Document and Entity Information
Document and Entity Information - shares | 3 Months Ended | |
Mar. 31, 2023 | May 10, 2023 | |
Document and Entity Information | ||
Document Type | 10-Q | |
Document Quarterly Report | true | |
Document Period End Date | Mar. 31, 2023 | |
Document Transition Report | false | |
Entity File Number | 001-38365 | |
Entity Registrant Name | EYENOVIA, INC. | |
Entity Incorporation, State or Country Code | DE | |
Entity Tax Identification Number | 47-1178401 | |
Entity Address, Postal Zip Code | 10017 | |
Entity Address, Address Line One | 295 Madison Avenue, Suite 2400 | |
Entity Address, City or Town | NEW YORK | |
Entity Address, State or Province | NY | |
City Area Code | 833 | |
Local Phone Number | 393-6684 | |
Title of 12(b) Security | Common Stock, par value $0.0001 per share | |
Trading Symbol | EYEN | |
Security Exchange Name | NASDAQ | |
Entity Current Reporting Status | Yes | |
Entity Interactive Data Current | Yes | |
Entity Filer Category | Non-accelerated Filer | |
Entity Small Business | true | |
Entity Emerging Growth Company | true | |
Entity Ex Transition Period | false | |
Entity Shell Company | false | |
Entity Common Stock, Shares Outstanding | 38,002,965 | |
Entity Central Index Key | 0001682639 | |
Current Fiscal Year End Date | --12-31 | |
Document Fiscal Year Focus | 2023 | |
Document Fiscal Period Focus | Q1 | |
Amendment Flag | false |
Condensed Balance Sheets
Condensed Balance Sheets - USD ($) | Mar. 31, 2023 | Dec. 31, 2022 |
Current Assets: | ||
Cash and cash equivalents | $ 18,466,322 | $ 22,863,520 |
Deferred clinical supply costs | 3,352,645 | 2,284,931 |
License fee and expense reimbursements receivable | 973,677 | 1,183,786 |
Security deposits, current | 119,550 | 119,550 |
Prepaid expenses and other current assets | 2,011,884 | 1,190,719 |
Total Current Assets | 24,924,078 | 27,642,506 |
Property and equipment, net | 2,152,861 | 1,295,115 |
Security deposits, non-current | 80,874 | 80,874 |
Operating lease right-of-use asset | 1,508,158 | 1,291,592 |
Equipment deposits | 643,513 | 726,326 |
Total Assets | 29,309,484 | 31,036,413 |
Current Liabilities: | ||
Accounts payable | 1,402,076 | 1,428,283 |
Accrued compensation | 637,189 | 1,747,191 |
Accrued expenses and other current liabilities | 460,143 | 503,076 |
Operating lease liabilities - current portion | 472,901 | 484,882 |
Notes payable - current portion, net of debt discount of $123,480 and $33,885 as of March 31, 2023 and December 31, 2022, respectively | 1,218,963 | 174,448 |
Convertible notes payable - current portion, net of debt discount of $123,480 and $33,885 as of March 31, 2023 and December 31, 2022, respectively | 709,853 | 174,448 |
Total Current Liabilities | 4,901,125 | 4,512,328 |
Lease liabilities - non-current portion | 1,133,948 | 907,644 |
Notes payable - non-current portion, net of debt discount of $648,889 and $813,229 as of March 31, 2023 and December 31, 2022, respectively | 3,730,278 | 4,190,938 |
Convertible notes payable - non-current portion, net of debt discount of $648,889 and $813,229 as of March 31, 2023 and December 31, 2022, respectively | 3,730,278 | 4,190,938 |
Total Liabilities | 13,495,629 | 13,801,848 |
Commitments and contingencies | ||
Stockholders' Equity: | ||
Preferred stock, $0.0001 par value, 6,000,000 shares authorized; 0 shares issued and outstanding as of March 31, 2023 and December 31, 2022 | ||
Common stock, $0.0001 par value, 90,000,000 shares authorized; 37,991,746 and 36,668,980 shares issued and outstanding as of March 31, 2023 and December 31, 2022, respectively | 3,799 | 3,667 |
Additional paid-in capital | 139,779,885 | 135,461,361 |
Accumulated deficit | (123,969,829) | (118,230,463) |
Total Stockholders' Equity | 15,813,855 | 17,234,565 |
Total Liabilities and Stockholders' Equity | $ 29,309,484 | $ 31,036,413 |
Condensed Balance Sheets (Paren
Condensed Balance Sheets (Parenthetical) - USD ($) | Mar. 31, 2023 | Dec. 31, 2022 |
Condensed Balance Sheets | ||
Notes payable - current portion, net of debt discount | $ 123,480 | $ 33,885 |
Convertible notes payable - current portion, net of debt discount | 123,480 | 33,885 |
Notes payable - non-current portion, net of debt discount | 648,889 | 813,229 |
Convertible notes payable - non-current portion, net of debt discount | $ 648,889 | $ 813,229 |
Preferred stock, par value | $ 0.0001 | $ 0.0001 |
Preferred stock, shares authorized | 6,000,000 | 6,000,000 |
Preferred stock, shares issued | 0 | 0 |
Preferred stock, shares outstanding | 0 | 0 |
Common Stock, par value | $ 0.0001 | $ 0.0001 |
Common stock, shares authorized | 90,000,000 | 90,000,000 |
Common stock, shares issued | 37,991,746 | 36,668,980 |
Common stock, shares outstanding | 37,991,746 | 36,668,980 |
Condensed Statements of Operati
Condensed Statements of Operations - USD ($) | 3 Months Ended | |
Mar. 31, 2023 | Mar. 31, 2022 | |
Operating Expenses: | ||
Research and development | $ 2,521,950 | $ 3,712,584 |
General and administrative | 2,936,886 | 3,474,965 |
Total Operating Expenses | 5,458,836 | 7,187,549 |
Loss From Operations | (5,458,836) | (7,187,549) |
Other Income (Expense): | ||
Other income (expense), net | 70,993 | (7,073) |
Interest expense | (454,003) | (145,237) |
Interest income | 102,480 | 194 |
Net Loss | $ (5,739,366) | $ (7,339,665) |
Net Loss Per Share | ||
Net Loss Per Share - Basic | $ (0.15) | $ (0.24) |
Net Loss Per Share - Diluted | $ (0.15) | $ (0.24) |
Weighted Average Number of Common Shares Outstanding | ||
Weighted Average Number of Common Shares Outstanding - Basic | 37,410,587 | 30,008,194 |
Weighted Average Number of Common Shares Outstanding - Diluted | 37,410,587 | 30,008,194 |
Condensed Statements of Changes
Condensed Statements of Changes in Stockholders' Equity - USD ($) | Common Stock | Additional Paid-In Capital | Accumulated Deficit | Total | |
Balance at the beginning at Dec. 31, 2021 | $ 2,844 | $ 110,683,077 | $ (90,219,306) | $ 20,466,615 | |
Balance at the beginning (in shares) at Dec. 31, 2021 | 28,426,616 | ||||
Stock-based compensation | 908,987 | 908,987 | |||
Issuance of common stock related to vested restricted stock units | $ 2 | (2) | |||
Issuance of common stock related to vested restricted stock units (in shares) | 19,359 | ||||
Issuance of common stock and warrants in registered direct offering | [1] | $ 300 | 14,897,608 | 14,897,908 | |
Issuance of common stock and warrants in registered direct offering (in shares) | [1] | 3,000,000 | |||
Issuance of common stock in At the Market offering | [2] | $ 25 | 860,340 | 860,365 | |
Issuance of common stock in At the Market offering (in shares) | [2] | 252,449 | |||
Net loss | (7,339,665) | (7,339,665) | |||
Balance at the end at Mar. 31, 2022 | $ 3,171 | 127,350,010 | (97,558,971) | 29,794,210 | |
Balance at the end (in shares) at Mar. 31, 2022 | 31,698,424 | ||||
Balance at the beginning at Dec. 31, 2022 | $ 3,667 | 135,461,361 | (118,230,463) | 17,234,565 | |
Balance at the beginning (in shares) at Dec. 31, 2022 | 36,668,980 | ||||
Cashless exercise of stock options | $ 2 | (2) | |||
Cashless exercise of stock options (in shares) | 19,530 | ||||
Stock-based compensation | 819,064 | 819,064 | |||
Issuance of common stock related to vested restricted stock units (in shares) | 3,289 | ||||
Issuance of common stock in At the Market offering | [3] | $ 130 | 3,499,462 | 3,499,592 | |
Issuance of common stock in At the Market offering (in shares) | [3] | 1,299,947 | |||
Net loss | (5,739,366) | (5,739,366) | |||
Balance at the end at Mar. 31, 2023 | $ 3,799 | $ 139,779,885 | $ (123,969,829) | $ 15,813,855 | |
Balance at the end (in shares) at Mar. 31, 2023 | 37,991,746 | ||||
[1] Includes gross proceeds of $14,981,299 less total issuance costs of $83,391 Includes gross proceeds of $886,974 , less total issuance costs of $26,609 Includes gross proceeds of $3,607,827 less total issuance costs of $108,235 |
Condensed Statements of Chang_2
Condensed Statements of Changes in Stockholders' Equity (Parenthetical) - USD ($) | 3 Months Ended | |
Mar. 31, 2023 | Mar. 31, 2022 | |
Common stock one | ||
Proceeds of stock issued during period gross | $ 3,607,827 | $ 14,981,299 |
Adjustments to additional paid in capital upon stock issuance costs | $ 108,235 | 83,391 |
Common stock two | ||
Proceeds of stock issued during period gross | 886,974 | |
Adjustments to additional paid in capital upon stock issuance costs | $ 26,609 |
Condensed Statements of Cash Fl
Condensed Statements of Cash Flows - USD ($) | 3 Months Ended | ||
Mar. 31, 2023 | Mar. 31, 2022 | ||
Cash Flows From Operating Activities | |||
Net loss | $ (5,739,366) | $ (7,339,665) | |
Adjustments to reconcile net loss to net cash used in operating activities: | |||
Stock-based compensation | 819,064 | 908,987 | |
Depreciation of property and equipment | 63,119 | 75,432 | |
Amortization of debt discount | 149,490 | 26,215 | |
Amortization of operating lease right-of-use asset | 133,907 | 89,718 | |
Changes in operating assets and liabilities: | |||
Prepaid expenses and other current assets | (212,025) | (907,774) | |
License fee and expense reimbursements receivables | 210,109 | 440,756 | |
Deferred clinical supply costs | (1,067,714) | ||
Accounts payable | (26,207) | (79,340) | |
Accrued compensation | (1,110,002) | (868,224) | |
Accrued expenses and other current liabilities | (42,933) | (441,012) | |
Lease liabilities | (136,150) | (89,492) | |
Net Cash Used In Operating Activities | (6,958,708) | (8,184,399) | |
Cash Flows From Investing Activities | |||
Purchases of property and equipment | (920,865) | (174,567) | |
Vendor deposits for property and equipment | 82,813 | (33,095) | |
Net Cash Used In Investing Activities | (838,052) | (207,662) | |
Cash Flows From Financing Activities | |||
Proceeds from sale of common stock and warrants in direct offering | [1] | 14,981,299 | |
Proceeds from sale of common stock in At the Market offering | [2] | 3,607,827 | 860,365 |
Payment of issuance costs for At the Market offering | (108,235) | ||
Repayments of notes payable | (100,030) | (111,793) | |
Payment of offering issuance costs | (83,391) | ||
Net Cash Provided By Financing Activities | 3,399,562 | 15,646,480 | |
Net (Decrease) Increase in Cash and Cash Equivalents | (4,397,198) | 7,254,419 | |
Cash, cash equivalents and restricted cash - Beginning of Period | 22,863,520 | 27,336,850 | |
Cash, cash equivalents and restricted cash - End of Period | 18,466,322 | 34,591,269 | |
Cash, cash equivalents and restricted cash consisted of the following: | |||
Cash and cash equivalents | 18,466,322 | 26,716,269 | |
Restricted cash | 7,875,000 | ||
Total | 18,466,322 | 34,591,269 | |
Supplemental Disclosure of Cash Flow Information: | |||
Interest | 304,512 | 95,585 | |
Supplemental Disclosure of Non-Cash Investing and Financing Activities | |||
Purchase of insurance premium financed by note payable | 609,140 | 675,331 | |
Recognition of right-of-use asset for lease liability upon adoption of ASU 2016-02 | 618,906 | ||
Right-of-use assets obtained in exchange for lease liabilities | 350,473 | 79,181 | |
Cashless exercise of stock options | $ 2 | ||
Issuance of common stock related to vested restricted stock units | $ 2 | ||
[1]Includes gross proceeds of $14,981,299, of which $5,741,299 is pre-funded warrants.[2]Includes gross proceeds of $886,974, less total issuance costs of $26,609 |
Condensed Statements of Cash _2
Condensed Statements of Cash Flows (Parenthetical) - USD ($) | 3 Months Ended | |
Mar. 31, 2023 | Mar. 31, 2022 | |
Common stock one | ||
Proceeds of stock issued during period gross | $ 14,981,299 | |
Common stock one | Pre-funded warrants | ||
Proceeds of stock issued during period gross | 5,741,299 | |
Common stock two | ||
Proceeds of stock issued during period gross | $ 886,974 | 886,974 |
Payments of debt issuance costs | $ 26,609 | $ 26,609 |
Business Organization, Nature o
Business Organization, Nature of Operations and Basis of Presentation | 3 Months Ended |
Mar. 31, 2023 | |
Business Organization, Nature of Operations and Basis of Presentation | |
Business Organization and Nature of Operations | Note 1 – Business Organization, Nature of Operations and Basis of Presentation Eyenovia, Inc. (“Eyenovia” or the “Company”) is an ophthalmic technology company developing the Optejet® delivery system for use both in combination with its own drug-device therapeutic programs in mydriasis (pupil dilation), presbyopia and pediatric progressive myopia as well as out-licensing for additional indications. The Company’s investigational products are classified by the Food and Drug Administration (“FDA”) as drug-device combination products with drug primary mode of action, meaning that the Center for Drug Evaluation and Research, or CDER, is designated as the lead center with primary jurisdictional oversight. Accordingly, the product candidates are submitted to the FDA and CDER for premarket review and approval under new drug applications, or NDAs. The accompanying unaudited condensed financial statements have been prepared in accordance with accounting principles generally accepted in the United States of America (“U.S. GAAP”) for interim financial information and with the instructions to Form 10-Q and Article 8 of Regulation S-X. Accordingly, they do not include all of the information and disclosures required by U.S. GAAP for complete financial statements. In the opinion of management, such statements include all adjustments (consisting only of normal recurring items) which are considered necessary for a fair presentation of the condensed financial statements of the Company as of March 31, 2023 and for the three months ended March 31, 2023 and 2022. The results of operations for the three months ended March 31, 2023 are not necessarily indicative of the operating results for the full year ending December 31, 2023 or any other period. These unaudited condensed financial statements should be read in conjunction with the audited financial statements and related disclosures of the Company as of December 31, 2022 and for the year then ended, which were included in the Company’s Annual Report on Form 10-K filed with the Securities and Exchange Commission (“SEC”) on March 31, 2023, as amended by Amendment No. 1, filed with the SEC on May 1, 2023. |
Going Concern and Summary of Si
Going Concern and Summary of Significant Accounting Policies | 3 Months Ended |
Mar. 31, 2023 | |
Going Concern and Summary of Significant Accounting Policies | |
Going Concern and Summary of Significant Accounting Policies | Note 2 – Going Concern and Summary of Significant Accounting Policies Since the date of the Company’s Annual Report on Form 10-K for the year ended December 31, 2022, there have been no material changes to the Company’s significant accounting policies, except as disclosed below. Going Concern As of March 31, 2023, the Company had unrestricted cash and cash equivalents in the aggregate amount of approximately $18.5 million. For the three months ended March 31, 2023 and 2022, the Company incurred net losses of approximately $5.7 million and $7.3 million, respectively, and used cash in operations of approximately $7.0 million and $8.2 million, respectively. The Company does not have recurring revenue, has not yet achieved profitability and may not become profitable. The Company expects to continue to incur cash outflows from operations. The Company expects that its research and development and general and administrative expenses will continue to increase and, as a result, it will eventually need to generate significant product revenues to achieve profitability. These circumstances raise substantial doubt about the Company’s ability to continue as a going concern for at least one year from the date that these financial statements are issued. Implementation of the Company’s plans and its ability to continue as a going concern will depend upon the Company’s ability to raise further capital, through the sale of additional equity or debt securities or otherwise, to support its future operations. The Company’s operating needs include the planned costs to operate its business, including amounts required to fund working capital and capital expenditures. The Company’s future capital requirements and the adequacy of its available funds will depend on many factors, including the Company’s ability to successfully commercialize its products and services, competing technological and market developments, and the need to enter into collaborations with other companies or acquire other companies or technologies to enhance or complement the Company’s product and service offerings. If the Company is unable to secure additional capital, it may be required to curtail its research and development initiatives and/or take additional measures to reduce costs in order to conserve its cash. Reclassifications Certain prior period balances have been reclassified in order to conform to current period presentation. These reclassifications have no effect on previously reported results of operations or loss per share. Cash, Cash Equivalents and Restricted Cash The Company considers all highly liquid investments with an original maturity of three months or less to be cash equivalents in the financial statements.As of March 31, 2023, the Company had Treasury bills with original maturity dates of three months or less in the amount of $15,910,834. The Company has cash deposits in a financial institution that, at times, may be in excess of Federal Deposit Insurance Corporation (“FDIC”) insurance limits. The Company has not experienced losses in such accounts and periodically evaluates the creditworthiness of its financial institutions. As of March 31, 2023 and December 31, 2022, the Company had cash balances in excess of FDIC insurance limits of $2,055,488 and $22,613,520, respectively. On March 10, 2023, Silicon Valley Bank, or SVB, was closed by the California Department of Financial Protection and Innovation, and the Federal Deposit Insurance Corporation, or FDIC, was appointed as receiver. The Company has deposit accounts at SVB. The standard deposit insurance amount is up to $250,000 per depositor, per insured bank, for each account ownership category. As of the date of filing, the Company had approximately $305,000 in a deposit account at SVB. Net Loss Per Common Share Basic net loss per common share is computed by dividing net loss by the weighted average number of common shares outstanding during the period plus fully vested shares that are subject to issuance for little or no monetary consideration. Diluted earnings per share reflects the potential dilution that could occur if securities or other instruments to issue common stock were exercised or converted into common stock. The following table presents the computation of basic and diluted net loss per common share: For the Three Months Ended March 31, 2023 2022 Numerator: Net loss $ (5,739,366) $ (7,339,665) Net loss attributable to common stockholders $ (5,739,366) $ (7,339,665) Denominator (weighted average quantities): Common shares issued 37,380,976 28,032,758 Add: Prefunded warrants — 1,870,130 Add: Undelivered vested restricted shares 29,611 105,306 Denominator for basic and diluted net loss per share 37,410,587 30,008,194 Basic and diluted net loss per common share $ (0.15) $ (0.24) The following securities are excluded from the calculation of weighted average diluted common shares because their inclusion would have been anti-dilutive: March 31, 2023 2022 Options 5,460,099 4,774,473 Warrants 6,087,845 7,957,975 Restricted stock units 150,578 115,329 Total potentially dilutive shares 11,698,522 12,847,777 Clinical Supply Arrangements Bausch + Lomb, Inc. (“B+L”) and Arctic Vision (Hong Kong) Limited (“Arctic Vision”) have contracted with the Company to manufacture and supply them with the appropriate drug-device combination products to conduct their clinical trials on a cost plus 10% mark-up basis. The Company’s licensing agreements with B+L and Arctic Vision represent collaborative arrangements and they are not a customer with respect to the clinical supply arrangements. The Company’s policy is to (a) defer the materials and manufacturing costs in order to properly match them up against the income from the clinical supply arrangements; and (b) to report the net income from the clinical supply arrangements as other income. Recently Adopted Accounting Standards In June 2016, the FASB issued ASU No. 2016-13, “Financial Instruments - Credit Losses (Topic 326)” and also issued subsequent amendments to the initial guidance under ASU 2018-19, ASU 2019-04 and ASU 2019-05 (collectively, “Topic 326”). Topic 326 requires the measurement and recognition of expected credit losses for financial assets held at amortized cost. This replaces the existing incurred loss model with an expected loss model and requires the use of forward-looking information to calculate credit loss estimates. The Company adopted ASU 2016-13 on January 1, 2023. The adoption of ASU 2016-13 did not have a material impact on the Company’s financial position, results of operations or cash flows. In August 2020, the FASB issued ASU 2020-06, “Debt—Debt with Conversion and Other Options (Subtopic 470-20)” and “Derivatives and Hedging— Contracts in Entity’s Own Equity (Subtopic 815-40): Accounting for Convertible Instruments and Contracts in an Entity’s Own Equity”, to clarify the accounting for certain financial instruments with characteristics of liabilities and equity. The amendments in this update reduce the number of accounting models for convertible debt instruments and convertible preferred stock by removing the cash conversion model and the beneficial conversion feature model. Limiting the accounting models will result in fewer embedded conversion features being separately recognized from the host contract. Convertible instruments that continue to be subject to separation models are (1) those with embedded conversion features that are not clearly and closely related to the host contract, that meet the definition of a derivative, and that do not qualify for a scope exception from derivative accounting and (2) convertible debt instruments issued with substantial premiums for which the premiums are recorded as paid-in-capital. In addition, ASU 2020-06 improves disclosure requirements for convertible instruments and earnings-per-share guidance. ASU 2020-06 also revises the derivative scope exception guidance to reduce form-over-substance-based accounting conclusions driven by remote contingent events. The amendments in this update are effective for the Company in fiscal years beginning after December 15, 2023, and interim periods within those fiscal years. Early adoption is permitted. The Company early adopted ASU 2020-06 effective January 1, 2023 which eliminates the need to assess whether a beneficial conversion feature needs to be recognized upon the issuance of new convertible instruments. The adoption of ASU 2020-06 did not have a material impact on the Company’s financial position, results of operations or cash flows. |
Prepaid Expenses and Other Curr
Prepaid Expenses and Other Current Assets | 3 Months Ended |
Mar. 31, 2023 | |
Prepaid Expenses and Other Current Assets | |
Prepaid Expenses and Other Current Assets | Note 3 – Prepaid Expenses and Other Current Assets As of March 31, 2023 and December 31, 2022, prepaid expenses and other current assets consisted of the following: March 31, December 31, 2023 2022 Prepaid insurance expenses $ 803,486 $ 201,082 Payroll tax receivable 645,566 660,891 Prepaid general and administrative expenses 176,935 87,982 Prepaid conference expenses 132,026 97,743 Prepaid board of directors fees 106,250 — Prepaid patent expenses 61,569 38,796 Prepaid rent and security deposit 18,750 74,959 Prepaid research and development expenses 13,006 2,521 Other 54,296 26,745 Total prepaid expenses and other current assets $ 2,011,884 $ 1,190,719 |
Accrued Compensation
Accrued Compensation | 3 Months Ended |
Mar. 31, 2023 | |
Accrued Compensation | |
Accrued Compensation | Note 4 – Accrued Compensation As of March 31, 2023 and December 31, 2022, accrued compensation consisted of the following: March 31, December 31, 2023 2022 Accrued bonus expenses $ 330,500 $ 1,447,643 Accrued payroll expenses 306,689 299,548 Total accrued compensation $ 637,189 $ 1,747,191 |
Accrued Expenses and Other Curr
Accrued Expenses and Other Current Liabilities | 3 Months Ended |
Mar. 31, 2023 | |
Accrued Expenses and Other Current Liabilities | |
Accrued Expenses and Other Current Liabilities | Note 5 – Accrued Expenses and Other Current Liabilities As of March 31, 2023 and December 31, 2022, accrued expenses and other current liabilities consisted of the following: March 31, December 31, 2023 2022 Accrued consulting and professional services $ 325,886 $ 320,000 Accrued research and development expenses 59,090 35,524 Other 24,537 4,385 Credit card payable 22,286 50,639 Accrued travel and entertainment expenses 15,244 — Accrued franchise tax 13,100 — Accrued leasehold improvements — 92,528 Total accrued expenses and other current liabilities $ 460,143 $ 503,076 |
Notes Payable
Notes Payable | 3 Months Ended |
Mar. 31, 2023 | |
Notes Payable | |
Notes Payable | Note 6 – Notes Payable As of March 31, 2023 and December 31, 2022, notes payable consisted of the following: March 31, 2023 December 31, 2022 Notes Payable Debt Discount Net Notes Payable Debt Discount Net D&O insurance policy loan $ 509,110 $ — $ 509,110 $ — $ — $ — Avenue - Note payable 5,212,500 (772,369) 4,440,131 5,212,500 (847,114) 4,365,386 Avenue - Convertible note payable 5,212,500 (772,369) 4,440,131 5,212,500 (847,114) 4,365,386 Total 10,934,110 (1,544,738) 9,389,372 10,425,000 (1,694,228) 8,730,772 Current portion D&O insurance policy loan 509,110 — 509,110 — — — Avenue - Note payable 833,333 (123,480) 709,853 208,333 (33,885) 174,448 Avenue - Convertible note payable 833,333 (123,480) 709,853 208,333 (33,885) 174,448 Notes Payable, Current 2,175,776 (246,960) 1,928,816 416,666 (67,770) 348,896 Notes Payable, Non-Current $ 8,758,334 $ (1,297,778) $ 7,460,556 $ 10,008,334 $ (1,626,458) $ 8,381,876 On February 24, 2023, the Company issued a note payable in the amount of $609,140 for the purchase of a directors and officers’ liability insurance policy (the “D&O Loan”). The note accrues interest at a rate of 7.11% per year and matures on August 24, 2023. The D&O Loan is payable in six During the three months ended March 31, 2023, the Company recorded interest expense of $454,003, of which $450,394 is related to the Loan and Security Agreement with Avenue Capital Management II, L.P. (“Avenue”) and related entities, (including amortization of debt discount of $149,490) and $3,609 is related to the D&O Loan. During the three months ended March 31, 2022, the Company recorded interest expense of $145,237, of which $143,403 was related to a fully repaid loan and $1,834 was related to the D&O Loan. |
Commitments and Contingencies
Commitments and Contingencies | 3 Months Ended |
Mar. 31, 2023 | |
Commitments and Contingencies | |
Commitments and Contingencies | Note 7 – Commitments and Contingencies Operating Leases In February 2023, the Company exercised its options to renew its three leases in Redwood City, California, for a total of approximately 6,700 square feet. The leases were due to expire on August 31, 2023. The leases were extended from September 1, 2023 to August 31, 2025. A summary of the Company’s right-of-use assets and liabilities is as follows: For the Three Months Ended March 31, 2023 Cash paid for amounts included in the measurement of lease liabilities: Operating cash flows used in operating activities $ 136,150 Right-of-use assets obtained in exchange for lease obligations Operating leases $ 350,473 Weighted Average Remaining Lease Term (Years) Operating leases 3.50 years Weighted Average Discount Rate Operating leases 10.0 % Future minimum payments under all of the Company’s operating lease agreements are as follows: For the Year Ending December 31, Minimum Lease Payments 2023 $ 482,350 2024 480,984 2025 429,992 2026 308,839 2027 214,619 Total future minimum lease payments 1,916,784 Less: amount representing imputed interest (309,935) Present value of lease liabilities 1,606,849 Less: current portion (472,901) Lease liabilities, non current portion $ 1,133,948 Litigations, Claims and Assessments The Company may be involved in legal proceedings, claims and assessments arising in the ordinary course of business. The Company records legal costs associated with loss contingencies as incurred and accrues for all probable and estimable settlements. |
Stockholders' Equity
Stockholders' Equity | 3 Months Ended |
Mar. 31, 2023 | |
Stockholders' Equity | |
Stockholders' Equity | Note 8 – Stockholders’ Equity At-The-Market Offering During the three months ended March 31, 2023, the Company received approximately $3.5 million in net proceeds from the sale of 1,299,947 shares of its common stock pursuant to its Sales Agreement with SVB Securities LLC (“SVB Securities”) in an ”at-the-market” offering. Stock-Based Compensation Expense The Company records stock-based compensation expense related to stock options and restricted stock units (“RSUs”). For the three months ended March 31, 2023 and 2022, the Company recorded expense of $819,064 ($375,130 of which was included within research and development expenses and $443,934 was included within general and administrative expenses on the statements of operations) and $908,987 ($501,181 of which was included within research and development expenses and $407,806 was included within general and administrative expenses on the statements of operations), respectively. Restricted Stock Units A summary of RSU activity during the three months ended March 31, 2023 is presented below: Weighted Average Number of Grant Date Value RSUs Per Share RSUs non-vested January 1, 2023 172,800 $ 1.80 Granted — — Vested — — Forfeited (22,222) 1.80 RSUs non-vested March 31, 2023 150,578 $ 1.80 Vested RSUs undelivered March 31, 2023 29,611 $ 3.68 To date, RSUs have only been granted to directors in accordance with the Company’s Amended and Restated 2018 Omnibus Stock Incentive Plan. The Company’s policy is to defer settlement of such RSUs until the termination of such director’s service on the Company’s board of directors. On February 28, 2023, the Company delivered 3,289 shares of common stock in respect of RSUs upon the resignation of a director. As of March 31, 2023, there was $62,079 of unrecognized stock-based compensation expense related to RSUs that will be recognized over a weighted average period of 0.3 years. Stock Options In applying the Black-Scholes option pricing model to stock options granted, the Company used the following approximate assumptions: For the Three Months Ended March 31, 2023 2022 Expected term (years) 5.85 - 10.00 0.58 - 10.00 Risk free interest rate 3.60% - 4.18% 0.76% - 1.98% Expected volatility 82% - 83% 82% - 90% Expected dividends 0.00% 0.00% The Company has computed the fair value of stock options granted using the Black-Scholes option pricing model. Option forfeitures are accounted for at the time of occurrence. The expected term used for options issued is the estimated period of time that options granted are expected to be outstanding. The Company utilizes the “simplified” method to develop an estimate of the expected term of “plain vanilla” option grants. The Company uses a blended volatility calculation, the components of which are the Company’s historical volatility for the period from its initial public offering through the valuation date and the average peer-group data of six comparable entities to supplement the Company’s own historical data for the preceding years in computing the expected volatility. Accordingly, the Company is utilizing an expected volatility figure based on a review of the historical volatility of comparable entities over a period of time equivalent to the expected life of the instrument being valued. The risk-free interest rate was determined from the implied yields from U.S. Treasury zero-coupon bonds with a remaining term consistent with the expected term of the instrument being valued. The Company has not declared dividends, is currently in the development stage and has no plan to declare future dividends at this time. The weighted average estimated grant date fair value of the stock options granted for the three months ended March 31, 2023 and 2022 was approximately $1.61 and $2.28 per share, respectively. On January 25, 2023, the Company issued 19,530 shares of common stock pursuant to the cashless exercise of 73,334 stock options. A summary of the option activity during the three months ended March 31, 2023 is presented below: Average Remaining Aggregate Number of Exercise Life Intrinsic Options Price In Years Value Outstanding as of January 1, 2023 5,380,553 $ 3.55 Granted 441,235 2.22 Exercised (73,334) 1.56 Forfeited (288,355) 3.68 Outstanding as of March 31, 2023 5,460,099 $ 3.52 7.2 $ 4,358,468 Exercisable as of March 31, 2023 3,933,774 $ 3.78 6.3 $ 2,398,462 The following table presents information related to stock options as of March 31, 2023: Options Outstanding Options Exercisable Weighted Outstanding Average Exercisable Exercise Number of Remaining Life Number of Price Options In Years Options $1.00 - $1.99 1,487,183 3.6 754,302 $2.00 - $2.99 1,360,358 7.2 938,202 $3.00 - $3.99 1,056,008 6.9 944,246 $4.00 - $4.99 364,581 8.3 220,684 $5.00 - $5.99 84,137 6.1 83,972 $6.00 - $6.99 942,914 6.7 827,450 $7.00 + 164,918 5.0 164,918 5,460,099 6.3 3,933,774 As of March 31, 2023, there was $3,228,544 of unrecognized stock-based compensation expense related to stock options that will be recognized over a weighted average period of 1.6 years. |
Employee Benefit Plans
Employee Benefit Plans | 3 Months Ended |
Mar. 31, 2023 | |
Employee Benefit Plans | |
Employee Benefit Plans | Note 9 – Employee Benefit Plans 401(k) Plan In April 2019, the Company adopted the Eyenovia 401(k) Plan (the “Plan”), which went into effect in May 2019. All Company employees are able to participate in the Plan, subject to eligibility requirements as outlined in the Plan documents. Under the terms of the Plan, eligible employees are able to defer a percentage of their pay every pay period up to annual limitations set by Congress and the Internal Revenue Service under Section 401(k) of the Internal Revenue Code. For 2023 and 2022, the Company’s Board of Directors approved a matching contribution equal to 100% of elective deferrals up to 4% of eligible earnings with the matching contribution subject to certain vesting requirements as outlined in the Plan documents. During the three months ended March 31, 2023 and 2022, the Company recorded expense of $78,969 and $86,099 , respectively, associated with its matching contributions, respectively. |
Going Concern and Summary of _2
Going Concern and Summary of Significant Accounting Policies (Policies) | 3 Months Ended |
Mar. 31, 2023 | |
Going Concern and Summary of Significant Accounting Policies | |
Going Concern | Going Concern As of March 31, 2023, the Company had unrestricted cash and cash equivalents in the aggregate amount of approximately $18.5 million. For the three months ended March 31, 2023 and 2022, the Company incurred net losses of approximately $5.7 million and $7.3 million, respectively, and used cash in operations of approximately $7.0 million and $8.2 million, respectively. The Company does not have recurring revenue, has not yet achieved profitability and may not become profitable. The Company expects to continue to incur cash outflows from operations. The Company expects that its research and development and general and administrative expenses will continue to increase and, as a result, it will eventually need to generate significant product revenues to achieve profitability. These circumstances raise substantial doubt about the Company’s ability to continue as a going concern for at least one year from the date that these financial statements are issued. Implementation of the Company’s plans and its ability to continue as a going concern will depend upon the Company’s ability to raise further capital, through the sale of additional equity or debt securities or otherwise, to support its future operations. The Company’s operating needs include the planned costs to operate its business, including amounts required to fund working capital and capital expenditures. The Company’s future capital requirements and the adequacy of its available funds will depend on many factors, including the Company’s ability to successfully commercialize its products and services, competing technological and market developments, and the need to enter into collaborations with other companies or acquire other companies or technologies to enhance or complement the Company’s product and service offerings. If the Company is unable to secure additional capital, it may be required to curtail its research and development initiatives and/or take additional measures to reduce costs in order to conserve its cash. |
Reclassifications | Reclassifications Certain prior period balances have been reclassified in order to conform to current period presentation. These reclassifications have no effect on previously reported results of operations or loss per share. |
Cash, Cash Equivalents and Restricted Cash | Cash, Cash Equivalents and Restricted Cash The Company considers all highly liquid investments with an original maturity of three months or less to be cash equivalents in the financial statements.As of March 31, 2023, the Company had Treasury bills with original maturity dates of three months or less in the amount of $15,910,834. The Company has cash deposits in a financial institution that, at times, may be in excess of Federal Deposit Insurance Corporation (“FDIC”) insurance limits. The Company has not experienced losses in such accounts and periodically evaluates the creditworthiness of its financial institutions. As of March 31, 2023 and December 31, 2022, the Company had cash balances in excess of FDIC insurance limits of $2,055,488 and $22,613,520, respectively. On March 10, 2023, Silicon Valley Bank, or SVB, was closed by the California Department of Financial Protection and Innovation, and the Federal Deposit Insurance Corporation, or FDIC, was appointed as receiver. The Company has deposit accounts at SVB. The standard deposit insurance amount is up to $250,000 per depositor, per insured bank, for each account ownership category. As of the date of filing, the Company had approximately $305,000 in a deposit account at SVB. |
Net Loss Per Share of Common Stock | Net Loss Per Common Share Basic net loss per common share is computed by dividing net loss by the weighted average number of common shares outstanding during the period plus fully vested shares that are subject to issuance for little or no monetary consideration. Diluted earnings per share reflects the potential dilution that could occur if securities or other instruments to issue common stock were exercised or converted into common stock. The following table presents the computation of basic and diluted net loss per common share: For the Three Months Ended March 31, 2023 2022 Numerator: Net loss $ (5,739,366) $ (7,339,665) Net loss attributable to common stockholders $ (5,739,366) $ (7,339,665) Denominator (weighted average quantities): Common shares issued 37,380,976 28,032,758 Add: Prefunded warrants — 1,870,130 Add: Undelivered vested restricted shares 29,611 105,306 Denominator for basic and diluted net loss per share 37,410,587 30,008,194 Basic and diluted net loss per common share $ (0.15) $ (0.24) The following securities are excluded from the calculation of weighted average diluted common shares because their inclusion would have been anti-dilutive: March 31, 2023 2022 Options 5,460,099 4,774,473 Warrants 6,087,845 7,957,975 Restricted stock units 150,578 115,329 Total potentially dilutive shares 11,698,522 12,847,777 |
Clinical Supply Arrangements | Clinical Supply Arrangements Bausch + Lomb, Inc. (“B+L”) and Arctic Vision (Hong Kong) Limited (“Arctic Vision”) have contracted with the Company to manufacture and supply them with the appropriate drug-device combination products to conduct their clinical trials on a cost plus 10% mark-up basis. The Company’s licensing agreements with B+L and Arctic Vision represent collaborative arrangements and they are not a customer with respect to the clinical supply arrangements. The Company’s policy is to (a) defer the materials and manufacturing costs in order to properly match them up against the income from the clinical supply arrangements; and (b) to report the net income from the clinical supply arrangements as other income. |
Recently Adopted Accounting Standards | Recently Adopted Accounting Standards In June 2016, the FASB issued ASU No. 2016-13, “Financial Instruments - Credit Losses (Topic 326)” and also issued subsequent amendments to the initial guidance under ASU 2018-19, ASU 2019-04 and ASU 2019-05 (collectively, “Topic 326”). Topic 326 requires the measurement and recognition of expected credit losses for financial assets held at amortized cost. This replaces the existing incurred loss model with an expected loss model and requires the use of forward-looking information to calculate credit loss estimates. The Company adopted ASU 2016-13 on January 1, 2023. The adoption of ASU 2016-13 did not have a material impact on the Company’s financial position, results of operations or cash flows. In August 2020, the FASB issued ASU 2020-06, “Debt—Debt with Conversion and Other Options (Subtopic 470-20)” and “Derivatives and Hedging— Contracts in Entity’s Own Equity (Subtopic 815-40): Accounting for Convertible Instruments and Contracts in an Entity’s Own Equity”, to clarify the accounting for certain financial instruments with characteristics of liabilities and equity. The amendments in this update reduce the number of accounting models for convertible debt instruments and convertible preferred stock by removing the cash conversion model and the beneficial conversion feature model. Limiting the accounting models will result in fewer embedded conversion features being separately recognized from the host contract. Convertible instruments that continue to be subject to separation models are (1) those with embedded conversion features that are not clearly and closely related to the host contract, that meet the definition of a derivative, and that do not qualify for a scope exception from derivative accounting and (2) convertible debt instruments issued with substantial premiums for which the premiums are recorded as paid-in-capital. In addition, ASU 2020-06 improves disclosure requirements for convertible instruments and earnings-per-share guidance. ASU 2020-06 also revises the derivative scope exception guidance to reduce form-over-substance-based accounting conclusions driven by remote contingent events. The amendments in this update are effective for the Company in fiscal years beginning after December 15, 2023, and interim periods within those fiscal years. Early adoption is permitted. The Company early adopted ASU 2020-06 effective January 1, 2023 which eliminates the need to assess whether a beneficial conversion feature needs to be recognized upon the issuance of new convertible instruments. The adoption of ASU 2020-06 did not have a material impact on the Company’s financial position, results of operations or cash flows. |
Going Concern and Summary of _3
Going Concern and Summary of Significant Accounting Policies (Tables) | 3 Months Ended |
Mar. 31, 2023 | |
Going Concern and Summary of Significant Accounting Policies | |
Schedule of computation of basic and diluted net loss per common share | For the Three Months Ended March 31, 2023 2022 Numerator: Net loss $ (5,739,366) $ (7,339,665) Net loss attributable to common stockholders $ (5,739,366) $ (7,339,665) Denominator (weighted average quantities): Common shares issued 37,380,976 28,032,758 Add: Prefunded warrants — 1,870,130 Add: Undelivered vested restricted shares 29,611 105,306 Denominator for basic and diluted net loss per share 37,410,587 30,008,194 Basic and diluted net loss per common share $ (0.15) $ (0.24) |
Schedule of weighted average diluted common shares | March 31, 2023 2022 Options 5,460,099 4,774,473 Warrants 6,087,845 7,957,975 Restricted stock units 150,578 115,329 Total potentially dilutive shares 11,698,522 12,847,777 |
Prepaid Expenses and Other Cu_2
Prepaid Expenses and Other Current Assets (Tables) | 3 Months Ended |
Mar. 31, 2023 | |
Prepaid Expenses and Other Current Assets | |
Schedule of prepaid expenses and other current assets | March 31, December 31, 2023 2022 Prepaid insurance expenses $ 803,486 $ 201,082 Payroll tax receivable 645,566 660,891 Prepaid general and administrative expenses 176,935 87,982 Prepaid conference expenses 132,026 97,743 Prepaid board of directors fees 106,250 — Prepaid patent expenses 61,569 38,796 Prepaid rent and security deposit 18,750 74,959 Prepaid research and development expenses 13,006 2,521 Other 54,296 26,745 Total prepaid expenses and other current assets $ 2,011,884 $ 1,190,719 |
Accrued Compensation (Tables)
Accrued Compensation (Tables) | 3 Months Ended |
Mar. 31, 2023 | |
Accrued Compensation | |
Schedule of accrued compensation | March 31, December 31, 2023 2022 Accrued bonus expenses $ 330,500 $ 1,447,643 Accrued payroll expenses 306,689 299,548 Total accrued compensation $ 637,189 $ 1,747,191 |
Accrued Expenses and Other Cu_2
Accrued Expenses and Other Current Liabilities (Tables) | 3 Months Ended |
Mar. 31, 2023 | |
Accrued Expenses and Other Current Liabilities | |
Schedule of accrued expenses and other current liabilities | March 31, December 31, 2023 2022 Accrued consulting and professional services $ 325,886 $ 320,000 Accrued research and development expenses 59,090 35,524 Other 24,537 4,385 Credit card payable 22,286 50,639 Accrued travel and entertainment expenses 15,244 — Accrued franchise tax 13,100 — Accrued leasehold improvements — 92,528 Total accrued expenses and other current liabilities $ 460,143 $ 503,076 |
Notes Payable (Tables)
Notes Payable (Tables) | 3 Months Ended |
Mar. 31, 2023 | |
Notes Payable | |
Schedule of notes payable | March 31, 2023 December 31, 2022 Notes Payable Debt Discount Net Notes Payable Debt Discount Net D&O insurance policy loan $ 509,110 $ — $ 509,110 $ — $ — $ — Avenue - Note payable 5,212,500 (772,369) 4,440,131 5,212,500 (847,114) 4,365,386 Avenue - Convertible note payable 5,212,500 (772,369) 4,440,131 5,212,500 (847,114) 4,365,386 Total 10,934,110 (1,544,738) 9,389,372 10,425,000 (1,694,228) 8,730,772 Current portion D&O insurance policy loan 509,110 — 509,110 — — — Avenue - Note payable 833,333 (123,480) 709,853 208,333 (33,885) 174,448 Avenue - Convertible note payable 833,333 (123,480) 709,853 208,333 (33,885) 174,448 Notes Payable, Current 2,175,776 (246,960) 1,928,816 416,666 (67,770) 348,896 Notes Payable, Non-Current $ 8,758,334 $ (1,297,778) $ 7,460,556 $ 10,008,334 $ (1,626,458) $ 8,381,876 |
Commitments and Contingencies (
Commitments and Contingencies (Tables) | 3 Months Ended |
Mar. 31, 2023 | |
Commitments and Contingencies | |
Summary of company's right-of-use assets and liabilities | For the Three Months Ended March 31, 2023 Cash paid for amounts included in the measurement of lease liabilities: Operating cash flows used in operating activities $ 136,150 Right-of-use assets obtained in exchange for lease obligations Operating leases $ 350,473 Weighted Average Remaining Lease Term (Years) Operating leases 3.50 years Weighted Average Discount Rate Operating leases 10.0 % |
Schedule of future minimum operating lease payments | For the Year Ending December 31, Minimum Lease Payments 2023 $ 482,350 2024 480,984 2025 429,992 2026 308,839 2027 214,619 Total future minimum lease payments 1,916,784 Less: amount representing imputed interest (309,935) Present value of lease liabilities 1,606,849 Less: current portion (472,901) Lease liabilities, non current portion $ 1,133,948 |
Stockholders' Equity (Tables)
Stockholders' Equity (Tables) | 3 Months Ended |
Mar. 31, 2023 | |
Stockholders' Equity | |
Schedule of Restricted Stock Units activity | Weighted Average Number of Grant Date Value RSUs Per Share RSUs non-vested January 1, 2023 172,800 $ 1.80 Granted — — Vested — — Forfeited (22,222) 1.80 RSUs non-vested March 31, 2023 150,578 $ 1.80 Vested RSUs undelivered March 31, 2023 29,611 $ 3.68 |
Schedule of Black-Scholes option pricing model to stock options granted | For the Three Months Ended March 31, 2023 2022 Expected term (years) 5.85 - 10.00 0.58 - 10.00 Risk free interest rate 3.60% - 4.18% 0.76% - 1.98% Expected volatility 82% - 83% 82% - 90% Expected dividends 0.00% 0.00% |
Summary of the option activity | Average Remaining Aggregate Number of Exercise Life Intrinsic Options Price In Years Value Outstanding as of January 1, 2023 5,380,553 $ 3.55 Granted 441,235 2.22 Exercised (73,334) 1.56 Forfeited (288,355) 3.68 Outstanding as of March 31, 2023 5,460,099 $ 3.52 7.2 $ 4,358,468 Exercisable as of March 31, 2023 3,933,774 $ 3.78 6.3 $ 2,398,462 |
Schedule of information related to stock options | The following table presents information related to stock options as of March 31, 2023: Options Outstanding Options Exercisable Weighted Outstanding Average Exercisable Exercise Number of Remaining Life Number of Price Options In Years Options $1.00 - $1.99 1,487,183 3.6 754,302 $2.00 - $2.99 1,360,358 7.2 938,202 $3.00 - $3.99 1,056,008 6.9 944,246 $4.00 - $4.99 364,581 8.3 220,684 $5.00 - $5.99 84,137 6.1 83,972 $6.00 - $6.99 942,914 6.7 827,450 $7.00 + 164,918 5.0 164,918 5,460,099 6.3 3,933,774 |
Going Concern and Summary of _4
Going Concern and Summary of Significant Accounting Policies - Anti-dilutive weighted average diluted common shares (Details) - USD ($) | 3 Months Ended | |
Mar. 31, 2023 | Mar. 31, 2022 | |
Going Concern and Summary of Significant Accounting Policies | ||
Total potentially dilutive shares | 11,698,522 | 12,847,777 |
Numerator: | ||
Net loss | $ (5,739,366) | $ (7,339,665) |
Net loss attributable to common stockholders | $ (5,739,366) | $ (7,339,665) |
Denominator (weighted average quantities): | ||
Common shares issued | 37,380,976 | 28,032,758 |
Add: Prefunded warrants | 1,870,130 | |
Add: Undelivered vested restricted shares | 29,611 | 105,306 |
Denominator for basic net loss per share | 37,410,587 | 30,008,194 |
Denominator for diluted net loss per share | 37,410,587 | 30,008,194 |
Basic net loss per share of common stock | $ (0.15) | $ (0.24) |
Diluted net loss per share of common stock | $ (0.15) | $ (0.24) |
Options | ||
Going Concern and Summary of Significant Accounting Policies | ||
Total potentially dilutive shares | 5,460,099 | 4,774,473 |
Warrants | ||
Going Concern and Summary of Significant Accounting Policies | ||
Total potentially dilutive shares | 6,087,845 | 7,957,975 |
Restricted stock units | ||
Going Concern and Summary of Significant Accounting Policies | ||
Total potentially dilutive shares | 150,578 | 115,329 |
Going Concern and Summary of _5
Going Concern and Summary of Significant Accounting Policies - Additional Information (Details) - USD ($) | 3 Months Ended | 9 Months Ended | ||||
Mar. 10, 2023 | Mar. 31, 2023 | Mar. 31, 2022 | Sep. 30, 2021 | Dec. 31, 2023 | Dec. 31, 2022 | |
Going Concern and Summary of Significant Accounting Policies | ||||||
Cash and cash equivalents | $ 18,466,322 | $ 26,716,269 | $ 22,863,520 | |||
Accumulated deficit | (123,969,829) | (118,230,463) | ||||
Net loss | (5,739,366) | (7,339,665) | ||||
Cash used in operations | (6,958,708) | $ (8,184,399) | $ (8,200,000) | |||
Treasury bills | 15,910,834 | |||||
Cash, uninsured amount | $ 2,055,488 | 22,613,520 | ||||
Net proceeds (in shares) | 1,299,947 | |||||
Operating lease right-of-use asset | $ 1,508,158 | 1,291,592 | ||||
Lease liabilities, non current portion | 1,133,948 | $ 1,133,948,000 | 907,644 | |||
Deferred clinical supply costs | $ 3,352,645 | $ 2,284,931 | ||||
Stock Issued During Period, Shares, New Issues | 1,299,947 | |||||
Clinical Supply Arrangements | ||||||
Going Concern and Summary of Significant Accounting Policies | ||||||
Clinical trials, percentage of additional mark-up on cost | 10% | |||||
Securities purchase agreement | ||||||
Going Concern and Summary of Significant Accounting Policies | ||||||
Net proceeds (in shares) | 250,000 | |||||
Stock Issued During Period, Shares, New Issues | 250,000 | |||||
Securities purchase agreement | Silicon Valley Bank loan | Pre-funded warrants | ||||||
Going Concern and Summary of Significant Accounting Policies | ||||||
Cash and cash equivalents | $ 305,000 |
Prepaid Expenses and Other Cu_3
Prepaid Expenses and Other Current Assets (Details) - USD ($) | Mar. 31, 2023 | Dec. 31, 2022 |
Prepaid Expenses and Other Current Assets | ||
Prepaid insurance expenses | $ 803,486 | $ 201,082 |
Payroll tax receivable | 645,566 | 660,891 |
Prepaid general and administrative expenses | 176,935 | 87,982 |
Prepaid conference expenses | 132,026 | 97,743 |
Prepaid board of directors fees | 106,250 | 0 |
Prepaid patent expenses | 61,569 | 38,796 |
Prepaid rent and security deposit | 18,750 | 74,959 |
Prepaid research and development expenses | 13,006 | 2,521 |
Other | 54,296 | 26,745 |
Total prepaid expenses and other current assets | $ 2,011,884 | $ 1,190,719 |
Accrued Compensation (Details)
Accrued Compensation (Details) - USD ($) | Mar. 31, 2023 | Dec. 31, 2022 |
Accrued Compensation | ||
Accrued bonus expenses | $ 330,500 | $ 1,447,643 |
Accrued payroll expenses | 306,689 | 299,548 |
Total accrued compensation | $ 637,189 | $ 1,747,191 |
Accrued Expenses and Other Cu_3
Accrued Expenses and Other Current Liabilities (Details) - USD ($) | Mar. 31, 2023 | Dec. 31, 2022 |
Accrued Expenses and Other Current Liabilities | ||
Accrued consulting and professional services | $ 325,886 | $ 320,000 |
Accrued research and development expenses | 59,090 | 35,524 |
Other | 24,537 | 4,385 |
Credit card payable | 22,286 | 50,639 |
Accrued travel and entertainment expenses | 15,244 | 0 |
Accrued franchise tax | 13,100 | 0 |
Accrued leasehold improvements | 0 | 92,528 |
Total accrued expenses and other current liabilities | $ 460,143 | $ 503,076 |
Notes Payable - Schedule of not
Notes Payable - Schedule of notes payable (Details) - USD ($) | Mar. 31, 2023 | Dec. 31, 2022 |
Notes Payable | ||
Notes Payable, Total | $ 10,934,110 | $ 10,425,000 |
Debt Discount, Total | (1,544,738) | (1,694,228) |
Net, Total | 9,389,372 | 8,730,772 |
Current portion | ||
Notes Payable, Current portion | 2,175,776 | 416,666 |
Debt Discount, Current portion | (246,960) | (67,770) |
Net, Current portion | 1,928,816 | 348,896 |
Note payable, Non Current portion | 8,758,334 | 10,008,334 |
Debt Discount, Non-Current portion | (1,297,778) | (1,626,458) |
Net, Non Current portion | 7,460,556 | 8,381,876 |
D&O insurance policy loan | ||
Notes Payable | ||
Notes Payable, Total | 509,110 | 0 |
Debt Discount, Total | 0 | 0 |
Net, Total | 509,110 | 0 |
Current portion | ||
Notes Payable, Current portion | 509,110 | 0 |
Debt Discount, Current portion | 0 | 0 |
Net, Current portion | 509,110 | 0 |
Avenue - Note payable | ||
Notes Payable | ||
Notes Payable, Total | 5,212,500 | 5,212,500 |
Debt Discount, Total | (772,369) | (847,114) |
Net, Total | 4,440,131 | 4,365,386 |
Current portion | ||
Notes Payable, Current portion | 833,333 | 208,333 |
Debt Discount, Current portion | (123,480) | (33,885) |
Net, Current portion | 709,853 | 174,448 |
Avenue - Convertible note payable | ||
Notes Payable | ||
Notes Payable, Total | 5,212,500 | 5,212,500 |
Debt Discount, Total | (772,369) | (847,114) |
Net, Total | 4,440,131 | 4,365,386 |
Current portion | ||
Notes Payable, Current portion | 833,333 | 208,333 |
Debt Discount, Current portion | (123,480) | (33,885) |
Net, Current portion | $ 709,853 | $ 174,448 |
Notes Payable - Additional Info
Notes Payable - Additional Information (Details) - USD ($) | 3 Months Ended | |||||
Feb. 24, 2022 | Mar. 31, 2023 | Mar. 31, 2022 | Aug. 24, 2023 | Feb. 24, 2023 | Dec. 31, 2022 | |
Notes Payable | ||||||
Short term notes payable | $ 1,218,963 | $ 174,448 | ||||
Repayments of notes payable | 100,030 | $ 111,793 | ||||
Amount pledged to establish and maintain a collateralized money market account | 7,875,000 | |||||
Interest expense | 145,237 | |||||
Avenue Ventures Loan | ||||||
Notes Payable | ||||||
Interest expense | 454,003 | |||||
Interest expense related to the Loan and Security Agreement with Avenue Capital Management | 450,394 | |||||
D&O insurance policy loan | ||||||
Notes Payable | ||||||
Short term notes payable | $ 609,140 | |||||
Interest rate (as a percent) | 7.11% | |||||
Number of monthly payments | 6 months | |||||
Debt Instrument, Periodic Payment | 103,639 | |||||
Loan issuance costs | 143,403 | |||||
Amortization of debt discount | 149,490 | |||||
Amortization of debt discount related to loans | $ 3,609 | |||||
Repayments of loans | $ 1,834 |
Commitments and Contingencies -
Commitments and Contingencies - Additional Information (Details) - Lease Agreement For Office Located In Redwood City, California [Member] | 1 Months Ended |
Feb. 28, 2023 ft² | |
Commitments and Contingencies | |
Net rentable area | 6,700 |
Lease expiration date | Aug. 31, 2023 |
Commitments and Contingencies_2
Commitments and Contingencies - Companys right-of-use assets and liabilities (Details) - USD ($) | 3 Months Ended | |
Mar. 31, 2023 | Mar. 31, 2022 | |
Commitments and Contingencies | ||
Cash paid for amounts included in the measurement of lease liabilities: Operating cash flows used in operating activities | $ 136,150 | |
Right-of-use assets obtained in exchange for lease obligations; Operating leases | $ 350,473 | $ 79,181 |
Weighted Average Remaining Lease Term (Years): Operating leases | 3 years 6 months | |
Weighted Average Discount Rate: Operating leases | 10% |
Commitments and Contingencies_3
Commitments and Contingencies - Future Minimum Payments under Operating Lease Agreement (Details) - USD ($) | Dec. 31, 2023 | Mar. 31, 2023 | Dec. 31, 2022 |
Minimum Lease Payments | |||
2023 | $ 482,350,000 | ||
2024 | 480,984,000 | ||
2025 | 429,992,000 | ||
2026 | 308,839,000 | ||
2027 | 214,619,000 | ||
Total future minimum lease payments | 1,916,784,000 | ||
Less: amount representing imputed interest | (309,935,000) | ||
Present value of lease liabilities | 1,606,849,000 | ||
Less: current portion | (472,901,000) | $ (472,901) | $ (484,882) |
Lease liabilities - non-current portion | $ 1,133,948,000 | $ 1,133,948 | $ 907,644 |
Stockholders' Equity - Restrict
Stockholders' Equity - Restricted stock units activity (Details) | 3 Months Ended |
Mar. 31, 2023 $ / shares shares | |
Number of RSUs | |
RSUs non-vested at beginning of period | shares | 172,800 |
Forfeited | shares | (22,222) |
RSUs non-vested at end of the period | shares | 150,578 |
Vested RSUs undelivered | shares | 29,611 |
Weighted Average Grant Date Value Per Share | |
RSUs non-vested January 1, 2023 | $ / shares | $ 1.80 |
Forfeited | $ / shares | 1.80 |
RSUs non-vested December 31, 2023 | $ / shares | 1.80 |
Vested RSUs undelivered September 30, 2023 | $ / shares | $ 3.68 |
Stockholders' Equity - Black Sc
Stockholders' Equity - Black Scholes option (Details) | 3 Months Ended | |
Mar. 31, 2023 | Mar. 31, 2022 | |
Stockholders' Equity | ||
Expected dividends | 0% | 0% |
Minimum | ||
Stockholders' Equity | ||
Expected term (years) | 5 years 10 months 6 days | 6 months 29 days |
Risk free interest rate | 3.60% | 0.76% |
Expected volatility | 82% | 82% |
Maximum | ||
Stockholders' Equity | ||
Expected term (years) | 10 years | 10 years |
Risk free interest rate | 4.18% | 1.98% |
Expected volatility | 83% | 90% |
Stockholders' Equity - Summary
Stockholders' Equity - Summary of option activity (Details) - USD ($) | 3 Months Ended | |
Jan. 25, 2023 | Mar. 31, 2023 | |
Stockholders' Equity | ||
Number of Options, Exercised | Shares | (73,334) | |
Stock Options | ||
Stockholders' Equity | ||
Number of Options, Outstanding | Shares | 5,380,553 | |
Number of Options, Granted | Shares | 441,235 | |
Number of Options, Exercised | Shares | (73,334) | |
Number of Options, Forfeited | Shares | (288,355) | |
Number of Options, Outstanding | Shares | 5,460,099 | |
Number of Options, Exercisable | Shares | 3,933,774 | |
Weighted Average Exercise Price, Outstanding | $ / Shares | $ 3.55 | |
Weighted Average Exercise Price, Granted | $ / Shares | 2.22 | |
Weighted Average Exercise Price, Exercised | $ / Shares | 1.56 | |
Weighted Average Exercise Price, Forfeited | $ / Shares | 3.68 | |
Weighted Average Exercise Price, Outstanding | $ / Shares | 3.52 | |
Weighted Average Exercise Price, Exercisable | $ / Shares | $ 3.78 | |
Remaining Life In Years, Outstanding | 7 years 2 months 12 days | |
Remaining Life In Years, Exercisable | 6 years 3 months 18 days | |
Aggregate Intrinsic Value, Outstanding | $ | $ 4,358,468 | |
Aggregate Intrinsic Value, Exercisable | $ 2,398,462 |
Stockholders' Equity - Summar_2
Stockholders' Equity - Summary of information related to stock options (Details) | 3 Months Ended |
Mar. 31, 2023 $ / shares shares | |
Stockholders' Equity | |
Options Outstanding, Outstanding Number of Options | 5,460,099 |
Options Exercisable, Weighted Average Remaining Life In Years | 6 years 3 months 18 days |
Options Exercisable, Exercisable Number of Options | 3,933,774 |
Exercise Price $1.00 - $1.99 | |
Stockholders' Equity | |
Options Outstanding, Outstanding Number of Options | 1,487,183 |
Options Exercisable, Weighted Average Remaining Life In Years | 3 years 7 months 6 days |
Options Exercisable, Exercisable Number of Options | 754,302 |
Exercise Price $1.00 - $1.99 | Minimum | |
Stockholders' Equity | |
Options Outstanding, Outstanding Exercise Price | $ / shares | $ 1 |
Exercise Price $1.00 - $1.99 | Maximum | |
Stockholders' Equity | |
Options Outstanding, Outstanding Exercise Price | $ / shares | $ 1.99 |
Exercise Price $2.00 - $2.99 | |
Stockholders' Equity | |
Options Outstanding, Outstanding Number of Options | 1,360,358 |
Options Exercisable, Weighted Average Remaining Life In Years | 7 years 2 months 12 days |
Options Exercisable, Exercisable Number of Options | 938,202 |
Exercise Price $2.00 - $2.99 | Minimum | |
Stockholders' Equity | |
Options Outstanding, Outstanding Exercise Price | $ / shares | $ 2 |
Exercise Price $2.00 - $2.99 | Maximum | |
Stockholders' Equity | |
Options Outstanding, Outstanding Exercise Price | $ / shares | $ 2.99 |
Exercise Price $3.00 - $3.99 | |
Stockholders' Equity | |
Options Outstanding, Outstanding Number of Options | 1,056,008 |
Options Exercisable, Weighted Average Remaining Life In Years | 6 years 10 months 24 days |
Options Exercisable, Exercisable Number of Options | 944,246 |
Exercise Price $3.00 - $3.99 | Minimum | |
Stockholders' Equity | |
Options Outstanding, Outstanding Exercise Price | $ / shares | $ 3 |
Exercise Price $3.00 - $3.99 | Maximum | |
Stockholders' Equity | |
Options Outstanding, Outstanding Exercise Price | $ / shares | $ 3.99 |
Exercise Price $4.00 - $4.99 | |
Stockholders' Equity | |
Options Outstanding, Outstanding Number of Options | 364,581 |
Options Exercisable, Weighted Average Remaining Life In Years | 8 years 3 months 18 days |
Options Exercisable, Exercisable Number of Options | 220,684 |
Exercise Price $4.00 - $4.99 | Minimum | |
Stockholders' Equity | |
Options Outstanding, Outstanding Exercise Price | $ / shares | $ 4 |
Exercise Price $4.00 - $4.99 | Maximum | |
Stockholders' Equity | |
Options Outstanding, Outstanding Exercise Price | $ / shares | $ 4.99 |
Exercise Price $5.00 - $5.99 | |
Stockholders' Equity | |
Options Outstanding, Outstanding Number of Options | 84,137 |
Options Exercisable, Weighted Average Remaining Life In Years | 6 years 1 month 6 days |
Options Exercisable, Exercisable Number of Options | 83,972 |
Exercise Price $5.00 - $5.99 | Minimum | |
Stockholders' Equity | |
Options Outstanding, Outstanding Exercise Price | $ / shares | $ 5 |
Exercise Price $5.00 - $5.99 | Maximum | |
Stockholders' Equity | |
Options Outstanding, Outstanding Exercise Price | $ / shares | $ 5.99 |
Exercise Price $6.00 - $6.99 | |
Stockholders' Equity | |
Options Outstanding, Outstanding Number of Options | 942,914 |
Options Exercisable, Weighted Average Remaining Life In Years | 6 years 8 months 12 days |
Options Exercisable, Exercisable Number of Options | 827,450 |
Exercise Price $6.00 - $6.99 | Minimum | |
Stockholders' Equity | |
Options Outstanding, Outstanding Exercise Price | $ / shares | $ 6 |
Exercise Price $6.00 - $6.99 | Maximum | |
Stockholders' Equity | |
Options Outstanding, Outstanding Exercise Price | $ / shares | 6.99 |
Exercise Price $7.00+ | |
Stockholders' Equity | |
Options Outstanding, Outstanding Exercise Price | $ / shares | $ 7 |
Options Outstanding, Outstanding Number of Options | 164,918 |
Options Exercisable, Weighted Average Remaining Life In Years | 5 years |
Options Exercisable, Exercisable Number of Options | 164,918 |
Stockholders' Equity - Addition
Stockholders' Equity - Additional Information (Details) - USD ($) | 3 Months Ended | |||||
Mar. 10, 2023 | Feb. 28, 2023 | Jan. 25, 2023 | Mar. 31, 2023 | Mar. 31, 2022 | Dec. 31, 2022 | |
Stockholders' Equity | ||||||
Common stock, shares authorized | 90,000,000 | 90,000,000 | ||||
Common Stock, par value | $ 0.0001 | $ 0.0001 | ||||
Preferred stock, shares authorized | 6,000,000 | 6,000,000 | ||||
Preferred stock, par value | $ 0.0001 | $ 0.0001 | ||||
Net proceeds (in shares) | 1,299,947 | |||||
Stock-based compensation | $ 819,064 | $ 908,987 | ||||
Unrecognized stock - based compensation expense | $ 3,228,544 | |||||
Weighted average period of recognition | 1 year 7 months 6 days | |||||
Stock-based compensation | $ 819,064 | 908,987 | ||||
Number Of Shares Issued Upon Exercise Of Stock Options | 19,530 | |||||
Cashless exercise of stock options (in shares) | 73,334 | |||||
Net proceeds | 3,500,000 | |||||
Securities purchase agreement | ||||||
Stockholders' Equity | ||||||
Net proceeds (in shares) | 250,000 | |||||
Research and Development Expense. | ||||||
Stockholders' Equity | ||||||
Stock-based compensation | 501,181 | 375,130 | ||||
General and Administrative Expense | ||||||
Stockholders' Equity | ||||||
Stock-based compensation | 443,934 | $ 407,806 | ||||
Restricted stock units | ||||||
Stockholders' Equity | ||||||
Resignation of common stock RSU | 3,289 | |||||
Unrecognized stock - based compensation expense | $ 62,079 | |||||
Weighted average period of recognition | 3 months 18 days | |||||
Options | ||||||
Stockholders' Equity | ||||||
Weighted average estimated grant date fair value | $ 1.61 | $ 2.28 | ||||
Common Stock | ||||||
Stockholders' Equity | ||||||
Resignation of common stock RSU | 3,289 | 19,359 | ||||
Cashless exercise of stock options (in shares) | 19,530 |
Employee Benefit Plans (Details
Employee Benefit Plans (Details) - USD ($) | 1 Months Ended | 3 Months Ended | |
Apr. 30, 2019 | Mar. 31, 2023 | Mar. 31, 2022 | |
Employee Benefit Plans | |||
Defined contribution plan, employer matching contribution, percent of match | 100% | ||
Defined contribution plan, employers matching contribution, annual vesting percentage | 4% | ||
Defined contribution plan, maximum annual contributions per employee, amount | $ 78,969 | $ 86,099 |