LIXTE BIOTECHNOLOGY HOLDINGS, INC.

Current report

For the three months ended March 31, 2026, the Company incurred a net loss of $1,987,608 and used cash in operations of $1,831,363. As of March 31, 2026, the Company had cash of $3,250,650 available to fund its operations. The Company has not generated recurring revenues since inception and has incurred negative operating cash flows as it advances its development programs. As a result, management has concluded that there is a substantial doubt regarding the Company’s ability to continue as a going concern for a period of at least 12 months beyond the filing of this quarterly report. In addition, our independent registered public accounting firm, in their audit report to the financial statements included in the Company’s Annual Report on Form 10-K for the year ended December 31, 2025, expressed substantial doubt about the Company’s ability to continue as a going concern. The condensed consolidated financial statements have been prepared assuming the Company will continue as a going concern and do not include any adjustments that might result from the outcome of this uncertainty.

Current report

The Company is currently engaged in early-stage clinical trials for its lead product candidate, LB-100. These activities require substantial research, development, regulatory, and clinical expenditures, and the Company does not expect to generate sustainable operating revenues 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.

Current report

In addition, through the acquisition of Liora, the Company expects to incur approximately $2 million over the next 24 months to recommission and update the Light machine. Liora currently has no revenues, and the Company will require additional capital to fund these activities.

Current report

Management is actively evaluating and pursuing additional financing alternatives, including equity and debt financing and potential strategic transactions. However, there can be no assurance that additional funding will be available on acceptable terms, in sufficient amounts, or at all. If the Company is unable to obtain the necessary funding, it may be required to delay, scale back, or eliminate its clinical development programs; curtail expenditures related to the LiGHT system; or pursue strategic alternatives, including potential asset sales or the cessation of operations.

Current report

The Company’s significant accounting policies are described in Note 2 to the condensed consolidated financial statements for the three months ended March 31, 2026 and 2025 included elsewhere in this document. These policies, together with the related estimates and assumptions, are fundamental to understanding the Company’s 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.

Current report

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

Current report

Serious Adverse Events

Current report

**Supply Chain Issues.**The Company does not currently expect that supply chain issues will have a significant impact on its business activities, including its ongoing clinical trials.

Current report

The Company is continuing to monitor these matters and will adjust its current business and financing plans as more information becomes available.

Current report

Research and Development Costs. For the three months ended March 31, 2026, research and development costs were $333,376 which consisted of clinical and related oversight costs of $309,794 and compound maintenance costs of $5,516, and preclinical research focused on development of additional novel anti-cancer compounds to add to the Company’s clinical pipeline of $13,566.

Current report

For the three months ended March 31, 2025, research and development costs were $91,457, which consisted of clinical and related oversight costs of $15,868, compound maintenance costs of $32,819, and preclinical research focused on development of additional novel anti-cancer compounds to add to the Company’s clinical pipeline of $42,770.

Current report

Research and development expenses increased by $241,919, or 265%, in 2026 as compared to 2025. The increase was primarily attributable to a final payment related to clinical trial engagement which increased the cost by $293,297, partially offset by a decrease in compound maintenance costs of $56,507.

Current report

General and Administrative Costs. For the three months ended March 31, 2026, general and administrative costs were $1,654,031 which primarily consisted of Accounting fees of $413,504, Investment banking fees of $250,000, payroll expenses of $217,927, public relations fees of $178,500, consulting fees related to Liora acquisition of $172,572, legal fees of $37,590, lease expense of $145, 365, Insurance expense including D&O of $64,387, intellectual property costs of $35,032, listing fees of $14,000, Investor relations of $13,797, licenses and royalties of $7,500, and stock-based compensation to related parties of $82,176.

Current report

General and administrative costs increased by $1,038,548 or 169%, in 2026 as compared to 2025, primarily as a result of increase in accounting fees by $318,485, increase in investment banking fees by $221,140, increase in public relations costs by 178,500, consulting fees related to acquisition by $172,572, increase in lease expense by $145,365, increase in payroll expense by $127,162 partially offset by decrease in legal fees by $43,847, decrease in consulting fees supporting prior period activities with no equivalent services requested in current period, decrease in intellectual property by $21,052.

Current report

For the three months ended March 31, 2026, the Company incurred a net loss of $1,987,608 and used cash in operations of $1,831,363. As of March 31, 2026, the Company had cash of $3,250,650 available to fund its operations. The Company has not generated recurring revenues since inception and has incurred negative operating cash flows as it advances its development programs. As a result, management has concluded that there is a substantial doubt regarding the Company’s ability to continue as a going concern for a period of at least 12 months beyond the filing of this quarterly report. In addition, our independent registered public accounting firm, in their audit report to the financial statements included in the Company’s Annual Report on Form 10-K for the year ended December 31, 2025, expressed substantial doubt about the Company’s ability to continue as a going concern.

Previous report

For the nine months ended September 30, 2025, the Company recorded a net loss of $3,465,626 and used cash in operations of $1,982,720. At September 30, 2025, the Company had cash of $2,887,874 available to fund its operations.

Previous report

Because the Company is currently engaged in various early-stage clinical trials, it is expected that it will take a significant amount of time and resources to develop any product or intellectual property capable of generating sustainable revenues. Accordingly, the Company’s business is unlikely to generate any sustainable operating revenues in the next several years and may never do so. Even 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. At September 30, 2025, the Company’s remaining financial contractual commitments pursuant to clinical trial agreements and clinical trial monitoring agreements not yet incurred aggregated approximately $510,000, which are currently scheduled to be incurred through approximately December 31, 2027.

Previous report

The Company’s consolidated financial statements have been presented on the basis that it will continue as a going concern, which contemplates the realization of assets and satisfaction of liabilities in the normal course of business. The Company has no recurring source of revenues and has experienced negative operating cash flows since inception. The Company has financed its working capital requirements through the recurring sale of its equity securities. These factors raise substantial doubt about the Company’s ability to continue as a going concern within one year after the date the consolidated financial statements are issued. The consolidated financial statements also do not reflect any adjustments relating to the recoverability of assets and liabilities that might be necessary if the Company is unable to continue as a going concern.

Previous report

The Company’s ability to continue as a going concern is dependent upon its ability to raise additional equity capital to fund its research and development activities, including its ongoing clinical trials. The amount and timing of future cash requirements depends in substantial part on the pace, design and results of the Company’s clinical trial program, which, in turn, depends on the availability of operating capital to fund such activities.

Previous report

Based on current operating plans, the Company estimates that its existing cash resources at September 30, 2025 will provide sufficient working capital to fund the Company’s operations as currently configured, including its ongoing clinical trial program with respect to the development of the Company’s lead anti-cancer clinical compound LB-100, for at least the next 12 months. However, existing cash resources will not be sufficient to complete the development of and to obtain regulatory approval for the Company’s product candidate, which would require significant additional operating capital.

Previous report

In addition, as a result of the appointment of a new Chairman and Chief Executive Officer in June 2025, the completion of the July 2025 equity financings, and other recent changes in senior management and the Board of Directors, the Company’s operating strategies that may include the addition of personnel and/or the incurrence of additional operating costs, which may require that the Company raise additional capital to fund operations. However, as market conditions present uncertainty as to the Company’s ability to secure additional funds, there can be no assurances that the Company will be able to secure additional financing on acceptable terms, as and when necessary, to continue to fund its operations.

Previous report

The Company’s independent registered public accounting firm included an explanatory paragraph in their report with respect to this uncertainty that accompanied the Company’s audited consolidated financial statements as of and for the year ended December 31, 2024, in which they expressed substantial doubt about the Company’s ability to continue as a going concern. The Company’s consolidated financial statements do not include any adjustments that might result from the outcome of this uncertainty.

Previous report

If cash resources are insufficient to satisfy the Company’s ongoing cash requirements, the Company would be required to scale back or discontinue its clinical trial program, as well as its licensing and patent prosecution efforts and its technology and product development efforts, or obtain funds, if available, through strategic alliances, joint ventures or other transaction structures that could require the Company to relinquish rights to and/or control of LB-100, or to curtail or discontinue operations entirely.

Previous report

On June 2, 2023, the Company effected a 1-for-10 reverse split of its outstanding shares of common stock in order to remain in compliance with the $1.00 minimum closing bid price requirement of the Nasdaq Stock Market LLC (“Nasdaq”).

Previous report

On August 19, 2024, the Company received a letter from the Nasdaq Listing Qualifications Staff notifying the Company of its noncompliance with the minimum $2.5 million stockholders’ equity requirement for continued listing on the Nasdaq Capital Market under Rule 5550(b)(1).

Previous report

On October 3, 2024, the Company submitted a compliance plan, outlining proposed equity financings. On October 21, 2024, Nasdaq granted the Company an extension through February 18, 2025 to complete its plan and evidence compliance via Form 8-K.

Previous report

Concentration of Risk

Previous report

The preparation of financial statements in conformity with GAAP requires management to make estimates and assumptions that affect the reported amounts of assets and liabilities at the date of the financial statements and the reported amounts of expenses during the reporting period. Some of those judgments can be subjective and complex, and therefore, actual results could differ materially from those estimates under different assumptions or conditions. Management bases its estimates on historical experience and on various assumptions that are believed to be reasonable in relation to the financial statements taken, as a whole, under the circumstances, the results of which form the basis for making judgments about the carrying values of assets and liabilities that are not readily apparent from other sources. Management regularly evaluates the key factors and assumptions used to develop the estimates utilizing currently available information, changes in facts and circumstances, historical experience, and reasonable assumptions. After such evaluations, if deemed appropriate, those estimates are adjusted accordingly. Actual results could differ from those estimates. Significant estimates include those related to assumptions used in the calculation of accruals for clinical trial costs and other potential liabilities, and valuing equity instruments issued for services.

Previous report

The following critical accounting policies affect the more significant judgements and estimates used in the preparation of the Company’s consolidated financial statements.

Previous report

Cash

Previous report

Cash is held in a cash bank deposit program maintained by Morgan Stanley Wealth Management, a division of Morgan Stanley Smith Barney LLC (“Morgan Stanley”). Morgan Stanley is a FINRA-regulated broker-dealer. The Company’s policy is to maintain its cash balances with financial institutions in the United States with high credit ratings and in accounts insured by the Federal Deposit Insurance Corporation (the “FDIC”) and/or by the Securities Investor Protection Corporation (the “SIPC”). The Company periodically has cash balances in financial institutions in excess of the FDIC and SIPC insurance limits of $250,000 and $500,000, respectively. Morgan Stanley Wealth Management also maintains supplemental insurance coverage for the cash balances of its customers. The Company has not experienced any losses to date resulting from this policy.

Previous report

Segment Information

Previous report

The Company’s Chief Executive Officer is the Company’s Chief Operating Decision Maker (“CODM”) and evaluates performance and makes operating decisions about allocating resources based on internal financial data presented on a consolidated basis. Because the CODM evaluates financial performance on a consolidated basis, the Company has determined that it operates in a single reportable segment, which consists of the development of a drug class called Protein Phosphatase 2A inhibitors, and is comprised of the consolidated financial results of the Company. The CODM uses consolidated net income (loss) as the sole measure of segment profit or loss.

Previous report

In November 2023, the Financial Accounting Standards Board (“FASB”) issued Accounting Standards Update (“ASU”) 2023-07, Segment Reporting (Topic 280): Improvements to Reportable Segment Disclosure. ASU 2023-07 amends the FASB Accounting Standards Codification to require additional reportable segment disclosures of a public entity by requiring disclosure of significant segment expenses that are regularly provided to the chief operating decision maker, requiring other new disclosures, and requiring enhanced interim disclosures. ASU 2023-07 requires public entities with a single reportable segment to provide all the disclosures required by ASU 2023-07 and all existing segment disclosures in Topic 280 on an interim and annual basis. The Company adopted ASU 2023-07 effective January 1, 2024 for the 2024 annual period, including quarterly periods, on a retrospective basis.

Previous report

Research and Development

Previous report

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.

Previous report

Research and development costs are generally charged to operations ratably over the life of the underlying contracts, unless the achievement of milestones, the completion of contracted work, the termination of an agreement, or other information indicates that a different expensing schedule is more appropriate. However, payments for research and development costs that are contractually defined as non-refundable are charged to operations as incurred.

Previous report

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.

Previous report

Payments made pursuant to contracts are initially recorded as advances on research and development contract services in the Company’s consolidated balance sheet and are then charged to research and development costs in the Company’s consolidated statement of operations as those contract services are performed. Expenses incurred under contracts in excess of amounts advanced are recorded as research and development contract 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. The Company reviews the status of its various clinical trial and research and development contracts on a quarterly basis.

Previous report

Due to the significant uncertainty associated with the successful development of commercially viable products based on the Company’s research efforts and related patent applications, all patent and licensing legal and filing fees and costs related to the development and protection of the Company’s intellectual property are charged to operations as incurred. Patent and licensing legal and filing fees and costs are included in general and administrative costs in the Company’s consolidated statement of operations.

Previous report

In September 2023, the Company appointed a new President and Chief Executive Officer, who, with the assistance of the Company’s management, Board of Directors and patent legal counsel, conducted a comprehensive review and analysis of the Company’s patent portfolio in order to implement a program to balance patent prosecution costs with intellectual property protection benefits. As a result of such review and analysis, the Company identified certain patent filings that it decided not to continue to support in 2024 and thereafter. In addition, the Company changed patent legal counsel in mid-2024. The Company expects that patent and licensing legal and filing fees and costs will continue to be a significant continuing cost in 2025 and thereafter as the Company continues to manage its patent portfolio related to the clinical development of LB-100.

Previous report

As a result of such review and analysis, patent and licensing legal and filing fees and costs related to the development and protection of the Company’s intellectual property, primarily related to LB-100, decreased to $16,853 for the three months ended September 30, 2025, as compared to $45,415 for the three months ended September 30, 2024, a decrease of $28,562, or 62.9%. Patent and licensing legal and filing fees and costs related to the development and protection of the Company’s intellectual property, primarily related to LB-100, decreased to $90,239 for the nine months ended September 30, 2025, as compared to $192,238 for the nine months ended September 30, 2024, a decrease of $101,999, or 53.1%.

Previous report

A descriptive summary of the patent portfolio for the Company’s most important clinical programs involving the development of LB-100, as well as a detailed listing of each domestic and international patent that has been issued, is presented at “ITEM 1. BUSINESS – Intellectual Property” in the Company’s Annual Report on Form 10-K for the fiscal year ended December 31, 2024.

Previous report

Stock-Based Compensation

Previous report

The Company periodically issues common stock and stock options to officers, directors, employees, contractors and consultants for services rendered. Options vest and expire according to terms established at the issuance date of each grant. Stock grants, which are generally time vested, are measured at the grant date fair value and charged to operations ratably over the vesting period.

Previous report

The Company accounts for stock-based payments to officers, directors, employees, contractors, and consultants by measuring the cost of services received in exchange for equity awards utilizing the grant date fair value of the awards, with the cost recognized as compensation expense on the straight-line basis in the Company’s financial statements over the vesting period of the awards. Recognition of compensation expense for non-employees is in the same period and manner as if the Company had paid cash for the services.

Previous report

The fair value of stock options granted as stock-based compensation is determined utilizing the Black-Scholes option-pricing model, and is affected by several variables, the most significant of which are the expected life of the stock option, the exercise price of the stock option as compared to the fair market value of the common stock on the grant date, and the estimated volatility of the common stock. Unless sufficient historical exercise data is available, the expected life of the stock option is calculated as the mid-point between the vesting period and the contractual term (the “simplified method”). The estimated volatility is based on the historical volatility of the Company’s common stock, calculated utilizing a look-back period approximately equal to the contractual life of the stock option being granted. The risk-free interest rate is based on the U.S. Treasury yield curve in effect at the time of grant. The fair market value of the common stock is determined by reference to the quoted market price of the Company’s common stock on the grant date. The expected dividend yield is based on the Company’s expectation of dividend payouts and is assumed to be zero.

Previous report

The Company recognizes the fair value of stock-based compensation awards in general and administrative costs and in research and development costs, as appropriate, in the Company’s consolidated statements of operations. The Company issues new shares of common stock to satisfy stock option exercises.

Previous report

Warrants

Previous report

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 2023 equity financing, the February 2025 equity financing, and the July 2025 equity financings meet the requirements for equity classification. This assessment, which requires the use of professional judgment, is conducted when the warrants are issued and at the end each subsequent quarterly period while the warrants are outstanding. For issued or modified warrants that meet all of the criteria for equity classification, the warrants are required to 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 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 balance sheet date thereafter. Changes in the estimated fair value of the warrants that are liability-classified are recognized as a non-cash gain or loss in the statement of operations at each balance sheet date. At September 30, 2025 and December 31, 2024, the Company did not have any liability-classified warrants.

Previous report

Digital Assets

Previous report

The Company holds certain digital assets, consisting of Bitcoin and Ethereum cryptocurrencies. Digital assets are initially recorded at cost and if the fair value of a digital asset is other than its carrying amount, an unrealized gain or loss is recognized equal to the difference between the carrying amount and the fair value at the measurement date. Realized gains and losses on the sale of digital assets are included in other income (expense) in the Company’s consolidated statements of operations. The Company’s digital assets are reasonably expected to be realized in cash or sold or consumed during the Company’s normal operating cycle and as such have been classified as current assets in the Company’s consolidated balance sheets.

Previous report

The Company uses a combination of third-party custodial arrangements and cold storage solutions to secure its digital assets. While management believes these arrangements provide appropriate safeguards, digital assets are subject to unique risks, including technological failures, cybersecurity threats, loss of private keys, market volatility, and evolving legal and regulatory environments.

Previous report

Management monitors developments in accounting and regulatory guidance related to digital assets. Any future updates may require changes in the Company’s accounting policies, disclosures, or internal controls.

Previous report

Research and Development Costs. For the three months ended September 30, 2025, research and development costs were $50,696 which consisted of clinical and related oversight costs of $13,424, compound maintenance costs of $7,480, regulatory service costs of $7,581, and preclinical research focused on development of additional novel anti-cancer compounds to add to the Company’s clinical pipeline of $22,211.

Previous report — wording carried elsewhere

Following an April 3, 2025 hearing, the Panel granted the Company a further extension through July 3, 2025 to regain compliance.

Previous report — wording carried elsewhere

On July 2, 2025, the Company closed a $5.05 million private placement and, on July 8, 2025, completed a $1.5 million registered direct offering (see Note 5). On July 15, 2025, Nasdaq notified the Company that it had regained compliance with the stockholders’ equity requirement.

Previous report — wording carried elsewhere

Information with respect to concentration of risk is provided at Note 2 to the condensed consolidated financial statements for the three months and nine months ended September 30, 2025 and 2024 included elsewhere in this document.

Previous report — wording carried elsewhere

Revenues. The Company did not have any revenues for the nine months ended September 30, 2025 and 2024.

Previous report — wording carried elsewhere

Interest Expense. For the nine months ended September 30, 2025, the Company had interest expense of $5.402, as compared to interest expense of $12,389 for the nine months ended September 30, 2024, related to the financing of the premium for the Company’s directors and officers liability insurance policy.

Previous report — wording carried elsewhere

Realized Gain (Loss) on Foreign Currency Transactions. For the nine months ended September 30, 2025, the Company had a realized foreign currency gain of $530, as compared to a foreign currency loss of $3,119 for the nine months ended September 30, 2024, from foreign currency transactions.

Previous report — wording carried elsewhere

The Company is focusing on a disciplined approach to strategic expansion and is focused on advancing LB-100 in high-need cancer indications, while pursuing acquisitions of complementary oncology assets that could enhance the Company’s pipeline, accelerate development and create durable value for patients and shareholders. The Company has announced that it is in advanced negotiations regarding potential transactions consistent with its strategy, although there can be no assurance that any transaction will be completed.

Previous report — wording carried elsewhere

The Company’s lead drug candidate, LB-100, is currently undergoing various clinical trials, and there is a risk that one or more of these trials could be placed on hold by regulatory authorities due to serious adverse events (SAEs) related to the Company’s drug candidate or to another company’s drug used in combination in one of the Company’s clinical trials. It is possible that the SAEs could be attributable to the Company’s drug candidate and could include, but not be limited to, unexpected severe side effects, treatment-related deaths, or long-term health complications. A dose given could result in non-tolerable adverse events defined as dose-limiting toxicity (DLT). When two DLTs occur at the same dose-level that dose-level is considered too high and unsafe. Further treatment is only allowed at lower dose-levels that have previously been found safe.

Previous report — wording carried elsewhere

If an SAE or a pattern of SAEs is observed during the course of a clinical trial involving the Company’s drug candidate, the U.S. Food and Drug Administration (FDA), European Medicines Agency (EMA), or other regulatory authorities may issue a clinical hold, requiring the Company to pause or discontinue further enrollment and dosing in the Company’s clinical trial. It is also possible that the clinical trial could be terminated. Any of these actions could delay or halt the development of the Company’s drug candidate, increase development costs, and negatively impact the Company’s ability to ultimately achieve regulatory approval. Additionally, if an SAE is confirmed to be drug-related, the Company may be required to conduct additional studies, modify the study design, or abandon further development of the drug candidate altogether, which could materially impact the Company’s business, financial condition, and prospects.

Previous report — wording carried elsewhere

The occurrence of an SAE and any resulting clinical hold could also harm the Company’s reputation with patients, physicians, health institutions, and investors, diminish the Company’s ability to attract clinical trial participants, and damage the Company’s ability to interest investors and obtain financing in the future. There can be no assurances that the Company will not experience such SAEs in the future or that any related clinical hold will be lifted in a timely manner, or at all.

Previous report — wording carried elsewhere

The principal investigator of the colorectal study testing LB-100 in combination with atezolizumab (Roche PD-L1 inhibitor) is currently investigating two SAEs observed in the clinical trial that was launched in August 2024. The Institutional Review Board (the “IRB”) of the Netherlands Cancer Institute (“NKI”) has put the colorectal cancer study on hold. The adverse reactions that developed in the two patients were dyspnea (shortness of breath) due to lung toxicity possibly or probably related to the combination of LB-100 and atezolizumab in one patient and fever and aphasia possibly or probably related to the combination of LB-100 and atezolizumab in the second patient. The patient who developed lung toxicity deceased due to the combination of lung metastases of colorectal cancer and dyspnea. The patient with fever and aphasia fully recovered from the adverse events with supportive medication.

Previous report — wording carried elsewhere

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 prepared 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.

Previous report — wording carried elsewhere

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 September 30,2025, the Company has been informed that a total of 86 patients had received or were receiving experimental treatment with LB-100.

Previous report — wording carried elsewhere

In May 2025, the Company updated the safety overview of LB-100 and delivered the updated version 5.0 of the Investigator’s Brochure (the “IB”), which contains all of the relevant preclinical, clinical and pharmacologic data with respect to the study of the LB-100 clinical compound in humans, to the investigators of all ongoing clinical trials. The investigators of the study in colorectal cancer (NCT06012734) submitted a detailed response to the IRB, including the updated IB. The Company is currently awaiting the outcome of the IRB review.

Previous report — wording carried elsewhere

Covid-19 Virus. The global outbreak of the novel coronavirus (Covid-19) in early 2020 led to disruptions in general economic activities throughout the world as businesses and governments implemented broad actions to mitigate this public health crisis. Although the Covid-19 outbreak has subsided, the extent to which the coronavirus or any other pandemics may reappear and impact the Company’s clinical trial programs and capital raising efforts in the future is uncertain and cannot be predicted.

Previous report — wording carried elsewhere

**Inflation and Interest Rate Risk.**The Company does not believe that inflation or increasing interest rates have had a material effect on its operations to date, other than their impact on the general economy. However, there is a risk that the Company’s 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.

Previous report — wording carried elsewhere

**Potential Recession.**There have been some indications that the United States economy may be at risk of entering a recessionary period. Although it does not appear likely at this time, an economic recession could impact the general business environment and the capital markets, which could, in turn, affect the Company.

Previous report — wording carried elsewhere

Geopolitical Risk. The geopolitical landscape poses inherent risks that could significantly impact the operations and financial performance of the Company. In the event of a military conflict, supply chain disruptions, geopolitical uncertainties, and economic repercussions may adversely affect the Company’s ability to conduct research, develop, test and manufacture products, and distribute them globally. This could lead to delays in product development, interruptions in the supply of critical materials, and delays in clinical trials, thereby impeding the Company’s clinical development and commercialization plans. Furthermore, the impact of a conflict on global financial markets may result in increased volatility and uncertainty in the capital markets, thereby affecting the valuation of the Company’s publicly-traded shares. Investor confidence, market sentiment, and access to capital could all be negatively influenced. Such geopolitical risks are outside the control of the Company, and the actual effects on the Company’s business, financial condition and results of operations may differ from current estimates.

Previous report — wording carried elsewhere

**Cybersecurity Risks.**The Company has established policies and processes for assessing, identifying and managing material risk from cybersecurity threats, and has integrated these processes into its overall risk management systems and processes. The Company routinely assesses material risks from cybersecurity threats, including any potential unauthorized occurrence on or conducted through its information and email systems that may result in adverse effects on the confidentiality, integrity, or availability of the Company’s information and email systems or any information residing therein. The Company conducts periodic risk assessments to identify cybersecurity threats, as well as assessments in the event of a material change in the Company’s business practices that may affect information systems that are vulnerable to such cybersecurity threats. These risk assessments include identification of reasonably foreseeable internal and external risks, the likelihood and potential damage that could result from such risks, and the sufficiency of existing policies, procedures, systems and safeguards in place to manage such risks. The Company has not encountered any cybersecurity challenges to date that have materially impaired its operations or financial condition.

Previous report — wording carried elsewhere

The Company is focusing on a disciplined approach to strategic expansion and is focused on advancing LB-100 in high-need cancer indications, while pursuing acquisitions of complementary oncology assets that could enhance the Company’s pipeline, accelerate development and create durable value for patients and shareholders. The Company has announced that it is in advanced negotiations regarding potential transactions consistent with its strategy, although there can be no assurance that any transaction will be completed.