BCLI

These risks include, among others: ● We are and could be further subject to securities class action litigation and other types of stockholder litigation. ● We will need substantial additional funding to pursue our business objectives and continue our operations.
For example, the Israel-Hamas war and/or other military conflicts with Lebanon, Syria, Iran or other hostile countries may lead to difficulties in bringing operational personnel and equipment into Israel. ● There is substantial doubt about our ability to continue as a going concern.
If we are unable to raise additional capital, we may be required to cease operations. ● Our common stock has been delisted from The Nasdaq Stock Market and now trades on the OTCQB Venture Market, which may result in reduced liquidity and could negatively impact the trading price of our common stock. ● 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. ● We may be unable to protect our intellectual property from infringement by third parties, which could harm our competitive position.
Our ability to access the capital markets or to enlist partners is mainly dependent on the progress of our research and development and regulatory approval of our products. To date, the Company has not generated revenues from its activities and has incurred substantial operating losses.
Management’s plan includes raising funds from outside potential investors.
Should we raise additional funds through the issuance of equity, equity-related or debt securities, these securities may have rights, preferences or privileges (including registrations rights) senior to those of the rights of our Common Stock and our stockholders will experience additional dilution.
We have a history of losses and we expect to incur losses for the foreseeable future.
We had no operational revenues for the fiscal years ended December 31, 2022, December 31, 2023, December 31, 2024, or December 31, 2025.
In 2026 and the upcoming years, the Company will focus on initiating and completing a Phase 3b trial and commercialization of NurOwn® for ALS, if approved.
We may not be able to continue as a going concern if we do not execute our business plan or obtain additional financing in the future if necessary.
Our independent accountant’s audit report included on this Annual Report on Form 10-K states that there is substantial doubt about our ability to continue as a going concern.
We have incurred only losses since our inception, raising substantial doubt about our ability to continue as a going concern.
Therefore, our ability to continue as a going concern is highly dependent upon us executing our business plan in the planned amount of time allotted and obtaining additional financing for our planned operations, if necessary.
There can be no assurance that we will be able to raise any additional funds, or if we are able to raise additional funds, that such funds will be in the amounts required or on terms favorable to us.
The stock market in general has experienced extreme price and volume fluctuations that have often been unrelated or disproportionate to the operating performance of these companies.
On November 10, 2022, we announced that we had received a RTF letter from the FDA regarding our BLA.
If we fail to obtain regulatory approval for our NurOwn® stem cell therapy, we will be unable to market and sell it and we may never be profitable.
Comparisons of outcomes of other reported clinical trials may provide some insight into the efficacy of NurOwn® stem cell therapy, however, these studies may be of limited comparative value due to the many factors that affect the outcome of clinical trials, some of which are not apparent in published reports. Additionally, several of our past, planned and ongoing clinical trials utilize an “open-label” trial design.
None have been approved by the FDA for commercial sale in the US, and the pathway to regulatory approval for our stem cell therapies may accordingly be more complex and lengthy.
If our clinical trials are unsuccessful, or if we do not complete our clinical trials, we may not receive regulatory approval for or be able to commercialize our stem cell therapies.
If we do not succeed in conducting and managing our preclinical development activities or clinical trials, or in obtaining regulatory approvals, we might not be able to commercialize our stem cell therapies, or might be significantly delayed in doing so, which will materially harm our business.
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.
In addition, the manufacturing and delivery processes associated with our treatment will require physicians to adjust their current treatment of patients, which may delay or prevent market adoption of our NurOwn® stem cell therapy as a preferred therapy, even if approved.
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.
These activities would require substantial additional funds and we would need to hire and train significant numbers of qualified employees to staff these facilities.
If any contract manufacturing organization (“CMO”) with whom we contract fails to perform its obligations, we may be forced to manufacture the materials ourselves, for which we may not have the capabilities or resources, or enter into an agreement with a different CMO, which we may not be able to do on reasonable terms, if at all.
We may be unsuccessful in demonstrating the comparability of clinical supplies which could require the conduct of additional clinical trials. Furthermore, we must supply all necessary documentation, including product characterization and process validation, to regulatory authorities in support of our BLA on a timely basis and must adhere to cGMP and cGTP regulations enforced by the regulatory authority through its facilities inspection program.
To date, approved conventional therapies have not shown significant clinical benefit as disease modifying therapies in the indications that we are currently working on.
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.
As a result of pursuing the development of our NurOwn® stem cell therapy, we may fail to develop stem cell therapies or address indications based on other scientific approaches that may offer greater commercial potential 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.
For more information, see “Business – Other Healthcare Laws and Compliance Requirements.
Additionally, we are subject to state and foreign equivalents of each of the healthcare laws and regulations described above, among others, some of which may be broader in scope and may apply regardless of the payor.
If our operations, including our arrangements with physicians and other healthcare providers, some of whom receive share options as compensation for services provided, are found to be in violation of any of such laws or any other governmental regulations that apply to us, we may be subject to penalties, including, without limitation, administrative, civil and criminal penalties, damages, fines, disgorgement, contractual damages, reputational harm, diminished profits and future earnings, the curtailment or restructuring of our operations, exclusion from participation in federal and state healthcare programs (such as Medicare and Medicaid), and imprisonment, as well as additional reporting obligations and oversight if we become subject to a corporate integrity agreement or other agreement to resolve allegations of non-compliance with these laws, any of which could adversely affect our ability to operate our business and our financial results. 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.
Although clinical trial data and protected health information subject to HIPAA are currently exempt from CCPA, we may be subject to the CCPA with respect to other personal information regarding California residents.
The CCPA marks the beginning of a trend toward more stringent privacy legislation in the U.S., which could increase our potential liability and adversely affect our business.
If we develop or use AI systems governed by these laws or regulations, we will need to meet higher standards of data quality, transparency, monitoring and human oversight, and we would need to adhere to specific and potentially burdensome and costly ethical, accountability, and administrative requirements, with the potential for significant enforcement or litigation in the event of any perceived non-compliance.
The rapid evolution of artificial intelligence will require the application of significant resources to design, develop, test and maintain such systems to help ensure that artificial intelligence is implemented in accordance with applicable law and regulation and in a socially responsible manner and to minimize any real or perceived unintended harmful impacts.
Congressional inquiries and proposed and enacted federal and state legislation designed to, among other things, bring more transparency to drug pricing, reduce the cost of prescription drugs under Medicare, review the relationship between pricing and manufacturer patient programs, and reform government program reimbursement methodologies for drugs.
Individual states in the United States have also become increasingly active in passing legislation and implementing regulations designed to control pharmaceutical and biological product pricing, including price or patient reimbursement constraints, discounts, restrictions on certain drug access and marketing cost disclosure and transparency measures, and designed to encourage importation from other countries and bulk purchasing.
Although we currently do not expect the ongoing conflict to affect our customers, manufacturing, research and development, supply chain, commercialization activities and current clinical studies, there can be no assurances that further unforeseen events will not have a material adverse effect on us or our operations in the future.

and 69 more.

Gone since FY2024

These risks include, among others: ● If we fail to regain compliance with the continued listing requirements of Nasdaq, our Common Stock may be delisted and the price and liquidity of our common stock may be negatively impacted. ● We are and could be further subject to securities class action litigation and other types of stockholder litigation. ● We will need substantial additional funding to pursue our business objectives and continue our operations.
For example, the Israel-Hamas war and/or other military conflicts with Lebanon, Syria, Iran or other hostile countries may lead to difficulties in bringing operational personnel and equipment into Israel.
Our ability to access the capital markets or to enlist partners is mainly dependent on the progress of our research and development and regulatory approval of our products.
To date, the Company has not generated revenues from its activities and has incurred substantial operating losses.
Management’s plan includes raising funds from outside potential investors, including under the ATM Program.
Should we raise additional funds through the issuance of equity, equity-related or debt securities, these securities may have rights, preferences or privileges (including registrations rights) senior to those of the rights of our Common Stock and our stockholders will experience additional dilution. We have a history of losses and we expect to incur losses for the foreseeable future.
We had no operational revenues for the fiscal years ended December 31, 2021, December 31, 2022 December 31, 2023, or December 31, 2024.
In 2024 and the upcoming years, the Company will focus on initiating and completing a Phase 3b trial and commercialization of NurOwn® for ALS, if approved.
If we fail to regain compliance with the continued listing requirements of Nasdaq or other conditions set forth in the Determination Letter, our Common Stock may be delisted, and the price and liquidity of our Common Stock may be negatively impacted.
On July 18, 2024, we received a letter from the Nasdaq Listing Qualifications Staff (the “Staff”) indicating that we had not maintained Nasdaq’s required market value of listed securities (“MVLS”) of $35 million from June 2, 2024 to July 17, 2024.
Under Nasdaq’s listing rules, we had 180 calendar days from this notice, until January 14, 2025 (the “Compliance Date”), to regain compliance with Nasdaq’s MVLS.
On January 15, 2025, the Staff notified us in writing that we failed to regain compliance with the MVLS requirement by the Compliance Date.
As such, we had until January 22, 2025 to request an appeal of Nasdaq’s determination to delist, or our common stock would be delisted from The Nasdaq Capital Market at the opening of business on January 24, 2025.
We promptly submitted our request to appeal Nasdaq’s determination on January 21, 2025, and on that same day, we received formal written notice from the Staff that the Panel would consider our appeal at an oral hearing on February 25, 2025, and that to the extent permitted by Nasdaq Listing Rules, the delisting action referenced in the Staff’s determination letter was stayed, pending a final written decision by the Panel.
Subsequently, we presented our compliance plan to the Panel at the oral hearing on February 25, 2025.
On March 25, 2025, we received the Panel’s Determination Letter, granting the Company’s request for an extension (the “Extension”) to regain compliance with certain continued Nasdaq listing requirements through the Company’s requested extension date of June 30, 2025 (the “Extension Date”).
Our Plan includes, among other items, satisfying a $2.5 million minimum stockholders’ equity requirement under Nasdaq Listing Rule 5550 in lieu of the MVLS requirement and conducting certain capital raising activities to attain such $2.5 million of stockholders’ equity. The Extension is subject to certain conditions, including, among others, that we demonstrate compliance with Nasdaq Listing Rule 5550 and makes progress in completing the Plan to raise capital, as well as the provision and public disclosure of certain information prior to the Extension Date.
We intend to provide or publicly disclose, as the case may be, the information required by the Panel’s decision within the timeframe required thereby.
While we are actively pursuing a range of initiatives aimed at completing our Plan, the Company cannot assure its stockholders that it will be successful in raising capital or in satisfying the minimum stockholders’ equity requirement by the Extension Date.
On November 10, 2022, we announced that we had received an RTF letter from the FDA regarding our BLA.
On June 26, 2024, the Company announced that it has reached alignment with FDA on the Chemistry, Manufacturing, and Controls (CMC) aspects of Brainstorm’s Phase 3b clinical trial for NurOwn (R), its investigational therapy for ALS. If we fail to obtain regulatory approval for our NurOwn® stem cell therapy, we will be unable to market and sell it and we may never be profitable.
Comparisons of outcomes of other reported clinical trials may provide some insight into the efficacy of NurOwn® stem cell therapy, however, these studies may be of limited comparative value due to the many factors that affect the outcome of clinical trials, some of which are not apparent in published reports.
Additionally, several of our past, planned and ongoing clinical trials utilize an “open-label” trial design.
None have been approved by the FDA for commercial sale in the US, and the pathway to regulatory approval for our stem cell therapies may accordingly be more complex and lengthier.
If our clinical trials are unsuccessful, or if we do not complete our clinical trials, we may not receive regulatory approval for or be able to commercialize our stem cell therapies. If we do not succeed in conducting and managing our preclinical development activities or clinical trials, or in obtaining regulatory approvals, we might not be able to commercialize our stem cell therapies, or might be significantly delayed in doing so, which will materially harm our business.
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 impacting our revenue forecast.
In addition, the manufacturing and delivery processes associated with our treatment will require physicians to adjust their current treatment of patients, which may delay or prevent market adoption of our NurOwn® stem cell therapy as a preferred therapy, even if approved. 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.
These activities would require substantial additional funds and we would need to hire and train significant numbers of qualified employees to staff these facilities. If any contract manufacturing organization (“CMO”) with whom we contract fails to perform its obligations, we may be forced to manufacture the materials ourselves, for which we may not have the capabilities or resources, or enter into an agreement with a different CMO, which we may not be able to do on reasonable terms, if at all.
We may be unsuccessful in demonstrating the comparability of clinical supplies which could require the conduct of additional clinical trials.
Furthermore, we must supply all necessary documentation, including product characterization and process validation, to regulatory authorities in support of our BLA on a timely basis and must adhere to cGMP and cGTP regulations enforced by the regulatory authority through its facilities inspection program.
To date, approved conventional therapies have not shown significant clinical benefit as disease modifying therapies in the indications that we are currently working on. 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.
As a result of pursuing the development of our NurOwn® stem cell therapy, we may fail to develop stem cell therapies or address indications based on other scientific approaches that may offer greater commercial potential 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.
For more information, see “Business – Other Healthcare Laws and Compliance Requirements. Additionally, we are subject to state and foreign equivalents of each of the healthcare laws and regulations described above, among others, some of which may be broader in scope and may apply regardless of the payor.
If our operations, including our arrangements with physicians and other healthcare providers, some of whom receive share options as compensation for services provided, are found to be in violation of any of such laws or any other governmental regulations that apply to us, we may be subject to penalties, including, without limitation, administrative, civil and criminal penalties, damages, fines, disgorgement, contractual damages, reputational harm, diminished profits and future earnings, the curtailment or restructuring of our operations, exclusion from participation in federal and state healthcare programs (such as Medicare and Medicaid), and imprisonment, as well as additional reporting obligations and oversight if we become subject to a corporate integrity agreement or other agreement to resolve allegations of non-compliance with these laws, any of which could adversely affect our ability to operate our business and our financial results.
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.
Although clinical trial data and protected health information subject to HIPAA are currently exempt from CCPA, we may be subject to the CCPA with respect to other personal information regarding California residents. The CCPA marks the beginning of a trend toward more stringent privacy legislation in the U.S., which could increase our potential liability and adversely affect our business.
If we develop or use AI systems governed by these laws or regulations, we will need to meet higher standards of data quality, transparency, monitoring and human oversight, and we would need to adhere to specific and potentially burdensome and costly ethical, accountability, and administrative requirements, with the potential for significant enforcement or litigation in the event of any perceived non-compliance. The rapid evolution of artificial intelligence will require the application of significant resources to design, develop, test and maintain such systems to help ensure that artificial intelligence is implemented in accordance with applicable law and regulation and in a socially responsible manner and to minimize any real or perceived unintended harmful impacts.
Congressional inquiries and proposed and enacted federal and state legislation designed to, among other things, bring more transparency to drug pricing, reduce the cost of prescription drugs under Medicare, review the relationship between pricing and manufacturer patient programs, and reform government program reimbursement methodologies for drugs. Individual states in the United States have also become increasingly active in passing legislation and implementing regulations designed to control pharmaceutical and biological product pricing, including price or patient reimbursement constraints, discounts, restrictions on certain drug access and marketing cost disclosure and transparency measures, and designed to encourage importation from other countries and bulk purchasing.
Although we currently do not expect the ongoing conflict to affect our customers, manufacturing, research and development, supply chain, commercialization activities and current clinical studies, there can be no assurances that further unforeseen events will not have a material adverse effect on us or our operations in the future. The Israel Defense Force (the “IDF”), the national military of Israel, is a conscripted military service, subject to certain exceptions.

and 35 more.

Sentence-level comparison of Item 1A in the two most recent 10-Ks (FY2024 ↗, FY2025 ↗). A reworded sentence counts as one dropped and one added, so heavy edits read as low “kept”. Headings and page furniture are stripped; nothing is summarised by a model.

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