Executives from Alumis (NASDAQ:ALMS) outlined recent clinical results, upcoming regulatory milestones, and pipeline priorities during a discussion at the Guggenheim Emerging Outlook Biotech Summit 2026.
Phase III psoriasis data highlights for envudeucitinib
President and CEO Martin Babler said Alumis is a “precision immunology company” focused on TYK2 as a genomically validated target. The company has multiple TYK2 inhibitors in clinical development, including a peripheral molecule and a brain-penetrant candidate.
He also emphasized a “fast onset,” noting separation on PASI 90 and PASI 75 by week 4, and said the safety profile was consistent with Phase II, with no new safety signals. Babler said the company believes envudeucitinib is competitive in the oral psoriasis market not only on lesion reduction but also on measures tied to quality of life, including itch resolution.
Why Alumis shared limited topline details
Asked why the company disclosed only select endpoints at different time points, Babler said medical societies have become more restrictive about late-breaking presentations, and Alumis wanted to preserve the opportunity for a late breaker at the American Academy of Dermatology (AAD) meeting. He said the company sought to balance limited disclosure with providing enough information for physicians and investors.
Babler said PASI 75 at week 16 is the trial’s primary endpoint and was shared. He added that physicians often focus on PASI 90 and PASI 100 at week 24 when assessing therapies, which influenced the company’s disclosure choices. He said the company also aimed to communicate speed of onset and safety while still holding back full details.
On placebo response, Babler said PASI 90 and PASI 100 placebo rates were in line with recent trials, describing PASI 90 as below 5% and PASI 100 as around 1% or lower. For PASI 75, he said one of Alumis’ trials had a higher placebo rate (as well as higher active and comparator rates), but the results were consistent after adjustment.
Market outlook: expectations for oral psoriasis growth
Babler argued that patient preference could expand the oral psoriasis segment. He said more patients are currently treated with oral drugs than injectables, and an even larger group uses topical therapies. He cited market research indicating about 75% of psoriasis patients would prefer a pill over an injectable or topical.
According to Babler, Alumis expects some patients currently on topicals—particularly those with relatively high body surface area involvement—to switch to oral therapies, potentially keeping patients on oral drugs longer and positioning injectables as more of a “backup plan.” He suggested patient subgroups, such as those with scalp involvement where itch is a significant concern, could influence product choice as additional oral TYK2 options emerge.
Regulatory timing and commercialization planning
On next steps, Babler said Alumis has guided to a new drug application (NDA) filing in the second half of this year. He described the key path item as generating durability and maintenance data for the label, which depends on completing a randomized withdrawal component within ONWARD 3, the long-term extension study. He said data from that withdrawal portion should be available in the second quarter to early third quarter, after which the company plans to finalize the NDA.
Babler said additional readouts expected later this year include 48-week long-term data and other datasets such as biomarker results and “special area” data.
On commercial readiness, Babler said Alumis currently has the capability to conduct pre-launch preparation, including an active medical science liaison (MSL) team, medical affairs, and commercial functions. While he said the company could potentially launch on its own, he framed the larger strategic question as optimizing a broader TYK2 franchise across “up to 20 different indications,” which he said may make a partnership more likely, particularly for a global multi-indication approach.
Pipeline priorities: lupus and a brain-penetrant TYK2 for MS
Babler described systemic lupus erythematosus (SLE) as an attractive opportunity for TYK2, citing genomic support and prior clinical and mechanistic validation. He referenced a protective TYK2-related mutation (P1104A) and said people with that mutation are protected from lupus “almost as well” as from psoriasis. He also pointed to positive effects reported across doses of deucravacitinib in lupus and described anifrolumab as validating the interferon mechanism.
Alumis expects results in the third quarter of this year from its Phase IIb lupus study, which Babler described as designed as a pivotal trial. He said execution priorities include:
- Enrolling appropriate patients using an adjudication panel to ensure active disease and relevant symptoms.
- Managing concomitant medications, including a steroid taper; patients unable to taper steroids are considered non-responders.
- Improving data quality via continuous review for discrepancies and repeated site retraining.
He also said Alumis selected BICLA as the primary endpoint, citing its graded assessment and its ability to capture skin manifestations, which he said are relevant for TYK2 inhibitors.
On expectations for placebo and success criteria, Babler said placebo response rates in lupus trials can range from 20% to 60%, and Alumis hopes to be on the lower end. He said a successful outcome would be “mid-teens” improvement comparable to anifrolumab, which he characterized as about 15%.
Babler said the lupus study includes more than 400 patients, with about 100 patients in the winning group, and that the company’s base case assumes one additional Phase III study would be needed, though “outstanding” results could potentially change that.
For its brain-penetrant TYK2 program, Babler said Alumis intends to start an RMS (multiple sclerosis) study in the first half of this year. He said preclinical work suggests a strong anti-inflammatory effect in the EAE model and described a potential combination of microglial effects (linked to disability) and anti-inflammatory effects (linked to relapse rates). He also said the second molecule could provide flexibility around pricing and timing and may support additional indications beyond MS.
Chief Financial Officer John Schroer said Alumis entered the year with cash plus proceeds from a follow-on offering totaling “just over $630 million,” which he said provides runway into the fourth quarter of 2027.
About Alumis (NASDAQ:ALMS)
Our mission is to significantly improve the lives of patients by replacing broad immunosuppression with targeted therapies. Our name, Alumis, captures our mission to enlighten immunology, and is inspired by the words “allumer”-French for illuminate-and “immunis”-Latin for the immune system. We are a clinical stage biopharmaceutical company with an initial focus on developing our two Tyrosine Kinase 2 (TYK2) inhibitors: ESK-001, a second-generation inhibitor that we are developing to maximize target inhibition and optimize tolerability, and A-005, a central nervous system (CNS) penetrant molecule.
