Document_and_Entity_Informatio
Document and Entity Information | 6 Months Ended | |
Jun. 30, 2014 | Aug. 05, 2014 | |
Document and Entity Information | ' | ' |
Entity Registrant Name | 'KALOBIOS PHARMACEUTICALS INC | ' |
Entity Central Index Key | '0001293310 | ' |
Document Type | '10-Q | ' |
Document Period End Date | 30-Jun-14 | ' |
Amendment Flag | 'false | ' |
Current Fiscal Year End Date | '--12-31 | ' |
Entity Voluntary Filers | 'Yes | ' |
Entity Filer Category | 'Accelerated Filer | ' |
Entity Common Stock, Shares Outstanding | ' | 32,987,817 |
Document Fiscal Year Focus | '2014 | ' |
Document Fiscal Period Focus | 'Q2 | ' |
Condensed_Consolidated_Balance
Condensed Consolidated Balance Sheets (USD $) | Jun. 30, 2014 | Dec. 31, 2013 |
In Thousands, unless otherwise specified | ||
Current assets: | ' | ' |
Cash and cash equivalents | $9,053 | $54,220 |
Marketable securities | 48,981 | 22,511 |
Prepaid expenses and other current assets | 1,698 | 786 |
Restricted cash | 205 | 205 |
Total current assets | 59,937 | 77,722 |
Marketable securities, non-current | 752 | ' |
Property and equipment, net | 334 | 276 |
Restricted cash | 193 | ' |
Other assets | 121 | 706 |
Total assets | 61,337 | 78,704 |
Current liabilities: | ' | ' |
Accounts payable | 2,658 | 3,197 |
Accrued compensation | 1,009 | 1,091 |
Accrued research and clinical liabilities | 2,208 | 3,309 |
Notes payable, short-term | 5,131 | 3,182 |
Other accrued liabilities | 492 | 603 |
Total current liabilities | 11,498 | 11,382 |
Notes payable, long-term | 8,292 | 6,786 |
Deferred rent, long-term | 157 | ' |
Total liabilities | 19,947 | 18,168 |
Commitments and contingencies (Note 7) | ' | ' |
Stockholders' equity (deficit): | ' | ' |
Common stock, $0.001 par value: 85,000,000 shares and 47,500,000 shares authorized at June 30, 2014, and December 31, 2013 respectively; 32,981,396 and 32,931,092 shares issued and outstanding at June 30,2014, and December 31, 2013, respectively | 33 | 33 |
Additional paid-in capital | 201,793 | 200,715 |
Accumulated other comprehensive income | 1 | 3 |
Accumulated deficit | -160,437 | -140,215 |
Total stockholders' equity | 41,390 | 60,536 |
Total liabilities and stockholders' equity | $61,337 | $78,704 |
Condensed_Consolidated_Balance1
Condensed Consolidated Balance Sheets (Parenthetical) (USD $) | Jun. 30, 2014 | Dec. 31, 2013 |
Condensed Consolidated Balance Sheets | ' | ' |
Common stock, par value | $0.00 | $0.00 |
Common stock, shares authorized | 85,000,000 | 47,500,000 |
Common stock, shares issued | 32,981,396 | 32,931,092 |
Common stock, shares outstanding | 32,981,396 | 32,931,092 |
Condensed_Consolidated_Stateme
Condensed Consolidated Statements of Comprehensive Loss (USD $) | 3 Months Ended | 6 Months Ended | ||
In Thousands, except Share data, unless otherwise specified | Jun. 30, 2014 | Jun. 30, 2013 | Jun. 30, 2014 | Jun. 30, 2013 |
Condensed Consolidated Statements of Comprehensive Loss | ' | ' | ' | ' |
Contract revenue | ' | $15 | ' | $31 |
Operating expenses: | ' | ' | ' | ' |
Research and development | 6,721 | 9,646 | 14,411 | 15,966 |
General and administrative | 2,813 | 1,940 | 5,283 | 3,959 |
Total operating expenses | 9,534 | 11,586 | 19,694 | 19,925 |
Loss from operations | -9,534 | -11,571 | -19,694 | -19,894 |
Other income (expense): | ' | ' | ' | ' |
Interest income, net | -290 | -236 | -550 | -488 |
Other income (expense), net | 10 | -2 | 22 | -1 |
Net loss | -9,814 | -11,809 | -20,222 | -20,383 |
Other comprehensive income (loss): | ' | ' | ' | ' |
Net unrealized gains (losses) on marketable securities | 2 | 17 | -2 | 17 |
Comprehensive loss | ($9,812) | ($11,792) | ($20,224) | ($20,366) |
Basic and diluted net loss per common share (in dollars per share) | ($0.30) | ($0.49) | ($0.61) | ($1.02) |
Weighted average common shares outstanding used to calculate basic and diluted net loss per common share (in shares) | 32,981,396 | 24,189,819 | 32,973,892 | 19,922,307 |
Condensed_Consolidated_Stateme1
Condensed Consolidated Statements of Cash Flows (USD $) | 6 Months Ended | |
In Thousands, unless otherwise specified | Jun. 30, 2014 | Jun. 30, 2013 |
Operating activities: | ' | ' |
Net loss | ($20,222) | ($20,383) |
Adjustments to reconcile net loss to net cash used in operating activities: | ' | ' |
Depreciation and amortization | 230 | 85 |
Noncash interest expense | 101 | 76 |
Amortization of premium on marketable securities | 217 | 218 |
Stock based compensation expense | 1,018 | 554 |
Changes in operating assets and liabilities: | ' | ' |
Prepaid expenses and other assets | -351 | -1,044 |
Accounts payable | -540 | 1,402 |
Accrued compensation | -81 | -146 |
Accrued research and clinical liabilities | -1,101 | -1,069 |
Other liabilities | 49 | -68 |
Deferred rent | -3 | -29 |
Net cash used in operating activities | -20,683 | -20,404 |
Investing activities: | ' | ' |
Purchase of marketable securities | -49,902 | -39,731 |
Proceeds from maturities of marketable securities | 22,460 | 4,705 |
Purchases of property and equipment | -287 | -23 |
Changes in restricted cash | -193 | ' |
Net cash used in investing activities | -27,922 | -35,049 |
Financing activities: | ' | ' |
Proceeds from initial public offering, net of offering costs | ' | 63,912 |
Proceeds from issuances of debt | 5,000 | ' |
Proceeds from issuance of common stock | 59 | 68 |
Principal payments under notes payable | -1,621 | ' |
Net cash provided by financing activities | 3,438 | 63,980 |
Net (decrease) increase in cash and cash equivalents | -45,167 | 8,527 |
Cash and cash equivalents, beginning of period | 54,220 | 10,947 |
Cash and cash equivalents, end of period | 9,053 | 19,474 |
Supplemental cash flow disclosure: | ' | ' |
Cash paid for interest | 425 | 453 |
Supplemental disclosure of noncash financing activities: | ' | ' |
Conversion of preferred stock to common stock and additional paid-in capital | ' | 102,023 |
Reclassification of preferred stock warrants liability to additional paid-in capital | ' | 157 |
Issuance of common stock warrants in connection with a loan amendment | ' | $130 |
Nature_of_Operations
Nature of Operations | 6 Months Ended |
Jun. 30, 2014 | |
Nature of Operations | ' |
Nature of Operations | ' |
1. Nature of Operations | |
KaloBios Pharmaceuticals, Inc. (the Company) is a biopharmaceutical company whose primary business is to develop monoclonal antibody therapeutics for diseases that represent a significant burden to society and to patients and their families. The Company’s primary clinical focus is on respiratory diseases and cancer. The Company was incorporated on March 15, 2000 in California and reincorporated as a Delaware corporation in September 2001. All of the Company’s assets are located in California. | |
The Company has incurred significant losses and had an accumulated deficit of $160.4 million as of June 30, 2014. The Company has financed its operations primarily through the sale of equity securities, grants and the payments received under its agreements with Novartis Pharma AG (Novartis) and Sanofi Pasteur S.A. (Sanofi). The Company completed its initial public offering (IPO) in February 2013 and completed a secondary offering and sale of common stock in October 2013. To date, none of the Company’s product candidates have been approved for sale and therefore the Company has not generated any revenue from product sales. Management expects operating losses to continue for the foreseeable future. As a result, the Company will continue to require additional capital through equity offerings, debt financing and/or payments under new or existing licensing or collaboration agreements. If sufficient funds on acceptable terms are not available when needed, the Company could be required to significantly reduce its operating expenses and delay, reduce the scope of, or eliminate one or more of its development programs. | |
Summary_of_Significant_Account
Summary of Significant Accounting Policies | 6 Months Ended | |||||
Jun. 30, 2014 | ||||||
Summary of Significant Accounting Policies | ' | |||||
Summary of Significant Accounting Policies | ' | |||||
2. Summary of Significant Accounting Policies | ||||||
Basis of Presentation | ||||||
The accompanying interim unaudited condensed consolidated financial statements have been prepared in accordance with accounting principles generally accepted in the United States of America (“U.S. GAAP”) for interim financial information and on a basis consistent with the annual consolidated financial statements, and in the opinion of management, reflect all adjustments, which include only normal recurring adjustments, necessary for a fair statement of the periods presented. The December 31, 2013 Condensed Consolidated Balance Sheet was derived from the audited financial statements but does not include all disclosures required by GAAP. These interim financial results are not necessarily indicative of the results to be expected for the year ending December 31, 2014, or for any other future annual or interim period. The accompanying unaudited condensed consolidated financial statements should be read in conjunction with the audited consolidated financial statements and the related notes thereto included in the Company’s Annual Report on Form 10-K for the year ended December 31, 2013. | ||||||
Use of Estimates | ||||||
The preparation of financial statements in conformity with GAAP requires management to make estimates and assumptions that affect the amounts and disclosures reported in the financial statements and accompanying notes. Actual results could differ materially from those estimates. The Company believes judgment is involved in determining the stock-based compensation and accruals. The Company evaluates estimates and assumptions as facts and circumstances dictate. As future events and their effects cannot be determined with precision, actual results could differ from these estimates and assumptions, and those differences could be material to the consolidated financial statements. | ||||||
Concentration of Credit Risk | ||||||
Cash, cash equivalents, and marketable securities consist of financial instruments that potentially subject the Company to a concentration of credit risk in the event of a default by the related financial institution holding the securities, to the extent of the value recorded in the balance sheet. The Company invests cash that is not required for immediate operating needs primarily in highly liquid instruments with lower credit risk. The Company has established guidelines relating to the quality, diversification, and maturities of securities to enable the Company to manage its credit risk. | ||||||
Cash, Cash Equivalents, and Marketable Securities | ||||||
The Company considers all highly liquid investments with an original maturity of 90 days or less at the time of purchase to be cash equivalents. Investments in securities with remaining maturities of less than one year, or where our intent is to use the investments to fund current operations or to make them available for current operations, are classified as short-term and available for sale. Investments in securities with remaining maturities greater than one year are classified as noncurrent and available for sale (see Note 3). Securities available for sale are carried at estimated fair value, with unrealized gains and losses reported as part of accumulated other comprehensive income (loss), a separate component of stockholders’ equity. The Company has estimated the fair value amounts by using available market information. The cost of available-for-sale securities sold is based on the specific-identification method. | ||||||
Research and Development Expenses | ||||||
Development costs incurred in the research and development of new products are expensed as incurred, including expenses that may or may not be reimbursed under research and development collaboration agreements. Research and development costs include, but are not limited to, salaries, benefits, stock-based compensation, laboratory supplies, allocated overhead, fees for professional service providers and costs associated with product development efforts, including preclinical studies and clinical trials. Research and development expenses under collaborative agreements approximate or exceed the revenue recognized under such agreements. | ||||||
The Company estimates preclinical study and clinical trial expenses based on the services performed, pursuant to contracts with research institutions and clinical research organizations that conduct and manage preclinical studies and clinical trials on its behalf. In accruing service fees, the Company estimates the time period over which services will be performed and the level of effort to be expended in each period. 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. Payments made to third parties under these arrangements in advance of the receipt of the related services are recorded as prepaid expenses until the services are rendered. | ||||||
Stock-Based Compensation Expense | ||||||
The Company measures employee and director stock-based compensation expense for stock awards at the grant date and employee stock purchase plan, or ESPP, based on the fair value-based measurement of the award, and the expense is recorded over the related service period, generally the vesting period, net of estimated forfeitures. The Company calculates the fair value-based measurement of stock options and ESPP using the Black-Scholes valuation model and the single-option method and recognizes expense using the straight-line attribution approach. | ||||||
The Company accounts for equity instruments issued to nonemployees based on their fair values on the measurement dates using the Black-Scholes option-pricing model. The fair values of the options granted to nonemployees are remeasured as they vest. As a result, the noncash charge to operations for nonemployee options with vesting is affected each reporting period by changes in the fair value of the Company’s common stock. | ||||||
Comprehensive Loss | ||||||
Comprehensive loss represents net loss adjusted for the change during the periods presented in unrealized gains and losses on available-for-sale securities less reclassification adjustments for realized gains or losses included in net loss. The unrealized gains or losses are reported on the Consolidated Statements of Comprehensive Loss. | ||||||
Net Loss Per Common Share | ||||||
Basic net loss per common share is calculated by dividing the net loss by the weighted-average number of common shares outstanding during the period, without consideration of common stock equivalents. Diluted net loss per common share is computed by dividing the net loss by the weighted-average number of common shares and common share equivalents outstanding for the period. Common stock equivalents are only included in the calculation of diluted net loss per common share when their effect is dilutive. | ||||||
The Company’s potential dilutive securities which include unvested restricted stock, stock options, and warrants have been excluded from the computation of diluted net loss per share as the effect would be to reduce the net loss per share and be antidilutive. Therefore, the denominator used to calculate both basic and diluted net loss per common share is the same in all periods presented. | ||||||
The following shares of outstanding potentially dilutive securities have been excluded from the computations of diluted net loss per common share as the effect of including such securities would be antidilutive: | ||||||
As of June 30, | ||||||
2014 | 2013 | |||||
Warrants to purchase common stock | 88,545 | 88,545 | ||||
Options to purchase common stock | 2,651,522 | 1,720,637 | ||||
2,740,067 | 1,809,182 | |||||
Investments
Investments | 6 Months Ended | |||||||||||||
Jun. 30, 2014 | ||||||||||||||
Investments | ' | |||||||||||||
Investments | ' | |||||||||||||
3. Investments | ||||||||||||||
At June 30, 2014, the amortized cost and fair value of investments, with gross unrealized gains and losses, were as follows: | ||||||||||||||
(in thousands) | Amortized | Gross | Gross | Fair Value | ||||||||||
Cost | Unrealized | Unrealized | ||||||||||||
Gains | Losses | |||||||||||||
Money market funds | $ | 8,840 | $ | — | $ | — | $ | 8,840 | ||||||
Federal agency securities | 15,099 | (5 | ) | — | 15,094 | |||||||||
Commercial paper | 10,244 | — | 5 | 10,249 | ||||||||||
Corporate debt securities | 24,391 | — | — | 24,391 | ||||||||||
Total investments | $ | 58,574 | $ | (5 | ) | $ | 5 | $ | 58,574 | |||||
Reported as: | ||||||||||||||
Cash and cash equivalents | $ | 8,443 | ||||||||||||
Marketable securities, current | 48,981 | |||||||||||||
Marketable securities, non-current | 752 | |||||||||||||
Restricted cash | 398 | |||||||||||||
Total investments | $ | 58,574 | ||||||||||||
At December 31, 2013, the amortized cost and fair value of investments, with gross unrealized gains, were as follows: | ||||||||||||||
(in thousands) | Amortized | Gross | Gross | Fair Value | ||||||||||
Cost | Unrealized | Unrealized | ||||||||||||
Gains | Losses | |||||||||||||
Money market funds | $ | 53,511 | $ | — | $ | — | $ | 53,511 | ||||||
Federal agency securities | 12,301 | — | — | 12,301 | ||||||||||
Commercial paper | 8,246 | 3 | — | 8,249 | ||||||||||
Corporate debt securities | 1,961 | — | — | 1,961 | ||||||||||
Total investments | $ | 76,019 | $ | 3 | $ | — | $ | 76,022 | ||||||
Reported as: | ||||||||||||||
Cash and cash equivalents | $ | 53,306 | ||||||||||||
Marketable securities | 22,511 | |||||||||||||
Restricted cash | 205 | |||||||||||||
Total investments | $ | 76,022 | ||||||||||||
There were no realized gains or losses from the sale of marketable securities for the three and six months ended June 30, 2014 and 2013. | ||||||||||||||
Fair_Value_of_Financial_Instru
Fair Value of Financial Instruments | 6 Months Ended | |||||||||||||
Jun. 30, 2014 | ||||||||||||||
Fair Value of Financial Instruments | ' | |||||||||||||
Fair Value of Financial Instruments | ' | |||||||||||||
4. Fair Value of Financial Instruments | ||||||||||||||
Cash, accounts payable and accrued liabilities are carried at cost, which approximates fair value given their short-term nature. Marketable securities and cash equivalents are carried at fair value. | ||||||||||||||
The fair value of financial instruments reflects the amounts that would be received upon the sale of an asset or paid to transfer a liability in an orderly transaction between market participants at the measurement date (exit price). The fair value hierarchy is based on three levels of inputs that may be used to measure fair value, of which the first two are considered observable, and the third is considered unobservable, as follows: | ||||||||||||||
Level 1 — Quoted prices in active markets for identical assets or liabilities. | ||||||||||||||
Level 2 — Inputs other than those included in Level 1 that are directly or indirectly observable, such as quoted prices for similar assets or liabilities in active markets; quoted prices for identical or similar assets or liabilities in markets that are not active; or other inputs that are observable or can be corroborated by observable market data for substantially the full term of the assets or liabilities. | ||||||||||||||
Level 3 — Unobservable inputs that are supported by little or no market activity and that are significant to the fair value of the assets or liabilities. | ||||||||||||||
The Company measures the fair value of financial assets and liabilities using the highest level of inputs that are reasonably available as of the measurement date. The following tables summarize the fair value of financial assets and liabilities (investments) that are measured at fair value and the classification by level of input within the fair value hierarchy: | ||||||||||||||
Fair Value Measurements as of | ||||||||||||||
June 30, 2014 | ||||||||||||||
(in thousands) | Level 1 | Level 2 | Level 3 | Total | ||||||||||
Investments: | ||||||||||||||
Money market funds | $ | 8,840 | $ | — | $ | — | $ | 8,840 | ||||||
Federal agency securities | — | 15,094 | — | 15,094 | ||||||||||
Commercial paper | — | 10,249 | — | 10,249 | ||||||||||
Corporate debt securities | — | 24,391 | — | 24,391 | ||||||||||
Total investments | $ | 8,840 | $ | 49,734 | $ | — | $ | 58,574 | ||||||
Fair Value Measurements as of | ||||||||||||||
December 31, 2013 | ||||||||||||||
(in thousands) | Level 1 | Level 2 | Level 3 | Total | ||||||||||
Investments: | ||||||||||||||
Money market funds | $ | 53,511 | $ | — | $ | — | $ | 53,511 | ||||||
Federal agency securities | — | 12,301 | — | 12,301 | ||||||||||
Commercial paper | — | 8,249 | — | 8,249 | ||||||||||
Corporate debt securities | — | 1,961 | — | 1,961 | ||||||||||
Total investments | $ | 53,511 | $ | 22,511 | $ | — | $ | 76,022 | ||||||
The Company’s Level 2 investments include U.S. government-backed securities that are valued based upon observable inputs that may include benchmark yields, reported trades, broker/dealer quotes, issuer spreads, two-sided markets, benchmark securities, bids, offers and reference data including market research publications. The average remaining maturity of the Company’s Level 2 investments as of June 30, 2014 is less than ten months and all of these investments are rated A3/A-/A- or P1/A1/F1, or higher by Moody’s, S&P and Fitch. | ||||||||||||||
The estimated fair value of the notes payable as of June 30, 2014, as measured using Level 3 inputs, approximates the carrying amount as presented on the condensed consolidated balance sheet. | ||||||||||||||
Notes_Payable
Notes Payable | 6 Months Ended | ||||
Jun. 30, 2014 | |||||
Notes Payable | ' | ||||
Notes Payable | ' | ||||
5. Notes Payable | |||||
Loan and Security Agreement | |||||
In September 2012, the Company entered into the Agreement with MidCap Financial, providing for the borrowing of up to $15 million, of which $10 million was required to be drawn. The remaining $5 million was available to be drawn at the option of the Company. The Agreement provides for the loan to be issued in three tranches: the first tranche of $5 million was issued in September 2012; the second tranche of $5 million was issued in December 2012; and, prior to the amendment described below, the final tranche could have been drawn at the option of the Company no later than June 2013. The loan has a monthly variable interest rate, reset each month, if applicable, as determined by adding to 600 basis points the greater of: (a) one month LIBOR or (b) 3% (the LIBOR floor). Interest on amounts outstanding are payable monthly in arrears. There is an interest only period to December 31, 2013 followed by straight-line principal payments over thirty-six months until December 31, 2016. At the time of final payment, the Company must pay an exit fee of 3% of the drawn amount. Pursuant to the Agreement, the Company provided a first priority security interest in all existing and after-acquired assets, excluding intellectual property. In addition, the terms of the Agreement provided MidCap Financial a warrant to purchase shares of the Company’s Series E convertible preferred stock (Series E Preferred) equal to 4% of the amount drawn down under the facility divided by the Series E Preferred exercise price of $12.11 per share. The warrant expired upon the completion of the Company’s IPO. | |||||
The Company has the right to prepay all or a portion of the borrowed amounts under the Agreement; however, if the Company exercises this option, the Company must pay a prepayment fee determined by multiplying the outstanding loan amount by 5% if the prepayment occurs on or before December 31, 2014, 2% if the prepayment occurs in 2015 and 1% if the prepayment occurs in the final year. In the event of default, upon which all amounts borrowed become immediately due and payable, the Company will be subject to the prepayment fee. An event of default includes, but is not limited to, an occurrence such as a payment default, a material adverse change, insolvency, or a change of control. | |||||
In June 2013, the Company entered into the Amendment to extend the draw down date for the final tranche of $5.0 million from June 2013 to May 2014. In addition, the final tranche was changed from an optional draw down to a required draw down. In connection with the Amendment, the Company issued a warrant to purchase up to 49,548 shares of the Company’s common stock with an exercise price of $12.11 per share. The warrant expires on the tenth anniversary of its issuance date. The warrants issued to Midcap Financial had an initial fair value of $130,000, which represent financing fees, and are included in other assets in the accompanying consolidated balance sheet and are being amortized as non-cash interest expense over the remaining term of the Agreement using the effective interest method. The Company estimated the fair values of these warrants using the Black-Scholes option-pricing model, based on the inputs for the estimated fair value of the underlying common stock at the valuation measurement date, the contractual term of the warrant, risk-free interest rates, expected dividend rates and expected volatility of the price of the underlying common stock. Pursuant to this Amendment, the Company drew down the final tranche of $5.0 million in May 2014. | |||||
Future payments as of June 30, 2014 under the Agreement, assuming no adjustments to the variable rate of interest of 9% as of June 30, 2014, are as follows: | |||||
(in thousands) | |||||
Remainder of 2014 | $ | 3,154 | |||
2015 | 5,946 | ||||
2016 | 5,910 | ||||
Total minimum payments | 15,010 | ||||
Less amount representing interest | (1,632 | ) | |||
Notes payable, gross | 13,378 | ||||
Discount on notes payable | (82 | ) | |||
Accretion of the final exit fee payment | 127 | ||||
Carrying value of notes payable | $ | 13,423 | |||
Sanofi
Sanofi | 6 Months Ended |
Jun. 30, 2014 | |
Sanofi | ' |
Sanofi | ' |
6. Sanofi | |
In January 2010, the Company and Sanofi entered into an agreement for the development and commercialization of KB001, the precursor to KB001-A, an investigational new biologic for the treatment and prevention of Pseudomonas aeruginosa (Pa) infections (the Sanofi agreement). Under the terms of the Sanofi agreement, the Company received an initial upfront non-refundable payment of $35 million and received an additional non-refundable payment of $5 million that represented a second installment of the upfront fees due to the Company under the agreement upon completion of a sublicense negotiation with a third party in August 2011. Under the original terms, the Company may also have received development, regulatory and commercial contingent payments for a potential further $250 million, as well as royalties on eventual product sales, if any. These contingent payments would not meet the definition of milestones since they were based solely on Sanofi’s performance and therefore, the milestone method was applied to those payments, to the extent they were earned. Sanofi was solely responsible for conducting, at its cost, the research, development, manufacture, and commercialization of the licensed products for the diagnosis, treatment and/or prevention of all human diseases and conditions caused by Pa, except that the Company retained responsibility, at the Company’s cost, for developing and promoting the products for the diagnosis, treatment and/or prevention of Pa in patients with cystic fibrosis (CF) or bronchiectasis. The Sanofi agreement also gave Sanofi an option to obtain rights to participate in the development and promotion of KB001-A and other licensed products for the diagnosis, treatment and/or prevention of Pa in patients with CF or bronchiectasis, either outside of the U.S. or worldwide, at any time up to 90 days after the delivery by the Company to Sanofi of the final clinical study report from the Company’s Phase 2 clinical trial of KB001-A in Pa-infected patients with CF. Under the terms of the Sanofi agreement, the Company received specified research and development funding for services performed in connection with KB001-A research and development efforts. Reimbursements received by the Company for these services were recorded as contract revenue when earned as the related services were provided. | |
In July 2014, the Company and Sanofi executed an agreement (the Termination Agreement) under which the Sanofi agreement was terminated. As a result of the Termination Agreement, KaloBios regains full global rights to license, develop, manufacture and commercialize KB001-A in all indications, as well as a license to the KB001-A manufacturing process developed by Sanofi. In consideration for entering into the Termination Agreement, Sanofi will be entitled to low single digit royalties on net sales of KB001-A if approved, subject to a $40 million cap on the aggregate royalties to be paid. In addition, Sanofi will be entitled to receive up to 10% of certain sub-license payments or other milestone payments received in the event KaloBios successfully re-partners KB001-A, subject to a separate $40 million cap on the aggregate amount of sub-license payments to be shared with Sanofi. | |
Commitments_and_Contingencies
Commitments and Contingencies | 6 Months Ended |
Jun. 30, 2014 | |
Commitments and Contingencies | ' |
Commitments and Contingencies | ' |
7. Commitments and Contingencies | |
Contractual Obligations and Commitments | |
On May 21, 2013, the Company entered into an agreement with a third party for the manufacturing of KB003 clinical supply for future clinical trials. Despite the termination of the KB003 development program in severe asthma during the first quarter of 2014, we are continuing to evaluate other potential indications for KB003. Under that agreement the third party will perform a range of related services, including process development, optimization, validation, formulation development, regulatory assistance, stability testing and related activities. The agreement will remain in effect until services are completed or until either party terminates in accordance with the agreement. Supplies of material shall be according to FDA’s current Good Manufacturing Practice (cGMP) when required. As of June 30, 2014, there was a remaining commitment for services of approximately $1.6 million with the third party which is currently expected to be incurred through 2015. | |
Aside from the updated contractual commitment disclosed above, as of June 30, 2014, there were no significant and material changes to our contractual obligations from those set forth in our Annual Report on Form 10-K (File No. 001-35798), filed with the Securities and Exchange Commission (SEC) on March 13, 2014. | |
Guarantees and Indemnifications | |
The Company, as permitted under Delaware law and in accordance with its bylaws, has agreed to indemnify its officers and directors for certain events or occurrences, subject to certain limits, while the officer or director is or was serving at the Company’s request in such capacity. The term of the indemnification period is equal to the officer’s or director’s lifetime. The maximum amount of potential future indemnification is unlimited; however, the Company currently holds director and officer liability insurance. This insurance limits the Company’s exposure and may enable it to recover a portion of any future amounts paid. | |
The Company has certain agreements with service providers with which it does business that contain indemnification provisions pursuant to which the Company typically agrees to indemnify the party against certain types of third-party claims. The Company accrues for known indemnification issues when a loss is probable and can be reasonably estimated. The Company would also accrue for estimated incurred but unidentified indemnification issues based on historical activity. As the Company has not incurred any indemnification losses to date, there were no accruals for or expenses related to indemnification issues for any period presented. | |
Warrants_to_Purchase_Common_St
Warrants to Purchase Common Stock | 6 Months Ended |
Jun. 30, 2014 | |
Warrants to Purchase Common Stock | ' |
Warrants to Purchase Common Stock | ' |
8. Warrants to Purchase Common Stock | |
On June 19, 2013, in connection with the Amendment to its debt agreement with MidCap Financial, the Company issued a warrant to purchase up to 49,548 shares of the Company’s common stock with an exercise price of $12.11 per share. The warrant expires in June 2023. The Company recorded the initial value of the warrants in equity and other assets in the accompanying consolidated balance sheet, with the deferred other asset to be amortized over the remaining term of the debt using the effective interest method. | |
In addition, the Company has outstanding warrants to purchase an aggregate of 38,997 shares of common stock at $5.13 per share which will expire on October 31, 2015. | |
Stockholders_Equity
Stockholders' Equity | 6 Months Ended | |||||||||||||
Jun. 30, 2014 | ||||||||||||||
Stockholders' Equity | ' | |||||||||||||
Stockholders' Equity | ' | |||||||||||||
9. Stockholders’ Equity | ||||||||||||||
2012 Equity Incentive Plan | ||||||||||||||
As of June 30, 2014, under the 2012 Equity Incentive Plan, the Company may grant shares, stock units, stock appreciation rights, performance cash awards and/or options to employees, directors, consultants, and other service providers. For options, the per share exercise price may not be less than the fair market value of a Company common share on the date of grant. Awards generally vest over four years and expire 10 years from the date of grant. Options generally become exercisable as they vest following the date of grant. | ||||||||||||||
A summary of stock option activity for the six months ended June 30, 2014 under all of the Company’s options plans is as follows: | ||||||||||||||
Options | Weighted | |||||||||||||
Average | ||||||||||||||
Exercise | ||||||||||||||
Price | ||||||||||||||
Outstanding at December 31, 2013 | 1,820,784 | $ | 4.46 | |||||||||||
Granted | 876,500 | 5.37 | ||||||||||||
Exercised | (50,304 | ) | 1.18 | |||||||||||
Cancelled | (98,666 | ) | 6.35 | |||||||||||
Outstanding at March 31, 2014 | 2,548,314 | $ | 4.77 | |||||||||||
Granted | 193,000 | 2.08 | ||||||||||||
Exercised | — | — | ||||||||||||
Cancelled | (89,792 | ) | 5.93 | |||||||||||
Outstanding at June 30, 2014 | 2,651,522 | $ | 4.53 | |||||||||||
The weighted average fair value of options granted during the three and six months ended June 30, 2014 were $1.39 per share and $3.08 per share, respectively. | ||||||||||||||
2012 Employee Stock Purchase Plan | ||||||||||||||
The Employee Stock Purchase Plan, or ESPP, provides eligible employees with the opportunity to acquire an ownership interest in the Company through periodic payroll deductions, based on a six-month look-back period, at a price equal to the lesser of 85% of the fair market value of the ordinary shares at either the beginning or ending of the relevant offering period. The ESPP is structured as a qualified employee stock purchase plan under Section 423 of the Internal Revenue Code of 1986. However, the ESPP is not intended to be a qualified pension, profit sharing or stock bonus plan under Section 401(a) of the Internal Revenue Code of 1986 and is not subject to the provisions of the Employee Retirement Income Security Act of 1974. The ESPP will terminate on January 15, 2033 unless sooner terminated. There were 168,469 shares initially authorized for issuance under the plan, and the first offering period commenced June 1, 2014. | ||||||||||||||
Stock-Based Compensation | ||||||||||||||
The Company recorded stock-based compensation expense in the condensed consolidated statements of comprehensive loss as follows: | ||||||||||||||
Three Months | Six Months | |||||||||||||
Ended June 30, | Ended June 30, | |||||||||||||
(In thousands) | 2014 | 2013 | 2014 | 2013 | ||||||||||
General and administrative | $ | 247 | $ | 174 | $ | 473 | $ | 259 | ||||||
Research and development | 280 | 199 | 545 | 295 | ||||||||||
$ | 527 | $ | 373 | $ | 1,018 | $ | 554 | |||||||
At June 30, 2014, the Company had $4.4 million of total unrecognized compensation expense, net of estimated forfeitures, related to outstanding stock options that will be recognized over a weighted-average period of 2.8 years. | ||||||||||||||
Summary_of_Significant_Account1
Summary of Significant Accounting Policies (Policies) | 6 Months Ended | |||||
Jun. 30, 2014 | ||||||
Summary of Significant Accounting Policies | ' | |||||
Basis of Presentation | ' | |||||
Basis of Presentation | ||||||
The accompanying interim unaudited condensed consolidated financial statements have been prepared in accordance with accounting principles generally accepted in the United States of America (“U.S. GAAP”) for interim financial information and on a basis consistent with the annual consolidated financial statements, and in the opinion of management, reflect all adjustments, which include only normal recurring adjustments, necessary for a fair statement of the periods presented. The December 31, 2013 Condensed Consolidated Balance Sheet was derived from the audited financial statements but does not include all disclosures required by GAAP. These interim financial results are not necessarily indicative of the results to be expected for the year ending December 31, 2014, or for any other future annual or interim period. The accompanying unaudited condensed consolidated financial statements should be read in conjunction with the audited consolidated financial statements and the related notes thereto included in the Company’s Annual Report on Form 10-K for the year ended December 31, 2013. | ||||||
Use of Estimates | ' | |||||
Use of Estimates | ||||||
The preparation of financial statements in conformity with GAAP requires management to make estimates and assumptions that affect the amounts and disclosures reported in the financial statements and accompanying notes. Actual results could differ materially from those estimates. The Company believes judgment is involved in determining the stock-based compensation and accruals. The Company evaluates estimates and assumptions as facts and circumstances dictate. As future events and their effects cannot be determined with precision, actual results could differ from these estimates and assumptions, and those differences could be material to the consolidated financial statements. | ||||||
Concentration of Credit Risk | ' | |||||
Concentration of Credit Risk | ||||||
Cash, cash equivalents, and marketable securities consist of financial instruments that potentially subject the Company to a concentration of credit risk in the event of a default by the related financial institution holding the securities, to the extent of the value recorded in the balance sheet. The Company invests cash that is not required for immediate operating needs primarily in highly liquid instruments with lower credit risk. The Company has established guidelines relating to the quality, diversification, and maturities of securities to enable the Company to manage its credit risk. | ||||||
Cash, Cash Equivalents, and Marketable Securities | ' | |||||
Cash, Cash Equivalents, and Marketable Securities | ||||||
The Company considers all highly liquid investments with an original maturity of 90 days or less at the time of purchase to be cash equivalents. Investments in securities with remaining maturities of less than one year, or where our intent is to use the investments to fund current operations or to make them available for current operations, are classified as short-term and available for sale. Investments in securities with remaining maturities greater than one year are classified as noncurrent and available for sale (see Note 3). Securities available for sale are carried at estimated fair value, with unrealized gains and losses reported as part of accumulated other comprehensive income (loss), a separate component of stockholders’ equity. The Company has estimated the fair value amounts by using available market information. The cost of available-for-sale securities sold is based on the specific-identification method. | ||||||
Research and Development Expenses | ' | |||||
Research and Development Expenses | ||||||
Development costs incurred in the research and development of new products are expensed as incurred, including expenses that may or may not be reimbursed under research and development collaboration agreements. Research and development costs include, but are not limited to, salaries, benefits, stock-based compensation, laboratory supplies, allocated overhead, fees for professional service providers and costs associated with product development efforts, including preclinical studies and clinical trials. Research and development expenses under collaborative agreements approximate or exceed the revenue recognized under such agreements. | ||||||
The Company estimates preclinical study and clinical trial expenses based on the services performed, pursuant to contracts with research institutions and clinical research organizations that conduct and manage preclinical studies and clinical trials on its behalf. In accruing service fees, the Company estimates the time period over which services will be performed and the level of effort to be expended in each period. 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. Payments made to third parties under these arrangements in advance of the receipt of the related services are recorded as prepaid expenses until the services are rendered. | ||||||
Stock-Based Compensation Expense | ' | |||||
Stock-Based Compensation Expense | ||||||
The Company measures employee and director stock-based compensation expense for stock awards at the grant date and employee stock purchase plan, or ESPP, based on the fair value-based measurement of the award, and the expense is recorded over the related service period, generally the vesting period, net of estimated forfeitures. The Company calculates the fair value-based measurement of stock options and ESPP using the Black-Scholes valuation model and the single-option method and recognizes expense using the straight-line attribution approach. | ||||||
The Company accounts for equity instruments issued to nonemployees based on their fair values on the measurement dates using the Black-Scholes option-pricing model. The fair values of the options granted to nonemployees are remeasured as they vest. As a result, the noncash charge to operations for nonemployee options with vesting is affected each reporting period by changes in the fair value of the Company’s common stock. | ||||||
Comprehensive Loss | ' | |||||
Comprehensive Loss | ||||||
Comprehensive loss represents net loss adjusted for the change during the periods presented in unrealized gains and losses on available-for-sale securities less reclassification adjustments for realized gains or losses included in net loss. The unrealized gains or losses are reported on the Consolidated Statements of Comprehensive Loss. | ||||||
Net Loss Per Common Share | ' | |||||
Net Loss Per Common Share | ||||||
Basic net loss per common share is calculated by dividing the net loss by the weighted-average number of common shares outstanding during the period, without consideration of common stock equivalents. Diluted net loss per common share is computed by dividing the net loss by the weighted-average number of common shares and common share equivalents outstanding for the period. Common stock equivalents are only included in the calculation of diluted net loss per common share when their effect is dilutive. | ||||||
The Company’s potential dilutive securities which include unvested restricted stock, stock options, and warrants have been excluded from the computation of diluted net loss per share as the effect would be to reduce the net loss per share and be antidilutive. Therefore, the denominator used to calculate both basic and diluted net loss per common share is the same in all periods presented. | ||||||
The following shares of outstanding potentially dilutive securities have been excluded from the computations of diluted net loss per common share as the effect of including such securities would be antidilutive: | ||||||
As of June 30, | ||||||
2014 | 2013 | |||||
Warrants to purchase common stock | 88,545 | 88,545 | ||||
Options to purchase common stock | 2,651,522 | 1,720,637 | ||||
2,740,067 | 1,809,182 | |||||
Summary_of_Significant_Account2
Summary of Significant Accounting Policies (Tables) | 6 Months Ended | |||||
Jun. 30, 2014 | ||||||
Summary of Significant Accounting Policies | ' | |||||
Schedule of antidilutive securities excluded from computations of diluted net loss per common share | ' | |||||
As of June 30, | ||||||
2014 | 2013 | |||||
Warrants to purchase common stock | 88,545 | 88,545 | ||||
Options to purchase common stock | 2,651,522 | 1,720,637 | ||||
2,740,067 | 1,809,182 | |||||
Investments_Tables
Investments (Tables) | 6 Months Ended | |||||||||||||
Jun. 30, 2014 | ||||||||||||||
Investments | ' | |||||||||||||
Schedule of amortized cost and fair value of investments, with gross unrealized gains and losses | ' | |||||||||||||
At June 30, 2014, the amortized cost and fair value of investments, with gross unrealized gains and losses, were as follows: | ||||||||||||||
(in thousands) | Amortized | Gross | Gross | Fair Value | ||||||||||
Cost | Unrealized | Unrealized | ||||||||||||
Gains | Losses | |||||||||||||
Money market funds | $ | 8,840 | $ | — | $ | — | $ | 8,840 | ||||||
Federal agency securities | 15,099 | (5 | ) | — | 15,094 | |||||||||
Commercial paper | 10,244 | — | 5 | 10,249 | ||||||||||
Corporate debt securities | 24,391 | — | — | 24,391 | ||||||||||
Total investments | $ | 58,574 | $ | (5 | ) | $ | 5 | $ | 58,574 | |||||
Reported as: | ||||||||||||||
Cash and cash equivalents | $ | 8,443 | ||||||||||||
Marketable securities, current | 48,981 | |||||||||||||
Marketable securities, non-current | 752 | |||||||||||||
Restricted cash | 398 | |||||||||||||
Total investments | $ | 58,574 | ||||||||||||
At December 31, 2013, the amortized cost and fair value of investments, with gross unrealized gains, were as follows: | ||||||||||||||
(in thousands) | Amortized | Gross | Gross | Fair Value | ||||||||||
Cost | Unrealized | Unrealized | ||||||||||||
Gains | Losses | |||||||||||||
Money market funds | $ | 53,511 | $ | — | $ | — | $ | 53,511 | ||||||
Federal agency securities | 12,301 | — | — | 12,301 | ||||||||||
Commercial paper | 8,246 | 3 | — | 8,249 | ||||||||||
Corporate debt securities | 1,961 | — | — | 1,961 | ||||||||||
Total investments | $ | 76,019 | $ | 3 | $ | — | $ | 76,022 | ||||||
Reported as: | ||||||||||||||
Cash and cash equivalents | $ | 53,306 | ||||||||||||
Marketable securities | 22,511 | |||||||||||||
Restricted cash | 205 | |||||||||||||
Total investments | $ | 76,022 | ||||||||||||
Fair_Value_of_Financial_Instru1
Fair Value of Financial Instruments (Tables) | 6 Months Ended | |||||||||||||
Jun. 30, 2014 | ||||||||||||||
Fair Value of Financial Instruments | ' | |||||||||||||
Schedule of fair value of financial assets and liabilities measured at fair value and classification by level of input | ' | |||||||||||||
Fair Value Measurements as of | ||||||||||||||
June 30, 2014 | ||||||||||||||
(in thousands) | Level 1 | Level 2 | Level 3 | Total | ||||||||||
Investments: | ||||||||||||||
Money market funds | $ | 8,840 | $ | — | $ | — | $ | 8,840 | ||||||
Federal agency securities | — | 15,094 | — | 15,094 | ||||||||||
Commercial paper | — | 10,249 | — | 10,249 | ||||||||||
Corporate debt securities | — | 24,391 | — | 24,391 | ||||||||||
Total investments | $ | 8,840 | $ | 49,734 | $ | — | $ | 58,574 | ||||||
Fair Value Measurements as of | ||||||||||||||
December 31, 2013 | ||||||||||||||
(in thousands) | Level 1 | Level 2 | Level 3 | Total | ||||||||||
Investments: | ||||||||||||||
Money market funds | $ | 53,511 | $ | — | $ | — | $ | 53,511 | ||||||
Federal agency securities | — | 12,301 | — | 12,301 | ||||||||||
Commercial paper | — | 8,249 | — | 8,249 | ||||||||||
Corporate debt securities | — | 1,961 | — | 1,961 | ||||||||||
Total investments | $ | 53,511 | $ | 22,511 | $ | — | $ | 76,022 | ||||||
Notes_Payable_Tables
Notes Payable (Tables) | 6 Months Ended | ||||
Jun. 30, 2014 | |||||
Notes Payable | ' | ||||
Schedule of future payments under the agreement, assuming no adjustments to the variable rate of interest | ' | ||||
Future payments as of June 30, 2014 under the Agreement, assuming no adjustments to the variable rate of interest of 9% as of June 30, 2014, are as follows: | |||||
(in thousands) | |||||
Remainder of 2014 | $ | 3,154 | |||
2015 | 5,946 | ||||
2016 | 5,910 | ||||
Total minimum payments | 15,010 | ||||
Less amount representing interest | (1,632 | ) | |||
Notes payable, gross | 13,378 | ||||
Discount on notes payable | (82 | ) | |||
Accretion of the final exit fee payment | 127 | ||||
Carrying value of notes payable | $ | 13,423 | |||
Stockholders_Equity_Tables
Stockholders' Equity (Tables) | 6 Months Ended | |||||||||||||
Jun. 30, 2014 | ||||||||||||||
Stockholders' Equity | ' | |||||||||||||
Summary of stock option activity | ' | |||||||||||||
Options | Weighted | |||||||||||||
Average | ||||||||||||||
Exercise | ||||||||||||||
Price | ||||||||||||||
Outstanding at December 31, 2013 | 1,820,784 | $ | 4.46 | |||||||||||
Granted | 876,500 | 5.37 | ||||||||||||
Exercised | (50,304 | ) | 1.18 | |||||||||||
Cancelled | (98,666 | ) | 6.35 | |||||||||||
Outstanding at March 31, 2014 | 2,548,314 | $ | 4.77 | |||||||||||
Granted | 193,000 | 2.08 | ||||||||||||
Exercised | — | — | ||||||||||||
Cancelled | (89,792 | ) | 5.93 | |||||||||||
Outstanding at June 30, 2014 | 2,651,522 | $ | 4.53 | |||||||||||
Schedule of recorded stock-based compensation expense in the condensed consolidated statements of comprehensive loss | ' | |||||||||||||
Three Months | Six Months | |||||||||||||
Ended June 30, | Ended June 30, | |||||||||||||
(In thousands) | 2014 | 2013 | 2014 | 2013 | ||||||||||
General and administrative | $ | 247 | $ | 174 | $ | 473 | $ | 259 | ||||||
Research and development | 280 | 199 | 545 | 295 | ||||||||||
$ | 527 | $ | 373 | $ | 1,018 | $ | 554 | |||||||
Nature_of_Operations_Details
Nature of Operations (Details) (USD $) | Jun. 30, 2014 | Dec. 31, 2013 |
In Thousands, unless otherwise specified | ||
Nature of Operations | ' | ' |
Accumulated deficit | $160,437 | $140,215 |
Summary_of_Significant_Account3
Summary of Significant Accounting Policies (Details) | 6 Months Ended | |
Jun. 30, 2014 | Jun. 30, 2013 | |
Net loss per common share | ' | ' |
Antidilutive securities excluded from computations of diluted net loss per common share | 2,740,067 | 1,809,182 |
Warrants To Purchase Common Stock [Member] | ' | ' |
Net loss per common share | ' | ' |
Antidilutive securities excluded from computations of diluted net loss per common share | 88,545 | 88,545 |
Employee And Nonemployee Stock Options [Member] | ' | ' |
Net loss per common share | ' | ' |
Antidilutive securities excluded from computations of diluted net loss per common share | 2,651,522 | 1,720,637 |
Investments_Details
Investments (Details) (USD $) | 3 Months Ended | 6 Months Ended | |||
In Thousands, unless otherwise specified | Jun. 30, 2014 | Jun. 30, 2013 | Jun. 30, 2014 | Jun. 30, 2013 | Dec. 31, 2013 |
Investments | ' | ' | ' | ' | ' |
Amortized Cost | $58,574 | ' | $58,574 | ' | $76,019 |
Gross Unrealized Gains | -5 | ' | -5 | ' | 3 |
Gross Unrealized Losses | 5 | ' | 5 | ' | ' |
Fair Value | 58,574 | ' | 58,574 | ' | 76,022 |
Realized gains or losses recorded from the sale of marketable securities | 0 | 0 | 0 | 0 | ' |
Cash And Cash Equivalent [Member] | ' | ' | ' | ' | ' |
Investments | ' | ' | ' | ' | ' |
Fair Value | 8,443 | ' | 8,443 | ' | 53,306 |
Marketable Securities [Member] | ' | ' | ' | ' | ' |
Investments | ' | ' | ' | ' | ' |
Fair Value | ' | ' | ' | ' | 22,511 |
Marketable Securities Current [Member] | ' | ' | ' | ' | ' |
Investments | ' | ' | ' | ' | ' |
Fair Value | 48,981 | ' | 48,981 | ' | ' |
Marketable Securities Non Current [Member] | ' | ' | ' | ' | ' |
Investments | ' | ' | ' | ' | ' |
Fair Value | 752 | ' | 752 | ' | ' |
Restricted Cash [Member] | ' | ' | ' | ' | ' |
Investments | ' | ' | ' | ' | ' |
Fair Value | 398 | ' | 398 | ' | 205 |
Money Market Funds [Member] | ' | ' | ' | ' | ' |
Investments | ' | ' | ' | ' | ' |
Amortized Cost | 8,840 | ' | 8,840 | ' | 53,511 |
Fair Value | 8,840 | ' | 8,840 | ' | 53,511 |
U S Government Corporations And Agencies Securities [Member] | ' | ' | ' | ' | ' |
Investments | ' | ' | ' | ' | ' |
Amortized Cost | 15,099 | ' | 15,099 | ' | 12,301 |
Gross Unrealized Gains | -5 | ' | -5 | ' | ' |
Fair Value | 15,094 | ' | 15,094 | ' | 12,301 |
Commercial Paper [Member] | ' | ' | ' | ' | ' |
Investments | ' | ' | ' | ' | ' |
Amortized Cost | 10,244 | ' | 10,244 | ' | 8,246 |
Gross Unrealized Gains | ' | ' | ' | ' | 3 |
Gross Unrealized Losses | 5 | ' | 5 | ' | ' |
Fair Value | 10,249 | ' | 10,249 | ' | 8,249 |
Corporate Debt Securities [Member] | ' | ' | ' | ' | ' |
Investments | ' | ' | ' | ' | ' |
Amortized Cost | 24,391 | ' | 24,391 | ' | 1,961 |
Fair Value | $24,391 | ' | $24,391 | ' | $1,961 |
Fair_Value_of_Financial_Instru2
Fair Value of Financial Instruments (Details) (USD $) | Jun. 30, 2014 | Dec. 31, 2013 |
In Thousands, unless otherwise specified | ||
Fair Value of Financial Instruments | ' | ' |
Investments | $48,981 | $22,511 |
Fair Value Measurements Recurring [Member] | Fair Value Inputs Level1 [Member] | ' | ' |
Fair Value of Financial Instruments | ' | ' |
Investments | 8,840 | 53,511 |
Fair Value Measurements Recurring [Member] | Fair Value Inputs Level1 [Member] | Money Market Funds [Member] | ' | ' |
Fair Value of Financial Instruments | ' | ' |
Investments | 8,840 | 53,511 |
Fair Value Measurements Recurring [Member] | Fair Value Inputs Level2 [Member] | ' | ' |
Fair Value of Financial Instruments | ' | ' |
Investments | 49,734 | 22,511 |
Fair Value Measurements Recurring [Member] | Fair Value Inputs Level2 [Member] | U S Government Corporations And Agencies Securities [Member] | ' | ' |
Fair Value of Financial Instruments | ' | ' |
Investments | 15,094 | 12,301 |
Fair Value Measurements Recurring [Member] | Fair Value Inputs Level2 [Member] | Commercial Paper [Member] | ' | ' |
Fair Value of Financial Instruments | ' | ' |
Investments | 10,249 | 8,249 |
Fair Value Measurements Recurring [Member] | Fair Value Inputs Level2 [Member] | Corporate Debt Securities [Member] | ' | ' |
Fair Value of Financial Instruments | ' | ' |
Investments | 24,391 | 1,961 |
Fair Value Measurements Recurring [Member] | Estimate Of Fair Value Fair Value Disclosure [Member] | ' | ' |
Fair Value of Financial Instruments | ' | ' |
Investments | 58,574 | 76,022 |
Fair Value Measurements Recurring [Member] | Estimate Of Fair Value Fair Value Disclosure [Member] | Money Market Funds [Member] | ' | ' |
Fair Value of Financial Instruments | ' | ' |
Investments | 8,840 | 53,511 |
Fair Value Measurements Recurring [Member] | Estimate Of Fair Value Fair Value Disclosure [Member] | U S Government Corporations And Agencies Securities [Member] | ' | ' |
Fair Value of Financial Instruments | ' | ' |
Investments | 15,094 | 12,301 |
Fair Value Measurements Recurring [Member] | Estimate Of Fair Value Fair Value Disclosure [Member] | Commercial Paper [Member] | ' | ' |
Fair Value of Financial Instruments | ' | ' |
Investments | 10,249 | 8,249 |
Fair Value Measurements Recurring [Member] | Estimate Of Fair Value Fair Value Disclosure [Member] | Corporate Debt Securities [Member] | ' | ' |
Fair Value of Financial Instruments | ' | ' |
Investments | $24,391 | $1,961 |
Notes_Payable_Details
Notes Payable (Details) (USD $) | Jun. 30, 2014 | Sep. 30, 2012 | Jun. 30, 2014 | Jun. 19, 2013 | Sep. 30, 2012 | Sep. 30, 2012 | Jun. 30, 2014 | Sep. 30, 2012 | Jun. 30, 2014 | Sep. 30, 2012 | Jun. 30, 2014 | Sep. 30, 2012 | Sep. 30, 2012 | Sep. 30, 2012 | Sep. 30, 2012 | 31-May-14 | Jun. 30, 2013 | Sep. 30, 2012 |
Loan And Security Agreement [Member] | Loan And Security Agreement [Member] | Loan And Security Agreement [Member] | Loan And Security Agreement [Member] | Loan And Security Agreement [Member] | Loan And Security Agreement [Member] | Loan And Security Agreement [Member] | Loan And Security Agreement [Member] | Loan And Security Agreement [Member] | Loan And Security Agreement [Member] | Loan And Security Agreement [Member] | Loan And Security Agreement [Member] | Loan And Security Agreement [Member] | Loan And Security Agreement [Member] | Loan And Security Agreement [Member] | Loan And Security Agreement [Member] | Loan And Security Agreement [Member] | ||
tranche | London Interbank Offered Rate L I B O R [Member] | Debt Instrument Redemption Period One [Member] | Debt Instrument Redemption Period One [Member] | Debt Instrument Redemption Period Two [Member] | Debt Instrument Redemption Period Two [Member] | Debt Instrument Redemption Period Three [Member] | Debt Instrument Redemption Period Three [Member] | Minimum [Member] | First Tranche [Member] | First Tranche [Member] | Second Tranche [Member] | Third Tranche [Member] | Third Tranche [Member] | Third Tranche [Member] | ||||
Series E Preferred Stock [Member] | ||||||||||||||||||
Notes payable | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' |
Maximum amount of borrowing under the agreement | ' | $15,000,000 | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | $5,000,000 | ' | $5,000,000 | ' | ' | $5,000,000 |
Amount of borrowing required to be drawn | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | 10,000,000 | ' | ' | ' | ' | ' | ' |
Amount of remaining borrowing capacity | ' | 5,000,000 | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' |
Number of loan tranches | ' | 3 | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' |
Variable rate basis | ' | ' | ' | ' | 'one month LIBOR | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' |
Spread on variable rate (as a percent) | ' | ' | ' | ' | 6.00% | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' |
LIBOR floor rate | ' | ' | ' | ' | 3.00% | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' |
Straight-line principal payments period | ' | '36 months | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' |
Percentage of exit fee of drawn amount | ' | 3.00% | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' |
Warrants issued as a percentage of amount drawn under credit facility | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | 4.00% | ' | ' | ' | ' |
Exercise price of warrant (in dollars per share) | 5.13 | ' | ' | 12.11 | ' | ' | ' | ' | ' | ' | ' | ' | ' | 12.11 | ' | ' | 12.11 | ' |
Prepayment fee percentage | ' | ' | ' | ' | ' | ' | 5.00% | ' | 2.00% | ' | 1.00% | ' | ' | ' | ' | ' | ' | ' |
Prepayment period start date | ' | ' | ' | ' | ' | ' | ' | 1-Jan-14 | ' | 1-Jan-16 | ' | ' | ' | ' | ' | ' | ' | ' |
Prepayment period end date | ' | ' | ' | ' | ' | 31-Dec-14 | ' | 31-Dec-15 | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' |
Tranche draw down | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | 5,000,000 | 5,000,000 | ' |
Debt discount related to issuance of warrants | ' | ' | 82,000 | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' |
Issuance of warrant to purchase shares of common stock | 38,997 | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | 49,548 | ' |
Warrants initial fair value | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | $130,000 | ' |
Notes_Payable_Details_2
Notes Payable (Details 2) (USD $) | Jun. 30, 2014 |
In Thousands, unless otherwise specified | |
Debt obligations | ' |
Variable rate of interest (as a percent) | 9.00% |
Loan And Security Agreement [Member] | ' |
Debt obligations | ' |
Remainder of 2014 | 3,154 |
2015 | 5,946 |
2016 | 5,910 |
Total minimum payments | 15,010 |
Less amount representing interest | -1,632 |
Notes payable, gross | 13,378 |
Discount on notes payable | -82 |
Accretion of the final exit fee payment | 127 |
Carrying value of notes payable | 13,423 |
Sanofi_Details
Sanofi (Details) (Sanofi [Member], USD $) | 6 Months Ended | |
In Millions, unless otherwise specified | Jun. 30, 2014 | Jul. 31, 2014 |
Subsequent Event [Member] | ||
Research and Development Collaboration and License Agreements | ' | ' |
Initial upfront non-refundable payment | $35 | ' |
Additional non-refundable payment | 5 | ' |
Development, regulatory and commercial contingent payments | 250 | ' |
Maximum days to participate in development and promotion of products | '90 days | ' |
Maximum amount of royalties to be payable | ' | 40 |
Percentage of sub-license payments to be shared | ' | 10.00% |
Maximum amount of sub-license payments to be shared | ' | $40 |
Commitments_and_Contingencies_
Commitments and Contingencies (Details) (USD $) | 6 Months Ended |
In Millions, unless otherwise specified | Jun. 30, 2014 |
Commitments and Contingencies | ' |
Accruals or expenses related to indemnification issues | $0 |
Remaining commitment for services | $1.60 |
Warrants_to_Purchase_Common_St1
Warrants to Purchase Common Stock (Details) | Jun. 30, 2014 | Jun. 19, 2013 | Jun. 19, 2013 |
Loan And Security Agreement [Member] | Loan And Security Agreement [Member] | ||
Maximum [Member] | |||
Common stock warrant liabilities | ' | ' | ' |
Issuance of warrant to purchase shares of common stock | 38,997 | ' | 49,548 |
Exercise price of warrants issued (in dollars per share) | 5.13 | 12.11 | ' |
Stockholders_Equity_Details
Stockholders' Equity (Details) (USD $) | 3 Months Ended | 6 Months Ended | |
Jun. 30, 2014 | Mar. 31, 2014 | Jun. 30, 2014 | |
Options | ' | ' | ' |
Outstanding at the beginning of the period (in shares) | 2,548,314 | 1,820,784 | 1,820,784 |
Granted (in shares) | 193,000 | 876,500 | ' |
Exercised (in shares) | ' | -50,304 | ' |
Canceled (in shares) | -89,792 | -98,666 | ' |
Outstanding at the end of the period (in shares) | 2,651,522 | 2,548,314 | 2,651,522 |
Weighted-Average Exercise Price (Per Share) | ' | ' | ' |
Outstanding at the beginning of the period (in dollars per share) | $4.77 | $4.46 | $4.46 |
Granted (in dollars per share) | $2.08 | $5.37 | ' |
Exercised (in dollars per share) | ' | $1.18 | ' |
Canceled (in dollars per share) | $5.93 | $6.35 | ' |
Outstanding at the end of the period (in dollars per share) | $4.53 | $4.77 | $4.53 |
Weighted-average fair value of options granted during the period | $1.39 | ' | $3.08 |
Equity Incentive Plan Twenty Twelve [Member] | ' | ' | ' |
Stock-Based Compensation Plans | ' | ' | ' |
Vesting period | ' | ' | '4 years |
Vesting period expiration | ' | ' | '10 years |
Employee Stock Purchase Plan Twenty Twelve [Member] | ' | ' | ' |
Stock-Based Compensation Plans | ' | ' | ' |
Look-back period for payroll deductions to acquire ownership interest | ' | ' | '6 months |
Weighted-Average Exercise Price (Per Share) | ' | ' | ' |
Fair market value percentage of ordinary shares | 85.00% | ' | 85.00% |
Number of shares authorized to be issued under the plan, before 2001 Plan additions | 168,469 | ' | 168,469 |
Stockholders_Equity_Details_2
Stockholders' Equity (Details 2) (USD $) | 3 Months Ended | 6 Months Ended | ||
Jun. 30, 2014 | Jun. 30, 2013 | Jun. 30, 2014 | Jun. 30, 2013 | |
Stock-based compensation expense | ' | ' | ' | ' |
Stock-based compensation expense | $527,000 | $373,000 | $1,018,000 | $554,000 |
Unrecognized compensation expense | 4,400,000 | ' | 4,400,000 | ' |
Weighted-average period | ' | ' | '2 years 9 months 18 days | ' |
General And Administrative Expense [Member] | ' | ' | ' | ' |
Stock-based compensation expense | ' | ' | ' | ' |
Stock-based compensation expense | 247,000 | 174,000 | 473,000 | 259,000 |
Research And Development Expense [Member] | ' | ' | ' | ' |
Stock-based compensation expense | ' | ' | ' | ' |
Stock-based compensation expense | $280,000 | $199,000 | $545,000 | $295,000 |