Document and Entity Information
Document and Entity Information - shares | 6 Months Ended | |
Jun. 30, 2016 | Aug. 01, 2016 | |
Document And Entity Information [Abstract] | ||
Document Type | 10-Q | |
Amendment Flag | false | |
Document Period End Date | Jun. 30, 2016 | |
Document Fiscal Year Focus | 2,016 | |
Document Fiscal Period Focus | Q2 | |
Trading Symbol | OCUL | |
Entity Registrant Name | Ocular Therapeutix, Inc. | |
Entity Central Index Key | 1,393,434 | |
Current Fiscal Year End Date | --12-31 | |
Entity Filer Category | Accelerated Filer | |
Entity Common Stock, Shares Outstanding | 24,821,530 |
Balance Sheets (Unaudited)
Balance Sheets (Unaudited) - USD ($) $ in Thousands | Jun. 30, 2016 | Dec. 31, 2015 |
Current assets: | ||
Cash and cash equivalents | $ 48,170 | $ 30,784 |
Marketable securities | 35,717 | 74,280 |
Accounts receivable | 223 | 193 |
Inventory | 149 | 134 |
Prepaid expenses and other current assets | 715 | 1,592 |
Total current assets | 84,974 | 106,983 |
Property and equipment, net | 3,199 | 3,095 |
Restricted cash | 1,728 | 228 |
Total assets | 89,901 | 110,306 |
Current liabilities: | ||
Accounts payable | 1,611 | 1,957 |
Accrued expenses and deferred rent | 2,342 | 3,379 |
Deferred revenue | 42 | |
Notes payable, net of discount, current | 2,466 | |
Total current liabilities | 6,419 | 5,378 |
Deferred rent, long-term | 42 | 68 |
Notes payable, net of discount, long-term | 12,992 | 15,272 |
Total liabilities | 19,453 | 20,718 |
Commitments and contingencies (Note 11) | ||
Stockholders' equity: | ||
Preferred stock, $0.0001 par value; 5,000,000 shares authorized at June 30, 2016 and December 31, 2015, no shares issued or outstanding at June 30, 2016 and December 31, 2015 | ||
Common stock, $0.0001 par value; 100,000,000 shares authorized at June 30, 2016 and December 31, 2015, 24,821,530 and 24,750,281 shares issued and outstanding at June 30, 2016 and December 31, 2015, respectively | 2 | 2 |
Additional paid-in capital | 221,897 | 218,830 |
Accumulated deficit | (151,461) | (129,176) |
Accumulated other comprehensive income (loss) | 10 | (68) |
Total stockholders' equity | 70,448 | 89,588 |
Total liabilities and stockholders' equity | $ 89,901 | $ 110,306 |
Balance Sheets (Unaudited) (Par
Balance Sheets (Unaudited) (Parenthetical) - $ / shares | Jun. 30, 2016 | Dec. 31, 2015 |
Statement of Financial Position [Abstract] | ||
Preferred stock, par value | $ 0.0001 | $ 0.0001 |
Preferred stock, shares authorized | 5,000,000 | 5,000,000 |
Preferred stock, shares issued | 0 | 0 |
Preferred stock, shares outstanding | 0 | 0 |
Common stock, par value | $ 0.0001 | $ 0.0001 |
Common stock, shares authorized | 100,000,000 | 100,000,000 |
Common stock, shares issued | 24,821,530 | 24,750,281 |
Common stock, shares outstanding | 24,821,530 | 24,750,281 |
Statements of Operations and Co
Statements of Operations and Comprehensive Loss (Unaudited) - USD ($) $ in Thousands | 3 Months Ended | 6 Months Ended | ||
Jun. 30, 2016 | Jun. 30, 2015 | Jun. 30, 2016 | Jun. 30, 2015 | |
Revenue: | ||||
Product revenue | $ 441 | $ 334 | $ 857 | $ 572 |
Collaboration revenue | 125 | 42 | 313 | |
Total revenue | 441 | 459 | 899 | 885 |
Costs and operating expenses: | ||||
Cost of product revenue | 105 | 80 | 204 | 136 |
Research and development | 6,978 | 6,743 | 14,051 | 11,462 |
Selling and marketing | 1,492 | 1,041 | 2,881 | 1,911 |
General and administrative | 2,973 | 2,230 | 5,379 | 4,124 |
Total costs and operating expenses | 11,548 | 10,094 | 22,515 | 17,633 |
Loss from operations | (11,107) | (9,635) | (21,616) | (16,748) |
Other income (expense): | ||||
Interest income | 80 | 28 | 167 | 68 |
Interest expense | (418) | (405) | (836) | (910) |
Other income (expense), net | 3 | 3 | ||
Total other expense, net | (338) | (374) | (669) | (839) |
Net loss | $ (11,445) | $ (10,009) | $ (22,285) | $ (17,587) |
Net loss per share, basic and diluted | $ (0.46) | $ (0.45) | $ (0.90) | $ (0.81) |
Weighted average common shares outstanding, basic and diluted | 24,770,059 | 22,167,274 | 24,761,498 | 21,765,087 |
Comprehensive loss: | ||||
Net loss | $ (11,445) | $ (10,009) | $ (22,285) | $ (17,587) |
Other comprehensive income (loss): | ||||
Unrealized gain (loss) on marketable securities | 10 | (8) | 78 | (8) |
Total other comprehensive income (loss) | 10 | (8) | 78 | (8) |
Total comprehensive loss | $ (11,435) | $ (10,017) | $ (22,207) | $ (17,595) |
Statements of Cash Flows (Unaud
Statements of Cash Flows (Unaudited) - USD ($) $ in Thousands | 6 Months Ended | |
Jun. 30, 2016 | Jun. 30, 2015 | |
Cash flows from operating activities: | ||
Net loss | $ (22,285) | $ (17,587) |
Adjustments to reconcile net loss to net cash used in operating activities | ||
Stock-based compensation expense | 2,864 | 2,073 |
Non-cash interest expense | 71 | 74 |
Depreciation and amortization expense | 412 | 360 |
Gain on disposal of property and equipment | (3) | |
Purchase of (premium) discount on marketable securities | (12) | 25 |
Amortization of premium on marketable securities, net | 153 | 39 |
Changes in operating assets and liabilities: | ||
Accounts receivable | (30) | 165 |
Prepaid expenses and other current assets | 877 | (749) |
Inventory | (15) | (12) |
Accounts payable | (462) | 651 |
Accrued expenses and deferred rent | (589) | (380) |
Deferred revenue | (42) | (63) |
Net cash used in operating activities | (19,058) | (15,407) |
Cash flows from investing activities: | ||
Purchases of property and equipment | (370) | (1,229) |
Purchases of investments | (11,500) | (17,500) |
Proceeds from sale of property and equipment | 7 | |
Change in restricted cash | (1,500) | |
Maturities of investments | 50,000 | 9,826 |
Net cash provided by (used in) investing activities | 36,630 | (8,896) |
Cash flows from financing activities: | ||
Proceeds from exercise of common stock options | 75 | 144 |
Proceeds from issuance of public offerings, net | 65,646 | |
Proceeds from issuance common stock pursuant to employee stock purchase plan | 128 | 148 |
Payments of insurance costs financed by a third-party | (389) | (342) |
Net cash (used in) provided by financing activities | (186) | 65,596 |
Net increase (decrease) in cash and cash equivalents | 17,386 | 41,293 |
Cash and cash equivalents at beginning of period | 30,784 | 37,393 |
Cash and cash equivalents at end of period | 48,170 | 78,686 |
Supplemental disclosure of non-cash investing and financing activities: | ||
Additions to property and equipment included in accounts payable and accrued expenses | $ 188 | 134 |
Deferred offering costs included in accounts payable and accrued expenses | $ 5 |
Nature of the Business and Basi
Nature of the Business and Basis of Presentation | 6 Months Ended |
Jun. 30, 2016 | |
Accounting Policies [Abstract] | |
Nature of the Business and Basis of Presentation | 1. Nature of the Business and Basis of Presentation Ocular Therapeutix, Inc. (the “Company”) was incorporated on September 12, 2006 under the laws of the State of Delaware. The Company is a biopharmaceutical company focused on the development and commercialization of innovative therapies for diseases and conditions of the eye using its proprietary hydrogel platform technology. The Company’s bioresorbable hydrogel-based product candidates are designed to provide sustained delivery of therapeutic agents to the eye. Since inception, the Company’s operations have been primarily focused on organizing and staffing the Company, acquiring rights to intellectual property, business planning, raising capital, developing its technology, identifying potential product candidates, undertaking preclinical studies and clinical trials, manufacturing initial quantities of its products and product candidates and building the initial sales and marketing infrastructure for the commercialization of the Company’s approved product and product candidates. The Company’s most advanced product candidate, DEXTENZA, is in Phase 3 clinical development for the treatment of post-surgical ocular inflammation and pain, and in September 2015, the Company submitted to the Food and Drug Administration (FDA) a New Drug Application, or NDA, for DEXTENZA for the treatment of post-surgical ocular pain. On July 25, 2016, the Company announced that it had received a Complete Response Letter, or CRL, from the FDA regarding the NDA for DEXTENZA. In the CRL, the concerns raised by the FDA pertain to deficiencies in manufacturing process and controls identified during a pre-NDA approval inspection of the Company’s manufacturing facility. The FDA’s letter did not provide any details as to which manufacturing deficiencies identified during the facility inspection remained open since the last response submitted by the Company. The satisfactory resolution of the manufacturing deficiencies identified during the FDA facility inspection is required before the NDA may be approved. The FDA’s letter did not identify any efficacy or safety concerns with respect to the clinical data provided in the NDA nor any need for additional clinical trials for the approval of the NDA. On August 3, 2016, the Company announced that it had received a letter from the FDA New England District Office (District Office) providing additional details pertaining to the manufacturing facility inspection observations. The FDA District Office letter stated that the corrective actions included in the Company’s prior responses appear as a whole to adequately address the ten inspectional observations raised in the Form 483 letter the Company received in February 2016 from the FDA, with one exception which relates to the proposed process for identity testing of an incoming inert gas component used in the Company’s manufacturing process. The FDA District Letter also requested evidence (e.g., a final report) when the planned migration of analytical testing from manual to an automatic integration is complete. There were no other issues identified in the FDA District Letter. The Company is subject to risks common to companies in the biotechnology industry including, but not limited to, new technological innovations, protection of proprietary technology, dependence on key personnel, compliance with government regulations, regulatory approval, uncertainty of market acceptance of products and the need to obtain additional financing. Product candidates currently under development will require significant additional research and development efforts, including extensive preclinical and clinical testing and regulatory approval, prior to commercialization. As of June 30, 2016, the Company’s lead product candidates were in development. There can be no assurance that the Company’s research and development will be successfully completed, that adequate protection for the Company’s intellectual property will be obtained, that any products developed will obtain necessary government regulatory approval and adequate reimbursement or that any approved products will be commercially viable. Even if the Company’s product development efforts are successful, it is uncertain when, if ever, the Company will generate significant revenue from product sales. The Company operates in an environment of rapid change in technology and substantial competition from pharmaceutical and biotechnology companies. In addition, the Company is dependent upon the services of its employees and consultants. The Company does not expect to generate significant revenue from sales of any product for several years, if at all. Accordingly, the Company will need to obtain additional capital to finance its operations. If the Company is unable to raise capital when needed or on attractive terms, the Company could be forced to delay, reduce or eliminate its research and development programs or any future commercialization efforts or to relinquish valuable rights to its technologies, future revenue streams, research programs or product candidates or grant licenses on terms that may not be favorable to the Company. Although management continues to pursue these plans, there is no assurance that the Company will be successful in obtaining sufficient funding on terms acceptable to the Company to fund continuing operations, if at all. The Company believes that its existing cash and cash equivalents and marketable securities will enable it to fund its operating expenses, debt service obligations and capital expenditure requirements through the third quarter of 2017. The accompanying financial statements have been prepared in conformity with accounting principles generally accepted in the United States of America (“GAAP”). Unaudited Interim Financial Information The balance sheet at December 31, 2015 was derived from audited financial statements, but does not include all disclosures required by GAAP. The accompanying unaudited financial statements as of June 30, 2016 and for the three and six months ended June 30, 2016 and 2015 have been prepared by the Company, pursuant to the rules and regulations of the Securities and Exchange Commission, (“SEC”), for interim financial statements. Certain information and footnote disclosures normally included in financial statements prepared in accordance with GAAP have been condensed or omitted pursuant to such rules and regulations. However, the Company believes that the disclosures are adequate to make the information presented not misleading. These financial statements should be read in conjunction with the Company’s audited financial statements and the notes thereto for the year ended December 31, 2015 included in the Company’s Annual Report on Form 10-K on file with the SEC. In the opinion of management, all adjustments, consisting only of normal recurring adjustments necessary for a fair statement of the Company’s financial position as of June 30, 2016 and results of operations and cash flows for the six months ended June 30, 2016 and 2015 have been made. The results of operations for the six months ended June 30, 2016 are not necessarily indicative of the results of operations that may be expected for the year ending December 31, 2016. |
Summary of Significant Accounti
Summary of Significant Accounting Policies | 6 Months Ended |
Jun. 30, 2016 | |
Accounting Policies [Abstract] | |
Summary of Significant Accounting Policies | 2. Summary of Significant Accounting Policies Use of Estimates The preparation of financial statements in conformity with GAAP requires management to make estimates and assumptions that affect the reported amounts of assets and liabilities, the disclosure of contingent assets and liabilities at the date of the financial statements, and the reported amounts of revenues and expenses during the reporting periods. Significant estimates and assumptions reflected in these financial statements include, but are not limited to, revenue recognition, the accrual of research and development expenses and the valuation of common stock and stock-based awards. Estimates are periodically reviewed in light of changes in circumstances, facts and experience. Actual results could differ from the Company’s estimates. Fair Value Measurements Certain assets and liabilities are carried at fair value under GAAP. Fair value is defined as the exchange price that would be received for an asset or paid to transfer a liability (an exit price) in the principal or most advantageous market for the asset or liability in an orderly transaction between market participants on the measurement date. Valuation techniques used to measure fair value must maximize the use of observable inputs and minimize the use of unobservable inputs. Financial assets and liabilities carried at fair value are to be classified and disclosed in one of the following three levels of the fair value hierarchy, of which the first two are considered observable and the last is considered unobservable: • Level 1—Quoted prices in active markets for identical assets or liabilities. • Level 2—Observable inputs (other than Level 1 quoted prices) such as quoted prices in active markets for similar assets or liabilities, quoted prices in markets that are not active for identical or similar assets or liabilities, or other inputs that are observable or can be corroborated by observable market data. • Level 3—Unobservable inputs that are supported by little or no market activity and that are significant to determining the fair value of the assets or liabilities, including pricing models, discounted cash flow methodologies and similar techniques. The Company’s cash equivalents and marketable securities at June 30, 2016 and December 31, 2015, were carried at fair value determined according to the fair value hierarchy described above (see Note 3). The carrying value of accounts receivable, accounts payable and accrued expenses approximate their fair value due to the short-term nature of these assets and liabilities. The carrying value of the Company’s outstanding notes payable (see Note 7) approximates fair value reflecting interest rates currently available to the Company. Marketable Securities The Company’s marketable securities are classified as available-for-sale and are carried at fair value with the unrealized gains and losses reported as a component of accumulated other comprehensive income (loss) in stockholders’ equity. Realized gains and losses and declines in value judged to be other than temporary are included as a component of other income (expense), net based on the specific identification method. Fair value is determined based on quoted market prices. At June 30, 2016, marketable securities by security type consisted of: Amortized Gross Gains Gross Unrealized Losses Estimated Fair Value United States treasury notes $ 33,518 $ 10 $ — $ 33,528 Agency bonds 2,189 — — 2,189 Total $ 35,707 $ 10 $ — $ 35,717 At December 31, 2015, marketable securities by security type consisted of: Amortized Cost Gross Unrealized Gains Gross Unrealized Losses Estimated Fair Value United States treasury notes $ 44,587 $ — $ (53 ) $ 44,534 Agency bonds 29,761 — (15 ) 29,746 Total $ 74,348 $ — $ (68 ) $ 74,280 At June 30, 2016 and December 31, 2015, marketable securities consisted of investments that mature within one year. Restricted Cash As of June 30, 2016 and December 31, 2015, the Company held a certificate of deposit of $1,728 and $228, respectively, as security deposits for the lease of the Company’s future and current corporate headquarters. In June 2016, the Company opened an additional certificate of deposit of $1,500 as a security deposit for the new lease related to the Company’s future corporate headquarters. (see Note 11) The Company has classified these as long-term restricted cash on its balance sheet. Segment Data The Company manages its operations as a single segment for the purposes of assessing performance and making operating decisions. The Company’s singular focus is on advancing its bioresorbable hydrogel-based product candidates exclusively for ophthalmology. All tangible assets are held in the United States. Comprehensive Loss Comprehensive loss includes net loss as well as other changes in stockholders’ equity (deficit) that result from transactions and economic events other than those with stockholders. Net Income (Loss) Per Share Basic net income (loss) per share is computed by dividing the net income (loss) by the weighted average number of common shares outstanding for the period. Diluted net income (loss) per share is computed by dividing the diluted net income (loss) by the weighted average number of common shares, including potential dilutive common shares assuming the dilutive effect of outstanding stock options, unvested restricted common shares and common stock warrants, as determined using the treasury stock method. For periods in which the Company has reported net losses, diluted net loss per share is the same as basic net loss per share, since dilutive common shares are not assumed to have been issued if their effect is anti-dilutive. The Company reported a net loss for the three and six months ended June 30, 2016 and 2015. The following common stock equivalents outstanding as of June 30, 2016 and 2015 were excluded from the computation of diluted net loss per share for the three and six months ended June 30, 2016 and 2015, because they had an anti-dilutive impact: As of June 30, 2016 2015 Options to purchase common stock 3,008,890 2,098,388 Non-vested restricted stock — 14,219 Warrants for the purchase of common stock 18,939 18,939 Total options, warrants and restricted stock 3,027,829 2,131,546 Recently Issued and Adopted Accounting Pronouncements In August 2014, the Financial Accounting Standards Board (“FASB”) issued Accounting Standards Update (“ASU”) 2014-15, Presentation of Financial Statements—Going Concern (Subtopic 205-40) . In May 2014, the FASB issued ASU No. 2014-09, Revenue from Contracts with Customers (Topic 606), (“ASU 2014-09”). ASU 2014-09 outlines a new, single comprehensive model for entities to use in accounting for revenue arising from contracts with customers and supersedes most current revenue recognition guidance, including industry-specific guidance. This new revenue recognition model provides a five-step analysis in determining when and how revenue is recognized. The new model will require revenue recognition to depict the transfer of promised goods or services to customers in an amount that reflects the consideration a company expects to receive in exchange for those goods or services. In August 2015, the FASB issued ASU No. 2015-14, Revenue from Contracts with Customers (Topic 606): Deferral of Effective Date. The amendments in ASU 2015-14 defer the effective date of ASU 2014-09 for all entities by one year. The standard will be effective for public entities for annual reporting periods beginning after December 15, 2017 and interim periods within those periods. Early adoption is permitted, but it cannot be any earlier than 2017 for calendar year-end entities. Companies may use either a full retrospective or a modified retrospective approach to adopt ASU 2014-09. The Company is currently assessing the impact that adopting this new accounting guidance will have on its financial statements and footnote disclosures. In February 2016, the FASB issued ASU No. 2016-02, Leases (ASC 842) (“ASU 2016-02”). ASU 2016-02 requires lessees to recognize most leases on the balance sheet. This is expected to increase both reported assets and liabilities. The new lease standard does not substantially change lessor accounting. For public companies, the standard will be effective for the first interim reporting period within annual periods beginning after December 15, 2018, although early adoption is permitted. Lessees and lessors will be required to apply the new standard at the beginning of the earliest period presented in the financial statements in which they first apply the new guidance, using a modified retrospective transition method. The requirements of this standard include a significant increase in required disclosures. The Company is currently assessing the impact that adopting this new accounting guidance will have on its financial statements and footnote disclosures. In March 2016, the FASB issued ASU No. 2016-08, Revenue from Contracts with Customers: Principal versus Agent Considerations (Reporting Revenue Gross versus Net) (“ASU 2016-08”). ASU 2016-08 clarifies the implementation guidance on principal versus agent considerations. The guidance includes indicators to assist an entity in determining whether it controls a specified good or service before it is transferred to the customers. The effective date and transition requirements for the amendments in this update are the same as the effective date and transition requirements for ASU 2014-09. The Company is currently assessing the impact that adopting this new accounting guidance will have on its financial statements and footnote disclosures. In March 2016, the FASB issued ASU No. 2016-09, Compensation – Stock Compensation (“ASU 2016-09”). ASU 2016-09 identifies areas for simplification involving several aspects of accounting for share-based payment transactions, including the income tax consequences, classification of awards as either equity or liabilities, an option to recognize gross stock compensation expense with actual forfeitures recognized as they occur, as well as certain classifications on the statement of cash flows. The amendments in this update will be effective for the first interim period within annual reporting periods beginning after December 15, 2016. Early adoption is permitted. The Company is currently assessing the impact that adopting this new accounting guidance will have on its financial statements and footnote disclosures. In April 2016, the FASB, issued ASU No. 2016-10, Identifying Performance Obligations and Licensing (Topic 606), (“ASU 2016-10”) which amends certain aspects of the FASB’s new revenue standard, ASU 2014-09. ASU 2016-10 identifies performance obligations and provides licensing implementation guidance. The effective date for ASU 2016-10 is the same as the effective date of ASU No. 2014-09. The standard will be effective for public entities for annual reporting periods beginning after December 15, 2017 and interim periods within those periods. The Company is currently assessing the impact that adopting this new accounting guidance will have on its financial statements and footnote disclosures. In May 2016, the FASB issued ASU No. 2016-12, Revenue from Contracts with Customers (Topic 606): Narrow-Scope Improvements and Practical Expedients (“ASU 2016-12”). ASU 2016-12 provides for amendments to ASU No. 2014-09, Revenue from Contracts with Customers, amending the guidance on transition, collectability, noncash consideration and the presentation of sales and other similar taxes. Specifically, ASU 2016-12 clarifies that, for a contract to be considered completed at transition, all (or substantially all) of the revenue must have been recognized under legacy GAAP. In addition, ASU 2016-12 clarifies how an entity should evaluate the collectability threshold and when an entity can recognize nonrefundable consideration received as revenue if an arrangement does not meet the standard’s contract criteria. The Company is currently assessing the impact that adopting this new accounting guidance will have on its financial statements and footnote disclosures. |
Fair Value of Financial Assets
Fair Value of Financial Assets and Liabilities | 6 Months Ended |
Jun. 30, 2016 | |
Fair Value Disclosures [Abstract] | |
Fair Value of Financial Assets and Liabilities | 3. Fair Value of Financial Assets and Liabilities The following tables present information about the Company’s assets and liabilities that are measured at fair value on a recurring basis as of June 30, 2016 and December 31, 2015 and indicate the level of the fair value hierarchy utilized to determine such fair value: Fair Value Measurements as of June 30, 2016 Using: Level 1 Level 2 Level 3 Total Assets: Cash equivalents: Money market funds $ — $ 47,805 $ — $ 47,805 Marketable securities: United States treasury notes — 33,528 — 33,528 Agency bonds — 2,189 — 2,189 Total $ — $ 83,522 $ — $ 83,522 Fair Value Measurements as of December 31, 2015 Using: Level 1 Level 2 Level 3 Total Assets: Cash equivalents: Money market funds $ — $ 29,879 $ — $ 29,879 Marketable securities: United States treasury notes — 44,534 — 44,534 Agency bonds — 29,746 — 29,746 Total $ — $ 104,159 $ — $ 104,159 |
Accrued Expenses
Accrued Expenses | 6 Months Ended |
Jun. 30, 2016 | |
Payables and Accruals [Abstract] | |
Accrued Expenses | 4. Accrued Expenses Accrued expenses consisted of the following: June 30, 2016 December 31, 2015 Accrued payroll and related expenses $ 1,003 $ 1,582 Accrued professional fees 577 471 Accrued research and development expenses 193 430 Accrued insurance — 389 Accrued other 569 507 $ 2,342 $ 3,379 As of December 31, 2015, the Company’s accrued insurance represents premiums for the period from July 2015 through June 2016 which the Company financed with a third-party. |
Income Taxes
Income Taxes | 6 Months Ended |
Jun. 30, 2016 | |
Income Tax Disclosure [Abstract] | |
Income Taxes | 5. Income Taxes The Company did not provide for any income taxes in its statement of operations for the three and six month periods ended June 30, 2016 or 2015. The Company has provided a valuation allowance for the full amount of its net deferred tax assets because, at June 30, 2016 and December 31, 2015, it was more likely than not that any future benefit from deductible temporary differences and net operating loss and tax credit carryforwards would not be realized. The Company has not recorded any amounts for unrecognized tax benefits as of June 30, 2016 or December 31, 2015. As of June 30, 2016 and December 31, 2015, the Company had no accrued interest or tax penalties recorded related to income taxes. The Company’s income tax return reporting periods since December 31, 2012 are open to income tax audit examination by the federal and state tax authorities. In addition, because the Company has net operating loss carryforwards, the Internal Revenue Service is permitted to audit earlier years and propose adjustments up to the amount of net operating losses generated in those years. |
Feasibility Agreements
Feasibility Agreements | 6 Months Ended |
Jun. 30, 2016 | |
Organization, Consolidation and Presentation of Financial Statements [Abstract] | |
Feasibility Agreements | 6. Feasibility Agreements The Company had a feasibility agreement with a biotechnology company, entered into in 2014. Under this agreement, the biotechnology company would pay up to $700, of which $250 was a non-refundable payment due upon contract execution and $450 was due upon the achievement of certain milestones. The Company recognized the total expected payments under the contract which included only the non-refundable payments on a straight-line basis over the estimated performance period. When a contingent milestone payment was earned, the additional consideration to be received was added to the total expected payments under the contract then recognized over the estimated performance period. In January 2015, the first milestone under the feasibility agreement was achieved triggering a non-refundable payment due of $250 such that the total non-refundable payments that were recognized over the estimated performance period totaled $500. This agreement was terminated in the second quarter of 2016 and the Company does not have any further obligations. The Company recognized no revenue and $125 of revenue for the three months ended June 30, 2016 and 2015, respectively. The Company recognized $42 and $313 of revenue for the six months ended June 30, 2016 and 2015, respectively. As of June 30, 2016, the Company had no deferred revenue. As of December 31, 2015, the Company had deferred revenue of $42. |
Notes Payable
Notes Payable | 6 Months Ended |
Jun. 30, 2016 | |
Debt Disclosure [Abstract] | |
Notes Payable | 7. Notes Payable The Company has outstanding borrowings under a credit and security agreement entered into in 2014 and amended in December 2015 (the “Amended 2014 Credit Facility”) totaling $15,600, which is collateralized by substantially all of the Company’s personal property, other than its intellectual property. The Company is obligated to make monthly interest-only payments under the Amended 2014 Credit Facility until December 31, 2016 and, thereafter, is required to make monthly payments of principal and interest from January 1, 2017 through December 1, 2019. The stated interest rate under the Amended 2014 Credit Facility is 8.25%. In addition, a final payment equal to 3.75% of amounts drawn under the Amended 2014 Credit Facility is due upon the new maturity date. The effective annual interest rate of the outstanding debt under the Amended 2014 Credit Facility is 10.6%. There are no financial covenants associated with the Amended 2014 Credit Facility; however, there are negative covenants restricting the Company’s activities, including limitations on dispositions, mergers or acquisitions; encumbering its intellectual property; incurring indebtedness or liens; paying dividends; making certain investments; and engaging in certain other business transactions. The obligations under the Amended 2014 Credit Facility are subject to acceleration upon the occurrence of specified events of default, including a material adverse change in the Company’s business, operations or financial or other condition. On June 20, 2016, the Company entered into a First Amendment (the “First Amendment”) to the Amended 2014 Credit Facility to revise the definition of “Permitted Liens” to include a security deposit letter of credit as a permitted lien. There were no other changes to the Amended 2014 Credit Facility. As of June 30, 2016, the annual repayment requirements for the Amended 2014 Credit Facility, inclusive of the final payment of $585 due at expiration, were as follows: Year Ending December 31, Principal Interest and Final Payment Total 2016 $ — $ 656 $ 656 2017 5,200 1,105 6,305 2018 5,200 670 5,870 2019 5,200 820 6,020 $ 15,600 $ 3,251 $ 18,851 |
Common Stock and Preferred Stoc
Common Stock and Preferred Stock | 6 Months Ended |
Jun. 30, 2016 | |
Equity [Abstract] | |
Common Stock and Preferred Stock | 8. Common Stock and Preferred Stock On July 30, 2014, the Company completed its IPO, which resulted in the sale of 5,000,000 shares of its common stock at a public offering price of $13.00 per share resulting in net proceeds of approximately $57,337 after deducting underwriting discounts and other offering costs. Upon closing the IPO, all outstanding shares of the Company’s redeemable convertible preferred stock were automatically converted into 12,440,205 shares of common stock. Additionally upon closing the IPO, the Company adopted an amended and restated certificate of incorporation increasing the number of its authorized shares of its common stock to 100,000,000 shares. In conjunction with the IPO and the amended and restated certificate of incorporation, the Company is authorized to issue 5,000,000 shares of preferred stock, $0.0001 par value, all of which is undesignated. On August 19, 2014, the Company completed the sale of an additional 750,000 shares of common stock at the initial public offering price of $13.00 per share to the underwriters of the Company’s IPO pursuant to the exercise of their over-allotment option. The Company received additional net proceeds of approximately $9,068 after deducting underwriting discounts. In June 2015, the Company completed a follow-on offering of its common stock at a public offering price of $22.00 per share. The offering consisted of 4,600,000 shares of common stock, of which 3,200,000 shares were issued and sold by the Company and 1,400,000 shares were sold by certain stockholders of the Company, including those shares sold in connection with the exercise by the underwriters of their option to purchase additional shares. The Company received net proceeds from the follow-on offering of approximately $65,612 after deducting underwriting discounts and offering expenses. |
Warrants
Warrants | 6 Months Ended |
Jun. 30, 2016 | |
Text Block [Abstract] | |
Warrants | 9. Warrants Warrants for the purchase of 18,939 shares of common stock remain outstanding at June 30, 2016 at a weighted average exercise price of $7.92 per share and an expiration date of April 17, 2021. No warrants were exercised during the six months ended June 30, 2016. During the six months ended June 30, 2015, warrants covering 70,769 shares were exercised via net share settlement and the Company issued 54,010 shares of common stock as a result of the exercise. |
Stock-Based Awards
Stock-Based Awards | 6 Months Ended |
Jun. 30, 2016 | |
Disclosure of Compensation Related Costs, Share-based Payments [Abstract] | |
Stock-Based Awards | 10. Stock-Based Awards 2014 Stock Incentive Plan The 2014 Stock Incentive Plan (the “2014 Plan”) provides for the grant of incentive stock options, non-statutory stock options, restricted stock awards, restricted stock units, stock appreciation rights and other stock-based awards. The number of shares of common stock that may be issued under the 2014 Plan is subject to increase on the first day of each fiscal year, beginning on January 1, 2015 and ending on December 31, 2024 in an amount equal to the lesser of a pre-determined formula or as determined by the Company’s board of directors. On January 1, 2016, the number of shares available for issuance under the 2014 Plan increased by 990,012. As of June 30, 2016, 1,493,039 shares remained available for issuance under the 2014 Plan. 2014 Employee Stock Purchase Plan The Company has a 2014 Employee Stock Purchase Plan (the “ESPP”). The number of shares of common stock that may be issued under the ESPP will automatically increase on the first day of each fiscal year, commencing on January 1, 2015 and ending on December 31, 2024 in an amount equal to the lesser of a pre-determined formula or as determined by the Company’s board of directors. On January 1, 2016, the number of shares available for issuance under the 2014 Plan increased by 123,752. During the six months ended June 30, 2016, 30,501 shares of common stock were issued for total proceeds of $128. As of June 30, 2016, 299,342 shares remained available for issuance under the ESPP. Stock-based Compensation The Company recorded stock-based compensation expense related to stock options and restricted common stock in the following expense categories of its statements of operations: Three Months Ended June 30, Six Months Ended June 30. 2016 2015 2016 2015 Research and development $ 522 $ 415 $ 975 $ 717 Selling and marketing 128 95 235 158 General and administrative 865 642 1,654 1,198 $ 1,515 $ 1,152 $ 2,864 $ 2,073 As of June 30, 2016, the Company had an aggregate of $12,604 of unrecognized stock-based compensation cost, which is expected to be recognized over a weighted average period of 2.53 years. As of June 30, 2016, there were outstanding unvested service-based stock options held by nonemployees for the purchase of 9,156 shares of common stock. |
Commitments and Contingencies
Commitments and Contingencies | 6 Months Ended |
Jun. 30, 2016 | |
Commitments and Contingencies Disclosure [Abstract] | |
Commitments and Contingencies | 11. Commitments and Contingencies Leases The Company leases office, laboratory and manufacturing space in Bedford, Massachusetts and certain office equipment under non-cancelable operating leases that expire in June 2017, June 2018 and July 2027. Future minimum lease payments as of June 30, 2016 for its operating leases that expire in June 2017 and June 2018 are as follows: Years Ending December 31, 2016 $ 414 2017 676 2018 262 Total $ 1,352 During the three months ended June 30, 2016 and 2015, the Company recognized $194 and $195, respectively, of rental expense, related to its office, laboratory and manufacturing space and office equipment. During the six months ended June 30, 2016 and 2015, the Company recognized $388 and $390, respectively, of rental expense, related to its office, laboratory and manufacturing space and office equipment. On June 17, 2016, the Company entered into a lease agreement for approximately 70,712 square feet of general office, research and development and manufacturing space in Bedford, Massachusetts. The lease term will commence on February 1, 2017 and expire on July 31, 2027. No base rent will be due under the lease until August 1, 2017. The initial annual base rent is approximately $1,200 and will increase annually beginning on February 1 of each year. The Company is obligated to pay all real estate taxes and costs related to the premises, including costs of operations, maintenance, repair, and replacement and management of the new leased premises. The Company posted a customary letter of credit in the amount of approximately $1,500 as a security deposit. The Company intends to relocate its corporate headquarters to the new leased premises beginning in 2017 and intends to relocate all of its operations to the new leased premises by 2018. The lease agreement allows for a construction allowance not to exceed approximately $2,800 to be applied to the total construction costs of the new leased premises. The construction allowance must be used on or before December 31, 2017, or it will be deemed forfeited with no further obligation by the landlord of the new leased premises. Future minimum lease payments as of June 30, 2016 for its operating lease expiring in July 2027 are as follows: Years Ending December 31, 2016 $ — 2017 486 2018 1,199 2019 1,235 2020 1,270 Thereafter 9,245 Total $ 13,435 Intellectual Property Licenses The Company has a license agreement with Incept, LLC (“Incept”) (Note 12) to use and develop certain patent rights (the “Incept License”). Under the Incept License, as amended and restated, the Company was granted a worldwide, perpetual, exclusive license to develop and commercialize products that are delivered to or around the human eye for diagnostic, therapeutic or prophylactic purposes relating to ophthalmic diseases or conditions. The Company is obligated to pay low single-digit royalties on net sales of commercial products developed using the licensed technology, commencing with the date of the first commercial sale of such products and until the expiration of the last to expire of the patents covered by the license. Any of the Company’s sublicensees also will be obligated to pay Incept a royalty equal to a low single-digit percentage of net sales made by it and will be bound by the terms of the agreement to the same extent as the Company. The Company is obligated to reimburse Incept for its share of the reasonable fees and costs incurred by Incept in connection with the prosecution of the patent applications licensed to the Company under the Incept License. Through June 30, 2016, royalties paid under this agreement related to product sales were $67. Indemnification Agreements In the ordinary course of business, the Company may provide indemnification of varying scope and terms to vendors, lessors, business partners, and other parties with respect to certain matters including, but not limited to, losses arising out of breach of such agreements or from intellectual property infringement claims made by third parties. In addition, the Company has entered into indemnification agreements with members of its board of directors that will require the Company, among other things, to indemnify them against certain liabilities that may arise by reason of their status or service as directors or officers. The maximum potential amount of future payments the Company could be required to make under these indemnification agreements is, in many cases, unlimited. To date, the Company has not incurred any material costs as a result of such indemnifications. The Company does not believe that the outcome of any claims under indemnification arrangements will have a material effect on its financial position, results of operations or cash flows, and it has not accrued any liabilities related to such obligations in its financial statements as of December 31, 2015 or June 30, 2016. Purchase Commitments Purchase commitments represent non-cancelable contractual commitments associated with certain clinical trial activities within the clinical research organization. Manufacturing Commitments Manufacturing contracts generally provide for termination on notice, and therefore are cancelable contracts but are contracts that the Company is likely to continue, regardless of the fact that they are cancelable. |
Related Party Transactions
Related Party Transactions | 6 Months Ended |
Jun. 30, 2016 | |
Related Party Transactions [Abstract] | |
Related Party Transactions | 12. Related Party Transactions The Company has a license agreement with Incept to use and develop certain patent rights that it entered into in 2007. Incept and certain owners of Incept are shareholders of the Company. In addition, certain employees of the Company are shareholders of Incept. The Company’s President and Chief Executive Officer (CEO) is a general partner of Incept. In April 2014, the Company granted 28,437 shares of restricted common stock to its CEO, which grant was in lieu of $250 of the CEO’s 2015 base salary. During 2015, due to an administrative error, the Company did not appropriately adjust the base salary to reflect this reduction. As a result, the Company paid the full base salary for 2015. Upon discovery of the error, the CEO promptly repaid the full $250 to the Company on April 1, 2016. The Company recorded a reduction to payroll expense in the first quarter of 2016. The effect of this error on the statement of operations was considered immaterial for all related periods. |
Summary of Significant Accoun18
Summary of Significant Accounting Policies (Policies) | 6 Months Ended |
Jun. 30, 2016 | |
Accounting Policies [Abstract] | |
Use of Estimates | Use of Estimates The preparation of financial statements in conformity with GAAP requires management to make estimates and assumptions that affect the reported amounts of assets and liabilities, the disclosure of contingent assets and liabilities at the date of the financial statements, and the reported amounts of revenues and expenses during the reporting periods. Significant estimates and assumptions reflected in these financial statements include, but are not limited to, revenue recognition, the accrual of research and development expenses and the valuation of common stock and stock-based awards. Estimates are periodically reviewed in light of changes in circumstances, facts and experience. Actual results could differ from the Company’s estimates. |
Fair Value Measurements | Fair Value Measurements Certain assets and liabilities are carried at fair value under GAAP. Fair value is defined as the exchange price that would be received for an asset or paid to transfer a liability (an exit price) in the principal or most advantageous market for the asset or liability in an orderly transaction between market participants on the measurement date. Valuation techniques used to measure fair value must maximize the use of observable inputs and minimize the use of unobservable inputs. Financial assets and liabilities carried at fair value are to be classified and disclosed in one of the following three levels of the fair value hierarchy, of which the first two are considered observable and the last is considered unobservable: • Level 1—Quoted prices in active markets for identical assets or liabilities. • Level 2—Observable inputs (other than Level 1 quoted prices) such as quoted prices in active markets for similar assets or liabilities, quoted prices in markets that are not active for identical or similar assets or liabilities, or other inputs that are observable or can be corroborated by observable market data. • Level 3—Unobservable inputs that are supported by little or no market activity and that are significant to determining the fair value of the assets or liabilities, including pricing models, discounted cash flow methodologies and similar techniques. The Company’s cash equivalents and marketable securities at June 30, 2016 and December 31, 2015, were carried at fair value determined according to the fair value hierarchy described above (see Note 3). The carrying value of accounts receivable, accounts payable and accrued expenses approximate their fair value due to the short-term nature of these assets and liabilities. The carrying value of the Company’s outstanding notes payable (see Note 7) approximates fair value reflecting interest rates currently available to the Company. |
Marketable Securities | Marketable Securities The Company’s marketable securities are classified as available-for-sale and are carried at fair value with the unrealized gains and losses reported as a component of accumulated other comprehensive income (loss) in stockholders’ equity. Realized gains and losses and declines in value judged to be other than temporary are included as a component of other income (expense), net based on the specific identification method. Fair value is determined based on quoted market prices. At June 30, 2016, marketable securities by security type consisted of: Amortized Gross Gains Gross Unrealized Losses Estimated Fair Value United States treasury notes $ 33,518 $ 10 $ — $ 33,528 Agency bonds 2,189 — — 2,189 Total $ 35,707 $ 10 $ — $ 35,717 At December 31, 2015, marketable securities by security type consisted of: Amortized Cost Gross Unrealized Gains Gross Unrealized Losses Estimated Fair Value United States treasury notes $ 44,587 $ — $ (53 ) $ 44,534 Agency bonds 29,761 — (15 ) 29,746 Total $ 74,348 $ — $ (68 ) $ 74,280 At June 30, 2016 and December 31, 2015, marketable securities consisted of investments that mature within one year. |
Restricted Cash | Restricted Cash As of June 30, 2016 and December 31, 2015, the Company held a certificate of deposit of $1,728 and $228, respectively, as security deposits for the lease of the Company’s future and current corporate headquarters. In June 2016, the Company opened an additional certificate of deposit of $1,500 as a security deposit for the new lease related to the Company’s future corporate headquarters. (see Note 11) The Company has classified these as long-term restricted cash on its balance sheet. |
Segment Data | Segment Data The Company manages its operations as a single segment for the purposes of assessing performance and making operating decisions. The Company’s singular focus is on advancing its bioresorbable hydrogel-based product candidates exclusively for ophthalmology. All tangible assets are held in the United States. |
Comprehensive Loss | Comprehensive Loss Comprehensive loss includes net loss as well as other changes in stockholders’ equity (deficit) that result from transactions and economic events other than those with stockholders. |
Net Income (Loss) Per Share | Net Income (Loss) Per Share Basic net income (loss) per share is computed by dividing the net income (loss) by the weighted average number of common shares outstanding for the period. Diluted net income (loss) per share is computed by dividing the diluted net income (loss) by the weighted average number of common shares, including potential dilutive common shares assuming the dilutive effect of outstanding stock options, unvested restricted common shares and common stock warrants, as determined using the treasury stock method. For periods in which the Company has reported net losses, diluted net loss per share is the same as basic net loss per share, since dilutive common shares are not assumed to have been issued if their effect is anti-dilutive. The Company reported a net loss for the three and six months ended June 30, 2016 and 2015. The following common stock equivalents outstanding as of June 30, 2016 and 2015 were excluded from the computation of diluted net loss per share for the three and six months ended June 30, 2016 and 2015, because they had an anti-dilutive impact: As of June 30, 2016 2015 Options to purchase common stock 3,008,890 2,098,388 Non-vested restricted stock — 14,219 Warrants for the purchase of common stock 18,939 18,939 Total options, warrants and restricted stock 3,027,829 2,131,546 |
Recently Issued and Adopted Accounting Pronouncements | Recently Issued and Adopted Accounting Pronouncements In August 2014, the Financial Accounting Standards Board (“FASB”) issued Accounting Standards Update (“ASU”) 2014-15, Presentation of Financial Statements—Going Concern (Subtopic 205-40) . In May 2014, the FASB issued ASU No. 2014-09, Revenue from Contracts with Customers (Topic 606), (“ASU 2014-09”). ASU 2014-09 outlines a new, single comprehensive model for entities to use in accounting for revenue arising from contracts with customers and supersedes most current revenue recognition guidance, including industry-specific guidance. This new revenue recognition model provides a five-step analysis in determining when and how revenue is recognized. The new model will require revenue recognition to depict the transfer of promised goods or services to customers in an amount that reflects the consideration a company expects to receive in exchange for those goods or services. In August 2015, the FASB issued ASU No. 2015-14, Revenue from Contracts with Customers (Topic 606): Deferral of Effective Date. The amendments in ASU 2015-14 defer the effective date of ASU 2014-09 for all entities by one year. The standard will be effective for public entities for annual reporting periods beginning after December 15, 2017 and interim periods within those periods. Early adoption is permitted, but it cannot be any earlier than 2017 for calendar year-end entities. Companies may use either a full retrospective or a modified retrospective approach to adopt ASU 2014-09. The Company is currently assessing the impact that adopting this new accounting guidance will have on its financial statements and footnote disclosures. In February 2016, the FASB issued ASU No. 2016-02, Leases (ASC 842) (“ASU 2016-02”). ASU 2016-02 requires lessees to recognize most leases on the balance sheet. This is expected to increase both reported assets and liabilities. The new lease standard does not substantially change lessor accounting. For public companies, the standard will be effective for the first interim reporting period within annual periods beginning after December 15, 2018, although early adoption is permitted. Lessees and lessors will be required to apply the new standard at the beginning of the earliest period presented in the financial statements in which they first apply the new guidance, using a modified retrospective transition method. The requirements of this standard include a significant increase in required disclosures. The Company is currently assessing the impact that adopting this new accounting guidance will have on its financial statements and footnote disclosures. In March 2016, the FASB issued ASU No. 2016-08, Revenue from Contracts with Customers: Principal versus Agent Considerations (Reporting Revenue Gross versus Net) (“ASU 2016-08”). ASU 2016-08 clarifies the implementation guidance on principal versus agent considerations. The guidance includes indicators to assist an entity in determining whether it controls a specified good or service before it is transferred to the customers. The effective date and transition requirements for the amendments in this update are the same as the effective date and transition requirements for ASU 2014-09. The Company is currently assessing the impact that adopting this new accounting guidance will have on its financial statements and footnote disclosures. In March 2016, the FASB issued ASU No. 2016-09, Compensation – Stock Compensation (“ASU 2016-09”). ASU 2016-09 identifies areas for simplification involving several aspects of accounting for share-based payment transactions, including the income tax consequences, classification of awards as either equity or liabilities, an option to recognize gross stock compensation expense with actual forfeitures recognized as they occur, as well as certain classifications on the statement of cash flows. The amendments in this update will be effective for the first interim period within annual reporting periods beginning after December 15, 2016. Early adoption is permitted. The Company is currently assessing the impact that adopting this new accounting guidance will have on its financial statements and footnote disclosures. In April 2016, the FASB, issued ASU No. 2016-10, Identifying Performance Obligations and Licensing (Topic 606), (“ASU 2016-10”) which amends certain aspects of the FASB’s new revenue standard, ASU 2014-09. ASU 2016-10 identifies performance obligations and provides licensing implementation guidance. The effective date for ASU 2016-10 is the same as the effective date of ASU No. 2014-09. The standard will be effective for public entities for annual reporting periods beginning after December 15, 2017 and interim periods within those periods. The Company is currently assessing the impact that adopting this new accounting guidance will have on its financial statements and footnote disclosures. In May 2016, the FASB issued ASU No. 2016-12, Revenue from Contracts with Customers (Topic 606): Narrow-Scope Improvements and Practical Expedients (“ASU 2016-12”). ASU 2016-12 provides for amendments to ASU No. 2014-09, Revenue from Contracts with Customers, amending the guidance on transition, collectability, noncash consideration and the presentation of sales and other similar taxes. Specifically, ASU 2016-12 clarifies that, for a contract to be considered completed at transition, all (or substantially all) of the revenue must have been recognized under legacy GAAP. In addition, ASU 2016-12 clarifies how an entity should evaluate the collectability threshold and when an entity can recognize nonrefundable consideration received as revenue if an arrangement does not meet the standard’s contract criteria. The Company is currently assessing the impact that adopting this new accounting guidance will have on its financial statements and footnote disclosures. |
Summary of Significant Accoun19
Summary of Significant Accounting Policies (Tables) | 6 Months Ended |
Jun. 30, 2016 | |
Accounting Policies [Abstract] | |
Summary of Marketable Securities by Security Type | At June 30, 2016, marketable securities by security type consisted of: Amortized Gross Gains Gross Unrealized Losses Estimated Fair Value United States treasury notes $ 33,518 $ 10 $ — $ 33,528 Agency bonds 2,189 — — 2,189 Total $ 35,707 $ 10 $ — $ 35,717 At December 31, 2015, marketable securities by security type consisted of: Amortized Cost Gross Unrealized Gains Gross Unrealized Losses Estimated Fair Value United States treasury notes $ 44,587 $ — $ (53 ) $ 44,534 Agency bonds 29,761 — (15 ) 29,746 Total $ 74,348 $ — $ (68 ) $ 74,280 |
Schedule of Antidilutive Securities, Excluded from Computation of Diluted Net Loss per Share | The following common stock equivalents outstanding as of June 30, 2016 and 2015 were excluded from the computation of diluted net loss per share for the three and six months ended June 30, 2016 and 2015, because they had an anti-dilutive impact: As of June 30, 2016 2015 Options to purchase common stock 3,008,890 2,098,388 Non-vested restricted stock — 14,219 Warrants for the purchase of common stock 18,939 18,939 Total options, warrants and restricted stock 3,027,829 2,131,546 |
Fair Value of Financial Asset20
Fair Value of Financial Assets and Liabilities (Tables) | 6 Months Ended |
Jun. 30, 2016 | |
Fair Value Disclosures [Abstract] | |
Schedule of Assets and Liabilities Measured at Fair Value on Recurring Basis | The following tables present information about the Company’s assets and liabilities that are measured at fair value on a recurring basis as of June 30, 2016 and December 31, 2015 and indicate the level of the fair value hierarchy utilized to determine such fair value: Fair Value Measurements as of June 30, 2016 Using: Level 1 Level 2 Level 3 Total Assets: Cash equivalents: Money market funds $ — $ 47,805 $ — $ 47,805 Marketable securities: United States treasury notes — 33,528 — 33,528 Agency bonds — 2,189 — 2,189 Total $ — $ 83,522 $ — $ 83,522 Fair Value Measurements as of December 31, 2015 Using: Level 1 Level 2 Level 3 Total Assets: Cash equivalents: Money market funds $ — $ 29,879 $ — $ 29,879 Marketable securities: United States treasury notes — 44,534 — 44,534 Agency bonds — 29,746 — 29,746 Total $ — $ 104,159 $ — $ 104,159 |
Accrued Expenses (Tables)
Accrued Expenses (Tables) | 6 Months Ended |
Jun. 30, 2016 | |
Payables and Accruals [Abstract] | |
Schedule of Accrued Expenses | Accrued expenses consisted of the following: June 30, 2016 December 31, 2015 Accrued payroll and related expenses $ 1,003 $ 1,582 Accrued professional fees 577 471 Accrued research and development expenses 193 430 Accrued insurance — 389 Accrued other 569 507 $ 2,342 $ 3,379 |
Notes Payable (Tables)
Notes Payable (Tables) | 6 Months Ended |
Jun. 30, 2016 | |
Debt Disclosure [Abstract] | |
Schedule of Annual Repayment Requirements for Credit Facility | As of June 30, 2016, the annual repayment requirements for the Amended 2014 Credit Facility, inclusive of the final payment of $585 due at expiration, were as follows: Year Ending December 31, Principal Interest and Final Payment Total 2016 $ — $ 656 $ 656 2017 5,200 1,105 6,305 2018 5,200 670 5,870 2019 5,200 820 6,020 $ 15,600 $ 3,251 $ 18,851 |
Stock-Based Awards (Tables)
Stock-Based Awards (Tables) | 6 Months Ended |
Jun. 30, 2016 | |
Disclosure of Compensation Related Costs, Share-based Payments [Abstract] | |
Schedule of Stock-Based Compensation Expense Related to Stock Options and Restricted Common Stock | The Company recorded stock-based compensation expense related to stock options and restricted common stock in the following expense categories of its statements of operations: Three Months Ended June 30, Six Months Ended June 30. 2016 2015 2016 2015 Research and development $ 522 $ 415 $ 975 $ 717 Selling and marketing 128 95 235 158 General and administrative 865 642 1,654 1,198 $ 1,515 $ 1,152 $ 2,864 $ 2,073 |
Commitments and Contingencies (
Commitments and Contingencies (Tables) | 6 Months Ended |
Jun. 30, 2016 | |
Expires in June 2017 and 2018 [Member] | |
Summary of Future Minimum Lease Payments for Operating Leases | Future minimum lease payments as of June 30, 2016 for its operating leases that expire in June 2017 and June 2018 are as follows: Years Ending December 31, 2016 $ 414 2017 676 2018 262 Total $ 1,352 |
Expires in July 2027 [Member] | |
Summary of Future Minimum Lease Payments for Operating Leases | Future minimum lease payments as of June 30, 2016 for its operating lease expiring in July 2027 are as follows: Years Ending December 31, 2016 $ — 2017 486 2018 1,199 2019 1,235 2020 1,270 Thereafter 9,245 Total $ 13,435 |
Summary of Significant Accoun25
Summary of Significant Accounting Policies - Summary of Marketable Securities by Security Type (Detail) - USD ($) $ in Thousands | Jun. 30, 2016 | Dec. 31, 2015 |
Schedule of Available-for-sale Securities [Line Items] | ||
Amortized Cost | $ 35,707 | $ 74,348 |
Gross Unrealized Gains | 10 | |
Gross Unrealized Losses | (68) | |
Estimated Fair Value | 35,717 | 74,280 |
United States Treasury Notes [Member] | ||
Schedule of Available-for-sale Securities [Line Items] | ||
Amortized Cost | 33,518 | 44,587 |
Gross Unrealized Gains | 10 | |
Gross Unrealized Losses | (53) | |
Estimated Fair Value | 33,528 | 44,534 |
Agency Bonds [Member] | ||
Schedule of Available-for-sale Securities [Line Items] | ||
Amortized Cost | 2,189 | 29,761 |
Gross Unrealized Losses | (15) | |
Estimated Fair Value | $ 2,189 | $ 29,746 |
Summary of Significant Accoun26
Summary of Significant Accounting Policies - Additional Information (Detail) - USD ($) $ in Thousands | Jun. 30, 2016 | Jun. 30, 2016 | Dec. 31, 2015 |
Summary Of Significant Accounting Policies [Line Items] | |||
Maturity period for marketable securities classified as available-for-sale | 1 year | 1 year | |
Certificate of deposit | $ 1,728 | $ 1,728 | $ 228 |
Additional certificate of deposit | 1,500 | ||
Certificates of Deposit [Member] | |||
Summary Of Significant Accounting Policies [Line Items] | |||
Certificate of deposit | 1,728 | $ 1,728 | $ 228 |
Additional certificate of deposit | $ 1,500 |
Summary of Significant Accoun27
Summary of Significant Accounting Policies - Schedule of Antidilutive Securities, Excluded from Computation of Diluted Net Loss per Share (Detail) - shares | 6 Months Ended | |
Jun. 30, 2016 | Jun. 30, 2015 | |
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] | ||
Total options, warrants and restricted stock | 3,027,829 | 2,131,546 |
Options to Purchase Common Stock [Member] | ||
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] | ||
Total options, warrants and restricted stock | 3,008,890 | 2,098,388 |
Non-vested Restricted Stock [Member] | ||
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] | ||
Total options, warrants and restricted stock | 14,219 | |
Warrants for the Purchase of Common Stock [Member] | ||
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] | ||
Total options, warrants and restricted stock | 18,939 | 18,939 |
Fair Value of Financial Asset28
Fair Value of Financial Assets and Liabilities - Schedule of Assets and Liabilities Measured at Fair Value on Recurring Basis (Detail) - USD ($) $ in Thousands | Jun. 30, 2016 | Dec. 31, 2015 |
Assets: | ||
Marketable securities | $ 35,717 | $ 74,280 |
Recurring Basis [Member] | ||
Assets: | ||
Total assets at fair value | 83,522 | 104,159 |
Recurring Basis [Member] | United States Treasury Notes [Member] | ||
Assets: | ||
Marketable securities | 33,528 | 44,534 |
Recurring Basis [Member] | Agency Bonds [Member] | ||
Assets: | ||
Marketable securities | 2,189 | 29,746 |
Money Market Funds [Member] | Recurring Basis [Member] | ||
Assets: | ||
Cash equivalents | 47,805 | 29,879 |
Level 2 [Member] | Recurring Basis [Member] | ||
Assets: | ||
Total assets at fair value | 83,522 | 104,159 |
Level 2 [Member] | Recurring Basis [Member] | United States Treasury Notes [Member] | ||
Assets: | ||
Marketable securities | 33,528 | 44,534 |
Level 2 [Member] | Recurring Basis [Member] | Agency Bonds [Member] | ||
Assets: | ||
Marketable securities | 2,189 | 29,746 |
Level 2 [Member] | Money Market Funds [Member] | Recurring Basis [Member] | ||
Assets: | ||
Cash equivalents | $ 47,805 | $ 29,879 |
Accrued Expenses - Schedule of
Accrued Expenses - Schedule of Accrued Expenses (Detail) - USD ($) $ in Thousands | Jun. 30, 2016 | Dec. 31, 2015 |
Payables and Accruals [Abstract] | ||
Accrued payroll and related expenses | $ 1,003 | $ 1,582 |
Accrued professional fees | 577 | 471 |
Accrued research and development expenses | 193 | 430 |
Accrued insurance | 389 | |
Accrued other | 569 | 507 |
Total | $ 2,342 | $ 3,379 |
Income Taxes - Additional Infor
Income Taxes - Additional Information (Detail) - USD ($) | 6 Months Ended | |
Jun. 30, 2016 | Dec. 31, 2015 | |
Income Tax Disclosure [Abstract] | ||
Unrecognized tax benefits | $ 0 | $ 0 |
Accrued interest or tax penalties related to income taxes | $ 0 | $ 0 |
Income tax examination, year under examination | 2,012 |
Feasibility Agreements - Additi
Feasibility Agreements - Additional Information (Detail) - USD ($) | 1 Months Ended | 3 Months Ended | 6 Months Ended | ||||
Jan. 31, 2015 | Oct. 31, 2014 | Jun. 30, 2016 | Jun. 30, 2015 | Jun. 30, 2016 | Jun. 30, 2015 | Dec. 31, 2015 | |
Collaborative Arrangements and Non-collaborative Arrangement Transactions [Line Items] | |||||||
Revenue recognized | $ 125,000 | $ 42,000 | $ 313,000 | ||||
Deferred revenue | $ 42,000 | ||||||
Feasibility Agreement [Member] | Biotechnology [Member] | |||||||
Collaborative Arrangements and Non-collaborative Arrangement Transactions [Line Items] | |||||||
Potential agreement revenue | $ 700,000 | ||||||
Non-Refundable revenue entitled to receive on milestone achievement | 250,000 | ||||||
Maximum revenue that could be recognized | $ 450,000 | ||||||
Payment received on milestone achievement | $ 250,000 | ||||||
Revenue recognized | $ 0 | $ 125,000 | 42,000 | $ 313,000 | |||
Deferred revenue | 0 | 0 | $ 42,000 | ||||
Non-Refundable revenue | $ 500,000 | $ 500,000 |
Notes Payable - Additional Info
Notes Payable - Additional Information (Detail) - USD ($) | Jun. 30, 2016 | Dec. 31, 2015 |
2014 Credit Facility [Member] | ||
Line of Credit Facility [Line Items] | ||
Additional final payment | $ 585,000 | $ 585,000 |
Amended 2014 Credit Facility [Member] | ||
Line of Credit Facility [Line Items] | ||
Outstanding borrowings, Interest rate | 8.25% | 8.25% |
Credit facility, Final payment percent of amounts drawn under the facility | 3.75% | 3.75% |
Outstanding borrowings, Effective annual interest rate | 10.60% | 10.60% |
Borrowing capacity under the agreement | $ 15,600,000 | $ 15,600,000 |
Notes Payable - Schedule of Ann
Notes Payable - Schedule of Annual Repayment Requirements for Credit Facility (Detail) - 2014 Credit Facility [Member] $ in Thousands | 6 Months Ended |
Jun. 30, 2016USD ($) | |
Line of Credit Facility [Line Items] | |
Credit Facility, Principal | $ 15,600 |
Credit Facility, Interest and Final Payment | 3,251 |
Credit Facility, Total | 18,851 |
2016 [Member] | |
Line of Credit Facility [Line Items] | |
Credit Facility, Interest and Final Payment | 656 |
Credit Facility, Total | 656 |
2017 [Member] | |
Line of Credit Facility [Line Items] | |
Credit Facility, Principal | 5,200 |
Credit Facility, Interest and Final Payment | 1,105 |
Credit Facility, Total | 6,305 |
2018 [Member] | |
Line of Credit Facility [Line Items] | |
Credit Facility, Principal | 5,200 |
Credit Facility, Interest and Final Payment | 670 |
Credit Facility, Total | 5,870 |
2019 [Member] | |
Line of Credit Facility [Line Items] | |
Credit Facility, Principal | 5,200 |
Credit Facility, Interest and Final Payment | 820 |
Credit Facility, Total | $ 6,020 |
Common Stock and Preferred St34
Common Stock and Preferred Stock - Additional Information (Detail) - USD ($) $ / shares in Units, $ in Thousands | Aug. 19, 2014 | Jul. 30, 2014 | Jun. 30, 2015 | Jun. 30, 2015 | Jun. 30, 2016 | Dec. 31, 2015 |
Class of Stock [Line Items] | ||||||
Proceeds from issuance of shares | $ 65,646 | |||||
Common stock, shares authorized | 100,000,000 | 100,000,000 | ||||
Preferred stock, shares authorized | 5,000,000 | 5,000,000 | ||||
Preferred stock, par value | $ 0.0001 | $ 0.0001 | ||||
Common Stock [Member] | ||||||
Class of Stock [Line Items] | ||||||
Common stock, shares authorized | 100,000,000 | |||||
Preferred Stock [Member] | ||||||
Class of Stock [Line Items] | ||||||
Preferred stock, shares authorized | 5,000,000 | |||||
Preferred stock, par value | $ 0.0001 | |||||
IPO [Member] | Common Stock [Member] | ||||||
Class of Stock [Line Items] | ||||||
Number of shares issued | 5,000,000 | |||||
Common stock, price per share | $ 13 | |||||
Proceeds from issuance of shares | $ 57,337 | |||||
Number of common shares issued on conversion of redeemable convertible preferred stock | 12,440,205 | |||||
Over-allotment Option [Member] | Common Stock [Member] | ||||||
Class of Stock [Line Items] | ||||||
Number of shares issued | 750,000 | |||||
Common stock, price per share | $ 13 | |||||
Proceeds from issuance of shares | $ 9,068 | |||||
Follow-on Offering [Member] | Common Stock [Member] | ||||||
Class of Stock [Line Items] | ||||||
Number of shares issued | 4,600,000 | |||||
Common stock, price per share | $ 22 | $ 22 | ||||
Proceeds from issuance of shares | $ 65,612 | |||||
Number of shares offered by company | 3,200,000 | |||||
Number of shares offered by stockholders | 1,400,000 |
Warrants - Additional Informati
Warrants - Additional Information (Detail) - $ / shares | 6 Months Ended | |
Jun. 30, 2016 | Jun. 30, 2015 | |
Class of Warrant or Right [Line Items] | ||
Warrant expiration date | Apr. 17, 2021 | |
Warrants exercised | 0 | |
Warrant [Member] | Common Stock [Member] | ||
Class of Warrant or Right [Line Items] | ||
Number of shares issued | 54,010 | |
Warrants for Common Stock [Member] | ||
Class of Warrant or Right [Line Items] | ||
Number of shares callable by warrants | 18,939 | |
Shares covered under warrants exercised | 70,769 | |
Warrants for Common Stock [Member] | Weighted Average [Member] | ||
Class of Warrant or Right [Line Items] | ||
Weighted average exercise price to purchase common stock | $ 7.92 |
Stock-Based Awards - Additional
Stock-Based Awards - Additional Information (Detail) - USD ($) $ in Thousands | 6 Months Ended | ||
Jun. 30, 2016 | Jun. 30, 2015 | Jan. 01, 2016 | |
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||
Proceeds from issuance of common stock | $ 65,646 | ||
Unrecognized stock-based compensation cost | $ 12,604 | ||
Weighted average period of unrecognized stock-based compensation cost expected to be recognized | 2 years 6 months 11 days | ||
Unvested service-based stock options held by nonemployees | 9,156 | ||
2014 Stock Incentive Plan [Member] | Common Stock [Member] | |||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||
Number of shares of common stock available for issuance | 1,493,039 | ||
Increased number of shares of common stock reserved for issuance | 990,012 | ||
2014 Employee Stock Purchase Plan [Member] | Common Stock [Member] | |||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||
Number of shares of common stock available for issuance | 299,342 | ||
Increased number of shares of common stock reserved for issuance | 123,752 | ||
Proceeds from issuance of common stock | $ 128 | ||
Issuance of common stock in connection with employee stock purchase plan, shares | 30,501 |
Stock-Based Awards - Schedule o
Stock-Based Awards - Schedule of Stock-Based Compensation Expense Related to Stock Options and Restricted Common Stock (Detail) - USD ($) $ in Thousands | 3 Months Ended | 6 Months Ended | ||
Jun. 30, 2016 | Jun. 30, 2015 | Jun. 30, 2016 | Jun. 30, 2015 | |
Share-based Compensation Arrangement by Share-based Payment Award, Compensation Cost [Line Items] | ||||
Stock-based compensation expense | $ 1,515 | $ 1,152 | $ 2,864 | $ 2,073 |
Research and Development Expense [Member] | ||||
Share-based Compensation Arrangement by Share-based Payment Award, Compensation Cost [Line Items] | ||||
Stock-based compensation expense | 522 | 415 | 975 | 717 |
Selling and Marketing Expense [Member] | ||||
Share-based Compensation Arrangement by Share-based Payment Award, Compensation Cost [Line Items] | ||||
Stock-based compensation expense | 128 | 95 | 235 | 158 |
General and Administrative Expense [Member] | ||||
Share-based Compensation Arrangement by Share-based Payment Award, Compensation Cost [Line Items] | ||||
Stock-based compensation expense | $ 865 | $ 642 | $ 1,654 | $ 1,198 |
Commitments and Contingencies -
Commitments and Contingencies - Additional Information (Detail) $ in Thousands | Jun. 17, 2016USD ($)ft² | Jun. 30, 2016USD ($) | Jun. 30, 2015USD ($) | Jun. 30, 2016USD ($) | Jun. 30, 2015USD ($) |
Commitments And Contingencies [Line Items] | |||||
Non-cancelable operating leases expiration | June 2017, June 2018 and July 2027 | ||||
Rental expense | $ 194 | $ 195 | $ 388 | $ 390 | |
Area covered under lease | ft² | 70,712 | ||||
Lease term commencement date | Feb. 1, 2017 | ||||
Lease term expiration date | Jul. 31, 2027 | ||||
Initial annual base rent of leased space | $ 1,200 | ||||
Letter of Credit [Member] | |||||
Commitments And Contingencies [Line Items] | |||||
Letter of credit for restricted cash | 1,500 | ||||
Maximum [Member] | |||||
Commitments And Contingencies [Line Items] | |||||
Construction allowance under lease agreement | $ 2,800 | ||||
Incept [Member] | |||||
Commitments And Contingencies [Line Items] | |||||
Royalties paid related to product sales | $ 67 |
Commitments and Contingencies39
Commitments and Contingencies - Summary of Future Minimum Lease Payments for Operating Leases (Detail) $ in Thousands | Jun. 30, 2016USD ($) |
Expires in June 2017 and 2018 [Member] | |
Operating Leased Assets [Line Items] | |
2,016 | $ 414 |
2,017 | 676 |
2,018 | 262 |
Total | 1,352 |
Expires in July 2027 [Member] | |
Operating Leased Assets [Line Items] | |
2,017 | 486 |
2,018 | 1,199 |
2,019 | 1,235 |
2,020 | 1,270 |
Thereafter | 9,245 |
Total | $ 13,435 |
Related Party Transactions - Ad
Related Party Transactions - Additional Information (Detail) - Chief Executive Officer [Member] - USD ($) $ in Thousands | 1 Months Ended | |
Apr. 30, 2014 | Apr. 01, 2016 | |
Related Party Transaction [Line Items] | ||
Number of Shares Granted | 28,437 | |
Base salary | $ 250 | |
Due from stockholder | $ 250 |