Aclaris Therapeutics reported a wider loss for the third quarter and first nine months of 2026, while outlining a series of clinical milestones for its inflammation-focused drug pipeline. The company also raised $50 million in October through a stock and pre-funded warrant offering, which it says extends its expected cash runway through the first half of 2029.
The clinical update highlighted positive early results for ATI-052 in atopic dermatitis and asthma, a planned Phase 2b study of modzatinib in lichen planus, and expected readouts for bosakitug and an investigational drug application for ATI-9494.
Pipeline and clinical milestones
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ATI-052 showed early activity in atopic dermatitis. In a Phase 1b proof-of-concept trial in severe disease, patients had a 45% placebo-adjusted mean improvement in EASI skin-severity scores from baseline at week eight. The company also reported a 78% placebo-adjusted EASI-50 result and a 43% placebo-adjusted improvement in itch. Responses remained durable through week 16 among patients with available follow-up, which is ongoing. Aclaris said the treatment was well tolerated, with no cases of conjunctivitis observed.
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Skin analyses suggested broad changes in inflammation. At week eight, protein patterns in treated lesions moved toward those seen in non-lesional skin. Aclaris reported changes across several inflammatory pathways, as well as pathways associated with tissue remodeling and itch.
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ATI-052 also produced early asthma results. After a single dose in a Phase 1b proof-of-concept trial, patients had a mean 59% reduction in fractional exhaled nitric oxide, a measure of airway inflammation, by day 15; the reduction was 40% at day 29. At day 15, lung function, measured by FEV1, improved by 200 milliliters on both an absolute and placebo-adjusted basis. The company said safety and tolerability were consistent with the atopic dermatitis trial, including no observed conjunctivitis.
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Aclaris plans to focus ATI-052’s initial Phase 2b development on eosinophilic esophagitis. The company considers the drug a strong mechanistic fit for the condition and expects to assess another potential Phase 2b indication shortly, likely atopic dermatitis or asthma. Chief Executive Neal Walker said the company expects to start a Phase 2b trial in eosinophilic esophagitis early next year.
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Bosakitug’s Phase 2 atopic dermatitis results are expected in the fourth quarter of 2026. The ADMIRATION trial is testing the investigational antibody in 109 people with moderate-to-severe atopic dermatitis.
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A Phase 2b trial of modzatinib in lichen planus is expected to begin in the fourth quarter of 2026. Startup work is underway, with the first site activation expected in November. Lichen planus is a chronic inflammatory skin condition for which Aclaris says there are no approved therapies.
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Aclaris expects to file an investigational new drug application for ATI-9494 in the fourth quarter of 2026. The candidate inhibits ITK and TXK. The company cited preclinical findings including activity against immune responses and a prolonged half-life, which it says may support flexible, once-daily dosing.
Financial position
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Cash and investments totaled $204.6 million at September 30, 2026, up from $151.4 million at the end of 2025. In October, Aclaris sold 7.8 million common shares and issued pre-funded warrants covering 6.5 million additional shares for $50 million in gross proceeds. Including net proceeds from the offering, the company expects to fund operations through the first half of 2029, excluding any future business-development deals or additional financing.
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The net loss increased. Aclaris reported a third-quarter net loss of $18.5 million, compared with $14.6 million a year earlier. For the first nine months of 2026, the net loss was $59.8 million, up from $45.1 million in the comparable 2025 period.
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Revenue declined year over year. Third-quarter revenue was $1.5 million, versus $3.3 million a year earlier; nine-month revenue was $5.1 million, compared with $6.5 million. Aclaris attributed the declines mainly to a sales milestone under its Sun Pharma license agreement that had boosted revenue in the 2025 comparison periods.
The October financing adds capital but also increases the potential share count through both the newly issued stock and warrants. The company’s stated runway estimate incorporates the offering’s net proceeds and does not assume additional financing or business-development proceeds.