Financial Position - As of September 30, 2024, Alumis had cash and cash equivalents and marketable securities of $361.9 million, expected to fund operations into 2026[9] - Total current assets increased significantly to $377,347,000 in 2024 from $53,357,000 in 2023, representing a growth of 608%[16] - Cash and cash equivalents rose to $213,417,000 in 2024, up from $45,996,000 in 2023, marking an increase of 364%[16] - Total assets reached $412,559,000 in 2024, compared to $89,612,000 in 2023, reflecting a growth of 360%[16] - Total current liabilities increased to $33,515,000 in 2024 from $20,871,000 in 2023, which is an increase of 60%[16] - Stockholders' equity improved to $348,389,000 in 2024, up from a deficit of $339,260,000 in 2023, indicating a positive shift in equity[16] - Total liabilities increased to $64,170,000 in 2024 from $53,502,000 in 2023, which is an increase of 20%[16] Research and Development - Research and development expenses for Q3 2024 were $87.8 million, a significant increase from $37.8 million in Q3 2023, driven by a $23.0 million clinical milestone payment and increased trial costs[10] - A-005 Phase 1 clinical study data is expected by year-end 2024, with plans to initiate a Phase 2 trial in multiple sclerosis in 2025[8] - ESK-001 demonstrated a primary endpoint achievement of PASI 75 in 93% of patients at the top dose of 40 mg twice daily in the Phase 2 study[3] - The Phase 3 ONWARD program for ESK-001 in moderate-to-severe plaque psoriasis includes two parallel 24-week trials, with topline results anticipated in the first half of 2026[5] - The 40 mg twice daily dose of ESK-001 achieved maximal target inhibition, leading to the highest response rates and significant improvements in patients' quality of life[4] - Research and development accrued expenses rose to $18,140,000 in 2024, compared to $10,946,000 in 2023, an increase of 66%[16] Operating Expenses - General and administrative expenses for Q3 2024 were $10.6 million, up from $6.0 million in Q3 2023, primarily due to personnel-related expenses[11] - Total operating expenses for Q3 2024 were $98.4 million, compared to $43.8 million for the same period in 2023[15] Net Loss and Income - Net loss for Q3 2024 was $93.1 million, compared to a net loss of $43.4 million for the same period in 2023[12] - Interest income for Q3 2024 was $5.3 million, compared to $951,000 in Q3 2023, reflecting increased cash reserves[15] Accounts and Capital - Accounts payable increased to $6,444,000 in 2024 from $1,118,000 in 2023, representing a growth of 478%[16] - Additional paid-in-capital surged to $912,037,000 in 2024, up from $25,055,000 in 2023, a remarkable increase of 3541%[16] - The accumulated deficit widened to $(563,792,000) in 2024 from $(364,318,000) in 2023, indicating a deeper financial loss[16]

Core Insights - Alumis Inc. is advancing its clinical programs, particularly focusing on ESK-001 and A-005, which target immune-mediated diseases through maximal TYK2 inhibition [1][2][4] Clinical Programs - The company is conducting three clinical programs: a global Phase 3 ONWARD trial for ESK-001 in moderate-to-severe plaque psoriasis, a Phase 2b trial for ESK-001 in systemic lupus erythematosus (SLE), and a Phase 1 study for A-005 aimed at neuroinflammatory and neurodegenerative diseases [1][4][5] - ESK-001 has shown promising results in a Phase 2 study, with 93% of patients achieving the primary endpoint of PASI 75 at the highest dose of 40 mg twice daily [4] - A-005 is designed to be a first-in-class CNS inhibitor, with Phase 1 data expected by the end of 2024 [2][5] Financial Performance - As of September 30, 2024, Alumis reported cash and cash equivalents of $361.9 million, sufficient to fund operations into 2026 [5] - Research and development expenses increased to $87.8 million for Q3 2024, up from $37.8 million in Q3 2023, primarily due to clinical milestone payments and increased trial costs [5][10] - The net loss for Q3 2024 was $93.1 million, compared to $43.4 million for the same period in 2023 [5][10] Upcoming Milestones - Key upcoming milestones include the expected Phase 1 data for A-005 by year-end 2024 and the 52-week Phase 2 OLE study data for ESK-001 anticipated in Q1 2025 [2][5] - Topline results for the Phase 3 ONWARD program in psoriasis are expected in the first half of 2026, along with topline data for the SLE Phase 2b trial [5][6] Company Overview - Alumis is a clinical-stage biopharmaceutical company focused on developing oral therapies for immune-mediated diseases using a precision approach [7] - The company's lead product candidate, ESK-001, is a selective TYK2 inhibitor, while A-005 is being developed for neuroinflammatory and neurodegenerative conditions [7]

Financial Performance - The company reported a net loss of $56.5 million for Q2 2024, compared to a net loss of $36.3 million in Q2 2023, reflecting an increase of 55% year-over-year [147]. - For the first half of 2024, the net loss was $106.4 million, up from $72.3 million in the same period of 2023, indicating a 47% increase [147]. - Net loss for the three months ended June 30, 2024, was $56.5 million, compared to a net loss of $36.3 million for the same period in 2023, reflecting a 56% increase in losses [171]. - Total operating expenses for the three months ended June 30, 2024, were $56.1 million, up from $37.6 million in the same period of 2023, marking a 49% increase [171]. - Net cash used in operating activities was $96.5 million for the six months ended June 30, 2024, compared to $63.0 million for the same period in 2023 [200]. Research and Development - The company has initiated multiple Phase 3 clinical trials for ESK-001 in moderate-to-severe plaque psoriasis, with patient dosing commencing in July 2024 [142]. - A Phase 1 program for A-005, a CNS-penetrant TYK2 inhibitor, was initiated in April 2024, with initial results expected by the end of 2024 [142]. - Research and development expenses increased by $15.7 million, reaching $48.6 million for the three months ended June 30, 2024, compared to $32.8 million for the same period in 2023, representing a 48% increase [171]. - Research and development expenses for the six months ended June 30, 2024, totaled $90.5 million, an increase of $25.2 million from $65.3 million in the same period of 2023, a 39% increase [174]. - Personnel-related costs in research and development increased by $2.3 million for the three months ended June 30, 2024, primarily due to increased headcount and stock-based compensation [176]. Funding and Capital Structure - The company closed its IPO on July 1, 2024, raising approximately $193.2 million in net proceeds after offering costs [152]. - In addition to the IPO, a Concurrent Private Placement raised an additional $40.0 million from an existing investor [153]. - As of June 30, 2024, the company had cash, cash equivalents, and marketable securities totaling $209.5 million, with expected net proceeds of approximately $233.2 million from its IPO and Concurrent Private Placement to fund operations for at least the next 12 months [193]. - Net cash provided by financing activities for the six months ended June 30, 2024, was $257.2 million, primarily from the issuance of Series C redeemable convertible preferred stock [205]. - The company has not generated any revenue from product sales since inception and anticipates needing substantial additional funding for ongoing operations [191]. Expenses and Liabilities - General and administrative expenses rose by $2.8 million to $7.6 million for the three months ended June 30, 2024, up from $4.8 million in the same period of 2023, a 59% increase [181]. - General and administrative expenses for the six months ended June 30, 2024, increased by $4.2 million to $13.2 million from $9.0 million in the same period of 2023 [183]. - The company recognized a derivative liability loss of $2.3 million and $5.4 million for the three and six months ended June 30, 2024, respectively, related to Series C financing [189]. - The company incurred a milestone payment of $23.0 million in July 2024 related to the first administration of ESK-001 in a Phase 3 clinical trial, expected to be paid in Q3 2024 [194]. - As of June 30, 2024, the company had total lease payment obligations under non-cancelable leases of $31.6 million, including $2.6 million payable through December 31, 2024 [209]. Market and Economic Conditions - Inflation has increased costs related to labor and research and development, but the company does not believe it has had a material effect on its financial condition [219]. - The company is exposed to interest rate risks related to cash equivalents and marketable securities, but does not expect a 10% change in interest rates to materially affect its financial statements [215]. - The company has not had a formal hedging program for foreign currency exchange risks, and does not believe that fluctuations in exchange rates would materially impact its financial statements [216][217]. Company Classification - The company is classified as an "emerging growth company" under the JOBS Act, allowing it to delay the adoption of certain accounting standards [212]. - The company is also a "smaller reporting company," with a market value of common stock held by non-affiliates less than $700.0 million and annual revenue below $100.0 million [214].

Clinical Development - Alumis initiated patient dosing in the ONWARD Phase 3 clinical program for ESK-001 in moderate-to-severe plaque psoriasis, consisting of two identical 24-week global trials[3]. - The anticipated topline results for the ESK-001 Phase 3 program are expected in 2026[3]. - A-005 Phase 1 clinical trial data in healthy participants is expected by year-end 2024, with a Phase 2 trial in multiple sclerosis planned for 2025[4]. Financial Performance - The company raised $250 million in gross proceeds from its IPO and private placement, issuing 15,625,000 shares at $16.00 per share[3]. - The net loss for Q2 2024 was $56.5 million, compared to a net loss of $36.3 million in Q2 2023[5]. - The company reported total operating expenses of $56.1 million for Q2 2024, compared to $37.6 million for the same period in 2023[10]. Expenses - Research and development expenses increased to $48.6 million for Q2 2024, up from $32.8 million in Q2 2023, primarily due to higher clinical costs for ESK-001[5]. - General and administrative expenses rose to $7.6 million in Q2 2024, compared to $4.8 million in Q2 2023, reflecting the expansion of administrative functions[5]. Assets and Liabilities - As of June 30, 2024, Alumis had cash and cash equivalents of $155.1 million, with total current assets amounting to $224.9 million[11]. - Alumis' total liabilities increased to $265.2 million as of June 30, 2024, compared to $89.6 million at the end of 2023[11].