MHRA green light puts ChemoSeed on the runway for Phase 2 in glioblastoma
CRISM Therapeutics has cleared two big regulatory hurdles for its lead programme, ChemoSeed, in surgically resectable glioblastoma. The Medicines and Healthcare products Regulatory Agency (MHRA) approved the Company’s Clinical Trial Application (CTA) on 28 August, with UK ethics approval following on 1 September. In plain English: the Phase 2 trial is now authorised to start.
The trial is described as “open label” (everyone knows what treatment they’re getting) and “registration grade” (data could support a marketing application if strong). First dosing is targeted for early Q1 2026, with clinical site selection and set-up starting now. In parallel, Good Manufacturing Practice (GMP) production of a clinical batch of irinotecan-ChemoSeed is underway with CDMO partner ProMed Pharma.
What ChemoSeed is and why it matters in brain cancer
ChemoSeed is a tiny, implantable, biodegradable polymer that delivers chemotherapy directly into tumour tissue or the resection margin after surgery. For glioblastoma, the goal is to bypass the blood-brain barrier and maintain therapeutic drug levels where they’re needed most, while reducing systemic side effects.
CRISM is using irinotecan, a pre-approved chemotherapy with prior brain use, which supports a lower risk profile than a brand-new drug. Management highlights a sizeable unmet need and an estimated £1.7 billion market opportunity in brain tumours. With an Innovation Passport and support from the Innovative Licensing and Access Pathway (ILAP), the Board believes positive Phase 2 data could potentially support early UK approval as soon as 2028. That is an ambition, not guidance, but it shows the intent.
Trial design, timing and what to watch
The Phase 2 plan has two parts. First, a dose-escalation in recurrent glioblastoma to refine safety and dosing. Second, an efficacy assessment in newly diagnosed patients, with progression-free survival as a key endpoint. This is a pragmatic route: establish the dose in the harder-to-treat recurrent setting, then look for a signal earlier in the disease course.
The Company expects to recruit from UK centres, aiming to start dosing in Q1 2026. Manufacturing has kicked off so the product is available on time. This operational cadence – approvals in place, manufacturing running, sites being initiated – is exactly what investors want to see ahead of first patient in (FPI).
Platform potential: prostate cancer moves up the agenda
CRISM is positioning ChemoSeed as a platform for solid tumours. The early prostate cancer programme is moving, backed by an Innovate UK Launchpad grant of £96,106. The initial formulation of docetaxel-ChemoSeed has been developed, targeting local delivery of a standard-of-care chemotherapy with the aim of maximising efficacy and minimising side effects.
The Company cites a large addressable market: the global prostate cancer therapeutics market was valued at USD 12.6 billion in 2024 and is forecast to grow to USD 29.9 billion by 2034 (Global Market Insights). While those are third-party numbers, they underscore the commercial rationale for a second indication.
Cash, funding and runway: where things stand
As of 30 June 2025, CRISM held £349,000 in cash. Post period, the Company raised £874,021 (before expenses) via a placing and retail offer in July, and reports net cash of £906,864 on 12 September 2025. Management has also started cost-containment measures, including a 50% reduction in Executive and Non-Executive Directors’ remuneration for six months from September 2025 and renegotiated terms with partners and suppliers.
The RNS is clear that further funding will be required to progress through clinical trials and advance the prostate programme. The accounts are prepared on a going concern basis, but there is a stated “material uncertainty” until additional financing is secured. Investors should expect continued pursuit of grants and other non-dilutive options alongside potential equity fundraising.
Key financials at a glance
| Metric | Figure |
|---|---|
| Cash at 30 June 2025 | £349,000 |
| Net cash at 12 September 2025 | £906,864 |
| Gross funds raised in July 2025 | £874,021 |
| H1 2025 loss | £930,000 |
| Administrative expenses (H1 2025) | £905,000 |
| of which R&D | £357,000 |
| Shares in issue at 30 June 2025 | 39,344,818 |
| Warrants issued (post period) | 3,333,350 at 24p, expiring 2 July 2027 |
Governance and operations: tightening the ship
CRISM has established a Scientific Advisory Board featuring neurosurgery and oncology expertise to guide the clinical strategy. The Company continues to run a lean model with one employee and outsourced functions, which keeps fixed costs lower while progressing development.
From 1 October 2025, Andrew Webb will become Executive Chairman, with the current Chair stepping back temporarily and unpaid until early 2026. This is positioned as part of the cost and focus measures as the trial gears up.
Why this matters for shareholders
Getting both MHRA and ethics approvals is the big de-risking event for 2025. It moves ChemoSeed from the “planning” bucket into “execution” for Phase 2, and that is often where partnerships, grants and investor interest pick up. Manufacturing start further validates the operational readiness.
The flip side: cash remains tight and there is an explicit need for further funding to run the trial. The near-term newsflow should help, but financing timing and terms are key sensitivities. As ever in small-cap biotech, the path is binary around clinical outcomes, and timelines can slip. CRISM is open-label, which can allow earlier reads, but the RNS does not guide to interim data – not disclosed.
Upcoming catalysts to watch
- Site selection and initiation for the Phase 2 glioblastoma trial – expected in the coming months.
- First patient dosed in Q1 2026.
- Updates on GMP batch completion and readiness for shipment to sites.
- Further non-dilutive funding wins for the prostate programme and beyond.
- Any guidance on recruitment pace or initial safety signals once dosing begins – not disclosed today.
My take: progress is real, funding is the swing factor
This is a constructive half-year update. The approvals came through, manufacturing is underway, and the platform angle is gaining traction with a defined prostate plan and a £96,106 Innovate UK grant. The scientific logic of localised chemotherapy in glioblastoma is sound, and using a known drug like irinotecan sensibly lowers development risk.
However, the finances are finely balanced. Post-raise cash of £906,864 as of 12 September gives some breathing room, but not enough to see a full Phase 2 through. Expect further funding steps – ideally grants or partnerships to limit dilution, but equity is likely part of the mix.
Net-net: a positive operational stride that puts CRISM on the threshold of a potentially registrational Phase 2. Execution on funding and trial start will determine how the story trades into 2026.
Engage with management
Management will present via Investor Meet Company at 12.00pm BST on 16 September 2025. You can register here: Investor Meet Company – CRISM Therapeutics. For company background, see crismtherapeutics.com.
This article is an interpretation of the Company’s RNS. It is not investment advice.
