BERKELEY HEIGHTS, N.J., Nov. 09, 2017 (GLOBE NEWSWIRE) -- Cyclacel Pharmaceuticals, Inc. (NASDAQ:CYCC) (NASDAQ:CYCCP) ("Cyclacel" or the "Company"), a biopharmaceutical company developing oral therapies that target the various phases of cell cycle control for the treatment of cancer and other serious disorders, today reported its financial results and business highlights for the third quarter ended September 30, 2017.
The Company's net loss applicable to common shareholders for the three months ended September 30, 2017 was $8.9 million, which includes a $7.0 million charge in the quarter related to accounting for the Series A Convertible Preferred Stock issued in the July financing, or $0.91 per share, compared to net loss applicable to common shareholders of $3.0 million, or $0.86 per share, for the third quarter of 2016. As of September 30, 2017, cash and cash equivalents totaled $26.0 million.
“Following selection of a recommended Phase 2 dose, or RP2D, for our CYC065 CDK inhibitor, we are advancing our clinical programs, led by CYC065 in selected, patient populations relevant to the drug’s mechanism,” said Spiro Rombotis, President and Chief Executive Officer of Cyclacel. “In part 1 of an ongoing, Phase 1 study, CYC065 demonstrated durable target engagement and biomarker suppression at well tolerated doses in 11 out of 13 patients treated at the RP2D. Initial anticancer activity was observed in five patients, which included patients with relevant tumor molecular features. In parallel, we are progressing designs for further translational clinical studies to evaluate CYC065 in combination with venetoclax in chronic lymphocytic leukemia, or CLL; alone and with standard of care in solid tumors, in which we believe biomarker suppression may be beneficial; and in certain pediatric cancers. Data from the Phase 3 SEAMLESS study of sapacitabine have been selected for oral presentation at the American Society of Hematology, or ASH, Annual Meeting in December. The presentation will include additional data emerging from a comprehensive analysis of prespecified subgroups, e.g. low peripheral white blood cell count, which will form the basis of the Company’s consultations with regulatory authorities. Following our July offering, we project cash resources to fund currently planned programs through the end of 2019."
Transcriptional Regulation Program: CYC065 CDK inhibitor
DNA Damage Response (DDR) Program
SEAMLESS Phase 3 Study
July Underwritten Offering
Anticipated Upcoming Milestones
Revenues for the three months and year ended September 30, 2017 were $0.0 million compared to $0.2 million for the same period of the previous year.
As of September 30, 2017, cash and cash equivalents totaled $26.0 million, compared to $16.5 million as of December 31, 2016.
Research and development expenses were $1.0 million compared to $2.4 million for the same periods in 2016.
General and administrative expenses for the three months ended September 30, 2017 decreased to $1.2 million compared to $1.3 million for the same period in 2016.
Other expense, net for the three months ended September 30, 2017 were $0.0 million, compared to $0.1 million for the same period of the previous year. The increase in other income (expense) is primarily related to foreign exchange movements.
The UK research & tax credit for the quarter was $0.2 million.
Net loss for the three months September 30, 2017 was $1.9 million compared to $2.9 million for the same period in 2016.
At of the end of the quarter the company had cash of $26.0 million.
Conference call information (November 9, 2017 at 4:30 p.m. ET):
US/Canada call: (877) 493-9121 / international call: (973) 582-2750
US/Canada archive: (800) 585-8367 / international archive: (404) 537-3406
Code for live and archived conference call is 4396538
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 Cyclacel Pharmaceuticals, Inc.
Cyclacel Pharmaceuticals is a clinical-stage biopharmaceutical company using cell cycle, transcriptional regulation and DNA damage response biology to develop innovative, targeted medicines for cancer and other proliferative diseases. Cyclacel's transcriptional regulation program is evaluating CYC065, a CDK inhibitor, in patients with advanced cancers. The DNA damage response program is evaluating a sequential regimen of sapacitabine and seliciclib, a CDK inhibitor, in patients with BRCA positive, advanced solid cancers. Cyclacel's strategy is to build a diversified biopharmaceutical business focused in hematology and oncology based on a pipeline of novel drug candidates. For additional information, please visit www.cyclacel.com.
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 Securities and Exchange Commission and are available at www.sec.gov. Such forward-looking statements are current only as of the date they are made, and we assume no obligation to update any forward-looking statements, whether as a result of new information, future events or otherwise.
© Copyright 2017 Cyclacel Pharmaceuticals, Inc. All Rights Reserved. The Cyclacel logo and Cyclacel® are trademarks of Cyclacel Pharmaceuticals, Inc.
CYCLACEL PHARMACEUTICALS, INC.CONSOLIDATED BALANCE SHEETS(In $000s, except share, per share, and liquidation preference amounts)(Unaudited) December 31, September 30, 2016 2017 ASSETS Current assets: Cash and cash equivalents $16,520 $26,025 Prepaid expenses and other current assets 3,097 1,792 Total current assets 19,617 27,817 Property, plant and equipment (net) 45 34 Total assets $19,662 $27,851 LIABILITIES AND STOCKHOLDERS’ EQUITY Current liabilities: Accounts payable $2,497 $1,973 Accrued and other current liabilities 2,762 2,292 Total current liabilities 5,259 4,265 Other liabilities 130 128 Total liabilities 5,389 4,393 Commitments and contingencies Stockholders’ equity: Preferred stock, $0.001 par value; 5,000,000 shares authorized at December 31, 2016 and September 30, 2017;
SOURCE: Cyclacel Pharmaceuticals, Inc.