-- ONWARD3: 54% of patients reached complete skin clearance (PASI 100) at 48 weeks, positioning envudeucitinib to set a new standard in PsO --
-- Alumis remains on track to submit its New Drug Application to FDA for envudeucitinib in moderate-to-severe plaque psoriasis (PsO) in Q4 2026 --
-- Potentially pivotal Phase 2b LUMUS topline data for envudeucitinib in SLE anticipated in Q3 2026 --
SOUTH SAN FRANCISCO, Calif., Aug. 13, 2026 (GLOBE NEWSWIRE) -- Alumis Inc. (Nasdaq: ALMS), a late-stage biopharmaceutical company developing next-generation targeted therapies for patients with immune-mediated diseases, today reported financial results for the quarter ended June 30, 2026, and highlighted recent achievements and upcoming milestones.
"Envudeucitinib's Phase 3 clinical validation in PsO, reinforced by our ONWARD3 long-term data, demonstrates the power of maximal TYK2 inhibition in IL-23/IL-17-driven diseases, and our anticipated Phase 2b LUMUS readout in SLE may substantiate its role in IFN-driven diseases -- potentially unlocking broader potential of our TYK2 franchise," said Martin Babler, President and Chief Executive Officer of Alumis. "The ONWARD3 long-term data delivered the highest reported PASI 100 response rate among oral therapies, positioning envudeucitinib to set a new standard in PsO. We remain on track to submit a New Drug Application for envudeucitinib in moderate-to-severe plaque psoriasis in Q4 with the goal, if approved, of bringing this new oral treatment option to patients."
"Looking ahead, our main focus is on realizing our two TYK2 pipeline-in-a-pill franchise opportunities." Babler added, "Based on the strength of clinical data to date, we are prioritizing Sjögren's disease and cutaneous lupus erythematosus (CLE) as the next indications for envudeucitinib, subject to our LUMUS results and disciplined capital allocation. We are also advancing A-005, our CNS-penetrant TYK2 inhibitor, into a Phase 2 biomarker trial in Parkinson's disease patients, planned to be initiated in the first half of 2027. Collectively, these programs underscore our goal to leverage the breadth of the TYK2 mechanism to pursue a broad range of immune-mediated diseases."
Second Quarter 2026 and Recent Highlights
Envudeucitinib: a next-generation, highly selective oral tyrosine kinase 2 (TYK2) inhibitor, in patients with moderate-to-severe plaque psoriasis
-- Topline results from the ongoing ONWARD3 long-term extension study showed
that 75% and 54% of patients achieved PASI 90 and PASI 100, respectively,
after up to 48 weeks of continuous envudeucitinib treatment (n=773), with
envudeucitinib well tolerated and a safety profile consistent with
ONWARD1/2 (LINK TO PR).
-- Alumis remains on track to submit its New Drug Application to FDA for
envudeucitinib in PsO in the fourth quarter of 2026.
-- Alumis plans to present additional long-term envudeucitinib data at
future medical meetings.
Envudeucitinib: Systemic Lupus Erythematosus $(SLE)$
-- Alumis anticipates potentially pivotal Phase 2b LUMUS topline data for
envudeucitinib in SLE in the third quarter of 2026, a milestone with the
potential to open the Type I interferon disease pathway for the TYK2
franchise.
TYK2 Franchise and Pipeline Update
-- Alumis is prioritizing Sjögren's disease and cutaneous lupus
erythematosus (CLE) as additional interferon-driven indications to pursue
for envudeucitinib. Advancement decisions will depend on LUMUS Phase 2b
results and disciplined capital allocation.
-- Alumis plans to initiate a Phase 2 biomarker trial for A-005, its central
nervous system penetrant TYK2 inhibitor, in patients with Parkinson's
disease, in the first half of 2027. In a Phase 1 healthy volunteer study,
A-005 was well-tolerated, achieved maximal target inhibition in the
periphery and demonstrated the ability to penetrate into the central
nervous system.
-- Alumis completed its strategic review of the lonigutamab program and
decided to explore strategic alternatives for this asset.
Anticipated 2026 Milestones
-- Envudeucitinib in Moderate-to-Severe Plaque Psoriasis
-- Long-term data: Phase 2, two-year safety data (2H 2026)
-- NDA submission (4Q 2026)
-- Envudeucitinib in SLE
-- Potentially pivotal Phase 2b SLE topline data (3Q 2026)
-- A-005
-- Initiation of Phase 2 biomarker trial in Parkinson's disease (1H
2027)
-- Next clinical candidate (new target)
-- Alumis now expects to initiate a clinical trial for the next
clinical candidate in 2027
Second Quarter 2026 Financial Results
-- As of June 30, 2026, Alumis had cash, cash equivalents and marketable
securities of $502.3 million.
-- Revenue included collaboration revenue of $1.7 million for the quarter
ended June 30, 2026, compared to collaboration revenue of $2.7 million
for the quarter ended June 30, 2025, related to the collaboration and
licensing agreement with Kaken Pharmaceutical Co., Ltd.
-- Research and development expenses were $85.3 million for the quarter
ended June 30, 2026, compared to $108.8 million for the quarter ended
June 30, 2025. The decrease was primarily driven by lower clinical trial
and contract research costs following completion of enrollment and
reporting of positive topline results for the pivotal Phase 3 ONWARD1 and
ONWARD2 clinical trials of envudeucitinib in patients with PsO in January
2026 and severance costs related to the merger with ACELYRIN, Inc. in the
quarter ended June 30, 2025, partially offset by an increase in clinical
trial and contract research costs for the Phase 3 ONWARD3 clinical trial
and an increase in personnel-related expenses for the quarter ended June
30, 2026.
-- General and administrative expenses were $23.4 million for the quarter
ended June 30, 2026, compared to $34.5 million for the quarter ended
June 30, 2025. The decrease was primarily attributable to severance and
transaction costs related to the merger with ACELYRIN, Inc. in the
quarter ended June 30, 2025, partially offset by legal expenses and other
costs and an increase in personnel-related expenses for the quarter ended
June 30, 2026.
-- Operating expenses for the quarter ended June 30, 2026 included a $41.8
million impairment loss related to the acquired IPR&D intangible asset
associated with the lonigutamab program following the Company's decision
to pursue strategic alternatives for the program.
-- Net loss was $142.2 million for the quarter ended June 30, 2026, compared
to net income of $59.3 million for the quarter ended June 30, 2025, which
included a non-operating gain of $187.9 million related to the merger
with ACELYRIN, Inc.
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 June 30, 2026 are expected to fund operating expenses
and capital expenditure requirements into the fourth quarter of 2027.
About Alumis
Alumis is a late-stage biopharmaceutical 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, its central nervous system penetrant TYK2 inhibitor, with initial development focused on Parkinson's disease and additional neuroinflammatory, neurodegenerative and peripheral immune-mediated disease indications under evaluation. For more information, visit www.alumis.com or follow us on LinkedIn or X.
Forward-Looking Statements
This press release contains forward-looking statements within the meaning of federal securities laws, including the "safe harbor" provisions of the Private Securities Litigation Reform Act of 1995. These statements may be identified by words such as "anticipates," "believes," "plans," "seeks," "will" and variations of these words or similar expressions that are intended to identify forward-looking statements. All statements, other than statements of historical facts, including without limitation those regarding the timing of the initiation of clinical trials, including a Phase 1 trial for the Company's next clinical candidate, the timing and results of clinical data readouts in its ongoing clinical trials, including the Company's Phase 2b LUMUS trial in systemic lupus erythematosus, as well as long-term and safety data in moderate-to-severe plaque psoriasis (PsO), the timing of the Company's planned NDA submission with the FDA for envudeucitinib in PsO, the Company's plans to prioritize Sjögren's disease and cutaneous lupus erythematosus as additional indications for envudeucitinib, the Company's goal to bring a new oral treatment option to patients with PsO and pursue a broad range of immune-mediated diseases, the timing of the Company's planned Phase 2 biomarker trial for A-005 in Parkinson's disease, the potential for envudeucitinib to treat PsO, the potential for envudeucitinib to reshape the psoriasis treatment landscape, systemic lupus erythematosus and other immune-mediated diseases and/or to realize TYK2 franchise pipeline-in-a-pill opportunities, the Company's plans to explore strategic alternatives for lonigutamab, any expectations regarding the safety, efficacy or tolerability of its drug candidates and statements regarding Alumis' future plans and prospects,