Document and Entity Information
Document and Entity Information - shares | 6 Months Ended | |
Jun. 30, 2019 | Jul. 31, 2019 | |
Document and Entity Information | ||
Entity Registrant Name | IDERA PHARMACEUTICALS, INC. | |
Entity Central Index Key | 0000861838 | |
Document Type | 10-Q | |
Document Period End Date | Jun. 30, 2019 | |
Amendment Flag | false | |
Current Fiscal Year End Date | --12-31 | |
Entity Current Reporting Status | Yes | |
Entity Interactive Data Current | Yes | |
Entity Filer Category | Accelerated Filer | |
Entity Small Business | true | |
Entity Emerging Growth Company | false | |
Entity Shell Company | false | |
Entity Common Stock, Shares Outstanding | 28,843,528 | |
Document Fiscal Year Focus | 2019 | |
Document Fiscal Period Focus | Q2 |
CONDENSED BALANCE SHEETS
CONDENSED BALANCE SHEETS - USD ($) $ in Thousands | Jun. 30, 2019 | Dec. 31, 2018 |
Current assets: | ||
Cash and cash equivalents | $ 39,884 | $ 71,431 |
Short-term investments | 12,489 | |
Prepaid expenses and other current assets | 1,567 | 1,376 |
Total current assets | 53,940 | 72,807 |
Property and equipment, net | 151 | 207 |
Operating lease right-of-use asset | 171 | |
Other assets | 70 | 9 |
Total assets | 54,332 | 73,023 |
Current liabilities: | ||
Accounts payable | 457 | 1,134 |
Accrued expenses | 5,939 | 7,884 |
Operating lease liability | 189 | |
Total current liabilities | 6,585 | 9,018 |
Other liabilities | 12 | 11 |
Total liabilities | 6,597 | 9,029 |
Commitments and contingencies | ||
Stockholders' equity: | ||
Common stock, $0.001 par value, Authorized — 70,000 shares; Issued and outstanding — 28,827 and 27,188 shares at June 30, 2019 and December 31, 2018, respectively | 29 | 27 |
Additional paid-in capital | 734,229 | 728,342 |
Accumulated deficit | (686,525) | (664,375) |
Accumulated other comprehensive income | 2 | |
Total stockholders' equity | 47,735 | 63,994 |
Total liabilities and stockholders' equity | 54,332 | 73,023 |
Series A Preferred Stock | ||
Stockholders' equity: | ||
Preferred stock, $0.01 par value, Authorized — 5,000 shares: Series A convertible preferred stock; Designated — 1,500 shares, Issued and outstanding — 1 share |
CONDENSED BALANCE SHEETS (Paren
CONDENSED BALANCE SHEETS (Parenthetical) - $ / shares | Jun. 30, 2019 | Dec. 31, 2018 |
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 | 70,000,000 | 70,000,000 |
Common stock, shares issued | 28,827,000 | 27,188,000 |
Common stock, shares outstanding | 28,827,000 | 27,188,000 |
Series A 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 | 6 Months Ended | ||
Jun. 30, 2019 | Jun. 30, 2018 | Jun. 30, 2019 | Jun. 30, 2018 | |
CONDENSED STATEMENTS OF OPERATIONS AND COMPREHENSIVE LOSS | ||||
Alliance revenue | $ 1,448 | $ 163 | $ 1,448 | $ 418 |
Revenue, Product and Service [Extensible List] | us_gaap:RevenueFromContractWithCustomerIncludingAssessedTax | us_gaap:RevenueFromContractWithCustomerIncludingAssessedTax | us_gaap:RevenueFromContractWithCustomerIncludingAssessedTax | us_gaap:RevenueFromContractWithCustomerIncludingAssessedTax |
Operating expenses: | ||||
Research and development | $ 10,024 | $ 10,880 | $ 18,126 | $ 24,436 |
General and administrative | 2,895 | 4,000 | 6,038 | 7,481 |
Merger-related costs, net | 1,583 | 5,081 | ||
Restructuring costs | 45 | 176 | ||
Total operating expenses | 12,964 | 16,463 | 24,340 | 36,998 |
Loss from operations | (11,516) | (16,300) | (22,892) | (36,580) |
Other income (expense): | ||||
Interest income | 339 | 271 | 743 | 482 |
Interest expense | (4) | (11) | ||
Foreign currency exchange loss | 1 | 2 | (1) | (17) |
Net loss | $ (11,176) | $ (16,031) | $ (22,150) | $ (36,126) |
Net loss per share applicable to common stockholders - basic and diluted (Note 13) | $ (0.39) | $ (0.59) | $ (0.79) | $ (1.39) |
Weighted-average number of common shares used in computing net loss per share applicable to common stockholders - basic and diluted | 28,461 | 27,133 | 28,070 | 26,012 |
Comprehensive loss: | ||||
Net loss | $ (11,176) | $ (16,031) | $ (22,150) | $ (36,126) |
Unrealized gain on available-for-sale securities | 2 | |||
Total other comprehensive income | 2 | |||
Comprehensive loss | $ (11,176) | $ (16,031) | $ (22,148) | $ (36,126) |
CONDENSED STATEMENTS OF CASH FL
CONDENSED STATEMENTS OF CASH FLOWS - USD ($) $ in Thousands | 6 Months Ended | |
Jun. 30, 2019 | Jun. 30, 2018 | |
Cash Flows from Operating Activities: | ||
Net loss | $ (22,150) | $ (36,126) |
Adjustments to reconcile net loss to net cash used in operating activities: | ||
Stock-based compensation | 1,905 | 3,127 |
Issuance of common stock for services rendered | 59 | 45 |
Accretion of discounts on short-term investments | (353) | |
Unrealized gain on available-for-sale securities | 2 | |
Depreciation and amortization expense | 67 | 321 |
Gain on disposal of property and equipment | (11) | |
Changes in operating assets and liabilities: | ||
Prepaid expenses and other assets | (423) | 69 |
Accounts payable, accrued expenses, and other liabilities | (2,426) | 4,243 |
Deferred revenue | (331) | |
Net cash used in operating activities | (23,330) | (28,652) |
Cash Flows from Investing Activities: | ||
Purchases of available-for-sale securities | (35,486) | |
Proceeds from maturity of available-for-sale securities | 23,350 | |
Proceeds from the sale of property and equipment | 11 | |
Purchases of property and equipment | (11) | (42) |
Net cash used in investing activities | (12,136) | (42) |
Cash Flows from Financing Activities: | ||
Proceeds from equity financings, net of issuance costs | 3,857 | |
Proceeds from employee stock purchases | 68 | 159 |
Proceeds from exercise of common stock options and warrants | 10,166 | |
Payments on note payable | (209) | |
Other | (6) | (5) |
Net cash provided by financing activities | 3,919 | 10,111 |
Net decrease in cash and cash equivalents | (31,547) | (18,583) |
Cash, cash equivalents and restricted cash, beginning of period | 71,431 | 112,940 |
Cash, cash equivalents and restricted cash, end of period | $ 39,884 | $ 94,357 |
CONDENSED STATEMENTS OF STOCKHO
CONDENSED STATEMENTS OF STOCKHOLDERS' EQUITY - USD ($) $ in Thousands | Common Stock | Additional Paid-in Capital | Accumulated Deficit | Accumulated Other Comprehensive Income | Total |
Beginning balance at Dec. 31, 2017 | $ 24 | $ 712,165 | $ (604,494) | $ 107,695 | |
Beginning balance (in shares) at Dec. 31, 2017 | 24,453,000 | ||||
Issuance of common stock under employee stock purchase plan | 81 | 81 | |||
Issuance of common stock under employee stock purchase plan (in shares) | 7,000 | ||||
Issuance of common stock upon exercise of common stock warrants | $ 3 | 9,588 | 9,591 | ||
Issuance of common stock upon exercise of common stock warrants (in shares) | 2,551,000 | ||||
Issuance of common stock for services rendered | 23 | 23 | |||
Issuance of common stock for services rendered (in shares) | 1,000 | ||||
Stock-based compensation | 1,589 | 1,589 | |||
Net loss | (20,095) | (20,095) | |||
Ending balance at Mar. 31, 2018 | $ 27 | 723,446 | (624,589) | 98,884 | |
Ending balance (in shares) at Mar. 31, 2018 | 27,012,000 | ||||
Beginning balance at Dec. 31, 2017 | $ 24 | 712,165 | (604,494) | 107,695 | |
Beginning balance (in shares) at Dec. 31, 2017 | 24,453,000 | ||||
Net loss | (36,126) | ||||
Ending balance at Jun. 30, 2018 | $ 27 | 725,659 | (640,620) | 85,066 | |
Ending balance (in shares) at Jun. 30, 2018 | 27,171,000 | ||||
Beginning balance at Mar. 31, 2018 | $ 27 | 723,446 | (624,589) | 98,884 | |
Beginning balance (in shares) at Mar. 31, 2018 | 27,012,000 | ||||
Issuance of common stock under employee stock purchase plan | 78 | 78 | |||
Issuance of common stock under employee stock purchase plan (in shares) | 6,000 | ||||
Issuance of common stock upon exercise of common stock options and warrants | 575 | 575 | |||
Issuance of common stock upon exercise of common stock options and warrants (in shares) | 151,000 | ||||
Issuance of common stock for services rendered | 22 | 22 | |||
Issuance of common stock for services rendered (in shares) | 2,000 | ||||
Stock-based compensation | 1,538 | 1,538 | |||
Net loss | (16,031) | (16,031) | |||
Ending balance at Jun. 30, 2018 | $ 27 | 725,659 | (640,620) | 85,066 | |
Ending balance (in shares) at Jun. 30, 2018 | 27,171,000 | ||||
Beginning balance at Dec. 31, 2018 | $ 27 | 728,342 | (664,375) | $ 63,994 | |
Beginning balance (in shares) at Dec. 31, 2018 | 27,188,000 | 27,188,000 | |||
Sale of common stock, net of issuance costs | $ 1 | 1,584 | $ 1,585 | ||
Sale of common stock, net of issuance costs (in shares) | 533,000 | ||||
Issuance of commitment shares (in shares) | 270,000 | ||||
Issuance of common stock under employee stock purchase plan | 26 | 26 | |||
Issuance of common stock under employee stock purchase plan (in shares) | 11,000 | ||||
Issuance of common stock for services rendered | 23 | 23 | |||
Issuance of common stock for services rendered (in shares) | 6,000 | ||||
Stock-based compensation | 1,016 | 1,016 | |||
Unrealized gain on marketable securities | $ 2 | 2 | |||
Net loss | (10,974) | (10,974) | |||
Ending balance at Mar. 31, 2019 | $ 28 | 730,991 | (675,349) | 2 | 55,672 |
Ending balance (in shares) at Mar. 31, 2019 | 28,008,000 | ||||
Beginning balance at Dec. 31, 2018 | $ 27 | 728,342 | (664,375) | $ 63,994 | |
Beginning balance (in shares) at Dec. 31, 2018 | 27,188,000 | 27,188,000 | |||
Sale of common stock, net of issuance costs (in shares) | 785,848 | ||||
Net loss | $ (22,150) | ||||
Ending balance at Jun. 30, 2019 | $ 29 | 734,229 | (686,525) | 2 | $ 47,735 |
Ending balance (in shares) at Jun. 30, 2019 | 28,827,000 | 28,827,000 | |||
Beginning balance at Mar. 31, 2019 | $ 28 | 730,991 | (675,349) | 2 | $ 55,672 |
Beginning balance (in shares) at Mar. 31, 2019 | 28,008,000 | ||||
Sale of common stock, net of issuance costs | $ 1 | 2,271 | 2,272 | ||
Sale of common stock, net of issuance costs (in shares) | 786,000 | ||||
Issuance of common stock under employee stock purchase plan | 42 | 42 | |||
Issuance of common stock under employee stock purchase plan (in shares) | 19,000 | ||||
Issuance of common stock for services rendered | 36 | 36 | |||
Issuance of common stock for services rendered (in shares) | 14,000 | ||||
Stock-based compensation | 889 | 889 | |||
Net loss | (11,176) | (11,176) | |||
Ending balance at Jun. 30, 2019 | $ 29 | $ 734,229 | $ (686,525) | $ 2 | $ 47,735 |
Ending balance (in shares) at Jun. 30, 2019 | 28,827,000 | 28,827,000 |
Business and Organization
Business and Organization | 6 Months Ended |
Jun. 30, 2019 | |
Business and Organization | |
Business and Organization | Note 1. Business and Organization Business Overview Idera Pharmaceuticals, Inc. (“Idera” or the “Company”), a Delaware corporation, is a clinical-stage biopharmaceutical company with a business strategy focused on the clinical development, and ultimately the commercialization, of drug candidates for both oncology and rare disease indications characterized by small, well defined patient populations with serious unmet medical needs. The Company’s current focus is on its Toll-like receptor, or TLR, agonist, tilsotolimod (IMO-2125), for oncology. The Company believes it can develop and commercialize targeted therapies on its own. To the extent the Company seeks to develop drug candidates for broader disease indications, it has entered into and may explore additional collaborative alliances to support development and commercialization. Liquidity and Financial Condition As of June 30, 2019, the Company had an accumulated deficit of $686.5 million and a cash, cash equivalents and short-term investments balance of $52.4 million. The Company expects to incur substantial operating losses in future periods and will require additional capital as it seeks to advance tilsotolimod and any future drug candidates through development to commercialization. The Company does not expect to generate product revenue, sales-based milestones or royalties until the Company successfully completes development of and obtains marketing approval for The Company believes, based on management’s current operating plan, that its existing balance of cash, cash equivalents and short-term investments on hand as of June 30, 2019 will be sufficient to fund operations into the second quarter of 2020. The C ompany follows the provisions of Financial Accounting Standards Board (“FASB”) Accounting Standards Codification (“ASC”) Topic 205-40, Presentation of Financial Statements—Going Concern , which requires management to assess the Company’s ability to continue as a going concern for one year after the date the financial statements are issued. The Company’s existing balance of cash, cash equivalents and short-term investments on hand as of June 30, 2019 is not sufficient to fund operations past the second quarter of 2020. While there is substantial doubt about the Company’s ability to continue as a going concern through the year period from the date these financial statements are issued, management’s plans to mitigate this risk include raising additional capital through the Company’s Common Stock Purchase Agreement (Note 7), “At-The-Market” Equity Program (Note 7), or additional financing or strategic transactions. Management’s plans may also include the possible deferral of certain operating expenses unless additional capital is received. Reverse Stock Split On July 27, 2018, the Company effected a 1-for-8 reverse stock split of the Company's outstanding shares of common stock, as authorized at a special meeting of stockholders on June 20, 2018. All share and per share amounts of common stock, options and warrants in the accompanying financial statements and notes thereto have been retroactively adjusted for all periods presented to reflect the reverse stock split. |
Summary of Significant Accounti
Summary of Significant Accounting Policies | 6 Months Ended |
Jun. 30, 2019 | |
Summary of Significant Accounting Policies | |
Summary of Significant Accounting Policies | Note 2. Summary of Significant Accounting Policies Basis of Presentation The accompanying unaudited financial statements included herein have been prepared by the Company in accordance with U.S. generally accepted accounting principles (“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 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 six months ended June 30, 2019 are not necessarily indicative of results that may be expected for the year ending December 31, 2019. 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, 2018 (the “2018 Form 10-K”), which was filed with the SEC on March 6, 2019. Reclassifications The prior year financial statements contain certain reclassifications to the results of operations for the three and six months ended June 30, 2018 to conform to the presentation for the year ended December 31, 2018 included in the 2018 Form 10-K. Merger-related costs of approximately $1.6 million and $5.1 million were reclassified from general and administrative expenses to merger-related costs, net for the three and six months ended June 30, 2018, respectively. 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 June 30, 2019 and December 31, 2018 consisted of cash, commercial paper and money market funds. 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 3. The Company is required to disclose the estimated fair values of its financial instruments. As of June 30, 2019 and December 31, 2018, the Company’s financial instruments consisted of cash, cash equivalents, investments and receivables and the estimated fair values of such financial instruments approximated their carrying values. As of June 30, 2019, the Company did not have any derivatives, hedging instruments or other similar financial instruments. Revenue Recognition In accordance with ASC Topic 606, Revenue from Contracts with Customers (“ASC 606”), the Company recognizes revenue when its customer obtains control of promised goods or services, in an amount that reflects the consideration which the entity expects to receive in exchange for those goods or services. The Company’s revenues have primarily been generated through collaborative research, development and/or commercialization agreements and other out-licensing arrangements. The terms of these agreements may include payment to the Company of one or more of the following: nonrefundable, up-front license fees; research, development and commercial milestone payments; and other contingent payments due based on the activities of the counterparty or the reimbursement by licensees of costs associated with patent maintenance. Each of these types of revenue are recorded as Alliance revenues in the Company’s statement of operations. See Note 9, “Collaboration and License Agreements” for additional details surrounding the Company’s collaboration arrangements. Note 2. Summary of Significant Accounting Policies (Continued) Income Taxes In accordance with ASC 270, Interim Reporting , and ASC 740, Income Taxes , the Company is required at the end of each interim period to determine the best estimate of its annual effective tax rate and then apply that rate in providing for income taxes on a current year-to-date (interim period) basis. For the three and six months ended June 30, 2019 and 2018, the Company recorded no tax expense or benefit due to the expected current year loss and its historical losses. The Company has not recorded its net deferred tax asset as of either June 30, 2019 or December 31, 2018 because it maintained a full valuation allowance against all deferred tax assets as of these dates as management has determined that it is not more likely than not that the Company will realize these future tax benefits. As of June 30, 2019 and December 31, 2018, the Company had no uncertain tax positions. New Accounting Pronouncements From time to time, new accounting pronouncements are issued by the FASB and rules are issued by the SEC that the Company has or will adopt as of a specified date. Unless otherwise noted, management does not believe that any other recently issued accounting pronouncements issued by the FASB or guidance issued by the SEC had, or is expected to have, a material impact on the Company’s present or future financial statements. Recently Adopted Accounting Pronouncements In February 2016, the FASB issued ASU No. 2016-02, Leases (Topic 842) (“ASU 2016-02”). ASU 2016-02 requires 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 GAAP, the recognition, measurement and presentation of expenses and cash flows arising from a lease by a lessee will depend primarily on its classification as a finance or operating lease. However, unlike the previous standard, which required only capital leases to be recognized on the balance sheet, ASU 2016-02 requires both types of leases to be recognized on the balance sheet. This guidance was applicable to the Company's fiscal year beginning January 1, 2019, and the Company adopted ASU 2016-02 in the first quarter of 2019 using the alternative modified retrospective transition method, which allowed the Company to apply the new lease standard to the beginning of the 2019 period and did not require adjusting comparative period financial information. Additionally, the Company elected the package of practical expedients to not reassess prior conclusions related to contracts containing leases, lease classification and initial direct costs. As a result of adopting ASU 2016-02, the primary impact on the Company’s financial statements was the recognition of a right-of-use asset and corresponding liability of approximately $0.3 million on its balance sheet as of January 1, 2019 related to its existing Exton, PA facility operating lease. In June 2018, the FASB issued ASU No. 2018-07, Compensation – Stock Compensation (Topic 718) (“ASU 2018-07”). ASU 2018-07 simplifies the accounting for nonemployee share-based payment transactions and was adopted by the Company in the first quarter of 2019. The adoption of this ASU did not have a material impact on the Company’s financial statements. |
Fair Value Measurements
Fair Value Measurements | 6 Months Ended |
Jun. 30, 2019 | |
Fair Value Measurements | |
Fair Value Measurements | Note 3. Fair Value Measurements Assets and Liabilities Measured at Fair Value on a Recurring Basis The Company applies the guidance in ASC 820, Fair Value Measurement , to account for financial assets and liabilities measured on a recurring basis. Fair value is measured 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. As such, fair value is a market-based measurement that is determined based on assumptions that market participants would use in pricing an asset or liability. The Company uses a fair value hierarchy, which distinguishes between assumptions based on market data (observable inputs) and an entity's own assumptions (unobservable inputs). The guidance requires that fair value measurements be classified and disclosed in one of the following three categories: · Level 1: Unadjusted quoted prices in active markets that are accessible at the measurement date for identical, unrestricted assets or liabilities; · Level 2: Quoted prices in markets that are not active or inputs which are observable, either directly or indirectly, for substantially the full term of the asset or liability; and · Level 3: Prices or valuation techniques that require inputs that are both significant to the fair value measurement and unobservable (i.e., supported by little or no market activity). Determining which category an asset or liability falls within the hierarchy requires significant judgment. The Company evaluates its hierarchy disclosures each reporting period. There were no transfers between Level 1, 2 and 3 during the six months ended June 30, 2019. The table below presents the assets and liabilities measured and recorded in the financial statements at fair value on a recurring basis at June 30, 2019 and December 31, 2018 categorized by the level of inputs used in the valuation of each asset and liability: June 30, 2019 (In thousands) Total Level 1 Level 2 Level 3 Assets Cash $ 250 $ 250 $ — $ — Money market funds 36,647 36,647 — — Other cash equivalents – commercial paper 2,987 — 2,987 — Short-term investments – commercial paper 3,496 — 3,496 — Short-term investments – U.S. treasury bills 8,993 8,993 — — Total assets $ 52,373 $ 45,890 $ 6,483 $ — Total liabilities $ — $ — $ — $ — December 31, 2018 (In thousands) Total Level 1 Level 2 Level 3 Assets Cash $ 8,446 $ 8,446 $ — $ — Money market funds 61,177 61,177 — — Other cash equivalents – commercial paper 1,808 — 1,808 — Total assets $ 71,431 $ 69,623 $ 1,808 $ — Total liabilities $ — $ — $ — $ — The Level 1 assets include money market funds, which are actively traded daily. |
Investments
Investments | 6 Months Ended |
Jun. 30, 2019 | |
Investments | |
Investments | Note 4. Investments The Company ’s available-for-sale investments at fair value consisted of the following at June 30, 2019: June 30, 2019 Gross Gross Estimated Unrealized Unrealized Fair (In thousands) Cost (Losses) Gains Value Short-term investments – commercial paper $ 3,496 $ — $ — $ 3,496 Short-term investments – U.S. treasury bills 8,991 — 2 8,993 Total short-term investments $ 12,487 $ — $ 2 $ 12,489 Total investments $ 12,487 $ — $ 2 $ 12,489 The Company had no realized gains or losses from the sale of investments in available-for-sale securities in each of the six months ended June 30, 2019 or 2018. There were no losses or other-than-temporary declines in value included in “Interest income” on the Company’s condensed statements of operations and comprehensive loss for any securities for the six months ended June 30, 2019 or 2018. |
Property and Equipment
Property and Equipment | 6 Months Ended |
Jun. 30, 2019 | |
Property and Equipment | |
Property and Equipment | Note 5. Property and Equipment At June 30, 2019 and December 31, 2018, property and equipment, net, consisted of the following: June 30, December 31, (In thousands) 2019 2018 Leasehold improvements $ 107 $ 104 Laboratory equipment and other 765 767 Total property and equipment, at cost 872 871 Less: Accumulated depreciation and amortization 721 664 Property and equipment, net $ 151 $ 207 Depreciation and amortization expense on property and equipment was approximately $0.1 million for each of the three months ended June 30, 2019 and 2018, and approximately $0.1 million and $0.3 million for the six months ended June 30, 2019 and 2018, respectively. There were no non-cash property additions during the six months ended June 30, 2019 or 2018. |
Accrued Expenses
Accrued Expenses | 6 Months Ended |
Jun. 30, 2019 | |
Accrued Expenses | |
Accrued Expenses | Note 6. Accrued Expenses At June 30, 2019 and December 31, 2018, accrued expenses consisted of the following: June 30, December 31, (In thousands) 2019 2018 Payroll and related costs $ 1,249 $ 1,962 Clinical and nonclinical trial expenses 3,681 3,958 Professional and consulting fees 446 605 Restructuring expenses 449 1,147 Other 114 212 Total accrued expenses $ 5,939 $ 7,884 Included in accrued Payroll and related costs as of June 30, 2019 and December 31, 2018 is $0.2 million and $0.7 million, respectively, of salary continuation severance benefits to be paid in equal installments through October 31, 2019 to former executives. |
Stockholders' Equity
Stockholders' Equity | 6 Months Ended |
Jun. 30, 2019 | |
Stockholders' Equity | |
Stockholders' Equity | Note 7. Stockholders’ Equity Equity Financings Common Stock Purchase Agreement On March 4, 2019, the Company entered into a Purchase Agreement with Lincoln Park Capital Fund, LLC (“Investor”), pursuant to which, upon the terms and subject to the conditions and limitations set forth therein, Investor has committed to purchase an aggregate of $35.0 million of shares of Company common stock from time to time at the Company’s sole discretion (the “Purchase Agreement”). As consideration for entering into the Purchase Agreement, the Company issued 269,749 shares of Company common stock to Investor as a commitment fee (the “Commitment Shares”). The closing price of the Company’s common stock on March 4, 2019 was $2.84 and the Company did not receive any cash proceeds from the issuance of the Commitment Shares. During the six months ended June 30, 2019, the Company sold 785,848 Shares pursuant to the Purchase Agreement, resulting in net proceeds of $2.3 million. "At-The-Market" Equity Program In November 2018, the Company entered into an Equity Distribution Agreement (the “ATM Agreement”) with JMP Securities LLC (“JMP”) pursuant to which the Company may issue and sell shares of its common stock having an aggregate offering price of up to $50.0 million (the “Shares”) through JMP as its agent. Subject to the terms and conditions of the Agreement, JMP will use its commercially reasonable efforts to sell the Shares from time to time, based upon the Company’s instructions, by methods deemed to be an “at the market offering” as defined in Rule 415(a)(4) promulgated under the Securities Act of 1933, as amended, or if specified by the Company, by any other method permitted by law, including but not limited to in negotiated transactions. The Company has no obligation to sell any of the Shares, and the Company or JMP may at any time suspend sales under the ATM Agreement or terminate the ATM Agreement. JMP is entitled to a fixed commission of 3.0% of the gross proceeds from Shares sold. During the six months ended June 30, 2019, the Company sold 532,700 Shares pursuant to the ATM Agreement resulting in net proceeds, after deduction of commissions and other offering expenses, of $1.6 million. Common Stock Warrants In connection with various financing transactions, the Company has issued warrants to purchase shares of the Company’s common stock. The Company accounts for common stock warrants as equity instruments, derivative liabilities or liabilities, depending on the specific terms of the warrant agreement. As of June 30, 2019 and December 31, 2018, all of the Company’s outstanding common stock warrants were equity-classified. The following table summarizes outstanding warrants to purchase shares of the Company’s common stock as of June 30, 2019 and December 31, 2018: Number of Shares June 30, December 31, Weighted-Average Description 2019 2018 Exercise Price Expiration Date Issued in May 2013 financing (pre-funded) 1,977,041 1,977,041 $ 0.08 May 2020 Issued in September 2013 financing (pre-funded) 521,997 521,997 $ 0.08 Sep 2020 Issued in February 2014 financing (pre-funded) 269,844 269,844 $ 0.08 Feb 2021 Total 2,768,882 2,768,882 The table below is a summary of the Company's warrant activity for the six months ended June 30, 2019: Number of Weighted-Average Warrants Exercise Price Outstanding at December 31, 2018 2,768,882 $ 0.08 Issued — — Exercised — — Expired — — Outstanding at June 30, 2019 2,768,882 $ 0.08 |
Alliance Revenue
Alliance Revenue | 6 Months Ended |
Jun. 30, 2019 | |
Alliance Revenue | |
Alliance Revenue | Note 8. Alliance Revenue Alliance revenue for the three and six months ended June 30, 2019 and 2018 represents revenue from contracts with customers accounted for in accordance with ASC Topic 606. For the three and six months ended June 30, 2019 and 2018, Alliance revenue in the accompanying statements of operations and comprehensive loss is comprised of the following: Three months ended Six months ended June 30, June 30, (In thousands) 2019 2018 2019 2018 Out-license arrangement (1) $ 1,447 $ — $ 1,447 $ — GSK collaboration (2) — 141 — 283 Vivelix collaboration (3) — — — 56 Other (4) 1 22 1 79 Total Alliance revenue $ 1,448 $ 163 $ 1,448 $ 418 (1) Revenue recognized in connection with the Licensee Agreement, as more fully described in Note 9. (2) Revenue recognized in connection with the GSK Agreement, as more fully described in Note 9. (3) Revenue recognized in connection with the Vivelix Agreement, as more fully described in Note 9. (4) For all periods presented, revenue recognized relates to collaborations which are not material to the Company’s current operations nor expected to be material in the future, including reimbursements by licensees of costs associated with patent maintenance. |
Collaboration and License Agree
Collaboration and License Agreements | 6 Months Ended |
Jun. 30, 2019 | |
Collaboration and License Agreements | |
Collaboration and License Agreements | Note 9. Collaboration and License Agreements Option and License Agreement with Licensee In April 2019, the Company entered into an amended and restated option and license agreement with a privately-held biopharmaceutical company (“Licensee”), pursuant to which the Company granted Licensee (i) exclusive worldwide rights to develop and market IMO-8400 for the treatment, palliation and diagnosis of all diseases, conditions or indications in humans (the “IMO-8400 License”), (ii) an exclusive right and license to develop IMO-9200 in accordance with certain IMO-9200 pre-option exercise protocols (the “IMO-9200 Option Period License”), and (iii) an exclusive option, exercisable at Licensee’s discretion, to obtain the exclusive worldwide rights to develop and market IMO-9200 for the treatment, palliation and diagnosis of all diseases, conditions or indications in humans (the “IMO-9200 Option”) (collectively, the “Licensee Agreement”). In connection with the Licensee Agreement, the Company transferred certain drug material to Licensee for Licensee’s use in development activities. Licensee is solely responsible for the development and commercialization of IMO-8400 and, if Licensee exercises the IMO-9200 Option, Licensee would be solely responsible for the development and commercialization of IMO-9200. Under the terms of the Licensee Agreement, the Company received upfront, non-refundable fees totaling approximately $1.4 million and was issued shares representing 10% of Licensee’s outstanding common stock, subject to future adjustment, for granting Licensee the IMO-8400 License, the IMO-9200 Option Period License and transfer of related drug materials. In addition, the Company is eligible to receive a $1 million non-refundable fee upon Licensee exercising the IMO-9200 Option (“Option Fee”) and is entitled to certain sub-licensing payments on sublicense revenue received by Licensee, if any. The Company may also be eligible for certain development and sales-based milestone payments and royalties on global net sales for any future products. The Company does not anticipate the receipt of any of the future milestones or royalties in the short term, if ever. Note 9. Collaboration and License Agreements (Continued) The Company concluded that the contract counterparty, Licensee, is a customer and accounted for the Licensee Agreement in accordance with ASC 606. As of June 30, 2019, the total transaction price of the contract was $1.4 million which excluded the Option Fee and all development and sales milestones as all such payments were fully constrained. Additionally, as of June 30, 2019, there were no remaining performance obligations under the Licensee Agreement. The Company re-evaluates its performance obligations and transaction price in each reporting period and as uncertain events are resolved or other changes in circumstances occur. As disclosed above, in connection with the Licensee Agreement, the Company was issued shares representing 10% of Licensee’s outstanding common stock, subject to future adjustment. The Company evaluated the guidance in ASC Topic 321, Investments-Equity Securities , and elected to account for the investment using the measurement alternative as the equity securities are without a readily determinable fair value, and the arrangement does not result in Idera having control or significant influence over Licensee. Accordingly, the securities are measured at cost, less any impairment, plus or minus changes resulting from observable price changes and are recorded in Other assets at a value of less than $0.1 million in the accompanying balance sheets. As of June 30, 2019, the Company considered the cost of the investment to not exceed the fair value of the investment and did not identify any observable price changes. For the three and six months ended June 30, 2019, the Company recognized Alliance revenues of $1.4 million under the Licensee Agreement, primarily related to the transfer of the IMO-8400 License and IMO-8400 drug product during the three months ended June 30, 2019. Collaboration with Vivelix In November 2016, the Company entered into an exclusive license and collaboration agreement with Vivelix pursuant to which the Company granted Vivelix worldwide rights to develop and market IMO-9200 for non-malignant gastrointestinal disorders, and certain back-up compounds to IMO-9200 (the “Vivelix Agreement”). The Company was previously developing IMO-9200 for potential use in selected autoimmune disease indications. However, the Company determined not to proceed with internal development of IMO-9200 because the large autoimmune disease indications for which IMO-9200 had been developed did not fit within the strategic focus of the Company. Under the terms of the Vivelix Agreement, Vivelix was solely responsible for the development and commercialization of IMO-9200 and any designated back-up compounds. In connection with the Vivelix Agreement, Idera also transferred certain drug material to Vivelix for Vivelix’s use in its development activities. Under the terms of the Vivelix Agreement, the Company received an upfront, non-refundable fee of $15 million and was eligible for future IMO-9200 related development, regulatory and sales milestone payments and sales-based royalties. However, on March 4, 2019, the Company and Vivelix mutually agreed to terminate the Vivelix Agreement. Accordingly, the Company is no longer eligible to receive any future milestone or royalty-based payments and all rights previously granted to Vivelix with respect to IMO-9200 and certain back-up compounds to IMO-9200 reverted back to the Company. For the three and six months ended June 30, 2018, the Company recognized Alliance revenues of less than $0.1 million related to certain research activities performed by the Company at Vivelix’s request, pursuant to the Vivelix Agreement. No such services were performed during the three and six months ended June 30, 2019. Collaboration with GSK In November 2015, the Company entered into a collaboration and license agreement with GSK to license, research, develop and commercialize pharmaceutical compounds from the Company’s nucleic acid chemistry technology for the treatment of selected targets in renal disease (the “GSK Agreement”). 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. 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. Note 9. Collaboration and License Agreements (Continued) The GSK Agreement also provided GSK with the option to select up to two additional targets at any time during the first two years of the GSK Agreement for further research under mutually agreed upon research plans. Upon selecting additional targets, GSK then had the option to 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. GSK did not select any additional targets for research through expiry of the option period. Under the terms of the GSK Agreement, the Company received a $2.5 million upfront, non-refundable, non-creditable cash payment upon the execution of the GSK Agreement. Additionally, the Company is eligible to receive an additional $18 million in license, research, clinical development and commercialization milestone payments, of which $1 million would be payable by GSK upon the designation of a development candidate from the initial target and $17 million would be payable by GSK upon the achievement of clinical milestones and commercial milestones. In addition, the Company is eligible to receive royalty payments on sales of licensed products following commercialization at varying rates of up to 5% on annual net sales, as defined in the GSK Agreement. For the three and six months ended June 30, 2018, the Company recognized Alliance revenues of $0.1 million and $0.3 million, respectively, related to the amortization of the deferred up-front payment received at inception of the GSK Agreement, over the 36-month anticipated performance period, which concluded in the fourth quarter of 2018. Accordingly, no such revenues were recognized during the three and six months ended June 30, 2019. |
Restructuring Costs
Restructuring Costs | 6 Months Ended |
Jun. 30, 2019 | |
Restructuring Costs | |
Restructuring Costs | Note 10. Restructuring Costs In July 2018, the Company determined to wind-down its discovery operations, reduce the workforce in Cambridge, Massachusetts that supports such operations, and close its Cambridge facility. In connection with the reduction-in-workforce, 18 positions were eliminated, primarily in the area of discovery, which represented approximately 40% of the Company’s employees. Of the 18 positions eliminated, 15 were effective July 31, 2018 with the remaining effective during the first half of 2019. Restructuring-related charges incurred, as of June 30, 2019, totaled $3.3 million and are comprised of (i) one-time termination costs in connection with the reduction in workforce, including severance, benefits and related costs, of approximately $2.8 million; (ii) contract termination costs of approximately $0.2 million in connection with the early lease termination for the Cambridge facility; and (iii) non-cash asset impairments of approximately $0.7 million, which includes $0.5 million of fixed asset impairments and $0.2 million in write-offs of facility-related prepaid expenses; offset by (iv) a non-cash gain of approximately $0.4 million related to the write-off of the remaining deferred rent liability associated with the Cambridge facility lease. The following summarizes restructuring-related activity for the six months ended June 30, 2019: (in thousands) Employee Severance Contract Termination Costs Asset Impairments Total Accrued restructuring balance as of December 31, 2018 $ 1,147 $ — $ — $ 1,147 Charges incurred 173 — — 173 Cash payments (859) — — (859) Accrued restructuring balance as of June 30, 2019 $ 461 $ — $ — $ 461 As of June 30, 2019, the short-term portion of the accrued restructuring balance, or $0.4 million, is included in “Accrued expenses” in the accompanying condensed balance sheets. See Note 6. The long-term portion of less than $0.1 million is included within “Other liabilities” in the accompanying condensed balance sheets. |
Stock-Based Compensation
Stock-Based Compensation | 6 Months Ended |
Jun. 30, 2019 | |
Stock-Based Compensation | |
Stock-Based Compensation | Note 11. Stock-Based Compensation As of June 30, 2019, the only equity compensation plans from which the Company may currently issue new awards are the Company’s 2013 Stock Incentive Plan Equity Incentive and Employee Stock Purchase Plans 2013 Stock Incentive Plan The Company's board of dire As of June 30, 2019, options to purchase a total of 2,992,630 shares of common stock and 193,625 restricted stock units were outstanding and up to 2,703,719 shares of common stock remained available for grant under the 2013 Plan. The Company has not made any awards pursuant to other equity incentive plans, including the 2008 Plan, since the Company’s stockholders approved the 2013 Plan. As of June 30, 2019, options to purchase a total of 457,997 shares of common stock were outstanding under the 2008 Plan. In addition, as of June 30, 2019, non-statutory stock options to purchase an aggregate of 393,750 shares of common stock were outstanding that were issued outside of the 2013 Plan to certain employees in 2017, 2015 and 2014 pursuant to the Nasdaq inducement grant exception as a material component of new hires’ employment compensation. 2017 Employee Stock Purchase Plan The Company’s board of directors adopted the 2017 ESPP, which was approved by the Company’s stockholders and became effective on June 7, 2017. An amendment to the 2017 ESPP was approved by the Company’s stockholders in June 2019. The 2017 ESPP provides for the issuance of up to 412,500 shares of common stock to participating employees of the Company or its subsidiaries. Participation is limited to employees that would not own 5% or more of the total combined voting power or value of the stock of the Company after the grant. As of June 30, 2019, 351,724 shares remained available for issuance under the 2017 ESPP. For the six months ended June 30, 2019 and 2018, the Company issued 30,570 and 13,112 shares of common stock, respectively, under the 2017 ESPP and received proceeds of less than $0.1 million during each period as a result of employee stock purchases. Accounting for Stock-based Compensation The Company recognizes non-cash compensation expense for stock-based awards under the Company’s equity incentive plans over an award’s requisite service period, or vesting period, using the straight-line attribution method, based on their grant date fair value determined using the Black-Scholes option-pricing model. The Company also recognizes non-cash compensation for stock purchases made under the 2017 ESPP. T he fair value of the discounted purchases made under the Company’s 2017 ESPP is calculated using the Black-Scholes option-pricing model. The fair value of the look-back provision plus the 15% discount is recognized as compensation expense over each plan period. Note 11. Stock-Based Compensation (Continued) Total stock-based compensation expense attributable to stock-based payments made to employees and directors and employee stock purchases included in operating expenses in the Company's statements of operations for the three and six months ended June 30, 2019 and 2018 was as follows: Three Months Ended Six Months Ended June 30, June 30, (in thousands) 2019 2018 2019 2018 Stock-based compensation: Research and development Employee Stock Purchase Plan $ 12 $ 29 $ 18 $ 51 Equity Incentive Plan 320 520 650 1,076 $ 332 $ 549 $ 668 $ 1,127 General and administrative Employee Stock Purchase Plan $ 8 $ 18 $ 14 $ 32 Equity Incentive Plan 549 971 1,223 1,968 $ 557 $ 989 $ 1,237 $ 2,000 Total stock-based compensation expense $ 889 $ 1,538 $ 1,905 $ 3,127 During the six months ended June 30, 2019 and 2018, the weighted average fair market value of stock options granted was $1.83 and $9.76, respectively. The following weighted average assumptions apply to the options to purchase 610,002 and 569,199 shares of common stock granted to employees and directors during the six months ended June 30, 2019 and 2018, respectively: Six Months Ended June 30, 2019 2018 Average risk-free interest rate Expected dividend yield — — Expected lives (years) 4.0 3.9 Expected volatility Weighted average exercise price (per share) $ 3.02 $ 17.42 All options granted during the six months ended June 30, 2019 and 2018 were granted at exercise prices equal to the fair market value of the common stock on the dates of grant . Stock Option Activity The following table summarizes stock option activity for the six months ended June 30, 2019: ($ in thousands, except per share data) Stock Weighted-Average Weighted-Average Aggregate Intrinsic Value Outstanding at December 31, 2018 3,304,531 $ 18.42 6.6 $ — Granted 610,002 3.02 Exercised — — Forfeited (60,595) 13.36 Expired (9,561) 40.42 Outstanding at June 30, 2019 (1) 3,844,377 $ 15.99 6.6 $ 9 Exercisable at June 30, 2019 2,217,289 $ 21.36 4.9 $ — (1) Includes both vested stock options as well as unvested stock options for which the requisite service period has not been rendered but that are expected to vest based on achievement of a service condition. Note 11. Stock-Based Compensation (Continued) The fair value of options that vested during the six months ended June 30, 2019 was $2.5 million. As of June 30, 2019, there was $6.2 million of unrecognized compensation cost related to unvested options, which the Company expects to recognize over a weighted average period of 2.5 years. Restricted Stock Activity The following table summarizes restricted stock activity for the six months ended June 30, 2019: ($ in thousands, except per share data) Number of Shares Weighted-Average Nonvested shares at December 31, 2018 — $ — Granted 194,550 3.14 Cancelled (925) 3.14 Vested — — Nonvested shares at June 30, 2019 193,625 $ 3.14 As of June 30, 2019, there was $0.5 million of unrecognized compensation expense related to the restricted stock units, which is expected to be recognized over a weighted-average period of 3.5 years. |
Related Party Transactions
Related Party Transactions | 6 Months Ended |
Jun. 30, 2019 | |
Related Party Transactions | |
Related Party Transactions | Note 12. Related Party Transactions Overview of Related Parties Julian C. Baker, a member of the Company’s Board until his resignation in September 2018, is a principal of Baker Bros. Advisors, LP. Baker Bros. Advisors, LP and certain of its affiliated funds (collectively, “Baker Brothers”) owned approximately 16% of the Company's common stock as of June 30, 2019. Additionally, Kelvin M. Neu, a member of Company’s Board until his resignation in June 2019, is an employee of Baker Bros. Advisors, LP. During the six months ended June 30, 2019, Baker Brothers made an in-kind pro rata distribution of a total of 60,070 warrants to Mr. Baker, Mr. Neu and other investors in Baker Brothers. During the six months ended June 30, 2018, Baker Brothers exercised warrants to purchase 2,539,541 shares of the Company’s common stock at an exercise price of $3.76 per share for a total exercise price of approximately $9.5 million. As of June 30, 2019, Baker Brothers held pre-funded warrants to purchase up to 2,708,812 shares of the Company’s common stock at an exercise price of $0.08 per share. Board Fees Paid in Stock Pursuant to the Company’s director compensation program, in lieu of director board and committee fees incurred of $0.1 million during each of the six months ended June 30, 2019 and 2018, the Company issued 26,331 and 4,727 shares of its common stock, respectively, to certain of its directors. Director board and committee fees are paid in arrears (including fees paid in stock) and the number of shares issued was calculated based on the market closing price of the Company’s common stock on the issuance date. |
Net Loss per Common Share
Net Loss per Common Share | 6 Months Ended |
Jun. 30, 2019 | |
Net Loss per Common Share | |
Net Loss per Common Share | Note 13. Net Loss per Common Share Basic and diluted net loss per common share applicable to common stockholders is calculated by dividing net loss applicable to common stockholders by the weighted-average number of shares of common stock outstanding during the period, without consideration of common stock equivalents. The Company’s potentially dilutive shares, which include outstanding stock option awards, common stock warrants and convertible preferred stock, are considered to be common stock equivalents and are only included in the calculation of diluted net loss per share when their effect is dilutive. For the three and six months ended June 30, 2019 and 2018, diluted net loss per common share applicable to common stockholders was the same as basic net loss per common share applicable to common stockholders as the effects of the Company’s potential common stock equivalents are antidilutive. Total antidilutive securities excluded from the calculation of diluted net loss per share were 6,808,810 and 5,725,883 as of June 30, 2019 and 2018, respectively, and consisted of stock options, preferred stock and warrants. |
Subsequent Events
Subsequent Events | 6 Months Ended |
Jun. 30, 2019 | |
Subsequent Events. | |
Subsequent Events | Note 14. Subsequent Events The Company considers events or transactions that occur after the balance sheet date but prior to the issuance of the financial statements to provide additional evidence relative to certain estimates or to identify matters that require additional disclosure. |
Summary of Significant Accoun_2
Summary of Significant Accounting Policies (Policies) | 6 Months Ended |
Jun. 30, 2019 | |
Summary of Significant Accounting Policies | |
Basis of Presentation | Basis of Presentation The accompanying unaudited financial statements included herein have been prepared by the Company in accordance with U.S. generally accepted accounting principles (“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 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 six months ended June 30, 2019 are not necessarily indicative of results that may be expected for the year ending December 31, 2019. 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, 2018 (the “2018 Form 10-K”), which was filed with the SEC on March 6, 2019. |
Reclassifications | Reclassifications The prior year financial statements contain certain reclassifications to the results of operations for the three and six months ended June 30, 2018 to conform to the presentation for the year ended December 31, 2018 included in the 2018 Form 10-K. Merger-related costs of approximately $1.6 million and $5.1 million were reclassified from general and administrative expenses to merger-related costs, net for the three and six months ended June 30, 2018, respectively. |
Cash and Cash Equivalents | 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 June 30, 2019 and December 31, 2018 consisted of cash, commercial paper and money market funds. |
Financial Instruments | 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 3. The Company is required to disclose the estimated fair values of its financial instruments. As of June 30, 2019 and December 31, 2018, the Company’s financial instruments consisted of cash, cash equivalents, investments and receivables and the estimated fair values of such financial instruments approximated their carrying values. As of June 30, 2019, the Company did not have any derivatives, hedging instruments or other similar financial instruments. |
Revenue Recognition | Revenue Recognition In accordance with ASC Topic 606, Revenue from Contracts with Customers (“ASC 606”), the Company recognizes revenue when its customer obtains control of promised goods or services, in an amount that reflects the consideration which the entity expects to receive in exchange for those goods or services. The Company’s revenues have primarily been generated through collaborative research, development and/or commercialization agreements and other out-licensing arrangements. The terms of these agreements may include payment to the Company of one or more of the following: nonrefundable, up-front license fees; research, development and commercial milestone payments; and other contingent payments due based on the activities of the counterparty or the reimbursement by licensees of costs associated with patent maintenance. Each of these types of revenue are recorded as Alliance revenues in the Company’s statement of operations. See Note 9, “Collaboration and License Agreements” for additional details surrounding the Company’s collaboration arrangements. |
Income Taxes | Income Taxes In accordance with ASC 270, Interim Reporting , and ASC 740, Income Taxes , the Company is required at the end of each interim period to determine the best estimate of its annual effective tax rate and then apply that rate in providing for income taxes on a current year-to-date (interim period) basis. For the three and six months ended June 30, 2019 and 2018, the Company recorded no tax expense or benefit due to the expected current year loss and its historical losses. The Company has not recorded its net deferred tax asset as of either June 30, 2019 or December 31, 2018 because it maintained a full valuation allowance against all deferred tax assets as of these dates as management has determined that it is not more likely than not that the Company will realize these future tax benefits. As of June 30, 2019 and December 31, 2018, the Company had no uncertain tax positions. |
New Accounting Pronouncements | New Accounting Pronouncements From time to time, new accounting pronouncements are issued by the FASB and rules are issued by the SEC that the Company has or will adopt as of a specified date. Unless otherwise noted, management does not believe that any other recently issued accounting pronouncements issued by the FASB or guidance issued by the SEC had, or is expected to have, a material impact on the Company’s present or future financial statements. Recently Adopted Accounting Pronouncements In February 2016, the FASB issued ASU No. 2016-02, Leases (Topic 842) (“ASU 2016-02”). ASU 2016-02 requires 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 GAAP, the recognition, measurement and presentation of expenses and cash flows arising from a lease by a lessee will depend primarily on its classification as a finance or operating lease. However, unlike the previous standard, which required only capital leases to be recognized on the balance sheet, ASU 2016-02 requires both types of leases to be recognized on the balance sheet. This guidance was applicable to the Company's fiscal year beginning January 1, 2019, and the Company adopted ASU 2016-02 in the first quarter of 2019 using the alternative modified retrospective transition method, which allowed the Company to apply the new lease standard to the beginning of the 2019 period and did not require adjusting comparative period financial information. Additionally, the Company elected the package of practical expedients to not reassess prior conclusions related to contracts containing leases, lease classification and initial direct costs. As a result of adopting ASU 2016-02, the primary impact on the Company’s financial statements was the recognition of a right-of-use asset and corresponding liability of approximately $0.3 million on its balance sheet as of January 1, 2019 related to its existing Exton, PA facility operating lease. In June 2018, the FASB issued ASU No. 2018-07, Compensation – Stock Compensation (Topic 718) (“ASU 2018-07”). ASU 2018-07 simplifies the accounting for nonemployee share-based payment transactions and was adopted by the Company in the first quarter of 2019. The adoption of this ASU did not have a material impact on the Company’s financial statements. |
Fair Value Measurements (Tables
Fair Value Measurements (Tables) | 6 Months Ended |
Jun. 30, 2019 | |
Fair Value Measurements | |
Schedule of assets and liabilities measured and recorded in financial statements at fair value on a recurring basis | June 30, 2019 (In thousands) Total Level 1 Level 2 Level 3 Assets Cash $ 250 $ 250 $ — $ — Money market funds 36,647 36,647 — — Other cash equivalents – commercial paper 2,987 — 2,987 — Short-term investments – commercial paper 3,496 — 3,496 — Short-term investments – U.S. treasury bills 8,993 8,993 — — Total assets $ 52,373 $ 45,890 $ 6,483 $ — Total liabilities $ — $ — $ — $ — December 31, 2018 (In thousands) Total Level 1 Level 2 Level 3 Assets Cash $ 8,446 $ 8,446 $ — $ — Money market funds 61,177 61,177 — — Other cash equivalents – commercial paper 1,808 — 1,808 — Total assets $ 71,431 $ 69,623 $ 1,808 $ — Total liabilities $ — $ — $ — $ — |
Investments (Tables)
Investments (Tables) | 6 Months Ended |
Jun. 30, 2019 | |
Investments | |
Schedule of available-for-sale investments at fair value | June 30, 2019 Gross Gross Estimated Unrealized Unrealized Fair (In thousands) Cost (Losses) Gains Value Short-term investments – commercial paper $ 3,496 $ — $ — $ 3,496 Short-term investments – U.S. treasury bills 8,991 — 2 8,993 Total short-term investments $ 12,487 $ — $ 2 $ 12,489 Total investments $ 12,487 $ — $ 2 $ 12,489 |
Property and Equipment (Tables)
Property and Equipment (Tables) | 6 Months Ended |
Jun. 30, 2019 | |
Property and Equipment | |
Schedule of net property and equipment at cost | June 30, December 31, (In thousands) 2019 2018 Leasehold improvements $ 107 $ 104 Laboratory equipment and other 765 767 Total property and equipment, at cost 872 871 Less: Accumulated depreciation and amortization 721 664 Property and equipment, net $ 151 $ 207 |
Accrued Expenses (Tables)
Accrued Expenses (Tables) | 6 Months Ended |
Jun. 30, 2019 | |
Accrued Expenses | |
Schedule of accrued expenses | June 30, December 31, (In thousands) 2019 2018 Payroll and related costs $ 1,249 $ 1,962 Clinical and nonclinical trial expenses 3,681 3,958 Professional and consulting fees 446 605 Restructuring expenses 449 1,147 Other 114 212 Total accrued expenses $ 5,939 $ 7,884 |
Stockholders' Equity (Tables)
Stockholders' Equity (Tables) | 6 Months Ended |
Jun. 30, 2019 | |
Stockholders' Equity | |
Schedule of warrants outstanding and exercisable for purchase of common stock | Number of Shares June 30, December 31, Weighted-Average Description 2019 2018 Exercise Price Expiration Date Issued in May 2013 financing (pre-funded) 1,977,041 1,977,041 $ 0.08 May 2020 Issued in September 2013 financing (pre-funded) 521,997 521,997 $ 0.08 Sep 2020 Issued in February 2014 financing (pre-funded) 269,844 269,844 $ 0.08 Feb 2021 Total 2,768,882 2,768,882 |
Summary of warrant activity | Number of Weighted-Average Warrants Exercise Price Outstanding at December 31, 2018 2,768,882 $ 0.08 Issued — — Exercised — — Expired — — Outstanding at June 30, 2019 2,768,882 $ 0.08 |
Alliance Revenue (Tables)
Alliance Revenue (Tables) | 6 Months Ended |
Jun. 30, 2019 | |
Alliance Revenue | |
Schedule of accompanying statements of operations and comprehensive loss | Three months ended Six months ended June 30, June 30, (In thousands) 2019 2018 2019 2018 Out-license arrangement (1) $ 1,447 $ — $ 1,447 $ — GSK collaboration (2) — 141 — 283 Vivelix collaboration (3) — — — 56 Other (4) 1 22 1 79 Total Alliance revenue $ 1,448 $ 163 $ 1,448 $ 418 (1) Revenue recognized in connection with the Licensee Agreement, as more fully described in Note 9. (2) Revenue recognized in connection with the GSK Agreement, as more fully described in Note 9. (3) Revenue recognized in connection with the Vivelix Agreement, as more fully described in Note 9. For all periods presented, revenue recognized relates to collaborations which are not material to the Company’s current operations nor expected to be material in the future, including reimbursements by licensees of costs associated with patent maintenance. |
Restructuring Costs (Tables)
Restructuring Costs (Tables) | 6 Months Ended |
Jun. 30, 2019 | |
Restructuring Costs | |
Schedule of restructuring costs | (in thousands) Employee Severance Contract Termination Costs Asset Impairments Total Accrued restructuring balance as of December 31, 2018 $ 1,147 $ — $ — $ 1,147 Charges incurred 173 — — 173 Cash payments (859) — — (859) Accrued restructuring balance as of June 30, 2019 $ 461 $ — $ — $ 461 |
Stock-Based Compensation (Table
Stock-Based Compensation (Tables) | 6 Months Ended |
Jun. 30, 2019 | |
Stock-Based Compensation | |
Schedule of stock-based compensation expense attributable to share-based payments made to employees and directors and included in operating expenses | Three Months Ended Six Months Ended June 30, June 30, (in thousands) 2019 2018 2019 2018 Stock-based compensation: Research and development Employee Stock Purchase Plan $ 12 $ 29 $ 18 $ 51 Equity Incentive Plan 320 520 650 1,076 $ 332 $ 549 $ 668 $ 1,127 General and administrative Employee Stock Purchase Plan $ 8 $ 18 $ 14 $ 32 Equity Incentive Plan 549 971 1,223 1,968 $ 557 $ 989 $ 1,237 $ 2,000 Total stock-based compensation expense $ 889 $ 1,538 $ 1,905 $ 3,127 |
Schedule of weighted average assumptions applied to options | Six Months Ended June 30, 2019 2018 Average risk-free interest rate Expected dividend yield — — Expected lives (years) 4.0 3.9 Expected volatility Weighted average exercise price (per share) $ 3.02 $ 17.42 |
Schedule of information related to outstanding and exercisable options | ($ in thousands, except per share data) Stock Weighted-Average Weighted-Average Aggregate Intrinsic Value Outstanding at December 31, 2018 3,304,531 $ 18.42 6.6 $ — Granted 610,002 3.02 Exercised — — Forfeited (60,595) 13.36 Expired (9,561) 40.42 Outstanding at June 30, 2019 (1) 3,844,377 $ 15.99 6.6 $ 9 Exercisable at June 30, 2019 2,217,289 $ 21.36 4.9 $ — (1) Includes both vested stock options as well as unvested stock options for which the requisite service period has not been rendered but that are expected to vest based on achievement of a service condition. |
Schedule of summary of restricted stock activity | ($ in thousands, except per share data) Number of Shares Weighted-Average Nonvested shares at December 31, 2018 — $ — Granted 194,550 3.14 Cancelled (925) 3.14 Vested — — Nonvested shares at June 30, 2019 193,625 $ 3.14 |
Business and Organization (Deta
Business and Organization (Details) $ in Thousands | Jul. 27, 2018 | Jun. 30, 2019USD ($) | Dec. 31, 2018USD ($) |
Business and Organization | |||
Accumulated deficit | $ 686,525 | $ 664,375 | |
Cash, cash equivalents and investments | $ 52,400 | ||
Reverse stock split conversion ratio | 0.125 |
Summary of Significant Accoun_3
Summary of Significant Accounting Policies - Additional Information (Details) - USD ($) $ in Thousands | 3 Months Ended | 6 Months Ended | 12 Months Ended | ||
Jun. 30, 2019 | Jun. 30, 2018 | Jun. 30, 2019 | Jun. 30, 2018 | Dec. 31, 2018 | |
Summary of Significant Accounting Policies | |||||
Reclassification adjustment | $ 1,600 | $ 1,600 | $ 5,100 | ||
Tax expense (benefit) | $ 0 | $ 0 | $ 0 | $ 0 | |
Uncertain tax positions | $ 0 | $ 0 | $ 0 |
Summary of Significant Accoun_4
Summary of Significant Accounting Policies - New Accounting Pronouncements (Details) - USD ($) $ in Thousands | Jan. 01, 2019 | Feb. 29, 2016 | Jun. 30, 2019 |
New Accounting Pronouncements or Change in Accounting Principle | |||
Lease, Practical Expedients, Package [true false] | true | ||
Operating lease right-of-use asset | $ 300 | $ 171 | |
Operating lease liability | $ 300 | ||
Minimum | |||
New Accounting Pronouncements or Change in Accounting Principle | |||
Lease term | 12 months |
Fair Value Measurements - Trans
Fair Value Measurements - Transfers Between Levels (Details) $ in Thousands | 6 Months Ended |
Jun. 30, 2019USD ($) | |
Fair Value Measurements | |
Fair value of assets transfers from level 1 to level 2 | $ 0 |
Fair value of assets transfers from level 2 to level 1 | 0 |
Fair value of liabilities transfers from level 1 to level 2 | 0 |
Fair value of liabilities transfers from level 2 to level 1 | 0 |
Fair value of assets transfers into level 3 | 0 |
Fair value of assets transfers out of level 3 | 0 |
Fair value of liabilities transfers into level 3 | 0 |
Fair value of liabilities transfers out of level 3 | $ 0 |
Fair Value Measurements - Asset
Fair Value Measurements - Assets and Liabilities at Fair Value on Recurring Basis (Details) - USD ($) $ in Thousands | Jun. 30, 2019 | Dec. 31, 2018 |
Fair Value of Assets and Liabilities Measured at Fair Value on a Recurring Basis | ||
Other cash equivalents and Short-term investments | $ 12,489 | |
Fair value on a recurring basis | ||
Fair Value of Assets and Liabilities Measured at Fair Value on a Recurring Basis | ||
Total Assets | 52,373 | $ 71,431 |
Fair value on a recurring basis | Cash | ||
Fair Value of Assets and Liabilities Measured at Fair Value on a Recurring Basis | ||
Cash and Money market funds | 250 | |
Other cash equivalents and Short-term investments | 8,446 | |
Fair value on a recurring basis | Money market funds | ||
Fair Value of Assets and Liabilities Measured at Fair Value on a Recurring Basis | ||
Cash and Money market funds | 36,647 | 61,177 |
Fair value on a recurring basis | Other cash equivalents – commercial paper | ||
Fair Value of Assets and Liabilities Measured at Fair Value on a Recurring Basis | ||
Other cash equivalents and Short-term investments | 2,987 | 1,808 |
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 | ||
Other cash equivalents and Short-term investments | 3,496 | |
Fair value on a recurring basis | Short-term investments – U.S. treasury bills | ||
Fair Value of Assets and Liabilities Measured at Fair Value on a Recurring Basis | ||
Other cash equivalents and Short-term investments | 8,993 | |
Quoted Prices in Active Markets for Identical Assets or Liabilities (Level 1) | Fair value on a recurring basis | ||
Fair Value of Assets and Liabilities Measured at Fair Value on a Recurring Basis | ||
Total Assets | 45,890 | 69,623 |
Quoted Prices in Active Markets for Identical Assets or Liabilities (Level 1) | Fair value on a recurring basis | Cash | ||
Fair Value of Assets and Liabilities Measured at Fair Value on a Recurring Basis | ||
Cash and Money market funds | 250 | |
Other cash equivalents and Short-term investments | 8,446 | |
Quoted Prices in Active Markets for Identical Assets or Liabilities (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 | ||
Cash and Money market funds | 36,647 | 61,177 |
Quoted Prices in Active Markets for Identical Assets or Liabilities (Level 1) | Fair value on a recurring basis | Short-term investments – U.S. treasury bills | ||
Fair Value of Assets and Liabilities Measured at Fair Value on a Recurring Basis | ||
Other cash equivalents and Short-term investments | 8,993 | |
Significant Other Observable Inputs (Level 2) | Fair value on a recurring basis | ||
Fair Value of Assets and Liabilities Measured at Fair Value on a Recurring Basis | ||
Total Assets | 6,483 | 1,808 |
Significant Other Observable Inputs (Level 2) | Fair value on a recurring basis | Other cash equivalents – commercial paper | ||
Fair Value of Assets and Liabilities Measured at Fair Value on a Recurring Basis | ||
Other cash equivalents and Short-term investments | 2,987 | $ 1,808 |
Significant Other Observable Inputs (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 | ||
Other cash equivalents and Short-term investments | $ 3,496 |
Investments - Summary of Availa
Investments - Summary of Available-for-Sale Investments at Fair Value (Details) $ in Thousands | Jun. 30, 2019USD ($) |
Schedule of Available-for-sale Securities | |
Cost | $ 12,487 |
Gross Unrealized Gains | 2 |
Estimated Fair Value | 12,489 |
Short-term investments | |
Schedule of Available-for-sale Securities | |
Cost | 12,487 |
Gross Unrealized Gains | 2 |
Estimated Fair Value | 12,489 |
Short-term investments – commercial paper | |
Schedule of Available-for-sale Securities | |
Cost | 3,496 |
Estimated Fair Value | 3,496 |
Short-term investments – U.S. treasury bills | |
Schedule of Available-for-sale Securities | |
Cost | 8,991 |
Gross Unrealized Gains | 2 |
Estimated Fair Value | $ 8,993 |
Investments - Additional Inform
Investments - Additional Information (Details) - USD ($) | 6 Months Ended | |
Jun. 30, 2019 | Jun. 30, 2018 | |
Investments | ||
Realized gains or losses | $ 0 | $ 0 |
Losses or other-than-temporary declines | $ 0 | $ 0 |
Property and Equipment - Net Pr
Property and Equipment - Net Property and Equipment at Cost (Details) - USD ($) $ in Thousands | Jun. 30, 2019 | Dec. 31, 2018 |
Property, Plant and Equipment | ||
Total property and equipment, at cost | $ 872 | $ 871 |
Less: accumulated depreciation and amortization | 721 | 664 |
Property and equipment, net | 151 | 207 |
Leasehold improvements | ||
Property, Plant and Equipment | ||
Total property and equipment, at cost | 107 | 104 |
Laboratory equipment and other | ||
Property, Plant and Equipment | ||
Total property and equipment, at cost | $ 765 | $ 767 |
Property and Equipment - Deprec
Property and Equipment - Depreciation and Amortization Expense (Details) - USD ($) $ in Thousands | 3 Months Ended | 6 Months Ended | ||
Jun. 30, 2019 | Jun. 30, 2018 | Jun. 30, 2019 | Jun. 30, 2018 | |
Property and Equipment | ||||
Depreciation and amortization expense on property and equipment | $ 100 | $ 100 | $ 100 | $ 300 |
Non-cash property additions | $ 0 | $ 0 |
Accrued Expenses (Details)
Accrued Expenses (Details) - USD ($) $ in Thousands | Jun. 30, 2019 | Dec. 31, 2018 |
Accrued Expenses | ||
Payroll and related costs | $ 1,249 | $ 1,962 |
Clinical and nonclinical trial expenses | 3,681 | 3,958 |
Professional and consulting fees | 446 | 605 |
Restructuring expenses | 449 | 1,147 |
Other | 114 | 212 |
Total accrued expenses | 5,939 | 7,884 |
Salary continuation severance benefits | $ 200 | $ 700 |
Stockholders' Equity - Common S
Stockholders' Equity - Common Stock (Details) - USD ($) $ / shares in Units, $ in Millions | Mar. 04, 2019 | Nov. 30, 2018 | Jun. 30, 2019 | Mar. 31, 2019 | Jun. 30, 2019 |
Class of Stock | |||||
Stock issued (in shares) | 785,848 | ||||
Net proceeds from offering of common stock | $ 2.3 | ||||
"At-The-Market" Equity Program | |||||
Class of Stock | |||||
Stock issued (in shares) | 532,700 | ||||
Net proceeds from offering of common stock | $ 1.6 | ||||
Percentage of fixed commission expense of gross proceeds of shares sold in ATM agreement | 3.00% | ||||
Lincoln Park Capital Fund, LLC (“Investor”) | |||||
Class of Stock | |||||
Value of shares investor has committed to purchase from time to time at Company’s sole discretion | $ 35 | ||||
Stock issued (in shares) | 269,749 | ||||
Stock issued (per share) | $ 2.84 | ||||
Common Stock | |||||
Class of Stock | |||||
Stock issued (in shares) | 786,000 | 533,000 | |||
Common Stock | "At-The-Market" Equity Program | |||||
Class of Stock | |||||
Net proceeds from offering of common stock | $ 50 |
Stockholders' Equity - Common_2
Stockholders' Equity - Common Stock Warrants (Details) - $ / shares | Jun. 30, 2019 | Dec. 31, 2018 |
Class of Warrant or Right | ||
Number of Warrants | 2,768,882 | 2,768,882 |
Warrant exercise price per share | $ 0.08 | $ 0.08 |
Expiration Date - May 2020 | ||
Class of Warrant or Right | ||
Number of Warrants | 1,977,041 | 1,977,041 |
Warrant exercise price per share | $ 0.08 | |
Expiration Date - September 2020 | ||
Class of Warrant or Right | ||
Number of Warrants | 521,997 | 521,997 |
Warrant exercise price per share | $ 0.08 | |
Expiration Date - February 2021 | ||
Class of Warrant or Right | ||
Number of Warrants | 269,844 | 269,844 |
Warrant exercise price per share | $ 0.08 |
Stockholders' Equity - Common_3
Stockholders' Equity - Common Stock Warrant Activity (Details) - $ / shares | Jun. 30, 2019 | Dec. 31, 2018 |
Stockholders' Equity | ||
Warrant exercise price per share | $ 0.08 | $ 0.08 |
Alliance Revenue (Details)
Alliance Revenue (Details) - USD ($) $ in Thousands | 3 Months Ended | 6 Months Ended | ||
Jun. 30, 2019 | Jun. 30, 2018 | Jun. 30, 2019 | Jun. 30, 2018 | |
Alliance Revenue | ||||
Alliance revenue | $ 1,448 | $ 163 | $ 1,448 | $ 418 |
Out-license arrangement (1) | ||||
Alliance Revenue | ||||
Alliance revenue | 1,447 | 1,447 | ||
Gsk Collaboration | ||||
Alliance Revenue | ||||
Alliance revenue | 141 | 283 | ||
Vivelix Collaboration | ||||
Alliance Revenue | ||||
Alliance revenue | 56 | |||
Other | ||||
Alliance Revenue | ||||
Alliance revenue | $ 1 | $ 22 | $ 1 | $ 79 |
Collaboration and License Agr_2
Collaboration and License Agreements (Details) | 1 Months Ended | 3 Months Ended | 6 Months Ended | ||||
Apr. 30, 2019USD ($) | Nov. 30, 2016USD ($) | Nov. 30, 2015USD ($)person | Jun. 30, 2019USD ($) | Jun. 30, 2018USD ($) | Jun. 30, 2019USD ($) | Jun. 30, 2018USD ($) | |
Collaborative Arrangements and Non-collaborative Arrangement Transactions | |||||||
Alliance revenue | $ 1,448,000 | $ 163,000 | $ 1,448,000 | $ 418,000 | |||
Option and License Agreement with Licensee | |||||||
Collaborative Arrangements and Non-collaborative Arrangement Transactions | |||||||
Alliance revenue | 1,400,000 | 1,400,000 | |||||
Transaction price | 1,400,000 | ||||||
Performance obligation | 0 | $ 0 | |||||
Percentage of shares acquired | 10.00% | 10.00% | |||||
Option and License Agreement with Licensee | Other Assets | |||||||
Collaborative Arrangements and Non-collaborative Arrangement Transactions | |||||||
Equity Securities without Readily Determinable Fair Value, Amount | 100,000 | $ 100,000 | |||||
Vivelix | |||||||
Collaborative Arrangements and Non-collaborative Arrangement Transactions | |||||||
Alliance revenue | 0 | 0 | |||||
Vivelix | Up-front Payment Arrangement | |||||||
Collaborative Arrangements and Non-collaborative Arrangement Transactions | |||||||
Upfront payment received under collaboration agreement | $ 15,000,000 | ||||||
Vivelix | Maximum | |||||||
Collaborative Arrangements and Non-collaborative Arrangement Transactions | |||||||
Alliance revenue | 100,000 | 100,000 | |||||
GSK Agreement | |||||||
Collaborative Arrangements and Non-collaborative Arrangement Transactions | |||||||
Number of development candidates | person | 1 | ||||||
Number of optional additional targets | person | 2 | ||||||
Deferred revenue recognized during the period | $ 0 | $ 100,000 | $ 0 | $ 300,000 | |||
Research period | 2 years | 36 months | |||||
GSK Agreement | Up-front Payment Arrangement | |||||||
Collaborative Arrangements and Non-collaborative Arrangement Transactions | |||||||
Upfront payment received under collaboration agreement | $ 2,500,000 | ||||||
GSK Agreement | License, Research, Clinical Development and Commercialization | |||||||
Collaborative Arrangements and Non-collaborative Arrangement Transactions | |||||||
Milestone payments | $ 18,000,000 | ||||||
GSK Agreement | Research and Development Plans and Designation of Development Candidates | |||||||
Collaborative Arrangements and Non-collaborative Arrangement Transactions | |||||||
Milestone payments | 1,000,000 | ||||||
GSK Agreement | Clinical and Commercial Milestones | |||||||
Collaborative Arrangements and Non-collaborative Arrangement Transactions | |||||||
Milestone payments | $ 17,000,000 | ||||||
GSK Agreement | Maximum | |||||||
Collaborative Arrangements and Non-collaborative Arrangement Transactions | |||||||
Maximum royalty percentage on net sales | 5.00% | ||||||
IMO-9200 License | Option and License Agreement with Licensee | |||||||
Collaborative Arrangements and Non-collaborative Arrangement Transactions | |||||||
Upfront payment received under collaboration agreement | $ 1,400,000 | ||||||
Non-refundable fee upon exercise of option | $ 1,000,000 |
Restructuring Costs (Details)
Restructuring Costs (Details) $ in Thousands | 1 Months Ended | 3 Months Ended | 6 Months Ended | 12 Months Ended | |
Jul. 31, 2018employee | Jun. 30, 2019USD ($) | Jun. 30, 2019USD ($) | Jun. 30, 2019USD ($) | Dec. 31, 2018USD ($) | |
Restructuring costs | |||||
Restructuring costs | $ 45 | $ 176 | |||
Long-term portion of restructuring accrual | $ 12 | 12 | $ 12 | $ 11 | |
Cambridge, Massachusetts facility operations | |||||
Restructuring costs | |||||
Number of positions eliminated | employee | 18 | ||||
Percentage of positions eliminated | 40.00% | ||||
Number of positions eliminated since inception | employee | 15 | ||||
Restructuring costs | $ 173 | 3,300 | |||
Termination costs in connection with the reduction in workforce, including severance, benefits and related costs | 2,800 | ||||
Non-cash asset impairments | 700 | ||||
Non-cash gain due to write-off of remaining deferred rent liability | 400 | ||||
Expenses associated with lease termination or prepaid expenses | 200 | ||||
Fixed asset impairments | $ 500 |
Restructuring Costs - Accrual R
Restructuring Costs - Accrual Rollforward (Details) $ in Thousands | 3 Months Ended | 6 Months Ended | 12 Months Ended |
Jun. 30, 2019USD ($) | Jun. 30, 2019USD ($) | Jun. 30, 2019USD ($) | |
Restructuring costs | |||
Charges incurred | $ 45 | $ 176 | |
Cambridge, Massachusetts facility operations | |||
Restructuring costs | |||
Accrued restructuring balance, beginning of period | 1,147 | ||
Charges incurred | 173 | $ 3,300 | |
Cash payments | (859) | ||
Accrued restructuring balance, end of period | 461 | 461 | 461 |
Restructuring Reserve, Noncurrent | 100 | 100 | 100 |
Cambridge, Massachusetts facility operations | Employee Severance and Benefits | |||
Restructuring costs | |||
Accrued restructuring balance, beginning of period | 1,147 | ||
Charges incurred | 173 | ||
Cash payments | (859) | ||
Accrued restructuring balance, end of period | $ 461 | $ 461 | $ 461 |
Stock-Based Compensation - Equi
Stock-Based Compensation - Equity Incentive Plans (Details) - shares | Jul. 26, 2013 | Jun. 30, 2019 | Dec. 31, 2018 |
Class of Stock | |||
Common stock options outstanding | 3,844,377 | 3,304,531 | |
Options outstanding under earlier plans | 457,997 | ||
Grant of inducement stock option | 393,750 | ||
2013 Stock Incentive Plan | |||
Class of Stock | |||
Common shares available for grant | 5,653,057 | 2,703,719 | |
Maximum number of additional common shares | 868,372 | ||
Common stock options outstanding | 2,992,630 | ||
Restricted stock units outstanding | 193,625 |
Stock-Based Compensation - Empl
Stock-Based Compensation - Employee Stock Purchase Plans (Details) - USD ($) $ in Millions | Jun. 07, 2017 | Jun. 30, 2019 | Jun. 30, 2018 |
2017 Employee Stock Purchase Plan | |||
Class of Stock | |||
Maximum percentage of total combined voting power or value of the stock of the Company after the grant | 5.00% | ||
Common shares available for grant | 351,724 | ||
2017 Employee Stock Purchase Plan | Maximum | |||
Class of Stock | |||
Common stock shares authorized for issuance under stock purchase plan | 412,500 | ||
Employee Stock Purchase Plans | |||
Class of Stock | |||
Common stock share issued | 30,570 | 13,112 | |
Proceeds from employee stock purchase plan | $ 0.1 | $ 0.1 |
Stock-Based Compensation - Acco
Stock-Based Compensation - Accounting for Stock-based Compensation (Details) - USD ($) $ / shares in Units, $ in Thousands | 3 Months Ended | 6 Months Ended | ||
Jun. 30, 2019 | Jun. 30, 2018 | Jun. 30, 2019 | Jun. 30, 2018 | |
Share-based Compensation Arrangement by Share-based Payment Award | ||||
Percentage of share-based compensation expense | 15.00% | |||
Weighted average grant date fair value of options granted during the period (per share) | $ 1.83 | $ 9.76 | ||
Stock-based compensation | $ 889 | $ 1,538 | $ 1,905 | $ 3,127 |
Research and development | ||||
Share-based Compensation Arrangement by Share-based Payment Award | ||||
Stock-based compensation | 332 | 549 | 668 | 1,127 |
Research and development | Employee Stock Purchase Plans | ||||
Share-based Compensation Arrangement by Share-based Payment Award | ||||
Stock-based compensation | 12 | 29 | 18 | 51 |
Research and development | Equity Incentive Plans | ||||
Share-based Compensation Arrangement by Share-based Payment Award | ||||
Stock-based compensation | 320 | 520 | 650 | 1,076 |
General and administrative | ||||
Share-based Compensation Arrangement by Share-based Payment Award | ||||
Stock-based compensation | 557 | 989 | 1,237 | 2,000 |
General and administrative | Employee Stock Purchase Plans | ||||
Share-based Compensation Arrangement by Share-based Payment Award | ||||
Stock-based compensation | 8 | 18 | 14 | 32 |
General and administrative | Equity Incentive Plans | ||||
Share-based Compensation Arrangement by Share-based Payment Award | ||||
Stock-based compensation | $ 549 | $ 971 | $ 1,223 | $ 1,968 |
Stock-Based Compensation - Assu
Stock-Based Compensation - Assumptions Used in Determining Fair Value of Stock Options (Details) - $ / shares | 6 Months Ended | |
Jun. 30, 2019 | Jun. 30, 2018 | |
Summary of Significant Accounting Policies | ||
Options to purchase common stock granted to employees and directors | 610,002 | 569,199 |
Average risk free interest rate | 2.30% | 2.20% |
Dividend rate | 0.00% | 0.00% |
Expected lives (years) | 4 years | 3 years 10 months 24 days |
Expected volatility | 82.80% | 75.60% |
Weighted average exercise price of options granted during the period (per share) | $ 3.02 | $ 17.42 |
Stock-Based Compensation - Stoc
Stock-Based Compensation - Stock Option Activity (Details) - USD ($) $ / shares in Units, $ in Thousands | 6 Months Ended | 12 Months Ended | |
Jun. 30, 2019 | Jun. 30, 2018 | Dec. 31, 2018 | |
Options, Outstanding, Beginning Balance | 3,304,531 | ||
Granted | 610,002 | ||
Forfeited | (60,595) | ||
Expired | (9,561) | ||
Options, Outstanding, Ending Balance | 3,844,377 | 3,304,531 | |
Exercisable, Ending Balance | 2,217,289 | ||
Weighted Average Exercise Price, Beginning Balance | $ 18.42 | ||
Granted, Weighted Average Exercise Price | 3.02 | $ 17.42 | |
Forfeited, Weighted Average Exercise Price | 13.36 | ||
Expired, Weighted Average Exercise Price | 40.42 | ||
Weighted Average Exercise Price, Ending Balance | 15.99 | $ 18.42 | |
Exercisable, Weighted Average Exercise Price | $ 21.36 | ||
Outstanding, Ending balance, Weighted Average Remaining Contractual Term | 6 years 7 months 6 days | 6 years 7 months 6 days | |
Exercisable Ending Balance, Weighted Average Remaining Contractual Term | 4 years 10 months 24 days | ||
Outstanding, Intrinsic Value, Ending Balance | $ 9 | ||
Fair value of options, vested | 2,500 | ||
Unrecognized compensation cost related to nonvested stock-based compensation | $ 6,200 | ||
Weighted average remaining period over which unrecognized compensation expense will be recognized | 2 years 6 months | ||
Restricted Stock Activity | |||
Unrecognized compensation cost related to nonvested stock-based compensation | $ 500 | ||
Weighted average remaining period over which unrecognized compensation expense will be recognized | 3 years 6 months |
Stock-Based Compensation - Rest
Stock-Based Compensation - Restricted Stock Activity (Details) $ / shares in Units, $ in Millions | 6 Months Ended |
Jun. 30, 2019USD ($)$ / sharesshares | |
Restricted Stock Activity, Weighted-Average Grant Date Fair Value | |
Unrecognized compensation expense | $ | $ 6.2 |
Weighted average remaining period over which unrecognized compensation expense will be recognized | 2 years 6 months |
Restricted Stock Activity | |
Restricted Stock Activity, Number of Shares | |
Granted | shares | 194,550 |
Cancelled | shares | (925) |
Nonvested shares, Ending Balance | shares | 193,625 |
Restricted Stock Activity, Weighted-Average Grant Date Fair Value | |
Granted, Weighted-Average Grant Date Fair Value | $ / shares | $ 3.14 |
Cancelled, Weighted-Average Grant Date Fair Value | $ / shares | 3.14 |
Nonvested shares, Weighted Average Grant Date Fair Value, Ending Balance | $ / shares | $ 3.14 |
Unrecognized compensation expense | $ | $ 0.5 |
Weighted average remaining period over which unrecognized compensation expense will be recognized | 3 years 6 months |
Related Party Transactions - Ov
Related Party Transactions - Overview of Related Parties (Details) - USD ($) $ / shares in Units, $ in Millions | 6 Months Ended | ||
Jun. 30, 2019 | Jun. 30, 2018 | Dec. 31, 2018 | |
Related Party Transactions | |||
Exercise price of warrants | $ 0.08 | $ 0.08 | |
Number of Warrants | 2,768,882 | 2,768,882 | |
Common stock issued in lieu of board fees | 26,331 | 4,727 | |
Maximum | |||
Related Party Transactions | |||
Proceeds from issuance of common stock in lieu of director board and committee fees | $ 0.1 | $ 0.1 | |
Common Stock | Board of Director | |||
Related Party Transactions | |||
Ownership percentage | 16.00% | ||
Baker Bros. Advisors LP | |||
Related Party Transactions | |||
Number of warrants exercised | 2,539,541 | ||
Exercise price of warrants | $ 3.76 | ||
Proceeds from exercise of warrants | $ 9.5 | ||
Warrants Issued | 60,070 | ||
Baker Bros. Advisors LP | Pre-funded Warrants | |||
Related Party Transactions | |||
Exercise price of warrants | $ 0.08 | ||
Number of Warrants | 2,708,812 |
Net Loss per Common Share (Deta
Net Loss per Common Share (Details) - shares | 6 Months Ended | |
Jun. 30, 2019 | Jun. 30, 2018 | |
Net Loss per Common Share | ||
Total antidilutive securities | 6,808,810 | 5,725,883 |