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) ...

UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 Commission file number: 000-51476 LIXTE BIOTECHNOLOGY HOLDINGS, INC. (Exact name of registrant as specified in its charter) FORM 10-Q [X] QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended March 31, 2021 [ ] TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 (State or other jurisdiction of (I.R.S. Employer incorporation or organizat ...

Financial Performance - The Company reported no revenues for the years ended December 31, 2020, and 2019[304]. - The net loss for the year ended December 31, 2020, was $3,264,882, compared to a net loss of $2,440,343 for 2019[313]. - Operating activities utilized cash of $2,131,414 for the year ended December 31, 2020, compared to $1,674,148 for 2019[319]. - The Company had working capital of $5,011,951 at December 31, 2020, an increase of $2,577,816 from the previous year[314]. - General and administrative costs increased by $373,604 or 22.4% in 2020 compared to 2019, totaling $2,042,764[307]. - Research and development costs rose by $402,770 in 2020 compared to 2019, amounting to $1,223,676[310]. Funding and Capital - The Company completed the sale of 1,133,102 shares of common stock at a price of $3.70 per share, generating gross proceeds of $4,192,477 and net proceeds of approximately $3,690,030 after cash costs of about $502,447[265]. - The Company completed a public offering in November 2020, generating net cash proceeds of $4,591,349 to fund research and development activities[314]. - The Company is dependent on its ability to raise additional equity capital to fund its research and development activities and achieve sustainable revenues[315]. - The Company has expressed uncertainties regarding the ability to secure additional financing and the potential need to reduce or discontinue research and development programs[359]. Research and Development - The Company has not commenced any revenue-generating operations and has experienced negative operating cash flows since inception, relying on equity capital to fund operations[263][267]. - The Company is focused on the clinical development of the LB-100 series, which has shown activity against a broad spectrum of human cancers in cell culture and animal models[290][292]. - The LB-200 series contains compounds that may be effective for treating chronic hereditary diseases and cancer, but further development is currently on hold due to funding constraints[293]. - The Company has developed two series of pharmacologically active drugs, LB-100 and LB-200, with potential therapeutic applications in cancer and other diseases[290][291]. - The Company intends to maintain composition of matter patents for LB-200 but will not actively pursue its pre-clinical development at this time[293]. Clinical Trials - 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 planned enrollment of 41 patients[322]. - The clinical trial for LB-100 combined with doxorubicin in advanced soft tissue sarcoma aims to enroll approximately 150 patients over two years, with a median progression-free survival of 4.5 months for doxorubicin alone and 7.5 months for the combination[326]. - The Phase 1b clinical trial of LB-100 combined with a standard regimen for extensive stage small cell lung cancer is estimated to cost between $2,500,000 and $2,900,000[335]. - The Company incurred total costs of $130,882 related to the GEIS clinical trial agreement as of December 31, 2020[329]. - The aggregate commitments for clinical trial agreements totaled approximately $5,230,000 as of December 31, 2020, with $4,614,000 related to the GEIS trial[330]. - The estimated cost for new inventory of LB-100 for the GEIS clinical trial is between $600,000 and $700,000, with remaining commitments of approximately $300,000 as of December 31, 2020[332]. - The clinical trial monitoring agreement with Theradex is estimated to cost approximately $954,000, with total costs incurred of $75,788 as of December 31, 2020[338]. Agreements and Obligations - The Company has a Patent Assignment Agreement with INSERM, with potential milestone payments totaling up to $8,250,000 upon achieving development and commercial milestones[341]. - The consulting agreement with Liberi Life Sciences Consultancy BV included a one-time retainer of €15,000 (approximately $18,348) and 2.5% of net payments from sales or licensing activities[343]. - 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 is entered into a Phase 1b/2 clinical trial[344]. - 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[345]. - The Company recorded charges to operations of $25,001 and $80,669 for the years ended December 31, 2020 and 2019, respectively, related to the License Agreement[344]. - The Company incurred charges for salary in the amount of $62,500 for Dr. John Kovach's employment agreement during the year ended December 31, 2020[347]. - The Company recorded charges to operations of $131,650 under the Collaboration Agreement with BioPharmaWorks for the years ended December 31, 2020 and 2019[354]. - The Company agreed to pay FAST 5% of all proceeds received from the exploitation of study results, up to a maximum of $250,000, related to the preclinical studies of LB-100[355]. - The Company incurred charges for salary in the amount of $30,000 for Eric Forman's employment agreement during the year ended December 31, 2020[348]. - The Company has no off-balance sheet arrangements as of December 31, 2020[357]. - The Company recorded consulting and advisory fees of $16,000 and $62,000 for the years ended December 31, 2020 and 2019, respectively, under the agreement with NDA Consulting Corp.[352].

UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-Q [ ] TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 (Exact name of registrant as specified in its charter) [X] QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 Commission file number: 000-51476 (State or other jurisdiction of (I.R.S. Employer incorporation or organization) Identification Number) For the quarterly period ended September 30, 2020 LIX ...

Financial Performance - The Company has not commenced any revenue-generating operations and does not have positive cash flows from operations, relying on equity capital to fund its requirements [129]. - As of June 30, 2020, the Company had not generated any revenues and is dependent on raising additional equity capital by early 2021 [134]. - The Company has experienced recurring operating losses and negative operating cash flows since inception, financing its operations primarily through equity securities [132]. - The Company reported no revenues for the three months and six months ended June 30, 2020 and 2019 [160][168]. - The Company incurred a net loss of $373,125 for the three months ended June 30, 2020, an improvement from a net loss of $610,464 in the same period of 2019 [167]. - Working capital decreased by $843,150 to $1,590,985 as of June 30, 2020, compared to $2,434,135 at December 31, 2019 [178]. - The Company utilized cash of $768,682 for operating activities for the six months ended June 30, 2020, compared to $709,056 for the same period in 2019 [183]. - General and administrative costs decreased by $292,320 or 53.4% to $255,443 for the three months ended June 30, 2020, compared to $547,763 in the same period of 2019 [163]. - For the six months ended June 30, 2020, general and administrative costs were $547,928, down from $938,191 in the same period of 2019, a decrease of $390,263 or 41.6% [171]. - Research and development costs increased by $37,823 or 47.2% to $117,946 for the three months ended June 30, 2020, compared to $80,123 in the same period of 2019 [166]. - Research and development costs for the six months ended June 30, 2020, were $212,618, an increase of $84,181 or 65.6% compared to $128,437 in the same period of 2019 [174]. - The Company had cash and cash equivalents of $1,774,332 available to fund operations as of June 30, 2020 [179]. - The Company has substantial doubt about its ability to continue as a going concern within one year of the financial statements being issued [133]. Clinical Development - The Company is focused on developing LB-100, a protein phosphatase 2A inhibitor, which has shown potential anti-cancer activity in initial Phase 1 clinical trials [149]. - The Company is currently engaged in Phase 2 clinical trials and anticipates significant time to develop products capable of generating sustainable revenues [179]. - The Company entered into a Collaboration Agreement with GEIS for a clinical trial involving LB-100 and doxorubicin, aiming to enroll approximately 150 patients over two years [188]. - The clinical trial is now estimated to begin in Q3 2021 and complete by Q3 2024, with an interim analysis expected in June 2023 [190]. - The Company incurred costs of $43,411 related to the GEIS agreement during the three months ended June 30, 2020, with total costs of $130,882 incurred to date [192]. - Aggregate commitments for the clinical trial agreements totaled approximately $4,795,000 as of June 30, 2020, with $4,162,000 related to the GEIS trial [193]. Strategic Partnerships and Agreements - The Company is seeking strategic partnerships or licensing agreements with pharmaceutical companies to support its cancer programs [152]. - The Company has a consulting agreement with Liberi Life Sciences Consultancy BV, which includes a one-time retainer of €15,000 (approximately $18,348) and a 2.5% commission on net payments from sales or licensing activities [198]. - The License Agreement with Moffitt includes a non-refundable license issue fee of $25,000 and milestone payments aggregating $1,897,000 based on clinical and commercial milestones [199]. - The Company is obligated 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 [200]. - As of June 30, 2020, no milestones had been attained under the License Agreement with Moffitt [199]. - The Company entered into employment agreements with key personnel, including Dr. John Kovach with an annual salary of $250,000 and Dr. James Miser with a monthly salary of $12,500 [201][203]. - The Company’s aggregate commitments under the clinical trial monitoring agreement totaled approximately $876,000 as of June 30, 2020, expected to be incurred over the next five years [196]. - The Company entered into a consulting agreement with NDA Consulting Corp. for oncology research and drug development, with quarterly fees of $4,000 since 2014 [204]. - The Collaboration Agreement with BioPharmaWorks commenced on September 14, 2015, with a monthly fee of $10,000, aimed at commercializing products and strengthening the patent portfolio [205]. - Charges recorded under the Collaboration Agreement were $30,000 for Q2 2020 and Q2 2019, and $60,000 for the first half of 2020 compared to $40,000 for the first half of 2019 [206]. - The Collaboration Agreement was suspended from February 1, 2018, to September 13, 2019, and resumed on March 1, 2019 [206]. Market and Operational Risks - The Company anticipates that the COVID-19 pandemic may delay clinical trials by at least three to six months, impacting operational timelines [155]. - As of June 30, 2020, the Company had no off-balance sheet arrangements [207]. - There were no applicable market risks disclosed in the report [208]. - The Board of Directors approved a 1-for-6 reverse stock split of the Company's outstanding shares, pending regulatory approval [131].

Revenue Generation - The Company has not commenced any revenue-generating operations and does not expect to do so in the foreseeable future[110] - The company has not generated any revenues from operations to date and does not expect to do so in the foreseeable future[150] Financial Performance - For the three months ended March 31, 2020, the Company reported a net loss of $383,175, compared to a net loss of $428,736 for the same period in 2019, indicating a decrease in losses of approximately 10.6%[140] - The company incurred a net loss of $383,175 for the three months ended March 31, 2020, an improvement from a net loss of $428,736 for the same period in 2019[149] - Operating activities utilized cash of $414,033 for the three months ended March 31, 2020, compared to $379,408 for the same period in 2019[156] Costs and Expenses - General and administrative costs for the three months ended March 31, 2020, were $292,484, a decrease of 25.1% from $390,428 in the same period of 2019[142] - General and administrative costs decreased by $97,945 or 25.1% in 2020 compared to 2019[144] - Research and development costs increased to $94,673 for the three months ended March 31, 2020, compared to $48,314 in the same period of 2019, representing a 96% increase[140] - Research and development costs increased by $46,359 in 2020 compared to 2019, totaling $94,673 for the three months ended March 31, 2020[148] Capital and Funding - The Company plans to raise additional capital in early 2021 to support its research and development activities[117] - The company expects to raise additional capital in early 2021 to support its operations[155] - Working capital decreased by $383,175 to $2,050,960 as of March 31, 2020, compared to $2,434,135 at December 31, 2019[151] - Cash and cash equivalents available to fund operations were $2,184,831 as of March 31, 2020[152] Clinical Development - The Company is focused on the clinical development of its lead compound LB-100, with plans to conduct a Phase 1b/2 trial in GBM patients[114] - The coronavirus pandemic may delay clinical trials by at least three to six months, impacting the Company's business operations[137] - The Company has two classes of drugs under development for cancer treatment: LB-100 series (protein phosphatase inhibitors) and LB-200 series (histone deacetylase inhibitors)[131] - The Company has not actively pursued the pre-clinical development of the LB-200 series at this time due to a focus on LB-100[133] Clinical Trial Agreements - The company's aggregate commitments for clinical trial agreements totaled approximately $4,806,000 as of March 31, 2020[162] - The company advanced $43,411 to GEIS towards a clinical trial milestone payment during the three months ended March 31, 2020[161] Licensing and Collaboration Agreements - 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 is entered into a Phase 1b/2 clinical trial, which began in July 2019[166] - The Company is required to pay Moffitt annual license maintenance fees of $25,000 starting from the first anniversary of the Effective Date, with additional milestone payments totaling $1,897,000 based on clinical and commercial milestones[166] - The Company recorded operational charges of $6,165 and $15,274 for the three months ended March 31, 2020 and 2019, respectively, related to the License Agreement[166] - The Company will 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[167] - The Collaboration Agreement with BioPharmaWorks includes a monthly fee of $10,000, with charges to operations of $30,000 and $10,000 for the three months ended March 31, 2020 and 2019, respectively[170] Off-Balance Sheet Arrangements - The Company has not recorded any off-balance sheet arrangements as of March 31, 2020[171]

Financial Position - As of December 31, 2019, the Company had cash and cash equivalents of $2,598,864 available to fund its operations[168]. - As of December 31, 2019, the Company had working capital of $2,434,135, a decrease of $1,689,395 from $4,123,530 in 2018[207]. - The Company has substantial doubt about its ability to continue as a going concern within one year of the date of the financial statements being issued[165]. - The Company expects to need to raise additional capital no later than the fourth quarter of 2020[169]. - The Company expects to begin raising additional capital no later than the fourth quarter of 2020[209]. - The aggregate commitments for clinical trial agreements totaled approximately $5,000,000 as of December 31, 2019, expected to be incurred over the next five years[217]. - At December 31, 2019, the Company had no off-balance sheet arrangements[230]. Revenue and Losses - The Company has not yet commenced any revenue-generating operations and does not expect to do so in the foreseeable future[164]. - The Company reported no revenues for the years ended December 31, 2019, and 2018[198]. - The Company incurred a net loss of $2,440,343 for the year ended December 31, 2019, compared to a net loss of $2,133,128 in 2018[205]. - The Company has experienced recurring operating losses and negative operating cash flows since inception, relying on equity capital to fund operations[164]. Research and Development - The Company incurred costs of $87,471 for a clinical trial agreement, which represented 10.7% of total research and development costs for the year ended December 31, 2019[176]. - Research and development costs increased by $780,203 in 2019, totaling $820,906, primarily due to pre-clinical research activities[204]. - The Company is currently engaged in Phase 2 clinical trials for its lead compound LB-100, with significant therapeutic benefits expected against specific human cancers[191]. - The Company has decided not to actively pursue the pre-clinical development of its LB-200 series of compounds at this time[192]. - The Company has allocated resources to expand its patent portfolio as the potential effectiveness of LB-100 has been documented at the clinical trial level[193]. - The Company plans to complete the validation process for LB-100 for treating depressive or stress disorders within three years, contingent on securing additional capital[220]. Agreements and Collaborations - The Company entered into a Clinical Trial Research Agreement with Moffitt Cancer Center for a Phase 1b/2 clinical trial of its lead anti-cancer compound LB-100[215]. - An Exclusive License Agreement with Moffitt requires a non-refundable license issue fee of $25,000 after the first patient enters a Phase 1b/2 clinical trial, which began in April 2019[222]. - The Company is obligated to pay Moffitt milestone payments totaling $1,897,000, subject to a 40% reduction under certain conditions[222]. - The Company recorded operational charges of $80,669 in 2019 related to the License Agreement, compared to $0 in 2018[222]. - The Company will 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 after sales commence[223]. - The Company has a Materials Cooperative Research and Development Agreement (M-CRADA) with the NIH, focusing on anti-cancer activity and neurological research[225]. - The Company agreed to pay $100,000 to the National Cancer Institute for research support, with the second installment of $50,000 canceled in 2018[226]. - Charges to operations under the Collaboration Agreement with BioPharmaWorks were $100,000 in 2019 and $10,000 in 2018, included in research and development costs[229]. Administrative Costs - General and administrative costs decreased by $428,188 or 20.4% in 2019 compared to 2018, totaling $1,669,160[201].