23 September 2022

Roquefort Therapeutics plc

("Roquefort Therapeutics" or the "Company")

Interim Results to 30 June 2022

Roquefort Therapeutics (LSE:ROQ, OTCQB:ROQAF), the Main Market listed biotech company focused on developing first in class drugs in the high value and high growth oncology segment, is pleased to present its interim results for the six-month period ended 30 June 2022 (the "period" or "H1").

Highlights

·      Collaborative work with Murdoch University, Western Australia to design and test a novel series of gene silencing reagents, antisense oligonucleotides, targeting Midkine

·      Positive pre-clinical trials results demonstrated that the Company's lead oligonucleotide drug candidates significantly reduce Midkine levels seen in human cancer cells

·      Portfolio review including the Midkine antibody programs to assess commercial potential

·      Midkine patent filed following positive pe-clinical in vitro trials

·      Significantly strengthened the Board with two highly experienced sector NED appointments, Jean Duvall and Simon Sinclair

·      Professor Trevor Jones appointment as advisor to the Board

·      Announced on 22 June 2022 a conditional share sale and purchase agreement with the shareholders of Oncogeni Limited ("Oncogeni"), a UK biotech company developing novel patented cancer medicines and a placing to raise £1 million at a price of 14p per share

·      Cash at period end of £3,328,573 and for the 6 months to 30 June 2022, net loss of £762,281

Post Period End Highlights

·      Completion of Oncogeni acquisition for £5.5 million, a successful £1 million fundraise and key board appointments:

o  Ajan Reginald as CEO and Professor Sir Martin Evans as Group Chief Scientific Officer, Darrin Disley as NED

·      Company has pivoted towards a material oncology business with four fully funded, novel, patent-protected pre-clinical anti-cancer medicines

·      Near-term clinical trial application and licensing opportunities from advanced stage of development of Midkine and siRNA products

·      State of the art facility located in Stratford-upon-Avon which has the infrastructure required for the pre-clinical development of the Group's portfolio of antibodies, oligonucleotides and cell and gene therapies

·      On 15 July 2022, the Company announced that trading in the Company's Ordinary Shares had commenced on the OTCQB Venture Market in the United States with the ticker: ROQAF

Outlook

·      Potential to drive significant value from our novel oncology programs

·      Management is targeting clinical readiness for one of its development programs during H2 2023

Chairman Statement 

I am pleased to present the interim financial statements to shareholders for the six months ending 30 June 2022.

The Company made encouraging progress with its pre-clinical program and on 17 January 2022 completed the first stage screening of a novel series of gene silencing reagents targeting Midkine, with the most promising lead drugs selected. The lead compounds were synthesised in preparation for in vitro experiments to test efficacy in altering cancer cell properties. This is a first-in-class drug target with significant clinical potential and we believe the targeted delivery of Midkine inhibiting RNA therapeutic drugs to tumours represents a novel anti-cancer treatment strategy.

Following the positive pre-clinical trials, the Company announced on 21 March 2022 that it had filed its first composition of matter provisional patent application for a new class of RNA therapeutic drugs targeting Midkine. The in vitro experiments generated very positive results demonstrating that the Company's lead oligonucleotide drug candidates significantly reduce Midkine levels seen in human cancer cells.

In order to drive the Company further towards commercialisation, Roquefort Therapeutics strengthened the team with three appointments from the pharmaceutical industry, each of whom add significant relevant expertise in drug development, commercialising programs and driving pre-clinical and clinical programs. As such, I'd like to again welcome Professor Trevor Jones, as strategic and scientific advisor to the Board who joined the Company on 14 February 2022, and Ms Jean Duvall and Dr Simon Sinclair as Non-Executive Directors, who joined on 5 April and 20 April 2022, respectively. All three appointments will help further the Company's ability to capitalise on the significant growth potential that Midkine inhibiting drugs offer.

The collaboration with Murdoch University continued to yield encouraging results with the Company's lead oligonucleotide drug candidates. In addition, following a review of the wider portfolio acquired with Lyramid, it resulted in the conclusion that two of the antibody programs have high commercial potential and we will therefore be accelerating development of those as we aim to be the first to market with an anti-Midkine oncology antibody. These developments broaden the commercial potential within the Company and enhance the upside value that we believe can be delivered as we progress the programs.

On 22 June 2022, Roquefort Therapeutics announced that it had entered into a conditional share sale and purchase agreement with Oncogeni Ltd, a UK biotech company developing novel patented cancer medicines, pursuant to which Roquefort Therapeutics had agreed to acquire the entire issued share capital of Oncogeni for an aggregate consideration to be satisfied by the issue of 50,000,000 new ordinary shares in the Company.  I am pleased to say that following the publication of a prospectus, the acquisition completed on 16 September 2022.

Post Period End

On 16 September 2022, we completed the fundraise and the acquisition of Oncogeni, which pivots Roquefort Therapeutics into a material oncology biotech company with a pre-clinical anti-cancer portfolio that is patent protected and fully funded to clinical trial submission.

The Roquefort Therapeutics portfolio consists of four fully funded, novel, patent-protected pre-clinical anti-cancer medicines.  The highly complementary profile of four best-in-class medicines consists of:

•     Midkine antibodies with significant in vivo efficacy and toxicology studies;

•     Midkine RNA therapeutics with novel anti-cancer gene editing action;

•     Mesodermal Killer (MK) cells, are a new class of cellular medicine engineered to kill cancer both directly and by enhancing the activity of Natural Killer cells; and

•     Novel siRNAs (small interfering RNA) inhibit STAT-6, to kill solid tumours. 

The Company now has the potential to meet significant value inflection with the average valuation of biotech companies with a single lead asset completing pre-clinical development being circa US$71 million (£55 million, 2005-2020)[1]. In that context, now that Roquefort Therapeutics has four lead assets, we believe the Company and its IP represents a highly compelling value proposition. 

In addition to the expanded portfolio, Roquefort Therapeutics now has a state-of-the-art laboratory and manufacturing facility which provides the Group with major cost saving and time advantages as we progress through the pre-clinical stage of development. In addition, the acquisition strengthens our Board and senior management team with complementary skills and expertise, and I am very excited with the team we have in place to drive our programs forward and to realise value.

We further strengthened the Roquefort Therapeutics senior team by welcoming Ajan Reginald as CEO, Professor Sir Martin Evans as Group Chief Scientific Officer and Dr Darrin Disley as NED to the Board of Roquefort Therapeutics, and Professor Armand Keating as Roquefort Therapeutics' new independent Chief Medical Advisor. Sir Martin Evans, a Nobel Prize winning scientist for his work in embryonic stem cells and DNA research will be incredibly valuable as Group Chief Scientific Officer throughout our preclinical studies. Ajan Reginald's experience in commercialisation both within big pharma and in biotech will be invaluable as we look to achieve value in this high growth segment of life sciences.  Dr Darrin Disley is a great addition as Non-Executive Director, and his expertise in fundraising and value creation is incredibly complementary to our existing Board of Directors. Professor Keating is a renowned expert in anti-cancer cell therapy, a key area of Roquefort Therapeutics' research and is a welcome addition as Chief Medical Advisor.  The quality and industry standing of the team assembled reflects the opportunity of the science being progressed by Roquefort Therapeutics.

Outlook

Roquefort Therapeutics has achieved a great deal in the reporting period, as demonstrated by the significant progress made with our oligonucleotide Midkine programs and following a review of the wider Lyramid portfolio we concluded that two of the antibody programs have high commercial potential and we will therefore be accelerating development in that area.  Following the acquisition of Oncogeni, we are a material oncology focused biotech business. It is very rare for a company of our size and valuation to have four substantial anti-cancer pre-clinical assets, and we have the potential to drive significant value from our novel oncology programs. We aim to have one program clinic ready during H2 2023, as we are now better placed with Oncogeni to complete the value milestone of IND / CTA filings. The team we have in place now is truly world class, with a proven track record in drug development which will help drive innovation and ultimately value in our portfolio of oncology drugs, and I am confident in the prospects of Roquefort Therapeutics.  I look forward to providing shareholders with progress of our programs over the next few months.   Finally I would like to thank shareholders for their continued support of Roquefort Therapeutics and to welcome new shareholders.

Financial Review

For the 6 months to 30 June 2022, the Group reported a net loss of £762,281, mostly relating to administrative expenses. The Group maintained a strong balance sheet position at 30 June 2022, most notably holding cash at period end of £3,328,573.

Directors

The following directors have held office during the period to 30 June 2022:

Mr Stephen West, Executive Chairman

Dr Michael Stein, Non-Executive Director

Mr Simon Sinclair, Non-Executive Director (appointed 20 April 2022)

Ms Jean Duvall, Non-Executive Director (appointed 5 April 2022)

Mr Mark Freeman, Non-Executive Director (resigned 16 September 2022)

Mr Mark Rollins, Non-Executive Director (resigned 4 April 2022)            

Corporate Governance

The UK Corporate Governance Code (September 2014) ("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 2022 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 2022 and that have materially affected the financial position of the performance of the business during that period.

ENDS

Enquiries:

LEI: ‎254900P4SISIWOR9RH34