Lixte Biotechnology Holdings Inc.
11/12/2025 | Press release | Distributed by Public on 11/12/2025 15:26
Quarterly Report for Quarter Ending September 30, 2025 (Form 10-Q)
MANAGEMENT'S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS OF OPERATIONS
Forward-Looking Statements
This Quarterly Report on Form 10-Q of 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 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, 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.
Overview
The Company is a clinical-stage biopharmaceutical company focused on identifying new targets for cancer drug development and developing and commercializing cancer therapies. The Company's corporate office is located in Pasadena, California.
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.
The Company's activities are subject to significant risks and uncertainties, including the need for additional capital. The Company has not yet commenced any revenue-generating operations, does not have positive cash flows from operations, relies on stock-based compensation for a substantial portion of employee and consultant compensation, and is dependent on periodic access to equity capital to fund its operating requirements.
Going Concern
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.
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.
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.
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.
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.
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.
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.
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.
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.
Nasdaq Compliance
The Company's common stock and public warrants are traded on the Nasdaq Capital Market under the symbols "LIXT" and "LIXTW", respectively.
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").
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).
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.
The Company did not meet the terms of the extension and, on February 19, 2025, received a Staff determination letter. The Company timely requested a hearing before the Nasdaq Hearings Panel, staying any suspension or delisting pending the Panel's decision.
Following an April 3, 2025 hearing, the Panel granted the Company a further extension through July 3, 2025 to regain compliance.
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.
The Company remains subject to a Panel Monitor under Nasdaq Listing Rule 5815(d)(4)(B) through July 15, 2026. During this period, any future deficiency in stockholders' equity would require the Company to request a hearing before the Panel rather than submit a new compliance plan.
Recent Accounting Pronouncements
Information with respect to recent accounting pronouncements 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.
Concentration of Risk
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.
Critical Accounting Policies and Estimates
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.
The following critical accounting policies affect the more significant judgements and estimates used in the preparation of the Company's consolidated financial statements.
Cash
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.
Segment Information
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.
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.
Research and Development
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.
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.
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.
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.
Patent and Licensing Legal and Filing Fees and Costs
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.
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.
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%.
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.
Stock-Based Compensation
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.
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.
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.
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.
Warrants
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.
Digital Assets
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.
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.
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.
Summary of Business Activities and Plans
Company Overview
The Company is a clinical-stage biopharmaceutical 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.
The Company believes that the mechanism by which LB-100 affects cancer cell growth is different from cancer agents currently approved for clinical use. LB-100 is currently being tested in clinical trials in Ovarian Clear Cell Carcinoma, Metastatic Colon Cancer, and Advanced Soft Tissue Sarcoma. LB-100 has shown anti-cancer activity in animal models of glioblastoma multiforme, neuroblastoma, and medulloblastoma, all cancers of neural tissue. LB-100 has also been shown to enhance the effectiveness of commonly used anti-cancer drugs in animal models of melanoma, breast cancer and sarcoma. The enhancement of anti-cancer activity of these anti-cancer drugs occurs at doses of LB-100 that do not significantly increase toxicity in animals. It is therefore hoped that, when combined with standard anti-cancer regimens against many tumor types, LB-100 will improve therapeutic benefit.
As a compound moves through the FDA-approval process, it becomes an increasingly valuable property, but at a cost of additional investment at each stage. As the potential effectiveness of LB-100 has been documented at the clinical trial level, the Company has allocated resources to manage its patent portfolio. The Company's approach has been to operate with a minimum of overhead, moving compounds forward as efficiently and inexpensively as possible, and to raise funds to support each of these stages as certain milestones are reached. The Company's longer-term objective is to secure one or more strategic partnerships or licensing agreements with pharmaceutical companies with major programs in cancer.
Specific Risks Associated with the Company's Business Activities
Serious Adverse Events
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.
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.
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.
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.
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.
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 early July 2025, the Company has been informed that a total of 82 patients had received or were receiving experimental treatment with LB-100.
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.
External Risks Associated with the Company's Business Activities
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 Covid-19 outbreak has subsided, the extent to which the coronavirus pandemic may reappear and impact the Company's clinical trial programs and capital raising efforts in the future is uncertain and cannot be predicted.
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.
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.
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.
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.
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.
The Company is continuing to monitor these matters and will adjust its current business and financing plans as more information becomes available.
Results of Operations
At September 30, 2025, the Company had not yet commenced any revenue-generating operations, does not have any positive cash flows from operations, and is dependent on its ability to raise equity capital to fund its operating requirements.
The Company's condensed consolidated statements of operations as discussed herein are presented below.
| Three Months Ended | Nine Months Ended | |||||||||||||||
| September 30, | September 30, | |||||||||||||||
| 2025 | 2024 | 2025 | 2024 | |||||||||||||
| Revenues | $ | - | $ | - | $ | - | $ | - | ||||||||
| Costs and expenses: | ||||||||||||||||
| Research and development costs | 50,696 | 361,630 | 202,801 | 691,402 | ||||||||||||
| General and administrative costs | 1,750,658 | 621,627 | 3,080,302 | 2,267,890 | ||||||||||||
| Total costs and expenses | 1,801,354 | 983,257 | 3,283,103 | 2,959,292 | ||||||||||||
| Loss from operations | (1,801,354 | ) | (983,257 | ) | (3,283,103 | ) | (2,959,292 | ) | ||||||||
| Interest income | 4,430 | 1,437 | 5,236 | 6,529 | ||||||||||||
| Interest expense | (457 | ) | (1,049 | ) | (5,402 | ) | (12,389 | ) | ||||||||
| Unrealized gain (loss) in fair value of digital assets, net | (182,887 | ) | - | (182,887 | ) | - | ||||||||||
| Realized gain (loss) on foreign currency transactions | (130 | ) | (3,161 | ) | 530 | (3,119 | ) | |||||||||
| Net loss | (1,980,398 | ) | (986,030 | ) | (3,465,626 | ) | (2,968,271 | ) | ||||||||
| Series B Convertible Preferred Stock 8% cumulative dividend | (50,367 | ) | - | (50,367 | ) | - | ||||||||||
| Net loss attributable to common stockholders | $ | (2,030,765 | ) | $ | (986,030 | ) | $ | (3,515,993 | ) | $ | (2,968,271 | ) | ||||
| Net loss per common share - basic and diluted | $ | (0.33 | ) | $ | (0.44 | ) | $ | (0.92 | ) | $ | (1.32 | ) | ||||
| Weighted average common shares outstanding - basic and diluted | 6,171,195 | 2,249,290 | 3,801,400 | 2,249,290 | ||||||||||||
Three Months Ended September 30, 2025 and 2024
Revenues. The Company did not have any revenues for the three months ended September 30, 2025 and 2024.
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.
For the three months ended September 30, 2024, research and development costs were $361,630, which consisted of clinical and related oversight costs of $250,342, compound maintenance costs of $9,062, regulatory service costs of $11,405, and preclinical research focused on development of additional novel anti-cancer compounds to add to the Company's clinical pipeline of $90,821.
Included in preclinical research costs for the three months ended September 30, 2025 and 2024 were $0 and $76,278, respectively, of costs paid to the Netherlands Cancer Institute. On October 8, 2021, the Company entered into a Development Collaboration Agreement with the Netherlands Cancer Institute, Amsterdam, one of the world's leading comprehensive cancer centers, and Oncode Institute, Utrecht, a major independent cancer research center, to identify the most promising drugs to be combined with LB-100, and potential LB-100 analogues, to be used to treat a range of cancers, as well as to identify the specific molecular mechanisms underlying the identified combinations.
On October 3, 2023, the Company entered into Amendment No. 2 to the Development Collaboration Agreement with the Netherlands Cancer Institute, which provided for additional research activities, extended the termination date of the Development Collaboration Agreement by two years to October 8, 2026, and added 500,000 Euros to the operating budget being funded by the Company.
On October 4, 2024, the Company entered into Amendment No. 3 to the Development Collaboration Agreement with NKI, which suspended Amendment No. 2 and provided for a new study term of one year commencing upon the dosing of the first patient in the clinical trial at a project cost of 100,000 Euros (see "Principal Commitments - Other Significant Agreements and Contracts - Netherlands Cancer Institute" below). The Company was recently notified that the preparations for this clinical trial were suspended and the clinical trial is not expected commence. Accordingly, the Company expects that this agreement will be terminated and the Company will have no further financial commitment or cost.
Research and development costs decreased by $310,934, or 86.0%, in 2025 as compared to 2024, primarily as a result of a decrease in clinical and related oversight costs of $236,918 and preclinical research focused on development of additional novel anti-cancer compounds to add to the Company's clinical pipeline of $68,610.
General and Administrative Costs. For the three months ended September 30, 2025, general and administrative costs were $1,750,658, which consisted of the fair value of vested stock options issued to directors and officers of $776,611 (including the vested portion of stock options granted to Geordan Pursglove, the Company's CEO, on July 3, 2025 of $546,499, the vested portion of stock options granted to Peter Stazzone, the Company's CFO, on September 1, 2025 of $55,732, and the vested portion of stock options granted to two new directors on August 15, 2025 of $76,010), patent and licensing legal and filing fees and costs of $16,853, other consulting and professional fees of $538,218 (including public relation fees of $184,711 paid to MicroCap Advisory LLC and $150,000 paid to IR Agency LLC), insurance expense of $64,277, travel expense of $40,320, officer compensation and related costs of $207,377, director fees paid in cash of $27,500, licensing and royalties of $7,397, shareholder reporting costs of $27,566, listing fees of $13,250, filing fees of $6,211, investor relations of $13,397, taxes and licenses of $5,056, and other operating costs of $6,625.
For the three months ended September 30, 2024, general and administrative costs were $621,627, which consisted of the fair value of vested stock options issued to directors and officers of $106,827 (including quarterly director and board committee fees of $27,500), patent and licensing legal and filing fees and costs of $45,415, other consulting and professional fees of $117,893, insurance expense of $116,440, officer compensation and related costs of $190,445, licensing and royalties of $7,537, shareholder reporting costs of $2,941, listing fees of $12,375, filing fees of $2,864, investor relations of $13,397, rent of $3,218, and other operating costs of $2,275.
General and administrative costs increased by $1,129,031 or 181.6%, in 2025 as compared to 2024, primarily as a result of increases in the fair value of vested stock options issued to directors and officers of $669,784 (including the vested portion of stock options granted to Geordan Pursglove, the Company's CEO, on July 3, 2025 of $546,499, the vested portion of stock options granted to Peter Stazzone, the Company's CFO, on September 1, 2025 of $55,732, and the vested portion of stock options granted to two new directors on August 15, 2025 of $76,010), other consulting and professional fees of $420,325 (including public relation fees of $184,711 paid to MicroCap Advisory LLC and $150,000 paid to IR Agency LLC), officer compensation and related costs of $16,932, travel expenses of $40,320, director fees paid in cash of $27,500, shareholder reporting of $24,645, taxes and licenses of $5,056, offset by decreases in patent and licensing legal and filing fees and costs of $28,562, and insurance expense of $52,163.
Effective August 4, 2025, the Company entered into a Market Awareness Agreement (the "Agreement") with MicroCap Advisory, LLC for a term of six months to develop a clear, impactful, and marketable corporate strategy to identify, reach and engage with potential investors. Following the initial 30 day term of the Agreement, either party may terminate it without cause by providing the other party with at least 15 days prior written notice. This corporate strategy was intended to serve as the foundation for a comprehensive investor communications program for the Company. The Agreement provided for a one-time account set-up fee of $15,000 and a cash fee of $125,000 per month over a period of six months, subject to increase, depending on news, events, or other opportunities to amplify public awareness, which will be reviewed and approved by both parties. In addition, the Agreement provided for the issuance of 48,000 shares of the Company's common stock to MicroCap Advisory, LLC. upon its signing. The Company also agreed to reimburse MicroCap Advisory, LLC for any pre-approved expenses incurred, including analyst reports and travel expenses. Effective September 5, 2025, the Company terminated this Agreement and issued 9,181 shares of common stock, valued at $44,711, under the Agreement as settlement of the original 48,000 common share obligation.
Interest Income. For the three months ended September 30, 2025, the Company had interest income of $4,430, as compared to interest income of $1,437 for the three months ended September 30, 2024, related to the investment of the Company's cash resources.
Interest Expense. For the three months ended September 30, 2025, the Company had interest expense of $457, as compared to interest expense of $1,049 for the three months ended September 30, 2024, related to the financing of the premium for the Company's directors and officers liability insurance policy.
Unrealized Gain (Loss) in Fair Value of Digital Assets, Net. For the three months ended September 30, 2025, the Company had aa unrealized net loss from a decrease in the fair value of digital assets of $182,887.
Realized Gain (Loss) on Foreign Currency Transactions. For the three months ended September 30, 2025, the Company had a realized foreign currency loss of $130, as compared to a foreign currency loss of $3,161 for the three months ended September 30, 2024, from foreign currency transactions.
Net Loss. For the three months ended September 30, 2025, the Company incurred a net loss of $1,980,398, as compared to a net loss of $986,030 for the three months ended September 30, 2024.
Series B Convertible Preferred Stock 8% Cumulative Dividend. For the three months ended September 30, 2025, the Company recorded a Series B Convertible Preferred Stock dividend of $50,367.
Net Loss Attributable to Common Stockholders. For the three months ended September 30, 2025, the Company incurred a net loss attributed to common stockholders of $2,030,765, as compared to a net loss attributed to common stockholders of $986,030 for the three months ended September 30, 2024.
Nine Months Ended September 30, 2025 and 2024
Revenues. The Company did not have any revenues for the nine months ended September 30, 2025 and 2024.
Research and Development Costs. For the nine months ended September 30, 2025, research and development costs were $202,801 which consisted of clinical and related oversight costs of $40,894, compound maintenance costs of $60,563, regulatory service costs of $8,771, and preclinical research focused on development of additional novel anti-cancer compounds to add to the Company's clinical pipeline of $92,573.
For the nine months ended September 30, 2024, research and development costs were $691,402, which consisted of clinical and related oversight costs of $358,319, compound maintenance costs of $18,932, regulatory service costs of $14,021, and preclinical research focused on development of additional novel anti-cancer compounds to add to the Company's clinical pipeline of 300,130.
Included in preclinical research costs for the nine months ended September 30, 2025 and 2024 were $0 and $210,362, respectively, of costs paid to the Netherlands Cancer Institute. On October 8, 2021, the Company entered into a Development Collaboration Agreement with the Netherlands Cancer Institute, Amsterdam, one of the world's leading comprehensive cancer centers, and Oncode Institute, Utrecht, a major independent cancer research center, to identify the most promising drugs to be combined with LB-100, and potential LB-100 analogues, to be used to treat a range of cancers, as well as to identify the specific molecular mechanisms underlying the identified combinations.
On October 3, 2023, the Company entered into Amendment No. 2 to the Development Collaboration Agreement with the Netherlands Cancer Institute, which provided for additional research activities, extended the termination date of the Development Collaboration Agreement by two years to October 8, 2026, and added 500,000 Euros to the operating budget being funded by the Company.
On October 4, 2024, the Company entered into Amendment No. 3 to the Development Collaboration Agreement with NKI, which suspended Amendment No. 2 and provided for a new study term of one year commencing upon the dosing of the first patient in the clinical trial at a project cost of 100,000 Euros (see "Principal Commitments - Other Significant Agreements and Contracts - Netherlands Cancer Institute" below). The Company was recently notified that the preparations for this clinical trial were suspended and the clinical trial is not expected commence. Accordingly, the Company expects that this agreement will be terminated and the Company will have no further financial commitment or cost.
Research and development costs decreased by $488,601, or 70.7%, in 2025 as compared to 2024, primarily as a result of a decrease in clinical and related oversight costs of $317,425 and preclinical research focused on development of additional novel anti-cancer compounds to add to the Company's clinical pipeline of $207,557, offset by an increase in compound maintenance of $41,631.
General and Administrative Costs. For the nine months ended September 30, 2025, general and administrative costs were $3,080,302, which consisted of the fair value of vested stock options issued to directors and officers of $1,144,348 (including quarterly director and board committee fees of $55,000, the acceleration of the vesting of stock options held by Bas van der Baan of $167,460 as a result of the amendment of his employment contract on June 16, 2025, the vested portion of stock options granted to Geordan Pursglove, the Company's CEO, on July 3, 2025 of $546,499, the vested portion of stock options granted to Peter Stazzone, the Company's CFO, on September 1, 2025 of $55,732, and the vested portion of stock options granted to two new directors on August 15, 2025 of $76,010), patent and licensing legal and filing fees and costs of $90,239, other consulting and professional fees of $920,084 (including public relation fees of $184,711 paid to MicroCap Advisory LLC and $150,000 paid to IR Agency LLC), insurance expense of $192,830, travel expense of $40,754, officer compensation and related costs of $460,403, director fees paid in cash of $27,500, licensing and royalties of $22,192, shareholder reporting costs of $39,731, listing fees of $59,750, filing fees of $21,381, investor relations of $36,191, taxes and licenses of $15,169, and other operating costs of $9,729.
For the nine months ended September 30, 2024, general and administrative costs were $2,267,890, which consisted of the fair value of vested stock options issued to directors and officers of $340,445 (including quarterly director and board committee fees of $55,000), patent and licensing legal and filing fees and costs of $192,238, other consulting and professional fees of $481,865, insurance expense of $370,167, officer compensation and related costs of $578,034, director fees paid in cash of $38,819, licensing and royalties of $68,106, shareholder reporting costs of $15,690, listing fees of $37,125, filing fees of $21,917, investor relations of $48,191, rent of $13,099, conference fees of $14,475, travel of $9,725, taxes and licenses of $30,869, and other operating costs of $7,125.
General and administrative costs increased by $812,412 or 35.8%, in 2025 as compared to 2024, primarily as a result of increases in the fair value of vested stock options issued to directors and officers of $803,903 ((including quarterly director and board committee fees of $55,000, the acceleration of the vesting of stock options held by Bas van der Baan of $167,460 as a result of the amendment of his employment contract on June 16, 2025, the vested portion of stock options granted to Geordan Pursglove, the Company's CEO, on July 3, 2025 of $546,499, the vested portion of stock options granted to Peter Stazzone, the Company's CFO, on September 1, 2025 of $55,732, and the vested portion of stock options granted to two new directors on August 15, 2025 of $76,010), other consulting and professional fees of $438,219 (including public relation fees of $184,711 paid to MicroCap Advisory LLC and $150,000 paid to IR Agency LLC), travel expenses of $31,029, director fees paid in cash of $27,500, shareholder reporting of $24,041, listing fees of $22,625, , offset by decreases in patent and licensing legal and filing fees and costs of $101,999, officer compensation and related costs of $117,631, licensing and royalties of $45,914, taxes and licenses of $15,700, investor relations of $12,000, director fees paid in cash of $11,319, rent of $13,099, conference fees of $14,475, and insurance expense of $177,337.
Effective August 4, 2025, the Company entered into a Market Awareness Agreement (the "Agreement") with MicroCap Advisory, LLC for a term of six months to develop a clear, impactful, and marketable corporate strategy to identify, reach and engage with potential investors. Following the initial 30 day term of the Agreement, either party may terminate it without cause by providing the other party with at least 15 days prior written notice. This corporate strategy was intended to serve as the foundation for a comprehensive investor communications program for the Company. The Agreement provided for a one-time account set-up fee of $15,000 and a cash fee of $125,000 per month over a period of six months, subject to increase, depending on news, events, or other opportunities to amplify public awareness, which will be reviewed and approved by both parties. In addition, the Agreement provided for the issuance of 48,000 shares of the Company's common stock to MicroCap Advisory, LLC. upon its signing. The Company also agreed to reimburse MicroCap Advisory, LLC for any pre-approved expenses incurred, including analyst reports and travel expenses. Effective September 5, 2025, the Company terminated this Agreement and issued 9,181 shares of common stock, valued at $44,711, under the Agreement as settlement of the original 48,000 common share obligation.
Interest Income. For the nine months ended September 30, 2025, the Company had interest income of $5,236, as compared to interest income of $6,529 for the nine months ended September 30, 2024, related to the investment of the Company's cash resources.
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.
Unrealized Gain (Loss) in Fair Value of Digital Assets, Net. For the nine months ended September 30, 2025, the Company had aa unrealized net loss from a decrease in the fair value of digital assets of $182,887.
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.
Net Loss. For the nine months ended September 30, 2025, the Company incurred a net loss of $3,465,626, as compared to a net loss of $2,968,271 for the three months ended September 30, 2024.
Series B Convertible Preferred Stock 8% Cumulative Dividend. For the nine months ended September 30, 2025, the Company recorded a Series B Convertible Preferred Stock dividend of $50,367.
Net Loss Attributable to Common Stockholders. For the nine months ended September 30, 2025, the Company incurred a net loss attributed to common stockholders of $3,515,993, as compared to a net loss attributed to common stockholders of $2,968,271 for the nine months ended September 30, 2024.
Liquidity and Capital Resources - September 30, 2025
The Company's condensed consolidated statements of cash flows as discussed herein are as follows:
| Nine Months Ended September 30, | ||||||||
| 2025 | 2024 | |||||||
| Net cash used in operating activities | $ | (1,982,720 | ) | $ | (2,565,861 | ) | ||
| Net cash used in investing activities | (2,637,360 | ) | - | |||||
| Net cash provided by financing activities | 6,469,002 | - | ||||||
| Net increase (decrease) in cash | $ | 1,848,922 | $ | (2,565,861 | ) | |||
At September 30, 2025, the Company had working capital of $4,912,254, as compared to working capital of $827,219 at December 31, 2024, reflecting a net increase in working capital of $4,085,035 for the nine months ended September 30, 2025. The increase in working capital during the nine months ended September 30, 2025 was primarily the result net proceeds of $4,178,162 from the sale of securities in a registered private placement that closed on July 2, 2025, and the net proceeds from the sale of securities in registered direct offerings of $914,228, that closed on February 13, 2025, and $1,330,812, that closed on July 8, 2025, offset by the level of continuing expenditures related to the Company's ongoing operations. At September 30, 2025, the Company had cash of $2,887,874 available to fund its operations.
Going Concern
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.
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.
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.
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.
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.
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.
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 $510,000, which are currently scheduled to be incurred through approximately December 31, 2027.
At September 30, 2025, the Company did not have any transactions, obligations or relationships that could be considered off-balance sheet arrangements.
Operating Activities. For the nine months ended September 30, 2025, operating activities utilized cash of $1,982,720, as compared to utilizing cash of $2,565,861 for the nine months ended September 30, 2024, to fund the Company's ongoing research and development activities and other operating expenses.
Investing Activities. For the nine months ended September 30, 2025, investing activities utilized cash of $2,637,360 for the purchase of digital assets, For the nine months ended September 30, 2024 the Company did not have any investing activities.
Financing Activities. For the nine months ended September 30, 2025, financing activities consisted of the gross proceeds from the sale of securities in the Company's registered direct offerings of $2,550,003, reduced by offering costs of $304,963, gross proceeds from the sale of securities in the Company's registered private placement of $5,050,000, reduced by offering costs of $871,838, and proceeds from the sale of common stock warrant of $45,800. For the nine months ended September 30, 2024, the Company had no financing activities.
Principal Commitments
Clinical Trial Agreements
At September 30, 2025, the Company's remaining financial contractual commitments pursuant to clinical trial agreements and clinical trial monitoring agreements not yet incurred, as described below, aggregated $510,000, including clinical trial agreements of $292,000 and clinical trial monitoring agreements of $218,000, which, based on current estimates, are currently scheduled to be incurred through approximately December 31, 2027. The Company's ability to conduct and fund these contractual commitments is subject to the timely availability of sufficient capital to fund such expenditures, as well as any changes in the allocation or reallocation of such funds to the Company's current or future clinical trial programs. The Company expects that the full amount of these expenditures will be incurred only if such clinical trial programs are conducted as originally designed and their respective enrollments and duration are not modified or reduced. Clinical trial programs, such as the types that the Company is engaged in, can be highly variable and can frequently involve a series of changes and modifications over time as clinical data is obtained and analyzed, and is frequently modified, suspended or terminated, in part based on receipt or lack of receipt of an indication of clinical benefit or activity, before the clinical trial endpoint is reached. Accordingly, such contractual commitments as discussed herein should be considered as estimates only based on current clinical assumptions and conditions and are typically subject to significant modifications and revisions over time.
The following is a summary of the Company's ongoing active contractual clinical trials described below as of September 30, 2025:
| Description of Clinical Trial | Institution | Start Date | Projected End Date | Planned Number of Patients in Trial | Study Objective | Clinical Update | Expected Date of Preliminary Efficacy Signal | NCT No. | Remaining Financial Contractual Commitment | |||||||||||||
| LB-100 combined with dostarlimab in ovarian clear cell carcinoma (Phase 1b/2) | MD Anderson | January 2024 | December 2027 | 21 | Determine the OS of patients with recurrent ovarian clear cell carcinoma | 20 patients entered | December 2026 | NCT06065462 | $ | -0- (1 | ) | |||||||||||
| LB-100 combined with atezolizumab in microsatellite stable metastatic colorectal cancer (Phase 1b) | Netherlands Cancer Institute (NKI) | August 2024 | December 2026 | 37 | Determine RP2D with atezolizumab | First patient entered August 2024, in total two patients entered | June 2026 | NCT06012734 | -0- (1 | ) | ||||||||||||
| LB-100 combined with doxorubicin in advanced soft tissue sarcoma (Phase 1b) | GEIS | June 2023 | Recruitment completed September 2024 | 14 | Determine MTD and RP2D | Fourteen patients entered | December 2025 | NCT05809830 | 292,000 | |||||||||||||
| Total | $ | 292,000 | ||||||||||||||||||||
| (1) | The Company has no financial contractual commitments associated with these clinical trials at September 30, 2025. |
Netherlands Cancer Institute. Effective June 10, 2024, the Company entered into a Clinical Trial Agreement with the Netherlands Cancer Institute ("NKI") (see Note 6) to conduct a Phase 1b clinical trial of the Company's protein phosphatase inhibitor, LB-100, combined with atezolizumab, a PD-L1 inhibitor, the proprietary molecule of F. Hoffman-La Roche Ltd. ("Roche"), for patients with microsatellite stable metastatic colorectal cancer. Under the agreement, the Company will provide its lead compound, LB-100, and under a separate agreement between NKI and Roche, Roche will provide atezolizumab and financial support for the clinical trial. The Company has no obligation to and will not provide any reimbursement of clinical trial costs. Pursuant to the agreement and the protocol set forth in the agreement, the clinical trial will be conducted by NKI at NKI's site in Amsterdam by principal investigator Neeltje Steeghs, MD, PhD, and NKI will be responsible for the recruitment of patients. The agreement provides for the protection of the respective intellectual property rights of each of the Company, NKI and Roche.
This Phase 1b clinical trial will evaluate safety, optimal dose and preliminary efficacy of LB-100 combined with atezolizumab for the treatment of patients with metastatic microsatellite stable colorectal cancer. Immunotherapy using monoclonal antibodies like atezolizumab can enhance the body's immune response against cancer and hinder tumor growth and spread. LB-100 has been found to improve the effectiveness of anticancer drugs in killing cancer cells by inhibiting a protein called PP2A on cell surfaces. Blocking PP2A increases stress signals in tumor cells expressing the PP2A protein. Accordingly, combining atezolizumab with LB-100 may enhance treatment efficacy for metastatic colorectal cancer, as cancer cells with heightened stress signals are more vulnerable to immunotherapy.
This study comprises a dose escalation phase and a dose expansion phase. The objective of the dose escalation phase is to determine the recommended Phase 2 dose (RP2D) of LB-100 when combined with the standard dosage of atezolizumab. The dose expansion phase will further investigate the preliminary efficacy, safety, tolerability, and pharmacokinetics/dynamics of the LB-100 and atezolizumab combination. The clinical trial opened in August 2024 with the enrollment of the first patient. A total of two patients have been enrolled to date. Patient accrual is expected to take up to 24 months, with a maximum of 37 patients with advanced colorectal cancer to be enrolled in this study.
The principal investigator of the colorectal study testing LB-100 in combination with atezolizumab is currently investigating two Serious Adverse Events ("SAEs") observed in the clinical trial. The Investigational Review Board (IRB) of NKI has requested additional information with respect to these SAEs and the study has been paused for enrollment until the IRB's questions have been satisfactorily addressed (see "Specific Risks Associated with the Company's Business Activities - Serious Adverse Events" below for additional information).
The Company has no financial contractual commitment associated with this clinical trial.
City of Hope. Effective January 18, 2021, the Company executed a Clinical Research Support Agreement (the "Agreement") with the City of Hope National Medical Center, an NCI-designated comprehensive cancer center, and City of Hope Medical Foundation (collectively, "City of Hope"), to carry out a Phase 1b clinical trial of LB-100, the Company's first-in-class protein phosphatase inhibitor, combined with an FDA-approved standard regimen for treatment of untreated extensive-stage disease small cell lung cancer ("ED-SCLC"). LB-100 was given in combination with carboplatin, etoposide and atezolizumab, an FDA-approved standard of care regimen, to previously untreated ED-SCLC patients. The LB-100 dose was to be escalated with the standard fixed doses of the 3-drug regimen to reach a recommended Phase 2 dose ("RP2D"). Patient entry was to be expanded so that a total of 12 patients would be evaluable at the RP2D to determine the safety of the LB-100 combination and to look for potential therapeutic activity as assessed by objective response rate, duration of overall response, progression-free survival, and overall survival.
The clinical trial was initiated on March 9, 2021, with patient accrual expected to take approximately two years to complete. Because patient accrual was slower than expected, effective March 6, 2023, the Company and City of Hope added the Sarah Cannon Research Institute ("SCRI"), Nashville, Tennessee, to the ongoing Phase 1b clinical trial. The Company and City of Hope continued efforts to increase patient accrual by adding additional sites and by modifying the protocol to increase the number of patients eligible for the clinical trial. The impact of these efforts to increase patient accrual and to decrease time to completion was evaluated in subsequent quarters.
After evaluating patient accrual through June 30, 2024, the Company and City of Hope agreed to close the clinical trial. Pursuant to the terms of the Agreement, the Company provided notice to City of Hope of the Company's intent to terminate the Agreement effective as of July 8, 2024. Upon closure, the Company incurred a prorated charge of $207,004 for the cost of patients enrolled to date, which is included in accounts payable and accrued expenses at September 30, 2025 and December 31, 2024.
During the three months ended September 30, 2025 and 2024, the Company did not incur any costs pursuant to this Agreement. During the nine months ended September 30, 2025 and 2024, the Company incurred costs of $0 and $78,015, respectively, pursuant to this Agreement. As of September 30, 2025, total costs of $732,532 had been incurred pursuant to this Agreement.
GEIS. Effective July 31, 2019, the Company entered into a Collaboration Agreement for an Investigator-Initiated Clinical Trial with the Spanish Sarcoma Group (Grupo Español de Investigación en Sarcomas or "GEIS"), Madrid, Spain, to carry out a study entitled "Randomized phase I/II trial of LB-100 plus doxorubicin vs. doxorubicin alone in first line of advanced soft tissue sarcoma". The purpose of this clinical trial is to obtain information with respect to the efficacy and safety of LB-100 combined with doxorubicin in soft tissue sarcomas. Doxorubicin is the global standard for initial treatment of advanced soft tissue sarcomas ("ASTS"). Doxorubicin alone has been the mainstay of first line treatment of ASTS for over 40 years, with little improvement in survival from adding cytotoxic compounds to or substituting other cytotoxic compounds for doxorubicin. In animal models, LB-100 has consistently enhanced the anti-tumor activity of doxorubicin without apparent increases in toxicity.
GEIS has a network of referral centers in Spain and across Europe that have an impressive track record of efficiently conducting innovative studies in ASTS. The Company agreed to provide GEIS with a supply of LB-100 to be utilized in the conduct of this clinical trial, as well as to provide funding for the clinical trial. The goal is to enter approximately 150 to 170 patients in this clinical trial over a period of two to four years. The Phase 1 portion of the study began in the quarter ended June 30, 2023 to determine the recommended Phase 2 dose of the combination of doxorubicin and LB-100. As advanced sarcoma is a very aggressive disease, the design of the Phase 2 portion of the study assumes a median progression-free survival ("PFS"), no evidence of disease progression or death from any cause, of 4.5 months in the doxorubicin arm and an alternative median PFS of 7.5 months in the doxorubicin plus LB-100 arm to demonstrate a statistically significant decrease in relative risk of progression or death by adding LB-100. There is a planned interim analysis of the primary endpoint when approximately 50% of the 102 events required for final analysis is reached.
The Company had previously expected that this clinical trial would commence during the quarter ended June 30, 2020. However, during July 2020, the Spanish regulatory authority advised the Company that although it had approved the scientific and ethical basis of the protocol, it required that the Company manufacture new inventory of LB-100 under current Spanish pharmaceutical manufacturing standards. These standards were adopted subsequent to the production of the Company's existing LB-100 inventory.
In order to manufacture a new inventory supply of LB-100 for the GEIS clinical trial, the Company engaged a number of vendors to carry out the multiple tasks needed to make and gain approval of a new clinical product for investigational study in Spain. These tasks included the synthesis under good manufacturing practice (GMP) of the active pharmaceutical ingredient (API), with documentation of each of the steps involved by an independent auditor. The API was then transferred to a vendor that prepares the clinical drug product, also under GMP conditions documented by an independent auditor. The clinical drug product was then sent to a vendor to test for purity and sterility, provide appropriate labels, store the drug, and distribute the drug to the clinical centers for use in the clinical trials. A formal application documenting all steps taken to prepare the clinical drug product for clinical use was submitted to the appropriate regulatory authorities for review and approval before being used in a clinical trial.
As of September 30, 2025, this program to provide new inventory of the clinical drug product for the Spanish Sarcoma Group study, and potentially for subsequent multiple trials within the European Union, had cost approximately $1,144,000.
On October 13, 2022, the Company announced that the Spanish Agency for Medicines and Health Products (Agencia Española de Medicamentos y Productos Sanitarios or "AEMPS") had authorized a Phase 1b/randomized Phase 2 study of LB-100, the Company's lead clinical compound, plus doxorubicin, versus doxorubicin alone, the global standard for initial treatment of ASTS. Consequently, this clinical trial commenced during the quarter ended June 30, 2023 and is expected to be completed and a report prepared by December 31, 2026. In April 2023, GEIS completed its first site initiation visit in preparation for the clinical trial at Fundación Jiménez Díaz University Hospital (Madrid). Up to 170 patents will be entered into the clinical trial. The recruitment for the Phase 1b portion of the protocol was extended with two patients and was completed during the quarter ended September 30, 2024. The Company expects to have data on toxicity and preliminary efficacy from this portion of the clinical trial during the quarter ending December 31, 2025.
Given the focus on the combination of LB-100 with immunotherapy in ovarian clear cell carcinoma and colorectal cancer and the availability of capital resources, the Company entered into Amendment No. 1 to the Collaboration Agreement effective March 11, 2025 that relieved the Company of the financial obligation to support the randomized Phase 2 portion of the clinical trial contemplated in the Collaboration Agreement of approximately $3,095,000. As a result, it is uncertain as to whether the Phase 2 portion of this clinical trial will proceed.
The Company's agreement with GEIS provided for various payments based on achieving specific milestones over the term of the agreement. During the three months ended September 30, 2025 and 2024, the Company did not incur any costs pursuant to this agreement. During the nine months ended September 30, 2025 and 2024, the Company did not incur any costs pursuant to this agreement. Through September 30, 2025, the Company has incurred charges of $685,107 for work done under this agreement through the fourth milestone.
The Company's aggregate commitment pursuant to this agreement, less amounts previously paid to date, totaled approximately $292,000 for the Phase 1b portion of this clinical trial as of September 30, 2025, which is currently scheduled to be incurred through December 31, 2025. As the work is being conducted in Europe and is paid for in Euros, final costs are subject to foreign currency fluctuations between the United States Dollar and the Euro. Such fluctuations are recorded in the consolidated statements of operations as foreign currency gain or loss, as appropriate, and have not been significant.
MD Anderson Cancer Center Clinical Trial. On September 20, 2023, the Company announced an investigator-initiated Phase 1b/2 collaborative clinical trial to assess whether adding LB-100 to a human programmed death receptor-1 ("PD-1") blocking antibody of GSK plc ("GSK"), dostarlimab-gxly, may enhance the effectiveness of immunotherapy in the treatment of ovarian clear cell carcinoma ("OCCC"). The study objective is to determine the overall survival ("OS") of patients with OCCC. The clinical trial is being sponsored by The University of Texas MD Anderson Cancer Center ("MD Anderson") and is being conducted at The University of Texas - MD Anderson Cancer Center. The Company is providing LB-100 and GSK is providing dostarlimab-gxly and financial support for the clinical trial. On January 29, 2024, the Company announced the entry of the first patient into this clinical trial. The Company currently expects that this clinical trial will be completed by December 31, 2027.
On February 25, 2025, the Company announced that it has 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. Patient recruitment is underway, and the first patient has been dosed.
Clinical Trial Monitoring Agreements
MD Anderson Cancer Center Clinical Trial. On May 15, 2024, the Company signed a letter of intent with Theradex to monitor the MD Andersen investigator-initiated Phase 1b/2 collaborative clinical trial to assess whether adding LB-100 to a human programmed death receptor-1 ("PD-1") blocking antibody of GSK plc ("GSK"), dostarlimab-gxly, may enhance the effectiveness of immunotherapy in the treatment of ovarian clear cell carcinoma ("OCCC"). On August 19, 2024, the Company signed a work order agreement with Theradex to monitor the MD Anderson clinical trial. The study oversight is expected to be completed by January 31, 2027.
Costs under this letter of intent and related work order agreement are estimated to be approximately $95,000. During the three months ended September 30, 2025 and 2024, the Company incurred costs of $4,942 and $12,610 pursuant to this letter of intent and subsequent work order. During the nine months ended September 30, 2025 and 2024, the Company incurred costs of $16,834 and $20,838 pursuant to this letter of intent and subsequent work order. As of September 30, 2025, total costs of $43,597 have been incurred pursuant to this letter of intent and subsequent work order.
The Company's aggregate commitment pursuant to this letter of intent, less amounts previously paid to date, totaled approximately $53,000 as of September 30, 2025, which is expected to be incurred through December 31, 2027.
City of Hope. On February 5, 2021, the Company signed a new work order agreement with Theradex to monitor the City of Hope investigator-initiated clinical trial in small cell lung cancer in accordance with FDA requirements for oversight by the sponsoring party. Costs under this work order agreement were estimated to be approximately $335,000. During the three months ended September 30, 2025 and 2024, the Company incurred costs of $0 and $1,603, respectively, pursuant to this work order. During the nine months ended September 30, 2025 and 2024, the Company incurred costs of $0 and $10,603, respectively, pursuant to this work order. As of September 30, 2025, total costs of $87,823 had been incurred pursuant to this work order agreement.
As a result of the closure of the Agreement with City of Hope effective July 8, 2024 (see "Clinical Trial Agreements - City of Hope" above), the work order agreement with Theradex to monitor this clinical trial was concurrently terminated, although nominal oversight trailing costs subsequent to July 8, 2024 are expected to be incurred relating to the closure of this study.
GEIS. On June 22, 2023, the Company finalized a work order agreement with Theradex, to monitor the GEIS investigator-initiated clinical Phase I/II randomized trial of LB-100 plus doxorubicin vs. doxorubicin alone in first line of advanced soft tissue sarcoma. The study oversight is expected to be completed by December 31, 2026.
Costs under this work order agreement are estimated to be approximately $153,000, with such payments expected to be allocated approximately 72% to Theradex for services and approximately 28% for payments for pass-through software costs. During the three months ended September 30, 2025 and 2024, the Company incurred costs of $3,981 and $13,475, respectively, pursuant to this work order. During the nine months ended September 30, 2025 and 2024, the Company incurred costs of $11,603 and $26,207, respectively, pursuant to this work order. As of September 30, 2025, total costs of $61,058 have been incurred pursuant to this work order agreement.
The Company's aggregate commitment pursuant to this clinical trial monitoring agreement, less amounts previously paid to date, totaled approximately $91,000 as of September 30, 2025, which is expected to be incurred through December 31, 2026.
Netherlands Cancer Institute. On August 27, 2024, the Company finalized a work order agreement with Theradex, to monitor the NKI Phase 1b clinical trial of LB-100 combined with atezolizumab, a PD-L1 inhibitor, for patients with microsatellite stable metastatic colorectal cancer. The study oversight was expected to be completed by May 31, 2027.
Costs under this work order agreement were estimated to be approximately $106,380, with such payments expected to be allocated approximately 47% to Theradex for services and approximately 53% for payments for pass-through software costs. During three months ended September 30, 2025 and 2024, the Company incurred costs of $4,500 and $14,900, respectively, pursuant to this work order. During the nine months ended September 30, 2025 and 2024, the Company incurred costs of $13,500 and $14,900, respectively, pursuant to this work order. As of September 30, 2025, total costs of $33,691 have been incurred pursuant to this work order agreement.
The Company's aggregate commitment pursuant to this clinical trial monitoring agreement, less amounts previously paid to date, totaled approximately $74,000 as of September 30, 2025, which was expected to be incurred through May 31, 2027.
Patent and License Agreements
National Institute of Health. Effective February 23, 2024, the Company entered into a Patent License Agreement (the "License Agreement") with the National Institute of Neurological Disorders and Stroke ("NINDS") and the National Cancer Institute ("NCI"), each an institute or center of the National Institute of Health ("NIH"). Pursuant to the License Agreement, the Company has licensed on an exclusive basis the NIH's intellectual property rights claimed for a Cooperative Research and Development Agreement ("CRADA") subject invention co-developed with the Company, and the licensed field of use, which focuses on promoting anti-cancer activity alone, or in combination with standard anti-cancer drugs. The scope of this clinical research extends to checkpoint inhibitors, immunotherapy, and radiation for the treatment of cancer. The License Agreement is effective, and shall extend, on a licensed product, licensed process, and country basis, until the expiration of the last-to-expire valid claim of the jointly owned licensed patent rights in each such country in the licensed territory, estimated at twenty years, unless sooner terminated.
The License Agreement contemplates that the Company will seek to work with pharmaceutical companies and clinical trial sites (including comprehensive cancer centers) to initiate clinical trials within timeframes that will meet certain benchmarks. Data from the clinical trials will be the subject of various regulatory filings for marketing approval in applicable countries in the licensed territories. Subject to the receipt of marketing approval, the Company would be expected to commercialize the licensed products in markets where regulatory approval has been obtained.
The Company is obligated to pay the NIH a non-creditable, non-refundable license issue royalty of $50,000 and a first minimum annual royalty within sixty days from the effective date of the Agreement. The first minimum annual royalty of $25,643 was prorated from the effective date of the License Agreement to the next subsequent January 1. Thereafter, the minimum annual royalty of $30,000 is due each January 1 and may be credited against any earned royalties due for sales made in that year. The license issue royalty of $50,000 and the first minimum annual royalty of $25,643 were paid in April 2024. The second minimum annual royalty for 2025 of $30,000 was paid in December 2024 and was included in other prepaid expenses in the consolidated balance sheet at December 31, 2024.
The Company is obligated to pay the NIH, on a country-by-country basis, earned royalties of 2% on net sales of each royalty-bearing product and process, subject to reduction by 50% under certain circumstances relating to royalties paid by the Company to third parties, but not less than 1%. The Company's obligation to pay earned royalties under the License Agreement commences on the date of the first commercial sale of a royalty-bearing product or process and expires on the date on which the last valid claim of the licensed product or licensed process expires in such country.
The Company is obligated to pay the NIH benchmark royalties, on a one-time basis, within sixty days from the first achievement of each such benchmark. The License Agreement defines four such benchmarks, which the Company is required to pursue based on "commercially reasonable efforts" as defined in the License Agreement, with deadlines of October 1, 2024, 2027, 2029 and 2031, each with a different specified benchmark payment amount payable within thirty days of achieving such benchmark. The October 1, 2024 benchmark of $100,000 was defined as the dosing of the first patient with a licensed product in a Phase 2 clinical study of such licensed product in the licensed fields of use. The Company had not commenced a Phase 2 clinical study as of June 30, 2025. The total of all such benchmark payments is $1,225,000.
The Company is obligated to provide annual reports to the NIH on its progress toward the development and commercialization of products under the licensed patents. These reports, due within sixty days following the end of each calendar year, must include updates on research and development activities, regulatory submissions, manufacturing efforts, sublicensing, and sales initiatives. If any deviations from the established commercial development plan or agreed-upon benchmarks occur, the Company is obligated to provide explanation and may amend the commercial development plan and the benchmarks, which, subject to certain conditions, the NIH shall not unreasonably withhold, condition, or delay approval of any request of the Company to amend the commercial development plan and/or the benchmarks and to extend the time periods of the benchmarks.
The Company is obligated to pay the NIH sublicensing royalties of 5% on sublicensing revenue received for granting each sublicense within sixty days of receipt of such sublicensing revenue.
During the three months ended September 30, 2025 and 2024, the Company incurred costs of $7,397 and $7,537, respectively, in connection with its obligations under the License Agreement. During the nine months ended June 30, 2025 and 2024, the Company incurred costs of $22,191 and $68,106, respectively, in connection with its obligations under the License Agreement. Such costs when incurred have been included in general and administrative costs in the Company's consolidated statement of operations. As of September 30, 2025, total costs of $97,835 have been incurred pursuant to this agreement. The Company's aggregate commitment pursuant to this agreement, less amounts previously paid to date, totaled approximately $1,765,000 as of September 30, 2025, which is expected to be incurred over approximately the next twenty years.
Other Significant Agreements and Contracts
NDA Consulting Corp. On December 24, 2013, the Company entered into a consulting agreement with NDA Consulting Corp. for consultation and advice in the field of oncology research and drug development. As part of the consulting agreement, NDA also agreed to have its president, Dr. Daniel D. Von Hoff, M.D., serve on the Company's Scientific Advisory Committee during the term of such consulting agreement. The term of the consulting agreement was for one year and provided for a quarterly cash fee of $4,000. The consulting agreement had been automatically renewed for additional one-year terms on its anniversary date, most recently on December 24, 2023, but was subsequently terminated by mutual agreement effective September 30, 2024. Consulting and advisory fees charged to operations pursuant to this consulting agreement were $4,000 and $12,000 for the three months and nine months ended September 30, 2024, respectively.
BioPharmaWorks. Effective September 14, 2015, the Company entered into a Collaboration Agreement with BioPharmaWorks, pursuant to which the Company engaged BioPharmaWorks to perform certain services for the Company. Those services included, among other things, assisting the Company to commercialize its products and strengthen its patent portfolio; identifying large pharmaceutical companies with a potential interest in the Company's product pipeline; assisting in preparing technical presentations concerning the Company's products; consultation in drug discovery and development; and identifying providers and overseeing tasks relating to clinical development of new compounds.
BioPharmaWorks was founded in 2015 by former Pfizer scientists with extensive multi-disciplinary research and development and drug development experience. The Collaboration Agreement was for an initial term of two years and automatically renews for subsequent annual periods unless terminated by a party not less than 60 days prior to the expiration of the applicable period. In connection with the Collaboration Agreement, the Company agreed to pay BioPharmaWorks a monthly fee of $10,000, subject to the right of the Company to pay a negotiated hourly rate in lieu of the monthly fee. Effective March 1, 2024, the compensation payable under the Collaboration Agreement was converted to an hourly rate structure.
The Company recorded charges to operations pursuant to this Collaboration Agreement of $13,600 and $8,000 during the three months ended September 30, 2025 and 2024, respectively, which were included in research and development costs in the consolidated statements of operations. The Company recorded charges to operations pursuant to this Collaboration Agreement of $38,400 and $35,200 during the nine months ended September 30, 2025 and 2024, respectively, which were included in research and development costs in the consolidated statements of operations.
Netherlands Cancer Institute. On October 8, 2021, the Company entered into a Development Collaboration Agreement with the Netherlands Cancer Institute, Amsterdam ("NKI") (see Note 5), one of the world's leading comprehensive cancer centers, and Oncode Institute, Utrecht, a major independent cancer research center, for a term of three years. The Development Collaboration Agreement was subsequently modified by Amendment No. 1 thereto.
The Development Collaboration Agreement is a preclinical study intended to identify the most promising drugs to be combined with LB-100, and potentially LB-100 analogues, to be used to treat a range of cancers, as well as to identify the specific molecular mechanisms underlying the identified combinations. The Company agreed to fund the preclinical study, at an approximate cost of 391,000 Euros and provide a sufficient supply of LB-100 to conduct the preclinical study.
On October 3, 2023, the Company entered into Amendment No. 2 to the Development Collaboration Agreement with NKI, which provides for additional research activities, extends the termination date of the Development Collaboration Agreement by two years to October 8, 2026, and added 500,000 Euros to the operating budget being funded by the Company.
On October 4, 2024, the Company entered into Amendment No. 3 to the Development Collaboration Agreement with NKI, which suspended Amendment No. 2 and provided for a new study term of one year commencing upon the dosing of the first patient in the trial at a project cost of 100,000 Euros.
During the three months ended September 30, 2025 and 2024, the Company incurred charges of $0 and $76,278, respectively, with respect to this agreement, which amounts are included in research and development costs in the Company's consolidated statements of operations. During the nine months ended September 30, 2025 and 2024, the Company incurred charges of $0 and $210,362, respectively, with respect to this agreement, which amounts are included in research and development costs in the Company's consolidated statements of operations. As of September 30, 2025, total costs of $695,918 have been incurred pursuant to this agreement.
MRI Global. As amended, the Company has contracted with MRI Global for stability analysis, storage and distribution of LB-100 for clinical trials in the United States. During the three months ended September 30, 2025 and 2024, the Company incurred costs of $7,200 and $9,062, respectively, pursuant to this contract. During the nine months ended September 30, 2025 and 2024, the Company incurred costs of $42,057 and $18,932, respectively, pursuant to this contract. As of September 30, 2025, total costs of $382,579 have been incurred pursuant to this contract.
The Company's aggregate commitment pursuant to this contract, less amounts previously paid to date, totaled approximately $84,000 as of September 30, 2025.
Specific Risks Associated with the Company's Business Activities
Serious Adverse Events
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.
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.
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.
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.
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.
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.
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.
Other Business Risks
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.
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.
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.
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.
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.
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.
The Company is continuing to monitor these matters and will adjust its current business and financing plans as more information becomes available.
Consideration of Strategic Alternatives
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.
The Company will continue to evaluate various alternatives to be able to obtain the capital required to fund its operations and business development activities, and to maintain its listing on the Nasdaq Capital Market, including merger or acquisition opportunities (including reverse mergers and acquisitions) and funding transactions which could result in a change in control of the Company. There can be no assurances that the evaluation process will result in the identification of an appropriate transaction, the negotiation and execution of a definitive agreement to effect such a transaction, or that any such transaction will ultimately be approved by the Company's stockholders and then be consummated. Even if such a strategic transaction is consummated, there can be no assurances that it would enhance stockholder value, and it may result in substantial dilution to existing stockholders. Any potential transaction would be dependent on a number of factors that may be outside of the control of the Company, including, among other things, market conditions, industry trends, the interest of third parties in a potential transaction with the Company, and the availability of appropriate financing for such a transaction.
Trends, Events and Uncertainties
Research and development of new pharmaceutical compounds by its nature is unpredictable. Although the Company undertakes research and development efforts with commercially reasonable diligence, there can be no assurance that the Company's cash position will be sufficient to enable it to develop any pharmaceutical compound to the extent needed to create future sales to sustain operations as contemplated herein.
There can be no assurance that the Company's pharmaceutical compound will obtain the regulatory approvals and market acceptance to achieve sustainable revenues sufficient to support the Company's operations. Even if the Company is able to generate revenues, there can be no assurance that the Company will be able to achieve operating profitability or positive operating cash flows. There can be no assurance that the Company will be able to secure additional financing, to the extent required, on acceptable terms or at all. If cash resources are insufficient to satisfy the Company's ongoing cash requirements, the Company would be required to reduce or discontinue its research and development programs, or attempt to 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 discontinue operations entirely.
Other than as discussed above, the Company is not currently aware of any trends, events or uncertainties that are likely to have a material effect on its financial condition in the near term, although it is possible that new trends or events may develop in the future that could have a material effect on the Company's financial condition.
Lixte Biotechnology Holdings Inc. published this content on November 12, 2025, and is solely responsible for the information contained herein. Distributed via Edgar on November 12, 2025 at 21:27 UTC. If you believe the information included in the content is inaccurate or outdated and requires editing or removal, please contact us at [email protected]