Interim Results to 30 June 2025

30 September 2025

Roquefort Therapeutics plc

("Roquefort Therapeutics" or the "Company")

Interim Results to 30 June 2025

Roquefort Therapeutics (LSE:ROQ), the Main Market listed biotech company announces its interim results for the six-month period ended 30 June 2025 (the "period" or "H1").

Highlights

·      The Company announced its intention to pivot away from its existing focus on pre-clinical assets to more mature clinical stage assets

·      Signed binding share purchase agreement with Pleiades Pharma Limited ("Pleiades Pharma") for the proposed sale of Lyramid Pty Ltd ("Lyramid") for a consideration of $10.8 million

o  Long stop date of the transaction to complete is 31 October 2025

·      Signed term sheet with The Nation Trust Holding LLC ("Nation Trust") for the sale of Oncogeni Ltd ("Oncogeni") for a consideration cash amount of up to US$12 million consisting of upfront and milestone payments

·      Raised £236,000 by way of a private placement with the proceeds being for general working capital purposes as the Company continued to work towards completion of the Lyramid and Oncogeni transactions

·      Ajan Reginald resigned as CEO, Prof. Sir Martin Evans resigned as Non-Executive Director and Dr Darrin M Disley OBE, a Non-Executive Director, was appointed Interim Managing Director in March 2025

·      Cash at period end of £182,923 and a net loss of £467,167 for the 6 months to 30 June 2025

Post Period End Highlights

·      In line with the Company's new strategy of focusing on more mature clinical stage assets, the Company announced the proposed acquisition (the "Transaction") of Coiled Therapeutics, Inc. ("Coiled USA"), a clinical stage oncology company, currently in a Phase I trial for its AO-252 therapy in the USA (trials ID: NCT06136884) in advanced solid tumours and is showing encouraging efficacy, responses, and clinical benefit with a benign safety profile

o  Term sheet is binding with exclusivity until 31 January 2026 and may only be cancelled early upon payment of a termination fee of US$1 million

o  Upon completion of the Transaction it is proposed that the name of the Company be changed to Coiled Therapeutics plc

·      Coiled USA has expressed interest in advancing the STAT-6 program into clinical trials, and accordingly the Company has terminated discussions with Nation Trust for the sale of Oncogeni

·      As previously announced the Company intends to transfer ownership of its wholly owned subsidiary Lyramid to the Company's underlying shareholders so the Company's existing shareholders benefit from the Pleiades Pharma sale

·      The Company has the option to carve out the MK Cell therapy prior to completion of the Transaction

Outlook

·      The principal focus of the Company is to deliver on the new strategy of targeting clinical stage assets by completing the proposed acquisition of Coiled USA

·      The primary focus of the enlarged entity (to be renamed Coiled Therapeutics plc) will be on advancing clinical trials for the AO-252 therapy:

o  Early Phase I data on AO-252 is very encouraging, and we believe it could be a promising alternative for helping patients with a variety of cancers

o  Plan to start dose expansion studies in Q4 2025 and enrol a sufficient number of patients in 2026 to plan for Phase III registrational trials

·      In addition, the Company plans to advance STAT-6 through IND and prepare for clinical trials

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").

Commenting on the Interim Results, Roquefort Therapeutics Chairman, Stephen West said:

"During the period Roquefort Therapeutics announced a new strategic direction to refocus from pre-clinical assets towards clinical stage assets with a clearer path towards value creation and we are pleased to have identified Coiled Therapeutics from A2A Pharmaceuticals as our transformational acquisition.  Our focus for the remainder of the year is to complete the proposed acquisition of Coiled Therapeutics, which will potentially set the Company up with two clinical stage assets: AO-252 an STAT-6.  We will keep shareholders updated as to its progress and I would like to thank them for their ongoing support."

Enquiries:

LEI: ‎254900P4SISIWOR9RH34

Chairman Statement 

I am pleased to present the interim financial statements to shareholders for the six months ended 30 June 2025.   This was a busy period for Roquefort Therapeutics as the Company sought to extract value from its pre-clinical portfolio and pivot its focus to more mature clinical stage assets.

We started the period by announcing the proposed sale of Lyramid to Pleiades Pharma.  In February the Company signed a binding share purchase agreement  for the sale of Lyramid to Pleiades Pharma for a consideration amount of US$10.8 million.  The consideration amount includes the potential of an upfront cash payment and equity in Pleiades Pharma and is contingent on Pleiades Pharma completing a fundraising round.   The long stop date for the sale of Lyramid to complete is 31 October 2025.   In addition, in March 2025, we announced the signing of a term sheet for the proposed sale of our wholly owned subsidiary Oncogeni Ltd ("Oncogeni") to The Nation Trust Holding LLC ("Nation Trust") for a consideration cash amount of up to US$12 million.  The cash consideration of $12 million consisted of upfront and milestone payments.

The Company also announced in March 2025, changes to the leadership and Board with Ajan Reginald resigning as CEO and Director of the Company and Prof. Sir Martin Evans resigning as Non-Executive Director.  We appointed seasoned life sciences entrepreneur, Dr Darrin M Disley OBE a Non-Executive Director, as Interim Managing Director to help take the business forward.

The Company continues to operate at a reduced cost base and, in order to improve general working capital, raised £236,000 by way of a private placing of 15,733,333 new ordinary shares in the capital of the Company in March 2025.

Post Period End

In August the Company announced a new long stop date of 31 October 2025 in order to enable the Lyramid sale to Pleiades Pharma to complete.  Given this development a new equity holding company was incorporated (Midkine Investments Ltd) to hold the Pleiades Pharma consideration shares. It is the intention of the Company to effectively carve out the Pleiades Pharma consideration shares for the benefit of existing Roquefort Therapeutics shareholders and convertible noteholders. 

Proposed Coiled Therapeutics Acquisition

On 8 September 2025 Roquefort Therapeutics announced it had entered into heads of terms ("Term Sheet") for the proposed acquisition of Coiled Therapeutics, Inc. ("Coiled USA") which is a clinical stage oncology company via a reverse takeover.  The Company believes this is a fantastic opportunity to pivot Roquefort Therapeutics from being a pre-clinical company into a clinical stage company creating a clear path to value inflection.  Coiled USA is a spin-out of A2A Pharmaceuticals, Inc. ("A2A Pharmaceuticals"). A2A Pharmaceuticals uses proprietary computational systems, including generative AI with its SCULPT™ platform to accelerate the development of novel drug alternatives.  Coiled USA, through A2A Pharmaceuticals, holds the exclusive worldwide rights to AO-252, a novel, brain-penetrant small molecule inhibitor designed to disrupt TACC3 protein-protein interactions.    

In preclinical studies, AO-252 demonstrated complete tumour regression as a standalone treatment in models of ovarian, triple-negative breast, endometrial, gastric, and prostate cancers and proved effective against cancers that had spread to the brain.  AO-252 has now entered Phase I human trials in the USA and early results are encouraging, with the drug showing a strong safety profile and delivering clinical benefits for patients even at low doses.  Coiled USA is actively enrolling patients for the trial, which is being expanded to include all solid tumours. Based on its unique biomarker, AO-252 has the potential to become a new treatment for as many as 350,000 cancer patients annually in the US and EU. 

Additionally, A2A Pharmaceuticals and Coiled USA have confirmed interest in the Company's STAT-6 program and will aim to progress the program through IND into Phase I clinical trials. Given the interest in taking the STAT-6 program into clinical trials, discussions with Nation Trust for the sale of Oncogeni have ceased. As detailed above, Roquefort Therapeutics intends to transfer ownership of its wholly owned subsidiary Lyramid from Roquefort Therapeutics to the Company's underlying shareholders, via its new subsidiary Midkine Investments Ltd, so that the Company's existing shareholders will benefit from the proposed sale of Pleiades Pharma. Roquefort Therapeutics will also have the option to carve out the MK Cell therapy prior to completion of the Transaction.  As part of the Transaction, A2A Pharmaceuticals and its investors are committed to providing the majority of the funding requirement of the enlarged company over the next two years with an investment of £6 million.  Furthermore, the Company is excited by the strategic partnership with A2A Pharmaceuticals and will look to leverage its machine learning capabilities to help drive superior clinical outcomes and potentially produce novel candidates to enhance the pipeline.

The acquisition of Coiled USA is for an upfront consideration of £30 million, payable in shares.  Upon completion, the Company will be renamed Coiled Therapeutics plc and will seek admission to the AIM Market of the London Stock Exchange, cancelling its current listing on the London Stock Exchange's Main Market.   The transaction is subject to satisfactory due diligence and re-admission, with the Term Sheet remaining exclusive until 31 January 2026 and may only be cancelled early upon payment of a US$1 million termination fee. Shareholders should be aware that the transaction is not guaranteed to proceed, and its terms may change pending the outcome of due diligence. Further updates will be provided in due course.

The Directors of Roquefort Therapeutics believe this to be a value-enhancing transaction for shareholders which will pivot the Company into a clinical-stage biotech which aligns with our strategy to advance from pre-clinical to more developed assets. 

Outlook

The principal focus of the Company is to realise our new strategy which is to target clinical stage assets by completing the proposed acquisition of Coiled USA.  We believe it is an excellent opportunity to pivot Roquefort Therapeutics into a clinical stage company which has a clearer runway to value inflection milestones.  The early Phase I data on AO-252 is very encouraging, and we believe it could be a promising alternative for helping patients with a variety of cancers. Additionally, we are encouraged by the interest A2A Pharmaceuticals has shown in our STAT-6 program. Should the transaction complete, the Company could have two programs in human clinical trials, which represents considerable strategic progress. The Board views the future with optimism and would like to thank Roquefort Therapeutics shareholders for their continued support during the period.

Financial Review

For the 6 months to 30 June 2025, the Group reported a net loss of £467,167, mostly relating to administrative expenses. The Group maintained a sufficient balance sheet position at 30 June 2025 most notably holding cash at period end of £182,923.

Directors

The following directors have held office during the period to 30 June 2025:

Stephen West

Dr Darrin Disley

Ms Jean Duvall

Dr Simon Sinclair

Trevor Ajanthan (Ajan) Reginald (resigned 17 March 2025)

Prof. Sir Martin Evans (resigned 17 March 2025)

Corporate Governance

The UK Corporate Governance Code 2024 ("the Code"), as appended to the Listing Rules, sets out the Principles of Good Corporate Governance and Code Provisions which are applicable to listed companies incorporated in the United Kingdom. As a standard listed company, the Company is not subject to the Code; however, the Board acknowledges the importance of high standards of corporate governance and endeavours, given the Company's size and the constitution of the Board, to comply with the principles set out in the QCA Corporate Governance Code. The QCA Code sets out a standard of minimum best practice for small and mid-size quoted companies.

Responsibility Statement

The Directors are responsible for preparing the Unaudited Interim Condensed Financial Statements in accordance with the Disclosure and Transparency Rules of the United Kingdom's Financial Conduct Authority ("DTR") and with International Accounting Standard 34 on Interim Reporting ("IAS 34"). The Directors confirm that, to the best of their knowledge, this condensed interim report has been prepared in accordance with IAS 34 as adopted by the European Union. The interim management report includes a fair review of the information required by DTR 4.2.7 and DTR 4.2.8, namely:

•      an indication of important events that have occurred during the six months ended 30 June 2025 and their impact on the condensed financial statements for the period, and a description of the principal risks and uncertainties for the remaining six months of the financial year; and

•      related party transactions that have taken place in the six months ended 30 June 2025 and that have materially affected the financial position of the performance of the business during that period.