CYCC Cyclacel Pharmaceuticals Inc.

5.73
-0.05  -1%
Previous Close 5.78
Open 5.69
52 Week Low 3.12
52 Week High 11.42
Market Cap $52,911,450
Shares 9,234,110
Float 9,152,307
Enterprise Value $9,734,155
Volume 86,093
Av. Daily Volume 107,330
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Upcoming Catalysts

Drug Stage Catalyst Date
CYC140
Leukemias
Phase 1
Phase 1
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Fadraciclib (CYC065-101)
Advanced cancers
Phase 2
Phase 2
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Drug Pipeline

Drug Stage Notes
Oral fadraciclib (065-102)
Leukemia
Phase 1/2
Phase 1/2
Phase 1/2 trial to commence dosing 2H 2021.
Oral CYC140
Solid tumors
Phase 1/2
Phase 1/2
Phase 1/2 trial to commence 2H 2021.
Sapacitabine (SEAMLESS)
Acute myeloid leukemia - cancer
Phase 3
Phase 3
Noted mid-Dec 2014 that interim analysis suggests that trial will fail. Top-line data released February 23, 2017 that primary endpoint was not met. Complete remission (CR) improvement noted - secondary endpoint.

Latest News

  1. BERKELEY HEIGHTS, N.J., Sept. 08, 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 the Company will participate in three investor conferences in September.

    Presentation details are:

    • H.C. Wainwright 23rd Annual Global Investment Conference - September 13-15, 2021
         Format: On demand presentation and 1X1 meetings
         Date and Time: Available from Monday, September 13th 7am ET
         Registration Link
    • Oppenheimer Fall Healthcare Life Sciences and MedTech Summit - September 20-22, 2021
         Format: Presentation and 1X1 meetings
         Date and Time: Tuesday, September…

    BERKELEY HEIGHTS, N.J., Sept. 08, 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 the Company will participate in three investor conferences in September.

    Presentation details are:

    • H.C. Wainwright 23rd Annual Global Investment Conference - September 13-15, 2021

         Format: On demand presentation and 1X1 meetings

         Date and Time: Available from Monday, September 13th 7am ET

         Registration Link
    • Cantor Fitzgerald Global Healthcare Conference – September 27-30, 2021

         
      Format: Presentation and 1X1 meetings

         Date and Time: Thursday, September 30, 2:00 PM ET

         Webcast Link: https://wsw.com/webcast/cantor12/cycc/2064020

    For the live and archived webcast, please visit the Corporate Presentations page on the Cyclacel website at www.cyclacel.com.

    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 www.cyclacel.com.

    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 www.sec.gov. 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 
      
    Company:Paul McBarron, (908) 517-7330, pmcbarron@cyclacel.com
    Investor Relations:LifeSci Advisors, LLC, Irina Koffler, (646) 970-4681, ikoffler@lifesciadvisors.com

    © Copyright 2021 Cyclacel Pharmaceuticals, Inc. All Rights Reserved. The Cyclacel logo and Cyclacel® are trademarks of Cyclacel.



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  2. - 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…

    - 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

    • Oral fadraciclib - First three patients with advanced solid tumors dosed in the 065-101 Phase 1/2, registration-directed trial. The study includes multiple cohorts defined by histology thought to be sensitive to the drug's mechanism of action and informed by the clinical activity of fadraciclib in MCL1, MYC and/or cyclin E amplified cancers. The cohorts include breast (metastatic, hormone receptor positive, post-CDK4/6 inhibitor; HER-2 refractory; or triple negative), cholangiocarcinoma, colorectal (including KRAS mutant), endometrial, hepatocellular, ovarian cancers and certain lymphomas. The study design also includes a basket cohort which will enroll patients with relevant biomarkers to the drug's mechanism regardless of histology. Previously single agent, intravenous fadraciclib has demonstrated durable suppression of MCL1 and other mechanistically-related proteins, including cyclin E and MYC, at tolerated doses.



    • Oral CYC140 – continued progress with IND-directed activities and manufacturing of clinical trial supplies. Initial data in preclinical models show that KRAS mutant cancers are sensitive to oral CYC140 inhibition. The Company expects to begin a study in patients with solid tumors in the second half of 2021. Similar to the fadraciclib clinical program, the CYC140 Phase 1/2 study will be a registration-directed trial using a streamlined design that will first determine the recommended Phase 2 dose (RP2D) for single-agent CYC140. Once the RP2D has been established, the trial will immediately enter into a proof-of-concept, cohort stage, using a Simon 2-stage design, where single agent CYC140 will be administered to patients across multiple cohorts based upon those histologies thought to be sensitive to the drug's mechanism of action.

    Key Near-Term Business Objectives and Expected Timeline

    2H 2021

    • First patient to be dosed with oral fadraciclib in 065-102 Phase 1/2 leukemia study
    • FDA clearance of IND filing; begin oral CYC140 Phase 1/2 advanced solid tumor study

    1H 2022

    • First patient to be dosed with oral CYC140 in Phase 1/2 leukemia study
    • Phase 1 data with oral fadraciclib in advanced solid tumor 065-101 study

    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 www.cyclacel.com.

    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 www.cyclacel.com.

    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 www.sec.gov. 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

    Company:Paul McBarron, (908) 517-7330, pmcbarron@cyclacel.com
    Investor Relations:LifeSci Advisors, LLC, Irina Koffler, (646) 970-4681, ikoffler@lifesciadvisors.com

    © Copyright 2021 Cyclacel Pharmaceuticals, Inc. All Rights Reserved. The Cyclacel logo and Cyclacel® are trademarks of Cyclacel.

     
    CYCLACEL PHARMACEUTICALS, INC.
    CONSOLIDATED STATEMENTS OF OPERATIONS (LOSS)
        (In $000s, except share and per share amounts)
          
     Three Months Ended 
     June 30, 
     2020  2021 
          
    Revenues:     
    Total revenues                              -                              - 
    Operating expenses:     
    Research and development                   1,163                     4,101 
    General and administrative                   1,309                     1,999 
    Total operating expenses                   2,472                     6,100 
    Operating loss                (2,472)                 (6,100)
    Other income (expense):     
    Foreign exchange gains (losses)                         (2)                       (13)
    Interest income                           4                             4 
    Other income, net                         18                           18 
    Total other income (expense), net                         20                             9 
    Loss before taxes                (2,452)                 (6,091)
    Income tax benefit                      286                        964 
    Net loss                (2,166)                 (5,127)
    Dividend on convertible exchangeable preferred shares                      (50)                       (50)
    Beneficial conversion feature of Series B preferred stock                            -                              - 
    Net loss applicable to common shareholders$              (2,216) $              (5,177)
    Basic and diluted earnings per common share:     
    Net loss per share – basic and diluted$                (0.58) $                (0.56)
    Weighted average common shares outstanding3,850,228  9,234,110 
          





     
    CYCLACEL PHARMACEUTICALS, INC.
    CONSOLIDATED BALANCE SHEET
    (In $000s, except share, per share, and liquidation preference amounts)
              
           December 31, June 30,
           2020 2021
              
    ASSETS   
    Current assets:   
    Cash and cash equivalents$             33,406 $              43,639
    Prepaid expenses and other current assets2,063 2,564
    Total current assets35,469 46,203
        
    Property and equipment, net106 73
    Right-of-use lease asset1,227 58
    Total assets$             36,802 $              46,334
    LIABILITIES AND STOCKHOLDERS' EQUITY    
    Current liabilities:   
    Accounts payable$                   514 $                1,197
    Accrued and other current liabilities  1,972 1,921
    Total current liabilities2,486 3,118
    Lease liability1,057 -
    Total liabilities3,543 3,118
         
    Stockholders' equity   33,259 43,216
    Total liabilities and stockholders' equity   $             36,802 $              46,334
        

    SOURCE: Cyclacel Pharmaceuticals, Inc



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  3. BERKELEY HEIGHTS, N.J., Aug. 03, 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, will announce second quarter financial results and provide a business update on Wednesday, August 11, 2021. The company will host a conference call and live webcast at 4:30 p.m. Eastern Daylight Time on the same day.

    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

    BERKELEY HEIGHTS, N.J., Aug. 03, 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, will announce second quarter financial results and provide a business update on Wednesday, August 11, 2021. The company will host a conference call and live webcast at 4:30 p.m. Eastern Daylight Time on the same day.

    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 replay webcast, please visit the Corporate Presentations page on the Cyclacel website at www.cyclacel.com.

    BTIG Virtual Biotechnology Conference, August 9, 2021

    Fireside chat at 9:00 am EDT

    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 www.cyclacel.com.

    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 www.sec.gov. 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 
    Company:                Paul McBarron, (908) 517-7330, pmcbarron@cyclacel.com
    Investor Relations: LifeSci Advisors, LLC, Irina Koffler, (646) 970-4681, ikoffler@lifesciadvisors.com

    © Copyright 2021 Cyclacel Pharmaceuticals, Inc. All Rights Reserved. The Cyclacel logo and Cyclacel® are trademarks of Cyclacel.



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  4. BERKELEY HEIGHTS, N.J., July 13, 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, announced dosing of the first patient in the Company's multi-cohort Phase 1/2 study of oral fadraciclib in patients with advanced solid tumors.

    "Advancing oral fadraciclib, our lead candidate, into this Phase 1/2 trial, represents a key clinical milestone and corporate objective for our team," said Spiro Rombotis, Cyclacel's President and Chief Executive Officer. "This is the first of four streamlined Phase 1/2 studies we plan to open over the coming months as we expand our clinical programs to…

    BERKELEY HEIGHTS, N.J., July 13, 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, announced dosing of the first patient in the Company's multi-cohort Phase 1/2 study of oral fadraciclib in patients with advanced solid tumors.

    "Advancing oral fadraciclib, our lead candidate, into this Phase 1/2 trial, represents a key clinical milestone and corporate objective for our team," said Spiro Rombotis, Cyclacel's President and Chief Executive Officer. "This is the first of four streamlined Phase 1/2 studies we plan to open over the coming months as we expand our clinical programs to evaluate the potential of fadraciclib and CYC140, our oral PLK1 inhibitor, first in solid tumors and lymphomas and then in leukemias. We look forward to providing periodic updates on our clinical progress and data from these open-label studies."

    "We are pleased to have dosed the first patient in this study and are delighted by the enthusiasm and strong interest from current and prospective investigators," said Mark Kirschbaum M.D., Senior Vice President & Chief Medical Officer of Cyclacel. "The study has initially opened at City of Hope and MD Anderson Cancer Center with more sites to join later on. We are building an excellent network of participating institutions both in terms of clinical and scientific expertise. In previous studies with single agent, intravenous fadraciclib we have observed durable suppression of MCL1 and other mechanistically-related proteins, including cyclin E and MYC, at tolerated doses. In addition, a patient with MCL1 amplified, advanced endometrial cancer experienced deep PR and 100% shrinkage of her target tumor lesions on single agent fadraciclib treatment. We are excited to begin mid-stage development of fadraciclib with the objective of registration-enabling outcomes and offering a new treatment option for patients with advanced solid tumors or lymphomas."

    "Based upon prior clinical activity shown to date, further exploration of this novel CDK2/9 inhibitor is warranted across a number of solid tumor histologies," said Miguel Villalona-Calero, M.D., co-leader of the Developmental Cancer Therapeutics Program and Professor, Department of Medical Oncology & Therapeutics Research at the City of Hope, a world-renowned, independent research and treatment center for cancer, diabetes and other life-threatening diseases. "We look forward to enrolling patients in this trial and evaluating the potential treatment benefit of this experimental therapy both as a single agent and in combinations."

    The Phase 1/2 registration-directed trial (CYC065-101) uses a streamlined design and will first determine the recommended Phase 2 dose (RP2D) for single-agent, oral fadraciclib. Once RP2D has been established, the trial will immediately enter into proof-of-concept, cohort stage, using a Simon 2-stage design, where single agent fadraciclib will be administered to patients in up to eight cohorts defined by histology thought to be sensitive to the drug's mechanism of action and informed by the clinical activity of fadraciclib in previous studies. The cohorts will include patients with breast cancer (selected for metastatic, hormone receptor positive, HER-2 negative, post-CDK4/6 inhibitor; HER-2 refractory; or triple negative), colorectal (including KRAS mutant), endometrial, hepatocellular and ovarian cancers, as well as certain lymphomas. An additional basket cohort will enroll patients with biomarkers relevant to the drug's mechanism, including MCL1, MYC and cyclin E, regardless of histology. The protocol allows for expansion of a cohort based on response which may allow acceleration of the clinical development and registration plan for fadraciclib.

    About Cyclin-Dependent Kinases and Fadraciclib

    Cyclin-dependent kinases (CDKs) are critical for cell cycle control and transcriptional regulation. Dysregulated CDKs have been linked to the cancer hallmarks of uncontrolled proliferation and increased cancer cell survival. Fadraciclib, a next generation CDK inhibitor, is a highly selective, potent, orally and intravenously available, inhibitor of CDK2 and CDK9. CDK2 drives cell cycle transitions and CDK9 regulates transcription of genes through phosphorylation of the carboxy-terminal domain (CTD) of RNA polymerase II (RNAP II). By inhibiting CDK2 and CDK9 fadraciclib causes apoptotic death of cancer cells at sub-micromolar concentrations.

    Preclinical data suggest that fadraciclib may benefit patients with certain cyclin E-addicted or MYC-amplified solid tumors, including certain forms of breast cancer, neuroblastoma, ovarian cancer, uterine serous carcinoma and adult and pediatric hematological malignancies, such as ALL, AML, B-cell lymphoma, CLL, and multiple myeloma. Similarly to FDA-approved CDK4/6 inhibitors, fadraciclib may be useful in combination with other anticancer drugs, including HER2 inhibitors, such as trastuzumab, or BCL2 inhibitors, such as venetoclax.

    In a prior Phase 1 open-label trial (CYC065-01), patients with high copy CCNE (cyclin E), MYC or MCL1 showed sensitivity to intravenously-administered, single-agent fadraciclib. A heavily pretreated patient with MCL1 amplified endometrial cancer achieved a radiographically confirmed partial response (PR) after a month and a half on fadraciclib. This patient continues on therapy for almost two years and reduction in her target tumor lesions has reached 100%. An additional patient with cyclin E amplified ovarian cancer achieved stable disease with 29% shrinkage in her target tumor lesions.

    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 www.cyclacel.com.

    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 www.sec.gov. 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

    Company:Paul McBarron, (908) 517-7330, pmcbarron@cyclacel.com
    Investor Relations:Irina Koffler, LifeSci Advisors, LLC, (646) 970-4681, ikoffler@lifesciadvisors.com

    © Copyright 2021 Cyclacel Pharmaceuticals, Inc. All Rights Reserved. The Cyclacel logo and Cyclacel® are trademarks of Cyclacel.



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  5. 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:

    Date: Wednesday, July 14
    Time: 10:30-10:55 am EDT
    Location: Virtual; Track 1

    Investor registration: click here

    The webcast will be archived for 90 days and can be found on the Cyclacel website at www.cyclacel.com

    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:

    Date: Wednesday, July 14
    Time: 10:30-10:55 am EDT
    Location: Virtual; Track 1

    Investor registration: click here

    The webcast will be archived for 90 days and can be found on the Cyclacel website at www.cyclacel.com.

    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 www.cyclacel.com.

    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 www.sec.gov. 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

    Company:Paul McBarron, (908) 517-7330, pmcbarron@cyclacel.com
    Investor Relations:LifeSci Advisors, LLC, Irina Koffler, (646) 970-4681, ikoffler@lifesciadvisors.com

    © Copyright 2021 Cyclacel. All Rights Reserved. The Cyclacel logo and Cyclacel® are trademarks of Cyclacel.



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