Company Description
Alumis Inc. (Nasdaq: ALMS) is a late-stage, clinical-stage biopharmaceutical company focused on developing next-generation targeted therapies for patients with immune-mediated diseases. The company is described in its public communications as a biopharma organization advancing a pipeline of precision medicines designed to address immune dysregulation across a range of conditions.
Alumis is based in South San Francisco, California and its common stock is listed on The Nasdaq Global Select Market under the trading symbol ALMS, as disclosed in its SEC filings. The company characterizes itself as a late-stage biopharma or clinical-stage biopharmaceutical company in multiple press releases, reflecting the advanced status of several of its development programs.
Precision immunology focus
According to Alumis’ press releases, the company is developing next-generation targeted therapies with the stated potential to significantly improve patient health and outcomes across a range of immune-mediated diseases. Alumis reports that it leverages a proprietary data analytics platform and a precision approach to identify and advance programs that target key drivers of immune-mediated conditions.
The company’s communications describe a focus on tyrosine kinase 2 (TYK2) inhibition and other targeted mechanisms that aim to correct immune dysregulation. Alumis highlights the use of precision data analytics and biological insights to support its research and development activities and to identify additional preclinical programs.
Lead program: Envudeucitinib (envu, formerly ESK-001)
Alumis identifies envudeucitinib (also referred to as envu and formerly known as ESK-001) as a next-generation, highly selective, oral allosteric inhibitor of TYK2. Company disclosures state that envudeucitinib is designed to correct immune dysregulation across diseases driven by proinflammatory mediators, including IL‑23, IL‑17 and Type I interferon.
In plaque psoriasis, Alumis reports that envudeucitinib is being evaluated in the Phase 3 ONWARD clinical program in adults with moderate-to-severe plaque psoriasis. The ONWARD program includes two global, multi‑center, randomized, double‑blind, placebo- and active-comparator‑controlled 24‑week trials (ONWARD1 and ONWARD2), with an optional long‑term extension study (ONWARD3) to assess durability, maintenance of response and long‑term safety. Company communications describe envudeucitinib as a next-generation oral TYK2 inhibitor for systemic immune-mediated disorders, such as moderate-to-severe plaque psoriasis and systemic lupus erythematosus.
Alumis has announced positive topline results from the ONWARD1 and ONWARD2 Phase 3 trials in moderate-to-severe plaque psoriasis. In these disclosures, the company reports that envudeucitinib met all primary and secondary endpoints with high statistical significance compared with placebo, achieved high rates of skin clearance on Psoriasis Area and Severity Index (PASI) and static Physician’s Global Assessment (sPGA) measures, and demonstrated a safety and tolerability profile described as consistent with prior Phase 2 experience. Alumis also notes that envudeucitinib achieved superior skin clearance compared with apremilast on PASI endpoints at Week 24 in these trials.
In systemic lupus erythematosus (SLE), Alumis is conducting the global LUMUS Phase 2b trial of envudeucitinib (also described in earlier communications as ESK-001). The company states that LUMUS is a randomized, double‑blind, placebo‑controlled study in adults with moderately-to-severely active, autoantibody‑positive SLE, evaluating multiple doses over 48 weeks, with the primary endpoint based on the British Isles Lupus Assessment Group-based Composite Lupus Assessment (BICLA). Alumis has announced completion of patient enrollment in LUMUS and has indicated that topline data are expected in a future period, as described in its press releases.
Additional TYK2 program: A-005
Alumis describes A‑005 as a potentially first‑in‑class, fully CNS‑penetrant oral TYK2 inhibitor for the treatment of neuroinflammatory and neurodegenerative diseases. Company updates state that A‑005 is being advanced toward a Phase 2 clinical trial in multiple sclerosis, supported by pharmacokinetic, pharmacodynamic and central nervous system penetration data presented at a scientific congress. Alumis reports that A‑005 has demonstrated maximal TYK2 inhibition, the ability to cross the blood–brain barrier, and a favorable tolerability profile in the data it has shared.
In its corporate updates, Alumis notes that CMC and pharmacology activities for A‑005 are ongoing, and that preclinical and genetic research efforts are being used to support potential expansion into additional neurodegenerative indications. The company also indicates that resource allocation to support envudeucitinib clinical trial enrollment has influenced the timing of A‑005 program milestones.
Lonigutamab and other pipeline programs
Beyond its TYK2 inhibitors, Alumis is developing lonigutamab, which it describes as a next‑generation subcutaneously delivered anti–insulin-like growth factor 1 receptor (IGF‑1R) therapy for the treatment of thyroid eye disease (TED). Company disclosures note that lonigutamab is administered subcutaneously and that the U.S. Food and Drug Administration has granted Fast Track Designation to lonigutamab for TED. Alumis has reported Phase 1/2 proof‑of‑concept data in TED, including safety, efficacy and quality‑of‑life outcomes, through scientific presentations.
Alumis also refers to several preclinical programs identified through its precision approach and proprietary data analytics platform. These additional programs are described as targeting key drivers of immune-mediated diseases, with at least one internally developed program expected to generate Phase 1 clinical data in a future period, according to the company’s guidance.
Corporate and capital markets activity
Alumis has reported multiple corporate developments in its public filings and press releases. The company completed a merger with ACELYRIN, Inc., with ACELYRIN becoming a wholly owned subsidiary of Alumis. Alumis has stated that this merger strengthened its balance sheet and supports advancement of its late-stage immunology pipeline. The company has also disclosed collaboration revenue related to a collaboration and licensing agreement with Kaken Pharmaceutical Co., Ltd.
On the capital markets side, Alumis has announced an upsized underwritten public offering of its common stock and the subsequent closing of that offering, with all shares sold by the company. These offerings were conducted under a shelf registration statement on Form S‑3 that was declared effective by the SEC, as described in the related press releases. Alumis has also indicated that it participates regularly in healthcare and investor conferences hosted by financial institutions and investment banks.
Regulatory status and exchange listing
According to its Form 8‑K filings, Alumis Inc. is incorporated in Delaware and its common stock, with a par value of $0.0001 per share, is registered under Section 12(b) of the Securities Exchange Act of 1934 and listed on The Nasdaq Global Select Market under the symbol ALMS. The company identifies itself as an emerging growth company in certain SEC filings.
Business model and disease areas
Based on its own descriptions, Alumis’ business model centers on discovering, developing and advancing targeted therapies for immune-mediated diseases. The company’s communications emphasize a precision immunology research and development platform, with a focus on TYK2 inhibition and other targeted mechanisms. Alumis highlights disease areas such as moderate-to-severe plaque psoriasis, systemic lupus erythematosus, neuroinflammatory and neurodegenerative diseases (including multiple sclerosis), and thyroid eye disease.
In its press releases, Alumis notes that plaque psoriasis is a chronic, immune-mediated disease driven by dysregulated IL‑23 and IL‑17 pathways, and that TYK2 is a key immune-signaling enzyme regulating pathways across innate and adaptive immunity. The company references genomic analyses that, in its view, support a broad therapeutic potential for TYK2 inhibition across multiple immune-driven conditions.
FAQs
The following questions and answers summarize key aspects of Alumis Inc. based on its public disclosures.