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].

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].