Aclaris Therapeutics Reports Third Quarter 2022 Financial Results and Provides a Corporate Update

“The third quarter of this year marked another period of important milestone achievement - the successful completion of enrollment in the Phase 2a trial of zunsemetinib in hidradenitis suppurativa,” said Dr. Neal Walker, Chief Executive Officer of Aclaris. “We also recently successfully completed the Phase 1 SAD trial for ATI-2138. We are very pleased with the results from the Phase 1 SAD trial which we believe support us proceeding to a multiple ascending dose (MAD) trial. Additionally, we have selected ulcerative colitis as the first target indication for ATI-2138 given the compelling pre-clinical profile and high medical need that persists for this debilitating disease.”

Research and Development Highlights:

Clinical Programs

Preclinical Programs

Financial Highlights:

Liquidity and Capital Resources

As of September 30, 2022, Aclaris had aggregate cash, cash equivalents and marketable securities of $248.1 million compared to $225.7 million as of December 31, 2021. Aggregate cash, cash equivalents and marketable securities as of September 30, 2022 included proceeds received during the quarter under a non-exclusive patent license agreement with Eli Lilly and Company (Lilly). Under the non-exclusive patent license agreement, Aclaris granted Lilly non-exclusive rights under certain patents and patent applications for the use of baricitinib, Lilly’s JAK inhibitor, to treat alopecia areata. Aclaris exclusively licenses patents and patents applications from a third party relating to the use of JAK inhibitors to induce hair growth and treat hair loss disorders.

Aclaris continues to anticipate that its cash, cash equivalents and marketable securities as of September 30, 2022 will be sufficient to fund its operations through the end of 2025, without giving effect to any potential business development transactions or financing activities.

Financial Results

Third Quarter 2022

Year-to-date 2022

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 R&D engine exploring protein kinase regulation. For additional information, please visit www.aclaristx.com.

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 “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 the development of Aclaris’ drug candidates, including the timing of its clinical trials, availability of data from those trials, and regulatory filings, and its belief that its existing cash, cash equivalents and marketable securities will be sufficient to fund its operations through the end of 2025. 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 clinical trials, 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 COVID-19 pandemic 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, 2021, 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, 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, 2022 2021 2022 2021Revenues: Contract research $1,090 $1,415 $3,529 $4,556Licensing 17,898 214 18,378 612Other 30 30 92 92Total revenue 19,018 1,659 21,999 5,260 Costs and expenses: Cost of revenue(1) 923 1,099 3,146 3,564Research and development(1) 23,656 13,976 56,741 29,711General and administrative(1) 5,813 5,979 17,987 16,676Licensing 7,300 — 7,300 —Revaluation of contingent consideration 2,200 900 (2,400) 22,139Total costs and expenses 39,892 21,954 82,774 72,090Loss from operations (20,874) (20,295) (60,775) (66,830)Other income (expense), net 922 (851) 1,502 (1,231)Net loss $(19,952) $(21,146) $(59,273) $(68,061)Net loss per share, basic and diluted $(0.30) $(0.35) $(0.92) $(1.23)Weighted average common shares outstanding, basic and diluted 66,675,337 61,219,321 64,718,008 55,215,037 (1) Amounts include stock-based compensation expense as follows: Cost of revenue $307 $206 $837 $787Research and development 1,400 939 2,228 2,969General and administrative 2,481 2,557 7,161 6,453Total stock-based compensation expense $4,188 $3,702 $10,226 $10,209 Aclaris Therapeutics, Inc.
Selected Consolidated Balance Sheet Data
(unaudited, in thousands, except share data) September 30, 2022 December 31, 2021 Cash, cash equivalents and marketable securities $248,062 $225,656Total assets $267,632 $251,211Total current liabilities $19,789 $22,931Total liabilities $47,794 $53,870Total stockholders' equity $219,838 $197,341Common stock outstanding 66,679,641 61,228,446 Aclaris Therapeutics, Inc.
Selected Consolidated Cash Flow Data
(unaudited, in thousands)

Nine Months Ended September 30, 2022 Nine Months Ended September 30, 2021 Net loss $(59,273) $(68,061)Depreciation and amortization 607 726Stock-based compensation expense 10,226 10,209Revaluation of contingent consideration (2,400) 22,139Loss on extinguishment of debt — 752Changes in operating assets and liabilities 2,388 (824)Net cash used in operating activities $(48,452) $(35,059)       

Aclaris Therapeutics Contact:

Robert A. Doody Jr.
Vice President, Investor Relations
484-639-7235
rdoody@aclaristx.com