Full Press Release Details
Pharmaceuticals Reports second Quarter 2019 Financial Results
Call Scheduled August 13, 2019 at 4:30 p.m. ET -
Berkeley Heights, NJ, August 13,
2019 - Cyclacel Pharmaceuticals, Inc. (NASDAQ: CYCC, NASDAQ: CYCCP; "Cyclacel" or the "Company"), a biopharmaceutical
company developing innovative medicines based on cancer cell biology, today reported financial results and business highlights
for the second quarter 2019. The Company's net loss applicable to common shareholders for the three months ended June 30, 2019
was $1.8 million. As of June 30, 2019 cash and cash equivalents totaled $15.2 million.
"We are excited to report
new evidence of anticancer activity for CYC065. In part 2 of our Phase 1 study of CYC065 as a single agent, a patient with endometrial
cancer with MCL1 amplification treated on the fourth dose level achieved tumor shrinkage. This patient was previously treated with
liposomal doxorubicin, carboplatin, and multiple investigational therapies," said
Spiro Rombotis, President and Chief Executive Officer of Cyclacel. "Following our recent announcement of the first
patient dosed in a Phase 1/2 study with an oral combination of sapacitabine and venetoclax
in relapsed or refractory AML or MDS, we are now dosing patients in five clinical studies in pursuit
of our strategy of overcoming cancer resistance mechanisms through combinations of our candidates with approved drugs. The first
two patients in the relapsed or refractory CLL study evaluating the combination of CYC065 and venetoclax remain on treatment for
4 and 6 cycles respectively. A total of 4 patients with BRCA mutant breast cancer have been treated in the Phase 1/2 investigator
sponsored trial (IST) evaluating sapacitabine and olaparib and one patient has achieved partial response (PR). With projected cash
to the end of 2020 we look forward to delivering on multiple data outcomes from our ongoing studies."
Key Company Highlights
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
Key Upcoming Business Objectives
Financial Highlights
As of June 30, 2019, cash and cash
equivalents totaled $15.2 million compared to $17.5 million as of December 31, 2018. The decrease of $2.3 million was primarily
due to net cash used in operating activities of $6.3 million, offset by net proceeds from a Common Stock Sales Agreement with H.C.
Wainwright of $4.1m.
Research and development expenses were
$1.2 million for the three months ended June 30, 2019 compared to $1.2 million for the same period in 2018.
General and administrative expenses were
$1.2 million for the three months ended June 30, 2019 compared to $1.3 million for the same period in 2018.
Other income, net for the three months
ended June 30, 2019 was $0.2 million compared to $0.1 million for the same period of the previous year.
The United Kingdom R&D tax
credit was $0.3 million for the three months ended June 30, 2019 compared to $0.5 million for the same period in 2018.
Net loss for the three months ended June 30, 2019 was $1.8 million
compared to $1.9 million for the same period in 2018. With the projected cash-sparing benefits accruing from the MD Anderson alliance
the Company believes that cash and marketable securities, which were approximately $15.2 million as of June 30, 2019, will be sufficient
to finance operations through the end of 2020.
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 developing innovative cancer medicines based on cell cycle, transcriptional regulation and DNA damage response biology.
The transcriptional regulation program is evaluating CYC065 in combination with venetoclax in patients with relapsed or refractory
CLL and AML/MDS. The DNA damage response program is evaluating an oral combination regimen of sapacitabine and venetoclax in patients
with relapsed or refractory AML/MDS. The anti-mitotic program is evaluating CYC140, a PLK1 inhibitor, in AML/MDS patients. 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.
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 2019 Cyclacel Pharmaceuticals, Inc. All Rights
Reserved. The Cyclacel logo and Cyclacel are trademarks of Cyclacel Pharmaceuticals, Inc.
CYCLACEL PHARMACEUTICALS, INC.
CONSOLIDATED STATEMENTS OF OPERATIONS
(In $000s, except share and per share amounts)
| Three Months Ended | ||||||||
| June 30, | ||||||||
| 2018 | 2019 | |||||||
| Revenues: | ||||||||
| Total revenues | - | - | ||||||
| Operating expenses: | ||||||||
| Research and development | 1,182 | 1,153 | ||||||
| General and administrative | 1,283 | 1,184 | ||||||
| Total operating expenses | 2,465 | 2,337 | ||||||
| Operating loss | (2,465 | ) | (2,337 | ) | ||||
| Other income (expense): | ||||||||
| Foreign exchange gains (losses) | (39 | ) | 21 | |||||
| Interest income | 84 | 56 | ||||||
| Other income, net | 66 | 170 | ||||||
| Total other income (expense), net | 111 | 247 | ||||||
| Loss before taxes | (2,354 | ) | (2,090 | ) | ||||
| Income tax benefit | 502 | 307 | ||||||
| Net loss | (1,852 | ) | (1,783 | ) | ||||
| Dividend on convertible exchangeable preferred shares | (50 | ) | (50 | ) | ||||
| Net loss applicable to common shareholders | $ | (1,902 | ) | $ | (1,833 | ) | ||
| Basic and diluted earnings per common share: | ||||||||
| Net loss per share - basic and diluted | $ | (0.16 | ) | $ | (0.11 | ) | ||
| Weighted average common shares outstanding | 11,997,447 | 17,199,974 |
CYCLACEL PHARMACEUTICALS, INC.
CONSOLIDATED BALANCE SHEET
(In $000s, except share, per share, and
liquidation preference amounts)
| December 31, | June 30, | |||||||
| 2018 | 2019 | |||||||
| ASSETS | ||||||||
| Current assets: | ||||||||
| Cash and cash equivalents | $ | 17,504 | $ | 15,159 | ||||
| Prepaid expenses and other current assets | 2,283 | 2,991 | ||||||
| Total current assets | 19,787 | 18,150 | ||||||
| Property and equipment, net | 36 | 29 | ||||||
| Right-of-use lease asset | - | 1,285 | ||||||
| Total assets | $ | 19,823 | $ | 19,464 | ||||
| LIABILITIES AND STOCKHOLDERS' EQUITY | ||||||||
| Current liabilities: | ||||||||
| Accounts payable | $ | 2,719 | $ | 1,106 | ||||
| Accrued and other current liabilities | 1,732 | 1,394 | ||||||
| Total current liabilities | 4,451 | 2,500 | ||||||
| Lease liability | - | 1,233 | ||||||
| Other liabilities | 100 | - | ||||||
| Total liabilities | 4,551 | 3,733 | ||||||
| Stockholders' equity | 15,272 | 15,731 | ||||||
| Total liabilities and stockholders' equity | $ | 19,823 | $ | 19,464 |
Pharmaceuticals, Inc.