Cyclacel(US:CYCC)2019-11-13 22:11Revenue Generation - Revenues for the three months ended September 30, 2018 and 2019 were $0, indicating no revenue generation during this period[115] Research and Development Expenses - Research and development expenses decreased by $0.1 million from $1.2 million for the three months ended September 30, 2018 to $1.1 million for the same period in 2019, representing a 12% decrease[121] - Research and development expenses related to transcriptional regulation remained flat at $726,000 for both periods, while expenses for sapacitabine decreased by $249,000, or 79%[119] - Total research and development expenses represented 49% and 45% of operating expenses for the three months ended September 30, 2018 and 2019, respectively[120] - The company anticipates an increase in overall research and development expenses for the year ended December 31, 2019 compared to 2018 as clinical development progresses[122] - Total research and development expenses remained relatively flat at $3.2 million for the nine months ended September 30, 2018 and 2019, representing 45% and 47% of operating expenses respectively[136] General and Administrative Expenses - General and administrative expenses increased slightly from $1.25 million in 2018 to $1.285 million in 2019, a 3% increase[123] - General and administrative expenses decreased by $0.2 million from $3.9 million for the nine months ended September 30, 2018 to $3.7 million for the nine months ended September 30, 2019[140] - General and administrative expenses represented 51% and 55% of operating expenses for the three months ended September 30, 2018 and 2019, respectively[123] Clinical Studies and Collaborations - The company is evaluating CYC065 in combination with venetoclax in two clinical studies for patients with relapsed refractory chronic lymphocytic leukemia and acute myeloid leukemia[107] - A Phase 1/2 study of sapacitabine in combination with venetoclax is intended to enroll up to 40 patients with relapsed or refractory AML or myelodysplastic syndromes[110] - The company entered into a Clinical Collaboration Agreement with MD Anderson Cancer Center to evaluate the safety and efficacy of three Cyclacel medicines in patients with hematological malignancies, with a total projected enrollment of up to 170 patients[113] Income and Cash Flow - Total other income increased by approximately $0.1 million from $0.1 million for the three months ended September 30, 2018 to $0.2 million for the three months ended September 30, 2019[126] - Foreign exchange gains increased by approximately $78,000, from a gain of $1,000 for the three months ended September 30, 2018, to a gain of $79,000 for the three months ended September 30, 2019[127] - Total income tax benefit decreased by $0.1 million from $1.0 million for the nine months ended September 30, 2018 to $0.9 million for the nine months ended September 30, 2019[147] - Total other income decreased by approximately $0.3 million, from $0.8 million for the nine months ended September 30, 2018 to $0.5 million for the nine months ended September 30, 2019[142] - Net cash used in operating activities increased by $3.6 million, from $4.7 million for the nine months ended September 30, 2018 to $8.3 million for the nine months ended September 30, 2019[152] - Net cash provided by financing activities increased by $4.1 million for the nine months ended September 30, 2019 due to approximately $4.1 million in net proceeds from the issuance of common stock[154] - Cash and cash equivalents decreased from $18.973 million as of September 30, 2018 to $12.967 million as of September 30, 2019[149] Financial Position and Future Funding - The accumulated deficit as of September 30, 2019 was $355.3 million[149] - The company expects to continue incurring substantial operating losses in the future and cannot guarantee significant product revenues until FDA or EMA approval and successful commercialization[155] - Existing funds, along with cash generated from operations and recent financing activities, are deemed sufficient to meet planned working capital and capital expenditures through the end of 2020, but the company lacks sufficient funds for drug candidate development and commercialization[156] - Future funding requirements will depend on various factors, including clinical trial costs, manufacturing capabilities, and costs associated with acquiring businesses or technologies[157] - The company plans to evaluate in-licensing and acquisition opportunities to access new drugs or drug targets, which may increase future funding needs[156] - Future cash needs are expected to be financed primarily through public or private equity offerings, debt financings, or strategic collaborations[159] - The company is not reliant on institutional credit finance, but it is dependent on the availability of funds and activity in equity markets[159] - If additional funding is not secured when needed, the company may have to delay or reduce clinical trials or research programs[159] - The company may need to partner product candidate programs at earlier stages of development, potentially lowering their economic value[159] - The costs of filing and enforcing patent claims and obtaining FDA and EMA approvals will impact future funding requirements[158] - The company is not required to provide market risk disclosures as a smaller reporting company[160]