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].

Financial Performance - The Company has not generated any revenues from operations to date and does not expect to do so in the foreseeable future [114]. - The company reported no revenues for the three months ended September 30, 2019, and 2018 [160]. - The company incurred a net loss of $1,079,072 for the three months ended September 30, 2019, compared to a net loss of $1,033,959 for the same period in 2018 [168]. - The company incurred a net loss of $2,118,272 for the nine months ended September 30, 2019, compared to a net loss of $1,784,539 for the same period in 2018 [177]. - Interest income for the three months ended September 30, 2019, was $13,889, a significant increase from $424 in the same period of 2018 [167]. - The company had interest income of $41,317 for the nine months ended September 30, 2019, compared to $1,547 for the same period in 2018 [176]. Cash and Capital Resources - As of September 30, 2019, the Company had cash and cash equivalents of $2,976,402 available to fund its operations [118]. - As of September 30, 2019, the company had working capital of $2,756,206, a decrease of $1,367,324 from $4,123,530 at December 31, 2018 [179]. - Operating activities utilized cash of $1,296,610 for the nine months ended September 30, 2019, compared to $934,388 for the same period in 2018 [182]. - The company is dependent on raising equity capital to fund its operating requirements, as it has not commenced any revenue-generating operations [156]. - The Company expects to raise additional capital beginning in late 2020 to fund its research and development activities [118]. Research and Development - The Company completed a Phase 1 clinical trial of its lead anti-cancer compound LB-100, showing anti-tumor activity with tumor shrinkage lasting for 11 months in one patient and disease stabilization for 4 months or more in 9 other patients [136]. - The LB-100 series of compounds has potential use in treating not only several types of cancer but also vascular and metabolic diseases [135]. - The LB-200 series of compounds, which are histone deacetylase inhibitors, has demonstrated broad activity against many cancer types and neuroprotective activity but has not yet advanced to the clinical stage [141]. - The Company has established collaborations with leading academic research centers in the U.S., Europe, and Asia to evaluate LB-100 in pre-clinical models of several major cancers [137]. - The company has entered into a Clinical Trial Research Agreement with Moffitt Cancer Center to conduct a Phase 1b/2 clinical trial for LB-100 in patients with low or intermediate-1 risk MDS [150]. - The Phase 1b/2 clinical trial for MDS began in April 2019, with the first patient enrolled in July 2019, and is expected to be completed within two years [150]. - The company is exploring additional clinical trials, including a Phase 1b/2 trial for small cell lung cancer (SCLC) and a trial combining LB-100 with PD-1 inhibitors [152][153]. - Research and development costs increased by $567,148 in 2019 compared to 2018, driven by an increase in the fair value of stock options and contractor costs [166]. - Research and development costs for the nine months ended September 30, 2019, were $699,038, an increase of $628,789 compared to $70,249 for the same period in 2018 [175]. - The company expects to complete the validation process for LB-100 for treating depressive or stress disorders within three years, requiring substantial additional capital [190]. Legal and Administrative Costs - Patent and licensing related legal and filing costs were $372,755 for the three months ended September 30, 2019, compared to $133,985 for the same period in 2018 [128]. - General and administrative costs decreased by $508,569 or 49.3% in 2019 compared to 2018, primarily due to a reduction in the fair value of stock options issued [163]. - Charges recorded under the Collaboration Agreement for the three months ended September 30, 2019, were $30,000, compared to $0 for the same period in 2018 [200]. - For the nine months ended September 30, 2019, charges under the Collaboration Agreement totaled $70,000, up from $10,000 in 2018 [200]. - The company recorded charges of $74,368 for the nine months ended September 30, 2019, in connection with its obligations under the License Agreement with Moffitt [193]. Strategic Partnerships - The company aims to secure strategic partnerships with pharmaceutical companies to support its cancer research and drug development initiatives [154]. - The Company entered into a Materials Cooperative Research and Development Agreement (M-CRADA) with NINDS for four years starting October 18, 2013, focusing on proprietary compounds for anti-cancer activity and neurological conditions [195]. - A Collaboration Agreement with BioPharmaWorks was established on September 14, 2015, with a monthly fee of $10,000, focusing on commercialization and patent portfolio strengthening [199]. - The Company agreed to provide $100,000 funding to the National Cancer Institute for research support, with the first installment of $50,000 paid on July 9, 2017, and the second installment canceled on November 3, 2018 [196]. Going Concern - The Company has experienced recurring operating losses and negative operating cash flows since inception, financing its working capital primarily through the sale of equity securities [114]. - The Company has substantial doubt about its ability to continue as a going concern within one year of the date that the consolidated financial statements are being issued [115]. - As of September 30, 2019, the Company had no off-balance sheet arrangements [201].

Financial Performance - The Company has not generated any revenues from operations to date and does not expect to do so in the foreseeable future [121]. - The Company reported no revenues for both the three and six months ended June 30, 2019 and 2018 [177][185]. - The Company incurred a net loss of $610,464 for the three months ended June 30, 2019, compared to a net loss of $371,420 for the same period in 2018 [184]. - The net loss for the six months ended June 30, 2019 was $1,039,200, compared to a net loss of $750,580 for the same period in 2018 [192]. - General and administrative costs for the three months ended June 30, 2019 were $547,763, an increase of $216,924 or 65.6% compared to $330,839 in 2018 [178][180]. - Research and development costs for the three months ended June 30, 2019 were $80,123, representing a 94.9% increase from $41,106 in 2018 [181][183]. - For the six months ended June 30, 2019, general and administrative costs were $938,191, up 37.0% from $684,909 in 2018 [186][188]. - Research and development costs for the six months ended June 30, 2019 were $128,437, a 92.3% increase from $66,795 in 2018 [189][191]. - The Company had interest income of $27,428 for the six months ended June 30, 2019, compared to $1,124 for the same period in 2018 [192]. - As of June 30, 2019, the Company had working capital of $3,396,224, down from $4,123,530 at December 31, 2018 [194]. Clinical Trials and Research - The Company entered into a clinical trial with Grupo Espanol de Investigacion en Sarcomas to evaluate LB-100 combined with doxorubicin, aiming to enroll approximately 170 patients over two years [125]. - The Company estimates that the clinical trial for LB-100 will be completed and results published by December 2022 [125]. - The National Cancer Institute is conducting a pharmacologic study to determine if LB-100 penetrates the human brain and tumor tissue [124]. - LB-100 showed anti-tumor activity in a Phase 1 clinical trial, with tumor shrinkage lasting for 11 months in one pancreatic cancer patient and disease stabilization for over 4 months in 9 out of 20 patients with progressive solid tumors [153]. - The Company is focusing on demonstrating LB-100's therapeutic benefit in Phase 2 clinical trials, particularly targeting cancers like myelodysplastic syndrome (MDS) and small cell lung cancer (SCLC) [166]. - A Phase 1b/2 clinical trial for LB-100 in patients with del(5q) MDS began in April 2019, with the first patient enrolled in July 2019, expected to complete within two years [167]. - The Company plans to conduct additional Phase 1b/2 trials for SCLC and in combination with PD-1 inhibitors, requiring further financing beyond current budgets [171]. Capital and Funding - The Company expects to need to raise additional capital beginning in late 2020 [130]. - The Company has experienced recurring operating losses and negative operating cash flows since inception [126]. - Management has concluded that there is substantial doubt about the Company's ability to continue as a going concern within one year of the date of the financial statements [127]. - The Company is required to pay Moffitt an annual license maintenance fee of $25,000 starting from the first anniversary of the License Agreement [207]. - The Company is obligated to make milestone payments to INSERM totaling up to $1,750,000 upon achieving development milestones and up to $6,500,000 upon achieving commercial milestones under the Patent Assignment and Exploitation Agreement [205]. - The Company has a current plan to complete the validation process for LB-100 within three years, but requires substantial additional capital for commercialization [205]. Drug Development and Collaboration - The Company has two classes of drugs under development for cancer treatment: LB-100 (protein phosphatase inhibitors) and LB-200 (histone deacetylase inhibitors) with potential applications in neurodegenerative diseases [152]. - The Company is collaborating with leading academic research centers globally to evaluate LB-100's efficacy against various cancers, demonstrating significant scientific interest due to its novel mechanism of action [154]. - LB-100 has been shown to enhance the effectiveness of standard cytotoxic drugs and PD-1 blockers in pre-clinical studies, indicating its potential role in cancer immunotherapy [155]. - The LB-200 series has shown broad activity against many cancer types but is currently not being actively pursued for clinical development due to resource allocation towards LB-100 [158]. - The Company is expanding its patent portfolio to enhance the value of LB-100 as it progresses through the FDA-approval process [172]. Operational Costs - The Company incurred costs of $15,529 and $48,493 for the three and six months ended June 30, 2019, respectively, under a work order agreement with Theradex [142]. - The Company recorded charges to operations of $30,000 and $40,000 related to the Collaboration Agreement with BioPharmaWorks during the three months and six months ended June 30, 2019 and 2018, respectively [204]. - The Company recorded charges to operations of $6,233 and $21,507 in connection with the license agreements during the three months and six months ended June 30, 2019, respectively [208]. - The Company recorded a charge to operations of $2,294 for the retainer payment to Liberi Life Sciences Consultancy during the three months ended June 30, 2019 and 2018 [206]. - The Company paid Moffitt $13,253 pursuant to the Clinical Trial Research Agreement during the three months and six months ended June 30, 2019 [211].

UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 [ ] TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 Commission file number: 000-51476 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) Identification Number) Delaware 20-2903526 248 Route 25A, No. 2 East Setauket, New York 11733 (Address of principal executive offices) FORM 10- ...

Financial Performance - The Company has not generated any revenues from operations to date and does not expect to do so in the foreseeable future [143]. - The Company reported no revenues for the years ended December 31, 2018 and 2017 [199]. - The net loss for the year ended December 31, 2018 was $2,133,128, compared to a net loss of $1,808,414 in 2017 [206]. - General and administrative costs increased by $754,817 or 56.2% in 2018 compared to 2017, totaling $2,097,348 [202]. - Research and development costs decreased by $426,555 or 91.3% in 2018 compared to 2017, amounting to $40,703 [205]. - Operating activities utilized cash of $1,511,034 in 2018, compared to $1,412,181 in 2017 [211]. - The Company has substantial doubt about its ability to continue as a going concern due to recurring operating losses and negative cash flows [207]. - As of December 31, 2018, the Company had working capital of $4,123,530, an increase of $3,128,489 from $995,041 at December 31, 2017 [208]. - Cash available to fund operations at December 31, 2018 was $4,273,012 [209]. Clinical Trials and Research - The Company received FDA approval for its IND Application to conduct a Phase 1b/2 clinical trial for its lead compound LB-100, expected to begin in Q2 2019 [145]. - The clinical trial is anticipated to take approximately three years to complete, with patient accrual expected to last two years [146]. - LB-100 showed anti-tumor activity in a Phase 1 clinical trial, with tumor shrinkage lasting for 11 months in one pancreatic cancer patient and disease stabilization for over 4 months in 9 other patients out of 20 [176]. - Pre-clinical studies indicate that LB-100 enhances the effectiveness of standard cytotoxic drugs and PD-1 blockers without increasing toxicity [179]. - The Company is focusing on demonstrating the therapeutic benefit of LB-100 in Phase 2 clinical trials, particularly for cancers like myelodysplastic syndrome (MDS) and small cell lung cancer (SCLC) [189]. - A Phase 1b/2 clinical trial for LB-100 in patients with del(5q) MDS is expected to begin in Q2 2019, with a two-year patient accrual period [190]. - The Company has established collaborations with leading academic research centers to further investigate LB-100's efficacy in various cancers [177]. - The Company is exploring partnerships for additional financing to support upcoming clinical trials, including those for SCLC and LB-100 combined with PD-1 inhibitors [194]. Drug Development - The Company has two classes of drugs under development for cancer treatment: LB-100 (protein phosphatase inhibitors) and LB-200 (histone deacetylase inhibitors) with potential applications in neurodegenerative diseases [175]. - The LB-200 series has shown broad activity against various cancer types but is currently not being actively pursued due to the focus on LB-100 [182]. - The patent portfolio includes multiple uses of LB-100 and its analogs for various cancers and non-neoplastic diseases, indicating a strong intellectual property position [181]. Funding and Partnerships - The Company is dependent on raising additional equity capital to fund its research and development activities [150]. - The Company entered into a Consulting Agreement with Liberi Life Sciences Consultancy BV, paying a one-time retainer of €15,000 (US $18,348) and 2.5% of net payments from sales or licensing activities generated by the advisor [221]. - The Company has an Exclusive License Agreement with Moffitt Cancer Center, which includes a non-refundable license issue fee of $25,000 and milestone payments totaling $1,897,000, subject to a 40% reduction under certain conditions [222]. - 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 and $100,000 in year five and thereafter [223]. - A Clinical Trial Research Agreement with Moffitt for a Phase 1b/2 clinical trial of the Company's lead compound LB-100 is effective for five years, unless terminated earlier [224]. - The Company entered into a work order agreement with Theradex for monitoring the clinical trial, with estimated costs of approximately $954,000, of which $11,906 has been incurred as of December 31, 2018 [226]. Operational Status - The Company has experienced recurring operating losses and negative operating cash flows since inception [147]. - Management has expressed substantial doubt about the Company's ability to continue as a going concern within one year of the financial statements being issued [148]. - As of December 31, 2018, the Company had not commenced revenue-generating operations and relies on raising equity capital for funding [196]. - As of December 31, 2018, the Company had no off-balance sheet arrangements [227].