BRAINSTORM CELL THERAPEUTICS INC.

We believe that the current office, laboratory space are adequate to meet our needs for research and development and administrative operations.

• We may not be able to secure and maintain research institutions to conduct our clinical trials.
• Risks Related to Our Business Operations and Commercialization of Stem Cell Therapies
• The field of stem cell therapy is relatively new and our development efforts may not yield an effective treatment of human diseases.
• Our NurOwn® stem cell therapy, even if approved, may not be accepted in the marketplace; therefore, we may not be able to generate significant revenue, if any.
• Adoption of our NurOwn® stem cell therapy for the treatment of patients with ALS, PMS, AD or other neurodegenerative diseases, even if approved, may be slow or limited. If our NurOwn® stem cell therapy does not achieve broad acceptance as a treatment option for ALS, PMS, AD or other neurodegenerative diseases, our business would be negatively impact our revenue forecast.
• Our success will depend in part on establishing and maintaining effective strategic partnerships and collaborations, which may impose restrictions on our business and subject us to additional regulation.
• We will need to develop or acquire additional capabilities in order to commercialize our NurOwn® stem cell therapy, if approved for sale, and we may encounter unexpected costs or difficulties in doing so.
• We expect to expand our development, regulatory, manufacturing and sales and marketing capabilities, and as a result, we may encounter difficulties in managing our growth, which could disrupt our operations.
• We have never manufactured our NurOwn® stem cell therapy at commercial scale and there can be no assurance that it can be manufactured in compliance with regulations at a cost or in quantities necessary to make it commercially viable.
• Lack of coordination internally among our employees and externally with physicians, hospitals and third-party suppliers and carriers, could cause manufacturing difficulties, disruptions or delays and cause us to not meet our expected clinical trial requirements or potential commercial requirements.
• We face competition in our efforts to develop cell therapies for ALS and other neurodegenerative diseases.
• The trend towards consolidation in the pharmaceutical and biotechnology industries may adversely affect us.
• There is a scarcity of experienced professionals in the field of cell therapy and we may not be able to retain key personnel or hire new key personnel needed to implement our business strategy and develop our products and businesses. If we are unable to retain or hire key personnel, we may be unable to continue to grow our business or to implement our business strategy, and our business may be materially and adversely affected.
• Technological and medical developments or improvements in conventional therapies could render the use of stem cells and our services and planned products obsolete.
• We may expend our limited resources to pursue our NurOwn® stem cell therapy or a specific indication for its use and fail to capitalize on stem cell therapies or indications that may be more profitable or for which there is a greater likelihood of success.
• Our NurOwn® stem cell therapy is based on a novel technology, which may raise development issues that we may not be able to resolve, regulatory issues that could delay or prevent approval or personnel issues that may keep us from being able to develop our treatments.
• We may be subject, directly or indirectly, to federal and state healthcare fraud and abuse laws, false claims laws health information and other health care laws and regulations. If we are unable to comply, or have not fully complied, with such laws, we could face substantial penalties.
• If we are found in violation of privacy and data protection laws, we may be required to pay penalties, be subjected to scrutiny by regulators or governmental entities, or be suspended from participation in government healthcare programs, which may adversely affect our business, financial condition and results of operations.
• Our use of new and evolving technologies, such as artificial intelligence, may present risks and challenges that can impact our business, including by posing cybersecurity and other risks to our confidential and/or proprietary information, including personal information, and as a result we may be exposed to reputational harm and liability.
• It is uncertain to what extent the government, private health insurers and third-party payors will approve coverage or provide reimbursement for the therapies and products to which our services relate. Availability for such reimbursement may be further limited by an increasing uninsured population and reductions in Medicare and Medicaid funding in the United States.
• Unintended consequences of recently adopted health reform legislation in the U.S. may adversely affect our business.
• Ethical and other concerns surrounding the use of stem cell therapy may negatively impact the public perception of our stem cell services, thereby suppressing demand for our services.
• We may be subject to significant product liability claims and litigation which could adversely affect our future earnings and financial condition.
• Political, economic and military instability in Israel may impede our ability to execute our plan of operations.
• If our or our vendors’ security measures are breached or unauthorized access to individually identifiable health information or other personally identifiable information is otherwise obtained, our reputation may be harmed, and we may incur significant liabilities.
• Changes in Tax Law may Adversely Affect our Business and Financial Condition
• Our business may be impacted by macroeconomic conditions, including fears concerning inflation, rising interest rates and volatile market conditions, including as a result of recently announced tariffs or other policy changes by the current U.S. administration, and other uncertainties beyond our control.
• We have identified a material weakness in our system of internal controls pursuant to Section 404 of the Sarbanes-Oxley Act of 2002. If we fail to fully remediate this material weakness, or if we experience additional material weaknesses in the future or otherwise fail to maintain effective internal control over financial reporting in the future, we may not be able to accurately or timely report our financial condition or results of operations.
• Risks Related to Government Regulation
• We are subject to a strict regulatory environment. If we fail to obtain and maintain required regulatory approvals for our potential cell therapy products, our ability to commercialize our potential cell therapy products will be severely limited.
• Additional time may be required to obtain regulatory approval for our product candidates because they are combination products.
• The FDA’s agreement to any Special Protocol Assessment with respect to the study design of our planned Phase 3b clinical trial of NurOwn® for the treatment of ALS does not guarantee any particular outcome from regulatory review, including ultimate approval, and may not lead to a successful review or approval process.
• Even though we have obtained Fast Track designation for NurOwn® for the treatment of ALS in the United States, Fast Track designation by the FDA may not lead to a faster development or regulatory review or approval process and does not increase the likelihood that our product candidates will receive marketing approval.
• Even though we have obtained Orphan Drug Designation for NurOwn® for the treatment of ALS in the United States and EU, and we may apply for Orphan Drug Designation for other product candidates, we may not be able to obtain such designations or maintain the benefits associated with orphan drug status, including orphan drug marketing exclusivity.
• Inadequate funding for the NIH, CMS, FDA, the SEC and other government agencies, including from government shut downs, or other disruptions to these agencies’ operations, including significant leadership, personnel, or policy changes, could prevent new products and services from being developed or commercialized in a timely manner or otherwise prevent those agencies from performing normal business functions on which the operation of our business may rely, which could negatively impact our business.
• Even if regulatory approvals are obtained for our stem cell therapies, we will be subject to ongoing government regulation. If we or one or more of our partners or collaborators fail to comply with applicable current and future laws and government regulations, our business and financial results could be adversely affected.
• We are subject to environmental, health and safety laws.
• We are subject to significant regulation with respect to manufacturing of our NurOwn® stem cell therapy.
• Risks Related to Our Intellectual Property
• If we are unable to obtain and maintain patent protection for any products we develop and for our technology, or if the scope of the patent protection obtained is not sufficiently broad, our competitors could develop and commercialize products and technology similar or identical to ours, and our ability to commercialize any product candidates we may develop, and our technology may be adversely affected.
• Part of our business in the foreseeable future will be based on technology licensed from Ramot and if this license were to be terminated upon failure to make required royalty payments in the future, we would need to change our business strategy and we may be forced to cease our operations.
• If Ramot is unable to obtain patents on the patent applications and technology licensed to our Israeli Subsidiary or if patents are obtained but do not provide meaningful protection, we may not be able to successfully market our proposed products.
• We may be unable to protect our intellectual property from infringement by third parties.
• We may be subject to claims challenging the inventorship or ownership of our patents and other intellectual property.
• Third-party claims of intellectual property infringement may prevent or delay our product discovery and development efforts.
• We may be involved in lawsuits to protect or enforce our patents or the patents of our licensors, which could be expensive, time-consuming and unsuccessful.
• Issued patents covering our products and product candidates could be found invalid or unenforceable if challenged in court or the USPTO.
• Obtaining and maintaining our patent protection depends on compliance with various procedural, document submission, fee payment and other requirements imposed by governmental patent agencies, and our patent protection could be reduced or eliminated for non-compliance with these requirements.
• Changes to patent law in the United States and in foreign jurisdictions could diminish the value of patents in general, thereby impairing our ability to protect our products.
• We have limited foreign intellectual property rights and may not be able to protect our intellectual property rights throughout the world.
• As a result of our reliance on consultants, we may not be able to protect the confidentiality of our technology, which, if disseminated, could negatively impact our plan of operations.
• We received grants from the Israel Innovation Authority, or IIA, we are subject to on-going restrictions.
• We may be subject to damages resulting from claims that we or our employees have wrongfully used or disclosed alleged trade secrets of our competitors or are in breach of non-competition or non-solicitation agreements with our competitors.
• If we do not obtain patent term extension and data exclusivity for any of our current or future product candidates, our business may be materially harmed.
• Risks related to our Common Stock
• We transferred trading of our Common Stock from The Nasdaq Stock Market to the OTCQB Venture Market after our Common Stock was delisted from The Nasdaq. Because our Common Stock is quoted on the OTCQB Venture Market, your ability to sell your shares in the secondary trading market may be limited.
• As a result of the transfer of the our Common Stock from Nasdaq to the OTCQB Venture Market, we anticipate that our stockholders could experience negative consequences related to our securities, including but not limited to: limited availability of market quotations for our securities; a reduced level of trading activity in the secondary trading market for shares of our Common Stock; a limited amount of analyst coverage; and decreased ability to issue additional securities or obtain additional financing in the future.
• The National Securities Markets Improvement Act of 1996, which is a federal statute, prevents or preempts the states from regulating the sale of certain securities, which are referred to as “covered securities.” Shares of our Common Stock were considered to be covered securities because they were listed on Nasdaq. Because our Common Stock is no longer listed on Nasdaq, our Common Stock is not deemed covered securities, and we are subject to regulation in each state in which we offer our securities.
• The price and trading volume of our stock is expected to be volatile.
• Your percentage ownership will be diluted by future issuances of our securities.
• ACCBT holds equity participation rights and other rights that could affect our ability to raise funds.
• You may experience difficulties in attempting to enforce liabilities based upon U.S. federal securities laws against us and our non-U.S. resident directors and officers.
• If we fail to implement and maintain an effective system of internal controls, we may be unable to accurately report our results of operations or prevent fraud, and investor confidence and the market price of our Common Stock may be materially and adversely affected.
• Delaware law could discourage a change in control, or an acquisition of us by a third party, even if the acquisition would be favorable to you, and thereby adversely affect existing stockholders.
• We do not expect to pay dividends in the foreseeable future, and accordingly you must rely on stock appreciation for any return on your investment.