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Alumis (NasdaqGS:ALMS) FY Conference Transcript
2025-09-08 21:52
Summary of Alumis FY Conference Call - September 08, 2025 Company Overview - Alumis is a precision immunology company based in the Bay Area, established four years ago, with a focus on TIK2 inhibitors [3][4] - The lead asset, Envuducitinib (ESK-021), is in Phase 3 for psoriasis and Phase 2 for lupus, with readouts expected in early Q1 2026 and Q3 2026, respectively [3][4][16] Pipeline and Strategic Priorities - The company has four key assets, including a second TIK2 inhibitor that is brain-penetrant and shows a 1:1 ratio between blood and brain [3][4] - A preclinical asset, lenaludomab, is expected to enter the clinic soon, with Phase 1 data anticipated next year [4][5] - The company emphasizes genomic analysis and has identified biomarkers related to TIK2, which may help predict responses in lupus and CNS indications [4][5] TIK2 Inhibition and Clinical Insights - TIK2 is considered a promising target due to its genomic richness and specific mutations that may downregulate its kinase function, potentially leading to safer drugs [7][8] - The protective effect of the P1104A mutation against autoimmune diseases is highlighted, with a 50% average protective rate in lupus and psoriasis [8][9] - The company aims to achieve maximum inhibition of TIK2 without significant side effects, which has been a differentiating factor in their clinical trials [10][24] Competitive Landscape - The oral drug market for psoriasis is growing, with oral drugs currently holding a higher patient share than injectables, despite the latter's higher dollar share [14][15] - Alumis aims to develop a high-efficacy oral drug, with Phase 2 data showing promising results that could change treatment paradigms [15][16] - The company is aware of competitors like Sotyktu and Johnson & Johnson's oral IL-23, and believes that their drug's efficacy and safety profile will differentiate it in the market [27][28] Upcoming Trials and Data Expectations - The Phase 3 trial for psoriasis (Onward) is designed with a placebo-controlled portion and an active control section, with data expected in early Q1 2026 [17][18] - The primary endpoint for the trial is PASI 75, with expectations to exceed 50-60% efficacy at week 16 [20][21] - The company is also preparing for a Phase 2 trial for their CNS-penetrant TIK2 inhibitor, which has been delayed to the first half of 2026 due to resource allocation [56][58] Financial Position and Strategic Partnerships - Alumis ended Q2 2025 with $486 million in cash, projecting a runway into 2027, allowing them to navigate key inflection points [53][55] - The company is considering strategic partnerships for global launches, with a focus on maximizing asset value [37][38] Future Opportunities - High conviction in lupus treatment due to successful trials with interferon inhibition, and ongoing analysis to minimize placebo effects in trials [49][50] - Interest in IBD as a potential indication for TIK2, with ongoing research into the genomic data supporting this [52] - Plans to introduce a new molecule targeting a different mechanism, with Phase 1 expected next year [61][62] Conclusion - Alumis is positioned to make significant advancements in the immunology space with its TIK2 inhibitors, focusing on both efficacy and safety, while navigating a competitive landscape and preparing for upcoming clinical data releases. The strategic financial position allows for flexibility in partnerships and future developments.
Alumis Inc.(ALMS) - 2025 FY - Earnings Call Transcript
2025-09-05 14:30
Financial Data and Key Metrics Changes - The company ended the second quarter with $486 million in cash and cash equivalents, providing a runway into 2027 [53] Business Line Data and Key Metrics Changes - The company is focused on Tyk2 inhibitors, with two lead molecules in development: a Phase 3 readout in psoriasis expected in early Q1 next year and a Phase 2b readout in systemic lupus erythematosus (SLE) anticipated in Q3 next year [4][5] Market Data and Key Metrics Changes - The company aims to position its oral Tyk2 inhibitors as a first-line treatment for lupus, targeting patients who currently receive methotrexate or steroids [34] Company Strategy and Development Direction - The company is preparing for commercialization but is considering partnerships for global commercialization due to the potential of the molecule [17] - The strategy includes a robust trial design for lupus, potentially allowing the Phase 2b trial to serve as a pivotal trial, which could streamline the path to registration [27][29] Management's Comments on Operating Environment and Future Outlook - Management believes that the Tyk2 target has significant potential, despite previous disappointments with other molecules in the space, emphasizing the need for maximum target inhibition to achieve efficacy [54][55] - The unmet need in lupus is significant, and the company is optimistic about the potential of its oral therapies to provide safe and effective treatment options [20][26] Other Important Information - The company has a research organization in place to support its pipeline development, including the recently acquired lonigutamab, which is being evaluated for its safety profile [48] - The company is also exploring the potential of its Tyk2 inhibitors in other interferon-driven diseases, which could expand its market opportunities [36] Q&A Session Summary Question: What are the next steps for commercialization? - The company is preparing for commercialization but is unlikely to do so independently on a global scale, considering partnerships based on the data from psoriasis and lupus trials [17] Question: What are the expectations for the lupus trial? - Management believes that achieving a placebo-adjusted benefit of 8% to 15% would position the oral therapy favorably in the market [25] Question: How does the company view the competitive landscape? - The company believes its oral Tyk2 inhibitor has advantages in safety and convenience compared to other therapies, which could make it competitive in the market [16] Question: What is the market opportunity for Tyk2 in lupus? - The company sees the Tyk2 inhibitor as likely being used as a first-line treatment due to its favorable safety profile and ease of administration [34] Question: How does the company plan to address the challenges in lupus trials? - The company has implemented measures to ensure that only patients with active disease are enrolled and has controlled for co-medications to minimize placebo effects [22][24] Question: What is the funding strategy moving forward? - The company aims to maintain sufficient cash reserves to support strategic decisions based on the outcomes of the psoriasis and lupus trials [52]
Alumis (ALMS) 2025 Conference Transcript
2025-09-03 14:47
Alumis (ALMS) 2025 Conference September 03, 2025 09:45 AM ET Company ParticipantsMartin Babler - Chairman, CEO & PresidentJohn Schroer - CFOConference Call ParticipantsEric Schmidt - Biotechnology AnalystNone - AnalystEric SchmidtGood morning, everyone. We're going to kick off our next session. Our pleasure to host our next presenting company, Alumis Inc. My name is Eric Schmidt. I'm joined on stage by Imogen Mansfield, and we're delighted to have with us Alumis Inc.'s CEO, Martin Babler, as well as the com ...
Alumis (ALMS) Earnings Call Presentation
2025-09-03 12:00
Corporate Presentation September 2025 This presentation contains trademarks, service marks, trade names and copyrights of Alumis and other companies which are the property of their respective owners. This presentation discusses product candidates that are under clinical study and which have not yet been approved for marketing by the U.S. Food and Drug Administration. No representation is made as to the safety or effectiveness of these product candidates for the uses for which they are being studied. This pr ...
Alumis to Participate in Upcoming September Investor Conferences
Globenewswire· 2025-08-29 11:00
Core Insights - Alumis Inc. is a late-stage biopharma company focused on developing next-generation targeted therapies for immune-mediated diseases [2] - The company is leveraging a proprietary data analytics platform to create a pipeline of oral tyrosine kinase 2 inhibitors and other therapies [2] - Upcoming investor conferences will feature Alumis, providing opportunities for engagement with investors [1][4] Company Overview - Alumis is developing therapies aimed at improving health outcomes for patients with immune-mediated diseases, including moderate-to-severe plaque psoriasis and systemic lupus erythematosus [2] - The pipeline includes envudeucitinib (formerly ESK-001) and A-005 for various systemic and neuroinflammatory conditions, as well as lonigutamab for thyroid eye disease [2] - The company has several preclinical programs identified through its precision approach [2] Upcoming Events - Alumis will participate in multiple investor conferences in September 2025, including: - Cantor Global Healthcare Conference on September 3 at 9:45 am ET [4] - Wells Fargo 2025 Healthcare Conference on September 5 at 9:30 am ET [4] - Morgan Stanley 23rd Annual Global Healthcare Conference on September 8 at 4:50 pm ET [4] - H.C. Wainwright 27th Annual Global Investment Conference on September 9 at 10:30 am ET [4] - Baird 2025 Global Healthcare Conference on September 10 at 2:35 pm ET [4] - Stifel 2025 Virtual Immunology & Inflammation Forum on September 16 at 12:30 pm ET [4]
Alumis Inc.(ALMS) - 2025 Q2 - Quarterly Report
2025-08-13 20:57
Table of Contents UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-Q (Mark One) ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended June 30, 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) Delaware 86-1771129 (State or other j ...
Alumis Inc.(ALMS) - 2025 Q2 - Quarterly Results
2025-08-13 20:14
Exhibit 99.1 Alumis Reports Second Quarter 2025 Financial Results and Provides Corporate Update -Completed enrollment in Phase 3 ONWARD clinical trials for envudeucitinib in moderate-to-severe plaque psoriasis; topline readout expected in early Q1 2026- -Completed enrollment in Phase 2b LUMUS clinical trial for envudeucitinib in systemic lupus erythematosus (SLE); topline readout expected in Q3 2026- - Completed merger with ACELYRIN, Inc. to strengthen financial position and support advancement of late-stag ...
Alumis Reports Second Quarter 2025 Financial Results and Provides Corporate Update
Globenewswire· 2025-08-13 20:05
Core Insights - Alumis Inc. has completed patient enrollment in pivotal clinical trials for its investigational therapy envudeucitinib, with topline data expected in early Q1 2026 for plaque psoriasis and Q3 2026 for systemic lupus erythematosus [1][2][5] - The company has successfully merged with ACELYRIN, Inc., enhancing its financial position and supporting the advancement of its late-stage immunology pipeline [1][2][7] - As of June 30, 2025, Alumis reported cash, cash equivalents, and marketable securities totaling $486.3 million, which is expected to fund operations into 2027 [1][10] Clinical Development - The Phase 3 ONWARD program for envudeucitinib includes two parallel global trials designed to evaluate its efficacy and safety in adult patients with moderate-to-severe plaque psoriasis, with topline data expected in early Q1 2026 [5][8] - The Phase 2b LUMUS trial for systemic lupus erythematosus has enrolled 408 patients, with topline data anticipated in Q3 2026 [5][8] Financial Performance - For the quarter ended June 30, 2025, Alumis reported total revenue of $2.7 million, primarily from collaboration revenue, compared to no revenue in the same quarter of 2024 [7][15] - Research and development expenses increased to $108.8 million for Q2 2025, up from $48.6 million in Q2 2024, driven by clinical trial costs and merger-related expenses [7][15] - The company recorded a net income of $59.3 million for Q2 2025, including a non-operating gain of $187.9 million from the merger with ACELYRIN, compared to a net loss of $56.5 million in Q2 2024 [7][15] Corporate Developments - The merger with ACELYRIN has strengthened Alumis' balance sheet, allowing for the advancement of its late-stage pipeline through multiple planned key data readouts [6][9] - The company has appointed Sanam Pangali as Chief Legal Officer and Corporate Secretary, bringing nearly two decades of legal expertise [6][8] Pipeline Updates - Alumis is advancing A-005, a fully CNS-penetrant TYK2 inhibitor, towards Phase 2 clinical trials for multiple sclerosis, expected to initiate in the first half of 2026 [8] - The company is also developing lonigutamab, a next-generation therapy for thyroid eye disease, which has received Fast Track Designation from the FDA [8][11]
Alumis Completes Patient Enrollment in the Global LUMUS Phase 2b Trial of ESK-001, a Next-Generation Oral TYK2 Inhibitor for the Treatment of Systemic Lupus Erythematosus
GlobeNewswire News Room· 2025-07-24 11:30
Core Insights - Alumis Inc. has completed patient enrollment in its global LUMUS Phase 2b trial for ESK-001, a next-generation oral TYK2 inhibitor targeting systemic lupus erythematosus (SLE), with topline data expected in Q3 2026 [1][5]. Company Overview - Alumis is a late-stage biopharma company focused on developing targeted therapies for immune-mediated diseases, leveraging a proprietary data analytics platform [7]. - The company is developing a pipeline of oral TYK2 inhibitors, including ESK-001 for SLE and moderate-to-severe plaque psoriasis, and A-005 for neuroinflammatory and neurodegenerative diseases [7]. Clinical Trial Details - The LUMUS Phase 2b trial is a randomized, double-blind, placebo-controlled study involving 408 patients with moderately-to-severely active, autoantibody-positive SLE, assessing the efficacy of ESK-001 over 48 weeks [2][5]. - The primary endpoint of the trial is to evaluate improvements in overall disease activity using the British Isles Lupus Assessment Group-based Composite Lupus Assessment (BICLA) at Week 48 [2][5]. Drug Mechanism and Efficacy - ESK-001 is designed to selectively target key inflammatory drivers, such as type 1 interferon (IFN), aiming for maximal inhibition while minimizing off-target effects [3][4]. - Clinical data from the psoriasis program indicates that ESK-001 downregulates key cytokines and disease biomarkers, suggesting potential to reduce SLE disease activity [4]. Future Prospects - The company anticipates that ESK-001 could provide biologic-like clinical responses for SLE, based on its performance in previous clinical studies [4].
Alumis Completes Patient Enrollment in the Global LUMUS Phase 2b Trial of ESK-001, a Next-Generation Oral TYK2 Inhibitor for the Treatment of Systemic Lupus Erythematosus
Globenewswire· 2025-07-24 11:30
Core Insights - Alumis Inc. has completed patient enrollment in its global LUMUS Phase 2b trial for ESK-001, a next-generation oral TYK2 inhibitor aimed at treating systemic lupus erythematosus (SLE) [2][3] - The trial enrolled 408 patients and topline data is expected in Q3 2026, marking a significant milestone for both the company and the lupus community [3][6] - ESK-001 is designed to selectively target key inflammatory drivers, potentially offering a new treatment option for patients with SLE who currently have limited choices [3][4] Company Overview - Alumis is a late-stage biopharma company focused on developing targeted therapies for immune-mediated diseases, leveraging a proprietary data analytics platform [8] - The company's pipeline includes ESK-001 for SLE and moderate-to-severe plaque psoriasis, as well as A-005 for neuroinflammatory and neurodegenerative diseases [8] - Alumis aims to improve patient health outcomes through its innovative therapies and precision approach [8] Clinical Trial Details - The LUMUS Phase 2b trial is a randomized, double-blind, placebo-controlled study evaluating multiple doses of ESK-001 over 48 weeks [6] - The primary endpoint is to assess improvements in overall disease activity using the British Isles Lupus Assessment Group-based Composite Lupus Assessment (BICLA) at Week 48 [3][6] - Following the trial, eligible patients may participate in an open-label extension or a four-week safety follow-up [3] ESK-001 Mechanism and Previous Data - ESK-001 is a highly selective TYK2 inhibitor that targets proinflammatory mediators, aiming for maximal inhibition with minimal off-target effects [4][5] - Clinical data from Alumis' psoriasis program indicates that ESK-001 effectively downregulates key cytokines and disease biomarkers, suggesting potential efficacy in reducing SLE disease activity [5] - Phase 1 studies showed that ESK-001 achieved full, sustained target inhibition and was well tolerated in healthy volunteers [5]