On March 19, 2024 Cyclacel Pharmaceuticals, Inc. (NASDAQ: CYCC, NASDAQ: CYCCP; "Cyclacel" or the "Company"), a biopharmaceutical company developing innovative medicines based on cancer cell biology, reported fourth quarter and full year 2023 financial results and provided a business update (Press release, Cyclacel, MAR 19, 2024, View Source [SID1234641261]).
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"Following the recently announced precision medicine strategy for oral fadraciclib, our CDK2/9 inhibitor, we have determined the recommended Phase 2 dose (RP2D) and are ready to start proof-of-concept studies," said Spiro Rombotis, President and Chief Executive Officer. "We expect two key data readouts for fadraciclib this year. These include pharmacokinetic (PK), pharmacodynamic (PD), safety and activity data from the dose escalation part of the 065-101 Phase 1/2 study. In addition, we expect to report initial clinical activity from the Phase 2 proof of concept part, evaluating cohorts of patients selected for their mutational profile and/or Phase 1 activity in various solid tumors and lymphoma. At the upcoming AACR (Free AACR Whitepaper) Annual Meeting 2024, independent investigators will present preclinical proof-of-concept data for fadraciclib further demonstrating fadraciclib’s differentiated properties from other next generation CDK inhibitors."
"We have observed CDKN2A/CDKN2B alterations, including loss of function, in multiple, pretreated patients with various cancers, including gynecological, hepatobiliary, lung, and pancreatic, who benefitted from fadraciclib monotherapy. In addition, we have observed clinical activity in patients with T cell lymphoma, said Brian Schwartz, M.D., interim Chief Medical Officer. "We expect to report final Phase 1 results including details on patient genomic profiles at an upcoming medical conference. A precision medicine strategy is also emerging for plogosertib, our PLK1 inhibitor. Preclinical data from independent groups have shown that certain ARID1A- and SMARCA-mutated cancers may benefit from treatment with plogosertib. Before testing this hypothesis in our 140-101 dose escalation study, we plan to switch to a new oral formulation of plogosertib with improved bioavailability. We are excited about the potential precision medicine strategies for both our clinical programs, with initial data from the fadraciclib Phase 2 proof-of-concept study."
Key Highlights for 2024
· First patient dosed with oral fadraciclib in Phase 2 proof-of-concept part of 065-101 study in patients with advanced solid tumors and lymphoma
· Report final data from dose escalation stage from the 065-101 study of oral fadraciclib in patients with advanced solid tumors and lymphoma
· Report interim data from initial cohorts in Phase 2 open label, proof-of-concept part of 065-101 study with oral fadraciclib in patients with advanced solid tumors and lymphoma
· Independent investigators to report preclinical proof-of-concept data for fadraciclib at the American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting 2024
Financial Highlights
As of December 31, 2023, pro forma cash and cash equivalents totaled $6.3 million, including $2.9 million of United Kingdom research & development tax credits which were received after the end of the year. Cash and cash equivalents as of December 31, 2023, totaled $3.4 million, compared to $18.4 million as of December 31, 2022. Net cash used in operating activities was $16.1 million for the twelve months ended December 31, 2023 compared to $20.8 million for the same period of 2022. The Company estimates that its available cash, including the United Kingdom research & development tax credit of $2.9 million, will fund currently planned programs into the second quarter of 2024.
Research and development (R&D) expenses were $3.5 million and $19.2 million for the three months and year ended December 31, 2023, as compared to $6.7 million and $20.3 million for the same period in 2022. R&D expenses relating to fadraciclib were $2.7 million and $13.4 million for the three months and year ended December 31, 2023, as compared to $5.3 million and $14.0 million for the same period in 2022 due to decrease in clinical trial costs offset by an increase in manufacturing and other non-clinical expenditures. R&D expenses related to plogosertib were $0.7 million and $5.0 million for the three months and year ended December 31, 2023, as compared to $1.3 million and $5.5 million for the same period in 2022 due to decrease in manufacturing and other non-clinical expenditures.
General and administrative expenses for the three months and year ended December 31, 2023, were $1.9 million and $6.7 million, compared to $2.1 million and $7.4 million for the same period of the previous year due to a decrease in professional fees.
Total other income, net, for the three months and year ended December 31, 2023, were an expense of $0.3 million and expense of $0.1 million, compared to an expense of $0.2 million and income of $1.7 million for the same period of the previous year. The decrease of $1.8 million for the year ended December 31, 2023, is primarily related to royalty income received in the previous year.
United Kingdom research & development tax credits for the three months and year ended December 31, 2023 were $0.4 million and $3.0 million compared to $1.6 million and $4.7 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 and year ended December 31, 2023, was $5.3 million and $22.6 million (including stock based compensation expense of $0.3 million and $1.5 million respectively), compared to $7.4 million and $21.2 million (including stock based compensation expense of $0.3 million and $1.5 million respectively) for the same period in 2022.