Full Press Release Details
Pharmaceuticals Reports Fourth Quarter and Full Year 2019 Financial Results
- Anticancer Activity of Fadraciclib
(CYC065) Monotherapy in Patients with MCL1 Amplified Solid Tumor
and Fadraciclib-venetoclax Combination
in Patients with Relapsed or Refractory AML/MDS and CLL -
Conference Call Scheduled February 26, 2020 at 4:30 p.m. EDT -
Berkeley Heights, NJ, February 26,
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 and business highlights
for the fourth quarter and full year ended December 31, 2019. The Company's net loss applicable to common shareholders for the
three months and year ended December 31, 2019 was $2.4 million and $8.0 million, respectively. As of December 31, 2019, cash and
cash equivalents totaled $11.9 million. Based on current spending, cash on hand provides the Company with sufficient resources
to fund all planned operations including research and development through Q1 2021.
"Our fadraciclib (CYC065) CDK inhibitor is establishing
a leadership position among MCL1 suppressing compounds in clinical development," said Spiro Rombotis, President and Chief
Executive Officer. "After enrolling approximately 60 patients to date with multiple dosing schedules in three Phase 1 dose
escalation studies in patients with relapsed or refractory (R/R) solid tumors and hematological malignancies, we have demonstrated
safety, proof of mechanism by durable suppression of MCL1 and anticancer activity of fadraciclib as single agent and in combinations.
Encouragingly, a heavily pretreated patient with MCL1 amplified endometrial cancer has received over 10 cycles of fadraciclib monotherapy
achieved a confirmed partial response (PR) and a further reduction in her target tumor lesions of 73%. Based on data thus far,
we are developing a precision medicine strategy to further evaluate fadraciclib as monotherapy and in combinations. In our Phase
1 trial of a combination of fadraciclib and venetoclax in patients with relapsed or refractory AML/MDS, we have enrolled 11 patients
and reached dose level five and in CLL 3 patients and dose level two. Our clinical stage pipeline, comprising of fadraciclib, sapacitabine
and CYC140, our PLK1 inhibitor, is a central element of our strategy of building an innovative pipeline addressing cancer resistance
and DNA damage response."
Key Corporate Highlights
on our clinical trials can be found at www.clinicaltrials.gov.
Key Business Objectives for 2020
Financial Highlights
As of December 31, 2019, cash and cash
equivalents totaled $11.9 million, compared to $17.5 million as of December 31, 2018. The decrease of $5.6 million was primarily
due to net cash used in operating activities of $9.4 million, offset by $3.8 million of net cash provided by financing activities.
Revenues for the three months and year
ended December 31, 2019 amounted to $0 compared to $0.2 million for the same periods in 2018. The 2018 revenue related to a collaboration,
licensing and supply agreement with ManRos Therapeutics, entered into in June 2015.
Research and development expenses were
$1.4 million and $4.7 million for the three months and year ended December 31, 2019 as compared to $1.1 million and $4.3 million
for the same periods in 2018. Research and development expenses relating to the transcriptional regulation, CDK inhibitor program
with fadraciclib increased by $0.5 million from $2.5 million for the year ended December 31, 2018 to $3.0 million for the year
ended December 31, 2019, as the clinical evaluation of fadraciclib progressed. Research and development expenses relating to the
DDR, sapacitabine program decreased by $0.4 million from $0.9 million for the year ended December 31, 2018 to $0.5 million for
the year ended December 31, 2019, primarily as a result of expenditure related to clinical trial drug supply manufacturing in 2018.
General and administrative expenses
for the three months and year ended December 31, 2019 were $1.4 million and $5.0 million respectively, compared to $1.5 million
and $5.4 million for the same periods of the previous year.
Total other income, net for the three
months and year ended December 31, 2019 were $0.1 million and $0.6 million, compared to $0.1 million and $0.9 million for the same
periods of the previous year. The decrease of $0.3 million for the year ended December 31, 2019 is primarily related to a reduction
in income received under an Asset Purchase Agreement with ThermoFisher Scientific.
United Kingdom research & development
tax credits were $0.4 million and $1.3 million for the three months and year ended December 31, 2019 as compared to $0.4 million
and $1.3 million for the same periods in 2018.
Net loss for the three months and year
ended December 31, 2019 were $2.3 million and $7.8 million compared to $2.0 million and $7.3 million for the same periods in 2018.
The Company raised net proceeds of
approximately $4.1 million during 2019, from its Common Stock Sales Agreement with H.C. Wainwright,
which is now completed.
The Company estimates
that cash resources of $11.9 million as of December 31, 2019 will fund currently planned programs
through the first quarter of 2021.
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 6761906.
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, Inc.
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 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
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.
CYCLACEL PHARMACEUTICALS, INC.
CONSOLIDATED STATEMENTS OF OPERATIONS (LOSS)
share and per share amounts)
| Three Months Ended | ||||||||
| December 31, | ||||||||
| 2018 | 2019 | |||||||
| Revenues: | ||||||||
| Total revenues | 150 | - | ||||||
| Operating expenses: | ||||||||
| Research and development | 1,142 | 1,430 | ||||||
| General and administrative | 1,474 | 1,363 | ||||||
| Total operating expenses | 2,616 | 2,793 | ||||||
| Operating loss | (2,466 | ) | (2,793 | ) | ||||
| Other income (expense): | ||||||||
| Foreign exchange gains (losses) | (48 | ) | (14 | ) | ||||
| Interest income | 93 | 47 | ||||||
| Other income, net | 50 | 8 | ||||||
| Total other income (expense), net | 95 | 41 | ||||||
| Loss before taxes | (2,371 | ) | (2,752 | ) | ||||
| Income tax benefit | 353 | 449 | ||||||
| Net loss | (2,018 | ) | (2,303 | ) | ||||
| Dividend on convertible exchangeable preferred shares | (50 | ) | (51 | ) | ||||
| Net loss applicable to common shareholders | $ | (2,068 | ) | $ | (2,354 | ) | ||
| Basic and diluted earnings per common share: | ||||||||
| Net loss per share - basic and diluted | $ | (0.17 | ) | $ | (0.14 | ) | ||
| Weighted average common shares outstanding | 12,381,031 | 17,199,974 |
CYCLACEL PHARMACEUTICALS, INC.
CONSOLIDATED BALANCE SHEET