Cyclacel Pharmaceuticals Q1 Financial Results and Business Update

Cyclacel Pharmaceuticals, Inc., a biopharmaceutical company specializing in innovative cancer treatments, has released its first-quarter financial results and shared a business update. The company has started enrolling patients in the Phase 2 proof-of-concept (PoC) stage of its 065-101 study for fadraciclib, an oral CDK2/9 inhibitor. Cyclacel's CEO, Spiro Rombotis, expressed optimism about delivering key study results within the year. The company has secured an additional $8.0 million through a private placement, which bolsters its financial resources for ongoing clinical programs. Upcoming data from the Phase 1 dose-escalation stage of the 065-101 study in patients with advanced solid tumors and lymphoma will be presented at the American Society of Clinical Oncology (ASCO) Annual Meeting. Preliminary data suggests fadraciclib stands out among next-generation CDK inhibitors.

Interim Chief Medical Officer, Dr. Brian Schwartz, noted that the company has determined the recommended Phase 2 dose for fadraciclib and is now focusing on enrolling patients with specific genetic alterations (CDKN2A/CDKN2B) and T-cell lymphoma. These cohorts are particularly important as there are currently no approved treatments for patients with these genetic alterations. The company anticipates involving up to seven trial sites, primarily in the United States, and looks forward to presenting more data later in the year.

Cyclacel has outlined two key milestones for 2024: reporting the final data from the dose-escalation stage and the recommended Phase 2 dose (RP2D) determination at the ASCO Annual Meeting, and sharing interim data from the initial cohorts in the Phase 2 proof-of-concept stage.

Financially, Cyclacel's cash and cash equivalents amounted to $9.9 million as of March 31, 2024, which includes proceeds from the recent private placement and a $0.8 million research and development tax credit from the United Kingdom. Their cash resources are projected to fund planned programs into the fourth quarter of 2024.

Research and development (R&D) expenses for the first quarter of 2024 were $2.8 million, a significant decrease from $5.7 million in the same period in 2023. The reduction in R&D expenses is attributed to lower clinical trial and non-clinical expenditures for fadraciclib, dropping from $4.1 million to $1.8 million, and for plogosertib, decreasing from $1.4 million to $1.0 million. General and administrative expenses remained stable at approximately $1.6 million for both the first quarters of 2024 and 2023.

Other expenses for the first quarter of 2024 were $0.1 million, compared to $0.2 million in the same period of the previous year. Additionally, the company received $1.4 million in research and development tax credits, which is directly linked to qualifying R&D expenditures.

Cyclacel reported a net loss of $2.9 million for the first quarter of 2024, including $0.2 million in non-cash stock-based compensation expenses. This is a notable improvement compared to the net loss of $5.8 million, which included $0.4 million in non-cash stock-based compensation expenses, in the same period in 2023.

The company's strategic focus remains on advancing its pipeline of novel drug candidates aimed at oncology and hematology indications, leveraging its expertise in cell cycle, transcriptional regulation, and mitosis biology. Cyclacel continues to build a diversified biopharmaceutical business grounded in innovative cancer therapies.