Cyclacel(US:CYCC)2020-11-12 02:08Financial Data and Key Metrics Changes - As of September 30, 2020, cash and cash equivalents totaled $23.1 million, an increase of $11.2 million from $11.9 million as of December 31, 2019, primarily due to net proceeds of $18.3 million from an equity financing in April 2020, offset by net cash used in operating activities of $6.8 million [30] - The net loss for the three months ended September 30, 2020, was $2.3 million compared to $1.9 million for the same period in 2019 [34] Business Line Data and Key Metrics Changes - Research and development expenses were $1.1 million for each of the three months ended September 30, 2020, and 2019, with an increase in expenses related to the transcriptional regulation program by almost $0.1 million [31] - General and administrative expenses for the three months ended September 30, 2020, were $1.5 million, compared to $1.3 million for the same period of the previous year, reflecting an increase of $0.2 million due to increased professional costs [32] Market Data and Key Metrics Changes - The company has opened two Phase 1 dose escalation studies to evaluate the combination of fadraciclib and venetoclax in patients with relapsed or refractory CLL and AML or MDS [18][22] - The anti-mitotic program is evaluating CYC140, a Polo-like kinase 1 inhibitor, with seven patients recruited for the first-in-human study [24] Company Strategy and Development Direction - The company aims to expand the development of oral fadraciclib initially in solid tumors and later in hematological malignancies, responding to clinician requests for oral therapy [17] - The company is focused on demonstrating safety, efficacy, and cost-effectiveness of its medicines to fulfill its strategy and realize stockholder value [49] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence that cash resources as of September 30 will fund currently planned programs through the end of 2022 [30] - The company plans to report initial data from various studies over the next two years, including the fadraciclib-venetoclax Phase 1 study in relapsed/refractory AML or MDS and CLL [29] Other Important Information - Dr. Mark Kirschbaum was introduced as the new Chief Medical Officer, bringing extensive experience in hematology and oncology [7] - The company is collaborating with The University of Texas MD Anderson Cancer Center for clinical trials, where MD Anderson assumes patient costs for all studies [23] Q&A Session Summary Question: When will the company switch completely to oral fadraciclib if it continues to deliver like intravenous dosing? - Management acknowledged the value of oral therapy and is keen to begin oral evaluation of fadraciclib, with ongoing studies to determine the optimal dosing schedule [35] Question: What proteins are being analyzed in the dose escalation studies? - Management indicated interest in analyzing MCL1, MYC, and cyclin E proteins, with ongoing studies expected to provide more data [40] Question: Are there plans to conduct studies based on recent findings from Duke University regarding CDK2/9 in colorectal cancer? - Management confirmed interest in exploring solid tumors based on preclinical findings but has not yet made decisions regarding specific tumor histologies [42] Question: Any updates on the 160 milligram dose of fadraciclib? - Management clarified that the ongoing Phase 1 study is testing the 160 milligram dose, but the relevance of this dose may change as the program progresses towards oral formulations [44]