Core Viewpoint - LIXTE Biotechnology Holdings, Inc. has approved a strategic initiative to allocate up to 25% of its treasury to cryptocurrencies, including Bitcoin, reflecting a belief in the long-term potential of digital assets to enhance shareholder value [1][4]. Group 1: Strategic Capital Allocation - The Board of Directors has authorized the allocation of up to 25% of the company's treasury to cryptocurrencies [1]. - The timing and size of cryptocurrency transactions will depend on market conditions and strategic considerations [2]. - The company will hold all cryptocurrency assets with a fully regulated custodian and ensure compliance with financial, legal, and audit regulations [3]. Group 2: Company Overview - LIXTE is a clinical-stage pharmaceutical company focused on developing cancer therapies, with its lead compound, LB-100, showing promise in enhancing chemotherapy and immunotherapy outcomes [4][5]. - The company is engaged in pioneering research in cancer biology, specifically in the area of activation lethality, and has a comprehensive patent portfolio [5]. - Ongoing proof-of-concept clinical trials are being conducted for various cancer types, including Ovarian Clear Cell Carcinoma and Metastatic Colon Cancer [5].

Financial Performance - The Company recorded a net loss of $1,485,228 and used cash in operations of $1,055,968 for the six months ended June 30, 2025[267]. - The Company has no recurring source of revenues and has experienced negative operating cash flows since inception[269]. - For the first half of 2025, patent and licensing legal and filing fees decreased to $73,386 compared to $146,823 in the same period of 2024, a reduction of 50.0%[298]. - For the three months ended June 30, 2025, the Company reported a net loss of $775,673, compared to a net loss of $1,010,919 for the same period in 2024, indicating a decrease in losses of approximately 23.2%[338]. - The Company had no revenues for the six months ended June 30, 2025, consistent with the same period in 2024[339]. - The Company incurred total costs and expenses of $774,809 for the three months ended June 30, 2025, compared to $1,009,156 for the same period in 2024[325]. - The Company incurred a prorated charge of $207,004 for the cost of patients enrolled in the clinical trial, which is included in accounts payable and accrued expenses as of June 30, 2025[374]. - For the six months ended June 30, 2025, the company incurred a net loss of $1,485,228, an improvement from a net loss of $1,982,241 for the same period in 2024[352]. - The company utilized cash of $1,055,968 in operating activities for the six months ended June 30, 2025, compared to $1,608,266 for the same period in 2024[361]. Cash and Funding - As of June 30, 2025, the Company had cash of $887,212 available to fund its operations[267]. - The Company closed a private placement on July 2, 2025, for gross proceeds of $5,050,000 and a registered direct offering on July 8, 2025, for gross proceeds of $1,500,000[259][260]. - The Company estimates that its existing cash resources, along with recent equity financings, will provide sufficient working capital for at least the next 12 months[270]. - The Company expects existing cash resources, along with net proceeds from recent private placements, to fund operations for at least the next 12 months, but additional capital will be needed for product development[357]. - As of June 30, 2025, the company had working capital of $452,630, down from $827,219 at December 31, 2024, reflecting a net decrease of $374,589[354]. Clinical Development - The Company is focusing on the clinical development of LB-100, a specific protein phosphatase inhibitor, which is believed to have significant therapeutic potential for a broad range of cancers[257]. - The Company is currently investigating LB-100 in combination with checkpoint immunotherapy in two clinical trials, collaborating with GSK and Roche[266]. - The Company is focused on the clinical development of LB-100, a protein phosphatase 2A inhibitor, which is currently being tested in clinical trials for Ovarian Clear Cell Carcinoma, Metastatic Colon Cancer, and Advanced Soft Tissue Sarcoma[307]. - LB-100 has demonstrated anti-cancer activity in animal models and is expected to enhance the effectiveness of existing anti-cancer drugs without significantly increasing toxicity[307]. - The Company aims to secure strategic partnerships or licensing agreements with major pharmaceutical companies as it progresses through the FDA-approval process for LB-100[308]. - The Company has ongoing clinical trials for its lead anti-cancer compound LB-100, with various phases actively recruiting patients[365]. - The Phase 1b clinical trial for LB-100 combined with atezolizumab is evaluating safety, optimal dose, and preliminary efficacy for metastatic microsatellite stable colorectal cancer, with a total of 37 patients expected to be enrolled over 24 months[369]. - The clinical trial opened in August 2024, with two patients enrolled to date, and the study has been paused due to two Serious Adverse Events (SAEs) under investigation[370]. - The collaboration with GEIS aims to enroll approximately 150 to 170 patients in a trial assessing LB-100 plus doxorubicin versus doxorubicin alone, with a planned median progression-free survival of 4.5 months for doxorubicin alone and 7.5 months for the combination[377]. - The MD Anderson Cancer Center clinical trial aims to assess the effectiveness of LB-100 combined with GSK's dostarlimab-gxly in treating ovarian clear cell carcinoma, with completion expected by December 31, 2027[386]. Costs and Expenses - Research and development costs for the three months ended June 30, 2025, were $60,648, a decrease of $150,060 or 71.2% compared to $210,708 in 2024[332]. - General and administrative costs for the three months ended June 30, 2025, were $714,161, down by $84,287 or 10.6% from $798,448 in 2024[335]. - Research and development costs decreased by $177,667, or 53.9%, in 2025 compared to 2024, primarily due to a decrease in clinical oversight costs of $80,507 and preclinical research costs of $138,947[345]. - General and administrative costs decreased by $316,619, or 19.2%, in 2025 compared to 2024, mainly due to reductions in insurance expenses of $125,174 and officer compensation costs of $191,878[349]. - The Company incurred costs of $14,794 and $60,569 for the six months ended June 30, 2025 and 2024, respectively, under the License Agreement[408]. - The Company incurred costs of $34,857 and $9,870 under a contract with MRI Global for stability analysis during the six months ended June 30, 2025 and 2024, respectively[419]. Regulatory and Compliance - The Company received notice from Nasdaq on July 15, 2025, that it was in compliance with the Stockholders' Equity Requirement after recent equity financings[283]. - The Company’s independent registered public accounting firm expressed substantial doubt about its ability to continue as a going concern due to ongoing cash requirements[272]. - The Company has not commenced any revenue-generating operations and is dependent on raising equity capital to fund its operating requirements as of June 30, 2025[323]. - The Company has adopted ASU 2023-07 for segment reporting, which requires additional disclosures effective January 1, 2024[291]. - The Company is evaluating various strategic alternatives, including merger or acquisition opportunities, to obtain capital for operations and maintain its Nasdaq listing[421]. Commitments and Agreements - The Company's remaining financial contractual commitments pursuant to clinical trial agreements not yet incurred aggregate approximately $524,000, scheduled to be incurred through December 31, 2027[268]. - The Company has incurred charges of $685,107 for work done under the GEIS agreement through the fourth milestone as of June 30, 2025[383]. - The aggregate commitment for the Phase 1b portion of the GEIS trial totaled approximately $293,000 as of June 30, 2025, scheduled to be incurred through December 31, 2025[384]. - The Company has a commitment of approximately $1,765,000 under the License Agreement, expected to be incurred over the next twenty years[408]. - The Company's aggregate commitment under the MRI Global contract totaled approximately $90,000 as of June 30, 2025[420].

Core Viewpoint - LIXTE Biotechnology Holdings, Inc. has regained compliance with Nasdaq's Listing Rule 5550(b)(1) after successfully closing a $5.0 million placement and a $1.5 million registered direct offering, ensuring its continued listing on the Nasdaq Capital Market [1][2]. Company Overview - LIXTE is a clinical-stage pharmaceutical company focused on developing and commercializing cancer therapies, particularly targeting new areas in cancer drug development [3][4]. - The company's lead clinical compound, LB-100, is a first-in-class PP2A inhibitor that has shown promise in enhancing chemotherapies and immunotherapies for cancer patients [3][4]. Financial Health - The recent capital raises of $5.0 million and $1.5 million have bolstered the company's financial position, allowing it to meet the minimum equity requirement of $2.5 million for Nasdaq compliance [1][2]. - CEO Geordan Pursglove emphasized the company's commitment to maintaining its Nasdaq listing and improving its financial health while pursuing clinical trials for various cancers [3]. Clinical Development - LIXTE is currently conducting proof-of-concept clinical trials for ovarian clear cell carcinoma, metastatic colon cancer, and advanced soft tissue sarcoma [4]. - The company is pioneering a new treatment paradigm in cancer biology known as activation lethality, supported by a comprehensive patent portfolio [4].

Core Insights - Spartan Capital Securities, LLC announced the closing of a $1.5 million registered direct offering for Lixte Biotechnology Holdings, Inc. [1] - The offering involved the sale of 974,026 shares of Common Stock at a public offering price of $1.54 per share [2] - The gross proceeds of approximately $1.5 million will be used for general corporate purposes and working capital [3] Company Overview - Lixte Biotechnology Holdings, Inc. is a clinical-stage pharmaceutical company focused on cancer drug development [2][8] - The company's lead compound, LB-100, is a first-in-class PP2A inhibitor that enhances the effectiveness of chemotherapy and immunotherapy [8] - Clinical trials are currently underway for Ovarian Clear Cell Carcinoma, Metastatic Colon Cancer, and Advanced Soft Tissue Sarcoma [8] Transaction Details - The offering was made under an effective shelf registration statement previously filed with the U.S. Securities and Exchange Commission [5] - Spartan Capital Securities served as the exclusive placement agent for this transaction [1][4] - The transaction reflects a focus on aligning innovative biotech companies with strategic capital for advancing therapies [4]

Core Insights - LIXTE Biotechnology Holdings, Inc. announced that findings published in the journal Nature validate its ongoing clinical trials with the proprietary compound LB100 for Ovarian and Colorectal cancers [1][2] Group 1: Clinical Trials and Research Findings - A study led by Dr. Amir Jazaeri found that Ovarian Clear Cell Carcinoma (OCCC) patients with inactivating mutations in PPP2R1A had significantly better overall survival when treated with immune checkpoint blockade therapy [2][3] - Inactivating mutations in PPP2R1A reduce the enzymatic activity of PP2A, which is the target of LIXTE's LB-100, and these tumors showed increased interferon gamma response pathways associated with improved immune checkpoint responses [3] - LIXTE is conducting two clinical trials to investigate LB-100's activity in combination with checkpoint immunotherapy, one in collaboration with GSK for OCCC and another with Roche for colon cancer patients [4][5] Group 2: Company Overview and Future Directions - LIXTE is focused on developing new cancer therapies and has demonstrated that LB-100 is well-tolerated in cancer patients at doses associated with anti-cancer activity [6][7] - The company is pioneering 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 successfully closed a registered direct offering, raising approximately $1.5 million through the sale of shares of Common Stock and Pre-Funded Warrants [1][3]. Group 1: Offering Details - The offering included the sale of 974,026 shares of Common Stock or Pre-Funded Warrants, with a public offering price of $1.54 per share [2]. - The Pre-Funded Warrants are immediately exercisable and can be exercised at any time until fully exercised [2]. - The gross proceeds from the transaction amounted to approximately $1.5 million, and the transaction closed on July 8, 2025 [3]. Group 2: Use of Proceeds - The net proceeds from the offering, along with existing cash, are expected to be used 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 clinical compound, LB-100, which has shown potential in enhancing chemotherapies and immunotherapies [6][7]. - LB-100 is part of a new treatment paradigm in cancer biology known as activation lethality, and proof-of-concept clinical trials are currently underway for various cancer types [7].

Group 1: Transaction Overview - Spartan Capital Securities, LLC closed a $5.0 million private placement for Lixte Biotechnology Holdings, Inc. on July 2, 2025, serving as the exclusive placement agent [1][2]. - The offering included the sale of Common Stock (or Pre-Funded Warrants), Series B Convertible Preferred Stock, and Common Warrants to accredited investors [2]. - The company received gross proceeds of approximately $5.0 million, with $4.0 million received at closing and the remaining $1.0 million to be received upon effectiveness of a resale registration statement [3]. Group 2: Use of Proceeds - Proceeds from the offering will be used for general corporate purposes and working capital [3]. Group 3: Company Background - Lixte Biotechnology Holdings, Inc. is a clinical-stage pharmaceutical company focused on developing cancer therapies based on novel biological pathways [8]. - The company's lead compound, LB-100, is a first-in-class PP2A inhibitor that has shown promise in enhancing the effectiveness of chemotherapy and immunotherapy, with clinical trials underway for colon, small cell lung, and sarcoma cancers [8]. Group 4: Representation and Support - Lixte was represented by TroyGould PC, while Spartan Capital Securities was represented by Kaufman & Canoles, P.C. [4].

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)