Document and Entity Information
Document and Entity Information - shares | 3 Months Ended | |
Mar. 31, 2020 | May 04, 2020 | |
Cover [Abstract] | ||
Document Type | 10-Q | |
Amendment Flag | false | |
Document Period End Date | Mar. 31, 2020 | |
Document Fiscal Year Focus | 2020 | |
Document Fiscal Period Focus | Q1 | |
Trading Symbol | OTIC | |
Security Exchange Name | NASDAQ | |
Title of 12(b) Security | Common stock, par value $0.001 per share | |
Entity Registrant Name | Otonomy, Inc. | |
Entity Central Index Key | 0001493566 | |
Current Fiscal Year End Date | --12-31 | |
Entity Filer Category | Accelerated Filer | |
Entity Small Business | true | |
Entity Emerging Growth Company | false | |
Entity Common Stock, Shares Outstanding | 30,867,961 | |
Entity Current Reporting Status | Yes | |
Entity Shell Company | false | |
Entity File Number | 001-36591 | |
Entity Incorporation, State or Country Code | DE | |
Entity Tax Identification Number | 26-2590070 | |
Entity Address, Address Line One | 4796 Executive Drive | |
Entity Address, City or Town | San Diego | |
Entity Address, State or Province | CA | |
Entity Address, Postal Zip Code | 92121 | |
City Area Code | 619 | |
Local Phone Number | 323-2200 | |
Document Quarterly Report | true | |
Document Transition Report | false | |
Entity Interactive Data Current | Yes |
Condensed Balance Sheets
Condensed Balance Sheets - USD ($) $ in Thousands | Mar. 31, 2020 | Dec. 31, 2019 |
Current assets: | ||
Cash and cash equivalents | $ 31,038 | $ 25,194 |
Short-term investments | 17,568 | 35,476 |
Prepaid and other current assets | 2,199 | 2,480 |
Total current assets | 50,805 | 63,150 |
Restricted cash | 702 | 701 |
Property and equipment, net | 3,413 | 3,702 |
Right-of-use assets | 15,131 | 15,465 |
Total assets | 70,051 | 83,018 |
Current liabilities: | ||
Accounts payable | 897 | 1,161 |
Accrued expenses | 4,512 | 5,442 |
Accrued compensation | 1,429 | 2,593 |
Long-term debt, current | 1,286 | 0 |
Leases, current | 3,308 | 3,302 |
Total current liabilities | 11,432 | 12,498 |
Long-term debt, net of current | 13,731 | 14,967 |
Leases, net of current | 14,951 | 15,320 |
Total liabilities | 40,114 | 42,785 |
Commitments and Contingencies | 0 | 0 |
Stockholders’ equity: | ||
Preferred stock, $0.001 par value; 10,000,000 shares authorized at March 31, 2020 and December 31, 2019; no shares issued or outstanding at March 31, 2020 and December 31, 2019 | 0 | 0 |
Common stock, $0.001 par value; 200,000,000 shares authorized at March 31, 2020 and December 31, 2019; 30,814,211 shares issued and outstanding at March 31, 2020 and December 31, 2019 | 31 | 31 |
Additional paid-in capital | 501,498 | 500,084 |
Accumulated other comprehensive income | 64 | 11 |
Accumulated deficit | (471,656) | (459,893) |
Total stockholders’ equity | 29,937 | 40,233 |
Total liabilities and stockholders’ equity | $ 70,051 | $ 83,018 |
Condensed Balance Sheets (Paren
Condensed Balance Sheets (Parenthetical) - $ / shares | Mar. 31, 2020 | Dec. 31, 2019 |
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 | 30,814,211 | 30,814,211 |
Common stock, Shares outstanding | 30,814,211 | 30,814,211 |
Condensed Statements of Operati
Condensed Statements of Operations - USD ($) $ in Thousands | 3 Months Ended | |
Mar. 31, 2020 | Mar. 31, 2019 | |
Income Statement [Abstract] | ||
Product sales, net | $ 160 | $ 192 |
Type of Revenue [Extensible List] | us-gaap:ProductMember | us-gaap:ProductMember |
Costs and operating expenses: | ||
Cost of product sales | $ 214 | $ 213 |
Type of Cost, Good or Service [Extensible List] | us-gaap:ProductMember | us-gaap:ProductMember |
Research and development | $ 7,672 | $ 8,795 |
Selling, general and administrative | 3,836 | 3,278 |
Total costs and operating expenses | 11,722 | 12,286 |
Loss from operations | (11,562) | (12,094) |
Other income (expense) | ||
Interest income | 193 | 501 |
Interest expense | (394) | (391) |
Net loss | $ (11,763) | $ (11,984) |
Net loss per share, basic and diluted | $ (0.38) | $ (0.39) |
Weighted-average shares used to compute net loss per share, basic and diluted | 30,814,211 | 30,658,412 |
Condensed Statements of Compreh
Condensed Statements of Comprehensive Loss - USD ($) $ in Thousands | 3 Months Ended | |
Mar. 31, 2020 | Mar. 31, 2019 | |
Statement Of Income And Comprehensive Income [Abstract] | ||
Net loss | $ (11,763) | $ (11,984) |
Other comprehensive income: | ||
Unrealized gain on available for sale securities | 53 | 40 |
Comprehensive loss | $ (11,710) | $ (11,944) |
Condensed Statements of Stockho
Condensed Statements of Stockholders' Equity - USD ($) $ in Thousands | Total | Common Stock [Member] | Additional Paid-in Capital [Member] | Accumulated Other Comprehensive (Loss) Income [Member] | Accumulated Deficit [Member] |
Beginning balance at Dec. 31, 2018 | $ 79,737 | $ 31 | $ 494,947 | $ (23) | $ (415,218) |
Beginning balance, shares at Dec. 31, 2018 | 30,685,412 | ||||
Stock-based compensation expense (unaudited) | 1,496 | 1,496 | |||
Net loss (unaudited) | (11,984) | (11,984) | |||
Unrealized gain on available- for-sale securities (unaudited) | 40 | 40 | |||
Ending balance (unaudited) at Mar. 31, 2019 | 69,289 | $ 31 | 496,443 | 17 | (427,202) |
Ending balance (unaudited), shares at Mar. 31, 2019 | 30,685,412 | ||||
Beginning balance at Dec. 31, 2019 | 40,233 | $ 31 | 500,084 | 11 | (459,893) |
Beginning balance, shares at Dec. 31, 2019 | 30,814,211 | ||||
Stock-based compensation expense (unaudited) | 1,414 | 1,414 | |||
Net loss (unaudited) | (11,763) | (11,763) | |||
Unrealized gain on available- for-sale securities (unaudited) | 53 | 53 | |||
Ending balance (unaudited) at Mar. 31, 2020 | $ 29,937 | $ 31 | $ 501,498 | $ 64 | $ (471,656) |
Ending balance (unaudited), shares at Mar. 31, 2020 | 30,814,211 |
Condensed Statements of Cash Fl
Condensed Statements of Cash Flows - USD ($) $ in Thousands | 3 Months Ended | |
Mar. 31, 2020 | Mar. 31, 2019 | |
Cash flows from operating activities: | ||
Net loss | $ (11,763) | $ (11,984) |
Adjustments to reconcile net loss to net cash used in operating activities: | ||
Depreciation | 286 | 276 |
Stock-based compensation | 1,414 | 1,496 |
Accretion of discounts on short-term investments | (35) | (217) |
Amortization of debt discount | 50 | 44 |
Changes in operating assets and liabilities: | ||
Prepaid and other assets | 281 | 678 |
Accounts payable | (264) | 123 |
Accrued expenses | (917) | 462 |
Accrued compensation | (1,164) | (1,392) |
Right-of-use assets and lease liabilities, net | (29) | 10 |
Net cash used in operating activities | (12,141) | (10,504) |
Cash flows from investing activities: | ||
Purchases of short-term investments | (3,004) | (32,763) |
Maturities of short-term investments | 21,000 | 26,000 |
Purchases of property and equipment | (10) | (36) |
Net cash provided by (used in) investing activities | 17,986 | (6,799) |
Cash flows from financing activities: | ||
Payments of debt issuance costs | 0 | (52) |
Net cash used in financing activities | 0 | (52) |
Net change in cash, cash equivalents and restricted cash | 5,845 | (17,355) |
Cash, cash equivalents and restricted cash at beginning of period | 25,895 | 34,329 |
Cash, cash equivalents and restricted cash at end of period | 31,740 | 16,974 |
Cash and cash equivalents at end of period | 31,038 | 16,276 |
Restricted cash at end of period | 702 | 698 |
Supplemental cash flow disclosures | ||
Cash paid for interest | 341 | 347 |
Supplemental disclosure of non-cash investing activities: | ||
Purchase of property and equipment in accounts payable and accrued expenses | $ 63 | $ 0 |
Description of Business and Bas
Description of Business and Basis of Presentation | 3 Months Ended |
Mar. 31, 2020 | |
Accounting Policies [Abstract] | |
Description of Business and Basis of Presentation | 1. Description of Business and Basis of Presentation Description of Business Otonomy, Inc. (Otonomy or the Company) was incorporated in the state of Delaware on May 6, 2008. Otonomy is a biopharmaceutical company dedicated to the development of innovative therapeutics for neurotology. The Company pioneered the application of drug delivery technology to the ear in order to develop products that achieve sustained drug exposure from a single local administration. This approach is covered by a broad patent estate and is being utilized to develop a pipeline of products addressing important unmet medical needs including Ménière’s disease, hearing loss and tinnitus. OTIVIDEX is a sustained-exposure formulation of the steroid dexamethasone that has completed two Phase 3 trials for the treatment of Ménière’s disease, with a third Phase 3 trial currently enrolling patients. OTO-313 is a sustained-exposure formulation of the potent and selective N-Methyl-D-Aspartate (NMDA) receptor antagonist gacyclidine that has recently completed enrollment of tinnitus patients in a Phase 1/2 clinical trial. OTO-413 is a sustained-exposure formulation of brain-derived neurotrophic factor (BDNF) for the repair of cochlear synaptopathy, an underlying cause of hearing loss, that is enrolling hearing loss patients in a Phase 1/2 clinical trial. Otonomy also has preclinical stage programs addressing prevention of cisplatin-induced hearing loss (OTO-510) and hair cell regeneration for severe hearing loss (OTO-6XX). In October 2019, the Company entered into a collaboration with Applied Genetic Technologies Corporation (AGTC), to co-develop and co-commercialize a gene therapy to restore hearing in patients with congenital hearing loss. In addition, the Company developed, received United States Food and Drug Administration (FDA) approval and commercially launched OTIPRIO for use during tympanostomy tube placement (TTP) surgery in pediatric patients. OTIPRIO was also approved by the FDA for the treatment of acute otitis externa (AOE). Liquidity and Financial Condition The Company follows Accounting Standards Codification (ASC) Topic 205-40, Presentation of Financial Statements—Going Concern The 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 March 31, 2020, the Company had cash, cash equivalents and short-term investments of $48.6 million and an accumulated deficit of $471.7 million. The Company anticipates that it will continue to incur net losses into the foreseeable future as it: (i) develops and seeks regulatory approvals for OTIVIDEX and its other product candidates; and (ii) works to develop additional product candidates through research and development programs. The Company intends to seek additional funding through future debt and/or equity financings or other sources, such as potential collaboration agreements. Additional capital may not be available in sufficient amounts or on reasonable terms, if at all. If the Company is not able to secure adequate additional funding, if or when necessary, 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. The Company believes that its existing cash, cash equivalents and short-term investments that include proceeds from its long-term debt will be sufficient to fund its operations for a period of at least twelve months from the date of this report. Basis of Presentation 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 the Company’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, results of operations and cash flows for the periods presented. These condensed financial 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, 2019 included in the Company’s Annual Report on Form 10-K, as filed with the SEC on February 27, 2020. 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 | 3 Months Ended |
Mar. 31, 2020 | |
Accounting Policies [Abstract] | |
Summary of Significant Accounting Policies | 2. Summary of Significant Accounting Policies Use of Estimates The condensed financial statements have been prepared in accordance with GAAP. The preparation of financial statements in conformity with GAAP requires the Company 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 product sales and expense during the reporting period. Although these estimates are based on the Company’s knowledge of current events and anticipated actions it may undertake in the future, actual results may ultimately materially differ from these estimates and assumptions. Short-term Investments The Company carries short-term investments classified as available-for-sale debt securities 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 – Fair Value 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. The Company records unrealized gains and losses on available-for-sale debt securities as a component of other comprehensive loss within the condensed statements of comprehensive loss and as a separate component of stockholders’ equity on the condensed balance sheets. The Company does not hold equity securities in its investment portfolio. Fair Value of Financial Instruments The Company’s financial instruments include cash, cash equivalents, short-term investments, prepaid expenses and other assets, accounts payable, accrued expenses, accrued compensation and long-term debt. The carrying value of the Company’s cash and cash equivalents, short-term investments, prepaid expenses and other current assets, other long-term assets, accounts payable, accrued expenses, and accrued compensation approximate fair value due to the short-term nature of these items. Based on Level 3 inputs and the borrowing rates currently available for loans with similar terms, the Company believes the fair value of long-term debt approximates its carrying value. Risks and Uncertainties Related to COVID-19 In March 2020, the World Health Organization declared coronavirus COVID-19 a global pandemic. The COVID-19 pandemic could pose significant risks to the Company’s business; however, the ultimate impact of the pandemic is highly uncertain. The Company does not yet know the full extent of potential delays or impacts on its business, its preclinical programs and clinical trials, healthcare systems or the global economy as a whole. As such, it is uncertain as to the full magnitude that the COVID-19 pandemic will have on the Company’s financial condition, liquidity and future results of operations. Recent Accounting Pronouncements Not Yet Adopted In June 2016, Accounting Standards Update (ASU) No. 2016-13, Financial Instruments—Credit Losses (Topic 326): Measurement of Credit Losses on Financial Instruments . Recently Adopted Effective January 1, 2020, the Company early adopted ASU No. 2019-12, Income Taxes (Topic 740)—Simplifying the Accounting for Income Taxes (ASU 2019-12). ASU 2019-12 removes the exception to the incremental approach of intra-period tax allocation when there is a loss from continuing operations and income or gain from other items (for example, other comprehensive income). ASU 2019-12 is effective for annual periods, and interim periods within those annual periods, beginning after December 15, 2020. Early adoption is permitted, including adoption in an interim period. The Company elected to early adopt ASU 2019-12. By early adopting, ASU 2019-12 is effective for the Company beginning January 1, 2020. There is no cumulative effect to be recognized in connection with the early adoption of ASU 2019-12 and the adoption did not have a material impact on the Company’s financial statements or disclosures. |
Available-for-Sale Securities
Available-for-Sale Securities | 3 Months Ended |
Mar. 31, 2020 | |
Investments Debt And Equity Securities [Abstract] | |
Available-for-Sale Securities | 3. Available-for-Sale Securities The Company invests in available-for-sale debt securities consisting of money market funds, certificates of deposit, U.S. Treasury securities and U.S. government sponsored enterprise securities. Available-for-sale debt securities are classified as part of either cash and cash equivalents or short-term investments in the condensed balance sheets. Available-for-sale debt securities with maturities of three months or less from the date of purchase have been classified as cash equivalents, and were $28.4 million and $22.1 million as of March 31, 2020 and December 31, 2019 respectively. Available-for-sale debt securities with maturities of more than three months from the date of purchase have been classified as short-term investments, and were as follows (in thousands): Amortized Cost Unrealized Gains Unrealized Losses Market Value March 31, 2020: U.S. Treasury securities $ 17,504 $ 64 $ — $ 17,568 $ 17,504 $ 64 $ — $ 17,568 December 31, 2019: U.S. Treasury securities $ 35,465 $ 16 $ (5 ) $ 35,476 $ 35,465 $ 16 $ (5 ) $ 35,476 As of March 31, 2020, the Company had no securities in a gross unrealized loss position. At each reporting date, the Company performs an evaluation of impairment to determine if any unrealized losses are other-than-temporary. Factors considered in determining whether a loss is other-than-temporary include the length of time and extent to which fair value has been less than the cost basis, the financial condition of the issuer, and the Company’s intent and ability to hold the investment until recovery of its amortized cost basis. Otonomy intends and has the ability, to hold any investments in unrealized loss positions until their amortized cost basis has been recovered. The Company obtains the fair value of its available-for-sale debt securities from a professional pricing service. The fair values of available-for-sale debt securities are validated by comparing the fair values reported by the professional pricing service to quoted market prices or to fair values obtained from the custodian bank. |
Balance Sheet Details
Balance Sheet Details | 3 Months Ended |
Mar. 31, 2020 | |
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): March 31, December 31, 2020 2019 Prepaid clinical trial costs $ 147 $ 209 Other 2,052 2,271 Total $ 2,199 $ 2,480 Property and Equipment, Net Property and equipment is recorded at cost and depreciated using the straight-line method over the estimated useful lives of the assets (generally two 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. The Company assesses the value of its long-lived assets for impairment on an annual basis and whenever events indicate that the carrying amount of such assets may not be recoverable. No such impairment was recorded during the three months ended March 31, 2020 and 2019. Property and equipment, net is comprised of the following (in thousands): March 31, December 31, 2020 2019 Laboratory equipment $ 4,179 $ 4,179 Manufacturing equipment 1,116 1,111 Computer equipment and software 935 943 Leasehold improvements 768 768 Office furniture 1,548 1,548 8,546 8,549 Less: accumulated depreciation (5,133 ) (4,847 ) Total $ 3,413 $ 3,702 Accrued Expenses The Company estimates expenses resulting from its obligations under contracts with vendors, contract research organizations (CROs) and consultants and under clinical site agreements in connection with conducting clinical trials. The financial terms of these contracts vary and may result in payment flows that do not match the periods over which materials or services are provided. The Company records clinical trial expenses in the period in which services are performed and efforts are expended. The Company accrues 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 estimates accruals through financial models taking into account discussion with applicable personnel and outside service providers as to the progress of trials. During the course of a clinical trial, the Company may adjust its clinical accruals if actual results differ from its estimates. Accrued expenses are comprised of the following (in thousands): March 31, December 31, 2020 2019 Accrued clinical trial costs $ 3,037 $ 3,443 Accrued other 1,475 1,999 Total $ 4,512 $ 5,442 |
Commitments and Contingencies
Commitments and Contingencies | 3 Months Ended |
Mar. 31, 2020 | |
Commitments And Contingencies Disclosure [Abstract] | |
Commitments and Contingencies | 5. Commitments and Contingencies Intellectual Property Licenses The Company has acquired exclusive rights to develop patented rights, information rights and related know-how for OTIPRIO, OTIVIDEX, OTO-311, OTO-313 and OTO-413 and potential future product candidates under licensing agreements with third parties. The licensing rights obligate the Company to make payments to the licensors for license fees, milestones and royalties. The Company is also responsible for patent prosecution costs, in the event such costs are incurred. The Company may be obligated to make additional milestone payments under the Company’s intellectual property license agreements as follows (in thousands): Development $ 1,500 Regulatory 10,275 Commercialization 1,000 Total $ 12,775 Under one of these agreements, the Company has achieved seven development milestones and one regulatory milestone, totaling $2.9 million, related to its clinical trials for OTIPRIO, OTIVIDEX, OTO-311 and OTO-413. In addition, the Company is obligated to pay royalties of less than five percent on net sales of OTIPRIO and on sales of any other commercial products developed using these licensed technologies. Such royalty expense for OTIPRIO is recorded to cost of product sales. 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 March 31, 2020, the Company has not entered into any sublicense agreements for the licensed technologies. Other Royalty Arrangements The Company entered into an agreement related to OTIPRIO under which the Company is obligated to pay royalties of less than one percent on net product sales of OTIPRIO. The royalties are recorded as selling, general and administrative expense. 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. In October 2014, the Company entered into an exclusive license agreement with Ipsen that enables the Company to use clinical and nonclinical gacyclidine data generated by Ipsen to support worldwide development and regulatory filings for OTO-313. Under this license agreement, the Company is obligated to pay Ipsen low single-digit royalties on annual net sales of OTO-313 by the Company or its affiliates or sublicensees, up to a maximum cumulative royalty totaling $10.0 million. |
Fair Value
Fair Value | 3 Months Ended |
Mar. 31, 2020 | |
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 : Observable inputs such as quoted prices in active markets for identical assets or liabilities. Level : Inputs other than quoted prices in active markets that are observable either directly or indirectly. Level : Unobservable inputs in which there is little or no market data, which require the reporting entity to develop its own assumptions. As of March 31, 2020 and December 31, 2019 the Company held no assets or liabilities measured at fair value on a nonrecurring basis and no liabilities measured at fair value on a recurring basis. The following fair value hierarchy table presents the Company’s assets measured at fair value on a recurring basis (in thousands): Fair Value Measurement at Reporting Date Using Total Level 1 Level 2 Level 3 March 31, 2020: Assets Money market funds $ 28,355 $ 28,355 $ — $ — U.S. Treasury securities 17,568 17,568 — — $ 45,923 $ 45,923 $ — $ — December 31, 2019: Assets Money market funds $ 22,121 $ 22,121 $ — $ — U.S. Treasury securities 35,476 35,476 — — $ 57,597 $ 57,597 $ — $ — |
Leases
Leases | 3 Months Ended |
Mar. 31, 2020 | |
Leases [Abstract] | |
Leases | 7. Leases Operating Leases Effective January 1, 2019, the Company adopted ASC 842, Leases (ASC 842), using the modified retrospective approach for leases existing as of the period of adoption. The Company utilized the available practical expedients, allowing it to, among other things, carry forward its historical assessment of whether existing agreements are or contain a lease and the classification of existing lease agreements. The right-of-use (ROU) assets associated with all the Company’s operating leases are recognized in the condensed balance sheets. The Company has existing operating leases for certain office equipment and its facility with initial terms ranging from 48 months to 130 months. The facility lease has an option for the Company to extend the lease term for an additional five years; however, it is not reasonably certain the Company will exercise the option to renew when the lease term ends in 2027, and thus, the incremental term was excluded from the calculation of the lease liability. The Company has the right to terminate the lease at the end of the 94th month of the lease term if it is acquired by a third party and pays an early termination fee. The Company’s restricted cash consists of cash maintained in separate deposit accounts to secure a letter of credit issued by a bank to the landlord under the facility lease. On March 31, 2019, the Company entered into a lease for certain equipment with an initial term of 24 months, which includes a purchase option at the end of the lease term based upon the then fair market value of the equipment. The lease payment includes customary principal and interest as well as costs related to the installation and setup of the equipment. The Company evaluated the lease in accordance with ASC 842 and recorded this lease as an operating lease in the condensed balance sheets. Finance Leases On March 31, 2019, the Company entered into a lease for certain computer equipment with an initial term of 24 months, which includes an option to purchase the equipment at the end of the lease term that is expected to be exercised. The lease payment includes customary principal and interest as well as costs related to the installation and setup of the equipment. The associated ROU asset is recognized within property and equipment, net in the condensed balance sheets and is being amortized over three years in accordance with the Company’s standard depreciation and amortization policies. Three Months Ended March 31, Lease expenses: 2020 2019 Operating lease expenses $ 784 $ 784 Variable lease expenses 145 307 Total lease expenses $ 929 $ 1,091 March 31, 2020 Other information: Cash paid for amounts included in the measurement of lease liabilities: Operating cash flows from operating leases $ 29 Weighted-average remaining lease term: Operating leases 7.5 years Finance leases 1.0 years Weighted-average remaining discount rate: Operating leases 10.0 % Finance leases 9.2 % Lease Maturities: Operating Leases Finance Leases Total Remaining in 2020 $ 2,423 $ 56 $ 2,479 2021 3,247 18 3,265 2022 3,333 — 3,333 2023 3,433 — 3,433 2024 3,536 — 3,536 2025 3,642 — 3,642 Thereafter 6,642 — 6,642 Total minimum lease payments 26,256 74 26,330 Imputed interest (8,067 ) (4 ) (8,071 ) Total 18,189 70 18,259 Less: leases, current (3,238 ) (70 ) (3,308 ) Leases, net of current $ 14,951 $ - $ 14,951 |
Long-term Debt
Long-term Debt | 3 Months Ended |
Mar. 31, 2020 | |
Long Term Debt [Abstract] | |
Long-term Debt | 8. Long-term Debt On December 31, 2018 (the Closing Date), the Company entered into a Loan and Security Agreement (the Loan Agreement), among the Company, Oxford Finance LLC, as collateral agent, and the lenders party thereto from time to time. The Loan Agreement provides for a $15.0 million secured term loan credit facility (the Term Loan). The proceeds of the Term Loan may be used for working capital and general corporate purposes. The Company has the right to prepay the Term Loan in whole or in part at any time, subject to a prepayment fee of 3.00% if prepaid on or prior to the first anniversary of the Closing Date, 2.00% if prepaid after the first anniversary of the Closing Date and on or prior to the second anniversary of the Closing Date, and 1.00% thereafter. Amounts prepaid or repaid under the Term Loan may not be reborrowed. The Term Loan was fully funded on the Closing Date and matures on December 1, 2023 (the Maturity Date). The Company paid a facility fee of 0.75% and customary closing fees on the Closing Date. The Term Loan bears interest at a floating rate equal to the greater of 5.25% and the prime rate as reported in the Wall Street Journal from time to time, plus 3.75% (9.0% as of March 31, 2020, the minimum interest rate). Interest on the Term Loan is payable monthly in arrears. The Company is permitted to make interest-only payments on the Term Loan for the twenty-four (24) months following the Closing Date followed by consecutive equal monthly payments of principal and interest in arrears through the Maturity Date. The interest-only period can be extended by an additional twelve (12) months subject to the achievement of a certain clinical trial milestone. The outstanding principal amount of the Term Loan, together with accrued and unpaid interest, is due on December 1, 2023. Upon repayment or acceleration of the Term Loan, a final payment fee equal to 4.00% of the aggregate original principal amount of the Term Loan is payable (the Final Payment). The Final Payment of $0.6 million, as well as the initial facility fee and all other direct fees and costs associated with the Loan Agreement, was recognized as a debt discount. The debt discount will be amortized to interest expense over the term of the Loan Agreement using the effective interest method. The Company’s obligations under the Loan Agreement are secured by substantially all its assets, excluding intellectual property and subject to certain other exceptions and limitations. The Loan Agreement contains customary affirmative covenants, including covenants regarding compliance with applicable laws and regulations, reporting requirements, payment of taxes and other obligations, and maintenance of insurance. Further, subject to certain exceptions, the Loan Agreement contains customary negative covenants limiting the ability of the Company to, among other things, sell assets, allow a change of control to occur (if the Term Loan is not repaid), make acquisitions, incur debt, grant liens, make investments, pay dividends or repurchase stock. The Company has maintained compliance with all such covenants to date. Upon the occurrence and during the continuance of an event of default, the lenders may declare all outstanding principal and accrued and unpaid interest under the Loan Agreement immediately due and payable, increase the applicable rate of interest by 5.00%, and exercise the other rights and remedies provided for under the Loan Agreement and related loan documents. The events of default under the Loan Agreement include payment defaults, breaches of covenants or representations and warranties, material adverse changes, certain bankruptcy events, cross defaults with certain other indebtedness, and judgment defaults. Interest expense, including amortization of the debt discount, related to the Loan Agreement totaled $0.4 million for the three months ended March 31, 2020 and 2019. Accrued interest, included in accounts payable, was $0.1 million as of March 31, 2020 and December 31, 2019. The outstanding Term Loan balance was $15.0 million as of March 31, 2020 and December 31, 2019, inclusive of accretion of the final payment and net unamortized debt discount. |
Stockholders' Equity
Stockholders' Equity | 3 Months Ended |
Mar. 31, 2020 | |
Equity [Abstract] | |
Stockholders' Equity | 9. Stockholders’ Equity Common Stock Reserved for Future Issuance Shares of common stock reserved for future issuance are as follows: March 31, December 31, 2020 2019 Common stock options issued and outstanding 10,052,847 7,495,129 Common stock options available for future grant 2,531,206 3,548,214 Common stock reserved for issuance under ESPP 2,439,428 1,977,215 Total common stock reserved for future issuance 15,023,481 13,020,558 Net Loss Per Share As of March 31, 2020 and 2019, potentially dilutive securities excluded from the calculation of diluted net loss per share consist of outstanding options to purchase 10,052,847 and 7,346,935 shares of the Company’s common stock, respectively. |
Stock-Based Compensation
Stock-Based Compensation | 3 Months Ended |
Mar. 31, 2020 | |
Disclosure Of Compensation Related Costs Sharebased Payments [Abstract] | |
Stock-Based Compensation | 10. Stock-Based Compensation The 2014 Equity Incentive Plan (the 2014 Plan) permits the grant of incentive stock options to the Company’s employees and 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. Options granted under the 2014 Plan are generally scheduled to vest over four years, subject to continued service, and subject to certain acceleration of vesting provisions, expire no later than 10 years from the date of grant. Options granted under the 2014 Plan must 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. 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. Forfeitures are recognized as incurred. For awards subject to time-based vesting conditions, stock-based compensation expense is recognized using the straight-line method. The following table summarizes stock option activity for the three months ended March 31, 2020 (share amounts in thousands): Options Weighted- Average Exercise Price Outstanding as of December 31, 2019 7,495 $ 4.43 Granted 2,850 $ 3.51 Exercised — $ — Forfeited (292 ) $ 3.50 Outstanding as of March 31, 2020 10,053 $ 4.19 Total non-cash stock-based compensation expense recognized in the accompanying condensed statements of operations is as follows (in thousands): Three Months Ended March 31, 2020 2019 Cost of product sales $ 5 $ 3 Research and development 568 659 Selling, general and administrative 841 834 Total stock-based compensation $ 1,414 $ 1,496 |
Collaboration Agreements
Collaboration Agreements | 3 Months Ended |
Mar. 31, 2020 | |
Collaborative Arrangement Disclosure [Abstract] | |
Collaboration Agreements | 11. Collaboration Agreements AGTC collaboration In October 2019, the Company announced a strategic collaboration with AGTC to co-develop and co-commercialize an adeno-associated virus (AAV)-based gene therapy to restore hearing in patients with sensorineural hearing loss caused by a mutation in the gap junction beta 2 gene (GJB2). Under the collaboration agreement, the Company and AGTC will equally share the program costs and any revenue or other proceeds related to the program. For the three months ended March 31, 2020, the Company recognized research and development expenses related to the AGTC collaboration of $0.1 million. Co-Promotion Agreements The Company entered into a co-promotion agreement with Mission Pharmacal Company (Mission) in August 2018 and with Glenmark Therapeutics Inc., USA (Glenmark) in April 2019 (each, a Co-Promotion Agreement) to support the promotion of OTIPRIO for the treatment of AOE in physician offices. In July 2019, Glenmark informed the Company of its early discontinuation of OTIPRIO promotional support activities due to the delay in FDA approval of its Ryaltris™ allergy product, and the impact of such delay on its business operations. In September 2019, the Company reached a settlement with Glenmark regarding the financial and contractual terms impacted by this decision that included committed payments by Glenmark totaling $1.0 million. In August 2019, Mission informed the Company of its non-renewal of the co-promotion agreement. The Co-Promotion Agreements are within the scope of ASC Topic 808, Collaborative Arrangements 50 The Company does not consider performing product support services for its Partners to be a part of its ongoing major or central operations and, thus, the associated payments are not considered revenue, nor do they fall under ASC 606. The Company considers these activities to be collaborative activities under the scope of ASC 808, and recognizes the shared profits and losses in the periods in which they occurred. For the three months ended March 31, 2020 and 2019, the Company recognized reductions in selling, general and administrative expenses related to the Co-Promotion Agreements of $0.0 million and $0.4 million. |
Subsequent Events
Subsequent Events | 3 Months Ended |
Mar. 31, 2020 | |
Subsequent Events [Abstract] | |
Subsequent Events | 12. Subsequent Events On April 10, 2020 the Company obtained an unsecured $1.1 million loan through JPMorgan Chase Bank, N.A. under the Paycheck Protection Program (the PPP Loan) pursuant to the Coronavirus Aid, Relief, and Economic Security (CARES) Act. The PPP Loan bore an interest rate of 0.98% and notionally matured two years from the date of issuance. Following the issuance of new, retroactive guidance on the program from the Small Business Administration on April 23, 2020, the Company repaid the PPP Loan and accrued interest in full. |
Description of Business and B_2
Description of Business and Basis of Presentation (Policies) | 3 Months Ended |
Mar. 31, 2020 | |
Accounting Policies [Abstract] | |
Liquidity and Financial Condition | Liquidity and Financial Condition The Company follows Accounting Standards Codification (ASC) Topic 205-40, Presentation of Financial Statements—Going Concern The 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 March 31, 2020, the Company had cash, cash equivalents and short-term investments of $48.6 million and an accumulated deficit of $471.7 million. The Company anticipates that it will continue to incur net losses into the foreseeable future as it: (i) develops and seeks regulatory approvals for OTIVIDEX and its other product candidates; and (ii) works to develop additional product candidates through research and development programs. The Company intends to seek additional funding through future debt and/or equity financings or other sources, such as potential collaboration agreements. Additional capital may not be available in sufficient amounts or on reasonable terms, if at all. If the Company is not able to secure adequate additional funding, if or when necessary, 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. The Company believes that its existing cash, cash equivalents and short-term investments that include proceeds from its long-term debt will be sufficient to fund its operations for a period of at least twelve months from the date of this report. |
Basis of Presentation | Basis of Presentation 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 the Company’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, results of operations and cash flows for the periods presented. These condensed financial 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, 2019 included in the Company’s Annual Report on Form 10-K, as filed with the SEC on February 27, 2020. 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 condensed financial statements have been prepared in accordance with GAAP. The preparation of financial statements in conformity with GAAP requires the Company 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 product sales and expense during the reporting period. Although these estimates are based on the Company’s knowledge of current events and anticipated actions it may undertake in the future, actual results may ultimately materially differ from these estimates and assumptions. |
Short-term Investments | Short-term Investments The Company carries short-term investments classified as available-for-sale debt securities 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 – Fair Value 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. The Company records unrealized gains and losses on available-for-sale debt securities as a component of other comprehensive loss within the condensed statements of comprehensive loss and as a separate component of stockholders’ equity on the condensed balance sheets. The Company does not hold equity securities in its investment portfolio. |
Fair Value of Financial Instruments | Fair Value of Financial Instruments The Company’s financial instruments include cash, cash equivalents, short-term investments, prepaid expenses and other assets, accounts payable, accrued expenses, accrued compensation and long-term debt. The carrying value of the Company’s cash and cash equivalents, short-term investments, prepaid expenses and other current assets, other long-term assets, accounts payable, accrued expenses, and accrued compensation approximate fair value due to the short-term nature of these items. Based on Level 3 inputs and the borrowing rates currently available for loans with similar terms, the Company believes the fair value of long-term debt approximates its carrying value. |
Risks and Uncertainties Related to COVID-19 | Risks and Uncertainties Related to COVID-19 In March 2020, the World Health Organization declared coronavirus COVID-19 a global pandemic. The COVID-19 pandemic could pose significant risks to the Company’s business; however, the ultimate impact of the pandemic is highly uncertain. The Company does not yet know the full extent of potential delays or impacts on its business, its preclinical programs and clinical trials, healthcare systems or the global economy as a whole. As such, it is uncertain as to the full magnitude that the COVID-19 pandemic will have on the Company’s financial condition, liquidity and future results of operations. |
Recent Accounting Pronouncements | Recent Accounting Pronouncements Not Yet Adopted In June 2016, Accounting Standards Update (ASU) No. 2016-13, Financial Instruments—Credit Losses (Topic 326): Measurement of Credit Losses on Financial Instruments . Recently Adopted Effective January 1, 2020, the Company early adopted ASU No. 2019-12, Income Taxes (Topic 740)—Simplifying the Accounting for Income Taxes (ASU 2019-12). ASU 2019-12 removes the exception to the incremental approach of intra-period tax allocation when there is a loss from continuing operations and income or gain from other items (for example, other comprehensive income). ASU 2019-12 is effective for annual periods, and interim periods within those annual periods, beginning after December 15, 2020. Early adoption is permitted, including adoption in an interim period. The Company elected to early adopt ASU 2019-12. By early adopting, ASU 2019-12 is effective for the Company beginning January 1, 2020. There is no cumulative effect to be recognized in connection with the early adoption of ASU 2019-12 and the adoption did not have a material impact on the Company’s financial statements or disclosures. |
Available-for-Sale Securities (
Available-for-Sale Securities (Tables) | 3 Months Ended |
Mar. 31, 2020 | |
Investments Debt And Equity Securities [Abstract] | |
Schedule of Available-for-Sale Debt Securities | Available-for-sale debt securities with maturities of more than three months from the date of purchase have been classified as short-term investments, and were as follows (in thousands): Amortized Cost Unrealized Gains Unrealized Losses Market Value March 31, 2020: U.S. Treasury securities $ 17,504 $ 64 $ — $ 17,568 $ 17,504 $ 64 $ — $ 17,568 December 31, 2019: U.S. Treasury securities $ 35,465 $ 16 $ (5 ) $ 35,476 $ 35,465 $ 16 $ (5 ) $ 35,476 |
Balance Sheet Details (Tables)
Balance Sheet Details (Tables) | 3 Months Ended |
Mar. 31, 2020 | |
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): March 31, December 31, 2020 2019 Prepaid clinical trial costs $ 147 $ 209 Other 2,052 2,271 Total $ 2,199 $ 2,480 |
Property and Equipment, Net | Property and equipment, net is comprised of the following (in thousands): March 31, December 31, 2020 2019 Laboratory equipment $ 4,179 $ 4,179 Manufacturing equipment 1,116 1,111 Computer equipment and software 935 943 Leasehold improvements 768 768 Office furniture 1,548 1,548 8,546 8,549 Less: accumulated depreciation (5,133 ) (4,847 ) Total $ 3,413 $ 3,702 |
Accrued Expenses | Accrued expenses are comprised of the following (in thousands): March 31, December 31, 2020 2019 Accrued clinical trial costs $ 3,037 $ 3,443 Accrued other 1,475 1,999 Total $ 4,512 $ 5,442 |
Commitments and Contingencies (
Commitments and Contingencies (Tables) | 3 Months Ended |
Mar. 31, 2020 | |
Commitments And Contingencies Disclosure [Abstract] | |
Schedule of Additional Milestone Payments under Intellectual Property License Agreements | The Company may be obligated to make additional milestone payments under the Company’s intellectual property license agreements as follows (in thousands): Development $ 1,500 Regulatory 10,275 Commercialization 1,000 Total $ 12,775 |
Fair Value (Tables)
Fair Value (Tables) | 3 Months Ended |
Mar. 31, 2020 | |
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 (in thousands): Fair Value Measurement at Reporting Date Using Total Level 1 Level 2 Level 3 March 31, 2020: Assets Money market funds $ 28,355 $ 28,355 $ — $ — U.S. Treasury securities 17,568 17,568 — — $ 45,923 $ 45,923 $ — $ — December 31, 2019: Assets Money market funds $ 22,121 $ 22,121 $ — $ — U.S. Treasury securities 35,476 35,476 — — $ 57,597 $ 57,597 $ — $ — |
Leases (Tables)
Leases (Tables) | 3 Months Ended |
Mar. 31, 2020 | |
Leases [Abstract] | |
Summary of Lease Expenses | Three Months Ended March 31, Lease expenses: 2020 2019 Operating lease expenses $ 784 $ 784 Variable lease expenses 145 307 Total lease expenses $ 929 $ 1,091 |
Summary of Other Information | March 31, 2020 Other information: Cash paid for amounts included in the measurement of lease liabilities: Operating cash flows from operating leases $ 29 Weighted-average remaining lease term: Operating leases 7.5 years Finance leases 1.0 years Weighted-average remaining discount rate: Operating leases 10.0 % Finance leases 9.2 % |
Future Minimum Annual Obligations under Finance and Operating Lease Commitments | Lease Maturities: Operating Leases Finance Leases Total Remaining in 2020 $ 2,423 $ 56 $ 2,479 2021 3,247 18 3,265 2022 3,333 — 3,333 2023 3,433 — 3,433 2024 3,536 — 3,536 2025 3,642 — 3,642 Thereafter 6,642 — 6,642 Total minimum lease payments 26,256 74 26,330 Imputed interest (8,067 ) (4 ) (8,071 ) Total 18,189 70 18,259 Less: leases, current (3,238 ) (70 ) (3,308 ) Leases, net of current $ 14,951 $ - $ 14,951 |
Stockholders' Equity (Tables)
Stockholders' Equity (Tables) | 3 Months Ended |
Mar. 31, 2020 | |
Equity [Abstract] | |
Schedule of Shares of Common Stock Reserved for Future Issuance | Shares of common stock reserved for future issuance are as follows: March 31, December 31, 2020 2019 Common stock options issued and outstanding 10,052,847 7,495,129 Common stock options available for future grant 2,531,206 3,548,214 Common stock reserved for issuance under ESPP 2,439,428 1,977,215 Total common stock reserved for future issuance 15,023,481 13,020,558 |
Stock-Based Compensation (Table
Stock-Based Compensation (Tables) | 3 Months Ended |
Mar. 31, 2020 | |
Disclosure Of Compensation Related Costs Sharebased Payments [Abstract] | |
Stock Option Activity | The following table summarizes stock option activity for the three months ended March 31, 2020 (share amounts in thousands): Options Weighted- Average Exercise Price Outstanding as of December 31, 2019 7,495 $ 4.43 Granted 2,850 $ 3.51 Exercised — $ — Forfeited (292 ) $ 3.50 Outstanding as of March 31, 2020 10,053 $ 4.19 |
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 March 31, 2020 2019 Cost of product sales $ 5 $ 3 Research and development 568 659 Selling, general and administrative 841 834 Total stock-based compensation $ 1,414 $ 1,496 |
Description of Business and B_3
Description of Business and Basis of Presentation - Additional Information (Detail) - USD ($) $ in Thousands | Mar. 31, 2020 | Dec. 31, 2019 |
Organization Consolidation And Presentation Of Financial Statements [Abstract] | ||
Cash, cash equivalents and short-term investments | $ 48,600 | |
Accumulated deficit | $ (471,656) | $ (459,893) |
Available-for-Sale Securities -
Available-for-Sale Securities - Additional Information (Detail) | 3 Months Ended | |
Mar. 31, 2020USD ($)Security | Dec. 31, 2019USD ($) | |
Schedule of Available-for-sale Securities [Line Items] | ||
Number of available-for-sale securities in unrealized loss positions for less than twelve months | Security | 0 | |
Other-than-temporary declines in the value of any available-for-sale securities | $ 0 | |
Maximum maturity of available-for-sale debt securities | 1 year | |
Available-for-sale Securities [Member] | Money Market Funds and Certificates of Deposit [Member] | ||
Schedule of Available-for-sale Securities [Line Items] | ||
Cash equivalents | $ 28,400,000 | $ 22,100,000 |
Available-for-Sale Securities_2
Available-for-Sale Securities - Schedule of Available-for-Sale Debt Securities (Detail) - USD ($) $ in Thousands | 3 Months Ended | 12 Months Ended |
Mar. 31, 2020 | Dec. 31, 2019 | |
Schedule of Available-for-sale Securities [Line Items] | ||
Amortized Cost | $ 17,504 | $ 35,465 |
Unrealized Gains | 64 | 16 |
Unrealized Losses | 0 | (5) |
Market Value | 17,568 | 35,476 |
U.S. Treasury Securities [Member] | ||
Schedule of Available-for-sale Securities [Line Items] | ||
Amortized Cost | 17,504 | 35,465 |
Unrealized Gains | 64 | 16 |
Unrealized Losses | 0 | (5) |
Market Value | $ 17,568 | $ 35,476 |
Balance Sheet Details - Prepaid
Balance Sheet Details - Prepaid and Other Current Assets (Detail) - USD ($) $ in Thousands | Mar. 31, 2020 | Dec. 31, 2019 |
Deferred Costs Capitalized Prepaid And Other Assets Disclosure [Abstract] | ||
Prepaid clinical trial costs | $ 147 | $ 209 |
Other | 2,052 | 2,271 |
Total | $ 2,199 | $ 2,480 |
Balance Sheet Details - Propert
Balance Sheet Details - Property and Equipment, Net - Additional Information (Detail) - USD ($) | 3 Months Ended | |
Mar. 31, 2020 | Mar. 31, 2019 | |
Property, Plant and Equipment [Line Items] | ||
Impairment of long-lived assets | $ 0 | $ 0 |
Minimum [Member] | ||
Property, Plant and Equipment [Line Items] | ||
Property and equipment useful lives | 2 years | |
Maximum [Member] | ||
Property, Plant and Equipment [Line Items] | ||
Property and equipment useful lives | 10 years |
Balance Sheet Details - Prope_2
Balance Sheet Details - Property and Equipment, Net (Detail) - USD ($) $ in Thousands | Mar. 31, 2020 | Dec. 31, 2019 |
Property, Plant and Equipment [Line Items] | ||
Property and equipment, gross | $ 8,546 | $ 8,549 |
Less: accumulated depreciation | (5,133) | (4,847) |
Total | 3,413 | 3,702 |
Laboratory Equipment [Member] | ||
Property, Plant and Equipment [Line Items] | ||
Property and equipment, gross | 4,179 | 4,179 |
Manufacturing Equipment [Member] | ||
Property, Plant and Equipment [Line Items] | ||
Property and equipment, gross | 1,116 | 1,111 |
Computer Equipment and Software [Member] | ||
Property, Plant and Equipment [Line Items] | ||
Property and equipment, gross | 935 | 943 |
Leasehold Improvements [Member] | ||
Property, Plant and Equipment [Line Items] | ||
Property and equipment, gross | 768 | 768 |
Office Furniture [Member] | ||
Property, Plant and Equipment [Line Items] | ||
Property and equipment, gross | $ 1,548 | $ 1,548 |
Balance Sheet Details - Accrued
Balance Sheet Details - Accrued Expenses (Detail) - USD ($) $ in Thousands | Mar. 31, 2020 | Dec. 31, 2019 |
Payables And Accruals [Abstract] | ||
Accrued clinical trial costs | $ 3,037 | $ 3,443 |
Accrued other | 1,475 | 1,999 |
Total | $ 4,512 | $ 5,442 |
Commitments and Contingencies -
Commitments and Contingencies - Schedule of Additional Milestone Payments under Intellectual Property License Agreements (Detail) $ in Thousands | Mar. 31, 2020USD ($) |
Other Commitments [Line Items] | |
Cash Payments | $ 12,775 |
Development [Member] | |
Other Commitments [Line Items] | |
Cash Payments | 1,500 |
Regulatory [Member] | |
Other Commitments [Line Items] | |
Cash Payments | 10,275 |
Commercialization [Member] | |
Other Commitments [Line Items] | |
Cash Payments | $ 1,000 |
Commitments and Contingencies_2
Commitments and Contingencies - Additional Information (Detail) | 3 Months Ended | |
Mar. 31, 2020USD ($)Milestone | Oct. 31, 2014USD ($) | |
Intellectual Property [Member] | ||
Other Commitments [Line Items] | ||
Milestone fees | $ | $ 2,900,000 | |
Maximum percentage of royalties on sales | 5.00% | |
Intellectual Property [Member] | Regulatory [Member] | ||
Other Commitments [Line Items] | ||
Number of milestones achieved | Milestone | 1 | |
Intellectual Property [Member] | Development [Member] | ||
Other Commitments [Line Items] | ||
Number of milestones achieved | Milestone | 7 | |
Royalty Agreements [Member] | ||
Other Commitments [Line Items] | ||
Maximum percentage of royalties on sales | 1.00% | |
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-313 by the Company or its affiliates or sublicensees | |
Maximum cumulative royalties paid under license agreement | $ | $ 10,000,000 |
Fair Value - Additional informa
Fair Value - Additional information (Detail) - USD ($) | Mar. 31, 2020 | Dec. 31, 2019 |
Fair Value Measurements Nonrecurring [Member] | ||
Fair Value Assets And Liabilities Measured On Recurring And Nonrecurring Basis [Line Items] | ||
Assets measured at fair value | $ 0 | $ 0 |
Liabilities measured at fair value | 0 | 0 |
Fair Value Measurements, Recurring [Member] | ||
Fair Value Assets And Liabilities Measured On Recurring And Nonrecurring Basis [Line Items] | ||
Assets measured at fair value | 45,923,000 | 57,597,000 |
Liabilities measured at fair value | $ 0 | $ 0 |
Fair Value - Fair Value Assets
Fair Value - Fair Value Assets Measured on a Recurring Basis (Detail) - USD ($) $ in Thousands | Mar. 31, 2020 | Dec. 31, 2019 |
Assets | ||
Short-term investments | $ 17,568 | $ 35,476 |
U.S. Treasury Securities [Member] | ||
Assets | ||
Short-term investments | 17,568 | 35,476 |
Fair Value Measurements, Recurring [Member] | ||
Assets | ||
Total assets | 45,923 | 57,597 |
Fair Value Measurements, Recurring [Member] | Money Market Funds [Member] | ||
Assets | ||
Money market funds | 28,355 | 22,121 |
Fair Value Measurements, Recurring [Member] | U.S. Treasury Securities [Member] | ||
Assets | ||
Short-term investments | 17,568 | 35,476 |
Level 1 [Member] | Fair Value Measurements, Recurring [Member] | ||
Assets | ||
Total assets | 45,923 | 57,597 |
Level 1 [Member] | Fair Value Measurements, Recurring [Member] | Money Market Funds [Member] | ||
Assets | ||
Money market funds | 28,355 | 22,121 |
Level 1 [Member] | Fair Value Measurements, Recurring [Member] | U.S. Treasury Securities [Member] | ||
Assets | ||
Short-term investments | 17,568 | 35,476 |
Level 2 [Member] | Fair Value Measurements, Recurring [Member] | ||
Assets | ||
Total assets | 0 | 0 |
Level 2 [Member] | Fair Value Measurements, Recurring [Member] | Money Market Funds [Member] | ||
Assets | ||
Money market funds | 0 | 0 |
Level 2 [Member] | Fair Value Measurements, Recurring [Member] | U.S. Treasury Securities [Member] | ||
Assets | ||
Short-term investments | 0 | 0 |
Level 3 [Member] | Fair Value Measurements, Recurring [Member] | ||
Assets | ||
Total assets | 0 | 0 |
Level 3 [Member] | Fair Value Measurements, Recurring [Member] | Money Market Funds [Member] | ||
Assets | ||
Money market funds | 0 | 0 |
Level 3 [Member] | Fair Value Measurements, Recurring [Member] | U.S. Treasury Securities [Member] | ||
Assets | ||
Short-term investments | $ 0 | $ 0 |
Leases - Additional Information
Leases - Additional Information (Detail) | 3 Months Ended |
Mar. 31, 2020 | |
Lessee Lease Description [Line Items] | |
Operating lease, description | The Company has existing operating leases for certain office equipment and its facility with initial terms ranging from 48 months to 130 months. |
Operating lease, option to extend | true |
Operating lease, option to extend description | The facility lease has an option for the Company to extend the lease term for an additional five years; however, it is not reasonably certain the Company will exercise the option to renew when the lease term ends in 2027, and thus, the incremental term was excluded from the calculation of the lease liability. |
Additional operating lease term | 5 years |
Operating lease term ending year | 2027 |
Operating lease, option to terminate | true |
Operating lease, option to terminate description | The Company has the right to terminate the lease at the end of the 94th month of the lease term if it is acquired by a third party and pays an early termination fee. |
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 |
Computer Equipment [Member] | |
Lessee Lease Description [Line Items] | |
Operating lease, description | On March 31, 2019, the Company entered into a lease for certain equipment with an initial term of 24 months, which includes a purchase option at the end of the lease term based upon the then fair market value of the equipment. |
Operating lease term | 24 months |
Finance lease, description | On March 31, 2019, the Company entered into a lease for certain computer equipment with an initial term of 24 months, which includes an option to purchase the equipment at the end of the lease term that is expected to be exercised. |
Finance lease initial term | 24 months |
Finance lease right-of-use asset amortization term | 3 years |
Minimum [Member] | |
Lessee Lease Description [Line Items] | |
Operating lease term | 48 months |
Maximum [Member] | |
Lessee Lease Description [Line Items] | |
Operating lease term | 130 months |
Leases - Summary of Lease Expen
Leases - Summary of Lease Expenses (Detail) - USD ($) $ in Thousands | 3 Months Ended | |
Mar. 31, 2020 | Mar. 31, 2019 | |
Lease expenses: | ||
Operating lease expenses | $ 784 | $ 784 |
Variable lease expenses | 145 | 307 |
Total lease expenses | $ 929 | $ 1,091 |
Leases - Summary of Other Infor
Leases - Summary of Other Information (Detail) $ in Thousands | 3 Months Ended |
Mar. 31, 2020USD ($) | |
Cash paid for amounts included in the measurement of lease liabilities: | |
Operating cash flows from operating leases | $ 29 |
Weighted-average remaining lease term: | |
Operating leases | 7 years 6 months |
Finance leases | 1 year |
Weighted-average remaining discount rate: | |
Operating leases | 10.00% |
Finance leases | 9.20% |
Leases - Future Minimum Annual
Leases - Future Minimum Annual Obligations under Finance and Operating Lease Commitments (Detail) - USD ($) $ in Thousands | Mar. 31, 2020 | Dec. 31, 2019 |
Leases [Abstract] | ||
Operating Leases, Remaining in 2020 | $ 2,423 | |
Operating Leases, 2021 | 3,247 | |
Operating Leases, 2022 | 3,333 | |
Operating Leases, 2023 | 3,433 | |
Operating Leases, 2024 | 3,536 | |
Operating Leases, 2025 | 3,642 | |
Operating Leases, Thereafter | 6,642 | |
Operating Leases, Total minimum lease payments | 26,256 | |
Operating Leases, Imputed interest | (8,067) | |
Operating Leases, Total | 18,189 | |
Operating Leases, Less: leases, current | (3,238) | |
Operating Leases, Leases, net of current | 14,951 | |
Finance Leases, Remaining in 2020 | 56 | |
Finance Leases, 2021 | 18 | |
Finance Leases, 2022 | 0 | |
Finance Leases, 2023 | 0 | |
Finance Leases, 2024 | 0 | |
Finance Leases, 2025 | 0 | |
Finance Leases, Thereafter | 0 | |
Finance Leases, Total minimum lease payments | 74 | |
Finance Leases, Imputed interest | (4) | |
Finance Leases, Total | 70 | |
Finance Leases, Less: leases, current | (70) | |
Finance Leases, Leases, net of current | 0 | |
Remaining in 2020 | 2,479 | |
2021 | 3,265 | |
2022 | 3,333 | |
2023 | 3,433 | |
2024 | 3,536 | |
2025 | 3,642 | |
Thereafter | 6,642 | |
Total minimum lease payments | 26,330 | |
Imputed interest | (8,071) | |
Total | 18,259 | |
Less: leases, current | (3,308) | $ (3,302) |
Leases, net of current | $ 14,951 | $ 15,320 |
Long-term Debt - Additional Inf
Long-term Debt - Additional Information (Detail) - USD ($) $ in Thousands | 3 Months Ended | ||
Mar. 31, 2020 | Mar. 31, 2019 | Dec. 31, 2019 | |
Debt Instrument [Line Items] | |||
Term Loan outstanding | $ 13,731 | $ 14,967 | |
Accounts Payable [Member] | |||
Debt Instrument [Line Items] | |||
Accrued interest | 100 | 100 | |
Secured Term Loan Credit Facility [Member] | |||
Debt Instrument [Line Items] | |||
Debt instrument, face amount | $ 15,000 | ||
Facility fee percentage | 0.75% | ||
Debt instrument, maturity date | Dec. 1, 2023 | ||
Interest rate description | The Term Loan bears interest at a floating rate equal to the greater of 5.25% and the prime rate as reported in the Wall Street Journal from time to time, plus 3.75% (9.0% as of March 31, 2020, the minimum interest rate). | ||
Debt instrument, interest rate at period end | 9.00% | ||
Debt instrument, minimum interest rate | 9.00% | ||
Interest frequency payments | monthly | ||
Interest only payment term | twenty-four (24) months | ||
Interest only payment extension term | twelve (12) months | ||
Repayment fee percentage | 4.00% | ||
Debt discount, amount | $ 600 | ||
Debt instrument, covenant description | The Loan Agreement contains customary affirmative covenants, including covenants regarding compliance with applicable laws and regulations, reporting requirements, payment of taxes and other obligations, and maintenance of insurance. Further, subject to certain exceptions, the Loan Agreement contains customary negative covenants limiting the ability of the Company to, among other things, sell assets, allow a change of control to occur (if the Term Loan is not repaid), make acquisitions, incur debt, grant liens, make investments, pay dividends or repurchase stock. The Company has maintained compliance with all such covenants to date. | ||
Interest expense, including amortization of the debt discount | $ 400 | $ 400 | |
Term Loan outstanding | $ 15,000 | $ 15,000 | |
Secured Term Loan Credit Facility [Member] | Minimum [Member] | |||
Debt Instrument [Line Items] | |||
Debt instrument, reference rate | 5.25% | ||
Debt instrument, basis spread on variable rate | 3.75% | ||
Secured Term Loan Credit Facility [Member] | On or Prior to First Anniversary of Closing Date [Member] | |||
Debt Instrument [Line Items] | |||
Percentage of debt prepayment fee | 3.00% | ||
Secured Term Loan Credit Facility [Member] | After First Anniversary of Closing Date and On or Prior to Second Anniversary of Closing Date [Member] | |||
Debt Instrument [Line Items] | |||
Percentage of debt prepayment fee | 2.00% | ||
Secured Term Loan Credit Facility [Member] | Thereafter Second Anniversary of Closing Date [Member] | |||
Debt Instrument [Line Items] | |||
Percentage of debt prepayment fee | 1.00% | ||
Secured Term Loan Credit Facility [Member] | Occurrence and During Continuance of Event of Default [Member] | |||
Debt Instrument [Line Items] | |||
Increase in applicable rate of interest | 5.00% |
Stockholders' Equity - Schedule
Stockholders' Equity - Schedule of Shares of Common Stock Reserved for Future Issuance (Detail) - shares | Mar. 31, 2020 | Dec. 31, 2019 |
Class of Stock [Line Items] | ||
Total common stock reserved for future issuance | 15,023,481 | 13,020,558 |
Options to Purchase Common Stock [Member] | ||
Class of Stock [Line Items] | ||
Total common stock reserved for future issuance | 10,052,847 | 7,495,129 |
Available Future Grant Year [Member] | Options to Purchase Common Stock [Member] | ||
Class of Stock [Line Items] | ||
Total common stock reserved for future issuance | 2,531,206 | 3,548,214 |
2014 Employee Stock Purchase Plan [Member] | ||
Class of Stock [Line Items] | ||
Total common stock reserved for future issuance | 2,439,428 | 1,977,215 |
Stockholders' Equity - Addition
Stockholders' Equity - Additional Information (Detail) - shares | 3 Months Ended | |
Mar. 31, 2020 | Mar. 31, 2019 | |
Options to Purchase Common Stock [Member] | ||
Class of Stock [Line Items] | ||
Potentially dilutive securities excluded from the calculation of diluted net loss per share | 10,052,847 | 7,346,935 |
Stock-Based Compensation - Addi
Stock-Based Compensation - Additional Information (Detail) - Equity Incentive Plan 2014 [Member] | 3 Months Ended |
Mar. 31, 2020 | |
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |
Share based compensation vesting period | 4 years |
Contractual term of options | 10 years |
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 - Stoc
Stock-Based Compensation - Stock Option Activity (Detail) shares in Thousands | 3 Months Ended |
Mar. 31, 2020$ / sharesshares | |
Options | |
Outstanding as of beginning of period | shares | 7,495 |
Granted | shares | 2,850 |
Exercised | shares | 0 |
Forfeited | shares | (292) |
Outstanding as of end of period | shares | 10,053 |
Weighted- Average Exercise Price | |
Outstanding as of beginning of period | $ / shares | $ 4.43 |
Granted | $ / shares | 3.51 |
Exercised | $ / shares | 0 |
Forfeited | $ / shares | 3.50 |
Outstanding as of end of period | $ / shares | $ 4.19 |
Stock-Based Compensation - Summ
Stock-Based Compensation - Summary of Non-cash Stock Based Compensation Expense (Detail) - USD ($) $ in Thousands | 3 Months Ended | |
Mar. 31, 2020 | Mar. 31, 2019 | |
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||
Total stock-based compensation | $ 1,414 | $ 1,496 |
Cost of Product Sales [Member] | ||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||
Total stock-based compensation | 5 | 3 |
Research and Development [Member] | ||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||
Total stock-based compensation | 568 | 659 |
Selling, General and Administrative [Member] | ||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||
Total stock-based compensation | $ 841 | $ 834 |
Collaboration Agreements - Addi
Collaboration Agreements - Additional information (Detail) - USD ($) $ in Millions | 3 Months Ended | ||
Mar. 31, 2020 | Mar. 31, 2019 | Sep. 30, 2019 | |
AGTC Collaboration [Member] | |||
Collaborative Arrangements And Noncollaborative Arrangement Transactions [Line Items] | |||
Research and development expenses recognized | $ 0.1 | ||
Glenmark Co-Promotion Agreement [Member] | |||
Collaborative Arrangements And Noncollaborative Arrangement Transactions [Line Items] | |||
Payment of committed amount in settlement | $ 1 | ||
Mission Co-Promotion Agreement [Member] | |||
Collaborative Arrangements And Noncollaborative Arrangement Transactions [Line Items] | |||
Decrease in selling general and administrative expenses | $ 0 | $ 0.4 | |
Mission Co-Promotion Agreement [Member] | Minimum [Member] | |||
Collaborative Arrangements And Noncollaborative Arrangement Transactions [Line Items] | |||
Share of gross profits, percentage | 50.00% |
Subsequent Events - Additional
Subsequent Events - Additional Information - (Detail) - Unsecured Loan [Member] - Subsequent Event [Member] - PPP Loan [Member] - CARES Act Of 2020 [Member] - JPMorgan Chase Bank, N.A. [Member] $ in Millions | Apr. 10, 2020USD ($) |
Subsequent Event [Line Items] | |
Loans amount | $ 1.1 |
Interest rate | 0.98% |
Loan term | 2 years |
Date of early repayment of loan in full | Apr. 23, 2020 |