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Alumis Reports Year End 2024 Financial Results and Highlights Recent Achievements

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Alumis Inc.
Alumis Inc.

– Presented Phase 2 STRIDE OLE 52-week psoriasis data at AAD 2025 demonstrating next-generation oral TYK2 inhibitor ESK-001 treatment led to robust long-term clinical responses and was well tolerated; Phase 3 ONWARD program data readout now expected 1Q 2026 –

– Presented Phase 1 clinical data at ACTRIMS 2025 demonstrating first-in-class oral TYK2 inhibitor A-005 has ability to cross blood-brain barrier and was well tolerated; Phase 2 in MS to begin 2H 2025 –

– Announced merger agreement with ACELYRIN to create combined company with differentiated late-stage portfolio of therapies and strong balance sheet; expected to close 2Q 2025 –

SOUTH SAN FRANCISCO, Calif., March 19, 2025 (GLOBE NEWSWIRE) -- Alumis Inc. (Nasdaq: ALMS), a clinical-stage biopharmaceutical company developing oral therapies using a precision approach to optimize clinical outcomes and significantly improve the lives of patients with immune-mediated diseases, today reported financial results for the year ended December 31, 2024, and highlighted recent achievements and upcoming milestones.

“Alumis concluded a strong 2024, continuing to establish our late-stage pipeline of next-generation oral TYK2 inhibitors that have the potential to address significant unmet patient needs in immune-mediated diseases around the world,” said Martin Babler, President and Chief Executive Officer of Alumis. “The next 12-18 months will bring major milestones for Alumis, with topline data from the pivotal Phase 3 program for ESK-001 in moderate-to-severe plaque psoriasis expected in the first quarter of 2026. We also plan to initiate a Phase 2 trial of A-005 in multiple sclerosis in the second half of 2025 and expect data from ESK-001’s Phase 2b clinical trial in systemic lupus erythematosus in 2026. Together, these milestones underscore the importance of this time period as transformative in Alumis’ long-term growth strategy.”

Babler added “The announcement of the merger agreement with ACELYRIN represents a significant step forward in Alumis' strategic progress that will create a leading immunology and inflammation company with multiple upcoming expected development milestones and extend our runway into 2027. We look forward to the anticipated close of the transaction in the second quarter.”

Fourth Quarter 2024 and Recent Highlights

  • Presented late-breaking long-term 52-week data at AAD 2025 for ESK-001, a highly selective, next-generation oral tyrosine kinase 2 (TYK2) inhibitor, supporting its potential to offer a differentiated and best-in-class treatment profile for people with moderate-to-severe plaque psoriasis:

    • Phase 2 STRIDE OLE Week 52 data of ESK-001 40 mg BID demonstrated sustained or increasing clinical responses throughout week 52 on PASI 90, PASI 100 and sPGA 0; favorable safety and tolerability profile at one year remains consistent with previously reported data.

    • The Phase 3 ONWARD program for ESK-001 consists of two parallel 24-week global Phase 3 clinical trials (ONWARD1 and ONWARD2) designed to evaluate the efficacy and safety of ESK-001 in adult patients with moderate-to-severe plaque psoriasis and also includes a long-term extension (LTE) trial, ONWARD3, designed to evaluate durability and maintenance of response and long-term safety. Topline results are anticipated in the first quarter of 2026.

  • Presented data highlighting ESK-001 potential as a high-efficacy oral treatment for systemic lupus erythematosus (SLE) at ACR Convergence 2024.

    • Data demonstrated that ESK-001 suppresses key cytokines and disease biomarkers of SLE.

    • The Phase 2b LUMUS clinical trial for ESK-001 in patients with SLE is ongoing with topline data expected in 2026.

  • Presented positive Phase 1 data for A-005 a potent, selective, central nervous system (CNS) penetrant TYK2 inhibitor, in healthy participants.

    • A-005 was well tolerated and demonstrated ability to cross blood-brain barrier; maximal TYK2 inhibition achieved with favorable pharmacokinetic profile in CNS and periphery across a range of doses tested.

    • Data support planned initiation of Phase 2 clinical trial in multiple sclerosis in 2H 2025.

  • Announced definitive agreement to merge with ACELYRIN Inc. (ACELYRIN) in an all-stock transaction that will create a combined company benefitting from a differentiated late-stage portfolio of therapies and increased financial flexibility that is expected to provide cash runway into 2027.

    • Alumis and ACELYRIN had cash, cash equivalents, restricted cash and marketable securities of approximately $289 million and approximately $448 million, respectively, as of December 31, 2024. With a pro forma cash position of approximately $737 million as of December 31, 2024, and continued operating discipline, Alumis expects that this cash position provides runway to advance the combined company’s pipeline through multiple planned key data readouts across several clinical trials and to fund operating expenses and capital expenditure requirements into 2027.

    • Upon the close of the transaction, Alumis stockholders will own approximately 55% of the combined company and ACELYRIN stockholders will own approximately 45% of the combined company, on a fully diluted basis.

    • The transaction, which was unanimously recommended and approved by the disinterested directors of each company’s Board, is expected to close in the second quarter of 2025, subject to approval by the stockholders of both companies and satisfaction of other customary closing conditions.

  • Strengthened leadership team with key appointments supporting transition to late-stage company.

    • Jack Danilkowicz was appointed as Chief Commercial Officer bringing extensive experience successfully planning and executing commercial strategies at global biopharmaceutical companies.

    • Sara Klein was promoted to Chief Legal Officer leveraging deep expertise advising biopharmaceutical companies on legal matters across all stages of development and growth.


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