Aclaris Therapeutics, Inc.

We believe that our facilities are suitable and adequate to meet our current needs.

• If we experience delays or difficulties in the enrollment of subjects in clinical trials, our ability to identify and consummate transactions with third-party partners to further develop, obtain marketing approval for and/or commercialize our product candidates could be delayed or prevented.
• Our clinical trials may fail to demonstrate the safety and efficacy of our product candidates, or serious adverse or unacceptable side effects or other unfavorable safety findings may be identified during the nonclinical or clinical development of our product candidates, which could increase our costs or necessitate the abandonment or limitation of the development of our product candidates or prevent or delay our ability identify and consummate transactions with third-party partners to further develop, obtain marketing approval for and/or commercialize our product candidates.
• Interim, topline and preliminary data from our clinical trials that we announce or publish from time to time may change as more subject data become available and are subject to audit and verification procedures that could result in material changes in the final data.
• Changes in methods of product candidate manufacturing or formulation may result in additional costs or delay.
• We have conducted and may in the future conduct clinical or nonclinical studies for our product candidates outside the United States. The FDA, EMA or comparable foreign regulatory authorities may not accept data from such studies.
• We may not be successful in our efforts to increase our pipeline of product candidates, including by in-licensing or acquiring additional product candidates.
• We may expend our limited resources to pursue a particular product candidate or indication and fail to capitalize on product candidates or indications that may be more profitable or for which there is a greater likelihood of success.
• For any of our product candidates that receive marketing approval, our potential third-party partners may fail to achieve the degree of market acceptance by physicians, patients, third-party payors and others in the medical community necessary for commercial success.
• We face substantial competition, which may result in others discovering, developing or commercializing drugs before or more successfully than we do.
• The success of our product candidates, if approved, will depend significantly on coverage and adequate reimbursement or the willingness of patients to pay for these products.
• Product liability lawsuits against us could cause us to incur substantial liabilities and to limit commercialization of any of our product candidates that we may develop and are commercialized by our potential third-party partners or impact any commercial products that we have previously sold or are being sold by third-party partners.
• Risks Related to Our Dependence on Third Parties
• We rely on third parties to conduct clinical trials for our product candidates, and those third parties may not perform satisfactorily, including failing to meet deadlines for the completion of such trials.
• We contract with third parties for the manufacture and supply of our product candidates for preclinical and clinical testing. This reliance on third parties increases the risk that we will not have sufficient quantities of our product candidates or such quantities at an acceptable cost, which could delay, prevent or impair our development efforts.
• We intend to identify and consummate transactions with third-party partners to further develop, obtain marketing approval for and/or commercialize our product candidates. If those arrangements are not successful, we may not be able to capitalize on the market potential of these product candidates.
• If we are not able to establish partnerships, we may have to alter our development and commercialization plans.
• We may not have access to all information regarding our product candidates that are subject to partnership agreements. Consequently, our ability to inform our stockholders about the status of our product candidates that are subject to these agreements, and our ability to make business and operational decisions, may be limited.
• We are dependent on third parties accurately generating and reporting data related to our product candidates, and their conduct could adversely affect our business.
• Risks Related to Our Intellectual Property
• If we are unable to obtain and maintain patent protection for our product candidates, or if the scope of the patent protection obtained is not sufficiently broad, our competitors could develop and commercialize technology and drugs similar or identical to ours, and ability to successfully identify a potential third-party partner to commercialize our technology and product candidates may be impaired.
• We may become involved in lawsuits to protect or enforce our patents or other intellectual property, which could be expensive, time-consuming and unsuccessful. Further, our issued patents could be found invalid or unenforceable if challenged in court.
• We may not be able to protect our intellectual property rights throughout the world.
• We may need to license intellectual property from third parties, and such licenses may not be available or may not be available on commercially reasonable terms.
• Third parties may initiate legal proceedings alleging that we are infringing their intellectual property rights, the outcome of which would be uncertain and could have a material adverse effect on the success of our business.
• We may be subject to claims by third parties asserting that we, our employees or our licensors have misappropriated their intellectual property, or claiming ownership of what we regard as our own intellectual property.
• Intellectual property litigation could cause us to spend substantial resources and distract our personnel from their normal responsibilities.
• If we are unable to protect the confidentiality of our trade secrets, our business and competitive position would be harmed.
• The validity, scope and enforceability of any of our patents that cover any of our product candidates can be challenged by competitors.
• If we do not obtain protection under the Hatch-Waxman Act by extending the patent term and obtaining data exclusivity for our product candidates, our business may be materially harmed.
• Any trademarks we have obtained or may obtain may be infringed or successfully challenged, resulting in harm to our business.
• Outside of the United States we cannot be certain that any country’s patent or trademark office will not implement new rules that could seriously affect how we draft, file, prosecute and maintain patents, trademarks and patent and trademark applications.
• Intellectual property rights do not necessarily address all potential threats to our competitive advantage.
• Risks Related to Regulatory Approval of Our Product Candidates and Other Legal Compliance Matters
• If our potential third-party partners are not able to obtain, or if there are delays in obtaining, required regulatory approvals, our product candidates will not be able to be commercialized, and our ability to earn revenue from arrangements with such third-party partners will be materially impaired.
• Failure to obtain marketing approval in international jurisdictions would prevent our product candidates from being marketed abroad.
• A variety of risks associated with marketing our product candidates by our potential third-party partners internationally could harm our business.
• Any product candidate for which our potential third-party partners obtain marketing approval could be subject to post-marketing restrictions or recall or withdrawal from the market, and our potential third-party partners may be subject to penalties if they fail to comply with regulatory requirements or if they experience unanticipated problems with our product candidates, when and if any of them are approved.
• Our and our potential third-party partners’ operations may subject us and such partners, directly or indirectly, to broadly applicable anti-kickback, fraud and abuse, false claims, physician payment transparency, health information privacy and security and other health care laws and regulations, and any failure to comply with such laws and regulations could have a material adverse effect on our profitability.
• Recently enacted and future legislation may increase the difficulty and cost for our potential third-party partners to obtain marketing approval of our product candidates and commercialize our product candidates, if approved, and affect the prices our potential third-party partners may obtain.
• Our biological product candidates may face competition sooner than anticipated.
• Governments outside the United States tend to impose strict price controls, which may adversely affect our revenue.
• If we fail to comply with environmental, health and safety laws and regulations, we could become subject to fines or penalties or incur costs that could harm our business.
• We are subject to governmental economic sanctions laws and export and import controls that could impair our potential third-party partners’ ability to compete in international markets or subject us or our potential third-party partners to liability if we or they are not in compliance with applicable laws.
• We and our potential third-party partners are subject to anti-corruption and anti-money laundering laws with respect to our and their operations and non-compliance with such laws can subject us to criminal and/or civil liability and harm our business.
• Risks Related to Employee Matters and Managing Our Growth
• Our future success depends on our ability to retain key executives and to attract, retain and motivate qualified personnel.
• Our employees, independent contractors, consultants, third-party partners, principal investigators, CROs and vendors may engage in misconduct or other improper activities, including non-compliance with regulatory standards and requirements.
• Risks Related to Ownership of Our Common Stock
• The trading price of the shares of our common stock has been and is likely to continue to be volatile.
• If we fail to maintain compliance with the listing requirements of the Nasdaq Global Select Market, we may be delisted and the price of our common stock and our ability to access the capital markets could be negatively impacted.
• Sales of a substantial number of shares of our common stock into the market could cause the market price of our common stock to drop significantly, even if our business is doing well.
• Provisions in our corporate charter documents and under Delaware law may prevent or frustrate attempts by our stockholders to change our management and hinder efforts to acquire a controlling interest in us, and the market price of our common stock may be lower as a result.
• If we fail to maintain proper and effective internal controls, our ability to produce accurate financial statements on a timely basis could be impaired.
• We might not be able to utilize a significant portion of our net operating loss carryforwards and research and development tax credit carryforwards.
• We do not anticipate paying any cash dividends on our common stock in the foreseeable future and our stock may not appreciate in value.
• Exclusive forum provisions in our amended and restated certificate of incorporation and amended and restated bylaws could limit our stockholders’ ability to obtain a favorable judicial forum for disputes with us or our directors, officers or other employees.
• Our holders of 5% or more of our capital stock collectively own a significant percentage of our outstanding common stock and have the ability to exert significant control over matters subject to stockholder approval.
• We are a “smaller reporting company” and, as a result of the reduced disclosure and governance requirements applicable to smaller reporting companies, our common stock may be less attractive to investors.
• General Risk Factors
• If our information technology systems or data, or those of the third parties with whom we work, are or were compromised, we could experience adverse consequences resulting from such compromise, including but not limited to regulatory investigations or actions; litigation; fines and penalties; disruptions of our business operations; reputational harm; loss of revenue or profits; and other adverse consequences.
• An active trading market for our common stock may not be sustained.
• If equity research analysts do not publish research or reports, or publish unfavorable research or reports, about us, our business or our market, our stock price and trading volume could decline.
• Unfavorable macroeconomic conditions, including tariff policies and inflationary pressure, as well as constrained capital markets, could limit our ability to grow our business, raise capital and negatively affect our operating results.
• The issuance of additional stock in connection with financings, acquisitions, investments, our equity incentive plan or otherwise will dilute all other stockholders.
• Changes in tax laws or regulations that are applied adversely to us may have a material adverse effect on our business, cash flow, financial condition or results of operations.
• We incur significant costs and demands upon management as a result of being a public company.
• Artificial intelligence presents risks and challenges that can impact our business including by posing security risks to our confidential information, proprietary information, and personal data, and may subject us to evolving regulatory requirements.