Investors
News Release
Cyclacel Pharmaceuticals Reports Third Quarter 2020 Financial Results
Nov 11 2020
The Company's net loss applicable to common shareholders for the three months ended
“We continue to execute on our clinical development plan for fadraciclib and CYC140 in both liquid and solid cancers,” said
Key Corporate 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. He has management experience in academic research, clinical practice and pharmaceutical industry settings. As CMO, he is responsible for advancing Cyclacel’s pipeline and is leading clinical strategy, patient safety and medical affairs. - Fadraciclib Oral Presentation at the Plenary Session of the 32nd EORTC-NCI-AACR (ENA) Symposium 2020
• In part 2 of a Phase 1, dose escalation study, fadraciclib was administered intravenously as monotherapy to 24 heavily pretreated patients with various advanced solid tumors.
• Out of 11 patients treated at the fourth dose level one achieved confirmed partial response (PR) and two stable disease (SD).
• The PR was observed after a month and a half on fadraciclib in a patient with MCL1-amplified endometrial cancer who had failed seven lines of prior therapy. The patient remains on treatment after 16 months with 92% reduction in target tumor lesions.
• SD was observed in a patient with cyclin E amplified ovarian cancer who achieved 29% shrinkage in target tumor lesions after four months and a patient with fallopian tube adenocarcinoma with undetermined protein level.
• In three patients treated in part 3 with oral fadraciclib high oral bioavailability and overlapping pharmacokinetics were observed compared to the intravenously administered, identical schedule in part 2.
- CYC065-02 Phase 1 fadraciclib i.v. and venetoclax p.o. in CLL - five patients with R/R CLL have been treated in four dose levels up to 150 mg/m2 of fadraciclib in combination with venetoclax. Fadraciclib is administered after completion of venetoclax ramp. Antileukemic activity was observed in three patients who achieved MRD negativity on the combination, one in bone marrow and two in bone marrow and peripheral blood. The latter two patients have also demonstrated continued shrinkage of lymph nodes on the combination. In one patient all target lesions and in the other 2 out of 4 lesions have shrunk below 1.5 cm. Both are waiting for confirmation of response. Preclinical data support a dual targeting strategy of both BCL2 and MCL1 in CLL.
- CYC065-03 Phase 1 fadraciclib i.v. and venetoclax p.o. in AML/MDS - fourteen heavily pretreated patients with relapsed/refractory (R/R) AML were treated in five dose levels up to 200 mg/m2 of fadraciclib in combination with venetoclax. Antileukemic activity has been observed in four out of twelve patients available for assessment. Preclinical data in AML suggest that targeting both MCL1 and BCL2 may be more beneficial than inhibiting either protein alone.
- CYC140-01 Phase 1 CYC140 i.v. - We have enrolled 7 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 parallel with hematological malignancies, we are planning studies of CYC140 in solid tumors.
- CYC682-11 Phase 1 part 2 sapacitabine p.o. and venetoclax p.o. - twelve patients have been enrolled 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 a BCL2 inhibitor, which may offer an effective, oral treatment regimen for patients who have failed front-line therapy.
- Appointed
Karin L. Walker to the Board of Directors.Ms. Walker brings over 30 years of extensive finance experience in biopharmaceuticals, including in public biotechnology companies, and technology companies.Ms. Walker currently serves as the Chief Accounting Officer of Prothena Corporation plc, a late-stage clinical company with expertise in protein dysregulation and a pipeline of novel investigational therapeutics focused on neurodegenerative and rare peripheral amyloid diseases, and has held this position since 2013.
More information on our clinical trials can be found here.
Key Business Objectives
- Treat first patient with orally-administered fadraciclib in Phase 1/2 advanced solid tumors study;
- Report initial data from fadraciclib-venetoclax Phase 1 study in R/R AML/MDS & CLL;
- Report safety and PK data from Phase 1 study of fadraciclib oral formulation;
- Report initial data from CYC140 Phase 1 first-in-human study in R/R leukemias; and
- Report initial data from sapacitabine-venetoclax Phase 1 study in R/R AML/MDS;
Financial Highlights
As of
Research and development expenses were
General and administrative expenses for the three months ended
Total other income, net, for the three months ended
Net loss for the three months ended
The Company estimates that cash resources of
Conference call information:
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Code for live and archived conference call is 4884678.
For the live and archived webcast, please visit the Corporate Presentations page on the
About
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
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© 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 | |||||||||||
| 2019 | 2020 | ||||||||||
| Revenues: | |||||||||||
| Total revenues | - | - | |||||||||
| Operating expenses: | |||||||||||
| Research and development | 1,063 | 1,075 | |||||||||
| General and administrative | 1,285 | 1,497 | |||||||||
| Total operating expenses | 2,348 | 2,572 | |||||||||
| Operating loss | (2,348 | ) | (2,572 | ) | |||||||
| Other income (expense): | |||||||||||
| Foreign exchange gains (losses) | 79 | (25 | ) | ||||||||
| Interest income | 42 | 4 | |||||||||
| Other income, net | 53 | 56 | |||||||||
| Total other income (expense), net | 174 | 35 | |||||||||
| Loss before taxes | (2,174 | ) | (2,537 | ) | |||||||
| Income tax benefit | 273 | 281 | |||||||||
| Net loss | (1,901 | ) | (2,256 | ) | |||||||
| Dividend on convertible exchangeable preferred shares | (50 | ) | (50 | ) | |||||||
| Net loss applicable to common shareholders | $ | (1,951 | ) | $ | (2,306 | ) | |||||
| Basic and diluted earnings per common share: | |||||||||||
| Net loss per share – basic and diluted | $ | (2.27 | ) | $ | (0.47 | ) | |||||
| Weighted average common shares outstanding | 859,998 | 4,863,984 | |||||||||
CONSOLIDATED BALANCE SHEET
(In $000s, except share, per share, and liquidation preference amounts)
| 2019 | 2020 | |||||||
| ASSETS | ||||||||
| Current assets: | ||||||||
| Cash and cash equivalents | $ | 11,885 | $ | 23,130 | ||||
| Prepaid expenses and other current assets | 2,132 | 2,804 | ||||||
| Total current assets | 14,017 | 25,934 | ||||||
| Property and equipment, net | 27 | 64 | ||||||
| Right-of-use lease asset | 1,264 | 1,215 | ||||||
| Total assets | $ | 15,308 | $ | 27,213 | ||||
| LIABILITIES AND STOCKHOLDERS’ EQUITY | ||||||||
| Current liabilities: | ||||||||
| Accounts payable | $ | 890 | $ | 455 | ||||
| Accrued and other current liabilities | 1,530 | 1,257 | ||||||
| Total current liabilities | 2,420 | 1,712 | ||||||
| Lease liability | 1,191 | 1,063 | ||||||
| Total liabilities | 3,611 | 2,775 | ||||||
| Stockholders’ equity | 11,697 | 24,438 | ||||||
| Total liabilities and stockholders’ equity | $ | 15,308 | $ | 27,213 | ||||
SOURCE:
Source: Cyclacel