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].
Lixte Biotechnology(LIXT) - 2019 Q2 - Quarterly Report