Investors & Media
Cyclacel Pharmaceuticals Reports Second Quarter 2018 Financial Results
The Company's net loss applicable to common shareholders for the three months ended
“Phase 1 data presented for CYC065, our lead CDK inhibitor, at the recent
Key Company Highlights
- Patient enrollment continues for part 2 of the CYC065 monotherapy Phase 1 study in patients with advanced solid tumors. Part 2 is evaluating an increased dosing frequency of 2 days per week for 2 weeks of a three-week cycle. Part 2 will also look to evaluate the efficacy of CYC065 in Mcl-1, MYC or cyclin E amplified cancers through the monitoring of select biomarkers relevant to CYC065’s mechanism of action.
- Cyclacel continues to prepare for initiation of a Phase 1 clinical trial evaluating CYC065 in combination with venetoclax, a Bcl-2 inhibitor, in patients with relapsed/refractory CLL. A poster presented at the 2018 AACR highlighted preclinical data supporting the enhanced effect of combination therapy with CYC065 and venetoclax in CLL tumor samples, including those with 17p deletions. A CYC065-venetoclax combination regimen was active in two CLL samples resistant to either agent alone supporting the hypothesis that dual targeting of Mcl-1 and Bcl-2 dependent mechanisms could induce synergistic cell death.
- Patient enrollment continues for part 3 of the Phase 1 combination study evaluating sapacitabine and seliciclib (Cyclacel’s first-generation CDK inhibitor) in patients with advanced cancer, including BRCA positive breast, ovarian and pancreatic cancer patients. The objective of part 3 of the study is to test a revised dosing schedule to evaluate safety and initial efficacy.
- Cyclacel has submitted briefing documents and scheduled meetings with certain European regulatory authorities with the objective of determining a potential regulatory pathway for sapacitabine in elderly AML. The Company believes that the subgroup findings from the Phase 3 SEAMLESS study have defined a patient population for whom the sapacitabine regimen may represent an improvement over low intensity treatment by decitabine alone.
The U.S. Food and Drug Administration( FDA) has cleared the Investigational New Drug (IND) application for CYC140, the Company’s internally-discovered, novel inhibitor of Polo-like-kinase 1, or PLK1. A first-in-human Phase 1 study is being planned.
Key Upcoming Business Objectives
- Initiate Phase 1b clinical trial evaluating CYC065 in combination with venetoclax in patients with relapsed or refractory CLL;
- Start enrollment in a Phase 1b/2 IST of sapacitabine and an approved PARP inhibitor combination treatment in patients with BRCA mutant breast cancer;
- Initiate CYC065 Phase 1b in advanced leukemias;
- Provide a clinical update from part 2 of the Phase 1 study evaluating CYC065 monotherapy in patients with advanced cancers;
- Conduct EU regulatory authority meetings regarding the SEAMLESS study of sapacitabine in elderly AML;
- Initiate Phase 1 trial evaluating CYC140, a PLK1 inhibitor; and
- Provide clinical update and complete enrollment of part 3 of the Phase 1 study of the sapacitabine and seliciclib combination in BRCA positive, breast, ovarian and pancreatic cancer patients.
Research and development expenses were
General and administrative expenses were
Other income, net for the three months ended
Net loss for the three months ended
Conference call information:
Code for live and archived conference call is 4689089
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
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© Copyright 2018 Cyclacel Pharmaceuticals, Inc. All Rights Reserved. The Cyclacel logo and Cyclacel® are trademarks of Cyclacel Pharmaceuticals, Inc.
CYCLACEL PHARMACEUTICALS, INC.
CONSOLIDATED STATEMENTS OF OPERATIONS
(In $000s, except share and per share amounts)
|Three Months Ended
|Six months Ended
|Research and development||1,222||1,182||2,534||1,980|
|General and administrative||1,267||1,283||2,648||2,647|
|Total operating expenses||2,489||2,465||5,182||4,627|
|Other income (expense):|
|Foreign exchange gains (losses)||16||(39||)||(43||)||(43||)|
|Other income, net||-||66||879||632|
|Total other income (expense)||34||111||866||742|
|Loss before taxes||(2,455||)||(2,354||)||(4,316||)||(3,885||)|
|Income tax benefit||268||502||574||684|
|Dividend on convertible exchangeable preferred shares||(50||)||(50||)||(100||)||(101||)|
|Net loss applicable to common shareholders||$||(2,237||)||$||(1,902||)||$||(3,842||)||$||(3,302||)|
|Basic and diluted earnings per common share:|
|Net loss per share – basic and diluted||$||(0.50||)||$||(0.16||)||$||(0.88||)||$||(0.28||)|
|Weighted average common shares outstanding||4,434,441||11,997,447||4,353,333||11,997,447|
CYCLACEL PHARMACEUTICALS, INC.
CONSOLIDATED BALANCE SHEET
(In $000s, except share, per share, and liquidation preference amounts)
|December 31, 2017||June 30, 2018|
|Cash and cash equivalents||$||23,910||$||19,824|
|Prepaid expenses and other current assets||2,064||2,863|
|Total current assets||25,974||22,687|
|Property, plant and equipment (net)||29||43|
|LIABILITIES AND STOCKHOLDERS’ EQUITY|
|Accrued and other current liabilities||2,555||2,319|
|Total current liabilities||4,113||3,994|
|Total liabilities and stockholders’ equity||$||26,003||$||22,730|
SOURCE: Cyclacel Pharmaceuticals, Inc.