Cyclacel Pharmaceuticals, Inc. (NASDAQ:CYCC) (NASDAQ:CYCCP)
("Cyclacel" or the "Company") a biopharmaceutical company
developing oral therapies that target the various phases of cell
cycle control for the treatment of cancer and other serious
disorders, today reported its financial results and business
highlights for the first quarter ended March 31, 2017.
The Company's net loss applicable to common
shareholders for the three months ended March 31, 2017 was $1.6
million or $0.38 per share, compared to net loss applicable to
common shareholders of $3.1 million, or $1.04 per share for the
first quarter of 2016. As of March 31, 2017, cash and cash
equivalents totaled $12.7 million.
"Our development priorities going forward are our
transcriptional regulation and DNA damage response clinical stage
programs," said Spiro Rombotis, President and Chief Executive
Officer of Cyclacel. "In the Phase 1 study of our CYC065 CDK
inhibitor in patients with solid tumors, we are close to
establishing the recommended Phase 2 dose. Biomarker analysis
shows evidence of target engagement and preliminary clinical
activity. In parallel, we are reviewing with investigators study
designs to test CYC065 in combination with approved agents in
hematological indications. We are expanding our BRCA positive,
sapacitabine and CDK inhibitor study to evaluate patients with
ovarian and pancreatic cancers in addition to breast. We look
forward to reporting our progress with these programs and the
outcome of our final analysis of SEAMLESS data."
Quarter and Recent Highlights
Transcriptional regulation
program: cyclin dependent kinase (CDK)
inhibitor
- In the ongoing Phase 1, first-in-human trial of CYC065, a
CDK2/9 inhibitor, in heavily pretreated patients with advanced
solid tumors we are expanding the sixth dose escalation level to a
total of 9 patients with the objective of determining the
recommended Phase 2 dose. Following analysis of biomarkers from
patient specimens obtained at baseline and during CYC065 treatment,
evidence of pharmacodynamic engagement has been observed, including
reduction in Mcl-1 expression. Preliminary evidence of clinical
activity has been observed in two patients with MYC and CCNE
(cyclin E) amplifications. These observations are consistent
with the Company’s preclinical data and the drug’s mechanism of
action.
- At the American Association for Cancer Research 2017 Annual
Meeting, independent researchers from The University of Texas MD
Anderson Cancer Center presented preclinical data demonstrating
therapeutic potential of CYC065, as a targeted anti-cancer agent.
The poster titled “The next generation CDK2/9 inhibitor CYC065
elicits marked antineoplastic effects in lung cancer by engaging
anti-metastatic pathways” detailed data which show CYC065's
potential to cause anaphase catastrophe and inhibit migration and
invasion of lung cancer cells including mutant KRAS, a key
molecular features of such cancers.
- Preclinical data published in the Journal of National Cancer
Institute demonstrated that CYC065 had prominent antitumor activity
against lung cancer through anaphase catastrophe, a novel,
mitosis-specific mechanism of action.
DNA damage response program
- The Phase 1 combination of sapacitabine and seliciclib CDK
inhibitor is continuing enrollment in an extension study in an
enriched population of approximately 20 patients with BRCA positive
advanced breast cancer.
- A part 3 of this study has been designed with the goal of
testing a revised dosing schedule in additional patients, including
BRCA mutation positive, ovarian and pancreatic cancer
patients.
SEAMLESS study in acute myeloid leukemia
(AML)
- In February 2017, the Company reported that the study did not
reach statistically significant superiority in overall survival
(OS), although an improvement in complete remission rate was
observed. In the stratified subgroup of patients with low baseline
peripheral white blood cell count, comprising approximately
two-thirds of the study's population, an improvement in OS was
observed for the experimental arm.
- The Company is currently analyzing stratified and exploratory
subgroups to identify patients who are most likely to benefit from
treatment with the experimental arm. Depending on this analysis the
Company may initiate discussions with European and U.S. regulators
to determine a potential regulatory pathway.
PLK inhibitor CYC140
During the quarter, Cyclacel announced a poster presentation at
the American Association for Cancer Research (AACR) 2017 Annual
Meeting. The poster, titled “The novel PLK1 inhibitor, CYC140:
Identification of pharmacodynamic markers, sensitive target
indications and potential combinations” detailed Cyclacel’s
preclinical study to identify sensitive target indications
including acute leukemia and esophageal cancer. The data
demonstrated antitumor activity of CYC140 in preclinical xenograft
models of acute leukemia and solid tumors, including esophageal
cancer, with tumor growth delay, tumor regression and cures being
observed. In addition several pharmacodynamic markers were
identified and activity was demonstrated in a majority of malignant
cell lines derived from AML, acute lymphoblastic leukemia (ALL) and
esophageal cancer.
Financial highlights
As of March 31, 2017, cash and cash equivalents totaled $12.7
million, compared to $16.5 million as of December 31, 2016. The
decrease of $3.8 million was due to net cash used in operating
activities. Net proceeds of approximately $1.0 million were
received in April 2017 from the sale of common stock through the
Company’s at the market facility.
There were no revenues for the three months ended March 2017
compared to $0.1 million for the same period of the previous year.
The revenue is related to previously awarded, UK government grants
being recognized over the period to progress IND-directed
preclinical development of CYC140, a novel, PLK-1 inhibitor, which
was completed in November 2016.
Research and development expenses were $1.3 million compared to
$2.5 million for the same period in 2016. The decrease was
primarily due to reduced study and clinical supply costs associated
with completion of the SEAMLESS study and 2016 expenditure related
the development of CYC140.
General and administrative expenses were $1.4
million for each of the three months ended March 31, 2016 and
2017.
Other income, net for the three months ended March 31, 2017 was
$0.8 million, compared to $0.2 million for the same period of the
previous year. The increase is primarily related to income received
under an Asset Purchase Agreement with Life Technologies
Corporation, or LTC, (formerly Invitrogen Corporation), in respect
of certain assets and intellectual property sold by the Company to
LTC in December 2005.
The United Kingdom research & tax credit was $0.3 million
for the three months ended March 31, 2017 compared to $0.5 million
for the same period in 2016. The cash receipt for the 2016 tax
credit of approximately $2.0 million is expected to be received in
the second quarter of 2017.
After taking into account the expected $2.0 million cash receipt
above and sales of common stock totaling $1.0 million from the at
the market facility, pro forma cash at March 31, 2017 is
approximately $15.7 million. The Company expects current pro forma
cash to fund operations and ongoing programs to the end of
2018.
Net loss for the three months ended March 31, 2017 was $1.6
million compared to $3.0 million for the same period in 2016.
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 19102819
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 cell cycle, transcriptional regulation and DNA damage
response biology to develop innovative, targeted medicines for
cancer and other proliferative diseases. Cyclacel's transcriptional
regulation program is evaluating CYC065, a CDK inhibitor, in
patients with advanced cancers. The DNA damage response program is
evaluating a sequential regimen of sapacitabine and seliciclib, a
CDK inhibitor, in patients with BRCA positive, advanced solid
cancers. Cyclacel is analyzing stratified and exploratory
subgroups from a Phase 3 study of sapacitabine in elderly patients
with AML. 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.
© Copyright 2017 Cyclacel Pharmaceuticals, Inc.
All Rights Reserved. The Cyclacel logo and Cyclacel® are trademarks
of Cyclacel Pharmaceuticals, Inc.
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CYCLACEL PHARMACEUTICALS, INC.
CONSOLIDATED STATEMENTS OF
OPERATIONS(In $000s, except share and per share
amounts) |
|
|
|
|
|
|
|
Three Months Ended March
31, |
|
|
|
2016 |
|
|
|
2017 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(Unaudited) |
Revenues: |
|
|
|
|
|
|
|
|
Grant
revenue |
|
|
$ |
139 |
|
|
|
|
- |
|
Total
revenues |
|
|
|
139 |
|
|
|
|
- |
|
Operating
expenses: |
|
|
|
|
|
|
|
|
Research
and development |
|
|
|
2,499 |
|
|
|
|
1,312 |
|
General
and administrative |
|
|
|
1,384 |
|
|
|
|
1,381 |
|
Total operating
expenses |
|
|
|
3,883 |
|
|
|
|
2,693 |
|
Operating
loss |
|
|
|
(3,744 |
) |
|
|
|
(2,693 |
) |
Other income
(expense): |
|
|
|
|
|
|
|
|
Foreign
exchange gains |
|
|
|
180 |
|
|
|
|
(59 |
) |
Interest
income |
|
|
|
10 |
|
|
|
|
12 |
|
Other
income, net |
|
|
|
20 |
|
|
|
|
879 |
|
Total
other income, net |
|
|
|
210 |
|
|
|
|
832 |
|
Loss from
operations before taxes |
|
|
|
(3,534 |
) |
|
|
|
(1,861 |
) |
Income tax benefit |
|
|
|
493 |
|
|
|
|
306 |
|
Net
loss |
|
|
|
(3,041 |
) |
|
|
|
(1,555 |
) |
Dividend on convertible
exchangeable preferred shares |
|
|
|
(50 |
) |
|
|
|
(50 |
) |
Net loss
applicable to common shareholders |
|
|
$ |
(3,091 |
) |
|
|
|
(1,605 |
) |
Net loss per share —
basic and diluted |
|
|
$ |
(1.04 |
) |
|
|
|
(0.38 |
) |
Weighted average common
shares outstanding |
|
|
|
2,965,208 |
|
|
|
|
4,271,324 |
|
|
|
|
|
|
CYCLACEL PHARMACEUTICALS,
INC.CONSOLIDATED BALANCE
SHEETS(In $000s, except share, per share, and
liquidation preference amounts) |
|
|
|
|
|
|
|
|
|
December 31,2016 |
|
|
|
|
March 31,2017 |
ASSETS |
|
|
|
|
|
|
|
|
|
|
Current assets: |
|
|
|
|
|
|
|
|
|
|
Cash and
cash equivalents |
|
|
|
$ |
16,520 |
|
|
|
$ |
12,729 |
Prepaid
expenses and other current assets |
|
|
|
|
3,097 |
|
|
|
|
4,305 |
Total
current assets |
|
|
|
|
19,617 |
|
|
|
|
17,034 |
Property, plant and
equipment (net) |
|
|
|
|
45 |
|
|
|
|
39 |
Total
assets |
|
|
|
$ |
19,662 |
|
|
|
$ |
17,073 |
LIABILITIES AND
STOCKHOLDERS’ EQUITY |
|
|
|
|
|
|
|
|
|
|
Current
liabilities: |
|
|
|
|
|
|
|
|
|
|
Accounts
payable |
|
|
|
$ |
2,497 |
|
|
|
$ |
1,652 |
Accrued
and other current liabilities |
|
|
|
|
2,762 |
|
|
|
|
2,476 |
Total
current liabilities |
|
|
|
|
5,259 |
|
|
|
|
4,128 |
Other liabilities |
|
|
|
|
130 |
|
|
|
|
127 |
Total
liabilities |
|
|
|
|
5,389 |
|
|
|
|
4,255 |
Stockholders’
equity |
|
|
|
|
14,273 |
|
|
|
|
12,818 |
Total
liabilities and stockholders’ equity |
|
|
|
$ |
19,662 |
|
|
|
$ |
17,073 |
Contacts
Company: Paul McBarron, (908) 517-7330, pmcbarron@cyclacel.com
Investor Relations: Russo Partners LLC, Alexander Fudukidis, (646) 942-5632, alex.fudukidis@russopartnersllc.com
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