Document and Entity Information
Document and Entity Information - shares | 9 Months Ended | |
Sep. 30, 2021 | Nov. 05, 2021 | |
Cover [Abstract] | ||
Entity Registrant Name | Clearside Biomedical, Inc. | |
Amendment Flag | false | |
Document Period End Date | Sep. 30, 2021 | |
Document Fiscal Year Focus | 2021 | |
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 | 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 $0.001 per share | |
Security Exchange Name | NASDAQ | |
Entity Incorporation, State or Country Code | DE | |
Document Quarterly Report | true | |
Entity Common Stock, Shares Outstanding | 59,666,519 | |
Entity Shell Company | false | |
Entity Current Reporting Status | Yes | |
Entity File Number | 001-37783 | |
Entity Tax Identification Number | 45-2437375 | |
Entity Address, Address Line One | 900 North Point Parkway | |
Entity Address, Address Line Two | Suite 200 | |
Entity Address, City or Town | Alpharetta | |
Entity Address, State or Province | GA | |
Entity Address, Postal Zip Code | 30005 | |
City Area Code | 678 | |
Local Phone Number | 270-3631 |
Balance Sheets
Balance Sheets - USD ($) $ in Thousands | Sep. 30, 2021 | Dec. 31, 2020 |
Current assets: | ||
Cash and cash equivalents | $ 25,217 | $ 17,287 |
Prepaid expenses | 1,187 | 722 |
Other current assets | 119 | 109 |
Total current assets | 26,523 | 18,118 |
Property and equipment, net | 283 | 416 |
Operating lease right-of-use asset | 412 | 528 |
Restricted cash | 160 | 260 |
Total assets | 27,378 | 19,322 |
Current liabilities: | ||
Accounts payable | 776 | 1,997 |
Accrued liabilities | 2,996 | 1,582 |
Current portion of long-term debt | 991 | |
Current portion of operating lease liabilities | 384 | 373 |
Deferred revenue | 5,000 | 5,000 |
Total current liabilities | 9,156 | 9,943 |
Operating lease liabilities | 374 | 616 |
Total liabilities | 9,530 | 10,559 |
Commitments and contingencies | ||
Stockholders’ equity: | ||
Preferred stock, $0.001 par value; 10,000,000 shares authorized and no shares issued at September 30, 2021 and December 31, 2020 | ||
Common stock, $0.001 par value; 100,000,000 shares authorized at September 30, 2021 and December 31, 2020; 59,626,519 and 51,860,941 shares issued and outstanding at September 30, 2021 and December 31, 2020, respectively | 60 | 52 |
Additional paid-in capital | 291,988 | 264,578 |
Accumulated deficit | (274,200) | (255,867) |
Total stockholders’ equity | 17,848 | 8,763 |
Total liabilities and stockholders’ equity | $ 27,378 | $ 19,322 |
Balance Sheets (Parenthetical)
Balance Sheets (Parenthetical) - $ / shares | Sep. 30, 2021 | Dec. 31, 2020 |
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 | 59,626,519 | 51,860,941 |
Common stock, shares outstanding | 59,626,519 | 51,860,941 |
Statements of Operations
Statements of Operations - USD ($) $ in Thousands | 3 Months Ended | 9 Months Ended | ||
Sep. 30, 2021 | Sep. 30, 2020 | Sep. 30, 2021 | Sep. 30, 2020 | |
Income Statement [Abstract] | ||||
License and other revenue | $ 3,074 | $ 3,432 | $ 3,888 | $ 7,883 |
Type of Revenue [Extensible List] | clsd:LicenseAndOtherRevenueMember | clsd:LicenseAndOtherRevenueMember | clsd:LicenseAndOtherRevenueMember | clsd:LicenseAndOtherRevenueMember |
Operating expenses: | ||||
Research and development | $ 5,147 | $ 3,490 | $ 14,697 | $ 10,601 |
General and administrative | 2,816 | 2,374 | 8,525 | 8,107 |
Total operating expenses | 7,963 | 5,864 | 23,222 | 18,708 |
Loss from operations | (4,889) | (2,432) | (19,334) | (10,825) |
Other income | 2 | 0 | 1,001 | 0 |
Other expense | 0 | (1) | 0 | (273) |
Net loss | $ (4,887) | $ (2,433) | $ (18,333) | $ (11,098) |
Net loss per share of common stock — basic and diluted | $ (0.08) | $ (0.05) | $ (0.32) | $ (0.24) |
Weighted average shares outstanding — basic and diluted | 59,474,346 | 46,976,649 | 58,095,080 | 45,653,068 |
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, 2019 | $ 11,157 | $ 44 | $ 248,770 | $ (237,657) |
Beginning balance, shares at Dec. 31, 2019 | 44,413,372 | |||
Issuance of common shares under at-the-market sales agreement | 1,193 | $ 1 | 1,192 | |
Issuance of common shares under 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 | |||
Beginning balance at Dec. 31, 2019 | 11,157 | $ 44 | 248,770 | (237,657) |
Beginning balance, shares at Dec. 31, 2019 | 44,413,372 | |||
Net loss | (11,098) | |||
Ending balance at Sep. 30, 2020 | 8,124 | $ 48 | 256,831 | (248,755) |
Ending balance, shares at Sep. 30, 2020 | 48,227,442 | |||
Beginning balance at Mar. 31, 2020 | 10,440 | $ 45 | 250,963 | (240,568) |
Beginning balance, shares at Mar. 31, 2020 | 44,868,558 | |||
Issuance of common shares under at-the-market sales agreement | 1,607 | $ 1 | 1,606 | |
Issuance of common shares under at-the-market sales agreement, shares | 800,170 | |||
Exercise of stock options | 72 | 72 | ||
Exercise of stock options, shares | 58,333 | |||
Vesting of restricted stock units, shares | 512,550 | |||
Issuance of common shares under employee stock purchase plan | 31 | 31 | ||
Issuance of common shares under employee stock purchase plan, shares | 35,359 | |||
Share-based compensation expense | 891 | 891 | ||
Net loss | (5,754) | (5,754) | ||
Ending balance at Jun. 30, 2020 | 7,287 | $ 46 | 253,563 | (246,322) |
Ending balance, shares at Jun. 30, 2020 | 46,274,970 | |||
Issuance of common shares under at-the-market sales agreement | 2,285 | $ 2 | 2,283 | |
Issuance of common shares under at-the-market sales agreement, shares | 1,382,564 | |||
Exercise of stock options | 144 | 144 | ||
Exercise of stock options, shares | 194,883 | |||
Vesting of restricted stock units, shares | 375,025 | |||
Share-based compensation expense | 841 | 841 | ||
Net loss | (2,433) | (2,433) | ||
Ending balance at Sep. 30, 2020 | 8,124 | $ 48 | 256,831 | (248,755) |
Ending balance, shares at Sep. 30, 2020 | 48,227,442 | |||
Beginning balance at Dec. 31, 2020 | 8,763 | $ 52 | 264,578 | (255,867) |
Beginning balance, shares at Dec. 31, 2020 | 51,860,941 | |||
Issuance of common shares under a direct registered offering | 11,078 | $ 4 | 11,074 | |
Issuance of common shares under a direct registered offering, shares | 4,209,050 | |||
Issuance of common shares under at-the-market sales agreement | 3,249 | $ 2 | 3,247 | |
Issuance of common shares under at-the-market sales agreement, shares | 1,186,579 | |||
Exercise of stock options | 38 | 38 | ||
Exercise of stock options, shares | 62,493 | |||
Vesting of restricted stock units, shares | 227,754 | |||
Issuance of common shares under employee stock purchase plan | 54 | 54 | ||
Issuance of common shares under employee stock purchase plan, shares | 31,908 | |||
Share-based compensation expense | 1,154 | 1,154 | ||
Net loss | (7,351) | (7,351) | ||
Ending balance at Mar. 31, 2021 | 16,985 | $ 58 | 280,145 | (263,218) |
Ending balance, shares at Mar. 31, 2021 | 57,578,725 | |||
Beginning balance at Dec. 31, 2020 | 8,763 | $ 52 | 264,578 | (255,867) |
Beginning balance, shares at Dec. 31, 2020 | 51,860,941 | |||
Net loss | (18,333) | |||
Ending balance at Sep. 30, 2021 | 17,848 | $ 60 | 291,988 | (274,200) |
Ending balance, shares at Sep. 30, 2021 | 59,626,519 | |||
Beginning balance at Mar. 31, 2021 | 16,985 | $ 58 | 280,145 | (263,218) |
Beginning balance, shares at Mar. 31, 2021 | 57,578,725 | |||
Issuance of common shares under at-the-market sales agreement | 7,084 | $ 1 | 7,083 | |
Issuance of common shares under at-the-market sales agreement, shares | 1,397,436 | |||
Exercise of stock options | 33 | 33 | ||
Exercise of stock options, shares | 21,673 | |||
Vesting of restricted stock units, shares | 93,757 | |||
Share-based compensation expense | 1,331 | 1,331 | ||
Net loss | (6,095) | (6,095) | ||
Ending balance at Jun. 30, 2021 | 19,338 | $ 59 | 288,592 | (269,313) |
Ending balance, shares at Jun. 30, 2021 | 59,091,591 | |||
Issuance of common shares under at-the-market sales agreement | 1,875 | $ 1 | 1,874 | |
Issuance of common shares under at-the-market sales agreement, shares | 307,404 | |||
Exercise of stock options | 149 | 149 | ||
Exercise of stock options, shares | 100,194 | |||
Vesting of restricted stock units, shares | 93,757 | |||
Issuance of common shares under employee stock purchase plan | 57 | 57 | ||
Issuance of common shares under employee stock purchase plan, shares | 33,573 | |||
Share-based compensation expense | 1,316 | 1,316 | ||
Net loss | (4,887) | (4,887) | ||
Ending balance at Sep. 30, 2021 | $ 17,848 | $ 60 | $ 291,988 | $ (274,200) |
Ending balance, shares at Sep. 30, 2021 | 59,626,519 |
Statements of Cash Flows
Statements of Cash Flows - USD ($) $ in Thousands | 9 Months Ended | |
Sep. 30, 2021 | Sep. 30, 2020 | |
Operating activities | ||
Net loss | $ (18,333) | $ (11,098) |
Adjustments to reconcile net loss to net cash used in operating activities: | ||
Depreciation | 133 | 136 |
Share-based compensation expense | 3,801 | 2,733 |
Gain on extinguishment of debt | (998) | |
Non-cash interest expense | 59 | |
Accretion of debt discount | 129 | |
Changes in operating assets and liabilities: | ||
Prepaid expenses and other current assets | (475) | 1,441 |
Other assets and liabilities | (115) | (105) |
Accounts payable and accrued liabilities | (200) | (1,979) |
Net cash used in operating activities | (15,787) | (8,684) |
Investing activities | ||
Acquisition of property and equipment | (55) | |
Net cash provided by (used in) investing activities | (55) | |
Financing activities | ||
Proceeds from registered direct offering, net of issuance costs | 11,078 | |
Proceeds from at-the-market sales agreement, net of issuance costs | 12,208 | 5,084 |
Proceeds from exercise of stock options | 220 | 217 |
Proceeds from shares issued under employee stock purchase plan | 111 | 31 |
Proceeds from long-term debt | 991 | |
Payments made on long-term debt | (5,340) | |
Net cash provided by financing activities | 23,617 | 983 |
Net increase (decrease) in cash, cash equivalents and restricted cash | 7,830 | (7,756) |
Cash, cash equivalents and restricted cash, beginning of period | 17,647 | 22,955 |
Cash, cash equivalents and restricted cash, end of period | 25,477 | 15,199 |
Supplemental disclosure of noncash financing activities | ||
Forgiveness of PPP Loan and accrued interest | 998 | |
Reconciliation of cash, cash equivalents and restricted cash | ||
Cash and cash equivalents | 25,217 | 14,839 |
Restricted cash (including $100 for each period recorded in other current assets) | 260 | 360 |
Cash, cash equivalents and restricted cash at end of period | $ 25,477 | $ 15,199 |
Statements of Cash Flows (Paren
Statements of Cash Flows (Parenthetical) - USD ($) $ in Thousands | Sep. 30, 2021 | Dec. 31, 2020 |
Restricted Cash | $ 260 | |
Other Current Assets [Member] | ||
Restricted Cash | $ 100 | $ 100 |
The Company
The Company | 9 Months Ended |
Sep. 30, 2021 | |
Organization Consolidation And Presentation Of Financial Statements [Abstract] | |
The Company | 1. The Company Clearside Biomedical, Inc. (the “Company”) is a biopharmaceutical company focused on revolutionizing the delivery of therapies to the back of the eye through the suprachoroidal space (SCS ® ). 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's licensees successfully commercialize XIPERE, its other licensees receive regulatory approval and successfully commercializes its product candidates or the Company 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 $ 25.2 million as of September 30, 2021. On January 6, 2021, the Company entered into a securities purchase agreement with certain institutional purchasers that purchased 4.2 million shares of its common stock in a registered direct offering at a price of $ 2.851 per share. The Company raised net proceeds of $ 11.1 million after deducting offering expenses. During the nine months ended September 30, 2021, the Company sold 2.9 million shares of its common stock for net proceeds of $ 12.2 million under its at-the-market agreement with Cowen and Company, LLC. In August 2021, the Company entered into an amendment to the Arctic Vision License Agreement (as defined in Note 10 - License and Other Agreements) to expand the territories covered by the license to include India and the ASEAN Countries (Brunei, Cambodia, Indonesia, Laos, Malaysia, Myanmar, the Philippines, Singapore, Thailand, and Vietnam). In September 2021, the Company entered into a second amendment to the Arctic Vision License Agreement to expand the territories covered by the license to include Australia and New Zealand. The Company received an aggregate of $ 3.0 million in consideration for the expansion of the licensed territory. On October 25, 2021, the Company announced that the U.S. Food and Drug Administration (the "FDA") approved XIPERE (triamcinolone acetonide injectable suspension) for the treatment of macular edema associated with uveitis, a form of eye inflammation. The Company is entitled to an aggregate of $ 9.0 million in milestone payments related to the approval of XIPERE from Arctic Vision (Hong Kong) Limited and Bausch + Lomb. In addition, the Company is entitled to receive $ 10.0 million from Bausch upon completion of pre-launch activities for XIPERE. Bausch expects to launch XIPERE in the United States in the first quarter of 2022. The Company has funded its operations primarily through the sale of common stock and convertible preferred stock and the issuance of long-term debt. The Company will continue to need to obtain additional financing to fund future operations, including completing the development, partnering and potential commercialization of its primary product candidates. The Company will need to obtain financing to conduct additional trials for the regulatory approval of its product candidates if requested by regulatory bodies, and completing the development of any product candidates. If such products were to receive regulatory approval, the Company would need to obtain financing to prepare for the potential commercialization of its product candidates, if the Company decides to commercialize the products on its own. 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 generate significant revenue from its licensees' commercialization of XIPERE. 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. Based on its current plans and forecasted expenses, the Company expects that its cash and cash equivalents as of the filing date, November 10, 2021, will enable it to fund its planned operating expenses and capital expenditure requirements into 2023. This estimate assumes receipt of the $ 9.0 million of milestone payments that the Company is entitled receive from its licensees as a result of the FDA approval of XIPERE. In addition, the estimate assumes receipt of the $ 10.0 million milestone payment that the Company is entitled to receive from Bausch upon completion of pre-launch activities for XIPERE. T he Company has based this estimate on assumptions that may prove to be wrong, and it could exhaust its capital resources sooner than expected. 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. |
Significant Accounting Policies
Significant Accounting Policies | 9 Months Ended |
Sep. 30, 2021 | |
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, 2021, statements of operations for the three and nine months ended September 30, 2021 and 2020, statements of stockholders’ equity for the three and nine months ended September 30, 2021 and 2020 and statements of cash flows for the nine months ended September 30, 2021 and 2020 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, 2021, its results of its operations for the three and nine months ended September 30, 2021 and 2020, its changes in stockholders’ equity for the three and nine months ended September 30, 2021 and 2020 and its cash flows for the nine months ended September 30, 2021 and 2020. The financial data and other information disclosed in these notes related to the three and nine months ended September 30, 2021 and 2020 are unaudited. The results for the nine months ended September 30, 2021 are not indicative of results to be expected for the year ending December 31, 2021, 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, 2020. 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 revenue recognition, the accounting for useful lives to calculate depreciation and amortization, clinical trial expense accruals, share-based compensation expense and income tax valuation allowance. Actual results could differ from these estimates. Effects of COVID-19 The COVID-19 pandemic has created global volatility, economic uncertainty and general market disruption. 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, the Company is not aware of any specific event or circumstance that would require us to update its estimates, assumptions and judgments or revise the carrying value of its 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 (“ASC Topic 606”). The Company’s primary revenue arrangements are license agreements which typically include upfront payments, regulatory and commercial milestone payments and royalties based on future product sales. The arrangements may also include payments for the Company’s SCS Microinjector devices as well as payments for assistance and oversight of the customer’s use of the Company’s technology. In determining the amount of revenue to be recognized under these agreements, the Company performs the following steps: (i) identifies the promised goods and services to be transferred in the contract, (ii) identifies the performance obligations, (iii) determines the transaction price, (iv) allocates the transaction price to the performance obligations and (v) recognizes revenue as the performance obligations are satisfied. 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 preclinical studies and clinical trials; 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 In December 2019, the FASB issued Accounting Standards Update ("ASU") 2019-12, Income Taxes (Topic 740): Simplifying the Accounting for Income Taxes (“ASU 2019-12”), which simplifies the accounting for income taxes by removing certain exceptions related to the approach for intraperiod tax allocation, the methodology for calculating income taxes in an interim period and the recognition of deferred tax liabilities for outside basis differences. The new ASU also simplifies aspects of the accounting for franchise taxes and enacted changes in tax laws or rates. These changes aim to improve the overall usefulness of disclosures to financial statement users and reduce unnecessary costs to companies when preparing the disclosures. The Company adopted ASU 2019-12 on January 1, 2021, 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, 2021 | |
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 September 30, December 31, Furniture and fixtures 5 $ 337 $ 337 Machinery and equipment 5 176 176 Computer equipment 3 13 13 Leasehold improvements Lesser of or 667 667 1,193 1,193 Less: Accumulated depreciation ( 910 ) ( 777 ) $ 283 $ 416 |
Accrued Liabilities
Accrued Liabilities | 9 Months Ended |
Sep. 30, 2021 | |
Payables And Accruals [Abstract] | |
Accrued Liabilities | 4. Accrued Liabilities Accrued liabilities consisted of the following (in thousands): September 30, December 31, 2021 2020 Accrued research and development $ 1,594 $ 234 Accrued employee costs 1,145 1,132 Accrued professional fees 82 56 Accrued expense 175 160 $ 2,996 $ 1,582 |
CARES Act Paycheck Protection P
CARES Act Paycheck Protection Program Loan | 9 Months Ended |
Sep. 30, 2021 | |
Extraordinary And Unusual Items [Abstract] | |
CARES Act Paycheck Protection Program Loan | 5 . CARES Act Paycheck Protection Program Loan On April 20, 2020, the Company entered into a loan agreement with Silicon Valley Bank (the “PPP Lender”) under the terms of which the PPP Lender made a loan to the Company in an aggregate principal amount of $ 1.0 million (the “PPP Loan”) pursuant to the Paycheck Protection Program (the “PPP”) 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 accrued on the outstanding principal amount at the rate of 1.0 % per annum. The term of the Note was until April 2022 , with the Company obligated to make equal monthly payments of principal and interest, beginning in November 2020 and continuing until the maturity date. The CARES Act and the PPP provide a mechanism for forgiveness of up to the full amount borrowed. On January 11, 2021, the Company was notified by the PPP Lender that the PPP Loan had been forgiven in full, including approximately $ 7,000 of accrued interest. In accordance with ASC 405-20, Extinguishment of Liabilities , the income from the forgiveness of the amount borrowed and the accrued interest was recognized in the statement of operations in other income as a gain on extinguishment of debt. |
Common Stock
Common Stock | 9 Months Ended |
Sep. 30, 2021 | |
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, 2021 and December 31, 2020, there were 59,626,519 and 51,860,941 shares of common stock outstanding, respectively. |
Stock Purchase Warrants
Stock Purchase Warrants | 9 Months Ended |
Sep. 30, 2021 | |
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 . The warrants were recorded in equity and had a weighted average remaining life of 5.0 years as of September 30, 2021. |
Share-Based Compensation
Share-Based Compensation | 9 Months Ended |
Sep. 30, 2021 | |
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 Nine Months Ended 2021 2020 2021 2020 Research and development $ 391 $ 290 $ 1,182 $ 882 General and administrative 525 384 1,461 1,176 Total $ 916 $ 674 $ 2,643 $ 2,058 The following table summarizes the activity related to stock options during the nine months ended September 30, 2021: Weighted Number of Average Shares Exercise Price Options outstanding at December 31, 2020 4,248,193 $ 3.95 Granted 1,794,906 3.93 Exercised ( 184,360 ) 1.19 Forfeited — — Options outstanding at September 30, 2021 5,858,739 4.03 Options exercisable at December 31, 2020 2,355,900 4.96 Options exercisable at September 30, 2021 3,081,524 4.58 As of September 30, 2021, the Company had $ 6.5 million of unrecognized compensation expense related to unvested stock options, which is expected to be recognized over a weighted average period of 2.7 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 two 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 total share-based compensation expense related to RSUs is reflected in the statements of operations as follows (in thousands): Three Months Ended Nine Months Ended 2021 2020 2021 2020 Research and development $ 194 $ 70 $ 561 $ 304 General and administrative 190 80 552 348 Total $ 384 $ 150 $ 1,113 $ 652 The following table summarizes the activity related to RSUs during the nine months ended September 30, 2021: Weighted Average Number of Grant Date Shares Fair Value Non-vested RSUs outstanding at December 31, 2020 767,271 $ 1.78 Granted 965,344 4.01 Vested ( 415,268 ) 1.27 Non-vested RSUs outstanding at September 30, 2021 1,317,347 3.58 As of September 30, 2021, the Company had $ 3.8 million of unrecognized compensation expense related to the RSUs which is expected to be recognized over a weighted average period of 3.1 years. Employee Stock Purchase Plan The 2016 Employee Stock Purchase Plan (the “2016 ESPP”) 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 share-based compensation expense recognized for the 2016 ESPP is reflected in the statements of operations and comprehensive loss as follows (in thousands): Three Months Ended Nine Months Ended 2021 2020 2021 2020 Research and development $ 12 $ 10 $ 29 $ 12 General and administrative 4 7 16 11 Total $ 16 $ 17 $ 45 $ 23 During the nine months ended September 30, 2021, the Company issued 65,481 shares of common stock purchased under the 2016 ESPP. |
Commitment and Contingencies
Commitment and Contingencies | 9 Months Ended |
Sep. 30, 2021 | |
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): September 30, Operating lease right-of-use asset $ 412 Liabilities Current portion of operating lease liabilities $ 384 Operating lease liabilities 374 Total operating lease liabilities $ 758 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, 2021, the Company’s weighted average discount rate was 11.0 % and the weighted average lease term was 2.0 years. Minimum lease payments were as follows at September 30, 2021 (in thousands): Year Ending December 31, 2021 $ 99 2022 407 2023 316 Total minimum lease payments 822 Less imputed interest ( 64 ) Total operating lease liabilities $ 758 Equipment leases with an initial term of 12 months or less are not recorded with operating lease liabilities. The Company recognizes expense for these leases on a straight-line basis over the lease term. The equipment leases were deemed to be immaterial. Operating lease cost was $ 62,000 for each of the three months ended September 30, 2021 and 2020, and $ 185,000 for each of the nine months ended September 30, 2021 and 2020. Variable lease cost was $ 24,000 for each of the three months ended September 30, 2021 and 2020, and $ 71,000 for each of the nine months ended September 30, 2021 and 2020. Short-term lease cost was $ 2,000 for each of the three months ended September 30, 2021 and 2020, respectively, and $ 6,000 and $ 10,000 for the nine months ended September 30, 2021 and 2020, respectively. Cash payments included in operating activities on the statement of cash flows for operating lease liabilities were $ 293,000 and $ 283,000 for the nine months ended September 30, 2021 and 2020, 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 | 9 Months Ended |
Sep. 30, 2021 | |
License And Other Agreement [Abstract] | |
License and Other Agreements | 10. License and Other Agreements Bausch + Lomb On October 22, 2019, the Company entered into a License Agreement with Bausch + Lomb, a division of Bausch Health Companies, Inc. (“Bausch”). Pursuant to the Bausch 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 microinjector (the “Device”), as well as specified other steroids, corticosteroids and NSAIDs in combination with the Device (“Other Products,” and together with XIPERE, the “Products”), subject to specified exceptions, in the United States and Canada (the “Territory”) for the treatment of ophthalmology indications, including non-infectious uveitis. On April 27, 2020, the Company and Bausch entered into an 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, Bausch made an upfront payment of $ 5.0 million (the “Upfront Payment”) in October 2019. In October 2021, the FDA approved XIPERE. The Company is entitled to receiv e $ 5.0 million from Bausch as a result of the approval. An additional payment of $ 10.0 million is due upon completion of pre-launch activities for XIPERE. In addition, Bausch has agreed to pay up to an aggregate of $ 55.0 million in additional milestone payments upon the achievement of (i) specified regulatory approvals for specifi ed additional indications of XIPERE 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 Territory, in each case subject to reductions in specified circumstances; provided that the Company will not receive any royalties on the first $ 45.0 million of cumulative net sales of all products in the Territory. Bausch expects to launch XIPERE in the United States in the first quarter of 2022. 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. 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. 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. The Company was responsible for all development expenses for XIPERE in the Territory until the Company's New Drug Application ("NDA") was approved by the FDA, subject to specified exceptions, as well as manufacturing costs in connection with the NDA. The Company was also responsible for all clinical and development expenses conducted to satisfy the FDA’s requests in the complete response letter issued on October 18, 2019 related to the NDA and any subsequent complete response letter related to the NDA (the “CRL-related expenses”). Following FDA approval of XIPERE, Bausch is responsible for all such expenses. Due to the refund provisions in the License Agreement, the upfront payment of $ 5.0 million received from Bausch was included on the balance sheet as deferred revenue as of September 30, 2021 and December 31, 2020. The refund provisions lapsed upon FDA approval of XIPERE. The $ 5.0 million will be recognized as revenue in the fourth quarter of 2021. Arctic Vision (Hong Kong) Limited On March 10, 2020, the Company entered into a License Agreement (the “License Agreement”) with Arctic Vision (Hong Kong) Limited (“Arctic Vision”). Pursuant to the License Agreement, the Company has granted an exclusive license to Arctic Vision to develop, distribute, promote, market and commercialize XIPERE, subject to specified exceptions, in China, Hong Kong, Macau, Taiwan and South Korea (the “Arctic Territory”). Under the terms of the 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 License Agreement, Arctic Vision paid the Company an upfront payment of $ 4.0 million in March 2020. In addition, Arctic Vision has agreed to pay up to $ 31.5 million in development milestone payments for specified events, including $ 4.0 million upon receipt of FDA 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 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. In August 2021, the Company entered into an amendment to the Arctic Vision License Agreement to expand the territories covered by the license to include India and the ASEAN Countries (Brunei, Cambodia, Indonesia, Laos, Malaysia, Myanmar, the Philippines, Singapore, Thailand, and Vietnam). In September 2021, the Company entered into a second amendment to the Arctic Vision License Agreement to expand the Arctic Territory to include Australia and New Zealand. The Company received an aggregate of $ 3.0 million in consideration for the expansion of the Arctic Territory. Other The Company periodically enters into short-term agreements with other customers 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. |
Fair Value Measurements
Fair Value Measurements | 9 Months Ended |
Sep. 30, 2021 | |
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 , on fair value measurements. As defined in the guidance, fair value, defined as an exit price, represents the amount that would be received to sell an asset or pay to transfer a liability in an orderly transaction between market participants. As a result, fair value is a market-based approach that should be determined based on assumptions that market participants would use in pricing an asset or a liability. As a basis for considering these assumptions, the guidance defines a three-tier value hierarchy that prioritizes the inputs used in the valuation methodologies in measuring fair value. 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, 2021 and December 31, 2020 consisted primarily of cash and cash equivalents, and at December 31, 2020, also included 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 nine months ended September 30, 2021 and the year ended December 31, 2020. |
Net Loss per Share
Net Loss per Share | 9 Months Ended |
Sep. 30, 2021 | |
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, restricted stock units 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 Nine Months Ended 2021 2020 2021 2020 Outstanding stock options 5,858,739 4,249,443 5,858,739 4,249,443 Non-vested restricted stock units 1,317,347 861,025 1,317,347 861,025 Stock purchase warrants 29,796 29,796 29,796 29,796 7,205,882 5,140,264 7,205,882 5,140,264 |
Significant Accounting Polici_2
Significant Accounting Policies (Policies) | 9 Months Ended |
Sep. 30, 2021 | |
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, 2021, statements of operations for the three and nine months ended September 30, 2021 and 2020, statements of stockholders’ equity for the three and nine months ended September 30, 2021 and 2020 and statements of cash flows for the nine months ended September 30, 2021 and 2020 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, 2021, its results of its operations for the three and nine months ended September 30, 2021 and 2020, its changes in stockholders’ equity for the three and nine months ended September 30, 2021 and 2020 and its cash flows for the nine months ended September 30, 2021 and 2020. The financial data and other information disclosed in these notes related to the three and nine months ended September 30, 2021 and 2020 are unaudited. The results for the nine months ended September 30, 2021 are not indicative of results to be expected for the year ending December 31, 2021, 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, 2020. |
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 revenue recognition, the accounting for useful lives to calculate depreciation and amortization, clinical trial expense accruals, share-based compensation expense and income tax valuation allowance. Actual results could differ from these estimates. |
Effects of COVID-19 | Effects of COVID-19 The COVID-19 pandemic has created global volatility, economic uncertainty and general market disruption. 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, the Company is not aware of any specific event or circumstance that would require us to update its estimates, assumptions and judgments or revise the carrying value of its 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 (“ASC Topic 606”). The Company’s primary revenue arrangements are license agreements which typically include upfront payments, regulatory and commercial milestone payments and royalties based on future product sales. The arrangements may also include payments for the Company’s SCS Microinjector devices as well as payments for assistance and oversight of the customer’s use of the Company’s technology. In determining the amount of revenue to be recognized under these agreements, the Company performs the following steps: (i) identifies the promised goods and services to be transferred in the contract, (ii) identifies the performance obligations, (iii) determines the transaction price, (iv) allocates the transaction price to the performance obligations and (v) recognizes revenue as the performance obligations are satisfied. 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 preclinical studies and clinical trials; 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 In December 2019, the FASB issued Accounting Standards Update ("ASU") 2019-12, Income Taxes (Topic 740): Simplifying the Accounting for Income Taxes (“ASU 2019-12”), which simplifies the accounting for income taxes by removing certain exceptions related to the approach for intraperiod tax allocation, the methodology for calculating income taxes in an interim period and the recognition of deferred tax liabilities for outside basis differences. The new ASU also simplifies aspects of the accounting for franchise taxes and enacted changes in tax laws or rates. These changes aim to improve the overall usefulness of disclosures to financial statement users and reduce unnecessary costs to companies when preparing the disclosures. The Company adopted ASU 2019-12 on January 1, 2021, 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, 2021 | |
Property Plant And Equipment [Abstract] | |
Schedule of Property and Equipment, Net | Property and equipment, net consisted of the following (dollar amounts in thousands): Estimated September 30, December 31, Furniture and fixtures 5 $ 337 $ 337 Machinery and equipment 5 176 176 Computer equipment 3 13 13 Leasehold improvements Lesser of or 667 667 1,193 1,193 Less: Accumulated depreciation ( 910 ) ( 777 ) $ 283 $ 416 |
Accrued Liabilities (Tables)
Accrued Liabilities (Tables) | 9 Months Ended |
Sep. 30, 2021 | |
Payables And Accruals [Abstract] | |
Schedule of Accrued Liabilities | Accrued liabilities consisted of the following (in thousands): September 30, December 31, 2021 2020 Accrued research and development $ 1,594 $ 234 Accrued employee costs 1,145 1,132 Accrued professional fees 82 56 Accrued expense 175 160 $ 2,996 $ 1,582 |
Share-Based Compensation (Table
Share-Based Compensation (Tables) | 9 Months Ended |
Sep. 30, 2021 | |
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 Nine Months Ended 2021 2020 2021 2020 Research and development $ 391 $ 290 $ 1,182 $ 882 General and administrative 525 384 1,461 1,176 Total $ 916 $ 674 $ 2,643 $ 2,058 |
Summary of Activity Related to Stock Options | The following table summarizes the activity related to stock options during the nine months ended September 30, 2021: Weighted Number of Average Shares Exercise Price Options outstanding at December 31, 2020 4,248,193 $ 3.95 Granted 1,794,906 3.93 Exercised ( 184,360 ) 1.19 Forfeited — — Options outstanding at September 30, 2021 5,858,739 4.03 Options exercisable at December 31, 2020 2,355,900 4.96 Options exercisable at September 30, 2021 3,081,524 4.58 |
Restricted Stock Units (RSUs) | |
Summary of Share-based Compensation Expense | The total share-based compensation expense related to RSUs is reflected in the statements of operations as follows (in thousands): Three Months Ended Nine Months Ended 2021 2020 2021 2020 Research and development $ 194 $ 70 $ 561 $ 304 General and administrative 190 80 552 348 Total $ 384 $ 150 $ 1,113 $ 652 |
Summary of the Activity Related to RSUs | The following table summarizes the activity related to RSUs during the nine months ended September 30, 2021: Weighted Average Number of Grant Date Shares Fair Value Non-vested RSUs outstanding at December 31, 2020 767,271 $ 1.78 Granted 965,344 4.01 Vested ( 415,268 ) 1.27 Non-vested RSUs outstanding at September 30, 2021 1,317,347 3.58 |
2016 Employee Stock Purchase Plan | |
Summary of Share-based Compensation Expense | The share-based compensation expense recognized for the 2016 ESPP is reflected in the statements of operations and comprehensive loss as follows (in thousands): Three Months Ended Nine Months Ended 2021 2020 2021 2020 Research and development $ 12 $ 10 $ 29 $ 12 General and administrative 4 7 16 11 Total $ 16 $ 17 $ 45 $ 23 |
Commitment and Contingencies (T
Commitment and Contingencies (Tables) | 9 Months Ended |
Sep. 30, 2021 | |
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, Operating lease right-of-use asset $ 412 Liabilities Current portion of operating lease liabilities $ 384 Operating lease liabilities 374 Total operating lease liabilities $ 758 |
Future Minimum Commitments Due Under Non-Cancelable Operating Leases | Minimum lease payments were as follows at September 30, 2021 (in thousands): Year Ending December 31, 2021 $ 99 2022 407 2023 316 Total minimum lease payments 822 Less imputed interest ( 64 ) Total operating lease liabilities $ 758 |
Net Loss per Share (Tables)
Net Loss per Share (Tables) | 9 Months Ended |
Sep. 30, 2021 | |
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 Nine Months Ended 2021 2020 2021 2020 Outstanding stock options 5,858,739 4,249,443 5,858,739 4,249,443 Non-vested restricted stock units 1,317,347 861,025 1,317,347 861,025 Stock purchase warrants 29,796 29,796 29,796 29,796 7,205,882 5,140,264 7,205,882 5,140,264 |
The Company - Additional Inform
The Company - Additional Information (Details) - USD ($) $ / shares in Units, $ in Thousands, shares in Millions | Oct. 25, 2021 | Jan. 06, 2021 | Sep. 30, 2021 | Dec. 31, 2020 | Sep. 30, 2020 |
Class of Stock [Line Items] | |||||
Entity incorporation date | May 26, 2011 | ||||
Cash and cash equivalents | $ 25,217 | $ 17,287 | $ 14,839 | ||
Net proceeds after deducting offering expenses | (11,078) | ||||
Aggregate milestone payments from the licensees | $ 9,000 | 9,000 | |||
Pre-launch milestone payments | 10,000 | ||||
Arctic Vision Limited | License Arrangement | |||||
Class of Stock [Line Items] | |||||
Consideration received from expansion of business | $ 3,000 | ||||
Bausch Health Ireland Limited | |||||
Class of Stock [Line Items] | |||||
Aggregate milestone payments from the licensees | $ 10,000 | ||||
Private Placement | Common Stock | |||||
Class of Stock [Line Items] | |||||
Purchase of common stock by institutional purchasers | 4.2 | ||||
Purchase price per share | $ 2.851 | ||||
Net proceeds after deducting offering expenses | $ 11,100 | ||||
At-the-market Sales Agreement | Cowen and Company LLC | Common Stock | |||||
Class of Stock [Line Items] | |||||
Number of shares sold under facility | 2.9 | ||||
Net proceeds from issuance of stock | $ 12,200 |
Property and Equipment, Net - S
Property and Equipment, Net - Schedule of Property and Equipment, Net (Details) - USD ($) $ in Thousands | 9 Months Ended | |
Sep. 30, 2021 | Dec. 31, 2020 | |
Property Plant And Equipment [Line Items] | ||
Property and Equipment, gross | $ 1,193 | $ 1,193 |
Less: Accumulated depreciation | (910) | (777) |
Property and equipment, net | 283 | 416 |
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 | 176 |
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 ofuseful life orremaininglease term |
Accrued Liabilities - Schedule
Accrued Liabilities - Schedule of Accrued Liabilities (Details) - USD ($) $ in Thousands | Sep. 30, 2021 | Dec. 31, 2020 |
Payables And Accruals [Abstract] | ||
Accrued research and development | $ 1,594 | $ 234 |
Accrued employee costs | 1,145 | 1,132 |
Accrued professional fees | 82 | 56 |
Accrued expense | 175 | 160 |
Accrued liabilities, current | $ 2,996 | $ 1,582 |
CARES Act Paycheck Protection_2
CARES Act Paycheck Protection Program Loan - Additional Information (Details) - PPP Loan - USD ($) $ in Thousands | Jan. 11, 2021 | Apr. 20, 2020 |
Interest Expense | ||
Short Term Debt [Line Items] | ||
Interest expense on borrowings | $ 7,000 | |
Silicon Valley Bank | ||
Short Term Debt [Line Items] | ||
Aggregate principal amount | $ 1,000 | |
Interest rate on outstanding principal amount | 1.00% | |
Note, Maturity date | Apr. 30, 2022 |
Common Stock - Additional Infor
Common Stock - Additional Information (Details) - $ / shares | Sep. 30, 2021 | Dec. 31, 2020 |
Equity [Abstract] | ||
Common stock, shares authorized | 100,000,000 | 100,000,000 |
Common stock, par value | $ 0.001 | $ 0.001 |
Common stock, shares outstanding | 59,626,519 | 51,860,941 |
Stock Purchase Warrants - Addit
Stock Purchase Warrants - Additional Information (Details) - $ / shares | 1 Months Ended | 9 Months Ended |
Sep. 30, 2016 | Sep. 30, 2021 | |
Maximum | ||
Class Of Warrant Or Right [Line Items] | ||
Number of stock that can be purchased by each warrant | 29,796 | |
Convertible Stock Warrant | ||
Class Of Warrant Or Right [Line Items] | ||
Class of warrant Exercise | $ 10.74 | |
Warrants expiration term | 2026-09 | |
Weighted average remaining life of warrants | 5 years |
Share-Based Compensation - Summ
Share-Based Compensation - Summary of Share-based Compensation Expense (Details) - USD ($) $ in Thousands | 3 Months Ended | 9 Months Ended | ||
Sep. 30, 2021 | Sep. 30, 2020 | Sep. 30, 2021 | Sep. 30, 2020 | |
2016 Employee Stock Purchase Plan | ||||
Employee Service Share Based Compensation Allocation Of Recognized Period Costs [Line Items] | ||||
Share-based compensation expense | $ 16 | $ 17 | $ 45 | $ 23 |
2016 Employee Stock Purchase Plan | Research and Development | ||||
Employee Service Share Based Compensation Allocation Of Recognized Period Costs [Line Items] | ||||
Share-based compensation expense | 12 | 10 | 29 | 12 |
2016 Employee Stock Purchase Plan | General and Administrative | ||||
Employee Service Share Based Compensation Allocation Of Recognized Period Costs [Line Items] | ||||
Share-based compensation expense | 4 | 7 | 16 | 11 |
Stock Options | 2011 Stock Incentive Plan, 2016 Equity Incentive Plan | ||||
Employee Service Share Based Compensation Allocation Of Recognized Period Costs [Line Items] | ||||
Share-based compensation expense | 916 | 674 | 2,643 | 2,058 |
Stock Options | 2011 Stock Incentive Plan, 2016 Equity Incentive Plan | Research and Development | ||||
Employee Service Share Based Compensation Allocation Of Recognized Period Costs [Line Items] | ||||
Share-based compensation expense | 391 | 290 | 1,182 | 882 |
Stock Options | 2011 Stock Incentive Plan, 2016 Equity Incentive Plan | General and Administrative | ||||
Employee Service Share Based Compensation Allocation Of Recognized Period Costs [Line Items] | ||||
Share-based compensation expense | 525 | 384 | 1,461 | 1,176 |
Restricted Stock Units (RSUs) | ||||
Employee Service Share Based Compensation Allocation Of Recognized Period Costs [Line Items] | ||||
Share-based compensation expense | 384 | 150 | 1,113 | 652 |
Restricted Stock Units (RSUs) | Research and Development | ||||
Employee Service Share Based Compensation Allocation Of Recognized Period Costs [Line Items] | ||||
Share-based compensation expense | 194 | 70 | 561 | 304 |
Restricted Stock Units (RSUs) | General and Administrative | ||||
Employee Service Share Based Compensation Allocation Of Recognized Period Costs [Line Items] | ||||
Share-based compensation expense | $ 190 | $ 80 | $ 552 | $ 348 |
Share-Based Compensation - Su_2
Share-Based Compensation - Summary of Activity Related to Stock Options (Details) - Stock Options | 9 Months Ended | |
Sep. 30, 2021$ / sharesshares | Dec. 31, 2020$ / sharesshares | |
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | ||
Number of Shares, Options outstanding, Beginning balance | shares | 4,248,193 | |
Number of Shares, Granted | shares | 1,794,906 | |
Number of Shares, Exercised | shares | (184,360) | |
Number of Shares, Forfeited | shares | ||
Number of Shares, Options outstanding, Ending balance | shares | 5,858,739 | |
Number of Shares, Options exercisable | shares | 3,081,524 | 2,355,900 |
Weighted Average Exercise Price, Options outstanding, Beginning balance | $ / shares | $ 3.95 | |
Weighted Average Exercise Price, Granted | $ / shares | 3.93 | |
Weighted Average Exercise Price, Exercised | $ / shares | 1.19 | |
Weighted Average Exercise Price, Forfeited | $ / shares | ||
Weighted Average Exercise Price, Options outstanding, Ending balance | $ / shares | 4.03 | |
Weighted Average Exercise Price, Options exercisable | $ / shares | $ 4.58 | $ 4.96 |
Share-Based Compensation - Addi
Share-Based Compensation - Additional Information (Details) $ in Millions | 9 Months Ended |
Sep. 30, 2021USD ($)shares | |
2016 Employee Stock Purchase Plan | |
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | |
Issuance of common shares under employee stock purchase plan, shares | shares | 65,481 |
Stock Options | |
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | |
Unrecognized compensation expense related to unvested stock options | $ 6.5 |
Expected to be recognized over a weighted average period | 2 years 8 months 12 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 | 3 years 1 month 6 days |
Unrecognized compensation expense related to the RSUs | $ 3.8 |
Share-Based Compensation - Su_3
Share-Based Compensation - Summary of the Activity Related to RSUs (Details) - Restricted Stock Units (RSUs) | 9 Months Ended |
Sep. 30, 2021$ / sharesshares | |
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | |
Non-vested units outstanding, Number of Shares, Beginning balance | shares | 767,271 |
Number of Shares, Granted | shares | 965,344 |
Number of Shares, Vested | shares | (415,268) |
Non-vested units outstanding, Number of Shares, Ending balance | shares | 1,317,347 |
Non-vested units outstanding, Weighted Average Exercise Price, Beginning balance | $ / shares | $ 1.78 |
Weighted Average Exercise Price, Granted | $ / shares | 4.01 |
Weighted Average Exercise Price, Vested | $ / shares | 1.27 |
Non-vested units outstanding, Weighted Average Exercise Price, Ending balance | $ / shares | $ 3.58 |
Commitment and Contingencies -
Commitment and Contingencies - Additional Information (Details) | 1 Months Ended | 3 Months Ended | 9 Months Ended | ||
Nov. 30, 2016USD ($)ft² | Sep. 30, 2021USD ($) | Sep. 30, 2020USD ($) | Sep. 30, 2021USD ($) | Sep. 30, 2020USD ($) | |
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% | 11.00% | |||
Operating lease, remaining lease term | 2 years | 2 years | |||
Operating Lease, Cost | $ 62,000 | $ 62,000 | $ 185,000 | $ 185,000 | |
Variable Lease, Cost | 24,000 | 24,000 | 71,000 | 71,000 | |
Short-term Lease, Cost | $ 2,000 | $ 2,000 | 6,000 | 10,000 | |
Cash payments included in operating activities for operating lease liabilities | $ 293,000 | $ 283,000 | |||
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 | Sep. 30, 2021 | Dec. 31, 2020 |
Commitments And Contingencies Disclosure [Abstract] | ||
Operating lease right-of-use asset | $ 412 | $ 528 |
Liabilities | ||
Current portion of operating lease liabilities | 384 | 373 |
Operating lease liabilities | 374 | $ 616 |
Total operating lease liabilities | $ 758 |
Commitment and Contingencies _3
Commitment and Contingencies - Future Minimum Commitments Due Under Non-Cancelable Operating Leases (Details) $ in Thousands | Sep. 30, 2021USD ($) |
Commitments And Contingencies Disclosure [Abstract] | |
2021 | $ 99 |
2022 | 407 |
2023 | 316 |
Total minimum lease payments | 822 |
Less imputed interest | (64) |
Total operating lease liabilities | $ 758 |
License and Other Agreements -
License and Other Agreements - Additional Information (Detail) - USD ($) $ in Thousands | Mar. 10, 2020 | Oct. 22, 2019 | Oct. 31, 2021 | Dec. 31, 2021 | Sep. 30, 2021 | Sep. 30, 2020 | Sep. 30, 2021 | Sep. 30, 2020 | Dec. 31, 2020 |
Research And Development Arrangement Contract To Perform For Others [Line Items] | |||||||||
Pre-launch milestone payments | $ 10,000 | ||||||||
Deferred revenue | $ 5,000 | 5,000 | $ 5,000 | ||||||
License and other revenue | 3,074 | $ 3,432 | 3,888 | $ 7,883 | |||||
Bausch Health Ireland Limited | |||||||||
Research And Development Arrangement Contract To Perform For Others [Line Items] | |||||||||
Upfront payment | $ 5,000 | ||||||||
First cumulative net sales of products | $ 45,000 | ||||||||
Bausch Health Ireland Limited | Upfront Payment | |||||||||
Research And Development Arrangement Contract To Perform For Others [Line Items] | |||||||||
Upfront payment | $ 4,000 | ||||||||
Deferred revenue | 5,000 | 5,000 | $ 5,000 | ||||||
Milestone Payments Received | 5,000 | ||||||||
Bausch Health Ireland Limited | Forecast | Upfront Payment | |||||||||
Research And Development Arrangement Contract To Perform For Others [Line Items] | |||||||||
License and other revenue | $ 5,000 | ||||||||
Arctic Vision Limited | Maximum | |||||||||
Research And Development Arrangement Contract To Perform For Others [Line Items] | |||||||||
Development milestone payments | $ 31,500 | ||||||||
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% | ||||||||
XIPERE [Member] | Arctic Vision Limited | Maximum | |||||||||
Research And Development Arrangement Contract To Perform For Others [Line Items] | |||||||||
Development milestone payments | $ 4,000 | ||||||||
Commercial Arrangement | Bausch Health Ireland Limited | |||||||||
Research And Development Arrangement Contract To Perform For Others [Line Items] | |||||||||
Pre-launch milestone payments | 10,000 | ||||||||
Commercial Arrangement | Bausch Health Ireland Limited | Maximum | |||||||||
Research And Development Arrangement Contract To Perform For Others [Line Items] | |||||||||
Additional milestone payments | $ 55,000 | ||||||||
License Arrangement | Arctic Vision Limited | |||||||||
Research And Development Arrangement Contract To Perform For Others [Line Items] | |||||||||
Additional fees for expansion to existing license | $ 3,000 | $ 3,000 |
Fair Value Measurements - Addit
Fair Value Measurements - Additional Information (Details) - USD ($) | Sep. 30, 2021 | Dec. 31, 2020 |
Fair Value Disclosures [Abstract] | ||
Significant transfers between Levels 1, 2 and 3 | $ 0 | $ 0 |
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, 2021 | Sep. 30, 2020 | Sep. 30, 2021 | Sep. 30, 2020 | |
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] | ||||
Antidilutive securities excluded from computation of earnings per share | 7,205,882 | 5,140,264 | 7,205,882 | 5,140,264 |
Outstanding Stock Options | ||||
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] | ||||
Antidilutive securities excluded from computation of earnings per share | 5,858,739 | 4,249,443 | 5,858,739 | 4,249,443 |
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 | 1,317,347 | 861,025 | 1,317,347 | 861,025 |
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 |