ACELYRIN, INC. Shares Business Update and Upcoming Milestones

ACELYRIN, INC., a biopharmaceutical company specializing in immunology, recently provided updates on corporate milestones and clinical trial progress. The company, which focuses on the rapid development and delivery of transformative medicines, highlighted several significant advancements and financial updates.

The CEO of ACELYRIN, Mina Kim, emphasized the company's commitment to advancing transformative medicines efficiently while maintaining responsible capital allocation. Kim noted the recent positive proof-of-concept data for lonigutamab as a subcutaneously delivered treatment for thyroid eye disease (TED). She also mentioned the positive top-line results from the PsA trial for izokibep, underscoring the upcoming results of the hidradenitis suppurativa program, which will shape the company's future strategies. Given the substantial capital required to fully develop izokibep across multiple indications, ACELYRIN is exploring all available options to ensure its success and facilitate its development and commercialization.

Pipeline Updates and Milestones:

- Izokibep in Hidradenitis Suppurativa (HS): Enrollment for the Phase 3 trial has been completed with 258 patients, and top-line data is expected in the third quarter of 2024.

- Lonigutamab in Thyroid Eye Disease (TED): Ongoing Phase 1/2 proof-of-concept trial data is being evaluated to determine the optimal dose for a Phase 2b/3 trial, with initiation planned for the second half of 2024.

- Izokibep in Uveitis (UV): Enrollment completion in the Phase 2b/3 trial is expected this month, with top-line data anticipated by the end of 2024.

- SLRN-517: Early evaluation is ongoing.

Financial Position:

ACELYRIN reported having cash, cash equivalents, and short-term marketable securities totaling $678.5 million as of March 31, 2024. This cash position is projected to fund operations into 2026. The company is considering alternatives to extend its cash runway further.

Recent Pipeline Updates:

- Lonigutamab: This humanized monoclonal antibody targets the insulin-like growth factor-1 receptor (IGF-1R) and is delivered subcutaneously. ACELYRIN reported positive proof of concept for lonigutamab in TED, showing rapid improvements in proptosis and clinical activity score (CAS) within three weeks of the first dose. The results were comparable to intravenous treatments and showed no serious adverse events.

- Izokibep: Designed to inhibit IL-17A, izokibep is being evaluated in several late-stage trials for conditions like hidradenitis suppurativa, psoriatic arthritis, and noninfectious uveitis. The Phase 2b/3 trial for PsA showed positive top-line data, meeting the primary endpoint with significant multi-domain responses. The trial demonstrated higher clinical responses compared to approved IL-17A agents.

- Hidradenitis Suppurativa: Although the primary endpoint in the Phase 2b trial did not meet statistical significance at week 16, longer-term data showed continuous improvement in disease manifestations through week 32. The longer-term results indicated consistent improvements and suggested a favorable safety profile compared to other IL-17A agents.

Leadership Changes:

ACELYRIN announced leadership changes, with Mina Kim appointed as Chief Executive Officer, and Shao-Lee, M.D., Ph.D., stepping down. Shephard Mpofu, M.D., has been promoted to Chief Medical Officer, and Gil Labrucherie has taken on the additional role of Chief Business Officer. Sanam Pangali has been promoted to Chief Legal Officer and Head of People.

ACELYRIN will attend the Jefferies Global Healthcare Conference, with Mina Kim participating in a fireside chat on June 5, 2024. The company will not host the previously scheduled Q1 2024 earnings call but will file the related 10-Q report by May 14, 2024.

ACELYRIN, INC., based in Los Angeles with operations in the San Francisco Bay area, focuses on identifying, acquiring, and accelerating the development of transformative medicines. The company is advancing lonigutamab for thyroid eye disease and izokibep for conditions including psoriatic arthritis and hidradenitis suppurativa.

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