Crism Thera Regulatory News (CRTX)

This announcement contains inside information for the purposes of Article 7 of the Market Abuse Regulation (EU) 596/2014 as it forms part of UK domestic law by virtue of the European Union (Withdrawal) Act 2018 ('MAR'), and is disclosed in accordance with the Company's obligations under Article 17 of MAR.

26 June 2026

CRISM THERAPEUTICS CORPORATION

('CRISM', the 'Company' or the 'Group')

FINAL RESULTS

'Regulatory milestones achieved and well-funded to advance Phase 2 Clinical Trial'

CRISM Therapeutics Corporation (AIM: CRTX), a UK clinical stage drug delivery company focused on the localised and sustained delivery of chemotherapy drugs, announces its final audited results for the year ended 31 December 2025 (the 'year'). The Annual Report is available to view on the Company's website at www.crismtherapeutics.com and copies will be mailed to shareholders shortly.

Highlights:

· MHRA Clinical Trial Authorisation ('CTA') received in September 2025, authorising the initiation of CRISM's open-label, registration-grade Phase 2 clinical trial of irinotecan-ChemoSeed in patients with surgically resectable glioblastoma

· Advance the preclinical development of docetaxel-ChemoSeed for the treatment of prostate cancer, supported by non-dilutive grant funding, further demonstrating ChemoSeed's potential as a platform technology across a broader range of solid tumour indications

· Two equity fundraises completed during the year, raising a combined total of approximately £1.93 million (before expenses): a June 2025 placing and retail offer raising £874,021 to fund GMP manufacture of the clinical trial batch, and a December 2025 placing and retail offer raising approximately £1.06 million to progress Phase 2 trial preparation

· R&D expenditure of £908,000, reflecting the Company's increased investment in clinical and pre-clinical development activities ahead of Phase 2 trial commencement

· Total assets of £1.79 million (FY2024: £1.81 million) and cash of £1.13 million as at 31 December 2025

· Loss for the year of £1.90 million (FY2024: £0.61 million), reflecting the planned step-up in operational and R&D activity.

Post period end:

· FDA Orphan Drug Designation ('ODD') awarded in March 2026 for irinotecan-ChemoSeed in the treatment of glioblastoma, providing potential US market exclusivity, tax credits for clinical trials, waiver of certain FDA fees, and enhanced FDA, strengthening commercial appeal

· Japanese patent granted in January 2026, broadening the Company's global intellectual property portfolio

· Positive preclinical efficacy and safety data reported in April 2026 for docetaxel-ChemoSeed in the Company's prostate cancer programme, validating ChemoSeed as a broader platform technology for solid tumour indications

· Confirmed completion of all manufacturing, quality, regulatory and study start-up activities, with site activation at an advanced stage and a Site Initiation Visit ('SIV') planned for late July 2026

· Significantly oversubscribed fundraise of £2,745,000 (before expenses) completed in May/June 2026 via an equity placing at 10p per share and a concurrent oversubscribed retail offer

· £896,088 Innovate UK Biomedical Catalyst grant awarded on 4 June 2026, covering 70% of the cost of Part 1 of the Phase 2 clinical trial for irinotecan-ChemoSeed in glioblastoma

· £99,902 Invest Northern Ireland grant awarded on 1 June 2026 to accelerate technical, pre-clinical and regulatory activities for the docetaxel-ChemoSeed prostate cancer programme through to March 2027

Upcoming Milestones & Outlook:

· Clinical site set-up for the Phase 2 registration-grade clinical trial of irinotecan-ChemoSeed is progressing at pace and the Company is working towards first patient dosing as soon as practicable

· CRISM continues to advance the docetaxel-ChemoSeed prostate cancer programme underpinned by positive pre-clinical data and non-dilutive grant support, with a view to preparing the asset for clinical development

· The Board remains focused on executing its strategy, with ODD and ILAP designations in place which provide important regulatory and commercial advantages, the Company looks to the future with considerable optimism

CRISM's Executive Chairman, Andrew Webb, said: "2025 was a year of significant progress for CRISM. Securing MHRA authorisation to initiate our Phase 2 clinical trial of irinotecan-ChemoSeed was a key milestone for the Company providing validation that ChemoSeed is ready to be evaluated as a potential new standard of care for glioblastoma patients, a disease where treatment options have barely changed in over 20 years.

"The momentum has continued strongly into 2026, with FDA Orphan Drug Designation, a significantly oversubscribed equity fundraise, and two non-dilutive grants totalling nearly £1 million awarded in just two weeks. We are well funded, with a Site Initiation Visit planned for late July, the final step before patient recruitment begins, and are excited about what lies ahead. On behalf of the Board, I thank our shareholders, partners and clinical collaborators for their continued support as we advance into the next stage of our development."

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 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.

Executive Chairman's Statement

I am pleased to provide the following statement as Executive Chairman of CRISM Therapeutics Corporation (the "Company" or "CRISM").

The year to 31 December 2025 saw significant progress in the development of our ChemoSeed® product for the treatment of high-grade glioma (HGG) as our lead indication, where there is significant unmet clinical need. On 1 September 2025, CRISM announced that it had received regulatory approval from the Medicines and Healthcare products Regulatory Agency ("MHRA") to initiate its open label registration-grade Phase 2 clinical trial of irinotecan-ChemoSeed in patients with surgically resectable glioblastoma. This marked a significant operational milestone and cleared the Company to commence the trial across selected clinical sites.

The Directors believe that CRISM has developed a unique drug delivery system for solid tumours in ChemoSeed owing to its ability to bypass the blood brain barrier and deliver localised, sustained treatment of chemotherapy without the harmful side effects. Given the large addressable market in brain tumours, the Company is optimistic that ChemoSeed has the potential to disrupt current drug delivery systems and improve the standard of care, which has remained unchanged for over 20 years, for many brain tumour patients across multiple markets.

CRISM achieved several significant regulatory milestones during the period. The Company secured an Innovation Passport from the UK MHRA, enabling participation in its fast-track programme for rare diseases, and subsequently received approval for its Clinical Trial Authorisation in August 2025.

In addition, CRISM was awarded Orphan Drug Designation by the FDA in March 2026 for irinotecan-ChemoSeed in the treatment of glioblastoma. The designation provides important regulatory and commercial benefits, including potential market exclusivity, tax incentives and enhanced FDA support, strengthening the Company's UK and US development strategy. The Company also continues to see significant potential for ChemoSeed across a wider range of solid tumour indications.

CRISM strengthened its financial position through a series of equity placings and retail offers, raising approximately £4.7 million (before expenses) between June 2025 and June 2026. The net proceeds are being used to fund clinical trial set-up and to commence patient dosing this year.

Included within the above, in May 2026, the Company announced it had raised a total of £2,745,000 (before expenses) via an equity placing and a retail offer by issuing a total of 27,450,000 new ordinary shares at a price of 10p. This fundraising completed following the Company's General Meeting on 15 June 2026.

To extend its cash runway, the Company implemented cost-saving measures, including renegotiating certain supplier payment terms and temporary reductions in director remuneration. CRISM also secured non-dilutive funding through grants from Innovate UK and Invest Northern Ireland of approximately £1 million, supporting the development of its pipeline and key preclinical, technical and regulatory activities.

The Board remains encouraged by the support received from regulators, partners and investors as the Company advances its clinical development programme.

Board Changes

Dr Nermeen Varawalla resigned in April 2026 in order to focus on her other professional interests. A search for a successor with the requisite skills and experience as CRISM progresses towards its Phase 2 clinical trial and future commercialisation is underway. I have assumed the role of Executive Chairman on a temporary basis.

Financial Overview

As at 31 December 2025, the Group's total assets amounted to £1.79 million decreased from £1.81 million in 2024.

The Group recognised a loss for the year of £1,903,000 (31 December 2024: loss £607,000). Administration expenses amounted to £2,009,000 (31 December 2024: £901,000), which includes research and development of £908,000, consulting fees of £132,000, broker and registrar fees of £134,000, legal and professional £186,000 and auditor's remuneration £64,000. The increase in administration expenses is a result of increased research and development activities undertaken by CRISM Therapeutics Limited, the Company's wholly owned subsidiary, as the Company prepares for its open label registration grade Phase 2 clinical trial.

Outlook

Our key objectives for 2026 are to deliver the first batch of irinotecan-ChemoSeed for the clinical trial, complete the set-up of the clinical sites that will participate in recruiting and treating patients and initiate the Phase 2 registration grade clinical trial, to assess the safety and efficacy of irinotecan-ChemoSeed.

To deliver on our ambitious goals related to progressing the clinical development of ChemoSeed in brain and prostate cancers, your ongoing support is valued. In light of the progress made to date, the commitment of the management and our team of expert external partners, we look to the future with optimism.

Andrew Webb

Executive Chairman

26 June 2026

CSO Report

I am pleased to present my Chief Scientific Officer's Report, highlighting the significant progress and achievements made during the year ended 31 December 2025 and the exciting developments that have continued into 2026.

Research and Development Update

A critical objective in this phase of CRISM's development was the submission of the Clinical Trial Authorisation (CTA) on 30 June 2025. To achieve this the Company applied for, and was awarded, an Innovation Passport from Medicines and Healthcare products Regulatory Agency (MHRA). This gained the Company entry into the Innovative Licensing and Access Pathway for fast-track support for the treatment of rare diseases. Following this award the Company sought scientific advice from the MHRA ahead of finalising the CTA application. The MHRA's written advice was received in March and the guidance was incorporated into the submission. As a result, regulatory approval was received from the MHRA on 27 August 2025.

During October 2025 CRISM submitted an application to the US Food and Drug Administration ("FDA") seeking Orphan Drug Designation ("ODD") for its lead programme, irinotecan-ChemoSeed, for the treatment of glioblastoma. ODD was awarded in March 2026, enhancing our regulatory profile and commercial attractiveness.

The FDA's ODD programme is designed to encourage the development of medicines for rare diseases affecting fewer than 200,000 patients in the United States. It provides CRISM with potential benefits including: seven years of US market exclusivity following approval; tax credits for clinical research costs; waiver of FDA application fees; and enhanced regulatory support and guidance throughout development. It forms a key part of the Company's global regulatory strategy designed to unlock accelerated development and early market access opportunities in both the US and UK

The Board believes that there is significant opportunity for ChemoSeed given the breadth of solid tumour indications that could potentially benefit from sustained local drug delivery to improve clinical outcomes.

Strategic Development - Collaborative Research Agreements

The development service contract with imphatec Limited concluded in Q2 2026. The total revenue generated from this contract amounted to £193,000 of which £169,000 was recognised in the year.

Development of a docetaxel-ChemoSeed for prostate cancer;

o  Initially supported by funding from Innovate UK - Launchpad NI to May 2026.

o  Second grant funding completed with support from Invest-NI.

o  Scientist contract now extended for a further year and project extended to June 2027.

o  Progress development of docetaxel-loaded ChemoSeed:

§ Docetaxel is a current standard of care and direct implantation will ensure maximum exposure to the drug which will be contained with the tumour.

o  Development continues to assess the pharmacokinetics, toxicity and efficacy of docetaxel-ChemoSeed in a preclinical study.

o  Seek regulatory advice from the MHRA about performing a Phase 1 'window-of-opportunity' trial in prostate cancer patients undergoing a prostatectomy.

In October 2025, the Company announced continued positive preclinical findings and a new research collaboration that mark key milestones in the development of its innovative ChemoSeed platform in prostate cancer. Prostate cancer, the most prevalent cancer in men, is the second programme in CRISM's pipeline of product opportunities using ChemoSeed.

In vitro studies conducted by CRISM have demonstrated that the sustained administration of docetaxel to prostate cancer cell lines is significantly more effective than the intermittent dosing schedules currently used in the standard of care. 

Sustained administration killed 72% of the prostate cancer cells compared with 65% with intermittent dosing. These findings strongly support the hypothesis that sustained, localised delivery of chemotherapy, enabled by ChemoSeed, could substantially enhance the efficacy of docetaxel, a generic chemotherapy drug, in the treatment of prostate cancer. 

Further strengthening its R&D capabilities, CRISM was awarded a prestigious Department for the Economy ("DfE") Collaborative Doctoral Partnership ("CDP") studentship in collaboration with Ulster University to support the ongoing development of docetaxel-ChemoSeed and explore its application in the personalised treatment of prostate cancer, including potential patient-specific dosing strategies and tumour-targeting delivery models. The DfE will cover the university tuition fees and provide a maintenance stipend to support the doctoral candidate's living expenses.

On 21 April 2026 CRISM announced further positive preclinical results for its docetaxel-ChemoSeed programme in a prostate cancer model, further validating the broader potential of the ChemoSeed platform beyond glioblastoma. The study demonstrated significant anti-tumour activity, a clear dose-response relationship and favourable tolerability compared with standard systemic docetaxel, with the strongest dose achieving a 58% reduction in tumour volume versus standard of care. No adverse tolerability effects or early terminations were observed in the ChemoSeed-treated groups, supporting the potential of localised, sustained chemotherapy delivery to improve efficacy while reducing systemic side effects. These findings represent an important step in the development of CRISM's second pipeline programme and support future partnering discussions and progression towards clinical evaluation.

Professor Chris McConville

Chief Scientific Officer

26 June 2026

CONSOLIDATED STATEMENT OF FINANCIAL POSITION

AS AT 31 DECEMBER 2025

CONSOLIDATED STATEMENT OF COMPREHENSIVE INCOME

FOR THE YEAR ENDED 31 DECEMBER 2025

CONSOLIDATED STATEMENT OF CASH FLOWS

FOR THE YEAR ENDED 31 DECEMBER 2025

CONSOLIDATED STATEMENT OF CHANGES IN EQUITY

FOR THE YEAR ENDED 31 DECEMBER 2025

NOTES TO THE FINANCIAL STATEMENTS

FOR THE YEAR ENDED 31 DECEMBER 2025

1. Basis of prePARATION

a) General Information

CRISM Therapeutics Corporation (the 'Company') is a company registered in the British Virgin Islands. The consolidated financial information as at and for the year ended 31 December 2025 comprise the results of the Company and its subsidiaries (together referred to as the "Group").

The Group has a principal activity being a biotechnology company, focused on the development of innovative drug delivery technology to improve the clinical performance of cancer treatments for solid tumours through the local delivery of chemotherapy drugs.

b) Basis of Preparation

These consolidated financial statements have been prepared under the historical cost convention. These consolidated financial statements have been prepared on the going concern basis and in accordance with International Financial Reporting Standards ('IFRS') as issued by the International Accounting Standards Board ('IASB') and interpretations issued by the International Financial Reporting Interpretations Committee ('IFRIC').

The comparative amounts are CRISM Therapeutics Limited for the year ended 31 December 2024.

The Group financial information is presented in GBP, and values are rounded to the nearest thousand Pound.

The preparation of financial statements in accordance with IFRS as issued by the IASB and interpretations issued by the IFRIC, requires management to make judgements, estimates and assumptions that affect the application of policies and reported amounts of assets and liabilities, income and expenses. The estimates and associated assumptions are based on historical experience and factors that are believed to be reasonable under the circumstances, the results of which form the basis of making judgements about carrying values of assets and liabilities that are not readily apparent from other sources. Actual results may differ from these estimates.

The estimates and underlying assumptions are reviewed on an ongoing basis. Revisions to accounting estimates are recognised in the period in which the estimate is revised if the revision only affects that period, or in the period of revision and future periods if the revision affects both current and future periods.

c) Going concern

The Group's business activities, together with the factors likely to affect its future development, performance and position, are set out in the Chairman's Statement. In addition, note 4 to the financial statement includes the Group's processes for managing its capital; its financial risk management objectives; and details of its exposure to credit and liquidity risk.

As of 31 December 2025, the Group has cash resources amounting to £1,128,000 and whilst the Group is not currently generating commercial revenue, it has been awarded grant funding in 2026 which will cover a substantial portion of the planned clinical trial expenditure. Furthermore, in June 2026 the Company completed an equity issue, raising approximately £2.75 million. This allows the Group to fund the clinical trial, prostate cancer treatment, operations, corporate overheads and continue as a going concern for the foreseeable future. 

Following modelled sensitised scenarios, management have considered various cost saving measures that could be implemented should the Group's cash burn be accelerated or to mitigate against any unforeseen circumstances that may arise.

The Directors, therefore, have made an informed judgement, at the time of approving these financial statements that there is a reasonable expectation that the Company has adequate resources to continue in operational existence. On this basis, the Directors have continued to adopt the going concern basis of accounting in preparing the annual financial statements.

d) Loss per share

Basic and diluted loss per share is calculated and set out below. In accordance with IAS 33, basic and diluted earnings per share are identical as the effect of the exercise of share options or warrants would be to decrease the loss per share.

e) Events after the reporting date

On 2 April 2026, Nermeen Varawalla resigned from her position as Non-executive Chair of the Company.

In May 2026, the Company announced it had raised a total of £2,745,000 (before expenses) via an equity placing and a retail offer by issuing a total of 27,450,000 new ordinary shares at a price of 10p. This fundraising completed following the Company's General Meeting on 15 June 2026.

On 1 June 2026, the Company announced that it has been awarded a non-dilutive research and development grant of up to £99,902 from Invest Northern Ireland to support the continued development of its docetaxel-ChemoSeed programme.

On 4 June 2026, the Company announced that it has been awarded an £896,088 non-dilutive grant from Innovate UK to support the delivery of Part 1 of the Company's open label Phase 2 registration-grade client trial for irinotecan-ChemoSeed.

-Ends-