Document and Entity Information
Document and Entity Information - shares | 9 Months Ended | |
Sep. 30, 2015 | Oct. 30, 2015 | |
Document And Entity Information [Abstract] | ||
Document Type | 10-Q | |
Amendment Flag | false | |
Document Period End Date | Sep. 30, 2015 | |
Document Fiscal Year Focus | 2,015 | |
Document Fiscal Period Focus | Q3 | |
Trading Symbol | OTIC | |
Entity Registrant Name | Otonomy, Inc. | |
Entity Central Index Key | 1,493,566 | |
Current Fiscal Year End Date | --12-31 | |
Entity Filer Category | Non-accelerated Filer | |
Entity Common Stock, Shares Outstanding | 24,238,269 |
Condensed Balance Sheets
Condensed Balance Sheets - USD ($) $ in Thousands | Sep. 30, 2015 | Dec. 31, 2014 |
Current assets: | ||
Cash and cash equivalents | $ 176,602 | $ 139,810 |
Short-term investments | 22,587 | 16,223 |
Prepaid and other current assets | 5,260 | 1,669 |
Total current assets | 204,449 | 157,702 |
Restricted cash | 695 | 0 |
Property and equipment, net | 2,851 | 1,257 |
Other long-term assets | 489 | 205 |
Total assets | 208,484 | 159,164 |
Current liabilities: | ||
Accounts payable | 2,094 | 1,710 |
Accrued expenses | 4,196 | 3,046 |
Accrued compensation | 2,316 | 575 |
Current portion of deferred rent | 97 | 86 |
Total current liabilities | 8,703 | 5,417 |
Deferred rent, net of current portion | 164 | 134 |
Total liabilities | $ 8,867 | $ 5,551 |
Commitments and Contingencies | ||
Stockholders' equity: | ||
Preferred stock, $0.001 par value, 10,000,000 shares authorized at September 30, 2015 and December 31, 2014; no shares issued or outstanding at September 30, 2015 and December 31, 2014 | $ 0 | $ 0 |
Common stock, $0.001 par value; 200,000,000 shares authorized at September 30, 2015 and December 31, 2014; 24,235,769 and 21,173,270 shares issued and outstanding at September 30, 2015 and December 31, 2014, respectively | 24 | 21 |
Additional paid-in capital | 342,588 | 256,061 |
Accumulated deficit | (142,995) | (102,469) |
Total stockholders' equity | 199,617 | 153,613 |
Total liabilities and stockholders' equity | $ 208,484 | $ 159,164 |
Condensed Balance Sheets (Paren
Condensed Balance Sheets (Parenthetical) - $ / shares | Sep. 30, 2015 | Dec. 31, 2014 |
Statement of Financial Position [Abstract] | ||
Preferred stock, par value | $ 0.001 | $ 0.001 |
Preferred stock, shares authorized | 10,000,000 | 10,000,000 |
Preferred stock, shares issued | 0 | 0 |
Preferred stock, shares outstanding | 0 | 0 |
Common stock, par value | $ 0.001 | $ 0.001 |
Common stock, shares authorized | 200,000,000 | 200,000,000 |
Common stock, shares Issued | 24,235,769 | 21,173,270 |
Common stock, Shares outstanding | 24,235,769 | 21,173,270 |
Condensed Statements of Operati
Condensed Statements of Operations and Comprehensive Loss - USD ($) $ in Thousands | 3 Months Ended | 9 Months Ended | ||
Sep. 30, 2015 | Sep. 30, 2014 | Sep. 30, 2015 | Sep. 30, 2014 | |
Operating expenses: | ||||
Research and development | $ 9,589 | $ 7,361 | $ 25,485 | $ 24,616 |
General and administrative | 6,492 | 2,040 | 15,345 | 5,169 |
Total operating expenses | 16,081 | 9,401 | 40,830 | 29,785 |
Loss from operations | (16,081) | (9,401) | (40,830) | (29,785) |
Other (expense) income: | ||||
Interest income | 116 | 36 | 305 | 45 |
Interest expense | 0 | (31) | 0 | (39) |
Change in fair value of convertible preferred stock warrant liability | 0 | (2,632) | 0 | (3,300) |
Other expense | 0 | (3) | (1) | (4) |
Total other (expense) income | 116 | (2,630) | 304 | (3,298) |
Net loss and comprehensive loss | (15,965) | (12,031) | (40,526) | (33,083) |
Accretion to redemption value of convertible preferred stock | 0 | (7) | 0 | (35) |
Net loss attributable to common stockholders | $ (15,965) | $ (12,038) | $ (40,526) | $ (33,118) |
Net loss per share attributable to common stockholders, basic and diluted | $ (0.66) | $ (1.23) | $ (1.70) | $ (9.83) |
Weighted-average shares used to compute net loss per share attributable to common stockholders, basic and diluted | 24,197,160 | 9,823,690 | 23,847,988 | 3,369,437 |
Condensed Statements of Cash Fl
Condensed Statements of Cash Flows - USD ($) $ in Thousands | 9 Months Ended | |
Sep. 30, 2015 | Sep. 30, 2014 | |
Cash flows from operating activities: | ||
Net loss | $ (40,526) | $ (33,083) |
Adjustments to reconcile net loss to net cash used in operating activities: | ||
Depreciation and amortization | 212 | 152 |
Stock-based compensation | 5,321 | 895 |
Non-cash license fee | 447 | 0 |
Non-cash interest expense | 0 | 39 |
Change in fair value of convertible preferred stock warrant liability | 0 | 3,300 |
Amortization of discount or premium on short-term investments | 15 | 0 |
Deferred rent | 41 | (54) |
Changes in operating assets and liabilities: | ||
Prepaid and other assets | (3,875) | (542) |
Accounts payable | (348) | (814) |
Accrued expenses | 948 | 2,076 |
Accrued compensation | 1,741 | 1,010 |
Net cash used in operating activities | (36,024) | (27,021) |
Cash flows from investing activities: | ||
Purchases of short-term investments | (27,340) | 0 |
Maturities of short-term investments | 20,961 | 0 |
Purchases of property and equipment | (872) | (402) |
(Increase) decrease in restricted cash | (695) | 75 |
Net cash used in investing activities | (7,946) | (327) |
Cash flows from financing activities: | ||
Proceeds from issuance of convertible preferred stock, net of issuance costs | 0 | 49,239 |
Proceeds from issuance of common stock, net of transaction costs | 80,358 | 104,681 |
Proceeds from exercise of stock options, net of early exercise liability | 389 | 98 |
Net cash provided by financing activities | 80,762 | 155,219 |
Net change in cash | 36,792 | 127,871 |
Cash and cash equivalents at beginning of period | 139,810 | 37,284 |
Cash and cash equivalents at end of period | 176,602 | 165,155 |
Supplemental disclosure of non-cash investing and financing activities: | ||
Purchase of property and equipment in accounts payable and accrued expenses | 934 | 19 |
Deferred public offering costs in accounts payable and accrued expenses | 0 | 555 |
Preferred Stock Warrants [Member] | ||
Cash flows from financing activities: | ||
Proceeds from exercise of stock warrants | 0 | 1,201 |
Common Stock Warrants [Member] | ||
Cash flows from financing activities: | ||
Proceeds from exercise of stock warrants | $ 15 | $ 0 |
Description of Business and Bas
Description of Business and Basis of Presentation | 9 Months Ended |
Sep. 30, 2015 | |
Accounting Policies [Abstract] | |
Description of Business and Basis of Presentation | 1. Description of Business and Basis of Presentation Description of Business Otonomy, Inc. (the “Company”) was incorporated in the state of Delaware on May 6, 2008. The Company is a clinical-stage biopharmaceutical company focused on the development and commercialization of innovative therapeutics for the treatment of diseases and disorders of the ear. The Company’s proprietary technology is designed to deliver drug that is retained in the ear for an extended period of time following a single local administration. Utilizing this technology, the Company has advanced three product candidates into development. OTIPRIO TM TM On July 31, 2014, the Company filed an amendment to its amended and restated certificate of incorporation, affecting a one-for-35.16 reverse stock split of its outstanding common and convertible preferred stock, which was approved by the Company’s board of directors on July 29, 2014. The accompanying condensed financial statements and notes to the condensed financial statements give retroactive effect to the reverse split for all periods presented. In August 2014, the Company completed its initial public offering (the “IPO”) of 7,187,500 shares of common stock, which includes the exercise in full by the underwriters of their option to purchase up to 937,500 shares of common stock, at an offering price of $16.00 per share. Proceeds from the IPO were $104.1 million, net of underwriting discounts and commissions and offering-related transaction costs. In January 2015, the Company completed a follow-on public offering of 2,932,500 shares of its common stock, which includes the exercise in full by the underwriters of their option to purchase 382,500 shares of common stock, at an offering price of $29.25 per share. Proceeds from the follow-on public offering were approximately $80.0 million, net of underwriting discounts, commissions and offering-related transaction costs. Basis of Presentation As of September 30, 2015, the Company has devoted substantially all of its efforts to product development, raising capital, and building infrastructure and has not realized revenues from its planned principal operations. The accompanying condensed financial statements have been prepared assuming the Company will continue as a going concern, which contemplates the realization of assets and the satisfaction of liabilities in the normal course of business. The Company has incurred operating losses and negative cash flows from operating activities since inception. As of September 30, 2015, the Company had cash, cash equivalents and short-term investments of $199.2 million and an accumulated deficit of $143.0 million. The Company anticipates that it will continue to incur net losses into the foreseeable future as it: (i) continues the development and begins commercialization of its product candidates OTIPRIO, OTO-104 and OTO-311; (ii) works to develop additional product candidates through research and development programs; and (iii) expands its corporate infrastructure. The Company plans to continue to fund its losses from operations and capital funding needs through future debt and/or equity financings or other sources, such as potential collaboration agreements. If the Company is not able to secure adequate additional funding, the Company may be forced to make reductions in spending, extend payment terms with suppliers, liquidate assets where possible, and/or suspend or curtail planned programs. Any of these actions could materially harm the Company’s business, results of operations, and future prospects. Unaudited Interim Financial Information The accompanying interim condensed financial statements are unaudited. These unaudited interim condensed financial statements have been prepared in accordance with accounting principles generally accepted in the United States of America (GAAP) and following the requirements of the United States Securities and Exchange Commission (SEC) for interim reporting. As permitted under those rules, certain footnotes or other financial information that are normally required by GAAP can be condensed or omitted. In management’s opinion, the unaudited interim condensed financial statements have been prepared on the same basis as the audited financial statements and include all adjustments, which include only normal recurring adjustments, necessary for the fair presentation of the Company’s financial position, its results of operations and its cash flows for the periods presented. These statements do not include all disclosures required by GAAP and should be read in conjunction with the Company’s audited financial statements and accompanying notes for the year ended December 31, 2014 included in the Company’s Form 10-K. The results presented in these unaudited condensed financial statements are not necessarily indicative of the results expected for the full fiscal year or any other interim period or any future year or period. |
Summary of Significant Accounti
Summary of Significant Accounting Policies | 9 Months Ended |
Sep. 30, 2015 | |
Accounting Policies [Abstract] | |
Summary of Significant Accounting Policies | 2. Summary of Significant Accounting Policies Use of Estimates The accompanying condensed financial statements have been prepared in accordance with GAAP. 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 and disclosure of contingent assets and liabilities at the date of the financial statements and the reported amounts of expense during the reporting period. The most significant estimates in the Company’s financial statements relate to clinical trial accruals. Although these estimates are based on the Company’s knowledge of current events and actions it may undertake in the future, actual results may ultimately materially differ from these estimates and assumptions. Segment Reporting Operating segments are identified as components of an enterprise about which separate discrete financial information is available for evaluation by the chief operating decision-maker in making decisions regarding resource allocation and assessing performance. The Company views its operations and manages its business in one operating segment. Concentrations of Credit Risk Financial instruments that potentially subject the Company to significant concentrations of credit risk consist primarily of cash, cash equivalents and short-term investments. The Company maintains deposits in federally insured financial institutions in excess of federally insured limits. The Company has not experienced any losses in such accounts and believes it is not exposed to significant risk on its cash balances due to the financial position of the depository institutions in which those deposits are held. Additionally, the Company established guidelines regarding approved investments and maturities of investments, which are designed to maintain safety and liquidity. Cash and Cash Equivalents Cash and cash equivalents consist of cash and highly liquid investments with original maturities of three months or less at the date of purchase. The carrying amounts approximate fair value due to the short maturities of these instruments. Cash and cash equivalents include cash in readily available checking, savings and money market accounts, as well as certificates of deposit. Short-Term Investments The Company carries short-term investments classified as available-for-sale at fair value as determined by prices for identical or similar securities at the balance sheet date. Short-term investments consist of both Level 1 and Level 2 financial instruments in the fair value hierarchy (see Note 6). Realized gains or losses of available-for-sale securities are determined using the specific identification method and net realized gains and losses are included in interest income. The Company periodically reviews available-for-sale securities for other-than temporary declines in fair value below the cost basis, and whenever events or changes in circumstances indicate that the carrying amount of an asset may not be recoverable. Fair Value of Financial Instruments The carrying value of the Company’s cash and cash equivalents, short-term investments, prepaid expenses and other current assets, other assets, accounts payable, accrued liabilities, and accrued compensation approximate fair value due to the short-term nature of these items. Restricted Cash The Company’s restricted cash consists of cash maintained in a separate deposit account to secure a letter of credit issued by a bank to the landlord under a lease agreement for construction of the Company’s new corporate headquarters (see Note 5). The Company has classified the restricted cash as noncurrent on the condensed balance sheet. Property and Equipment Property and equipment generally consist of manufacturing equipment, furniture and fixtures, computers, and scientific and office equipment and are recorded at cost and depreciated using the straight-line method over the estimated useful lives of the assets (generally three to ten years). Leasehold improvements are stated at cost and are depreciated on a straight-line basis over the lesser of the remaining term of the related lease or the estimated useful lives of the assets. Repairs and maintenance costs are charged to expense as incurred. Impairment of Long-Lived Assets The Company assesses the value of its long-lived assets, which consist of property and equipment, for impairment on an annual basis and whenever events or changes in circumstances and the undiscounted cash flows generated by those assets indicate that the carrying amount of such assets may not be recoverable. While the Company’s current and historical operating losses and negative cash flows are indicators of impairment, management believes that future cash flows to be received support the carrying value of its long-lived assets and, accordingly, has not recognized any impairment losses through September 30, 2015. Clinical Trial Expense Accruals As part of the process of preparing the Company’s condensed financial statements, the Company is required to estimate expenses resulting from the Company’s obligations under contracts with vendors, clinical research organizations and consultants and under clinical site agreements in connection with conducting clinical trials. The financial terms of these contracts are subject to negotiations, which vary from contract to contract and may result in payment flows that do not match the periods over which materials or services are provided under such contracts. The Company’s objective is to reflect the appropriate clinical trial expenses in its financial statements by recording those expenses in the period in which services are performed and efforts are expended. The Company accounts for these expenses according to the progress of the trial as measured by patient progression and the timing of various aspects of the trial. The Company determines accrual estimates through financial models taking into account discussion with applicable personnel and outside service providers as to the progress or state of its trials. During the course of a clinical trial, the Company adjusts its clinical expense if actual results differ from its estimates. Research and Development Research and development expenses include the costs associated with the Company’s research and development activities, including salaries, benefits and occupancy costs. Also included in research and development expenses are third-party costs incurred in conjunction with contract manufacturing for the Company’s research and development programs and clinical trials, including the cost of clinical trial drug supply, costs incurred by contract research organizations and regulatory expenses. Research and development costs are expensed as incurred. Patent Expenses The Company expenses all costs as incurred in connection with patent applications (including direct application fees, and the legal and consulting expenses related to making such applications) and such costs are included in general and administrative expenses in the accompanying condensed statements of operations. Convertible Preferred Stock Warrants Prior to the Company’s IPO in August 2014, warrants exercisable for shares of the Company’s Series A and Series C convertible preferred stock were classified as liabilities based upon the characteristics and provisions of each instrument. Convertible preferred stock warrants were classified as derivative liabilities and were recorded at their fair value on the date of issuance. At each reporting date the convertible preferred stock warrants were revalued, with fair value changes recognized as increases in or decreases to the change in fair value of convertible preferred stock warrant liability in the statements of operations. In connection with the IPO, all of the Company’s outstanding warrants to purchase convertible preferred stock were either (i) exercised and the underlying shares of preferred stock were automatically converted into shares of common stock or (ii) converted into warrants to purchase common stock. Prior to the exercise and conversion of the warrants to purchase convertible preferred stock, the Company performed the final revaluation of the warrant liability upon the closing of the IPO in August 2014 and recorded the $2.6 million increase in fair value to change in fair value of convertible preferred stock warrant liability in the statements of operations. The warrant liability was then reclassified to additional paid-in capital in the balance sheets. Stock-Based Compensation The Company accounts for stock-based compensation expense related to stock options and employee stock purchase plan (ESPP) rights by estimating the fair value on the date of grant using the Black-Scholes-Merton option pricing model net of estimated forfeitures. For awards subject to time-based vesting conditions, stock-based compensation expense is recognized using the straight-line method. The Company accounts for stock options granted to non-employees, including members of the scientific advisory board, using the fair value approach. Stock options granted to non-employees may be subject to periodic revaluation over their vesting terms with the related expense being recognized as research and development and/or general and administrative expense in the accompanying condensed statements of operations. Income Taxes The accounting guidance for uncertainty in income taxes prescribes a recognition threshold and measurement attribute criteria for the financial statement recognition and measurement of tax positions taken or expected to be taken in a tax return. For those benefits to be recognized, a tax position must be more likely than not to be sustained upon examination by taxing authorities based on the technical merits of the position. The Company uses the liability method of accounting for income taxes. Under this method, deferred tax assets and liabilities are determined based on the difference between the financial reporting and the tax reporting basis of assets and liabilities and are measured using the enacted tax rates and laws that are expected to be in effect when the differences are expected to reverse. The Company provides a valuation allowance against net deferred tax assets unless, based upon the available evidence, it is more likely than not that the deferred tax assets will be realized. When the Company establishes or reduces the valuation allowance against its deferred tax assets, its provision for income taxes will increase or decrease, respectively, in the period such determination is made. Comprehensive Loss Comprehensive loss is defined as the change in equity during a period from transactions and other events and/or circumstances from non-owner sources. For all periods presented, comprehensive loss is equal to net loss. Net Loss Per Share Basic net loss per common share is calculated by dividing the net loss attributable to common stockholders by the weighted-average number of common shares outstanding during the period, without consideration for potentially dilutive securities. Diluted net loss per share is computed by dividing the net loss attributable to common stockholders by the weighted-average number of common shares and potentially dilutive securities outstanding for the period determined using the treasury-stock and if-converted methods. For purposes of the diluted net loss per share calculation, potentially dilutive securities are excluded from the calculation of diluted net loss per share because their effect would be anti-dilutive and therefore, basic and diluted net loss per share were the same for all periods presented. Potentially dilutive securities excluded from the calculation of diluted net loss per share attributable to common stockholders are as follows (in common stock equivalent shares): Three and Nine Months Ended September 30, 2015 2014 Warrants to purchase common stock 141,060 142,113 Unvested restricted common stock subject to repurchase 5,629 16,294 Options to purchase common stock 3,354,274 2,058,910 3,500,963 2,217,317 |
Available-for-Sale Securities
Available-for-Sale Securities | 9 Months Ended |
Sep. 30, 2015 | |
Investments, Debt and Equity Securities [Abstract] | |
Available-for-Sale Securities | 3. Available-for-Sale Securities The Company invests in available-for-sale securities consisting of money market funds and certificates of deposit. Available-for-sale securities are classified as part of either cash and cash equivalents or short-term investments in the condensed balance sheets. Available-for-sale securities with maturities of three months or less from the date of purchase have been classified as cash equivalents, and were $12.5 million and $18.8 million as of September 30, 2015 and December 31, 2014, respectively. Available-for-sale securities with maturities of more than three months from the date of purchase have been classified as short-term investments, and were $22.6 million and $16.2 million as of September 30, 2015 and December 31, 2014, respectively. There have been no unrealized gains or losses related to the Company’s short-term investments. The Company determined that there were no other-than-temporary declines in the value of any available-for-sale securities as of September 30, 2015. All of the Company’s available-for-sale investment securities mature within one year. The Company obtains the fair value of its available-for-sale securities from the custodian bank or from a professional pricing service. |
Balance Sheet Details
Balance Sheet Details | 9 Months Ended |
Sep. 30, 2015 | |
Organization, Consolidation and Presentation of Financial Statements [Abstract] | |
Balance Sheet Details | 4. Balance Sheet Details Prepaid and Other Current Assets Prepaid and other current assets are comprised of the following (in thousands): September 30, December 31, 2015 2014 Prepaid clinical trial costs $ 1,485 $ 843 FDA deposit (1) 2,335 — Other 1,440 826 Total $ 5,260 $ 1,669 (1) In February 2015, in accordance with the Federal Food, Drug, and Cosmetic Act (the “Act”), the Company paid an application fee of $2.3 million to the FDA for its OTIPRIO NDA submission. Prior to the submission of the OTIPRIO NDA, the Company filed a request with the FDA to grant a waiver and refund of the application fee under the small business waiver provision of the Act. During October 2015, the FDA granted the Company’s request for a waiver and refunded the application fee in full. Property and Equipment, Net Property and equipment, net consists of the following (in thousands): September 30, December 31, 2015 2014 Laboratory equipment $ 2,230 $ 1,109 Manufacturing equipment 1,433 945 Computer equipment and software 247 116 Leasehold improvements 123 67 Office furniture 29 19 4,062 2,256 Less: accumulated depreciation and amortization (1,211 ) (999 ) Total $ 2,851 $ 1,257 Accrued Expenses Accrued expenses consist of the following (in thousands): September 30, December 31, 2015 2014 Accrued clinical trial costs $ 1,596 $ 2,397 Accrued other 2,600 649 Total $ 4,196 $ 3,046 |
Commitments and Contingencies
Commitments and Contingencies | 9 Months Ended |
Sep. 30, 2015 | |
Commitments and Contingencies Disclosure [Abstract] | |
Commitments and Contingencies | 5. Commitments and Contingencies License Agreements The following table summarizes costs recognized, in research and development, under the Company’s license agreements and other non-cancellable royalty and milestone obligations (in thousands): Three Months Ended September 30, Nine Months Ended September 30, 2015 2014 2015 2014 License and other fees $ 603 $ 7 $ 614 $ 19 Milestone fees — — 1,000 — Total license and related fees $ 603 $ 7 $ 1,614 $ 19 Intellectual Property Licenses The Company has acquired exclusive rights to develop patented rights, information rights and related know-how for the Company’s OTIPRIO, OTO-104 and OTO-311 product candidates and potential future product candidates under licensing agreements with third parties in the course of its research and development activities. The licensing rights obligate the Company to make payments to the licensors for license fees, milestones, license maintenance fees and royalties. Annual license and maintenance fees related to these agreements is $25,000. The license and maintenance fees will continue until the first commercial sale of a product. The Company is also responsible for patent prosecution costs, in the event such costs are incurred. Under one of these agreements, the Company has achieved five development milestones and one regulatory milestone, totaling $2.2 million, related to its clinical trials for both OTIPRIO and OTO-104, including the $1.0 million regulatory milestone payment made in March 2015 as a result of submitting the OTIPRIO NDA to the FDA. The Company may be obligated to make additional milestone payments under these agreements as follows (in thousands, except share data): Shares of Cash Payments Development 1,066 $ 2,550 Regulatory 1,066 10,150 Commercialization — 1,000 Total 2,132 $ 13,700 In addition, the Company may owe royalties of less than five percent on sales of commercial products, if any, developed using these licensed technologies. The Company may also be obligated to pay to the licensors a percentage of fees received if and when the Company sublicenses the technology. As of September 30, 2015, the Company has not yet developed a commercial product using the licensed technologies and it has not entered into any sublicense agreements for the technologies. Other Royalty Arrangements The Company entered into an agreement related to three provisional patents for OTIPRIO under which the Company may be obligated to pay a one-time milestone payment of $0.5 million upon the first commercial sale of an approved product and to pay royalties of less than one percent on product sales. The royalties are payable until the later of: (i) the expiration of the last to expire patent owned by the Company in such country covering OTIPRIO; or (ii) 10 years after the first commercial sale of OTIPRIO after receipt of regulatory approval for OTIPRIO in such country. During October 2014, the Company entered into an exclusive license agreement with Ipsen that enables the Company to use clinical and non-clinical gacyclidine data generated by Ipsen to support worldwide development and regulatory filings for OTO-311. Under this license agreement, the Company is obligated to pay Ipsen low single-digit royalties on annual net sales of OTO-311 by the Company or its affiliates or sublicensees, up to a maximum cumulative royalty totaling $10.0 million. Leased Facility In May 2015, the Company entered into a lease agreement for a new headquarters location to be constructed in San Diego, California. The lease provides for the landlord to construct the building at its cost and to use reasonable efforts to complete the building by October 2016. The lease term will commence upon the substantial completion and delivery of the building to the Company and has an initial term of 130 months thereafter, with an option by the Company to extend the lease term for an additional five years. The Company has the right to terminate the lease at the end of the 94 th |
Fair Value
Fair Value | 9 Months Ended |
Sep. 30, 2015 | |
Fair Value Disclosures [Abstract] | |
Fair Value | 6. Fair Value The accounting guidance defines fair value, establishes a consistency framework for measuring fair value and expands disclosure for each major asset and liability category measured at fair value on either a recurring basis or nonrecurring basis. Fair value is defined as the price that would be received to sell an asset or paid to transfer a liability in an orderly transaction between market participants on the measurement date. Accounting guidance establishes a three-tier fair value hierarchy that requires an entity to maximize the use of observable inputs and minimize the use of unobservable inputs when measuring fair value. These tiers are based on the source of the inputs and are as follows: Level 1: Level 2: Level 3: The Company held no liabilities measured at fair value on a recurring basis as of September 30, 2015 and December 31, 2014. The following fair value hierarchy table presents the Company’s assets measured at fair value on a recurring basis as of September 30, 2015 and December 31, 2014 (in thousands): Fair Value Measurement at Reporting Date Using Total Level 1 Level 2 Level 3 September 30, 2015: Assets Money market funds $ 11,870 $ 11,870 $ — $ — Certificates of deposit 23,194 — 23,194 — $ 35,064 $ 11,870 $ 23,194 $ — December 31, 2014: Assets Money market funds $ 17,840 $ 17,840 $ — $ — Certificates of deposit 17,160 — 17,160 — $ 35,000 $ 17,840 $ 17,160 $ — |
Stockholders' Equity
Stockholders' Equity | 9 Months Ended |
Sep. 30, 2015 | |
Equity [Abstract] | |
Stockholders' Equity | 7. Stockholders’ Equity Common Stock Subject to Repurchase The Company’s 2010 Equity Incentive Plan allows for early exercise of certain option awards issued under the plan. As of September 30, 2015, options had been exercised for the purchase of 5,629 shares of common stock, which were unvested and subject to repurchase. Under the authoritative guidance, early exercise is not considered an exercise for accounting purposes and, therefore, any payment for unvested shares is recognized as a liability at the original exercise price. As of September 30, 2015, the Company has recorded an early exercise liability of $19,000 and no shares have been repurchased by the Company. Common Stock Reserved for Future Issuance Shares of common stock reserved for future issuance are as follows: September 30, December 31, 2015 2014 Warrants for the purchase of common stock 141,060 142,113 Common stock options issued and outstanding 3,354,274 2,707,477 Common stock options available for future grant 2,261,396 1,953,059 Common stock reserved for issuance under ESPP 672,182 380,000 Total common stock reserved for future issuance 6,428,912 5,182,649 |
Stock-Based Compensation
Stock-Based Compensation | 9 Months Ended |
Sep. 30, 2015 | |
Disclosure of Compensation Related Costs, Share-based Payments [Abstract] | |
Stock-Based Compensation | 8. Stock-Based Compensation The Company’s 2014 Equity Incentive Plan permits the grant of incentive stock options to the Company’s employees and for the grant of nonstatutory stock options, restricted stock, restricted stock units, stock appreciation rights, performance units and performance shares to the Company’s employees, directors and consultants. The Company generally issues time-based stock options which vest over a four-year period commencing with the vesting of 25% on the first anniversary of the date of grant with monthly ratable vesting thereafter. Options grants have a per share exercise price equal to at least 100% of the fair market value of a shares of the common stock as of the date of grant and expire 10 years from the date of grant. The following table summarizes stock option activity for the nine months ended September 30, 2015 (share amounts in thousands): Options Weighted- Outstanding as of December 31, 2014 2,707 $ 10.20 Granted 752 $ 27.75 Exercised (103 ) $ 3.51 Forfeited (2 ) $ 20.61 Outstanding as of September 30, 2015 3,354 $ 14.34 Total non-cash stock-based compensation expense recognized in the accompanying condensed statements of operations is as follows (in thousands): Three Months Ended September 30, Nine Months Ended September 30, 2015 2014 2015 2014 Research and development $ 819 $ 244 $ 2,094 $ 407 General and administrative 1,401 243 3,227 488 Total stock-based compensation $ 2,220 $ 487 $ 5,321 $ 895 |
Description of Business and B14
Description of Business and Basis of Presentation (Policies) | 9 Months Ended |
Sep. 30, 2015 | |
Accounting Policies [Abstract] | |
Basis of Presentation | Basis of Presentation As of September 30, 2015, the Company has devoted substantially all of its efforts to product development, raising capital, and building infrastructure and has not realized revenues from its planned principal operations. The accompanying condensed financial statements have been prepared assuming the Company will continue as a going concern, which contemplates the realization of assets and the satisfaction of liabilities in the normal course of business. The Company has incurred operating losses and negative cash flows from operating activities since inception. As of September 30, 2015, the Company had cash, cash equivalents and short-term investments of $199.2 million and an accumulated deficit of $143.0 million. The Company anticipates that it will continue to incur net losses into the foreseeable future as it: (i) continues the development and begins commercialization of its product candidates OTIPRIO, OTO-104 and OTO-311; (ii) works to develop additional product candidates through research and development programs; and (iii) expands its corporate infrastructure. The Company plans to continue to fund its losses from operations and capital funding needs through future debt and/or equity financings or other sources, such as potential collaboration agreements. If the Company is not able to secure adequate additional funding, the Company may be forced to make reductions in spending, extend payment terms with suppliers, liquidate assets where possible, and/or suspend or curtail planned programs. Any of these actions could materially harm the Company’s business, results of operations, and future prospects. |
Unaudited Interim Financial Information | Unaudited Interim Financial Information The accompanying interim condensed financial statements are unaudited. These unaudited interim condensed financial statements have been prepared in accordance with accounting principles generally accepted in the United States of America (GAAP) and following the requirements of the United States Securities and Exchange Commission (SEC) for interim reporting. As permitted under those rules, certain footnotes or other financial information that are normally required by GAAP can be condensed or omitted. In management’s opinion, the unaudited interim condensed financial statements have been prepared on the same basis as the audited financial statements and include all adjustments, which include only normal recurring adjustments, necessary for the fair presentation of the Company’s financial position, its results of operations and its cash flows for the periods presented. These statements do not include all disclosures required by GAAP and should be read in conjunction with the Company’s audited financial statements and accompanying notes for the year ended December 31, 2014 included in the Company’s Form 10-K. The results presented in these unaudited condensed financial statements are not necessarily indicative of the results expected for the full fiscal year or any other interim period or any future year or period. |
Use of Estimates | Use of Estimates The accompanying condensed financial statements have been prepared in accordance with GAAP. 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 and disclosure of contingent assets and liabilities at the date of the financial statements and the reported amounts of expense during the reporting period. The most significant estimates in the Company’s financial statements relate to clinical trial accruals. Although these estimates are based on the Company’s knowledge of current events and actions it may undertake in the future, actual results may ultimately materially differ from these estimates and assumptions. |
Segment Reporting | Segment Reporting Operating segments are identified as components of an enterprise about which separate discrete financial information is available for evaluation by the chief operating decision-maker in making decisions regarding resource allocation and assessing performance. The Company views its operations and manages its business in one operating segment. |
Concentrations of Credit Risk | Concentrations of Credit Risk Financial instruments that potentially subject the Company to significant concentrations of credit risk consist primarily of cash, cash equivalents and short-term investments. The Company maintains deposits in federally insured financial institutions in excess of federally insured limits. The Company has not experienced any losses in such accounts and believes it is not exposed to significant risk on its cash balances due to the financial position of the depository institutions in which those deposits are held. Additionally, the Company established guidelines regarding approved investments and maturities of investments, which are designed to maintain safety and liquidity. |
Cash and Cash Equivalents | Cash and Cash Equivalents Cash and cash equivalents consist of cash and highly liquid investments with original maturities of three months or less at the date of purchase. The carrying amounts approximate fair value due to the short maturities of these instruments. Cash and cash equivalents include cash in readily available checking, savings and money market accounts, as well as certificates of deposit. |
Short-Term Investments | Short-Term Investments The Company carries short-term investments classified as available-for-sale at fair value as determined by prices for identical or similar securities at the balance sheet date. Short-term investments consist of both Level 1 and Level 2 financial instruments in the fair value hierarchy (see Note 6). Realized gains or losses of available-for-sale securities are determined using the specific identification method and net realized gains and losses are included in interest income. The Company periodically reviews available-for-sale securities for other-than temporary declines in fair value below the cost basis, and whenever events or changes in circumstances indicate that the carrying amount of an asset may not be recoverable. |
Fair Value of Financial Instruments | Fair Value of Financial Instruments The carrying value of the Company’s cash and cash equivalents, short-term investments, prepaid expenses and other current assets, other assets, accounts payable, accrued liabilities, and accrued compensation approximate fair value due to the short-term nature of these items. |
Restricted Cash | Restricted Cash The Company’s restricted cash consists of cash maintained in a separate deposit account to secure a letter of credit issued by a bank to the landlord under a lease agreement for construction of the Company’s new corporate headquarters (see Note 5). The Company has classified the restricted cash as noncurrent on the condensed balance sheet. |
Property and Equipment | Property and Equipment Property and equipment generally consist of manufacturing equipment, furniture and fixtures, computers, and scientific and office equipment and are recorded at cost and depreciated using the straight-line method over the estimated useful lives of the assets (generally three to ten years). Leasehold improvements are stated at cost and are depreciated on a straight-line basis over the lesser of the remaining term of the related lease or the estimated useful lives of the assets. Repairs and maintenance costs are charged to expense as incurred. |
Impairment of Long-Lived Assets | Impairment of Long-Lived Assets The Company assesses the value of its long-lived assets, which consist of property and equipment, for impairment on an annual basis and whenever events or changes in circumstances and the undiscounted cash flows generated by those assets indicate that the carrying amount of such assets may not be recoverable. While the Company’s current and historical operating losses and negative cash flows are indicators of impairment, management believes that future cash flows to be received support the carrying value of its long-lived assets and, accordingly, has not recognized any impairment losses through September 30, 2015. |
Clinical Trial Expense Accruals | Clinical Trial Expense Accruals As part of the process of preparing the Company’s condensed financial statements, the Company is required to estimate expenses resulting from the Company’s obligations under contracts with vendors, clinical research organizations and consultants and under clinical site agreements in connection with conducting clinical trials. The financial terms of these contracts are subject to negotiations, which vary from contract to contract and may result in payment flows that do not match the periods over which materials or services are provided under such contracts. The Company’s objective is to reflect the appropriate clinical trial expenses in its financial statements by recording those expenses in the period in which services are performed and efforts are expended. The Company accounts for these expenses according to the progress of the trial as measured by patient progression and the timing of various aspects of the trial. The Company determines accrual estimates through financial models taking into account discussion with applicable personnel and outside service providers as to the progress or state of its trials. During the course of a clinical trial, the Company adjusts its clinical expense if actual results differ from its estimates. |
Research and Development | Research and Development Research and development expenses include the costs associated with the Company’s research and development activities, including salaries, benefits and occupancy costs. Also included in research and development expenses are third-party costs incurred in conjunction with contract manufacturing for the Company’s research and development programs and clinical trials, including the cost of clinical trial drug supply, costs incurred by contract research organizations and regulatory expenses. Research and development costs are expensed as incurred. |
Patent Expenses | Patent Expenses The Company expenses all costs as incurred in connection with patent applications (including direct application fees, and the legal and consulting expenses related to making such applications) and such costs are included in general and administrative expenses in the accompanying condensed statements of operations. |
Convertible Preferred Stock Warrants | Convertible Preferred Stock Warrants Prior to the Company’s IPO in August 2014, warrants exercisable for shares of the Company’s Series A and Series C convertible preferred stock were classified as liabilities based upon the characteristics and provisions of each instrument. Convertible preferred stock warrants were classified as derivative liabilities and were recorded at their fair value on the date of issuance. At each reporting date the convertible preferred stock warrants were revalued, with fair value changes recognized as increases in or decreases to the change in fair value of convertible preferred stock warrant liability in the statements of operations. In connection with the IPO, all of the Company’s outstanding warrants to purchase convertible preferred stock were either (i) exercised and the underlying shares of preferred stock were automatically converted into shares of common stock or (ii) converted into warrants to purchase common stock. Prior to the exercise and conversion of the warrants to purchase convertible preferred stock, the Company performed the final revaluation of the warrant liability upon the closing of the IPO in August 2014 and recorded the $2.6 million increase in fair value to change in fair value of convertible preferred stock warrant liability in the statements of operations. The warrant liability was then reclassified to additional paid-in capital in the balance sheets. |
Stock-Based Compensation | Stock-Based Compensation The Company accounts for stock-based compensation expense related to stock options and employee stock purchase plan (ESPP) rights by estimating the fair value on the date of grant using the Black-Scholes-Merton option pricing model net of estimated forfeitures. For awards subject to time-based vesting conditions, stock-based compensation expense is recognized using the straight-line method. The Company accounts for stock options granted to non-employees, including members of the scientific advisory board, using the fair value approach. Stock options granted to non-employees may be subject to periodic revaluation over their vesting terms with the related expense being recognized as research and development and/or general and administrative expense in the accompanying condensed statements of operations. |
Income Taxes | Income Taxes The accounting guidance for uncertainty in income taxes prescribes a recognition threshold and measurement attribute criteria for the financial statement recognition and measurement of tax positions taken or expected to be taken in a tax return. For those benefits to be recognized, a tax position must be more likely than not to be sustained upon examination by taxing authorities based on the technical merits of the position. The Company uses the liability method of accounting for income taxes. Under this method, deferred tax assets and liabilities are determined based on the difference between the financial reporting and the tax reporting basis of assets and liabilities and are measured using the enacted tax rates and laws that are expected to be in effect when the differences are expected to reverse. The Company provides a valuation allowance against net deferred tax assets unless, based upon the available evidence, it is more likely than not that the deferred tax assets will be realized. When the Company establishes or reduces the valuation allowance against its deferred tax assets, its provision for income taxes will increase or decrease, respectively, in the period such determination is made. |
Comprehensive Loss | Comprehensive Loss Comprehensive loss is defined as the change in equity during a period from transactions and other events and/or circumstances from non-owner sources. For all periods presented, comprehensive loss is equal to net loss. |
Net Loss Per Share | Net Loss Per Share Basic net loss per common share is calculated by dividing the net loss attributable to common stockholders by the weighted-average number of common shares outstanding during the period, without consideration for potentially dilutive securities. Diluted net loss per share is computed by dividing the net loss attributable to common stockholders by the weighted-average number of common shares and potentially dilutive securities outstanding for the period determined using the treasury-stock and if-converted methods. For purposes of the diluted net loss per share calculation, potentially dilutive securities are excluded from the calculation of diluted net loss per share because their effect would be anti-dilutive and therefore, basic and diluted net loss per share were the same for all periods presented. |
Summary of Significant Accoun15
Summary of Significant Accounting Policies (Tables) | 9 Months Ended |
Sep. 30, 2015 | |
Accounting Policies [Abstract] | |
Potentially Dilutive Securities Excluded from Calculation of Diluted Net Loss Per Share Attributable to Common Stockholders | Potentially dilutive securities excluded from the calculation of diluted net loss per share attributable to common stockholders are as follows (in common stock equivalent shares): Three and Nine Months Ended September 30, 2015 2014 Warrants to purchase common stock 141,060 142,113 Unvested restricted common stock subject to repurchase 5,629 16,294 Options to purchase common stock 3,354,274 2,058,910 3,500,963 2,217,317 |
Balance Sheet Details (Tables)
Balance Sheet Details (Tables) | 9 Months Ended |
Sep. 30, 2015 | |
Organization, Consolidation and Presentation of Financial Statements [Abstract] | |
Prepaid and Other Current Assets | Prepaid and other current assets are comprised of the following (in thousands): September 30, December 31, 2015 2014 Prepaid clinical trial costs $ 1,485 $ 843 FDA deposit (1) 2,335 — Other 1,440 826 Total $ 5,260 $ 1,669 (1) In February 2015, in accordance with the Federal Food, Drug, and Cosmetic Act (the “Act”), the Company paid an application fee of $2.3 million to the FDA for its OTIPRIO NDA submission. Prior to the submission of the OTIPRIO NDA, the Company filed a request with the FDA to grant a waiver and refund of the application fee under the small business waiver provision of the Act. During October 2015, the FDA granted the Company’s request for a waiver and refunded the application fee in full. |
Property and Equipment, Net | Property and equipment, net consists of the following (in thousands): September 30, December 31, 2015 2014 Laboratory equipment $ 2,230 $ 1,109 Manufacturing equipment 1,433 945 Computer equipment and software 247 116 Leasehold improvements 123 67 Office furniture 29 19 4,062 2,256 Less: accumulated depreciation and amortization (1,211 ) (999 ) Total $ 2,851 $ 1,257 |
Accrued Expenses | Accrued expenses consist of the following (in thousands): September 30, December 31, 2015 2014 Accrued clinical trial costs $ 1,596 $ 2,397 Accrued other 2,600 649 Total $ 4,196 $ 3,046 |
Commitments and Contingencies (
Commitments and Contingencies (Tables) | 9 Months Ended |
Sep. 30, 2015 | |
Commitments and Contingencies Disclosure [Abstract] | |
Summary of Costs Recognized Under License Agreements and Other Non-Cancellable Royalty and Milestone Obligations | The following table summarizes costs recognized, in research and development, under the Company’s license agreements and other non-cancellable royalty and milestone obligations (in thousands): Three Months Ended September 30, Nine Months Ended September 30, 2015 2014 2015 2014 License and other fees $ 603 $ 7 $ 614 $ 19 Milestone fees — — 1,000 — Total license and related fees $ 603 $ 7 $ 1,614 $ 19 |
Schedule of Additional Milestone Payments | The Company may be obligated to make additional milestone payments under these agreements as follows (in thousands, except share data): Shares of Cash Payments Development 1,066 $ 2,550 Regulatory 1,066 10,150 Commercialization — 1,000 Total 2,132 $ 13,700 |
Fair Value (Tables)
Fair Value (Tables) | 9 Months Ended |
Sep. 30, 2015 | |
Fair Value Disclosures [Abstract] | |
Fair Value Assets Measured on a Recurring Basis | The following fair value hierarchy table presents the Company’s assets measured at fair value on a recurring basis as of September 30, 2015 and December 31, 2014 (in thousands): Fair Value Measurement at Reporting Date Using Total Level 1 Level 2 Level 3 September 30, 2015: Assets Money market funds $ 11,870 $ 11,870 $ — $ — Certificates of deposit 23,194 — 23,194 — $ 35,064 $ 11,870 $ 23,194 $ — December 31, 2014: Assets Money market funds $ 17,840 $ 17,840 $ — $ — Certificates of deposit 17,160 — 17,160 — $ 35,000 $ 17,840 $ 17,160 $ — |
Stockholders' Equity (Tables)
Stockholders' Equity (Tables) | 9 Months Ended |
Sep. 30, 2015 | |
Equity [Abstract] | |
Schedule of Shares of Common Stock Reserved for Future Issuance | Shares of common stock reserved for future issuance are as follows: September 30, December 31, 2015 2014 Warrants for the purchase of common stock 141,060 142,113 Common stock options issued and outstanding 3,354,274 2,707,477 Common stock options available for future grant 2,261,396 1,953,059 Common stock reserved for issuance under ESPP 672,182 380,000 Total common stock reserved for future issuance 6,428,912 5,182,649 |
Stock-Based Compensation (Table
Stock-Based Compensation (Tables) | 9 Months Ended |
Sep. 30, 2015 | |
Disclosure of Compensation Related Costs, Share-based Payments [Abstract] | |
Summary of Stock Option Activity | The following table summarizes stock option activity for the nine months ended September 30, 2015 (share amounts in thousands): Options Weighted- Outstanding as of December 31, 2014 2,707 $ 10.20 Granted 752 $ 27.75 Exercised (103 ) $ 3.51 Forfeited (2 ) $ 20.61 Outstanding as of September 30, 2015 3,354 $ 14.34 |
Summary of Non-cash Stock Based Compensation Expense | Total non-cash stock-based compensation expense recognized in the accompanying condensed statements of operations is as follows (in thousands): Three Months Ended September 30, Nine Months Ended September 30, 2015 2014 2015 2014 Research and development $ 819 $ 244 $ 2,094 $ 407 General and administrative 1,401 243 3,227 488 Total stock-based compensation $ 2,220 $ 487 $ 5,321 $ 895 |
Description of Business and B21
Description of Business and Basis of Presentation - Additional Information (Detail) $ / shares in Units, $ in Thousands | 1 Months Ended | 9 Months Ended | ||
Jan. 31, 2015USD ($)$ / sharesshares | Aug. 31, 2014USD ($)$ / sharesshares | Sep. 30, 2015USD ($) | Dec. 31, 2014USD ($) | |
Description Of Business And Basis Of Presentation [Line Items] | ||||
Reverse stock split description | On July 31, 2014, the Company filed an amendment to its amended and restated certificate of incorporation, affecting a one-for-35.16 reverse stock split of its outstanding common and convertible preferred stock, which was approved by the Company's board of directors on July 29, 2014. | |||
Reverse stock split conversion ratio | 0.0284414107 | |||
Cash, cash equivalents and short-term investments | $ 199,200 | |||
Accumulated deficit | $ (142,995) | $ (102,469) | ||
Common stock [Member] | Follow On Public Offering [Member] | ||||
Description Of Business And Basis Of Presentation [Line Items] | ||||
Number of shares issued | shares | 2,932,500 | |||
Price per share | $ / shares | $ 29.25 | |||
Proceeds from public offering | $ 80,000 | |||
Common stock [Member] | Over-Allotment Option [Member] | ||||
Description Of Business And Basis Of Presentation [Line Items] | ||||
Number of shares issued | shares | 382,500 | 937,500 | ||
Common stock [Member] | IPO [Member] | ||||
Description Of Business And Basis Of Presentation [Line Items] | ||||
Number of shares issued | shares | 7,187,500 | |||
Price per share | $ / shares | $ 16 | |||
Proceeds from public offering | $ 104,100 |
Summary of Significant Accoun22
Summary of Significant Accounting Policies - Additional Information (Detail) | 1 Months Ended | 3 Months Ended | 9 Months Ended | ||
Aug. 31, 2014USD ($) | Sep. 30, 2015USD ($) | Sep. 30, 2014USD ($) | Sep. 30, 2015USD ($)Segment | Sep. 30, 2014USD ($) | |
Summary Of Significant Accounting Policies [Line Items] | |||||
Number of operating segments | Segment | 1 | ||||
Impairment loss | $ 0 | ||||
Change in fair value of convertible preferred stock warrant liability | $ 2,600,000 | $ 0 | $ 2,632,000 | $ 0 | $ 3,300,000 |
Minimum [Member] | |||||
Summary Of Significant Accounting Policies [Line Items] | |||||
Property and equipment useful lives | 3 years | ||||
Maximum [Member] | |||||
Summary Of Significant Accounting Policies [Line Items] | |||||
Property and equipment useful lives | 10 years |
Summary of Significant Accoun23
Summary of Significant Accounting Policies - Potentially Dilutive Securities Excluded from Calculation of Diluted Net Loss Per Share Attributable to Common Stockholders (Detail) - shares | 3 Months Ended | 9 Months Ended | ||
Sep. 30, 2015 | Sep. 30, 2014 | Sep. 30, 2015 | Sep. 30, 2014 | |
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] | ||||
Potentially dilutive securities excluded from the calculation of diluted net loss per share | 3,500,963 | 2,217,317 | 3,500,963 | 2,217,317 |
Warrants to purchase common stock [Member] | ||||
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] | ||||
Potentially dilutive securities excluded from the calculation of diluted net loss per share | 141,060 | 142,113 | 141,060 | 142,113 |
Unvested restricted common stock subject to repurchase [Member] | ||||
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] | ||||
Potentially dilutive securities excluded from the calculation of diluted net loss per share | 5,629 | 16,294 | 5,629 | 16,294 |
Options to purchase common stock [Member] | ||||
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] | ||||
Potentially dilutive securities excluded from the calculation of diluted net loss per share | 3,354,274 | 2,058,910 | 3,354,274 | 2,058,910 |
Available-for-Sale Securities -
Available-for-Sale Securities - Additional Information (Detail) - USD ($) | 9 Months Ended | |||
Sep. 30, 2015 | Dec. 31, 2014 | Sep. 30, 2014 | Dec. 31, 2013 | |
Schedule of Available-for-sale Securities [Line Items] | ||||
Cash and cash equivalents | $ 176,602,000 | $ 139,810,000 | $ 165,155,000 | $ 37,284,000 |
Short-term investments | 22,587,000 | 16,223,000 | ||
Unrealized gains or losses | 0 | |||
Other-than-temporary declines in the value of any available-for-sale securities | $ 0 | |||
Maximum maturity of available-for-sale investment securities | One year | |||
Certificates of deposit [Member] | ||||
Schedule of Available-for-sale Securities [Line Items] | ||||
Short-term investments | $ 22,600,000 | 16,200,000 | ||
Available-for-sale Securities [Member] | Money market funds and certificates of deposit [Member] | ||||
Schedule of Available-for-sale Securities [Line Items] | ||||
Cash and cash equivalents | $ 12,500,000 | $ 18,800,000 |
Balance Sheet Details - Prepaid
Balance Sheet Details - Prepaid and Other Current Assets (Detail) - USD ($) $ in Thousands | Sep. 30, 2015 | Dec. 31, 2014 |
Deferred Costs, Capitalized, Prepaid, and Other Assets Disclosure [Abstract] | ||
Prepaid clinical trial costs | $ 1,485 | $ 843 |
FDA deposit | 2,335 | 0 |
Other | 1,440 | 826 |
Total | $ 5,260 | $ 1,669 |
Balance Sheet Details - Prepa26
Balance Sheet Details - Prepaid and Other Current Assets (Parenthetical) (Detail) $ in Millions | 1 Months Ended |
Feb. 28, 2015USD ($) | |
Deferred Costs, Capitalized, Prepaid, and Other Assets Disclosure [Abstract] | |
FDA application fee | $ 2.3 |
Balance Sheet Details - Propert
Balance Sheet Details - Property and Equipment, Net (Detail) - USD ($) $ in Thousands | Sep. 30, 2015 | Dec. 31, 2014 |
Property, Plant and Equipment [Line Items] | ||
Property and equipment, gross | $ 4,062 | $ 2,256 |
Less: accumulated depreciation and amortization | (1,211) | (999) |
Total | 2,851 | 1,257 |
Laboratory Equipment [Member] | ||
Property, Plant and Equipment [Line Items] | ||
Property and equipment, gross | 2,230 | 1,109 |
Manufacturing Equipment [Member] | ||
Property, Plant and Equipment [Line Items] | ||
Property and equipment, gross | 1,433 | 945 |
Computer Equipment and Software [Member] | ||
Property, Plant and Equipment [Line Items] | ||
Property and equipment, gross | 247 | 116 |
Leasehold Improvements [Member] | ||
Property, Plant and Equipment [Line Items] | ||
Property and equipment, gross | 123 | 67 |
Office Furniture [Member] | ||
Property, Plant and Equipment [Line Items] | ||
Property and equipment, gross | $ 29 | $ 19 |
Balance Sheet Details - Accrued
Balance Sheet Details - Accrued Expenses (Detail) - USD ($) $ in Thousands | Sep. 30, 2015 | Dec. 31, 2014 |
Payables and Accruals [Abstract] | ||
Accrued clinical trial costs | $ 1,596 | $ 2,397 |
Accrued other | 2,600 | 649 |
Total | $ 4,196 | $ 3,046 |
Commitments and Contingencies -
Commitments and Contingencies - Summary of Costs Recognized Under License Agreements and Other Non-Cancellable Royalty and Milestone Obligations (Detail) - USD ($) $ in Thousands | 3 Months Ended | 9 Months Ended | ||
Sep. 30, 2015 | Sep. 30, 2014 | Sep. 30, 2015 | Sep. 30, 2014 | |
Commitments and Contingencies Disclosure [Abstract] | ||||
License and other fees | $ 603 | $ 7 | $ 614 | $ 19 |
Milestone fees | 0 | 0 | 1,000 | 0 |
Total license and related fees | $ 603 | $ 7 | $ 1,614 | $ 19 |
Commitments and Contingencies30
Commitments and Contingencies - Additional Information (Detail) | May. 31, 2015USD ($) | Mar. 31, 2015USD ($) | Sep. 30, 2015USD ($) | Sep. 30, 2014USD ($) | Sep. 30, 2015USD ($)MilestonePatents | Sep. 30, 2014USD ($) | Oct. 31, 2014USD ($) |
Other Commitments [Line Items] | |||||||
Milestone fees | $ 0 | $ 0 | $ 1,000,000 | $ 0 | |||
Operating lease term | 130 months | ||||||
Additional operating lease term | 5 years | ||||||
Period after which company has the right to terminate lease if it is acquired by a third party and pays early termination fee | 94 months | ||||||
Base rent for first year | $ 232,000 | ||||||
Lease rate increase, percentage | 3.00% | ||||||
Abatement period of monthly base rent | 10 months | ||||||
Estimated base rent payments over the life of lease | $ 32,700,000 | ||||||
Noncurrent restricted cash [Member] | |||||||
Other Commitments [Line Items] | |||||||
Security deposit in the form of letter of credit | $ 695,000 | ||||||
Building [Member] | |||||||
Other Commitments [Line Items] | |||||||
Construction completion period | 2016-10 | ||||||
Intellectual Property [Member] | |||||||
Other Commitments [Line Items] | |||||||
Annual license and maintenance fees | 25,000 | ||||||
Milestone fees | $ 2,200,000 | ||||||
Maximum percentage of royalties on sales | 5.00% | ||||||
Intellectual Property [Member] | Regulatory [Member] | |||||||
Other Commitments [Line Items] | |||||||
Number of milestones achieved | Milestone | 1 | ||||||
Milestone payment | $ 1,000,000 | ||||||
Intellectual Property [Member] | Development [Member] | |||||||
Other Commitments [Line Items] | |||||||
Number of milestones achieved | Milestone | 5 | ||||||
Royalty Agreements [Member] | |||||||
Other Commitments [Line Items] | |||||||
Milestone fees | $ 500,000 | ||||||
Maximum percentage of royalties on sales | 1.00% | ||||||
Number of provisional patents | Patents | 3 | ||||||
Royalty period | 10 years | ||||||
Data License Agreement [Member] | |||||||
Other Commitments [Line Items] | |||||||
Description of royalties payable | The Company is obligated to pay Ipsen low single-digit royalties on annual net sales of OTO-311 by the Company or its affiliates or sublicensees | ||||||
Maximum cumulative royalties paid under license agreement | $ 10,000,000 |
Commitments and Contingencies31
Commitments and Contingencies - Schedule of Additional Milestone Payments (Detail) $ in Thousands | 9 Months Ended |
Sep. 30, 2015USD ($)shares | |
Other Commitments [Line Items] | |
Shares of Common Stock | 2,132 |
Cash Payments | $ | $ 13,700 |
Development [Member] | |
Other Commitments [Line Items] | |
Shares of Common Stock | 1,066 |
Cash Payments | $ | $ 2,550 |
Regulatory [Member] | |
Other Commitments [Line Items] | |
Shares of Common Stock | 1,066 |
Cash Payments | $ | $ 10,150 |
Commercialization [Member] | |
Other Commitments [Line Items] | |
Shares of Common Stock | 0 |
Cash Payments | $ | $ 1,000 |
Fair Value - Additional informa
Fair Value - Additional information (Detail) - USD ($) | Sep. 30, 2015 | Dec. 31, 2014 |
Fair Value Disclosures [Abstract] | ||
Liabilities measured at fair value on recurring basis | $ 0 | $ 0 |
Fair Value - Fair Value Assets
Fair Value - Fair Value Assets Measured on a Recurring Basis (Detail) - Fair Value Measurements, Recurring [Member] - USD ($) $ in Thousands | Sep. 30, 2015 | Dec. 31, 2014 |
Assets | ||
Total assets | $ 35,064 | $ 35,000 |
Money market funds [Member] | ||
Assets | ||
Money market funds | 11,870 | 17,840 |
Certificates of deposit [Member] | ||
Assets | ||
Short-term investments | 23,194 | 17,160 |
Level 1 [Member] | ||
Assets | ||
Total assets | 11,870 | 17,840 |
Level 1 [Member] | Money market funds [Member] | ||
Assets | ||
Money market funds | 11,870 | 17,840 |
Level 1 [Member] | Certificates of deposit [Member] | ||
Assets | ||
Short-term investments | 0 | 0 |
Level 2 [Member] | ||
Assets | ||
Total assets | 23,194 | 17,160 |
Level 2 [Member] | Money market funds [Member] | ||
Assets | ||
Money market funds | 0 | 0 |
Level 2 [Member] | Certificates of deposit [Member] | ||
Assets | ||
Short-term investments | 23,194 | 17,160 |
Level 3 [Member] | ||
Assets | ||
Total assets | 0 | 0 |
Level 3 [Member] | Money market funds [Member] | ||
Assets | ||
Money market funds | 0 | 0 |
Level 3 [Member] | Certificates of deposit [Member] | ||
Assets | ||
Short-term investments | $ 0 | $ 0 |
Stockholders' Equity - Addition
Stockholders' Equity - Additional Information (Detail) - Equity Incentive Plan 2010 [Member] | 9 Months Ended |
Sep. 30, 2015USD ($)shares | |
Class of Stock [Line Items] | |
Early exercised option awards | 5,629 |
Early exercised option awards liability | $ | $ 19,000 |
Shares repurchased | 0 |
Stockholders' Equity - Schedule
Stockholders' Equity - Schedule of Shares of Common Stock Reserved for Future Issuance (Detail) - shares | Sep. 30, 2015 | Dec. 31, 2014 |
Class of Stock [Line Items] | ||
Total common stock reserved for future issuance | 6,428,912 | 5,182,649 |
Warrants to purchase common stock [Member] | ||
Class of Stock [Line Items] | ||
Total common stock reserved for future issuance | 141,060 | 142,113 |
Options to purchase common stock [Member] | ||
Class of Stock [Line Items] | ||
Total common stock reserved for future issuance | 3,354,274 | 2,707,477 |
Available Future Grant Year [Member] | Options to purchase common stock [Member] | ||
Class of Stock [Line Items] | ||
Total common stock reserved for future issuance | 2,261,396 | 1,953,059 |
2014 Employee Stock Purchase Plan [Member] | ||
Class of Stock [Line Items] | ||
Total common stock reserved for future issuance | 672,182 | 380,000 |
Stock-Based Compensation - Addi
Stock-Based Compensation - Additional Information (Detail) - Equity Incentive Plan 2014 [Member] | 9 Months Ended |
Sep. 30, 2015 | |
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |
Contractual term of options | 10 years |
Share based compensation vesting period | 4 years |
First Anniversary of Grant Date [Member] | |
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |
Share based compensation vesting percentage | 25.00% |
Minimum [Member] | |
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |
Exercise price, percentage of fair market value | 100.00% |
Stock-Based Compensation - Summ
Stock-Based Compensation - Summary of Stock Option Activity (Detail) shares in Thousands | 9 Months Ended |
Sep. 30, 2015$ / sharesshares | |
Options | |
Options Outstanding, beginning of period | 2,707 |
Options, Granted | 752 |
Options, Exercised | (103) |
Options, Forfeited | (2) |
Options Outstanding, end of period | 3,354 |
Weighted-Average Exercise Price | |
Weighted-Average Exercise Price, beginning of period | $ / shares | $ 10.20 |
Weighted-Average Exercise Price, Granted | $ / shares | 27.75 |
Weighted-Average Exercise Price, Exercised | $ / shares | 3.51 |
Weighted-Average Exercise Price, Forfeited | $ / shares | 20.61 |
Weighted-Average Exercise Price, end of period | $ / shares | $ 14.34 |
Stock-Based Compensation - Su38
Stock-Based Compensation - Summary of Non-cash Stock Based Compensation Expense (Detail) - USD ($) $ in Thousands | 3 Months Ended | 9 Months Ended | ||
Sep. 30, 2015 | Sep. 30, 2014 | Sep. 30, 2015 | Sep. 30, 2014 | |
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||
Total stock-based compensation | $ 2,220 | $ 487 | $ 5,321 | $ 895 |
Research and development [Member] | ||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||
Total stock-based compensation | 819 | 244 | 2,094 | 407 |
General and administrative [Member] | ||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||
Total stock-based compensation | $ 1,401 | $ 243 | $ 3,227 | $ 488 |