Full Press Release Details
Pharmaceuticals Reports SECOND Quarter 2020 Financial Results
Call Scheduled August 12, 2020 at 4:30 p.m. ET -
Berkeley Heights, NJ, August 12,
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 second quarter
2020 and business highlights, including an update on its progress with fadraciclib, Cyclacel's novel CDK2/9 inhibitor.
The Company's net loss applicable to
common shareholders for the three months ended June 30, 2020 was $2.2 million. As of June 30, 2020, cash and cash equivalents totaled
$25.3 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 believe fadraciclib is establishing
a leadership position among MCL1 suppressing compounds in development. Our recent, peer-reviewed publication elaborates the
mechanistic rationale for fadraciclib as an anti-cancer therapy signifying the benefits of inhibiting CDK2 and CDK9, two complementary
cancer pathways," said Spiro Rombotis, President and Chief Executive Officer. "We continue to be encouraged
by observations of deep partial response and prolonged stable disease with tumor shrinkage as an intravenously administered monotherapy
in patients with advanced solid tumors and antileukemic activity in combination with venetoclax. In
parallel with evaluating fadraciclib in certain leukemias, we are executing a precision medicine strategy to evaluate the compound
in patients with solid tumors with study enrollment expected to begin by the first quarter of 2021. As the global pandemic
continues to unfold, our priorities are to ensure patient and employee safety and support efforts to stem COVID-19 disease as part
of our corporate social responsibility. Despite the challenges we remain committed to our strategy of building an innovative pipeline
addressing the rising problem of cancer resistance and achieving our clinical milestones to drive shareholder value."
Key Corporate Highlights
More information on our clinical trials can be found here.
Key Business Objectives
Financial Highlights
As of June 30, 2020, cash and cash
equivalents totaled $25.3 million, compared to $11.9 million as of December 31, 2019. The increase of $13.4 million was primarily
due to net proceeds of $18.3 million from an equity financing in April 2020 and net cash used in operating activities of $4.7 million.
There were no revenues for each of the three months ended June 30, 2020 and 2019.
Research and development expenses were $1.2 million for each
of the three months ended June 30, 2020 and 2019. Research and development expenses relating to transcriptional regulation increased
by approximately $0.2 million for the three months ended June 30, 2020 as we continue to progress the clinical evaluation
General and administrative expenses
for the three months ended June 30, 2020 were $1.3 million, compared to $1.2 million for the same period of the previous year.
Total other income, net, for the three
months ended June 30, 2020 was $20,000, compared to $0.2 million for the same period of the previous year. The decrease of approximately
$0.2 million for the three months ended June 30, 2020 is primarily related to income received under an Asset Purchase Agreement
with Thermo Fisher Scientific Inc.
United Kingdom research & development
tax credits were $0.3 million for each of the three months ended June 30, 2020 and 2019.
Net loss for the three months ended
June 30, 2020 was $2.2 million compared to $1.8 million for the same period in 2019.
The Company estimates
that cash resources of $25.3 million as of June 30, 2020 will fund currently planned programs
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 2477369.
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 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. The anti-mitotic program
is evaluating CYC140, a PLK1 inhibitor, in advanced leukemias/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
Forward-looking Statements
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, Jan Medina, (646) 942-5632, Jan.Medina@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 | ||||||||
| June 30, | ||||||||
| 2019 | 2020 | |||||||
| Revenues: | ||||||||
| Total revenues | - | - | ||||||
| Operating expenses: | ||||||||
| Research and development | 1,153 | 1,163 | ||||||
| General and administrative | 1,184 | 1,309 | ||||||
| Total operating expenses | 2,337 | 2,472 | ||||||
| Operating loss | (2,337 | ) | (2,472 | ) | ||||
| Other income (expense): | ||||||||
| Foreign exchange gains (losses) | 21 | (2 | ) | |||||
| Interest income | 56 | 4 | ||||||
| Other income, net | 170 | 18 | ||||||
| Total other income (expense), net | 247 | 20 | ||||||
| Loss before taxes | (2,090 | ) | (2,452 | ) | ||||
| Income tax benefit | 307 | 286 | ||||||
| Net loss | (1,783 | ) | (2,166 | ) | ||||
| Dividend on convertible exchangeable preferred shares | (50 | ) | (50 | ) | ||||
| Net loss applicable to common shareholders | $ | (1,833 | ) | $ | (2,216 | ) | ||
| Basic and diluted earnings per common share: | ||||||||
| Net loss per share - basic and diluted | $ | (2.13 | ) | $ | (0.58 | ) | ||
| Weighted average common shares outstanding | 859,998 | 3,850,228 |
CYCLACEL PHARMACEUTICALS, INC.
CONSOLIDATED BALANCE SHEET
(In $000s, except share, per share, and
liquidation preference amounts)
| December 31, | June 30, | |||||||
| 2019 | 2020 | |||||||
| ASSETS | ||||||||
| Current assets: | ||||||||
| Cash and cash equivalents | $ | 11,885 | $ | 25,342 | ||||
| Prepaid expenses and other current assets | 2,132 | 2,591 | ||||||
| Total current assets | 14,017 | 27,933 | ||||||
| Property and equipment, net | 27 | 20 | ||||||
| Right-of-use lease asset | 1,264 | 1,218 | ||||||
| Total assets | $ | 15,308 | $ | 29,171 | ||||
| LIABILITIES AND STOCKHOLDERS' EQUITY | ||||||||
| Current liabilities: | ||||||||
| Accounts payable | $ | 890 | $ | 342 | ||||
| Accrued and other current liabilities | 1,530 | 1,170 | ||||||
| Total current liabilities | 2,420 | 1,512 | ||||||
| Lease liability | 1,191 | 1,081 | ||||||
| Other liabilities | - | - | ||||||
| Total liabilities | 3,611 | 2,593 | ||||||
| Stockholders' equity | 11,697 | 26,578 | ||||||
| Total liabilities and stockholders' equity | $ | 15,308 | $ | 29,171 |
SOURCE: Cyclacel Pharmaceuticals, Inc.