Document_and_Entity_Informatio
Document and Entity Information | 3 Months Ended | |
Mar. 31, 2015 | Apr. 30, 2015 | |
Document And Entity Information [Abstract] | ||
Document Type | 10-Q | |
Amendment Flag | FALSE | |
Document Period End Date | 31-Mar-15 | |
Document Fiscal Year Focus | 2015 | |
Document Fiscal Period Focus | Q1 | |
Trading Symbol | CLDN | |
Entity Registrant Name | CELLADON CORPORATION | |
Entity Central Index Key | 1305253 | |
Current Fiscal Year End Date | -19 | |
Entity Filer Category | Non-accelerated Filer | |
Entity Common Stock, Shares Outstanding | 23,907,212 |
Consolidated_Balance_Sheets
Consolidated Balance Sheets (USD $) | Mar. 31, 2015 | Dec. 31, 2014 |
In Thousands, unless otherwise specified | ||
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 |
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 |
Commitments and contingencies (Note 5) | ||
Stockholders' equity: | ||
Preferred stock, $0.001 par value; authorized shares - 10,000,000 at March 31, 2015 and December 31, 2014, respectively; no shares issued and outstanding | ||
Common stock, $0.001 par value; authorized shares - 200,000,000 at March 31, 2015 and December 31, 2014, respectively; issued and outstanding - 23,827,918 and 23,490,737 at March 31, 2015 and December 31, 2014, respectively | 24 | 23 |
Additional paid-in capital | 221,266 | 218,528 |
Accumulated other comprehensive loss | -1 | -8 |
Accumulated deficit | -163,185 | -146,439 |
Total stockholders' equity | 58,104 | 72,104 |
Total liabilities and stockholders' equity | $73,239 | $89,110 |
Consolidated_Balance_Sheets_Pa
Consolidated Balance Sheets (Parenthetical) (USD $) | Mar. 31, 2015 | Dec. 31, 2014 |
Statement of Financial Position [Abstract] | ||
Preferred stock, par value | $0.00 | $0.00 |
Preferred stock, shares authorized | 10,000,000 | 10,000,000 |
Preferred stock, shares issued | 0 | 0 |
Preferred stock, shares outstanding | 0 | 0 |
Common stock, par value | $0.00 | $0.00 |
Common stock, shares authorized | 200,000,000 | 200,000,000 |
Common stock, shares issued | 23,827,918 | 23,490,737 |
Common stock, shares outstanding | 23,827,918 | 23,490,737 |
Consolidated_Statements_of_Ope
Consolidated Statements of Operations and Comprehensive Loss (Unaudited) (USD $) | 3 Months Ended | |
In Thousands, except Share data, unless otherwise specified | Mar. 31, 2015 | Mar. 31, 2014 |
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 income (expense): | ||
Interest income | 40 | 8 |
Interest expense | -510 | -59 |
Other income (expense) | 21 | -4 |
Change in fair value of warrant liability | -183 | |
Consolidated net loss | -16,746 | -7,162 |
Other comprehensive gain (loss): | ||
Unrealized gain (loss) on investments | 7 | -2 |
Comprehensive loss | ($16,739) | ($7,164) |
Net loss per share attributable to common stockholders, basic and diluted | ($0.71) | ($0.60) |
Weighted-average shares outstanding, basic and diluted | 23,667,800 | 11,939,866 |
Consolidated_Statements_of_Cas
Consolidated Statements of Cash Flows (Unaudited) (USD $) | 3 Months Ended | |
In Thousands, unless otherwise specified | Mar. 31, 2015 | Mar. 31, 2014 |
Cash flows from operating activities | ||
Consolidated net loss | ($16,746) | ($7,162) |
Adjustments to reconcile net loss to net cash used in operating activities | ||
Depreciation | 76 | 26 |
Stock-based compensation | 2,103 | 519 |
Noncash interest expense | 301 | 59 |
Amortization of investment premium | 148 | 13 |
Change in fair value of warrant liability | 183 | |
Gain on disposal of property and equipment | -1 | |
Deferred rent | -4 | -1 |
Changes in operating assets and liabilities: | ||
Prepaid expenses and other assets | 1,518 | -403 |
Accounts payable and accrued expenses | -2,160 | 219 |
Net cash used in operating activities | -14,765 | -6,547 |
Cash flows from investing activities | ||
Purchases of investment securities | -250 | |
Proceeds from maturities of investment securities | 49,802 | 6,950 |
Purchases of property and equipment | -94 | -212 |
Proceeds from sale of property and equipment | 4 | |
Net cash provided by investing activities | 49,712 | 6,488 |
Cash flows from financing activities | ||
Proceeds from issuance of common stock | 636 | 50,600 |
Costs paid in connection with common stock offering | -4,567 | |
Net cash provided by financing activities | 636 | 46,033 |
Net increase in cash and cash equivalents | 35,583 | 45,974 |
Cash and cash equivalents, beginning of period | 14,435 | 7,903 |
Cash and cash equivalents, end of period | $50,018 | $53,877 |
Basis_of_Presentation_Organiza
Basis of Presentation, Organization and Summary of Significant Accounting Policies | 3 Months Ended | ||||||||||||||||||||
Mar. 31, 2015 | |||||||||||||||||||||
Accounting Policies [Abstract] | |||||||||||||||||||||
Basis of Presentation, Organization and Summary of Significant Accounting Policies | 1. Basis of Presentation, Organization and Summary of Significant Accounting Policies | ||||||||||||||||||||
Basis of Presentation | |||||||||||||||||||||
The accompanying unaudited consolidated financial statements of Celladon Corporation (Celladon or the Company) should be read in conjunction with the audited financial statements and notes thereto as of and for the year ended December 31, 2014 included in the Company’s Annual Report on Form 10-K (Annual Report) filed with the Securities and Exchange Commission (SEC). The accompanying financial statements have been prepared in accordance with U.S. generally accepted accounting principles (GAAP) for interim financial information and in accordance with the instructions to Form 10-Q and Article 10 of Regulation S-X. Accordingly, since they are interim statements, the accompanying financial statements do not include all of the information and notes required by GAAP for complete financial statements. In the opinion of management, the accompanying financial statements reflect all adjustments (consisting of normal recurring adjustments) that are necessary for a fair statement of the financial position, results of operations and cash flows for the interim periods presented. Interim results are not necessarily indicative of results for a full year. The preparation of the Company’s consolidated financial statements requires it to make estimates and assumptions that impact the reported amounts of assets, liabilities and expenses and the disclosure of contingent assets and liabilities in the Company’s consolidated financial statements and accompanying notes. The most significant estimates in the Company’s consolidated financial statements relate to the fair value of equity awards and clinical trial expense accruals. Although these estimates are based on the Company’s knowledge of current events and actions it may undertake in the future, actual results may ultimately materially differ from these estimates and assumptions. | |||||||||||||||||||||
Organization | |||||||||||||||||||||
Celladon was incorporated in California on December 21, 2000 (inception) and reincorporated in Delaware in April 2012. The Company is a clinical-stage biotechnology with industry-leading expertise in the development of cardiovascular gene therapy. | |||||||||||||||||||||
As of March 31, 2015, the Company has devoted substantially all of its efforts to product development, raising capital and building infrastructure and has not generated revenues from its planned principal operations. | |||||||||||||||||||||
Principles of Consolidation | |||||||||||||||||||||
The financial statements of the Company’s former subsidiary Celladon Europe B.V. (Celladon Europe) were consolidated with those of the Company through Celladon Europe’s dissolution on December 30, 2014. All intercompany transactions and balances were eliminated in consolidation. | |||||||||||||||||||||
Investment Securities | |||||||||||||||||||||
Investment securities primarily consist of investment grade corporate debt securities. The Company classifies all investment securities as available-for-sale. Investments with maturity dates greater than 12 months from the end of each reporting period are classified as long-term. Investment securities are carried at fair value, with the unrealized gains and losses reported as a component of other comprehensive income (loss) in stockholders’ equity (deficit) until realized. Realized gains and losses from the sale of investment securities, if any, are determined on a specific identification basis. A decline in the market value of any investment security below cost that is determined to be other than temporary will result in an impairment charge to earnings and a new cost basis for the security is established. No such impairment charges were recorded for any period presented. As of March 31, 2015 and December 31, 2014, none of the investment securities have been in an unrealized loss position for more than 12 months. Premiums and discounts are amortized or accreted over the life of the related security as an adjustment to yield using the straight-line method and are included in interest income. Interest income is recognized when earned. | |||||||||||||||||||||
The following table sets forth the composition of the Company’s investment securities (in thousands): | |||||||||||||||||||||
Unrealized | |||||||||||||||||||||
As of March 31, 2015 | Maturity in Years | Amortized | Gains | Losses | Fair | ||||||||||||||||
Cost | Value | ||||||||||||||||||||
Corporate debt securities | Less than 1 year | $ | 20,571 | $ | — | $ | (1 | ) | $ | 20,570 | |||||||||||
Unrealized | |||||||||||||||||||||
As of December 31, 2014 | Maturity in Years | Amortized | Gains | Losses | Fair | ||||||||||||||||
Cost | Value | ||||||||||||||||||||
Corporate debt securities | Less than 1 year | $ | 70,521 | $ | — | $ | (8 | ) | $ | 70,513 | |||||||||||
Net Loss Per Share Attributable to Common Stockholders | |||||||||||||||||||||
Basic and diluted net loss per common share is calculated by dividing net loss applicable to common stockholders by the weighted-average number of common shares outstanding during the period, without consideration for common stock equivalents. Potentially dilutive shares, which include convertible preferred stock and rights to acquire convertible preferred stock (non-controlling interest), warrants for the purchase of common stock and options outstanding under the Company’s equity incentive plans, are considered to be common stock equivalents and are only included in the calculation of diluted net loss per share when their effect is dilutive. | |||||||||||||||||||||
Potentially dilutive securities not included in the calculation of diluted net loss per share attributable to common stockholders because to do so would be anti-dilutive are as follows (in common stock equivalent shares): | |||||||||||||||||||||
Three Months Ended | |||||||||||||||||||||
March 31, | |||||||||||||||||||||
2015 | 2014 | ||||||||||||||||||||
Warrants for common stock | 152,735 | 231,821 | |||||||||||||||||||
Common stock options and restricted stock units | 3,400,097 | 2,060,890 | |||||||||||||||||||
3,552,832 | 2,292,711 | ||||||||||||||||||||
Recent Accounting Pronouncements | |||||||||||||||||||||
In April 2015, the FASB issued ASU No. 2015-03, Interest - Imputation of Interest (Subtopic 835-30): Simplifying the Presentation of Debt Issuance Costs. The amendments in this ASU require that debt issuance costs related to a recognized debt liability be presented in the balance sheet as a direct deduction from the carrying amount of that debt liability, consistent with debt discounts. The amendments in this ASU are effective for financial statements issued for fiscal years beginning after December 15, 2015, and interim periods within those fiscal years. Early adoption of the amendments is permitted. The new guidance shall be applied on a retrospective basis, wherein the balance sheet of each individual period presented should be adjusted to reflect the period-specific effects of applying the new guidance. The Company is currently evaluating the impact of the adoption of this standard on its consolidated financial statements. |
Balance_Sheet_Details
Balance Sheet Details | 3 Months Ended | ||||||||
Mar. 31, 2015 | |||||||||
Organization, Consolidation and Presentation of Financial Statements [Abstract] | |||||||||
Balance Sheet Details | 2. Balance Sheet Details | ||||||||
Prepaid expenses and other assets consist of the following (in thousands): | |||||||||
March 31, | December 31, | ||||||||
2015 | 2014 | ||||||||
Prepaid expenses | 1,443 | 756 | |||||||
Commercial manufacturing costs (1) | — | 1,751 | |||||||
Other receivables | 158 | 628 | |||||||
Debt issue costs, current | 72 | — | |||||||
$ | 1,673 | $ | 3,135 | ||||||
-1 | The commercial manufacturing costs consisted mainly of design and engineering services for commercial drug manufacturing capabilities. The Company determined that it was probable that it would not complete the commercial manufacturing project in light of the negative CUPID 2 data. The Company therefore recorded the costs accumulated as of December 31, 2014 and activity in the first quarter of 2015 as a period expense in the consolidated financial statements in the three month period ending March 31, 2015. | ||||||||
Property and equipment consist of the following (in thousands): | |||||||||
March 31, | December 31, | ||||||||
2015 | 2014 | ||||||||
Office furniture and other equipment | $ | 905 | $ | 881 | |||||
Leasehold improvements | 247 | 246 | |||||||
Construction in progress | 81 | — | |||||||
Accumulated depreciation | (440 | ) | (364 | ) | |||||
$ | 793 | $ | 763 | ||||||
Accounts payable and accrued expenses consist of the following (in thousands): | |||||||||
March 31, | December 31, | ||||||||
2015 | 2014 | ||||||||
Accounts payable | $ | 2,790 | $ | 3,293 | |||||
Accrued compensation | 361 | 1,909 | |||||||
Accrued other | 587 | 596 | |||||||
Current portion of deferred rent | 8 | 5 | |||||||
$ | 3,746 | $ | 5,803 | ||||||
Fair_Value_Measurements
Fair Value Measurements | 3 Months Ended | ||||||||||||||||
Mar. 31, 2015 | |||||||||||||||||
Fair Value Disclosures [Abstract] | |||||||||||||||||
Fair Value Measurements | 3. Fair Value Measurements | ||||||||||||||||
The Company’s financial instruments primarily consist of cash and cash equivalents, investment securities, accounts payable and accrued liabilities. The carrying value of these financial instruments generally approximates fair value due to their short-term nature. Investment securities are recorded at fair value. | |||||||||||||||||
The accounting guidance defines fair value, establishes a consistent framework for measuring fair value and expands disclosure for each major asset and liability category measured at fair value on either a recurring or nonrecurring basis. Fair value is defined as an exit price, representing the amount that would be received to sell an asset or paid to transfer a liability in an orderly transaction between market participants. As such, fair value is a market-based measurement that should be determined based on assumptions that market participants would use in pricing an asset or liability. As a basis for considering such assumptions, the accounting guidance establishes a three-tier fair value hierarchy, which prioritizes the inputs used in measuring fair value as follows: | |||||||||||||||||
Level 1: Observable inputs such as quoted prices in active markets; | |||||||||||||||||
Level 2: Inputs, other than the quoted prices in active markets, that are observable either directly or indirectly; and | |||||||||||||||||
Level 3: Unobservable inputs in which there is little or no market data, which require the reporting entity to develop its own assumptions | |||||||||||||||||
As of March 31, 2015 and December 31, 2014, cash and cash equivalents consist primarily of bank deposits with third-party financial institutions and highly liquid money market securities with original maturities at date of purchase of 90 days or less and are stated at cost which approximate fair value and are classified within the Level 1 designation discussed above. Marketable securities are recorded at fair value, defined as the exit price in the principal market in which the Company would transact, representing the amount that would be received to sell an asset or paid to transfer a liability in an orderly transaction between market participants. Level 2 securities are valued using quoted market prices for similar instruments, non-binding market prices that are corroborated by observable market data, or discounted cash flow techniques and include the Company’s investments in corporate debt securities and commercial paper. Financial liabilities that were measured or disclosed at fair value on a recurring basis, and were classified within the Level 3 designation, included the warrant liability and convertible notes prior to their conversion to equity upon the Company’s initial public offering in February 2014. None of the Company’s non-financial assets and liabilities are recorded at fair value on a non-recurring basis. No transfers between levels have occurred during the periods presented. | |||||||||||||||||
Cash equivalents measured at fair value as of March 31, 2015 and December 31, 2014 are all classified within Level 1. Below is a summary of other assets and liabilities measured at fair value (in thousands): | |||||||||||||||||
Fair Value Measurements at | |||||||||||||||||
Reporting Date Using | |||||||||||||||||
As of | Quoted Prices | Significant | Significant | ||||||||||||||
March 31, | in Active | Other | Unobservable | ||||||||||||||
2015 | Markets for | Observable | Inputs | ||||||||||||||
Identical | Inputs | (Level 3) | |||||||||||||||
Assets | (Level 2) | ||||||||||||||||
(Level 1) | |||||||||||||||||
Assets: | |||||||||||||||||
Corporate debt securities | $ | 20,570 | $ | — | $ | 20,570 | $ | — | |||||||||
Fair Value Measurements at | |||||||||||||||||
Reporting Date Using | |||||||||||||||||
As of | Quoted Prices | Significant | Significant | ||||||||||||||
December 31, | in Active | Other | Unobservable | ||||||||||||||
2014 | Markets for | Observable | Inputs | ||||||||||||||
Identical | Inputs | (Level 3) | |||||||||||||||
Assets | (Level 2) | ||||||||||||||||
(Level 1) | |||||||||||||||||
Assets: | |||||||||||||||||
Corporate debt securities | $ | 70,513 | $ | — | $ | 70,513 | $ | — | |||||||||
Commitments_and_Contingencies
Commitments and Contingencies | 3 Months Ended |
Mar. 31, 2015 | |
Commitments and Contingencies Disclosure [Abstract] | |
Commitments and Contingencies | 4. Commitments and Contingencies |
Sublicense Agreement and Amended and Restated License Agreement with AmpliPhi | |
Sublicense Agreement | |
In June 2012, the Company entered into a sublicense agreement (the AmpliPhi Sublicense) with AmpliPhi Biosciences Corporation (AmpliPhi), pursuant to which AmpliPhi sublicensed to the Company certain rights under a separate agreement which AmpliPhi entered into in 2009 with the Trustees of University of Pennsylvania (UPenn). Under the terms of the AmpliPhi Sublicense, the Company obtained an exclusive, worldwide sublicense from AmpliPhi under certain UPenn patents related to AAV1 vectors for the development, manufacture, use and sale of companion diagnostics to MYDICAR. In addition, the Company is required to use commercially reasonable efforts to meet certain developmental, regulatory and commercial milestones with respect to companion diagnostics under the agreement. The Company is currently in compliance with these milestone requirements. In consideration for the sublicense granted to the Company under the agreement, the Company paid to AmpliPhi a sublicense initiation fee of $310,000, and the Company is obligated to pay to AmpliPhi an annual sublicense maintenance fee of $310,000. The Company is also required to pay to AmpliPhi a low single-digit percentage royalty based on net sales of any companion diagnostic covered by a licensed patent sold by the Company, its affiliates or its sublicensees. The Company’s royalty obligations continue on a companion diagnostic-by-companion diagnostic and country-by-country basis until the expiration of the last-to-expire valid claim in a licensed patent covering the applicable companion diagnostic in such country. Finally, the Company is obligated to pay to AmpliPhi all royalty and milestone payments that become due and payable by AmpliPhi to UPenn under AmpliPhi’s agreement with UPenn as a result of the Company’s exercise of the sublicense granted under the Company’s agreement with AmpliPhi, including a low single-digit tiered percentage royalty on net sales of any companion diagnostic sold by the Company, its affiliates or its sublicensees, which royalty is separate from and in addition to the royalty payable to AmpliPhi described above, and up to an aggregate of $850,000 in potential milestone payments per product covered by the licensed patents. | |
The Company may unilaterally terminate the agreement upon 30 days’ written notice to AmpliPhi. Absent early termination, the agreement will automatically terminate upon the expiration of the last-to-expire licensed patent, which is expected to be in 2019. | |
No expense was recorded related to sublicense fees under the agreement in each of the three month periods ended March 31, 2015 and March 31, 2014. Through March 31, 2015, no milestone obligations were incurred under the agreement. | |
Amended and Restated License Agreement | |
The Company entered into an amended and restated license agreement with AmpliPhi concurrently with the AmpliPhi Sublicense that both amended the terms of the license agreement which the Company entered into with AmpliPhi in 2009 and terminated its manufacturing agreement with AmpliPhi which the Company entered into in 2009. Under the agreement, the Company obtained an exclusive, worldwide license under certain patents and know-how related to AmpliPhi’s AAV vector and manufacturing technology for the development, manufacture, use and sale of MYDICAR. In addition, the Company has agreed to use commercially reasonable efforts to meet certain diligence milestones with respect to the development and commercialization of at least one product covered by the UPenn patent rights licensed to AmpliPhi by UPenn under the Company’s agreement with UPenn. | |
The Company is currently in compliance with these milestone requirements. During the term of the agreement, the Company is not obligated to make annual license or maintenance payments, but is obligated to pay to AmpliPhi all royalty and milestone payments that become due and payable by AmpliPhi to UPenn under AmpliPhi’s agreement with UPenn as a result of the Company’s exercise of the sublicense granted under the Company’s agreement with AmpliPhi. This includes a low single-digit tiered percentage royalty on net sales of MYDICAR and any other product covered by the licensed patents sold by the Company, its affiliates or its sublicensees, and up to $850,000 in milestone payments upon the achievement of certain developmental and regulatory milestones related to MYDICAR and any other product covered by the licensed patents. Through March 31, 2015, no milestone obligations were incurred under the agreement. The agreement does not provide either party with termination rights and does not have a provision for expiration or automatic termination. | |
Exclusive Patent License with the Regents of the University of Minnesota | |
In May 2009, the Company entered into an exclusive patent license agreement with the Regents of the University of Minnesota (UMinn) under which it obtained an exclusive license to UMinn’s joint ownership interest in a patent application related to screening technology for isolation of small molecule modulators of SERCA enzymes. The agreement does not encompass a manufacturing agreement. | |
The Company has agreed to meet certain performance milestones under the agreement, the deadline for which may be extended at the Company’s request provided that the Company has used commercially reasonable efforts to achieve such milestones by the applicable deadlines. The Company has the first right to prosecute and maintain the applicable patent family. | |
The Company made an upfront payment to UMinn of $120,000. In addition, the Company is obligated to pay to UMinn an annual license fee of $120,000. The annual license fee will increase to $325,000 if the Company (1) undergoes a change of control, (2) assigns the agreement, any of its rights or obligations under the agreement or as joint ownership interest in the licensed technology, (3) receives a certain amount in license and sublicense revenues under the agreement, (4) files an investigational new drug application (IND), new drug application, biologic license application or orphan drug application (or a foreign equivalent of any such application) for a product covered by the licensed technology, or (5) enters into any agreement with a third party to market or use the licensed technology, subject to certain exceptions. | |
The Company may unilaterally terminate the agreement upon 90 days’ written notice to UMinn. UMinn may terminate the agreement upon 10 days’ written notice to the Company upon the Company’s insolvency or for its breach of the agreement if such breach remains uncured for 90 days after the Company receives notice of such breach, or 30 days in the case of a non-payment breach. Absent early termination, the agreement will automatically terminate upon the expiration of all active claims in any licensed patent or patent application, which is expected to occur no earlier than January 2030. | |
No expense was recorded related to license and annual maintenance fees under the agreement in each of the three month periods ended March 31, 2015 and March 31, 2014. Through March 31, 2015, no milestone obligations were incurred under the agreement. | |
Material Transfer and Exclusivity Agreement | |
In February 2014, the Company and Les Laboratoires Servier (Servier) entered into a material transfer and exclusivity agreement, pursuant to which the Company agreed to transfer to Servier samples of certain proprietary compounds from the Company’s small molecule SERCA2b modulator program and granted to Servier a non-exclusive, non-sublicensable, royalty-free license to conduct certain studies of the samples for the purpose of evaluating Servier’s interest in negotiating a potential license and research collaboration agreement with the Company relating to small molecule SERCA2b modulators (Compounds), for the treatment of type 2 diabetes and other metabolic diseases. Although the evaluation period under this Agreement has expired, the Company is in the process of completing certain pre-clinical studies of these compounds in coordination with Servier and Servier is continuing to evaluate its potential interest in this program. | |
License Agreement with Enterprise | |
On July 18, 2014, the Company and Enterprise Partners Management, LLC (Enterprise), an affiliate of Enterprise Partners Venture Capital, entered into an Assignment and License Agreement (the Enterprise License Agreement), pursuant to which Enterprise granted to the Company an exclusive, worldwide license and the assignment of patents held by Enterprise relating to certain gene therapy applications of the membrane-bound form of the Stem Cell Factor gene (mSCF) for treatment of cardiac ischemia. The Company has the right to grant sublicenses to third parties under the Enterprise License Agreement. Entities affiliated with Enterprise beneficially owned more than 10% of Celladon’s stock as of the date the Enterprise License Agreement was executed. | |
In consideration for the rights granted to the Company under the Enterprise License Agreement, the Company paid an upfront fee to Enterprise of $160,000. The Company is also obligated to pay to Enterprise a milestone payment in the amount of $1,000,000 upon the grant to the Company, a Company affiliate or a Company sublicensee of the first regulatory approval in the United States of a product that is covered by the licensed patents. In addition, the Company is required to pay to Enterprise a 2% royalty on net sales of products sold by the Company, Company affiliates and Company sublicensees that are covered by the licensed patents. The Company’s royalty obligations continue on a product-by-product and country-by-country basis until the expiration of the last-to-expire valid claim in the licensed patents covering a licensed product in such country. | |
The Company may unilaterally terminate the Enterprise License Agreement upon written notice to Enterprise. Enterprise may terminate the agreement in the event of the Company’s material breach of the Enterprise License Agreement if such breach remains uncured for 90 days following receipt of written notice of such breach. Absent early termination, the Enterprise License Agreement will automatically terminate upon the expiration of the last-to-expire of the licensed patents containing a valid claim. | |
Other License Agreements | |
The Company has entered into various license agreements pursuant to which the Company acquired certain intellectual property. Pursuant to each agreement the Company paid a license fee and reimbursed historical patent costs. Additionally, under each agreement, the Company may be required to pay annual maintenance fees, royalties, milestone payments and sublicensing fees. Each of the license agreements is generally cancelable by the Company, given appropriate prior written notice. Minimum annual payments to maintain these cancelable licenses total an aggregate of approximately $0.2 million and potential future milestone payments total an aggregate of approximately $3.3 million. The Company has recorded research and development expense related to license and annual maintenance fees under the agreements of $0.1 million for each of the three month periods ended March 31, 2015 and March 31, 2014. | |
Through March 31, 2015, the Company has recorded research and development expense of $0.1 million related to milestone obligations incurred under the agreements. | |
Leases | |
The Company leases office space in San Diego, California under long-term operating leases that expire in October 2017 and September 2021. In March 2015, the Company entered into a short-term lease for approximately 7,000 square feet of office space in Seattle, Washington that expires in June 2016. The Company also has short-term leases for satellite office space in Seattle, Washington and housing accommodation in San Diego that expire in 2015. Rent expense for the three months ended March 31, 2015 and March 31, 2014 was $0.1 million and $21,000, respectively. Future minimum payments under the long-term operating leases net of contractual sublease payments total $3.0 million. |
Stockholders_Equity
Stockholders' Equity | 3 Months Ended | ||||||||
Mar. 31, 2015 | |||||||||
Equity [Abstract] | |||||||||
Stockholders' Equity | 5. Stockholders’ Equity | ||||||||
Common Stock Warrants | |||||||||
The following table summarizes the fully exercisable warrants outstanding for the purchase of common stock as of March 31, 2015 and December 31, 2014: | |||||||||
March 31, | December 31, | Exercise | Expiration | ||||||
2015 | 2014 | Price | Date | ||||||
152,735 | 206,340 | $ 5.61 | October 2018 | ||||||
Stock Options | |||||||||
Options granted under the Company’s equity incentive plans generally expire no more than ten years from the date of grant and generally vest and become exercisable over a period not to exceed four years, as determined by the Company’s board of directors. Recipients of stock options are eligible to purchase shares of the Company’s common stock at an exercise price equal to no less than the estimated fair market value of such stock on the date of grant. The Company has also granted inducement stock options outside an equity incentive plan that are subject to the terms and conditions of the Company’s 2013 Equity Incentive Plan. | |||||||||
Prior Plans | |||||||||
In December 2001, the Company adopted its 2001 Stock Option Plan (the 2001 Plan) and in January 2012 adopted its 2012 Equity Incentive Plan (the 2012 Plan, and together with the 2001 Plan, the Prior Plans). The Prior Plans have terminated and no further shares may be granted under the Prior Plans. | |||||||||
2013 Equity Incentive Plan | |||||||||
The 2013 Equity Incentive Plan became effective in February 2014. Under the 2013 Equity Incentive Plan, the Company may grant stock options, stock appreciation rights, restricted stock, restricted stock units (RSUs), performance-based stock awards and other awards to individuals who are then employees, officers, non-employee directors or consultants of the Company and its affiliates. Additionally, the 2013 Equity Incentive Plan provides for the grant of performance cash awards. The number of shares of common stock reserved for issuance under the 2013 Equity Incentive Plan will automatically increase on January 1 of each year continuing through and including January 1, 2023 by 5% of the total number of shares of the Company’s capital stock outstanding on December 31 of the preceding calendar year, or a lesser number of shares determined by the Company’s board of directors. | |||||||||
A summary of the Company’s stock option and RSU activity is as follows: | |||||||||
Options and RSUs | |||||||||
Outstanding at December 31, 2014 | 2,408,634 | ||||||||
Granted | 1,302,750 | ||||||||
Exercised | (296,287 | ) | |||||||
Cancelled | (15,000 | ) | |||||||
Outstanding at March 31, 2015 | 3,400,097 | ||||||||
2013 Employee Stock Purchase Plan | |||||||||
The 2013 Equity Stock Purchase Plan (ESPP) became effective in January 2014. The number of shares of common stock reserved for issuance will automatically increase on January 1 of each calendar year through January 1, 2023 by the least of (1) 1% of the total number of shares of the Company’s common stock outstanding on December 31 of the preceding calendar year, (2) 384,307 shares, or (3) a number determined by the Company’s board of directors that is less than (1) and (2). | |||||||||
Stock-Based Compensation Expense | |||||||||
The allocation of stock-based compensation for all equity awards is as follows (in thousands): | |||||||||
Three Months | |||||||||
Ended | |||||||||
March 31, | |||||||||
2015 | 2014 | ||||||||
Research and development | $ | 909 | $ | 343 | |||||
General and administrative | 1,194 | 176 | |||||||
$ | 2,103 | $ | 519 | ||||||
As of March 31, 2015 the unrecognized compensation cost related to outstanding employee options was $23.4 million and is expected to be recognized as expense over approximately 3.5 years. |
LongTerm_Obligations
Long-Term Obligations | 3 Months Ended | ||||||||
Mar. 31, 2015 | |||||||||
Debt Disclosure [Abstract] | |||||||||
Long-Term Obligations | 6. Long-Term Obligations | ||||||||
Hercules Loan Agreement | |||||||||
On July 31, 2014, the Company entered into a Loan and Security Agreement (the Loan Agreement) with Hercules Technology III, L.P. and Hercules Technology Growth Capital, Inc. (as agent and as a lender, and together with Hercules Technology III, L.P., the Lenders) under which up to $25.0 million was available for the Company to borrow in two tranches (the Loan). | |||||||||
The Company borrowed the first tranche of $10.0 million on August 1, 2014. The second tranche of up to $15.0 million was available to be drawn through June 30, 2015, but only if the Company provided the Lenders with notice that data from the Company’s Phase 2b clinical trial for MYDICAR supported the continued development of MYDICAR for its Breakthrough Therapy designation to either a Phase 3 clinical trial or for registration for approval, as reasonably determined by the Company’s senior management and board of directors (the Milestone). In April 2015, the Company’s senior management and board of directors determined that the Company did not achieve the Milestone (see Note 7). Accordingly, the Company cannot draw down the second tranche of $15.0 million. Pursuant to the terms of the Loan Agreement, the Company is required to begin repaying the Loan principal on August 1, 2015, in 30 equal monthly installments of principal and interest. | |||||||||
The Loan accrues interest at a rate equal to the greater of either (i) 8.25% plus the prime rate as reported from time to time in The Wall Street Journal minus 5.25%, and (ii) 8.25%. Payments under the Loan Agreement are interest only until August 1, 2015 (the Amortization Date) followed by equal monthly payments of principal and interest, through the scheduled maturity date on February 1, 2018 (the Loan Maturity Date). In addition, a final payment equal to $1,750,000 will be due at such time as the Loan is prepaid or becomes due and payable in full as specified in the Loan Agreement. The Company’s obligations under the Loan Agreement are secured by a security interest in substantially all of its assets, excluding its intellectual property but including the proceeds from the sale, licensing or disposition of its intellectual property. The Company’s intellectual property is also subject to customary negative covenants. | |||||||||
If the Company prepays the Loan prior to maturity, it will pay the Lenders a prepayment charge, based on a percentage of the then outstanding principal balance, equal to 1.5% if the prepayment occurs prior to the Amortization Date. | |||||||||
Subject to certain conditions and limitations set forth in the Loan Agreement, including ownership limitations of the Lenders, the Company has the right to convert up to $3.0 million of scheduled principal installments of the Loan into shares of the Company’s common stock, provided such shares must be freely tradable. The number of shares of common stock that would be issued upon conversion would be equal to the number determined by dividing (x) the principal amount to be paid in shares of common stock by (y) $16.33. | |||||||||
The Loan Agreement includes customary representations, warranties and covenants (affirmative and negative) of the Company, including restrictive covenants that limit the Company’s ability to: incur additional indebtedness; encumber the collateral securing the Loan; acquire, own or make investments; repurchase or redeem stock or other equity securities; declare or pay any cash dividend or make a cash distribution on any class of stock or other equity interest; transfer a material portion of the Company’s assets; acquire other businesses; and merge or consolidate with or into any other business organization. The Loan Agreement does not however include any financial maintenance covenants. The Loan Agreement also includes standard events of default, including payment defaults, breaches of covenants following any applicable cure period, a material impairment in the perfection or priority of the Lenders’ security interest or in the value of the collateral, and events relating to bankruptcy or insolvency. Upon the occurrence of an event of default, a default interest rate of an additional 5% may be applied to the outstanding Loan, and the Lenders may declare all outstanding obligations immediately due and payable and take such other actions as are set forth in the Loan Agreement. | |||||||||
Capital Lease | |||||||||
In 2014 the Company entered into a capital lease arrangement for office equipment in the Company’s San Diego, California office. The Company is obligated to make 60 payments of approximately $600. | |||||||||
Contractual Payments and Carrying-Value Reconciliation | |||||||||
The following table provides a reconciliation of our future contractual principal and final fee payments on our debt and capital lease obligations to the reported carrying value (in thousands): | |||||||||
March 31, | December 31, | ||||||||
2015 | 2014 | ||||||||
Total loan debt and capital lease obligations | $ | 11,762 | $ | 11,762 | |||||
Less: Debt discount | (1,381 | ) | (1,659 | ) | |||||
Total carrying value: | 10,381 | 10,103 | |||||||
Less: Carrying value of current portion of long-term obligations | (1,671 | ) | (1 | ) | |||||
Carrying value of long-term obligations, less current portion | $ | 8,710 | $ | 10,102 | |||||
Subsequent_Events
Subsequent Events | 3 Months Ended |
Mar. 31, 2015 | |
Subsequent Events [Abstract] | |
Subsequent Events | 7. Subsequent Events |
Results of MYDICAR Phase 2b Trial (CUPID 2) | |
On April 26, 2015, the Company announced that its Phase 2b CUPID 2 trial did not meet its primary and secondary endpoints. CUPID 2 is a randomized, double-blind, placebo-controlled, multinational trial evaluating a single, one-time, intracoronary infusion of the cardiovascular gene therapy agent MYDICAR(R) (AAV1/SERCA2a) versus placebo added to a maximal, optimized heart failure drug and device regimen. In the study, the primary endpoint comparison of MYDICAR to placebo resulted in a hazard ratio in the MYDICAR group of 0.93; 95% confidence interval (CI), 0.53 to 1.65; p=81, defined as heart failure-related hospitalizations or ambulatory treatment for worsening heart failure. The secondary endpoint comparison of MYDICAR to placebo, defined as all-cause death, need for a mechanical circulatory support device, or heart transplant, likewise failed to show a significant treatment effect. The efficacy endpoint analyses were performed on the (n$3) modified intent to treat population (mITT), which excludes clinical events that occurred in patients who did not receive MYDICAR or placebo, or which occurred prior to dosing. All other exploratory efficacy endpoints (improvement in New York Heart Association classification, 6 Minute Walk Test, Quality of Life, and NT-proBNP) were also inconsistent with a treatment effect. No safety issues were noted. More extensive review of the data is ongoing at this time. | |
Reduction in Force; Retention Program | |
In light of the CUPID 2 results, on April 26, 2015 the Company’s board of directors approved an approximately 50% reduction of the Company’s current full-time workforce of 34 employees in order to reduce operating expenses and conserve cash resources. The Company expects that a majority of employees included in this workforce reduction will be separated from the Company during the second quarter of 2015, with the remainder expected to be separated during the third quarter of 2015. The Company has also committed to retention payments payable to certain key employees if such employees remain with the Company until December 31, 2015 or are terminated by the Company without cause prior to such date. The Company estimates that it will incur aggregate cash charges of up to approximately $2.4 million associated with the workforce reduction and retention payments during 2015 including approximately $1.0 million in one-time severance payments, approximately $0.1 million in continuation of benefits, approximately $24,000 in outplacement service benefits and up to approximately $1.3 million by December 31, 2015 in connection with retention payments. | |
Termination of Supply Agreement | |
Effective April 29, 2015, the Company terminated the Development, Manufacturing and Supply Agreement by and between the Company and Novasep, Inc. (Novasep) dated March 20, 2015 (Novasep Agreement) pursuant to the Company’s post CUPID 2 data termination right, after concluding that the recently un-blinded data from CUPID 2 was such that the Company does not require production of MYDICAR drug substance at Novasep’s facility. The Company made payments to Novasep totaling €3.1 million through March 31, 2015 prior to terminating the Novasep Agreement and is scheduled to pay the remaining €1.7 million due in the second quarter of 2015. |
Basis_of_Presentation_Organiza1
Basis of Presentation, Organization and Summary of Significant Accounting Policies (Policies) | 3 Months Ended | ||||||||||||||||||||
Mar. 31, 2015 | |||||||||||||||||||||
Accounting Policies [Abstract] | |||||||||||||||||||||
Basis of Presentation | Basis of Presentation | ||||||||||||||||||||
The accompanying unaudited consolidated financial statements of Celladon Corporation (Celladon or the Company) should be read in conjunction with the audited financial statements and notes thereto as of and for the year ended December 31, 2014 included in the Company’s Annual Report on Form 10-K (Annual Report) filed with the Securities and Exchange Commission (SEC). The accompanying financial statements have been prepared in accordance with U.S. generally accepted accounting principles (GAAP) for interim financial information and in accordance with the instructions to Form 10-Q and Article 10 of Regulation S-X. Accordingly, since they are interim statements, the accompanying financial statements do not include all of the information and notes required by GAAP for complete financial statements. In the opinion of management, the accompanying financial statements reflect all adjustments (consisting of normal recurring adjustments) that are necessary for a fair statement of the financial position, results of operations and cash flows for the interim periods presented. Interim results are not necessarily indicative of results for a full year. The preparation of the Company’s consolidated financial statements requires it to make estimates and assumptions that impact the reported amounts of assets, liabilities and expenses and the disclosure of contingent assets and liabilities in the Company’s consolidated financial statements and accompanying notes. The most significant estimates in the Company’s consolidated financial statements relate to the fair value of equity awards and clinical trial expense accruals. Although these estimates are based on the Company’s knowledge of current events and actions it may undertake in the future, actual results may ultimately materially differ from these estimates and assumptions. | |||||||||||||||||||||
Organization | Organization | ||||||||||||||||||||
Celladon was incorporated in California on December 21, 2000 (inception) and reincorporated in Delaware in April 2012. The Company is a clinical-stage biotechnology with industry-leading expertise in the development of cardiovascular gene therapy. | |||||||||||||||||||||
As of March 31, 2015, the Company has devoted substantially all of its efforts to product development, raising capital and building infrastructure and has not generated revenues from its planned principal operations. | |||||||||||||||||||||
Principles of Consolidation | Principles of Consolidation | ||||||||||||||||||||
The financial statements of the Company’s former subsidiary Celladon Europe B.V. (Celladon Europe) were consolidated with those of the Company through Celladon Europe’s dissolution on December 30, 2014. All intercompany transactions and balances were eliminated in consolidation. | |||||||||||||||||||||
Investment Securities | Investment Securities | ||||||||||||||||||||
Investment securities primarily consist of investment grade corporate debt securities. The Company classifies all investment securities as available-for-sale. Investments with maturity dates greater than 12 months from the end of each reporting period are classified as long-term. Investment securities are carried at fair value, with the unrealized gains and losses reported as a component of other comprehensive income (loss) in stockholders’ equity (deficit) until realized. Realized gains and losses from the sale of investment securities, if any, are determined on a specific identification basis. A decline in the market value of any investment security below cost that is determined to be other than temporary will result in an impairment charge to earnings and a new cost basis for the security is established. No such impairment charges were recorded for any period presented. As of March 31, 2015 and December 31, 2014, none of the investment securities have been in an unrealized loss position for more than 12 months. Premiums and discounts are amortized or accreted over the life of the related security as an adjustment to yield using the straight-line method and are included in interest income. Interest income is recognized when earned. | |||||||||||||||||||||
The following table sets forth the composition of the Company’s investment securities (in thousands): | |||||||||||||||||||||
Unrealized | |||||||||||||||||||||
As of March 31, 2015 | Maturity in Years | Amortized | Gains | Losses | Fair | ||||||||||||||||
Cost | Value | ||||||||||||||||||||
Corporate debt securities | Less than 1 year | $ | 20,571 | $ | — | $ | (1 | ) | $ | 20,570 | |||||||||||
Unrealized | |||||||||||||||||||||
As of December 31, 2014 | Maturity in Years | Amortized | Gains | Losses | Fair | ||||||||||||||||
Cost | Value | ||||||||||||||||||||
Corporate debt securities | Less than 1 year | $ | 70,521 | $ | — | $ | (8 | ) | $ | 70,513 | |||||||||||
Net Loss Per Share Attributable to Common Stockholders | Net Loss Per Share Attributable to Common Stockholders | ||||||||||||||||||||
Basic and diluted net loss per common share is calculated by dividing net loss applicable to common stockholders by the weighted-average number of common shares outstanding during the period, without consideration for common stock equivalents. Potentially dilutive shares, which include convertible preferred stock and rights to acquire convertible preferred stock (non-controlling interest), warrants for the purchase of common stock and options outstanding under the Company’s equity incentive plans, are considered to be common stock equivalents and are only included in the calculation of diluted net loss per share when their effect is dilutive. | |||||||||||||||||||||
Potentially dilutive securities not included in the calculation of diluted net loss per share attributable to common stockholders because to do so would be anti-dilutive are as follows (in common stock equivalent shares): | |||||||||||||||||||||
Three Months Ended | |||||||||||||||||||||
March 31, | |||||||||||||||||||||
2015 | 2014 | ||||||||||||||||||||
Warrants for common stock | 152,735 | 231,821 | |||||||||||||||||||
Common stock options and restricted stock units | 3,400,097 | 2,060,890 | |||||||||||||||||||
3,552,832 | 2,292,711 | ||||||||||||||||||||
Recent Accounting Pronouncements | Recent Accounting Pronouncements | ||||||||||||||||||||
In April 2015, the FASB issued ASU No. 2015-03, Interest - Imputation of Interest (Subtopic 835-30): Simplifying the Presentation of Debt Issuance Costs. The amendments in this ASU require that debt issuance costs related to a recognized debt liability be presented in the balance sheet as a direct deduction from the carrying amount of that debt liability, consistent with debt discounts. The amendments in this ASU are effective for financial statements issued for fiscal years beginning after December 15, 2015, and interim periods within those fiscal years. Early adoption of the amendments is permitted. The new guidance shall be applied on a retrospective basis, wherein the balance sheet of each individual period presented should be adjusted to reflect the period-specific effects of applying the new guidance. The Company is currently evaluating the impact of the adoption of this standard on its consolidated financial statements. |
Basis_of_Presentation_Organiza2
Basis of Presentation, Organization and Summary of Significant Accounting Policies (Tables) | 3 Months Ended | ||||||||||||||||||||
Mar. 31, 2015 | |||||||||||||||||||||
Accounting Policies [Abstract] | |||||||||||||||||||||
Composition of Investment Securities | The following table sets forth the composition of the Company’s investment securities (in thousands): | ||||||||||||||||||||
Unrealized | |||||||||||||||||||||
As of March 31, 2015 | Maturity in Years | Amortized | Gains | Losses | Fair | ||||||||||||||||
Cost | Value | ||||||||||||||||||||
Corporate debt securities | Less than 1 year | $ | 20,571 | $ | — | $ | (1 | ) | $ | 20,570 | |||||||||||
Unrealized | |||||||||||||||||||||
As of December 31, 2014 | Maturity in Years | Amortized | Gains | Losses | Fair | ||||||||||||||||
Cost | Value | ||||||||||||||||||||
Corporate debt securities | Less than 1 year | $ | 70,521 | $ | — | $ | (8 | ) | $ | 70,513 | |||||||||||
Potentially Dilutive Securities Not Included in Calculation of Diluted Net Loss Per Share Attributable to Common Stockholders | Potentially dilutive securities not included in the calculation of diluted net loss per share attributable to common stockholders because to do so would be anti-dilutive are as follows (in common stock equivalent shares): | ||||||||||||||||||||
Three Months Ended | |||||||||||||||||||||
March 31, | |||||||||||||||||||||
2015 | 2014 | ||||||||||||||||||||
Warrants for common stock | 152,735 | 231,821 | |||||||||||||||||||
Common stock options and restricted stock units | 3,400,097 | 2,060,890 | |||||||||||||||||||
3,552,832 | 2,292,711 | ||||||||||||||||||||
Balance_Sheet_Details_Tables
Balance Sheet Details (Tables) | 3 Months Ended | ||||||||
Mar. 31, 2015 | |||||||||
Organization, Consolidation and Presentation of Financial Statements [Abstract] | |||||||||
Summary of Prepaid Expenses and Other Assets | Prepaid expenses and other assets consist of the following (in thousands): | ||||||||
March 31, | December 31, | ||||||||
2015 | 2014 | ||||||||
Prepaid expenses | 1,443 | 756 | |||||||
Commercial manufacturing costs (1) | — | 1,751 | |||||||
Other receivables | 158 | 628 | |||||||
Debt issue costs, current | 72 | — | |||||||
$ | 1,673 | $ | 3,135 | ||||||
-1 | The commercial manufacturing costs consisted mainly of design and engineering services for commercial drug manufacturing capabilities. The Company determined that it was probable that it would not complete the commercial manufacturing project in light of the negative CUPID 2 data. The Company therefore recorded the costs accumulated as of December 31, 2014 and activity in the first quarter of 2015 as a period expense in the consolidated financial statements in the three month period ending March 31, 2015. | ||||||||
Summary of Property and Equipment | Property and equipment consist of the following (in thousands): | ||||||||
March 31, | December 31, | ||||||||
2015 | 2014 | ||||||||
Office furniture and other equipment | $ | 905 | $ | 881 | |||||
Leasehold improvements | 247 | 246 | |||||||
Construction in progress | 81 | — | |||||||
Accumulated depreciation | (440 | ) | (364 | ) | |||||
$ | 793 | $ | 763 | ||||||
Summary of Accounts Payable and Accrued Expenses | Accounts payable and accrued expenses consist of the following (in thousands): | ||||||||
March 31, | December 31, | ||||||||
2015 | 2014 | ||||||||
Accounts payable | $ | 2,790 | $ | 3,293 | |||||
Accrued compensation | 361 | 1,909 | |||||||
Accrued other | 587 | 596 | |||||||
Current portion of deferred rent | 8 | 5 | |||||||
$ | 3,746 | $ | 5,803 | ||||||
Fair_Value_Measurements_Tables
Fair Value Measurements (Tables) | 3 Months Ended | ||||||||||||||||
Mar. 31, 2015 | |||||||||||||||||
Fair Value Disclosures [Abstract] | |||||||||||||||||
Summary of Other Assets and Liabilities Measured at Fair Value | Cash equivalents measured at fair value as of March 31, 2015 and December 31, 2014 are all classified within Level 1. Below is a summary of other assets and liabilities measured at fair value (in thousands): | ||||||||||||||||
Fair Value Measurements at | |||||||||||||||||
Reporting Date Using | |||||||||||||||||
As of | Quoted Prices | Significant | Significant | ||||||||||||||
March 31, | in Active | Other | Unobservable | ||||||||||||||
2015 | Markets for | Observable | Inputs | ||||||||||||||
Identical | Inputs | (Level 3) | |||||||||||||||
Assets | (Level 2) | ||||||||||||||||
(Level 1) | |||||||||||||||||
Assets: | |||||||||||||||||
Corporate debt securities | $ | 20,570 | $ | — | $ | 20,570 | $ | — | |||||||||
Fair Value Measurements at | |||||||||||||||||
Reporting Date Using | |||||||||||||||||
As of | Quoted Prices | Significant | Significant | ||||||||||||||
December 31, | in Active | Other | Unobservable | ||||||||||||||
2014 | Markets for | Observable | Inputs | ||||||||||||||
Identical | Inputs | (Level 3) | |||||||||||||||
Assets | (Level 2) | ||||||||||||||||
(Level 1) | |||||||||||||||||
Assets: | |||||||||||||||||
Corporate debt securities | $ | 70,513 | $ | — | $ | 70,513 | $ | — | |||||||||
Stockholders_Equity_Tables
Stockholders' Equity (Tables) | 3 Months Ended | ||||||||
Mar. 31, 2015 | |||||||||
Equity [Abstract] | |||||||||
Summary of Exercisable Warrants Outstanding for Purchase of Common Stock | The following table summarizes the fully exercisable warrants outstanding for the purchase of common stock as of March 31, 2015 and December 31, 2014: | ||||||||
March 31, | December 31, | Exercise | Expiration | ||||||
2015 | 2014 | Price | Date | ||||||
152,735 | 206,340 | $ 5.61 | October 2018 | ||||||
Summary of Company's Stock Option and RSU Activity | A summary of the Company’s stock option and RSU activity is as follows: | ||||||||
Options and RSUs | |||||||||
Outstanding at December 31, 2014 | 2,408,634 | ||||||||
Granted | 1,302,750 | ||||||||
Exercised | (296,287 | ) | |||||||
Cancelled | (15,000 | ) | |||||||
Outstanding at March 31, 2015 | 3,400,097 | ||||||||
Schedule of Allocation of Stock-based Compensation for Equity Awards | The allocation of stock-based compensation for all equity awards is as follows (in thousands): | ||||||||
Three Months | |||||||||
Ended | |||||||||
March 31, | |||||||||
2015 | 2014 | ||||||||
Research and development | $ | 909 | $ | 343 | |||||
General and administrative | 1,194 | 176 | |||||||
$ | 2,103 | $ | 519 | ||||||
LongTerm_Obligations_Tables
Long-Term Obligations (Tables) | 3 Months Ended | ||||||||
Mar. 31, 2015 | |||||||||
Debt Disclosure [Abstract] | |||||||||
Summary of Reconciliation of Future Contractual Principal and Final Fee Payments on Debt and Capital Lease Obligations | The following table provides a reconciliation of our future contractual principal and final fee payments on our debt and capital lease obligations to the reported carrying value (in thousands): | ||||||||
March 31, | December 31, | ||||||||
2015 | 2014 | ||||||||
Total loan debt and capital lease obligations | $ | 11,762 | $ | 11,762 | |||||
Less: Debt discount | (1,381 | ) | (1,659 | ) | |||||
Total carrying value: | 10,381 | 10,103 | |||||||
Less: Carrying value of current portion of long-term obligations | (1,671 | ) | (1 | ) | |||||
Carrying value of long-term obligations, less current portion | $ | 8,710 | $ | 10,102 | |||||
Basis_of_Presentation_Organiza3
Basis of Presentation, Organization and Summary of Significant Accounting Policies - Additional Information (Detail) (USD $) | 3 Months Ended | 12 Months Ended |
Mar. 31, 2015 | Dec. 31, 2014 | |
Organization, Consolidation and Presentation of Financial Statements [Abstract] | ||
Impairment charges on investment securities | $0 | |
Investment securities, unrealized loss position for more than 12 months | $0 | $0 |
Basis_of_Presentation_Organiza4
Basis of Presentation, Organization and Summary of Significant Accounting Policies - Composition of Investment Securities (Detail) (USD $) | 3 Months Ended | 12 Months Ended |
In Thousands, unless otherwise specified | Mar. 31, 2015 | Dec. 31, 2014 |
Schedule of Available-for-sale Securities [Line Items] | ||
Fair Value | $20,570 | $70,513 |
Corporate Debt Securities [Member] | ||
Schedule of Available-for-sale Securities [Line Items] | ||
Maturity in Years | Less than 1 year | Less than 1 year |
Amortized Cost | 20,571 | 70,521 |
Unrealized Gains | 0 | 0 |
Unrealized Losses | -1 | -8 |
Fair Value | $20,570 | $70,513 |
Basis_of_Presentation_Organiza5
Basis of Presentation, Organization and Summary of Significant Accounting Policies - Potentially Dilutive Securities Not Included in Calculation of Diluted Net Loss Per Share Attributable to Common Stockholders (Detail) | 3 Months Ended | |
Mar. 31, 2015 | Mar. 31, 2014 | |
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] | ||
Anti-dilutive securities | 3,552,832 | 2,292,711 |
Warrants for Common Stock [Member] | ||
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] | ||
Anti-dilutive securities | 152,735 | 231,821 |
Common Stock Options And Restricted Stock Units [Member] | ||
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] | ||
Anti-dilutive securities | 3,400,097 | 2,060,890 |
Balance_Sheet_Details_Summary_
Balance Sheet Details - Summary of Prepaid Expenses and Other Assets (Detail) (USD $) | Mar. 31, 2015 | Dec. 31, 2014 |
In Thousands, unless otherwise specified | ||
Prepaid Expense and Other Assets, Current [Abstract] | ||
Prepaid expenses | $1,443 | $756 |
Commercial manufacturing costs | 1,751 | |
Other receivables | 158 | 628 |
Debt issue costs, current | 72 | |
Prepaid expenses and other assets | $1,673 | $3,135 |
Balance_Sheet_Details_Summary_1
Balance Sheet Details - Summary of Property and Equipment (Detail) (USD $) | Mar. 31, 2015 | Dec. 31, 2014 |
In Thousands, unless otherwise specified | ||
Property, Plant and Equipment [Line Items] | ||
Property and equipment, accumulated depreciation | ($440) | ($364) |
Property and equipment, net | 793 | 763 |
Office Furniture and Other Equipment [Member] | ||
Property, Plant and Equipment [Line Items] | ||
Property and equipment, gross | 905 | 881 |
Leasehold Improvements [Member] | ||
Property, Plant and Equipment [Line Items] | ||
Property and equipment, gross | 247 | 246 |
Construction in Progress [Member] | ||
Property, Plant and Equipment [Line Items] | ||
Property and equipment, gross | $81 |
Balance_Sheet_Details_Summary_2
Balance Sheet Details - Summary of Accounts Payable and Accrued Expenses (Detail) (USD $) | Mar. 31, 2015 | Dec. 31, 2014 |
In Thousands, unless otherwise specified | ||
Statement of Financial Position [Abstract] | ||
Accounts payable | $2,790 | $3,293 |
Accrued compensation | 361 | 1,909 |
Accrued other | 587 | 596 |
Current portion of deferred rent | 8 | 5 |
Accounts payable and accrued expenses | $3,746 | $5,803 |
Fair_Value_Measurements_Summar
Fair Value Measurements - Summary of Assets and Liabilities Measured at Fair Value (Detail) (Corporate Debt Securities [Member], USD $) | Mar. 31, 2015 | Dec. 31, 2014 |
In Thousands, unless otherwise specified | ||
Assets: | ||
Assets, Fair Value | $20,570 | $70,513 |
Level 2 [Member] | ||
Assets: | ||
Assets, Fair Value | $20,570 | $70,513 |
Commitments_and_Contingencies_
Commitments and Contingencies - Additional Information (Detail) (USD $) | 3 Months Ended | 1 Months Ended | |||
Mar. 31, 2015 | Mar. 31, 2014 | Mar. 31, 2015 | Jun. 30, 2012 | 31-May-09 | |
sqft | |||||
Other Commitments [Line Items] | |||||
Research and development expense | $11,518,000 | $5,218,000 | |||
Rent expense | 100,000 | 21,000 | |||
Future minimum payments under long-term operating leases | 3,000,000 | 3,000,000 | |||
Lease Agreements One [Member] | |||||
Other Commitments [Line Items] | |||||
Long-term operating lease expiry period | 2017-10 | ||||
Lease Agreements Two [Member] | |||||
Other Commitments [Line Items] | |||||
Long-term operating lease expiry period | 2021-09 | ||||
Lease Agreements Three [Member] | |||||
Other Commitments [Line Items] | |||||
Long-term operating lease expiry period | 2016-06 | ||||
Area of office space | 7,000 | ||||
Lease Agreements Four [Member] | |||||
Other Commitments [Line Items] | |||||
Operating lease expiry year | 2015 | ||||
Licensing Agreements [Member] | AmpliPhi Sublicense Transaction [Member] | |||||
Other Commitments [Line Items] | |||||
Sublicense fees | 0 | 0 | 310,000 | ||
Aggregate potential milestone payments | 850,000 | ||||
Annual sublicense maintenance fee payable | 310,000 | ||||
Notice period given by company for termination of license agreement | 30 days | ||||
License agreement expiration year | 2019 | ||||
Milestone obligations incurred | 0 | ||||
Licensing Agreements [Member] | AmpliPhi Amended Sublicense Transaction [Member] | |||||
Other Commitments [Line Items] | |||||
Milestone obligations incurred | 0 | ||||
Licensing Agreements [Member] | Regents of University of Minnesota Patent Transaction [Member] | |||||
Other Commitments [Line Items] | |||||
Notice period given by company for termination of license agreement | 90 days | ||||
Milestone obligations incurred | 0 | ||||
Upfront payment | 120,000 | ||||
Annual license fee | 120,000 | ||||
Estimated future annual license fee | 325,000 | ||||
License agreement termination, description | The Company may unilaterally terminate the agreement upon 90 daysb written notice to UMinn. UMinn may terminate the agreement upon 10 daysb written notice to the Company upon the Companybs insolvency or for its breach of the agreement if such breach remains uncured for 90 days after the Company receives notice of such breach, or 30 days in the case of a non-payment breach. Absent early termination, the agreement will automatically terminate upon the expiration of all active claims in any licensed patent or patent application, which is expected to occur no earlier than January 2030. | ||||
Patent expiration period | 2030-01 | ||||
License and annual maintenance fees | 0 | 0 | |||
Licensing Agreements [Member] | Regents of University of Minnesota Patent Transaction [Member] | Insolvency [Member] | |||||
Other Commitments [Line Items] | |||||
Notice period given to company for termination of license agreement company | 10 days | ||||
Licensing Agreements [Member] | Regents of University of Minnesota Patent Transaction [Member] | Breach of Agreement [Member] | |||||
Other Commitments [Line Items] | |||||
Notice period given to company for termination of license agreement company | 90 days | ||||
Licensing Agreements [Member] | Regents of University of Minnesota Patent Transaction [Member] | Non-payment Breach [Member] | |||||
Other Commitments [Line Items] | |||||
Notice period given to company for termination of license agreement company | 30 days | ||||
Licensing Agreements [Member] | Enterprise Transaction [Member] | |||||
Other Commitments [Line Items] | |||||
Notice period given by company for termination of license agreement | 90 days | ||||
Upfront payment | 160,000 | ||||
License agreement termination, description | Enterprise may terminate the agreement in the event of the Company's material breach of the Enterprise License Agreement if such breach remains uncured for 90 days following receipt of written notice of such breach. | ||||
Ownership interest, percentage | 10.00% | 10.00% | |||
Aggregate potential future milestone payments | 1,000,000 | 1,000,000 | |||
Royalty on net sales | 2.00% | ||||
Licensing Agreements [Member] | Other Transaction [Member] | |||||
Other Commitments [Line Items] | |||||
Aggregate potential future milestone payments | 3,300,000 | 3,300,000 | |||
Aggregate minimum annual payments to maintain cancelable licenses | 200,000 | ||||
Research and development expense | $100,000 | $100,000 |
Stockholders_Equity_Summary_of
Stockholders' Equity - Summary of Exercisable Warrants Outstanding for Purchase of Common Stock (Detail) (October 2018 [Member], USD $) | 3 Months Ended | |
Mar. 31, 2015 | Dec. 31, 2014 | |
October 2018 [Member] | ||
Class of Warrant or Right [Line Items] | ||
Warrants outstanding | 152,735 | 206,340 |
Warrants outstanding, Exercise Price | $5.61 | |
Warrants outstanding, Expiration Date | 2018-10 |
Stockholders_Equity_Additional
Stockholders' Equity - Additional Information (Detail) (USD $) | 3 Months Ended | 1 Months Ended | |
In Millions, except Share data, unless otherwise specified | Mar. 31, 2015 | Feb. 28, 2014 | Jan. 31, 2014 |
Class of Stock [Line Items] | |||
Common stock reserved for issuance, description | The number of shares of common stock reserved for issuance will automatically increase on January 1 of each calendar year through January 1, 2023 by the least of (1) 1% of the total number of shares of the Company's common stock outstanding on December 31 of the preceding calendar year, (2) 384,307 shares, or (3) a number determined by the Company's board of directors that is less than (1) and (2). | ||
Unrecognized compensation cost | $23.40 | ||
Unrecognized compensation cost expected to be recognized as expense period | 3 years 6 months | ||
Common Stock Options [Member] | Maximum [Member] | |||
Class of Stock [Line Items] | |||
Options, expiration period | 10 years | ||
Common Stock Options [Member] | Minimum [Member] | |||
Class of Stock [Line Items] | |||
Options, vesting period | 4 years | ||
Prior Plans [Member] | Common Stock Options [Member] | |||
Class of Stock [Line Items] | |||
Shares available for grant | 0 | ||
2013 Equity Incentive Plan [Member] | |||
Class of Stock [Line Items] | |||
Percentage of common stock outstanding to increase shares reserved for issuance | 5.00% | ||
Common stock reserved for issuance, description | Additionally, the 2013 Equity Incentive Plan provides for the grant of performance cash awards. The number of shares of common stock reserved for issuance under the 2013 Equity Incentive Plan will automatically increase on January 1 of each year continuing through and including January 1, 2023 by 5% of the total number of shares of the Company's capital stock outstanding on December 31 of the preceding calendar year, or a lesser number of shares determined by the Company's board of directors. | ||
2013 Employee Stock Purchase Plan [Member] | |||
Class of Stock [Line Items] | |||
Percentage of common stock outstanding to increase shares reserved for issuance | 1.00% | ||
2013 Employee Stock Purchase Plan [Member] | Maximum [Member] | |||
Class of Stock [Line Items] | |||
Common stock authorized for issuance | 384,307 |
Stockholders_Equity_Summary_of1
Stockholders' Equity - Summary of Company's Stock Option and RSU Activity (Detail) | 3 Months Ended |
Mar. 31, 2015 | |
Equity [Abstract] | |
Options and RSUs, Outstanding at beginning | 2,408,634 |
Options and RSUs, Granted | 1,302,750 |
Options and RSUs, Exercised | -296,287 |
Options and RSUs, Cancelled | -15,000 |
Options and RSUs, Outstanding at ending | 3,400,097 |
Stockholders_Equity_Schedule_o
Stockholders' Equity - Schedule of Allocation of Stock-based Compensation for Equity Awards (Detail) (USD $) | 3 Months Ended | |
In Thousands, unless otherwise specified | Mar. 31, 2015 | Mar. 31, 2014 |
Share-based Compensation Arrangement by Share-based Payment Award, Compensation Cost [Line Items] | ||
Stock-based compensation expense | $2,103 | $519 |
Research and Development [Member] | ||
Share-based Compensation Arrangement by Share-based Payment Award, Compensation Cost [Line Items] | ||
Stock-based compensation expense | 909 | 343 |
General and Administrative [Member] | ||
Share-based Compensation Arrangement by Share-based Payment Award, Compensation Cost [Line Items] | ||
Stock-based compensation expense | $1,194 | $176 |
LongTerm_Obligations_Additiona
Long-Term Obligations - Additional Information (Detail) (USD $) | 3 Months Ended | 0 Months Ended | |||
Mar. 31, 2015 | Feb. 01, 2018 | Aug. 01, 2014 | Jul. 31, 2014 | Jun. 30, 2015 | |
Installment | |||||
Debt Instrument [Line Items] | |||||
Loan principal repayment, number of equal monthly installments | 30 | ||||
Loan agreement, milestone description | In April 2015, the Company's senior management and board of directors determined that the Company did not achieve the Milestone (see Note 8). Accordingly, the Company cannot draw down the second tranche of $15.0 million. | ||||
Capital Lease Obligations [Member] | |||||
Debt Instrument [Line Items] | |||||
Capital lease, number of payments | 60 | ||||
Capital lease obligations | 600 | ||||
Hercules Technology III L.P. and Hercules Technology Growth Capital, Inc. [Member] | |||||
Debt Instrument [Line Items] | |||||
Loan agreement, terms on interest rate calculation | The Loan accrues interest at a rate equal to the greater of either (i) 8.25% plus the prime rate as reported from time to time in The Wall Street Journal minus 5.25%, and (ii) 8.25%. Payments under the Loan Agreement are interest only until August 1, 2015. | ||||
Loan agreement, interest rate during the period | 8.25% | ||||
Prepayment charge | 1.50% | ||||
Maximum convertible limit of principal installment | 3,000,000 | ||||
Conversion price | 16.33 | ||||
Addition in interest rate on default | 5.00% | ||||
Hercules Technology III L.P. and Hercules Technology Growth Capital, Inc. [Member] | Prime Rate [Member] | |||||
Debt Instrument [Line Items] | |||||
Loan agreement, percentage to be reduced from interest rate under condition | -5.25% | ||||
Hercules Technology III L.P. and Hercules Technology Growth Capital, Inc. [Member] | First Tranche [Member] | |||||
Debt Instrument [Line Items] | |||||
Loan agreement, maximum borrowing capacity | 25,000,000 | ||||
Loan agreement, amount borrowed | 10,000,000 | ||||
Hercules Technology III L.P. and Hercules Technology Growth Capital, Inc. [Member] | Second Tranche [Member] | |||||
Debt Instrument [Line Items] | |||||
Expiration date of tranche | 30-Jun-15 | ||||
Hercules Technology III L.P. and Hercules Technology Growth Capital, Inc. [Member] | Scenario, Forecast [Member] | |||||
Debt Instrument [Line Items] | |||||
Loan fees | 1,750,000 | ||||
Hercules Technology III L.P. and Hercules Technology Growth Capital, Inc. [Member] | Scenario, Forecast [Member] | Second Tranche [Member] | |||||
Debt Instrument [Line Items] | |||||
Loan agreement, amount borrowed | $15,000,000 |
LongTerm_Obligations_Summary_o
Long-Term Obligations - Summary of Reconciliation of Future Contractual Principal and Final Fee Payments on Debt and Capital Lease Obligations (Detail) (USD $) | Mar. 31, 2015 | Dec. 31, 2014 |
In Thousands, unless otherwise specified | ||
Debt Instruments [Abstract] | ||
Total loan debt and capital lease obligations | $11,762 | $11,762 |
Less: Debt discount | -1,381 | -1,659 |
Total carrying value: | 10,381 | 10,103 |
Current and long-term | ||
Less: Carrying value of current portion of long-term obligations | -1,671 | -1 |
Carrying value of long-term obligations, less current portion | 8,710 | 10,102 |
Total carrying value: | $10,381 | $10,103 |
Subsequent_Events_Additional_I
Subsequent Events - Additional Information (Detail) | 3 Months Ended | 0 Months Ended | 3 Months Ended | 0 Months Ended | ||||||
Mar. 31, 2015 | Mar. 31, 2015 | Mar. 31, 2015 | Jun. 30, 2015 | Apr. 26, 2015 | Apr. 26, 2015 | Apr. 26, 2015 | Apr. 26, 2015 | Apr. 26, 2015 | Apr. 26, 2015 | |
Development Manufacturing And Supply Agreement [Member] | Development Manufacturing And Supply Agreement [Member] | Development Manufacturing And Supply Agreement [Member] | Subsequent Event [Member] | Subsequent Event [Member] | Subsequent Event [Member] | Subsequent Event [Member] | Subsequent Event [Member] | Subsequent Event [Member] | ||
EUR (€) | Scenario, Forecast [Member] | USD ($) | One-Time Severance Payments [Member] | Continuation Of Benefits [Member] | Outplacement Service Benefits [Member] | Retention Program [Member] | ||||
EUR (€) | Employees | USD ($) | USD ($) | USD ($) | USD ($) | |||||
Subsequent Event [Line Items] | ||||||||||
Results of MYDICAR phase 2b trial description | On April 26, 2015, the Company announced that its Phase 2b CUPID 2 trial did not meet its primary and secondary endpoints. CUPID 2 is a randomized, double-blind, placebo-controlled, multinational trial evaluating a single, one-time, intracoronary infusion of the cardiovascular gene therapy agent MYDICAR(R) (AAV1/SERCA2a) versus placebo added to a maximal, optimized heart failure drug and device regimen. In the study, the primary endpoint comparison of MYDICAR to placebo resulted in a hazard ratio in the MYDICAR group of 0.93; 95% confidence interval (CI), 0.53 to 1.65; p=81, defined as heart failure-related hospitalizations or ambulatory treatment for worsening heart failure. The secondary endpoint comparison of MYDICAR to placebo, defined as all-cause death, need for a mechanical circulatory support device, or heart transplant, likewise failed to show a significant treatment effect. The efficacy endpoint analyses were performed on the (n$3) modified intent to treat population (mITT), which excludes clinical events that occurred in patients who did not receive MYDICAR or placebo, or which occurred prior to dosing. All other exploratory efficacy endpoints (improvement in New York Heart Association classification, 6 Minute Walk Test, Quality of Life, and NT-proBNP) were also inconsistent with a treatment effect. No safety issues were noted. More extensive review of the data is ongoing at this time. | |||||||||
Reduction of current full-time employees initiation date | 26-Apr-15 | |||||||||
Reduction of current full-time employees percentage | 50.00% | |||||||||
Current full-time workforce | 34 | |||||||||
Reduction in force, description | In light of the CUPID 2 results, on April 26, 2015 the Company's board of directors approved an approximately 50% reduction of the Company's current full-time workforce of 34 employees in order to reduce operating expenses and conserve cash resources. | |||||||||
Expected workforce reduction and retention payments | $2,400,000 | $1,000,000 | $100,000 | $24,000 | $1,300,000 | |||||
Amount paid under agreement | 3,100,000 | |||||||||
Remaining payment agreed under agreement | € 1,700,000 | |||||||||
Termination of supply agreement, description | Effective April 29, 2015, the Company terminated the Development, Manufacturing and Supply Agreement by and between the Company and Novasep, Inc. (Novasep) dated March 20, 2015 (Novasep Agreement) pursuant to the Company's post CUPID 2 data termination right, after concluding that the recently un-blinded data from CUPID 2 was such that the Company does not require production of MYDICAR drug substance at Novasep's facility. | |||||||||
Termination date of agreement | 29-Apr-15 | |||||||||
Agreement entered date | 20-Mar-15 |