UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
WASHINGTON, DC 20549
FORM
For the quarterly period ended:
OR
For the transition period from to
COMMISSION FILE NUMBER:
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The number of outstanding shares of the registrant’s common stock was
EYENOVIA, INC.
FORM 10-Q
FOR THE QUARTERLY PERIOD ENDED SEPTEMBER 30, 2024
TABLE OF CONTENTS
1
PART I – FINANCIAL INFORMATION
Item 1. Financial Statements.
EYENOVIA, INC.
Condensed Balance Sheets
| September 30, |
| December 31, | |||
| 2024 |
| 2023 | |||
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Assets |
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Current Assets |
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Cash and cash equivalents | $ | | $ | | ||
Inventories | | | ||||
Deferred clinical supply costs | | | ||||
License fee and expense reimbursements receivable | | | ||||
Security deposits, current | — | | ||||
Prepaid expenses and other current assets |
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Total Current Assets |
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Property and equipment, net |
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Security deposits, non-current |
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Intangible assets | | | ||||
Prepaid expenses, non-current | | - | ||||
Operating lease right-of-use asset | | | ||||
Equipment deposits |
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Total Assets | $ | | $ | | ||
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Liabilities and Stockholders’ Equity |
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Current Liabilities: |
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Accounts payable | $ | | $ | | ||
Accrued compensation |
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Accrued expenses and other current liabilities |
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Operating lease liabilities - current portion | | | ||||
Notes payable - current portion, net of debt discount of $ | | | ||||
Convertible notes payable - current portion, net of debt discount of $ | | — | ||||
Total Current Liabilities | | | ||||
Accrued expenses and other non-current liabilities | — | |||||
Operating lease liabilities - non-current portion | | | ||||
Notes payable - non-current portion, net of debt discount of $ | | |||||
Convertible notes payable - non-current portion, net of debt discount of $ |
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Total Liabilities | | | ||||
Commitments and contingencies (Note 8) |
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Stockholders’ Equity: |
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Preferred stock, $ |
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Common stock, $ |
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Additional paid-in capital |
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Accumulated deficit |
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Total Stockholders’ Equity | | | ||||
Total Liabilities and Stockholders’ Equity | $ | | $ | | ||
The accompanying notes are an integral part of these condensed financial statements.
2
EYENOVIA, INC.
Condensed Statements of Operations
(unaudited)
For the Three Months Ended | For the Nine Months Ended | |||||||||||
September 30, | September 30, | |||||||||||
| 2024 |
| 2023 |
| 2024 |
| 2023 | |||||
Operating Income | ||||||||||||
Revenue | $ | | $ | | $ | | $ | | ||||
Cost of revenue | ( | ( | ( | ( | ||||||||
Gross Loss | ( | ( | ( | ( | ||||||||
Operating Expenses: |
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Research and development | | | | | ||||||||
Selling, general and administrative |
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Reacquisition of license rights | — | — | | — | ||||||||
Total Operating Expenses |
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Loss From Operations |
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Other Income (Expense): |
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Other income (expense), net | | ( | ( | ( | ||||||||
Change in fair value of equity consideration payable | — | — | | — | ||||||||
Interest expense | ( |
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Interest income |
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Total Other Expense |
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Net Loss | $ | ( | $ | ( | $ | ( | $ | ( | ||||
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Net Loss Per Share - Basic and Diluted | $ | ( | $ | ( | $ | ( | $ | ( | ||||
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Shares Outstanding - Basic and Diluted |
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The accompanying notes are an integral part of these condensed financial statements.
3
EYENOVIA, INC.
Condensed Statements of Changes in Stockholders’ (Deficiency) Equity
(unaudited)
For the Three and Nine Months Ended September 30, 2024 | ||||||||||||||
Additional | Total | |||||||||||||
Common Stock | Paid-In | Accumulated | Stockholders’ | |||||||||||
| Shares |
| Amount |
| Capital |
| Deficit |
| (Deficiency) Equity | |||||
Balance - January 1, 2024 |
| | $ | | $ | | $ | ( | $ | | ||||
Issuance of common stock in At the Market Program [1] |
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Stock-based compensation |
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Net loss |
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Balance - March 31, 2024 |
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Issuance of common stock in offering [2] | | | | — | | |||||||||
Issuance of common stock as consideration for licensing agreement [3] |
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Issuance of common stock as consideration for reacquisition of licensing agreement [4] |
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Issuance of common stock in At the Market Program [5] |
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Stock-based compensation | — | — | | — | | |||||||||
Net loss | — | — | — | ( | ( | |||||||||
Balance - June 30, 2024 | | | | ( | ( | |||||||||
Issuance of common stock and warrants in offerings [6] | | | | — | | |||||||||
Warrant modification and additional warrants - incremental value (7) | — | — | | — | | |||||||||
Warrant modification and additional warrants - in issuance costs for offering (8) | — | — | ( | — | ( | |||||||||
Issuance of common stock in At the Market Program [9] | | | | — | | |||||||||
Stock-based compensation | — | — | | — | | |||||||||
Net loss | — | — | — | ( | ( | |||||||||
Balance - September 30, 2024 | | $ | | $ | | $ | ( | $ | | |||||
[1]
[2]
[3]
[4]
[5]
[6]
[7]
[8]
[9]
The accompanying notes are an integral part of these condensed financial statements.
4
EYENOVIA, INC.
Condensed Statements of Changes in Stockholders’ Equity, continued
(unaudited)
For the Three and Nine Months Ended September 30, 2023 | ||||||||||||||
Additional | Total | |||||||||||||
Common Stock | Paid-In | Accumulated | Stockholders’ | |||||||||||
| Shares |
| Amount |
| Capital |
| Deficit |
| Equity | |||||
Balance - January 1, 2023 | | $ | | $ | | $ | ( | $ | | |||||
Issuance of common stock in At the Market offering [1] | | | | — | | |||||||||
Cashless exercise of stock options | | | ( | — | — | |||||||||
Stock-based compensation | — | — | | — | | |||||||||
Issuance of common stock related to vested restricted stock units | | — | — | — | — | |||||||||
Net loss | — | — | — | ( | ( | |||||||||
Balance - March 31, 2023 | | | | ( | | |||||||||
Issuance of common stock in At the Market offering [2] | | | | — | | |||||||||
Cashless exercise of stock options | | — | — | — | — | |||||||||
Exercise of stock options | | | | — | | |||||||||
Stock-based compensation | — | — | | — | | |||||||||
Issuance of common stock related to vested restricted stock units | | | ( | — | — | |||||||||
Net loss | — | — | — | ( | ( | |||||||||
Balance -June 30, 2023 | | | | ( | | |||||||||
Issuance of common stock and warrants in registered direct offering [3][7] | | | | — | | |||||||||
Issuance of common stock as consideration for licensing agreement [4] | | | | — | | |||||||||
Issuance of common stock in At the Market offering [5] | | | | — | | |||||||||
Warrant modification - incremental value (6) | — | — | | — | | |||||||||
Warrant modification - in issuance costs for registered direct offering (7) | — | — | ( | — | ( | |||||||||
Stock-based compensation | — | — | | — | | |||||||||
Net loss | — | — | — | ( | ( | |||||||||
Balance - September 30, 2023 | | $ | | $ | | $ | ( | $ | | |||||
[1]
[2]
[3]
[4] Shares issued as partial consideration for License Agreement with Formosa Pharmaceuticals Inc.
[5]
[6]
[7]
The accompanying notes are an integral part of these condensed financial statements.
5
EYENOVIA, INC.
Condensed Statements of Cash Flows
(unaudited)
For the Nine Months Ended | ||||||
September 30, | ||||||
| 2024 |
| 2023 | |||
Cash Flows From Operating Activities |
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Net loss | $ | ( | $ | ( | ||
Adjustments to reconcile net loss to net cash used in operating activities: |
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Stock-based compensation | | | ||||
Change in fair value of equity consideration payable | ( | — | ||||
Depreciation of property and equipment |
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Amortization of debt discount | | | ||||
Write-off of property and equipment | | — | ||||
Write-down of inventories to net realizable value | | | ||||
Provision for returned deferred clinical supplies | — | | ||||
Reacquisition of license rights |
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Non-cash rent expense |
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Changes in operating assets and liabilities: |
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Prepaid expenses and other current assets | | | ||||
License fee and expense reimbursement receivables | ( | | ||||
Deferred clinical supply costs | | ( | ||||
Inventories | ( | ( | ||||
Security and equipment deposits | |
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Accounts payable |
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Accrued compensation |
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Accrued expenses and other current liabilities |
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Lease liabilities | ( | ( | ||||
Net Cash Used In Operating Activities |
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Cash Flows From Investing Activities | ||||||
Purchases of property and equipment | ( | ( | ||||
Investment in intangible asset | — | ( | ||||
Net Cash Used In Investing Activities | ( | ( | ||||
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Cash Flows From Financing Activities |
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Proceeds from sale of common stock and warrants in offerings |
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Payment of offerings issuance costs | ( | ( | ||||
Proceeds from sale of common stock in At the Market Program |
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Payment of issuance costs for At the Market Program | ( | ( | ||||
Proceeds from exercise of stock options | — | | ||||
Proceeds from note payable to Avenue | — | | ||||
Payment of issuance costs for notes issued to Avenue | — | ( | ||||
Repayments of notes payable |
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Net Cash Provided By Financing Activities |
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Net Decrease in Cash and Cash Equivalents |
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Cash and Cash Equivalents - Beginning of Period | |
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Cash and Cash Equivalents - End of Period | $ | | $ | | ||
The accompanying notes are an integral part of these condensed financial statements.
6
EYENOVIA, INC.
Condensed Statements of Cash Flows, continued
(unaudited)
For the Nine Months Ended | ||||||
September 30, | ||||||
| 2024 |
| 2023 | |||
Supplemental Disclosure of Cash Flow Information: |
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Cash paid during the period for: |
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Interest | $ | | $ | | ||
Supplemental Disclosure of Non-Cash Investing and Financing Activities | ||||||
Purchase of insurance policy financed by note payable | $ | | $ | | ||
Accrual for intangible asset milestone obligation | $ | | $ | — | ||
Reclassification of deferred clinical supply costs to inventories | $ | | $ | — | ||
Right-of-use assets obtained in exchange for lease liabilities | $ | — | $ | | ||
Vendor deposits applied to purchases of property and equipment | $ | — | $ | | ||
Original issue discount on notes payable | $ | — | $ | | ||
Warrant modification and additional warrants - incremental value | $ | | $ | | ||
Issuance of common stock in consideration of licensing agreement | $ | — | $ | | ||
Cashless exercise of stock options | $ | — | $ | | ||
Common stock issued in consideration for licensing agreement | $ | | $ | — | ||
Common stock issued in consideration for reacquisition of licensing agreement | $ | | $ | — | ||
Issuance of common stock related to vested restricted stock units | $ | — | $ | | ||
The accompanying notes are an integral part of these condensed financial statements.
7
Note 1 – Business Organization, Nature of Operations and Basis of Presentation
Eyenovia, Inc. (“Eyenovia” or the “Company”) is an ophthalmic technology company developing and commercializing advanced products leveraging its proprietary Optejet topical ophthalmic medication dispensing platform. The Optejet is especially useful in the treatment of chronic front-of-the-eye diseases due to its ease of use, enhanced safety and tolerability, and potential for superior compliance versus standard eye drops. Together, these benefits may combine to produce better treatment options and outcomes for patients and providers. The company’s pre-NDA candidate, MicroPine, is being developed for pediatric progressive myopia, a global epidemic impacting hundreds of millions of children worldwide and representing a multi-billion-dollar addressable market. The company’s current commercial portfolio includes clobetasol propionate ophthalmic suspension, 0.05%, for post-surgical pain and inflammation, and Mydcombi® for mydriasis. Eyenovia has also secured licensing and development agreements for additional multi-billion-dollar indications where the Optejet may be advantageous, including dry eye.
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, 2024 and for the three and nine months ended September 30, 2024 and 2023. The results of operations for the three and nine months ended September 30, 2024 are not necessarily indicative of the operating results for the full year ending December 31, 2024 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, 2023 and for the year then ended, which were included in the Company’s Annual Report on Form 10-K for the year ended December 31, 2023, filed with the Securities and Exchange Commission (“SEC”) on March 18, 2024 (the “2023 Form 10-K”), as amended by Amendment No. 1, filed with the SEC on April 26, 2024 (the “2023 Form 10-K Amendment”).
Note 2 – Summary of Significant Accounting Policies
The Company disclosed its significant accounting policies in Note 2 – Summary of Significant Accounting Policies included in the 2023 Form 10-K. There have been no material changes to the Company’s significant accounting policies during the nine months ended September 30, 2024, except as disclosed below.
Liquidity and Going Concern
As of September 30, 2024, the Company had unrestricted cash and cash equivalents of approximately $
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. As of September 30, 2024 and December 31, 2023, the Company had Treasury bills with original maturity dates of three months or less in the amounts of $
8
The Company has cash deposits in financial institutions that, at times, may be in excess of Federal Deposit Insurance Corporation (“FDIC”) insurance limits. The Company has not experienced losses in such accounts and periodically evaluates the creditworthiness of its financial institutions. As of September 30, 2024 and December 31, 2023, the Company had cash and cash equivalent balances in excess of FDIC insurance limits of $
Clinical Supply Arrangements
Bausch + Lomb Ireland Limited (“Bausch + Lomb”) and Arctic Vision had 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
Inventories
Inventories are stated at the lower of cost or net realizable value. Cost is determined using the first-in, first-out method. The cost of inventory that is sold commercially to third parties is included within cost of sales. The Company will periodically review for slow-moving, excess or obsolete inventories.
Inventory is primarily comprised of drug-device combination products, which are available for commercial sale, as follows:
| September 30, |
| December 31, | |||
| 2024 | 2023 | ||||
Finished goods | $ | | $ | | ||
Raw materials |
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Total inventory | $ | | $ | | ||
The Company has evaluated the net realizable value of the commercial inventory. The write-down of commercial inventory to net realizable value for the three months ended September 30, 2024 and 2023 was $
9
Net Loss Per Share of Common Stock
Basic net loss per share of common stock is computed by dividing net loss by the weighted average number of shares of common stock outstanding during the period, plus fully vested shares that are subject to issuance for little or no monetary consideration. Diluted loss per share reflects the potential dilution that could occur if securities or other instruments to issue common stock were exercised or converted into common stock. The following table presents the computation of basic and diluted net loss per common share:
| For the Three Months Ended | For the Nine Months Ended | ||||||||||
September 30, | September 30, | |||||||||||
| 2024 |
| 2023 |
| 2024 |
| 2023 | |||||
Numerator: | ||||||||||||
Net loss attributable to common stockholders | $ | ( | $ | ( | $ | ( | $ | ( | ||||
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Denominator (weighted average quantities): |
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Common shares issued |
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Add: Prefunded warrants |
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Add: Undelivered vested restricted shares |
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Denominator for basic and diluted net loss per share |
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Basic and diluted net loss per common share | $ | ( | $ | ( | $ | ( | $ | ( | ||||
The following securities are excluded from the calculation of weighted average diluted shares of common stock because their inclusion would have been anti-dilutive:
September 30, | ||||
| 2024 |
| 2023 | |
Warrants |
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Options |
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Convertible notes | | | ||
Restricted stock units |
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Total potentially dilutive shares |
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Subsequent Events
The Company has evaluated subsequent events through the date which the financial statements were issued. Based upon the evaluation, the Company did not identify any recognized or non-recognized subsequent events that would have required adjustment or disclosure in the financial statements, except as disclosed.
Recently Issued Accounting Standards
In November 2023, the FASB issued ASU 2023-07, Improvements to Reportable Segments Disclosures (Topic 280), which updates reportable segment disclosure requirements, primarily through enhanced disclosures about significant segment expenses on both an annual and interim basis. The guidance becomes effective for fiscal years beginning after December 15, 2023 and interim periods within fiscal years beginning after December 15, 2024, with early adoption permitted. Since this new ASU addresses only disclosures, the Company does not expect the adoption of this ASU to have any material effects on its financial condition, results of operations or cash flows. The Company is currently evaluating any new disclosures that may be required upon adoption of ASU 2023-07.
10
In December 2023, the FASB issued ASU 2023-09, Income Taxes (Topic 740): Improvements to Income Tax Disclosures. The amendments in this update address investor requests for more transparency about income tax information through improvements to income tax disclosures primarily related to the rate reconciliation and income taxes paid information. This update also includes certain other amendments to improve the effectiveness of income tax disclosures. The amendments in ASU 2023-09 are effective for fiscal years beginning after December 15, 2024, with early adoption permitted. The Company is currently evaluating the impact of this standard, but does not expect it to have a material impact on its financial statements.
Note 3 – Prepaid Expenses and Other Current Assets
As of September 30, 2024 and December 31, 2023, prepaid expenses and other current assets consisted of the following:
| September 30, |
| December 31, | |||
| 2024 |
| 2023 | |||
Prepaid insurance expenses | $ | | $ | | ||
Payroll tax receivable | | | ||||
Prepaid general and administrative expenses | | | ||||
Prepaid patent expenses |
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Prepaid conference expenses |
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Prepaid research and development expenses | | | ||||
Prepaid rent and security deposit |
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Other | | — | ||||
Total prepaid expenses and other current assets | $ | | $ | | ||
Note 4 - Intangible Assets
On August 15, 2023, the Company entered into a license agreement (the “Formosa License”) with Formosa Pharmaceuticals Inc. (“Formosa”), whereby the Company acquired the exclusive U.S. rights to commercialize any product related to a novel formulation of clobetasol propionate ophthalmic suspension,
11
Note 5 – Accrued Compensation
As of September 30, 2024 and December 31, 2023, accrued compensation consisted of the following:
| September 30, |
| December 31, | |||
| 2024 |
| 2023 | |||
Accrued bonus expenses | $ | | $ | | ||
Accrued payroll expenses |
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Total accrued compensation | $ | | $ | | ||
Note 6 – Accrued Expenses and Other Current Liabilities
As of September 30, 2024 and December 31, 2023, accrued expenses and other current liabilities consisted of the following:
| September 30, |
| December 31, | |||
| 2024 |
| 2023 | |||
Accrued intangible asset milestone obligation | $ | | $ | — | ||
Accrued defective clinical supply settlement, net | | | ||||
Accrued clinical studies costs | | — | ||||
Accrued professional services | | | ||||
Credit card payable | | | ||||
Accrued franchise tax | | — | ||||
Accrued research and development expenses | | | ||||
Other | | | ||||
Total accrued expenses and other current liabilities | $ | | $ | | ||
Note 7 – Notes Payable and Convertible Notes Payable
As of September 30, 2024 and December 31, 2023, notes payable and convertible notes payable consisted of the following:
September 30, 2024 |
| December 31, 2023 | ||||||||||||||||
| Notes Payable |
| Debt Discount |
| Net |
| Notes Payable |
| Debt Discount |
| Net | |||||||
Current portion: | ||||||||||||||||||
D&O insurance policy loan | $ | | $ | | $ | | $ | | $ | | $ | | ||||||
Avenue - Note payable | | ( | | | ( | | ||||||||||||
Avenue - Convertible note payable | | ( | | | | | ||||||||||||
Total current portion | $ | | $ | ( | $ | | $ | | $ | ( | $ | | ||||||
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Non-Current portion: |
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Avenue - Note payable | $ | | $ | | $ | | $ | | $ | ( | $ | | ||||||
Avenue - Convertible note payable | | ( | | | ( | | ||||||||||||
Total non-current portion | $ | | $ | ( | $ | | $ | | $ | ( | $ | | ||||||
On February 24, 2024, the Company issued a note payable in the amount of $
12
In June 2024, the Company began making principal payments related to that certain loan and security agreement (the “Loan and Security Agreement”) with Avenue Capital Management II, L.P. and related entities (together, “Avenue”) in the amount of $
During the three months ended September 30, 2024, the Company recorded interest expense of $
Note 8 – Commitments and Contingencies
Defective Clinical Supply
During the third quarter of 2023, a certain portion of clinical supply product sold by the Company to Bausch + Lomb was determined to be defective. On April 23, 2024, the Company and Bausch + Lomb executed a letter agreement (the “Side Letter”) pursuant to which the Company and Bausch + Lomb agreed that the Company would pay approximately $
Bausch License Agreements
On October 9, 2020, the Company entered into a license agreement (the Bausch License Agreement”), pursuant to which Bausch + Lomb was permitted to develop and commercialize the Bausch Licensed Product (as defined in the Bausch License Agreement) in the United States and Canada (the “Licensed Territory”). Bausch + Lomb could terminate the Bausch License Agreement, with respect to the Bausch Licensed Product to either country in the Licensed Territory, at any time for convenience upon
On January 12, 2024, the Company and Bausch + Lomb entered into a mutual termination and reassignment agreement (the “Letter Agreement”), pursuant to which Eyenovia reacquired the rights to the Bausch Licensed Product. The terms of the agreement include the immediate transfer of the rights and the subsequent transfer of certain assets relating to the Bausch Licensed Product from Bausch + Lomb to the Company in exchange for cash and common stock consideration. In addition, under the terms of the Letter Agreement, the Company agreed to pay Bausch + Lomb a low single-digit royalty on its net sales of the Bausch Licensed Product in the United States and Canada for a period of ten years from the date of the first commercial sale by the Company (or its affiliates or licensees) of the Bausch Licensed Product in the United States. Under the Letter Agreement, (i) the Company will re-acquire any and all licenses and other rights granted by the Company to Bausch + Lomb under the original Bausch License Agreement, (ii) any and all licenses and other rights granted by Bausch + Lomb to the Company under the License Agreement are terminated, other than as set forth in the Letter Agreement, and (iii) other than as set forth in the Letter Agreement, Bausch + Lomb is released from all of their ongoing obligations under the License Agreement, including development and commercialization obligations.
Pursuant to the Letter Agreement, the Company paid Bausch + Lomb an upfront payment of $
Pursuant to the Side Letter described above (see Defective Clinical Supply), the Company agreed to pay approximately $
13
recorded the payable to Bausch + Lomb in the amount of $
Operating Leases
A summary of the Company’s right-of-use assets and liabilities is as follows:
| For the Nine Months Ended September 30, | ||||||
2024 |
| 2023 | |||||
Cash paid for amounts included in the measurement of lease liabilities: |
|
| |||||
Operating cash flows used in operating activities | $ | | $ | | |||
Right-of-use assets obtained in exchange for lease obligations |
|
| |||||
Operating leases | $ | — | $ | | |||
Weighted Average Remaining Lease Term (Years) |
|
| |||||
Operating leases |
| | |||||
Weighted Average Discount Rate |
|
| |||||
Operating leases |
| | % | | % | ||
Future minimum payments under the Company’s operating lease agreements are as follows:
For the Years Ending December 31, |
| Minimum Lease Payments | |
2024 | $ | | |
2025 |
| | |
2026 |
| | |
2027 |
| | |
Total future minimum lease payments |
| | |
Less: Imputed interest | ( | ||
Present value of lease liabilities |
| | |
Less: current portion |
| ( | |
Lease liabilities, non-current portion | $ | | |
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.
Note 9 – Related Party Transactions
The Company has an advisory service agreement with a member of the board of directors. The agreement calls for a monthly consulting fee of $
14
Note 10 – Stockholders’ Equity
Increase in Authorized Number of Shares of Common Stock
On June 12, 2024, at the Annual Shareholders’ Meeting, the Company proposed and the shareholders approved an increase in the authorized number of shares of the Company’s common stock from
Common Stock Issuances
Pursuant to the License and certain milestone achievements, the Company issued
On May 3, 2024, the Company issued Bausch + Lomb
At-The-Market Program
During the nine months ended September 30, 2024, the Company received approximately $
Offerings
Second Quarter Offering
On April 8, 2024, the Company entered into a securities purchase agreement (the “Purchase Agreement”) with a single fundamentals-based healthcare investor (the “Purchaser”), pursuant to which the Company agreed to sell, in a registered direct offering by the Company directly to the Purchaser (the “April Offering”),
Third Quarter Offerings
A summary of the offerings for the third quarter is presented below:
|
| Additional |
| Total | |||||||
Common Stock | Paid-In | Stockholders’ | |||||||||
| Shares |
| Amount |
| Capital |
| Equity | ||||
July Offering |
| | $ | | $ | | $ | | |||
August Offering |
| |
| |
| |
| | |||
September Offering |
| |
| |
|
| |
| | ||
| | $ | | $ | | $ | | ||||
July Offering and Warrant Amendment
On July 1, 2024, the Company closed on a registered direct offering (the “July Offering”) with certain institutional and accredited investors (the “July Investors”), pursuant to which the Company sold
15
In connection with the July Offering, the Company entered into warrant amendment agreements (the “Amendments”) with the holders of previously issued warrants (the “Prior Warrants”) to purchase up to an aggregate of
The aggregate gross proceeds to the Company from the July Offering were approximately $
August Offering
On August 21, 2024, the Company agreed to sell
September Offering
On September 30, 2024, the Company closed on a registered direct offering (the “September Offering”) with a certain purchaser, pursuant to which the Company sold to the purchaser
Warrants
The issuance date or modification date fair value of stock warrants issued or modified during the three and nine months ended September 30, 2024 and 2023 was determined using the Black Scholes method, with the following assumptions used:
| For the Three Months Ended | For the Nine Months Ended |
| ||||||
September 30, | September 30, |
| |||||||
| 2024 |
| 2023 |
| 2024 |
| 2023 |
| |
Fair value of common stock on date of grant |
| $ | $ |
| $ | $ | |||
Risk free interest rate |
| ||||||||
Expected term (years) |
| ||||||||
Expected volatility |
| ||||||||
Expected dividends |
| n/a | n/a | n/a | n/a | ||||
16
A summary of the warrant activity during the nine months ended September 30, 2024 is presented below:
|
|
|
| Weighted | |||
Weighted | Average | ||||||
Average | Remaining | ||||||
Number of | Exercise | Life | |||||
| Warrants |
| Price |
| In Years | ||
Outstanding January 1, 2024 |
| | $ | |
|
| |
Granted (1) |
| |
| |
|
| |
Repriced - (Old) (2) |
| ( |
| |
|
| |
Repriced - (New) (2) |
| |
| |
|
| |
Exercised |
| — |
| — |
|
| |
Outstanding September 30, 2024 (1) |
| | $ | |
| ||
Exercisable September 30, 2024 (1) |
| | $ | |
| ||
(1) - Warrants granted, outstanding and exercisable exclude
(2) - Repriced warrants represent the reset of the exercise price of certain warrants to purchase
The following table presents information related to warrants as of September 30, 2024:
Warrants Outstanding (1) |
| Warants Exercisable (1) | ||||
Weighted | ||||||
Outstanding | Average | Exercisable | ||||
Exercise | Number of | Remaining Life | Number of | |||
Price |
| Warrants |
| In Years |
| Warrants |
$ |
| | (2) | — |
| — |
$ |
| | (3) | — |
| — |
$ |
| |
|
| | |
$ |
| |
|
| | |
$ |
| |
|
| | |
| |
|
| | ||
(1) - Warrants outstanding and exercisable exclude
(2) - These warrants become exercisable on March 26, 2025.
(3) - These warrants become exercisable on January 1, 2025.
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, 2024 and 2023, the Company recorded stock-based compensation expense of $
17
Restricted Stock Units
A summary of the restricted stock units (“RSUs”) activity during the nine months ended September 30, 2024 is presented below:
Weighted | |||||
Average | |||||
Number of | Exercise | ||||
| RSUs |
| Price | ||
RSUs non-vested January 1, 2024 |
| | $ | | |
Granted |
| |
| | |
Vested |
| ( |
| | |
Forfeited |
| — |
| — | |
RSUs non-vested September 30, 2024 |
| | $ | | |
Vested RSUs undelivered September 30, 2024 |
| | $ | | |
To date, RSUs have only been granted to directors in accordance with the Company’s Amended and Restated 2018 Omnibus Stock Incentive Plan. The Company’s policy is not to deliver shares underlying the RSUs until a director’s termination of service.
As of September 30, 2024, there was $
Stock Options
A summary of the option activity during the nine months ended September 30, 2024 is presented below:
|
|
|
|
| Weighted |
|
| |||
| Weighted |
| Average | |||||||
| Average |
| Remaining |
| Aggregate | |||||
| Number of |
| Exercise |
| Life |
| Intrinsic | |||
| Options |
| Price |
| In Years |
| Value | |||
Outstanding, January 1, 2024 |
| | |
|
|
|
| |||
Granted |
| |
| |
|
|
|
| ||
Exercised |
| — |
| — |
|
|
|
| ||
Forfeited/Expired |
| ( | |
| ||||||
Outstanding, September 30, 2024 | | $ | | $ | | |||||
|
| |||||||||
Exercisable, September 30, 2024 |
| | $ | |
| $ | — | |||
The following table presents information related to stock options as of September 30, 2024:
Options Outstanding |
| Options Exercisable | |||||
| Weighted | ||||||
|
| Average |
| ||||
Exercise |
| Number of |
| Remaining Life |
| Number of | |
Price |
| Options |
| In Years |
| Options | |
$ |
| | — |
| — | ||
$ |
| |
| | |||
$ |
| |
| | |||
$ |
| |
| | |||
$ |
| |
| | |||
$ |
| |
| | |||
$ |
| |
| | |||
$ | | | |||||
| |||||||
18
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, | |||||||||
| 2024 |
| 2023 |
| 2024 |
| 2023 | |||
Expected term (years) | |
| N/A | | | |||||
Risk free interest rate | N/A | |||||||||
Expected volatility | N/A | |||||||||
Expected dividends | N/A | |||||||||
As of September 30, 2024, there was $
Note 11 – 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. The Company’s Board of Directors approved a matching contribution equal to
During the three months ended September 30, 2024 and 2023, the Company recorded expense of $
Note 12 - Subsequent Events
Exercise of Pre-Funded Warrants
On October 1, 2024, the holder of the
19
Item 2. Management’s Discussion and Analysis of Financial Condition and Results of Operation
The following discussion and analysis of the results of operations and financial condition of Eyenovia, Inc. (“Eyenovia,” the “Company,” “we,” “us” and “our”) as of September 30, 2024 and for the three and nine months ended September 30, 2024 and 2023 should be read in conjunction with our unaudited condensed financial statements and the notes thereto included elsewhere in this Quarterly Report on Form 10-Q and with our audited financial statements and the notes thereto included in the 2023 Form 10-K, as amended by the 2023 Form 10-K Amendment.
Forward Looking Statements
This Quarterly Report on Form 10-Q contains “forward-looking statements” that involve risks and uncertainties, as well as assumptions that, if they never materialize or prove incorrect, could cause our results to differ materially from those expressed or implied by such forward-looking statements. The statements contained in this Quarterly Report on Form 10-Q that are not purely historical are forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended (the “Securities Act”), and Section 21E of the Securities Exchange Act of 1934, as amended (the “Exchange Act”). Such forward-looking statements include our estimates regarding expenses, future revenue, capital requirements and our need for additional financing and other financial items; any statements of the plans, strategies and objectives of management for future operations; any statements about the advantages of our product candidates and platform technology; estimates regarding the potential market opportunity for our product candidates and platform technology; statements regarding our clinical trials; factors that may affect our operating results; statements about our ability to establish and maintain intellectual property rights; statements about our ability to retain key personnel and hire necessary employees and appropriately staff our operations; statements related to future capital expenditures; statements related to future economic conditions or performance; and other matters that do not relate strictly to historical facts or statements of assumptions underlying any of the foregoing. Forward-looking statements are often identified by the use of words such as, but not limited to, “anticipate,” “believe,” “can,” “continue,” “could,” “estimate,” “expect,” “intend,” “may,” “might,” “will,” “plan,” “project,” “seek,” “should,” “target,” “would,” and similar expressions or variations intended to identify forward-looking statements. These statements are based on the beliefs and assumptions of our management based on information currently available to management. Such forward-looking statements are subject to risks, uncertainties and other important factors that could cause actual results and the timing of certain events to differ materially from future results expressed or implied by such forward – looking statements. Factors that could cause or contribute to such differences include, but are not limited to, those discussed in the sections titled “Summary Risk Factors” and “Risk Factors” included in Item 1A of Part I of the 2023 Form 10-K, as amended by our 2023 Form 10-K Amendment, and the risks discussed in our other SEC filings. Furthermore, such forward-looking statements speak only as of the date of this Quarterly Report on Form 10-Q. Except as required by law, we undertake no obligation to update any forward-looking statements to reflect events or circumstances after the date of such statements.
Overview
We are an ophthalmic technology company developing and commercializing advanced products leveraging our proprietary Optejet topical ophthalmic medication dispensing platform. The Optejet is especially useful in the treatment of chronic front-of-the-eye diseases due to its ease of use, enhanced safety and tolerability, and potential for superior compliance versus standard eye drops. Together, these benefits may combine to produce better treatment options and outcomes for patients and providers. The company’s pre-NDA candidate, MicroPine, is being developed for pediatric progressive myopia, a global epidemic impacting hundreds of millions of children worldwide and representing a multi-billion-dollar addressable market. The company’s current commercial portfolio includes clobetasol propionate ophthalmic suspension, 0.05%, for post-surgical pain and inflammation, and Mydcombi® for mydriasis. Eyenovia has also secured licensing and development agreements for additional multi-billion-dollar indications where the Optejet may be advantageous, including dry eye.
The ergonomic and functional design of the Optejet allows for horizontal drug delivery and eliminates the need to tilt the head back or the manual dexterity to squeeze a bottle, to administer medications. Drug is delivered in a microscopic array of droplets faster than the blink reflex to help ensure instillation success. The precise delivery of a low-volume columnar spray by the Optejet device minimizes contamination risk with a non-protruding nozzle and self-closing shutter. In clinical trials, the Optejet has demonstrated that its targeted delivery achieves a high rate of successful administration, with 98% of sprays being accurately delivered upon first attempt compared to the established rate reported with traditional eye drops of approximately 50%.
20
A more physiologically appropriate volume of medication in the range of seven to nine microliters is delivered by the Optejet, which is approximately one-fifth of the 35 to 50 microliter dose typically delivered in a single eye drop. Lower volume of medication exposes the ocular surface to less active ingredient and preservatives, potentially reducing ocular stress and surface damage and improving tolerability. The lower volume also minimizes the potential for drug to enter systemic circulation, with the goal of avoiding some common side effects that are related to overdosing of the eye.
We are developing versions of the Optejet with on-board digital technology that records the date and time of each use. These data may be used to provide reminders via Bluetooth to smart devices and to allow healthcare practitioners to monitor usage. This information can then be used by practitioners and health care systems to measure treatment compliance and improve medical decision making. In this way, the Optejet could serve as an extension of the physician’s office by providing information that is not currently possible to collect except through the use of diaries.
We have also successfully expanded our manufacturing capabilities through a partnership with Coastline International, Inc. located in Tijuana, Mexico, as well as the construction of our new manufacturing facility in Reno, Nevada and the construction of our own fill and finish facility in Redwood City, California. The FDA approved the use of both Coastline International and our Redwood City facility for the production of Mydcombi cartridges, and the use of our Reno facility for the production of technical elements such as the base unit for the Optejet device.
MicroLine is our investigational pharmacologic treatment for presbyopia, a non-preventable, age-related hardening of the lens, which causes the gradual loss of the eye’s ability to focus on near objects and impairs near visual acuity. We have completed two Phase III studies using our Optejet device. In these studies, patients reported high satisfaction with using the device, and a strong preference over using an eye dropper bottle. Since completing these studies, the market opportunity has markedly deteriorated, and we have chosen to put this program on hold and reallocate our resources towards larger opportunities. When and if the market improves, we have kept open the option to continue development of MicroLine which would include a meeting with the FDA to review our clinical data to date.
Mydcombi is the only FDA-approved fixed combination of the two leading mydriatic agents, tropicamide and phenylephrine in the United States and our first FDA-approved product. As an ophthalmic spray delivered with Optejet technology, Mydcombi may present a number of benefits for ophthalmic surgical centers, optometric and ophthalmic offices and patients. Those benefits may include improved cost-effectiveness in centers that employ single-use bottles for mydriasis, more efficient use of office time and resources, and an overall improved doctor-patient experience. We have begun the commercialization of Mydcombi, with the first commercial sale of the product occurring on August 3, 2023 as part of a targeted launch, expanded our launch with the hiring and onboarding of ten sales representatives through September 30, 2024. We received FDA approval for our primary Mydcombi manufacturing facility in February 2024, which we believe will allow us to expand and continue to build our manufacturing operations. On July 24, 2024, we received written comments from the FDA outlining the design of a clinical bridging study to transition Mydcombi into our new Gen-2 Optejet device, which has a significantly lower cost to manufacture than the currently approved product.
We are in active discussions with manufacturers of existing and late-stage ophthalmic medications to explore whether development with the Optejet technology can solve unmet medical and business needs. Some of those business needs could include extension of exclusivity under the Optejet patents, improvement in a drug’s tolerability profile, or potential improvement in treatment compliance.
On August 15, 2023, we entered into a license agreement with Formosa, whereby we acquired the exclusive U.S. rights to commercialize any product related to a novel formulation of clobetasol propionate ophthalmic suspension 0.05% (the “Formosa Licensed Product”), which was approved by the FDA, for post-operative inflammation and pain after ocular surgery, on March 4, 2024. The Formosa License will remain in effect for ten years from the date of the first commercial sale of a Formosa Licensed Product, unless earlier terminated.
21
We paid Formosa an upfront payment in an aggregate amount of $2.0 million which consisted of (a) cash in the amount of $1.0 million and (b) 487,805 shares of common stock valued pursuant to the Formosa License Agreement at $1.0 million. We also capitalized $122,945 of transaction costs in connection with the Formosa License. In addition, we agreed to pay Formosa up to $4.0 million upon the achievement of certain development milestones and up to $80 million upon the achievement of certain sales milestones. The trigger for the initial $2.0 million development milestone payment was FDA approval of the Formosa Licensed Product and the effective date of the acceptance by the Company of the transfer and assignment of the FDA approval, which occurred on March 14, 2024. Based on the achievement of this milestone, we paid Formosa (a) cash in the amount of $1.0 million on April 26, 2024 and (b) 613,496 shares of common stock (calculated pursuant to the Formosa License Agreement at $1.0 million using a five-day volume-weighted average price on March 14, 2024, but valued at $0.4 million on the April 29, 2024 settlement date). The remaining $2.0 million development milestone (to be fully paid in cash) was earned and accrued upon FDA approval, but payment will be triggered on the earlier of twelve months after FDA approval of the Formosa Licensed Product or six months following the first commercial sale of the Formosa Licensed Product.
On July 23, 2024, we entered into a collaboration agreement with Senju, under which the companies intend to work to develop EYEN-520, a combination of Senju’s corneal epithelial wound healing candidate with our Optejet dispensing technology, as a potential treatment for chronic dry eye disease. The companies plan to request a meeting with the FDA in late 2024, to be followed by execution of a definitive agreement related to the further development of the product and anticipated completion of a Phase 2b study in 2025. If successful, the collaboration agreement could be expanded to bring the product into two Phase 3 studies by 2026.
On August 7, 2024, we entered into a collaboration agreement with Formosa under which the companies intend to work to develop EYEN-530, a combination of Formosa’s clobetasol propionate ophthalmic solution with our Optejet dispensing technology, as a potential treatment for acute dry eye flare-ups. The companies plan to request a meeting with the FDA in late 2024, to be followed by execution of a definitive agreement related to further development of the product and anticipated initiation of two Phase 3 studies by 2026.
On September 26, 2024, we announced the U.S. launch and commercial availability of clobetasol propionate ophthalmic suspension 0.05%.
On September 18, 2024, we received notice from the Staff of Nasdaq providing notification that the Company’s bid price had closed below the $1.00 minimum bid price requirement for continued listing on Nasdaq under Listing Rule 5550(a)(2). The notification letter stated that we would be provided 180 calendar days to regain compliance. In order to regain compliance, the closing bid price of our common stock has to be at least $1.00 for a minimum of 10 consecutive business days at any time before March 17, 2025. As of November 11, 2024 the Company has not regained compliance with Listing Rule 5550(a)(2).
Historically, we have financed our operations principally through equity offerings. We have also generated cash through licensing arrangements and our credit facilities with Leerink Partners and Avenue. However, based upon our current operating plan, there is substantial doubt about our ability to continue as a going concern for at least one year from the date that our financial statements were issued. Our ability to continue as a going concern depends on our ability to complete additional licensing or business development transactions or raise additional capital through the sale of equity or debt securities to support our future operations. If we are unable to secure additional capital, we may be required to curtail our research and development initiatives and/or take additional measures to reduce costs.
Our net losses were $7.9 million and $7.3 million for the three months ended September 30, 2024 and 2023, respectively. As of September 30, 2024, we had a working capital deficit and an accumulated deficit of approximately $4.1 million and $175.4 million, respectively.
Financial Overview
Revenue and Cost of Revenue
Revenue is earned from the sale of our FDA approved products, primarily Mydcombi through September 30, 2024. The first commercial sale of FDA approved products occurred on August 3, 2023 as part of a targeted launch and we expanded our launch with the onboarding of ten sales representatives through September 30, 2024.
Cost of sales consists of the cost of the production of the FDA approved products that were sold and the write-down of inventories to net realizable value.
22
Research and Development Expenses
Research and development expenses are incurred in connection with the research and development of our microdose therapeutics and consist primarily of personnel-related expenses. Given where we are in our life cycle, we do not separately track research and development expenses by project. Our research and development expenses consist of:
| ● | direct clinical and non-clinical expenses, which include expenses incurred under agreements with contract research organizations, contract manufacturing organizations, and costs associated with preclinical activities, development activities and regulatory activities; |
| ● | personnel-related expenses, which include salaries and other compensation of employees that is attributable to research and development activities; and |
| ● | facilities and other expenses, which include direct and allocated expenses for rent and maintenance of facilities, insurance and other supplies used in research and development activities. |
We expense research and development costs as incurred. We record costs for some development activities, such as clinical trials, based on an evaluation of the progress to completion of specific tasks using data such as subject enrollment, clinical site activations or other information our vendors provide to us.
Our research and development expenses may increase with the continuation of these initiatives and the expansion of development of our Optejet technology functionality, drug compounds and indications.
Selling, General and Administrative Expenses
Selling, general and administrative expenses consist primarily of payroll and related expenses, legal and other professional services, insurance expense, marketing expense, and non-cash stock-based compensation expense. We anticipate that our selling, general and administrative expenses will increase in the future as we increase our headcount to support our continued research and development and the commercialization of our approved products and current and future product candidates.
Reacquisition of License Rights
Reacquisition of license rights consists of the expense related to the payments that we are required to pay Bausch + Lomb in connection with the reacquisition of the Bausch Licensed Product.
Other Income (Expense), Net
Other income (expense), net consists of (a) other income (expense) related to our sales of clinical supply to our licensees; (b) changes in fair value of equity consideration (the equity payable for the Bausch + Lomb and Formosa transactions); (c) interest income earned on Treasury bills; and (d) interest expense incurred on our indebtedness.
Results of Operations
Three Months Ended September 30, 2024 Compared with Three Months Ended September 30, 2023
Revenue and Cost of Revenue
Revenue for the three months ended September 30, 2024 totaled $1,625, which consisted primarily of revenue from the sale of Mydcombi and was offset by cost of revenues of $132,522. Write-down of inventories to net realizable value for the three months ended September 30, 2024 totaled approximately $0.1 million, compared to $12,218 for the three months ended September 30, 2023. The gross loss was primarily due to write-downs of commercial inventory that were still on the balance sheet at September 30, 2024.
Revenue for the three months ended September 30, 2023 totaled $1,198, which was offset by cost of revenues of $13,416. We expect to continue to generate negative gross margins on Gen 1 Mydcombi sales during the early stage of commercialization of this product and may experience negative overall gross margins until the commercialization of other products that may generate positive gross margins.
23
Research and Development Expenses
Research and development expenses for the three months ended September 30, 2024 totaled $3.5 million, a decrease of $0.1 million, or 3%, compared to $3.6 million recorded for the three months ended September 30, 2023. Research and development expenses consisted of the following:
For the Three Months Ended September 30, | ||||||
| 2024 |
| 2023 | |||
Personnel-related expenses | $ | 1,765,852 | $ | 1,716,355 | ||
Direct clinical and non-clinical expenses | 610,404 | 269,471 | ||||
Depreciation expense | 289,003 | 316,674 | ||||
Facilities expenses | 205,958 | 333,114 | ||||
Non-cash stock-based compensation expenses |
| 179,776 |
| 235,731 | ||
Other expenses |
| 89,594 |
| 21,070 | ||
Supplies and materials |
| 331,352 |
| 685,698 | ||
Total research and development expenses | $ | 3,471,939 | $ | 3,578,113 | ||
The decrease in supplies and materials expense was primarily due to a net overall decrease in related requirements due to the timing of Gen 1.0 and Gen 2.0 clinical production scale up and clinical testing. The increase in direct clinical and non-clinical expenses was primarily due to increased costs related to the reacquisition of the CHAPERONE study from Bausch + Lomb, Mydcombi stability testing and clinical regulatory expenses. The decrease in facilities expenses was due to costs incurred in 2023 related to getting the new Reno facility online that were not incurred in 2024. The decrease in non-cash stock-based compensation expenses was primarily due to the ending of the amortization period for older equity grants and terminations during the period. The increase in other expenses was primarily due to increased IT expenses related to CHAPERONE data tracking and cybersecurity.
Selling, General and Administrative Expenses
Selling, general and administrative expenses for the three months ended September 30, 2024 totaled $3.7 million, an increase of $0.8 million, or 27%, compared to $2.9 million recorded for the three months ended September 30, 2023. Selling, general and administrative expenses consisted of the following:
| For the Three Months Ended September 30, | |||||
2024 |
| 2023 | ||||
Salaries and benefits | $ | 1,610,533 | $ | 963,634 | ||
Professional fees |
| 719,239 |
| 715,832 | ||
Non-cash stock based compensation |
| 273,222 |
| 377,238 | ||
Sales and marketing |
| 169,377 |
| 190,915 | ||
Other |
| 239,081 |
| 89,191 | ||
Insurance expense |
| 212,783 |
| 224,645 | ||
Travel, lodging and meals | 161,659 | 57,707 | ||||
Facilities expense | 127,173 | 111,388 | ||||
Investor relations |
| 118,524 |
| 102,430 | ||
Director fees and expense |
| 97,500 |
| 96,875 | ||
Total selling, general and administrative expenses | $ | 3,729,091 | $ | 2,929,855 | ||
The increase in personnel-related expenses was mainly due to new staff additions made to support commercialization during 2024. The increase in other expenses is primarily due to commercial regulatory costs for Mydcombi and software licensing fees in connection with new staff additions. The decrease in non-cash stock-based compensation expenses was primarily due to the ending of the amortization period for older equity grants. The increase in travel, lodging and meals was primarily due to increased travel by the sales team to promote our FDA approved products.
Total Other Expense
Total other expense for the three months ended September 30, 2024 was approximately $0.6 million, a decrease of $0.2 million, compared to $0.8 million for the three months ended September 30, 2023. Total other expense for the three months ended September 30, 2024 primarily consisted of approximately $0.6 million of interest expense related to the Avenue loan.
24
Results of Operations
Nine Months Ended September 30, 2024 Compared with Nine Months Ended September 30, 2023
Revenue and Cost of Revenue
Revenue for the nine months ended September 30, 2024 totaled $29,243, which was offset by cost of revenues of $825,910. Write-down of inventories to net realizable value for the nine months ended September 30, 2024 totaled approximately $0.8 million, compared to $12,218 for the nine months ended September 30, 2023. The $0.8 million was comprised of the adjustment to bring the inventory to list price and an additional write-down of short-dated inventory to net realizable value. The gross loss was primarily due to write-downs of commercial inventory that were still on the balance sheet at September 30, 2024.
Revenue for the nine months ended September 30, 2023 totaled $1,198, which was offset by cost of revenues of $13,416. We expect to continue to generate negative gross margins on Gen 1 Mydcombi sales during the early stage of commercialization of this product and may experience negative overall gross margins until the commercialization of other products that may generate positive gross margins.
Research and Development Expenses
Research and development expenses for the nine months ended September 30, 2024 totaled $12.5 million, an increase of $3.6 million, or 40%, compared to $8.9 million recorded for the nine months ended September 30, 2023. Research and development expenses consisted of the following:
For the Nine Months Ended September 30, | ||||||
| 2024 |
| 2023 | |||
Personnel-related expenses | $ | 5,523,650 | $ | 5,078,228 | ||
Direct clinical and non-clinical expenses | 2,641,136 | 547,697 | ||||
Supplies and materials |
| 1,812,674 |
| 1,197,692 | ||
Depreciation expense |
| 914,172 |
| 537,528 | ||
Facilities expenses |
| 652,531 |
| 828,111 | ||
Non-cash stock-based compensation expenses | 618,516 | 647,058 | ||||
Other expenses |
| 338,034 |
| 74,810 | ||
Total research and development expenses | $ | 12,500,713 | $ | 8,911,124 | ||
The increase in direct clinical and non-clinical expenses was primarily due to increased clinical regulatory expenses incurred in connection with the reacquisition of the Bausch + Lomb license and Mydcombi stability testing. The increase in supplies and materials expense was primarily due to the expensing of Gen-1 MicroPine clinical product and materials that will now be used in Eyenovia-led clinical trials rather than being sold to Bausch + Lomb as a result of the reacquisition of the Bausch Licensed Product; drug formulation engineering batches related to Gen 2.0 specific formulations and future Mydcombi production. The increase in personnel-related expenses was primarily due to new staff additions made to support commercialization during the last two quarters of 2023 and the first quarter of 2024. The increase in depreciation expense was primarily due to increased equipment purchases and equipment placed in service during the last two quarters of 2023 and the first and second quarters of 2024. The increase in other expenses was primarily due to increased IT expenses related to CHAPERONE data tracking and cybersecurity. The decrease in facilities expenses was due to costs incurred in 2023 related to getting the new Reno facility online that were not incurred in 2024.
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Selling, General and Administrative Expenses
Selling, general and administrative expenses for the nine months ended September 30, 2024 totaled $11.1 million, an increase of $2.1 million, or 23%, compared to $9.0 million recorded for the nine months ended September 30, 2023. Selling, general and administrative expenses consisted of the following:
For the Nine Months Ended September 30, | ||||||
| 2024 |
| 2023 | |||
Salaries and benefits | $ | 4,594,448 | $ | 2,960,978 | ||
Professional fees |
| 2,248,900 |
| 2,108,656 | ||
Non-cash stock based compensation |
| 921,770 |
| 1,278,607 | ||
Sales and marketing |
| 618,946 |
| 588,051 | ||
Insurance expense |
| 642,499 |
| 708,639 | ||
Travel, lodging and meals |
| 399,142 |
| 179,615 | ||
Facilities expense | 376,127 | 359,057 | ||||
FDA PDUFA fees | 361,091 | — | ||||
Investor relations |
| 347,148 |
| 309,106 | ||
Director fees and expense |
| 311,250 |
| 300,625 | ||
Other expenses | 303,794 | 223,216 | ||||
Total selling, general and administrative expenses | $ | 11,125,115 | $ | 9,016,550 | ||
The increase in personnel-related expenses was mainly due to new staff additions related to commercialization efforts made during the last two quarters of 2023 and throughout fiscal year 2024. The increase in regulatory expenses was primarily due to the FDA Prescription Drug User Fee Act (“PDUFA”) fees for Mydcombi. The decrease in non-cash stock-based compensation expenses was primarily due to the ending of the amortization period for older equity grants. The increase in travel, lodging and meals was primarily due to increased travel by the sales team to promote Mydcombi. The increase in professional fees was primarily due to the short-term need for temporary staff while in the process of hiring permanent employees. The increase in sales and marketing expenses was primarily due to samples initiatives for the Clobetasol launch in 2024. The increase in other expenses was primarily due to software licensing and public filing fees.
Reacquisition of License Rights
Reacquisition of license rights for the nine months ended September 30, 2024 totaled $4.9 million, compared to no expense for the nine months ended September 30, 2023. The $4.9 million is comprised of the aggregate $5.0 million of payments ($2.0 million of cash and $3.0 million settled in common stock) to Bausch + Lomb in connection with the reacquisition of the Bausch Licensed Product (which we are recording as an operating expense), partially offset by $0.1 million related to the repurchase of equipment.
Total Other Expense
Total other expense for the nine months ended September 30, 2024 was approximately $0.6 million, a decrease of $0.8 million, compared to $1.4 million for the nine months ended September 30, 2023. Total other expense for the nine months ended September 30, 2024 primarily consisted of approximately $2.0 million of interest expense related to the Avenue loan partially offset by $1.2 million of changes in fair value of equity consideration (the equity payable for the Bausch + Lomb and Formosa transactions) and $0.2 million of interest income, primarily from Treasury bills.
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Liquidity and Going Concern
We measure our liquidity in a number of ways, including the following:
September 30, | December 31, | |||||
| 2024 |
| 2023 | |||
Cash and Cash Equivalents | $ | 7,188,129 | $ | 14,849,057 | ||
Working (Deficit) Capital | $ | (4,093,399) | $ | 11,176,336 | ||
| ||||||
Notes Payable (Gross) | $ | 12,368,804 | $ | 15,637,500 | ||
Cash Flow
Since inception, we have experienced negative cash flows from operations and our operations have primarily been funded by proceeds from equity and debt financings.
Our net losses were $29.9 million and $19.3 million for the nine months ended September 30, 2024 and 2023, respectively. As of September 30, 2024, we had an accumulated deficit of approximately $175.4 million. As of September 30, 2024, we had a cash and cash equivalents balance of $7.2 million, a working capital deficit of $4.1 million and stockholders’ equity of $3.7 million. As of September 30, 2024 and December 31, 2023, we had $12.4 million and $15.6 million, respectively, of gross debt outstanding.
These conditions raise substantial doubt about our ability to continue as a going concern for at least one year from the date that the financial statements included elsewhere in this Quarterly Report on Form 10-Q were issued. Our financial statements do not include adjustments to the amounts and classification of assets and liabilities that may be necessary should we be unable to continue as a going concern. Our ability to continue as a going concern depends on our ability to raise additional capital through the sale of equity or debt securities to support our future operations and the potential for entering into collaborations with other companies to enhance or complement our product and service offerings, and to enable us to make principal and interest payments on our debt obligations in the near term, which will be necessary to avoid a default on such obligations. Our operating needs also include the planned costs to operate our business, including amounts required to fund research and development activities including clinical studies, working capital and capital expenditures. Our future capital requirements and the adequacy of our available funds will depend on many factors, including our ability to successfully commercialize our 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 further improve the marketability of our product and service offerings. If we are unable to secure additional capital, we may be required to curtail our research and development initiatives and take additional measures to reduce selling, general and administrative costs in order to conserve our cash.
During the nine months ended September 30, 2024 and 2023, our sources and uses of cash were as follows:
Net cash used in operating activities for the nine months ended September 30, 2024 was approximately $24.0 million, which includes cash used to fund a net loss of $29.9 million, reduced by $5.8 million of net non-cash expenses, plus $0.1 million of net cash generated from changes in the levels of operating assets and liabilities. Net cash used in operating activities for the nine months ended September 30, 2023 was $17.5 million, which includes cash used to fund a net loss of $19.3 million, reduced by $3.7 million of non-cash expenses, plus $2.0 million of cash used to fund changes in operating assets and liabilities.
Net cash used in investing activities for the nine months ended September 30, 2024 was approximately $0.2 million, which was primarily related to the purchase of property and equipment. Cash used in investing activities for the nine months ended September 30, 2023 was $3.8 million, which was related to $2.7 million for purchases of property and equipment and a $1.1 million cash investment in an intangible asset.
Net cash provided by financing activities for the nine months ended September 30, 2024 totaled approximately $16.5 million, which was primarily attributable to $14.2 million of net proceeds from the sale of common stock and warrants in offerings and, $6.0 million of net proceeds from the sale of common stock in our “at-the-market” offering pursuant to the Sales Agreement with Leerink Partners, partially offset by $3.8 million from the repayment of notes payable. Net cash provided by financing activities for the nine months ended September 30, 2023 totaled $19.2 million, which was attributable to $10.9 million of net proceeds received from a registered direct offering, $4.0 million of net proceeds from an at-the-market offering and $4.9 million of net proceeds from the additional tranche under the Loan and Security Agreement. This was slightly offset by the repayment of $0.6 million of notes payable in connection with the D&O Loan.
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Contractual Obligations and Commitments
During the next twelve months, we have commitments to pay (a) $5.7 million to settle our September 30, 2024 accounts payable, accrued expenses and other current liabilities, (b) $0.6 million relating to our non-cancelable operating lease commitments, and (c) $10.1 million of gross payments due under our notes payable, convertible notes payable (if not previously converted).
After the next twelve months we have commitments to pay (a) an additional $0.3 million related to our accrued expenses and other non-current liabilities, (b) $0.8 million relating to our non-cancelable operating lease commitments, and (c) $2.3 million of gross payments due in connection with notes payable and convertible notes payable (if not previously converted).
Risks and Uncertainties
The continuing worldwide implications of the war between Russia and Ukraine and the conflict in the Middle East remain difficult to predict at this time. The imposition of sanctions on Russia by the United States and other countries and counter sanctions by Russia, and the resulting economic impacts on oil prices and other materials and goods, could affect the price of materials used in the manufacture of our product candidates. If the price of materials used in the manufacturing of our product candidates increase, that would adversely affect our business and the results of our operations.
Off-Balance Sheet Arrangements
There are no off-balance sheet arrangements between us and any other entity that have, or are reasonably likely to have, a current or future effect on financial conditions, changes in financial conditions, revenues or expenses, results of operations, liquidity, capital expenditures or capital resources that is material to stockholders.
Critical Accounting Estimates
As described in Item 7 – Critical Accounting Estimates in our 2023 Form 10-K, as amended by our 2023 Form 10-K Amendment, we prepare our financial statements in accordance with U.S. GAAP, which require our management to make estimates that affect the reported amounts of assets, liabilities and disclosures of contingent assets and liabilities at the balance sheet dates, as well as the reported amounts of revenues and expenses during the reporting periods. To the extent that there are material differences between these estimates and actual results, our financial condition or results of operations would be affected. We base our estimates on our own historical experience and other assumptions that we believe are reasonable after taking account of our circumstances and expectations for the future based on available information. We evaluate these estimates on an ongoing basis.
We consider an accounting estimate to be critical if: (i) the accounting estimate requires us to make assumptions about matters that were highly uncertain at the time the accounting estimate was made, and (ii) changes in the estimate that are reasonably likely to occur from period to period or use of different estimates that we reasonably could have used in the current period, would have a material impact on our financial condition or results of operations. There are items within our financial statements that require estimation but are not deemed critical, as defined above.
Item 3. Quantitative and Qualitative Disclosures About Market Risk.
Smaller reporting companies such as Eyenovia are not required to provide the information required by this Item.
Item 4. Controls and Procedures.
Evaluation of Disclosure Controls and Procedures
As of the end of the period covered by this Quarterly Report on Form 10-Q, we carried out an evaluation, under the supervision and with the participation of our management, including our principal executive officer and principal financial and accounting officer, of the effectiveness of the design and operation of our disclosure controls and procedures as defined in Rules 13a-15(e) and 15d-15(e) of the Exchange Act.
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In designing and evaluating our disclosure controls and procedures, management recognizes that any disclosure controls and procedures, no matter how well designed and operated, can provide only reasonable assurance of achieving the desired control objectives. In addition, the design of disclosure controls and procedures must reflect the fact that there are resource constraints and that management is required to apply its judgment in evaluating the benefits of possible controls and procedures relative to their costs.
Based on their evaluation, our principal executive officer and principal financial and accounting officer concluded that, as of September 30, 2024, our disclosure controls and procedures were designed to, and were effective to, provide assurance at a reasonable level that the information we are required to disclose in reports that we file or submit under the Exchange Act is recorded, processed, summarized and reported within the time periods specified in SEC rules and forms, and that such information is accumulated and communicated to our management, including our principal executive officer and principal financial and accounting officer, as appropriate, to allow timely decisions regarding required disclosures as of September 30, 2024.
Changes in Internal Control over Financial Reporting
There has been no change in our internal control over financial reporting that occurred during the quarter ended September 30, 2024 that has materially affected, or is reasonably likely to materially affect, our internal control over financial reporting.
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PART II - OTHER INFORMATION
Item 1. Legal Proceedings.
We are not currently a party to any material legal proceedings. From time to time, we may become involved in legal proceedings arising in the ordinary course of our business. Regardless of outcome, litigation can have an adverse impact on us due to defense and settlement costs, diversion of management resources, negative publicity, reputational harm and other factors.
Item 1A. Risk Factors.
There have been no material changes to the risk factors set forth in Part I, Item 1A of our 2023 Form 10-K, as amended by our 2023 Form 10-K Amendment.
Item 2. Unregistered Sales of Equity Securities and Use of Proceeds.
Recent Sales of Unregistered Securities
None.
Purchases of Equity Securities by the Issuer and Affiliated Purchasers
None.
Item 3. Defaults Upon Senior Securities.
Not applicable.
Item 4. Mine Safety Disclosures.
Not applicable.
Item 5. Other Information.
Securities Trading Plans of Directors and Executive Officers
During the nine months ended September 30, 2024, none of our
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Item 6. Exhibits.
Exhibit | Incorporated by Reference from Filings as Noted Below (Unless | |||||||||
Number |
| Exhibit Description |
| Form |
| File No. |
| Exhibit |
| Filing Date |
3.1 | 8-K | 001-38365 | 3.1 | January 29, 2018 | ||||||
3.1.1 | Certificate of Amendment to the Third Amended and Restated Certificate of Incorporation | 8-K | 001-38365 | 3.1.1 | June 14, 2018 | |||||
3.2 | 8-K | 001-38365 | 3.1 | February 7, 2022 | ||||||
3.3 | Certificate of Amendment to the Third Amended and Restated Certificate of Incorporation | 8-K | 001-38365 | 3.1 | June 14, 2024 | |||||
4.1 | 8-K | 001-38365 | 4.1 | July 1, 2024 | ||||||
4.2 | ||||||||||
4.3 | Form of Pre-Funded Warrant 8 - K 001 - 38365 4.2 September 30, 2024 | |||||||||
10.1 | 8-K | 001-38365 | 10.1 | July 1, 2024 | ||||||
10.2 | 8-K | 001-38365 | 10.2 | July 1, 2024 | ||||||
10.3 | 8-K | 001-38365 | 10.3 | July 1, 2024 | ||||||
10.4 | Form of Securities Purchase Agreement, dated August 21, 2024 | 8-K | 001-38365 | 10.1 | August 22, 2024 | |||||
10.5 | 8-K | 001-38365 | 10.1 | September 3, 2024 | ||||||
10.6 | Form of Securities Purchase Agreement, dated September 26, 2024. | 8-K | 001-38365 | 10.1 | September 30, 2024 | |||||
10.7 | Form of Eyenovia, Inc. Inducement Stock Option Award Agreement | — | — | — | Filed herewith | |||||
10.8 | — | — | — | Filed herewith | ||||||
31.1 | — | — | — | Filed herewith | ||||||
31.2 | — | — | — | Filed herewith | ||||||
32.1* | — | — | — | Filed herewith | ||||||
32.2* | — | — | — | Filed herewith | ||||||
101.INS | Inline XBRL Instance Document - the instance document does not appear in the Interactive Data File because XBRL tags are embedded within the Inline XBRL document | — | — | — | Filed herewith | |||||
101.SCH | Inline XBRL Taxonomy Extension Schema Document | — | — | — | Filed herewith | |||||
101.CAL | Inline XBRL Taxonomy Extension Calculation Linkbase Document | — | — | — | Filed herewith | |||||
101.DEF | Inline XBRL Taxonomy Extension Definition Linkbase Document | — | — | — | Filed herewith | |||||
101.LAB | Inline XBRL Taxonomy Extension Label Linkbase Document | — | — | — | Filed herewith | |||||
101.PRE | Inline XBRL Taxonomy Extension Presentation Linkbase Document | — | — | — | Filed herewith | |||||
104 | Cover Page Interactive Data File - the cover page XBRL tags are embedded within the Inline XBRL document contained in Exhibit 101 | — | — | — | Filed herewith | |||||
* | This certification is deemed not filed for purpose of Section 18 of the Securities Exchange Act of 1934, as amended, or otherwise subject to the liability of that section, nor shall it be deemed incorporated by reference into any filing under the Securities Act of 1933. |
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SIGNATURES
Pursuant to the requirements of the Securities Exchange Act of 1934, the Registrant has duly caused this report to be signed on its behalf by the undersigned thereunto duly authorized.
| EYENOVIA, INC. | |
|
| |
Date: November 12, 2024 | By: | /s/ Andrew Jones |
|
| Andrew Jones |
|
| Chief Financial Officer |
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