Aclaris Therapeutics Q1 2024 Financial Results and Corporate Update

Aclaris Therapeutics, Inc., a biopharmaceutical company in the clinical stages of developing innovative treatments for immuno-inflammatory diseases, announced its financial results for the first quarter of 2024 and shared a corporate update. Dr. Neal Walker, the co-founder and Interim CEO & President of Aclaris, highlighted the decision to advance ATI-2138, an investigational ITK/JAK3 inhibitor with significant potential, into a Phase 2a trial for moderate to severe atopic dermatitis. Walker emphasized the company’s strategic focus on capital efficiency to further its novel therapies.

In the realm of Research and Development, Aclaris has notable advancements. ATI-2138, their oral ITK/JAK3 inhibitor, will enter Phase 2a trials following positive results from a Phase 1 multiple ascending dose trial reported in September 2023. Additionally, Aclaris is in the process of selecting a development candidate for a next-generation ITK selective inhibitor aimed at autoimmune diseases.

Another significant program is Lepzacitinib (ATI-1777), a topical JAK 1/3 inhibitor. Aclaris announced positive top-line results from a Phase 2b trial for atopic dermatitis in January 2024. The company is actively seeking a global development and commercialization partner for this program, excluding Greater China, where Pediatrix Therapeutics holds exclusive rights.

Zunsemetinib (ATI-450), an oral MK2 inhibitor, is also under development. Aclaris plans to support Washington University in St. Louis in conducting Phase 1b/2 trials of zunsemetinib as a potential treatment for pancreatic and metastatic breast cancer. These trials are expected to be predominantly grant-funded.

Financially, Aclaris reported a net loss of $16.9 million for Q1 2024, a reduction from a loss of $28.2 million in the same period of 2023. Total revenue slightly decreased to $2.4 million from $2.5 million year-over-year, primarily due to lower contract research revenue. Notably, research and development expenses dropped to $9.8 million from $22.6 million, attributed to reduced costs in several areas including development activities for zunsmetinib, lepzacitinib, and ATI-2138, alongside lower compensation costs due to a decrease in headcount.

General and administrative expenses also decreased from $8.8 million to $6.8 million, driven by a reduction in headcount and higher forfeiture credits. Licensing expenses saw a slight decline from $1.1 million to $1.0 million, which was due to the achievement of a commercial milestone in the previous year partially offset by increased royalties from the Lilly license agreement. The revaluation of contingent consideration led to a $2.8 million loss for Q1 2024, compared to a gain of $0.8 million in Q1 2023.

Aclaris’ liquidity remains robust with cash, cash equivalents, and marketable securities totaling $161.4 million as of March 31, 2024, down from $181.9 million at the end of 2023. The reduction primarily reflects payments related to discontinued R&D programs and workforce reductions. The company expects lower cash expenditures in the upcoming quarters as these activities conclude.

Management will discuss these updates in a conference call and webcast today at 5:00 PM ET. Participants can access the webcast and accompanying slides through the Aclaris website, where the presentation will remain archived for 30 days.

Aclaris Therapeutics, Inc. remains dedicated to developing a robust pipeline of drug candidates aimed at addressing unmet needs in immuno-inflammatory diseases, leveraging a strong R&D framework focused on protein kinase regulation.