Awarding of Orphan Drug Designation by the FDA

The information contained within this announcement is deemed to constitute inside information as stipulated under the Market Abuse Regulation (EU) No. 596/2014, as incorporated into UK law by the European Union (Withdrawal) Act 2018. Upon the publication of this announcement, this inside information is now considered to be in the public domain.

17 March 2026

CRISM Therapeutics Corporation

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

Awarding of Orphan Drug Designation by the FDA

CRISM Therapeutics Corporation (AIM: CRTX), a UK clinical-stage drug delivery company focused on the localised and sustained delivery of chemotherapy drugs, today is pleased to announce that the U.S. Food and Drug Administration ("FDA") has granted Orphan Drug Designation ("ODD") to irinotecan for the treatment of malignant glioma, which is broader than the original designation request for glioblastoma (a Grade IV glioma) and includes all high grade (Grade III and IV) gliomas.

The award of ODD represents an important regulatory and commercial milestone for CRISM and strengthens the development and value proposition of the irinotecan-ChemoSeed programme.

ODD is granted by the FDA to encourage the development of treatments for rare diseases affecting fewer than 200,000 people in the U.S. The designation provides certain incentives, including a potential seven years of U.S. market exclusivity upon product approval, tax credits for qualified clinical trials, and an exemption from FDA application fees.

This U.S. regulatory milestone follows the previously granted Innovation Passport for the ChemoSeed™ platform by the UK's Medicines and Healthcare products Regulatory Agency (MHRA) under the Innovative Licensing and Access Pathway (ILAP).

The Company believes that this designation significantly enhances the strategic and commercial profile of the irinotecan-ChemoSeed programme.

CRISM believes that the combination of ILAP participation in the UK and ODD in the United States places irinotecan-ChemoSeed in a strong position for coordinated regulatory interaction across major jurisdictions as the registration-grade Phase 2 clinical trial of Irinotecan ChemoSeed in surgically resectable glioblastoma progresses.

Innovative oncology therapies may also be considered for international collaborative review programmes such as Project Orbis, led by the FDA, which enables participating regulators to review promising cancer treatments concurrently. While participation in such programmes is determined by regulators, CRISM believes that the regulatory designations and engagement achieved to date create a supportive framework for potential streamlined global regulatory development for irinotecan-ChemoSeed.

Together, these coordinated efforts are designed to position ChemoSeed for accelerated development, regulatory review, and commercial readiness across key global markets.

Professor Chris McConville, Chief Scientific Officer of CRISM Therapeutics, commented:"Receiving Orphan Drug Designation from the FDA is a strong validation of the potential of irinotecan-ChemoSeed. From a strategic perspective, this designation enhances the regulatory profile and potential commercial attractiveness of the programme and supports our strategy of advancing differentiated oncology assets that address significant unmet medical needs. When combined with our Innovation Passport and participation in the UK's ILAP programme, we believe irinotecan-ChemoSeed is well positioned for constructive regulatory engagement as we progress with our registration-grade Phase 2 clinical trial of Irinotecan ChemoSeed in surgically resectable glioblastoma.''

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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.