Document and Entity Information
Document and Entity Information - USD ($) $ in Millions | 12 Months Ended | ||
Dec. 31, 2015 | Mar. 10, 2016 | Jun. 30, 2015 | |
Document And Entity Information [Abstract] | |||
Document Type | 10-K | ||
Amendment Flag | false | ||
Document Period End Date | Dec. 31, 2015 | ||
Document Fiscal Year Focus | 2,015 | ||
Document Fiscal Period Focus | FY | ||
Entity Registrant Name | Mast Therapeutics, Inc. | ||
Entity Central Index Key | 1,160,308 | ||
Current Fiscal Year End Date | --12-31 | ||
Entity Well-known Seasoned Issuer | No | ||
Entity Current Reporting Status | Yes | ||
Entity Voluntary Filers | No | ||
Entity Filer Category | Smaller Reporting Accelerated Filer | ||
Trading Symbol | MSTX | ||
Entity Common Stock, Shares Outstanding | 192,836,367 | ||
Entity Public Float | $ 77 |
Consolidated Balance Sheets
Consolidated Balance Sheets - USD ($) $ in Thousands | Dec. 31, 2015 | Dec. 31, 2014 |
Current assets: | ||
Cash and cash equivalents | $ 23,052 | $ 35,808 |
Investment securities | 17,929 | 21,481 |
Prepaid expenses and other current assets | 1,271 | 1,114 |
Total current assets | 42,252 | 58,403 |
Property and equipment, net | 226 | 188 |
In-process research and development | 8,549 | 8,549 |
Goodwill | 3,007 | 3,007 |
Other assets | 183 | 353 |
Total assets | 54,217 | 70,500 |
Current liabilities: | ||
Accounts payable | 2,600 | 1,370 |
Accrued liabilities | 8,152 | 5,625 |
Accrued compensation and payroll taxes | 1,430 | 1,443 |
Debt facility | 10,991 | |
Total current liabilities | 23,173 | 8,438 |
Long-term lease obligation | 25 | |
Debt facility, net of current portion | 3,726 | |
Deferred income tax liability | 3,404 | 3,404 |
Total liabilities | $ 30,328 | $ 11,842 |
Commitments (Note 12) | ||
Stockholders' equity: | ||
Common stock, $0.001 par value; 500,000,000 shares authorized; 163,614,297 and 159,458,376 shares issued and outstanding at December 31, 2015 and 2014, respectively | $ 164 | $ 159 |
Additional paid-in capital | 298,715 | 293,655 |
Accumulated other comprehensive loss | (17) | (25) |
Accumulated deficit | (274,973) | (235,131) |
Total stockholders' equity | 23,889 | 58,658 |
Total liabilities and stockholders' equity | $ 54,217 | $ 70,500 |
Consolidated Balance Sheets (Pa
Consolidated Balance Sheets (Parenthetical) - $ / shares | Dec. 31, 2015 | Dec. 31, 2014 |
Statement Of Financial Position [Abstract] | ||
Common stock, par value | $ 0.001 | $ 0.001 |
Common stock, shares authorized | 500,000,000 | 500,000,000 |
Common stock, shares issued | 163,614,297 | 159,458,376 |
Common stock, shares outstanding | 163,614,297 | 159,458,376 |
Consolidated Statements of Oper
Consolidated Statements of Operations and Comprehensive Loss - USD ($) | 12 Months Ended | |
Dec. 31, 2015 | Dec. 31, 2014 | |
Income Statement [Abstract] | ||
Revenues | $ 0 | $ 0 |
Operating expenses: | ||
Research and development | 28,264,000 | 19,435,000 |
Selling, general and administrative | 10,963,000 | 9,488,000 |
Transaction-related expenses | 271,000 | |
Depreciation and amortization | 146,000 | 85,000 |
Total operating expenses | 39,373,000 | 29,279,000 |
Loss from operations | (39,373,000) | (29,279,000) |
Interest income | 130,000 | 69,000 |
Interest expense | (603,000) | |
Other income, net | 4,000 | 508,000 |
Net loss | $ (39,842,000) | $ (28,702,000) |
Net loss per share - basic and diluted | $ (0.25) | $ (0.23) |
Weighted average shares outstanding - basic and diluted | 162,219,116 | 122,409,183 |
Comprehensive Loss: | ||
Net loss | $ (39,842,000) | $ (28,702,000) |
Other comprehensive income/(loss) | 8,000 | (4,000) |
Comprehensive loss | $ (39,834,000) | $ (28,706,000) |
Consolidated Statements of Stoc
Consolidated Statements of Stockholders' Equity - USD ($) $ in Thousands | Total | Aires [Member] | Common Stock [Member] | Common Stock [Member]Aires [Member] | Additional Paid-in Capital [Member] | Additional Paid-in Capital [Member]Aires [Member] | Accumulated Other Comprehensive Loss [Member] | Accumulated Deficit [Member] |
Beginning balances at Dec. 31, 2013 | $ 47,808 | $ 103 | $ 254,155 | $ (21) | $ (206,429) | |||
Beginning balances, shares at Dec. 31, 2013 | 102,710,286 | |||||||
Net loss | (28,702) | (28,702) | ||||||
Sale of common stock and pre-funded warrants, net of offering costs | 34,254 | $ 51 | 34,203 | |||||
Sale of common stock and pre-funded warrants, net of offering costs, Shares | 51,644,288 | |||||||
Issuance of common stock in acquisition | $ 3,270 | $ 5 | $ 3,265 | |||||
Issuance of common stock in acquisition, shares | 5,103,702 | |||||||
Share-based compensation expense - employee options | 2,032 | 2,032 | ||||||
Warrant exercise | 0 | $ 0 | 0 | |||||
Warrant exercise, shares | 100 | |||||||
Other comprehensive income/(loss) | (4) | (4) | ||||||
Ending balances at Dec. 31, 2014 | 58,658 | $ 159 | 293,655 | (25) | (235,131) | |||
Ending balances, shares at Dec. 31, 2014 | 159,458,376 | |||||||
Net loss | (39,842) | (39,842) | ||||||
Sale of common stock, net of offering costs | 1,998 | $ 5 | 1,993 | |||||
Sale of common stock, net of offering costs, Shares | 4,155,921 | |||||||
Issuance of warrants in connection with debt facility | 392 | 392 | ||||||
Share-based compensation expense - employee options | 2,675 | 2,675 | ||||||
Other comprehensive income/(loss) | 8 | 8 | ||||||
Ending balances at Dec. 31, 2015 | $ 23,889 | $ 164 | $ 298,715 | $ (17) | $ (274,973) | |||
Ending balances, shares at Dec. 31, 2015 | 163,614,297 |
Consolidated Statements of Sto6
Consolidated Statements of Stockholders' Equity (Parenthetical) - USD ($) $ in Thousands | 12 Months Ended | |
Dec. 31, 2015 | Dec. 31, 2014 | |
Statement Of Stockholders Equity [Abstract] | ||
Sale of stock for common stock and pre funded warrants, offering costs | $ 2,095 | |
Sale of stock for Common stock, offering costs | $ 142 |
Consolidated Statements of Cash
Consolidated Statements of Cash Flows - USD ($) $ in Thousands | 12 Months Ended | |
Dec. 31, 2015 | Dec. 31, 2014 | |
Cash flows from operating activities: | ||
Net loss | $ (39,842) | $ (28,702) |
Adjustments to reconcile net loss to net cash used in operating activities: | ||
Depreciation and amortization | 146 | 85 |
Gain on bargain purchase | (486) | |
Share-based compensation expense related to employee stock options | 2,675 | 2,032 |
Write-off of fixed assets | 6 | |
Amortization of debt issuance costs and debt discount | 185 | |
Changes in assets and liabilities, net of effect of acquisitions: | ||
Increase/(decrease) in prepaid expenses and other assets | 13 | (58) |
Increase in accounts payable | 1,230 | 406 |
Increase in accrued liabilities | 2,638 | 2,078 |
Net cash used in operating activities | (32,949) | (24,645) |
Cash flows from investing activities: | ||
Purchases of certificates of deposit | (13,713) | (19,435) |
Proceeds from maturities of certificates of deposit | 17,024 | 16,659 |
Proceeds from sales of certificates of deposit | 249 | |
Purchases of property and equipment | (165) | (147) |
Security deposit for new lease | (130) | |
Cash obtained through acquisition | 3,534 | |
Net cash provided by investing activities | 3,395 | 481 |
Cash flows from financing activities: | ||
Proceeds from borrowings under debt facility | 15,000 | |
Costs paid in connection with debt facility | (193) | |
Proceeds from sale of common stock | 2,140 | 30,201 |
Proceeds from sale and exercise of warrants | 6,148 | |
Payments for offering costs | (142) | (2,058) |
Payments for capital lease | (7) | |
Net cash provided by financing activities | 16,798 | 34,291 |
Net (decrease)/increase in cash and cash equivalents | (12,756) | 10,127 |
Cash and cash equivalents at beginning of period | 35,808 | 25,681 |
Cash and cash equivalents at end of period | $ 23,052 | $ 35,808 |
Description of Business
Description of Business | 12 Months Ended |
Dec. 31, 2015 | |
Accounting Policies [Abstract] | |
Description of Business | 1. Description of Business Mast Therapeutics, Inc., a Delaware corporation (“Mast Therapeutics,” “we” or “our company”), is a biopharmaceutical company focused on developing clinical-stage therapies for serious or life-threatening diseases. We have devoted substantially all of our resources to research and development (“R&D”) and acquisition of our product candidates. We have not yet marketed or sold any products or generated any significant revenue. Through our acquisition of SynthRx, Inc. (“SynthRx”) in 2011, we acquired our Membrane Adhesion & Sealant Technology (MAST) platform, which includes proprietary poloxamer-related data and know-how developed over two decades of clinical, nonclinical and manufacturing experience, and we are leveraging the MAST platform to develop vepoloxamer (also known as MST-188) for serious or life-threatening diseases and conditions typically characterized by impaired microvascular blood flow and damaged cell membranes. Through our acquisition of Aires Pharmaceuticals, Inc. (“Aires”) in February 2014, we acquired AIR001, a sodium nitrite inhalation solution for intermittent inhalation via nebulization, which we are developing for the treatment of heart failure with preserved ejection fraction (HFpEF). The accompanying consolidated financial statements have been prepared on a going concern basis, which contemplates the realization of assets and the satisfaction of liabilities in the normal course of business. We have incurred significant operating losses since inception and have relied on our ability to fund our operations primarily though equity financings and a debt financing. For the years ended December 31, 2015 and 2014, we incurred losses from operations of $39.4 million and $29.3 million, respectively, and our net cash used in operating activities was $32.9 million and $24.6 million, respectively. At December 31, 2015, we had an accumulated deficit of $275.0 million, our cash, cash equivalents and investment securities totaled $41.0 million, and our working capital was $19.1 million. Given our planned operating activities in the case of positive results from the EPIC study that we determine will support proceeding with an NDA submission for vepoloxamer, our current cash, cash equivalents and investment securities balances, and our working capital, we intend to raise additional capital before the fourth quarter of 2016 through equity or debt financings and/or through collaborations, including licensing agreements. There can be no assurance that we will be successful in raising sufficient additional capital or that such capital, if available, will be on terms that are acceptable to us. Subject to limited exceptions, our loan and security agreement with Hercules prohibits us from incurring indebtedness without Hercules’ prior written consent. If we are unable to raise sufficient additional capital before the fourth quarter of 2016, or in the case of negative results from the EPIC study and prepayment to Hercules on July 31, 2016 of $10 million of the principal balance under our debt facility, we anticipate that we would immediately reduce the scope of our planned operations, including by delaying or discontinuing investment in development and commercialization efforts for vepoloxamer in sickle cell disease and heart failure. In this case, we expect that our cash, cash equivalents and investment securities as of December 31, 2015, together with the net proceeds from the underwritten public offering we completed in February 2016, would be sufficient to fund our operations, as reduced in scope, into the first quarter of 2017. Our business, operating results, financial condition, and growth prospects are subject to significant risks and uncertainties, including failing to obtain regulatory approval to commercialize our product candidates and failing to secure additional funding to complete development of and to successfully commercialize our product candidates. |
Summary of Significant Accounti
Summary of Significant Accounting Policies | 12 Months Ended |
Dec. 31, 2015 | |
Accounting Policies [Abstract] | |
Summary of Significant Accounting Policies | 2. Summary of Significant Accounting Policies Basis of Presentation The consolidated financial statements include the accounts of Mast Therapeutics and its wholly-owned subsidiaries, Aires and SD Pharmaceuticals, Inc. (“SD Pharmaceuticals”). All intercompany accounts and transactions have been eliminated in consolidation. We account for business combinations, such as our acquisitions of SynthRx in April 2011 and Aires in February 2014, in accordance with Accounting Standards Codification (“ASC”) Topic 805, Business Combinations Use of Estimates The preparation of financial statements in conformity with United States generally accepted accounting principles (“U.S. GAAP”) requires management to make estimates and assumptions that affect the amounts reported in our consolidated financial statements and accompanying notes. On an ongoing basis, we evaluate our estimates, including estimates related to R&D expenses, IPR&D, goodwill, and share-based compensation expenses. We base our estimates on historical experience and various other relevant assumptions we believe to be reasonable under the circumstances. Actual results may differ from these estimates. Fair Value of Financial Instruments Our investment securities and debt facility are carried at fair value (see Note 6). Cash equivalents, prepaid expenses and other current assets, accounts payable and accrued liabilities, are carried at cost, which we believe approximates fair value due to the short-term maturities of these instruments. Cash Equivalents We consider all highly liquid investments with original maturities of three months or less at the date of purchase to be cash equivalents. Cash equivalents are carried at cost, which we believe approximates fair value due to the short-term maturities of these instruments. At December 31, 2015 and 2014, we had $15.8 million and $16.6 million of cash equivalents, respectively. Investment Securities Investment securities are marketable equity or debt securities. All of our investment securities are “available-for-sale” securities and carried at fair value (see Note 6). Fair value for securities with short maturities and infrequent secondary market trades typically is determined by using a curve-based evaluation model that utilizes quoted prices for similar securities. The evaluation model takes into consideration the days to maturity, coupon rate and settlement date convention. Net unrealized gains or losses on these securities are included in accumulated other comprehensive income/(loss), which is a separate component of stockholders’ equity. Realized gains and realized losses are included in other income, net while amortization of premiums and accretion of discounts are included in interest income. Interest and dividends on available-for-sale securities are included in interest income. We periodically evaluate our investment securities for impairment. If we determine that a decline in fair value of any investment security is other than temporary, then the cost basis would be written down to fair value and the decline in value would be charged to earnings. Our investment securities are under the custodianship of a major financial institution and consist of FDIC-insured certificates of deposit. We have classified all of our available-for-sale investment securities, including those with maturities beyond one year from the date of purchase, as current assets on our consolidated balance sheets because we consider them to be highly liquid and available for use, if needed, in current operations. As of December 31, 2015, $2.7 million, or approximately 15%, of our investment securities had contractual maturity dates of more than one year and less than or equal to 18 months and none were greater than 18 months. Property and Equipment Property and equipment are stated at cost, less accumulated depreciation. Property and equipment are depreciated using the straight-line method over the estimated useful lives of the assets, which generally is three to five years. Leasehold improvements are amortized over the economic life of the asset or the lease term, whichever is shorter. Repairs and maintenance are expensed as incurred. In accordance with ASC Topic 360-10, Property, Plant and Equipment – Overall Intangible Assets – Goodwill and Acquired In-Process Research & Development In accordance with ASC Topic 350, Intangibles – Goodwill and Other Intangibles – Goodwill and Other (Topic 350): Testing Goodwill for Impairment Intangibles – Goodwill and Other (Topic 350): Testing Indefinite-Lived Intangible Assets for Impairment If we perform a quantitative assessment of goodwill, we utilize the two-step approach prescribed under ASC Topic 350. Step 1 requires a comparison of the carrying value of a reporting unit, including goodwill, to its estimated fair value. We test for impairment at the entity level because we operate on the basis of a single reporting unit. If our carrying value exceeds our fair value, we then perform Step 2 to measure the amount of impairment loss, if any. In Step 2, we estimate the fair value of our individual assets, including identifiable intangible assets, and liabilities to determine the implied fair value of goodwill. We then compare the carrying value of our goodwill to its implied fair value. The excess of the carrying value of goodwill over its implied fair value, if any, is recorded as an impairment charge. If we perform a quantitative assessment of acquired IPR&D, we calculate the estimated fair value of acquired IPR&D by using the Multi-Period Excess Earnings Method, or MPEEM, which is a form of the income approach. Under the MPEEM, the fair value of an intangible asset is equal to the present value of the asset’s projected incremental after-tax cash flows (excess earnings) remaining after deducting the market rates of return on the estimated value of contributory assets (contributory charge) over its remaining useful life. This method requires us to make long-term projections of revenues and expenses related to development and commercialization of the acquired assets and assumptions regarding the rate of return on contributory assets, the weighted average cost of capital and the probability adjustment factor for estimated future after-tax cash flows. The excess of the carrying value over its estimated fair value is recorded as an impairment charge. Any impairment charges are recorded to our consolidated statements of operations and comprehensive loss. Our determinations as to whether, and, if so, the extent to which, goodwill and acquired IPR&D become impaired are highly judgmental and based on significant assumptions regarding our projected future financial condition and operating results, changes in the manner of our use or development of the acquired assets, our overall business strategy, and regulatory, market and economic environment and trends. We perform our annual impairment testing as of September 30 each year, or, in the case of initially acquired IPR&D, on the first anniversary of the date we acquired it and subsequently on September 30. As of September 30, 2015, no impairment of goodwill or acquired IPR&D was identified. We are not aware of an event or change in circumstances that would indicate the carrying value may be impaired. Concentration of Credit Risk and Significant Sources of Supply Financial instruments that potentially subject us to concentrations of credit risk are primarily cash, cash equivalents and investment securities. We have a board-approved investment policy that sets our investment parameters and limitations with objectives of preserving principal and liquidity. Our cash and cash equivalent balances consist primarily of money market accounts under the custodianship of major financial institutions. Investment securities are invested in accordance with our investment policy. We do not have any financial instruments with off-balance-sheet risk of accounting loss. We rely on single-source, third-party manufacturers and suppliers for production and supply of key components of our product candidates, and for production of the final drug products themselves. If these single-source, third-party manufacturers and suppliers are unable to continue providing a key component or the final drug products, the initiation or progress of any clinical studies of our product candidates may be severely impeded. Research and Development Expense R&D costs are charged to expense as incurred and include, but are not limited to, clinical and nonclinical study costs, research-related manufacturing and related costs, employee salaries and benefits, consulting services fees and share-based compensation cost. Clinical study costs include, but are not limited to, clinical research organization fees, investigator fees, site costs and, as applicable, comparator drug costs. Costs for certain R&D activities, such as research-related manufacturing and clinical studies, are recognized based on an evaluation of the percentage of work completed or the progress to completion of specific tasks using data such as patient enrollment, clinical site activations, duration of the study and/or information provided to us by our vendors on their actual costs incurred. Payments for these activities are based on the terms of the individual arrangements, which may differ from the pattern of costs incurred, and are reflected in the financial statements as prepaid expenses or accrued R&D costs. Advance payments to third parties, including nonrefundable amounts, for goods and services that will be used or rendered for future R&D activities are deferred and capitalized, then expensed as the services are performed or as the underlying goods are delivered. If we do not expect the services to be rendered or goods to be delivered, any remaining capitalized amounts for nonrefundable advance payments are charged to expense immediately. Milestone payments that we make in connection with in-licensed technology or product candidates are expensed as incurred when there is uncertainty in receiving future economic benefits from the licensed technology or product candidates. We consider the future economic benefits from the licensed technology or product candidates to be uncertain until such licensed technology is incorporated into products that, or such product candidates, are approved for marketing by the FDA or when other significant risk factors are abated. For accounting purposes, management has viewed future economic benefits for all of our licensed technology or product candidates to be uncertain. Share-Based Compensation Share-based compensation cost is measured at the grant date, based on the estimated fair value of the award using the Black-Scholes valuation model, and is recognized as expense over the vesting period on a straight-line basis. Share-based compensation expense recognized in the consolidated statements of operations for the years ended December 31, 2015 and 2014 is based on awards ultimately expected to vest and has been reduced for estimated forfeitures. This estimate will be revised in subsequent periods if actual forfeitures differ from those estimates. None of our outstanding share-based awards have market or performance conditions. Patent Costs Legal costs and other fees incurred in connection with patent prosecution and maintenance are expensed as incurred, as recoverability of such expenditures is uncertain. These costs are recorded as selling, general and administrative expenses in our consolidated statement of operations and comprehensive loss. Income Taxes We account for income taxes and the related accounts under the liability method. Deferred tax assets and liabilities are determined based on the differences between the financial statement carrying amounts and the income tax basis of assets and liabilities. A valuation allowance is applied against any net deferred tax asset if, based on available evidence, it is more likely than not that some or all of the deferred tax assets will not be realized. The tax effects from an uncertain tax position can be recognized in our consolidated financial statements only if the position is more likely than not of being sustained upon an examination by tax authorities. An uncertain income tax position will not be recognized if it has less than a 50% likelihood of being sustained. We account for interest and penalties related to income tax matters, if any, in income tax expense. Comprehensive Income/(Loss) Comprehensive income or loss is defined as the change in equity of a business enterprise during a period from transactions and other events and circumstances from non-owner sources, including unrealized gains and losses on marketable securities and foreign currency translation adjustments. We present comprehensive income/(loss) in our consolidated statement of operations and comprehensive loss. Net Loss per Common Share Basic and diluted net loss per common share is calculated by dividing the net loss applicable to common stock for the periods presented by the weighted-average number of common shares outstanding during those periods, respectively, without consideration for outstanding common stock equivalents because their effect would have been anti-dilutive. Common stock equivalents are included in the calculation of diluted earnings per common share only if their effect is dilutive. For the years ended December 31, 2015 and 2014, our outstanding common stock equivalents consisted of options and warrants to purchase shares of our common stock. The weighted-average number of those common stock equivalents outstanding for each of the periods presented is set forth in the table below: Years ended December 31, 2015 2014 Warrants 77,355,271 49,217,355 Options 21,514,699 11,760,113 Supplemental Cash Flow Information Years ended December 31, 2015 2014 (in thousands) Cash paid for interest on debt facility 298 - Supplemental disclosures of non-cash investing and financing activities: Issuance of common stock for acquisitions - 3,270 Assumptions of liabilities in acquisitions - 1,069 Unrealized loss on investment securities (8 ) (4 ) Warrants issued in connection with debt facility 392 - Purchase of equipment under capital lease 40 - Purchases of property and equipment in accounts payable 2 17 Offering costs included in accounts payable - 36 Recent Accounting Pronouncements In February 2016, the Financial Accounting Standards Board (“FASB”) issued Accounting Standards Update (“ASU”) No. 2016-02, Leases (ASC 842) Leases In November 2015, the FASB issued ASU No. 2015-17, Balance Sheet Classification of Deferred Taxes In April 2015, the FASB issued ASU No. 2015-03, Simplifying the Presentation of Debt Issuance Costs In August 2014, the FASB issued ASU No. 2014-15, Presentation of Financial Statements - Going Concern (Subtopic 205-40): Disclosure of Uncertainties about an Entity’s Ability to Continue as a Going Concern |
Acquisition of Aires
Acquisition of Aires | 12 Months Ended |
Dec. 31, 2015 | |
Business Combinations [Abstract] | |
Acquisition of Aires | 3. Acquisition of Aires On February 27, 2014, we completed the acquisition of Aires in an all-stock transaction pursuant to the terms of an agreement and plan of merger, dated February 7, 2014, by and among us, AP Acquisition Sub, Inc., a wholly-owned subsidiary of ours, Aires, and a stockholders’ representative (the “Merger Agreement”). Aires was a clinical-stage company with its lead product candidate, AIR001 (sodium nitrite) inhalation solution, in Phase 2 studies in pulmonary hypertension. Aires survived the merger transaction as a wholly-owned subsidiary of ours. Upon completion of the merger, we issued an aggregate of 1,049,706 unregistered shares of our common stock to former Aires stockholders and, in September 2014 after the six-month “holdback” period, we issued an aggregate of 4,053,996 additional unregistered shares of our common stock to former Aires stockholders, all in accordance with the merger agreement. There are no milestone or earn-out payments under the merger agreement; therefore, the total merger consideration was 5,103,702 shares. We accounted for the acquisition of Aires in accordance with ASC Topic 805. The total purchase price of the acquisition is approximately $3.3 million. We calculated the purchase price by first multiplying the total number of shares of our common stock issued by $0.80, which was the closing price per share of our common stock on February 27, 2014, the acquisition date. Then, we applied a discount factor to account for lack of market liquidity due to the restrictions on transfer of the securities for a period of six months following the acquisition in accordance with stockholder agreements we entered into with the former Aires stockholders and the fact that the shares are unregistered and we have no obligation to register them for resale. Under the acquisition method of accounting, the total purchase price is allocated to Aires’ net tangible and intangible assets and liabilities based on their estimated fair values as of the acquisition date. The table below summarizes the estimated fair values of Aires’ net tangible and intangible assets and liabilities on the acquisition date (in thousands). Cash and cash equivalents $ 3,534 Prepaid expenses and other assets 86 In-process research and development 2,000 Total assets: 5,620 Accounts payable and accrued liabilities 1,069 Deferred tax liability 795 Total liabilities: 1,864 Net assets acquired $ 3,756 The estimated fair value of the net assets acquired exceeds the purchase price by approximately $0.5 million. Accordingly, we recognized the $0.5 million excess as a bargain purchase gain in other income/(expense), net in our condensed consolidated statements of operations and comprehensive income/(loss). We were able to realize a gain because Aires was in a distressed sale situation. Aires lacked sufficient capital to continue operations and was unable to secure additional capital in the timeframe it required. Acquired In-Process Research and Development Acquired IPR&D is the estimated fair value of the AIR001 program as of the acquisition date. We determined that the estimated fair value of the AIR001 program was $2.0 million as of the acquisition date using the Multi-Period Excess Earnings Method, or MPEEM, which is a form of the income approach. Under the MPEEM, the fair value of an intangible asset is equal to the present value of the asset’s projected incremental after-tax cash flows (excess earnings) remaining after deducting the market rates of return on the estimated value of contributory assets (contributory charge) over its remaining useful life. To calculate fair value of the AIR001 program under the MPEEM, we used probability-weighted, projected cash flows discounted at a rate considered appropriate given the significant inherent risks associated with drug development by clinical-stage companies. Cash flows were calculated based on estimated projections of revenues and expenses related to AIR001 and then reduced by a contributory charge on requisite assets employed. Contributory assets included debt-free working capital, net fixed assets and assembled workforce. Rates of return on the contributory assets were based on rates used for comparable market participants. Cash flows were assumed to extend through a seven-year market exclusivity period. The resultant cash flows were then discounted to present value using a weighted-average cost of capital for companies with profiles substantially similar to that of Aires, which we believe represents the rate that market participants would use to value the assets. We compensated for the phase of development of the program by applying a probability factor to our estimation of the expected future cash flows. The projected cash flows were based on significant assumptions, including the indication in which we will pursue development of AIR001, the time and resources needed to complete the development and regulatory approval of AIR001, estimates of revenue and operating profit related to the program considering its stage of development, the life of the potential commercialized product, market penetration and competition, and risks associated with achieving commercialization, including delay or failure to obtain regulatory approvals to conduct clinical studies, failure of clinical studies, delay or failure to obtain required market clearances, and intellectual property litigation. Deferred Income Tax Liability The $0.8 million recorded as deferred income tax liability resulting from the acquisition reflects the tax impact of the difference between the book basis and tax basis of acquired IPR&D. Such deferred income tax liability cannot be used to offset deferred tax assets when analyzing our valuation allowance as the acquired IPR&D is considered to have an indefinite life until we complete or abandon development of AIR001. |
Goodwill and IPR&D
Goodwill and IPR&D | 12 Months Ended |
Dec. 31, 2015 | |
Goodwill And Intangible Assets Disclosure [Abstract] | |
Goodwill and IPR&D | 4. Goodwill and IPR&D At December 31, 2015 and 2014, our goodwill and IPR&D consisted of the following (in thousands): Goodwill $ 3,007 IPR&D Acquired IPR&D related to SynthRx acquisition 6,549 Acquired IPR&D related to Aires acquisition 2,000 Total goodwill and IPR&D $ 11,556 Our goodwill represents the difference between the total purchase price for SynthRx and the aggregate fair values of tangible and intangible assets acquired, less liabilities assumed. Our IPR&D consists of the estimated fair values of the vepoloxamer and AIR001 programs as of the dates we acquired SynthRx and Aires, respectively. We test our goodwill and acquired IPR&D for impairment annually as of September 30, or, in the case of initially acquired IPR&D, on the first anniversary of the date we acquired it and subsequently on September 30, and between annual tests if we become aware of an event or a change in circumstances that would indicate the carrying value may be impaired. We performed a qualitative assessment for our goodwill and our acquired IPR&D as of September 30, 2015. We concluded that it is not more likely than not that the carrying value of our goodwill or our acquired IPR&D exceeds its fair value. Therefore, we concluded that no impairment charge is required. |
Investment Securities
Investment Securities | 12 Months Ended |
Dec. 31, 2015 | |
Investments Debt And Equity Securities [Abstract] | |
Investment Securities | 5. Investment Securities At December 31, 2015 and 2014, our investment securities were as follows (in thousands): December 31, 2015 2014 Fair value of investment securities $ 17,929 $ 21,481 Cost basis of investment securities 17,946 21,506 Years ended December 31, 2015 2014 Net unrealized losses on investment securities 17 25 |
Fair Value of Financial Instrum
Fair Value of Financial Instruments | 12 Months Ended |
Dec. 31, 2015 | |
Fair Value Disclosures [Abstract] | |
Fair Value of Financial Instruments | 6. Fair Value of Financial Instruments Our cash equivalents are recorded at cost plus accrued interest, which approximates fair value. Our investment securities are carried at fair value. The fair value of financial assets and liabilities is measured under a framework that establishes “levels” which are defined as follows: (i) Level 1 fair value is determined from observable, quoted prices in active markets for identical assets or liabilities; (ii) Level 2 fair value is determined from inputs, other than Level 1 inputs, that are observable, either directly or indirectly, such as quoted prices for similar assets or liabilities, quoted prices 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 asset or liability; and (iii) Level 3 fair value is determined using the entity’s own assumptions about the inputs that market participants would use in pricing an asset or liability. The fair values at December 31, 2015 and 2014 of our cash equivalents and investment securities are summarized in the following tables (in thousands): Fair Value Determined Under: Total Fair Value (Level 1) (Level 2) (Level 3) At December 31, 2015: Cash equivalents $ 15,799 $ 15,799 $ — $ — Investment securities $ 17,929 $ — $ 17,929 $ — At December 31, 2014: Cash equivalents $ 16,626 $ 16,626 $ — $ — Investment securities $ 21,481 $ — $ 21,481 $ — We believe that our debt facility bears interest at a rate that approximates prevailing market rates for instruments with similar characteristics and, accordingly, the carrying value of the debt facility approximates fair value. The fair value of our debt facility is determined under Level 2 in the fair value hierarchy. |
Property and Equipment
Property and Equipment | 12 Months Ended |
Dec. 31, 2015 | |
Property Plant And Equipment [Abstract] | |
Property and Equipment | 7. Property and Equipment Property and equipment at December 31, 2015 and 2014 were as follows (in thousands): December 31, Useful Lives 2015 2014 Office furniture, computer and lab equipment 3 - 5 years $ 493 $ 416 Computer software 3 years 16 58 Leasehold improvements 1 year 44 35 Equipment in progress n/a 12 23 565 532 Less: accumulated depreciation and amortization (339 ) (344 ) Property and equipment, net $ 226 $ 188 Equipment in progress represents the cost of lab equipment and/or leasehold improvements not yet available for service as of December 31, 2015 and 2014. These items are depreciated over their applicable useful lives once they are available for service. Depreciation and amortization expense was $146,000 and $85,000 for the years ended December 31, 2015 and 2014, respectively. We lease certain office equipment under leases classified as capital leases. As of December 31, 2015, the total amount of leased equipment was $40,000 with interest rates ranging from 8% to 14% per annum. The equipment is being amortized over the life of the leases, which range from three to five years. Future commitments under capital leases are as follows (in thousands): Year Ending December 31, 2016 11 2017 10 2018 10 2019 8 2020 - Thereafter - Total $ 39 Total imputed interest over the life of the capital leases is $8,000. |
Accrued Liabilities
Accrued Liabilities | 12 Months Ended |
Dec. 31, 2015 | |
Payables And Accruals [Abstract] | |
Accrued Liabilities | 8. Accrued Liabilities Accrued liabilities at December 31, 2015 and 2014 were as follows (in thousands): December 31, 2015 2014 Accrued R&D agreements and study expenses $ 7,898 $ 5,383 Other accrued liabilities 254 242 Total accrued liabilities $ 8,152 $ 5,625 |
Debt Facility
Debt Facility | 12 Months Ended |
Dec. 31, 2015 | |
Debt Disclosure [Abstract] | |
Debt Facility | 9. Debt Facility Hercules Loan and Security Agreement We have borrowed an aggregate of $15 million pursuant to a Loan and Security Agreement, dated August 11, 2015, with Hercules Technology III, L.P. and Hercules Capital, Inc. (formerly known as, Hercules Technology Growth Capital, Inc.) (together, “Hercules”), as amended by the First Amendment thereto dated September 28, 2015, the Second Amendment thereto dated December 31, 2015, and the Third Amendment thereto dated February 25, 2016, (collectively, the “Loan Agreement”). Pursuant to the terms and conditions of the Loan Agreement we received the first advance of $5 million on August 11, 2015 and the second advance of $10.0 million (the “Second Advance”) on September 28, 2015. Under the Loan Agreement, the Second Advance is required to be prepaid to Hercules on July 31, 2016, without any prepayment penalty, unless on or before such date, we demonstrate, to the reasonable satisfaction of Hercules, positive results in our Phase 3 clinical study of vepoloxamer in patients with sickle cell disease, known as the EPIC study. Due to numerous factors, we are not able to predict with any reasonable certainty the probability of meeting this condition by July 31, 2016; therefore, we have classified the Second Advance as a current liability on the balance sheet. The interest rate for the principal balance under the Loan Agreement is the greater of (i) 8.95% plus the prime rate as reported in The Wall Street Journal minus 3.25%, and (ii) 8.95%, determined on a daily basis. The interest rate as of December 31, 2015 was 9.20%. Monthly payments under the amended Loan Agreement are interest only until July 1, 2016, followed by equal monthly payments of principal and interest through the scheduled maturity date of January 1, 2019. The interest-only period will be extended to March 1, 2017 if we have demonstrated positive results in the EPIC study by July 1, 2016, we have not prepaid the Second Advance, and no event of default has occurred. If we demonstrate positive results in the EPIC study during the period between July 2, 2016 and July 31, 2016, inclusive, we have not prepaid the Second Advance and no event of default has occurred, then on July 1, 2016, we will be required to make a single payment against the principal balance of approximately $430,000 and, beginning August 1, 2016, we will resume making interest-only payments until March 1, 2017. If our interest-only payment period is extended to March 1, 2017, the maturity date would extend to October 1, 2019. An end of term charge of $712,500 will be due on the scheduled maturity date and is being accrued through interest expense using the effective interest method. If we elect to prepay the principal balance under the amended Loan Agreement prior to maturity, a prepayment charge of 1%, 2% or 3%, of the then outstanding principal balance also will be due, depending upon when the prepayment occurs. Our obligations under the amended Loan Agreement are secured by a first priority security interest in substantially all of our assets, excluding our intellectual property but including the proceeds from the sale, licensing or disposition of our intellectual property. Our intellectual property is subject to customary negative covenants. In connection with the Loan Agreement, through December 31, 2015, we had paid facility charges of $112,500 and a commitment charge of $25,000. Such charges were accounted for as debt issuance costs and are being amortized to interest expense using the effective interest method through the scheduled maturity date. In connection with the Loan Agreement, we entered into a Warrant Agreement with Hercules, dated August 11, 2015, as amended by the First Amendment thereto dated September 28, 2015 and the Second Amendment thereto dated February 25, 2016, pursuant to which Hercules has a right to purchase up to 2,272,727 shares of our common stock at an exercise price of $0.275 per share. Prior to the Second Amendment to Warrant Agreement and as of December 31, 2015, the Warrant Agreement, as amended, provided Hercules a right to purchase up to 1,524,390 shares of our common stock at an exercise price of $0.41 per share. The warrants issued to Hercules were valued using the Black-Scholes option pricing model with the following assumptions: volatility of 77%, expected term of five years, risk-free interest rate of 1.5% and a zero dividend yield. The warrant fair value of $0.4 million has been recorded as a debt discount and is being amortized through interest expense using the effective interest method through the scheduled maturity date. See Note 10 “Capital Stock and Warrants” and Note 17 “Subsequent Events” for further description of the terms of the warrants. Summary of Carrying Value The following table summarizes the components of the debt facility carrying value. As of December 31, 2015 Short-Term Long-Term Potential prepayment to lender $ 10,000 $ - Principal payments to lender and end of term charge 874 4,839 Accrued interest 117 - Debt issuance costs - (776 ) Debt discount related to warrants - (337 ) Carrying value $ 10,991 $ 3,726 |
Capital Stock and Warrants
Capital Stock and Warrants | 12 Months Ended |
Dec. 31, 2015 | |
Equity [Abstract] | |
Capital Stock and Warrants | 10. Capital Stock and Warrants Our certificate of incorporation, as amended, authorizes us to issue 500,000,000 shares of common stock, par value $0.001 per share, and 1,000,000 shares of preferred stock, par value $0.001 per share. As of December 31, 2015, 163,614,297 shares of common stock were outstanding and no shares of preferred stock were outstanding. Underwritten Public Offering of Common Stock, Pre-funded Warrants and Warrants In November 2014, we completed an underwritten public offering of 30,941,102 shares of our common stock, 13,081,428 “pre-funded” warrants exercisable for up to 13,081,428 shares of our common stock, and 22,011,265 warrants exercisable for up to 22,011,265 shares of our common stock. These securities were offered and sold to the underwriters and the public in units with each Series A unit consisting of one share of our common stock and one-half (0.5) of a warrant and each Series B unit consisting of one pre-funded warrant and one-half (0.5) of a warrant. Each whole warrant is exercisable for one share of our common stock. We sold an aggregate of 30,941,102 Series A units and 13,081,428 Series B units. The gross proceeds from this financing were $21.0 million and, after deducting underwriting discounts and commissions and other offering expenses, our net proceeds were $19.7 million. We may receive up to $0.1 million and $16.5 million of additional proceeds from the exercise of the pre-funded warrants and warrants, respectively, issued in the offering. The exercise price of the pre-funded warrants is $0.01 per share and exercise price of the warrants is $0.75 per share. Subject to certain beneficial ownership limitations, the pre-funded warrants and warrants are exercisable at any time on or before November 12, 2019. “At the Market” Equity Offering Program In February 2014, we entered into a sales agreement with Cowen and Company, LLC (“Cowen”), to sell shares of our common stock, with aggregate gross sales proceeds of up to $30 million, from time to time, through an “at the market,” or ATM, equity offering program (the “2014 Sales Agreement”), under which Cowen acted as sales agent. In August 2015, we terminated the 2014 Sales Agreement upon entry into a new sales agreement with Cowen to sell shares of our common stock, with aggregate gross sales proceeds of up to $30 million, from time to time, through an ATM program. As of December 31, 2015, we had sold and issued an aggregate of 24,859,107 shares at a weighted-average sales price of $0.70 per share under the ATM programs for aggregate gross proceeds of $17.5 million and $16.6 million in net proceeds, after deducting sales agent commission and discounts and our other offering costs. Warrants At December 31, 2015, outstanding warrants to purchase shares of common stock are as follows: Shares Underlying Outstanding Warrants Exercise Price Expiration Date 2,046,139 $ 2.75 January 2016 10,625,000 $ 1.10 November 2016 28,097,400 $ 0.65 June 2018 13,081,428 $ 0.01 November 2019 22,011,265 $ 0.75 November 2019 1,524,390 $ 0.41 August 2020 77,385,622 Warrants Issued to Hercules In connection with the Loan Agreement, we entered into a Warrant Agreement with Hercules Technology III, L.P., dated August 11, 2015, as amended by the First Amendment thereto dated September 28, 2015 and the Second Amendment thereto dated February 25, 2016, pursuant to which Hercules has a right to purchase up to 2,272,727 shares of our common stock at an exercise price of $0.275 per share. Prior to the Second Amendment to Warrant Agreement and as of December 31, 2015, the Warrant Agreement, as amended, provided Hercules a right to purchase up to 1,524,390 shares of our common stock at an exercise price of $0.41 per share. Hercules may exercise its warrants at any time, or from time to time, through August 11, 2020. The Warrant Agreement, as amended, provides for adjustment to the exercise price and number of shares subject to Hercules’ warrants in the event of a merger event, reclassification of our common stock, subdivision or combination of our common stock, or certain dividend payments. Upon exercise, the aggregate exercise price may be paid, at Hercules’ election, in cash or on a net issuance basis, based upon the fair market value of our common stock at the time of exercise. If the fair market value of our common stock is greater than the exercise price of the warrants as of immediately before their expiration, to the extent the warrants are not previously exercised in full, the warrants shall be deemed automatically exercised on a net issuance basis as of immediately before their expiration. |
Equity Incentive Plans
Equity Incentive Plans | 12 Months Ended |
Dec. 31, 2015 | |
Disclosure Of Compensation Related Costs Sharebased Payments [Abstract] | |
Equity Incentive Plans | 11. Equity Incentive Plans Our equity-based incentive plan, which is stockholder-approved, is intended to encourage ownership of shares of common stock by our directors, officers, employees, consultants and advisors and to provide additional incentive for them to promote the success of our business through the grant of share-based awards. At December 31, 2015, our equity-based incentive plan consisted of the 2005 Equity Incentive Plan (the “2005 Plan”) and the 2008 Omnibus Incentive Plan (the “Original 2008 Plan”), which has been amended, restated and renamed four times, first in June 2011 as the Amended and Restated 2008 Omnibus Incentive Plan, then in June 2013 as the 2013 Omnibus Incentive Plan, then in June 2014 as the 2014 Omnibus Incentive Plan and finally in June 2015 as the 2015 Omnibus Incentive Plan (the “2015 Plan”). Following approval by our stockholders of each amendment and restatement of the Original 2008 Plan, no awards have been or will be granted under the terms of the plan in effect immediately prior to such amendment and restatement. In prior years, our stockholder-approved, equity-based incentive plans included the 2005 Employee Stock Purchase Plan. In May 2015, our 2005 Employee Stock Purchase Plan, which had never been implemented, expired. During the years ended December 31, 2015 and 2014, all awards granted under our equity-based incentive plans were stock options. The share-based compensation expense from all stock options granted that has been charged to our consolidated statements of operations and comprehensive loss in those periods was as follows (in thousands): Years ended December 31, 2015 2014 Selling, general and administrative expense $ 2,077 $ 1,607 Research and development expense 598 425 Share-based compensation expense $ 2,675 $ 2,032 For the year ended December 31, 2015, we recognized a $0.3 million expense in our selling, general and administrative expenses related to share-based compensation expense as a result of the departure of our former president and chief operating officer in February 2015. Termination of the former officer’s employment triggered accelerated vesting of a portion of his outstanding, unvested stock options that resulted in $0.4 million of additional share-based compensation expense, but this additional expense was offset by a $0.1 million reduction in share-based compensation expense that resulted from cancellation of the remaining, unvested portion of the former officer’s outstanding stock options. 2015 Omnibus Incentive Plan The 2015 Plan provides for the grant of incentive and non-statutory stock options, as well as share appreciation rights, restricted shares, restricted share units, performance units, shares and other share-based awards. Share-based awards are subject to terms and conditions established by our board of directors or the compensation committee of our board of directors. As of December 31, 2015, the maximum aggregate number of shares of our common stock available for grant under the 2015 Plan was 21,583,541 shares. Shares of common stock that are subject to awards granted under the 2015 Plan shall be counted against the shares available for issuance under this plan as one share for each share subject to a stock option or stock appreciation right and as 1.34 shares for each share subject to an award other than a stock option or a stock appreciation right. If any shares of common stock subject to an award granted under any of our stockholder-approved, equity-based incentive plans are forfeited, or an award expires or is settled for cash pursuant to the terms of an award, the shares subject to the award may be used again for awards under the 2015 Plan to the extent of the forfeiture, expiration or cash settlement. The shares of common stock will be added back as one share for every share of common stock if the shares were subject to a stock option or stock appreciation right, and as 1.34 shares for every share of common stock if the shares were subject to an award other than a stock option or stock appreciation right. However, the following shares of common stock will not be added to the shares available for issuance under the 2015 Plan: (i) shares tendered or withheld in payment of the purchase price of a stock option, (ii) shares tendered or withheld to satisfy any tax withholding obligation with respect toany award, (iii) shares subject to a stock appreciation right that are not issued in connection with the stock settlement of the stock appreciation right on exercise thereof, and (iv) shares reacquired by us on the open market or otherwise using cash proceeds from the exercise of stock options. Shares of common stock under awards made in assumption of or in substitution or exchange for awards previously granted, or the right or obligation to make future awards, in each case by a company acquired by us, or with which we combine, will not reduce the number of shares available for issuance under the 2015 Plan. In addition, if a company acquired by us, or with which we combine, has shares available under a pre-existing plan approved by its stockholders and not adopted in contemplation of such acquisition or combination, the shares available for issuance under such plan (as adjusted, to the extent appropriate, using the exchange or other adjustment or valuation ratio of formula applied to determine the consideration payable to stockholders in the acquisition or combination) may be used for awards under the 2015 Plan and will not reduce the number of shares of common stock available for issuance under the 2015 Plan; provided, however that awards using such available shares shall not be made after the date awards or grants could have been made under the pre-existing plan, absent the acquisition or combination, and shall only be made to individuals who were not our employees or directors prior to the acquisition or combination. Under the 2015 Plan, the purchase price of shares of common stock covered by a stock option cannot be less than 100% of the fair market value of the common stock on the date the stock option is granted. Fair market value of the common stock is generally equal to the closing price for the common stock on the principal securities exchange on which the common stock is traded on the date the stock option is granted (or if there was no closing price on that date, on the last preceding date on which a closing price was reported). Stock option awards generally have ten-year contractual terms and vest over four years based on continuous service; however, the 2015 Plan allows for other vesting periods. Summary of 2015 Stock Option Activity The following table summarizes our stock option activity for the year ended December 31, 2015: Shares Underlying Option Awards Weighted-Average Exercise Price Weighted-Average Remaining Contractual Years Aggregate Intrinsic Value (in thousands) Outstanding at January 1, 2015 13,616,137 $ 1.00 Granted 13,114,372 $ 0.55 Exercised - $ — Expired/cancelled/forfeited (3,827,782 ) $ 0.65 Outstanding at December 31, 2015 22,902,727 $ 0.80 7.46 $ 4 Options exercisable at December 31, 2015 10,428,421 $ 1.10 5.72 $ - Vested and expected to vest at December 31, 2015 21,897,047 $ 0.81 7.38 $ 3 The weighted-average grant-date fair value of options granted during the years ended December 31, 2015 and 2014 was $0.42 and $0.50, respectively. As of December 31, 2015, there was approximately $4.6 million of unamortized compensation cost related to unvested stock option awards, which is expected to be recognized over a weighted-average period of approximately 2.8 years. Our determination of fair value is affected by our stock price as well as a number of assumptions that require judgment. The fair value of each option award is estimated on the date of grant using the Black-Scholes option-valuation model. The assumptions used in the Black-Scholes option-valuation model and the calculation of share-based compensation for option grants to employees and non-employee directors during the years ended December 31, 2015 and 2014 are as follows: Years ended December 31, 2015 2014 Risk-free interest rate 1.6 - 1.9% 1.9 - 2.1% Dividend yield 0.0% 0.0% Expected volatility 78 - 99% 104 - 112% Expected term (in years) 5.3 - 6.2 years 5.4 - 6.2 years Forfeiture rate 7 % 9% The risk-free interest rate assumption is based on the U.S. Treasury yield for a period consistent with the expected term of the option in effect at the time of the grant. We have not paid any dividends on common stock since our inception and do not anticipate paying dividends on our common stock in the foreseeable future. The expected option term is computed using the “simplified” method as permitted under the provisions of Staff Accounting Bulletin (“SAB”) 107. SAB 107’s guidance was extended indefinitely by SAB 110. The expected volatility is based on the historical volatility of our common stock based on the daily closing prices. Forfeiture rates are based on the expected forfeiture rates for our unvested stock options, which are based in large part on our historical forfeiture rates, but also on assumptions believed to be reasonable under the circumstances. In accordance with ASC 718, Compensation – Stock Compensation |
Commitments
Commitments | 12 Months Ended |
Dec. 31, 2015 | |
Commitments And Contingencies Disclosure [Abstract] | |
Commitments | 12. Commitments SynthRx Merger Consideration Milestone Payments In April 2011, we acquired SynthRx in a merger transaction in exchange of shares of our common stock and rights to additional shares of our common stock. Pursuant to the merger agreement, we could issue up to an aggregate of 12,478,050 shares of our common stock to the former SynthRx stockholders if and when the development of vepoloxamer achieves the following milestones: (a) 3,839,400 shares upon acceptance for review by the U.S. Food and Drug Administration (“FDA”) of a new drug application (“NDA”) covering the use of vepoloxamer for the treatment of sickle cell crisis in children and (b) 8,638,650 shares upon approval of such NDA by the FDA. Operating Leases We are obligated under operating leases for office space and equipment. We sublease approximately 13,700 square feet of office space for our corporate headquarters in San Diego, California. Our sublease commenced on January 20, 2015 and expires on May 31, 2020. Our monthly rent of $41,000 escalates by 3% each year on January 20 th We lease office equipment under a lease that expires in 2019. Rent expense was approximately $508,000 and $334,000 during the years ended December 31, 2015 and 2014, respectively. Future rental commitments under all operating leases are as follows (in thousands): Year Ending December 31, 2016 $ 389 2017 489 2018 547 2019 557 2020 237 Thereafter - Total $ 2,219 |
Income Taxes
Income Taxes | 12 Months Ended |
Dec. 31, 2015 | |
Income Tax Disclosure [Abstract] | |
Income Taxes | 13. Income Taxes Due to our historical net loss position, and as we have recorded a full valuation allowance against net deferred tax assets, there is no provision or benefit for income taxes recorded for the years ended December 31, 2015 and 2014. The income tax benefit is different from that which would be obtained by applying the statutory Federal income tax rate of 34% to income before income tax expense. The items causing this difference for the years ended December 31, 2015 and 2014 are as follows: Years ended December 31, 2015 2014 (in thousands) Income tax benefit at federal statutory rate $ (13,546 ) $ (9,758 ) Orphan drug credit / R&D credit (7,530 ) (4,575 ) Stock options 594 278 Other 187 (213 ) Change in federal valuation allowance 20,295 14,268 Total $ - $ - Deferred income taxes reflect the net tax effect of temporary differences between the carrying amount of assets and liabilities for financial reporting purposes and the amounts used for income tax purposes. Significant components of deferred tax assets and liabilities at December 31, 2015 and 2014 are as follows: Years ended December 31, 2015 2014 (in thousands) Deferred tax assets: Accrued expenses $ 619 $ 592 Stock options under ASC 718 2,610 2,240 Net operating loss carry forwards 31,649 20,583 Income tax credit carry forwards 19,369 8,109 Property and equipment 20 12 Intangibles 895 1,793 Other 69 33 Total deferred tax assets 55,231 33,362 Less: valuation allowance (55,231 ) (33,362 ) Total deferred tax assets, net of valuation allowance $ - $ - Deferred tax liabilities: Acquired intangibles (3,404 ) (3,404 ) Total deferred tax assets/liabilities, net of valuation allowance $ (3,404 ) $ (3,404 ) We have established a full valuation allowance against our net deferred tax assets due to uncertainty surrounding the realization of such assets. Management has determined it is more likely than not that the deferred tax assets are not realizable due to our historical loss position. As a result of our acquisitions of SynthRx and Aires during 2011 and 2014, respectively, we recorded deferred tax liabilities. These deferred tax liabilities reflect the tax impact of the differences between the book basis and tax basis of acquired IPR&D that has not yet reached feasibility. Such deferred tax liabilities cannot be used to offset deferred tax assets when analyzing our end of year valuation allowance as the acquired IPR&D is considered to have an indefinite life until we complete or abandon development. The deferred tax liabilities were recorded as an offset to goodwill or gain on bargain purchase, recorded as part of the SynthRx and Aires acquisitions, respectively. Sections 382 and 383 of the Internal Revenue Code of 1986, as amended, or IRC, limit our ability to use net operating loss carry forwards and R&D tax credit carry forwards (“tax attribute carry forwards”) to offset future taxable income or income tax, respectively, if we experience a cumulative change in ownership of more than 50% within a three-year testing period. We completed a formal study through the year ended December 31, 2011 and determined ownership changes within the meaning of IRC Section 382 had occurred. We adjusted our tax attribute carry forwards and deferred tax assets accordingly. As the deferred tax assets associated with the tax attribute carry forwards were fully offset by a valuation allowance, a corresponding reduction in the Company’s valuation allowance was also recorded, resulting in no income tax impact. We completed a formal study to determine whether an ownership change, within the meaning of IRC Section 382, occurred during 2012, 2013 or 2014, and no ownership changes were identified. As of December 31, 2015, we had federal and California net operating loss carry forwards of $80.3 million and $74.4 million, respectively. These tax loss carry forwards begin to expire in 2031 if unused. As of December 31, 2015, we also had federal R&D/orphan drug and California R&D tax credit carry forwards of $18.8 million and $0.9 million, respectively. The aforementioned federal tax credits will begin to expire in 2031. The California R&D tax credits do not expire. In accordance with authoritative guidance, the impact of an uncertain income tax position on the income tax return must be recognized at the largest amount that is more-likely-than-not to be sustained upon audit by the relevant taxing authority. An uncertain income tax position will not be recognized if it has less than a 50% likelihood of being sustained. As of December 31, 2015, we continue to have no unrecognized tax benefits. There are no unrecognized tax benefits included on the balance sheet that would, if recognized, impact the effective tax rate. We do not anticipate there will be a significant change in unrecognized tax benefits within the next 12 months. Our policy is to recognize interest and/or penalties related to income tax matters in income tax expense. Because we have generated net operating losses since inception, no tax liability, penalties or interest has been recognized for balance sheet or income statement purposes as of and for the years ended December 31, 2015 and 2014. We are subject to income taxation in the U.S. and the state of California. All of our tax years are subject to examination by the tax authorities due to the carry forward of unutilized net operating losses and R&D tax credits. |
401(k) Plan
401(k) Plan | 12 Months Ended |
Dec. 31, 2015 | |
Compensation And Retirement Disclosure [Abstract] | |
401(k) Plan | 14. 401(k) Plan We have a defined contribution savings plan pursuant to Section 401(k) of the IRC. The plan is for the benefit of all qualifying employees and permits voluntary contributions by employees up to 100% of eligible compensation, subject to the Internal Revenue Service (“IRS”) imposed maximum limits. The terms of the plan require us to make matching contributions equal to 100% of employee contributions up to 6% of eligible compensation, limited by the IRS-imposed maximum. We incurred total expenses of $246,000 and $212,000 in employer matching contributions in 2015 and 2014, respectively. |
Segment Information
Segment Information | 12 Months Ended |
Dec. 31, 2015 | |
Segment Reporting [Abstract] | |
Segment Information | 15. Segment Information We operate our business on the basis of a single reportable segment, which is the business of developing therapies for serious or life-threatening diseases. We evaluate our Company as a single operating segment. The majority of our operating activities and work performed by our employees are currently conducted from a single location in the U.S. We recognized no revenues in 2015 and 2014. |
Summary of Quarterly Financial
Summary of Quarterly Financial Data (unaudited) | 12 Months Ended |
Dec. 31, 2015 | |
Quarterly Financial Information Disclosure [Abstract] | |
Summary of Quarterly Financial Data (unaudited) | 16. Summary of Quarterly Financial Data (unaudited) The following is a summary of the unaudited quarterly results of operations for the years ended December 31, 2015 and 2014 (in thousands, except per share data): Quarterly statements of operations data Quarters Ended 2015 (unaudited) March 31 June 30 September 30 December 31 Revenue $ - $ - $ - $ - Loss from operations (9,650 ) (10,181 ) (9,828 ) (9,714 ) Net loss (9,616 ) (10,151 ) (9,912 ) (10,162 ) Net loss applicable to common stock (9,616 ) (10,151 ) (9,912 ) (10,162 ) Basic and diluted net loss per share $ (0.06 ) $ (0.06 ) $ (0.06 ) $ (0.06 ) Basic and diluted weighted average number of shares of common stock outstanding 159,459 162,128 163,614 163,614 Quarters Ended 2014 (unaudited) March 31 June 30 September 30 December 31 Revenue $ - $ - $ - $ - Loss from operations (6,839 ) (7,202 ) (7,884 ) (7,354 ) Net loss (6,371 ) (7,152 ) (7,866 ) (7,313 ) Net loss applicable to common stock (6,371 ) (7,152 ) (7,866 ) (7,313 ) Basic and diluted net loss per share $ (0.06 ) $ (0.06 ) $ (0.06 ) $ (0.05 ) Basic and diluted weighted average number of shares of common stock outstanding 105,054 115,587 123,287 145,257 |
Subsequent Events
Subsequent Events | 12 Months Ended |
Dec. 31, 2015 | |
Subsequent Events [Abstract] | |
Subsequent Events | 17. Subsequent Events Underwritten Public Offering of Common Stock In February 2016, we completed an underwritten public offering with gross proceeds of $8.0 million from the sale and issuance of 29,090,910 units, each consisting of one share of our common stock and one warrant to purchase one share of our common stock. Net proceeds, after deducting underwriting discounts and commissions and other estimated offering expenses, were approximately $7.3 million. The warrants have an exercise price of $0.42 per share, are exercisable any time on or after August 17, 2016 and will expire on February 16, 2021. Amendments to Loan and Security Agreement and Warrant Agreement with Hercules In February 2016, we entered into a Third Amendment to Loan and Security Agreement primarily to amend the conditions under which we are required to prepay $10 million of the principal balance and the deadline for meeting the required condition, as well as to extend the interest-only payment period and provide for further extension of the interest-only payment period under certain circumstances. Pursuant to the Third Amendment to Loan Agreement, we paid an additional facility charge to Hercules of $37,500 and agreed to further amend our Warrant Agreement with Hercules Technology III, L.P. See Note 9 “Debt Facility” for additional information. In February 2016, in connection with the Third Amendment to Loan and Security Agreement, we entered into a Second Amendment to Warrant Agreement with Hercules Technology III, L.P. Pursuant to the Second Amendment to Warrant Agreement, the warrant issued to Hercules was amended such that the exercise price was decreased from $0.41 per share to $0.275 per share, resulting in the warrant becoming exercisable for an additional 748,337 shares of our common stock, for a total of up to 2,272,727 shares of our common stock. See Note 9 “Debt Facility” and Note 10 “Capital Stock and Warrants” for additional information. |
Summary of Significant Accoun25
Summary of Significant Accounting Policies (Policies) | 12 Months Ended |
Dec. 31, 2015 | |
Accounting Policies [Abstract] | |
Basis of Presentation | Basis of Presentation The consolidated financial statements include the accounts of Mast Therapeutics and its wholly-owned subsidiaries, Aires and SD Pharmaceuticals, Inc. (“SD Pharmaceuticals”). All intercompany accounts and transactions have been eliminated in consolidation. We account for business combinations, such as our acquisitions of SynthRx in April 2011 and Aires in February 2014, in accordance with Accounting Standards Codification (“ASC”) Topic 805, Business Combinations |
Use of Estimates | Use of Estimates The preparation of financial statements in conformity with United States generally accepted accounting principles (“U.S. GAAP”) requires management to make estimates and assumptions that affect the amounts reported in our consolidated financial statements and accompanying notes. On an ongoing basis, we evaluate our estimates, including estimates related to R&D expenses, IPR&D, goodwill, and share-based compensation expenses. We base our estimates on historical experience and various other relevant assumptions we believe to be reasonable under the circumstances. Actual results may differ from these estimates. |
Fair Value of Financial Instruments | Fair Value of Financial Instruments Our investment securities and debt facility are carried at fair value (see Note 6). Cash equivalents, prepaid expenses and other current assets, accounts payable and accrued liabilities, are carried at cost, which we believe approximates fair value due to the short-term maturities of these instruments. |
Cash Equivalents | Cash Equivalents We consider all highly liquid investments with original maturities of three months or less at the date of purchase to be cash equivalents. Cash equivalents are carried at cost, which we believe approximates fair value due to the short-term maturities of these instruments. At December 31, 2015 and 2014, we had $15.8 million and $16.6 million of cash equivalents, respectively. |
Investment Securities | Investment Securities Investment securities are marketable equity or debt securities. All of our investment securities are “available-for-sale” securities and carried at fair value (see Note 6). Fair value for securities with short maturities and infrequent secondary market trades typically is determined by using a curve-based evaluation model that utilizes quoted prices for similar securities. The evaluation model takes into consideration the days to maturity, coupon rate and settlement date convention. Net unrealized gains or losses on these securities are included in accumulated other comprehensive income/(loss), which is a separate component of stockholders’ equity. Realized gains and realized losses are included in other income, net while amortization of premiums and accretion of discounts are included in interest income. Interest and dividends on available-for-sale securities are included in interest income. We periodically evaluate our investment securities for impairment. If we determine that a decline in fair value of any investment security is other than temporary, then the cost basis would be written down to fair value and the decline in value would be charged to earnings. Our investment securities are under the custodianship of a major financial institution and consist of FDIC-insured certificates of deposit. We have classified all of our available-for-sale investment securities, including those with maturities beyond one year from the date of purchase, as current assets on our consolidated balance sheets because we consider them to be highly liquid and available for use, if needed, in current operations. As of December 31, 2015, $2.7 million, or approximately 15%, of our investment securities had contractual maturity dates of more than one year and less than or equal to 18 months and none were greater than 18 months. |
Property and Equipment | Property and Equipment Property and equipment are stated at cost, less accumulated depreciation. Property and equipment are depreciated using the straight-line method over the estimated useful lives of the assets, which generally is three to five years. Leasehold improvements are amortized over the economic life of the asset or the lease term, whichever is shorter. Repairs and maintenance are expensed as incurred. In accordance with ASC Topic 360-10, Property, Plant and Equipment – Overall |
Intangible Assets - Goodwill and Acquired In-Process Research & Development | Intangible Assets – Goodwill and Acquired In-Process Research & Development In accordance with ASC Topic 350, Intangibles – Goodwill and Other Intangibles – Goodwill and Other (Topic 350): Testing Goodwill for Impairment Intangibles – Goodwill and Other (Topic 350): Testing Indefinite-Lived Intangible Assets for Impairment If we perform a quantitative assessment of goodwill, we utilize the two-step approach prescribed under ASC Topic 350. Step 1 requires a comparison of the carrying value of a reporting unit, including goodwill, to its estimated fair value. We test for impairment at the entity level because we operate on the basis of a single reporting unit. If our carrying value exceeds our fair value, we then perform Step 2 to measure the amount of impairment loss, if any. In Step 2, we estimate the fair value of our individual assets, including identifiable intangible assets, and liabilities to determine the implied fair value of goodwill. We then compare the carrying value of our goodwill to its implied fair value. The excess of the carrying value of goodwill over its implied fair value, if any, is recorded as an impairment charge. If we perform a quantitative assessment of acquired IPR&D, we calculate the estimated fair value of acquired IPR&D by using the Multi-Period Excess Earnings Method, or MPEEM, which is a form of the income approach. Under the MPEEM, the fair value of an intangible asset is equal to the present value of the asset’s projected incremental after-tax cash flows (excess earnings) remaining after deducting the market rates of return on the estimated value of contributory assets (contributory charge) over its remaining useful life. This method requires us to make long-term projections of revenues and expenses related to development and commercialization of the acquired assets and assumptions regarding the rate of return on contributory assets, the weighted average cost of capital and the probability adjustment factor for estimated future after-tax cash flows. The excess of the carrying value over its estimated fair value is recorded as an impairment charge. Any impairment charges are recorded to our consolidated statements of operations and comprehensive loss. Our determinations as to whether, and, if so, the extent to which, goodwill and acquired IPR&D become impaired are highly judgmental and based on significant assumptions regarding our projected future financial condition and operating results, changes in the manner of our use or development of the acquired assets, our overall business strategy, and regulatory, market and economic environment and trends. We perform our annual impairment testing as of September 30 each year, or, in the case of initially acquired IPR&D, on the first anniversary of the date we acquired it and subsequently on September 30. As of September 30, 2015, no impairment of goodwill or acquired IPR&D was identified. We are not aware of an event or change in circumstances that would indicate the carrying value may be impaired. |
Concentration of Credit Risk and Significant Sources of Supply | Concentration of Credit Risk and Significant Sources of Supply Financial instruments that potentially subject us to concentrations of credit risk are primarily cash, cash equivalents and investment securities. We have a board-approved investment policy that sets our investment parameters and limitations with objectives of preserving principal and liquidity. Our cash and cash equivalent balances consist primarily of money market accounts under the custodianship of major financial institutions. Investment securities are invested in accordance with our investment policy. We do not have any financial instruments with off-balance-sheet risk of accounting loss. We rely on single-source, third-party manufacturers and suppliers for production and supply of key components of our product candidates, and for production of the final drug products themselves. If these single-source, third-party manufacturers and suppliers are unable to continue providing a key component or the final drug products, the initiation or progress of any clinical studies of our product candidates may be severely impeded. |
Research and Development Expense | Research and Development Expense R&D costs are charged to expense as incurred and include, but are not limited to, clinical and nonclinical study costs, research-related manufacturing and related costs, employee salaries and benefits, consulting services fees and share-based compensation cost. Clinical study costs include, but are not limited to, clinical research organization fees, investigator fees, site costs and, as applicable, comparator drug costs. Costs for certain R&D activities, such as research-related manufacturing and clinical studies, are recognized based on an evaluation of the percentage of work completed or the progress to completion of specific tasks using data such as patient enrollment, clinical site activations, duration of the study and/or information provided to us by our vendors on their actual costs incurred. Payments for these activities are based on the terms of the individual arrangements, which may differ from the pattern of costs incurred, and are reflected in the financial statements as prepaid expenses or accrued R&D costs. Advance payments to third parties, including nonrefundable amounts, for goods and services that will be used or rendered for future R&D activities are deferred and capitalized, then expensed as the services are performed or as the underlying goods are delivered. If we do not expect the services to be rendered or goods to be delivered, any remaining capitalized amounts for nonrefundable advance payments are charged to expense immediately. Milestone payments that we make in connection with in-licensed technology or product candidates are expensed as incurred when there is uncertainty in receiving future economic benefits from the licensed technology or product candidates. We consider the future economic benefits from the licensed technology or product candidates to be uncertain until such licensed technology is incorporated into products that, or such product candidates, are approved for marketing by the FDA or when other significant risk factors are abated. For accounting purposes, management has viewed future economic benefits for all of our licensed technology or product candidates to be uncertain. |
Share-Based Compensation | Share-Based Compensation Share-based compensation cost is measured at the grant date, based on the estimated fair value of the award using the Black-Scholes valuation model, and is recognized as expense over the vesting period on a straight-line basis. Share-based compensation expense recognized in the consolidated statements of operations for the years ended December 31, 2015 and 2014 is based on awards ultimately expected to vest and has been reduced for estimated forfeitures. This estimate will be revised in subsequent periods if actual forfeitures differ from those estimates. None of our outstanding share-based awards have market or performance conditions. |
Patent Costs | Patent Costs Legal costs and other fees incurred in connection with patent prosecution and maintenance are expensed as incurred, as recoverability of such expenditures is uncertain. These costs are recorded as selling, general and administrative expenses in our consolidated statement of operations and comprehensive loss. |
Income Taxes | Income Taxes We account for income taxes and the related accounts under the liability method. Deferred tax assets and liabilities are determined based on the differences between the financial statement carrying amounts and the income tax basis of assets and liabilities. A valuation allowance is applied against any net deferred tax asset if, based on available evidence, it is more likely than not that some or all of the deferred tax assets will not be realized. The tax effects from an uncertain tax position can be recognized in our consolidated financial statements only if the position is more likely than not of being sustained upon an examination by tax authorities. An uncertain income tax position will not be recognized if it has less than a 50% likelihood of being sustained. We account for interest and penalties related to income tax matters, if any, in income tax expense. |
Comprehensive Income/(Loss) | Comprehensive Income/(Loss) Comprehensive income or loss is defined as the change in equity of a business enterprise during a period from transactions and other events and circumstances from non-owner sources, including unrealized gains and losses on marketable securities and foreign currency translation adjustments. We present comprehensive income/(loss) in our consolidated statement of operations and comprehensive loss. |
Net Loss per Common Share | Net Loss per Common Share Basic and diluted net loss per common share is calculated by dividing the net loss applicable to common stock for the periods presented by the weighted-average number of common shares outstanding during those periods, respectively, without consideration for outstanding common stock equivalents because their effect would have been anti-dilutive. Common stock equivalents are included in the calculation of diluted earnings per common share only if their effect is dilutive. For the years ended December 31, 2015 and 2014, our outstanding common stock equivalents consisted of options and warrants to purchase shares of our common stock. The weighted-average number of those common stock equivalents outstanding for each of the periods presented is set forth in the table below: Years ended December 31, 2015 2014 Warrants 77,355,271 49,217,355 Options 21,514,699 11,760,113 |
Supplemental Cash Flow Information | Supplemental Cash Flow Information Years ended December 31, 2015 2014 (in thousands) Cash paid for interest on debt facility 298 - Supplemental disclosures of non-cash investing and financing activities: Issuance of common stock for acquisitions - 3,270 Assumptions of liabilities in acquisitions - 1,069 Unrealized loss on investment securities (8 ) (4 ) Warrants issued in connection with debt facility 392 - Purchase of equipment under capital lease 40 - Purchases of property and equipment in accounts payable 2 17 Offering costs included in accounts payable - 36 |
Recent Accounting Pronouncements | Recent Accounting Pronouncements In February 2016, the Financial Accounting Standards Board (“FASB”) issued Accounting Standards Update (“ASU”) No. 2016-02, Leases (ASC 842) Leases In November 2015, the FASB issued ASU No. 2015-17, Balance Sheet Classification of Deferred Taxes In April 2015, the FASB issued ASU No. 2015-03, Simplifying the Presentation of Debt Issuance Costs In August 2014, the FASB issued ASU No. 2014-15, Presentation of Financial Statements - Going Concern (Subtopic 205-40): Disclosure of Uncertainties about an Entity’s Ability to Continue as a Going Concern |
Summary of Significant Accoun26
Summary of Significant Accounting Policies (Tables) | 12 Months Ended |
Dec. 31, 2015 | |
Accounting Policies [Abstract] | |
Weighted-average Number of Those Common Stock Equivalents Outstanding | The weighted-average number of those common stock equivalents outstanding for each of the periods presented is set forth in the table below: Years ended December 31, 2015 2014 Warrants 77,355,271 49,217,355 Options 21,514,699 11,760,113 |
Supplemental Cash Flow Information | Years ended December 31, 2015 2014 (in thousands) Cash paid for interest on debt facility 298 - Supplemental disclosures of non-cash investing and financing activities: Issuance of common stock for acquisitions - 3,270 Assumptions of liabilities in acquisitions - 1,069 Unrealized loss on investment securities (8 ) (4 ) Warrants issued in connection with debt facility 392 - Purchase of equipment under capital lease 40 - Purchases of property and equipment in accounts payable 2 17 Offering costs included in accounts payable - 36 |
Acquisition of Aires (Tables)
Acquisition of Aires (Tables) | 12 Months Ended |
Dec. 31, 2015 | |
Business Combinations [Abstract] | |
Summary of Preliminary Estimated Fair Values of Net Tangible and Intangible Assets and Liabilities | The table below summarizes the estimated fair values of Aires’ net tangible and intangible assets and liabilities on the acquisition date (in thousands). Cash and cash equivalents $ 3,534 Prepaid expenses and other assets 86 In-process research and development 2,000 Total assets: 5,620 Accounts payable and accrued liabilities 1,069 Deferred tax liability 795 Total liabilities: 1,864 Net assets acquired $ 3,756 |
Goodwill and IPR&D (Tables)
Goodwill and IPR&D (Tables) | 12 Months Ended |
Dec. 31, 2015 | |
Goodwill And Intangible Assets Disclosure [Abstract] | |
Summary of Goodwill and IPR&D | At December 31, 2015 and 2014, our goodwill and IPR&D consisted of the following (in thousands): Goodwill $ 3,007 IPR&D Acquired IPR&D related to SynthRx acquisition 6,549 Acquired IPR&D related to Aires acquisition 2,000 Total goodwill and IPR&D $ 11,556 |
Investment Securities (Tables)
Investment Securities (Tables) | 12 Months Ended |
Dec. 31, 2015 | |
Investments Debt And Equity Securities [Abstract] | |
Investment Securities | At December 31, 2015 and 2014, our investment securities were as follows (in thousands): December 31, 2015 2014 Fair value of investment securities $ 17,929 $ 21,481 Cost basis of investment securities 17,946 21,506 Years ended December 31, 2015 2014 Net unrealized losses on investment securities 17 25 |
Fair Value of Financial Instr30
Fair Value of Financial Instruments (Tables) | 12 Months Ended |
Dec. 31, 2015 | |
Fair Value Disclosures [Abstract] | |
Fair Values of Cash Equivalents and Investment Securities | The fair values at December 31, 2015 and 2014 of our cash equivalents and investment securities are summarized in the following tables (in thousands): Fair Value Determined Under: Total Fair Value (Level 1) (Level 2) (Level 3) At December 31, 2015: Cash equivalents $ 15,799 $ 15,799 $ — $ — Investment securities $ 17,929 $ — $ 17,929 $ — At December 31, 2014: Cash equivalents $ 16,626 $ 16,626 $ — $ — Investment securities $ 21,481 $ — $ 21,481 $ — |
Property and Equipment (Tables)
Property and Equipment (Tables) | 12 Months Ended |
Dec. 31, 2015 | |
Property Plant And Equipment [Abstract] | |
Property and Equipment | Property and equipment at December 31, 2015 and 2014 were as follows (in thousands): December 31, Useful Lives 2015 2014 Office furniture, computer and lab equipment 3 - 5 years $ 493 $ 416 Computer software 3 years 16 58 Leasehold improvements 1 year 44 35 Equipment in progress n/a 12 23 565 532 Less: accumulated depreciation and amortization (339 ) (344 ) Property and equipment, net $ 226 $ 188 |
Future Commitments Under Capital Leases | Future commitments under capital leases are as follows (in thousands): Year Ending December 31, 2016 11 2017 10 2018 10 2019 8 2020 - Thereafter - Total $ 39 |
Accrued Liabilities (Tables)
Accrued Liabilities (Tables) | 12 Months Ended |
Dec. 31, 2015 | |
Payables And Accruals [Abstract] | |
Accrued Liabilities | Accrued liabilities at December 31, 2015 and 2014 were as follows (in thousands): December 31, 2015 2014 Accrued R&D agreements and study expenses $ 7,898 $ 5,383 Other accrued liabilities 254 242 Total accrued liabilities $ 8,152 $ 5,625 |
Debt Facility (Tables)
Debt Facility (Tables) | 12 Months Ended |
Dec. 31, 2015 | |
Debt Disclosure [Abstract] | |
Summary of Components of Debt Facility Carrying Value | The following table summarizes the components of the debt facility carrying value. As of December 31, 2015 Short-Term Long-Term Potential prepayment to lender $ 10,000 $ - Principal payments to lender and end of term charge 874 4,839 Accrued interest 117 - Debt issuance costs - (776 ) Debt discount related to warrants - (337 ) Carrying value $ 10,991 $ 3,726 |
Capital Stock and Warrants (Tab
Capital Stock and Warrants (Tables) | 12 Months Ended |
Dec. 31, 2015 | |
Equity [Abstract] | |
Outstanding Warrants to Purchase Shares of Common Stock | At December 31, 2015, outstanding warrants to purchase shares of common stock are as follows: Shares Underlying Outstanding Warrants Exercise Price Expiration Date 2,046,139 $ 2.75 January 2016 10,625,000 $ 1.10 November 2016 28,097,400 $ 0.65 June 2018 13,081,428 $ 0.01 November 2019 22,011,265 $ 0.75 November 2019 1,524,390 $ 0.41 August 2020 77,385,622 |
Equity Incentive Plans (Tables)
Equity Incentive Plans (Tables) | 12 Months Ended |
Dec. 31, 2015 | |
Disclosure Of Compensation Related Costs Sharebased Payments [Abstract] | |
Share-Based Compensation Expense from All Stock Options Granted Charged to Consolidated Statements of Operations | The share-based compensation expense from all stock options granted that has been charged to our consolidated statements of operations and comprehensive loss in those periods was as follows (in thousands): Years ended December 31, 2015 2014 Selling, general and administrative expense $ 2,077 $ 1,607 Research and development expense 598 425 Share-based compensation expense $ 2,675 $ 2,032 |
Summary of Option Activity | The following table summarizes our stock option activity for the year ended December 31, 2015: Shares Underlying Option Awards Weighted-Average Exercise Price Weighted-Average Remaining Contractual Years Aggregate Intrinsic Value (in thousands) Outstanding at January 1, 2015 13,616,137 $ 1.00 Granted 13,114,372 $ 0.55 Exercised - $ — Expired/cancelled/forfeited (3,827,782 ) $ 0.65 Outstanding at December 31, 2015 22,902,727 $ 0.80 7.46 $ 4 Options exercisable at December 31, 2015 10,428,421 $ 1.10 5.72 $ - Vested and expected to vest at December 31, 2015 21,897,047 $ 0.81 7.38 $ 3 |
Black-Scholes Option-Valuation Model and the Calculation of Share-based Compensation for Option Grants to Employees and Non-Employee Directors | The assumptions used in the Black-Scholes option-valuation model and the calculation of share-based compensation for option grants to employees and non-employee directors during the years ended December 31, 2015 and 2014 are as follows: Years ended December 31, 2015 2014 Risk-free interest rate 1.6 - 1.9% 1.9 - 2.1% Dividend yield 0.0% 0.0% Expected volatility 78 - 99% 104 - 112% Expected term (in years) 5.3 - 6.2 years 5.4 - 6.2 years Forfeiture rate 7 % 9% |
Commitments (Tables)
Commitments (Tables) | 12 Months Ended |
Dec. 31, 2015 | |
Commitments And Contingencies Disclosure [Abstract] | |
Future Rental Commitments | Future rental commitments under all operating leases are as follows (in thousands): Year Ending December 31, 2016 $ 389 2017 489 2018 547 2019 557 2020 237 Thereafter - Total $ 2,219 |
Income Taxes (Tables)
Income Taxes (Tables) | 12 Months Ended |
Dec. 31, 2015 | |
Income Tax Disclosure [Abstract] | |
Income Tax Provision/(Benefit) | The income tax benefit is different from that which would be obtained by applying the statutory Federal income tax rate of 34% to income before income tax expense. The items causing this difference for the years ended December 31, 2015 and 2014 are as follows: Years ended December 31, 2015 2014 (in thousands) Income tax benefit at federal statutory rate $ (13,546 ) $ (9,758 ) Orphan drug credit / R&D credit (7,530 ) (4,575 ) Stock options 594 278 Other 187 (213 ) Change in federal valuation allowance 20,295 14,268 Total $ - $ - |
Significant Components of Deferred Tax Assets and Liabilities | Significant components of deferred tax assets and liabilities at December 31, 2015 and 2014 are as follows: Years ended December 31, 2015 2014 (in thousands) Deferred tax assets: Accrued expenses $ 619 $ 592 Stock options under ASC 718 2,610 2,240 Net operating loss carry forwards 31,649 20,583 Income tax credit carry forwards 19,369 8,109 Property and equipment 20 12 Intangibles 895 1,793 Other 69 33 Total deferred tax assets 55,231 33,362 Less: valuation allowance (55,231 ) (33,362 ) Total deferred tax assets, net of valuation allowance $ - $ - Deferred tax liabilities: Acquired intangibles (3,404 ) (3,404 ) Total deferred tax assets/liabilities, net of valuation allowance $ (3,404 ) $ (3,404 ) |
Summary of Quarterly Financia38
Summary of Quarterly Financial Data (unaudited) (Tables) | 12 Months Ended |
Dec. 31, 2015 | |
Quarterly Financial Information Disclosure [Abstract] | |
Quarterly Statements of Operations Data | The following is a summary of the unaudited quarterly results of operations for the years ended December 31, 2015 and 2014 (in thousands, except per share data): Quarterly statements of operations data Quarters Ended 2015 (unaudited) March 31 June 30 September 30 December 31 Revenue $ - $ - $ - $ - Loss from operations (9,650 ) (10,181 ) (9,828 ) (9,714 ) Net loss (9,616 ) (10,151 ) (9,912 ) (10,162 ) Net loss applicable to common stock (9,616 ) (10,151 ) (9,912 ) (10,162 ) Basic and diluted net loss per share $ (0.06 ) $ (0.06 ) $ (0.06 ) $ (0.06 ) Basic and diluted weighted average number of shares of common stock outstanding 159,459 162,128 163,614 163,614 Quarters Ended 2014 (unaudited) March 31 June 30 September 30 December 31 Revenue $ - $ - $ - $ - Loss from operations (6,839 ) (7,202 ) (7,884 ) (7,354 ) Net loss (6,371 ) (7,152 ) (7,866 ) (7,313 ) Net loss applicable to common stock (6,371 ) (7,152 ) (7,866 ) (7,313 ) Basic and diluted net loss per share $ (0.06 ) $ (0.06 ) $ (0.06 ) $ (0.05 ) Basic and diluted weighted average number of shares of common stock outstanding 105,054 115,587 123,287 145,257 |
Description of Business - Addit
Description of Business - Additional Information (Detail) - USD ($) $ in Thousands | 3 Months Ended | 12 Months Ended | |||||||||
Dec. 31, 2015 | Sep. 30, 2015 | Jun. 30, 2015 | Mar. 31, 2015 | Dec. 31, 2014 | Sep. 30, 2014 | Jun. 30, 2014 | Mar. 31, 2014 | Dec. 31, 2015 | Dec. 31, 2014 | Jul. 31, 2016 | |
Description Of Business [Line Items] | |||||||||||
Loss from operations | $ (9,714) | $ (9,828) | $ (10,181) | $ (9,650) | $ (7,354) | $ (7,884) | $ (7,202) | $ (6,839) | $ (39,373) | $ (29,279) | |
Net cash used in operating activities | (32,949) | (24,645) | |||||||||
Accumulated deficit | (274,973) | $ (235,131) | (274,973) | $ (235,131) | |||||||
Cash, Cash Equivalents, and Investment Securities | 41,000 | 41,000 | |||||||||
Working capital | $ 19,100 | $ 19,100 | |||||||||
Loan and Security Agreement [Member] | Hercules [Member] | |||||||||||
Description Of Business [Line Items] | |||||||||||
Prepayment date of outstanding principal | Jul. 31, 2016 | ||||||||||
Loan and Security Agreement [Member] | Hercules [Member] | Scenario, Forecast [Member] | |||||||||||
Description Of Business [Line Items] | |||||||||||
Prepayments of outstanding principal | $ 10,000 |
Summary of Significant Accoun40
Summary of Significant Accounting Policies - Additional Information (Detail) - USD ($) | Sep. 30, 2015 | Dec. 31, 2015 | Dec. 31, 2014 |
Summary Of Significant Accounting Policies [Line Items] | |||
Cash equivalents carried at cost | $ 15,800,000 | $ 16,600,000 | |
Cash and cash equivalents of highly liquid investments with maturity date of purchase | three months or less | ||
Amount of Investment Securities | $ 2,700,000 | ||
Percentage of investment securities | 15.00% | ||
Determination percentage | 50.00% | ||
Impairment of goodwill | $ 0 | ||
In-process research and development | $ 0 | ||
Uncertain income tax position | 50.00% | ||
Minimum [Member] | |||
Summary Of Significant Accounting Policies [Line Items] | |||
Maturity period | 1 year | ||
Estimated useful lives of assets | 3 years | ||
Maximum [Member] | |||
Summary Of Significant Accounting Policies [Line Items] | |||
Maturity period | 18 months | ||
Estimated useful lives of assets | 5 years |
Summary of Significant Accoun41
Summary of Significant Accounting Policies - Weighted-average Number of Those Common Stock Equivalents Outstanding (Detail) - shares | 12 Months Ended | |
Dec. 31, 2015 | Dec. 31, 2014 | |
Warrants [Member] | ||
Antidilutive Securities Excluded From Computation Of Earnings Per Share [Line Items] | ||
Anti-dilutive securities | 77,355,271 | 49,217,355 |
Options [Member] | ||
Antidilutive Securities Excluded From Computation Of Earnings Per Share [Line Items] | ||
Anti-dilutive securities | 21,514,699 | 11,760,113 |
Summary of Significant Accoun42
Summary of Significant Accounting Policies - Supplemental Cash Flow Information (Detail) - USD ($) shares in Thousands, $ in Thousands | 12 Months Ended | |
Dec. 31, 2015 | Dec. 31, 2014 | |
Accounting Policies [Abstract] | ||
Cash paid for interest on debt facility | $ 298 | |
Supplemental disclosures of non-cash investing and financing activities: | ||
Issuance of common stock for acquisitions | $ 3,270 | |
Assumptions of liabilities in acquisitions | 1,069 | |
Unrealized loss on investment securities | $ (8) | (4) |
Warrants issued in connection with debt facility | 392 | |
Purchase of equipment under capital lease | $ 40 | |
Purchases of property and equipment in accounts payable | $ 2 | 17 |
Offering costs included in accounts payable | $ 36 |
Acquisition of Aires - Addition
Acquisition of Aires - Additional Information (Detail) - USD ($) | Feb. 27, 2014 | Dec. 31, 2014 |
Business Acquisition, Equity Interests Issued or Issuable [Line Items] | ||
Purchase price of acquisition, based calculated number of shares and average closing prices per share | $ 3,270,000 | |
Business combination, bargain purchase gain recognized, amount | $ 486,000 | |
Deferred income tax liability resulting from the acquisition | $ 795,000 | |
Aires [Member] | ||
Business Acquisition, Equity Interests Issued or Issuable [Line Items] | ||
Additional Common stock shares issued | 1,049,706 | |
Agreement holdback period | 6 months | |
Additional aggregate unregistered shares of common stock | 4,053,996 | |
Total merger consideration | 5,103,702 | |
Milestone payments | $ 0 | |
Earn-out payments | 0 | |
Purchase price of acquisition, based calculated number of shares and average closing prices per share | $ 3,300,000 | |
Average closing price | $ 0.80 | |
Business combination, bargain purchase gain recognized, amount | $ 500,000 | |
IPR&D, AIR-001 program, fair value | 2,000,000 | |
Deferred income tax liability resulting from the acquisition | $ 800,000 |
Acquisition of Aires - Summary
Acquisition of Aires - Summary of Preliminary Estimated Fair Values of Net Tangible and Intangible Assets and Liabilities (Detail) $ in Thousands | Feb. 27, 2014USD ($) |
Business Combinations [Abstract] | |
Cash and cash equivalents | $ 3,534 |
Prepaid expenses and other assets | 86 |
In-process research and development | 2,000 |
Total assets: | 5,620 |
Accounts payable and accrued liabilities | 1,069 |
Deferred tax liability | 795 |
Total liabilities: | 1,864 |
Net assets acquired | $ 3,756 |
Goodwill and IPR&D - Summary of
Goodwill and IPR&D - Summary of Goodwill and IPR&D (Detail) - USD ($) $ in Thousands | Dec. 31, 2015 | Dec. 31, 2014 | Feb. 27, 2014 |
Goodwill And Intangible Assets [Line Items] | |||
Goodwill | $ 3,007 | $ 3,007 | |
In-process research and development | $ 2,000 | ||
Total goodwill and IPR&D | 11,556 | ||
SynthRx [Member] | |||
Goodwill And Intangible Assets [Line Items] | |||
In-process research and development | 6,549 | ||
Aires [Member] | |||
Goodwill And Intangible Assets [Line Items] | |||
In-process research and development | $ 2,000 |
Goodwill and IPR&D - Additional
Goodwill and IPR&D - Additional Information (Detail) | Sep. 30, 2015USD ($) |
SynthRx [Member] | |
Goodwill And Intangible Assets [Line Items] | |
Impairment charge | $ 0 |
Investment Securities - Investm
Investment Securities - Investment Securities (Detail) - USD ($) $ in Thousands | 12 Months Ended | |
Dec. 31, 2015 | Dec. 31, 2014 | |
Investment Holdings [Abstract] | ||
Investment securities | $ 17,929 | $ 21,481 |
Cost basis of investment securities | 17,946 | 21,506 |
Net unrealized losses on investment securities | $ 17 | $ 25 |
Fair Value of Financial Instr48
Fair Value of Financial Instruments - Fair Values of Cash Equivalents and Investment Securities (Detail) - USD ($) $ in Thousands | Dec. 31, 2015 | Dec. 31, 2014 |
Fair Value Assets And Liabilities Measured On Recurring And Nonrecurring Basis [Line Items] | ||
Investment securities | $ 17,929 | $ 21,481 |
Fair Value, Measurements, Nonrecurring [Member] | ||
Fair Value Assets And Liabilities Measured On Recurring And Nonrecurring Basis [Line Items] | ||
Cash equivalents | 15,799 | 16,626 |
Investment securities | 17,929 | 21,481 |
Fair Value Determined Under Level 1 [Member] | Fair Value, Measurements, Nonrecurring [Member] | ||
Fair Value Assets And Liabilities Measured On Recurring And Nonrecurring Basis [Line Items] | ||
Cash equivalents | 15,799 | 16,626 |
Fair Value Determined Under Level 2 [Member] | Fair Value, Measurements, Nonrecurring [Member] | ||
Fair Value Assets And Liabilities Measured On Recurring And Nonrecurring Basis [Line Items] | ||
Investment securities | $ 17,929 | $ 21,481 |
Property and Equipment - Proper
Property and Equipment - Property and Equipment (Detail) - USD ($) $ in Thousands | 12 Months Ended | |
Dec. 31, 2015 | Dec. 31, 2014 | |
Property, Plant and Equipment [Line Items] | ||
Property and equipment, gross | $ 565 | $ 532 |
Less: accumulated depreciation and amortization | (339) | (344) |
Property and equipment, net | $ 226 | 188 |
Minimum [Member] | ||
Property, Plant and Equipment [Line Items] | ||
Useful Lives | 3 years | |
Maximum [Member] | ||
Property, Plant and Equipment [Line Items] | ||
Useful Lives | 5 years | |
Office Furniture, Computer and Lab Equipment [Member] | ||
Property, Plant and Equipment [Line Items] | ||
Property and equipment, gross | $ 493 | 416 |
Office Furniture, Computer and Lab Equipment [Member] | Minimum [Member] | ||
Property, Plant and Equipment [Line Items] | ||
Useful Lives | 3 years | |
Office Furniture, Computer and Lab Equipment [Member] | Maximum [Member] | ||
Property, Plant and Equipment [Line Items] | ||
Useful Lives | 5 years | |
Computer Software [Member] | ||
Property, Plant and Equipment [Line Items] | ||
Useful Lives | 3 years | |
Property and equipment, gross | $ 16 | 58 |
Leasehold Improvements [Member] | ||
Property, Plant and Equipment [Line Items] | ||
Useful Lives | 1 year | |
Property and equipment, gross | $ 44 | 35 |
Equipment in progress [Member] | ||
Property, Plant and Equipment [Line Items] | ||
Useful Lives | 0 years | |
Property and equipment, gross | $ 12 | $ 23 |
Property and Equipment - Additi
Property and Equipment - Additional Information (Detail) - USD ($) | 12 Months Ended | |
Dec. 31, 2015 | Dec. 31, 2014 | |
Property, Plant and Equipment [Line Items] | ||
Depreciation and amortization expense | $ 146,000 | $ 85,000 |
Lease obligations | 40,000 | |
Imputed interest on capital lease | $ 8,000 | |
Minimum [Member] | ||
Property, Plant and Equipment [Line Items] | ||
Useful Lives | 3 years | |
Minimum [Member] | Capital Lease [Member] | ||
Property, Plant and Equipment [Line Items] | ||
Useful Lives | 3 years | |
Rate of interest on capital lease | 8.00% | |
Maximum [Member] | ||
Property, Plant and Equipment [Line Items] | ||
Useful Lives | 5 years | |
Maximum [Member] | Capital Lease [Member] | ||
Property, Plant and Equipment [Line Items] | ||
Useful Lives | 5 years | |
Rate of interest on capital lease | 14.00% |
Property and Equipment - Future
Property and Equipment - Future Commitments Under Capital Leases (Detail) $ in Thousands | Dec. 31, 2015USD ($) |
Capital Leases Future Minimum Payments Due [Abstract] | |
2,016 | $ 11 |
2,017 | 10 |
2,018 | 10 |
2,019 | 8 |
Total | $ 39 |
Accrued Liabilities - Accrued L
Accrued Liabilities - Accrued Liabilities (Detail) - USD ($) $ in Thousands | Dec. 31, 2015 | Dec. 31, 2014 |
Payables And Accruals [Abstract] | ||
Accrued R&D agreements and study expenses | $ 7,898 | $ 5,383 |
Other accrued liabilities | 254 | 242 |
Total accrued liabilities | $ 8,152 | $ 5,625 |
Debt Facility - Additional Info
Debt Facility - Additional Information (Detail) - USD ($) | Aug. 11, 2015 | Jul. 31, 2016 | Dec. 31, 2015 | Feb. 29, 2016 | Feb. 25, 2016 | Sep. 28, 2015 | Nov. 30, 2014 |
Line Of Credit Facility [Line Items] | |||||||
Interest rate terms of each tranche | The interest rate for the principal balance under the Loan Agreement is the greater of (i) 8.95% plus the prime rate as reported in The Wall Street Journal minus 3.25%, and (ii) 8.95%, determined on a daily basis. | ||||||
Interest rate for each tranche | 8.95% | ||||||
Interest rate decreases if prime rate is used | (3.25%) | ||||||
Interest rate at end of period | 9.20% | ||||||
Final payment due on date of maturity | $ 712,500 | ||||||
Loan agreement payment terms | The interest rate for the principal balance under the Loan Agreement is the greater of (i) 8.95% plus the prime rate as reported in The Wall Street Journal minus 3.25%, and (ii) 8.95%, determined on a daily basis. The interest rate as of December 31, 2015 was 9.20%. Monthly payments under the amended Loan Agreement are interest only until July 1, 2016, followed by equal monthly payments of principal and interest through the scheduled maturity date of January 1, 2019. | ||||||
Warrants issued to purchase shares of common stock | 77,385,622 | 22,011,265 | |||||
Exercise price of warrants per share | $ 0.75 | ||||||
Subsequent Event [Member] | |||||||
Line Of Credit Facility [Line Items] | |||||||
Exercise price of warrants per share | $ 0.42 | ||||||
Warrants to Hercules [Member] | |||||||
Line Of Credit Facility [Line Items] | |||||||
Warrants issued to purchase shares of common stock | 1,524,390 | ||||||
Exercise price of warrants per share | $ 0.41 | ||||||
Warrants, expected term | 5 years | ||||||
Warrants, expected volatility rate | 77.00% | ||||||
Warrants, risk free interest rate | 1.50% | ||||||
Warrants, expected dividend yield | 0.00% | ||||||
Amortization of debt discount | $ 400,000 | ||||||
Warrants to Hercules [Member] | Subsequent Event [Member] | Second Amendment | |||||||
Line Of Credit Facility [Line Items] | |||||||
Warrants issued to purchase shares of common stock | 2,272,727 | ||||||
Exercise price of warrants per share | $ 0.275 | ||||||
Scenario, Forecast [Member] | |||||||
Line Of Credit Facility [Line Items] | |||||||
Payment against the principal balance | $ 430,000 | ||||||
Prime Rate [Member] | |||||||
Line Of Credit Facility [Line Items] | |||||||
Interest rate spread for each tranche | 8.95% | ||||||
Loan and Security Agreement [Member] | Hercules [Member] | |||||||
Line Of Credit Facility [Line Items] | |||||||
Secured loan amount | $ 15,000,000 | ||||||
Debt prepayment charges, option one | 1.00% | ||||||
Debt prepayment charges, option two | 2.00% | ||||||
Debt prepayment charges, option three | 3.00% | ||||||
Payments of debt issuance costs | $ 112,500 | ||||||
Commitment fee | 25,000 | ||||||
Loan and Security Agreement [Member] | Hercules [Member] | First Advance [Member] | |||||||
Line Of Credit Facility [Line Items] | |||||||
Loan borrowed amount | $ 5,000,000 | ||||||
Loan and Security Agreement [Member] | Hercules [Member] | Second Advance [Member] | |||||||
Line Of Credit Facility [Line Items] | |||||||
Line of credit facility, remaining borrowing capacity | $ 10,000,000 |
Debt Facility - Summary of Comp
Debt Facility - Summary of Components of Debt Facility Carrying Value (Detail) $ in Thousands | Dec. 31, 2015USD ($) |
Line Of Credit Facility [Line Items] | |
Short-Term, Carrying value | $ 10,991 |
Long-Term, Carrying value | 3,726 |
Short-term [Member] | |
Line Of Credit Facility [Line Items] | |
Potential prepayment to lender | 10,000 |
Principal payments to lender and end of term charge | 874 |
Accrued interest | 117 |
Long-term [Member] | |
Line Of Credit Facility [Line Items] | |
Principal payments to lender and end of term charge | 4,839 |
Debt issuance costs | (776) |
Debt discount related to warrants | $ (337) |
Capital Stock and Warrants - Ad
Capital Stock and Warrants - Additional Information (Detail) - USD ($) | 1 Months Ended | 12 Months Ended | 23 Months Ended | |||||
Feb. 29, 2016 | Aug. 31, 2015 | Nov. 30, 2014 | Feb. 28, 2014 | Dec. 31, 2015 | Dec. 31, 2014 | Dec. 31, 2015 | Feb. 25, 2016 | |
Class of Warrant or Right [Line Items] | ||||||||
Common stock, shares authorized | 500,000,000 | 500,000,000 | 500,000,000 | |||||
Common stock, par value | $ 0.001 | $ 0.001 | $ 0.001 | |||||
Preferred stock, authorized | 1,000,000 | 1,000,000 | ||||||
Preferred stock, par value | $ 0.001 | $ 0.001 | ||||||
Common stock, shares outstanding | 163,614,297 | 159,458,376 | 163,614,297 | |||||
Preferred stock, shares outstanding | 0 | 0 | ||||||
Common stock, shares issued | 30,941,102 | 24,859,107 | ||||||
Weighted average sale price | $ 0.70 | |||||||
Gross proceeds of financing | $ 21,000,000 | $ 17,500,000 | ||||||
Net proceeds from financing | $ 19,700,000 | $ 16,600,000 | ||||||
Warrants issued to purchase shares of common stock | 22,011,265 | 77,385,622 | 77,385,622 | |||||
Exercise price of warrants per share | $ 0.75 | |||||||
Warrants exercisable period | Nov. 12, 2019 | |||||||
Additional shares of common available for outstanding exercisable prefunded warrants | 13,081,428 | |||||||
Securities offered and sold combination | These securities were offered and sold to the underwriters and the public in units with each Series A unit consisting of one share of our common stock and one-half (0.5) of a warrant and each Series B unit consisting of one pre-funded warrant and one-half (0.5) of a warrant. | |||||||
Proceeds from exercise of warrants | $ 16,500,000 | $ 6,148,000 | ||||||
Pre-funded Warrants [Member] | ||||||||
Class of Warrant or Right [Line Items] | ||||||||
Exercise price of warrants per share | $ 0.01 | |||||||
Proceeds from exercise of warrants | $ 100,000 | |||||||
Series A [Member] | ||||||||
Class of Warrant or Right [Line Items] | ||||||||
Common stock, shares issued | 30,941,102 | |||||||
Number of common stock called by each warrant | 0.5 | |||||||
Series A [Member] | Common Stock [Member] | ||||||||
Class of Warrant or Right [Line Items] | ||||||||
Number of securities in each unit issued | 1 | |||||||
Series B [Member] | ||||||||
Class of Warrant or Right [Line Items] | ||||||||
Additional shares of common available for outstanding exercisable prefunded warrants | 13,081,428 | |||||||
Number of common stock called by each warrant | 0.5 | |||||||
Series B [Member] | Pre-funded Warrants [Member] | ||||||||
Class of Warrant or Right [Line Items] | ||||||||
Number of securities in each unit issued | 1 | |||||||
Warrants to Hercules [Member] | ||||||||
Class of Warrant or Right [Line Items] | ||||||||
Warrants issued to purchase shares of common stock | 1,524,390 | 1,524,390 | ||||||
Exercise price of warrants per share | $ 0.41 | $ 0.41 | ||||||
Warrants exercisable period | Aug. 11, 2020 | |||||||
Subsequent Event [Member] | ||||||||
Class of Warrant or Right [Line Items] | ||||||||
Common stock, shares issued | 29,090,910 | |||||||
Gross proceeds of financing | $ 8,000,000 | |||||||
Net proceeds from financing | $ 7,300,000 | |||||||
Exercise price of warrants per share | $ 0.42 | |||||||
Warrants exercisable period | Aug. 17, 2016 | |||||||
Securities offered and sold combination | each consisting of one share of our common stock and one warrant to purchase one share of our common stock. | |||||||
Number of securities in each unit issued | 1 | |||||||
Number of common stock called by each warrant | 1 | |||||||
Subsequent Event [Member] | Second Amendment | Warrants to Hercules [Member] | ||||||||
Class of Warrant or Right [Line Items] | ||||||||
Warrants issued to purchase shares of common stock | 2,272,727 | |||||||
Exercise price of warrants per share | $ 0.275 | |||||||
Maximum [Member] | ||||||||
Class of Warrant or Right [Line Items] | ||||||||
Amount available to sell under equity program | $ 30,000,000 | $ 30,000,000 |
Capital Stock and Warrants - Ou
Capital Stock and Warrants - Outstanding Warrants to Purchase Shares of Common Stock (Detail) - $ / shares | 12 Months Ended | |
Dec. 31, 2015 | Nov. 30, 2014 | |
Class of Warrant or Right [Line Items] | ||
Shares Underlying Outstanding Warrants | 77,385,622 | 22,011,265 |
Exercise Price | $ 0.75 | |
Exercise Price One [Member] | ||
Class of Warrant or Right [Line Items] | ||
Shares Underlying Outstanding Warrants | 2,046,139 | |
Exercise Price | $ 2.75 | |
Expiration Date | 2016-01 | |
Exercise Price Two [Member] | ||
Class of Warrant or Right [Line Items] | ||
Shares Underlying Outstanding Warrants | 10,625,000 | |
Exercise Price | $ 1.10 | |
Expiration Date | 2016-11 | |
Exercise Price Three [Member] | ||
Class of Warrant or Right [Line Items] | ||
Shares Underlying Outstanding Warrants | 28,097,400 | |
Exercise Price | $ 0.65 | |
Expiration Date | 2018-06 | |
Exercise Price Four [Member] | ||
Class of Warrant or Right [Line Items] | ||
Shares Underlying Outstanding Warrants | 13,081,428 | |
Exercise Price | $ 0.01 | |
Expiration Date | 2019-11 | |
Exercise Price Five [Member] | ||
Class of Warrant or Right [Line Items] | ||
Shares Underlying Outstanding Warrants | 22,011,265 | |
Exercise Price | $ 0.75 | |
Expiration Date | 2019-11 | |
Exercise Price Six [Member] | ||
Class of Warrant or Right [Line Items] | ||
Shares Underlying Outstanding Warrants | 1,524,390 | |
Exercise Price | $ 0.41 | |
Expiration Date | 2020-08 |
Equity Incentive Plans - Additi
Equity Incentive Plans - Additional Information (Detail) - USD ($) $ / shares in Units, $ in Millions | 12 Months Ended | |
Dec. 31, 2015 | Dec. 31, 2014 | |
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||
Common stock available for grant | 21,583,541 | |
Purchase price of shares of common stock | Less than 100% | |
Contractual term | 10 years | |
Vesting period | 4 years | |
Weighted-average grant date fair value | $ 0.42 | $ 0.50 |
Unamortized compensation cost | $ 4.6 | |
Expected to be recognized over a weighted-average period | 2 years 9 months 18 days | |
Stock Option [Member] | ||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||
Stock appreciation right | 1 | |
Other Than Stock Option [Member] | ||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||
Stock appreciation right | 1.34 | |
President and Chief Operating Officer [Member] | ||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||
Additional share based compensation expense | $ 0.4 | |
Reduction in share based compensation expense, unvested stock cancellation | 0.1 | |
President and Chief Operating Officer [Member] | Selling, General and Administrative Expense [Member] | ||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||
Share-based compensation expense | $ 0.3 | |
Original 2008 Plan [Member] | ||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||
Awards granted | 0 | |
Amended and Restated 2008 Plan [Member] | ||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||
Awards granted | 0 |
Equity Incentive Plans - Share-
Equity Incentive Plans - Share-Based Compensation Expense from All Stock Options Granted Charged to Consolidated Statements of Operations (Detail) - USD ($) $ in Thousands | 12 Months Ended | |
Dec. 31, 2015 | Dec. 31, 2014 | |
Employee Service Share-based Compensation, Allocation of Recognized Period Costs [Line Items] | ||
Share-based compensation expense | $ 2,675 | $ 2,032 |
Selling, General and Administrative Expense [Member] | ||
Employee Service Share-based Compensation, Allocation of Recognized Period Costs [Line Items] | ||
Share-based compensation expense | 2,077 | 1,607 |
Research and Development Expense [Member] | ||
Employee Service Share-based Compensation, Allocation of Recognized Period Costs [Line Items] | ||
Share-based compensation expense | $ 598 | $ 425 |
Equity Incentive Plans - Summar
Equity Incentive Plans - Summary of Option Activity (Detail) $ / shares in Units, $ in Thousands | 12 Months Ended |
Dec. 31, 2015USD ($)$ / sharesshares | |
Disclosure Of Compensation Related Costs Sharebased Payments [Abstract] | |
Shares Underlying Options, Outstanding at beginning balance | shares | 13,616,137 |
Shares Underlying Options, Granted | shares | 13,114,372 |
Shares Underlying Options, Expired/cancelled/forfeited | shares | (3,827,782) |
Shares Underlying Options, Outstanding at ending balance | shares | 22,902,727 |
Shares Underlying Options, Options exercisable | shares | 10,428,421 |
Shares Underlying Options, Vested and expected to vest | shares | 21,897,047 |
Weighted-Average Exercise Price, beginning balance | $ / shares | $ 1 |
Weighted-Average Exercise Price, Granted | $ / shares | 0.55 |
Weighted-Average Exercise Price, Expired/cancelled/forfeited | $ / shares | 0.65 |
Weighted-Average Exercise Price, ending balance | $ / shares | 0.80 |
Weighted-Average Exercise Price, Options exercisable | $ / shares | 1.10 |
Weighted-Average Exercise Price, Vested and expected to vest | $ / shares | $ 0.81 |
Weighted-Average Remaining Contractual Years | 7 years 5 months 16 days |
Weighted-Average Remaining Contractual Years, Option exercisable | 5 years 8 months 19 days |
Weighted-Average Remaining Contractual Years, Vested and expected to vest | 7 years 4 months 17 days |
Aggregate Intrinsic Value, ending balance | $ | $ 4 |
Aggregate Intrinsic Value, Vested and expected to vest | $ | $ 3 |
Equity Incentive Plans - Black-
Equity Incentive Plans - Black-Scholes Option-Valuation Model for Option Grants to Employees and Non-Employee Directors (Detail) | 12 Months Ended | |
Dec. 31, 2015 | Dec. 31, 2014 | |
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||
Risk-free interest rate, Minimum | 1.60% | 1.90% |
Risk-free interest rate, Maximum | 1.90% | 2.10% |
Dividend yield | 0.00% | 0.00% |
Expected volatility, Maximum | 99.00% | 112.00% |
Expected volatility, Minimum | 78.00% | 104.00% |
Forfeiture rate | 7.00% | 9.00% |
Minimum [Member] | ||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||
Expected term (in years) | 5 years 3 months 18 days | 5 years 4 months 24 days |
Maximum [Member] | ||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||
Expected term (in years) | 6 years 2 months 12 days | 6 years 2 months 12 days |
Commitments - Additional Inform
Commitments - Additional Information (Detail) | 1 Months Ended | 12 Months Ended | ||
Jul. 31, 2014USD ($) | Dec. 31, 2015USD ($)ft² | Dec. 31, 2014USD ($) | Apr. 30, 2011shares | |
Commitments And Contingencies [Line Items] | ||||
Lease office space | ft² | 13,700 | |||
Lease commencement date | Jan. 20, 2015 | |||
Lease expiration date | May 31, 2020 | |||
Monthly rent | $ 41,000 | |||
Percentage of lease escalated | 3.00% | |||
Lease payment abated | $ 96,000 | |||
Lease payment | $ 300,000 | |||
Security deposit | 130,000 | |||
Office equipment lease expiration | 2,019 | |||
Rent expense | $ 508,000 | $ 334,000 | ||
Prepayment, Months 13, 16, 19, 24 Of The Lease [Member] | ||||
Commitments And Contingencies [Line Items] | ||||
Monthly rent | $ 170,000 | |||
First Milestone - FDA Acceptance [Member] | ||||
Commitments And Contingencies [Line Items] | ||||
Common stock shares to be issued upon achieving milestones | shares | 3,839,400 | |||
Second Milestone - FDA Approval [Member] | ||||
Commitments And Contingencies [Line Items] | ||||
Common stock shares to be issued upon achieving milestones | shares | 8,638,650 | |||
SynthRx [Member] | ||||
Commitments And Contingencies [Line Items] | ||||
Common stock shares to be issued upon achieving milestones | shares | 12,478,050 |
Commitments - Future Rental Com
Commitments - Future Rental Commitments (Detail) $ in Thousands | Dec. 31, 2015USD ($) |
Commitments And Contingencies Disclosure [Abstract] | |
2,016 | $ 389 |
2,017 | 489 |
2,018 | 547 |
2,019 | 557 |
2,020 | 237 |
Total | $ 2,219 |
Income Taxes - Additional Infor
Income Taxes - Additional Information (Detail) - USD ($) | 12 Months Ended | |
Dec. 31, 2015 | Dec. 31, 2014 | |
Operating Loss Carryforwards [Line Items] | ||
Provision or benefit for income taxes | $ 0 | $ 0 |
Statutory Federal income tax rate | 34.00% | 34.00% |
Cumulative change in ownership percentage description | more than 50% | |
Income tax holiday, testing period | 3 years | |
Cumulative change in ownership percentage | 50.00% | |
Impact on income tax, tax attribute carry forwards | $ 0 | |
Operating loss expiration year | 2,031 | |
R&D/orphan drug tax credit carry forwards | $ 19,369,000 | $ 8,109,000 |
Uncertain income tax position | 50.00% | |
Unrecognized tax benefits | $ 0 | |
Period of change in unrecognized tax benefits | 12 months | |
Tax liability, penalties or interest | $ 0 | $ 0 |
Federal [Member] | ||
Operating Loss Carryforwards [Line Items] | ||
Tax loss carry forwards | 80,300,000 | |
R&D/orphan drug tax credit carry forwards | $ 18,800,000 | |
Aforementioned tax credit expiration beginning year | 2,031 | |
State and Local Jurisdiction [Member] | CALIFORNIA | ||
Operating Loss Carryforwards [Line Items] | ||
Tax loss carry forwards | $ 74,400,000 | |
R&D/orphan drug tax credit carry forwards | $ 900,000 |
Income Taxes - Income Tax Provi
Income Taxes - Income Tax Provision/(Benefit) (Detail) - USD ($) | 12 Months Ended | |
Dec. 31, 2015 | Dec. 31, 2014 | |
Income Tax Disclosure [Abstract] | ||
Income tax benefit at federal statutory rate | $ (13,546,000) | $ (9,758,000) |
Orphan drug credit / R&D credit | (7,530,000) | (4,575,000) |
Stock options | 594,000 | 278,000 |
Other | 187,000 | (213,000) |
Change in federal valuation allowance | 20,295,000 | 14,268,000 |
Total | $ 0 | $ 0 |
Income Taxes - Significant Comp
Income Taxes - Significant Components of Deferred Tax Assets and Liabilities (Detail) - USD ($) $ in Thousands | Dec. 31, 2015 | Dec. 31, 2014 |
Deferred tax assets: | ||
Accrued expenses | $ 619 | $ 592 |
Stock options under ASC 718 | 2,610 | 2,240 |
Net operating loss carry forwards | 31,649 | 20,583 |
Income tax credit carry forwards | 19,369 | 8,109 |
Property and equipment | 20 | 12 |
Intangibles | 895 | 1,793 |
Other | 69 | 33 |
Total deferred tax assets | 55,231 | 33,362 |
Less: valuation allowance | (55,231) | (33,362) |
Deferred tax liabilities: | ||
Acquired intangibles | (3,404) | (3,404) |
Total deferred tax assets/liabilities, net of valuation allowance | $ (3,404) | $ (3,404) |
401(k) Plan - Additional Inform
401(k) Plan - Additional Information (Detail) - USD ($) | 12 Months Ended | |
Dec. 31, 2015 | Dec. 31, 2014 | |
Compensation And Retirement Disclosure [Abstract] | ||
Voluntary contributions by employees | 100.00% | |
Matching contributions | 100.00% | |
Employee contributions | 6.00% | |
Total expense incurred in employer matching contribution | $ 246,000 | $ 212,000 |
Segment Information - Additiona
Segment Information - Additional Information (Detail) | 12 Months Ended | |
Dec. 31, 2015USD ($)Segment | Dec. 31, 2014USD ($) | |
Segment Reporting [Abstract] | ||
Recognized revenues | $ | $ 0 | $ 0 |
Number of reportable segments | Segment | 1 |
Summary of Quarterly Financia68
Summary of Quarterly Financial Data (Unaudited) - Quarterly Statements of Operations Data (Detail) - USD ($) | 3 Months Ended | 12 Months Ended | ||||||||
Dec. 31, 2015 | Sep. 30, 2015 | Jun. 30, 2015 | Mar. 31, 2015 | Dec. 31, 2014 | Sep. 30, 2014 | Jun. 30, 2014 | Mar. 31, 2014 | Dec. 31, 2015 | Dec. 31, 2014 | |
Quarterly Financial Information Disclosure [Abstract] | ||||||||||
Revenues | $ 0 | $ 0 | ||||||||
Loss from operations | $ (9,714,000) | $ (9,828,000) | $ (10,181,000) | $ (9,650,000) | $ (7,354,000) | $ (7,884,000) | $ (7,202,000) | $ (6,839,000) | (39,373,000) | (29,279,000) |
Net loss | (10,162,000) | (9,912,000) | (10,151,000) | (9,616,000) | (7,313,000) | (7,866,000) | (7,152,000) | (6,371,000) | $ (39,842,000) | $ (28,702,000) |
Net loss applicable to common stock | $ (10,162,000) | $ (9,912,000) | $ (10,151,000) | $ (9,616,000) | $ (7,313,000) | $ (7,866,000) | $ (7,152,000) | $ (6,371,000) | ||
Basic and diluted net loss per share | $ (0.06) | $ (0.06) | $ (0.06) | $ (0.06) | $ (0.05) | $ (0.06) | $ (0.06) | $ (0.06) | $ (0.25) | $ (0.23) |
Basic and diluted weighted average number of shares of common stock outstanding | 163,614,000 | 163,614,000 | 162,128,000 | 159,459,000 | 145,257,000 | 123,287,000 | 115,587,000 | 105,054,000 | 162,219,116 | 122,409,183 |
Subsequent Events - Additional
Subsequent Events - Additional Information (Detail) - USD ($) | Feb. 25, 2016 | Aug. 11, 2015 | Feb. 29, 2016 | Nov. 30, 2014 | Dec. 31, 2015 | Dec. 31, 2015 |
Subsequent Event [Line Items] | ||||||
Gross proceeds of financing | $ 21,000,000 | $ 17,500,000 | ||||
Common stock, shares issued | 30,941,102 | 24,859,107 | ||||
Securities offered and sold combination | These securities were offered and sold to the underwriters and the public in units with each Series A unit consisting of one share of our common stock and one-half (0.5) of a warrant and each Series B unit consisting of one pre-funded warrant and one-half (0.5) of a warrant. | |||||
Net proceeds from financing | $ 19,700,000 | $ 16,600,000 | ||||
Exercise price of warrants per share | $ 0.75 | |||||
Warrants exercisable period | Nov. 12, 2019 | |||||
Warrants issued to purchase shares of common stock | 22,011,265 | 77,385,622 | 77,385,622 | |||
Warrants to Hercules [Member] | ||||||
Subsequent Event [Line Items] | ||||||
Exercise price of warrants per share | $ 0.41 | $ 0.41 | ||||
Warrants exercisable period | Aug. 11, 2020 | |||||
Warrants issued to purchase shares of common stock | 1,524,390 | 1,524,390 | ||||
Loan and Security Agreement [Member] | Hercules [Member] | ||||||
Subsequent Event [Line Items] | ||||||
Payments of debt issuance costs | $ 112,500 | |||||
Subsequent Event [Member] | ||||||
Subsequent Event [Line Items] | ||||||
Gross proceeds of financing | $ 8,000,000 | |||||
Common stock, shares issued | 29,090,910 | |||||
Securities offered and sold combination | each consisting of one share of our common stock and one warrant to purchase one share of our common stock. | |||||
Number of securities in each unit issued | 1 | |||||
Number of common stock called by each warrant | 1 | |||||
Net proceeds from financing | $ 7,300,000 | |||||
Exercise price of warrants per share | $ 0.42 | |||||
Warrants exercisable period | Aug. 17, 2016 | |||||
Warrants expiration date | Feb. 16, 2021 | |||||
Subsequent Event [Member] | Second Amendment | Warrants to Hercules [Member] | ||||||
Subsequent Event [Line Items] | ||||||
Exercise price of warrants per share | $ 0.275 | |||||
Warrants issued to purchase additional shares of common stock | 748,337 | |||||
Warrants issued to purchase shares of common stock | 2,272,727 | |||||
Subsequent Event [Member] | Loan and Security Agreement [Member] | Hercules [Member] | ||||||
Subsequent Event [Line Items] | ||||||
Prepayments of outstanding principal | $ 10,000,000 | |||||
Subsequent Event [Member] | Loan and Security Agreement [Member] | Hercules [Member] | Third Amendment [Member] | ||||||
Subsequent Event [Line Items] | ||||||
Payments of debt issuance costs | $ 37,500 |