TKM-PLK1

- Announces First Patients with Solid Tumors Dosed with Oral Fadraciclib -- Additional Phase 1/2 Trials for Fadraciclib and CYC140 Expected to Follow -- Cash Runway to Early 2023 -- Conference Call Scheduled August 11, 2021 at 4:30 p.m. ET - BERKELEY HEIGHTS, N.J., Aug. 11, 2021 (GLOBE NEWSWIRE) -- Cyclacel Pharmaceuticals, Inc. (NASDAQ: CYCC, NASDAQ: CYCCP; "Cyclacel" or the "Company"), a biopharmaceutical company developing innovative medicines based on cancer cell biology, today reported its financial results for the second quarter 2021. The quarter’s business highlights included an update on the Company’s progress with fadraciclib and CYC140, Cyclacel's novel CDK2/9 and PLK1 inhibitors, respectively. “After announcing In July that the first patient had been dosed with oral fadraciclib, two additional patients with advanced solid tumors have been treated, completing enrolment of the first dose level,” said Spiro Rombotis, President and Chief Executive Officer. “We are encouraged by investigator interest in our fadraciclib 065-101 solid tumor study. In earlier clinical studies fadraciclib has demonstrated single-agent activity, including durable PR. We believe that fadraciclib is a leading, transcriptionally-active CDK inhibitor with a differentiated product profile. Pipeline momentum will continue to build with the planned opening of protocol 065-102, an oral fadraciclib study in patients with hematological malignancies, and later with the initiation of two similar protocols in solid tumors and hematological malignancies for our novel PLK1 inhibitor, CYC140. The second half of 2021 is an exciting period for Cyclacel, as we expand our clinical programs and increase our visibility as an oncology leader focused on cell cycle inhibition for the treatment of cancer. We look forward to reporting further updates as data from these studies become available.” Key Corporate Highlights Key Near-Term Business Objectives and Expected Timeline 2H 2021 1H 2022 Financial Highlights As of June 30, 2021, cash and cash equivalents totaled $43.6 million, compared to $47.8 million as of March 31, 2021. The decrease of $4.2 million was primarily due to net cash used in operating activities. The Company estimates that the cash resources will fund currently planned programs through early 2023. Research and development expenses were $4.1 million for the three months ended June 30, 2021 as compared to $1.2 million for the same period in 2020. Research and development (R&D) expenses relating to fadraciclib increased by approximately $1.9 million for the three months ended June 30, 2021 with the start of the CYC065-101 study of fadraciclib in solid tumors and preparations for opening the 065-102 study of fadraciclib in leukemias. Additionally, R&D expenses related to CYC140 increased $1.0 million for the quarter as IND-directed activities are approaching completion and clinical trial supplies are being manufactured. General and administrative expenses for the three months ended June 30, 2021 were $2.0 million, compared to $1.3 million for the same period of the previous year due to costs of approximately $0.4 million related to exiting a long-term facility lease, increased legal and professional expenses and recruitment costs. United Kingdom research & development tax credits were $1.0 million for the three months ended June 30, 2021, as compared to $0.3 million for the same period in 2020 due to the increase in R&D expenditure. Net loss for the three months ended June 30, 2021 was $5.1 million, compared to $2.2 million for the same period in 2020. Conference call information: Conference ID: CYCCQ221 US call: (866) 342-8591/ international call: +1 (203) 518-9713 Replay: US: (800) 839-5109 / international archive: +1 (402) 220-2688 Code for live and replay conference call is CYCCQ221 Webcast link. For the live and archived webcast, please visit the Corporate Presentations page on the Cyclacel website at . About Cyclacel Pharmaceuticals, Inc. Cyclacel is a clinical-stage, biopharmaceutical company developing innovative cancer medicines based on cell cycle, transcriptional regulation and mitosis biology. The transcriptional regulation program is evaluating fadraciclib, a CDK2/9 inhibitor, and the anti-mitotic program CYC140, a PLK1 inhibitor, in patients with both solid tumors and hematological malignancies. Cyclacel's strategy is to build a diversified biopharmaceutical business based on a pipeline of novel drug candidates addressing oncology and hematology indications. For additional information, please visit . Forward-looking Statements This news release contains certain forward-looking statements that involve risks and uncertainties that could cause actual results to be materially different from historical results or from any future results expressed or implied by such forward-looking statements. Such forward-looking statements include statements regarding, among other things, the efficacy, safety and intended utilization of Cyclacel's product candidates, the conduct and results of future clinical trials, plans regarding regulatory filings, future research and clinical trials and plans regarding partnering activities. Factors that may cause actual results to differ materially include the risk that product candidates that appeared promising in early research and clinical trials do not demonstrate safety and/or efficacy in larger-scale or later clinical trials, trials may have difficulty enrolling, Cyclacel may not obtain approval to market its product candidates, the risks associated with reliance on outside financing to meet capital requirements, and the risks associated with reliance on collaborative partners for further clinical trials, development and commercialization of product candidates. You are urged to consider statements that include the words "may," "will," "would," "could," "should," "believes," "estimates," "projects," "potential," "expects," "plans," "anticipates," "intends," "continues," "forecast," "designed," "goal," or the negative of those words or other comparable words to be uncertain and forward-looking. For a further list and description of the risks and uncertainties the Company faces, please refer to our most recent Annual Report on Form 10-K and other periodic and other filings we file with the Securities and Exchange Commission and are available at . Such forward-looking statements are current only as of the date they are made, and we assume no obligation to update any forward-looking statements, whether as a result of new information, future events or otherwise. Contacts © Copyright 2021 Cyclacel Pharmaceuticals, Inc. All Rights Reserved. The Cyclacel logo and Cyclacel® are trademarks of Cyclacel. SOURCE: Cyclacel Pharmaceuticals, Inc

BERKELEY HEIGHTS, N.J., July 07, 2021 (GLOBE NEWSWIRE) -- Cyclacel Pharmaceuticals, Inc. (NASDAQ: CYCC, NASDAQ: CYCCP; "Cyclacel" or the "Company"), a biopharmaceutical company developing innovative medicines based on cancer cell biology, today announced that it will participate in the Ladenburg Thalmann’s Virtual 2021 Healthcare Conference held July 13-14, 2021. Spiro Rombotis, President & Chief Executive Officer, will present an overview of Cyclacel’s business followed by an analyst-led fireside chat. Presentation Information: Investor registration: click here The webcast will be archived for 90 days and can be found on the Cyclacel website at . About Cyclacel Pharmaceuticals, Inc. Cyclacel is a clinical-stage, biopharmaceutical company developing innovative cancer medicines based on cell cycle, transcriptional regulation and mitosis biology. The transcriptional regulation program is evaluating fadraciclib, a CDK2/9 inhibitor, and the anti-mitotic program CYC140, a PLK1 inhibitor, in patients with both solid tumors and hematological malignancies. Cyclacel's strategy is to build a diversified biopharmaceutical business based on a pipeline of novel drug candidates addressing oncology and hematology indications. For additional information, please visit . Forward-looking Statements This news release contains certain forward-looking statements that involve risks and uncertainties that could cause actual results to be materially different from historical results or from any future results expressed or implied by such forward-looking statements. Such forward-looking statements include statements regarding, among other things, the efficacy, safety and intended utilization of Cyclacel’s product candidates, the conduct and results of future clinical trials, plans regarding regulatory filings, future research and clinical trials and plans regarding partnering activities. Factors that may cause actual results to differ materially include the risk that product candidates that appeared promising in early research and clinical trials do not demonstrate safety and/or efficacy in larger-scale or later clinical trials, trials may have difficulty enrolling, Cyclacel may not obtain approval to market its product candidates, the risks associated with reliance on outside financing to meet capital requirements, the potential effects of the COVID-19 pandemic, and the risks associated with reliance on collaborative partners for further clinical trials, development and commercialization of product candidates. You are urged to consider statements that include the words "may," "will," "would," "could," "should," "believes," "estimates," "projects," "potential," "expects," "plans," "anticipates," "intends," "continues," "forecast," "designed," "goal," or the negative of those words or other comparable words to be uncertain and forward-looking. For a further list and description of the risks and uncertainties the Company faces, please refer to our most recent Annual Report on Form 10-K and other periodic and other filings we file with the Securities and Exchange Commission and are available at . Such forward-looking statements are current only as of the date they are made, and we assume no obligation to update any forward-looking statements, whether as a result of new information, future events or otherwise. Contacts © Copyright 2021 Cyclacel. All Rights Reserved. The Cyclacel logo and Cyclacel® are trademarks of Cyclacel.