LIXTE BIOTECHNOLOGY HOLDINGS, INC.
For the period ended Dec 31, 2025. Filed Mar 31, 2026.
View on SEC.govAbout this filing
A company's yearly report to the SEC, with audited financial statements. It is the fullest account a company gives of its business, its finances and the risks it sees.
FY2025 · Filed Mar 31, 2026
What changed in Management’s Discussion and Analysis?
Read the current filingPrevious report: 10-K
Period ended 2024-12-31; filed 2025-03-24.
0001641172-25-000208
Item 7. MANAGEMENT’S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS OF OPERATIONSCurrent report: 10-K
Period ended 2025-12-31; filed 2026-03-31.
0001493152-26-014052
Item 7. MANAGEMENT’S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS OF OPERATIONSThe baseline is this issuer’s latest earlier reporting period of the same form that was filed before the current report. A previous 10-Q is a different quarter, not a year-over-year comparison. Amendments are excluded.
Compared 188 previous paragraphs and 174 current paragraphs.
99 unchanged; 42 reworded; 33 added; 44 removed; 3 previous and 0 current paragraphs rearranged.
Tables are not compared: 4 previous and 3 current tables excluded. Dates, whitespace, punctuation and numbering changes are ignored; changes to financial figures remain significant.
A changed paragraph is not evidence that risk increased or decreased. An unchanged paragraph does not establish that risk stayed the same.
Added paragraphs (33)
Current report
Liora’s proprietary technology, known as LiGHT System (Linac for Image Guided Hadron Therapy), has significant advantages over currently available technologies for treating tumors with proton therapy. Liora is an excellent complement to the pharmaceutical side of the Company’s business and ongoing clinical trials with LB-100 for Ovarian Clear Cell Carcinoma and Metastatic Colon Cancer, The Company’s strategy for the LiGHT system is to position it as a functional prototype asset (rather than a turnkey clinical system), valued primarily for its intellectual property, accelerator hardware configuration, and accumulated engineering work, without immediate clinical operability. It will be saleable as a functional unlicensed prototype to be copied and licensed at locations closer to large patient populations.
Current report
For the year ended December 31, 2025, the Company incurred a net loss of $6,009,520 and used cash in operations of $3,070,618. As of December 31, 2025, the Company had cash of $5,106,872 available to fund its operations. The Company has not generated recurring revenues since inception and has incurred negative operating cash flows as it advances its clinical development programs.
Current report
The Company is currently engaged in early-stage clinical trials for its lead product candidate, LB-100. These activities require substantial research, development, regulatory, and clinical expenditures, and the Company does not expect to generate sustainable operating revenues for several years, if ever. At March 31, 2026, the Company’s remaining contractual commitments pursuant to clinical trial agreements and clinical trial monitoring agreements aggregated approximately $496,000, which are expected to be incurred through December 31, 2027.
Current report
In addition, through the acquisition of Liora Technologies Europe Ltd. in November 2025, the Company assumed responsibility for the non-clinical LiGHT proton therapy prototype located at the Daresbury Laboratory in the United Kingdom. The Company expects to incur approximately $2 million over the next twenty-four months to recommission and update the system, together with annual lease obligations of approximately $787,278 under an operating lease with the United Kingdom Research and Innovation. Liora currently has no revenues, and the Company will require additional capital to fund these activities.
Current report
Management is actively evaluating and pursuing additional financing alternatives, including equity and debt financings and potential strategic transactions. However, there can be no assurance that additional funding will be available on acceptable terms, in sufficient amounts, or at all. If the Company is unable to obtain the necessary funding, it may be required to delay, scale back, or eliminate its clinical development programs; curtail expenditures related to the LiGHT system; or pursue strategic alternatives, including potential asset sales or the cessation of operations.
Current report
As a result, management has concluded, and our independent registered public accounting firm has agreed with our conclusion, that there is a substantial doubt regarding the Company’s ability to continue as a going concern for a period of at least 12 months beyond the filing of this Annual Report on Form 10-K. As a result, the report of our independent registered public accounting firm on our financial statements for the year ended December 31, 2025, includes an explanatory paragraph regarding the existence of substantial doubt about our ability to continue as a going concern.
Current report
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.
Current report
Following an April 3, 2025 hearing, the Panel granted the Company a further extension through July 3, 2025 to regain compliance.
Current report
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.
Current report
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.
Current report
Asset Acquisitions
Current report
The Company assesses whether an acquisition is a business combination or an asset acquisition. If substantially all of the gross assets acquired are concentrated in a single asset or group of similar assets, then the acquisition is accounted for as an asset acquisition, where the purchase consideration is allocated on a relative fair value basis to the assets acquired. An asset acquisition does not result in the recognition of goodwill and transaction costs are capitalized as part of the cost of the asset or group of assets acquired. The Company uses its best estimates and assumptions to assign fair value to the tangible and intangible assets acquired and liabilities assumed at the acquisition date. The acquisitions costs are allocated to the assets acquired on a relative fair value basis.
Current report
Digital Assets
Current report
The Company periodically holds certain digital assets, consisting of Bitcoin and Ethereum cryptocurrencies. Digital assets are initially recorded at cost and subsequently measured at fair value as of each reporting period. The Company determines the fair value of its digital assets in accordance with FASB ASC 820, Fair Value Measurement, based on quoted prices on the active exchange(s) that it has determined is the principal market for Bitcoin and Ethereum (Level 1). Changes in fair value are included in unrealized gain (loss) on digital assets in other income (expense) in the Company’s consolidated statements of operations. 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 tracks its cost basis of digital assets in accordance with the first-in-first-out method of accounting. 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.
Current report
Property and Equipment
Current report
The Company property and equipment consists of Liora’s Light machine. Property and equipment are recorded at cost. The Light machine requires recommissioning and updates and is not yet ready for its intended use. Accordingly, it is treated as an asset under construction, and depreciation will not begin until the asset is placed into service.
Current report
Long – Lived Assets
Current report
Long-lived assets, which include property, plant and equipment and operating lease right-of-use assets, are reviewed for impairment whenever events or changes in circumstances indicate the carrying amount of an asset may not be recoverable.
Current report
Recoverability of long-lived assets to be held and used is measured by comparing the carrying amount of an asset to the estimated undiscounted future cash flows expected to be generated by the asset. If the carrying amount of an asset exceeds its estimated undiscounted future cash flows, an impairment charge is recognized by the amount by which the carrying amount of the asset exceeds the fair value of the assets. Fair value is generally determined using the asset’s expected future discounted cash flows or market value, if readily determinable.
Current report
The Company reviews long-lived assets for impairment whenever events or changes in circumstances indicate that the asset’s carrying amount may not be recoverable. In conducting its long-lived asset impairment analyses, the Company groups assets and liabilities at the lowest level for which identifiable cash flows are largely independent of the cash flows of other assets and liabilities and evaluates the asset group against the sum of the undiscounted future cash flows. If the undiscounted cash flows do not indicate the carrying amount of the asset is recoverable, an impairment charge is measured as the amount by which the carrying amount of the asset group asset group exceeds its fair value based on discounted cash flow analysis or appraisals. There was no impairment of long-lived assets for the periods ended December 31, 2025 and 2024.
Current report
The Company is the majority shareholder of Liora Technologies Europe Ltd., which is pioneering the development of electronically controlled proton therapy systems for treating tumors in various types of cancers. Liora’s proprietary technology, known as LiGHT System (Linac for Image Guided Hadron Therapy), has significant advantages over currently available technologies for treating tumors with proton therapy. Liora is an excellent complement to the pharmaceutical side of the Company’s business and ongoing clinical trials with LB-100 for Ovarian Clear Cell Carcinoma and Metastatic Colon Cancer,
Current report
LB-100
Current report
LIORA TECHNOLOGIE EUROPE LTD..
Current report
The Company’s strategy for the LiGHT system is to position it as a functional prototype asset (rather than a turnkey clinical system), valued primarily for its intellectual property, accelerator hardware configuration, and accumulated engineering work, without immediate clinical operability. It will be saleable as a functional unlicensed prototype to be copied and licensed at locations closer to large patient populations.
Current report
Years Ended December 31, 2025 and 2024
Current report
Realized loss on digital assets. During the year ended December 31, 2025, the Company recorded a realized loss related to the disposal of certain digital assets (BTC and ETH) that were transferred to Orbit as part of the consideration for the LiGHT equipment acquired in the Liora transaction. This loss reflects the difference between the carrying value of the digital assets and their fair value at the time of transfer.
Current report
As a result, management has concluded, and our independent registered public accounting firm has agreed with our conclusion, that there is a substantial doubt regarding the Company’s ability to continue as a going concern for a period of at least 12 months beyond the filing of this Annual Report on Form 10-K. As a result, the report of our independent registered public accounting firm on our financial statements for the year ended December 31, 2025, includes an explanatory paragraph regarding the existence of substantial doubt about our ability to continue as a going concern.
Current report
For the year ended December 31, 2025, the Company incurred a net loss of $6,009,520 and used cash in operations of $3,070,618. As of December 31, 2025, the Company had cash of $5,106,872 available to fund its operations. The Company has not generated recurring revenues since inception and has incurred negative operating cash flows as it advances its clinical development programs.
Current report
The Company is currently engaged in early-stage clinical trials for its lead product candidate, LB-100. These activities require substantial research, development, regulatory, and clinical expenditures, and the Company does not expect to generate sustainable operating revenues for several years, if ever. At March 31, 2026, the Company’s remaining contractual commitments pursuant to clinical trial agreements and clinical trial monitoring agreements aggregated approximately $496,000, which are expected to be incurred through December 31, 2027.
Current report
In addition, through the acquisition of Liora Technologies Europe Ltd. in November 2025, the Company assumed responsibility for the non-clinical LiGHT proton therapy prototype located at the Daresbury Laboratory in the United Kingdom. The Company expects to incur approximately $2 million over the next twenty-four months to recommission and update the system, together with annual lease obligations of approximately $787,278 under an operating lease with the United Kingdom Research and Innovation. Liora currently has no revenues, and the Company will require additional capital to fund these activities.
Current report
Management is actively evaluating and pursuing additional financing alternatives, including equity and debt financings and potential strategic transactions. However, there can be no assurance that additional funding will be available on acceptable terms, in sufficient amounts, or at all. If the Company is unable to obtain the necessary funding, it may be required to delay, scale back, or eliminate its clinical development programs; curtail expenditures related to the LiGHT system; or pursue strategic alternatives, including potential asset sales or the cessation of operations.
Current report
(1) The Company has no financial contractual commitment associated with this clinical trial at December 31, 2025.
Current report
On December 23, 2025 we announced that we are going to expand the enrollment of the trial from 21 to 42 patients in collaboration with GSK, MD Anderson and Northwestern University. We completed the enrollment of the first 21 patients in Q4, 2025 and expect patient 22 to be enrolled in Q1 2026.
Removed paragraphs (44)
Previous report
Going Concern
Previous report
For the year ended December 31, 2024, the Company recorded a net loss of $3,585,965 and used cash in operations of $3,164,536. At December 31, 2024, the Company had cash of $1,038,952 available to fund its operations. Subsequently, the Company completed a securities offering that generated gross proceeds of $1,050,003 during February 2025 before deducting the placement agent’s fees and related offering expenses.
Previous report
Because the Company is currently engaged in various early-stage clinical trials, it is expected that it will take a significant amount of time and resources to develop any product or intellectual property capable of generating sustainable revenues. Accordingly, the Company’s business is unlikely to generate any sustainable operating revenues in the next several years and may never do so. Even if the Company is able to generate revenues through licensing its technology, product sales or other commercial activities, there can be no assurance that the Company will be able to achieve and maintain positive earnings and operating cash flows. At March 14, 2025, the Company’s remaining financial contractual commitments pursuant to clinical trial agreements and clinical trial monitoring agreements not yet incurred aggregated approximately $526,000, which are currently scheduled to be incurred through approximately December 31, 2027.
Previous report
Based on current operating plans, the Company estimates that its existing cash resources at December 31, 2024, and the funds raised subsequent to December 31, 2024, will provide sufficient working capital to fund the current clinical trial program with respect to the development of the Company’s lead anti-cancer clinical compound LB-100 through approximately September 30, 2025. However, existing cash resources will not be sufficient to complete the development of and obtain regulatory approval for the Company’s product candidate, which will require that the Company raise significant additional capital. The Company estimates that it will need to raise additional capital to fund its operations by mid-2025 to be able to proactively manage its current business plan during the remainder of 2025 and during 2026. In addition, the Company’s operating plans may change as a result of many factors that are currently unknown and/or outside of the control of the Company, and additional funds may be needed sooner than planned. The Company is considering various strategies and alternatives to obtain the required additional capital. However, as market conditions present uncertainty as to the Company’s ability to secure additional funds, there can be no assurance that the Company will be able to secure additional financing on acceptable terms, as and when necessary, to continue to conduct operations.
Previous report
If cash resources are insufficient to satisfy the Company’s ongoing cash requirements, the Company would be required to scale back or discontinue its clinical trial program, as well as its licensing and patent prosecution efforts and its technology and product development efforts, or obtain funds, if available, through strategic alliances, joint ventures or other transaction structures that could require the Company to relinquish rights to and/or control of LB-100, or to curtail or discontinue operations entirely.
Previous report
Reverse Stock Split
Previous report
On June 2, 2023, the Company effected a 1-for-10 reverse split of its outstanding shares of common stock. The authorized number of shares of common stock and the par value per share were not affected by the reverse stock split. No fractional shares were issued in connection with the reverse stock split, with all fractional shares being rounded up to the next whole share. All share and per share amounts and information presented herein have been retroactively adjusted to reflect the reverse stock split for all periods presented.
Previous report
The Company timely filed an appeal and requested a Hearing before a Nasdaq Hearings Panel (the “Panel”), which has been granted. The Hearing request automatically stayed Nasdaq’s delisting of the Company’s common shares and warrants pending the Panel’s decision. Pursuant to the Nasdaq Listing Rules, the Panel has the discretion to grant the Company an additional extension through no later than August 18, 2025. At the upcoming hearing, the Company will present its plan for regaining and sustaining compliance with the Stockholders’ Equity Requirement for continued listing. However, there can be no assurances that the Hearings Panel will grant the Company an extension of time to regain compliance, or that the Company will be able to regain compliance during any extension period. During the appeal process the Company’s common shares and warrants will continue to trade on The Nasdaq Capital Market.
Previous report
The Company intends to take reasonable measures available to regain compliance under Nasdaq’s listing rules and to remain listed on Nasdaq. However, there can be no assurances that the Company will ultimately regain compliance with the Stockholders’ Equity Rule, or be able to maintain compliance with all other applicable requirements for continued listing on Nasdaq. If the Company does not regain compliance with Nasdaq’s continued listing requirements within the time period permitted by Nasdaq, then the Company’s securities will be delisted from Nasdaq.
Previous report
Concentration of Risk
Previous report
The Company periodically contracts with vendors and consultants to provide services related to the Company’s operations. Charges incurred for these services can be for a specific period (typically one year) or for a specific project or task. Costs and expenses incurred that represented 10% or more of general and administrative costs or research and development costs for the years ended December 31, 2024 and 2023 are described below.
Previous report
General and administrative costs for the years ended December 31, 2024 and 2023 include charges from legal firms and other vendors for general licensing and patent prosecution costs relating to the Company’s intellectual properties representing 8.6% and 23.3% of total general and administrative costs, respectively. General and administrative costs for the year ended December 31, 2024 also include charges from two vendors and consultants representing 15.0% and 13.1%, respectively, of total general and administrative costs. General and administrative costs for the year ended December 31, 2023 also include charges from a vendor and consultant representing 10.4% of total general and administrative costs. General and administrative costs for the years ended December 31, 2024 and 2023 also included charges for the fair value of stock options granted to directors and corporate officers representing 14.7% and 18.4%, respectively, of total general and administrative costs.
Previous report
Research and development costs for the year ended December 31, 2024 include charges from three vendors and consultants representing 39.2%, 29.0% and 15.4%, respectively, of total research and development costs. Research and development costs for the year ended December 31, 2023 include charges from three vendors and consultants representing 29.9%, 25.2% and 13.7%, respectively, of total research and development costs.
Previous report
Cash
Previous report
Cash is held in a cash bank deposit program maintained by Morgan Stanley Wealth Management, a division of Morgan Stanley Smith Barney LLC (“Morgan Stanley”). Morgan Stanley is a FINRA-regulated broker-dealer. The Company’s policy is to maintain its cash balances with financial institutions in the United States with high credit ratings and in accounts insured by the Federal Deposit Insurance Corporation (the “FDIC”) and/or by the Securities Investor Protection Corporation (the “SIPC”). The Company periodically has cash balances in financial institutions in excess of the FDIC and SIPC insurance limits of $250,000 and $500,000, respectively. Morgan Stanley Wealth Management also maintains supplemental insurance coverage for the cash balances of its customers. The Company has not experienced any losses to date resulting from this policy.
Previous report
Segment Information
Previous report
The Company’s President and Chief Executive Officer is the Company’s Chief Operating Decision Maker (“CODM”) and evaluates performance and makes operating decisions about allocating resources based on internal financial data presented on a consolidated basis. Because the CODM evaluates financial performance on a consolidated basis, the Company has determined that it operates in a single reportable segment, which consists of the development of a drug class called Protein Phosphatase 2A inhibitors, and is comprised of the consolidated financial results of the Company. The CODM uses consolidated net income (loss) as the sole measure of segment profit or loss.
Previous report
In November 2023, the Financial Accounting Standards Board (“FASB”) issued Accounting Standards Update (“ASU”) 2023-07, Segment Reporting (Topic 280): Improvements to Reportable Segment Disclosure. ASU 2023-07 amends the FASB Accounting Standards Codification to require additional reportable segment disclosures of a public entity by requiring disclosure of significant segment expenses that are regularly provided to the chief operating decision maker, requiring other new disclosures, and requiring enhanced interim disclosures. ASU 2023-07 requires public entities with a single reportable segment to provide all the disclosures required by ASU 2023-07 and all existing segment disclosures in Topic 280 on an interim and annual basis. The Company adopted ASU 2023-07 effective January 1, 2024 for the 2024 annual period on a retrospective basis. The adoption of ASU 2023-07 resulted in additional required segment-related disclosures in the Company’s financial statements.
Previous report
Due to the significant uncertainty associated with the successful development of commercially viable products based on the Company’s research efforts and related patent applications, all patent and licensing legal and filing fees and costs related to the development and protection of the Company’s intellectual property are charged to operations as incurred. Patent and licensing legal and filing fees and costs are included in general and administrative costs in the Company’s consolidated statement of operations.
Previous report
In September 2023, the Company appointed a new President and Chief Executive Officer, who, with the assistance of the Company’s management, Board of Directors and patent legal counsel, conducted a comprehensive review and analysis of the Company’s extensive 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 develop and expand its patent portfolio related to the clinical development of LB-100.
Previous report
As a result of such review and analysis, patent and licensing legal and filing fees and costs related to the development and protection of the Company’s intellectual property, primarily related to LB-100, decreased to $243,186 for the year ended December 31, 2024, as compared to $978,244 for the year ended December 31, 2023, a decrease of $735,058, or 75.1%.
Previous report
A descriptive summary of the patent portfolio for the Company’s most important clinical programs involving the development of LB-100, as well as a detailed listing of each domestic and international patent that has been issued, is presented at “ITEM 1. BUSINESS – Intellectual Property”.
Previous report
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.
Previous report
For the year ended December 31, 2023, general and administrative costs were $4,192,136, which consisted of the fair value of vested stock options issued to directors and officers of $773,203, patent and licensing legal and filing fees and costs of $978,244, other consulting and professional fees of $655,854, insurance expense of $442,976, officer salaries and related costs of $841,709, cash-based director and board committee fees of $163,479, shareholder reporting costs of $93,860, listing fees of $62,000, filing fees of $17,125, taxes and licenses of $73,877, investor relations of $59,238, rent of $15,571 and other operating costs of $24,109, offset by a credit to licensing fees of $9,109 relating to the termination of the Moffitt agreement.
Previous report
Going Concern
Previous report
The Company’s consolidated financial statements have been presented on the basis that it will continue as a going concern, which contemplates the realization of assets and satisfaction of liabilities in the normal course of business. The 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 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.
Previous report
Based on the foregoing, management has concluded that there is substantial doubt about the Company’s ability to continue as a going concern within one year after the date that the consolidated financial statements are being issued. In addition, the Company’s independent registered public accounting firm has included an explanatory paragraph in their report with respect to this uncertainty that accompanies the Company’s audited consolidated financial statements as of and for the year ended December 31, 2024. The Company’s independent registered public accounting firm, in their report on the Company’s December 31, 2024 audited consolidated financial statements, has expressed substantial doubt about the Company’s ability to continue as a going concern. The Company’s consolidated financial statements do not include any adjustments that might result from the outcome of this uncertainty.
Previous report
Based on current operating plans, the Company estimates that its existing cash resources at December 31, 2024, and the funds raised subsequent to December 31, 2024, will provide sufficient working capital to fund the current clinical trial program with respect to the development of the Company’s lead anti-cancer clinical compound LB-100 through approximately September 30, 2025. However, existing cash resources will not be sufficient to complete the development of and obtain regulatory approval for the Company’s product candidate, which will require that the Company raise significant additional capital. The Company estimates that it will need to raise additional capital to fund its operations by mid-2025 to be able to proactively manage its current business plan during the remainder of 2025 and during 2026. In addition, the Company’s operating plans may change as a result of many factors that are currently unknown and/or outside of the control of the Company, and additional funds may be needed sooner than planned. The Company is considering various strategies and alternatives to obtain the required additional capital. However, as market conditions present uncertainty as to the Company’s ability to secure additional funds, there can be no assurance that the Company will be able to secure additional financing on acceptable terms, as and when necessary, to continue to conduct operations.
Previous report
If cash resources are insufficient to satisfy the Company’s ongoing cash requirements, the Company would be required to scale back or discontinue its clinical trial program, as well as its licensing and patent prosecution efforts and its technology and product development efforts, or obtain funds, if available, through strategic alliances, joint ventures or other transaction structures that could require the Company to relinquish rights to and/or control of LB-100, or to curtail or discontinue operations entirely.
Previous report
At March 14, 2025, the Company’s remaining financial contractual commitments pursuant to clinical trial agreements and clinical trial monitoring agreements not yet incurred aggregated $526,000, which are currently scheduled to be incurred through approximately December 31, 2027.
Previous report
Clinical Trial Agreements
Previous report
**Moffitt.**Effective August 20, 2018, the Company entered into a Clinical Trial Research Agreement with the Moffitt Cancer Center and Research Institute Hospital Inc., Tampa, Florida (“Moffitt”), effective for a term of five years. Pursuant to the Clinical Trial Research Agreement, Moffitt agreed to conduct and manage a Phase 1b/2 clinical trial to evaluate the toxicity and therapeutic benefit of the Company’s lead anti-cancer clinical compound LB-100 to be administered intravenously in patients with low or intermediate-1 risk myelodysplastic syndrome (“MDS”).
Previous report
In November 2018, the Company received approval from the U.S. Food and Drug Administration for its Investigational New Drug (“IND”) Application to conduct a Phase 1b/2 clinical trial to evaluate the toxicity and therapeutic benefit of LB-100 in patients with low and intermediate-1 risk MDS who had failed or were intolerant of standard treatment. This Phase 1b/2 clinical trial utilized LB-100 as a single agent in the treatment of patients with low and intermediate-1 risk MDS.
Previous report
The clinical trial began at a single site in April 2019 and the first patient was entered into the clinical trial in July 2019. During the year ended December 31, 2023, the clinical trial was closed. Although the maximum tolerated dose (“MTD”) was not achieved, there was no dose-limiting toxicity noted.
Previous report
During the years ended December 31, 2024 and 2023, the Company incurred costs of $0 and $16,165, respectively, pursuant to this agreement. As of December 31, 2024, total costs of $147,239 had been incurred pursuant to this agreement.
Previous report
During September 2023, the Company decided not to pursue further studies in MDS, as other, more promising, opportunities had become available (see “Patent and License Agreements - Moffitt” below).
Previous report
**National Cancer Institute Pharmacologic Clinical Trial.**In May 2019, the National Cancer Institute (“NCI”) initiated a glioblastoma (“GBM”) pharmacologic clinical trial. This study was being conducted and funded by the NCI under a Cooperative Research and Development Agreement, with the Company responsible for providing the LB-100 clinical compound.
Previous report
Primary malignant brain tumors (gliomas) are very challenging to treat. Radiation combined with the chemotherapeutic drug temozolomide has been the mainstay of therapy of the most aggressive gliomas (glioblastoma multiforme or GBM) for decades, with little further benefit gained by the addition of one or more anti-cancer drugs, but without major advances in overall survival for the majority of patients. In animal models of GBM, the Company’s novel protein phosphatase inhibitor, LB-100, has been found to enhance the effectiveness of radiation, temozolomide chemotherapy treatments and immunotherapy, raising the possibility that LB-100 may improve outcomes of standard GBM treatment in the clinic. Although LB-100 has proven safe in patients at doses associated with apparent anti-tumor activity against several human cancers arising outside the brain, the ability of LB-100 to penetrate tumor tissue arising in the brain was not known. Many drugs potentially useful for GBM treatment do not enter the brain in amounts necessary for anti-cancer action.
Previous report
The NCI study was designed to determine the extent to which LB-100 enters recurrent malignant gliomas. Patients having surgery to remove one or more tumors received one dose of LB-100 prior to surgery and had blood and tumor tissue analyzed to determine the amount of LB-100 present and to determine whether the cells in the tumors showed the biochemical changes expected to be present if LB-100 reached its molecular target. As a result of the innovative design of the NCI study, it was believed that data from a few patients would be sufficient to provide a sound rationale for conducting a larger clinical trial to determine the effectiveness of adding LB-100 to the standard treatment regimen for GBMs. Blood and brain tumor tissue were analyzed from seven patients after intravenous infusion of a single dose of LB-100. Results of the investigation demonstrated that there was virtually no entry of LB-100 into the brain tumor tissue. Accordingly, alternative methods of drug delivery will be required to determine if LB-100 has meaningful clinical anti-cancer activity against glioblastoma multiforme and other aggressive brain tumors.
Previous report
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.
Showing the first 40 of 44 passages. Open the source sections for the rest.
Reworded paragraphs (42)
Previous wording
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.
Current wording
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 is the majority shareholder of Liora Technologies Europe Ltd., which is pioneering the development of electronically controlled proton therapy systems for treating tumors in various types of cancers. The Company’s corporate office is located in Boca Raton, Florida.
Previous wording
The Company’s common stock and the warrants are traded on the Nasdaq Capital Market under the symbols “LIXT” and “LIXTW”, respectively.
Current wording
The Company’s common stock is traded on the Nasdaq Capital Market under the symbol “LIXT”.
Previous wording
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.
Current wording
Research and development costs are charged to expense as incurred. The costs of equipment that are acquired or constructed for research and development activities, and have alternative future uses, are classified as property and equipment and depreciated over their estimated useful lives. Research and development costs consist primarily of fees paid to consultants and contractors, and other expenses relating to the negotiation, design, development, conduct and management of clinical trials with respect to the Company’s clinical compound and product candidate. Research and development costs also include the costs to manufacture compounds used in research and clinical trials, which are charged to operations as incurred. The Company’s inventory of LB-100 for clinical use has been manufactured separately in the United States and in the European Union in accordance with the laws and regulations of such jurisdictions.
Previous wording
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.
Current wording
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.
Previous wording
The Company accounts for warrants as either equity-classified or liability-classified instruments based on an assessment of the warrant’s specific terms and applicable authoritative guidance in Accounting Standards Codification (“ASC”) 480, Distinguishing Liabilities from Equity (“ASC 480”), and ASC 815, Derivatives and Hedging (“ASC 815”). The assessment considers whether the warrants are freestanding financial instruments pursuant to ASC 480, meet the definition of a liability pursuant to ASC 480, and whether the warrants meet all of the requirements for equity classification under ASC 815, including whether the warrants are indexed to the Company’s own common stock and whether the warrant holders could potentially require “net cash settlement” in a circumstance outside of the Company’s control, among other conditions for equity classification. The Company has determined that the warrants issued in the July 20, 2023 equity financing meet the requirements for equity classification. This assessment, which requires the use of 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 December 31, 2024 and 2023, the Company did not have any liability-classified warrants.
Current wording
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. 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 reporting date. Effective November 28, 2025, the Company delisted its public warrants that traded under the symbol “LIXTW”. At December 31, 2025 and 2024, the Company did not have any liability-classified warrants.
Previous wording
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, which has been shown to have clinical anti-cancer activity.
Current wording
The Company is a clinical-stage biopharmaceutical and proton cancer therapy company focused on identifying new targets for cancer drug development and developing and commercializing cancer therapies. The Company’s product pipeline is primarily focused on inhibitors of protein phosphatase 2A, which is used to enhance cytotoxic agents, radiation, immune checkpoint blockers and other cancer therapies. The Company believes that inhibitors of protein phosphatases have significant therapeutic potential for a broad range of cancers. The Company is focusing on the clinical development of a specific protein phosphatase inhibitor, referred to as LB-100, which has been shown to have clinical anti-cancer activity.
Previous wording
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 is preparing 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.
Current wording
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 has prepared a response to the IRB detailing the safety experience with LB-100 given alone and in combination with other cancer drugs, especially doxorubicin and dostarlimab. Doxorubicin is a well-known chemotherapy, and dostarlimab is a well-known immunotherapy of which the mode of action is closely related to that of atezolizumab.
Previous wording
The reported adverse events in the colorectal cancer study have not been seen in any other patients thus far treated with LB-100 alone or in combination with other cancer drugs. Through February 2025, a total of 78 patient have received or are receiving experimental treatment with LB-100. It is expected that it will take at least two months to prepare a detailed response to the IRB, during which time the Company intends to update the safety overview of LB-100.
Current wording
The reported adverse events in the colorectal cancer study have not been seen in any other patients thus far treated with LB-100 alone or in combination with other cancer drugs. Through February 2025, a total of 78 patient have received or are receiving experimental treatment with LB-100. The investigators have completed the IRB review in Q4 2025 and the trial is open again for enrolment Q1 2026.
Previous wording
**Supply Chain Issues.**The Company does not currently expect that supply chain issues will have a significant impact on its business activities, including its ongoing clinical trials.
Current wording
**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 in the US. Our current batch of LB-100 in Europe expires by European Law after 5 years, which will be Q4 2026. We are looking to extend the shelf life with an additional 12 months until Q4 2027. If we do not manage to extend the shelf life or are not able to manufacture a new batch we might not be able to complete the enrollment in the Colon Cancer Trail at the NKI.
Previous wording
Research and Development Costs. For the year ended December 31, 2024, research and development costs were $726,232, which consisted of clinical and related oversight costs of $377,958, regulatory service costs of $18,836, and preclinical research focused on development of additional novel anti-cancer compounds to add to the Company’s clinical pipeline of $329,438.
Current wording
Research and Development Costs. For the years ended December 31, 2025 and December 31, 2024, research and development costs were $254, 919 and $726,232, respectively. These costs consisted of clinical and related oversight costs of $57,193 and $377,958, respectively, regulatory service costs of $9,050 and $18,836, respectively and preclinical research focused on development of additional novel anti-cancer compounds of 188,675 and $329,438, respectively, for the years ended December 31, 2025 and December 31, 2024.
Previous wording
Effective June 10, 2024, the Company entered into a Clinical Trial Agreement with the Netherlands Cancer Institute (“NKI”) to conduct a Phase 1b/2 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 metastatic colon cancer. NKI employs Dr. René Bernards, a director of the Company since June 15, 2022. The Company has no financial contractual commitment associated with this clinical trial.
Current wording
Effective June 10, 2024, the Company entered into a Clinical Trial Agreement with the Netherlands Cancer Institute (“NKI”) to conduct a Phase 1b/2 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 metastatic colon cancer. NKI employs Dr. René Bernards, a director of the Company since June 15, 2022 until his resignation from the Board on August 18, 2025. Dr. Bernards was then appointed as Chairman of the Company’s Scientific Advisory Committee. The Company has no financial contractual commitment associated with this clinical trial.
Previous wording
Research and development costs decreased by $171,868, or 19.1%, in 2024 as compared to 2023, primarily as a result of a decrease in preclinical research focused on development of additional novel anti-cancer compounds to add to the Company’s clinical pipeline of $133,655.
Current wording
Research and development costs decreased by $471,313, or 64.9%, in 2025 as compared to 2024, primarily as a result of a decrease in preclinical research focused on development of additional novel anti-cancer compounds to add to the Company’s clinical pipeline of $133,655.
Previous wording
Patent and Licensing Legal and Filing Fees and Costs
Current wording
General and Administrative Costs. For the year ended December 31, 2025, general and administrative costs were $4,852,702 which consisted of the fair value of vested stock options issued to directors and officers of $1,527,855 (including quarterly director and board committee fees of $55,000), lease expense of $61,695, patent and licensing legal and filing fees and costs of $112,092, other consulting and professional fees of $1,431,118, insurance expense of $257,478, officer salaries and related costs of $694,827, cash-based director and board committee fees of $27,500, legal settlement of $100,000, licensing and royalties of $30,000, shareholder reporting costs of $68,939, litigation settlement of $100,000, listing fees of $73,000, filing fees of $23,559, investor relations of $372,387, rent of $2,093, and other operating costs of $97,656.
Previous wording
General and Administrative Costs. For the year December 31, 2024, general and administrative costs were $2,846,557, which consisted of the fair value of vested stock options issued to directors and officers of $418,422 (including quarterly director and board committee fees of $55,000), patent and licensing legal and filing fees and costs of $243,186, other consulting and professional fees of $735,021, insurance expense of $434,444, officer salaries and related costs of $691,244, cash-based director and board committee fees of $38,819, licensing and royalties of $75,643, shareholder reporting costs of $41,488, listing fees of $49,500, filing fees of $28,012, investor relations of $59,588, rent of $16,435, conference fees of $14,475 and other operating costs of $45,830, offset by a state franchise tax credits of $45,550.
Current wording
For the year ended December 31, 2024, general and administrative costs were $2,846,557, which consisted of the fair value of vested stock options issued to directors and officers of $418,422 (including quarterly director and board committee fees of $55,000), patent and licensing legal and filing fees and costs of $243,186, other consulting and professional fees of $735,021, insurance expense of $434,444, officer salaries and related costs of $691,244, cash-based director and board committee fees of $38,819, shareholder reporting costs of $41,488, listing fees of $49,500, filing fees of $28,012, investor relations of $59,588, rent of $16,435, conference fees of $14,475 and other operating costs of $45,830, offset by a state franchise tax credits of $45,550.
Previous wording
General and administrative costs decreased by $1,345,579, or 32.1%, in 2024 as compared to 2023, primarily as a result of a decrease in the fair value of vested stock options issued to directors and officers of $354,781, a decrease in patent and licensing legal and filing fees and costs of $735,058, a decrease in officer salaries and related costs of $150,465, a decrease in shareholder reporting costs of $52,372, a decrease in taxes and licenses of $119,427, and a decrease in cash-based director and board committee fees of $124,660, offset by increases in licensing and royalties of $84,752, and in other consulting and professional fees of $79,167.
Current wording
General and administrative costs increased by $2,006,145, or 70.0%, in 2025 as compared to 2024, primarily as a result of an increase in the fair value of vested stock options issued to directors and officers of $1,054,443, an increase in other consulting and professional fees $696,097, an increase in other costs and expenses of $280,172, offset by decreases in insurance expense of $176,964, decrease in patent and licensing legal and filing fees and costs of $131,094 and decrease in board fees by $11,319.
Previous wording
Interest Income. For the year ended December 31, 2024, the Company had interest income of $7,048, as compared to interest income of $17,486 for the year ended December 31, 2023, related to the investment of the Company’s cash resources.
Current wording
Interest Income. For the year ended December 31, 2025, the Company had interest income of $7,388, as compared to interest income of $7,048 for the year ended December 31, 2024, related to the investment of the Company’s cash resources.
Previous wording
Interest Expense. For the year ended December 31, 2024, the Company had interest expense of $16,821, as compared to interest expense of $16,233 for the year ended December 31, 2023, related to the financing of the premium for the Company’s directors and officers liability insurance policy.
Current wording
Interest Expense. For the year ended December 31, 2025, the Company had interest expense of $9,158, as compared to interest expense of $16,821 for the year ended December 31, 2024, related to the financing of the premium for the Company’s directors and officers liability insurance policy.
Previous wording
Foreign Currency Gain (Loss). For the year ended December 31, 2024, the Company had a foreign currency loss of $3,403, as compared to a foreign currency gain of $1,954 for the year ended December 31, 2023, from foreign currency transactions.
Current wording
Foreign Currency Gain (Loss). For the year ended December 31, 2025, the Company had a foreign currency gain of $525, as compared to a foreign currency loss of $3,403 for the year ended December 31, 2024, from foreign currency transactions.
Previous wording
Net Loss. For the year ended December 31, 2024, the Company incurred a net loss of $3,585,965, as compared to a net loss of $5,087,029 for the year ended December 31, 2023.
Current wording
Net Loss. For the year ended December 31, 2025, the Company incurred a net loss of $6,009,520, as compared to a net loss of $3,585,965 for the year ended December 31, 2024.
Previous wording
At December 31, 2024, the Company had working capital of $827,219, as compared to working capital of $3,994,762 at December 31, 2023, reflecting a decrease in working capital of $3,167,543 for the year ended December 31, 2024. The decrease in working capital during the year ended December 31, 2024 was primarily the result of the funding of the Company’s ongoing research and development activities and other ongoing operating expenses, including maintaining and developing the Company’s patent portfolio. At December 31, 2024, the Company had cash of $1,038,952 available to fund its operations. Subsequently, the Company completed a securities offering that generated gross proceeds of $1,050,003 during February 2025 before deducting the placement agent’s fees and related offering expenses.
Current wording
At December 31, 2025, the Company had working capital of $3,845,268, as compared to working capital of $827,219 at December 31, 2024, reflecting an increase in working capital of $3,018,049 for the year ended December 31, 2025. The increase in working capital during the year ended December 31, 2025 was primarily the result of the Company’s completed securities offerings on February 13, July 8, and December 22, 2025 and private placement completed on July 2, 2025 that generated gross proceeds of $10,311,000, net after deducting the placement agent’s fees and related offering expenses during 2025.
Previous wording
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 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 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.
Current wording
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.
Previous wording
Based on the foregoing, management has concluded that there is substantial doubt about the Company’s ability to continue as a going concern within one year after the date that the consolidated financial statements are being issued. The Company’s consolidated financial statements do not include any adjustments that might result from the outcome of this uncertainty.
Current wording
The consolidated financial statements have been prepared assuming the Company will continue as a going concern and do not include any adjustments that might result from the outcome of this uncertainty.
Previous wording
Operating Activities. For the year ended December 31, 2024, operating activities utilized cash of $3,164,536, as compared to utilizing cash of $4,293,265 for the year ended December 31, 2023, to fund the Company’s ongoing research and development activities and to fund its other ongoing operating expenses, including maintaining and developing its patent portfolio.
Current wording
Operating Activities. For the year ended December 31, 2025, operating activities utilized cash of $3,070,618, as compared to utilizing cash of $3,164,536 for the year ended December 31, 2024, to fund the Company’s ongoing research and development activities and to fund its other ongoing operating expenses, including maintaining and developing its patent portfolio.
Previous wording
Investing Activities. For the years ended December 31, 2024 and 2023, the Company had no investing activities.
Current wording
Investing Activities. For the year ended December 31, 2025, the Company had investing activities for the cash portion of the purchase of Liora in the amount of $440,000 and purchase of digital assets $2,637,360, that were transferred to the third party seller for the Investment in Liora. In addition, capitalized transaction costs totaled $95,102. For the year ended December 31, 2024, the Company had no investing activities.
Previous wording
Financing Activities. For the year ended December 31, 2024, the Company had no financing activities. For the year ended December 31, 2023, financing activities consisted primarily of the gross proceeds from the sale of securities in the Company’s registered direct offering of $3,499,964, reduced by offering costs of $362,925, and $6,281 from the exercise of common stock options.
Current wording
Financing Activities. For the year ended December 31, 2025, financing activities consisted primarily of the gross proceeds from the sale of securities in the Company’s registered direct offering of $11,900,000, reduced by offering costs of $1,634,801 and $45,801 from the exercise of common stock options.. For the year ended December 31, 2024, the Company had no financing activities.
Previous wording
At March 14, 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 $526,000, including clinical trial agreements of $264,000 and clinical trial monitoring agreements of $262,000, 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.
Current wording
At December 31, 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 $496,000, including clinical trial agreements of $293,000 and clinical trial monitoring agreements of $203,000, 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.
Previous wording
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 (see “Specific Risks Associated with the Company’s Business Activities – Serious Adverse Events” above for additional information).
Current wording
The principal investigator of the colorectal study testing LB-100 in combination with atezolizumab has completed the investigation into two Serious Adverse Events (“SAEs”) observed in the clinical trial (see “Specific Risks Associated with the Company’s Business Activities – Serious Adverse Events” above for additional information).
Previous wording
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 December 31, 2024.
Current wording
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 December 31, 2025 and 2024.
Previous wording
During the year ended December 31, 2024 and 2023, the Company incurred costs of $285,019 and $69,001, respectively, pursuant to this Agreement. As of December 31, 2024, total costs of $732,532 had been incurred pursuant to this Agreement.
Current wording
During the year ended December 31, 2025 and 2024, the Company incurred costs of $0 and $285,019, respectively, pursuant to this Agreement. As of December 31, 2025, total costs of $732,532 had been incurred pursuant to this Agreement.
Previous wording
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.
Current wording
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, the Phase 2 portion of this clinical trial will not proceed, and the trial will be closed after completion of the first phase in Q1 2026.
Previous wording
The Company’s agreement with GEIS provided for various payments based on achieving specific milestones over the term of the agreement. During the years ended December 31, 2024 and 2023, the Company incurred costs of $0 and $268,829, respectively, pursuant to this agreement. Through December 31, 2024, the Company has incurred charges of $684,652 for work done under this agreement through the fourth milestone.
Current wording
The Company’s agreement with GEIS provided for various payments based on achieving specific milestones over the term of the agreement. During the years ended December 31, 2025 and 2024, the Company incurred costs of $0 and $268,829, respectively, pursuant to this agreement.
Previous wording
The Company’s aggregate commitment pursuant to this agreement, less amounts previously paid to date, totaled approximately $264,000 for the Phase 1b portion of this clinical trial as of March 14, 2025, which is 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.
Current wording
The Company’s aggregate commitment pursuant to this agreement, less amounts previously paid to date, totaled approximately $293,000 for the Phase 1b portion of this clinical trial as of December 31, 2025, which is scheduled to be incurred Q1, 2026. 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.
Previous wording
Costs under this letter of intent and related work order agreement are estimated to be approximately $95,000. During the year ended December 31, 2024, the Company incurred costs of $26,763 pursuant to this letter of intent and subsequent work order. As of December 31, 2024, total costs of $26,763 have been incurred pursuant to this letter of intent and subsequent work order.
Current wording
Costs under this letter of intent and related work order agreement are estimated to be approximately $95,000. During the year ended December 31, 2025 and 2024, the Company incurred costs of $21,706 and $26,763, respectively, pursuant to this letter of intent and subsequent work order. As of December 31, 2025, total costs of $46,598 have been incurred pursuant to this letter of intent and subsequent work order.
Previous wording
The Company’s aggregate commitment pursuant to this letter of intent, less amounts previously paid to date, totaled approximately $70,000 as of December 31, 2024, which is expected to be incurred through December 31, 2027.
Current wording
The Company’s aggregate commitment pursuant to this letter of intent, less amounts previously paid to date, totaled approximately $48,000 as of December 31, 2025, which is expected to be incurred through December 31, 2027.
Previous wording
**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 years December 31, 2024 and 2023, the Company incurred costs of $10,642 and $20,240, respectively, pursuant to this work order. As of December 31, 2024, total costs of $89,323 had been incurred pursuant to this work order agreement.
Current wording
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 years December 31, 2025 and 2024, the Company incurred costs of $0 and $10,642, respectively, pursuant to this work order. As of December 31, 2025, total costs of $89,323 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, the work order was terminated on July 8, 2024.
Previous wording
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 years ended December 31, 2024 and 2023, the Company incurred costs of $34,593 and $14,862, respectively, pursuant to this work order. As of December 31, 2024, total costs of $49,455 have been incurred pursuant to this work order agreement.
Current wording
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 years ended December 31, 2024 and 2023, the Company incurred costs of $34,593 and $14,862, respectively, pursuant to this work order.
Previous wording
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 is included in other prepaid expenses at December 31, 2024 in the accompanying consolidated balance sheet.
Current wording
The Company paid NIH a non-creditable, non-refundable license issue royalty of $50,000. 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 second minimum annual royalty for 2025 of $30,000, was paid in December 2024 and is included in other prepaid expenses at December 31, 2024 in the accompanying consolidated balance sheet.
Previous wording
During the year ended December 31, 2024, the Company incurred costs of $75,643 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 December 31, 2024, total costs of $75,643 have been incurred pursuant to this agreement. The Company’s aggregate commitment pursuant to this agreement, less amounts previously paid to date, totaled approximately $1,795,000 as of December 31, 2024, which is expected to be incurred over approximately the next twenty years.
Current wording
During the years ended December 31, 2025 and 2024, the Company incurred costs of $30,000 and $75,643 in connection with its obligations under the License Agreement. The Company’s aggregate commitment pursuant to this agreement, less amounts previously paid to date, totaled approximately $1,765,000 as of December 31, 2025, which is expected to be incurred over approximately the next nineteen years.
Previous wording
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.
Current wording
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 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. Effective March 1, 2024, the compensation payable under the Collaboration Agreement was converted to an hourly rate structure.
Previous wording
The Company recorded charges to operations pursuant to this Collaboration Agreement of $39,200 and $120,000 during the years ended December 31, 2024 and 2023, respectively, which were included in research and development costs in the consolidated statements of operations.
Current wording
The Company recorded charges to operations pursuant to this Collaboration Agreement of $59,600 and $39,200 during the years ended December 31, 2025 and 2024, respectively, which were included in research and development costs in the consolidated statements of operations.
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Previous report — wording carried elsewhere
For the year ended December 31, 2023, research and development costs were $898,100, which consisted of clinical and related oversight costs of $416,269, regulatory service costs of $18,738, and preclinical research focused on development of additional novel anti-cancer compounds to add to the Company’s clinical pipeline of $463,093.
Previous report — wording carried elsewhere
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 and to ultimately achieve sustainable operating revenues and profitability. The amount and timing of future cash requirements depends on the pace, design, and results of the Company’s clinical trial program, which, in turn, depends on the availability of operating capital to fund such activities.
Previous report — wording carried elsewhere
The Company’s aggregate commitment pursuant to this contract, less amounts previously paid to date, totaled approximately $118,000 as of December 31, 2024.