Earnings release
Page 1
aclaris THERAPEUTICS Exhibit 99.1 Aclaris Therapeutics Reports Second Quarter 2026 Financial Results and Provides Corporate and Clinical Update - Full Top Line Results from Phase 1a SAD / MAD Trial of ATI - 052 Validate Potential Best - in - Class Potency Advantage and Opportunity for E tended Dosing - - Timelines Reaffirmed for Upcoming Top Line Results from Phase 1b Proof - of - Concept ( Trials of ATI - 052 and Phase 2 Trial of Bosakitug ( - Strong Cash Runway E ATI - 045 ) - POC ) pected to Enable Development of Pipeline Through the End of 2028 - NASDAQ ACRS ) , a clinical - stage WAYNE , Pa . , August 6 , 2026 -- Aclaris Therapeutics , Inc. ( biopharmaceutical company focused on developing novel product candidates for immuno - inflammatory diseases , today announced its financial results for the second quarter of 202 and provided a corporate and clinical update . " The first half of 202 was a period of strong e positioning Aclaris for an e e I ecutive pect to provide three ecution across the organization , citing second half of the year with numerous pected key catalysts , " stated Dr. Neal Walker , Chief E Officer and Chair of the Board of Directors of Aclaris . " We e clinical data readouts , including placebo - controlled top line results from our two Phase 1b POC trials of our anti - TSLP / IL - 4Ra bispecific antibody ATI - 052 in both asthma and atopic dermatitis and the Phase 2 AD trial of our anti - TSLP monoclonal antibody bosakitug . Other key catalysts include initiation of a Phase 2b clinical program with ATI - 052 and a Phase 2b trial in lichen planus with modzatinib . Finally , our data presented recently at the FASEB Immunoreceptors and Immunotherapy conference support the best - in - class potential of our investigational ITK inhibitor ATI - 9494 , for which we e pect to file an IND late this year . " Second Quarter 2026 Highlights , Recent Updates and Upcoming Catalysts Pipeline : Biologics : Antibody Franchise Provided Positive Full TopLine Results of Phase 1a Single SAD ) and Multiple Ascending Dose MAD ) Trial of Investigational Bispecific Anti - TSLP / IL - 4Ra Antibody ATI - 052 Validating Potency and Potential for Extended Dosing ATI - 052 was well tolerated and demonstrated a favorable safety profile . The combination of the strong and sustained PK duration and PD effect supported the potential for to quarterly dosing . ( up press release here ) Reaffirmed Expectation of TopLine Results in the Second Half of 2026 from Two Ongoing Phase 1b POC Trials of ATI - 052 : ATI - 052 is being assessed in POC trials in both atopic dermatitis ) AD ) and asthma . Confirmed Intent to Initiate a Phase 2b Program Encompassing Asthma and AD with ATI - 052 in the Fourth Quarter of 2026 : Aclaris e pects the clinical program to commence with a Phase 2b trial in asthma in the fourth quarter of 202 The Company also now pects to commence startup activities for a Phase 2b trial in AD and for a EOE ) . e proof - of - concept ( POC ) trial in eosinophilic esophagitis ( On Track for Expected Fourth Quarter 2026 Readout of TopLine Results from Phase 2 Trial of Investigational Anti - TSLP Monoclonal Antibody Bosakitug : Enrollment is complete in this
Page 2
1 randomized, double-blind, placebo-controlled Phase 2 trial designed to evaluate bosakitug in 109 patients with AD. ( press release here)
Page 3
2 Kinase Inhibitors: ITK Franchise ● Initiation of Phase 2b Clinical Program for Modzatinib ATI-2138), a Potent and Selective Investigational Inhibitor of ITK and JAK3, Planned for the Fourth Quarter of 2026: Aclaris intends to initiate a multi-part Phase 2b trial of modzatinib in lichen planus, an unaddressed chronic, inflammatory, CD8-driven interface dermatitis. There are currently no approved therapies in this indication. ( press release here) ● On Track for Expected Fourth Quarter 2026 Filing of Investigational New Drug (IND) Application for ATI-9494, Aclaris’ Investigational Dual Inhibitor of ITK and TXK: 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 ( QD) administration across a broad range of disease indications. ● Presented Data Characterizing Potency, Selectivity, and Target Occupancy of ATI-9494: New preclinical data presented at the 2026 Federation of American Societies for Experimental Biology ( FASEB) Immunoreceptors and Immunology Science Research Conference included results from cellular target engagement studies that demonstrated potent engagement of ITK by ATI-9494 and its ability to block functional activation of the TCR pathway. ATI-9494 demonstrated potency up to 25 times greater than soquelitinib ( CPI-818) across multiple biochemical and functional cellular assays. Financial Results Liquidity and Capital Resources As of June 30, 2026 , Aclaris had cash, cash equivalents and marketable securities of $170.6 million compared to $151.4 million as of December 31, 2025. Subsequent to June 30, 2026 , the Company sold 7.3 million shares of its common stock for aggregate gross proceeds of $40.2 million, pursuant to the Company’s at-the-market ( ATM) agreement with Leerink Partners LLC and Cantor Fitzgerald & Co. Proceeds from these sales provide the Company with additional funds to support the planned commencement of startup activities for the Phase 2b trial of ATI-052 in AD and a POC trial in EoE. The Company believes that its cash, cash equivalents and marketable securities will be sufficient to fund its operations through the end of 2028, without giving effect to any potential business development transactions or additional financing activities. Second Quarter 2026 and Year-to-Date 2026 Net loss was $21.5 million for the second quarter of 2026 compared to $15.4 million for the second quarter of 2025. Net loss was $41.3 million for the six months ended June 30, 2026 compared to $30.5 million for the six months ended June 30, 2025. Total revenue was $1.6 million for the second quarter of 2026 compared to $1.8 million for the second quarter of 2025. Total revenue was $3.6 million for the six months ended June 30, 2026 compared to $3.2 million for the six months ended June 30, 2025. The increase for the six-month period was primarily driven by higher royalties earned under the Lilly and Sun Pharma license agreements. Research and development ( R&D) expenses were $18.1 million and $33.7 million for the quarter and six months ended June 30, 2026 , respectively, compared to $11.4 million and $23.0 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 a Phase 1a program and Phase 1b programs in AD and asthma, as well as product candidate manufacturing costs for ATI-9494. x
Page 4
3 General and administrative ( G&A) e penses were $6 .0 million and $12.8 million for the quarter and six months ended June 30, 2026 , respectively, compared to $5.4 million and $11.5 million for the prior year periods. The increases were primarily due to an increase in professional and legal expenses as well as personnel expenses. Revaluation of contingent consideration resulted in a $0.3 million charge for each of the quarter and six months ended June 30, 2026 compared to charges of $1.5 million and $1.8 million for the prior year periods. The decreases were primarily due to changes to the probability of success for certain product candidates and lower discount rates being applied to potential payments during the quarter and six months ended June 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-052, modzatinib ( ATI-2138), and ATI-9494, including the timing of reporting top line results from its Phase 2 trial of bosakitug in AD and its Phase 1b trials of ATI-052 in asthma and AD, the clinical development plans for ATI-052 including the timing of initiating a Phase 2b trial in asthma, the timing of initiating a Phase 2b trial in lichen planus with modzatinib, the timing to file an IND for ATI-9494, the potential for ATI-052 to have extended dosing, the therapeutic potential of its product candidates and 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 end of 2028. 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, 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
Page 6
4 Aclaris Therapeutics, Inc. Condensed Consolidated Statements of Operations ( unaudited, in thousands, except share and per share data) Three Months Ended Six Months Ended June 30, June 30, 2026 2025 2026 2025 Revenues: Contract research $ 356 $ 442 $ 893 $ 887 Licensing 1,273 1,335 2,732 2,345 Total revenue 1,6 29 1,777 3,6 25 3,232 Costs and expenses: Cost of revenue( 1) 218 515 6 13 1,021 Research and development( 1) 18,066 11,449 33,723 23,033 General and administrative( 1) 6 ,048 5,386 12,791 11,525 Licensing 1,235 1,335 2,6 28 2,345 Revaluation of contingent consideration 300 1,500 300 1,800 Total costs and expenses 25,867 20,185 50,055 39,724 Loss from operations ( 24,238) ( 18,408) ( 46 ,430) ( 36 ,492) Other income: Interest income 1,76 1 2,018 3,275 4,184 Non-cash royalty income 972 96 1 1,826 1,794 Total other income 2,733 2,979 5,101 5,978 Net loss $ ( 21,505)$ ( 15,429)$ ( 41,329)$ ( 30,514) Net loss per share, basic and diluted $ ( 0.15) $ ( 0.13)$ ( 0.30) $ ( 0.25) Weighted average common shares outstanding, basic and diluted 142,736,848 122,580,967 135,811,921 122,486 ,16 2 (1) Amounts include stock-based compensation expense as follows: Cost of revenue $ ( 13) $ 190$ 15 $ 409 Research and development 784 1,106 1,946 2,291 General and administrative 1,901 1,76 7 3,909 3,898 Total stock-based compensation expense $ 2,6 72 $ 3,06 3 $ 5,870 $ 6 ,598
Page 7
5 Aclaris Therapeutics, Inc. Selected Consolidated Balance Sheet Data ( unaudited, in thousands, except share data) June 30, December 31, 2026 2025 Cash, cash equivalents and marketable securities $ 170,621 $ 151,363 Total assets $ 179,693 $ 16 0,46 0 Total current liabilities $ 28,241 $ 28,6 45 Total liabilities $ 55,112 $ 57,378 Total stockholders' equity $ 124,581 $ 103,082 Common stock outstanding 139,824,273 120,499,433
Page 8
6 Aclaris Therapeutics, Inc. Selected Consolidated Cash Flow Data ( unaudited, in thousands) Six Months Ended June 30, 2026 2025 Net loss $ ( 41,329) $ ( 30,514) Depreciation and amortization 209 242 Stock-based compensation expense 5,870 6 ,598 Revaluation of contingent consideration 300 1,800 Changes in operating assets and liabilities ( 3,046 ) ( 1,176) Net cash used in operating activities $ ( 37,996) $ ( 23,050)