Investors & Media
Cyclacel Pharmaceuticals Reports Fourth Quarter and Full Year 2018 Financial Results
– Conference Call Scheduled
"We are executing on our targeted oncology strategy with the objective of delivering data readouts from multiple clinical programs,” said
Fourth Quarter and Full-Year Highlights
CYC065 CDK Inhibitor
Initiated a Phase 1 clinical trial evaluating CYC065, a CDK2/9 inhibitor, in combination with venetoclax in patients with relapsed/refractory CLL. The first patient has been treated with this dose regimen without dose-limiting toxicity. The strong biological rationale of dual Mcl-1 and Bcl-2 suppression was presented at the 2018 AACR in a poster titled “Strategic combination of the cyclin-dependent kinase inhibitor CYC065 with venetoclax to target anti-apoptotic proteins in chronic lymphocytic leukemia.” The data showed an enhanced effect of the combination of CYC065 and venetoclax in CLL tumor samples, including demonstrating activity in 17p deleted samples which were resistant to either agent alone.
Data from the Phase 1 part 1 clinical study of CYC065 monotherapy administered intravenously over 4 hours every 3 weeks in patients with advanced solid tumors were reported at an oral presentation at the 2018 AACR. Prolonged reduction of Mcl-1 expression was observed in 11 out of 13 patients treated at the recommended Phase 2 dose (RP2D) following a single dose of CYC065. Cyclacel continues to enroll patients in part 2 of the study evaluating CYC065 in a more intensive schedule for 2 days per week over 2 weeks of a three-week cycle. Part 3 of the study is planned to evaluate an oral CYC065 formulation.
Discussions with principal investigators and/or cooperative groups progressed with the objective of evaluating CYC065 in patients with certain hematological malignancies and solid tumors.
DNA Damage Response (DDR) Program
The first two patients have been dosed in the Phase 1b/2 investigator-sponsored study of sapacitabine in combination with olaparib, an approved PARP inhibitor, in patients with BRCA mutant breast cancer. According to the investigators both patients achieved tumor shrinkage. Dual targeting of the DNA damage response pathway with the addition of sapacitabine to olaparib may enhance the efficacy of the current standard of care for such patients.
Patient enrolment has continued in part 3 of a Phase 1 study evaluating a revised dosing schedule of sequential sapacitabine and seliciclib, Cyclacel’s first-generation CDK inhibitor, in BRCA mutation positive patients with advanced breast, ovarian and pancreatic cancer. New data on an expanded cohort from part 1 of this study will be the subject of a poster titled “Expansion cohort of Phase I study of oral sapacitabine and oral seliciclib in patients with metastatic breast cancer and BRCA1/2 mutations” at the 2019 AACR.
CYC140 PLK1 Inhibitor
The first patient has been dosed in a Phase 1 first-in-human 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.
SEAMLESS Phase 3 Study
Stratified and exploratory subgroup analyses have defined a subgroup of patients for whom the sapacitabine regimen may represent an improvement over low intensity treatment by decitabine alone. Following consultation with three European regulatory authorities regarding a potential approval pathway for sapacitabine the Company intends to submit a request for scientific advice to the
Entered into a collaboration with
Entered into a Common Stock Sales Agreement with
2019 Key Upcoming Business Objectives
- Report expansion cohort, Phase 1 clinical data with an oral sequential regimen of sapacitabine and seliciclib in patients with BRCA mutant metastatic breast cancer at the 2019 AACR
- Initiate CYC065-venetoclax Phase 1 study in patients with relapsed or refractory AML or MDS
- Initiate sapacitabine-venetoclax Phase 1 study in patients with relapsed or refractory AML or MDS
- Report initial data from the CYC065-venetoclax Phase 1 studies in leukemias
- Report initial data from the CYC140 Phase 1 First-in-Human study
- Report initial data and bioavailability from the Phase 1 study of an oral formulation of CYC065
- Report updated CYC065 Phase 1 data in patients with advanced solid cancers
- Report data from the IST Phase 1b/2 trial of sapacitabine-olaparib combination in patients with BRCA mutant metastatic breast cancer when reported by the investigators
- Determine regulatory pathway and submissibility of sapacitabine in elderly AML
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
Conference call information:
Code for live and archived conference call is 9719419.
For the live and archived webcast, please visit the Corporate Presentations page on the Cyclacel website at www.cyclacel.com. The webcast will be archived for 90 days and the audio replay for 7 days.
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, Cyclacel may not obtain approval to market its product candidates, the risks associated with reliance on outside financing to meet capital requirements, and the risks associated with reliance on collaborative partners for further clinical trials, development and commercialization of product candidates. You are urged to consider statements that include the words "may," "will," "would," "could," "should," "believes," "estimates," "projects," "potential," "expects," "plans," "anticipates," "intends," "continues," "forecast," "designed," "goal," or the negative of those words or other comparable words to be uncertain and forward-looking. For a further list and description of the risks and uncertainties the Company faces, please refer to our most recent Annual Report on Form 10-K and other periodic and other filings we file with the
|Company:||Paul McBarron, (908) 517-7330, firstname.lastname@example.org|
|Investor Relations:||Russo Partners LLC, Alexander Fudukidis, (646) 942-5632, email@example.com|
© Copyright 2019 Cyclacel Pharmaceuticals, Inc. All Rights Reserved. The Cyclacel logo and Cyclacel® are trademarks of Cyclacel Pharmaceuticals, Inc.
CYCLACEL PHARMACEUTICALS, INC.
CONSOLIDATED STATEMENTS OF OPERATIONS (LOSS)
(In $000s, except share and per share amounts)
|Twelve Months Ended
|Collaboration and research and development revenue||-||150|
|Research and development||4,237||4,327|
|General and administrative||5,254||5,371|
|Total operating expenses||9,491||9,698|
|Other income (expense):|
|Change in valuation of financial instruments associated with stock purchase agreement||-||-|
|Foreign exchange gains (losses)||(39||)||(90||)|
|Other income, net||949||682|
|Total other income (expense), net||1,028||923|
|Loss from continuing operations before taxes||(8,463||)||(8,625||)|
|Income tax benefit||993||1,342|
|Net loss from continuing operations||(7,470||)||(7,288||)|
|Dividend on convertible exchangeable preferred shares||(201||)||(201||)|
|Beneficial conversion feature of Series A convertible stock||(3,638||)||-|
|Conversion of Series A convertible preferred stock||(3,537||)||-|
|Net loss applicable to common shareholders||$||(14,846||)||$||(7,489||)|
|Basic and diluted earnings per common share:|
|Net loss per share – basic and diluted||$||(1.95||)||$||(0.62||)|
|Weighted average common shares outstanding||7,631,152||12,094,131|
CYCLACEL PHARMACEUTICALS, INC.
CONSOLIDATED BALANCE SHEET
(In $000s, except share, per share, and liquidation preference amounts)
|December 31,||December 31,|
|Cash and cash equivalents||$||23,910||$||17,504|
|Prepaid expenses and other current assets||2,064||2,283|
|Total current assets||25,974||19,787|
|Property and equipment, net||29||36|
|LIABILITIES AND STOCKHOLDERS’ EQUITY|
|Accrued and other current liabilities||2,555||1,732|
|Total current liabilities||4,113||4,451|
|Total liabilities and stockholders’ equity||$||26,003||$||19,823|
SOURCE: Cyclacel Pharmaceuticals, Inc.