Document_And_Entity_Informatio
Document And Entity Information | 6 Months Ended | |
Jun. 30, 2014 | Aug. 01, 2014 | |
Document and Entity Information [Abstract] | ' | ' |
Entity Registrant Name | 'SOPHIRIS BIO INC. | ' |
Document Type | '10-Q | ' |
Current Fiscal Year End Date | '--12-31 | ' |
Entity Common Stock, Shares Outstanding | ' | 16,844,736 |
Amendment Flag | 'false | ' |
Entity Central Index Key | '0001563855 | ' |
Entity Current Reporting Status | 'Yes | ' |
Entity Voluntary Filers | 'No | ' |
Entity Filer Category | 'Non-accelerated Filer | ' |
Entity Well-known Seasoned Issuer | 'No | ' |
Document Period End Date | 30-Jun-14 | ' |
Document Fiscal Year Focus | '2014 | ' |
Document Fiscal Period Focus | 'Q2 | ' |
Condensed_Consolidated_Balance
Condensed Consolidated Balance Sheets (Unaudited) (USD $) | Jun. 30, 2014 | Dec. 31, 2013 |
In Thousands, unless otherwise specified | ||
Current assets: | ' | ' |
Cash and cash equivalents | $21,255 | $14,839 |
Securities available-for-sale | 14,379 | 33,310 |
Other receivables | 15 | 48 |
Prepaid expenses | 3,009 | 3,598 |
Total current assets | 38,658 | 51,795 |
Property and equipment, net | 42 | 78 |
Other long-term assets | 19 | 19 |
Total assets | 38,719 | 51,892 |
Current liabilities: | ' | ' |
Accounts payable | 3,756 | 1,470 |
Accrued expenses | 1,816 | 2,181 |
Current portion of promissory notes | ' | 6,877 |
Total current liabilities | 5,572 | 10,528 |
Long-term promissory notes | 5,876 | ' |
Warrant liability | ' | 883 |
Stock-based compensation liability | 84 | 202 |
Total liabilities | 11,532 | 11,613 |
Shareholders’ equity: | ' | ' |
Common shares, unlimited authorized shares, no par value; 16,844,736 and 16,149,871 shares issued and outstanding at June 30, 2014 and December 31, 2013 | 113,089 | 111,204 |
Contributed surplus | 16,052 | 13,824 |
Accumulated other comprehensive gain | 102 | 98 |
Accumulated deficit | -102,056 | -84,847 |
Total shareholders’ equity | 27,187 | 40,279 |
Total liabilities and shareholders’ equity | $38,719 | $51,892 |
Condensed_Consolidated_Balance1
Condensed Consolidated Balance Sheets (Unaudited) (Parentheticals) (USD $) | Jun. 30, 2014 | Dec. 31, 2013 |
Common shares, authorized shares | ' | ' |
Common shares, par value (in Dollars per share) | $0 | $0 |
Common shares, shares issued | 16,844,736 | 16,149,871 |
Common shares, shares outstanding | 16,844,736 | 16,149,871 |
Condensed_Consolidated_Stateme
Condensed Consolidated Statements of Operations and Comprehensive Loss (Unaudited) (USD $) | 3 Months Ended | 6 Months Ended | ||
In Thousands, except Per Share data, unless otherwise specified | Jun. 30, 2014 | Jun. 30, 2013 | Jun. 30, 2014 | Jun. 30, 2013 |
Revenues: | ' | ' | ' | ' |
License revenue | ' | ' | ' | $5,000 |
Operating expenses: | ' | ' | ' | ' |
Research and development | 7,088 | 1,155 | 13,918 | 4,025 |
General and administrative | 1,495 | 880 | 2,946 | 2,126 |
Total operating expenses | 8,583 | 2,035 | 16,864 | 6,151 |
Other income (expense): | ' | ' | ' | ' |
Interest expense | -168 | -352 | -376 | -751 |
Interest income | 12 | ' | 30 | ' |
Gain on revaluation of warrant liability | 20 | ' | 49 | ' |
Other income (expense), net | -31 | -255 | -48 | -356 |
Total other income (expense) | -167 | -607 | -345 | -1,107 |
Net loss before income taxes | -8,750 | -2,642 | -17,209 | -2,258 |
Income tax expense | ' | ' | ' | -500 |
Net loss | -8,750 | -2,642 | -17,209 | -2,758 |
Basic and diluted loss per share (in Dollars per share) | ($0.53) | ($0.84) | ($1.05) | ($0.88) |
Weighted average number of outstanding shares – basic and diluted (in Shares) | 16,493 | 3,150 | 16,323 | 3,150 |
Other comprehensive income (loss): | ' | ' | ' | ' |
Foreign currency translation adjustment | ' | 191 | ' | 299 |
Unrealized gain on securities available-for-sale | 1 | ' | 4 | ' |
Total other comprehensive loss | ($8,749) | ($2,451) | ($17,205) | ($2,459) |
Condensed_Consolidated_Stateme1
Condensed Consolidated Statements of Cash Flows (Unaudited) (USD $) | 6 Months Ended | |
Jun. 30, 2014 | Jun. 30, 2013 | |
Cash flows used in operating activities | ' | ' |
Net loss for the period | ($17,209,000) | ($2,758,000) |
Adjustments to reconcile net loss to net cash used by operating activities: | ' | ' |
Stock-based compensation | 1,153,000 | 525,000 |
Accretion of debt discount | 123,000 | 208,000 |
Depreciation of property and equipment | 37,000 | 42,000 |
Amortization of promissory note issuance costs | 38,000 | 61,000 |
Amortization of discount on securities available-for-sale | 30,000 | ' |
Change in fair value warrant liability | -49,000 | ' |
Foreign exchange transaction loss | 11,000 | 388,000 |
Other | 3,000 | ' |
Changes in operating assets and liabilities: | ' | ' |
Other receivables | 33,000 | 35,000 |
Prepaid expenses | 550,000 | 198,000 |
Accounts payable | 2,196,000 | 555,000 |
Accrued expenses | -330,000 | -1,394,000 |
Net cash used in operating activities | -13,414,000 | -2,140,000 |
Cash flows provided by (used in) investing activities | ' | ' |
Purchases of property and equipment | -3,000 | -3,000 |
Maturities of securities available-for-sale | 30,401,000 | ' |
Purchases of securities available-for-sale | -11,496,000 | ' |
Net cash provided by (used in) investing activities | 18,902,000 | -3,000 |
Cash flows provided by (used in) financing activities | ' | ' |
Issuance of common shares from private placement, net of issuance cost | 1,984,000 | ' |
Payment of issuance costs in connection with public offering | -53,000 | ' |
Cash received from the issuance of promissory notes | 2,362,000 | ' |
Principal payments on promissory notes | -3,361,000 | -2,878,000 |
Deferred financing costs | ' | -1,040,000 |
Net cash provided by (used in) financing activities | 932,000 | -3,918,000 |
Effect of exchange rate changes on cash and cash equivalents | -4,000 | -90,000 |
Net increase (decrease) in cash and cash equivalents | 6,416,000 | -6,151,000 |
Cash and cash equivalents at beginning of period | 14,839,000 | 9,721,000 |
Cash and cash equivalents at end of period | 21,255,000 | 3,570,000 |
Supplemental disclosures of non-cash investing and financing activities: | ' | ' |
Reclassification of fair value of warrant liability to equity as a result of the amendment of the underlying common share purchase warrants | 834,000 | ' |
Value of warrants issued in connection with promissory notes | 124,000 | ' |
Change in the fair value of stock-based compensation liability recorded to contributed surplus | $118,000 | ' |
Note_1_Nature_of_the_Business
Note 1 - Nature of the Business | 6 Months Ended | |
Jun. 30, 2014 | ||
Disclosure Text Block [Abstract] | ' | |
Nature of Operations [Text Block] | ' | |
1 | Nature of the business | |
Company | ||
Sophiris Bio Inc., or the Company, or Sophiris, is a clinical-stage biopharmaceutical company currently developing PRX302 for treatment of the symptoms of benign prostatic hyperplasia, or BPH, commonly referred to as an enlarged prostate and is planning to initiate a proof of concept study of PRX302 for the treatment of prostate cancer in the second half of 2014. The Company is governed by the British Columbia Business Corporations Act and began operations on January 11, 2002. The Company’s operations were initially located in Vancouver, British Columbia until April 2011, when its core activities and headquarters relocated from Vancouver, British Columbia to San Diego, California. |
Note_2_Recently_Adopted_Accoun
Note 2 - Recently Adopted Accounting Pronouncements | 6 Months Ended | |
Jun. 30, 2014 | ||
New Accounting Pronouncements and Changes in Accounting Principles [Abstract] | ' | |
New Accounting Pronouncements and Changes in Accounting Principles [Text Block] | ' | |
2 | Recently adopted accounting pronouncements | |
On June 10, 2014, the Financial Accounting Standards Board, or FASB, issued Accounting Standards Update, or ASU, ASU No. 2014-10, “Development Stage Entities (Topic 915) – Elimination of Certain Financial Reporting Requirements, Including an Amendment to Variable Interest Entities Guidance in Topic 810, Consolidation,” which eliminates the concept of a development stage entity in its entirety from current accounting guidance and provides for certain amendments to the consolidation guidance in Topic 810 in the Accounting Standards Codification, or ASC. Prior to the issuance of this guidance the Company was considered a development stage entity and as a result the Company included certain inception-to-date disclosures in its financial statements. The guidance related to the elimination of concept of a development stage entity is effective for public companies for annual reporting periods beginning after December 15, 2014, and interim periods therein. The amendment of the consolidation guidance in Topic 810 is effective for public companies for annual reporting periods beginning after December 15, 2015. Early adoption of the new standard is permitted. ASU No. 2014-10 was adopted by the Company during the quarter ended June 30, 2014. As such all inception-to-date disclosures have been removed from these condensed consolidated financial statements. |
Note_3_Summary_of_Significant_
Note 3 - Summary of Significant Accounting Policies | 6 Months Ended | ||
Jun. 30, 2014 | |||
Accounting Policies [Abstract] | ' | ||
Significant Accounting Policies [Text Block] | ' | ||
3 | Summary of significant accounting policies | ||
Significant accounting policies followed by the Company in the preparation of its condensed consolidated financial statements are as follows: | |||
Basis of consolidation | |||
The condensed consolidated financial statements include the accounts of the Company, Sophiris Bio Corp. and Sophiris Bio Holding Corp. All intercompany balances and transactions have been eliminated for purposes of consolidation. | |||
Basis of presentation and use of estimates | |||
The accompanying unaudited condensed consolidated financial statements have been prepared in conformity with generally accepted accounting principles in the United States, or GAAP, for the interim financial information and the rules and regulations of the Securities and Exchange Commission, or SEC, related to quarterly reports on Form 10-Q. Accordingly, they do not include all of the information and disclosures required by GAAP for annual audited financial statements and should be read in conjunction with the Company’s audited consolidated financial statements and notes thereto included in the Company’s Annual Report on Form 10-K, or Annual Report, filed with the SEC. The year-end condensed balance sheet data was derived from the audited consolidated financial statements, but does not include all disclosures required by GAAP. In the opinion of management, these condensed consolidated financial statements include all adjustments (consisting of normal recurring adjustments) necessary for a fair statement of the financial position, results of operations and cash flows for the periods presented. The results of operations for the interim periods shown in this report are not necessarily indicative of the results that may be expected for any future period, including the full year. | |||
GAAP requires the Company’s management to make estimates and judgments that may affect the reported amounts of assets, liabilities, revenue, expenses and related disclosures. The Company bases estimates and judgments on historical experience and on various other factors that it believes to be reasonable under the circumstances. The significant estimates in these condensed consolidated financial statements include revenue recognition, stock-based compensation expense, warrant liability, functional currency and accrued research and development expenses, including accruals related to the Company’s ongoing clinical trial. The Company’s actual results may differ from these estimates. The Company evaluates its estimates on an ongoing basis. Changes in estimates are reflected in reported results in the period in which they become known by the Company’s management. | |||
Foreign currency | |||
Gains and losses resulting from foreign currency translation are recorded in accumulated other comprehensive gain (loss), which is a separate component of stockholders’ equity. Foreign currency transaction gains and losses are recognized as a component of other income (expense), net. The Company recorded foreign exchange transaction losses of $29,000 and $45,000 for the three months and six months ended June 30, 2014, respectively, and $255,000 and $388,000 for the three and six months ended June 30, 2013, respectively. | |||
Cash and cash equivalents | |||
Cash equivalents are short-term, highly liquid investments with an original maturity of three months or less at the date of purchase. | |||
Securities Available-for-Sale | |||
Investments with an original maturity of more than three months when purchased have been classified by management as securities available-for-sale. Such investments are carried at fair value, with unrealized gains and losses included as a component of accumulated other comprehensive gain (loss) in shareholders’ equity. Realized gains and losses on available-for-sale securities are included in interest income. No other-than-temporary impairments were identified for the investment securities held by the Company as of June 30, 2014 or December 31, 2013.The cost of investment securities classified as available-for-sale is adjusted for amortization of premiums and accretion of discounts to maturity. Such amortization and accretion are included in interest income. The cost of securities sold is based on the specific-identification method. The Company has classified all of its investment securities as available-for-sale, including those with maturities beyond one year, as current assets on the consolidated balance sheets based on the highly liquid nature of the investment securities and because these investment securities are considered available for use in current operations. | |||
Revenue recognition | |||
The Company may enter into product development agreements with collaborative partners for the research and development of products for the treatment of urological diseases. The terms of the agreements may include nonrefundable signing and licensing fees, milestone payments and royalties on any product sales derived from collaborations. These multiple element arrangements are analyzed to determine whether the deliverables can be separated or whether they must be accounted for as a single unit of accounting. License fees are recognized as revenue when persuasive evidence of an arrangement exists, the fee is fixed or determinable, delivery or performance has substantially completed and collection is reasonably assured. | |||
The Company recognizes up front license payments as revenue upon delivery of the license only if the license has stand-alone value to the customer and if the agreement includes a general right of return, the delivery or performance of undelivered items is considered probable and within the control of the Company. The payment is generally allocated to the separate units of accounting based on their relative selling prices. The selling price of each deliverable is determined using vendor specific objective evidence of selling prices, if it exists; otherwise, third-party evidence of selling prices. If neither vendor specific objective evidence nor third-party evidence exists, the Company uses its’ best estimate of the selling price for each deliverable. The payment allocated is limited to the amount that is not contingent on the delivery of additional items or fulfillment of other performance conditions. | |||
Whenever the Company determines that an arrangement should be accounted for as a single unit of accounting, it must determine the period over which the performance obligations will be performed and revenue recognized. If the Company cannot reasonably estimate the timing and the level of effort to complete its performance obligations under the arrangement, then revenue under the arrangement is recognized on a straight-line basis over the period the Company is expected to complete its performance obligations. | |||
The Company evaluates milestone payments on an individual basis and recognizes revenue from non-refundable milestone payments when the earnings process is complete and the payment is reasonably assured. Non-refundable milestone payments related to arrangements under which the Company has continuing performance obligations are recognized as revenue upon achievement of the associated milestone, provided that (i) the milestone event is substantive and its achievability was not reasonably assured at the inception of the agreement and (ii) the amount of the milestone payment is reasonable in relation to the effort expended or the risk associated with the milestone event. Any amounts received under agreements in advance of performance, if deemed substantive, are recorded as deferred revenue and recognized as revenue as the Company completes its performance obligations. A milestone event is considered substantive if (i) the milestone is commensurate with either (a) the Company’s performance to achieve the milestone or (b) the enhancement of the value of the delivered item(s) as a result of a specific outcome resulting from the Company’s performance to achieve the milestone; (ii) it relates solely to past performance and (iii) it is reasonable relative to all of the deliverables and payment terms (including other potential milestone consideration) within the arrangement. If any portion of the milestone payment does not relate to the Company’s performance, does not relate solely to past performance or is refundable or adjustable based on future performance, the milestone is not considered to be substantive. Milestone payments are not bifurcated into substantive and non-substantive components. Payments related to the achievement of non-substantive milestones is deferred and recognized over the Company’s remaining performance period. | |||
Royalty revenue will be recognized upon the sale of the related products provided the Company has no remaining performance obligations under the arrangement. | |||
Research and development expenses | |||
Research and development costs are charged to expense as incurred. Research and development expenses comprise costs incurred in performing research and development activities, including personnel-related costs, stock-based compensation, facilities, research-related overhead, clinical trial costs, contracted services, manufacturing, license fees and other external costs. The Company accounts for nonrefundable advance payments for goods and services that will be used in future research and development activities as expenses when the service has been performed or when the goods have been consumed rather than when the payment is made. | |||
Accrued research and development expenses | |||
Clinical trial costs are recorded as a component of research and development expenses. The Company accrues and expenses clinical trial activities performed by third parties based upon estimates of the percentage of work completed over the life of the individual study in accordance with agreements established with clinical research organizations and clinical trial sites. The Company determines the estimates through discussions with internal clinical personnel and external service providers as to the progress or stage of completion of trials or services and the agreed-upon fee to be paid for such services based on facts and circumstances known to the Company as of each balance sheet date. However, actual costs and timing of clinical trials are highly uncertain, subject to risks and may change depending upon a number of factors, including the Company’s clinical development plan. The process of estimating clinical trial costs may become more complex as the Company’s ongoing and planned Phase 3 clinical trials will involve larger numbers of patients and clinical sites. | |||
If the actual timing of the performance of services or the level of effort varies from the estimate, the Company will adjust the accrual accordingly. Adjustments to prior period estimates have not been material. | |||
Examples of estimated accrued research and development expenses include: | |||
• | fees paid to clinical research organizations in connection with clinical studies; | ||
• | fees paid to investigative sites in connection with clinical studies; | ||
• | fees paid to vendors in connection with preclinical development activities; | ||
• | fees paid to vendors associated with the development of companion diagnostics; and | ||
• | fees paid to vendors related to product manufacturing, development and distribution of clinical supplies. | ||
Nonrefundable advance payments for goods and services that will be used or rendered in future research and development activities, are recorded as a prepaid expense and recognized as expense in the period that the related goods are consumed or services are performed. | |||
Stock-based compensation | |||
The Company expenses the fair value of employee stock options over the vesting period. Compensation expense is measured using the fair value of the award at the grant date, net of estimated forfeitures, and is adjusted annually to reflect actual forfeitures. The fair value of each stock-based award is estimated using the Black-Scholes pricing model and is expensed using graded amortization over the vesting period. | |||
The Company accounts for stock options granted to non-employees, which primarily consist of members of the Company’s scientific advisory board and consultants, using the fair value approach. Stock options granted to non-employees are subject to revaluation each reporting period over their vesting terms. | |||
Historically the Company has issued its stock options with a Canadian dollar denominated exercise price. Subsequent to the Company’s initial public offering on the NASDAQ, the Company has issued its stock options with an U.S. dollar denominated exercise price. | |||
Effective November 13, 2013, the Company voluntarily delisted from the Toronto Stock Exchange, or TSX. Subsequent to November 13, 2013, the Company’s securities are being actively traded on only the NASDAQ. | |||
As a result of the delisting from the TSX and the change in the Company’s functional currency to the U.S. dollar, the stock options granted with exercise prices denominated in Canadian dollars are considered dual indexed as defined in ASC 718, “Compensation, Stock Compensation”. As a result of the stock options being dual indexed the Company is required to account for these stock options as a liability. Historically these options had been accounted for as equity. The estimated fair value is determined using the Black-Scholes pricing model based on the estimated value of the underlying common shares at the valuation measurement date, the remaining service period of the stock options, risk-free interest rates, expected dividends and expected volatility of the price of the underlying common shares. The fair value of the stock-based compensation liability was $84,000 at June 30, 2014. As the calculated fair value of the stock options at June 30, 2014 was less than the original grant date fair value no additional compensation expense was recorded in the consolidated statement of operations and comprehensive loss. The change in the fair value of the stock-based compensation liability for the three months ended June 30, 2014 of $98,000 and for the six months ended June 30, 2014 of $118,000 was recorded as an adjustment to Contributed Surplus. | |||
Fair value of financial instruments | |||
The Company measures certain financial assets and liabilities at fair value based on the exchange price that would be received for an asset or paid for to transfer a liability (an exit price) in the principal or most advantageous market for the asset or liability in an orderly transaction between market participants. The carrying amounts of the Company’s financial instruments, including cash and cash equivalents and accounts payable and accrued expenses, approximate fair value due to their short maturities. | |||
The Company follows ASC 820-10, “Fair Value Measurements and Disclosures,” which among other things, 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 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, a three-tier fair value hierarchy has been established, which prioritizes the inputs used in measuring fair value as follows: | |||
Level 1 – Inputs are unadjusted, quoted prices in active markets for identical assets or liabilities at the measurement date. | |||
Level 2 – Inputs (other than quoted prices included in Level 1) are either directly or indirectly observable for the asset or liability through correlation with market data at the measurement date and for the duration of the instrument’s anticipated life. | |||
Level 3 – Inputs reflect management’s best estimate of what market participants would use in pricing the asset or liability at the measurement date. Consideration is given to the risk inherent in the valuation technique and the risk inherent in the inputs to the model. | |||
Recent accounting pronouncements | |||
In May 2014, the FASB issued authoritative accounting guidance related to revenue from contracts with customers. This guidance is a comprehensive new revenue recognition model that requires a company to recognize revenue to depict the transfer of goods or services to a customer at an amount that reflects the consideration it expects to receive in exchange for those goods or services. This guidance is effective for annual reporting periods beginning after December 15, 2016 and early adoption is not permitted. The Company will adopt this guidance on January 1, 2017. Companies may use either a full retrospective or a modified retrospective approach to adopt this guidance. The Company is evaluating which transition approach to use and its impact, if any, on its consolidated financial statements. |
Note_4_Net_Loss_per_Common_Sha
Note 4 - Net Loss per Common Share | 6 Months Ended | ||||||||
Jun. 30, 2014 | |||||||||
Earnings Per Share [Abstract] | ' | ||||||||
Earnings Per Share [Text Block] | ' | ||||||||
4. Net loss per common share | |||||||||
Basic net loss per share is calculated by dividing the net loss attributable to common shareholders by the weighted-average number of common shares outstanding during the period, without consideration for common shares equivalents. Diluted net loss per share is computed by dividing the net loss attributable to common shareholders by the weighted-average number of common share equivalents outstanding for the period determined using the treasury-stock method. | |||||||||
The following diluted securities have been excluded from the computation of diluted weighted-average shares outstanding as of June 30, 2014 and June 30, 2013 as the Company recorded a net loss in all periods and therefore they would be anti-dilutive (in thousands): | |||||||||
30-Jun-14 | 30-Jun-13 | ||||||||
Options to purchase common shares | 1,386 | 301 | |||||||
Common share purchase warrants | 1,001 | 919 | |||||||
Note_5_Securities_Availablefor
Note 5 - Securities Available-for-Sale | 6 Months Ended | ||||||||||||||||
Jun. 30, 2014 | |||||||||||||||||
Investments, Debt and Equity Securities [Abstract] | ' | ||||||||||||||||
Investments in Debt and Marketable Equity Securities (and Certain Trading Assets) Disclosure [Text Block] | ' | ||||||||||||||||
5 | Securities Available-for-Sale | ||||||||||||||||
Securities available-for-sale consisted of the following as of June 30, 2014 (in thousands): | |||||||||||||||||
30-Jun-14 | |||||||||||||||||
Amortized | Unrealized | Estimated | |||||||||||||||
Cost | Gain | Loss | Fair Value | ||||||||||||||
Commercial paper | $ | 9,498 | $ | — | $ | — | $ | 9,498 | |||||||||
U.S. government sponsored enterprise securities | 2,006 | — | — | 2,006 | |||||||||||||
Corporate debt securities | 2,872 | 3 | — | 2,875 | |||||||||||||
$ | 14,376 | $ | 3 | $ | — | $ | 14,379 | ||||||||||
The amortized cost and estimated fair value of the Company securities available-for-sale by contractual maturity as of June 30, 2014 are shown below (in thousands): | |||||||||||||||||
30-Jun-14 | |||||||||||||||||
Amortized | Unrealized | Estimated | |||||||||||||||
Cost | Gain | Loss | Fair Value | ||||||||||||||
Within one year | $ | 9,498 | $ | — | $ | — | $ | 9,498 | |||||||||
After one year | 4,878 | 3 | — | 4,881 | |||||||||||||
$ | 14,376 | $ | 3 | $ | — | $ | 14,379 | ||||||||||
Securities available-for-sale consisted of the following as of December 31, 2013 (in thousands): | |||||||||||||||||
31-Dec-13 | |||||||||||||||||
Amortized | Unrealized | Estimated | |||||||||||||||
Cost | Gain | Loss | Fair Value | ||||||||||||||
Commercial paper | $ | 9,798 | $ | — | $ | — | $ | 9,798 | |||||||||
U.S. government sponsored enterprise securities | 17,007 | 2 | (4 | ) | 17,005 | ||||||||||||
Corporate debt securities | 6,506 | 2 | (1 | ) | 6,507 | ||||||||||||
$ | 33,311 | $ | 4 | $ | (5 | ) | $ | 33,310 | |||||||||
The amortized cost and estimated fair value of the Company securities available-for-sale by contractual maturity as of December 31, 2013 are shown below (in thousands): | |||||||||||||||||
31-Dec-13 | |||||||||||||||||
Amortized | Unrealized | Estimated | |||||||||||||||
Cost | Gain | Loss | Fair Value | ||||||||||||||
Within one year | $ | 30,430 | $ | 2 | $ | (4 | ) | $ | 30,428 | ||||||||
After one year | 2,881 | 2 | (1 | ) | 2,882 | ||||||||||||
$ | 33,311 | $ | 4 | $ | (5 | ) | $ | 33,310 | |||||||||
Note_6_Fair_Value_Measurement_
Note 6 - Fair Value Measurement and Financial Instruments | 6 Months Ended | ||||||||||||||||
Jun. 30, 2014 | |||||||||||||||||
Fair Value Disclosures [Abstract] | ' | ||||||||||||||||
Fair Value Disclosures [Text Block] | ' | ||||||||||||||||
6. Fair value measurement and financial instruments | |||||||||||||||||
As of June 30, 2014, the Company has $28.0 million of securities consisting of money market funds, commercial paper, U.S. government sponsored enterprise securities and corporate debt securities with maturities that range from 1 day to 9 months with an overall average time to maturity of 2.5 months. The Company has the ability to liquidate these investments without restriction. The Company determines fair value for securities with Level 1 inputs through quoted market prices. The Company determines fair value for securities with Level 2 inputs through broker or dealer quotations or alternative pricing sources with reasonable levels of price transparency. The Company’s Level 2 securities have been initially valued at the transaction price and subsequently valued, at the end of each reporting period, typically utilizing third party pricing services or other observable market data. The pricing services utilize industry standard valuation models, including both income and market based approaches and observable market inputs to determine value. These observable market inputs include reportable trades, benchmark yields, credit spreads, broker/dealer quotes, bids, offers, and other industry and economic events. The Company’s Level 3 inputs are unobservable inputs based on the Company’s assessment that market participants would use in pricing the instruments. | |||||||||||||||||
The following table presents the Company’s assets and liabilities that are measured at fair value on a recurring basis for the periods presented (in thousands): | |||||||||||||||||
30-Jun-14 | Level 1 | Level 2 | Level 3 | ||||||||||||||
Assets: | |||||||||||||||||
Money market funds | $ | 1,793 | $ | 1,793 | $ | — | $ | — | |||||||||
Commercial paper | 21,297 | — | 21,297 | — | |||||||||||||
U.S. government sponsored enterprise securities | 2,006 | — | 2,006 | — | |||||||||||||
Corporate debt securities | 2,875 | — | 2,875 | — | |||||||||||||
Total assets | $ | 27,971 | $ | 1,793 | $ | 26,178 | $ | — | |||||||||
Liabilities: | |||||||||||||||||
Warrant liability | $ | — | $ | — | $ | — | $ | — | |||||||||
Stock-based compensation liability | 84 | — | — | 84 | |||||||||||||
Total liabilities | $ | 84 | $ | — | $ | — | $ | 84 | |||||||||
31-Dec-13 | Level 1 | Level 2 | Level 3 | ||||||||||||||
Assets: | |||||||||||||||||
Money market funds | $ | 55 | $ | 55 | $ | — | $ | — | |||||||||
Commercial paper | 23,570 | — | 23,570 | — | |||||||||||||
U.S. government sponsored enterprise securities | 17,005 | — | 17,005 | — | |||||||||||||
Corporate debt securities | 6,507 | — | 6,507 | — | |||||||||||||
Total assets | $ | 47,137 | $ | 55 | $ | 47,082 | $ | — | |||||||||
Liabilities: | |||||||||||||||||
Warrant liability | $ | 883 | $ | — | $ | — | $ | 883 | |||||||||
Stock-based compensation liability | 202 | — | — | 202 | |||||||||||||
Total liabilities | $ | 1,085 | $ | — | $ | — | $ | 1,085 | |||||||||
The Company calculates the fair value of the common share purchase warrants with exercise prices denominated in Canadian dollars (level 3) at each reporting period utilizing a Black-Scholes pricing model. The following inputs were utilized in the Black-Scholes pricing model: | |||||||||||||||||
30-Jun-14 | 31-Dec-13 | ||||||||||||||||
Stock price | $ | 2.24 | $ | 3.7 | |||||||||||||
Weighted average exercise price | $ | 31.68 | $ | 25.45 | |||||||||||||
Risk-free interest rate | 0.11 | % | 0.62 | % | |||||||||||||
Volatility | 51.24 | % | 115.09 | % | |||||||||||||
Dividend yield | 0 | % | 0 | % | |||||||||||||
Expected life in years | 0.71 | 2.51 | |||||||||||||||
Calculated fair value per common share purchase warrant | $ | - | $ | 0.96 | |||||||||||||
The Company calculates the fair value of the stock-based compensation liability (level 3) at each reporting period utilizing a Black-Scholes pricing model. The following inputs were utilized in the Black-Scholes pricing model: | |||||||||||||||||
30-Jun-14 | 31-Dec-13 | ||||||||||||||||
Stock price | $ | 2.24 | $ | 3.7 | |||||||||||||
Weighted average exercise price | $ | 17.53 | $ | 17.66 | |||||||||||||
Risk-free interest rate | 0.85 | % | 1 | % | |||||||||||||
Volatility | 95.37 | % | 94.53 | % | |||||||||||||
Dividend yield | 0 | % | 0 | % | |||||||||||||
Expected life in years | 2.93 | 3.42 | |||||||||||||||
Calculated fair value per stock option | $ | 0.41 | $ | 1.17 | |||||||||||||
The following table presents a reconciliation of the warrant liability measured at fair value using unobservable inputs (Level 3) (in thousands): | |||||||||||||||||
Three Months Ended | Six Months Ended | ||||||||||||||||
30-Jun-14 | 30-Jun-14 | ||||||||||||||||
Liabilities: | |||||||||||||||||
Balance at beginning of period: | $ | 20 | $ | 883 | |||||||||||||
Reclassification of fair value of warrant liability to equity as a result of the amendment to convert the exercise price of certain warrants from Canadian dollars to U.S dollars of the underlying common share purchase warrants | - | (834 | ) | ||||||||||||||
Change in fair value of warrant liability included in other income (expense), net | (20 | ) | (49 | ) | |||||||||||||
Balance at end of period: | $ | - | $ | - | |||||||||||||
The following table presents a reconciliation of the stock-based compensation liability measured at fair value using unobservable inputs (Level 3) (in thousands): | |||||||||||||||||
Three Months Ended | Six Months Ended | ||||||||||||||||
30-Jun-14 | 30-Jun-14 | ||||||||||||||||
Liabilities: | |||||||||||||||||
Balance at beginning of period: | $ | 181 | $ | 202 | |||||||||||||
Change in fair value of stock-based compensation liability recorded as an adjustment to contributed surplus | (97 | ) | (118 | ) | |||||||||||||
Balance at end of period: | $ | 84 | $ | 84 | |||||||||||||
There were no transfers of assets or liabilities between the fair value measurement classifications. |
Note_7_Prepaid_Expenses
Note 7 - Prepaid Expenses | 6 Months Ended | ||||||||
Jun. 30, 2014 | |||||||||
Prepaid Expenses And Other Assets [Abstract] | ' | ||||||||
Prepaid Expenses And Other Assets [Text Block] | ' | ||||||||
7 | Prepaid expenses | ||||||||
Prepaid expenses as of June 30, 2014 and December 31, 2013 consisted of the following (in thousands): | |||||||||
June 30, | December 31, | ||||||||
2014 | 2013 | ||||||||
Prepaid insurance | $ | 81 | $ | 292 | |||||
Prepaid research and development expenses | 2,894 | 3,218 | |||||||
Other prepaid expenses | 34 | 88 | |||||||
$ | 3,009 | $ | 3,598 | ||||||
As of June 30, 2014 and December 31, 2013, prepaid research and development expenses includes $2.6 million and $2.7 million, respectively for upfront fees paid to our clinical research organizations assisting with our on-going Phase 3 clinical trial. The upfront fees will be relieved in future periods by offsetting future invoices based upon work completed. |
Note_8_Accrued_Expenses
Note 8 - Accrued Expenses | 6 Months Ended | ||||||||
Jun. 30, 2014 | |||||||||
Payables and Accruals [Abstract] | ' | ||||||||
Accounts Payable and Accrued Liabilities Disclosure [Text Block] | ' | ||||||||
8 | Accrued expenses | ||||||||
Accrued expenses as of June 30, 2014 and December 31, 2013 consisted of the following (in thousands): | |||||||||
June 30, | December 31, | ||||||||
2014 | 2013 | ||||||||
Accrued personnel related costs | $ | 642 | $ | 1,063 | |||||
Accrued interest | - | 50 | |||||||
Accrued research and development expenses | 918 | 713 | |||||||
Other accrued expenses | 256 | 355 | |||||||
$ | 1,816 | $ | 2,181 | ||||||
Note_9_Promissory_Notes
Note 9 - Promissory Notes | 6 Months Ended | ||||||||||||||||
Jun. 30, 2014 | |||||||||||||||||
Debt Disclosure [Abstract] | ' | ||||||||||||||||
Debt Disclosure [Text Block] | ' | ||||||||||||||||
9 | Promissory notes | ||||||||||||||||
In July 2011, the Company entered into a $15 million Loan and Security Agreement, as amended, or the Original Loan, with Oxford Finance LLC, or Oxford. Under the terms of the Original Loan, the Company made interest only payments for nine months at a fixed interest rate of 9.5%. Beginning in June 2012, the note began to amortize with principal and interest payments due through the remaining term of the loan. The Original Loan could be prepaid subject to certain provisions and prepayment fees. Upon final payment of the Original Loan, the Company was required to pay an additional fee of 5% of the original principal amount, which was being recognized over the term of the loan. | |||||||||||||||||
On June 30, 2014, we entered into a new Loan and Security Agreement, or the New Loan, with Oxford. Under the New Loan, Oxford has loaned a principal amount of $6.0 million to the Company to refinance the Company’s existing term loan with Oxford and to provide additional working capital. | |||||||||||||||||
The principal amount was used by us to settle approximately $2.9 million of outstanding principal on the Company’s Original Loan, to settle accrued interest on such existing term loan, to settle other fees and expenses, including $0.7 million for a final payment due under the Original Loan, and the remaining cash proceeds of approximately $2.3 million will be used for general corporate purposes. | |||||||||||||||||
The principal borrowed under the New Loan bears fixed interest of 9.504% per annum. The Company has the option to prepay the outstanding balance of the New Loan in full, subject to a prepayment fee of 1% to 3% depending upon when the prepayment occurs. Upon the final repayment of the New Loan on the maturity date, by prepayment, or upon acceleration, the Company shall pay Oxford an additional fee of 5% of the principal amount of $6.0 million. This additional fee is recorded as a debt discount and is being recognized as interest expense over the life of the loan utilizing the effective interest method. The repayment terms are interest only payments through July 1, 2015 followed by 36 equal monthly payments of principal and interest. We accounted for the New Loan as a modification. | |||||||||||||||||
Pursuant to the New Loan, on June 30, 2014, the Company issued to Oxford warrants to purchase an aggregate of up to 82,192 of the Company’s common shares at an exercise price of $2.19 per share. The warrants will expire seven years from the date of the grant. The fair value of $0.1 million for this equity component was derived using the Black-Scholes pricing model utilizing the following inputs: risk-free interest rate – 2.1%, volatility – 72.1%, dividend yield – 0% and expected life in years – 7. The $6.0 million proceeds were allocated to equity and the debt based on their relative fair values. As of June 30, 2014, the Company has classified the debt as level 3 in the fair value hierarchy for which the relative fair value of the debt is $5.9 million. The debt discount will be amortized to interest expense over the life of the debt. Interest on the term loan, consisting of the stated interest rate, final payment fee and amortization of the discount, is being recognized under the effective interest method. | |||||||||||||||||
The third party fees incurred related to the New Loan of $0.1 million were expensed during the three months ended June 30, 2014. | |||||||||||||||||
In connection with the New Loan, the Company granted to Oxford a security interest in all of the Company’s personal property now owned or hereafter acquired, excluding intellectual property and certain other assets. | |||||||||||||||||
As of June 30, 2014, the Company was in compliance with all material covenants under the New Loan. | |||||||||||||||||
As of June 30, 2014, the future contractual principal and final fee payments on our debt obligations are as follows (in thousands): | |||||||||||||||||
2014 | $ | — | |||||||||||||||
2015 | 735 | ||||||||||||||||
2016 | 1,887 | ||||||||||||||||
2017 | 2,074 | ||||||||||||||||
2018 | 1,604 | ||||||||||||||||
Total | $ | 6,300 | |||||||||||||||
The following table shows actual interest expensed and amortization of the debt discount that was charged to interest expense (in thousands): | |||||||||||||||||
Three Months Ended June 30, | Six Months Ended June 30, | ||||||||||||||||
2014 | 2013 | 2014 | 2013 | ||||||||||||||
Simple interest | $ | 92 | $ | 224 | $ | 215 | $ | 482 | |||||||||
Accretion of debt discount | 55 | 99 | 123 | 208 | |||||||||||||
Amortization of promissory notes issuance costs | 21 | 29 | 38 | 61 | |||||||||||||
$ | 168 | $ | 352 | $ | 376 | $ | 751 | ||||||||||
Note_10_Common_Stock_Purchase_
Note 10 - Common Stock Purchase Agreement with Aspire Capital | 6 Months Ended | |
Jun. 30, 2014 | ||
Stockholders' Equity Note [Abstract] | ' | |
Stockholders' Equity Note Disclosure [Text Block] | ' | |
10 | Common stock purchase agreement with Aspire Capital | |
On May 16, 2014, the Company entered into a common stock purchase agreement, or the Purchase Agreement, with Aspire Capital Fund, LLC, or Aspire Capital, which provides that Aspire Capital is committed to purchase up to an aggregate of $15.0 million of the Company’s common shares over the approximately 30-month term of the Purchase Agreement. In consideration for entering into the Purchase Agreement, concurrently with the execution of the Purchase Agreement, the Company issued to Aspire Capital 90,635 of the Company’s common shares. Upon the execution of the Purchase Agreement, the Company sold to Aspire Capital 604,230 common shares at $3.31 per share for net proceeds of $1.9 million which was recorded as in increase to common shares on the balance sheet. The Company incurred offering costs of $0.1 million associated with this transaction. | ||
Over the remaining 29 months the Company has the right, subject to certain limitations including but not limited to the Company’s closing stock price not falling below $2.00 on the date of any directed purchase, to direct Aspire Capital to purchase up to an additional $13 million of our common shares. As of August 7, 2014, there have been no additional sales of common shares to Aspire Capital pursuant to the Purchase Agreement. |
Note_11_Stockbased_Compensatio
Note 11 - Stock-based Compensation Plan | 6 Months Ended | ||||||||||||||||
Jun. 30, 2014 | |||||||||||||||||
Disclosure of Compensation Related Costs, Share-based Payments [Abstract] | ' | ||||||||||||||||
Disclosure of Compensation Related Costs, Share-based Payments [Text Block] | ' | ||||||||||||||||
11 | Stock-based compensation plan | ||||||||||||||||
Equity awards | |||||||||||||||||
The Company’s Amended and Restated 2011 Stock Option plan, or the Plan, provides for the granting of options for the purchase of common shares of the Company at the fair value of the Company’s common shares on the date of the option grant. Options are granted to employees, directors and non-employees. The board of directors or a committee appointed by the board of directors administers the Plan and has discretion as to the number, vesting period and expiry date of each option award. Historically the Company granted options to residents of the United States with an exercise price denominated in Canadian dollars, the functional currency of Sophiris Bio Inc. Inc. prior to the Company’s U.S. initial public offering. Following the Company’s U.S. initial public offering the Company will grant options with an exercise price denominated in U.S. dollars | |||||||||||||||||
The Company recognized stock-based compensation expense as follows (in thousands): | |||||||||||||||||
Three Months Ended June 30, | Six Months Ended June 30, | ||||||||||||||||
2014 | 2013 | 2014 | 2013 | ||||||||||||||
Research and development | $ | 153 | $ | 60 | $ | 346 | $ | 124 | |||||||||
General and administrative | 391 | 213 | 807 | 401 | |||||||||||||
Total | $ | 544 | $ | 273 | $ | 1,153 | $ | 525 | |||||||||
As of June 30, 2014 there was $1.5 million of total unrecognized compensation costs related to non-vested stock awards. As of June 30, 2014 the Company expects to recognize these costs over weighted average periods of approximately 1.2 years. | |||||||||||||||||
The fair values of options granted during the six months ended June 30, 2014 and 2013 were estimated at the date of grant using the following weighted-average assumptions: | |||||||||||||||||
Six Months Ended June 30, | |||||||||||||||||
2014 | 2013 | ||||||||||||||||
Expected life of the option term (years) | 3.7 | 4.2 | |||||||||||||||
Risk-free interest rate | 1.2 | % | 1.4 | % | |||||||||||||
Dividend rate | 0 | % | 0 | % | |||||||||||||
Volatility | 76.2 | % | 69.1 | % | |||||||||||||
Forfeiture rate | 5.3 | % | 8.8 | % | |||||||||||||
The following table summarizes stock option activity, including options issued to employees, directors and non-employees (in thousands, except per share): | |||||||||||||||||
Options | Weighted | Currency | |||||||||||||||
outstanding | average | ||||||||||||||||
exercise | |||||||||||||||||
price | |||||||||||||||||
Outstanding at January 1, 2014 | 1,362 | $ | 7.1 | US | |||||||||||||
Options granted | 87 | 2.57 | US | ||||||||||||||
Options forfeited | (9 | ) | 4.17 | CND | |||||||||||||
Options forfeited | (54 | ) | 3.79 | US | |||||||||||||
Outstanding at June 30, 2014 | 1,386 | $ | 3.51 | US | |||||||||||||
The total amounts of options outstanding at June 30, 2014 include options with exercise prices denominated in Canadian dollars and U.S. dollars and the Canadian dollar amounts have been converted to U.S. dollars at the exchange rate as of June 30, 2014 for purposes of the weighted average exercise price calculation. |
Note_12_Kissei_Agreement
Note 12 - Kissei Agreement | 6 Months Ended |
Jun. 30, 2014 | |
Organization, Consolidation and Presentation of Financial Statements [Abstract] | ' |
Collaborative Arrangement Disclosure [Text Block] | ' |
12. Kissei Agreement | |
In April 2010, the Company entered into an exclusive license agreement for the development and commercialization of PRX302 (and other products covered by the licensed patent). The agreement with Kissei Pharmaceuticals Co., Ltd., a Japanese pharmaceutical company, or Kissei covers the development and commercialization of PRX302 in Japan for the treatment of the symptoms of BPH, prostate cancer, prostatitis or other diseases of the prostate. Pursuant to the agreement in 2010, the Company received an upfront license payment of $3.0 million. The Company has determined that the deliverables under this agreement included the license, the transfer of relevant technical information and participation in a periodic development meeting. The Company recognized the entire upfront license payment upon receipt as the license was deemed to have stand-alone value and no significant undelivered performance obligations were identified in connection with the license. | |
During the six months ended June 30, 2013, the Company recorded as revenue a $5.0 million non-refundable substantive milestone payment due from Kissei upon the achievement of certain development activities during this period. In accordance with the Company’s revenue recognition policy, the Company recognizes the receipt of milestone payments in accordance with the milestone method in the period in which the underlying triggering event occurs. |
Note_13_Purchase_Commitments
Note 13 - Purchase Commitments | 6 Months Ended | |
Jun. 30, 2014 | ||
Commitments and Contingencies Disclosure [Abstract] | ' | |
Commitments and Contingencies Disclosure [Text Block] | ' | |
13 | Purchase Commitments | |
The Company is required to schedule its manufacturing activities in advance. If the Company cancels any of these scheduled activities without proper notice the Company would be required to pay penalties equal to the cost of the originally scheduled activity. The Company estimates that the cost of these penalties would be approximately $0.1 million at June 30, 2014 if the Company cancels the scheduled activities. The amounts recorded under this manufacturing contract included in research and development was $0.8 million and $14,000 for the three months ended June 30, 2014 and 2013, respectively and $2.6 million and $0.9 million for the six months ended June 30, 2014 and 2013, respectively. |
Accounting_Policies_by_Policy_
Accounting Policies, by Policy (Policies) | 6 Months Ended | ||
Jun. 30, 2014 | |||
Accounting Policies [Abstract] | ' | ||
Consolidation, Policy [Policy Text Block] | ' | ||
Basis of consolidation | |||
The condensed consolidated financial statements include the accounts of the Company, Sophiris Bio Corp. and Sophiris Bio Holding Corp. All intercompany balances and transactions have been eliminated for purposes of consolidation. | |||
Basis of Accounting, Policy [Policy Text Block] | ' | ||
Basis of presentation and use of estimates | |||
The accompanying unaudited condensed consolidated financial statements have been prepared in conformity with generally accepted accounting principles in the United States, or GAAP, for the interim financial information and the rules and regulations of the Securities and Exchange Commission, or SEC, related to quarterly reports on Form 10-Q. Accordingly, they do not include all of the information and disclosures required by GAAP for annual audited financial statements and should be read in conjunction with the Company’s audited consolidated financial statements and notes thereto included in the Company’s Annual Report on Form 10-K, or Annual Report, filed with the SEC. The year-end condensed balance sheet data was derived from the audited consolidated financial statements, but does not include all disclosures required by GAAP. In the opinion of management, these condensed consolidated financial statements include all adjustments (consisting of normal recurring adjustments) necessary for a fair statement of the financial position, results of operations and cash flows for the periods presented. The results of operations for the interim periods shown in this report are not necessarily indicative of the results that may be expected for any future period, including the full year. | |||
GAAP requires the Company’s management to make estimates and judgments that may affect the reported amounts of assets, liabilities, revenue, expenses and related disclosures. The Company bases estimates and judgments on historical experience and on various other factors that it believes to be reasonable under the circumstances. The significant estimates in these condensed consolidated financial statements include revenue recognition, stock-based compensation expense, warrant liability, functional currency and accrued research and development expenses, including accruals related to the Company’s ongoing clinical trial. The Company’s actual results may differ from these estimates. The Company evaluates its estimates on an ongoing basis. Changes in estimates are reflected in reported results in the period in which they become known by the Company’s management. | |||
Foreign Currency Transactions and Translations Policy [Policy Text Block] | ' | ||
Foreign currency | |||
Gains and losses resulting from foreign currency translation are recorded in accumulated other comprehensive gain (loss), which is a separate component of stockholders’ equity. Foreign currency transaction gains and losses are recognized as a component of other income (expense), net. The Company recorded foreign exchange transaction losses of $29,000 and $45,000 for the three months and six months ended June 30, 2014, respectively, and $255,000 and $388,000 for the three and six months ended June 30, 2013, respectively. | |||
Cash and Cash Equivalents, Policy [Policy Text Block] | ' | ||
Cash and cash equivalents | |||
Cash equivalents are short-term, highly liquid investments with an original maturity of three months or less at the date of purchase. | |||
Marketable Securities, Policy [Policy Text Block] | ' | ||
Securities Available-for-Sale | |||
Investments with an original maturity of more than three months when purchased have been classified by management as securities available-for-sale. Such investments are carried at fair value, with unrealized gains and losses included as a component of accumulated other comprehensive gain (loss) in shareholders’ equity. Realized gains and losses on available-for-sale securities are included in interest income. No other-than-temporary impairments were identified for the investment securities held by the Company as of June 30, 2014 or December 31, 2013.The cost of investment securities classified as available-for-sale is adjusted for amortization of premiums and accretion of discounts to maturity. Such amortization and accretion are included in interest income. The cost of securities sold is based on the specific-identification method. The Company has classified all of its investment securities as available-for-sale, including those with maturities beyond one year, as current assets on the consolidated balance sheets based on the highly liquid nature of the investment securities and because these investment securities are considered available for use in current operations. | |||
Revenue Recognition, Policy [Policy Text Block] | ' | ||
Revenue recognition | |||
The Company may enter into product development agreements with collaborative partners for the research and development of products for the treatment of urological diseases. The terms of the agreements may include nonrefundable signing and licensing fees, milestone payments and royalties on any product sales derived from collaborations. These multiple element arrangements are analyzed to determine whether the deliverables can be separated or whether they must be accounted for as a single unit of accounting. License fees are recognized as revenue when persuasive evidence of an arrangement exists, the fee is fixed or determinable, delivery or performance has substantially completed and collection is reasonably assured. | |||
The Company recognizes up front license payments as revenue upon delivery of the license only if the license has stand-alone value to the customer and if the agreement includes a general right of return, the delivery or performance of undelivered items is considered probable and within the control of the Company. The payment is generally allocated to the separate units of accounting based on their relative selling prices. The selling price of each deliverable is determined using vendor specific objective evidence of selling prices, if it exists; otherwise, third-party evidence of selling prices. If neither vendor specific objective evidence nor third-party evidence exists, the Company uses its’ best estimate of the selling price for each deliverable. The payment allocated is limited to the amount that is not contingent on the delivery of additional items or fulfillment of other performance conditions. | |||
Whenever the Company determines that an arrangement should be accounted for as a single unit of accounting, it must determine the period over which the performance obligations will be performed and revenue recognized. If the Company cannot reasonably estimate the timing and the level of effort to complete its performance obligations under the arrangement, then revenue under the arrangement is recognized on a straight-line basis over the period the Company is expected to complete its performance obligations. | |||
The Company evaluates milestone payments on an individual basis and recognizes revenue from non-refundable milestone payments when the earnings process is complete and the payment is reasonably assured. Non-refundable milestone payments related to arrangements under which the Company has continuing performance obligations are recognized as revenue upon achievement of the associated milestone, provided that (i) the milestone event is substantive and its achievability was not reasonably assured at the inception of the agreement and (ii) the amount of the milestone payment is reasonable in relation to the effort expended or the risk associated with the milestone event. Any amounts received under agreements in advance of performance, if deemed substantive, are recorded as deferred revenue and recognized as revenue as the Company completes its performance obligations. A milestone event is considered substantive if (i) the milestone is commensurate with either (a) the Company’s performance to achieve the milestone or (b) the enhancement of the value of the delivered item(s) as a result of a specific outcome resulting from the Company’s performance to achieve the milestone; (ii) it relates solely to past performance and (iii) it is reasonable relative to all of the deliverables and payment terms (including other potential milestone consideration) within the arrangement. If any portion of the milestone payment does not relate to the Company’s performance, does not relate solely to past performance or is refundable or adjustable based on future performance, the milestone is not considered to be substantive. Milestone payments are not bifurcated into substantive and non-substantive components. Payments related to the achievement of non-substantive milestones is deferred and recognized over the Company’s remaining performance period. | |||
Royalty revenue will be recognized upon the sale of the related products provided the Company has no remaining performance obligations under the arrangement. | |||
Research and Development Expense, Policy [Policy Text Block] | ' | ||
Research and development expenses | |||
Research and development costs are charged to expense as incurred. Research and development expenses comprise costs incurred in performing research and development activities, including personnel-related costs, stock-based compensation, facilities, research-related overhead, clinical trial costs, contracted services, manufacturing, license fees and other external costs. The Company accounts for nonrefundable advance payments for goods and services that will be used in future research and development activities as expenses when the service has been performed or when the goods have been consumed rather than when the payment is made. | |||
Accrued Research and Development Expenses Policy [Policy Text Block] | ' | ||
Accrued research and development expenses | |||
Clinical trial costs are recorded as a component of research and development expenses. The Company accrues and expenses clinical trial activities performed by third parties based upon estimates of the percentage of work completed over the life of the individual study in accordance with agreements established with clinical research organizations and clinical trial sites. The Company determines the estimates through discussions with internal clinical personnel and external service providers as to the progress or stage of completion of trials or services and the agreed-upon fee to be paid for such services based on facts and circumstances known to the Company as of each balance sheet date. However, actual costs and timing of clinical trials are highly uncertain, subject to risks and may change depending upon a number of factors, including the Company’s clinical development plan. The process of estimating clinical trial costs may become more complex as the Company’s ongoing and planned Phase 3 clinical trials will involve larger numbers of patients and clinical sites. | |||
If the actual timing of the performance of services or the level of effort varies from the estimate, the Company will adjust the accrual accordingly. Adjustments to prior period estimates have not been material. | |||
Examples of estimated accrued research and development expenses include: | |||
• | fees paid to clinical research organizations in connection with clinical studies; | ||
• | fees paid to investigative sites in connection with clinical studies; | ||
• | fees paid to vendors in connection with preclinical development activities; | ||
• | fees paid to vendors associated with the development of companion diagnostics; and | ||
• | fees paid to vendors related to product manufacturing, development and distribution of clinical supplies. | ||
Nonrefundable advance payments for goods and services that will be used or rendered in future research and development activities, are recorded as a prepaid expense and recognized as expense in the period that the related goods are consumed or services are performed. | |||
Share-based Compensation, Option and Incentive Plans Policy [Policy Text Block] | ' | ||
Stock-based compensation | |||
The Company expenses the fair value of employee stock options over the vesting period. Compensation expense is measured using the fair value of the award at the grant date, net of estimated forfeitures, and is adjusted annually to reflect actual forfeitures. The fair value of each stock-based award is estimated using the Black-Scholes pricing model and is expensed using graded amortization over the vesting period. | |||
The Company accounts for stock options granted to non-employees, which primarily consist of members of the Company’s scientific advisory board and consultants, using the fair value approach. Stock options granted to non-employees are subject to revaluation each reporting period over their vesting terms. | |||
Historically the Company has issued its stock options with a Canadian dollar denominated exercise price. Subsequent to the Company’s initial public offering on the NASDAQ, the Company has issued its stock options with an U.S. dollar denominated exercise price. | |||
Effective November 13, 2013, the Company voluntarily delisted from the Toronto Stock Exchange, or TSX. Subsequent to November 13, 2013, the Company’s securities are being actively traded on only the NASDAQ. | |||
As a result of the delisting from the TSX and the change in the Company’s functional currency to the U.S. dollar, the stock options granted with exercise prices denominated in Canadian dollars are considered dual indexed as defined in ASC 718, “Compensation, Stock Compensation”. As a result of the stock options being dual indexed the Company is required to account for these stock options as a liability. Historically these options had been accounted for as equity. The estimated fair value is determined using the Black-Scholes pricing model based on the estimated value of the underlying common shares at the valuation measurement date, the remaining service period of the stock options, risk-free interest rates, expected dividends and expected volatility of the price of the underlying common shares. The fair value of the stock-based compensation liability was $84,000 at June 30, 2014. As the calculated fair value of the stock options at June 30, 2014 was less than the original grant date fair value no additional compensation expense was recorded in the consolidated statement of operations and comprehensive loss. The change in the fair value of the stock-based compensation liability for the three months ended June 30, 2014 of $98,000 and for the six months ended June 30, 2014 of $118,000 was recorded as an adjustment to Contributed Surplus. | |||
Fair Value Measurement, Policy [Policy Text Block] | ' | ||
Fair value of financial instruments | |||
The Company measures certain financial assets and liabilities at fair value based on the exchange price that would be received for an asset or paid for to transfer a liability (an exit price) in the principal or most advantageous market for the asset or liability in an orderly transaction between market participants. The carrying amounts of the Company’s financial instruments, including cash and cash equivalents and accounts payable and accrued expenses, approximate fair value due to their short maturities. | |||
The Company follows ASC 820-10, “Fair Value Measurements and Disclosures,” which among other things, 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 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, a three-tier fair value hierarchy has been established, which prioritizes the inputs used in measuring fair value as follows: | |||
Level 1 – Inputs are unadjusted, quoted prices in active markets for identical assets or liabilities at the measurement date. | |||
Level 2 – Inputs (other than quoted prices included in Level 1) are either directly or indirectly observable for the asset or liability through correlation with market data at the measurement date and for the duration of the instrument’s anticipated life. | |||
Level 3 – Inputs reflect management’s best estimate of what market participants would use in pricing the asset or liability at the measurement date. Consideration is given to the risk inherent in the valuation technique and the risk inherent in the inputs to the model. | |||
New Accounting Pronouncements, Policy [Policy Text Block] | ' | ||
Recent accounting pronouncements | |||
In May 2014, the FASB issued authoritative accounting guidance related to revenue from contracts with customers. This guidance is a comprehensive new revenue recognition model that requires a company to recognize revenue to depict the transfer of goods or services to a customer at an amount that reflects the consideration it expects to receive in exchange for those goods or services. This guidance is effective for annual reporting periods beginning after December 15, 2016 and early adoption is not permitted. The Company will adopt this guidance on January 1, 2017. Companies may use either a full retrospective or a modified retrospective approach to adopt this guidance. The Company is evaluating which transition approach to use and its impact, if any, on its consolidated financial statements |
Note_4_Net_Loss_per_Common_Sha1
Note 4 - Net Loss per Common Share (Tables) | 6 Months Ended | ||||||||
Jun. 30, 2014 | |||||||||
Earnings Per Share [Abstract] | ' | ||||||||
Schedule of Antidilutive Securities Excluded from Computation of Earnings Per Share [Table Text Block] | ' | ||||||||
30-Jun-14 | 30-Jun-13 | ||||||||
Options to purchase common shares | 1,386 | 301 | |||||||
Common share purchase warrants | 1,001 | 919 |
Note_5_Securities_Availablefor1
Note 5 - Securities Available-for-Sale (Tables) | 6 Months Ended | ||||||||||||||||
Jun. 30, 2014 | |||||||||||||||||
Investments, Debt and Equity Securities [Abstract] | ' | ||||||||||||||||
Available-for-sale Securities [Table Text Block] | ' | ||||||||||||||||
30-Jun-14 | |||||||||||||||||
Amortized | Unrealized | Estimated | |||||||||||||||
Cost | Gain | Loss | Fair Value | ||||||||||||||
Commercial paper | $ | 9,498 | $ | — | $ | — | $ | 9,498 | |||||||||
U.S. government sponsored enterprise securities | 2,006 | — | — | 2,006 | |||||||||||||
Corporate debt securities | 2,872 | 3 | — | 2,875 | |||||||||||||
$ | 14,376 | $ | 3 | $ | — | $ | 14,379 | ||||||||||
31-Dec-13 | |||||||||||||||||
Amortized | Unrealized | Estimated | |||||||||||||||
Cost | Gain | Loss | Fair Value | ||||||||||||||
Commercial paper | $ | 9,798 | $ | — | $ | — | $ | 9,798 | |||||||||
U.S. government sponsored enterprise securities | 17,007 | 2 | (4 | ) | 17,005 | ||||||||||||
Corporate debt securities | 6,506 | 2 | (1 | ) | 6,507 | ||||||||||||
$ | 33,311 | $ | 4 | $ | (5 | ) | $ | 33,310 | |||||||||
Investments Classified by Contractual Maturity Date [Table Text Block] | ' | ||||||||||||||||
30-Jun-14 | |||||||||||||||||
Amortized | Unrealized | Estimated | |||||||||||||||
Cost | Gain | Loss | Fair Value | ||||||||||||||
Within one year | $ | 9,498 | $ | — | $ | — | $ | 9,498 | |||||||||
After one year | 4,878 | 3 | — | 4,881 | |||||||||||||
$ | 14,376 | $ | 3 | $ | — | $ | 14,379 | ||||||||||
31-Dec-13 | |||||||||||||||||
Amortized | Unrealized | Estimated | |||||||||||||||
Cost | Gain | Loss | Fair Value | ||||||||||||||
Within one year | $ | 30,430 | $ | 2 | $ | (4 | ) | $ | 30,428 | ||||||||
After one year | 2,881 | 2 | (1 | ) | 2,882 | ||||||||||||
$ | 33,311 | $ | 4 | $ | (5 | ) | $ | 33,310 |
Note_6_Fair_Value_Measurement_1
Note 6 - Fair Value Measurement and Financial Instruments (Tables) | 6 Months Ended | ||||||||||||||||
Jun. 30, 2014 | |||||||||||||||||
Note 6 - Fair Value Measurement and Financial Instruments (Tables) [Line Items] | ' | ||||||||||||||||
Fair Value, Assets Measured on Recurring Basis [Table Text Block] | ' | ||||||||||||||||
30-Jun-14 | Level 1 | Level 2 | Level 3 | ||||||||||||||
Assets: | |||||||||||||||||
Money market funds | $ | 1,793 | $ | 1,793 | $ | — | $ | — | |||||||||
Commercial paper | 21,297 | — | 21,297 | — | |||||||||||||
U.S. government sponsored enterprise securities | 2,006 | — | 2,006 | — | |||||||||||||
Corporate debt securities | 2,875 | — | 2,875 | — | |||||||||||||
Total assets | $ | 27,971 | $ | 1,793 | $ | 26,178 | $ | — | |||||||||
Liabilities: | |||||||||||||||||
Warrant liability | $ | — | $ | — | $ | — | $ | — | |||||||||
Stock-based compensation liability | 84 | — | — | 84 | |||||||||||||
Total liabilities | $ | 84 | $ | — | $ | — | $ | 84 | |||||||||
31-Dec-13 | Level 1 | Level 2 | Level 3 | ||||||||||||||
Assets: | |||||||||||||||||
Money market funds | $ | 55 | $ | 55 | $ | — | $ | — | |||||||||
Commercial paper | 23,570 | — | 23,570 | — | |||||||||||||
U.S. government sponsored enterprise securities | 17,005 | — | 17,005 | — | |||||||||||||
Corporate debt securities | 6,507 | — | 6,507 | — | |||||||||||||
Total assets | $ | 47,137 | $ | 55 | $ | 47,082 | $ | — | |||||||||
Liabilities: | |||||||||||||||||
Warrant liability | $ | 883 | $ | — | $ | — | $ | 883 | |||||||||
Stock-based compensation liability | 202 | — | — | 202 | |||||||||||||
Total liabilities | $ | 1,085 | $ | — | $ | — | $ | 1,085 | |||||||||
Schedule of Share-based Payment Award, Stock Options, Valuation Assumptions [Table Text Block] | ' | ||||||||||||||||
Six Months Ended June 30, | |||||||||||||||||
2014 | 2013 | ||||||||||||||||
Expected life of the option term (years) | 3.7 | 4.2 | |||||||||||||||
Risk-free interest rate | 1.2 | % | 1.4 | % | |||||||||||||
Dividend rate | 0 | % | 0 | % | |||||||||||||
Volatility | 76.2 | % | 69.1 | % | |||||||||||||
Forfeiture rate | 5.3 | % | 8.8 | % | |||||||||||||
Warrant Liability [Member] | ' | ||||||||||||||||
Note 6 - Fair Value Measurement and Financial Instruments (Tables) [Line Items] | ' | ||||||||||||||||
Schedule of Share-based Payment Award, Stock Options, Valuation Assumptions [Table Text Block] | ' | ||||||||||||||||
30-Jun-14 | 31-Dec-13 | ||||||||||||||||
Stock price | $ | 2.24 | $ | 3.7 | |||||||||||||
Weighted average exercise price | $ | 31.68 | $ | 25.45 | |||||||||||||
Risk-free interest rate | 0.11 | % | 0.62 | % | |||||||||||||
Volatility | 51.24 | % | 115.09 | % | |||||||||||||
Dividend yield | 0 | % | 0 | % | |||||||||||||
Expected life in years | 0.71 | 2.51 | |||||||||||||||
Calculated fair value per common share purchase warrant | $ | - | $ | 0.96 | |||||||||||||
Condensed Cash Flow Statement [Table Text Block] | ' | ||||||||||||||||
Three Months Ended | Six Months Ended | ||||||||||||||||
30-Jun-14 | 30-Jun-14 | ||||||||||||||||
Liabilities: | |||||||||||||||||
Balance at beginning of period: | $ | 20 | $ | 883 | |||||||||||||
Reclassification of fair value of warrant liability to equity as a result of the amendment to convert the exercise price of certain warrants from Canadian dollars to U.S dollars of the underlying common share purchase warrants | - | (834 | ) | ||||||||||||||
Change in fair value of warrant liability included in other income (expense), net | (20 | ) | (49 | ) | |||||||||||||
Balance at end of period: | $ | - | $ | - | |||||||||||||
Stock-based Compensation Liability [Member] | ' | ||||||||||||||||
Note 6 - Fair Value Measurement and Financial Instruments (Tables) [Line Items] | ' | ||||||||||||||||
Schedule of Share-based Payment Award, Stock Options, Valuation Assumptions [Table Text Block] | ' | ||||||||||||||||
30-Jun-14 | 31-Dec-13 | ||||||||||||||||
Stock price | $ | 2.24 | $ | 3.7 | |||||||||||||
Weighted average exercise price | $ | 17.53 | $ | 17.66 | |||||||||||||
Risk-free interest rate | 0.85 | % | 1 | % | |||||||||||||
Volatility | 95.37 | % | 94.53 | % | |||||||||||||
Dividend yield | 0 | % | 0 | % | |||||||||||||
Expected life in years | 2.93 | 3.42 | |||||||||||||||
Calculated fair value per stock option | $ | 0.41 | $ | 1.17 | |||||||||||||
Condensed Cash Flow Statement [Table Text Block] | ' | ||||||||||||||||
Three Months Ended | Six Months Ended | ||||||||||||||||
30-Jun-14 | 30-Jun-14 | ||||||||||||||||
Liabilities: | |||||||||||||||||
Balance at beginning of period: | $ | 181 | $ | 202 | |||||||||||||
Change in fair value of stock-based compensation liability recorded as an adjustment to contributed surplus | (97 | ) | (118 | ) | |||||||||||||
Balance at end of period: | $ | 84 | $ | 84 |
Note_7_Prepaid_Expenses_Tables
Note 7 - Prepaid Expenses (Tables) | 6 Months Ended | ||||||||
Jun. 30, 2014 | |||||||||
Prepaid Expenses And Other Assets [Abstract] | ' | ||||||||
Schedule of Prepaid Expense and Other Current Assets [Table Text Block] | ' | ||||||||
June 30, | December 31, | ||||||||
2014 | 2013 | ||||||||
Prepaid insurance | $ | 81 | $ | 292 | |||||
Prepaid research and development expenses | 2,894 | 3,218 | |||||||
Other prepaid expenses | 34 | 88 | |||||||
$ | 3,009 | $ | 3,598 |
Note_8_Accrued_Expenses_Tables
Note 8 - Accrued Expenses (Tables) | 6 Months Ended | ||||||||
Jun. 30, 2014 | |||||||||
Payables and Accruals [Abstract] | ' | ||||||||
Schedule of Accounts Payable and Accrued Liabilities [Table Text Block] | ' | ||||||||
June 30, | December 31, | ||||||||
2014 | 2013 | ||||||||
Accrued personnel related costs | $ | 642 | $ | 1,063 | |||||
Accrued interest | - | 50 | |||||||
Accrued research and development expenses | 918 | 713 | |||||||
Other accrued expenses | 256 | 355 | |||||||
$ | 1,816 | $ | 2,181 |
Note_9_Promissory_Notes_Tables
Note 9 - Promissory Notes (Tables) | 6 Months Ended | ||||||||||||||||
Jun. 30, 2014 | |||||||||||||||||
Debt Disclosure [Abstract] | ' | ||||||||||||||||
Schedule of Maturities of Long-term Debt [Table Text Block] | ' | ||||||||||||||||
2014 | $ | — | |||||||||||||||
2015 | 735 | ||||||||||||||||
2016 | 1,887 | ||||||||||||||||
2017 | 2,074 | ||||||||||||||||
2018 | 1,604 | ||||||||||||||||
Total | $ | 6,300 | |||||||||||||||
Contractual Interest Expense and Amortization of Debt Issuance Costs and Debt Discount [Table Text Block] | ' | ||||||||||||||||
Three Months Ended June 30, | Six Months Ended June 30, | ||||||||||||||||
2014 | 2013 | 2014 | 2013 | ||||||||||||||
Simple interest | $ | 92 | $ | 224 | $ | 215 | $ | 482 | |||||||||
Accretion of debt discount | 55 | 99 | 123 | 208 | |||||||||||||
Amortization of promissory notes issuance costs | 21 | 29 | 38 | 61 | |||||||||||||
$ | 168 | $ | 352 | $ | 376 | $ | 751 |
Note_11_Stockbased_Compensatio1
Note 11 - Stock-based Compensation Plan (Tables) | 6 Months Ended | ||||||||||||||||
Jun. 30, 2014 | |||||||||||||||||
Disclosure of Compensation Related Costs, Share-based Payments [Abstract] | ' | ||||||||||||||||
Schedule of Employee Service Share-based Compensation, Allocation of Recognized Period Costs [Table Text Block] | ' | ||||||||||||||||
Three Months Ended June 30, | Six Months Ended June 30, | ||||||||||||||||
2014 | 2013 | 2014 | 2013 | ||||||||||||||
Research and development | $ | 153 | $ | 60 | $ | 346 | $ | 124 | |||||||||
General and administrative | 391 | 213 | 807 | 401 | |||||||||||||
Total | $ | 544 | $ | 273 | $ | 1,153 | $ | 525 | |||||||||
Schedule of Share-based Payment Award, Stock Options, Valuation Assumptions [Table Text Block] | ' | ||||||||||||||||
Six Months Ended June 30, | |||||||||||||||||
2014 | 2013 | ||||||||||||||||
Expected life of the option term (years) | 3.7 | 4.2 | |||||||||||||||
Risk-free interest rate | 1.2 | % | 1.4 | % | |||||||||||||
Dividend rate | 0 | % | 0 | % | |||||||||||||
Volatility | 76.2 | % | 69.1 | % | |||||||||||||
Forfeiture rate | 5.3 | % | 8.8 | % | |||||||||||||
Schedule of Share-based Compensation, Stock Options, Activity [Table Text Block] | ' | ||||||||||||||||
Options | Weighted | Currency | |||||||||||||||
outstanding | average | ||||||||||||||||
exercise | |||||||||||||||||
price | |||||||||||||||||
Outstanding at January 1, 2014 | 1,362 | $ | 7.1 | US | |||||||||||||
Options granted | 87 | 2.57 | US | ||||||||||||||
Options forfeited | (9 | ) | 4.17 | CND | |||||||||||||
Options forfeited | (54 | ) | 3.79 | US | |||||||||||||
Outstanding at June 30, 2014 | 1,386 | $ | 3.51 | US |
Note_3_Summary_of_Significant_1
Note 3 - Summary of Significant Accounting Policies (Details) (USD $) | 3 Months Ended | 6 Months Ended | ||
Jun. 30, 2014 | Jun. 30, 2013 | Jun. 30, 2014 | Jun. 30, 2013 | |
Note 3 - Summary of Significant Accounting Policies (Details) [Line Items] | ' | ' | ' | ' |
Foreign Currency Transaction Gain (Loss), before Tax | ' | ' | ($11,000) | ($388,000) |
Fair Value of Stock-based Compensation Liability for Stock Options | 84,000 | ' | 84,000 | ' |
Change in Fair Value of Stock-based Compensation Liability | 98,000 | ' | 118,000 | ' |
Other Income (Expense), Net [Member] | ' | ' | ' | ' |
Note 3 - Summary of Significant Accounting Policies (Details) [Line Items] | ' | ' | ' | ' |
Foreign Currency Transaction Gain (Loss), before Tax | ($29,000) | ($255,000) | ($45,000) | ($388,000) |
Note_4_Net_Loss_per_Common_Sha2
Note 4 - Net Loss per Common Share (Details) - Potentially Dilutive Securities Excluded from Diluted Weighted-Avg. Shares Outstanding | 6 Months Ended | |
In Thousands, unless otherwise specified | Jun. 30, 2014 | Jun. 30, 2013 |
Equity Option [Member] | ' | ' |
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] | ' | ' |
Anti-dilutive securities excluded from computation of weighted-average shares outstanding | 1,386 | 301 |
Warrant [Member] | ' | ' |
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] | ' | ' |
Anti-dilutive securities excluded from computation of weighted-average shares outstanding | 1,001 | 919 |
Note_5_Securities_Availablefor2
Note 5 - Securities Available-for-Sale (Details) - Securities Available-for-Sale (USD $) | 6 Months Ended | 12 Months Ended |
In Thousands, unless otherwise specified | Jun. 30, 2014 | Dec. 31, 2013 |
Schedule of Available-for-sale Securities [Line Items] | ' | ' |
Amortized Cost | $14,376 | $33,311 |
Unrealized Gain | 3 | 4 |
Unrealized Loss | ' | -5 |
Estimated Fair Value | 14,379 | 33,310 |
Commercial Paper, Not Included with Cash and Cash Equivalents [Member] | ' | ' |
Schedule of Available-for-sale Securities [Line Items] | ' | ' |
Amortized Cost | 9,498 | 9,798 |
Estimated Fair Value | 9,498 | 9,798 |
US Government-sponsored Enterprises Debt Securities [Member] | ' | ' |
Schedule of Available-for-sale Securities [Line Items] | ' | ' |
Amortized Cost | 2,006 | 17,007 |
Unrealized Gain | ' | 2 |
Unrealized Loss | ' | -4 |
Estimated Fair Value | 2,006 | 17,005 |
Corporate Debt Securities [Member] | ' | ' |
Schedule of Available-for-sale Securities [Line Items] | ' | ' |
Amortized Cost | 2,872 | 6,506 |
Unrealized Gain | 3 | 2 |
Unrealized Loss | ' | -1 |
Estimated Fair Value | $2,875 | $6,507 |
Note_5_Securities_Availablefor3
Note 5 - Securities Available-for-Sale (Details) - Amortized Cost and Estimated Fair Value of Securities (USD $) | 6 Months Ended | 12 Months Ended |
In Thousands, unless otherwise specified | Jun. 30, 2014 | Dec. 31, 2013 |
Note 5 - Securities Available-for-Sale (Details) - Amortized Cost and Estimated Fair Value of Securities [Line Items] | ' | ' |
Amortized Cost | $14,376 | $33,311 |
Unrealized Gain | 3 | 4 |
Unrealized Loss | ' | -5 |
Estimated Fair Value | 14,379 | 33,310 |
Within One Year [Member] | ' | ' |
Note 5 - Securities Available-for-Sale (Details) - Amortized Cost and Estimated Fair Value of Securities [Line Items] | ' | ' |
Amortized Cost | 9,498 | 30,430 |
Unrealized Gain | ' | 2 |
Unrealized Loss | ' | -4 |
Estimated Fair Value | 9,498 | 30,428 |
After One Year [Member] | ' | ' |
Note 5 - Securities Available-for-Sale (Details) - Amortized Cost and Estimated Fair Value of Securities [Line Items] | ' | ' |
Amortized Cost | 4,878 | 2,881 |
Unrealized Gain | 3 | 2 |
Unrealized Loss | ' | -1 |
Estimated Fair Value | $4,881 | $2,882 |
Note_6_Fair_Value_Measurement_2
Note 6 - Fair Value Measurement and Financial Instruments (Details) (USD $) | Jun. 30, 2014 | Dec. 31, 2013 |
In Thousands, unless otherwise specified | ||
Fair Value Disclosures [Abstract] | ' | ' |
Assets, Fair Value Disclosure, Recurring | $27,971 | $47,137 |
Note_6_Fair_Value_Measurement_3
Note 6 - Fair Value Measurement and Financial Instruments (Details) - Assets and Liabilities Measured at Fair Value Measured on a Recurring Basis (USD $) | Jun. 30, 2014 | Dec. 31, 2013 |
In Thousands, unless otherwise specified | ||
Assets: | ' | ' |
Asset Fair Value | $27,971 | $47,137 |
Liabilities: | ' | ' |
Liability Fair Value | 84 | 1,085 |
Warrant Liability [Member] | Fair Value, Inputs, Level 3 [Member] | ' | ' |
Liabilities: | ' | ' |
Liability Fair Value | ' | 883 |
Warrant Liability [Member] | ' | ' |
Liabilities: | ' | ' |
Liability Fair Value | ' | 883 |
Stock-based Compensation Liability [Member] | Fair Value, Inputs, Level 3 [Member] | ' | ' |
Liabilities: | ' | ' |
Liability Fair Value | 84 | 202 |
Stock-based Compensation Liability [Member] | ' | ' |
Liabilities: | ' | ' |
Liability Fair Value | 84 | 202 |
Fair Value, Inputs, Level 1 [Member] | Money Market Funds [Member] | ' | ' |
Assets: | ' | ' |
Asset Fair Value | 1,793 | 55 |
Fair Value, Inputs, Level 1 [Member] | ' | ' |
Assets: | ' | ' |
Asset Fair Value | 1,793 | 55 |
Fair Value, Inputs, Level 2 [Member] | Commercial Paper [Member] | ' | ' |
Assets: | ' | ' |
Asset Fair Value | 21,297 | 23,570 |
Fair Value, Inputs, Level 2 [Member] | US Government-sponsored Enterprises Debt Securities [Member] | ' | ' |
Assets: | ' | ' |
Asset Fair Value | 2,006 | 17,005 |
Fair Value, Inputs, Level 2 [Member] | Corporate Debt Securities [Member] | ' | ' |
Assets: | ' | ' |
Asset Fair Value | 2,875 | 6,507 |
Fair Value, Inputs, Level 2 [Member] | ' | ' |
Assets: | ' | ' |
Asset Fair Value | 26,178 | 47,082 |
Fair Value, Inputs, Level 3 [Member] | ' | ' |
Liabilities: | ' | ' |
Liability Fair Value | 84 | 1,085 |
Money Market Funds [Member] | ' | ' |
Assets: | ' | ' |
Asset Fair Value | 1,793 | 55 |
Commercial Paper [Member] | ' | ' |
Assets: | ' | ' |
Asset Fair Value | 21,297 | 23,570 |
US Government-sponsored Enterprises Debt Securities [Member] | ' | ' |
Assets: | ' | ' |
Asset Fair Value | 2,006 | 17,005 |
Corporate Debt Securities [Member] | ' | ' |
Assets: | ' | ' |
Asset Fair Value | $2,875 | $6,507 |
Note_6_Fair_Value_Measurement_4
Note 6 - Fair Value Measurement and Financial Instruments (Details) - Fair Value Assumptions, Warrant Liability (Warrant Liability [Member], USD $) | 6 Months Ended | 12 Months Ended |
Jun. 30, 2014 | Dec. 31, 2013 | |
Warrant Liability [Member] | ' | ' |
Note 6 - Fair Value Measurement and Financial Instruments (Details) - Fair Value Assumptions, Warrant Liability [Line Items] | ' | ' |
Stock price (in Dollars per share) | $2.24 | $3.70 |
Weighted average exercise price (in Dollars per share) | $31.68 | $25.45 |
Risk-free interest rate | 0.11% | 0.62% |
Volatility | 51.24% | 115.09% |
Dividend yield | 0.00% | 0.00% |
Expected life in years | '259 days | '2 years 186 days |
Calculated fair value per common share purchase warrant (in Dollars per share) | ' | $0.96 |
Note_6_Fair_Value_Measurement_5
Note 6 - Fair Value Measurement and Financial Instruments (Details) - Fair Value Assumptions, Stock-based Compensation Liability (Stock-based Compensation Liability [Member], USD $) | 6 Months Ended | 12 Months Ended |
Jun. 30, 2014 | Dec. 31, 2013 | |
Stock-based Compensation Liability [Member] | ' | ' |
Note 6 - Fair Value Measurement and Financial Instruments (Details) - Fair Value Assumptions, Stock-based Compensation Liability [Line Items] | ' | ' |
Stock price | $2.24 | $3.70 |
Weighted average exercise price | $17.53 | $17.66 |
Risk-free interest rate | 0.85% | 1.00% |
Volatility | 95.37% | 94.53% |
Dividend yield | 0.00% | 0.00% |
Expected life in years | '2 years 339 days | '3 years 153 days |
Calculated fair value per stock option | $0.41 | $1.17 |
Note_6_Fair_Value_Measurement_6
Note 6 - Fair Value Measurement and Financial Instruments (Details) - Fair Value Reconciliation of Warrant Liability (Warrant Liability [Member], USD $) | 3 Months Ended | 6 Months Ended |
In Thousands, unless otherwise specified | Jun. 30, 2014 | Jun. 30, 2014 |
Warrant Liability [Member] | ' | ' |
Condensed Cash Flow Statements, Captions [Line Items] | ' | ' |
Balance at beginning of period: | $20 | $883 |
Reclassification of fair value of warrant liability to equity as a result of the amendment to convert the exercise price of certain warrants from Canadian dollars to U.S dollars of the underlying common share purchase warrants | ' | -834 |
Change in fair value of warrant liability included in other income (expense), net | ($20) | ($49) |
Note_6_Fair_Value_Measurement_7
Note 6 - Fair Value Measurement and Financial Instruments (Details) - Fair Value Reconciliation of Stock-based Compensation Liability (USD $) | 3 Months Ended | 6 Months Ended |
Jun. 30, 2014 | Jun. 30, 2014 | |
Condensed Cash Flow Statements, Captions [Line Items] | ' | ' |
Change in fair value of stock-based compensation liability recorded as an adjustment to contributed surplus | $98,000 | $118,000 |
Stock-based Compensation Liability [Member] | ' | ' |
Condensed Cash Flow Statements, Captions [Line Items] | ' | ' |
Balance at beginning of period: | 181,000 | 202,000 |
Change in fair value of stock-based compensation liability recorded as an adjustment to contributed surplus | -97,000 | -118,000 |
Balance at end of period: | $84,000 | $84,000 |
Note_7_Prepaid_Expenses_Detail
Note 7 - Prepaid Expenses (Details) (USD $) | 6 Months Ended | 12 Months Ended |
In Millions, unless otherwise specified | Jun. 30, 2014 | Dec. 31, 2013 |
Prepaid Expenses And Other Assets [Abstract] | ' | ' |
Upfront Fees Included in Prepaid Research and Development Expenses | $2.60 | $2.70 |
Note_7_Prepaid_Expenses_Detail1
Note 7 - Prepaid Expenses (Details) - Components of Prepaid Expenses (USD $) | Jun. 30, 2014 | Dec. 31, 2013 |
In Thousands, unless otherwise specified | ||
Components of Prepaid Expenses [Abstract] | ' | ' |
Prepaid insurance | $81 | $292 |
Prepaid research and development expenses | 2,894 | 3,218 |
Other prepaid expenses | 34 | 88 |
$3,009 | $3,598 |
Note_8_Accrued_Expenses_Detail
Note 8 - Accrued Expenses (Details) - Components of Accrued Expenses (USD $) | Jun. 30, 2014 | Dec. 31, 2013 |
In Thousands, unless otherwise specified | ||
Components of Accrued Expenses [Abstract] | ' | ' |
Accrued personnel related costs | $642 | $1,063 |
Accrued interest | ' | 50 |
Accrued research and development expenses | 918 | 713 |
Other accrued expenses | 256 | 355 |
$1,816 | $2,181 |
Note_9_Promissory_Notes_Detail
Note 9 - Promissory Notes (Details) (USD $) | 6 Months Ended | 3 Months Ended | 3 Months Ended | 6 Months Ended | |||||
Jun. 30, 2014 | Jun. 30, 2014 | Jun. 30, 2014 | Jul. 15, 2011 | Jun. 30, 2014 | Jun. 30, 2014 | Jun. 30, 2014 | Jun. 30, 2014 | Jun. 30, 2014 | |
Fair Value, Inputs, Level 3 [Member] | Oxford Loan [Member] | Oxford Loan [Member] | Oxford New Loan [Member] | Oxford New Loan [Member] | Oxford New Loan [Member] | Oxford New Loan [Member] | Oxford New Loan [Member] | ||
Oxford New Loan [Member] | Warrants Not Settleable in Cash [Member] | Minimum [Member] | Maximum [Member] | ||||||
Note 9 - Promissory Notes (Details) [Line Items] | ' | ' | ' | ' | ' | ' | ' | ' | ' |
Debt Instrument, Face Amount (in Dollars) | ' | ' | ' | $15,000,000 | ' | $6,000,000 | $6,000,000 | ' | ' |
Debt Instrument, Interest Rate, Stated Percentage | ' | ' | ' | 9.50% | ' | 9.50% | 9.50% | ' | ' |
Additional Fee, Percentage | ' | ' | ' | 5.00% | ' | 5.00% | 5.00% | ' | ' |
Repayments of Debt (in Dollars) | ' | ' | 2,900,000 | ' | ' | ' | ' | ' | ' |
Debt Instrument, Periodic Payment Terms, Balloon Payment to be Paid (in Dollars) | ' | ' | 700,000 | ' | ' | ' | ' | ' | ' |
Proceeds from Issuance of Debt (in Dollars) | 2,362,000 | ' | ' | ' | ' | 2,300,000 | ' | ' | ' |
Prepayment Fee Rate | ' | ' | ' | ' | ' | ' | ' | 1.00% | 3.00% |
Debt Instrument, Term | ' | ' | ' | ' | ' | ' | '36 months | ' | ' |
Class of Warrant or Right, Number of Securities Called by Warrants or Rights (in Shares) | ' | ' | ' | ' | ' | 82,192 | 82,192 | ' | ' |
Class of Warrant or Right, Exercise Price of Warrants or Rights (in Dollars per share) | ' | ' | ' | ' | ' | $2.19 | $2.19 | ' | ' |
Warrant Term | ' | ' | ' | ' | ' | '7 years | ' | ' | ' |
Warrants Not Settleable in Cash, Fair Value Disclosure (in Dollars) | ' | ' | ' | ' | ' | 100,000 | 100,000 | ' | ' |
Fair Value Assumptions, Risk Free Interest Rate | ' | ' | ' | ' | 2.10% | ' | ' | ' | ' |
Fair Value Assumptions, Expected Volatility Rate | ' | ' | ' | ' | 72.10% | ' | ' | ' | ' |
Fair Value Assumptions, Expected Dividend Rate | ' | ' | ' | ' | 0.00% | ' | ' | ' | ' |
Fair Value Assumptions, Expected Term | ' | ' | ' | ' | '7 years | ' | ' | ' | ' |
Long-term Debt, Fair Value (in Dollars) | ' | 5,900,000 | ' | ' | ' | ' | ' | ' | ' |
Debt Issuance Cost (in Dollars) | ' | ' | ' | ' | ' | $100,000 | ' | ' | ' |
Note_9_Promissory_Notes_Detail1
Note 9 - Promissory Notes (Details) - Future Contractual Principal and Final Fee Payments (USD $) | Jun. 30, 2014 |
In Thousands, unless otherwise specified | |
Future Contractual Principal and Final Fee Payments [Abstract] | ' |
2014 | $0 |
2015 | 735 |
2016 | 1,887 |
2017 | 2,074 |
2018 | 1,604 |
Total | $6,300 |
Note_9_Promissory_Notes_Detail2
Note 9 - Promissory Notes (Details) - Actual Interest Expense and Amortization of Debt Discount (USD $) | 3 Months Ended | 6 Months Ended | ||
In Thousands, unless otherwise specified | Jun. 30, 2014 | Jun. 30, 2013 | Jun. 30, 2014 | Jun. 30, 2013 |
Actual Interest Expense and Amortization of Debt Discount [Abstract] | ' | ' | ' | ' |
Simple interest | $92 | $224 | $215 | $482 |
Accretion of debt discount | 55 | 99 | 123 | 208 |
Amortization of promissory notes issuance costs | 21 | 29 | 38 | 61 |
$168 | $352 | $376 | $751 |
Note_10_Common_Stock_Purchase_1
Note 10 - Common Stock Purchase Agreement with Aspire Capital (Details) (Aspire Capital [Member], USD $) | 1 Months Ended | 0 Months Ended | 6 Months Ended |
In Millions, except Share data, unless otherwise specified | Aug. 07, 2014 | 16-May-14 | Jun. 30, 2014 |
Subsequent Event [Member] | |||
Note 10 - Common Stock Purchase Agreement with Aspire Capital (Details) [Line Items] | ' | ' | ' |
Common Stock, Value, Subscriptions | ' | $15 | ' |
Common Stock Purchase Agreement Term | ' | '30 months | ' |
Development Stage Entities, Stock Issued, Shares, Issued for Noncash Consideration (in Shares) | ' | 90,635 | ' |
Stock Issued During Period, Shares, New Issues (in Shares) | 0 | 604,230 | ' |
Share Price (in Dollars per share) | ' | $3.31 | ' |
Proceeds from Issuance of Common Stock | ' | 1.9 | ' |
Issuance Cost for Purchase Agreement | ' | 0.1 | ' |
Minimum Price Per Share To Retain Stock Purchase Direction Right (in Dollars per share) | ' | ' | $2 |
Additional Common Shares To Be Purchased At Reporting Entity's Direction, Value | ' | ' | $13 |
Note_11_Stockbased_Compensatio2
Note 11 - Stock-based Compensation Plan (Details) (USD $) | 6 Months Ended |
In Millions, unless otherwise specified | Jun. 30, 2014 |
Disclosure of Compensation Related Costs, Share-based Payments [Abstract] | ' |
Employee Service Share-based Compensation, Nonvested Awards, Compensation Cost Not yet Recognized | $1.50 |
Employee Service Share-based Compensation, Nonvested Awards, Compensation Cost Not yet Recognized, Period for Recognition | '1 year 73 days |
Note_11_Stockbased_Compensatio3
Note 11 - Stock-based Compensation Plan (Details) - Stock-based Compensation Expense (USD $) | 3 Months Ended | 6 Months Ended | ||
In Thousands, unless otherwise specified | Jun. 30, 2014 | Jun. 30, 2013 | Jun. 30, 2014 | Jun. 30, 2013 |
Share-based Compensation Arrangement by Share-based Payment Award, Compensation Cost [Line Items] | ' | ' | ' | ' |
Stock-based compensation expense | $544 | $273 | $1,153 | $525 |
Research and Development Expense [Member] | ' | ' | ' | ' |
Share-based Compensation Arrangement by Share-based Payment Award, Compensation Cost [Line Items] | ' | ' | ' | ' |
Stock-based compensation expense | 153 | 60 | 346 | 124 |
General and Administrative Expense [Member] | ' | ' | ' | ' |
Share-based Compensation Arrangement by Share-based Payment Award, Compensation Cost [Line Items] | ' | ' | ' | ' |
Stock-based compensation expense | $391 | $213 | $807 | $401 |
Note_11_Stockbased_Compensatio4
Note 11 - Stock-based Compensation Plan (Details) - Fair Value of Options Granted | 6 Months Ended | |
Jun. 30, 2014 | Jun. 30, 2013 | |
Fair Value of Options Granted [Abstract] | ' | ' |
Expected life of the option term (years) | '3 years 255 days | '4 years 73 days |
Risk-free interest rate | 1.20% | 1.40% |
Dividend rate | 0.00% | 0.00% |
Volatility | 76.20% | 69.10% |
Forfeiture rate | 5.30% | 8.80% |
Note_11_Stockbased_Compensatio5
Note 11 - Stock-based Compensation Plan (Details) - Stock Option Activity | 6 Months Ended | ||
In Thousands, except Per Share data, unless otherwise specified | Jun. 30, 2014 | Jun. 30, 2014 | Jun. 30, 2014 |
USD ($) | Canada, Dollars | United States of America, Dollars | |
CAD | USD ($) | ||
Note 11 - Stock-based Compensation Plan (Details) - Stock Option Activity [Line Items] | ' | ' | ' |
Outstanding at January 1, 2014 | 1,362 | ' | ' |
Outstanding at January 1, 2014 (in Dollars per share) | $7.10 | ' | ' |
Options granted | 87 | ' | ' |
Options granted (in Dollars per share) | $2.57 | ' | ' |
Options forfeited | ' | -9 | -54 |
Options forfeited (in Dollars per share) | ' | 4.17 | $3.79 |
Options forfeited | ' | -9 | -54 |
Options forfeited (in Dollars per share) | ' | 4.17 | $3.79 |
Outstanding at June 30, 2014 | 1,386 | ' | ' |
Outstanding at June 30, 2014 (in Dollars per share) | $3.51 | ' | ' |
Note_12_Kissei_Agreement_Detai
Note 12 - Kissei Agreement (Details) (Kissei Pharmaceuticals Co. Ltd. [Member], USD $) | 1 Months Ended | 6 Months Ended |
In Millions, unless otherwise specified | Apr. 30, 2010 | Jun. 30, 2013 |
Kissei Pharmaceuticals Co. Ltd. [Member] | ' | ' |
Note 12 - Kissei Agreement (Details) [Line Items] | ' | ' |
Upfront Payment Related to Licensing Agreement | $3 | ' |
Revenue Recognition, Milestone Method, Revenue Recognized | ' | $5 |
Note_13_Purchase_Commitments_D
Note 13 - Purchase Commitments (Details) (USD $) | 3 Months Ended | 6 Months Ended | ||
Jun. 30, 2014 | Jun. 30, 2013 | Jun. 30, 2014 | Jun. 30, 2013 | |
Note 13 - Purchase Commitments (Details) [Line Items] | ' | ' | ' | ' |
Purchase Commitment Estimated Penalties | $100,000 | ' | $100,000 | ' |
Research and Development Arrangement [Member] | ' | ' | ' | ' |
Note 13 - Purchase Commitments (Details) [Line Items] | ' | ' | ' | ' |
Long-term Purchase Commitment, Amount | $800,000 | $14,000 | $2,600,000 | $900,000 |