Investors
News Release
Cyclacel Pharmaceuticals Reports Fourth Quarter and Full Year 2017 Financial Results
Mar 28 2018
“We are greatly encouraged by our clinical progress in 2017, particularly in our transcriptional regulation program with CYC065, our lead CDK inhibitor candidate,” said
Fourth Quarter and Full-Year Highlights
Drug Development
Transcriptional Regulation Program: CYC065 CDK Inhibitor
In part 1 of an ongoing, first-in-human, single agent, ascending dose, Phase 1 study, prolonged reduction of Mcl-1 was observed in 11 out of 13 evaluable 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 5 patients, of which 4 were treated at the RP2D and 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. The trial is being conducted at the
The protocol for the Phase 1b study of a combination regimen of CYC065 and venetoclax in patients with relapsed or refractory CLL has been submitted to the
Discussions with principal investigators and/or cooperative groups progressed with the objective of evaluating CYC065 in both pediatric and adult patients with solid tumors. The Company is discussing with an investigator cooperative group a potential evaluation of CYC065 in patients with neuroblastoma, a mostly pediatric, life-threatening malignancy, frequently associated with MYCN amplification.
In another study, to be conducted as an investigator sponsored trial, CYC065 will be evaluated in adult and pediatric patients with leukemias, including acute myeloid leukemia, or AML, acute lymphocytic leukemia, or ALL, and in particular those with mixed lineage leukemia rearrangements, or MLL-r.
Preclinical data on the molecular rationale and therapeutic potential of CYC065 included an article published in the
DNA Damage Response (DDR) Program
In collaboration with an academic center and a pharmaceutical company we have developed a protocol for a Phase 1b/2 investigator-sponsored trial to evaluate safety and efficacy of a combination regimen of an approved PARP inhibitor and sapacitabine in patients with BRCA mutant breast cancer.
Enrollment has been completed in an extension of part 1 of the Phase 1 study evaluating a combination regimen of sapacitabine and seliciclib, Cyclacel’s first generation CDK inhibitor, in an enriched population of approximately 20 patients with BRCA positive advanced breast cancer. An ongoing part 3 of this study is testing a revised dosing schedule in additional patients, including BRCA positive, patients with breast, ovarian and pancreatic cancers.
SEAMLESS Phase 3 Study
Data from the SEAMLESS Phase 3 study of sapacitabine in elderly patients with AML were the subject of an oral presentation in
The Company has completed further statistical and exploratory analyses of the results from the SEAMLESS study and is preparing briefing documents for submission to regulatory authorities with the objective of determining a potential regulatory pathway for sapacitabine in AML.
PLK1 Inhibitor; CYC140
At the 2017 AACR Annual Meeting, the Company presented preclinical data outlining the potential therapeutic utility of CYC140, a novel, polo-like kinase (PLK) 1 inhibitor, alone and in synergistic drug combinations, for the treatment of esophageal cancer and acute leukemia.
Investigator-Sponsored Trials (ISTs): Seliciclib in Rheumatoid Arthritis (RA)
The Independent Data Monitoring Committee, or IDMC, for the “TRAFIC” trial sponsored by the
Corporate Developments
The Company raised net proceeds of approximately
Cyclacel received notice from the
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 the Phase 1b/2 IST of a combination regimen of an approved PARP inhibitor and sapacitabine in patients with BRCA mutant breast cancer
- Start enrollment in the Phase 1b/2 IST of CYC065 in pediatric patients with neuroblastoma
- Update mature data from the part 1 extension of the sapacitabine and seliciclib combination in patients with BRCA positive advanced breast and complete part 3 enrollment of the sapacitabine and seliciclib combination in patients with BRCA positive, breast, ovarian and pancreatic cancers
- Submit CYC140, PLK1 inhibitor, IND application
- Conduct regulatory authority meetings regarding the SEAMLESS study of sapacitabine in AML
Financial Highlights
As of
There were no revenues for the three months and year ended
Research and development expenses were
General and administrative expenses for the three months and year ended
Other income (expense), net for the three months and year ended
Net loss for the three months and year ended
Conference call information:
US/
US/
Code for live and archived conference call is 4857905
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 (LOSS) | |||||||||
| (In $000s, except share and per share amounts) | |||||||||
| Year Ended December 31, | |||||||||
| 2016 | 2017 | ||||||||
| Revenues: | |||||||||
| Grant revenue | $ | 843 | $ | - | |||||
| Operating expenses: | |||||||||
| Research and development | 9,477 | 4,237 | |||||||
| General and administrative | 5,516 | 5,254 | |||||||
| Total operating expenses | 14,993 | 9,491 | |||||||
| Operating loss | (14,150 | ) | (9,491 | ) | |||||
| Other income (expense): | |||||||||
| Foreign exchange gains (losses) | 273 | (39 | ) | ||||||
| Interest income | 37 | 118 | |||||||
| Other income, net | 66 | 949 | |||||||
| Total other income (expense), net | 376 | 1,028 | |||||||
| Loss from continuing operations before taxes | (13,774 | ) | (8,463 | ) | |||||
| Income tax benefit | 1,983 | 993 | |||||||
| Net loss | (11,791 | ) | (7,470 | ) | |||||
| Dividend on convertible exchangeable preferred shares | (200 | ) | (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 | $ | (11,991 | ) | $ | (14,846 | ) | |||
| Basic and diluted earnings per common share: | |||||||||
| Net loss per share – basic and diluted | $ | (3.50 | ) | $ | (1.95 | ) | |||
| Weighted average common shares outstanding | 3,424,976 | 7,631,152 | |||||||
| CYCLACEL PHARMACEUTICALS, INC. | |||||||||
| CONSOLIDATED BALANCE SHEET | |||||||||
| (In $000s, except share, per share, and liquidation preference amounts) | |||||||||
| December 31, | |||||||||
| 2016 | 2017 | ||||||||
| ASSETS | |||||||||
| Current assets: | |||||||||
| Cash and cash equivalents | $ | 16,520 | $ | 23,910 | |||||
| Prepaid expenses and other current assets | 3,097 | $ | 2,064 | ||||||
| Total current assets | 19,617 | $ | 25,974 | ||||||
| Property and equipment, net | 45 | $ | 29 | ||||||
| Total assets | $ | 19,662 | $ | 26,003 | |||||
| LIABILITIES AND STOCKHOLDERS’ EQUITY | |||||||||
| Current liabilities: | |||||||||
| Accounts payable | $ | 2,497 | $ | 1,558 | |||||
| Accrued and other current liabilities | 2,762 | $ | 2,555 | ||||||
| Total current liabilities | 5,259 | $ | 4,113 | ||||||
| Other liabilities | 130 | $ | 124 | ||||||
| Total liabilities | 5,389 | $ | 4,237 | ||||||
| Commitments and contingencies (Note 9) | |||||||||
| Stockholders’ equity: | |||||||||
| Preferred stock, $0.001 par value; 5,000,000 shares authorized at December 31, 2016 and December 31, 2017; | |||||||||
| 6% Convertible Exchangeable preferred stock; 335,273 shares issued and outstanding at December 31, 2016 and December 31, 2017. Aggregate preference in liquidation of $4,006,512 at December 31, 2016 and December 31, 2017 | — | — | |||||||
| Series A convertible preferred stock; 0 shares and 264 shares issued and outstanding at December 31, 2016 and December 31, 2017, respectively | — | — | |||||||
| Common stock, $0.001 par value; 100,000,000 shares authorized at December 31, 2016 and December 31, 2017; 4,256,829 and 11,997,447 shares issued and outstanding at December 31, 2016 and December 31, 2017, respectively. | 4 | 12 | |||||||
| Additional paid-in capital | 350,051 | $ | 365,057 | ||||||
| Accumulated other comprehensive loss | (743 | ) | $ | (794 | ) | ||||
| Accumulated deficit | (335,039 | ) | $ | (342,509 | ) | ||||
| Total stockholders’ equity | 14,273 | $ | 21,766 | ||||||
| Total liabilities and stockholders’ equity | $ | 19,662 | $ | 26,003 | |||||
SOURCE: Cyclacel Pharmaceuticals, Inc.