Document And Entity Information
Document And Entity Information - shares | 3 Months Ended | |
Mar. 31, 2023 | May 02, 2023 | |
Cover [Abstract] | ||
Document Type | 10-Q | |
Amendment Flag | false | |
Document Period End Date | Mar. 31, 2023 | |
Document Fiscal Year Focus | 2023 | |
Document Fiscal Period Focus | Q1 | |
Trading Symbol | ALDX | |
Entity Registrant Name | ALDEYRA THERAPEUTICS, INC. | |
Entity Central Index Key | 0001341235 | |
Current Fiscal Year End Date | --12-31 | |
Entity Filer Category | Non-accelerated Filer | |
Entity Emerging Growth Company | false | |
Entity Small Business | true | |
Entity Common Stock, Shares Outstanding | 58,576,350 | |
Entity Current Reporting Status | Yes | |
Entity Shell Company | false | |
Title of 12(b) Security | Common Stock, $0.001 par value per share | |
Security Exchange Name | NASDAQ | |
Entity Interactive Data Current | Yes | |
Entity File Number | 001-36332 | |
Entity Tax Identification Number | 20-1968197 | |
Entity Address, Address Line One | 131 Hartwell Avenue | |
Entity Address, Address Line Two | Suite 320 | |
Entity Address, City or Town | Lexington | |
Entity Address, State or Province | MA | |
Entity Address, Postal Zip Code | 02421 | |
City Area Code | 781 | |
Local Phone Number | 761-4904 | |
Document Quarterly Report | true | |
Document Transition Report | false | |
Entity Incorporation, State or Country Code | DE |
Consolidated Balance Sheets (Un
Consolidated Balance Sheets (Unaudited) - USD ($) | Mar. 31, 2023 | Dec. 31, 2022 |
Current assets: | ||
Cash and cash equivalents | $ 165,028,105 | $ 144,419,364 |
Marketable securities | 0 | 29,881,520 |
Prepaid expenses and other current assets | 2,989,115 | 6,722,229 |
Total current assets | 168,017,220 | 181,023,113 |
Right-of-use assets | 189,033 | 249,265 |
Fixed assets, net | 12,539 | 19,279 |
Total assets | 168,218,792 | 181,291,657 |
Current liabilities: | ||
Accounts payable | 429,685 | 133,625 |
Accrued expenses | 14,433,679 | 14,065,885 |
Current portion of long-term debt | 954,325 | 911,763 |
Operating lease liabilities | 190,202 | 249,265 |
Total current liabilities | 16,007,891 | 15,360,538 |
Long-term debt, net of current portion | 14,967,688 | 14,923,090 |
Total liabilities | 30,975,579 | 30,283,628 |
Commitments and contingencies (Notes 13, 14, and 15) | ||
Stockholders' equity: | ||
Preferred stock, $0.001 par value, 15,000,000 shares authorized none issued and outstanding | 0 | 0 |
Common stock, $0.001 par value; 150,000,000 authorized and 58,791,603 and 58,560,078 shares issued and outstanding, respectively | 58,792 | 58,560 |
Additional paid-in capital | 509,516,738 | 507,770,045 |
Accumulated other comprehensive loss | 0 | (103,938) |
Accumulated deficit | (372,332,317) | (356,716,638) |
Total stockholders, equity | 137,243,213 | 151,008,029 |
Total liabilities and stockholders’ equity | $ 168,218,792 | $ 181,291,657 |
Consolidated Balance Sheets (_2
Consolidated Balance Sheets (Unaudited) (Parenthetical) - $ / shares | Mar. 31, 2023 | Dec. 31, 2022 |
Statement of Financial Position [Abstract] | ||
Preferred stock, par value | $ 0.001 | $ 0.001 |
Preferred stock, shares authorized | 15,000,000 | 15,000,000 |
Preferred stock, shares issued | 0 | 0 |
Preferred Stock, shares outstanding | 0 | 0 |
Common stock, par value | $ 0.001 | $ 0.001 |
Common stock, shares authorized | 150,000,000 | 150,000,000 |
Common stock, shares issued | 58,791,603 | 58,560,078 |
Common stock, shares outstanding | 58,791,603 | 58,560,078 |
Consolidated Statements of Oper
Consolidated Statements of Operations (Unaudited) - USD ($) | 3 Months Ended | |
Mar. 31, 2023 | Mar. 31, 2022 | |
Operating expenses: | ||
Research and development | $ 11,235,861 | $ 12,234,320 |
General and administrative | 5,567,416 | 4,249,387 |
Loss from operations | (16,803,277) | (16,483,707) |
Other income (expense): | ||
Interest income | 1,678,885 | 101,382 |
Interest expense | (491,287) | (405,967) |
Total other income (expense), net | 1,187,598 | (304,585) |
Net loss | $ (15,615,679) | $ (16,788,292) |
Earnings Per Share, Basic | $ (0.27) | $ (0.29) |
Earnings Per Share, Diluted | $ 0.27 | $ (0.29) |
Weighted Average Number of Shares Outstanding, Basic | 58,791,603 | 58,297,861 |
Weighted Average Number of Shares Outstanding, Diluted | 58,791,603 | 58,297,861 |
Consolidated Statements of Comp
Consolidated Statements of Comprehensive Loss (Unaudited) - USD ($) | 3 Months Ended | |
Mar. 31, 2023 | Mar. 31, 2022 | |
Statement of Comprehensive Income [Abstract] | ||
Net loss | $ (15,615,679) | $ (16,788,292) |
Other comprehensive income (loss): | ||
Unrealized gain (loss) on marketable securities, net of tax | 103,938 | (61,677) |
Total other comprehensive income (loss) | 103,938 | (61,677) |
Comprehensive loss | $ (15,511,741) | $ (16,849,969) |
Consolidated Statements of Stoc
Consolidated Statements of Stockholders' Equity (Unaudited) - USD ($) | Total | Common Stock [Member] | Common Stock [Member] Helio Vision Inc [Member] Founders [Member] | Additional Paid-in Capital [Member] | Additional Paid-in Capital [Member] Helio Vision Inc [Member] Founders [Member] | Accumulated Other Comprehensive Income (Loss), Net of Tax [Member] | Accumulated Deficit [Member] |
Beginning Balance at Dec. 31, 2021 | $ 205,735,523 | $ 58,081 | $ 500,369,444 | $ 0 | $ (294,692,002) | ||
Beginning Balance, Shares at Dec. 31, 2021 | 58,081,215 | ||||||
Stock-based compensation | 1,779,844 | 1,779,844 | |||||
Release of restrictions on Helio founders shares | $ 11 | $ (11) | |||||
Release of restrictions on Helio founders' shares, Shares | 10,890 | ||||||
Issuance of common stock, employee stock purchase plan | 23,324 | $ 7 | 23,317 | ||||
Issuance of common stock, employee stock purchase plan, Shares | 6,860 | ||||||
Issuance of common stock, vested restricted stock awards | 0 | $ 202 | (202) | ||||
Issuance of common stock, vested restricted stock awards, Shares | 202,526 | ||||||
Other comprehensive loss | (61,677) | (61,677) | |||||
Net loss | (16,788,292) | (16,788,292) | |||||
Ending Balance at Mar. 31, 2022 | 190,688,722 | $ 58,301 | 502,172,392 | (61,677) | (311,480,294) | ||
Ending Balance, Shares at Mar. 31, 2022 | 58,301,491 | ||||||
Beginning Balance at Dec. 31, 2022 | 151,008,029 | $ 58,560 | 507,770,045 | (103,938) | (356,716,638) | ||
Beginning Balance, Shares at Dec. 31, 2022 | 58,560,078 | ||||||
Stock-based compensation | 1,694,366 | 1,694,366 | |||||
Issuance of common stock, employee stock purchase plan | 52,559 | $ 17 | 52,542 | ||||
Issuance of common stock, employee stock purchase plan, Shares | 16,272 | ||||||
Issuance of common stock, vested restricted stock awards | 0 | $ 215 | (215) | ||||
Issuance of common stock, vested restricted stock awards, Shares | 215,253 | ||||||
Other comprehensive loss | 103,938 | 103,938 | |||||
Net loss | (15,615,679) | (15,615,679) | |||||
Ending Balance at Mar. 31, 2023 | $ 137,243,213 | $ 58,792 | $ 509,516,738 | $ 0 | $ (372,332,317) | ||
Ending Balance, Shares at Mar. 31, 2023 | 58,791,603 |
Consolidated Statements of Cash
Consolidated Statements of Cash Flows (Unaudited) - USD ($) | 3 Months Ended | |
Mar. 31, 2023 | Mar. 31, 2022 | |
CASH FLOWS FROM OPERATING ACTIVITIES: | ||
Net loss | $ (15,615,679) | $ (16,788,292) |
Adjustments to reconcile net loss to net cash used in operating activities: | ||
Stock-based compensation | 4,190,356 | 1,936,578 |
Non-cash interest expense | 87,160 | 82,798 |
Net amortization of premium on marketable securities | (14,542) | (3,228) |
Depreciation and amortization expense | 66,972 | 62,741 |
Change in assets and liabilities: | ||
Prepaid expenses and other current assets | 3,733,114 | (2,526,926) |
Accounts payable | 296,060 | 1,423,128 |
Accrued expenses and other liabilities | (2,187,259) | 2,940,002 |
Net cash used in operating activities | (9,443,818) | (12,873,199) |
CASH FLOWS FROM INVESTING ACTIVITIES: | ||
Acquisitions of fixed assets | 0 | (16,317) |
Purchases of marketable securities | 0 | (58,015,469) |
Sales and maturities of marketable securities | 30,000,000 | 0 |
Net cash used in investing activities | 30,000,000 | (58,031,786) |
CASH FLOWS FROM FINANCING ACTIVITIES: | ||
Proceeds from employee stock purchase plan | 52,559 | 23,324 |
Net cash provided by financing activities | 52,559 | 23,324 |
NET INCREASE (DECREASE) IN CASH AND CASH EQUIVALENTS | 20,608,741 | (70,881,661) |
CASH AND CASH EQUIVALENTS, BEGINNING OF PERIOD | 144,419,364 | 229,790,989 |
CASH AND CASH EQUIVALENTS, END OF PERIOD | 165,028,105 | 158,909,328 |
SUPPLEMENTAL DISCLOSURES OF CASH FLOW INFORMATION: | ||
Cash paid during the period for interest | 397,396 | $ 322,500 |
SUPPLEMENTAL INFORMATION AND DISCLOSURES OF NONCASH ACTIVITIES: | ||
Common stock issued in connection with Helio Vision, Inc. acquisition milestone | $ 58,792 |
Nature of Business
Nature of Business | 3 Months Ended |
Mar. 31, 2023 | |
Organization, Consolidation and Presentation of Financial Statements [Abstract] | |
Nature of Business | 1. NATURE OF BUSINESS Aldeyra Therapeutics, Inc., together with its wholly-owned subsidiaries (the “Company” or “Aldeyra”), a Delaware corporation, is a clinical-stage biotechnology company devoted to discovering innovative therapies designed to treat immune-mediated diseases. The Company’s principal activities to date include research and development activities along with related general business planning, including raising capital. |
Basis of Presentation
Basis of Presentation | 3 Months Ended |
Mar. 31, 2023 | |
Accounting Policies [Abstract] | |
Basis of Presentation | 2. BASIS OF PRESENTATION The accompanying interim condensed consolidated financial statements and related disclosures are unaudited and have been prepared in accordance with U.S. generally accepted accounting principles (GAAP) for interim financial information and the instructions to Form 10-Q and Regulation S-X. Accordingly, they do not include all the information and footnotes required by GAAP for complete financial statements and should be read in conjunction with the Company’s audited consolidated financial statements and related notes included in the Company’s Annual Report on Form 10-K for the year ended December 31, 2022, which was filed with the Securities and Exchange Commission on March 9, 2023 (2022 Form 10-K). The financial information as of March 31, 2023, and the three months ended March 31, 2023 and 2022, respectively, is unaudited. In the opinion of management, all adjustments, consisting only of normal recurring adjustments considered necessary for the fair presentation of financial position, results of operations, and cash flows at the dates and for the periods presented, have been included. The balance sheet data as of December 31, 2022 was derived from audited consolidated financial statements. The results of the Company’s operations for any interim periods are not necessarily indicative of the results that may be expected for any other interim period or for a full fiscal year. Based on its current operating plan, the Company believes that its cash and cash equivalents as of March 31, 2023, will be sufficient to fund the Company's currently projected operating expenses into the second half of 2024. The Company’s assessment of its liquidity and capital resources includes an estimate of the financial impacts of these changes. The Company has based its projections of operating capital requirements on its current operating plan, which includes several assumptions that may prove to be incorrect, and the Company may use all of its available capital resources sooner than the Company expects. The Company will need to secure additional funding in the future, from one or more equity or debt financings, collaborations, or other sources, in order to carry out all of the Company’s planned research and development activities and regulatory activities; commence or continue ongoing commercialization activities, including manufacturing, sales, marketing and distribution, for any of our product candidates for which the Company may receive marketing approval; or conduct any substantial, additional development requirements requested by the Food and Drug Administration (FDA). Additional funding may not be available to the Company on acceptable terms, or at all. If the Company is unable to secure additional funding, it will be required to significantly decrease the amount of planned expenditures and may be required to cease operations. Curtailment of operations would cause significant delays in the Company’s efforts to develop and introduce its products to market, which is critical to the realization of its business plan and the future operations of the Company. Use of Estimates The preparation of condensed consolidated financial statements in conformity with US GAAP requires management to make estimates and assumptions, including fair value estimates for investments that affect the reported amounts of assets and liabilities, and the disclosure of contingent assets and liabilities at the date of the condensed consolidated financial statements, and the reported amounts of expenses during the reporting periods. The Company’s management evaluates its estimates and assumptions on an ongoing basis. Management’s most significant estimates in the Company’s condensed consolidated financial statements include, but are not limited to, clinical trial accruals, deferred and accrued research and development costs, stock-based compensation, and accounting for income taxes and related valuation allowance. Although these estimates and assumptions are based on the Company’s knowledge of current events and actions it may undertake in the future, actual results may ultimately materially differ from these estimates and assumptions. Summary of Significant Accounting Policies There were no changes to significant accounting policies during the three months ended March 31, 2023, as compared to those identified in the 2022 Form 10-K. Recent Accounting Pronouncements In June 2016, the Financial Accounting Standards Board (FASB) issued Accounting Standards Update (ASU) No. 2016-13, Financial Instruments—Credit Losses (Topic 326): Measurement of Credit Losses on Financial Instruments (ASU 2016-13). ASU 2016-13 requires that credit losses be reported as an allowance using an expected losses model, representing the entity’s current estimate of credit losses expected to be incurred. The accounting guidance currently in effect is based on an incurred loss model. For available-for-sale debt securities with unrealized losses, this standard now requires allowances to be recorded instead of reducing the amortized cost of the investment. The amendments under ASU 2016-13 are effective for interim and annual fiscal periods beginning after December 15, 2022. The Company adopted this standard as of January 1, 2023, and there was no material impact to the Company's financial statements. |
Helio Vision Acquisition
Helio Vision Acquisition | 3 Months Ended |
Mar. 31, 2023 | |
Business Combinations [Abstract] | |
Helio Vision Acquisition | 3. Helio Vision Acquisition On January 28, 2019 (Closing Date), the Company acquired Helio Vision, Inc. (Helio). As a result of the acquisition, the Company initially issued an aggregate of 1,160,444 shares of common stock to the former securityholders and an advisor of Helio. The founders of Helio were issued 568,627 shares and non-founders were issued 591,817 shares. The Helio founders’ shares were subject to vesting based on continued service to the Company through January 28, 2022. The Company recognized the expense associated with the founders’ restricted shares as research and development compensation expense on a straight-line basis as the shares vested over the three-year period. For the three months ended March 31, 2022 the Company recorded $ 0.1 million, of research and development compensation expense, for the founders’ restricted shares. There are no further obligations related to founders’ restricted shares. In January 2021, pursuant to the terms of the acquisition agreement, the Company issued 246,562 shares of its common stock to the former securityholders of Helio (January Shares). In addition, the Company, subject to the conditions of the acquisition agreement, is contingently obligated to make additional payments to the former securityholders of Helio as follows: (a) $ 10.0 million of common stock following approval by the FDA of an NDA for the prevention and/or treatment of proliferative vitreoretinopathy or a substantially similar label prior to the 10th anniversary of the Closing Date; and (b) $ 2.5 million of common stock following FDA approval of an NDA for an indication (other than proliferative vitreoretinopathy or a substantially similar label) prior to the 12th anniversary of the Closing Date (the shares of common stock issuable pursuant to the preceding clauses (a) and (b) are referred to herein as the Milestone Shares), provided that in no event shall the Company be obligated to issue more than an aggregate of 5,248,885 shares of common stock in connection with the Helio acquisition. Additionally, in the event of certain change of control or divestitures by the Company, certain former convertible noteholders of Helio will be entitled to a tax gross-up payment in an amount not to exceed $ 1.0 million in the aggregate. The Company determined that liability accounting is not required for the Milestone Shares under FASB ASC Topic 480, Distinguishing Liabilities from Equity (ASC 480). The Company also determined that the Milestone Shares meet the scope exception as a derivative under FASB ASC Topic 815, Derivatives and Hedging (ASC 815), from inception of the Milestone Shares through March 31, 2023 . Accordingly, the Milestone Shares are evaluated under FASB ASC Topic 450, Contingencies (ASC 450) and the Company will record a liability related to the Milestone Shares if the milestones are achieved, and the obligation to issue the Milestone Shares becomes probable. At such time, the Company will record the cost of the Milestone Shares issued to the Helio founders as a compensation expense and to the Helio non-founders as an in-process research and development (IPR&D) expense if there is no alternative future use. At December 31, 2020, the issuance of the January Shares was considered probable and $ 2.5 million was accrued as contingent consideration payable in stock and the Company recorded $ 1.8 million to IPR&D (Milestone IPR&D), which included a $ 0.5 million income tax benefit, and $ 1.2 million of compensation expense related to the January Shares, which amounted to 246,562 shares and were issued during the quarter ended March 31, 2021. No other milestones related to the remaining Milestone Shares are considered probable of being achieved as of March 31, 2023 . |
Net Loss Per Share
Net Loss Per Share | 3 Months Ended |
Mar. 31, 2023 | |
Earnings Per Share [Abstract] | |
Net Loss Per Share | 4. NET LOSS PER SHARE For the three months ended March 31, 2023 and 2022, diluted weighted average common shares outstanding is equal to basic weighted average common shares due to the Company’s net loss position. The following potentially dilutive securities outstanding have been excluded from the computation of diluted weighted-average shares outstanding, because such securities had an antidilutive impact: Three Months Ended March 31, 2023 2022 Options to purchase common stock 6,432,046 5,972,926 Nonvested restricted stock units 1,208,100 706,446 Total of common stock equivalents 7,640,146 6,679,372 |
Cash, Cash Equivalents and Mark
Cash, Cash Equivalents and Marketable Securities | 3 Months Ended |
Mar. 31, 2023 | |
Cash and Cash Equivalents [Abstract] | |
Cash, Cash Equivalents and Marketable Securities | 5. CASH, CASH EQUIVALENTS, AND MARKETABLE SECURITIES At March 31, 2023, cash and cash equivalents were comprised of: Carrying Unrecognized Unrecognized Estimated Cash and Cash Current Cash $ 125,312,893 $ — $ — $ 125,312,893 $ 125,312,893 $ — Money market funds 39,715,212 — — $ 39,715,212 39,715,212 — Total cash and cash equivalents $ 165,028,105 $ — $ — $ 165,028,105 $ 165,028,105 $ — There were no marketable securities held at March 31, 2023. At December 31, 2022, cash, cash equivalents, and marketable securities were comprised of: Carrying Unrecognized Unrecognized Estimated Cash and Cash Current Cash $ 135,151,081 $ — $ — $ 135,151,081 $ 135,151,081 $ — Money market funds 9,268,283 — — 9,268,283 9,268,283 — Total cash and cash equivalents $ 144,419,364 $ — $ — $ 144,419,364 $ 144,419,364 — U.S. government agency securities 29,985,458 — ( 103,938 ) 29,881,520 — 29,881,520 Available for sale (1) 29,985,458 — ( 103,938 ) 29,881,520 — 29,881,520 Total cash, cash equivalents, and current marketable securities $ 144,419,364 $ 29,881,520 (1) Available for sale securities are reported at fair value with unrealized gains and losses reported net of taxes, if material, in other comprehensive income. The contractual maturities of all available for sale securities were less than one year at December 31, 2022. |
Fair Value Measurements
Fair Value Measurements | 3 Months Ended |
Mar. 31, 2023 | |
Fair Value Disclosures [Abstract] | |
Fair Value Measurements | 6. FAIR VALUE MEASUREMENTS Fair value is defined as the exchange price that would be received for an asset or paid to transfer a liability (an exit price) in the principal or most advantageous market for the asset or liability in an orderly transaction between market participants on the measurement date. Valuation techniques used to measure fair value are performed in a manner to maximize the use of observable inputs and minimize the use of unobservable inputs. ASC 820, Fair Value Measurements , establishes a fair value hierarchy based on three levels of inputs, of which the first two are considered observable and the last unobservable, that may be used to measure fair value, which are the following: Level 1 – Quoted prices in active markets that are accessible at the market date for identical unrestricted assets or liabilities. Level 2 – Inputs other than Level 1 that are observable, either directly or indirectly, such as quoted prices for similar assets or liabilities; quoted prices in markets that are not active; or other inputs for which all significant inputs are observable or can be corroborated by observable market data for substantially the full term of the assets or liabilities. Level 3 – Unobservable inputs that are supported by little or no market activity and that are significant to the fair value of the assets or liabilities. There were no liabilities measured at fair value at March 31, 2023 or December 31, 2022. Money market funds included in cash and cash equivalents in the consolidated balance sheets are valued at quoted market prices in active markets. They are recorded at fair value and considered as Level 1 inputs under the fair value hierarchy. Reverse repurchase agreements and U.S. government agency securities are recorded at fair market value, which are determined based on the most recent observable inputs for similar instruments in active markets or quoted prices for identical or similar instruments in markets that are not active or are directly or indirectly observable. They are considered as Level 2 inputs under the fair value hierarchy. Financial instruments including cash equivalents, clinical trial prepayments to contract research organizations, and accounts payable are carried in the condensed consolidated financial statements at amounts that approximate their fair value based on the short maturities of those instruments. The carrying amount of the Company’s term loan under the Hercules Credit Facility (as defined in Note 9) approximates market rates currently available to the Company. |
Prepaid Expenses and Other Curr
Prepaid Expenses and Other Current Assets | 3 Months Ended |
Mar. 31, 2023 | |
Prepaid Expense and Other Assets, Current [Abstract] | |
Prepaid Expenses and Other Current Assets | 7. PREPAID EXPENSES AND OTHER CURRENT ASSETS Prepaid expenses and other current assets at March 31, 2023 and December 31, 2022 were: March 31, December 31, 2023 2022 Deferred research and development expenses $ 2,539,768 2,605,252 Prepaid insurance expenses 152,860 432,230 Other current receivables 23,685 3,242,026 Miscellaneous prepaid expenses and other current assets 272,802 442,721 Total prepaid expenses and other current assets $ 2,989,115 $ 6,722,229 |
Accrued Expenses
Accrued Expenses | 3 Months Ended |
Mar. 31, 2023 | |
Payables and Accruals [Abstract] | |
Accrued Expenses | 8. ACCRUED EXPENSES Accrued expenses at March 31, 2023 and December 31, 2022 were: March 31, December 31, 2023 2022 Accrued compensation $ 5,510,667 $ 3,821,904 Accrued research and development expenses 6,360,103 8,476,422 Accrued other expenses 2,562,909 1,767,559 Total accrued expenses $ 14,433,679 $ 14,065,885 |
Credit Facility
Credit Facility | 3 Months Ended |
Mar. 31, 2023 | |
Debt Disclosure [Abstract] | |
Credit Facility | 9. CREDIT FACILITY The Company’s current and long-term debt obligation consists of amounts the Company is obligated to repay under its credit facility with Hercules Capital, Inc. (Hercules). In March 2019, the Company entered into a Loan and Security Agreement (Loan and Security Agreement or Hercules Credit Facility) with Hercules and several banks and other financial institutions or entities, from time-to-time parties thereto (collectively, referred to herein as Lender), providing for a term loan of up to $ 60.0 million, subject to the satisfaction of certain conditions contained therein, that is secured by a lien covering all of the Company’s assets, other than the Company’s intellectual property. The Loan and Security Agreement provided for (i) an initial term loan advance of up to $ 5.0 million at the Company’s option, which expired unutilized on April 15, 2019; (ii) three additional term loan advances of up to $ 15.0 million each, at the Company’s option, available to the Company upon the occurrence of certain pre-specified funding conditions prior to September 30, 2019 (2019 Tranche), March 31, 2020 (2020 Tranche), and March 31, 2021 (2021 Tranche); and (iii) a final additional term loan advance (Fourth Loan Tranche) of up to $ 10.0 million prior to December 31, 2021, at the Company’s option, subject to approval by the Lender’s investment committee. The 2019 Tranche was drawn down in full by the Company in September 2019 and the 2020 Tranche and 2021 Tranche expired unutilized prior to the Company satisfying the funding conditions for such tranche. On April 20, 2021, the Company entered into the First Amendment to the Loan and Security Agreement (First Amendment). The First Amendment, among other things, (i) increased the Fourth Loan Tranche from $ 10.0 million to $ 20.0 million and extended the deadline for drawing down the Fourth Loan Tranche to July 1, 2022; (ii) lowered the variable per annum rate of interest on borrowings under the Loan and Security Agreement from the greater of (a) 9.10 % and (b) the prime rate (as reported in the Wall Street Journal or any successor publication thereto) plus 3.10 % to the greater of (x) the Prime Rate (as defined therein) plus 3.10% or (y) 8.60%; (iii) extended the expiration of the period in which interest-only payments on borrowings under the Loan and Security Agreement are required from May 1, 2021 to July 1, 2022; and (iv) following the satisfaction of certain conditions, which conditions were satisfied in April 2021, further extended the expiration of the interest-only period and the deadline for drawing down the Fourth Loan Tranche to May 1, 2023 . Repayment of the aggregate outstanding principal balance of the term loan, in monthly installments, commences upon expiration of the interest-only period and continues through October 1, 2023 (Maturity Date). The First Amendment was determined to be a modification in accordance with FASB ASC Topic 470, Debt and did not result in extinguishment. On December 22, 2022, the Company entered into the Second Amendment to the Loan and Security Agreement (Second Amendment), which became effective as of December 31, 2022 (Second Amendment Effective Date). The Second Amendment, among other things, (i) extended the expiration of the period in which interest-only payments on borrowings under the Loan and Security Agreement are made from May 1, 2023 to May 1, 2024; (ii) extended the Maturity Date from October 1, 2023 to October 1, 2024; (iii) extended the availability of the Fourth Loan Tranche commitment of $ 20 million from May 1, 2023 to May 1, 2024 ; and (iv) amended the Prepayment Charge (as defined therein) to equal 0.75 % of the amount prepaid during the 12-month period following the Second Amendment Effective Date, and 0 % thereafter. The ability to draw the Fourth Loan Tranche remains conditioned on approval by the Lenders’ investment committee. In addition, a supplemental end of term charge of $ 292,500 (Supplemental End of Term Charge) shall be due on the earlier of (A) the Maturity Date, as amended, or (B) repayment of the aggregate amount of advances under the Loan and Security Agreement. The existing end of term charge of $ 1,042,500 (End of Term Charge) remains due on the earlier of (A) October 1, 2023 or (B) repayment of the aggregate amount of advances under the Loan and Security Agreement. The Second Amendment was determined to be a modification in accordance with FASB ASC Topic, Debt and did not result in extinguishment. In connection with the Hercules Credit Facility, the Company incurred a commitment charge of $ 25,000 , transaction costs of $ 273,186 , a fee of $ 375,000 upon closing, and will be required to pay the End of Term Charge and Supplemental End of Term Charge. The fees and transaction costs are amortized to interest expense from 2019 through the Maturity Date using the effective interest method. The End of Term Charge is amortized to interest expense from 2019 through October 2023, and the Supplemental End of Term Charge is amortized to interest expense from December 2022 through the Maturity Date, both using the effective interest method. The effective interest rate was 13.7 % at March 31, 2023 . At the Company’s option, the Company may elect to prepay all, but not less than all, of the outstanding term loan by paying the entire principal balance and all accrued and unpaid interest thereon plus all fees and other amounts due under the Loan and Security Agreement as of the date of such prepayment, including a prepayment charge equal to 0.75 % of the principal amount being prepaid during the 12-month period following the Second Amendment Effective Date, and 0 % thereafter. Following the effective time of the First Amendment and the Second Amendment and as of March 31, 2023 an aggregate of $ 35.0 million, subject to the terms and conditions of the Loan and Security Agreement, may be made available to the Company for borrowing, $ 15.0 million of which was funded prior to the date of the First Amendment. Long-term debt consisted of the following: March 31, December 31, 2023 2022 Term loan payable $ 15,000,000 $ 15,000,000 End of term charge 974,886 911,763 Unamortized debt issuance costs ( 52,873 ) ( 76,910 ) Less: current portion ( 954,325 ) ( 911,763 ) Total long-term debt $ 14,967,688 $ 14,923,090 Future principal payments, including the End of Term Charge, are as follows for the years ending December 31: 2023 $ 1,042,500 2024 15,292,500 Total $ 16,335,000 The Loan and Security Agreement also contains certain events of default, representations, warranties and non-financial covenants of the Company. As of March 31, 2023 , the Company was in compliance with all covenants of the Hercules Credit Facility in all material respects. In addition, subject to the terms of the Loan and Security Agreement, the Company granted the Lender the right to purchase up to an aggregate of $ 2.0 million of the Company’s equity securities, or instruments exercisable for or convertible into equity securities, sold to investors in financings upon the same terms and conditions afforded to such other investors. |
Stockholders' Equity
Stockholders' Equity | 3 Months Ended |
Mar. 31, 2023 | |
Equity [Abstract] | |
Stockholders Equity | 10. STOCKHOLDERS’ EQUITY In March 2021, the Company entered into an Open Market Sales Agreement SM with Jefferies LLC, as sales agent (2021 Jefferies Sales Agreement). Pursuant to the 2021 Jefferies Sales Agreement, the Company may offer and sell, from time to time through Jefferies, shares of common stock providing for aggregate sales proceeds of up to $ 100.0 million. The Company has no obligation to sell any shares under the 2021 Jefferies Sales Agreement, and could at any time suspend solicitations and offers under the 2021 Jefferies Sales Agreement. As of March 31, 2023 , no sales had been made pursuant to the 2021 Jefferies Sales Agreement. |
Income Taxes
Income Taxes | 3 Months Ended |
Mar. 31, 2023 | |
Income Tax Disclosure [Abstract] | |
Income Taxes | 11. INCOME TAXES No current or deferred tax provision expenses for federal and state income taxes have been recorded as the Company has incurred losses since inception for tax purposes. Deferred income taxes reflect the net tax effects of temporary differences between the carrying amounts of assets and liabilities for financial reporting purposes and the amounts used for income tax purposes. In assessing the realizability of net deferred taxes in accordance with Accounting Standards Codification (ASC) 740, Income Taxes (ASC 740), the Company considers whether it is more likely than not that some portion or all the deferred tax assets will not be realized. Based on the weight of available evidence, primarily the incurrence of net losses since inception, anticipated net losses in the near future, reversals of existing temporary differences, and expiration of various federal and state attributes, the Company does not consider it more likely than not that some or all of the net deferred taxes will be realized. Accordingly, a 100 % valuation allowance has been applied against net deferred tax assets. Under Section 382 of the Internal Revenue Code of 1986, as amended (Section 382), a corporation that undergoes an “ownership change” is subject to limitations on its ability to utilize its pre-change net operating losses (NOLs) and certain other tax assets (tax attributes) to offset future taxable income. In general, an ownership change occurs if the aggregate stock ownership of certain stockholders increases by more than 50 percentage points over such stockholders’ lowest percentage ownership during the testing period (generally three years). Transactions involving the Company’s common stock, within the testing period, even those outside the Company’s control, such as purchases or sales by investors, within the testing period could result in an ownership change. A limitation on the Company’s ability to utilize some or all its NOLs or credits could have a material adverse effect on the Company’s results of operations and cash flows. Prior to December 31, 2021, the Company believes it underwent four ownership changes. However, management believes that its aggregate Section 382 limitation (including the additional limitation for recognized “built-in-gains”) is sufficient so that no current impairment of its pre-ownership change tax attributes is required. The Company does not believe an ownership change has occurred from December 31, 2021, through March 31, 2023, based on a review of its equity history during that period. Any future ownership changes, including those resulting from the Company’s future financing activities, may cause its existing tax attributes to incur additional limitations. As of March 31, 2023, the Company is subject to tax in the U.S. (Federal and Massachusetts). The Company is open to examination for the tax years ended December 31, 2022, 2021, 2020, and 2019. In addition, any loss years remain open to the extent that losses are available for carryover to future years. The Company accounts for uncertain tax positions pursuant to ASC 740-10 which prescribes a recognition threshold and measurement process for financial statement recognition of uncertain tax positions taken or expected to be taken in a tax return. If the tax position meets this threshold, the benefit to be recognized is measured as the tax benefit having the highest likelihood of being realized upon ultimate settlement with the taxing authority. Accordingly, in the provision for income taxes, the Company recognizes interest accrued related to unrecognized tax benefits and penalties; however, management is currently unaware of any uncertain tax positions. As a result, the Company does not have any liabilities recorded including interest or penalties for uncertain tax positions. The Inflation Reduction Act (IRA) was enacted on August 16, 2022. Based on review of the IRA, the Company does not expect any impact to its tax provision. In particular, the Company does not expect to pay Corporate Alternative Minimum Tax (CAMT) in the next few years based on its projected losses. The IRA introduces a 15% CAMT for corporations whose average annual adjusted financial statement income for any consecutive three-tax-year period preceding the tax year exceeds $1 billion starting in 2023. |
Stock-Based Compensation
Stock-Based Compensation | 3 Months Ended |
Mar. 31, 2023 | |
Share-Based Payment Arrangement [Abstract] | |
Stock-Based Compensation | 12. STOCK-BASED COMPENSATION The Company has two equity incentive plans that provide for the granting of stock options, restricted stock, stock appreciation rights, stock units, cash awards, and cash settled bonus awards (CSBU) to certain employees, members of the board of directors, and consultants of the Company with a generally prescribed contractual term of ten years . As of March 31, 2023, there were 6,872,672 shares of common stock available for grant under the Company’s equity incentive plans. In 2019, 2020, and 2022 the Company granted cash awards under its Management Cash Incentive Plan, as amended. The cash awards vest in four annual installments from the date of grant based on continued service, and entitle the employees to receive a cash payment, on the earlier of (i) four years from the date of grant or (ii) a change of control, equal in value to the amount by which the then value of the Company’s common stock exceeds the base value. As of March 31, 2023, $ 2.6 million was accrued as compensation expense for vested cash awards. There was no unrecognized expense as of March 31, 2023. In 2022, the Company granted performance CSBUs under its Management Cash Incentive Plan, as amended. Subject to and conditioned upon the acceptance by the FDA of the Company's submission of an NDA for reproxalap (Performance Criteria), the awards will vest in four annual installments from the date of grant based on continued service, and entitle the employees to receive a cash payment for each vested CSBU, on the earlier of (i) four years from the date of grant or (ii) a change of control, equal in value of the closing price per share of the Company's common stock on the Nasdaq Capital Market on the payment date. As of March 31, 2023, $ 2.5 million was accrued as compensation expense for CSBUs as the Performance Criteria was met in February 2023. There was no unrecognized expense as of March 31, 2023. The Company recognizes stock-based compensation expense over the requisite service period. The Company's share-based awards are accounted for as equity instruments, except for cash awards and CSBUs, which are accounted for as liabilities. The amounts included in the consolidated statements of operations relating to stock-based compensation associated with the two equity incentive plans, cash awards, CSBUs, and Helio foun ders’ shares are as follows: Three Months Ended March 31, 2023 2022 Research and development expenses $ 2,191,368 $ 845,667 General and administrative expenses 1,998,988 1,090,911 Total stock-based compensation expense $ 4,190,356 $ 1,936,578 Stock Options The table below summarizes activity relating to stock options under the incentive plans for the three months ended March 31, 2023: Number of Weighted Weighted Aggregate Outstanding at December 31, 2022 5,403,982 $ 5.90 6.56 $ 10,506,953 Granted 1,028,064 $ 6.76 Outstanding at March 31, 2023 6,432,046 $ 6.04 6.88 $ 26,374,880 Exercisable at March 31, 2023 3,771,769 $ 6.12 5.30 $ 15,217,207 (a) The aggregate intrinsic value in this table was calculated on the positive difference, if any, between the closing price per share of the Company’s common stock on March 31, 2023 of $ 9.93 and the per share exercise price of the underlying options. As of March 31, 2023, unamortized stock-based compensation for stock options outstanding was $ 10.0 million and is expected to be recognized over a weighted average period of 2.93 years. Total unrecognized compensation cost will be adjusted for future forfeitures, if necessary. Restricted Stock Units The table below summarizes activity relating to restricted stock units (RSUs) for the three months ended March 31, 2023: Number Weighted-Average Grant Date Fair Value Outstanding at December 31, 2022 1,184,603 4.95 Granted 238,750 6.76 Vested ( 215,253 ) 5.72 Outstanding at March 31, 2023 1,208,100 5.17 The weighted-average grant date fair value of RSUs granted was $ 6.76 per share for the three months ended March 31, 2023 . The total grant date fair value of RSUs vested was $ 1.2 million for the three months ended March 31, 2023. As of March 31, 2023, the outstanding RSUs had unamortized stock-based compensation of $ 5.4 million with a weighted-average remaining recognition period of 3.17 years and an aggregate intrinsic value of $ 12.0 million . Employee Stock Purchase Plan At March 31, 2023, the Company had 2,355,322 shares available for issuance under the 2016 Employee Stock Purchase Plan (2016 ESPP). A summary of the weighted-average grant-date fair value, and total stock-based compensation expense recognized related to the 2016 ESPP are as follows: Three Months Ended March 31, 2023 2022 Weighted-average grant-date fair value per share $ 2.70 $ 1.65 Total stock-based compensation expense $ 17,040 $ 22,468 |
Leases
Leases | 3 Months Ended |
Mar. 31, 2023 | |
Leases [Abstract] | |
Leases | 13. LEASES The Company currently leases an office used to conduct business. The exercise of lease renewal options is at the Company’s discretion and the renewal to extend the lease terms are not included in the Company’s Right-Of-Use assets and lease liabilities as they are not reasonably certain of exercise. The Company regularly evaluates the renewal options and when they are reasonably certain of exercise, the Company includes the renewal period in its lease term. In December 2022, the Company exercised its option to extend the lease through December 31, 2023. As the Company’s lease does not provide an implicit rate, the Company uses its incremental borrowing rate based on the information available at the lease commencement date in determining the present value of the lease payments. As of March 31, 2023, the Company maintained an unamortized Right-Of-Use asset with a corresponding operating lease liability of approximately $ 0.2 million based on the present value of the minimum rental payments in accordance with ASC Topic 842, Leases . The weighted average discount rate used for leases as of March 31, 2023 is 9.1 %. The weighted average remaining lease term as of March 31, 2023 was 0.75 years. The operating lease expense for the three months ended March 31, 2023 was $ 65.5 thousand . Maturities and balance sheet presentation of the Company’s lease liabilities for all operating leases as of March 31, 2023 is as follows: 2023 remaining total lease payments $ 197,540 Less: effect of discounting ( 7,338 ) Present value of lease liabilities $ 190,202 Current operating lease liabilities $ 190,202 Total $ 190,202 The Company’s gross future minimum payments under all non-cancelable operating leases as of March 31, 2023, are: Total 2023 2024 2025 2026 Operating lease obligations $ 197,540 $ 197,540 $ — $ — $ — |
Commitments and Contingencies
Commitments and Contingencies | 3 Months Ended |
Mar. 31, 2023 | |
Commitments and Contingencies Disclosure [Abstract] | |
Commitments and Contingencies | 14. COMMITMENTS AND CONTINGENCIES Guarantees and Indemnifications As permitted under Delaware law, the Company indemnifies its officers and directors for certain events or occurrences while the officer or director is, or was, serving at the Company’s request in such capacity. The term of the indemnification is for the officer’s or director’s lifetime. Through March 31, 2023 , the Company had not experienced any losses related to these indemnification obligations and no material claims were outstanding. The Company does not expect significant claims related to these indemnification obligations, and consequently, concluded that the fair value of these obligations is negligible, and no related reserves were established. In-License Agreements MEEI Agreement The Company is developing ADX-2191 pursuant to an Exclusive License Agreement with Massachusetts Eye and Ear Infirmary (MEEI) originally entered into in July 2016 between MEEI and Helio Vision, Inc., as amended, (MEEI Agreement). The Company assumed the MEEI Agreement in connection with its 2019 acquisition of Helio Vision. In consideration for the rights licensed under the MEEI Agreement, Helio Vision issued MEEI a number of shares of its preferred stock and Helio Vision agreed to pay non-creditable non-refundable license maintenance fees to MEEI of $ 15,000 on each of the second and third anniversary of the MEEI Agreement, $ 25,000 on each of the fourth and fifth anniversary of the MEEI Agreement and $ 35,000 on the sixth and each subsequent anniversary of the MEEI Agreement during the term of such agreement. In addition, Helio Vision was obligated to make future sales-dependent milestone payments to MEEI of up to the low seven figures in the aggregate, as well as royalty payments to MEEI at a rate which, as a percentage of net sales, is in the low single digits for products that incorporate or use the MEEI Patent Rights in the United States and as a percentage in the low single digits for products that incorporate or use the MEEI Patent Rights outside the United States. The Company is also obligated under the MEEI Agreement to pay MEEI a percentage of certain sublicense revenue that it receives in connection with entering into any sublicensing arrangements with any third parties, at a percentage rate which tiers downward from low-double digits to mid-single digits based on the date of the sublicense. Following the Company’s acquisition of Helio Vision, the Company became obligated to make any future payments owed under the MEEI Agreement. There is no additional equity consideration issuable under the MEEI Agreement. The MEEI Agreement will remain in effect until the expiration date of the last to expire patent licensed under the MEEI Agreement. The Company may terminate the MEEI Agreement with timely written notice to MEEI. MEEI has the right to terminate the MEEI Agreement if it, subject to certain specified cure periods, ceases all business operations with respect to licensed products, fails to pay amounts due under the MEEI Agreement, fail to comply with certain due diligence obligations, defaults in our obligation to maintain insurance, one of our officers is convicted of a felony relating to the manufacture, use, sale or importation of licensed products, we materially breach any provisions of the MEEI Agreement or in the event of its insolvency or bankruptcy. In the event of an early termination of the MEEI Agreement, all rights licensed and developed by the Company under the MEEI Agreement may revert back to MEEI. The Company has agreed to indemnify MEEI for certain claims that may arise under the MEEI Agreement. Litigation From time to time, the Company is party to legal proceedings. There are none deemed to be material at this time. Accordingly, the Company has not accrued any liabilities in its unaudited condensed consolidated financial statements related to proceedings. |
Basis of Presentation (Policies
Basis of Presentation (Policies) | 3 Months Ended |
Mar. 31, 2023 | |
Accounting Policies [Abstract] | |
Use of Estimates | Use of Estimates The preparation of condensed consolidated financial statements in conformity with US GAAP requires management to make estimates and assumptions, including fair value estimates for investments that affect the reported amounts of assets and liabilities, and the disclosure of contingent assets and liabilities at the date of the condensed consolidated financial statements, and the reported amounts of expenses during the reporting periods. The Company’s management evaluates its estimates and assumptions on an ongoing basis. Management’s most significant estimates in the Company’s condensed consolidated financial statements include, but are not limited to, clinical trial accruals, deferred and accrued research and development costs, stock-based compensation, and accounting for income taxes and related valuation allowance. Although these estimates and assumptions are based on the Company’s knowledge of current events and actions it may undertake in the future, actual results may ultimately materially differ from these estimates and assumptions. |
Summary of Significant Accounting Policies | Summary of Significant Accounting Policies There were no changes to significant accounting policies during the three months ended March 31, 2023, as compared to those identified in the 2022 Form 10-K. |
Recent Accounting Pronouncements | Recent Accounting Pronouncements In June 2016, the Financial Accounting Standards Board (FASB) issued Accounting Standards Update (ASU) No. 2016-13, Financial Instruments—Credit Losses (Topic 326): Measurement of Credit Losses on Financial Instruments (ASU 2016-13). ASU 2016-13 requires that credit losses be reported as an allowance using an expected losses model, representing the entity’s current estimate of credit losses expected to be incurred. The accounting guidance currently in effect is based on an incurred loss model. For available-for-sale debt securities with unrealized losses, this standard now requires allowances to be recorded instead of reducing the amortized cost of the investment. The amendments under ASU 2016-13 are effective for interim and annual fiscal periods beginning after December 15, 2022. The Company adopted this standard as of January 1, 2023, and there was no material impact to the Company's financial statements. |
Net Loss Per Share (Tables)
Net Loss Per Share (Tables) | 3 Months Ended |
Mar. 31, 2023 | |
Earnings Per Share [Abstract] | |
Computation of Diluted Weighted-Average Shares Outstanding | The following potentially dilutive securities outstanding have been excluded from the computation of diluted weighted-average shares outstanding, because such securities had an antidilutive impact: Three Months Ended March 31, 2023 2022 Options to purchase common stock 6,432,046 5,972,926 Nonvested restricted stock units 1,208,100 706,446 Total of common stock equivalents 7,640,146 6,679,372 |
Cash, Cash Equivalents and Ma_2
Cash, Cash Equivalents and Marketable Securities (Tables) | 3 Months Ended |
Mar. 31, 2023 | |
Cash and Cash Equivalents [Abstract] | |
Schedule of Cash, and Cash Equivalents | At March 31, 2023, cash and cash equivalents were comprised of: Carrying Unrecognized Unrecognized Estimated Cash and Cash Current Cash $ 125,312,893 $ — $ — $ 125,312,893 $ 125,312,893 $ — Money market funds 39,715,212 — — $ 39,715,212 39,715,212 — Total cash and cash equivalents $ 165,028,105 $ — $ — $ 165,028,105 $ 165,028,105 $ — There were no marketable securities held at March 31, 2023. At December 31, 2022, cash, cash equivalents, and marketable securities were comprised of: Carrying Unrecognized Unrecognized Estimated Cash and Cash Current Cash $ 135,151,081 $ — $ — $ 135,151,081 $ 135,151,081 $ — Money market funds 9,268,283 — — 9,268,283 9,268,283 — Total cash and cash equivalents $ 144,419,364 $ — $ — $ 144,419,364 $ 144,419,364 — U.S. government agency securities 29,985,458 — ( 103,938 ) 29,881,520 — 29,881,520 Available for sale (1) 29,985,458 — ( 103,938 ) 29,881,520 — 29,881,520 Total cash, cash equivalents, and current marketable securities $ 144,419,364 $ 29,881,520 (1) Available for sale securities are reported at fair value with unrealized gains and losses reported net of taxes, if material, in other comprehensive income. |
Prepaid Expenses and Other Cu_2
Prepaid Expenses and Other Current Assets (Tables) | 3 Months Ended |
Mar. 31, 2023 | |
Prepaid Expense and Other Assets, Current [Abstract] | |
Schedule of Prepaid Expenses and Other Current Assets | Prepaid expenses and other current assets at March 31, 2023 and December 31, 2022 were: March 31, December 31, 2023 2022 Deferred research and development expenses $ 2,539,768 2,605,252 Prepaid insurance expenses 152,860 432,230 Other current receivables 23,685 3,242,026 Miscellaneous prepaid expenses and other current assets 272,802 442,721 Total prepaid expenses and other current assets $ 2,989,115 $ 6,722,229 |
Accrued Expenses (Tables)
Accrued Expenses (Tables) | 3 Months Ended |
Mar. 31, 2023 | |
Payables and Accruals [Abstract] | |
Schedule of Accrued Expenses | Accrued expenses at March 31, 2023 and December 31, 2022 were: March 31, December 31, 2023 2022 Accrued compensation $ 5,510,667 $ 3,821,904 Accrued research and development expenses 6,360,103 8,476,422 Accrued other expenses 2,562,909 1,767,559 Total accrued expenses $ 14,433,679 $ 14,065,885 |
Credit Facility (Tables)
Credit Facility (Tables) | 3 Months Ended |
Mar. 31, 2023 | |
Debt Disclosure [Abstract] | |
Schedule of Long-Term Debt | Long-term debt consisted of the following: March 31, December 31, 2023 2022 Term loan payable $ 15,000,000 $ 15,000,000 End of term charge 974,886 911,763 Unamortized debt issuance costs ( 52,873 ) ( 76,910 ) Less: current portion ( 954,325 ) ( 911,763 ) Total long-term debt $ 14,967,688 $ 14,923,090 |
Schedule of Principal Payments Including End of Term Charges | Future principal payments, including the End of Term Charge, are as follows for the years ending December 31: 2023 $ 1,042,500 2024 15,292,500 Total $ 16,335,000 |
Stock-Based Compensation (Table
Stock-Based Compensation (Tables) | 3 Months Ended |
Mar. 31, 2023 | |
Share-Based Payment Arrangement [Abstract] | |
Schedule of Stock-Based Compensation Expense | The amounts included in the consolidated statements of operations relating to stock-based compensation associated with the two equity incentive plans, cash awards, CSBUs, and Helio foun ders’ shares are as follows: Three Months Ended March 31, 2023 2022 Research and development expenses $ 2,191,368 $ 845,667 General and administrative expenses 1,998,988 1,090,911 Total stock-based compensation expense $ 4,190,356 $ 1,936,578 |
Summary of Activity Relating to Stock Options | The table below summarizes activity relating to stock options under the incentive plans for the three months ended March 31, 2023: Number of Weighted Weighted Aggregate Outstanding at December 31, 2022 5,403,982 $ 5.90 6.56 $ 10,506,953 Granted 1,028,064 $ 6.76 Outstanding at March 31, 2023 6,432,046 $ 6.04 6.88 $ 26,374,880 Exercisable at March 31, 2023 3,771,769 $ 6.12 5.30 $ 15,217,207 |
Summary of Activity Relating to Restricted Stock Units | The table below summarizes activity relating to restricted stock units (RSUs) for the three months ended March 31, 2023: Number Weighted-Average Grant Date Fair Value Outstanding at December 31, 2022 1,184,603 4.95 Granted 238,750 6.76 Vested ( 215,253 ) 5.72 Outstanding at March 31, 2023 1,208,100 5.17 |
Summary of Employee Stock Purchase Plan Activity | A summary of the weighted-average grant-date fair value, and total stock-based compensation expense recognized related to the 2016 ESPP are as follows: Three Months Ended March 31, 2023 2022 Weighted-average grant-date fair value per share $ 2.70 $ 1.65 Total stock-based compensation expense $ 17,040 $ 22,468 |
Leases (Tables)
Leases (Tables) | 3 Months Ended |
Mar. 31, 2023 | |
Leases [Abstract] | |
Schedule of Maturities and Balance Sheet Presentation of Lease Liabilities | Maturities and balance sheet presentation of the Company’s lease liabilities for all operating leases as of March 31, 2023 is as follows: 2023 remaining total lease payments $ 197,540 Less: effect of discounting ( 7,338 ) Present value of lease liabilities $ 190,202 Current operating lease liabilities $ 190,202 Total $ 190,202 The Company’s gross future minimum payments under all non-cancelable operating leases as of March 31, 2023, are: Total 2023 2024 2025 2026 Operating lease obligations $ 197,540 $ 197,540 $ — $ — $ — |
Helio Vision Acquisition - Addi
Helio Vision Acquisition - Additional Information (Detail) - USD ($) | 1 Months Ended | 3 Months Ended | 12 Months Ended | |||
Jan. 28, 2019 | Jan. 31, 2021 | Mar. 31, 2023 | Mar. 31, 2022 | Mar. 31, 2021 | Dec. 31, 2020 | |
Business Acquisition [Line Items] | ||||||
Allocated Share Based Compensation Expense | $ 4,190,356 | $ 1,936,578 | ||||
Research and Development Expenses [Member] | ||||||
Business Acquisition [Line Items] | ||||||
Allocated Share Based Compensation Expense | $ 2,191,368 | 845,667 | ||||
Helio Vision Inc [Member] | ||||||
Business Acquisition [Line Items] | ||||||
Business combination, stock issued | 1,160,444 | 246,562 | ||||
Contingent consideration payable in stock | $ 2,500,000 | |||||
Income tax benefit | 500,000 | |||||
Helio Vision Inc [Member] | Common Stock after FDA Approval prior to 10th Anniversary [Member] | ||||||
Business Acquisition [Line Items] | ||||||
Business combination, contingent consideration liability | $ 10,000,000 | |||||
Helio Vision Inc [Member] | Common Stock after FDA Approval Prior to 12th Anniversary [Member] | ||||||
Business Acquisition [Line Items] | ||||||
Business combination, contingent consideration liability | $ 2,500,000 | |||||
Helio Vision Inc [Member] | Common Stock after FDA Approval Prior to 12th Anniversary [Member] | Maximum [Member] | ||||||
Business Acquisition [Line Items] | ||||||
Business combination, contingent consideration stock to be issued | 5,248,885 | |||||
Helio Vision Inc [Member] | Tax Gross-up Payment in Event of Change of Control or Divesture [Member] | Maximum [Member] | ||||||
Business Acquisition [Line Items] | ||||||
Business combination, contingent consideration liability | $ 1,000,000 | |||||
Helio Vision Inc [Member] | Founders [Member] | ||||||
Business Acquisition [Line Items] | ||||||
Business combination, stock issued | 568,627 | |||||
Helio Vision Inc [Member] | Founders [Member] | Restricted Stock [Member] | ||||||
Business Acquisition [Line Items] | ||||||
Share-based compensation award, vesting period | 3 years | |||||
Helio Vision Inc [Member] | Founders [Member] | Research and Development Expenses [Member] | Restricted Stock [Member] | ||||||
Business Acquisition [Line Items] | ||||||
Allocated Share Based Compensation Expense | $ 100,000 | |||||
Helio Vision Inc [Member] | Non Founders [Member] | ||||||
Business Acquisition [Line Items] | ||||||
Business combination, stock issued | 591,817 | |||||
Helio Vision Inc [Member] | Milestone [Member] | ||||||
Business Acquisition [Line Items] | ||||||
Business combination, stock issued | 246,562 | |||||
Helio Vision Inc [Member] | Milestone [Member] | Research and Development Expenses [Member] | Restricted Stock [Member] | ||||||
Business Acquisition [Line Items] | ||||||
Allocated Share Based Compensation Expense | 1,200,000 | |||||
Expense related to the Milestone IPR&D | $ 1,800,000 |
Net Loss Per Share - Computatio
Net Loss Per Share - Computation of Diluted Weighted-Average Shares Outstanding (Detail) - shares | 3 Months Ended | |
Mar. 31, 2023 | Mar. 31, 2022 | |
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] | ||
Total of common stock equivalents | 7,640,146 | 6,679,372 |
Options to Purchase Common Stock [Member] | ||
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] | ||
Total of common stock equivalents | 6,432,046 | 5,972,926 |
Restricted Stock Units [Member] | ||
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] | ||
Total of common stock equivalents | 1,208,100 | 706,446 |
Cash, Cash Equivalents and Ma_3
Cash, Cash Equivalents and Marketable Securities - Schedule of Cash, and Cash Equivalents (Detail) - USD ($) | 12 Months Ended | |
Dec. 31, 2022 | Mar. 31, 2023 | |
Cash Cash Equivalents And Marketable Securities [Line Items] | ||
Total Cash and cash equivalents | $ 144,419,364 | |
Cash and Cash Equivalents | 29,881,520 | $ 0 |
Current Marketable Securities | 29,881,520 | |
Available for sale carrying Amount | 29,985,458 | |
Available for sale unrecognized loss | (103,938) | |
Available for sale fair value disclosure | 29,881,520 | |
U.S. government agency securities [Member] | ||
Cash Cash Equivalents And Marketable Securities [Line Items] | ||
Current Marketable Securities | 29,881,520 | |
Available for sale carrying Amount | 29,985,458 | |
Available for sale unrecognized loss | (103,938) | |
Available for sale fair value disclosure | 29,881,520 | |
Cash [Member] | ||
Cash Cash Equivalents And Marketable Securities [Line Items] | ||
Cash | 135,151,081 | 125,312,893 |
Estimated Fair Value | 135,151,081 | 125,312,893 |
Cash and Cash Equivalents | 135,151,081 | 125,312,893 |
Money Market Funds [Member] | ||
Cash Cash Equivalents And Marketable Securities [Line Items] | ||
Money market funds | 9,268,283 | 39,715,212 |
Estimated Fair Value | 9,268,283 | 39,715,212 |
Cash and Cash Equivalents | 9,268,283 | 39,715,212 |
Total Cash and cash equivalents [Member] | ||
Cash Cash Equivalents And Marketable Securities [Line Items] | ||
Total Cash and cash equivalents | 144,419,364 | 165,028,105 |
Estimated Fair Value | 144,419,364 | 165,028,105 |
Cash and Cash Equivalents | 144,419,364 | $ 165,028,105 |
Available for sale [Member] | ||
Cash Cash Equivalents And Marketable Securities [Line Items] | ||
Current Marketable Securities | $ 29,881,520 |
Cash, Cash Equivalents and Ma_4
Cash, Cash Equivalents and Marketable Securities - Additional Information (Detail) | Mar. 31, 2023 USD ($) |
Cash and Cash Equivalents [Abstract] | |
Marketable Securities | $ 0 |
Fair Value Measurements - Addit
Fair Value Measurements - Additional Information (Detail) - USD ($) | Mar. 31, 2023 | Dec. 31, 2022 |
Fair Value Disclosures [Abstract] | ||
Liabilities measured at fair value on a recurring basis | $ 0 | $ 0 |
Prepaid Expenses and Other Cu_3
Prepaid Expenses and Other Current Assets - Schedule of Prepaid Expenses and Other Current Assets (Details) - USD ($) | Mar. 31, 2023 | Dec. 31, 2022 |
Prepaid Expense and Other Assets, Current [Abstract] | ||
Deferred research and development expenses | $ 2,539,768 | $ 2,605,252 |
Prepaid insurance expenses | 152,860 | 432,230 |
Other current receivables | 23,685 | 3,242,026 |
Miscellaneous prepaid expenses and other current assets | 272,802 | 442,721 |
Total prepaid expenses and other current assets | $ 2,989,115 | $ 6,722,229 |
Accrued Expenses - Schedule of
Accrued Expenses - Schedule of Accrued Expenses (Detail) - USD ($) | Mar. 31, 2023 | Dec. 31, 2022 |
Payables and Accruals [Abstract] | ||
Accrued compensation | $ 5,510,667 | $ 3,821,904 |
Accrued research and development | 6,360,103 | 8,476,422 |
Accrued other expenses | 2,562,909 | 1,767,559 |
Accrued expenses | $ 14,433,679 | $ 14,065,885 |
Credit Facility - Additional In
Credit Facility - Additional Information (Detail) - USD ($) | 3 Months Ended | |||
Dec. 22, 2022 | Apr. 20, 2021 | Mar. 31, 2023 | Dec. 31, 2022 | |
Line Of Credit Facility [Line Items] | ||||
Long-Term Debt | $ 16,335,000 | |||
Hercules Credit Facility [Member] | ||||
Line Of Credit Facility [Line Items] | ||||
Credit facility amount | $ 35,000,000 | $ 60,000,000 | ||
Debt instrument annual interest rate | 9.10% | |||
Interest payment period | May 01, 2021 | |||
Interest payment extension period | May 01, 2023 | |||
Long-Term Debt, Description | extended the Maturity Date from October 1, 2023 to October 1, 2024; (iii) extended the availability of the Fourth Loan Tranche commitment of $20 million from May 1, 2023 to May 1, 2024 | |||
Commitment charge | $ 25,000 | |||
Transaction costs | 273,186 | |||
Credit facility fee | $ 375,000 | |||
Credit facility, interest rate | 13.70% | |||
Credit facility prepayment fee percentage | 0.75% | 0.75% | ||
Credit facility prepayment fee percentage, thereafter | 0% | |||
Long-Term Debt, Percentage Bearing Variable Interest, Percentage Rate | 0% | |||
Loan funded prior to the date of amendment | $ 15,000,000 | |||
Supplemental End Of Term Charge | $ 292,500 | |||
Existing End Of Term Charge | 1,042,500 | |||
Hercules Credit Facility [Member] | Maximum [Member] | ||||
Line Of Credit Facility [Line Items] | ||||
Loan agreement right to purchase aggregate amount of equity securities | $ 2,000,000 | |||
Hercules Credit Facility [Member] | Prime Rate [Member] | ||||
Line Of Credit Facility [Line Items] | ||||
Debt instrument variable annual interest rate | 3.10% | |||
Hercules Credit Facility [Member] | Term Loan Advance One [Member] | ||||
Line Of Credit Facility [Line Items] | ||||
Credit facility amount | $ 5,000,000 | |||
Hercules Credit Facility [Member] | Term Loan Advance Four [Member] | ||||
Line Of Credit Facility [Line Items] | ||||
Long-Term Debt | $ 20,000,000 | 15,000,000 | ||
Hercules Credit Facility [Member] | Term Loan Advance Five [Member] | ||||
Line Of Credit Facility [Line Items] | ||||
Long-Term Debt | 10,000,000 | $ 10,000,000 | ||
Debt instrument, increase amount | $ 20,000,000 |
Credit Facility - Schedule of L
Credit Facility - Schedule of Long-Term Debt (Detail) - USD ($) | Mar. 31, 2023 | Dec. 31, 2022 |
Line of Credit Facility [Abstract] | ||
Term loan payable | $ 15,000,000 | $ 15,000,000 |
End of term charge | 974,886 | 911,763 |
Unamortized debt issuance costs | (52,873) | (76,910) |
Less: current portion | (954,325) | (911,763) |
Total long-term debt | $ 14,967,688 | $ 14,923,090 |
Credit Facility - Schedule of P
Credit Facility - Schedule of Principal Payments Incuding End of Term Charges (Detail) | Dec. 31, 2022 USD ($) |
Line of Credit Facility [Abstract] | |
2023 | $ 1,042,500 |
2024 | 15,292,500 |
Total | $ 16,335,000 |
Stockholders' Equity - Addition
Stockholders' Equity - Additional Information (Detail) - USD ($) $ in Millions | 1 Months Ended | 3 Months Ended |
Mar. 31, 2021 | Mar. 31, 2022 | |
Common Stock [Member] | ||
Class Of Stock [Line Items] | ||
Issuance of common stock, employee stock purchase plan, Shares | 6,860 | |
Jefferies Sales Agreement [Member] | ||
Class Of Stock [Line Items] | ||
Issuance of common stock, employee stock purchase plan, Shares | 0 | |
Jefferies Sales Agreement [Member] | Maximum [Member] | ||
Class Of Stock [Line Items] | ||
Proceeds from issuance of common stock, net of commissions and other offering costs | $ 100 |
Income Taxes - Additional Infor
Income Taxes - Additional Information (Detail) | 3 Months Ended |
Mar. 31, 2023 USD ($) | |
Income Tax [Line Items] | |
Deferred tax assets valuation allowance | 100% |
Maximum [Member] | |
Income Tax [Line Items] | |
Statutory tax rate | 50% |
State and Federal [Member] | |
Income Tax [Line Items] | |
Income tax benefit | $ 0 |
Stock-Based Compensation - Addi
Stock-Based Compensation - Additional Information (Detail) $ / shares in Units, $ in Millions | 3 Months Ended | 12 Months Ended | |||
Mar. 31, 2023 USD ($) NumberOfPlan $ / shares shares | Mar. 31, 2022 $ / shares | Dec. 31, 2022 | Dec. 31, 2020 | Dec. 31, 2019 | |
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||||
Granted period | 4 years | 4 years | 4 years | ||
Share based compensation expense | $ 2.6 | ||||
Options to Purchase Common Stock [Member] | |||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||||
Unamortized stock-based compensation | $ 10 | ||||
Weighted average recognition period | 2 years 11 months 4 days | ||||
Restricted Stock Units (RSUs) [Member] | |||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||||
Share-Based Compensation Arrangement by Share-Based Payment Award, Options, Vested in Period, Fair Value | $ 1.2 | ||||
Unamortized stock-based compensation | $ 5.4 | ||||
Granted | shares | 238,750 | ||||
Weighted-average grant-date fair value per share | $ / shares | $ 6.76 | ||||
Weighted average remaining recognition period | 3 years 2 months 1 day | ||||
Aggregate intrinsic value of options outstanding | $ 12 | ||||
CSBU [Member] | |||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||||
Share based compensation expense | $ 2.5 | ||||
Equity Incentive Plan [Member] | |||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||||
Number of equity incentive plans | NumberOfPlan | 2 | ||||
Equity incentive plans, contractual term | ten years | ||||
Common stock available for issuance | shares | 6,872,672 | ||||
2016 Employee Stock Purchase Plan [Member] | |||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||||
Common stock available for issuance | shares | 2,355,322 | ||||
Weighted-average grant-date fair value per share | $ / shares | $ 2.70 | $ 1.65 |
Stock-Based Compensation - Sche
Stock-Based Compensation - Schedule of Stock-Based Compensation Expense (Detail) - USD ($) | 3 Months Ended | |
Mar. 31, 2023 | Mar. 31, 2022 | |
Share-based Compensation Arrangement by Share-based Payment Award, Compensation Cost [Line Items] | ||
Allocated Share Based Compensation Expense | $ 4,190,356 | $ 1,936,578 |
Research and Development Expenses [Member] | ||
Share-based Compensation Arrangement by Share-based Payment Award, Compensation Cost [Line Items] | ||
Allocated Share Based Compensation Expense | 2,191,368 | 845,667 |
General and Administrative Expenses [Member] | ||
Share-based Compensation Arrangement by Share-based Payment Award, Compensation Cost [Line Items] | ||
Allocated Share Based Compensation Expense | $ 1,998,988 | $ 1,090,911 |
Stock-Based Compensation - Summ
Stock-Based Compensation - Summary of Stock Option Activity (Detail) - USD ($) | 3 Months Ended | 12 Months Ended |
Mar. 31, 2023 | Dec. 31, 2022 | |
Share-Based Payment Arrangement [Abstract] | ||
Number of Shares Outstanding, Beginning Balance | 5,403,982 | |
Number of Shares, Granted | 1,028,064 | |
Number of Shares Outstanding, Ending Balance | 6,432,046 | 5,403,982 |
Number of Shares Exercisable, Ending Balance | 3,771,769 | |
Weighted Average Exercise Price, Beginning Balance | $ 5.90 | |
Weighted Average Exercise Price, Granted | 6.76 | |
Weighted Average Exercise Price, Ending Balance | 6.04 | $ 5.90 |
Weighted Average Exercise Price Exercisable, Ending Balance | $ 6.12 | |
Weighted Average Contractual Term, Outstanding | 6 years 10 months 17 days | 6 years 6 months 21 days |
Weighted Average Contractual Term, Exercisable | 5 years 3 months 18 days | |
Aggregate Intrinsic Value, Outstanding | $ 26,374,880 | $ 10,506,953 |
Aggregate Intrinsic Value, Exercisable | $ 15,217,207 |
Stock-Based Compensation - Su_2
Stock-Based Compensation - Summary of Stock Option Activity (Parenthetical) (Detail) | Mar. 31, 2023 $ / shares |
Share-Based Payment Arrangement [Abstract] | |
Closing market value of common stock | $ 9.93 |
Stock-Based Compensation - Su_3
Stock-Based Compensation - Summary of Activity Relating to Restricted Stock Units (Detail) - Restricted Stock Units (RSUs) [Member] | 3 Months Ended |
Mar. 31, 2023 $ / shares shares | |
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |
Outstanding at December 31, 2022 | shares | 1,184,603 |
Granted | shares | 238,750 |
Vested | shares | 215,253 |
Outstanding at March 31, 2023 | shares | 1,208,100 |
Weighted Average Grant Date Fair Value, Beginning Balance | $ / shares | $ 4.95 |
Weighted-Average Grant Date Fair Value, Granted | $ / shares | 6.76 |
Weighted-Average Grant Date Fair Value, Vested | $ / shares | 5.72 |
Weighted Average Grant Date Fair Value, Ending Balance | $ / shares | $ 5.17 |
Stock-Based Compensation - Su_4
Stock-Based Compensation - Summary of Employee Stock Purchase Plan Activity (Detail) - USD ($) | 3 Months Ended | |
Mar. 31, 2023 | Mar. 31, 2022 | |
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||
Allocated Share Based Compensation Expense | $ 4,190,356 | $ 1,936,578 |
2016 Employee Stock Purchase Plan [Member] | ||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||
Weighted-average grant-date fair value per share | $ 2.70 | $ 1.65 |
Allocated Share Based Compensation Expense | $ 17,040 | $ 22,468 |
Leases - Additional Information
Leases - Additional Information (Detail) | 3 Months Ended |
Mar. 31, 2023 USD ($) | |
Leases [Abstract] | |
Operating lease liability | $ 190,202 |
Operating leases, weighted average remaining lease term (years) | 9 months |
Operating leases, weighted average discount rate | 9.10% |
Operating lease, expense | $ 65,500 |
Leases - Schedule of Maturities
Leases - Schedule of Maturities and Balance Sheet Presentation of Lease Liabilities (Detail) - USD ($) | Mar. 31, 2023 | Dec. 31, 2022 |
Leases [Abstract] | ||
2023 remaining total lease payments | $ 197,540 | |
Less: effect of discounting | (7,338) | |
Present value of lease liabilities | 190,202 | |
Current operating lease liabilities | 190,202 | $ 249,265 |
Present value of lease liabilities | $ 190,202 |
Leases - Schedule of Future Min
Leases - Schedule of Future Minimum Payments Under Non-Cancelable Operating Leases (Detail) | Mar. 31, 2023 USD ($) |
Leases [Abstract] | |
2023 remaining total lease payments | $ 197,540 |
Operating lease obligations, 2023 | 197,540 |
Operating lease obligations, 2024 | 0 |
Operating lease obligations, 2025 | 0 |
2026 | $ 0 |
Commitments and Contingencies (
Commitments and Contingencies (Additional Information) (Details) | 3 Months Ended |
Mar. 31, 2023 USD ($) | |
Commitments And Contingencies [Line Items] | |
Outstanding material claims | $ 0 |
Reserve for indemnification | 0 |
M E E I Agreement [Member] | |
Commitments And Contingencies [Line Items] | |
Additional equity consideration issuable | 0 |
Second And Third Anniversary [Member] | M E E I Agreement [Member] | |
Commitments And Contingencies [Line Items] | |
Non-creditable non-refundable license maintenance fees | 15,000 |
Fourth And Fifth Anniversary [Member] | M E E I Agreement [Member] | |
Commitments And Contingencies [Line Items] | |
Non-creditable non-refundable license maintenance fees | 25,000 |
Sixth And Subsequent Anniversary [Member] | M E E I Agreement [Member] | |
Commitments And Contingencies [Line Items] | |
Non-creditable non-refundable license maintenance fees | $ 35,000 |