Financial Data and Key Metrics Changes - As of June 30, 2022, cash and cash equivalents totaled 36.6 million as of December 31, 2021, with available cash resources expected to fund planned programs into the second half of 2023 [31] - Research and development (R&D) expenses were 4.1 million in Q2 2021 [31] - Net loss for Q2 2022 was 5.1 million for the same period in 2021 [34] Business Line Data and Key Metrics Changes - R&D expenses related to the lead product candidate, oral fadraciclib (fadra), were 2.8 million in Q2 2021, attributed to increased clinical trial costs [32] - R&D expenses for CYC140 were 1.1 million in Q2 2021, due to the initiation of the CYC140 Phase 1/2 study [33] Market Data and Key Metrics Changes - The 065-101 study of oral fadra is enrolling well at four sites in the US, South Korea, and Spain, with 17 patients enrolled in the dosage escalation part of the study [9][10] - The company is also testing oral fadra for leukemia and myelodysplastic syndromes in study 065-102, which is currently enrolling patients [23] Company Strategy and Development Direction - The company aims to establish oral fadra as a best-in-class CDK inhibitor, focusing on its dual targeting of CDK2 and CDK9, good tolerability, and preliminary anti-cancer activity [11][12] - The company plans to hold an R&D day in the fall to provide updates on clinical programs and preclinical work [29] Management's Comments on Operating Environment and Future Outlook - Management expressed optimism about the safety and anti-cancer activity of oral fadra, noting the encouraging results in heavily pretreated patients [7][8] - The company anticipates building momentum as the fadra solid tumor trial progresses, along with other clinical stage programs [48] Other Important Information - The company has made progress in advancing its novel PLK1 inhibitor, CYC140, into a Phase 1/2 study for solid tumors and lymphomas, with no dose-limiting toxicities observed so far [27][28] Q&A Session Summary Question: Plans for R&D Day and safety data from fadra program - Management confirmed that updates, including safety data, will be presented during the R&D Day event in Q3 [35][36] Question: Synergistic toxicity of inhibiting CDK2 and CDK9 - Management indicated that no toxicity has been observed in the study so far [37] Question: Indications for CYC140 and enrollment rates - Management discussed ongoing dose escalation and indicated that solid tumors and lymphomas are currently the focus, with plans to activate the leukemia part of the study later [41][42] Question: Upcoming conferences and data presentations - Management mentioned that an abstract has been submitted for an upcoming oncology conference, with expectations for data updates in the second half of the year [43][45]
Cyclacel(CYCC) - 2022 Q2 - Earnings Call Transcript