UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
FORM
CURRENT REPORT
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Indicate by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (§230.405 of this chapter) or Rule 12b-2 of the Securities Exchange Act of 1934 (§240.12b-2 of this chapter).
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Item 2.02 Results of Operations and Financial Condition.
On January 16, 2024, Aclaris Therapeutics, Inc. (the “Company”) issued a press release announcing, among other things, its preliminary unaudited aggregate cash, cash equivalents and marketable securities as of December 31, 2023. A copy of this press release is furnished herewith as Exhibit 99.1 to this Current Report.
In accordance with General Instruction B.2. of Form 8-K, the information in this Item 2.02 and Exhibit 99.1 hereto shall not be deemed “filed” for purposes of Section 18 of the Securities Exchange Act of 1934, as amended (the “Exchange Act”), or otherwise subject to the liability of that section, nor shall it be deemed incorporated by reference in any of the Company’s filings under the Securities Act of 1933, as amended (the “Securities Act”), or the Exchange Act, whether made before or after the date hereof, regardless of any incorporation language in such a filing, except as expressly set forth by specific reference in such a filing.
Item 5.02 Departure of Directors or Certain Officers; Election of Directors; Appointment of Certain Officers; Compensatory Arrangements of Certain Officers.
(b)Departure of Douglas Manion as Chief Executive Officer and President and Director
On January 15, 2024, the Company and Douglas Manion mutually agreed that Dr. Manion will step down as the Company’s Chief Executive Officer and President and resign from the Board of Directors (the “Board”), effective January 16, 2024. Dr. Manion’s resignation from the Board was not the result of any disagreement with the Company on any matter relating to the Company’s operations, policies or practices.
(c) Appointment of Neal Walker as Interim Chief Executive Officer and President
In connection with the departure of Dr. Manion, on January 15, 2024, the Board appointed Neal Walker as the Company’s Interim Chief Executive Officer and President, effective January 17, 2024. Dr. Walker will continue to serve as the Chair of the Board. Biographical information about Dr. Walker is contained in the Company’s Definitive Proxy Statement for the Company’s 2023 Annual Meeting of Stockholders filed with the Securities and Exchange Commission on April 20, 2023 under the caption “Election of Directors” and is incorporated herein by reference. Effective January 17, 2024, Dr. Walker will no longer be eligible to receive compensation under the Company’s non-employee director compensation policy.
There are no arrangements or understandings between Dr. Walker and any other person pursuant to which he was selected as an officer of the Company, and there is no family relationship between Dr. Walker and any of the Company’s other directors or executive officers. There are no related party transactions between Dr. Walker and the Company that would require disclosure under Item 404(a) of Regulation S-K.
Dr. Walker has previously entered into the Company’s standard form of indemnification agreement. The Company also anticipates entering into an agreement with Dr. Walker setting forth the terms of his compensation as the Company’s Interim Chief Executive Officer.
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Item 9.01 Financial Statements and Exhibits.
(d) Exhibits
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99.1 | ||
104 | Cover Page Interactive Data File (embedded within the Inline XBRL document). |
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SIGNATURES
Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.
ACLARIS THERAPEUTICS, INC. | ||
By: | /s/ Kevin Balthaser | |
Date: January 19, 2024 | Kevin Balthaser | |
Chief Financial Officer |
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Exhibit 99.1
Aclaris Therapeutics Announces Leadership Changes and Strategic Business Review
– | Douglas Manion, M.D. to step down as Chief Executive Officer, President and Member of Board of Directors – |
– | Dr. Neal Walker, Current Chairman and Co-founder, Appointed as Interim Chief Executive Officer – |
WAYNE, Pa., Jan. 16, 2024 (GLOBE NEWSWIRE) -- Aclaris Therapeutics, Inc. (NASDAQ: ACRS), a clinical-stage biopharmaceutical company focused on developing novel drug candidates for immuno-inflammatory diseases, today announced leadership changes and that it is undertaking a strategic review of its business.
Aclaris and Douglas Manion, M.D. have mutually agreed that Dr. Manion will step down as Aclaris’ Chief Executive Officer and President and member of the Board of Directors, effective immediately. In connection with his departure, the Board has appointed Dr. Neal Walker, Aclaris’ Chairman of the Board of Directors, as Interim Chief Executive Officer. Dr. Walker is a co-founder of Aclaris, has served as a member of the Board of Directors since its inception, and previously served as Aclaris’ Chief Executive Officer until 2022.
“Doug joined our company as we were actively heading into later stage development,” said Dr. Walker. “As the Company looks to reset in 2024, we agreed that the timing was right for this transition. On behalf of the company, I thank Doug for his many contributions to our company and we wish him the best in his future endeavors.”
Dr. Manion commented, “It has been a privilege to have been part of Aclaris Therapeutics and I am proud of the work our amazing team conducted to further scientific research.”
Concurrent with today’s announcement, Aclaris also announced that it is conducting a strategic review of its business to determine how to optimally deploy its capital to maximize shareholder return. On a preliminary unaudited basis, as of December 31, 2023, Aclaris’ aggregate cash, cash equivalents and marketable securities was approximately $182 million.
Aclaris also reiterates the following business plans:
| ● | ATI-1777: Aclaris is seeking a development and commercialization partner for ATI-1777, its investigational topical “soft” JAK 1/3 inhibitor. Aclaris recently reported positive top-line results from its Phase 2b trial in atopic dermatitis. |
| ● | ATI-2138: Aclaris is assessing the most effective pathway including the lead indication for ATI-2138, its Phase 2 ready investigational oral covalent ITK/JAK3 inhibitor. Aclaris announced positive results from its Phase 1 MAD trial of ATI-2138 in 2023. |
| ● | Discovery: Aclaris plans to continue to advance discovery programs through KINect®, its proprietary drug discovery platform. |
“Throughout our history, Aclaris has remained focused on developing novel drugs where there is a lack of satisfactory treatment options,” said Dr. Walker. “We are well capitalized and we have recently taken the hard but necessary steps to streamline our operations to reduce costs and preserve capital in order to put Aclaris in an optimal position for the future.”
Aclaris has not established a timeline for the completion of its strategic review and does not intend to comment further unless and until its Board of Directors has approved a definitive course of action, or it is determined that other disclosure is necessary or appropriate.
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,” “anticipate,” “expect,” “intend,” “may,” “plan,” “potential,” “will,” and similar expressions, and are based on Aclaris’ current beliefs and expectations. These forward-looking statements include Aclaris’ expectations regarding its development plans for its clinical and discovery programs, its plans to seek a development and commercialization partner for ATI-1777, its plans to undertake a strategic review of its business, and its aggregate cash, cash equivalents and marketable securities as of December 31, 2023. 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 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, 2022 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.
The preliminary, unaudited financial information set forth in this press release is subject to the completion of Aclaris’ audit process and is subject to change. The estimated preliminary results included in this press release should not be viewed as a substitute for Aclaris’ annual financial statements prepared in accordance with U.S. generally accepted accounting principles. There can be no assurance that the estimated preliminary results will be realized, and you are cautioned not to place undue reliance on the preliminary financial information, which reflects management’s current expectations and anticipated results of operations, which are subject to known and unknown risks, uncertainties and other factors that may cause Aclaris’ actual results to differ materially from the information presented herein.
Aclaris Therapeutics Contact:
investors@aclaristx.com
