A-005 / Alumis - LARVOL DELTA

Alumis and ACELYRIN Announce Amended Merger Agreement (GlobeNewswire) - "Merger maximizes the potential value for ACELYRIN stockholders and creates a stronger combined company, best-positioned to realize long-term value of multiple late-stage assets...Alumis Inc...and ACELYRIN, INC...announced an amendment to the existing terms of their previously announced merger agreement...Under the terms of the amended agreement, ACELYRIN stockholders will now receive 0.4814 shares of Alumis common stock for each share of ACELYRIN common stock owned, representing a meaningful increase in the ownership percentage of the combined company over the original definitive merger agreement....'We continue to believe that this combination is the most value-maximizing path forward for ACELYRIN stockholders and that Alumis is the right partner to optimize development of lonigutamab.'"

M&A • Immunology • Multiple Sclerosis • Systemic Lupus Erythematosus • Thyroid Eye Disease

Alumis and ACELYRIN File Joint Definitive Proxy Statement for Proposed Merger (GlobeNewswire) - "Alumis Inc...and ACELYRIN, INC...have jointly filed a definitive proxy statement/prospectus with the U.S. Securities and Exchange Commission in connection with the proposed merger of the two companies. The joint proxy statement/prospectus are being mailed to all Alumis and ACELYRIN stockholders entitled to vote...Topline data from Phase 2b LUMUS trial in systemic lupus erythematosus on track for readout in 2026; Phase 2 clinical trial initiation for Alumis’ A-005 in MS...Pro forma cash of approximately $737 million as of December 31, 2024, provides runway into 2027, beyond multiple expected clinical readouts....By combining assets, resources and talent, including members of ACELYRIN’s lonigutamab program, the combined company will be well positioned to maximize the value of its pipeline."

M&A • New P2 trial • P2b data • Multiple Sclerosis • Systemic Lupus Erythematosus • Thyroid Eye Disease

Alumis Reports Year End 2024 Financial Results and Highlights Recent Achievements (GlobeNewswire) - "Upon the close of the transaction, Alumis stockholders will own approximately 55% of the combined company and ACELYRIN stockholders will own approximately 45% of the combined company, on a fully diluted basis....Closing of merger transaction with ACELYRIN (2Q 2025)....Research and development expenses were $265.6 million for the year ended December 31, 2024, compared to $137.7 million for the year ended December 31, 2023. The increase was driven by a clinical milestone payment of $23.0 million related to the prior acquisition of FronThera, an increase in contract research and manufacturing and clinical trial costs for the ESK-001 and A-005 programs..."

M&A • Multiple Sclerosis • Psoriasis • Systemic Lupus Erythematosus

Alumis and ACELYRIN Reaffirm Strategic and Financial Rationale of Proposed Merger (GlobeNewswire) - "A combined, differentiated late-stage portfolio of therapies and increased resources enabling the development of life-changing medicines. The combined company will have a diversified portfolio of late-stage clinical assets for validated targets that are set to meaningfully change the treatment paradigm for patients in large, well-established multi-billion dollar markets. These programs, including ESK-001 in moderate-to-severe plaque psoriasis and systemic lupus erythematosus, lonigutamab for thyroid eye disease, and A-005 in multiple sclerosis, offer multiple, high-value catalysts that can be achieved with the financial resources of the combined company...Alumis and ACELYRIN had cash, cash equivalents and marketable securities of approximately $289 million and approximately $448 million, respectively, on a preliminary basis, as of December 31, 2024."

M&A • Multiple Sclerosis • Psoriasis • Systemic Lupus Erythematosus • Thyroid Eye Disease

A-005, a Selective Oral Brain Penetrant TYK2 Inhibitor, Modulates Astrocytes and Microglia (ACTRIMS Forum 2025) - "Our results further demonstrate the in vitro potency and in vivo efficacy of a small molecule TYK2 inhibitor. These data provide insight into additional peripheral and CNS immune mechanisms relevant to MS pathology that are dependent on TYK2 activity. TYK2 inhibition may represent a novel approach to treat neuroinflammation and disability in MS and other diseases of the CNS."

CNS Disorders • Immunology • Inflammation • Multiple Sclerosis • IFNA1 • IL12A • IL23A • TYK2

Safety, Tolerability, and Pharmacokinetics of A-005: A Selective Brain-Penetrant TYK2 Inhibitor for CNS Inflammatory Diseases in Healthy Volunteers Following Single and Multiple Ascending Doses (ACTRIMS Forum 2025) - "A-005 demonstrated a favorable safety and tolerability profile, with rapid absorption, dose-proportional linear exposure, and minimal accumulation after multiple doses for 14 days. Phase 1 data for A-005 supports the selection of the dose range for future patient trials and continued clinical development for the treatment of MS and potentially additional neuroinflammatory conditions."

Clinical • PK/PD data • CNS Disorders • Inflammation • Multiple Sclerosis • TYK2

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) - "Alumis...today announced the Company will give two data presentations on A-005, a potent, selective, central nervous system (CNS) penetrant tyrosine kinase 2 (TYK2) inhibitor, on Friday, February 28, 2025, at the 10th Annual Americas Committee for Treatment and Research in Multiple Sclerosis (ACTRIMS) Forum 2025....'The Phase 1 clinical data demonstrate that A-005 was well tolerated and achieved maximal TYK2 inhibition across a broad dose range. These data support our plans to commence a Phase 2 clinical trial in patients with multiple sclerosis in the second half of this year.'"

New P2 trial • P1 data • Multiple Sclerosis

Combined Pipeline (GlobeNewswire) - "(i) ESK-001:...Alumis expects a Phase 2 OLE 52-week data update in PsO in 2025, Phase 3 topline data for PsO in the first half of 2026 and Phase 2b topline data for SLE in 2026...; (ii) A-005:... Alumis expects initiation of its Phase 2 clinical trial in MS in the second half of 2025 with Phase 2 topline data expected in 2026."

New P2 trial • P2 data • P3 data: top line • Multiple Sclerosis • Psoriasis • Systemic Lupus Erythematosus

Alumis and ACELYRIN to Merge Creating a Late-Stage Clinical Biopharma Company Dedicated to Innovating, Developing and Commercializing Transformative Therapies for Immune-mediated Diseases (GlobeNewswire) - "Alumis...and ACELYRIN...announced a definitive merger agreement under which Alumis and ACELYRIN will merge in an all-stock transaction....The combined company will benefit from a differentiated late-stage portfolio of therapies and increased resources enabling the development of life-changing medicines....Under the terms of the agreement, ACELYRIN stockholders will receive 0.4274 shares of Alumis common stock for each share of ACELYRIN common stock owned. Upon the close of the transaction, Alumis stockholders will own approximately 55% of the combined company and ACELYRIN stockholders will own approximately 45% of the combined company, on a fully diluted basis."

M&A • Multiple Sclerosis • Parkinson's Disease • Psoriasis • Systemic Lupus Erythematosus • Thyroid Eye Disease

Alumis Announces Positive Phase 1 Data for CNS Penetrant TYK2 Inhibitor, A-005 (GlobeNewswire) - P=NA | N=NA | "'A-005 is the first reported allosteric TYK2 inhibitor that has demonstrated the ability to cross the human blood-brain barrier to address inflammation within the central nervous system (CNS). Based on these data, we expect to begin a Phase 2 clinical trial in patients with multiple sclerosis (MS) in the second half of 2025,'...In the clinical trial, A-005 was well tolerated with no serious adverse events reported. A-005 demonstrated the ability to penetrate into the CNS with significant and prolonged exposure in the cerebral spinal fluid (CSF)...In the single-ascending dose cohorts, drug exposures generally increased in a dose proportional manner, rapidly reaching peak drug concentration (Tmax) and half-lives of up to 12 hours...Alumis plans to present data from the Phase 1 clinical trial at the Americas Committee for Treatment and Research in Multiple Sclerosis (ACTRIMS) Forum 2025 taking place February 27- March 1, 2025, in West Palm Beach, Florida."

New P2 trial • P1 data • CNS Disorders • Immunology • Multiple Sclerosis

Alumis Reports Second Quarter 2024 Financial Results and Highlights Recent Development and Corporate Achievements (GlobeNewswire) - "Anticipated Milestones - 2024: ESK-001 Phase 2 OLE data update in psoriasis (3Q 2024)...2025: A-005: Initiation of Phase 2 clinical trial in multiple sclerosis (MS); ESK-001: Phase 2 OLE 52-week data update in psoriasis; Third pipeline program: Investigational New Drug Application filing for third clinical candidate; 2026: ESK-001: Psoriasis Phase 3 topline data; ESK-001: SLE Phase 2b topline data; A-005: MS Phase 2 topline data."

New P2 trial • P2 data • P2b data • P3 data: top line • Immunology • Lupus • Multiple Sclerosis • Psoriasis • Systemic Lupus Erythematosus

Alumis sets out IPO ambitions to fund TYK2 inhibitor through phase 3 psoriasis trials (FierceBiotech) - "...Alumis plans to use part of the IPO haul to advance the development of its lead asset, an allosteric tyrosine kinase 2 (TYK2) inhibitor called ESK-001, into multiple phase 3 trials in moderate to severe plaque psoriasis later this year. Alumis will also complete ongoing phase 2 trials in a type of eye inflammation called uveitis as well as in systemic lupus erythematosus...Some of the money will be used to push ahead with a phase 1 trial of another allosteric TYK2 inhibitor, dubbed A-005, in healthy volunteers, the company explained in the filing."

Commercial • New P3 trial • Trial status • Psoriasis • Systemic Lupus Erythematosus • Uveitis