Investors & Media
Cyclacel Pharmaceuticals Reports First Quarter 2020 Financial Results
- Conference Call Scheduled
- Following Recent Financing Cash Runway to 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
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 Edinburghto 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.
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 raised net proceeds of approximately
The Company estimates that cash resources of
Conference call information:
Code for live and archived conference call is 4198767.
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 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,
© Copyright 2020 Cyclacel Pharmaceuticals, Inc. All Rights Reserved. The
CONSOLIDATED STATEMENTS OF OPERATIONS (LOSS)
(In $000s, except share and per share amounts)
|Three Months Ended|
|Research and development||1,012||1,106|
|General and administrative||1,192||1,318|
|Total operating expenses||2,204||2,424|
|Other income (expense):|
|Foreign exchange gains (losses)||15||69|
|Other income, net||-||817|
|Total other income (expense), net||94||914|
|Loss before taxes||(2,110||)||(1,510||)|
|Income tax benefit||268||290|
|Dividend on convertible exchangeable preferred shares||(50||)||(50||)|
|Net loss applicable to common shareholders||$||(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|
CONSOLIDATED BALANCE SHEET
(In $000s, except share, per share, and liquidation preference amounts)
|Cash and cash equivalents
|Prepaid expenses and other current assets
|Total current assets
|Property and equipment, net
|Right-of-use lease asset
|LIABILITIES AND STOCKHOLDERS’ EQUITY
|Accrued and other current liabilities
|Total current liabilities
|Total liabilities and stockholders’ equity