 First Subject Dosed in Phase 2a Trial of ATI-450, an Investigational Oral MK2 Inhibitor, as a Potential Treatment for Moderate to Severe Rheumatoid Arthritis First Subject Dosed in Phase 2a Trial of ATI-450 for Cytokine Release Syndrome in Hospitalized Patients with COVID-19 Clinical Trial of ATI-1777, an Investigational Soft Topical JAK 13 Inhibitor, to Proceed in Patients with Moderate to Severe Atopic Dermatitis WAYNE, Pa., Aug. 07, 2020 GLOBE NEWSWIRE -- Aclaris Therapeutics, Inc. NASDAQ: ACRS, a clinical-stage biopharmaceutical company focused on developing novel drug candidates for immuno-inflammatory diseases, today announced its financial results for the second quarter of 2020 and provided research and development RD and business highlights.As the pandemic evolves, our team has continued to work hard to make the appropriate business adjustments, advance our pipeline and execute through these uncertain times, said Dr. Neal Walker, President and CEO of Aclaris. In the second quarter, we dosed the first subject in our Phase 2a trial of ATI-450 as a potential treatment for moderate to severe rheumatoid arthritis. We are also proud to be participating in the effort to find effective therapeutics for COVID-19 by supporting an investigator-initiated clinical trial of ATI-450 for cytokine release syndrome in hospitalized patients with COVID-19 and the first subject has been dosed in this trial. In addition, we are progressing with the first-in-human trial of ATI-1777 in patients with moderate to severe atopic dermatitis. We look forward to continuing to execute on our clinical development plans.RD Highlights: The global outbreak of COVID-19 continues to rapidly evolve and has caused and may continue to cause Aclaris to experience disruptions that could impact the timing of its regulatory and research and development activities listed below. ATI-450, an investigational oral small molecule MK2 inhibitor compound: ATI-450-RA-201: An ongoing Phase 2a trial to investigate the safety, tolerability, pharmacokinetics and pharmacodynamics of ATI-450 in subjects with moderate to severe rheumatoid arthritis. This trial was initiated in March 2020. Due to the COVID-19 pandemic, Aclaris temporarily paused enrollment. Aclaris resumed enrolling subjects, and the first subject was dosed, in May 2020. At this time, Aclaris is actively recruiting for this trial. Given the continuing evolution of the COVID-19 pandemic, Aclaris now anticipates reporting data from this trial in the first half of 2021. ATI-450-CAPS-201: Aclaris expects to initiate a Phase 2a clinical trial of ATI-450 in cryopyrin-associated periodic syndrome CAPS, an IL1β-driven disease, in the second half of 2020. IIT-2020-ATI-450-COVID-19: An ongoing investigator-initiated Phase 2a, randomized, double-blind, placebo-controlled clinical trial to investigate the safety and efficacy of ATI-450, when used in addition to standard of care therapy, as a potential treatment for cytokine release syndrome in 36 hospitalized patients with COVID-19. Aclaris is providing funding and clinical drug supply to the University of Kansas Medical Center KUMC, the sponsor of the trial. The primary endpoint in this trial is the proportion of subjects who are free from respiratory failure by day 14. The first subject was dosed in August 2020. ATI-1777, an investigational topical soft Janus Kinase JAK 13 inhibitor compound: Aclaris submitted an Investigational New Drug IND Application for ATI-1777 for the treatment of moderate to severe atopic dermatitis AD in June 2020 and now plans to progress to the first-in-human trial of ATI-1777 in subjects with moderate to severe AD. ATI-1777-AD-201: Aclaris expects to initiate a Phase 12a multicenter, randomized, double-blind, vehicle-controlled trial to investigate the safety, tolerability, pharmacokinetics and efficacy of topically applied ATI-1777 in subjects with moderate to severe AD in the second half of 2020. The primary endpoint will assess efficacy at four weeks. ATI-2138, an investigational oral ITKTXKJAK3 ITJ inhibitor compound: Aclaris is developing ATI-2138 as a potential treatment for psoriasis andor inflammatory bowel disease and expects to submit an IND for ATI-2138 in 2021.Business Development Highlights: Aclaris continues to pursue strategic alternatives, including seeking partners for: A-101 45 Topical Solution: to obtain regulatory approval and commercialize A-101 45 Topical Solution, an investigational compound, as a potential treatment for common warts verruca vulgaris; ATI-501 ATI-502: to further develop, obtain regulatory approval and commercialize ATI-501 oral and ATI-502 topical, investigational JAK 13 inhibitor compounds, as potential treatments for alopecia; and ESKATA: to commercialize ESKATA hydrogen peroxide topical solution, 40 ww.Financial Highlights:Liquidity and Capital ResourcesAs of June 30, 2020, Aclaris had aggregate cash, cash equivalents and marketable securities of 68.1 million compared to 75.0 million as of December 31, 2019. For the quarter and six months ended June 30, 2020, net cash used in operating activities was 10.8 million and 17.6 million, respectively. As of June 30, 2020, Aclaris had approximately 42.7 million shares of common stock outstanding.Aclaris anticipates that its cash, cash equivalents and marketable securities as of June 30, 2020 will be sufficient to fund its operations through the first quarter of 2022, without giving effect to any potential business development transactions or financing activities.Second Quarter 2020 and Year-to-Date Financial Results The accompanying consolidated statements of operations and selected consolidated balance sheet data have been recast for all periods presented to reflect the assets, liabilities, revenue and expenses related to Aclaris commercial products as discontinued operations. Net loss was 11.6 million for the second quarter of 2020, compared to 49.9 million for the second quarter of 2019, and was 27.2 million for the six months ended June 30, 2020, compared to 87.4 million for the six months ended June 30, 2019. Total costs and expenses from continuing operations for the second quarter of 2020 were 13.4 million, compared to 44.5 million for the second quarter of 2019, and were 30.3 million for the six months ended June 30, 2020, compared to 72.8 million for the six months ended June 30, 2019. Total costs and expenses in the second quarter of 2020 included non-cash stock-based compensation expense of 3.3 million, compared to 4.6 million in the prior year period. Total costs and expenses for the six months ended June 30, 2020 included non-cash stock-based compensation expense of 6.8 million, compared to 8.9 million in the prior year period. Recorded a non-cash goodwill impairment charge of 18.5 million for the quarter and six months ended June 30, 2019. There were no impairment charges in either period in 2020. RD expenses were 6.5 million and 15.9 million for the quarter and six months ended June 30, 2020, respectively, compared to 17.5 million and 37.2 million for the quarter and six months ended June 30, 2019, respectively. The quarter-over-quarter decrease of 11.1 million was primarily the result of the substantial completion of Aclaris various Phase 2 clinical trials of ATI-501 and ATI-502 and two pivotal Phase 3 clinical trials of A-101 45 Topical Solution in 2019, and the corresponding reduction in personnel costs to support these programs. General and administrative expenses were 5.6 million and 11.8 million for the quarter and six months ended June 30, 2020, respectively, compared to 7.5 million and 14.9 million for the quarter and six months ended June 30, 2019, respectively. The quarter-over-quarter decrease of 1.9 million was primarily the result of lower personnel costs resulting from the Companys decision to discontinue commercial operations in September 2019. Loss from continuing operations was 11.6 million and 26.9 million for the quarter and six months ended June 30, 2020, respectively, compared to 43.7 million and 71.0 million for the quarter and six months ended June 30, 2019, respectively. Loss from discontinued operations was 27,000 and 0.3 million for the quarter and six months ended June 30, 2020, respectively, compared to 6.2 million and 16.5 million for the quarter and six months ended June 30, 2019, respectively.About Aclaris Therapeutics, Inc.Aclaris Therapeutics, Inc. is a clinical-stage biopharmaceutical company developing a pipeline of novel drug candidates to address the needs of patients with immuno-inflammatory diseases who lack satisfactory treatment options. The company has a multi-stage portfolio of drug candidates powered by a robust RD engine exploring protein kinase regulation. For additional information, please visit and follow Aclaris on LinkedIn or Twitter aclaristx.Cautionary Note Regarding Forward-Looking StatementsAny 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 believe, expect, intend, may, plan, potential, will, and similar expressions, and are based on Aclaris current beliefs and expectations. 