Document and Entity Information
Document and Entity Information - shares | 9 Months Ended | |
Sep. 30, 2016 | Oct. 28, 2016 | |
Document and Entity Information | ||
Entity Registrant Name | IDERA PHARMACEUTICALS, INC. | |
Trading Symbol | IDRA | |
Entity Central Index Key | 861,838 | |
Document Type | 10-Q | |
Document Period End Date | Sep. 30, 2016 | |
Amendment Flag | false | |
Current Fiscal Year End Date | --12-31 | |
Entity Current Reporting Status | Yes | |
Entity Filer Category | Accelerated Filer | |
Entity Common Stock, Shares Outstanding | 147,653,120 | |
Document Fiscal Year Focus | 2,016 | |
Document Fiscal Period Focus | Q3 |
CONDENSED BALANCE SHEETS
CONDENSED BALANCE SHEETS - USD ($) | Sep. 30, 2016 | Dec. 31, 2015 |
Current assets: | ||
Cash and cash equivalents | $ 22,154,000 | $ 26,586,000 |
Short-term investments | 29,856,000 | 33,574,000 |
Prepaid expenses and other current assets | 3,455,000 | 3,082,000 |
Total current assets | 55,465,000 | 63,242,000 |
Long-term investments | 1,408,000 | 26,997,000 |
Property and equipment, net | 1,579,000 | 1,692,000 |
Restricted cash and other assets | 26,000 | 345,000 |
Total assets | 58,478,000 | 92,276,000 |
Current liabilities: | ||
Accounts payable | 344,000 | 1,169,000 |
Accrued expenses | 6,118,000 | 4,274,000 |
Current portion of note payable | 284,000 | 261,000 |
Current portion of deferred revenue | 1,111,000 | 1,111,000 |
Total current liabilities | 7,857,000 | 6,815,000 |
Deferred revenue, net of current portion | 429,000 | 1,262,000 |
Note payable, net of current portion | 285,000 | 501,000 |
Other liabilities | 35,000 | 116,000 |
Total liabilities | 8,606,000 | 8,694,000 |
Commitments and contingencies | ||
Stockholders' equity: | ||
Common stock, $0.001 par value, Authorized - 280,000 shares; Issued and outstanding - 121,411 and 121,265 shares at September 30, 2016 and December 31, 2015, respectively | 121,000 | 121,000 |
Additional paid-in capital | 589,044,000 | 583,676,000 |
Accumulated deficit | (539,292,000) | (500,081,000) |
Accumulated other comprehensive income (loss) | (1,000) | (134,000) |
Total stockholders' equity | 49,872,000 | 83,582,000 |
Total liabilities and stockholders' equity | 58,478,000 | 92,276,000 |
Series A convertible preferred stock | ||
Stockholders' equity: | ||
Convertible preferred stock |
CONDENSED BALANCE SHEETS (Paren
CONDENSED BALANCE SHEETS (Parenthetical) - $ / shares | Sep. 30, 2016 | Dec. 31, 2015 |
Preferred stock, par value | $ 0.01 | $ 0.01 |
Preferred stock, shares authorized | 5,000,000 | 5,000,000 |
Common stock, par value | $ 0.001 | $ 0.001 |
Common stock, shares authorized | 280,000,000 | 280,000,000 |
Common stock, shares issued | 121,411,000 | 121,265,000 |
Common stock, shares outstanding | 121,411,000 | 121,265,000 |
Series A convertible preferred stock | ||
Preferred stock, shares designated | 1,500,000 | 1,500,000 |
Preferred stock, shares issued | 1,000 | 1,000 |
Preferred stock, shares outstanding | 1,000 | 1,000 |
CONDENSED STATEMENTS OF OPERATI
CONDENSED STATEMENTS OF OPERATIONS AND COMPREHENSIVE LOSS - USD ($) shares in Thousands, $ in Thousands | 3 Months Ended | 9 Months Ended | ||
Sep. 30, 2016 | Sep. 30, 2015 | Sep. 30, 2016 | Sep. 30, 2015 | |
CONDENSED STATEMENTS OF OPERATIONS AND COMPREHENSIVE LOSS | ||||
Alliance revenue | $ 323 | $ 20 | $ 918 | $ 59 |
Operating expenses: | ||||
Research and development | 9,393 | 7,454 | 28,817 | 25,134 |
General and administrative | 3,907 | 4,030 | 11,601 | 11,688 |
Total operating expenses | 13,300 | 11,484 | 40,418 | 36,822 |
Loss from operations | (12,977) | (11,464) | (39,500) | (36,763) |
Other income (expense): | ||||
Interest income | 90 | 123 | 320 | 239 |
Interest expense | (19) | (27) | (63) | (81) |
Foreign currency exchange gain (loss) | 3 | 3 | 32 | 40 |
Net loss | $ (12,903) | $ (11,365) | $ (39,211) | $ (36,565) |
Basic and diluted net loss per common share (Note 13) | $ (0.10) | $ (0.10) | $ (0.32) | $ (0.32) |
Shares used in computing basic and diluted net loss per common share | 121,389 | 118,248 | 121,332 | 113,821 |
Net loss | $ (12,903) | $ (11,365) | $ (39,211) | $ (36,565) |
Other comprehensive gain (loss): | ||||
Unrealized gain (loss) on available-for-sale securities | 13 | 50 | 133 | (10) |
Comprehensive loss | $ (12,890) | $ (11,315) | $ (39,078) | $ (36,575) |
CONDENSED STATEMENTS OF CASH FL
CONDENSED STATEMENTS OF CASH FLOWS - USD ($) | 9 Months Ended | |
Sep. 30, 2016 | Sep. 30, 2015 | |
Cash Flows from Operating Activities: | ||
Net loss | $ (39,211,000) | $ (36,565,000) |
Adjustments to reconcile net loss to net cash used in operating activities: | ||
Non-employee stock option expense | 142,000 | |
Stock-based compensation | 5,127,000 | 4,013,000 |
Issuance of common stock for services rendered | 129,000 | 90,000 |
Accretion of premiums and discounts on investments | 466,000 | 397,000 |
Depreciation and amortization expense | 484,000 | 346,000 |
Changes in operating assets and liabilities: | ||
Prepaid expenses and other current assets | (48,000) | (1,163,000) |
Accounts payable, accrued expenses, and other liabilities | 937,000 | (1,590,000) |
Deferred revenue | (833,000) | |
Net cash used in operating activities | (32,949,000) | (34,330,000) |
Cash Flows from Investing Activities: | ||
Purchases of available-for-sale securities | (2,946,000) | (63,106,000) |
Proceeds from maturity of available-for-sale securities | 29,946,000 | 23,602,000 |
Proceeds from sale of available-for-sale securities | 1,974,000 | 999,000 |
Purchases of property and equipment | (369,000) | (659,000) |
Net cash provided by (used in) investing activities | 28,605,000 | (39,164,000) |
Cash Flows from Financing Activities: | ||
Proceeds from equity financings, net of issuance costs | 80,599,000 | |
Proceeds from exercise of common stock warrants and options and employee stock purchases | 111,000 | 987,000 |
Payments on note payable | (193,000) | (59,000) |
Payments on capital lease | (6,000) | (8,000) |
Net cash (used in) provided by financing activities | (88,000) | 81,519,000 |
Net increase (decrease) in cash and cash equivalents | (4,432,000) | 8,025,000 |
Cash and cash equivalents, beginning of period | 26,586,000 | 19,971,000 |
Cash and cash equivalents, end of period | $ 22,154,000 | $ 27,996,000 |
Organization
Organization | 9 Months Ended |
Sep. 30, 2016 | |
Organization | |
Organization | (1) Organization Idera Pharmaceuticals, Inc. (“Idera” or the “Company”) is a clinical-stage biopharmaceutical company focused on the discovery, development and commercialization of novel oligonucleotide therapeutics for oncology and rare diseases. The Company uses two distinct proprietary drug discovery technology platforms to design and develop drug candidates: its Toll-like receptor (“TLR”) targeting technology and its third-generation antisense (“3GA”) technology. The Company developed these platforms based on its scientific expertise and pioneering work with synthetic oligonucleotides as therapeutic agents. Using its TLR targeting technology, the Company designs synthetic oligonucleotide-based drug candidates to modulate the activity of specific TLRs. Using its 3GA technology, the Company is developing drug candidates to turn off the messenger RNA (“mRNA”) associated with disease causing genes. The Company believes that its 3GA technology may potentially reduce the immunotoxicity and increase the potency of earlier generation antisense and RNA interference (“RNAi”) technologies. The Company’s business strategy is focused on the clinical development of drug candidates for oncology and rare diseases characterized by small, well-defined patient populations with serious unmet medical needs. The Company believes it can develop and commercialize these targeted therapies on its own. To the extent the Company seeks to develop drug candidates for broader disease indications, it plans to execute early-stage development through proof-of-concept clinical trials and explore potential collaborative alliances to support late-stage development and commercialization. The Company’s TLR-targeted clinical-stage drug candidates are IMO-2125 and IMO-8400. IMO-2125 is an agonist of TLR9 and IMO-8400 is an antagonist of TLR7, TLR8 and TLR9. The Company has also created compounds that are agonists of TLR3, TLR7, TLR8 and TLR9, as well as additional antagonist candidates. At September 30, 2016, the Company had an accumulated deficit of $539,292,000. The Company expects to incur substantial operating losses in future periods. The Company does not expect to generate significant product revenue, sales-based milestones or royalties until the Company successfully completes development and obtains marketing approval for drug candidates, either alone or in collaborations with third parties, which the Company expects will take a number of years. In order to commercialize its drug candidates, the Company needs to complete clinical development and comply with comprehensive regulatory requirements. The Company is subject to a number of risks and uncertainties similar to those of other companies of the same size within the biotechnology industry, such as uncertainty of clinical trial outcomes, uncertainty of additional funding, and history of operating losses. |
New Accounting Pronouncements -
New Accounting Pronouncements - Recently Issued | 9 Months Ended |
Sep. 30, 2016 | |
New Accounting Pronouncements - Recently Issued | |
New Accounting Pronouncements - Recently Issued | (2) New Accounting Pronouncements - Recently Issued In May 2014, the Financial Accounting Standards Board (the “FASB”) issued Accounting Standards Update (“ASU”) No. 2014-09, Revenue from Contracts with Customers (Topic 606), which was amended by ASU No. 2015-14. ASU No. 2014-09, as amended by ASU No. 2015-14, requires an entity to recognize revenue from the transfer of promised goods or services to customers in an amount that reflects the consideration to which the entity expects to be entitled in exchange for those goods or services. In particular, this ASU addresses contracts with more than one performance obligation, as well as the accounting for some costs to obtain or fulfill a contract with a customer, and provides for additional disclosures with respect to revenues and cash flows arising from contracts with customers. This ASU will be effective for fiscal years beginning after December 15, 2017, including interim periods within that fiscal year. Early adoption of this ASU is permitted only for fiscal years beginning after December 15, 2016, including interim periods within that fiscal year. The Company is currently evaluating the effect that the adoption of this ASU will have on its financial statements. In August 2014, the FASB issued ASU No. 2014-15, Disclosure of Uncertainties about an Entity’s Ability to Continue as a Going Concern. ASU 2014-15 amends FASB In January 2016, the FASB issued ASU No. 2016-01, Recognition and Measurement of Financial Assets and Financial Liabilities. The amendments in ASU 2016-01 address certain aspects of recognition, measurement, presentation and disclosure of financial instruments. ASU 2016-01 will be effective for fiscal years beginning after December 15, 2017, including interim periods within those fiscal years. Early adoption of some of the amendments included in ASU 2016-01 for financial statements of fiscal years or interim periods that have not yet been issued is permitted as of the beginning of the fiscal year of adoption. The Company is currently evaluating the effect that the adoption of ASU 2016-01 will have on its financial statements. In February 2016, the FASB issued ASU No. 2016-02, Leases. The amendments in ASU 2016-02 will require organizations that lease assets, with lease terms of more than 12 months, to recognize on the balance sheet the assets and liabilities for the rights and obligations created by those leases. Consistent with current U.S. Generally Accepted Accounting Principles (“U.S. GAAP”), the recognition, measurement, and presentation of expenses and cash flows arising from a lease by a lessee primarily will depend on its classification as a finance or operating lease. However, unlike current U.S. GAAP which requires only capital leases to be recognized on the balance sheet, ASU No. 2016-02 will require both types of leases to be recognized on the balance sheet. ASU 2016-02 will be effective for fiscal years beginning after December 15, 2018, including interim periods within those fiscal years. Early adoption is permitted. The Company is currently evaluating the effect that the adoption of ASU 2016-02 will have on its financial statements. In March 2016, the FASB issued ASU No. 2016-06, Derivatives and Hedging (Topic 815) Contingent Put and Call Options in Debt Instruments. ASU 2016-06 amends FASB ASC 815-15 to clarify what steps are required when assessing whether the economic characteristics and risks of call (put) options are clearly and closely related to the economic characteristics and risks of their debt hosts, which is one of the criteria for bifurcating an embedded derivative. ASU 2016-06 will be effective for fiscal years beginning after December 15, 2016, including interim periods within those fiscal years. An entity should apply the amendments in ASU No. 2016-06 on a modified retrospective basis to existing debt instruments as of the beginning of the fiscal year for which the amendments are effective. Early adoption is permitted, including adoption in an interim period. The Company is currently evaluating the effect that the adoption of ASU 2016-06 will have on its financial statements. In March 2016, the FASB issued ASU No. 2016-09, Compensation – Stock Compensation (Topic 718). ASU 2016-09 will require organizations to recognize all income tax effects of awards in the statement of operations when the awards vest or are settled. ASU 2016-09 will also allow organizations to repurchase more shares from employees than they could previously purchase for tax withholding purposes without triggering liability accounting and to make a policy election to account for forfeitures as they occur. ASU 2016-09 will be effective for fiscal years beginning after December 15, 2016, and interim periods within those fiscal years. Early adoption is permitted in any interim or annual period. The Company is currently evaluating the effect that the adoption of ASU 2016-09 will have on its financial statements. In April 2016, the FASB issued ASU No. 2016-10, Revenue from Contracts with Customers (Topic 606). ASU 2016-10 amends ASC 606 , which is not yet effective. The effective date and transition requirements for the amendments in ASU No. 2016-10 are the same as the effective date and transition requirements in ASC 606 and any other Topic amended by ASU 2014-09. ASU 2015-14, Revenue from Contracts with Customers (Topic 606): Deferral of the Effective Date, defers the effective date of ASU 2014-09 by one year to annual reporting periods beginning after December 15, 2017, including interim reporting periods within that reporting period. The Company is currently evaluating the effect that the adoption of ASU 2016-10 will have on its financial statements. In May 2016, the FASB issued ASU No. 2016-12, Revenue from Contracts with Customers (Topic 606). ASU 2016-12 amends ASC 606 to address certain issues in the guidance on assessing collectability, presentation of sales taxes, noncash consideration, and completed contracts and contract modifications at transition. The amendments in ASU 2016-12 do not change the core principle of the guidance in ASC 606. The amendments in ASU No. 2016-12 affect the guidance in ASU 2014-09, Revenue from Contracts with Customers (Topic 606) , which is not yet effective. The effective date and transition requirements for the amendments in ASU No. 2016-12 are the same as the effective date and transition requirements in ASC 606 and any other Topic amended by ASU 2014-09. ASU 2015-14, Revenue from Contracts with Customers (Topic 606): Deferral of the Effective Date, defers the effective date of ASU 2014-09 by one year to annual reporting periods beginning after December 15, 2017, including interim reporting periods within that reporting period. The Company is currently evaluating the effect that the adoption of ASU 2016-12 will have on its financial statements. |
Unaudited Interim Financial Sta
Unaudited Interim Financial Statements | 9 Months Ended |
Sep. 30, 2016 | |
Unaudited Interim Financial Statements | |
Unaudited Interim Financial Statements | (3) Unaudited Interim Financial Statements The accompanying unaudited financial statements included herein have been prepared by the Company in accordance with U.S. GAAP for interim financial information and pursuant to the rules and regulations of the Securities and Exchange Commission (the “SEC”). Accordingly, certain information and footnote disclosures normally included in financial statements prepared in accordance with U.S. GAAP have been condensed or omitted pursuant to such rules and regulations. In the opinion of management, all adjustments, consisting of normal recurring adjustments, and disclosures considered necessary for a fair presentation of interim period results have been included. Interim results for the three and nine months ended September 30, 2016 are not necessarily indicative of results that may be expected for the year ending December 31, 2016. For further information, refer to the financial statements and footnotes thereto included in the Company’s Annual Report on Form 10-K for the fiscal year ended December 31, 2015, which was filed with the SEC on March 10, 2016. |
Financial Instruments
Financial Instruments | 9 Months Ended |
Sep. 30, 2016 | |
Financial Instruments | |
Financial Instruments | (4) Financial Instruments The fair value of the Company’s financial instruments is determined and disclosed in accordance with the three-tier fair value hierarchy specified in Note 6, “Fair Value of Assets and Liabilities.” The Company is required to disclose the estimated fair values of its financial instruments. The Company’s financial instruments consist of cash, cash equivalents, available-for-sale investments, receivables and a note payable. The estimated fair values of these financial instruments approximate their carrying values as of September 30, 2016 and December 31, 2015. As of September 30, 2016 and December 31, 2015, the Company did not have any derivatives, hedging instruments or other similar financial instruments except for the note issued under the Company’s loan and security agreement, which is discussed in Note 5(a) to the financial statements included in the Company’s Annual Report on Form 10-K for the year ended December 31, 2015, including put and call features which the Company determined are clearly and closely associated with the debt host and do not require bifurcation as a derivative liability, or the fair value of the feature is immaterial. |
Cash and Cash Equivalents
Cash and Cash Equivalents | 9 Months Ended |
Sep. 30, 2016 | |
Cash and Cash Equivalents | |
Cash and Cash Equivalents | (5) Cash and Cash Equivalents The Company considers all highly liquid investments with maturities of 90 days or less when purchased to be cash equivalents. Cash and cash equivalents at September 30, 2016 and December 31, 2015 consisted of cash and money market funds. |
Fair Value of Assets and Liabil
Fair Value of Assets and Liabilities | 9 Months Ended |
Sep. 30, 2016 | |
Fair Value of Assets and Liabilities | |
Fair Value of Assets and Liabilities | (6) Fair Value of Assets and Liabilities The Company measures fair value at the price that would be received to sell an asset or paid to transfer a liability in an orderly transaction between market participants at the measurement date using assumptions that market participants would use in pricing the asset or liability (the “inputs”) into a three-tier fair value hierarchy. This fair value hierarchy gives the highest priority (Level 1) to quoted prices in active markets for identical assets or liabilities and the lowest priority (Level 3) to unobservable inputs in which little or no market data exists, requiring companies to develop their own assumptions. Observable inputs that do not meet the criteria of Level 1, and include quoted prices for similar assets or liabilities in active markets or quoted prices for identical assets and liabilities in markets that are not active, are categorized as Level 2. Level 3 inputs are those that reflect the Company’s estimates about the assumptions market participants would use in pricing the asset or liability, based on the best information available in the circumstances. Valuation techniques for assets and liabilities measured using Level 3 inputs may include unobservable inputs such as projections, estimates and management’s interpretation of current market data. These unobservable Level 3 inputs are only utilized to the extent that observable inputs are not available or cost-effective to obtain. The Company applies ASU No. 2011-04, Fair Value Measurement (Topic 820), in its fair value measurements and disclosures. The table below presents the assets and liabilities measured and recorded in the financial statements at fair value on a recurring basis at September 30, 2016 and December 31, 2015 categorized by the level of inputs used in the valuation of each asset and liability. Quoted Prices in Active Markets Significant for Identical Other Significant Assets or Observable Unobservable Liabilities Inputs Inputs (In thousands) Total (Level 1) (Level 2) (Level 3) September 30, 2016 Assets Money market funds $ $ $ — $ — Short-term investments – corporate bonds — — Short-term investments – municipal bonds — — Long-term investments – municipal bonds — — Total Assets $ $ $ $ — Total Liabilities $ — $ — $ — $ — December 31, 2015 Assets Money market funds $ $ $ — $ — Short-term investments – commercial paper — — Short-term investments – corporate bonds — — Short-term investments – municipal bonds — — Long-term investments – corporate bonds — — Long-term investments – municipal bonds — — Total Assets $ $ $ $ — Total Liabilities $ — $ — $ — $ — The Level 1 assets consist of money market funds, which are actively traded daily. The Level 2 assets consist of corporate bond, commercial paper and municipal bond investments the fair value of which may not represent actual transactions of identical securities. The fair value of corporate and municipal bonds is generally determined from quoted market prices received from pricing services based upon quoted prices from active markets and/or other significant observable market transactions at fair value. The fair value of commercial paper is generally determined based on the relationship between the investment’s discount rate and the discount rates of the same issuer’s commercial paper available in the market which may not be actively traded daily. Since these fair values may not be based upon actual transactions of identical securities, they are classified as Level 2. Since all investments are classified as available-for-sale securities, any unrealized gains or losses are recorded in accumulated other comprehensive income or loss within stockholders’ equity on the balance sheet. The Company did not elect to measure any other financial assets or liabilities at fair value at September 30, 2016 or December 31, 2015. |
Investments
Investments | 9 Months Ended |
Sep. 30, 2016 | |
Investments | |
Investments | (7) Investments The Company’s available-for-sale investments at fair value consisted of the following at September 30, 2016 and December 31, 2015: September 30, 2016 Gross Gross Estimated Unrealized Unrealized Fair Cost (Losses) Gain Value (In thousands) Short-term investments – corporate bonds Short-term investments – municipal bonds — Total short-term investments Long-term investments – municipal bonds — Total long-term investments — Total investments $ $ $ $ December 31, 2015 Gross Gross Estimated Unrealized Unrealized Fair Cost (Losses) Gains Value (In thousands) Short-term investments – commercial paper $ $ — $ $ Short-term investments – corporate bonds — Short-term investments – municipal bonds — — Total short-term investments Long-term investments – corporate bonds — Long-term investments – municipal bonds Total long-term investments Total investments $ $ $ $ The Company had no realized gains or losses from available-for-sale securities in the nine months ended September 30, 2016 and 2015. There were no losses or other-than-temporary declines in value included in “Interest income” |
Property and Equipment
Property and Equipment | 9 Months Ended |
Sep. 30, 2016 | |
Property and Equipment | |
Property and Equipment | (8) Property and Equipment At September 30, 2016 and December 31, 2015, net property and equipment at cost consisted of the following: September 30, December 31, (In thousands) 2016 2015 Leasehold improvements $ $ Laboratory equipment and other Total property and equipment, at cost Less: Accumulated depreciation and amortization Property and equipment, net $ $ Depreciation and amortization expense on property and equipment was approximately $162,000 and $126,000 in the three months ended September 30, 2016 and 2015, respectively, and $469,000 and $329,000 in the nine months ended September 30, 2016 and 2015, respectively. There were $21,000 and $48,000 in non-cash property returns and additions, respectively, in the nine months ended September 30, 2016 and 2015, respectively. |
Restricted Cash
Restricted Cash | 9 Months Ended |
Sep. 30, 2016 | |
Restricted Cash | |
Restricted Cash | (9) Restricted Cash As part of the Company’s lease arrangement for its office and laboratory facility in Cambridge, Massachusetts, the Company is required to restrict cash held in a certificate of deposit securing a line of credit for the lessor. As of September 30, 2016 and December 31, 2015, the restricted cash amounted to $311,000 held in certificates of deposit securing a line of credit for the lessor. The lease expires August 2017. As such, this amount is reported in Prepaid expenses and other current assets as of September 30, 2016 and in Restricted cash and other assets as of December 31, 2015. |
Comprehensive Loss
Comprehensive Loss | 9 Months Ended |
Sep. 30, 2016 | |
Comprehensive Loss | |
Comprehensive Loss | (10) Comprehensive Loss Comprehensive income (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. Comprehensive loss for the nine months ended September 30, 2016 and 2015 is comprised of reported net loss and any change in net unrealized gains and losses on investments during each period, which is included in accumulated other comprehensive income (loss) on the accompanying balance sheets. The Company applies ASU No. 2011-05, Comprehensive Income, by presenting the components of net income and other comprehensive income as one continuous statement. The following table includes the changes in the accumulated balance of the component of other comprehensive income (loss) for the nine months ended September 30, 2016 and 2015: Nine Months Ended Nine Months Ended September 30, September 30, (In thousands) 2016 2015 Accumulated unrealized loss on available-for-sale securities at beginning of period $ $ Change during the period Accumulated unrealized loss on available-for-sale securities at end of period $ $ |
Collaboration with GlaxoSmithKl
Collaboration with GlaxoSmithKline Intellectual Property Development Limited | 9 Months Ended |
Sep. 30, 2016 | |
Collaboration with GlaxoSmithKline Intellectual Property Development Limited | |
Collaboration with GlaxoSmithKline Intellectual Property Development Limited | (11) Collaboration with GlaxoSmithKline Intellectual Property Development Limited In November 2015, the Company entered into a collaboration and license agreement with GlaxoSmithKline Intellectual Property Development Limited (“GSK”) to license, research, develop and commercialize pharmaceutical compounds from the Company’s 3GA technology for the treatment of selected targets in renal disease (the “GSK Agreement”). The initial collaboration term is currently anticipated to last between two and four years. In connection with the GSK Agreement, GSK identified an initial target for the Company to attempt to identify a potential population of development candidates to address such target under a mutually agreed upon research plan, currently estimated to take 27 months to complete. From the population of identified development candidates, GSK may designate one development candidate in its sole discretion to move forward into clinical development. Once GSK designates a development candidate, GSK would be solely responsible for the development and commercialization activities for that designated development candidate. At any time during the first two years of the GSK Agreement, GSK has the option to select up to two additional targets, for further research under mutually agreed upon research plans. GSK may then designate one development candidate for each additional target, at which time GSK would have sole responsibility to develop and commercialize each such designated development candidate. In accordance with the GSK Agreement, a Joint Steering Committee (“JSC”) was formed with equal representation from Idera and GSK. The responsibilities of the JSC, include, but are not limited to monitoring the progress of the collaboration, reviewing research plans and dealing with disputes that may arise between the parties. If a dispute cannot be resolved by the JSC, GSK has final decision making authority. Under the terms of the GSK Agreement, the Company received a $2,500,000 upfront, non-refundable, non-creditable cash payment upon the execution of the GSK Agreement. The Company is eligible to receive up to approximately $100,000,000 in license, research, clinical development and commercialization milestone payments. Approximately $9,000,000 of these milestone payments are payable by GSK upon the identification of the additional targets, the completion of current and future research plans and the designation of development candidates. Approximately $89,000,000 is payable by GSK upon the achievement of clinical milestones and commercial milestones. In addition, the Company is eligible to receive royalty payments on sales upon commercialization at varying rates of up to five percent on annual net sales, as defined in the GSK Agreement. Accounting Analysis The Company evaluated the GSK Agreement in accordance with the provisions of ASC 605-25. The GSK Agreement contains the following initial deliverables: (i) a collaboration license for Idera’s proprietary technology related to the initial target (the “Collaboration License”), (ii) research services (the “Research Services”), and (iii) participation in the JSC (the “JSC Deliverable”). The Company has determined that GSK’s options to choose up to two additional targets and to purchase additional collaboration licenses for the Company’s proprietary technology related to each additional target are substantive options. GSK is not contractually obligated to exercise the options. Moreover, as a result of the uncertain outcome of the research activities, there is significant uncertainty as to whether GSK will decide to exercise its options for any additional targets. Consequently, the Company is at risk with regard to whether GSK will exercise the options. The Company has determined that GSK’s options to choose up to two additional targets and to purchase additional collaboration licenses for the Company’s proprietary technology related to each additional target are not priced at a significant and incremental discount. The Company has concluded that the Collaboration License does not qualify for separation from the Research Services. As it relates to the assessment of standalone value, the Company has determined that GSK cannot fully exploit the value of the Collaboration License without receipt of the Research Services from the Company. The Research Services involve unique skills and specialized expertise, particularly as it relates to the Company’s proprietary technology, which is not available in the marketplace. Accordingly, GSK must obtain the Research Services from the Company which significantly limits the ability for GSK to utilize the Collaboration License for its intended purpose on a standalone basis. Therefore, the Collaboration License does not have standalone value from the Research Services. As a result, the Collaboration License and the Research Services have been combined as a single unit of accounting (the R&D Services Unit of Accounting). The Company has concluded that the JSC Deliverable identified at the inception of the arrangement has standalone value from the other deliverables noted based on its nature. Factors considered in this determination included, among other things, the capabilities of the collaboration partner, whether any other vendor sells the item separately, whether the value of the deliverable is dependent on the other elements in the arrangement, whether there are other vendors that can provide the items and if the customer could use the item for its intended purpose without the other deliverables in the arrangement. Therefore, the Company has identified two units of accounting in connection with its initial deliverables under the GSK Agreement as follows: (i) R&D Services Unit of Accounting, and (ii) JSC Deliverable. Allocable arrangement consideration at inception of the GSK Agreement is comprised of the up-front payment of $2,500,000, which was allocated to the R&D Services Unit of Accounting. No amount was allocated to the JSC Deliverable because the related best estimate of selling price was determined to be de minimus. The $2,500,000 was recorded as deferred revenue in the Company’s balance sheet and is being recognized as revenue on a straight line basis as the Research Services are delivered over the estimated 27 month research plan period. Payments to be received in connection with GSK’s identification of additional targets and designation of development candidates are considered substantive options as a result of the uncertainties related to the research, development and commercialization activities, and the uncertainty as to whether GSK will exercise the options. The substantive options are not priced at a significant incremental discount. Accordingly, the substantive options are not considered deliverables at the inception of the arrangement and the associated option exercise payments are not accounted for at inception of the agreement. The clinical and commercial milestones provided for in the GSK Agreement are all performance obligations of GSK occurring after the Company has completed its obligations. As a result, they represent contingent revenue to the Company and will be accounted for at the time the contingencies are resolved. The Company will recognize royalty revenue in the period of sale of the related product(s), based on the underlying contract terms, provided that the reported sales are reliably measurable and the Company has no remaining performance obligations, assuming all other revenue recognition criteria are met. The Company recognized as revenue approximately $278,000 and $833,000 of deferred revenue related to the GSK Agreement during the three and nine months ended September 30, 2016, respectively. This revenue is classified as alliance revenue in the accompanying statements of operations and comprehensive loss. There was approximately $1,540,000 of deferred revenue related to the GSK Agreement at September 30, 2016, including approximately $1,111,000 classified as current portion of deferred revenue in the accompanying balance sheet. |
Stock-Based Compensation
Stock-Based Compensation | 9 Months Ended |
Sep. 30, 2016 | |
Stock-Based Compensation | |
Stock-Based Compensation | (12) Stock-Based Compensation The Company recognizes all stock-based payments to employees and directors as expense in the statements of operations and comprehensive loss based on their fair values. The Company records compensation expense over an award’s requisite service period, or vesting period, based on the award’s fair value at the date of grant. The Company’s policy is to charge the fair value of stock options as an expense, adjusted for forfeitures, on a straight-line basis over the vesting period, which is generally four years for employees and three years for directors. The Company recorded charges in Total operating expense of $1,630,000 and $1,144,000 in its statements of operations and comprehensive loss for the three months ended September 30, 2016 and 2015, respectively, and $5,127,000 and $4,013,000 in its statements of operations and comprehensive loss for the nine months ended September 30, 2016 and 2015, respectively, for stock-based compensation expense attributable to stock-based payments made to employees and directors. The fair value of each option award is estimated on the date of grant using the Black-Scholes option-pricing model. The following weighted average assumptions apply to the options to purchase 3,281,000 and 2,228,000 shares of common stock granted to employees and directors during the nine months ended September 30, 2016 and 2015, respectively: Nine Months Ended September 30, 2016 2015 Average risk free interest rate Expected dividend yield — — Expected lives (years) Expected volatility Weighted average grant date fair value of options granted during the period (per share) $ $ Weighted average exercise price of options granted during the period (per share) $ $ The expected lives and the expected volatility of the options granted during the nine months ended September 30, 2016 and 2015 are based on historical experience. All options granted during the nine months ended September 30, 2016 and 2015 were granted at exercise prices equal to the fair market value of the common stock on the dates of grant. |
Net Loss per Common Share
Net Loss per Common Share | 9 Months Ended |
Sep. 30, 2016 | |
Net Loss per Common Share | |
Net Loss per Common Share | (13) Net Loss per Common Share For the three and nine months ended September 30, 2016 and 2015, basic and diluted net loss per common share is computed using the weighted average number of shares of common stock outstanding during the period. Diluted net loss per common share is the same as basic net loss per common share as the effects of the Company’s potential common stock equivalents are antidilutive. Total antidilutive securities were 73,115,102 and 73,444,753 for the nine months ended September 30, 2016 and 2015, respectively, and consist of stock options, preferred stock and warrants. |
Common Stock Warrant Exercises,
Common Stock Warrant Exercises, Stock Option Exercises and Employee Stock Purchases | 9 Months Ended |
Sep. 30, 2016 | |
Common Stock Warrant Exercises, Stock Option Exercises and Employee Stock Purchases | |
Common Stock Warrant Exercises, Stock Option Exercises and Employee Stock Purchases | (14) Common Stock Warrant Exercises, Stock Option Exercises and Employee Stock Purchases The Company issued common stock Nine Months Ended Nine Months Ended September 30, 2016 September 30, 2015 (In thousands) Shares Proceeds Shares Proceeds Warrant exercises — $ — $ Stock option exercises — — Employee stock purchases Total $ $ |
Related Party Transactions
Related Party Transactions | 9 Months Ended |
Sep. 30, 2016 | |
Related Party Transactions | |
Related Party Transactions | (15) Related Party Transactions The Company issued 66,915 and 23,689 shares of common stock in lieu of director board and committee fees of approximately $129,000 and $90,000 pursuant to the Company’s director compensation program during the nine months ended September 30, 2016 and 2015, respectively. See also Note 17, “Financing” and Note 18, “Subsequent Events” for additional information on related party transactions. |
Deferred Tax Assets
Deferred Tax Assets | 9 Months Ended |
Sep. 30, 2016 | |
Deferred Tax Assets | |
Deferred Tax Assets | (16) Deferred Tax Assets The Company’s deferred tax assets are determined based on temporary differences between the financial reporting and tax bases of assets and are measured using the enacted tax rates and laws that will be in effect when the differences are expected to reverse. A valuation allowance is recorded against deferred tax assets if it is more likely than not that some portion or all of the deferred tax assets will not be realized. For the nine months ended September 30, 2016 and 2015, the Company did not record any current or deferred income tax provisions or benefits. Due to the uncertainty surrounding the future realization of the deferred tax assets, the Company has recorded full valuation allowances against its otherwise recognizable deferred tax assets at September 30, 2016 and December 31, 2015. |
Financing
Financing | 9 Months Ended |
Sep. 30, 2016 | |
Financing | |
Financing | (17) Financing On February 19, 2015, the Company closed a follow-on underwritten public offering, in which it sold 23,000,000 shares of common stock at a price to the public of $3.75 per share for aggregate gross proceeds of $86.3 million. The net proceeds to the Company from the offering, after deducting underwriters’ discounts and commissions and other offering costs and expenses, were $80.6 million. Investment funds affiliated with Baker Bros. Advisors LP, one of the Company’s principal stockholders, and two members of the Company’s board of directors purchased 5,333,333 shares in this offering at the $3.75 per share purchase price. |
Subsequent Events
Subsequent Events | 9 Months Ended |
Sep. 30, 2016 | |
Subsequent Events | |
Subsequent Events | (18) Subsequent Events On October 13, 2016, the Company closed a follow-on underwritten public offering, in which it sold 25,000,000 shares of common stock at a price to the public of $2.00 per share for aggregate gross proceeds of $50.0 million. On October 28, 2016, the Company sold an additional 1,225,243 shares of common stock pursuant to the underwriters’ 30-day option to purchase additional shares at the public offering price less the underwriting discount. The estimated net proceeds to the Company from the offering, including the exercise by the underwriters of their option to purchase additional shares and after deducting underwriters’ discounts and commissions and other offering costs and expenses, were approximately $48.9 million. Investment funds affiliated with Baker Bros. Advisors LP and Pillar Invest Corporation, two of the Company’s principal stockholders, and certain members of the Company’s board of directors, purchased 5,125,000 shares in this offering at the $2.00 per share purchase price. As of October 13, 2016, Baker Bros. Advisors LP, and certain of its affiliated funds held 10,272,314 shares of the Company’s common stock, warrants to purchase up to 20,316,327 shares of the Company’s common stock at an exercise price of $0.47 per share and pre-funded warrants to purchase up to 22,151,052 shares of the Company’s common stock at an exercise price of $0.01 per share. As of October 13, 2016, entities affiliated with Pillar Invest Corporation held 20,346,942 shares of the Company’s common stock and warrants to purchase up to 11,962,731 shares of the Company’s common stock at exercise prices ranging from $0.47 per share to $1.46 per share. |
Fair Value of Assets and Liab24
Fair Value of Assets and Liabilities (Tables) | 9 Months Ended |
Sep. 30, 2016 | |
Fair Value of Assets and Liabilities | |
Schedule of assets and liabilities measured and recorded in financial statements at fair value on a recurring basis | Quoted Prices in Active Markets Significant for Identical Other Significant Assets or Observable Unobservable Liabilities Inputs Inputs (In thousands) Total (Level 1) (Level 2) (Level 3) September 30, 2016 Assets Money market funds $ $ $ — $ — Short-term investments – corporate bonds — — Short-term investments – municipal bonds — — Long-term investments – municipal bonds — — Total Assets $ $ $ $ — Total Liabilities $ — $ — $ — $ — December 31, 2015 Assets Money market funds $ $ $ — $ — Short-term investments – commercial paper — — Short-term investments – corporate bonds — — Short-term investments – municipal bonds — — Long-term investments – corporate bonds — — Long-term investments – municipal bonds — — Total Assets $ $ $ $ — Total Liabilities $ — $ — $ — $ — |
Investments (Tables)
Investments (Tables) | 9 Months Ended |
Sep. 30, 2016 | |
Investments | |
Schedule of available-for-sale investments at fair value | September 30, 2016 Gross Gross Estimated Unrealized Unrealized Fair Cost (Losses) Gain Value (In thousands) Short-term investments – corporate bonds Short-term investments – municipal bonds — Total short-term investments Long-term investments – municipal bonds — Total long-term investments — Total investments $ $ $ $ December 31, 2015 Gross Gross Estimated Unrealized Unrealized Fair Cost (Losses) Gains Value (In thousands) Short-term investments – commercial paper $ $ — $ $ Short-term investments – corporate bonds — Short-term investments – municipal bonds — — Total short-term investments Long-term investments – corporate bonds — Long-term investments – municipal bonds Total long-term investments Total investments $ $ $ $ |
Property and Equipment (Tables)
Property and Equipment (Tables) | 9 Months Ended |
Sep. 30, 2016 | |
Property and Equipment | |
Schedule of net property and equipment at cost | September 30, December 31, (In thousands) 2016 2015 Leasehold improvements $ $ Laboratory equipment and other Total property and equipment, at cost Less: Accumulated depreciation and amortization Property and equipment, net $ $ |
Comprehensive Loss (Tables)
Comprehensive Loss (Tables) | 9 Months Ended |
Sep. 30, 2016 | |
Comprehensive Loss | |
Schedule of changes in accumulated balance of the component of other comprehensive income (loss) | Nine Months Ended Nine Months Ended September 30, September 30, (In thousands) 2016 2015 Accumulated unrealized loss on available-for-sale securities at beginning of period $ $ Change during the period Accumulated unrealized loss on available-for-sale securities at end of period $ $ |
Stock-Based Compensation (Table
Stock-Based Compensation (Tables) | 9 Months Ended |
Sep. 30, 2016 | |
Stock-Based Compensation | |
Schedule of weighted average assumptions applied to options | Nine Months Ended September 30, 2016 2015 Average risk free interest rate Expected dividend yield — — Expected lives (years) Expected volatility Weighted average grant date fair value of options granted during the period (per share) $ $ Weighted average exercise price of options granted during the period (per share) $ $ |
Common Stock Warrant Exercise29
Common Stock Warrant Exercises, Stock Option Exercises and Employee Stock Purchases (Tables) | 9 Months Ended |
Sep. 30, 2016 | |
Common Stock Warrant Exercises, Stock Option Exercises and Employee Stock Purchases | |
Schedule of ommon stock a result of warrant exercises, stock option exercises and employee stock purchases | Nine Months Ended Nine Months Ended September 30, 2016 September 30, 2015 (In thousands) Shares Proceeds Shares Proceeds Warrant exercises — $ — $ Stock option exercises — — Employee stock purchases Total $ $ |
Organization (Details)
Organization (Details) $ in Thousands | 9 Months Ended | |
Sep. 30, 2016USD ($)item | Dec. 31, 2015USD ($) | |
Organization | ||
Accumulated deficit | $ | $ 539,292 | $ 500,081 |
Number of technology platforms to develop drug candidates | item | 2 |
New Accounting Pronouncements31
New Accounting Pronouncements - Recently Issued (Details) - USD ($) $ in Millions | Oct. 13, 2016 | Feb. 19, 2015 | Sep. 30, 2016 |
New Accounting Pronouncements or Change in Accounting Principle | |||
Gross proceeds from offering of common stock | $ 86.3 | ||
Net proceeds from offering of common stock | $ 48.9 | $ 80.6 | |
Accounting Standards Update 2016-02 | Minimum | |||
New Accounting Pronouncements or Change in Accounting Principle | |||
Lease term | 12 months |
Fair Value of Assets and Liab32
Fair Value of Assets and Liabilities (Details) - USD ($) $ in Thousands | Sep. 30, 2016 | Dec. 31, 2015 |
Fair Value of Assets and Liabilities Measured at Fair Value on a Recurring Basis | ||
Short-term investments | $ 29,856 | $ 33,574 |
Long-term investments | 1,408 | 26,997 |
Short-term investments | ||
Fair Value of Assets and Liabilities Measured at Fair Value on a Recurring Basis | ||
Short-term investments | 29,856 | 33,574 |
Short-term investments | Corporate bonds | ||
Fair Value of Assets and Liabilities Measured at Fair Value on a Recurring Basis | ||
Short-term investments | 22,591 | 24,575 |
Short-term investments | Municipal bonds | ||
Fair Value of Assets and Liabilities Measured at Fair Value on a Recurring Basis | ||
Short-term investments | 7,265 | 5,025 |
Short-term investments | Commercial paper | ||
Fair Value of Assets and Liabilities Measured at Fair Value on a Recurring Basis | ||
Short-term investments | 3,974 | |
Long-term investments | ||
Fair Value of Assets and Liabilities Measured at Fair Value on a Recurring Basis | ||
Long-term investments | 1,408 | 26,997 |
Long-term investments | Corporate bonds | ||
Fair Value of Assets and Liabilities Measured at Fair Value on a Recurring Basis | ||
Long-term investments | 21,186 | |
Long-term investments | Municipal bonds | ||
Fair Value of Assets and Liabilities Measured at Fair Value on a Recurring Basis | ||
Long-term investments | 1,408 | 5,811 |
Fair value on a recurring basis | ||
Fair Value of Assets and Liabilities Measured at Fair Value on a Recurring Basis | ||
Long-term investments | 5,811 | |
Total Assets | 52,911 | 86,627 |
Fair value on a recurring basis | Money market funds | ||
Fair Value of Assets and Liabilities Measured at Fair Value on a Recurring Basis | ||
Money market funds | 21,647 | 26,056 |
Fair value on a recurring basis | Short-term investments | Corporate bonds | ||
Fair Value of Assets and Liabilities Measured at Fair Value on a Recurring Basis | ||
Short-term investments | 22,591 | 24,575 |
Fair value on a recurring basis | Short-term investments | Municipal bonds | ||
Fair Value of Assets and Liabilities Measured at Fair Value on a Recurring Basis | ||
Short-term investments | 7,265 | 5,025 |
Fair value on a recurring basis | Short-term investments | Commercial paper | ||
Fair Value of Assets and Liabilities Measured at Fair Value on a Recurring Basis | ||
Short-term investments | 3,974 | |
Fair value on a recurring basis | Long-term investments | Corporate bonds | ||
Fair Value of Assets and Liabilities Measured at Fair Value on a Recurring Basis | ||
Long-term investments | 21,186 | |
Fair value on a recurring basis | Long-term investments | Municipal bonds | ||
Fair Value of Assets and Liabilities Measured at Fair Value on a Recurring Basis | ||
Long-term investments | 1,408 | |
Level 1 | Fair value on a recurring basis | ||
Fair Value of Assets and Liabilities Measured at Fair Value on a Recurring Basis | ||
Total Assets | 21,647 | 26,056 |
Level 1 | Fair value on a recurring basis | Money market funds | ||
Fair Value of Assets and Liabilities Measured at Fair Value on a Recurring Basis | ||
Money market funds | 21,647 | 26,056 |
Level 2 | Fair value on a recurring basis | ||
Fair Value of Assets and Liabilities Measured at Fair Value on a Recurring Basis | ||
Long-term investments | 5,811 | |
Total Assets | 31,264 | 60,571 |
Level 2 | Fair value on a recurring basis | Short-term investments | Corporate bonds | ||
Fair Value of Assets and Liabilities Measured at Fair Value on a Recurring Basis | ||
Short-term investments | 22,591 | 24,575 |
Level 2 | Fair value on a recurring basis | Short-term investments | Municipal bonds | ||
Fair Value of Assets and Liabilities Measured at Fair Value on a Recurring Basis | ||
Short-term investments | 7,265 | 5,025 |
Level 2 | Fair value on a recurring basis | Short-term investments | Commercial paper | ||
Fair Value of Assets and Liabilities Measured at Fair Value on a Recurring Basis | ||
Short-term investments | 3,974 | |
Level 2 | Fair value on a recurring basis | Long-term investments | Corporate bonds | ||
Fair Value of Assets and Liabilities Measured at Fair Value on a Recurring Basis | ||
Long-term investments | $ 21,186 | |
Level 2 | Fair value on a recurring basis | Long-term investments | Municipal bonds | ||
Fair Value of Assets and Liabilities Measured at Fair Value on a Recurring Basis | ||
Long-term investments | $ 1,408 |
Investments - Summary of Availa
Investments - Summary of Available-for-Sale Investments at Fair Value (Details) - USD ($) $ in Thousands | Sep. 30, 2016 | Dec. 31, 2015 |
Schedule of Available-for-sale Securities | ||
Cost | $ 31,265 | $ 60,705 |
Gross Unrealized (Losses) | (13) | (137) |
Gross Unrealized Gains | 12 | 3 |
Estimated Fair Value | 31,264 | 60,571 |
Estimated Fair Value - Short-term investments | 29,856 | 33,574 |
Estimated Fair Value - Long-term investments | 1,408 | 26,997 |
Short-term investments | ||
Schedule of Available-for-sale Securities | ||
Cost | 29,860 | 33,598 |
Gross Unrealized (Losses) | (13) | (25) |
Gross Unrealized Gains | 9 | 1 |
Estimated Fair Value - Short-term investments | 29,856 | 33,574 |
Short-term investments | Corporate bonds | ||
Schedule of Available-for-sale Securities | ||
Cost | 22,603 | 24,600 |
Gross Unrealized (Losses) | (13) | (25) |
Gross Unrealized Gains | 1 | |
Estimated Fair Value - Short-term investments | 22,591 | 24,575 |
Short-term investments | Municipal bonds | ||
Schedule of Available-for-sale Securities | ||
Cost | 7,257 | 5,025 |
Gross Unrealized Gains | 8 | |
Estimated Fair Value - Short-term investments | 7,265 | 5,025 |
Short-term investments | Commercial paper | ||
Schedule of Available-for-sale Securities | ||
Cost | 3,973 | |
Gross Unrealized Gains | 1 | |
Estimated Fair Value - Short-term investments | 3,974 | |
Long-term investments | ||
Schedule of Available-for-sale Securities | ||
Cost | 1,405 | 27,107 |
Gross Unrealized (Losses) | (112) | |
Gross Unrealized Gains | 3 | 2 |
Estimated Fair Value - Long-term investments | 1,408 | 26,997 |
Long-term investments | Corporate bonds | ||
Schedule of Available-for-sale Securities | ||
Cost | 21,289 | |
Gross Unrealized (Losses) | (103) | |
Estimated Fair Value - Long-term investments | 21,186 | |
Long-term investments | Municipal bonds | ||
Schedule of Available-for-sale Securities | ||
Cost | 1,405 | 5,818 |
Gross Unrealized (Losses) | (9) | |
Gross Unrealized Gains | 3 | 2 |
Estimated Fair Value - Long-term investments | $ 1,408 | $ 5,811 |
Investments - Additional Inform
Investments - Additional Information (Details) - USD ($) $ in Thousands | 9 Months Ended | ||
Sep. 30, 2016 | Sep. 30, 2015 | Dec. 31, 2015 | |
Investments | |||
Realized gains or losses from available-for-sale securities | $ 0 | $ 0 | |
Losses from investments | 0 | $ 0 | |
Auction rate securities, noncurrent | $ 0 | $ 0 |
Property and Equipment - Tabula
Property and Equipment - Tabular Disclosure of Major Components of Property and Equipment and Related Accumulated Depreciation (Details) - USD ($) $ in Thousands | Sep. 30, 2016 | Dec. 31, 2015 |
Property, Plant and Equipment | ||
Total property and equipment, at cost | $ 5,457 | $ 5,146 |
Less: accumulated depreciation and amortization | 3,878 | 3,454 |
Property and equipment, net | 1,579 | 1,692 |
Leasehold improvements | ||
Property, Plant and Equipment | ||
Total property and equipment, at cost | 671 | 603 |
Laboratory equipment and other | ||
Property, Plant and Equipment | ||
Total property and equipment, at cost | $ 4,786 | $ 4,543 |
Property and Equipment - Additi
Property and Equipment - Additional Information (Details) - USD ($) | 3 Months Ended | 9 Months Ended | ||
Sep. 30, 2016 | Sep. 30, 2015 | Sep. 30, 2016 | Sep. 30, 2015 | |
Property and Equipment | ||||
Depreciation and amortization expense on property and equipment | $ 162,000 | $ 126,000 | $ 469,000 | $ 329,000 |
Non-cash property additions | $ 21,000 | $ 48,000 |
Restricted Cash (Details)
Restricted Cash (Details) - USD ($) | Sep. 30, 2016 | Dec. 31, 2015 |
Restricted Cash | ||
Total restricted cash | $ 311,000 | $ 311,000 |
Comprehensive Loss (Details)
Comprehensive Loss (Details) - USD ($) $ in Thousands | 3 Months Ended | 9 Months Ended | ||
Sep. 30, 2016 | Sep. 30, 2015 | Sep. 30, 2016 | Sep. 30, 2015 | |
Comprehensive Loss | ||||
Accumulated unrealized loss on available-for-sale securities at beginning of period | $ (134) | $ (17) | ||
Change during the period | $ 13 | $ 50 | 133 | (10) |
Accumulated unrealized income (loss) on available-for-sale securities at end of period | $ (1) | $ (27) | $ (1) | $ (27) |
Collaboration with GlaxoSmith39
Collaboration with GlaxoSmithKline Intellectual Property Development Limited (Details) | 1 Months Ended | 3 Months Ended | 9 Months Ended | ||||||
Nov. 30, 2015 | Sep. 30, 2016USD ($) | Sep. 30, 2015USD ($) | Sep. 30, 2016USD ($) | Sep. 30, 2016USD ($)item | Sep. 30, 2016USD ($)agreement | Sep. 30, 2016USD ($) | Sep. 30, 2015USD ($) | Dec. 31, 2015USD ($) | |
Collaborative Arrangements and Non-collaborative Arrangement Transactions | |||||||||
Alliance revenue | $ 323,000 | $ 20,000 | $ 918,000 | $ 59,000 | |||||
Deferred revenue, current portion | 1,111,000 | $ 1,111,000 | $ 1,111,000 | $ 1,111,000 | 1,111,000 | $ 1,111,000 | |||
Deferred revenue, net of current portion | 429,000 | 429,000 | $ 429,000 | 429,000 | 429,000 | $ 1,262,000 | |||
GlaxoSmithKline plc Agreement | |||||||||
Collaborative Arrangements and Non-collaborative Arrangement Transactions | |||||||||
Deferred revenue recognition period | 27 months | ||||||||
Number of development candidates. | item | 1 | ||||||||
Number of units of accounting in connection of agreements | item | 2 | ||||||||
Alliance revenue | 278,000 | 833,000 | |||||||
Deferred revenue | $ 1,540,000 | $ 1,540,000 | $ 1,540,000 | $ 1,540,000 | 1,540,000 | ||||
GlaxoSmithKline plc Agreement | Clinical and Commercial Milestones | |||||||||
Collaborative Arrangements and Non-collaborative Arrangement Transactions | |||||||||
Maximum milestone payments | 89,000,000 | ||||||||
GlaxoSmithKline plc Agreement | Maximum | |||||||||
Collaborative Arrangements and Non-collaborative Arrangement Transactions | |||||||||
Anticipated initial collaboration term | 4 years | ||||||||
Number of optional additional targets | 2 | 2 | |||||||
Maximum royalty percentage on net sales | 5.00% | ||||||||
GlaxoSmithKline plc Agreement | Maximum | License, Research, Clinical Development and Commercialization | |||||||||
Collaborative Arrangements and Non-collaborative Arrangement Transactions | |||||||||
Maximum milestone payments | 100,000,000 | ||||||||
GlaxoSmithKline plc Agreement | Maximum | Research and Development Plans and Designation of Development Candidates | |||||||||
Collaborative Arrangements and Non-collaborative Arrangement Transactions | |||||||||
Maximum milestone payments | 9,000,000 | ||||||||
GlaxoSmithKline plc Agreement | Minimum | |||||||||
Collaborative Arrangements and Non-collaborative Arrangement Transactions | |||||||||
Anticipated initial collaboration term | 2 years | ||||||||
Up-front Payment Arrangement | GlaxoSmithKline plc Agreement | |||||||||
Collaborative Arrangements and Non-collaborative Arrangement Transactions | |||||||||
Upfront payment received under collaboration | $ 2,500,000 |
Stock-Based Compensation - Addi
Stock-Based Compensation - Additional Information (Details) - USD ($) | 3 Months Ended | 9 Months Ended | ||
Sep. 30, 2016 | Sep. 30, 2015 | Sep. 30, 2016 | Sep. 30, 2015 | |
Share-based Compensation Arrangement by Share-based Payment Award | ||||
Stock-based compensation | $ 1,630,000 | $ 1,144,000 | $ 5,127,000 | $ 4,013,000 |
Options to purchase common stock granted to employees and directors | 3,281,000 | 2,228,000 | ||
Employees | ||||
Share-based Compensation Arrangement by Share-based Payment Award | ||||
Stock options, vesting period | 4 years | |||
Directors | ||||
Share-based Compensation Arrangement by Share-based Payment Award | ||||
Stock options, vesting period | 3 years |
Stock-Based Compensation - Sche
Stock-Based Compensation - Schedule of Assumptions Used to Determine Fair Value of Stock Options Granted During Period (Details) - $ / shares | 9 Months Ended | |
Sep. 30, 2016 | Sep. 30, 2015 | |
Stock-Based Compensation | ||
Average risk free interest rate | 1.40% | 1.30% |
Expected lives (years) | 4 years 2 months 12 days | 4 years 3 months 18 days |
Expected volatility | 92.80% | 92.00% |
Weighted average grant date fair value of options granted during the period (per share) | $ 1.77 | $ 2.57 |
Weighted average exercise price of options granted during the period (per share) | $ 2.65 | $ 3.85 |
Net Loss per Common Share (Deta
Net Loss per Common Share (Details) - shares | 9 Months Ended | |
Sep. 30, 2016 | Sep. 30, 2015 | |
Net Loss per Common Share | ||
Total antidilutive securities | 73,115,102 | 73,444,753 |
Common Stock Warrant Exercise43
Common Stock Warrant Exercises, Stock Option Exercises and Employee Stock Purchases (Details) - USD ($) shares in Thousands, $ in Thousands | 9 Months Ended | |
Sep. 30, 2016 | Sep. 30, 2015 | |
Common Stock Warrant Exercises, Stock Option Exercises and Employee Stock Purchases | ||
Warrant exercises, Shares | 136 | |
Stock option exercises, Shares | 332 | |
Employee stock purchases, Shares | 79 | 19 |
Total, Shares | 79 | 487 |
Warrant exercises, Proceeds | $ 503 | |
Stock option exercises, Proceeds | (431) | |
Employee stock purchases, Proceeds | $ (111) | (53) |
Total, Proceeds | $ 111 | $ 987 |
Related Party Transactions (Det
Related Party Transactions (Details) - Directors - USD ($) | 9 Months Ended | |
Sep. 30, 2016 | Sep. 30, 2015 | |
Related Party Transactions | ||
Common stock issued in lieu of board fees | 66,915 | 23,689 |
Issuance of common stock for services | $ 129,000 | $ 90,000 |
Financing (Details)
Financing (Details) - USD ($) $ / shares in Units, $ in Millions | Oct. 13, 2016 | Feb. 19, 2015 |
Class of Stock | ||
Stock issued (in shares) | 23,000,000 | |
Stock price (in dollars per share) | $ 3.75 | |
Gross proceeds from offering of common stock | $ 86.3 | |
Net proceeds from offering of common stock | $ 48.9 | $ 80.6 |
Baker Bros. Advisors LP | Directors | ||
Class of Stock | ||
Stock issued (in shares) | 5,333,333 | |
Stock price (in dollars per share) | $ 3.75 |
Subsequent Events (Details)
Subsequent Events (Details) - USD ($) $ / shares in Units, $ in Millions | Oct. 28, 2016 | Oct. 13, 2016 | Feb. 19, 2015 | Sep. 30, 2016 | Dec. 31, 2015 |
Subsequent Events | |||||
Stock issued (in shares) | 23,000,000 | ||||
Common stock, price per share | $ 3.75 | ||||
Gross proceeds from offering of common stock | $ 86.3 | ||||
Net proceeds from offering of common stock | $ 48.9 | $ 80.6 | |||
Common stock shares held | 121,411,000 | 121,265,000 | |||
Baker Bros. Advisors LP | Directors | |||||
Subsequent Events | |||||
Stock issued (in shares) | 5,333,333 | ||||
Common stock, price per share | $ 3.75 | ||||
Subsequent Events | |||||
Subsequent Events | |||||
Stock issued (in shares) | 1,225,243 | 25,000,000 | |||
Common stock, price per share | $ 2 | ||||
Gross proceeds from offering of common stock | $ 50 | ||||
Net proceeds from offering of common stock | $ 48.9 | ||||
Period granted by the Company to underwriters to purchase additional shares | 30 days | ||||
Subsequent Events | Investment funds | Directors | |||||
Subsequent Events | |||||
Stock issued (in shares) | 5,125,000 | ||||
Common stock, price per share | $ 2 | ||||
Subsequent Events | Baker Bros. Advisors LP | |||||
Subsequent Events | |||||
Common stock shares held | 10,272,314 | ||||
Subsequent Events | Baker Bros. Advisors LP | Warrants | |||||
Subsequent Events | |||||
Warrant exercise price per share | $ 0.47 | ||||
Subsequent Events | Baker Bros. Advisors LP | Warrants | Maximum | |||||
Subsequent Events | |||||
Shares of common stock that may be purchased upon exercise of warrants | 20,316,327 | ||||
Subsequent Events | Baker Bros. Advisors LP | Pre-funded Warrants | |||||
Subsequent Events | |||||
Warrant exercise price per share | $ 0.01 | ||||
Subsequent Events | Baker Bros. Advisors LP | Pre-funded Warrants | Maximum | |||||
Subsequent Events | |||||
Shares of common stock that may be purchased upon exercise of warrants | 22,151,052 | ||||
Subsequent Events | Pillar Invest Corporation | |||||
Subsequent Events | |||||
Common stock shares held | 20,346,942 | ||||
Subsequent Events | Pillar Invest Corporation | Warrants | Maximum | |||||
Subsequent Events | |||||
Shares of common stock that may be purchased upon exercise of warrants | 11,962,731 | ||||
Warrant exercise price per share | $ 1.46 | ||||
Subsequent Events | Pillar Invest Corporation | Warrants | Minimum | |||||
Subsequent Events | |||||
Warrant exercise price per share | $ 0.47 |