Investors & Media
Cyclacel Pharmaceuticals Reports Fourth Quarter and Full Year 2020 Financial Results
The Company's net loss applicable to common shareholders for the three months and year ended
“During 2020 we have reported on fadraciclib’s oral bioavailability and evidence of durable anticancer activity,” said
Key 2020 Highlights
- Appointed Mark Kirschbaum, M.D. as Senior Vice President and Chief Medical Officer. Dr. Kirschbaum is a highly experienced hematologist/oncologist with over 30 years of experience in molecular medicine, new drug development, clinical trial design and patient care. Most recently, Dr. Kirschbaum served as Vice President, Hematology/Oncology at ArQule Inc.
- Appointed two new Directors to strengthen and broaden our Board’s skill base:
Brian Schwartz, M.D. has wide-ranging experience as a drug development expert in the biopharmaceutical industry primarily in oncology, hematology, and rare diseases. Brian was formerly Senior Vice President, Head of Research & Development and Chief Medical Officer of ArQule Inc., which was acquired by Merck & Co. in 2020 for $2.7 billion. Dr. Schwartzis a member of the Company’s Science & Technology Committee. Karin L. Walkerbrings over 30 years of extensive finance experience in biopharmaceuticals, including public biotechnology and technology companies. Ms. Walkercurrently serves as the Chief Accounting Officer of Prothena Corporation plc. Ms. Walkerhas been appointed as Chair of the Audit Committee.
- Raised approximately $25 million in net cash in two equity financings, including a strategic investment by Acorn Bioventures of
$6.9 million, net. An additional $8.8 millionof proceeds have been received through warrant exercises ( $4.3 millionof which after year end).
- Reported data from a Phase 1 study of fadraciclib as a single agent at the Plenary Session of the 32nd EORTC-NCI-AACR (ENA) Symposium:
- Radiographically confirmed partial response (PR) after a month and a half on i.v. fadraciclib in a patient with MCL1-amplified endometrial cancer, who failed seven lines of prior therapy and is continuing treatment for more than 18 months with 96% reduction in target tumor lesions.
- High bioequivalence observed in five patients treated with oral fadraciclib.
- Enrolled 19 patients with relapsed or refractory AML/MDS and CLL receiving i.v. fadraciclib in combination with venetoclax with evidence of antileukemic activity.
- Enrolled seven patients evaluating i.v. CYC140 in patients with advanced leukemias.
- Enrolled 12 patients with relapsed or refractory AML/MDS in a Phase 1/2 study evaluating an oral regimen of sapacitabine in combination with venetoclax.
- Announced a peer-reviewed publication describing the discovery of fadraciclib in PLOS ONE. Authored by scientists from Cyclacel and The Institute of Cancer Research, London, the publication shows that targeting of CDK2 and CDK9 holds broad therapeutic potential.
More information on our clinical trials can be found here.
Key Business Objectives for 2021
- First patient dosed with oral fadraciclib in Phase 1b/2 advanced solid tumor and leukemia studies
- First patient dosed with oral CYC140 in Phase 1/2 advanced solid tumor and leukemia studies
- Manufacture clinical supplies of oral fadraciclib and oral CYC140 for registration-enabling studies
- Data on safety and antileukemic activity from the i.v. fadraciclib-venetoclax Phase 1 study in relapsed/refractory AML and CLL
- Data from the sapacitabine-venetoclax Phase 1/2 study in relapsed/refractory AML or MDS
- Initial data from the i.v. CYC140 Phase 1 First-in-Human study in patients with advanced leukemias
- Data from the Phase 1b/2 IST of sapacitabine-olaparib combination in patients with BRCA mutant metastatic breast cancer when reported by the investigators.
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 proforma cash resources, including proceeds of recent warrant exercises after
Conference call information:
Code for live and archived conference call is 7389616. Webcast link
For the live and archived webcast, please visit the Corporate Presentations page on the
Cyclacel Pharmaceuticals 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, in solid tumors and hematological malignancies. The anti-mitotic program is evaluating CYC140, a PLK1 inhibitor, in advanced cancers. 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.
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 2021 Cyclacel Pharmaceuticals, Inc. All Rights Reserved. The
CONSOLIDATED STATEMENTS OF OPERATIONS (LOSS)
(In $000s, except share and per share amounts)
|Three Months Ended|
|Research and development||1,430||1,415|
|General and administrative||1,363||1,753|
|Total operating expenses||2,793||3,168|
|Other income (expense):|
|Foreign exchange gains (losses)||(14||)||(20||)|
|Other income, net||8||-|
|Total other income (expense), net||41||(14||)|
|Loss before taxes||(2,752||)||(3,182||)|
|Income tax benefit||449||378|
|Dividend on convertible exchangeable preferred shares||(51||)||(51||)|
|Beneficial conversion feature of Series B preferred stock||-||(3,775||)|
|Net loss applicable to common shareholders||$||(2,354||)||$||(6,630||)|
|Basic and diluted earnings per common share:|
|Net loss per share – basic and diluted||$||(2.74||)||$||(1.34||)|
|Weighted average common shares outstanding||858,189||4,931,543|
CONSOLIDATED BALANCE SHEET
(In $000s, except share, per share, and liquidation preference amounts)
|Cash and cash equivalents||$||11,885||$||33,406|
|Prepaid expenses and other current assets||2,132||2,063|
|Total current assets||14,017||35,469|
|Property and equipment, net||27||106|
|Right-of-use lease asset||1,264||1,227|
|LIABILITIES AND STOCKHOLDERS’ EQUITY|
|Accrued and other current liabilities||1,530||1,972|
|Total current liabilities||2,420||2,486|
|Total liabilities and stockholders’ equity||$||15,308||$||36,802|