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
- CYC065-01 Phase 1 part 2 single
agent i.v. – In November 2019, we
reported anticancer activity in a heavily pretreated a patient with
MCL1 amplified endometrial cancer who achieved a radiographically
confirmed partial response (PR) after 4 cycles at 213mg. The
patient remains on study after 10 cycles and shrinkage of her
target tumor lesions has reached 73%. An additional patient with
cyclin E amplified ovarian cancer achieved stable disease after 4
cycles at 213mg with 29% tumor shrinkage. We are expanding the
213mg dose level to recruit additional patients and determine the
recommended Phase 2 dose.
- CYC065-01 Phase 1 part 3 single
agent p.o. – We are evaluating an oral
capsule form of fadraciclib in patients with advanced solid tumors
and have enrolled two patients at 75mg and 150mg once daily.
Pharmacokinetic (PK) data in the two patients demonstrated a
predictable PK profile closely overlapping the i.v. form with
encouraging exposure levels.
- CYC065-03 Phase 1 fadraciclib i.v. and venetoclax
p.o. – We have dosed 11 heavily pretreated patients with
R/R AML in five dose levels up to 200 mg/m2 in combination with the
BCL2 inhibitor venetoclax. Evidence of anticancer activity has been
observed in multiple patients with blast reductions in peripheral
blood. Preclinical AML data demonstrated synergy of fadraciclib and
venetoclax, suggesting that targeting both BCL2 and MCL1 may be
more beneficial than inhibiting either protein alone.
- CYC065-02 Phase 1 fadraciclib i.v. and venetoclax
p.o. – We have dosed 3 patients with R/R CLL in two dose
levels up to 85 mg/m2 in combination with venetoclax. Evidence of
anticancer activity has been observed in two patients who
experienced reduction in lymph node size with one of them achieving
MRD negative status. Preclinical CLL data demonstrated synergy of
fadraciclib and venetoclax, suggesting that targeting both BCL2 and
MCL1 may be more beneficial than inhibiting either protein alone.
- CYC682-11 Phase 1b/2 part 2 sapacitabine p.o.
and venetoclax p.o.– We have enrolled 10 patients
in two dose cohorts in our DNA Damage Response (DDR) program
evaluating an oral combination of sapacitabine and venetoclax in
patients with R/R AML/MDS. Sapacitabine is a nucleoside analogue
that is active in AML and MDS R/R to prior therapy such as
cytarabine or hypomethylating agents. Preclinical data demonstrated
synergy of sapacitabine with BCL2 inhibition which may offer an
effective, oral treatment regimen for patients who have failed
front-line therapy.
- CYC140-01 Phase 1 CYC140 i.v. - We have
enrolled 4 patients in our first-in-human, dose escalation study
evaluating CYC140 in patients with advanced leukemias. CYC140 is a
small molecule, selective polo-like-kinase 1 (PLK1) inhibitor that
has demonstrated potent and selective target inhibition and high
activity in xenograft models of human cancers.
More information on our clinical trials can be found at
www.clinicaltrials.gov.
Key Business Objectives for 2020
- Report updated Phase 1 safety, PK and efficacy data for
fadraciclib utilizing a frequent i.v. dosing schedule in patients
with advanced solid cancers;
- Report initial safety and PK data from the Phase 1 study of an
oral formulation of fadraciclib;
- Report initial safety and proof of concept data from the
fadraciclib-venetoclax Phase 1 studies in R/R AML/MDS and CLL;
- Report initial data from the sapacitabine-venetoclax Phase 1b/2
study in patients with R/R AML/MDS;
- Report initial data from the CYC140 Phase 1 first-in-human
study in R/R leukemias; and
- Report data from the Phase 1b/2 IST of sapacitabine-olaparib
combination in patients with BRCA mutant metastatic breast cancer
when reported by the investigators.
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) 582-2750US/Canada
archive: (800) 585-8367 / international archive: (404) 537-3406
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 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.
Contacts |
|
|
Company:Investor Relations: |
|
Paul McBarron, (908) 517-7330, pmcbarron@cyclacel.comRusso
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 |
|
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(In $000s,
except share, per share, and liquidation preference amounts)
|
December 31, |
|
December 31, |
|
2018 |
|
2019 |
|
|
|
|
ASSETS |
|
|
|
Current
assets: |
|
|
|
Cash and cash equivalents |
$ |
17,504 |
|
$ |
11,885 |
Prepaid expenses and other current assets |
|
2,283 |
|
|
2,132 |
Total current assets |
|
19,787 |
|
|
14,017 |
|
|
|
|
Property and equipment, net |
|
36 |
|
|
27 |
Right-of-use lease asset |
|
- |
|
|
1,264 |
Total assets |
$ |
19,823 |
|
$ |
15,308 |
|
|
|
|
LIABILITIES AND STOCKHOLDERS’ EQUITY |
|
|
|
Current
liabilities: |
|
|
|
Accounts payable |
$ |
2,719 |
|
$ |
890 |
Accrued and other current liabilities |
|
1,732 |
|
|
1,530 |
Total current liabilities |
|
4,451 |
|
|
2,420 |
Lease
liability |
|
- |
|
|
1,191 |
Other
liabilities |
|
100 |
|
|
- |
Total liabilities |
|
4,551 |
|
|
3,611 |
Stockholders’ equity |
|
15,272 |
|
|
11,697 |
Total liabilities and stockholders’ equity |
$ |
19,823 |
|
$ |
15,308 |
|
|
|
|
SOURCE: Cyclacel Pharmaceuticals, Inc.
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