Full Press Release Details
Pharmaceuticals Reports THIRD Quarter 2020 Financial Results
Call Scheduled November 11, 2020 at 4:30 p.m. ET -
Berkeley Heights, NJ, November 11,
2020 - Cyclacel Pharmaceuticals, Inc. (NASDAQ: CYCC, NASDAQ: CYCCP; "Cyclacel" or the "Company"), a biopharmaceutical
company developing innovative medicines based on cancer cell biology, today reported its financial results for the third quarter
2020 and certain business highlights.
The Company's net loss applicable to
common shareholders for the three months ended September 30, 2020 was $2.3 million. As of September 30, 2020, cash and cash equivalents
totaled $23.1 million. Based on current spending, the Company estimates it has sufficient resources to fund planned operations,
including research and development, through the end of 2022.
"We continue to execute on our
clinical development plan for fadraciclib and CYC140 in both liquid and solid cancers," said Spiro Rombotis, President and
Chief Executive Officer. "The recent ENA presentation highlighted fadraciclib's oral bioavailability and deepening
confirmed response as a single agent. Recent publications elaborated the
mechanistic rationale for fadraciclib highlighting dual inhibition of CDK2 and CDK9 cancer pathways. We are encouraged by evidence
of antileukemic activity in our studies of fadraciclib in combination with venetoclax in
hematological malignancies, including CLL. Dr. Mark Kirschbaum, our newly appointed CMO, is reviewing our programs and streamlining
our clinical work flows to progress our clinical strategy and improve efficiency. We
are looking forward to reporting data from ongoing studies and outlining our clinical development plans for fadraciclib and CYC140
to drive shareholder value."
Key Corporate 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
More information on our clinical trials can be found here.
Key Business Objectives
Financial Highlights
As of September 30, 2020, cash and
cash equivalents totaled $23.1 million, compared to $11.9 million as of December 31, 2019. The increase of $11.2 million was primarily
due to net proceeds of $18.3 million from an equity financing in April 2020, offset by net cash used in operating activities of
$6.8 million. There were no revenues for each of the three months ended September 30, 2020 and 2019.
Research and development expenses were $1.1 million for each
of the three months ended September 30, 2020 and 2019. Research and development expenses relating to transcriptional regulation
increased by approximately $0.1 million for the three months ended September 30, 2020 as we continue to progress the clinical
evaluation of fadraciclib.
General and administrative expenses
for the three months ended September 30, 2020 were $1.5 million, compared to $1.3 million for the same period of the previous year.
The increase of $0.2 million for the three months ended September 30, 2020 is due to increased professional costs.
Total other income, net, for the three
months ended September 30, 2020 was $35,000, compared to $174,000 for the same period of the previous year. The decrease of approximately
$140,000 for the three months ended September 30, 2020 is primarily related to reductions in foreign exchange gains and interest
United Kingdom research & development
tax credits were $0.3 million for each of the three months ended September 30, 2020 and 2019.
Net loss for the three months ended
September 30, 2020 was $2.3 million compared to $1.9 million for the same period in 2019.
The Company estimates
that cash resources of $23.1 million as of September 30, 2020 will fund currently planned programs
through the end of 2022.
Conference call information:
US/Canada call: (877) 493-9121 / international call: (973) 582-2750
US/Canada archive: (800) 585-8367 / international archive: (404)
Code for live and archived conference call is 4884678.
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 fadraciclib as a single agent in solid tumors and in combination with venetoclax
in patients with relapsed or refractory AML/MDS and CLL. The anti-mitotic program is evaluating CYC140, a PLK1 inhibitor, in advanced
leukemias/MDS patients. The DNA damage response program is evaluating an oral combination of sapacitabine and venetoclax in patients
with relapsed or refractory AML/MDS. An investigator-sponsored trial (IST) is evaluating an oral combination of sapacitabine and
olaparib in patients with BRCA mutant breast cancer. 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.
Paul McBarron, (908) 517-7330, pmcbarron@cyclacel.com
Investor Relations: Russo
Partners LLC, Eric Ando, (646) 218-4604, eric.ando@russopartnersllc.com
Copyright 2020 Cyclacel Pharmaceuticals, Inc. All Rights
Reserved. The Cyclacel logo and Cyclacel are trademarks of Cyclacel Pharmaceuticals, Inc.
CYCLACEL PHARMACEUTICALS, INC.
CONSOLIDATED STATEMENTS OF OPERATIONS (LOSS)
(In $000s, except share and per share amounts)
| Three Months Ended September 30, | ||||||||
| 2019 | 2020 | |||||||
| Revenues: | ||||||||
| Total revenues | - | - | ||||||
| Operating expenses: | ||||||||
| Research and development | 1,063 | 1,075 | ||||||
| General and administrative | 1,285 | 1,497 | ||||||
| Total operating expenses | 2,348 | 2,572 | ||||||
| Operating loss | (2,348 | ) | (2,572 | ) | ||||
| Other income (expense): | ||||||||
| Foreign exchange gains (losses) | 79 | (25 | ) | |||||
| Interest income | 42 | 4 | ||||||
| Other income, net | 53 | 56 | ||||||
| Total other income (expense), net | 174 | 35 | ||||||
| Loss before taxes | (2,174 | ) | (2,537 | ) | ||||
| Income tax benefit | 273 | 281 | ||||||
| Net loss | (1,901 | ) | (2,256 | ) | ||||
| Dividend on convertible exchangeable preferred shares | (50 | ) | (50 | ) | ||||
| Net loss applicable to common shareholders | $ | (1,951 | ) | $ | (2,306 | ) | ||
| Basic and diluted earnings per common share: | ||||||||
| Net loss per share - basic and diluted | $ | (2.27 | ) | $ | (0.47 | ) | ||
| Weighted average common shares outstanding | 859,998 | 4,863,984 |
CYCLACEL PHARMACEUTICALS, INC.
CONSOLIDATED BALANCE SHEET
(In $000s, except share, per share, and
liquidation preference amounts)
| December 31, | September 30, | |||||||
| 2019 | 2020 | |||||||
| ASSETS | ||||||||
| Current assets: | ||||||||
| Cash and cash equivalents | $ | 11,885 | $ | 23,130 | ||||
| Prepaid expenses and other current assets | 2,132 | 2,804 | ||||||
| Total current assets | 14,017 | 25,934 | ||||||
| Property and equipment, net | 27 | 64 | ||||||
| Right-of-use lease asset | 1,264 | 1,215 | ||||||
| Total assets | $ | 15,308 | $ | 27,213 | ||||
| LIABILITIES AND STOCKHOLDERS' EQUITY | ||||||||
| Current liabilities: | ||||||||
| Accounts payable | $ | 890 | $ | 455 | ||||
| Accrued and other current liabilities | 1,530 | 1,257 | ||||||
| Total current liabilities | 2,420 | 1,712 | ||||||
| Lease liability | 1,191 | 1,063 | ||||||
| Total liabilities | 3,611 | 2,775 | ||||||
| Stockholders' equity | 11,697 | 24,438 | ||||||
| Total liabilities and stockholders' equity | $ | 15,308 | $ | 27,213 |
SOURCE: Cyclacel Pharmaceuticals, Inc.