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Alumis Inc.(ALMS) - 2024 Q4 - Annual Results
2025-03-19 20:12
Merger Agreement Details - The merger agreement is dated February 6, 2025, between Alumis Inc., Arrow Merger Sub, Inc., and ACELYRIN, Inc.[7] - The merger will result in the cancellation of each outstanding share of common stock of ACELYRIN, with shareholders entitled to receive the merger consideration[9] - The merger is intended to qualify as a "reorganization" for U.S. federal income tax purposes under Section 368(a) of the Code[10] - The closing of the merger will occur on the third business day after the last conditions are satisfied or waived[13] - The effective time of the merger will be when the Certificate of Merger is filed with the Secretary of State of Delaware[15] - The certificate of incorporation of ACELYRIN will be amended and restated to become the certificate of incorporation of the surviving corporation[16] - The bylaws of ACELYRIN will be amended to conform to the bylaws of Arrow Merger Sub[17] - The directors of Arrow Merger Sub will become the directors of the surviving corporation after the merger[18] - The officers of Arrow Merger Sub will serve as the officers of the surviving corporation post-merger[19] - The merger is deemed advisable and in the best interests of both companies and their stockholders as per the resolutions adopted by their respective boards[9] Share Conversion and Options - Each share of the Company will be converted into the right to receive 0.4274 shares of Parent Common Stock as part of the Merger Consideration[21] - All shares, except Excluded Shares, will cease to exist and will be cancelled without payment of any consideration[22] - Each Company Option with an exercise price of $18.00 or less will be converted into an option award to purchase shares of Parent Common Stock, while options with an exercise price above $18.00 will be cancelled without payment[36] - Each unvested Company RSU will be converted into a restricted stock unit award with respect to shares of Parent Common Stock, maintaining the same terms and conditions[37] Exchange and Claims - The Exchange Agent will handle the exchange of shares and will issue cash in lieu of fractional shares, with no interest paid on any amounts[26] - Any portion of the Exchange Fund that remains unclaimed for 180 days after the Effective Time will be delivered to Parent[31] - The Merger Consideration will be adjusted to prevent dilution in case of changes in the number of shares or securities prior to the Effective Time[34] - Holders of Uncertificated Shares will not need to deliver a Certificate to receive the Merger Consideration[33] - The Exchange Agent will aggregate fractional shares and sell them in the open market, providing cash to holders instead of issuing fractional shares[29] - Any lost, stolen, or destroyed Certificates can be replaced upon the making of an affidavit and possibly posting a bond[32] Company Financials and Compliance - At the close of business on January 31, 2025, 100,702,249 Shares were issued and outstanding, with no shares of Company Preferred Stock issued[55] - 21,461,518 Shares were reserved for issuance pursuant to the Company Stock Plans, including 13,644,034 Shares for outstanding Company Options, 3,142,891 Shares for outstanding Company RSUs, and 640,746 Shares for outstanding Company PSUs[55] - 1,675,454 Shares were reserved for issuance pursuant to the Company ESPP[55] - The Company will terminate the Company ESPP immediately prior to the Effective Time[42] - Converted Performance RSUs will vest in three equal installments on May 15 of calendar years 2025, 2026, and 2027, subject to the holder remaining in service[39] - Parent will prepare and file a Form S-8 with the SEC to register shares of Parent Common Stock necessary to fulfill obligations under the Company Equity Awards[41] - No appraisal rights shall be available to holders of Shares in connection with the Merger[44] - The Company has filed all required SEC documents since May 9, 2023, ensuring compliance with SOX and the Exchange Act[67] - The consolidated financial statements included in the SEC documents fairly present the Company's financial position and results of operations[68] - The Company maintains a system of internal control over financial reporting to ensure compliance with GAAP[71] Legal and Regulatory Compliance - The Company is in compliance with all applicable laws and permits, with no significant legal proceedings pending[81] - The Company has no outstanding liabilities that would reasonably be expected to have a material adverse effect[80] - The Company is not a party to any unfiled material contracts that are required to be disclosed[82] - The Company has contracts requiring cash payments exceeding $3,000,000 for the fiscal years ending December 31, 2024, and December 31, 2025[83] - The Company is obligated to make capital investments or expenditures exceeding $500,000[83] - The Company has contracts that materially restrict its ability to compete in any business or geographical area[84] - The Company has legal proceedings involving payments exceeding $500,000[85] - The Company has no material breaches or defaults under any Company Material Contracts[88] - All Company Plans are in compliance with applicable laws and have been operated in accordance with their terms[91] - The Company has made all required contributions and payments for each Company Plan[93] Employment and Labor Compliance - The Company has provided a complete list of current employees, including compensation and employment status[102] - All employees are employed on an at-will basis, with no guaranteed continued employment[103] - The Company has been in compliance with all applicable labor and employment laws since January 1, 2022, with no legal proceedings related to labor matters reported[104] - The Company has not engaged in any mass layoffs or employment actions requiring advance notice under the WARN Act in the past 90 days[107] - The Company has not been involved in any collective bargaining agreements with labor unions, and there are no ongoing labor disputes[106] Intellectual Property and Privacy Compliance - The Company owns all material intellectual property rights free of liens, and has valid agreements in place to protect its trade secrets and confidential information[127] - No claims of discrimination or harassment have been made against senior directors or above, and no investigations or settlements have occurred regarding such claims[108] - The Company has maintained compliance with environmental laws and holds all necessary permits and licenses[109] - The Company has not received any written claims alleging infringement of third-party intellectual property rights since January 1, 2022[130] - The Company and its Subsidiaries have complied with all applicable Privacy Laws and Company Privacy Requirements since January 1, 2022, without any material adverse effect[135] - The Company has implemented appropriate measures to protect Personal Information and has not experienced any Security Incidents requiring notification since January 1, 2022[136] - Since January 1, 2022, the Company has not received any communications alleging material violations of applicable Company Privacy Requirements[137] - The Company and its Subsidiaries hold all necessary permits and licenses required to conduct their business, which are in full force and effect[138] - The Company has been in compliance with all Healthcare Laws and has not received any notices of noncompliance from Governmental Entities since January 1, 2022[141] - The Company has not been subject to any investigations or enforcement actions by the FDA or other Governmental Entities regarding material facts or compliance issues[142] - The Company has conducted all studies and trials in accordance with applicable laws and has not received any notices requiring termination or modification of such trials since January 1, 2022[143] - The Company maintains valid insurance policies that are in full force and effect, with no claims pending that have been denied or disputed by insurers[147] - The Company has not engaged in any actions that would violate Anti-Corruption and Anti-Bribery Laws since January 1, 2022[146] Parent Company Financials and Compliance - As of January 31, 2025, 47,222,419 shares of Parent Common Stock were issued and outstanding, with 7,184,908 shares of Parent Non-Voting Common Stock also issued and outstanding[161] - No shares of Parent Preferred Stock were issued and outstanding as of January 31, 2025[161] - 1,194,073 shares of Parent Common Stock were reserved for the 2024 Employee Stock Purchase Plan, and 19,072,671 shares were reserved for Parent Stock Plans, including 9,525,649 shares for outstanding Parent Stock Options[161] - Parent has filed all required SEC documents since July 1, 2024, ensuring compliance with SOX and the Exchange Act[175] - Each consolidated financial statement included in the Parent SEC Documents fairly presented the consolidated financial position of Parent and its subsidiaries[176] - Parent maintains a system of internal control over financial reporting sufficient to provide reasonable assurance regarding the preparation of financial statements in conformity with GAAP[179] - Parent is in compliance with applicable Nasdaq listing and corporate governance rules[180] - The Parent Special Committee has determined that the merger agreement is advisable and in the best interests of Parent and its stockholders[168] - No shares of capital stock or voting securities of Parent were issued or reserved for issuance other than those mentioned above[165] - Parent has no outstanding obligations to repurchase or redeem any shares of capital stock or voting securities[165] - Parent has maintained disclosure controls and procedures since July 1, 2024, ensuring timely and accurate reporting of financial and non-financial information[181] - There have been no material adverse effects on Parent or its subsidiaries since the date of the Parent Balance Sheet[183] - Parent's business has been conducted in the ordinary course consistent with past practices since the date of the Parent Balance Sheet[185] - No legal proceedings have been pending or threatened against Parent or its subsidiaries that would result in material liabilities[186] - Parent has no liabilities or obligations that would reasonably be expected to have a material adverse effect, except as reflected in the consolidated unaudited balance sheet as of September 30, 2024[187] - Parent and its subsidiaries are in compliance with all applicable laws and permits, with no significant legal challenges reported since January 1, 2022[188] - Parent is not a party to any material contracts that have not been filed as required under the Securities Act[190] - Parent has no pending or threatened legal proceedings related to its employee plans or labor matters[199] - Parent has complied with all labor and employment laws since January 1, 2022, with no significant legal proceedings reported[199]
Alumis Reports Year End 2024 Financial Results and Highlights Recent Achievements
Globenewswire· 2025-03-19 20:05
– 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 ...
Alumis to Present at Leerink's 2025 Global Healthcare Conference
Globenewswire· 2025-03-10 12:00
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] Upcoming Events - Martin Babler, President and CEO of Alumis, will participate in a fireside chat at Leerink's 2025 Global Healthcare Conference on March 11, 2025, at 10:40 am ET [1]
Late-Breaking ESK-001 Phase 2 OLE Data Presented at 2025 AAD Annual Meeting Demonstrate Robust Clinical Responses Over 52-Weeks in Psoriasis
Newsfilter· 2025-03-08 14:00
Core Viewpoint - Alumis Inc. announced positive 52-week data from the open-label extension of its Phase 2 STRIDE clinical trial for ESK-001, indicating its potential as an effective oral therapy for moderate-to-severe plaque psoriasis [1][2][3] Group 1: Clinical Trial Results - Patients receiving 40 mg of ESK-001 twice daily showed sustained clinical responses at Week 52, with PASI 90 at 61.3% compared to 52.4% at Week 12, and PASI 100 at 38.8% compared to 26.8% [2] - At Week 52, 81.3% of patients reported improved control of itch (NRS≤4) and 61.3% reported enhanced quality of life (DLQI0/1) [2] - ESK-001 was well tolerated at Week 52, with safety profiles consistent with earlier data and no new safety findings reported [2][6] Group 2: Drug Profile and Mechanism - ESK-001 is a next-generation oral TYK2 inhibitor designed to correct immune dysregulation related to proinflammatory mediators such as IL-23, IL-17, and type 1 interferon [3][4] - The drug's selective targeting aims to maximize inhibition while minimizing off-target effects, positioning it as a potential best-in-class treatment for plaque psoriasis [4][6] Group 3: Ongoing and Future Studies - The Phase 3 ONWARD clinical program is currently underway, consisting of two parallel trials (ONWARD1 and ONWARD2) with approximately 840 patients each, comparing ESK-001 to placebo and apremilast [5][7] - Topline data from the ONWARD studies is expected in the first quarter of 2026, with ongoing patient enrollment for moderate-to-severe psoriasis [4][5] Group 4: Broader Development Strategy - Alumis is also developing a once-daily modified release formulation of ESK-001 and evaluating its application in systemic lupus erythematosus through the LUMUS Phase 2b trial [8] - The company leverages a precision data analytics platform to explore ESK-001's potential in other immune-mediated conditions, aiming to build a diverse pipeline of therapeutic options [9]
Alumis and ACELYRIN Reaffirm Strategic and Financial Rationale of Proposed Merger
Globenewswire· 2025-03-04 14:01
Core Viewpoint - The merger between Alumis Inc. and ACELYRIN, INC. aims to create a leading clinical-stage biopharma company focused on immune-mediated diseases, enhancing long-term value for shareholders through a diversified late-stage portfolio and strong financial position [1][2][5]. Company Overview - Alumis is a clinical-stage biopharmaceutical company developing oral therapies for immune-mediated diseases, utilizing a precision data analytics platform to optimize clinical outcomes [6]. - ACELYRIN focuses on providing transformative medicines and is currently developing lonigutamab for thyroid eye disease [7]. Merger Details - The all-stock transaction is expected to close in the second quarter of 2025, pending stockholder approval and customary closing conditions [3]. - The combined company will have a pro forma cash position of approximately $737 million as of December 31, 2024, allowing for the advancement of its pipeline and operational needs into 2027 [5]. Strategic Benefits - The merger will create a diversified portfolio of late-stage clinical assets targeting large, established markets, including therapies for plaque psoriasis, systemic lupus erythematosus, and multiple sclerosis [5]. - The combined company is expected to leverage increased financial flexibility and resources to develop life-changing medicines and enhance commercial capabilities [5]. Leadership and Governance - The executive leadership teams of both companies have a proven track record in public company management and value creation, positioning the combined entity for success [5]. - The ACELYRIN Board of Directors supports the merger, believing it maximizes long-term value for its stockholders [2]. Financial Advisors - Morgan Stanley & Co. LLC is serving as financial advisor to Alumis, while Guggenheim Securities, LLC is advising ACELYRIN [4].
Alumis Announces Late-Breaker Psoriasis Presentation of 52-week Phase 2 OLE Data for ESK-001 at 2025 American Academy of Dermatology Annual Meeting and Accelerated Topline Phase 3 Data Readout
Globenewswire· 2025-02-28 14:08
– 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 “ ...
Alumis Presents Additional Phase 1 Data at ACTRIMS Forum 2025 Supporting Potential of A-005 as First-in-Class CNS Penetrant TYK2 Inhibitor for Treatment of Neuroinflammatory and Neurodegenerative Diseases
Globenewswire· 2025-02-27 21:15
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]
Alumis to Present at Oppenheimer 35th Annual Healthcare Life Sciences Conference
Globenewswire· 2025-02-10 21:45
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 Transcript
2025-02-06 23:00
Summary of Conference Call on Alumis and Accelerant Merger Industry and Companies Involved - **Industry**: Biotechnology, specifically focusing on immunology and drug development - **Companies**: Alumis and Accelerant Key Points and Arguments 1. **Merger Announcement**: Alumis is merging with Accelerant, creating a differentiated late-stage portfolio with significant financial strengths [3][5] 2. **Transaction Terms**: Accelerant stockholders will receive 0.4274 shares of Alumis stock for each share they own, resulting in approximately 55% ownership for Alumis stockholders and 45% for Accelerant stockholders [4] 3. **Leadership Structure**: The current leadership team of Alumis will remain in place post-merger, and the combined company will operate under the Alumis name [4] 4. **Financial Position**: The pro forma cash position at the end of 2024 is projected to be $737 million, providing a cash runway into 2027 [17] 5. **Pipeline Overview**: Alumis focuses on precision immunology, with two clinical-stage TIK2 inhibitors, ESSCAR001 and A5, targeting immune-mediated diseases like psoriasis and lupus [6][8] 6. **Upcoming Milestones**: Top-line data readouts for ESSCAR001 in psoriasis are expected in the first half of 2026, and for the Phase IIb LUMUS trial in lupus in 2026 [7] 7. **Lonigutumab Development**: The merger adds lonigutumab, an anti-IGF-1R therapy for thyroid eye disease, to the portfolio, which has shown promising data [9][10] 8. **Market Potential**: There is significant unmet need in the thyroid eye disease market, and lonigutumab is expected to have a differentiated safety profile compared to existing therapies [58] 9. **Capital Efficiency**: Both companies emphasize a commitment to capital efficiency in their operations and development strategies [16][11] 10. **Enrollment Strategies**: Efforts are ongoing to accelerate enrollment in clinical trials, particularly for psoriasis, leveraging the combined resources of both companies [54] Other Important but Overlooked Content 1. **Forward-Looking Statements**: The call included caution regarding reliance on forward-looking statements, highlighting potential risks and uncertainties [2][3] 2. **Operational Discipline**: Alumis has a history of managing costs prudently to ensure maximum return on investment, which will continue post-merger [17] 3. **Synergies from Merger**: While immediate development synergies may not be evident, the merger is expected to reduce operational redundancies and enhance financial stability [62] 4. **Focus on Execution**: The primary focus remains on executing existing programs and understanding how to advance the development of lonigutumab efficiently [46] This summary encapsulates the critical aspects of the conference call regarding the merger between Alumis and Accelerant, highlighting the strategic, financial, and operational implications for both companies in the biotechnology sector.
Alumis Announces Positive Phase 1 Data for CNS Penetrant TYK2 Inhibitor, A-005
Globenewswire· 2024-12-19 13:00
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]