Cyclacel Pharmaceuticals Q1 2024 Financial Results and Business Update

Cyclacel Pharmaceuticals, Inc., a biopharmaceutical company focused on innovative cancer treatments, has released its financial results for the first quarter of 2024 and provided significant business updates. The company has initiated patient enrollment for the Phase 2 proof of concept (PoC) study of fadraciclib, an oral CDK2/9 inhibitor. This marks a crucial milestone for Cyclacel as they aim to deliver pivotal clinical data within the year.

Spiro Rombotis, President and CEO of Cyclacel, expressed enthusiasm over the commencement of patient enrollment in the Phase 2 stage of the 065-101 study involving fadraciclib. The company has also strengthened its financial position by securing $8.0 million in gross proceeds through a private placement. These funds, combined with existing resources, will support their ongoing clinical programs. Importantly, data from the Phase 1 dose escalation stage involving patients with advanced solid tumors and lymphoma will be showcased at the upcoming American Society of Clinical Oncology (ASCO) Annual Meeting. Preliminary data indicate that fadraciclib stands out from other CDK inhibitors of the next generation.

Dr. Brian Schwartz, Cyclacel's interim Chief Medical Officer, highlighted the determination of the recommended Phase 2 dose for fadraciclib and the initiation of patient enrollment for the Phase 2 PoC stage. The focus currently lies on a biomarker cohort enrolling patients with CDKN2A/CDKN2B alterations. Following this, patients with T-cell lymphoma will be enrolled. Notably, there are no approved treatments for patients with CDKN2A/CDKN2B alterations. The trial involves up to seven sites, primarily within the United States, and emerging data from this study will be presented later in the year.

Cyclacel has outlined key milestones for 2024, including the reporting of final data from the dose escalation stage and determination of the recommended Phase 2 dose at the ASCO 2024 Annual Meeting. Additionally, interim data from initial cohorts in the Phase 2 PoC stage will be reported.

Financially, Cyclacel reported cash and cash equivalents totaling $9.9 million as of March 31, 2024, inclusive of proceeds from the private placement and a United Kingdom research and development tax credit. This is a decrease from the $3.4 million reported on December 31, 2023. The net cash used in operating activities amounted to $0.5 million for the first quarter of 2024, a significant reduction from the $6.9 million used during the same period in 2023. The existing cash resources are projected to fund the company's planned programs until the fourth quarter of 2024.

Research and development (R&D) expenses saw a notable reduction, falling to $2.8 million for the first quarter of 2024 from $5.7 million in the same period of the previous year. This decrease is attributed to lower clinical trial and non-clinical costs associated with fadraciclib and plogosertib. General and administrative expenses remained stable at approximately $1.6 million for both the first quarters of 2024 and 2023. Other expenses, net, were marginally lower at $0.1 million for the first quarter of 2024 compared to $0.2 million for the same period in the previous year.

The United Kingdom research and development tax credits for the first quarter of 2024 were $1.4 million, which includes an amount related to the 2023 claim received in May 2024. This is slightly higher than the $1.3 million credit for the same period in the prior year. Cyclacel reported a net loss of $2.9 million for the first quarter of 2024, which includes non-cash stock-based compensation expenses, compared to a net loss of $5.8 million for the same period in 2023.

In sum, Cyclacel Pharmaceuticals is making significant strides in advancing its clinical programs while maintaining a solid financial footing. The ongoing studies and upcoming data presentations are pivotal in the company's efforts to develop and commercialize novel cancer treatments.