– Late-breaking oral presentation to highlight 52-week data of ESK-001 in a Phase 2 open-label extension (OLE) study in adults with moderate-to-severe plaque psoriasis – – Additional Phase 2 e-poster presentations to describe patient-reported outcomes, disease biomarker activity and pharmacokinetic data of ESK-001 in psoriasis patients – – Phase 3 ONWARD program topline data now expected in Q1 2026 – SOUTH SAN FRANCISCO, Calif., Feb. 28, 2025 (GLOBE NEWSWIRE) -- Alumis Inc. (Nasdaq: ALMS) (“Alumis” or the “ ...

Core Insights - Alumis Inc. is a clinical stage biopharmaceutical company focused on developing oral therapies for immune-mediated diseases, with a precision approach to optimize clinical outcomes [5][6] - The company announced two data presentations for its drug A-005, a selective TYK2 inhibitor, at the ACTRIMS Forum 2025 [1][2] Group 1: A-005 Drug Development - A-005 is a potent, selective, CNS-penetrant TYK2 inhibitor aimed at treating neuroinflammatory diseases, including multiple sclerosis and Parkinson's Disease [4] - The Phase 1 clinical trial of A-005 involved 135 healthy participants and demonstrated safety, tolerability, and pharmacokinetics, with plans for a Phase 2 trial in multiple sclerosis patients in the second half of 2025 [3][4] - A-005 is the first reported allosteric TYK2 inhibitor capable of crossing the blood-brain barrier, targeting pro-inflammatory cytokine pathways [2][4] Group 2: Upcoming Presentations - The presentations on A-005 will take place on February 28, 2025, with specific titles and times for each poster session [2] - The first presentation will focus on A-005's modulation of astrocytes and microglia, while the second will cover its safety, tolerability, and pharmacokinetics in healthy volunteers [2] Group 3: Company Overview - Alumis is leveraging a proprietary precision data analytics platform to build a pipeline of molecules for various immune-mediated diseases [5][6] - The company's most advanced product candidate, ESK-001, is being evaluated for moderate-to-severe plaque psoriasis and systemic lupus erythematosus [5]

SOUTH SAN FRANCISCO, Calif., Feb. 10, 2025 (GLOBE NEWSWIRE) -- Alumis Inc. (Nasdaq: ALMS), a clinical-stage biopharmaceutical company developing oral therapies using a precision approach to optimize clinical outcomes and significantly improve the lives of patients with immune-mediated diseases, today announced that Martin Babler, President and Chief Executive Officer of Alumis, will present at the virtual Oppenheimer 35th Annual Healthcare Life Sciences Conference on Tuesday, February 11, 2025 at 3:20 pm ET ...

Core Insights - Alumis Inc. announced positive results from a Phase 1 clinical trial for A-005, a TYK2 inhibitor, which showed good tolerability and the ability to cross the blood-brain barrier [1][2] - The company plans to initiate a Phase 2 clinical trial for A-005 in multiple sclerosis (MS) in the second half of 2025 [1][2] Group 1: Clinical Trial Results - A-005 was well tolerated in a Phase 1 trial involving 135 healthy participants, with no serious adverse events reported [2][4] - The drug demonstrated significant and prolonged exposure in the cerebral spinal fluid (CSF), with levels comparable to or exceeding those in plasma [2] - A pharmacokinetic/pharmacodynamic (PK/PD) relationship was established, showing prolonged TYK2 inhibition in the periphery [2][4] Group 2: Future Plans and Indications - The Phase 2 clinical trial for A-005 in MS is anticipated to start in the second half of 2025 [2][3] - The company aims to demonstrate clinical benefits of A-005 in MS and potentially in other neuroinflammatory and neurodegenerative conditions [2][5] Group 3: Product and Company Overview - A-005 is a first-in-class CNS penetrant allosteric TYK2 inhibitor targeting neuroinflammatory diseases like MS and Parkinson's Disease [5][7] - Alumis is focused on developing oral therapies for immune-mediated diseases, leveraging a precision data analytics platform to optimize clinical outcomes [6][7]

Financial Performance - The company reported a net loss of $93.1 million for the three months ended September 30, 2024, compared to a net loss of $43.4 million for the same period in 2023, representing a 114% increase in losses year-over-year[132]. - For the nine months ended September 30, 2024, the net loss was $199.5 million, up from $115.7 million in the same period of 2023, indicating a 72% increase in losses[132]. - As of September 30, 2024, the company had an accumulated deficit of $563.8 million, primarily due to research and development expenses[132]. - Net loss for the three months ended September 30, 2024, was $93.1 million, representing a 115% increase from a net loss of $43.4 million in the prior year[155]. - Net cash used in operating activities was $180.3 million for the nine months ended September 30, 2024, compared to $96.2 million for the same period in 2023[192]. Revenue Generation - The company has not generated any revenue from product sales since its inception and does not expect to do so until regulatory approval is obtained for its product candidates[134]. - The company has not generated any revenue from product sales since inception and does not expect to do so until obtaining regulatory approval for its product candidates[187]. Expenses - Research and development expenses increased by 132% to $87.8 million for the three months ended September 30, 2024, compared to $37.8 million for the same period in 2023[155]. - General and administrative expenses rose by 77% to $10.6 million for the three months ended September 30, 2024, from $6.0 million in the prior year[155]. - Total operating expenses for the three months ended September 30, 2024, were $98.4 million, a 125% increase from $43.8 million in the same period of 2023[155]. - Research and development expenses for the nine months ended September 30, 2024, increased by 73% to $178.4 million from $103.1 million in the same period of 2023[156]. - CRO, CMO, and clinical trials expenses increased by $21.4 million for the three months ended September 30, 2024, primarily due to the timing and progression of clinical trials[162]. - Personnel-related costs increased by $5.0 million for the three months ended September 30, 2024, primarily due to increased headcount and stock-based compensation[163]. - Total external research and development expenses for the three months ended September 30, 2024, were $69.9 million, up from $24.9 million in the same period of 2023[170]. - General and administrative expenses increased by $4.6 million, reaching $10.6 million for the three months ended September 30, 2024, compared to $6.0 million for the same period in 2023[171]. - Personnel-related expenses rose by $3.5 million to $6.4 million for the three months ended September 30, 2024, primarily due to increased headcount and stock-based compensation[172]. Financing Activities - The company raised $233.3 million in net proceeds from its initial public offering (IPO) and a concurrent private placement, completed in July 2024[130]. - Net cash provided by financing activities was $492.4 million for the nine months ended September 30, 2024, including $193.3 million from the IPO[197]. - The company plans to monitor expenses and may raise additional capital through public and private equity, debt financings, and strategic alliances[184]. Clinical Development - The ongoing Phase 3 ONWARD clinical program for ESK-001 is expected to report topline results in the first half of 2026[127]. - The Phase 1 program for A-005 was initiated in April 2024, with initial results expected by the end of 2024[127]. - The company incurred a milestone payment of $23.0 million in August 2024 related to the first administration of ESK-001 in a Phase 3 clinical trial[185]. - A milestone payment of $37.0 million was incurred during the year ended December 31, 2022, and a subsequent payment of $23.0 million was made in August 2024 related to the first administration of ESK-001 in a Phase 3 clinical trial[201]. Cash and Liquidity - The company had cash, cash equivalents, and marketable securities of $361.9 million as of September 30, 2024, expected to meet operating and capital requirements for at least 12 months[184]. - The company is classified as an "emerging growth company" under the JOBS Act, allowing it to delay the adoption of certain accounting standards[206]. Economic and Market Conditions - Macroeconomic conditions, including rising inflation and geopolitical tensions, may impact the company's ability to obtain financing and could affect its business operations[141]. - The company does not believe that a hypothetical 10% increase or decrease in interest rates would have a material effect on its financial statements[211]. - Foreign currency transaction gains and losses have not been material to the company's consolidated financial statements, and it does not have a formal hedging program[212]. - The company has not experienced a material effect from inflation on its business or financial condition[213]. Internal Controls - There were no changes in the company's internal control over financial reporting during the quarter ended September 30, 2024, that materially affected its internal control[216].

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].