Cyclacel Pharmaceuticals, Inc. (NASDAQ: CYCC, NASDAQ: CYCCP;
"Cyclacel" or the "Company"), a biopharmaceutical company
developing innovative medicines based on cancer cell biology, today
reported financial results and business highlights for the first
quarter 2019. The Company's net loss applicable to common
shareholders for the three months ended March 31, 2019 was $1.9
million. As of March 31, 2019 cash and cash equivalents
totaled $17.9 million.
“We continue to execute on our strategy to develop innovative
therapies to overcome cancer resistance mechanisms through
combinations of our candidates with approved drugs,” said Spiro
Rombotis, President and Chief Executive Officer of Cyclacel. “Two
Phase 1, dose escalation studies evaluating CYC065 in combination
with venetoclax in patients with relapsed/refractory CLL and CYC140
as single agent in a first-in-human trial are open for accrual and
patients have been dosed on both studies. Two additional studies
evaluating combinations of CYC065 and sapacitabine with venetoclax
are under review by institutional review boards. The
Phase 1 study of single agent CYC065 has been amended to evaluate
an oral form of CYC065. We are pleased to report that the first two
patients with BRCA mutant breast cancer treated in the IST
evaluating sapacitabine and olaparib have achieved tumor shrinkage.
During the quarter, we also extended our projected cash runway to
the end of 2020 through our ATM equity sales agreement.”
Key Company Highlights
- Data was presented at the 2019 AACR Annual Meeting from the
Company's DNA damage response program with an oral, sequential
regimen of sapacitabine and seliciclib from an expansion cohort in
patients with BRCA mutant metastatic breast cancer. The data
demonstrated that the regimen was safe and led to a clinical
benefit rate of 30%. All eight PARP inhibitor naïve patients, half
of the patients previously treated with platinum agents and one on
previous PARP inhibitor responded. Progression on previous platinum
or PARP inhibitors was associated with lack of benefit. Both
sapacitabine and PARP inhibitors are more effective in cancer cells
with BRCA mutations or other homologous recombination repair
deficiencies.
- Based on data from the above study, the investigators are
enrolling a Phase 1b/2 study with an oral, concomitant regimen of
sapacitabine and olaparib in patients with BRCA mutant breast
cancer. According to the investigators three patients have been
dosed. The first two achieved tumor shrinkage and continue on
treatment and the third has completed first cycle without
dose-limiting toxicity. Dual targeting of the DNA damage response
pathway with sapacitabine and olaparib may improve the current
standard of care for such patients.
- Two patients have been treated in the Phase 1, dose escalation
clinical trial evaluating CYC065 in combination with venetoclax, a
Bcl-2 inhibitor, in patients with relapsed/refractory CLL.
Preclinical data presented at the 2018 AACR showed synergistic
activity of CYC065 and venetoclax combination in CLL tumor samples,
including those with 17p deletions. The combination was also active
in CLL samples resistant to either agent alone, suggesting that
dual targeting of Mcl-1 and Bcl-2 dependent mechanisms could
overcome intrinsic resistance to each individual compound.
- Two patients have been dosed in the recently opened Phase 1,
first-in-human, dose escalation study evaluating CYC140 monotherapy
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.
- The Company raised net proceeds of approximately $4.1 million
from its Common Stock Sales Agreement with H.C. Wainwright.
Key Upcoming Business Objectives
- Initiate CYC065-venetoclax Phase 1 study in patients with
relapsed or refractory AML or MDS;
- Initiate sapacitabine-venetoclax Phase 1 study in patients with
relapsed or refractory AML or MDS;
- Report initial data from the CYC065-venetoclax Phase 1 study in
relapsed/refractory leukemias;
- Report initial data from the CYC140 Phase 1 First-in-Human
study;
- Report initial data and bioavailability from the Phase 1 study
of an oral formulation of CYC065;
- Report updated CYC065 Phase 1 data in patients with advanced
solid cancers;
- Report data from the IST Phase 1b/2 trial of
sapacitabine-olaparib combination in patients with BRCA mutant
metastatic breast cancer when reported by the investigators;
- Determine regulatory pathway and submissibility of sapacitabine
in elderly AML patients.
Financial Highlights
As of March 31, 2019, cash and cash equivalents totaled $17.9
million compared to $17.5 million as of December 31, 2018. The
increase of $0.4 million in the three months was primarily due to
net proceeds from a Common Stock Sales Agreement with H.C.
Wainwright of $4.1m, offset by net cash used in operating
activities of $3.7 million. The Sales Agreement was concluded in
the first quarter 2019.
Research and development expenses were $1.0 million for the
three months ended March 31, 2019 compared to $0.8 million for the
same period in 2018.
General and administrative expenses were $1.2
million for the three months ended March 31, 2019 compared to $1.4
million for the same period in 2018.
Other income, net for the three months ended March 31, 2019 was
$0.1 million compared to $0.6 million for the same period of the
previous year.
The United Kingdom R&D and tax credit was $0.3 million for
the three months ended March 31, 2019 compared to $0.2 million for
the same period in 2018.
Net loss for the three months ended March 31, 2019 was $1.8
million compared to $1.3 million for the same period in 2018. With
the projected cash-sparing benefits accruing from the MD Anderson
alliance the Company believes that cash and marketable securities,
which were approximately $17.9 million as of March 31, 2019, will
be sufficient to finance operations through the end of 2020.
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 9383419
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 using its expertise in cell cycle, transcriptional
regulation and DNA damage response biology in cancer cells to
develop innovative medicines. The transcriptional regulation
program is evaluating CYC065, a CDK inhibitor, in patients with
advanced solid cancers and in combination with venetoclax in
patients with advanced hematological malignancies, including CLL
and AML. The DNA damage response program is evaluating a sequential
regimen of sapacitabine and seliciclib, a CDK inhibitor, in BRCA
positive patients with advanced solid cancers and a concomitant
regimen of sapacitabine and olaparib, a PARP inhibitor, in BRCA
positive patients with breast cancer. CYC140, a PLK inhibitor, is
in a Phase 1 first-in-human study in patients with advanced
leukemias. 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: |
Paul
McBarron, (908) 517-7330, pmcbarron@cyclacel.com |
Investor Relations: |
Russo Partners LLC, Alexander Fudukidis, (646)
942-5632, alex.fudukidis@russopartnersllc.com |
© Copyright 2019 Cyclacel Pharmaceuticals, Inc. All Rights
Reserved. The Cyclacel logo and Cyclacel® are trademarks of
Cyclacel Pharmaceuticals, Inc.
|
|
CYCLACEL PHARMACEUTICALS, INC. |
CONSOLIDATED STATEMENTS OF OPERATIONS |
(In $000s, except share and per share amounts) |
(Unaudited) |
|
|
|
|
|
Three Months Ended |
|
|
|
|
March 31, |
|
|
|
|
2018 |
|
2019 |
|
|
|
|
|
|
|
|
|
|
|
Revenues: |
|
|
|
|
|
|
|
|
Total
revenues |
|
|
- |
|
|
|
- |
|
Operating
expenses: |
|
|
|
|
|
|
|
|
|
Research and
development |
|
|
798 |
|
|
|
1,012 |
|
|
General and
administrative |
|
|
1,364 |
|
|
|
1,192 |
|
Total
operating expenses |
|
|
2,162 |
|
|
|
2,204 |
|
Operating
loss |
|
|
(2,162 |
) |
|
|
(2,204 |
) |
Other income
(expense): |
|
|
|
|
|
|
|
|
|
Foreign exchange
gains (losses) |
|
|
(4 |
) |
|
|
15 |
|
|
Interest
income |
|
|
69 |
|
|
|
79 |
|
|
Other income,
net |
|
|
566 |
|
|
|
- |
|
|
|
Total other income (expense),
net |
|
|
631 |
|
|
|
94 |
|
Loss from
continuing operations before taxes |
|
|
(1,531 |
) |
|
|
(2,110 |
) |
Income tax
benefit |
|
|
182 |
|
|
|
268 |
|
Net loss
from continuing operations |
|
|
(1,349 |
) |
|
|
(1,842 |
) |
Net
loss |
|
|
(1,349 |
) |
|
|
(1,842 |
) |
Dividend on
convertible exchangeable preferred shares |
|
|
(50 |
) |
|
|
(50 |
) |
Net loss
applicable to common shareholders |
|
$ |
(1,399 |
) |
|
$ |
(1,892 |
) |
Basic and
diluted earnings per common share: |
|
|
|
|
|
|
|
|
Net loss per share
– basic and diluted |
|
$ |
(0.12 |
) |
|
$ |
(0.14 |
) |
Weighted average
common shares outstanding |
|
|
11,997,447 |
|
|
|
13,638,271 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
CYCLACEL PHARMACEUTICALS, INC. |
CONSOLIDATED BALANCE SHEET |
(In $000s, except share, per share, and liquidation
preference amounts) |
(Unaudited) |
|
|
|
|
|
December 31, |
|
March 31, |
|
|
|
|
2018 |
|
2019 |
|
|
|
|
|
|
|
ASSETS |
|
|
|
|
Current
assets: |
|
|
|
|
|
Cash and cash
equivalents |
|
$ |
17,504 |
|
$ |
17,934 |
|
Prepaid expenses
and other current assets |
|
|
2,283 |
|
|
2,190 |
|
|
Total current assets |
|
|
19,787 |
|
|
20,124 |
|
|
|
|
|
|
|
|
Property and
equipment, net |
|
|
36 |
|
|
33 |
|
Right-of-use lease
asset |
|
|
- |
|
|
1,353 |
|
|
Total assets |
|
$ |
19,823 |
|
$ |
21,510 |
LIABILITIES AND STOCKHOLDERS’
EQUITY |
|
|
|
|
Current
liabilities: |
|
|
|
|
|
Accounts
payable |
|
$ |
2,719 |
|
$ |
1,284 |
|
Accrued and other
current liabilities |
|
|
1,732 |
|
|
1,203 |
|
|
Total current liabilities |
|
|
4,451 |
|
|
2,487 |
Lease
liability |
|
|
- |
|
|
1,468 |
Other
liabilities |
|
|
100 |
|
|
- |
|
|
Total liabilities |
|
|
4,551 |
|
|
3,955 |
Stockholders’ equity |
|
|
15,272 |
|
|
17,555 |
|
|
Total liabilities and
stockholders’ equity |
|
$ |
19,823 |
|
$ |
21,510 |
|
|
|
|
|
|
|
SOURCE: Cyclacel Pharmaceuticals, Inc.
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