1. Organization and Basis of Presentation

The unaudited condensed consolidated financial statements as of March 31, 2026, and for the three months ended March 31, 2026 and 2025, of Lixte Biotechnology Holdings, Inc. (a Delaware corporation), include the accounts of Lixte Biotechnology, Inc. (a wholly-owned Delaware corporation), and Liora Technologies Europe Ltd. (“Liora”, an 80% owned corporation organized under the laws of England and Wales) (collectively, the “Company”).

In the opinion of management of the Company, all adjustments, including normal recurring accruals, have been made that are necessary to present fairly the financial position of the Company as of March 31, 2026, and the results of its operations for the three months ended March 31, 2026, and its cash flows for the three months ended March 31, 2026. Operating results for the interim periods presented are not necessarily indicative of the results to be expected for a full fiscal year. The condensed consolidated balance sheet at December 31, 2025 has been derived from the Company’s audited consolidated financial statements at such date.

The condensed consolidated financial statements and related notes have been prepared pursuant to the rules and regulations of the Securities and Exchange Commission (“SEC”). Accordingly, certain information and footnote disclosures normally included in financial statements prepared in accordance with generally accepted accounting principles have been omitted pursuant to such rules and regulations. These condensed consolidated financial statements should be read in conjunction with the financial statements and other information included in the Company’s Annual Report on Form 10-K for the fiscal year ended December 31, 2025, as filed with the SEC.

Business

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 drug 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.

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.

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 infusions of equity capital to fund its operating requirements.

Going Concern

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

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 $483,000 which are expected to be incurred through December 31, 2027.

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

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.

Nasdaq Compliance

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

On August 23, 2024, the Company received written notification from the Listing Qualifications Department (the “Staff”) of the Nasdaq Stock Market LLC (“Nasdaq”) that the Company was not in compliance with the minimum stockholders’ equity requirement of $2,500,000 for continued listing on the Nasdaq Capital Market under Listing Rule 5550(b) (the “Stockholders’ Equity Requirement”). On October 3, 2024, the Company submitted a plan to the Staff to regain compliance with the Stockholders’ Equity Requirement. On October 21, 2024, the Staff provided written notification to the Company that it had granted an extension through February 18, 2025 to regain compliance with the Stockholders’ Equity Requirement. As of February 18, 2025, the Company had not gained compliance with the Stockholders’ Equity Requirement. Accordingly, on February 19, 2025, the Company received written notification from the Staff stating that the Company did not meet the terms of the extension because it did not complete its proposed financing initiatives to regain compliance. The Company timely requested a hearing before the Nasdaq Hearings Panel (“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. 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.

2. Summary of Significant Accounting Policies

3. Segment Information

The Company’s chief operating decision maker (“CODM”) has been identified as the Company’s Chief Executive Officer (“CEO”). The Company’s CODM evaluates performance and makes operating decisions about allocating resources based on financial data presented on a consolidated basis. Because the CODM evaluates financial performance on a consolidated basis, the Company has determined that it currently has a single 1operating segment which is comprised of the consolidated financial results of the Company.

4. Acquisition of Liora Technologies Europe Ltd.

On November 21, 2025, the Company entered into a share exchange agreement to acquire Liora from Orbit Capital. The acquisition was executed through multiple agreements, including (i) an initial share exchange agreement dated November 21, 2025 (the “Original SEA”); (ii) a subsequent share exchange agreement dated December 30, 2025 (the “Post-Closing SEA”); and (iii) an amended and restated agreement dated March 6, 2026 (the “A&R Agreement”). The Post-Closing SEA finalized the structure such that Lixte owned 80% of Liora and Orbit Capital owned 20% of Liora. In addition there was a royalty agreement between the Company and Orbit dated November 21, 2025, that was terminated on December 16, 2025. As of March 31, 2026 and December 31, 2025, the Company owns 80% of Liora and consolidates Liora, with the remaining 20% ownership interest presented as noncontrolling interest.

The Company evaluated whether the acquisition met the definition of a business. Management determined that substantially all of the fair value of the assets acquired is concentrated in the LiGHT proton therapy system equipment, and that the acquisition of Liora did not include substantive processes or an organized workforce. Accordingly, the acquisition does not meet the definition of a business and is accounted for as an asset acquisition.

In January 2026, the Company capitalized an additional $24,859 of direct acquisition costs consisting primarily of UK stamp duty fees, increasing the recorded cost basis of the acquired LIGHT proton therapy system equipment to $6,607,419.

The LiGHT system is presented as a consolidated asset. The 20% ownership retained by Orbit is presented as noncontrolling interest in equity. The LiGHT system is a tangible long-lived asset. The LIGHT system is currently not operational and requires recommissioning, upgrades, and regulatory clearance. Accordingly, the asset is classified as property and equipment and treated as an asset under construction until it is ready for its intended use.

Contingent consideration

Liora’s purchase of the LiGHT system from AVO included deferred milestone-based payments of $5 million, which Lixte assumed with the purchase of the LiGHT system. The deferred consideration is contingent upon specified future milestones. As of December 31, 2025, no amounts have been recognized related to these contingent payments. Accordingly, the deferred consideration should be evaluated under the applicable contingency guidance and recognized when the recognition threshold is met. Until that time, the deferred contingent amounts should be disclosed, as appropriate, but not recorded as part of the initial purchase price allocation.

Lease accounting

The LiGHT machine is located in a leased facility. After the acquisition of the LiGHT machine from AVO, Liora entered into a two year operating lease with the Daresbury Laboratory site on November 17, 2025. The Company assumed the lease obligations and is accounting for the lease under ASC 842, including recognition of a right-of-use asset and lease liability (see Note 5). Currently, the Company expects that the LiGHT machine will continue to be housed at this location on a long-term basis.

5. Leases

On November 21, 2025, the Company assumed, as part of the Liora acquisition, a two-year lease agreement with United Kingdom Research and Innovation for the rental of the premises at UKRI Daresbury that houses the acquired LiGHT system equipment. The lease was classified as an operating lease and has a quarterly base rent of GBP 147,596 or approximately $198,500. The lease commencement date was November 17, 2025 and has no renewal option. The Company recognized a right-of-use asset and corresponding lease liability of $1,043,437 for the UKRI Daresbury Lease.

The Company’s operating lease right of use asset was $972,682 as of December 31, 2025. During the three months ended March 31, 2026, the Company recorded noncash operating lease expense of $122,553, resulting in an operating lease right of use asset of $850,129 as of March 31, 2026.

The Company’s operating lease liability balance was $1,034,377 as of December 31, 2025. During the three months ended March 31, 2026, the Company was not required to make any lease payments against its operating lease obligations. During the three months ended March 31, 2026, the accretion of the lease liability was $22,813, resulting in a lease liability of $1,057,190 as of March 31, 2026. The current portion of operating lease obligation was $595,418, and a long-term portion of the operating lease obligation was $461,772.

During the three months ended March 31, 2026 and 2025, lease costs totaled approximately $83,860 and $77,061, respectively.

As of March 31, 2026, the weighted average remaining lease terms for operating lease is 1.63 years, and the weighted average discount rate for operating lease is 9.00%.

6. Stockholders’ Equity

Preferred Stock

The Company is authorized to issue a total of 10,000,000 shares of preferred stock, par value $0.0001 per share. On March 17, 2015, the Company filed a Certificate of Designations, Preferences, Rights and Limitations of its Series A Convertible Preferred Stock with the Delaware Secretary of State to amend the Company’s certificate of incorporation. The Company has designated a total of 350,000 shares as Series A Convertible Preferred Stock, which are non-voting.

On October 21, 2025, the Company filed a Certificate of Elimination of Certificate of Designations of Series A Convertible Preferred Stock with the Delaware Secretary of State to eliminate the 350,000 shares of Preferred Stock associated with the Series A Convertible Preferred Stock classification.

On July 1, 2025, the Company filed amendment to Certificate of Incorporation by filing Certificate of Designations, Preferences, Rights and Limitations of its Series B Convertible Preferred Stock with the Delaware Secretary of State. The Company has designated a total of 3,573,130 shares as Series B Convertible Preferred Stock with a stated value of $0.7146 per share. Each Preferred Share is convertible into one share of Common Stock, subject to standard adjustments such as stock splits and stock dividends. The Preferred Shares are non-voting, except that certain actions of the Company may not be taken except upon approval of holders who own a majority in stated value of the Preferred Shares. The Preferred Shares bear an 8% per annum cumulative dividend non-compounding and payable at conversion either in cash or, at the holder’s election, in shares of Common Stock valued at the then effective conversion rate.

As of March 31, 2026 and December 31, 2025 the Company had 10,000,000 and 7,576,870 shares respectively, of undesignated preferred stock, which may be issued with such rights and powers as the Board of Directors may designate.

Common Stock

The Company is authorized to issue a total of 100,000,000 shares of common stock, par value $0.0001 per share. As of March 31, 2026 and December 31, 2025, the Company had 11,632,944 shares and 8,790,102 shares, respectively, of common stock issued and outstanding.

2026 common stock transactions

Shares issued for services

On January 6, 2026, the Company entered into a consulting agreement with Pillow Hog Ventures, Inc (“PHVC”) for marketing and strategic consulting services. The agreement is for a term of six months ending June 30, 2026. The agreement provides for the payment to PHVC of 15,000 shares of the Company’s common stock.

Exercise of Preferred Series B Stock

During January and February 2026, holders of the Company’s Preferred Series B stock converted an aggregate of 2,423,130 preferred shares, together with accrued cumulative dividends of $86,955, into 2,544,821 shares of the Company’s common stock. Each preferred share was convertible into one share of common stock, with accrued 8% cumulative dividends payable upon conversion in additional shares of common stock at a conversion price of $0.7146 per share. As of March 31, 2026, no Preferred Series B shares remained outstanding.

Exercise of Pre-Funded Warrants

During the three months ended March 31, 2026, warrant holders exercised 283,021 pre-funded warrants resulting in the issuance of 283,021 shares of the Company’s common stock.

2025 common stock transactions

February 2025 equity offering

Effective February 13, 2025, the Company closed a registered direct offering with certain investors which resulted in gross proceeds of $1,050,003. After deducting placement agent fees and direct offering expenses of $135,775, the Company received net proceeds of $914,228. The Company sold and issued 434,784 shares of common stock at $2.415 per share. In a concurrent private placement, the Company also issued warrants to purchase 434,784 shares of common stock at an exercise price of $2.29 per share, exercisable immediately and expire five years from the date of issuance. The Company also granted the placement agent warrants to purchase 32,609 shares of common stock at $3.0188 per share, expiring February 11, 2030.

All warrants issued in the February 2025 equity offering include customary anti-dilution adjustments and a “fundamental transaction” provision. If a qualifying fundamental transaction within the Company’s control is consummated, holders may elect cash settlement equal to the Black-Scholes value. For fundamental transactions outside the Company’s control, holders are entitled to receive the same consideration as common shareholders. The warrants are classified in permanent equity. Any future cash settlements will be accounted for as equity distributions upon occurrence of the related fundamental transaction.

Common Stock Warrants

During the periods presented, the Company issued pre-funded warrants, each of which is exercisable immediately upon issuance at a de minimis exercise price of $0.00001 per share. Because the holders have already paid substantially all of the purchase price at issuance and the remaining exercise price is nominal, the pre-funded warrants are economically equivalent to outstanding common shares. The pre-funded warrants meet the criteria for equity classification. The warrants are indexed to the Company’s own stock, require physical settlement in shares, and do not include features that could require cash settlement.

Due to their economic characteristics, pre-funded warrants function as share-like instruments, rather than traditional warrants with a substantive exercise price or term. Therefore, including them together with standard warrants in the warrant rollforward would significantly distort both the weighted-average exercise price and the weighted-average remaining contractual life, rendering those disclosures not meaningful. As a result, the Company presents pre-funded warrants separately from standard common stock warrants in the tables below. The pre-funded warrants are excluded from weighted-average exercise price and remaining life due to their de-minimis strike price and share-like characteristics.

7. Related Party Transactions

Related party transactions include transactions with the Company’s officers, directors and affiliates.

Employment Agreements with Officers

Effective June 16, 2025, the Company entered into an employment agreement with Geordan Pursglove pursuant to which Mr. Pursglove was appointed as the Company’s Chief Executive Officer and Chairman of the Board of Directors for a term of three years, subject to automatic termination if the Company did not complete a successful financing that would enable it to maintain its listing on the Nasdaq Capital Market by July 3, 2025, which was accomplished on July 2, 2025. Under the employment agreement, Mr. Pursglove will receive an annual salary of $240,000, which was increased to $360,000 effective as of January 1, 2026. During the three months ended March 31, 2026 and 2025, the Company paid $90,000 and $0 , respectively to Mr. Pursglove. Effective September 1, 2025, the Company appointed Geordan Pursglove as the Company’s President as the result of the resignation of Bastiaan (“Bas”) van der Baan (see below).

Effective September 1, 2025, the Company entered into an employment agreement with Peter Stazzone to act as the Company’s Chief Financial Officer, for a term of one year, with an annual salary of $150,000. During the three months ended March 31, 2026, the Company paid $37,500 to Mr. Stazzone.

In 2023, the Company entered into an employment agreement with Bas van der Baan to act as the Company’s President, Chief Executive Officer. Effective October 6, 2023, Mr. van der Baan was appointed as Chairman of the Board of Directors. Effective June 16, 2025, the employment agreement was amended to provide that Mr. van der Baan will serve as President and Chief Scientific Officer of the Company. Effective September 1, 2025, Mr. van der Bann resigned as President, but remained as the Company’s Chief Scientific Officer. The term of the employment agreement is for three years and is automatically renewable for additional one-year periods. During the three months ended March 31, 2026 and 2025, the Company paid $40,987 and $37,477, respectively, respectively, to Mr. van der Baan.

Former officers

In 2020, the Company entered into an employment agreement with Robert N. Weingarten to act as the Company’s Vice President and Chief Financial Officer. Mr. Weingarten resigned from the Company on September 1, 2025. During the three months ended March 31, 2025, the Company paid $43,750 to Mr. Weingarten.

In 2024, the Company entered into a consulting agreement with Dr. Jan H.M. Schellens, M.D., Ph.D. the Company engaged Dr. Schellens as a consultant, and, effective August 1, 2024, as the Company’s Chief Medical Officer. The Company pays Dr. Schellens an annual compensation of 104,000 Euros (approximately $108,000 as of December 31, 2025). Effective as of July 31, 2025, the Company agreed to accept the resignation of Dr. Schellens. During the three months ended March 31, 2025, the Company paid $27,504 to Dr. Schellens.

In 2022, René Bernards was appointed to the Company’s Board of Directors as an independent director. and would receive annual compensation for his services on the Board only in the form of cash, in lieu of the annual June 30 grant of stock options as provided to the Company’s other non-officer directors. During the three months ended March 31, 2025, the Company recorded charges of $0. On September 1, 2025 the board accepted his resignation.

Compensatory Arrangements for Members of the Board of Directors

Total cash compensation paid to non-officer directors was $27,500 and $0, respectively, for the three months ended March 31, 2026 and 2025.

Stock-based compensation granted to members of the Company’s Board of Directors, officers and affiliates is described at Note 8.

8. Stock-Based Compensation

The Company periodically issues common stock and stock options as incentive compensation to directors and as compensation for the services of employees, contractors, and consultants of the Company.

Stock Options Issued, Vested and Cancelled

The Company periodically issues stock options as incentive compensation to directors and as compensation for the services of employees, contractors, and consultants of the Company.

As of March 31, 2026, unexpired stock options for 719,309 shares were issued and outstanding under the 2020 Plan and 2,780,691 shares were available for issuance under the 2020 Plan.

During the three months ended March 31, 2026, the Company did not grant any stock options.

On January 20, 2025, the Company granted 16,554 stock options to four non-officer directors of the Company to purchase shares of the Company’s common stock, exercisable for a period of five years at an exercise price of $2.33 per share (the closing market price on the grant date). The grant date fair value of the stock options determined pursuant to the Black-Scholes option-pricing model was determined to be $27,500 and was accrued at December 31, 2024 and charged to operations in 2024. During the three months ended March 31, 2025, there was no expense charged to operations with respect to these stock options.

On March 31, 2025, the Company granted to four non-officer directors of the Company a total of 32,181 stock options to purchase shares of the Company’s common stock, exercisable for a period of five years at an exercise price of $1.21 per share (the closing market price on the grant date). The stock options are exercisable for a period of five years and were immediately vested. The grant date fair value of the stock options determined pursuant to the Black-Scholes option-pricing model was determined to be $27,500, which was charged to operations on March 31, 2025, the date the stock options were fully vested.

The total fair value of options that vested during the three months ended March 31, 2026 and 2025, was $82,176 and $99,738 respectively.

The fair value of a stock option award is calculated on the grant date using the Black-Scholes option-pricing model. The risk-free interest rate is based on the U.S. Treasury yield curve in effect as of the grant date. The expected dividend yield assumption is based on the Company’s expectation of dividend payouts and is assumed to be zero. 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. 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 fair market value of the common stock is determined by reference to the quoted market price of the common stock on the grant date.

For stock options requiring an assessment of value during the three months ended March 31, 2025, the fair value of each stock option award was estimated using the Black-Scholes option-pricing model with the following assumptions:

As of March 31, 2026, 1,148,059 stock options were vested and exercisable. Total deferred compensation expense for the outstanding value of unvested stock options was approximately $230,000 at March 31, 2026, which will be recognized subsequent to March 31, 2026 over a weighted-average period of approximately 9 months.

Based on the closing fair market value of $3.07 per common share on March 31, 2026, the intrinsic value attributed to exercisable but unexercised common stock options was approximately $615,232 at March 31, 2026.

Outstanding stock options to acquire 66,249 shares of the Company’s common stock had not vested at March 31, 2026.

9. Commitments and Contingencies

Legal Claims

The Company may be subject to legal claims and actions from time to time as part of its business activities. As of March 31, 2026 and December 31, 2025, the Company was not subject to any threatened or pending lawsuits, legal claims or legal proceedings.

Principal Commitments

Clinical Trial Agreements

At March 31, 2026, the Company’s remaining financial contractual commitments pursuant to clinical trial agreements and clinical trial monitoring agreements not yet incurred, as described below, aggregated $482,702, including clinical trial agreements of $293,000 and clinical trial monitoring agreements of $189,702, 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.

Netherlands Cancer Institute. In June, 2024, the Company entered into a Clinical Trial Agreement with the Netherlands Cancer Institute (“NKI”) 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.

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.

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 March 31, 2026 and 2025, the Company did not incur any costs pursuant to this agreement.

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 March 31, 2026, which is currently scheduled to be incurred through December 31, 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.

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 March 31, 2026 and 2025, the Company incurred costs of $7,742 and $6,638 pursuant to this letter of intent and subsequent work order.