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Alumis Inc. reports clinical, financing and corporate updates as a late-stage biopharmaceutical company developing next-generation targeted therapies for immune-mediated diseases. Its pipeline centers on oral TYK2 inhibitors, including envudeucitinib for systemic immune-mediated disorders such as moderate-to-severe plaque psoriasis and systemic lupus erythematosus, and A-005 for neuroinflammatory and neurodegenerative diseases. The company also lists lonigutamab, a subcutaneously delivered anti–insulin-like growth factor 1 receptor therapy for thyroid eye disease, and preclinical programs identified through its precision approach.
Recurring ALMS news includes envudeucitinib clinical data from the ONWARD and STRIDE programs, disease-biomarker presentations, financial results, investor conference communications and common-stock financing activity.
Alumis (Nasdaq: ALMS) announced new Phase 1 data presentations for A-005, their first-in-class CNS penetrant TYK2 inhibitor, at the ACTRIMS Forum 2025. A-005 demonstrated potent inhibition of TYK2-specific signaling in immune cells and CNS resident cells, with the ability to cross the blood-brain barrier.
The Phase 1 clinical trials showed that A-005 was well-tolerated and achieved maximal TYK2 inhibition across various doses. The company plans to advance to Phase 2 clinical trials for multiple sclerosis patients in the second half of 2025.
Two presentations are scheduled for February 28, 2025: one focusing on A-005's effects on astrocytes and microglia (Poster P352), and another discussing safety, tolerability, and pharmacokinetics in healthy volunteers (Poster P335).
Alumis (Nasdaq: ALMS), a clinical-stage biopharmaceutical company focused on developing oral therapies for immune-mediated diseases, has announced its participation in the Oppenheimer 35th Annual Healthcare Life Sciences Conference. Martin Babler, the company's President and CEO, will deliver a presentation at the virtual event on Tuesday, February 11, 2025, at 3:20 pm ET. Interested parties can access a live webcast of the presentation through the 'Events' page in the 'Investors' section of the Alumis website.
Alumis (ALMS) and ACELYRIN (SLRN) announced a merger agreement creating a late-stage clinical biopharma company focused on immune-mediated diseases. The all-stock transaction will result in Alumis stockholders owning ~55% and ACELYRIN stockholders ~45% of the combined company.
The merged entity will operate under the Alumis name with a pro forma cash position of approximately $737 million as of December 31, 2024, providing runway into 2027. The combined pipeline includes Alumis' ESK-001, currently in Phase 3 trials for psoriasis with topline data expected in H1 2026, and ACELYRIN's lonigutamab for thyroid eye disease.
The transaction is expected to close in Q2 2025, subject to stockholder approval. Stockholders representing ~62% of Alumis and ~24% of ACELYRIN have already agreed to support the merger.
Alumis (Nasdaq: ALMS) has strengthened its leadership team with key appointments to support its transition to a late-stage company. Jack Danilkowicz has been appointed as Chief Commercial Officer, bringing extensive experience in commercial strategies from Amgen and Horizon Therapeutics, where he helped grow annual net product sales from $300 million to nearly $4 billion.
Sara Klein has been promoted to Chief Legal Officer, continuing to direct corporate legal and compliance matters. Roy Hardiman, the previous legal officer, will now serve as Chief Business and Strategy Officer. These appointments come as Alumis advances its next-generation TYK2 inhibitor ESK-001 through Phase 3 ONWARD clinical program in plaque psoriasis and a potential pivotal Phase 2b trial in systemic lupus erythematosus.
Alumis (NASDAQ: ALMS) announced positive Phase 1 clinical trial results for A-005, their CNS penetrant TYK2 inhibitor. The trial demonstrated that A-005 successfully crosses the blood-brain barrier and achieves maximal TYK2 inhibition with favorable pharmacokinetics in both CNS and peripheral systems.
Key findings include: no serious adverse events reported, significant and prolonged exposure in cerebral spinal fluid, dose-proportional drug exposure, peak drug concentration with half-lives up to 12 hours, and established PK/PD relationship showing sustained TYK2 inhibition. The company plans to advance to Phase 2 clinical trials for multiple sclerosis in the second half of 2025.
Alumis (Nasdaq: ALMS) announced two data presentations at ACR Convergence 2024 highlighting their oral treatment ESK-001 for Systemic Lupus Erythematosus (SLE). The presentations demonstrate that ESK-001, a selective allosteric oral tyrosine kinase 2 (TYK2) inhibitor, effectively suppresses both a novel disease biomarker and Type 1 interferons, which are key drivers of SLE. The company's proprietary data analytics platform identified novel pathways in SLE that can be suppressed through TYK2 inhibition. The Phase 2b LUMUS study in SLE is ongoing, with top-line data expected in 2026.
Alumis (NASDAQ: ALMS) reported Q3 2024 financial results and recent achievements. The company presented promising data at EADV for ESK-001 in psoriasis treatment, with 93% of patients achieving PASI 75 at the 40mg twice daily dose. Currently advancing three clinical programs: Phase 3 ONWARD trials for psoriasis, Phase 2b for systemic lupus erythematosus, and Phase 1 for A-005 in neuroinflammatory diseases. Q3 financial results showed cash position of $361.9 million, expected to fund operations into 2026. Net loss increased to $93.1 million compared to $43.4 million in Q3 2023, with R&D expenses at $87.8 million and G&A expenses at $10.6 million.
Alumis (Nasdaq: ALMS) has announced its participation in Guggenheim's Inaugural Healthcare Innovation Conference. President and CEO Martin Babler will engage in a fireside chat on Tuesday, November 12, 2024, at 2:00 pm ET in Boston, MA. The clinical-stage biopharmaceutical company, which focuses on developing oral therapies for immune-mediated diseases using precision approaches, will provide a live webcast of the event on their website's Investors section. The webcast recording will remain accessible for 90 days after the event.
Alumis Inc. (Nasdaq: ALMS) announced positive 28-week data from the open-label extension (OLE) of its Phase 2 STRIDE trial for ESK-001, an oral TYK2 inhibitor for moderate-to-severe plaque psoriasis. The data, presented at the 2024 EADV Congress, showed:
- Dose-dependent sustained increases in PASI responses over time
- 93% of patients on 40 mg twice daily achieved PASI 75
- Favorable safety profile with mostly mild-to-moderate TEAEs
- Biomarker data supporting the 40 mg twice daily dose for Phase 3
The company expects to report full 52-week OLE data in 1H 2025 and is advancing ESK-001 in the Phase 3 ONWARD program. Additional presentations at EADV supported ESK-001's potential as a best-in-class treatment, showing improvements in quality of life and pruritus.
Alumis Inc. (Nasdaq: ALMS), a clinical-stage biopharmaceutical company, has announced its participation in several investor conferences in September 2024. The company, which focuses on developing oral therapies for immune-mediated diseases, will be present at five major healthcare and investment events:
1. Morgan Stanley Global Healthcare Conference (Sept. 5)
2. Wells Fargo Healthcare Conference (Sept. 6)
3. Baird Global Healthcare Conference (Sept. 11)
4. Cantor Fitzgerald Global Healthcare Conference (Sept. 17)
5. Stifel Immunology and Inflammation Virtual Summit (Sept. 18)
Alumis management will engage in various formats including fireside chats, presentations, and one-on-one investor meetings. Webcasts will be available for some events on the company's website.