Company: IMCR
Filing Date: 2025-05-07
Form Type: 10-Q
Source: 0001671927-25-000009
Chunk: 36

Company: Immunocore Holdings plc
Filing Date: 2025-05-07
Form: 10-Q
Item: Part I, Item 1
Chunk 36
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 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 2 of 5 PLWH at 300 mcg. The 3 PLWH with evidence of viral control had a viral load of approximately 200 c/mL at week 8. The historical rate for this observation is 5%. Furthermore, 2 of these 3 PLWH remained off ART for the entire 12 week analytical treatment interruption period that was pre-specified in the protocol.

•In the 3 PLWH with evidence of viral control, the pattern consisted of initial viral rebound followed by viral reduction to approximately 200 c/mL, including 1 PLWH at 300 mcg who had initial viremia to >104 c/mL before subsequent decrease to <50 c/mL at week 12. Such ‘