CYCC Cyclacel Pharmaceuticals Inc.

3.74
-0.03  -1%
Previous Close 3.77
Open 3.73
52 Week Low 3.23
52 Week High 19.59738
Market Cap $18,191,300
Shares 4,863,984
Float 4,821,312
Enterprise Value $-5,923,781
Volume 151,770
Av. Daily Volume 235,939
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Upcoming Catalysts

Drug Stage Catalyst Date
Fadraciclib CYC065
Advanced cancers
Phase 1
Phase 1
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Sapacitabine in combination with olaparib
BRCA mutant breast cancer
Phase 1/2
Phase 1/2
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CYC140
Leukemias
Phase 1
Phase 1
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Fadraciclib and venetoclax
Chronic lymphocytic leukemia (CLL)
Phase 1
Phase 1
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Sapacitabine and Venetoclax
Relapsed or refractory Acute myeloid leukemia or myelodysplastic syndrome (MDS)
Phase 1/2
Phase 1/2
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Drug Pipeline

Drug Stage Notes
Sapacitabine and seliciclib
BRCA mutant breast cancer
Phase 1
Phase 1
Phase 1 data at AACR April 1, 2019. 2/20 partial responses (PRs).
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., Aug. 12, 2020 (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 2020 and business highlights, including an update on its progress with fadraciclib, Cyclacel's novel CDK2/9 inhibitor.

    The Company's net loss applicable to common shareholders for the three months ended June 30, 2020 was $2.2 million. As of June 30, 2020, cash and cash equivalents totaled $25.3 million. Based on current spending, the Company estimates it has sufficient resources to fund planned operations, including research and development…

    BERKELEY HEIGHTS, N.J., Aug. 12, 2020 (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 2020 and business highlights, including an update on its progress with fadraciclib, Cyclacel's novel CDK2/9 inhibitor.

    The Company's net loss applicable to common shareholders for the three months ended June 30, 2020 was $2.2 million. As of June 30, 2020, cash and cash equivalents totaled $25.3 million. Based on current spending, the Company estimates it has sufficient resources to fund planned operations, including research and development, through the end of 2022.

    "We believe fadraciclib is establishing a leadership position among MCL1 suppressing compounds in development. Our recent, peer-reviewed publication elaborates the mechanistic rationale for fadraciclib as an anti-cancer therapy signifying the benefits of inhibiting CDK2 and CDK9, two complementary cancer pathways," said Spiro Rombotis, President and Chief Executive Officer. "We continue to be encouraged by observations of deep partial response and prolonged stable disease with tumor shrinkage as an intravenously administered monotherapy in patients with advanced solid tumors and antileukemic activity in combination with venetoclax. In parallel with evaluating fadraciclib in certain leukemias, we are executing a precision medicine strategy to evaluate the compound in patients with solid tumors with study enrollment expected to begin by the first quarter of 2021. As the global pandemic continues to unfold, our priorities are to ensure patient and employee safety and support efforts to stem COVID-19 disease as part of our corporate social responsibility. Despite the challenges we remain committed to our strategy of building an innovative pipeline addressing the rising problem of cancer resistance and achieving our clinical milestones to drive shareholder value."

    Key Corporate Highlights

    • Announced publication of a peer-reviewed study of fadraciclib, in PLOS ONE. The publication, authored by scientists from Cyclacel and The Institute of Cancer Research, London, describes the discovery of fadraciclib and shows its ability to target CDK2 and CDK9, leading to broad therapeutic potential.

       
    • CYC065-01 Phase 1 part 2 single agent i.v. As previously reported a heavily pretreated patient with MCL1 amplified endometrial cancer achieved a radiographically confirmed partial response (PR) after a month and a half on fadraciclib at 213mg. This patient continues on therapy for more than a year and reduction in her target tumor lesions is 83%. An additional patient with cyclin E amplified ovarian cancer achieved stable disease with 29% tumor shrinkage after approximately four months at 213mg. We have submitted data for publication at a cancer conference later in the year.

       
    • Based on data thus far, we are designing a Phase 1/2 precision medicine study to further evaluate fadraciclib as monotherapy and in combinations in patients with advanced solid tumors.

       
    • CYC065-01 Phase 1 part 3 single agent p.o. - Initial data from an oral capsule formulation of fadraciclib given once daily to four patients with advanced solid tumors demonstrated a predictable pharmacokinetic profile closely overlapping the intravenous form with encouraging exposure levels.

       
    • CYC065-03 Phase 1 fadraciclib i.v. and venetoclax p.o. in AML/MDS - We have dosed 11 heavily pretreated patients with relapsed/refractory (R/R) AML in five dose levels up to 200 mg/m2 of fadraciclib in combination with venetoclax. Evidence of anticancer activity has been observed in four out of eleven patients treated. Preclinical data in AML suggest that targeting both MCL1 and BCL2 may be more beneficial than inhibiting either protein alone.

       
    • CYC065-02 Phase 1 fadraciclib i.v. and venetoclax p.o. in CLL - We have dosed 5 patients with R/R CLL in four dose levels up to 150 mg/m2 of fadraciclib in combination with venetoclax. Evidence of anticancer activity has been observed in two patients who achieved MRD negativity on the combination. Preclinical data suggest that targeting both BCL2 and MCL1 in CLL may be more beneficial than single agent treatment in this setting as well.

       
    • CYC682-11 Phase 1 part 2 sapacitabine p.o. and venetoclax p.o. - We have enrolled 12 patients in a dose escalation study in our DNA Damage Response (DDR) program evaluating an oral combination of sapacitabine and venetoclax in patients with R/R AML/MDS. Two patients, previously treated with combination therapies including hypomethylating agents, have achieved 5 and 6 cycles of treatment respectively. Sapacitabine is a nucleoside analogue that is active in AML and MDS R/R to prior therapy such as cytarabine or hypomethylating agents. Preclinical data demonstrated synergy of sapacitabine with BCL2 inhibition, which may offer an effective, oral treatment regimen for patients who have failed front-line therapy.

       
    • CYC140-01 Phase 1 CYC140 i.v. - We have enrolled 6 patients in our first-in-human, dose escalation study evaluating CYC140 in patients with advanced leukemias. CYC140 is a small molecule, selective polo-like-kinase 1 (PLK1) inhibitor that has demonstrated potent and selective target inhibition and high activity in xenograft models of human cancers. In addition to hematological malignancies we are evaluating studies of CYC140 in solid tumors.

    More information on our clinical trials can be found here.

    Key Business Objectives

    • Report updated fadraciclib Phase 1 safety and efficacy data with frequent i.v. dosing schedule in patients with advanced solid cancers;
    • Report initial safety and PK data from Phase 1 study of fadraciclib oral formulation;
    • Treat first patient in fadraciclib Phase 1/2 precision medicine study;
    • Report initial data from fadraciclib-venetoclax Phase 1 study in R/R AML/MDS & CLL;
    • Report initial data from sapacitabine-venetoclax Phase 1 study in R/R AML/MDS;
    • Report initial data from CYC140 Phase 1 first-in-human study in R/R leukemias; and
    • Report data from Phase 1b/2 sapacitabine-olaparib IST in BRCA mutant metastatic breast cancer when reported by the investigators.

    Financial Highlights

    As of June 30, 2020, cash and cash equivalents totaled $25.3 million, compared to $11.9 million as of December 31, 2019. The increase of $13.4 million was primarily due to net proceeds of $18.3 million from an equity financing in April 2020 and net cash used in operating activities of $4.7 million. There were no revenues for each of the three months ended June 30, 2020 and 2019.

    Research and development expenses were $1.2 million for each of the three months ended June 30, 2020 and 2019. Research and development expenses relating to transcriptional regulation increased by approximately $0.2 million for the three months ended June 30, 2020 as we continue to progress the clinical evaluation of fadraciclib.

    General and administrative expenses for the three months ended June 30, 2020 were $1.3 million, compared to $1.2 million for the same period of the previous year.

    Total other income, net, for the three months ended June 30, 2020 was $20,000, compared to $0.2 million for the same period of the previous year. The decrease of approximately $0.2 million for the three months ended June 30, 2020 is primarily related to income received under an Asset Purchase Agreement with Thermo Fisher Scientific Inc.

    United Kingdom research & development tax credits were $0.3 million for each of the three months ended June 30, 2020 and 2019.

    Net loss for the three months ended June 30, 2020 was $2.2 million compared to $1.8 million for the same period in 2019.

    The Company estimates that cash resources of $25.3 million as of June 30, 2020 will fund currently planned programs through 2022.

    Conference call information:

    US/Canada call: (877) 493-9121 / international call: (973) 582-2750 

    US/Canada archive: (800) 585-8367 / international archive: (404) 537-3406 

    Code for live and archived conference call is 2477369.

    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. 

    About Cyclacel Pharmaceuticals, Inc.

    Cyclacel Pharmaceuticals is a clinical-stage biopharmaceutical company developing innovative cancer medicines based on cell cycle, transcriptional regulation and DNA damage response biology. The transcriptional regulation program is evaluating fadraciclib as a single agent in solid tumors and in combination with venetoclax in patients with relapsed or refractory AML/MDS and CLL. The DNA damage response program is evaluating an oral combination of sapacitabine and venetoclax in patients with relapsed or refractory AML/MDS. An investigator-sponsored trial (IST) is evaluating an oral combination of sapacitabine and olaparib in patients with BRCA mutant breast cancer. The anti-mitotic program is evaluating CYC140, a PLK1 inhibitor, in advanced leukemias/MDS patients. Cyclacel's strategy is to build a diversified biopharmaceutical business focused in hematology and oncology based on a pipeline of novel drug candidates. 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, 



    Investor Relations: Russo Partners LLC, Jan Medina, (646) 942-5632,                

    © Copyright 2020 Cyclacel Pharmaceuticals, Inc. All Rights Reserved. The Cyclacel logo and Cyclacel® are trademarks of Cyclacel Pharmaceuticals, Inc.



    CYCLACEL PHARMACEUTICALS, INC.

     CONSOLIDATED STATEMENTS OF
    OPERATIONS (LOSS)

    (In $000s, except share and per share amounts)

            Three Months Ended
            June 30,
             2019   2020 
               
    Revenues:     
    Total revenues   -   - 
    Operating expenses:    
     Research and development  1,153   1,163 
     General and administrative  1,184   1,309 
    Total operating expenses  2,337   2,472 
    Operating loss  (2,337)  (2,472)
    Other income (expense):    
     Foreign exchange gains (losses)  21   (2)
     Interest income  56   4 
     Other income, net  170   18 
      Total other income (expense), net  247   20 
    Loss before taxes  (2,090)  (2,452)
    Income tax benefit  307   286 
    Net loss    (1,783)  (2,166)
    Dividend on convertible exchangeable preferred shares  (50)  (50)
    Net loss applicable to common shareholders $(1,833) $(2,216)
    Basic and diluted earnings per common share:    
    Net loss per share – basic and diluted $(2.13) $(0.58)
    Weighted average common shares outstanding  859,998   3,850,228 
               



    CYCLACEL PHARMACEUTICALS, INC.

    CONSOLIDATED BALANCE SHEET

    (In $000s, except share, per share, and liquidation preference amounts)

       December 31, June 30,
       2019 2020
          
    ASSETS   
    Current assets:   
     Cash and cash equivalents$11,885 $25,342
     Prepaid expenses and other current assets 2,132  2,591
      Total current assets 14,017  27,933
          
    Property and equipment, net 27  20
    Right-of-use lease asset 1,264  1,218
      Total assets$15,308 $29,171
    LIABILITIES AND STOCKHOLDERS' EQUITY    
    Current liabilities:   
     Accounts payable$890 $342
     Accrued and other current liabilities 1,530  1,170
      Total current liabilities 2,420  1,512
    Lease liability 1,191  1,081
    Other liabilities -  -
      Total liabilities 3,611  2,593
    Stockholders' equity 11,697  26,578
     Total liabilities and stockholders' equity$15,308 $29,171
          

    SOURCE: Cyclacel Pharmaceuticals, Inc.

     

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  2. BERKELEY HEIGHTS, N.J., Aug. 05, 2020 (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 2020 financial results on Wednesday, August 12, 2020. 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: 

    US/Canada call: (877) 493-9121 / international call: (973) 582-2750 

    US/Canada archive: (800) 585-8367 / international archive: (404) 537-3406 

    Code for live and archived conference call is 2477369.

    For the live and archived webcast, please visit the Corporate Presentations…

    BERKELEY HEIGHTS, N.J., Aug. 05, 2020 (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 2020 financial results on Wednesday, August 12, 2020. 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: 

    US/Canada call: (877) 493-9121 / international call: (973) 582-2750 

    US/Canada archive: (800) 585-8367 / international archive: (404) 537-3406 

    Code for live and archived conference call is 2477369.

    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. 

    About Cyclacel Pharmaceuticals, Inc.

    Cyclacel Pharmaceuticals is a clinical-stage biopharmaceutical company developing innovative cancer medicines based on cell cycle, transcriptional regulation and DNA damage response biology. The transcriptional regulation program is evaluating fadraciclib as a single agent in solid tumors and in combination with venetoclax in patients with relapsed or refractory AML/MDS and CLL. The DNA damage response program is evaluating an oral combination of sapacitabine and venetoclax in patients with relapsed or refractory AML/MDS. An investigator-sponsored trial (IST) is evaluating an oral combination of sapacitabine and olaparib in patients with BRCA mutant breast cancer. The anti-mitotic program is evaluating CYC140, a PLK1 inhibitor, in advanced leukemias/MDS patients. Cyclacel's strategy is to build a diversified biopharmaceutical business focused in hematology and oncology based on a pipeline of novel drug candidates. 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 for Cyclacel Pharmaceuticals, Inc.

    Company: Paul McBarron, (908) 517-7330,

    Investor Relations: Russo Partners LLC, Jan Medina, (646) 942-5632, 

    © Copyright 2020 Cyclacel Pharmaceuticals, Inc. All Rights Reserved. The Cyclacel logo and Cyclacel® are trademarks of Cyclacel Pharmaceuticals, Inc. 

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  3. -- Characterization of fadraciclib published in peer-reviewed journal shows specificity against

    CDK2 and CDK9 and enablement of apoptosis of cancer cells driven by MCL1, cyclin E and/or MYC –

    -- Data builds on growing body of evidence indicating the promise of dual CDK2/9 inhibition --

    BERKELEY HEIGHTS, N.J. and DUNDEE, United Kingdom, July 13, 2020 (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 publication of a peer-reviewed study of fadraciclib, in PLOS ONE. The publication, authored by scientists from Cyclacel and The Institute of Cancer Research, London, describes…

    -- Characterization of fadraciclib published in peer-reviewed journal shows specificity against

    CDK2 and CDK9 and enablement of apoptosis of cancer cells driven by MCL1, cyclin E and/or MYC –

    -- Data builds on growing body of evidence indicating the promise of dual CDK2/9 inhibition --

    BERKELEY HEIGHTS, N.J. and DUNDEE, United Kingdom, July 13, 2020 (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 publication of a peer-reviewed study of fadraciclib, in PLOS ONE. The publication, authored by scientists from Cyclacel and The Institute of Cancer Research, London, describes the discovery of fadraciclib and shows its ability to target CDK2 and CDK9, leading to broad therapeutic potential.

    "The published findings strengthen the mechanistic rationale for fadraciclib's potential as an anti-cancer therapy. Building upon previous research in CDK pathways, including the roles of cyclin E, MCL1 and MYC overexpression, the paper highlights the benefits of inhibiting both CDK2 and CDK9, two complementary cancer pathways," said Spiro Rombotis, President and Chief Executive Officer of Cyclacel. "Independent findings reported at the ASCO20 Virtual Scientific Program corroborate the attractiveness of this dual targeting approach. Based on recently disclosed clinical data fadraciclib is establishing a leadership position among apoptosis enabling compounds in clinical development. We are encouraged by observations of single agent anticancer activity in our clinical studies. Initial clinical data with oral fadraciclib show concordance with intravenous pharmacokinetics. In parallel with evaluating fadraciclib in patients with acute myeloid leukaemia (AML) and myelodysplastic syndromes (MDS), we are executing a precision medicine strategy to evaluate fadraciclib in patients with solid tumors, with study enrollment expected to begin by Q1 2021."

    "These exciting new findings revealing fadraciclib's chemical structure and describing its relevant anti-cancer properties, reflect the highly productive collaboration of ICR with Cyclacel to discover and develop innovative cancer treatments," said Professor Paul Workman, FMedSci, FRS, study co-author and Chief Executive and President, The Institute of Cancer Research, London, UK. "As a potent and selective inhibitor of CDK2 and CDK9, we believe our cumulative findings to-date support fadraciclib's ability to address key cancer pathways in solid tumors and leukaemias, indicating its potential as a new targeted anti-cancer therapy."

    Cyclin-dependent kinases (CDKs) exist in many isoforms and as key cell cycle regulators can play a critical role in cancer growth. This preclinical characterization of fadraciclib includes its potency and selectivity against CDK2 and CDK9 in vitro and in a broad range of cancer cell lines including AML, breast and colorectal. Further in vivo efficacy was demonstrated in leukemia xenograft models.

    Experimental results support fadraciclib's anti-cancer activity through CDK2/9 inhibition. In breast cancer cell lines, short-pulse treatment with fadraciclib showed preferential activity against transformed cells over normal cells. This finding supports the compound's potential benefit in cancers addicted to cyclin E which can be rationally targeted by CDK2 inhibition. In AML models, fadraciclib was effective in inhibiting CDK9 and suppressing the MCL1 protein to induce apoptosis or programmed cell death of leukemia cells. Fadraciclib also demonstrated synergy with BCL2 inhibitors such as venetoclax in AML cells. In subcutaneous mouse xenograft models of AML and MLLr-AML, nearly 100% tumor growth inhibition was achieved with oral administration of fadraciclib at pharmacological doses.

    Publication Details

    Title: Fadraciclib (CYC065), a novel CDK inhibitor, targets key pro-survival and oncogenic pathways in cancer

    Publication Date: July 9, 2020

    URL: https://doi.org/10.1371/journal.pone.0234103

    About Cyclin-Dependent Kinases and Fadraciclib

    Cyclin-dependent kinases (CDKs) are critical for cell cycle regulation and transcriptional elongation. Dysregulated CDKs have been linked to the cancer hallmarks of uncontrolled proliferation and increased survival. Fadraciclib (CYC065) is a potent orally and intravenously available inhibitor of CDK2 and CDK9. CDK9 regulates transcription of genes through phosphorylation of RNA polymerase II (RNAP II) C-terminal domain (CTD). Inhibition of CDK9 by fadraciclib suppresses CDK9-dependent gene expression and reduces the level of MCL1, a key anti-apoptotic protein.

    Fadraciclib is in an ongoing Phase 1, first-in-human study in patients with advanced solid tumors. In this all-comer study, target engagement and durable suppression of the MCL1 biomarker were observed after a single dose of fadraciclib. Tumor shrinkage and stable disease were observed in five patients with cyclin E, MCL1 or MYC amplified advanced cancers. In the ongoing part 2 of the study evaluating a more intensive dosing regimen, a durable partial response has been observed in a heavily pretreated patient with MCL1-amplified endometrial cancer. Fadraciclib is also being evaluated in Phase 1 combination studies with venetoclax in relapsed or refractory CLL and in relapsed or refractory AML or MDS. Preclinical data suggest that fadraciclib may benefit patients with adult and pediatric hematological malignancies such as CLL, AML, ALL, B-cell lymphomas, multiple myeloma and certain cyclin E-addicted or MYC-amplified solid tumors, including certain forms of breast cancer, neuroblastoma, ovarian cancer and uterine serous carcinoma.

    About Cyclacel Pharmaceuticals, Inc.

    Cyclacel Pharmaceuticals is a clinical-stage biopharmaceutical company developing innovative cancer medicines based on cell cycle, transcriptional regulation and DNA damage response biology. The transcriptional regulation program is evaluating fadraciclib as a single agent in solid tumors and in combination with venetoclax in patients with relapsed or refractory AML/MDS and CLL. The DNA damage response program is evaluating an oral combination of sapacitabine and venetoclax in patients with relapsed or refractory AML/MDS. An investigator-sponsored trial (IST) is evaluating an oral combination of sapacitabine and olaparib in patients with BRCA mutant breast cancer. The anti-mitotic program is evaluating CYC140, a PLK1 inhibitor, in advanced leukemias/MDS patients. Cyclacel's strategy is to build a diversified biopharmaceutical business focused in hematology and oncology based on a pipeline of novel drug candidates. 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, 
    Investor Relations:Russo Partners LLC, Jan Medina, (646) 942-5632,

    © Copyright 2020 Cyclacel Pharmaceuticals, Inc. All Rights Reserved. The Cyclacel logo and Cyclacel® are trademarks of Cyclacel Pharmaceuticals, Inc.

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  4. - Conference Call Scheduled May 12, 2020 at 4:30 p.m. ET -

    - Following Recent Financing Cash Runway to End of 2022 -

    BERKELEY HEIGHTS, N.J., May 12, 2020 (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 first quarter 2020 and business highlights, including an update on its progress with fadraciclib, Cyclacel's novel CDK inhibitor. The Company's net loss applicable to common shareholders for the three months ended March 31, 2020 was $1.3 million. As of March 31, 2020, cash and cash equivalents totaled $8.9 million. Following net proceeds of $18.4 million…

    - Conference Call Scheduled May 12, 2020 at 4:30 p.m. ET -

    - Following Recent Financing Cash Runway to End of 2022 -

    BERKELEY HEIGHTS, N.J., May 12, 2020 (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 first quarter 2020 and business highlights, including an update on its progress with fadraciclib, Cyclacel's novel CDK inhibitor. The Company's net loss applicable to common shareholders for the three months ended March 31, 2020 was $1.3 million. As of March 31, 2020, cash and cash equivalents totaled $8.9 million. Following net proceeds of $18.4 million from an equity financing in April 2020, pro forma cash and cash equivalents total $27.3 million. Based on current spending, the Company estimates it has sufficient resources to fund planned operations, including research and development, to the end of 2022.

    "The global pandemic is creating uncertainty in every business sector and it is clear that we need novel, science-based solutions to emerge from the crisis," said Spiro Rombotis, President and Chief Executive Officer. "While our priorities are ensuring patient safety and addressing our social responsibility, we remain committed to our business strategy of building an innovative pipeline addressing the rising problem of cancer resistance. Fadraciclib is establishing a leadership position among MCL1 suppressing compounds in clinical development. We are encouraged by observations of deep response and prolonged stable disease with tumor shrinkage in both intravenous schedules tested this far. Importantly, initial clinical data with oral fadraciclib show concordance with intravenous pharmacokinetics. After strengthening our balance sheet, we will now turn our attention to executing a precision medicine strategy to evaluate fadraciclib in patients with solid tumors and achieve our other clinical milestones through late 2022."

    Key Corporate Highlights

    • In light of the pandemic caused by the novel coronavirus and to ensure the health and wellbeing of our employees, patients and the communities we serve, we have redesigned our work flow and business processes in line with current standards and government recommendations. In addition, we are working hard to provide uninterrupted clinical supplies and maintain the integrity of our clinical research. At present, we have not experienced recruitment delays, and our clinical investigators continue to screen and enroll patients. As the future course of the pandemic is uncertain, we will continue to closely monitor developments.
       
    • CYC065-01 Phase 1 part 2 single agent i.v. - We have previously reported that a heavily pretreated patient with MCL1 amplified endometrial cancer achieved a radiographically confirmed partial response (PR) after a month and a half on fadraciclib at 213mg. This patient continues on therapy and reduction in her target tumor lesions is 79% after nine months. An additional patient with cyclin E amplified ovarian cancer achieved stable disease with 29% tumor shrinkage after approximately four months at 213mg. Based on data thus far, we are designing a Phase 1/2 precision medicine study to further evaluate fadraciclib as monotherapy and in combinations in patients with advanced solid tumors.
       
    • CYC065-01 Phase 1 part 3 single agent p.o. - Initial data from an oral capsule formulation of fadraciclib given once daily to three patients with advanced solid tumors demonstrated a predictable pharmacokinetic profile closely overlapping the intravenous form with encouraging exposure levels.
       
    • CYC065-03 Phase 1 fadraciclib i.v. and venetoclax p.o. in AML/MDS - We have dosed 11 heavily pretreated patients with relapsed/refractory (R/R) AML in five dose levels up to 200 mg/m2 of fadraciclib in combination with the venetoclax. Evidence of anticancer activity has been observed in multiple patients with blast reductions in peripheral blood. Preclinical data in AML suggest that targeting both MCL1 and BCL2 may be more beneficial than inhibiting either protein alone.
       
    • CYC065-02 Phase 1 fadraciclib i.v. and venetoclax p.o. in CLL - We have dosed 5 patients with R/R CLL in four dose levels up to 150 mg/m2 of fadraciclib in combination with venetoclax. Evidence of anticancer activity has been observed in two patients who achieved MRD negativity on the combination. Preclinical data suggest that targeting both BCL2 and MCL1 in CLL may be more beneficial than single agent treatment in this setting as well.
       
    • CYC682-11 Phase 1 part 2 sapacitabine p.o. and venetoclax p.o. - We have enrolled 12 patients in two dose cohorts in our DNA Damage Response (DDR) program evaluating an oral combination of sapacitabine and venetoclax in patients with R/R AML/MDS. Sapacitabine is a nucleoside analogue that is active in AML and MDS R/R to prior therapy such as cytarabine or hypomethylating agents. Preclinical data demonstrated synergy of sapacitabine with BCL2 inhibition, which may offer an effective, oral treatment regimen for patients who have failed front-line therapy.
       
    • CYC140-01 Phase 1 CYC140 i.v. - We have enrolled 5 patients in our first-in-human, dose escalation study evaluating CYC140 in patients with advanced leukemias. CYC140 is a small molecule, selective polo-like-kinase 1 (PLK1) inhibitor that has demonstrated potent and selective target inhibition and high activity in xenograft models of human cancers.
       
    • COVID-19 Collaboration - We entered into an agreement with The University of Edinburgh to evaluate the potential of our CDK inhibitors, fadraciclib and seliciclib, for reducing runaway inflammation and subsequent lung injury in patients with COVID-19 disease.

    More information on our clinical trials can be found at www.clinicaltrials.gov.

    Key Business Objectives

    • Report updated fadraciclib Phase 1 safety and efficacy data with frequent i.v. dosing schedule in patients with advanced solid cancers;
    • Report initial safety and PK data from Phase 1 study of fadraciclib oral formulation;
    • Treat first patient in fadraciclib Phase 1/2 precision medicine study;
    • Report initial data from fadraciclib-venetoclax Phase 1 study in R/R AML/MDS & CLL;
    • Report initial data from sapacitabine-venetoclax Phase 1 study in R/R AML/MDS;
    • Report initial data from CYC140 Phase 1 first-in-human study in R/R leukemias; and
    • Report data from Phase 1b/2 sapacitabine-olaparib IST in BRCA mutant metastatic breast cancer when reported by the investigators.

    Financial Highlights

    As of March 31, 2020, cash and cash equivalents totaled $8.9 million, compared to $11.9 million as of December 31, 2019. The decrease of $3.0 million was primarily due to net cash used in operating activities of $2.8 million and $0.1 million of net cash used in financing activities. There were no revenues for each of the three months ended March 31, 2020 and 2019.

    Research and development expenses were $1.1 million for the three months ended March 31, 2020 as compared to $1.0 million for the same period in 2019. Research and development expenses relating to transcriptional regulation increased by almost $0.3 million for the three months ended March 31, 2020 as we continue to progress the clinical evaluation of fadraciclib.

    General and administrative expenses for the three months ended March 31, 2020 were $1.3 million, compared to $1.2 million for the same period of the previous year.

    Total other income, net, for the three months ended March 31, 2020 was $0.9 million, compared to $0.1 million for the same period of the previous year. The increase of $0.8 million for the three months ended March 31, 2020 is primarily related to income received under an Asset Purchase Agreement with Thermo Fisher Scientific Inc.

    United Kingdom research & development tax credits were $0.3 million for each of the three months ended March 31, 2020 and 2019.

    Net loss for the three months ended March 31, 2020 was $1.2 million, compared to $1.8 million for the same period in 2019.

    The Company raised net proceeds of approximately $18.4 million from an equity financing in April 2020.

    The Company estimates that cash resources of $8.9 million as of March 31, 2020 together with the $18.4 million net proceeds from the April 2020 financing will fund currently planned programs through 2022.

    Conference call information:

    US/Canada call: (877) 493-9121 / international call: (973) 582-2750 

    US/Canada archive: (800) 585-8367 / international archive: (404) 537-3406 

    Code for live and archived conference call is 4198767.

    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. 

    About Cyclacel Pharmaceuticals, Inc.

    Cyclacel Pharmaceuticals is a clinical-stage biopharmaceutical company developing innovative cancer medicines based on cell cycle, transcriptional regulation and DNA damage response biology. The transcriptional regulation program is evaluating fadraciclib as a single agent in solid tumors and in combination with venetoclax in patients with relapsed or refractory AML/MDS and CLL. The DNA damage response program is evaluating an oral combination of sapacitabine and venetoclax in patients with relapsed or refractory AML/MDS. An investigator-sponsored trial (IST) is evaluating an oral combination of sapacitabine and olaparib in patients with BRCA mutant breast cancer. The anti-mitotic program is evaluating CYC140, a PLK1 inhibitor, in advanced leukemias/MDS patients. Cyclacel's strategy is to build a diversified biopharmaceutical business focused in hematology and oncology based on a pipeline of novel drug candidates. 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, 
       
    Investor Relations: Russo Partners LLC, Jan Medina, (646) 942-5632,  

    © Copyright 2020 Cyclacel Pharmaceuticals, Inc. All Rights Reserved. The Cyclacel logo and Cyclacel® are trademarks of Cyclacel Pharmaceuticals, Inc.


    CYCLACEL PHARMACEUTICALS, INC.
     CONSOLIDATED STATEMENTS OF
    OPERATIONS (LOSS)
    (In $000s, except share and per share amounts)

                    Three Months Ended
                    December 31,
                      2019       2020  
                         
    Revenues:              
    Total revenues        -       -  
    Operating expenses:        
    Research and development     1,012       1,106  
    General and administrative     1,192       1,318  
    Total operating expenses     2,204       2,424  
    Operating loss         (2,204 )     (2,424 )
    Other income (expense):        
    Foreign exchange gains (losses)     15       69  
    Interest income     79       28  
    Other income, net     -       817  
    Total other income (expense), net     94       914  
    Loss before taxes       (2,110 )     (1,510 )
    Income tax benefit     268       290  
    Net loss             (1,842 )     (1,220 )
    Dividend on convertible exchangeable preferred shares     (50 )     (50 )
    Net loss applicable to common shareholders   $ (1,892 )   $ (1,270 )
    Basic and diluted earnings per common share:        
    Net loss per share – basic and diluted   $ (2.77 )   $ (1.48 )
    Weighted average common shares outstanding     681,910       859,998  


    CYCLACEL PHARMACEUTICALS, INC.
    CONSOLIDATED BALANCE SHEET
    (In $000s, except share, per share, and liquidation preference amounts)

      December 31,   March 31,
     
        2019       2020  
                   
    ASSETS
                 
    Current assets:
                 
    Cash and cash equivalents
    $ 11,885     $ 8,923  
    Prepaid expenses and other current assets
      2,132       2,888  
    Total current assets
      14,017       11,811  
                   
    Property and equipment, net
      27       25  
    Right-of-use lease asset
      1,264       1,151  
    Total assets
    $ 15,308     $ 12,987  
                   
    LIABILITIES AND STOCKHOLDERS' EQUITY
                 
    Current liabilities:
                 
    Accounts payable
    $ 890     $ 250  
    Accrued and other current liabilities
      1,530       1,273  
    Total current liabilities
      2,420       1,523  
    Lease liability
      1,191       1,073  
    Other liabilities
      -       -  
    Total liabilities
      3,611       2,596  
    Stockholders' equity
      11,697       10,391  
    Total liabilities and stockholders' equity
    $ 15,308     $ 12,987  


    SOURCE: Cyclacel Pharmaceuticals, Inc.

     

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  5. BERKELEY HEIGHTS, N.J., May 05, 2020 (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 first quarter 2020 financial results on Tuesday, May 12, 2020. 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: 

    US/Canada call: (877) 493-9121 / international call: (973) 582-2750 

    US/Canada archive: (800) 585-8367 / international archive: (404) 537-3406 

    Code for live and archived conference call is 4198767.

    For the live and archived webcast, please visit the Corporate Presentations page on the Cyclacel…

    BERKELEY HEIGHTS, N.J., May 05, 2020 (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 first quarter 2020 financial results on Tuesday, May 12, 2020. 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: 

    US/Canada call: (877) 493-9121 / international call: (973) 582-2750 

    US/Canada archive: (800) 585-8367 / international archive: (404) 537-3406 

    Code for live and archived conference call is 4198767.

    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. 

    About Cyclacel Pharmaceuticals, Inc.

    Cyclacel Pharmaceuticals is a clinical-stage biopharmaceutical company developing innovative cancer medicines based on cell cycle, transcriptional regulation and DNA damage response biology. The transcriptional regulation program is evaluating fadraciclib as a single agent in solid tumors and in combination with venetoclax in patients with relapsed or refractory AML/MDS and CLL. The DNA damage response program is evaluating an oral combination of sapacitabine and venetoclax in patients with relapsed or refractory AML/MDS. An IST is evaluating an oral combination of sapacitabine and olaparib in patients with BRCA mutant breast cancer. The anti-mitotic program is evaluating CYC140, a PLK1 inhibitor, in advanced leukemias/MDS patients. Cyclacel's strategy is to build a diversified biopharmaceutical business focused in hematology and oncology based on a pipeline of novel drug candidates. 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 for Cyclacel Pharmaceuticals, Inc.

    Company: Paul McBarron, (908) 517-7330,
    Investor Relations: Russo Partners LLC, Jan Medina, (646) 942-5632, 

    © Copyright 2020 Cyclacel Pharmaceuticals, Inc. All Rights Reserved. The Cyclacel logo and Cyclacel® are trademarks of Cyclacel Pharmaceuticals, Inc.

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