Full Press Release Details
Cyclacel Pharmaceuticals
Reports Second Quarter 2015 Financial Results
Call Scheduled August 11, 2015 at 4:30 p.m. EDT
BERKELEY HEIGHTS, N.J., Aug. 11, 2015
- 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 second quarter ended June 30, 2015.
The Company's net loss applicable
to common shareholders for the second quarter ended June 30, 2015 was $3.4 million, or $0.10 per basic and diluted share, compared
to a net loss income applicable to common shareholders of $4.9 million, or $0.22 per basic and diluted share for the second quarter
ended June 30, 2014. As of June 30, 2015, cash and cash equivalents totaled $26.9 million.
"SEAMLESS continues to progress
towards final data read-out," said Spiro Rombotis, President and Chief Executive Officer of Cyclacel. "There are now
approximately 13% of events remaining to occur and we expect to report top-line data during the second half of 2015 through the
first half of 2016. Following unblinding and analysis of the SEAMLESS data, we will determine their suitability for submission
to regulators in the U.S. and Europe. Additionally, in the Phase 1 study of our all-oral combination of sapacitabine with our first-generation
CDK2/9 inhibitor, seliciclib, we reported updated data in heavily pretreated cancer patients with BRCA mutations. The data showed
a 55% overall response rate with patients achieving durable benefit after multiple cycles of therapy, including a breast cancer
patient who has received to date over 60 cycles. These promising data are encouraging us to explore this regimen further. Our next
generation CDK2/9 inhibitor, CYC065, received institutional review board approval for a first-in-human, Phase 1 study in advanced
solid tumors and we expect to start treating patients shortly. CYC065 has demonstrated increased potency compared to seliciclib.
Based on published preclinical efficacy data, we plan to develop CYC065 as a targeted anticancer agent in both hematological and
solid cancers. In addition to our focus on SEAMLESS, we have continued to make progress with our other programs, while ensuring
we have sufficient resources to deliver on our key milestones and execute on our business strategy."
Sapacitabine in SEAMLESS, pivotal,
Phase 3 study for first-line treatment in elderly patients with acute myeloid leukemia (AML):
Sapacitabine and seliciclib,
all-oral combination in Phase 1 study in patients with advanced solid tumors
Cyclin Dependent Kinase (CDK)
Second Quarter 2015 Financial Results
Revenue for the three months ended
June 30, 2015, was $0.3 million compared to $0.4 million for the same period of the previous year. The revenue is related to grants
from the European Union and the Biomedical Catalyst of the United Kingdom government.
Research and Development Expenses
Research and development expenses
were $2.6 million for the three months ended June 30, 2015, compared to $4.5 million for the same period in the previous year.
The decrease was primarily a result of reduced expenditure in the SEAMLESS Phase 3 study this quarter compared to the same period
General and Administrative Expenses
General and administrative expenses
for the three months ended June 30, 2015 remained relatively flat at $1.3 million compared to $1.4 million for the same period
Conference call and Webcast Information:
Cyclacel will conduct a conference
call on August 11, 2015 at 4:30 p.m. Eastern Time to review the second quarter 2015 results. Conference call and webcast details
Conference call information:
US/Canada call: (877) 493-9121/ international call: (973)
US/Canada archive: (800) 585-8367 / international archive:
Code for live and archived conference call is 95466148
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 is a biopharmaceutical company
developing oral therapies that target the various phases of cell cycle control for the treatment of cancer and other serious diseases.
Sapacitabine, Cyclacel's most advanced product candidate, is the subject of SEAMLESS, a Phase 3 trial being conducted under an
SPA with the FDA as front-line treatment for acute myeloid leukemia (AML) in the elderly, and other studies for myelodysplastic
syndromes (MDS), chronic lymphocytic leukemia (CLL) and solid tumors including breast, lung, ovarian and pancreatic cancer and
in particular those patients carrying BRCA mutations. Cyclacel's strategy is to build a diversified biopharmaceutical business
focused in hematology and oncology based on a development pipeline of novel drug candidates. Please visit www.cyclacel.com
for additional 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.
CYCLACEL PHARMACEUTICALS, INC.
CONSOLIDATED STATEMENTS OF OPERATIONS
(In $000s, except share and per share
| Three Months Ended June 30, | Six Months Ended June 30, | |||||||||||||||
| 2014 | 2015 | 2014 | 2015 | |||||||||||||
| Revenues: | ||||||||||||||||
| Grant revenue | $ | 356 | $ | 296 | $ | 752 | $ | 808 | ||||||||
| Total revenues | 356 | 296 | 752 | 808 | ||||||||||||
| Operating expenses: | ||||||||||||||||
| Research and development | 4,545 | 2,580 | 8,889 | 6,922 | ||||||||||||
| General and administrative | 1,386 | 1,333 | 2,848 | 2,801 | ||||||||||||
| Total operating expenses | 5,931 | 3,913 | 11,737 | 9,723 | ||||||||||||
| Operating loss | (5,575 | ) | (3,617 | ) | (10,985 | ) | (8,915 | ) | ||||||||
| Other income (expense): | ||||||||||||||||
| Change in valuation of financial instruments associated with stock purchase agreement | (64 | ) | (4 | ) | (111 | ) | (24 | ) | ||||||||
| Change in valuation of liabilities measured at fair value | 20 | - | 20 | - | ||||||||||||
| Foreign exchange losses | (43 | ) | (195 | ) | (33 | ) | (573 | ) | ||||||||
| Interest income | 1 | 2 | 2 | 3 | ||||||||||||
| Other income, net | 26 | 62 | 26 | 82 | ||||||||||||
| Total other expense | (60 | ) | (135 | ) | (96 | ) | (512 | ) | ||||||||
| Loss from continuing operations before taxes | (5,635 | ) | (3,752 | ) | (11,081 | ) | (9,427 | ) | ||||||||
| Income tax benefit | 816 | 405 | 1,385 | 1,168 | ||||||||||||
| Net loss from continuing operations | (4,819 | ) | (3,347 | ) | (9,696 | ) | (8,259 | ) | ||||||||
| Discontinued operations: | ||||||||||||||||
| Income from discontinued operations | 10 | - | 23 | - | ||||||||||||
| Income tax on discontinued operations | (3 | ) | - | (8 | ) | - | ||||||||||
| Net income from discontinued operations | 7 | - | 15 | - | ||||||||||||
| Net loss | (4,812 | ) | (3,347 | ) | (9,681 | ) | (8,259 | ) | ||||||||
| Dividend on convertible exchangeable preferred shares | (50 | ) | (50 | ) | (100 | ) | (100 | ) | ||||||||
| Net loss applicable to common shareholders | $ | (4,862 | ) | $ | (3,397 | ) | $ | (9,781 | ) | $ | (8,359 | ) | ||||
| Basic and diluted earnings per common share: | ||||||||||||||||
| Net loss per share, continuing operations - basic and diluted | $ | (0.22 | ) | $ | (0.10 | ) | $ | (0.47 | ) | $ | (0.28 | ) | ||||
| Net income per share, discontinued operations - basic and diluted | $ | 0.00 | $ | 0.00 | $ | 0.00 | $ | 0.00 | ||||||||
| Net loss per share - basic and diluted | $ | (0.22 | ) | $ | (0.10 | ) | $ | (0.46 | ) | $ | (0.28 | ) | ||||
| Weighted average common shares outstanding | 22,582,283 | 34,388,486 | 21,064,739 | 30,250,769 |
CYCLACEL PHARMACEUTICALS, INC.
CONSOLIDATED BALANCE SHEETS
(In $000s, except share, per share,
and liquidation preference amounts)
| December 31, | June 30, | |||||||
| 2014 | 2015 | |||||||
| (Unaudited) | ||||||||
| ASSETS | ||||||||
| Current assets: | ||||||||
| Cash and cash equivalents | $ | 24,189 | $ | 26,902 | ||||
| Prepaid expenses and other current assets | 4,640 | 3,453 | ||||||
| Current assets of discontinued operations | 171 | 124 | ||||||
| Total current assets | 29,000 | 30,479 | ||||||
| Property, plant and equipment (net) | 387 | 309 | ||||||
| Total assets | $ | 29,387 | $ | 30,788 | ||||
| LIABILITIES AND STOCKHOLDERS' EQUITY | ||||||||
| Current liabilities: | ||||||||
| Accounts payable | $ | 2,792 | $ | 2,609 | ||||
| Accrued and other current liabilities | 4,626 | 3,806 | ||||||
| Current liabilities of discontinued operations | 75 | 75 | ||||||
| Total current liabilities | 7,493 | 6,490 | ||||||
| Other liabilities | 206 | 198 | ||||||
| Total liabilities | 7,699 | 6,688 | ||||||
| Commitments and contingencies | ||||||||
| Stockholders' equity: | ||||||||
| Preferred stock, $0.001 par value; 5,000,000 shares authorized at December 31, 2014 and June 30, 2015; 335,273 shares issued and outstanding at December 31, 2014 and June 30, 2015. Aggregate preference in liquidation of $3,989,749 at December 31, 2014 and June 30, 2015. | - | - | ||||||
| Common stock, $0.001 par value; 100,000,000 shares authorized at December 31, 2014 and June 30, 2015; 23,199,469 and 34,388,486 shares issued and outstanding at December 31, 2014 and June 30, 2015, respectively. | 23 | 34 | ||||||
| Additional paid-in capital | 330,962 | 341,530 | ||||||
| Accumulated other comprehensive loss | (480 | ) | (388 | ) | ||||
| Accumulated deficit | (308,817 | ) | (317,076 | ) | ||||
| Total stockholders' equity | 21,688 | 24,100 | ||||||
| Total liabilities and stockholders' equity | $ | 29,387 | $ | 30,788 |
Source: Cyclacel Pharmaceuticals, Inc.
Contacts for Cyclacel Pharmaceuticals,
Company: Paul McBarron, (908) 517-7330,
Investor Relations: Russo Partners
LLC, Robert Flamm, (212) 845-4226, robert.flamm@russopartnersllc.com