Alumis (NasdaqGS:ALMS) Update / Briefing January 06, 2026 08:00 AM ET Company ParticipantsJohn Schroer - CFODerek Archila - Managing Director and Co-Head of Therapeutics ResearchMartin Babler - CEOJörn Drappa - CMOConference Call ParticipantsBrian Skorney - Senior Research AnalystYatin Suneja - Senior Managing Director and Biotechnology AnalystThomas Smith - Senior Research AnalystMitchell Kapoor - Director and Senior Biotechnology AnalystJeff Jones - Managing Director and Senior AnalystTerence Flynn - Equi ...

Envudeucitinib ONWARD1 and ONWARD2 Phase 3 Topline Readout Analyst and Investor Webcast – January 6, 2026 1 Forward-Looking Statements This presentation contains forward looking statements within the meaning of federal securities laws, including the "safe harbor" provisions of the Private Securities Litigation Reform Act of 1995. Such statements are based upon current plans, estimates and expectations of management of Alumis Inc. ("Alumis") in light of historical results and trends, current conditions and p ...

Core Insights - Alumis Inc. is advancing its pipeline with key milestones expected in early 2026, including topline Phase 3 ONWARD data for envudeucitinib in moderate-to-severe plaque psoriasis and Phase 2b LUMUS data in systemic lupus erythematosus [2][4] Financial Results - For the quarter ended September 30, 2025, Alumis reported total revenue of $2.1 million, primarily from collaboration revenue, compared to no revenue in the same quarter of 2024 [10][12] - Research and development expenses increased to $97.8 million from $87.8 million year-over-year, driven by higher clinical trial costs and severance expenses related to the merger with ACELYRIN [10][12] - General and administrative expenses rose to $19.5 million from $10.6 million year-over-year, attributed to severance costs and increased personnel-related expenses [10][12] - The net loss for the quarter was $110.8 million, compared to a net loss of $93.1 million in the same quarter of 2024 [10][12] Cash Position - As of September 30, 2025, Alumis had cash, cash equivalents, and marketable securities totaling $377.7 million, which is expected to support its pipeline advancement through 2027 [7][10] Pipeline Developments - Envudeucitinib is a next-generation oral TYK2 inhibitor showing promise in treating immune-mediated diseases, with positive results from Phase 2 trials published in the Journal of the American Academy of Dermatology [5][8] - A-005, another TYK2 inhibitor, is set to enter a Phase 2 clinical trial for multiple sclerosis in the first half of 2026 [5][4] - Lonigutamab, an anti-IGF-1R therapy for thyroid eye disease, is also progressing with positive early results [5][4]

Summary of Alumis Conference Call Company Overview - **Company**: Alumis (NasdaqGS:ALMS) - **Focus**: Development of TYK2 inhibitors for autoimmune diseases, specifically psoriasis and lupus [2][4] Key Points Product Pipeline - **Envudeucitinib**: - Phase 3 trial for psoriasis nearing completion, with data readout expected in Q1 2026 [4] - Phase 2b trial for systemic lupus erythematosus (SLE) planned for Q3 2026 [4] - **Second TYK2 Inhibitor**: - A brain-penetrant TYK2 inhibitor entering Phase 2 for multiple sclerosis (MS) in H1 2026 [3] - **Lonigutamab**: - Acquired through merger with Acelyrin, currently in Phase 2 [3] Market Opportunity - **Psoriasis**: - Significant unmet need for high-efficacy oral drugs; over 75% of patients prefer oral medications over injectables [5][6] - Current leading drugs are Otesla and methotrexate, indicating a gap for better-tolerated options [6] - **Lupus**: - No approved oral therapies currently available; potential for Envudeucitinib to fill this gap [14] - Anifrolumab, a competitor, is projected to reach $1 billion in sales, highlighting market potential [14] Clinical Data and Efficacy - **Psoriasis Data**: - Phase 2 results show PASI 75 efficacy between 80-90%, PASI 90 between 60-70%, and PASI 100 between 35-45% [11] - Strong impact on itch reduction, with over 70% of patients experiencing significant improvement [12] - **Safety Profile**: - Data from over 2,000 patients shows no significant safety signals, critical for market acceptance [7] Competitive Landscape - **TYK2 Inhibitors**: - Conviction that TYK2 can be effective across various immune indications based on early data [4][20] - Comparison with other TYK2 inhibitors indicates a more favorable PK/PD profile for Envudeucitinib [21][23] - **Market Positioning**: - Emphasis on the simplicity of oral administration as a competitive advantage [9][30] Strategic Considerations - **Partnership Strategy**: - Plans to partner Envudeucitinib to maximize asset value, with flexibility to wait for additional data before finalizing partnerships [32][33] - **Cash Position**: - Over $480 million in cash, providing runway into 2027 to support ongoing trials [37] Future Outlook - **2026 Expectations**: - Anticipation of multiple transformational events, including data readouts for psoriasis and lupus [4][18] - **Long-term Vision**: - Continued development of A-005 and Lonigutamab as part of Alumis's future pipeline [34] Additional Insights - **Genomic Data**: - Strong correlation between TYK2 inhibition and autoimmune disease prevention, suggesting a robust scientific foundation for the drug's efficacy [10][20] - **Enrollment Success**: - Rapid enrollment in lupus trials, indicating strong investigator interest and confidence in the drug's profile [30][31]

Summary of Alumis Conference Call Company Overview - **Company**: Alumis - **Lead Asset**: Envutuzitinib, a TYK2 inhibitor - **Age**: Approximately 4.5 years old, approaching 5 years Key Points and Arguments Product Development and Pipeline - **Envutuzitinib** is the lead molecule targeting autoimmune diseases, particularly psoriasis and lupus [2][3] - The company has three clinical assets, all beyond phase one, with the lead indication being psoriasis [3] - **Psoriasis Program**: Expected data readout in early Q1 next year, with confidence in competitive positioning based on preclinical and phase two data [3][4] - **Lupus Program**: Phase 2b trial designed as a pivotal trial, with data expected in Q3 next year [4] Competitive Landscape - Anticipation of multiple readouts in the TYK2 space from competitors next year [6] - The company plans to partner Envutuzitinib, which could influence overall business strategy [6] Clinical Trial Insights - **Phase Two Data**: Envutuzitinib showed a clear dose response, with the ability to dose-increase without reduction, distinguishing it from competitors [9][10] - **Enrollment Success**: Rapid enrollment attributed to the simplicity and safety of the drug, leading to over-enrollment in trials [12][13] - **Demographics**: Phase two primarily involved U.S. and Canadian patients, with expectations for more diverse demographics in phase three [15][16] Market Expectations - Aiming for PASI 90 response rates between 60-70% in phase three, which would position the product competitively [23][24] - Potential NDA filing could occur next year, pending data collection on durability and maintenance [25] Lupus Opportunity - The LUMA study involves over 400 patients, with data expected in Q3 next year [29] - The primary endpoint is BICLA, with secondary endpoints including SRI-4 [31] Future Indications - If lupus trial is successful, it may open opportunities in other interferon-driven diseases [35] - Interest in exploring indications for inflammatory bowel disease (IBD) based on competitor trials [35] Other Assets - **A-005**: A brain-penetrant molecule, with phase one completed and plans to start phase two in MS in the first half of next year [36][37] - **Lonigutamab**: Under evaluation for potential development, with ongoing assessments of competitive landscape [40] Financial Health - The company reported a strong balance sheet with over $480 million at the end of Q2, providing a cash runway into 2027 [41]

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]

Financial Status and Pipeline - Alumis had $486.3 million in cash, cash equivalents, and marketable securities as of June 30, 2025, expected to fund operations into 2027[12] - The company has a portfolio of three clinical molecules against validated targets, including Envudeucitinib, A-005, and Lonigutamab, plus multiple pipeline assets in late-stage research[12] Envudeucitinib (TYK2 Inhibitor) - Phase 3 topline data for Envudeucitinib in Psoriasis is expected in early Q1 2026, and Phase 2b topline data for SLE is expected in Q3 2026[12] - Envudeucitinib targets a market opportunity greater than $4 billion in SLE[27, 75] - In a Phase 2 trial, Envudeucitinib demonstrated high statistical significance at Week 12 (PASI 75: p < 0001)[45] - Approximately 75% of psoriasis patients prefer an oral therapy[25, 33, 40] A-005 (CNS Penetrant TYK2 Inhibitor) - A-005 is a first-in-class brain-penetrant TYK2 inhibitor for neuroinflammation and neurodegeneration, with Phase 2 initiation in MS expected in 1H 2026[14, 16] - A-005 demonstrated full CNS penetration in Phase 1, with doses established to provide high peripheral and CSF exposure[29, 86] Lonigutamab (Anti-IGF-1R Therapy) - Lonigutamab is an anti-IGF-1R therapy with a unique MOA for Thyroid Eye Disease (TED), with development program evaluation ongoing[12, 16] Market Opportunities - Near-term results could unlock interferon and IL-23 pathway-driven diseases with global market opportunities greater than $150 billion[15] - Approximately 16 million people worldwide have moderate-to-severe psoriasis, representing a global market of over $25 billion[40] Kaken Collaboration - Alumis is receiving $40 million near-term for Japan, which is less than 5% of the worldwide psoriasis market (estimated at $600 million in 2024), highlighting significant opportunity for Alumis in ROW[72]

Pipeline and Milestones - Alumis expects topline data from Phase 3 ONWARD trials for envudeucitinib in moderate-to-severe plaque psoriasis in early 1Q 2026[11] - Alumis anticipates topline data from Phase 2b LUMUS trial in systemic lupus erythematosus in 3Q 2026[11] - Alumis plans to initiate a Phase 2 clinical trial for A-005 in multiple sclerosis in 1H 2026[11] - Alumis is evaluating the development program for lonigutamab in thyroid eye disease[12] - Alumis expects Phase 1 data for its next program in 2026[12] Financial Position - Alumis had $486.3 million in cash as of June 30, 2025, providing runway into 2027[11] Envudeucitinib (TYK2 Inhibitor) - Envudeucitinib demonstrated a 15-20% increase in clinical response (PASI) with maximal target inhibition[23] - In the STRIDE trial, Envudeucitinib 40 mg BID showed a 64.1% PASI-75 response at Week 12[39] - Approximately 92% of diagnosed psoriasis patients are not treated with a biologic therapy, representing a market opportunity for Envudeucitinib[35] - Alumis is receiving $40 million near-term for Japan, <5% of Worldwide Psoriasis Market (estimated at $600M in 2024)[69] A-005 (CNS-Penetrant TYK2 Inhibitor) - A-005 achieves a CSF:Plasma (free drug) ratio of approximately 1:1, indicating full CNS penetration[75]