Company: IMCR
Filing Date: 2025-05-07
Form Type: 10-Q
Source: 0001671927-25-000009
Chunk: 72

Company: Immunocore Holdings plc
Filing Date: 2025-05-07
Form: 10-Q
Item: Part I, Item 8
Chunk 72
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 arrangements, collaborations and marketing and distribution and licensing arrangements. We may be unable to raise additional funds or enter into such other arrangements on favorable terms, or at all, particularly in light of recently worsening macroeconomic conditions, such as supply chain disruptions, fluctuations in interest rates and volatility in the capital markets. If we fail to raise capital or enter into such arrangements as, and when, needed, we may have to significantly delay, scale back or discontinue the development and commercialization of one or more of our programs.

Because of the numerous risks and uncertainties associated with pharmaceutical development, we are unable to predict the timing or amount of future revenues, increased expenses or when or if we will be able to achieve or maintain profitability. If we fail to become profitable or are unable to sustain profitability on a continuing basis, then we may be unable to continue our operations at planned levels and may be forced to reduce our operations.

Recent Developments

In March 2025 at the Conference on Retroviruses and Opportunistic Infections ("CROI 2025"), we presented initial data from the multiple ascending dose (MAD) portion of our Phase 1/2 STRIVE trial of IMC-M113V, our functional cure candidate for HIV. The data included 16 people living with HIV (PLWH) who were stable on antiretrovial therapy (ART). While continuing ART, three sequential cohorts evaluated weekly IV infusions of IMC-M113V up to doses of 60 mcg (n=5), 120 mcg (n=5), and 300 mcg (n=6) administered over 12 weeks, followed by analytical treatment interruption for up to 12 weeks, after which participants resumed their prior ART regimen.

•All doses were well tolerated and no serious adverse events (“AEs”) or dose limiting toxicities were observed. Grade 1 cytokine release syndrome, consisting of fever alone that resolved within 4 hours, was observed in five of the six PLWH in the 300 mcg cohort when receiving their first 300 mcg dose. There were no discontinuations due to AEs. One person withdrew prior to completing the dose schedule in the 300 mcg cohort for reasons unrelated to IMC-M113V.

•In the 15 evaluable PLWH, delayed viral rebound and/or viremia control at any point during analytical treatment interruption was observed in 0 of 5 PLWH at 60 mcg, 1 of 5 PLWH at 120 mcg, and