Investors
News Release
Cyclacel Pharmaceuticals Reports First Quarter 2018 Financial Results
May 14 2018
The Company's net loss applicable to common shareholders for the three months ended
“Two presentations at the recent
Key Highlights
- CYC065, CDK2/9 inhibitor, Phase 1 data at oral presentation at the 2018
American Association for Cancer Research (AACR) Annual Meeting. In part 1 of this ongoing, first-in-human, single agent, dose escalation study, prolonged reduction of Mcl-1 expression was observed in 11 out of 13 patients treated at the recommended Phase 2 dose, or RP2D, following a single dose of CYC065, which was generally well tolerated. Preliminary anticancer activity was observed in 6 patients, of which 5 were treated at the RP2D; genetic data was available for 3 out of 6 patients and all 3 were reported by investigators to have molecular features of their cancers associated with CYC065’s mechanism of action, including amplification of Mcl-1, MYC or cyclin E.
- Following completion of part 1, Cyclacel has initiated part 2 of the study evaluating CYC065 in a more frequent dosing schedule of 2 days per week for 2 weeks of a three-week cycle. Part 2 will enroll patients with advanced cancers and evaluate efficacy in Mcl-1, MYC or cyclin E amplified cancers. Several biomarkers relevant to CYC065’s mechanism of action will be assessed.
- A poster was presented at the 2018 AACR meeting titled “Strategic combination of the cyclin-dependent kinase inhibitor CYC065 with venetoclax to target anti-apoptotic proteins in chronic lymphocytic leukemia”. The preclinical study led by
William Plunkett , PhD, Professor and Deputy Chair,Department of Experimental Therapeutics ,The University of Texas MD Anderson Cancer Center , highlighted data that showed the efficacy of CYC065 therapy in combination with the Bcl-2 inhibitor, venetoclax (AbbVie ), in CLL samples, including those with 17p deletions. The CYC065-venetoclax combination was also active in two CLL samples which were resistant to either agent alone. These findings support the hypothesis that dual targeting of the Mcl-1- and Bcl-2-dependent mechanisms could induce synergistic cell death.
- The Company plans to initiate a clinical study in patients with relapsed/refractory CLL in combination with venetoclax, in whom durable suppression of Mcl-1 may be beneficial.
- Part 3 of the Phase 1 combination study of sapacitabine and seliciclib (Cyclacel’s first generation CDK inhibitor) continues enrolment with the objective of testing a revised dosing schedule in patients with advanced cancer, including BRCA positive breast, ovarian and pancreatic cancer patients.
- The Company has completed statistical and exploratory analyses of the SEAMLESS Phase 3 study results and is preparing briefing documents for submission to regulatory authorities with the objective of determining a potential regulatory pathway for sapacitabine in AML. The Company believes that the subgroup results have defined a patient population for whom the sapacitabine regimen may represent an improvement over low intensity treatment by decitabine alone.
2018 Key Upcoming Business Objectives
- Report updated CYC065 Phase 1 data in patients with advanced cancers;
- Initiate CYC065 Phase 1b in relapsed/refractory CLL in combination with venetoclax;
- Start enrollment in a Phase 1b/2 IST of CYC065 in pediatric patients with neuroblastoma;
- Start enrollment in a Phase 1b/2 IST of a combination regimen of an approved PARP inhibitor and sapacitabine in patients with BRCA mutant breast cancer;
- Conduct regulatory authority meetings regarding the SEAMLESS study of sapacitabine in AML;
- Update mature data from the part 1 extension of the sapacitabine and seliciclib combination in BRCA positive advanced breast cancer patients and complete part 3 enrollment of the sapacitabine and seliciclib combination in BRCA positive, breast, ovarian and pancreatic cancer patients;
- IND review for CYC140 PLK1 inhibitor.
Financial Highlights
As of
Research and development expenses were
General and administrative expenses were
Other income, net for the three months ended
The
Net loss for the three months ended
Conference call information:
US/
US/
Code for live and archived conference call is 6069578
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.
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 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
| Contacts | |
| Company: | Paul McBarron, (908) 517-7330, pmcbarron@cyclacel.com |
| Investor Relations: | Russo Partners LLC, Alexander Fudukidis, (646) 942-5632, alex.fudukidis@russopartnersllc.com |
© 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 March 31, |
||||||||
| 2017 | 2018 | |||||||
| Revenues: | ||||||||
| Total revenues | $ | — | $ | — | ||||
| Operating expenses: | ||||||||
| Research and development | 1,312 | 798 | ||||||
| General and administrative | 1,381 | 1,364 | ||||||
| Total operating expenses | 2,693 | 2,162 | ||||||
| Operating loss | (2,693 | ) | (2,162 | ) | ||||
| Other income (expense): | ||||||||
| Foreign exchange gains (losses) | (59 | ) | (4 | ) | ||||
| Interest income | 12 | 69 | ||||||
| Other income, net | 879 | 566 | ||||||
| Total other income (expense), net | 832 | 631 | ||||||
| Loss from continuing operations before taxes | (1,861 | ) | (1,531 | ) | ||||
| Income tax benefit | 306 | 182 | ||||||
| Net loss | (1,555 | ) | (1,349 | ) | ||||
| Dividend on convertible exchangeable preferred shares | (50 | ) | (50 | ) | ||||
| Net loss applicable to common shareholders | $ | (1,605 | ) | $ | (1,399 | ) | ||
| Basic and diluted earnings per common share: | ||||||||
| Net loss per share – basic and diluted | $ | (0.38 | ) | $ | (0.12 | ) | ||
| Weighted average common shares outstanding | 4,271,324 | 11,997,447 | ||||||
| CYCLACEL PHARMACEUTICALS, INC. | ||||||
| CONSOLIDATED BALANCE SHEET | ||||||
| (In $000s, except share, per share, and liquidation preference amounts) | ||||||
| December 31, 2017 |
March 31, 2018 |
|||||
| ASSETS | ||||||
| Current assets: | ||||||
| Cash and cash equivalents | $ | 23,910 | $ | 21,725 | ||
| Prepaid expenses and other current assets | 2,064 | 3,007 | ||||
| Total current assets | 25,974 | 24,732 | ||||
| Property, plant and equipment (net) | 29 | 45 | ||||
| Total assets | $ | 26,003 | $ | 24,777 | ||
| LIABILITIES AND STOCKHOLDERS’ EQUITY | ||||||
| Current liabilities: | ||||||
| Accounts payable | $ | 1,558 | $ | 1,949 | ||
| Accrued and other current liabilities | 2,555 | 2,309 | ||||
| Total current liabilities | 4,113 | 4,258 | ||||
| Other liabilities | 124 | 124 | ||||
| Total liabilities | 4,237 | 4,382 | ||||
| Stockholders’ equity | 21,766 | 20,395 | ||||
| Total liabilities and stockholders’ equity | $ | 26,003 | $ | 24,777 | ||
SOURCE: Cyclacel Pharmaceuticals, Inc.