Document and Entity Information
Document and Entity Information - USD ($) | 12 Months Ended | ||
Dec. 31, 2022 | Mar. 28, 2023 | Jun. 30, 2022 | |
Document and Entity Information | |||
Document Type | 10-K | ||
Document Annual Report | true | ||
Document Period End Date | Dec. 31, 2022 | ||
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, Address Line One | 295 Madison Avenue | ||
Entity Address, Address Line Two | Suite 2400 | ||
Entity Address, City or Town | NEW YORK | ||
Entity Address, State or Province | NY | ||
Entity Address, Postal Zip Code | 10017 | ||
City Area Code | 833 | ||
Local Phone Number | 393-6684 | ||
Title of 12(b) Security | Common Stock, $0.0001 Par Value | ||
Trading Symbol | EYEN | ||
Security Exchange Name | NASDAQ | ||
Entity Well-known Seasoned Issuer | No | ||
Entity Voluntary Filers | No | ||
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 | ||
ICFR Auditor Attestation Flag | false | ||
Entity Shell Company | false | ||
Auditor Firm ID | 688 | ||
Auditor Name | Marcum LLP | ||
Auditor Location | New York, NY | ||
Entity Public Float | $ 53,095,760 | ||
Entity Common Stock, Shares Outstanding | 37,991,746 | ||
Entity Central Index Key | 0001682639 | ||
Current Fiscal Year End Date | --12-31 | ||
Document Fiscal Year Focus | 2022 | ||
Document Fiscal Period Focus | FY | ||
Amendment Flag | false |
Balance Sheets
Balance Sheets - USD ($) | Dec. 31, 2022 | Dec. 31, 2021 |
Current Assets: | ||
Cash and cash equivalents | $ 22,863,520 | $ 19,461,850 |
Deferred clinical supply costs | 2,284,931 | |
License fee and expense reimbursements receivable | 1,183,786 | 1,805,065 |
Security deposits, current | 119,550 | |
Prepaid expenses and other current assets | 1,190,719 | 734,942 |
Total Current Assets | 27,642,506 | 22,001,857 |
Restricted cash | 7,875,000 | |
Property and equipment, net | 1,295,115 | 1,271,225 |
Security deposits, non-current | 80,874 | 119,035 |
Operating lease right-of-use asset | 1,291,592 | |
Equipment deposits | 726,326 | 391,941 |
Total Assets | 31,036,413 | 31,659,058 |
Current Liabilities: | ||
Accounts payable | 1,428,283 | 1,614,104 |
Accrued compensation | 1,747,191 | 1,543,618 |
Accrued expenses and other current liabilities | 503,076 | 845,719 |
Deferred rent - current portion | 18,685 | |
Operating lease liabilities - current portion | 484,882 | |
Notes payable - current portion, net of debt discount of $33,885 and $349,632 as of December 31, 2022 and 2021, respectively | 174,448 | 7,150,368 |
Convertible notes payable - current portion, net of debt discount of $33,885 and $0 as of December 31, 2022 and 2021, respectively | 174,448 | |
Total Current Liabilities | 4,512,328 | 11,172,494 |
Deferred rent - non-current portion | 19,949 | |
Operating lease liabilities - non-current portion | 907,644 | |
Notes payable - non-current portion, net of debt discount of $813,229 and $0 as of December 31, 2022 and 2021, respectively | 4,190,938 | |
Convertible notes payable - non-current portion, net of debt discount of $813,229 and $0 as of December 31, 2022 and 2021, respectively | 4,190,938 | |
Total Liabilities | 13,801,848 | 11,192,443 |
Commitments and contingencies | ||
Stockholders' Equity: | ||
Preferred stock, $0.0001 par value, 6,000,000 shares authorized; 0 shares issued and outstanding as of December 31, 2022 and 2021, respectively | 0 | 0 |
Common stock, $0.0001 par value, 90,000,000 shares authorized; 36,668,980 and 28,426,616 shares issued and outstanding as of December 31, 2022 and 2021, respectively | 3,667 | 2,844 |
Additional paid-in capital | 135,461,361 | 110,683,077 |
Accumulated deficit | (118,230,463) | (90,219,306) |
Total Stockholders' Equity | 17,234,565 | 20,466,615 |
Total Liabilities and Stockholders' Equity | $ 31,036,413 | $ 31,659,058 |
Balance Sheets (Parenthetical)
Balance Sheets (Parenthetical) - USD ($) | Dec. 31, 2022 | Dec. 31, 2021 |
Balance Sheets | ||
Notes payable - current portion, debt discount | $ 33,885 | $ 349,632 |
Convertible notes payable - current portion, debt discount | 33,885 | 0 |
Notes payable - non-current portion, debt discount | 813,229 | 0 |
Convertible notes payable - non-current portion, debt discount | $ 813,229 | $ 0 |
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 | 36,668,980 | 28,426,616 |
Common stock, shares outstanding | 36,668,980 | 28,426,616 |
Statements of Operations
Statements of Operations - USD ($) | 12 Months Ended | |
Dec. 31, 2022 | Dec. 31, 2021 | |
Operating Income | ||
Revenue | $ 14,000,000 | |
Cost of revenue | (1,600,000) | |
Gross Profit | 12,400,000 | |
Operating Expenses: | ||
Research and development | $ 13,378,680 | 14,850,874 |
General and administrative | 13,532,835 | 10,569,653 |
Total Operating Expenses | 26,911,515 | 25,420,527 |
Loss From Operations | (26,911,515) | (13,020,527) |
Other Income (Expense): | ||
Extinguishment of PPP 7(a) loan | 0 | 463,353 |
Other income, net | 197,090 | 164,027 |
Interest expense | (1,380,058) | (387,756) |
Interest income | 83,326 | 2,516 |
Net Loss | $ (28,011,157) | $ (12,778,387) |
Net Loss Per Share | ||
Net Loss Per Share - Basic | $ (0.83) | $ (0.49) |
Net Loss Per Share - Diluted | $ (0.83) | $ (0.49) |
Weighted Average Number of Common Shares Outstanding | ||
Weighted Average Number of Common Shares Outstanding - Basic | 33,649,747 | 26,324,081 |
Weighted Average Number of Common Shares Outstanding - Diluted | 33,649,747 | 26,324,081 |
Statements of Changes in Stockh
Statements of Changes in Stockholders' Equity - USD ($) | Common Stock | Additional Paid-In Capital | Accumulated Deficit | Total |
Balance at the beginning at Dec. 31, 2020 | $ 2,498 | $ 92,742,306 | $ (77,440,919) | $ 15,303,885 |
Balance at the beginning (in shares) at Dec. 31, 2020 | 24,978,585 | |||
Origination costs related to equity in debt financing | (3,149) | |||
Issuance of common stock in At the Market offering | $ 244 | 12,401,675 | 0 | 12,401,919 |
Issuance of common stock in At the Market offering (in shares) | 2,435,604 | |||
Exercise of stock warrants | $ 89 | 2,124,815 | 0 | 2,124,904 |
Exercise of stock warrants (in shares) | 885,482 | |||
Exercise of stock options | $ 12 | 203,114 | 0 | 203,126 |
Exercise of stock options (in shares) | 121,261 | |||
Shares withheld from option exercise for employee tax liability | $ (1) | (26,323) | 0 | (26,324) |
Shares withheld from option exercise for employee tax liability (in shares) | (13,675) | |||
Issuance of SVB warrants | $ 0 | 351,390 | 0 | 351,390 |
Stock-based compensation | 0 | 2,886,102 | 0 | 2,886,102 |
Issuance of common stock related to vested restricted stock units | $ 2 | (2) | 0 | 0 |
Issuance of common stock related to vested restricted stock units (in shares) | 19,359 | |||
Net loss | $ 0 | 0 | (12,778,387) | (12,778,387) |
Balance at the end at Dec. 31, 2021 | $ 2,844 | 110,683,077 | (90,219,306) | 20,466,615 |
Balance at the end (in shares) at Dec. 31, 2021 | 28,426,616 | |||
Issuance of common stock and warrants in direct offering | $ 300 | 14,897,608 | 0 | 14,897,908 |
Issuance of common stock and warrants in direct offering (in shares) | 3,000,000 | |||
Issuance of common stock in debt financing | $ 54 | 859,679 | 0 | 859,733 |
Issuance of common stock in debt financing (in shares) | 547,807 | |||
Origination costs related to equity in debt financing | $ 0 | (44,375) | 0 | (44,375) |
Issuance of common stock in At the Market offering | $ 271 | 5,281,505 | 0 | 5,281,776 |
Issuance of common stock in At the Market offering (in shares) | 2,716,061 | |||
Exercise of stock warrants | $ 187 | 18,514 | 0 | 18,701 |
Exercise of stock warrants (in shares) | 1,870,130 | |||
Stock-based compensation | $ 0 | 3,765,364 | 0 | 3,765,364 |
Issuance of common stock related to vested restricted stock units | $ 11 | (11) | 0 | 0 |
Issuance of common stock related to vested restricted stock units (in shares) | 108,366 | |||
Net loss | $ 0 | 0 | (28,011,157) | (28,011,157) |
Balance at the end at Dec. 31, 2022 | $ 3,667 | $ 135,461,361 | $ (118,230,463) | $ 17,234,565 |
Balance at the end (in shares) at Dec. 31, 2022 | 36,668,980 |
Statements of Changes in Stoc_2
Statements of Changes in Stockholders' Equity (Parenthetical) - USD ($) | 12 Months Ended | |
Dec. 31, 2022 | Dec. 31, 2021 | |
Proceeds of stock issued during period gross | $ 14,981,299 | |
Adjustments to additional paid in capital upon stock issuance costs | 44,375 | $ 3,149 |
Fair value of warrants | 354,539 | |
Common Stock One | ||
Proceeds of stock issued during period gross | 12,785,483 | |
Adjustments to additional paid in capital upon stock issuance costs | $ 383,564 | |
Common Stock Two | ||
Proceeds of stock issued during period gross | 14,981,299 | |
Adjustments to additional paid in capital upon stock issuance costs | 83,391 | |
Common Stock Three | ||
Proceeds of stock issued during period gross | 5,445,130 | |
Adjustments to additional paid in capital upon stock issuance costs | $ 163,354 |
Statements of Cash Flows
Statements of Cash Flows - USD ($) | 12 Months Ended | ||
Dec. 31, 2022 | Dec. 31, 2021 | ||
Cash Flows From Operating Activities | |||
Net loss | $ (28,011,157) | $ (12,778,387) | |
Adjustments to reconcile net loss to net cash used in operating activities: | |||
Stock-based compensation | 3,765,364 | 2,886,102 | |
Depreciation of property and equipment | 307,430 | 221,563 | |
Amortization of debt discount | 411,918 | 68,376 | |
Write-off of property and equipment | 209,040 | 0 | |
Gain on forgiveness of PPP 7(a) Loan | 0 | (463,353) | |
Non-cash rent expense | 474,778 | 0 | |
Expense reimbursement | 0 | (51,588) | |
Gain on disposal of property and equipment | 0 | (55,194) | |
Changes in operating assets and liabilities: | |||
Prepaid expenses and other current assets | 219,555 | 423,896 | |
License fee and expense reimbursements receivables | 621,279 | 1,397,924 | |
Deferred clinical supply costs | (2,284,931) | 0 | |
Deferred license costs | 0 | 1,600,000 | |
Security deposits | (81,389) | 0 | |
Accounts payable | (185,821) | 126,115 | |
Accrued compensation | 203,573 | 392,946 | |
Accrued expenses and other current liabilities | (342,643) | (634,973) | |
Deferred license fee | 0 | (14,000,000) | |
Deferred rent | 0 | (7,859) | |
Lease liabilities | (412,478) | ||
Net Cash Used In Operating Activities | (25,105,482) | (20,874,432) | |
Cash Flows From Investing Activities | |||
Purchases of property and equipment | (540,360) | (1,226,576) | |
Vendor deposits for property and equipment | (334,385) | (391,941) | |
Net Cash Used In Investing Activities | (874,745) | (1,618,517) | |
Cash Flows From Financing Activities | |||
Proceeds from sale of common stock and warrants in registered direct offering | [1] | 14,981,299 | 0 |
Payment of issuance costs in registered direct offering | (83,391) | 0 | |
Proceeds from sale of common stock in At the Market offering | 5,445,130 | 12,785,483 | |
Payment of issuance costs for At the Market offering | (163,354) | (383,564) | |
Proceeds from exercise of stock warrants | 18,701 | 2,124,904 | |
Proceeds from SVB loan | 0 | 7,500,000 | |
Payment of SVB loan issuance costs | 0 | (66,618) | |
Proceeds from notes and equity issued to Avenue | 10,000,000 | 0 | |
Payment of issuance costs for equity issued to Avenue | (46,836) | 0 | |
Payment of issuance costs for notes issued to Avenue | (469,320) | 0 | |
Repayments of notes payable | (8,175,332) | (705,360) | |
Proceeds from exercise of stock options | 0 | 203,126 | |
Net Cash Provided By Financing Activities | 21,506,897 | 21,457,971 | |
Net Decrease in Cash and Cash Equivalents | (4,473,330) | (1,034,978) | |
Cash and cash equivalents - Beginning of Year | 27,336,850 | 28,371,828 | |
Cash and cash equivalents - End of Year | 22,863,520 | 27,336,850 | |
Cash, cash equivalents and restricted cash consisted of the following: | |||
Cash and cash equivalents | 22,863,520 | 19,461,850 | |
Restricted cash | 7,875,000 | ||
Total | 22,863,520 | 27,336,850 | |
Supplemental Disclosure of Cash Flow Information: | |||
Interest | 315,550 | 227,171 | |
Supplemental Disclosure of Non-Cash Investing and Financing Activities | |||
Purchase of insurance premium financed by note payable | 675,332 | 705,360 | |
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 | 1,186,098 | ||
Shares withheld from option exercise for employee tax liability | 26,324 | ||
Warrants issued for debt issuance costs | 351,390 | ||
Common shares issued recorded as debt discount for Avenue Loan | 859,733 | ||
Issuance of common stock related to vested restricted stock units | $ 11 | $ 2 | |
[1]Includes gross proceeds of $14,981,299, of which $5,741,299 is pre-funded warrants. |
Statements of Cash Flows (Paren
Statements of Cash Flows (Parenthetical) | 12 Months Ended |
Dec. 31, 2022 USD ($) | |
Proceeds of stock issued during period gross | $ 14,981,299 |
Payments of debt issuance costs | 0 |
Pre-funded warrants | |
Proceeds of stock issued during period gross | $ 5,741,299 |
Business Organization and Natur
Business Organization and Nature of Operations | 12 Months Ended |
Dec. 31, 2022 | |
Business Organization and Nature of Operations | |
Business Organization and Nature of Operations | Note 1 – Business Organization and Nature of Operations Eyenovia, Inc., or Eyenovia or the Company, is a pre-commercial ophthalmic technology company developing the Optejet® delivery system for use both in combination with its own drug-device therapeutic programs as well as out-licensing for additional indications. Eyenovia’s aim is to improve the delivery of topical ophthalmic medication through ergonomic design that facilitates ease-of-use and delivery of more physiologically appropriate medication volume, with the goal to reduce side effects and improve tolerability, and introduce digital health technology to improve therapy compliance and ultimately medical outcomes. The ergonomic and functional design of the Optejet® allows for horizontal drug delivery and eliminates the need to tilt the head back or the manual dexterity to squeeze a bottle to administer medications. Drug is delivered in a microscopic array of droplets faster than the blink reflex to help ensure instillation success. The precise delivery of a low-volume columnar spray by the Optejet® device minimizes contamination with a non-protruding nozzle and self-closing shutter. In clinical trials, the Optejet® has demonstrated that its targeted delivery achieves a high rate of successful administration, with 98% of sprays being accurately delivered upon first attempt compared to the established rate reported with traditional eye drops of ~ 50%. A more physiologically appropriate volume of medication in the range of seven to nine microliters is delivered by the Optejet, approximately one fifth of the 35 to 50 microliter dose typically delivered in a single eye drop. Lower volume of medication exposes the ocular surface to less active ingredient and preservatives, potentially reducing ocular stress and surface damage and improving tolerability. The lower volume also minimizes the potential for drug to enter systemic circulation, with the goal of avoiding some common side effects that are related to overdosing of the eye. Versions of the Optejet are being developed with on-board digital technology to provide reminders via Bluetooth to smart devices and date and time stamp device use. This information can then be used by practitioners and health care systems to measure treatment compliance and improve medical decision making. In this way, the Optejet could serve as an extension of the physician’s office by providing information that is not currently possible to collect except through the use of diaries. To address unmet medical needs, the Company is developing the next generation of smart ophthalmic therapeutics to target new indications or new combinations where there are currently no or few drug therapies approved by the U.S. Food and Drug Administration, or FDA. The Company’s investigational products are classified by the 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. |
Summary of Significant Accounti
Summary of Significant Accounting Policies | 12 Months Ended |
Dec. 31, 2022 | |
Summary of Significant Accounting Policies | |
Summary of Significant Accounting Policies | Liquidity and Going Concern As of December 31, 2022, the Company had unrestricted cash and cash equivalents of approximately $22.9 million and an accumulated deficit of approximately $118.2 million. For the years ended December 31, 2022 and 2021, the Company incurred net losses of approximately $28.0 million and $12.8 million, respectively, and used cash in operations of approximately $25.1 million and $20.9 million, respectively. The Company does not have recurring revenue and has not yet achieved profitability. The Company expects to continue to incur cash outflows from operations for the near future. 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 generate sufficient recurring revenues or 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 its product and service offerings. If the Company is unable to generate sufficient recurring revenues or secure additional capital, it may be required to curtail its research and development initiatives and take additional measures to reduce costs in order to conserve its cash. Use of Estimates Preparation of financial statements in conformity with accounting principles generally accepted in the United States of America, or U.S. GAAP, requires management to make estimates, judgments and assumptions that affect the amounts reported in the financial statements and the amounts disclosed in the related notes to the financial statements. The Company bases its estimates and judgments on historical experience and on various other assumptions that it believes are reasonable under the circumstances. The amounts of assets and liabilities reported in the Company’s balance sheets and the amounts of expenses reported for each of the periods presented are affected by estimates and assumptions, which are used for, but not limited to, fair value calculations for equity securities, establishment of valuation allowances for deferred tax assets, revenue recognition, the recoverability and useful lives of long-lived assets, the recovery of deferred costs and the deferral of revenues. Certain of the Company’s estimates could be affected by external conditions, including those unique to the Company and general economic conditions. It is reasonably possible that actual results could differ from those estimates. See Note 2 - Summary of Significant Accounting Policies — Stock-Based Compensation for additional discussion of the use of estimates in estimating the fair value of the Company’s common stock. 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. Cash and cash equivalents that are restricted as to withdrawal or use under the terms of certain executed agreements are recorded as restricted cash on the balance sheets. As of December 31, 2021, the Company had restricted cash in the amount of $7,875,000, which consisted of cash held in a money market account pledged as collateral for a note payable to Silicon Valley Bank, or the SVB Loan. The restricted cash was used in the repayment of the SVB Loan in November 2022. See Note 7 – Notes Payable and Convertible Notes Payable – Silicon Valley Bank Loan. As of December 31, 2022 and 2021, the Company had cash and cash equivalent balances in excess of FDIC insurance limits of $22,613,520 and $19,211,850, 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 a deposit account 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 $194,000 in a deposit account at SVB. Property and Equipment, Net Property and equipment are stated at cost, net of accumulated depreciation, which is recorded commencing at the in-service date using the straight-line method at rates sufficient to charge the cost of depreciable assets to operations over their estimated useful lives, which range from 1 to 10 years. Leasehold improvements are amortized over the lesser of (a) the useful life of the asset; or (b) the remaining lease term. Maintenance and repairs are charged to operations as incurred. The Company capitalizes costs attributable to the betterment of property and equipment when such betterment extends the useful life of the assets. Impairment of Long-lived Assets The Company reviews for the impairment of long-lived assets whenever events or changes in circumstances indicate that the carrying amount of an asset might not be recoverable. An impairment would be recognized when estimated future cash flows expected to result from the use of the asset and its eventual disposition are less than its carrying amount. The Company did not record any impairment losses during the years ended December 31, 2022 and 2021. Fair Value of Financial Instruments The Company measures the fair value of financial assets and liabilities based on Accounting Standards Codification, or ASC Topic 820 “Fair Value Measurements and Disclosures”, or ASC 820, which defines fair value, establishes a framework for measuring fair value, and expands disclosures about fair value measurements. ASC 820 defines fair value 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. ASC 820 also establishes a fair value hierarchy, which requires an entity to maximize the use of observable inputs and minimize the use of unobservable inputs when measuring fair value. ASC 820 describes three levels of inputs that may be used to measure fair value: Level 1 — quoted prices in active markets for identical assets or liabilities; Level 2 — quoted prices for similar assets and liabilities in active markets or inputs that are observable; and Level 3 — inputs that are unobservable (for example, cash flow modeling inputs based on assumptions). The carrying amounts of the Company’s financial instruments, such as cash and cash equivalents, restricted cash, accounts payable, and notes payable approximate fair values due to the short-term nature or effective interest rates of these instruments. Income Taxes The Company is subject to Federal, New York State and City, and State of California income taxes and files tax returns in those jurisdictions. The Company recognizes deferred tax assets and liabilities for the expected future tax consequences of items that have been included or excluded in the financial statements or tax returns. Deferred tax assets and liabilities are determined on the basis of the difference between the tax basis of assets and liabilities and their respective financial reporting amounts, or temporary differences, at enacted tax rates in effect for the years in which such temporary differences are expected to reverse. The Company utilizes a recognition threshold and measurement process for financial statement recognition and measurement of a tax position taken or expected to be taken in a tax return. The Company’s policy is to classify assessments, if any, for tax-related interest as interest expense and penalties as general and administrative expenses in the statements of operations. Revenue Recognition The Company’s revenues are generated primarily through research, development and commercialization agreements. The terms of such agreements may contain multiple promised goods and services, which may include (i) licenses to its intellectual property, and (ii) in certain cases, payment in connection with the manufacturing and delivery of clinical supply materials. Payments to us under these arrangements typically include one or more of the following: non-refundable, upfront license fees; milestone payments; payments for clinical product supply, and royalties on future product sales. The Company analyzes its arrangements to assess whether such arrangements involve joint operating activities. For collaboration arrangements that are deemed to be within the scope of ASC Topic 808, “Collaborative Arrangements”, or ASC 808, the Company allocates the contract consideration between such joint operating activities and elements that are reflective of a vendor-customer relationship and, therefore, within the scope of ASC Topic 606, “Revenue from Contracts with Customers”, or ASC 606. The Company’s policy is to recognize amounts allocated to joint operating activities as a reduction in research and development expense. Under ASC 606, the Company recognizes revenue when its customers obtain control of promised goods or services, in an amount that reflects the consideration the Company expects to receive in exchange for those goods or services. To determine revenue recognition for arrangements that the Company determines are within the scope of ASC 606, the Company performs the following five steps: ● Step 1: Identify the contract with the customer; ● Step 2: Identify the performance obligations in the contract; ● Step 3: Determine the transaction price; ● Step 4: Allocate the transaction price to the performance obligations in the contract; and ● Step 5: Recognize revenue when the company satisfies a performance obligation. The Company must make significant judgments in its revenue recognition process, including identifying performance obligations in the contract, estimating the amount of variable consideration to include in the transaction price and allocating the transaction price to each performance obligation. Milestone payments represent variable consideration that will be recognized when the performance obligation is achieved. Sales-based royalty payments derived from usage of intellectual property are recognized when those sales occur. Arrangements that include rights to additional goods or services that are exercisable at a customer’s discretion are generally considered discretionary purchase options. The Company assesses if these options provide a material right to the customer and if so, they are considered performance obligations. During 2020, the Company entered into a license agreement, or the Arctic Vision License Agreement, with Arctic Vision (Hong Kong) Limited, or Arctic Vision, and a license agreement, or the Bausch License Agreement, with Bausch Health Companies, Inc., or Bausch + Lomb. Each license has three revenue components: 1) an upfront license fee; 2) milestone payments and 3) royalty payments. Arctic Vision License Agreement On August 10, 2020, the Company entered into the Arctic Vision License Agreement pursuant to which Arctic Vision may develop and commercialize MicroPine for the treatment of progressive myopia and MicroLine for the treatment of presbyopia in Greater China (mainland China, Hong Kong, Macau and Taiwan) and South Korea. On September 14, 2021, the Company and Arctic Vision executed Amendment 1 to the Arctic Vision License Agreement, or Arctic Vision Amendment 1, pursuant to which Arctic Vision may develop and commercialize MicroStat for the treatment of mydriasis in Greater China and South Korea. Upfront License Fees During the year ended December 31, 2021, the Company recognized $4.0 million in revenue, pursuant to the Arctic Vision license agreement, upon the submission of certain trial data to Arctic Vision, permitting Arctic Vision to seek regulatory approval with the National Medical Products Administration of China. Pursuant to the terms of the Senju License Agreement (see Note 10 – Related Party Transactions) the Company is required to pay Senju a percentage of payments received from Arctic Vision. Accordingly, the Company paid $1.6 million to Senju in connection with the $4.0 million upfront license fees received from Arctic Vision, which is reflected as cost of revenue in the accompanying statements of operations. In connection with Arctic Vision Amendment 1, Arctic Vision paid the Company a $250,000 upfront fee, which in turn, the Company paid to Senju in connection with Senju Amendment 2 (see Note 10 – Related Party Transactions). The Company did not recognize revenue for the $250,000 upfront payment because it was passed through to Senju. Milestone Payments The Company may receive an additional $37.7 million in milestone payments in connection with the Arctic Vision License Agreement, as amended, based on various development and regulatory milestones, including the initiation of clinical research and regulatory approvals in Greater China and South Korea, related to the filing of Marketing Authorization Applications of approximately $13.2 million and the receipt of regulatory approvals of approximately $24.5 million. The Company currently anticipates the remaining milestone related performance obligations to be achieved between late 2024 and late 2025. Royalty Payments Arctic Vision also will purchase its supply of MicroPine, MicroLine and MicroStat from the Company or, for such products not supplied by the Company, pay the Company a mid-single digit percentage royalty on net sales of such products, subject to certain adjustments. No royalty payments were earned through December 31, 2022. The Company will pay a percentage in the range from 30% to 40% of such payments, royalties, or net proceeds of such supply to Senju pursuant to the Senju License Agreement. See Note 10—Related Party Transactions—Senju License Agreement for additional details. Bausch License Agreement On October 9, 2020, the Company entered into the Bausch License Agreement pursuant to which Bausch + Lomb may develop and commercialize the Bausch Licensed Product in the Licensed Territory. Bausch + Lomb may terminate the Bausch License Agreement, with respect to the Bausch Licensed Product to either country in the Licensed Territory, at any time for convenience upon 90 days ’ written notice. Both parties have the right to terminate the Bausch License Agreement in the event of (i) an uncured material breach after a 60-day period or (ii) a bankruptcy event. Upfront License Fees During the year ended December 31, 2021, the Company recognized revenue of $10.0 million upon the submission of certain trial to Bausch + Lomb and the transfer of supervisory oversight of the clinical trial to Bausch + Lomb, permitting Bausch + Lomb to assume supervisory oversight of the ongoing MicroPine study, or the CHAPERONE study. Milestone Payments Bausch + Lomb could also pay the Company up to an aggregate of approximately $35.0 million in additional payments, depending on the achievement of certain regulatory and launch-based milestones. No milestone payments were earned through December 31, 2022. The Company currently anticipates that the aforementioned milestone payments will be earned between late 2024 and late 2025. Royalty Payments Under the terms of the Bausch License Agreement, on a country-to-country basis and Bausch Licensed Product-by- Bausch Licensed Product basis, Bausch + Lomb will pay the Company royalties on a tiered basis (ranging from mid-single digit to mid-teen percentages) on gross profits from the sales of the Bausch Licensed Product in the Licensed Territory, subject to certain adjustments in the event of generic entry, negative gross profits or patent expiration, for a period of the later to occur of the 10th anniversary of the first commercial sale of a Bausch Licensed Product in such country in the Licensed Territory or the expiration of the last valid patent claim for a Bausch Licensed Product in such country in the Licensed Territory. No royalty payments were earned through December 31, 2022. Clinical Supply Arrangements Bausch + Lomb and 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. Our licensing agreements with Bausch + Lomb 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. Deferred clinical supply costs were $2.3 million at December 31, 2022. Net income from the sale of clinical supplies was included in other income and amounted to $0.2 million for the year ended December 31, 2022. Operating Leases The Company adopted the Accounting Standards Update, or ASU 2016-02,“Leases (Topic 842)” as of December 31, 2022, effective January 1, 2022. The Company leases its facilities under non-cancellable operating leases. The Company evaluates the nature of each lease at the inception of an arrangement to determine whether it is an operating or financing lease and recognizes the ROU asset and lease liabilities based on the present value of future minimum lease payments over the expected lease term. The Company recognizes a liability to make lease payments, the “lease liability”, and an asset representing the right to use the underlying asset during the lease term, the “right-of-use asset”. The lease liability is measured at the present value of the remaining lease payments, discounted at the Company's incremental borrowing rate. The Company’s leases do not generally contain an implicit interest rate and therefore the Company uses the incremental borrowing rate it would expect to pay to borrow on a similar collateralized basis over a similar term in order to determine the present value of its lease payments. The right-of-use asset is measured at the amount of the lease liability adjusted for the remaining balance of any lease incentives received, any cumulative prepaid or accrued rent if the lease payments are uneven throughout the lease term, any unamortized initial direct costs, and any impairment of the right-of-use-asset. Operating lease expense consists of a single lease cost calculated so that the remaining cost of the lease is allocated over the remaining lease term on a straight-line basis, variable lease payments not included in the lease liability, and any impairment of the right-of-use asset. Research and Development Research and development expenses are charged to operations as incurred. The Company records prepaid expenses on its balance sheet for the payment of research and development expenses in advance of services being provided. The Company’s license agreements were determined to represent collaborative arrangements. Pursuant to these collaborative arrangements, the licensee is required to reimburse the Company for certain research and development expenses. Providing research and development activities in the context of a collaboration agreement is not an ordinary activity for the Company. Accordingly, the licensee is not a customer with respect to the reimbursements and such payments are not subject to ASC 606 – Revenue Recognition. The Company’s policy is to recognize the reimbursements as contra – research and development expense. The receivable for such payments, plus other license payments, is included in “license fee and expense reimbursements receivable” on the accompanying balance sheets. Stock-Based Compensation The Company measures the cost of services received in exchange for an award of equity instruments based on the fair value of the award. The fair value of the award is measured on the grant date and the fair value amount is then recognized over the period during which services are required to be provided in exchange for the award, usually the vesting period. Upon the exercise of an option, the Company issues new shares of common stock out of the shares reserved for issuance under its equity plans. Net Loss Per Share of Common Stock Basic net loss per share of common stock is computed by dividing net loss by the weighted average number of shares of common stock outstanding during the period. Diluted loss 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 Years Ended December 31, 2022 2021 Numerator: Net income (loss) $ (28,011,157) $ (12,778,387) Net loss attributable to common stockholders $ (28,011,157) $ (12,778,387) Denominator (weighted average quantities): Common shares issued 33,252,644 26,238,134 Add: Prefunded warrants 333,037 — Add: Undelivered vested restricted shares 64,066 85,947 Denominator for basic and diluted net loss per share 33,649,747 26,324,081 Basic and diluted net loss per share of common stock $ (0.83) $ (0.49) The following securities are excluded from the calculation of weighted average dilutive shares of common stock because their inclusion would have been anti-dilutive: December 31, 2022 2021 Warrants 6,087,845 1,217,715 Options 5,380,553 4,377,398 Restricted stock units 172,800 41,778 Total potentially dilutive shares 11,641,198 5,636,891 Subsequent Events The Company has evaluated subsequent events through the date which the financial statements were issued. Based upon the evaluation, the Company did not identify any recognized or non-recognized subsequent events that would have required adjustment or disclosure in the financial statements, except as disclosed. Recently Adopted Accounting Standards On May 3, 2021, the Financial Accounting Standards Board, or the FASB, issued ASU No. 2021-04, “Earnings Per Share (Topic 260), Debt—Modifications and Extinguishments (Subtopic 470-50), Compensation—Stock Compensation (Topic 718), and Derivatives and Hedging—Contracts in Entity’s Own Equity (Subtopic 815-40): Issuer’s Accounting for Certain Modifications or Exchanges of Freestanding Equity-Classified Written Call Options.” This new standard provides clarification and reduces diversity in an issuer’s accounting for modifications or exchanges of freestanding equity-classified written call options (such as warrants) that remain equity classified after modification or exchange. This standard is effective for fiscal years beginning after December 15, 2021, including interim periods within those fiscal years. Issuers should apply the new standard prospectively to modifications or exchanges occurring after the effective date of the new standard. The Company adopted ASU 2021-04 effective January 1, 2022. This standard did not have a material impact on the Company’s financial position, results of operations or cash flow. In February 2016, the FASB issued ASU 2016-02 “Leases (Topic 842)”, or ASU 2016-02. ASU 2016-02 requires that a lessee recognize the assets and liabilities that arise from operating leases. A lessee should recognize in the statement of financial position a liability to make lease payments (the lease liability) and a right-of-use asset representing its right to use the underlying asset for the lease term. ASU 2016-02, as amended, is now effective for emerging growth companies for fiscal years beginning after December 15, 2021, and interim periods within fiscal years beginning after December 15, 2022. The Company adopted ASU 2016-02 on December 31, 2022, effective January 1, 2022 and the adoption of this ASU had a material impact on the Company’s financial statements, primarily as a result of recording right-of-use assets and lease liabilities for its operating leases in the approximate amounts of $580,000 and $619,000, and derecognizing deferred rent in the approximate amount of $39,000. Recently Issued 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 will be required to adopt the provisions of this ASU on January 1, 2023, with early adoption permitted for certain amendments. Topic 326 must be adopted by applying a cumulative effect adjustment to retained earnings. The adoption of Topic 326 is not expected to 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, this ASU improves disclosure requirements for convertible instruments and earnings-per-share guidance. The ASU 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, but not earlier than for fiscal years beginning after December 15, 2020. 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 is not expected to 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 | 12 Months Ended |
Dec. 31, 2022 | |
Prepaid Expenses and Other Current Assets | |
Prepaid Expenses and Other Current Assets | Note 3 – Prepaid Expenses and Other Current Assets As of December 31, 2022 and 2021, prepaid expenses and other current assets consisted of the following: December 31, 2022 2021 Payroll tax receivable $ 660,891 $ 343,785 Prepaid insurance expenses 201,082 171,370 Prepaid conference expenses 97,743 12,586 Prepaid general and administrative expenses 87,982 71,375 Prepaid rent and security deposit 74,959 32,254 Prepaid patent expenses 38,796 32,797 Other 26,745 4,525 Prepaid research and development expenses 2,521 — Prepaid board of directors fees — 66,250 Total prepaid expenses and other current assets $ 1,190,719 $ 734,942 |
Property and Equipment, Net
Property and Equipment, Net | 12 Months Ended |
Dec. 31, 2022 | |
Property and Equipment, Net | |
Property and Equipment, Net | Note 4 - Property and Equipment, Net As of December 31, 2022 and 2021, property and equipment consisted of the following: December 31, 2022 2021 Equipment $ 1,271,372 $ 854,060 Equipment not yet placed in service 90,411 254,864 Leasehold improvements 569,170 490,709 1,930,953 1,599,633 Less: accumulated depreciation and amortization (635,838) (328,408) Property and equipment, net $ 1,295,115 $ 1,271,225 Depreciation expense was $307,430 and $221,563 for the years ended December 31, 2022 and 2021, respectively, of which $301,205 and $211,604, respectively, was included within research and development expenses and $6,225 and $9,959, respectively, was included in general and administrative expenses in the accompanying statements of operations. As of December 31, 2022 and 2021, the Company had $726,326 and $391,941 of outstanding deposits for equipment purchases. |
Accrued Expenses and Other Curr
Accrued Expenses and Other Current Liabilities | 12 Months Ended |
Dec. 31, 2022 | |
Accrued Expenses and Other Current Liabilities | |
Accrued Expenses and Other Current Liabilities | Note 5 – Accrued Expenses and Other Current Liabilities As of December 31, 2022 and 2021, accrued expenses and other current liabilities consisted of the following: December 31, 2022 2021 Accrued consulting and professional services $ 320,000 $ 250,000 Accrued leasehold improvements 92,528 — Credit card payable 50,639 20,000 Accrued research and development expenses 35,524 436,840 Other 4,385 42,407 Accrued interest — 94,792 Accrued franchise tax — 1,680 Total accrued expenses and other current liabilities $ 503,076 $ 845,719 |
Accrued Compensation
Accrued Compensation | 12 Months Ended |
Dec. 31, 2022 | |
Accrued Compensation | |
Accrued Compensation | Note 6 – Accrued Compensation As of December 31, 2022 and 2021, accrued compensation consisted of the following: December 31, 2022 2021 Accrued bonus expenses $ 1,447,643 $ 1,245,795 Accrued payroll expenses 299,548 297,823 Total accrued compensation $ 1,747,191 $ 1,543,618 |
Notes Payable and Convertible N
Notes Payable and Convertible Notes Payable | 12 Months Ended |
Dec. 31, 2022 | |
Notes Payable and Convertible Notes Payable | |
Notes Payable and Convertible Notes Payable | Note 7 – Notes Payable and Convertible Notes Payable As of December 31, 2022 and 2021, notes payable and convertible notes payable consisted of the following: December 31, 2022 December 31, 2021 Notes Payable Debt Discount Net Notes Payable Debt Discount Net Silicon Valley Bank loan $ — $ — $ — $ 7,500,000 $ (349,632) $ 7,150,368 Avenue - Note payable 5,212,500 (847,114) 4,365,386 — — — Avenue - Convertible note payable 5,212,500 (847,114) 4,365,386 — — — Total 10,425,000 (1,694,228) 8,730,772 7,500,000 (349,632) 7,150,368 Less: Current portion Silicon Valley Bank loan — — — (7,500,000) 349,632 $ (7,150,368) Avenue - Note payable (208,333) 33,885 (174,448) — — — Avenue - Convertible note payable (208,333) 33,885 (174,448) — — — Notes Payable, Non-Current $ 10,008,334 $ (1,626,458) $ 8,381,876 $ — $ — $ — The non-current portion of notes payable and convertible notes payable includes a notes payable and a convertible note payable, each in the amount, net of discount, of $4,190,938. BankDirect Capital Finance Loan On February 24, 2021, the Company issued a note payable for the purchase of a directors and officers’ liability insurance policy. The note payable was payable in nine monthly On February 24, 2022, the Company issued a note payable for the purchase of a directors and officers’ liability insurance policy. The note payable was payable in six monthly Paycheck Protection Program Loan On May 8, 2020, the Company received cash proceeds of $463,353 pursuant to a loan provided in connection with the Paycheck Protection Program under the CARES Act, or the PPP Loan. The PPP Loan provided for monthly installment payments of $19,508 beginning in August 2021 with the remaining balance due on May 3, 2022, the original maturity date. The PPP Loan incurred interest at a fixed rate of 1.00% per annum. Under the terms of the CARES Act, as amended by the Paycheck Protection Program Flexibility Act of 2020, the Company was eligible to apply for and receive forgiveness for all or a portion of its PPP Loan. The Company applied for loan forgiveness on the PPP Loan in March 2021. The Company received notification in August 2021 that it had received approval for full loan forgiveness of the PPP Loan in the amount of $463,353. The Company has recorded this extinguishment as other income in the statements of operations for the year ended December 31, 2021. The Company also received notification of forgiveness of accrued interest payable of $5,738, which was reversed from interest expense. Silicon Valley Bank Loan On May 7, 2021, or the Effective Date, the Company entered into a Loan and Security Agreement, or the Loan, with Silicon Valley Bank, or SVB, for an aggregate principal amount of up to $25.0 million. The interest rate on the Loan was an annual rate equal to the greater of (a) the sum of 1.25% plus the prime rate as reported in The Wall Street Journal and (b) 5.00%. The initial tranche of the Loan, in the amount of $7.5 million was received by the Company on May 7, 2021. The maturity date of the Loan was May 1, 2025. The Loan indicated a prepayment fee of 2.0% of the principal balance made on or prior to the second anniversary of the Effective Date. The Loan also provided for a final payment in an amount equal to the original aggregate principal amount of the Loan multiplied by 5.0%. The final payment is in addition to and not a substitution for the regular monthly payments of principal plus accrued interest and was due upon the repayment of the loan in full. On September 29, 2021, the Company and SVB executed the First Amendment to the Loan and Security Agreement, or the Amendment. In accordance with the Amendment, the Company was required to maintain a collateralized money market account in the amount of $7,875,000. The Company recorded this amount as restricted cash. On October 25, 2021, the Company announced the reclassification of Mydcombi as a drug-device combination product by the FDA in a CRL received on October 22, 2021. Given the FDA’s recent reclassification of Mydcombi as a drug-device combination and the need to file an NDA resubmission in 2022, the restricted cash became callable on November 30, 2021, at SVB’s election, to satisfy the Loan obligations. Therefore, the Loan was fully classified as a current note payable as of December 31, 2021. In connection with the Loan, the Company issued warrants to SVB to purchase 91,884 shares of common stock at an exercise price per share equal to $4.76. The warrants are exercisable for a period of ten years from the date of issuance. The Company determined that the warrants should be equity-classified and that the relative fair value was $354,539, by using the Black-Scholes option pricing methodology using the following assumptions: stock price of $4.76; expected term of 10.0 years; volatility of 89.0% and a risk-free interest rate of 1.60%. The Company incurred $66,618 of debt issuance costs, of which $63,469 was allocated to the debt and $3,149 was allocated to the warrants. The relative fair value of the warrants and the issuance costs allocated to the debt were recorded as debt discount. On November 4, 2022, the Company repaid the SVB Loan in full. The full amount of the payment was $8,025,000, and included the principal amount of the loan ($7,500,000), the final payment ($375,000) and a 2% prepayment fee ($150,000). The final payment and prepayment fee were recorded as interest expense. The entire restricted cash account in the amount of $7,875,000 was used to make the substantial amount of the payment. During the years ended December 31, 2022 and 2021, the Company recorded interest expense relating to the Loan of $1,174,736 and $317,333, respectively, including the amortization of debt discount of $349,632 and $68,376, respectively. Avenue Ventures Loan On November 22, 2022, the Company entered into a Loan and Security Agreement, or the Avenue Loan, with Avenue Venture Opportunities Fund, L.P., or Avenue 1, and Avenue Venture Opportunities Fund, L.P. II, or Avenue 2, and together with Avenue, the Lender, for an aggregate principal amount of up to $15,000,000. The initial tranche of the Avenue Loan is $10,000,000, consisting of $4,000,000 from Avenue and $6,000,000 from Avenue 2. Up to $5,000,000 of the principal amount outstanding may be converted at the option of the Lender into shares of the Company’s common stock at a conversion price of $2.148 per share, subject to typical anti-dilution adjustments, or the Convertible Loan. The Avenue Loan bears interest at an annual rate equal to the greater of (A) 7.0% and (B) the prime rate as reported in The Wall Street Journal plus 4.45%. The Avenue Loan maturity date is November 1, 2025. The Company may request an additional $5,000,000 of gross funding between April 1, 2023 and July 31, 2023, subject to agreed-upon conditions. The Company must also make an incremental final payment equal to 4.25% of the aggregate funding, or the Final Payment, amounting to a premium of $425,000. The Company will make monthly interest-only payments during the first twelve months of the Avenue Loan, which could be increased to up to eighteen months upon the achievement of specified performance milestones. Following the interest-only period, the Company will make equal monthly payments of principal and interest until the maturity date, plus interest. If the Company prepays the Avenue Loan, it will be required to pay a prepayment fee of 3% if the Avenue Loan is prepaid during the first year, 2% if the Avenue Loan is prepaid during the second year and 1% if the Avenue Loan is repaid during the third year. The Avenue Loan requires the Company to make and maintain representations and warranties and other agreements that are customary in loan agreements of this type. The Avenue Loan is secured by all of the Company’s assets globally, including intellectual property. The Avenue Loan also contains customary events of default, including non-payment of principal or interest, violations of covenants, bankruptcy and material judgments. Upon the occurrence of an event of default, all interest and principal will be accelerated and immediately become due and payable. In addition, Avenue will have the right to exercise any other right or remedy provided by applicable law. The Company paid a portfolio management fee of 1% of the total commitment of $15,000,000, or $150,000 of cash on December 1, 2022. This has been accounted for as a component of debt discount. In connection with the Loan, the Company granted an aggregate of 547,807 shares of its common stock to the Lender, or the Avenue Private Placement Shares. Based on the Company’s stock price of $1.79 per share on the closing date, the shares have a gross value of $980,575 and a relative fair value of $859,734. This is accounted for as a component of debt discount. The following is a breakdown of the allocation of debt discount and origination costs: Allocation of Debt Discount Withheld Eyenovia Premium- Equity From Origination (Final Equity Total Debt Issuance Allocation % Proceeds Costs Payment) Issued Discount Costs Non-Convertible Note 45.70 % $ 127,916 $ 107,976 $ 212,500 $ 429,867 $ 878,258 $ — Convertible Note 45.70 % 127,916 107,976 212,500 429,867 878,258 — Private Placement Shares 8.60 % 24,063 20,312 — — — 44,376 Total 100.00 % $ 279,895 $ 236,264 $ 425,000 $ 859,734 $ 1,756,516 $ 44,376 Withheld From Closing Proceeds: Broker Fee $ 250,000 Legal Reimbursement 29,895 Total $ 279,895 Eyenovia Origination Costs: Legal Fee $ 86,264 Avenue Management Fee 150,000 Total $ 236,264 Total debt discount of $1,756,516 less the current year amortization of the Avenue loan in the amount of $62,288 resulted in unamortized debt discount of $1,694,228 at December 31, 2022. The following is a summary of the Avenue loan: December 31, 2022 Non-Convertible Convertible Total Initial loan funding $ 5,000,000 $ 5,000,000 $ 10,000,000 Final payment 212,500 212,500 425,000 5,212,500 5,212,500 10,425,000 Less: Unamortized debt discount (847,114) (847,114) (1,694,228) 4,365,386 4,365,386 8,730,772 Less: Current portion (174,448) (174,448) (348,896) Notes Payable, Non-Current $ 4,190,938 $ 4,190,938 $ 8,381,876 During the year ended December 31, 2022, the Company recorded interest expense relating to the Loan of $189,510, including the amortization of debt discount of $62,288. |
Income Taxes
Income Taxes | 12 Months Ended |
Dec. 31, 2022 | |
Income Taxes | |
Income Taxes | Note 8 – Income Taxes The provision for income taxes consists of the following expenses (benefits): For The Years Ended December 31, 2022 2021 Deferred tax provision (benefit): Federal 5,879,362 (1,248,043) State and local (208,806) (2,358,623) 5,670,556 (3,606,666) Change in valuation allowance (5,670,556) 3,606,666 Provision for income taxes $ — $ — The provision for income taxes differs from the United States Federal statutory rate as follows: For The Years Ended December 31, 2022 2021 Federal statutory rate (21.0) % (21.0) % State tax rate, net of federal benefit (2.5) % (7.3) % Permanent differences 1.6 % 4.3 % Research & development tax credits (1.0) % (0.6) % Prior period adjustments and other 1.3 % 0.2 % Rate and apportionment changes 1.3 % (3.8) % Change in valuation allowance 20.3 % 28.2 % Effective income tax rate (0.0) % (0.0) % Deferred tax assets consist of the following: For The Years Ended December 31, 2022 2021 Deferred tax assets: Net operating loss carryforwards $ 20,165,693 $ 17,415,488 Research and development tax credits 799,182 605,919 Capitalized research and development costs 2,304,110 — Stock-based compensation 2,089,014 2,070,759 Intangible assets 633,151 531,454 Lease liability 327,276 — Total gross deferred tax assets 26,318,426 20,623,620 Deferred tax liabilities Property and equipment (184,138) (463,442) Right ot use asset (303,554) — Deferred tax assets, net before allowance 25,830,734 20,160,178 Valuation allowance (25,830,734) (20,160,178) Deferred tax assets, net $ — $ — Changes in valuation allowance $ (5,670,556) $ 3,606,666 As of December 31, 2022, the Company had approximately $85,900,000 of domestic federal net operating loss carryforwards, or NOLs, that may be available to offset future federal taxable income. Approximately $10,800,000 of those NOLs will expire during the years ranging from 2034 to 2037. The remaining NOLs of approximately $75,100,000 have no expiration dates. Internal Revenue Code Section 382 limits the utilization of approximately $35,000,000 of those NOLs to approximately $918,000 on an annual basis as a result of ownership changes that occurred through July 15, 2019. As of December 31, 2022, the Company had approximately $25,400,000 of state NOLs, of which approximately $25,300,000 will expire during the years ranging from 2040 to 2042, and approximately $100,000 will not expire, and had approximately $6,400,000 of local NOLs which do not expire. The Company has assessed the likelihood that deferred tax assets will be realized in accordance with the provisions of ASC 740 “Income Taxes Accounting”, or ASC 740. ASC 740 requires that a valuation allowance be established when it is “more likely than not” that all, or a portion of, deferred tax assets will not be realized. The assessment considers all available positive or negative evidence, including the scheduled reversal of deferred tax liabilities, projected future taxable income, and tax planning strategies. After the performance of such reviews as of December 31, 2022 and 2021, management believes that uncertainty exists with respect to future realization of its deferred tax assets and has, therefore, established a full valuation allowance as of those dates. Management has evaluated and concluded that there were no material uncertain tax positions requiring recognition in the Company’s financial statements as of December 31, 2022 and 2021. The Company does not expect any significant changes in its unrecognized tax benefits within twelve months of the reporting date. No tax audits were commenced or were in process during the years ended December 31, 2022 and 2021. No tax related interest or penalties were incurred during the years ended December 31, 2022 and 2021. The Company’s federal, state and local income tax returns beginning with the year ended December 31, 2019 remain subject to examination. |
Commitments and Contingencies
Commitments and Contingencies | 12 Months Ended |
Dec. 31, 2022 | |
Commitments and Contingencies | |
Commitments and Contingencies | Note 9 – Commitments and Contingencies Employment Agreements On February 14, 2022, the Compensation Committee of the Board approved amendments to the Executive Employment Agreements, or the Employment Agreement Addendums, for three executive officers. Each of the Employment Agreement Addendums provides that if the executive’s employment is terminated by the Company without “Cause” or the executive suffers an “Involuntarily Termination” (each as defined in the employment agreements), provided that the executive has signed a full release of all claims, the executive will be entitled to receive: (i) severance pay equal to twelve months of his or her then-current base salary, and (ii) a reimbursement for health insurance benefits under COBRA for the executive and his or her spouse and dependents for a period of twelve months or until the executive becomes eligible for comparable insurance benefits from another employer, whichever is earlier. Transition of Chief Executive Officer On July 27, 2022, the Company announced the appointment of Michael Rowe as its new Chief Executive Officer, or CEO, effective August 1, 2022, with Dr. Tsontcho Ianchulev (the former CEO) becoming Executive Chairman of the Board. Mr. Rowe is also serving as a member of the Board. On July 26, 2022, the Company entered into an Employment Agreement, or the Employment Agreement, with Mr. Rowe under which he will serve as Chief Executive Officer of the Company. Under the terms of the Employment Agreement, Mr. Rowe will receive an annual salary of $575,000 . He is eligible to receive a cash bonus of up to 60% of his base salary. Additionally, Mr. Rowe received an option to purchase 440,000 shares of the Company’s common stock, exercisable at $1.66 per share, pursuant to the Company’s Amended and Restated 2018 Omnibus Stock Incentive Plan, as amended. Mr. Rowe will also continue to participate in any and all benefit plans, from time to time, in effect for senior management, along with vacation, sick and holiday pay in accordance with the Company’s policies established and in effect from time to time. As a result of the change of salary, the aggregate potential severance pay for the executive officers of the Company is approximately $1,004,000 . The Company also entered into an agreement with Dr. Ianchulev, or the Executive Chairman Agreement, pursuant to which Dr. Ianchulev will provide medical expertise and consultation related to the Company’s research and development programs, and such other matters as reasonably requested by the Company for an initial period of one year . In consideration for Dr. Ianchulev’s services, the Company has agreed to provide Dr. Ianchulev with a $5,000 monthly retainer throughout the term of the agreement, in addition to the compensation payable to all non-employee members of the Board. Operating Leases On August 8, 2018, the Company entered into a lease agreement to lease approximately 3,800 square feet of office space in New York, NY. The monthly base rent ranges from $19,633 to $22,486 per month over the term of the lease. The lease expires on September 30, 2023. The security deposit is approximately $118,000, which has been classified as a current asset. The Company’s rent expense for this space is recorded in general and administrative expense and amounted to $242,067 for each of the years ended December 31, 2022 and 2021, respectively. On January 20, 2020, the Company entered into a lease agreement to lease 660 square feet of office space in Laguna Hills, California. The lease term was one year and the lease was renewed each year until it expired on April 30, 2022. The monthly base rent ranged from $1,254 to $1,292 per month over the term of the lease. The Company received its $1,254 security deposit after the lease expired. The Company had also agreed to lease the adjoining premises as part of the lease extension. The additional office space is also 660 square feet. The lease term for this space expires April 30, 2023. The monthly rent ranges from $1,750 to $1,838 per month. The security deposit is $1,750 and has been classified as a current asset. The Company’s rent expense for the space in this location is recorded in general and administrative expense and amounted to $20,501 and $29,424 for the years ended December 31, 2022 and 2021, respectively. On April 8, 2022, the Company entered into a new lease agreement for 3,916 square feet in Laguna Hills, California. The new lease term is five years and two months, commencing on June 1, 2022 and expiring on July 31, 2027. The monthly base rent ranges from $9,203 to $10,358 per month over the term of the lease. The security deposit is $11,400. The Company’s rent expense for all Laguna Hills space is recorded in general and administrative expense and amounted to $66,196 and $0 for the years ended December 31, 2022 and 2021, respectively. On July 17, 2020, the Company entered into a lease agreement to lease approximately 3,000 square feet of office space in Redwood City, California, or the Gross Industrial Lease. The monthly base rent was for $7,500 per month over the term of the lease through August 31, 2021 with a security deposit of $7,500. On December 1, 2020, the Company agreed to amend the terms of the Gross Industrial Lease for a base rent that ranges from $7,500 to $7,957 per month over the term of the lease. The amended Gross Industrial Lease expires on August 31, 2023. Concurrent with the amendment to the Gross Industrial Lease on December 1, 2020, the Company entered into a lease agreement to lease approximately 1,500 square feet of additional office space in Redwood City, California. The monthly base rent ranges from $3,000 to $3,183 per month over the term of the lease. The lease expires on August 31, 2023. The security deposit is $3,000. Also concurrent with the amendment to the Gross Industrial Lease on December 1, 2020, the Company entered into an additional lease agreement to lease 2,169 square feet of additional office space in Redwood City, California. The monthly base rent ranges from $4,468 to $4,602 per month over the term of the lease. The lease commenced on January 1, 2022 and expires on August 31, 2023. The security deposit is $4,468. The Company's rent expense for all Redwood City space is recorded in research and development expense and amounted to $180,240 and $128,560 for the years ended December 31, 2022 and 2021, respectively. The Company leases 953 square feet of office space in Reno, NV for research and development activities from a company owned by the Company’s former Vice President of Research and Development. The lease, as amended in September 2022, expires on May 1, 2023 and provides for lease payments of $5,675 per month and a security deposit in the amount of $5,675. Since the inception of the lease, the Company made $112,600 of leasehold improvements related to this lease which are included in property and equipment, net on the accompanying balance sheets. The Company’s rent expense for this space is recorded in research and development expense and amounted to $68,498 and $64,848 for the years ended December 31, 2022 and 2021, respectively. On May 19, 2022, the Company entered into a lease agreement to lease 10,880 square feet of office space in Reno, Nevada. The lease term is five years and four months, commencing on May 23, 2022 and expiring on September 23, 2027. The monthly base rent ranges from $13,056 to $16,663 per month over the term of the lease. The security deposit is $53,000. The Company’s rent expense for this space is recorded in research and development expense and amounted to $101,023 for the year ended December 31, 2022. A summary of the Company’s right-of-use assets and liabilities is as follows: For the Year Ended December 31, 2022 Cash paid for amounts included in the measurement of lease liabilities: Operating cash flows used in operating activities $ 412,478 Right-of-use assets obtained in exchange for lease obligations Operating leases $ 1,186,098 Weighted Average Remaining Lease Term (Years) Operating leases 3.71 years Weighted Average Discount Rate Operating leases 10.0 % Future minimum payments under the Company’s operating lease agreements are as follows: For the Year Ending December 31, Minimum Lease Payments 2023 $ 588,181 2024 278,254 2025 289,887 2026 302,039 2027 216,126 Total lease payments 1,674,487 Less: Imputed interest (281,961) Present value of lease liabilities 1,392,526 Less: current portion (484,882) Lease liabilities, non-current portion $ 907,644 Litigations, Claims and Assessments In the normal course of business, 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. |
Related Party Transactions
Related Party Transactions | 12 Months Ended |
Dec. 31, 2022 | |
Related Party Transactions | |
Related Party Transactions | Note 10 – Related Party Transactions See Note 9 - Commitments and Contingencies for certain commitments and contingencies entered into with certain related parties. Senju License Agreement During 2015, the Company entered into an exclusive license agreement with Senju, or the Senju License Agreement, whereby the Company agreed to grant to Senju an exclusive, royalty-bearing license for its microdose product candidates for Asia to sublicense, develop, make, have made, manufacture, use, import, market, sell, and otherwise distribute the microdose product candidates. In consideration for the license, Senju agreed to pay to Eyenovia five percent (5%) royalties on sales (net of certain manufacturing costs) for the term of the Senju License Agreement, subject to certain adjustments upon the loss of patent coverage for the term of the license agreement. The agreement will continue in full force and effect, on a country-by-country basis, until the latest to occur of: (i) the tenth (10th) anniversary of the first commercial sale of such a product candidate in a country; or (ii) the expiration of the licensed patents in a country. As of the date of this filing, there have been no commercial sales of such a product in Asia; therefore, no royalties have been earned. Senju is owned by the family of a former member of the Company’s Board of Directors. On April 8, 2020, Eyenovia entered into an amendment, or the Senju License Amendment, to the Senju License Agreement. Pursuant to the Senju License Amendment, the Company can license to any third party the right to research, develop, commercialize, manufacture or use certain products, or the Senju Licensed Products previously licensed to Senju in China (including the People’s Republic of China, Hong Kong, Macao, and Taiwan) and South Korea, or the Territory. Pursuant to the Senju License Amendment, the Company must pay Senju (a) a percentage in the range of 30% to 40% of revenue on (i) any lump-sum payments the Company receives from the third party, (ii) revenue (net of costs) obtained by the Company from contract research and/or development of the Senju Licensed Product in the Territory, and (iii) revenue (net of costs) obtained by the Company from contract manufacture for the device of the Senju Licensed Product in the Territory, the aggregate of which must be at least a $9 million minimum payment to Senju; and (b) a percentage in the range of 30% to 40% of any sales royalty revenue the Company receives from the third party. Since the Company executed a third-party license prior to the April 8, 2021 expiration of the Senju License, the Senju License Amendment will remain in effect for the duration of the license, subject to early termination. The Senju License Agreement was further amended in a Letter Agreement by and between the Company and Senju on August 10, 2020, or the Letter Agreement. Pursuant to the Letter Agreement, the Company will pay to Senju a percentage in the range of 30% to 40% of certain payments, royalties, or net proceeds received from Arctic Vision in connection with the Arctic Vision License Agreement. The Senju License Agreement was amended further by the License Amendment 2, effective September 14, 2021, or the Amendment 2. The Amendment 2 excludes Greater China and South Korea from the territory in which Senju was granted an exclusive royalty-bearing license from the Company. In consideration for this exclusion, and upon and after the execution of Amendment 1 with Arctic Vision, the Company must make payments to Senju based on non-royalty license revenue and sales revenue, including the following: 1. a one-time upfront payment of $250,000 , paid on September 17, 2021, which represented an inducement to Senju to approve Amendment 1 of the Arctic Vision License Agreement related to the MicroStat product. 2. a percentage in the range from 30% to 40% of any upfront or milestone lump sum payments, or net revenues received by the Company in connection with any licensed product using piezo-print technology in a microdose dispenser containing: (a) the chemical substance atropine sulfate as its sole active ingredient and that is used for the treatment of myopia in humans; (b) the chemical substance pilocarpine as its sole active ingredient and that is used for the treatment of presbyopia in humans; or (c) the chemical substances phenylephrine and tropicamide in combination as active ingredients that are used for pharmaceutical mydriasis in humans (the “LA2 Licensed Product”) from certain third parties, and 3. a percentage in the range from thirty to forty percent of the amounts received by the Company in connection with sales of the LA2 Licensed Product in China and South Korea by certain third parties. See Note 2 – Summary of Significant Accounting Policies – Revenue Recognition - Arctic Vision License Agreement for additional details regarding the Arctic Vision License Agreement. |
Stockholders' Equity
Stockholders' Equity | 12 Months Ended |
Dec. 31, 2022 | |
Stockholders' Equity | |
Stockholders' Equity | Note 11 – Stockholders’ Equity Authorized Capital The Company is authorized to issue 90,000,000 shares of common stock, par value of $0.0001 per share, and 6,000,000 shares of preferred stock, par value of $0.0001 per share. The holders of the Company’s common stock are entitled to one vote per share. The Board of Directors is empowered, without stockholder approval, to issue preferred stock with dividend, liquidation, redemption, voting or other rights. Equity Incentive Plans On April 7, 2020, the Company’s Board of Directors approved the Company’s Amended and Restated 2018 Omnibus Stock Incentive Plan (the “Restated Plan”), which stockholders approved on June 30, 2020. Under the Restated Plan, as amended on June 16, 2022, 5,700,000 shares of the Company’s common stock are reserved for issuance. The Restated Plan requires that all equity awards issued under the Restated Plan vest at least twelve months from the applicable grant date, subject to accelerated vesting, and provides that no dividend or dividend equivalent will be paid on any unvested equity award, although dividends with respect to unvested portions of equity may accrue and be paid when, and if, the awards later vest and the shares are actually issued to the grantee. In addition, the Restated Plan sets an annual limit on the grant date fair value of awards to any non-employee director, together with any cash fees paid during the year, of $150,000, subject to certain exceptions for a non-executive chair of the Board. As of December 31, 2022, the number of securities remaining available for future issuance under equity compensation plans was 1,011,245. At-The-Market Offering May 2021 Sales Agreement On May 14, 2021, the Company entered into a Sales Agreement, or the May 2021 Sales Agreement with SVB Securities LLC, or SVB Securities (formerly known as SVB Leerink LLC), under which the Company was able to offer and sell, from time to time at its sole discretion, shares of its common stock having an aggregate offering price of up to $30 million through SVB Securities as its sales agent. Subject to the terms and conditions of the May 2021 Sales Agreement, SVB Securities was able to sell the common stock by any method permitted by law deemed to be an “at-the-market offering” as defined in Rule 415(a)(4) of the Securities Act of 1933, as amended. SVB Securities was obligated to use commercially reasonable efforts to sell the common stock from time to time, based upon instructions from the Company (including any price, time or size limits or other customary parameters or conditions the Company may impose). The Company had to pay SVB Securities a commission equal to three percent (3.0)% of the gross sales proceeds of any common stock sold through SVB Securities under the May 2021 Sales Agreement. Pursuant to the May 2021 Sales Agreement, the Company commenced sales of its common stock on October 6, 2021. During the year ended December 31, 2021, the Company received approximately $12.8 million in gross proceeds and $12.4 million in net proceeds from the sale of 2,435,604 shares of its common stock under the May 2021 Sales Agreement. December 2021 Sales Agreement On December 14, 2021, the Company entered into a Sales Agreement, or the December 2021 Sales Agreement, with SVB Securities under which the Company may offer and sell, from time to time at its sole discretion, shares of common stock for gross proceeds of up to $50.0 million through SVB Securities as its sales agent, or the Offering. The May 2021 Sales Agreement was terminated upon the effectiveness of the December 2021 Sales Agreement. The issuance and sale of shares, if any, of common stock by the Company under the December 2021 Sales Agreement will be pursuant to the Company’s Registration Statement on Form S-3 (File No. 333-261638) filed with the SEC on December 14, 2021, or the Registration Statement, and the prospectus relating to the Offering filed therewith that forms a part of the Registration Statement. Subject to the terms and conditions of the December 2021 Sales Agreement, SVB Securities may sell the common stock by any method permitted by law deemed to be an “at the market offering” as defined in Rule 415(a)(4) of the Securities Act of 1933, as amended. SVB Securities will use commercially reasonable efforts to sell the common stock from time to time, based upon instructions from the Company (including any price, time or size limits or other customary parameters or conditions the Company may impose). The Company will pay SVB Securities a commission equal to three percent (3.0)% of the gross sales proceeds of any common stock sold through SVB Securities under the December 2021 Sales Agreement, and also has provided SVB Securities with certain indemnification rights. During the year ended December 31, 2022, the Company received approximately $5.4 million in gross proceeds and $5.3 million in net proceeds from the sale of 2,716,061 shares of its common stock under the December 2021 Sales Agreement. Securities Purchase Agreement On March 3, 2022, the Company entered into a securities purchase agreement, or the Purchase Agreement with a certain institutional and accredited investor, or the Purchaser, pursuant to which the Company issued (i) 3,000,000 shares of common stock, (ii) pre-funded warrants, or the Pre-Funded Warrants, to purchase an aggregate of 1,870,130 shares of common stock and (iii) warrants to purchase an aggregate of 4,870,130 shares of common stock, or the Investor Warrants, or the March 2022 Offering. The Company determined that the warrants qualified for equity classification. The offering price for the shares was $3.08 per share and the offering price for the Pre-Funded Warrants was $3.07 per Pre-Funded Warrant, which represents the per share public offering price less $0.01 per share exercise price for each Pre-Funded Warrant. The Investor Warrants will have an exercise price of $3.54 per share and each Investor Warrant will be exercisable for one share of Common Stock. The Investor Warrants will be exercisable beginning six months from the date of issuance and the Pre-Funded Warrants will be exercisable immediately upon issuance. The Pre-Funded Warrants shall terminate when fully exercised and the Investor Warrants will terminate five years from the initial exercisability date. The aggregate gross proceeds to the Company from the March 2022 Offering were approximately $15 million, excluding the proceeds, if any, from the exercise of the Pre-Funded Warrants and the Investor Warrants. No underwriter or placement agent participated in the March 2022 Offering. The Company incurred issuance costs in the amount of $89,031 in connection with the March 2022 offering. The March 2022 Offering was made pursuant to an effective registration statement on Form S-3 (Registration Statement No. 333-261638), as previously filed with and declared effective by the Securities and Exchange Commission and a related prospectus. Warrants A summary of the warrant activity during the year ended December 31, 2022 is presented below: Weighted Weighted Average Average Remaining Aggregate Number of Exercise Life Intrinsic Warrants Price In Years Value Outstanding January 1, 2022 1,217,715 $ 2.69 Granted 6,740,260 2.56 Exercised (1,870,130) 0.01 Outstanding December 31, 2022 6,087,845 $ 3.37 4.3 $ — Exercisable December 31, 2022 6,087,845 $ 3.37 4.3 $ — The following table presents information related to warrants as of December 31, 2022: Warrants Outstanding Warants Exercisable Weighted Outstanding Average Exercisable Exercise Number of Remaining Life Number of Price Warrants In Years Warrants $2.4696 909,451 2.2 909,451 $2.7240 216,380 2.2 216,380 $4.7600 91,884 8.3 91,884 $3.5400 4,870,130 4.7 4,870,130 6,087,845 4.3 6,087,845 During the year ended December 31, 2022, warrants for the purchase of 1,870,130 shares of the Company’s common stock with an exercise price $0.01 per share were exercised for aggregate proceeds of $18,701. Stock-Based Compensation Expense The Company records stock-based compensation expense related to stock options and restricted stock units, or RSUs. For the years ended December 31, 2022 and 2021, the Company recorded stock-based compensation expense of $3,765,364 ($1,809,305 of which was included within research and development expenses and $1,956,059 was included within general and administrative expenses on the statements of operations) and $2,886,102 ($1,612,942 of which was included within research and development expenses and $1,273,160 was included within general and administrative expenses on the statements of operations), respectively. Restricted Stock Units A summary of the restricted stock units activity during the year ended December 31, 2022 is presented below: Number of Exercise RSUs Price RSUs non-vested January 1, 2022 41,778 $ 3.59 Granted 193,304 1.93 Vested (55,319) 3.37 Forfeited (6,963) 3.59 RSUs non-vested December 31, 2022 172,800 $ 1.80 Vested RSUs undelivered December 31, 2022 32,900 $ 3.59 To date, the 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 not to deliver shares underlying the RSUs until the termination of service. Between March 31, 2021 and November 17, 2021 the Company granted members of its Board of Directors an aggregate of 49,964 RSUs under the Restated Plan. Each RSU is subject to settlement into one share of the Company’s common stock. The RSUs vest on the earlier of (i) the one-year anniversary of the date of grant and (ii) June 16, 2022 (the date of the 2022 annual stockholders meeting), subject to the grantee remaining on the Board until then. The RSUs had a grant date fair value of $181,200, which will be recognized over the vesting period. Between February 14, 2022 and August 18, 2022 the Company granted members of its Board of Directors an aggregate of 193,304 RSUs under the Restated Plan. Each RSU is subject to settlement into one share of the Company’s common stock. The RSUs vest on the earlier of (i) the one-year anniversary of the date of grant and (ii) the date of the 2023 annual stockholders meeting, subject to the grantee remaining on the Board until then. The RSUs had a grant date fair value of $373,000, which will be recognized over the vesting period. As of December 31, 2022, there was $149,158 of unrecognized stock-based compensation expense related to RSUs which will be recognized over a weighted average period of 0.5 years. Stock Options A summary of the option activity during the year ended December 31, 2022 is presented below: Weighted Weighted Average Average Remaining Aggregate Number of Exercise Life Intrinsic Options Price In Years Value Outstanding, January 1, 2022 4,377,398 $ 3.89 Granted 1,181,310 2.23 Exercised — — Forfeited (178,155) 3.01 Outstanding, December 31, 2022 5,380,553 $ 3.55 7.2 $ 85,800 Exercisable, December 31, 2022 3,614,195 $ 3.79 6.4 $ 85,800 The following table presents information related to stock options as of December 31, 2022: Options Outstanding Options Exercisable Weighted Outstanding Average Exercisable Exercise Number of Remaining Life Number of Price Options In Years Options $1.00 - $1.99 1,517,952 3.8 754,302 $2.00 - $2.99 1,010,018 7.4 847,485 $3.00 - $3.99 1,202,539 6.8 804,840 $4.00 - $4.99 383,500 8.5 193,623 $5.00 - $5.99 100,805 6.0 83,972 $6.00 - $6.99 1,000,821 7.0 765,055 $7.00+ 164,918 5.3 164,918 5,380,553 6.4 3,614,195 In applying the Black-Scholes option pricing model to stock options granted, the Company used the following approximate assumptions: For the Year Ended December 31, 2022 2021 Expected term (years) 0.58 - 10.00 5.85 - 10.00 Risk free interest rate 0.76% - 3.80% 0.45% - 1.58% Expected volatility 82% - 90% 92% - 94% 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 years ended December 31, 2022 and 2021 was approximately $1.60 and $5.39 per share, respectively. As of December 31, 2022, there was $3,621,440 of unrecognized stock-based compensation expense related to stock options which will be recognized over a weighted average period of 1.5 years. |
Employee Benefit Plans
Employee Benefit Plans | 12 Months Ended |
Dec. 31, 2022 | |
Employee Benefit Plans | |
Employee Benefit Plans | Note 12 – Employee Benefit Plans 401(k) Plan In April 2019, the Company adopted the Eyenovia 401(k) Plan, or 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 2019, the Company’s Board of Directors has 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. For the years ended December 31, 2022 and 2021, the Company recorded expense of $208,006 and $175,352 associated with its matching contributions, respectively. |
Subsequent Events
Subsequent Events | 12 Months Ended |
Dec. 31, 2022 | |
Subsequent Events | |
Subsequent Events | Note 13 – Subsequent Events Stock Option Grants Subsequent to December 31, 2022, the Company issued ten-year stock options to certain employees and consultants to purchase an aggregate of 421,735 shares of common stock of the Company at an exercise price $2.16 per share. The options vest as follows: (i) one-third of the shares vest on the one-year anniversary of the issuance date; and (ii) the remaining two-thirds vest in equal installments beginning 13 months from the issuance date and ending 36 months from the issuance date. The fair value of the options will be recognized over the vesting period. December 2021 Sales Agreement Subsequent to December 31, 2022, the Company received approximately $3.5 million of net proceeds from the sale of 1,299,947 shares of its common stock pursuant to the December 2021 Sales Agreement with SVB Securities. Development Collaboration Agreement With Formosa On February 15, 2023, the Company announced that they had entered into a Development Collaboration Agreement, or the Agreement with Formosa Pharmaceuticals, Inc., or Formosa, a Taiwan-based company. The Agreement combines the Company’s Optejet dispensing technology with Formosa’s unique APNT nanoparticle formulation platform for the potential development of new topical ophthalmic therapeutics that employ the Optejet dispenser. In 2023, the Company will conduct feasibility testing of novel APNT formulations in the Optejet and request a pre-IND meeting with the FDA. Formosa will develop and optimize new APNT formulations for use in Optejet and deliver to the Company for device qualification and validation. Appointment of Chief Operating Officer Effective January 1, 2023, the Company appointed Bren Kern, the Company’s Senior Vice President of Manufacturing and Operations, as the Company’s Chief Operating Officer. The Company entered into an Employment Agreement with Mr. Kern, under which Mr. Kern receives an annual salary of $345,000. He is eligible to receive a cash bonus of up to 30% of his base salary. Additionally, Mr. Kern received an option to purchase 120,000 shares of its common stock. |
Summary of Significant Accoun_2
Summary of Significant Accounting Policies (Policies) | 12 Months Ended |
Dec. 31, 2022 | |
Summary of Significant Accounting Policies | |
Liquidity and Going Concern | Liquidity and Going Concern As of December 31, 2022, the Company had unrestricted cash and cash equivalents of approximately $22.9 million and an accumulated deficit of approximately $118.2 million. For the years ended December 31, 2022 and 2021, the Company incurred net losses of approximately $28.0 million and $12.8 million, respectively, and used cash in operations of approximately $25.1 million and $20.9 million, respectively. The Company does not have recurring revenue and has not yet achieved profitability. The Company expects to continue to incur cash outflows from operations for the near future. 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 generate sufficient recurring revenues or 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 its product and service offerings. If the Company is unable to generate sufficient recurring revenues or secure additional capital, it may be required to curtail its research and development initiatives and take additional measures to reduce costs in order to conserve its cash. |
Use of Estimates | Use of Estimates Preparation of financial statements in conformity with accounting principles generally accepted in the United States of America, or U.S. GAAP, requires management to make estimates, judgments and assumptions that affect the amounts reported in the financial statements and the amounts disclosed in the related notes to the financial statements. The Company bases its estimates and judgments on historical experience and on various other assumptions that it believes are reasonable under the circumstances. The amounts of assets and liabilities reported in the Company’s balance sheets and the amounts of expenses reported for each of the periods presented are affected by estimates and assumptions, which are used for, but not limited to, fair value calculations for equity securities, establishment of valuation allowances for deferred tax assets, revenue recognition, the recoverability and useful lives of long-lived assets, the recovery of deferred costs and the deferral of revenues. Certain of the Company’s estimates could be affected by external conditions, including those unique to the Company and general economic conditions. It is reasonably possible that actual results could differ from those estimates. See Note 2 - Summary of Significant Accounting Policies — Stock-Based Compensation for additional discussion of the use of estimates in estimating the fair value of the Company’s common stock. |
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. Cash and cash equivalents that are restricted as to withdrawal or use under the terms of certain executed agreements are recorded as restricted cash on the balance sheets. As of December 31, 2021, the Company had restricted cash in the amount of $7,875,000, which consisted of cash held in a money market account pledged as collateral for a note payable to Silicon Valley Bank, or the SVB Loan. The restricted cash was used in the repayment of the SVB Loan in November 2022. See Note 7 – Notes Payable and Convertible Notes Payable – Silicon Valley Bank Loan. As of December 31, 2022 and 2021, the Company had cash and cash equivalent balances in excess of FDIC insurance limits of $22,613,520 and $19,211,850, 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 a deposit account 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 $194,000 in a deposit account at SVB. |
Property and Equipment, Net | Property and Equipment, Net Property and equipment are stated at cost, net of accumulated depreciation, which is recorded commencing at the in-service date using the straight-line method at rates sufficient to charge the cost of depreciable assets to operations over their estimated useful lives, which range from 1 to 10 years. Leasehold improvements are amortized over the lesser of (a) the useful life of the asset; or (b) the remaining lease term. Maintenance and repairs are charged to operations as incurred. The Company capitalizes costs attributable to the betterment of property and equipment when such betterment extends the useful life of the assets. |
Impairment of Long-lived Assets | Impairment of Long-lived Assets The Company reviews for the impairment of long-lived assets whenever events or changes in circumstances indicate that the carrying amount of an asset might not be recoverable. An impairment would be recognized when estimated future cash flows expected to result from the use of the asset and its eventual disposition are less than its carrying amount. The Company did not record any impairment losses during the years ended December 31, 2022 and 2021. |
Fair Value of Financial Instruments | Fair Value of Financial Instruments The Company measures the fair value of financial assets and liabilities based on Accounting Standards Codification, or ASC Topic 820 “Fair Value Measurements and Disclosures”, or ASC 820, which defines fair value, establishes a framework for measuring fair value, and expands disclosures about fair value measurements. ASC 820 defines fair value 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. ASC 820 also establishes a fair value hierarchy, which requires an entity to maximize the use of observable inputs and minimize the use of unobservable inputs when measuring fair value. ASC 820 describes three levels of inputs that may be used to measure fair value: Level 1 — quoted prices in active markets for identical assets or liabilities; Level 2 — quoted prices for similar assets and liabilities in active markets or inputs that are observable; and Level 3 — inputs that are unobservable (for example, cash flow modeling inputs based on assumptions). The carrying amounts of the Company’s financial instruments, such as cash and cash equivalents, restricted cash, accounts payable, and notes payable approximate fair values due to the short-term nature or effective interest rates of these instruments. |
Income Taxes | Income Taxes The Company is subject to Federal, New York State and City, and State of California income taxes and files tax returns in those jurisdictions. The Company recognizes deferred tax assets and liabilities for the expected future tax consequences of items that have been included or excluded in the financial statements or tax returns. Deferred tax assets and liabilities are determined on the basis of the difference between the tax basis of assets and liabilities and their respective financial reporting amounts, or temporary differences, at enacted tax rates in effect for the years in which such temporary differences are expected to reverse. The Company utilizes a recognition threshold and measurement process for financial statement recognition and measurement of a tax position taken or expected to be taken in a tax return. The Company’s policy is to classify assessments, if any, for tax-related interest as interest expense and penalties as general and administrative expenses in the statements of operations. |
Revenue Recognition | Revenue Recognition The Company’s revenues are generated primarily through research, development and commercialization agreements. The terms of such agreements may contain multiple promised goods and services, which may include (i) licenses to its intellectual property, and (ii) in certain cases, payment in connection with the manufacturing and delivery of clinical supply materials. Payments to us under these arrangements typically include one or more of the following: non-refundable, upfront license fees; milestone payments; payments for clinical product supply, and royalties on future product sales. The Company analyzes its arrangements to assess whether such arrangements involve joint operating activities. For collaboration arrangements that are deemed to be within the scope of ASC Topic 808, “Collaborative Arrangements”, or ASC 808, the Company allocates the contract consideration between such joint operating activities and elements that are reflective of a vendor-customer relationship and, therefore, within the scope of ASC Topic 606, “Revenue from Contracts with Customers”, or ASC 606. The Company’s policy is to recognize amounts allocated to joint operating activities as a reduction in research and development expense. Under ASC 606, the Company recognizes revenue when its customers obtain control of promised goods or services, in an amount that reflects the consideration the Company expects to receive in exchange for those goods or services. To determine revenue recognition for arrangements that the Company determines are within the scope of ASC 606, the Company performs the following five steps: ● Step 1: Identify the contract with the customer; ● Step 2: Identify the performance obligations in the contract; ● Step 3: Determine the transaction price; ● Step 4: Allocate the transaction price to the performance obligations in the contract; and ● Step 5: Recognize revenue when the company satisfies a performance obligation. The Company must make significant judgments in its revenue recognition process, including identifying performance obligations in the contract, estimating the amount of variable consideration to include in the transaction price and allocating the transaction price to each performance obligation. Milestone payments represent variable consideration that will be recognized when the performance obligation is achieved. Sales-based royalty payments derived from usage of intellectual property are recognized when those sales occur. Arrangements that include rights to additional goods or services that are exercisable at a customer’s discretion are generally considered discretionary purchase options. The Company assesses if these options provide a material right to the customer and if so, they are considered performance obligations. During 2020, the Company entered into a license agreement, or the Arctic Vision License Agreement, with Arctic Vision (Hong Kong) Limited, or Arctic Vision, and a license agreement, or the Bausch License Agreement, with Bausch Health Companies, Inc., or Bausch + Lomb. Each license has three revenue components: 1) an upfront license fee; 2) milestone payments and 3) royalty payments. |
Arctic Vision License Agreement | Arctic Vision License Agreement On August 10, 2020, the Company entered into the Arctic Vision License Agreement pursuant to which Arctic Vision may develop and commercialize MicroPine for the treatment of progressive myopia and MicroLine for the treatment of presbyopia in Greater China (mainland China, Hong Kong, Macau and Taiwan) and South Korea. On September 14, 2021, the Company and Arctic Vision executed Amendment 1 to the Arctic Vision License Agreement, or Arctic Vision Amendment 1, pursuant to which Arctic Vision may develop and commercialize MicroStat for the treatment of mydriasis in Greater China and South Korea. Upfront License Fees During the year ended December 31, 2021, the Company recognized $4.0 million in revenue, pursuant to the Arctic Vision license agreement, upon the submission of certain trial data to Arctic Vision, permitting Arctic Vision to seek regulatory approval with the National Medical Products Administration of China. Pursuant to the terms of the Senju License Agreement (see Note 10 – Related Party Transactions) the Company is required to pay Senju a percentage of payments received from Arctic Vision. Accordingly, the Company paid $1.6 million to Senju in connection with the $4.0 million upfront license fees received from Arctic Vision, which is reflected as cost of revenue in the accompanying statements of operations. In connection with Arctic Vision Amendment 1, Arctic Vision paid the Company a $250,000 upfront fee, which in turn, the Company paid to Senju in connection with Senju Amendment 2 (see Note 10 – Related Party Transactions). The Company did not recognize revenue for the $250,000 upfront payment because it was passed through to Senju. Milestone Payments The Company may receive an additional $37.7 million in milestone payments in connection with the Arctic Vision License Agreement, as amended, based on various development and regulatory milestones, including the initiation of clinical research and regulatory approvals in Greater China and South Korea, related to the filing of Marketing Authorization Applications of approximately $13.2 million and the receipt of regulatory approvals of approximately $24.5 million. The Company currently anticipates the remaining milestone related performance obligations to be achieved between late 2024 and late 2025. Royalty Payments Arctic Vision also will purchase its supply of MicroPine, MicroLine and MicroStat from the Company or, for such products not supplied by the Company, pay the Company a mid-single digit percentage royalty on net sales of such products, subject to certain adjustments. No royalty payments were earned through December 31, 2022. The Company will pay a percentage in the range from 30% to 40% of such payments, royalties, or net proceeds of such supply to Senju pursuant to the Senju License Agreement. See Note 10—Related Party Transactions—Senju License Agreement for additional details. |
Bausch License Agreement | Bausch License Agreement On October 9, 2020, the Company entered into the Bausch License Agreement pursuant to which Bausch + Lomb may develop and commercialize the Bausch Licensed Product in the Licensed Territory. Bausch + Lomb may terminate the Bausch License Agreement, with respect to the Bausch Licensed Product to either country in the Licensed Territory, at any time for convenience upon 90 days ’ written notice. Both parties have the right to terminate the Bausch License Agreement in the event of (i) an uncured material breach after a 60-day period or (ii) a bankruptcy event. Upfront License Fees During the year ended December 31, 2021, the Company recognized revenue of $10.0 million upon the submission of certain trial to Bausch + Lomb and the transfer of supervisory oversight of the clinical trial to Bausch + Lomb, permitting Bausch + Lomb to assume supervisory oversight of the ongoing MicroPine study, or the CHAPERONE study. Milestone Payments Bausch + Lomb could also pay the Company up to an aggregate of approximately $35.0 million in additional payments, depending on the achievement of certain regulatory and launch-based milestones. No milestone payments were earned through December 31, 2022. The Company currently anticipates that the aforementioned milestone payments will be earned between late 2024 and late 2025. Royalty Payments Under the terms of the Bausch License Agreement, on a country-to-country basis and Bausch Licensed Product-by- Bausch Licensed Product basis, Bausch + Lomb will pay the Company royalties on a tiered basis (ranging from mid-single digit to mid-teen percentages) on gross profits from the sales of the Bausch Licensed Product in the Licensed Territory, subject to certain adjustments in the event of generic entry, negative gross profits or patent expiration, for a period of the later to occur of the 10th anniversary of the first commercial sale of a Bausch Licensed Product in such country in the Licensed Territory or the expiration of the last valid patent claim for a Bausch Licensed Product in such country in the Licensed Territory. No royalty payments were earned through December 31, 2022. |
Clinical Supply Arrangements | Clinical Supply Arrangements Bausch + Lomb and 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. Our licensing agreements with Bausch + Lomb 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. Deferred clinical supply costs were $2.3 million at December 31, 2022. Net income from the sale of clinical supplies was included in other income and amounted to $0.2 million for the year ended December 31, 2022. |
Research and Development | Research and Development Research and development expenses are charged to operations as incurred. The Company records prepaid expenses on its balance sheet for the payment of research and development expenses in advance of services being provided. The Company’s license agreements were determined to represent collaborative arrangements. Pursuant to these collaborative arrangements, the licensee is required to reimburse the Company for certain research and development expenses. Providing research and development activities in the context of a collaboration agreement is not an ordinary activity for the Company. Accordingly, the licensee is not a customer with respect to the reimbursements and such payments are not subject to ASC 606 – Revenue Recognition. The Company’s policy is to recognize the reimbursements as contra – research and development expense. The receivable for such payments, plus other license payments, is included in “license fee and expense reimbursements receivable” on the accompanying balance sheets. |
Stock-Based Compensation | Stock-Based Compensation The Company measures the cost of services received in exchange for an award of equity instruments based on the fair value of the award. The fair value of the award is measured on the grant date and the fair value amount is then recognized over the period during which services are required to be provided in exchange for the award, usually the vesting period. Upon the exercise of an option, the Company issues new shares of common stock out of the shares reserved for issuance under its equity plans. |
Subsequent Events | Subsequent Events The Company has evaluated subsequent events through the date which the financial statements were issued. Based upon the evaluation, the Company did not identify any recognized or non-recognized subsequent events that would have required adjustment or disclosure in the financial statements, except as disclosed. |
Recently Adopted Accounting Standards | Recently Adopted Accounting Standards On May 3, 2021, the Financial Accounting Standards Board, or the FASB, issued ASU No. 2021-04, “Earnings Per Share (Topic 260), Debt—Modifications and Extinguishments (Subtopic 470-50), Compensation—Stock Compensation (Topic 718), and Derivatives and Hedging—Contracts in Entity’s Own Equity (Subtopic 815-40): Issuer’s Accounting for Certain Modifications or Exchanges of Freestanding Equity-Classified Written Call Options.” This new standard provides clarification and reduces diversity in an issuer’s accounting for modifications or exchanges of freestanding equity-classified written call options (such as warrants) that remain equity classified after modification or exchange. This standard is effective for fiscal years beginning after December 15, 2021, including interim periods within those fiscal years. Issuers should apply the new standard prospectively to modifications or exchanges occurring after the effective date of the new standard. The Company adopted ASU 2021-04 effective January 1, 2022. This standard did not have a material impact on the Company’s financial position, results of operations or cash flow. In February 2016, the FASB issued ASU 2016-02 “Leases (Topic 842)”, or ASU 2016-02. ASU 2016-02 requires that a lessee recognize the assets and liabilities that arise from operating leases. A lessee should recognize in the statement of financial position a liability to make lease payments (the lease liability) and a right-of-use asset representing its right to use the underlying asset for the lease term. ASU 2016-02, as amended, is now effective for emerging growth companies for fiscal years beginning after December 15, 2021, and interim periods within fiscal years beginning after December 15, 2022. The Company adopted ASU 2016-02 on December 31, 2022, effective January 1, 2022 and the adoption of this ASU had a material impact on the Company’s financial statements, primarily as a result of recording right-of-use assets and lease liabilities for its operating leases in the approximate amounts of $580,000 and $619,000, and derecognizing deferred rent in the approximate amount of $39,000. Recently Issued 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 will be required to adopt the provisions of this ASU on January 1, 2023, with early adoption permitted for certain amendments. Topic 326 must be adopted by applying a cumulative effect adjustment to retained earnings. The adoption of Topic 326 is not expected to 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, this ASU improves disclosure requirements for convertible instruments and earnings-per-share guidance. The ASU 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, but not earlier than for fiscal years beginning after December 15, 2020. 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 is not expected to have a material impact on the Company’s financial position, results of operations or cash flows. |
Net Loss Per Share of Common Stock | Net Loss Per Share of Common Stock Basic net loss per share of common stock is computed by dividing net loss by the weighted average number of shares of common stock outstanding during the period. Diluted loss 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 Years Ended December 31, 2022 2021 Numerator: Net income (loss) $ (28,011,157) $ (12,778,387) Net loss attributable to common stockholders $ (28,011,157) $ (12,778,387) Denominator (weighted average quantities): Common shares issued 33,252,644 26,238,134 Add: Prefunded warrants 333,037 — Add: Undelivered vested restricted shares 64,066 85,947 Denominator for basic and diluted net loss per share 33,649,747 26,324,081 Basic and diluted net loss per share of common stock $ (0.83) $ (0.49) The following securities are excluded from the calculation of weighted average dilutive shares of common stock because their inclusion would have been anti-dilutive: December 31, 2022 2021 Warrants 6,087,845 1,217,715 Options 5,380,553 4,377,398 Restricted stock units 172,800 41,778 Total potentially dilutive shares 11,641,198 5,636,891 |
Operating Leases | Operating Leases The Company adopted the Accounting Standards Update, or ASU 2016-02,“Leases (Topic 842)” as of December 31, 2022, effective January 1, 2022. The Company leases its facilities under non-cancellable operating leases. The Company evaluates the nature of each lease at the inception of an arrangement to determine whether it is an operating or financing lease and recognizes the ROU asset and lease liabilities based on the present value of future minimum lease payments over the expected lease term. The Company recognizes a liability to make lease payments, the “lease liability”, and an asset representing the right to use the underlying asset during the lease term, the “right-of-use asset”. The lease liability is measured at the present value of the remaining lease payments, discounted at the Company's incremental borrowing rate. The Company’s leases do not generally contain an implicit interest rate and therefore the Company uses the incremental borrowing rate it would expect to pay to borrow on a similar collateralized basis over a similar term in order to determine the present value of its lease payments. The right-of-use asset is measured at the amount of the lease liability adjusted for the remaining balance of any lease incentives received, any cumulative prepaid or accrued rent if the lease payments are uneven throughout the lease term, any unamortized initial direct costs, and any impairment of the right-of-use-asset. Operating lease expense consists of a single lease cost calculated so that the remaining cost of the lease is allocated over the remaining lease term on a straight-line basis, variable lease payments not included in the lease liability, and any impairment of the right-of-use asset. |
Summary of Significant Accoun_3
Summary of Significant Accounting Policies (Tables) | 12 Months Ended |
Dec. 31, 2022 | |
Summary of Significant Accounting Policies | |
Schedule of computation of basic and diluted net loss per common share | For the Years Ended December 31, 2022 2021 Numerator: Net income (loss) $ (28,011,157) $ (12,778,387) Net loss attributable to common stockholders $ (28,011,157) $ (12,778,387) Denominator (weighted average quantities): Common shares issued 33,252,644 26,238,134 Add: Prefunded warrants 333,037 — Add: Undelivered vested restricted shares 64,066 85,947 Denominator for basic and diluted net loss per share 33,649,747 26,324,081 Basic and diluted net loss per share of common stock $ (0.83) $ (0.49) |
Schedule of weighted average diluted common shares | December 31, 2022 2021 Warrants 6,087,845 1,217,715 Options 5,380,553 4,377,398 Restricted stock units 172,800 41,778 Total potentially dilutive shares 11,641,198 5,636,891 |
Prepaid Expenses and Other Cu_2
Prepaid Expenses and Other Current Assets (Tables) | 12 Months Ended |
Dec. 31, 2022 | |
Prepaid Expenses and Other Current Assets | |
Schedule of prepaid expenses and other current assets | December 31, 2022 2021 Payroll tax receivable $ 660,891 $ 343,785 Prepaid insurance expenses 201,082 171,370 Prepaid conference expenses 97,743 12,586 Prepaid general and administrative expenses 87,982 71,375 Prepaid rent and security deposit 74,959 32,254 Prepaid patent expenses 38,796 32,797 Other 26,745 4,525 Prepaid research and development expenses 2,521 — Prepaid board of directors fees — 66,250 Total prepaid expenses and other current assets $ 1,190,719 $ 734,942 |
Property and Equipment, Net (Ta
Property and Equipment, Net (Tables) | 12 Months Ended |
Dec. 31, 2022 | |
Property and Equipment, Net | |
Schedule of property and equipment | December 31, 2022 2021 Equipment $ 1,271,372 $ 854,060 Equipment not yet placed in service 90,411 254,864 Leasehold improvements 569,170 490,709 1,930,953 1,599,633 Less: accumulated depreciation and amortization (635,838) (328,408) Property and equipment, net $ 1,295,115 $ 1,271,225 |
Accrued Expenses and Other Cu_2
Accrued Expenses and Other Current Liabilities (Tables) | 12 Months Ended |
Dec. 31, 2022 | |
Accrued Expenses and Other Current Liabilities | |
Schedule of Accrued Expenses and Other Current Liabilities | December 31, 2022 2021 Accrued consulting and professional services $ 320,000 $ 250,000 Accrued leasehold improvements 92,528 — Credit card payable 50,639 20,000 Accrued research and development expenses 35,524 436,840 Other 4,385 42,407 Accrued interest — 94,792 Accrued franchise tax — 1,680 Total accrued expenses and other current liabilities $ 503,076 $ 845,719 |
Accrued Compensation (Tables)
Accrued Compensation (Tables) | 12 Months Ended |
Dec. 31, 2022 | |
Accrued Compensation | |
Schedule of Accrued Compensation | December 31, 2022 2021 Accrued bonus expenses $ 1,447,643 $ 1,245,795 Accrued payroll expenses 299,548 297,823 Total accrued compensation $ 1,747,191 $ 1,543,618 |
Notes Payable and Convertible_2
Notes Payable and Convertible Notes Payable (Tables) | 12 Months Ended |
Dec. 31, 2022 | |
Notes Payable and Convertible Notes Payable | |
Schedule of notes payable | December 31, 2022 December 31, 2021 Notes Payable Debt Discount Net Notes Payable Debt Discount Net Silicon Valley Bank loan $ — $ — $ — $ 7,500,000 $ (349,632) $ 7,150,368 Avenue - Note payable 5,212,500 (847,114) 4,365,386 — — — Avenue - Convertible note payable 5,212,500 (847,114) 4,365,386 — — — Total 10,425,000 (1,694,228) 8,730,772 7,500,000 (349,632) 7,150,368 Less: Current portion Silicon Valley Bank loan — — — (7,500,000) 349,632 $ (7,150,368) Avenue - Note payable (208,333) 33,885 (174,448) — — — Avenue - Convertible note payable (208,333) 33,885 (174,448) — — — Notes Payable, Non-Current $ 10,008,334 $ (1,626,458) $ 8,381,876 $ — $ — $ — |
Schedule of breakdown of the allocation of debt discount and origination costs | Allocation of Debt Discount Withheld Eyenovia Premium- Equity From Origination (Final Equity Total Debt Issuance Allocation % Proceeds Costs Payment) Issued Discount Costs Non-Convertible Note 45.70 % $ 127,916 $ 107,976 $ 212,500 $ 429,867 $ 878,258 $ — Convertible Note 45.70 % 127,916 107,976 212,500 429,867 878,258 — Private Placement Shares 8.60 % 24,063 20,312 — — — 44,376 Total 100.00 % $ 279,895 $ 236,264 $ 425,000 $ 859,734 $ 1,756,516 $ 44,376 Withheld From Closing Proceeds: Broker Fee $ 250,000 Legal Reimbursement 29,895 Total $ 279,895 Eyenovia Origination Costs: Legal Fee $ 86,264 Avenue Management Fee 150,000 Total $ 236,264 |
Summary of Avenue loan | December 31, 2022 Non-Convertible Convertible Total Initial loan funding $ 5,000,000 $ 5,000,000 $ 10,000,000 Final payment 212,500 212,500 425,000 5,212,500 5,212,500 10,425,000 Less: Unamortized debt discount (847,114) (847,114) (1,694,228) 4,365,386 4,365,386 8,730,772 Less: Current portion (174,448) (174,448) (348,896) Notes Payable, Non-Current $ 4,190,938 $ 4,190,938 $ 8,381,876 |
Income Taxes (Tables)
Income Taxes (Tables) | 12 Months Ended |
Dec. 31, 2022 | |
Income Taxes | |
Schedule of provision for income taxes | For The Years Ended December 31, 2022 2021 Deferred tax provision (benefit): Federal 5,879,362 (1,248,043) State and local (208,806) (2,358,623) 5,670,556 (3,606,666) Change in valuation allowance (5,670,556) 3,606,666 Provision for income taxes $ — $ — |
Schedule of effective income tax rate reconciliation | For The Years Ended December 31, 2022 2021 Federal statutory rate (21.0) % (21.0) % State tax rate, net of federal benefit (2.5) % (7.3) % Permanent differences 1.6 % 4.3 % Research & development tax credits (1.0) % (0.6) % Prior period adjustments and other 1.3 % 0.2 % Rate and apportionment changes 1.3 % (3.8) % Change in valuation allowance 20.3 % 28.2 % Effective income tax rate (0.0) % (0.0) % |
Schedule of deferred tax assets | For The Years Ended December 31, 2022 2021 Deferred tax assets: Net operating loss carryforwards $ 20,165,693 $ 17,415,488 Research and development tax credits 799,182 605,919 Capitalized research and development costs 2,304,110 — Stock-based compensation 2,089,014 2,070,759 Intangible assets 633,151 531,454 Lease liability 327,276 — Total gross deferred tax assets 26,318,426 20,623,620 Deferred tax liabilities Property and equipment (184,138) (463,442) Right ot use asset (303,554) — Deferred tax assets, net before allowance 25,830,734 20,160,178 Valuation allowance (25,830,734) (20,160,178) Deferred tax assets, net $ — $ — Changes in valuation allowance $ (5,670,556) $ 3,606,666 |
Commitments and Contingencies (
Commitments and Contingencies (Tables) | 12 Months Ended |
Dec. 31, 2022 | |
Commitments and Contingencies | |
Summary of Company's right-of-use assets and liabilities | For the Year Ended December 31, 2022 Cash paid for amounts included in the measurement of lease liabilities: Operating cash flows used in operating activities $ 412,478 Right-of-use assets obtained in exchange for lease obligations Operating leases $ 1,186,098 Weighted Average Remaining Lease Term (Years) Operating leases 3.71 years Weighted Average Discount Rate Operating leases 10.0 % |
Schedule of future minimum operating lease payments | Future minimum payments under the Company’s operating lease agreements are as follows: For the Year Ending December 31, Minimum Lease Payments 2023 $ 588,181 2024 278,254 2025 289,887 2026 302,039 2027 216,126 Total lease payments 1,674,487 Less: Imputed interest (281,961) Present value of lease liabilities 1,392,526 Less: current portion (484,882) Lease liabilities, non-current portion $ 907,644 |
Stockholders' Equity (Tables)
Stockholders' Equity (Tables) | 12 Months Ended |
Dec. 31, 2022 | |
Stockholders' Equity | |
Schedule of Restricted Stock Units Activity | Number of Exercise RSUs Price RSUs non-vested January 1, 2022 41,778 $ 3.59 Granted 193,304 1.93 Vested (55,319) 3.37 Forfeited (6,963) 3.59 RSUs non-vested December 31, 2022 172,800 $ 1.80 Vested RSUs undelivered December 31, 2022 32,900 $ 3.59 |
Schedule of the warrant activity and related information | Weighted Weighted Average Average Remaining Aggregate Number of Exercise Life Intrinsic Warrants Price In Years Value Outstanding January 1, 2022 1,217,715 $ 2.69 Granted 6,740,260 2.56 Exercised (1,870,130) 0.01 Outstanding December 31, 2022 6,087,845 $ 3.37 4.3 $ — Exercisable December 31, 2022 6,087,845 $ 3.37 4.3 $ — |
Schedule of Black-Scholes option pricing model to stock options granted, assumption used | For the Year Ended December 31, 2022 2021 Expected term (years) 0.58 - 10.00 5.85 - 10.00 Risk free interest rate 0.76% - 3.80% 0.45% - 1.58% Expected volatility 82% - 90% 92% - 94% Expected dividends 0.00% 0.00% |
Schedule of the stock option activity | Weighted Weighted Average Average Remaining Aggregate Number of Exercise Life Intrinsic Options Price In Years Value Outstanding, January 1, 2022 4,377,398 $ 3.89 Granted 1,181,310 2.23 Exercised — — Forfeited (178,155) 3.01 Outstanding, December 31, 2022 5,380,553 $ 3.55 7.2 $ 85,800 Exercisable, December 31, 2022 3,614,195 $ 3.79 6.4 $ 85,800 |
Schedule of information related to stock options | The following table presents information related to stock options as of December 31, 2022: Options Outstanding Options Exercisable Weighted Outstanding Average Exercisable Exercise Number of Remaining Life Number of Price Options In Years Options $1.00 - $1.99 1,517,952 3.8 754,302 $2.00 - $2.99 1,010,018 7.4 847,485 $3.00 - $3.99 1,202,539 6.8 804,840 $4.00 - $4.99 383,500 8.5 193,623 $5.00 - $5.99 100,805 6.0 83,972 $6.00 - $6.99 1,000,821 7.0 765,055 $7.00+ 164,918 5.3 164,918 5,380,553 6.4 3,614,195 |
Schedule of warrants outstanding | Warrants Outstanding Warants Exercisable Weighted Outstanding Average Exercisable Exercise Number of Remaining Life Number of Price Warrants In Years Warrants $2.4696 909,451 2.2 909,451 $2.7240 216,380 2.2 216,380 $4.7600 91,884 8.3 91,884 $3.5400 4,870,130 4.7 4,870,130 6,087,845 4.3 6,087,845 |
Business Organization and Nat_2
Business Organization and Nature of Operations (Details) | 12 Months Ended |
Dec. 31, 2022 | |
Business Organization and Nature of Operations | |
High rate of Optejet | 98% |
Rate of traditional eye drops | 50% |
Summary of Significant Accoun_4
Summary of Significant Accounting Policies - Anti-dilutive weighted average diluted common shares (Details) - USD ($) | 12 Months Ended | |
Dec. 31, 2022 | Dec. 31, 2021 | |
Summary of Significant Accounting Policies | ||
Total potentially dilutive shares | 11,641,198 | 5,636,891 |
Numerator: | ||
Net income (loss) | $ (28,011,157) | $ (12,778,387) |
Net loss attributable to common stockholders | $ (28,011,157) | $ (12,778,387) |
Denominator (weighted average quantities): | ||
Common shares issued | 33,252,644 | 26,238,134 |
Add: Prefunded warrants | 333,037 | |
Add: Undelivered vested restricted shares | 64,066 | 85,947 |
Weighted Average Number of Shares Outstanding, Diluted | 33,649,747 | 26,324,081 |
Denominator for basic net loss per share | 33,649,747 | 26,324,081 |
Denominator for diluted net loss per share | 33,649,747 | 26,324,081 |
Basic net loss per share of common stock | $ (0.83) | $ (0.49) |
Diluted net loss per share of common stock | $ (0.83) | $ (0.49) |
Warrants | ||
Summary of Significant Accounting Policies | ||
Total potentially dilutive shares | 6,087,845 | 1,217,715 |
Options | ||
Summary of Significant Accounting Policies | ||
Total potentially dilutive shares | 5,380,553 | 4,377,398 |
Restricted stock units | ||
Summary of Significant Accounting Policies | ||
Total potentially dilutive shares | 172,800 | 41,778 |
Summary of Significant Accoun_5
Summary of Significant Accounting Policies - Additional Information (Details) - USD ($) | 1 Months Ended | 12 Months Ended | |||||||
Mar. 10, 2023 | Nov. 04, 2022 | Mar. 03, 2022 | Sep. 17, 2021 | Oct. 09, 2020 | Aug. 31, 2020 | Dec. 31, 2022 | Dec. 31, 2021 | Mar. 31, 2023 | |
Summary of Significant Accounting Policies | |||||||||
Cash and cash equivalents | $ 22,863,520 | $ 19,461,850 | |||||||
Accumulated deficit | (118,230,463) | (90,219,306) | |||||||
Net loss | (28,011,157) | (12,778,387) | |||||||
Cash used in operations | (25,105,482) | (20,874,432) | |||||||
Amount pledged to establish and maintain a collateralized money market account | 7,875,000 | ||||||||
Cash, uninsured amount | 22,613,520 | 19,211,850 | |||||||
Restricted cash used for substantial repayment | $ 7,875,000 | ||||||||
Operating lease right-of-use asset | 1,291,592 | ||||||||
Operating lease, liabilities | 907,644 | ||||||||
Derecognizing deferred rent | 39,000 | ||||||||
Deferred clinical supply costs | 2,284,931 | ||||||||
ASU adoption adjustment | |||||||||
Summary of Significant Accounting Policies | |||||||||
Operating lease right-of-use asset | 580,000 | ||||||||
Operating lease, liabilities | 619,000 | ||||||||
Senju Pharmaceutical | |||||||||
Summary of Significant Accounting Policies | |||||||||
Upfront payments | $ 250,000 | ||||||||
Bausch License Agreement | |||||||||
Summary of Significant Accounting Policies | |||||||||
Upfront payment received | 10,000,000 | ||||||||
Written notice period | 90 days | ||||||||
Bausch License Agreement | 60 days | ||||||||
Milestone payments earned | 0 | ||||||||
Royalty payments earned | 0 | ||||||||
Maximum additional payments receivable | $ 35,000,000 | ||||||||
Arctic Vision License Agreement | |||||||||
Summary of Significant Accounting Policies | |||||||||
Upfront payment received | $ 4,000,000 | $ 4,000,000 | |||||||
Aggregate milestone revenue related to filing of marketing authorization applications | 13,200,000 | ||||||||
Receipt of regulatory approvals | 24,500,000 | ||||||||
Royalty payments earned | 0 | ||||||||
Maximum additional payments receivable | 37,700,000 | ||||||||
Arctic Vision License Agreement | Senju Pharmaceutical | |||||||||
Summary of Significant Accounting Policies | |||||||||
Upfront payments | 250,000 | ||||||||
Arctic Vision License Agreement | Senju Pharmaceutical | Cost of sales | |||||||||
Summary of Significant Accounting Policies | |||||||||
Payment made form upfront license fee | $ 1,600,000 | ||||||||
Securities purchase agreement | |||||||||
Summary of Significant Accounting Policies | |||||||||
Net proceeds (in shares) | 250,000 | 3,000,000 | |||||||
Clinical Supply Arrangements | |||||||||
Summary of Significant Accounting Policies | |||||||||
Clinical trials, percentage of additional mark-up on cost | 10% | ||||||||
Deferred clinical supply costs | $ 2,300,000 | ||||||||
Net income from the sale of clinical supplies | $ 200,000 | ||||||||
Maximum | |||||||||
Summary of Significant Accounting Policies | |||||||||
Estimated useful Life | 10 years | ||||||||
Percentage of payment of royalties | 40% | ||||||||
Minimum | |||||||||
Summary of Significant Accounting Policies | |||||||||
Estimated useful Life | 1 year | ||||||||
Percentage of payment of royalties | 30% | ||||||||
Subsequent Event | Securities purchase agreement | Silicon Valley Bank loan | Pre-funded warrants | |||||||||
Summary of Significant Accounting Policies | |||||||||
Cash and cash equivalents | $ 194,000 |
Prepaid Expenses and Other Cu_3
Prepaid Expenses and Other Current Assets (Details) - USD ($) | Dec. 31, 2022 | Dec. 31, 2021 |
Prepaid Expenses and Other Current Assets | ||
Payroll tax receivable | $ 660,891 | $ 343,785 |
Prepaid insurance expenses | 201,082 | 171,370 |
Prepaid conference expenses | 97,743 | 12,586 |
Prepaid general and administrative expenses | 87,982 | 71,375 |
Prepaid rent and security deposit | 74,959 | 32,254 |
Prepaid patent expenses | 38,796 | 32,797 |
Other | 26,745 | 4,525 |
Prepaid research and development expenses | 2,521 | 0 |
Prepaid board of directors fees | 0 | 66,250 |
Total prepaid expenses and other current assets | $ 1,190,719 | $ 734,942 |
Property and Equipment, Net - P
Property and Equipment, Net - Property and Equipment (Details) - USD ($) | Dec. 31, 2022 | Dec. 31, 2021 |
Property and Equipment, Net | ||
Property and equipment, gross | $ 1,930,953 | $ 1,599,633 |
Less: accumulated depreciation and amortization | (635,838) | (328,408) |
Property and equipment, net | 1,295,115 | 1,271,225 |
Equipment | ||
Property and Equipment, Net | ||
Property and equipment, gross | 1,271,372 | 854,060 |
Equipment not yet placed in service | ||
Property and Equipment, Net | ||
Property and equipment, gross | 90,411 | 254,864 |
Leasehold improvements | ||
Property and Equipment, Net | ||
Property and equipment, gross | $ 569,170 | $ 490,709 |
Property and Equipment, Net - A
Property and Equipment, Net - Additional Information (Details) - USD ($) | 12 Months Ended | |
Dec. 31, 2022 | Dec. 31, 2021 | |
Property and Equipment, Net | ||
Depreciation expense | $ 307,430 | $ 221,563 |
Research and development expenses | 13,378,680 | 14,850,874 |
General and administrative expenses | 13,532,835 | 10,569,653 |
Outstanding deposits of property and equipments | 334,385 | 391,941 |
Equipment | ||
Property and Equipment, Net | ||
Outstanding deposits of property and equipments | 726,326 | 391,941 |
Property and Equipment | ||
Property and Equipment, Net | ||
Depreciation expense | 307,430 | 221,563 |
Research and development expenses | 301,205 | 211,604 |
General and administrative expenses | $ 6,225 | $ 9,959 |
Accrued Expenses and Other Cu_3
Accrued Expenses and Other Current Liabilities (Details) - USD ($) | Dec. 31, 2022 | Dec. 31, 2021 |
Accrued Expenses and Other Current Liabilities | ||
Accrued consulting and professional services | $ 320,000 | $ 250,000 |
Accrued leasehold improvements | 92,528 | 0 |
Credit card payable | 50,639 | 20,000 |
Accrued research and development expenses | 35,524 | 436,840 |
Other | 4,385 | 42,407 |
Accrued interest | 0 | 94,792 |
Accrued franchise tax | 0 | 1,680 |
Total accrued expenses and other current liabilities | $ 503,076 | $ 845,719 |
Accrued Compensation (Details)
Accrued Compensation (Details) - USD ($) | Dec. 31, 2022 | Dec. 31, 2021 |
Accrued Compensation | ||
Accrued bonus expenses | $ 1,447,643 | $ 1,245,795 |
Accrued payroll expenses | 299,548 | 297,823 |
Total accrued compensation | $ 1,747,191 | $ 1,543,618 |
Notes Payable and Convertible_3
Notes Payable and Convertible Notes Payable - Schedule of notes payable and convertible notes payable (Details) - USD ($) | Dec. 31, 2022 | Dec. 31, 2021 |
Notes Payable and Convertible Notes Payable | ||
Notes Payable, Total | $ 10,425,000 | $ 7,500,000 |
Debt Discount, Total | (1,694,228) | (349,632) |
Notes payable, Net of Debt Discount, Total | 8,730,772 | 7,150,368 |
Notes Payable, Non-Current | 10,008,334 | |
Debt Discount, Non-Current portion | (1,626,458) | |
Notes Payable Non Current, Net of Debt Discount Non Current, Non Current Portion | 8,381,876 | |
Non-current portion of convertible notes payable, net of discount | 4,190,938 | |
Silicon Valley Bank loan | ||
Notes Payable and Convertible Notes Payable | ||
Notes Payable, Total | 7,500,000 | |
Debt Discount, Total | (349,632) | |
Notes payable, Net of Debt Discount, Total | 7,150,368 | |
Notes Payable, current | (7,500,000) | |
Debt Discount, Current portion | 349,632 | |
Notes Payable Current, Net of Debt Discount Current, Current Portion | $ (7,150,368) | |
Avenue - Note payable | ||
Notes Payable and Convertible Notes Payable | ||
Notes Payable, Total | 5,212,500 | |
Debt Discount, Total | (847,114) | |
Notes payable, Net of Debt Discount, Total | 4,365,386 | |
Notes Payable, current | (208,333) | |
Debt Discount, Current portion | 33,885 | |
Notes Payable Current, Net of Debt Discount Current, Current Portion | (174,448) | |
Avenue - Convertible note payable | ||
Notes Payable and Convertible Notes Payable | ||
Notes Payable, Total | 5,212,500 | |
Debt Discount, Total | (847,114) | |
Notes payable, Net of Debt Discount, Total | 4,365,386 | |
Notes Payable, current | (208,333) | |
Debt Discount, Current portion | 33,885 | |
Notes Payable Current, Net of Debt Discount Current, Current Portion | $ (174,448) |
Notes Payable and Convertible_4
Notes Payable and Convertible Notes Payable - Additional Information (Details) - USD ($) | 12 Months Ended | ||||||||||
Nov. 04, 2022 | Feb. 24, 2022 | May 07, 2021 | Feb. 24, 2021 | May 08, 2020 | Dec. 31, 2022 | Dec. 31, 2021 | Nov. 22, 2022 | Aug. 24, 2022 | Sep. 29, 2021 | Aug. 31, 2021 | |
Notes Payable and Convertible Notes Payable | |||||||||||
Short term notes payable | $ 174,448 | $ 7,150,368 | |||||||||
Aggregate principal payments | $ 7,500,000 | ||||||||||
Amount pledged to establish and maintain a collateralized money market account | 7,875,000 | ||||||||||
Number of warrants issued | 1,870,130 | ||||||||||
Exercise price | $ 0.01 | ||||||||||
Fair value of warrants | 354,539 | ||||||||||
Payments of debt issuance costs | $ 0 | 66,618 | |||||||||
Repayments of long-term debt, total | 8,025,000 | ||||||||||
Final payment of loan | $ (375,000) | ||||||||||
Percentage of prepayment fees | 2% | ||||||||||
Prepayment fees | $ (150,000) | ||||||||||
Restricted cash used for substantial repayment | $ 7,875,000 | ||||||||||
Avenue Ventures Loan | |||||||||||
Notes Payable and Convertible Notes Payable | |||||||||||
Interest rate (as a percent) | 7% | ||||||||||
Share price | $ 1.79 | ||||||||||
Interest expense | 189,510 | ||||||||||
Amortization of debt discount | $ 62,288 | ||||||||||
Paycheck Protection Program Loan | |||||||||||
Notes Payable and Convertible Notes Payable | |||||||||||
Debt Instrument, Periodic Payment | $ 19,508 | ||||||||||
Interest rate (as a percent) | 1% | ||||||||||
Cash proceeds from loan | $ 463,353 | ||||||||||
Amount of principal forgiveness on PPP loan | $ 463,353 | ||||||||||
Amount of accrued interest forgiveness on PPP loan | $ 5,738 | ||||||||||
Notes payable | |||||||||||
Notes Payable and Convertible Notes Payable | |||||||||||
Short term notes payable | $ 714,087 | ||||||||||
Silicon Valley Bank loan | |||||||||||
Notes Payable and Convertible Notes Payable | |||||||||||
Interest rate (as a percent) | 5% | ||||||||||
Maturity date | May 01, 2025 | ||||||||||
Aggregate principal amount | $ 25,000,000 | ||||||||||
Debt instrument effective stated rate | 1.25% plus the prime rate | ||||||||||
Long-term Debt | $ 7,500,000 | ||||||||||
Aggregate loan percentage | 5% | ||||||||||
Amount pledged to establish and maintain a collateralized money market account | $ 7,875,000 | ||||||||||
Number of warrants issued | 91,884 | ||||||||||
Exercise price | $ 4.76 | ||||||||||
Warrant exercisable term | 10 years | ||||||||||
Payments of debt issuance costs | $ 66,618 | ||||||||||
Interest expense | 1,174,736 | 317,333 | |||||||||
Amortization of debt discount | 349,632 | 68,376 | |||||||||
Silicon Valley Bank loan | Debt | |||||||||||
Notes Payable and Convertible Notes Payable | |||||||||||
Loan issuance costs | 63,469 | ||||||||||
Silicon Valley Bank loan | Warrants | |||||||||||
Notes Payable and Convertible Notes Payable | |||||||||||
Fair value of warrants | $ 354,539 | ||||||||||
Share price | $ 4.76 | ||||||||||
Expected term (years) | 10 years | ||||||||||
Expected volatility | 89% | ||||||||||
Risk free interest rate | 1.60% | ||||||||||
Loan issuance costs | $ 3,149 | ||||||||||
Silicon Valley Bank loan | Prior to second anniversary | |||||||||||
Notes Payable and Convertible Notes Payable | |||||||||||
Prepayment fee percentage | 2% | ||||||||||
Directors And Officers Insurance Policy Loan [Member] | |||||||||||
Notes Payable and Convertible Notes Payable | |||||||||||
Number of monthly payments | 6 months | 9 months | |||||||||
Debt Instrument, Periodic Payment | $ 113,628 | $ 79,343 | |||||||||
Short term notes payable | $ 681,768 | ||||||||||
Interest rate (as a percent) | 2.96% | 3.26% | |||||||||
Maturity date | Aug. 24, 2022 | Nov. 24, 2021 | |||||||||
Interest expense | $ 6,436 | $ 8,727 |
Notes Payable and Convertible_5
Notes Payable and Convertible Notes Payable - Avenue Ventures Loan (Details) - USD ($) | 12 Months Ended | |||
Dec. 01, 2022 | Nov. 22, 2022 | Dec. 31, 2022 | Dec. 31, 2021 | |
Notes Payable and Convertible Notes Payable | ||||
Relative fair value of shares granted | $ 859,733 | |||
Unamortized debt discount | 1,694,228 | $ 349,632 | ||
Avenue Ventures Loan | ||||
Notes Payable and Convertible Notes Payable | ||||
Aggregate principal amount | $ 15,000,000 | |||
Conversion of principal amount outstanding | $ 5,000,000 | |||
Conversion price | $ 2.148 | |||
Interest rate (as a percent) | 7% | |||
Additional borrowing amount | $ 5,000,000 | |||
Incremental final payment (as percent) | 4.25% | |||
Final Payment premium | $ 425,000 | 425,000 | ||
Percent of prepayment fee during first year | 3% | |||
Percent of prepayment fee during second year | 2% | |||
Percent of prepayment fee during third year | 1% | |||
Portfolio management fee (as percent) | 1% | |||
Total commitment | $ 15,000,000 | |||
Portfolio management fee amount | $ 150,000 | |||
Aggregate shares granted | 547,807 | |||
Stock price per share | $ 1.79 | |||
Gross value of shares granted | $ 980,575 | |||
Relative fair value of shares granted | $ 859,734 | |||
Total debt discount | 1,756,516 | |||
Current year amortization of loan | 62,288 | |||
Unamortized debt discount | $ 1,694,228 | |||
Avenue Ventures Loan | Minimum | ||||
Notes Payable and Convertible Notes Payable | ||||
Monthly interest-only payments period (in months) | 12 months | |||
Avenue Ventures Loan | Maximum | ||||
Notes Payable and Convertible Notes Payable | ||||
Monthly interest-only payments period (in months) | 18 months | |||
Avenue Ventures Loan | Prime Rate | ||||
Notes Payable and Convertible Notes Payable | ||||
Basis spread on variable rate | 4.45% | |||
Avenue Ventures Loan | Initial tranche of Avenue Loan | ||||
Notes Payable and Convertible Notes Payable | ||||
Aggregate principal amount | $ 10,000,000 | |||
Avenue Ventures Loan | Avenue, the Lender | Initial tranche of Avenue Loan | ||||
Notes Payable and Convertible Notes Payable | ||||
Aggregate principal amount | 4,000,000 | |||
Avenue Ventures Loan | Avenue 2 | Initial tranche of Avenue Loan | ||||
Notes Payable and Convertible Notes Payable | ||||
Aggregate principal amount | $ 6,000,000 |
Notes Payable and Convertible_6
Notes Payable and Convertible Notes Payable - Allocation of debt discount and origination costs (Details) - Avenue Ventures Loan - USD ($) | 12 Months Ended | |
Dec. 31, 2022 | Nov. 22, 2022 | |
Allocation of Debt Discount | ||
Allocation % | 100% | |
Withheld From Proceeds | $ 279,895 | |
Eyenovia Origination Costs | 236,264 | |
Final Payment premium | 425,000 | $ 425,000 |
Common shares issued recorded as debt discount for Avenue Loan | 859,734 | |
Total debt discount | 1,756,516 | |
Equity Issuance Costs | 44,376 | |
Broker Fee | ||
Allocation of Debt Discount | ||
Withheld From Proceeds | 250,000 | |
Legal Reimbursement | ||
Allocation of Debt Discount | ||
Withheld From Proceeds | 29,895 | |
Legal Fee | ||
Allocation of Debt Discount | ||
Eyenovia Origination Costs | 86,264 | |
Avenue Management Fee | ||
Allocation of Debt Discount | ||
Eyenovia Origination Costs | $ 150,000 | |
Non-Convertible Note | ||
Allocation of Debt Discount | ||
Allocation % | 45.70% | |
Withheld From Proceeds | $ 127,916 | |
Eyenovia Origination Costs | 107,976 | |
Final Payment premium | 212,500 | |
Common shares issued recorded as debt discount for Avenue Loan | 429,867 | |
Total debt discount | $ 878,258 | |
Convertible Notes Payable [Member] | ||
Allocation of Debt Discount | ||
Allocation % | 45.70% | |
Withheld From Proceeds | $ 127,916 | |
Eyenovia Origination Costs | 107,976 | |
Final Payment premium | 212,500 | |
Common shares issued recorded as debt discount for Avenue Loan | 429,867 | |
Total debt discount | $ 878,258 | |
Private Placement Shares | ||
Allocation of Debt Discount | ||
Allocation % | 8.60% | |
Withheld From Proceeds | $ 24,063 | |
Eyenovia Origination Costs | 20,312 | |
Equity Issuance Costs | $ 44,376 |
Notes Payable and Convertible_7
Notes Payable and Convertible Notes Payable - Summary of Avenue loan (Details) - USD ($) | Dec. 31, 2022 | Nov. 22, 2022 | Dec. 31, 2021 |
Notes Payable and Convertible Notes Payable | |||
Total before unamortized debt discount | $ 10,425,000 | $ 7,500,000 | |
Debt Discount, Total | (1,694,228) | (349,632) | |
Total | 8,730,772 | $ 7,150,368 | |
Notes Payable, Non-Current | 8,381,876 | ||
Avenue Ventures Loan | |||
Notes Payable and Convertible Notes Payable | |||
Initial loan funding | 10,000,000 | ||
Final Payment premium | 425,000 | $ 425,000 | |
Total before unamortized debt discount | 10,425,000 | ||
Debt Discount, Total | (1,694,228) | ||
Total | 8,730,772 | ||
Less: Current portion | (348,896) | ||
Notes Payable, Non-Current | 8,381,876 | ||
Avenue Ventures Loan | Non-Convertible Note | |||
Notes Payable and Convertible Notes Payable | |||
Initial loan funding | 5,000,000 | ||
Final Payment premium | 212,500 | ||
Total before unamortized debt discount | 5,212,500 | ||
Debt Discount, Total | (847,114) | ||
Total | 4,365,386 | ||
Less: Current portion | (174,448) | ||
Notes Payable, Non-Current | 4,190,938 | ||
Avenue Ventures Loan | Convertible Note | |||
Notes Payable and Convertible Notes Payable | |||
Initial loan funding | 5,000,000 | ||
Final Payment premium | 212,500 | ||
Total before unamortized debt discount | 5,212,500 | ||
Debt Discount, Total | (847,114) | ||
Total | 4,365,386 | ||
Less: Current portion | (174,448) | ||
Notes Payable, Non-Current | $ 4,190,938 |
Income Taxes - Provision for in
Income Taxes - Provision for income taxes (Details) - USD ($) | 12 Months Ended | |
Dec. 31, 2022 | Dec. 31, 2021 | |
Deferred tax provision (benefit): | ||
Federal | $ 5,879,362 | $ (1,248,043) |
State and local | (208,806) | (2,358,623) |
Total | 5,670,556 | (3,606,666) |
Change in valuation allowance | $ (5,670,556) | $ 3,606,666 |
Income Taxes - Effective income
Income Taxes - Effective income tax rate reconciliation (Details) | 12 Months Ended | |
Dec. 31, 2022 | Dec. 31, 2021 | |
Income Taxes | ||
Federal statutory rate | (21.00%) | (21.00%) |
State tax rate, net of federal benefit | (2.50%) | (7.30%) |
Permanent differences | 1.60% | 4.30% |
Research & development tax credits | (1.00%) | (0.60%) |
Prior period adjustments and other | 1.30% | 0.20% |
Rate changes | 1.30% | (3.80%) |
Change in valuation allowance | 20.30% | 28.20% |
Effective income tax rate | 0% | 0% |
Income Taxes - Deferred tax ass
Income Taxes - Deferred tax assets (Details) - USD ($) | 12 Months Ended | |
Dec. 31, 2022 | Dec. 31, 2021 | |
Deferred tax assets: | ||
Net operating loss carry forwards | $ 20,165,693 | $ 17,415,488 |
Research and development tax credits | 799,182 | 605,919 |
Capitalized research and development costs | 2,304,110 | |
Stock-based compensation | 2,089,014 | 2,070,759 |
Intangible assets | 633,151 | 531,454 |
Lease liability | 327,276 | |
Total gross deferred tax assets | 26,318,426 | 20,623,620 |
Deferred tax liabilities | ||
Property and equipment | (184,138) | (463,442) |
Right ot use asset | (303,554) | |
Deferred tax assets, net before allowance | 25,830,734 | 20,160,178 |
Valuation allowance | (25,830,734) | (20,160,178) |
Change in valuation allowance | $ (5,670,556) | $ 3,606,666 |
Income Taxes - Additional infor
Income Taxes - Additional information (Details) - USD ($) | 12 Months Ended | |
Dec. 31, 2022 | Dec. 31, 2021 | |
Income Taxes | ||
Operating loss carryforwards | $ 85,900,000 | |
Operating loss carryforwards, subject to expiration | $ 10,800,000 | |
Operating loss carry forwards expiration term | 2034 to 2037 | |
Operating loss carryforwards, not subject to expiration | $ 75,100,000 | |
Net operating loss limit for utilization as per internal revenue code | 35,000,000 | |
Net operating loss annual utilization limit as per internal revenue code | 918,000 | |
Tax related interest or penalties were incurred | 0 | $ 0 |
State | ||
Income Taxes | ||
Operating loss carryforwards | 25,400,000 | |
Local | ||
Income Taxes | ||
Operating loss carryforwards | $ 6,400,000 | |
Operating loss carryforwards, subject to expiration | $ 25,300,000 | |
Operating loss carry forwards expiration term | 2040 to 2042 | |
Operating loss carryforwards, not subject to expiration | $ 100,000 |
Commitments and Contingencies -
Commitments and Contingencies - Additional Information (Details) | 12 Months Ended | |||||||||
Jul. 26, 2022 USD ($) $ / shares shares | May 19, 2022 USD ($) ft² | Apr. 08, 2022 USD ($) ft² | Dec. 01, 2020 USD ($) ft² | Jul. 17, 2020 USD ($) ft² | Jan. 20, 2020 USD ($) ft² | Aug. 08, 2018 USD ($) ft² | Aug. 08, 2018 USD ($) ft² | Dec. 31, 2022 USD ($) ft² $ / shares | Dec. 31, 2021 USD ($) $ / shares | |
Commitments and Contingencies | ||||||||||
Weighted Average Exercise Price, Granted | $ / Shares | $ / shares | $ 1.60 | $ 5.39 | ||||||||
Mr. Rowe | ||||||||||
Commitments and Contingencies | ||||||||||
Annual salary | $ 575,000 | |||||||||
Maximum cash bonus percentage | 60% | |||||||||
Number of options to purchase common stock, shares issued | shares | 440,000 | |||||||||
Weighted Average Exercise Price, Granted | $ / Shares | $ / shares | $ 1.66 | |||||||||
Aggregate potential severance pay for executive officers | $ 1,004,000 | |||||||||
Dr. Ianchulev, Executive Chairman | ||||||||||
Commitments and Contingencies | ||||||||||
Initial period of service | 1 year | |||||||||
Monthly retainer | $ 5,000 | |||||||||
Lease Agreement For Office Located In New York, NY [Member] | ||||||||||
Commitments and Contingencies | ||||||||||
Net rentable area | ft² | 3,800 | 3,800 | ||||||||
Lease expiration date | Sep. 30, 2023 | |||||||||
Security deposits | $ 118,000 | $ 118,000 | ||||||||
Lease Agreement For Office Located In New York, NY [Member] | Minimum | ||||||||||
Commitments and Contingencies | ||||||||||
Lease payments | 19,633 | |||||||||
Lease Agreement For Office Located In New York, NY [Member] | Maximum | ||||||||||
Commitments and Contingencies | ||||||||||
Lease payments | $ 22,486 | |||||||||
Lease Agreement For Office Located In Laguna Hills California [Member] | ||||||||||
Commitments and Contingencies | ||||||||||
Net rentable area | ft² | 660 | |||||||||
Operating lease, term of contract | 1 year | |||||||||
Lease expiration date | Apr. 30, 2022 | |||||||||
Security deposits | $ 1,254 | |||||||||
Rent expense | $ 20,501 | $ 29,424 | ||||||||
Lease Agreement For Office Located In Laguna Hills California [Member] | Minimum | ||||||||||
Commitments and Contingencies | ||||||||||
Lease payments | 1,254 | |||||||||
Lease Agreement For Office Located In Laguna Hills California [Member] | Maximum | ||||||||||
Commitments and Contingencies | ||||||||||
Lease payments | $ 1,292 | |||||||||
Lease Agreement For Office Located In Laguna Hills California [Member] | Additional Office Space | ||||||||||
Commitments and Contingencies | ||||||||||
Net rentable area | ft² | 660 | |||||||||
Lease expiration date | Apr. 30, 2023 | |||||||||
Security deposits | $ 1,750 | |||||||||
Lease Agreement For Office Located In Laguna Hills California [Member] | Additional Office Space | Minimum | ||||||||||
Commitments and Contingencies | ||||||||||
Lease payments | 1,750 | |||||||||
Lease Agreement For Office Located In Laguna Hills California [Member] | Additional Office Space | Maximum | ||||||||||
Commitments and Contingencies | ||||||||||
Lease payments | $ 1,838 | |||||||||
Lease Agreement For New Office Located In Laguna Hills California [Member] | ||||||||||
Commitments and Contingencies | ||||||||||
Operating lease, term of contract | 5 years 2 months | |||||||||
Area of Land | ft² | 3,916 | |||||||||
Lease expiration date | Jul. 31, 2027 | |||||||||
Security deposits | $ 11,400 | |||||||||
Lease Agreement For New Office Located In Laguna Hills California [Member] | Minimum | ||||||||||
Commitments and Contingencies | ||||||||||
Lease payments | 9,203 | |||||||||
Lease Agreement For New Office Located In Laguna Hills California [Member] | Maximum | ||||||||||
Commitments and Contingencies | ||||||||||
Lease payments | $ 10,358 | |||||||||
Lease Agreement For Office Located In Redwood City, California [Member] | ||||||||||
Commitments and Contingencies | ||||||||||
Net rentable area | ft² | 3,000 | |||||||||
Lease payments | $ 7,500 | |||||||||
Security deposits | $ 7,500 | |||||||||
Lease Agreement For Office Located In Redwood City, California [Member] | Minimum | ||||||||||
Commitments and Contingencies | ||||||||||
Lease payments | $ 7,500 | |||||||||
Lease Agreement For Office Located In Redwood City, California [Member] | Maximum | ||||||||||
Commitments and Contingencies | ||||||||||
Lease payments | $ 7,957 | |||||||||
Lease Agreement For Office Located In Redwood City, California [Member] | Additional Office Space | ||||||||||
Commitments and Contingencies | ||||||||||
Net rentable area | ft² | 1,500 | |||||||||
Lease expiration date | Aug. 31, 2023 | |||||||||
Security deposits | $ 3,000 | |||||||||
Lease Agreement For Office Located In Redwood City, California [Member] | Additional Office Space | Minimum | ||||||||||
Commitments and Contingencies | ||||||||||
Lease payments | 3,000 | |||||||||
Lease Agreement For Office Located In Redwood City, California [Member] | Additional Office Space | Maximum | ||||||||||
Commitments and Contingencies | ||||||||||
Lease payments | $ 3,183 | |||||||||
Lease Agreement For Office Located In Redwood City, California [Member] | Additional office space as per amendment | ||||||||||
Commitments and Contingencies | ||||||||||
Net rentable area | ft² | 2,169 | |||||||||
Lease expiration date | Aug. 31, 2023 | |||||||||
Security deposits | $ 4,468 | |||||||||
Lease Agreement For Office Located In Redwood City, California [Member] | Additional office space as per amendment | Minimum | ||||||||||
Commitments and Contingencies | ||||||||||
Lease payments | 4,468 | |||||||||
Lease Agreement For Office Located In Redwood City, California [Member] | Additional office space as per amendment | Maximum | ||||||||||
Commitments and Contingencies | ||||||||||
Lease payments | $ 4,602 | |||||||||
Lease Agreement For Office Located In Reno Nevada [Member] | ||||||||||
Commitments and Contingencies | ||||||||||
Operating lease, term of contract | 5 years 4 months | |||||||||
Area of Land | ft² | 10,880 | |||||||||
Lease expiration date | Sep. 23, 2027 | |||||||||
Security deposits | $ 53,000 | |||||||||
Lease Agreement For Office Located In Reno Nevada [Member] | Minimum | ||||||||||
Commitments and Contingencies | ||||||||||
Lease payments | 13,056 | |||||||||
Lease Agreement For Office Located In Reno Nevada [Member] | Maximum | ||||||||||
Commitments and Contingencies | ||||||||||
Lease payments | $ 16,663 | |||||||||
General and Administrative Expense | Lease Agreement For Office Located In New York, NY [Member] | ||||||||||
Commitments and Contingencies | ||||||||||
Rent expense | $ 242,067 | |||||||||
General and Administrative Expense | Lease Agreement For New Office Located In Laguna Hills California [Member] | ||||||||||
Commitments and Contingencies | ||||||||||
Rent expense | 66,196 | 0 | ||||||||
Research And Development Expense | Lease Agreement For Office Located In Redwood City, California [Member] | Additional office space as per amendment | ||||||||||
Commitments and Contingencies | ||||||||||
Rent expense | 180,240 | 128,560 | ||||||||
Research And Development Expense | Lease Agreement For Office Located In Reno Nevada [Member] | ||||||||||
Commitments and Contingencies | ||||||||||
Rent expense | $ 101,023 | |||||||||
Vice President of Research And Development | ||||||||||
Commitments and Contingencies | ||||||||||
Net rentable area | ft² | 953 | |||||||||
Lease payments | $ 5,675 | |||||||||
Security deposits | 5,675 | |||||||||
Leasehold improvements | 112,600 | |||||||||
Rent expense | $ 68,498 | $ 64,848 |
Commitments and Contingencies_2
Commitments and Contingencies - Companys right-of-use assets and liabilities (Details) | 12 Months Ended |
Dec. 31, 2022 USD ($) | |
Commitments and Contingencies | |
Cash paid for amounts included in the measurement of lease liabilities: Operating cash flows used in operating activities | $ 412,478 |
Right-of-use assets obtained in exchange for lease obligations; Operating leases | $ 1,186,098 |
Weighted Average Remaining Lease Term (Years): Operating leases | 3 years 8 months 15 days |
Weighted Average Discount Rate: Operating leases | 10% |
Commitments and Contingencies_3
Commitments and Contingencies - Future Minimum Payments under Operating Lease Agreement (Details) | Dec. 31, 2022 USD ($) |
Minimum Lease Payments | |
2023 | $ 588,181 |
2024 | 278,254 |
2025 | 289,887 |
2026 | 302,039 |
2027 | 216,126 |
Total lease payments | 1,674,487 |
Less: Imputed interest | (281,961) |
Present value of lease liabilities | 1,392,526 |
Less: current portion | (484,882) |
Operating lease liabilities - non-current portion | $ 907,644 |
Related Party Transactions (Det
Related Party Transactions (Details) - USD ($) | 12 Months Ended | |||
Sep. 17, 2021 | Apr. 08, 2020 | Dec. 31, 2022 | Dec. 31, 2015 | |
Related Party Transactions | ||||
Percentage of royalty to be transferred, Range1 | 30% | |||
Percentage of royalty to be transferred, Range2 | 40% | |||
Senju Pharmaceutical | ||||
Related Party Transactions | ||||
Royalty percentage | 5% | |||
Upfront payments | $ 250,000 | |||
Due to related party | $ 9,000,000 | |||
Percentage of royalty to be transferred, Range1 | 30% | |||
Percentage of royalty to be transferred, Range2 | 40% | |||
Senju Pharmaceutical | Arctic Vision License Agreement | ||||
Related Party Transactions | ||||
Upfront payments | $ 250,000 |
Stockholders' Equity - Restrict
Stockholders' Equity - Restricted stock units activity (Details) | 12 Months Ended |
Dec. 31, 2022 $ / shares shares | |
Number of RSUs | |
RSUs non-vested at beginning of period | shares | 41,778 |
Granted | shares | 193,304 |
Vested | shares | (55,319) |
Forfeited | shares | (6,963) |
RSUs non-vested at end of the period | shares | 172,800 |
Vested RSUs undelivered | shares | 32,900 |
Weighted Average Grant Date Value Per Share | |
RSUs non-vested January 1, 2021 | $ / shares | $ 3.59 |
Granted | $ / shares | 1.93 |
Vested | $ / shares | 3.37 |
Forfeited | $ / shares | 3.59 |
RSUs non-vested December 31, 2022 | $ / shares | 1.80 |
Vested RSUs undelivered September 30, 2022 | $ / shares | $ 3.59 |
Stockholders' Equity - Black Sc
Stockholders' Equity - Black Scholes option (Details) | 12 Months Ended | |
Dec. 31, 2022 | Dec. 31, 2021 | |
Stockholders' Equity | ||
Expected dividends | 0% | 0% |
Minimum | ||
Stockholders' Equity | ||
Expected term (years) | 6 months 29 days | 5 years 10 months 6 days |
Risk free interest rate | 0.76% | 0.45% |
Expected volatility | 82% | 92% |
Maximum | ||
Stockholders' Equity | ||
Expected term (years) | 10 years | 10 years |
Risk free interest rate | 3.80% | 1.58% |
Expected volatility | 90% | 94% |
Stockholders' Equity - Summary
Stockholders' Equity - Summary of option activity (Details) - USD ($) | 12 Months Ended | |
Dec. 31, 2022 | Dec. 31, 2021 | |
Stockholders' Equity | ||
Weighted Average Exercise Price, Granted | $ / Shares | $ 1.60 | $ 5.39 |
Stock Options | ||
Stockholders' Equity | ||
Number of Options, Outstanding | Shares | 4,377,398 | |
Number of Options, Granted | Shares | 1,181,310 | |
Number of Options, Forfeited | Shares | (178,155) | |
Number of Options, Outstanding | Shares | 5,380,553 | 4,377,398 |
Number of Options, Exercisable | Shares | 3,614,195 | |
Weighted Average Exercise Price, Outstanding | $ / Shares | $ 3.89 | |
Weighted Average Exercise Price, Granted | $ / Shares | 2.23 | |
Weighted Average Exercise Price, Forfeited | $ / Shares | 3.01 | |
Weighted Average Exercise Price, Outstanding | $ / Shares | 3.55 | $ 3.89 |
Weighted Average Exercise Price, Exercisable | $ / Shares | $ 3.79 | |
Weighted Average Remaining Life In Years, Outstanding | 7 years 2 months 12 days | |
Weighted Average Remaining Life In Years, Exercisable | 6 years 4 months 24 days | |
Aggregate Intrinsic Value, Outstanding | $ | $ 85,800 | |
Aggregate Intrinsic Value, Exercisable | $ 85,800 |
Stockholders' Equity - Summar_2
Stockholders' Equity - Summary of information related to stock options (Details) | 12 Months Ended |
Dec. 31, 2022 $ / shares shares | |
Stockholders' Equity | |
Options Outstanding, Outstanding Number of Options | 5,380,553 |
Options Exercisable, Weighted Average Remaining Life In Years | 6 years 4 months 24 days |
Options Exercisable, Exercisable Number of Options | 3,614,195 |
Exercise Price $1.00 - $1.99 | |
Stockholders' Equity | |
Options Outstanding, Outstanding Number of Options | 1,517,952 |
Options Exercisable, Weighted Average Remaining Life In Years | 3 years 9 months 18 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 | 1,010,018 |
Options Exercisable, Weighted Average Remaining Life In Years | 7 years 4 months 24 days |
Options Exercisable, Exercisable Number of Options | 847,485 |
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 | 1,202,539 |
Options Exercisable, Weighted Average Remaining Life In Years | 6 years 9 months 18 days |
Options Exercisable, Exercisable Number of Options | 804,840 |
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 | 383,500 |
Options Exercisable, Weighted Average Remaining Life In Years | 8 years 6 months |
Options Exercisable, Exercisable Number of Options | 193,623 |
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 | 100,805 |
Options Exercisable, Weighted Average Remaining Life In Years | 6 years |
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 | 1,000,821 |
Options Exercisable, Weighted Average Remaining Life In Years | 7 years |
Options Exercisable, Exercisable Number of Options | 765,055 |
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 3 months 18 days |
Options Exercisable, Exercisable Number of Options | 164,918 |
Stockholders' Equity - Warrants
Stockholders' Equity - Warrants Activity (Details) | 12 Months Ended |
Dec. 31, 2022 $ / shares shares | |
Number of Warrants | |
Outstanding at beginning balance | shares | 1,217,715 |
Granted | shares | 6,740,260 |
Exercised | shares | 1,870,130 |
Outstanding at ending balance | shares | 6,087,845 |
Exercisable Number of warrants | shares | 6,087,845 |
Weighted Average Exercise Price | |
Outstanding at beginning balance | $ / shares | $ 2.69 |
Granted | $ / shares | 2.56 |
Exercised | $ / shares | 0.01 |
Outstanding at ending balance | $ / shares | 3.37 |
Exercisable | $ / shares | $ 3.37 |
Weighted Average Remaining Life, Outstanding | 4 years 3 months 18 days |
Weighted Average Remaining Life, Exercisable | 4 years 3 months 18 days |
Stockholders' Equity - Related
Stockholders' Equity - Related to warrants (Details) - USD ($) | 12 Months Ended | |
Dec. 31, 2022 | Dec. 31, 2021 | |
Stockholders' Equity | ||
Exercise price | $ 0.01 | |
Outstanding Number of Warrants | 6,087,845 | 1,217,715 |
Weighted Average Remaining Life, Exercisable | 4 years 3 months 18 days | |
Exercisable Number of Warrants | 6,087,845 | |
Number of warrants exercised | (1,870,130) | |
Proceeds from exercise of warrants | $ 18,701 | $ 2,124,904 |
Warrants at exercise price of $2.4696 | ||
Stockholders' Equity | ||
Exercise price | $ 2.4696 | |
Outstanding Number of Warrants | 909,451 | |
Weighted Average Remaining Life, Exercisable | 2 years 2 months 12 days | |
Exercisable Number of Warrants | 909,451 | |
Warrants at exercise price of $2.7240 | ||
Stockholders' Equity | ||
Exercise price | $ 2.7240 | |
Outstanding Number of Warrants | 216,380 | |
Weighted Average Remaining Life, Exercisable | 2 years 2 months 12 days | |
Exercisable Number of Warrants | 216,380 | |
Warrants at exercise price of $4.7600 | ||
Stockholders' Equity | ||
Exercise price | $ 4.7600 | |
Outstanding Number of Warrants | 91,884 | |
Weighted Average Remaining Life, Exercisable | 8 years 3 months 18 days | |
Exercisable Number of Warrants | 91,884 | |
Warrants at exercise price of $3.5400 | ||
Stockholders' Equity | ||
Exercise price | $ 3.5400 | |
Outstanding Number of Warrants | 4,870,130 | |
Weighted Average Remaining Life, Exercisable | 4 years 8 months 12 days | |
Exercisable Number of Warrants | 4,870,130 |
Stockholders' Equity - Addition
Stockholders' Equity - Additional Information (Details) - USD ($) | 12 Months Ended | |||||||
Mar. 10, 2023 | Jan. 01, 2023 | Mar. 03, 2022 | Dec. 14, 2021 | May 14, 2021 | Apr. 07, 2020 | Dec. 31, 2022 | Dec. 31, 2021 | |
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 | ||||||
Number of warrants issued | 1,870,130 | |||||||
Share-based compensation | $ 3,765,364 | $ 2,886,102 | ||||||
Unrecognized stock - based compensation expense | $ 3,621,440 | |||||||
Weighted average period of recognition | 1 year 6 months | |||||||
Weighted average estimated grant date fair value | $ 1.60 | $ 5.39 | ||||||
Proceeds from Stock Options Exercised | $ 0 | $ 203,126 | ||||||
Stock-based compensation | $ 3,765,364 | 2,886,102 | ||||||
Granted | 193,304 | |||||||
Exercise price of warrants | $ 0.01 | |||||||
Securities purchase agreement | ||||||||
Stockholders' Equity | ||||||||
Net proceeds (in shares) | 250,000 | 3,000,000 | ||||||
Share price | $ 3.08 | |||||||
Research and Development Expense. | ||||||||
Stockholders' Equity | ||||||||
Share-based compensation | 1,612,942 | |||||||
Stock-based compensation | $ 1,809,305 | |||||||
General and Administrative Expense | ||||||||
Stockholders' Equity | ||||||||
Share-based compensation | $ 1,273,160 | |||||||
Stock-based compensation | $ 1,956,059 | |||||||
Restricted stock units | ||||||||
Stockholders' Equity | ||||||||
Weighted average period of recognition | 6 months | |||||||
Unrecognized stock-based compensation expense | $ 149,158 | |||||||
Granted | 193,304 | 49,964 | ||||||
Grant date fair value | $ 373,000 | $ 181,200 | ||||||
Common Stock | ||||||||
Stockholders' Equity | ||||||||
Stock-based compensation | $ 0 | $ 0 | ||||||
Share-based Compensation Arrangement by Share-based Payment Award, Options, Exercises in Period | 121,261 | |||||||
May 2021 Sales Agreement | ||||||||
Stockholders' Equity | ||||||||
Proceeds from issuance of common stock | $ 12,800,000 | |||||||
Net proceeds (in shares) | 2,435,604 | |||||||
Net proceeds | $ 12,400,000 | |||||||
May 2021 Sales Agreement | Common Stock | ||||||||
Stockholders' Equity | ||||||||
Percentage on gross sale | 3% | |||||||
Aggregate offering price | $ 30,000,000 | |||||||
December 2021 Sales Agreement | ||||||||
Stockholders' Equity | ||||||||
Proceeds from issuance of common stock | $ 50,000,000 | |||||||
Net proceeds (in shares) | 1,299,947 | 2,716,061 | ||||||
Gross Proceeds Of Stock Value Issued During Period | $ 5,400,000 | |||||||
Net Proceeds From Issuance Of Common Stock | $ 5,300,000 | |||||||
Net proceeds | $ 3,500,000 | |||||||
December 2021 Sales Agreement | Common Stock | ||||||||
Stockholders' Equity | ||||||||
Percentage on gross sale | 3% | |||||||
Omnibus Stock Incentive Plan 2018 | ||||||||
Stockholders' Equity | ||||||||
Number of shares of common stock reserved for further issuance | 1,011,245 | |||||||
Cash fee paid | $ 150,000 | |||||||
Share-based Compensation Arrangement by Share-based Payment Award, Award Vesting Period | 12 months | |||||||
Equity Incentive Plan | ||||||||
Stockholders' Equity | ||||||||
Number of shares of common stock reserved for further issuance | 5,700,000 | |||||||
Pre-funded warrants | Securities purchase agreement | ||||||||
Stockholders' Equity | ||||||||
Decrease in exercise price | $ 0.01 | |||||||
Number of common shares | 1,870,130 | |||||||
Pre-funded warrants | IPO | ||||||||
Stockholders' Equity | ||||||||
Share price | $ 3.07 | |||||||
Investor warrants | Securities purchase agreement | ||||||||
Stockholders' Equity | ||||||||
Shares Issued, Price Per Share | $ 3.54 | |||||||
Investor warrants | IPO | ||||||||
Stockholders' Equity | ||||||||
Number of warrants issued | 4,870,130 | |||||||
March 2022 offering | ||||||||
Stockholders' Equity | ||||||||
Aggregate issuance costs of pre-funded warrants and investor warrants | $ 89,031 | |||||||
March 2022 offering | Securities purchase agreement | ||||||||
Stockholders' Equity | ||||||||
Proceeds from issuance of common stock | $ 15,000,000 |
Employee Benefit Plans (Details
Employee Benefit Plans (Details) - USD ($) | 1 Months Ended | 12 Months Ended | |
Apr. 30, 2019 | Dec. 31, 2022 | Dec. 31, 2021 | |
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 | $ 208,006 | $ 175,352 |
Subsequent Event - December 202
Subsequent Event - December 2021 Sales Agreement (Details) $ in Millions | Jan. 01, 2023 USD ($) |
December 2021 Sales Agreement [Member] | |
Subsequent Event [Line Items] | |
Net proceeds | $ 3.5 |
Subsequent Event - Stock Option
Subsequent Event - Stock Options (Details) - Subsequent Event - Employee Stock Option [Member] | 1 Months Ended |
Jan. 31, 2023 $ / shares shares | |
Subsequent Event [Line Items] | |
Stock Issued During Period, Shares, New Issues | shares | 421,735 |
Share Price | $ / shares | $ 2.16 |
Subsequent Events (Details)
Subsequent Events (Details) - Subsequent Events | Jan. 01, 2023 USD ($) shares |
Subsequent Events | |
Option to purchase number of shares of common stock | shares | 120,000 |
Employment Agreement | |
Subsequent Events | |
Annual salary | $ | $ 345,000 |
Cash bonus (in percentage) | 30% |
Subsequent Events - Securities
Subsequent Events - Securities Purchase Agreement (Details) - USD ($) $ / shares in Units, $ in Millions | Mar. 10, 2023 | Mar. 03, 2022 | Dec. 31, 2022 |
Subsequent Event [Line Items] | |||
Number of warrants issued | 1,870,130 | ||
Securities Purchase Agreement [Member] | |||
Subsequent Event [Line Items] | |||
Stock issued during the period | 250,000 | 3,000,000 | |
Share price | $ 3.08 | ||
Securities Purchase Agreement [Member] | Equity Offering March 2022 [Member] | |||
Subsequent Event [Line Items] | |||
Proceeds from issuance of common stock | $ 15 | ||
Securities Purchase Agreement [Member] | Pre-funded Warrants [Member] | |||
Subsequent Event [Line Items] | |||
Decrease in exercise price | $ 0.01 |
Subsequent Event - Restricted S
Subsequent Event - Restricted Stock Units (Details) - shares | Dec. 31, 2022 | Dec. 31, 2021 |
Subsequent Events | ||
RSUs non-vested of an aggregate amount | 172,800 | 41,778 |
Subsequent Event (Details)
Subsequent Event (Details) - USD ($) | 12 Months Ended | |
Dec. 31, 2022 | Dec. 31, 2021 | |
Number of warrants issued | 1,870,130 | |
Proceeds from exercise of stock warrants | $ 18,701 | $ 2,124,904 |
Exercise price of warrants | $ 0.01 | |
Stock Option [Member] | ||
Number of Options, Granted | Shares | 1,181,310 | |
Term of the options | 7 years 2 months 12 days |