Aclaris Therapeutics Reports Third Quarter 2026 Financial Results and Provides Corporate and Clinical Update

Nine-month operating cash use rose to $62.076 million from $33.982 million as clinical development advanced.

Rhea-AI Summary

Aclaris Therapeutics (NASDAQ: ACRS) reported a third-quarter net loss of $18.510 million alongside clinical results and upcoming development milestones. Revenue fell to $1.481 million from $3.299 million a year earlier; net loss was $14.614 million in the prior-year quarter.

ATI-052 Phase 1b results included a 45% placebo-adjusted mean improvement in eczema severity at week 8 and a 200 ml placebo-adjusted lung-function improvement in asthma at day 15. Aclaris plans Phase 2b development initially in eosinophilic esophagitis in early 2027. Bosakitug Phase 2 results, modzatinib Phase 2b initiation and an ATI-9494 investigational-drug application are expected in fourth-quarter 2026.

Cash and investments totaled $204.607 million at September 30. An October offering raised $50.0 million gross; including its net proceeds, Aclaris expects funding through first-half 2029, excluding potential business development transactions or additional financing.

22 points · 0 major

PositiveiHow this balance works

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Rhea-AI gives every point it takes from this document a weight. Minor counts 1, Moderate 3 and Major 9, so one Major point outweighs several Minor ones. The bar adds up the weights on each side, and when neither side holds more than 65% of the total the balance reads Mixed.

It reads the document as published, with the same rules for every company, and it does not look at what the market expected or at how the stock traded, so a point can be objectively good on a day the stock falls.

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0 major · 9 points

Hollow bars mark forward-looking points. How the balance works

Positive

• Moderate pointCash and investments increased to $204.607 million at September 30, 2026, from $151.363 million at year-end 2025.
• Moderate pointOctober offering raised $50.0 million in gross proceeds. 8.8% of market cap
• Moderate point. Forward-looking: it has not happened yet and may not happen.Aclaris expects funding through first-half 2029, including October net proceeds, excluding potential business development transactions or additional financing.
• Moderate pointATI-052 eczema trial showed 45% placebo-adjusted mean improvement in the skin-severity score at week 8.
• Moderate pointATI-052 asthma lung function improved 200 ml, placebo-adjusted and absolute, at day 15.
• Moderate point. Forward-looking: it has not happened yet and may not happen.Aclaris plans initial ATI-052 Phase 2b development in eosinophilic esophagitis, starting in early 2027.
• Moderate point. Forward-looking: it has not happened yet and may not happen.Bosakitug Phase 2 results in 109 eczema patients are expected in fourth-quarter 2026.
• Moderate point. Forward-looking: it has not happened yet and may not happen.Modzatinib Phase 2b initiation is expected in fourth-quarter 2026, with first site activation expected in November.

14 minor points

• Minor pointATI-052 eczema trial reported 78% placebo-adjusted EASI-50, the measure of at least 50% skin-severity improvement, at week 8.
• Minor pointATI-052 eczema responses persisted through week 16 in patients with available data; follow-up remains ongoing.
• Minor pointATI-052 reduced patient-reported itch by 43% versus placebo at week 8.
• Minor pointATI-052 skin samples showed week-8 normalization toward non-lesional skin protein expression and reduced inflammatory-pathway activity.
• Minor pointATI-052 asthma trial showed a 59% mean absolute reduction in exhaled nitric oxide, an inflammation marker, at day 15.
• Minor pointATI-052 asthma trial showed a 40% reduction in exhaled nitric oxide at day 29.
• Minor pointATI-052 was well tolerated in eczema; asthma safety was consistent, with no conjunctivitis observed in either trial.
• Minor point. Forward-looking: it has not happened yet and may not happen.Aclaris expects to select an additional ATI-052 Phase 2b indication shortly, likely eczema or asthma.
• Minor point. Forward-looking: it has not happened yet and may not happen.ATI-9494 investigational new drug application remains on track for fourth-quarter 2026.
• Minor pointCost of revenue fell to $0.189 million in Q3 and $0.802 million year-to-date, from $0.538 million and $1.559 million.
• Minor pointLicensing expenses fell to $1.132 million in Q3 and $3.760 million year-to-date, from $1.911 million and $4.256 million.
• Minor pointContingent-consideration revaluation generated $0.600 million Q3 gain versus $0.100 million charge; nine-month gain was $0.300 million versus $1.900 million charge.
• Minor pointNon-cash royalty income rose to $0.985 million in Q3 and $2.811 million year-to-date, from $0.716 million and $2.510 million.
• Minor pointTotal liabilities declined to $49.358 million at September 30, 2026, from $57.378 million at year-end 2025.

Negative

• Moderate pointQ3 net loss widened to $18.510 million from $14.614 million; loss per share remained $0.12.
• Moderate pointNine-month operating cash use increased to $62.076 million from $33.982 million.
• Moderate pointOctober issuance of 7.8 million shares and pre-funded warrants for 6.5 million shares dilutes existing holders.
• Moderate pointR&D expenses rose to $16.066 million in Q3 and $49.789 million year-to-date, from $13.028 million and $36.061 million.
• Minor pointNine-month net loss widened to $59.839 million, or $0.43 per share, from $45.128 million, or $0.37.

4 minor points

• Minor pointQ3 revenue declined to $1.481 million from $3.299 million a year earlier.
• Minor pointNine-month revenue declined to $5.106 million from $6.531 million a year earlier.
• Minor pointAdministrative expenses rose to $6.038 million in Q3 and $18.829 million year-to-date, from $4.871 million and $16.396 million.
• Minor pointNine-month interest income fell to $5.124 million from $6.003 million; Q3 increased to $1.849 million from $1.819 million.

News Explained

At September 30, 2026, Aclaris reported 150,825,196 common shares outstanding; in October, it sold 7.8 million shares and issued pre-funded warrants for 6.5 million shares, which would reduce existing holders’ ownership percentages if exercised.

Key Figures

Cash and marketable securities: $204.6 million October offering proceeds: $50.0 million gross Cash runway: Through the first half of 2029 +5 more

Cash and marketable securities

$204.6 million

As of September 30, 2026

October offering proceeds

$50.0 million gross

October 2026 common stock and pre-funded warrant offering

Cash runway

Through the first half of 2029

Taking into account net proceeds from the October offering

Net loss

$18.5 million

Third quarter of 2026; compared with $14.6 million in Q3 2025

Total revenue

$1.5 million

Third quarter of 2026; compared with $3.3 million in Q3 2025

Placebo-adjusted EASI change

45%

ATI-052 Phase 1b proof-of-concept trial in atopic dermatitis, week 8

FeNO reduction

59%

Mean absolute reduction 15 days after a single ATI-052 dose in asthma

FEV1 improvement

200 ml

Placebo-adjusted and absolute improvement at day 15 in the ATI-052 asthma trial

Previous Earnings Reports

2 past events · Latest: Aug 06

Same Type 2 events

1. Aug 06

   Q2 2026 earnings

   24h Move

   -4.3%

   Cash runway was expected through end of 2028 after the quarter-end financing.

2. Nov 06

   Q3 2025 earnings

   24h Move

   +0.4%

   Q3 net loss widened year over year while the company reported clinical progress.

24h Move is the share-price change in the day after each event; other market factors may also have contributed.

Key Terms

easi score, fractional exhaled nitric oxide (feno), forced expiratory volume in 1 second (fev1), investigational new drug (ind), +1 more

5 terms

easi score medical

"45% placebo-adjusted mean change in EASI score from baseline at week 8"

EASI score is the Eczema Area and Severity Index, a clinician‑rated scale used to quantify the severity and extent of atopic dermatitis (eczema). It scores four signs (redness/erythema, thickness/induration/edema, scratching/excoriation, and lichenification) in four body regions by combining severity grades with the percentage of each region affected; the weighted regional scores are summed to produce a total from 0 (no disease) to 72 (most severe). As a clinician-assessed measure, it captures objective skin signs and extent but does not include patient-reported symptoms such as itch or sleep disturbance.

fractional exhaled nitric oxide (feno) medical

"reduction in fractional exhaled nitric oxide (FeNO) (45 ppb)"

Fractional exhaled nitric oxide (FeNO) is a simple breath test that measures tiny amounts of nitric oxide released from inflamed airways, acting like a smoke alarm for the lungs to signal allergic or eosinophilic airway inflammation often associated with asthma. As a noninvasive biomarker used to diagnose, monitor and guide treatment, FeNO influences demand for point-of-care devices, shapes clinical trial endpoints and prescribing decisions, and affects reimbursement and market potential for diagnostics and respiratory drugs.

forced expiratory volume in 1 second (fev1) medical

"improvement in Forced Expiratory Volume in 1 Second (FEV1) at day 15"

Forced expiratory volume in 1 second (FEV1) measures how much air a person can forcefully blow out in the first second of a standard lung function test, giving a simple number for airflow and breathing capacity. Investors care because changes in FEV1 are a common, objective way to judge whether respiratory drugs, devices, or treatments are working and are used by regulators and clinicians as trial endpoints—think of it like a car’s horsepower score that helps assess performance and market potential.

investigational new drug (ind) regulatory

"Filing of Investigational New Drug (IND) Application"

An investigational new drug (IND) is a drug or biologic that is being tested but has not yet been approved for general use; it is the application and formal status that allows a company to begin human clinical trials under regulator oversight. Investors care because an IND marks the transition from lab work to human testing — like getting a permit to run real-world experiments — which creates important milestones, costs, timelines and regulatory risk that drive a development-stage company's value.

pre-funded warrants financial

"issued pre-funded warrants to purchase 6.5 million shares"

Pre-funded warrants are financial instruments that give investors the right to purchase a company's stock at a set price, but with most or all of the purchase price paid upfront. They function like a coupon or gift card for stock, allowing investors to buy shares later at a fixed price, which can be beneficial if they want to avoid future price increases. This makes them important for investors seeking flexibility and certainty in their investment plans.

AI-generated analysis. How Rhea-AI works. Not financial advice.

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- Initiation of Phase 2b Trial of Modzatinib (ATI-2138) in Lichen Planus Expected in Fourth Quarter of 2026 -

- Timeline Reaffirmed for Top Line Results from Phase 2 ADMIRATION Trial of Bosakitug (ATI-045) in Atopic Dermatitis (AD) -

- Positive Primary Analysis Results Announced from Phase 1b Proof-of-Concept (POC) Trials of ATI-052 in AD and Asthma -

- Strong Cash Runway Expected to Enable Development of Pipeline Through the First Half of 2029 -

WAYNE, Pa., Nov. 05, 2026 (GLOBE NEWSWIRE) -- Aclaris Therapeutics, Inc. (NASDAQ: ACRS), a clinical-stage biopharmaceutical company focused on developing novel product candidates for immuno-inflammatory diseases, today announced its financial results for the third quarter of 2026 and provided a corporate and clinical update.

“Aclaris is developing unique product candidates designed to provide improved therapeutic options across a variety of inflammatory disorders with the goal of raising the efficacy ceiling, and our recent progress reflects continued execution toward that objective,” stated Dr. Neal Walker, Chief Executive Officer and Chair of the Board of Directors of Aclaris. “We recently announced strongly positive primary analysis results from our Phase 1b POC trials with ATI-052 in AD and asthma; we look forward to starting a Phase 2b trial in eosinophilic esophagitis early next year. Beyond that, we have a series of expected clinical and regulatory milestones throughout the rest of 2026 and 2027, including Phase 2 results in AD from bosakitug and the start of the Phase 2b trial of our oral ITK/JAK3 inhibitor modzatinib in lichen planus, both in the coming few weeks.”

Third Quarter 2026 Highlights, Recent Updates and Upcoming Catalysts

Pipeline:

Biologics: Antibody Franchise

• Positive Primary Analysis Results Demonstrated Rapid Improvement in Skin and Itch in Phase 1b POC Trial of Investigational Bispecific Anti-TSLP/IL-4Rα Antibody ATI-052 in Severe AD: Patients treated with ATI-052 experienced a 45% placebo-adjusted mean change in EASI score from baseline at week 8 with durable responses for the subset of patients with available data observed through week 16 (follow up ongoing) and a 78% placebo-adjusted EASI-50 at week 8. Patients who received ATI-052 experienced a 43% placebo-adjusted mean improvement in itch (PP-NRS) at week 8. ATI-052 was well tolerated and demonstrated a favorable safety profile. No conjunctivitis was observed. (press release here)
• Normalization of Lesional Skin Toward Baseline with ATI-052 Observed in Pharmacodynamic Results in AD: Marked normalization observed in the lesional skin proteome at week 8 in patients receiving ATI-052, with immune protein expression resembling that of non-lesional skin. ATI-052 induced a broad pathway downregulation, with modulation across multiple inflammatory pathways, Th1, Th2 and Th17/Th22, fibrosis/ECM remodeling, and itch-associated molecular pathways. (press release here)
• Positive Primary Analysis Results Showed Rapid Improvement in Airway Inflammation and Lung Function in Phase 1b POC Trials of ATI-052 in Asthma: Following a single dose of ATI-052, patients experienced a rapid 59% mean absolute reduction in fractional exhaled nitric oxide (FeNO) (45 ppb) only 15 days after administration and a 40% reduction at day 29. Patients receiving ATI-052 experienced a placebo adjusted and absolute 200 ml improvement in Forced Expiratory Volume in 1 Second (FEV1) at day 15. Safety and tolerability were consistent with that of the Phase 1b AD POC trial, including no observations of conjunctivitis. (press release here)
• Aclaris to Prioritize Development of ATI-052 in Eosinophilic Esophagitis (EoE): Consistent with its development strategy and capital management discipline, Aclaris intends to prioritize Phase 2b development of ATI-052 initially in EoE, where the Company believes ATI-052 is mechanistically well-matched. The Company expects to complete its assessment of an additional Phase 2b indication shortly, likely either AD or asthma.
• Readout of Top Line Results from Phase 2 Trial of Investigational Anti-TSLP Monoclonal Antibody Bosakitug Expected in the Fourth Quarter 2026: The randomized, double-blind, placebo-controlled Phase 2 ADMIRATION trial is evaluating the efficacy and safety of bosakitug in 109 patients with moderate-to-severe atopic dermatitis.
  

Kinase Inhibitors: ITK Franchise

• Initiation of Phase 2b Clinical Trial in Lichen Planus for Investigational Oral ITK/JAK3 Inhibitor Modzatinib Expected in the Fourth Quarter of 2026: Startup activities are ongoing with first site activation expected in November 2026 for this Phase 2b trial in lichen planus, an unaddressed chronic, inflammatory, CD8-driven interface dermatitis. There are currently no approved therapies in this indication.
• Filing of Investigational New Drug (IND) Application for Investigational Dual Inhibitor of ITK and TXK ATI-9494 On Track for Fourth Quarter 2026: ATI-9494 has demonstrated potent blockade of Th1 and Th2 responses, a prolonged half-life, and high potency against ITK, potentially enabling low drug burden, dosing flexibility, and once daily administration across a broad range of disease indications.

Financial Results

Liquidity and Capital Resources

As of September 30, 2026, Aclaris had cash, cash equivalents and marketable securities of $204.6 million compared to $151.4 million as of December 31, 2025. During October 2026, the Company sold 7.8 million shares of its common stock and issued pre-funded warrants to purchase 6.5 million shares of common stock for aggregate gross proceeds of $50.0 million, pursuant to the Company’s underwriting agreement with Leerink Partners LLC, Piper Sandler & Co. and Cantor Fitzgerald & Co.

Taking into account the net proceeds from the October offering, the Company believes that its cash, cash equivalents and marketable securities will be sufficient to fund its operations through the first half of 2029, without giving effect to any potential business development transactions or additional financing activities.

Third Quarter 2026 and Year-to-Date 2026

Net loss was $18.5 million for the third quarter of 2026 compared to $14.6 million for the third quarter of 2025. Net loss was $59.8 million for the nine months ended September 30, 2026 compared to $45.1 million for the nine months ended September 30, 2025.

Total revenue was $1.5 million for the third quarter of 2026 compared to $3.3 million for the third quarter of 2025. Total revenue was $5.1 million for the nine months ended September 30, 2026 compared to $6.5 million for the nine months ended September 30, 2025. The decreases were primarily driven by a sales milestone achieved under the Sun Pharma license agreement during the quarter and nine months ended September 30, 2025.

Research and development (R&D) expenses were $16.1 million and $49.8 million for the quarter and nine months ended September 30, 2026, respectively, compared to $13.0 million and $36.1 million for the corresponding prior year periods. The increases were primarily driven by expenses related to ATI-052, including product candidate manufacturing costs and clinical development expenses associated with Phase 1b programs in AD and asthma, as well as product candidate manufacturing costs and preclinical development expenses for ATI-9494.

General and administrative (G&A) expenses were $6.0 million and $18.8 million for the quarter and nine months ended September 30, 2026, respectively, compared to $4.9 million and $16.4 million for the prior year periods. The increases were primarily due to an increase in professional and legal expenses as well as personnel and stock-based compensation expenses.   

Revaluation of contingent consideration resulted in a $0.6 million gain for the quarter ended September 30, 2026 compared to a $0.1 million charge for the prior year period, primarily due to higher discount rates and changes in estimated sales levels during the quarter ended September 30, 2026. For the nine months ended September 30, 2026, revaluation of contingent consideration resulted in a $0.3 million gain compared to a $1.9 million charge for the prior year period, primarily due to changes to the probability of success for certain product candidates during the nine months ended September 30, 2025.

About Aclaris Therapeutics, Inc.

Aclaris Therapeutics, Inc. is a clinical-stage biopharmaceutical company developing a pipeline of novel product candidates to address the needs of patients with immuno-inflammatory diseases who lack satisfactory treatment options. The Company has a multi-stage portfolio of product candidates powered by a robust R&D engine. For additional information, please visit www.aclaristx.com and follow Aclaris on LinkedIn.

Cautionary Note Regarding Forward-Looking Statements

Any statements contained in this press release that do not describe historical facts may constitute forward-looking statements as that term is defined in the Private Securities Litigation Reform Act of 1995. These statements may be identified by words such as “anticipate,” “believe,” “expect,” “intend,” “may,” “plan,” “potential,” “will,” and similar expressions, and are based on Aclaris’ current beliefs and expectations. These forward-looking statements include expectations regarding its plans for its development programs for bosakitug (ATI-045), ATI-052, modzatinib (ATI-2138), and ATI-9494, including the timing of reporting top line results from its Phase 2 trial of bosakitug in AD, the clinical development plans for ATI-052 including its intention to prioritize EoE and the timing to initiate a Phase 2b trial in EoE, and the timing to initiate a Phase 2b trial in lichen planus with modzatinib, the timing to file an IND for ATI-9494, the potential of ATI-9494 to enable low drug burden, dosing flexibility, and once daily administration across a broad range of disease indications, the therapeutic potential of its product candidates including the potential for such candidates to be best-in-class, and the sufficiency of its cash, cash equivalents and marketable securities to fund its operations through the first half of 2029. These statements involve risks and uncertainties that could cause actual results to differ materially from those reflected in such statements. Risks and uncertainties that may cause actual results to differ materially include uncertainties inherent in the conduct of preclinical and clinical studies, risks associated with interim, top line and preliminary data, Aclaris’ reliance on third parties over which it may not always have full control, Aclaris’ ability to enter into strategic partnerships on commercially reasonable terms, the uncertainty regarding the macroeconomic environment and other risks and uncertainties that are described in the “Risk Factors” section of Aclaris’ Annual Report on Form 10-K for the year ended December 31, 2025, and other filings Aclaris makes with the U.S. Securities and Exchange Commission from time to time. These documents are available under the “SEC Filings” page of the “Investors” section of Aclaris’ website at www.aclaristx.com. Any forward-looking statements speak only as of the date of this press release and are based on information available to Aclaris as of the date of this release, and Aclaris assumes no obligation to, and does not intend to, update any forward-looking statements, whether as a result of new information, future events or otherwise.

Aclaris Therapeutics Contacts:

Kevin Balthaser
Chief Financial Officer
(484) 329-2178
kbalthaser@aclaristx.com

Will Roberts
Senior Vice President
Corporate Communications and Investor Relations
(484) 329-2125
wroberts@aclaristx.com

Aclaris Therapeutics, Inc. Condensed Consolidated Statements of Operations (unaudited, in thousands, except share and per share data)
	Three Months Ended								Nine Months Ended
	September 30,								September 30,
	2026				2025				2026				2025
Revenues:
Contract research	$	300			$	485			$	1,193			$	1,372
Licensing		1,181				2,814				3,913				5,159
Total revenue		1,481				3,299				5,106				6,531
Costs and expenses:
Cost of revenue(1)		189				538				802				1,559
Research and development(1)		16,066				13,028				49,789				36,061
General and administrative(1)		6,038				4,871				18,829				16,396
Licensing		1,132				1,911				3,760				4,256
Revaluation of contingent consideration		(600	)			100				(300	)			1,900
Total costs and expenses		22,825				20,448				72,880				60,172
Loss from operations		(21,344	)			(17,149	)			(67,774	)			(53,641	)
Other income:
Interest income		1,849				1,819				5,124				6,003
Non-cash royalty income		985				716				2,811				2,510
Total other income		2,834				2,535				7,935				8,513
Net loss	$	(18,510	)		$	(14,614	)		$	(59,839	)		$	(45,128	)
Net loss per share, basic and diluted	$	(0.12	)		$	(0.12	)		$	(0.43	)		$	(0.37	)
Weighted average common shares outstanding, basic and diluted		149,449,067				122,619,311				140,407,589				122,531,032
(1) Amounts include stock-based compensation expense as follows:
Cost of revenue	$	4			$	191			$	19			$	600
Research and development		979				964				2,925				3,255
General and administrative		2,036				1,705				5,945				5,603
Total stock-based compensation expense	$	3,019			$	2,860			$	8,889			$	9,458

Aclaris Therapeutics, Inc. Selected Consolidated Balance Sheet Data (unaudited, in thousands, except share data)
		September 30,			December 31,
		2026			2025
Cash, cash equivalents and marketable securities		$	204,607		$	151,363
Total assets		$	216,157		$	160,460
Total current liabilities		$	24,222		$	28,645
Total liabilities		$	49,358		$	57,378
Total stockholders' equity		$	166,799		$	103,082
Common stock outstanding			150,825,196			120,499,433

Aclaris Therapeutics, Inc. Selected Consolidated Cash Flow Data (unaudited, in thousands)
		Nine Months Ended
		September 30,
		2026				2025
Net loss		$	(59,839	)		$	(45,128	)
Depreciation and amortization			309				352
Stock-based compensation expense			8,889				9,458
Revaluation of contingent consideration			(300	)			1,900
Changes in operating assets and liabilities			(11,135	)			(564	)
Net cash used in operating activities		$	(62,076	)		$	(33,982	)

FAQ

AI-generated questions and answers. How Rhea-AI works. Not financial advice.

What were Aclaris Therapeutics' third-quarter 2026 financial results?

Aclaris reported $1.481 million in revenue and a $18.510 million net loss for third-quarter 2026. Revenue was $3.299 million and net loss was $14.614 million a year earlier. Basic and diluted loss per share remained $0.12.

How long does Aclaris expect its cash to fund operations?

Aclaris expects its cash, cash equivalents and marketable securities, including net proceeds from the October offering, to fund operations through the first half of 2029. That estimate excludes potential business development transactions or additional financing activities.

Why did Aclaris Therapeutics' revenue fall and research spending rise in 2026?

Aclaris attributes the revenue decline primarily to a Sun Pharma licensing sales milestone achieved in 2025, and higher research spending primarily to ATI-052 manufacturing and Phase 1b development, plus ATI-9494 manufacturing and preclinical work. These explanations apply to both the third-quarter and nine-month comparisons.