EWING, N.J., Nov. 12, 2015 /PRNewswire/ -- Celator
Pharmaceuticals, Inc. (Nasdaq: CPXX) today reported business
highlights and financial results for the third quarter
ended September 30, 2015.
"The momentum builds as we continue to deliver on our
milestones, from the induction response rate improvement observed
in our Phase 3 study with VYXEOS™ (formerly CPX-351) and announced
last quarter, to impressive results from data packages on novel
combination programs," said Scott Jackson, Chief Executive
Officer of the Company. "The external validation of our
proprietary technologies, as evidenced with VYXEOS being selected
as the Nanomedicine Product of the Year is very exciting. We expect
the overall survival data from the Phase 3 study in the first
quarter of 2016."
Third Quarter 2015 and Recent Highlights:
- Celator will receive more than $1.675
million from the sale of its net operating losses and
research and development credits under the New Jersey Technology
Business Tax Certificate Transfer Program. The Company expects to
receive this amount by the end of 2015.
- Pre-clinical data presented at the AACR-NCI-EORTC International
Conference on Molecular Targets and Cancer Therapeutics
demonstrated the broad applicability of Celator's hydrophobic
prodrug nanoparticle (HPN) delivery technology to molecularly
targeted agents, including inhibitors of MEK, Akt, HSP90 and
B-Raf. Significant efficacy improvements for HPN
co-formulated combinations over conventional administration of
targeted agent regimens were reported.
- VYXEOS (formerly CPX-351) was selected the Best Nanomedicine
Product of the Year by a panel of pharmaceutical industry
specialists that recognizes innovative product developments in
nanomedicine.
- Celator announced top-line results from an intensive QT/QTc
study showing VYXEOS has no QT/QTc interval prolongation and that
additional data will be presented at the upcoming American Society
of Hematology (ASH) Annual Meeting. This study was conducted to
support the New Drug Application for VYXEOS which the Company plans
to file in the third quarter of 2016.
- The Independent Data and Safety Monitoring Board (DSMB) for the
Company's Phase 3 clinical study with VYXEOS has completed the
final pre-planned safety review of all patients and has again
recommended the study continue as planned without any
modifications.
- Patients began enrolling in an investigator-initiated Phase 2
clinical study evaluating VYXEOS as a treatment for patients with
newly diagnosed acute myeloid leukemia (AML) at high risk for
induction treatment mortality.
- Celator's senior management team hosted an Analyst and Investor
Day to discuss the company's growth strategy, its lead product
candidate, VYXEOS, and its proprietary CombiPlex® technology
platform.
- Michael R. Dougherty was
appointed Executive Chairman of the Board of Directors. Mr.
Dougherty has been a director of Celator since July 2013 and served as Chairman since
September 2014.
Financial Highlights:
- Cash Position: Cash and cash equivalents as
of September 30, 2015 were $24.1 million, compared
to $32.4 million as of December 31, 2014. The
decrease was primarily due to $13.3 million of net cash
used in operating activities, partially offset
by $5.0 million in proceeds from the final draw down
of the Hercules Technology Growth Capital loan. Cash and cash
equivalents as of June 30, 2015 were
$28.5 million. Management believes
that the cash and cash equivalents at September 30,
2015 will be sufficient to meet estimated working capital
requirements and fund planned operations into the second half of
2016.
- R&D Expenses: Research and development expenses
were $2.9 million and $9.0 million for the
three and nine months ended September 30, 2015, as
compared to $3.3 million and $9.2 million for the
same periods in 2014. The decrease in R&D expenses in the
comparable three-month and nine-month periods were primarily due to
decreases in regulatory and clinical trial costs related to the
Phase 3 study of VYXEOS and manufacturing and drug costs.
- G&A Expenses: General and administrative
expenses were $1.9 million and $5.7
million for the three and nine months ended September 30,
2015, as compared to $1.9 million and $5.5
million for the same periods of 2014. The increase in the
comparable nine-month period was primarily attributable to
increases in compensation, public company expenses and professional
fees offset by reductions in consulting and recruiting fees.
- Net Loss: Net loss was $5.2 million
and $14.9 million for the three and nine months
ended September 30, 2015, as compared to $5.5 million
and $14.5 million for the same periods in
2014.
Conference Call Information:
Celator will host a conference call and live audio webcast today
at 4:30 p.m. ET to provide a business update and discuss
the third quarter 2015 financial results. To participate in the
conference call, please dial (877) 303-6316 (domestic) or
(650) 521-5176 (international) and refer to conference ID
75399779. The live webcast of the call can be accessed in the
Investors section of Celator's website
at www.celatorpharma.com. An archived webcast will
be available on Celator's website beginning approximately two hours
after the event.
About Celator Pharmaceuticals, Inc.
Celator Pharmaceuticals, Inc., with locations in Ewing, N.J., and Vancouver, B.C., is a clinical stage
biopharmaceutical company that is transforming the science of
combination therapy, and developing products to improve patient
outcomes in cancer. Celator's proprietary technology platform,
CombiPlex®, enables the rational design and rapid evaluation of
optimized combinations incorporating traditional chemotherapies as
well as molecularly targeted agents to deliver enhanced anti-cancer
activity. CombiPlex addresses several fundamental
shortcomings of conventional combination regimens, as well as the
challenges inherent in combination drug development, by identifying
the most effective synergistic molar ratio of the drugs being
combined in vitro, and fixing this ratio in a nano-scale
drug delivery complex to maintain the optimized combination after
administration and ensure its exposure to the tumor.
Celator's pipeline includes lead product, VYXEOS™ (formerly
CPX-351), a liposomal formulation of cytarabine:daunorubicin being
studied for the treatment of acute myeloid leukemia; CPX-1, a
liposomal formulation of irinotecan:floxuridine being studied for
the treatment of colorectal cancer; and a preclinical stage product
candidate, CPX-8, a hydrophobic docetaxel prodrug nanoparticle
formulation, being studied by the National Cancer Institute's
Nanotechnology Characterization Laboratory. The company is
advancing the CombiPlex platform and broadening its application to
include molecularly targeted therapies. The company is
seeking research and development collaborations, applying its
proprietary technologies, with other biotechnology/pharmaceutical
companies.
For more information, please visit Celator's website at
www.celatorpharma.com. Information on ongoing trials is available
at www.clinicaltrials.gov.
Forward-Looking Statements:
To the extent that statements contained in this press release
are not descriptions of historical facts regarding Celator, they
are forward-looking statements reflecting the current beliefs and
expectations of management made pursuant to the safe harbor
provisions of the Private Securities Litigation Reform Act of 1995.
Words such as "may," "will," "expect," "anticipate," "estimate,"
"intend, and similar expressions (as well as other words or
expressions referencing future events, conditions or circumstances)
are intended to identify forward-looking statements. Examples of
forward-looking statements contained in this press release include,
among others, statements regarding the safety, potential efficacy
and therapeutic potential of VYXEOS (formerly CPX-351), the
availability and timing of release of data from clinical studies,
our expectations regarding our research and development programs,
expanding our pipeline and advancing our CombiPlex platform, and
our expectation regarding the sufficiency of our working capital.
Forward-looking statements in this release involve substantial
risks and uncertainties that could cause our research and
development programs, future results, working capital, performance
or achievements to differ significantly from those expressed or
implied by the forward-looking statements. Such risks and
uncertainties include, among others, the uncertainties inherent in
the conduct of clinical studies, enrollment in clinical studies,
availability of data from ongoing clinical studies, whether
clinical study results for VYXEOS obtained to date will be
predictive of future results, regulatory risks and uncertainties
and other matters that could affect the commercial potential of our
drug candidates, our ability to raise capital and the trading of
our common stock. Celator undertakes no obligation to update or
revise any forward-looking statements. For a further description of
the risks and uncertainties that could cause actual results to
differ from those expressed in these forward-looking statements, as
well as risks relating to the business of Celator in general, see
Celator's Form 10-K for the year ended December 31, 2014, subsequent reports on
Form 10-Q and 8-K, and other filings by Celator with the
U.S. Securities and Exchange Commission.
Celator
Pharmaceuticals, Inc. and Subsidiaries
|
Consolidated
Balance Sheets
|
(Unaudited)
|
|
|
|
|
|
|
|
|
|
|
|
|
September 30,
2015
|
|
December 31,
2014
|
|
Assets
|
|
|
|
|
Current
assets:
|
|
|
|
|
Cash and cash
equivalents
|
$
24,104,631
|
|
$
32,413,777
|
|
Restricted
cash
|
190,082
|
|
194,561
|
|
Other
receivables
|
78,252
|
|
21,102
|
|
Prepaid expenses and
deposits
|
513,995
|
|
482,472
|
|
Other current
assets
|
419,376
|
|
458,278
|
|
Total current
assets
|
25,306,336
|
|
33,570,190
|
|
Property and
equipment, net
|
900,836
|
|
1,004,412
|
|
Other
assets
|
543,250
|
|
544,501
|
|
Total
assets
|
$
26,750,422
|
|
$
35,119,103
|
|
|
|
|
|
|
Liabilities
|
|
|
|
|
Current
liabilities:
|
|
|
|
|
Current portion of
debt
|
$
4,416,459
|
|
$
284,961
|
|
Accounts
payable
|
304,463
|
|
723,765
|
|
Accrued
liabilities
|
2,313,482
|
|
1,735,420
|
|
Current portion of
deferred revenue
|
180,995
|
|
542,986
|
|
Total current
liabilities
|
7,215,399
|
|
3,287,132
|
|
|
|
|
|
|
Deferred
revenue
|
-
|
|
45,249
|
|
Deferred
rent
|
38,155
|
|
45,408
|
|
Loan
payable
|
10,840,263
|
|
9,836,256
|
|
Total
liabilities
|
18,093,817
|
|
13,214,045
|
|
|
|
|
|
|
Stockholders'
equity
|
|
|
|
|
Preferred
stock
|
|
|
|
|
Authorized 20,000,000
shares, par value $0.001
|
-
|
|
-
|
|
Common
stock
|
|
|
|
|
Authorized
200,000,000 shares, par value $0.001
|
|
|
|
|
Issued and
outstanding 33,799,539 and 33,681,355 shares as of September 30,
2015 and December 31, 2014, respectively
|
33,800
|
|
33,681
|
|
Warrants
|
1,083,193
|
|
1,083,193
|
|
Additional paid-in
capital
|
172,943,931
|
|
171,289,703
|
|
Accumulated other
comprehensive loss
|
(1,133,266)
|
|
(1,133,266)
|
|
Accumulated
deficit
|
(164,271,053)
|
|
(149,368,253)
|
|
Total stockholders'
equity
|
8,656,605
|
|
21,905,058
|
|
Total liabilities
and stockholders' equity
|
$
26,750,422
|
|
$
35,119,103
|
|
|
|
|
|
Celator
Pharmaceuticals, Inc. and Subsidiaries
|
Consolidated
Statements of Loss
|
(Unaudited)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Three months
ended
|
|
Nine months
ended
|
|
|
|
September
30,
|
|
September
30,
|
|
|
|
2015
|
|
2014
|
|
2015
|
|
2014
|
|
Expenses
|
|
|
|
|
|
|
|
|
|
Research and
development
|
|
$ 2,859,852
|
|
$ 3,334,789
|
|
$
9,020,994
|
|
$
9,238,756
|
|
Leukemia &
Lymphoma Society funding
|
|
(135,747)
|
|
(135,747)
|
|
(1,307,240)
|
|
(907,240)
|
|
General and
administrative
|
|
1,943,003
|
|
1,874,412
|
|
5,718,986
|
|
5,491,779
|
|
Amortization and
depreciation
|
|
49,740
|
|
48,521
|
|
148,062
|
|
144,609
|
|
Operating
loss
|
|
(4,716,848)
|
|
(5,121,975)
|
|
(13,580,802)
|
|
(13,967,904)
|
|
Other income
(expenses)
|
|
|
|
|
|
|
|
|
|
Foreign exchange
loss
|
|
(8,631)
|
|
(1,408)
|
|
(20,894)
|
|
(27,721)
|
|
Interest and
miscellaneous income
|
|
248
|
|
2,887
|
|
6,500
|
|
7,144
|
|
Interest
expense
|
|
(485,060)
|
|
(359,321)
|
|
(1,307,604)
|
|
(560,031)
|
|
Net
loss
|
|
$ (5,210,291)
|
|
$ (5,479,817)
|
|
$ (14,902,800)
|
|
$ (14,548,512)
|
|
|
|
|
|
|
|
|
|
|
|
Net loss per
share
|
|
|
|
|
|
|
|
|
|
Basic and
diluted
|
|
$
(0.15)
|
|
$
(0.21)
|
|
$
(0.44)
|
|
$
(0.56)
|
|
|
|
|
|
|
|
|
|
|
|
Weighted average of
common shares outstanding
|
|
|
|
|
|
|
|
|
|
Basic
and diluted
|
|
33,799,539
|
|
26,078,532
|
|
33,759,351
|
|
26,065,006
|
|
|
|
|
|
|
|
|
|
|
CONTACTS:
Media:
Mike Beyer
Sam Brown, Inc.
312-961-2502
beyer@sambrown.com
Investors:
Adam Krop
The Trout Group
646-378-2963
akrop@troutgroup.com
To view the original version on PR Newswire,
visit:http://www.prnewswire.com/news-releases/celator-pharmaceuticals-announces-third-quarter-2015-financial-results-and-business-update-300178011.html
SOURCE Celator Pharmaceuticals, Inc.