GMP Manufacture of ChemoSeed

12 August 2025

CRISM Therapeutics Corporation

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

GMP Manufacture of ChemoSeed for Phase 2 Clinical Trial in Glioblastoma

CRISM Therapeutics (AIM: CRTX), the innovative UK drug delivery company focused on the localised delivery of chemotherapy drugs, announces the initiation of production of a clinical batch of ChemoSeed, its proprietary sustained-release implant containing irinotecan, under Good Manufacturing Practice (GMP).

This clinical batch will be produced for the Company's upcoming open-label Phase 2 safety and efficacy trial evaluating ChemoSeed administered directly into the resection margin in patients with surgically resectable glioblastoma. US-based ProMed Pharma LLC, a Contract Development and Manufacturing Organisation ("CDMO"), will produce the clinical batch.

The start of production marks a critical step toward first patient dosing, expected in Q1 2026, and underscores CRISM's commitment to addressing the significant unmet need in glioblastoma, a highly aggressive brain cancer with poor prognosis and limited effective treatment options. 

The Phase 2 study is designed to evaluate both safety and efficacy following direct administration of ChemoSeed into the tumour resection margin, with the goal of delivering a local high-dose of chemotherapy over a sustained period of time, while minimising systemic toxicity. This innovative approach builds on positive preclinical and early clinical data and has the potential to redefine the standard of care in post-surgical glioblastoma management.

Andrew Webb, Chief Executive Officer of CRISM Therapeutics, commented: "Initiating GMP manufacturing of ChemoSeed for our upcoming Phase 2 trial is an important step towards bringing a potentially transformative therapy to glioblastoma patients. This achievement reinforces CRISM's leading position in the localised and sustained delivery of chemotherapeutics and advances our mission to improve outcomes in some of the most challenging cancers."

Jim Arps, Director of Business Development at ProMed Pharma LLC, commented: "We are proud to support CRISM Therapeutics in the GMP manufacture of ChemoSeed for their innovative glioblastoma program. Our team is committed to ensuring timely and compliant production of this novel treatment, which represents a promising new approach to post-surgical cancer treatment."

The Company will provide further updates on its Clinical Trial Application, clinical site activation and patient enrolment timelines in due course.

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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 glioblastoma, 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/

The Company's LEI is 213800XFW6MKVCHHPW88.

About ProMed Pharma

ProMed Pharma specializes in the molding and extrusion of drug-loaded silicones, thermoplastics, and bioresorbable materials, leveraging this expertise to manufacture long-term implants and combination devices under cGMP. Working with both established and early-stage companies, we utilize robust manufacturing processes for controlled release of APIs utilizing a variety of materials. From clinical trial materials to commercial products, ProMed supports pharmaceutical and medical device companies developing controlled release formulations including subcutaneous, orthopedic, cardiovascular, and ophthalmic implants, intravaginal rings, and steroid-eluting combination components. The company has facilities in Plymouth and Maple Grove, Minnesota.

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