Current Report Filing (8-k)
May 14 2015 - 4:47PM
Edgar (US Regulatory)
UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
FORM 8-K
CURRENT REPORT
Pursuant
to Section 13 or 15(d)
of the Securities Exchange Act of 1934
May 14, 2015
Date
of Report (Date of earliest event reported)
Celladon
Corporation
(Exact name of registrant as specified in its charter)
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Delaware |
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001-36183 |
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33-0971591 |
(State or other jurisdiction
of incorporation) |
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(Commission
File Number) |
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(IRS Employer
Identification No.) |
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11988 El Camino Real, Suite 650
San Diego, CA |
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92130 |
(Address of principal executive offices) |
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(Zip Code) |
Registrants telephone number, including area code: (858) 366-4288
Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligations of the registrant under any of the
following provisions:
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Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425) |
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Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12) |
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Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b)) |
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Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c)) |
Item 2.02 |
Results of Operations and Financial Condition. |
On May 14, 2015, we announced our
financial results for the first quarter ended March 31, 2015 in the press release attached hereto as Exhibit 99.1 and incorporated herein by reference.
The information in this Item 2.02 and the attached Exhibit 99.1 is being furnished and shall not be deemed filed for the
purposes of Section 18 of the Securities and Exchange Act of 1934, as amended, or otherwise subject to the liabilities of that Section. The information in this Item 2.02 and the attached Exhibit 99.1 shall not be incorporated by reference
into any registration statement or other document pursuant to the Securities Act of 1933, as amended.
Item 9.01 |
Financial Statements and Exhibits. |
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Exhibit
No. |
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Description |
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99.1 |
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Press release of Celladon Corporation dated May 14, 2015 |
SIGNATURES
Pursuant to the requirements of the Securities Exchange Act of 1934, the Registrant has duly caused this report to be signed on its behalf by
the undersigned hereunto duly authorized.
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Celladon Corporation |
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Dated: May 14, 2015 |
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By: |
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/s/ Paul B. Cleveland |
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Paul B. Cleveland |
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President and Chief Financial Officer |
EXHIBIT INDEX
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Exhibit No. |
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Description |
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99.1 |
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Press release of Celladon Corporation dated May 14, 2015 |
Exhibit 99.1
Celladon Reports First Quarter 2015 Financial Results
SAN DIEGO, CA, May 14, 2015 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)
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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. |
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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 Novaseps facility. |
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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. |
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Celladons Board of Directors approved an approximately 50% reduction of Celladons current full-time workforce of 34 employees in order to reduce operating expenses and conserve cash resources.
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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 CUPID 2
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
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Cash Position: Cash, cash equivalents and investments as of March 31, 2015 were $70.6 million. |
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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. |
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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. |
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Other Expense, Net: Other expense, net was $449 thousand and $238 thousand for the first quarter of 2015 and 2014, respectively. |
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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 Celladons attempt to better understand the observed negative outcome of the CUPID 2 trial, Celladons 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 Celladons 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 Celladons 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 Celladons 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.
# # #
CONTACT:
Fredrik Wiklund
Vice President, Corporate Development and
Investor Relations
(858) 432-7215
Condensed Consolidated Statements of Operations
(in thousands)
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Three Months Ended March 31, |
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2015 |
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2014 |
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(unaudited) |
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Operating expenses: |
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Research and development |
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$ |
11,518 |
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$ |
5,218 |
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General and administrative |
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4,779 |
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1,706 |
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Total operating expenses |
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16,297 |
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6,924 |
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Loss from operations |
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(16,297 |
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(6,924 |
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Other expense, net |
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(449 |
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(238 |
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Consolidated net loss |
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$ |
(16,746 |
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$ |
(7,162 |
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Condensed Consolidated Balance Sheets
(in thousands)
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March 31, 2015 |
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December 31, 2014 |
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(unaudited) |
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Assets |
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Current assets: |
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Cash and cash equivalents |
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$ |
50,018 |
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$ |
14,435 |
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Short-term investments |
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20,570 |
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70,513 |
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Prepaid expenses and other assets |
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1,673 |
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3,135 |
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Total current assets |
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72,261 |
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88,083 |
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Property and equipment, net |
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793 |
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763 |
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Other assets |
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185 |
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264 |
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Total assets |
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$ |
73,239 |
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$ |
89,110 |
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Liabilities, preferred stock and stockholders deficit |
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Current liabilities: |
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Accounts payable and accrued expenses |
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$ |
3,746 |
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$ |
5,803 |
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Accrued clinical expenses |
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646 |
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731 |
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Accrued interest |
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71 |
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71 |
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Current portion of long-term obligations |
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1,671 |
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1 |
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Total current liabilities |
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6,134 |
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6,606 |
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Long-term obligations, net of discount |
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8,710 |
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10,102 |
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Non-current liabilities |
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291 |
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298 |
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Stockholders equity |
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58,104 |
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72,104 |
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Total liabilities, preferred stock and stockholders equity |
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$ |
73,239 |
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$ |
89,110 |
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