Celladon Reports Fourth Quarter and Year-End 2014 Financial Results and Recent Highlights
March 30 2015 - 4:05PM
CUPID2 Topline Data Release on Track for
Late April
Conference Call March 31, 2015 at 8:30
a.m. Eastern Time
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 and year ended December 31, 2014 and recent corporate
highlights.
"In the last year, Celladon has made significant progress in our
clinical programs and pre-commercial planning for MYDICAR,
including preparations for commercial manufacturing and other long
lead-time activities. Our CUPID2 trial is evaluating the use of
MYDICAR to treat systolic heart failure, known as HFrEF, and we
received Breakthrough Therapy designation for this program from the
FDA in April of last year. The CUPID2 trial is proceeding according
to plan and we look forward to un-blinding and announcing top-line
data from this trial in late April 2015. Following last year's
financing activities, we are well positioned to advance our
pipeline and development initiatives in 2015," said Krisztina
Zsebo, Ph.D., Chief Executive Officer of Celladon.
Fourth Quarter 2014 and Recent Corporate
Highlights
MYDICAR®
- In February 2015, we reached the last subject's last visit
during the 12 month primary data analysis period in the CUPID2
study, thereby reaching the study's primary analysis data cutoff.
We remain on track to un-blind the data and announce top-line
results from this study in late April 2015.
- In December 2014, we commenced work with Novasep, Inc.
(Novasep) for the potential future commercial manufacture of
MYDICAR drug substance (AAV1/SERCA2a), and in March 2015, we
announced the execution of a development, manufacturing and supply
agreement with Novasep, which, if supported by the CUPID2 data,
positions the parties to continue with the process transfer,
facility retrofitting, development and manufacturing activities
necessary for the future commercial supply of MYDICAR drug
substance. If we proceed with the ongoing activities beyond a
specified termination period following the un-blinding of CUPID2,
we would commit to a multi-year agreement for the future commercial
supply of MYDICAR drug substance.
- In November 2014, we announced the execution of a facility
construction and commercial supply agreement with Lonza Biologics,
Inc. (Lonza). In exchange for a reservation fee, we have the
option, exercisable during a specified timeframe and with further
financial obligation, to have Lonza commence construction of a new
commercial viral therapeutics manufacturing facility, the exercise
of which would commit us to a multi-year agreement for the future
commercial supply of MYDICAR drug substance.
- In December 2014, we conducted initial scale up of our MYDICAR
(AAV1/SERCA2a) viral manufacturing process to 2,000 liter
commercial scale, completing the first demonstration batch at
Lonza's Houston facility.
Fourth Quarter and Year-End 2014 Financial
Results
- Cash Position: Cash, cash equivalents and investments as of
December 31, 2014 were $84.9 million.
- Research and Development Expenses: Research and development
expenses were $7.2 million and $5.2 million for the fourth quarter
of 2014 and 2013, respectively. Research and development expenses
were $22.7 million and $16.9 million for the years ended December
31, 2014 and 2013, respectively.
- General and Administrative Expenses: General and administrative
expenses were $3.8 million and $0.8 million for the fourth quarter
of 2014 and 2013, respectively. General and administrative expenses
were $10.3 million and $3.0 million for the years ended December
31, 2014 and 2013, respectively.
- Other Expense, Net: Other expense, net was $0.4 million and
$0.2 million for the fourth quarter of 2014 and 2013, respectively.
Other expense was $0.8 million and $0.1 million for the years ended
2014 and 2013, respectively.
- Consolidated Net Loss: Consolidated net loss was $11.3 million
and $6.2 million for the fourth quarter of 2014 and 2013,
respectively. Consolidated net loss was $33.9 million and $20.1
million for the years ended December 31, 2014 and 2013,
respectively. The consolidated net loss included stock-based
compensation of $1.1 million and $0.3 million for the fourth
quarter of 2014 and 2013, respectively and $3.3 million and $1.4
million for the years ended December 31, 2014 and 2013,
respectively.
Conference Call & Webcast
Management will host an investment community conference call to
discuss financial results, provide a business update and answer
questions.
|
|
Tuesday, March 31, 2015 @
8:30am Eastern Time/5:30am Pacific Time |
Domestic: |
855-455-6053 |
International: |
484-756-4307 |
Conference ID: |
80188767 |
Webcast: |
www.celladon.com |
|
|
Replays – Available through April
14, 2015 |
Domestic: |
855-859-2056 |
International: |
404-537-3406 |
Conference ID: |
80188767 |
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 tremendous 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. MYDICAR, the Company's most advanced
product candidate, uses gene therapy to target SERCA2a, which is an
enzyme that becomes deficient in patients with advanced heart
failure. Celladon's CUPID2 trial is a 250 patient Phase 2b clinical
trial evaluating the efficacy of MYDICAR in reducing the frequency
of, or delaying heart failure-related hospitalizations. This
randomized, double-blind, placebo-controlled, multinational trial
is evaluating a single intracoronary infusion of MYDICAR versus
placebo added to a maximal, optimized heart failure regimen in
patients with New York Heart Association class III or IV symptoms
of chronic heart failure due to systolic dysfunction, or HFrEF. The
Company has received Breakthrough Therapy designation from the FDA
for this MYDICAR program and expects to report results from the
Phase 2b clinical trial in late April 2015. 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 the expected timing of un-blinding and announcing
top-line CUPID2 data; the impact of Breakthrough Therapy
designation for MYDICAR; the potential future commercial production
of MYDICAR drug substance by Novasep and/or Lonza, including
Celladon's decision and ability to continue activities under one or
both of these agreements following the un-blinding of CUPID2 data;
as well as Celladon's ability to advance its pipeline and
development initiatives in 2015. 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, our
reliance on third parties, the need to raise additional funding
when needed in order to conduct our business, and the degree of
market acceptance of MYDICAR by physicians, patients, third-party
payors and others in the medical community. 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 September
30, 2014. 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 December 31, |
Years Ended
December 31, |
|
2014 |
2013 |
2014 |
2013 |
|
(unaudited) |
|
|
Operating expenses: |
|
|
|
|
Research and development |
$ 7,161 |
$ 5,220 |
$ 22,676 |
$ 16,927 |
General and administrative |
3,797 |
757 |
10,342 |
3,037 |
Total operating expenses |
10,958 |
5,977 |
33,018 |
19,964 |
Loss from operations |
(10,958) |
(5,977) |
(33,018) |
(19,964) |
Other income (expense), net |
(383) |
(202) |
(835) |
(127) |
Consolidated net loss |
$ (11,341) |
$ (6,179) |
$ (33,853) |
$ (20,091) |
|
Condensed Consolidated
Balance Sheets (in thousands)
|
|
December
31, |
|
2014 |
2013 |
Assets |
|
|
Current assets: |
|
|
Cash and cash equivalents |
$ 14,435 |
$ 7,903 |
Short-term investments |
70,513 |
10,467 |
Prepaid expenses and other assets |
3,135 |
180 |
Total current assets |
88,083 |
18,550 |
Property and equipment, net |
763 |
308 |
Other assets |
264 |
2,296 |
Total assets |
$ 89,110 |
$ 21,154 |
|
|
|
Liabilities, preferred stock and
stockholders' deficit |
|
|
Current liabilities: |
|
|
Accounts payable and accrued expenses |
$ 5,803 |
$ 2,908 |
Accrued clinical expenses |
731 |
1,478 |
Accrued interest |
71 |
14 |
Long term obligations, current portion |
1 |
— |
Convertible notes, net of discount |
— |
1,044 |
Warrant liability |
— |
1,116 |
Total current liabilities |
6,606 |
6,560 |
Term loan, net of discount |
10,102 |
— |
Non-current liabilities |
298 |
37 |
Preferred stock |
— |
65,548 |
Stockholders' equity (deficit) |
72,104 |
(50,991) |
Total liabilities, preferred stock and
stockholders' equity (deficit) |
$ 89,110 |
$ 21,154 |
CONTACT: Fredrik Wiklund
Vice President, Corporate Development and Investor Relations
(858) 432-7215
fwiklund@celladon.com
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