On August 14, 2024 Cyclacel Pharmaceuticals, Inc. (NASDAQ: CYCC, NASDAQ: CYCCP; "Cyclacel" or the "Company"), a biopharmaceutical company developing innovative medicines based on cancer cell biology, reported second quarter financial results and provided a business update (Press release, Cyclacel, AUG 14, 2024, View Source [SID1234645894]).

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"Following oral fadraciclib data presented at the 2024 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting, the Phase 2 stage of our 065-101 study is enrolling well," said Spiro Rombotis, President and Chief Executive Officer. "We are on track to report in the fourth quarter of 2024 initial data from the precision medicine cohort of 065-101 with our CDK2/9 inhibitor as monotherapy in patients with advanced solid tumors and later on in patients with T-cell lymphoma."

"We are enrolling patients prospectively selected for CDKN2A/CDKN2B alterations in the Phase 2, proof of concept (PoC) stage of 065-101," said Brian Schwartz, M.D., interim Chief Medical Officer. "We are pleased with strong investigator interest and are nearing completion of recruitment in the precision medicine cohort. There are no approved medicines for patients with CDKN2A/CDKN2B alterations. A second cohort to evaluate fadraciclib in patients with T-cell lymphoma is open for enrollment. We are encouraged about fadraciclib’s prospects and look forward to presenting emerging data from the 065-101 study later in the year."

Financial Highlights

As of June 30, 2024, cash equivalents totalled $6.0 million, compared to $3.4 million as of December 31, 2023. Net cash used in operating activities was $3.6 million for the six months ended June 30, 2024 compared to $8.2 million for the same period of 2023. Net cash provided by financing activities was approximately $6.3 million, net of expenses, for the six months ended June 30, 2024 from the issuance of common stock and warrants. The Company estimates that its current cash resources will fund planned programs into the fourth quarter of 2024.

Research and development (R&D) expenses were $2.0 million for the three months ended June 30, 2024, as compared to $4.7 million for the same period in 2023. R&D expenses relating to fadraciclib were $1.5 million for the three months ended June 30, 2024, as compared to $3.0 million for the same period in 2023 due to a decrease in clinical trial and other non-clinical expenditures. R&D expenses related to plogosertib were $0.5 million for the three months ended June 30, 2024, as compared to $1.4 million for the same period in 2023 due to a decrease in manufacturing costs and other non-clinical expenditures.

General and administrative expenses remained flat at approximately $1.6 million for each of the three months ended June 30, 2024 and 2023.

Total other expenses, net, for the three months and year ended June 30, 2024 were $0.1 million for each of the three months ended June 30, 2024 and 2023.

United Kingdom research & development tax credits for the three months ended June 30, 2024 were $0.4 million, compared to $0.6 million for the same period of the previous year and are directly correlated to qualifying research and development expenditure.

Net loss for the three months ended June 30, 2024, was $3.3 million (including stock-based compensation expense of $0.2 million), compared to $5.5 million (including stock-based compensation expense of $0.4 million) for the same period in 2023.

Conference call information:

Call: (800) 225-9448 / international call: (203) 518-9708

Archive: (800) 934-7884 / international archive: (402) 220-6987

Code for live and archived conference call is CYCCQ224. Webcast link

For the live and archived webcast, please visit the Corporate Presentations page on the Cyclacel website at www.cyclacel.com. The webcast will be archived for 90 days and the audio replay for 7 days.