On May 11, 2023 Cyclacel Pharmaceuticals, Inc. (NASDAQ: CYCC, NASDAQ: CYCCP; "Cyclacel" or the "Company"), a biopharmaceutical leader in cell cycle checkpoint control developing innovative medicines based on cancer cell biology, reported its first quarter financial results and provided a business update (Press release, Cyclacel, MAY 11, 2023, View Source [SID1234631498]).

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"We are on track to deliver on key readouts this year. For fadraciclib, our oral CDK2/9 inhibitor, we plan to report pharmacokinetic (PK), pharmacodynamic (PD), safety and activity data from the dose escalation stage of our 065-101 study followed by initial clinical activity data from the Phase 2 proof of concept (PoC) stage. We also expect to report PK, PD, safety and activity data from the dose escalation part of our 140-101 Phase 1/2 study of plogosertib, our oral PLK1 inhibitor," said Spiro Rombotis, President and Chief Executive Officer. "Data collected to date suggest that fadraciclib and plogosertib are differentiated from other molecules in their respective classes. Furthermore, the receipt of $4.7 million in non-dilutive capital from the R&D tax credit along with existing resources supports our ongoing clinical programs."

"Both clinical programs with fadraciclib and plogosertib are progressing well and are approaching important data readouts," said Mark Kirschbaum, M.D., Chief Medical Officer. "In 065-101, we are currently recruiting patients at dose level 6A of fadraciclib with the aim of optimizing the recommended Phase 2 dosing schedule before opening the PoC stage. Our Phase 2 clinical sites are ready to enroll patients with the tumor types that appear to be most sensitive to fadraciclib treatment. With plogosertib we are recruiting patients at dose level 4. After observing unexpected efficacy at lower dose levels with three patients on treatment for three to eight cycles, we are investigating the biological rationale for this effect and how we could exploit these findings in subsequent studies. We remain enthusiastic about our clinical stage pipeline and look forward to presenting emerging data from these two programs during the year."

Key Upcoming Milestones for 2023

· Report final data from dose escalation stage and RP2D determination from the 065-101 study of oral fadraciclib in patients with advanced solid tumors and lymphoma
· First patient dosed with oral fadraciclib in Phase 2 proof-of-concept stage of 065-101 study in patients with advanced solid tumors and lymphoma
· Report Phase 1 data from 140-101 study of oral plogosertib in patients with advanced solid tumors and lymphoma
· Report interim data from initial cohorts in Phase 2 proof-of-concept stage of 065-101 study with oral fadraciclib in patients with advanced solid tumors and lymphoma

Financial Highlights

As of March 31, 2023, pro forma cash and cash equivalents totaled $16.1 million, including the $4.7 million of United Kingdom research & development tax credits received after the end of the quarter. Cash and cash equivalents as of March 31, 2023 was $11.4 million, compared to $18.3 million as of December 31, 2022. Net cash used in operating activities was $6.9 million for the three months ended March 31, 2023 compared to $6.8 million for the same period of 2022. The Company estimates that its available cash will fund currently planned programs into the first quarter of 2024.

Research and development (R&D) expenses were $5.7 million for the three months ended March 31, 2023, as compared to $5.0 million for the same period in 2022. R&D expenses relating to fadraciclib were $4.1 million for the three months ended March 31, 2023, as compared to $3.6 million for the same period in 2022 due to increased non-clinical expenditures. R&D expenses related to plogosertib were $1.4 million for the three months ended March 31, 2023, as compared to $1.1 million for the same period in 2022 due to clinical trial costs associated with the progression of the Phase 1/2 study.

General and administrative expenses for the three months ended March 31, 2023 and 2022, remained relatively flat at $1.6 million.

Total other income, net, for the three months ended March 31, 2023, was $0.2 million compared to an income of $1.3 million for the same period of the previous year. The decrease of $1.1 million for the three months ended March 31, 2023, is primarily related to royalty income received in the previous year.

United Kingdom research & development tax credits for the three months ended March 31, 2023 were $1.3 million compared to $1.1 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 March 31, 2023, was $5.8 million, compared to $4.1 million for the same period in 2022.

Conference call information:

US/Canada call: (800) 274-8461 / international call: (203) 518-9783

US/Canada archive: (800) 839-6975 / international archive: (402) 220-6061

Code for live and archived conference call is CYCCQ123. 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.