Full Press Release Details
CYCLACEL PHARMACEUTICALS
REPORTS 3rd QUARTER 2016 FINANCIAL RESULTS
Call Scheduled November 14, 2016 at 4:30 p.m. ET
BERKELEY HEIGHTS, NJ, Nov. 14,
2016 - 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 financial results and business highlights for the third quarter ended September
The Company's net loss applicable
to common shareholders for the third quarter ended September 30, 2016 was $3.0 million, or $0.86 per basic and diluted share, compared
to net loss applicable to common shareholders of $2.8 million, or $0.95 per basic and diluted share for the third quarter ended
September 30, 2015. As of September 30, 2016, cash and cash equivalents totaled $18.0 million.
a Phase 3 study of oral sapacitabine capsules, represents one of the largest clinical trials conducted in elderly patients with
AML who are unfit or refused intensive chemotherapy. Following completion of follow-up at the beginning of the quarter, we have
been conducting data validation operations," said Spiro Rombotis, President and
Chief Executive Officer of Cyclacel. "We are pleased to report that this process is nearing completion following which the
database will be locked and transferred to our statistical analysis vendor. We anticipate reporting top line results late in the
fourth quarter of 2016 or in early 2017."
"The collection and processing
of SEAMLESS Phase 3 data represent many years of effort in our search to offer a new treatment regimen for this older patient population.
We will soon analyze the data and determine whether the results warrant regulatory submissions," said Dr. Judy Chiao, VP,
Clinical Development and Regulatory Affairs. "We are grateful to the patients, their families, the investigators and
their teams for their valuable contributions to this study."
"During the quarter data presented
at a pediatric cancer meeting demonstrated that CYC065, our second generation Cyclin Dependent Kinase (CDK) inhibitor, prolonged
survival in MYCN-addicted neuroblastoma models. The data further validate the mechanism of CYC065 and provide a rationale
for clinical investigation in neuroblastoma with MYCN amplification, a major oncogenic driver of this childhood cancer.
MYC family proteins are important therapeutic targets in other oncology indications, including certain solid tumors, leukemias
and lymphomas. Early clinical and preclinical data from our DNA damage response program suggest that our transcriptional CDK inhibitors
may have a synergistic effect with other anticancer agents, including sapacitabine. We look forward to reporting new data from
our ongoing clinical studies of sapacitabine and seliciclib in BRCA positive patients and of CYC065 in patients with solid tumors,"
continued Mr. Rombotis.
DNA damage response program
Cyclin dependent kinase (CDK) inhibitor program
KEY UPCOMING MILESTONES
DNA damage response program
CDK Inhibitor Program
Sapacitabine in myelodysplastic
THIRD QUARTER 2016 FINANCIAL RESULTS
and cash equivalents totaled $18.0 million as of September 30, 2016 compared to $20.4 million at December 31, 2015. Approximately
$5.2 million was raised from the sale of common stock through the Company's at-the-market facility with FBR Capital Markets.
A further $1.5 million was received in October 2016 through this facility, resulting in a proforma cash balance as of September
30, 2016 of $19.5 million. Based on current plans, the Company estimates that it has capital resources to fund operations through
the second quarter of 2018.
Revenue for the three months ended
September 30, 2016 was $0.2 million, compared to $0.7 million for the same period of the previous year, with the decrease primarily
related to grant revenue related to CYC065, for which the grant ended in December 2015.
Research and development expenses
were $2.4 million for the three months ended September 30, 2016 and $2.9 million for the three months ended September 30, 2015.
General and administrative expenses
were $1.3 million for the three months ended September 30, 2016 and $1.2 million for the three months ended September 30, 2015.
CONFERENCE CALL AND WEBCAST INFORMATION:
Cyclacel will conduct a conference
call on November 14, 2016 at 4:30 p.m. Eastern Time to review the third quarter 2016 results. Conference call and webcast details
Conference call information:
US/Canada call: (877) 493-9121/ international call: (973) 582-2750
US/Canada archive: (800) 585-8367 / international archive:
Code for live and archived conference call is 14223368
For the live and archived webcast,
please visit the Corporate Presentations and Events 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 control and DNA damage response biology to develop innovative, targeted medicines for
cancer and other proliferative diseases. The SEAMLESS randomized Phase 3 trial of sapacitabine as front-line treatment for AML
in the elderly under an SPA with FDA has completed enrollment and follow-up. Cyclacel's pipeline includes an oral combination
of seliciclib (CDK inhibitor) and sapacitabine in Phase 1 in advanced solid tumors, including patients with BRCA mutations; sapacitabine
in Phase 2 in MDS; and CYC065 (CDK inhibitor) in Phase 1 in solid tumors with potential utility based on preclinical data also
in hematological malignancies. Cyclacel's strategy is to build a diversified biopharmaceutical business focused in hematology
and oncology based on a pipeline of novel drug candidates. Please visit www.cyclacel.com for more information.
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 |
Copyright 2016 Cyclacel Pharmaceuticals,
CYCLACEL PHARMACEUTICALS, INC.
CONSOLIDATED STATEMENTS OF OPERATIONS
(In $000s, except share and per share
| Three Months Ended September 30, | Nine Months Ended September 30, | |||||||||||||||
| 2015 | 2016 | 2015 | 2016 | |||||||||||||
| Revenues: | ||||||||||||||||
| Grant revenue | $ | 462 | $ | 205 | $ | 1,270 | $ | 566 | ||||||||
| Collaboration and research and development revenue | 253 | - | 253 | - | ||||||||||||
| Total revenues | 715 | 205 | 1,523 | 566 | ||||||||||||
| Operating expenses: | ||||||||||||||||
| Research and development | 2,904 | 2,409 | 9,826 | 7,545 | ||||||||||||
| General and administrative | 1,205 | 1,273 | 4,006 | 4,002 | ||||||||||||
| Total operating expenses | 4,109 | 3,682 | 13,832 | 11,547 | ||||||||||||
| Operating loss | (3,394 | ) | (3,477 | ) | (12,309 | ) | (10,981 | ) | ||||||||
| Other income (expense): | ||||||||||||||||
| Change in valuation of financial instruments associated with stock purchase agreement | (27 | ) | - | (51 | ) | - | ||||||||||
| Foreign exchange (loss) gain | (219 | ) | 51 | (354 | ) | 369 | ||||||||||
| Interest income | 2 | 8 | 5 | 31 | ||||||||||||
| Other income, net | 13 | 18 | 95 | 56 | ||||||||||||
| Total other income (expense) | 207 | 77 | (305 | ) | 456 | |||||||||||
| Loss before taxes | (3,187 | ) | (3,400 | ) | (12,614 | ) | (10,525 | ) | ||||||||
| Income tax benefit | 478 | 454 | 1,646 | 1,573 | ||||||||||||
| Net loss | (2,709 | ) | (2,946 | ) | (10,968 | ) | (8,952 | ) | ||||||||
| Dividend on convertible exchangeable preferred shares | (50 | ) | (50 | ) | (150 | ) | (150 | ) | ||||||||
| Net loss applicable to common shareholders | $ | (2,759 | ) | $ | (2,996 | ) | $ | (11,118 | ) | $ | (9,102 | ) | ||||
| Basic and diluted earnings per common share: | ||||||||||||||||
| Net loss per share - basic and diluted | $ | (0.95 | ) | $ | (0.86 | ) | $ | (4.20 | ) | $ | (2.89 | ) | ||||
| Weighted average common shares outstanding | 2,889,893 | 3,473,696 | 2,645,159 | 3,145,730 |
CYCLACEL PHARMACEUTICALS, INC.
CONSOLIDATED BALANCE SHEETS
(In $000s, except share, per share,
and liquidation preference amounts)
| December 31, | September 30, | |||||||
| 2015 | 2016 | |||||||
| (Unaudited) | ||||||||
| ASSETS | ||||||||
| Current assets: | ||||||||
| Cash and cash equivalents | $ | 20,440 | $ | 18,029 | ||||
| Prepaid expenses and other current assets | 4,051 | 4,521 | ||||||
| Current assets of discontinued operations | 75 | 29 | ||||||
| Total current assets | 24,566 | 22,579 | ||||||
| Property, plant and equipment (net) | 198 | 73 | ||||||
| Total assets | $ | 24,764 | $ | 22,652 | ||||
| LIABILITIES AND STOCKHOLDERS' EQUITY | ||||||||
| Current liabilities: | ||||||||
| Accounts payable | $ | 1,940 | $ | 1,979 | ||||
| Accrued and other current liabilities | 3,738 | 3,562 | ||||||
| Current liabilities of discontinued operations | 75 | 29 | ||||||
| Total current liabilities | 5,753 | 5,570 | ||||||
| Other liabilities | 176 | 141 | ||||||
| Total liabilities | 5,929 | 5,711 | ||||||
| Total stockholders' equity | 18,835 | 16,941 | ||||||
| Total liabilities and stockholders' equity | $ | 24,764 | $ | 22,652 |
Source: Cyclacel Pharmaceuticals, Inc.