Every material Form 8-K ALUMIS INC. has filed with the SEC since August 10, 2026, read and summarized by AI: what happened, the key figures, whether it reads positive or negative for shareholders, and how big a deal it is (impact 1-5). Newest first; each brief links to its own page and to the filing on SEC.gov.
Alumis said its Phase 2b LUMUS trial of envudeucitinib in systemic lupus erythematosus did not meet its primary or secondary endpoints in the overall population of 408 patients. The company highlighted a prespecified subgroup with high interferon gene signature, where responses were robust, and plans to engage regulators on Phase 3 development, while its planned NDA for psoriasis remains on track for the fourth quarter of 2026.
LUMUS enrolled 408 patients; the primary endpoint, BICLA at Week 48, was not met in the overall trial population.
In the prespecified IFNGS-high subgroup, BICLA response was 52.6% on 40mg twice-daily versus 28.6% on placebo.
Alumis plans an end-of-Phase 2 meeting with the FDA and EMA to discuss Phase 3 development in SLE.
The NDA for envudeucitinib in moderate-to-severe plaque psoriasis remains planned for the fourth quarter of 2026.
Alumis reported a net loss of $142.2 million for the quarter ended June 30, 2026, compared with net income of $59.3 million a year earlier, which included a $187.9 million non-operating gain tied to its ACELYRIN merger. The company took a $41.8 million impairment on the lonigutamab program after deciding to explore strategic alternatives for it, and reaffirmed that its $502.3 million in cash and marketable securities should fund operations into the fourth quarter of 2027.
Net loss of $142.2 million for the quarter, versus net income of $59.3 million a year earlier, which included a $187.9 million ACELYRIN merger gain.
Collaboration revenue of $1.7 million, down from $2.7 million a year earlier.
$41.8 million impairment loss on the acquired IPR&D intangible asset for the lonigutamab program.
Cash, cash equivalents and marketable securities of $502.3 million as of June 30, 2026; NDA submission for envudeucitinib in psoriasis planned for Q4 2026.
Alumis reported topline results from the ONWARD3 long-term extension study of envudeucitinib in plaque psoriasis, with 54% of patients reaching complete skin clearance (PASI 100) after 48 weeks of continuous treatment. The company said safety was consistent with prior data and that it remains on track to submit a New Drug Application to the FDA in the fourth quarter of 2026, which is the next key regulatory step for shareholders to watch.
54% of patients achieved PASI 100 and 75% achieved PASI 90 in the ONWARD3 NRI analysis of 773 patients treated for up to 48 weeks
An integrated NRI analysis across ONWARD1/2 and ONWARD3 of 890 patients showed 47% PASI 100 and 66% PASI 90 after 48 weeks
No new safety signals were observed, and the safety profile was consistent with ONWARD1/2
NDA submission planned for 4Q 2026; topline data from the LUMUS Phase 2b lupus trial expected in Q3 2026
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