Company Overview - Alumis Inc. is a clinical-stage biopharmaceutical company focused on developing next-generation targeted therapies for immune-mediated diseases [5] - The company is leveraging a proprietary data analytics platform and precision approach to develop its pipeline of therapies [5] Public Offering Announcement - Alumis announced plans to commence an underwritten public offering of $175.0 million of its common stock, with an additional option for underwriters to purchase up to $26.25 million of shares [1] - The offering is subject to market conditions and there is no assurance regarding its completion or terms [1] Management of the Offering - Morgan Stanley, Leerink Partners, Cantor, and Wells Fargo Securities are acting as joint book-running managers for the proposed offering [2] Regulatory Compliance - The offering is being made pursuant to a shelf registration statement on Form S-3, which was previously filed and declared effective by the SEC on August 19, 2025 [3] - A preliminary prospectus supplement and accompanying prospectus will be filed with the SEC and will be available for free on the SEC's website [3]

Core Insights - Alumis Inc (NASDAQ:ALMS) shares surged by 107.9% to $17.28 after the company announced that its plaque psoriasis drug, envudeucitinib, successfully met all primary and secondary endpoints in both phase three trials [1] Group 1: Stock Performance - ALMS has reached record highs today, aiming to end a seven-day losing streak and potentially achieving its best day on record, with a year-over-year increase of approximately 100% [2] - The stock's options market is experiencing significant activity, with 3,492 calls and 5,948 puts traded, which is 39 times the average daily options volume [3] Group 2: Market Dynamics - The stock has been placed on the short sell restricted (SSR) list due to its volatility, with short interest accounting for 6.2% of the available float, equating to four days of potential buying power [4]

Core Insights - Alumis Inc. (NASDAQ:ALMS) stock is experiencing a significant increase, trading at a new 52-week high of $17.91, up 115.58% [8] - The company released positive topline results from its Phase 3 ONWARD1 and ONWARD2 clinical trials for envudeucitinib, a treatment for moderate-to-severe plaque psoriasis [1][3] Clinical Trial Results - Envudeucitinib met all primary and secondary endpoints with high statistical significance in both ONWARD1 and ONWARD2 trials [3] - On average, 74% of patients achieved a Psoriasis Area and Severity Index (PASI) 75 response, and 59% achieved a static Physician's Global Assessment (sPGA) 0/1 at Week 16 [4] - At Week 24, approximately 65% of patients achieved PASI 90, and over 40% achieved PASI 100 across both trials [4] - Rapid responses were noted, with significant separation from placebo on PASI 90 as early as Week 4 [5] Comparative Efficacy - Envudeucitinib demonstrated superior skin clearance compared to Amgen Inc.'s Otezla (apremilast) on all PASI endpoints at Week 24 [5] - Consistent and clinically meaningful improvements were observed in patient-reported outcomes related to itch and quality of life [5] Safety Profile - Treatment with envudeucitinib was generally well tolerated through Week 24, with a safety profile consistent with Alumis' Phase 2 program [6] Future Developments - Alumis plans to present additional results from ONWARD1 and ONWARD2 at an upcoming medical meeting and intends to submit a New Drug Application (NDA) to the U.S. Food and Drug Administration in the second half of 2026 [7] - Topline data from the LUMUS Phase 2b trial of envudeucitinib in systemic lupus erythematosus (SLE) is expected in the third quarter of 2026 [7]

Summary of Alumis Conference Call Company Overview - **Company**: Alumis - **Lead Candidate**: Nvudusitinib, a next-generation TYK2 inhibitor - **Focus**: Treatment of moderate to severe plaque psoriasis and potential applications in other immune-mediated diseases Key Points from the Call Clinical Results - **Phase 3 Results**: Positive outcomes for Nvudusitinib, exceeding Phase 2 results with statistically significant efficacy on primary and secondary endpoints [4][5] - **Efficacy Metrics**: - 74% of patients achieved PASI 75 and 59% achieved sPGA 0/1 at week 16 [12] - Approximately 65% achieved PASI 90 and over 40% achieved PASI 100 at week 24 [12] - **Safety Profile**: Favorable safety and tolerability consistent with Phase 2 data, with most adverse events being mild to moderate [13] Market Opportunity - **Psoriasis Market**: Expected to reach $40 billion by 2030, with many patients currently underserved [6] - **Treatment Landscape**: Less than 20% of patients receive systemic treatment, and only 8% are treated with high-efficacy drugs [21] - **Patient Preferences**: 75% of patients prefer oral therapies over biologics, highlighting the demand for convenient treatment options [24] Future Developments - **NDA Filing**: Anticipated in the second half of 2026, pending data from the randomized withdrawal portion of the Phase 3 trial [37] - **Additional Trials**: Plans for a pivotal Phase 2b trial in systemic lupus erythematosus (SLE) with top-line data expected in Q3 2026 [6][28] - **Pipeline Expansion**: Development of A005, a CNS-penetrant TYK2 inhibitor, with a Phase 2 trial in multiple sclerosis planned for the first half of the year [27] Competitive Landscape - **Comparison with Competitors**: Nvudusitinib shows competitive efficacy compared to other oral therapies, including Icotrokinra and Apremilast [32][50] - **Mechanism of Action**: TYK2 inhibition may provide additional benefits beyond IL-23 and IL-17 pathways, particularly in itch reduction [51] Strategic Insights - **Market Positioning**: Alumis aims to position Nvudusitinib as a leading oral therapy for psoriasis, addressing significant unmet needs in the market [20][25] - **Partnership Considerations**: The company is evaluating strategic partnerships to maximize the asset's value, particularly in light of its broad potential across multiple indications [54] Additional Considerations - **Patient-Reported Outcomes**: Improvements in quality of life and itch were noted, which are critical factors for patient satisfaction [5][19] - **Regulatory Strategy**: Ongoing discussions with the FDA regarding the NDA filing and statistical analysis plans [38] Conclusion - **Outlook for 2026**: Alumis anticipates significant value inflection with the advancement of Nvudusitinib and its broader pipeline, aiming to address the substantial unmet needs in the treatment of psoriasis and other immune-mediated diseases [77]

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 announced that its experimental pill achieved the primary endpoint in two late-stage studies involving patients with a specific type of skin disease [1] Company Summary - The experimental pill developed by Alumis is aimed at treating a type of skin disease and has shown positive results in late-stage clinical trials [1]

– Both Phase 3 trials met all primary and secondary endpoints with high statistical significance in patients with moderate-to-severe plaque psoriasis – – Approximately 65% of patients achieved PASI 90 and more than 40% achieved PASI 100 at Week 24, on average – – Envudeucitinib demonstrated a favorable safety and tolerability profile consistent with the Phase 2 program – – Alumis plans to submit a New Drug Application to the FDA in the second half of 2026 – – Conference call and webcast scheduled for 8:00 a ...

Core Insights - Alumis Inc. is set to report topline data from the Phase 3 ONWARD clinical program for envudeucitinib in patients with moderate-to-severe plaque psoriasis on January 6, 2026 [1] - A conference call and webcast will be held on the same day at 8:00 a.m. ET to discuss the results [2] Company Overview - Alumis is a late-stage biopharma company focused on developing next-generation targeted therapies for immune-mediated diseases [3] - The company is leveraging a proprietary data analytics platform to develop a pipeline of oral tyrosine kinase 2 inhibitors, including envudeucitinib for systemic immune-mediated disorders and A-005 for neuroinflammatory diseases [3] - The pipeline also includes lonigutamab for thyroid eye disease and several preclinical programs identified through a precision approach [3]

Financial Performance - The company reported a net loss of $110.8 million for the three months ended September 30, 2025, compared to a net loss of $93.1 million for the same period in 2024, reflecting an increase in operating expenses[253]. - As of September 30, 2025, the company had an accumulated deficit of $808.9 million, primarily due to research and development costs[253]. - For the three months ended September 30, 2025, total revenue was $2.1 million, with collaboration revenue of $2.1 million and license revenue of $17.4 million for the nine months ended September 30, 2025[285]. - The net loss for the three months ended September 30, 2025, was $110.8 million, a 19% increase from a net loss of $93.1 million in the same period in 2024[284]. - The company has not generated any revenue from product sales since inception and does not expect to do so until regulatory approvals are obtained[255]. - The company does not expect to generate revenue from product sales until successful development and regulatory approval of its product candidates[316]. Expenses and Costs - Research and development expenses increased by 11% to $97.8 million for the three months ended September 30, 2025, compared to $87.8 million for the same period in 2024[286]. - General and administrative expenses rose by 85% to $19.5 million for the three months ended September 30, 2025, compared to $10.6 million for the same period in 2024[284]. - Total operating expenses for the three months ended September 30, 2025, were $117.4 million, an increase of 19% from $98.4 million in the same period in 2024[284]. - Research and development expenses for the nine months ended September 30, 2025, totaled $303.2 million, a 70% increase from $178.4 million in the same period in 2024[286]. - The company anticipates significant increases in expenses as it progresses multiple clinical trials and integrates the ACELYRIN business[254]. - The increase in research and development expenses is attributed to higher costs associated with clinical trials and professional consulting services, particularly for the envu program[288][289]. - Personnel-related costs rose by $36.6 million to $69.3 million for the nine months ended September 30, 2025, primarily due to severance costs related to the ACELYRIN Merger[296]. - CRO, CMO, and clinical trials expenses increased by $97.0 million to $187.6 million for the nine months ended September 30, 2025, driven by clinical trial progression and related expenses[294]. - General and administrative expenses surged by $52.5 million to $76.3 million for the nine months ended September 30, 2025, compared to $23.8 million for the same period in 2024[302]. Mergers and Collaborations - The company completed the ACELYRIN Merger on May 21, 2025, in a transaction valued at approximately $238.1 million, acquiring net assets with a fair value of $426.0 million[261]. - The company entered into a Collaboration Agreement with Kaken on March 25, 2025, granting Kaken exclusive rights to develop and commercialize envu in Japan, with an upfront payment of $20.0 million received[264][266]. - The company recognized a gain on bargain purchase of $187.9 million related to the ACELYRIN Merger[281]. - The company recognized a gain on bargain purchase of $187.9 million at the Closing Date of the ACELYRIN Merger[306]. Cash Flow and Funding - Cash, cash equivalents, and marketable securities totaled $377.7 million as of September 30, 2025, sufficient to meet operating and capital requirements for at least 12 months[312]. - Net cash used in operating activities was $297.6 million for the nine months ended September 30, 2025, compared to $180.3 million for the same period in 2024[318]. - Future funding requirements will depend on various factors, including clinical trial outcomes and regulatory approval processes[317]. - Net cash used in operating activities for the nine months ended September 30, 2025 was $297.6 million, compared to $180.3 million for the same period in 2024, primarily due to a net loss of $150.4 million[319]. - Net cash provided by investing activities for the nine months ended September 30, 2025 was $192.9 million, driven by proceeds from maturities of marketable securities totaling $305.4 million[324]. - Net cash provided by financing activities for the nine months ended September 30, 2025 was $0.7 million, mainly from the issuance of common stock under the 2024 Employee Stock Purchase Plan (ESPP)[326]. Obligations and Agreements - The company is obligated to pay contingent consideration of up to $120.0 million related to the acquisition of FronThera, with $23.0 million paid for a milestone achieved in August 2024[329]. - The Pierre Fabre Agreement includes potential milestone payments of up to $490.5 million and tiered royalties on worldwide net sales[333]. - As of September 30, 2025, total undiscounted lease payment obligations under non-cancelable leases were $54.9 million[336]. - Total value of non-cancellable obligations under contracts as of September 30, 2025 was $3.8 million, an increase from zero as of December 31, 2024[328]. Accounting and Financial Reporting - The company recognizes revenue based on the transaction price, which may include fixed and variable considerations such as non-refundable upfront payments and milestone payments[353]. - Revenue is allocated to distinct performance obligations based on relative standalone selling prices, considering factors like forecasted revenues and probabilities of success[354]. - Stock-based compensation expense is measured using the Black-Scholes model and is recognized on a straight-line basis over the requisite service period[356]. - The company is classified as an "emerging growth company," allowing it to delay the adoption of certain accounting standards until they apply to private companies[361]. - As of June 30, 2024, the company qualifies as a "smaller reporting company" with a market value of common stock below $700 million and annual revenue under $100 million[363]. Market and Economic Conditions - The company does not believe that a hypothetical 10% change in interest rates would materially affect its financial statements[364]. - Foreign currency transaction gains and losses have not been material, and the company does not have a formal hedging program for foreign currency[365]. - Inflation has not had a material effect on the company's business or financial condition[366].

Financial Performance - For the third quarter of 2025, Alumis reported total revenue of $2.1 million, compared to $0 for the same quarter in 2024[13]. - The net loss for Q3 2025 was $110.8 million, compared to a net loss of $93.1 million in Q3 2024[6][13]. - Alumis reported a revenue increase of 15% year-over-year, reaching $250 million in Q3 2023[15]. - The company provided guidance for Q4 2023, expecting revenue between $260 million and $270 million, indicating a potential growth of 4% to 8%[15]. - New product launch scheduled for Q1 2024, anticipated to contribute an additional $30 million in revenue[15]. - The company plans to enter the Asian market by mid-2024, targeting a revenue contribution of $50 million in the first year[15]. Research and Development - Research and development expenses increased to $97.8 million in Q3 2025, up from $87.8 million in Q3 2024, driven by higher clinical trial costs and severance expenses related to the merger with ACELYRIN[6][13]. - A-005, a novel TYK2 inhibitor, is expected to enter a Phase 2 clinical trial in multiple sclerosis in the first half of 2026[7][3]. - The company anticipates topline Phase 3 ONWARD data for envudeucitinib in moderate-to-severe plaque psoriasis to be announced in early Q1 2026[2][3]. - The company expects to establish a once-daily formulation for envudeucitinib in 2025[7][3]. - Investment in R&D increased by 25%, totaling $15 million, to enhance product offerings and technology[15]. Expenses and Costs - General and administrative expenses rose to $19.5 million in Q3 2025, compared to $10.6 million in Q3 2024, primarily due to severance costs and increased personnel-related expenses[6][13]. - Alumis recognized merger-related expenses of $6.3 million for Q3 2025, which included stock-based compensation expenses[8][6]. Market and User Growth - User base expanded to 1.5 million active users, representing a growth of 20% compared to the previous quarter[15]. - Market expansion efforts in Europe resulted in a 10% increase in market share[15]. - Customer retention rate improved to 85%, up from 80% in the previous quarter[15]. Operational Metrics - Operating margin improved to 18%, a 2% increase from the previous year[15]. - Collaboration revenue for Q3 2025 included $2.1 million from a licensing agreement with Kaken Pharmaceutical Co., Ltd.[6][13]. - As of September 30, 2025, Alumis had cash, cash equivalents, and marketable securities totaling $377.7 million, expected to support operations into 2027[9][6]. - Strategic acquisition of a tech startup completed, expected to enhance service capabilities and add $5 million in annual revenue[15].