THERACRYF PLC Operational summary
Substantial out-licensing deal signed with
Up to
Phase I/Ib healthy volunteer study of new SFX-01 formulation completed during the financial year: Positive safety and pharmacokinetic read out announced on
No serious adverse events, total drug and active metabolites detected in the range seen in lab experiments which show significant activity in vitro
First phase of glioblastoma trial expected to commence in 2024 and to be conducted as an Investigator Sponsored Study at the
Grant applications submitted to
Further progress with the
Continued collaboration with University La
Emerging evidence of radio-sensitisation demonstrated for SFX-01 in vitro, as published at ESMO rare diseases conference,
Continued collaboration with
CFO,
Outlook
Clinical trials in Autism Spectrum Disorder and Glioblastoma scheduled to commence by partners within the next twelve months
Full data set from Phase I/Ib healthy volunteer study available in Q2/Q3 2023
Data from breast cancer, colorectal cancer and radio-sensitisation pre-clinical work expected by end of 2023
Further milestones from STALICLA collaboration expected during the year with up to
Financial highlights
Financial performance in-line with expectations
Post tax loss of
Cash outflow from operations of
Cash and short-term investments and cash on deposit at
Dr
Our new commercial scale formulation of SFX-01 has performed well in our Phase 1b healthy volunteer study, showing release commensurate with the enteric coat, absence of SAEs and total active and active metabolite levels in the range seen in vitro where substantial biological activity was observed.
In our pre-clinical collaborations, we were pleased to see evidence of radio-sensitisation by SFX-01 in a further tumour type (rhabdomyosarcoma), complementing results seen previously in models of glioblastoma. The coming year promises even more evaluation of SFX-01 in the clinic and the receipt of substantial milestone payments, positioning us well to continue to progress our programmes at all levels.
On a personal note, I would like to express my sincere thanks to our CFO Richard who is retiring at the AGM. His steadfast support and well considered judgements have been invaluable both to the Company and to me personally. I wish him and his family the very best as they enjoy considerably more leisure time that will no doubt fill up very quickly.'
Contact:
Tel: +44 207 457 2020
Email: enquiries@evgen.com
About
The Company's lead asset, SFX-01, is a patented composition of synthetic sulforaphane and alpha-cyclodextrin and has undergone clinical trials for oestrogen-positive (ER+) metastatic breast cancer and recently a Phase 1b study of the Company's new enteric coated tablet formulation. The FDA has granted Orphan Drug status to SFX-01 in malignant glioma. SFX-01 will be investigated initially in this indication as an investigator sponsored study in
The Company also has a wide number of collaborations with leading academic centres in the
The Company has its headquarters and registered office at
(C) 2023 Electronic News Publishing, source
