Celladon Reports First Quarter 2015 Financial Results
May 14 2015 - 4:30PM
Celladon Corporation (Nasdaq:CLDN), a clinical-stage biotechnology
company with industry-leading expertise in the development of
cardiovascular gene therapy, today announced financial results for
the quarter ended March 31, 2015 and recent corporate updates.
First Quarter 2015 and Recent Corporate
Updates
MYDICAR® (AAV1/SERCA2a)
- In April Celladon announced that its Phase 2b CUPID2 trial did
not meet its primary or secondary endpoints. CUPID2 is a
randomized, double-blind, placebo-controlled, multinational trial
evaluating a single, one-time, intracoronary infusion of the
cardiovascular gene therapy agent MYDICAR® (AAV1/SERCA2a) versus
placebo added to a maximal, optimized heart failure drug and device
regimen.
- Also in April, Celladon terminated the Development,
Manufacturing and Supply Agreement with Novasep, Inc. after
concluding that the recently un-blinded CUPID2 data was such that
Celladon does not require production of MYDICAR drug substance at
Novasep's facility.
- Similarly, Celladon does not intend to exercise the
construction trigger option under the MYDICAR Facility Construction
and Commercial Supply Agreement with Lonza Biologics, Inc., which
will result in the automatic expiration of the agreement in the
second quarter of 2015.
- Celladon's Board of Directors approved an approximately 50%
reduction of Celladon's current full-time workforce of 34 employees
in order to reduce operating expenses and conserve cash
resources.
- Celladon will not be drawing down the second tranche of the
debt facility with Hercules Technology Growth Capital, Inc. and
will begin repaying the $10 million principal currently outstanding
in 30 equal monthly payments of principal and interest starting in
August 2015.
"We are in the process of conducting an extensive review of the
CUPID2 data in the attempt to better understand the observed
negative outcome. Meanwhile, we are conserving our cash resources
and are assessing our other previously planned clinical trials and
development programs. We are also evaluating our strategic options
in order to determine the best path forward to maximize shareholder
value," said Krisztina Zsebo, Ph.D., Chief Executive Officer of
Celladon.
First Quarter 2015 Financial Results
- Cash Position: Cash, cash equivalents and investments as of
March 31, 2015 were $70.6 million.
- Research and Development Expenses: Research and development
expenses were $11.5 million and $5.2 million, respectively, for the
first quarter of 2015 and 2014.
- General and Administrative Expenses: General and administrative
expenses were $4.8 million and $1.7 million, respectively, for the
first quarter of 2015 and 2014.
- Other Expense, Net: Other expense, net was $449 thousand and
$238 thousand for the first quarter of 2015 and 2014, respectively.
- Consolidated Net Loss: Consolidated net loss was $16.7 million
and $7.2 million for the first quarter of 2015 and 2014,
respectively. The consolidated net loss included stock-based
compensation of $2.1 million and $0.5 million for the first quarter
of 2015 and 2014, respectively.
About Celladon
Celladon is a clinical-stage biotechnology company applying its
leadership position in the field of cardiovascular gene therapy to
develop novel therapies for diseases with high unmet medical needs.
Our lead programs target SERCA enzymes which are a family of
enzymes that play an integral part in the regulation of
intra-cellular calcium in all human cells. Calcium dysregulation is
implicated in a number of important and complex medical conditions
and diseases, such as heart failure, vascular disease, diabetes and
neurodegenerative diseases. In addition, the Company conducts
research and development on its mSCF gene therapy program for
cardiac diseases. Celladon has also identified a number of
potential first-in-class compounds addressing novel targets in
diabetes and neurodegenerative diseases with its small molecule
platform of SERCA2b modulators. For more information, please visit
www.celladon.com.
Forward-Looking Statements
Statements contained in this press release regarding matters
that are not historical facts are "forward-looking statements"
within the meaning of the Private Securities Litigation Reform Act
of 1995. Such statements include, but are not limited to,
references to Celladon's attempt to better understand the observed
negative outcome of the CUPID2 trial, Celladon's efforts to
conserve its cash resources and its ongoing assessment of other
previously planned clinical trials and development programs, as
well as its evaluation of strategic options and its ability to
determine and execute on the best path forward to maximize
shareholder value. Because such statements are subject to
risks and uncertainties, actual results may differ materially from
those expressed or implied by such forward-looking statements.
These forward-looking statements are based upon Celladon's current
expectations and involve assumptions that may never materialize or
may prove to be incorrect. Actual results and the timing of
events could differ materially from those anticipated in such
forward-looking statements as a result of various risks and
uncertainties, which include, without limitation, risks and
uncertainties associated with the process of conducting product
development activities and clinical trials and obtaining regulatory
approval to commercialize product candidates, risks and
uncertainties associated with possible changes in the magnitude of
the planned workforce reduction, including as a result of changes
that may occur in Celladon's operations or operating plan, or other
reasons or events, our reliance on third parties and the need to
raise additional funding when needed in order to conduct our
business. These and other risks and uncertainties are
described more fully in Celladon's filings with the Securities and
Exchange Commission, including without limitation its Form 10-Q for
the quarter ended March 31, 2015. All forward-looking
statements contained in this press release speak only as of the
date on which they were made. Celladon undertakes no obligation to
update such statements to reflect events that occur or
circumstances that exist after the date on which they were
made.
Condensed Consolidated
Statements of Operations |
(in
thousands) |
|
|
|
|
Three Months
Ended March 31, |
|
2015 |
2014 |
|
(unaudited) |
Operating expenses: |
|
|
Research and development |
$11,518 |
$5,218 |
General and administrative |
4,779 |
1,706 |
Total operating expenses |
16,297 |
6,924 |
Loss from operations |
(16,297) |
(6,924) |
Other expense, net |
(449) |
(238) |
Consolidated net loss |
$(16,746) |
$(7,162) |
|
Condensed Consolidated
Balance Sheets |
(in
thousands) |
|
|
|
|
March 31, |
December 31, |
|
2015 |
2014 |
|
(unaudited) |
|
Assets |
|
|
Current assets: |
|
|
Cash and cash equivalents |
$ 50,018 |
$ 14,435 |
Short-term investments |
20,570 |
70,513 |
Prepaid expenses and other assets |
1,673 |
3,135 |
Total current assets |
72,261 |
88,083 |
Property and equipment, net |
793 |
763 |
Other assets |
185 |
264 |
Total assets |
$ 73,239 |
$ 89,110 |
|
|
|
Liabilities, preferred stock and
stockholders' deficit |
|
|
Current liabilities: |
|
|
Accounts payable and accrued expenses |
$ 3,746 |
$ 5,803 |
Accrued clinical expenses |
646 |
731 |
Accrued interest |
71 |
71 |
Current portion of long-term obligations |
1,671 |
1 |
Total current liabilities |
6,134 |
6,606 |
Long-term obligations, net of discount |
8,710 |
10,102 |
Non-current liabilities |
291 |
298 |
Stockholders' equity |
58,104 |
72,104 |
Total liabilities, preferred stock and
stockholders' equity |
$ 73,239 |
$ 89,110 |
|
|
|
CONTACT: Fredrik Wiklund
Vice President, Corporate Development and Investor Relations
(858) 432-7215
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