NMAD 10-K & 10-Q changes, risk factors and insider trading

OurThere independent registered public accounting firm has expressedis substantial doubt about our ability to continue as a going concern.

Risks Related to the Development and Regulatory Approval of Our Product Candidates Clinical-stage biopharmaceutical companies with product candidates in clinical development face a wide range of challenging activities which might entail substantial risk.

Effective September 26, 2023, BasBastiaan van der Baan, who had served as a director of the Company since June 17, 2022, replaced the Company’sour founder, Dr.John S. John S. Kovach, as President and Chief Executive Officer. Dr. Kovach passed away on October 5, 2023. Effective October 6, 2023, Mr. van der Baan Baan was appointed as Chairman of the Board of Directors. Dr. Kovach was also the Company’s Chief Scientific Officer.

Although our success depended, in part, on the continued availability and contributions of Dr. Kovach, we were able to replace Dr. Kovach on a timely basis with a qualified replacement in Mr. van der Baan.Baan and subsequently Mr. Pursglove. Furthermore, recruiting and retaining qualified scientific personnel to perform future research and development work is critical to our success. Our inability to attract or retain qualified personnel or advisors in the future could significantly weaken our management, harm our ability to compete effectively, and harm our business. The competition for qualified personnel in the pharmaceutical field is intense and, as a result, we might be unable to attract and retain qualified personnel necessary for the development of our business.

Additionally, we replaced our previous Chief Medical Officer, Dr. James S. Miser, with Dr. Jan Schellens during 2024, and we have reallocated the responsibilities responsibilities of Eric J. Forman, our Vice President and Chief Operating Officer, who resigned on December 31, 2024. Effective as of July 31, 2025, the Company agreed to accept the resignation of Dr. Schellens and to terminate his consulting agreement to allow Dr. Schellens to pursue employment opportunities. We believe that Mr. Van der Baan and Dr. Schellens areis capable of managing the Company’s research and clinical activities.

Dr.We Miser is experienced in the design and conduct of early stage clinical trials. However, we expect to rely on collaborative partners and CROs for their performance and management of clinical trials of our product candidates.

Our employees, consultants, collaborators or contractors have been previously employed at universities or third partythird-party pharmaceutical companies, including our actual or possible competitors, and received confidential and proprietary information from them. Although we try to ensure that our employees, consultants, collaborators or contractors do not use the proprietary information or know-how of others in their work for us, we may be subject to claims that these employees, consultants, collaborators or contractors, or we, have used or disclosed intellectual property, including trade secrets or other proprietary information, of any former employer. We might also be subject to claims that former employers or other third parties have an ownership interest in our patents. Litigation may be necessary to defend against these claims. We might not be successful in defending these claims, and if we fail in defending any such claims, in addition to paying monetary damages, we could lose valuable intellectual property rights, such as exclusive ownership of, or right to use, valuable intellectual property. Even if we are successful, litigation could result in substantial cost and reputational loss and be a distraction to our business.

In addition, while it is our policy to require our employees, consultants, collaborators and contractors who may be involved in the development of intellectual property to execute agreements assigning such intellectual property to us, we might be unsuccessful in executing such an agreement with each party who in fact develops intellectual property that we regard as our own. Such assignment agreements might not be self-executing or may be breached, and we might be forced to bring claims against third parties,parties or defend claims that third parties might bring against us, to determine the ownership of what we regard as our intellectual property.

Our patents and patent applications are owned solely by our wholly-ownedwholly owned subsidiary, Lixte Biotechnology, Inc., except in several instances where they are jointly owned with one of our collaborators.

The patent position of pharmaceutical companies generally is highly uncertain, involves complex legal and factual questions and has in recent years been the subject of much litigation. In addition, the laws of foreign countries might not protect our rights to the same extent as the laws of the United States. Publications of discoveries in the scientific literature often lag behind the actual discoveries, and patent applications in the United States and other jurisdictions are typically not published until after filing, or in some cases not at all. Therefore, we cannot know with certainty whether we were the first to make the inventions claimed in our solely owned or jointly owned patents or pending patent applications, or that we were the first inventors to file for patent protection of such inventions. As a result, the issuance, scope, validity, enforceability and commercial value of our patent rights are highly uncertain. Our pending and future patent applications might not result in patents being issued that protect our technology or products, in whole or in part, or that effectively prevent others from commercializing competitive technologies and products. Changes in the patent laws or their interpretation by courts or patent offices might diminish the value of our patents or patent applications,applications or narrow their scope.

We have entered into, and might in the future enter into, one or more intellectual property license agreements that are important to our business. These license agreements might impose various diligence, milestone payment, royalty and other obligations on us. For example, we might be required to use commercially reasonable efforts to engage in various development and commercialization activities with respect to licensed products,products and might need to satisfy specified milestone and royalty payment obligations. If we fail to comply with any obligations under our agreements with any of these licensors, we might be subject to termination of the license agreement in whole or in part, increased financial obligations to our licensors or loss of exclusivity in a particular field or territory, in which case our ability to develop or commercialize products covered by the license agreement will be impaired.

We might infringe the intellectual property rights of others, which may prevent or delay our product development efforts and stop us from commercializing or increaseincreasing the costs of commercializing our product candidates.

We cannot guarantee that we have identified all third partythird-party patents or pending patent applications that are or might be necessary for the commercialization of our intended products and technologies in any jurisdiction. Patent applications in the United States and elsewhere are not published until approximately 18 months after the earliest filing for which priority is claimed, with such earliest filing date being commonly referred to as the priority date. Therefore, patent applications covering our technologies and intended products could have been filed by others without our knowledge.

Additionally, pending patent applications that have been published can, subject to certain limitations, be later amended in a manner that could cover our technologies or intended products. The scope of a patent claim is determined by the interpretation of the law, the words of a patent claim, the written disclosure in a patent and the patent’s prosecution history. Our interpretation of the relevance or the scope of a patent or a pending patent application may be incorrect, which may negatively impact our ability to market our intended products. We might incorrectly determine that our technologies or intended products are not covered by a third partythird-party patent or might incorrectly predict whether a third party’s pending patent application will issue with claims of relevant scope. Our determination of the expiration date of any patent in the United States or abroad that we consider relevant might be incorrect, and we might incorrectly conclude that a third partythird-party patent does not cover our technology or intended products, is invalid or is unenforceable. Our inability to identify or correctly interpret relevant patents might negatively impact our ability to develop or market our technologies or intended products. If we fail to identify or correctly interpret relevant patents, we might be subject to infringement claims. We cannot guarantee that we will be able to successfully settle or otherwise resolve such infringement claims. If we fail in any such dispute, in addition to being liable for damages, we might be temporarily or permanently enjoined or otherwise prohibited from commercializing any of technologies or intended products that are held to be infringing. We might, if possible, also be forced to redesign intended products or product formulations so that we no longer infringe the third partythird-party intellectual property rights. Any of these events, even if we were ultimately to prevail, could require us to divert substantial financial and management resources that we would otherwise be able to devote to our business.

Filing, prosecuting and defending patents covering our product candidates in all countries throughout the world would be prohibitively expensive, and our intellectual property rights in some jurisdictions outside the United States can be less extensive than those in the United States. And filing, prosecuting and defending patents even in only those jurisdictions in which we develop or commercialize our product candidates might be prohibitively expensive or impractical. Competitors might use our technologies in jurisdictions where we have not obtained patent protection to develop their own products or technologies and, further, may export otherwise infringing products or technologies to territories where we and have patent protection, but where enforcement is not as strong as that in the United States. These third partythird-party products or technologies might compete with our product candidates, and our intellectual property rights may not be effective or sufficient to prevent third parties from competing.

If we are not able to protect and control our unpatented trade secrets, know-how and other technological innovation,innovations, we might suffer competitive harm.

We might incur substantial costs prosecuting our patent applications, maintaining our patents and patent applications, enforcing our patents, defending against third party patent infringement suits, seeking invalidation of third partythird-party patents or in-licensing third party intellectual property, as a result of litigation or other proceedings relating to patent and other intellectual property rights.

We might not have rights under some patents or patent applications that cover technologies that we use in our research, drug targets that we select, product candidates and particular uses thereof that we seek to develop and commercialize, as well as synthesis of our product candidates. Third parties might own or control these patents and patent applications in the United States and elsewhere. These third parties could bring claims against us or our collaborators that would cause us to incur substantial expenses and, if successful against us, could cause us to pay substantial damages. Further, if a patent infringement suit were brought against us or our collaborators, we or they could be forced to stop or delay research, development, manufacturing or sales of the product or product candidate that is the subject of the suit. We or our collaborators therefore might choose to seek, or be required to seek, a license from the third party and would most likely be required to pay license fees or royalties or both. These licenses might not be available on acceptable terms, or at all. Even if we or our collaborators were able to obtain a license, the rights might be nonexclusive, which would give our competitors access to the same intellectual property. Ultimately, we could be prevented from commercializing a product or product candidate,candidate or forced to cease some aspect of our business operations, as a result of patent infringement claims, which could harm our business.

There has been substantial litigation and other legal proceedings regarding patent and other intellectual property rights in the pharmaceutical and biotechnology industries. Although we are not currently a party to any patent litigation or any other adversarial proceeding, including any interference or derivation proceeding declared or instituted before the United States Patent and Trademark Office, regarding intellectual property rights with respect to our intended products, our product candidates and our technology, it is possible that we might become one in the future. We are not currently aware of any actual or reasonably foreseeable third partythird-party infringement claim involving our product candidates. The cost to us of any patent litigation or other proceeding, even if resolved in our favor, could be substantial. The outcome of patent litigation is subject to uncertainties that cannot be adequately quantified in advance, including the dispute forum, demeanor and credibility of witnesses and the identity of the adverse party, especially in pharmaceutical and biotechnology related patent cases that might turn on the testimony of experts as to technical facts upon which experts might reasonably disagree. Some of our competitors might be able to sustain the costs of such litigation or proceedings more effectively than we can because of their substantially greater financial resources. If a patent or other proceeding is resolved against us, we might be enjoinedencouraged fromby researching, developing, manufacturing or commercializing our intended products or our product candidates without a license from the other party and we might be held liable for significant damages. We might not be able to obtain any required license on commercially acceptable terms or at all.

Risks Related to Commercialization of Our Current Product Candidate and Future Product Candidates Our commercial success depends upon attaining significant market acceptance of our current product candidate and future product candidates, if approved, among physicians, patients, healthcare payors and cancer treatment centers.

Our relationships with customers and third partythird-party payors will be subject to applicable anti-kickback, fraud and abuse and other healthcare laws and regulations, which could expose us to criminal sanctions, civil penalties, contractual damages, reputational harm and diminished profits and future earnings. If we or they are unable to comply with these provisions, we might become subject to civil and criminal investigations and proceedings that could have a material adverse effect on our business, financial condition and prospects.

Healthcare providers, physicians and third partythird-party payors will play a primary role in the recommendation and prescription of any product candidates for which we obtain regulatory approval. Our current and future arrangements with healthcare providers, healthcare entities, third party payors and customers might expose us to broadly applicable fraud and abuse and other healthcare laws and regulations that might constrain the business or financial arrangements and relationships through which we research, develop and will market, sell and distribute our intended product. As a pharmaceutical company, even though we do not and will not control referrals of healthcare services or bill directly to Medicare, Medicaid or other third partythird-party payors, federal and state healthcare laws and regulations pertaining to fraud and abuse and patients’ rights are applicable to our business. Restrictions under applicable federal and state healthcare laws and regulations that might affect our ability to operate include the following:

We rely to a large extent upon sophisticated information technology systems to operate our business. In the ordinary course of business, we collect, store and transmit large amounts of confidential information (including, but not limited to, personal information and intellectual property). The size and complexity of our information technology and information security systems, and those of our third partythird-party vendors with whom we might contract, make such systems potentially vulnerable to service interruptions or to security breaches from inadvertent or intentional actions by our employees or vendors, or from malicious attacks by third parties. Such attacks are of ever-increasing levels of sophistication and are made by groups and individuals with a wide range of motives (including, but not limited to, industrial espionage and market manipulation) and expertise. While we intend to invest in the protection of data and information technology, there can be no assurance that our efforts will prevent service interruptions or security breaches.

As of March 14,31, 2025,2026, we had twothree officer/employees, our Chief Executive Officer andOfficer, our Chief Financial Officer, and oneour consultant, our Chief Medical Scientific Officer. The Company relies to a significant extent on outside consultants and advisors with various technical skills and expertise that the Company can draw on as necessary to conduct its research and development and clinical trial programs. We might need to grow the size of our organization in order to support our continued development and potential commercialization of our lead product candidate. As our development and commercialization plans and strategies continue to develop, our need for additional managerial, operational, manufacturing, sales, marketing, financial and other resources might increase. Our management, personnel and systems currently in place might not be adequate to support this future growth. Future growth would impose significant added responsibilities on members of management, including:

The Company is a clinical-stage biopharmaceutical company focused on identifying new targets for cancer drug development and developing and and commercializing cancer therapies. The Company is the majority shareholder of Liora Technologies Europe Ltd., which is pioneering the development of electronically controlled proton therapy systems for treating tumors in various types of cancers. The Company’s corporate office is located in Pasadena,Boca California.Raton, Florida.

February 25, 2025- The Company announced that it had added the Robert H. Lurie Comprehensive Cancer Center (Lurie Cancer Center) of Northwestern University as a second site in a clinical trial combining the Company’s proprietary compound LB-100 with GSK’s dostarlimab to treat ovarian clear cell cancer.

For the year ended December 31, 2024,2025, the Company recordedincurred a net loss of $3,585,965$6,009,520 and used cash in operations of $3,164,536.$3,070,618. AtAs of December 31, 2024,2025, the Company had cash of $1,038,952$5,106,872 available to fund its operations. Subsequently, theThe Company completedhas a securities offering thatnot generated grossrecurring proceedsrevenues of $1,050,003 during February 2025 before deducting the placement agent’s feessince inception and relatedhas offering expenses.incurred negative operating cash flows as it advances its clinical development programs.

BecauseThe the Company is currently engaged in various early-stage clinical trials,trials itfor isits expected that it will take a significant amount of time and resources to develop anylead product orcandidate, intellectualLB-100. propertyThese capableactivities ofrequire generatingsubstantial research, sustainabledevelopment, revenues.regulatory, Accordingly,and clinical expenditures, and the Company’s businessCompany isdoes unlikelynot expect to generate any sustainable operating revenues in the next for several years and may never do so. Evenyears, if the Company is able to generate revenues through licensing its technology, product sales or other commercial activities, there can be no assurance that the Company will be able to achieve and maintain positive earnings and operating cash flows.ever. At March 14,31, 2025,2026, the Company’s remaining financial contractual commitments pursuant to clinical trial agreements and clinical trial monitoring agreements not yet incurred aggregated approximately $526,000,$496,000, which are currently scheduledexpected to be incurred through approximately December 31, 2027.

The Company’s common stock and the warrants areis traded on the Nasdaq Capital Market under the symbolssymbol “LIXT” and “LIXTW”, respectively..

Research and development costs are charged to expense as incurred. The costs of equipment that are acquired or constructed for research and development activities, and have alternative future uses, are classified as property and equipment and depreciated over their estimated useful lives. Research and development costs consist primarily of fees paid to consultants and contractors, and other expenses relating to the negotiation, design, development, conduct and management of clinical trials with respect to the Company’s clinical compound and product candidate. Research and development costs also include the costs to manufacture compounds used in research and clinical trials, which are charged to operations as incurred. The Company’s inventory of LB-100 for clinical use has been manufactured separately in the United States and in the European Union in accordance with the laws and regulations of such jurisdictions.

Obligations incurred with respect to mandatory scheduled payments under agreements with milestone provisions are recognized as charges to research and development costs in the Company’s consolidated statement of operations based on the achievement of such milestones, as specified in the respective agreement. Obligations incurred with respect to mandatory scheduled payments under agreements without milestone provisions are accounted for when due, are recognized ratably over the appropriate period, as specified in the respective agreement, and are recorded as liabilities in the Company’s consolidated balance sheet, with a corresponding charge to research and development costs in the Company’s consolidated statement of operations.agreement.

The Company accounts for warrants as either equity-classified or liability-classified instruments based on an assessment of the warrant’s specific terms and applicable authoritative guidance in Accounting Standards Codification (“ASC”) 480, Distinguishing Liabilities from Equity (“ASC 480”), and ASC 815, Derivatives and Hedging (“ASC 815”). The assessment considers whether the warrants are freestanding financial instruments pursuant to ASC 480, meet the definition of a liability pursuant to ASC 480, and whether the warrants meet all of the requirements for equity classification under ASC 815, including whether the warrants are indexed to the Company’s own common stock and whether the warrant holders could potentially require “net cash settlement” in a circumstance outside of the Company’s control, among other conditions for equity classification. The Company has determined that the warrants issued in the July 20, 2023 equity financing meet the requirements for equity classification. This assessment, which requires the use of of professional judgment, is conducted when the warrants are issued and at the end each subsequent quarterly period while the warrants are are outstanding. For issued or modified warrants that meet all of the criteria for equity classification, the warrants are required to be be recorded as a component of additional paid-in capital at the time of issuance. For issued or modified warrants that do not meet all of of the criteria for equity classification, the warrants are required to be liability-classified and recorded at their initial fair value on the date of issuance and remeasured at fair value at each balancereporting sheetdate. dateEffective thereafter.November Changes28, in2025, the estimatedCompany fairdelisted valueits of thepublic warrants that aretraded liability-classified are recognized as a non-cash gain or loss inunder the statementsymbol of operations at each balance sheet date.“LIXTW”. At December 31, 20242025 and 2023,2024, the Company did not have any liability-classified warrants.

The Company is a clinical-stage biopharmaceutical and proton cancer therapy company focused on identifying new targets for cancer drug development and developing and commercializing cancer therapies. The Company’s product pipeline is primarily focused on inhibitors of protein phosphatase 2A, which is used to enhance cytotoxic agents, radiation, immune checkpoint blockers and other cancer therapies. The Company believes that inhibitors of protein phosphatases have significant therapeutic potential for a broad range of cancers. The Company is focusing on the clinical development of a specific protein phosphatase inhibitor, referred to as LB-100, which has been shown to have clinical anti-cancer activity.

Given the identified adverse events in the two patients in the clinical trial, the IRB requested from the principal investigator of the study at the NKI information as to whether the adverse events could have been caused by the combination of LB-100 and atezolizumab and information about the mode of action of the combination of LB-100 and atezolizumab. The principal investigator ishas preparingprepared a response to the IRB detailing the safety experience with LB-100 given alone and in combination with other cancer drugs, especially doxorubicin and dostarlimab. Doxorubicin is a well-known chemotherapy, and dostarlimab is a well-known immunotherapy of which the mode of action is closely related to that of atezolizumab.

The reported adverse events in the colorectal cancer study have not been seen in any other patients thus far treated with LB-100 alone or in combination with other cancer drugs. Through February 2025, a total of 78 patient have received or are receiving experimental treatment with LB-100. ItThe investigators have completed the IRB review in Q4 2025 and the trial is expectedopen thatagain itfor willenrolment takeQ1 at least two months to prepare a detailed response to the IRB, during which time the Company intends to update the safety overview of LB-100.2026.

This Quarterly Report on Form 10-Q of Nomad Power Solutions, Inc. (f/k/a Lixte Biotechnology Holdings, Inc.) (the “Company”) contains certain forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, and Section 21E of the Securities Exchange Act of 1934. These might include statements regarding the Company’s financial position, business strategy and other plans and objectives for future operations, and assumptions and predictions about future clinical trials and their timing and costs, product demand, supply, manufacturing costs, marketing and pricing factors are all forward-looking statements. These statements are generally accompanied by words such as “intend”, “anticipate”, “believe”, “estimate”, “potential(ly)”, “continue”, “forecast”, “predict”, “plan”, “may”, “will”, “could”, “would”, “should”, “expect” or the negative of such terms or other comparable terminology. The Company believes that the assumptions and expectations expectations reflected in such forward-looking statements are reasonable, based on information available to it on the date hereof, but the Company cannot provide assurances that these assumptions and expectations will prove to have been correct or that the Company will take any action that the Company may presently be planning. These forward-looking statements are inherently subject to known and unknown risks and uncertainties. Actual results or experience may differ materially from those expected, anticipated or implied in the forward-looking statements. Factors that could cause or contribute to such differences include, but are not limited to, regulatory policies or changes thereto, available cash, research and development results, competition from other similar businesses, and market and general economic factors. This discussion should be read in conjunction with the condensed consolidated financial statements and notes thereto included in Item 1 of this Quarterly Report on Form 10-Q and the Company’s Annual Report on Form 10-K for the fiscal year ended December 31, 2024,2025, including the section entitled “Item 1A. Risk Factors”. The Company does not intend to update or revise any forward-looking statements to reflect new information, future events or otherwise.

The Company is a clinical-stage biopharmaceutical company focused on identifying newnovel targets for cancer drug development and developing and and commercializing cancer therapies. The Company’s corporate office is located in Pasadena, California.

The Company’s productproduct-development pipelineactivities isare primarily focused on inhibitors of protein phosphatase 2A,2A which(“PP2A”). isThe Company usedbelieves toPP2A inhibitors may enhance the effectiveness of cytotoxic agents, radiation, radiation therapy, immune checkpoint blockersinhibitors and other cancer therapies.treatments. The CompanyCompany’s believesprincipal thatproduct inhibitorscandidate ofis protein phosphatases have significant therapeutic potential forLB-100, a broadPP2A rangeinhibitor ofcurrently cancers. The Company is focusing on theundergoing clinical development of a specific protein phosphatase inhibitor, referred to as LB-100.development.

The Company’s activitiesoperations are subject to significant risks and uncertainties, including theits need forto obtain additional capital. The Company has not yet commenced any revenue-generating operations, doeshas not havegenerated positive cash flows from operations,operations reliesand relies, in part, on stock-based compensation compensation forto acompensate substantial portion of employeeemployees and consultantconsultants. compensation,The andCompany is dependent on periodic access to equity or debt financing and other sources of capital to fund its operating requirements.requirements and clinical-development programs.

The Company is currently engaged inconducting early-stage clinical trials for its lead product candidate,involving LB-100. These activities require substantial expenditures for research, research, development, regulatory,regulatory compliance and clinical expenditures,activities. and theThe Company does not expect to generate sustainable operating revenuesrevenue for for several years, if ever. At March 31, 2026, the Company’s remaining contractual commitments pursuant to clinical trial agreements and clinical trial monitoring agreements aggregated approximately $482,702 which are expected to be incurred through December 31, 2027.

InAs addition,of June 30, 2026, the Company’s remaining contractual commitments under clinical trial and clinical trial monitoring agreements totaled approximately $170,520 and are expected to be incurred through theDecember acquisition31, of2027. Liora,In addition, the Company expects to incur approximately $2 $2.0 million over the next 24 months to recommission and update the LightLiGHT machine.system equipment. Liora currently has no revenues,revenue, and the Company will require additional capital to fund these activities.

Management iscontinues activelyto evaluatingevaluate and pursuing additionalpursue financing alternatives, including equity and debt financingfinancings and potential strategic transactions. There However, there can be no assurance that additional fundingcapital will be available when needed, on acceptable terms,terms or in amounts sufficient amounts, or at all. If the Company is unable to obtainfund the necessary funding, it may be required to delay, scale back, or eliminate its clinical developmentCompany’s programs; curtail expenditures related to the LiGHT system; or pursue strategic alternatives, including potential asset sales or the cessation of operations.

The Company’s common stock areis traded on the Nasdaq Capital Market under the symbol “LIXTNMAD”.

The Company remainsremained subject to a Panel Monitor under Nasdaq Listing Rule 5815(d)(4)(B) through July 15, 2026. During thisthe monitoring period, any future subsequent deficiency inunder stockholders’the equityStockholders’ Equity Requirement would requirehave required the Company to request a hearing before the Panel rather than submit a new compliance plan. plan to Nasdaq. There was no subsequent deficiency through July 15, 2026.

Information withregarding respectrecently to recentissued accounting pronouncements is providedincluded atin Note 2 to the condensed consolidated financial statements for the three three and six months ended MarchJune 31,30, 2026 and 2025 included elsewhere in this document.Quarterly Report.

The Company’s significant accounting policies are described in Note 2 to the condensed consolidated financial statements for the three and six months ended MarchJune 31,30, 2026 and 2025 included elsewhere in this document.Quarterly Report. These policies, together with the relatedestimates and estimatesassumptions and assumptions,used in their application, are fundamentalimportant to an understanding of the Company’s financial condition and results of operations and financial condition. Management evaluates these policies and estimates on an ongoing basis based on historical experience, current conditions, and other factors deemed relevant.operations.

There have been no material changes to the Company’s critical accounting policies and estimates from those disclosed in the Company’sits most recent Annual Report on Form 10-K.

TheAn occurrence of an SAE andor any resultingrelated clinical hold could also harmadversely affect the Company’s reputation withamong patients, physicians,investigators, healthmedical institutions institutions,and investors; impede patient recruitment; and investors, diminishimpair the Company’s ability to attract clinical trial participants, and damage the Company’s ability to interest investors and obtain financing inor theenter future.into strategic arrangements. There can be no assurancesassurance that theadditional CompanySAEs will not experience such SAEs in the futureoccur or that any related clinical hold will be lifted in a timely manner,manner or at all.

GivenThe the identified adverse events in the two patients in the clinical trial, theNKI IRB requested additional information from the principal investigator of the study at the NKI information as toregarding whether the adverse events couldmay have been caused by the combination of LB-100 and atezolizumab and information about the modepotential mechanism of action of the combination of LB-100 and atezolizumab.combination. The principal investigator prepared submitted a response todescribing the IRB detailing the safety experience with LB-100 givenadministered alone and in combination with other cancer drugs,therapies, especially including doxorubicin and dostarlimab. Doxorubicin is a well-known chemotherapy, and dostarlimab is a well-known immunotherapy of which the mode of action is closely related to that of atezolizumab.

The reported adverse events reported in the colorectal cancer studytrial havehad not been seenobserved in any other patients thus far treated with LB-100LB-100, either alone or in in combination with other cancer drugs.therapies. ThroughAs of early July 2025, the Company hashad been informed that a total ofapproximately 82 patients had received or were receiving experimental treatment withinvolving LB-100.

In May 2025, the Company updated the safety overviewinformation ofrelating to LB-100 and delivereddistributed the updated versionVersion 5.0 of the Investigator’s Brochure (theto “IB”),investigators whichparticipating contains all ofin the relevant preclinical, clinical and pharmacologic data with respect to the study of the LB-100 clinical compound in humans, to the investigators of allCompany’s ongoing clinical trials. The investigatorsInvestigator’s Brochure includes relevant preclinical, clinical and pharmacological information concerning the administration of LB-100 to humans. The investigators conducting the study in colorectal cancer (NCT06012734)study, NCT06012734, submitted a detailed response to the IRB,NKI includingIRB that included the updated IB.Investigator’s Brochure. The Company is currently awaiting thecompletion outcome of the IRBIRB’s review.

InflationThe and Interest Rate Risk. The Company does not believe that inflation or increasingchanges in interest rates have had a material direct effect on its operations to date, other than thanthrough their impactbroader effects on the generaleconomy economy.and capital markets. However, thereinflationary ispressures acould risk thatincrease the Company’scosts of clinical trials, contract research, manufacturing, personnel and other operating costs could become subject to inflationary and interest rate pressures in the future, which would have the effect of increasing the Company’s operating costs, and which would put additional stress on the Company’s working capital resources.activities.