Document and Entity Information
Document and Entity Information - shares | 3 Months Ended | |
Mar. 31, 2019 | May 03, 2019 | |
Document and Entity Information | ||
Document Type | 10-Q | |
Amendment Flag | false | |
Document Period End Date | Mar. 31, 2019 | |
Document Fiscal Year Focus | 2019 | |
Document Fiscal Period Focus | Q1 | |
Entity Registrant Name | SELECTA BIOSCIENCES INC | |
Entity Central Index Key | 0001453687 | |
Current Fiscal Year End Date | --12-31 | |
Entity Filer Category | Accelerated Filer | |
Entity Emerging Growth Company | true | |
Entity Smaller Reporting Company | true | |
Entity Extended Transition Period | true | |
Entity Common Stock, Shares Outstanding | 44,788,025 |
Consolidated Balance Sheets
Consolidated Balance Sheets - USD ($) $ in Thousands | Mar. 31, 2019 | Dec. 31, 2018 |
Current assets: | ||
Cash, cash equivalents, and restricted cash | $ 32,452 | $ 37,403 |
Short-term deposits and investments | 16,244 | 0 |
Prepaid expenses and other current assets | 10,832 | 4,673 |
Total current assets | 59,528 | 42,076 |
Property and equipment, net | 1,799 | 2,127 |
Right of use asset, net (Note 9) | 1,155 | |
Restricted cash and other assets | 0 | 279 |
Total assets | 62,482 | 44,482 |
Current liabilities: | ||
Accounts payable | 693 | 1,100 |
Accrued expenses | 8,500 | 11,700 |
Loan payable, current portion | 21,466 | 21,385 |
Lease liability, current portion (Note 9) | 1,428 | |
Deferred revenue, current portion | 959 | 959 |
Total current liabilities | 33,046 | 35,144 |
Non‑current liabilities: | ||
Deferred rent and lease incentive | 0 | 34 |
Deferred revenue, net of current portion | 13,816 | 13,818 |
Other long‑term liabilities | 801 | 904 |
Total liabilities | 47,663 | 49,900 |
Commitments and contingencies (Note 18) | ||
Stockholders’ equity (deficit): | ||
Preferred stock, $0.0001 par value; 10,000,000 shares authorized; no shares issued and outstanding at March 31, 2019 and December 31, 2018, respectively | 0 | 0 |
Common stock, $0.0001 par value; 200,000,000 shares authorized; 44,788,025 and 22,471,776 shares issued and outstanding as of March 31, 2019 and December 31, 2018, respectively | 5 | 3 |
Additional paid-in capital | 311,824 | 279,539 |
Accumulated deficit | (292,477) | (280,403) |
Accumulated other comprehensive loss | (4,533) | (4,557) |
Total stockholders’ equity (deficit) | 14,819 | (5,418) |
Total liabilities and stockholders’ equity | $ 62,482 | $ 44,482 |
Consolidated Balance Sheets (Pa
Consolidated Balance Sheets (Parenthetical) - $ / shares | Mar. 31, 2019 | Dec. 31, 2018 |
Statement of Financial Position [Abstract] | ||
Preferred stock, par value (in dollars per share) | $ 0.0001 | $ 0.0001 |
Preferred stock, shares authorized | 10,000,000 | 10,000,000 |
Preferred stock, shares issued | 0 | 0 |
Preferred stock, shares outstanding | 0 | 0 |
Common stock, par value (in dollars per share) | $ 0.0001 | $ 0.0001 |
Common stock, shares authorized | 200,000,000 | 200,000,000 |
Common stock, shares issued | 44,788,025 | 22,471,776 |
Common stock, shares outstanding | 44,788,025 | 22,471,776 |
Consolidated Statements of Oper
Consolidated Statements of Operations and Comprehensive Loss - USD ($) $ in Thousands | 3 Months Ended | |
Mar. 31, 2019 | Mar. 31, 2018 | |
Statement of Comprehensive Income [Abstract] | ||
Grant and collaboration revenue | $ 10 | $ 0 |
Operating expenses: | ||
Research and development | 7,353 | 11,139 |
General and administrative | 4,513 | 4,674 |
Total operating expenses | 11,866 | 15,813 |
Loss from operations | (11,856) | (15,813) |
Investment income | 277 | 288 |
Foreign currency transaction (loss), net | (30) | (13) |
Interest expense | (396) | (350) |
Other (expense), net | (69) | 0 |
Net loss | (12,074) | (15,888) |
Other comprehensive loss: | ||
Foreign currency translation adjustment | 22 | 19 |
Unrealized gain on securities | 2 | 3 |
Total comprehensive loss | (12,050) | (15,866) |
Net loss attributable to common stockholders | $ (12,074) | $ (15,888) |
Net loss per share: | ||
Net loss per share attributable to common stockholders—basic and diluted (in dollars per share) | $ (0.31) | $ (0.71) |
Weighted average common shares outstanding: | ||
Basic and diluted (in shares) | 38,447,319 | 22,345,523 |
Consolidated Statements of Chan
Consolidated Statements of Changes in Stockholders’ Equity (Deficit) - USD ($) $ in Thousands | Total | Common stock | Additional paid-In Capital | Accumulated deficit | Accumulated other comprehensive loss |
Beginning balance (in shares) at Dec. 31, 2017 | 22,343,254 | ||||
Beginning balance at Dec. 31, 2017 | $ 51,814 | $ 3 | $ 273,128 | $ (216,897) | $ (4,420) |
Increase (Decrease) in Stockholders' Equity | |||||
Issuance of common stock under Employee Stock Purchase Plan (in shares) | 6,586 | ||||
Issuance of common stock under Employee Stock Purchase Plan | 53 | 53 | |||
Stock‑based compensation expense | 1,153 | 1,153 | |||
Currency translation adjustment | 19 | 19 | |||
Unrealized gains (losses) on securities | 3 | 3 | |||
Net loss | (15,888) | (15,888) | |||
Ending balance (in shares) at Mar. 31, 2018 | 22,349,840 | ||||
Ending balance at Mar. 31, 2018 | $ 38,984 | $ 3 | 274,334 | (230,955) | (4,398) |
Beginning balance (in shares) at Dec. 31, 2018 | 22,471,776 | 22,471,776 | |||
Beginning balance at Dec. 31, 2018 | $ (5,418) | $ 3 | 279,539 | (280,403) | (4,557) |
Increase (Decrease) in Stockholders' Equity | |||||
Issuance of common stock under Employee Stock Purchase Plan (in shares) | 11,943 | ||||
Issuance of common stock under Employee Stock Purchase Plan | 20 | $ 0 | 20 | ||
Issuance of common stock upon exercise of options (in shares) | 115,600 | ||||
Issuance of common stock upon exercise of options | 145 | 145 | |||
Issuance of common stock, net of issuance costs (in shares) | 22,188,706 | ||||
Issuance of common stock, net of issuance costs of $344.1 | 30,942 | $ 2 | 30,940 | ||
Stock‑based compensation expense | 1,180 | 1,180 | |||
Currency translation adjustment | 22 | 22 | |||
Unrealized gains (losses) on securities | 2 | 2 | |||
Net loss | $ (12,074) | ||||
Ending balance (in shares) at Mar. 31, 2019 | 44,788,025 | 44,788,025 | |||
Ending balance at Mar. 31, 2019 | $ 14,819 | $ 5 | $ 311,824 | $ (292,477) | $ (4,533) |
Consolidated Statements of Ch_2
Consolidated Statements of Changes in Stockholders’ Equity (Deficit) - (Parenthetical) | 3 Months Ended |
Mar. 31, 2019USD ($) | |
Statement of Stockholders' Equity [Abstract] | |
Issuance costs | $ 344,100 |
Consolidated Statements of Cash
Consolidated Statements of Cash Flows - USD ($) $ in Thousands | 3 Months Ended | |
Mar. 31, 2019 | Mar. 31, 2018 | |
Cash flows from operating activities | ||
Net loss | $ (12,074) | $ (15,888) |
Adjustments to reconcile net loss to net cash used in operating activities: | ||
Depreciation | 181 | 169 |
Amortization of premiums (accretion of discounts) on investments | (47) | (32) |
Stock‑based compensation expense | 1,180 | 1,153 |
Non‑cash interest expense | 189 | 177 |
Loss on disposal of property and equipment | 70 | 0 |
Changes in operating assets and liabilities: | ||
Accounts receivable | 0 | 11 |
Prepaid expenses, deposits and other assets | (5,712) | 417 |
Accounts payable | (407) | 180 |
Deferred revenue | (2) | 0 |
Accrued expenses and other liabilities | (3,618) | 404 |
Net cash used in operating activities | (20,240) | (13,409) |
Cash flows from investing activities | ||
Receipts from the maturity of short-term investments | 0 | 15,045 |
Purchases of short-term investments | (18,188) | (13,908) |
Sale of short term investments | 1,992 | 0 |
Purchases of property and equipment | 0 | (192) |
Proceeds from the sale of property and equipment | 77 | 0 |
Net cash provided by (used in) investing activities | (16,119) | 945 |
Cash flows from financing activities | ||
Net proceeds from issuance of common stock | 30,942 | 0 |
Proceeds from exercise of stock options | 145 | 0 |
Proceeds from issuance of common stock under Employee Stock Purchase Plan | 20 | 51 |
Net cash provided by financing activities | 31,107 | 51 |
Effect of exchange rate changes on cash | 22 | 19 |
Net change in cash, cash equivalents, and restricted cash | (5,230) | (12,394) |
Cash, cash equivalents, and restricted cash at beginning of period | 37,682 | 71,027 |
Cash, cash equivalents, and restricted cash at end of period | 32,452 | 58,633 |
Supplement cash flow information | ||
Cash paid for interest | 312 | 261 |
Noncash investing and financing activities | ||
Purchase of property and equipment not yet paid | 0 | 142 |
Equity offering costs in accrued liabilities | 10 | 0 |
Unrealized gain (loss) on marketable securities | $ 2 | $ 3 |
Nature of the Business and Basi
Nature of the Business and Basis of Presentation | 3 Months Ended |
Mar. 31, 2019 | |
Organization, Consolidation and Presentation of Financial Statements [Abstract] | |
Nature of the Business and Basis of Presentation | Nature of the Business and Basis of Presentation Selecta Biosciences, Inc. (the “Company”) was incorporated in Delaware on December 10, 2007, and is based in Watertown, Massachusetts. The Company is a biopharmaceutical company dedicated to developing the first generation of nanoparticle immunomodulatory drugs for the treatment and prevention of human diseases. Since inception, the Company has devoted its efforts principally to research and development of its technology and product candidates, recruiting management and technical staff, acquiring operating assets, and raising capital. The Company is subject to risks common to companies in the biotechnology industry including, but not limited to, new technological innovations, protection of proprietary technology, dependence on key personnel, compliance with government regulations and the need to obtain additional financing. Product candidates currently under development will require significant additional research and development efforts, including extensive preclinical and clinical testing and regulatory approval, prior to commercialization. These efforts require significant amounts of additional capital, adequate personnel infrastructure and extensive compliance-reporting capabilities. The Company’s product candidates are in development. There can be no assurance that the Company’s research and development will be successfully completed, that adequate protection for the Company’s intellectual property will be obtained, that any products developed will obtain necessary government regulatory approval or that any approved products will be commercially viable. Even if the Company’s product development efforts are successful, it is uncertain when, if ever, the Company will generate significant revenue from product sales. The Company operates in an environment of rapid change in technology and substantial competition from pharmaceutical and biotechnology companies. In addition, the Company is dependent upon the services of its employees and consultants. The accompanying financial statements have been prepared on a basis that assumes the Company is a going concern, and does not include any adjustments to reflect the possible future effects on the recoverability and classification of assets or the amounts and classifications of liabilities that may result from any uncertainty related to its ability to continue as a going concern. Unaudited Interim Financial Information The accompanying unaudited consolidated financial statements for the three months ended March 31, 2019 and 2018 have been prepared by the Company, pursuant to the rules and regulations of the Securities and Exchange Commission (the “SEC”) for interim financial statements. Certain information and footnote disclosures normally included in financial statements prepared in accordance with accounting principles generally accepted in the United States of America (“GAAP”) have been condensed or omitted pursuant to such rules and regulations. However, the Company believes that the disclosures are adequate to make the information presented not misleading. These consolidated financial statements should be read in conjunction with the Company’s audited consolidated financial statements and the notes thereto for the year ended December 31, 2018 included in the Company’s Annual Report on Form 10-K that was filed with the SEC on March 15, 2019 (the “Annual Report on Form 10-K”). The unaudited interim financial statements have been prepared on the same basis as the audited consolidated financial statements. In the opinion of management, the accompanying unaudited interim consolidated financial statements contain all adjustments that are necessary for a fair statement of the Company’s financial position as of March 31, 2019 and consolidated results of operations and cash flows for the three months ended March 31, 2019 . Such adjustments are of a normal and recurring nature. The results of operations for the three months ended March 31, 2019 are not necessarily indicative of the results of operations that may be expected for the year ending December 31, 2019. Liquidity and Management's Plan The future success of the Company is dependent on its ability to develop its product candidates and ultimately upon its ability to attain profitable operations. The Company is subject to a number of risks similar to other early-stage life science companies, including, but not limited to, successful development of its product candidates, raising additional capital with favorable terms, protection of proprietary technology and market acceptance of any approved future products. The successful development of product candidates requires substantial working capital which may not be available to the Company on favorable terms. To date, the Company has financed its operations primarily through the initial public offering of its common stock, a private placement of its common stock, issuances of common and preferred stock, debt, research grants and research collaborations. The Company currently has no source of product revenue, and it does not expect to generate product revenue for the foreseeable future. All of its revenue to date has been collaboration and grant revenue. The Company has devoted substantially all of its financial resources and efforts to developing its ImmTOR technology, identifying potential product candidates and conducting preclinical studies and its clinical trials. The Company is in the early stages of development of its product candidates, and it has not completed development of any ImmTOR-enabled therapies. As of March 31, 2019 , the Company’s short-term deposits and investments were $16.2 million , and cash, cash equivalents and restricted cash were $32.5 million , of which $0.4 million was held by its Russian subsidiary designated solely for use in its operations. The Company has incurred losses and negative cash flows from operating activities since inception. As of March 31, 2019 , and December 31, 2018 , the Company had an accumulated deficit of $292.5 million and $280.4 million , respectively. The Company anticipates operating losses to continue for the foreseeable future due to, among other things, costs related to research, development of its product candidates, conducting preclinical studies and clinical trials, and its administrative organization. The Company will require substantial additional financing to fund its operations and to continue to execute its strategy, and the Company will pursue a range of options to secure additional capital. These conditions raise substantial doubt about its ability to continue as a going concern within one year after the date that the financial statements are issued. Management is exploring various sources of funding such as strategic collaborations and the issuance of equity to fund its operations. If the Company raises additional funds through strategic collaborations and alliances, which may include existing collaboration partners, the Company may have to relinquish valuable rights to its technologies or product candidates, or grant licenses on terms that are not favorable to the Company. To the extent that the Company raises additional capital through the sale of equity, the ownership interest of its existing shareholders will be diluted and other preferences may be necessary that adversely affect the rights of existing shareholders. The current operating plan accounts for funding in preparation for the planned Phase 3 clinical program for SEL-212. The Company believes that it has the financial resources to complete the head-to-head Phase 2 trial against Krystexxa, but will require additional external sources of capital to conduct the planned Phase 3 clinical program. If the Company is unable to raise sufficient capital through the transactions discussed above, it intends to curtail expenses contemplated by the current operating plan, and the Company may be required to delay, limit, reduce or terminate its product development efforts or grant rights to develop and market product candidates that it would otherwise prefer to develop and market itself. Because of the uncertainty in securing additional capital and the insufficient amount of capital resources at March 31, 2019 , management has concluded that substantial doubt exists with respect to the Company's ability to continue as a going concern within one year after the date of the filing of this Quarterly Report on Form 10-Q . All amounts due under the 2017 Term Loan (Note 10) have been classified as a current liability as of March 31, 2019 due to the considerations discussed above and the assessment that the material adverse change clause under the 2017 Term Loan is not within the Company's control. The Company has not been notified of an event of default by the Lender as of the date of the filing of this Quarterly Report on Form 10-Q . Guarantees and Indemnifications As permitted under Delaware law, the Company indemnifies its officers, directors, consultants and employees for certain events or occurrences that happen by reason of the relationship with, or position held at, the Company. Through March 31, 2019 |
Summary of Significant Accounti
Summary of Significant Accounting Policies | 3 Months Ended |
Mar. 31, 2019 | |
Accounting Policies [Abstract] | |
Summary of Significant Accounting Policies | Summary of Significant Accounting Policies Principles of Consolidation The consolidated financial statements include the accounts of the Company and its wholly owned subsidiaries, Selecta RUS, LLC (“Selecta (RUS)”), a Russian limited liability corporation, and Selecta Biosciences Security Corporation, a Massachusetts Security Corporation. All significant intercompany accounts and transactions have been eliminated. Foreign Currency The functional currency of Selecta (RUS) is the Russian ruble. Assets and liabilities of Selecta (RUS) are translated at period-end exchange rates, while revenues and expenses are translated at average exchange rates for the period. Translation gains and losses are reflected in accumulated other comprehensive loss within stockholders’ deficit. Foreign currency transaction gains or losses are reflected in the consolidated statements of operations and comprehensive loss. Use of Estimates The preparation of consolidated financial statements in conformity with U.S. GAAP requires the Company’s management to make estimates and assumptions that affect the reported amounts of assets and liabilities, the disclosure of contingent assets and liabilities at the date of the consolidated financial statements and the reported amounts of revenues and expenses during the reporting period. The Company’s management considers many factors in selecting appropriate financial accounting policies and controls, and bases its estimates on historical experience and other market-specific or other relevant assumptions that it believes to be reasonable under the circumstances. In preparing these consolidated financial statements, management used significant estimates in the following areas, among others: revenue recognition, accounting for stock-based compensation and estimating accrued research and development expenses. The Company assesses the above estimates on an ongoing basis; however, actual results could materially differ from those estimates. Segment Information Operating segments are identified as components of an enterprise about which separate discrete financial information is available for evaluation by the chief operating decision maker, the Company’s Chief Executive Officer, in making decisions regarding resource allocation and assessing performance. The Company views its operations and manages its business in one operating segment, the research and development of nanoparticle immunomodulatory drugs for the treatment and prevention of human diseases. Cash Equivalents, Short-term Investments and Restricted Cash Cash equivalents include all highly liquid investments maturing within 90 days from the date of purchase. Investments consist of securities with remaining maturities greater than 90 days when purchased. The Company classifies these investments as available-for-sale and records them at fair value in the accompanying consolidated balance sheets. Investments with less than one year until maturity are classified as short term, while investments with maturities greater than one year are classified as long term. Unrealized gains or losses are included in accumulated other comprehensive income (loss). Premiums or discounts from par value are amortized to investment income over the life of the underlying investment. Although available to be sold to meet operating needs or otherwise, securities are generally held through maturity. The cost of securities sold is determined based on the specific identification method for purposes of recording realized gains and losses. During the reporting periods, there were no realized gains or losses on sales of investments, and no investments were adjusted for other than temporary declines in fair value. As of March 31, 2019 , the Company has restricted cash balances relating to a secured letter of credit in connection with its Headquarters Lease (as defined in Note 9). The following table provides a reconciliation of cash, cash equivalents, and restricted cash reported within the consolidated balance sheet that sum to the total of the same such amounts shown in the consolidated statement of cash flows: Three Months Ended March 31, 2019 2018 Cash and cash equivalents $ 32,173 $ 58,228 Restricted cash 279 76 Restricted cash included in other assets — 329 Total cash, cash equivalents, and restricted cash shown in the consolidated statement of cash flows $ 32,452 $ 58,633 Concentrations of Credit Risk and Off‑Balance Sheet Risk Financial instruments that potentially subject the Company to concentration of credit risk consist primarily of cash, cash equivalents, short-term deposits and investments, and accounts receivable. Cash and cash equivalents are deposited with federally insured financial institutions in the United States and may, at times, exceed federally insured limits. Management believes that the financial institutions that hold the Company’s deposits are financially credit worthy and, accordingly, minimal risk exists with respect to those balances. Generally, these deposits may be redeemed upon demand and therefore bear minimal interest rate risk. As an integral part of operating its Russian subsidiary, the Company also maintains cash in Russian bank accounts in denominations of both Russian rubles and U.S. dollars. As of March 31, 2019 , the Company maintained approximately $0.4 million in Russian bank accounts, of which $0.4 million was held in U.S. dollars. The Company did not have any off-balance sheet arrangements as of March 31, 2019 and December 31, 2018 . Fair Value of Financial Instruments The Company’s financial instruments consist mainly of cash equivalents, short‑term investments, restricted cash, accounts payable, loans payable, and common stock warrants. The carrying amounts of cash equivalents, short-term investments, restricted cash, accounts receivable, and accounts payable approximate their estimated fair value due to their short-term maturities. At March 31, 2019 , the carrying amount of the Company's loan payable approximates its estimated fair value due to the short-term nature of the instrument. Accounting standards define fair value as 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. A three‑level hierarchy is used to prioritize the inputs to valuation techniques used to measure fair value. The hierarchy gives the highest priority to unadjusted quoted prices in active markets for identical assets or liabilities (Level 1 measurements), and the lowest priority to unobservable inputs (Level 3 measurements). The three levels of the fair value hierarchy are described below: Level 1 —Level 1 inputs are quoted prices in active markets for identical assets or liabilities that the reporting entity has the ability to access at the measurement date. Level 2 —Level 2 inputs are inputs other than quoted prices included within Level 1 that are observable for the asset or liability, either directly or indirectly. If the asset or liability has a specified (contractual) term, a Level 2 input must be observable for substantially the full term of the asset or liability. Level 3 —Level 3 inputs are unobservable inputs for the asset or liability in which there is little, if any, market activity for the asset or liability at the measurement date. To the extent that a valuation is based on models or inputs that are less observable or unobservable in the market, the determination of fair value requires more judgment. Accordingly, the degree of judgment exercised by the Company in determining fair value is greatest for instruments categorized in Level 3. A financial instrument’s level within the fair value hierarchy is based on the lowest level of any input that is significant to the fair value measurement. The fair value of the Company's loan payable was determined using Level 2 inputs. Fair value is a market‑based measure considered from the perspective of a market participant rather than an entity‑specific measure. Therefore, even when market assumptions are not readily available, the Company’s own assumptions are set to reflect those that market participants would use in pricing the asset or liability at the measurement date. The Company uses prices and inputs that are current as of the measurement date, including during periods of market dislocation. In periods of market dislocation, the observability of prices and inputs may change for many instruments. This condition could cause an instrument to be reclassified within levels in the fair value hierarchy. There were no transfers within the fair value hierarchy during the three months ended March 31, 2019 or the year ended December 31, 2018 . Property and Equipment Property and equipment are recorded at cost and depreciated using the straight‑line method over the estimated useful lives of the respective assets, generally seven years for furniture and fixtures, five years for laboratory equipment, software and office equipment and three years for computer equipment. Leasehold improvements are amortized over their useful life or the life of the lease, whichever is shorter. Major additions and betterments are capitalized. Maintenance and repairs, which do not improve or extend the life of the respective assets, are charged to operations as incurred. Costs incurred for construction in progress are recorded as assets and are not amortized until the construction is substantially complete and the assets are ready for their intended use. Impairment of Long‑Lived Assets The Company reviews long‑lived assets for impairment whenever events or changes in circumstances indicate that the carrying value of an asset may not be recoverable. In order to determine if assets have been impaired, assets are tested at the lowest level for which identifiable independent cash flows are available, which is at the entity level ("asset group"). An impairment loss is recognized when the sum of projected undiscounted cash flows is less than the carrying value of the asset group. The measurement of the impairment loss to be recognized is based on the difference between the fair value and the carrying value of the asset group. Based on management's evaluation, the fair value of the asset group, measured as the market capitalization of the Company exceeds its carrying value, and for this reason the Company did no t recognize any material impairment losses during the three months ended March 31, 2019 and 2018 . Debt Issuance Costs Debt issuance costs and fees paid to lenders are classified as a debt discount and are recorded as a direct deduction from the face amount of the related debt. Issuance costs paid to third parties that are the direct result of the debt issuance are capitalized as a direct deduction from the face amount of the related debt. Debt issuance costs are amortized over the term of the related debt using the interest method and recorded as interest expense. Costs and fees paid to third parties are expensed as incurred. Accumulated Other Comprehensive Income (Loss) Comprehensive income (loss) is defined as the change in the equity of a business entity during a period from transactions and other events and circumstances from non‑owner sources. It includes all changes in equity during a period except those resulting from investments by owners and distributions to owners. Comprehensive income (loss) consists of: (i) all components of net loss and (ii) all components of comprehensive loss other than net loss, referred to as other comprehensive loss. Other comprehensive loss is comprised of foreign currency translation adjustments and the unrealized gains and losses on available-for-sale securities. The components of accumulated other comprehensive income (loss), net of tax, were as follows (in thousands): Foreign currency translation adjustment Unrealized gains (losses) on available-for-sale securities Accumulated other comprehensive income (loss) Balance at December 31, 2018 $ (4,557 ) $ — $ (4,557 ) Other comprehensive income (loss) during the period $ 22 $ 2 $ 24 Balance at March 31, 2019 $ (4,535 ) $ 2 $ (4,533 ) Revenue Recognition Revenue is recognized when a 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. To determine revenue recognition for arrangements that an entity determines are within the scope of ASC 606, the Company performs the following five steps: (i) identify the contract(s) with a customer; (ii) identify the performance obligations in the contract, including whether they are distinct in the context of the contract; (iii) determine the transaction price, including the constraint on variable consideration; (iv) allocate the transaction price to the performance obligations in the contract; and (v) recognize revenue when (or as) the Company satisfies each performance obligation. The Company only applies the five-step model to contracts when it is probable that the entity will collect the consideration it is entitled to in exchange for the goods or services it transfers to the customer. At contract inception, once the contract is determined to be within the scope of ASC 606, the Company assesses the goods or services promised within each contract and determines those that are performance obligations, and assesses whether each promised good or service is distinct. If a promised good or service is not distinct, it is combined with other performance obligations. The Company then recognizes as revenue the amount of the transaction price that is allocated to the respective performance obligation when (or as) the performance obligation is satisfied. For example, certain performance obligations associated with Spark (see Note 13 to the Company's consolidated financial statements included elsewhere in this Quarterly Report on Form 10-Q ) will be satisfied over time, and revenue will be recognized using the output method, based on the proportion of actual deliveries to the total expected deliveries over the initial term. Collaboration and Grant Revenue The Company currently generates its revenue through grants, collaboration and license agreements with strategic collaborators for the development and commercialization of product candidates. The grants, collaboration and license agreements are within the scope of ASC 606. In determining the appropriate amount of revenue to be recognized as it fulfills its obligations under the agreements, the Company performs the five steps above. As part of the accounting for the arrangement, the Company must develop assumptions that require judgment to determine the stand-alone selling price for each performance obligation identified in the contract. The Company uses key assumptions to determine the stand-alone selling price, which may include market conditions, reimbursement rates for personnel costs, development timelines and probabilities of regulatory success. Licenses of intellectual property: If the license to the Company’s intellectual property is determined to be distinct from the other performance obligations identified in the arrangement, the Company recognizes revenues from non-refundable, up-front fees allocated to the license when the license is transferred to the customer and the customer is able to use and benefit from the license. If not distinct, the license is combined with other performance obligations in the contract. For licenses that are combined with other performance obligations, the Company assesses the nature of the combined performance obligation to determine whether the combined performance obligation is satisfied over time or at a point in time and, if over time, the appropriate method of measuring progress for purposes of recognizing revenue. The Company evaluates the measure of progress each reporting period and, if necessary, adjusts the measure of performance and related revenue recognition. Optional licenses are evaluated to determine if they are issued at a discount, and therefore, represent material rights and accounted for as separate performance obligations. Milestone Payments: At the inception of each arrangement that includes developmental and regulatory milestone payments, the Company evaluates whether the achievement of each milestone specifically relates to the Company’s efforts to satisfy a performance obligation or transfer a distinct good or service within a performance obligation. If the achievement of a milestone is considered a direct result of the Company’s efforts to satisfy a performance obligation or transfer a distinct good or service and the receipt of the payment is based upon the achievement of the milestone, the associated milestone value is allocated to that distinct good or service. If the milestone payment is not specifically related to the Company’s effort to satisfy a performance obligation or transfer a distinct good or service, the amount is allocated to all performance obligations using the relative standalone selling price method. The Company also evaluates the milestone to determine whether they are considered probable of being reached and estimates the amount to be included in the transaction price using the most likely amount method. If it is probable that a significant revenue reversal would not occur, the associated milestone value is included in the transaction price to be allocated, otherwise, such amounts are constrained and excluded from the transaction price. At the end of each subsequent reporting period, the Company re-evaluates the probability of achievement of such development milestones and any related constraint, and if necessary, adjusts its estimate of the transaction price. Any such adjustments to the transaction price are allocated to the performance obligations on the same basis as at contract inception. Amounts allocated to a satisfied performance obligation shall be recognized as revenue, or as a reduction of revenue, in the period in which the transaction price changes. Manufacturing Supply Services: Arrangements that include a promise for future supply of drug substance or drug product for either clinical development or commercial supply at the customer’s discretion are evaluated to determine if they are distinct and optional. For optional services that are distinct, the Company assesses if they are priced at a discount, and therefore, provide a material right to the licensee to be accounted for as separate performance obligations. Royalties: For arrangements that include sales-based royalties, including milestone payments based on the level of sales, and the license is deemed to be the predominant item to which the royalties relate, the Company will recognize revenue at the later of (i) when the related sales occur, or (ii) when the performance obligation to which some or all of the royalty has been allocated has been satisfied (or partially satisfied) in accordance with the royalty recognition constraint. Research and Development Costs Costs incurred in the research and development of the Company’s products are expensed as incurred. Research and development expenses include costs incurred in performing research and development activities, including salaries and benefits, facilities cost, overhead costs, contract services, supplies and other outside costs. Nonrefundable advance payments for goods and services that will be used in future research and development activities are expensed when the activity has been performed or when the goods have been received rather than when the payment is made. Clinical Trial Costs Clinical trial expenses are a significant component of research and development expenses, and we outsource a significant portion of these costs to third parties. Third party clinical trial expenses include patient costs, clinical research organization costs and costs for data management. The accrual for site and patient costs includes inputs such as estimates of patient enrollment, patient cycles incurred, clinical site activations, and other pass-through costs. Payments for these activities are based on the terms of the individual arrangements, which may differ from the pattern of costs incurred, and are reflected on the consolidated balance sheets as a prepaid asset or accrued clinical trial cost. These third party agreements are generally cancelable, and related costs are recorded as research and development expenses as incurred. Non-refundable advance clinical payments for goods or services that will be used or rendered for future R&D activities are recorded as a prepaid asset and recognized as expense as the related goods are delivered or the related services are performed. We also record accruals for estimated ongoing clinical research and development costs. When evaluating the adequacy of the accrued liabilities, we analyze progress of the studies, including the phase or completion of events, invoices received and contracted costs. Significant judgments and estimates may be made in determining the accrued balances at the end of any reporting period. Actual results could differ from the estimates made by the Company. The historical clinical accrual estimates made by the Company have not been materially different from the actual costs. Income Taxes The Company provides deferred tax assets and liabilities for the expected future tax consequences of temporary differences between the Company’s financial statement carrying amounts and the tax basis of assets and liabilities using enacted tax rates expected to be in effect in the years in which the differences are expected to reverse. A valuation allowance is provided to reduce the deferred tax assets to the amount that will more-likely-than-not be realized. The Company determines whether it is more likely than not that a tax position will be sustained upon examination. If it is not more-likely-than-not that a position will be sustained, none of the benefit attributable to the position is recognized. The tax benefit to be recognized for any tax position that meets the more‑likely‑than‑not recognition threshold is calculated as the largest amount that is more than 50% likely of being realized upon resolution of the contingency. The Company accounts for interest and penalties related to uncertain tax positions as part of its provision for income taxes. To date, the Company has not incurred interest and penalties related to uncertain tax positions. Warrants The Company determines the accounting classification of warrants that are issued, as either liability or equity, by first assessing whether the warrants meet liability classification in accordance with ASC 480-10, Accounting for Certain Financial Instruments with Characteristics of both Liabilities and Equity , and then in accordance with ASC 815-40, Accounting for Derivative Financial Instruments Indexed to, and Potentially Settled in, a Company’s Own Stock . Under ASC 480, warrants are considered liability classified if the warrants are mandatorily redeemable, obligate the issuer to settle the warrants or the underlying shares by paying cash or other assets, or warrants that must or may require settlement by issuing variable number of shares. If warrants do not meet liability classification under ASC 480-10, the Company assesses the requirements under ASC 815-40, which states that contracts that require or may require the issuer to settle the contract for cash are liabilities recorded at fair value, irrespective of the likelihood of the transaction occurring that triggers the net cash settlement feature. If the warrants do not require liability classification under ASC 815-40, in order to conclude equity classification, the Company assesses whether the warrants are indexed to its common stock and whether the warrants are classified as equity under ASC 815-40 or other applicable GAAP. After all relevant assessments are made, the Company concludes whether the warrants are classified as liability or equity. Liability classified warrants are required to be accounted for at fair value both on the date of issuance and on subsequent accounting period ending dates, with all changes in fair value after the issuance date recorded in the statements of operations as a gain or loss. Equity classified warrants are accounted for at fair value on the issuance date with no changes in fair value recognized after the issuance date. Stock‑Based Compensation The Company accounts for all stock‑based compensation granted to employees and non‑employees using a fair value method. Stock‑based compensation is measured at the grant date fair value and is recognized over the requisite service period of the awards, usually the vesting period, on a straight‑line basis, net of estimated forfeitures. The Company reduces recorded stock‑based compensation for estimated forfeitures. To the extent that actual forfeitures differ from the Company’s estimates, the differences are recorded as a cumulative adjustment in the period the estimates were adjusted. Stock‑based compensation expense recognized in the consolidated financial statements is based on awards that are ultimately expected to vest. Net Loss Per Share The Company has reported losses since inception and has computed basic net loss per share by dividing net loss by the weighted average number of common shares outstanding for the period. The Company has computed diluted net loss per common share after considering all potentially dilutive common shares, including stock options, convertible preferred stock, and warrants outstanding during the period except where the effect of including such securities would be antidilutive. Because the Company has reported net losses since inception, these potential common shares have been anti‑dilutive and basic and diluted loss per share have been the same. Contingent Liabilities The Company accounts for its contingent liabilities in accordance with ASC No. 450, Contingencies . A provision is recorded when it is both probable that a liability has been incurred and the amount of the loss can be reasonably estimated. With respect to legal matters, provisions are reviewed and adjusted to reflect the impact of negotiations, estimated settlements, legal rulings, advice of legal counsel and other information and events pertaining to a particular matter. As of March 31, 2019 and December 31, 2018 , the Company was not a party to any litigation that could have a material adverse effect on the Company’s business, financial position, results of operations or cash flows. Leases Under ASC 842 which was adopted January 1, 2019, the Company determines whether the arrangement is or contains a lease based on the unique facts and circumstances present. Most leases with a term greater than one year are recognized on the balance sheet as right-of-use assets, lease liabilities and, if applicable, long-term lease liabilities. The Company elected not to recognize leases with a term less than one year on our balance sheet. Operating lease right-of-use (ROU) assets and their corresponding lease liabilities are recorded based on the present value of lease payments over the expected remaining lease term. The interest rate implicit in lease contracts is typically not readily determinable. As a result, the Company utilizes its incremental borrowing rates, which are the rates incurred to borrow on a collateralized basis over a similar term, an amount equal to the lease payments in a similar economic environment. In accordance with the guidance in ASU 2016-02, components of a lease should be split into three categories: lease components (e.g. land, building, etc.), non-lease components (e.g. common area maintenance, consumables, etc.), and non-components (e.g. property taxes, insurance, etc.) Then the fixed and in-substance fixed contract consideration (including any related to non-components) must be allocated based on fair values to the lease components and non-lease components. Although separation of lease and non-lease components is required, the Company elected the practical expedient to not separate lease and non-lease components. The lease component results in an operating right-of-use asset being recorded on the balance sheet and amortized on a straight-line basis as lease expense. See Note 9 for details. Under prior guidance ASC 840, rent expense and lease incentives from operating leases were recognized on a straight‑line basis over the lease term. The difference between rent expense recognized and rental payments was recorded as deferred rent in the accompanying consolidated balance sheets. Recent Accounting Pronouncements In June 2016, the FASB issued Accounting Standards Update No. ("ASU") 2016-13, Financial Instruments-Credit Losses (Topic 326), Measurement of Credit Losses on Financial Instruments. Subsequently, in November 2018, the FASB issued ASU 2018-19, “Codification Improvements to Topic 326, Financial Instruments-Credit Losses”. ASU 2016-13 requires entities to measure all expected credit losses for most financial assets held at the reporting date based on an expected loss model which includes historical experience, current conditions, and reasonable and supportable forecasts. ASU 2016-13 also requires enhanced disclosures to help financial statement users better understand significant estimates and judgments used in estimating credit losses. This ASU is effective for public entities for fiscal years beginning after December 15, 2019, with early adoption permitted. The Company is assessing the impact this standard will have on its consolidated financial statements and disclosures. In February 2016, the FASB issued Accounting Standards Update No. (“ASU”) 2016-02, “Leases (Topic 842).” ASU 2016-02 requires lessees to recognize most leases on their balance sheet as a right-of-use asset and a lease liability. Leases are classified as either operating or finance based on criteria similar to current lease accounting, with the classification affecting the pattern and classification of expense recognition in the statement of operations. Subsequently, in July 2018, the FASB issued ASU No. 2018-11, Leases (Topic 842): Targeted Improvements (“ASU 2018-11”), which includes certain amendments to ASU 2016-02 intended to provide relief in implementing the new standard. Among these amendments is the option to not restate comparative periods presented in the financial statements. The Company has elected this transition approach, using a cumulative-effect adjustment on the effective date of the standard, with comparative periods presented in accordance with the existing guidance in ASC 840. Pursuant to the guidance under ASU 2016-02, the Company elected certain available expedients by electing the transition package of practical expedients permitted with ASU 2016-02, which allows the Company the option not to reassess previous accounting conclusions around, (i) whether expired or existing contracts contain leases, (ii) lease classification for any expired or existing leases, and (iii) the treatment of initial direct costs for any existing leases. The Company also made an accounting policy election to exclude leases with an initial term of 12 months or less from their balance sheet. The Company adopted the new standard as of the required effective date of January 1, 2019 resulting in the recognition of a net additional lease liability and right-of-use asset. The standard did not impact the Company's consolidated net loss or cash flows. See Note 9 for details. In August 2018, the FASB issued ASU No. 2018-13, " Fair Value Measurement (Topic 820): Changes to the Disclosure Requirements for Fair Value Measurement" (ASU 2018-13) which changes the fair value measurement disclosure requirements of ASC 820. This ASU is effective for public entities for fiscal years beginning after December 15, 2019, with early adoption permitted. The Company is assessing the impact this standard will have on its consolidated financial statements and disclosures. In November 2018, the FASB issued ASU No. 2018-18, “Collaborative Arrangements (Topic 808): Clarifying the Interaction between Topic 808 and Topic 606” |
Available-for-Sale Marketable S
Available-for-Sale Marketable Securities | 3 Months Ended |
Mar. 31, 2019 | |
Investments, Debt and Equity Securities [Abstract] | |
Available-for-Sale Marketable Securities | Available-for-Sale Marketable Securities As of March 31, 2019 , the Company’s available-for-sale marketable securities consisted of U.S. government and agency securities, commercial paper and corporate bonds. As of December 31, 2018 , the Company did not have available-for-sale marketable securities. The following tables summarize the Company’s available-for-sale marketable securities by major type of security as of March 31, 2019 (in thousands): March 31, 2019 Amortized Cost Gross Unrealized Gains Gross Unrealized Losses Fair Value U.S. government and agency securities $ 9,935 $ 1 $ — $ 9,936 Corporate bonds and commercial paper 6,308 — — 6,308 Total available-for-sale marketable securities $ 16,243 $ 1 $ — $ 16,244 All available-for-sale marketable securities are classified in the Company’s consolidated balance sheets as short-term deposits and investments. The Company classifies its marketable debt securities based on their contractual maturity dates. The fair values and amortized cost of marketable debt securities by contractual maturity were as follows (in thousands): March 31, 2019 December 31, 2018 Fair Value Amortized Cost Fair Value Amortized Cost Less than one year $ 16,244 $ 16,243 $ — $ — As of March 31, 2019 the Company held a total of 15 positions, no |
Net Loss Per Share
Net Loss Per Share | 3 Months Ended |
Mar. 31, 2019 | |
Earnings Per Share [Abstract] | |
Net Loss Per Share | Net Loss Per Share The Company has reported a net loss for the three months ended March 31, 2019 , and 2018 , and for this reason basic and diluted net loss per share are the same for all periods presented. The following table sets forth the computation of basic and diluted net loss per share (in thousands, except share and per‑share data): Three Months Ended March 31, 2019 2018 Numerator: Net loss attributable to common stockholders $ (12,074 ) $ (15,888 ) Denominator: Weighted‑average common shares outstanding—basic and diluted 38,447,319 22,345,523 Net loss per share attributable to common stockholders —basic and diluted $ (0.31 ) $ (0.71 ) All potential dilutive common shares have been excluded from the computation of the diluted net loss per share for all periods presented, as the effect would have been anti-dilutive. Potential dilutive common share equivalents consist of the following: March 31, 2019 2018 Stock options to purchase common stock 4,564,742 2,658,035 Unvested restricted stock units 275,000 — Stock warrants to purchase common stock 95,619 176,432 Total 4,935,361 2,834,467 |
Fair Value Measurements
Fair Value Measurements | 3 Months Ended |
Mar. 31, 2019 | |
Fair Value Disclosures [Abstract] | |
Fair Value Measurements | Fair Value Measurements The tables below present information about the Company’s financial assets that are measured and carried at fair value as of March 31, 2019 and December 31, 2018 , and indicate the level within the fair value hierarchy where each measurement is classified. Below is a summary of assets measured at fair value on a recurring basis (in thousands): March 31, 2019 (Level 1) (Level 2) (Level 3) Total Cash equivalents: Money market funds $ 489 $ — $ — $ 489 Total cash equivalents $ 489 $ — $ — $ 489 Short-term investments: U.S. government and agency securities $ — $ 9,936 $ — $ 9,936 Corporate bonds and commercial paper — 6,308 — 6,308 Total short-term investments $ — $ 16,244 $ — $ 16,244 December 31, 2018 (Level 1) (Level 2) (Level 3) Total Cash equivalents: Money market funds $ 10,123 $ — $ — $ 10,123 Total cash equivalents $ 10,123 $ — $ — $ 10,123 At each of March 31, 2019 and December 31, 2018 , cash and cash equivalent investments were held in money market funds maturing within 90 days from the date of purchase. The average maturity date for U.S. government and agency securities, included in investments at March 31, 2019 was 145 days . Fair value of U.S. government and agency securities approximated amortized value at each reporting date. The average maturity date for corporate bonds, included in investments at March 31, 2019 was 250 days . Fair value of corporate bonds approximated amortized value at March 31, 2019 . The average maturity date for commercial paper, included in investments at March 31, 2019 was 139 days . Fair value of commercial paper approximated amortized value at March 31, 2019 |
Property and Equipment
Property and Equipment | 3 Months Ended |
Mar. 31, 2019 | |
Property, Plant and Equipment [Abstract] | |
Property and Equipment | Property and Equipment Property and equipment consists of the following (in thousands): March 31, December 31, 2019 2018 Laboratory equipment $ 4,932 $ 5,379 Computer equipment and software 481 561 Leasehold improvements 278 278 Furniture and fixtures 235 247 Office equipment 135 135 Construction in process — 79 Total property and equipment 6,061 6,679 Less accumulated depreciation (4,262 ) (4,552 ) Property and equipment, net $ 1,799 $ 2,127 Depreciation expense was $0.2 million and $0.2 million for the three months ended March 31, 2019 and 2018 |
Accrued Expenses
Accrued Expenses | 3 Months Ended |
Mar. 31, 2019 | |
Payables and Accruals [Abstract] | |
Accrued Expenses | Accrued Expenses Accrued expenses consist of the following (in thousands): March 31, December 31, 2019 2018 Payroll and employee related expenses $ 1,875 $ 2,497 Current portion of deferred rent and lease incentive — 117 Collaboration and licensing 831 1,222 Accrued patent fees 510 736 Accrued external research and development costs 3,826 5,344 Accrued professional and consulting services 920 994 Accrued grant refund 175 175 Accrued interest 109 106 Other 254 509 Accrued expenses $ 8,500 $ 11,700 |
Prepaid Expenses and Other Curr
Prepaid Expenses and Other Current Assets (Notes) | 3 Months Ended |
Mar. 31, 2019 | |
Deferred Costs, Capitalized, Prepaid, and Other Assets Disclosure [Abstract] | |
Prepaid Expenses and Other Current Assets | Prepaid Expenses and Other Current Assets Prepaid expenses and other current assets consist of the following (in thousands): March 31, December 31, 2019 2018 Clinical operations $ 9,916 $ 3,550 Insurance 222 433 Rent 192 188 Service agreements 426 422 Other 76 80 $ 10,832 $ 4,673 As of March 31, 2019 and December 31, 2018, the clinical operations prepaid expense related to the purchase of inventory to complete the head-to-head Phase 2 trial against Krystexxa was $ 6.2 million and zero |
Leases (Notes)
Leases (Notes) | 3 Months Ended |
Mar. 31, 2019 | |
Leases [Abstract] | |
Leases | Leases On January 1, 2019, the Company adopted Topic 842 using the modified retrospective approach. The Company recorded operating lease assets (right-of-use assets) of $1.6 million and operating lease liabilities of $1.8 million and reversed lease liability of $0.2 million related to straight-line rent and incentives. There was no impact to accumulated deficit upon adoption of Topic 842. The underlying assets of the Company’s leases are primarily office space. The Company determines if an arrangement qualifies as a lease at its inception. As a practical expedient permitted under Topic 842, the Company has elected to account for the lease and non-lease components as a single lease component for all leases of which it is the lessee. Lease payments, which may include lease and non-lease components, are included in the measurement of the Company’s lease liabilities to the extent that such payments are either fixed amounts or variable amounts that depend on a rate or index as stipulated in the lease contract. When the Company cannot readily determine the rate implicit in the lease, the Company determines its incremental borrowing rate by using the rate of interest that it would have to pay to borrow on a collateralized basis over a similar term, an amount equal to the lease payments in a similar economic environment. On January 1, 2019, the discount rate used on existing operating leases at adoption, which had remaining lease terms of 15 months , was 10.0% . For new or renewed leases starting in 2020, the discount rate is determined based on the Company’s incremental borrowing rate adjusted for the lease term including any reasonably certain renewal periods. The Company enters into lease agreements with terms generally ranging from 2 - 5 years . Some of the Company’s lease agreements include Company options to either extend and/or early terminate the lease, the costs of which are included in our operating lease liabilities to the extent that such options are reasonably certain of being exercised. Leases with renewal options allow the Company to extend the lease term typically between 1 and 5 years . When determining the lease term, renewal options reasonably certain of being exercised are included in the lease term. When determining if a renewal option is reasonably certain of being exercised, the Company considers several economic factors, including but not limited to, the significance of leasehold improvements incurred on the property, whether the asset is difficult to replace, underlying contractual obligations, or specific characteristics unique to that particular lease that would make it reasonably certain that the Company would exercise such option. Renewal and termination options were generally not included in the lease term for the Company’s existing operating leases. The Company has a non‑cancellable operating lease for its laboratory and office space located at 480 Arsenal Way, Watertown, Massachusetts (" Headquarters Lease "). As part of the Headquarters Lease agreement, the landlord provided the Company a tenant improvement allowance of up to $0.7 million , which the Company fully utilized during 2012. The leasehold improvements are capitalized as a component of property and equipment. In connection with the Headquarters Lease , the Company secured a letter of credit for $0.3 million which renews automatically each year and is classified in restricted cash and other deposits in the accompanying consolidated balance sheets. In August 2016, the Company signed an amendment to the Headquarters Lease , which extends the term through March 31, 2020. Leases with an initial term of 12 months or less are not recorded on the balance sheet; we recognize lease expense for these leases on a straight-line basis over the lease term. For lease agreements entered into or reassessed after the adoption of Topic 842, lease and nonlease components are combined. In October 2017, the Company entered into a lease for approximately 5,100 square feet of additional office space located in Watertown, Massachusetts. On January 11, 2019, the Company decided to vacate certain office space in Watertown, MA and consolidated all employees at its corporate headquarters at 480 Arsenal Way, Watertown, MA. The lease term expires in March 2020. The ROU asset carrying amount of $0.2 million attributable to 75 North Beacon, Watertown, MA was written down to zero during the first quarter. The Company has a month‑to‑month facility agreement for its Moscow, Russia facility. Rent expense is recognized as incurred. Rent expense for each of the three months ended March 31, 2019 and 2018 was $0.5 million . For the three months ended March 31, 2019, the components of lease costs were as follows (in thousands): March 31, 2019 Operating lease expense $ 341 Variable lease expense 203 Short-term lease expense 8 Total lease expense $ 552 The maturity of the Company's operating lease liabilities as of March 31, 2019 were as follows (in thousands): March 31, Operating leases: 2019 2019 (Remainder) 1,119 2020 375 Total future minimum lease payments 1,494 Less imputed interest 66 Total operating lease liabilities 1,428 Included in the condensed consolidated balance sheet: Current operating lease liabilities 1,428 Non-current operating lease liabilities — Total operating lease liabilities 1,428 The following information represents supplemental disclosure for the statement of cash flows related to operating leases (in thousands): March 31, Operating leases: 2019 Supplemental Cash Flows Information Operating cash flows from operating leases $ 363 The changes in the Company’s right of use asset and lease liability for the months ended March 31, 2019 are reflected in the changes in prepaid expenses, deposits and other assets and accrued expenses and other liabilities, respectively, in the consolidated statements of cash flows. The following summarizes additional information related to operating leases: March 31, Operating leases: 2019 Weighted-average remaining lease term (years) 1.0 year Weighted-average discount rate 10 % As previously disclosed in our 2018 Annual Report on Form 10-K and under the previous lease accounting standard, ASC 840, Leases, the total commitment for non-cancelable operating leases was $ 1.9 million as of December 31, 2018 (in thousands): Lease Commitments 2019 (Remainder) $ 1,482 2020 375 Total $ 1,857 |
Debt
Debt | 3 Months Ended |
Mar. 31, 2019 | |
Debt Disclosure [Abstract] | |
Debt | Debt 2017 Term Loan On September 12, 2017, the Company entered into a term loan facility of up to $21.0 million (the “ 2017 Term Loan ”) with Silicon Valley Bank, a California corporation (“SVB”). The 2017 Term Loan is governed by a loan and security agreement, dated September 12, 2017, between the Company and SVB (the “Loan Agreement”). The 2017 Term Loan was funded in full on September 13, 2017 (the “Funding Date”). On the Funding Date, the Company entered into a payoff letter with SVB, pursuant to which SVB utilized $10.0 million of the 2017 Term Loan to pay off all outstanding obligations under the 2015 Term Loan. The Company recognized a loss on extinguishment of debt in the amount of $0.7 million during the three months ended September 30, 2017. The Company incurred less than $0.1 million in debt issuance costs in connection with the closing of the 2017 Term Loan. Debt issuance costs are presented in the consolidated balance sheet as a direct deduction from the associated liability and amortized to interest expense over the term of the related debt. The 2017 Term Loan will mature on February 1, 2022. Each advance under the 2017 Term Loan accrues interest at a floating per annum rate equal to one-half of one percent above the prime rate (as published in the money rates section of The Wall Street Journal). The 2017 Term Loan provides for interest-only payments monthly until August 31, 2019. Thereafter, amortization payments will be payable monthly in equal installments of principal and variable interest to fully amortize the outstanding principal over the remaining term of the loan. The monthly interest is subject to recalculation upon a change in the prime rate. The Company may prepay the 2017 Term Loan in full but not in part provided that the Company (i) provides five business days’ prior written notice to SVB, (ii) pays on the date of such prepayment for all outstanding principal plus accrued and unpaid interest, 2% if prepaid after the first anniversary but before the second anniversaries, and 1% if prepaid after the second anniversary. Amounts outstanding during an event of default are payable upon SVB’s demand and shall accrue interest at an additional rate of 4.0% per annum of the past due amount outstanding. The events of default under the Loan Agreement include, but are not limited to, the Company’s failure to make any payments of principal or interest under the Loan Agreement or other transaction documents, the Company’s breach or default in the performance of any covenant under the Loan Agreement or other transaction documents, the occurrence of a material adverse effect, the Company making a false or misleading representation or warranty in any material respect under the Loan Agreement, the Company’s insolvency or bankruptcy, any attachment or judgment on the Company’s assets in excess of approximately $0.3 million , or the occurrence of any default under any agreement or obligation of the Company involving indebtedness in excess of approximately $0.3 million . If an event of default occurs, SVB is entitled to take enforcement action, including acceleration of amounts due under the Loan Agreement. The 2017 Term Loan is secured by a lien on substantially all of the assets of the Company, other than intellectual property, provided that such lien on substantially all assets includes any rights to payments and proceeds from the sale, licensing or disposition of intellectual property. The Company has also granted SVB a negative pledge with respect to its intellectual property. The 2017 Term Loan does not include any financial covenants. The 2017 Term Loan requires a final payment fee of 5% on the aggregate principal amounts borrowed upon repayment at maturity, on a prepayment date, or upon default. The final payment fee totaling $1.1 million is recorded as a loan discount. Under the 2017 Term Loan , the Company is not required to maintain a minimum cash balance. In addition, the 2017 Term Loan contains a subjective acceleration clause whereby in an event of default, an immediate acceleration of repayment occurs if there is a material impairment of the lenders’ lien or the value of the collateral, a material adverse change in the business condition or operations, or a material uncertainty exists that any portion of the loan may not be repaid. The Company assessed all terms and features of the 2017 Term Loan in order to identify any potential embedded features that would require bifurcation. As part of this analysis, the Company assessed the economic characteristics and risks of the 2017 Term Loan , including any put and call features. The Company determined that all features of the 2017 Term Loan were clearly and closely associated with the debt host and did not require bifurcation as a derivative liability, or the fair value of the embedded feature was immaterial to the Company's consolidated financial statements. The Company reassesses the identified features on a quarterly basis to determine if they require bifurcation. As of March 31, 2019 and December 31, 2018 , the outstanding principal balance under the 2017 Term Loan was $21.0 million . Future minimum principal and interest payments on the 2017 Term Loan as of March 31, 2019 are as follows (in thousands): 2019 (Remainder) 4,427 2020 9,232 2021 8,718 2022 1,754 Total minimum debt payments $ 24,131 Less: Amount representing interest (2,081 ) Less: Debt discount and deferred charges (584 ) Less: Current portion of loan payable (21,466 ) Loan payable, net of current portion $ — All amounts due under the 2017 Term Loan have been classified as a current liability as of March 31, 2019 due to the considerations discussed in Note 1 and the assessment that the material adverse change clause under the 2017 Term Loan is not within the Company's control. The Company has not been notified of an event of default by SVB as of the date of the filing of this Quarterly Report on Form 10-Q . During the three months ended March 31, 2019 and 2018 , the Company recognized $0.4 million and $0.3 million |
Stockholders' Equity
Stockholders' Equity | 3 Months Ended |
Mar. 31, 2019 | |
Equity [Abstract] | |
Stockholders' Equity | 2019 Public Offering On January 25, 2019 , the Company completed a public offering of 20,000,000 shares of its common stock at a public offering price of $1.50 per share. On January 29, 2019 , an additional 2,188,706 shares were sold at a public offering price of $1.50 per share. The total net proceeds from the offering were $ 30.9 million , after deducting underwriting discounts, transaction costs and commissions. 2017 Shelf Registration Statement On August 10, 2017 , the Company filed a universal shelf registration statement on Form S-3 with the SEC to sell up to $200 million of equity and/or debt securities and entered into a sales agreement with Jefferies LLC, as sales agent, pursuant to which the Company may, from time to time, issue and sell common stock with an aggregate value of up to $50 million in an at-the-market, or ATM, offering. The shelf registration statement was declared effective by the SEC on August 28, 2017 . As of March 31, 2019 , no securities have been issued from this shelf registration statement. PIPE Financing On June 26, 2017, the Company entered into a securities purchase agreement (the "Institutional Purchase Agreement") with a select group of institutional investors (the “Institutional Investors”) and a securities purchase agreement with Timothy Springer, Ph.D., a member of the board of directors (the "Springer Purchase Agreement") for a private placement of the Company's securities (the "2017 PIPE"). The closing of the 2017 PIPE occurred on June 27, 2017. Pursuant to the Institutional Purchase Agreement, the Company agreed to sell an aggregate of 2,750,000 shares of its common stock, par value $0.0001 per share, at a purchase price equal to $16.00 per share. Pursuant to the Springer Purchase Agreement, the Company agreed to sell to Dr. Springer an aggregate of 338,791 shares of common stock at a purchase price equal to $17.71 per share, which was equal to the most recent consolidated closing bid price on the Nasdaq Global Market on June 23, 2017, and warrants to purchase up to 79,130 shares of common stock (“Warrant Shares”), exercisable at $17.71 per Warrant Share, and with a term of five years . The purchase price for each warrant was equal to $0.125 for each Warrant Share, consistent with Nasdaq Global Market requirements for an “at the market” offering. Under the terms of the Common Stock Purchase Warrant, the warrants can be settled in unregistered shares. The Warrant Shares qualify for equity classification. The fair value of the allocated proceeds was determined on the relative fair value basis. After deducting for placement agent fees and offering expenses, the aggregate net proceeds from the 2017 PIPE was approximately $47.1 million . The Company expects to use the proceeds from the 2017 PIPE towards working capital requirements and general corporate purposes. On June 27, 2017, in connection with the 2017 PIPE, the Company entered into a Registration Rights Agreement (the “Registration Rights Agreement”) with the Institutional Investors and Dr. Springer (together, the “Investors”). Pursuant to the Registration Rights Agreement, the Company agreed to prepare and file a registration statement with the SEC within 20 days after the closing of the 2017 PIPE for purposes of registering the resale of the shares of common stock issued and sold in the 2017 PIPE (the “Shares”), the Warrant Shares, and any shares of common stock issued as a dividend or other distribution with respect to the Shares or Warrant Shares. The registration statement was declared effective by the SEC on July 21, 2017. The Company agreed to indemnify the Investors, their officers, directors, members, employees and agents, successors and assigns under the registration statement from certain liabilities and to pay all fees and expenses (excluding any legal fees of the selling holder(s), and any underwriting discounts and selling commissions) incident to the Company’s obligations under the Registration Rights Agreement. Initial Public Offering On June 21, 2016, the Company completed its IPO and issued and sold 5,000,000 shares of common stock at a price to the public of $14.00 per share for net proceeds of $60.8 million after deducting underwriting discounts and commissions and offering expenses. On July 25, 2016, 289,633 additional shares of the Company’s common stock were sold to the underwriters pursuant to the exercise of their option to purchase additional shares of common stock at a price to the public of $14.00 per share resulting in additional net proceeds of approximately $3.7 million after deducting underwriting discounts, commissions and offering expenses, bringing the total IPO net proceeds to $64.5 million . Upon the closing of the Company's IPO on June 27, 2016, all outstanding shares of its convertible preferred stock automatically converted into 10,126,118 shares of the Company’s common stock. In addition, at this time, the warrants to purchase shares of the Company’s Series D and Series E convertible preferred stock were converted into warrants to purchase shares of the Company’s common stock. Common Stock As of March 31, 2019 , the Company had 200,000,000 shares of common stock authorized for issuance, $0.0001 par value per share, with 44,788,025 shares issued and outstanding. The voting, dividend and liquidation rights of the common stockholders are subject to and qualified by the rights, powers and preferences of the preferred stock. The common stock has the following characteristics: Voting The common stockholders are entitled to one vote for each share of common stock held with respect to all matters voted on by the stockholders of the Company. Dividends The common stockholders are entitled to receive dividends, if and when declared by the Board of Directors. Through March 31, 2019 , no dividends have been declared or paid on common stock. Liquidation Upon liquidation of the Company, the common stockholders are entitled to receive all assets of the Company available for distribution to such stockholders. Reserved Shares The Company has authorized shares of common stock for future issuance as follows: Period ending March 31, 2019 December 31, 2018 Exercise of common warrants 95,619 95,619 Shares available for future stock incentive awards 4,012,207 1,586,925 RSUs reserved for issuance 50,000 — Unvested restricted stock units 225,000 175,000 Outstanding common stock options 4,564,742 4,093,979 Total 8,947,568 5,951,523 |
Stock Incentive Plans
Stock Incentive Plans | 3 Months Ended |
Mar. 31, 2019 | |
Disclosure of Compensation Related Costs, Share-based Payments [Abstract] | |
Stock Incentive Plans | Stock Incentive Plans Stock Options The Company maintains the 2008 Stock Incentive Plan (the “2008 Plan”) for employees, consultants, advisors, and directors. The 2008 Plan provided for the granting of incentive and non‑qualified stock option and restricted stock awards as determined by the Board. At inception of the 2008 Plan, a total of 2,213,412 shares of common stock were authorized for grants under the 2008 Plan. The Company ceased granting awards under the 2008 Plan upon the effectiveness of the 2016 Plan (as defined below); however, awards issued under the 2008 Plan remain subject to the terms of the 2008 Plan and the applicable 2008 Plan agreement. Shares subject to awards that were granted under the 2008 Plan and that expire, lapse or terminate following the effectiveness of the 2016 Plan become available under the 2016 Plan as shares available for future grants. All unvested stock options granted under the 2008 Plan may be exercised into restricted stock subject to forfeiture upon termination prior to vesting. The 2008 Plan provided that the exercise price of incentive stock options cannot be less than 100% of the fair market value of the Company's common stock on the grant date for participants who own 10% or less of the total combined voting power of the Company, and not less than 110% for participants who own more than 10% of the Company’s voting power. Options and restricted stock awards granted under the 2008 Plan vest over periods as determined by the Board, which are generally four years and, for options, with terms that generally expire ten years from the grant date. On June 7, 2016, the Company’s stockholders approved the 2016 Incentive Award Plan (the “2016 Plan”), which became effective June 21, 2016. The 2016 Plan provides for the granting of incentive and non‑qualified stock option, restricted stock and other stock and cash-based awards as determined by the Board. Shares subject to awards that are granted under the 2016 Plan and that expire, lapse or terminate are available for future grants under the 2016 Plan. At inception of the 2016 Plan, a total of 1,210,256 shares of common stock were authorized for future issuance under the 2016 Plan. The number of shares of common stock that may be issued under the 2016 Plan automatically increases on the first day of each calendar year, beginning in 2017 and ending in and including 2026, by an amount equal to the lesser of: (i) 4% of the number of shares of the Company’s common stock outstanding on the last day of the applicable preceding calendar year and (ii) such smaller number of shares as is determined by the Board. During the three months ended March 31, 2019 and 2018, the number of shares of common stock that may be issued under the 2016 Plan was increased by 898,871 shares and 893,730 shares, respectively. As of March 31, 2019 , 1,759,539 shares remain available for future issuance under the 2016 Plan. The 2016 Plan provides that the exercise price of incentive stock options cannot be less than 100% of the fair market value of the Company's common stock on the grant date for participants who own 10% or less of the total combined voting power of the Company, and not less than 110% for participants who own more than 10% of the Company’s voting power. Options and restricted stock awards granted under the 2016 Plan vest over periods as determined by the Board, which are generally four years and, for options, with terms that generally expire ten years from the grant date. The Company’s 2018 Employment Inducement Incentive Award Plan (the “Inducement Incentive Award Plan”), which was adopted by the Board on September 25, 2018 without stockholder approval pursuant to Rule 5635(c)(4) of the Nasdaq Stock Market LLC listing rules ("Rule 5635(c)(4)"), provides for the grant of equity-based awards in the form of non-qualified stock options, stock appreciation rights, restricted stock awards, restricted stock unit awards and other stock or cash based awards. In accordance with Rule 5635(c)(4), awards under the Inducement Incentive Award Plan may only be made to a newly hired employee who has not previously been a member of the Board, or an employee who is being rehired following a bona fide period of non-employment by the Company, as a material inducement to the employee’s entering into employment with the Company. The Company reserved 1,175,000 shares of its common stock for issuance under the Inducement Incentive Award Plan. On March 25, 2019, the Board approved the amendment and restatement of the Inducement Incentive Award Plan to reserve an additional 2,000,000 shares of the Company’s common stock for issuance thereunder. On March 25, 2019, pursuant to an employment agreement entered into with Elona Kogan, the Company granted Ms. Kogan equity awards under the Inducement Incentive Award Plan consisting of an option to purchase 400,000 shares of common stock. As of March 31, 2019, there are 1,500,000 shares available for future grant under the Inducement Incentive Award Plan. The fair value of each option award was estimated on the grant date using the Black‑Scholes option pricing model. Expected volatilities are based on historical volatilities from guideline companies because the Company's common stock has not traded for a period that is at least equal to the expected term of its stock option awards. The Company uses the “simplified” method to estimate the expected life of options granted and are expected to be outstanding. The risk‑free interest rate used is the rate for a U.S. Treasury zero coupon issue with a remaining life consistent with the options expected life on the grant date. The Company has not paid and does not expect to pay in the foreseeable future, any cash dividends. Forfeitures are estimated at the time of grant and are adjusted, if necessary, in subsequent periods if actual forfeitures differ from those estimates. The Company has estimated a forfeiture rate of 10% based on historical attrition trends. The Company records stock‑based compensation expense only on awards that are expected to vest. Effective March 31, 2019, the Company entered into a transition agreement and release with an executive officer under which if he remains continuously employed by the Company through the Effective Date or the Company terminates his employment on or prior to the Effective Date without “cause”, then, subject to his continued compliance with certain restrictive covenants and execution of a general release of claims, he will be entitled to receive immediate vesting of his outstanding unvested stock options ( 60,001 shares) that would have vested based solely on his continued service if he had continued providing services to the Company until December 31, 2019 and extension of the right to exercise any vested stock options ( 137,918 shares) (after giving effect to the foregoing accelerated vesting) until March 31, 2020. The subsequent stock based compensation amount was not material. The estimated grant date fair values of employee stock option awards granted under the 2008 Plan, 2016 Plan and the Inducement Incentive Award Plan were calculated using the Black-Scholes option pricing model, based on the following weighted-average assumptions: Three Months Ended March 31, 2019 2018 Risk-free interest rate 2.45 % 2.65 % Dividend yield — — Expected term 6.06 6.64 Expected volatility 87.35 % 84.81 % Weighted-average fair value of common stock $ 2.41 $ 9.53 The weighted average grant date fair value of stock options granted to employees during the three months ended March 31, 2019 and 2018 was $1.77 and $7.07 , respectively. The aggregate intrinsic value of stock options exercised during the three months ended March 31, 2019 was $0.1 million . There were no employee stock option exercises during the three months ended March 31, 2018. As of March 31, 2019 , total unrecognized compensation expense related to unvested employee stock options was $10.3 million , which is expected to be recognized over a weighted average period of 3.1 years. No stock option awards were granted to non-employees during the three months ended March 31, 2019 and 2018. As of March 31, 2019 , total unrecognized compensation expense related to unvested non‑employee stock options was $1.0 million , which is expected to be recognized over a weighted average period of 2.0 years . The following table summarizes the activity under the 2008 Plan, 2016 Plan, and Inducement Incentive Award Plan: Weighted‑average remaining Aggregate Number of Weighted-average contractual term intrinsic value options exercise price ($) (in years) (in thousands) Employee Awards Outstanding at December 31, 2018 3,681,575 $ 9.49 7.77 $ 300 Granted 1,319,500 $ 2.41 Exercised (115,600 ) $ 1.26 Forfeited (733,137 ) $ 10.51 Outstanding at March 31, 2019 4,152,338 $ 7.29 8.53 $ 195 Vested at March 31, 2019 1,071,591 $ 10.06 5.98 $ 107 Vested and expected to vest at March 31, 2019 3,893,328 $ 7.39 8.47 $ 189 Non‑Employee Awards Outstanding at December 31, 2018 412,404 $ 6.44 6.42 $ 28 Granted — $ — Exercised — $ — Forfeited — $ — Outstanding at March 31, 2019 412,404 $ 6.44 6.18 $ 24 Vested at March 31, 2019 227,986 $ 4.21 3.73 $ 24 Vested and expected to vest at March 31, 2019 412,404 $ 6.44 6.18 $ 24 Restricted Stock Units During the fourth quarter of 2018, the Company awarded 175,000 restricted stock units under the Inducement Incentive Award Plan. The restricted stock units granted had a weighted average fair value of $6.03 per share based on the closing price of the Company’s common stock on the date of grant. These restricted stock units were valued at approximately $ 1.1 million . During the first quarter of 2019, the Company awarded 100,000 restricted stock units under the Inducement Incentive Award Plan, of which 50,000 were determined to be granted as of the award date consistent with ASC 718. The remaining 50,000 restricted stock units do not have a defined performance metric as of the award date, resulting in the restricted stock units being reserved for future issuance as of March 31, 2019. These restricted stock units will vest in two equal installments on the dates an applicable performance condition is achieved, on or prior to December 31, 2020. If the performance conditions are not satisfied on or prior to December 31, 2020, the restricted stock units will be forfeited for no consideration. The restricted stock units granted had a weighted average fair value of $ 2.29 per share based on the closing price of the Company’s common stock on the date of grant. The restricted stock units were valued at approximately $ 0.1 million on their grant date. Unrecognized compensation expense is $ 1.1 million as of March 31, 2019 , which is expected to be recognized over a weighted average period of 3.4 years . The following table summarizes the status of the Company’s restricted stock units: Number of Shares (#) Weighted Average Fair Value ($) Unvested at December 31, 2018 175,000 $ 6.03 Granted 50,000 2.29 Vested — — Reserved for issuance 50,000 — Forfeited — — Unvested at March 31, 2019 275,000 $ 5.20 Employee Stock Purchase Plan On June 7, 2016, the Company’s stockholders approved the 2016 Employee Stock Purchase Plan (the “ESPP”), which became effective June 21, 2016. The ESPP is intended to qualify as an "employee stock purchase plan" under Section 423 of the Internal Revenue Code of 1986 with the purpose of providing employees with an opportunity to purchase the Company's common stock through accumulated payroll deductions. Under the ESPP, the Company has set two six-month offering periods during each calendar year, one beginning March 1 st and the other beginning September 1 st of each calendar year, during which employees may elect to have up to 25% of their eligible compensation deducted on each payday on an after-tax basis for use in purchasing the Company's common stock on the last trading day of each offering period, subject to limits imposed by the Internal Revenue Code. The purchase price of the shares may not be less than 85% of the fair market value on the first or last trading day of the offering period, whichever is lower. The first ESPP offering period began on March 1, 2017. At inception of the ESPP, a total of 173,076 shares of common stock were authorized and reserved for future issuance under the ESPP. The number of shares of common stock that may be issued under the ESPP will automatically increase on the first day of each calendar year, beginning in 2017 and ending in and including 2026, by an amount equal to the lesser of: (i) 1% of the number of shares of the Company’s common stock outstanding on the last day of the applicable preceding calendar year and (ii) such smaller number of shares as is determined by the Company’s Board of Directors. During the three months ended March 31, 2019 and 2018 , the number of shares of common stock that may be issued under the ESPP was increased by 224,717 shares and 223,432 shares, respectively. During the three months ended March 31, 2019 , the Company issued 11,943 shares of common stock under the ESPP. As of March 31, 2019 , 752,668 shares remain available for future issuance under the ESPP. For each of the three months ended March 31, 2019 and 2018 , the Company recognized less than $0.1 million of stock-based compensation expense under the ESPP. The Company recorded stock-based compensation expense related to stock option awards, restricted stock units and the ESPP in the following expense categories of its consolidated statements of operations and comprehensive loss (in thousands): Three Months Ended March 31, 2019 2018 Research and development $ 519 $ 511 General and administrative 661 642 Total stock-based compensation expense $ 1,180 $ 1,153 |
Revenue Arrangements
Revenue Arrangements | 3 Months Ended |
Mar. 31, 2019 | |
Revenue from Contract with Customer [Abstract] | |
Revenue Arrangements | Revenue Arrangements Spark Therapeutics, Inc. Spark License Agreement In December 2016, the Company entered into a License and Option Agreement (“Spark License Agreement”) with Spark Therapeutics, Inc. (“Spark”) pursuant to which the Company and Spark agreed to collaborate on the development of gene therapies for certain targets utilizing the ImmTOR technology. The Spark License Agreement provides Spark with certain exclusive, worldwide, royalty bearing licenses to the Company’s intellectual property, allowing Spark to develop and commercialize gene therapies for an initial identified target. In addition to an upfront cash payment of $10.0 million under the Spark License Agreement, additional payments of an aggregate of $5.0 million in two payments of $2.5 million each were paid within twelve months of December 2, 2016 (“Contract Date”). The first of the two additional payments was scheduled to be made on or before May 31, 2017 (the “May 2017 License Payment”) (see “Spark Letter Agreement” below) and the second was made on October 31, 2017. Spark may also exercise options to research, develop and commercialize gene therapies utilizing the SVP technology for up to four additional targets. The Company is eligible to receive a variable fee up to $2.0 million for each additional target option elected, dependent on the incidence of the applicable indication. As per the agreement, the election period in which Spark can exercise additional targets is a term of three years from the Contract Date, or December 1, 2019. Assuming successful development and commercialization, the Company could receive up to an additional $65.0 million in development and regulatory milestone payments and $365.0 million in commercialization milestone payments for each indication. If commercialized, the Company would be eligible to receive tiered royalties on global net sales at percentages ranging from mid-single to low-double digits, all of which apply on a target-by-target basis. Under the terms of the agreement, the Company will be eligible to receive these royalties commencing on the first commercial sale of the licensed product and terminating upon the later of (i) ten years after the first commercial sale, (ii) expiration of the last to expire valid claim on patents covering the jointly invented field specific improvements, or (iii) the expiration of regulatory exclusivity in the applicable country for the licensed product. The Spark License Agreement may be terminated by Spark for convenience upon ninety days ’ notice. Either party may terminate the Spark License Agreement on a target-by-target basis for material breach with respect to such target. In December 2016, the Company also entered into a Share Purchase Agreement (the “Spark Purchase Agreement”) with Spark. Pursuant to the Spark Purchase Agreement, the Company sold 197,238 shares of the Company’s common stock to Spark for gross proceeds of $5.0 million , or $25.35 per share of common stock, at an initial closing (the “Initial Closing”). The purchase price per share represents an amount equal to 115% of the average daily volume weighted average price (“VWAP”) of the common stock during the thirty consecutive calendar days leading up to and ending on the day prior to the Contract Date. Under the Spark Purchase Agreement, Spark has agreed not to dispose of any of the Initial Closing Shares or any Acquisition Right Shares that it may acquire until January 1, 2018 and, thereafter, transfers will be contractually subject to volume limitations applicable to an “affiliate” under Rule 144 of the Securities Act. Closings under the Spark Purchase Agreement are subject to customary conditions. Beyond the Initial Closing, the Spark Purchase Agreement contemplated potential future sales of shares by the Company to Spark as follows: • First Acquisition Right. During the period beginning on May 1, 2017 and ending on June 1, 2017, Spark had the right (the “First Acquisition Right”) to purchase a number of shares of common stock equal to an aggregate price of $5.0 million . See "Spark Letter Agreement" below. • Second Acquisition Right. During the period beginning on October 1, 2017 and ending on November 1, 2017, Spark had the right (the “Second Acquisition Right”) to purchase a number of shares of common stock equal to an aggregate price of $5.0 million . On October 31, 2017 Spark exercised this right and purchased 205,254 shares of common stock from the Company for $5.0 million , or $24.36 per share of common stock. The purchase price per share represents an amount equal to 115.0% of the average daily VWAP of the common stock during the thirty consecutive calendar days leading up to and ending on the day prior to the Second Acquisition Right notification date. The First Acquisition Rights and Second Acquisition Rights are collectively referred to herein as the “Acquisition Rights”. The aggregate number of shares that the Company may issue pursuant to the Stock Purchase Agreement may not exceed the lesser of (i) 2,758,112 shares and (ii) such number of shares that would require the Company to obtain prior shareholder approval under the Nasdaq Marketplace Rules. In connection with the Spark License Agreement and Spark Purchase Agreement, the Company has made contractual payments defined in the MIT license agreement (Note 15) totaling $2.2 million for the MIT sub-license provided to Spark, and $0.4 million relative to the calculated premium paid by Spark for the equity investments made under the Spark Purchase Agreement. The terms of the Spark Purchase Agreement and the Spark License Agreement were negotiated at the same time between the parties and the terms of the Spark Purchase Agreement are referenced in the Spark License Agreement in multiple sections. The pricing and terms of the agreements are unique and must be considered in contemplation with each other. There are provisions within the Spark License Agreement that link to the Spark Purchase Agreement related to provisions that constitute a material breach of the license agreement. Therefore, the Company concluded that the two agreements must be combined and evaluated as a single agreement. While the Spark Purchase Agreement and the Spark License agreement are considered to be a single agreement, the Company determined that the purchase of common stock and future acquisition rights are not within the scope of ASC 606. The Company determined that the initial purchase of common stock combined with the embedded future stock Acquisition Rights had a fair value of $2.7 million and this amount was recorded in equity as of the effective date. The remaining $2.3 million of cash received in exchange for the stock and acquisition rights is included in allocable consideration, as this represents the premium paid by Spark on the purchase of common stock, and should be allocated to the remaining performance obligations. The Company identified the following promises at the inception of the agreement: (1) certain exclusive, worldwide, royalty bearing licenses to the Company’s intellectual property and a license to conduct certain research activities under the collaboration, or the License Obligation, (2) options to research, develop and commercialize gene therapies utilizing the ImmTOR technology for up to four additional target therapy options, or the Option Obligation, (3) manufactured supply of preclinical and clinical SVP, or the Supply Obligation at a discount, and (4) option to purchase manufactured supply of commercial SVP, or the Commercial Supply Obligation at fair value. In consideration for these promises, the Company received an upfront payment of $15.0 million . In addition, the Company is eligible to receive additional payments of up to $35.0 million based on the achievement by Spark of future specified development milestones, up to $30.0 million based on the achievement by Spark of future specified regulatory milestones, up to $110.0 million based on the achievement by Spark of future specified commercial milestones, and up to $255.0 million based on the achievement by Spark of future specified sales milestones. The Company will also be eligible to receive tiered royalty payments that reach low double-digits based on future net sales for the duration of the royalty term. The Company determined that the License Obligation was not capable of being distinct from the Supply Obligation. This is because Spark cannot derive benefit from the license without the simultaneous transfer of the preclinical and clinical supply. Therefore, the License Obligation and Supply Obligation are combined as a single performance obligation (the “Combined License and Supply Obligation”). The Company also determined that the Option Obligation, which includes the related Supply Obligation, provides the customer with a material right and is considered a performance obligation in the arrangement since it was priced at an incremental discount. The Company determined that the optional Commercial Supply Obligation does not provide the customer with a material right and is not considered to be a performance obligation because Spark can derive benefit from the Combined License and Supply Obligation without the delivery of the Commercial Supply Obligation and is not at an incremental discount. Therefore, the Company determined that the Spark agreement contains five distinct performance obligations: the Combined License and Supply Obligation, and the four separate Option Obligations. In determining the transaction price, the Company considered the future development milestones, regulatory milestones, commercial milestones, sales milestone, and sales royalties all represent variable consideration. Each of these variable consideration items was evaluated under the most likely amount method to determine whether such amounts were probable of occurrence, or whether such amounts should be constrained until they become probable. As part of its evaluation of the constraint, the Company considered numerous factors, including that receipt of such milestones is outside the control of the Company. Separately, any consideration related to sales-based milestones as well as royalties on net sales upon commercialization by Spark, will be recognized when the related sales occur as they were determined to relate predominantly to the intellectual property granted to Spark and, therefore, have also been excluded from the transaction price in accordance with the royalty recognition constraint. As of March 31, 2019 , all milestones were constrained. The Company will re-evaluate the transaction price in each reporting period, as uncertain events are resolved, or as other changes in circumstances occur. The Company determined that the up-front payment of $12.3 million ( $15.0 million , less fair value of the equity totaling $2.7 million as discussed above) was included in the transaction price and was allocated to the performance obligations based on the Company’s best estimate of their relative stand-alone selling prices. The Company allocated $7.1 million to the Combined License and Supply Obligation and $5.2 million to the discount on the Option Obligation ( $1.3 million for each option) using the relative standalone selling price method to each obligation. The standalone selling price for the Combined License and Supply Obligation was determined using a discounted cash flow model. The standalone selling price for the Option Obligation was determined based on the fair value of the license minus the strike price of the option (the probability of exercise was included in the valuation) as well as the estimated discount of the Supply Obligation. The estimated proceeds to be received from the sale of the Supply Obligation was also included in the transaction price for the Combined License and Supply Obligation. The total consideration allocated to the Combined License and Supply Obligation will be recognized using the output method, based on the proportion of actual deliveries to the total expected deliveries over the initial term which is estimated to be approximately four years . The discount associated with the Option Obligation, along with the proceeds to be received upon exercise and estimated sale of the Supply Obligation, will be recognized when each of the options are exercised, over the related expected deliveries of its supply. If the options expire without exercise, the related deferred revenue associated with each option will be recognized upon expiration (December 1, 2019). The Company recognized other assets of $2.6 million related to the incremental costs relating to the payments to MIT that would not have been incurred if the contract with Spark had not been obtained. Under the Company existing license agreement with MIT (See Note 15), in the event the Company sublicenses the MIT patents to a third party, it will be required to remit to MIT a percentage (ranging from 10% to 30% ) of sublicense income. The Company concluded that the payments made to MIT were analogous to sales commissions and represented the cost to obtain a contract, which were evaluated under ASC 340-40-25-1. Such amounts were capitalized as they were both incremental and recoverable. However, upon further review, the Company noted that the amounts paid to MIT represent the cost to fulfill a contract rather than a cost to obtain a contract as they represent the costs that were incurred in order to fulfill their supply obligations under the Spark License Agreement. Therefore, the incremental payments to MIT represent part of the cost to fulfill the contract. When determining the appropriate accounting guidance for the costs to fulfill a customer contract, ASC 340-40-25-6 indicates that any other applicable literature should be considered first. Since the intellectual property is being used exclusively for research and development, the accounting for the MIT costs were previously accounted for under ASC 730-10. Since all of the payments to MIT related to the underlying intellectual property, that does not have alternative future use, such amounts should not have been capitalized, and instead remained recorded as research and development expense. The Company evaluated the impact of the error on previously issued financial statements included in the Form 10-Q for the quarters ended March 31, 2018, June 30, 2018 and September 30, 2018, noting that the impact was not material to the balance sheet, statement of operations or cash flows. However, correcting the error would be material to the quarterly trends in the statement of operations to expense the amount in the fourth quarter. Therefore, such amounts were corrected by reducing current and long-term assets by $0.2 million and $2.4 million , respectively and increasing accumulated deficit by $2.6 million as of January 1, 2018 by reversing the amounts initially recorded in transition as is shown in the first quarter 2018 Stockholders' Equity (Deficit) statement. There was no impact to the consolidated statements of operations or cash flows for any of the quarters previously filed and no impact to any of the previously issued annual financial statements. During the three months ended March 31, 2019 , there was one delivery resulting in less than $0.1 million of revenue recognized. No revenue related to the Spark License Agreement was recognized during the twelve months ended December 31, 2018. As of March 31, 2019 , there was a contract liability of $14.7 million representing deferred revenue associated with this agreement. A total of $1.0 million is presented as current and $13.7 million is presented as noncurrent in the accompanying consolidated balance sheet. As of December 31, 2018 , there was $14.7 million of deferred revenue related to this agreement. Spark Letter Agreement On June 6, 2017, the Company and Spark entered into a letter agreement (the “Letter Agreement”), pursuant to which the parties agreed that Spark would make the May 2017 License Payment by June 6, 2017. The May 2017 License Payment was received, and recorded as a liability as of June 30, 2017, of which some or all may potentially constitute the reimbursement described below. The parties also agreed that Spark would be deemed to have delivered notice on May 31, 2017 exercising its right to purchase the shares pursuant to the First Acquisition Right. The Letter Agreement further outlines a cost reimbursement arrangement, pursuant to which the Company agreed to reimburse Spark for all costs and expenses, including the cost of materials provided by the Company, associated with the preclinical research and toxicology studies being performed by Spark for any licensed products for a specified amount of time (the “Reimbursement Period”), up to an agreed upon cap of $2.5 million . Consistent with the First Acquisition Right, Spark purchased 324,362 shares of common stock pursuant to the Spark Purchase Agreement, as amended by the Letter Agreement, for an aggregate purchase price of $5.0 million , or $15.41 per share of common stock. The purchase price per share represents an amount equal to 115.0% of the average daily volume weighted average price (“VWAP”) of the common stock during the thirty consecutive calendar days leading up to and ending on the day prior to the First Acquisition Right notification date. At the initial contract assessment, the Company allocated $2.7 million to equity (representing the fair value of the initial purchase of common stock combined with the embedded future stock Acquisition Rights). Upon exercise of the First Acquisition Right, the Company recorded the purchase amount to stockholders ’ equity. The Company determined that the Letter Agreement resulted in a modification to the original agreement. The amount received totaling $2.5 million and the reimbursements pursuant to the Letter Agreement totaling $2.5 million were both included in the transaction price, and a liability was recorded for the amount expected to be repaid. As repayments are made, the underlying liability will be reduced. To the extent that an amount is expected to be applied towards the clinical supply obligation, the analysis of variable consideration will be updated accordingly. On October 31, 2017, Spark paid the Company a $2.5 million milestone payment pursuant to the Spark License Agreement, which was included in the transaction price and allocated to the performance obligations using the relative standalone selling price. In addition, Spark exercised the Second Acquisition Right set forth in Section 2.4 of the Spark Purchase Agreement and purchased 205,254 shares of common stock from the Company for $5.0 million , or $24.36 per share of common stock. The purchase price per share represents an amount equal to 115.0% of the average daily VWAP of the common stock during the thirty consecutive calendar days leading up to and ending on the day prior to the Second Acquisition Right notification date. Skolkovo Foundation The Company receives grant funding from the Russia-based Development Fund of New Technologies Development and Commercialization Center ("Skolkovo"). On November 28, 2014, the Company executed a grant awarded by Skolkovo for the development of a therapeutic vaccine using nanoparticles to treat chronic infection caused by human papillomavirus (HPV) and diseases associated with this infection. The grant covered the period from August 1, 2014 through July 21, 2017. The grant provided for up to $2.7 million that covers 48.5% of the estimated total cost of the research plan with the remaining 51.5% of estimated costs to be contributed by the Company. From grant inception through March 31, 2019 , the Company received $2.0 million from Skolkovo. At any time during the term of the grant agreement, but not more than once per quarter, Skolkovo has the right to request information related to the project and to conduct an audit of the expenses incurred by the Company. In the event the project or the expenses do not meet predefined requirements, the Company may be required to reimburse the funds received up to three years after the completion of the project. As a result, in accordance with ASC 605, the Company determined that the grant funding was not fixed or determinable and the entire amount received through December 31, 2017 was recorded as deferred revenue in the consolidated balance sheet until the completion of the Skolkovo audit or the expiration of the audit term, which is expected April 2021. In accordance with ASC 606, the contract counterparty, Skolkovo, is a customer. Furthermore, the agreement with Skolkovo has commercial substance, and that the grant should be accounted for as revenue. The Company identified the research and development services being provided to Skolkovo as the only performance obligation in the agreement. Based on the guidance in ASC 606, the Company concluded that the entire $2.0 million of grant funds received from Skolkovo is variable consideration. Although the Company believes it has an enforceable right to the amounts received, there is risk that an audit could result in the Company needing to refund certain amounts back to Skolkovo, resulting in variability in the transaction price. The Company utilized the “expected value” approach in determining the amount that can be recognized. The Company estimated that it will be entitled to revenue of $1.8 million from the Skolkovo grant, and recorded this amount. The remainder of $0.2 million was recorded as a contract liability. During the year ended December 31, 2018, the Company made a decision to cease work relating to the Skolkovo grant. As a result, Skolkovo performed a formal review of project expenses incurred by the Company. Skolkovo concluded that the Company should (i) return unused grant funds to Skolkovo in the amount of less than $0.1 million and (ii) reimburse $0.1 million of costs deemed to have been overspent relative to the cost share requirement stipulated in the grant. As of March 31, 2019 , a contract liability of $0.1 million remains on the balance sheet and will not be recognized as revenue until the expiration of the three-year audit period, or sooner, if resolution is reached with Skolkovo or there is a change in the estimate. National Institutes of Health On May 14, 2014, the National Institute on Drug Abuse (“NIDA”), part of the National Institutes of Health ("NIH"), provided the Company with a Notice of Award (“NoA”), for a grant relating to the preclinical development and clinical proof of concept for a synthetic nanoparticle (the “Project”). The grant will help advance the Company’s development of the nanoparticle from a preclinical through early clinical stage and will provide support for one or more clinical trials. Under the terms of the grant, NIDA agreed to provide up to $8.1 million in funding to be used to offset the qualifying expenses incurred by the Company. The grant was to be funded over the course of three years , according to budget forecasts prepared by the Company. According to ASC 606, the contract counterparty, NIDA, is a customer. Furthermore, the agreement with NIDA has commercial substance, and the grant should be accounted for as revenue. The Company identified the research and development services being provided to NIDA as the only performance obligation in the agreement. Through December 31, 2017, the Company recognized $7.2 million of grant revenue. During the fourth quarter of 2018, the Company recognized $0.9 million of grant revenue from NIDA. Transaction Price Allocated to Future Performance Obligations Remaining performance obligations represent the transaction price of contracts for which work has not been performed (or has been partially performed) and excludes unexercised contract options. As of March 31, 2019 , the aggregate amount of the transaction price allocated to remaining performance obligations was $8.6 million . The Company expects to recognize revenue on approximately 8.9% of the remaining performance obligations over the next 12 months. Contract Balances from Contracts with Customers The following table presents changes in the Company’s contract liabilities during the three months ended March 31, 2019 (in thousands): Balance at Balance at Beginning of Period Additions Deductions End of Period Three Months Ended March 31, 2019 Contract liabilities: Deferred revenue $ 14,777 $ 8 $ (10 ) $ 14,775 Other liabilities (i) 2,126 — (493 ) 1,633 Total contract liabilities $ 16,903 $ 8 $ (503 ) $ 16,408 (i) As of March 31, 2019 , the current portion of other liabilities in the amount of $0.8 million is presented in the accrued expenses line of the consolidated balance sheet. The non-current portion of other liabilities in the amount of $0.8 million is presented in the other long-term liabilities line of the consolidated balance sheet. Deferred revenue During the three months ended March 31, 2019, the Company recognized less than $0.1 million of revenue for a shipment to Spark. During the year ended December 31, 2018, the Company made a decision to cease work relating to the Skolkovo grant. As a result, Skolkovo performed a formal review of project expenses incurred by the Company. Skolkovo concluded that the Company should return unused grant funds to Skolkovo, which resulted in a reduction to deferred revenue of less than $0.1 million . Other liabilities In connection with its cost reimbursement arrangement with Spark, the Company received and paid reimbursement invoices during the three months ended March 31, 2019 amounting to approximately $0.5 million , which reduced the other liability balance to $1.6 million as of March 31, 2019 . |
Related-Party Transactions
Related-Party Transactions | 3 Months Ended |
Mar. 31, 2019 | |
Related Party Transactions [Abstract] | |
Related-Party Transactions | Related‑Party Transactions In January 2019, the Company completed a registered public offering pursuant to which we issued and sold an aggregate of 22,188,706 shares of our common stock (including 2,188,706 shares sold pursuant to the underwriters’ full exercise of their option to purchase additional shares) at a public offering price of $1.50 for aggregate gross proceeds to us of approximately $ 33.3 million . The following table sets forth the number of shares of common stock purchased in our registered public offering by directors (and related parties thereto) and holders of more than 5% of our common stock: Name Shares of Common Total Timothy A. Springer, Ph.D. 4,000,000 $ 6,000,000.00 Entities affiliated with NanoDimension 1,666,666 $ 2,499,999.00 Entities affiliated with OrbiMed Advisors 1,333,333 $ 1,999,999.50 Entities affiliated with Polaris 666,666 $ 999,999.00 SAF-BND Trust (affiliate of Omid Farokhzad, M.D.) 83,333 $ 124,999.50 Chafen Lu (Timothy Springer’s wife) 66,666 $ 99,999.00 Jed Springer (Timothy Springer’s brother) 1,000 $ 1,500.00 During the fourth quarter of 2018, the Company entered into an amended consulting agreement with Dr. Omid Farokhzad, a member of its Board of Directors. The term of the amendment to the Consulting Agreement is April 1, 2018 to December 31, 2019, which extends the original consulting term for an additional nine months from March 31, 2019. Compensation for the Amendment includes a $85,000 payment for the period beginning January 1, 2019 and ending December 31, 2019. The $85,000 will be paid quarterly across the contract term in arrears beginning March 31, 2019. Included within this agreement, a stock option award of 75,000 shares was granted, with a weighted average grant date fair value of $4.35 . The Company incurred expenses for consulting services provided by its founders totaling $0.1 million , and less than $0.1 million during the three months ended March 31, 2019 , and 2018 |
Technology License Agreements
Technology License Agreements | 3 Months Ended |
Mar. 31, 2019 | |
Goodwill and Intangible Assets Disclosure [Abstract] | |
Technology License Agreements | Technology License Agreements Massachusetts Institute of Technology On November 25, 2008, the Company entered into an Exclusive Patent License agreement with the Massachusetts Institute of Technology (“MIT”), which is referred to as the Exclusive Patent License. The Company received an exclusive royalty‑bearing license to utilize patents held by MIT in exchange for upfront consideration and annual license maintenance fees. Such fees are expensed as incurred and have not been material to any period presented. In the event the Company sublicenses the MIT patents to a third party, it will be required to remit to MIT a percentage (ranging from 10% to 30% ) of sublicense income. In addition, the Company is obligated to pay MIT a certain amount upon the achievement of defined clinical milestones, up to a total of $1.5 million . On December 18, 2008, the Company entered into a patent‑cross‑license agreement with BIND Therapeutics, Inc. whereby each party receives a license for the use of the other patents in their respective fields of use. In exchange for this license, the Company paid a one‑time expense in 2008. As of March 31, 2019 , and in connection with the execution of the Spark License Agreement, the Company has made contractual payments pursuant to the Exclusive Patent License totaling $2.2 million for the sublicense granted to Spark, and $0.4 million relative to the calculated premium paid by Spark for the equity investments made under the Spark Purchase Agreement. The Company made no additional payments during the three months ended March 31, 2019 . Shenyang Sunshine Pharmaceutical Co., Ltd In May 2014, the Company entered into a license agreement with Shenyang Sunshine Pharmaceutical Co., Ltd. (“3SBio”), which is referred to as the 3SBio License. Pursuant to the 3SBio License, which was amended and restated in May 2017, the Company was granted an exclusive license to certain pegadricase (formerly pegsiticase)‑related patents and related “know‑how” owned or in‑licensed by 3SBio for the worldwide (except for Greater China and Japan) development and commercialization of products based thereupon for human therapeutic, diagnostic and prophylactic use. Pegadricase is the new United States Adopted Name (USAN) for pegsiticase. The Company was also granted a worldwide (except for Greater China) exclusive license to develop, commercialize and manufacture or have manufactured products combining the Company’s proprietary ImmTOR technology with pegadricase or related compounds supplied by 3SBio (or otherwise supplied if the Company’s rights to manufacture are in effect) for human therapeutic, diagnostic and prophylactic use. The Company was also granted a co‑exclusive license to manufacture and have manufactured pegadricase and related compounds for preclinical and clinical use or, if the 3SBio License is terminated for 3SBio’s material breach, for any use under the 3SBio License. Otherwise, the Company is obligated to obtain all of its supply of such compounds for Phase 3 clinical trials and commercial use from 3SBio under the terms of supply agreements to be negotiated. Pursuant to the 3SBio License, the Company is required to use commercially reasonable efforts to develop and commercialize a product containing pegadricase or a related compound. If the Company does not commercialize any such product in a particular country in Asia, Africa or South America within 48 months after approval of any such product in the United States or a major European country, then 3SBio will have the right to do so, but only until the Company commercializes a product combining the Company’s ImmTOR technology with any such compound in such country. The Company has paid to 3SBio an aggregate of $3.0 million in upfront and milestone‑based payments under the 3SBio License. The Company is required to make future payments to 3SBio contingent upon the occurrence of events related to the achievement of clinical and regulatory approval milestones of up to an aggregate of $21.0 million for products containing the Company’s ImmTOR technology, and up to an aggregate of $41.5 million for products without the Company’s ImmTOR technology. The Company is also required to pay 3SBio tiered royalties on annual worldwide net sales (on a country‑by‑country and product‑by‑product basis) related to the pegadricase component of products at percentages ranging from the low‑to‑mid single digits for products containing the Company’s ImmTOR technology, and a range of no more than ten percent points from the mid‑single digits to low double‑digits for products without the Company’s ImmTOR technology. The Company will pay these royalties to 3SBio, subject to specified reductions, on a country‑by‑country and product‑by‑product basis until the later of (i) the date that all of the patent rights for that product have expired in that country, or (ii) a specified number of years from the first commercial sale of such product in such country. The 3SBio License expires on the date of expiration of all of the Company’s royalty payment obligations unless earlier terminated by either party for an uncured material default or for the other party’s bankruptcy. Any such termination by 3SBio for material default may be on a country‑by‑country or product‑by‑product basis in certain circumstances. The Company may also terminate the 3SBio License on a country‑by‑country or product‑by‑product basis for any reason effective upon 60 days’ prior written notice to 3SBio or, with respect to a given product, immediately upon written notice to 3SBio if the Company identifies a safety or efficacy concern related to such product. Massachusetts Eye and Ear Infirmary and The Schepens Eye Research Institute, Inc. In May 2016, the Company entered into a license agreement with the Massachusetts Eye and Ear Infirmary and The Schepens Eye Research Institute, Inc. (collectively, “MEE”), which is referred to as the MEE License. Under the MEE License, the Company was granted an exclusive commercial worldwide license, with the right to grant sublicenses through multiple tiers, to make, have made, use, offer to sell, sell and import certain products and to practice certain processes, the sale, use or practice of which are covered by patents and proprietary know‑how owned or controlled by MEE, for use of Anc80 gene therapy vectors for gene augmentation therapies expressing certain target sequences. MEE also granted the Company exclusive options to exclusively license certain of their intellectual property rights relating to several additional target sequences and variations thereof each linked to a specified disease. During a defined option period, the Company may exercise this right for up to a designated number of target sequences. If the Company exercises its options, under certain circumstances, the Company may substitute alternative target sequences for previously selected target sequences. The Company agreed to use commercially reasonable efforts to develop and commercialize licensed products pursuant to a development plan, and to market and sell at least one product for each target sequence for which the Company exercised its option as soon as reasonably practicable. Subject to certain exceptions, following commercial launch, the Company must use commercially reasonable efforts to market, sell, and maintain public availability of licensed products in a certain number of specified major markets. Pursuant to the MEE License, the Company agreed to pay MEE a license fee in the low six figures, annual license maintenance fees ranging from the mid‑twenty thousands to mid‑seventy thousands and an option maintenance fee in the low five figures for each exercisable option. The Company also agreed to reimburse MEE for a specified percentage of the past patent expenses for the patents licensed to the Company. The Company also agreed to pay development milestones on a licensed product‑by‑licensed product basis, totaling up to an aggregate of between $4.2 million to $37.0 million and sales milestones on a licensed product‑by‑licensed product basis, totaling up to an aggregate of between $50.0 million to $70.0 million ; tiered royalties on a licensed product‑by‑licensed product and country‑by‑country basis equal to a percentage of net sales ranging from mid‑single digits to mid‑teens, subject to the prevalence of the targeted disease and certain reductions; and a percentage, in a range expected to be in the mid‑teens depending on timing, of any sublicense income the Company receives from sublicensing its rights granted thereunder, subject to certain reductions and exclusions. Upon exercise of each option, the Company agreed to pay MEE an option exercise fee ranging from low‑six figures to mid‑six figures, depending on the prevalence of the targeted disease. The MEE License will continue until the expiration of the last to expire of the patent rights licensed thereunder. The Company may terminate the MEE License in whole or in part upon prior written notice. MEE may terminate the MEE License on a target sequence‑by‑target sequence basis if the Company fails to make any scheduled payments in respect of such target sequence or if the Company materially breaches a diligence obligation in respect of such target sequence, in each case if the Company fails to cure within a specified time period. MEE may terminate the MEE License in its entirety if the Company materially breaches certain of its obligations related to diligence, representations and warranties, and maintenance of insurance; if the Company challenges the validity or enforceability of any patents licensed thereunder; if any of the Company’s executive officers are convicted of a felony relating to manufacture, use, sale or importation of licensed products; or upon the Company’s insolvency or bankruptcy. Through March 31, 2019 , the Company paid a total of $0.4 million in license fees due under the MEE License. No license fees are accrued under the MEE License as of March 31, 2019 |
Income Taxes
Income Taxes | 3 Months Ended |
Mar. 31, 2019 | |
Income Tax Disclosure [Abstract] | |
Income Taxes | Income Taxes The Company provides for income taxes under ASC 740. Under ASC 740, the Company provides deferred tax assets and liabilities for the expected future tax consequences of temporary differences between the Company’s financial statement carrying amounts and the tax bases of assets and liabilities using enacted tax rates expected to be in effect in the years in which the differences are expected to reverse. For the three months ended March 31, 2019 and 2018 , the Company did not record a current or deferred income tax expense or benefit. The Company has provided a full valuation allowance against its net deferred tax assets, as the Company believes that it is more likely than not that the deferred tax assets will not be realized. Utilization of the net operating loss and research and development credit carryforwards may be subject to a substantial annual limitation under Section 382 and 383 of the Internal Revenue Code due to ownership change limitations that have occurred previously, or that could occur in the future. These ownership changes may limit the amount of net operating loss and research and development credit carryforwards that can be utilized annually to offset future taxable income and tax, respectively. In January 2019, the Company completed an equity offering that it believes will result in an ownership change under Section 382 of the Internal Revenue Code. Based upon estimates, the Company believes that deferred tax assets of $49.5 million , related to federal and Massachusetts net operating losses and credits, will no longer be available going forward. Such amounts are offset by a full valuation allowance at December 31, 2018. The Company will finalize this calculation in 2019. The Company applies ASC 740 to uncertain tax positions. As of the adoption date of January 1, 2010 and through March 31, 2019 , the Company had no unrecognized tax benefits or related interest and penalties accrued. Interest and penalty charges, if any, related to unrecognized tax benefits would be classified as income tax expense in the accompanying statement of operations. The Company has not, as of yet, conducted a study of its research and development credit carryforwards. This study may result in an adjustment to the Company’s research and development credit carryforwards; however, until a study is completed and any adjustment is known, no amounts are being presented as an uncertain tax position. A full valuation allowance has been provided against the Company’s research and development credits and, if an adjustment is required, this adjustment would be offset by an adjustment to the valuation allowance. As a result, there would be no impact to the consolidated balance sheets, statements of operations and comprehensive loss, or cash flows if an adjustment was required. |
Defined Contribution Plan
Defined Contribution Plan | 3 Months Ended |
Mar. 31, 2019 | |
Retirement Benefits [Abstract] | |
Defined Contribution Plan | Defined Contribution Plan The Company maintains a defined contribution plan under Section 401(k) of the Internal Revenue Code (the “401(k) Plan”). The 401(k) Plan covers all employees who meet defined minimum age and service requirements, and allows participants to defer a portion of their annual compensation on a pretax basis. The 401(k) Plan provides for matching contributions on a portion of participant contributions pursuant to the 401(k) Plan’s matching formula. All matching contributions vest ratably over 4 years and participant contributions vest immediately. Contributions by the Company totaled less than $0.1 million during each of the three months ended March 31, 2019 and 2018 |
Commitments and Contingencies
Commitments and Contingencies | 3 Months Ended |
Mar. 31, 2019 | |
Commitments and Contingencies Disclosure [Abstract] | |
Commitments and Contingencies | Commitments and Contingencies As of March 31, 2019 , the Company had operating lease agreements for offices in Watertown, MA, see Note 9 to the condensed consolidated financial statements for additional information regarding the Company's leases. Other As permitted under Delaware law, the Company indemnifies its directors for certain events or occurrences while the director is, or was, serving at the Company’s request in such capacity. The term of the indemnification is for the director’s lifetime. The maximum potential amount of future payments the Company could be required to make is unlimited; however, the Company has directors’ insurance coverage that limits its exposure and enables it to recover a portion of any future amounts paid. The Company also has indemnification arrangements under certain of its facility leases that require it to indemnify the landlord against certain costs, expenses, fines, suits, claims, demands, liabilities, and actions directly resulting from certain breaches, violations, or non‑performance of any covenant or condition of the Company’s lease. The term of the indemnification is for the term of the related lease agreement. The maximum potential amount of future payments the Company could be required to make under these indemnification agreements is unlimited. To date, the Company had not experienced any material losses related to any of its indemnification obligations, and no material claims with respect thereto were outstanding. |
Summary of Significant Accoun_2
Summary of Significant Accounting Policies (Policies) | 3 Months Ended |
Mar. 31, 2019 | |
Accounting Policies [Abstract] | |
Principles of Consolidation | Principles of Consolidation The consolidated financial statements include the accounts of the Company and its wholly owned subsidiaries, Selecta RUS, LLC (“Selecta (RUS)”), a Russian limited liability corporation, and Selecta Biosciences Security Corporation, a Massachusetts Security Corporation. All significant intercompany accounts and transactions have been eliminated. |
Foreign Currency | Foreign CurrencyThe functional currency of Selecta (RUS) is the Russian ruble. Assets and liabilities of Selecta (RUS) are translated at period-end exchange rates, while revenues and expenses are translated at average exchange rates for the period. Translation gains and losses are reflected in accumulated other comprehensive loss within stockholders’ deficit. Foreign currency transaction gains or losses are reflected in the consolidated statements of operations and comprehensive loss. |
Use of Estimates | Use of Estimates The preparation of consolidated financial statements in conformity with U.S. GAAP requires the Company’s management to make estimates and assumptions that affect the reported amounts of assets and liabilities, the disclosure of contingent assets and liabilities at the date of the consolidated financial statements and the reported amounts of revenues and expenses during the reporting period. The Company’s management considers many factors in selecting appropriate financial accounting policies and controls, and bases its estimates on historical experience and other market-specific or other relevant assumptions that it believes to be reasonable under the circumstances. In preparing these consolidated financial statements, management used significant estimates in the following areas, among others: revenue recognition, accounting for stock-based compensation and estimating accrued research and development expenses. The Company assesses the above estimates on an ongoing basis; however, actual results could materially differ from those estimates. |
Segment Information | Segment Information Operating segments are identified as components of an enterprise about which separate discrete financial information is available for evaluation by the chief operating decision maker, the Company’s Chief Executive Officer, in making decisions regarding resource allocation and assessing performance. The Company views its operations and manages its business in one |
Cash Equivalents, Short-term Investments and Restricted Cash | Cash Equivalents, Short-term Investments and Restricted Cash Cash equivalents include all highly liquid investments maturing within 90 days from the date of purchase. Investments consist of securities with remaining maturities greater than 90 days when purchased. The Company classifies these investments as available-for-sale and records them at fair value in the accompanying consolidated balance sheets. Investments with less than one year until maturity are classified as short term, while investments with maturities greater than one year are classified as long term. Unrealized gains or losses are included in accumulated other comprehensive income (loss). Premiums or discounts from par value are amortized to investment income over the life of the underlying investment. Although available to be sold to meet operating needs or otherwise, securities are generally held through maturity. The cost of securities sold is determined based on the specific identification method for purposes of recording realized gains and losses. During the reporting periods, there were no |
Concentrations of Credit Risk and Off-Balance Sheet Risk | Concentrations of Credit Risk and Off‑Balance Sheet RiskFinancial instruments that potentially subject the Company to concentration of credit risk consist primarily of cash, cash equivalents, short-term deposits and investments, and accounts receivable. Cash and cash equivalents are deposited with federally insured financial institutions in the United States and may, at times, exceed federally insured limits. Management believes that the financial institutions that hold the Company’s deposits are financially credit worthy and, accordingly, minimal risk exists with respect to those balances. Generally, these deposits may be redeemed upon demand and therefore bear minimal interest rate risk. As an integral part of operating its Russian subsidiary, the Company also maintains cash in Russian bank accounts in denominations of both Russian rubles and U.S. dollars. |
Fair Value of Financial Instruments | Fair Value of Financial Instruments The Company’s financial instruments consist mainly of cash equivalents, short‑term investments, restricted cash, accounts payable, loans payable, and common stock warrants. The carrying amounts of cash equivalents, short-term investments, restricted cash, accounts receivable, and accounts payable approximate their estimated fair value due to their short-term maturities. At March 31, 2019 , the carrying amount of the Company's loan payable approximates its estimated fair value due to the short-term nature of the instrument. Accounting standards define fair value as 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. A three‑level hierarchy is used to prioritize the inputs to valuation techniques used to measure fair value. The hierarchy gives the highest priority to unadjusted quoted prices in active markets for identical assets or liabilities (Level 1 measurements), and the lowest priority to unobservable inputs (Level 3 measurements). The three levels of the fair value hierarchy are described below: Level 1 —Level 1 inputs are quoted prices in active markets for identical assets or liabilities that the reporting entity has the ability to access at the measurement date. Level 2 —Level 2 inputs are inputs other than quoted prices included within Level 1 that are observable for the asset or liability, either directly or indirectly. If the asset or liability has a specified (contractual) term, a Level 2 input must be observable for substantially the full term of the asset or liability. Level 3 —Level 3 inputs are unobservable inputs for the asset or liability in which there is little, if any, market activity for the asset or liability at the measurement date. To the extent that a valuation is based on models or inputs that are less observable or unobservable in the market, the determination of fair value requires more judgment. Accordingly, the degree of judgment exercised by the Company in determining fair value is greatest for instruments categorized in Level 3. A financial instrument’s level within the fair value hierarchy is based on the lowest level of any input that is significant to the fair value measurement. The fair value of the Company's loan payable was determined using Level 2 inputs. |
Property and Equipment | Property and Equipment Property and equipment are recorded at cost and depreciated using the straight‑line method over the estimated useful lives of the respective assets, generally seven years for furniture and fixtures, five years for laboratory equipment, software and office equipment and three years |
Impairment of Long-Lived Assets | Impairment of Long‑Lived AssetsThe Company reviews long‑lived assets for impairment whenever events or changes in circumstances indicate that the carrying value of an asset may not be recoverable. In order to determine if assets have been impaired, assets are tested at the lowest level for which identifiable independent cash flows are available, which is at the entity level ("asset group"). An impairment loss is recognized when the sum of projected undiscounted cash flows is less than the carrying value of the asset group. The measurement of the impairment loss to be recognized is based on the difference between the fair value and the carrying value of the asset group. |
Debt Issuance Costs | Debt Issuance CostsDebt issuance costs and fees paid to lenders are classified as a debt discount and are recorded as a direct deduction from the face amount of the related debt. Issuance costs paid to third parties that are the direct result of the debt issuance are capitalized as a direct deduction from the face amount of the related debt. Debt issuance costs are amortized over the term of the related debt using the interest method and recorded as interest expense. Costs and fees paid to third parties are expensed as incurred. |
Accumulated Other Comprehensive Income (Loss) | Accumulated Other Comprehensive Income (Loss) Comprehensive income (loss) is defined as the change in the equity of a business entity during a period from transactions and other events and circumstances from non‑owner sources. It includes all changes in equity during a period except those resulting from investments by owners and distributions to owners. Comprehensive income (loss) consists of: (i) all components of net |
Revenue Recognition | Revenue Recognition Revenue is recognized when a 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. To determine revenue recognition for arrangements that an entity determines are within the scope of ASC 606, the Company performs the following five steps: (i) identify the contract(s) with a customer; (ii) identify the performance obligations in the contract, including whether they are distinct in the context of the contract; (iii) determine the transaction price, including the constraint on variable consideration; (iv) allocate the transaction price to the performance obligations in the contract; and (v) recognize revenue when (or as) the Company satisfies each performance obligation. The Company only applies the five-step model to contracts when it is probable that the entity will collect the consideration it is entitled to in exchange for the goods or services it transfers to the customer. At contract inception, once the contract is determined to be within the scope of ASC 606, the Company assesses the goods or services promised within each contract and determines those that are performance obligations, and assesses whether each promised good or service is distinct. If a promised good or service is not distinct, it is combined with other performance obligations. The Company then recognizes as revenue the amount of the transaction price that is allocated to the respective performance obligation when (or as) the performance obligation is satisfied. For example, certain performance obligations associated with Spark (see Note 13 to the Company's consolidated financial statements included elsewhere in this Quarterly Report on Form 10-Q ) will be satisfied over time, and revenue will be recognized using the output method, based on the proportion of actual deliveries to the total expected deliveries over the initial term. Collaboration and Grant Revenue The Company currently generates its revenue through grants, collaboration and license agreements with strategic collaborators for the development and commercialization of product candidates. The grants, collaboration and license agreements are within the scope of ASC 606. In determining the appropriate amount of revenue to be recognized as it fulfills its obligations under the agreements, the Company performs the five steps above. As part of the accounting for the arrangement, the Company must develop assumptions that require judgment to determine the stand-alone selling price for each performance obligation identified in the contract. The Company uses key assumptions to determine the stand-alone selling price, which may include market conditions, reimbursement rates for personnel costs, development timelines and probabilities of regulatory success. Licenses of intellectual property: If the license to the Company’s intellectual property is determined to be distinct from the other performance obligations identified in the arrangement, the Company recognizes revenues from non-refundable, up-front fees allocated to the license when the license is transferred to the customer and the customer is able to use and benefit from the license. If not distinct, the license is combined with other performance obligations in the contract. For licenses that are combined with other performance obligations, the Company assesses the nature of the combined performance obligation to determine whether the combined performance obligation is satisfied over time or at a point in time and, if over time, the appropriate method of measuring progress for purposes of recognizing revenue. The Company evaluates the measure of progress each reporting period and, if necessary, adjusts the measure of performance and related revenue recognition. Optional licenses are evaluated to determine if they are issued at a discount, and therefore, represent material rights and accounted for as separate performance obligations. Milestone Payments: At the inception of each arrangement that includes developmental and regulatory milestone payments, the Company evaluates whether the achievement of each milestone specifically relates to the Company’s efforts to satisfy a performance obligation or transfer a distinct good or service within a performance obligation. If the achievement of a milestone is considered a direct result of the Company’s efforts to satisfy a performance obligation or transfer a distinct good or service and the receipt of the payment is based upon the achievement of the milestone, the associated milestone value is allocated to that distinct good or service. If the milestone payment is not specifically related to the Company’s effort to satisfy a performance obligation or transfer a distinct good or service, the amount is allocated to all performance obligations using the relative standalone selling price method. The Company also evaluates the milestone to determine whether they are considered probable of being reached and estimates the amount to be included in the transaction price using the most likely amount method. If it is probable that a significant revenue reversal would not occur, the associated milestone value is included in the transaction price to be allocated, otherwise, such amounts are constrained and excluded from the transaction price. At the end of each subsequent reporting period, the Company re-evaluates the probability of achievement of such development milestones and any related constraint, and if necessary, adjusts its estimate of the transaction price. Any such adjustments to the transaction price are allocated to the performance obligations on the same basis as at contract inception. Amounts allocated to a satisfied performance obligation shall be recognized as revenue, or as a reduction of revenue, in the period in which the transaction price changes. Manufacturing Supply Services: Arrangements that include a promise for future supply of drug substance or drug product for either clinical development or commercial supply at the customer’s discretion are evaluated to determine if they are distinct and optional. For optional services that are distinct, the Company assesses if they are priced at a discount, and therefore, provide a material right to the licensee to be accounted for as separate performance obligations. Royalties: |
Research and Development Costs | Research and Development CostsCosts incurred in the research and development of the Company’s products are expensed as incurred. Research and development expenses include costs incurred in performing research and development activities, including salaries and benefits, facilities cost, overhead costs, contract services, supplies and other outside costs. Nonrefundable advance payments for goods and services that will be used in future research and development activities are expensed when the activity has been performed or when the goods have been received rather than when the payment is made. |
Clinical Trial Costs | Clinical Trial CostsClinical trial expenses are a significant component of research and development expenses, and we outsource a significant portion of these costs to third parties. Third party clinical trial expenses include patient costs, clinical research organization costs and costs for data management. The accrual for site and patient costs includes inputs such as estimates of patient enrollment, patient cycles incurred, clinical site activations, and other pass-through costs. Payments for these activities are based on the terms of the individual arrangements, which may differ from the pattern of costs incurred, and are reflected on the consolidated balance sheets as a prepaid asset or accrued clinical trial cost. These third party agreements are generally cancelable, and related costs are recorded as research and development expenses as incurred. Non-refundable advance clinical payments for goods or services that will be used or rendered for future R&D activities are recorded as a prepaid asset and recognized as expense as the related goods are delivered or the related services are performed. We also record accruals for estimated ongoing clinical research and development costs. When evaluating the adequacy of the accrued liabilities, we analyze progress of the studies, including the phase or completion of events, invoices received and contracted costs. Significant judgments and estimates may be made in determining the accrued balances at the end of any reporting period. Actual results could differ from the estimates made by the Company. The historical clinical accrual estimates made by the Company have not been materially different from the actual costs. |
Income Taxes | Income Taxes The Company provides deferred tax assets and liabilities for the expected future tax consequences of temporary differences between the Company’s financial statement carrying amounts and the tax basis of assets and liabilities using enacted tax rates expected to be in effect in the years in which the differences are expected to reverse. A valuation allowance is provided to reduce the deferred tax assets to the amount that will more-likely-than-not be realized. |
Warrants | Warrants The Company determines the accounting classification of warrants that are issued, as either liability or equity, by first assessing whether the warrants meet liability classification in accordance with ASC 480-10, Accounting for Certain Financial Instruments with Characteristics of both Liabilities and Equity , and then in accordance with ASC 815-40, Accounting for Derivative Financial Instruments Indexed to, and Potentially Settled in, a Company’s Own Stock . Under ASC 480, warrants are considered liability classified if the warrants are mandatorily redeemable, obligate the issuer to settle the warrants or the underlying shares by paying cash or other assets, or warrants that must or may require settlement by issuing variable number of shares. |
Stock-Based Compensation | Stock‑Based CompensationThe Company accounts for all stock‑based compensation granted to employees and non‑employees using a fair value method. Stock‑based compensation is measured at the grant date fair value and is recognized over the requisite service period of the awards, usually the vesting period, on a straight‑line basis, net of estimated forfeitures. The Company reduces recorded stock‑based compensation for estimated forfeitures. To the extent that actual forfeitures differ from the Company’s estimates, the differences are recorded as a cumulative adjustment in the period the estimates were adjusted. Stock‑based compensation expense recognized in the consolidated financial statements is based on awards that are ultimately expected to vest. |
Net Loss Per Share | Net Loss Per ShareThe Company has reported losses since inception and has computed basic net loss per share by dividing net loss by the weighted average number of common shares outstanding for the period. The Company has computed diluted net loss per common share after considering all potentially dilutive common shares, including stock options, convertible preferred stock, and warrants outstanding during the period except where the effect of including such securities would be antidilutive. Because the Company has reported net losses since inception, these potential common shares have been anti‑dilutive and basic and diluted loss per share have been the same. |
Contingent Liabilities | Contingent Liabilities The Company accounts for its contingent liabilities in accordance with ASC No. 450, Contingencies |
Leases | Leases Under ASC 842 which was adopted January 1, 2019, the Company determines whether the arrangement is or contains a lease based on the unique facts and circumstances present. Most leases with a term greater than one year are recognized on the balance sheet as right-of-use assets, lease liabilities and, if applicable, long-term lease liabilities. The Company elected not to recognize leases with a term less than one year on our balance sheet. Operating lease right-of-use (ROU) assets and their corresponding lease liabilities are recorded based on the present value of lease payments over the expected remaining lease term. The interest rate implicit in lease contracts is typically not readily determinable. As a result, the Company utilizes its incremental borrowing rates, which are the rates incurred to borrow on a collateralized basis over a similar term, an amount equal to the lease payments in a similar economic environment. |
Recent Accounting Pronouncements | Recent Accounting Pronouncements In June 2016, the FASB issued Accounting Standards Update No. ("ASU") 2016-13, Financial Instruments-Credit Losses (Topic 326), Measurement of Credit Losses on Financial Instruments. Subsequently, in November 2018, the FASB issued ASU 2018-19, “Codification Improvements to Topic 326, Financial Instruments-Credit Losses”. ASU 2016-13 requires entities to measure all expected credit losses for most financial assets held at the reporting date based on an expected loss model which includes historical experience, current conditions, and reasonable and supportable forecasts. ASU 2016-13 also requires enhanced disclosures to help financial statement users better understand significant estimates and judgments used in estimating credit losses. This ASU is effective for public entities for fiscal years beginning after December 15, 2019, with early adoption permitted. The Company is assessing the impact this standard will have on its consolidated financial statements and disclosures. In February 2016, the FASB issued Accounting Standards Update No. (“ASU”) 2016-02, “Leases (Topic 842).” ASU 2016-02 requires lessees to recognize most leases on their balance sheet as a right-of-use asset and a lease liability. Leases are classified as either operating or finance based on criteria similar to current lease accounting, with the classification affecting the pattern and classification of expense recognition in the statement of operations. Subsequently, in July 2018, the FASB issued ASU No. 2018-11, Leases (Topic 842): Targeted Improvements (“ASU 2018-11”), which includes certain amendments to ASU 2016-02 intended to provide relief in implementing the new standard. Among these amendments is the option to not restate comparative periods presented in the financial statements. The Company has elected this transition approach, using a cumulative-effect adjustment on the effective date of the standard, with comparative periods presented in accordance with the existing guidance in ASC 840. Pursuant to the guidance under ASU 2016-02, the Company elected certain available expedients by electing the transition package of practical expedients permitted with ASU 2016-02, which allows the Company the option not to reassess previous accounting conclusions around, (i) whether expired or existing contracts contain leases, (ii) lease classification for any expired or existing leases, and (iii) the treatment of initial direct costs for any existing leases. The Company also made an accounting policy election to exclude leases with an initial term of 12 months or less from their balance sheet. The Company adopted the new standard as of the required effective date of January 1, 2019 resulting in the recognition of a net additional lease liability and right-of-use asset. The standard did not impact the Company's consolidated net loss or cash flows. See Note 9 for details. In August 2018, the FASB issued ASU No. 2018-13, " Fair Value Measurement (Topic 820): Changes to the Disclosure Requirements for Fair Value Measurement" (ASU 2018-13) which changes the fair value measurement disclosure requirements of ASC 820. This ASU is effective for public entities for fiscal years beginning after December 15, 2019, with early adoption permitted. The Company is assessing the impact this standard will have on its consolidated financial statements and disclosures. In November 2018, the FASB issued ASU No. 2018-18, “Collaborative Arrangements (Topic 808): Clarifying the Interaction between Topic 808 and Topic 606” |
Summary of Significant Accoun_3
Summary of Significant Accounting Policies (Tables) | 3 Months Ended |
Mar. 31, 2019 | |
Accounting Policies [Abstract] | |
Schedule of Cash and Cash Equivalents | The following table provides a reconciliation of cash, cash equivalents, and restricted cash reported within the consolidated balance sheet that sum to the total of the same such amounts shown in the consolidated statement of cash flows: Three Months Ended March 31, 2019 2018 Cash and cash equivalents $ 32,173 $ 58,228 Restricted cash 279 76 Restricted cash included in other assets — 329 Total cash, cash equivalents, and restricted cash shown in the consolidated statement of cash flows $ 32,452 $ 58,633 |
Schedule of Restricted Cash and Cash Equivalents | The following table provides a reconciliation of cash, cash equivalents, and restricted cash reported within the consolidated balance sheet that sum to the total of the same such amounts shown in the consolidated statement of cash flows: Three Months Ended March 31, 2019 2018 Cash and cash equivalents $ 32,173 $ 58,228 Restricted cash 279 76 Restricted cash included in other assets — 329 Total cash, cash equivalents, and restricted cash shown in the consolidated statement of cash flows $ 32,452 $ 58,633 |
Components of Accumulated Other Comprehensive Income (Loss), Net of Tax | The components of accumulated other comprehensive income (loss), net of tax, were as follows (in thousands): Foreign currency translation adjustment Unrealized gains (losses) on available-for-sale securities Accumulated other comprehensive income (loss) Balance at December 31, 2018 $ (4,557 ) $ — $ (4,557 ) Other comprehensive income (loss) during the period $ 22 $ 2 $ 24 Balance at March 31, 2019 $ (4,535 ) $ 2 $ (4,533 ) |
Available-for-Sale Marketable_2
Available-for-Sale Marketable Securities (Tables) | 3 Months Ended |
Mar. 31, 2019 | |
Investments, Debt and Equity Securities [Abstract] | |
Summary of Available-for-Sale Marketable Securities | The following tables summarize the Company’s available-for-sale marketable securities by major type of security as of March 31, 2019 (in thousands): March 31, 2019 Amortized Cost Gross Unrealized Gains Gross Unrealized Losses Fair Value U.S. government and agency securities $ 9,935 $ 1 $ — $ 9,936 Corporate bonds and commercial paper 6,308 — — 6,308 Total available-for-sale marketable securities $ 16,243 $ 1 $ — $ 16,244 |
Schedule of Fair Values and Amortized Cost of Marketable Debt Securities by Contractual Maturity | The fair values and amortized cost of marketable debt securities by contractual maturity were as follows (in thousands): March 31, 2019 December 31, 2018 Fair Value Amortized Cost Fair Value Amortized Cost Less than one year $ 16,244 $ 16,243 $ — $ — |
Net Loss Per Share (Tables)
Net Loss Per Share (Tables) | 3 Months Ended |
Mar. 31, 2019 | |
Earnings Per Share [Abstract] | |
Computation of Basic and Diluted Net Loss Per Share | The following table sets forth the computation of basic and diluted net loss per share (in thousands, except share and per‑share data): Three Months Ended March 31, 2019 2018 Numerator: Net loss attributable to common stockholders $ (12,074 ) $ (15,888 ) Denominator: Weighted‑average common shares outstanding—basic and diluted 38,447,319 22,345,523 Net loss per share attributable to common stockholders —basic and diluted $ (0.31 ) $ (0.71 ) |
Schedule of Potential Common Shares Issuable Upon Conversion of Warrants | Potential dilutive common share equivalents consist of the following: March 31, 2019 2018 Stock options to purchase common stock 4,564,742 2,658,035 Unvested restricted stock units 275,000 — Stock warrants to purchase common stock 95,619 176,432 Total 4,935,361 2,834,467 |
Fair Value Measurements (Tables
Fair Value Measurements (Tables) | 3 Months Ended |
Mar. 31, 2019 | |
Fair Value Disclosures [Abstract] | |
Summary of Assets Measured at Fair Value on a Recurring Basis | Below is a summary of assets measured at fair value on a recurring basis (in thousands): March 31, 2019 (Level 1) (Level 2) (Level 3) Total Cash equivalents: Money market funds $ 489 $ — $ — $ 489 Total cash equivalents $ 489 $ — $ — $ 489 Short-term investments: U.S. government and agency securities $ — $ 9,936 $ — $ 9,936 Corporate bonds and commercial paper — 6,308 — 6,308 Total short-term investments $ — $ 16,244 $ — $ 16,244 December 31, 2018 (Level 1) (Level 2) (Level 3) Total Cash equivalents: Money market funds $ 10,123 $ — $ — $ 10,123 Total cash equivalents $ 10,123 $ — $ — $ 10,123 |
Property and Equipment (Tables)
Property and Equipment (Tables) | 3 Months Ended |
Mar. 31, 2019 | |
Property, Plant and Equipment [Abstract] | |
Schedule of Property and Equipment | Property and equipment consists of the following (in thousands): March 31, December 31, 2019 2018 Laboratory equipment $ 4,932 $ 5,379 Computer equipment and software 481 561 Leasehold improvements 278 278 Furniture and fixtures 235 247 Office equipment 135 135 Construction in process — 79 Total property and equipment 6,061 6,679 Less accumulated depreciation (4,262 ) (4,552 ) Property and equipment, net $ 1,799 $ 2,127 |
Accrued Expenses (Tables)
Accrued Expenses (Tables) | 3 Months Ended |
Mar. 31, 2019 | |
Payables and Accruals [Abstract] | |
Schedule of Accrued Expenses | Accrued expenses consist of the following (in thousands): March 31, December 31, 2019 2018 Payroll and employee related expenses $ 1,875 $ 2,497 Current portion of deferred rent and lease incentive — 117 Collaboration and licensing 831 1,222 Accrued patent fees 510 736 Accrued external research and development costs 3,826 5,344 Accrued professional and consulting services 920 994 Accrued grant refund 175 175 Accrued interest 109 106 Other 254 509 Accrued expenses $ 8,500 $ 11,700 |
Prepaid Expenses and Other Cu_2
Prepaid Expenses and Other Current Assets (Tables) | 3 Months Ended |
Mar. 31, 2019 | |
Deferred Costs, Capitalized, Prepaid, and Other Assets Disclosure [Abstract] | |
Components of Prepaid Expenses and Other Current Assets | Prepaid expenses and other current assets consist of the following (in thousands): March 31, December 31, 2019 2018 Clinical operations $ 9,916 $ 3,550 Insurance 222 433 Rent 192 188 Service agreements 426 422 Other 76 80 $ 10,832 $ 4,673 |
Leases (Tables)
Leases (Tables) | 3 Months Ended |
Mar. 31, 2019 | |
Leases [Abstract] | |
Schedule of Lease, Cost | The following summarizes additional information related to operating leases: March 31, Operating leases: 2019 Weighted-average remaining lease term (years) 1.0 year Weighted-average discount rate 10 % March 31, Operating leases: 2019 Supplemental Cash Flows Information Operating cash flows from operating leases $ 363 March 31, 2019 Operating lease expense $ 341 Variable lease expense 203 Short-term lease expense 8 Total lease expense $ 552 |
Schedule of Lessee, Operating Lease, Liability, Maturity | The maturity of the Company's operating lease liabilities as of March 31, 2019 were as follows (in thousands): March 31, Operating leases: 2019 2019 (Remainder) 1,119 2020 375 Total future minimum lease payments 1,494 Less imputed interest 66 Total operating lease liabilities 1,428 Included in the condensed consolidated balance sheet: Current operating lease liabilities 1,428 Non-current operating lease liabilities — Total operating lease liabilities 1,428 |
Schedule of Future Minimum Lease Payments | As previously disclosed in our 2018 Annual Report on Form 10-K and under the previous lease accounting standard, ASC 840, Leases, the total commitment for non-cancelable operating leases was $ 1.9 million as of December 31, 2018 (in thousands): Lease Commitments 2019 (Remainder) $ 1,482 2020 375 Total $ 1,857 |
Debt (Tables)
Debt (Tables) | 3 Months Ended |
Mar. 31, 2019 | |
Debt Disclosure [Abstract] | |
Schedule of Future Minimum Payments on the Term Loans | Future minimum principal and interest payments on the 2017 Term Loan as of March 31, 2019 are as follows (in thousands): 2019 (Remainder) 4,427 2020 9,232 2021 8,718 2022 1,754 Total minimum debt payments $ 24,131 Less: Amount representing interest (2,081 ) Less: Debt discount and deferred charges (584 ) Less: Current portion of loan payable (21,466 ) Loan payable, net of current portion $ — |
Stockholders' Equity (Tables)
Stockholders' Equity (Tables) | 3 Months Ended |
Mar. 31, 2019 | |
Equity [Abstract] | |
Schedule of Authorized Shares of Common Stock for Future Issuance | The Company has authorized shares of common stock for future issuance as follows: Period ending March 31, 2019 December 31, 2018 Exercise of common warrants 95,619 95,619 Shares available for future stock incentive awards 4,012,207 1,586,925 RSUs reserved for issuance 50,000 — Unvested restricted stock units 225,000 175,000 Outstanding common stock options 4,564,742 4,093,979 Total 8,947,568 5,951,523 |
Stock Incentive Plans (Tables)
Stock Incentive Plans (Tables) | 3 Months Ended |
Mar. 31, 2019 | |
Disclosure of Compensation Related Costs, Share-based Payments [Abstract] | |
Schedule of Weighted Average Assumptions Used | The estimated grant date fair values of employee stock option awards granted under the 2008 Plan, 2016 Plan and the Inducement Incentive Award Plan were calculated using the Black-Scholes option pricing model, based on the following weighted-average assumptions: Three Months Ended March 31, 2019 2018 Risk-free interest rate 2.45 % 2.65 % Dividend yield — — Expected term 6.06 6.64 Expected volatility 87.35 % 84.81 % Weighted-average fair value of common stock $ 2.41 $ 9.53 |
Summary of Activity Under the 2008 Plan and the 2016 Plan | The following table summarizes the activity under the 2008 Plan, 2016 Plan, and Inducement Incentive Award Plan: Weighted‑average remaining Aggregate Number of Weighted-average contractual term intrinsic value options exercise price ($) (in years) (in thousands) Employee Awards Outstanding at December 31, 2018 3,681,575 $ 9.49 7.77 $ 300 Granted 1,319,500 $ 2.41 Exercised (115,600 ) $ 1.26 Forfeited (733,137 ) $ 10.51 Outstanding at March 31, 2019 4,152,338 $ 7.29 8.53 $ 195 Vested at March 31, 2019 1,071,591 $ 10.06 5.98 $ 107 Vested and expected to vest at March 31, 2019 3,893,328 $ 7.39 8.47 $ 189 Non‑Employee Awards Outstanding at December 31, 2018 412,404 $ 6.44 6.42 $ 28 Granted — $ — Exercised — $ — Forfeited — $ — Outstanding at March 31, 2019 412,404 $ 6.44 6.18 $ 24 Vested at March 31, 2019 227,986 $ 4.21 3.73 $ 24 Vested and expected to vest at March 31, 2019 412,404 $ 6.44 6.18 $ 24 |
Disclosure of Share-based Compensation Arrangements by Share-based Payment Award | The following table summarizes the status of the Company’s restricted stock units: Number of Shares (#) Weighted Average Fair Value ($) Unvested at December 31, 2018 175,000 $ 6.03 Granted 50,000 2.29 Vested — — Reserved for issuance 50,000 — Forfeited — — Unvested at March 31, 2019 275,000 $ 5.20 |
Schedule of Stock-Based Compensation Expense Related to Stock Options and Restricted Common Stock | The Company recorded stock-based compensation expense related to stock option awards, restricted stock units and the ESPP in the following expense categories of its consolidated statements of operations and comprehensive loss (in thousands): Three Months Ended March 31, 2019 2018 Research and development $ 519 $ 511 General and administrative 661 642 Total stock-based compensation expense $ 1,180 $ 1,153 |
Revenue Arrangements (Tables)
Revenue Arrangements (Tables) | 3 Months Ended |
Mar. 31, 2019 | |
Revenue from Contract with Customer [Abstract] | |
Schedule of Changes in Contract Liabilities | The following table presents changes in the Company’s contract liabilities during the three months ended March 31, 2019 (in thousands): Balance at Balance at Beginning of Period Additions Deductions End of Period Three Months Ended March 31, 2019 Contract liabilities: Deferred revenue $ 14,777 $ 8 $ (10 ) $ 14,775 Other liabilities (i) 2,126 — (493 ) 1,633 Total contract liabilities $ 16,903 $ 8 $ (503 ) $ 16,408 (i) As of March 31, 2019 , the current portion of other liabilities in the amount of $0.8 million is presented in the accrued expenses line of the consolidated balance sheet. The non-current portion of other liabilities in the amount of $0.8 million |
Related-Party Transactions - (T
Related-Party Transactions - (Tables) | 3 Months Ended |
Mar. 31, 2019 | |
Related Party Transactions [Abstract] | |
Schedule of Related Party Transactions | The following table sets forth the number of shares of common stock purchased in our registered public offering by directors (and related parties thereto) and holders of more than 5% of our common stock: Name Shares of Common Total Timothy A. Springer, Ph.D. 4,000,000 $ 6,000,000.00 Entities affiliated with NanoDimension 1,666,666 $ 2,499,999.00 Entities affiliated with OrbiMed Advisors 1,333,333 $ 1,999,999.50 Entities affiliated with Polaris 666,666 $ 999,999.00 SAF-BND Trust (affiliate of Omid Farokhzad, M.D.) 83,333 $ 124,999.50 Chafen Lu (Timothy Springer’s wife) 66,666 $ 99,999.00 Jed Springer (Timothy Springer’s brother) 1,000 $ 1,500.00 |
Nature of the Business and Ba_2
Nature of the Business and Basis of Presentation - Liquidity (Details) - USD ($) $ in Thousands | Mar. 31, 2019 | Dec. 31, 2018 | Mar. 31, 2018 | Dec. 31, 2017 |
Organization, Consolidation and Presentation of Financial Statements [Abstract] | ||||
Accumulated deficit | $ 292,477 | $ 280,403 | ||
Cash and Cash Equivalents [Line Items] | ||||
Short-term deposits and investments | 16,244 | 0 | ||
Cash, cash equivalents, and restricted cash | 32,452 | $ 37,682 | $ 58,633 | $ 71,027 |
Russian subsidiary | Unrestricted cash | ||||
Cash and Cash Equivalents [Line Items] | ||||
Cash, cash equivalents, and restricted cash | $ 400 |
Summary of Significant Accoun_4
Summary of Significant Accounting Policies - Segment Information (Details) | 3 Months Ended |
Mar. 31, 2019segment | |
Accounting Policies [Abstract] | |
Number of operating segments | 1 |
Summary of Significant Accoun_5
Summary of Significant Accounting Policies - Cash Equivalents, Short Term Investments and Restricted Cash (Details) | 3 Months Ended |
Mar. 31, 2019USD ($) | |
Accounting Policies [Abstract] | |
Realized gains or losses on sale of investments | $ 0 |
Summary of Significant Accoun_6
Summary of Significant Accounting Policies - Schedule of Reconciliation of Cash, Cash Equivalents and Restricted Cash (Details) - USD ($) $ in Thousands | Mar. 31, 2019 | Dec. 31, 2018 | Mar. 31, 2018 | Dec. 31, 2017 |
Accounting Policies [Abstract] | ||||
Cash and cash equivalents | $ 32,173 | $ 58,228 | ||
Restricted cash | 279 | 76 | ||
Restricted cash included in other assets | 0 | 329 | ||
Total cash, cash equivalents, and restricted cash shown in the consolidated statement of cash flows | $ 32,452 | $ 37,682 | $ 58,633 | $ 71,027 |
Summary of Significant Accoun_7
Summary of Significant Accounting Policies - Concentrations of Credit Risk and Off-Balance Sheet Risk (Details) - Russian subsidiary $ in Millions | Mar. 31, 2019USD ($) |
Concentration Risk [Line Items] | |
Cash maintained in Russian bank accounts | $ 0.4 |
U.S. dollars | |
Concentration Risk [Line Items] | |
Cash maintained in Russian bank accounts | $ 0.4 |
Summary of Significant Accoun_8
Summary of Significant Accounting Policies - Property and Equipment (Details) | 3 Months Ended |
Mar. 31, 2019 | |
Furniture and fixtures | |
Property, Plant and Equipment [Line Items] | |
Estimated useful life | 7 years |
Laboratory equipment, software and office equipment | |
Property, Plant and Equipment [Line Items] | |
Estimated useful life | 5 years |
Computer equipment | |
Property, Plant and Equipment [Line Items] | |
Estimated useful life | 3 years |
Summary of Significant Accoun_9
Summary of Significant Accounting Policies - Impairment of Long‑Lived Assets (Details) - USD ($) | 3 Months Ended | |
Mar. 31, 2019 | Mar. 31, 2018 | |
Accounting Policies [Abstract] | ||
Impairment of intangible assets, finite-lived | $ 0 | $ 0 |
Summary of Significant Accou_10
Summary of Significant Accounting Policies - Components of Accumulated Other Comprehensive Income (Loss), Net of Tax (Details) $ in Thousands | 3 Months Ended |
Mar. 31, 2019USD ($) | |
AOCI Attributable to Parent, Net of Tax | |
Beginning balance | $ (5,418) |
Ending balance | 14,819 |
Foreign currency translation adjustment | |
AOCI Attributable to Parent, Net of Tax | |
Beginning balance | (4,557) |
Other comprehensive income (loss) during the period | 22 |
Ending balance | (4,535) |
Unrealized gains (losses) on available-for-sale securities | |
AOCI Attributable to Parent, Net of Tax | |
Beginning balance | 0 |
Other comprehensive income (loss) during the period | 2 |
Ending balance | 2 |
Accumulated other comprehensive income (loss) | |
AOCI Attributable to Parent, Net of Tax | |
Beginning balance | (4,557) |
Other comprehensive income (loss) during the period | 24 |
Ending balance | $ (4,533) |
Available-for-Sale Marketable_3
Available-for-Sale Marketable Securities - Summary of Available-for-Sale Marketable Securities (Details) $ in Thousands | Mar. 31, 2019USD ($)position |
Investments, Debt and Equity Securities [Abstract] | |
Debt securities, available-for-sale, number of positions | position | 15 |
Debt securities, available-for-sale, continuous unrealized loss position, 12 months or longer, number of positions | position | 0 |
Debt Securities, Available-for-sale [Line Items] | |
Amortized Cost | $ 16,243 |
Gross Unrealized Gains | 1 |
Gross Unrealized Losses | 0 |
Fair Value | 16,244 |
U.S. government and agency securities | |
Debt Securities, Available-for-sale [Line Items] | |
Amortized Cost | 9,935 |
Gross Unrealized Gains | 1 |
Gross Unrealized Losses | 0 |
Fair Value | 9,936 |
Corporate bonds | |
Debt Securities, Available-for-sale [Line Items] | |
Amortized Cost | 6,308 |
Gross Unrealized Gains | 0 |
Gross Unrealized Losses | 0 |
Fair Value | $ 6,308 |
Available-for-Sale Marketable_4
Available-for-Sale Marketable Securities - Schedule of Fair Values and Amortized Cost of Marketable Debt Securities by Contractual Maturity (Details) - USD ($) $ in Thousands | Mar. 31, 2019 | Dec. 31, 2018 |
Fair Value | ||
Less than one year | $ 16,244 | $ 0 |
Amortized Cost | ||
Less than one year | $ 16,243 | $ 0 |
Net Loss Per Share - Computatio
Net Loss Per Share - Computation of Basic and Diluted Net Loss Per Share (Details) - USD ($) $ / shares in Units, $ in Thousands | 3 Months Ended | |
Mar. 31, 2019 | Mar. 31, 2018 | |
Numerator: | ||
Net loss | $ (12,074) | $ (15,888) |
Denominator: | ||
Weighted‑average common shares outstanding—basic and diluted (in shares) | 38,447,319 | 22,345,523 |
Net loss per share attributable to common stockholders—basic and diluted (in dollars per share) | $ (0.31) | $ (0.71) |
Net Loss Per Share - Schedule o
Net Loss Per Share - Schedule of Potential Common Shares Issuable Upon Conversion of Warrants (Details) - shares | 3 Months Ended | |
Mar. 31, 2019 | Mar. 31, 2018 | |
Potential common shares | ||
Total (in shares) | 4,935,361 | 2,834,467 |
Stock options to purchase common stock | ||
Potential common shares | ||
Total (in shares) | 4,564,742 | 2,658,035 |
Unvested restricted stock units | ||
Potential common shares | ||
Total (in shares) | 275,000 | 0 |
Stock warrants to purchase common stock | ||
Potential common shares | ||
Total (in shares) | 95,619 | 176,432 |
Fair Value Measurements - Summa
Fair Value Measurements - Summary of Assets Measured at Fair Value on a Recurring Basis (Details) - USD ($) $ in Thousands | 3 Months Ended | |
Mar. 31, 2019 | Dec. 31, 2018 | |
U.S. government and agency securities | ||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Investments maturity period | 145 days | |
Corporate bonds | ||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Investments maturity period | 250 days | |
Commercial paper | ||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Investments maturity period | 139 days | |
Recurring | ||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Total cash equivalents | $ 489 | $ 10,123 |
Total short-term investments | 16,244 | |
Recurring | (Level 1) | ||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Total cash equivalents | 489 | 10,123 |
Total short-term investments | 0 | |
Recurring | (Level 2) | ||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Total cash equivalents | 0 | 0 |
Total short-term investments | 16,244 | |
Recurring | (Level 3) | ||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Total cash equivalents | 0 | 0 |
Total short-term investments | 0 | |
Recurring | U.S. government and agency securities | ||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Total short-term investments | 9,936 | |
Recurring | U.S. government and agency securities | (Level 1) | ||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Total short-term investments | 0 | |
Recurring | U.S. government and agency securities | (Level 2) | ||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Total short-term investments | 9,936 | |
Recurring | U.S. government and agency securities | (Level 3) | ||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Total short-term investments | 0 | |
Recurring | Corporate bonds and commercial paper | ||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Total short-term investments | 6,308 | |
Recurring | Corporate bonds and commercial paper | (Level 1) | ||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Total short-term investments | 0 | |
Recurring | Corporate bonds and commercial paper | (Level 2) | ||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Total short-term investments | 6,308 | |
Recurring | Corporate bonds and commercial paper | (Level 3) | ||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Total short-term investments | 0 | |
Recurring | Money market funds | ||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Total cash equivalents | 489 | 10,123 |
Recurring | Money market funds | (Level 1) | ||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Total cash equivalents | 489 | 10,123 |
Recurring | Money market funds | (Level 2) | ||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Total cash equivalents | 0 | 0 |
Recurring | Money market funds | (Level 3) | ||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Total cash equivalents | $ 0 | $ 0 |
Property and Equipment - Schedu
Property and Equipment - Schedule of Property and Equipment (Details) - USD ($) $ in Thousands | Mar. 31, 2019 | Dec. 31, 2018 |
Property, Plant and Equipment [Line Items] | ||
Total property and equipment | $ 6,061 | $ 6,679 |
Less accumulated depreciation | (4,262) | (4,552) |
Property and equipment, net | 1,799 | 2,127 |
Laboratory equipment | ||
Property, Plant and Equipment [Line Items] | ||
Total property and equipment | 4,932 | 5,379 |
Computer equipment and software | ||
Property, Plant and Equipment [Line Items] | ||
Total property and equipment | 481 | 561 |
Leasehold improvements | ||
Property, Plant and Equipment [Line Items] | ||
Total property and equipment | 278 | 278 |
Furniture and fixtures | ||
Property, Plant and Equipment [Line Items] | ||
Total property and equipment | 235 | 247 |
Office equipment | ||
Property, Plant and Equipment [Line Items] | ||
Total property and equipment | 135 | 135 |
Construction in process | ||
Property, Plant and Equipment [Line Items] | ||
Total property and equipment | $ 0 | $ 79 |
Property and Equipment - Narrat
Property and Equipment - Narrative (Details) - USD ($) $ in Thousands | 3 Months Ended | |
Mar. 31, 2019 | Mar. 31, 2018 | |
Property, Plant and Equipment [Abstract] | ||
Depreciation expense | $ 181 | $ 169 |
Accrued Expenses (Details)
Accrued Expenses (Details) - USD ($) $ in Thousands | Mar. 31, 2019 | Dec. 31, 2018 |
Payables and Accruals [Abstract] | ||
Payroll and employee related expenses | $ 1,875 | $ 2,497 |
Current portion of deferred rent and lease incentive | 0 | 117 |
Collaboration and licensing | 831 | 1,222 |
Accrued patent fees | 510 | 736 |
Accrued external research and development costs | 3,826 | 5,344 |
Accrued professional and consulting services | 920 | 994 |
Accrued grant refund | 175 | 175 |
Accrued interest | 109 | 106 |
Other | 254 | 509 |
Accrued expenses | $ 8,500 | $ 11,700 |
Prepaid Expenses and Other Cu_3
Prepaid Expenses and Other Current Assets (Details) - USD ($) $ in Thousands | Mar. 31, 2019 | Dec. 31, 2018 |
Deferred Costs, Capitalized, Prepaid, and Other Assets Disclosure [Abstract] | ||
Clinical operations | $ 9,916 | $ 3,550 |
Insurance | 222 | 433 |
Rent | 192 | 188 |
Service agreements | 426 | 422 |
Other | 76 | 80 |
Prepaid expenses and other current assets | $ 10,832 | $ 4,673 |
Prepaid Expenses and Other Cu_4
Prepaid Expenses and Other Current Assets - Narrative (Details) - USD ($) $ in Thousands | Mar. 31, 2019 | Dec. 31, 2018 |
Property, Plant and Equipment [Line Items] | ||
Clinical operations | $ 9,916 | $ 3,550 |
Construction in process | ||
Property, Plant and Equipment [Line Items] | ||
Clinical operations | $ 6,200 | $ 0 |
Leases (Details)
Leases (Details) $ in Thousands | Jan. 01, 2019USD ($) | Mar. 31, 2019USD ($) | Mar. 31, 2018USD ($) | Dec. 31, 2018USD ($) | Oct. 31, 2017ft² | Dec. 31, 2012USD ($) |
Operating Leased Assets [Line Items] | ||||||
Right of use asset, net (Note 9) | $ 1,155 | |||||
Lease liabilities | 1,428 | |||||
Operating lease, remaining lease term | 15 months | |||||
Discount rate | 10.00% | |||||
Tenant improvement allowance | 6,061 | $ 6,679 | ||||
Area of additional office space leased | ft² | 5,100 | |||||
Rent expense | 500 | $ 500 | ||||
75 North Beacon, Watertown, MA | ||||||
Operating Leased Assets [Line Items] | ||||||
Right of use asset, net (Note 9) | $ 200 | 0 | ||||
Letter of credit | ||||||
Operating Leased Assets [Line Items] | ||||||
Restricted cash | $ 300 | |||||
Minimum | ||||||
Operating Leased Assets [Line Items] | ||||||
Term of contract | 2 years | |||||
Renewal term | 1 year | |||||
Maximum | ||||||
Operating Leased Assets [Line Items] | ||||||
Term of contract | 5 years | |||||
Renewal term | 5 years | |||||
Maximum | Laboratory and office space | ||||||
Operating Leased Assets [Line Items] | ||||||
Tenant improvement allowance | $ 700 | |||||
Accounting Standards Update 2016-02 [Member] | ||||||
Operating Leased Assets [Line Items] | ||||||
Right of use asset, net (Note 9) | 1,600 | |||||
Lease liabilities | 1,800 | |||||
Deferred rent and incentives | $ (200) |
Leases - Components of lease co
Leases - Components of lease costs (Details) $ in Thousands | 3 Months Ended |
Mar. 31, 2019USD ($) | |
Leases [Abstract] | |
Operating lease expense | $ 341 |
Variable lease expense | 203 |
Short-term lease expense | 8 |
Total lease expense | $ 552 |
Leases - Operating Lease, Liabi
Leases - Operating Lease, Liability, Maturity (Details) $ in Thousands | Mar. 31, 2019USD ($) |
Leases [Abstract] | |
2019 | $ 1,119 |
2020 | 375 |
Total future minimum lease payments | 1,494 |
Less imputed interest | 66 |
Lease liabilities | 1,428 |
Current operating lease liabilities | 1,428 |
Non-current operating lease liabilities | $ 0 |
Leases - Lease Term and Discoun
Leases - Lease Term and Discount Rate (Details) | Mar. 31, 2019 |
Leases [Abstract] | |
Operating lease, weighted average remaining lease term | 1 year |
Operating lease, weighted average discount rate, percent | 10.00% |
Leases - Other Information (Det
Leases - Other Information (Details) $ in Thousands | 3 Months Ended |
Mar. 31, 2019USD ($) | |
Leases [Abstract] | |
Operating cash flows from operating leases | $ 363 |
Leases - Lease commitments (Det
Leases - Lease commitments (Details) $ in Thousands | Dec. 31, 2018USD ($) |
Leases [Abstract] | |
Operating Leases, Future Minimum Payments, Remainder of Fiscal Year | $ 1,482 |
Operating Leases, Future Minimum Payments, Due in Two Years | 375 |
Total minimum lease payments | $ 1,857 |
Debt - Term Loans (Narrative) (
Debt - Term Loans (Narrative) (Details) - USD ($) $ in Thousands | Sep. 12, 2017 | Mar. 31, 2019 | Mar. 31, 2018 | Dec. 31, 2018 |
Line of Credit Facility [Line Items] | ||||
Minimum assets trigger | $ 300 | |||
Minimum amount in excess of indebtedness trigger | 300 | |||
Interest expense related to the Term Loan | 396 | $ 350 | ||
2017 Term Loans | ||||
Line of Credit Facility [Line Items] | ||||
Term loan facility | $ 21,000 | $ 21,000 | $ 21,000 | |
Loss on extinguishment of debt | 700 | |||
Debt issuance costs, line of credit arrangements (less than) | $ 100 | |||
Interest rate per annum | 4.00% | |||
Final payment fee (as a percent) | 5.00% | |||
Final payment fee | $ 1,100 | |||
Interest expense related to the Term Loan | $ 400 | $ 300 | ||
2017 Term Loans | Base Rate | ||||
Line of Credit Facility [Line Items] | ||||
Debt instrument, basis spread on variable rate | 0.05% | |||
2017 Term Loans | Prepaid after to first anniversary but before second | ||||
Line of Credit Facility [Line Items] | ||||
Prepayment fee (as a percent) | 2.00% | |||
2017 Term Loans | Prepaid after second anniversary | ||||
Line of Credit Facility [Line Items] | ||||
Prepayment fee (as a percent) | 1.00% | |||
Term Loans | ||||
Line of Credit Facility [Line Items] | ||||
Repayments of debt | $ 10,000 |
Debt - Schedule of Future Minim
Debt - Schedule of Future Minimum Payments on the Term Loans (Details) - 2017 Term Loans $ in Thousands | Mar. 31, 2019USD ($) |
Year ended December 31, | |
2019 | $ 4,427 |
2020 | 9,232 |
2021 | 8,718 |
2022 | 1,754 |
Total minimum debt payments | 24,131 |
Less: Amount representing interest | (2,081) |
Less: Debt discount and deferred charges | (584) |
Less: Current portion of loan payable | (21,466) |
Loan payable, net of current portion | $ 0 |
Stockholders' Equity - Narrativ
Stockholders' Equity - Narrative (Details) | Jan. 29, 2019shares | Jan. 25, 2019$ / sharesshares | Jan. 01, 2019USD ($)shares | Aug. 10, 2017USD ($) | Jun. 27, 2017USD ($)$ / sharesshares | Jul. 25, 2016USD ($)$ / sharesshares | Jun. 21, 2016USD ($)$ / sharesshares | Mar. 31, 2019USD ($)vote$ / sharesshares | Mar. 31, 2018USD ($) | Dec. 31, 2018$ / sharesshares | Jun. 27, 2016shares |
Subsidiary, Sale of Stock [Line Items] | |||||||||||
Sale of stock, number of shares issued in transaction (in shares) | 22,188,706 | 44,788,025 | |||||||||
Share price (in dollars per share) | $ / shares | $ 1.50 | ||||||||||
Sale common stock | $ | $ 30,900,000 | ||||||||||
Common stock, par value (in dollars per share) | $ / shares | $ 0.0001 | $ 0.0001 | |||||||||
Shares issued, value | $ | $ 33,300,000 | $ 30,942,000 | $ 0 | ||||||||
Proceeds from Initial Public Offering, net of underwriters' discounts and commissions | $ | $ 64,500,000 | ||||||||||
Convertible preferred stock, shares issued upon conversion (in shares) | 10,126,118 | ||||||||||
Common stock, shares authorized (in shares) | 200,000,000 | 200,000,000 | |||||||||
Number of votes per share that common stockholders are entitled to | vote | 1 | ||||||||||
Dividends declared or paid on common stock | $ | $ 0 | ||||||||||
Public Stock Offering | |||||||||||
Subsidiary, Sale of Stock [Line Items] | |||||||||||
Sale of stock, number of shares issued in transaction (in shares) | 20,000,000 | ||||||||||
Over-Allotment Option | |||||||||||
Subsidiary, Sale of Stock [Line Items] | |||||||||||
Sale of stock, number of shares issued in transaction (in shares) | 2,188,706 | 289,633 | |||||||||
Share price (in dollars per share) | $ / shares | $ 14 | ||||||||||
Proceeds from Initial Public Offering, net of underwriters' discounts and commissions | $ | $ 3,700,000 | ||||||||||
At-The-Market Offering | |||||||||||
Subsidiary, Sale of Stock [Line Items] | |||||||||||
Sale of stock, number of shares issued in transaction (in shares) | 0 | ||||||||||
Public securities offering, amount authorized | $ | $ 200,000,000 | ||||||||||
Public stock offering, amount authorized | $ | $ 50,000,000 | ||||||||||
2017 PIPE | |||||||||||
Subsidiary, Sale of Stock [Line Items] | |||||||||||
Sale of stock, number of shares issued in transaction (in shares) | 2,750,000 | ||||||||||
Share price (in dollars per share) | $ / shares | $ 16 | ||||||||||
Common stock, par value (in dollars per share) | $ / shares | $ 0.0001 | ||||||||||
Shares issued, value | $ | $ 47,100,000 | ||||||||||
Springer Purchase Agreement | |||||||||||
Subsidiary, Sale of Stock [Line Items] | |||||||||||
Share price (in dollars per share) | $ / shares | $ 17.71 | ||||||||||
Springer Purchase Agreement | Common stock | |||||||||||
Subsidiary, Sale of Stock [Line Items] | |||||||||||
Stock issued (in shares) | 338,791 | ||||||||||
Exercise of common warrants | |||||||||||
Subsidiary, Sale of Stock [Line Items] | |||||||||||
Sale of stock, number of shares issued in transaction (in shares) | 79,130 | ||||||||||
Exercise price (in dollars per share) | $ / shares | $ 17.71 | ||||||||||
Expiration period of warrants | 5 years | ||||||||||
Share price (in dollars per share) | $ / shares | $ 0.125 | ||||||||||
IPO | |||||||||||
Subsidiary, Sale of Stock [Line Items] | |||||||||||
Sale of stock, number of shares issued in transaction (in shares) | 5,000,000 | ||||||||||
Share price (in dollars per share) | $ / shares | $ 14 | ||||||||||
Proceeds from Initial Public Offering, net of underwriters' discounts and commissions | $ | $ 60,800,000 |
Stockholders' Equity - Schedule
Stockholders' Equity - Schedule of Authorized Shares of Common Stock for Future Issuance (Details) - shares | Mar. 31, 2019 | Dec. 31, 2018 |
Class of Stock [Line Items] | ||
Total (in shares) | 8,947,568 | 5,951,523 |
Shares available for future stock incentive awards | ||
Class of Stock [Line Items] | ||
Total (in shares) | 4,012,207 | 1,586,925 |
Restricted stock units | ||
Class of Stock [Line Items] | ||
Total (in shares) | 50,000 | 0 |
Unvested restricted stock units | ||
Class of Stock [Line Items] | ||
Total (in shares) | 225,000 | 175,000 |
Outstanding common stock options | ||
Class of Stock [Line Items] | ||
Total (in shares) | 4,564,742 | 4,093,979 |
Exercise of common warrants | ||
Class of Stock [Line Items] | ||
Total (in shares) | 95,619 | 95,619 |
Stock Incentive Plans - Additio
Stock Incentive Plans - Additional Information (Narrative) (Details) - USD ($) $ / shares in Units, $ in Thousands | Mar. 25, 2019 | Jun. 21, 2016 | Mar. 31, 2019 | Mar. 31, 2018 | Dec. 31, 2018 | Sep. 25, 2018 | Dec. 31, 2008 |
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||||||
Common stock authorized and reserved for future issuance (in shares) | 8,947,568 | 5,951,523 | |||||
Stock‑based compensation expense | $ 1,180 | $ 1,153 | |||||
Shares issued, value | $ 30,942 | ||||||
Employee stock option grants | |||||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||||||
Common stock authorized and reserved for future issuance (in shares) | 4,012,207 | 1,586,925 | |||||
Estimated forfeitures rate | 10.00% | ||||||
Weighted average grant date fair value of stock options (in dollars per share) | $ 1.77 | $ 7.07 | |||||
Aggregate intrinsic value of stock options exercised | $ 100 | ||||||
Unrecognized compensation expense related to unvested employee stock options | $ 10,300 | ||||||
Weighted average period for recognition | 3 years 1 month 6 days | ||||||
Non-employee stock options | |||||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||||||
Unrecognized compensation expense related to unvested non-employee stock options | $ 1,000 | ||||||
Unrecognized compensation expense related to unvested non-employee stock options, period | 2 years | ||||||
Granted (in dollars per share) | $ 4.35 | ||||||
Unvested restricted stock units | |||||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||||||
Common stock authorized and reserved for future issuance (in shares) | 225,000 | 175,000 | |||||
Grants in period (in shares) | 100,000 | 50,000 | |||||
Reserved for issuance (in shares) | 50,000 | ||||||
Grants in period (in dollars per share) | $ 2.29 | ||||||
Shares issued (in dollars per share) | $ 5.20 | $ 6.03 | |||||
Shares issued, value | $ 100 | ||||||
The 2008 Plan and the 2016 Plan | Employee stock option grants | |||||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||||||
Issuance of common stock upon exercise of options (in shares) | 115,600 | ||||||
Aggregate intrinsic value of stock options exercised | $ 189 | ||||||
Forfeited (in shares) | 733,137 | ||||||
Granted (in shares) | 1,319,500 | ||||||
Granted (in dollars per share) | $ 2.41 | ||||||
The 2008 Plan and the 2016 Plan | Non-employee stock options | |||||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||||||
Issuance of common stock upon exercise of options (in shares) | 0 | ||||||
Aggregate intrinsic value of stock options exercised | $ 24 | ||||||
Forfeited (in shares) | 0 | ||||||
Granted (in shares) | 0 | 0 | |||||
Granted (in dollars per share) | $ 0 | ||||||
2008 Plan | |||||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||||||
Number of shares authorized for grants (in shares) | 2,213,412 | ||||||
2008 Plan | Employee stock option grants | |||||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||||||
Award vesting term | 4 years | ||||||
Award expiration term | 10 years | ||||||
2008 Plan | Employee stock option grants | Minimum | |||||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||||||
Combined voting power of participants (as a percent) | 10.00% | ||||||
2008 Plan | Employee stock option grants | Maximum | |||||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||||||
Combined voting power of participants (as a percent) | 10.00% | ||||||
2016 Plan | |||||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||||||
Number of shares authorized for grants (in shares) | 1,210,256 | ||||||
Automatic increase in the number of shares that may be issued (as a percent) | 0.04 | ||||||
Number of shares authorized, increase (in shares) | 898,871 | 893,730 | |||||
Common stock authorized and reserved for future issuance (in shares) | 1,759,539 | ||||||
2016 Plan | Employee stock option grants | |||||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||||||
Award vesting term | 4 years | ||||||
Award expiration term | 10 years | ||||||
2016 Plan | Employee stock option grants | Minimum | |||||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||||||
Combined voting power of participants (as a percent) | 10.00% | ||||||
2016 Plan | Employee stock option grants | Maximum | |||||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||||||
Combined voting power of participants (as a percent) | 10.00% | ||||||
Employment Inducement Incentive Award Plan | |||||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||||||
Number of shares authorized for grants (in shares) | 1,500,000 | ||||||
Common stock authorized and reserved for future issuance (in shares) | 2,000,000 | 1,175,000 | |||||
Grants in period (in shares) | 400,000 | ||||||
Employment Inducement Incentive Award Plan | Unvested restricted stock units | |||||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||||||
Weighted average period for recognition | 3 years 4 months 24 days | ||||||
Shares issued (in shares) | 175,000 | ||||||
Shares issued (in dollars per share) | $ 6.03 | ||||||
Shares issued, value | $ 1,100 | ||||||
Unrecognized compensation expense | $ 1,100 | ||||||
ESPP | |||||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||||||
Exercise price of incentive stock options (not less than) | 85.00% | ||||||
Automatic increase in the number of shares that may be issued (as a percent) | 0.01 | ||||||
Number of shares authorized, increase (in shares) | 224,717 | 223,432 | |||||
Common stock authorized and reserved for future issuance (in shares) | 173,076 | 752,668 | |||||
Stock‑based compensation expense | $ 100 | $ 100 | |||||
Shares issued (in shares) | 11,943 | ||||||
Tranche One | 2008 Plan | Employee stock option grants | Minimum | |||||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||||||
Exercise price of incentive stock options (not less than) | 100.00% | ||||||
Tranche One | 2016 Plan | Employee stock option grants | Minimum | |||||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||||||
Exercise price of incentive stock options (not less than) | 100.00% | ||||||
Tranche Two | 2008 Plan | Employee stock option grants | Minimum | |||||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||||||
Exercise price of incentive stock options (not less than) | 110.00% | ||||||
Tranche Two | 2016 Plan | Employee stock option grants | Minimum | |||||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||||||
Exercise price of incentive stock options (not less than) | 110.00% | ||||||
Executive Officer [Member] | |||||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||||||
Vested and expected to vest (in shares) | 60,001 | ||||||
Vested and expected to vest, exercisable (in shares) | 137,918 |
Stock Incentive Plans - Schedul
Stock Incentive Plans - Schedule of Assumptions (Details) - Employee stock option grants - $ / shares | 3 Months Ended | |
Mar. 31, 2019 | Mar. 31, 2018 | |
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||
Risk-free interest rate | 2.45% | 2.65% |
Dividend yield | 0.00% | 0.00% |
Expected term | 6 years 21 days | 6 years 7 months 20 days |
Expected volatility | 87.35% | 84.81% |
Weighted-average fair value of common stock (in dollars per share) | $ 2.41 | $ 9.53 |
Stock Incentive Plans - Summary
Stock Incentive Plans - Summary of Activity Under the 2008 Plan and the 2016 Plan (Details) - USD ($) $ / shares in Units, $ in Thousands | 3 Months Ended | 12 Months Ended | |
Mar. 31, 2019 | Mar. 31, 2018 | Dec. 31, 2018 | |
Employee Awards | |||
Aggregate intrinsic value | |||
Vested and expected to vest | $ 100 | ||
Non‑Employee Awards | |||
Weighted-average exercise price | |||
Granted (in dollars per share) | $ 4.35 | ||
The 2008 Plan and the 2016 Plan | Employee Awards | |||
Number of Options | |||
Beginning balance (in shares) | 3,681,575 | ||
Granted (in shares) | 1,319,500 | ||
Exercised (in shares) | (115,600) | ||
Forfeited (in shares) | (733,137) | ||
Ending balance (in shares) | 4,152,338 | 3,681,575 | |
Vested (in shares) | 1,071,591 | ||
Vested and expected to vest (in shares) | 3,893,328 | ||
Weighted-average exercise price | |||
Beginning balance (in dollars per share) | $ 9.49 | ||
Granted (in dollars per share) | 2.41 | ||
Exercised (in dollars per share) | 1.26 | ||
Forfeited (in dollars per share) | 10.51 | ||
Ending balance (in dollars per share) | 7.29 | $ 9.49 | |
Vested (in dollars per share) | 10.06 | ||
Vested and expected to vest (in dollars per share) | $ 7.39 | ||
Weighted-average remaining contractual term | |||
Outstanding, term | 8 years 6 months 10 days | 7 years 9 months 7 days | |
Vested, term | 5 years 11 months 23 days | ||
Vested and expected to vest, term | 8 years 5 months 19 days | ||
Aggregate intrinsic value | |||
Outstanding | $ 195 | $ 300 | |
Vested | 107 | ||
Vested and expected to vest | $ 189 | ||
The 2008 Plan and the 2016 Plan | Non‑Employee Awards | |||
Number of Options | |||
Beginning balance (in shares) | 412,404 | ||
Granted (in shares) | 0 | 0 | |
Exercised (in shares) | 0 | ||
Forfeited (in shares) | 0 | ||
Ending balance (in shares) | 412,404 | 412,404 | |
Vested (in shares) | 227,986 | ||
Vested and expected to vest (in shares) | 412,404 | ||
Weighted-average exercise price | |||
Beginning balance (in dollars per share) | $ 6.44 | ||
Granted (in dollars per share) | 0 | ||
Exercised (in dollars per share) | 0 | ||
Forfeited (in dollars per share) | 0 | ||
Ending balance (in dollars per share) | 6.44 | $ 6.44 | |
Vested (in dollars per share) | 4.21 | ||
Vested and expected to vest (in dollars per share) | $ 6.44 | ||
Weighted-average remaining contractual term | |||
Outstanding, term | 6 years 2 months 4 days | 6 years 5 months 1 day | |
Vested, term | 3 years 8 months 23 days | ||
Vested and expected to vest, term | 6 years 2 months 4 days | ||
Aggregate intrinsic value | |||
Outstanding | $ 24 | $ 28 | |
Vested | 24 | ||
Vested and expected to vest | $ 24 |
Stock Incentive Plans - Restric
Stock Incentive Plans - Restricted Stock Units (Details) - USD ($) $ / shares in Units, $ in Thousands | Mar. 25, 2019 | Mar. 31, 2019 | Mar. 31, 2018 |
Share-based Compensation Arrangement by Share-based Payment Award, Equity Instruments Other than Options, Nonvested, Weighted Average Grant Date Fair Value [Abstract] | |||
Stock‑based compensation expense | $ 1,180 | $ 1,153 | |
Unvested restricted stock units | |||
Share-based Compensation Arrangement by Share-based Payment Award, Equity Instruments Other than Options, Nonvested, Number of Shares [Roll Forward] | |||
Shares outstanding at December 31, 2018 | 175,000 | ||
Grants in period (in shares) | 100,000 | 50,000 | |
Vested in period (in shares) | 0 | ||
Reserved for issuance (in shares) | 50,000 | ||
Forfeited in period (in shares) | 0 | ||
Shares outstanding at March 31, 2019 | 275,000 | ||
Share-based Compensation Arrangement by Share-based Payment Award, Equity Instruments Other than Options, Nonvested, Weighted Average Grant Date Fair Value [Abstract] | |||
Shares outstanding at December 31, 2018 (in dollars per share) | $ 6.03 | ||
Grants in period (in dollars per share) | 2.29 | ||
Vested in period (in dollars per share) | 0 | ||
Reserved for issuance (in dollars per share) | 0 | ||
Forfeited in period (in dollars per share) | 0 | ||
Shares outstanding at March 31, 2019 (in dollars per share) | $ 5.20 |
Stock Incentive Plans - Employe
Stock Incentive Plans - Employee Stock Purchase Plan (Narrative) (Details) $ in Thousands | Jun. 21, 2016offering_periodshares | Jun. 20, 2016 | Mar. 31, 2019USD ($)shares | Mar. 31, 2018USD ($)shares | Dec. 31, 2018shares |
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||||
Common stock authorized and reserved for future issuance (in shares) | 8,947,568 | 5,951,523 | |||
Stock-based compensation expense | $ | $ 1,180 | $ 1,153 | |||
ESPP | |||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||||
Number of offering periods under the ESPP | offering_period | 2 | ||||
Term of each offering period | 6 months | ||||
Eligible compensation withheld for use (up to) (as a percent) | 25.00% | ||||
Purchase price of shares (not less than) (as a percent) | 85.00% | ||||
Common stock authorized and reserved for future issuance (in shares) | 173,076 | 752,668 | |||
Number of shares of common stock outstanding (as a percent) | 0.01 | ||||
Number of shares authorized, increase (in shares) | 224,717 | 223,432 | |||
Shares of common stock issued to employees under the ESPP (in shares) | 11,943 | ||||
Stock-based compensation expense | $ | $ 100 | $ 100 |
Stock Incentive Plans - Sched_2
Stock Incentive Plans - Schedule of Stock-Based Compensation Expense Related to Stock Options and Restricted Common Stock (Details) - USD ($) $ in Thousands | 3 Months Ended | |
Mar. 31, 2019 | Mar. 31, 2018 | |
Share-based Compensation Arrangement by Share-based Payment Award, Compensation Cost [Line Items] | ||
Total stock-based compensation expense | $ 1,180 | $ 1,153 |
Research and development | ||
Share-based Compensation Arrangement by Share-based Payment Award, Compensation Cost [Line Items] | ||
Total stock-based compensation expense | 519 | 511 |
General and administrative | ||
Share-based Compensation Arrangement by Share-based Payment Award, Compensation Cost [Line Items] | ||
Total stock-based compensation expense | $ 661 | $ 642 |
Revenue Arrangements - Narrativ
Revenue Arrangements - Narrative (Details) | Jan. 01, 2019shares | Oct. 31, 2017USD ($)$ / sharesshares | Jun. 06, 2017USD ($)$ / sharesshares | Dec. 02, 2016USD ($)targetobligationcontract | Nov. 28, 2014USD ($) | Dec. 31, 2016USD ($)shares | May 31, 2014USD ($) | Mar. 31, 2019USD ($)agreementshares | Dec. 31, 2018USD ($) | Jun. 30, 2018USD ($) | Mar. 31, 2018USD ($)shares | Dec. 31, 2017USD ($) | Mar. 31, 2018USD ($)shares | Jan. 25, 2019$ / shares | Jan. 01, 2018USD ($) | Mar. 31, 2017$ / shares | Nov. 25, 2008 |
Disaggregation of Revenue [Line Items] | |||||||||||||||||
Number of additional targets | target | 4 | ||||||||||||||||
Sale of stock, number of shares issued in transaction (in shares) | shares | 22,188,706 | 44,788,025 | |||||||||||||||
Sale common stock | $ 30,900,000 | ||||||||||||||||
Share price (in dollars per share) | $ / shares | $ 1.50 | ||||||||||||||||
Deferred revenue related to agreement | 16,408,000 | $ 16,903,000 | |||||||||||||||
Deferred revenue, current portion | 959,000 | 959,000 | |||||||||||||||
Deferred revenue, net of current portion | 13,816,000 | 13,818,000 | |||||||||||||||
Remaining performance obligation | 8,600,000 | ||||||||||||||||
Current assets | (59,528,000) | (42,076,000) | |||||||||||||||
Accumulated deficit | 292,477,000 | 280,403,000 | |||||||||||||||
Revenue recognized | 10,000 | ||||||||||||||||
Adoption of new accounting principle | $ 1,830,000 | ||||||||||||||||
Grant and collaboration revenue | 10,000 | $ 0 | |||||||||||||||
Reimbursement invoices | 500,000 | ||||||||||||||||
Other liabilities | 1,600,000 | ||||||||||||||||
Spark Letter Agreement | |||||||||||||||||
Disaggregation of Revenue [Line Items] | |||||||||||||||||
Sale common stock | $ 2,500,000 | ||||||||||||||||
Premium of average daily VWAP (as a percent) | 115.00% | ||||||||||||||||
Deferred revenue related to agreement | $ 2,500,000 | ||||||||||||||||
Aggregate purchase price | $ 5,000,000 | ||||||||||||||||
Number of shares authorized to be issued pursuant to the Stock Purchase Agreement (in shares) | shares | 205,254 | 324,362 | |||||||||||||||
Fair value of initial purchase of common stock combined with the embedded future stock Acquisition Rights | $ 2,700,000 | ||||||||||||||||
Aggregate purchase price per share (in dollar per share) | $ / shares | $ 24.36 | $ 15.41 | |||||||||||||||
First Acquisition Right | |||||||||||||||||
Disaggregation of Revenue [Line Items] | |||||||||||||||||
Aggregate purchase price | $ 5,000,000 | ||||||||||||||||
Skolkovo | |||||||||||||||||
Disaggregation of Revenue [Line Items] | |||||||||||||||||
Deferred revenue related to agreement | 100,000 | 200,000 | |||||||||||||||
Aggregate amount of grant | $ 2,700,000 | ||||||||||||||||
Percentage of estimated total cost of research plan | 48.50% | ||||||||||||||||
Remaining percentage of estimated costs to be contributed by the Company | 51.50% | ||||||||||||||||
Payments received | $ 2,000,000 | ||||||||||||||||
Grants from entities, unused grant funds | 100,000 | $ 100,000 | |||||||||||||||
Overspent costs | $ 100,000 | ||||||||||||||||
Period after completion of project when Company may be required to reimburse the funds received | 3 years | ||||||||||||||||
Second Acquisition Right | |||||||||||||||||
Disaggregation of Revenue [Line Items] | |||||||||||||||||
Share price (in dollars per share) | $ / shares | $ 24.36 | ||||||||||||||||
Premium of average daily VWAP (as a percent) | 115.00% | ||||||||||||||||
Consecutive calendar days leading up to and ending on the day prior to the Contract Date | 30 days | ||||||||||||||||
Aggregate price of shares Spark will have the right to purchase | $ 5,000,000 | ||||||||||||||||
Spark License Agreement | |||||||||||||||||
Disaggregation of Revenue [Line Items] | |||||||||||||||||
Upfront cash payment | 10,000,000 | ||||||||||||||||
Aggregate additional payments due within twelve months | $ 5,000,000 | ||||||||||||||||
Term loan number of payments | contract | 2 | ||||||||||||||||
Two payments due within 12 months of contract date | $ 2,500,000 | ||||||||||||||||
Number of additional targets | target | 4 | ||||||||||||||||
Variable fee the Company is eligible to receive for each additional target option elected | $ 2,000,000 | ||||||||||||||||
Election period to exercise additional targets | 3 years | ||||||||||||||||
Additional development and regulatory milestone payments | $ 65,000,000 | ||||||||||||||||
Commercialization milestone payments | 365,000,000 | ||||||||||||||||
Sales milestone payments | $ 255,000,000 | ||||||||||||||||
Period after first commercial sale when the Company is eligible to receive royalties | 10 years | ||||||||||||||||
Period for prior written notice to terminate license | 90 days | ||||||||||||||||
Sale of stock, number of shares issued in transaction (in shares) | shares | 197,238 | ||||||||||||||||
Sale common stock | $ 5,000,000 | ||||||||||||||||
Share price (in dollars per share) | $ / shares | $ 25.35 | ||||||||||||||||
Premium of average daily VWAP (as a percent) | 115.00% | ||||||||||||||||
Deferred revenue related to agreement | 14,700,000 | 14,700,000 | 14,700,000 | ||||||||||||||
Deferred revenue, current portion | 1,000,000 | 800,000 | 800,000 | ||||||||||||||
Deferred revenue, net of current portion | $ 13,700,000 | $ 13,900,000 | $ 13,900,000 | ||||||||||||||
Consecutive calendar days leading up to and ending on the day prior to the Contract Date | 30 days | ||||||||||||||||
Number of shares authorized to be issued pursuant to the Stock Purchase Agreement (in shares) | shares | 2,758,112 | 2,758,112 | |||||||||||||||
Number of agreements combined and evaluated into a single agreement | agreement | 2 | ||||||||||||||||
Fair value of initial purchase of common stock combined with the embedded future stock Acquisition Rights | $ 2,700,000 | ||||||||||||||||
Remaining performance obligation | 12,300,000 | $ 2,300,000 | |||||||||||||||
Performance obligation per each option | 1,300,000 | ||||||||||||||||
Incremental costs of obtaining a contract | 2,600,000 | ||||||||||||||||
Spark License Agreement | MIT | |||||||||||||||||
Disaggregation of Revenue [Line Items] | |||||||||||||||||
License and option agreement, additional sub-license payment received liability | $ 2,200,000 | ||||||||||||||||
License and option agreement, payments made relative to calculated premium paid for initial equity investment made under the purchase agreement | 400,000 | $ 400,000 | |||||||||||||||
Spark License Agreement | Consideration for Promises | |||||||||||||||||
Disaggregation of Revenue [Line Items] | |||||||||||||||||
Upfront cash payment | 15,000,000 | ||||||||||||||||
Spark License Agreement | Development Milestones | |||||||||||||||||
Disaggregation of Revenue [Line Items] | |||||||||||||||||
Additional development and regulatory milestone payments | 35,000,000 | ||||||||||||||||
Spark License Agreement | Regulatory Milestones | |||||||||||||||||
Disaggregation of Revenue [Line Items] | |||||||||||||||||
Additional development and regulatory milestone payments | 30,000,000 | ||||||||||||||||
Spark License Agreement | Commercial Milestones | |||||||||||||||||
Disaggregation of Revenue [Line Items] | |||||||||||||||||
Commercialization milestone payments | $ 110,000,000 | ||||||||||||||||
Spark License Agreement | License and Supply Obligation | |||||||||||||||||
Disaggregation of Revenue [Line Items] | |||||||||||||||||
Number of obligations | obligation | 5 | ||||||||||||||||
Remaining performance obligation | $ 7,100,000 | ||||||||||||||||
Spark License Agreement | Discount on Option Obligation | |||||||||||||||||
Disaggregation of Revenue [Line Items] | |||||||||||||||||
Number of obligations | obligation | 4 | ||||||||||||||||
Remaining performance obligation | $ 5,200,000 | ||||||||||||||||
First Grant | NIH | |||||||||||||||||
Disaggregation of Revenue [Line Items] | |||||||||||||||||
Aggregate amount of grant | $ 8,100,000 | ||||||||||||||||
Period after completion of project when Company may be required to reimburse the funds received | 3 years | ||||||||||||||||
Accumulated deficit | |||||||||||||||||
Disaggregation of Revenue [Line Items] | |||||||||||||||||
Adoption of new accounting principle | 1,830,000 | ||||||||||||||||
Accumulated deficit | ASU 2014-09 | Skolkovo | |||||||||||||||||
Disaggregation of Revenue [Line Items] | |||||||||||||||||
Adoption of new accounting principle | $ 1,800,000 | ||||||||||||||||
Grant Revenue | |||||||||||||||||
Disaggregation of Revenue [Line Items] | |||||||||||||||||
Grant and collaboration revenue | 100,000 | ||||||||||||||||
Grant Revenue | NIDA | |||||||||||||||||
Disaggregation of Revenue [Line Items] | |||||||||||||||||
Grant and collaboration revenue | $ 900,000 | $ 7,200,000 | |||||||||||||||
Restatement Adjustment | Error Recognized Upon the Initial Adoption of ASC 606 | |||||||||||||||||
Disaggregation of Revenue [Line Items] | |||||||||||||||||
Current assets | 200,000 | ||||||||||||||||
Long-term assets | 2,400,000 | ||||||||||||||||
Accumulated deficit | $ 2,600,000 | ||||||||||||||||
Minimum | MIT | |||||||||||||||||
Disaggregation of Revenue [Line Items] | |||||||||||||||||
Percentage of sublicense income | 10.00% | ||||||||||||||||
Maximum | MIT | |||||||||||||||||
Disaggregation of Revenue [Line Items] | |||||||||||||||||
Percentage of sublicense income | 30.00% |
Revenue Arrangements - Transact
Revenue Arrangements - Transaction Price Allocated to Future Performance Obligation (Details) - USD ($) $ in Millions | Mar. 31, 2019 | Dec. 02, 2016 |
Revenue from Contract with Customer [Abstract] | ||
Remaining performance obligation | $ 8.6 | |
Remaining performance obligation, percentage | 8.90% | |
Revenue, Remaining Performance Obligation, Expected Timing of Satisfaction, Start Date [Axis]: 2019-04-01 | ||
Revenue, Remaining Performance Obligation, Expected Timing of Satisfaction [Line Items] | ||
Remaining performance obligation, period | 12 months | |
Spark License Agreement | ||
Revenue from Contract with Customer [Abstract] | ||
Remaining performance obligation | $ 2.3 | $ 12.3 |
Spark License Agreement | License and Supply Obligation | ||
Revenue from Contract with Customer [Abstract] | ||
Remaining performance obligation | $ 7.1 | |
Spark License Agreement | License and Supply Obligation | Revenue, Remaining Performance Obligation, Expected Timing of Satisfaction, Start Date [Axis]: 2016-12-03 | ||
Revenue, Remaining Performance Obligation, Expected Timing of Satisfaction [Line Items] | ||
Remaining performance obligation, period | 4 years |
Revenue Arrangements - Schedule
Revenue Arrangements - Schedule of Changes in Contract Liabilities (Details) - USD ($) $ in Thousands | 3 Months Ended | |
Mar. 31, 2019 | Mar. 31, 2019 | |
Contract liabilities: | ||
Deferred revenue, beginning of period | $ 14,777 | |
Other liabilities, beginning of period | 2,126 | |
Contract liabilities, beginning of period | 16,903 | |
Deferred revenue, additions | 8 | |
Other liabilities, additions | 0 | |
Contract liabilities, additions | 8 | |
Deferred revenue, deductions | (10) | |
Other liabilities, deductions | (493) | |
Contract liabilities, deductions | (503) | |
Deferred revenue, end of period | 14,775 | |
Other liabilities, end of period | 2,126 | $ 1,633 |
Contract liabilities, end of period | $ 16,408 | |
Other liabilities, current portion | 800 | |
Other liabilities, noncurrent portion | $ 800 |
- Narrative (Details)
- Narrative (Details) - USD ($) | Jan. 29, 2019 | Jan. 01, 2019 | Jul. 25, 2016 | Mar. 31, 2019 | Mar. 31, 2018 | Jan. 25, 2019 |
Related Party Transaction [Line Items] | ||||||
Sale of stock, number of shares issued in transaction (in shares) | 22,188,706 | 44,788,025 | ||||
Share price (in dollars per share) | $ 1.50 | |||||
Shares issued, value | $ 33,300,000 | $ 30,942,000 | $ 0 | |||
Director | Quarterly payment | ||||||
Related Party Transaction [Line Items] | ||||||
Related party transaction, amounts of transaction | 85,000 | |||||
Founders | ||||||
Related Party Transaction [Line Items] | ||||||
Consulting services expenses | $ 100,000 | $ 100,000 | ||||
Over-Allotment Option | ||||||
Related Party Transaction [Line Items] | ||||||
Sale of stock, number of shares issued in transaction (in shares) | 2,188,706 | 289,633 | ||||
Share price (in dollars per share) | $ 14 | |||||
Non-employee stock options | ||||||
Related Party Transaction [Line Items] | ||||||
Options granted (in shares) | 75,000 | |||||
Granted (in dollars per share) | $ 4.35 |
- Number of Shares of Common St
- Number of Shares of Common Stock Purchased (Details) - USD ($) | Jan. 01, 2019 | Mar. 31, 2019 | Mar. 31, 2018 |
Related Party Transaction [Line Items] | |||
Stock issued (in shares) | 22,188,706 | 44,788,025 | |
Shares issued, value | $ 33,300,000 | $ 30,942,000 | $ 0 |
Timothy A. Springer, Ph.D. | Director | |||
Related Party Transaction [Line Items] | |||
Stock issued (in shares) | 4,000,000 | ||
Shares issued, value | $ 6,000,000 | ||
Entities affiliated with NanoDimension | |||
Related Party Transaction [Line Items] | |||
Stock issued (in shares) | 1,666,666 | ||
Shares issued, value | $ 2,499,999 | ||
Entities affiliated with OrbiMed Advisors | |||
Related Party Transaction [Line Items] | |||
Stock issued (in shares) | 1,333,333 | ||
Shares issued, value | $ 1,999,999.50 | ||
Entities affiliated with Polaris | |||
Related Party Transaction [Line Items] | |||
Stock issued (in shares) | 666,666 | ||
Shares issued, value | $ 999,999 | ||
SAF-BND Trust (affiliate of Omid Farokhzad, M.D.) | |||
Related Party Transaction [Line Items] | |||
Stock issued (in shares) | 83,333 | ||
Shares issued, value | $ 124,999.50 | ||
Chafen Lu (Timothy Springer’s wife) | |||
Related Party Transaction [Line Items] | |||
Stock issued (in shares) | 66,666 | ||
Shares issued, value | $ 99,999 | ||
Jed Springer (Timothy Springer’s brother) | |||
Related Party Transaction [Line Items] | |||
Stock issued (in shares) | 1,000 | ||
Shares issued, value | $ 1,500 |
Technology License Agreements -
Technology License Agreements - MIT (Narrative) (Details) - USD ($) | Nov. 25, 2008 | Mar. 31, 2019 | Mar. 31, 2018 |
Spark License Agreement | |||
Collaborative Arrangements and Non-collaborative Arrangement Transactions [Line Items] | |||
Contractual payments defined in the Exclusive Patent License agreement | $ 0 | ||
MIT | |||
Collaborative Arrangements and Non-collaborative Arrangement Transactions [Line Items] | |||
Payment amount upon achievement of defined clinical milestones | $ 1,500,000 | ||
MIT | Spark License Agreement | |||
Collaborative Arrangements and Non-collaborative Arrangement Transactions [Line Items] | |||
Contractual payments defined in the Exclusive Patent License agreement | 2,200,000 | ||
License and option agreement, payments made relative to calculated premium paid for initial equity investment made under the purchase agreement | $ 400,000 | $ 400,000 | |
MIT | Minimum | |||
Collaborative Arrangements and Non-collaborative Arrangement Transactions [Line Items] | |||
Percentage of sublicense income | 10.00% | ||
MIT | Maximum | |||
Collaborative Arrangements and Non-collaborative Arrangement Transactions [Line Items] | |||
Percentage of sublicense income | 30.00% |
Technology License Agreements_2
Technology License Agreements - Shenyang Sunshine Pharmaceutical Co., Ltd (Narrative) (Details) - 3SBio License $ in Millions | 1 Months Ended |
May 31, 2014USD ($) | |
Collaborative Arrangements and Non-collaborative Arrangement Transactions [Line Items] | |
Period after approval to commercialize product | 48 months |
Aggregate amount of upfront and milestone-based payments | $ 3 |
Aggregate amount for future payments upon achievement of clinical and regulatory approval milestones for products containing SVP technology | 21 |
Aggregate amount for future payments upon achievement of clinical and regulatory approval milestones for products without SVP technology | $ 41.5 |
Maximum paid on tiered royalties (percent) | 10.00% |
Period for prior written notice to terminate license | 60 days |
Technology License Agreements_3
Technology License Agreements - Massachusetts Eye and Ear Infirmary and The Schepens Eye Research Institute, Inc. (Narrative) (Details) - MEE | 1 Months Ended | 3 Months Ended |
May 31, 2016USD ($)product | Mar. 31, 2019USD ($) | |
Collaborative Arrangements and Non-collaborative Arrangement Transactions [Line Items] | ||
License fees due under agreement | $ 400,000 | |
Accrued license fees | $ 0 | |
Minimum | ||
Collaborative Arrangements and Non-collaborative Arrangement Transactions [Line Items] | ||
Minimum number of products for each target sequence | product | 1 | |
Payment under development milestone method | $ 4,200,000 | |
Payment under sales milestone method | 50,000,000 | |
Maximum | ||
Collaborative Arrangements and Non-collaborative Arrangement Transactions [Line Items] | ||
Payment under development milestone method | 37,000,000 | |
Payment under sales milestone method | $ 70,000,000 |
Income Taxes (Details)
Income Taxes (Details) - USD ($) | Mar. 31, 2019 | Jan. 22, 2019 |
Income Tax Holiday [Line Items] | ||
Unrecognized tax benefits | $ 0 | |
Unrecognized tax benefits, income tax penalties and interest accrued | $ 0 | |
Domestic And State Tax Authority | ||
Income Tax Holiday [Line Items] | ||
Operating loss carryforwards, subject to expiration | $ 49,500,000 |
Defined Contribution Plan (Deta
Defined Contribution Plan (Details) - USD ($) $ in Millions | 3 Months Ended | |
Mar. 31, 2019 | Mar. 31, 2018 | |
Retirement Benefits [Abstract] | ||
Vesting period | 4 years | |
Employer contribution made | $ 0.1 |