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
- Appointed Mark Kirschbaum, M.D. as Senior Vice
President and Chief Medical Officer. Dr. Kirschbaum is a
highly experienced hematologist/oncologist with over 30 years of
experience in molecular medicine, new drug development, clinical
trial design and patient care. He has management experience in
academic research, clinical practice and pharmaceutical industry
settings. As CMO, he is responsible for advancing Cyclacel’s
pipeline and is leading clinical strategy, patient safety and
medical affairs.
- Fadraciclib Oral
Presentation at the Plenary Session
of the 32nd EORTC-NCI-AACR
(ENA) Symposium 2020
• In part 2 of a Phase 1, dose
escalation study, fadraciclib was administered intravenously as
monotherapy to 24 heavily pretreated patients with various advanced
solid tumors.
• Out of 11 patients treated at the
fourth dose level one achieved confirmed partial response (PR) and
two stable disease (SD).
• The PR was observed after a month
and a half on fadraciclib in a patient with MCL1-amplified
endometrial cancer who had failed seven lines of prior therapy. The
patient remains on treatment after 16 months with 92% reduction in
target tumor lesions.
• SD was observed in a patient with
cyclin E amplified ovarian cancer who achieved 29% shrinkage in
target tumor lesions after four months and a patient with fallopian
tube adenocarcinoma with undetermined protein level.
• In three patients treated in part 3
with oral fadraciclib high oral bioavailability and overlapping
pharmacokinetics were observed compared to the intravenously
administered, identical schedule in part 2.
- CYC065-02 Phase 1 fadraciclib i.v. and venetoclax
p.o. in CLL - five
patients with R/R CLL have been treated in four dose levels up to
150 mg/m2 of fadraciclib in combination with venetoclax.
Fadraciclib is administered after completion of venetoclax ramp.
Antileukemic activity was observed in three patients who achieved
MRD negativity on the combination, one in bone marrow and two in
bone marrow and peripheral blood. The latter two patients have also
demonstrated continued shrinkage of lymph nodes on the combination.
In one patient all target lesions and in the other 2 out of 4
lesions have shrunk below 1.5 cm. Both are waiting for confirmation
of response. Preclinical data support a dual targeting strategy of
both BCL2 and MCL1 in CLL.
- CYC065-03 Phase
1 fadraciclib i.v.
and venetoclax
p.o. in
AML/MDS - fourteen heavily
pretreated patients with relapsed/refractory (R/R) AML were treated
in five dose levels up to 200 mg/m2 of fadraciclib in combination
with venetoclax. Antileukemic activity has been observed in four
out of twelve patients available for assessment. Preclinical data
in AML suggest that targeting both MCL1 and BCL2 may be more
beneficial than inhibiting either protein alone.
- CYC140-01 Phase 1 CYC140 i.v. - We have
enrolled 7 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. In parallel with
hematological malignancies, we are planning studies of CYC140 in
solid tumors.
- CYC682-11 Phase 1
part 2 sapacitabine p.o. and venetoclax
p.o. - twelve patients have been enrolled
in a dose escalation study in our DNA Damage Response (DDR) program
evaluating an oral combination of sapacitabine and venetoclax in
patients with R/R AML/MDS. Two patients, previously treated with
combination therapies including hypomethylating agents, have
achieved 5 and 6 cycles of treatment respectively. 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 a BCL2 inhibitor,
which may offer an effective, oral treatment regimen for patients
who have failed front-line therapy.
- Appointed Karin L.
Walker to the Board of Directors. Ms. Walker brings
over 30 years of extensive finance experience in
biopharmaceuticals, including in public biotechnology companies,
and technology companies. Ms. Walker currently serves as the Chief
Accounting Officer of Prothena Corporation plc, a late-stage
clinical company with expertise in protein dysregulation and a
pipeline of novel investigational therapeutics focused on
neurodegenerative and rare peripheral amyloid diseases, and has
held this position since 2013.
More information on our clinical trials can be found here.
Key Business Objectives
- Treat first patient with orally-administered fadraciclib in
Phase 1/2 advanced solid tumors study;
- Report initial data from fadraciclib-venetoclax Phase 1 study
in R/R AML/MDS & CLL;
- Report safety and PK data from Phase 1 study of fadraciclib
oral formulation;
- Report initial data from CYC140 Phase 1 first-in-human study in
R/R leukemias; and
- Report initial data from sapacitabine-venetoclax Phase 1 study
in R/R AML/MDS;
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 income.
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)
537-3406
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, 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
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.
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Contacts |
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Company: |
Paul McBarron, (908) 517-7330, pmcbarron@cyclacel.com |
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Investor Relations: |
Russo Partners LLC, Eric Ando, (646) 218-4604,
eric.ando@russopartnersllc.com |
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© 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.
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