Financial Performance - For the nine months ended September 30, 2023, the Company recorded a net loss of $4,054,774 and used cash in operations of $3,391,142[215]. - As of September 30, 2023, the Company had no revenue-generating operations and is dependent on raising equity capital to fund its operating requirements[256]. - The Company reported a net loss of $(1,018,760) for the three months ended September 30, 2023, with a net loss per common share of $(0.49)[257]. - The Company incurred a net loss of $1,018,760 for the three months ended September 30, 2023, compared to a net loss of $1,478,009 for the same period in 2022[269]. - For the nine months ended September 30, 2023, the Company had a net loss of $4,054,774, an improvement from a net loss of $4,681,231 in 2022[282]. - Interest income for the nine months ended September 30, 2023 was $13,538, up from $4,211 in 2022, indicating improved investment returns[280]. Cash and Capital Requirements - As of September 30, 2023, the Company had cash of $5,105,611 available to fund its operations[215]. - The Company estimates that it will need to raise additional capital by mid-2024 to manage its current business plan during the remainder of 2024 and 2025[219]. - The Company has experienced negative operating cash flows since inception and relies on equity capital to fund operations[210]. - The Company estimates it will need to raise additional capital by mid-2024 to continue its operations and clinical trial programs[285]. - The Company had cash of $5,105,611 available to fund operations as of September 30, 2023, reflecting a decrease in working capital from $5,165,227 at December 31, 2022[283]. Clinical Development and Research - The Company is focused on the clinical development of LB-100, a specific protein phosphatase inhibitor with demonstrated anti-cancer activity[209]. - A Phase 1b/2 clinical trial is underway to assess the effectiveness of LB-100 in combination with GSK's dostarlimab for treating ovarian clear cell carcinoma[213]. - The Company completed a Phase 1 clinical trial of LB-100, showing antitumor activity with responses lasting up to 11 months in pancreatic cancer patients[250]. - The LB-100 series of drugs is believed to have a different mechanism of action compared to currently approved cancer agents, showing activity against various cancers in pre-clinical models[244]. - The Company is not planning to further develop the LB-200 series of drugs, focusing instead on the clinical development of LB-100[247]. - Research and development costs for the three months ended September 30, 2023, were $132,487, focused on developing additional novel anti-cancer compounds[262]. - For the three months ended September 30, 2023, research and development costs were $272,388, a decrease of $139,901 or 51.4% compared to the same period in 2022[266]. - For the nine months ended September 30, 2023, research and development costs were $749,029, down from $895,649 in 2022, reflecting a decrease of $146,620 or 16.4%[279]. Costs and Expenses - For the three months ended September 30, 2023, total costs and expenses were $1,024,181, resulting in a loss from operations of $(1,024,181)[257]. - General and administrative costs decreased by $314,419, or 26.1%, from $1,206,113 in 2022 to $891,694 in 2023, primarily due to a reduction in stock option expenses[261]. - General and administrative costs for the nine months ended September 30, 2023 were $3,315,297, a decrease of $467,917 or 12.4% compared to $3,783,214 in 2022[274]. Contractual Commitments - The Company has significant contractual commitments of approximately $6,262,000 related to clinical trial agreements scheduled through December 31, 2027[215]. - Remaining contractual commitments for clinical trial agreements not yet incurred totaled $6,262,000, scheduled to be incurred through approximately December 31, 2027[290]. - The Company entered into Amendment No. 2 to the Development Collaboration Agreement with the Netherlands Cancer Institute, adding €250,000 (approximately $263,000) to the operating budget[265]. - The aggregate commitment under the GEIS agreement, less amounts previously paid, totaled approximately $3,423,000 as of September 30, 2023[305]. - The aggregate commitment under the City of Hope agreement totaled approximately $2,433,000 as of September 30, 2023, expected to be incurred through March 31, 2026[310]. - The aggregate annual cash compensation for all officers increased to $950,000 effective September 26, 2023, and will decrease to $700,000 following the death of Dr. Kovach on October 5, 2023[331]. Strategic Decisions and Future Outlook - The Company has decided not to pursue further studies in myelodysplastic syndrome (MDS) due to other available opportunities[296]. - There is no assurance that the Company's pharmaceutical compounds will achieve regulatory approvals and market acceptance for sustainable revenues[341]. - The Company may need to reduce or discontinue its research and development programs if cash resources are insufficient[341]. - The Company is not currently aware of any trends or events that could materially affect its financial condition in the near term[342].

Financial Position - The Company has cash of $2,912,920 available to fund its operations as of June 30, 2023[211]. - The Company raised approximately $3,500,000 in gross proceeds from a registered direct offering and a concurrent private placement on July 20, 2023[209]. - The Company has remaining contractual commitments of $6,389,000 related to clinical trial agreements scheduled to be incurred through approximately December 31, 2025[211]. - The Company estimates that existing cash resources will fund its current clinical trial program through approximately December 31, 2024[215]. - The Company experienced negative operating cash flows since inception and has substantial doubt about its ability to continue as a going concern within one year[213]. - As of June 30, 2023, the company had working capital of $2,692,534, down from $5,165,227 at December 31, 2022, reflecting a decrease of $2,472,693[277]. - The company estimates it will need to raise additional capital to fund operations, including clinical trial commitments, during the latter half of the fiscal year ending December 31, 2024[279]. Revenue and Expenses - The Company has not yet commenced any revenue-generating operations and relies on equity capital to fund its operating requirements[200]. - The Company did not generate any revenues for the three months ended June 30, 2023 and 2022[254]. - General and administrative costs for Q2 2023 were $1,242,541, a decrease of $138,659 or 10.0% compared to Q2 2022[257]. - Research and development costs for Q2 2023 were $427,457, primarily for clinical oversight and pre-clinical research[258]. - The Company reported a net loss of $1,668,355 for Q2 2023, compared to a net loss of $1,546,304 for Q2 2022[253]. - The total costs and expenses for the six months ended June 30, 2023 were $3,040,145, compared to $3,200,362 for the same period in 2022[253]. - General and administrative costs for the six months ended June 30, 2023, were $2,423,603, a decrease of $153,498, or 6.0%, compared to $2,577,101 for the same period in 2022[269]. - The company had interest income of $7,729 for the six months ended June 30, 2023, compared to $300 for the same period in 2022[274]. Clinical Development - The Company is focusing on the clinical development of LB-100, a specific protein phosphatase inhibitor with demonstrated anti-cancer activity[199]. - The Company is focusing on the clinical development of its LB-100 series of drugs, which have shown activity against various cancers[238]. - The Company completed a Phase 1 clinical trial of LB-100, showing antitumor activity in humans with responses lasting up to 11 months[244]. - The Company’s research indicates that LB-100 can turn immunologically "cold" tumors "hot," enhancing the effectiveness of immune checkpoint blockade[204]. - The Company has entered into a collaboration agreement with GEIS for a clinical trial involving LB-100 and doxorubicin, targeting 150 to 170 patients over two years[289]. - The expected median progression-free survival (PFS) is 4.5 months for doxorubicin alone and 7.5 months for the combination with LB-100, aiming for a statistically significant reduction in relative risk of progression or death[290]. - The Company has executed a Clinical Research Support Agreement with City of Hope for a Phase 1b trial of LB-100 in combination with standard treatment for extensive-stage small cell lung cancer, with total costs expected to be approximately $2,433,000[302]. - The clinical trial at City of Hope is expected to enroll between 18 to 30 patients, with a completion date anticipated by December 31, 2024[303]. - The Company finalized a work order agreement with Theradex for a Phase I/II trial of LB-100 plus doxorubicin, with estimated costs of approximately $153,000[305]. - The NCI study aims to determine the extent of LB-100 penetration in recurrent malignant gliomas, with results expected by the end of 2023[309]. Research and Development Costs - Research and development costs for the three months ended June 30, 2023, increased by $262,647, or 159.4%, compared to the same period in 2022, primarily due to an increase in clinical and related oversight costs of $275,898[261]. - For the six months ended June 30, 2023, research and development costs were $616,542, consisting of clinical and related oversight costs of $393,892, regulatory service costs of $7,819, and pre-clinical research costs of $214,831[270]. - The Company incurred costs of $268,829 under the GEIS agreement during the three and six months ended June 30, 2023, compared to $0 in the same periods of 2022[297]. - The Company has incurred total costs of $147,572 under the monitoring agreement with Theradex for the Moffitt clinical trial as of June 30, 2023[311]. - The Company has incurred total costs of $225,924 under the contract with MRI Global as of June 30, 2023[326]. - The Company's aggregate commitment under the contract with MRI Global totaled approximately $100,000 as of June 30, 2023[327]. - The Company has incurred a total of $364,788 under the Development Collaboration Agreement with the Netherlands Cancer Institute as of June 30, 2023[325]. Strategic Focus - The Company is not currently planning to allocate resources to further develop its LB-200 series of drugs, focusing instead on LB-100[241]. - The company has decided not to pursue further studies in myelodysplastic syndrome (MDS) and is now focusing on other common diseases, including advanced soft tissue sarcoma and small cell lung cancer[288]. - The Company is facing uncertainties regarding the ability to secure additional financing and the potential need to reduce or discontinue research and development programs[330]. - There are no current trends or events identified that are likely to materially affect the Company's financial condition in the near term[331]. Legal and Licensing - The Company has filed several patents in 2022 related to LB-100, with stable legal and filing costs expected for the remainder of 2023[231]. - The Company entered into an Exclusive License Agreement with Moffitt, obligating it to pay a non-refundable license issue fee of $25,000 after the first patient entered a Phase 1b/2 clinical trial, which began in July 2019[315]. - The Company is required to pay Moffitt earned royalties of 4% on worldwide cumulative net sales of royalty-bearing products, with a minimum royalty payment of $50,000 in the first four years after sales commence[316]. - The Company incurred charges of $53,178 and $48,886 for the Development Collaboration Agreement with the Netherlands Cancer Institute during the three months ended June 30, 2023 and 2022, respectively[325]. - The Company recorded charges of $30,000 for the Collaboration Agreement with BioPharmaWorks for both the three months ended June 30, 2023 and 2022[324]. Compensation - The total aggregate annual compensation for all officers increased to $800,000 effective November 6, 2022, and has continued through June 30, 2023[320].

UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-Q ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended March 31, 2023 ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 Commission file number: 001-39717 LIXTE BIOTECHNOLOGY HOLDINGS, INC. (Exact name of registrant as specified in its charter) (State or other jurisdiction of (I.R.S. Employer incorporation or organization) ...

Financial Position - The Company has cash of $5,353,392 available to fund its operations as of December 31, 2022[318]. - The Company has experienced negative operating cash flows since inception and has financed its working capital requirements through the sale of equity securities[319]. - The Company had working capital of $5,165,227 at December 31, 2022, an increase of $374,889 from $4,790,338 at December 31, 2021, due to the sale of 2,900,000 shares at $2.00 per share[377]. - The Company utilized cash of $4,611,737 in operating activities for the year ended December 31, 2022, compared to $4,142,915 in 2021[381]. - The Company raised $5,141,384 from financing activities in 2022, compared to $3,897,394 in 2021[376]. - The Company expects existing cash resources to fund its clinical trial program through approximately December 31, 2023, but will need to raise additional capital for further development[379]. - The Company has unpaid remaining contractual commitments of $7,892,000 for clinical trial agreements, scheduled to be incurred through December 31, 2025[384]. Clinical Trials and Research - The Company is currently engaged in Phase 2 clinical trials for its lead anti-cancer clinical compound LB-100, which is expected to require significant time and resources to develop[318]. - The Company announced that LB-100 combined with a WEE1 kinase inhibitor showed effective cancer cell killing in three difficult-to-treat cancer types[305]. - The combination therapy of LB-100 and WEE1 inhibition suppressed the growth of patient-derived tumors refractory to conventional therapies with only modest toxicity in animal models[307]. - The Company is recruiting for a clinical trial in patients with previously untreated extensive stage small cell lung cancer, testing LB-100 in combination with chemotherapy and an immune checkpoint blocker[312]. - The Company completed a Phase 1 clinical trial of LB-100, showing antitumor activity with tumor shrinkage lasting 11 months in one pancreatic cancer patient and disease stabilization for 4 months in 9 other patients out of 20[357]. - The Company received FDA approval for a Phase 1b/2 clinical trial of LB-100 in patients with low and intermediate-1 risk MDS, with a total enrollment of 41 patients planned[388]. - The GEIS clinical trial aims to enroll approximately 150 patients over two years, with a median progression-free survival (PFS) of 4.5 months for doxorubicin alone and 7.5 months for doxorubicin plus LB-100[392]. - The Phase 1b clinical trial for small cell lung cancer is expected to enroll 18 to 30 patients, with a target of 24 enrollees, and is anticipated to be completed by December 31, 2024, if additional sites are added[404]. - The NCI study on glioblastoma is designed to assess the penetration of LB-100 into tumor tissue, with results expected in 2023 after five patients have been entered[407]. Financial Performance - The Company reported no revenues for the years ended December 31, 2022, and 2021, and incurred a net loss of $6,312,535 in 2022, compared to a net loss of $6,728,396 in 2021[364][375]. - General and administrative costs for 2022 were $4,962,212, a decrease of $21,457 or 0.4% from 2021, primarily due to a reduction in the fair value of stock options[367][369]. - Research and development costs decreased by $387,507 or 22.3% in 2022, totaling $1,349,269, compared to $1,736,776 in 2021[370][372]. Cost Management - General and administrative costs for 2022 included legal and vendor charges for intellectual property, representing 26.5% of total costs, compared to 14.6% in 2021[331]. - Stock options granted to directors and corporate officers accounted for 30.3% of general and administrative costs in 2022, down from 44.2% in 2021[331]. - Research and development costs for 2022 included charges from four vendors, with the largest representing 21.0% of total costs, while in 2021, the largest vendor represented 30.3%[332]. - Patent and licensing legal and filing fees increased by $539,137, or 73.9%, from $729,171 in 2021 to $1,268,308 in 2022[342]. - The Company expects patent and licensing legal and filing fees to continue increasing in 2023, albeit at a slower rate than in 2022[343]. Strategic Focus - The Company is focusing on the LB-100 series of drugs, which have shown activity against a broad spectrum of cancers in animal models[350]. - LB-100 has demonstrated the potential to enhance the effectiveness of standard anti-cancer drugs without significantly increasing toxicity[356]. - The Company has decided not to actively pursue the pre-clinical development of the LB-200 series of compounds, focusing resources on LB-100 instead[353]. - Collaborations with leading academic research centers have established the efficacy of LB-100 in pre-clinical models of several major cancers[355]. - The Company is focused on securing strategic partnerships or licensing agreements with pharmaceutical companies for cancer programs[358]. Compliance and Regulatory - The Company has received a notification from Nasdaq regarding its failure to maintain a minimum bid price of $1.00 per share, with a compliance period extended to June 19, 2023[313]. - If the Company is unable to secure additional financing, it may need to scale back or discontinue its clinical trial program and other development efforts[324]. Compensation and Agreements - The total aggregate annual compensation for all officers increased to $800,000 effective November 6, 2022[418]. - The Company incurred charges of $204,158 and $55,248 for the Development Collaboration Agreement with the Netherlands Cancer Institute during the years ended December 31, 2022 and 2021, respectively[424]. - The Company has a commitment of approximately $262,000 under the Development Collaboration Agreement with the Netherlands Cancer Institute, expected to be incurred through June 30, 2025[424]. - The Company recorded consulting and advisory fees of $16,000 for the years ended December 31, 2022 and 2021 under the agreement with NDA Consulting Corp[419]. - The Company has incurred costs of $27,702 and $17,782 under the contract with MRI Global during the years ended December 31, 2022 and 2021, respectively[425]. - The Company has agreed to pay FAST five percent (5%) of all proceeds received from the exploitation of study results, up to a maximum of $250,000[422]. - The Company recorded charges of $120,000 for the Collaboration Agreement with BioPharmaWorks for the years ended December 31, 2022 and 2021[421]. - The Company acknowledges that research and development of new pharmaceutical compounds is unpredictable and may affect its cash position and operational sustainability[426].

Financial Position - The Company has cash of $6,561,840 available to fund its operations as of September 30, 2022[193]. - The Company had working capital of $6,411,140 as of September 30, 2022, an increase of $1,620,802 from $4,790,338 at December 31, 2021[253]. - The Company raised $5,141,384 from the sale of 2,900,000 shares of common stock at $2.00 per share in April 2022[253]. - The Company expects existing cash resources to fund its clinical trial program through approximately September 30, 2023, but will need to raise additional capital for further development[255]. - The Company has experienced negative operating cash flows since inception and has substantial doubt about its ability to continue as a going concern[195]. - There are uncertainties regarding the Company's ability to secure additional financing and achieve sustainable revenues[302]. - The Company is not currently aware of any trends or events likely to materially affect its financial condition in the near term[303]. Revenue and Operating Loss - The Company reported no revenues for the three months ended September 30, 2022 and 2021[230]. - The Company incurred a net loss of $1,478,009 for Q3 2022, compared to a net loss of $1,238,724 for Q3 2021[229]. - The Company incurred a net loss of $1,478,009 for the three months ended September 30, 2022, compared to a net loss of $1,238,724 for the same period in 2021[240]. - Net cash used in operating activities for the nine months ended September 30, 2022, was $3,403,289, compared to $2,996,066 for the same period in 2021[258]. Clinical Trials and Development - The Company is engaged in Phase 2 clinical trials, which are expected to take significant time and resources to develop products capable of generating sustainable revenues[193]. - The Spanish Agency for Medicines and Health Products has authorized a Phase 1b/randomized Phase 2 study of LB-100 combined with doxorubicin for advanced soft tissue sarcomas[183]. - The clinical trial is expected to enroll up to 170 patients and be completed within two and a half years[187]. - The Company has developed two series of pharmacologically active drugs, LB-100 and LB-200, targeting various cancers and diseases[213]. - LB-100 has shown antitumor activity in a Phase 1 clinical trial, with tumor shrinkage lasting for 11 months in one pancreatic cancer patient[220]. - The Company intends to focus on the clinical development of LB-100 and its analogs, while maintaining patents for LB-200[217]. - The Company is currently seeking to add two additional centers to increase patient accrual for the clinical trial of LB-100 in small cell lung cancer[277]. - The clinical trial for LB-100 in combination with standard treatment for extensive-stage small cell lung cancer is expected to be completed by December 31, 2024, with a target of 42 enrollees[278]. - The GEIS clinical trial is scheduled to commence in late 2022 or the first quarter of 2023, with completion expected by June 30, 2025, involving up to 170 patients[271]. - The interim analysis of the GEIS clinical trial will be conducted before full patient accrual to assess the potential superiority of LB-100 plus doxorubicin over doxorubicin alone[272]. - The clinical trial initiated by the National Cancer Institute aims to determine the extent to which LB-100 penetrates recurrent malignant gliomas, with five patients already entered[283]. Costs and Expenses - Patent and licensing legal and filing fees increased by $134,049, or 97.8%, to $271,163 for the three months ended September 30, 2022, compared to the same period in 2021[206]. - For the nine months ended September 30, 2022, patent and licensing legal and filing fees rose by $579,323, or 158.5%, totaling $944,789 compared to $365,466 in 2021[206]. - General and administrative costs for Q3 2022 were $1,206,113, an increase of $195,574 or 19.4% compared to Q3 2021[233]. - Research and development costs for Q3 2022 were $272,388, reflecting an increase of $45,207 or 19.9% compared to Q3 2021[236]. - General and administrative costs for the nine months ended September 30, 2022, were $3,783,214, an increase of $20,841 or 1.0% compared to $3,762,373 in 2021[242][244]. - Research and development costs decreased by $37,473, or 4.0%, in 2022 to $895,649 compared to $933,122 in 2021[245][247]. - The Company incurred consulting and advisory fees of $4,000 for the three months ended September 30, 2022, related to the agreement with NDA Consulting Corp[294]. - Charges to operations under the Collaboration Agreement with BioPharmaWorks were $30,000 for the three months ended September 30, 2022[296]. - The Company incurred charges of $46,068 for the Development Collaboration Agreement with the Netherlands Cancer Institute during the three months ended September 30, 2022[298]. - The total costs incurred under the MRI Global contract amounted to $212,778 as of September 30, 2022[299]. Intellectual Property and Agreements - The Company has engaged a new patent law firm to maximize its intellectual property protection, resulting in increased patent-related costs[207]. - The Company is obligated to pay Moffitt earned royalties of 4% on worldwide cumulative net sales of royalty-bearing products, with a minimum payment of $50,000 in the first four years and $100,000 in year five and thereafter[290]. - The Company has agreed to make milestone payments to INSERM aggregating up to $1,750,000 upon achievement of development milestones and up to $6,500,000 upon achievement of commercial milestones[288]. - The Company recorded charges to operations of $18,699 and $18,698 for the nine months ended September 30, 2022 and 2021, respectively, under the License Agreement with Moffitt[289]. - The Company has agreed to pay FAST 5% of all proceeds from the exploitation of LB-100 study results, up to a maximum of $250,000[297].

UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-Q ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended June 30, 2022 ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 Commission file number: 001-39717 LIXTE BIOTECHNOLOGY HOLDINGS, INC. (Exact name of registrant as specified in its charter) (State or other jurisdiction of (I.R.S. Employer incorporation or organization) ...

Financial Performance - The Company incurred a net loss of $1,656,918 for the three months ended March 31, 2022, compared to a net loss of $1,727,144 for the same period in 2021[204]. - The Company reported no revenues for the three months ended March 31, 2022, and 2021[194]. - Operating activities for the three months ended March 31, 2022, utilized cash of $1,035,097, compared to $1,026,337 for the same period in 2021[211]. - As of March 31, 2022, the Company had working capital of $3,462,186, down from $4,790,338 at December 31, 2021, reflecting a decrease of $1,328,152[206]. - The Company had cash of $3,777,742 available to fund operations as of March 31, 2022[206]. Research and Development - The Company is focused on developing two classes of drugs for cancer treatment, including protein phosphatase inhibitors (LB-100 series) and histone deacetylase inhibitors (LB-200 series), with broad therapeutic potential[150]. - The Company is engaged in Phase 2 clinical trials, which are expected to require significant time and resources before any product can generate sustainable revenues[159]. - The Company completed a Phase 1 clinical trial of LB-100, showing antitumor activity in humans with responses lasting up to 11 months[185]. - The LB-100 series is designed to target various cancers and has shown potential to enhance the effectiveness of existing anti-cancer drugs without increasing toxicity[178]. - The Company has not yet advanced the LB-200 series to clinical stage due to a focus on LB-100 and the need for additional capital[181]. Clinical Trials and Collaborations - The collaboration with the Netherlands Cancer Institute and Oncode Institute has led to a joint patent application for LB-100 combination therapy, indicating progress in research and development efforts[152]. - The Company has entered into a Development Collaboration Agreement with the Netherlands Cancer Institute and Oncode Institute to identify promising drug combinations with LB-100, with an expected duration of approximately two years[249]. - The clinical trial for LB-100 in combination with standard treatment for extensive-stage small cell lung cancer is expected to be completed by June 30, 2024[229]. - The estimated costs for the Phase 1b/2 clinical trial with Theradex are approximately $954,000, with 94% allocated for services and 6% for pass-through costs[236]. - The Company has committed to pay INSERM up to $1,750,000 upon achieving development milestones and up to $6,500,000 upon achieving commercial milestones related to the exploitation of a patent[238]. Costs and Expenses - The Company reported a significant increase in patent and licensing legal and filing fees, totaling $315,237 for the three months ended March 31, 2022, compared to $120,160 in the same period of 2021, representing a 162.3% increase[171]. - General and administrative costs decreased by $85,752, or 6.7%, in 2022 compared to 2021, primarily due to a reduction in stock option compensation[197]. - Research and development costs increased by $14,924, or 3.4%, in 2022 compared to 2021, mainly due to higher contractor costs for LB-100 synthesis[200]. - The Company incurred costs of $292,293 for the preparation of a new batch of clinical LB-100 during the three months ended March 31, 2022[226]. - The Company has recorded charges of $54,230 related to the collaboration agreement with the Netherlands Cancer Institute during the three months ended March 31, 2022[249]. Future Outlook and Risks - The Company has not provided assurances that its forward-looking statements regarding product development and market potential will prove correct, highlighting inherent risks and uncertainties[150]. - The Company faces uncertainties regarding the regulatory approvals and market acceptance of its pharmaceutical compounds, which may impact sustainable revenue generation[252]. - There are no assurances that the Company will achieve operating profitability or positive operating cash flows, even if revenues are generated[252]. - The Company may need to reduce or discontinue its research and development programs if cash resources are insufficient to meet ongoing cash requirements[252]. - Future trends or events may develop that could have a material effect on the Company's financial condition[253]. Equity and Funding - The Company completed the sale of 2,900,000 shares of common stock at a price of $2.00 per share, generating gross proceeds of $5,800,000, with net proceeds of approximately $5,166,160 after costs[158]. - The Company estimates that existing cash resources and proceeds from the equity offering will fund its clinical trial program for approximately 18 months, through September 30, 2023[209]. - As of March 31, 2022, the Company's contractual commitments for clinical trials totaled $8,399,000, scheduled to be incurred through December 31, 2025[214]. - The Company has paid GEIS an aggregate of $67,582 towards the second milestone payment for the clinical trial agreement as of March 31, 2022[223]. - The Company utilized cash of $0 for the GEIS agreement during the three months ended March 31, 2022, compared to $24,171 for the same period in 2021[224].

Financial Position and Funding - As of December 31, 2021, the Company had cash of $4,823,745 available to fund its operations, indicating reliance on equity capital for operational funding [285]. - The Company had no revenues for the years ended December 31, 2021 and 2020, and remains dependent on raising equity capital for operations [327]. - As of December 31, 2021, the Company had working capital of $4,790,338, a decrease of $221,613 from $5,011,951 at the end of 2020 [338]. - The Company raised net cash proceeds of $4,591,349 from a public offering completed on November 30, 2020, and $3,689,761 from a registered direct equity offering on March 2, 2021 [340]. - The Company faces uncertainty regarding its ability to secure additional financing, which may impact its clinical trial schedule and operations [342]. Operating Losses and Costs - The Company reported a net loss of $6,728,396 for the year ended December 31, 2021, compared to a net loss of $3,264,882 for 2020, reflecting an increase in losses of 106.5% [336]. - General and administrative costs increased by $2,940,905, or 144.0%, in 2021 compared to 2020, primarily due to higher stock option expenses and other operational costs [330]. - Research and development costs rose by $513,100, or 41.9%, in 2021, driven by increased contractor costs and clinical oversight expenses [333]. - Stock-based compensation represented 44.2% of total general and administrative costs in 2021, highlighting the Company's reliance on equity awards for employee compensation [294]. Clinical Trials and Research Development - The Company is engaged in Phase 2 clinical trials, which are expected to require significant time and resources before generating sustainable revenues [285]. - The Company completed a Phase 1 clinical trial of LB-100, showing tumor shrinkage lasting for 11 months in one pancreatic cancer patient and stabilization in 9 other solid tumors [319]. - The LB-100 series has demonstrated activity against a broad spectrum of human cancers in pre-clinical models, with a focus on clinical development [314]. - The collaboration with the Netherlands Cancer Institute and Oncode Institute has led to a joint patent application for LB-100 combination therapy, indicating potential for strong synergistic effects in cancer treatment [284]. - The clinical trial initiated with City of Hope is expected to be completed by June 30, 2024, with an aggregate commitment of approximately $2,433,000 as of December 31, 2021 [364]. - The clinical trial for glioblastoma initiated by the National Cancer Institute involves a planned study of eight patients, with the first two enrolled in late 2019 [365]. Regulatory and Market Risks - The company cannot assure that its pharmaceutical compounds will obtain regulatory approvals and market acceptance to achieve sustainable revenues [387]. - There is no assurance that the company will achieve operating profitability or positive operating cash flows [387]. - The company may need to reduce or discontinue research and development programs if cash resources are insufficient [387]. - The company is not currently aware of any trends or events that could materially affect its financial condition in the near term [388]. - New trends or events may develop in the future that could have a material effect on the company's financial condition [388]. - There are no quantitative and qualitative disclosures about market risk applicable to the company [389]. Legal and Patent Costs - Patent and licensing legal and filing fees increased by $175,998 (31.8%) from $553,173 in 2020 to $729,171 in 2021 due to new patent filings and legal services [303]. - The Company expects patent and licensing legal and filing fees to remain stable in 2022 as it focuses on obtaining clinical data for its cancer treatment approach [304]. - The Company has contractual commitments totaling $8,646,000 for clinical trial agreements scheduled through December 31, 2025 [346]. - The aggregate commitment for the collaboration agreement with GEIS is approximately $4,250,000 as of December 31, 2021, expected to be incurred through December 31, 2025 [357]. - The Company has agreed to make milestone payments to INSERM totaling up to $1,750,000 upon achieving development milestones related to LB-100 [372].

UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-Q ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended September 30, 2021 ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 Commission file number: 001-39717 LIXTE BIOTECHNOLOGY HOLDINGS, INC. (Exact name of registrant as specified in its charter) (State or other jurisdiction of (I.R.S. Employer incorporation or organizat ...

UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-Q ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended June 30, 2021 ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 Commission file number: 001-39717 LIXTE BIOTECHNOLOGY HOLDINGS, INC. (Exact name of registrant as specified in its charter) (State or other jurisdiction of (I.R.S. Employer incorporation or organization) ...