Document and Entity Information
Document and Entity Information - shares | 9 Months Ended | |
Sep. 30, 2022 | Nov. 10, 2022 | |
Document and Entity Information | ||
Document Type | 10-Q | |
Document Quarterly Report | true | |
Document Period End Date | Sep. 30, 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, 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 | |
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 | |
Trading Symbol | EYEN | |
Entity Shell Company | false | |
Title of 12(b) Security | Common Stock, $0.0001 Par Value | |
Security Exchange Name | NASDAQ | |
Entity Common Stock, Shares Outstanding | 36,112,987 | |
Entity Central Index Key | 0001682639 | |
Current Fiscal Year End Date | --12-31 | |
Document Fiscal Year Focus | 2022 | |
Document Fiscal Period Focus | Q3 | |
Amendment Flag | false |
Condensed Balance Sheets
Condensed Balance Sheets - USD ($) | Sep. 30, 2022 | Dec. 31, 2021 |
Current Assets: | ||
Cash and cash equivalents | $ 17,398,605 | $ 19,461,850 |
Restricted cash | 7,875,000 | 7,875,000 |
Deferred clinical supply costs | 1,871,096 | |
License fee and expense reimbursements receivable | 809,430 | 1,805,065 |
Prepaid expenses and other current assets | 1,463,020 | 721,438 |
Total Current Assets | 29,417,151 | 29,863,353 |
Property and equipment, net | 1,342,657 | 1,271,225 |
Security deposits | 200,153 | 132,539 |
Equipment deposits | 445,530 | 391,941 |
Total Assets | 31,405,491 | 31,659,058 |
Current Liabilities: | ||
Accounts payable | 1,104,959 | 1,614,104 |
Accrued compensation | 1,268,009 | 1,543,618 |
Accrued expenses and other current liabilities | 1,384,803 | 845,719 |
Deferred rent - current portion | 28,999 | 18,685 |
Notes payable | 7,229,013 | 7,150,368 |
Total Current Liabilities | 11,015,783 | 11,172,494 |
Deferred rent - non-current portion | 60,540 | 19,949 |
Total Liabilities | 11,076,323 | 11,192,443 |
Commitments and contingencies (Note 7) | ||
Stockholders' Equity: | ||
Preferred stock, $0.0001 par value, 6,000,000 shares authorized; 0 shares issued and outstanding as of September 30, 2022 and December 31, 2021 | 0 | 0 |
Common stock, $0.0001 par value, 90,000,000 shares authorized; 35,525,689 and 28,426,616 shares issued and outstanding as of September 30, 2022 and December 31, 2021, respectively | 3,553 | 2,844 |
Additional paid-in capital | 132,432,682 | 110,683,077 |
Accumulated deficit | (112,107,067) | (90,219,306) |
Total Stockholders' Equity | 20,329,168 | 20,466,615 |
Total Liabilities and Stockholders' Equity | $ 31,405,491 | $ 31,659,058 |
Condensed Balance Sheets (Paren
Condensed Balance Sheets (Parenthetical) - $ / shares | Sep. 30, 2022 | Dec. 31, 2021 |
Condensed Balance Sheets | ||
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 | 35,525,689 | 28,426,616 |
Common stock, shares outstanding | 35,525,689 | 28,426,616 |
Condensed Statements of Operati
Condensed Statements of Operations - USD ($) | 3 Months Ended | 9 Months Ended | ||
Sep. 30, 2022 | Sep. 30, 2021 | Sep. 30, 2022 | Sep. 30, 2021 | |
Operating Income | ||||
Revenue | $ 0 | $ 0 | $ 0 | $ 4,000,000 |
Cost of revenue | 0 | 0 | 0 | (1,600,000) |
Gross Profit | 0 | 0 | 0 | 2,400,000 |
Operating Expenses: | ||||
Research and development | 3,876,876 | 3,552,068 | 11,176,326 | 11,559,364 |
General and administrative | 3,353,352 | 2,372,999 | 10,362,907 | 6,914,481 |
Total Operating Expenses | 7,230,228 | 5,925,067 | 21,539,233 | 18,473,845 |
Loss From Operations | (7,230,228) | (5,925,067) | (21,539,233) | (16,073,845) |
Other Income (Expense): | ||||
Extinguishment of PPP 7(a) loan | 463,353 | 0 | 463,353 | |
Other income, net | 70,277 | 11,728 | 96,580 | 48,880 |
Interest expense | (177,138) | (119,212) | (475,811) | (202,407) |
Interest income | 28,093 | 600 | 30,703 | 2,354 |
Net Loss | $ (7,308,996) | $ (5,568,598) | $ (21,887,761) | $ (15,761,665) |
Net Loss Per Share | ||||
Net Loss Per Share - Basic | $ (0.21) | $ (0.21) | $ (0.67) | $ (0.61) |
Net Loss Per Share - Diluted | $ (0.21) | $ (0.21) | $ (0.67) | $ (0.61) |
Weighted Average Number of Common Shares Outstanding | ||||
Weighted Average Number of Common Shares Outstanding - Basic | 34,631,774 | 26,053,532 | 32,778,551 | 25,773,098 |
Weighted Average Number of Common Shares Outstanding - Diluted | 34,631,774 | 26,053,532 | 32,778,551 | 25,773,098 |
Condensed Statements of Changes
Condensed Statements of Changes in Stockholders' Equity - USD ($) | Common Stock | Additional Paid-In Capital | Accumulated Deficit | Total | |
Balance at the beginning at Dec. 31, 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 | ||||
Exercise of stock warrants | $ 65 | 1,530,925 | 0 | 1,530,990 | |
Exercise of stock warrants (in shares) | 644,992 | ||||
Stock-based compensation | $ 0 | 656,913 | 0 | 656,913 | |
Net loss | 0 | 0 | (5,351,667) | (5,351,667) | |
Balance at the end at Mar. 31, 2021 | $ 2,563 | 94,930,144 | (82,792,586) | 12,140,121 | |
Balance at the end (in shares) at Mar. 31, 2021 | 25,623,577 | ||||
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 | ||||
Net loss | (15,761,665) | ||||
Balance at the end at Sep. 30, 2021 | $ 2,597 | 97,446,125 | (93,202,584) | 4,246,138 | |
Balance at the end (in shares) at Sep. 30, 2021 | 25,963,185 | ||||
Balance at the beginning at Mar. 31, 2021 | $ 2,563 | 94,930,144 | (82,792,586) | 12,140,121 | |
Balance at the beginning (in shares) at Mar. 31, 2021 | 25,623,577 | ||||
Exercise of stock warrants | $ 23 | 572,978 | 0 | 573,001 | |
Exercise of stock warrants (in shares) | 232,022 | ||||
Exercise of stock options | $ 9 | 130,081 | 0 | 130,090 | |
Exercise of stock options (in shares) | 91,047 | ||||
Issuance of SVB warrants | [1] | $ 0 | 351,390 | 0 | 351,390 |
Stock-based compensation | 0 | 637,355 | 0 | 637,355 | |
Net loss | 0 | 0 | (4,841,400) | (4,841,400) | |
Balance at the end at Jun. 30, 2021 | $ 2,595 | 96,621,948 | (87,633,986) | 8,990,557 | |
Balance at the end (in shares) at Jun. 30, 2021 | 25,946,646 | ||||
Exercise of stock options | $ 2 | 46,710 | 0 | 46,712 | |
Exercise of stock options (in shares) | 16,539 | ||||
Stock-based compensation | $ 0 | 777,467 | 0 | 777,467 | |
Net loss | 0 | 0 | (5,568,598) | (5,568,598) | |
Balance at the end at Sep. 30, 2021 | $ 2,597 | 97,446,125 | (93,202,584) | 4,246,138 | |
Balance at the end (in shares) at Sep. 30, 2021 | 25,963,185 | ||||
Balance at the beginning at Dec. 31, 2021 | $ 2,844 | 110,683,077 | (90,219,306) | 20,466,615 | |
Balance at the beginning (in shares) at Dec. 31, 2021 | 28,426,616 | ||||
Issuance of common stock and warrants in registered direct offering | [2] | $ 300 | 14,897,608 | 14,897,908 | |
Issuance of common stock and warrants in registered direct offering (in shares) | [2] | 3,000,000 | |||
Issuance of common stock in At the Market offering | [3] | $ 25 | 860,340 | 0 | 860,365 |
Issuance of common stock in At the Market offering (in shares) | [3] | 252,449 | |||
Stock-based compensation | $ 0 | 908,987 | 0 | 908,987 | |
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 | (7,339,665) | (7,339,665) | |
Balance at the end at Mar. 31, 2022 | $ 3,171 | 127,350,010 | (97,558,971) | 29,794,210 | |
Balance at the end (in shares) at Mar. 31, 2022 | 31,698,424 | ||||
Balance at the beginning at Dec. 31, 2021 | $ 2,844 | 110,683,077 | (90,219,306) | 20,466,615 | |
Balance at the beginning (in shares) at Dec. 31, 2021 | 28,426,616 | ||||
Net loss | (21,887,761) | ||||
Balance at the end at Sep. 30, 2022 | $ 3,553 | 132,432,682 | (112,107,067) | 20,329,168 | |
Balance at the end (in shares) at Sep. 30, 2022 | 35,525,689 | ||||
Balance at the beginning at Mar. 31, 2022 | $ 3,171 | 127,350,010 | (97,558,971) | 29,794,210 | |
Balance at the beginning (in shares) at Mar. 31, 2022 | 31,698,424 | ||||
Exercise of stock warrants | $ 187 | 18,514 | 0 | 18,701 | |
Exercise of stock warrants (in shares) | 1,870,130 | ||||
Stock-based compensation | $ 0 | 1,036,926 | 0 | 1,036,926 | |
Issuance of common stock related to vested restricted stock units | $ 5 | (5) | 0 | 0 | |
Issuance of common stock related to vested restricted stock units (in shares) | 54,499 | ||||
Net loss | $ 0 | 0 | (7,239,100) | (7,239,100) | |
Balance at the end at Jun. 30, 2022 | $ 3,363 | 128,405,445 | (104,798,071) | 23,610,737 | |
Balance at the end (in shares) at Jun. 30, 2022 | 33,623,053 | ||||
Issuance of common stock in At the Market offering | [4] | $ 188 | 3,098,506 | 3,098,694 | |
Issuance of common stock in At the Market offering (in shares) | [4] | 1,876,314 | |||
Stock-based compensation | $ 0 | 928,733 | 0 | 928,733 | |
Issuance of common stock related to vested restricted stock units | $ 2 | (2) | |||
Issuance of common stock related to vested restricted stock units (in shares) | 26,322 | ||||
Net loss | $ 0 | 0 | (7,308,996) | (7,308,996) | |
Balance at the end at Sep. 30, 2022 | $ 3,553 | $ 132,432,682 | $ (112,107,067) | $ 20,329,168 | |
Balance at the end (in shares) at Sep. 30, 2022 | 35,525,689 | ||||
[1] Allocated fair value of warrants of $354,539 , less allocated issuance costs of $3,149 . Includes gross proceeds of $14,981,299 less total issuance costs of $83,391 . Includes gross proceeds of $886,974 , less total issuance costs of $26,609 . Includes gross proceeds of $3,194,530 , less total issuance costs of $95,836 . |
Condensed Statements of Chang_2
Condensed Statements of Changes in Stockholders' Equity (Parenthetical) - USD ($) | 3 Months Ended | ||
Sep. 30, 2022 | Mar. 31, 2022 | Jun. 30, 2021 | |
Adjustments to additional paid in capital upon stock issuance costs | $ 3,149 | ||
Fair value of warrants | $ 354,539 | ||
Common Stock One | |||
Proceeds of stock issued during period gross | $ 14,981,299 | ||
Adjustments to additional paid in capital upon stock issuance costs | 83,391 | ||
Common Stock Two | |||
Proceeds of stock issued during period gross | 886,974 | ||
Adjustments to additional paid in capital upon stock issuance costs | $ 26,609 | ||
Common Stock Three | |||
Proceeds of stock issued during period gross | $ 3,194,530 | ||
Adjustments to additional paid in capital upon stock issuance costs | $ 95,836 |
Condensed Statements of Cash Fl
Condensed Statements of Cash Flows - USD ($) | 9 Months Ended | ||
Sep. 30, 2022 | Sep. 30, 2021 | ||
Cash Flows From Operating Activities | |||
Net loss | $ (21,887,761) | $ (15,761,665) | |
Adjustments to reconcile net loss to net cash used in operating activities: | |||
Stock-based compensation | 2,874,646 | 2,071,735 | |
Depreciation of property and equipment | 228,898 | 148,245 | |
Amortization of debt discount | 78,645 | 41,944 | |
Write-off of property and equipment | 209,040 | 0 | |
Extinguishment of PPP 7(a) Loan | 0 | (463,353) | |
Changes in operating assets and liabilities: | |||
Prepaid expenses and other current assets | (66,250) | 35,549 | |
License fee and expense reimbursements receivables | 995,635 | 2,005,859 | |
Deferred clinical supply costs | (1,871,096) | 0 | |
Deferred license costs | 0 | 1,600,000 | |
Security deposits | (67,614) | 0 | |
Accounts payable | (509,145) | 223,068 | |
Accrued compensation | (275,609) | 33,564 | |
Accrued expenses and other current liabilities | 539,084 | (928,356) | |
Deferred license fee | 0 | (4,000,000) | |
Deferred rent | 50,905 | (4,397) | |
Net Cash Used In Operating Activities | (19,700,622) | (14,997,807) | |
Cash Flows From Investing Activities | |||
Purchases of property and equipment | (509,370) | (1,165,066) | |
Vendor deposits for property and equipment | (53,589) | 0 | |
Net Cash Used In Investing Activities | (562,959) | (1,165,066) | |
Cash Flows From Financing Activities | |||
Proceeds from sale of common stock and warrants in registered direct offering | [1] | 14,981,299 | 0 |
Net issuance of common stock in At the Market Offering | [2] | 3,959,059 | 0 |
Proceeds from exercise of stock warrants | 18,701 | 2,103,991 | |
Proceeds from SVB loan | 0 | 7,500,000 | |
Repayments of notes payable | (675,332) | (547,259) | |
Payment of offering issuance costs | (83,391) | 0 | |
Payment of loan issuance costs | 0 | (66,618) | |
Proceeds from exercise of stock options | 0 | 176,802 | |
Net Cash Provided By Financing Activities | 18,200,336 | 9,166,916 | |
Net Decrease in Cash and Cash Equivalents and Restricted Cash | (2,063,245) | (6,995,957) | |
Cash, cash equivalents and restricted cash - Beginning of Period | 27,336,850 | 28,371,828 | |
Cash, cash equivalents and restricted cash - End of Period | 25,273,605 | 21,375,871 | |
Cash,cash equivalents and restricted cash consisted of the following: | |||
Cash and cash equivalents | 17,398,605 | 13,500,871 | |
Restricted cash | 7,875,000 | 7,875,000 | |
Total | 25,273,605 | 21,375,871 | |
Supplemental Disclosure of Cash Flow Information: | |||
Interest | 315,550 | 131,839 | |
Supplemental Disclosure of Non-Cash Investing and Financing Activities | |||
Purchase of insurance premium financed by note payable | 675,332 | 705,360 | |
Issuance of SVB stock warrants | $ 351,390 | ||
Issuance of common stock related to vested restricted stock units | $ 9 | ||
[1]Includes gross proceeds of $14,981,299, of which $5,741,299 is pre-funded warrants.[2]Includes gross proceeds of $4,081,504, less total issuance costs of $122,445 |
Condensed Statements of Cash _2
Condensed Statements of Cash Flows (Parenthetical) | 9 Months Ended |
Sep. 30, 2022 USD ($) | |
Common Stock One | |
Proceeds of stock issued during period gross | $ 14,981,299 |
Common Stock One | Pre-Funder Warrants | |
Proceeds of stock issued during period gross | 5,741,299 |
Common Stock Two | |
Proceeds of stock issued during period gross | 4,081,504 |
Payments of debt issuance costs | $ 122,445 |
Business Organization, Nature o
Business Organization, Nature of Operations and Basis of Presentation | 9 Months Ended |
Sep. 30, 2022 | |
Business Organization, Nature of Operations and Basis of Presentation | |
Business Organization, Nature of Operations and Basis of Presentation | Note 1 – Business Organization, Nature of Operations and Basis of Presentation Eyenovia, Inc. (“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. The Company aims to achieve precision in ophthalmic drug delivery of novel and existing ophthalmic pharmaceutical agents. The precise delivery of a low-volume columnar spray by the Optejet® device also minimizes contamination with a non-protruding nozzle and self-closing shutter. The Company believes that this technology could ultimately replace eye droppers by advancing drug delivery beyond the limitations of patient coordination, drug overexposure, gravity, contamination potential, and discomfort towards a more precise, comfortable, and successful drug administration for improved patient care. The ergonomic and functional design of the Optejet® delivers microdroplets horizontally faster than the blink reflex to minimize instillation discomfort and overflow spillage, providing a more comfortable experience. In the clinic, the Optejet® has demonstrated that its targeted delivery achieves a significantly high rate of successful administration of 98% upon first attempt compared to the established rate reported with traditional eye drops of ~ 50%. The diagnostics and therapeutics in the Company’s pipeline have been tested in randomized controlled trials and demonstrated significant results in improving the benefit to risk profile for drug delivery. For example, the Company’s deliberately designed technology provides a 75% reduction in ocular drug and preservative exposure to significantly improve the therapeutic index in drugs used for presbyopia, mydriasis and intraocular pressure (“IOP”) lowering through eight clinical trials. Eyedrops expose the ocular surface to approximately 300% more medication and preservatives that can lead to unintended effects and induce collateral tissue damage. Drug delivery via the Optejet device reduces ocular exposure to preservatives comparable to that of non-preserved formulations demonstrating potentially less surface damage from ocular stress. 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 (“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 (“CDER”) is designated as the lead center with primary jurisdictional oversight. Accordingly, the product candidates are submitted to the FDA CDER for premarket review and approval under new drug applications (“NDAs”). The accompanying unaudited condensed financial statements have been prepared in accordance with accounting principles generally accepted in the United States of America (“U.S. GAAP”) for interim financial information and with the instructions to Form 10-Q and Article 8 of Regulation S-X. Accordingly, they do not include all of the information and disclosures required by U.S. GAAP for complete financial statements. In the opinion of management, such statements include all adjustments (consisting only of normal recurring items) which are considered necessary for a fair presentation of the condensed financial statements of the Company as of September 30, 2022 and for the three and nine months ended September 30, 2022 and 2021. The results of operations for the nine months ended September 30, 2022 are not necessarily indicative of the operating results for the full year ending December 31, 2022 or any other period. These unaudited condensed financial statements should be read in conjunction with the audited financial statements and related disclosures of the Company as of December 31, 2021 and for the year then ended, which were included in the Company’s Annual Report on Form 10-K filed with the Securities and Exchange Commission (“SEC”) on March 30, 2022. |
Summary of Significant Accounti
Summary of Significant Accounting Policies | 9 Months Ended |
Sep. 30, 2022 | |
Summary of Significant Accounting Policies | |
Summary of Significant Accounting Policies | Note 2 – Summary of Significant Accounting Policies Since the date of the Company’s Annual Report on Form 10-K for the year ended December 31, 2021, there have been no material changes to the Company’s significant accounting policies. Liquidity and Going Concern As of September 30, 2022, the Company had unrestricted cash of approximately $17.4 million and an accumulated deficit of approximately $112.1 million. For the nine months ended September 30, 2022 and 2021, the Company incurred net losses of approximately $21.9 million and $15.8 million, respectively, and used cash in operations of approximately $19.7 million and $15.0 million, respectively. Subsequent to September 30, 2022, the Company received approximately $1.3 million in net proceeds from the sale of 587,298 shares of common stock pursuant to the Company’s At-the-Market Offering program with SVB Leerink. Also subsequent to September 30, 2022, the Company used its $7.9 million of restricted cash and $0.1 million of unrestricted cash in order to repay the Loan and Security Agreement, dated May 7, 2021 (the “SVB Loan”) with Silicon Valley Bank (“SVB”), including $7.5 million of principal, a final payment of $0.4 million and a prepayment fee of $0.1 million. The Company does not have recurring revenue and has not yet achieved profitability. The Company expects to continue to incur cash outflows from operations. The Company expects that its research and development and general and administrative expenses will continue to increase and, as a result, it will eventually need to generate significant product revenues to achieve profitability. These circumstances raise substantial doubt about the Company’s ability to continue as a going concern for at least one year from the date that these financial statements are issued. Implementation of the Company’s plans and its ability to continue as a going concern will depend upon the Company’s ability to commercialize its products and raise further capital, through licensing transactions, 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 secure additional capital, it may be required to curtail its research and development initiatives and take additional measures to reduce general and administrative and sales and marketing costs in order to conserve its cash. Cash and Cash Equivalents 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, such as the collateralized money market account pursuant to the SVB Loan, as amended on September 29, 2021 by the First Amendment to the Loan and Security Agreement (the “First Amendment”). See Note 6 - Notes Payable. In connection with the First Amendment, the Company pledged to establish and maintain a collateralized money market account in the amount of $7,875,000. Subsequent to September 30, 2022, the Company used this entire collateralized money market account plus $0.1 million of unrestricted cash in order to repay the SVB Loan, including $7.5 million of principal, a final payment of $0.4 million and a prepayment fee of $0.1 million. The Company has cash deposits in a financial institution which, at times, may be in excess of Federal Deposit Insurance Corporation (“FDIC”) insurance limits. The Company has not experienced losses in such accounts and periodically evaluates the creditworthiness of its financial institutions. As of September 30, 2022 and December 31, 2021, the Company had cash balances in excess of FDIC insurance limits of $24,773,605 and $26,836,850, respectively. Net Loss Per Common Share Basic net loss per common share is computed by dividing net loss by the weighted average number of common shares outstanding during the period plus fully vested shares that are subject to issuance for little or no monetary consideration. Diluted earnings per share reflects the potential dilution that could occur if securities or other instruments to issue common stock were exercised or converted into common stock. The following securities are excluded from the calculation of weighted average diluted common shares because their inclusion would have been anti-dilutive: September 30, 2022 2021 Options 5,484,687 3,410,540 Warrants 6,087,845 2,095,993 Restricted stock units 172,800 105,306 Total potentially dilutive shares 11,745,332 5,611,839 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 Accounting Standards Codification (“ASC”) Topic 808, “Collaborative Arrangements” (“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” (“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, we recognize revenue when our customers obtain control of promised goods or services, in an amount that reflects the consideration which we expect to receive in exchange for those goods or services. To determine revenue recognition for arrangements that we determine are within the scope of ASC 606, we perform 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. In addition, 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 whether these options provide a material right to the customer and if so, they are considered performance obligations. For upfront license fees, the Company must consider how many performance obligations are in the contract and, if more than one, how to allocate the fee to those performance obligations upon satisfaction of the performance obligation(s). 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. During 2020, the Company entered into a license agreement (the “Arctic Vision License Agreement”) with Arctic Vision (Hong Kong) Limited (“Arctic Vision”) and a license agreement (the “Bausch License Agreement”) with Bausch + Lomb, Inc. (“Bausch + Lomb”). Each license has three revenue components: 1) an upfront license fee; 2) milestone payments and 3) royalty payments. Deferred License Fee The Company enters into license agreements which provide for the receipt of non-refundable, upfront licensing payments. These payments are recorded as deferred license fees and will be earned and recognized as revenue upon the satisfaction of performance obligations. See Note 7 – Commitments and Contingencies for additional details. 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. 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. Recently Adopted Accounting Standards On May 3, 2021, the Financial Accounting Standards Board (the “FASB”) issued Accounting Standards Update (“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. Soon To Be Adopted Accounting Standards In February 2016, the FASB issued ASU 2016-02 “Leases (Topic 842)” (“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 plans to adopt ASU 2016-02 on December 31, 2022 and expects that the adoption of this ASU will have 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 $1.3 million and $1.4 million, respectively. |
Prepaid Expenses and Other Curr
Prepaid Expenses and Other Current Assets | 9 Months Ended |
Sep. 30, 2022 | |
Prepaid Expenses and Other Current Assets | |
Prepaid Expenses and Other Current Assets | Note 3 – Prepaid Expenses and Other Current Assets As of September 30, 2022 and December 31, 2021, prepaid expenses and other current assets consisted of the following: September 30, December 31, 2022 2021 Payroll tax receivable 621,063 343,785 Prepaid insurance expenses 455,150 171,370 Prepaid general and administrative expenses 185,845 71,375 Prepaid conference expenses 100,803 12,586 Prepaid patent expenses 49,183 32,797 Other 32,226 4,525 Prepaid security deposits 18,750 18,750 Prepaid board of directors fees — 66,250 Total prepaid expenses and other current assets $ 1,463,020 $ 721,438 |
Accrued Compensation
Accrued Compensation | 9 Months Ended |
Sep. 30, 2022 | |
Accrued Compensation | |
Accrued Compensation | Note 4 – Accrued Compensation As of September 30, 2022 and December 31, 2021, accrued compensation consisted of the following: September 30, December 31, 2022 2021 Accrued bonus expenses $ 971,159 $ 1,245,795 Accrued payroll expenses 296,850 297,823 Total accrued compensation $ 1,268,009 $ 1,543,618 |
Accrued Expenses and Other Curr
Accrued Expenses and Other Current Liabilities | 9 Months Ended |
Sep. 30, 2022 | |
Accrued Expenses and Other Current Liabilities | |
Accrued Expenses and Other Current Liabilities | Note 5 – Accrued Expenses and Other Current Liabilities As of September 30, 2022 and December 31, 2021, accrued expenses and other current liabilities consisted of the following: September 30, December 31, 2022 2021 Accrued research and development expenses $ 711,710 $ 436,840 Accrued consulting and professional services 386,712 250,000 Accrued interest 152,969 94,792 Credit card payable 58,799 20,000 Accrued franchise tax 39,300 1,680 Other 29,647 42,407 Accrued travel and entertainment expenses 5,666 — Total accrued expenses and other current liabilities $ 1,384,803 $ 845,719 |
Notes Payable
Notes Payable | 9 Months Ended |
Sep. 30, 2022 | |
Notes Payable | |
Notes Payable | Note 6 – Notes Payable As of September 30, 2022 and December 31, 2021, notes payable consisted of the following: September 30, 2022 December 31, 2021 Notes Payable Debt Discount Net Notes Payable Debt Discount Net Silicon Valley Bank loan $ 7,500,000 $ (270,987) $ 7,229,013 $ 7,500,000 $ (349,632) $ 7,150,368 On February 24, 2022, the Company issued a note payable for the purchase of directors and officers liability insurance policy (the “D&O Loan”). The D&O Loan had an aggregate principal balance of $675,332 and was payable in six During the three months ended September 30, 2022, the Company recorded interest expense of $177,138, of which $176,215 is related to the SVB Loan (including amortization of debt discount of $26,214) and $923 is related to the D&O Loan. During the nine months ended September 30, 2022, the Company recorded interest expense of $475,811, of which $469,376 is related to the SVB Loan (including amortization of debt discount of $78,645) and $6,435 is related to the D&O Loan. SVB Loan Amendment On May 6, 2022, the Company and SVB agreed to amend the terms of the SVB Loan dated May 7, 2021. Pursuant to the amendment, the repayment term of the SVB Loan is reduced to 24 consecutive calendar months and the date that the first payment is due by the Company is extended to June 1, 2023. The amendment did not result in a 10% change in the net present value of the SVB Loan cash flows and, accordingly, the amendment was accounted for as a modification (a continuation of the original loan). The SVB Loan was repaid in full in November 2022. See Note 10 – Subsequent Events. |
Commitments and Contingencies
Commitments and Contingencies | 9 Months Ended |
Sep. 30, 2022 | |
Commitments and Contingencies | |
Commitments and Contingencies | Note 7 – Commitments and Contingencies Employment Agreements On February 14, 2022, the Compensation Committee of the Board of Directors of the Company (the “Board”) approved amendments to the Employment Agreements with its executive officers (the “Employment Agreement Addendums”). 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 “Involuntary 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 (estimated at approximately $1,517,000 in the aggregate as of the date of the Employment Agreement Addendums), 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, effective August 1, 2022, with Dr. Tsontcho Ianchulev 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 (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, 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 (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 The Company leased 953 square feet of office space in Reno, Nevada for research and development activities from a company owned by the Company’s former Vice President of Research and Development. The lease, as amended, expired on September 14, 2022 and provided for lease payments of $5,404 per month and a security deposit in the amount of $5,404. The Company has remained in the premises on a month-to-month basis at the same rental rate. Since the inception of the lease, the Company has made $112,600 of leasehold improvements related to this lease which have been fully amortized on the accompanying balance sheets. The Company’s rent expense for this space is recorded in Research and Development on the condensed statement of operations and amounted to $16,212 for the three months ended September 30, 2022 and 2021, and $48,636 for the nine months ended September 30, 2022 and 2021. On April 8, 2022, the Company agreed to enter into a lease agreement for a new office space of 3,916 square feet commencing on June 1, 2022 in Laguna Hills, CA. The lease expires on July 31, 2027 and provides for lease payments of $9,203 per month payable on the first day of each month commencing September 1, 2022, and a security deposit of $11,400. The Company’s rent expense for this space is recorded in General and Administrative on the condensed statement of operations and amounted to $28,371 during the three months ended September 30, 2022 and $37,828 during the nine months ended September 30, 2022. On May 19, 2022, the Company agreed to enter into a lease agreement with a non-related party for a new office space located in Reno, Nevada of 10,881 square feet commencing on May 23, 2022. The amended lease expires on September 23, 2027 with an option to extend the lease for an additional period of 60 months, and provides for lease payments ranging from $13,056 per month to $16,663 per month and a security deposit of $53,000. The Company’s rent expense for this space is recorded in Research and Development on the condensed statement of operations and amounted to $41,238 during the three months ended September 30, 2022 and $59,787 during the nine months ended September 30, 2022. Litigations, Claims and Assessments The Company may be involved in legal proceedings, claims and assessments arising in the ordinary course of business. The Company records legal costs associated with loss contingencies as incurred and accrues for all probable and estimable settlements. |
Stockholders' Equity
Stockholders' Equity | 9 Months Ended |
Sep. 30, 2022 | |
Stockholders' Equity | |
Stockholders' Equity | Note 8 – Stockholders’ Equity At-The-Market Offerings December 2021 Sales Agreement On December 14, 2021, the Company entered into a Sales Agreement (the “December 2021 Sales Agreement”) with SVB Leerink 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 Leerink as its sales agent (the “At-the-Market Offering”). The Company’s prior sales agreement, with SVB Leerink, entered into in May 2021, 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 (the “Registration Statement”), and the prospectus relating to the At-the-Market Offering filed therewith that forms a part of the Registration Statement. Subject to the terms and conditions of the December 2021 Sales Agreement, SVB Leerink 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 Leerink 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 Leerink a commission equal to three percent (3.0)% of the gross sales proceeds of any common stock sold through SVB Leerink under the December 2021 Sales Agreement, and also has provided SVB Leerink with certain indemnification rights. Through September 30, 2022, the Company received approximately $4.0 million in net proceeds from the sale of 2,128,763 shares of its common stock pursuant to the December 2021 Sales Agreement. Securities Purchase Agreement On March 3, 2022, the Company entered into a securities purchase agreement (the “Purchase Agreement”) with an institutional and accredited investor (the “Purchaser”), relating to the issuance and sale of 3,000,000 shares (the “Shares”) of common stock, pre-funded warrants (the “Pre-Funded Warrants”) to purchase an aggregate of 1,870,130 shares of common stock and warrants to purchase an aggregate of 4,870,130 shares of common stock (the “Investor Warrants”) in a registered direct offering (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 have an exercise price of $3.54 per share and each Investor Warrant is 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 are 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 with aggregate issuance costs of approximately $83,000, 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 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. Equity Incentive Plan On June 16, 2022, the stockholders approved an amendment to the Company’s Amended and Restated 2018 Omnibus Stock Incentive Plan, reserving an additional 1,500,000 shares of common stock for further issuance under such plan. Stock-Based Compensation Expense The Company records stock-based compensation expense related to stock options and restricted stock units (“RSUs”). For the three months ended September 30, 2022 and 2021, the Company recorded expense of $928,733 ($420,619 of which was included within research and development expenses and $508,114 was included within general and administrative expenses on the statements of operations) and $777,467 ($489,121 of which was included within research and development expenses and $288,343 was included within general and administrative expenses on the statements of operations), respectively. For the nine months ended September 30, 2022 and 2021, the Company recorded expense of $2,874,646 ($1,438,469 of which was included within research and development expenses and $1,436,177 was included within general and administrative expenses on the statements of operations) and $2,071,735 ($1,138,331 of which was included within research and development expenses and $933,401 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 nine months ended September 30, 2022 is presented below: Weighted Average Number of Grant Date Value RSUs Per Share 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 September 30, 2022 172,800 $ 1.80 Vested RSUs undelivered September 30, 2022 41,086 $ 3.64 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. As of September 30, 2022, there was $254,152 of unrecognized stock-based compensation expense related to RSUs which will be recognized over a weighted average period of 0.8 years. Stock Options In applying the Black-Scholes option pricing model to stock options granted, the Company used the following approximate assumptions: For the Three Months Ended For the Nine Months Ended September 30, September 30, 2022 2021 2022 2021 Expected term (years) 5.41 - 5.85 5.85 0.58 - 10.00 5.85 - 10.00 Risk free interest rate 2.66% - 3.02% 0.81% 0.76% - 3.35% 0.45% - 1.58% Expected volatility 85% - 87% 92% 82% - 90% 92% - 94% Expected dividends 0.00% 0.00% 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 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” employee 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 weighted average estimated grant date fair value of the stock options granted for the three months ended September 30, 2022 and 2021 was approximately $1.22 and $3.56 per share, respectively. The weighted average estimated grant date fair value of the stock options granted for the nine months ended September 30, 2022 and 2021 was approximately $1.61 and $4.16 per share, respectively. A summary of the option activity during the nine months ended September 30, 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 1,167,310 2.23 Forfeited (60,021) 4.21 Outstanding, September 30, 2022 5,484,687 $ 3.53 7.4 $ 375,417 Exercisable, September 30, 2022 3,518,147 $ 3.72 6.5 $ 188,738 The following table presents information related to stock options as of September 30, 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 1,577,286 4.1 827,636 $2.00 - $2.99 1,010,018 7.7 762,034 $3.00 - $3.99 1,241,069 7.0 820,883 $4.00 - $4.99 385,305 8.8 147,760 $5.00 - $5.99 100,805 6.2 79,805 $6.00 - $6.99 1,005,286 7.1 715,111 $7.00 + 164,918 5.5 164,918 5,484,687 6.5 3,518,147 As of September 30, 2022, there was $4,058,569 of unrecognized stock-based compensation expense related to stock options which will be recognized over a weighted average period of 1.6 years. Warrants A summary of the warrant activity for the nine months ended September 30, 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 September 30, 2022 6,087,845 $ 3.37 4.5 $ — Exercisable September 30, 2022 6,087,845 $ 3.37 4.5 $ — The following table presents information related to warrants as of September 30, 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 2.5 909,451 $2.7240 216,380 2.5 216,380 $4.7600 91,884 8.6 91,884 $3.5400 4,870,130 4.9 4,870,130 6,087,845 4.5 6,087,845 Stock Warrant Exercises During the nine months ended September 30, 2022, the Company issued an aggregate of 1,870,130 shares of common stock pursuant to the exercise of pre-funded warrants for aggregate proceeds of $18,701 at an exercise price of $0.01 per share. |
Employee Benefit Plans
Employee Benefit Plans | 9 Months Ended |
Sep. 30, 2022 | |
Employee Benefit Plans | |
Employee Benefit Plans | Note 9 – Employee Benefit Plans 401(k) Plan In April 2019, the Company adopted the Eyenovia 401(k) Plan (the “Plan”), which went into effect in May 2019. All Company employees are able to participate in the Plan, subject to eligibility requirements as outlined in the Plan documents. Under the terms of the Plan, eligible employees are able to defer a percentage of their pay every pay period up to annual limitations set by Congress and the Internal Revenue Service under Section 401(k) of the Internal Revenue Code. For 2022 and 2021, the Board 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. During the three months ended September 30, 2022 and 2021, the Company recorded expense of $39,914 and $34,076 associated with its matching contributions, respectively. During the nine months ended September 30, 2022 and 2021, the Company recorded expense of $173,896 and $144,917 associated with its matching contributions, respectively. |
Subsequent Events
Subsequent Events | 9 Months Ended |
Sep. 30, 2022 | |
Subsequent Events | |
Subsequent Events | Note 10 – Subsequent Events At-the-Market Offering Program Subsequent to September 30, 2022, the Company received approximately $1.4 million in gross proceeds ($1.3 million in net proceeds) from the sale of 587,298 shares of our common stock pursuant to our At-the-Market Offering program with SVB Leerink. SVB Loan Repayment On November 4, 2022, the Company repaid the SVB Loan in full. The full amount of the payment was $8.0 million, and included the principal amount of the loan ($7,500,000), the final payment ($375,000) and a 2% prepayment fee ($150,000). The entire restricted cash account in the amount of $7,875,000 was used to make the substantial amount of the payment. |
Summary of Significant Accoun_2
Summary of Significant Accounting Policies (Policies) | 9 Months Ended |
Sep. 30, 2022 | |
Summary of Significant Accounting Policies | |
Liquidity and Going Concern | Liquidity and Going Concern As of September 30, 2022, the Company had unrestricted cash of approximately $17.4 million and an accumulated deficit of approximately $112.1 million. For the nine months ended September 30, 2022 and 2021, the Company incurred net losses of approximately $21.9 million and $15.8 million, respectively, and used cash in operations of approximately $19.7 million and $15.0 million, respectively. Subsequent to September 30, 2022, the Company received approximately $1.3 million in net proceeds from the sale of 587,298 shares of common stock pursuant to the Company’s At-the-Market Offering program with SVB Leerink. Also subsequent to September 30, 2022, the Company used its $7.9 million of restricted cash and $0.1 million of unrestricted cash in order to repay the Loan and Security Agreement, dated May 7, 2021 (the “SVB Loan”) with Silicon Valley Bank (“SVB”), including $7.5 million of principal, a final payment of $0.4 million and a prepayment fee of $0.1 million. The Company does not have recurring revenue and has not yet achieved profitability. The Company expects to continue to incur cash outflows from operations. The Company expects that its research and development and general and administrative expenses will continue to increase and, as a result, it will eventually need to generate significant product revenues to achieve profitability. These circumstances raise substantial doubt about the Company’s ability to continue as a going concern for at least one year from the date that these financial statements are issued. Implementation of the Company’s plans and its ability to continue as a going concern will depend upon the Company’s ability to commercialize its products and raise further capital, through licensing transactions, 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 secure additional capital, it may be required to curtail its research and development initiatives and take additional measures to reduce general and administrative and sales and marketing costs in order to conserve its cash. |
Cash and Cash Equivalents | Cash and Cash Equivalents 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, such as the collateralized money market account pursuant to the SVB Loan, as amended on September 29, 2021 by the First Amendment to the Loan and Security Agreement (the “First Amendment”). See Note 6 - Notes Payable. In connection with the First Amendment, the Company pledged to establish and maintain a collateralized money market account in the amount of $7,875,000. Subsequent to September 30, 2022, the Company used this entire collateralized money market account plus $0.1 million of unrestricted cash in order to repay the SVB Loan, including $7.5 million of principal, a final payment of $0.4 million and a prepayment fee of $0.1 million. The Company has cash deposits in a financial institution which, at times, may be in excess of Federal Deposit Insurance Corporation (“FDIC”) insurance limits. The Company has not experienced losses in such accounts and periodically evaluates the creditworthiness of its financial institutions. As of September 30, 2022 and December 31, 2021, the Company had cash balances in excess of FDIC insurance limits of $24,773,605 and $26,836,850, respectively. |
Net Loss Per Common Share | Net Loss Per Common Share Basic net loss per common share is computed by dividing net loss by the weighted average number of common shares outstanding during the period plus fully vested shares that are subject to issuance for little or no monetary consideration. Diluted earnings per share reflects the potential dilution that could occur if securities or other instruments to issue common stock were exercised or converted into common stock. The following securities are excluded from the calculation of weighted average diluted common shares because their inclusion would have been anti-dilutive: September 30, 2022 2021 Options 5,484,687 3,410,540 Warrants 6,087,845 2,095,993 Restricted stock units 172,800 105,306 Total potentially dilutive shares 11,745,332 5,611,839 |
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 Accounting Standards Codification (“ASC”) Topic 808, “Collaborative Arrangements” (“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” (“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, we recognize revenue when our customers obtain control of promised goods or services, in an amount that reflects the consideration which we expect to receive in exchange for those goods or services. To determine revenue recognition for arrangements that we determine are within the scope of ASC 606, we perform 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. In addition, 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 whether these options provide a material right to the customer and if so, they are considered performance obligations. For upfront license fees, the Company must consider how many performance obligations are in the contract and, if more than one, how to allocate the fee to those performance obligations upon satisfaction of the performance obligation(s). 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. During 2020, the Company entered into a license agreement (the “Arctic Vision License Agreement”) with Arctic Vision (Hong Kong) Limited (“Arctic Vision”) and a license agreement (the “Bausch License Agreement”) with Bausch + Lomb, Inc. (“Bausch + Lomb”). Each license has three revenue components: 1) an upfront license fee; 2) milestone payments and 3) royalty payments. |
Deferred License Fee | Deferred License Fee The Company enters into license agreements which provide for the receipt of non-refundable, upfront licensing payments. These payments are recorded as deferred license fees and will be earned and recognized as revenue upon the satisfaction of performance obligations. See Note 7 – Commitments and Contingencies for additional details. |
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. |
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. |
Recently Adopted Accounting Standards | Recently Adopted Accounting Standards On May 3, 2021, the Financial Accounting Standards Board (the “FASB”) issued Accounting Standards Update (“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. |
Soon To Be Adopted Accounting Standards | Soon To Be Adopted Accounting Standards In February 2016, the FASB issued ASU 2016-02 “Leases (Topic 842)” (“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 plans to adopt ASU 2016-02 on December 31, 2022 and expects that the adoption of this ASU will have 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 $1.3 million and $1.4 million, respectively. |
Summary of Significant Accoun_3
Summary of Significant Accounting Policies (Tables) | 9 Months Ended |
Sep. 30, 2022 | |
Summary of Significant Accounting Policies | |
Schedule of anti-dilutive weighted average diluted common shares | September 30, 2022 2021 Options 5,484,687 3,410,540 Warrants 6,087,845 2,095,993 Restricted stock units 172,800 105,306 Total potentially dilutive shares 11,745,332 5,611,839 |
Prepaid Expenses and Other Cu_2
Prepaid Expenses and Other Current Assets (Tables) | 9 Months Ended |
Sep. 30, 2022 | |
Prepaid Expenses and Other Current Assets | |
Schedule of prepaid expenses and other current assets | September 30, December 31, 2022 2021 Payroll tax receivable 621,063 343,785 Prepaid insurance expenses 455,150 171,370 Prepaid general and administrative expenses 185,845 71,375 Prepaid conference expenses 100,803 12,586 Prepaid patent expenses 49,183 32,797 Other 32,226 4,525 Prepaid security deposits 18,750 18,750 Prepaid board of directors fees — 66,250 Total prepaid expenses and other current assets $ 1,463,020 $ 721,438 |
Accrued Compensation (Tables)
Accrued Compensation (Tables) | 9 Months Ended |
Sep. 30, 2022 | |
Accrued Compensation | |
Schedule of accrued compensation | September 30, December 31, 2022 2021 Accrued bonus expenses $ 971,159 $ 1,245,795 Accrued payroll expenses 296,850 297,823 Total accrued compensation $ 1,268,009 $ 1,543,618 |
Accrued Expenses and Other Cu_2
Accrued Expenses and Other Current Liabilities (Tables) | 9 Months Ended |
Sep. 30, 2022 | |
Accrued Expenses and Other Current Liabilities | |
Schedule of accrued expenses and other current liabilities | September 30, December 31, 2022 2021 Accrued research and development expenses $ 711,710 $ 436,840 Accrued consulting and professional services 386,712 250,000 Accrued interest 152,969 94,792 Credit card payable 58,799 20,000 Accrued franchise tax 39,300 1,680 Other 29,647 42,407 Accrued travel and entertainment expenses 5,666 — Total accrued expenses and other current liabilities $ 1,384,803 $ 845,719 |
Notes Payable (Tables)
Notes Payable (Tables) | 9 Months Ended |
Sep. 30, 2022 | |
Notes Payable | |
Schedule of notes payable | September 30, 2022 December 31, 2021 Notes Payable Debt Discount Net Notes Payable Debt Discount Net Silicon Valley Bank loan $ 7,500,000 $ (270,987) $ 7,229,013 $ 7,500,000 $ (349,632) $ 7,150,368 |
Stockholders' Equity (Tables)
Stockholders' Equity (Tables) | 9 Months Ended |
Sep. 30, 2022 | |
Stockholders' Equity | |
Summary Of Restricted Stock Units Activity | Weighted Average Number of Grant Date Value RSUs Per Share 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 September 30, 2022 172,800 $ 1.80 Vested RSUs undelivered September 30, 2022 41,086 $ 3.64 |
Schedule of Black-Scholes option pricing model to stock options granted | For the Three Months Ended For the Nine Months Ended September 30, September 30, 2022 2021 2022 2021 Expected term (years) 5.41 - 5.85 5.85 0.58 - 10.00 5.85 - 10.00 Risk free interest rate 2.66% - 3.02% 0.81% 0.76% - 3.35% 0.45% - 1.58% Expected volatility 85% - 87% 92% 82% - 90% 92% - 94% Expected dividends 0.00% 0.00% 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 1,167,310 2.23 Forfeited (60,021) 4.21 Outstanding, September 30, 2022 5,484,687 $ 3.53 7.4 $ 375,417 Exercisable, September 30, 2022 3,518,147 $ 3.72 6.5 $ 188,738 |
Schedule of information related to stock options | The following table presents information related to stock options as of September 30, 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 1,577,286 4.1 827,636 $2.00 - $2.99 1,010,018 7.7 762,034 $3.00 - $3.99 1,241,069 7.0 820,883 $4.00 - $4.99 385,305 8.8 147,760 $5.00 - $5.99 100,805 6.2 79,805 $6.00 - $6.99 1,005,286 7.1 715,111 $7.00 + 164,918 5.5 164,918 5,484,687 6.5 3,518,147 |
Summary 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 September 30, 2022 6,087,845 $ 3.37 4.5 $ — Exercisable September 30, 2022 6,087,845 $ 3.37 4.5 $ — |
Schedule of warrants outstanding | The following table presents information related to warrants as of September 30, 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 2.5 909,451 $2.7240 216,380 2.5 216,380 $4.7600 91,884 8.6 91,884 $3.5400 4,870,130 4.9 4,870,130 6,087,845 4.5 6,087,845 |
Business Organization, Nature_2
Business Organization, Nature of Operations and Basis of Presentation (Details) | 9 Months Ended |
Sep. 30, 2022 | |
Business Organization, Nature of Operations and Basis of Presentation | |
High rate of Optejet | 98% |
Rate of traditional eye drops | 50% |
Technology Provides Reduction In Ocular Drug And Preservative Exposure, Percent | 75% |
Percentage eyedrops expose the ocular surface | 300% |
Summary of Significant Accoun_4
Summary of Significant Accounting Policies - Anti-dilutive weighted average diluted common shares (Details) - shares | 9 Months Ended | |
Sep. 30, 2022 | Sep. 30, 2021 | |
Anti-dilutive securities | ||
Total potentially dilutive shares | 11,745,332 | 5,611,839 |
Option | ||
Anti-dilutive securities | ||
Total potentially dilutive shares | 5,484,687 | 3,410,540 |
Warrants | ||
Anti-dilutive securities | ||
Total potentially dilutive shares | 6,087,845 | 2,095,993 |
Restricted stock units | ||
Anti-dilutive securities | ||
Total potentially dilutive shares | 172,800 | 105,306 |
Summary of Significant Accoun_5
Summary of Significant Accounting Policies - Additional Information (Details) - USD ($) | 3 Months Ended | 9 Months Ended | |||||||||||
Nov. 04, 2022 | Oct. 01, 2022 | Mar. 03, 2022 | Dec. 14, 2021 | Sep. 30, 2022 | Jun. 30, 2022 | Mar. 31, 2022 | Sep. 30, 2021 | Jun. 30, 2021 | Mar. 31, 2021 | Sep. 30, 2022 | Sep. 30, 2021 | Dec. 31, 2021 | |
Summary of Significant Accounting Policies | |||||||||||||
Cash and cash equivalents | $ 17,398,605 | $ 13,500,871 | $ 17,398,605 | $ 13,500,871 | $ 19,461,850 | ||||||||
Accumulated deficit | (112,107,067) | (112,107,067) | (90,219,306) | ||||||||||
Net loss | (7,308,996) | $ (7,239,100) | $ (7,339,665) | $ (5,568,598) | $ (4,841,400) | $ (5,351,667) | (21,887,761) | (15,761,665) | |||||
Cash used in operations | (19,700,622) | $ (14,997,807) | |||||||||||
Amount pledged to establish and maintain a collateralized money market account | 7,875,000 | 7,875,000 | |||||||||||
Cash, Uninsured Amount | 24,773,605 | 24,773,605 | $ 26,836,850 | ||||||||||
Accounting Standards Update 2016-02 | Cumulative Effect, Period of Adoption, Adjustment | |||||||||||||
Summary of Significant Accounting Policies | |||||||||||||
Operating lease, Right of use assets | 1,300,000 | 1,300,000 | |||||||||||
Operating lease, liabilities | $ 1,400,000 | $ 1,400,000 | |||||||||||
Securities purchase agreement | |||||||||||||
Summary of Significant Accounting Policies | |||||||||||||
Net proceeds | 3,000,000 | ||||||||||||
Securities purchase agreement | March 2022 offering | |||||||||||||
Summary of Significant Accounting Policies | |||||||||||||
Proceeds from issuance of common stock | $ 15,000,000 | ||||||||||||
Clinical Supply Arrangements | |||||||||||||
Summary of Significant Accounting Policies | |||||||||||||
Clinical trials, percentage of additional mark-up on cost | 10% | ||||||||||||
December 2021 Sales Agreement | |||||||||||||
Summary of Significant Accounting Policies | |||||||||||||
Proceeds from issuance of common stock | $ 50,000,000 | $ 4,000,000 | |||||||||||
Net proceeds | 2,128,763 | ||||||||||||
Subsequent Event | |||||||||||||
Summary of Significant Accounting Policies | |||||||||||||
Proceeds from issuance of common stock | $ 1,300,000 | ||||||||||||
Net proceeds | 587,298 | ||||||||||||
Subsequent Event | Silicon Valley Bank loan | |||||||||||||
Summary of Significant Accounting Policies | |||||||||||||
Cash and cash equivalents | $ 100,000 | ||||||||||||
Restricted cash used for substantial repayment | 7,875,000 | ||||||||||||
Aggregate principal payments | 7,500,000 | ||||||||||||
Final payment | 400,000 | ||||||||||||
Prepayment fee | $ 100,000 |
Prepaid Expenses and Other Cu_3
Prepaid Expenses and Other Current Assets (Details) - USD ($) | Sep. 30, 2022 | Dec. 31, 2021 |
Prepaid Expenses and Other Current Assets | ||
Payroll tax receivable | $ 621,063 | $ 343,785 |
Prepaid insurance expenses | 455,150 | 171,370 |
Prepaid general and administrative expenses | 185,845 | 71,375 |
Prepaid conference expenses | 100,803 | 12,586 |
Prepaid patent expenses | 49,183 | 32,797 |
Other | 32,226 | 4,525 |
Prepaid security deposits | 18,750 | 18,750 |
Prepaid board of directors fees | 0 | 66,250 |
Total prepaid expenses and other current assets | $ 1,463,020 | $ 721,438 |
Accrued Compensation (Details)
Accrued Compensation (Details) - USD ($) | Sep. 30, 2022 | Dec. 31, 2021 |
Accrued Compensation | ||
Accrued bonus expenses | $ 971,159 | $ 1,245,795 |
Accrued payroll expenses | 296,850 | 297,823 |
Total accrued compensation | $ 1,268,009 | $ 1,543,618 |
Accrued Expenses and Other Cu_3
Accrued Expenses and Other Current Liabilities (Details) - USD ($) | Sep. 30, 2022 | Dec. 31, 2021 |
Accrued Expenses and Other Current Liabilities | ||
Accrued research and development expenses | $ 711,710 | $ 436,840 |
Accrued consulting and professional services | 386,712 | 250,000 |
Accrued interest | 152,969 | 94,792 |
Credit card payable | 58,799 | 20,000 |
Accrued franchise tax | 39,300 | 1,680 |
Other | 29,647 | 42,407 |
Accrued travel and entertainment expenses | 5,666 | 0 |
Total accrued expenses and other current liabilities | $ 1,384,803 | $ 845,719 |
Notes Payable - Schedule of not
Notes Payable - Schedule of notes payable (Details) - Silicon Valley Bank loan - USD ($) | Sep. 30, 2022 | Dec. 31, 2021 |
Notes payable | ||
Notes Payable, Total | $ 7,500,000 | $ 7,500,000 |
Debt Discount, Total | (270,987) | (349,632) |
Notes payable, Net of Debt Discount, Total | $ 7,229,013 | $ 7,150,368 |
Notes Payable - Additional Info
Notes Payable - Additional Information (Details) - USD ($) | 3 Months Ended | 9 Months Ended | ||||
Feb. 24, 2022 | May 07, 2021 | Sep. 30, 2022 | Sep. 30, 2022 | Sep. 30, 2021 | Dec. 31, 2021 | |
Notes Payable | ||||||
Notes payable | $ 7,229,013 | $ 7,229,013 | $ 7,150,368 | |||
Repayments of loan | 675,332 | $ 547,259 | ||||
Debt issuance costs | 0 | $ 66,618 | ||||
D&O insurance policy loan | ||||||
Notes Payable | ||||||
Number of monthly payments | 6 months | |||||
Notes payable | $ 675,332 | |||||
Number of monthly payments | $ 113,628 | |||||
Interest rate (as a percent) | 3.26% | |||||
Maturity date | Aug. 24, 2022 | |||||
Repayments of loan | 675,332 | |||||
Amortization of debt discount | 26,214 | 78,645 | ||||
Debt issuance costs | 923 | 6,435 | ||||
Silicon Valley Bank loan | ||||||
Notes Payable | ||||||
Interest expense | 177,138 | 475,811 | ||||
Loan issuance costs | $ 176,215 | $ 469,376 | ||||
Net present value (as a percent) | 0.10% |
Commitments and Contingencies -
Commitments and Contingencies - Additional Information (Details) | 3 Months Ended | 9 Months Ended | ||||||
Jul. 26, 2022 USD ($) shares | May 19, 2022 USD ($) ft² | Apr. 08, 2022 USD ($) ft² | Sep. 30, 2022 USD ($) ft² | Sep. 30, 2021 USD ($) | Sep. 30, 2022 USD ($) ft² | Sep. 30, 2021 USD ($) | Feb. 14, 2022 USD ($) | |
Commitments and Contingencies | ||||||||
Aggregate current base salary | $ 1,517,000 | |||||||
Mr. Rowe | ||||||||
Commitments and Contingencies | ||||||||
Annual salary | $ 575,000 | |||||||
Aggregate potential severance pay for executive officers | $ 1,004,000 | |||||||
Maximum cash bonus percentage | 60% | |||||||
Number of options to purchase common stock, shares issued | shares | 440,000 | |||||||
Dr. Ianchulev, Executive Chairman | ||||||||
Commitments and Contingencies | ||||||||
Initial period of service | 1 year | |||||||
Monthly retainer | $ 5,000 | |||||||
Lease agreement for new office located in Laguna Hills, CA | ||||||||
Commitments and Contingencies | ||||||||
Area of land | ft² | 3,916 | |||||||
Lease expiration date | Jul. 31, 2027 | |||||||
Lease payments per month | $ 9,203 | |||||||
Security deposit | $ 11,400 | |||||||
Lease agreement for new office located in Reno, Nevada | ||||||||
Commitments and Contingencies | ||||||||
Area of land | ft² | 10,881 | |||||||
Lease expiration date | Sep. 23, 2027 | |||||||
Security deposit | $ 53,000 | |||||||
Additional number of months in which option to extend the lease | 60 months | |||||||
Lease agreement for new office located in Reno, Nevada | Minimum | ||||||||
Commitments and Contingencies | ||||||||
Lease payments per month | $ 13,056 | |||||||
Lease agreement for new office located in Reno, Nevada | Maximum | ||||||||
Commitments and Contingencies | ||||||||
Lease payments per month | $ 16,663 | |||||||
Research and Development | ||||||||
Commitments and Contingencies | ||||||||
Rent expense | $ 48,636 | $ 48,636 | ||||||
Research and Development | Lease agreement for new office located in Reno, Nevada | ||||||||
Commitments and Contingencies | ||||||||
Rent expense | $ 41,238 | 59,787 | ||||||
General and Administrative | Lease agreement for new office located in Laguna Hills, CA | ||||||||
Commitments and Contingencies | ||||||||
Rent expense | $ 28,371 | $ 37,828 | ||||||
Vice President of Research And Development | ||||||||
Commitments and Contingencies | ||||||||
Net rentable area | ft² | 953 | 953 | ||||||
Lease payments | $ 5,404 | |||||||
Security and equipment deposits | $ 5,404 | 5,404 | ||||||
Leasehold improvements | 112,600 | $ 112,600 | ||||||
Lease expiration date | Sep. 14, 2022 | |||||||
Vice President of Research And Development | Research and Development | ||||||||
Commitments and Contingencies | ||||||||
Rent expense | $ 16,212 | $ 16,212 |
Stockholders' Equity - Restrict
Stockholders' Equity - Restricted stock units activity (Details) | 9 Months Ended |
Sep. 30, 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 | 41,086 |
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 September 30, 2022 | $ / shares | 1.80 |
Vested RSUs undelivered September 30, 2022 | $ / shares | $ 3.64 |
Stockholders' Equity - Black Sc
Stockholders' Equity - Black Scholes option (Details) | 3 Months Ended | 9 Months Ended | ||
Sep. 30, 2022 | Sep. 30, 2021 | Sep. 30, 2022 | Sep. 30, 2021 | |
Expected term (years) | 5 years 10 months 6 days | |||
Risk free interest rate | 0.81% | |||
Expected volatility | 92% | |||
Expected dividends | 0% | 0% | 0% | 0% |
Minimum | ||||
Expected term (years) | 5 years 4 months 28 days | 5 years 10 months 6 days | 6 months 29 days | 5 years 10 months 6 days |
Risk free interest rate | 2.66% | 0.81% | 0.76% | 0.45% |
Expected volatility | 85% | 82% | 92% | |
Maximum | ||||
Expected term (years) | 5 years 10 months 6 days | 10 years | 10 years | |
Risk free interest rate | 3.02% | 3.35% | 1.58% | |
Expected volatility | 87% | 90% | 94% |
Stockholders' Equity - Summary
Stockholders' Equity - Summary of option activity (Details) - Stock Options - USD ($) | 9 Months Ended |
Sep. 30, 2022 | |
Number of Options, Outstanding | Shares | 4,377,398 |
Number of Options, Granted | Shares | 1,167,310 |
Number of Options, Forfeited | Shares | (60,021) |
Number of Options, Outstanding | Shares | 5,484,687 |
Number of Options, Exercisable | Shares | 3,518,147 |
Weighted Average Exercise Price, Outstanding | $ / Shares | $ 3.89 |
Weighted Average Exercise Price, Granted | $ / Shares | 2.23 |
Weighted Average Exercise Price, Forfeited | $ / Shares | 4.21 |
Weighted Average Exercise Price, Outstanding | $ / Shares | 3.53 |
Weighted Average Exercise Price, Exercisable | $ / Shares | $ 3.72 |
Weighted Average Remaining Life In Years, Outstanding | 7 years 4 months 24 days |
Weighted Average Remaining Life In Years, Exercisable | 6 years 6 months |
Aggregate Intrinsic Value, Outstanding | $ | $ 375,417 |
Aggregate Intrinsic Value, Exercisable | $ 188,738 |
Stockholders' Equity - Summar_2
Stockholders' Equity - Summary of information related to stock options (Details) | 9 Months Ended |
Sep. 30, 2022 $ / shares shares | |
Options Outstanding, Outstanding Number of Options | 5,484,687 |
Options Exercisable, Weighted Average Remaining Life In Years | 6 years 6 months |
Options Exercisable, Exercisable Number of Options | 3,518,147 |
Exercise Price, $1.00 - $1.99 | |
Options Outstanding, Outstanding Number of Options | 1,577,286 |
Options Exercisable, Weighted Average Remaining Life In Years | 4 years 1 month 6 days |
Options Exercisable, Exercisable Number of Options | 827,636 |
Exercise Price, $1.00 - $1.99 | Minimum | |
Options Outstanding, Outstanding Exercise Price | $ / shares | $ 1 |
Exercise Price, $1.00 - $1.99 | Maximum | |
Options Outstanding, Outstanding Exercise Price | $ / shares | $ 1.99 |
Exercise Price, $2.00 - $2.99 | |
Options Outstanding, Outstanding Number of Options | 1,010,018 |
Options Exercisable, Weighted Average Remaining Life In Years | 7 years 8 months 12 days |
Options Exercisable, Exercisable Number of Options | 762,034 |
Exercise Price, $2.00 - $2.99 | Minimum | |
Options Outstanding, Outstanding Exercise Price | $ / shares | $ 2 |
Exercise Price, $2.00 - $2.99 | Maximum | |
Options Outstanding, Outstanding Exercise Price | $ / shares | $ 2.99 |
Exercise Price, $3.00 - $3.99 | |
Options Outstanding, Outstanding Number of Options | 1,241,069 |
Options Exercisable, Weighted Average Remaining Life In Years | 7 years |
Options Exercisable, Exercisable Number of Options | 820,883 |
Exercise Price, $3.00 - $3.99 | Minimum | |
Options Outstanding, Outstanding Exercise Price | $ / shares | $ 3 |
Exercise Price, $3.00 - $3.99 | Maximum | |
Options Outstanding, Outstanding Exercise Price | $ / shares | $ 3.99 |
Exercise Price, $4.00 - $4.99 | |
Options Outstanding, Outstanding Number of Options | 385,305 |
Options Exercisable, Weighted Average Remaining Life In Years | 8 years 9 months 18 days |
Options Exercisable, Exercisable Number of Options | 147,760 |
Exercise Price, $4.00 - $4.99 | Minimum | |
Options Outstanding, Outstanding Exercise Price | $ / shares | $ 4 |
Exercise Price, $4.00 - $4.99 | Maximum | |
Options Outstanding, Outstanding Exercise Price | $ / shares | $ 4.99 |
Exercise Price, $5.00 - $5.99 | |
Options Outstanding, Outstanding Number of Options | 100,805 |
Options Exercisable, Weighted Average Remaining Life In Years | 6 years 2 months 12 days |
Options Exercisable, Exercisable Number of Options | 79,805 |
Exercise Price, $5.00 - $5.99 | Minimum | |
Options Outstanding, Outstanding Exercise Price | $ / shares | $ 5 |
Exercise Price, $5.00 - $5.99 | Maximum | |
Options Outstanding, Outstanding Exercise Price | $ / shares | $ 5.99 |
Exercise Price, $6.00 - $6.99 | |
Options Outstanding, Outstanding Number of Options | 1,005,286 |
Options Exercisable, Weighted Average Remaining Life In Years | 7 years 1 month 6 days |
Options Exercisable, Exercisable Number of Options | 715,111 |
Exercise Price, $6.00 - $6.99 | Minimum | |
Options Outstanding, Outstanding Exercise Price | $ / shares | $ 6 |
Exercise Price, $6.00 - $6.99 | Maximum | |
Options Outstanding, Outstanding Exercise Price | $ / shares | 6.99 |
Exercise Price, $7.00+ | |
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 6 months |
Options Exercisable, Exercisable Number of Options | 164,918 |
Stockholders' Equity - Warrants
Stockholders' Equity - Warrants Activity (Details) | 9 Months Ended |
Sep. 30, 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 6 months |
Weighted Average Remaining Life, Exercisable | 4 years 6 months |
Stockholders' Equity - Related
Stockholders' Equity - Related to warrants (Details) - USD ($) | 9 Months Ended | ||
Sep. 30, 2022 | Sep. 30, 2021 | Dec. 31, 2021 | |
Related to warrants | |||
Exercise price | $ 0.01 | ||
Outstanding Number of Warrants | 6,087,845 | 1,217,715 | |
Weighted Average Remaining Life, Exercisable | 4 years 6 months | ||
Exercisable Number of Warrants | 6,087,845 | ||
Number of warrants exercised | 1,870,130 | ||
Proceeds from exercise of warrants | $ 18,701 | $ 2,103,991 | |
Warrants at exercise price of $2.4696 | |||
Related to warrants | |||
Exercise price | $ 2.4696 | ||
Outstanding Number of Warrants | 909,451 | ||
Weighted Average Remaining Life, Exercisable | 2 years 8 months 12 days | ||
Exercisable Number of Warrants | 909,451 | ||
Warrants at exercise price of $2.7240 | |||
Related to warrants | |||
Exercise price | $ 2.7240 | ||
Outstanding Number of Warrants | 216,380 | ||
Weighted Average Remaining Life, Exercisable | 2 years 6 months | ||
Exercisable Number of Warrants | 216,380 | ||
Warrants at exercise price of $4.7600 | |||
Related to warrants | |||
Exercise price | $ 4.7600 | ||
Outstanding Number of Warrants | 91,884 | ||
Weighted Average Remaining Life, Exercisable | 8 years 7 months 6 days | ||
Exercisable Number of Warrants | 91,884 | ||
Warrants at exercise price of $3.5400 | |||
Related to warrants | |||
Exercise price | $ 3.5400 | ||
Outstanding Number of Warrants | 4,870,130 | ||
Weighted Average Remaining Life, Exercisable | 4 years 10 months 24 days | ||
Exercisable Number of Warrants | 4,870,130 |
Stockholders' Equity - Addition
Stockholders' Equity - Additional Information (Details) - USD ($) | 3 Months Ended | 9 Months Ended | ||||||
Mar. 03, 2022 | Dec. 14, 2021 | Sep. 30, 2022 | Sep. 30, 2021 | Jun. 30, 2021 | Sep. 30, 2022 | Sep. 30, 2021 | Jun. 16, 2022 | |
Number of warrants issued | 1,870,130 | 1,870,130 | ||||||
Share-based compensation | $ 928,733 | $ 777,467 | $ 2,874,646 | $ 2,071,735 | ||||
Unrecognized stock - based compensation expense | $ 4,058,569 | $ 4,058,569 | ||||||
Weighted average period of recognition | 1 year 7 months 6 days | |||||||
Proceeds from Issuance of Warrants | $ 18,701 | |||||||
Proceeds from Stock Options Exercised | $ 0 | 176,802 | ||||||
Exercise price of warrants | $ 0.01 | $ 0.01 | ||||||
Securities purchase agreement | ||||||||
Net proceeds | 3,000,000 | |||||||
Share price | $ 3.08 | |||||||
Research and Development | ||||||||
Share-based compensation | $ 420,619 | 489,121 | $ 1,438,469 | 1,138,331 | ||||
General and Administrative | ||||||||
Share-based compensation | 508,114 | $ 288,343 | 1,436,177 | $ 933,401 | ||||
Restricted stock units | ||||||||
Unrecognized stock - based compensation expense | $ 254,152 | $ 254,152 | ||||||
Weighted average period of recognition | 9 months 18 days | |||||||
Options | ||||||||
Weighted average estimated grant date fair value | $ 1.22 | $ 3.56 | $ 1.61 | $ 4.16 | ||||
Common Stock | ||||||||
Share-based Compensation Arrangement by Share-based Payment Award, Options, Exercises in Period | 16,539 | 91,047 | ||||||
December 2021 Sales Agreement | ||||||||
Proceeds from issuance of common stock | $ 50,000,000 | $ 4,000,000 | ||||||
Net proceeds | 2,128,763 | |||||||
December 2021 Sales Agreement | Common Stock | ||||||||
Percentage on gross sale | 3% | |||||||
Amended and Restated 2018 Omnibus Stock Incentive Plan | ||||||||
Number of shares of common stock reserved for further issuance | 1,500,000 | |||||||
Pre-Funded Warrants | Securities purchase agreement | ||||||||
Number of warrants issued | 1,870,130 | |||||||
Share price | $ 3.07 | |||||||
Decrease in exercise price | $ 0.01 | |||||||
Investor Warrants | Securities purchase agreement | ||||||||
Number of warrants issued | 4,870,130 | |||||||
Share price | $ 3.54 | |||||||
March 2022 offering | Securities purchase agreement | ||||||||
Proceeds from issuance of common stock | $ 15,000,000 | |||||||
Aggregate issuance costs of pre-funded warrants and investor warrants | $ 83,000 |
Employee Benefit Plans (Details
Employee Benefit Plans (Details) - USD ($) | 1 Months Ended | 3 Months Ended | 9 Months Ended | ||
Apr. 30, 2019 | Sep. 30, 2022 | Sep. 30, 2021 | Sep. 30, 2022 | Sep. 30, 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 | $ 39,914 | $ 34,076 | $ 173,896 | $ 144,917 |
Subsequent Events (Details)
Subsequent Events (Details) - USD ($) | 9 Months Ended | |||
Nov. 04, 2022 | Oct. 01, 2022 | Sep. 30, 2022 | Sep. 30, 2021 | |
Subsequent Events | ||||
Repayments of long-term debt, total | $ 0 | $ 66,618 | ||
Subsequent Events | ||||
Subsequent Events | ||||
Gross proceeds | $ 1,300,000 | |||
Subsequent Events | Silicon Valley Bank loan | ||||
Subsequent Events | ||||
Repayments of long-term debt, total | $ 8,000,000 | |||
Aggregate principal payments | 7,500,000 | |||
Final payment of loan | $ 375,000 | |||
Percentage of prepayment fees | 2% | |||
Prepayment fees | $ 150,000 | |||
Restricted cash used for substantial repayment | $ 7,875,000 | |||
Subsequent Events | At Market Offering Program | ||||
Subsequent Events | ||||
Gross proceeds | 1,400,000 | |||
Net proceeds from At-the-Market Offering Program | $ 1,300,000 | |||
Subsequent Events | At Market Offering Program | Silicon Valley Bank loan | ||||
Subsequent Events | ||||
Number of shares sold in At-the-Market Offering Program | 587,298 |