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Alumis Inc.(ALMS) - 2025 Q4 - Annual Report
2026-03-19 20:23
Table of Contents UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, D.C. 20549 FORM 10-K ☒ ANNUAL REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the fiscal year ended December 31, 2025 OR ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from to Commission file number: 001-42143 Alumis Inc. (Exact name of registrant as specified in its charter) (State of other jurisdiction of incorporation or org ...
Alumis Reports Year End 2025 Financial Results and Highlights Recent Achievements
Globenewswire· 2026-03-19 20:05
Core Insights - Alumis Inc. reported positive Phase 3 topline results for envudeucitinib, showing significant skin clearance and symptom improvement in moderate-to-severe plaque psoriasis, along with a favorable safety profile [1][2] - The company plans to submit a New Drug Application (NDA) for envudeucitinib in the second half of 2026 [1] - Anticipated pivotal Phase 2b clinical data for envudeucitinib in systemic lupus erythematosus (SLE) is expected in the third quarter of 2026 [1][7] - Alumis completed a public offering, raising approximately $345.1 million in gross proceeds in January 2026 [1][5] Phase 3 Clinical Trials - The Phase 3 ONWARD1 and ONWARD2 trials for envudeucitinib met all primary and secondary endpoints with high statistical significance [5] - Approximately 65% of patients achieved a Psoriasis Area Severity Index (PASI) 90, and over 40% achieved PASI 100 at Week 24 [5] - The drug demonstrated a favorable safety and tolerability profile consistent with earlier Phase 2 results [5] Financial Performance - For the year ended December 31, 2025, Alumis reported total revenue of $24.05 million, primarily from license and collaboration revenue [15] - Research and development expenses increased to $386.0 million from $265.6 million in 2024, driven by clinical trial costs and increased headcount [12][15] - The net loss for 2025 was $243.3 million, an improvement from a net loss of $294.2 million in 2024 [12][15] Pipeline and Future Plans - Alumis is evaluating additional indications for envudeucitinib beyond psoriasis and SLE, as part of a unified TYK2 franchise development strategy [2][5] - An update on the TYK2 franchise strategy, including the timing for commencing A-005's Phase 2 trial, is expected in the second quarter of 2026 [5][8] - The company plans to present additional Phase 3 data at the American Academy of Dermatology (AAD) Annual Meeting in March 2026 [11]
Alumis Announces Late-Breaker Oral Presentation of Phase 3 Data for Envudeucitinib in Moderate-to-Severe Plaque Psoriasis at 2026 American Academy of Dermatology Annual Meeting
Globenewswire· 2026-03-18 12:00
– Phase 3 data presentation highlighting results from the ONWARD1 and ONWARD2 clinical trials of envudeucitinib – – Phase 2 STRIDE e-poster presentation to describe disease biomarker activity of envudeucitinib – – Alumis to host investor webcast on Sunday, March 29, 2026, at 5:00 pm MDT / 7:00 pm EDT – SOUTH SAN FRANCISCO, Calif., March 18, 2026 (GLOBE NEWSWIRE) -- Alumis Inc. (Nasdaq: ALMS), a late-stage biopharmaceutical company developing next-generation targeted therapies for patients with immune-mediat ...
Alumis to Present at the Leerink Partners Global Healthcare Conference
Globenewswire· 2026-03-02 13:05
Core Insights - Alumis Inc. is a late-stage biopharma company focused on developing next-generation targeted therapies for immune-mediated diseases [3] Company Overview - Alumis is developing a pipeline of oral tyrosine kinase 2 inhibitors, including envudeucitinib for systemic immune-mediated disorders and A-005 for neuroinflammatory diseases [3] - The company also has lonigutamab, an anti–insulin-like growth factor 1 receptor therapy for thyroid eye disease, along with several preclinical programs [3] Upcoming Events - Martin Babler, President and CEO of Alumis, will participate in a fireside chat at the Leerink Partners Global Healthcare Conference on March 9, 2026, at 10:40 a.m. ET [1] - A live webcast of the event will be available on the Alumis website, with a replay archived for 90 days [2]
Alumis (NasdaqGS:ALMS) FY Conference Transcript
2026-02-26 21:22
Summary of Alumis Conference Call Company Overview - **Company**: Alumis - **Event**: Oppenheimer's Annual Healthcare Conference - **Key Speakers**: Martin Babler (CEO), John Schroer (CFO) Core Industry and Product Insights Psoriasis Treatment - **Product**: Envudeucitinib - **Phase 3 Data**: Positive top-line results announced in January - **Primary Endpoint Results**: - PASI 75: Average of 74% - sPGA 0/1: Average of 59% at week 16 [3][4] - **Secondary Results**: - PASI 90: Approximately 65% at week 24 - PASI 100: Just over 40% on average [5] - **Safety Profile**: Consistent with Phase II results; common side effects include headaches, upper respiratory infections, and acne. No malignancy signals observed [6][15][19]. Competitive Landscape - **Competitors**: J&J's IL-23 blocker and Takeda's TYK2 inhibitors - **Market Positioning**: Emphasis on the unique benefits of the TYK2 pathway, including improved patient-reported outcomes and quality of life [7][9]. - **Dosing Preference**: Market research indicates a preference for a twice-daily dosing regimen without food effects over a once-daily regimen with fasting requirements [11][12]. Regulatory and Commercial Plans - **NDA Submission**: Planned for the second half of the year, contingent on 48-week data [25]. - **Commercial Strategy**: Strong plan in place, with considerations for potential partnerships due to the broad indication landscape [26]. Future Opportunities Systemic Lupus Erythematosus (SLE) - **Unmet Need**: High demand for effective oral treatments; current approved drugs have low efficacy [27]. - **Ongoing Trial**: Phase 2b trial with over 400 patients, primary endpoint BICLA, results expected in Q3 [28]. - **Execution Strategy**: Focus on patient selection and managing co-medications to minimize placebo rates [30]. Pipeline Developments - **Lonigutamab**: Ongoing evaluation of its mechanism and competitive landscape; potential for CNS indications [39][41]. - **CNS Penetrant TYK2**: Consideration of broader applications beyond CNS [39]. Additional Considerations - **Malignancy Concerns**: No significant malignancy signals observed; background rates of cancer in trials acknowledged [18][21]. - **FDA Guidance**: Recent communications suggest potential for single trial approvals, which could impact SLE trial strategy [35][36]. This summary encapsulates the key points discussed during the conference call, highlighting Alumis's strategic positioning, product developments, and future opportunities in the healthcare market.
Alumis (NasdaqGS:ALMS) 2026 Conference Transcript
2026-02-12 15:02
Summary of Alumis Conference Call Company Overview - **Company**: Alumis - **Industry**: Precision Immunology, specifically focusing on psoriasis and other autoimmune diseases Key Points and Arguments Financial and Operational Highlights - Alumis has a strong balance sheet with over **$630 million** in cash, providing runway into the **fourth quarter of 2027** [91] - The company is preparing for a potential NDA filing in the **second half of 2023** [37] Clinical Development - **Envudeucitinib**: Phase 3 results in psoriasis show: - **PASI 75** at week 24 is in the **70s%** - **PASI 90** and **PASI 100** rates are approximately **65%** and **40%**, respectively [3] - Fast onset of action with separation of PASI scores observed as early as week 4 [3] - Safety profile consistent with Phase II data, with no new safety signals [3] Market Dynamics - The oral drug market for psoriasis is expected to expand significantly, as **75%** of psoriasis patients prefer oral medications over injectables or topicals [27] - Current market dynamics indicate that the patient share of oral drugs is higher than that of injectables [25] - Alumis aims to position itself strongly in the oral psoriasis market, particularly for patients with scalp involvement and significant itch [31] Competitive Landscape - The company acknowledges competition from other TYK2 inhibitors, including **Sotyktu** and **Zasocitinib** from Takeda [22] - Alumis believes its product has a competitive edge in terms of efficacy and quality of life improvements [18] Future Indications and Research - Alumis is exploring additional indications beyond psoriasis, including **Systemic Lupus Erythematosus (SLE)** and other autoimmune diseases [46] - The company is conducting a pivotal Phase IIb trial for SLE, with results expected in the **third quarter of 2023** [52] - The potential for **20+ indications** is being considered, with a focus on optimizing the psoriasis indication and exploring rheumatology-related conditions [70] Strategic Partnerships - While Alumis has the capability to launch its products independently, the company is open to partnerships to optimize its TYK2 franchise across multiple indications [41][43] Conclusion - Alumis is positioned for significant growth in the precision immunology space, with promising clinical data and a strong financial foundation. The company is strategically preparing for market entry while exploring a broad pipeline of indications.
Alumis to Participate in Upcoming February Investor Conferences
Globenewswire· 2026-02-05 13:05
Company Overview - Alumis Inc. is a late-stage biopharma company focused on developing next-generation targeted therapies for immune-mediated diseases [2] - The company utilizes a proprietary data analytics platform and precision approach to enhance patient health and outcomes [2] Product Pipeline - Alumis is developing a pipeline of oral tyrosine kinase 2 inhibitors, including envudeucitinib (formerly ESK-001), aimed at treating systemic immune-mediated disorders such as moderate-to-severe plaque psoriasis and systemic lupus erythematosus [2] - The pipeline also features A-005 for neuroinflammatory and neurodegenerative diseases, and lonigutamab, a subcutaneously delivered therapy for thyroid eye disease [2] - Several preclinical programs have been identified through the company's precision approach [2] Investor Engagement - Alumis will participate in multiple investor conferences, including the Guggenheim Emerging Outlook: Biotech Summit 2026 on February 11-12, 2026, and the Oppenheimer 36th Annual Healthcare Life Sciences Conference on February 25-26, 2026 [4] - Live webcasts of these events will be accessible on the company's website, with replays archived for 90 days [1][4]
Alumis Stock Has Rallied 250% This Past Year. One Fund Sold Its $5 Million Stake Last Quarter.
Yahoo Finance· 2026-02-03 15:06
Core Insights - BML Capital Management has completely liquidated its stake in Alumis, selling 1,210,415 shares for approximately $4.83 million, resulting in a total position value decrease in Alumis [1][2] Company Overview - Alumis is a clinical-stage biotechnology company focused on developing therapies for autoimmune and neuroinflammatory diseases, leveraging TYK2 inhibition to create differentiated drug candidates [6][9] - The company has a market capitalization of $3.3 billion, with a revenue of $22.12 million and a net income of -$245.15 million for the trailing twelve months [4] Stock Performance - As of February 2, shares of Alumis were priced at $26.42, reflecting a 255.1% increase over the previous year, significantly outperforming the S&P 500's approximate 15% gain during the same period [3] Financial Context - The decision to sell was made before Alumis announced a public offering in January, which subsequently led to a surge in share price by roughly 200% [10] - The company reported $377.7 million in cash and marketable securities as of the third quarter, indicating a need for substantial funding to advance its TYK2 inhibitor programs [11] Market Dynamics - The market's reaction to the January offering shifted the narrative from capital risk to clinical optionality, leading to a rapid repricing of the stock [12] - The exit from Alumis by BML Capital was more about exposure control rather than a negative assessment of the company's scientific prospects [12]
Chardan Highlights Alumis’s (ALMS) Potential After Envudeucitinib Hits All Phase 3 Endpoints in Psoriasis Trials
Yahoo Finance· 2026-01-30 14:48
Group 1 - Alumis Inc. (NASDAQ:ALMS) has been recognized as a rising stock, with Chardan initiating coverage with a Buy rating and a price target of $37, driven by the potential of its late-stage autoimmune pipeline, particularly the drug envudeucitinib [1] - Envudeucitinib, a TYK2 inhibitor, has successfully met all primary and secondary endpoints in two Phase III trials for moderate-to-severe plaque psoriasis, demonstrating high statistical significance in skin clearance and patient-reported outcomes [1] - H.C. Wainwright has increased its price target for Alumis to $40 from $20, citing reduced regulatory failure risk and a higher projected revenue ceiling following the successful Phase 3 data [2] Group 2 - Morgan Stanley raised its price target for Alumis to $33 from $22, reflecting increased optimism about the drug's performance in treating moderate-to-severe plaque psoriasis, with the probability of success for this indication now at 80% [3] - Alumis is a clinical-stage biopharmaceutical company focused on developing and commercializing medicines for autoimmune disorders, previously known as Esker Therapeutics [4]
An Almus (ALMS) Insider Bought 588,000 Shares for $10.0 Million
Yahoo Finance· 2026-01-17 19:06
Core Insights - The transaction indicates a significant insider purchase by Srinivas Akkaraju, Director of Alumis, acquiring 588,235 shares for approximately $10.0 million, reflecting a strong belief in the company's future performance [5][6]. Company Overview - Alumis is a clinical-stage biotechnology company focused on developing therapies for autoimmune and neuroinflammatory diseases, leveraging advanced TYK2 inhibitor technology to address unmet medical needs [7]. Transaction Details - The shares were purchased at $17.00 each, which is below recent market prices, suggesting a favorable entry point for the insider [2][6]. - This acquisition is one of the largest recorded for Akkaraju, increasing his cumulative indirect holdings by nearly 47% in a single transaction [4][5]. Market Performance - Alumis' stock has appreciated significantly, with a 206.29% increase over the past year and over 400% in the last three months, indicating strong market confidence [5][8]. - The company recently reported successful phase 3 trial results for envudeucitinib, showing that 65% of patients achieved a 90% or better improvement in psoriasis severity scores [9]. Competitive Landscape - Alumis' psoriasis treatment candidate appears to be more effective than Amgen's Otezla, which had 33% of patients achieving a 75% improvement in similar trials [10].