Full Press Release Details
CYCLACEL PHARMACEUTICALS REPORTS THIRD
QUARTER 2017 FINANCIAL RESULTS
Call Scheduled November 9, 2017 at 4:30 p.m. ET -
Berkeley Heights, NJ, November 9,
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 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
Financial Highlights
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
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'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.
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 | |
| Company: | Paul McBarron, (908) 517-7330, pmcbarron@cyclacel.com |
| Investor Relations: | Russo Partners LLC, Alexander Fudukidis, (646) 942-562, alex.fudukidis@russopartnersllc.com |
CYCLACEL PHARMACEUTICALS, INC.
CONSOLIDATED STATEMENTS OF OPERATIONS
(In $000s, except share and per share
| Three Months Ended September 30, | Nine months Ended September 30, | |||||||||||||||
| 2016 | 2017 | 2016 | 2017 | |||||||||||||
| Revenues: | ||||||||||||||||
| Grant revenue | $ | 205 | $ | - | $ | 566 | $ | - | ||||||||
| Operating expenses: | ||||||||||||||||
| Research and development | 2,409 | 958 | 7,545 | 3,491 | ||||||||||||
| General and administrative | 1,273 | 1,154 | 4,002 | 3,802 | ||||||||||||
| Total operating expenses | 3,682 | 2,112 | 11,547 | 7,293 | ||||||||||||
| Operating loss | (3,477 | ) | (2,112 | ) | (10,981 | ) | (7,293 | ) | ||||||||
| Other income (expense): | ||||||||||||||||
| Foreign exchange gains (losses) | 51 | (22 | ) | 369 | (65 | ) | ||||||||||
| Interest income | 8 | 30 | 31 | 59 | ||||||||||||
| Other income, net | 18 | 28 | 56 | 907 | ||||||||||||
| Total other income | 77 | 36 | 456 | 901 | ||||||||||||
| Loss before taxes | (3,400 | ) | (2,076 | ) | (10,525 | ) | (6,392 | ) | ||||||||
| Income tax benefit | 454 | 219 | 1,573 | 793 | ||||||||||||
| Net loss | (2,946 | ) | (1,857 | ) | (8,952 | ) | (5,599 | ) | ||||||||
| Dividend on convertible exchangeable preferred shares | (50 | ) | (50 | ) | (150 | ) | (151 | ) | ||||||||
| Beneficial conversion feature of Series A convertible stock | - | (3,638 | ) | - | (3,638 | ) | ||||||||||
| Conversion of Series A convertible preferred stock | - | (3,373 | ) | - | (3,373 | ) | ||||||||||
| Net loss applicable to common shareholders | $ | (2,996 | ) | $ | (8,918 | ) | $ | (9,102 | ) | $ | (12,761 | ) | ||||
| Basic and diluted earnings per common share: | ||||||||||||||||
| Net loss per share - basic and diluted | $ | (0.86 | ) | $ | (0.91 | ) | $ | (2.89 | ) | $ | (2.06 | ) | ||||
| Weighted average common shares outstanding | 3,473,696 | 9,835,441 | 3,145,730 | 6,200,783 |
CYCLACEL PHARMACEUTICALS, INC.
CONSOLIDATED BALANCE SHEETS
(In $000s, except share, per share, and
liquidation preference amounts)
| 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; 6% Convertible Exchangeable preferred stock; 335,273 shares issued and outstanding at December 31, 2016 and September 30, 2017. Aggregate preference in liquidation of $4,006,512 at December 31, 2016 and September 30, 2017. | - | - | ||||||
| Series A preferred stock; 0 shares and 664 shares issued and outstanding at December 31, 2016 and September 30, 2017 respectively. | - | - | ||||||
| Common stock, $0.001 par value; 100,000,000 shares authorized at December 31, 2016 and September 30, 2017; 4,256,829 and 11,697,021 shares issued and outstanding at December 31, 2016 and September 30, 2017 respectively. | 4 | 12 | ||||||
| Additional paid-in capital | 350,051 | 364,843 | ||||||
| Accumulated other comprehensive loss | (743 | ) | (762 | ) | ||||
| Accumulated deficit | (335,039 | ) | (340,635 | ) | ||||
| Total stockholders' equity | 14,273 | 23,458 | ||||||
| Total liabilities and stockholders' equity | $ | 19,662 | $ | 27,851 |
SOURCE: Cyclacel Pharmaceuticals, Inc.