Cyclacel(US:CYCC)2024-05-15 00:08Financial Data and Key Metrics Changes - As of March 31, 2024, pro-forma cash and cash equivalents totaled $9.9 million, which includes proceeds from a private placement and $0.8 million from the UK R&D Tax Credit Claim for 2023. Cash and cash equivalents decreased to $2.8 million from $3.4 million as of December 31, 2023 [8] - Net cash used in operating activities was $0.5 million for Q1 2024, compared to $6.9 million for the same period in 2023 [8] - Net loss for Q1 2024 was $2.9 million, down from $5.8 million in Q1 2023, indicating a reduction in expenditures as resources are concentrated on the Fadra Phase 2 study [11] Business Line Data and Key Metrics Changes - Research and development (R&D) expenses were $2.8 million for Q1 2024, down from $5.7 million in Q1 2023. R&D expenses related to Fadra were $1.8 million, compared to $4.1 million in the same period last year [9] - Expenses related to plogo decreased to $1 million in Q1 2024 from $1.4 million in Q1 2023 due to a pause in the 140-101 study [9] Market Data and Key Metrics Changes - The company is focusing on patients with CDKN2A or B alterations, which are associated with several solid tumors and T-cell lymphomas, indicating a targeted approach in a market with high unmet medical needs [15][16] Company Strategy and Development Direction - The company is pursuing a precision medicine approach for Fadra, targeting patients with specific chromosomal abnormalities. The Phase 2 study is evaluating patients based on their mutational profile and prior Phase 1 activity [15] - Key milestones include reporting data from the dose escalation stage of the 065-101 study at the ASCO 2024 Annual Meeting and initial clinical activity from the Phase 2 proof of concept part later in 2024 [26] Management's Comments on Operating Environment and Future Outlook - Management expressed optimism about the ongoing Phase 2 study and the potential for Fadra to address significant unmet medical needs in cancer treatment [15][16] - The company anticipates that its current cash resources will fund planned programs into Q4 2024, indicating a stable financial outlook for the near term [11] Other Important Information - The company has opened additional sites for the Phase 2 study to expedite patient enrollment, with expectations to deliver initial results by the second half of 2024 [5][15] Q&A Session Summary Question: What are the expectations for the fadraciclib 101 study at ASCO? - Management plans to present nearly the totality of the dose escalation portion of the study, including safety and efficacy data [12][13] Question: What is the timeline for the proof of concept Phase 2 portion of the study? - The company anticipates enrolling both cohorts by the end of the year, with additional T-cell lymphoma sites recently opened [29] Question: How are patients with mutations identified for the study? - The mutations are part of standard panels, and no companion diagnostic is needed, although data is being collected for future regulatory discussions [31]