Aclaris Therapeutics Q3 2024 Financial Results and Corporate Update

WAYNE, Pa., November 6, 2024 – Aclaris Therapeutics, Inc., a clinical-stage biopharmaceutical company listed on NASDAQ under the ticker ACRS, has released its financial results for the third quarter of 2024 and provided an update on its corporate activities. This quarter was significant for Aclaris as it marked the beginning of the dosing of the first patient in the Phase 2a clinical trial of ATI-2138, a potential treatment for moderate to severe atopic dermatitis. Dr. Neal Walker, the Interim President & CEO, emphasized that this development, along with a solid financial standing, highlights the company's dedication to a cost-effective development approach.

The company's research and development (R&D) efforts include several noteworthy programs. The ITK Inhibitor Program with ATI-2138, an investigational oral covalent ITK/JAK3 inhibitor, is currently in an ongoing Phase 2a open-label trial. This trial aims to assess the safety, tolerability, pharmacokinetics, efficacy, and pharmacodynamics of ATI-2138 in patients with atopic dermatitis, with top-line results expected in the first half of 2025. In addition, Aclaris is advancing a second-generation ITK selective inhibitor for autoimmune diseases.

Another key program is Lepzacitinib (ATI-1777), a topical "soft" JAK 1/3 inhibitor. Positive top-line results from a Phase 2b trial in atopic dermatitis were reported in January 2024. Aclaris is actively seeking a global partner for the development and commercialization of lepzacitinib, except in Greater China, where Pediatrix Therapeutics holds exclusive rights.

For Zunsemetinib (ATI-450), an investigational oral MK2 inhibitor, Aclaris plans to back Washington University in St. Louis in its Phase 1b/2 trials for treating pancreatic and metastatic breast cancer. These trials are expected to be primarily funded by grants awarded to the university.

Financially, as of September 30, 2024, Aclaris held $173.4 million in cash, cash equivalents, and marketable securities, down from $181.9 million at the end of 2023. The company expects this amount to sufficiently fund its operations into 2028, assuming no additional transactions or financing activities.

For the third quarter of 2024, Aclaris reported a net loss of $7.6 million, a significant improvement from the $29.3 million loss in the third quarter of 2023. Total revenue for the third quarter of 2024 was $4.3 million, a decrease from $9.3 million during the same period in the previous year. This decline was mainly due to higher milestones earned in 2023 compared to 2024.

Research and development expenses decreased markedly to $6.0 million in the third quarter of 2024 from $23.9 million in the prior year. This $17.9 million reduction was primarily due to costs associated with zunsemetinib and lepzacitinib development activities, and ATI-2138 development expenses, including those from a Phase 1 trial completed in September 2023. General and administrative expenses also fell to $5.7 million from $7.1 million in the previous year, driven by lower compensation-related costs. Licensing expenses dropped to $1.8 million from $7.3 million, largely due to higher milestones in the prior period. The revaluation of contingent consideration resulted in a loss of $0.8 million for the quarter, down from a $1.7 million loss in the previous year.

Year-to-date, Aclaris has reported a net loss of $35.5 million for the nine months ending September 30, 2024, compared to $87.0 million for the same period in 2023. Total revenue for this period was $9.5 million, down from $13.7 million in the previous year. The reduction in revenue was again attributed to higher milestones earned in the prior year. R&D expenses for the nine months were $24.6 million, significantly lower than the $71.7 million spent in the same period in 2023. General and administrative expenses also decreased to $17.2 million from $24.2 million, while licensing expenses dropped to $4.1 million from $9.0 million. The revaluation of contingent consideration resulted in a $3.8 million loss for the nine months, compared to a gain of $0.6 million in the previous year.

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