Cyclacel Pharmaceuticals (CYCC) Q2 Earnings call transcript Aug 14, 2024

In the recent earnings call, Cyclacel Pharmaceuticals Inc. shared significant updates on their financial performance and business strategies, highlighting the progress of their precision medicine strategy for Fadra, an oral CDK2/9 inhibitor. This call was a testament to the company's strategic focus on precision medicine and its potential impact on various solid tumors and lymphomas.

Strategic Focus on Precision Medicine and Fadra's Competitive Profile

The company's precision medicine strategy for Fadra, an oral CDK2/9 inhibitor, has been a key focus in the call. Spiro Rombotis, Cyclacel's President and CEO, emphasized the unmet medical need and industry interest in the patient population identified by CDKN2A or CDKN2B deletions, which are closely located on chromosome 9 and often co-deleted. The potential of Fadra in addressing these genetic abnormalities and its strong competitive profile in the therapeutic class has been a significant highlight.

Clinical Progress and Anticipated Results

Brian Schwartz, Chief Medical Officer, shared details about the clinical progress of Fadra, with recruitment going well in the Phase II proof-of-concept study. The study is evaluating Fadra as monotherapy in patients with CDKN2A and/or CDKN2B chromosomal abnormalities. The anticipation of reporting initial results from around a dozen patients by the end of the year is a positive sign of the drug's potential efficacy.

Financial Highlights and Cash Resources

Paul McBarron, Executive Vice President, Finance and Chief Operating Officer, provided an update on the financial highlights for the second quarter of 2024. Despite a net loss of $3.3 million, the company's cash resources are estimated to fund planned programs into the fourth quarter of 2024. This is a significant achievement, considering the company's focus on advancing its clinical programs, particularly Fadra.

Ahu Demir's Questions and Discussion on CDK2, CDKN2B Loss

Ahu Demir, an analyst from Ladenburg Thalmann, asked several insightful questions about the CDK2, CDKN2B program, including the enrollment target and scenarios for the program. Brian Schwartz's response indicated a 2-stage process, with the first stage requiring at least 2 complete responses in the first 12 to 14 patients. The second phase would confirm these responses in a larger cohort. Ahu also inquired about the potential impact of different mutations on Fadra's efficacy. Paul McBarron suggested that the company would be able to get a feel for this from the data disclosure in the second half of the year.

Looking Ahead

Cyclacel's earnings call has provided a comprehensive update on the company's financial performance and strategic focus on precision medicine. The progress of Fadra in the Phase II proof-of-concept study and the anticipated reporting of initial results in the second half of the year are significant milestones. The company's financial position, despite a net loss, is encouraging, given the focus on advancing its clinical programs. Overall, Cyclacel's strategic direction and the potential of Fadra in addressing specific chromosomal abnormalities hold significant promise for the future.