WAYNE, PA — Aclaris Therapeutics Inc. (Nasdaq: ACRS) raised $50 million in an October stock and warrant offering to finance an expanding pipeline of experimental treatments for inflammatory diseases, extending its projected operating runway into the first half of 2029 as quarterly losses increased.
The Wayne-based biotechnology company reported a third-quarter net loss of $18.5 million, compared with $14.6 million a year earlier, as spending increased on clinical trials and manufacturing for its drug candidates.
Aclaris ended September with $204.6 million in cash, cash equivalents and marketable securities, up from $151.4 million at the end of 2025.
In October, the company sold 7.8 million common shares and issued pre-funded warrants covering another 6.5 million shares, generating $50 million in gross proceeds through an offering underwritten by Leerink Partners, Piper Sandler and Cantor Fitzgerald.
Including the net proceeds from that financing, Aclaris expects to fund operations through the first half of 2029 without additional financing or business development transactions.
The extended funding horizon supports several clinical milestones scheduled through 2027, including studies of ATI-052, bosakitug and modzatinib.
Aclaris is prioritizing development of ATI-052, an experimental antibody designed to inhibit two inflammatory signaling pathways, following positive preliminary findings in separate Phase 1b proof-of-concept studies involving atopic dermatitis and asthma.
In patients with severe atopic dermatitis, ATI-052 produced a 45% placebo-adjusted mean improvement in the Eczema Area and Severity Index after eight weeks.
The study also reported a 78% placebo-adjusted EASI-50 response measure and a 43% placebo-adjusted mean improvement in itching severity at the same assessment point.
Responses persisted through 16 weeks among patients with available follow-up data, with monitoring continuing.
Additional analysis found changes in inflammatory protein expression in affected skin, with treated tissue showing a molecular profile more closely resembling unaffected skin.
The findings included changes across several inflammatory pathways associated with immune activity, tissue remodeling and itching.
In a separate Phase 1b asthma study, patients receiving a single dose of ATI-052 experienced a 59% mean reduction in fractional exhaled nitric oxide, a marker of airway inflammation, after 15 days. The reduction was 40% at day 29.
The study also found a placebo-adjusted improvement of 200 milliliters in forced expiratory volume in one second, a measure of lung function, at day 15.
Aclaris reported that ATI-052 was generally well tolerated in both studies, with no conjunctivitis observed.
The company plans to advance ATI-052 into a Phase 2b trial for eosinophilic esophagitis, a chronic inflammatory condition affecting the esophagus, in early 2027.
Management is also evaluating a second Phase 2b indication, likely atopic dermatitis or asthma.
The decision to prioritize eosinophilic esophagitis reflects the company’s assessment of the drug’s biological mechanism and its effort to concentrate development spending.
Aclaris expects another significant clinical milestone before the end of 2026, when it plans to report top-line results from its Phase 2 ADMIRATION trial of bosakitug.
The randomized, double-blind, placebo-controlled study is evaluating the experimental anti-TSLP antibody in 109 patients with moderate-to-severe atopic dermatitis.
The company is also preparing to begin a Phase 2b trial of modzatinib, an oral inhibitor of ITK and JAK3, in patients with lichen planus.
Initial clinical site activation is expected in November 2026.
Lichen planus is a chronic inflammatory disorder affecting the skin and mucous membranes. No therapies are currently approved specifically for the indication, according to Aclaris.
Another experimental compound, ATI-9494, is approaching a regulatory milestone.
Aclaris expects to submit an investigational new drug application to the U.S. Food and Drug Administration during the fourth quarter of 2026 for ATI-9494, a dual inhibitor of ITK and TXK.
Preclinical findings have shown activity against inflammatory immune pathways, with drug characteristics that could support once-daily dosing.
Chief Executive Officer Neal Walker identified the upcoming bosakitug results and initiation of the modzatinib trial as near-term priorities.
“We have a series of expected clinical and regulatory milestones throughout the rest of 2026 and 2027,” Walker stated.
The expanding clinical program has increased Aclaris’ operating expenses.
Research and development spending rose to $16.1 million in the third quarter from $13 million a year earlier, driven primarily by manufacturing and clinical development costs for ATI-052 and preclinical work on ATI-9494.
For the first nine months of 2026, research and development expenses increased to $49.8 million from $36.1 million.
General and administrative expenses rose to $6 million in the quarter from $4.9 million, reflecting higher professional and legal fees, personnel costs and stock-based compensation.
Nine-month administrative expenses increased to $18.8 million from $16.4 million.
Revenue declined to $1.5 million in the third quarter from $3.3 million a year earlier. Nine-month revenue fell to $5.1 million from $6.5 million.
The decreases primarily reflected a sales milestone under Aclaris’ licensing agreement with Sun Pharma that contributed to revenue in 2025.
The company reported a nine-month net loss of $59.8 million, compared with $45.1 million in the corresponding 2025 period.
Aclaris also recorded a $600,000 gain from revaluing contingent consideration in the third quarter, compared with a $100,000 charge a year earlier. The change reflected higher discount rates and revised sales estimates.
For the first nine months, the revaluation produced a $300,000 gain, compared with a $1.9 million charge in 2025.
The company’s development strategy now centers on advancing ATI-052 into larger clinical studies while awaiting efficacy data for bosakitug and beginning patient testing of modzatinib.
The October financing gives Aclaris additional capital to pursue those programs through several planned clinical and regulatory milestones without relying on near-term fundraising.
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