IMCR — what changed in the latest 10-Q

Text added vs the prior filing · source: 10-Q · 2026-05-06

• We presented the five-year overall survival (OS) from our pivotal Phase 3 trial with KIMMTRAK in unresectable or mUM, in an oral session at the American Association for Cancer Research (AACR) 2026 meeting. This is the longest, prospective Phase 3 randomized trial in patients with unresectable or mUM…

• In the Phase 3 trial, KIMMTRAK doubled the likelihood of being alive at five years, with an OS for KIMMTRAK of 16% versus 8% in the control arm (hazard ratio of 0.67 [95% CI: 0.54-0.85]).

• In the trial, 378 patients were randomized to tebentafusp (252) or investigator’s choice (126; 82% pembrolizumab). The median OS was 21.6 months on KIMMTRAK, versus 16.9 months on investigator’s choice (IC). The Kaplan–Meier survival curves separated early and remained separated over time, confirmin…

• The OS benefit with KIMMTRAK was observed regardless of known poor prognostic factors at baseline (high tumor burden [≥10cm]; elevated lactate dehydrogenase) or tumor location (hepatic only; hepatic and extra-hepatic). OS benefit was also observed in patients with a best response of progressive dise…

• More patients continued treatment beyond progression in the KIMMTRAK arm than in the control arm (57% vs 25%) – with the trial allowing this option in both arms. Patients on KIMMTRAK achieved nearly a 7-fold higher rate of tumor reduction with treatment beyond initial progression compared to IC pati…

Text removed vs the prior filing · source: 10-Q · 2025-11-06

• The Independent Data Monitoring Committee ("IDMC") has recommended the dose of 160 mcg as the go-forward dose in PRISM-MEL-301, our registrational Phase 3 trial in first-line, advanced cutaneous melanoma. The IDMC made the decision following a pre-planned review of safety for all three arms and of e…

• We will present a poster, entitled "IMC-I109V, a soluble T cell receptor (TCR) bispecific targeting HBsAg (ENVxCD3), is tolerable and active against hepatitis B in a first-in-human (FIH) single ascending dose (SAD) study" (Poster 1185), at the 2025 American Association for the Study of Liver Disease…

• Under the RDEC program, tax credits for qualifying R&D expenses incurred prior to April 1, 2023 are granted at a headline rate of 13% and can generate cash rebates of up to 10.5% of qualifying R&D expenses. The headline rate under the RDEC program increased from 13% to 20% on April 1, 2023 and can g…

• Unsurrendered tax losses are carried forward to be offset against future taxable profits. After accounting for tax credits receivable, there were accumulated tax losses available for carry forward in the United Kingdom of $275.7 million as of September 30, 2025. A full valuation allowance is recogni…

• For the three months ended September 30, 2025, our external R&D expenses increased by $16.1 million due to an increase in all other external clinical and preclinical costs of $9.2 million related to continued progress in the pipeline, primarily for our autoimmune programs, including clinical materia…