Evgen Pharma PLC (LON:EVG) said it is building “an exciting and valuable business” with a strengthened senior team and its partner Juvenescence progressing well towards market launch within two years.
The firm completed its first out-licensing deal with Juvenescence for use of Sulforadex technology in non-pharmaceutical markets, which will earn it up to US$10.5mln receivable in milestones with royalties on sales, expected from mid-2023.
READ: Evgen Pharma announces progress on two separate cancer programmes
The group is progressing with a Phase IIb/III trial for its candidate SFX-01 in acute respiratory distress syndrome, including COVID-19 patients, with 133 patients recruited to date.
The study is sponsored by the University of Dundee and NHS Tayside and has received grant funding from LifeArc.
A safety data review by the independent Data Monitoring Committee of 60 randomised patients concluded there were no concerns regarding patient safety.
Further assessment of unblinded data from 100 randomised patients for safety and futility will be performed imminently, the clinical stage drug development company said.
The group is also preparing a randomised, blinded Phase I/II clinical trial to start in the first half next year, studying SFX-01 in brain cancer.
In vitro data suggests that SFX-01 may also suppress tumour growth in patients with a certain type of breast cancer who have become resistant to standard of care such as palbociclib (sold as Ibrance by Pfizer).
Other in vitro data showed that SFX-01 may also be effective in treating blood cancers such as the severe form of childhood leukaemia, juvenile myelomonocytic leukaemia.
Results for the year ending 31 March were in line with expectations, with post-tax loss remaining flat at £2.7mln, cash outflow from operations rising to £2.9mln from £2.6mln last year and cash at period-end of £11.6mln.
“Over the last 12 months Evgen has substantially strengthened its senior team, made considerable progress across all areas of its business, raised significant funding to accelerate the development of its therapeutic programmes and concluded its first commercial partnership,” said chairman Barry Clare in a release.
Shares rose 4% to 8p on Tuesday morning.