Full Press Release Details
CYCLACEL PHARMACEUTICALS REPORTS SECOND
QUARTER 2014 FINANCIAL RESULTS
- Conference Call Scheduled
August 12, 2014 at 4:30 p.m. EDT -
Berkeley Heights, NJ, August 12, 2014
- 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, 2014.
The Company's net loss applicable
to common shareholders for the second quarter ended June 30, 2014 was $4.9 million, or $0.22 per basic and diluted share, compared
to net income applicable to common shareholders of $1.4 million, or $0.10 per basic and diluted share, which included a non-routine
income item of $5.5 million, for the second quarter ended June 30, 2013. As of June 30, 2014, cash and cash equivalents totaled
pleased to report that we have enrolled over 70% of the required number of patients in our Phase 3 SEAMLESS trial in front-line
AML. At present we have approximately 90 study centers open for enrollment in the US and Europe with additional sites to be added,"
said Spiro Rombotis, President and Chief Executive Officer of Cyclacel. "We expect to complete SEAMLESS enrollment around
the end of 2014 with data readout in the second half of 2015. Having surpassed enrollment of 300 patients, we expect the study's
Data Safety Monitoring Board (DSMB) to perform the fourth periodic safety review once 60 days of follow-up have been observed.
The next DSMB review will be an interim analysis for futility and will occur after 212 events have been observed. As indicated
previously, SEAMLESS is funded to completion. Following Phase 2 data for sapacitabine reported at ASH 2013, demonstrating a near
doubling of expected median survival of older patients with MDS after treatment failure of hypomethylating agents, we disclosed
during ASCO 2014 our proposed randomized, controlled trial design in this underserved patient population. We are currently conducting
assessment of feasibility for this study and will provide further information once the findings become available."
in SEAMLESS, pivotal, Phase 3 study for first-line treatment in elderly patients with acute myeloid leukemia (AML):
for patients with myelodysplastic syndromes (MDS) after treatment failure of front-line hypomethylating agents
2014 Financial Results
Revenue for the three months ended June
30, 2014, was $0.4 million compared to $0.3 million for the same period of the previous year. The revenue is related to previously
awarded grants from the UK government being recognized over the period to progress CYC065, a Cyclin Dependent Kinase inhibitor,
to IND and to complete IND-directed preclinical development of CYC140, a novel, orally available, Polo-Like Kinase 1 (PLK 1) inhibitor.
Research and Development Expenses
Research and development expenses increased
to $4.5 million for the three months ended June 30, 2014, compared to $2.6 million for the same period in the previous year. The
increase was primarily due to study and site startup costs associated with the expansion of the SEAMLESS registration study into
General and Administrative Expenses
General and administrative expenses for
the three months ended June 30, 2014 decreased to $1.4 million compared to $1.8 million for the same period in 2013. The decrease
was primarily due to higher legal and professional fees during the three months ended June 30, 2013.
Cyclacel's Key Milestones for
Conference call and Webcast Information:
Cyclacel will conduct a conference call
on August 12, 2014 at 4:30 p.m. Eastern Time to review the second quarter 2014 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: (404) 537-3406
Code for live and archived conference
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, Inc.
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 carrying gBRCA 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.
Contacts for Cyclacel Pharmaceuticals,
Company: Paul McBarron, (908) 517-7330,
Investor Relations: Russo Partners LLC,
Robert Flamm, (212) 845-4226, robert.flamm@russopartnersllc.com
Copyright 2014 Cyclacel Pharmaceuticals,
CYCLACEL PHARMACEUTICALS, INC.
CONDENSED CONSOLIDATED STATEMENTS
(In $000s, except share and per share
| Three Months Ended June 30, | ||||||||
| 2013 | 2014 | |||||||
| Revenues: | ||||||||
| Grant revenue | $ | 264 | $ | 356 | ||||
| Total revenues | 264 | 356 | ||||||
| Operating expenses: | ||||||||
| Research and development | 2,631 | 4,545 | ||||||
| General and administrative | 1,787 | 1,386 | ||||||
| Total operating expenses | 4,418 | 5,931 | ||||||
| Operating loss | (4,154 | ) | (5,575 | ) | ||||
| Other income (expense): | ||||||||
| Change in valuation of financial instruments associated with stock purchase agreement | - | (64 | ) | |||||
| Change in valuation of liabilities measured at fair value | - | 20 | ||||||
| Foreign exchange losses | (101 | ) | (43 | ) | ||||
| Interest income | 3 | 1 | ||||||
| Other income, net | 5,500 | 26 | ||||||
| Total other income (expense) | 5,402 | (60 | ) | |||||
| Income (loss) from continuing operations before taxes | 1,248 | (5,635 | ) | |||||
| Income tax benefit | 230 | 816 | ||||||
| Net income (loss) from continuing operations | 1,478 | (4,819 | ) | |||||
| Discontinued operations: | ||||||||
| Income from discontinued operations | 24 | 10 | ||||||
| Income tax on discontinued operations | (10 | ) | (3 | ) | ||||
| Net income from discontinued operations | 14 | 7 | ||||||
| Net income (loss) | 1,492 | (4,812 | ) | |||||
| Deemed dividend on convertible exchangeable preferred shares | - | - | ||||||
| Dividend on convertible exchangeable preferred shares | (63 | ) | (50 | ) | ||||
| Net income (loss) applicable to common shareholders | $ | 1,429 | $ | (4,862 | ) | |||
| Basic earnings per common share: | ||||||||
| Net income (loss) per share, continuing operations | $ | 0.10 | $ | (0.22 | ) | |||
| Net income (loss) per share, discontinued operations | $ | 0.00 | $ | 0.00 | ||||
| Net income (loss) per share applicable to common shareholders | $ | 0.10 | $ | (0.22 | ) | |||
| Diluted earnings per common share: | ||||||||
| Net income (loss) per share, continuing operations | $ | 0.10 | $ | (0.22 | ) | |||
| Net income (loss) per share, discontinued operations | $ | 0.00 | $ | 0.00 | ||||
| Net income (loss) per share applicable to common shareholders | $ | 0.10 | $ | (0.22 | ) | |||
| Weighted average shares of common stock outstanding: | ||||||||
| Basic | 13,885,442 | 22,582,283 | ||||||
| Diluted | 13,927,371 | 22,582,283 |
CYCLACEL PHARMACEUTICALS, INC.
CONDENSED CONSOLIDATED BALANCE SHEETS
(In $000s, except share, per share,
and liquidation preference amounts)
| December 31, | June 30, | |||||||
| 2013 | 2014 | |||||||
| (Unaudited) | ||||||||
| ASSETS | ||||||||
| Current assets: | ||||||||
| Cash and cash equivalents | $ | 31,146 | $ | 33,456 | ||||
| Prepaid expenses and other current assets | 3,388 | 3,422 | ||||||
| Current assets of discontinued operations | 639 | 403 | ||||||
| Total current assets | 35,173 | 37,281 | ||||||
| Property and equipment (net) | 275 | 305 | ||||||
| Long-term assets of discontinued operations | 72 | 24 | ||||||
| Total assets | $ | 35,520 | $ | 37,610 | ||||
| LIABILITIES AND STOCKHOLDERS' EQUITY | ||||||||
| Current liabilities: | ||||||||
| Accounts payable | $ | 2,545 | $ | 4,543 | ||||
| Accrued and other current liabilities | 4,431 | 3,095 | ||||||
| Other liabilities measured at fair value | 20 | - | ||||||
| Current liabilities of discontinued operations | 260 | 145 | ||||||
| Total current liabilities | 7,256 | 7,783 | ||||||
| Other liabilities | 241 | 238 | ||||||
| Total liabilities | 7,497 | 8,021 | ||||||
| Commitments and contingencies | - | - | ||||||
| Stockholders' equity: | ||||||||
| Preferred stock, $0.001 par value; 5,000,000 shares authorized at December 31, 2013 and June 30, 2014; 335,273 shares issued and outstanding at December 31, 2013 and June 30, 2014. Aggregate preference in liquidation of $3,989,749 at December 31, 2013 and June 30, 2014. | - | - | ||||||
| Common stock, $0.001 par value; 100,000,000 shares authorized at December 31, 2013 and June 30, 2014; 19,369,332 and 22,676,475 shares issued and outstanding at December 31, 2013 and June 30, 2014, respectively. | 19 | 23 | ||||||
| Additional paid-in capital | 317,543 | 328,774 | ||||||
| Accumulated other comprehensive income (loss) | (109 | ) | (97 | ) | ||||
| Accumulated deficit | (289,430 | ) | (299,111 | ) | ||||
| Total stockholders' equity | 28,023 | 29,589 | ||||||
| Total liabilities and stockholders' equity | $ | 35,520 | $ | 37,610 |
SOURCE: Cyclacel Pharmaceuticals, Inc.