-- Positive Phase 3 topline results demonstrating envudeucitinib's leading skin clearance, meaningful symptom improvement and a favorable safety profile in patients with moderate-to-severe plaque psoriasis (PsO) --
-- Plan to submit NDA for envudeucitinib in PsO in 2H 2026 --
-- Potentially pivotal Phase 2b clinical topline data for envudeucitinib in systemic lupus erythematosus $(SLE)$ anticipated 3Q 2026 --
-- Presentation of additional Phase 3 ONWARD1 and ONWARD2 data at AAD 2026 --
-- Completed an upsized public offering raising $345.1 million in gross proceeds in Jan 2026 --
SOUTH SAN FRANCISCO, Calif., March 19, 2026 (GLOBE NEWSWIRE) -- Alumis Inc. (Nasdaq: ALMS), a late-stage biopharma company developing next-generation targeted therapies for patients with immune-mediated diseases, today reported financial results for the year ended December 31, 2025, and highlighted recent achievements and upcoming milestones.
"Alumis concluded a pivotal year marked by strong execution and the Phase 3 clinical validation of envudeucitinib in moderate-to-severe plaque psoriasis, underscoring the promise of TYK2 inhibition and envudeucitinib's highly differentiated clinical profile," said Martin Babler, President and Chief Executive Officer of Alumis. "By maximally inhibiting TYK2 to block both IL-23 and IL-17 pathways, envudeucitinib delivered comprehensive disease control with rapid onset of action, high rates of skin clearance, and meaningful symptom improvements in our Phase 3 ONWARD program that reinforce our conviction in envudeucitinib's potential to transform the psoriasis treatment landscape. We look forward to our clinical topline readout for our potentially pivotal LUMUS Phase 2b trial in SLE, anticipated in the third quarter of this year."
Babler added, "Importantly, the results of both psoriasis and SLE will potentially unlock envudeucitinib's pipeline--in--a--pill' opportunity to leverage maximal TYK2 inhibition across multiple immune--mediated diseases. Alumis is evaluating additional indications for our TYK2 inhibitors as part of a unified franchise development strategy that we plan to announce in the second quarter of 2026."
Fourth Quarter 2025 and Recent Highlights
-- Positive topline results from Phase 3 ONWARD1 and ONWARD2 clinical trials
of envudeucitinib, a next-generation highly selective oral tyrosine
kinase 2 (TYK2) inhibitor, in patients with moderate-to-severe plaque
psoriasis
-- Both Phase 3 trials met all primary and secondary endpoints with
high statistical significance in patients with moderate-to-severe
plaque psoriasis
-- Envudeucitinib showed leading skin clearance for oral plaque
psoriasis therapies, with approximately 65% of patients achieving
PASI 90 and more than 40% achieving PASI 100 at Week 24, on
average
-- Envudeucitinib demonstrated a favorable safety and tolerability
profile consistent with the Phase 2 program
-- Completed closing of its upsized underwritten public offering of
20,297,500 shares of its common stock, including the full exercise of the
underwriters' option to purchase an additional 2,647,500 shares, at a
price to the public of $17.00 per share
-- Gross proceeds to Alumis from the offering, before deducting
underwriting discounts and commissions and offering expenses, were
approximately $345.1 million
-- TYK2 Pipeline Update
-- Given the strength and insights from the Phase 3 envudeucitinib
data in PsO and the Phase 2 readiness of A--005, Alumis is
well-positioned to expand the potential of its TYK2 pipeline.
-- Alumis is currently evaluating additional immune--mediated disease
indications for envudeucitinib beyond PsO and SLE, and for its
A--005 program in central nervous system $(CNS)$ and peripheral
diseases, under a unified TYK2 franchise development strategy.
-- Alumis will provide an update of the TYK2 franchise strategy for
both programs in the second quarter of 2026, including a timing
update for commencing A--005's Phase 2 trial.
Anticipated 2026 Milestones
-- Envudeucitinib in Moderate-to-Severe Plaque Psoriasis
-- Late-breaking oral presentation of additional Phase 3 data
(ONWARD1 and ONWARD2) at the American Academy of Dermatology (AAD)
Annual Meeting taking place March 27-31 in Denver, CO
-- Company management to participate in a virtual key opinion leader
$(KOL)$ event featuring leading dermatology and psoriasis expert Dr.
Andrew Blauvelt, to discuss results from the Phase 3 ONWARD
program that were presented at AAD
-- Long-term data - ONWARD3 topline data and Phase 2, two-year safety
data (2H 2026)
-- NDA submission (2H 2026)
-- Envudeucitinib in SLE
-- Potentially pivotal Phase 2b SLE topline data (3Q 2026)
-- TYK2 Franchise
-- Update on unified TYK2 franchise development strategy, including
evaluation of additional indications (2Q 2026)
-- Lonigutamab
-- Completion of strategic review (1H 2026)
-- Next clinical candidate (new target)
-- Initiate Phase 1 trial (2H 2026)
Year-end 2025 Financial Results
-- As of December 31, 2025, Alumis had cash, cash equivalents and marketable
securities of $308.5 million.
-- Revenue included license revenue of $17.4 million and collaboration
revenue of $6.7 million for the year ended December 31, 2025, related to
the collaboration and licensing agreement with Kaken Pharmaceutical Co.,
Ltd.
-- Research and development expenses were $386.0 million for the year ended
December 31, 2025, compared to $265.6 million for the year ended
December 31, 2024. The increase was primarily driven by contract research
and clinical trial costs for the envudeucitinib and other programs,
including costs to support acceleration of clinical trial activities for
the Phase 3 ONWARD clinical program, as well as increased headcount to
support development e orts and severance costs, including stock-based
compensation expense, related to the merger with ACELYRIN. The year ended
December 31, 2024 included a clinical milestone payment of $23.0 million
related to the prior acquisition of FronThera.
-- General and administrative expenses were $91.9 million for the year ended
December 31, 2025, compared to $35.2 million for the year ended
December 31, 2024. The increase was primarily attributable to transaction
and severance costs, including stock-based compensation expense, related
to the merger with ACELYRIN, as well as increased headcount and
professional consulting services to support the Company's growth.
-- Net loss was $243.3 million for the year ended December 31, 2025,
compared to a net loss of $294.2 million for the year ended
December 31, 2024.
-- The Company recognized total expenses related to the merger with ACELYRIN
of $39.7 million for the year ended December 31, 2025, of which $30.2
million related to general and administrative expenses for the year ended
December 31, 2025, and $9.5 million related to research and development
expenses for the year ended December 31, 2025. These merger-related
expenses included stock-based compensation expense of $13.1 million for
the year ended December 31, 2025, related to accelerated vesting of
equity awards and a stock option post-termination exercise period
modification for severed employees.
Financial Guidance
-- Based on the Company's current operating plan, Alumis continues to
anticipate that its existing cash, cash equivalents and marketable
securities as of December 31, 2025, as well as net proceeds of $324.4
million, after underwriting discounts and commissions, from its public
offering of common stock in January 2026, is expected to fund operating
expenses and capital expenditure requirements into the fourth quarter of
2027.
About Alumis
Alumis is a late-stage biopharma company developing next-generation targeted therapies with the potential to significantly improve patient health and outcomes across a range of immune-mediated diseases. Leveraging its proprietary data analytics platform and precision approach, Alumis is developing a pipeline of oral tyrosine kinase 2 inhibitors, consisting of envudeucitinib, formerly known as ESK-001, for the treatment of systemic immune-mediated disorders, such as moderate-to-severe plaque psoriasis and systemic lupus erythematosus, and A-005 with neuroinflammatory, neurodegenerative and peripheral immune-mediated disease indications under evaluation. In addition, the pipeline includes lonigutamab, a subcutaneously delivered anti--insulin-like growth factor 1 receptor therapy for the treatment of thyroid eye disease, as well as several preclinical programs identified through this precision approach. For more information, visit www.alumis.com or follow us on LinkedIn or X.
Forward Looking Statements
(MORE TO FOLLOW) Dow Jones Newswires
March 19, 2026 16:05 ET (20:05 GMT)
