Abpro Holdings, Inc.

We believe that our current facilities are adequate for our current needs.

• We may not successfully engage in strategic transactions, including any additional collaborations we seek, which could adversely affect our ability to develop and commercialize product candidates, impact our cash position, increase our expenses, and present significant distractions to our management.
• We may acquire assets or form strategic alliances in the future, and we may not realize the benefits of such acquisitions.
• If third parties on which we intend to rely on to conduct certain pre-clinical studies, or any future clinical trials, do not perform as contractually required, fail to satisfy regulatory or legal requirements or miss expected deadlines, our development program could be delayed with material and adverse effects on our business, financial condition, results of operations and prospects.
• Because we may rely on third-party manufacturing and supply partners for pre-clinical and clinical development materials, our supply may become limited or interrupted or may not be of satisfactory quantity or quality.
• Our third-party manufacturers may be unable to successfully scale manufacturing of our product candidates in sufficient quality and quantity, which would delay or prevent us from developing our product candidates and commercializing approved products, if any.
• If the market opportunities for our product candidates are smaller than we believe they are, our future product revenues may be adversely affected and our business may suffer.
• We face competition from entities that have developed or may develop product candidates for the treatment of the diseases that we are initially targeting, including companies developing novel treatments and technology platforms. If these companies develop technologies or product candidates more rapidly than we do or their technologies are more effective, our ability to develop and successfully commercialize product candidates may be adversely affected.
• Any inability to attract and retain qualified key management, technical personnel and employees would impair our ability to implement our business plan.
• We may experience difficulties in managing our growth and expanding our operations.
• If any of our product candidates is approved for marketing and commercialization and we are unable to develop sales, marketing and distribution capabilities on our own or enter into agreements with third parties to perform these functions on acceptable terms, we will be unable to commercialize successfully any such future products.
• Our future growth may depend, in part, on our ability to operate in foreign markets, where we would be subject to additional regulatory burdens and other risks and uncertainties.
• Price controls imposed in foreign markets may adversely affect our future profitability.
• If any of our product candidates receives marketing approval and we or others later identify undesirable side effects caused by the product candidate, our ability to market and derive revenue from the product candidates could be compromised.
• Litigation and legal proceedings may substantially increase our costs and harm our business.
• Our business entails a significant risk of product liability and our ability to obtain sufficient insurance coverage could have a material and adverse effect on our business, financial condition, results of operations and prospects.
• Our employees, principal investigators, consultants and commercial partners, may engage in misconduct or other improper activities, including noncompliance with regulatory standards and requirements.
• Our internal computer systems, or those of CROs or other contractors or consultants we currently use or may use in the future, may fail or suffer security breaches, which could result in a material disruption of our product development programs.
• Our information technology systems could face serious disruptions that could adversely affect our business.
• If we do not comply with laws regulating the protection of the environment and health and human safety, our business could be adversely affected.
• We or the third parties upon whom we depend may be adversely affected by natural disasters and we may not be adequately protected from a serious disaster.
• Risks Related to our Intellectual Property
• If we are unable to obtain or protect intellectual property rights related to our technology and current or future product candidates, or if our intellectual property rights are inadequate, we may not be able to compete effectively.
• If we fail to comply with our obligations under any license, collaboration or other intellectual property related agreements, we may be required to pay damages and could lose intellectual property rights that are necessary for developing, commercializing and protecting our current or future technologies or product candidates or we could lose certain rights to grant sublicenses.
• Patent terms may be inadequate to protect our competitive position on our current or future technologies or product candidates for an adequate amount of time.
• Changes in U.S. patent law or the patent law of other countries or jurisdictions could diminish the value of patents in general, thereby impairing our ability to protect our current or any future technologies or product candidates.
• Other companies or organizations may challenge our or our licensors’ patent rights or may assert patent rights that prevent us from developing and commercializing our current or future products.
• We may not be able to protect our intellectual property rights throughout the world, which could negatively impact our business.
• Third parties may initiate legal proceedings alleging that we are infringing, misappropriating or violating their intellectual property rights, the outcome of which would be uncertain and could have a material adverse impact on the success of our business.
• Intellectual property rights of third parties could adversely affect our ability to commercialize our current or future technologies or product candidates, and we might be required to litigate or obtain licenses from third parties in order to develop or market our current or future technologies or product candidates, which may not be available on commercially reasonable terms or at all.
• If we are unable to protect the confidentiality of our trade secrets, our business and competitive position would be harmed.
• We may be subject to claims that we or our employees or consultants have wrongfully used or disclosed alleged trade secrets or other proprietary information of our employees’ or consultants’ former employers or their clients.
• Obtaining and maintaining our patent protection depends on compliance with various procedural, document submission, fee payment and other requirements imposed by government patent agencies, and our patent protection could be reduced or eliminated for non-compliance with these requirements.
• If our trademarks and trade names are not adequately protected, then we may not be able to build name recognition in our markets of interest, and our business may be adversely affected.
• Intellectual property rights do not necessarily address all potential threats to our business.
• Risks Related to Government Regulation
• Clinical development involves a lengthy and expensive process with an uncertain outcome, and results of earlier studies and trials may not be predictive of future trial results.
• We may be unable to obtain U.S. or foreign regulatory approval and, as a result, be unable to commercialize our product candidates, resulting in substantial harm to our business.
• We may in the future conduct clinical trials for current or future product candidates outside the United States, and the FDA and comparable foreign regulatory authorities may not accept data from such trials.
• Even if we receive regulatory approval for any of our product candidates, we will be subject to ongoing regulatory obligations and continued regulatory review, which may result in significant additional expense. Additionally, our product candidates, if approved, could be subject to labeling and other restrictions and market withdrawal and we may be subject to penalties if we fail to comply with regulatory requirements or experience unanticipated problems with our products.
• We may fail to obtain and maintain orphan drug designation from the FDA for our current and future product candidates, as applicable.
• Healthcare legislative reform measures may have a material adverse effect on our business and results of operations.
• If we or existing or future partners, manufacturers or service providers fail to comply with healthcare laws and regulations, we or they could be subject to enforcement actions, which could affect our ability to develop, market and sell our products and may harm our reputation.
• If we fail to comply with U.S. and foreign regulatory requirements, regulatory authorities could limit or withdraw any marketing or commercialization approvals we may receive and subject us to other penalties that could materially harm our business.
• Even if we are able to commercialize any product candidate, such product candidate may become subject to unfavorable pricing regulations or third-party coverage and reimbursement policies, which would harm our business.
• We are subject to U.S. and foreign anti-corruption and anti-money laundering laws with respect to our operations and non-compliance with such laws can subject us to criminal and/or civil liability and harm our business.
• Comprehensive tax reform bills could adversely affect our business and financial condition.
• Our ability to utilize our net operating loss carryforwards and certain other tax attributes may be limited.
• Risks Related to Our Organization and Structure
• Our Charter and the Bylaws provide that the Court of Chancery of the State of Delaware is the sole and exclusive forum for substantially all disputes between us and our stockholders, which could limit our stockholders’ ability to obtain a favorable judicial forum for disputes with us or our directors, officers, or employees.
• Anti-takeover provisions in our governing documents and under Delaware law could make an acquisition of us more difficult, limit attempts by our stockholders to replace or remove our current management and limit the market price of our Common Stock.
• Our management has limited experience in operating a U.S.-listed public company.
• We will incur significant increased expenses and administrative burdens as a public company, which could have an adverse effect on its business, financial condition and results of operations.
• In the prior years, we have identified material weakness in our internal control over financial reporting, which could affect our ability to ensure timely and reliable financial reports and weaken investor confidence in our financial reporting.
• Our disclosure controls and procedures may not prevent or detect all errors or acts of fraud.
• Changes in accounting rules and regulations, or interpretations thereof, could result in unfavorable accounting charges or require us to change our compensation policies.
• We will need to improve our operational and financial systems to support our expected growth, increasingly complex business arrangements, and rules governing revenue and expense recognition and any inability to do so will adversely affect our billing and reporting.
• We are an “emerging growth company,” and our reduced SEC reporting requirements may make our shares less attractive to investors.
• Risks Related to this Offering and Ownership of Our Common Stock
• Holders of our warrants will have no rights as a common stockholder until they acquire our common stock.
• Our failure to meet Nasdaq’s continued listing requirements could result in a delisting of our shares.
• Our Reverse Stock Split may decrease the liquidity of the shares of our Common Stock.
• Following a reverse stock split, the resulting market price of our Common Stock may not attract new investors, including institutional investors, and may not satisfy the investing requirements of those investors. Consequently, the trading liquidity of our Common Stock may not improve.
• The market price of our Common Stock may decline.
• If securities or industry analysts do not publish research or reports about our business or publish negative reports about our business, our share price and trading volume could decline.
• Our Common Stock price may decline and you could lose all or part of your investment as a result.
• Because there are no current plans to pay cash dividends on our Common Stock for the foreseeable future, you may not receive any return on investment unless you sell your Common Stock at a price greater than what you paid for it.
• Our shareholders may experience dilution in the future.
• Future sales, or the perception of future sales, by us or our shareholders in the public market could cause the market price for our Common Stock to decline.