Crism Therapeutics Corporation (AIM:CRTX) Crism Therapeutics shares rose 5.0% to 10.5p after the company disclosed FDA Orphan Drug Designation for its irinotecan-ChemoSeed programme and an £896,088 Innovate UK Biomedical Catalyst grant.
Cash stood at £1.13 million at year end against total assets of £1.79 million, with the company having raised approximately £4.7 million through equity placings and retail offers between June 2025 and June 2026 to fund trial setup and initial patient dosing.
The headline regulatory achievement of the period was MHRA Clinical Trial Authorisation, received in August 2025, clearing Crism to begin an open-label, registration-grade Phase 2 study of irinotecan-ChemoSeed in surgically resectable glioblastoma.
Since the period end, the company secured FDA Orphan Drug Designation for the same programme in March 2026, unlocking potential seven-year US market exclusivity, tax credits and fee waivers, and received a £896,088 Innovate UK Biomedical Catalyst grant covering 70% of Part 1 trial costs, alongside a £99,902 Invest Northern Ireland grant for its docetaxel-ChemoSeed prostate cancer programme.
A Site Initiation Visit for the Phase 2 trial is planned for late July 2026, with first patient dosing targeted as soon as practicable thereafter.
"Securing MHRA authorisation to initiate our Phase 2 clinical trial was a key milestone, providing validation that ChemoSeed is ready to be evaluated as a potential new standard of care for glioblastoma patients," said Executive Chairman Andrew Webb.