Scancell Reports Positive Phase 2 Data and Financial Results for FY 2025

Scancell’s FY25: standout melanoma data, early Modi-1 signals, and a clearer path to registration

Scancell’s full-year update mixes punchy Phase 2 data with a steadier financial picture and clearer plans for late-stage development. The headline is iSCIB1+, the next-generation DNA ImmunoBody for advanced melanoma, which continues to look like a credible add-on to checkpoint inhibitors. There is also early promise from Modi-1 in head and neck cancer, plus a bigger push on the antibody side with Genmab. Cash now reaches into the second half of 2026, albeit with a going concern flag to keep on your radar.

iSCIB1+ melanoma data: compelling PFS and a larger patient reach

The SCOPE Phase 2 programme continues to deliver. Scancell’s focus is the defined HLA target population, which is a genetic “address label” that determines who responds to the vaccine. In that group, iSCIB1+ added to doublet checkpoint therapy delivered a strong progression-free survival (PFS) signal and robust response rates.

SCOPE results investors should know

• 11-month PFS in the target HLA population: 78% with iSCIB1+ plus ipilimumab and nivolumab, versus historic 12-month PFS of 46% for the doublet alone.
• Across Cohorts 1 and 3 combined, 22-month PFS in the target HLA population: 69%.
• Cohort 3 target HLA population: disease control rate (DCR) 81% and overall response rate (ORR) 65%.
• Cohort 1 (SCIB1 plus doublet) ORR 63%, DCR 83%, and PFS at 23 months of 56%.
• Cohort 2 (SCIB1 plus pembrolizumab) PFS at 12 months of 57% versus 35% for pembrolizumab alone. DCR 70%.
• Safety across 100+ patients remains favourable, with fewer high-grade events attributed to SCIB1/iSCIB1+ than to checkpoint inhibitors.

PFS is the company’s planned registration endpoint, which matters because it can shorten time to a pivotal readout. Crucially, iSCIB1+ broadens potential coverage to around 80% of late-stage melanoma patients (vs 30-40% for first-generation SCIB1) and comes with a longer patent life to 2039. That combination of clinical signal, scale of addressable population and IP protection is the meat of the investment case here.

Manufacturing, delivery, and regulatory path

• Commercial-scale GMP process in place for iSCIB1+, with long-term stability at -20°C. That eases logistics and cost by avoiding ultra-cold storage.
• Strategic supply partnership with PharmaJet’s Stratis needle-free device. No lipid nanoparticles needed.
• Regulatory meetings with FDA, MHRA and EMA slated for 2025, with randomised registration-path studies anticipated to start in 2026.
• Cohort 4 will test an accelerated dosing schedule and intradermal delivery. Initial data expected in Q4 2025, intended to refine, not delay, the plan.

Modi-1 Moditope: early clinical validation in head and neck cancer

Modi-1 is a peptide vaccine from the Moditope platform. In a small head and neck cancer cohort, combining Modi-1 with pembrolizumab delivered an ORR of 43% (3/7 partial responses), which compares favourably to historic single-agent checkpoints (pembrolizumab 19%, nivolumab 13%). It is early and low-n, but it validates the combination concept and justifies pushing on.

Recruitment in renal cell carcinoma with doublet checkpoint therapy is going well, with further data expected in Q4 2025. The team has also optimised the formulation and moved to a robust, scalable GMP process. Patent protection has been strengthened, including approval by the USPTO.

Antibodies: Genmab validation and GlyMab subsidiary

Two deals with Genmab now sit behind Scancell’s GlyMab platform. The second licence for SC2811 brought $6 million in upfront payments and up to $630 million in potential milestones plus low single-digit royalties. Development of the first partnered antibody, SC129, remains on track with further milestone payments anticipated in the near-term. Combined, potential milestones across both Genmab deals reach up to $1.25 billion.

Scancell has also incorporated GlyMab Therapeutics Limited as a wholly owned subsidiary to hold antibody assets and platforms. Lead in-house assets SC134 and SC27 are being advanced towards the clinic, with SC134 showing promise in small cell lung cancer as a T-cell engager and antibody-drug conjugate.

FY25 financials: revenue from Genmab, trimmed operating loss, runway into H2 2026

Revenue	£4.711 million (2024: nil), from the second Genmab licence
Operating loss	£15.0 million (2024: £18.3 million)
Loss for the year	£12.3 million (2024: £5.9 million)
R&D expenses	£14.686 million (2024: £12.871 million)
Administrative expenses	£4.788 million (2024: £5.396 million)
Cash and cash equivalents	£16.9 million at 30 April 2025 (2024: £14.8 million)
Capital raise	Gross £11.3 million in Dec 2024; net proceeds £10.6 million
R&D tax credit	£3.031 million (2024: £3.258 million)
Convertible loan notes	£19.2 million outstanding at 30 April 2025; £18.2 million post-period after £1.0 million early redemption
Shares in issue	1,036,781,403 at 30 April 2025

Cash runway is guided through to the second half of 2026, with the notes to the accounts referencing into the third calendar quarter of 2026. The auditor flagged a material uncertainty over going concern, which is common for clinical-stage biotechs but still important. Scancell points to potential partnering, out-licensing and the antibody business as avenues for non-dilutive or less dilutive funding as programmes scale.

Why this update matters

iSCIB1+ is shaping up as a serious contender to augment first-line therapy in advanced melanoma. The 78% 11-month PFS in the target HLA population and a 69% 22-month PFS across cohorts compared with historic doublet therapy is clinically meaningful. Add better tolerability, a much larger addressable population and de-risked manufacturing, and the company has a clean story heading into regulatory meetings.

Modi-1’s 43% ORR in head and neck is early but encouraging. On antibodies, the second Genmab licence and the creation of GlyMab Therapeutics Limited sharpen the strategic options and could provide milestone and royalty upside over time.

Balanced take: positives and pressure points

• Positives: strong PFS and response data in the target HLA population for iSCIB1+; favourable safety; broader reach to 80% of patients; commercial-scale manufacturing; visible regulatory path to randomised studies in 2026; real cash receipts from Genmab and a strengthened leadership team.
• Watch-outs: comparisons are versus historic controls, not head-to-head; the non-target HLA group showed less benefit; small numbers in some cohorts; a material going concern flag remains; convertible loan notes are still sizeable; large randomised trials will require further funding or a partner.

Key clinical and corporate milestones to watch

• Q4 2025: further iSCIB1+ Cohort 3 data and initial Cohort 4 readout on accelerated dosing and intradermal delivery.
• Q4 2025: Modi-1 updates in head and neck cancer and renal cell carcinoma in combination with checkpoint inhibitors.
• 2025: planned regulatory meetings with FDA, MHRA and EMA to set up randomised registration-path studies.
• 2026: initiation of randomised studies for iSCIB1+ on the path to registration.
• Antibodies: potential near-term milestones from Genmab on SC129, plus partnering options for SC134 and the broader GlyMab pipeline.

My view as a retail-focused analyst

The melanoma data are the strongest yet from Scancell and, in my view, justify the move to randomised studies. If the PFS advantage holds up in a larger, controlled setting within the target HLA population, iSCIB1+ could become a best-in-class add-on to checkpoint inhibitors. The expanded addressable population and 2039 patent life amplify the commercial potential.

Finances are acceptable for now, helped by the Genmab revenue and tax credit, but the company will need either a partner or fresh capital for registrational work. The antibody unit provides strategic optionality and could chip in with milestones. Overall, this is a materially de-risking year for Scancell, but execution through 2026 will be the real test.