[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 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)

Core Insights - Alumis Inc. has completed patient enrollment in pivotal clinical trials for its investigational therapy envudeucitinib, with topline data expected in early Q1 2026 for plaque psoriasis and Q3 2026 for systemic lupus erythematosus [1][2][5] - The company has successfully merged with ACELYRIN, Inc., enhancing its financial position and supporting the advancement of its late-stage immunology pipeline [1][2][7] - As of June 30, 2025, Alumis reported cash, cash equivalents, and marketable securities totaling $486.3 million, which is expected to fund operations into 2027 [1][10] Clinical Development - The Phase 3 ONWARD program for envudeucitinib includes two parallel global trials designed to evaluate its efficacy and safety in adult patients with moderate-to-severe plaque psoriasis, with topline data expected in early Q1 2026 [5][8] - The Phase 2b LUMUS trial for systemic lupus erythematosus has enrolled 408 patients, with topline data anticipated in Q3 2026 [5][8] Financial Performance - For the quarter ended June 30, 2025, Alumis reported total revenue of $2.7 million, primarily from collaboration revenue, compared to no revenue in the same quarter of 2024 [7][15] - Research and development expenses increased to $108.8 million for Q2 2025, up from $48.6 million in Q2 2024, driven by clinical trial costs and merger-related expenses [7][15] - The company recorded a net income of $59.3 million for Q2 2025, including a non-operating gain of $187.9 million from the merger with ACELYRIN, compared to a net loss of $56.5 million in Q2 2024 [7][15] Corporate Developments - The merger with ACELYRIN has strengthened Alumis' balance sheet, allowing for the advancement of its late-stage pipeline through multiple planned key data readouts [6][9] - The company has appointed Sanam Pangali as Chief Legal Officer and Corporate Secretary, bringing nearly two decades of legal expertise [6][8] Pipeline Updates - Alumis is advancing A-005, a fully CNS-penetrant TYK2 inhibitor, towards Phase 2 clinical trials for multiple sclerosis, expected to initiate in the first half of 2026 [8] - The company is also developing lonigutamab, a next-generation therapy for thyroid eye disease, which has received Fast Track Designation from the FDA [8][11]

Core Insights - Alumis Inc. has completed patient enrollment in its global LUMUS Phase 2b trial for ESK-001, a next-generation oral TYK2 inhibitor targeting systemic lupus erythematosus (SLE), with topline data expected in Q3 2026 [1][5]. Company Overview - Alumis is a late-stage biopharma company focused on developing targeted therapies for immune-mediated diseases, leveraging a proprietary data analytics platform [7]. - The company is developing a pipeline of oral TYK2 inhibitors, including ESK-001 for SLE and moderate-to-severe plaque psoriasis, and A-005 for neuroinflammatory and neurodegenerative diseases [7]. Clinical Trial Details - The LUMUS Phase 2b trial is a randomized, double-blind, placebo-controlled study involving 408 patients with moderately-to-severely active, autoantibody-positive SLE, assessing the efficacy of ESK-001 over 48 weeks [2][5]. - The primary endpoint of the trial is to evaluate improvements in overall disease activity using the British Isles Lupus Assessment Group-based Composite Lupus Assessment (BICLA) at Week 48 [2][5]. Drug Mechanism and Efficacy - ESK-001 is designed to selectively target key inflammatory drivers, such as type 1 interferon (IFN), aiming for maximal inhibition while minimizing off-target effects [3][4]. - Clinical data from the psoriasis program indicates that ESK-001 downregulates key cytokines and disease biomarkers, suggesting potential to reduce SLE disease activity [4]. Future Prospects - The company anticipates that ESK-001 could provide biologic-like clinical responses for SLE, based on its performance in previous clinical studies [4].

Core Insights - Alumis Inc. has completed patient enrollment in its global LUMUS Phase 2b trial for ESK-001, a next-generation oral TYK2 inhibitor aimed at treating systemic lupus erythematosus (SLE) [2][3] - The trial enrolled 408 patients and topline data is expected in Q3 2026, marking a significant milestone for both the company and the lupus community [3][6] - ESK-001 is designed to selectively target key inflammatory drivers, potentially offering a new treatment option for patients with SLE who currently have limited choices [3][4] Company Overview - Alumis is a late-stage biopharma company focused on developing targeted therapies for immune-mediated diseases, leveraging a proprietary data analytics platform [8] - The company's pipeline includes ESK-001 for SLE and moderate-to-severe plaque psoriasis, as well as A-005 for neuroinflammatory and neurodegenerative diseases [8] - Alumis aims to improve patient health outcomes through its innovative therapies and precision approach [8] Clinical Trial Details - The LUMUS Phase 2b trial is a randomized, double-blind, placebo-controlled study evaluating multiple doses of ESK-001 over 48 weeks [6] - The primary endpoint is to assess improvements in overall disease activity using the British Isles Lupus Assessment Group-based Composite Lupus Assessment (BICLA) at Week 48 [3][6] - Following the trial, eligible patients may participate in an open-label extension or a four-week safety follow-up [3] ESK-001 Mechanism and Previous Data - ESK-001 is a highly selective TYK2 inhibitor that targets proinflammatory mediators, aiming for maximal inhibition with minimal off-target effects [4][5] - Clinical data from Alumis' psoriasis program indicates that ESK-001 effectively downregulates key cytokines and disease biomarkers, suggesting potential efficacy in reducing SLE disease activity [5] - Phase 1 studies showed that ESK-001 achieved full, sustained target inhibition and was well tolerated in healthy volunteers [5]

Core Insights - Alumis Inc. has promoted Sanam Pangali to Chief Legal Officer and Corporate Secretary, succeeding Sara Klein who has retired [1][2] - Sanam Pangali has a strong background in legal and business roles, previously serving as Senior Vice President, Legal at Alumis and holding leadership positions at ACELYRIN, Inc. and other biopharmaceutical companies [2] - Alumis is focused on developing next-generation targeted therapies for immune-mediated diseases, with a pipeline that includes oral tyrosine kinase 2 inhibitors and anti-insulin-like growth factor 1 receptor therapy [3] Company Overview - Alumis is a late-stage biopharma company dedicated to improving patient health outcomes in immune-mediated diseases [3] - The company utilizes a proprietary data analytics platform to develop its therapies, which include ESK-001 for systemic immune-mediated disorders and A-005 for neuroinflammatory diseases [3] - The pipeline also features lonigutamab for thyroid eye disease and several preclinical programs identified through a precision approach [3]

Summary of Illumis (ALMS) Conference Call Company Overview - Illumis recently completed a merger with Accelerin to strengthen its position as a leading immunology company [2][3] - The merger aims to combine their pipelines and financial resources to build a well-capitalized precision immunology company [3] Key Pipeline Developments - Upcoming key readouts include: - Psoriasis readout expected in early 2026 after completing enrollment of over 1,700 patients in a Phase III trial [4][7] - Lupus readout planned for next year, with ongoing Phase II trial expected to complete enrollment by summer [5][8] - The company has a cash runway into 2027, with approximately $600 million in cash and 100 million shares outstanding [6] Psoriasis Program - The psoriasis program is in Phase III, with a six-month readout expected early in 2026 [4][7] - The trial has been completed ahead of schedule, indicating strong patient interest [7] - The company is focused on maximizing target inhibition with its TYK2 inhibitors, which have shown promising results in clinical trials [12][21] Lupus Program - The lupus program is designed as a pivotal trial to demonstrate significant efficacy over placebo [43] - The company aims to reduce the placebo effect by ensuring strict patient selection and monitoring [44] - The ongoing study is expected to read out in 2026, with a focus on genetic validation for TYK2 inhibition in lupus patients [38][40] Competitive Landscape - The psoriasis market is competitive, but injectable biologics account for less than 10% of treatments, indicating a significant opportunity for effective oral therapies [34][35] - The company aims to capture a portion of the market by offering a highly efficacious and safe oral drug [34] Differentiation and Safety Profile - Illumis emphasizes the importance of maximum target inhibition for efficacy and safety, with ongoing studies supporting this hypothesis [20][21] - The safety profile of their drugs has been favorable, with no significant safety findings reported to date [24][25] Future Milestones - The company plans to initiate a Phase II trial for its brain-penetrant TYK2 inhibitor, A5, later this year [52][56] - A once-a-day formulation for ESK001 is also in development, with plans to announce details later this year [57] - Key readouts for psoriasis and lupus are anticipated in 2026, along with potential updates on MS and lanagutamab [58] External Validation - A partnership with Kakken in Japan for the development of ESK001 has provided external validation and a significant financial boost [46] Conclusion - Illumis is strategically positioned in the immunology space with a robust pipeline and a focus on maximizing efficacy and safety through innovative drug development and strategic partnerships [2][3][34]

Company Overview - Alumis Inc. is a late-stage biopharma company focused on developing next-generation targeted therapies for immune-mediated diseases [3] - The company utilizes a proprietary data analytics platform and precision approach to enhance patient health and outcomes [3] Pipeline Development - Alumis is developing a pipeline of oral tyrosine kinase 2 inhibitors, including ESK-001 for systemic immune-mediated disorders like moderate-to-severe plaque psoriasis and systemic lupus erythematosus [3] - A-005 is being developed for neuroinflammatory and neurodegenerative diseases [3] - The pipeline also features lonigutamab, an anti-insulin-like growth factor 1 receptor therapy for thyroid eye disease, along with several preclinical programs [3] Upcoming Events - Martin Babler, President and CEO of Alumis, will present at the Jefferies Global Healthcare Conference on June 4, 2025, at 3:10 p.m. ET [1] - A live webcast of the presentation will be available on the Alumis website, with a replay archived for 90 days [2]

Core Insights - Alumis Inc. has completed patient enrollment in its pivotal Phase 3 ONWARD clinical program for ESK-001, targeting moderate-to-severe plaque psoriasis, with over 1,700 patients enrolled [2][4] - Topline results are expected to be reported in early Q1 2026, indicating progress towards providing new treatment options for patients [1][2] - ESK-001 is a next-generation oral TYK2 inhibitor designed to address immune dysregulation in various diseases, including plaque psoriasis [3][7] Clinical Program Details - The ONWARD clinical program consists of two parallel global Phase 3 trials, ONWARD1 and ONWARD2, each lasting 24 weeks and designed to evaluate the efficacy and safety of ESK-001 [4][5] - Patients are randomized in a 2:1:1 ratio to receive either ESK-001 40 mg twice daily, placebo, or apremilast, with co-primary endpoints focusing on the Psoriasis Area and Severity Index (PASI 75) and sPGA score [4][5] - An optional long-term extension trial, ONWARD3, is ongoing to assess the durability and long-term safety of ESK-001 for patients completing Week 24 [5] Product Profile - ESK-001 is characterized as a highly selective oral TYK2 inhibitor, aiming to minimize off-target effects while providing effective treatment for immune-mediated diseases [3][7] - The drug's development is supported by positive data from the Phase 2 STRIDE clinical trial and ongoing long-term open-label extensions [5] Broader Development Pipeline - Alumis is also exploring ESK-001's potential in other immune-mediated conditions, including a Phase 2b trial for systemic lupus erythematosus [6][7] - The company is developing a once-daily modified-release formulation of ESK-001 to enhance patient convenience compared to the current twice-daily regimen [5]

Company Overview - Alumis Inc. has completed its merger with ACELYRIN, Inc., establishing itself as a leading clinical-stage biopharma company with a differentiated portfolio of therapies and a strong balance sheet [1][3] - Each ACELYRIN stockholder will receive 0.4814 shares of Alumis common stock for each share of ACELYRIN common stock owned, with ACELYRIN common stock ceasing to trade on NASDAQ [2] Financial Position - The merger significantly strengthens Alumis' balance sheet, allowing for the advancement of its late-stage portfolio and the development of transformative therapies for patients [3] - Alumis now has a cash runway that extends into 2027, supporting multiple planned key data readouts [3] Product Pipeline - Alumis is developing next-generation targeted therapies for immune-mediated diseases, including oral tyrosine kinase 2 inhibitors such as ESK-001 for systemic immune-mediated disorders and A-005 for neuroinflammatory diseases [5] - The pipeline also includes lonigutamab, an anti–insulin-like growth factor 1 receptor therapy for thyroid eye disease, along with several preclinical programs identified through a precision approach [5] Advisory Team - Morgan Stanley & Co. LLC served as the financial advisor to Alumis, while Cooley LLP acted as its legal counsel [4] - Guggenheim Securities, LLC served as the financial advisor to ACELYRIN, with Fenwick & West LLP and Paul Hastings LLP providing legal counsel [4]