Core Viewpoint - Lixte Biotechnology Holdings, Inc. has successfully closed a private placement raising approximately $5.0 million through the sale of shares and warrants, aimed at supporting its cancer drug development efforts [1][3]. Group 1: Private Placement Details - The offering included the sale of 2,382,084 shares of Common Stock (or Pre-Funded Warrants), 3,573,130 shares of Series B Convertible Preferred Stock, and 6,355,214 Common Warrants [2]. - The Pre-Funded Warrants are immediately exercisable at a price of $0.00001, while the Common Warrants have an initial exercise price of $1.00 per share and expire 60 months after the resale registration statement is effective [2]. - The gross proceeds of approximately $5.0 million consist of $4.0 million paid at closing and $1.0 million to be paid upon the effectiveness of the resale registration statement [3]. Group 2: Use of Proceeds - The net proceeds from the offering, along with existing cash, are intended for general corporate purposes and working capital [3]. Group 3: Company Overview - Lixte Biotechnology Holdings, Inc. is a clinical-stage pharmaceutical company focused on developing new cancer therapies, particularly its lead compound LB-100, which has shown promise in enhancing chemotherapy and immunotherapy outcomes [6][7]. - LB-100 is part of a new treatment paradigm in cancer biology known as activation lethality, with ongoing proof-of-concept clinical trials for various cancer types [7].

Core Viewpoint - Lixte Biotechnology Holdings, Inc. has entered into a definitive agreement to raise approximately $5.0 million through the sale of shares and warrants, aimed at supporting its cancer drug development efforts [1][3]. Group 1: Offering Details - The offering includes the sale of 2,382,084 shares of Common Stock (or Pre-Funded Warrants), 3,573,130 shares of Series B Convertible Preferred Stock, and 6,355,214 Common Warrants [2]. - The Pre-Funded Warrants are immediately exercisable at a price of $0.00001, while the Common Warrants have an initial exercise price of $1.00 per share and expire 60 months after the resale registration statement is effective [2]. - The gross proceeds are expected to be approximately $5.0 million, with $4.0 million paid at closing and $1.0 million upon the effectiveness of the resale registration statement [3]. Group 2: Use of Proceeds - The net proceeds from the offering, along with existing cash, will be utilized for general corporate purposes and working capital [3]. Group 3: Company Overview - Lixte Biotechnology Holdings, Inc. is a clinical-stage pharmaceutical company focused on developing new cancer therapies, particularly its lead compound LB-100, which has shown promise in enhancing chemotherapy and immunotherapy outcomes [6][7]. - LB-100 is part of a new treatment paradigm in cancer biology known as activation lethality, with ongoing proof-of-concept clinical trials for various cancer types [7].

PART I - FINANCIAL INFORMATION [Condensed Consolidated Financial Statements](index=3&type=section&id=Item%201.%20Condensed%20Consolidated%20Financial%20Statements) Unaudited condensed financial statements show a Q1 **2025** net loss of **$709,555**, an improvement, with cash of **$1,384,697** after a **$914,228** February offering Condensed Consolidated Balance Sheet Data (Unaudited) | | March 31, **2025** | December 31, **2024** | | :--- | :--- | :--- | | **Assets** | | | | Cash | **$1,384,697** | **$1,038,952** | | Total Assets | **$1,514,228** | **$1,145,503** | | **Liabilities & Equity** | | | | Total Current Liabilities | **$355,098** | **$318,284** | | Total Stockholders' Equity | **$1,159,130** | **$827,219** | | Total Liabilities & Stockholders' Equity | **$1,514,228** | **$1,145,503** | Condensed Consolidated Statement of Operations (Unaudited) | | Three Months Ended March 31, **2025** | Three Months Ended March 31, **2024** | | :--- | :--- | :--- | | Revenues | **$0** | **$0** | | Research and development costs | **$91,457** | **$119,064** | | General and administrative costs | **$615,483** | **$847,815** | | Loss from operations | **$(706,940)** | **$(966,879)** | | Net loss | **$(709,555)** | **$(971,322)** | | Net loss per common share | **$(0.29)** | **$(0.43)** | Condensed Consolidated Statement of Cash Flows (Unaudited) | | Three Months Ended March 31, **2025** | Three Months Ended March 31, **2024** | | :--- | :--- | :--- | | Net cash used in operating activities | **$(568,483)** | **$(789,225)** | | Net cash provided by financing activities | **$914,228** | **$0** | | Net increase (decrease) in cash | **$345,745** | **$(789,225)** | | Cash at end of period | **$1,384,697** | **$3,414,263** | [Note 1: Organization and Basis of Presentation](index=8&type=section&id=1.%20Organization%20and%20Basis%20of%20Presentation) Lixte, a clinical-stage biopharmaceutical company, faces going concern doubt with cash only until **September 30, 2025**, and must meet **Nasdaq's** **$2.5 million** equity requirement by **July 3, 2025** - The company's primary focus is the clinical development of a protein phosphatase inhibitor, **LB-100**, for cancer therapy[29](index=29&type=chunk) - Management has substantial doubt about the company's ability to continue as a going concern, with cash resources at **March 31, 2025**, estimated to fund operations only through **September 30, 2025**[43](index=43&type=chunk)[45](index=45&type=chunk) - The company received an extension from **Nasdaq** until **July 3, 2025**, to regain compliance with the minimum stockholders' equity requirement of **$2,500,000** to maintain its listing[37](index=37&type=chunk)[39](index=39&type=chunk) [Note 2: Summary of Significant Accounting Policies](index=10&type=section&id=2.%20Summary%20of%20Significant%20Accounting%20Policies) Key accounting policies include expensing patent costs, recognizing R&D over contract life, valuing stock-based compensation, and classifying all warrants as equity, operating as a single **PP2A** inhibitor development segment - All patent and licensing legal and filing fees are charged to operations as incurred. These costs were **$56,084** for the three months ended **March 31, 2025**[57](index=57&type=chunk) - The company operates in a single reportable segment, which is the development of Protein Phosphatase **2A** inhibitors[48](index=48&type=chunk) - At **March 31, 2025**, all outstanding warrants were classified as equity, and there were no liability-classified warrants[70](index=70&type=chunk) - Potentially dilutive securities, including preferred stock, warrants, and options totaling **2,010,753** potential shares, were excluded from the EPS calculation as their effect would have been anti-dilutive[73](index=73&type=chunk)[74](index=74&type=chunk) [Note 4: Stockholders' Equity](index=17&type=section&id=4.%20Stockholders'%20Equity) The company's equity structure includes a February **2025** offering of **434,784** shares and equal warrants, raising **$914,228** net proceeds, with **2,684,074** common shares and **1,275,758** warrants outstanding - In February **2025**, the company sold **434,784** shares of common stock at **$2.415** per share and issued warrants for an equal number of shares in a registered direct offering and concurrent private placement[104](index=104&type=chunk) - The February **2025** offering generated gross proceeds of **$1,050,003** and net proceeds of **$914,228** after deducting placement agent fees and other costs[106](index=106&type=chunk) Common Stock Warrant Activity | | Number of Shares | Weighted Average Exercise Price | | :--- | :--- | :--- | | Warrants outstanding at Dec 31, **2024** | **808,365** | **$16.407** | | Issued | **467,393** | **$2.341** | | Warrants outstanding at Mar 31, **2025** | **1,275,758** | **$11.254** | [Note 5: Related Party Transactions](index=20&type=section&id=5.%20Related%20Party%20Transactions) Related party costs decreased to **$208,469** in Q1 **2025** from **$317,662** in Q1 **2024** due to lower cash compensation, as the Board approved paying director fees in stock options to preserve cash - To preserve cash, the Board of Directors approved amendments to receive stock options in lieu of cash compensation for services from Q2 **2024** through Q4 **2025**[126](index=126&type=chunk) Related Party Costs | | Three Months Ended March 31, **2025** | Three Months Ended March 31, **2024** | | :--- | :--- | :--- | | Cash-based | **$108,731** | **$214,735** | | Stock-based | **$99,738** | **$102,927** | | **Total** | **$208,469** | **$317,662** | [Note 6: Stock-Based Compensation](index=23&type=section&id=6.%20Stock-Based%20Compensation) Stock-based compensation costs were **$99,738** for Q1 **2025**, nearly flat year-over-year, with **$303,000** of unrecognized expense for unvested options to be recognized over approximately **17** months as of **March 31, 2025** - Total stock-based compensation costs were **$99,738** for Q1 **2025**, compared to **$102,927** for Q1 **2024**[148](index=148&type=chunk) - As of **March 31, 2025**, total deferred compensation expense for unvested stock options was approximately **$303,000**, to be recognized over a weighted-average period of **17** months[148](index=148&type=chunk) - On **March 31, 2025**, non-officer directors were granted **32,181** stock options in lieu of cash compensation for the quarter, with a grant date fair value of **$27,500**[146](index=146&type=chunk) [Note 8: Commitments and Contingencies](index=28&type=section&id=8.%20Commitments%20and%20Contingencies) Financial commitments total **$514,000** for clinical trials through **2027**, with a colorectal cancer trial paused due to Serious Adverse Events (**SAEs**), and long-term commitments exist under an **NIH** license agreement - As of **March 31, 2025**, remaining financial contractual commitments for clinical trial agreements and monitoring totaled approximately **$514,000**, scheduled to be incurred through **2027**[155](index=155&type=chunk) - A Phase **1b** clinical trial of **LB-100** combined with atezolizumab for colorectal cancer, conducted with the Netherlands Cancer Institute, has been paused for enrollment by the Institutional Review Board (**IRB**) due to two Serious Adverse Events (**SAEs**)[160](index=160&type=chunk)[212](index=212&type=chunk) - The company was relieved of the financial obligation to support the randomized Phase **2** portion of its clinical trial with **GEIS** for advanced soft tissue sarcoma, making the continuation of that phase uncertain[172](index=172&type=chunk) - The company has a patent license agreement with the **NIH** that includes future benchmark payments totaling **$1,225,000** and royalty obligations[190](index=190&type=chunk)[194](index=194&type=chunk) [Management's Discussion and Analysis of Financial Condition and Results of Operations](index=38&type=section&id=Item%202.%20Management's%20Discussion%20and%20Analysis%20of%20Financial%20Condition%20and%20Results%20of%20Operations) Management discusses financial condition, highlighting going concern uncertainty, **Nasdaq** compliance, and clinical trial risks, with net loss decreasing to **$709,555** due to reduced expenses, though cash only funds operations through Q3 **2025** [Overview and Recent Developments](index=38&type=section&id=Overview%20and%20Recent%20Developments) The company focuses on its lead **PP2A** inhibitor, **LB-100**, for cancer therapy, with recent preclinical data on its active form and a new study initiated to test its ability to eliminate pre-malignant cells - The company's product pipeline is primarily focused on inhibitors of protein phosphatase **2A** (**PP2A**), with its lead compound being **LB-100**[225](index=225&type=chunk) - New preclinical data was published demonstrating the enzymatic conversion of **LB-100** into its active metabolite, endothall, which may serve as a biomarker to identify responsive patients[227](index=227&type=chunk)[228](index=228&type=chunk) - A new preclinical study with the Netherlands Cancer Institute will investigate whether **LB-100** can eliminate 'initiated' cells with cancer-related mutations, potentially reducing cancer risk[230](index=230&type=chunk)[232](index=232&type=chunk) [Going Concern and Nasdaq Compliance](index=39&type=section&id=Going%20Concern%20and%20Nasdaq%20Compliance) Substantial doubt exists about the company's going concern, with **$1.38 million** cash funding operations only through **September 30, 2025**, and a need to meet **Nasdaq's** **$2.5 million** equity requirement by **July 3, 2025** - Existing cash resources of **$1.38M** are estimated to be sufficient to fund operations only through **September 30, 2025**, raising substantial doubt about the company's ability to continue as a going concern[234](index=234&type=chunk)[239](index=239&type=chunk) - The company has until **July 3, 2025**, to demonstrate compliance with **Nasdaq's** **$2.5 million** minimum stockholders' equity requirement to maintain its listing[247](index=247&type=chunk)[249](index=249&type=chunk) [Results of Operations](index=46&type=section&id=Results%20of%20Operations) This section analyzes Q1 **2025** financial performance, showing a **26.9%** decrease in net loss to **$709,555** from **$971,322** in Q1 **2024**, driven by reduced R&D and G&A expenses Comparison of Operating Results (Three Months Ended March 31) | | **2025** | **2024** | Change (%) | | :--- | :--- | :--- | :--- | | Research and development costs | **$91,457** | **$119,064** | **(23.2%)** | | General and administrative costs | **$615,483** | **$847,815** | **(27.4%)** | | **Net Loss** | **$(709,555)** | **$(971,322)** | **(26.9%)** | - The decrease in R&D costs was mainly due to a **$61,710** reduction in preclinical research focused on developing new anti-cancer compounds[294](index=294&type=chunk) - The decrease in G&A costs was primarily due to lower officer compensation, insurance expense, patent costs, and director fees[298](index=298&type=chunk) [Liquidity and Capital Resources](index=48&type=section&id=Liquidity%20and%20Capital%20Resources) Liquidity depends on equity sales, with working capital increasing to **$1.16 million** due to a **$914,228** February **2025** offering, cash used in operations at **$568,483**, and **$514,000** in clinical trial commitments, with cash only lasting through Q3 **2025** - Working capital increased by **$331,911** during the quarter to **$1,159,130**, mainly due to a registered direct offering[302](index=302&type=chunk) - Net cash provided by financing activities was **$914,228** for the quarter from the sale of securities in February **2025**[310](index=310&type=chunk) - Net cash used in operating activities decreased to **$568,483** in Q1 **2025** from **$789,225** in Q1 **2024**[302](index=302&type=chunk)[309](index=309&type=chunk) - Remaining financial contractual commitments for clinical trials and monitoring totaled **$514,000** as of **March 31, 2025**[308](index=308&type=chunk)[311](index=311&type=chunk) [Quantitative and Qualitative Disclosures About Market Risk](index=58&type=section&id=Item%203.%20Quantitative%20and%20Qualitative%20Disclosures%20About%20Market%20Risk) The company states this section is not applicable, indicating no significant exposure to market risks requiring quantitative and qualitative disclosure - Not applicable[368](index=368&type=chunk) [Controls and Procedures](index=58&type=section&id=Item%204.%20Controls%20and%20Procedures) Management concluded the company's disclosure controls and procedures were effective as of **March 31, 2025**, with no material changes to internal control over financial reporting identified during the quarter - Management concluded that the company's disclosure controls and procedures were effective as of **March 31, 2025**[370](index=370&type=chunk) - No change in the company's internal control over financial reporting occurred during the quarter that has materially affected, or is reasonably likely to materially affect, internal controls[372](index=372&type=chunk) PART II - OTHER INFORMATION [Legal Proceedings](index=59&type=section&id=Item%201.%20Legal%20Proceedings) The company reports it is not currently a party to any pending or threatened legal actions or claims - The Company is not currently subject to any pending or threatened legal actions or claims[374](index=374&type=chunk) [Risk Factors](index=59&type=section&id=Item%201A.%20Risk%20Factors) This section highlights risks including potential **Nasdaq** delisting for failing to meet the **$2.5 million** equity requirement by **July 3, 2025**, and the pause of a colorectal cancer study due to Serious Adverse Events (**SAEs**), which could delay drug development - The company faces a significant risk of being delisted from the **Nasdaq** Capital Market if it cannot regain compliance with the **$2.5 million** minimum stockholders' equity requirement by the extended deadline of **July 3, 2025**[380](index=380&type=chunk)[384](index=384&type=chunk)[386](index=386&type=chunk) - The company's clinical trial for colorectal cancer, testing **LB-100** with atezolizumab, is on hold due to two Serious Adverse Events (**SAEs**). This poses a material risk that could delay or halt the drug's development, increase costs, and negatively impact regulatory approval and future financing[387](index=387&type=chunk)[390](index=390&type=chunk) [Unregistered Sales of Equity Securities and Use of Proceeds](index=61&type=section&id=Item%202.%20Unregistered%20Sales%20of%20Equity%20Securities%20and%20Use%20of%20Proceeds) In February **2025**, the company conducted a private placement of unregistered warrants to purchase **434,784** common shares for investors and **32,609** for the placement agent, relying on Section **4(a)(2)** of the **Securities Act** exemption - In a private placement concurrent with a registered offering in February **2025**, the company issued unregistered warrants to purchase an aggregate of **434,784** shares of common stock[393](index=393&type=chunk) - The placement agent for the offering also received unregistered warrants to purchase **32,609** shares of common stock[395](index=395&type=chunk) - These unregistered sales were conducted in reliance on the exemption from registration requirements afforded by Section **4(a)(2)** of the **Securities Act**[394](index=394&type=chunk) [Defaults Upon Senior Securities](index=61&type=section&id=Item%203.%20Defaults%20Upon%20Senior%20Securities) The company states this section is not applicable - Not applicable[397](index=397&type=chunk) [Mine Safety Disclosures](index=61&type=section&id=Item%204.%20Mine%20Safety%20Disclosures) The company states this section is not applicable - Not applicable[398](index=398&type=chunk) [Other Information](index=61&type=section&id=Item%205.%20Other%20Information) No director or officer adopted or terminated a Rule **10b5-1** trading arrangement during the three months ended **March 31, 2025** - During the quarter, no director or officer adopted or terminated a Rule **10b5-1** trading arrangement[399](index=399&type=chunk) [Exhibits](index=62&type=section&id=Item%206.%20Exhibits) This section lists exhibits filed with the **Form 10-Q**, including officer certifications under **Sarbanes-Oxley** and **Inline XBRL** data files - The report includes required exhibits such as officer certifications under **Sarbanes-Oxley** and **Inline XBRL** documents[400](index=400&type=chunk)

Pre-Clinical Study in Collaboration with Netherlands Cancer Institute is in addition to LIXTE's Ongoing Clinical Trials for Ovarian and Colorectal Cancers PASADENA, Calif., March 31, 2025 (GLOBE NEWSWIRE) -- LIXTE Biotechnology Holdings, Inc. ("LIXTE" or the "Company") (Nasdaq: LIXT and LIXTW), a clinical stage pharmaceutical company, today announced it will conduct a new pre-clinical study in collaboration with Netherlands Cancer Institute (NKI) to test whether "initiated" cells that carry mutations found ...

Core Insights - LIXTE Biotechnology Holdings, Inc. has initiated two new clinical trials in collaboration with MD Anderson and the Netherlands Cancer Institute, focusing on treatments for ovarian and colorectal cancer [1][3] - The company has secured an exclusive patent license agreement with the NIH for LB-100, which aims to enhance cancer immunotherapies [1] - Recent publications in prominent medical journals EMBO and Cancer Discovery support LIXTE's clinical trial program, highlighting the potential of LB-100 in cancer treatment [1][6] Clinical Trials - LIXTE is conducting trials for ovarian cancer at M.D. Anderson Cancer Center and Northwestern University, with support from GSK [2][3] - A colorectal cancer trial is being conducted at the Netherlands Cancer Institute, supported by F. Hoffmann-La Roche [3][6] - The first patient has been dosed in a Phase 1b/2 trial combining LB-100 with GSK's immunotherapy for ovarian clear cell carcinoma [6] Intellectual Property and Research - LIXTE has received a Notice of Allowance from the USPTO for a patent related to the modulation of immune response using LB-100 [6] - Studies published in Cancer Discovery and EMBO indicate that LB-100 can alter cancer cells to enhance their vulnerability to immunotherapy [6] Financial Activities - The company completed a registered direct offering, raising approximately $1,050,000 for working capital and corporate purposes [6]

Clinical Trials and Research - The colorectal study testing LB-100 in combination with atezolizumab has been paused for enrollment due to two Serious Adverse Events (SAEs) observed in the clinical trial launched in August 2024 [44]. - The National Cancer Institute (NCI) initiated a glioblastoma pharmacologic clinical trial in May 2019, with the company providing the LB-100 clinical compound [46]. - LB-100 has shown potential to enhance the effectiveness of standard treatments for glioblastoma, but its ability to penetrate brain tumor tissue remains uncertain [47]. - In a study involving seven patients, LB-100 demonstrated virtually no entry into brain tumor tissue, indicating the need for alternative drug delivery methods [48]. - The company aims to advance LB-100 through Phase 2 clinical trials to evaluate its effectiveness in enhancing existing anti-cancer therapies [75]. - The FDA regulates clinical trials, which are essential for determining the safety and efficacy of new therapies [84]. Intellectual Property - A Patent License Agreement was entered into with the National Institute of Health, focusing on promoting anti-cancer activity in combination with standard anti-cancer drugs [49]. - LB-100 is covered by U.S. patents projected to expire between 2028 and 2034, ensuring protection for its composition and therapeutic uses [63]. - Combination therapies involving LB-100 with other investigational compounds are covered by pending patent applications projected to expire as late as 2043 [66]. - The company relies on a combination of patents, licenses, and trade secrets to protect its intellectual property related to LB-100 and its applications [56]. Financial and Operational Aspects - The company agreed to fund a preclinical study with the Netherlands Cancer Institute at an approximate cost of €391,000 to identify promising drug combinations with LB-100 [53]. - An amendment to the Development Collaboration Agreement extended the research activities and added €500,000 to the operating budget [54]. - The life sciences industry is highly competitive, with major pharmaceutical companies and specialized firms having greater financial and technical resources [77]. - The company relies on outside consultants and advisors for research and development, with only three key personnel as of March 14, 2025 [82]. - The company does not operate or lease any facilities, contracting out research and development activities to commercial laboratories [83]. Regulatory and Legal Environment - Regulatory approvals from the FDA do not guarantee approvals in international markets, complicating commercialization efforts [87]. - The company is not currently subject to any legal claims or proceedings [89]. Cancer Treatment Paradigm - LB-100 series compounds demonstrate anti-cancer activity against a broad spectrum of cancers, including glioblastoma and melanoma, in animal models [73]. - LB-100 is part of a new treatment paradigm in cancer biology, focusing on the hyper-activation of oncogenic signaling to induce cancer cell death [74].

Core Insights - LIXTE Biotechnology Holdings, Inc. announced the publication of new pre-clinical data regarding its lead clinical compound, LB-100, which is converted into the active form endothall, a protein phosphatase (PP2A) inhibitor effective in cancer treatment when combined with immunotherapy [1][4] Group 1: Research Findings - The Netherlands Cancer Institute identified an enzyme that mediates the conversion of LB-100 into endothall, suggesting it could serve as a biomarker to identify patients likely to respond to LB-100 [2] - Research from BioPharmaWorks LLC indicated that LB-100 converts into endothall through hydrolysis, although this process is slow under physiological conditions; the enzymatic conversion identified by the Bernards laboratory accelerates this activation within cells [3] Group 2: Clinical Development - Clinical trials for LB-100 are currently underway targeting ovarian cancer and colorectal cancer, with the new pre-clinical data enhancing understanding of LB-100 and endothall's biological availability in patients, aiding in optimizing patient selection for future trials [4] - LIXTE's LB-100 is positioned as a first-in-class PP2A inhibitor, demonstrating good tolerance in cancer patients at doses linked to anti-cancer activity, with potential to improve outcomes for patients undergoing various therapies [4] Group 3: Company Overview - LIXTE is focused on developing and commercializing cancer therapies, with a comprehensive patent portfolio and no known competitors in its new approach to cancer biology, termed activation lethality [4]

Core Insights - LIXTE Biotechnology Holdings, Inc. announced the online publication of pre-clinical data demonstrating the conversion of its lead compound LB-100 into the active form endothall, which is effective in cancer treatment when combined with immunotherapy [1][4] - The discovery of an enzyme that mediates this conversion could serve as a potential biomarker to identify patients likely to respond to LB-100 [2] - Clinical trials for LB-100 are currently underway for ovarian and colorectal cancer, with the new data aiding in optimizing patient selection for future trials [4] Group 1: Scientific Findings - The Netherlands Cancer Institute identified an enzyme that facilitates the conversion of LB-100 into endothall, suggesting its role as a potential biomarker [2] - Research from BioPharmaWorks LLC indicates that LB-100 converts into endothall through hydrolysis, although this process is slow under physiological conditions [3] Group 2: Company Overview - LIXTE is focused on developing new cancer therapies, with LB-100 being a first-in-class PP2A inhibitor that has shown good tolerance in cancer patients [4] - The company claims that LB-100 has the potential to improve outcomes for patients undergoing various chemotherapies or immunotherapies, supported by a comprehensive patent portfolio [4]

Core Viewpoint - LIXTE Biotechnology Holdings, Inc. has initiated a clinical trial combining its compound LB-100 with GSK's immunotherapy Dostarlimab to treat ovarian clear cell cancer, with the first patient dosed at the Lurie Cancer Center [1][2][3]. Group 1: Clinical Trial Details - The clinical trial is led by Dr. Emily M. Hinchcliff at the Lurie Cancer Center, a National Cancer Institute-designated Comprehensive Cancer Center [2]. - Patient recruitment is currently underway, and the trial aims to assess the effectiveness of combining LB-100 with Dostarlimab in treating ovarian clear cell carcinoma, a condition with significant unmet medical needs [3]. - The trial was initially launched in January 2024 at The University of Texas MD Anderson Cancer Center, directed by Dr. Amir Jazaeri [3]. Group 2: Company Overview - LIXTE is a clinical-stage pharmaceutical company focused on developing new cancer therapies, with its lead compound LB-100 being a first-in-class PP2A inhibitor [4]. - LB-100 has shown potential to improve outcomes for patients undergoing various chemotherapies or immunotherapies, supported by extensive preclinical data [4]. - The company operates in a unique field of cancer biology known as activation lethality, and it holds a comprehensive patent portfolio to protect its innovations [4].

Core Viewpoint - LIXTE Biotechnology Holdings, Inc. has initiated a clinical trial combining its compound LB-100 with GSK's immunotherapy Dostarlimab to treat ovarian clear cell cancer, with the first patient dosed at the Lurie Cancer Center [1][2][3]. Group 1: Clinical Trial Details - The clinical trial is led by Dr. Emily M. Hinchcliff at the Lurie Cancer Center, a National Cancer Institute-designated Comprehensive Cancer Center [2]. - Patient recruitment is currently underway, and the trial aims to assess the effectiveness of combining LB-100 with Dostarlimab in treating ovarian clear cell carcinoma, which has a high unmet medical need [3]. - The trial was initially launched in January 2024 at The University of Texas MD Anderson Cancer Center, directed by Dr. Amir Jazaeri [3]. Group 2: Company Overview - LIXTE is a clinical-stage pharmaceutical company focused on developing new cancer therapies, with its lead compound LB-100 being a first-in-class PP2A inhibitor [4]. - LB-100 has shown potential to improve outcomes for patients undergoing various chemotherapies or immunotherapies, supported by extensive preclinical data [4]. - The company operates in a unique field of cancer biology known as activation lethality, with a comprehensive patent portfolio protecting its innovations [4].