drug's bioavailability as we advance the program. Extending the closing deadline for our Transaction to 16 March 2026 reflects our shared confidence in delivering significant value from the AO-252 program."

Regulatory Information

This Announcement contains inside information for the purposes of the UK version of the market abuse regulation (EU No. 596/2014) as it forms part of United Kingdom domestic law by virtue of the European Union (Withdrawal) Act 2018 ("UK MAR").

ENDS

Enquiries:

LEI: ‎254900P4SISIWOR9RH34

For further information on Roquefort Therapeutics, please visit www.roquefortplc.com 

About Coiled USA

Coiled USA is a clinical stage oncology company and is a spin-out of A2A Pharmaceuticals, Inc. Coiled USA holds the exclusive worldwide rights to AO-252, a novel, brain-penetrant small molecule inhibitor designed to disrupt TACC3 protein-protein interactions.  Coiled USA has advanced the AO-252 program through pre-clinical development and IND approval and commenced Phase I trials in the USA (trials ID: NCT06136884). Coiled USA is actively enrolling patients to test for safety and efficacy in patients whose cancer has progressed on other treatments.

About A2A Pharmaceuticals

A2A Pharmaceuticals is a private, well-funded company that uses proprietary computational systems, including generative AI with its SCULPT™ platform to accelerate the development of novel drug alternatives for life threatening diseases like cancer. This enables a more efficient process than traditional trial and error approaches to drug discovery. 

A2A Pharmaceuticals aims to develop therapies to early clinical stages and then spin them out into standalone entities to progress them through clinical development. In 2018, A2A Pharmaceuticals spun out its MLL-Menin program to Biomea Fusion, Inc. ("Biomea Fusion"), a company that completed an IPO on Nasdaq in 2021 raising US$153 million and listing with a market capitalisation of US$464 million. Post-IPO Biomea Fusion's market capitalisation reached a peak of over US$1 billion.

Further information on A2A Pharmaceuticals can be found at: https://www.a2apharma.com/