Cyclacel Pharmaceuticals reports Q4 EPS (60c), consensus (48c)

As of December 31 cash and cash equivalents totaled $18.3M, compared to $36.6M as of December 31. Net cash used in operating activities was $20.8M for the twelve months ended December 31 compared to $18.5M for the same period of 2021. The Company estimates that its available cash, including the United Kingdom research & development tax credit receivable of $4.7M, will fund currently planned programs into the fourth quarter of 2023. . "After a productive 2022, we anticipate that 2023 will be even more exciting for Cyclacel. We plan to advance oral fadraciclib, our CDK2/9 inhibitor, into Phase 2 proof-of-concept evaluating multiple cancer cohorts, and also further explore the anti-cancer potential of our oral PLK1 inhibitor plogosertib," said Spiro Rombotis, President and Chief Executive Officer. "We expect three key data readouts this year, including pharmacokinetic pharmacodynamic , safety and activity data from the dose escalation part of our fadraciclib 065-101 Phase 1/2 study, initial clinical activity data from the Phase 2 proof of concept stage of the study and PK, PD, safety and activity data from the dose escalation part of our 140-101 Phase 1/2 study of plogosertib. These data have the potential to further demonstrate that fadraciclib and plogosertib are differentiated from other molecules in their respective classes.""We are pleased with our pipeline’s progress in 2022 and believe that we have the opportunity to demonstrate promising results for our two drug candidates, fadraciclib and plogosertib, in the year ahead," said Mark Kirschbaum, M.D., Chief Medical Officer. "At the recent ENA 2022 Symposium we reported fadraciclib’s good tolerability profile and clear anti-cancer signals. We are currently recruiting patients at dose level 6a of 125mg administered orally twice daily for four out of four weeks. We plan to optimize the dosing schedule and move into Phase 2 testing of the tumor types that should be most sensitive to fadraciclib treatment. We are also advancing plogosertib through dose escalation and are now recruiting patients at dose level 4 in our Phase 1/2 solid tumor study. We have observed efficacy at lower dose levels with three patients on treatment for three to eight cycles. We expect to report additional data of our mechanistically differentiated PLK1 inhibitor from this trial later this year. We remain enthusiastic about Cyclacel’s advancing clinical-stage pipeline and look forward to presenting emerging data from these two programs during the year."