Year-over-year tone shift - average net-tone change across Risk Factors and MD&A vs the prior 10-K. This filing is -0.54pp more bearish than last year's.
Why YoY instead of absolute: the LM lexicon has ~6.6× more negative words than positive (legal/risk-disclosure language is heavy on hedging), so every 10-K reads bearish on raw tone. Year-over-year change strips that bias and surfaces the actual shift in management's framing.
Tone shift by section
The two components the gauge averages: how Risk Factors and MD&A each shifted in net tone versus last year's 10-K. The headline above is their average, so a green needle over a soft section just means the other section carried it.
Risk Factors
-0.54pp
Lean -
Net-tone change vs last year's 10-K.
MD&A
-0.54pp
Lean -
Net-tone change vs last year's 10-K.
Per-snippet highlights
Sentence-level sentiment highlighting with category and subcategory filters is coming once the snippet-scoring pipeline lands. For now, dig into the actual section text on the Sections tab.
Language change vs prior 10-K
Risk Factors (Item 1A) - words with the biggest YoY frequency increase
Negative rising
losses+3
terminate+3
harmed+2
delay+2
conflict+2
Positive rising
successfully+3
progress+3
profitability+2
favorable+2
good+2
Risk Factors (Item 1A)
12,277 words
item 1a. risk factors
Summary Risk Factors
Our business is subject to numerous risks and uncertainties, any one of which could have a materially adverse effect on our results of operations, financial condition or business. These risks include, but are not limited to, those listed below.
We have a history of operating losses and expect to incur additional losses in the future.
We may need to raise significant additional capital, which we may be unable to obtain.
We may not be successful in our efforts to complete and integrate current and/or future acquisitions, which could disrupt our current business activities and adversely affect our results of operations or future growth.
We may not be successful in our efforts to complete and integrate current and/or future joint ventures, which could disrupt our current business activities and adversely affect our results of operations or future growth.
Language change vs prior 10-K
MD&A (Item 7) - words with the biggest YoY frequency increase
Negative rising
loss+12
discontinued+12
losses+2
disclosed+1
undisclosed+1
Positive rising
gain+4
benefit+3
exclusive+1
collaboration+1
MD&A (Item 7)
4,180 words
item 7. management’s discussion and analysis of financial condition and results of operations
The following discussion and analysis of our financial condition and results of operations should be read in conjunction with our financial statements and the related notes appearing elsewhere in this Annual Report. In addition to historical information, the following discussion contains forward-looking statements that involve risks, uncertainties and assumptions. See “Forward-looking Statements” for a discussion of the uncertainties and assumptions associated with these statements. Our actual results may differ materially from those discussed below.
Overview
MitoCareX is a drug discovery company dedicated to the development of cancer therapeutics by targeting the mitochondrial carrier family (SLC25A protein family) with a specific focus on one undisclosed SLC25A protein of interest. The company’s core technology and know-how relate to structural biology combined with computational chemistry – a knowledge that can be utilized for potentially each of the 53 protein members belonging to the SLC25A family (i.e., a platform-based drug discovery company). MitoCareX’s current focus is on Non-Small Cell Lung Cancer (NSCLC) therapeutics however it may consider other oncology and non-oncology indications in the future. MitoCareX’s mission is to be the foremost biopharma company that develops and delivers transformative metabolic-based therapies that improve and extend the lives of patients.
Solterra engages in the development of renewable energy projects through its subsidiaries. Currently, operations are conducted in Italy, Poland, and Germany, with potential expansion to additional countries in the future. Solterra’s business strategy primarily involves selling renewable energy projects to third parties at various stages of development, from the initial land identification and project through construction, operation, or sale to a third party. Currently, most projects are expected to be sold at various development stages, with the possibility of a larger portion of projects being held long-term for operation by Solterra in the future.
Because of our limited operating history, we may not be able to successfully operate our business or execute our business plan.
Our business and operations may be affected by unexpected events, including climate change conditions, which could materially harm our financial results.
Conditions in the global economy, including inflation and recessionary pressures, may adversely affect our business, financial condition and results of operations.
Increased attention to environmental, social, and governance matters and conservation measures may adversely impact our business or that of our manufacturers.
Our relationship with our employees could deteriorate, and certain key employees could leave, which could adversely affect our business and results of operations.
Our business and financial results may be adversely affected due to MitoCareX’s limited operating history, lack of revenue and history of operating losses.
If MitoCareX is unable to successfully develop and commercialize its anti-cancer small molecule therapeutics (ACSMT) or obtain required regulatory approvals, our business could be materially harmed.
We may be unable to raise the additional capital required to fund MitoCareX’s development programs on acceptable terms, or at all, which could force us to delay, limit, reduce or terminate those programs.
Delays or failures in MitoCareX’s early-stage pipeline, including its chemical scaffold and MITOLINE™ algorithm, could materially harm our business and our ability to achieve our strategic objectives.
We rely on third parties for key aspects of MitoCareX’s development, manufacturing and clinical activities, which could increase costs and delay or prevent commercialization.
We are subject to risks relating to portfolio concentration.
Our operating results may fluctuate, which makes our results difficult to predict and could cause our results to fall short of expectations.
International expansion of our business exposes us to business, regulatory, political, operational, financial and economic risks associated with doing business outside of the United States or Israel.
Our business depends to some extent on international transactions.
If we are unable to secure and maintain patent or other intellectual property protection for the intellectual property used in our products, our ability to compete will be harmed.
If we are unable to prevent unauthorized use or disclosure of our proprietary trade secrets and unprotected know-how, our ability to compete will be harmed.
We could become subject to patent and other intellectual property litigation that could be costly, result in the diversion of management’s attention, require us to pay damages and force us to discontinue selling our products.
We may be subject to claimschallenging the inventorship or ownership of our patents and other intellectual property.
We may experience claims that our products infringe the intellectual property rights of others, which may cause us to incur unexpected costs or prevent us from selling our products or services.
If we or our contractors or service providers fail to comply with laws and regulations, we or they could be subject to regulatory actions, which could affect our ability to develop, market and sell our products or future products that we may develop and may harm our reputation in our industry.
Regulatory reforms may adversely affect our ability to sell our products profitably.
Our investment in the solar energy sector is both for strategic and financial reasons but we may not realize a return on our investments.
Climate-related risks may adversely affect Solterra’s business and our joint venture value.
Regulatory and Compliance Changes may Adversely Impact Solterra’s Operations and Our Joint Venture Value.
Permitting and Licensing Delays may Impact Solterra’s Project Timelines and Our Joint Venture Value.
Fluctuations in Electricity Tariffs may Impact Solterra’s Revenue and Our Joint Venture Value.
Supply Chain and Contractor Disruptions may Delay Solterra’s Projects and Affect Our Joint Venture Value.
Equipment Malfunctions and Downtime may Impact Solterra’s Operations and Our Joint Venture Value.
Intense Competition in the Renewable Energy Sector may affect Solterra’s Market Share and Our Joint Venture Value.
Joint Venture and Partnership Risks may Affect Solterra’s Projects and Our Joint Venture Value.
Safety and Operational Risks may Impact Solterra’s Business and Our Joint Venture Value.
The evolution of our business strategy may not be successful, and we may require additional financing, have increased operational costs or other financial harm to our business and financial condition
Conditions in Israel, including Israel’s conflicts with Hamas and other parties in the region, as well as political and economic instability, may adversely affect our operations and limit our ability to market our products, which would lead to a decrease in revenues.
We may not be able to enforce covenants not-to-compete under current Israeli law that might result in added competition for our products.
It may be difficult to acquire jurisdiction and enforce liabilities against our officers and directors who are based in Israel.
If we fail to comply with the Nasdaq Capital Market listing requirements, we will be subject to potential delisting from the Nasdaq Capital Market.
The market price of our common stock may be highly volatile.
Sales of a substantial number of shares of our common stock in the public market by our existing stockholders could cause our share price to fall.
We may need additional capital, and the sale of additional shares or equity or debt securities could result in additional dilution to our stockholders.
Nevada law and provisions in our articles of incorporation and bylaws could make a merger, tender offer or proxy contest difficult, thereby depressing the market price of our common stock.
If we fail to comply with the continued listing requirements of the Nasdaq Capital Market, our common stock may be delisted.
We may be subject to securities litigation, which is expensive and could divert management attention.
If securities or industry analysts do not publish or cease publishing research or reports about us, our business or our market, or if they adversely change their recommendations or publish negative reports regarding our business or our common stock, our stock price and trading volume could decline.
We do not anticipate paying any cash dividends in the foreseeable future.
Disruptions to our information technology systems due to cyber-attacks or our failure to upgrade and adjust our information technology systems, may materially impair our operations, hinder our growth and materially and adversely affect our business and results of operations.
Failure to comply with anti-bribery, anti-corruption and anti-money laundering laws could subject us to penalties and other adverse consequences.
We incur additional increased costs as a result of the listing of our common stock for trading on Nasdaq, and our management is required to devote substantial time to new compliance initiatives and reporting requirements.
We face risks related to compliance with corporate governance laws and financial reporting standards.
The ongoing conflict in Ukraine may result in market volatility that could adversely affect our business.
If we fail to implement and maintain effective internal control over financial reporting, we may be unable to report our financial results accurately or meet our reporting obligations.
Risks Related to Our Financial Condition and Capital Requirements
We have a history of operating losses and expect to incur additional losses in the future.
We have sustained losses in recent years, which as of December 31, 2025, accumulated to $38,528,000. We are likely to continue to incur significant net losses for at least the next several years as we continue to pursue our strategy, which is currently focused on converting pilots into paying customers, following lengthy sale cycles of at least two seasons. Our losses have had, and will continue to have, an adverse effect on our stockholders’ equity and working capital. Any failure to achieve and maintain profitability would continue to have an adverse effect on our stockholders’ equity and working capital and could result in a decline in our share price or cause us to cease operations. As discussed in Note 1 to the financial statements, as a result of these factors, there is substantial doubt about our ability to continue as a going concern.
We may need to raise significant additional capital, which we may be unable to obtain.
Our capital requirements in connection with our research and development activities and transition to commercial operations have been significant. We will require additional funds to continue running pilots and testing our technologies and products, to obtain intellectual property protection relating to our technologies, and to market our products. There can be no assurance that financing will be available in amounts or on terms acceptable to us, if at all. If we are not able to procure adequate additional financing, we may not be able to fully implement our growth plans and we will be required to cease operations until such additional capital is raised. Any additional financings that we may require in the future will dilute the percentage ownership interests of our stockholders and may adversely affect our earnings and net book value per share.
Risks Related to Our Business, Industry and Business Operations
We may not be successful in our efforts to complete and integrate current and/or future acquisitions, which could disrupt our current business activities and adversely affect our results of operations or future growth.
Any acquisition may involve many risks, including the risks of:
diverting management’s attention and other resources from our ongoing business concerns;
entering markets in which we have no prior experience;
improperly evaluating new services, products and markets;
being unable to maintain uniform standards, controls, procedures and policies;
failing to comply with governmental requirements pertaining to acquisitions of local companies or assets by foreign entities;
being unable to integrate new technologies or personnel;
incurring the expenses of any undisclosed or potential liabilities; and
the departure of key management and employees.
If we are unable to successfully complete future acquisitions, our ability to grow our business or to operate our business effectively could be reduced, and our business, financial condition and operating results could suffer. Even if we are successful in completing acquisitions, we cannot assure that we will be able to integrate the operations of the acquired business without encountering difficulty regarding different business strategies with respect to marketing and integration of personnel with disparate business backgrounds and corporate cultures. The integration of MitoCareX, which was incorporated in February 2022, is still in progress and, we cannot assure that such process will be completed without encountering difficulties. Further, in certain cases, mergers and acquisitions require special approvals, or are subject to scrutiny by the local authorities, and failing to comply with such requirements or to receive such approvals, may prevent or limit our ability to complete the acquisitions as well as expose us to legal proceedings prior or following the consummation of such acquisitions. In some cases, such proceedings, if initiated, may conclude in a requirement to divest portions of the acquired business.
We may not be successful in our efforts to complete and integrate current and/or future joint ventures, which could disrupt our current business activities and adversely affect our results of operations or future growth.
We may face challenges in managing and integrating our PV joint venture with Solterra, as well as any future joint ventures, which could disrupt our current business activities and adversely affect our results of operations or future growth. Engaging in joint ventures involves several risks, including:
Diverting management’s attention and resources from our ongoing business concerns;
Entering markets in which we have limited or no prior experience;
Improperly evaluating new services, products, and markets;
Being unable to maintain uniform standards, controls, procedures, and policies;
Failing to comply with governmental requirements related to joint ventures;
Being unable to integrate new technologies or personnel effectively;
Incurring expenses from undisclosed or potential liabilities; and
The departure of key management and employees.
If we are unable to successfully manage and integrate our joint ventures, our ability to grow our business or operate effectively could be compromised, potentially impacting our business, financial condition, and operating results. Even if we succeed in forming joint ventures, we cannot guarantee seamless integration of operations without encountering difficulties related to differing business strategies, marketing approaches, and integration of personnel with diverse backgrounds and corporate cultures. Additionally, joint ventures may require special approvals or be subject to scrutiny by local authorities, and failing to comply with such requirements or obtain necessary approvals could limit our ability to complete joint ventures and expose us to legal proceedings. In some cases, such proceedings may result in a requirement to divest portions of the joint venture.
Conditions in the global economy, including inflation and recessionary pressures, may adversely affect our business, financial condition and results of operation.
The recent historically high inflation in the U.S., geopolitical issues, continuous increases in interest rates, unstable global conditions and changes in exchange rates have led to global economic instability. Macroeconomic conditions may adversely affect the industries in which we operate, including the biotechnology and renewable energy sectors. Inflation, rising interest rates and volatility in global financial markets may increase our research and development expenses, raise the cost of materials and services, disrupt supply chains or limit our access to capital. In addition, higher interest rates and economic uncertainty may reduce investments in renewable energy projects and slow the pace of development and commercialization of new technologies. and could, consequently, have a material adverse effect on our business, financial condition and results of operations. Moreover, the new Trump administration has recently imposed tariffs on certain U.S. imports, and indicated that he would impose a 25% tariff against all goods imported from Canada and Mexico, and a 10% tariff on certain imports from China; China and other countries have responded with retaliatory tariffs on certain U.S. exports. We cannot predict what effects these tariffs and potential additional tariffs will have on our business. However, these tariffs and other trade restrictions could increase our operating costs, reduce our gross margins or otherwise negatively impact our financial results. Changes in international trade policies, tariffs or other restrictions on imports of equipment or materials used in our technologies could also increase our operating costs or otherwise negatively affect our financial results. Any of the foregoing factors could have a material adverse effect on our business, financial condition and results of operations.
Increased attention to environmental, social, and governance (“ESG”) matters and conservation measures may adversely impact our business or that of our manufacturers.
Public companies are still facing scrutiny related to ESG practices and disclosures from certain investors, capital providers, shareholder advocacy groups, other market participants, and other stakeholder groups. For example, certain institutional and individual investors have requested various ESG-related information and disclosures as they increasingly incorporate ESG criteria in making investment and voting decisions. With this focus, public reporting regarding ESG practices is still broadly expected. The existing scrutiny may result in increased costs, enhanced compliance or disclosure obligations, or other adverse impacts on our business, financial condition or results of operations. If our ESG practices and reporting do not meet investor or other stakeholder expectations, we may be subject to investor or regulator engagement regarding such matters.
In addition, new sustainability rules and regulations may continue to be introduced in various states and other jurisdictions. Such climate change-related regulations or interpretations of existing laws may result in enhanced disclosure obligations that could negatively affect us and materially increase our regulatory burden. Increased regulations generally increase the costs to us, and those higher costs may continue to increase if new laws require additional resources, including spending more time, hiring additional personnel or investing in new technologies.
Moreover, this could result in increased management time and attention to ensure we are compliant with the regulations and expectations. Our failure to comply with any applicable rules or regulations could lead to penalties and adversely impact our reputation, access to capital and employee retention. Such ESG matters may also impact third parties on which we rely, which may augment or cause additional impacts on our business, financial condition, or results of operations.
Our relationship with our employees could deteriorate, and certain key employees could leave, which could adversely affect our business and results of operations.
Our business involves complex operations and demands a management team to determine and implement our strategy and workforce that is knowledgeable and has expertise in many areas necessary for our operations. As a company focused on commercializing our completed pilots into paying customers in the highly-specialized horticultural post-harvest field, we rely on our ability to attract and retain skilled employees, consultants and contractors. The departure of highly skilled employees, consultants or contractors or one or more employees who hold key regional management positions could have an adverse impact on our operations.
In addition, to execute our growth plan we must attract and retain highly qualified personnel. Competition for these employees exists; new members of management must have significant industry expertise when they join us or engage in significant training which, in many cases, requires significant time before they achieve full productivity. If we fail to attract, train, retain, and motivate our key personnel, our business and growth prospects could be severelyharmed.
Furthermore, we are dependent upon managers to oversee our operations. Thus, there can be no assurance that a manager’s experience will be sufficient to successfullyachieve our business objectives. All decisions regarding the management of our affairs will be made exclusively by our officers and directors. In the event these people are ineffective, our business and results of operation would likely be adversely affected.
Risks Related to Business Operations of MitoCareX
MitoCareX has no operating history.
MitoCareX is a drug discovery and development company with a current focus on oncology with a limited operating history upon which you can evaluate its business and prospects. MitoCareX commenced operations in 2022, has no products approved for commercial sale, and has not generated any revenue from the sale of its products. To date, MitoCareX has focused primarily on organizing and staffing its company, business planning, raising capital, building its proprietary computational platform, discovering potential Anti-Cancer Small Molecule Therapeutics (ACSMT), establishing its intellectual property portfolio, conducting research, establishing arrangements with third parties for the manufacture of ACSMT and supply of related raw materials, and providing general and administrative support for these operations. Its scientific approach to the discovery and development of ACSMT is unproven and MitoCareX does not know whether MitoCareX will be able to develop or obtain regulatory approval for any products of commercial value. MitoCareX has only one type of chemical scaffold of ACSMT in early development. MitoCareX has not yet completed any preclinical and clinical trials, successfully developed and validated a diagnostic test, obtained regulatory approvals, manufactured products on a commercial scale, or arranged for a third party to do so on its behalf, or conducted sales or marketing activities necessary for successful product commercialization. Consequently, any predictions made about its future success or viability may not be as accurate as they could be if MitoCareX had a history of successfully developing and commercializing biopharmaceutical products.
MitoCareX has incurred significant operating losses since its inception and expects to incur significant losses for the foreseeable future. MitoCareX does not have any products approved for sale and has not generated any revenue since its inception. If MitoCareX is unable to successfully develop and obtain the requisite approval for and commercialize ACSMT, MitoCareX may never generate revenue. MitoCareX incurred net losses of $1,394,000 and $886,000 for the year ended December 31, 2025 and for the year ended December 31, 2024, respectively. As of December 31, 2025, MitoCareX had an accumulated deficit of $3,154,000. Substantially all of its losses have resulted from expenses incurred in connection with its research and development programs and from general and administrative costs associated with its operations. ACSMT will require substantial additional development time and resources before MitoCareX would be able to apply for or receive regulatory approvals and begin generating revenue from product sales. MitoCareX expects to continue to incur losses for the foreseeable future, and MitoCareX anticipates these losses will increase substantially as MitoCareX continues its development of, seeks regulatory approval for, and potentially commercializes ACSMT and seeks to discover and develop additional solutions as well as operate as a public company.
To become and remain profitable, MitoCareX must succeed in discovering, developing, obtaining regulatory approvals for, and eventually commercializing products that generate significant revenue. This will require MitoCareX to be successful in a range of challenging activities, including preclinical studies and completing clinical trials of ACSMT, discovering additional ACSMTs, obtaining regulatory approval for these and manufacturing, marketing, and selling any products for which MitoCareX may need to obtain regulatory approval. MitoCareX is in the preliminary stages of these activities. MitoCareX may never succeed in these activities and, even if MitoCareX does, it may never generate revenue that is significant enough to achieveprofitability. In addition, MitoCareX has not yet demonstrated an ability to successfullyovercome many of the risks and uncertainties frequently encountered by companies in new and rapidly evolving fields, particularly in the biopharmaceutical industry. Because of the numerous risks and uncertainties associated with biopharmaceutical product development, MitoCareX is unable to accurately predict the timing or amount of increased expenses or when, or if, MitoCareX will be able to achieveprofitability. Even if MitoCareX does achieveprofitability, MitoCareX may not be able to sustain or increase profitability on a quarterly or annual basis. Its failure to become and remain profitable may have an adverse effect on its value and could impair its ability to raise capital, expand its business, maintain its research and development efforts, diversify its ACSMT pipeline, achieve its strategic objectives, or even continue its operations. A decline in the value of MitoCareX could also cause you to lose all or part of your investment.
MitoCareX will require substantial additional capital to finance its operations, and a failure to obtain this necessary capital when needed on acceptable terms, or at all, could force it to delay, limit, reduce, or terminate ACSMT development programs, MITOLINE™ related validations and optimizations, commercialization efforts or other operations.
The development of ACSMT, including conducting preclinical studies and clinical trials, is a very time-consuming, capital-intensive, and uncertain process. Since its acquisition in October 2025, MitoCareX’s operations have continued to consume substantial amounts of cash. The Company expects that MitoCareX’s expenses to substantially increase in connection with MitoCareX ongoing activities, particularly when MitoCareX will conduct its ongoing and planned preclinical studies and clinical trials and potentially seeks regulatory approval for its ACSMT and any future ACSMT MitoCareX may develop. If MitoCareX obtains regulatory approval for ACSMT, the Company expects that MitoCareX’s to incur significant commercialization expenses related to product manufacturing, marketing, sales, and distribution. Because the outcome of any preclinical study or clinical trial is highly uncertain, MitoCareX cannot reasonably estimate the actual amount of capital necessary to successfully complete the development and commercialization of ACSMT.
The Company will need to obtain substantial additional funding to support MitoCareX’s continuing operations. The ability to raise additional funds may be adversely impacted by global economic conditions, disruptions to, and volatility in, the credit and financial markets in the United States, inflation, diminished liquidity and credit availability, declines in consumer confidence, declines in economic growth, increases in unemployment rates, and uncertainty about economic stability. If the equity and credit markets deteriorate, it may make any necessary debt or equity financing by the Company more difficult, more costly, and more dilutive. If additional capital cannot be raised when needed or on attractive terms, the Company could be forced to delay, reduce, or eliminate MitoCareX’s research and development programs or any future commercialization efforts, or even cease operations.
The Company may also seek to finance MitoCareX’s operations through public or private equity or debt financings or other capital sources of MitoCareX, including potential collaborations, licenses, and other similar arrangements involving MitoCareX. Such transactions could include the issuance of new equity interests in MitoCareX to third parties, which may dilute the Company’s ownership and/or the value of its investment in MitoCareX.
Its future capital requirements will depend on many factors, including, but not limited to:
● the initiation, type, number, scope, progress, expansions, results, costs, and timing of preclinical studies and clinical trials of ACSMT that MitoCareX is pursuing or may choose to pursue in the future, including the costs of any third-party products used as combination agents in its clinical trials; the costs and timing of manufacturing for ACSMT, including commercial manufacturing at sufficient scale, if any ACSMT is approved;
● the costs, timing, and outcome of regulatory meetings and reviews of ACSMT;
● the costs of obtaining, maintaining, enforcing, and protecting its patents and other intellectual property and proprietary rights;
● the costs associated with hiring additional personnel and consultants as its preclinical and clinical activities begin and increase;
● the costs and timing of establishing or securing sales and marketing capabilities if ACSMT is approved;
● its ability to achieve sufficient market acceptance, coverage, and adequate reimbursement from third-party payors and adequate market share and revenue for any approved products;
● patients’ willingness to pay out-of-pocket for any approved products in the absence of coverage and/or adequate reimbursement from third-party payors;
● the terms and timing of establishing and maintaining collaborations, licenses, and other similar arrangements; and
● costs associated with any products or technologies that MitoCareX may in-license or acquire.
Conducting preclinical studies and clinical trials and discovering additional potential ACSMT is a time-consuming, expensive, and uncertain process that takes years to complete, and MitoCareX may never generate the necessary data or results required to obtain regulatory approval and commercialize ACSMT. In addition, ACSMT, if approved, may not achieve commercial success. Its commercial revenue, if any, will initially be derived from sales of products that MitoCareX does not expect to be commercially available for many years, if at all.
Accordingly, MitoCareX will need to continue to rely on additional financing to achieve its business objectives. Adequate additional financing may not be available to MitoCareX on acceptable terms, or at all, including as a result of financial and credit market deterioration or instability, market-wide liquidity shortages, geopolitical events, or otherwise.
Raising additional capital may restrict MitoCareX’s operations, or require it to relinquish rights to its ACSMT or other technologies.
If the Company raises additional funds through future collaborations, licenses, and other similar arrangements, it may be required to cause its subsidiary, MitoCareX, to relinquishvaluable rights to MitoCareX’s future revenue streams, ACSMT, intellectual property, or proprietary technology, or grant licenses on terms that may not be favorable to the Company and/or that may reduce the value of its common stock. If the Company is unable to raise additional funds through equity or debt financings or other arrangements when needed or on terms acceptable to it, the Company may be required to delay, limit, reduce, or terminate the product development or future commercialization efforts of MitoCareX, or grant rights to develop and market ACSMT that MitoCareX might otherwise prefer to develop and market itself, or on less favorable terms than would otherwise be chosen.
MitoCareX is early in its development efforts. All of its ACSMT programs are still in the preclinical or discovery stage. Its MITOLINE™ algorithm requires further validations and optimizations. If MitoCareX is unable to successfully develop, obtain regulatory approval, and ultimately commercialize any current or future ACSMT or its MITOLINE™ algorithm, or experience significant delays in doing so, its business will be materially harmed.
MitoCareX is early in its development. All ACSMT programs are still in the development stage. MitoCareX has invested substantially most of its efforts to date in developing ACSMT, identifying other potential targets for therapeutic pursuit, and continuing to develop its proprietary MITOLINE™ algorithm. MitoCareX will need to progress through first-in-human clinical trials and progress its other ACSMT programs through additional preclinical studies to enable it to submit INDs to the FDA and receive allowance from the FDA to proceed with initiating their clinical development. Its ability to generate product revenue will depend heavily on the successful development and eventual commercialization of ACSMT. MitoCareX does not expect this to occur for many years, if ever. The success of ACSMT will depend on several factors, including the following:
● successful initiation and enrollment of clinical trials, and timely completion of hit-to-lead development of its ACSMT, preclinical studies and clinical trials with favorable results;
● allowance to proceed with clinical trials for ACSMT under INDs by the FDA, or under similar regulatory submissions by comparable foreign regulatory authorities;
● the frequency and severity of adverse events observed in clinical trials and preclinical studies;
● maintaining and establishing relationships with contract research organizations (CROs) and clinical sites for the clinical development of ACSMT, and ability of such CROs and clinical sites to comply with clinical trial protocols, Good Clinical Practice requirements (GCPs) and other applicable requirements;
● demonstrating the safety and efficacy of ACSMT to the satisfaction of applicable regulatory authorities, including by establishing a safety database of a size satisfactory to regulatory authorities;
● successful development, validation, and regulatory approval of companion diagnostic tests for use in patient selection with ACSMT, if required;
● receipt of regulatory approvals from applicable regulatory authorities, including approvals of new drug applications (NDAs), from the FDA and maintaining such approvals;
● maintaining relationships with its third-party manufacturers and their ability to comply with current Good Manufacturing Practice requirements (cGMPs) as MitoCareX will be making arrangements with its third-party manufacturers for, or establishing its own, commercial manufacturing capabilities at a cost and scale sufficient to support commercialization;
● establishing sales, marketing, and distribution capabilities and launching commercial sales of its products, if and when approved, whether alone or in collaboration with others;
● obtaining, maintaining, protecting, and enforcing any patent and trade secret protection, patent term extensions (if applicable) and/or regulatory exclusivity for ACSMT;
● maintaining an acceptable safety profile of its products following regulatory approval, if any;
●maintaining and growing an organization of people who can develop and commercialize its products; and
● acceptance of its products, if approved, by patients, the medical community, and third-party payors.
If MitoCareX is unable to develop, obtain regulatory approval for, or, if approved, successfully commercialize ACSMT, or if MitoCareX experience delays as a result of any of the above factors or otherwise, its business would be materially harmed.
Risks Related to Intellectual Property
If we are unable to secure and maintain patent or other intellectual property protection for our products, our ability to compete may be harmed.
Our commercial success depends, in part, on obtaining and maintaining patent and other intellectual property protection for the proprietary blend used in our products and our manufacturing process, as well as continuing to develop and secure trade secrets. We might in the future opt to license intellectual property from other parties. If we, or the other parties from whom we may license intellectual property, fail to obtain and maintain adequate patent or other intellectual property protection for intellectual property used in our products, or if any protection is reduced or eliminated, others could use the intellectual property used in our products, resulting in harm to our competitive business position. In addition, patent and other intellectual property protection may not provide us with a competitive advantageagainst competitors that devise ways of making competitive products without infringing any patents that we own or to which we have rights.
U.S. patents and patent applications may be subject to interference proceedings, and U.S. patents may be subject to re-examination proceedings in the U.S. Patent and Trademark Office. Foreign patents may be subject to opposition or comparable proceedings in the corresponding foreign patent offices. Any of these proceedings could result in loss of the patent or denial of the patent application, or loss or reduction in the scope of one or more of the claims of the patent or patent application. Changes in either patent laws or in interpretations of patent laws may also diminish the value of our intellectual property or narrow the scope of our protection. Interference, re-examination and opposition proceedings may be costly and time consuming, and we, or the other parties from whom we might potentially license intellectual property, may be unsuccessful in defendingagainst such proceedings. Thus, any patents that we own or might license may provide limited or no protection against competitors. In addition, our pending patent applications and those we may file in the future may have claims narrowed during prosecution or may not result in patents being issued. Even if any of our pending or future applications are issued, they may not provide us with adequate protection or any competitive advantages. Our ability to develop additional patentable technology is also uncertain.
Non-payment or delay in payment of patent fees or annuities, whether intentional or unintentional, may also result in the loss of patents or patent rights important to our business. Many countries, including certain countries in Europe, have compulsory licensing laws under which a patent owner may be compelled to grant licenses to other parties. In addition, many countries limit the enforceability of patents against other parties, including government agencies or government contractors. In these countries, the patent owner may have limited remedies, which could materially diminish the value of the patent. In addition, the laws of some foreign countries do not protect intellectual property rights to the same extent as do the laws of the United States.
If we are unable to prevent unauthorized use or disclosure of our proprietary trade secrets and unprotected know-how, our ability to compete may be harmed.
Proprietary trade secrets, copyrights, trademarks, and unprotected know-how are also very important to our business. We rely on a combination of trade secrets, copyrights, trademarks, confidentiality agreements and other contractual provisions and technical security measures to protect certain aspects of our technology, especially where we do not believe that patent protection is appropriate or obtainable. We require our office holders, employees, consultants, and distributors of our products and most third parties to execute confidentiality agreements in connection with their relationships with us. However, these measures may not be adequate to safeguard our proprietary intellectual property and conflicts may, nonetheless, arise regarding ownership of inventions. Such conflicts may lead to the loss or impairment of our intellectual property or to expensive litigation to defend our rights against competitors who may be better funded and have superior resources. Our office holders, employees, consultants, and other advisors may unintentionally or willfullydisclose our confidential information to competitors. In addition, confidentiality agreements may be unenforceable or may not provide an adequate remedy in the event of unauthorized disclosure. Enforcing a claim that a third party illegally obtained and is using our trade secrets is expensive and time consuming, and the outcome is unpredictable. Moreover, our competitors may independently develop equivalent knowledge, methods, and know-how. Unauthorized parties may also attempt to copy or reverse engineer certain aspects of our products that we consider proprietary. As a result, other parties may be able to use our proprietary technology or information, and our ability to compete in the market may be harmed.
We could become subject to patent and other intellectual property litigation that could be costly, result in the diversion of management’s attention, require us to pay damages and force us to discontinue selling our products.
Determining whether a product infringes a patent involves complex legal and factual issues, and the outcome of a patent litigation action is often uncertain. No assurance can be given that patents containing claims covering our products, parts of our products, technology or methods do not exist, have not been filed or could not be filed or issued. Furthermore, our competitors or other parties may assert that our products and the methods we employ in the use of our products are covered by U.S. or foreign patents held by them. In addition, because patent applications can take many years to issue and because publication schedules for pending applications vary by jurisdiction, there may be applications now pending of which we are unaware, and which may result in issued patents which our current or future products infringe. Also, because the claims of published patent applications can change between publication and patent grant, there may be published patent applications with claims that we infringe. There could also be existing patents that one or more of our products or parts may infringe and of which we are unaware. As the number of competitors in the post-harvest market grows, and as the number of patents issued grows, the possibility of patent infringementclaimsagainst us increases.
Infringement actions and other intellectual property claims and proceedings brought against or by us, whether with or without merit, may cause us to incur substantial costs and could place a significant strain on our financial resources, divert the attention of management from our business and harm our reputation. Some of our competitors may be able to sustain the costs of complex patent or intellectual property litigation more effectively than we can because they have substantially greater resources.
We cannot be certain that we will successfullydefendagainstallegations of infringement of patents and intellectual property rights of others. In the event that we become subject to a patent infringement or other intellectual property lawsuit and if the other party’s patents or other intellectual property were upheld as valid and enforceable and we were found to infringe the other party’s patents or violate the terms of a license to which we are a party, we could be required to pay damages. We could also be prevented from selling our products unless we could obtain a license to use technology or processes covered by such patents or will be able to redesign the product to avoid infringement. A license may not be available at all or on commercially reasonable terms or we may not be able to redesign our products to avoid infringement. Modification of our products or development of new products could require us to conduct clinical trials and to revise our filings with the applicable regulatory bodies, which would be time-consuming and expensive. In these circumstances, we may be unable to sell our products at competitive prices or at all, our business and operating results could be harmed.
We may be subject to claimschallenging the inventorship or ownership of our patents and other intellectual property.
We may be subject to claims that former employees, collaborators, or other third parties have an ownership interest in our patents or other intellectual property. Ownership disputes may arise in the future, for example, from conflicting obligations of consultants or others who are involved in developing our product candidates. Litigation may be necessary to defendagainst these and other claimschallenging inventorship or ownership. If we fail in defending any such claims, in addition to paying monetary damages, we may losevaluable intellectual property rights, such as exclusive ownership of, or right to use, valuable intellectual property. Such an outcome could have a material adverse effect on our business. Even if we are successful in defendingagainst such claims, litigation could result in substantial costs and be a distraction to management and other employees.
We may experience claims that our products infringe the intellectual property rights of others, which may cause us to incur unexpected costs or prevent us from selling our products or services.
We continually seek to improve our business processes and develop new products and applications in a crowded patent space that we must continually monitor to avoid infringement. We cannot guarantee that we will not experience claims that our processes and products infringe issued patents (whether present or future) or other intellectual property rights belonging to others.
From time to time, we oppose patent applications that we consider overbroad or otherwise invalid in order to maintain the ability to operate freely in our various business lines without the risk of being sued for patent infringement. If, however, patents are subsequently issued on any such applications by other parties, or if patents belonging to others already exist that cover our products, processes or technologies, we could experience claims for infringement or have to take other remedial or curative actions to continue our manufacturing and sales activities with respect to one or more products. Likewise, our competitors may also already hold or have applied for patents in the United States or abroad that, if enforced or issued, could prevail over our patent rights or otherwise limit our ability to manufacture or sell one or more of our products in the United States or abroad. Any actions asserted against us could require payment of damages for infringement, enjoining the use of said product, or a requirement that we obtain licenses from these parties or substantially re-engineer our products or processes in order to avoid infringement. We may not be able to obtain the necessary licenses on acceptable terms, or at all, or be able to re-engineer our products successfully. Further, intellectual property litigation is expensive and time-consuming, regardless of the merits of any claim, and could divert our management’s attention from operating our business.
Risks Related to Regulatory Compliance
If we or our contractors or service providers fail to comply with laws and regulations, we or they could be subject to regulatory actions, which could affect our ability to develop, market and sell our products or future products that we may develop and may harm our reputation in our industry.
If we or our manufacturers or other third-party contractors fail to comply with applicable federal, state or foreign laws or regulations, including with respect to food treatment, we could be subject to regulatory actions, which could affect our ability to develop, market and sell our current products or any future products which we may develop in the future and could harm our reputation and lead to reduced demand for or non-acceptance of our proposed products by the market.
Regulatory reforms may adversely affect our ability to sell our products profitably.
From time to time, legislation is drafted and introduced in the United States, Mexico, Israel or other countries in which we operate, that could significantly change the statutory provisions governing the clearance or approval, manufacture and marketing of our products, including in the food health industry. In addition, regulations and guidance may often be revised or reinterpreted by the regulatory authorities in ways that may significantly affect our business and our products. It is impossible to predict whether legislative changes will be enacted, or interpretations changed, and what the impact of such changes, if any, may be.
Risks Related to Our Investment in Solar Energy
Our investment in the solar energy sector is both for strategic and financial reasons but we may not realize a return on our investments.
We have made, and continue to seek to make, investments in the solar energy sector, by and through our collaboration with Solterra, which we believe furthers our strategic objectives and supports our business initiatives. We have thus far invested in certain PV Projects in Europe and do not restrict ourselves from pursuing additional investments in the solar energy sector. If any project in which we invest fails, we could lose all or part of our investment in that project. If we determine that an other-than-temporary decline in the fair value exists for any such investment, we will have to write down the investment to its fair value and recognize the related write-down as an investment loss. The performance of any of these investments could result in significant impairment charges and gains (losses) on other equity investments. We must also analyze accounting and legal issues when making these investments. If we do not structure these investments properly, we may be subject to certain unfavorable accounting impact, such as potential consolidation of financial results. Furthermore, if the strategic objectives of an investment have been achieved, or if the investment diverges from our strategic objectives, we may seek to dispose of the investment. The occurrence of any of these events could harm our results.
Climate-Related Risks May Adversely Affect Solterra’s Business and Our Joint Venture Value
Solterra’s renewable energy power generation is subject to climate conditions, which could materially and adversely affect its business and, in turn, the value of our joint venture. The ability to generate electricity using PV technology and the revenue from electricity sales are significantly impacted by weather conditions. PV plant output depends on sunlight intensity and other climate parameters, such as sunshine hours, temperature, atmospheric pressure, and wind patterns. Extensive cloud cover, wind, humidity, temperatures significantly different from the annual average, and extreme weather changes may reduce electricity generation, impacting revenue and profitability. Unpredictable natural disasters, such as floods, sandstorms, and earthquakes, may cause shutdowns and damage constructed PV Projects, affecting their operational lifespan and profitability. Any adverse impact on Solterra’s business could negatively affect the value of our joint venture.
Regulatory and Compliance Changes May Adversely Impact Solterra’s Operations and Our Joint Venture Value
The renewable energy sector is highly regulated. Solterra’s PV projects are subject to various laws and regulations in the jurisdictions where Solterra operates, including those related to permitting, licensing, incentives, tariffs, and electricity pricing. Changes in these laws and regulations, or Solterra’s failure to comply with them, could have a material adverse effect on its business, financial condition and results of operations, which could in turn negatively affect the value of our joint venture.
Permitting and Licensing Delays May Impact Solterra’s Project Timelines and Our Joint Venture Value
The construction and operation of renewable energy projects require permits, subject to the nature and scope of the activity. Solterra’s PV projects are subject to approvals and permits from regulatory bodies and authorities in its countries of operation. There is no assurance that all necessary permits and approvals for Solterra’s PV projects will be granted, whether conditionally or unconditionally, or in a timely manner, potentially causing delays in PV project timelines and impacting their feasibility. Delays or failure to obtain necessary permits could negatively affect Solterra’s business and, in turn, the value of our joint venture.
Fluctuations in Electricity Tariffs May Impact Solterra’s Revenue and Our Joint Venture Value
Electricity tariffs significantly impact Solterra’s revenue and profitability. Solterra’s facilities are designed to connect to electricity grids in various countries, sometimes at a tariff set by relevant regulations or exposed to fluctuating market electricity prices. A decrease in tariffs paid for renewable energy generation, especially solar energy, may negatively affect Solterra’s revenue and profitability. Any decline in Solterra’s revenue or profitability could negatively affect the value of our joint venture.
Supply Chain and Contractor Disruptions May Delay Solterra’s Projects and Affect Our Joint Venture Value
Solterra’s projects rely on the timely delivery of equipment and materials and the performance of contractors and subcontractors. Disruptions to supply lines, closure or shutdown of airports and/or ports due to security, health, strikes, or other events may lead to disruptions in the supply chain of various PV Project components, consequently delaying their construction or required maintenance. Furthermore, termination of agreements with contractors and/or subcontractors, or changes in the costs of their services, could lead to project delays, increased costs, and failure to meet timelines, potentially impacting the economic feasibility of PV projects. Any of these issues could negatively affect Solterra’s business and, in turn, the value of our joint venture.
Equipment Malfunctions and Downtime May Impact Solterra’s Operations and Our Joint Venture Value
Solterra’s future revenue depends, among other things, on the proper functioning of its projects and electricity generation. Malfunctions in Solterra’s facilities and PV projects may result from product use and wear, as well as from terrorism, sabotage, accidents, theft, fires, earthquakes, extreme climate changes, natural disasters, and other unexpectedadversities. These issues, as well as the need for Solterra to provide services following events requiring equipment repair and/or replacement, may cause delays in project timelines and incur significant additional costs. Any significant equipment malfunction or project downtime could negatively affect Solterra’s business and, in turn, the value of our joint venture.
Intense Competition in the Renewable Energy Sector May Affect Solterra’s Market Share and Our Joint Venture Value
The renewable energy sector is highly competitive. Solterra faces competition from various companies in the renewable energy sector, some of which are large and well-established. Increased competition could negatively impact Solterra’s market share, business, revenue, and cash flow. This increased competition could also affect the value of our joint venture.
Joint Venture and Partnership Risks May Affect Solterra’s Projects and Our Joint Venture Value
Solterra engages in joint ventures and other collaborations with partners for certain projects. Disputes or the financial difficulties of a partner could negatively affect Solterra’s PV projects and its financial results, which could in turn negatively affect the value of our joint venture.
Safety and Operational Risks May Impact Solterra’s Business and Our Joint Venture Value
The activities performed by Solterra through external contractors involve safety risks. Workplace accidents may expose workers and subcontractors’ employees to physical and psychological harm and loss of earning capacity. Although Solterra requires contractors to implement necessary safety measures, this does not precludeaccidents. Insurance policies may not fully cover damages, potentially leading to significant expenses for Solterra. Any significant safety incidents or operational issues could negatively affect Solterra’s business and, in turn, the value of our joint venture.
Risks Related to Our Operations in Israel
Conditions in Israel and regional instability may adversely affect our operations.
All of our employees, including our management team, operate from locations in Israel. In addition, all of our directors are residents of Israel. Accordingly, military, political, and economic conditions in Israel may directly affect our business.
Israel has experienced, and may in the future experience, armed conflicts, terrorist activity, civil unrest, and political instability, which could disrupt our operations and supply chain. Such conditions may result in the call-up of our employees for military reserve duty for extended periods, reducing workforce availability. Armed conflict or terrorist activity may cause physical damage to our facilities or to public infrastructure, utilities, and telecommunications networks in Israel, and Israeli companies may face heightened cybersecurity threats during periods of regional tension. These disruptions could lead to increased operating costs, challenges to business continuity, risks to employee safety, and difficulties in delivering products and services in a timely manner. In addition, counterparties to our agreements may assert force majeure claims based on security conditions in Israel, which could affect our ability to meet contractual obligations or enforce the obligations of others.
Regional instability and armed conflict may have broader adverse effects on economic and financial conditions in Israel, including effects on credit markets, currency valuation, inflation, and labor markets. Prolongedconflicts have in the past required significant mobilization of military reservists, including personnel employed in the sector in which we operate, which may affect workforce availability across the industry. Such conditions may also result in credit rating changes for Israel, which could adversely affect access to capital and general business conditions.
Our commercial insurance does not cover losses resulting from war or terrorist attacks. While the Israeli government has in the past provided compensation for certain damages caused by such events, we cannot assure you that such government compensation programs will continue, or if continued, will be sufficient to compensate us fully for any losses incurred. As of the date of this report, the impact of regional security conditions on our results of operations and financial condition has not been material; however, such impact could increase and may become material if conditions deteriorate. Any significant losses or damages incurred by our Israeli operations as a result of armed conflict, terrorist activity, or related instability could have a material adverse effect on our business, financial condition, and results of operations.
We may not be able to enforce covenants not-to-compete under current Israeli law that might result in added competition for our products.
We have non-competition agreements with all of our employees, all of which are governed by Israeli law. These agreements prohibit our employees from competing with or working for our competitors, generally during their employment and for up to 12 months after termination of their employment. However, Israeli courts are reluctant to enforce non-compete undertakings of former employees and tend, if at all, to enforce those provisions for relatively brief periods of time in restricted geographical areas, and only when the employee has obtained unique value to the employer specific to that employer’s business and not just regarding the professional development of the employee. If we are not able to enforce non-compete covenants, we may be faced with added competition.
It may be difficult to acquire jurisdiction and enforce liabilities against our officers and directors who are based in Israel.
All of our officers and directors reside outside of the United States and most of our operations are located outside the United States. As a result, it may not be possible for United States investors to enforce their legal rights, to effect service of process upon our directors or officers or to enforce judgments of United States courts predicated upon civil liabilities and criminalpenalties of our directors and officers under federal securities laws. Moreover, we have been advised that Israel does not have treaties providing for the reciprocal recognition and enforcement of judgments of courts with the United States. Further, it is unclear if extradition treaties now in effect between the United States and Israel would permit effective enforcement of criminalpenalties of the federal securities laws.
Risks Related to Ownership of Our Common Stock
The market price of our common stock may be highly volatile.
The market price of our common stock is likely to be volatile. Our common stock price could be subject to wide fluctuations in response to a variety of factors, including the following:
reports of adverse events with respect to the commercialization and distribution of our products;
inability to obtain additional funding;
failure to successfully develop and commercialize our products;
failure to enter into strategic collaborations;
failure by our company or strategic collaboration partners to prosecute, maintain or enforce our intellectual property rights;
changes in laws or regulations applicable to future products;
inability to scale up our manufacturing capabilities through third-party manufacturers, inability to obtain adequate product supply for our products or the inability to do so at acceptable prices;
introduction of new products or technologies by our competitors;
failure to meet or exceed financial projections we may provide to the public;
failure to meet or exceed the financial expectations of the investment community;
announcements of significant acquisitions, strategic partnerships, joint ventures or capital commitments by our competitors;
disputes or other developments relating to proprietary rights, including patents, litigation matters and our ability to obtain patent protection for our platform technologies, technologies, products or product candidates;
additions or departures of key scientific or management personnel;
significant lawsuits, including patent or stockholder litigation;
changes in the market valuations of similar companies;
sales of our securities by us or our stockholders in the future; and
trading volumes of our securities.
In addition, companies trading in the stock market have experienced extreme price and volume fluctuations that have often been unrelated or disproportionate to the operating performance of these companies. Broad market and industry factors may negatively affect the market price of our common stock, regardless of our actual operating performance.
Sales of a substantial number of shares of our common stock in the public market by our existing stockholders could cause our share price to fall.
Sales of a substantial number of shares of our common stock in the public market, or the perception that these sales might occur, could depress the market price of our common stock and could impair our ability to raise capital through the sale of additional equity securities. We are unable to predict the effect that sales may have on the prevailing market price of our common stock.
We may need additional capital, and the sale of additional shares or equity or debt securities could result in additional dilution to our stockholders.
We may require additional cash resources due to changed business conditions or other future developments, including adverse effects to our business from global inflation and recession related issues. If these resources are insufficient to satisfy our cash requirements, we may seek to sell additional equity or debt securities or obtain one or more credit facilities. The sale of additional equity securities could result in additional dilution to our stockholders. The incurrence of indebtedness would result in increased debt service obligations and could result in operating and financing covenants that would restrict our operations. It is uncertain whether financing will be available in amounts or on terms acceptable to us, if at all.
Nevada law and provisions in our articles of incorporation and bylaws could make a merger, tender offer or proxy contest difficult, thereby depressing the market price of our common stock.
Our status as a Nevada corporation and the anti-takeover provisions of the Nevada Revised Statutes may discourage, delay or prevent a change in control by prohibiting us from engaging in a business combination with an interested stockholder for a period of three years after the date of the transaction in which the person became an interested stockholder, even if a change of control would be beneficial to our existing stockholders. In addition, our articles of incorporation and bylaws contain provisions that may make the acquisition of our company more difficult, including the following:
our stockholders will only be able to take action at a meeting of stockholders and will not be able to take action by written consent for any matter;
our board of directors is classified into three classes of directors with staggered three-year terms;
a special meeting of our stockholders may only be called by a majority of our board of directors;
advance notice procedures apply for stockholders to nominate candidates for election as directors or to bring matters before an annual meeting of stockholders; and
certain litigationagainst us can only be brought in Nevada.
These provisions, alone or together, could discourage, delay or prevent a transaction involving a change in control of our company. These provisions could also discourage proxy contests and make it more difficult for stockholders to elect directors of their choosing and to cause us to take other corporate actions they desire, any of which, under certain circumstances, could limit the opportunity for our stockholders to receive a premium for their shares of our common stock, and could also affect the price that some investors are willing to pay for our common stock.
If we fail to comply with the continued listing requirements of the Nasdaq Capital Market, our common stock may be delisted and the price of our common stock and our ability to access the capital markets could be negatively impacted.
Nasdaq has established certain standards for the continued listing of a security on the Nasdaq Capital Market. The standards for continued listing include, among other things, that the minimum bid price for the listed securities not fall below $1.00 per share for a period of 30 consecutive trading days and that we maintain a minimum of $2,500,000 in shareholders’ equity.
We have in the past fallen out of compliance with certain continued listing standards including the minimum bid price requirement although we have subsequently been able to regain compliance. No assurance however can be given that we will continue to be in compliance with the continued listing requirements of the Nasdaq Capital Market. Failure to meet applicable Nasdaq continued listing standards could result in a delisting of our common stock. A delisting of our common stock from Nasdaq could materially reduce the liquidity of our common stock and result in a corresponding material reduction in the price of our common stock. In addition, delisting could harm our ability to raise capital through alternative financing sources on terms acceptable to us, or at all, and may result in the potential loss of confidence by investors, employees and fewer business development opportunities.
We may be subject to securities litigation, which is expensive and could divert management attention.
In the past, companies that have experienced volatility in the market price of their stock have been subject to securities class action litigation. We may be the target of this type of litigation in the future. Litigation of this type could result in substantial costs and diversion of management’s attention and resources, which could seriouslyhurt our business. Any adverse determination in litigation could also subject us to significant liabilities.
If securities or industry analysts do not publish or cease publishing research or reports about us, our business or our market, or if they adversely change their recommendations or publish negative reports regarding our business or our common stock, our stock price and trading volume could decline.
The trading market for our common stock will be influenced by the research and reports that industry or securities analysts may publish about us, our business, our market or our competitors. We do not have any control over these analysts and we cannot provide any assurance that analysts will cover us or provide favorable coverage. If any of the analysts who may cover us adversely change their recommendation regarding our shares, or provide more favorable relative recommendations about our competitors, our stock price would likely decline. If any analysts who may cover us were to cease coverage of our company or fail to regularly publish reports on us, we could lose visibility in the financial markets, which in turn could cause our stock price or trading volume to decline.
We do not anticipate paying any cash dividends in the foreseeable future.
We have never declared or paid cash dividends, and we do not anticipate paying cash dividends in the foreseeable future. Therefore, you should not rely on an investment in our common stock as a source for any future dividend income. Our board of directors has complete discretion as to whether to distribute dividends. Even if our board of directors decides to declare and pay cash dividends, the timing, amount and form of future dividends, if any, will depend on our future results of operations and cash flow, our capital requirements and surplus, the amount of distributions, if any, received by us from our subsidiary, our financial condition, contractual restrictions and other factors deemed relevant by our board of directors.
General Risk Factors
Disruptions to our information technology systems due to cyber-attacks or our failure to upgrade and adjust our information technology systems, may materially impair our operations, hinder our growth and materially and adversely affect our business and results of operations.
We believe that an appropriate information technology (“IT”), infrastructure is important in order to support our daily operations and the growth of our business. If we experience difficulties in implementing new or upgraded information systems or experience significant system failures, or if we are unable to successfully modify our management information systems or respond to changes in our business needs, we may not be able to effectively manage our business, and we may fail to meet our reporting obligations. Additionally, if our current back-up storage arrangements and our disaster recovery plan are not operated as planned, we may not be able to effectively recover our information system in the event of a crisis, which may materially and adversely affect our business and results of operations.
In the current environment, there are numerous and evolving risks to cybersecurity and privacy, including criminal hackers, hacktivists, state-sponsored intrusions, industrial espionage, employee malfeasance and human or technological error. High-profile security breaches at other companies and in government agencies have increased in recent years, and security industry experts and government officials have warned about the risks of hackers and cyber-attacks targeting businesses such as ours. Computer hackers and others routinely attempt to breach the security of technology products, services and systems, and to fraudulently induce employees, customers, or others to disclose information or unwittingly provide access to systems or data. Since the beginning of the war between Israel and Hamas which began on October 7, 2023, Israeli and Israeli associated companies have become more frequently the target of cyberattacks. As such, the risk of a cyberattackagainst our IT systems may become heightened. We can provide no assurance that our current IT system or any updates or upgrades thereto and the current or future IT systems of our distributors use or may use in the future, are fully protected against third-party intrusions, viruses, hacker attacks, information or data theft or other similar threats. Legislative or regulatory action in these areas is also evolving, and we may be unable to adapt our IT systems or to manage the IT systems of third parties to accommodate these changes. We have experienced and expect to continue to experience actual or attempted cyber-attacks on our IT networks. Although none of these actual or attempted cyber-attacks has had a material adverse impact on our operations or financial condition, we cannot guarantee that any such incidents will not have such an impact in the future.
Failure to comply with anti-bribery, anti-corruption and anti-money laundering laws could subject us to penalties and other adverse consequences.
We are subject to the FCPA and other anticorruption, anti-bribery and anti-money laundering laws in the jurisdictions in which we do business, both domestically and abroad. These laws generally prohibit us and our employees from improperly influencing government officials or commercial parties in order to obtain or retain business, direct business to any person or gain any advantage. The FCPA and other applicable anti-bribery and anti-corruption laws also may hold us liable for acts of corruption and bribery committed by our third-party business partners, representatives and agents. In addition, we leverage third parties to sell our products and conduct our business abroad. We and our third-party business partners, representatives and agents may have direct or indirect interactions with officials and employees of government agencies or state-owned or affiliated entities and we may be held liable for the corrupt or other illegal activities of these third-party business partners and intermediaries, our employees, representatives, contractors, channel partners and agents, even if we do not explicitly authorize such activities. These laws also require that we keep accurate books and records and maintain internal controls and compliance procedures designed to prevent any such actions. While we have policies and procedures to address compliance with such laws, we cannot assure you that our employees and agents will not take actions in violation of our policies or applicable law, for which we may be ultimately held responsible and our exposure for violating these laws increases as our international presence is established and as we increase sales and operations in foreign jurisdictions. Any violation of the FCPA or other applicable anti-bribery, anti-corruption laws and anti-money laundering laws could result in whistleblower complaints, adverse media coverage, investigations, imposition of significant legal fees, loss of export privileges, severecriminal or civil sanctions or suspension or debarment from U.S. government contracts, substantial diversion of management’s attention, a decline in the market price of our common stock or overall adverse consequences to our reputation and business, all of which may have an adverse effect on our results of operations and financial condition.
We incur additional increased costs as a result of the listing of our common stock for trading on Nasdaq, and our management is required to devote substantial time to new compliance initiatives and reporting requirements.
As a public company, we incur significant accounting, legal and other expenses as a result of the listing of our common stock on Nasdaq. These include costs associated with corporate governance requirements of the Securities Exchange Commission, or the SEC, and the Marketplace Rules of Nasdaq, as well as requirements under Section 404 and other provisions of the Sarbanes-Oxley Act of 2002, or the Sarbanes-Oxley Act. These rules and regulations increase our legal and financial compliance costs, introduce costs such as investor relations, stock exchange listing fees and stockholder reporting, and make some activities more time consuming and costly. Any future changes in the laws and regulations affecting public companies in the United States, including Section 404 and other provisions of the Sarbanes-Oxley Act, the rules and regulations adopted by the SEC and the rules of the Nasdaq Stock Market may result in increased costs to our company as we respond to such changes. These laws, rules and regulations could make it more difficult or more costly for us to obtain certain types of insurance, including director and officer liability insurance, and we may be forced to accept reduced policy limits and coverage or incur substantially higher costs to obtain the same or similar coverage. The impact of these requirements could also make it more difficult for us to attract and retain qualified persons to serve on our board of directors, our board committees or as executive officers.
We face risks related to compliance with corporate governance laws and financial reporting standards.
The Sarbanes-Oxley Act of 2002, as well as related rules and regulations implemented by the SEC and the Public Company Accounting Oversight Board, require changes in the corporate governance practices and financial reporting standards for public companies. These laws, rules and regulations, including compliance with Section 404 of the Sarbanes-Oxley Act of 2002 relating to internal control over financial reporting, have materially increased the legal and financial compliance costs of small companies and have made some activities more time-consuming and more burdensome.
The ongoing conflict in Ukraine may result in market volatility that could adversely affect our business.
In late February 2022, Russia invaded Ukraine, significantly amplifying already existing geopolitical tensions among Russia and other countries in the region and in the west, including the U.S. Russia’s invasion, the responses of countries and political bodies to Russia’s actions, the larger overarching tensions, and Ukraine’s military response and the potential for wider conflict may increase financial market volatility and could have severeadverse effects on regional and global economic markets. The foregoing may adversely affect our customers’ ability to sell produce to Russia or other countries in the geographic vicinity.
Following Russia’s actions, various countries, including the U.S., Canada, the United Kingdom, Germany and France, as well as the European Union, issued broad-ranging economic sanctions against Russia. Such sanctions included, among other things, a prohibition on doing business with certain Russian companies, officials and oligarchs; a commitment by certain countries and the European Union to remove selected Russian banks from the Society for Worldwide Interbank Financial Telecommunications electronic banking network that connects banks globally; and restrictive measures to prevent the Russian Central Bank from undermining the impact of the sanctions. To date the ongoing conflict has not affected our financial condition, yet the current sanctions (and potential further sanctions in response to continued Russian military activity) and other actions may have adverse effects on regional and global economic markets, and may result in increased volatility in the price of our common stock.
If we fail to implement and maintain effective internal control over financial reporting, we may be unable to report our financial results accurately or meet our reporting obligations.
The process of determining whether our existing internal controls over financial reporting systems are compliant with Section 404(a) and whether there are any material weaknesses or significant deficiencies in our existing internal controls requires the investment of substantial time and resources, including by our Chief Executive Officer, Chief Financial Officer and other members of our senior management and finance team. This determination and any remedial actions required could divert internal resources and take a significant amount of time and effort to complete and could result in our company incurring additional costs that we did not anticipate, including the hiring of outside consultants. We could experience higher than anticipated operating expenses and higher independent auditor fees during and after the implementation of these changes.
Irrespective of compliance with Section 404, any failure of our internal controls could have a material adverse effect on our stated results of operations and harm our reputation. If we identify future material weaknesses in our internal control of financial reporting, and if we are unable to implement any of the required changes to our internal control over financial reporting effectively or efficiently or are required to do so earlier than anticipated, it could adversely affect our operations, financial reporting and/or results of operations and could result in an adverse opinion on internal controls from our management and, once we lose our emerging growth company status, our independent auditors. Further, if our internal control over financial reporting is not effective, the reliability of our financial statements may be questioned, and our share price may suffer.
advancement
During 2025, the Company underwent significant changes to its business operations. In April 2025, the Company completed the sale of its NTWO OFF Ltd. operations. In addition, during 2025, the Company classified its Save Foods operations as held for sale and discontinued operations. Accordingly, the results of these operations are presented separately in the consolidated financial statements and are not included in the discussion of continuing operations below.
As a result of these changes, the Company’s consolidated financial statements for the periods presented have been reclassified to conform to the current presentation, and therefore may not be directly comparable to prior periods. Unless otherwise indicated, the discussion below relates to the Company’s continuing operations.
Recent Developments
Save Foods Transaction
On January 13, 2026, we entered into the SF Agreement with Voice Assist. Pursuant to the SF Agreement, at the Closing we transferred to Voice Assist all of the ordinary shares of Save Foods owned by us, representing approximately 98% of the issued and outstanding share capital of Save Foods (the “SF Shares”), free and clear of any encumbrances. The SF Agreement contains customary representations, warranties, covenants and closing conditions for transactions of this type.
On the terms and subject to the conditions set forth in the SF Agreement, the consideration delivered by Voice Assist to us for the SF Shares consist of the issuance at Closing to us of that number of shares of common stock of Voice Assist, par value $0.001 per share, that represented 19.99% of Voice Assist shares of common stock on a fully-diluted basis, calculated as of immediately following the closing of the SF Agreement.
We also entered into a Services Agreement with Voice Assist (the “SF Services Agreement”), pursuant to which we provide non-exclusive general advisory, support, collaboration and related services to Voice Assist from time to time.
On the terms and subject to the conditions set forth in the SF Services Agreement, the consideration to be delivered by Voice Assist to us consists of (i) deferred cash consideration in an aggregate amount of $1,000,000, payable solely from future Voice Assist equity and/or debt financing transactions completed during the five-year period beginning on the execution date of the SF Services Agreement, in installments equal to no less than 5% and no more than 15% of the gross proceeds actually received by Voice Assist in each such financing, with each installment payable within 20 days after Voice Assist’s receipt of such proceeds, subject to an aggregate cap of $1,000,000; (ii) ongoing royalty consideration equal to 75% of the gross profit generated from “New Future Projects” (as defined in the Services Agreement) during the first three years following such execution date, 15% of such gross profit generated during years four through ten following such date, and 5% thereafter, in each case calculated as set forth in the SF Services Agreement; and (iii) an amount equal to 75% of any “Ecolab Gross Proceeds” (as defined in the Services Agreement) actually received by Voice Assist, Save Foods or their respective affiliates in respect of the “Ecolab Claim,” in each case as defined and on the terms set forth in the SF Services Agreement.
The SF Services Agreement will remain in effect through calendar year 2026, and we may, in our sole discretion, extend the SF Services Agreement from time to time until we have received the full amount of the consideration payable to us under the SF Services Agreement.
Issuances to Directors
On December 23, 2024, our board of directors, upon the recommendation of our compensation committee and following the non-binding advisory approval by our stockholders at their annual meeting held on November 13, 2024, issued an aggregate of 18,574 shares of common stock under the 2022 Plan.
There were no issuances of equity securities to directors during the year ended December 31, 2025.
On February 9, 2026, we issued 116,286 shares of common stock to the chairman of the board of directors.
Results of Operations
Operating Expenses
Our current operating expenses consist of four components - research and development expenses, general and administrative expenses, change in fair value of contingent consideration and depreciation and amortization.
Research and Development Expenses, net
Our research and development expenses consist primarily of professional fees and other related research and development expenses such as field tests.
The following table sets forth the breakdown of research and development expenses:
Year Ended December 31
Salaries and related expenses
Subcontractors
Laboratory and field tests
Total
General and Administrative Expenses
General and administrative expenses consist primarily of professional services, share based compensation and other non-personnel related expenses.
The following table sets forth the breakdown of general and administrative expenses:
Year Ended December 31
Professional services
Share based compensation
Salaries and related expenses
Legal expenses
Insurance
Registration fees
Other expenses
Total
Comparison of the Year Ended December 31, 2025 to the Year Ended December 31, 2024
Results of Operations
The following table summarizes our results of operations for the years ended December 31, 2025 and 2024:
Year Ended December 31
Operating expenses:
Research and development expenses
General and administrative expenses
Change in fair value of contingent consideration
Depreciation and amortization
Operating loss
Finance expenses, net
Other income
Changes in fair value of an investment in an associate measured under the fair value option
Net loss before tax
Income taxes
Net loss from continuing operation
Net loss from discontinued operations
Net loss
Less: Net loss attributable to non-controlling interests
Net loss attributable to the Company’s stockholders
Loss per share from continuing operations (basic)
Loss per share from discontinued operations (basic)
Total loss per share (basic)
Weighted average number of shares of common stock outstanding- basic
Loss per share from continuing operations (diluted)
Loss per share from discontinued operations (diluted)
Total loss per share (diluted)
Weighted average number of shares of Common Stock outstanding -diluted
Research and Development Expenses
Research and development expenses consist of Salaries and related expenses, service providers’ costs, related materials and overhead expenses. Research and development expenses for the year ended December 31, 2025 were $179,000, compared to no research and development expenses for the year ended December 31, 2024. The increase was attributable to research and development activities following the acquisition of MitoCareX in October 2025, including personnel-related expenses and costs associated with its ongoing development programs.
General and Administrative Expenses
General and administrative expenses consist primarily of professional services, salaries and related expenses including share based compensation and other non-personnel related expenses, including legal expenses and directors and officers insurance costs. General and administrative expenses for the year ended December 31, 2025 were $5,109,000, an increase of $1,826,000, or 56%, compared to general and administrative expenses of $3,283,000 for the year ended December 31, 2024. The increase was primarily attributable to higher share-based compensation to our employees and service providers, as well as increased professional services and legal expenses, partially offset by a decrease of insurance costs.
Change in fair value of contingent consideration
Change in fair value of contingent consideration for the year ended December 31, 2025 was a gain of $1,136,000. The gain is related to the contingent cash and equity consideration recognized in connection with the acquisition of MitoCareX in October 2025. The fair value of the contingent consideration is remeasured at each reporting date, and changes in fair value are recognized in the statement of operations. The gain was primarily attributable to a decrease in the estimated fair value of the contingent consideration, mainly driven by a decline in the Company’s share price.
Depreciation and amortization
Depreciation and amortization for the year ended December 31, 2025 was $78,000, compared to $0 for the year ended December 31, 2024. The increase was attributable to the amortization of intangible assets recognized in connection with the acquisition of MitoCareX in October 2025 as part of the purchase price allocation.
Financing expenses, Net
Financing expenses, net for the year ended December 31, 2025 was $1,545,000, an increase of $1,293,000, or 513%, compared to financing expenses of $252,000 for the year ended December 31, 2024. The increase is mainly a result of an increase in financing income related to changes in the fair value of PIPE’s warrant liability and credit facility.
Income taxes
Income tax benefit for the year ended December 31, 2025 was $18,000. The tax benefit in 2025 was primarily attributable to a reduction in deferred tax liabilities, and does not reflect taxable income generated from operations. The decrease in deferred tax liabilities was primarily related to the amortization of intangible assets recognized in connection with the acquisition of MitoCareX, which resulted in a corresponding income tax benefit.
Net Loss from continued operations
Net loss from continued operations for the year ended December 31, 2025 was $3,595,000, compared to $4,319,000 for the year ended December 31, 2024, a decrease of $724,000, or 17%.
Net loss from discontinued operations
Net loss from discontinued operations for the year ended December 31, 2025 was $561,000, compared to $1,028,000 for the year ended December 31, 2024. The net loss from discontinued operations relates to the Company’s former Save Foods business, which was classified as discontinued operations during 2025.
The 2025 results include operating losses associated with this business, partially offset by a gain recognized in connection with the sale of the Company’s NTWO OFF Ltd operations in April 2025. The 2024 results include operating losses of both the Save Foods and NTWO OFF Ltd businesses.
Total Net Loss
As a result of the foregoing, our total net loss for the year ended December 31, 2025 was $4,156,000, compared to $5,347,000 for the year ended December 31, 2024, a decrease of $1,191,000, or 22%.
Critical Accounting Policies and Estimates
We describe our significant accounting policies more fully in Note 2 to our consolidated financial statements included elsewhere in this Annual Report. We believe that the accounting policy described in Note 2 is critical in order to fully understand and evaluate our financial condition and results of operations.
We prepare our financial statements in accordance with the Generally Accepted Accounting Principles in the United States of America (“GAAP”). At the time of the preparation of the financial statements, our management is required to use estimates, evaluations and assumptions which affect the application of the accounting policy and the amounts reported for assets, obligations, income and expenses. Any estimates and assumptions are continually reviewed. The changes to the accounting estimates are credited during the period in which the change to the estimate is made.
Stock-based Compensation
Employees and other service providers of our company may receive benefits by way of stock-based compensation settled with company options exercised for shares of our common stock. The cost of transactions with employees settled with capital instruments is measured based on the fair value of the capital instruments on the granting date. The fair value is determined using an accepted options pricing model. The model is based on share price, grant date and on assumptions regarding expected volatility and expected lifespan.
The cost of the transactions settled with capital instruments is recognized in profit or loss together with a corresponding increase in the equity over the period in which the performance and/or service takes place, and ending on the date on which the relevant employees are entitled to the benefits (the “Vesting Period”). The aggregate expense recognized for transactions settled with capital instruments at the end of each reporting date and until the Vesting Period reflects the degree to which the Vesting Period has expired. The expense or income in profit or loss reflects the change in the aggregate expense recognized as of the end of the reported period.
Liquidity and Capital Resources
Since our inception through December 31, 2025, we have funded our operations, principally with the issuance of equity and debt.
As of December 31, 2025, we had cash and cash equivalents of $3,832,000, as compared to $1,923,000 as of December 31, 2024. As of December 31, 2025, we had a working capital of $4,580,000, as compared to $2,560,000 as of December 31, 2024. The increase in our cash balance is mainly attributable to cash provided by financing activities. During 2025, the Company completed the sale of its NTWO OFF Ltd operations and classified its Save Foods business as held for sale and discontinued operations. Accordingly, the results of these operations are presented separately in the consolidated statements of operations, and prior period balances have been reclassified to conform to the current presentation. Cash flows related to these discontinued operations are disclosed in the notes to the consolidated financial statements. The Company does not expect discontinued operations to have a material impact on its liquidity and capital resources.
The table below presents our cash flows for the periods indicated:
Year Ended December 31
Net cash used in operating activities
Net cash used in investing activities
Net cash provided by financing activities
Effect of exchange rate changes on cash and cash equivalents
Increase (decrease) in cash and cash equivalents and restricted cash
Operating Activities
Net cash used in operating activities was $3,808,000 for the year ended December 31, 2025, as compared to $3,419,000 for the year ended December 31, 2024. Cash used in operating activities primarily reflects the Company’s net loss, adjusted for non-cash items, including share-based compensation, issuance of shares to employees and service providers, changes in the fair value of contingent consideration and other financial instruments, and gains from standby equity purchase agreements. The increase in net cash used in operating activities was also affected by changes in working capital, including changes in accounts payable and other liabilities, which include amounts related to discontinued operations.
Investing Activities
Net cash used in investing activities was $3,233,000 for the year ended December 31, 2025, as compared to net cash used in investing activities of $1,889,000 for the year ended December 31, 2024. The increase in cash used in investing activities was primarily attributable to investments in renewable energy projects, including a solar photovoltaic joint venture project, loans granted, and cash used in the acquisition of MitoCareX.
Financing Activities
Net cash provided by financing activities was $8,856,000 for the year ended December 31, 2025, as compared to $3,047,000 for the year ended December 31, 2024. The increase was primarily attributable to proceeds from standby equity purchase agreements of $4,151,000, proceeds from a PIPE agreement, proceeds from the exercise of warrants under the PIPE agreement, and proceeds from a promissory note. These increases were partially offset by repayments of credit facilities and promissory notes.
Financial Arrangements
On July 23, 2023, we entered into a purchase agreement with YA II PN, Ltd. (the “Investor”), pursuant to which the Investor agreed to purchase up to $3,500,000 of common stock, for 40 months from the date of the purchase agreement. The price of the shares to be issued under the Purchase Agreement was 94% of the lowest volume-weighted average price of the common stock for the three days prior to the delivery of each of our advance notices subject to certain limitations, including that the Investor cannot purchase a number of shares that would result in it beneficially owning more than 4.99% of our outstanding shares of common stock. We may request the Investor to advance up to $700,000 of the $3,500,000 commitment amount, with such advances to be evidenced by a promissory note. We cannot request any such advances after January 31, 2024.
On December 22, 2023, we entered into the Purchase Agreement with the Investor, pursuant to which the Investor has agreed to purchase up to $20 million of the common stock over the course of 36 months from the date of the Purchase Agreement. The price of shares to be issued under the Purchase Agreement will be 94% of the lowest VWAP of our common stock for the three trading days immediately following the delivery of each Advance notice by us. The Purchase Agreement will terminate automatically on the earlier of December 22, 2027, or when the Investor has purchased an aggregate of $20 million of our shares of common stock. We have the right to terminate the Purchase Agreement upon five trading days’ prior written notice to the Investor.
In connection with and subject to the satisfaction of certain conditions set forth in the Purchase Agreement, upon our request, the Investor pre-advanced to us up to $3,000,000 of the $20,000,000 commitment amount (a “Pre-Advance”), with each Pre-Advance to be evidenced by a promissory note (each, a “Note”). The Pre-Advance made to us will be subject to a 3% discount to the principal amount equal to each Note. Each Note accrues interest on the outstanding principal balance at the rate of 8% per annum. The Company is required to pay, on a monthly basis, one tenth of the outstanding principal amount of each Note, together with accrued and unpaid interest, either (i) in cash or (ii) by submitting an Advance notice pursuant to the Purchase Agreement and selling the Investor shares, or any combination of (i) or (ii) as determined by us. The initial repayment is due 60 days after the issuance of a Note, followed by subsequent payments due every 30 days after the previous payment. Unless otherwise agreed to by the Investor, any funds received by us pursuant to the Purchase Agreement for the sale of shares will first be used to satisfy any payments due under an outstanding Note.
On May 12, 2025, we entered into a purchase agreement with the Investor, pursuant to which the Investor committed to advance us an aggregate principal amount of up to $3,000,000 in two closings of up to $1,500,000 each, subject to the filing and effectiveness of a new registration statement registering the resale of the shares issuable under the Standby Equity Purchase Agreement dated December 22, 2023 (the “SEPA”). In connection with each closing, we will issue the Investor a promissory note in the principal amount advanced, which will bear interest at 8% per annum and mature 12 months from issuance. Beginning 60 days after issuance, we will repay each note in ten equal monthly installments of $150,000 of principal plus accrued interest, which installments may be paid, at our option, in cash or by submitting an advance notice under the SEPA, or any combination thereof. We paid the Investor a structuring fee of $15,000 and agreed to issue 675,675 shares of our common stock to the Investor as commitment shares. on July 25, 2025, we entered into an amendment to the purchase agreement with the Investor. Pursuant to the amendment, among other things, the promissory notes to be issued pursuant to the purchase agreement were revised to reflect extended payment terms and certain other modifications as agreed upon by the parties. On August 12, 2025, pursuant to the terms and conditions of the May 12, 2025 purchase agreement, as amended, the Investor advanced $1,500,000 to us and we issued a promissory note to the Investor in the principal amount of $1,500,000.
On October 1, 2024, we entered into a facility agreement with L.I.A. Pure Capital Ltd. (“Pure Capital”) for a credit facility of up to EUR 6,000,000 (the “Facility Agreement”). In connection with the Facility Agreement, we issued Pure Capital a five-year warrant to purchase up to 1,850,000 shares of our common stock at an exercise price of $1.00 per share. On December 5, 2024, Pure Capital agreed, pursuant to a waiver agreement, not to exercise the warrant until we obtain stockholder approval, and waived the requirement under the Facility Agreement to file a resale registration statement within 75 days of October 1, 2024, instead permitting such registration statement to be filed within 30 days after such stockholder approval is obtained.
On December 10, 2024, we entered into a securities purchase agreement with certain investors for gross proceeds of approximately $1,500,000 in a private placement. In the private placement, we issued an aggregate of 6,250,000 units and pre-funded units at a purchase price of $0.24 per unit (less $0.00001 per pre-funded unit), with each unit consisting of one share of common stock or a pre-funded warrant and a one and a half common warrant to purchase one share of common stock. We also entered into a registration rights agreement pursuant to which we agreed to file a resale registration statement covering the shares issued in the private placement and the shares issuable upon exercise of the warrants.
Going Concern
Since our incorporation, we incurred losses from operations and net cash outflows from operating activities as disclosed in the consolidated statements of operations and cash flows, respectively. As of December 31, 2025, we had an accumulated deficit of $38,557,000, and we expect to incur losses for the foreseeable future. We have financed our operations mainly through fundraising from various investors and have limited revenue from our products and therefore are dependent upon external sources to finance our operations. There can be no assurance that we will succeed in obtaining the necessary financing to continue our operations. These factors raise substantial doubt about our ability to continue as a going concern through at least twelve months from the report date.
We believe that our existing capital resources will be sufficient to support our operating plan through the first quarter of 2027; however, there can be no assurance of this. We will likely seek to raise additional capital to support our growth or other strategic initiatives through the issuance of debt, equity, or a combination thereof. There can be no assurance we will be successful in raising additional capital on favorable terms, or at all.
As a result, there is substantial doubt about our ability to continue as a going concern. If we are unable to obtain sufficient amounts of additional capital, we may be required to reduce the scope of our planned development, which could harm our business, financial condition and operating results. If we obtain additional funds by selling any of our equity, the percentage ownership of our stockholders will be reduced, stockholders may experience additional dilution, or the equity securities may have rights preferences or privileges senior to the common stock. If we issue debt securities, there may be negative covenants which may restrict our company’s activities. If adequate funds are not available to our company when needed on satisfactory terms, we may be required to cease operating or otherwise modify our business strategy. The financial statements included in this Annual Report do not include adjustments for measurement or presentation of assets and liabilities, which may be required should we fail to operate as a going concern.
