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Item 1A. Risk Factors

2026-03-13 compared with 2025-03-13 · 109 added, 145 removed, 252 unchanged (50% of the section changed)

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Our success is dependent on the successful commercialization of ContraPest and Evolve.

The EPA granted registration approval for ContraPest effective August 2, 2016, and as of July 12, 2018, we have received registration for ContraPest in all 50 states, the District of Columbia, and two major U.S.

territories, Puerto Rico and The U.S.

Virgin Islands.

Evolve, as a FIFRA 25(b) minimum risk pesticide, does not require federal registration with the EPA but is in the process of being registered in all 50 states, the District of Columbia, and five major U.S.

To date, we are authorized to sell Evolve in 48 states, and two major U.S.

The EPA granted registration approval for ContraPest effective August 2016, and as of July 2018, we had received registration for ContraPest in all 50 states, the District of Columbia, and two major U.S.

territories, Puerto Rico and The U.S.

Virgin Islands.

Evolve Rat and Evolve Mouse, as minimum risk pesticides under Section 25(b) of FIFRA, do not require federal registration with the EPA but are in the process of being registered in all 50 states, the District of Columbia, and two major U.S.

As of the date hereof, we are authorized to sell Evolve Rat in 48 states and territories, and Evolve Mouse in 37 states and territories.

However, we have not yet had significant sales of ContraPest and Evolve, which are our only products to date that are available for commercialization and the generation of revenue.

ContraPest, Evolve, and our other product candidates may not achieve adequate market acceptance necessary for commercial success.

Market acceptance of any of our product candidates for which we receive approval depends on a number of factors, including the following:

• the potential and perceived advantages of product candidates over alternative or complementary products;

Market acceptance of our products and any of our product candidates for which we receive approval depends on a number of factors, including the following:

• the potential and perceived advantages of our products and product candidates over alternative or complementary products;

• the effectiveness of our sales and marketing efforts and those of our collaborators;

• the efficacy and safety of such product candidates as demonstrated in trials;

• the uses, indications or limitations for which the product candidate is approved;

• the efficacy and safety of such products and product candidates as demonstrated in trials;

• the uses, indications or limitations for which the product and product candidate are approved;

• product labeling or product insert requirements of the EPA or other regulatory authorities;

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• relative convenience and ease of use;

• unfavorable publicity relating to the product.

• favorable or unfavorable publicity relating to the product.

If we cannot successfully commercialize our products, especially ContraPest and Evolve, we will not become profitable.

If any of our approved product candidates fail to achieve sufficient market acceptance, we will not be able to generate significant revenues or become profitable.

If any of our products or future approved product candidates fail to achieve sufficient market acceptance, we will not be able to generate sufficient revenues to become profitable.

The commercial success of ContraPest and Evolve will depend on a number of factors, including the following:

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• the effectiveness of our own or our potential strategic partners’ marketing, sales and distribution strategy and operations;

• convincing PMPs to deploy ContraPest and Evolve in quantity as an enhancement to, or replacement of, their current strategy of rodenticide use;

• convincing customers to deploy ContraPest and Evolve in quantity as an enhancement to, or replacement of, their current strategy of rodenticide use;

• continued refinement of our pricing strategy;

• our ability to manufacture quantities of ContraPest and Evolve using commercially acceptable processes and at a scale sufficient to meet anticipated demand and enable us to reduce our cost of manufacturing;

• a continued acceptable safety profile of ContraPest.

• a continued acceptable safety profile of Evolve and ContraPest.

Many of these factors are beyond our control.

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We may expand our operations, and as a result of many factors, some of which may be currently unknown to us, our expenses may be higher than expected.

Securing additional financing may divert our management from their day-to-day activities, which may adversely affect our ability to develop and commercialize our product candidates, including ContraPest and Evolve.

Securing additional financing may divert our management from their day-to-day activities, which may adversely affect our ability to develop and commercialize our products and product candidates, including ContraPest and Evolve.

In addition, we cannot guarantee that future financing will be available in sufficient amounts or on terms acceptable to us, if at all.

If we are unable to raise additional capital when required or on acceptable terms, we may be required to take certain actions, including the following:

• significantly delay, scale back or discontinue the development or commercialization of our product candidates, including ContraPest and Evolve;

• significantly delay, scale back or discontinue the development or commercialization of our products and product candidates, including ContraPest and Evolve;

• seek strategic partners for the manufacturing, sales and distribution of ContraPest or Evolve or any of our other product candidates at an earlier stage than otherwise would be desirable or on terms that are less favorable than might otherwise be available;

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The occurrence of any of the events described above would have a material adverse effect on our business, operating results and prospects and on our ability to develop our product candidates.

If we are unable to establish and maintain an effective sales force and marketing and distribution infrastructures, or enter into and rely upon acceptable third-party relationships, we may be unable to generate any revenue.

We continue to develop a functional infrastructure for the sales, marketing and distribution of our products;

however, the cost of establishing and maintaining such an infrastructure may exceed the cost-effectiveness of doing so.

market products, we must continue to build our sales, marketing, managerial and other non-technical capabilities or make arrangements with third parties to perform these services for which we would incur substantial costs.

In order to market products, we must continue to build our sales, marketing, managerial and other non-technical capabilities or make arrangements with third parties to perform these services for which we would incur substantial costs.

If we are unable to establish and maintain adequate sales, marketing and distribution capabilities, whether independently or with third parties, we may not be able to generate sufficient product revenue to become profitable.

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We train our marketing personnel and sales representatives to not promote our products for uses outside of the intended use, however, we cannot otherwise prevent all instances of misuse.

Further, the marketing and sales representatives that we have hired to help meet the demand for our products may not have received proper training or have the working knowledge needed to adequately advise our customers how to safely use our products.

Further, the marketing and sales

representatives that we have hired to help meet the demand for our products may not have received proper training or have the working knowledge needed to adequately advise our customers how to safely use our products.

Misuse of our products may cause an increased risk of injury to customers, which could harm our reputation in the marketplace, as well as lead to potential product liability lawsuits.

We are currently operating in a period of economic uncertainty, which has been significantly impacted by geopolitical instability, inflation, increases in interest rates, and other disruptions in credit and financial marktets.

Economic downturns may adversely affect our customers.

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Increases in interest rates may cause a reduction in spending, which could result in a decrease in revenue.

We may be impacted by geopolitical tensions and conflicts, including changes to trade policies and regulations, such as tariffs.

In addition, there can be no assurances that fuel prices, raw material costs, or other operating costs, all of which may be subject to inflationary pressures, will not materially increase in future years.

Our business may be impacted by geopolitical events, including military conflicts, threatened hostilities, conflicts or heightened tension among alliance countries and other geopolitical conflicts.

In addition, materials sourced from suppliers located outside the U.S.

have or may become subject to tariffs under U.S.

trade policies.

There can be no assurances that fuel prices, raw material costs, or other operating costs, all of which may be subject to inflationary pressures, will not materially increase in future years.

We could be required to collect additional sales, value added or similar taxes or be subject to other tax liabilities that may increase the costs our clients would have to pay for our products and adversely affect our results of operations.

We collect sales, value added or similar indirect taxes in a number of jurisdictions.

An increasing number of states have adopted laws that attempt to impose sales tax collection obligations on out-of-state companies.

Similarly, many foreign jurisdictions have considered or adopted laws that impose taxes on companies despite not having a physical presence in the foreign jurisdiction.

A successful assertion by one or more states, or foreign jurisdictions, requiring us to collect taxes where we presently do not do so, or to collect more taxes in a jurisdiction in which we currently do collect some taxes, could result in substantial tax liabilities, including taxes on past sales, as well as penalties and interest.

This could also create additional administrative burdens for us, put us at a competitive disadvantage if they do not impose similar obligations on our competitors, and decrease our future sales, which could harm our business and results of operations.

Risks Related to Regulatory Matters

Regulatory approval processes of the EPA and comparable foreign regulatory authorities are lengthy, time-consuming and unpredictable, and if we are ultimately unable to obtain regulatory approval for our product candidates, our business may fail.

The EPA review process for a product with one or more new active ingredients typically takes approximately two years to complete and approval is never guaranteed.

In addition, we continue to seek approvals to expand labels and use designations for ContraPest to broaden its market and usability.

Our efforts could fail to receive approval from the EPA, with respect to ContraPest or our product candidates, or from a comparable foreign regulatory authority for many reasons, including the following:

Regulatory approval processes of the EPA, state and comparable foreign regulatory authorities are lengthy, time-consuming and unpredictable, and if we are ultimately unable to obtain regulatory approval for our product candidates, our business may fail.

Regulatory approval for a product is never guaranteed.

In addition, we continue to seek approvals to expand labels and use designations to broaden markets and usability.

Our efforts could fail to receive approval from regulatory authorities for many reasons, including the following:

• disagreement over the design or implementation of our trials;

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• the insufficiency of data collected from trials to obtain regulatory approval;

• disagreement over whether a product is exempted from registration requirements;

• irreparable or critical compliance issues relating to our manufacturing process;

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In addition, we may be required, from time to time, to provide further testing results and certifications to the EPA and state regulatory agencies for ContraPest or Evolve.

For instance, we have found it challenging to produce applicable stability test results for one of our active ingredients, due in part to the small quantity used in the final product and continue to work with the EPA to develop appropriate biological and/or chemical measurements for active ingredient stability.

Because our data continues to demonstrate the long-term efficacy of ContraPest, we believe that the testing is a matter we will resolve.

If the EPA or comparable foreign regulatory authorities become aware of new information after approval of ContraPest, Evolve, or any other product candidate, or we are unable to adequately complete required testing and certification requirements, a number of potentially significant negative consequences could result, including the following:

If the EPA or comparable foreign regulatory authorities become aware of new information after approval of ContraPest, Evolve, or any other product candidate, or if we are unable to adequately complete required testing and certification requirements, a number of potentially significant negative consequences could result, including the following:

• we may be forced to suspend marketing of such product;

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• the EPA may require the establishment or modification of restricted use, or a comparable foreign regulatory authority may require the establishment or modification of a similar strategy that may, for instance, restrict distribution of our product and impose burdensome implementation requirements on us;

• products sold under the FIFRA minimum risk exemption could be deemed non-exempt by the EPA, potentially requiring additional compliance steps and uncertainty until such products receive further approvals;

• we may be required to change the way the product is administered or conduct additional trials;

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• our reputation may suffer.

Any of these events could prevent us from achieving or maintaining market acceptance of the particular product candidate, if approved, and could significantly harm our business, results of operations and prospects.

Any of these events could prevent us from achieving or maintaining market acceptance of the particular product or product candidate, if approved, and could significantly harm our business, results of operations and prospects.

Moreover, existing government regulations may change, and additional government regulations may be enacted that could prevent, limit or delay regulatory approval of product candidates requiring such approval.

If we are slow or unable to adapt to changes in existing requirements or the adoption of new requirements or policies, or if we are not able to maintain regulatory compliance, we may lose any marketing approval that we may have obtained and/or be subject to different marketing requirements or fines or enhanced government oversight and reporting obligations, which would adversely affect our business, prospects, and ability to achieve or sustain profitability.

Even following receipt of any regulatory approval or introduction of products or product candidates, we will continue to be subject to regulation of our manufacturing processes and advertising practices.

Even after receiving any regulatory approval or introducing products or product candidates, we will continue to be subject to regulation of our manufacturing processes and advertising practices.

As a manufacturer of pest control products, we are subject to continual government oversight and periodic inspections by the EPA and other regulatory authorities.

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In addition, the EPA strictly regulates the advertising and promotion of pest control products, and these pest control products may only be marketed or promoted for their EPA-approved uses, consistent with the product’s approved labeling.

Advertising and promotion of any product candidate that obtains approval in the U.S.

will be heavily scrutinized by the EPA, other applicable state regulatory agencies and the public.

Violations, including promotion of our products for unapproved or off-label uses, are subject to enforcement actions, inquiries and investigations, and civil, criminal and/or administrative sanctions imposed by the EPA.

Advertising and promotion of any product candidate that obtains approval in the United States will be subject to heavy scrutiny by the EPA, other applicable state regulatory agencies, and the public.

Violations, including promotion of our

products for unapproved or off-label uses, are subject to enforcement actions, inquiries and investigations, and civil, criminal and/or administrative sanctions imposed by the EPA.

Failure to obtain regulatory approval in foreign jurisdictions would prevent our products or product candidates from being marketed in those jurisdictions.

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Obtaining foreign regulatory approvals and maintaining compliance with foreign regulatory requirements could result in significant delays, difficulties, and cost for us, and could delay or prevent the introduction of our products in certain countries.

Approval by the EPA does not ensure approval by regulatory authorities in other countries or jurisdictions, but EPA approval may influence decisions by the foreign regulatory authority.

If we are unable to obtain approval of our products or product candidates by regulatory authorities in the world market, the commercial prospects of that product candidate may be significantly diminished, and our business prospects could decline.

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Our failure to attract and/or retain key personnel could impede the achievement of our research and development and commercialization objectives.

We have internal manufacturing capabilities to meet our current and near term forecasted demand for ContraPest, however, we must develop additional manufacturing capability or rely upon third parties to manufacture our products to meet future demand and our single location manufacturing operations could be disrupted.

Our existing internal manufacturing platform is adequate for meeting our current and near term forecasted demand for our products.

We may be required to spend significant time and resources to expand these manufacturing facilities to fully meet future demand.

If we are unable to develop full-scale manufacturing capabilities, we may not be able to meet demand of our products without relying on third party manufacturers, which could adversely affect our operations or financial condition.

In addition, if our manufacturing operations fail or are disrupted for any reason, including because of labor, disasters, and/or equipment malfunctions, among others, our ability to timely produce our products may be adversely affected, which would harm our sales and reputation.

We only operate in a single location, which means we do not have back-up facilities to produce our products during a time when our manufacturing facility becomes unavailable.

We will need to expand our operations and grow the size of our organization, and we may experience difficulties in managing this growth.

As of December 31, 2024, we had 23 full-time employees.

As our development and commercialization plans and strategies develop, we will need additional managerial, operational, sales, marketing, scientific and financial headcount and other

We believe that our existing internal manufacturing capabilities are sufficient to meet our current and near term forecasted demand for our products.

However, to meet future demand, we may need to expand our manufacturing capability or rely upon third-party manufacturers.

Expanding our internal facilities could require significant time and resources, and there can be no assurance that such efforts will be successful or timely.

If we are unable to develop sufficient manufacturing capacity, reliance on third-party manufacturers may be necessary, which could disrupt operations or adversely affect our business, financial condition, or results of operations.

In addition, our manufacturing operations are currently concentrated in a single location, making them vulnerable to potential disruptions.

In addition, if our manufacturing operations fail or are disrupted for any reason, including because of labor, disasters, and/or equipment malfunctions, among others, our ability to produce our products in a timely manner may be adversely affected, which would harm our sales and reputation.

We only operate in a single location, which means we do not have backup facilities to produce our products during a time when our manufacturing facility becomes unavailable.

We will need to expand our operations and grow our organization, and we may experience difficulties in managing this growth.

As of December 31, 2025, we had 23 full-time employees and one part-time employee.

As our development and commercialization plans and strategies develop and progress, we will need additional managerial, operational, sales, marketing, scientific and financial headcount and other resources.

Our management, personnel, and systems currently in place may not be adequate to support this future growth.

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Our failure to accomplish any of these tasks could prevent us from successfully growing our business.

Business or supply chain disruptions could seriously harm our future revenues and financial condition and increase our costs and expenses, particularly because we have limited suppliers and a critical ingredient for ContraPest is currently sourced from China.

Business or supply chain disruptions could seriously harm our future revenues and financial condition and increase our costs and expenses.

Our operations could be subject to a variety of potential business disruptions, including power shortages, telecommunications failures, water shortages, floods, fires, earthquakes, extreme weather conditions, medical epidemics and other natural or man-made disasters or other interruptions, for which we are predominantly self-insured.

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Moreover, we rely on third parties to supply various ingredients and other items which are critical for producing our product candidates.

We currently use one supplier for each of our two active ingredients, triptolide and VCD.

Our ability to produce our product candidates would be disrupted if the operations of these suppliers are affected by a man made or natural disaster or other business interruption.

Because triptolide is sourced from China and other Asian countries, we have a greater risk of supply interruption, including as a result of tariff and trade disputes, or disruptive events like the outbreak of the Coronavirus, also known as COVID-19.

The ultimate impact on our operations from any business interruption impacting us or any of our significant suppliers is unknown, but our operations and financial condition would likely suffer adverse consequences.

Further, any significant uninsured liability may require us to pay substantial amounts, which would adversely affect our business, results of operations, financial condition and cash flows from future prospects.

We are dependent on triptolide, a key ingredient for ContraPest, which has limited sources and must be in a very refined condition.

If we are unable to develop additional sources of or alternatives to triptolide, a key ingredient for ContraPest, our long-term ability to produce ContraPest at a cost-effective price could be in jeopardy.

If market demand for triptolide causes the price to increase beyond our ability to market at a competitive price or causes the quality of the refined ingredient to be less than needed for our production, our ability to commercialize ContraPest could be limited or delayed, which would adversely affect our business, results of operations and financial condition.

A variety of risks associated with marketing our product candidates internationally could materially adversely affect our business.

We may seek regulatory approval of our product candidates outside of the United States and, in that case, we expect that we will be subject to additional risks related to operating in foreign countries if we obtain the necessary approvals, including the following:

A variety of risks associated with marketing our products and product candidates internationally could materially adversely affect our business.

We have begun to market Evolve products internationally through distributors and we may seek regulatory approval of our product candidates outside of the United States.

We expect that we will be subject to additional risks related to operating in foreign countries with respect to Evolve and any other approved products, including the following:

• differing regulatory requirements in foreign countries;

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• compliance with tax, employment, immigration and labor laws for employees living or traveling internationally;

• foreign taxes, including withholding of payroll taxes;

• foreign currency fluctuations, which could result in increased operating expenses and reduced revenue, and other obligations incident to doing business in another country;

• difficulties staffing and managing foreign operations;

• workforce uncertainty in countries where labor unrest is more common than in the United States;

• potential liability under the U.S.

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The rights already granted under any of our currently issued patents and those that may be granted under future issued patents may not provide us with the proprietary protection or competitive advantages we are seeking.

If we are unable to obtain and maintain protection for our technology and products, or if the scope of the protection obtained is not sufficient, our competitors could develop and commercialize technology and products similar or superior to ours, and our ability to successfully commercialize our technology and products may be adversely affected.

With respect to patent rights, we do not know whether any of our pending patent applications for any of our technologies or products will result in the issuance of patents that protect such technologies or products, or if our licensed patent will effectively prevent others from commercializing competitive technologies and products.

If we are unable to obtain and maintain protection for our technology and products, or if the scope of the protection obtained is not sufficient, our

competitors could develop and commercialize technology and products similar or superior to ours, and our ability to successfully commercialize our technology and products may be adversely affected.

Our pending patent applications cannot be enforced against third parties practicing the technology claimed in such applications unless and until a patent issues from such applications.

Further, the examination process may require us to narrow the claims for our pending patent applications, which may limit the scope of patent protection that may be obtained if these applications issue.

Because the issuance of a patent is not conclusive as to its inventorship, scope, validity or enforceability, issued patents that we own or have licensed from third parties may be challenged in the courts or patent offices in the U.S.

and internationally.

Because the issuance of a patent is not conclusive as to its inventorship, scope, validity, or enforceability, issued patents that we own may be challenged in the courts or patent offices in the United States and internationally.

Such challenges may result in the loss of patent protection, the narrowing of claims in such patents, or the invalidity or unenforceability of such patents, which could limit our ability to stop others from using or commercializing similar or identical technology and products or limit the duration of the patent protection for our technology and products.

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• others may independently develop similar or alternative technologies or duplicate any of our technologies without infringing on our intellectual property rights;

• issued patents that we own or have exclusively licensed may not provide us with any competitive advantages, or may be held invalid or unenforceable, as a result of legal challenges by our competitors;

• our competitors might conduct research and development activities in the U.S.

and other countries that provide a safe harbor from patent infringement claims for certain research and development activities, as well as in countries where we do not have patent rights and then use the information learned from such activities to develop competitive products for sale in our major commercial markets;

• issued patents that we own may not provide us with any competitive advantages, or may be held invalid or unenforceable, as a result of legal challenges by our competitors;

• our competitors might conduct research and development activities in the United States and other countries that provide a safe harbor from patent infringement claims for certain research and development activities, as well as in countries where we do not have patent rights and then use the information learned from such activities to develop competitive products for sale in our major commercial markets;

• we may not develop additional proprietary technologies that are patentable or otherwise protectable;

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We cannot assure you that licenses will be available on acceptable terms, if at all.

Furthermore, because of the potential for significant damage awards, which are not necessarily predictable, it is not unusual to find even arguably unmeritorious claims resulting in large settlements.

Furthermore, because of the potential for significant damage awards, that are not necessarily predictable, it is not unusual to find even arguably unmeritorious claims resulting in large settlements.

If any infringement or other intellectual property claim made against us by any third party is successful, or if we fail to develop non-infringing technology or license the proprietary rights on commercially reasonable terms and conditions, our business, operating results, and financial condition could be materially adversely affected.

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A third party may hold intellectual property, including patent rights that are important or necessary to the development of our product candidates.

It may be necessary for us to use the patented or proprietary technology of a third party to

manufacture or otherwise commercialize our own technology or products, in which case we would be required to obtain a license from such third party.

It may be necessary for us to use the patented or proprietary technology of a third party to manufacture or otherwise commercialize our own technology or products, in which case we would be required to obtain a license from such third party.

Licensing such intellectual property may not be available or may not be available on commercially reasonable terms, which could have a material adverse effect on our business and financial condition.

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In addition, regardless of merit or outcome, claims brought against us that are uninsured or under insured could result in unanticipated costs, which could harm our business, financial condition and operating results and reduce the trading price of our stock.

For example, we have become aware that we were involved in a transaction in which an investor of the Company may have resold approximately 17,500 shares of our common stock pursuant to a registration statement that had not yet been declared effective by the SEC.

As a result, it is possible that the SEC could bring an action against us, or we may ultimately be responsible for an action for rescission by purchasers of the securities that were resold.

If the SEC were to bring such an enforcement action against us, or if purchasers were to bring such an action for rescission, it may have a material adverse effect on our financial position.

Product liability lawsuits against us could cause us to incur substantial liabilities and to limit commercialization of any products that we may develop.

Product liability lawsuits against us could cause us to incur substantial liabilities and limit commercialization of any products that we may develop.

We face an inherent risk of product liability exposure related to the use of ContraPest and Evolve.

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• diversion of management and scientific resources from our business operations;

• the inability to commercialize our product candidates.

• the inability to commercialize our products.

We may be unable to obtain commercially reasonable product liability insurance for any products approved for marketing.

Large judgments have been awarded in class action lawsuits based on products that had unanticipated side effects, including, without limitation, any potential adverse effects of our products on humans or other species.

Large judgments have been awarded in class action lawsuits arising from products that had unanticipated side effects, including, without limitation, any potential adverse effects of our products on humans or other species.

A successful product liability claim or series of claims brought against us, particularly if judgments exceed our insurance coverage, could decrease our cash and adversely affect our business.

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We have not fully assessed our internal control over financial reporting.

If we experience material weaknesses in the future or otherwise fail to maintain an effective system of internal controls, we may not be able to accurately or timely

report our financial condition or results of operations, which may adversely affect investor confidence in us and, as a result, the value of our common stock.

If we experience material weaknesses in the future or otherwise fail to maintain an effective system of internal controls, we may not be able to accurately or timely report our financial condition or results of operations, which may adversely affect investor confidence in us and, as a result, the value of our common stock.

A material weakness is a deficiency, or combination of deficiencies, in internal control over financial reporting such that there is a reasonable possibility that a material misstatement of our financial statements will not be prevented or detected on a timely basis.

Our Annual Report on Form 10-K for the year ended December 31, 2024 does not include an attestation report of our registered public accounting firm due to a transition period established by rules of the SEC for smaller reporting companies.

As a result, we have not yet fully assessed our internal control over financial reporting and are unable to assure that the measures we have taken to date, together with any measures we may take in the future, will be sufficient to remediate the control deficiencies that led to our material weaknesses in our internal control over financial reporting, or to avoid potential future material weaknesses.

Our Annual Report on Form 10-K for the year ended December 31, 2025, does not include an attestation report of our registered public accounting firm due to our status as a non-accelerated filer.

As a result, we have not yet fully assessed our internal control over financial reporting and are unable to assure that the measures we have taken to date, together with any measures we may take in the future, will be sufficient to remediate the control deficiencies that may have led to any material weaknesses in our internal control over financial reporting, or to avoid potential future material weaknesses.

If we are unable to develop and maintain an effective system of internal control over financial reporting, successfully remediate any existing or future material weaknesses in our internal control over financial reporting, or identify any additional material weaknesses, the accuracy and timing of our financial reporting may be adversely affected, we may be unable to maintain compliance with securities law requirements regarding timely filing of periodic reports and Nasdaq listing requirements, investors may lose confidence in our financial reporting, and our stock price may decline as a result.

Privacy breaches and other cyber security risks related to our business and vulnerabilities through the use of evolving tools such as Artificial Intelligence could negatively affect our reputation, credibility and business.

We are making sales through our new e-Commerce tool, which depends on information technology systems and networks.

We are also responsible for storing data relating to our customers and employees and rely on third party vendors for the storage, processing and transmission of personal and Company information.

The legal and regulatory landscape surrounding Artificial Intelligence technologies is rapidly evolving and uncertain, including in the areas of consumer protection, intellectual property, cybersecurity, and privacy and data protection.

Consumers, lawmakers and consumer advocates alike are increasingly concerned over the security of personal information transmitted over the Internet, consumer identity theft and privacy.

We do not control our third-party service providers and cannot guarantee that they have implemented reasonable security measures to protect our employees’ and customers’ identity and privacy, or that no electronic or physical computer break-ins or security breaches will occur in the future.

Our systems and technology are vulnerable from time-to-time to damage, disruption or interruption from, among other things, physical damage, natural disasters, inadequate system capacity, system issues, security breaches, “hackers,” email blocking lists, computer viruses, power outages and other failures or disruptions outside of our control.

A significant breach of customer, employee or Company data could damage our reputation and our relationship with customers, and could result in lost sales, sizable fines, significant breach-notification costs and lawsuits, as well as adversely affect our results of operations.

Privacy breaches and other cybersecurity risks related to our business and vulnerabilities through the use of evolving tools such as Artificial Intelligence could negatively affect our reputation, credibility, and business.

We are making sales through e-Commerce tools, that depend on information technology systems and networks.

We are also responsible for storing, processing, transmitting, and protecting data relating to our business, customers, and employees, including personal and other confidential or sensitive information.

We also rely on third-party vendors for the storage, processing, and transmission of personal and confidential information.

The legal and regulatory landscape is rapidly evolving and uncertain in the areas of consumer protection, intellectual property, Artificial Intelligence, cybersecurity, and privacy and data protection.

Our data processing activities subject us to numerous data privacy and security obligations, such as various laws, regulations, guidance, industry standards, external and internal privacy and security policies, contractual requirements, and other obligations relating to data privacy and security.

In the United States, federal, state, and local governments have enacted numerous data privacy and security laws, including data breach notification laws, personal data privacy laws, consumer protection laws (e.g.

Section 5 of the Federal Trade Commission Act), comprehensive consumer data privacy laws (e.g., the California Consumer Privacy Act) and other similar laws.

Outside the United States, an increasing number of laws, regulations, and industry standards govern data privacy and security.

For example, the European Union’s General Data Protection Regulation (“EU GDPR”), the United Kingdom’s GDPR (“UK GDPR”) (collectively, “GDPR”).

Under the GDPR, companies may face temporary or definitive bans on data processing, other corrective actions, significant fines, or private litigation.

Consumers, lawmakers and consumer advocates alike are increasingly concerned over the security of data transmitted over the Internet.

Cyber-attacks, malicious internet-based activity, online and offline fraud, and other similar activities threaten the confidentiality, integrity, and availability of our sensitive information and information technology systems, and those of the third parties with whom we work.

Such threats are prevalent and continue to rise, are increasingly difficult to detect, and come from a variety of sources.

It may be difficult and/or costly to detect, investigate, mitigate, contain, and remediate a security incident.

Our efforts to do so may not be successful.

We do not control our third-party service providers and cannot guarantee that they have implemented reasonable security measures to protect our employees’ and customers’ data, identity and privacy, or that no security incidents will occur in the future.

A breach of customer, employee or confidential data could damage our reputation and our relationship with customers, and could result in lost sales, sizable fines or penalties, significant breach-notification costs, investigations, and lawsuits, as well as adversely affect our results of operations.

We may also incur additional costs in the future related to the implementation of additional security measures to protect against new or enhanced data security and privacy threats, or to comply with state, federal and international laws that may be enacted to address those threats.

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Investment in product development is highly speculative because it entails substantial upfront capital expenditures and significant risk that any potential product candidate will fail to become commercially viable or gain regulatory approval.

To date, we have financed our operations primarily through the sale of equity securities and debt financings as well as research grants.

To date, we have financed our operations primarily through the sale of equity securities, including warrants exercises, and product sales.

We have not generated sufficient revenue from product sales to date to achieve profitability.

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For the years ended December 31, 2025 and 2024, we reported net losses of $6.4 million and $6.2 million, respectively.

Thru December 31, 2024, we have accumulated deficits of $136.1 million since inception.

Since inception, we have dedicated a majority of our resources to the discovery and development and marketing of our proprietary product candidates.

We expect to continue to incur significant expenses and operating losses for the foreseeable

As of December 31, 2025, we had an accumulated deficit of $142.5 million.

Since inception, we have dedicated a majority of our resources to the discovery, development, and marketing of our proprietary products and product candidates.

We expect to continue to incur significant expenses and operating losses in the near term.

The size of our losses will depend, in part, on the rate of future expenditures and our ability to generate revenues.

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Our prior losses and expected future losses have had, and will continue to have, an adverse effect on our financial condition.

If our products or product candidates do not gain or maintain sufficient regulatory approval, or if approved, fails to achieve market acceptance, we may never become profitable.

If our products or product candidates do not gain or maintain sufficient regulatory approval, or if approved, fail to achieve market acceptance, we may never become profitable.

Even if we achieve profitability in the future, we may not be able to sustain profitability in subsequent periods.

Our failure to become and remain profitable would decrease the value of our company and could impair our ability to raise capital, expand our business, diversify our product offerings or continue our operations.

A decline in the value of our company could cause you to lose all or part of your investment.

If we are unable to continue as a going concern, our securities will have little or no value.

We have incurred operating losses since our inception, and we expect to continue to incur significant expenses and operating losses for the foreseeable future.

Our financial statements as of December 31, 2024 and 2023 have been prepared under the assumption that we will continue as a going concern.

Our independent registered public accounting firm included in its opinion for the years ended December 31, 2024, and 2023 an explanatory paragraph referring to our net loss from operations and net capital deficiency and expressing substantial doubt in our ability to continue as a going concern without additional capital becoming available.

If we encounter continued issues or delays in the commercialization of our products or greater than anticipated expenses, our prior losses and expected future losses could have an adverse effect on our financial condition and negatively impact our ability to fund continued operations, obtain additional financing in the future and continue as a going concern.

There are no assurances that such financing, if necessary, will be available to us at all or will be available in sufficient amounts or on reasonable terms.

Our financial statements do not include any adjustments that may result from the outcome of this uncertainty.

If we are unable to generate additional funds in the future through financings, sales of our products, licensing fees, royalty payments or from other sources or transactions, we will exhaust our resources and will be unable to continue operations.

If we cannot continue as a going concern, our stockholders would likely lose most or all of their investment in us.

We may not be able to comply with all applicable listing requirements or standards of The Nasdaq, and Nasdaq could delist our common stock.

A decline in the company’s value could cause you to lose all or part of your investment.

We may not be able to comply with all applicable listing requirements or standards of Nasdaq, and Nasdaq could delist our common stock.

Our common stock is listed on Nasdaq.

In order to maintain that listing, we must satisfy minimum financial and other continued listing requirements and standards.

Previously, on September 26, 2018, March 20, 2019, February 20, 2020, March 2, 2022, and, most recently, on August 25, 2023, we received a letter from the listing qualifications staff of Nasdaq (the “Staff”) providing notification that the bid price for our common stock had closed below $1.00 per share for the previous 30 consecutive business days and our common stock no longer met the minimum bid price requirement for continued listing under Nasdaq Listing Rule 5550(a)(2).

In each case, in accordance with Nasdaq Listing Rule 5810(c)(3) (A), we had an initial period of 180 calendar days to regain compliance.

On February 26, 2024, we received notice from Nasdaq that while we had not yet gained compliance with the Nasdaq Listing Rule 5550(a), the Staff had determined that we were eligible for an additional 180 calendar day period, or until August 19, 2024, to regain compliance.

To regain compliance, the closing bid price of our common stock had to be $1.00

per share or more for a minimum of 10 consecutive business days at any time before the expiration of the second compliance period.

On July 11, 2024, our stockholders approved a reverse stock split of our common stock, par value $0.001 per share, at a ratio of not less than 1-for-2 and not more than 1-for-20, with the actual ratio to be determined by our board of directors.

On July 11, 2024, our board of directors approved a final split ratio of 1-for-10 (the “July 2024 Reverse Split”).

Following such approval, on July 23, 2024, we filed with the Secretary of State of the State of Delaware an amendment to the Certificate of Incorporation to effect the reverse stock split, with an effective time of 4:01 p.m., Eastern Time on July 24, 2024.

Even if a stock split has a positive effect on the market price for the common stock immediately following a reverse stock split, performance of our business and financial results, general economic conditions and the market perception of our business, and other adverse factors which may not be in our control, could lead to a decrease in the price of our common stock following the reverse stock split.

The bid price of our common stock has been at or above $1.00 per share for a minimum of 10 consecutive business days since the July 2024 Reverse Split, resulting in regaining compliance with the minimum bid price requirement.

In the event that we again become non-compliant with any of the minimum financial and other continued listing requirements of the Nasdaq and cannot re-establish compliance within the require timeframe, our common stock could be delisted from the Nasdaq, which could have a material adverse effect on our financial condition and which would cause the value of our common stock to decline.

To maintain that listing, we must satisfy the minimum financial and other continued listing requirements and standards.

In the event that we become non-compliant with any of the minimum financial and other continued listing requirements of Nasdaq and cannot re-establish compliance within the required timeframe, our common stock could be delisted from Nasdaq, which could have a material adverse effect on our financial condition and which would cause the value of our common stock to decline.

If our common stock is not eligible for listing or quotation on another market or exchange, trading of our common stock could be conducted in the over-the-counter market or on an electronic bulletin board established for unlisted securities, such as the Pink Sheets or the OTC Bulletin Board.

In such event, it would become more difficult to dispose of, or obtain accurate price quotations for, our common stock, and there would likely be a reduction in our coverage by security analysts and the news media, which could cause the price of our common stock to decline further.

In such an event, it would become more difficult to dispose of, or obtain accurate price quotations for, our common stock, and there would likely be a reduction in our coverage by security analysts and the news media, which could cause the price of our common stock to decline further.

In addition, it may be difficult for us to raise additional capital if we are not listed on a national securities exchange.

Our reverse stock splits may decrease the liquidity of the shares of our common stock.

On July 23, 2024, the Reverse Split Committee of our board of directors approved a final split ratio of 1-for-10 to regain compliance with the Nasdaq minimum bid price requirement.

Prior to the July 2024 reverse stock split, we effected a reverse stock split in November 2023 with a ratio of 1-for-12 and in November 2022 with a ratio of 1-for-20.

The liquidity of the shares of our common stock may be affected adversely by the reverse stock splits given the reduced number of shares that are outstanding following the reverse stock splits.

In addition, the reverse stock splits increase the number of stockholders who own odd lots (less than 100 shares) of our common stock, creating the potential for such stockholders to experience an increase in the cost of selling their shares and greater difficulty effecting such sales.

Raising additional capital may cause dilution to our existing stockholders, restrict our operations or require us to relinquish rights to our technologies or product candidates.

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We may also seek to raise capital through third-party collaborations, strategic alliances, and similar arrangements.

We currently do not have any committed external source of funds.

We currently do not have any committed external funding.

Raising funds in the future may present additional challenges, and future financing may not be available in sufficient amounts or on terms acceptable to us, if at all.

The terms of any financing arrangements we enter into may adversely affect the holdings or the rights of our stockholders, and the issuance of additional securities by us, or the possibility of such issuance, may cause the market price of our shares to decline.

For example, during 2022 and 2020, we completed equity financings that resulted in the issuance of shares of common stock and warrants to purchase common stock, resulting in substantial dilution to the existing stockholders.

Similarly, in the first quarter of 2021, we again issued shares of common stock and warrants to purchase common stock, resulting in additional substantial dilution to the existing stockholders.

We generally have raised capital as the opportunity arises.

Certain of our agreements with investors and our outstanding warrants contain provisions that impose limitations on our ability to participate in certain variable rate transactions, which may limit our opportunities to obtain financing in sufficient amounts or on acceptable terms.

The sale of additional equity or convertible debt securities would dilute all of our

stockholders, and if such sales occur at a deemed issuance price that is lower than the current exercise price of our outstanding warrants sold to investors in November 2017, the exercise price for those warrants would adjust downward to the deemed issuance price pursuant to price adjustment protection contained within those warrants.

The sale of additional equity or convertible debt securities would dilute all of our stockholders.

Our various warrants contain other terms that may affect our fundraising.

In connection with any future equity offering, we may agree to amend the terms of certain of our outstanding warrants held by certain significant purchasers in this offering.

In connection with any future equity offering, we may agree to amend the terms of certain of our outstanding warrants.

Any such amendments may, among other things, decrease the exercise prices or increase the term of exercise of those warrants.

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If we are unable to expand our operations or otherwise capitalize on our business opportunities, our business, financial condition, and results of operations could be materially adversely affected.

If we are unable to raise additional funds through equity or debt financings when needed, we may be required to delay, limit, reduce or terminate our product development or commercialization efforts, or grant others rights to develop and market product candidates that we would otherwise prefer to develop and market ourselves.

Our share price is volatile, which could subject us to securities class action litigation and your investment in our securities could decline in value.

If we are unable to raise additional funds when needed, we may be required to delay, limit, reduce, or terminate our product development or commercialization efforts, or grant others rights to develop and market product candidates that we would otherwise prefer to develop and market ourselves.

Our stock price is volatile, which could subject us to securities class action litigation, and your investment in our securities could decline in value.

Our stock could be subject to wide fluctuation in response to many risk factors listed in this section, and others beyond our control, including the following:

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• issuance of new or updated research or reports by securities analysts;

• announcement or expectation of additional financing efforts, particularly if our cash available for operations significantly decreases or if the financing efforts result in a price adjustment to certain outstanding warrants;

• announcement or expectation of additional financing efforts, particularly if our cash available for operations significantly decreases;

• fluctuations in the valuation of companies perceived by investors to be comparable to us;

• share price and volume fluctuations attributable to inconsistent trading volume levels of our shares;

• stock price and volume fluctuations attributable to inconsistent trading volume levels of our shares;

• disputes or other developments related to proprietary rights, including patents, litigation matters and our ability to obtain patent protection for our technologies;

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You may not realize any return on your investment in us and may lose some or all of your investment.

Future sales, or the possibility of future sales, of a substantial number of our common shares could adversely affect the price of the shares and dilute stockholders.

Future sales of a substantial number of shares of our common stock, or the perception that such sales will occur, could cause a decline in the market price of our common stock.

This is particularly true if we sell our stock at a discount.

Any future issuance of common stock or securities convertible or exercisable into our common stock could cause a further downward adjustment of the exercise price of these warrants to the deemed issuance price if the issuance price is less than the exercise price of the warrants at the time of the new issuance.

Also, in the future, we may issue additional shares of our common stock or other equity or debt securities convertible into common stock in connection with a financing, acquisition, litigation settlement, employee arrangements, or otherwise.

Any such issuance could result in substantial dilution to our existing stockholders and could cause our common share price to decline.

An active market in the shares may not continue to develop in which investors can resell our common stock.

An active market for our shares of common stock may not continue to develop.

We cannot predict the extent to which an active market for our common stock will continue to develop or be sustained, or how the development of such a market might affect the market price for our common stock.

Market conditions in effect at the time you acquire our stock may not be indicative of the price at which our common stock will trade in the future.

Market conditions in effect at the time you acquire shares of our common stock may not be indicative of the price at which our common stock will trade in the future.

Investors may not be able to sell their common stock at or above the price they acquired it.

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We cannot assure that analysts will cover us or provide favorable coverage.

If one or more of the analysts who cover us downgrade our stock or change their opinion of our stock, our share price could decline.

If one or more of the analysts who cover us downgrade our stock or change their opinion of our stock, our stock price could decline.

If one or more of these analysts cease coverage of us or fail to regularly publish reports on us, we could lose visibility in the financial markets, which could cause our stock price or trading volume to decline.

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Having a staggered board will make it more difficult for a third party to obtain control of our board of directors through a proxy contest, which may be a necessary step in an acquisition of us that is not favored by our board of directors.

Additionally, most of our warrants provide a Black Scholes value-based payment to the warrant holders in connection with certain transactions that may discourage, delay or prevent a merger or acquisition.

We are also subject to the anti-takeover provisions of Section 203 of the Delaware General Corporation Law.

We are also subject to the anti-takeover provisions of Section 203 of the General Corporation Law of the State of Delaware (“Section 203”).

Under these provisions, if anyone becomes an “interested stockholder,” we may not enter into a “business combination” with that person for three years without special approval, which could discourage a third party from making a takeover offer and could delay or prevent a change of control.

For purposes of Section 203, “interested stockholder” means, generally,

someone owning 15% or more of our outstanding voting stock or an affiliate of ours that owned 15% or more of our outstanding voting stock during the past three years, subject to certain exceptions as described in Section 203.

For purposes of Section 203, “interested stockholder” means, generally, someone owning 15% or more of our outstanding voting stock or an affiliate of ours that owned 15% or more of our outstanding voting stock during the past three years, subject to certain exceptions as described in Section 203.

Compared sentence by sentence after normalising whitespace, quotation marks, case and digits, so re-formatting and restated figures do not read as changed language. Wording changes appear as one removal and one addition. The current filing and the prior one are authoritative.

What changed 10-K

Item 1A. Risk Factors