TheraCryf HY results – expanded pipeline, funded to end 2025

Half Year Report to 30 September 2024

Alderley Park, UK 28 November 2024. TheraCryf plc (AIM: TCF), the clinical stage drug development company focusing on oncology and neuropsychiatry, announces its unaudited interim results for the six months ended 30 September 2024.

Operational highlights

• Acquisition of Chronos Therapeutics Ltd (Chronos) in April 2024 added a late pre-clinical stage neuropsychiatry portfolio – integration now complete, Chronos is now a wholly owned subsidiary
• Placing, Subscription and Retail Offer in April 2024 raised gross proceeds of £0.9m, with directors and PDMRs investing c.10% of gross proceeds
• R&D Day in June 2024 presented extensive data on SFX-01 in models of glioblastoma (GBM) by colleagues from Erasmus Medical Centre, Rotterdam showing effectiveness of SFX-01 in these models, the third such observation in different academic centres

• Presentations also included data on acquired Chronos assets – DAT, an atypical dopamine reuptake inhibitor with potential utility in fatigue and narcolepsy; and OX-1,  an orexin-1 receptor antagonist with potential utility in addiction and anxiety disorders

• Publication of full paper on effectiveness of SFX-01 in models of childhood cancer rhabdomyosarcoma by collaborators at University La Sapienza, Rome in peer-reviewed journal BMC Cancer, confirming effects of SFX-01 as a radiosensitising agent as seen in models of glioblastoma

Post period

• Sudden passing of Chair of the Board and highly respected biotech executive, Dr Sue Foden, in November 2024
• Publication of full paper on SFX-01 Phase 1b healthy volunteer PK study published in peer reviewed journal Advances in Therapy in November 2024
• Amicable discussions continue with partner Stalicla SA on optimal design of the Phase 2 study in autism spectrum disorder and ongoing dispute
• European Patent Office decision to grant composition of matter patent for acquired Ox-1 antagonist in Europe – formal grant to be made on 18 December 2024

Financial highlights

• Financial performance in line with expectations:
  • Post-tax loss of £1.1m (2023: £1.5m)
  • Cash outflow from operations of £1.1m (2023: £1.3m)
  • Cash deposits, cash and cash equivalents balance on 30 September 2024 of £1.2m (30 September 2023: £3.7m)
• Cash runway unchanged to end of 2025 excluding any potential milestone payments.

Dr Huw Jones, Chief Executive Officer of TheraCryf, said:

“The first half of the year saw a transformation of the Company with the integration of the acquired Chronos assets, thus tripling the size of our R&D portfolio and expanding the potential opportunities for substantial monetisation. Planning for the atypical dopamine uptake inhibitor (DAT) and Orexin-1 antagonist programmes has also started in earnest. 

“We saw further data generated on lead asset SFX-01 by collaborators on our grant funded GBM programme from the Erasmus MC in Rotterdam – triangulating data published by two other collaborators and further de-risking the programme, showing different cell lines and tissues all responding to SFX-01 in independent laboratories with varying methodologies. Data demonstrating SFX-01’s effectiveness in radiosensitisation in rhabdomyosarcoma was also published in a prestigious cancer journal by our collaborators from University La Sapienza, Rome.

“Post period, data from our Phase 1b healthy volunteer PK study of SFX-01 was published in peer reviewed journal Advances in Therapy, showing the effectiveness of our new enteric coated tablet formation in proceeding beyond the acid environment of the stomach and releasing active drug where desired, in the small intestine. Concentrations of sulforaphane and metabolites were observed in the range where biological activity is seen in models of various diseases of interest.”

“Recently we have had a notification from the European Patent Office of an intention to grant a composition of matter patent for our acquired OX-1 antagonist asset in December 2024. This complements patents already granted in territories such as the USA.”

“In November, we were shocked and saddened at the sudden and unexpected death of our Chair Dr Sue Foden. Sue was highly supportive of management in the development and delivery of our plans and I re-iterate our deepest sympathies to her family and friends.”

“Despite the recent sad news, we are better positioned than ever to execute on our business model to generate compelling data sets and commercialise our assets via accretive industry collaborations.”

Dr Huw Jones, CEO, and Toni Hänninen, CFO will provide a live results presentation via the Investor Meet Company platform at 11am GMT on Thursday, 28 November 2024.