Investors & Media
Cyclacel Pharmaceuticals Reports Fourth Quarter and Full Year 2019 Financial Results
– Anticancer Activity of Fadraciclib (CYC065) Monotherapy in Patients with MCL1 Amplified Solid Tumor and Fadraciclib-venetoclax Combination in Patients with Relapsed or Refractory AML/MDS and CLL –
– Conference Call Scheduled
“Our fadraciclib (CYC065) CDK inhibitor is establishing a leadership position among MCL1 suppressing compounds in clinical development,” said
Key Corporate Highlights
- CYC065-01 Phase 1 part 2 single agent i.v. – In
November 2019, we reported anticancer activity in a heavily pretreated a patient with MCL1 amplified endometrial cancer who achieved a radiographically confirmed partial response (PR) after 4 cycles at 213mg. The patient remains on study after 10 cycles and shrinkage of her target tumor lesions has reached 73%. An additional patient with cyclin E amplified ovarian cancer achieved stable disease after 4 cycles at 213mg with 29% tumor shrinkage. We are expanding the 213mg dose level to recruit additional patients and determine the recommended Phase 2 dose.
- CYC065-01 Phase 1 part 3 single agent p.o. – We are evaluating an oral capsule form of fadraciclib in patients with advanced solid tumors and have enrolled two patients at 75mg and 150mg once daily. Pharmacokinetic (PK) data in the two patients demonstrated a predictable PK profile closely overlapping the i.v. form with encouraging exposure levels.
- CYC065-03 Phase 1 fadraciclib i.v. and venetoclax p.o. – We have dosed 11 heavily pretreated patients with R/R AML in five dose levels up to 200 mg/m2 in combination with the BCL2 inhibitor venetoclax. Evidence of anticancer activity has been observed in multiple patients with blast reductions in peripheral blood. Preclinical AML data demonstrated synergy of fadraciclib and venetoclax, suggesting that targeting both BCL2 and MCL1 may be more beneficial than inhibiting either protein alone.
- CYC065-02 Phase 1 fadraciclib i.v. and venetoclax p.o. – We have dosed 3 patients with R/R CLL in two dose levels up to 85 mg/m2 in combination with venetoclax. Evidence of anticancer activity has been observed in two patients who experienced reduction in lymph node size with one of them achieving MRD negative status. Preclinical CLL data demonstrated synergy of fadraciclib and venetoclax, suggesting that targeting both BCL2 and MCL1 may be more beneficial than inhibiting either protein alone.
- CYC682-11 Phase 1b/2 part 2 sapacitabine p.o. and venetoclax p.o.– We have enrolled 10 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 4 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.
More information on our clinical trials can be found at www.clinicaltrials.gov.
Key Business Objectives for 2020
- Report updated Phase 1 safety, PK and efficacy data for fadraciclib utilizing a frequent i.v. dosing schedule in patients with advanced solid cancers;
- Report initial safety and PK data from the Phase 1 study of an oral formulation of fadraciclib;
- Report initial safety and proof of concept data from the fadraciclib-venetoclax Phase 1 studies in R/R AML/MDS and CLL;
- Report initial data from the sapacitabine-venetoclax Phase 1b/2 study in patients with R/R AML/MDS;
- Report initial data from the CYC140 Phase 1 first-in-human study in R/R leukemias; and
- Report data from the Phase 1b/2 IST of sapacitabine-olaparib combination in patients with BRCA mutant metastatic breast cancer when reported by the investigators.
Revenues for the three months and year ended
Research and development expenses were
General and administrative expenses for the three months and year ended
Total other income, net for the three months and year ended
Net loss for the three months and year ended
The Company raised net proceeds of approximately
The Company estimates that cash resources of
Conference call information:
Code for live and archived conference call is 6761906.
For the live and archived webcast, please visit the Corporate Presentations page on the
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
© Copyright 2020 Cyclacel Pharmaceuticals, Inc. All Rights Reserved. The
CONSOLIDATED STATEMENTS OF OPERATIONS (LOSS)
(In $000s, except share and per share amounts)
|Three Months Ended|
|Research and development||1,142||1,430|
|General and administrative||1,474||1,363|
|Total operating expenses||2,616||2,793|
|Other income (expense):|
|Foreign exchange gains (losses)||(48||)||(14||)|
|Other income, net||50||8|
|Total other income (expense), net||95||41|
|Loss before taxes||(2,371||)||(2,752||)|
|Income tax benefit||353||449|
|Dividend on convertible exchangeable preferred shares||(50||)||(51||)|
|Net loss applicable to common shareholders||$||(2,068||)||$||(2,354||)|
|Basic and diluted earnings per common share:|
|Net loss per share – basic and diluted||$||(0.17||)||$||(0.14||)|
|Weighted average common shares outstanding||12,381,031||17,199,974|
CONSOLIDATED BALANCE SHEET
(In $000s, except share, per share, and liquidation preference amounts)
|Cash and cash equivalents||$||17,504||$||11,885|
|Prepaid expenses and other current assets||2,283||2,132|
|Total current assets||19,787||14,017|
|Property and equipment, net||36||27|
|Right-of-use lease asset||-||1,264|
|LIABILITIES AND STOCKHOLDERS’ EQUITY|
|Accrued and other current liabilities||1,732||1,530|
|Total current liabilities||4,451||2,420|
|Total liabilities and stockholders’ equity||$||19,823||$||15,308|