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Aclaris Therapeutics(ACRS) - 2024 Q3 - Quarterly Report

Financial Performance - The net loss for the nine months ended September 30, 2024, was 35.5million,andfortheyearendedDecember31,2023,itwas35.5 million, and for the year ended December 31, 2023, it was 88.5 million, with an accumulated deficit of 806.3millionasofSeptember30,2024[104].InthethreemonthsendedSeptember30,2024,totalrevenuedecreasedto806.3 million as of September 30, 2024[104]. - In the three months ended September 30, 2024, total revenue decreased to 4.346 million from 9.282millioninthesameperiodof2023,adeclineofapproximately53.19.282 million in the same period of 2023, a decline of approximately 53.1%[141]. - Licensing revenue recognized during the three months ended September 30, 2024, was 0.7 million, compared to 8.3millionforthesameperiodin2023[113].ThenetlossforthethreemonthsendedSeptember30,2024,was8.3 million for the same period in 2023[113]. - The net loss for the three months ended September 30, 2024, was (7.586) million, an improvement from (29.261)millioninthesameperiodof2023,reflectingadecreaseofapproximately74(29.261) million in the same period of 2023, reflecting a decrease of approximately 74%[141]. - The company anticipates incurring net losses in the near term as it continues to discover and develop drug candidates[171]. Research and Development - In September 2023, positive results from a Phase 1 trial of ATI-2138 showed it was well tolerated at all doses tested, with near maximal inhibition of biomarkers achieved at a 30 mg total daily dose[91]. - The Phase 2a trial of ATI-2138 for moderate to severe atopic dermatitis began in September 2024, with top-line data expected in the first half of 2025[94]. - The Phase 2b trial of lepzacitinib demonstrated a statistically significant EASI score improvement of 69.7% for the 2% BID group compared to 58.7% for the vehicle group (p=0.035)[96]. - The company discontinued the development of zunsemetinib for immuno-inflammatory diseases in 2023 following Phase 2 trial results[103]. - Total research and development expenses for the nine months ended September 30, 2024, were 24.6 million, a significant decrease of 47.2millioncomparedto47.2 million compared to 71.7 million in the same period of 2023[149]. Revenue and Expenses - Contract research revenue for the three months ended September 30, 2024, was 645thousand,downfrom645 thousand, down from 705 thousand in 2023, a decrease of about 8.5%[141]. - Licensing revenue fell to 3.701millioninthethreemonthsendedSeptember30,2024,comparedto3.701 million in the three months ended September 30, 2024, compared to 8.577 million in 2023, representing a decline of approximately 56.5%[141]. - General and administrative expenses decreased to 5.653millioninthethreemonthsendedSeptember30,2024,from5.653 million in the three months ended September 30, 2024, from 7.091 million in 2023, a decline of approximately 20.2%[141]. - Personnel expenses for general and administrative purposes decreased to 1.2millionforthethreemonthsendedSeptember30,2024,downfrom1.2 million for the three months ended September 30, 2024, down from 1.9 million in 2023, a reduction of approximately 37.1%[155]. - Professional and legal fees increased to 1.9millionforthethreemonthsendedSeptember30,2024,comparedto1.9 million for the three months ended September 30, 2024, compared to 1.0 million in 2023, reflecting an increase of about 77.5%[156]. Cash Flow and Capital - Cash and cash equivalents as of September 30, 2024, were 47.7million,anincreasefrom47.7 million, an increase from 39.9 million as of December 31, 2023[167]. - Net cash used in operating activities for the nine months ended September 30, 2024, was 11.1million,adecreasefrom11.1 million, a decrease from 71.6 million in the same period of 2023, indicating improved cash flow management[168]. - As of September 30, 2024, the company had cash, cash equivalents, and marketable securities totaling 173.4million[165].NetcashprovidedbyinvestingactivitiesfortheninemonthsendedSeptember30,2024,was173.4 million[165]. - Net cash provided by investing activities for the nine months ended September 30, 2024, was 18.954 million, a decrease from 38.670millionforthesameperiodin2023[169].NetcashusedinfinancingactivitiesfortheninemonthsendedSeptember30,2024,was38.670 million for the same period in 2023[169]. - Net cash used in financing activities for the nine months ended September 30, 2024, was 44 thousand, a significant decrease from net cash provided of 26.657millioninthesameperiodof2023[170].StrategicPartnershipsandAgreementsAroyaltypurchaseagreementwithOCMIPHealthcarePortfolioLPresultedinanupfrontpaymentof26.657 million in the same period of 2023[170]. Strategic Partnerships and Agreements - A royalty purchase agreement with OCM IP Healthcare Portfolio LP resulted in an upfront payment of 26.5 million, with potential additional payments of up to 5.0millionbasedonsalesmilestonesforOLUMIANTin2024[107].AnexclusivepatentlicenseagreementwithSunPharmaceuticalIndustries,Inc.includedanupfrontpaymentof5.0 million based on sales milestones for OLUMIANT in 2024[107]. - An exclusive patent license agreement with Sun Pharmaceutical Industries, Inc. included an upfront payment of 15.0 million, with additional milestone payments and royalties based on net sales[110]. - The company is seeking a global development and commercialization partner for lepzacitinib, excluding Greater China, where Pediatrix Therapeutics, Inc. has exclusive rights[97]. Operational Changes - The company approved a workforce reduction of approximately 46% in December 2023 to streamline operations and reduce costs[117]. - The company recognized a severance expense of 26thousandforthethreemonthsendedSeptember30,2024,and26 thousand for the three months ended September 30, 2024, and 2.6 million for the nine months ended September 30, 2024[118]. - During the nine months ended September 30, 2024, the company recorded a charge to the contingent consideration liability of $3.8 million due to changes in estimated sales levels and probability of success for certain drug candidates[138]. Market and Economic Conditions - The company does not expect an immediate 10% change in market interest rates to materially affect the fair market value of its investment portfolio[182]. - Inflation has not had a material effect on the company's business, financial condition, or results of operations during the nine months ended September 30, 2024[184].