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Alumis Impairs Lonigutamab as Envudeucitinib NDA Stays On Track

The company booked a $41.8 million IPR&D charge after deciding to explore strategic alternatives for lonigutamab, with cash of $502.3 million expected to fund operations into the fourth quarter of 2027.

Alumis Inc. (ALMS), a late-stage biopharmaceutical company developing oral tyrosine kinase 2 inhibitors, reported a $142.2 million net loss for the quarter ended June 30, 2026, after recording a $41.8 million impairment of the acquired in-process research and development asset tied to lonigutamab.

The company completed a strategic review of lonigutamab and decided to explore strategic alternatives for the asset. The decision was first disclosed in the first-quarter release; the second-quarter results carried the related impairment.

The year-ago quarter had shown net income of $59.3 million, which included a $187.9 million non-operating gain related to the merger with ACELYRIN, Inc.

Operating expenses for the quarter were $150.5 million. Research and development expenses were $85.3 million, down from $108.8 million a year earlier. The decrease was primarily driven by lower clinical trial and contract research costs after completion of enrollment and reporting of positive topline results for the pivotal Phase 3 ONWARD1 and ONWARD2 trials of envudeucitinib in plaque psoriasis in January 2026, and by the absence of ACELYRIN merger severance costs, partially offset by higher ONWARD3 trial costs and personnel expenses. General and administrative expenses were $23.4 million.

Collaboration revenue was $1.7 million, related to the Kaken Pharmaceutical agreement.

Cash, cash equivalents and marketable securities were $502.3 million as of June 30, 2026. Those balances are expected to fund operating expenses and capital expenditures into the fourth quarter of 2027.

Clinically, the quarter centered on long-term extension data for envudeucitinib. Topline results from ONWARD3 showed that 75% and 54% of patients achieved PASI 90 and PASI 100, respectively, after up to 48 weeks of continuous treatment in 773 patients, with a safety profile consistent with ONWARD1 and ONWARD2. President and Chief Executive Officer Martin Babler said the ONWARD3 long-term data delivered the highest reported PASI 100 response rate among oral therapies, positioning envudeucitinib to set a new standard in psoriasis.

Alumis remains on track to submit a New Drug Application to the FDA for envudeucitinib in moderate-to-severe plaque psoriasis in the fourth quarter of 2026. It also anticipates potentially pivotal Phase 2b LUMUS topline data for envudeucitinib in systemic lupus erythematosus in the third quarter of 2026.

Babler said the company is prioritizing Sjögren’s disease and cutaneous lupus erythematosus as the next indications for envudeucitinib, subject to LUMUS results and disciplined capital allocation. It plans to initiate a Phase 2 biomarker trial of A-005, its CNS-penetrant TYK2 inhibitor, in Parkinson’s disease in the first half of 2027. Alumis now expects to initiate a clinical trial for its next clinical candidate on a new target in 2027.

The company plans to present additional long-term envudeucitinib data at future medical meetings, and Phase 2 two-year safety data for envudeucitinib in psoriasis is expected in the second half of 2026.

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