Cyclacel Pharmaceuticals Reports Second Quarter 2020 Financial Results

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.a??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,a?? said Spiro Rombotis, President and Chief Executive Officer. a??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.a??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. a?? 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.inAML/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 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.
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