Document and Entity Information
Document and Entity Information - shares | 3 Months Ended | |
Mar. 31, 2020 | May 04, 2020 | |
Cover [Abstract] | ||
Entity Registrant Name | Clearside Biomedical, Inc. | |
Amendment Flag | false | |
Document Period End Date | Mar. 31, 2020 | |
Document Fiscal Year Focus | 2020 | |
Document Fiscal Period Focus | Q1 | |
Trading Symbol | CLSD | |
Document Type | 10-Q | |
Entity Central Index Key | 0001539029 | |
Current Fiscal Year End Date | --12-31 | |
Entity Filer Category | Non-accelerated Filer | |
Entity Small Business | true | |
Entity Emerging Growth Company | true | |
Entity Ex Transition Period | true | |
Entity Interactive Data Current | Yes | |
Document Transition Report | false | |
Title of 12(b) Security | Common Stock, par value $0.001 per share | |
Security Exchange Name | NASDAQ | |
Entity Incorporation, State or Country Code | DE | |
Document Quarterly Report | true | |
Entity Common Stock, Shares Outstanding | 44,868,558 | |
Entity Shell Company | false | |
Entity Current Reporting Status | Yes | |
Entity File Number | 001-37783 | |
Entity Tax Identification Number | 45-2437375 | |
Entity Address, Address Line One | 900 North Point Parkway | |
Entity Address, Address Line Two | Suite 200 | |
Entity Address, City or Town | Alpharetta | |
Entity Address, State or Province | GA | |
Entity Address, Postal Zip Code | 30005 | |
City Area Code | 678 | |
Local Phone Number | 270-3631 |
Balance Sheets
Balance Sheets - USD ($) $ in Thousands | Mar. 31, 2020 | Dec. 31, 2019 |
Current assets: | ||
Cash and cash equivalents | $ 20,930 | $ 22,595 |
Prepaid expenses | 892 | 1,139 |
Other current assets | 1,683 | 1,485 |
Total current assets | 23,505 | 25,219 |
Property and equipment, net | 551 | 541 |
Operating lease right-of-use asset | 627 | 656 |
Restricted cash | 360 | 360 |
Total assets | 25,043 | 26,776 |
Current liabilities: | ||
Accounts payable | 1,633 | 1,280 |
Accrued liabilities | 1,492 | 2,930 |
Current portion of long-term debt | 5,183 | 1,333 |
Current portion of operating lease liabilities | 363 | 360 |
Deferred revenue | 5,100 | 5,000 |
Total current liabilities | 13,771 | 10,903 |
Long-term debt | 3,819 | |
Operating lease liabilities | 832 | 897 |
Total liabilities | 14,603 | 15,619 |
Commitments and contingencies | ||
Stockholders’ equity: | ||
Preferred stock, $0.001 par value; 10,000,000 shares authorized and no shares issued at March 31, 2020 and December 31, 2019 | ||
Common stock, $0.001 par value; 100,000,000 shares authorized at March 31, 2020 and December 31, 2019; 44,868,558 and 44,413,372 shares issued and outstanding at March 31, 2020 and December 31, 2019, respectively | 45 | 44 |
Additional paid-in capital | 250,963 | 248,770 |
Accumulated deficit | (240,568) | (237,657) |
Total stockholders’ equity | 10,440 | 11,157 |
Total liabilities and stockholders’ equity | $ 25,043 | $ 26,776 |
Balance Sheets (Parenthetical)
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 |
Common stock, par value | $ 0.001 | $ 0.001 |
Common stock, shares authorized | 100,000,000 | 100,000,000 |
Common stock, shares, issued | 44,868,558 | 44,413,372 |
Common stock, shares outstanding | 44,868,558 | 44,413,372 |
Statements of Operations
Statements of Operations - USD ($) $ in Thousands | 3 Months Ended | |
Mar. 31, 2020 | Mar. 31, 2019 | |
Income Statement [Abstract] | ||
License and other revenue | $ 4,097 | $ 45 |
Type of Revenue [Extensible List] | clsd:LicenseAndOtherRevenueMember | clsd:LicenseAndOtherRevenueMember |
Operating expenses: | ||
Research and development | $ 3,811 | $ 10,967 |
General and administrative | 3,122 | 4,384 |
Total operating expenses | 6,933 | 15,351 |
Loss from operations | (2,836) | (15,306) |
Other expense | (75) | (98) |
Net loss | $ (2,911) | $ (15,404) |
Net loss per share of common stock — basic and diluted | $ (0.07) | $ (0.45) |
Weighted average shares outstanding — basic and diluted | 44,753,510 | 34,144,209 |
Statements of Stockholders' Equ
Statements of Stockholders' Equity - USD ($) $ in Thousands | Total | Common Stock | Additional Paid-in Capital | Accumulated Deficit |
Beginning balance at Dec. 31, 2018 | $ 23,620 | $ 32 | $ 230,475 | $ (206,887) |
Beginning balance, shares at Dec. 31, 2018 | 32,119,227 | |||
Issuance of common shares from follow-on public offering | 6,627 | $ 5 | 6,622 | |
Issuance of common stock for follow-on public offering, shares | 4,660,966 | |||
Exercise of stock options | 1 | 1 | ||
Exercise of stock options, shares | 2,727 | |||
Share-based compensation expense | 1,247 | 1,247 | ||
Net loss | (15,404) | (15,404) | ||
Ending balance at Mar. 31, 2019 | 16,091 | $ 37 | 238,345 | (222,291) |
Ending balance, shares at Mar. 31, 2019 | 36,782,920 | |||
Beginning balance at Dec. 31, 2019 | 11,157 | $ 44 | 248,770 | (237,657) |
Beginning balance, shares at Dec. 31, 2019 | 44,413,372 | |||
Issuance of common shares from at-the-market sales agreement | 1,193 | $ 1 | 1,192 | |
Issuance of common shares from at-the-market sales agreement, shares | 455,186 | |||
Share-based compensation expense | 1,001 | 1,001 | ||
Net loss | (2,911) | (2,911) | ||
Ending balance at Mar. 31, 2020 | $ 10,440 | $ 45 | $ 250,963 | $ (240,568) |
Ending balance, shares at Mar. 31, 2020 | 44,868,558 |
Statements of Cash Flows
Statements of Cash Flows - USD ($) $ in Thousands | 3 Months Ended | |
Mar. 31, 2020 | Mar. 31, 2019 | |
Operating activities | ||
Net loss | $ (2,911) | $ (15,404) |
Adjustments to reconcile net loss to net cash used in operating activities: | ||
Depreciation | 45 | 53 |
Share-based compensation expense | 1,001 | 1,247 |
Non-cash interest expense | 10 | 46 |
Accretion of debt discount | 21 | 15 |
Amortization and accretion on available-for-sale investments, net | (103) | |
Changes in operating assets and liabilities: | ||
Prepaid expenses and other current assets | 49 | 1,536 |
Other assets and liabilities | 68 | (29) |
Accounts payable and accrued liabilities | (1,086) | (14) |
Net cash used in operating activities | (2,803) | (12,653) |
Investing activities | ||
Maturities of available-for-sale investments | 30,950 | |
Acquisition of property and equipment | (55) | (18) |
Net cash (used in) provided by investing activities | (55) | 30,932 |
Financing activities | ||
Proceeds from at-the-market sales agreement, net of issuance costs | 1,193 | 6,627 |
Proceeds from exercise of stock options | 1 | |
Net cash provided by financing activities | 1,193 | 6,628 |
Net (decrease) increase in cash, cash equivalents and restricted cash | (1,665) | 24,907 |
Cash, cash equivalents and restricted cash, beginning of period | 22,955 | 8,403 |
Cash, cash equivalents and restricted cash, end of period | 21,290 | 33,310 |
Reconciliation of cash, cash equivalents and restricted cash | ||
Cash and cash equivalents | 20,930 | 32,950 |
Restricted cash | 360 | 360 |
Cash, cash equivalents and restricted cash, end of period | $ 21,290 | $ 33,310 |
The Company
The Company | 3 Months Ended |
Mar. 31, 2020 | |
Organization Consolidation And Presentation Of Financial Statements [Abstract] | |
The Company | 1. The Company Clearside Biomedical, Inc. (the “Company”) is a biopharmaceutical company dedicated to developing and delivering treatments that restore and preserve vision for people with serious back of the eye diseases. The Company’s proprietary SCS Microinjector targeting the suprachoroidal space offers unique access to the macula, retina and choroid where sight-threatening disease often occurs. This suprachoroidal space injection is an inherently flexible, in-office, non-surgical procedure, intended to provide targeted delivery to the site of disease and to work with both established and new formulations of medications, as well as future therapeutic innovations, such as gene therapy . Incorporated in the State of Delaware on May 26, 2011, the Company has its corporate headquarters in Alpharetta, Georgia. The Company’s activities since inception have primarily consisted of developing product and technology rights and performing research and development activities. The Company has no current source of revenue to sustain present activities, and does not expect to generate meaningful revenue until and unless the Company receives regulatory approval of and successfully commercializes its product candidates, either on its own or with a third party. The Company is subject to a number of risks and uncertainties similar to those of other life science companies at a similar stage of development, including, among others, the need to obtain adequate additional financing, successful development efforts including regulatory approval of products, compliance with government regulations, successful commercialization of potential products, protection of proprietary technology and dependence on key individuals. Liquidity The Company had cash and cash equivalents of $20.9 million as of March 31, 2020. The Company has funded its operations primarily through the sale of convertible preferred stock and common stock and the issuance of long-term debt. The Company has suffered recurring losses and negative cash flows from operations since inception and anticipates incurring additional losses until such time, if ever, that it can obtain regulatory approval to sell, and then generate significant revenue from commercializing In the absence of product or other revenues, the amount, timing, nature or source of which cannot be predicted, the Company’s losses will continue as it conducts its research and development activities. These conditions raise substantial doubt about the Company’s ability to continue as a going concern within one year after the date the financial statements are issued. Until the Company can generate sufficient revenue, the Company will need to finance future cash needs through public or private equity offerings, license agreements, debt financings or restructurings, collaborations, strategic alliances and marketing or distribution arrangements. The Company’s financial statements have been prepared on a going concern basis, which contemplates the realization of assets and satisfaction of liabilities in the normal course of business. The financial statements do not include any adjustments to reflect the possible future effects on the recoverability and classification of recorded asset amounts or the amounts and classification of liabilities that might result should the Company be unable to continue as a going concern. |
Significant Accounting Policies
Significant Accounting Policies | 3 Months Ended |
Mar. 31, 2020 | |
Accounting Policies [Abstract] | |
Significant Accounting Policies | 2. Significant Accounting Policies Basis of Presentation The Company’s financial statements have been prepared in conformity with accounting principles generally accepted in the United States of America (“U.S. GAAP”). Unaudited Interim Financial Information The accompanying balance sheet as of March 31, 2020, statements of operations for the three months ended March 31, 2020 and 2019, statements of stockholders’ equity for the three months ended March 31, 2020 and 2019 and statements of cash flows for the three months ended March 31, 2020 and 2019 are unaudited. The unaudited interim financial statements have been prepared on the same basis as the annual financial statements and, in the opinion of management, reflect all adjustments, which include normal recurring adjustments, necessary for the fair presentation of the Company’s financial position as of March 31, 2020, its results of its operations for the three months ended March 31, 2020 and 2019, its changes in stockholders’ equity for the three months ended March 31, 2020 and 2019 and its cash flows for the three months ended March 31, 2020 and 2019. The financial data and other information disclosed in these notes related to the three months ended March 31, 2020 and 2019 are unaudited. The results for the three months ended March 31, 2020 are not indicative of results to be expected for the year ending December 31, 2020, any other interim periods or any future year or period. These unaudited financial statements should be read in conjunction with the audited financial statements and related footnotes, which are included in the Company’s Annual Report on Form 10-K for the year ended December 31, 2019. Use of Estimates The preparation of financial statements in conformity with U.S. 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 reported amounts of income and expenses during the reporting periods. Significant items subject to such estimates and assumptions include the accounting for useful lives to calculate depreciation and amortization, clinical expense accruals, share-based compensation expense and income tax valuation allowance. Actual results could differ from these estimates. The COVID-19 pandemic is expected to result in a global slowdown of economic activity. Estimates and assumptions about future events and their effects cannot be determined with certainty and therefore require the exercise of judgment. As of the date of issuance of these financial statements, we are not aware of any specific event or circumstance that would require us to update our estimates, assumptions and judgments or revise the carrying value of our assets or liabilities. These estimates may change as new events occur and additional information is obtained and are recognized in the consolidated financial statements as soon as they become known. Actual results could differ from those estimates and any such differences may be material to our financial statements. Revenue Recognition The Company recognizes revenue from its contracts with customers under Financial Accounting Standards Board (“FASB”) Accounting Standards Codification (“ASC”) Topic 606, Revenue from Contracts with Customers The Company receives payments from its customers based on billing schedules established in each contract. Upfront and other payments may require deferral of revenue recognition to a future period until the Company performs its obligations under the arrangement. Amounts are recorded as accounts receivable when the Company’s right to consideration is unconditional. The Company does not assess whether a contract has a significant financing component if the expectation at contract inception is such that the period between payment by the customer and the transfer of the promised goods or services to the customer will be one year or less. Research and Development Costs Research and development costs are charged to expense as incurred and include: • employee-related expenses, including salaries, benefits, travel and share-based compensation expense for research and development personnel; • expenses incurred under agreements with contract research organizations, contract manufacturing organizations and consultants that conduct clinical trials and preclinical studies; • costs associated with preclinical and clinical development activities; • costs associated with submitting regulatory approval applications for the Company’s product candidates; • costs associated with training physicians on the suprachoroidal injection procedure and educating and providing them with appropriate product candidate information; • costs associated with technology and intellectual property licenses; • costs for the Company’s research and development facility; and • depreciation expense for assets used in research and development activities. Costs for certain development activities, such as clinical trials, are recognized based on an evaluation of the progress to completion of specific tasks using data such as patient enrollment, clinical site activations, or information provided to the Company by its vendors on their actual costs incurred. Payments for these activities are based on the terms of the individual arrangements, which may differ from the patterns of costs incurred, and are reflected in the financial statements as prepaid or accrued expense. Share-Based Compensation Compensation cost related to share-based awards granted to employees is measured based on the estimated fair value of the award at the grant date. The Company estimates the fair value of stock options using a Black-Scholes option pricing model. Compensation expense for options granted to non-employees is determined as the fair value of consideration received or the fair value of the equity instruments issued, whichever is more reliably measured. The fair value of restricted stock units granted is measured based on the market value of the Company’s common stock on the date of grant. Share-based compensation costs are expensed on a straight-line basis over the relevant vesting period. Compensation cost related to shares purchased through the Company’s employee stock purchase plan, which is considered compensatory, is based on the estimated fair value of the shares on the offering date, including consideration of the discount and the look back period. The Company estimates the fair value of the shares using a Black-Scholes option pricing model. Compensation expense is recognized over the six-month withholding period prior to the purchase date. All share-based compensation costs are recorded in general and administrative or research and development costs in the statements of operations based upon the underlying employees’ roles within the Company. Cash Equivalents Cash equivalents consist of short-term, highly liquid investments with an original term of three months or less at the date of purchase. Concentration of Credit Risk Arising From Cash Deposits in Excess of Insured Limits The Company maintains its cash in bank deposits that at times may exceed federally insured limits. The Company has not experienced any loss in such accounts. The Company believes it is not exposed to any significant risks with respect to its cash balances. Recent Accounting Pronouncements Accounting Pronouncements Recently Adopted In August 2018, the FASB issued ASU 2018-13, Fair Value Measurement (Topic 820-10): Disclosure Framework-Changes to the Disclosure Requirements for Fair Value Measurement Fair Value Measurements and Disclosures In June 2016, the FASB issued ASU 2016-13, Financial Instruments-Credit Losses (Topic 326): Measurement of Credit Losses on Financial Instruments , which requires the measurement and recognition of expected credit losses for financial assets held at amortized cost, including trade receivables. ASU 2016-13 replaces the existing incurred loss impairment model with an expected loss model that requires the use of forward-looking information to calculate credit loss estimates. The Company adopted ASU 2016-13 on January 1, 2020, and the adoption did not have a material impact on its financial statements and related disclosures. Recent Accounting Pronouncements Not Yet Adopted In December 2019, the FASB issued ASU 2019-12, Income Taxes (Topic 740): Simplifying the Accounting for Income Taxes |
Property and Equipment, Net
Property and Equipment, Net | 3 Months Ended |
Mar. 31, 2020 | |
Property Plant And Equipment [Abstract] | |
Property and Equipment, Net | 3. Property and Equipment, Net Property and equipment, net consisted of the following (dollar amounts in thousands): Estimated Useful Lives (Years) March 31, 2020 December 2019 Furniture and fixtures 5 $ 337 $ 337 Machinery and equipment 5 176 121 Computer equipment 3 13 13 Leasehold improvements Lesser of useful life remaining lease term 667 667 1,193 1,138 Less: Accumulated depreciation (642 ) (597 ) $ 551 $ 541 |
Accrued Liabilities
Accrued Liabilities | 3 Months Ended |
Mar. 31, 2020 | |
Payables And Accruals [Abstract] | |
Accrued Liabilities | 4. Accrued Liabilities Accrued liabilities consisted of the following (in thousands): March 31, December 2020 2019 Accrued research and development $ 185 $ 359 Accrued employee costs 425 1,530 Accrued severance 531 751 Accrued professional fees 122 58 Accrued expense 229 232 $ 1,492 $ 2,930 |
Long-Term Debt
Long-Term Debt | 3 Months Ended |
Mar. 31, 2020 | |
Debt Disclosure [Abstract] | |
Long-Term Debt | 5. Long-Term Debt Loan and Security Agreements On May 14, 2018, the Company entered into a second amended and restated loan and security agreement (the “2 nd nd nd The Company borrowed an initial tranche of $10.0 million on May 14, 2018, of which $7.0 million was used to repay all amounts outstanding under the first amended and restated loan agreement, including fees associated with the final payment. The prepayment fees were waived. Of the remaining $10.0 million under the 2 nd On October 18, 2019, the Company entered into an amendment to the 2 nd 2 In addition, the Company agreed that if the Company’s cash and cash equivalents balance with SVB falls below $10.0 million, the Company will transfer to a pledged account an amount of cash and cash equivalents equal to the sum of the then-outstanding principal balance of the term loan plus a final payment fee of $0.3 million. On May 7, 2020, the Company paid $5.0 million principal balance under the 2 nd The borrowings under the 2 nd Interest expense on the borrowings under the loan agreements described above was $106,000 and $225,000 for the three months ended March 31, 2020 and 2019, respectively. Accretion of the scheduled final payment was $10,000 and $46,000 for the three months ended March 31, 2020 and 2019, respectively. Accretion of the deferred debt issuance costs was $21,000 and $15,000 for the three months ended March 31, 2020 and 2019, respectively. As of March 31, 2020, the scheduled payments for the 2nd A&R Loan Agreement, as amended, and the scheduled final payment were as follows (in thousands): Year Ending December 31, Principal Interest and Final Total 2020 $ 5,000 $ 382 $ 5,382 |
Common Stock
Common Stock | 3 Months Ended |
Mar. 31, 2020 | |
Equity [Abstract] | |
Common Stock | 6. Common Stock The Company’s amended and restated certificate of incorporation authorizes the Company to issue 100,000,000 shares of $0.001 par value common stock. As of March 31, 2020 and December 31, 2019, there were 44,868,558 and 44,413,372 shares of common stock outstanding, respectively. |
Stock Purchase Warrants
Stock Purchase Warrants | 3 Months Ended |
Mar. 31, 2020 | |
Stock Purchase Warrants [Abstract] | |
Stock Purchase Warrants | 7. Stock Purchase Warrants In September 2016, in connection with a loan agreement, the Company issued warrants to purchase up to 29,796 shares of common stock at a price per share of $10.74. The warrants expire in September 2026, or earlier upon the occurrence of specified mergers or acquisitions of the Company, and are immediately exercisable . |
Share-Based Compensation
Share-Based Compensation | 3 Months Ended |
Mar. 31, 2020 | |
Disclosure Of Compensation Related Costs Sharebased Payments [Abstract] | |
Share-Based Compensation | 8. Share-Based Compensation Share-based compensation is accounted for in accordance with the provisions of ASC 718, Compensation-Stock Compensation Stock Options The Company has granted stock option awards to employees, directors and consultants from its 2011 Stock Incentive Plan (the “2011 Plan”) and its 2016 Equity Incentive Plan (the “2016 Plan”). The estimated fair value of options granted is determined as of the date of grant using the Black-Scholes option pricing model. The resulting fair value is recognized ratably over the requisite service period, which is generally the vesting period of the awards. Share-based compensation expense for options granted under the 2011 Plan and the 2016 Plan is reflected in the statements of operations as follows (in thousands): Three Months Ended March 31, 2020 2019 Research and development $ 306 $ 462 General and administrative 413 775 Total $ 719 $ 1,237 The following table summarizes the activity related to stock options during the three months ended March 31, 2020: Weighted Number of Average Shares Exercise Price Options outstanding at December 31, 2019 4,104,450 $ 4.63 Granted 903,500 2.37 Forfeited (9,845 ) 3.05 Options outstanding at March 31, 2020 4,998,105 4.23 Options exercisable at December 31, 2019 2,452,764 5.44 Options exercisable at March 31, 2020 2,782,163 5.14 As of March 31, 2020, the Company had $5.1 million of unrecognized compensation expense related to unvested stock options, which is expected to be recognized over a weighted average period of 2.6 years. Restricted Stock Units The Company has granted restricted stock units (“RSUs”) to employees from the 2016 Plan. The shares underlying the RSU awards have vesting terms of eight months to four years from the date of grant subject to the employees’ continuous service and subject to accelerated vesting in specified circumstances. The fair value of the RSUs granted is measured based on the market value of the Company’s common stock on the date of grant and is recognized ratably over the requisite service period, which is generally the vesting period of the awards. The following table summarizes the activity related to RSUs during the three months ended March 31, 2020: Weighted Average Number of Grant Date Shares Fair Value Non-vested RSUs outstanding at December 31, 2019 1,269,300 $ 0.87 Granted 486,000 2.39 Vested (100,000 ) 1.02 Forfeited (6,700 ) 0.91 Non-vested RSUs outstanding at March 31, 2020 1,648,600 1.31 The Company recorded $0.3 million of share-based compensation expense for the three months ended March 31, 2020 for the RSUs. There were no RSUs issued during the same period in the prior year. As of March 31, 2020, the Company had $1.6 million of unrecognized compensation expense related to the RSUs, which is expected to be recognized over a weighted average period of 2.9 years. Employee Stock Purchase Plan In January 2016, the Company’s board of directors adopted and approved, and in January 2016 the Company’s stockholders approved, the Clearside Biomedical, Inc. 2016 Employee Stock Purchase Plan (the “2016 ESPP”) which became effective on June 1, 2016. The 2016 ESPP is considered a compensatory plan and the fair value of the discount and the look-back period are estimated using the Black-Scholes option pricing model and expense is recognized over the six month withholding period prior to the purchase date. The Company has recorded $3,000 and $10,000 of share-based compensation expense for the three months ended March 31, 2020 and 2019, respectively, in the statements of operations for the estimated number of shares to be purchased on the next purchase date following the conclusion of the applicable reporting period. |
Commitment and Contingencies
Commitment and Contingencies | 3 Months Ended |
Mar. 31, 2020 | |
Commitments And Contingencies Disclosure [Abstract] | |
Commitments and Contingencies | 9. Commitments and Contingencies Lease Commitment Summary In November 2016, the Company signed an office lease agreement to lease approximately 20,000 square feet of office space in Alpharetta, Georgia for its corporate headquarters. The lease agreement is for a 6.5 year term with a renewal option for one additional five-year term. Rental payments are $35,145 per month subject to an increase of 3% per year. Rent expense under this lease is recognized on a straight-line basis over the term of the lease. In addition, the lease agreement requires payment of the pro-rata share of the annual operating expenses associated with the premises. The Company’s operating leases included on the balance sheet are as follows (in thousands): March 31, 2020 Operating lease right-of-use asset $ 627 Liabilities Current portion of operating lease liabilities $ 363 Operating lease liabilities 832 Total operating lease liabilities $ 1,195 The Company recognizes a right-of-use asset for the right to use the underlying asset for the lease term, and a lease liability, which represents the present value of the Company’s obligation to make payments over the lease term. The renewal option is not included in the calculation of the right-of-use asset and the lease liabilities as the Company has not yet determined if the Alpharetta, Georgia lease will be renewed. The present value of the lease payments is calculated using an incremental borrowing rate as the Company’s leases do not provide an implicit interest rate. At March 31, 2020, the Company’s weighted average discount rate was 11.0% and the weighted average lease term was 3.5 years. Minimum lease payments were as follows at March 31, 2020 (in thousands): Year Ending December 31, 2020 286 2021 392 2022 407 2023 316 Total minimum lease payments 1,401 Less imputed interest (206 ) Total operating lease liabilities $ 1,195 Equipment leases with an initial term of 12 months or less are not recorded with operating lease liabilities. The Company recognizes expense for these on a straight-line basis over the lease term. The equipment leases were deemed to be immaterial. Operating lease cost was $62,000 and $100,000 for the three months ended March 31, 2020 and 2019, respectively. Variable lease cost was $24,000 and $30,000 for the three months ended March 31, 2020 and 2019, respectively. Short-term lease cost for the three months ended March 31, 2020 and 2019 was $4,000 and $3,000, respectively. Cash payments included in operating activities on the statement of cash flows for operating lease liabilities were $92,000 and $129,000 for the three months ended March 31, 2020 and 2019, respectively. Contract Service Providers In the course of the Company’s normal business operations, it has agreements with contract service providers to assist in the performance of its research and development, clinical research and manufacturing. Substantially all of these contracts are on an as needed basis. |
License and Other Agreements
License and Other Agreements | 3 Months Ended |
Mar. 31, 2020 | |
License And Other Agreement [Abstract] | |
License and Other Agreements | 10. License and Other Agreements Arctic Vision (Hong Kong) Limited On March 10, 2020, the Company entered into a License Agreement (the “Arctic License Agreement”) with Arctic Vision (Hong Kong) Limited (“Arctic Vision”). Pursuant to the Arctic License Agreement, the Company has granted an exclusive license to Arctic Vision to develop, distribute, promote, market and commercialize XIPERE, the Company’s proprietary suspension of the corticosteroid triamcinolone acetonide formulated for administration to the back of the eye using the Company’s proprietary SCS Microinjector, subject to specified exceptions, in China, Hong Kong, Macau, Taiwan and South Korea (the “Arctic Territory”). Under the terms of the Arctic License Agreement, neither party may commercialize XIPERE in the other party’s territory. Arctic Vision has agreed to use commercially reasonably efforts to pursue development and commercialization of XIPERE for indications associated with uveitis in the Arctic Territory. In addition, upon receipt of the Company’s consent, Arctic Vision will have the right, but not the obligation, to develop and commercialize XIPERE for additional indications in the Arctic Territory. Pursuant to the Arctic License Agreement, Arctic Vision has agreed to pay the Company up to a total of $35.5 million. This amount includes an upfront payment of $4.0 million as well as an aggregate of up to $31.5 million in development milestone payments for specified events prior to and including receipt of approval of XIPERE in the United States and sales milestone payments for achievement of specified levels of net sales. Further, during the applicable royalty term, the Company will also be entitled to receive tiered royalties of ten to twelve percent of net sales based on achieving certain annual net sales thresholds in the Arctic Territory, subject to customary reductions, payable on a product-by-product and country-by-country basis, commencing at launch in such country and lasting until the latest of (i) the date that all valid claims within the licensed patent rights covering XIPERE have expired, (ii) the date of the loss of marketing or regulatory exclusivity of XIPERE in a given country, or (iii) ten years from the first commercial sale of XIPERE in a given country. As of March 31, 2020, it was determined that the Company had completed its performance obligations related to the upfront payment and recognized license revenue of $4.0 million. Other The Company has periodically entered into other short-term agreements, generally with performance obligations of one to two months, to evaluate the potential use of its proprietary SCS Microinjector with third-party product candidates for the treatment of various diseases. Funds received from these agreements are recognized as revenue over the term of the agreement. The Company recorded $45,000 of revenue from these agreements during the three months ended March 31, 2019. In addition, the Company recorded $0.1 million of deferred revenue in other current liabilities from these agreements as of March 31, 2020. |
Fair Value Measurements
Fair Value Measurements | 3 Months Ended |
Mar. 31, 2020 | |
Fair Value Disclosures [Abstract] | |
Fair Value Measurements | 11. Fair Value Measurements The Company records certain financial assets and liabilities at fair value in accordance with the provisions of ASC Topic 820, Fair Value Measurements and Disclosures • Level 1—Unadjusted quoted prices in active, accessible markets for identical assets or liabilities. • Level 2—Other inputs that are directly or indirectly observable in the marketplace. • Level 3—Unobservable inputs that are supported by little or no market activity. The fair value hierarchy also requires an entity to maximize the use of observable inputs and minimize the use of unobservable inputs when measuring fair value. The Company’s material financial instruments at March 31, 2020 and December 31, 2019 consisted primarily of cash and cash equivalents and long-term debt. The fair values of cash and cash equivalents, other current assets and accounts payable approximate their respective carrying values due to the short term nature of these instruments and are classified as Level 1 in the fair value hierarchy. The fair value of long-term debt approximates the carrying value due to variable interest rates that correspond to market rates and is classified as Level 1 in the fair value hierarchy. There were no significant transfers between Levels 1, 2 and 3 during the three months ended March 31, 2020 and the year ended December 31, 2019. The following tables summarize the fair value of financial assets that are measured at fair value and the classification by level of input within the fair value hierarchy (in thousands): March 31, 2020 Level 1 Level 2 Level 3 Recorded Value Financial Assets: Cash and money markets $ 20,930 $ — $ — $ 20,930 Restricted cash money market 360 — — 360 Total financial assets $ 21,290 $ — $ — $ 21,290 December 31, 2019 Level 1 Level 2 Level 3 Recorded Value Financial Assets: Cash and money markets $ 22,595 $ — $ — $ 22,595 Restricted cash money market 360 — — 360 Total financial assets $ 22,955 $ — $ — $ 22,955 |
Net Loss per Share
Net Loss per Share | 3 Months Ended |
Mar. 31, 2020 | |
Earnings Per Share [Abstract] | |
Net Loss Per Share | 12. Net Loss Per Share Basic net loss per share is calculated by dividing the net loss by the weighted average number of shares of common stock outstanding for the period, without consideration of the dilutive effect of potential common stock equivalents. Diluted net loss per share gives effect to all dilutive potential shares of common stock outstanding during this period. For all periods presented, the Company’s potential common stock equivalents, which included stock options and stock purchase warrants, have been excluded from the computation of diluted net loss per share as their inclusion would have the effect of reducing the net loss per share. Therefore, the denominator used to calculate both basic and diluted net loss per share is the same in all periods presented. The Company’s potential common stock equivalents that have been excluded from the computation of diluted net loss per share for all periods presented because of their antidilutive effect consisted of the following: Three Months Ended March 31, 2020 2019 Outstanding stock options 4,998,105 4,832,889 Non-vested restricted stock units 1,648,600 — Stock purchase warrants 29,796 29,796 6,676,501 4,862,685 |
Subsequent Events
Subsequent Events | 3 Months Ended |
Mar. 31, 2020 | |
Subsequent Events [Abstract] | |
Subsequent Events | 13. Subsequent Events License Agreement Amendment On April 27, 2020, the Company and Bausch Health Ireland Limited (“Bausch”) entered into an amendment (the “Amendment”) to the Company’s License Agreement with Bausch dated October 22, 2019 (as amended, the “Bausch License Agreement”). Pursuant to the Bausch License Agreement, the Company has granted an exclusive license to Bausch to develop, manufacture, distribute, promote, market and commercialize XIPERE, the Company’s proprietary suspension of the corticosteroid triamcinolone acetonide formulated for administration to the back of the eye using the Company’s proprietary microneedle (the “Device”), as well as specified other steroids, corticosteroids and NSAIDs in combination with the Device (“Other Products”; and together with XIPERE, “Products”), subject to specified exceptions, in the United States and Canada (the “Original Territory”) for the treatment of ophthalmology indications, including non-infectious uveitis. Pursuant to the Amendment, the Company has granted Bausch an exclusive option to develop, manufacture, distribute, promote, market and commercialize XIPERE in one or more of the following regions (the “Option”): (i) the European Union, including the United Kingdom, (ii) Australia and New Zealand and (iii) South America and Mexico (such regions, the “Additional Regions” and together with the Original Territory, the “Territory”). The Option may be exercised any time before the earlier of regulatory approval of XIPERE in the United States and August 31, 2021. Pursuant to the Bausch License Agreement, Bausch paid the Company an upfront payment of $5.0 million (the “Upfront Payment”) in October 2019, which is subject to a refund if the Bausch License Agreement is terminated in specified circumstances. In addition, Bausch has agreed to make additional payments of up to $15.0 million upon the achievement of specified pre-launch development and regulatory milestones (the “Pre-Launch Milestone Payments”) and up to an aggregate of $57.3 million in additional milestone payments upon the achievement of (i) specified regulatory approvals for specified additional indications of XIPERE (including certain regulatory and commercial milestones if Bausch exercises its Option in the European Union) and (ii) specified levels of annual net sales (as defined in the Bausch License Agreement). Further, during the applicable royalty term, the Company will also be entitled to receive tiered royalties at increasing percentages, from the high-teens to twenty percent, based on XIPERE achieving certain annual net sales thresholds in the Original Territory, as well as a lower royalty on annual net sales of Other Products in the Original Territory and on annual net sales of Xipere The Company is responsible for all development expenses for XIPERE in the Original Territory until the Company’s New Drug Application (“NDA”) for XIPERE NDA During the term of the Bausch License Agreement, and in the Territory, the Company has agreed not to (i) develop or commercialize XIPERE alone or in combination with an Other Device (as defined in the Bausch License Agreement) in the licensed field, (ii) develop or commercialize any corticosteroid with the Device or an Other Device in the licensed field, (iii) develop or commercialize the Device or an Other Device with any active pharmaceutical ingredient for non-infectious uveitis or macular edema associated with non-infectious uveitis, including with any Other Drug (as defined in the Bausch License Agreement, which are restricted to those steroids, corticosteroids and non-steroidal anti-inflammatory drugs specifically identified in the Bausch License Agreement), (iv) develop or commercialize any Other Drug in combination with the Device and (v) commercialize any Other Device for achieving non-surgical access to the suprachoroidal space where such device is sold as a stand-alone product, subject to specified exceptions. The Bausch License Agreement will expire upon expiration of the royalty terms for all Products and countries in the Territory, with each royalty term for a given Product and country ending on the latest of (i) the date of expiration of the last-to-expire valid claim of any licensed patent rights covering such Product in such country in the Territory, (ii) the date of the loss of regulatory exclusivity for such Product in such country in the Territory, or (iii) ten years from the later of the first sale of such Product in such country in the Territory. For a specified period of time, Bausch may terminate the Bausch License Agreement immediately and have the Upfront Payment refunded if the FDA has not approved the XIPERE NDA by August 31, 2021. Following the payment of the Pre-Launch Milestone Payments, Bausch may also terminate the Bausch License Agreement for convenience upon 180 days’ written notice. In addition, the Company can terminate the Bausch License Agreement if Bausch commences a legal action challenging the validity, enforceability or scope of any of the licensed patents. If the FDA requires an additional clinical trial prior to approving the NDA for XIPERE and the Company notifies Bausch that the Company will not conduct the trial at the Company’s expense, then Bausch may terminate the Bausch License Agreement and have the Upfront Payment refunded within 60 days of the receipt of such notice from the Company. Both parties may terminate the Bausch License Agreement (i) upon a material breach of the Bausch License Agreement, subject to a specified cure period and specified exceptions, or (ii) if the other party encounters bankruptcy or insolvency. Upon termination (other than for a material breach by or bankruptcy or insolvency event of the Company), all licenses and other rights granted by the Company to Bausch pursuant to the Bausch License Agreement would revert to the Company. CARES Act Paycheck Protection Program (PPP) Loan On April 20, 2020, the Company entered into a loan agreement with Silicon Valley Bank (“PPP Lender”) under the terms of which the PPP Lender agreed to make a loan to the Company in an aggregate principal amount of $1.0 million (“PPP Loan”) pursuant to the Paycheck Protection Program under the Coronavirus Aid, Relief, and Economic Security Act (the “CARES Act”). The PPP Loan is evidenced by a promissory note (the “Note”) containing the terms and conditions for repayment of the PPP Loan. Under the terms of the Note and the PPP Loan, interest accrues on the outstanding principal at the rate of 1.0% per annum. The term of the Note is two years, though it may be payable sooner in connection with an event of default under the Note. To the extent the loan amount is not forgiven under the PPP, the Company is obligated to make equal monthly payments of principal and interest, beginning seven months from the date of the Note, until the maturity date. The CARES Act and the PPP provide a mechanism for forgiveness of up to the full amount borrowed. Under the PPP, the Company may apply for forgiveness for all or a part of the PPP Loan. The amount of loan proceeds eligible for forgiveness is based on a formula that takes into account a number of factors, including the amount of loan proceeds used by the Company during the eight-week period after the loan origination for certain purposes including payroll costs, interest on certain mortgage obligations, rent payments on certain leases, and certain qualified utility payments, provided that at least 75% of the loan amount is used for eligible payroll costs; the employer maintaining or rehiring employees and maintaining salaries at certain levels; and other factors. Subject to the other requirements and limitations on loan forgiveness, only loan proceeds spent on payroll and other eligible costs during the covered eight-week period will qualify for forgiveness. The Company intends to use the entire Loan amount for qualifying expenses, though no assurance is provided that the Company will obtain forgiveness of the PPP Loan in whole or in part. The Note may be prepaid in part or in full, at any time, without penalty. The Note provides for certain customary events of default, including (i) failing to make a payment when due under the Note, (ii) failure to do anything required by the Note or any other loan document, (iii) defaults of any other loan with the PPP Lender, (iv) failure to disclose any material fact or make a materially false or misleading representation to the PPP Lender or SBA, (v) default on any loan or agreement with another creditor, if the PPP Lender believes the default may materially affect the Company’s ability to pay the Note, (vi) failure to pay any taxes when due, (vii) becoming the subject of a proceeding under any bankruptcy or insolvency law, having a receiver or liquidator appointed for any part of the Company’s business or property, or making an assignment for the benefit of creditors, (viii) having any adverse change in financial condition or business operation that the PPP Lender believes may materially affect the Company’s ability to pay the Note, (ix) if the Company reorganizes, merges, consolidates, or otherwise changes ownership or business structure without the PPP Lender’s prior written consent, or (x) becoming the subject of a civil or criminal action that the PPP Lender believes may materially affect the Company’s ability to pay the Note. Upon the occurrence of an event of default, the PPP Lender has customary remedies and may, among other things, require immediate payment of all amounts owed under the Note, collect all amounts owing from the Company, and file suit and obtain judgment against the Company. Loan Payment On May 7, 2020, due to various restrictions and other limiting covenants of the 2 nd the Company $5.0 million principal balance, plus $0.3 million reflecting the final payment fee and accrued interest. he Company intends to pursue a new debt facility to replace some or all of the repaid loan in order to meet future financial needs. |
Significant Accounting Polici_2
Significant Accounting Policies (Policies) | 3 Months Ended |
Mar. 31, 2020 | |
Accounting Policies [Abstract] | |
Basis of Presentation | Basis of Presentation The Company’s financial statements have been prepared in conformity with accounting principles generally accepted in the United States of America (“U.S. GAAP”). |
Unaudited Interim Financial Information | Unaudited Interim Financial Information The accompanying balance sheet as of March 31, 2020, statements of operations for the three months ended March 31, 2020 and 2019, statements of stockholders’ equity for the three months ended March 31, 2020 and 2019 and statements of cash flows for the three months ended March 31, 2020 and 2019 are unaudited. The unaudited interim financial statements have been prepared on the same basis as the annual financial statements and, in the opinion of management, reflect all adjustments, which include normal recurring adjustments, necessary for the fair presentation of the Company’s financial position as of March 31, 2020, its results of its operations for the three months ended March 31, 2020 and 2019, its changes in stockholders’ equity for the three months ended March 31, 2020 and 2019 and its cash flows for the three months ended March 31, 2020 and 2019. The financial data and other information disclosed in these notes related to the three months ended March 31, 2020 and 2019 are unaudited. The results for the three months ended March 31, 2020 are not indicative of results to be expected for the year ending December 31, 2020, any other interim periods or any future year or period. These unaudited financial statements should be read in conjunction with the audited financial statements and related footnotes, which are included in the Company’s Annual Report on Form 10-K for the year ended December 31, 2019. |
Use of Estimates | Use of Estimates The preparation of financial statements in conformity with U.S. 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 reported amounts of income and expenses during the reporting periods. Significant items subject to such estimates and assumptions include the accounting for useful lives to calculate depreciation and amortization, clinical expense accruals, share-based compensation expense and income tax valuation allowance. Actual results could differ from these estimates. The COVID-19 pandemic is expected to result in a global slowdown of economic activity. Estimates and assumptions about future events and their effects cannot be determined with certainty and therefore require the exercise of judgment. As of the date of issuance of these financial statements, we are not aware of any specific event or circumstance that would require us to update our estimates, assumptions and judgments or revise the carrying value of our assets or liabilities. These estimates may change as new events occur and additional information is obtained and are recognized in the consolidated financial statements as soon as they become known. Actual results could differ from those estimates and any such differences may be material to our financial statements. |
Revenue Recognition | Revenue Recognition The Company recognizes revenue from its contracts with customers under Financial Accounting Standards Board (“FASB”) Accounting Standards Codification (“ASC”) Topic 606, Revenue from Contracts with Customers The Company receives payments from its customers based on billing schedules established in each contract. Upfront and other payments may require deferral of revenue recognition to a future period until the Company performs its obligations under the arrangement. Amounts are recorded as accounts receivable when the Company’s right to consideration is unconditional. The Company does not assess whether a contract has a significant financing component if the expectation at contract inception is such that the period between payment by the customer and the transfer of the promised goods or services to the customer will be one year or less. |
Research and Development Costs | Research and Development Costs Research and development costs are charged to expense as incurred and include: • employee-related expenses, including salaries, benefits, travel and share-based compensation expense for research and development personnel; • expenses incurred under agreements with contract research organizations, contract manufacturing organizations and consultants that conduct clinical trials and preclinical studies; • costs associated with preclinical and clinical development activities; • costs associated with submitting regulatory approval applications for the Company’s product candidates; • costs associated with training physicians on the suprachoroidal injection procedure and educating and providing them with appropriate product candidate information; • costs associated with technology and intellectual property licenses; • costs for the Company’s research and development facility; and • depreciation expense for assets used in research and development activities. Costs for certain development activities, such as clinical trials, are recognized based on an evaluation of the progress to completion of specific tasks using data such as patient enrollment, clinical site activations, or information provided to the Company by its vendors on their actual costs incurred. Payments for these activities are based on the terms of the individual arrangements, which may differ from the patterns of costs incurred, and are reflected in the financial statements as prepaid or accrued expense. |
Share-Based Compensation | Share-Based Compensation Compensation cost related to share-based awards granted to employees is measured based on the estimated fair value of the award at the grant date. The Company estimates the fair value of stock options using a Black-Scholes option pricing model. Compensation expense for options granted to non-employees is determined as the fair value of consideration received or the fair value of the equity instruments issued, whichever is more reliably measured. The fair value of restricted stock units granted is measured based on the market value of the Company’s common stock on the date of grant. Share-based compensation costs are expensed on a straight-line basis over the relevant vesting period. Compensation cost related to shares purchased through the Company’s employee stock purchase plan, which is considered compensatory, is based on the estimated fair value of the shares on the offering date, including consideration of the discount and the look back period. The Company estimates the fair value of the shares using a Black-Scholes option pricing model. Compensation expense is recognized over the six-month withholding period prior to the purchase date. All share-based compensation costs are recorded in general and administrative or research and development costs in the statements of operations based upon the underlying employees’ roles within the Company. |
Cash Equivalents | Cash Equivalents Cash equivalents consist of short-term, highly liquid investments with an original term of three months or less at the date of purchase. |
Concentration of Credit Risk Arising From Cash Deposits in Excess of Insured Limits | Concentration of Credit Risk Arising From Cash Deposits in Excess of Insured Limits The Company maintains its cash in bank deposits that at times may exceed federally insured limits. The Company has not experienced any loss in such accounts. The Company believes it is not exposed to any significant risks with respect to its cash balances. |
Recent Accounting Pronouncements | Recent Accounting Pronouncements Accounting Pronouncements Recently Adopted In August 2018, the FASB issued ASU 2018-13, Fair Value Measurement (Topic 820-10): Disclosure Framework-Changes to the Disclosure Requirements for Fair Value Measurement Fair Value Measurements and Disclosures In June 2016, the FASB issued ASU 2016-13, Financial Instruments-Credit Losses (Topic 326): Measurement of Credit Losses on Financial Instruments , which requires the measurement and recognition of expected credit losses for financial assets held at amortized cost, including trade receivables. ASU 2016-13 replaces the existing incurred loss impairment model with an expected loss model that requires the use of forward-looking information to calculate credit loss estimates. The Company adopted ASU 2016-13 on January 1, 2020, and the adoption did not have a material impact on its financial statements and related disclosures. Recent Accounting Pronouncements Not Yet Adopted In December 2019, the FASB issued ASU 2019-12, Income Taxes (Topic 740): Simplifying the Accounting for Income Taxes |
Property and Equipment, Net (Ta
Property and Equipment, Net (Tables) | 3 Months Ended |
Mar. 31, 2020 | |
Property Plant And Equipment [Abstract] | |
Schedule of Property and Equipment, Net | Property and equipment, net consisted of the following (dollar amounts in thousands): Estimated Useful Lives (Years) March 31, 2020 December 2019 Furniture and fixtures 5 $ 337 $ 337 Machinery and equipment 5 176 121 Computer equipment 3 13 13 Leasehold improvements Lesser of useful life remaining lease term 667 667 1,193 1,138 Less: Accumulated depreciation (642 ) (597 ) $ 551 $ 541 |
Accrued Liabilities (Tables)
Accrued Liabilities (Tables) | 3 Months Ended |
Mar. 31, 2020 | |
Payables And Accruals [Abstract] | |
Schedule of Accrued Liabilities | Accrued liabilities consisted of the following (in thousands): March 31, December 2020 2019 Accrued research and development $ 185 $ 359 Accrued employee costs 425 1,530 Accrued severance 531 751 Accrued professional fees 122 58 Accrued expense 229 232 $ 1,492 $ 2,930 |
Long-Term Debt (Tables)
Long-Term Debt (Tables) | 3 Months Ended |
Mar. 31, 2020 | |
Second Amended and Restated Loan and Security Agreement | |
Scheduled Payments for the Second Amended and Restated Loan and Security Agreement | As of March 31, 2020, the scheduled payments for the 2nd A&R Loan Agreement, as amended, and the scheduled final payment were as follows (in thousands): Year Ending December 31, Principal Interest and Final Total 2020 $ 5,000 $ 382 $ 5,382 |
Share-Based Compensation (Table
Share-Based Compensation (Tables) | 3 Months Ended |
Mar. 31, 2020 | |
Summary of Share-based Compensation Expense | Share-based compensation expense for options granted under the 2011 Plan and the 2016 Plan is reflected in the statements of operations as follows (in thousands): Three Months Ended March 31, 2020 2019 Research and development $ 306 $ 462 General and administrative 413 775 Total $ 719 $ 1,237 |
Summary of Activity Related to Stock Options | The following table summarizes the activity related to stock options during the three months ended March 31, 2020: Weighted Number of Average Shares Exercise Price Options outstanding at December 31, 2019 4,104,450 $ 4.63 Granted 903,500 2.37 Forfeited (9,845 ) 3.05 Options outstanding at March 31, 2020 4,998,105 4.23 Options exercisable at December 31, 2019 2,452,764 5.44 Options exercisable at March 31, 2020 2,782,163 5.14 |
Restricted Stock Units (RSUs) | |
Summary of the Activity Related to RSUs | The following table summarizes the activity related to RSUs during the three months ended March 31, 2020: Weighted Average Number of Grant Date Shares Fair Value Non-vested RSUs outstanding at December 31, 2019 1,269,300 $ 0.87 Granted 486,000 2.39 Vested (100,000 ) 1.02 Forfeited (6,700 ) 0.91 Non-vested RSUs outstanding at March 31, 2020 1,648,600 1.31 |
Commitment and Contingencies (T
Commitment and Contingencies (Tables) | 3 Months Ended |
Mar. 31, 2020 | |
Commitments And Contingencies Disclosure [Abstract] | |
Operating Leases Included on the Balance Sheet | The Company’s operating leases included on the balance sheet are as follows (in thousands): March 31, 2020 Operating lease right-of-use asset $ 627 Liabilities Current portion of operating lease liabilities $ 363 Operating lease liabilities 832 Total operating lease liabilities $ 1,195 |
Future Minimum Commitments Due Under Non-Cancelable Operating Leases | Minimum lease payments were as follows at March 31, 2020 (in thousands): Year Ending December 31, 2020 286 2021 392 2022 407 2023 316 Total minimum lease payments 1,401 Less imputed interest (206 ) Total operating lease liabilities $ 1,195 |
Fair Value Measurements (Tables
Fair Value Measurements (Tables) | 3 Months Ended |
Mar. 31, 2020 | |
Fair Value Disclosures [Abstract] | |
Summary of Assets Measured at Fair Value | The following tables summarize the fair value of financial assets that are measured at fair value and the classification by level of input within the fair value hierarchy (in thousands): March 31, 2020 Level 1 Level 2 Level 3 Recorded Value Financial Assets: Cash and money markets $ 20,930 $ — $ — $ 20,930 Restricted cash money market 360 — — 360 Total financial assets $ 21,290 $ — $ — $ 21,290 December 31, 2019 Level 1 Level 2 Level 3 Recorded Value Financial Assets: Cash and money markets $ 22,595 $ — $ — $ 22,595 Restricted cash money market 360 — — 360 Total financial assets $ 22,955 $ — $ — $ 22,955 |
Net Loss per Share (Tables)
Net Loss per Share (Tables) | 3 Months Ended |
Mar. 31, 2020 | |
Earnings Per Share [Abstract] | |
Potential Common Stock Equivalents Excluded from Computation of Diluted Net Loss per Share | The Company’s potential common stock equivalents that have been excluded from the computation of diluted net loss per share for all periods presented because of their antidilutive effect consisted of the following: Three Months Ended March 31, 2020 2019 Outstanding stock options 4,998,105 4,832,889 Non-vested restricted stock units 1,648,600 — Stock purchase warrants 29,796 29,796 6,676,501 4,862,685 |
The Company - Additional Inform
The Company - Additional Information (Details) - USD ($) $ in Thousands | 3 Months Ended | ||
Mar. 31, 2020 | Dec. 31, 2019 | Mar. 31, 2019 | |
Organization Consolidation And Presentation Of Financial Statements [Abstract] | |||
Entity incorporation date | May 26, 2011 | ||
Cash and cash equivalents | $ 20,930 | $ 22,595 | $ 32,950 |
Property and Equipment, Net - S
Property and Equipment, Net - Schedule of Property and Equipment, Net (Details) - USD ($) $ in Thousands | 3 Months Ended | |
Mar. 31, 2020 | Dec. 31, 2019 | |
Property Plant And Equipment [Line Items] | ||
Property and Equipment, gross | $ 1,193 | $ 1,138 |
Less: Accumulated depreciation | (642) | (597) |
Property and equipment, net | 551 | 541 |
Furniture and Fixtures | ||
Property Plant And Equipment [Line Items] | ||
Property and Equipment, gross | $ 337 | 337 |
Estimated Useful Lives (Years) | 5 years | |
Machinery and Equipment | ||
Property Plant And Equipment [Line Items] | ||
Property and Equipment, gross | $ 176 | 121 |
Estimated Useful Lives (Years) | 5 years | |
Computer Equipment | ||
Property Plant And Equipment [Line Items] | ||
Property and Equipment, gross | $ 13 | 13 |
Estimated Useful Lives (Years) | 3 years | |
Leasehold Improvements | ||
Property Plant And Equipment [Line Items] | ||
Property and Equipment, gross | $ 667 | $ 667 |
Estimated Useful Lives (Years) | Lesser of useful life or remaining lease term |
Accrued Liabilities - Schedule
Accrued Liabilities - Schedule of Accrued Liabilities (Details) - USD ($) $ in Thousands | Mar. 31, 2020 | Dec. 31, 2019 |
Payables And Accruals [Abstract] | ||
Accrued research and development | $ 185 | $ 359 |
Accrued employee costs | 425 | 1,530 |
Accrued severance | 531 | 751 |
Accrued professional fees | 122 | 58 |
Accrued expense | 229 | 232 |
Accrued liabilities, current | $ 1,492 | $ 2,930 |
Long-Term Debt - Additional Inf
Long-Term Debt - Additional Information (Details) - USD ($) | May 07, 2020 | Oct. 18, 2019 | May 14, 2018 | Mar. 31, 2020 | Mar. 31, 2019 |
Debt Instrument [Line Items] | |||||
Interest expense on borrowings | $ 106,000 | $ 225,000 | |||
Accretion of scheduled final payment | 10,000 | 46,000 | |||
Accretion of deferred debt issuance costs | $ 21,000 | $ 15,000 | |||
Second Amended and Restated Loan and Security Agreement | |||||
Debt Instrument [Line Items] | |||||
Long term debt | $ 10,000,000 | ||||
Repayment of outstanding amount under the loan agreement including fees | $ 5,000,000 | ||||
Debt Instrument, Payment Terms | On October 18, 2019, the Company entered into an amendment to the 2nd A&R Loan Agreement with the Lenders. Pursuant to the amendment, the Company repaid $5.0 million of the outstanding principal balance of the $10.0 million term loan. The Company did not pay any final payment or termination fees in connection with the $5.0 million prepayment. In addition, the Company and the Lenders agreed to modify the term loan repayment schedule. As amended, the term loan repayment schedule provides for interest only payments through October 31, 2020, followed by consecutive equal monthly payments of principal and interest in arrears continuing through the maturity date of October 1, 2022. | ||||
Loans held-for-sale, maturity date | Oct. 1, 2022 | ||||
Final payment during maturity | 0.0550 | ||||
Debt instrument final payment | $ 300,000 | ||||
Minimum balance requirement cash and cash equivalents | $ 10,000,000 | ||||
Second Amended and Restated Loan and Security Agreement | Prepayments Through October 1, 2020 | |||||
Debt Instrument [Line Items] | |||||
Prepayment fee percentage of the original principal amount of the aggregate term loans | 2.00% | ||||
Second Amended and Restated Loan and Security Agreement | Subsequent Event | |||||
Debt Instrument [Line Items] | |||||
Debt instrument, principal balance payment | $ 5,000,000 | ||||
Debt Instrument, Final Payment, Interest | $ 300,000 | ||||
Silicon Valley Bank, MidCap Funding III Trust and MidCap Financial Trust | Second Amended and Restated Loan and Security Agreement | |||||
Debt Instrument [Line Items] | |||||
Fixed interest rate | 6.50% | ||||
Variable interest rate | 1.89% | ||||
Debt instrument, description of variable rate basis | 30-day U.S. LIBOR | ||||
Line of credit facility, maximum borrowing capacity | $ 20,000,000 | ||||
Long term debt | 10,000,000 | ||||
Line of credit facility remaining borrowing capacity not available for withdraw | 5,000,000 | ||||
Silicon Valley Bank, MidCap Funding III Trust and MidCap Financial Trust | Second Amended and Restated Loan and Security Agreement | Term C Loan | |||||
Debt Instrument [Line Items] | |||||
Line of credit facility, remaining borrowing capacity description | Of the remaining $10.0 million under the 2nd A&R Loan Agreement, the Company elected not to draw $5.0 million and the other $5.0 million is not available for draw. | ||||
Line of credit facility, remaining borrowing capacity | 5,000,000 | ||||
Silicon Valley Bank, MidCap Funding III Trust and MidCap Financial Trust | Second Amended and Restated Loan and Security Agreement, Initial Tranche | |||||
Debt Instrument [Line Items] | |||||
Long term debt | 10,000,000 | ||||
Silicon Valley Bank , MidCap Funding XII Trust and MidCap Financial Trust | First Amended and Restated Loan and Security Agreement | Final Payment | |||||
Debt Instrument [Line Items] | |||||
Repayment of outstanding amount under the loan agreement including fees | $ 7,000,000 |
Long-Term Debt - Scheduled Paym
Long-Term Debt - Scheduled Payments for the Second Amended and Restated Loan and Security Agreement (Details) - Second Amended and Restated Loan and Security Agreement $ in Thousands | Mar. 31, 2020USD ($) |
Debt Instrument [Line Items] | |
Principal, 2020 | $ 5,000 |
Interest and Final Payment, 2020 | 382 |
Total, 2020 | $ 5,382 |
Common Stock - Additional Infor
Common Stock - Additional Information (Details) - $ / shares | Mar. 31, 2020 | Dec. 31, 2019 |
Equity [Abstract] | ||
Common stock, shares authorized | 100,000,000 | 100,000,000 |
Common stock, par value | $ 0.001 | $ 0.001 |
Common stock, shares outstanding | 44,868,558 | 44,413,372 |
Stock Purchase Warrants - Addit
Stock Purchase Warrants - Additional Information (Details) - Convertible Stock Warrant - $ / shares | 1 Months Ended | 3 Months Ended |
Sep. 30, 2016 | Mar. 31, 2020 | |
Class Of Warrant Or Right [Line Items] | ||
Class of warrant Exercise | $ 10.74 | |
Warrants expiration term | 2026-09 | |
Weighted average remaining life of warrants | 6 years 6 months | |
Maximum | ||
Class Of Warrant Or Right [Line Items] | ||
Number of stock that can be purchased by each warrant | 29,796 |
Share-Based Compensation - Summ
Share-Based Compensation - Summary of Share-based Compensation Expense (Details) - Stock Options - 2011 Stock Incentive Plan, 2016 Equity Incentive Plan - USD ($) $ in Thousands | 3 Months Ended | |
Mar. 31, 2020 | Mar. 31, 2019 | |
Employee Service Share Based Compensation Allocation Of Recognized Period Costs [Line Items] | ||
Share-based compensation expense | $ 719 | $ 1,237 |
Research and Development | ||
Employee Service Share Based Compensation Allocation Of Recognized Period Costs [Line Items] | ||
Share-based compensation expense | 306 | 462 |
General and Administrative | ||
Employee Service Share Based Compensation Allocation Of Recognized Period Costs [Line Items] | ||
Share-based compensation expense | $ 413 | $ 775 |
Share-Based Compensation - Su_2
Share-Based Compensation - Summary of Activity Related to Stock Options (Details) - Stock Options - $ / shares | 3 Months Ended | |
Mar. 31, 2020 | Dec. 31, 2019 | |
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | ||
Number of Shares, Options outstanding, Beginning balance | 4,104,450 | |
Number of Shares, Granted | 903,500 | |
Number of Shares, Forfeited | (9,845) | |
Number of Shares, Options outstanding, Ending balance | 4,998,105 | |
Number of Shares, Options exercisable | 2,782,163 | 2,452,764 |
Weighted Average Exercise Price, Options outstanding, Beginning balance | $ 4.63 | |
Weighted Average Exercise Price, Granted | 2.37 | |
Weighted Average Exercise Price, Forfeited | 3.05 | |
Weighted Average Exercise Price, Options outstanding, Ending balance | 4.23 | |
Weighted Average Exercise Price, Options exercisable | $ 5.14 | $ 5.44 |
Share-Based Compensation - Addi
Share-Based Compensation - Additional Information (Details) - USD ($) | 3 Months Ended | |
Mar. 31, 2020 | Mar. 31, 2019 | |
Two Thousand Sixteen Employee Stock Purchase Plan | ||
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | ||
Share-based compensation expense | $ 3,000 | $ 10,000 |
Stock Options | ||
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | ||
Unrecognized compensation expense related to unvested stock options | $ 5,100,000 | |
Expected to be recognized over a weighted average period | 2 years 7 months 6 days | |
Restricted Stock Units (RSUs) | ||
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | ||
Expected to be recognized over a weighted average period | 2 years 10 months 24 days | |
Share-based compensation expense | $ 300,000 | $ 0 |
Unrecognized compensation expense related to the RSUs | $ 1,600,000 |
Share-Based Compensation - Su_3
Share-Based Compensation - Summary of the Activity Related to RSUs (Details) - Restricted Stock Units (RSUs) | 3 Months Ended |
Mar. 31, 2020$ / sharesshares | |
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | |
Non-vested units outstanding, Number of Shares, Beginning balance | shares | 1,269,300 |
Number of Shares, Granted | shares | 486,000 |
Number of Shares, Vested | shares | (100,000) |
Number of Shares, Forfeited | shares | (6,700) |
Non-vested units outstanding, Number of Shares, Ending balance | shares | 1,648,600 |
Non-vested units outstanding, Weighted Average Exercise Price, Beginning balance | $ / shares | $ 0.87 |
Weighted Average Exercise Price, Granted | $ / shares | 2.39 |
Weighted Average Exercise Price, Vested | $ / shares | 1.02 |
Weighted Average Exercise Price, Forfeited | $ / shares | 0.91 |
Non-vested units outstanding, Weighted Average Exercise Price, Ending balance | $ / shares | $ 1.31 |
Commitment and Contingencies -
Commitment and Contingencies - Additional Information (Details) | 1 Months Ended | 3 Months Ended | |
Nov. 30, 2016USD ($)ft² | Mar. 31, 2020USD ($) | Mar. 31, 2019USD ($) | |
Commitment And Contingencies [Line Items] | |||
Lessee, operating lease, option to extend, description | The renewal option is not included in the calculation of the right-of-use asset and the lease liabilities as the Company has not yet determined if the Alpharetta, Georgia lease will be renewed. | ||
Incremental borrowing rate | 11.00% | ||
Operating lease, remaining lease term | 3 years 6 months | ||
Operating Lease, Cost | $ 62,000 | $ 100,000 | |
Variable Lease, Cost | 24,000 | 30,000 | |
Short-term Lease, Cost | 4,000 | 3,000 | |
Cash payments included in operating activities for operating lease liabilities | $ 92,000 | $ 129,000 | |
GEORGIA | |||
Commitment And Contingencies [Line Items] | |||
Area of office leased | ft² | 20,000 | ||
Operating lease agreement term | 6 years 6 months | ||
Operating lease agreement renewal option term | 5 years | ||
Minimum monthly lease payments | $ 35,145 | ||
Percentage of increase per year | 3.00% |
Commitment and Contingencies _2
Commitment and Contingencies - Operating Leases Included on the Balance Sheet (Details) - USD ($) $ in Thousands | Mar. 31, 2020 | Dec. 31, 2019 |
Commitments And Contingencies Disclosure [Abstract] | ||
Operating lease right-of-use asset | $ 627 | $ 656 |
Liabilities | ||
Current portion of operating lease liabilities | 363 | 360 |
Operating lease liabilities | 832 | $ 897 |
Total operating lease liabilities | $ 1,195 |
Commitment and Contingencies _3
Commitment and Contingencies - Future Minimum Commitments Due Under Non-Cancelable Operating Leases (Details) $ in Thousands | Mar. 31, 2020USD ($) |
Commitments And Contingencies Disclosure [Abstract] | |
2020 | $ 286 |
2021 | 392 |
2022 | 407 |
2023 | 316 |
Total minimum lease payments | 1,401 |
Less imputed interest | (206) |
Total operating lease liabilities | $ 1,195 |
License and Other Agreements -
License and Other Agreements - Additional Information (Detail) - USD ($) | 1 Months Ended | 3 Months Ended | |
Mar. 10, 2020 | Mar. 31, 2020 | Mar. 31, 2019 | |
Research And Development Arrangement Contract To Perform For Others [Line Items] | |||
License and other revenue | $ 4,097,000 | $ 45,000 | |
Other Current Liabilities | |||
Research And Development Arrangement Contract To Perform For Others [Line Items] | |||
Deferred revenue | $ 100,000 | ||
Collaboration Agreements | |||
Research And Development Arrangement Contract To Perform For Others [Line Items] | |||
License and other revenue | $ 45,000 | ||
Maximum | |||
Research And Development Arrangement Contract To Perform For Others [Line Items] | |||
Other short-term collaboration agreements performance obligations period | 2 months | ||
Minimum | |||
Research And Development Arrangement Contract To Perform For Others [Line Items] | |||
Other short-term collaboration agreements performance obligations period | 1 month | ||
Arctic Vision Limited | |||
Research And Development Arrangement Contract To Perform For Others [Line Items] | |||
Amount of upfront payment and development milestones payment to be received under license agreement | $ 35,500,000 | ||
Upfront payment | 4,000,000 | ||
Arctic Vision Limited | Upfront Payment | |||
Research And Development Arrangement Contract To Perform For Others [Line Items] | |||
License and other revenue | $ 4,000,000 | ||
Arctic Vision Limited | Maximum | |||
Research And Development Arrangement Contract To Perform For Others [Line Items] | |||
Development milestone payments | $ 31,500,000 | ||
Threshold percentage of sales for tiered royalties | 12.00% | ||
Arctic Vision Limited | Minimum | |||
Research And Development Arrangement Contract To Perform For Others [Line Items] | |||
Threshold percentage of sales for tiered royalties | 10.00% |
Fair Value Measurements - Addit
Fair Value Measurements - Additional Information (Details) - USD ($) | Mar. 31, 2020 | Dec. 31, 2019 |
Fair Value Disclosures [Abstract] | ||
Significant transfers between Levels 1, 2 and 3 | $ 0 | $ 0 |
Fair Value Measurements - Summa
Fair Value Measurements - Summary of Assets Measured at Fair Value (Details) - USD ($) $ in Thousands | Mar. 31, 2020 | Dec. 31, 2019 |
Financial Assets: | ||
Total financial assets | $ 21,290 | $ 22,955 |
Level 1 | ||
Financial Assets: | ||
Total financial assets | 21,290 | 22,955 |
Cash and Money Markets | ||
Financial Assets: | ||
Total financial assets | 20,930 | 22,595 |
Cash and Money Markets | Level 1 | ||
Financial Assets: | ||
Total financial assets | 20,930 | 22,595 |
Restricted Cash Money Market | ||
Financial Assets: | ||
Total financial assets | 360 | 360 |
Restricted Cash Money Market | Level 1 | ||
Financial Assets: | ||
Total financial assets | $ 360 | $ 360 |
Net Loss Per Share - Potential
Net Loss Per Share - Potential Common Stock Equivalents Excluded from Computation of Diluted Net Loss per Share (Details) - shares | 3 Months Ended | |
Mar. 31, 2020 | Mar. 31, 2019 | |
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] | ||
Antidilutive securities excluded from computation of earnings per share | 6,676,501 | 4,862,685 |
Outstanding Stock Options | ||
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] | ||
Antidilutive securities excluded from computation of earnings per share | 4,998,105 | 4,832,889 |
Non-vested Restricted Stock Units | ||
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] | ||
Antidilutive securities excluded from computation of earnings per share | 1,648,600 | |
Stock Purchase Warrants | ||
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] | ||
Antidilutive securities excluded from computation of earnings per share | 29,796 | 29,796 |
Subsequent Events - Additional
Subsequent Events - Additional Information (Details) - Subsequent Event - USD ($) | May 07, 2020 | Apr. 27, 2020 | Apr. 20, 2020 |
Second Amended and Restated Loan and Security Agreement | |||
Subsequent Event [Line Items] | |||
Debt instrument, principal balance payment | $ 5,000,000 | ||
Debt Instrument, final payment, Interest | $ 300,000 | ||
Silicon Valley Bank | PPP Loan | |||
Subsequent Event [Line Items] | |||
Aggregate principal amount | $ 1,000,000 | ||
Interest rate on outstanding principal amount | 1.00% | ||
Note, term | 2 years | ||
Minimum [Member] | Silicon Valley Bank | PPP Loan | |||
Subsequent Event [Line Items] | |||
Eligible Payroll Costs | 75.00% | ||
Commercial Arrangement | Maximum | |||
Subsequent Event [Line Items] | |||
Pre-launch milestone payments | $ 15,000,000 | ||
Additional milestone payments | 57,300,000 | ||
Bausch Health Ireland Limited | |||
Subsequent Event [Line Items] | |||
Upfront payment | 5,000,000 | ||
First cumulative net sales of products | $ 45,000,000 |