Document and Entity Information
Document and Entity Information - shares | 9 Months Ended | |
Sep. 30, 2019 | Nov. 04, 2019 | |
Cover [Abstract] | ||
Entity Registrant Name | Clearside Biomedical, Inc. | |
Amendment Flag | false | |
Document Period End Date | Sep. 30, 2019 | |
Document Fiscal Year Focus | 2019 | |
Document Fiscal Period Focus | Q3 | |
Trading Symbol | CLSD | |
Document Type | 10-Q | |
Entity Central Index Key | 0001539029 | |
Current Fiscal Year End Date | --12-31 | |
Entity Filer Category | 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 $0.001 per share | |
Security Exchange Name | NASDAQ | |
Entity Incorporation, State or Country Code | DE | |
Document Quarterly Report | true | |
Entity Common Stock, Shares Outstanding | 41,149,781 | |
Entity Shell Company | false | |
Entity Current Reporting Status | Yes | |
Entity File Number | 001-37783 | |
Entity Tax Identification Number | 45-2437375 | |
Entity Address, Address Line One | 900 North Point Parkway | |
Entity Address, Address Line Two | Suite 200 | |
Entity Address, City or Town | Alpharetta | |
Entity Address, State or Province | GA | |
Entity Address, Postal Zip Code | 30005 | |
City Area Code | 678 | |
Local Phone Number | 270-3631 |
Balance Sheets
Balance Sheets - USD ($) $ in Thousands | Sep. 30, 2019 | Dec. 31, 2018 |
Current assets: | ||
Cash and cash equivalents | $ 22,551 | $ 8,043 |
Short-term investments | 32,835 | |
Prepaid expenses | 1,468 | 2,049 |
Other current assets | 27 | 17 |
Total current assets | 24,046 | 42,944 |
Property and equipment, net | 655 | 790 |
Operating lease right-of-use asset | 806 | |
Restricted cash | 360 | 360 |
Other assets | 26 | |
Total assets | 25,867 | 44,120 |
Current liabilities: | ||
Accounts payable | 1,429 | 6,869 |
Accrued liabilities | 2,698 | 2,923 |
Current portion of long-term debt | 5,833 | 556 |
Current portion of operating lease liabilities | 483 | |
Current portion of deferred rent | 128 | |
Other current liabilities | 375 | |
Total current liabilities | 10,818 | 10,476 |
Long-term debt | 4,329 | 9,419 |
Operating lease liabilities | 961 | |
Deferred rent | 605 | |
Total liabilities | 16,108 | 20,500 |
Commitments and contingencies | ||
Stockholders’ equity: | ||
Preferred stock, $0.001 par value; 10,000,000 shares authorized and no shares issued at September 30, 2019 and December 31, 2018 | ||
Common stock, $0.001 par value; 100,000,000 shares authorized at September 30, 2019 and December 31, 2018; 41,149,781 and 32,119,227 shares issued and outstanding at September 30, 2019 and December 31, 2018, respectively | 41 | 32 |
Additional paid-in capital | 244,279 | 230,475 |
Accumulated deficit | (234,561) | (206,887) |
Total stockholders’ equity | 9,759 | 23,620 |
Total liabilities and stockholders’ equity | $ 25,867 | $ 44,120 |
Balance Sheets (Parenthetical)
Balance Sheets (Parenthetical) - $ / shares | Sep. 30, 2019 | Dec. 31, 2018 |
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 | 41,149,781 | 32,119,227 |
Common stock, shares outstanding | 41,149,781 | 32,119,227 |
Statements of Operations
Statements of Operations - USD ($) $ in Thousands | 3 Months Ended | 9 Months Ended | ||
Sep. 30, 2019 | Sep. 30, 2018 | Sep. 30, 2019 | Sep. 30, 2018 | |
Income Statement [Abstract] | ||||
Collaboration revenue | $ 141 | $ 231 | ||
Type of Revenue [Extensible List] | clsd:CollaborationMember | clsd:CollaborationMember | clsd:CollaborationMember | clsd:CollaborationMember |
Operating expenses: | ||||
Research and development | $ 2,728 | $ 20,083 | $ 14,353 | $ 50,805 |
General and administrative | 3,781 | 3,873 | 13,169 | 10,508 |
Total operating expenses | 6,509 | 23,956 | 27,522 | 61,313 |
Loss from operations | (6,368) | (23,956) | (27,291) | (61,313) |
Other (expense) income, net | (168) | 84 | (383) | 133 |
Net loss | $ (6,536) | $ (23,872) | $ (27,674) | $ (61,180) |
Net loss per share of common stock — basic and diluted | $ (0.17) | $ (0.75) | $ (0.75) | $ (2.02) |
Weighted average shares outstanding — basic and diluted | 38,414,751 | 32,024,223 | 36,747,314 | 30,292,909 |
Statement of Stockholders' Equi
Statement of Stockholders' Equity - USD ($) $ in Thousands | Total | Common Stock | Additional Paid-In-Capital | Accumulated Deficit | Accumulated Other Comprehensive Loss |
Beginning balance at Dec. 31, 2017 | $ 21,415 | $ 25 | $ 145,618 | $ (124,220) | $ (8) |
Beginning balance, shares at Dec. 31, 2017 | 25,354,651 | ||||
Cumulative effect of accounting change | 159 | 151 | 8 | ||
Issuance of common shares from follow-on public offering | 79,581 | $ 7 | 79,574 | ||
Issuance of common stock for follow-on public offering, shares | 6,538,462 | ||||
Exercise of stock options | 237 | 237 | |||
Exercise of stock options, shares | 53,920 | ||||
Share-based compensation expense | 1,138 | 1,138 | |||
Net loss | (16,607) | (16,607) | |||
Ending balance at Mar. 31, 2018 | 85,923 | $ 32 | 226,567 | (140,676) | |
Ending balance, shares at Mar. 31, 2018 | 31,947,033 | ||||
Beginning balance at Dec. 31, 2017 | 21,415 | $ 25 | 145,618 | (124,220) | $ (8) |
Beginning balance, shares at Dec. 31, 2017 | 25,354,651 | ||||
Net loss | (61,180) | ||||
Ending balance at Sep. 30, 2018 | 44,076 | $ 32 | 229,293 | (185,249) | |
Ending balance, shares at Sep. 30, 2018 | 32,024,223 | ||||
Beginning balance at Mar. 31, 2018 | 85,923 | $ 32 | 226,567 | (140,676) | |
Beginning balance, shares at Mar. 31, 2018 | 31,947,033 | ||||
Issuance of common shares under employee stock purchase plan | 45 | 45 | |||
Issuance of common shares under employee stock purchase plan, shares | 7,386 | ||||
Exercise of stock options | 196 | 196 | |||
Exercise of stock options, shares | 69,804 | ||||
Share-based compensation expense | 1,199 | 1,199 | |||
Net loss | (20,701) | (20,701) | |||
Ending balance at Jun. 30, 2018 | 66,662 | $ 32 | 228,007 | (161,377) | |
Ending balance, shares at Jun. 30, 2018 | 32,024,223 | ||||
Share-based compensation expense | 1,286 | 1,286 | |||
Net loss | (23,872) | (23,872) | |||
Ending balance at Sep. 30, 2018 | 44,076 | $ 32 | 229,293 | (185,249) | |
Ending balance, shares at Sep. 30, 2018 | 32,024,223 | ||||
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 at-the-market sales agreement | 6,627 | $ 5 | 6,622 | ||
Issuance of common shares from at-the-market sales agreement, 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, 2018 | 23,620 | $ 32 | 230,475 | (206,887) | |
Beginning balance, shares at Dec. 31, 2018 | 32,119,227 | ||||
Net loss | (27,674) | ||||
Ending balance at Sep. 30, 2019 | 9,759 | $ 41 | 244,279 | (234,561) | |
Ending balance, shares at Sep. 30, 2019 | 41,149,781 | ||||
Beginning balance at Mar. 31, 2019 | 16,091 | $ 37 | 238,345 | (222,291) | |
Beginning balance, shares at Mar. 31, 2019 | 36,782,920 | ||||
Issuance of common shares from at-the-market sales agreement | 1,273 | $ 1 | 1,272 | ||
Issuance of common shares from at-the-market sales agreement, shares | 945,974 | ||||
Issuance of common shares under employee stock purchase plan | 15 | 15 | |||
Issuance of common shares under employee stock purchase plan, shares | 17,252 | ||||
Share-based compensation expense | 1,256 | 1,256 | |||
Net loss | (5,734) | (5,734) | |||
Ending balance at Jun. 30, 2019 | 12,901 | $ 38 | 240,888 | (228,025) | |
Ending balance, shares at Jun. 30, 2019 | 37,746,146 | ||||
Issuance of common shares from at-the-market sales agreement | 2,419 | $ 3 | 2,416 | ||
Issuance of common shares from at-the-market sales agreement, shares | 3,370,000 | ||||
Exercise of stock options | 5 | 5 | |||
Exercise of stock options, shares | 13,635 | ||||
Vesting of restricted stock units, shares | 20,000 | ||||
Share-based compensation expense | 970 | 970 | |||
Net loss | (6,536) | (6,536) | |||
Ending balance at Sep. 30, 2019 | $ 9,759 | $ 41 | $ 244,279 | $ (234,561) | |
Ending balance, shares at Sep. 30, 2019 | 41,149,781 |
Statements of Cash Flows
Statements of Cash Flows - USD ($) $ in Thousands | 9 Months Ended | |
Sep. 30, 2019 | Sep. 30, 2018 | |
Operating activities | ||
Net loss | $ (27,674) | $ (61,180) |
Adjustments to reconcile net loss to net cash used in operating activities: | ||
Depreciation | 160 | 141 |
Share-based compensation expense | 3,473 | 3,623 |
Non-cash interest expense | 141 | 107 |
Accretion of debt discount | 46 | 95 |
Amortization and accretion on available-for-sale investments, net | (115) | (514) |
Changes in operating assets and liabilities: | ||
Prepaid expenses and other current assets | 571 | (1,686) |
Other assets and liabilities | 306 | (81) |
Accounts payable and accrued liabilities | (5,665) | 4,554 |
Net cash used in operating activities | (28,757) | (54,941) |
Investing activities | ||
Maturities of available-for-sale investments | 32,950 | 59,970 |
Purchase of available-for-sale investments | (80,137) | |
Acquisition of property and equipment | (25) | (34) |
Net cash provided by (used in) investing activities | 32,925 | (20,201) |
Financing activities | ||
Proceeds from at-the-market sales agreement, net of issuance costs | 10,319 | |
Proceeds from follow-on public offering, net of issuance costs | 79,581 | |
Proceeds from exercise of stock options | 6 | 433 |
Proceeds from shares issued under employee stock purchase plan | 15 | 45 |
Proceeds from long-term debt | 10,000 | |
Payments made on long-term debt | (8,300) | |
Net cash provided by financing activities | 10,340 | 81,759 |
Net increase in cash, cash equivalents and restricted cash | 14,508 | 6,617 |
Cash, cash equivalents and restricted cash, beginning of period | 8,403 | 9,584 |
Cash, cash equivalents and restricted cash, end of period | 22,911 | 16,201 |
Reconciliation of cash, cash equivalents and restricted cash | ||
Cash and cash equivalents | 22,551 | 15,841 |
Restricted cash | 360 | 360 |
Cash, cash equivalents and restricted cash, end of period | $ 22,911 | $ 16,201 |
The Company
The Company | 9 Months Ended |
Sep. 30, 2019 | |
Organization Consolidation And Presentation Of Financial Statements [Abstract] | |
The Company | 1. The Company Clearside Biomedical, Inc. (the “Company”) is a clinical biopharmaceutical company developing first-in-class pharmacological therapies to restore and preserve vision for people with serious eye diseases. The Company’s current product candidates focus on treatments for diseases affecting the retina and choroid and are injected into the suprachoroidal space (“SCS”) using its proprietary SCS Microinjector™. 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, raising capital 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. 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, 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 has funded its operations primarily through the sale of convertible preferred stock and common stock and the issuance of long-term debt. On June 30, 2017, the Company entered into an at-the-market sales agreement (“the ATM agreement”) with Cowen and Company LLC (“Cowen”) under which the Company may offer and sell, from time to time at its sole discretion, shares of its common stock having an aggregate offering price of up to $50.0 million through Cowen acting as sales agent. During the nine months ended September 30, 2019, the Company sold 9.0 million shares of its common stock for net proceeds of $10.3 million under the ATM agreement. The Company’s registration statement on Form S- 3 contemplated under the ATM agreement was declared effective by the SEC on July 13, 2017. The registration statement on Form S- 3 includes a prospectus supplement covering the offering up to $18.5 million of shares of common stock over the 12 months ending March 15, 2020 in accordance with the ATM agreement. On October 22, 2019, the Company entered into a License Agreement (the “License Agreement”) with Bausch Health Ireland Limited (“Bausch”). Under the License Agreement, the Company has granted an exclusive license to Bausch for the commercialization and development of XIPERE TM Subsequent Events In connection with the entry by the Company into the License Agreement, on October 18, 2019, the Company entered into a Third Amendment to Second Amended and Restated Loan and Security Agreement (the “3 rd rd Long-Term Debt ). The Company will need to obtain additional resources to fund future operations, including to conduct additional clinical trials and to complete the development of its product candidates. If any such products were to receive regulatory approval, the Company may need to prepare for the potential commercialization of its product candidates, which could include additional collaborations with third parties for the commercial launch of the products. The Company had cash and cash equivalents of $22.6 million as of September 30, 2019. 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 approval from the U.S. Food and Drug Administration (the “FDA”) to market and then generate significant revenue from any of its product candidates. The Company will need additional resources to fund its operations and Based on its current license agreements, research and development plans and forecasted expenses, the Company expects that its existing cash and cash equivalents as of the filing date, November 8, 2019, will enable it to fund its operating expenses and capital expenditure requirements into the third quarter of 2020. The Company’s ability to fund its operations into the third quarter of 2020 gives effect to the potential restriction of cash pursuant to the Second Amended and Restated Loan and Security Agreement, as amended by the 3 rd 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 | 9 Months Ended |
Sep. 30, 2019 | |
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 September 30, 2019, statements of operations for the three and nine months ended September 30, 2019 and 2018, statements of stockholders’ equity for the three and nine months ended September 30, 2019 and 2018 and statements of cash flows for the nine months ended September 30, 2019 and 2018 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 September 30, 2019, its results of its operations for the three and nine months ended September 30, 2019 and 2018, its changes in stockholders’ equity for the three and nine months ended September 30, 2019 and 2018 and its cash flows for the nine months ended September 30, 2019 and 2018. The financial data and other information disclosed in these notes related to the three and nine months ended September 30, 2019 and 2018 are unaudited. The results for the nine months ended September 30, 2019 are not indicative of results to be expected for the year ending December 31, 2019, 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, 2018. 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. 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 nonclinical 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. Short-Term Investments Short-term investments are investments with original maturities of between 90 and 365 days when purchased and are comprised of commercial paper and treasury bills. The Company classifies its short-term investments as available-for-sale securities. Short-term investments are recorded at fair value and unrealized gains and losses are recorded within interest income. In addition, the Company evaluates the short-investments with unrealized losses to determine whether such losses are other-than-temporary. 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 In February 2016, the Financial Accounting Standards Board (“FASB”) issued Accounting Standards Update (“ASU”) 2016-02, Leases (ASC 842), Leases, Targeted Improvements In June 2018, the FASB issued ASU 2018-07, Compensation-Stock Compensation: Improvements to Nonemployee Shared-Based Payment Accounting The Company adopted ASU 2018-07 effective January 1, 2019, and the adoption did not have a material impact on its financial statements and related disclosures. |
Property and Equipment, Net
Property and Equipment, Net | 9 Months Ended |
Sep. 30, 2019 | |
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) September 30, 2019 December 2018 Furniture and fixtures 5 $ 400 $ 382 Machinery and equipment 5 121 121 Computer equipment 3 19 19 Leasehold improvements Lesser of useful life remaining lease term 684 677 1,224 1,199 Less: Accumulated depreciation (569 ) (409 ) $ 655 $ 790 |
Accrued Liabilities
Accrued Liabilities | 9 Months Ended |
Sep. 30, 2019 | |
Payables And Accruals [Abstract] | |
Accrued Liabilities | 4. Accrued Liabilities Accrued liabilities consisted of the following (in thousands): September 30, December 2019 2018 Accrued research and development $ 403 $ 1,263 Accrued employee costs 1,950 1,191 Accrued marketing 31 47 Accrued professional fees 178 63 Accrued interest payable — 76 Accrued expense 136 283 $ 2,698 $ 2,923 |
Long-Term Debt
Long-Term Debt | 9 Months Ended |
Sep. 30, 2019 | |
Debt Disclosure [Abstract] | |
Long-Term Debt | 5. Long-Term Debt Loan and Security Agreements In September 2016, the Company entered into an amended and restated loan and security agreement, which was subsequently amended on October 31, 2017 (as amended, the “1 st st Under the terms of the 1 st st st On May 14, 2018, the Company entered into a second amended and restated loan and security agreement (the “2 nd st 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 1 st Of the remaining $10.0 million under the 2 nd As of September 30, 2019, the Company was required to pay accrued interest only on the $10 million borrowed under the 2 nd followed by consecutive equal monthly payments of principal and interest in arrears continuing through the maturity date of October 1, 2022 2 The borrowings under the 2 nd On October 18, 2019, the Company entered into the 3 rd rd rd Interest expense on the borrowings under the loan agreements described above was $223,000 and $220,000 for the three months ended September 30, 2019 and 2018, respectively, and $676,000 and $566,000 for the nine months ended September 30, 2019 and 2018, respectively. Accretion of the scheduled final payment was $47,000 for each of the three months ended September 30, 2019 and 2018, and $141,000 and $107,000 for the nine months ended September 30, 2019 and 2018, respectively. Accretion of the deferred debt issuance costs was $16,000 for each of the three months ended September 30, 2019 and 2018, and $47,000 and $95,000 for the nine months ended September 30, 2019 and 2018, respectively. As of September 30, 2019, the scheduled payments for the 2nd A&R Loan Agreement, as amended, and the scheduled final payment in 2022, were as follows (in thousands): Year Ending December 31, Principal Interest and Final Total 2019 $ 5,000 $ 107 $ 5,107 2020 1,333 392 1,725 2021 2,000 234 2,234 2022 1,667 405 2,072 $ 10,000 $ 1,138 $ 11,138 |
Common Stock
Common Stock | 9 Months Ended |
Sep. 30, 2019 | |
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 September 30, 2019 and December 31, 2018, there were 41,149,781 and 32,119,227 shares of common stock outstanding, respectively. |
Stock Purchase Warrants
Stock Purchase Warrants | 9 Months Ended |
Sep. 30, 2019 | |
Stock Purchase Warrants [Abstract] | |
Stock Purchase Warrants | 7. Stock Purchase Warrants In September 2016, in connection with the 1 st Long-Term Debt . |
Share-Based Compensation
Share-Based Compensation | 9 Months Ended |
Sep. 30, 2019 | |
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 September 30, Nine Months Ended September 30, 2019 2018 2019 2018 Research and development $ 243 $ 491 $ 1,066 $ 1,365 General and administrative 543 791 2,166 2,246 Total $ 786 $ 1,282 $ 3,232 $ 3,611 The following table summarizes the activity related to stock options during the nine months ended September 30, 2019: Weighted Number of Average Shares Exercise Price Options outstanding at December 31, 2018 3,463,096 $ 6.62 Granted 1,892,600 1.26 Exercised (16,362 ) 0.40 Forfeited (1,146,450 ) 5.00 Options outstanding at September 30, 2019 4,192,884 4.67 Options exercisable at December 31, 2018 1,583,749 5.63 Options exercisable at September 30, 2019 2,204,649 5.61 As of September 30, 2019, the Company had $5.0 million of unrecognized compensation expense related to unvested stock options, which is expected to be recognized over a weighted average period of 2.4 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 two 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 nine months ended September 30, 2019: Weighted Number of Average Shares Exercise Price Non-vested RSUs outstanding at December 31, 2018 — $ — Granted 1,339,300 0.88 Vested (20,000 ) 1.09 Non-vested RSUs outstanding at September 30, 2019 1,319,300 0.88 The Company recorded $45,000 and $0.2 million of share-based compensation expense for the three and nine months ended September 30, 2019, respectively, for the RSUs. As of September 30, 2019, the Company had $1.0 million of unrecognized compensation expense related to the RSUs, which is expected to be recognized over a weighted average period of 1.4 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 first offering period for the 2016 ESPP commenced January 1, 2017. 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 issued a total of 39,539 shares of common stock purchased under the 2016 ESPP. The Company has recorded $2,000 and $4,000 of share-based compensation expense for the three months ended September 30, 2019 and 2018, respectively, and $15,000 and $12,000 for the nine months ended September 30, 2019 and 2018, 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 | 9 Months Ended |
Sep. 30, 2019 | |
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 relocated to this space in March 2017. In August 2018, the Company signed an office lease agreement to lease approximately 3,500 square feet of office space in Berkeley, California for its commercial operations. The lease agreement is for a two-year term with a renewal option for an additional one-year term. The Company has determined that it will not exercise the renewal option for the Berkeley lease. Rental payments are $12,775 per month subject to a 3% increase per year. Rent expense under this lease is recognized on a straight-line basis over the term of the lease. The Company will pay a 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): September 30, 2019 Operating lease right-of-use asset $ 806 Liabilities Current portion of operating lease liabilities $ 483 Operating lease liabilities 961 Total operating lease liabilities $ 1,444 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 September 30, 2019, the Company’s weighted average discount rate was 5.3% and the weighted average lease term was 2.4 years. Total future undiscounted minimum lease payments were as follows at September 30, 2019 (in thousands): Year Ending December 31, 2019 $ 157 2020 574 2021 496 2022 511 2023 393 Total minimum lease payments $ 2,131 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. Rent expense was $100,000 and $79,000 for the three months ended September 30, 2019 and 2018, respectively, and $300,000 and $195,000 for the nine months ended September 30, 2019 and 2018, respectively. Cash payments included in operating activities on the statement of cash flows for operating lease liabilities were $386,000 for the nine months ended September 30, 2019. 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. |
Collaboration Agreements
Collaboration Agreements | 9 Months Ended |
Sep. 30, 2019 | |
Collaboration Agreements [Abstract] | |
Collaboration Agreements | 10. Collaboration Agreements The Company has periodically entered into other short-term collaboration 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 collaboration agreements are recognized as revenue over the term of the agreement. The Company recorded $141,000 and $231,000 of revenue from these collaboration agreements during the three and nine months ended September 30, 2019, respectively. In addition, the Company recorded $0.4 million of deferred revenue in other current liabilities from these collaboration agreements as of September 30, 2019. |
Fair Value Measurements
Fair Value Measurements | 9 Months Ended |
Sep. 30, 2019 | |
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 September 30, 2019 and December 31, 2018 consisted primarily of cash and cash equivalents, short-term investments 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. The Company has determined its short-term investments, comprised of commercial paper, to be Level 2 in the fair value hierarchy. The fair value was determined using a market approach, based on prices and other relevant information generated by market transactions involving similar assets. The short-term investments consist of investments with original maturity dates from date of acquisition of 90 to 365 days and are classified as available-for-sale. There were no significant transfers between Levels 1, 2 and 3 during the nine months ended September 30, 2019 and the year ended December 31, 2018. 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): September 30, 2019 Level 1 Level 2 Level 3 Recorded Value Financial Assets: Cash and money markets $ 22,551 $ — $ — $ 22,551 Restricted cash money market 360 — — 360 Total financial assets $ 22,911 $ — $ — $ 22,911 December 31, 2018 Level 1 Level 2 Level 3 Recorded Value Financial Assets: Cash and money markets $ 8,042 $ — $ — $ 8,042 Restricted cash money market 360 — — 360 Treasury bills 7,490 — — 7,490 Commercial paper — 25,346 — 25,346 Total financial assets $ 15,892 $ 25,346 $ — $ 41,238 |
Net Loss per Share
Net Loss per Share | 9 Months Ended |
Sep. 30, 2019 | |
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 September 30, Nine Months Ended September 30, 2019 2018 2019 2018 Outstanding stock options 4,192,884 3,220,500 4,192,884 3,220,500 Non-vested restricted stock units 1,319,300 — 1,319,300 — Stock purchase warrants 29,796 29,796 29,796 29,796 5,541,980 3,250,296 5,541,980 3,250,296 |
Subsequent Events
Subsequent Events | 9 Months Ended |
Sep. 30, 2019 | |
Subsequent Events [Abstract] | |
Subsequent Events | 13. Subsequent Events License Agreement On October 22, 2019, the Company entered into the License Agreement with Bausch. Pursuant to the License Agreement, the Company has granted an exclusive license to Bausch to develop, manufacture, distribute, promote, market and commercialize XIPERE using the Company’s proprietary microneedle (the “Device”), as well as specified other steroids, corticosteroids and NSAIDs in combination with the Device (“Other Products”), subject to specified exceptions, in the United States and Canada for the treatment of ophthalmology indications, including non-infectious uveitis. Pursuant to the License Agreement, Bausch made an upfront payment of $5.0 million, which is subject to a refund if the 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 and up to an aggregate of $56.0 million in additional milestone payments upon the achievement of (i) specified regulatory approvals for specified additional indications of XIPERE and (ii) specified levels of annual net sales (as defined in the 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 the achievement of certain annual net sales thresholds in the United States and Canada, as well as a lower royalty on annual net sales of Other Products, in each case subject to reductions in specified circumstances; provided that the Company will not receive any royalties on the first $30.0 million of cumulative net sales of all products. The Company is responsible for all development expenses for XIPERE until the Company’s New Drug Application (“NDA”) for XIPERE NDA Amendments to Loan and Security Agreement On October 18, 2019, the Company entered into a 3 rd the 3 rd Long-Term Debt ). On October 18, 2019, the Company entered into a Consent and Fourth Amendment to the 2 nd Agreement (the “4 th th Option and License Agreement On August 29, 2019, the Company entered into an option and license agreement with REGENXBIO, Inc. (“REGENXBIO”) pursuant to which the Company granted REGENXBIO an exclusive option to enter into a commercial license agreement (the “Option”) granting REGENXBIO an exclusive, worldwide and sublicensable license to the Company’s SCS Microinjector for the delivery of adeno-associated virus-based gene therapies for the treatment of wet age-related macular degeneration, diabetic retinopathy and other conditions for which anti-vascular endothelial growth factor |
Significant Accounting Polici_2
Significant Accounting Policies (Policies) | 9 Months Ended |
Sep. 30, 2019 | |
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 September 30, 2019, statements of operations for the three and nine months ended September 30, 2019 and 2018, statements of stockholders’ equity for the three and nine months ended September 30, 2019 and 2018 and statements of cash flows for the nine months ended September 30, 2019 and 2018 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 September 30, 2019, its results of its operations for the three and nine months ended September 30, 2019 and 2018, its changes in stockholders’ equity for the three and nine months ended September 30, 2019 and 2018 and its cash flows for the nine months ended September 30, 2019 and 2018. The financial data and other information disclosed in these notes related to the three and nine months ended September 30, 2019 and 2018 are unaudited. The results for the nine months ended September 30, 2019 are not indicative of results to be expected for the year ending December 31, 2019, 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, 2018. |
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. |
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 nonclinical 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. |
Short-Term Investments | Short-Term Investments Short-term investments are investments with original maturities of between 90 and 365 days when purchased and are comprised of commercial paper and treasury bills. The Company classifies its short-term investments as available-for-sale securities. Short-term investments are recorded at fair value and unrealized gains and losses are recorded within interest income. In addition, the Company evaluates the short-investments with unrealized losses to determine whether such losses are other-than-temporary. |
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 In February 2016, the Financial Accounting Standards Board (“FASB”) issued Accounting Standards Update (“ASU”) 2016-02, Leases (ASC 842), Leases, Targeted Improvements In June 2018, the FASB issued ASU 2018-07, Compensation-Stock Compensation: Improvements to Nonemployee Shared-Based Payment Accounting The Company adopted ASU 2018-07 effective January 1, 2019, and the adoption did not have a material impact on its financial statements and related disclosures. |
Property and Equipment, Net (Ta
Property and Equipment, Net (Tables) | 9 Months Ended |
Sep. 30, 2019 | |
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) September 30, 2019 December 2018 Furniture and fixtures 5 $ 400 $ 382 Machinery and equipment 5 121 121 Computer equipment 3 19 19 Leasehold improvements Lesser of useful life remaining lease term 684 677 1,224 1,199 Less: Accumulated depreciation (569 ) (409 ) $ 655 $ 790 |
Accrued Liabilities (Tables)
Accrued Liabilities (Tables) | 9 Months Ended |
Sep. 30, 2019 | |
Payables And Accruals [Abstract] | |
Schedule of Accrued Liabilities | Accrued liabilities consisted of the following (in thousands): September 30, December 2019 2018 Accrued research and development $ 403 $ 1,263 Accrued employee costs 1,950 1,191 Accrued marketing 31 47 Accrued professional fees 178 63 Accrued interest payable — 76 Accrued expense 136 283 $ 2,698 $ 2,923 |
Long-Term Debt (Tables)
Long-Term Debt (Tables) | 9 Months Ended |
Sep. 30, 2019 | |
Second Amended and Restated Loan and Security Agreement | |
Scheduled Payments for the Second Amended and Restated Loan and Security Agreement | As of September 30, 2019, the scheduled payments for the 2nd A&R Loan Agreement, as amended, and the scheduled final payment in 2022, were as follows (in thousands): Year Ending December 31, Principal Interest and Final Total 2019 $ 5,000 $ 107 $ 5,107 2020 1,333 392 1,725 2021 2,000 234 2,234 2022 1,667 405 2,072 $ 10,000 $ 1,138 $ 11,138 |
Share-Based Compensation (Table
Share-Based Compensation (Tables) | 9 Months Ended |
Sep. 30, 2019 | |
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | |
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 September 30, Nine Months Ended September 30, 2019 2018 2019 2018 Research and development $ 243 $ 491 $ 1,066 $ 1,365 General and administrative 543 791 2,166 2,246 Total $ 786 $ 1,282 $ 3,232 $ 3,611 |
Summary of Activity Related to Stock Options | The following table summarizes the activity related to stock options during the nine months ended September 30, 2019: Weighted Number of Average Shares Exercise Price Options outstanding at December 31, 2018 3,463,096 $ 6.62 Granted 1,892,600 1.26 Exercised (16,362 ) 0.40 Forfeited (1,146,450 ) 5.00 Options outstanding at September 30, 2019 4,192,884 4.67 Options exercisable at December 31, 2018 1,583,749 5.63 Options exercisable at September 30, 2019 2,204,649 5.61 |
Restricted Stock Units | |
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | |
Summary of the Activity Related to RSUs | The following table summarizes the activity related to RSUs during the nine months ended September 30, 2019: Weighted Number of Average Shares Exercise Price Non-vested RSUs outstanding at December 31, 2018 — $ — Granted 1,339,300 0.88 Vested (20,000 ) 1.09 Non-vested RSUs outstanding at September 30, 2019 1,319,300 0.88 |
Commitment and Contingencies (T
Commitment and Contingencies (Tables) | 9 Months Ended |
Sep. 30, 2019 | |
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): September 30, 2019 Operating lease right-of-use asset $ 806 Liabilities Current portion of operating lease liabilities $ 483 Operating lease liabilities 961 Total operating lease liabilities $ 1,444 |
Total Future Undiscounted Minimum Lease Payments | Total future undiscounted minimum lease payments were as follows at September 30, 2019 (in thousands): Year Ending December 31, 2019 $ 157 2020 574 2021 496 2022 511 2023 393 Total minimum lease payments $ 2,131 |
Fair Value Measurements (Tables
Fair Value Measurements (Tables) | 9 Months Ended |
Sep. 30, 2019 | |
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): September 30, 2019 Level 1 Level 2 Level 3 Recorded Value Financial Assets: Cash and money markets $ 22,551 $ — $ — $ 22,551 Restricted cash money market 360 — — 360 Total financial assets $ 22,911 $ — $ — $ 22,911 December 31, 2018 Level 1 Level 2 Level 3 Recorded Value Financial Assets: Cash and money markets $ 8,042 $ — $ — $ 8,042 Restricted cash money market 360 — — 360 Treasury bills 7,490 — — 7,490 Commercial paper — 25,346 — 25,346 Total financial assets $ 15,892 $ 25,346 $ — $ 41,238 |
Net Loss per Share (Tables)
Net Loss per Share (Tables) | 9 Months Ended |
Sep. 30, 2019 | |
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 September 30, Nine Months Ended September 30, 2019 2018 2019 2018 Outstanding stock options 4,192,884 3,220,500 4,192,884 3,220,500 Non-vested restricted stock units 1,319,300 — 1,319,300 — Stock purchase warrants 29,796 29,796 29,796 29,796 5,541,980 3,250,296 5,541,980 3,250,296 |
The Company - Additional Inform
The Company - Additional Information (Details) - USD ($) | Oct. 22, 2019 | Oct. 18, 2019 | Jul. 13, 2017 | Jun. 30, 2017 | Sep. 30, 2019 | Dec. 31, 2018 | Sep. 30, 2018 |
Organization Consolidation and Presentation of Financial Statements Disclosure [Line Items] | |||||||
Entity incorporation date | May 26, 2011 | ||||||
Cash and cash equivalents | $ 22,551,000 | $ 8,043,000 | $ 15,841,000 | ||||
Subsequent Event | Third Amended and Restated Loan and Security Agreement | |||||||
Organization Consolidation and Presentation of Financial Statements Disclosure [Line Items] | |||||||
Repayment of outstanding amount under the loan agreement including fees | $ 5,000,000 | ||||||
Long term debt | 10,000,000 | ||||||
Minimum balance requirement cash and cash equivalents | 10,000,000 | ||||||
Debt instrument final payment | $ 340,441 | ||||||
Subsequent Event | Bausch Health Ireland Limited | License Agreement Terms | |||||||
Organization Consolidation and Presentation of Financial Statements Disclosure [Line Items] | |||||||
Upfront payment received under the license agreement | $ 5,000,000 | ||||||
At-the-market sales agreement | Cowen and Company LLC | Common Stock | |||||||
Organization Consolidation and Presentation of Financial Statements Disclosure [Line Items] | |||||||
Number of shares sold under facility | 9,000,000 | ||||||
Net proceeds from issuance of stock | $ 10,300,000 | ||||||
At-the-market sales agreement | Cowen and Company LLC | Common Stock | Maximum | |||||||
Organization Consolidation and Presentation of Financial Statements Disclosure [Line Items] | |||||||
Aggregate offering price, shares | $ 18,500,000 | $ 50,000,000 |
Significant Accounting Polici_3
Significant Accounting Policies - Additional Information (Details) - USD ($) $ in Thousands | 9 Months Ended | |
Sep. 30, 2019 | Jan. 01, 2019 | |
Significant Accounting Policies [Line Items] | ||
Short-term investments maturity start period | 90 days | |
Short-term investments maturity end period | 365 days | |
Recognition of a right-of use asset | $ 806 | |
Recognition of a lease obligations | $ 1,444 | |
ASU 2016-02 | ||
Significant Accounting Policies [Line Items] | ||
Recognition of a right-of use asset | $ 1,000 | |
Recognition of a lease obligations | $ 1,700 |
Property and Equipment, Net - S
Property and Equipment, Net - Schedule of Property and Equipment, Net (Details) - USD ($) $ in Thousands | 9 Months Ended | |
Sep. 30, 2019 | Dec. 31, 2018 | |
Property Plant And Equipment [Line Items] | ||
Property and Equipment, gross | $ 1,224 | $ 1,199 |
Less: Accumulated depreciation | (569) | (409) |
Property and equipment, net | 655 | 790 |
Furniture and Fixtures | ||
Property Plant And Equipment [Line Items] | ||
Property and Equipment, gross | $ 400 | 382 |
Estimated Useful Lives (Years) | 5 years | |
Machinery and Equipment | ||
Property Plant And Equipment [Line Items] | ||
Property and Equipment, gross | $ 121 | 121 |
Estimated Useful Lives (Years) | 5 years | |
Computer Equipment | ||
Property Plant And Equipment [Line Items] | ||
Property and Equipment, gross | $ 19 | 19 |
Estimated Useful Lives (Years) | 3 years | |
Leasehold Improvements | ||
Property Plant And Equipment [Line Items] | ||
Property and Equipment, gross | $ 684 | $ 677 |
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 | Sep. 30, 2019 | Dec. 31, 2018 |
Payables And Accruals [Abstract] | ||
Accrued research and development | $ 403 | $ 1,263 |
Accrued employee costs | 1,950 | 1,191 |
Accrued marketing | 31 | 47 |
Accrued professional fees | 178 | 63 |
Accrued interest payable | 76 | |
Accrued expense | 136 | 283 |
Accrued liabilities, current | $ 2,698 | $ 2,923 |
Long-Term Debt - Additional Inf
Long-Term Debt - Additional Information (Details) - USD ($) | Oct. 18, 2019 | May 14, 2018 | Sep. 28, 2016 | Sep. 30, 2016 | Sep. 30, 2019 | Sep. 30, 2018 | Sep. 30, 2019 | Sep. 30, 2018 | Mar. 31, 2018 |
Debt Instrument [Line Items] | |||||||||
Interest expense on borrowings | $ 223,000 | $ 220,000 | $ 676,000 | $ 566,000 | |||||
Accretion of scheduled final payment | 47,000 | 47,000 | 141,000 | 107,000 | |||||
Accretion of deferred debt issuance costs | 16,000 | $ 16,000 | 47,000 | $ 95,000 | |||||
Second Amended and Restated Loan and Security Agreement | |||||||||
Debt Instrument [Line Items] | |||||||||
Long term debt | 10,000,000 | $ 10,000,000 | |||||||
Third Amended and Restated Loan and Security Agreement | |||||||||
Debt Instrument [Line Items] | |||||||||
Debt Instrument, Payment Terms | On October 18, 2019, the Company entered into the 3rd Amendment with the Lenders. Pursuant to the 3rd 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 April 30, 2020, or if the Company completes a specified financial milestone, October 31, 2020, followed by consecutive equal monthly payments of principal and interest in arrears continuing through the maturity date of October 1, 2022. | ||||||||
Third Amended and Restated Loan and Security Agreement | Subsequent Event | |||||||||
Debt Instrument [Line Items] | |||||||||
Long term debt | $ 10,000,000 | ||||||||
Debt instrument, maturity date | Oct. 1, 2022 | ||||||||
Repayment of outstanding amount under the loan agreement including fees | $ 5,000,000 | ||||||||
Debt instrument final payment | 340,441 | ||||||||
Minimum balance requirement cash and cash equivalents | $ 10,000,000 | ||||||||
Silicon Valley Bank, MidCap Funding XII Trust and MidCap Financial Trust | First Amended and Restated Loan and Security Agreement | |||||||||
Debt Instrument [Line Items] | |||||||||
Fixed interest rate | 7.00% | ||||||||
Variable interest rate | 0.50% | ||||||||
Debt instrument, description of variable rate basis | 30-day U.S. LIBOR | ||||||||
Line of credit facility, maximum borrowing capacity | $ 15,000,000 | ||||||||
Long term debt | $ 8,000,000 | ||||||||
Line of credit facility, remaining borrowing capacity | $ 7,000,000 | ||||||||
Line of credit facility, expiration date | Mar. 31, 2018 | ||||||||
Debt Instrument, Payment Terms | The Company was required to pay accrued interest only on the outstanding $8.0 million balance through December 31, 2017, followed by 30 equal payments of principal and accrued interest. | ||||||||
Final payment during maturity | 500,000 | $ 500,000 | |||||||
Debt instrument, maturity date | Jun. 1, 2020 | ||||||||
Repayment of outstanding amount under the loan agreement including fees | $ 5,300,000 | ||||||||
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 | ||||||||
Silicon Valley Bank, MidCap Funding XII Trust and MidCap Financial Trust | First Amended and Restated Loan and Security Agreement | Prepayments Through May 31, 2020 | |||||||||
Debt Instrument [Line Items] | |||||||||
Prepayment fee percentage of the original principal amount of the aggregate term loans | 2.00% | ||||||||
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 | $ 10,000,000 | $ 10,000,000 | ||||||
Debt instrument, maturity date | Oct. 1, 2022 | ||||||||
Final payment during maturity, percentage | 5.50% | ||||||||
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, $5.0 million became available for draw but was not drawn by the Company, and the other $5.0 million is not available for draw. | ||||||||
Silicon Valley Bank, MidCap Funding III Trust and MidCap Financial Trust | Second Amended and Restated Loan and Security Agreement | Prepayment Prior to October 1, 2022 | |||||||||
Debt Instrument [Line Items] | |||||||||
Prepayment fee percentage of the original principal amount | 2.00% | 2.00% | |||||||
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 |
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 | Sep. 30, 2019USD ($) |
Debt Instrument [Line Items] | |
Principal, 2019 | $ 5,000 |
Principal, 2020 | 1,333 |
Principal, 2021 | 2,000 |
Principal, 2022 | 1,667 |
Principal | 10,000 |
Interest and Final Payment, 2019 | 107 |
Interest and Final Payment, 2020 | 392 |
Interest and Final Payment, 2021 | 234 |
Interest and Final Payment, 2022 | 405 |
Interest and Final Payment | 1,138 |
Total, 2019 | 5,107 |
Total, 2020 | 1,725 |
Total, 2021 | 2,234 |
Total, 2022 | 2,072 |
Total | $ 11,138 |
Common Stock - Additional Infor
Common Stock - Additional Information (Details) - $ / shares | Sep. 30, 2019 | Dec. 31, 2018 |
Equity [Abstract] | ||
Common stock, shares authorized | 100,000,000 | 100,000,000 |
Common stock, par value | $ 0.001 | $ 0.001 |
Common stock, shares outstanding | 41,149,781 | 32,119,227 |
Stock Purchase Warrants - Addit
Stock Purchase Warrants - Additional Information (Details) - Convertible Stock Warrant - First Amended and Restated Loan and Security Agreement - $ / shares | 1 Months Ended | 9 Months Ended |
Sep. 30, 2016 | Sep. 30, 2019 | |
Class Of Warrant Or Right [Line Items] | ||
Class of warrant Exercise | $ 10.74 | |
Warrants expiration term | 2026-09 | |
Weighted average remaining life of warrants | 7 years | |
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 | 9 Months Ended | ||
Sep. 30, 2019 | Sep. 30, 2018 | Sep. 30, 2019 | Sep. 30, 2018 | |
Employee Service Share Based Compensation Allocation Of Recognized Period Costs [Line Items] | ||||
Share-based compensation expense | $ 786 | $ 1,282 | $ 3,232 | $ 3,611 |
Research and Development | ||||
Employee Service Share Based Compensation Allocation Of Recognized Period Costs [Line Items] | ||||
Share-based compensation expense | 243 | 491 | 1,066 | 1,365 |
General and Administrative | ||||
Employee Service Share Based Compensation Allocation Of Recognized Period Costs [Line Items] | ||||
Share-based compensation expense | $ 543 | $ 791 | $ 2,166 | $ 2,246 |
Share-Based Compensation - Su_2
Share-Based Compensation - Summary of Activity Related to Stock Options (Details) - Stock Options | 9 Months Ended | |
Sep. 30, 2019$ / sharesshares | Dec. 31, 2018$ / sharesshares | |
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | ||
Number of Shares, Options outstanding, Beginning balance | shares | 3,463,096 | |
Number of Shares, Granted | shares | 1,892,600 | |
Number of Shares, Exercised | shares | (16,362) | |
Number of Shares, Forfeited | shares | (1,146,450) | |
Number of Shares, Options outstanding, Ending balance | shares | 4,192,884 | |
Number of Shares, Options exercisable | shares | 2,204,649 | 1,583,749 |
Weighted Average Exercise Price, Options outstanding, Beginning balance | $ / shares | $ 6.62 | |
Weighted Average Exercise Price, Granted | $ / shares | 1.26 | |
Weighted Average Exercise Price, Exercised | $ / shares | 0.40 | |
Weighted Average Exercise Price, Forfeited | $ / shares | 5 | |
Weighted Average Exercise Price, Options outstanding, Ending balance | $ / shares | 4.67 | |
Weighted Average Exercise Price, Options exercisable | $ / shares | $ 5.61 | $ 5.63 |
Share-Based Compensation - Addi
Share-Based Compensation - Additional Information (Details) - USD ($) | 3 Months Ended | 9 Months Ended | ||
Sep. 30, 2019 | Sep. 30, 2018 | Sep. 30, 2019 | Sep. 30, 2018 | |
2016 Employee Stock Purchase Plan | ||||
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | ||||
Share-based compensation expense | $ 2,000 | $ 4,000 | $ 15,000 | $ 12,000 |
Common stock purchased | 39,539 | |||
Stock Options | ||||
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | ||||
Unrecognized compensation expense related to unvested stock options | 5,000,000 | $ 5,000,000 | ||
Expected to be recognized over a weighted average period | 2 years 4 months 24 days | |||
Restricted Stock Units | ||||
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | ||||
Expected to be recognized over a weighted average period | 1 year 4 months 24 days | |||
Share-based compensation expense | 45,000 | $ 200,000 | ||
Unrecognized compensation expense related to the RSUs | $ 1,000,000 | $ 1,000,000 |
Share-Based Compensation - Su_3
Share-Based Compensation - Summary of the Activity Related to RSUs (Details) - Restricted Stock Units | 9 Months Ended |
Sep. 30, 2019$ / sharesshares | |
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | |
Number of Shares, Granted | shares | 1,339,300 |
Number of Shares, Vested | shares | (20,000) |
Non-vested units outstanding, Number of Shares, Ending balance | shares | 1,319,300 |
Weighted Average Exercise Price, Granted | $ / shares | $ 0.88 |
Weighted Average Exercise Price, Vested | $ / shares | 1.09 |
Non-vested units outstanding, Weighted Average Exercise Price, Ending balance | $ / shares | $ 0.88 |
Commitment and Contingencies -
Commitment and Contingencies - Additional Information (Details) | 1 Months Ended | 3 Months Ended | 9 Months Ended | |||
Aug. 31, 2018USD ($)ft² | Nov. 30, 2016USD ($)ft² | Sep. 30, 2019USD ($) | Sep. 30, 2018USD ($) | Sep. 30, 2019USD ($) | Sep. 30, 2018USD ($) | |
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. | |||||
Weighted average discount rate | 5.30% | 5.30% | ||||
Weighted average lease term | 2 years 4 months 24 days | 2 years 4 months 24 days | ||||
Rent expense | $ 100,000 | $ 79,000 | $ 300,000 | $ 195,000 | ||
Cash payments included in operating activities for operating lease liabilities | $ 386,000 | |||||
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% | |||||
CALIFORNIA | ||||||
Commitment And Contingencies [Line Items] | ||||||
Area of office leased | ft² | 3,500 | |||||
Operating lease agreement term | 2 years | |||||
Operating lease agreement renewal option term | 1 year | |||||
Minimum monthly lease payments | $ 12,775 | |||||
Percentage of increase per year | 3.00% |
Commitment and Contingencies _2
Commitment and Contingencies - Operating Leases Included on the Balance Sheet (Details) $ in Thousands | Sep. 30, 2019USD ($) |
Commitments And Contingencies Disclosure [Abstract] | |
Operating lease right-of-use asset | $ 806 |
Liabilities | |
Current portion of operating lease liabilities | 483 |
Operating lease liabilities | 961 |
Total operating lease liabilities | $ 1,444 |
Commitment and Contingencies _3
Commitment and Contingencies - Total Future Undiscounted Minimum Lease Payments (Details) $ in Thousands | Sep. 30, 2019USD ($) |
Commitments And Contingencies Disclosure [Abstract] | |
2019 | $ 157 |
2020 | 574 |
2021 | 496 |
2022 | 511 |
2023 | 393 |
Total minimum lease payments | $ 2,131 |
Collaboration Agreements - Addi
Collaboration Agreements - Additional Information (Detail) | 3 Months Ended | 9 Months Ended |
Sep. 30, 2019USD ($) | Sep. 30, 2019USD ($) | |
Collaborative Arrangements And Noncollaborative Arrangement Transactions [Line Items] | ||
Revenue | $ 141,000 | $ 231,000 |
Minimum | ||
Collaborative Arrangements And Noncollaborative Arrangement Transactions [Line Items] | ||
Other short-term collaboration agreements performance obligations period | 1 month | |
Maximum | ||
Collaborative Arrangements And Noncollaborative Arrangement Transactions [Line Items] | ||
Other short-term collaboration agreements performance obligations period | 2 months | |
Other Current Liabilities | ||
Collaborative Arrangements And Noncollaborative Arrangement Transactions [Line Items] | ||
Deferred revenue | 400,000 | $ 400,000 |
Collaboration Agreements | ||
Collaborative Arrangements And Noncollaborative Arrangement Transactions [Line Items] | ||
Revenue | $ 141,000 | $ 231,000 |
Fair Value Measurements - Addit
Fair Value Measurements - Additional Information (Details) - USD ($) | 9 Months Ended | |
Sep. 30, 2019 | Dec. 31, 2018 | |
Fair Value Disclosures [Abstract] | ||
Short-term investments maturity start period | 90 days | |
Short-term investments maturity end period | 365 days | |
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 | Sep. 30, 2019 | Dec. 31, 2018 |
Financial Assets: | ||
Total financial assets | $ 22,911 | $ 41,238 |
Cash and Money Markets | ||
Financial Assets: | ||
Total financial assets | 22,551 | 8,042 |
Restricted Cash Money Market | ||
Financial Assets: | ||
Total financial assets | 360 | 360 |
Treasury Bills | ||
Financial Assets: | ||
Total financial assets | 7,490 | |
Commercial Paper | ||
Financial Assets: | ||
Total financial assets | 25,346 | |
Level 1 | ||
Financial Assets: | ||
Total financial assets | 22,911 | 15,892 |
Level 1 | Cash and Money Markets | ||
Financial Assets: | ||
Total financial assets | 22,551 | 8,042 |
Level 1 | Restricted Cash Money Market | ||
Financial Assets: | ||
Total financial assets | $ 360 | 360 |
Level 1 | Treasury Bills | ||
Financial Assets: | ||
Total financial assets | 7,490 | |
Level 2 | ||
Financial Assets: | ||
Total financial assets | 25,346 | |
Level 2 | Commercial Paper | ||
Financial Assets: | ||
Total financial assets | $ 25,346 |
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 | 9 Months Ended | ||
Sep. 30, 2019 | Sep. 30, 2018 | Sep. 30, 2019 | Sep. 30, 2018 | |
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] | ||||
Antidilutive securities excluded from computation of earnings per share | 5,541,980 | 3,250,296 | 5,541,980 | 3,250,296 |
Outstanding Stock Options | ||||
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] | ||||
Antidilutive securities excluded from computation of earnings per share | 4,192,884 | 3,220,500 | 4,192,884 | 3,220,500 |
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 | 1,319,300 | 1,319,300 | ||
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 | 29,796 | 29,796 |
Subsequent Events - Additional
Subsequent Events - Additional Information (Details) - Subsequent Event - USD ($) | Oct. 29, 2019 | Oct. 22, 2019 | Oct. 18, 2019 |
Third Amended and Restated Loan and Security Agreement | |||
Subsequent Event [Line Items] | |||
Repayment of outstanding amount under the loan agreement including fees | $ 5,000,000 | ||
Long term debt | 10,000,000 | ||
Minimum balance requirement cash and cash equivalents | 10,000,000 | ||
Debt instrument final payment | $ 340,441 | ||
Commercial Arrangement | Maximum | |||
Subsequent Event [Line Items] | |||
Pre-launch milestone payments | $ 15,000,000 | ||
Additional milestone payments | 56,000,000 | ||
License Arrangement | REGENXBIO, Inc. | |||
Subsequent Event [Line Items] | |||
Option fee payment | $ 2,000,000 | ||
Proceeds from option fee previously received | 500,000 | ||
Milestone payments | 34,000,000 | ||
Sales-based milestone payments | $ 102,000,000 | ||
Bausch Health Ireland Limited | |||
Subsequent Event [Line Items] | |||
Upfront payment | 5,000,000 | ||
First cumulative net sales of products | $ 30,000,000 |