– Presented Phase 2 STRIDE OLE 52-week psoriasis data at AAD 2025 demonstrating next-generation oral TYK2 inhibitor ESK-001 treatment led to robust long-term clinical responses and was well tolerated; Phase 3 ONWARD program data readout now expected 1Q 2026 – – Presented Phase 1 clinical data at ACTRIMS 2025 demonstrating first-in-class oral TYK2 inhibitor A-005 has ability to cross blood-brain barrier and was well tolerated; Phase 2 in MS to begin 2H 2025 – – Announced merger agreement with ACELYRIN to cre ...

SOUTH SAN FRANCISCO, Calif., March 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 participate in a fireside chat at Leerink's 2025 Global Healthcare Conference on Tuesday, March 11, 2025 at 10:40 am ET. A li ...

ESK-001 is a highly selective, next-generation oral tyrosine kinase 2 (TYK2) inhibitor currently under development in moderate-to-severe plaque psoriasis and systemic lupusPhase 2 OLE data of ESK-001 at 40 mg BID demonstrated sustained or increasing clinical responses through week 52 on PASI 90, PASI 100, and sPGA 0ESK-001 was generally well-tolerated at one year, with no new safety findingsData further support ESK-001's potential to offer a highly differentiated and best-in-class treatment option for peopl ...

Combined company to benefit from differentiated late-stage portfolio of therapies and strong balance sheetSOUTH SAN FRANCISCO, Calif. and LOS ANGELES, March 04, 2025 (GLOBE NEWSWIRE) -- Alumis Inc. (Nasdaq: ALMS) (“Alumis”) and ACELYRIN, INC. (Nasdaq: SLRN) (“ACELYRIN”) today reaffirmed their commitment to merge in an all-stock transaction, which will create a leading clinical stage biopharma company in immune-mediated diseases. Martin Babler, President, Chief Executive Officer and Chairman of Alumis, said, ...

– 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]

Core Insights - Alumis Inc. is a clinical-stage biopharmaceutical company focused on developing oral therapies for immune-mediated diseases using a precision approach to enhance clinical outcomes and patient quality of life [3] Company Overview - Alumis is leveraging a proprietary precision data analytics platform to build a pipeline of molecules aimed at treating a variety of immune-mediated diseases, either as monotherapy or in combination therapies [3] - The company's lead product candidate, ESK-001, is an oral, highly selective small molecule that acts as an allosteric inhibitor of tyrosine kinase 2 (TYK2), currently under evaluation for moderate-to-severe plaque psoriasis and systemic lupus erythematosus [3] - Additionally, Alumis is developing A-005, a CNS-penetrant allosteric TYK2 inhibitor targeting neuroinflammatory and neurodegenerative diseases [3] - The company is incubated by Foresite Labs and is led by a team experienced in small-molecule drug development for immune-mediated diseases, aiming to pioneer a precision approach to drug development [3]

Alumis (ALMS) M&A Announcement February 06, 2025 05:00 PM ET Company Participants Martin Babler - Chairman, CEO & PresidentMina Kim - CEOJohn Schroer - CFOKatherine Wang - Equity Associate Conference Call Participants Eric Schmidt - Biotechnology AnalystThomas Smith - Senior Research AnalystTerence Flynn - Equity Research AnalystYasmeen Rahimi - Sr. Research AnalystYatin Suneja - Biotechnology Research AnalystBrian Skorney - Senior Research AnalystNone - Analyst Operator Hello, and welcome to today's call t ...

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].