ACELYRIN(SLRN)

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$HAREHOLDER ALERT: The M&A Class Action Firm Investigates the Merger of Acelyrin, Inc. - SLRN
Prnewswire· 2025-02-07 01:16
Group 1 - Monteverde & Associates PC is investigating Acelyrin, Inc. regarding its proposed merger with Alumis Inc. [1] - Under the merger agreement, Acelyrin stockholders will receive 0.4274 shares of Alumis common stock for each share they own, resulting in Acelyrin stockholders owning approximately 45% of the combined company post-transaction [1] Group 2 - Monteverde & Associates PC is recognized as a Top 50 Firm by ISS Securities Class Action Services Report and has recovered millions for shareholders [1] - The firm operates from the Empire State Building in New York City and has a successful track record in trial and appellate courts, including the U.S. Supreme Court [2]
ACELYRIN (SLRN) M&A Announcement Transcript
2025-02-06 23:00
ACELYRIN (SLRN) 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 ...
ACELYRIN(SLRN) - 2024 Q4 - Annual Results
2025-02-06 22:19
Exhibit 2.1 STRICTLY CONFIDENTIAL Proposed Execution Version AGREEMENT AND PLAN OF MERGER by and among ALUMIS INC., ARROW MERGER SUB, INC. and ACELYRIN, INC. Dated as of February 6, 2025 TABLE OF CONTENTS | | | Page | | --- | --- | --- | | | ARTICLE I THE MERGER; CLOSING; SURVIVING CORPORATION | 2 | | 1.1 | The Merger | 2 | | 1.2 | Closing | 2 | | 1.3 | Effective Time | 3 | | 1.4 | Certificate of Incorporation | 3 | | 1.5 | Bylaws | 3 | | 1.6 | Directors of the Surviving Corporation | 3 | | 1.7 | Officers o ...
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 News Room· 2025-02-06 21:15
Topline data from Phase 3 ONWARD trials for Alumis’ ESK-001 in moderate-to-severe plaque psoriasis on track for readout in first half of 2026; Topline data from Phase 2b LUMUS trial in systemic lupus erythematosus on track for readout in 2026 Evaluation underway of development plan for ACELYRIN’s lonigutamab to confirm differentiation in a capital efficient manner Pro forma cash position of approximately $737 million as of December 31, 2024, provides runway into 2027, beyond expected multiple clinical reado ...
ACELYRIN, INC. Announces Additional Phase 2 Data and Phase 3 Program Design for Lonigutamab in Thyroid Eye Disease
Newsfilter· 2025-01-06 21:00
Totality of data observed with subcutaneous lonigutamab in Thyroid Eye Disease (TED) patients demonstrate potential for efficacy in line with standard of care and a more favorable safety profile Conducted positive end of Phase 2 FDA meeting; Phase 3 program expected to be initiated in Q1 2025 Topline Phase 3 data expected in second half of 2026; cash runway expected through mid-2027 Conference call to review unmet need in TED, new Phase 2 data and Phase 3 program design to be held today, January 6, 2025, at ...
ACELYRIN, INC. to Host Virtual Investor Event to Share new Phase 2 Data and Phase 3 Program Design for Subcutaneous Lonigutamab
Globenewswire· 2025-01-03 01:00
Core Viewpoint - ACELYRIN, INC. is hosting a virtual investor event on January 6, 2025, to present updated Phase 2 data for lonigutamab, which shows promise for treating Thyroid Eye Disease (TED) with a potential best-in-class efficacy and safety profile [1] Company Overview - ACELYRIN, INC. is a late-stage clinical biopharma company focused on developing transformative medicines in immunology [1][11] - The company's lead program, lonigutamab, is a subcutaneously delivered monoclonal antibody targeting the IGF-1 receptor, currently being investigated for TED [11] Upcoming Event Details - The virtual investor event will feature presentations from ACELYRIN's CEO, CMO, and CCO, along with external clinician perspectives on TED [2] - A live Q&A session will follow the presentations, and a recording will be available on the company's website for approximately 30 days [2] Thyroid Eye Disease (TED) Insights - TED is a vision-threatening autoimmune disease affecting over 100,000 people in the U.S., characterized by inflammation and expansion of tissues behind the eye, leading to symptoms like proptosis and diplopia [8] Lonigutamab Characteristics - Lonigutamab is a humanized IgG1 monoclonal antibody that binds to the IGF-1 receptor, showing more potency in preclinical assays compared to standard care [9][10] - The subcutaneous delivery method allows for longer-term and convenient dosing, potentially improving clinical response durability [10]
ACELYRIN(SLRN) - 2024 Q3 - Earnings Call Transcript
2024-11-14 02:38
Financial Data and Key Metrics Changes - The company ended Q3 2024 with $562.4 million in cash, a strong financial position [24] - Research and development expenses decreased to $31.6 million from $74.6 million in Q3 2023, primarily due to reduced clinical development activity [24] - General and administrative expenses were $12.3 million compared to $19.9 million in the same period last year, attributed to lower stock-based compensation [24] - The year-end cash guidance was updated to $435 million to $450 million, reflecting the resolution of manufacturing commitments [27] Business Line Data and Key Metrics Changes - The focus has shifted to developing lonigutamab for thyroid eye disease (TED), with positive proof-of-concept data shared earlier this year [5][7] - The company is in late-stage development for lonigutamab, with an adaptive Phase 2 trial ongoing to establish optimal dosing [10] - The Phase 2b/3 trial of izokibep in noninfectious non-anterior uveitis is expected to announce top-line results in December [13] Market Data and Key Metrics Changes - TED affects over 100,000 people in the U.S., indicating a significant market opportunity for lonigutamab [6] - The uveitis market has a high unmet need, with only corticosteroids and adalimumab as approved treatment options [17] - The company is considering uveitis as a potential orphan indication, which could change the market dynamics significantly [14] Company Strategy and Development Direction - The company has reprioritized its pipeline to focus on lonigutamab and izokibep, aiming for a differentiated approach in their development [5][12] - A Scientific and Patient Advisory Board has been established to provide strategic input as the company advances lonigutamab into Phase 3 development [13] - The company is exploring selective pipeline expansion in 2025, contingent on upcoming data [29] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the ability to start the Phase 3 program for lonigutamab in Q1 2025, following FDA alignment on dosing strategy [10] - The response from the physician and patient communities regarding lonigutamab has been positive, indicating a strong need for better treatment options [11] - The company is committed to disciplined capital allocation and maintaining a strong financial position to achieve clinical goals through 2027 [31] Other Important Information - The company has resolved outstanding manufacturing commitments for izokibep, transforming a significant contractual liability into a manageable expense [25] - An ATM facility has been established to provide future capital flexibility [30] Q&A Session Summary Question: What data did the FDA see during the end of Phase 2 meeting for lonigutamab? - The FDA reviewed data from the first three cohorts, which included doses from 25 mg to 100 mg, and the totality of this data informed the dosing decision for Phase 3 [36] Question: What gives confidence that efficacy in uveitis is Cmax driven? - The company has conducted significant work to understand the exposure that is commensurate with secukinumab, indicating that izokibep can penetrate the blood-retinal barrier effectively [42] Question: What would the capital commitment look like for the Phase 3 study in uveitis? - Specific estimates around the uveitis study will not be provided until data is available, but there is significant flexibility within the current runway to further develop uveitis if warranted [45] Question: Is the bar for success in uveitis really better than Humira? - Yes, the company considers adalimumab as the primary reference point and aims for a superior clinical profile compared to it [50] Question: How will biologically experienced patients impact the study results? - The study will stratify for biologically experienced patients to ensure equal representation in drug and placebo groups, allowing for a comprehensive understanding of the treatment's impact [70]
ACELYRIN(SLRN) - 2024 Q3 - Quarterly Report
2024-11-13 21:01
Table of Contents UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-Q (Mark One) x QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended September 30, 2024 OR o TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from _____ to_____. Commission File Number: 001-41696 | --- | --- | --- | |----------------------------------------------------|------------- ...
Acelyrin: Straight Move To Phase 3 TED Studies Makes It Must Watch
Seeking Alpha· 2024-09-20 20:33
This article is published by Terry Chrisomalis, who runs the Biotech Analysis Central pharmaceutical service on Seeking Alpha Marketplace. If you like what you read here and would like to subscribe to, I'm currently offering a two-week free trial period for subscribers to take advantage of. My service offers a deep-dive analysis of many pharmaceutical companies. The Biotech Analysis Central SA marketplace is $49 per month, but for those who sign up for the yearly plan will be able to take advantage of a 33. ...
ACELYRIN, INC. Announces Positive 16-week Data From its Global Phase 2b/3 Trial of Izokibep in Psoriatic Arthritis to be Shared During Late-Breaking Oral Presentation at EULAR 2024
Newsfilter· 2024-06-05 11:00
The Phase 2b/3 clinical trial (NCT05623345) is a global, multi center, randomized double-blind, placebo- controlled trial evaluating the safety and efficacy of izokibep dosed subcutaneously 160 mg every week (QW) or every two weeks (Q2W) and 80 mg every four weeks (Q4W) versus placebo. 351 adult patients with active PsA were enrolled across 71 sites in the United States and Europe and randomized across the four arms. For more information about the Phase 2b/3 PsA clinical trial, please visit www.clinicaltria ...