Document and Entity Information
Document and Entity Information - shares | 9 Months Ended | |
Sep. 30, 2016 | Nov. 08, 2016 | |
Document And Entity Information [Abstract] | ||
Document Type | 10-Q | |
Amendment Flag | false | |
Document Period End Date | Sep. 30, 2016 | |
Document Fiscal Year Focus | 2,016 | |
Document Fiscal Period Focus | Q3 | |
Trading Symbol | HSGX | |
Entity Registrant Name | Histogenics Corporation | |
Entity Central Index Key | 1,372,299 | |
Current Fiscal Year End Date | --12-31 | |
Entity Filer Category | Smaller Reporting Company | |
Entity Common Stock, Shares Outstanding | 15,930,708 |
Condensed Consolidated Balance
Condensed Consolidated Balance Sheets - USD ($) $ in Thousands | Sep. 30, 2016 | Dec. 31, 2015 |
Current assets: | ||
Cash and cash equivalents | $ 37,994 | $ 30,915 |
Prepaid expenses and other current assets | 201 | 321 |
Total current assets | 38,195 | 31,236 |
Property and equipment, net | 4,263 | 5,213 |
Intangible asset, net | 200 | 200 |
Restricted cash | 137 | 137 |
Total assets | 42,795 | 36,786 |
Current liabilities: | ||
Accounts payable | 1,665 | 2,024 |
Accounts payable due to Intrexon Corporation | 135 | 229 |
Accrued expenses | 1,484 | 1,444 |
Accrued expenses due to Intrexon Corporation | 2,802 | 1,546 |
Current portion of deferred rent | 133 | 126 |
Current portion of deferred lease incentive | 407 | 407 |
Current portion of equipment loan | 583 | 583 |
Total current liabilities | 7,209 | 6,359 |
Deferred rent, long-term | 349 | 451 |
Deferred lease incentive, long-term | 712 | 1,017 |
Equipment loan, long-term | 324 | 761 |
Warrant liability | 30,165 | |
Total liabilities | 38,759 | 8,588 |
Commitments and contingencies (Note 5) | ||
Stockholders' equity: | ||
Preferred stock, $0.01 par value; authorized shares-10,000,000 at September 30, 2016 and December 31, 2015; 24,158.8693 shares issued and outstanding at September 30, 2016 and 0 shares issued and outstanding at December 31, 2015 | ||
Common stock, $0.01 par value; authorized shares-100,000,000 at September 30, 2016 and December 31, 2015; 15,871,965 shares issued and outstanding at September 30, 2016 and 13,273,470 shares issued and outstanding at December 31, 2015 | 159 | 132 |
Additional paid-in capital | 194,713 | 193,631 |
Accumulated deficit | (190,836) | (165,565) |
Total stockholders' equity | 4,036 | 28,198 |
Total liabilities and stockholders' equity | $ 42,795 | $ 36,786 |
Condensed Consolidated Balance3
Condensed Consolidated Balance Sheets (Parenthetical) - $ / shares | Sep. 30, 2016 | Dec. 31, 2015 |
Statement of Financial Position [Abstract] | ||
Preferred stock, par value | $ 0.01 | $ 0.01 |
Preferred stock, shares authorized | 10,000,000 | 10,000,000 |
Preferred stock, shares issued | 24,158.8693 | 0 |
Preferred stock, shares outstanding | 24,158.8693 | 0 |
Common stock, par value | $ 0.01 | $ 0.01 |
Common stock, shares authorized | 100,000,000 | 100,000,000 |
Common stock, shares issued | 15,871,965 | 13,273,470 |
Common stock, shares outstanding | 15,871,965 | 13,273,470 |
Condensed Consolidated Statemen
Condensed Consolidated Statements of Operations - USD ($) $ in Thousands | 3 Months Ended | 9 Months Ended | ||
Sep. 30, 2016 | Sep. 30, 2015 | Sep. 30, 2016 | Sep. 30, 2015 | |
Income Statement [Abstract] | ||||
Revenue | $ 0 | $ 0 | $ 0 | $ 0 |
Operating expenses: | ||||
Research and development | 4,880 | 5,848 | 16,260 | 17,470 |
General and administrative | 1,768 | 2,191 | 6,141 | 6,035 |
Total operating expenses | 6,648 | 8,039 | 22,401 | 23,505 |
Loss from operations | (6,648) | (8,039) | (22,401) | (23,505) |
Other (expense) income: | ||||
Interest expense, net | (20) | (23) | (55) | (111) |
Other expense, net | (130) | (16) | (298) | (59) |
Warrant expense | (3,056) | (3,056) | (15) | |
Change in fair value of warrant liability | 539 | 539 | ||
Total other expense, net | (2,667) | (39) | (2,870) | (170) |
Net loss | (9,315) | (8,078) | (25,271) | (23,675) |
Loss attributable to common stockholders-basic and diluted | $ (9,234) | $ (8,078) | $ (25,197) | $ (23,675) |
Loss per common share-basic and diluted | $ (0.70) | $ (0.61) | $ (1.90) | $ (1.79) |
Weighted-average shares used to compute loss per common share-basic and diluted | 13,297,546 | 13,238,997 | 13,279,833 | 13,218,765 |
Condensed Consolidated Stateme5
Condensed Consolidated Statements of Cash Flows - USD ($) $ in Thousands | 9 Months Ended | |
Sep. 30, 2016 | Sep. 30, 2015 | |
CASH FLOWS FROM OPERATING ACTIVITIES: | ||
Net loss | $ (25,271) | $ (23,675) |
Adjustments to reconcile net loss to net cash used in operating activities: | ||
Depreciation | 1,267 | 1,182 |
Deferred rent and lease incentive | (400) | (191) |
Stock-based compensation | 1,080 | 854 |
Change in fair value of warrant | (539) | |
Warrant expense | 3,056 | 15 |
Changes in operating assets and liabilities: | ||
Prepaid expenses and other current assets | 120 | 431 |
Other non-current assets | 467 | |
Accounts payable | (358) | (3,139) |
Accounts payable due to Intrexon Corporation | (94) | 253 |
Accrued expenses | 40 | (1,545) |
Accrued expenses due to Intrexon Corporation | 1,256 | 2,311 |
Net cash used in operating activities | (19,843) | (23,037) |
CASH FLOWS FROM INVESTING ACTIVITIES: | ||
Purchases of property and equipment | (317) | (1,818) |
Net cash used in investing activities | (317) | (1,818) |
CASH FLOWS FROM FINANCING ACTIVITIES: | ||
Proceeds from issuance of common stock, preferred stock and warrants, net of issuance costs | 27,674 | |
Proceeds from overallotment, net of issuance costs of $377 | 4,738 | |
Repayments on equipment term loan | (437) | (260) |
Proceeds from exercise of stock options | 2 | 40 |
Net cash provided by financing activities | 27,239 | 4,518 |
Net increase(decrease) in cash and cash equivalents | 7,079 | (20,337) |
Cash and cash equivalents-Beginning of period | 30,915 | 58,060 |
Cash and cash equivalents-End of period | 37,994 | $ 37,723 |
Supplemental Disclosure of Non-Cash Items: | ||
Fair market value of private placement warrants at issuance | $ 30,704 |
Condensed Consolidated Stateme6
Condensed Consolidated Statements of Cash Flows (Parenthetical) $ in Thousands | 9 Months Ended |
Sep. 30, 2016USD ($) | |
Statement of Cash Flows [Abstract] | |
Issuance costs | $ 377 |
Nature of Business
Nature of Business | 9 Months Ended |
Sep. 30, 2016 | |
Organization, Consolidation and Presentation of Financial Statements [Abstract] | |
Nature of Business | 1. NATURE OF BUSINESS Organization Histogenics Corporation (the “Company”) was incorporated under the laws of the Commonwealth of Massachusetts on June 28, 2000 and has its principal operations in Waltham, Massachusetts. In 2006, the Company’s board of directors approved a corporate reorganization pursuant to which the Company incorporated as a Delaware corporation. The Company is a regenerative medicine company engaged in developing and commercializing products in the musculoskeletal segment of the marketplace. The Company combines cell therapy and tissue engineering technologies to develop products for tissue repair and regeneration and is initially focused on patients suffering from cartilage-derived pain and immobility. The Company’s most advanced product, NeoCart, is currently in a Phase 3 clinical trial in the United States (the “U.S.”) under a special protocol assessment with the U.S. Food and Drug Administration (“FDA”) for the treatment of knee cartilage damage. On May 13, 2011, the Company completed the acquisition of ProChon Biotech Ltd. (“ProChon”), a privately-held biotechnology company focused on modulating the fibroblast growth factor system for consideration of $2,224 to enable it to create more effective solutions for tissue regeneration. ProChon’s products combine cell regeneration technologies with proprietary growth factors and biocompatible scaffolds to restore injured or chronically damaged tissues. The acquisition of ProChon provided the Company with access to a significant portfolio of intellectual property, including proprietary cell growth factors, in addition to furthering opportunities for the use of biomaterials to create more effective solutions for regenerating human tissue. The acquisition led to the initial recognition of goodwill, which was subsequently written off in 2011, and intangible assets including IPR&D and a licensing agreement which have been impaired as discussed in Note 2. On December 18, 2014, the Company formed a wholly owned subsidiary, Histogenics Securities Corporation, under the laws of the Commonwealth of Massachusetts. On September 29, 2016, the Company closed a private placement of common stock, preferred stock and warrants, contemplated by a securities purchase agreement dated September 15, 2016, with certain institutional and accredited investors. The net proceeds after deducting placement agent fees and other transaction-related expenses was $27.7 million. (See Note 6 for further discussion of the private placement.) Since its inception, the Company has devoted substantially all of its efforts to product development, recruiting management and technical staff, raising capital, starting up production and building infrastructure and has not yet generated revenues from its planned principal operations. Expenses have primarily been for research and development and related administrative costs. The Company is subject to a number of risks. The developmental nature of its activities is such that significant inherent risks exist in the Company’s operations. Principal among these risks are the successful development of therapeutics, successfully enrolling patients in its clinical trials in a timely manner, obtaining regulatory approval for any of its product candidates in any jurisdiction, compliance with government regulations, ability to obtain adequate financing, protection of proprietary therapeutics, fluctuations in operating results, dependence on key personnel and collaborative partners, adoption of the Company’s products by the physician community, rapid technological changes inherent in the markets targeted, and substitute products and competition from larger companies. The condensed consolidated financial statements have been prepared on a going-concern basis, which contemplates the realization of assets and the satisfaction of liabilities in the normal course of business. As shown in the accompanying condensed consolidated financial statements, the Company has incurred losses and cash flow deficits from operations for the nine months ended September 30, 2016 and 2015. The Company has financed operations to date primarily through private placements of equity securities, including the sale of common stock and preferred stock, and the related issuance of warrants in September 2016, the issuance of common stock in the initial public offering completed in December 2014, and borrowings under debt agreements. The Company has incurred losses and negative cash flows from operations resulting in an accumulated deficit at September 30, 2016 of $190.8 million. The Company anticipates that it will continue to incur net losses for the next several years. The Company believes that its existing cash and cash equivalents will be sufficient to fund its projected cash needs into the middle of 2018. The Company will require additional capital to complete the filing of a biologics license application with the FDA and commercialize NeoCart, if approved, and for the future development of its existing product candidates. Basis of Accounting The condensed consolidated financial statements are unaudited and have been prepared in conformity with accounting principles generally accepted in the United States of America (“U.S. GAAP”). However, they do not include all of the information and footnotes required by GAAP for complete financial statements. These interim condensed consolidated financial statements, in the opinion of the Company’s management, reflect all normal recurring adjustments necessary for a fair presentation of the Company’s financial position and results of operations for the interim periods ended September 30, 2016 and 2015. The results of operations for the interim periods are not necessarily indicative of the results of operations to be expected for the full year. These interim financial statements should be read in conjunction with the audited financial statements as of and for the year ended December 31, 2015, and the notes thereto, which are included in the Company’s Annual Report on Form 10-K, filed with the Securities and Exchange Commission (the “SEC”) on March 10, 2016. The condensed consolidated financial statements include the accounts of Histogenics Corporation and its wholly-owned subsidiaries, ProChon and Histogenics Securities Corporation. All significant intercompany accounts and transactions are eliminated in consolidation. |
Summary of Significant Accounti
Summary of Significant Accounting Policies | 9 Months Ended |
Sep. 30, 2016 | |
Accounting Policies [Abstract] | |
Summary of Significant Accounting Policies | 2. SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES During the nine months ended September 30, 2016, there have been no material changes to the significant accounting policies described in the Company’s audited financial statements as of and for the year ended December 31, 2015, and the notes thereto, which are included in the Annual Report on Form 10-K, except as noted below. Reclassifications The Company has reclassified certain prior period amounts to conform to the current period presentation. The amounts reclassified impact Accounts Payable and Accrued Expenses and Accounts Payable due to Intrexon Corporation (“Intrexon”) and Accrued Expenses due to Intrexon for the nine months ended September 30, 2015 and the year ended December 31, 2015. Segment and Geographic Information Information about the Company’s operations in different geographic regions is presented in the tables below: September 30, December 31, 2016 2015 Long-lived assets: United States $ 4,257 $ 5,204 Israel 6 9 Total long-lived assets $ 4,263 $ 5,213 Fair Value Measurements The carrying amounts reported in the Company’s condensed consolidated financial statements for cash and cash equivalents, accounts payable and accrued liabilities approximate their respective fair values because of the short-term nature of these accounts. As a basis for determining the fair value of certain of the Company’s financial instruments, the Company utilizes a three-tier value hierarchy, which prioritizes the inputs used in measuring fair value as follows: Level 1 Level 2 Level 3 The Company had no assets or liabilities classified as Level 1 or Level 2 as of September 30, 2016 and December 31, 2015, other than the money market fund described in the “Cash and Cash Equivalents” section below, and there were no material re-measurements of fair value with respect to financial assets and liabilities during the periods presented, other than those assets and liabilities that are measured at fair value on a recurring basis. Other than the warrants issued in connection with the private placement transaction which closed on September 29, 2016, the Company had no assets or liabilities classified as Level 3 as of September 30, 2016. There were no assets or liabilities classified as Level 3 as of December 31, 2015. Transfers are calculated on values as of the transfer date. There were no transfers between Levels 1, 2 and 3 during the nine months ended September 30, 2016 and 2015. The fair value of the warrants was determined using a Monte Carlo simulation model. This model incorporated several assumptions at each valuation date including: the price of the Company’s common stock on the date of valuation, the historical volatility of the price of the Company’s common stock, the remaining contractual term of the warrant and estimates of the probability of a fundamental transaction occurring. (See Note 6 for further discussion of the private placement) This valuation is considered a Level 3 valuation. Description Total Quoted prices in active markets (Level 1) Significant other observable (Level 2) Significant unobservable inputs (Level 3) September 30, 2016 Assets: Money market funds $ 7,790 $ 7,790 $ — $ — Liabilities: Warrant liability $ 30,165 $ — $ — $ 30,165 December 31, 2015 Money market funds $ 25,764 $ 25,764 $ — $ — The following table provides a reconciliation of all liabilities measured at fair value using Level 3 significant unobservable inputs: As of September 30, 2016 Beginning balance $ — Issuance of warrants, 30,704 Change in fair value of warrant liability (539 ) Ending balance $ 30,165 Cash and Cash Equivalents The Company considers all highly liquid securities with original maturities of three months or less from the date of purchase to be cash equivalents. As of September 30, 2016, cash and cash equivalents comprise cash deposits of $30,204 and money market funds of $7,790. The money market funds are measured at fair value on a recurring basis based on quoted market prices. Intangible Asset As of September 30, 2016 and December 31, 2015, the Company’s intangible asset consists of acquired in-process research and development (“IPR&D”). For the nine months ended September 30, 2016 and 2015, the Company determined that there were no triggering events indicating impairment of its IPR&D. Intangible assets, net of accumulated impairment charges, are summarized as follows: As of September 30, 2016 As of December 31, 2015 Cost Accumulated Impairment Net Book Value Cost Accumulated Impairment Net Book Value IPR&D $ 630 $ (430 ) $ 200 $ 630 $ (430 ) $ 200 $ 630 $ (430 ) $ 200 $ 630 $ (430 ) $ 200 Stock-Based Compensation The Company accounts for stock options and restricted stock based on their grant date fair value and recognizes compensation expense on a straight-line basis over their vesting period. The Company estimates the fair value of stock options as of the date of grant using the Black-Scholes option pricing model, with the exception of stock options that include a market condition, and of restricted stock based on the fair value of the underlying common stock as of the date of grant or the value of the services provided, whichever is more readily determinable. The Company is also required to estimate forfeitures at the time of grant, and revise those estimates in subsequent periods if actual forfeitures differ from its estimates. The Company uses historical data to estimate pre-vesting option forfeitures and records stock-based compensation expense only for those awards that are expected to vest. 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 revised. Stock-based compensation expense is classified as research and development or general and administrative based on the grantee’s respective compensation classification. For stock option grants with vesting triggered by the achievement of performance-based milestones, the expense is recorded over the remaining service period after the point when the achievement of the milestone is probable or the performance condition has been achieved. For stock option grants with both performance-based milestones and market conditions, expense is recorded over the derived service period after the point when the achievement of the performance-based milestone is probable or the performance condition has been achieved. For stock option grants with market conditions, the expense is calculated using the Monte Carlo model based on the grant date fair value of the option and is recorded on a straight line basis over the requisite service period, which represents the derived service period and accelerated when the market condition is satisfied. The Company did not issue awards with market conditions during the three and nine months ended September 30, 2016. The Company accounts for stock options and restricted stock awards to non-employees using the fair value approach. Stock options and restricted stock awards to non-employees are subject to periodic revaluation over their vesting terms. Warrant Accounting As noted in Note 6, the Company classified a warrant to purchase shares of its common stock as a liability on its consolidated balance sheet if the warrant is a free-standing financial instrument that may require the Company to transfer consideration upon exercise. Each warrant of this type is initially recorded at fair value on date of grant using the Monte Carlo simulation model and net of issuance costs, and is subsequently re-measured to fair value at each subsequent balance sheet date. Changes in fair value of the warrant are recognized as a component of other income (expense), net in the consolidated statement of operations and comprehensive loss. The Company will continue to adjust the liability for changes in fair value until the earlier of the exercise or expiration of the warrant. Recent Accounting Pronouncements In March 2016, the Financial Accounting Standards Board (the “FASB”) issued Accounting Standards Update (“ASU”) No. 2016-09, Compensation-Stock Compensation (Topic 718): Improvements to Employee Shared-Based Payment Accounting. This standard provides guidance on accounting for employee share-based payments. This guidance addresses several aspects of the accounting for share-based payment award transactions, including: (a) income tax consequences; (b) classification of awards as either equity or liabilities; and (c) classification on the statement of cash flows. This standard will be effective for fiscal years beginning after December 15, 2016, including interim periods within those fiscal years. The Company is evaluating the impact of this guidance on the presentation of its results of operations, financial position and disclosures. In February 2016, the FASB, issued ASU, 2016-02- Leases (Topic 842) In November 2014, the FASB issued ASU 2014-16, Derivatives and Hedging (Topic 815): Determining Whether the Host Contract in a Hybrid Financial Instrument Issued in the Form of a Share Is More Akin to Debt or to Equity. This standard provides guidance to eliminate the existing diversity in practice in accounting for hybrid financial instruments issued in the form of a share. A hybrid financial instrument consists of a “host contract” into which one or more derivative terms have been embedded. This guidance requires an entity to consider the terms and features of the entire financial instrument, including the embedded derivative features, in order to determine whether the nature of the host contract is more akin to debt or to equity. This guidance is effective for fiscal years and interim periods beginning after December 15, 2015, with early adoption permitted. A reporting entity should apply this guidance using a modified retrospective approach by recording a cumulative-effect adjustment to equity as of the beginning of the annual period of adoption. Retrospective application is permitted to all relevant prior periods. The Company has concluded that this guidance has no impact on the presentation of its results of operations, financial position and disclosures. In August 2014, the FASB issued ASU No. 2014-15, Presentation of Financial Statements-Going Concern (Subtopic 205-40): Disclosure of Uncertainties about an Entity’s Ability to Continue as a Going Concern. This standard provides guidance that requires management to assess an entity’s ability to continue as a going concern every reporting period, and provide certain disclosures if management has substantial doubt about the entity’s ability to operate as a going concern, or an express statement if not, by incorporating and expanding upon certain principles that are currently in U.S. auditing standards. This guidance is effective for the annual period ending after December 15, 2016, and for annual periods and interim periods thereafter. Early application is permitted. The Company is evaluating the impact of this guidance on the presentation of its results of operations, financial position, and disclosures. In June 2014, the FASB issued ASU No. 2014-12, Compensation-Stock Compensation (Topic 718): Accounting for Share-Based Payments When the Terms of an Award Provide That a Performance Target Could be Achieved after the Requisite Service Period. This standard provides guidance requiring when there is a performance target that affects vesting of equity awards granted and could be achieved after the requisite service period to be treated as a performance condition. A reporting entity should apply existing guidance on stock-based compensation, as it relates to such awards. This guidance is effective for annual periods and interim periods within those annual periods beginning after December 15, 2015 with early adoption permitted using either of two methods: (i) prospective to all awards granted or modified after the effective date; or (ii) retrospective to all awards with performance targets that are outstanding as of the beginning of the earliest annual period presented in the financial statements and to all new or modified awards thereafter, with the cumulative effect of applying this guidance as an adjustment to the opening retained earnings balance as of the beginning of the earliest annual period presented in the financial statements. The Company issued performance-based awards during the year ended December 31, 2015. The Company adopted this guidance on a prospective basis and there have not been any performance-based awards since the effective date of the guidance. In May 2014, the FASB issued ASU No. 2014-09, Revenue from Contracts with Customers (Topic 606), which requires an entity to recognize the amount of revenue to which it expects to be entitled for the transfer of promised goods or services to customers. ASU 2014- 09 will replace most existing revenue recognition guidance in U.S. GAAP when it becomes effective. In July 2015, the FASB issued a one-year deferral of the effective date of the new revenue recognition standard. The new guidance will be effective for the Company’s first quarter of fiscal year 2018 and early application for fiscal year 2017 would be permitted. The Company’s adoption of this guidance is not expected to have a material impact on the consolidated financial statements. |
Loss Per Common Share
Loss Per Common Share | 9 Months Ended |
Sep. 30, 2016 | |
Earnings Per Share [Abstract] | |
Loss Per Common Share | 3. LOSS PER COMMON SHARE The Company computes basic and diluted loss per share using a methodology that gives effect to the impact of outstanding participating securities (the “two-class method”). As the three and nine month periods ended September 30, 2016 and 2015 resulted in net losses, there is no income allocation required under the two-class method or dilution attributed to the weighted-average shares outstanding in the calculation of diluted loss per share. Three Months Ended September 30, Nine Months Ended September 30, 2016 2015 2016 2015 Numerator: Net loss $ (9,315 ) $ (8,078 ) $ (25,271 ) $ (23,675 ) Net Loss attributable to Series A Preferred Stock (81 ) — (74 ) — Earnings (loss) attributable to common stockholders—basic and diluted $ (9,234 ) $ (8,078 ) $ (25,197 ) $ (23,675 ) Denominator: Weighted-average number of common shares used in earnings (loss) per share—basic and diluted 13,297,546 13,238,997 13,279,833 13,218,765 Earnings (loss) per share—basic and diluted $ (0.70 ) $ (0.61 ) $ (1.90 ) $ (1.79 ) The following potentially dilutive securities have been excluded from the computation of diluted weighted-average shares outstanding, as they would be anti-dilutive (in common stock equivalent shares): Three Months Ended Nine Months Ended September 30, 2016 2015 2016 2015 Unvested restricted stock and options to purchase common stock 882,887 1,233,494 882,887 1,233,494 Warrants exercisable into common stock 13,633,070 170,102 13,633,070 170,102 |
Property and Equipment
Property and Equipment | 9 Months Ended |
Sep. 30, 2016 | |
Property, Plant and Equipment [Abstract] | |
Property and Equipment | 4. PROPERTY AND EQUIPMENT Property and equipment consisted of the following: September 30, December 31, 2016 2015 Office equipment $ 539 $ 539 Laboratory equipment 4,442 4,337 Leasehold improvements 7,683 7,683 Construction in progress 759 547 Software 96 96 Total property and equipment 13,519 13,202 Less: accumulated depreciation (9,256 ) (7,989 ) Property and equipment, net $ 4,263 $ 5,213 Depreciation expense related to property and equipment amounted to $404 and $414 for the three months ended September 30, 2016 and 2015, respectively, and $1,267 and $1,182 for the nine months ended September 30, 2016 and 2015, respectively. |
Commitments and Contingencies
Commitments and Contingencies | 9 Months Ended |
Sep. 30, 2016 | |
Commitments and Contingencies Disclosure [Abstract] | |
Commitments and Contingencies | 5. COMMITMENTS AND CONTINGENCIES Operating Leases The Company leases its office and research facilities in Waltham and Lexington, Massachusetts under non-cancellable operating leases that expire at various dates through year 2023. Terms of the agreements generally provide for an initial rent-free period and future rent escalation, and provide that in addition to minimum lease rental payments, the Company is responsible for a pro-rata share of common area operating expenses. The Company’s wholly-owned subsidiary, ProChon, also leased a facility in Woburn, Massachusetts which expired during the second quarter of 2016. The Company did not renew the lease. Rent expense under operating lease agreements amounted to approximately $248 and $266 for the three months ended September 30, 2016 and 2015, respectively, and $742 and $857 for the nine months ended September 30, 2016 and 2015, respectively. As an inducement to enter into its Waltham and Lexington facility leases, the lessors agreed to provide the Company with construction allowances of up to $3,184 and $996, respectively towards the total cost of tenant improvements. The Company has recorded these costs in the condensed consolidated balance sheet as leasehold improvements, with the corresponding liability as deferred lease incentive. The liability is amortized on a straight-line basis over the term of the leases as a reduction of rent expense. License Agreements From time to time, the Company enters into various licensing agreements whereby the Company may use certain technologies in conjunction with its product research and development. Licensing agreements and the Company’s commitments under the agreements are as follows: Hydrogel License In May 2005, the Company entered into an exclusive license agreement with Angiotech Pharmaceuticals (US), Inc. for the use of certain patents, patent application, and knowledge related to the manufacture and use of a hydrogel material in conjunction with NeoCart and certain other products (“Hydrogel License Agreement”). As of September 30, 2016, the Company has paid an aggregate $3,200 in commercialization milestones under the terms of the Hydrogel License Agreement, which have been expensed to research and development. Under the terms of the Hydrogel License Agreement, the Company’s future commitments include: • A one-time $3,000 payment upon approval of an eligible product by the FDA; and • Single digit royalties on the net sales of NeoCart and certain other future products. Tissue Regeneration License In April 2001, the Company entered into an exclusive license agreement with The Board of Trustees of the Leland Stanford Junior University (“Stanford University”) for the use of certain technology to develop, manufacture and sell licensed products in the field of growth and regeneration of cartilage (“Tissue Regeneration License Agreement”). The term of the Tissue Regeneration License Agreement extends to the expiration date of Stanford University’s last to expire domestic or foreign patents. As of September 30, 2016, the Company has paid an aggregate $722 in patent reimbursement costs, royalty fees, and commercialization milestone payments under the terms of the Tissue Regeneration License Agreement, which have been recorded to research and development expense. Under the terms of the Tissue Regeneration License Agreement, the Company’s future commitments include: • A one-time $300 payment upon approval of an eligible product by the FDA; • An annual minimum non-refundable royalty fee of $10 for the life of the license that may be used to offset up to 50% of each earned royalty described below; and • Low single digit royalties on net sales. Honeycomb License In March 2013, the Company entered into a license agreement with Koken Co., Ltd. (“Koken”) and paid a fee for a non-exclusive, non-transferable and non-sublicensable right to use its know-how related to the process for manufacturing atelocollagen honeycomb sponge materials, which is used in scaffolds (the “Honeycomb License Agreement”). Under the terms of the Honeycomb License Agreement, future commitments will be based on the amount of materials supplied to the Company and may vary from period to period over the term of the agreement. Plasmid License In January 2008, the Company entered into an exclusive license agreement with Yeda Research and Development Co., Ltd. (“Yeda”) for rights relating to high level expression of heterologous proteins and plasmid p80 BS (the “Plasmid License Agreement”), which rights are jointly owned by Yeda and the Company. Under the terms of the Plasmid License Agreement, the Company was granted an exclusive worldwide license to manufacture, use and sell heterologous proteins and plasmid p80 BS. The Company is required to pay Yeda a yearly, non-refundable license fee of $2, which is creditable against royalties payable by the Company to Yeda during the one-year period in which such fee was paid. Yeda is also entitled to low single digit royalties on net sales of the licensed products and on net sales for combination products (meaning the combination of the licensed product with at least one other active ingredient, material or medical device that would have a clinical effect if administered independently) and a low double digit percentage of all of the Company’s sublicensing receipts. Tissue Processor Sub-License In December 2005, the Company entered into an exclusive agreement to sub-license certain technology from Purpose, Co. (“Purpose”), which is owned by a stockholder of the Company (“Sub-License Agreement”). Purpose entered into the original license agreement (“Original Agreement”) with Brigham and Women’s Hospital, Inc. (“Brigham and Women’s”) in August 2001. The Original Agreement shall remain in effect for the licensed patents owned by Brigham and Women’s unless extended or terminated as provided for in the agreement. The technology is to be used to develop, manufacture, use and sell licensed products that cultivate cell or tissue development. The Sub-License Agreement extends to the expiration date of the last to expire domestic or foreign patents covered by the agreement. As of September 30, 2016, the Company has paid an aggregate $991 in royalty and sub-license payments under the terms of the Sub-License Agreement. The Sub-License Agreement was amended and restated in June 2012. Under the amended and restated agreement, the Company made Purpose the sole supplier of equipment the Company uses in its manufacturing processes, and granted Purpose distribution rights of the Company’s products for certain territories. In exchange, Purpose allowed for the use of its technology (owned or licensed) and manufactured and serviced exogenous tissue processors used by the Company. Under the terms of the agreement, as amended, Purpose granted the Company: (a) exclusive rights to all of Purpose’s technology (owned or licensed) related to the exogenous tissue processors, (b) continued supply of exogenous tissue processors during the Company’s clinical trials, and (c) rights to manufacture the exogenous tissue processors at any location the Company chooses. In exchange for such consideration, the Company granted Purpose an exclusive license in Japan for the use of all of the Company’s technology and made a payment of $250 to reimburse Purpose for development costs on a next generation tissue processor. In May 2016, the Original Agreement was amended whereby the Company acquired the development and commercialization rights to NeoCart for the Japanese market from Purpose. Under the terms of the amended agreement, the Company assumes sole responsibility for and rights to the development and commercialization of NeoCart in Japan. In exchange for the transfer of development and commercialization rights, the Company will pay a success-based milestone to Purpose upon conditional approval of NeoCart in Japan, as well as commercial milestones and a low single digit royalty on Japanese sales of NeoCart, upon full approval, if any, in Japan In addition to the above, the Company’s future commitments under the terms of the Original Agreement and Sub-License Agreement include: • A minimum non-refundable annual royalty fee of $20, for the life of the license; • An additional, non-refundable annual royalty fee of $30 from 2016 through 2019; • $10,200 in potential milestone payments; and • Low single digit royalties on net sales of a licensed product. The OCS Agreement In connection with its research and development, the Company received grants from the Office of Chief Scientist of the Ministry of Industry and Trade in Israel (“OCS”) in the aggregate of $1,100 for funding the fibroblast growth factor (“FGF”) program. In consideration for this grant, the Company is committed to pay royalties at a rate of 3% to 5% of the sales of sponsored products developed using the grant money, up to the amount of the participation payments received. The Company committed to pay up to 100% of grants received plus interest according to the LIBOR interest rate if the sponsored product is produced in Israel. If the manufacturing of the sponsored product takes place outside of Israel, the royalties can increase up to, but no more than, 300% of grants received plus interest based on the LIBOR interest rate, depending on the percentage of the manufacturing of sponsored product that takes place outside of Israel. Engineering Agreement The Company entered into an agreement with a development corporation to purchase a multi-unit bioreactor system. Pursuant to the agreement, as of September 30, 2016, the Company made total payments in an aggregate amount of $567, of which $190 was made in the second quarter of 2016 after acceptance of the final product. There are no additional payments due under this agreement. Collagen Supply Agreement In September 2015, the Company entered into an agreement with Collagen Solutions (UK) Limited (the “Supplier”) to purchase soluble collagen that meets specifications provided by the Company. The initial term of the agreement is three years and will automatically renew from year to year thereafter unless otherwise terminated with at least 180 days’ notice by either party. Pursuant to the agreement, starting 12 months after entering into the agreement, the Company will be required to order a minimum amount of material and/or services totaling $150 from the Supplier in each calendar year until the expiration of the initial term of the agreement. The Company also committed to pay a non-refundable payment totaling $123 by the end of 2015. This expense was recorded to research and development expense as of December 31, 2015. As of September 30, 2016, the Company has paid $93 under the terms of the agreement. The remaining amount of $30 is expected to be paid in the fourth quarter of 2016. |
Capital Stock
Capital Stock | 9 Months Ended |
Sep. 30, 2016 | |
Equity [Abstract] | |
Capital Stock | 6. CAPITAL STOCK On September 29, 2016, the Company closed the private placement contemplated by the securities purchase agreement (the “Purchase Agreement”), dated September 15, 2016, between the Company and certain institutional and accredited investors in which the Company received gross proceeds of $30.0 million (the “Private Placement”). At the closing, the Company issued 2,596,059 shares of the Company’s common stock at a per share price of $2.25 and 24,158.8693 shares of the Company’s newly-created Series A Convertible Preferred Stock (“Series A Preferred Stock”), which are convertible into approximately 10,737,275 shares of common stock. As part of the Private Placement, the investors received warrants to purchase up to 13,333,334 shares of the Company’s common stock at an exercise price of $2.25 per share. The placement agent for the Private Placement, H.C. Wainwright & Co. LLC (“HCW”), and certain of its affiliates were also granted warrants to purchase 133,333 shares of the Company’s common stock in exchange for the services provided by HCW. The placement agent warrants were considered a financing cost of the Company and included in warrant expense within the condensed consolidated statements of operations. The warrants include a cashless-exercise feature that may be exercised solely in the event there is no effective registration statement , or no current prospectus available for, the resale of the shares of common stock underlying the warrants as of the six-month anniversary of the closing of the Private Placement. Upon a fundamental transaction, the holders of the warrant may require the Company to purchase any unexercised warrants in an amount equal to the Black-Scholes value of the option. A fundamental transaction is defined as a merger, sale of assets, sale of the Company, recapitalization of stock and a sale of stock whereby any owner after the transaction would own greater than 50% of the outstanding common stock in the Company. The warrants will be exercisable following approval of the Private Placement by our stockholders and expire five years after the date of such stockholder approval. The Company determined the warrants are classified as a liability on the Balance Sheet because they contain a provision whereby in a fundamental transaction (as described above), the holder can elect to receive either the amount they are entitled to on an as-if-exercised basis or an amount based on the Black-Scholes value of the warrants at the time of the fundamental transaction. At the issuance date, the warrants were recorded at the fair value of $30,400 and approximately $400 excess of the fair value of the liability recorded for these warrants over the proceeds received was recorded as a charge to earnings in the third quarter of 2016 and is included in warrant expense within the condensed consolidated statement of operations. In connection with the Private Placement, the Company incurred expenses of $2,326 included in warrant expense within the condensed consolidated statements of operations. Concurrent with the closing of the Private Placement, the Company’s Certificate of Incorporation was amended by the filing of a Certificate of Designation to create the Series A Preferred Stock. The Series A Preferred Stock has a par value of $0.01 and each share is convertible into 444.44 shares of common stock, at a conversion price of $2.25 per share, at the option of the holder. The Series A Preferred Stock has no voting rights and is only entitled to dividends as declared on an as-converted basis. The Series A Preferred Stock contains no liquidation preferences or redemption rights and shares in distributions of the Company on an as-converted basis with the common stock. As part of the Private Placement, affiliates of certain members of the Company’s Board of Directors purchased an aggregate of 283,046 shares of common stock, an aggregate of 2,563.1439 shares of Series A Preferred Stock and received warrants to purchase up to 1,422,221 shares of common stock at an exercise price of $2.25 per share in the Private Placement. These amounts are included in the amounts noted above. |
Warrants
Warrants | 9 Months Ended |
Sep. 30, 2016 | |
Text Block [Abstract] | |
Warrants | 7. WARRANTS Investor Warrants In September 2016, in connection with the Private Placement, the Company issued common stock warrants to the investors to purchase up to 13,333,334 shares of our common stock at an exercise price of $2.25 per share. The warrants include a cashless-exercise feature that may be exercised solely in the event there is no effective registration statement registering, or no current prospectus available for, the resale of the shares of common stock underlying the warrants as of the six-month anniversary of the closing of the Private Placement. The warrants will be exercisable following approval of the Private Placement by our stockholders and expire five years after the date of such stockholder approval. The warrants were valued at $2.28 using a Monte Carlo simulation and are marked-to-market on a quarterly basis with the change in value recorded as warrant expense or income on the condensed consolidated statements of operations. Placement Agent Warrants In September 2016, in connection with the Private Placement, the Company issued HCW and certain of its affiliates warrants for the purchase of 133,333 shares of common stock at an exercise price of $2.25 per share. The HCW warrants will become exercisable following approval of the Private Placement by our stockholders and expire five years after the date on which such stockholder approval is obtained. The warrants were valued using a Monte Carlo simulation and is marked-to-market on a quarterly basis with the change in value recorded as warrant expense or income on the condensed consolidated statements of operations. Consulting Agreement Warrant In March 2015, in connection with a consulting agreement entered into for an interim chief financial officer, the Company issued a common stock warrant as compensation to the consulting firm. The warrant provides the holder with the right to purchase an aggregate of 7,398 shares of the Company’s common stock at a per share exercise price of $9.75, the closing price of the Company’s common stock on the date of issuance. The warrant vests and becomes exercisable in monthly installments over 24 months beginning September 30, 2015 and expires on the tenth anniversary of issuance. The warrant is equity classified and accounted for using the fair value approach. The fair value of the warrant is estimated using the Black-Scholes option pricing model and is subject to re-measurement at each reporting period until the measurement date is reached. On December 21, 2015, the Company terminated the consulting agreement resulting in the forfeiture of 50% (3,699) of the shares eligible for exercise under the warrant. The remaining 3,699 shares were vested and exercisable on December 31, 2015 and September 30, 2016. The related warrant expense is included in general and administrative expenses on a straight-line basis over the expected service period, which is the vesting period. Affiliates of an Advisor Warrant In connection with the issuance of the Series A Preferred Stock on July 20, 2012, the Company issued a warrant to purchase its common stock to affiliates of an advisor. The warrant provides the holders with the right to purchase an aggregate of 161,977 shares of the Company’s common stock at a per share exercise price of $0.01. The warrants are exercisable, in whole or in part, immediately and may be exercised on a cashless basis. The warrants expire on the tenth anniversary of issuance. The fair value of the warrants of $117 was estimated using the Black-Scholes option pricing model and was recorded as a reduction to Series A Preferred Stock and a credit to additional paid-in capital. On December 8, 2014, the Company completed its initial public offering and warrants for 5,839 shares of common stock were surrendered to partially settle a related liability and common stock was issued by the Company to Purpose for the warrant shares surrendered. As of September 30, 2016, and December 31, 2015, warrants to purchase an aggregate of 156,138 shares of the Company’s common stock at an exercise price of $0.01 are outstanding. Equipment Line of Credit Warrant In July 2014, the Company granted Silicon Valley Bank a warrant to purchase 6,566 shares of common stock at a per share exercise price of $7.99 as discussed in Note 10. The warrant is exercisable, in whole or in part, immediately and may be exercised on a cashless basis and expires on the tenth anniversary of issuance. The fair value of the warrant as of July 9, 2014 was estimated at $51 with the following inputs: (a) risk-free interest rate of 2.58%; (b) implied volatility of the Company’s common stock of 87%; (c) the expected term of 10 years. The fair value of the warrant was recorded as a debt issuance cost with a corresponding credit to additional paid-in capital. |
Stock-Based Compensation
Stock-Based Compensation | 9 Months Ended |
Sep. 30, 2016 | |
Disclosure of Compensation Related Costs, Share-based Payments [Abstract] | |
Stock-Based Compensation | 8. STOCK-BASED COMPENSATION Stock option activity under the Company’s 2012 Equity Incentive Plan (the “2012 Plan”) and 2013 Equity Incentive Plan (the “2013 Plan”) for the nine months ended September 30, 2016 is summarized as follows: Number of Options Weighted- Average Exercise Price Weighted- Average Remaining Contractual Term (in years) Aggregate Intrinsic Value (in thousands) Outstanding at December 31, 2015 1,229,339 $ 7.32 Granted 214,840 2.51 Exercised (3,685 ) 0.76 Cancelled (111,430 ) 4.92 Outstanding at September 30, 2016 1,329,064 $ 6.77 8.4 $ 266 Vested and expected to vest at September 30, 2016 1,248,103 $ 6.78 8.4 $ 253 Exercisable at September 30, 2016 449,478 $ 7.05 7.9 $ 130 As of September 30, 2016, the unrecognized compensation cost related to outstanding options was $2,744 and is expected to be recognized as expense over approximately 2.13 years. As of September 30, 2016, the weighted average grant date fair value of vested options was $4.96 and the weighted average grant date fair value of shares outstanding was $4.15. The weighted average grant date fair value per share of employee option grants was $2.47 and $3.22 for the three months ended September 30, 2016 and 2015, respectively, and $1.40 and $4.55 for the nine months ended September 30, 2016 and 2015, respectively. Restricted stock awards under the 2012 Plan and 2013 Plan for the three months ended September 30, 2016 are summarized as follows: Number of Shares Weighted Average Grant Date Fair Value Unvested at December 31, 2015 5,190 $ 1.07 Vesting of restricted stock (1,889 ) Unvested at September 30, 2016 3,301 $ 0.71 As of September 30, 2016, the unrecognized compensation cost related to restricted stock awards was $1 and is expected to be recognized as expense over approximately 0.52 years. Stock-Based Compensation Expense The Company granted stock options to employees during the three and nine months ended September 30, 2016 and 2015. The Company estimates the fair value of stock options as of the date of grant using the Black-Scholes option pricing model and restricted stock based on the stock price, with the exception of those stock options that included a market condition. The Company estimates the fair value of stock options that include a market condition using a Monte-Carlo model. Stock options and restricted stock issued to non-board member, non-employees are accounted for using the fair value approach and are subject to periodic revaluation over their vesting terms. Stock-based compensation expense amounted to $435 and $362 for the three months ended September 30, 2016 and 2015, respectively, and $1,080 and $854 for the nine months ended September 30, 2016 and 2015, respectively. The allocation of stock-based compensation for all options granted and restricted stock awards is as follows: Three Months Ended September 30, Nine Months Ended September 30, 2016 2015 2016 2015 Research and development $ 126 $ 126 $ 364 $ 319 General and administrative 309 236 716 535 Total stock-based compensation expense $ 435 $ 362 $ 1,080 $ 854 Stock-based compensation by award type is as follows: Three Months Ended September 30, Nine Months Ended September 30, 2016 2015 2016 2015 Stock options $ 434 $ 361 $ 1,078 $ 851 Restricted stock 1 1 2 3 Total stock-based compensation expense $ 435 $ 362 $ 1,080 $ 854 The weighted-average assumptions used in the Black-Scholes option pricing model to determine the fair value of the employee stock option grants were as follows: Three Months Ended Nine Months Ended September 30, 2016 2015 2016 2015 Risk-free interest rate 1.36 % 1.73 % 1.39 % 1.67 % Expected volatility 85.2 % 60.1 % 59.7 % 62.8 % Expected term (in years) 6.08 6.08 6.08 6.04 Expected dividend yield 0.0 % 0.0 % 0.0 % 0.0 % The weighted-average assumptions used in the Black-Scholes option pricing model to determine the fair value of the non-employee stock option grants were as follows: Three Months Ended September 30, Nine Months Ended September 30, 2016 2015 2016 2015 Risk-free interest rate 1.53 % 1.79 % 1.59 % 1.66 % Expected volatility 63.2 % 60.8 % 63.6 % 63.3 % Expected term (in years) 6.97 7.48 7.00 5.81 Expected dividend yield 0.0 % 0.0 % 0.0 % 0.0 % |
Income Taxes
Income Taxes | 9 Months Ended |
Sep. 30, 2016 | |
Income Tax Disclosure [Abstract] | |
Income Taxes | 9. INCOME TAXES Deferred tax assets and deferred tax liabilities are recognized based on temporary differences between the financial reporting and tax basis of assets and liabilities using statutory rates. A valuation allowance is recorded against deferred tax assets if it is more likely than not that some or all of the deferred tax assets will not be realized. Due to the uncertainty surrounding the realization of the favorable tax attributes in future tax returns, the Company has recorded a full valuation allowance against the Company’s otherwise recognizable net deferred tax assets. |
Equipment Loan Payable
Equipment Loan Payable | 9 Months Ended |
Sep. 30, 2016 | |
Debt Disclosure [Abstract] | |
Equipment Loan Payable | 10. EQUIPMENT LOAN PAYABLE As of September 30, 2016 and December 31, 2015, the Company had the following outstanding borrowing obligations (in thousands): September 30, December 31, 2016 2015 Silicon Valley Bank Equipment Loan Payable $ 907 $ 1,344 Less: current portion (583 ) (583 ) Long-term debt, net $ 324 $ 761 In July 2014, the Company entered into a loan and security agreement with Silicon Valley Bank, which provides for a line of credit to finance certain equipment purchases up to an aggregate of $1,750 million through March 31, 2015. The line has been fully drawn and is payable in 36 monthly installments of principal and interest, with an annual interest rate of 2.75% plus the greater of 3.25% and the prime rate in effect at the time of each draw, as published in the Wall Street Journal. The outstanding balance on the line of credit is secured by a first priority lien over all equipment purchased using the line of credit. In accordance with the terms of the equipment line of credit, the Company issued a warrant to Silicon Valley Bank in July 2014 to purchase 6,566 shares of our common stock at an exercise price per share of $7.99 as discussed in Note 7. The equipment line of credit includes customary operating but non-financial covenants, including limitations on the Company’s ability to incur additional indebtedness, issue dividends, sell assets, engage in any business other than its current business, merge or consolidate with other entities, create liens on our assets, make investments, repurchase stock in certain instances, enter into transactions with affiliates, make payments on subordinated indebtedness and transfer or encumber any collateral securing the debt. As of September 30, 2016 and December 31, 2015, $900 and $1,340, respectively, of borrowings were outstanding under the line of credit and the Company was in compliance with all required covenants. The scheduled maturities of the Company’s long-term debt are as follows (in thousands): September 30, 2016 December 31, 2015 December 31, 2016 $ 146 $ 583 December 31, 2017 583 583 December 31, 2018 178 178 $ 907 $ 1,344 |
Related Parties
Related Parties | 9 Months Ended |
Sep. 30, 2016 | |
Related Party Transactions [Abstract] | |
Related Parties | 11. RELATED PARTIES Intrexon Corporation In September 2014, the Company entered into an Exclusive Channel Collaboration agreement with Intrexon (the “Collaboration Agreement”) to use Intrexon’s proprietary technology for the development and commercialization of allogeneic cell therapeutics (the “Collaboration Products”) to treat or repair damaged articular hyaline cartilage in humans. The term of the Collaboration Agreement commenced upon the effective date, September 30, 2014, and continues until either written notice of termination is given by the Company within ninety days, or if either party creates a material breach that cannot be remedied within sixty days. Under the terms of the Collaboration Agreement, the Company is solely responsible for the costs to develop and commercialize any Collaboration Products with the following exceptions: (i) the establishment of certain manufacturing capabilities and facilities; (ii) the cost of basic research related to Intrexon’s proprietary technology outside of costs related to the Collaboration Products; (iii) payments related to certain in-licensed third party IP; (iv) the costs of filing, prosecution and maintenance of Intrexon patents; and (v) any other costs mutually agreed upon as being the responsibility of Intrexon. As partial consideration, the Company will pay commercialization milestones totaling $12,000, if and when achieved, and sales milestones totaling $22,500, if and when achieved. The milestone payments are payable in cash or shares of the Company’s common stock at the option of the Company. In the event the Company is sold prior to making any of these milestone payments and the Collaboration Agreement is transferred in the sale, the milestone payments would be payable in cash. The Company is also required to make low double digit royalty payments to Intrexon on any gross profit arising from the sale of Collaboration Products and to pay an intermediate double digit percentage of any sublicensing revenue it receives. Under the terms of the Collaboration Agreement, the Company reimburses Intrexon for 50% of the product research and development costs with the remaining 50% due after acceptance by the FDA or equivalent regulatory authority of an Investigational New Drug Application or equivalent regulatory filing of a collaboration product. Total incurred expenses were $2,272 and $2,311 for the nine months ended September 30, 2016 and 2015. The total accrued expenses due Intrexon at September 30, 2016 and December 31, 2015 was $2,802 and $1,546 respectively. Amounts are reflected as current liabilities in the condensed consolidated balance sheets. Board of Director Affiliates. Affiliates of certain members of the Company’s Board of Directors participated in the Private Placement as described in Note 6. |
Summary of Significant Accoun18
Summary of Significant Accounting Policies (Policies) | 9 Months Ended |
Sep. 30, 2016 | |
Accounting Policies [Abstract] | |
Reclassifications | Reclassifications The Company has reclassified certain prior period amounts to conform to the current period presentation. The amounts reclassified impact Accounts Payable and Accrued Expenses and Accounts Payable due to Intrexon Corporation (“Intrexon”) and Accrued Expenses due to Intrexon for the nine months ended September 30, 2015 and the year ended December 31, 2015. |
Segment and Geographic Information | Segment and Geographic Information Information about the Company’s operations in different geographic regions is presented in the tables below: September 30, December 31, Long-lived assets: United States $ 4,257 $ 5,204 Israel 6 9 Total long-lived assets $ 4,263 $ 5,213 |
Fair Value Measurements | Fair Value Measurements The carrying amounts reported in the Company’s condensed consolidated financial statements for cash and cash equivalents, accounts payable and accrued liabilities approximate their respective fair values because of the short-term nature of these accounts. As a basis for determining the fair value of certain of the Company’s financial instruments, the Company utilizes a three-tier value hierarchy, which prioritizes the inputs used in measuring fair value as follows: Level 1 Level 2 Level 3 The Company had no assets or liabilities classified as Level 1 or Level 2 as of September 30, 2016 and December 31, 2015, other than the money market fund described in the “Cash and Cash Equivalents” section below, and there were no material re-measurements of fair value with respect to financial assets and liabilities during the periods presented, other than those assets and liabilities that are measured at fair value on a recurring basis. Other than the warrants issued in connection with the private placement transaction which closed on September 29, 2016, the Company had no assets or liabilities classified as Level 3 as of September 30, 2016. There were no assets or liabilities classified as Level 3 as of December 31, 2015. Transfers are calculated on values as of the transfer date. There were no transfers between Levels 1, 2 and 3 during the nine months ended September 30, 2016 and 2015. |
Cash and Cash Equivalents | Cash and Cash Equivalents The Company considers all highly liquid securities with original maturities of three months or less from the date of purchase to be cash equivalents. As of September 30, 2016, cash and cash equivalents comprise cash deposits of $30,204 and money market funds of $7,790. The money market funds are measured at fair value on a recurring basis based on quoted market prices. |
Intangible Asset | Intangible Asset As of September 30, 2016 and December 31, 2015, the Company’s intangible asset consists of acquired in-process research and development (“IPR&D”). For the nine months ended September 30, 2016 and 2015, the Company determined that there were no triggering events indicating impairment of its IPR&D. Intangible assets, net of accumulated impairment charges, are summarized as follows: As of September 30, 2016 As of December 31, 2015 Cost Accumulated Impairment Net Book Value Cost Accumulated Impairment Net Book Value IPR&D $ 630 $ (430 ) $ 200 $ 630 $ (430 ) $ 200 $ 630 $ (430 ) $ 200 $ 630 $ (430 ) $ 200 |
Stock-Based Compensation | Stock-Based Compensation The Company accounts for stock options and restricted stock based on their grant date fair value and recognizes compensation expense on a straight-line basis over their vesting period. The Company estimates the fair value of stock options as of the date of grant using the Black-Scholes option pricing model, with the exception of stock options that include a market condition, and of restricted stock based on the fair value of the underlying common stock as of the date of grant or the value of the services provided, whichever is more readily determinable. The Company is also required to estimate forfeitures at the time of grant, and revise those estimates in subsequent periods if actual forfeitures differ from its estimates. The Company uses historical data to estimate pre-vesting option forfeitures and records stock-based compensation expense only for those awards that are expected to vest. 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 revised. Stock-based compensation expense is classified as research and development or general and administrative based on the grantee’s respective compensation classification. For stock option grants with vesting triggered by the achievement of performance-based milestones, the expense is recorded over the remaining service period after the point when the achievement of the milestone is probable or the performance condition has been achieved. For stock option grants with both performance-based milestones and market conditions, expense is recorded over the derived service period after the point when the achievement of the performance-based milestone is probable or the performance condition has been achieved. For stock option grants with market conditions, the expense is calculated using the Monte Carlo model based on the grant date fair value of the option and is recorded on a straight line basis over the requisite service period, which represents the derived service period and accelerated when the market condition is satisfied. The Company did not issue awards with market conditions during the three and nine months ended September 30, 2016. The Company accounts for stock options and restricted stock awards to non-employees using the fair value approach. Stock options and restricted stock awards to non-employees are subject to periodic revaluation over their vesting terms. |
Recent Accounting Pronouncements | Recent Accounting Pronouncements In March 2016, the Financial Accounting Standards Board (the “FASB”) issued Accounting Standards Update (“ASU”) No. 2016-09, Compensation-Stock Compensation (Topic 718): Improvements to Employee Shared-Based Payment Accounting. This standard provides guidance on accounting for employee share-based payments. This guidance addresses several aspects of the accounting for share-based payment award transactions, including: (a) income tax consequences; (b) classification of awards as either equity or liabilities; and (c) classification on the statement of cash flows. This standard will be effective for fiscal years beginning after December 15, 2016, including interim periods within those fiscal years. The Company is evaluating the impact of this guidance on the presentation of its results of operations, financial position and disclosures. In February 2016, the FASB, issued ASU, 2016-02- Leases (Topic 842) In November 2014, the FASB issued ASU 2014-16, Derivatives and Hedging (Topic 815): Determining Whether the Host Contract in a Hybrid Financial Instrument Issued in the Form of a Share Is More Akin to Debt or to Equity. This standard provides guidance to eliminate the existing diversity in practice in accounting for hybrid financial instruments issued in the form of a share. A hybrid financial instrument consists of a “host contract” into which one or more derivative terms have been embedded. This guidance requires an entity to consider the terms and features of the entire financial instrument, including the embedded derivative features, in order to determine whether the nature of the host contract is more akin to debt or to equity. This guidance is effective for fiscal years and interim periods beginning after December 15, 2015, with early adoption permitted. A reporting entity should apply this guidance using a modified retrospective approach by recording a cumulative-effect adjustment to equity as of the beginning of the annual period of adoption. Retrospective application is permitted to all relevant prior periods. The Company has concluded that this guidance has no impact on the presentation of its results of operations, financial position and disclosures. In August 2014, the FASB issued ASU No. 2014-15, Presentation of Financial Statements-Going Concern (Subtopic 205-40): Disclosure of Uncertainties about an Entity’s Ability to Continue as a Going Concern. This standard provides guidance that requires management to assess an entity’s ability to continue as a going concern every reporting period, and provide certain disclosures if management has substantial doubt about the entity’s ability to operate as a going concern, or an express statement if not, by incorporating and expanding upon certain principles that are currently in U.S. auditing standards. This guidance is effective for the annual period ending after December 15, 2016, and for annual periods and interim periods thereafter. Early application is permitted. The Company is evaluating the impact of this guidance on the presentation of its results of operations, financial position, and disclosures. In June 2014, the FASB issued ASU No. 2014-12, Compensation-Stock Compensation (Topic 718): Accounting for Share-Based Payments When the Terms of an Award Provide That a Performance Target Could be Achieved after the Requisite Service Period. This standard provides guidance requiring when there is a performance target that affects vesting of equity awards granted and could be achieved after the requisite service period to be treated as a performance condition. A reporting entity should apply existing guidance on stock-based compensation, as it relates to such awards. This guidance is effective for annual periods and interim periods within those annual periods beginning after December 15, 2015 with early adoption permitted using either of two methods: (i) prospective to all awards granted or modified after the effective date; or (ii) retrospective to all awards with performance targets that are outstanding as of the beginning of the earliest annual period presented in the financial statements and to all new or modified awards thereafter, with the cumulative effect of applying this guidance as an adjustment to the opening retained earnings balance as of the beginning of the earliest annual period presented in the financial statements. The Company issued performance-based awards during the year ended December 31, 2015. The Company adopted this guidance on a prospective basis and there have not been any performance-based awards since the effective date of the guidance. In May 2014, the FASB issued ASU No. 2014-09, Revenue from Contracts with Customers (Topic 606), which requires an entity to recognize the amount of revenue to which it expects to be entitled for the transfer of promised goods or services to customers. ASU 2014- 09 will replace most existing revenue recognition guidance in U.S. GAAP when it becomes effective. In July 2015, the FASB issued a one-year deferral of the effective date of the new revenue recognition standard. The new guidance will be effective for the Company’s first quarter of fiscal year 2018 and early application for fiscal year 2017 would be permitted. The Company’s adoption of this guidance is not expected to have a material impact on the consolidated financial statements. |
Summary of Significant Accoun19
Summary of Significant Accounting Policies (Tables) | 9 Months Ended |
Sep. 30, 2016 | |
Accounting Policies [Abstract] | |
Summary of Operations in Different Geographic Regions | Information about the Company’s operations in different geographic regions is presented in the tables below: September 30, December 31, Long-lived assets: United States $ 4,257 $ 5,204 Israel 6 9 Total long-lived assets $ 4,263 $ 5,213 |
Schedule of Assets and Liabilities Measured at Fair Value on Recurring Basis | The fair value of the warrants was determined using a Monte Carlo simulation model. This model incorporated several assumptions at each valuation date including: the price of the Company’s common stock on the date of valuation, the historical volatility of the price of the Company’s common stock, the remaining contractual term of the warrant and estimates of the probability of a fundamental transaction occurring. (See Note 6 for further discussion of the private placement) This valuation is considered a Level 3 valuation. Description Total Quoted prices in active markets (Level 1) Significant other observable (Level 2) Significant unobservable inputs (Level 3) September 30, 2016 Assets: Money market funds $ 7,790 $ 7,790 $ — $ — Liabilities: Warrant liability $ 30,165 $ — $ — $ 30,165 December 31, 2015 Money market funds $ 25,764 $ 25,764 $ — $ — |
Schedule of Reconciliation of Liabilities Measured at Fair Value | The following table provides a reconciliation of all liabilities measured at fair value using Level 3 significant unobservable inputs: As of September 30, 2016 Beginning balance $ — Issuance of warrants, 30,704 Change in fair value of warrant liability (539 ) Ending balance $ 30,165 |
Summary of Intangible Assets, Net of Accumulated Impairment Charges | Intangible assets, net of accumulated impairment charges, are summarized as follows: As of September 30, 2016 As of December 31, 2015 Cost Accumulated Impairment Net Book Value Cost Accumulated Impairment Net Book Value IPR&D $ 630 $ (430 ) $ 200 $ 630 $ (430 ) $ 200 $ 630 $ (430 ) $ 200 $ 630 $ (430 ) $ 200 |
Loss Per Common Share (Tables)
Loss Per Common Share (Tables) | 9 Months Ended |
Sep. 30, 2016 | |
Earnings Per Share [Abstract] | |
Schedule of Basic and Diluted Loss Per Common Share | As the three and nine month periods ended September 30, 2016 and 2015 resulted in net losses, there is no income allocation required under the two-class method or dilution attributed to the weighted-average shares outstanding in the calculation of diluted loss per share. Three Months Ended Nine Months Ended 2016 2015 2016 2015 Numerator: Net loss $ (9,315 ) $ (8,078 ) $ (25,271 ) $ (23,675 ) Net Loss attributable to Series A Preferred Stock (81 ) — (74 ) — Earnings (loss) attributable to common stockholders—basic and diluted $ (9,234 ) $ (8,078 ) $ (25,197 ) $ (23,675 ) Denominator: Weighted-average number of common shares used in earnings (loss) per share—basic and diluted 13,297,546 13,238,997 13,279,833 13,218,765 Earnings (loss) per share—basic and diluted $ (0.70 ) $ (0.61 ) $ (1.90 ) $ (1.79 ) |
Schedule of Antidilutive Securities Excluded from Computation of Earnings Per Share | The following potentially dilutive securities have been excluded from the computation of diluted weighted-average shares outstanding, as they would be anti-dilutive (in common stock equivalent shares): Three Months Ended Nine Months Ended September 30, 2016 2015 2016 2015 Unvested restricted stock and options to purchase common stock 882,887 1,233,494 882,887 1,233,494 Warrants exercisable into common stock 13,633,070 170,102 13,633,070 170,102 |
Property and Equipment (Tables)
Property and Equipment (Tables) | 9 Months Ended |
Sep. 30, 2016 | |
Property, Plant and Equipment [Abstract] | |
Schedule of Property and Equipment | Property and equipment consisted of the following: September 30, December 31, 2016 2015 Office equipment $ 539 $ 539 Laboratory equipment 4,442 4,337 Leasehold improvements 7,683 7,683 Construction in progress 759 547 Software 96 96 Total property and equipment 13,519 13,202 Less: accumulated depreciation (9,256 ) (7,989 ) Property and equipment, net $ 4,263 $ 5,213 |
Stock-Based Compensation (Table
Stock-Based Compensation (Tables) | 9 Months Ended |
Sep. 30, 2016 | |
Disclosure of Compensation Related Costs, Share-based Payments [Abstract] | |
Summary of Stock Option Activity Under the 2012 and 2013 Plans | Stock option activity under the Company’s 2012 Equity Incentive Plan (the “2012 Plan”) and 2013 Equity Incentive Plan (the “2013 Plan”) for the nine months ended September 30, 2016 is summarized as follows: Number of Options Weighted- Average Exercise Price Weighted- Average Remaining Contractual Term (in years) Aggregate Intrinsic Value (in thousands) Outstanding at December 31, 2015 1,229,339 $ 7.32 Granted 214,840 2.51 Exercised (3,685 ) 0.76 Cancelled (111,430 ) 4.92 Outstanding at September 30, 2016 1,329,064 $ 6.77 8.4 $ 266 Vested and expected to vest at September 30, 2016 1,248,103 $ 6.78 8.4 $ 253 Exercisable at September 30, 2016 449,478 $ 7.05 7.9 $ 130 |
Schedule of Restricted Stock Awards Under the 2012 and 2013 Plans | Restricted stock awards under the 2012 Plan and 2013 Plan for the three months ended September 30, 2016 are summarized as follows: Number Weighted Average Grant Date Fair Value Unvested at December 31, 2015 5,190 $ 1.07 Vesting of restricted stock (1,889 ) Unvested at September 30, 2016 3,301 $ 0.71 |
Summary of Stock-Based Compensation for all Options Granted and Restricted Stock Awards | The allocation of stock-based compensation for all options granted and restricted stock awards is as follows: Three Months Ended September 30, Nine Months Ended September 30, 2016 2015 2016 2015 Research and development $ 126 $ 126 $ 364 $ 319 General and administrative 309 236 716 535 Total stock-based compensation expense $ 435 $ 362 $ 1,080 $ 854 |
Summary of Stock-Based Compensation by Award | Stock-based compensation by award type is as follows: Three Months Nine Months 2016 2015 2016 2015 Stock options $ 434 $ 361 $ 1,078 $ 851 Restricted stock 1 1 2 3 Total stock-based compensation expense $ 435 $ 362 $ 1,080 $ 854 |
Summary of Weighted-Average Assumptions Used in the Black-Scholes Option Pricing Model to Determine the Fair Value of the Employee Stock Option Grants | The weighted-average assumptions used in the Black-Scholes option pricing model to determine the fair value of the employee stock option grants were as follows: Three Months Ended Nine Months Ended September 30, 2016 2015 2016 2015 Risk-free interest rate 1.36 % 1.73 % 1.39 % 1.67 % Expected volatility 85.2 % 60.1 % 59.7 % 62.8 % Expected term (in years) 6.08 6.08 6.08 6.04 Expected dividend yield 0.0 % 0.0 % 0.0 % 0.0 % |
Summary of Weighted-Average Assumptions Used in the Black-Scholes Option Pricing Model to Determine the Fair Value of the Non-Employee Stock Option Grants | The weighted-average assumptions used in the Black-Scholes option pricing model to determine the fair value of the non-employee stock option grants were as follows: Three Months Nine Months 2016 2015 2016 2015 Risk-free interest rate 1.53 % 1.79 % 1.59 % 1.66 % Expected volatility 63.2 % 60.8 % 63.6 % 63.3 % Expected term (in years) 6.97 7.48 7.00 5.81 Expected dividend yield 0.0 % 0.0 % 0.0 % 0.0 % |
Equipment Loan Payable (Tables)
Equipment Loan Payable (Tables) | 9 Months Ended |
Sep. 30, 2016 | |
Debt Disclosure [Abstract] | |
Schedule of Outstanding Borrowing Obligations | As of September 30, 2016 and December 31, 2015, the Company had the following outstanding borrowing obligations (in thousands): September 30, December 31, 2016 2015 Silicon Valley Bank Equipment Loan Payable $ 907 $ 1,344 Less: current portion (583 ) (583 ) Long-term debt, net $ 324 $ 761 |
Schedule of Maturities of Long Term Debt | The scheduled maturities of the Company’s long-term debt are as follows (in thousands): September 30, December 31, December 31, 2016 $ 146 $ 583 December 31, 2017 583 583 December 31, 2018 178 178 $ 907 $ 1,344 |
Nature of Business - Additional
Nature of Business - Additional Information (Detail) - USD ($) $ in Thousands | Sep. 29, 2016 | May 13, 2011 | Sep. 30, 2016 | Dec. 31, 2015 |
Nature Of Business And Basis Of Presentation [Line Items] | ||||
Proceeds from issuance of issuance of common stock, preferred stock and warrants, net of issuance costs | $ 27,700 | $ 27,674 | ||
Accumulated deficit | $ (190,836) | $ (165,565) | ||
ProChon [Member] | ||||
Nature Of Business And Basis Of Presentation [Line Items] | ||||
Business acquisition date | May 13, 2011 | |||
Consideration paid to acquisition | $ 2,224 |
Summary of Significant Accoun25
Summary of Significant Accounting Policies - Summary of Operations in Different Geographic Regions (Detail) - USD ($) $ in Thousands | Sep. 30, 2016 | Dec. 31, 2015 |
Segment Reporting Information [Line Items] | ||
Long-lived assets | $ 4,263 | $ 5,213 |
United States [Member] | ||
Segment Reporting Information [Line Items] | ||
Long-lived assets | 4,257 | 5,204 |
Israel [Member] | ||
Segment Reporting Information [Line Items] | ||
Long-lived assets | $ 6 | $ 9 |
Summary of Significant Accoun26
Summary of Significant Accounting Policies - Additional Information (Detail) - USD ($) | 9 Months Ended | ||
Sep. 30, 2016 | Sep. 30, 2015 | Dec. 31, 2015 | |
Summary Of Significant Accounting Policies [Line Items] | |||
Transfers between Levels 1, 2 and 3 | $ 0 | $ 0 | |
IPR&D [Member] | |||
Summary Of Significant Accounting Policies [Line Items] | |||
Impairment of intangible assets | 0 | $ 0 | |
Cash Deposits [Member] | |||
Summary Of Significant Accounting Policies [Line Items] | |||
Cash and cash equivalents, fair value | 30,204,000 | ||
Money Market Funds [Member] | |||
Summary Of Significant Accounting Policies [Line Items] | |||
Cash and cash equivalents, fair value | 7,790,000 | ||
Quoted Prices in Active Markets (Level 1) [Member] | |||
Summary Of Significant Accounting Policies [Line Items] | |||
Assets, fair value disclosure, recurring | 0 | $ 0 | |
Liabilities, fair value disclosure, recurring | 0 | 0 | |
Significant Other Observable Inputs (Level 2) [Member] | |||
Summary Of Significant Accounting Policies [Line Items] | |||
Assets, fair value disclosure, recurring | 0 | 0 | |
Liabilities, fair value disclosure, recurring | 0 | 0 | |
Significant Unobservable Inputs (Level 3) [Member] | |||
Summary Of Significant Accounting Policies [Line Items] | |||
Assets, fair value disclosure, recurring | 0 | 0 | |
Liabilities, fair value disclosure, recurring | $ 0 | $ 0 |
Summary of Significant Accoun27
Summary of Significant Accounting Policies - Schedule of Assets and Liabilities Measured at Fair Value on Recurring Basis (Detail) - USD ($) $ in Thousands | Sep. 30, 2016 | Dec. 31, 2015 |
Warrant Liability [Member] | ||
Liabilities: | ||
Liabilities, fair value | $ 30,165 | |
Money Market Funds [Member] | ||
Assets: | ||
Assets, fair value | 7,790 | $ 25,764 |
Quoted Prices in Active Markets (Level 1) [Member] | Money Market Funds [Member] | ||
Assets: | ||
Assets, fair value | 7,790 | $ 25,764 |
Significant Unobservable Inputs (Level 3) [Member] | Warrant Liability [Member] | ||
Liabilities: | ||
Liabilities, fair value | $ 30,165 |
Summary of Significant Accoun28
Summary of Significant Accounting Policies - Schedule of Reconciliation of Liabilities Measured at Fair Value (Detail) - Significant Unobservable Inputs (Level 3) [Member] $ in Thousands | 9 Months Ended |
Sep. 30, 2016USD ($) | |
Fair Value, Liabilities Measured on Recurring Basis, Unobservable Input Reconciliation [Line Items] | |
Issuance of warrants, | $ 30,704 |
Change in fair value of warrant liability | (539) |
Ending balance | $ 30,165 |
Summary of Significant Accoun29
Summary of Significant Accounting Policies - Summary of Intangible Assets, Net of Accumulated Impairment Charges (Detail) - USD ($) $ in Thousands | Sep. 30, 2016 | Dec. 31, 2015 |
Finite-Lived Intangible Assets [Line Items] | ||
Cost | $ 630 | $ 630 |
Accumulated Impairment | (430) | (430) |
Net Book Value | 200 | 200 |
IPR&D [Member] | ||
Finite-Lived Intangible Assets [Line Items] | ||
Cost | 630 | 630 |
Accumulated Impairment | (430) | (430) |
Net Book Value | $ 200 | $ 200 |
Loss Per Common Share - Schedul
Loss Per Common Share - Schedule of Basic and Diluted Loss Per Common Share (Detail) - USD ($) $ / shares in Units, $ in Thousands | 3 Months Ended | 9 Months Ended | ||
Sep. 30, 2016 | Sep. 30, 2015 | Sep. 30, 2016 | Sep. 30, 2015 | |
Numerator: | ||||
Net loss | $ (9,315) | $ (8,078) | $ (25,271) | $ (23,675) |
Net Loss attributable to Series A Preferred Stock | (81) | (74) | ||
Earnings (loss) attributable to common stockholders-basic and diluted | $ (9,234) | $ (8,078) | $ (25,197) | $ (23,675) |
Denominator: | ||||
Weighted-average number of common shares used in earnings (loss) per share-basic and diluted | 13,297,546 | 13,238,997 | 13,279,833 | 13,218,765 |
Earnings (loss) per share-basic and diluted | $ (0.70) | $ (0.61) | $ (1.90) | $ (1.79) |
Loss Per Common Share - Sched31
Loss Per Common Share - Schedule of Antidilutive Securities Excluded from Computation of Earnings Per Share (Detail) - shares | 3 Months Ended | 9 Months Ended | ||
Sep. 30, 2016 | Sep. 30, 2015 | Sep. 30, 2016 | Sep. 30, 2015 | |
Unvested Restricted Stock and Options to Purchase Common Stock [Member] | ||||
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] | ||||
Anti-dilutive securities excluded from computation of earnings per share | 882,887 | 1,233,494 | 882,887 | 1,233,494 |
Warrants Exercisable into Common Stock [Member] | ||||
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] | ||||
Anti-dilutive securities excluded from computation of earnings per share | 13,633,070 | 170,102 | 13,633,070 | 170,102 |
Property and Equipment - Schedu
Property and Equipment - Schedule of Property and Equipment (Detail) - USD ($) $ in Thousands | Sep. 30, 2016 | Dec. 31, 2015 |
Property, Plant and Equipment [Line Items] | ||
Total property and equipment | $ 13,519 | $ 13,202 |
Less: accumulated depreciation | (9,256) | (7,989) |
Property and equipment, net | 4,263 | 5,213 |
Office Equipment [Member] | ||
Property, Plant and Equipment [Line Items] | ||
Total property and equipment | 539 | 539 |
Laboratory Equipment [Member] | ||
Property, Plant and Equipment [Line Items] | ||
Total property and equipment | 4,442 | 4,337 |
Leasehold Improvements [Member] | ||
Property, Plant and Equipment [Line Items] | ||
Total property and equipment | 7,683 | 7,683 |
Construction in Progress [Member] | ||
Property, Plant and Equipment [Line Items] | ||
Total property and equipment | 759 | 547 |
Software [Member] | ||
Property, Plant and Equipment [Line Items] | ||
Total property and equipment | $ 96 | $ 96 |
Property and Equipment - Additi
Property and Equipment - Additional Information (Detail) - USD ($) $ in Thousands | 3 Months Ended | 9 Months Ended | ||
Sep. 30, 2016 | Sep. 30, 2015 | Sep. 30, 2016 | Sep. 30, 2015 | |
Property, Plant and Equipment [Abstract] | ||||
Depreciation expense | $ 404 | $ 414 | $ 1,267 | $ 1,182 |
Commitments and Contingencies -
Commitments and Contingencies - Additional Information (Detail) - USD ($) | 1 Months Ended | 3 Months Ended | 9 Months Ended | 12 Months Ended | |||||
Sep. 30, 2015 | Jun. 30, 2012 | Sep. 30, 2016 | Jun. 30, 2016 | Sep. 30, 2015 | Sep. 30, 2016 | Sep. 30, 2015 | Dec. 31, 2015 | Dec. 31, 2016 | |
Loss Contingencies [Line Items] | |||||||||
Rent expense under operating lease agreements | $ 248,000 | $ 266,000 | $ 742,000 | $ 857,000 | |||||
Research and development expense | 4,880,000 | $ 5,848,000 | $ 16,260,000 | $ 17,470,000 | |||||
Contractual agreement date | 2016-05 | ||||||||
Hydrogel License Agreement [Member] | |||||||||
Loss Contingencies [Line Items] | |||||||||
Research and development expense | $ 3,200,000 | ||||||||
One-time payment amount | 3,000,000 | 3,000,000 | |||||||
Tissue Regeneration License Agreement [Member] | |||||||||
Loss Contingencies [Line Items] | |||||||||
Research and development expense | 722,000 | ||||||||
One-time payment amount | 300,000 | $ 300,000 | |||||||
Percentage of royalty offsetting | 50.00% | ||||||||
Plasmid License Agreement [Member] | |||||||||
Loss Contingencies [Line Items] | |||||||||
Non-refundable license fee | 2,000 | $ 2,000 | |||||||
Minimum [Member] | Tissue Regeneration License Agreement [Member] | |||||||||
Loss Contingencies [Line Items] | |||||||||
Non-refundable royalty fee | 10,000 | ||||||||
Maximum [Member] | Waltham [Member] | |||||||||
Loss Contingencies [Line Items] | |||||||||
Construction allowances to total cost of tenant improvements | 3,184,000 | ||||||||
Maximum [Member] | Lexington [Member] | |||||||||
Loss Contingencies [Line Items] | |||||||||
Construction allowances to total cost of tenant improvements | 996,000 | ||||||||
Tissue Processor Sub License Agreement [Member] | |||||||||
Loss Contingencies [Line Items] | |||||||||
Research and development expense | 991,000 | ||||||||
Reimbursement for development cost | $ 250,000 | ||||||||
Additional non-refundable royalty fee | $ 30,000 | ||||||||
Additional non-refundable royalty fee payment description | 2016 through 2019 | ||||||||
Potential milestone payments | 10,200,000 | $ 10,200,000 | |||||||
Tissue Processor Sub License Agreement [Member] | Minimum [Member] | |||||||||
Loss Contingencies [Line Items] | |||||||||
Non-refundable royalty fee | $ 20,000 | ||||||||
Massachusetts [Member] | Waltham [Member] | |||||||||
Loss Contingencies [Line Items] | |||||||||
Lease expiration period | 2,023 | ||||||||
Engineering Agreement [Member] | |||||||||
Loss Contingencies [Line Items] | |||||||||
Amount paid to suppliers | $ 190,000 | $ 567,000 | |||||||
Additional payments due | 0 | 0 | |||||||
Collagen Supply Agreement [Member] | |||||||||
Loss Contingencies [Line Items] | |||||||||
Lease expiration period | 2,016 | ||||||||
Amount paid to suppliers | $ 93,000 | ||||||||
Minimum amount of material and/or services | $ 150,000 | ||||||||
Non-refundable payment | $ 123,000 | ||||||||
Initial term of the agreement | 3 years | ||||||||
Supplier agreement description | The initial term of the agreement is three years and will automatically renew from year to year thereafter unless otherwise terminated with at least 180 days' notice by either party. | ||||||||
Collagen Supply Agreement [Member] | Scenario, Forecast [Member] | |||||||||
Loss Contingencies [Line Items] | |||||||||
Additional payments due | $ 30,000 | ||||||||
OCS Agreement [Member] | |||||||||
Loss Contingencies [Line Items] | |||||||||
Accrued and received grants, aggregate | $ 1,100,000 | $ 1,100,000 | |||||||
OCS Agreement [Member] | Minimum [Member] | |||||||||
Loss Contingencies [Line Items] | |||||||||
Royalties payment, rate | 3.00% | ||||||||
Royalty payment percentage as percentage of grant received | 100.00% | ||||||||
OCS Agreement [Member] | Maximum [Member] | |||||||||
Loss Contingencies [Line Items] | |||||||||
Royalties payment, rate | 5.00% | ||||||||
Royalty payment percentage as percentage of grant received | 300.00% |
Capital Stock - Additional Info
Capital Stock - Additional Information (Detail) - USD ($) $ / shares in Units, $ in Thousands | Sep. 29, 2016 | Jul. 20, 2012 | Sep. 30, 2016 | Sep. 30, 2016 | Sep. 30, 2015 | Dec. 31, 2015 |
Class of Stock [Line Items] | ||||||
Common stock, shares issued | 15,871,965 | 15,871,965 | 13,273,470 | |||
Common stock price per share | $ 0.01 | $ 0.01 | $ 0.01 | |||
Preferred stock, shares issued | 24,158.8693 | 24,158.8693 | 0 | |||
Class of Warrants or right to purchase common stock | 156,138 | 156,138 | 156,138 | |||
Class of Warrants or right to purchase common stock, exercise price | $ 0.01 | $ 0.01 | $ 0.01 | |||
Warrants expiry period | 10 years | |||||
Fair value of warrants | $ 117 | |||||
Warrant expense | $ 3,056 | $ 3,056 | $ 15 | |||
Preferred stock par value | $ 0.01 | $ 0.01 | $ 0.01 | |||
Series A Preferred Stock [Member] | ||||||
Class of Stock [Line Items] | ||||||
Class of Warrants or right to purchase common stock | 161,977 | |||||
Class of Warrants or right to purchase common stock, exercise price | $ 0.01 | |||||
Private Placement [Member] | ||||||
Class of Stock [Line Items] | ||||||
Gross proceeds from issuance of common stock, preferred stock and warrants | $ 30,000 | |||||
Common stock, shares issued | 2,596,059 | |||||
Common stock price per share | $ 2.25 | |||||
Conversion of preferred stock in to common stock, preferred stock converted | 10,737,275 | 444.44 | ||||
Class of Warrants or right to purchase common stock | 13,333,334 | |||||
Class of Warrants or right to purchase common stock, exercise price | $ 2.25 | $ 2.25 | $ 2.25 | |||
Warrants granted to placement agent | 133,333 | |||||
Minimum percentage of outstanding common stock | 50.00% | |||||
Warrants expiry period | 5 years | |||||
Warrants exercisable period | 6 months | |||||
Fair value of warrants | $ 30,400 | $ 30,400 | ||||
Excess fair value of warrant liability | 400 | |||||
Warrant expense | $ 2,326 | |||||
Preferred stock par value | $ 0.01 | $ 0.01 | ||||
Private Placement [Member] | Members of Board of Directors [Member] | ||||||
Class of Stock [Line Items] | ||||||
Common stock, shares issued | 283,046 | 283,046 | ||||
Preferred stock, shares issued | 25,631,439 | 25,631,439 | ||||
Class of Warrants or right to purchase common stock | 1,422,221 | 1,422,221 | ||||
Class of Warrants or right to purchase common stock, exercise price | $ 2.25 | $ 2.25 | ||||
Private Placement [Member] | Series A Preferred Stock [Member] | ||||||
Class of Stock [Line Items] | ||||||
Preferred stock, shares issued | 241,588,693 |
Warrants - Additional Informati
Warrants - Additional Information (Detail) - USD ($) | Sep. 30, 2016 | Dec. 31, 2015 | Dec. 21, 2015 | Dec. 08, 2014 | Jul. 09, 2014 | Jul. 20, 2012 | Jul. 31, 2014 | Sep. 30, 2016 | Sep. 30, 2016 | Sep. 30, 2015 | Mar. 31, 2015 |
Class of Warrant or Right [Line Items] | |||||||||||
Class of Warrants or right to purchase common stock | 156,138 | 156,138 | 156,138 | 156,138 | |||||||
Class of Warrants or right to purchase common stock, exercise price | $ 0.01 | $ 0.01 | $ 0.01 | $ 0.01 | |||||||
Warrants expiry period | 10 years | ||||||||||
Warrant expense | $ 3,056,000 | $ 3,056,000 | $ 15,000 | ||||||||
Fair value of warrants | $ 117,000 | ||||||||||
Surrender of warrant to satisfy related liability | 5,839 | ||||||||||
Series A Preferred Stock [Member] | |||||||||||
Class of Warrant or Right [Line Items] | |||||||||||
Class of Warrants or right to purchase common stock | 161,977 | ||||||||||
Class of Warrants or right to purchase common stock, exercise price | $ 0.01 | ||||||||||
Silicon Valley Bank [Member] | |||||||||||
Class of Warrant or Right [Line Items] | |||||||||||
Class of Warrants or right to purchase common stock | 6,566 | ||||||||||
Class of Warrants or right to purchase common stock, exercise price | $ 7.99 | ||||||||||
Warrants expiry period | 10 years | ||||||||||
Fair value of warrants | $ 51,000 | ||||||||||
Fair value of the warrants, risk free interest rate | 2.58% | ||||||||||
Fair value of the warrants, implied volatility | 87.00% | ||||||||||
Fair value of the warrants, expected term to liquidity | 10 years | ||||||||||
Consulting Agreement Warrant [Member] | |||||||||||
Class of Warrant or Right [Line Items] | |||||||||||
Class of Warrants or right to purchase common stock | 7,398 | ||||||||||
Class of Warrants or right to purchase common stock, exercise price | $ 9.75 | ||||||||||
Warrants exercisable period | 24 months | ||||||||||
Warrants expiry period | 10 years | ||||||||||
Warrants, forfeiture | (3,699) | ||||||||||
Warrants vested and exercisable | 3,699 | 3,699 | |||||||||
Warrants, percentage of forfeiture | 50.00% | ||||||||||
Investor Warrants [Member] | |||||||||||
Class of Warrant or Right [Line Items] | |||||||||||
Class of Warrants or right to purchase common stock | 13,333,334 | 13,333,334 | 13,333,334 | ||||||||
Class of Warrants or right to purchase common stock, exercise price | $ 2.25 | $ 2.25 | $ 2.25 | ||||||||
Warrants exercisable period | 6 months | ||||||||||
Warrants expiry period | 5 years | ||||||||||
Warrant expense | $ 2,280 | ||||||||||
Placement Agent Warrant [Member] | |||||||||||
Class of Warrant or Right [Line Items] | |||||||||||
Class of Warrants or right to purchase common stock | 133,333 | 133,333 | 133,333 | ||||||||
Class of Warrants or right to purchase common stock, exercise price | $ 2.25 | $ 2.25 | $ 2.25 | ||||||||
Warrants expiry period | 5 years |
Stock-Based Compensation - Summ
Stock-Based Compensation - Summary of Stock Option Activity Under the 2012 and 2013 Plans (Detail) $ / shares in Units, $ in Thousands | 9 Months Ended |
Sep. 30, 2016USD ($)$ / sharesshares | |
Disclosure of Compensation Related Costs, Share-based Payments [Abstract] | |
Number of Options, Outstanding Beginning Balance | shares | 1,229,339 |
Number of Options, Granted | shares | 214,840 |
Number of Options, Exercised | shares | (3,685) |
Number of Options, Cancelled | shares | (111,430) |
Number of Options, Outstanding Ending Balance | shares | 1,329,064 |
Number of Options, Vested and expected to vest outstanding | shares | 1,248,103 |
Number of Options, Exercisable | shares | 449,478 |
Weighted Average Exercise Price, Outstanding Beginning Balance | $ / shares | $ 7.32 |
Weighted Average Exercise Price, Granted | $ / shares | 2.51 |
Weighted Average Exercise Price, Exercised | $ / shares | 0.76 |
Weighted Average Exercise Price, Cancelled | $ / shares | 4.92 |
Weighted Average Exercise Price, Outstanding Ending Balance | $ / shares | 6.77 |
Weighted Average Exercise Price, Vested and expected to vest outstanding | $ / shares | 6.78 |
Weighted Average Exercise Price, Exercisable | $ / shares | $ 7.05 |
Weighted Average Remaining Contractual Term, Outstanding | 8 years 4 months 24 days |
Weighted Average Remaining Contractual Term, Vested and expected to vest outstanding | 8 years 4 months 24 days |
Weighted Average Remaining Contractual Term, Exercisable | 7 years 10 months 24 days |
Aggregate Intrinsic Value, Outstanding | $ | $ 266 |
Aggregate Intrinsic Value, Vested and expected to vest outstanding | $ | 253 |
Aggregate Intrinsic Value, Exercisable | $ | $ 130 |
Stock-Based Compensation - Addi
Stock-Based Compensation - Additional Information (Detail) - USD ($) $ / shares in Units, $ in Thousands | 3 Months Ended | 9 Months Ended | ||
Sep. 30, 2016 | Sep. 30, 2015 | Sep. 30, 2016 | Sep. 30, 2015 | |
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||
Unrecognized compensation cost related to outstanding options | $ 2,744 | $ 2,744 | ||
Weighted average grant date fair value of vested options | $ 4.96 | |||
Weighted average grant date fair value of shares outstanding | $ 4.15 | 4.15 | ||
Weighted average grant date fair value per share of employee option granted | $ 2.47 | $ 3.22 | $ 1.40 | $ 4.55 |
Stock-based compensation expense | $ 435 | $ 362 | $ 1,080 | $ 854 |
Stock Options [Member] | ||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||
Unrecognized compensation cost, recognition period | 2 years 1 month 17 days | |||
Stock-based compensation expense | 434 | 361 | $ 1,078 | 851 |
Restricted Stock [Member] | ||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||
Unrecognized compensation cost, recognition period | 6 months 7 days | |||
Unrecognized compensation cost related to restricted stock awards | 1 | $ 1 | ||
Stock-based compensation expense | $ 1 | $ 1 | $ 2 | $ 3 |
Stock-Based Compensation - Sche
Stock-Based Compensation - Schedule of Restricted Stock Awards Under the 2012 and 2013 Plans (Detail) - Restricted Stock [Member] | 9 Months Ended |
Sep. 30, 2016$ / sharesshares | |
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |
Number of shares, Unvested beginning balance | shares | 5,190 |
Vesting of restricted stock | shares | (1,889) |
Number of shares, Unvested ending balance | shares | 3,301 |
Weighted-average grant date fair value, Unvested beginning balance | $ / shares | $ 1.07 |
Vesting of restricted stock | $ / shares | 0 |
Weighted-average grant date fair value, Unvested ending balance | $ / shares | $ 0.71 |
Stock-Based Compensation - Su40
Stock-Based Compensation - Summary of Stock-Based Compensation for all Options Granted and Restricted Stock Awards (Detail) - USD ($) $ in Thousands | 3 Months Ended | 9 Months Ended | ||
Sep. 30, 2016 | Sep. 30, 2015 | Sep. 30, 2016 | Sep. 30, 2015 | |
Share-based Compensation Arrangement by Share-based Payment Award, Compensation Cost [Line Items] | ||||
Stock-based compensation expense | $ 435 | $ 362 | $ 1,080 | $ 854 |
Research and Development [Member] | ||||
Share-based Compensation Arrangement by Share-based Payment Award, Compensation Cost [Line Items] | ||||
Stock-based compensation expense | 126 | 126 | 364 | 319 |
General and Administrative [Member] | ||||
Share-based Compensation Arrangement by Share-based Payment Award, Compensation Cost [Line Items] | ||||
Stock-based compensation expense | $ 309 | $ 236 | $ 716 | $ 535 |
Stock-Based Compensation - Su41
Stock-Based Compensation - Summary of Stock-Based Compensation by Award (Detail) - USD ($) $ in Thousands | 3 Months Ended | 9 Months Ended | ||
Sep. 30, 2016 | Sep. 30, 2015 | Sep. 30, 2016 | Sep. 30, 2015 | |
Share-based Compensation Arrangement by Share-based Payment Award, Compensation Cost [Line Items] | ||||
Stock-based compensation expense | $ 435 | $ 362 | $ 1,080 | $ 854 |
Stock Options [Member] | ||||
Share-based Compensation Arrangement by Share-based Payment Award, Compensation Cost [Line Items] | ||||
Stock-based compensation expense | 434 | 361 | 1,078 | 851 |
Restricted Stock [Member] | ||||
Share-based Compensation Arrangement by Share-based Payment Award, Compensation Cost [Line Items] | ||||
Stock-based compensation expense | $ 1 | $ 1 | $ 2 | $ 3 |
Stock-Based Compensation - Su42
Stock-Based Compensation - Summary of Weighted-Average Assumptions Used in the Black-Scholes Option Pricing Model to Determine the Fair Value of the Employee Stock Option Grants (Detail) | 3 Months Ended | 9 Months Ended | ||
Sep. 30, 2016 | Sep. 30, 2015 | Sep. 30, 2016 | Sep. 30, 2015 | |
Share-based Compensation Arrangement by Share-based Payment Award, Fair Value Assumptions and Methodology [Abstract] | ||||
Risk-free interest rate | 1.36% | 1.73% | 1.39% | 1.67% |
Expected volatility | 85.20% | 60.10% | 59.70% | 62.80% |
Expected term (in years) | 6 years 29 days | 6 years 29 days | 6 years 29 days | 6 years 15 days |
Expected dividend yield | 0.00% | 0.00% | 0.00% | 0.00% |
Stock-Based Compensation - Su43
Stock-Based Compensation - Summary of Weighted-Average Assumptions Used in the Black-Scholes Option Pricing Model to Determine the Fair Value of the Non-Employee Stock Option Grants (Detail) | 3 Months Ended | 9 Months Ended | ||
Sep. 30, 2016 | Sep. 30, 2015 | Sep. 30, 2016 | Sep. 30, 2015 | |
Share-based Goods and Nonemployee Services Transaction [Abstract] | ||||
Risk-free interest rate | 1.53% | 1.79% | 1.59% | 1.66% |
Expected volatility | 63.20% | 60.80% | 63.60% | 63.30% |
Expected term (in years) | 6 years 11 months 19 days | 7 years 5 months 23 days | 7 years | 5 years 9 months 22 days |
Expected dividend yield | 0.00% | 0.00% | 0.00% | 0.00% |
Equipment Loan Payable - Schedu
Equipment Loan Payable - Schedule of Outstanding Borrowing Obligations (Detail) - USD ($) $ in Thousands | Sep. 30, 2016 | Dec. 31, 2015 |
Debt Instrument [Line Items] | ||
Total debt | $ 907 | $ 1,344 |
Less: current portion | (583) | (583) |
Long-term debt, net | 324 | 761 |
Silicon Valley Bank [Member] | ||
Debt Instrument [Line Items] | ||
Total debt | $ 907 | $ 1,344 |
Equipment Loan Payable - Additi
Equipment Loan Payable - Additional Information (Detail) - USD ($) | 1 Months Ended | ||
Jul. 31, 2014 | Sep. 30, 2016 | Dec. 31, 2015 | |
Class of Warrant or Right [Line Items] | |||
Net exercise of warrants, shares | 156,138 | 156,138 | |
Net exercise of warrants, exercise price per share | $ 0.01 | $ 0.01 | |
Silicon Valley Bank [Member] | |||
Class of Warrant or Right [Line Items] | |||
Amount of loan to purchase equipment | $ 1,750,000 | ||
Line of credit facility, interest rate, stated percentage | 3.25% | ||
Bank loan and security agreement, repayment period | 36 months | ||
Net exercise of warrants, shares | 6,566 | ||
Net exercise of warrants, exercise price per share | $ 7.99 | ||
Borrowings outstanding under line of credit | $ 900,000 | $ 1,340,000 | |
Silicon Valley Bank [Member] | Prime Rate [Member] | |||
Class of Warrant or Right [Line Items] | |||
Amount of loan bears interest basis spread on variable rate | 2.75% |
Equipment Loan Payable - Sche46
Equipment Loan Payable - Schedule of Maturities of Long Term Debt (Detail) - USD ($) $ in Thousands | Sep. 30, 2016 | Dec. 31, 2015 |
Long-term Debt, Fiscal Year Maturity [Abstract] | ||
December 31, 2016 | $ 146 | $ 583 |
December 31, 2017 | 583 | 583 |
December 31, 2018 | 178 | 178 |
Total debt | $ 907 | $ 1,344 |
Related Parties - Additional In
Related Parties - Additional Information (Detail) - Intrexon [Member] - USD ($) $ in Thousands | 9 Months Ended | ||
Sep. 30, 2016 | Sep. 30, 2015 | Dec. 31, 2015 | |
Collaborative Arrangements and Non-collaborative Arrangement Transactions [Line Items] | |||
Collaboration Agreement cancellation notification | 90 days | ||
Collaboration Agreement cancellation with material breach that cannot be remedied | 60 days | ||
Accrued expenses due to related party | $ 2,802 | $ 1,546 | |
Commercialization Milestones [Member] | |||
Collaborative Arrangements and Non-collaborative Arrangement Transactions [Line Items] | |||
Commercialization milestones obligation | 12,000 | ||
Sales Milestones [Member] | |||
Collaborative Arrangements and Non-collaborative Arrangement Transactions [Line Items] | |||
Sales milestones | $ 22,500 | ||
Research and Development [Member] | |||
Collaborative Arrangements and Non-collaborative Arrangement Transactions [Line Items] | |||
Percentage of reimbursement expenses | 50.00% | ||
Percentage of reimbursement expenses subject to acceptance | 50.00% | ||
Research and development expense from transaction with Intrexon | $ 2,272 | $ 2,311 |