REG - Roquefort Theraptcs. - Clinical Trial & License Agreement Update

Roquefort TherapeuticsAnnouncement

12/12/2025 07:00

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RNS Number : 2919L  Roquefort Therapeutics PLC  12 December 2025

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:
 
 Roquefort Therapeutics plc                                 +44 (0)20 3918 8633
 Stephen West (Chairman) / Dr Darrin Disley (Interim MD)
 SP Angel Corporate Finance LLP (Broker to the Company)     +44 (0)20 3470 0470

 David Hignell / Vadim Alexandre / Devik Mehta
 Shard Capital Partners LLP (Broker to the Company)         +44 (0)20 4530 6926

 Damon Heath
 CPS Capital Group (Broker to A2A Pharma & Coiled USA)      +61 (0)8 9223 2222

 Jason Peterson / David Valentino
 Burson Buchanan (Public Relations)                         +44 (0)20 7466 5000

 Ben Romney / Jamie Hooper

 

LEI: ‎254900P4SISIWOR9RH34

 

For further information on Roquefort Therapeutics,
please visit www.roquefortplc.com (http://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/ (https://www.a2apharma.com/)

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