CRISM Therapeutics Reports Final Results and Advances Phase 2 Trial for Glioblastoma

CRISM Therapeutics final results show a glioblastoma Phase 2 story that is finally moving

CRISM Therapeutics has delivered a set of final results that matter less for historic revenue and more for one big question: is the lead glioblastoma programme actually getting closer to patients? On that front, the answer looks like yes.

The standout point is that the company received MHRA Clinical Trial Authorisation in 2025 for its open-label, registration-grade Phase 2 trial of irinotecan-ChemoSeed in surgically resectable glioblastoma. In plain English, open-label means doctors and patients know what treatment is being given, and registration-grade means the study is being designed to support future regulatory discussions if the data are good enough.

This is important because small biotech companies can spend years talking about promise. CRISM has now pushed through a real regulatory gate and says manufacturing, quality, regulatory and study start-up work are complete, with a Site Initiation Visit planned for late July 2026. That is the sort of operational update investors want to see.

Key CRISM Therapeutics numbers from the 2025 final results

Metric	2025	2024
Total assets	£1.797 million	£1.816 million
Cash and cash equivalents	£1.128 million	£1.282 million
Loss for the year	£1.903 million	£607,000
Administrative and other expenses	£2.009 million	£901,000
R&D expenditure	£908,000	Not disclosed separately in the headline summary
Equity raised in 2025	Approximately £1.93 million before expenses	Not comparable
Post period fundraise	£2.745 million before expenses	Not applicable

MHRA approval, FDA Orphan Drug Designation and ILAP support give CRISM more credibility

For an early-stage biotech, regulatory progress is a currency of its own. CRISM already had an Innovation Passport from the MHRA and access to the Innovative Licensing and Access Pathway, or ILAP, which is a fast-track support route for innovative medicines. It then secured the Clinical Trial Authorisation in August 2025, announced in September 2025.

Since the year end, the company has also been awarded FDA Orphan Drug Designation for irinotecan-ChemoSeed in glioblastoma. That matters because orphan status can bring seven years of US market exclusivity after approval, tax credits for clinical research, waiver of certain FDA fees and more regulatory support.

None of that guarantees success in the clinic, and that is the bit investors should keep in bold in their heads. But it does improve the commercial shape of the opportunity if the data come through.

CRISM cash position looks better after the year end than it did on 31 December 2025

At the year end, CRISM had £1.128 million of cash. On its own, that is not a huge number for a clinical-stage biotech heading into a Phase 2 trial, so if you stopped reading there, you would miss the bigger picture.

After the period end, the company completed a significantly oversubscribed fundraise of £2.745 million before expenses at 10p per share. It also won two non-dilutive grants – meaning money that does not require issuing more shares – worth £896,088 from Innovate UK and £99,902 from Invest Northern Ireland.

The most important of those is the Innovate UK Biomedical Catalyst grant, because CRISM says it covers 70% of the cost of Part 1 of the Phase 2 glioblastoma trial. That is a strong validation point and a useful reduction in cash pressure.

Management says the combination of cash, the June 2026 equity issue and grant support allows the group to fund the clinical trial, prostate cancer work, operations and corporate overheads as a going concern for the foreseeable future. For investors, that meaningfully reduces near-term funding anxiety, though it does not remove it forever.

Why the bigger CRISM loss is not a surprise – but dilution is the price of progress

The loss for 2025 widened sharply to £1.903 million from £607,000. That looks ugly on the surface, but for a pre-revenue biotech preparing a Phase 2 trial, it is not unexpected.

Administrative and other expenses rose to £2.009 million from £901,000, driven largely by increased development work. Within that, R&D expenditure was £908,000, legal and professional fees were £186,000, consulting fees were £132,000, broker and registrar fees were £134,000, and auditor remuneration was £64,000.

The company still reported no commercial revenue. There was £231,000 of other income and the imphatec development service contract generated total revenue of £193,000, of which £169,000 was recognised in the year, but this is not a revenue-generating operating business yet. It is still a funding-led development story.

The catch, of course, is dilution. CRISM raised money several times, with approximately £4.7 million before expenses raised between June 2025 and June 2026. That helps the science move forward, but existing shareholders own a smaller slice each time new shares are issued.

Docetaxel-ChemoSeed gives CRISM a second programme beyond glioblastoma

This RNS is not just about brain cancer. CRISM is also pushing docetaxel-ChemoSeed in prostate cancer, and that matters because platform stories usually get stronger when there is more than one asset in play.

The company reported positive preclinical data in April 2026, including a 58% reduction in tumour volume versus standard of care at the strongest dose tested. It also said there were no adverse tolerability effects or early terminations in the ChemoSeed-treated groups.

That is encouraging, but investors should be disciplined here. Preclinical data are interesting, not decisive. The real value is that this supports the idea that ChemoSeed could be a broader local drug delivery platform for solid tumours, rather than a one-shot glioblastoma bet.

What this CRISM RNS means for retail investors

• The positive case: real regulatory progress, a trial that looks close to starting, fresh funding, grant support and a second programme showing useful signs of life.
• The negative case: no commercial revenue, a much larger annual loss, repeated equity raises and the core clinical trial still not yet dosing patients.
• The practical takeaway: CRISM looks better funded and better prepared than it did a few months ago, but the investment case still hinges on clinical execution.

My view is that this is a constructive update. It is not a victory lap, because biotech investors only really get paid when clinical data deliver, but it is a meaningful de-risking step operationally and financially.

If CRISM can move from site initiation into patient recruitment and then produce credible Phase 2 data, the story could change gear. Until then, this remains a speculative AIM biotech with genuine momentum, but also with the usual high-risk, high-dilution profile that comes with the territory.