Submission of CTA Application

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1 July 2025

CRISM Therapeutics Corporation

("CRISM", "CRISM Therapeutics" or the "Company")

Submission of Clinical Trial Authorisation application to the MHRA

First-in-human clinical trial of a novel treatment for brain tumours

CRISM Therapeutics Corporation (AIM: CRTX), the innovative UK drug delivery company focused on the localised delivery of chemotherapy drugs, today confirms the submission of a Clinical Trial Authorisation ("CTA") application on 30 June 2025 to the UK Medicines and Healthcare products Regulatory Agency ("MHRA") for the Company's Phase 2 registration grade clinical study of irinotecan ChemoSeed in resectable glioblastoma.

The study, titled Open-label Phase 2 Safety and Efficacy Trial of Irinotecan ChemoSeed Administered Directly into the Resection Margin in Patients with Surgically Resectable Glioblastoma, is designed to evaluate the safety, tolerability, and efficacy of ChemoSeed, CRISM's proprietary biodegradable implant technology, delivering irinotecan directly into the resection margin following surgical removal of glioblastoma tumours.

The Phase 2 trial will enrol patients with both recurrent and newly diagnosed, surgically resectable glioblastoma and aims to assess whether localised, sustained delivery of irinotecan immediately after tumour resection can improve outcomes compared with conventional systemic chemotherapy by targeting residual tumour cells at the site of highest risk of recurrence, when they are at their lowest volume and most vulnerable to chemotherapy.

The trial, which is open label, has been designed in two parts. The first part is a dose escalation study in recurrent glioblastoma using an increasing number of irinotecan ChemoSeeds in a total of 12 patients. Pending regulatory approval from the MHRA, the first patient is expected to be dosed in Q1 2026 and this part of the trial is expected to report in Q1 2027.

The second part of the trial will use the optimum dosage from part one of the trial and will include newly diagnosed and recurrent glioblastoma patients divided across two arms, a control arm and a treatment arm. It is expected that a total of 135 patients will be treated in this part of the trial at multiple specialist neuro-oncology centres across the UK,  with 90 patients in the treatment arm and 45 in the control arm.

The second part of the trial is expected to start in H1 2027 and to report out approximately 2.5 years later.

The primary endpoint of the trial is progression free survival, and the secondary endpoint is median overall survival.

Prof. Chris McConville, Chief Scientific Officer at CRISM Therapeutics, commented: "Submitting this CTA marks a significant milestone in the clinical development of ChemoSeed. By delivering irinotecan precisely where it is needed, in the resection margin, when the tumour is at its most vulnerable and treated over a sustained period of time, this study aims to provide a new therapeutic strategy for glioblastoma, a cancer with persistently poor prognosis despite standard-of-care interventions."

Andrew Webb, CEO of CRISM Therapeutics, added: "This first-in-human trial builds on compelling preclinical data and reflects our commitment to redefining solid tumour treatment through sustained localised therapy. We are hopeful that this Phase 2 study will demonstrate the clinical impact of our ChemoSeed drug delivery platform in one of the most urgent areas of need in neuro-oncology and bring a new treatment to patients affected by this devastating disease."

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About CRISM Therapeutics Corporation

CRISM Therapeutics Corporation has developed an innovative drug delivery technology to improve the clinical performance of cancer treatments for solid tumours through the local delivery of chemotherapy drugs.

ChemoSeed, CRISM's lead product, can be implanted directly into the tumour or the resection margin following the removal of a tumour. This directs that therapeutic concentrations of chemotherapy drugs reach the deep-seated tumour tissue or cover the entire resection margin. In the case of treating high-grade glioma, ChemoSeeds can be implanted during surgery thereby bypassing the blood brain barrier, which prevents other treatments from being able to reach the tumour and be effective.

For more information please visit: https://www.crismtherapeutics.com/