Release Date: August 14, 2024
For the complete transcript of the earnings call, please refer to the full earnings call transcript.
Positive Points
- Recruitment in the enriched cohort of the 065-101 phase 2 proof-of-concept study is progressing well.
- Fadraciclib (Fadra) has shown clinical benefits in heavily pre-treated patients with various tumor types.
- The company has opened a second cohort for patients with T-cell lymphoma based on promising phase 1 results.
- Cash equivalents increased to $6 million as of June 30, 2024, compared to $3.4 million as of December 31, 2023.
- Net cash used in operating activities decreased significantly to $3.6 million for the first half of 2024, compared to $8.2 million for the same period in 2023.
Negative Points
- The most commonly reported treatment-related adverse events for Fadra include nausea, vomiting, diarrhea, fatigue, and hyperglycemia.
- A total of 25 drug-related serious adverse events (SAEs) were reported in eight patients.
- R&D expenses for the three months ended June 30, 2024, were $2 million, indicating ongoing high costs.
- The company estimates that its current cash resources will only fund planned programs into the fourth quarter of 2024.
- Net loss for the three months ended June 30, 2024, was $3.3 million, indicating continued financial challenges.
Q & A Highlights
Highlights from Cyclacel Pharmaceuticals Inc (CYCC, Financial) Q2 2024 Earnings Call
Q: What is the enrollment target for the CDKN2A and 2B program? What are the scenarios for this program, and what would be the benchmark for success based on the data you plan to disclose in the second half of this year?
A: (Brian Schwartz, Interim Chief Medical Officer) The program follows a two-stage process. Stage one involves approximately 12 to 14 patients, where more than two responses are needed to move to the next phase. Success in the first part will be defined by at least two responses in the initial 12 to 14 patients.
Q: How many patients are you planning to show data for in the second half of this year, and what is the target enrollment for this program?
A: (Brian Schwartz, Interim Chief Medical Officer) We anticipate presenting data from around a dozen patients by the end of the year. Accrual has been good, and the necessary patients have been screened.
Q: In terms of alterations, is there any reason to believe that deletions in CDKN2A and CDKN2B would be more potent than mutations? Will the data disclosure in the second half show the status of these different alterations?
A: (Brian Schwartz, Interim Chief Medical Officer) We will be able to get a feel from our treated patients to see if specific alterations are more responsive to the drug. There are numerous different alterations, and we hope to narrow it down further from our analysis.
Q: Can you provide an update on the financial status and cash resources of the company?
A: (Paul McBarron, Chief Operating Officer) As of June 30, 2024, cash equivalents totaled $6 million. Net cash used in operating activities was $3.6 million for the first six months of 2024. The company estimates that its current cash resources will fund planned programs into the fourth quarter of 2024.
Q: What were the R&D expenses for the second quarter of 2024, and how do they compare to the same period in 2023?
A: (Paul McBarron, Chief Operating Officer) R&D expenses were $2 million for Q2 2024, compared to $4.7 million for the same period in 2023. Expenses related to Fadra were $1.5 million, down from $3 million in 2023, due to decreased clinical trial and non-clinical expenditures.
Q: What are the key milestones achieved for Fadra, and what are the upcoming catalysts for 2024?
A: (Spiro Rombotis, President and CEO) Key milestones include multiple patients dosed in the phase 2 proof-of-concept stage. Upcoming catalysts include reporting interim data from initial cohorts in the phase 2 proof-of-concept stage of the 065-11 study with oral Fadra in patients with advanced solid tumors and lymphoma.
Q: What were the most common treatment-related adverse events observed in the phase 1 study of Fadra?
A: (Brian Schwartz, Interim Chief Medical Officer) The most common treatment-related adverse events were nausea, vomiting, diarrhea, fatigue, and hyperglycemia. A total of 25 drug-related serious adverse events (SAEs) were reported in eight patients.
Q: Can you summarize the clinical benefit observed in the phase 1 study of Fadra?
A: (Brian Schwartz, Interim Chief Medical Officer) Clinical benefit was observed in patients with various tumor types, including endometrial, lung, ovarian, pancreatic cancer, and T-cell lymphoma. Two partial responses were reported in patients with T-cell lymphoma, and a squamous non-small cell lung cancer patient achieved a 22% reduction in tumor burden.
Q: What were the financial highlights for the second quarter of 2024?
A: (Paul McBarron, Chief Operating Officer) Net loss for Q2 2024 was $3.3 million, including stock-based compensation expense of $0.2 million, compared to $5.5 million for the same period in 2023. General and administrative expenses remained flat at approximately $1.6 million.
Q: What is the status of the second cohort recruiting patients with T-cell lymphoma?
A: (Brian Schwartz, Interim Chief Medical Officer) The second cohort is recruiting well, based on phase 1 single productivity, including partial responses in two out of three patients with T-cell lymphoma.
For the complete transcript of the earnings call, please refer to the full earnings call transcript.
