Financial Data and Key Metrics Changes - As of June 30, 2024, cash equivalents totaled 3.4 million as of December 31, 2023 [9] - Net cash used in operating activities was 8.2 million for the same period in 2023 [9] - Net loss for the three months ended June 30, 2024, was 5.5 million for the same period in 2023 [10] Business Line Data and Key Metrics Changes - Research and development (R&D) expenses were 4.7 million for the same period in 2023 [9] - R&D expenses related to Fadra were 3 million for the same period in 2023 [9] - R&D expenses for plogosertib were 1.4 million for the same period in 2023 [9] Market Data and Key Metrics Changes - The company is focusing on a precision medicine strategy for Fadra, an oral CDK29 inhibitor, with recruitment in the enriched cohort of the Phase 2 proof-of-concept study progressing well [3][5] - Initial clinical activity from the Phase 2 proof-of-concept study is expected to be reported starting in the fourth quarter of 2024 [5] Company Strategy and Development Direction - The company aims to address unmet medical needs in patients with CDKN2A and/or CDKN2B chromosomal abnormalities through its Fadra program [3][5] - The competitive profile of Fadra is considered strong within its therapeutic class, with expectations for significant clinical data in the near future [5] Management's Comments on Operating Environment and Future Outlook - Management expressed optimism about the recruitment pace in the Fadra study and anticipates reporting initial results from around a dozen patients by the end of 2024 [6][13] - The company is focused on evaluating specific cancer types in the Phase 2 proof-of-concept study based on preliminary data [8] Other Important Information - The United Kingdom research and development tax credits for the three months ended June 30, 2024, were 6 million for the same period in the previous year [10] - The company estimates that its current cash resources will fund planned programs into the fourth quarter of 2024 [9] Q&A Session Summary Question: What is the enrollment target for the CDKN2A and 2B program? - The target is approximately 12 to 14 patients, with a need to see more than two responses to move to the next phase of the study [11][12] Question: How many patients are you planning to show data in the second half of this year? - The company anticipates presenting response data from around a dozen patients by the end of the year [13] Question: Is there any reason to change the local CDKN2B, 2A and 2B to a more potent form instead of the mutations and other alterations? - The company will analyze various alterations and mutations to determine their impact on drug efficacy [14]
Cyclacel(CYCC) - 2024 Q2 - Earnings Call Transcript