Document and Entity Information
Document and Entity Information - shares | 3 Months Ended | |
Mar. 31, 2024 | May 08, 2024 | |
Cover [Abstract] | ||
Entity Registrant Name | Clearside Biomedical, Inc. | |
Amendment Flag | false | |
Document Period End Date | Mar. 31, 2024 | |
Document Fiscal Year Focus | 2024 | |
Document Fiscal Period Focus | Q1 | |
Trading Symbol | CLSD | |
Document Type | 10-Q | |
Entity Central Index Key | 0001539029 | |
Current Fiscal Year End Date | --12-31 | |
Entity Filer Category | Non-accelerated Filer | |
Entity Small Business | true | |
Entity Emerging Growth Company | false | |
Entity Interactive Data Current | Yes | |
Document Transition Report | false | |
Title of 12(b) Security | Common Stock, par value $0.001 per share | |
Security Exchange Name | NASDAQ | |
Entity Incorporation, State or Country Code | DE | |
Document Quarterly Report | true | |
Entity Common Stock, Shares Outstanding | 74,731,139 | |
Entity Shell Company | false | |
Entity Current Reporting Status | Yes | |
Entity File Number | 001-37783 | |
Entity Tax Identification Number | 45-2437375 | |
Entity Address, Address Line One | 900 North Point Parkway | |
Entity Address, Address Line Two | Suite 200 | |
Entity Address, City or Town | Alpharetta | |
Entity Address, State or Province | GA | |
Entity Address, Postal Zip Code | 30005 | |
City Area Code | 678 | |
Local Phone Number | 270-3631 |
Consolidated Balance Sheets
Consolidated Balance Sheets - USD ($) $ in Thousands | Mar. 31, 2024 | Dec. 31, 2023 |
Current assets: | ||
Cash and cash equivalents | $ 35,355 | $ 28,920 |
Accounts receivable | 0 | 170 |
Prepaid expenses | 567 | 722 |
Other current assets | 193 | 311 |
Total current assets | 36,115 | 30,123 |
Property and equipment, net | 3,194 | 2,996 |
Operating lease right-of-use asset | 803 | 869 |
Other assets | 30 | 30 |
Total assets | 40,142 | 34,018 |
Current liabilities: | ||
Accounts payable (includes $17 and $331 to a related party as of March 31, 2024 and December 31, 2023, respectively) | 1,363 | 2,205 |
Accrued liabilities (includes $198 and $215 to a related party as of March 31, 2024 and December 31, 2023, respectively) | 4,070 | 4,169 |
Current portion of operating lease liabilities | 367 | 364 |
Deferred revenue | 150 | 75 |
Total current liabilities | 5,950 | 6,813 |
Liability related to the sales of future royalties, net | 44,391 | 41,988 |
Warrant liabilities | 11,039 | 0 |
Operating lease liabilities | 572 | 649 |
Other non-current liabilities | 0 | 480 |
Total liabilities | 61,952 | 49,930 |
Commitments and contingencies | ||
Stockholders' (deficit) equity: | ||
Preferred stock, $0.001 par value; 10,000,000 shares authorized and no shares issued at March 31, 2024 and December 31, 2023 | 0 | 0 |
Common stock, $0.001 par value; 200,000,000 shares authorized at March 31, 2024 and December 31, 2023; 74,731,139 and 62,850,841 shares issued and outstanding at March 31, 2024 and December 31, 2023, respectively | 74 | 63 |
Additional paid-in capital | 310,802 | 304,948 |
Accumulated deficit | (332,686) | (320,923) |
Total stockholders' (deficit) equity | (21,810) | (15,912) |
Total liabilities and stockholders' (deficit) equity | $ 40,142 | $ 34,018 |
Consolidated Balance Sheets (Pa
Consolidated Balance Sheets (Parenthetical) - USD ($) $ in Thousands | Mar. 31, 2024 | Dec. 31, 2023 |
Statement of Financial Position [Abstract] | ||
Accounts payable | $ 17 | $ 331 |
Accrued liabilities | $ 198 | $ 215 |
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 | 200,000,000 |
Common stock, shares, issued | 74,731,139 | 62,850,841 |
Common stock, shares outstanding | 74,731,139 | 62,850,841 |
Consolidated Statements of Oper
Consolidated Statements of Operations (unaudited) - USD ($) $ in Thousands | 3 Months Ended | |
Mar. 31, 2024 | Mar. 31, 2023 | |
Income Statement [Abstract] | ||
License and other revenue (includes $75 from a related party for the three months ended March 31, 2024) | $ 230 | $ 4 |
Type of Revenue [Extensible List] | us-gaap:LicenseMember | us-gaap:LicenseMember |
Operating expenses: | ||
Research and development (includes $256 to a related party for the three months ended March 31, 2024) | $ 5,615 | $ 4,451 |
General and administrative | 2,824 | 3,158 |
Total operating expenses | 8,439 | 7,609 |
Loss from operations | (8,209) | (7,605) |
Interest income | 348 | 492 |
Other expense | (1,499) | 0 |
Non-cash interest expense on liability related to the sales of future royalties | (2,403) | (2,167) |
Net loss | $ (11,763) | $ (9,280) |
Net loss per share of common stock - basic | $ (0.17) | $ (0.15) |
Net loss per share of common stock - diluted | $ (0.17) | $ (0.15) |
Weighted average shares outstanding - basic | 69,853,227 | 61,169,486 |
Weighted average shares outstanding - diluted | 69,853,227 | 61,169,486 |
Consolidated Statements of Op_2
Consolidated Statements of Operations (unaudited) (Parenthetical) $ in Thousands | 3 Months Ended |
Mar. 31, 2024 USD ($) | |
Income Statement [Abstract] | |
License and other revenue from Related Party | $ 75 |
Research and development to Related Party | $ 256 |
Consolidated Statements of Stoc
Consolidated Statements of Stockholders (Deficit) Equity (unaudited) - USD ($) $ in Thousands | Total | Common Stock | Additional Paid-In-Capital | Accumulated Deficit |
Beginning balance at Dec. 31, 2022 | $ 10,607 | $ 61 | $ 298,984 | $ (288,438) |
Beginning balance, shares at Dec. 31, 2022 | 60,639,827 | |||
Issuance of common stock under at-the-market sales agreement | 295 | 295 | ||
Issuance of common stock under at-the-market sales agreement, shares | 214,128 | |||
Vesting and settlement of restricted stock units, shares | 471,390 | |||
Issuance of common shares under employee stock purchase plan | 37 | 37 | ||
Issuance of common shares under employee stock purchase plan, shares | 38,954 | |||
Share-based compensation expense | 1,041 | 1,041 | ||
Net Income (Loss) | (9,280) | (9,280) | ||
Ending balance at Mar. 31, 2023 | 2,700 | $ 61 | 300,357 | (297,718) |
Ending balance, shares at Mar. 31, 2023 | 61,364,299 | |||
Beginning balance at Dec. 31, 2023 | (15,912) | $ 63 | 304,948 | (320,923) |
Beginning balance, shares at Dec. 31, 2023 | 62,850,841 | |||
Issuance of common stock under registered direct offering | 4,320 | $ 11 | 4,309 | |
Issuance of common stock under registered direct offering, shares | 11,111,111 | |||
Issuance of common stock under at-the-market sales agreement | 450 | 450 | ||
Issuance of common stock under at-the-market sales agreement, shares | 339,912 | |||
Exercise of stock options | 12 | 12 | ||
Exercise of stock options, shares | 10,000 | |||
Vesting and settlement of restricted stock units, shares | 397,594 | |||
Issuance of common shares under employee stock purchase plan | 21 | 21 | ||
Issuance of common shares under employee stock purchase plan, shares | 21,681 | |||
Share-based compensation expense | 1,062 | 1,062 | ||
Net Income (Loss) | (11,763) | (11,763) | ||
Ending balance at Mar. 31, 2024 | $ (21,810) | $ 74 | $ 310,802 | $ (332,686) |
Ending balance, shares at Mar. 31, 2024 | 74,731,139 |
Consolidated Statements of Cash
Consolidated Statements of Cash Flows (unaudited) - USD ($) $ in Thousands | 3 Months Ended | |
Mar. 31, 2024 | Mar. 31, 2023 | |
Operating activities | ||
Net loss | $ (11,763) | $ (9,280) |
Adjustments to reconcile net loss to net cash used in operating activities: | ||
Non-cash interest expense on liability related to the sales of future royalties, net of issuance costs accretion | 2,403 | 2,167 |
Depreciation | 28 | 15 |
Share-based compensation expense | 1,062 | 1,041 |
Change in fair value of warrant liabilities | 712 | 0 |
Issuance costs allocated to warrant liabilities | 787 | 0 |
Changes in operating assets and liabilities: | ||
Prepaid expenses and other current assets | 443 | (165) |
Other assets and liabilities | (488) | (2) |
Accounts payable and accrued liabilities (includes $(310) to a related party for the three months ended March 31, 2024) | (1,110) | (1,067) |
Deferred revenue | 75 | 75 |
Net cash used in operating activities | (7,851) | (7,216) |
Investing activities | ||
Acquisition of property and equipment | (57) | (115) |
Net cash used in investing activities | (57) | (115) |
Financing activities | ||
Proceeds from issuance of comon stock and warrants under registered direct offering, net of issuance costs | 13,860 | 0 |
Proceeds from at-the-market sales agreement, net of issuance costs | 450 | 295 |
Proceeds from exercise of stock options | 12 | 0 |
Proceeds from shares issued under employee stock purchase plan | 21 | 37 |
Net cash provided by financing activities | 14,343 | 332 |
Net increase (decrease) in cash and cash equivalents | 6,435 | (6,999) |
Cash and cash equivalents, beginning of period | 28,920 | 48,418 |
Cash and cash equivalent, end of period | 35,355 | 41,419 |
Supplemental disclosure of noncash financing activities | ||
Purchase of property and equipment included in accrued liabilities | $ 163 | $ 186 |
Consolidated Statements of Ca_2
Consolidated Statements of Cash Flows (unaudited) (Parenthetical) $ in Thousands | 3 Months Ended |
Mar. 31, 2024 USD ($) | |
Accounts Payable And Accrued Liabilities To A Related party | $ (310) |
Pay vs Performance Disclosure
Pay vs Performance Disclosure - USD ($) $ in Thousands | 3 Months Ended | |
Mar. 31, 2024 | Mar. 31, 2023 | |
Pay vs Performance Disclosure | ||
Net Income (Loss) | $ (11,763) | $ (9,280) |
Insider Trading Arrangements
Insider Trading Arrangements | 3 Months Ended |
Mar. 31, 2024 | |
Trading Arrangements, by Individual | |
Rule 10b5-1 Arrangement Adopted | false |
Non-Rule 10b5-1 Arrangement Adopted | false |
Rule 10b5-1 Arrangement Terminated | false |
Non-Rule 10b5-1 Arrangement Terminated | false |
Rule 10b5-1 Arrangement Modified | false |
Non-Rule 10b5-1 Arrangement Modified | false |
The Company
The Company | 3 Months Ended |
Mar. 31, 2024 | |
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 $ 35.4 million as of March 31, 2024. 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 February 6, 2024, the Company entered into a securities purchase agreement with institutional investors and an existing stockholder, pursuant to which the Company issued and sold, in a registered direct offering (the “Registered Direct Offering”): (i) an aggregate of 11,111,111 shares of its common stock; and (ii) warrants to purchase up to 11,111,111 shares of common stock (the “Warrants”). The combined purchase price of each share and accompanying Warrant was $ 1.35 . The exercise price for the Warrants is $ 1.62 per share. The Warrants will be exercisable from August 9, 2024 and will expire on August 9, 2029 . The net proceeds to the Company from the Registered Direct Offering were $ 13.9 million. On January 31, 2024 (the “Amendment Effective Date”), the Company entered into a fourth amendment to the license agreement (as amended, the “Emory License Agreement”) with Emory University and Georgia Tech Research Corporation (collectively, the “Licensor”) pursuant to which the parties agreed to reduce the Sublicense Percentage (as defined in the Emory License Agreement) from a low double digit percentage to a high single digit percentage that the Company will pay the Licensor applicable to any fees or payments paid to the Company by any Sublicensee (as defined in the Emory License Agreement) of the Licensed Patents and/or Licensed Technology (each as defined in the Emory License Agreement), excluding (i) amounts paid to the Company by a Sublicensee to reimburse the Company for certain research and development costs pursuant to a written agreement between the Company and such Sublicensee, (ii) the value of intellectual property transferred or granted to the Company if necessary or helpful to the development or commercialization of Licensed Products (as defined in the Emory License Agreement) and (iii) amounts paid for shares of the Company’s stock. The payment to Licensor of any such Sublicense Percentage is due within 30 days of receipt by the Company of a qualifying payment from a Sublicensee, provided however, with respect to any qualifying payments received by the Company from a Sublicensee prior to January 1, 2025, the payment to Licensor of any such Sublicensee Percentage is due to Licensor by March 31, 2025. The parties also agreed to a revised annual license maintenance fee due each year (the “Maintenance Fee”) starting in 2023 through 2028, as follows: $ 250,000 for 2023 through 2025, $ 350,000 for 2026, $ 400,000 for 2027 and $ 500,000 for 2028. The Company paid the Maintenance Fee for 2023 in February 2024. The remaining annual Maintenance Fee payments are due on October 1st of each year. On December 22, 2023, Clearside Biomedical, Inc., through its wholly owned subsidiary Royalty Sub, entered into a letter agreement (the “Letter Agreement”) with HCR (as defined below) and HCR Clearside SPV, LLC (as assignee of HCR Collateral Management, LLC) (“Agent”) amending that certain Purchase and Sale Agreement, dated as of August 8, 2022, by and among Royalty Sub, HCR and Agent ("Purchase and Sale Agreement"). Pursuant to the terms of the Letter Agreement, Royalty Sub and Agent mutually agreed that Royalty Sub waived any and all rights to the $ 12.5 million milestone payment which was deposited in an escrow account (“First Milestone Payment") in connection with the closing of the transactions contemplated by the Purchase and Sale Agreement and agreed to the release of the First Milestone Payment to Agent. On November 1, 2023, the Company, entered into a license agreement (the “BioCryst License Agreement”) with BioCryst Pharmaceuticals, Inc. (“BioCryst”) pursuant to which the Company granted BioCryst an exclusive, worldwide and sublicensable license to the Company’s SCS Microinjector for the delivery of BioCryst’s proprietary plasma kallikrein inhibitor known as avoralstat for the treatment and prevention of diabetic macular edema (“DME”). The Company received an upfront license fee payment of $ 5.0 million in connection with signing of the BioCryst License Agreement. In addition, the Company is eligible to receive up to an additional $ 30.0 million in clinical and regulatory milestone payments, and up to a total of $ 47.5 million in a series of post-approval sales-based milestone payments based on the achievement of annual global net product sales milestones up to $ 2.0 billion. Further, during the royalty term, BioCryst has also agreed to pay the Company tiered mid-single digit royalties on annual global net product sales, with the highest royalty rate applied to sales over $ 1.5 billion, subject to reductions in specified circumstances. 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 as described in Note 5. In May 2023, the Company terminated its at-the-market sales agreement with Cowen and Company, LLC (the "ATM Agreement"). The Company sold 214,128 shares of its common stock for net proceeds of $ 0.3 million under its ATM Agreement with Cowen and Company, LLC d uring the three months ended March 31, 2023, prior to the termination of the ATM Agreement. In May 2023, the Company entered into a Controlled Equity Offering SM Sales Agreement (the "Sales Agreement") with Cantor Fitzgerald & Co. ("Cantor") under which the Company may offer and sell, from time to time at its sole discretion, shares of its common stock, having an aggregate offering price of up to $ 50.0 million through Cantor as its sales agent. During the three months ended March 31, 2024, the Company sold 339,912 shares of its common stock for net proceeds of $ 0.5 million under the Sales Agreement. 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 current plans and forecasted expenses, the Company expects that its cash and cash equivalents as of the filing date, May 10, 2024 will enable the Company to fund its planned operating expenses and capital expenditure requirements into the third quarter of 2025. 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 | 3 Months Ended |
Mar. 31, 2024 | |
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 described in Note 5. All intercompany balances and transactions have been eliminated. The Company’s consolidated financial statements have been prepared in conformity with accounting principles generally accepted in the United States of America (“U.S. GAAP”). In the opinion of management, the Company has made all necessary adjustments, which include normal recurring adjustments necessary for a fair statement of the Company’s consolidated financial position and results of operations for the interim periods presented. The results for the three months ended March 31, 2024 are not indicative of results to be expected for the year ending December 31, 2024, any other interim periods or any future year or period. These unaudited financial statements should be read in conjunction with the audited financial statements and related footnotes, which are included in the Company’s Annual Report on Form 10-K for the year ended December 31, 2023. 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 the estimate of the total amount of future royalty revenue and milestone payments to be generated over the life of the Purchase and Sale Agreement, 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. 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. Upfront and other payments may require deferral of revenue recognition to a future period until the Company performs its obligations under the arrangement. Amounts are recorded as accounts receivable when the Company’s right to consideration is unconditional. The Company does not assess whether a contract has a significant financing component if the expectation at contract inception is such that the period between payment by the customer and the transfer of the promised goods or services to the customer will be one year or less. Research and Development Costs Research and development costs are charged to expense as incurred and include: • employee-related expenses, including salaries, benefits, travel and share-based compensation expense for research and development personnel; • expenses incurred under agreements with contract research organizations, contract manufacturing organizations and consultants that conduct preclinical studies and clinical trials; • costs associated with preclinical and clinical development activities; • costs associated with submitting regulatory approval applications for the Company’s product candidates; • costs associated with training physicians on the suprachoroidal injection procedure and educating and providing them with appropriate product candidate information; • costs associated with technology and intellectual property licenses; • costs for the Company’s research and development facility; and • depreciation expense for assets used in research and development activities. Costs for certain development activities, such as clinical 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 Company estimates the fair value of stock options using a Black-Scholes option pricing model. 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 recipient's underlying role within the Company. Cash Equivalents Cash equivalents consist of short-term, highly liquid investments with an original term of three months or less at the date of purchase. Concentration of Credit Risk Arising From Cash Deposits in Excess of Insured Limits The Company maintains its cash in bank deposits that at times may exceed federally insured limits. The Company has not experienced any loss in such accounts. The Company believes it is not exposed to any significant risks with respect to its cash balances. Liability Related to the Sales of Future Royalties and Non-Cash Interest Expense In connection with the Purchase and Sale Agreement, 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 are 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 are amortized under the effective interest method over the estimated period the liability will be repaid. The Company estimates 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. Warrant Liabilities The Company accounts for warrants as either equity-classified or liability-classified instruments based on an assessment of the warrant’s specific terms and applicable authoritative guidance in FASB ASC Topic 480, Distinguishing Liabilities from Equity (ASC 480) and FASB ASC Topic 815, Derivatives and Hedging (ASC 815). The assessment considers whether the warrants (i) are freestanding financial instruments pursuant to ASC 480, (ii) meet the definition of a liability pursuant to ASC 480, and (iii) meet all of the requirements for equity classification under ASC 815, including whether the warrants are indexed to the Company's own stock and whether the warrant holders could potentially require “net cash settlement” in a circumstance outside of the Company’s control, among other conditions for equity classification. This assessment, which requires the use of professional judgment, is conducted at the time of warrant issuance and as of each subsequent quarterly period end date while the warrants are outstanding. For warrants that meet all criteria for equity classification, the warrants are required to be recorded as a component of additional paid-in capital, on the consolidated statement of stockholders’ deficit at the time of issuance. For warrants that do not meet all the criteria for equity classification, the warrants are required to be recorded at their initial fair value on the date of issuance and on each balance sheet date thereafter. The Company’s warrant liabilities are measured at fair value using a simulation model which takes into account, as of the valuation date, factors including the current exercise price, the expected life of the warrant, the current price of the Company's common stock, the expected volatility, holding cost, the risk-free interest rate for the term of the warrant and the likelihood of achieving certain future milestone events and the related impact to the price of the Company's common stock. The warrant liability is revalued at each reporting period and changes in fair value are recognized in other expense in the consolidated statements of operations. The selection of the appropriate valuation model and the inputs and assumptions that are required to determine the valuation requires significant judgment and requires management to make estimates and assumptions that affect the reported amount of the related liability and reported amounts of the change in fair value. Actual results could differ from those estimates, and changes in these estimates are recorded when known. |
Property and Equipment, Net
Property and Equipment, Net | 3 Months Ended |
Mar. 31, 2024 | |
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 March 31, December 31, Furniture and fixtures 5 $ 249 $ 249 Machinery and equipment 5 659 581 Computer equipment 3 20 20 Leasehold improvements Lesser of or 476 476 Work in process 2,738 2,590 Total property and equipment 4,142 3,916 Less: Accumulated depreciation ( 948 ) ( 920 ) Property and equipment, net $ 3,194 $ 2,996 |
Accrued Liabilities
Accrued Liabilities | 3 Months Ended |
Mar. 31, 2024 | |
Payables and Accruals [Abstract] | |
Accrued Liabilities | 4. Accrued Liabilities Accrued liabilities consisted of the following (in thousands): March 31, December 31, 2024 2023 Accrued research and development $ 2,220 $ 2,078 Accrued employee costs 592 1,862 Accrued professional fees 288 38 Accrued expense 970 191 $ 4,070 $ 4,169 |
Royalty Purchase and Sale Agree
Royalty Purchase and Sale Agreement | 3 Months Ended |
Mar. 31, 2024 | |
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 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 f or, 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 which was released to HCR pursuant to the Letter Agreement described below. 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 Purchase and Sale 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. On December 22, 2023, the Company, through its wholly owned subsidiary Royalty Sub, entered into the Letter Agreement with the Agent amending the Purchase and Sale Agreement. Pursuant to the terms of the Letter Agreement, Royalty Sub and Agent mutually agreed that Royalty Sub waived any and all rights to the First Milestone Payment in connection with the closing of the transactions contemplated by the Purchase and Sale Agreement and agreed to the release of the First Milestone Payment to Agent. 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 for the three months ended March 31, 2024 (in thousands): Royalty Purchase and Sale Agreement balance at December 31, 2023 $ 41,988 Non-cash interest expense 2,403 Balance at March 31, 2024 $ 44,391 Effective interest rate 22.0 % |
Common Stock
Common Stock | 3 Months Ended |
Mar. 31, 2024 | |
Equity [Abstract] | |
Common Stock | 6. Common Stock The Company’s amended and restated certificate of incorporation authorizes the Company to issue 200,000,000 shares of $ 0.001 par value common stock. As of March 31, 2024 and December 31, 2023, there were 74,731,139 and 62,850,841 shares of common stock outstanding, respectively. |
Common Stock Warrants
Common Stock Warrants | 3 Months Ended |
Mar. 31, 2024 | |
Stock Purchase Warrants [Abstract] | |
Common Stock Warrants | 7. Common Stock Warrants In September 2016, in connection with a loan agreement, the Company issued warrants to purchase up to 29,796 shares of common stock at a price per share of $ 10.74 . The warrants expire in September 2026 , or earlier upon the occurrence of specified mergers or acquisitions of the Company, and are immediately exercisable . The warrants were recorded in equity at the time of issuance and as of March 31, 2024 had a weighted average remaining life of 2.5 years. On February 6, 2024, the Company entered into a securities purchase agreement with institutional investors and an existing stockholder, pursuant to which the Company issued and sold, in a registered direct offering (i) an aggregate of 11,111,111 Shares of its common stock; and (ii) Warrants to purchase up to 11,111,111 shares of common stock. The combined purchase price of each Share and accompanying Warrant was $ 1.35 . The exercise price for the Warrants is $ 1.62 per share. The Warrants will be exercisable beginning August 9, 2024 and will expire on August 9, 2029 . The Company recorded the initial fair value of the Warrants of $ 10.3 million as warrant liabilities and $ 4.7 million attributable to common stock as additional paid in capital in the consolidated balance sheets. The issuance costs were allocated among the warrants and common stock consistent with the allocation between amounts recorded as warrant liabilities and common stock. The issuance costs allocated to the Warrants as well as the change in the fair value of the Warrants during the period are recorded in other expense in the consolidated statements of operations. The issuance costs allocated to common stock were recorded as a reduction to additional paid in capital. The following table summarizes the change in fair value of the warrant liabilities during the three months ended March 31, 2024 (in thousands): Fair value of warrants at issuance February 9, 2024 $ 10,327 Change in fair value during the period 712 Fair value of warrants at March 31, 2024 $ 11,039 The following table summarizes certain key inputs for the valuation of the Warrants at March 31, 2024: Common stock price $ 1.53 Exercise price per share $ 1.62 Expected volatility 61.00 % Risk-free interest rate 4.12 % Contractual term (in years) 5.36 Expected dividend yield — % |
Share-Based Compensation
Share-Based Compensation | 3 Months Ended |
Mar. 31, 2024 | |
Share-Based Payment Arrangement [Abstract] | |
Share-Based Compensation | 8. Share-Based Compensation Share-based compensation is accounted for in accordance with the provisions of ASC 718, Compensation-Stock Compensation . Stock Options The Company has granted stock option awards to employees, directors and consultants from its 2011 Stock Incentive Plan (the “2011 Plan”) and its 2016 Equity Incentive Plan (the “2016 Plan”). The estimated fair value of options granted is determined as of the date of grant using the Black-Scholes option pricing model. The resulting fair value is recognized ratably over the requisite service period, which is generally the vesting period of the awards. Share-based compensation expense for options granted under the 2016 Plan is reflected in the statements of operations as follows (in thousands): Three Months Ended 2024 2023 Research and development $ 420 $ 311 General and administrative 382 396 Total $ 802 $ 707 The following table summarizes the activity related to stock options granted under the 2011 Plan and the 2016 Plan during the three months ended March 31, 2024: Weighted Number of Average Shares Exercise Price Options outstanding at December 31, 2023 9,865,770 $ 2.83 Granted 2,606,875 1.34 Exercised ( 10,000 ) 1.24 Forfeited ( 122,815 ) 2.83 Options outstanding at March 31, 2024 12,339,830 2.52 Options exercisable at December 31, 2023 5,494,746 3.83 Options exercisable at March 31, 2024 6,174,281 3.58 As of March 31, 2024, the Company had $ 6.2 million of unrecognized compensation expense related to unvested stock options, which is expected to be recognized over a weighted average period of 2.8 years. 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): Three Months Ended 2024 2023 Research and development $ 119 $ 169 General and administrative 138 161 Total $ 257 $ 330 The following table summarizes the activity related to RSUs during the three months ended March 31, 2024: Weighted Average Number of Grant Date Shares Fair Value Non-vested RSUs outstanding at December 31, 2023 834,899 $ 3.01 Vested ( 397,594 ) 3.07 Non-vested RSUs outstanding at March 31, 2024 437,305 2.96 As of March 31, 2024, the Company had $ 1.1 million of unrecognized compensation expense related to the RSUs which is expected to be recognized over a weighted average period of 1.3 years. Employee Stock Purchase Plan The 2016 Employee Stock Purchase Plan (the “2016 ESPP”) became effective on June 1, 2016. The 2016 ESPP is considered a compensatory plan and the fair value of the discount and the look-back period are estimated using the Black-Scholes option pricing model and expense is recognized over the six-month withholding period prior to the purchase date. The share-based compensation expense recognized for the 2016 ESPP is reflected in the statements of operations as follows (in thousands): Three Months Ended 2024 2023 Research and development $ 3 $ 3 General and administrative — 1 Total $ 3 $ 4 During the three months ended March 31, 2024, the Company issued 21,681 shares of common stock purchased under the 2016 ESPP. |
Commitment and Contingencies
Commitment and Contingencies | 3 Months Ended |
Mar. 31, 2024 | |
Commitments and Contingencies Disclosure [Abstract] | |
Commitments and Contingencies | 9. Commitments and Contingencies Lease Commitment Summary In November 2022, the Company signed an amended office lease agreement to lease approximately 14,000 square feet of office space in Alpharetta, Georgia for its corporate headquarters. The amended office lease agreement is for a four year term with a renewal option for an additional 38 months. Rental payments are $ 30,747 per month subject to an increase of 3 % per year. Rent expense under this lease is recognized on a straight-line basis over the term of the lease. In addition, the office lease agreement requires payment of the pro-rata share of the annual operating expenses associated with the premises. The Company recognizes a right-of-use asset for the right to use the underlying asset for the lease term, and a lease liability, which represents the present value of the Company’s obligation to make payments over the lease term. The renewal option is not included in the calculation of the right-of-use asset and the lease liabilities as the Company has not yet determined if the Alpharetta, Georgia lease will be renewed. 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. Georgia Tech License Agreement As described in Note 1, the Company entered into a fourth amendment to the Georgia Tech License Agreement pursuant to which the parties agreed to revised Maintenance Fee payments. The Company paid the Maintenance Fee for 2023 in February 2024. The remaining annual Maintenance Fee payments are due on October 1st of each year from 2024 through 2028, as show in the table below (in thousands). Year Ending December 31, Amount 2024 $ 250 2025 250 2026 350 2027 400 2028 500 Total $ 1,750 Contract Service Providers In the course of the Company’s normal business operations, it has agreements with contract service providers to assist in the performance of its research and development, clinical research and manufacturing. Substantially all of these contracts are on an as needed basis. |
License and Other Agreements
License and Other Agreements | 3 Months Ended |
Mar. 31, 2024 | |
License And Other Agreement [Abstract] | |
License and Other Agreements | 10. License and Other Agreements Bausch + Lomb On October 22, 2019, the Company entered into a License Agreement (as amended, the "Bausch License Agreement") with Bausch + Lomb (“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 (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 aggregate of $ 20.0 million in upfront and milestone payments. In addition, Bausch has agreed to pay up to an aggregate of $ 55.0 million in additional milestone payments upon the achievement of (i) specified regulatory approvals for specifi ed additional indications of XIPERE and (ii) specified levels of annual net sales (as defined in the Bausch License Agreement). Further, during the applicable royalty term, the Company will also be entitled to receive tiered royalties at increasing percentages, from the high-teens to twenty percent, based on XIPERE achieving certain annual net sales thresholds in the Territory, in each case subject to reductions in specified circumstances; provided that the Company will not receive any royalties on the first $ 45.0 million of cumulative net sales of all products in the Territory. Bausch 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. Arctic Vision (Hong Kong) Limited On March 10, 2020, the Company entered into a License Agreement (the “Arctic License Agreement”) with Arctic Vision (Hong Kong) Limited (“Arctic Vision”). Pursuant to the Arctic License Agreement, the Company has granted an exclusive license to Arctic Vision to develop, distribute, promote, market and commercialize XIPERE, subject to specified exceptions, in China, Hong Kong, Macau, Taiwan and South Korea (the “Arctic Territory”). Under the terms of the Arctic License Agreement, neither party may commercialize XIPERE in the other party’s territory. Arctic Vision has agreed to use commercially reasonable efforts to pursue the development and commercialization of XIPERE for indications associated with uveitis in the Arctic Territory. In addition, upon receipt of the Company’s consent, Arctic Vision will have the right, but not the obligation, to develop and commercialize XIPERE for additional indications in the Arctic Territory. Pursuant to the Arctic License Agreement, Arctic Vision has paid the Company an aggregate of $ 9.0 million in upf ront and milestone payments. In addition, Arctic Vision has agreed to pay the Company up to $ 22.5 million in development and sales milestones. Further, during the applicable royalty term, the Company will also be entitled to receive tiered royalties of ten to twelve percent of net sales based on achieving certain annual net sales thresholds in the Arctic Territory, subject to customary reductions, payable on a product-by-product and country-by-country basis, commencing at launch in such country and lasting until the latest of (i) the date that all valid claims within the licensed patent rights covering XIPERE have expired, (ii) the date of the loss of marketing or regulatory exclusivity of XIPERE in a given country, or (iii) ten years from the first commercial sale of XIPERE in a given country. 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. In August 2021, the Company entered into an amendment to the Arctic 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. BioCryst Pharmaceuticals, Inc. On November 1, 2023, the Company entered into the BioCryst License Agreement pursuant to which the Company granted BioCryst an exclusive, worldwide and sublicensable license to the Company’s SCS Microinjector for the delivery of BioCryst’s proprietary plasma kallikrein inhibitor known as avoralstat for the treatment and prevention of DME. The Company received an upfront license fee payment of $ 5.0 million in connection with signing of the BioCryst License Agreement. In addition, the Company is eligible to receive up to an additional $ 30.0 million in clinical and regulatory milestone payments, and up to a total of $ 47.5 million in a series of post-approval sales-based milestone payments based on the achievement of annual global net product sales milestones up to $ 2.0 billion. Further, during the royalty term, BioCryst has also agreed to pay the Company tiered mid-single digit royalties on annual global net product sales, with the highest royalty rate applied to sales over $ 1.5 billion, subject to reductions in specified circumstances. 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. BioCryst will be responsible for all development, regulatory and commercialization activities for avoralstat. The Company is responsible for supplying SCS Microinjectors to meet BioCryst’s reasonable needs. Other The Company periodically enters into short-term agreements with other customers to evaluate the potential use of its proprietary SCS Microinjector with third-party product candidates for the treatment of various diseases. Funds received from these agreements are recognized as revenue over the term of the agreement. |
Fair Value Measurements
Fair Value Measurements | 3 Months Ended |
Mar. 31, 2024 | |
Fair Value Disclosures [Abstract] | |
Fair Value Measurements | 11. Fair Value Measurements The Company’s material financial instruments at March 31, 2024 and December 31, 2023 consisted primarily of cash and cash equivalents. The fair values of cash and cash equivalents, other current assets and accounts payable approximate their respective carrying values due to the short term nature of these instruments and are classified as Level 1 in the fair value hierarchy. The fair value of the liability related to the sales of future royalties (see Note 5) approximates the carrying value and is classified as Level 1 in the fair value hierarchy. The fair value of the warrant liabilities (see Note 7) require significant unobservable inputs and is classified as Level 3 in the fair value hierarchy. There were no transfers between Levels 1, 2 and 3 during the three months ended March 31, 2024 and the year ended December 31, 2023. |
Related Party Transactions
Related Party Transactions | 3 Months Ended |
Mar. 31, 2024 | |
Related Party Transactions [Abstract] | |
Related Party Transactions Disclosure [Text Block] | 12. Related Party Transactions A member of the Company's Board of Directors is chief executive officer of a company that is a vendor of the Company. As of March 31, 2024, the Company has recorded $ 17,000 in accounts payable and $ 0.2 million in accrued expense with this vendor in the consolidated balance sheets. For the three months ended March 31, 2024, the Company has recorded $ 0.3 million of expense in the consolidated statements of operations. The chair of the board of directors of BioCryst also serves on the Company’s Board of Directors. For the three months ended March 31, 2024, the Company has recorded $ 75,000 in license and other revenue in the consolidated statements of operations. |
Net Loss per Share
Net Loss per Share | 3 Months Ended |
Mar. 31, 2024 | |
Earnings Per Share [Abstract] | |
Net Loss Per Share | 13. Net Loss Per Share Basic net loss per share is calculated by dividing the net loss by the weighted average number of shares of common stock outstanding for the period, without consideration of the dilutive effect of potential common stock equivalents. Diluted net loss per share gives effect to all dilutive potential shares of common stock outstanding during this period. For all periods presented, the Company’s potential common stock equivalents, which included stock options, restricted stock units and common stock warrants, have been excluded from the computation of diluted net loss per share as their inclusion would have the effect of reducing the net loss per share. Therefore, the denominator used to calculate both basic and diluted net loss per share is the same in all periods presented. The Company’s potential common stock equivalents that have been excluded from the computation of diluted net loss per share for all periods presented because of their antidilutive effect consisted of the following: Three Months Ended 2024 2023 Outstanding stock options 12,339,830 8,931,659 Non-vested restricted stock units 437,305 899,041 Common stock warrants 11,140,907 29,796 23,918,042 9,860,496 |
Significant Accounting Polici_2
Significant Accounting Policies (Policies) | 3 Months Ended |
Mar. 31, 2024 | |
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 described in Note 5. All intercompany balances and transactions have been eliminated. The Company’s consolidated financial statements have been prepared in conformity with accounting principles generally accepted in the United States of America (“U.S. GAAP”). In the opinion of management, the Company has made all necessary adjustments, which include normal recurring adjustments necessary for a fair statement of the Company’s consolidated financial position and results of operations for the interim periods presented. The results for the three months ended March 31, 2024 are not indicative of results to be expected for the year ending December 31, 2024, any other interim periods or any future year or period. These unaudited financial statements should be read in conjunction with the audited financial statements and related footnotes, which are included in the Company’s Annual Report on Form 10-K for the year ended December 31, 2023. |
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 the estimate of the total amount of future royalty revenue and milestone payments to be generated over the life of the Purchase and Sale Agreement, 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. |
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. Upfront and other payments may require deferral of revenue recognition to a future period until the Company performs its obligations under the arrangement. Amounts are recorded as accounts receivable when the Company’s right to consideration is unconditional. The Company does not assess whether a contract has a significant financing component if the expectation at contract inception is such that the period between payment by the customer and the transfer of the promised goods or services to the customer will be one year or less. |
Research and Development Costs | Research and Development Costs Research and development costs are charged to expense as incurred and include: • employee-related expenses, including salaries, benefits, travel and share-based compensation expense for research and development personnel; • expenses incurred under agreements with contract research organizations, contract manufacturing organizations and consultants that conduct preclinical studies and clinical trials; • costs associated with preclinical and clinical development activities; • costs associated with submitting regulatory approval applications for the Company’s product candidates; • costs associated with training physicians on the suprachoroidal injection procedure and educating and providing them with appropriate product candidate information; • costs associated with technology and intellectual property licenses; • costs for the Company’s research and development facility; and • depreciation expense for assets used in research and development activities. Costs for certain development activities, such as clinical 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 Company estimates the fair value of stock options using a Black-Scholes option pricing model. 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 recipient's underlying role within the Company. |
Cash Equivalents | Cash Equivalents Cash equivalents consist of short-term, highly liquid investments with an original term of three months or less at the date of purchase. |
Concentration of Credit Risk Arising From Cash Deposits in Excess of Insured Limits | Concentration of Credit Risk Arising From Cash Deposits in Excess of Insured Limits The Company maintains its cash in bank deposits that at times may exceed federally insured limits. The Company has not experienced any loss in such accounts. The Company believes it is not exposed to any significant risks with respect to its cash balances. |
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 In connection with the Purchase and Sale Agreement, 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 are 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 are amortized under the effective interest method over the estimated period the liability will be repaid. The Company estimates 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. |
Warrant Liabilities | Warrant Liabilities The Company accounts for warrants as either equity-classified or liability-classified instruments based on an assessment of the warrant’s specific terms and applicable authoritative guidance in FASB ASC Topic 480, Distinguishing Liabilities from Equity (ASC 480) and FASB ASC Topic 815, Derivatives and Hedging (ASC 815). The assessment considers whether the warrants (i) are freestanding financial instruments pursuant to ASC 480, (ii) meet the definition of a liability pursuant to ASC 480, and (iii) meet all of the requirements for equity classification under ASC 815, including whether the warrants are indexed to the Company's own stock and whether the warrant holders could potentially require “net cash settlement” in a circumstance outside of the Company’s control, among other conditions for equity classification. This assessment, which requires the use of professional judgment, is conducted at the time of warrant issuance and as of each subsequent quarterly period end date while the warrants are outstanding. For warrants that meet all criteria for equity classification, the warrants are required to be recorded as a component of additional paid-in capital, on the consolidated statement of stockholders’ deficit at the time of issuance. For warrants that do not meet all the criteria for equity classification, the warrants are required to be recorded at their initial fair value on the date of issuance and on each balance sheet date thereafter. The Company’s warrant liabilities are measured at fair value using a simulation model which takes into account, as of the valuation date, factors including the current exercise price, the expected life of the warrant, the current price of the Company's common stock, the expected volatility, holding cost, the risk-free interest rate for the term of the warrant and the likelihood of achieving certain future milestone events and the related impact to the price of the Company's common stock. The warrant liability is revalued at each reporting period and changes in fair value are recognized in other expense in the consolidated statements of operations. The selection of the appropriate valuation model and the inputs and assumptions that are required to determine the valuation requires significant judgment and requires management to make estimates and assumptions that affect the reported amount of the related liability and reported amounts of the change in fair value. Actual results could differ from those estimates, and changes in these estimates are recorded when known. |
Property and Equipment, Net (Ta
Property and Equipment, Net (Tables) | 3 Months Ended |
Mar. 31, 2024 | |
Property, Plant and Equipment [Abstract] | |
Schedule of Property and Equipment, Net | Property and equipment, net consisted of the following (dollar amounts in thousands): Estimated March 31, December 31, Furniture and fixtures 5 $ 249 $ 249 Machinery and equipment 5 659 581 Computer equipment 3 20 20 Leasehold improvements Lesser of or 476 476 Work in process 2,738 2,590 Total property and equipment 4,142 3,916 Less: Accumulated depreciation ( 948 ) ( 920 ) Property and equipment, net $ 3,194 $ 2,996 |
Accrued Liabilities (Tables)
Accrued Liabilities (Tables) | 3 Months Ended |
Mar. 31, 2024 | |
Payables and Accruals [Abstract] | |
Schedule of Accrued Liabilities | Accrued liabilities consisted of the following (in thousands): March 31, December 31, 2024 2023 Accrued research and development $ 2,220 $ 2,078 Accrued employee costs 592 1,862 Accrued professional fees 288 38 Accrued expense 970 191 $ 4,070 $ 4,169 |
Royalty Purchase and Sale Agr_2
Royalty Purchase and Sale Agreement (Tables) | 3 Months Ended |
Mar. 31, 2024 | |
Royalty Purchase and Sales Agreement [Abstract] | |
Schedule of Activity of Royalty Obligation | The following table summarizes the activity of the Purchase and Sale Agreement for the three months ended March 31, 2024 (in thousands): Royalty Purchase and Sale Agreement balance at December 31, 2023 $ 41,988 Non-cash interest expense 2,403 Balance at March 31, 2024 $ 44,391 Effective interest rate 22.0 % |
Common Stock Warrants (Tables)
Common Stock Warrants (Tables) | 3 Months Ended |
Mar. 31, 2024 | |
Stock Purchase Warrants [Abstract] | |
Schedule of Change in Fair Value of Warrant Liabilities | The following table summarizes the change in fair value of the warrant liabilities during the three months ended March 31, 2024 (in thousands): Fair value of warrants at issuance February 9, 2024 $ 10,327 Change in fair value during the period 712 Fair value of warrants at March 31, 2024 $ 11,039 |
Schedule of Valuation of the Warrants | The following table summarizes certain key inputs for the valuation of the Warrants at March 31, 2024: Common stock price $ 1.53 Exercise price per share $ 1.62 Expected volatility 61.00 % Risk-free interest rate 4.12 % Contractual term (in years) 5.36 Expected dividend yield — % |
Share-Based Compensation (Table
Share-Based Compensation (Tables) | 3 Months Ended |
Mar. 31, 2024 | |
Summary of Share-based Compensation Expense | Share-based compensation expense for options granted under the 2016 Plan is reflected in the statements of operations as follows (in thousands): Three Months Ended 2024 2023 Research and development $ 420 $ 311 General and administrative 382 396 Total $ 802 $ 707 |
Summary of Activity Related to Stock Options | The following table summarizes the activity related to stock options granted under the 2011 Plan and the 2016 Plan during the three months ended March 31, 2024: Weighted Number of Average Shares Exercise Price Options outstanding at December 31, 2023 9,865,770 $ 2.83 Granted 2,606,875 1.34 Exercised ( 10,000 ) 1.24 Forfeited ( 122,815 ) 2.83 Options outstanding at March 31, 2024 12,339,830 2.52 Options exercisable at December 31, 2023 5,494,746 3.83 Options exercisable at March 31, 2024 6,174,281 3.58 |
Restricted Stock Units (RSUs) | |
Summary of Share-based Compensation Expense | The total share-based compensation expense related to RSUs is reflected in the statements of operations as follows (in thousands): Three Months Ended 2024 2023 Research and development $ 119 $ 169 General and administrative 138 161 Total $ 257 $ 330 |
Summary of the Activity Related to RSUs | The following table summarizes the activity related to RSUs during the three months ended March 31, 2024: Weighted Average Number of Grant Date Shares Fair Value Non-vested RSUs outstanding at December 31, 2023 834,899 $ 3.01 Vested ( 397,594 ) 3.07 Non-vested RSUs outstanding at March 31, 2024 437,305 2.96 |
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 as follows (in thousands): Three Months Ended 2024 2023 Research and development $ 3 $ 3 General and administrative — 1 Total $ 3 $ 4 |
Commitment and Contingencies (T
Commitment and Contingencies (Tables) | 3 Months Ended |
Mar. 31, 2024 | |
Commitments and Contingencies Disclosure [Abstract] | |
Schedule of Annual Maintenance Fee Payments | The remaining annual Maintenance Fee payments are due on October 1st of each year from 2024 through 2028, as show in the table below (in thousands). Year Ending December 31, Amount 2024 $ 250 2025 250 2026 350 2027 400 2028 500 Total $ 1,750 |
Net Loss per Share (Tables)
Net Loss per Share (Tables) | 3 Months Ended |
Mar. 31, 2024 | |
Earnings Per Share [Abstract] | |
Potential Common Stock Equivalents Excluded from Computation of Diluted Net Loss per Share | The Company’s potential common stock equivalents that have been excluded from the computation of diluted net loss per share for all periods presented because of their antidilutive effect consisted of the following: Three Months Ended 2024 2023 Outstanding stock options 12,339,830 8,931,659 Non-vested restricted stock units 437,305 899,041 Common stock warrants 11,140,907 29,796 23,918,042 9,860,496 |
The Company - Additional Inform
The Company - Additional Information (Details) - USD ($) | 3 Months Ended | 6 Months Ended | ||||||
Feb. 06, 2024 | Nov. 01, 2023 | Aug. 08, 2022 | Mar. 31, 2024 | Jun. 30, 2023 | Dec. 31, 2023 | May 31, 2023 | Sep. 30, 2016 | |
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items] | ||||||||
Entity incorporation date | May 26, 2011 | |||||||
Cash and cash equivalents | $ 35,355,000 | $ 28,920,000 | ||||||
Maintenance Fee Operating License Liability Payments Due Year Five | 500,000 | |||||||
Maintenance Fee Operating License Liability Payments Due Year Four | 400,000 | |||||||
Maintenance Fee Operating License Liability Payments Due Year Three | 350,000 | |||||||
Maintenance Fee Operating license Liability Payments Due Year Two | $ 250,000 | |||||||
Proceeds From Registered Direct Offering | $ 13,900,000 | |||||||
Common stock warrants | ||||||||
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items] | ||||||||
Warrant Expiration Date | Aug. 09, 2029 | |||||||
Class of Warrant or Right, Date from which Warrants or Rights Exercisable | Aug. 09, 2024 | |||||||
Class of warrant Exercise | $ 1.62 | |||||||
Common Stock Warrants [Member] | ||||||||
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items] | ||||||||
Class of warrant Exercise | $ 10.74 | |||||||
Purchase price of share and warrant | $ 1.35 | |||||||
Maximum [Member] | ||||||||
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items] | ||||||||
Number of stock that can be purchased by each warrant | 29,796 | |||||||
Maximum [Member] | Common Stock | ||||||||
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items] | ||||||||
Number of shares sold under facility | 11,111,111 | |||||||
Maximum [Member] | Common stock warrants | ||||||||
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items] | ||||||||
Number of stock that can be purchased by each warrant | 11,111,111 | |||||||
Cantor Fitzgerald & Co. | Common Stock | ||||||||
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items] | ||||||||
Number of shares sold under facility | 339,912 | |||||||
Net proceeds from issuance of stock | $ 500,000 | |||||||
Letter Agreement [Member] | ||||||||
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items] | ||||||||
Milestone Payments | $ 12,500,000 | |||||||
License Arrangement [Member] | ||||||||
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items] | ||||||||
Clinical And Regulatory Milestone Payments | $ 30,000,000 | |||||||
Sales-Based Milestone Payments | 47,500,000 | |||||||
Global Net Product Sales Milestones | 2,000,000,000 | |||||||
Minimum Sales To Applied Highest Royalty Rate | 1,500,000,000 | |||||||
Upfront License Fee | $ 5,000,000 | |||||||
At-the-market Sales Agreement | Cowen and Company LLC | ||||||||
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items] | ||||||||
Net proceeds from issuance of stock | $ 300,000 | |||||||
At-the-market Sales Agreement | Cowen and Company LLC | Common Stock | In May 2023 | ||||||||
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items] | ||||||||
Number of shares sold under facility | 214,128 | |||||||
At-the-market Sales Agreement | Cantor Fitzgerald & Co. | In May 2023 | ||||||||
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items] | ||||||||
Common stock shares aggregate offering price | $ 50,000,000 |
Property and Equipment, Net - S
Property and Equipment, Net - Schedule of Property and Equipment, Net (Details) - USD ($) $ in Thousands | 3 Months Ended | |
Mar. 31, 2024 | Dec. 31, 2023 | |
Property Plant And Equipment [Line Items] | ||
Total property and equipment | $ 4,142 | $ 3,916 |
Less: Accumulated depreciation | (948) | (920) |
Property and equipment, net | 3,194 | 2,996 |
Furniture and Fixtures | ||
Property Plant And Equipment [Line Items] | ||
Total property and equipment | $ 249 | 249 |
Estimated Useful Lives (Years) | 5 years | |
Machinery and Equipment | ||
Property Plant And Equipment [Line Items] | ||
Total property and equipment | $ 659 | 581 |
Estimated Useful Lives (Years) | 5 years | |
Computer Equipment | ||
Property Plant And Equipment [Line Items] | ||
Total property and equipment | $ 20 | 20 |
Estimated Useful Lives (Years) | 3 years | |
Leasehold Improvements | ||
Property Plant And Equipment [Line Items] | ||
Total property and equipment | $ 476 | 476 |
Property, Plant, and Equipment, Useful Life, Term | Lesser ofuseful life orremaininglease term | |
Work in process | ||
Property Plant And Equipment [Line Items] | ||
Total property and equipment | $ 2,738 | $ 2,590 |
Accrued Liabilities - Schedule
Accrued Liabilities - Schedule of Accrued Liabilities (Details) - USD ($) $ in Thousands | Mar. 31, 2024 | Dec. 31, 2023 |
Payables and Accruals [Abstract] | ||
Accrued research and development | $ 2,220 | $ 2,078 |
Accrued employee costs | 592 | 1,862 |
Accrued professional fees | 288 | 38 |
Accrued expense | 970 | 191 |
Accrued liabilities, current | $ 4,070 | $ 4,169 |
Royalty Purchase and Sale Agr_3
Royalty Purchase and Sale Agreement (Additional Information) (Details) - USD ($) $ in Millions | 3 Months Ended | |
Aug. 08, 2022 | Mar. 31, 2024 | |
Research and Development Arrangement, Contract to Perform for Others [Line Items] | ||
Initial proceeds from royalty purchase and sales agreement | $ 32.5 | |
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 Purchase and Sale 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.On December 22, 2023, the Company, through its wholly owned subsidiary Royalty Sub, entered into the Letter Agreement with the Agent amending the Purchase and Sale Agreement. Pursuant to the terms of the Letter Agreement, Royalty Sub and Agent mutually agreed that Royalty Sub waived any and all rights to the First Milestone Payment in connection with the closing of the transactions contemplated by the Purchase and Sale Agreement and agreed to the release of the First Milestone Payment to Agent. | |
Debt related commitment fees and debt related issuance costs | $ 1.9 | |
Royalty Purchase And Sale Agreement [Member] | ||
Research and Development Arrangement, Contract to Perform for Others [Line Items] | ||
Issuance costs | 1.5 | |
Proceeds from royalty purchase and sale agreement, net of issuance costs | $ 30.6 | |
Royalty Sub Member [Member] | Royalty Purchase And Sale Agreement [Member] | ||
Research and Development Arrangement, Contract to Perform for Others [Line Items] | ||
Initial proceeds from royalty purchase and sales agreement net of certain expenses | $ 32.1 | |
First milestone proceeds from royalty purchase and sale agreement | 12.5 | |
Second milestone proceeds from royalty purchase and sale agreement | 20 | |
Royalty Sub Member [Member] | Royalty Purchase And Sale Agreement [Member] | Maximum [Member] | ||
Research and Development Arrangement, Contract to Perform for Others [Line Items] | ||
Maximum proceeds from royalty purchase and sale agreement | $ 65 |
Royalty Purchase and Sale Agr_4
Royalty Purchase and Sale Agreement - Schedule of Activity of Royalty Obligation (Details) - USD ($) $ in Thousands | 3 Months Ended | |
Mar. 31, 2024 | Mar. 31, 2023 | |
Royalty Obligation [Abstract] | ||
Royalty purchase and sale agreement balance at December 31, 2023 | $ 41,988 | |
Non-cash interest expense | 2,403 | $ 2,167 |
Balance at March 31, 2024 | $ 44,391 | |
Effective interest rate | 22% |
Common Stock - Additional Infor
Common Stock - Additional Information (Details) - $ / shares | Mar. 31, 2024 | Dec. 31, 2023 |
Equity [Abstract] | ||
Common stock, shares authorized | 200,000,000 | 200,000,000 |
Common stock, par value | $ 0.001 | $ 0.001 |
Common stock, shares outstanding | 74,731,139 | 62,850,841 |
Common Stock Warrants - Additio
Common Stock Warrants - Additional Information (Details) - USD ($) $ / shares in Units, $ in Thousands | 1 Months Ended | 3 Months Ended | ||
Feb. 06, 2024 | Sep. 30, 2016 | Mar. 31, 2024 | Dec. 31, 2023 | |
Class Of Warrant Or Right [Line Items] | ||||
Weighted average remaining life of warrants | 2 years 6 months | |||
Fair value of warrants at issuance | $ 10,327 | |||
Warrant liabilities | $ 11,039 | $ 0 | ||
Maximum | ||||
Class Of Warrant Or Right [Line Items] | ||||
Number of stock that can be purchased by each warrant | 29,796 | |||
Convertible Stock Warrant | ||||
Class Of Warrant Or Right [Line Items] | ||||
Class of warrant Exercise | $ 10.74 | |||
Warrants expiration term | 2026-09 | |||
Purchase price of share and warrant | $ 1.35 | |||
Common Stock | Maximum | ||||
Class Of Warrant Or Right [Line Items] | ||||
Number of shares sold under facility | 11,111,111 | |||
Common stock warrants | ||||
Class Of Warrant Or Right [Line Items] | ||||
Class of warrant Exercise | $ 1.62 | |||
Warrant exercisable date | Aug. 09, 2024 | |||
Warrant expiration date | Aug. 09, 2029 | |||
Fair value of warrants at issuance | $ 10,300 | |||
Proceeds allocated to the common stock | $ 4,700 | |||
Common stock warrants | Maximum | ||||
Class Of Warrant Or Right [Line Items] | ||||
Number of stock that can be purchased by each warrant | 11,111,111 |
Common Stock Warrants - Schedul
Common Stock Warrants - Schedule of Change in Fair Value of the Warrant Liabilitie (Details) $ in Thousands | 3 Months Ended |
Mar. 31, 2024 USD ($) | |
Class of Warrant or Right [Line Items] | |
Fair value of warrants at issuance February 9, 2024 | $ 10,327 |
Change in fair value during the period | 712 |
Fair value of warrants at March 31, 2024 | $ 11,039 |
Common Stock Warrants - Sched_2
Common Stock Warrants - Schedule of Valuation of the Warrants (Details) - Warrant [Member] | Mar. 31, 2024 $ / shares shares |
Measurement Input, Common Stock Price [Member] | |
Class of Warrant or Right [Line Items] | |
Common stock price | $ / shares | $ 1.53 |
Measurement Input, Exercise Price Per Share [Member] | |
Class of Warrant or Right [Line Items] | |
Excercise price per share | shares | 1.62 |
Measurement Input, Expected Volatility [Member] | |
Class of Warrant or Right [Line Items] | |
Warrants outstanding, measurement input | 61 |
Measurement Input, Risk-free Interest Rate [Member] | |
Class of Warrant or Right [Line Items] | |
Warrants outstanding, measurement input | 4.12 |
Measurement Input, Contractual Term [Member] | |
Class of Warrant or Right [Line Items] | |
Contractual term (in years) | 5 years 4 months 9 days |
Measurement Input, Expected Dividend Yield [Member] | |
Class of Warrant or Right [Line Items] | |
Warrants outstanding, measurement input | 0 |
Share-Based Compensation - Addi
Share-Based Compensation - Additional Information (Details) $ in Millions | 3 Months Ended |
Mar. 31, 2024 USD ($) shares | |
2016 Employee Stock Purchase Plan | |
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | |
Issuance of common shares under employee stock purchase plan, shares | shares | 21,681 |
Employee Stock Option | |
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | |
Unrecognized compensation expense related to unvested stock options | $ 6.2 |
Expected to be recognized over a weighted average period | 2 years 9 months 18 days |
Restricted Stock Units (RSUs) | |
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | |
Expected to be recognized over a weighted average period | 1 year 3 months 18 days |
Unrecognized compensation expense related to the RSUs | $ 1.1 |
Share-Based Compensation - Summ
Share-Based Compensation - Summary of Share-based Compensation Expense (Details) - USD ($) $ in Thousands | 3 Months Ended | |
Mar. 31, 2024 | Mar. 31, 2023 | |
2016 Employee Stock Purchase Plan | ||
Employee Service Share Based Compensation Allocation Of Recognized Period Costs [Line Items] | ||
Share-based compensation expense | $ 3 | $ 4 |
2016 Employee Stock Purchase Plan | Research and Development | ||
Employee Service Share Based Compensation Allocation Of Recognized Period Costs [Line Items] | ||
Share-based compensation expense | 3 | 3 |
2016 Employee Stock Purchase Plan | General and Administrative | ||
Employee Service Share Based Compensation Allocation Of Recognized Period Costs [Line Items] | ||
Share-based compensation expense | 0 | 1 |
Employee Stock Option | 2011 Stock Incentive Plan, 2016 Equity Incentive Plan | ||
Employee Service Share Based Compensation Allocation Of Recognized Period Costs [Line Items] | ||
Share-based compensation expense | 802 | 707 |
Employee Stock Option | 2011 Stock Incentive Plan, 2016 Equity Incentive Plan | Research and Development | ||
Employee Service Share Based Compensation Allocation Of Recognized Period Costs [Line Items] | ||
Share-based compensation expense | 420 | 311 |
Employee Stock Option | 2011 Stock Incentive Plan, 2016 Equity Incentive Plan | General and Administrative | ||
Employee Service Share Based Compensation Allocation Of Recognized Period Costs [Line Items] | ||
Share-based compensation expense | 382 | 396 |
Restricted Stock Units (RSUs) | ||
Employee Service Share Based Compensation Allocation Of Recognized Period Costs [Line Items] | ||
Share-based compensation expense | 257 | 330 |
Restricted Stock Units (RSUs) | Research and Development | ||
Employee Service Share Based Compensation Allocation Of Recognized Period Costs [Line Items] | ||
Share-based compensation expense | 119 | 169 |
Restricted Stock Units (RSUs) | General and Administrative | ||
Employee Service Share Based Compensation Allocation Of Recognized Period Costs [Line Items] | ||
Share-based compensation expense | $ 138 | $ 161 |
Share-Based Compensation - Su_2
Share-Based Compensation - Summary of Activity Related to Stock Options (Details) - Employee Stock Option - 2011 Stock Incentive Plan, 2016 Equity Incentive Plan - $ / shares | 3 Months Ended | |
Mar. 31, 2024 | Dec. 31, 2023 | |
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | ||
Number of Shares, Options outstanding, Beginning balance | 9,865,770 | |
Number of Shares, Granted | 2,606,875 | |
Number of Shares, Exercised | (10,000) | |
Number of Shares, Forfeited | (122,815) | |
Number of Shares, Options outstanding, Ending balance | 12,339,830 | |
Number of Shares, Options exercisable | 6,174,281 | 5,494,746 |
Weighted Average Exercise Price, Options outstanding, Beginning balance | $ 2.83 | |
Weighted Average Exercise Price, Granted | 1.34 | |
Weighted Average Exercise Price, Exercised | 1.24 | |
Weighted Average Exercise Price, Forfeited | 2.83 | |
Weighted Average Exercise Price, Options outstanding, Ending balance | 2.52 | |
Weighted Average Exercise Price, Options exercisable | $ 3.58 | $ 3.83 |
Share-Based Compensation - Su_3
Share-Based Compensation - Summary of the Activity Related to RSUs (Details) - Restricted Stock Units (RSUs) | 3 Months Ended |
Mar. 31, 2024 $ / shares shares | |
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | |
Non-vested units outstanding, Number of Shares, Beginning balance | shares | 834,899 |
Number of Shares, Vested | shares | (397,594) |
Non-vested units outstanding, Number of Shares, Ending balance | shares | 437,305 |
Non-vested units outstanding, Weighted Average Exercise Price, Beginning balance | $ / shares | $ 3.01 |
Weighted Average Exercise Price, Vested | $ / shares | 3.07 |
Non-vested units outstanding, Weighted Average Exercise Price, Ending balance | $ / shares | $ 2.96 |
Commitment and Contingencies -
Commitment and Contingencies - Additional Information (Details) | 1 Months Ended | 3 Months Ended |
Nov. 30, 2022 USD ($) ft² | Mar. 31, 2024 | |
Commitment And Contingencies [Line Items] | ||
Lessee, operating lease, option to extend, description | The renewal option is not included in the calculation of the right-of-use asset and the lease liabilities as the Company has not yet determined if the Alpharetta, Georgia lease will be renewed. | |
GEORGIA | ||
Commitment And Contingencies [Line Items] | ||
Area of office leased | ft² | 14,000 | |
Operating lease agreement term | 4 years | |
Minimum monthly lease payments | $ | $ 30,747 | |
Percentage of increase per year | 3% |
Commitments and Contingencies -
Commitments and Contingencies - Annual Maintenance Fee payments are due on Oct 1st of each year (Details) $ in Thousands | Mar. 31, 2024 USD ($) |
Commitments and Contingencies Disclosure [Abstract] | |
2024 | $ 250 |
2025 | 250 |
2026 | 350 |
2027 | 400 |
2028 | 500 |
Total | $ 1,750 |
License and Other Agreements -
License and Other Agreements - Additional Information (Detail) - USD ($) $ in Thousands | 1 Months Ended | 3 Months Ended | |||||
Nov. 01, 2023 | Mar. 10, 2020 | Oct. 22, 2019 | Sep. 30, 2021 | Mar. 31, 2024 | Mar. 31, 2023 | Dec. 31, 2023 | |
Research And Development Arrangement Contract To Perform For Others [Line Items] | |||||||
Deferred revenue | $ 150 | $ 75 | |||||
License and other revenue | 230 | $ 4 | |||||
Bausch Health Ireland Limited | |||||||
Research And Development Arrangement Contract To Perform For Others [Line Items] | |||||||
Upfront and Milestone Payments | $ 20,000 | ||||||
Arctic Vision Limited | Maximum | |||||||
Research And Development Arrangement Contract To Perform For Others [Line Items] | |||||||
Threshold percentage of sales for tiered royalties | 12% | ||||||
Arctic Vision Limited | Minimum | |||||||
Research And Development Arrangement Contract To Perform For Others [Line Items] | |||||||
Threshold percentage of sales for tiered royalties | 10% | ||||||
XIPERE [Member] | Bausch Health Ireland Limited | |||||||
Research And Development Arrangement Contract To Perform For Others [Line Items] | |||||||
First cumulative net sales of products | $ 45,000 | ||||||
XIPERE [Member] | Bausch Health Ireland Limited | Maximum | |||||||
Research And Development Arrangement Contract To Perform For Others [Line Items] | |||||||
Additional milestone payments | $ 55,000 | ||||||
License Arrangement | |||||||
Research And Development Arrangement Contract To Perform For Others [Line Items] | |||||||
Clinical And Regulatory Milestone Payments | $ 30,000 | ||||||
Global Net Product Sales Milestones | 2,000,000 | ||||||
Minimum Sales To Applied Highest Royalty Rate | 1,500,000 | ||||||
License Arrangement | Arctic Vision Limited | |||||||
Research And Development Arrangement Contract To Perform For Others [Line Items] | |||||||
Consideration for Territory Expansion Received | $ 3,000 | ||||||
License Arrangement | Arctic Vision Limited | Upfront Payment | |||||||
Research And Development Arrangement Contract To Perform For Others [Line Items] | |||||||
Upfront and Milestone Payments | $ 9,000 | ||||||
License Arrangement | Arctic Vision Limited | Maximum | |||||||
Research And Development Arrangement Contract To Perform For Others [Line Items] | |||||||
Development milestone payments | $ 22,500 | ||||||
License Arrangement | BioCryst Pharmaceuticals, Inc | |||||||
Research And Development Arrangement Contract To Perform For Others [Line Items] | |||||||
Minimum Sales To Applied Highest Royalty Rate | 1,500,000 | ||||||
License Arrangement | BioCryst Pharmaceuticals, Inc | Upfront Payment | |||||||
Research And Development Arrangement Contract To Perform For Others [Line Items] | |||||||
License Fee Payment | 5,000 | ||||||
License Arrangement | BioCryst Pharmaceuticals, Inc | Maximum | |||||||
Research And Development Arrangement Contract To Perform For Others [Line Items] | |||||||
Milestone Payments | 30,000 | ||||||
Clinical And Regulatory Milestone Payments | 47,500 | ||||||
Global Net Product Sales Milestones | $ 2,000,000 |
Fair Value Measurements - Addit
Fair Value Measurements - Additional Information (Details) - USD ($) | Mar. 31, 2024 | Dec. 31, 2023 |
Fair Value Disclosures [Abstract] | ||
Significant transfers between Levels 1, 2 and 3 | $ 0 | $ 0 |
Related Party Transactions (Add
Related Party Transactions (Additional Information) (Details) - USD ($) | 3 Months Ended | |
Mar. 31, 2024 | Mar. 31, 2023 | |
Related Party Transaction [Line Items] | ||
Expenses | $ 8,439,000 | $ 7,609,000 |
License and other revenue | 75,000 | |
Related Party [Member] | ||
Related Party Transaction [Line Items] | ||
Expenses | 300,000 | |
License and other revenue | 75,000 | |
Accrued Liabilities [Member] | Related Party [Member] | ||
Related Party Transaction [Line Items] | ||
Liabilities | 200,000 | |
Accounts Payable [Member] | Related Party [Member] | ||
Related Party Transaction [Line Items] | ||
Liabilities | $ 17,000 |
Net Loss Per Share - Potential
Net Loss Per Share - Potential Common Stock Equivalents Excluded from Computation of Diluted Net Loss per Share (Details) - shares | 3 Months Ended | |
Mar. 31, 2024 | Mar. 31, 2023 | |
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] | ||
Antidilutive securities excluded from computation of earnings per share | 23,918,042 | 9,860,496 |
Outstanding Stock Options | ||
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] | ||
Antidilutive securities excluded from computation of earnings per share | 12,339,830 | 8,931,659 |
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 | 437,305 | 899,041 |
Common stock warrants | ||
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] | ||
Antidilutive securities excluded from computation of earnings per share | 11,140,907 | 29,796 |
Subsequent Event (Additional In
Subsequent Event (Additional Information) (Details) - License Arrangement [Member] $ in Millions | Nov. 01, 2023 USD ($) |
Subsequent Event [Line Items] | |
Upfront License Fee | $ 5 |
Clinical And Regulatory Milestone Payments | 30 |
Global Net Product Sales Milestones | 2,000 |
Minimum Sales To Applied Highest Royalty Rate | $ 1,500 |