Document and Entity Information
Document and Entity Information - USD ($) | 12 Months Ended | ||
Dec. 31, 2022 | Mar. 08, 2023 | Jun. 30, 2022 | |
Cover [Abstract] | |||
Entity Registrant Name | Clearside Biomedical, Inc. | ||
Amendment Flag | false | ||
Document Period End Date | Dec. 31, 2022 | ||
Document Fiscal Year Focus | 2022 | ||
Document Fiscal Period Focus | FY | ||
Trading Symbol | CLSD | ||
Document Type | 10-K | ||
Entity Central Index Key | 0001539029 | ||
Current Fiscal Year End Date | --12-31 | ||
Entity Well-known Seasoned Issuer | No | ||
Entity Current Reporting Status | Yes | ||
Entity Voluntary Filers | No | ||
Entity Filer Category | Non-accelerated Filer | ||
Entity Small Business | true | ||
Entity Emerging Growth Company | false | ||
Entity Shell Company | false | ||
Entity Common Stock, Shares Outstanding | 61,364,299 | ||
Entity Public Float | $ 80,000,000 | ||
Entity Interactive Data Current | Yes | ||
Title of 12(b) Security | Common Stock, par value $0.001 per share | ||
Security Exchange Name | NASDAQ | ||
Entity File Number | 001-37783 | ||
Entity Incorporation, State or Country Code | DE | ||
Entity Tax Identification Number | 45-2437375 | ||
Entity Address, Address Line One | 900 North Point Parkway | ||
Entity Address, Address Line Two | Suite 200 | ||
Entity Address, City or Town | Alpharetta | ||
Entity Address, State or Province | GA | ||
Entity Address, Postal Zip Code | 30005 | ||
City Area Code | 678 | ||
Local Phone Number | 270-3631 | ||
Document Annual Report | true | ||
Document Transition Report | false | ||
Documents Incorporated by Reference | Portions of the Company’s definitive proxy statement, to be filed pursuant to Regulation 14A under the Securities Exchange Act of 1934, for its 2023 Annual Meeting of Stockholders are incorporated by reference in Part III of the Form 10-K. | ||
Auditor Name | Ernst & Young LLP | ||
Auditor Location | Atlanta, Georgia | ||
Auditor Firm ID | 42 |
Balance Sheets
Balance Sheets - USD ($) $ in Thousands | Dec. 31, 2022 | Dec. 31, 2021 |
Current assets: | ||
Cash and cash equivalents | $ 48,258 | $ 30,436 |
Accounts receivable | 0 | 10,000 |
Prepaid expenses | 704 | 921 |
Other current assets | 439 | 779 |
Total current assets | 49,401 | 42,136 |
Property and equipment, net | 755 | 238 |
Operating lease right-of-use asset | 1,117 | 369 |
Restricted cash and other assets | 30 | 160 |
Total assets | 51,303 | 42,903 |
Current liabilities: | ||
Accounts payable | 1,050 | 941 |
Accrued liabilities | 4,179 | 3,312 |
Current portion of operating lease liabilities | 349 | 387 |
Deferred revenue | 205 | 0 |
Total current liabilities | 5,783 | 4,640 |
Liability related to the sales of future royalties, net | 33,977 | 0 |
Operating lease liabilities | 936 | 288 |
Total liabilities | 40,696 | 4,928 |
Commitments and contingencies | ||
Stockholders’ equity: | ||
Preferred stock, $0.001 par value; 10,000,000 shares authorized and no shares issued at December 31, 2022 and 2021 | 0 | 0 |
Common stock, $0.001 par value; 200,000,000 and 100,000,000 shares authorized at December 31, 2022 and 2021, respectively; 60,639,827 and 59,722,930 shares issued and outstanding at December 31, 2022 and 2021, respectively | 61 | 60 |
Additional paid-in capital | 298,984 | 293,406 |
Accumulated deficit | (288,438) | (255,491) |
Total stockholders’ equity | 10,607 | 37,975 |
Total liabilities and stockholders’ equity | $ 51,303 | $ 42,903 |
Balance Sheets (Parenthetical)
Balance Sheets (Parenthetical) - $ / shares | Dec. 31, 2022 | Dec. 31, 2021 |
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 | 200,000,000 | 100,000,000 |
Common stock, shares, issued | 60,639,827 | 59,722,930 |
Common stock, shares outstanding | 60,639,827 | 59,722,930 |
Statements of Operations
Statements of Operations - USD ($) $ in Thousands | 12 Months Ended | ||
Dec. 31, 2022 | Dec. 31, 2021 | Dec. 31, 2020 | |
Income Statement [Abstract] | |||
License and other revenue | $ 1,327 | $ 29,575 | $ 7,894 |
Type of Revenue [Extensible List] | License [Member] | License [Member] | License [Member] |
Operating expenses: | |||
Cost of goods sold | $ 204 | $ 0 | $ 0 |
Research and development | 19,630 | 18,537 | 15,073 |
General and administrative | 11,770 | 11,665 | 10,756 |
Total operating expenses | 31,604 | 30,202 | 25,829 |
Loss from operations | (30,277) | (627) | (17,935) |
Other income | 669 | 1,003 | 0 |
Non-cash interest expense on liability related to the sales of future royalties | (3,339) | 0 | 0 |
Other expense | 0 | 0 | (275) |
Net (loss) income | $ (32,947) | $ 376 | $ (18,210) |
Net (loss) income per share of common stock - basic | $ (0.55) | $ 0.01 | $ (0.39) |
Net (loss) income per share of common stock - diluted | $ (0.55) | $ 0.01 | $ (0.39) |
Weighted average shares outstanding - basic | 60,204,862 | 58,491,986 | 46,506,540 |
Weighted average shares outstanding - diluted | 60,204,862 | 59,906,602 | 46,506,540 |
Statement of Stockholders' Equi
Statement of Stockholders' Equity (Deflicit) - 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 | 11,958 | $ 6 | 11,952 | |
Issuance of common shares under at-the-market sales agreement, shares | 6,176,415 | |||
Issuance of common shares under employee stock purchase plan | 31 | 31 | ||
Issuance of common shares under employee stock purchase plan, shares | 35,359 | |||
Exercise of stock options | 227 | $ 2 | 225 | |
Exercise of stock options, shares | 254,466 | |||
Vesting and settlement of restricted stock units, shares | 981,329 | |||
Share-based compensation expense | 3,600 | 3,600 | ||
Net income (loss) | (18,210) | (18,210) | ||
Ending balance at Dec. 31, 2020 | 8,763 | $ 52 | 264,578 | (255,867) |
Ending balance, shares at Dec. 31, 2020 | 51,860,941 | |||
Issuance of common shares under at-the-market sales agreement | 12,205 | $ 3 | 12,202 | |
Issuance of common shares under at-the-market sales agreement, shares | 2,891,419 | |||
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 employee stock purchase plan | 111 | 111 | ||
Issuance of common shares under employee stock purchase plan, shares | 65,481 | |||
Exercise of stock options | 388 | $ 1 | 387 | |
Exercise of stock options, shares | 280,771 | |||
Vesting and settlement of restricted stock units, shares | 415,268 | |||
Share-based compensation expense | 5,054 | 5,054 | ||
Net income (loss) | 376 | 376 | ||
Ending balance at Dec. 31, 2021 | 37,975 | $ 60 | 293,406 | (255,491) |
Ending balance, shares at Dec. 31, 2021 | 59,722,930 | |||
Issuance of common shares under at-the-market sales agreement | 566 | $ 1 | 565 | |
Issuance of common shares under at-the-market sales agreement, shares | 425,460 | |||
Issuance of common shares under employee stock purchase plan | 112 | 112 | ||
Issuance of common shares under employee stock purchase plan, shares | 66,919 | |||
Exercise of stock options | 17 | $ 0 | 17 | |
Exercise of stock options, shares | 49,187 | |||
Vesting and settlement of restricted stock units, shares | 375,331 | |||
Share-based compensation expense | 4,884 | 4,884 | ||
Net income (loss) | (32,947) | (32,947) | ||
Ending balance at Dec. 31, 2022 | $ 10,607 | $ 61 | $ 298,984 | $ (288,438) |
Ending balance, shares at Dec. 31, 2022 | 60,639,827 |
Statements of Cash Flows
Statements of Cash Flows - USD ($) $ in Thousands | 12 Months Ended | ||
Dec. 31, 2022 | Dec. 31, 2021 | Dec. 31, 2020 | |
Operating activities | |||
Net (loss) income | $ (32,947) | $ 376 | $ (18,210) |
Adjustments to reconcile net (loss) income to net cash used inoperating activities: | |||
Non-cash interest expense on liability related to the sales of future royalties | 3,339 | 0 | 0 |
Depreciation | 145 | 178 | 180 |
Share-based compensation expense | 4,884 | 5,054 | 3,600 |
Gain on termination of operating lease | (55) | 0 | 0 |
Loss on disposal of fixed assets | 33 | 0 | 0 |
Gain on extinguishment of debt | 0 | (998) | 0 |
Non-cash interest expense | 0 | 0 | 59 |
Accretion of debt discount | 0 | 0 | 129 |
Changes in operating assets and liabilities: | |||
Accounts receivable, prepaid expenses and other current assets | 10,420 | (10,869) | 1,893 |
Other assets and liabilities | (83) | (155) | (140) |
Accounts payable and accrued liabilities | 694 | 681 | (631) |
Deferred revenue | 205 | (5,000) | 0 |
Net cash used in operating activities | (13,365) | (10,733) | (13,120) |
Investing activities | |||
Acquisition of property and equipment | (246) | 0 | (55) |
Net cash used in investing activities | (246) | 0 | (55) |
Financing activities | |||
Proceeds from royalty purchase and sale agreement, net of issuance costs | 30,638 | 0 | 0 |
Proceeds from at-the-market sales agreement, net of issuance costs | 566 | 12,205 | 11,958 |
Proceeds from registered direct offering, net of issuance costs | 0 | 11,078 | 0 |
Proceeds from shares issued under employee stock purchase plan | 112 | 111 | 31 |
Proceeds from exercise of stock options | 17 | 388 | 227 |
Proceeds from issuance of long-term debt | 0 | 0 | 991 |
Principal payments made on long-term debt | 0 | 0 | (5,340) |
Net cash provided by financing activities | 31,333 | 23,782 | 7,867 |
Net increase (decrease) in cash, cash equivalents and restricted cash | 17,722 | 13,049 | (5,308) |
Cash, cash equivalents and restricted cash, beginning of period | 30,696 | 17,647 | 22,955 |
Cash, cash equivalents and restricted cash, end of period | 48,418 | 30,696 | 17,647 |
Supplemental disclosure | |||
Interest paid | 0 | 0 | 524 |
Purchase of property and equipment in accounts payable and accrued liabilities | 282 | 0 | 0 |
Forgiveness of PPP Loan and accrued interest | 0 | 998 | 0 |
Reconciliation of cash, cash equivalents and restricted cash: | |||
Cash and cash equivalents | 48,258 | 30,436 | 17,287 |
Restricted cash ($160 and $100 as of December 31, 2022 and 2021, respectively, is recorded in other current assets) | 160 | 260 | 360 |
Cash, cash equivalents and restricted cash at end of period | $ 48,418 | $ 30,696 | $ 17,647 |
Statements of Cash Flows (Paren
Statements of Cash Flows (Parenthetical) - USD ($) $ in Thousands | 12 Months Ended | |
Dec. 31, 2022 | Dec. 31, 2021 | |
Statement of Cash Flows [Abstract] | ||
Restricted cash in other current assets | $ 160 | $ 100 |
Restricted Cash, Statement of Financial Position [Extensible Enumeration] | Other current assets | |
Proceeds from royalty purchase and sale agreement | $ 1,900 |
The Company
The Company | 12 Months Ended |
Dec. 31, 2022 | |
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 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 $ 48.3 million as of December 31, 2022. Historically, the Company has funded its operations primarily through the sale of common stock and convertible preferred stock, the issuance of long-term debt, and license agreements. 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. In January 2022, the Company received $ 10.0 million from Bausch + Lomb, a division of Bausch Health Companies, Inc. ("Bausch"), upon completion of pre-launch activities for XIPERE pursuant to the license agreement granting Bausch an exclusive license to develop and commercialize XIPERE in the United States and Canada. Bausch launched XIPERE in the United States in the first quarter of 2022. On August 8, 2022, the Company entered into a Purchase and Sale Agreement (the "Purchase and Sale Agreement") pursuant to which it sold its rights to receive royalty and milestone payments due to the Company from XIPERE and certain SCS Microinjector license agreements subject to a cap which may be increased under certain circumstances. The Company received a payment of $ 32.1 million in September 2022, representing the $ 32.5 million to which the Company was entitled, net of certain of HCR's transaction-related expenses which the Company agreed to reimburse. There were additional issuance costs of $ 1.5 million related to the Purchase and Sale Agreement resulting in net proceeds of $ 30.6 million. 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 year ended December 31, 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. During the year ended December 31, 2022, the Company so ld 425,460 shares of its common stock for net proceeds of $ 0.6 million under its at-the-market agreement with Cowen and Company, LLC. Subsequent to December 31, 2022, the Company sold an additional 214,128 shares of its common stock for net proceeds of $ 0.3 million. 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. In April 2020, we entered into a loan agreement with Silicon Valley Bank under the terms of which Silicon Valley bank loaned us $ 1.0 million, or the PPP Loan, pursuant to the Paycheck Protection Program, or PPP, under the Coronavirus Aid, Relief, and Economic Security Act, or CARES Act. In accordance with the requirements of the CARES Act, we used the proceeds primarily for payroll costs and other eligible expenses. The CARES Act and the PPP provide a mechanism for forgiveness of up to the full amount borrowed. On January 11, 2021, we received notification from Silicon Valley Bank that the PPP Loan was forgiven in full, including approximately $ 7,000 of accrued interest. 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. The Company has no current source of revenue to sustain present activities. The Company does not expect to generate other meaningful revenue until and unless the Company's licensees successfully commercialize XIPERE and the Company has fulfilled its obligations under the Purchase and Sale Agreement, its other licensees receive regulatory approval and successfully commercialize its product candidates, or the Company commercializes its product candidates either on its own or with a third party. 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. 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 complete the development and conduct clinical trials for the regulatory approval of its product candidates if requested by regulatory bodies. If such product candidates 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. Based on its cash and cash equivalents as of the filing date, March 14, 2023, its current plans and forecasted expenses the Company expects that it will be able to fund its planned operating expenses and capital expenditure requirements into the second quarter of 2024. The 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 | 12 Months Ended |
Dec. 31, 2022 | |
Accounting Policies [Abstract] | |
Significant Accounting Policies | 2. Significant Accounting Policies Basis of Presentation and Principles of Consolidation The Company's consolidated financial statements include the results of the financial operations of Clearside Biomedical, Inc. and its wholly-owned subsidiary, Clearside Royalty, LLC. a Delaware limited liability company, which was formed for the purposes of the transactions contemplated by the Purchase and Sale Agreement describe in Note 5. All intercompany balances and transactions have been eliminated. The Company’s financial statements have been prepared in conformity with accounting principles generally accepted in the United States of America (“U.S. GAAP”). Use of Estimates The preparation of consolidated 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 consolidated 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 continues to result in global economic uncertainty. 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 the Company's consolidated financial statements. Revenue Recognition The Company recognizes revenue from its contracts with customers under Financial Accounting Standards Board Accounting Standards Codification (“ASC”) Topic 606, Revenue from Contracts with Customers . 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. Up-front 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. In the year ended December 31, 2022, 2021, and 2020, the Company recognized $ 1.3 million, $ 29.6 million, and $ 7.7 million of revenue associated with its license agreements, respectively. License revenue for the year ended December 31, 2022 was primarily from providing training materials and clinical trial products to the Company's licensees. License revenue for the year ended December 31, 2021 was primarily a result of (i) the milestone payments from Bausch that consisted of $ 5.0 million received upon FDA approval of XIPERE, the recognition of $ 5.0 million of deferred revenue for the upfront milestone payment and the recognition of a $ 10.0 million milestone for pre-launch activities and (ii) an aggregate of $ 8.0 million received from Arctic Vision for FDA approval of XIPERE, territory expansion and certain development milestones. License revenue for the year end December 31, 2020 was primarily a result of milestone payments of $ 4.3 million received from Arctic Vision and $ 3.0 million milestone payment received from REGENXBIO. Segment Information Operating segments are defined as components of an enterprise about which separate discrete information is available for evaluation by the chief operating decision maker, or decision-making group, in deciding how to allocate resources and in assessing performance. The Company views its operations and manages its business in one operating segment. Property and Equipment, Net Property and equipment is recorded at historical cost. Depreciation is calculated using the straight-line method over the estimated useful lives of the related assets, or for leasehold improvement the lesser of the useful life or remaining lease term. Repairs and maintenance are expensed when incurred. Upon retirement or sale, the cost of the assets disposed of and the related accumulated depreciation are removed from the accounts, and any resulting gain or loss is included in the determination of net income. Debt Discount All debt discounts are recorded against the related debt obligation and are amortized using the effective interest rate method over the term of the underlying debt obligation and reflected in interest expense. Income Taxes Deferred tax assets or liabilities are recorded for temporary differences between financial statement and tax basis of assets and liabilities, using enacted rates in effect for the year in which the differences are expected to reverse. A valuation allowance is recorded if it is more likely than not that a deferred tax asset will not be realized. The Company has provided a full valuation allowance on its deferred tax assets, which primarily consist of cumulative net operating losses for the period from May 26, 2011 (inception) to December 31, 2022. Due to its history of operating losses since inception and losses expected to be incurred in the foreseeable future, a full valuation allowance was considered necessary. Liabilities for uncertain tax positions are recognized based on a two-step process. The first step is to evaluate the tax position for recognition by determining if the weight of available evidence indicates that it is more likely than not that the position will be sustained on audit, including resolution of related appeals or litigation processes, if any. Once it is determined that the position meets the recognition threshold, the second step requires estimating and measuring the largest amount of tax benefit that is more likely than not to be realized upon ultimate settlement. The difference between the amount of recognizable tax benefit and the total amount of tax benefit from positions filed or to be filed with the tax authorities is recorded as a liability for uncertain tax benefits. 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 trial activities, are recognized based on an evaluation of the estimated total costs for the clinical trial, progress to completion of specific tasks, using data such as patient enrollment, pass through expenses, clinical site activations, data from the clinical sites 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 contracts and any subsequent amendments, which may differ from the patterns of costs incurred, and are reflected in the financial statements as prepaid or accrued expenses. Share-Based Compensation Compensation cost related to share-based awards granted to employees, directors and consultants is measured based on the estimated fair value of the award at the grant date. 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. Restricted Cash The Company is required to maintain a stand-by letter of credit as a security deposit for its facility lease in Alpharetta, Georgia. The Company’s bank requires the Company to maintain a restricted cash balance to serve as collateral for the letter of credit issued to the landlord by the bank. As of December 31, 2022, the restricted cash balance was invested in a commercial money market account. The current portion of the restricted cash is recorded in other current assets and the long-term portion is recorded in restricted cash. 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. Liability Related to the Sales of Future Royalties and Non-Cash Interest Expense The Company recognizes a liability related to the sales of future royalties under ASC 470-10 Debt and ASC 835-30 Interest - Imputation of Interest. The initial funds received by the Company pursuant to the terms of the Purchase and Sale Agreement were recorded as a liability and will be accreted under the effective interest method up to the estimated amount of future royalties and milestone payments to be made under the Purchase and Sale Agreement. The issuance costs were recorded as a direct deduction to the carrying amount of the liability and will be amortized under the effective interest method over the estimated period the liability will be repaid. The Company estimated the total amount of future royalty revenue and milestone payments to be generated over the life of the Purchase and Sale Agreement, and a significant increase or decrease in these estimates could materially impact the liability balance and the related interest expense. If the timing of the receipt of royalty payments or milestones is materially different from the original estimates, the Company will prospectively adjust the effective interest and the related amortization of the liability and related issuance costs. |
Property and Equipment, Net
Property and Equipment, Net | 12 Months Ended |
Dec. 31, 2022 | |
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 December 31, 2022 2021 Furniture and fixtures 5 $ 249 $ 337 Machinery and equipment 5 343 176 Computer equipment 3 13 13 Leasehold improvements Lesser of or 476 667 Work in process 527 — Total property and equipment 1,608 1,193 Less: Accumulated depreciation ( 853 ) ( 955 ) Property and equipment, net $ 755 $ 238 |
Accrued Liabilities
Accrued Liabilities | 12 Months Ended |
Dec. 31, 2022 | |
Payables and Accruals [Abstract] | |
Accrued Liabilities | 4. Accrued Liabilities Accrued liabilities consisted of the following (in thousands): December 31, 2022 2021 Accrued research and development $ 1,817 $ 1,083 Accrued employee costs 1,837 1,854 Accrued professional fees 49 30 Accrued expense 476 345 $ 4,179 $ 3,312 |
Royalty Purchase and Sale Agree
Royalty Purchase and Sale Agreement | 12 Months Ended |
Dec. 31, 2022 | |
Royalty Purchase and Sales Agreement [Abstract] | |
Royalty Purchase and Sale Agreement | 5. Royalty Purchase and Sale Agreement On August 8, 2022 (the “Closing Date”), the Company, through its wholly-owned subsidiary Clearside Royalty LLC, a Delaware limited liability company (“Royalty Sub”), entered into a Purchase and Sale Agreement (the “Purchase and Sale Agreement”) with entities managed by HealthCare Royalty Management, LLC (“HCR”), pursuant to which Royalty Sub sold to HCR certain of its rights to receive royalty and milestone payments payable to Royalty Sub under the Arctic Vision License Agreement, the Bausch License Agreement, that certain License Agreement, effective as of July 3, 2019, by and between the Company and Aura Biosciences, Inc. (the “Aura License Agreement”), that certain Option and License Agreement, dated as of August 29, 2019, by and between REGENXBIO Inc. and the Company (the “REGENXBIO License Agreement”) and any and all out-license agreements following the Closing Date for, or related to XIPERE or the SCS Microinjector technology (to be used in connection with compounds or products of any third parties) delivered, in whole or in part, by means of the SCS Microinjector technology), excluding, for the avoidance of doubt, any in-licensed or internally developed therapies following the Closing Date (collectively, the “Royalties”), in exchange for up to $ 65 million. In connection with this transaction, the Company assigned the Arctic Vision License Agreement, Bausch License Agreement, Aura License Agreement, REGENXBIO License Agreement, the Company's license agreement with Emory University and The Georgia Tech Research Corporation and related intellectual property rights to Royalty Sub. Under the terms of the Purchase and Sale Agreement, Royalty Sub received an initial payment of $ 32.1 million, representing the $ 32.5 million to which the Company was entitled, net of certain of HCR's transaction-related expenses which the Company agreed to reimburse. There were additional issuance costs of $ 1.5 million related to the Purchase and Sale Agreement resulting in net proceeds of $ 30.6 million. An additional $ 12.5 million was deposited by HCR in an escrow account to be released to Royalty Sub upon attainment of a pre-specified XIPERE sales milestone achieved no later than March 31, 2024. The terms of the Purchase and Sale Agreement also provide for an additional $ 20 million milestone payment to Royalty Sub upon attainment of a second pre-specified sales milestone related to 2024 XIPERE sales (the "Second Milestone Event"). The Purchase and Sale Agreement will automatically expire, and the payment of Royalties from the Royalty Sub to HCR will cease, when HCR has received payments of the Royalties equal to 2.5 times the aggregate amount of payments made by HCR under the Agreement if the Second Milestone Event is achieved on or prior to December 31, 2024 (the “Initial Cap”). If the Second Milestone Event is not achieved on or prior to December 31, 2024, payment of Royalties from Royalty Sub to HCR will cease when HCR has received Royalties payments equal to 3.4 times the aggregate amount of payments under the Purchase and Sale Agreement (the “Alternative Cap”, and together with the Initial Cap, the “Cap Amount”). In the event of a change in control, acquiror will have the option to make a payment to HCR of the Cap Amount then in effect, less the aggregate amount of Royalty payments made by Royalty Sub to HCR under the Purchase and Sale Agreement as a one-time payment at which time, payment of Royalties to HCR will cease. Alternatively, in the event of a change in control, the acquiror will have the option to make an initial payment of 1.0 times the aggregate amount of payments made by HCR under the Purchase and Sale Agreement as of the date of such change in control, then in that event, payment of Royalties from Royalty Sub to HCR will cease when HCR has received total Royalties payments (including the initial payment) equal to the Alternative Cap. After the Purchase and Sale Agreement expires, all rights to receive the Royalties return to Royalty Sub. Issuance costs pursuant to the Purchase and Sale Agreement consisting primarily of advisory and legal fees, totaled $ 1.9 million including the amount of HCR's transaction-related expenses that the Company reimbursed. The effective interest rate includes cash flow projections for future royalty and milestone payments, which are sensitive to certain assumptions, including market size, market penetration and sales price, that are forward looking and could be affected by future market conditions. The following table summarizes the activity of the Purchase and Sale Agreement (in thousands): Royalty purchase and sale agreement effective August 8, 2022 $ 32,500 Issuance costs ( 1,862 ) Non-cash interest expense 3,339 Balance at December 31, 2022 $ 33,977 Effective interest rate 26.5 % |
Long-Term Debt
Long-Term Debt | 12 Months Ended |
Dec. 31, 2022 | |
Debt Disclosure [Abstract] | |
Long-Term Debt | 6. Long-Term Debt Loan and Security Agreements On May 14, 2018, the Company entered into a second amended and restated loan and security agreement (the “2 nd A&R Loan Agreement”) with Silicon Valley Bank (“SVB”), MidCap Funding III Trust and MidCap Financial Trust (together, “MidCap” and collectively with SVB, the “Lenders”). The 2 nd A&R Loan Agreement provided for new term loans of up to $ 20.0 million, with a floating interest rate equal to 6.50 % plus the greater of (i) the 30-day U.S. LIBOR , as reported in the Wall Street Journal on the last business day of the month the immediately precedes the month in which the interest will accrue, or (ii) 1.89 %. The 2 nd A&R Loan Agreement included, among other things, the ability of the Lenders to accelerate the payment of the term loan in the event of a material adverse change and restrictions on the Company’s ability to sell, assign, license, transfer or otherwise dispose of its assets, including intellectual property assets, without the prior written consent of the Lenders. 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 a prior loan agreement, including fees associated with the final payment. The prepayment fees were waived. Of the remaining $ 10.0 million available under the 2 nd A&R loan agreement, the Company elected not to draw $ 5.0 million and the other $ 5.0 million was not available for draw . On October 18, 2019, the Company entered into an amendment to the 2 nd A&R Loan Agreement with the Lenders. Pursuant to the amendment, the Company repaid $ 5.0 million of the outstanding principal balance of the $ 10.0 million term loan. The Company did not pay any final payment or termination fees in connection with the $5.0 million prepayment. In addition, the Company and the Lenders agreed to modify the term loan repayment schedule. As amended, the term loan repayment schedule provided for interest only payments through October 31, 2020, followed by consecutive equal monthly payments of principal and interest in arrears continuing through the maturity date of October 1, 2022 . The Company had the option to prepay the outstanding balance in full, subject to a prepayment fee. A final payment of 5.50 % of the aggregate borrowed amount was due at maturity of the loan on October 1, 2022, or upon the prepayment of the facility or the acceleration of amounts due under the facility as a result of an event of default. The term loans under the 2 nd A&R loan agreement were secured by substantially all of the Company’s assets. On May 7, 2020, due to various restrictions and other limiting covenants of the 2 nd A&R Loan Agreement, the Company prepaid in full the outstanding $ 5.0 million principal balance, plus $ 0.3 million reflecting the final payment fee and accrued interest. The prepayment fees were waived by the Lenders. Interest expense on the borrowings under the loan agreements described above was $ 147,000 for the year ended December 31, 2020. Accretion of the scheduled final payment was $ 59,000 for the year ended December 31, 2020. Accretion of the deferred closing costs was $ 129,000 for the year ended December 31, 2020. |
CARES Act Paycheck Protection P
CARES Act Paycheck Protection Program Loan | 12 Months Ended |
Dec. 31, 2022 | |
Unusual or Infrequent Items, or Both [Abstract] | |
CARES Act Paycheck Protection Program Loan | 7. CARES Act Paycheck Protection Program Loan On April 20, 2020, the Company entered into a loan agreement with SVB (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 was 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. |
Preferred and Common Stock
Preferred and Common Stock | 12 Months Ended |
Dec. 31, 2022 | |
Equity [Abstract] | |
Preferred and Common Stock | 8. Preferred and Common Stock The Company’s amended and restated certificate of incorporation authorizes the Company to issue 10,000,000 shares of $ 0.001 par value of preferred stock. As of December 31, 2022 and 2021, there were 10,000,000 shares of preferred stock authorized, no ne of which were issued and outstanding. At the Company's Annual Meeting of Stockholders held on June 22, 2022, the Company's stockholders approved an amendment to the amended and restated certificate of incorporation to increase the Company's authorized number of shares of common stock from 100,000,000 shares to 200,000,000 shares. As of December 31, 2022 the Company was authorized to issue 200,000,000 shares of $ 0.001 par value common stock. As of December 31, 2022 and 2021, there were 60,639,827 and 59,722,930 shares of common stock outstanding, respectively. |
Common Stock Warrants
Common Stock Warrants | 12 Months Ended |
Dec. 31, 2022 | |
Common Stock Warrants [Abstract] | |
Common Stock Warrants | 9. Common Stock Warrants In September 2016, in connection with a loan agreement, the Company issued warrants to the lenders to purchase up to 29,796 shares of common stock at a price per share of $ 10.74 . The warrants are fully exercisable and expire in September 2026 , or earlier upon the occurrence of specified mergers or acquisitions of the Company. The warrants were recorded in equity at the time of issuance and had a remaining life of 3.75 years as of December 31, 2022. |
Share-Based Compensation
Share-Based Compensation | 12 Months Ended |
Dec. 31, 2022 | |
Share-Based Payment Arrangement [Abstract] | |
Share-Based Compensation | 10. Share-Based Compensation Stock Options In January 2016, the Company’s board of directors adopted and approved the Clearside Biomedical, Inc. 2016 Equity Incentive Plan (the “2016 Plan”) which became effective on June 1, 2016. The 2016 Plan provides for the grant of share-based awards to employees, directors and consultants of the Company. The 2016 Plan provides for the grant of incentive stock options to employees, and for the grant of nonqualified stock options, restricted stock awards, restricted stock unit awards, stock appreciation rights, performance stock awards and other forms of stock compensation to the Company’s employees, directors, and non-employee third parties. The number of shares of common stock reserved for issuance under the 2016 Plan will automatically increase on January 1 each year, through January 1, 2026, by 4 % of the total number of shares of the Company’s common stock outstanding on December 31 of the preceding calendar year, or a lesser number of shares as may be determined by the Company’s board of directors. At December 31, 2022, under the 2016 Plan, options to purchase 6,590,838 shares of the Company’s common stock were outstanding at a weighted average price of $ 3.59 per share and 1,035,374 shares remained available for future grant. As of January 1, 2023, the number of shares of common stock that may be issued under the 2016 Plan was automatically increased by 2,425,593 shares, representing 4 % of the total number of shares of common stock outstanding on December 31, 2022, increasing the number of shares of common stock available for issuance under the 2016 Plan as of that date to 3,460,967 shares. As a result of the adoption of the 2016 Plan, no further grants may be made under the Company’s 2011 Stock Incentive Plan (the “2011 Plan”). The 2011 Plan provided for the grant of share-based awards to employees, directors and consultants of the Company. At December 31, 2022, options to purchase 307,256 shares of the Company’s common stock were outstanding under the 2011 Plan at a weighted average exercise price of $ 3.26 per share. The Company has granted stock option awards to employees, directors and consultants. The total share-based compensation expense recognized is reflected in the statements of operations as follows (in thousands): Year Ended 2022 2021 2020 Research and development $ 1,616 $ 1,570 $ 1,183 General and administrative 1,785 1,985 1,574 Total $ 3,401 $ 3,555 $ 2,757 Share-based compensation is accounted for in accordance with the provisions of ASC 718, Compensation-Stock Compensation . 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. The following table sets forth the weighted average assumptions utilized in the Black-Scholes option pricing model to calculate the fair value of the underlying common stock for the years ended December 31, 2022, 2021 and 2020. Year Ended 2022 2021 2020 Expected term (years) 6.00 7.00 7.00 Expected stock price volatility 98.24 % 101.43 % 108.13 % Risk-free interest rate 2.09 % 0.75 % 1.52 % Expected dividend yield 0.00 % 0.00 % 0.00 % Expected term (in years): In the year ended December 31, 2022, the Company began using historical data to calculate the expected term. In the years ended December 31, 2021 and 2020, the Company utilized the simplified method as prescribed by ASC 718, as the Company did not have sufficient historical exercise and post-vesting termination data to provide a reasonable basis upon which to estimate the expected term of stock options granted to employees. Risk-free interest rate : The risk-free interest rate is based on the yields of U.S. Treasury securities with maturities similar to the expected time to a possible liquidity event. Expected dividend yield : The Company has not paid and does not anticipate paying any dividends in the foreseeable future. Expected stock price volatility : The Company calculates expected volatility based on the historical volatility of its common stock. Forfeitures: The Company records forfeitures as they occur. The following table summarizes the activity related to stock options during the year ended December 31, 2022: Weighted Number of Average Shares Exercise Price Options outstanding at December 31, 2021 5,762,328 $ 4.07 Granted 1,782,440 1.98 Exercised ( 49,187 ) 0.35 Forfeited or expired ( 580,251 ) 3.73 Options outstanding at December 31, 2022 6,915,330 3.58 Options exercisable at December 31, 2021 3,148,502 4.59 Options exercisable at December 31, 2022 4,223,931 4.22 The following table provides additional information about the Company’s stock options that were outstanding and exercisable at December 31, 2022 (aggregate intrinsic values in thousands): Weighted Weighted Weighted Average Weighted Average Average Aggregate Remaining Average Aggregate Remaining Exercise Options Exercise Intrinsic Contractual Options Exercise Intrinsic Contractual Price Outstanding Price Value Life (Years) Exercisable Price Value Life (Years) $ 0.00 - $ 2.99 3,777,873 7.61 1,865,987 6.31 $ 3.00 - $ 6.99 2,506,371 6.85 1,726,858 6.30 $ 7.00 - $ 8.99 429,308 4.17 429,308 4.17 $ 9.00 - $ 20.84 201,778 4.76 201,778 4.76 6,915,330 $ 3.58 $ 66 7.03 4,223,931 $ 4.22 $ 64 6.02 As of December 31, 2022, the Company had $ 4.4 million of unrecognized compensation expense related to unvested stock options, which is expected to be recognized over a weighted average period of 2.3 years. The weighted average fair values of all stock options granted for the years ended December 31, 2022, 2021 and 2020 was $ 1.55 per share, $ 3.24 per share and $ 1.97 per share, respectively. The intrinsic value is calculated as the difference between the fair market value and the exercise price per share of the stock options. The fair market value per share of common stock as of December 30, 2022 was $ 1.12 , which was the closing sale price of the Company’s common stock on the Nasdaq Global Market on that date. Restricted Stock Units The Company has granted restricted stock units (“RSUs”) to employees under the 2016 Plan. The shares underlying the RSU awards have vesting terms of 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): Year Ended 2022 2021 2020 Research and development $ 794 $ 723 $ 375 General and administrative 658 715 427 Total $ 1,452 $ 1,438 $ 802 The following table summarizes the activity related to RSUs during the year ended December 31, 2022: Weighted Average Number of Grant Date Shares Fair Value Non-vested RSUs outstanding at December 31, 2021 1,317,347 $ 3.58 Granted 648,460 2.19 Vested ( 375,331 ) 3.44 Forfeited ( 127,544 ) 3.04 Non-vested RSUs outstanding at December 31, 2022 1,462,932 3.04 As of December 31, 2022, the Company had $ 3.1 million of unrecognized compensation expense related to the RSUs, which amount is expected to be recognized over a weighted average period of 2.3 years. Employee Stock Purchase Plan In January 2016, the Company’s board of directors adopted and approved the Clearside Biomedical, Inc. 2016 Employee Stock Purchase Plan (the “2016 ESPP”) which became effective on June 1, 2016. The 2016 ESPP permits employees to purchase shares of the Company’s common stock through payroll deductions up to 15 % of their earnings. The number of shares reserved for issuance under the 2016 ESPP will automatically increase on January 1 of each year, through January 1, 2026, by the lesser of (i) 1% of the total number of shares of the Company’s common stock outstanding on December 31 of the preceding calendar year, (ii) 454,545 shares of common stock or (iii) a lesser number of shares as may be determined by the Company’s board of directors . The Company’s board of directors elected not to increase the shares reserved for issuance on January 1, 2023. The number of shares of common stock available for issuance under the 2016 ESPP as of December 31, 2022 was 438,572 shares. 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. During the years ended December 31, 2022, 2021 and 2020, the Company issued 66,919 , 65,481 and 35,359 shares, respectively, of common stock purchased under the 2016 ESPP. The share-based compensation expense recognized for the 2016 ESPP is reflected in the statements of operations and comprehensive loss as follows (in thousands): Year Ended 2022 2021 2020 Research and development $ 21 $ 41 $ 19 General and administrative 10 20 22 Total $ 31 $ 61 $ 41 |
Income Taxes
Income Taxes | 12 Months Ended |
Dec. 31, 2022 | |
Income Tax Disclosure [Abstract] | |
Income Taxes | 11. Income Taxes Deferred income taxes reflect the net tax effects of temporary differences between the carrying amounts of assets and liabilities for financial reporting purposes and the amounts used for income tax purposes. Significant components of the Company’s net deferred income tax assets consist of the following (in thousands): December 31, 2022 2021 2020 Deferred tax asset (liability): Net operating loss carryforwards $ 50,267 $ 53,966 $ 51,414 Non-deductible accrued expenses 386 469 263 Right-of-use asset ( 238 ) ( 96 ) ( 132 ) Lease liability 274 176 247 Deferred revenue — — 1,247 Stock compensation expense 2,678 2,768 2,044 Depreciation differences ( 40 ) ( 44 ) ( 82 ) Federal tax credits 9,742 9,012 8,015 State tax credits 326 342 381 Disallowed interest expense — — 7 Charitable contributions — 6 — Royalty purchase and sale agreement 7,247 — — Capitalized research and development expenses 3,057 — — Valuation allowance ( 73,699 ) ( 66,599 ) ( 63,404 ) Net deferred tax asset $ — $ — $ — A reconciliation of the statutory tax rates and the effective tax rates is as follows: Year Ended December 31, 2022 2021 2020 U.S. federal tax rate 21.00 % 21.00 % 21.00 % State tax rate ( 0.85 ) ( 599.32 ) 14.28 Permanent difference ( 1.34 ) ( 3.15 ) 1.42 Tax credit 2.18 ( 253.97 ) 2.89 Valuation allowance ( 21.57 ) 847.82 ( 39.66 ) ASC 740-10 — ( 3.19 ) ( 0.26 ) Adjustment to prior year tax provision 0.67 ( 13.16 ) — Other ( 0.09 ) 3.97 — 0.00 % 0.00 % ( 0.33 )% Certain items of income and expense are not reported in tax returns and financial statements in the same year. The tax effect of such temporary differences is reported as deferred income taxes. The measurement of deferred tax assets is reduced, if necessary, by the amount of any tax benefit that, based on available evidence, is not expected to be realized. The Company establishes a valuation allowance for deferred tax assets for which realization is not likely. As of each reporting date, management considers new evidence, both positive and negative, that could affect its view of the future realization of deferred tax assets. At December 31, 2022, the Company had a valuation allowance of $ 73.7 million recorded against the benefit of certain deferred tax assets. The valuation allowance was primarily related to federal and state net operating loss ("NOL") carryforwards that, in the judgment of management, are not more likely than not to be realized. In assessing the recoverability of the Company’s deferred tax assets, management considered, among other things, its deferred tax liabilities, its historical earnings and losses, projections of future income, and tax-planning strategies available to the Company in the relevant jurisdiction. The Company will release this valuation allowance when management determines that it is more likely than not that its deferred tax asset will be realized. At December 31, 2022, the Company had income tax NOL carryforwards for federal and state purposes of $ 216.1 million and $ 78.4 million, respectively. The Company has recorded a deferred tax asset for both federal and state NOL carryforwards of $ 45.4 million and $ 4.9 million, respectively. If not utilized, the federal NOL carryforwards will begin to expire beginning in 2031 , and the state NOL carryforwards will begin to expire at various dates beginning in 2027 . Additionally, under the 2017 Tax Cuts and Jobs Act, federal net operating losses incurred in 2018 and beyond may be carried forward indefinitely. However, the deductibility of such federal net operating losses is limited beginning in 2021. Certain states have also adopted the indefinite carryforward period beginning with the 2018 tax year, but state conformity varies state by state. Liabilities for uncertain tax positions are recognized based on a two-step process. The first step is to evaluate the tax position for recognition by determining if the weight of available evidence indicates that it is more likely than not that the position will be sustained on audit, including resolution of related appeals or litigation processes, if any. Once it is determined that the position meets the recognition threshold, the second step requires the Company to estimate and measure the largest amount of tax benefit that is more likely than not to be realized upon ultimate settlement. The difference between the amount of recognizable tax benefit and the total amount of tax benefit from positions filed or to be filed with the tax authorities is recorded as a liability for uncertain tax benefits. The following is a roll forward of the Company’s uncertain tax positions (in thousands): Year Ended December 31, 2022 2021 Balance of uncertain tax positions at the beginning of the year $ 7,520 $ 7,568 Gross decreases - tax positions in prior period — ( 12 ) Gross decreases - settlements with taxing authorities — ( 36 ) Balance of uncertain tax positions at the end of the year $ 7,520 $ 7,520 As of December 31, 2022 and 2021, there was $ 7.5 million in each period of unrecognized tax benefit that if recognized would be in the form of a net operating loss carryforward, which is expected to require a full valuation allowance based on present circumstances. The Company reversed $ 48,000 of previously recorded unrecognized tax expenses for the year 2021. The Company recognizes accrued interest related to unrecognized tax expenses and penalties as income tax expense. No significant amounts of interest or penalties have been recorded as of December 31, 2022. Ownership changes, as defined by Section 382 of the Internal Revenue Code of 1986, as amended (the “Code”), may limit the amount of net operating losses that a company may utilize to offset future taxable income and taxes payable. In general, if the Company experiences a greater than 50% aggregate change in ownership over a 3-year period (a Section 382 ownership change), utilization of the Company’s pre-change NOL carryforwards may be subject to limitation under the Code. The annual limitation generally is determined by multiplying the value of the Company’s stock at the time of such ownership change (subject to certain adjustments) by the applicable long-term tax-exempt rate for the month in which the ownership change occurred. Such limitation may result in expiration of a portion of the NOL carryforwards before utilization. The Company has completed an owner shift analysis to determine the dates in which the Company may have experienced a Section 382 ownership change, and determined that the Company experienced ownership changes for Section 382 purposes in January 2012, December 2013, and July 2016. Further, the Company has determined that $ 38,000 and $ 2,000 of its deferred tax asset related to Federal NOL and Federal R&D Credit, respectively, will expire due to Section 382. The NOL DTA has a full valuation allowance as it is deemed that it is more likely than not to be utilized. The Company will continue to monitor equity movement and its impact on the utilization of the NOLs and credits. The Company’s ability to use the remaining NOL carryforwards may be further limited if the Company experiences an additional Section 382 ownership change as a result of future changes in its stock ownership. The Company is subject to taxation in the United States and certain state jurisdictions. As of December 31, 2022, the Company’s tax returns for 2019, 2020 and 2021 are subject to full examination by the tax authorities. As of December 31, 2022, the Company is generally no longer subject to state or local examinations by tax authorities for years before 2019, except to the extent of NOLs generated in prior years claimed on a tax return. |
Commitment and Contingencies
Commitment and Contingencies | 12 Months Ended |
Dec. 31, 2022 | |
Commitments and Contingencies Disclosure [Abstract] | |
Commitments and Contingencies | 12. Commitments and Contingencies Lease Commitment Summary The Company leases its facilities and some of its equipment under noncancelable operating lease arrangements that expire at various dates through 2023. 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 was for a six and one-half year term with a renewal option for one additional five-year term. Rental payments were $ 35,145 per month subject to an increase of 3 % per year. In November 2022, the Company amended the office lease agreement and decreased the square footage to approximately 14,000 square feet. The amended office lease agreement is for a four year term with a renewal option for an additional thirty-eight months . Rental payments are $ 30,437 per month subject to an increase of 3 % per year. Operating lease cost under this lease and the amendment is recognized on a straight-line basis over the term of the lease. In addition, the office 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): December 31, Operating lease right-of-use asset $ 1,117 Liabilities Current portion of operating lease liabilities $ 349 Operating lease liabilities 936 Total operating lease liabilities $ 1,285 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 is not reasonably certain 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 December 31, 2022, the Company’s incremental borrowing rate was 8.0 % and the remaining lease term was 4.0 years. Cash payments included in operating activities on the consolidated statement of cash flows for operating lease liabilities were $ 339,000 , $ 392,000 and $ 378,000 for the years ended December 31, 2022, 2021 and 2020, respectively. Minimum lease payments were as follows at December 31, 2022 (in thousands): Year ending December 31, 2023 $ 362 2024 378 2025 389 2026 367 Total minimum lease payments 1,496 Less imputed interest ( 211 ) Total operating lease liabilities $ 1,285 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 $ 262,000 for the year ended December 31, 2022 and $ 247,000 for each of the years ended December 31, 2021 and 2020. Variable lease cost was $ 87,000 for the year ended December 31, 2022 and $ 95,000 for the years ended December 31, 2021 and 2020. Short-term lease cost was $ 86,000 , $ 12,000 and $ 20,000 for the years ended December 31, 2022, 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. In May 2018, the Company entered into a manufacturing supply agreement (the “Supply Agreement”), with Gerresheimer Regensburg GmbH, a company incorporated under the laws of Germany (“Gerresheimer”). Gerresheimer will manufacture and supply the Company’s proprietary SCS Microinjector. The Company will provide Gerresheimer with a rolling forecast schedule of its projected purchase orders for at least the next four calendar quarters. The Supply Agreement contains an initial five-year term that will automatically renew for successive periods of three years , unless terminated by either party at least 12 months prior to the end of the applicable term. |
License and Other Agreements
License and Other Agreements | 12 Months Ended |
Dec. 31, 2022 | |
License And Other Agreement [Abstract] | |
License and Other Agreements | 13. License and Other Agreements Bausch + Lomb On October 22, 2019, the Company entered into a License Agreement (as amended, the "Bausch 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 SCS 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. Pursuant to the Bausch License Agreement, Bausch paid the Company an upfront payment of $ 5.0 million (the “Upfront Payment”) in October 2019. In October 2021, the FDA approved XIPERE. The Company received $ 5.0 million from Bausch as a result of the approval. In December 2021, $ 10.0 million was recorded upon completion of pre-launch activities for XIPERE and payment was received in January 2022. 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 specified 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 launched XIPERE in the United States in the first quarter of 2022. The Company's rights to these royalties and milestone payments have been sold pursuant to the terms and conditions of the Purchase and Sale Agreement described in Note 5 to the consolidated financial statements. 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. Following FDA approval of XIPERE, Bausch is responsible for all such expenses. Due to the refund provisions in the License Agreement, the Upfront Payment was included on the balance sheet as deferred revenue as of December 31, 2020. The refund provisions lapsed upon FDA approval of XIPERE and the $ 5.0 million was recognized as revenue in the fourth quarter of 2021. REGENXBIO, Inc . 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”), which grants 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 endoth elial growth factor treatment is currently the standard of care. REGENXBIO exercised the Option in October 2019 and paid the Company an option fee equal to $ 2.0 million, less a credit of $ 0.5 million previously received under a technology access agreement. In addition, REGENXBIO has agreed to pay the Company up to an aggregate of $ 31.0 million in milestone payments upon the achievement of specified development milestones and up to an aggregate of $ 102.0 million in sales-based milestone payments, as well as mid-single digit royalties on net sales of products using the SCS Microinjector during the royalty term. In September 2020, the Company received $ 3.0 milli on in milestone payments under the Option. The Company's rights to these royalties and milestone payments have been sold pursuant to the terms and conditions of the Purchase and Sale Agreement described in Note 5 to the consolidated financial statements. 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 December 2021, the Company received a milestone paym ent of $ 4.0 million following the receipt of FDA approval of XIPERE in the United States. In addition, Arctic Vision has agreed to pay the Company up to $ 22.5 million in development and sales milestones. Further, dur ing the applicable royalty term, the Company will also be entitled to receive tiered royalties of ten to twelve percent of net sales based on achieving certain annual net sales thresholds in the Arctic Territory, subject to customary reductions, payable on a product-by-product and country-by-country basis, commencing at launch in such country and lasting until the latest of (i) the date that all valid claims within the licensed patent rights covering XIPERE have expired, (ii) the date of the loss of marketing or regulatory exclusivity of XIPERE in a given country, or (iii) ten years from the first commercial sale of XIPERE in a given country. The Company's rights to these royalties and milestone payments have been sold pursuant to the terms and conditions of the Purchase and Sale Agreement described in Note 5 to the consolidated financial statements. 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. The Company recorded $ 13,000 , $ 200,000 and $ 105,000 of revenue from these agreements during the years ended December 31, 2021, 2020 and 2019, respectively. |
Fair Value Measurements
Fair Value Measurements | 12 Months Ended |
Dec. 31, 2022 | |
Fair Value Disclosures [Abstract] | |
Fair Value Measurements | 14. Fair Value Measurements The Company’s material financial instruments at December 31, 2022 and 2021, consisted primarily of cash and cash equivalents. The fair value 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 liability related to the sales of future royalties approximates the carrying value due to the short period of time that has elapsed from the origination date. There were no transfers between Levels 1, 2 and 3 during the years ended December 31, 2022 and 2021. |
Net Income (Loss) Per Share
Net Income (Loss) Per Share | 12 Months Ended |
Dec. 31, 2022 | |
Earnings Per Share [Abstract] | |
Net Income (Loss) Per Share | 15. Net Income (Loss) Per Share Basic net income (loss) per share is calculated by dividing the net income (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 income (loss) per share gives effect to all dilutive potential shares of common stock outstanding during this period. For periods in which the Company incurred net losses, common stock equivalents were excluded which included stock options, unvested restricted stock 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. Year Ended December 31, 2022 2021 2020 Net (loss) income - basic and diluted $ ( 32,947 ) $ 376 $ ( 18,210 ) Weighted average shares - basic 60,204,862 58,491,986 46,506,540 Effect of dilutive securities: Stock options — 1,058,134 — Restricted stock — 342,943 — ESPP — 13,539 — Weighted average shares - diluted 60,204,862 59,906,602 46,506,540 Net (loss) income per share - basic $ ( 0.55 ) $ 0.01 $ ( 0.39 ) Net (loss) income per share - diluted $ ( 0.55 ) $ 0.01 $ ( 0.39 ) The Company’s potential common stock equivalents that have been excluded from the computation of diluted net income (loss) per share for all periods presented because of their antidilutive effect consisted of the following: Year Ended 2022 2021 2020 Outstanding stock options 6,915,330 4,704,194 4,248,193 Non-vested restricted stock units 1,462,932 974,404 767,271 Stock purchase warrants 29,796 29,796 29,796 8,408,058 5,708,394 5,045,260 |
Significant Accounting Polici_2
Significant Accounting Policies (Policies) | 12 Months Ended |
Dec. 31, 2022 | |
Accounting Policies [Abstract] | |
Basis of Presentation | Basis of Presentation and Principles of Consolidation The Company's consolidated financial statements include the results of the financial operations of Clearside Biomedical, Inc. and its wholly-owned subsidiary, Clearside Royalty, LLC. a Delaware limited liability company, which was formed for the purposes of the transactions contemplated by the Purchase and Sale Agreement describe in Note 5. All intercompany balances and transactions have been eliminated. The Company’s financial statements have been prepared in conformity with accounting principles generally accepted in the United States of America (“U.S. GAAP”). |
Use of Estimates | Use of Estimates The preparation of consolidated 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 consolidated 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 continues to result in global economic uncertainty. 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 the Company's consolidated financial statements. |
Revenue Recognition | Revenue Recognition The Company recognizes revenue from its contracts with customers under Financial Accounting Standards Board Accounting Standards Codification (“ASC”) Topic 606, Revenue from Contracts with Customers . 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. Up-front 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. In the year ended December 31, 2022, 2021, and 2020, the Company recognized $ 1.3 million, $ 29.6 million, and $ 7.7 million of revenue associated with its license agreements, respectively. License revenue for the year ended December 31, 2022 was primarily from providing training materials and clinical trial products to the Company's licensees. License revenue for the year ended December 31, 2021 was primarily a result of (i) the milestone payments from Bausch that consisted of $ 5.0 million received upon FDA approval of XIPERE, the recognition of $ 5.0 million of deferred revenue for the upfront milestone payment and the recognition of a $ 10.0 million milestone for pre-launch activities and (ii) an aggregate of $ 8.0 million received from Arctic Vision for FDA approval of XIPERE, territory expansion and certain development milestones. License revenue for the year end December 31, 2020 was primarily a result of milestone payments of $ 4.3 million received from Arctic Vision and $ 3.0 million milestone payment received from REGENXBIO. |
Segment Information | Segment Information Operating segments are defined as components of an enterprise about which separate discrete information is available for evaluation by the chief operating decision maker, or decision-making group, in deciding how to allocate resources and in assessing performance. The Company views its operations and manages its business in one operating segment. |
Property and Equipment, Net | Property and Equipment, Net Property and equipment is recorded at historical cost. Depreciation is calculated using the straight-line method over the estimated useful lives of the related assets, or for leasehold improvement the lesser of the useful life or remaining lease term. Repairs and maintenance are expensed when incurred. Upon retirement or sale, the cost of the assets disposed of and the related accumulated depreciation are removed from the accounts, and any resulting gain or loss is included in the determination of net income. |
Debt Discount | Debt Discount All debt discounts are recorded against the related debt obligation and are amortized using the effective interest rate method over the term of the underlying debt obligation and reflected in interest expense. |
Income Taxes | Income Taxes Deferred tax assets or liabilities are recorded for temporary differences between financial statement and tax basis of assets and liabilities, using enacted rates in effect for the year in which the differences are expected to reverse. A valuation allowance is recorded if it is more likely than not that a deferred tax asset will not be realized. The Company has provided a full valuation allowance on its deferred tax assets, which primarily consist of cumulative net operating losses for the period from May 26, 2011 (inception) to December 31, 2022. Due to its history of operating losses since inception and losses expected to be incurred in the foreseeable future, a full valuation allowance was considered necessary. Liabilities for uncertain tax positions are recognized based on a two-step process. The first step is to evaluate the tax position for recognition by determining if the weight of available evidence indicates that it is more likely than not that the position will be sustained on audit, including resolution of related appeals or litigation processes, if any. Once it is determined that the position meets the recognition threshold, the second step requires estimating and measuring the largest amount of tax benefit that is more likely than not to be realized upon ultimate settlement. The difference between the amount of recognizable tax benefit and the total amount of tax benefit from positions filed or to be filed with the tax authorities is recorded as a liability for uncertain tax benefits. |
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 trial activities, are recognized based on an evaluation of the estimated total costs for the clinical trial, progress to completion of specific tasks, using data such as patient enrollment, pass through expenses, clinical site activations, data from the clinical sites 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 contracts and any subsequent amendments, which may differ from the patterns of costs incurred, and are reflected in the financial statements as prepaid or accrued expenses. |
Share-Based Compensation | Share-Based Compensation Compensation cost related to share-based awards granted to employees, directors and consultants is measured based on the estimated fair value of the award at the grant date. 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. |
Restricted Cash | Restricted Cash The Company is required to maintain a stand-by letter of credit as a security deposit for its facility lease in Alpharetta, Georgia. The Company’s bank requires the Company to maintain a restricted cash balance to serve as collateral for the letter of credit issued to the landlord by the bank. As of December 31, 2022, the restricted cash balance was invested in a commercial money market account. The current portion of the restricted cash is recorded in other current assets and the long-term portion is recorded in restricted cash. |
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. |
Liability Related to the Sales of Future Royalties and Non-Cash Interest Expense | Liability Related to the Sales of Future Royalties and Non-Cash Interest Expense The Company recognizes a liability related to the sales of future royalties under ASC 470-10 Debt and ASC 835-30 Interest - Imputation of Interest. The initial funds received by the Company pursuant to the terms of the Purchase and Sale Agreement were recorded as a liability and will be accreted under the effective interest method up to the estimated amount of future royalties and milestone payments to be made under the Purchase and Sale Agreement. The issuance costs were recorded as a direct deduction to the carrying amount of the liability and will be amortized under the effective interest method over the estimated period the liability will be repaid. The Company estimated the total amount of future royalty revenue and milestone payments to be generated over the life of the Purchase and Sale Agreement, and a significant increase or decrease in these estimates could materially impact the liability balance and the related interest expense. If the timing of the receipt of royalty payments or milestones is materially different from the original estimates, the Company will prospectively adjust the effective interest and the related amortization of the liability and related issuance costs. |
Property and Equipment, Net (Ta
Property and Equipment, Net (Tables) | 12 Months Ended |
Dec. 31, 2022 | |
Property, Plant and Equipment [Abstract] | |
Schedule of Property and Equipment, Net | Property and equipment, net consisted of the following (dollar amounts in thousands): Estimated December 31, 2022 2021 Furniture and fixtures 5 $ 249 $ 337 Machinery and equipment 5 343 176 Computer equipment 3 13 13 Leasehold improvements Lesser of or 476 667 Work in process 527 — Total property and equipment 1,608 1,193 Less: Accumulated depreciation ( 853 ) ( 955 ) Property and equipment, net $ 755 $ 238 |
Accrued Liabilities (Tables)
Accrued Liabilities (Tables) | 12 Months Ended |
Dec. 31, 2022 | |
Payables and Accruals [Abstract] | |
Schedule of Accrued Liabilities | Accrued liabilities consisted of the following (in thousands): December 31, 2022 2021 Accrued research and development $ 1,817 $ 1,083 Accrued employee costs 1,837 1,854 Accrued professional fees 49 30 Accrued expense 476 345 $ 4,179 $ 3,312 |
Royalty Purchase and Sale Agr_2
Royalty Purchase and Sale Agreement (Tables) | 12 Months Ended |
Dec. 31, 2022 | |
Royalty Purchase and Sales Agreement [Abstract] | |
Schedule of activity of the royalty obligation | The following table summarizes the activity of the Purchase and Sale Agreement (in thousands): Royalty purchase and sale agreement effective August 8, 2022 $ 32,500 Issuance costs ( 1,862 ) Non-cash interest expense 3,339 Balance at December 31, 2022 $ 33,977 Effective interest rate 26.5 % |
Share-Based Compensation (Table
Share-Based Compensation (Tables) | 12 Months Ended |
Dec. 31, 2022 | |
Summary of Share-based Compensation Expense | The Company has granted stock option awards to employees, directors and consultants. The total share-based compensation expense recognized is reflected in the statements of operations as follows (in thousands): Year Ended 2022 2021 2020 Research and development $ 1,616 $ 1,570 $ 1,183 General and administrative 1,785 1,985 1,574 Total $ 3,401 $ 3,555 $ 2,757 |
Weighted Average Assumptions Used in Black-Scholes Option Pricing Model to Calculate Fair Value of Underlying Common Stock | The following table sets forth the weighted average assumptions utilized in the Black-Scholes option pricing model to calculate the fair value of the underlying common stock for the years ended December 31, 2022, 2021 and 2020. Year Ended 2022 2021 2020 Expected term (years) 6.00 7.00 7.00 Expected stock price volatility 98.24 % 101.43 % 108.13 % Risk-free interest rate 2.09 % 0.75 % 1.52 % Expected dividend yield 0.00 % 0.00 % 0.00 % |
Summary of Activity Related to Stock Options | The following table summarizes the activity related to stock options during the year ended December 31, 2022: Weighted Number of Average Shares Exercise Price Options outstanding at December 31, 2021 5,762,328 $ 4.07 Granted 1,782,440 1.98 Exercised ( 49,187 ) 0.35 Forfeited or expired ( 580,251 ) 3.73 Options outstanding at December 31, 2022 6,915,330 3.58 Options exercisable at December 31, 2021 3,148,502 4.59 Options exercisable at December 31, 2022 4,223,931 4.22 |
Additional Information about the Stock Option Outstanding and Exercisable | The following table provides additional information about the Company’s stock options that were outstanding and exercisable at December 31, 2022 (aggregate intrinsic values in thousands): Weighted Weighted Weighted Average Weighted Average Average Aggregate Remaining Average Aggregate Remaining Exercise Options Exercise Intrinsic Contractual Options Exercise Intrinsic Contractual Price Outstanding Price Value Life (Years) Exercisable Price Value Life (Years) $ 0.00 - $ 2.99 3,777,873 7.61 1,865,987 6.31 $ 3.00 - $ 6.99 2,506,371 6.85 1,726,858 6.30 $ 7.00 - $ 8.99 429,308 4.17 429,308 4.17 $ 9.00 - $ 20.84 201,778 4.76 201,778 4.76 6,915,330 $ 3.58 $ 66 7.03 4,223,931 $ 4.22 $ 64 6.02 |
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): Year Ended 2022 2021 2020 Research and development $ 21 $ 41 $ 19 General and administrative 10 20 22 Total $ 31 $ 61 $ 41 |
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): Year Ended 2022 2021 2020 Research and development $ 794 $ 723 $ 375 General and administrative 658 715 427 Total $ 1,452 $ 1,438 $ 802 |
Summary of the Activity Related to RSUs | The following table summarizes the activity related to RSUs during the year ended December 31, 2022: Weighted Average Number of Grant Date Shares Fair Value Non-vested RSUs outstanding at December 31, 2021 1,317,347 $ 3.58 Granted 648,460 2.19 Vested ( 375,331 ) 3.44 Forfeited ( 127,544 ) 3.04 Non-vested RSUs outstanding at December 31, 2022 1,462,932 3.04 |
Income Taxes (Tables)
Income Taxes (Tables) | 12 Months Ended |
Dec. 31, 2022 | |
Income Tax Disclosure [Abstract] | |
Schedule of Net Deferred Tax Assets | Significant components of the Company’s net deferred income tax assets consist of the following (in thousands): December 31, 2022 2021 2020 Deferred tax asset (liability): Net operating loss carryforwards $ 50,267 $ 53,966 $ 51,414 Non-deductible accrued expenses 386 469 263 Right-of-use asset ( 238 ) ( 96 ) ( 132 ) Lease liability 274 176 247 Deferred revenue — — 1,247 Stock compensation expense 2,678 2,768 2,044 Depreciation differences ( 40 ) ( 44 ) ( 82 ) Federal tax credits 9,742 9,012 8,015 State tax credits 326 342 381 Disallowed interest expense — — 7 Charitable contributions — 6 — Royalty purchase and sale agreement 7,247 — — Capitalized research and development expenses 3,057 — — Valuation allowance ( 73,699 ) ( 66,599 ) ( 63,404 ) Net deferred tax asset $ — $ — $ — |
Schedule of Statutory and Effective Income Tax Rate Reconciliation | A reconciliation of the statutory tax rates and the effective tax rates is as follows: Year Ended December 31, 2022 2021 2020 U.S. federal tax rate 21.00 % 21.00 % 21.00 % State tax rate ( 0.85 ) ( 599.32 ) 14.28 Permanent difference ( 1.34 ) ( 3.15 ) 1.42 Tax credit 2.18 ( 253.97 ) 2.89 Valuation allowance ( 21.57 ) 847.82 ( 39.66 ) ASC 740-10 — ( 3.19 ) ( 0.26 ) Adjustment to prior year tax provision 0.67 ( 13.16 ) — Other ( 0.09 ) 3.97 — 0.00 % 0.00 % ( 0.33 )% |
Summary of Activity Related to Uncertain Tax Positions | The following is a roll forward of the Company’s uncertain tax positions (in thousands): Year Ended December 31, 2022 2021 Balance of uncertain tax positions at the beginning of the year $ 7,520 $ 7,568 Gross decreases - tax positions in prior period — ( 12 ) Gross decreases - settlements with taxing authorities — ( 36 ) Balance of uncertain tax positions at the end of the year $ 7,520 $ 7,520 |
Commitment and Contingencies (T
Commitment and Contingencies (Tables) | 12 Months Ended |
Dec. 31, 2022 | |
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): December 31, Operating lease right-of-use asset $ 1,117 Liabilities Current portion of operating lease liabilities $ 349 Operating lease liabilities 936 Total operating lease liabilities $ 1,285 |
Future Minimum Commitments Due Under Non-Cancelable Operating Leases | Minimum lease payments were as follows at December 31, 2022 (in thousands): Year ending December 31, 2023 $ 362 2024 378 2025 389 2026 367 Total minimum lease payments 1,496 Less imputed interest ( 211 ) Total operating lease liabilities $ 1,285 |
Net Income (Loss) Per Share (Ta
Net Income (Loss) Per Share (Tables) | 12 Months Ended |
Dec. 31, 2022 | |
Earnings Per Share [Abstract] | |
Schedule of Earnings Per Share, Basic and Diluted | Therefore, the denominator used to calculate both basic and diluted net loss per share is the same in all periods presented. Year Ended December 31, 2022 2021 2020 Net (loss) income - basic and diluted $ ( 32,947 ) $ 376 $ ( 18,210 ) Weighted average shares - basic 60,204,862 58,491,986 46,506,540 Effect of dilutive securities: Stock options — 1,058,134 — Restricted stock — 342,943 — ESPP — 13,539 — Weighted average shares - diluted 60,204,862 59,906,602 46,506,540 Net (loss) income per share - basic $ ( 0.55 ) $ 0.01 $ ( 0.39 ) Net (loss) income per share - diluted $ ( 0.55 ) $ 0.01 $ ( 0.39 ) |
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 income (loss) per share for all periods presented because of their antidilutive effect consisted of the following: Year Ended 2022 2021 2020 Outstanding stock options 6,915,330 4,704,194 4,248,193 Non-vested restricted stock units 1,462,932 974,404 767,271 Stock purchase warrants 29,796 29,796 29,796 8,408,058 5,708,394 5,045,260 |
The Company - Additional Inform
The Company - Additional Information (Details) - USD ($) | 1 Months Ended | 2 Months Ended | 12 Months Ended | |||||||
Jan. 11, 2021 | Jan. 06, 2021 | Jan. 31, 2022 | Apr. 30, 2020 | Mar. 10, 2023 | Mar. 08, 2023 | Dec. 31, 2022 | Dec. 31, 2021 | Dec. 31, 2020 | Sep. 30, 2021 | |
Entity incorporation date | May 26, 2011 | |||||||||
Cash and cash equivalents | $ 48,258,000 | $ 30,436,000 | $ 17,287,000 | |||||||
Initial payment | 32,100,000 | |||||||||
Initial proceeds from royalty purchase and sale agreement | 32,500,000 | |||||||||
Royalty purchased | 1,862,000 | |||||||||
Proceeds from royalty purchase and sale agreement | (30,638,000) | $ 0 | 0 | |||||||
Interest expense on borrowings | $ 147,000 | |||||||||
Royalty Purchase And Sale Agreement | ||||||||||
Royalty purchased | 1,500,000 | |||||||||
Proceeds from royalty purchase and sale agreement | $ 30,600,000 | |||||||||
PPP Loan [Member] | ||||||||||
Proceeds from Loan | $ 1,000,000 | |||||||||
Interest expense on borrowings | $ 7,000 | |||||||||
Arctic Vision Limited | License Arrangement | ||||||||||
Consideration received from expansion of business | $ 3,000,000 | |||||||||
Bausch Health Ireland Limited | ||||||||||
Aggregate milestone payments from the licensees | $ 10,000,000 | |||||||||
Private Placement | Common Stock | ||||||||||
Purchase of common stock by institutional purchasers | 4,200,000 | |||||||||
Purchase price per share | $ 2.851 | |||||||||
Net proceeds after deducting offering expenses | $ 11,100,000 | |||||||||
At-the-market Sales Agreement | Cowen and Company LLC | Common Stock | ||||||||||
Number of shares sold under facility | 425,460 | 2,900,000 | ||||||||
Net proceeds from issuance of stock | $ 600,000 | $ 12,200,000 | ||||||||
At-the-market Sales Agreement | Cowen and Company LLC | Common Stock | Subsequent Event | ||||||||||
Number of shares sold under facility | 214,128 | |||||||||
Net Proceeds From Issuance Of Stocks | $ 300,000 |
Significant Accounting Polici_3
Significant Accounting Policies - Additional Information (Detail) | 12 Months Ended | |||
Dec. 31, 2022 USD ($) NumberOfSegment | Dec. 31, 2021 USD ($) | Dec. 31, 2020 USD ($) | Oct. 31, 2021 USD ($) | |
Number of operating segments | NumberOfSegment | 1 | |||
Revenue | $ 1,327,000 | $ 29,575,000 | $ 7,894,000 | |
Deferred revenue | 205,000 | 0 | ||
Bausch | ||||
Milestone Payments Received | 5,000,000 | |||
Pre-launch milestone payments | 10,000,000 | |||
Bausch | Upfront Payment | ||||
Deferred revenue | 5,000 | $ 5,000,000 | ||
Arctic Vision Limited | ||||
Milestone Payments Received | 4,300,000 | |||
REGENXBIO | ||||
Milestone Payments Received | 3,000,000 | |||
License [Member] | ||||
Revenue | $ 1,300,000 | 29,600,000 | $ 7,700,000 | |
License [Member] | Arctic Vision Limited | ||||
Consideration received for territory expansion | $ 8,000,000 |
Property and Equipment, Net - S
Property and Equipment, Net - Schedule of Property and Equipment, Net (Details) - USD ($) $ in Thousands | 12 Months Ended | |
Dec. 31, 2022 | Dec. 31, 2021 | |
Property Plant And Equipment [Line Items] | ||
Total property and equipment | $ 1,608 | $ 1,193 |
Less: Accumulated depreciation | (853) | (955) |
Property and equipment, net | 755 | 238 |
Furniture and Fixtures | ||
Property Plant And Equipment [Line Items] | ||
Total property and equipment | $ 249 | 337 |
Estimated Useful Lives (Years) | 5 years | |
Machinery and Equipment | ||
Property Plant And Equipment [Line Items] | ||
Total property and equipment | $ 343 | 176 |
Estimated Useful Lives (Years) | 5 years | |
Computer Equipment | ||
Property Plant And Equipment [Line Items] | ||
Total property and equipment | $ 13 | 13 |
Estimated Useful Lives (Years) | 3 years | |
Leasehold Improvements | ||
Property Plant And Equipment [Line Items] | ||
Total property and equipment | $ 476 | 667 |
Estimated Useful Lives (Years) | Lesser ofuseful life orremaininglease term | |
Work in process | ||
Property Plant And Equipment [Line Items] | ||
Total property and equipment | $ 527 | $ 0 |
Accrued Liabilities - Schedule
Accrued Liabilities - Schedule of Accrued Liabilities (Details) - USD ($) $ in Thousands | Dec. 31, 2022 | Dec. 31, 2021 |
Payables and Accruals [Abstract] | ||
Accrued research and development | $ 1,817 | $ 1,083 |
Accrued employee costs | 1,837 | 1,854 |
Accrued professional fees | 49 | 30 |
Accrued expense | 476 | 345 |
Accrued liabilities, current | $ 4,179 | $ 3,312 |
Royalty Purchase and Sale Agr_3
Royalty Purchase and Sale Agreement (Additional Information) (Details) - USD ($) $ in Thousands | 12 Months Ended | |||
Aug. 08, 2022 | Dec. 31, 2022 | Dec. 31, 2021 | Dec. 31, 2020 | |
Research and Development Arrangement, Contract to Perform for Others [Line Items] | ||||
Initial proceeds from royalty purchase and sales agreement | $ 32,500 | |||
Purchase and sale agreement description | The Purchase and Sale Agreement will automatically expire, and the payment of Royalties from the Royalty Sub to HCR will cease, when HCR has received payments of the Royalties equal to 2.5 times the aggregate amount of payments made by HCR under the Agreement if the Second Milestone Event is achieved on or prior to December 31, 2024 (the “Initial Cap”). If the Second Milestone Event is not achieved on or prior to December 31, 2024, payment of Royalties from Royalty Sub to HCR will cease when HCR has received Royalties payments equal to 3.4 times the aggregate amount of payments under the Purchase and Sale Agreement (the “Alternative Cap”, and together with the Initial Cap, the “Cap Amount”). In the event of a change in control, acquiror will have the option to make a payment to HCR of the Cap Amount then in effect, less the aggregate amount of Royalty payments made by Royalty Sub to HCR under the Purchase and Sale Agreement as a one-time payment at which time, payment of Royalties to HCR will cease. Alternatively, in the event of a change in control, the acquiror will have the option to make an initial payment of 1.0 times the aggregate amount of payments made by HCR under the Purchase and Sale Agreement as of the date of such change in control, then in that event, payment of Royalties from Royalty Sub to HCR will cease when HCR has received total Royalties payments (including the initial payment) equal to the Alternative Cap. After the Purchase and Sale Agreement expires, all rights to receive the Royalties return to Royalty Sub. | |||
Debt related commitment fees and debt related issuance costs | $ 1,900 | |||
Issuance costs | 1,862 | |||
Proceeds from royalty purchase and sale agreement, net of issuance costs | (30,638) | $ 0 | $ 0 | |
Royalty Purchase and Sale Agreement [Member] | ||||
Research and Development Arrangement, Contract to Perform for Others [Line Items] | ||||
Issuance costs | 1,500 | |||
Proceeds from royalty purchase and sale agreement, net of issuance costs | $ 30,600 | |||
Royalty Purchase and Sale Agreement [Member] | Royalty Sub Member [Member] | ||||
Research and Development Arrangement, Contract to Perform for Others [Line Items] | ||||
Initial proceeds from royalty purchase and sales agreement net of certain expenses | $ 32,100 | |||
First Milestone Proceeds From Royalty Purchase And Sale Agreement | 12,500 | |||
Second Milestone Proceeds From Royalty Purchase And Sale Agreement | 20,000 | |||
Royalty Purchase and Sale Agreement [Member] | Royalty Sub Member [Member] | Maximum [Member] | ||||
Research and Development Arrangement, Contract to Perform for Others [Line Items] | ||||
Maximum proceeds from royalty purchase and sale agreement | $ 65,000 |
Royalty Purchase and Sale Agr_4
Royalty Purchase and Sale Agreement - Schedule of activity of the royalty obligation (Details) - USD ($) $ in Thousands | 12 Months Ended | ||
Dec. 31, 2022 | Dec. 31, 2021 | Dec. 31, 2020 | |
Royalty Obligation [Abstract] | |||
Royalty purchase and sale agreement effective August 8, 2022 | $ 32,500 | ||
Issuance costs | (1,862) | ||
Non-cash interest expense | 3,339 | $ 0 | $ 0 |
Balance at December 31, 2022 | $ 33,977 | $ 0 | |
Effective interest rate | 26.50% |
Long-Term Debt - Additional Inf
Long-Term Debt - Additional Information (Details) - USD ($) | 12 Months Ended | ||||
May 07, 2020 | Oct. 18, 2019 | May 14, 2018 | Dec. 31, 2022 | Dec. 31, 2020 | |
Debt Instrument [Line Items] | |||||
Interest expense on borrowings | $ 147,000 | ||||
Accretion of scheduled final payment | 59,000 | ||||
Accretion of deferred closing costs | $ 129,000 | ||||
Second Amended and Restated Loan and Security Agreement | |||||
Debt Instrument [Line Items] | |||||
Debt instrument, principal balance payment | $ 5,000,000 | ||||
Debt Instrument, Final Payment, Interest | $ 300,000 | ||||
Third Amended And Restated Loan And Security Agreement | |||||
Debt Instrument [Line Items] | |||||
Debt instrument, payment terms | On October 18, 2019, the Company entered into an amendment to the 2nd A&R Loan Agreement with the Lenders. Pursuant to the amendment, the Company repaid $5.0 million of the outstanding principal balance of the $10.0 million term loan. The Company did not pay any final payment or termination fees in connection with the $5.0 million prepayment. In addition, the Company and the Lenders agreed to modify the term loan repayment schedule. As amended, the term loan repayment schedule provided for interest only payments through October 31, 2020, followed by consecutive equal monthly payments of principal and interest in arrears continuing through the maturity date of October 1, 2022 | ||||
Silicon Valley Bank, MidCap Funding III Trust and MidCap Financial Trust | Second Amended and Restated Loan and Security Agreement | |||||
Debt Instrument [Line Items] | |||||
Fixed interest rate | 6.50% | ||||
Variable interest rate | 1.89% | ||||
Debt instrument, description of variable rate basis | 30-day U.S. LIBOR | ||||
Line of credit facility, maximum borrowing capacity | $ 20,000,000 | ||||
Long term debt | 10,000,000 | ||||
Line of credit facility, remaining borrowing capacity description | Of the remaining $10.0 million available under the 2nd A&R loan agreement, the Company elected not to draw $5.0 million and the other $5.0 million was not available for draw | ||||
Line of credit facility remaining borrowing capacity not available for withdraw | 5,000,000 | ||||
Line of credit facility, remaining borrowing capacity | 5,000,000 | ||||
Silicon Valley Bank, MidCap Funding III Trust and MidCap Financial Trust | Second Amended and Restated Loan and Security Agreement, Initial Tranche | |||||
Debt Instrument [Line Items] | |||||
Long term debt | 10,000,000 | ||||
Silicon Valley Bank , MidCap Funding XII Trust and MidCap Financial Trust | First Amended and Restated Loan and Security Agreement | Final Payment | |||||
Debt Instrument [Line Items] | |||||
Repayment of outstanding amount under the loan agreement including fees | $ 7,000,000 | ||||
Silicon Valley Bank , MidCap Funding XII Trust and MidCap Financial Trust | Third Amended And Restated Loan And Security Agreement | |||||
Debt Instrument [Line Items] | |||||
Long term debt | $ 10,000,000 | ||||
Repayment of outstanding amount under the loan agreement including fees | $ 5,000,000 | ||||
Loans held-for-sale, maturity date | Oct. 01, 2022 | ||||
Final payment during maturity, percentage | 5.50% |
CARES Act Paycheck Protection_2
CARES Act Paycheck Protection Program Loan - Additional Information (Details) - USD ($) | 1 Months Ended | 12 Months Ended | |
Jan. 11, 2021 | Apr. 20, 2020 | Dec. 31, 2020 | |
Short Term Debt [Line Items] | |||
Interest expense on borrowings | $ 147,000 | ||
PPP Loan | |||
Short Term Debt [Line Items] | |||
Interest expense on borrowings | $ 7,000 | ||
PPP Loan | Silicon Valley Bank | |||
Short Term Debt [Line Items] | |||
Aggregate principal amount | $ 1,000,000 | ||
Interest rate on outstanding principal amount | 1% | ||
Note, Maturity date | Apr. 30, 2022 |
Preferred and Common Stock - Ad
Preferred and Common Stock - Additional Information (Detail) - $ / shares | Dec. 31, 2022 | Jun. 22, 2022 | Dec. 31, 2021 |
Preferred stock, shares authorized | 10,000,000 | 10,000,000 | |
Preferred stock, par value | $ 0.001 | $ 0.001 | |
Preferred stock, shares issued | 0 | 0 | |
Preferred stock, shares outstanding | 0 | 0 | |
Common stock, shares authorized | 200,000,000 | 100,000,000 | 100,000,000 |
Common stock, par value | $ 0.001 | $ 0.001 | |
Common stock, shares outstanding | 60,639,827 | 59,722,930 | |
Maximum [Member] | |||
Common stock, shares authorized | 200,000,000 |
Common Stock Warrants - Additio
Common Stock Warrants - Additional Information (Details) - $ / shares | 1 Months Ended | 12 Months Ended |
Sep. 30, 2016 | Dec. 31, 2022 | |
Class Of Warrant Or Right [Line Items] | ||
Weighted average remaining life of warrants | 3 years 9 months | |
Maximum [Member] | ||
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 |
Share-Based Compensation - Addi
Share-Based Compensation - Additional Information (Details) - USD ($) $ / shares in Units, $ in Millions | 12 Months Ended | ||||
Jan. 01, 2022 | Jan. 31, 2016 | Dec. 31, 2022 | Dec. 31, 2021 | Dec. 31, 2020 | |
2016 Stock Incentive Plan | |||||
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | |||||
Annual increase of common stock reserved for issuance | 4% | ||||
Increase in common stock for future issuance, shares | 2,425,593 | ||||
Shares common stock reserved for issuance | 3,460,967 | ||||
2016 Employee Stock Purchase Plan | |||||
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | |||||
Share based compensation arrangement description | The number of shares reserved for issuance under the 2016 ESPP will automatically increase on January 1 of each year, through January 1, 2026, by the lesser of (i) 1% of the total number of shares of the Company’s common stock outstanding on December 31 of the preceding calendar year, (ii) 454,545 shares of common stock or (iii) a lesser number of shares as may be determined by the Company’s board of directors | ||||
Shares common stock reserved for issuance | 438,572 | ||||
Employee payroll deductions, percent | 15% | ||||
Addition of common stock shares reserved for future issuance | 454,545 | ||||
Issuance of common shares under employee stock purchase plan, shares | 66,919 | 65,481 | 35,359 | ||
Stock Options | |||||
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | |||||
Option to purchase common stock shares outstanding | 6,915,330 | ||||
Weighted average exercise price | $ 3.58 | ||||
Unrecognized compensation expense related to unvested stock options | $ 4.4 | ||||
Expected to be recognized over a weighted average period | 2 years 3 months 18 days | ||||
Weighted-average fair values granted | $ 1.55 | $ 3.24 | $ 1.97 | ||
Fair market value per share of common stock | $ 1.12 | ||||
Stock Options | 2016 Stock Incentive Plan | |||||
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | |||||
Share based compensation arrangement description | The number of shares of common stock reserved for issuance under the 2016 Plan will automatically increase on January 1 each year, through January 1, 2026, by 4% of the total number of shares of the Company’s common stock outstanding on December 31 of the preceding calendar year, or a lesser number of shares as may be determined by the Company’s board of directors. | ||||
Annual increase of common stock reserved for issuance | 4% | ||||
Option to purchase common stock shares outstanding | 6,590,838 | ||||
Weighted average exercise price | $ 3.59 | ||||
Shares available for future grant | 1,035,374 | ||||
Stock Options | 2011 Stock Incentive Plan | |||||
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | |||||
Number of shares grants | 0 | ||||
Option to purchase common stock shares outstanding | 307,256 | ||||
Weighted average exercise price | $ 3.26 | ||||
Restricted Stock Units (RSUs) | |||||
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | |||||
Expected to be recognized over a weighted average period | 2 years 3 months 18 days | ||||
Unrecognized compensation expense related to the RSUs | $ 3.1 |
Share-Based Compensation - Summ
Share-Based Compensation - Summary of Share-based Compensation Expense (Details) - USD ($) $ in Thousands | 12 Months Ended | ||
Dec. 31, 2022 | Dec. 31, 2021 | Dec. 31, 2020 | |
2016 Employee Stock Purchase Plan | |||
Employee Service Share Based Compensation Allocation Of Recognized Period Costs [Line Items] | |||
Share-based compensation expense | $ 31 | $ 61 | $ 41 |
2016 Employee Stock Purchase Plan | Research and Development | |||
Employee Service Share Based Compensation Allocation Of Recognized Period Costs [Line Items] | |||
Share-based compensation expense | 21 | 41 | 19 |
2016 Employee Stock Purchase Plan | General and Administrative | |||
Employee Service Share Based Compensation Allocation Of Recognized Period Costs [Line Items] | |||
Share-based compensation expense | 10 | 20 | 22 |
Stock Options | 2016 Equity Incentive Plan | |||
Employee Service Share Based Compensation Allocation Of Recognized Period Costs [Line Items] | |||
Share-based compensation expense | 3,401 | 3,555 | 2,757 |
Stock Options | 2016 Equity Incentive Plan | Research and Development | |||
Employee Service Share Based Compensation Allocation Of Recognized Period Costs [Line Items] | |||
Share-based compensation expense | 1,616 | 1,570 | 1,183 |
Stock Options | 2016 Equity Incentive Plan | General and Administrative | |||
Employee Service Share Based Compensation Allocation Of Recognized Period Costs [Line Items] | |||
Share-based compensation expense | 1,785 | 1,985 | 1,574 |
Restricted Stock Units (RSUs) | |||
Employee Service Share Based Compensation Allocation Of Recognized Period Costs [Line Items] | |||
Share-based compensation expense | 1,452 | 1,438 | 802 |
Restricted Stock Units (RSUs) | Research and Development | |||
Employee Service Share Based Compensation Allocation Of Recognized Period Costs [Line Items] | |||
Share-based compensation expense | 794 | 723 | 375 |
Restricted Stock Units (RSUs) | General and Administrative | |||
Employee Service Share Based Compensation Allocation Of Recognized Period Costs [Line Items] | |||
Share-based compensation expense | $ 658 | $ 715 | $ 427 |
Share-Based Compensation - Weig
Share-Based Compensation - Weighted Average Assumptions Used in Black-Scholes Option Pricing Model to Calculate Fair Value of Underlying Common Stock (Details) - Stock Options | 12 Months Ended | ||
Dec. 31, 2022 | Dec. 31, 2021 | Dec. 31, 2020 | |
Employee Service Share Based Compensation Allocation Of Recognized Period Costs [Line Items] | |||
Expected term (years) | 6 years | 7 years | 7 years |
Expected stock price volatility | 98.24% | 101.43% | 108.13% |
Risk-free interest rate | 2.09% | 0.75% | 1.52% |
Expected dividend yield | 0% | 0% | 0% |
Share-Based Compensation - Su_2
Share-Based Compensation - Summary of Activity Related to Stock Options (Details) - Stock Options - $ / shares | 12 Months Ended | |
Dec. 31, 2022 | Dec. 31, 2021 | |
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | ||
Number of Shares, Options outstanding, Ending balance | 6,915,330 | |
Number of Shares, Options exercisable | 4,223,931 | |
Weighted Average Exercise Price, Options outstanding, Ending balance | $ 3.58 | |
Weighted Average Exercise Price, Options exercisable | $ 4.22 | |
2011 Stock Incentive Plan, 2016 Equity Incentive Plan | ||
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | ||
Number of Shares, Options outstanding, Beginning balance | 5,762,328 | |
Number of Shares, Granted | 1,782,440 | |
Number of Shares, Exercised | (49,187) | |
Number of Shares, Cancelled/Forfeited | (580,251) | |
Number of Shares, Options outstanding, Ending balance | 6,915,330 | 5,762,328 |
Number of Shares, Options exercisable | 4,223,931 | 3,148,502 |
Weighted Average Exercise Price, Options outstanding, Beginning balance | $ 4.07 | |
Weighted Average Exercise Price, Granted | 1.98 | |
Weighted Average Exercise Price, Exercised | 0.35 | |
Weighted Average Exercise Price, Cancelled/Forfeited | 3.73 | |
Weighted Average Exercise Price, Options outstanding, Ending balance | 3.58 | $ 4.07 |
Weighted Average Exercise Price, Options exercisable | $ 4.22 | $ 4.59 |
Share-Based Compensation - Ad_2
Share-Based Compensation - Additional Information about the Stock Option Outstanding and Exercisable (Details) - Stock Options $ / shares in Units, $ in Thousands | 12 Months Ended |
Dec. 31, 2022 USD ($) $ / shares shares | |
Share-based Compensation, Shares Authorized under Stock Option Plans, Exercise Price Range [Line Items] | |
Options Outstanding | shares | 6,915,330 |
Weighted Average Exercise Price | $ / shares | $ 3.58 |
Aggregate Intrinsic Value | $ | $ 66 |
Weighted Average Remaining Contractual Life (Years) | 7 years 10 days |
Options Exercisable | shares | 4,223,931 |
Weighted Average Exercise Price | $ / shares | $ 4.22 |
Aggregate Intrinsic Value | $ | $ 64 |
Weighted Average Remaining Contractual Life (Years) | 6 years 7 days |
$0.00 - $2.99 | |
Share-based Compensation, Shares Authorized under Stock Option Plans, Exercise Price Range [Line Items] | |
Exercise Price Lower Range Limit | $ / shares | $ 0 |
Exercise Price Upper Range Limit | $ / shares | $ 2.99 |
Options Outstanding | shares | 3,777,873 |
Weighted Average Remaining Contractual Life (Years) | 7 years 7 months 9 days |
Options Exercisable | shares | 1,865,987 |
Weighted Average Remaining Contractual Life (Years) | 6 years 3 months 21 days |
$3.00 - $6.99 | |
Share-based Compensation, Shares Authorized under Stock Option Plans, Exercise Price Range [Line Items] | |
Exercise Price Lower Range Limit | $ / shares | $ 3 |
Exercise Price Upper Range Limit | $ / shares | $ 6.99 |
Options Outstanding | shares | 2,506,371 |
Weighted Average Remaining Contractual Life (Years) | 6 years 10 months 6 days |
Options Exercisable | shares | 1,726,858 |
Weighted Average Remaining Contractual Life (Years) | 6 years 3 months 18 days |
$7.00 - $8.99 | |
Share-based Compensation, Shares Authorized under Stock Option Plans, Exercise Price Range [Line Items] | |
Exercise Price Lower Range Limit | $ / shares | $ 7 |
Exercise Price Upper Range Limit | $ / shares | $ 8.99 |
Options Outstanding | shares | 429,308 |
Weighted Average Remaining Contractual Life (Years) | 4 years 2 months 1 day |
Options Exercisable | shares | 429,308 |
Weighted Average Remaining Contractual Life (Years) | 4 years 2 months 1 day |
$9.00 - $20.84 | |
Share-based Compensation, Shares Authorized under Stock Option Plans, Exercise Price Range [Line Items] | |
Exercise Price Lower Range Limit | $ / shares | $ 9 |
Exercise Price Upper Range Limit | $ / shares | $ 20.84 |
Options Outstanding | shares | 201,778 |
Weighted Average Remaining Contractual Life (Years) | 4 years 9 months 3 days |
Options Exercisable | shares | 201,778 |
Weighted Average Remaining Contractual Life (Years) | 4 years 9 months 3 days |
Share-Based Compensation - Su_3
Share-Based Compensation - Summary of the Activity Related to RSUs (Details) - Restricted Stock Units (RSUs) | 12 Months Ended |
Dec. 31, 2022 $ / shares shares | |
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | |
Non-vested units outstanding, Number of Shares, Beginning balance | shares | 1,317,347 |
Number of Shares, Granted | shares | 648,460 |
Number of Shares, Vested | shares | (375,331) |
Number of Shares, Forfeited | shares | (127,544) |
Non-vested units outstanding, Number of Shares, Ending balance | shares | 1,462,932 |
Non-vested units outstanding, Weighted Average Grant Date Fair Value, Beginning balance | $ / shares | $ 3.58 |
Weighted Average Grant Date Fair Value, Granted | $ / shares | 2.19 |
Weighted Average Grant Date Fair Value, Vested | $ / shares | 3.44 |
Weighted Average Grant Date Fair Value, Forfeited | $ / shares | 3.04 |
Non-vested units outstanding, Weighted Average Grant Date Fair Value, Ending balance | $ / shares | $ 3.04 |
Income Taxes - Schedule of Net
Income Taxes - Schedule of Net Deferred Tax Assets (Detail) - USD ($) $ in Thousands | Dec. 31, 2022 | Dec. 31, 2021 | Dec. 31, 2020 |
Deferred tax asset (liability) | |||
Net operating loss carryforwards | $ 50,267 | $ 53,966 | $ 51,414 |
Non-deductible accrued expenses | 386 | 469 | 263 |
Right-of-use asset | (238) | (96) | (132) |
Lease liability | 274 | 176 | 247 |
Deferred revenue | 0 | 0 | 1,247 |
Stock compensation expense | 2,678 | 2,768 | 2,044 |
Depreciation differences | (40) | (44) | (82) |
Disallowed interest expense | 0 | 0 | 7 |
Charitable contributions | 0 | 6 | 0 |
Royalty Purchases And Sale Agreement | 7,247 | 0 | 0 |
Capitalized research and development expenses | 3,057 | 0 | 0 |
Valuation allowance | (73,699) | (66,599) | (63,404) |
Net deferred tax asset | 0 | 0 | 0 |
Federal | |||
Deferred tax asset (liability) | |||
Net operating loss carryforwards | 45,400 | ||
Tax credits | 9,742 | 9,012 | 8,015 |
State | |||
Deferred tax asset (liability) | |||
Net operating loss carryforwards | 4,900 | ||
Tax credits | $ 326 | $ 342 | $ 381 |
Income Taxes - Schedule of Stat
Income Taxes - Schedule of Statutory and Effective Income Tax Rate Reconciliation (Detail) | 12 Months Ended | ||
Dec. 31, 2022 | Dec. 31, 2021 | Dec. 31, 2020 | |
Income Tax Disclosure [Abstract] | |||
U.S. federal tax rate | 21% | 21% | 21% |
State tax rate | (0.85%) | (599.32%) | 14.28% |
Permanent difference | (1.34%) | (3.15%) | 1.42% |
Tax credit | 2.18% | (253.97%) | 2.89% |
Valuation allowance | (21.57%) | 847.82% | (39.66%) |
ASC 740-10 | 0% | (3.19%) | (0.26%) |
Adjustment to prior year tax provision | 0.67% | (13.16%) | 0% |
Other | (0.09%) | 3.97% | 0% |
Total income tax provision (benefit) | 0% | 0% | (0.33%) |
Income Tax - Additional Informa
Income Tax - Additional Information (Detail) - USD ($) | 12 Months Ended | ||
Dec. 31, 2022 | Dec. 31, 2021 | Dec. 31, 2020 | |
Income Tax Disclosure [Line Items] | |||
Deferred tax assets, valuation allowance | $ 73,699,000 | $ 66,599,000 | $ 63,404,000 |
Deferred tax assets, net operating loss carryforwards | 50,267,000 | 53,966,000 | $ 51,414,000 |
Unrecognized tax benefits that would affect the effective tax rate if recognized | 7,500,000 | $ 7,500,000 | |
Unrecognized tax expenses | 48,000 | ||
Unrecognized tax benefits, income tax penalties expense | $ 0 | ||
Operating loss carryforwards, limitations on use | Ownership changes, as defined by Section 382 of the Internal Revenue Code of 1986, as amended (the “Code”), may limit the amount of net operating losses that a company may utilize to offset future taxable income and taxes payable. In general, if the Company experiences a greater than 50% aggregate change in ownership over a 3-year period (a Section 382 ownership change), utilization of the Company’s pre-change NOL carryforwards may be subject to limitation under the Code. The annual limitation generally is determined by multiplying the value of the Company’s stock at the time of such ownership change (subject to certain adjustments) by the applicable long-term tax-exempt rate for the month in which the ownership change occurred. Such limitation may result in expiration of a portion of the NOL carryforwards before utilization. The Company has completed an owner shift analysis to determine the dates in which the Company may have experienced a Section 382 ownership change, and determined that the Company experienced ownership changes for Section 382 purposes in January 2012, December 2013, and July 2016. | ||
Deferred tax Federal Net Operating Carry forward | $ 38,000 | ||
Deferred tax Federal Research and Development credit | 2,000 | ||
Federal | |||
Income Tax Disclosure [Line Items] | |||
Net operating loss carryforwards | 216,100,000 | ||
Deferred tax assets, net operating loss carryforwards | $ 45,400,000 | ||
Federal | Earliest Tax Year | |||
Income Tax Disclosure [Line Items] | |||
Operating loss carryforwards expiration period | 2031 | ||
State | |||
Income Tax Disclosure [Line Items] | |||
Net operating loss carryforwards | $ 78,400,000 | ||
Deferred tax assets, net operating loss carryforwards | $ 4,900,000 | ||
State | Earliest Tax Year | |||
Income Tax Disclosure [Line Items] | |||
Operating loss carryforwards expiration period | 2027 |
Summary of Activity Related to
Summary of Activity Related to Uncertain Tax Positions (Detail) - USD ($) $ in Thousands | 12 Months Ended | |
Dec. 31, 2022 | Dec. 31, 2021 | |
Summary of activity related to uncertain tax positions | ||
Balance of uncertain tax positions at the beginning of the year | $ 7,520 | $ 7,568 |
Gross decreases - tax positions in prior period | 0 | (12) |
Gross decreases - settlements with taxing authorities | 0 | (36) |
Balance of uncertain tax positions at the end of the year | $ 7,520 | $ 7,520 |
Commitment and Contingencies -
Commitment and Contingencies - Additional Information (Details) | 1 Months Ended | 12 Months Ended | ||||
Nov. 30, 2022 USD ($) ft² | May 31, 2018 | Nov. 30, 2016 USD ($) ft² | Dec. 31, 2022 USD ($) | Dec. 31, 2021 USD ($) | Dec. 31, 2020 USD ($) | |
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 is not reasonably certain if the Alpharetta, Georgia lease will be renewed. | |||||
Incremental borrowing rate | 8% | |||||
Operating lease, remaining lease term | 4 years | |||||
Operating Lease, Cost | $ 262,000 | $ 247,000 | $ 247,000 | |||
Variable Lease, Cost | 87,000 | 95,000 | 95,000 | |||
Short-term Lease, Cost | 86,000 | 12,000 | 20,000 | |||
Operating lease liabilities | $ 339,000 | $ 392,000 | $ 378,000 | |||
Manufacturing Supply Agreement | Gerresheimer Regensburg GmbH | ||||||
Commitment And Contingencies [Line Items] | ||||||
Initial term of agreement | 5 years | |||||
Renewal term of agreement | 3 years | |||||
GEORGIA | ||||||
Commitment And Contingencies [Line Items] | ||||||
Area of office leased | ft² | 14,000 | 20,000 | ||||
Operating lease agreement term | 4 years | 6 years 6 months | ||||
Operating lease agreement renewal option term | 38 months | 5 years | ||||
Minimum monthly lease payments | $ 30,437 | $ 35,145 | ||||
Percentage of increase per year | 3% | 3% |
Commitment and Contingencies _2
Commitment and Contingencies - Operating Leases Included on the Balance Sheet (Details) - USD ($) $ in Thousands | Dec. 31, 2022 | Dec. 31, 2021 |
Commitments and Contingencies Disclosure [Abstract] | ||
Operating lease right-of-use asset | $ 1,117 | $ 369 |
Liabilities | ||
Current portion of operating lease liabilities | 349 | 387 |
Operating lease liabilities | 936 | $ 288 |
Total operating lease liabilities | $ 1,285 |
Commitment and Contingencies _3
Commitment and Contingencies - Future Minimum Commitments Due Under Non-Cancelable Operating Leases (Details) $ in Thousands | Dec. 31, 2022 USD ($) |
Commitments and Contingencies Disclosure [Abstract] | |
2023 | $ 362 |
2024 | 378 |
2025 | 389 |
2026 | 367 |
Operating Leases Future Minimum Payment Due, Total | 1,496 |
Less imputed interest | (211) |
Total operating lease liabilities | $ 1,285 |
License and Other Agreements -
License and Other Agreements - Additional Information (Detail) - USD ($) | 1 Months Ended | 3 Months Ended | 12 Months Ended | ||||||||
Mar. 10, 2020 | Oct. 22, 2019 | Dec. 31, 2021 | Sep. 30, 2021 | Sep. 30, 2020 | Oct. 31, 2019 | Dec. 31, 2021 | Dec. 31, 2022 | Dec. 31, 2021 | Dec. 31, 2020 | Oct. 31, 2021 | |
Research And Development Arrangement Contract To Perform For Others [Line Items] | |||||||||||
Deferred revenue | $ 0 | $ 0 | $ 205,000 | $ 0 | |||||||
Revenue | 1,327,000 | 29,575,000 | $ 7,894,000 | ||||||||
Other Agreement | |||||||||||
Research And Development Arrangement Contract To Perform For Others [Line Items] | |||||||||||
Revenue | 13,000 | 200,000 | $ 105,000 | ||||||||
License Arrangement | REGENXBIO, Inc. | |||||||||||
Research And Development Arrangement Contract To Perform For Others [Line Items] | |||||||||||
Option fee paid | $ 2,000,000 | ||||||||||
Proceeds from option fee previously received | 500,000 | ||||||||||
Milestone payments | 31,000,000 | ||||||||||
Sales-based milestone payments | $ 102,000,000 | ||||||||||
Milestone payments received | $ 3,000,000 | ||||||||||
Bausch Health Ireland Limited | |||||||||||
Research And Development Arrangement Contract To Perform For Others [Line Items] | |||||||||||
Upfront payment | $ 5,000,000 | ||||||||||
Pre-launch milestone payments | 10,000,000 | ||||||||||
Milestone payments received | 5,000,000 | ||||||||||
Bausch Health Ireland Limited | Upfront Payment | |||||||||||
Research And Development Arrangement Contract To Perform For Others [Line Items] | |||||||||||
Deferred revenue | 5,000 | 5,000 | 5,000 | $ 5,000,000 | |||||||
Bausch Health Ireland Limited | XIPERE [Member] | |||||||||||
Research And Development Arrangement Contract To Perform For Others [Line Items] | |||||||||||
Pre-launch milestone payments | $ 10,000,000 | ||||||||||
First cumulative net sales of products | $ 45,000 | ||||||||||
Revenue | $ 5,000,000 | ||||||||||
Bausch Health Ireland Limited | XIPERE [Member] | Maximum [Member] | |||||||||||
Research And Development Arrangement Contract To Perform For Others [Line Items] | |||||||||||
Additional milestone payments | $ 55,000,000 | ||||||||||
Arctic Vision Limited | Maximum [Member] | |||||||||||
Research And Development Arrangement Contract To Perform For Others [Line Items] | |||||||||||
Threshold percentage of sales for tiered royalties | 12% | ||||||||||
Arctic Vision Limited | Minimum [Member] | |||||||||||
Research And Development Arrangement Contract To Perform For Others [Line Items] | |||||||||||
Threshold percentage of sales for tiered royalties | 10% | ||||||||||
Arctic Vision Limited | License Arrangement | |||||||||||
Research And Development Arrangement Contract To Perform For Others [Line Items] | |||||||||||
Consideration received for territory expansion | $ 3,000,000 | ||||||||||
Arctic Vision Limited | License Arrangement | Upfront Payment | |||||||||||
Research And Development Arrangement Contract To Perform For Others [Line Items] | |||||||||||
Upfront payment | $ 4,000,000 | ||||||||||
Arctic Vision Limited | License Arrangement | Maximum [Member] | |||||||||||
Research And Development Arrangement Contract To Perform For Others [Line Items] | |||||||||||
Development milestone payments | $ 22,500,000 | ||||||||||
Arctic Vision Limited | XIPERE [Member] | |||||||||||
Research And Development Arrangement Contract To Perform For Others [Line Items] | |||||||||||
Milestone payments | $ 4,000,000 |
Fair Value Measurements - Addit
Fair Value Measurements - Additional Information (Details) - USD ($) | Dec. 31, 2022 | Dec. 31, 2021 |
Fair Value Disclosures [Abstract] | ||
Significant transfers between Levels 1, 2 and 3 | $ 0 | $ 0 |
Net Income (Loss) Per Share - S
Net Income (Loss) Per Share - Schedule of Earnings Per Share, Basic and Diluted (Details) - USD ($) $ / shares in Units, $ in Thousands | 12 Months Ended | ||
Dec. 31, 2022 | Dec. 31, 2021 | Dec. 31, 2020 | |
Share-Based Compensation Arrangement by Share-Based Payment Award [Line Items] | |||
Net income (loss) - basic and diluted | $ (32,947) | $ 376 | $ (18,210) |
Weighted average shares - basic | 60,204,862 | 58,491,986 | 46,506,540 |
Effect of dilutive securities: | |||
Weighted average shares outstanding - diluted | 60,204,862 | 59,906,602 | 46,506,540 |
Net (loss) income per share of common stock - basic | $ (0.55) | $ 0.01 | $ (0.39) |
Net (loss) income per share of common stock - diluted | $ (0.55) | $ 0.01 | $ (0.39) |
Stock Options [Member] | |||
Effect of dilutive securities: | |||
Weighted Average Number of Shares Outstanding, Diluted, Adjustment | 1,058,134 | ||
Restricted Stock [Member] | |||
Effect of dilutive securities: | |||
Weighted Average Number of Shares Outstanding, Diluted, Adjustment | 342,943 | ||
ESPP [Member] | |||
Effect of dilutive securities: | |||
Weighted Average Number of Shares Outstanding, Diluted, Adjustment | 13,539 |
Net Loss Per Share - Potential
Net Loss Per Share - Potential Common Stock Equivalents Excluded from Computation of Diluted Net Loss per Share (Details) - shares | 12 Months Ended | ||
Dec. 31, 2022 | Dec. 31, 2021 | Dec. 31, 2020 | |
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] | |||
Antidilutive securities excluded from computation of earnings per share | 8,408,058 | 5,708,394 | 5,045,260 |
Outstanding Stock Options | |||
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] | |||
Antidilutive securities excluded from computation of earnings per share | 6,915,330 | 4,704,194 | 4,248,193 |
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 | 1,462,932 | 974,404 | 767,271 |
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 |