15 September 2025

CRISM Therapeutics Corporation

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

Half Year Report for the six month period ended 30 June 2025

CRISM Therapeutics Corporation (AIM: CRTX), a UK clinical-stage drug delivery company focused on the localised and sustained delivery of chemotherapy drugs, today announces its unaudited half-year results for the six months ended 30 June 2025 (the "Period").

The Company has made significant progress during the Period in advancing its proprietary ChemoSeed™ drug delivery technology towards a Phase 2 clinical trial.  ChemoSeed is an implantable, biodegradable technology designed for the localised and sustained delivery of chemotherapy directly into cancer tissue thereby improving clinical performance. ChemoSeed has an attractive risk profile owing to its use of pre-approved chemotherapy drugs such as irinotecan.

CRISM's initial therapeutic focus is in brain tumour, owing to the very significant unmet need and attractive market size of an estimated £1.7 billion. The Board believes ChemoSeed is a platform technology for other solid tumours, such as prostate, pancreatic and bladder, and the Company has already begun early work targeting prostate cancer, a major indication and the most prevalent cancer in men.

Highlights in the year to date

·   Submission of a Clinical Trial Application ("CTA") for the Company's open label, registration grade Phase 2 clinical trial of irinotecan-ChemoSeed in resectable glioblastoma to the Medicines & Healthcare product Regulatory Agency ("MHRA") on 30 June 2025

·   CTA approval received subsequently as announced on 1 September 2025

·   Favourable ethics committee approval also announced on 1 September 2025 from a UK Research Ethics Committee to approve the start of the Phase 2 trial, which is expected to commence in early Q1 2026

·   Initiated GMP ("Good Manufacturing Practice") manufacture of a clinical batch of irinotecan-ChemoSeed for the Company's Phase 2 clinical trial

·   Established Scientific Advisory Board to provide the Company with expert guidance on its clinical trial

·   Company awarded an Innovate UK Launchpad grant of £96,106 to support the formulation and preclinical development of ChemoSeed in prostate cancer with work commencing in May 2025

·   Company raised £874,021 via a placing and retail offer in July 2025 (post period end)

·   Net cash at 12 September 2025 of £906,864

Commenting on the Interim Results, CRISM CEO Andrew Webb said: "We are very pleased with the progress made in the first six months of the financial year, and in progress since the half-year end. Our Clinical Trial Application has been approved, ethical approval granted and GMP manufacture of a clinical batch of irinotecan-ChemoSeed is underway. We are now focused on commencing set up of clinical trial centres in the UK so that patient recruitment in our open label, registration grade Phase 2 study in glioblastoma can begin. We continue to expect that the first patients will be dosed in Q1 2026.

"We have also made good progress in our early stage programme in prostate cancer, the most prevalent type of cancer in men.  The initial formulation of docetaxel-ChemoSeed has been developed and the Company is seeking non-dilutive grant funding to accelerate development of the programme.

"Key milestones in the remainder of the year include the selection and initiation of clinical trial sites ahead of patient recruitment early next year." 

Presentation via Investor Meet Company

Andrew Webb, CEO of CRISM Therapeutics, will host a live presentation via Investor Meet Company on Tuesday 16 September 2025 at 12.00pm BST. The presentation will include Garth Cruickshank, Emeritus Professor of Neurosurgery at University of Birmingham and Queen Elizabeth Hospital Birmingham, and a member of CRISM's Scientific Advisory Board.

The Investor Meet Company presentation is open to all existing and potential shareholders. Questions can be submitted pre-event via the Investor Meet Company dashboard up until 9.00am BST on 15 September 2025 or at any time during the live presentation.

Investors can sign up, free of charge, to Investor Meet Company and add to meet CRISM Therapeutics via: https://www.investormeetcompany.com/crism-therapeutics-corporation/register-investor

Investors who already follow the Company on the Investor Meet Company platform will automatically be invited.

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.

-Ends

Enquiries:

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 ensures 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.

CRISM is expected to dose the first patients in its registration-grade Phase 2 clinical trial of irinotecan-ChemoSeed in patients with surgically resectable glioblastoma in Q1 2026.

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

The Company's LEI is 213800XFW6MKVCHHPW88.

CEO REPORT

Introduction

I present my CEO Statement for CRISM Therapeutics for the six-month period ended 30 June 2025. 

Background

CRISM is a UK-based pharmaceutical company which has developed an innovative drug delivery technology, ChemoSeed, to improve the clinical performance of cancer treatments for solid tumours through the local delivery of chemotherapy.  ChemoSeed is a polymer based implant, the size of a grain of rice, administering irinotecan, a generic drug approved to treat brain cancer and can be implanted directly into a tumour or the resection margin following the removal of a tumour.  ChemoSeed will initially be used to treat glioblastoma, an aggressive form of brain tumour with no satisfactory treatment. ChemoSeeds will be implanted during surgery to bypass the blood brain barrier, which prevents other treatments from being able to reach the tumour and be effective. 

CRISM operates in a significant market where brain tumour is the biggest cancer killer of children and adults under the age of 40.  In the UK, approximately 12,000 new cases are diagnosed annually, with an estimated 60,000 people living with the condition. Despite this, just one per cent of cancer research funding has been allocated to brain tumour since records began in 2002. 

ChemoSeed addresses a significant, unmet medical need in the treatment of brain tumour. There are no current cures and present treatments merely seek to extend life, often by just a few months, with serious adverse side effects. Each ChemoSeed consists of the pre-approved chemotherapy drug, irinotecan, and the biodegradable polymer PLGA, both of which have been previously administered to the brain with no toxicity issues. The treatment's low side-effect profile, combined with the unmet medical needs of the target market for ChemoSeed, means CRISM could potentially receive early marketing authorisation in the UK on the back of positive Phase 2 clinical trial data. This could potentially be received in 2028 under the Company's Innovation Passport and support from the Innovative Licensing and Access Pathway (ILAP). 

Operational Update

Significant progress has been made in the current year with priority on the development path for brain tumour with the submission of the CTA for the Company's registration grade Phase 2 clinical trial of irinotecan-ChemoSeed in resectable glioblastoma to the MHRA on 30 June 2025 which was subsequently approved by the MHRA on 28 August 2025.  The submission incorporated prior Phase 1 data where irinotecan was delivered locally in brain tumour patients and preclinical data which demonstrated the Company's ChemoSeed implantable drug delivery technology to sustain efficacious drug concentration in the residual tumour.  CRISM has a two part trial planned; there will be a dose escalation in patients with recurrent glioblastoma followed by efficacy assessment based on progression free survival in newly diagnosed patients with glioblastoma. The Company expects to treat the first patients in the Phase 2 trial in Q1 2026.  

The GMP manufacturing of a clinical batch has been initiated in order to be clinical trial ready.   The implants will be produced for the Company's upcoming open-label Phase 2 safety and efficacy trial evaluating ChemoSeed.  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.

The Company is demonstrating ChemoSeed's potential as a platform for other cancers with the development of a prostate cancer treatment.  To this end the Company was awarded an Innovate UK grant of £96,106 to support the formulation and preclinical development of ChemoSeed in prostate cancer with work commencing in May 2025.  Prostate cancer is now confirmed as the most prevalent cancer in men and the global prostate cancer therapeutics market was valued at USD 12.6 billion in 2024. The market is expected to reach from USD 13.5 billion in 2025 to USD 29.9 billion in 2034, growing at a CAGR of 9.2% during the forecast period (Global Market Insights Inc. Report: GMI10189: March 2025).  The Company has initiated development of a ChemoSeed loaded with docetaxel which is current Standard of Care for patients diagnosed with advanced prostate cancer, the opportunity for local delivery rather than systemic treatment aims to maximise efficacy whilst minimising the side effects of the chemotherapy.

Our contract formulation service work continues with the contract for imphatec, announced last year, progressing to plan.

Work continues to secure grant and other non-dilutive funding.  An example of this is the Innovate UK Launchpad: life and health sciences grant award to start our prostate programme.

Intellectual Property (IP) Development

CRISM recognises the importance of obtaining and protecting the Company's intellectual property and the necessary intellectual property for ChemoSeed has been assigned to CRISM. As of 30 June 2025, the Company has an EU patent granted and IP protection is progressing in USA, China and Japan.

People and Organisation

A Scientific Advisory Board (SAB) has been established to provide the Company with expert guidance on its clinical trial authorisation.  The SAB comprises Garth Cruickshank, Emeritus Professor of Neurosurgery at the University of Birmingham and Dr. Vinton Cheng, Associate Clinical Professor and Honorary Consultant in Medical Oncology at the University of Birmingham.

The Directors of CRISM are cognisant of the importance of minimising overheads given its stage of development and as such the Group's management team continues to outsource a number of functions including contract development, clinical research and certain administrative functions. Consequently, the Company only has one employee in addition to its four Directors. 

Financial Review

These interim financial statements present results for the Group for the period from 1 January to 30 June 2025 and the comparative results are that of the Group for the period from the Company's readmission to AIM on 31 May 2024, combined with the results of CRISM Therapeutics Limited for the period 1 January 2024 to 31 May 2024.

The Group recognised a loss for the Period of £930,000 (H1 2024: £13,000). In the first half of 2025, administration expenses amounted to £905,000 (H1 2024: £300,000), which includes research and development of £357,000, Directors fees of £139,000, professional fees of £160,000, insurance of £79,000, and consulting fees of £47,000.  In the first half of 2024, administration expenses amounted to £300,000, which includes research and development of £75,000, consulting fees of £105,000, and professional fees of £77,000.

As of 30 June 2025, the Company held £349,000 in cash (December 31, 2024: £1,282,000). In June and July 2025, the Company completed a placing (the "Placing") and retail offer to raise £874,021 (before expenses). These cash balances are anticipated to provide the Company with sufficient resources to fund the ongoing costs of its clinical trial submission and working capital requirements.

Post Period-End Events

On 3 July 2025 the Company allotted 6,666,668 new Ordinary Shares in respect of the Placing. The Company issued participants of the Placing with one warrant for every two placing shares, and as a result, 3,333,330 warrants were issued to the placees. Both the issuance of new ordinary shares and warrants were approved by the Board on 30 June 2025.

On 2 July 2025 the Company raised gross proceeds of £54,021 (before expenses) by way of a subscription of 450,176 new ordinary shares in the Company at a price of 12 pence per share. The Company also raised  £20,000 by way of an additional placing, issuing 166,666 placing shares..

On 26 August 2025 the Company adopted an Enterprise Management Incentives Option Plan to recruit, retain and incentivise key talent, the terms of which were approved by shareholders at the Company's annual general meeting.

Outlook

As we look ahead the Company is actively preparing for the commencement of its open label, registration grade, Phase 2 clinical trial in glioblastoma.  Following the CTA approval from the MHRA announced earlier this month, plans are now being finalised to commence set up of the clinical trial centres with the expectation of patient recruitment early in 2026 with the goal of dosing the first patients in Q1 2026. The first part of the trial is focusing on patients who have been diagnosed as recurrent, meaning those whose brain tumour has returned, and the second part of the trial will also include newly diagnosed patients.

The costs of running a clinical trial of this scope are significant and the Directors have taken steps to maximise the Company's cash runway.  These steps include the negotiation of more favourable terms and payment schedules from key partners and suppliers. We are grateful for the support and flexibility that these partners and suppliers have shown.

In addition, the Executive and Non-Executive Directors have agreed to a 50% reduction in their remuneration for the six months commencing September 2025. Further, with effect from 1 October 2025, Andrew Webb will assume the role of Executive Chairman and Dr Nermeen Varawalla, currently Chair, will step back from the Board and be unpaid. Dr Varawalla will return to the role of Chair during early 2026.

The Company stated at the time of its fundraising in July 2025 that the proceeds of the placing and retail offer would support the GMP manufacture of a clinical trial batch of irinotecan-ChemoSeed, the CTA approval process through to first patients dosed in the Phase 2 clinical trial. The Group continues to seek further grant funding, and other Government support.

The Directors are also seeking non-dilutive financial support for the development programme in prostate cancer, the most prevalent type of cancer in men.  This programme is progressing well, with the successful initial formulation of docetaxel-ChemoSeed.   

The Board views the future with confidence as we continue to advance ChemoSeed in glioblastoma and prostate cancer indications, leveraging the Company's proprietary drug delivery technology.

Andrew Webb

Chief Executive Officer

12 September 2025

CRISM THERAPEUTICS CORPORATION

consolidated STATEMENT OF FINANCIAL POSITION

AS AT 30 June 2025

Approved on behalf of the Board on 12 September 2025

Chief Executive Officer