Aclaris Therapeutics Q2 2024 Financial Results and Corporate Update

Aclaris Therapeutics, Inc., a clinical-stage biopharmaceutical company focused on developing innovative treatments for immuno-inflammatory diseases, has disclosed its financial results for the second quarter of 2024 and provided a business update. Notably, the company has initiated Phase 2a study activities for ATI-2138 in atopic dermatitis and has strengthened its financial position through the sale of future OLUMIANT® royalties for up to $31.5 million.

Dr. Neal Walker, Interim President & CEO and Chair of the Board of Directors, expressed the company’s strategic direction: “With the underway study activities for our ATI-2138 Phase 2a trial in moderate to severe atopic dermatitis and completion of our royalty purchase agreement with OMERS, we are well-positioned to advance our strategic objectives.” He emphasized the company’s commitment to leveraging resources to maximize the potential of its drug candidates and create value for patients and shareholders.

Research and Development Updates

ITK Inhibitor Programs
ATI-2138 is an investigational oral covalent ITK/JAK3 inhibitor. Aclaris is activating clinical sites and anticipates enrolling patients soon for the Phase 2a open-label trial, which will assess safety, tolerability, pharmacokinetics, efficacy, and pharmacodynamics in subjects with moderate to severe atopic dermatitis.

Aclaris is also advancing a second-generation ITK selective inhibitor for autoimmune conditions to the development candidate selection phase.

Lepzacitinib (ATI-1777)
Lepzacitinib, a topical “soft” JAK 1/3 inhibitor, showed positive top-line results in a Phase 2b trial for atopic dermatitis in January 2024. Aclaris is seeking a global development and commercialization partner for this program, with the exception of Greater China, where Pediatrix Therapeutics holds exclusive rights.

Zunsemetinib (ATI-450)
Zunsemetinib is an investigational oral small molecule MK2 inhibitor. Aclaris plans to support Washington University in St. Louis in its Phase 1b/2 trials for pancreatic and metastatic breast cancer. These trials are expected to be primarily grant-funded.

Financial Overview

Liquidity and Capital Resources
As of June 30, 2024, Aclaris had cash, cash equivalents, and marketable securities totaling $149.9 million, down from $181.9 million as of December 31, 2023. In July 2024, the company received a $26.5 million upfront payment and may receive another $5.0 million based on certain sales milestones from the OLUMIANT® royalty and milestone sale to OMERS Life Sciences. Aclaris projects that its current financial resources will fund operations into 2028, not accounting for new business transactions, additional financing, or strategic review outcomes.

Second Quarter 2024 Financial Results
The company reported a net loss of $11.0 million for Q2 2024, a significant improvement from the $29.6 million loss in Q2 2023. Total revenue increased to $2.8 million, up from $1.9 million in the same period the previous year, primarily due to higher royalties under the Lilly license agreement.

Research and development (R&D) expenses for Q2 2024 were $8.8 million, down from $25.3 million in Q2 2023. The reduction was attributed to lower development expenses for Zunsemetinib, Lepzacitinib, and ATI-2138, as well as reduced compensation-related expenses due to a decreased headcount.

General and administrative (G&A) expenses decreased to $4.8 million from $8.3 million in the prior year period, driven by lower compensation-related costs and the recognition of bad debt in the previous year. 

Licensing expenses were $1.3 million, up from $0.6 million, owing to increased royalties under the Lilly license agreement. The revaluation of contingent consideration showed a $0.2 million loss, compared to a $1.5 million gain in Q2 2023.

Year-to-Date 2024 Financial Results
For the six months ending June 30, 2024, net loss was $27.9 million, down from $57.7 million for the same period in 2023. Total revenue for the first half of 2024 was $5.2 million, compared to $4.4 million in the first half of 2023.

R&D expenses decreased to $18.6 million from $47.9 million, due to lower development costs for Zunsemetinib, Lepzacitinib, and ATI-2138, and reduced compensation-related expenses. G&A expenses fell to $11.6 million from $17.1 million, while licensing expenses rose to $2.3 million from $1.6 million. The revaluation of contingent consideration resulted in a $3.0 million loss, compared to a $2.3 million gain in the prior year period.

Aclaris Therapeutics continues to advance its pipeline of novel drug candidates aimed at addressing unmet needs in immuno-inflammatory diseases.

How to obtain the latest research advancements in the field of biopharmaceuticals?

In the Synapse database, you can keep abreast of the latest research and development advances in drugs, targets, indications, organizations, etc., anywhere and anytime, on a daily or weekly basis. Click on the image below to embark on a brand new journey of drug discovery!