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Alumis Narrows Third-Quarter Net Loss, Keeps Psoriasis NDA Plan

The late-stage biopharma posted $1.9 million in collaboration revenue and a $94.9 million net loss for the third quarter of 2026, with $431.3 million in cash, cash equivalents and marketable securities, as it kept a fourth-quarter NDA filing for envudeucitinib in plaque psoriasis on track.

Alumis Inc. (ALMS), a late-stage biopharmaceutical company developing oral TYK2 inhibitors for immune-mediated disease, reported collaboration revenue of $1.9 million for the quarter ended September 30, 2026, compared with $2.1 million a year earlier. Net loss narrowed to $94.9 million from $110.8 million. The company said the Phase 2b LUMUS trial of envudeucitinib in moderate-to-severe systemic lupus erythematosus did not meet its primary and secondary endpoints in the overall trial population.

The company said robust clinical responses were observed in a prespecified subgroup of patients with a high interferon gene signature, including on the primary BICLA endpoint and on CLASI-50, SRI-4 and LLDAS. It said IFNGS-high patients represent the majority of moderate-to-severe SLE cases and were unexpectedly under-represented in LUMUS, reducing response rates in the overall population. Pharmacodynamic data confirmed dose-dependent interferon-pathway target engagement, with maximal suppression at 40 mg twice daily. Envudeucitinib was well tolerated, with no new safety signals. Alumis plans end-of-Phase 2 regulatory interactions and said it will evaluate development options.

In plaque psoriasis, the company remained on track to submit a New Drug Application for envudeucitinib in moderate-to-severe disease in the fourth quarter of 2026, and to present Phase 2 two-year safety data in that same period. President and Chief Executive Officer Martin Babler said new data presented in October showed early and durable improvement across scalp disease severity, itch resolution and quality-of-life measures, building on a 54% PASI 100 response rate at 48 weeks.

Those October data, from the 26th Annual Fall Clinical Dermatology Conference, added to the ONWARD program. More than 80% of patients in ONWARD3 maintained clear or almost clear scalp skin at 48 weeks. In ONWARD1/2, about one-third of patients achieved a four-point or greater itch reduction as early as Week 2; by Week 16, about 40% reached complete itch resolution and approximately 60% reported minimal or no itch. Nearly 80% of ONWARD3 patients sustained clinically meaningful itch reduction through Week 48. About 50% of ONWARD1/2 patients reached a DLQI of 0 or 1 by Week 12, and more than 70% of ONWARD3 patients maintained DLQI 0/1 at 48 weeks. Patients who crossed over from placebo or apremilast achieved improvements comparable to those continuously treated at Week 48.

For the quarter ended September 30, 2026, collaboration revenue was $1.9 million, compared with $2.1 million a year earlier, related to the Kaken Pharmaceutical collaboration. Research and development expenses were $80.8 million, versus $97.8 million a year earlier. The company said the decrease was primarily driven by lower clinical trial and contract research costs after completion of the pivotal ONWARD1 and ONWARD2 trials, partially offset by higher ONWARD3 costs. General and administrative expenses were $20.2 million, compared with $19.5 million a year earlier, which the company attributed primarily to launch-preparation and personnel costs, partially offset by 2025 severance, ACELYRIN merger and legal costs.

Net loss was $94.9 million for the quarter, compared with a net loss of $110.8 million a year earlier. Cash, cash equivalents and marketable securities were $431.3 million as of September 30, 2026. Based on its current operating plan, Alumis continues to anticipate that existing cash, cash equivalents and marketable securities as of September 30, 2026 are sufficient to fund operating expenses and capital expenditure into the fourth quarter of 2027.

Alumis also said it plans to initiate a Phase 2 biomarker trial for A-005, its CNS-penetrant TYK2 inhibitor, in Parkinson’s disease in 2027. A Phase 1 healthy-volunteer study showed the compound was well tolerated, achieved maximal peripheral target inhibition and penetrated the CNS.

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