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Olema Pharmaceuticals, Exelixis, Genmab And Other Big Stocks Moving Lower In Monday's Pre-Market Session - Addex Therapeutics (NASDAQ:ADXN), Alumis (NASDAQ:ALMS)
Benzinga· 2025-10-20 12:10
Market Overview - U.S. stock futures are higher, with Dow futures gaining approximately 0.2% on Monday [1] Company-Specific Movements - Olema Pharmaceuticals Inc (NASDAQ:OLMA) shares fell 18.3% to $7.64 in pre-market trading following the announcement of new data from the Phase 1b/2 trial of palazestrant plus ribociclib in ER+/HER2- metastatic breast cancer at ESMO 2025 [1] - Concord Medical Services Hldgs Ltd (NYSE:CCM) experienced a decline of 24.4% to $4.15 in pre-market trading after a 6% drop on Friday [3] - Addex Therapeutics Ltd – ADR (NASDAQ:ADXN) dipped 15.6% to $9.23 in pre-market trading after a significant gain of 28% on Friday [3] - Exelixis Inc (NASDAQ:EXEL) shares fell 8.3% to $36.00 after announcing detailed results from the Phase 3 STELLAR-303 pivotal trial evaluating zanzalintinib in combination with an immune checkpoint inhibitor in metastatic colorectal cancer, presented at ESMO 2025 and published in The Lancet [3] - Cellectis SA (NASDAQ:CLLS) shares declined 7.3% to $3.69 in pre-market trading [3] - Alumis Inc (NASDAQ:ALMS) saw a decline of 6.7% to $4.19 in pre-market trading [3] - Nanobiotix SA – ADR (NASDAQ:NBTX) fell 6.3% to $23.98 in pre-market trading after a 4% decline on Friday [3] - Genmab A/S – ADR (NASDAQ:GMAB) declined 4.1% to $31.81 in pre-market trading, with Rinatabart Sesutecan achieving a 50% objective response rate and two complete responses in advanced endometrial cancer [3] - Taysha Gene Therapies Inc (NASDAQ:TSHA) fell 4% to $4.53 in pre-market trading [3]
Alumis Inc. (ALMS) Presents at Stifel Virtual Immunology and Inflammation Forum Transcript
Seeking Alpha· 2025-09-17 08:53
Company Overview - Alumis is a precision immunology company that has been operational for approximately four years, focusing on a lead asset, a TYK2 inhibitor [2] - The lead asset, envudeucitinib, is being studied for psoriasis and lupus, with three clinical molecules and a research pipeline in development [2] Clinical Trials - The readout for psoriasis is expected in early Q1 of next year, with results from two Phase III trials, each involving around 850 patients [3] - The trials will assess both a 16-week endpoint against placebo and active drug, and a 24-week endpoint against active drug, positioning the company competitively in the market [3] - The readout for lupus is scheduled for the third quarter of next year, with the company currently in a Phase IIb trial for this indication [4]
Alumis (NasdaqGS:ALMS) Conference Transcript
2025-09-16 17:32
Summary of Alumis Conference Call - September 16, 2025 Company Overview - Alumis is a precision immunology company focused on developing TYK2 inhibitors, with its lead asset being ESK-001, aimed at treating psoriasis and lupus [2][4] Key Clinical Developments - ESK-001 is currently in phase 3 trials for psoriasis, with readouts expected in early Q1 next year, involving approximately 850 patients per trial [2][3] - A pivotal phase 2b trial for lupus is ongoing, with results anticipated in Q3 next year [3] - A-005, another TYK2 inhibitor, is set to enter phase 2 trials for multiple sclerosis (MS) [3] - The merger with Acceleron has provided sufficient cash to support clinical trials through 2027 [4] Mechanism and Market Potential - The TYK2 class is considered a potential multi-blockbuster class, akin to the JAK class, with evidence suggesting strong therapeutic effects against autoimmune diseases [5][6] - Genetic studies indicate that effective inhibition of TYK2 is crucial for therapeutic success, with specific mutations showing protective effects against autoimmune diseases [6][7] - The initial negative perceptions of the TYK2 class stem from early molecules that did not meet efficacy expectations, but recent data from multiple molecules, including ESK-001, show promising results [9][10] Competitive Landscape - ESK-001 is differentiated from other next-generation TYK2 inhibitors due to its favorable safety profile, allowing for higher dosing without the need for dose reductions [11][12] - The upcoming phase 3 data from Takeda's NIMUS molecule will be critical for Alumis, as it may set a new standard for efficacy and safety in psoriasis treatments [13][14] - The IL-23 receptor antagonist ixekizumab is viewed as a competitive molecule, but concerns about patient compliance with its administration may impact its market performance [15][17] Phase 3 Trial Design - The phase 3 trial design includes a 16-week primary endpoint against placebo and active control, with long-term extension for durability data [19][20] - Competitive efficacy benchmarks are set at 50%-60% at 16 weeks and 80% for PASI 75 at 24 weeks [19] Market Strategy - Alumis is considering its options for launching ESK-001, with a preference for partnership but also preparing for a potential independent launch [21][23] - The company is actively preparing for the launch, regardless of whether a partner is secured [23] Future Opportunities - The focus on systemic lupus erythematosus (SLE) is driven by the strong role of the interferon pathway, with existing data supporting TYK2's efficacy in this area [24][25] - There is potential for exploring indications in inflammatory bowel disease (IBD) and other interferon-driven diseases, although the exact dosing requirements remain a question [26][27][28] Lonigutamab and Other Programs - Lonigutamab, a new asset for thyroid eye disease, is being evaluated for its unique mechanism and market potential, although its development path is still under consideration [31][32] - The IRF5 program is in early stages, with further details to be disclosed in the future [36][37] Financial Position - The merger with Acceleron has extended Alumis's cash runway into 2027, allowing for continued investment in clinical trials and development programs [4][31]
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
Summary of Alumis Inc. Conference Call Company Overview - **Company**: Alumis Inc. (Ticker: ALMS) - **Industry**: Precision Immunology - **Key Products**: Focus on TIK2 inhibitors for autoimmune diseases, specifically psoriasis and lupus Core Points and Arguments 1. **Clinical Assets**: Alumis has three clinical assets, with a strong research organization. Currently in Phase 3 for psoriasis and Phase 2b for lupus, with read-outs expected in early Q1 and Q3 of next year respectively [2][3] 2. **TIK2 Target**: TIK2 was selected as a target due to its significant role in autoimmune diseases, with 5% of the population having mutations that provide protection against such diseases [4][5] 3. **Efficacy of Envu**: The company's TIK2 inhibitor, now called Envutucitinib (Envu), has shown a clean safety profile and high efficacy, with PASI-75 scores being the highest seen with an oral drug [8][10] 4. **Market Positioning**: The company believes that the oral drug market is underutilized, with less than 10% of diagnosed psoriasis patients on biologics. There is a strong preference for oral treatments among patients [18][19] 5. **Phase 3 Data Benchmarking**: The company is focused on long-term efficacy data (24-week and 52-week) rather than short-term results, which are more relevant for dermatologists [10][11] 6. **Lupus Opportunity**: The Phase 2b trial for lupus is pivotal, with the potential for only one Phase 3 trial if successful. The genetic evidence supports TIK2's role in lupus treatment [30][32] 7. **Trial Design**: The lupus trial includes 408 patients with strict entry criteria to minimize placebo effects, focusing on active SLE patients [35][36] 8. **Market Expansion**: There is potential to expand the systemic treatment market with better-tolerated oral drugs, targeting patients who may currently be on topical therapies [21][22] 9. **Launch Strategy**: Alumis plans to learn from competitors' launches, focusing on drug positioning, pricing, and effective communication of benefits [22][23] 10. **Cash Position**: As of the end of Q2, Alumis had $486 million in cash, expected to last into 2027, with anticipated spikes in R&D spending due to Phase 3 trial enrollment [46] Additional Important Content - **BMI Considerations**: The company acknowledges that BMI can influence drug efficacy and is a factor in cross-trial comparisons [15][16] - **Formulation Development**: Multiple formulations of Envu are being developed, with plans for a once-daily dosing regimen [28] - **Collaboration Potential**: Alumis is unlikely to launch Envu globally on its own and is considering partnerships for market entry [26][27] - **Future Indications**: The company is exploring the potential of TIK2 inhibitors in other diseases driven by interferon pathways, such as Sjogren's syndrome [33] This summary encapsulates the key points discussed during the conference call, highlighting Alumis Inc.'s strategic focus, clinical developments, and market opportunities in the precision immunology sector.
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
[PART I—FINANCIAL INFORMATION](index=6&type=section&id=Part%20I%20Financial%20Information) This section presents Alumis Inc.'s unaudited condensed consolidated financial statements and management's discussion and analysis [Item 1. Financial Statements (Unaudited)](index=6&type=section&id=Item%201.%20Financial%20Statements%20(Unaudited)) Alumis Inc.'s unaudited condensed consolidated financial statements and notes detail financial position and performance [Condensed Consolidated Balance Sheets](index=6&type=section&id=Condensed%20Consolidated%20Balance%20Sheets) Alumis Inc.'s financial position is presented, detailing assets, liabilities, and stockholders' equity at specific dates | (in thousands) | June 30, 2025 | December 31, 2024 | | :--------------------------------- | :------------ | :---------------- | | **Assets** | | | | Cash and cash equivalents | $ 151,753 | $ 169,526 | | Marketable securities | 334,568 | 118,737 | | Total current assets | 517,558 | 306,188 | | Total assets | $ 610,925 | $ 340,992 | | **Liabilities and Stockholders' Equity** | | | | Total current liabilities | 85,575 | 50,910 | | Total liabilities | 125,598 | 80,888 | | Total stockholders' equity | 485,327 | 260,104 | | Total liabilities and stockholders' equity | $ 610,925 | $ 340,992 | [Condensed Consolidated Statements of Operations and Comprehensive Income (Loss)](index=8&type=section&id=Condensed%20Consolidated%20Statements%20of%20Operations%20and%20Comprehensive%20Income%20(Loss)) Alumis Inc.'s revenues, expenses, and net income or loss are outlined over specific reporting periods | (in thousands, except share and per share amounts) | Three Months Ended June 30, 2025 | Three Months Ended June 30, 2024 | Six Months Ended June 30, 2025 | Six Months Ended June 30, 2024 | | :------------------------------------------------- | :------------------------------- | :------------------------------- | :----------------------------- | :----------------------------- | | **Revenue:** | | | | | | License revenue | $ — | $ — | $ 17,389 | $ — | | Collaboration revenue | 2,666 | — | 2,666 | — | | Total revenue | 2,666 | — | 20,055 | — | | **Operating expenses:** | | | | | | Research and development expenses | 108,755 | 48,565 | 205,377 | 90,526 | | General and administrative expenses | 34,450 | 7,575 | 56,745 | 13,207 | | Total operating expenses | 143,205 | 56,140 | 262,122 | 103,733 | | Loss from operations | (140,539) | (56,140) | (242,067) | (103,733) | | **Other income (expense):** | | | | | | Gain on bargain purchase | 187,907 | — | 187,907 | — | | Interest income | 3,430 | 1,977 | 6,039 | 2,831 | | Change in fair value of derivative liability | — | (2,311) | — | (5,406) | | Total other income (expense), net | 191,299 | (368) | 193,864 | (2,624) | | Net income (loss) before income taxes | 50,760 | (56,508) | (48,203) | (106,357) | | Income tax benefit | 8,561 | — | 8,561 | — | | Net income (loss) | $ 59,321 | $ (56,508) | $ (39,642) | $ (106,357) | | Net income (loss) per share, basic | $ 0.78 | $ (23.10) | $ (0.61) | $ (44.17) | | Net income (loss) per share, diluted | $ 0.77 | $ (23.10) | $ (0.61) | $ (44.17) | [Condensed Consolidated Statements of Redeemable Convertible Preferred Stock and Stockholders' Equity (Deficit)](index=9&type=section&id=Condensed%20Consolidated%20Statements%20of%20Redeemable%20Convertible%20Preferred%20Stock%20and%20Stockholders'%20Equity%20(Deficit)) Changes in Alumis Inc.'s redeemable convertible preferred stock and stockholders' equity are detailed over time - Total stockholders' equity increased from **$260.1 million** as of December 31, 2024, to **$485.3 million** as of June 30, 2025, primarily driven by the ACELYRIN Merger and stock-based compensation[23](index=23&type=chunk) - The ACELYRIN Merger resulted in the issuance of **48,653,549 common shares** and an increase of **$238.1 million** in additional paid-in capital[23](index=23&type=chunk) - Net income for the three months ended June 30, 2025, was **$59.3 million**, contributing to the change in accumulated deficit[23](index=23&type=chunk) [Condensed Consolidated Statements of Cash Flows](index=10&type=section&id=Condensed%20Consolidated%20Statements%20of%20Cash%20Flows) Alumis Inc.'s cash inflows and outflows from operating, investing, and financing activities are presented | (in thousands) | Six Months Ended June 30, 2025 | Six Months Ended June 30, 2024 | | :--------------------------------------- | :----------------------------- | :----------------------------- | | Net cash used in operating activities | $ (186,707) | $ (96,548) | | Net cash provided by (used in) investing activities | 168,828 | (51,551) | | Net cash provided by financing activities | 749 | 257,211 | | Net (decrease) increase in cash, cash equivalents and restricted cash | $ (17,130) | $ 109,112 | | Cash, cash equivalents and restricted cash at end of period | $ 153,502 | $ 156,245 | [Notes to Condensed Consolidated Financial Statements](index=11&type=section&id=Notes%20to%20Condensed%20Consolidated%20Financial%20Statements) Detailed explanations and disclosures supporting the condensed consolidated financial statements are provided [1. Organization and Nature of the Business](index=11&type=section&id=1.%20Organization%20and%20Nature%20of%20the%20Business) Alumis Inc. is a clinical-stage biopharmaceutical company focused on autoimmune disorders, with an accumulated deficit of **$698.2 million** - Alumis Inc. is a clinical stage biopharmaceutical company focused on identifying, acquiring, and accelerating the development and commercialization of transformative medicines for autoimmune disorders[29](index=29&type=chunk) - The company completed the ACELYRIN Merger on May 21, 2025, acquiring ACELYRIN as a wholly owned subsidiary[36](index=36&type=chunk) - As of June 30, 2025, the Company had an accumulated deficit of **$698.2 million** and expects existing cash, cash equivalents, and marketable securities of **$486.3 million** to be sufficient for at least 12 months[37](index=37&type=chunk)[38](index=38&type=chunk) [2. Summary of Significant Accounting Policies and Basis of Presentation](index=13&type=section&id=2.%20Summary%20of%20Significant%20Accounting%20Policies%20and%20Basis%20of%20Presentation) Alumis Inc.'s significant accounting policies, including basis of presentation, business combinations, revenue, and stock-based compensation - The condensed consolidated financial statements are prepared in accordance with U.S. GAAP and include accounts of subsidiaries, with intercompany transactions eliminated[44](index=44&type=chunk)[45](index=45&type=chunk) - The Company operates and manages its business as one reportable and operating segment, focused on researching and developing medicines for autoimmune disorders[50](index=50&type=chunk) - Business combinations are accounted for using the acquisition method, recording acquired assets and assumed liabilities at fair value, with any excess of net assets over consideration recognized as a gain on bargain purchase[57](index=57&type=chunk) - Revenue from collaboration agreements is recognized following a five-step approach under ASC 606, allocating transaction price to distinct performance obligations based on standalone selling price[67](index=67&type=chunk)[72](index=72&type=chunk) - Stock-based compensation expense is measured at fair value using the Black-Scholes or Monte Carlo models and recognized over the requisite service period[74](index=74&type=chunk)[75](index=75&type=chunk) - The Company recognized an income tax benefit of **$8.6 million** for the three and six months ended June 30, 2025, primarily due to the realization of deferred tax assets and valuation allowance release from the ACELYRIN Merger[84](index=84&type=chunk) [3. Acquisitions](index=25&type=section&id=3.%20Acquisitions) The ACELYRIN Merger on May 21, 2025, for **$238.1 million** in common stock, resulted in a **$187.9 million** gain on bargain purchase - Alumis completed the ACELYRIN Merger on May 21, 2025, acquiring ACELYRIN, a late-stage biopharma company, in a common stock transaction valued at approximately **$238.1 million**[36](index=36&type=chunk)[91](index=91&type=chunk)[96](index=96&type=chunk) - The merger resulted in the issuance of **48,653,549 shares** of Alumis common stock and the assumption of ACELYRIN's stock options and RSUs[92](index=92&type=chunk) - A preliminary gain on bargain purchase of **$187.9 million** was recognized, as the fair value of net assets acquired (**$426.0 million**) exceeded the purchase consideration (**$238.1 million**)[97](index=97&type=chunk)[104](index=104&type=chunk) - The acquired intangible assets primarily consist of the IPR&D asset related to lonigutamab, valued at **$51.0 million**[101](index=101&type=chunk) Unaudited Pro Forma Summary of Operations (Six Months Ended June 30) | | 2025 (in thousands) | 2024 (in thousands) | | :---------------------- | :------------------ | :------------------ | | Total revenue | $ 20,055 | $ — | | Net income (loss) | (276,520) | (79,508) | [4. Fair Value Measurements](index=32&type=section&id=4.%20Fair%20Value%20Measurements) Alumis Inc.'s financial assets are categorized into Level 1, Level 2, and Level 3 fair value measurements - The Company classifies financial instruments into Level 1 (quoted prices in active markets), Level 2 (observable inputs other than Level 1 prices), and Level 3 (unobservable inputs)[115](index=115&type=chunk)[116](index=116&type=chunk) Fair Value Hierarchy for Financial Assets (June 30, 2025) | (in thousands) | Level 1 | Level 2 | Level 3 | Total | | :------------- | :--------- | :--------- | :------ | :--------- | | Cash equivalents | $148,040 | $ — | $ — | $148,040 | | Marketable securities | 146,158 | 188,410 | — | 334,568 | | Total assets | $294,198 | $188,410 | $ — | $482,608 | - For the three and six months ended June 30, 2025, the Company did not have any Level 3 financial instruments[126](index=126&type=chunk) - In 2024, Level 3 financial instruments included derivative liabilities from Series C redeemable convertible preferred stock financing, which were settled in May 2024[119](index=119&type=chunk)[126](index=126&type=chunk) [5. Marketable Securities](index=34&type=section&id=5.%20Marketable%20Securities) Alumis Inc.'s marketable securities significantly increased to **$334.6 million** by June 30, 2025 Marketable Securities (in thousands) | | June 30, 2025 | December 31, 2024 | | :-------------------------- | :------------ | :---------------- | | U.S. treasuries | $281,241 | $118,737 | | Corporate debt obligations | 46,373 | — | | Federal agency obligations | 4,851 | — | | Supranational bonds | 2,103 | — | | Total marketable securities | $334,568 | $118,737 | - All marketable securities held as of June 30, 2025, and December 31, 2024, had contractual maturities of less than one year[130](index=130&type=chunk) - The Company determined that the decline in fair value below amortized cost basis for marketable securities was immaterial and non-credit related, with no allowance for expected credit losses recorded[131](index=131&type=chunk) [6. Balance Sheet Components](index=35&type=section&id=6.%20Balance%20Sheet%20Components) Specific balance sheet components, including restricted cash, prepaid expenses, and property and equipment, net, are detailed - Restricted cash increased from **$1.1 million** at December 31, 2024, to **$1.8 million** at June 30, 2025, primarily due to collateral for lease commitments and a corporate credit program[132](index=132&type=chunk) Other Prepaid Expenses and Current Assets (in thousands) | | June 30, 2025 | December 31, 2024 | | :------------------------------------ | :------------ | :---------------- | | Prepaid credit voucher for clinical manufacturing | $ 10,754 | $ — | | Service and other revenue receivable | 2,666 | — | | Interest receivable | 2,267 | 698 | | Total other prepaid expenses and current assets | $ 23,861 | $ 4,501 | - The prepaid credit voucher for clinical manufacturing, acquired by ACELYRIN in Q3 2024, is valued at **$10.8 million** and will be used for lonigutamab manufacturing invoices[133](index=133&type=chunk) Property and Equipment, Net (in thousands) | | June 30, 2025 | December 31, 2024 | | :--------------------------------- | :------------ | :---------------- | | Total property and equipment, gross | $ 26,972 | $ 25,525 | | Less: Accumulated depreciation and amortization | (6,644) | (4,557) | | Total property and equipment, net | $ 20,328 | $ 20,968 | Other Accrued Expenses and Current Liabilities (in thousands) | | June 30, 2025 | December 31, 2024 | | :------------------------------------ | :------------ | :---------------- | | Accrued personnel and related expenses | $ 9,845 | $ 7,765 | | Accrued professional services | 9,609 | 2,657 | | Severance liability | 3,003 | — | | Total other accrued expenses and current liabilities | $ 22,805 | $ 10,580 | [7. Revenue](index=36&type=section&id=7.%20Revenue) Alumis Inc. recognized **$20.1 million** in total revenue for the six months ended June 30, 2025, from a collaboration and license agreement - On March 25, 2025, Alumis Inc. entered into a collaboration and license agreement with Kaken Pharmaceutical Co., Ltd. for envudeucitinib (envu) in dermatology indications in Japan[138](index=138&type=chunk)[139](index=139&type=chunk) - Kaken made an upfront, non-refundable payment of **$20.0 million** and will contribute **$20.0 million** towards global development costs through 2026[142](index=142&type=chunk) - Potential future payments include up to **$36.0 million** for regulatory milestones and field expansion options, and up to **¥15.5 billion** for commercial milestones, plus tiered royalties[142](index=142&type=chunk) - The Company recognized **$17.4 million** in license revenue and **$2.7 million** in collaboration revenue for the six months ended June 30, 2025[147](index=147&type=chunk) [8. Related Party Transactions](index=40&type=section&id=8.%20Related%20Party%20Transactions) Alumis Inc. has a services agreement with Foresite Labs, an affiliate of a significant stockholder - Alumis Inc. has a services agreement with Foresite Labs, an affiliate of a stockholder, for exploring specified immunology genetic targets[152](index=152&type=chunk) - Research and development expenses under this agreement were **$0.3 million** for the three months ended June 30, 2025, and **$0.5 million** for the six months ended June 30, 2025[152](index=152&type=chunk) [9. Commitments and Contingent Liabilities](index=40&type=section&id=9.%20Commitments%20and%20Contingent%20Liabilities) Alumis Inc. has various commitments and contingent liabilities, including operating leases and contingent consideration - Alumis Inc. has operating lease agreements for office and laboratory space in South San Francisco and Southern California, with total undiscounted lease payments of **$56.9 million** as of June 30, 2025[153](index=153&type=chunk)[158](index=158&type=chunk)[159](index=159&type=chunk)[164](index=164&type=chunk) - The company has contingent consideration obligations from the FronThera Acquisition, with up to **$120.0 million** based on clinical and approval milestones for envu[165](index=165&type=chunk) - Upon the ACELYRIN Merger, Alumis assumed obligations under the Pierre Fabre Agreement, including potential development, regulatory, and commercial milestone payments up to **$100.5 million** and **$390.0 million**, respectively, plus tiered royalties[166](index=166&type=chunk)[167](index=167&type=chunk) - A federal securities class action lawsuit against ACELYRIN was assumed, alleging misleading investors about a Phase 2b trial. The outcome is uncertain, and no probable loss has been estimated[175](index=175&type=chunk)[179](index=179&type=chunk) [10. Redeemable Convertible Preferred Stock](index=48&type=section&id=10.%20Redeemable%20Convertible%20Preferred%20Stock) Alumis Inc. issued Series C redeemable convertible preferred stock in 2024, which converted to common stock prior to the IPO - In March 2024, the Company issued **41,264,891 shares** of Series C redeemable convertible preferred stock for gross proceeds of **$129.5 million**[181](index=181&type=chunk) - An additional **41,264,892 shares** of Series C preferred stock were issued in May 2024 for **$129.5 million**, settling derivative liabilities of **$14.3 million**[182](index=182&type=chunk) - Immediately prior to the IPO on July 1, 2024, all outstanding redeemable convertible preferred stock converted into voting and non-voting common stock[183](index=183&type=chunk) [11. Stockholders' Equity](index=49&type=section&id=11.%20Stockholders'%20Equity) As of June 30, 2025, Alumis Inc. had **96.9 million** voting and **7.2 million** non-voting common shares outstanding - As of June 30, 2025, Alumis Inc. had **96,857,569 voting common shares** and **7,184,908 non-voting common shares** outstanding, both with a **$0.0001** par value[186](index=186&type=chunk) - Non-voting common stock holders have the right to convert to voting common stock, subject to a **4.99%** beneficial ownership limit[187](index=187&type=chunk) Common Stock Reserved for Issuance (as-converted basis, June 30, 2025) | | June 30, 2025 | | :------------------------------------------------- | :------------ | | Stock options issued and outstanding | 18,190,124 | | RSUs issued and outstanding | 672,117 | | Shares available for grant under the 2024 Equity Incentive Plan | 5,430,350 | | Shares available for grant under the 2024 Employee Stock Purchase Plan | 1,009,440 | | Shares available for grant under the ACELYRIN, Inc. 2023 Equity Incentive Plan | 6,321,733 | | Shares available for grant under the 2024 Performance Option Plan | 98,681 | | Total | 31,722,445 | [12. Stock-Based Compensation](index=50&type=section&id=12.%20Stock-Based%20Compensation) Alumis Inc. utilizes various stock plans, with stock-based compensation expense significantly increasing due to the ACELYRIN Merger - In March 2024, the Company repriced outstanding stock options with an exercise price exceeding **$8.84 per share**, reducing the weighted average exercise price to **$8.84** and resulting in **$0.7 million** incremental expense[195](index=195&type=chunk)[196](index=196&type=chunk) - The 2024 EIP, effective June 2024, reserved **7,800,000 new shares** and includes an evergreen provision for annual increases[202](index=202&type=chunk) - The ACELYRIN Merger resulted in the assumption of ACELYRIN's stock options, RSUs, and performance RSUs, with performance RSUs deemed **100% satisfied** for performance conditions[204](index=204&type=chunk)[205](index=205&type=chunk) Stock-Based Compensation Expense (in thousands) | | Three Months Ended June 30, 2025 | Three Months Ended June 30, 2024 | Six Months Ended June 30, 2025 | Six Months Ended June 30, 2024 | | :-------------------------------- | :------------------------------- | :------------------------------- | :----------------------------- | :----------------------------- | | Research and development | $ 7,225 | $ 1,641 | $ 10,944 | $ 3,085 | | General and administrative | 11,410 | 1,492 | 14,686 | 2,705 | | Total stock-based compensation expense | $ 18,635 | $ 3,133 | $ 25,630 | $ 5,790 | - As of June 30, 2025, unrecognized stock-based compensation expense was **$62.0 million**, expected to be recognized over a weighted-average period of **2.5 years**[236](index=236&type=chunk) [13. Employee Benefit Plans](index=59&type=section&id=13.%20Employee%20Benefit%20Plans) Alumis Inc. sponsors a qualified 401(k) defined contribution plan, with no employer contributions made for the reported periods - The Company sponsors a qualified 401(k) defined contribution plan for eligible employees[239](index=239&type=chunk) - No employer contributions were made to the 401(k) plan for the three and six months ended June 30, 2025, and 2024[239](index=239&type=chunk) [14. Net Income (Loss) Per Share Attributable to Common Stockholders](index=59&type=section&id=14.%20Net%20Income%20(Loss)%20Per%20Share%20Attributable%20to%20Common%20Stockholders) Alumis Inc. reported basic net income per share of **$0.78** for Q2 2025, with potentially dilutive securities excluded when antidilutive Net Income (Loss) Per Share Attributable to Common Stockholders | | Three Months Ended June 30, 2025 | Three Months Ended June 30, 2024 | Six Months Ended June 30, 2025 | Six Months Ended June 30, 2024 | | :------------------------------------------------- | :------------------------------- | :------------------------------- | :----------------------------- | :----------------------------- | | Net income (loss) | $ 59,321 | $ (56,508) | $ (39,642) | $ (106,357) | | Weighted-average shares of common stock outstanding, basic | 76,477,144 | 2,446,022 | 65,440,021 | 2,408,037 | | Weighted-average shares of common stock outstanding, diluted | 76,635,895 | 2,446,022 | 65,440,021 | 2,408,037 | | Net income (loss) per share, basic | $ 0.78 | $ (23.10) | $ (0.61) | $ (44.17) | | Net income (loss) per share, diluted | $ 0.77 | $ (23.10) | $ (0.61) | $ (44.17) | - Potentially dilutive securities, including stock options, RSUs, and early exercised stock options, were excluded from diluted EPS computation when their inclusion would have been antidilutive[240](index=240&type=chunk) [15. Segment Reporting](index=60&type=section&id=15.%20Segment%20Reporting) Alumis Inc. operates as a single reportable segment focused on autoimmune disorders, with R&D expenses significantly increasing - The Company operates and manages its business as one reportable and operating segment, focused on researching and developing medicines for autoimmune disorders[243](index=243&type=chunk) Disaggregated Research and Development Expenses (in thousands) | | Three Months Ended June 30, 2025 | Three Months Ended June 30, 2024 | Six Months Ended June 30, 2025 | Six Months Ended June 30, 2024 | | :-------------------------------- | :------------------------------- | :------------------------------- | :----------------------------- | :----------------------------- | | CROs, CMOs and clinical trials | $ 66,089 | $ 26,849 | $ 131,162 | $ 51,113 | | Professional consulting services | 7,417 | 4,765 | 13,821 | 8,290 | | Other research and development costs | 2,995 | 3,597 | 5,291 | 5,594 | | Personnel-related costs | 26,821 | 10,134 | 44,479 | 19,229 | | Facilities and overhead costs | 5,433 | 3,220 | 10,624 | 6,300 | | Total research and development expense | $ 108,755 | $ 48,565 | $ 205,377 | $ 90,526 | [16. Subsequent Events](index=60&type=section&id=16.%20Subsequent%20Events) The One Big Beautiful Bill Act (OBBBA) was enacted on July 4, 2025, with Alumis Inc. evaluating its financial impact - The One Big Beautiful Bill Act (OBBBA) was enacted on July 4, 2025, modifying capitalization of R&D expenses and accelerating fixed asset depreciation[245](index=245&type=chunk) - The Company is currently assessing the impact of the OBBBA on its consolidated financial statements and disclosures[245](index=245&type=chunk) [Item 2. Management's Discussion and Analysis of Financial Condition and Results of Operations](index=61&type=section&id=Item%202.%20Management's%20Discussion%20and%20Analysis%20of%20Financial%20Condition%20and%20Results%20of%20Operations) Alumis Inc.'s financial condition and results of operations are analyzed, covering revenue, expenses, the ACELYRIN Merger, and future funding - Alumis is a clinical-stage biopharmaceutical company focused on developing TYK2 inhibitors (envudeucitinib and A-005) for autoimmune and neuroinflammatory disorders, and lonigutamab for Thyroid Eye Disease (acquired via ACELYRIN Merger)[248](index=248&type=chunk) - The company incurred net income of **$59.3 million** for the three months ended June 30, 2025, but a net loss of **$(39.6) million** for the six months ended June 30, 2025, with an accumulated deficit of **$698.2 million**[252](index=252&type=chunk) - Total revenue for the six months ended June 30, 2025, was **$20.1 million**, primarily from a license and collaboration agreement with Kaken Pharmaceutical Co., Ltd[283](index=283&type=chunk) - Research and development expenses increased by **127%** to **$205.4 million** for the six months ended June 30, 2025, driven by clinical trial progression and manufacturing[283](index=283&type=chunk)[292](index=292&type=chunk) - General and administrative expenses increased by **330%** to **$56.7 million** for the six months ended June 30, 2025, largely due to ACELYRIN Merger transaction costs and increased headcount[283](index=283&type=chunk)[302](index=302&type=chunk)[304](index=304&type=chunk) - A gain on bargain purchase of **$187.9 million** was recognized in Q2 2025 due to the ACELYRIN Merger[306](index=306&type=chunk) - The company expects to incur significant and increasing expenses and substantial losses for the foreseeable future, requiring additional capital beyond its current **$486.3 million** in cash, cash equivalents, and marketable securities[249](index=249&type=chunk)[311](index=311&type=chunk)[312](index=312&type=chunk) [Item 3. Quantitative and Qualitative Disclosures about Market Risk](index=94&type=section&id=Item%203.%20Quantitative%20and%20Qualitative%20Disclosures%20about%20Market%20Risk) Alumis Inc. is exposed to market risks from interest rate and foreign currency fluctuations, but no material financial impact is anticipated - The Company is exposed to market risks from changes in interest rates on cash equivalents and marketable securities, but a hypothetical **10%** change is not expected to have a material effect[359](index=359&type=chunk) - Foreign currency exchange risk exists due to international CRO and CMO vendors, but foreign currency transaction gains and losses have not been material, and no formal hedging program is in place[360](index=360&type=chunk) - Inflation affects labor and R&D costs, but has not had a material effect on the business, results of operations, or financial condition[361](index=361&type=chunk) [Item 4. Controls and Procedures](index=94&type=section&id=Item%204.%20Controls%20and%20Procedures) Alumis Inc.'s disclosure controls and procedures were deemed effective as of June 30, 2025, with no material changes in internal control - As of June 30, 2025, management, with CEO and CFO participation, concluded that disclosure controls and procedures were effective[362](index=362&type=chunk)[363](index=363&type=chunk)[364](index=364&type=chunk) - No material changes in internal control over financial reporting occurred during the quarter ended June 30, 2025[365](index=365&type=chunk) - Management recognizes that all control systems have inherent limitations and can only provide reasonable, not absolute, assurance of achieving control objectives[366](index=366&type=chunk) [PART II—OTHER INFORMATION](index=97&type=section&id=Part%20II%20Other%20Information) This section provides additional information, including legal proceedings, risk factors, equity sales, and exhibits [Item 1. Legal Proceedings](index=97&type=section&id=Item%201.%20Legal%20Proceedings) Alumis Inc. assumed a federal securities class action lawsuit against ACELYRIN, with an uncertain outcome and no probable loss - A federal securities class action lawsuit was commenced against ACELYRIN on November 15, 2023, alleging misleading investors about the Phase 2b trial of izokibep[369](index=369&type=chunk) - The lawsuit seeks damages and an award of reasonable costs and expenses, and a motion to dismiss the amended complaint is pending[369](index=369&type=chunk) - The Company cannot estimate the possible loss from this lawsuit, as it is in an early stage, and has not accrued for any potential liability[179](index=179&type=chunk) [Item 1A. Risk Factors](index=97&type=section&id=Item%201A.%20Risk%20Factors) Investing in Alumis Inc. common stock involves high risk due to its clinical-stage nature, financing needs, development uncertainties, and competition - Alumis is a clinical-stage biopharmaceutical company with no products approved for commercial sale, incurring substantial losses and anticipating increasing losses for the foreseeable future[377](index=377&type=chunk)[379](index=379&type=chunk) - The company will require substantial additional financing to achieve its goals, and failure to obtain capital could delay or terminate product development and commercialization efforts[374](index=374&type=chunk)[390](index=390&type=chunk) - Preclinical and clinical development is lengthy, expensive, and uncertain, with results from earlier studies not always predictive of future trial outcomes, potentially leading to delays or inability to complete development[374](index=374&type=chunk)[393](index=393&type=chunk)[395](index=395&type=chunk) - Clinical trials may reveal serious adverse events (SAEs) and significant adverse events (AEs) not previously seen, potentially delaying or preventing regulatory approval or market acceptance[374](index=374&type=chunk)[403](index=403&type=chunk)[405](index=405&type=chunk) - The company faces significant competition from large and specialty pharmaceutical and biotechnology companies, many with greater resources and approved therapies[374](index=374&type=chunk)[431](index=431&type=chunk)[436](index=436&type=chunk) - Risks related to the ACELYRIN Merger include integration difficulties, diversion of management attention, and the possibility that anticipated benefits may not be fully realized[374](index=374&type=chunk)[438](index=438&type=chunk)[440](index=440&type=chunk) - Failure to obtain and maintain sufficient intellectual property protection, or challenges to existing patents, could allow competitors to commercialize similar products, adversely affecting the business[374](index=374&type=chunk)[522](index=522&type=chunk)[523](index=523&type=chunk) - The regulatory approval processes are lengthy, time-consuming, and unpredictable, with no guarantee of approval for product candidates[374](index=374&type=chunk)[448](index=448&type=chunk) [Item 2. Unregistered Sales of Equity Securities and Use of Proceeds](index=223&type=section&id=Item%202.%20Unregistered%20Sales%20of%20Equity%20Securities%20and%20Use%20of%20Proceeds) Alumis Inc. completed a private placement on July 17, 2024, issuing **2.5 million** common shares at **$16.00** per share - On July 17, 2024, Alumis Inc. completed a concurrent private placement, selling **2,500,000 shares** of common stock at **$16.00 per share** to AyurMaya Capital Management Fund, LP[257](index=257&type=chunk)[700](index=700&type=chunk)[702](index=702&type=chunk) - The sale was exempt from registration under Section 4(a)(2) of the Securities Act, with the recipient acquiring shares for investment purposes[700](index=700&type=chunk) - Net proceeds from the IPO and the concurrent private placement have been invested in money market funds and high-quality, available-for-sale marketable securities, with no material change in planned use[703](index=703&type=chunk) [Item 3. Defaults Upon Senior Securities](index=225&type=section&id=Item%203.%20Defaults%20Upon%20Senior%20Securities) Alumis Inc. reported no defaults upon senior securities for the period - There were no defaults upon senior securities[704](index=704&type=chunk) [Item 4. Mine Safety Disclosures](index=225&type=section&id=Item%204.%20Mine%20Safety%20Disclosures) This item is not applicable to Alumis Inc - This item is not applicable[705](index=705&type=chunk) [Item 5. Other Information](index=225&type=section&id=Item%205.%20Other%20Information) Alumis Inc. reported no other information for the period - There is no other information to report[706](index=706&type=chunk) [Item 6. Exhibits](index=225&type=section&id=Item%206.%20Exhibits) All exhibits filed with the Quarterly Report on Form 10-Q, including merger agreements, organizational documents, and certifications, are listed - Exhibits include the Agreement and Plan of Merger with ACELYRIN, Inc. and its amendment, and the Amended and Restated Certificate of Incorporation and Bylaws of the Registrant[707](index=707&type=chunk) - Certifications from the Principal Executive Officer and Principal Financial Officer are included pursuant to Sections 302 and 906 of the Sarbanes-Oxley Act of 2002[707](index=707&type=chunk) - XBRL Instance Document and Taxonomy Extension Documents (Schema, Calculation, Definition, Label, Presentation Linkbase) are also filed[707](index=707&type=chunk)[709](index=709&type=chunk) [SIGNATURES](index=228&type=section&id=Signatures) This section contains the official signatures for the Quarterly Report on Form 10-Q [Signatures](index=228&type=section&id=Signatures) The Quarterly Report on Form 10-Q is signed by Alumis Inc.'s President and CEO, and CFO - The report is signed by Martin Babler, President and Chief Executive Officer, and John Schroer, Chief Financial Officer, on August 13, 2025[712](index=712&type=chunk)
Alumis Inc.(ALMS) - 2025 Q2 - Quarterly Results
2025-08-13 20:14
[Alumis Reports Second Quarter 2025 Financial Results and Provides Corporate Update](index=1&type=section&id=Report%20Overview) Alumis announced Q2 2025 financial results, highlighted clinical milestones for envudeucitinib, pipeline updates, and the completion of the ACELYRIN merger [Second Quarter 2025 and Recent Highlights, and Anticipated Milestones](index=1&type=section&id=Second%20Quarter%202025%20and%20Recent%20Highlights%2C%20and%20Anticipated%20Milestones) Alumis achieved key clinical milestones for envudeucitinib in Q2 2025, with Phase 3 ONWARD and Phase 2b LUMUS enrollment complete, and strengthened finances via the ACELYRIN merger [Envudeucitinib Progress](index=1&type=section&id=Envudeucitinib%20Progress) Envudeucitinib achieved full patient enrollment in pivotal Phase 3 ONWARD and Phase 2b LUMUS trials, with topline data expected in early Q1 2026 and Q3 2026, respectively - **Envudeucitinib** is the generic name for investigational therapy ESK-001[3](index=3&type=chunk) - Completed patient enrollment in Phase 2b LUMUS trial for SLE (408 patients), with topline data expected in **Q3 2026**[3](index=3&type=chunk)[7](index=7&type=chunk) - Completed patient enrollment in pivotal Phase 3 ONWARD program for plaque psoriasis, with topline data expected in **early Q1 2026**[7](index=7&type=chunk) [Pipeline Updates](index=2&type=section&id=Pipeline%20Updates) Alumis' pipeline advanced with A-005 entering Phase 2 for multiple sclerosis, a third program's Phase 1 data expected, and Lonigutamab receiving FDA Fast Track Designation for TED - **A-005**, a CNS-penetrant TYK2 inhibitor, is expected to enter a Phase 2 trial for multiple sclerosis in **H1 2026**[7](index=7&type=chunk) - Phase 1 clinical data from a third development program, targeting immune-mediated disease drivers, is anticipated in **H2 2026**[7](index=7&type=chunk) - **Lonigutamab**, an anti-IGF-1R therapy for thyroid eye disease (TED), received **FDA Fast Track Designation**[7](index=7&type=chunk) [Corporate Highlights](index=2&type=section&id=Corporate%20Highlights) Sanam Pangali was promoted to Chief Legal Officer, and Alumis completed its merger with ACELYRIN, Inc. to bolster financial strength and pipeline advancement - Sanam Pangali was promoted to **Chief Legal Officer and Corporate Secretary**[7](index=7&type=chunk) - Completed merger with **ACELYRIN, Inc.** to strengthen financial position and advance the late-stage immunology pipeline[1](index=1&type=chunk)[2](index=2&type=chunk)[7](index=7&type=chunk) [Financial Review](index=4&type=section&id=Financial%20Review) Alumis' Q2 2025 financial review details net income, R&D and G&A expenses, cash position, and future financial guidance [Second Quarter 2025 Financial Results](index=4&type=section&id=Second%20Quarter%202025%20Financial%20Results) Alumis reported **$59.3 million net income** in Q2 2025, driven by a merger gain, with increased R&D and G&A expenses, and **$486.3 million** in cash and equivalents | Metric | Q2 2025 (Millions USD) | Q2 2024 (Millions USD) | Change (YoY) | | :----- | :--------------------- | :--------------------- | :----------- | | Total Revenue | $2.7 | $0 | +$2.7M | | R&D Expenses | $108.8 | $48.6 | +$60.2M | | G&A Expenses | $34.5 | $7.6 | +$26.9M | | Net Income (Loss) | $59.3 | $(56.5) | +$115.8M | | Gain on bargain purchase | $187.9 | $0 | +$187.9M | - Cash, cash equivalents, and marketable securities totaled **$486.3 million** as of June 30, 2025[1](index=1&type=chunk)[10](index=10&type=chunk) - R&D expenses increased due to higher contract research and clinical trial costs, Phase 3 ONWARD acceleration, severance, stock-based compensation from the ACELYRIN merger, and increased headcount[10](index=10&type=chunk) - G&A expenses rose due to transaction costs, severance costs, stock-based compensation from the ACELYRIN merger, and increased personnel and professional consulting services[10](index=10&type=chunk) - The ACELYRIN merger contributed **$382.6 million** in cash, cash equivalents, and marketable securities at closing[10](index=10&type=chunk) [Financial Guidance](index=4&type=section&id=Financial%20Guidance) Alumis expects R&D expenses to decrease in late 2025, with **$486.3 million** in cash and equivalents projected to fund operations into 2027 - Alumis expects research and development expenses to decrease for the remaining quarters of **2025**[9](index=9&type=chunk) - Existing cash, cash equivalents, and marketable securities of **$486.3 million** as of June 30, 2025, are expected to fund operations into **2027**[1](index=1&type=chunk)[9](index=9&type=chunk)[10](index=10&type=chunk) [Corporate Information](index=4&type=section&id=Corporate%20Information) This section provides details on Alumis' upcoming investor events, company overview, and standard forward-looking statements [Upcoming Events](index=4&type=section&id=Upcoming%20Events) Alumis plans to participate in multiple investor conferences in September 2025, including Cantor, Wells Fargo, Morgan Stanley, H.C. Wainwright, Baird, and Stifel - Alumis expects to participate in multiple investor conferences in **September 2025**, including Cantor, Wells Fargo, Morgan Stanley, H.C. Wainwright, Baird, and Stifel healthcare conferences[10](index=10&type=chunk)[11](index=11&type=chunk)[14](index=14&type=chunk) [About Alumis](index=5&type=section&id=About%20Alumis) Alumis is a clinical-stage biopharmaceutical company developing targeted therapies for immune-mediated diseases, leveraging a data analytics platform to advance its pipeline of TYK2 inhibitors and lonigutamab - Alumis is a clinical-stage biopharmaceutical company developing next-generation targeted therapies for immune-mediated diseases[1](index=1&type=chunk)[12](index=12&type=chunk) - The company's pipeline includes oral **TYK2 inhibitors** envudeucitinib (plaque psoriasis, SLE) and A-005 (neuroinflammatory/neurodegenerative diseases), plus lonigutamab (thyroid eye disease) and preclinical programs[12](index=12&type=chunk) [Forward-Looking Statements](index=5&type=section&id=Forward-Looking%20Statements) This section outlines forward-looking statements regarding clinical trials, cash runway, and events, noting that actual results may differ due to inherent risks and uncertainties - The press release includes forward-looking statements regarding topline readouts for Phase 3 ONWARD and Phase 2b LUMUS, envudeucitinib potential, lonigutamab evaluation, cash runway, and upcoming conference participation[13](index=13&type=chunk) - Actual results may differ materially from forward-looking statements due to risks and uncertainties related to regulatory approval, clinical trial outcomes, funding, intellectual property, and other SEC filing risks[13](index=13&type=chunk) [Condensed Consolidated Financial Statements](index=6&type=section&id=Condensed%20Consolidated%20Financial%20Statements) This section presents Alumis' condensed consolidated statements of operations and balance sheets for Q2 2025 and prior periods [Condensed Consolidated Statements of Operations and Comprehensive Loss](index=6&type=section&id=CONDENSED%20CONSOLIDATED%20STATEMENTS%20OF%20OPERATIONS%20AND%20COMPREHENSIVE%20LOSS) The statements show a **$59.3 million net income** for Q2 2025, a substantial improvement from a prior-year loss, driven by a **$187.9 million** merger gain and increased expenses | (in thousands) | Three Months Ended June 30, 2025 | Three Months Ended June 30, 2024 | | :------------- | :------------------------------- | :------------------------------- | | Total revenue | $2,666 | $0 | | Research and development expenses | $108,755 | $48,565 | | General and administrative expenses | $34,450 | $7,575 | | Total operating expenses | $143,205 | $56,140 | | Loss from operations | $(140,539) | $(56,140) | | Gain on bargain purchase | $187,907 | $0 | | Interest income | $3,430 | $1,977 | | Net income (loss) before income taxes | $50,760 | $(56,508) | | Income tax benefit | $8,561 | $0 | | Net income (loss) | $59,321 | $(56,508) | [Condensed Consolidated Balance Sheets](index=7&type=section&id=CONDENSED%20CONSOLIDATED%20BALANCE%20SHEETS) As of June 30, 2025, total assets reached **$610.9 million**, up from **$341.0 million** at year-end 2024, driven by increased marketable securities and intangible assets from the ACELYRIN merger | (in thousands) | June 30, 2025 | December 31, 2024 | | :------------- | :------------ | :---------------- | | Cash and cash equivalents | $151,753 | $169,526 | | Restricted cash | $367 | $0 | | Marketable securities | $334,568 | $118,737 | | Total current assets | $517,558 | $306,188 | | Intangible assets | $50,959 | $0 | | Total assets | $610,925 | $340,992 | | Total current liabilities | $85,575 | $50,910 | | Total liabilities | $125,598 | $80,888 | | Total stockholders' equity | $485,327 | $260,104 | [Alumis Contact Information](index=7&type=section&id=Alumis%20Contact%20Information) This section provides contact details for Alumis' media relations [Alumis Contact Information](index=7&type=section&id=Alumis%20Contact%20Information_detail) This section provides media contact details for Alumis, specifically Teri Dahlman of Red House Communications - Contact for Alumis media relations is Teri Dahlman at Red House Communications (teri@redhousecomms.com)[17](index=17&type=chunk)