Full Press Release Details
CYCLACEL PHARMACEUTICALS REPORTS FIRST
QUARTER 2017 FINANCIAL RESULTS
Conference Call Scheduled May 11, 2017 at 4:30 p.m. EDT -
Berkeley Heights, NJ, May 11, 2017
- 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 first quarter ended March 31, 2017.
The Company's net loss applicable
to common shareholders for the three months ended March 31, 2017 was $1.6 million, or $0.38 per share, compared to net loss applicable
to common shareholders of $3.1 million, or $1.04 per share, for the first quarter of 2016. As of March 31, 2017, cash and cash
equivalents totaled $12.7 million.
"Our development priorities going
forward are our transcriptional regulation and DNA damage response clinical stage programs," said Spiro Rombotis, President
and Chief Executive Officer of Cyclacel. "In the Phase 1 study of our CYC065 CDK inhibitor in patients with solid tumors,
we are close to establishing the recommended Phase 2 dose. Biomarker analysis shows evidence of target engagement and preliminary
clinical activity. In parallel, we are reviewing with investigators study designs to test CYC065 in combination with approved agents
in hematological indications. We are expanding our BRCA positive, sapacitabine and CDK inhibitor study to evaluate patients with
ovarian and pancreatic cancers in addition to breast. We look forward to reporting our progress with these programs and the outcome
of our final analysis of SEAMLESS data."
Quarter and Recent Highlights
Transcriptional regulation program:
cyclin dependent kinase (CDK) inhibitor
200 Connell Drive, Suite 1500, Berkeley Heights, NJ 07922, USA Tel +1 908
517 7330 Fax +1 866 271 3466
1 James Lindsay Place, Dundee, DD1 5JJ, UK Tel
+44 1382 206 062 Fax +44 1382 206 067
DNA damage response program
SEAMLESS study in acute myeloid
PLK inhibitor CYC140
During the quarter, Cyclacel announced a poster presentation
at the American Association for Cancer Research (AACR) 2017 Annual Meeting. The poster, titled "The novel PLK1 inhibitor,
CYC140: Identification of pharmacodynamic markers, sensitive target indications and potential combinations", detailed
Cyclacel's preclinical study to identify sensitive target indications including acute leukemia and esophageal cancer. The
data demonstrated antitumor activity of CYC140 in preclinical xenograft models of acute leukemia and solid tumors, including esophageal
cancer, with tumor growth delay, tumor regression and cures being observed. In addition, several pharmacodynamic markers were identified,
and activity was demonstrated in a majority of malignant cell lines derived from AML, acute lymphoblastic leukemia (ALL) and esophageal
Financial highlights
As of March 31, 2017, cash and cash
equivalents totaled $12.7 million, compared to $16.5 million as of December 31, 2016. The decrease of $3.8 million was due to net
cash used in operating activities. Net proceeds of approximately $1.0 million were received in April 2017 from the sale of common
stock through the Company's at the market facility.
There were no revenues for the three
months ended March 2017 compared to $0.1 million for the same period of the previous year. The revenue is related to previously
awarded, UK government grants being recognized over the period to progress IND-directed preclinical development of CYC140, a novel,
PLK-1 inhibitor, which was completed in November 2016.
Research and development expenses
were $1.3 million compared to $2.5 million for the same period in 2016. The decrease was primarily due to reduced study and clinical
supply costs associated with completion of the SEAMLESS study and 2016 expenditure related the development of CYC140.
General and administrative expenses were
$1.4 million for each of the three months ended March 31, 2016 and 2017.
Other income, net for the three months
ended March 31, 2017, was $0.8 million, compared to $0.2 million for the same period of the previous year. The increase is primarily
related to income received under an Asset Purchase Agreement with Life Technologies Corporation, or LTC, (formerly Invitrogen Corporation),
in respect of certain assets and intellectual property sold by the Company to LTC in December 2005.
The United Kingdom research &
tax credit was $0.3 million for the three months ended March 31, 2017 compared to $0.5 million for the same period in 2016.
The cash receipt for the 2016 tax credit of approximately $2.0 million is expected to be received in the second quarter of 2017.
After taking into account the expected $2.0 million cash receipt
above and sales of common stock totaling $1.0 million from the at the market facility, pro forma cash at March 31, 2017
is approximately $15.7 million. The Company expects current pro forma cash to fund operations and ongoing programs to the
Net loss for the three months ended March 31, 2017 was $1.6
million compared to $3.0 million for the same period in 2016.
Conference call information:
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
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,
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 is analyzing stratified and exploratory
subgroups from a Phase 3 study of sapacitabine in elderly patients with AML. 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
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 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.
| Company: | Paul McBarron, (908) 517-7330, pmcbarron@cyclacel.com |
| Investor Relations: | Russo Partners LLC, Alexander Fudukidis, (646) 942-5632, alex.fudukidis@russopartnersllc.com |