Aclaris Therapeutics — Third Quarter 2026 Earnings Summary

Financial Performance:

• Total revenue was $1.5 million for the three months ended September 30, 2026, a decrease from $3.3 million in the same period in 2025; year-to-date revenue was $5.1 million compared to $6.5 million in 2025, driven primarily by a sales milestone achieved under the Sun Pharma license agreement in the prior year period.
• Net loss was $18.5 million for the quarter ended September 30, 2026, compared to $14.6 million in the prior year period; year-to-date net loss was $59.8 million compared to $45.1 million in 2025.
• Research and development expenses increased to $16.1 million for the quarter (from $13.0 million in 2025) and $49.8 million year-to-date (from $36.1 million in 2025), driven by manufacturing and clinical development costs for ATI-052 and preclinical costs for ATI-9494.
• General and administrative expenses rose to $6.0 million for the quarter (from $4.9 million in 2025) and $18.8 million year-to-date (from $16.4 million in 2025), primarily due to increased professional, legal, personnel, and stock-based compensation expenses.
• Aclaris reported a $0.6 million gain from the revaluation of contingent consideration for the quarter ended September 30, 2026, compared to a $0.1 million charge in the prior year period.
• Cash, cash equivalents, and marketable securities totaled $204.6 million as of September 30, 2026, up from $151.4 million as of December 31, 2025.
• Net cash used in operating activities was $62.1 million for the nine months ended September 30, 2026, compared to $34.0 million in the same period in 2025.

Guidance and Future Outlook:

• The Company expects its current cash resources to be sufficient to fund operations through the first half of 2029, without accounting for potential business development transactions or additional financing.
• Top line results from the Phase 2 ADMIRATION trial of bosakitug in atopic dermatitis are expected in the fourth quarter of 2026.
• A Phase 2b trial of modzatinib in lichen planus is expected to initiate in the fourth quarter of 2026.
• A Phase 2b trial of ATI-052 in eosinophilic esophagitis is expected to begin early in 2027.
• An Investigational New Drug (IND) application for ATI-9494 is on track for filing in the fourth quarter of 2026.
• The Company intends to complete an assessment of an additional Phase 2b indication for ATI-052 shortly, likely in atopic dermatitis or asthma.

Business Segments and Product Lines:

• ATI-052 (Bispecific Anti-TSLP/IL-4Rα Antibody):
  • Phase 1b proof-of-concept trials in severe atopic dermatitis showed a 45% placebo-adjusted mean change in EASI score at week 8 and a 78% placebo-adjusted EASI-50 rate at week 8.
  • Patients treated with ATI-052 experienced a 43% placebo-adjusted mean improvement in itch (PP-NRS) at week 8.
  • Pharmacodynamic results indicated marked normalization of lesional skin proteome toward baseline at week 8, with modulation across Th1, Th2, and Th17/Th22 pathways.
  • Phase 1b trials in asthma demonstrated a 59% mean absolute reduction in fractional exhaled nitric oxide (FeNO) 15 days after a single dose and a 200 ml improvement in FEV1 at day 15.
  • ATI-052 demonstrated a favorable safety profile with no observations of conjunctivitis in either indication.
• Bosakitug (ATI-045):
  • The Phase 2 ADMIRATION trial is evaluating the efficacy and safety of bosakitug in 109 patients with moderate-to-severe atopic dermatitis.
• Modzatinib (ATI-2138):
  • An investigational oral ITK/JAK3 inhibitor; first site activation for the Phase 2b lichen planus trial is expected in November 2026.
  • Lichen planus is described as an unaddressed chronic, inflammatory, CD8-driven interface dermatitis with no currently approved therapies.
• ATI-9494:
  • An investigational dual inhibitor of ITK and TXK demonstrating potent blockade of Th1 and Th2 responses, a prolonged half-life, and high potency against ITK.
  • The profile suggests potential for low drug burden, dosing flexibility, and once-daily administration.

Market and Competitive Landscape:

• The Company focuses on immuno-inflammatory diseases where patients lack satisfactory treatment options.
• The lichen planus indication is characterized as unaddressed with no approved therapies currently available.

Risks and Challenges:

• Forward-looking statements involve risks including uncertainties inherent in preclinical and clinical studies, risks associated with interim and top-line data, and reliance on third parties.
• Risks include the ability to enter into strategic partnerships on commercially reasonable terms and uncertainties regarding the macroeconomic environment.
• Actual results may differ materially from expectations regarding development timelines, clinical data, and cash runway sufficiency.

Management Commentary and Tone:

• CEO Dr. Neal Walker stated that recent progress reflects continued execution toward the objective of raising the efficacy ceiling for inflammatory disorders.
• Management highlighted "strongly positive primary analysis results" from the ATI-052 Phase 1b trials and expressed confidence in a series of expected clinical and regulatory milestones throughout 2026 and 2027.
• The Company emphasized its development strategy and capital management discipline in prioritizing the Phase 2b development of ATI-052 in eosinophilic esophagitis.

Other Key Points:

• In October 2026, the Company sold 7.8 million shares of common stock and issued pre-funded warrants to purchase 6.5 million shares for aggregate gross proceeds of $50.0 million pursuant to an underwriting agreement with Leerink Partners LLC, Piper Sandler & Co., and Cantor Fitzgerald & Co.
• Common stock outstanding increased to 150.8 million as of September 30, 2026, from 120.5 million as of December 31, 2025.
• Total stockholders' equity increased to $166.8 million as of September 30, 2026, from $103.1 million as of December 31, 2025.
• Stock-based compensation expense totaled $3.0 million for the quarter and $8.9 million year-to-date in 2026.