Lixte Biotechnology(LIXT)

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Lixte Biotechnology(LIXT) - 2023 Q1 - Quarterly Report
2023-05-10 12:30
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) ...
Lixte Biotechnology(LIXT) - 2022 Q4 - Annual Report
2023-03-29 12:30
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].
Lixte Biotechnology(LIXT) - 2022 Q3 - Quarterly Report
2022-11-08 13:30
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].
Lixte Biotechnology(LIXT) - 2022 Q2 - Quarterly Report
2022-08-10 12:30
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) ...
Lixte Biotechnology(LIXT) - 2022 Q1 - Quarterly Report
2022-05-11 12:15
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].
Lixte Biotechnology(LIXT) - 2021 Q4 - Annual Report
2022-03-21 12:01
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].
Lixte Biotechnology(LIXT) - 2021 Q3 - Quarterly Report
2021-11-10 13:00
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 ...
Lixte Biotechnology(LIXT) - 2021 Q2 - Quarterly Report
2021-08-10 20:05
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) ...
Lixte Biotechnology(LIXT) - 2021 Q1 - Quarterly Report
2021-05-12 13:00
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 ...
Lixte Biotechnology(LIXT) - 2020 Q4 - Annual Report
2021-03-26 12:00
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].