Item 9A. Controls and Procedures
Item 9A. Controls and Procedures.
Evaluation of Disclosure Controls and Procedures
As of the end of the period covered by this Annual Report on Form 10-K, 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 Securities Exchange Act of 1934, as amended, or the Exchange Act.
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 his evaluation, our principal executive officer and principal financial and accounting officer concluded that, as of December 31, 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 December 31, 2024.
Management’s Report on Internal Control over Financial Reporting
Our management, including our principal executive officer and principal financial and accounting officer, is responsible for establishing and maintaining adequate internal control over financial reporting (as defined in Rules 13a-15(f) and 15d-15(f) under the Exchange Act). Internal control over financial reporting is a process designed to provide reasonable assurance regarding the reliability of financial reporting and the preparation of financial statements for external purposes in accordance with U.S. GAAP. Our internal control over financial reporting includes those policies and procedures that: (i) pertain to the maintenance of records that, in reasonable detail, accurately and fairly reflect the transactions and dispositions of our assets; (ii) provide reasonable assurance that transactions are recorded as necessary to permit preparation of financial statements in accordance with U.S. GAAP, and that our receipts and
82
expenditures are being made only in accordance with authorizations of our management and directors; and (iii) provide reasonable assurance regarding prevention or timely detection of unauthorized acquisition, use, or disposition of our assets that could have a material effect on the financial statements.
Under the supervision and with the participation of our management, including our principal executive officer and principal financial and accounting officer, we conducted an evaluation of the effectiveness of our internal control over financial reporting as of December 31, 2024, based on the Internal Control-Integrated Framework (2013) issued by the Committee of Sponsoring Organizations of the Treadway Commission (COSO) (2013 Framework). Based on this evaluation under the 2013 Framework, our principal executive officer and principal financial and accounting officer has concluded that our internal control over financial reporting was ineffective as of December 31, 2024.
Specifically, management’s conclusion was based on the following material weaknesses which existed as of December 31, 2024:
● We failed to properly design and implement effective controls over the accounting for certain significant and complex, non-routine transactions and events. Specifically, the Company failed to properly account for the fair value of common equity shares issued in relation to the consideration for licensing agreements and debt modification.
● We failed to properly design and implement effective controls over identifying and recording impairments of Right-of-Use (ROU) assets. Specifically, we determined that the controls designed to review and approve the impairment analysis for ROU assets were not adequately designed or operating effectively. This deficiency resulted from a lack of sufficient precision in our control activities to properly account for the impairment of ROU assets and to appropriately measure the impairment loss.
A material weakness is a control deficiency or combination of control deficiencies, that results in more than a remote likelihood that a material misstatement of the annual or interim financial statements will not be prevented or detected on a timely basis.
Notwithstanding the existence of the material weaknesses as described above, we believe that the financial statements in this Annual Report fairly present, in all material respects, our financial position, results of operations and cash flows as of the dates, and for the periods presented, in conformity with GAAP.
Remediation Plan
Our management is committed to taking further action and implementing necessary enhancements or improvements, including those necessary to address the material weaknesses cited above. However, the material weaknesses will not be considered remediated until the applicable controls operate for a sufficient period of time and management has concluded, through testing, that these controls are operating effectively.
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 December 31, 2024 that has materially affected, or is reasonably likely to materially affect, our internal control over financial reporting.
Attestation Report of Registered Public Accounting Firm
This Annual Report on Form 10-K does not include an attestation report of our independent registered public accounting firm due to an exemption for non-accelerated filers.
Item 9B. Other Information.
N o n e .
Item 9C. Disclosure Regarding Foreign Jurisdictions that Prevent Inspections
Not applicable.
83
PART III
Item 10 . Directors, Executive Officers, and Corporate Governance.
Information required by this Item concerning our directors is incorporated by reference from the sections captioned “Election of Directors” and “Corporate Governance Matters” contained either in our proxy statement related to the 2025 Annual Meeting of Stockholders (the “2025 Proxy Statement”) or an amendment to this Form 10-K, which we intend to file with the SEC within 120 days of the end of our fiscal year pursuant to General Instruction G(3) of Form 10-K.
The information required by this Item concerning our Audit Committee is incorporated by reference from the section captioned “Corporate Governance Matters —Board Committees—Audit Committee” contained in our 2025 Proxy Statement or an amendment to this Form 10-K.
We have adopted a code of business conduct and ethics relating to the conduct of our business by all of our employees, executive officers, and directors. The policy is posted on our website, www.eyenovia.com.
The information required by this Item concerning our executive officers is incorporated by reference from the section captioned “Executive Officers” contained in our 2025 Proxy Statement or an amendment to this Form 10-K.
The information required by this Item concerning compliance with Section 16(a) of the Exchange Act is incorporated by reference from the section captioned “Delinquent Section 16(a) Reports” contained in our 2025 Proxy Statement or an amendment to this Form 10-K.
Item 11. Executive Compensation.
The information required by this Item is incorporated by reference to the information under the sections captioned “Executive Compensation,” and “Director Compensation” contained in our 2025 Proxy Statement or an amendment to this Form 10-K.
84
Item 12. Security Ownership of Certain Beneficial Owners and Management and Related Stockholder Matters.
The following table provides information as of December 31, 2024 about our common stock that may be issued upon the exercise of options, warrants and rights under all of our existing equity compensation plans (including individual arrangements):
Equity Compensation Plan Information
Weighted-
average
Number of securities
Number of securities
exercise price
remaining available for
to be issued upon
of outstanding
future issuance under
exercise of
options,
equity compensation plans
outstanding options,
warrants and
(excluding securities
warrants, and rights
rights
reflected in column (a))
Plan Category
(a)
(b)
(c)
Equity compensation plans approved by security holders
2014 Equity Incentive Plan, as amended
8,889
$
280.41
—
Amended and Restated 2018 Omnibus Stock Incentive Plan
66,886
209.50
14,227
Equity compensation plans not approved by security holders
—
—
—
Total
75,775
$
217.82
14,227
The other information required by this Item is incorporated by reference to the information under the section captioned “Security Ownership of Certain Beneficial Owners and Management” contained in our 2025 Proxy Statement or an amendment to this Form 10-K.
Item 13. Certain Relationships and Related Transactions, and Director Independence.
The information required by this Item is incorporated by reference to the information under the section captioned “Certain Relationships and Related-Party Transactions” and “Corporate Governance Matters” contained in our 2025 Proxy Statement or an amendment to this Form 10-K.
Item 14. Principal Accounting Fees and Services.
The information required by this Item is incorporated by reference to the information under the section captioned “Audit Committee Report” contained in our 2025 Proxy Statement or an amendment to this Form 10-K.
85
PART IV
Item 15. Exhibits, Financial Statement Schedules.
(a) List of documents filed as part of this report:
1. Financial Statements:
The financial statements of the Company and the related reports of the Company’s independent registered public accounting firm thereon have been filed under Item 8 hereof.
2. Financial Statement Schedules:
None.
3. Exhibits Index
The following is a list of exhibits filed as part of this Annual Report on Form 10-K:
Incorporated by Reference from Filings as Noted Below (Unless
Otherwise Indicated)
Exhibit
Number
Exhibit Description
Form
File No.
Exhibit
Filing Date
3.1
Third Amended and Restated Certificate of Incorporation
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
3.1.2
Certificate of Amendment to the Third Amended and Restated Certificate of Incorporation
8-K
001-38365
3.1
June 14, 2024
3.1.3
Certificate of Amendment to the Third Amended and Restated Certificate of Incorporation
8-K
001-38365
3.1
January 31, 2025
3.2
Second Amended and Restated Bylaws
8-K
001-38365
3.1
February 7, 2022
4.1
Description of Securities
-
Filed herewith
4.2
Form of Class B Warrant Issued on March 24, 2020
8-K
001-38365
4.2
March 25, 2020
4.3
Warrant Amendment Agreement, dated June 28, 2024
8-K
001-38365
10.3
July 1, 2024
4.4
Form of Warrant Issued on May 7, 2021
8-K
001-38365
4.1
May 10, 2021
4.5
Form of Warrant Issued on July 1, 2024
8-K
001-38365
4.1
July 1, 2024
4.6
Form of Warrant Issued on September 30, 2024
8-K
001-38365
4.1
September 30, 2024
86
4 .7
Amendment No. 1 to Warrant Issued on September 30, 2024, dated December 9, 202 4
--
Filed herewith
4.8
Form of Warrant Issued on November 26, 2024
8-K
001-38365
4.1
November 26, 2024
4.9
Amendment No. 1 to Warrant Issued on November 26, 2024, dated December 9, 2024
-
Filed herewith
4.10
Form of Warrant Issued on December 9, 2024
8-K
001-38365
4.1
December 9, 2024
4.11
Form of Series A Warrant Issued on January 17, 2025
8-K
001-38365
4.1
January 16, 2025
4.12
Form of Series B Warrant Issued on January 17, 2025
8-K
001-38365
4.2
January 16, 2025
10.1
Exclusive License Agreement, dated March 18, 2015, between Eyenovia, Inc. and Senju Pharmaceutical Co., Ltd.
S-1
333-222162
10.1
December 19, 2017
10.1.1#
Amendment to the Exclusive License Agreement by and between Eyenovia, Inc. and Senju Pharmaceutical Co., Ltd., dated April 8, 2020
10-Q
001-38365
10.24
August 14, 2020
10.1.2#
Letter Agreement by and between Eyenovia, Inc. and Senju Pharmaceutical Co., Ltd., dated August 10, 2020
10-Q
001-38365
10.27
August 14, 2020
10.1.3#
Amendment No. 2 to the Exclusive License Agreement by and between Eyenovia, Inc. and Senju Pharmaceutical Co., Ltd., dated September 14, 2021
10-Q
001-38365
10.2
November 12, 2021
10.4#
License Agreement by and between Eyenovia, Inc. and Arctic Vision (Hong Kong) Limited, dated August 10, 2020
10-Q
001-38365
10.28
August 14, 2020
10.5#
Amendment No. 1 to License Agreement by and between Eyenovia, Inc. and Arctic Vision (Hong Kong) Limited, dated September 14, 2021
10-Q
001-38365
10.1
November 12, 2021
10.6#
Mutual Termination and Reassignment, dated January 12, 2024, by and between Eyenovia, Inc and Bausch + Lomb Ireland Limited
10-K
001-38365
10.38
March 18, 2024
10.8#
License Agreement, dated August 15, 2023, by and between Eyenovia, Inc. and Formosa Pharmaceuticals, Inc.
10-Q
001-38365
10.1
November 13, 2023
87
10.9
Loan and Security Agreement, dated November 22, 2022, by among Eyenovia, Inc., Avenue Capital Management II, L.P., Avenue Venture Opportunities Fund, L.P. and Avenue Venture Opportunities Fund II, L.P.
10-K
001-38365
10.30
March 31, 2023
10.10
Supplement to the Loan and Security Agreement, dated November 22, 2022, by among Eyenovia, Inc., Avenue Capital Management II, L.P., Avenue Venture Opportunities Fund, L.P. and Avenue Venture Opportunities Fund II, L.P.
10-K
001-38365
10.31
March 31, 2023
10.11
Subscription Agreement, dated November 22, 2022, by and among Eyenovia, Inc., Avenue Venture Opportunities Fund, L.P. and Avenue Venture Opportunities Fund II, L.P.
10-K
001-38365
10.32
March 31, 2023
10.15*#
Employment Agreement, dated July 26, 2022, by and between Eyenovia, Inc, and Michael Rowe
10-Q
001-38365
10.2
August 11, 2022
10.17*
Employment Agreement, dated December 19, 2022, by and between Eyenovia, Inc. and Bren Kern
10-K
001-38365
10.33
March 31, 2023
1 0.18*
Non-Employee Director Compensation Policy, as amended
10-Q
001-38365
10.1
November 14, 2022
10.19*
Eyenovia, Inc. 2014 Equity Incentive Plan, as amended
S-8
333-233278
10.14
August 14, 2019
10.20*
Form of Nonqualified Stock Option Agreement
S-8
333-233278
10.15
August 14, 2019
10.21*
Eyenovia, Inc. Amended and Restated 2018 Omnibus Stock Incentive Plan, as Amended
8-K
001-38365
10.1
June 27, 2023
10.22*
Form of Restricted Stock Unit Agreement
10-K/A
001-38365
10.34
May 1, 2023
10.23*
Form of Notice of Inducement Stock Option Grant
10-Q
001-38365
10.7
November 12, 2024
10.24*
Form of Indemnification and Advancement Agreement
10-Q
001-38365
10.8
November 12, 2024
10.25#
Amended and Restated Sales Agreement, dated December 30, 2024, by and between Eyenovia, Inc. and Chardan Capital Markets, LLC
8-K
001-38365
1.1
December 30, 2024
10.26
Inducement Letter, dated January 16, 2025
8-K
001-38365
10.1
January 16, 2025
88
19.1
Insider Trading Policy
--
Filed herewith
23.1
Consent of Marcum LLP
--
Filed herewith
31.1
Certification of the Principal Executive Officer and Principal Financial Officer Pursuant to Section 302 of the Sarbanes-Oxley Act of 2002
--
Filed herewith
32.1
Certification of the Principal Executive Officer Pursuant to Section 906 of the Sarbanes-Oxley Act of 2002
--
Filed herewith
32.2
Certification of the Principal Financial Officer pursuant to Section 906 of the Sarbanes-Oxley Act of 2002
--
Filed herewith
9 7.1
Policy Relating to Recovery of Erroneously Awarded Compensation
10-K
001-38365
March 18, 2024
101
Inline interactive data files pursuant to Rule 405 of Regulation S-T: (i) Balance Sheets as of December 31, 2024 and 2023; (ii) Statements of Operations for the Years Ended December 31, 2024 and 2023; (iii) Statements of Changes in Stockholders’ Equity for the Years Ended December 31, 2024 and 2023; (iv) Statements of Cash Flows for the Years Ended December 31, 2024 and 2023; and (v) Notes to Financial Statements
--
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
*
Management contract or other compensatory plan.
#
Certain confidential portions of this Exhibit were omitted by means of marking such portions with brackets (“[***]”) because the identified confidential portions (i) are not material and (ii) are the type of information that the Company treats as private or confidential.
Item 16. Form 10-K Summary.
None.
89
SIGNATURES
Pursuant to the requirements of Sections 13 or 15(d) 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: April 15, 2025
By:
/s/ Michael Rowe
Michael Rowe
Chief Executive Officer
(Principal Executive Officer)
Pursuant to the requirements of the Securities Exchange Act of 1934, this report has been signed by the following persons on behalf of the registrant and in the capacities and on the dates indicated.
Signature
Title
Date
/s/ Michael Rowe
Chief Executive Officer
April 15, 2025
Michael Rowe
(Principal Executive and Financial and Accounting Officer) and Director
/s/ Tsontcho Ianchulev
Director
April 15, 2025
Tsontcho Ianchulev
/s/ Rachel Jacobson
Director
April 15, 2025
Rachel Jacobson
/s/ Charles E. Mather IV
Director
April 15, 2025
Charles E. Mather IV
/s/ Ram Palanki
Director
April 15, 2025
Ram Palanki
/s/ Ellen Strahlman
Director
April 15, 2025
Ellen Strahlman
/s/ Michael Geltzeiler
Director
April 15, 2025
Michael Geltzeiler
90
EYENOVIA, INC.
INDEX TO FINANCIAL STATEMENTS
Page
Number
Years Ended December 31, 2024 and 2023
Report of Independent Registered Public Accounting Firm (PCAOB ID: 688)
F-2
Balance Sheets as of December 31, 2024 and 2023
F-3
Statements of Operations for the Years Ended December 31, 2024 and 2023
F-4
Statements of Changes in Stockholders’ (Deficiency) Equity for the Years Ended December 31, 2024 and 2023
F-5
Statements of Cash Flows for the Years Ended December 31, 2024 and 2023
F-6
Notes to Financial Statements
F-8
F-1
REPORT OF INDEPENDENT REGISTERED PUBLIC ACCOUNTING FIRM
To the Stockholders and Board of Directors of
Eyenovia, Inc .
Opinion on the Financial Statements
We have audited the accompanying balance sheets of Eyenovia, Inc. (the “Company”) as of December 31, 2024 and 2023, the related statements of operations, changes in stockholders’ (deficiency) equity and cash flows for each of the two years in the period ended December 31, 2024, and the related notes (collectively referred to as the “financial statements”). In our opinion, the financial statements present fairly, in all material respects, the financial position of the Company as of December 31, 2024 and 2023, and the results of its operations and its cash flows for each of the two years in the period ended December 31, 2024, in conformity with accounting principles generally accepted in the United States of America.
Explanatory Paragraph – Going Concern
The accompanying financial statements have been prepared assuming that the Company will continue as a going concern. As more fully described in Note 2, the Company has a significant working capital deficiency, has incurred significant losses and needs to raise additional funds to meet its obligations and sustain its operations. These conditions raise substantial doubt about the Company’s ability to continue as a going concern. Management’s plans in regard to these matters are also described in Note 2. The financial statements do not include any adjustments that might result from the outcome of this uncertainty.
Basis for Opinion
These financial statements are the responsibility of the Company’s management. Our responsibility is to express an opinion on the Company’s financial statements based on our audit s . We are a public accounting firm registered with the Public Company Accounting Oversight Board (United States) (“PCAOB”) and are required to be independent with respect to the Company in accordance with the U.S. federal securities laws and the applicable rules and regulations of the Securities and Exchange Commission and the PCAOB.
We conducted our audits in accordance with the standards of the PCAOB. Those standards require that we plan and perform the audits to obtain reasonable assurance about whether the financial statements are free of material misstatement, whether due to error or fraud. The Company is not required to have, nor were we engaged to perform, an audit of its internal control over financial reporting. As part of our audits we are required to obtain an understanding of internal control over financial reporting but not for the purpose of expressing an opinion on the effectiveness of the Company’s internal control over financial reporting. Accordingly, we express no such opinion.
Our audits included performing procedures to assess the risks of material misstatement of the financial statements, whether due to error or fraud, and performing procedures that respond to those risks. Such procedures included examining, on a test basis, evidence regarding the amounts and disclosures in the financial statements. Our audits also included evaluating the accounting principles used and significant estimates made by management, as well as evaluating the overall presentation of the financial statements. We believe that our audits provide a reasonable basis for our opinion.
Critical Audit Matters
Critical audit matters are matters arising from the current period audit of the financial statements that were communicated or required to be communicated to the audit committee and that: (1) relate to accounts or disclosures that are material to the financial statements and (2) involved our especially challenging, subjective, or complex judgments. We determined that there are no critical audit matters.
/s/ Marcum llp
Marcum llp
We have served as the Company’s auditor since 2017.
New York, NY
April 15, 2025
F-2
EYENOVIA, INC.
Balance Sheets
December 31,
2024
2023
Assets
Current Assets
Cash and cash equivalents
$
2,121,463
$
14,849,057
Inventories
—
109,798
Deferred clinical supply costs
—
4,256,793
License fee and expense reimbursements receivable
24,827
123,833
Security deposits, current
14,968
1,506
Prepaid expenses and other current assets
605,941
1,365,731
Total Current Assets
2,767,199
20,706,718
Property and equipment, net
—
3,374,384
Security deposits, non-current
182,200
197,168
Intangible assets
—
2,122,945
Operating lease right-of-use asset
718,360
1,666,718
Equipment deposits
—
711,441
Total Assets
$
3,667,759
$
28,779,374
Liabilities and Stockholders’ Equity
Current Liabilities:
Accounts payable
$
2,199,768
$
1,753,172
Accrued compensation
144,161
1,658,613
Accrued expenses and other current liabilities
3,178,513
287,928
Operating lease liabilities - current portion
575,163
501,250
Notes payable - current portion, net of debt discount of $ 527,870 and $ 503,914 as of December 31, 2024 and 2023, respectively
5,212,532
5,329,419
Convertible notes payable - current portion, net of debt discount of $ 263,930 and $ 0 as of December 31, 2024 and 2023, respectively
4,736,070
—
Total Current Liabilities
16,046,207
9,530,382
Operating lease liabilities - non-current portion
717,504
1,292,667
Notes payable - non-current portion, net of debt discount of $ 0 and $ 448,367 as of December 31, 2024 and 2023, respectively
—
4,355,800
Convertible notes payable - non-current portion, net of debt discount of $ 0 and $ 398,569 as of December 31, 2024 and 2023, respectively
—
4,601,431
Total Liabilities
16,763,711
19,780,280
Commitments and contingencies (Note 9)
Stockholders’ Equity:
Preferred stock, $ 0.0001 par value, 6,000,000 shares authorized; none issued and outstanding as of December 31, 2024 and 2023
Common stock, $ 0.0001 par value, 300,000,000 shares authorized; 1,506,369 and 569,409 shares issued and outstanding as of December 31, 2024 and 2023, respectively
151
57
Additional paid-in capital
182,213,889
154,490,596
Accumulated deficit
( 195,309,992 )
( 145,491,559 )
Total Stockholders’ Equity
( 13,095,952 )
8,999,094
Total Liabilities and Stockholders’ Equity
$
3,667,759
$
28,779,374
The accompanying notes are an integral part of these financial statements.
F-3
EYENOVIA, INC.
Statements of Operations
For the Years Ended
December 31,
2024
2023
Operating Income
Revenue
$
57,336
$
3,787
Cost of revenue
( 3,927,228 )
( 16,005 )
Gross Profit
( 3,869,892 )
( 12,218 )
Operating Expenses:
Research and development
14,462,722
12,975,832
Selling, general and administrative
14,333,114
12,418,396
Reacquisition of license rights
4,864,600
—
Asset impairments
11,207,897
—
Total Operating Expenses
44,868,333
25,394,228
Loss From Operations
( 48,738,225 )
( 25,406,446 )
Other (Expense) Income:
Other expense
( 90,601 )
( 176,411 )
Change in fair value of equity consideration payable
1,240,800
—
Interest expense
( 2,484,431 )
( 2,371,851 )
Interest income
254,024
693,612
Total Other Expense
( 1,080,208 )
( 1,854,650 )
Net Loss
$
( 49,818,433 )
$
( 27,261,096 )
Net Loss Per Share - Basic and Diluted
$
( 59.81 )
$
( 53.15 )
Shares Outstanding - Basic and Diluted
832,997
512,912
The accompanying notes are an integral part of these financial statements.
F-4
EYENOVIA, INC.
Statements of Changes in Stockholders’ (Deficiency) Equity
For the Years Ended December 31, 2024 and 2023
Additional
Total
Common Stock
Paid-In
Accumulated
Stockholders’
Shares
Amount
Capital
Deficit
(Deficiency) Equity
Balance - January 1, 2023
458,362
$
46
$
135,464,982
$
( 118,230,463 )
$
17,234,565
Issuance of common stock and warrants in registered direct offering [1][5]
52,482
5
10,886,109
—
10,886,114
Issuance of common stock as consideration for licensing agreement [2]
6,097
1
999,999
—
1,000,000
Exercise of pre-funded stock warrants
28,162
3
22,526
—
22,529
Issuance of common stock in At the Market Program [3]
23,326
2
4,591,890
—
4,591,892
Cashless exercise of stock options
259
—
—
—
—
Exercise of stock options
125
—
27,200
—
27,200
Stock-based compensation
—
—
2,497,890
—
2,497,890
Issuance of common stock related to vested restricted stock units
596
—
—
—
—
Warrant modification - incremental value [4]
—
—
1,738,700
—
1,738,700
Warrant modification - in issuance costs for registered direct offering [5]
—
—
( 1,738,700 )
—
( 1,738,700 )
Net loss
—
—
—
( 27,261,096 )
( 27,261,096 )
Balance - December 31, 2023
569,409
57
154,490,596
( 145,491,559 )
8,999,094
Issuance of common stock in At the Market Program [6]
70,381
7
6,047,362
—
6,047,369
Issuance of common stock as consideration for licensing agreement [7]
7,668
1
436,808
—
436,809
Issuance of common stock as consideration for reacquisition of licensing agreement [8]
28,742
3
2,322,388
—
2,322,391
Issuance of common stock and warrants in offerings [9]
653,493
66
17,011,256
—
17,011,322
Exercise of pre-funded stock warrants
152,905
15
1,208
—
1,223
Warrant modification and additional warrants - incremental value [10]
—
—
2,868,000
—
2,868,000
Warrant modification and additional warrants - in issuance costs for offering [11]
—
—
( 2,868,000 )
—
( 2,868,000 )
Issuance of common stock as consideration for modification of loan agreement
23,771
2
199,998
—
200,000
Stock-based compensation
—
—
1,704,273
—
1,704,273
Net loss
—
—
—
( 49,818,433 )
( 49,818,433 )
Balance - December 31, 2024
1,506,369
$
151
$
182,213,889
$
( 195,309,992 )
$
( 13,095,952 )
[1] Includes gross proceeds of $ 11,977,468 less total cash issuance costs of $ 1,091,354 .
[2] Shares issued as partial consideration for License Agreement with Formosa Pharmaceuticals Inc.
[3] Includes gross proceeds of $ 4,733,909 less total issuance costs of $ 142,017 .
[4] Warrant originally granted in the March 2022 offering was modified in connection with the registered direct offering
[5] Warrant modification in connection with registered direct offering accounted for as a non-cash issuance cost of the registered direct offering, but is presented on a separate line item for clarity.
[6] Includes gross proceeds of $ 6,234,402 less total issuance costs of $ 187,033 .
[7] Shares issued as partial consideration for License Agreement with Formosa Pharmaceuticals Inc.
[8] Shares issued as partial consideration for reversion of License Agreement with Bausch & Lomb Ireland Limited.
[9] Includes gross proceeds of $ 19,385,015 , less total cash issuance costs of $ 2,373,693 .
[10] Offering includes modification of warrants and additional warrants in the July 2024 offering.
[11] Non-cash warrant modification and additional warrants issuance costs related to one of the offerings are shown on a separate line item for clarity.
The accompanying notes are an integral part of these financial statements.
F-5
EYENOVIA, INC.
Statements of Cash Flows
For the Years Ended
December 31,
2024
2023
Cash Flows From Operating Activities
Net loss
$
( 49,818,433 )
$
( 27,261,096 )
Adjustments to reconcile net loss to net cash
used in operating activities:
Stock-based compensation
1,704,273
2,497,890
Change in fair value of equity consideration payable
( 1,240,800 )
—
Depreciation of property and equipment
1,128,449
783,208
Amortization of debt discount
759,049
681,860
Asset impairments
11,207,897
—
Write-down of inventories to net realizable value
3,085,450
12,218
Provision for returned clinical supplies
—
400,000
Reacquisition of license rights
2,864,600
—
Non-cash rent expense
528,359
529,311
Changes in operating assets and liabilities:
Prepaid expenses and other current assets
554,020
434,128
License fee and expense reimbursement receivables
99,006
1,059,953
Deferred clinical supply costs
868,328
( 2,271,862 )
Inventories
—
( 122,016 )
Security and equipment deposits
1,506
1,750
Accounts payable
446,596
324,889
Accrued compensation
( 1,514,452 )
( 88,578 )
Accrued expenses and other current liabilities
( 293,579 )
( 315,148 )
Lease liabilities
( 501,250 )
( 503,046 )
Net Cash Used In Operating Activities
( 30,120,981 )
( 23,836,539 )
Cash Flows From Investing Activities
Purchases of property and equipment
( 161,477 )
( 2,847,592 )
Investment in intangible asset
—
( 1,122,945 )
Net Cash Used In Investing Activities
( 161,477 )
( 3,970,537 )
Cash Flows From Financing Activities
Proceeds from sale of common stock and warrants in offerings [1] [2]
19,385,015
11,977,468
Payment of offerings issuance costs
( 2,373,693 )
( 1,091,354 )
Proceeds from sale of common stock in At the Market Program
6,234,402
4,733,909
Payment of issuance costs for At the Market Program
( 187,033 )
( 142,017 )
Proceeds from exercise of stock options
—
27,200
Proceeds from exercise of stock warrants
1,223
22,529
Proceeds from note payable and equity issued to Avenue
—
5,000,000
Payment of issuance costs for notes issued to Avenue
—
( 125,982 )
Repayments of notes payable
( 5,505,050 )
( 609,140 )
Net Cash Provided By Financing Activities
17,554,864
19,792,613
Net Decrease in Cash and Cash Equivalents
( 12,727,594 )
( 8,014,463 )
Cash and Cash Equivalents - Beginning of Period
14,849,057
22,863,520
Cash and Cash Equivalents - End of Period
$
2,121,463
$
14,849,057
The accompanying notes are an integral part of these financial statements.
F-6
EYENOVIA, INC.
Statements of Cash Flows, continued
For the Years Ended
December 31,
2024
2023
Supplemental Disclosure of Cash Flow Information:
Cash paid during the period for:
Interest
$
1,622,479
$
1,690,548
Supplemental Disclosure of Non-Cash Investing and Financing Activities
Purchase of insurance policy financed by note payable
$
505,050
$
609,140
Accrual for intangible asset milestone obligation
$
2,000,000
$
—
Reclassification of deferred clinical supply costs to inventories
$
2,975,652
$
—
Right-of-use assets and lease liabilities recognized upon lease renewal
$
—
$
904,437
Vendor deposits applied to purchases of property and equipment
$
—
$
14,885
Original issue discount on notes payable
$
—
$
212,500
Warrant modification and additional warrants - incremental value
$
2,868,000
$
1,738,700
Issuance of common stock as consideration for licensing agreement
$
—
$
1,000,000
Cashless exercise of stock options
$
—
$
2
Common stock issued as consideration for licensing agreement
$
436,809
$
—
Common stock issued as consideration for reacquisition of licensing agreement
$
2,322,391
$
—
Common stock issued in consideration for equipment received in conjunction with licensing agreement
$
( 135,400 )
$
—
Common stock issued as consideration for modification of loan agreement
$
200,000
$
—
Interest expense added to note principal
$
102,902
$
—
Issuance of common stock related to vested restricted stock units
$
—
$
4
[1] For 2023, includes gross proceeds of $ 11,977,468 , of which $ 4,168,011 is pre-funded warrants.
[2] For 2024, includes gross proceeds of $ 19,385,015 , of which $ 1,240,926 is pre-funded warrants.
The accompanying notes are an integral part of these financial statements.
F-7
EYENOVIA, INC.
NOTES TO THE FINANCIAL STATEMENTS
FOR THE YEARS ENDED DECEMBER 31, 2024 AND 2023
Note 1 – Business Organization, Nature of Operations and Basis of Presentation
Organization and Operations
Eyenovia, Inc., (“Eyenovia” or the “Company”) is an ophthalmic technology company developing a proprietary Optejet® topical ophthalmic medication dispensing platform. In November 2024, the Company received a negative clinical trial result in their development-stage drug-device combination product, MicroPine. As a result, the Company restructured, minimized expenses and engaged with an investment bank to explore strategic options in order to maximize shareholder value. The Company has paused the national sales roll-out of its products clobetasol propionate and Mydcombi® until additional funding can be obtained. At the same time, the Company accelerated development efforts relating to the Optejet.
Basis of Presentation
On January 31, 2025, the Company effected a reverse stock split of its common stock at a ratio of 1–for-80 (the “Reverse Split”). Accordingly, all share and per share amounts for all periods presented in these financial statements and notes thereto have been adjusted retroactively, where applicable, to reflect the Reverse Split and adjustment of the conversion price or exercise price of each outstanding equity award, convertible security and warrant as if the transaction had occurred as of the beginning of the earliest period presented (see Note 15 – Subsequent Events - Reverse Stock Split)
Note 2 – Summary of Significant Accounting Policies And Going Concern
Going Concern
As of December 31, 2024, the Company had unrestricted cash and cash equivalents of approximately $ 2.1 million and an accumulated deficit of approximately $ 195.3 million. For the years ended December 31, 2024 and 2023, the Company incurred net losses of approximately $ 49.8 million and $ 27.3 million, respectively, and used cash in operations of approximately $ 30.1 million and $ 23.8 million, respectively. The Company does not have recurring revenue and has not yet achieved profitability. The Company expects to continue to incur cash outflows from operations for the near future. These circumstances raise substantial doubt about the Company’s ability to continue as a going concern for at least one year from the date that these financial statements are issued. Implementation of the Company’s plans and its ability to continue as a going concern will depend upon the Company’s ability to generate sufficient recurring revenues, the Company’s ability to raise further capital, through the sale of additional equity or debt securities or the completion of a transaction consistent with the strategic alternatives that we are exploring 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 adequacy of its available funds will depend on many factors, including the Company’s ability to execute a strategic partnership or merger, ability to successfully commercialize its products and services, competing technological and market developments, and the need to enter into collaborations with other companies, or acquire other companies or technologies to enhance or complement its product and service offerings. If the Company is unable to generate sufficient recurring revenues or secure additional capital, it may be required to curtail its research and development initiatives, take additional measures to reduce costs in order to conserve its cash or file for bankruptcy.
Use of Estimates
Preparation of financial statements in conformity with accounting principles generally accepted in the United States of America, or U.S. GAAP, requires management to make estimates, judgments and assumptions that affect the amounts reported in the financial statements and the amounts disclosed in the related notes to the financial statements. The Company bases its estimates and judgments on historical experience and on various other assumptions that it believes are reasonable under the circumstances. The amounts of assets and liabilities reported in the Company’s balance sheets and the amounts of expenses reported for each of the periods presented are affected by estimates and assumptions, which are used for, but not limited to, fair value calculations for equity securities, establishment of valuation allowances for deferred tax assets, revenue recognition, the recoverability and useful lives of long-lived assets, the realization of inventories and deferred clinical supply costs, the recovery of deferred costs and the deferral of revenues. Certain of the Company’s estimates could be affected by external conditions, including those unique to the Company and general economic conditions. It is reasonably possible that actual results could differ from those estimates.
F-8
EYENOVIA, INC.
NOTES TO THE FINANCIAL STATEMENTS
FOR THE YEARS ENDED DECEMBER 31, 2024 AND 2023
See Note 2 - Summary of Significant Accounting Policies — Stock-Based Compensation for additional discussion of the use of estimates in estimating the fair value of the Company’s common stock.
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 December 31, 2024 and 2023, the Company had Treasury bills with original maturity dates of three months or less in the amount of $ 0 and $ 5,450,118 respectively.
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 December 31, 2024 and 2023, the Company had cash and cash equivalent balances in excess of FDIC insurance limits of $ 1,658,188 and $ 14,243,870 , respectively.
Property and Equipment, Net
Property and equipment are stated at cost, net of accumulated depreciation, amortization and impairments, which is recorded commencing at the in-service date using the straight-line method at rates sufficient to charge the cost of depreciable assets to operations over their estimated useful lives, which range from 1 to 10 years . Leasehold improvements are amortized over the lesser of (a) the useful life of the asset; or (b) the remaining lease term. Maintenance and repairs are charged to operations as incurred. The Company capitalizes costs attributable to the betterment of property and equipment when such betterment extends the useful life of the assets. Vendor deposits toward the purchase of property and equipment are reflected as equipment deposits on the accompanying balance sheets. The Company commences depreciation of assets when they are placed in service.
Impairment of Long-lived Assets
The Company reviews for the impairment of long-lived assets whenever events or changes in circumstances indicate that the carrying amount of an asset might not be recoverable. An impairment would be recognized when estimated future cash flows expected to result from the use of the asset and its eventual disposition are less than its carrying amount. The Company recorded $ 11,207,897 in impairment losses during the year ended December 31, 2024 , of which $ 9,797,198 was for the Company’s long-lived assets consisting of $ 6,122,945 of intangible assets, $ 3,254,254 of property and equipment, which includes $ 711,441 of equipment deposits, and $ 420,000 of operating lease right-of-use assets. The Company did not record any impairment losses during the year ended December 31, 2023.
Fair Value of Financial Instruments
The Company measures the fair value of financial assets and liabilities based on Accounting Standards Codification, or ASC Topic 820 “Fair Value Measurements and Disclosures”, or ASC 820, which defines fair value, establishes a framework for measuring fair value, and expands disclosures about fair value measurements.
ASC 820 defines fair value as the exchange price that would be received for an asset or paid to transfer a liability (an exit price) in the principal or most advantageous market for the asset or liability in an orderly transaction between market participants on the measurement date. ASC 820 also establishes a fair value hierarchy, which requires an entity to maximize the use of observable inputs and minimize the use of unobservable inputs when measuring fair value. ASC 820 describes three levels of inputs that may be used to measure fair value:
Level 1 — quoted prices in active markets for identical assets or liabilities;
Level 2 — quoted prices for similar assets and liabilities in active markets or inputs that are observable; and
Level 3 — inputs that are unobservable (for example, cash flow modeling inputs based on assumptions).
The carrying amounts of the Company’s financial instruments, such as cash and cash equivalents, restricted cash, accounts payable, and notes payable approximate fair values due to the short-term nature or effective interest rates of these instruments.
F-9
EYENOVIA, INC.
NOTES TO THE FINANCIAL STATEMENTS
FOR THE YEARS ENDED DECEMBER 31, 2024 AND 2023
Income Taxes
The Company is subject to Federal, New York State and City, and State of California income taxes and files tax returns in those jurisdictions.
The Company recognizes deferred tax assets and liabilities for the expected future tax consequences of items that have been included or excluded in the financial statements or tax returns. Deferred tax assets and liabilities are determined on the basis of the difference between the tax basis of assets and liabilities and their respective financial reporting amounts, or temporary differences, at enacted tax rates in effect for the years in which such temporary differences are expected to reverse.
The Company utilizes a recognition threshold and measurement process for financial statement recognition and measurement of a tax position taken or expected to be taken in a tax return.
The Company’s policy is to classify assessments, if any, for tax-related interest as interest expense and penalties as selling, general and administrative expenses in the statements of operations.
Revenue Recognition
The Company’s revenues are generated primarily through product sales or 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 the Company under these arrangements typically include one or more of the following: non-refundable, upfront license fees; milestone payments; payments for clinical product supply, and royalties on future product sales.
The Company analyzes its arrangements to assess whether such arrangements involve joint operating activities. For collaboration arrangements that are deemed to be within the scope of ASC Topic 808, “Collaborative Arrangements”, or ASC 808, the Company allocates the contract consideration between such joint operating activities and elements that are reflective of a vendor-customer relationship and, therefore, within the scope of ASC Topic 606, “Revenue from Contracts with Customers”, or ASC 606. The Company’s policy is to recognize amounts allocated to joint operating activities as a reduction in research and development expense.
Under ASC 606, the Company recognizes revenue when its customers obtain control of promised goods or services, in an amount that reflects the consideration the Company expects to receive in exchange for those goods or services. To determine revenue recognition for arrangements that the Company determines are within the scope of ASC 606, the Company performs the following five steps:
● Step 1: Identify the contract with the customer;
● Step 2: Identify the performance obligations in the contract;
● Step 3: Determine the transaction price;
● Step 4: Allocate the transaction price to the performance obligations in the contract; and
● Step 5: Recognize revenue when the company satisfies a performance obligation.
During the years ended December 31, 2024 and 2023, the Company recognized revenue primarily from the following type of contract:
Product sales – Revenue is recognized at the point in time the customer obtains control of the goods and the Company satisfies its performance obligation, which is generally at the time it ships the product to the customer.
The Company must make significant judgments in its revenue recognition process, including identifying performance obligations in the contract, estimating the amount of variable consideration to include in the transaction price and allocating the transaction price to each performance obligation. Milestone payments represent variable consideration that will be recognized when the performance obligation is achieved. Sales-based royalty payments derived from usage of intellectual property are recognized when those sales occur.
F-10
EYENOVIA, INC.
NOTES TO THE FINANCIAL STATEMENTS
FOR THE YEARS ENDED DECEMBER 31, 2024 AND 2023
Arrangements that include rights to additional goods or services that are exercisable at a customer’s discretion are generally considered discretionary purchase options. The Company assesses if these options provide a material right to the customer and if so, they are considered performance obligations.
During 2020, the Company entered into a license agreement, or the Arctic Vision License Agreement, with Arctic Vision (Hong Kong) Limited, or Arctic Vision, and a license agreement, or the Bausch License Agreement, with Bausch Health Companies, Inc., or Bausch + Lomb. Each license has three revenue components:
1) an upfront license fee;
2) milestone payments and
3) royalty payments.
Arctic Vision License Agreement
On August 10, 2020, the Company entered into the Arctic Vision License Agreement pursuant to which Arctic Vision may develop and commercialize MicroPine for the treatment of progressive myopia and MicroLine for the treatment of presbyopia in Greater China (mainland China, Hong Kong, Macau and Taiwan) and South Korea. On September 14, 2021, the Company and Arctic Vision executed Amendment 1 to the Arctic Vision License Agreement pursuant to which Arctic Vision may develop and commercialize MicroStat for the treatment of mydriasis in Greater China and South Korea.
Milestone Payments
The Company may receive up to $ 37.7 million in milestone payments in connection with the Arctic Vision License Agreement, as amended, based on various development and regulatory milestones, including the initiation of clinical research and regulatory approvals in Greater China and South Korea, related to the filing of marketing authorization applications of approximately $ 13.2 million and the receipt of regulatory approvals of approximately $ 24.5 million. It is currently unknown when the remaining milestones related to the performance obligations will be achieved.
Royalty Payments
Arctic Vision also will purchase its supply of MicroPine, MicroLine and MicroStat from the Company or, for such products not supplied by the Company, pay the Company a mid-single digit percentage royalty on net sales of such products, subject to certain adjustments. No royalty payments were earned through December 31, 2024. The Company will pay a percentage in the range from 30 % to 40 % of such payments, royalties, or net proceeds of such supply to Senju pursuant to the Senju License Agreement. See Note 10—Related Party Transactions—Senju License Agreement for additional details.
Bausch License 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 90 days ’ written notice.
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.
F-11
EYENOVIA, INC.
NOTES TO THE FINANCIAL STATEMENTS
FOR THE YEARS ENDED DECEMBER 31, 2024 AND 2023
Pursuant to the Letter Agreement, the Company paid Bausch + Lomb an upfront payment of $ 2.0 million in cash on January 22, 2024. The Company recorded this amount as an operating expense. In connection with the entry into the Letter Agreement, the Company also agreed to issue Bausch + Lomb $ 3.0 million in shares of the Company’s common stock, following the Regulatory Transfer Date (the “Transfer Date”). On April 11, 2024, the Transfer Date, the transfer of the rights and certain assets relating to the CHAPERONE trial from Bausch + Lomb to the Company, was completed. On May 3, 2024, the Company issued Bausch + Lomb 28,742 shares of the Company’s common stock (calculated pursuant to the Letter Agreement at $ 3.0 million using a thirty-day volume-weighted average price on April 11, 2024, but valued at $ 2.3 million on the May 3, 2024 settlement date, resulting in a $ 0.7 million change in fair value of the equity consideration payable), in satisfaction of its obligations pursuant to the Letter Agreement.
Pursuant to the Side Letter (see Note 10 – Commitments and Contingencies - Defective Clinical Supply), the Company agreed to pay approximately $ 0.5 million to Bausch + Lomb related to the defective clinical supply. It was also agreed that the Company will receive approximately $ 0.25 million from Bausch + Lomb to fund the vendor hold back liability that will be due upon completion of the CHAPERONE study. In addition, the Company purchased $ 0.5 million of clinical supplies from Bausch + Lomb in April 2024.
Clinical Supply Arrangements
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 10 % mark-up basis. Based on the Letter Agreement with Bausch + Lomb referenced above, the arrangement with Bausch + Lomb is terminated. The arrangement with Arctic Vision is still in place. The Company’s licensing agreement with 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) report the net income from the clinical supply arrangements as other income. Deferred clinical supply costs were $ 0.0 million and $ 4.3 million at December 31, 2024 and 2023, respectively. Net income from the sale of clinical supplies was included in other income and amounted to $ 0.0 million and $ 0.2 million for the years ended December 31, 2024 and 2023, but a $ 0.4 million provision for possible product returns was also charged against the results for the year ended December 31, 2023. This provision was for the cost to replace or rework the defective clinical supply product. See Note 10 – Commitments and Contingencies – Defective Clinical Supply.
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 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:
December 31,
2024
2023
Finished goods
$
—
$
30,683
Work-in-process
—
—
Raw materials
—
79,115
Total inventory
$
—
$
109,798
During the year ended December 31, 2024, the Company recorded a charge of approximately $ 3.1 million of inventories to cost of revenue in order to write down inventories to their net realizable value.
Intangible Assets
Intangible assets are stated at fair value as of the date acquired, less accumulated amortization. Amortization is calculated based on the estimated useful lives of the assets, using the straight-line method or another method that more fairly represents the utilization of the assets.
The Company periodically evaluates the remaining useful lives of our intangible assets to determine whether events or circumstances warrant a revision to the remaining periods of amortization. In the event that the estimate of an intangible asset’s remaining useful life
F-12
EYENOVIA, INC.
NOTES TO THE FINANCIAL STATEMENTS
FOR THE YEARS ENDED DECEMBER 31, 2024 AND 2023
has changed, the remaining carrying amount of the intangible asset is amortized prospectively over that revised remaining useful life. If it is determined that an intangible asset has an indefinite useful life, that intangible asset would be subject to impairment testing annually or whenever events or circumstances indicate that its carrying value may not, based on future undiscounted cash flows or market factors, be recoverable.
Operating Leases
The Company leases its facilities under non-cancellable operating leases. The Company evaluates the nature of each lease at the inception of an arrangement to determine whether it is an operating or financing lease and recognizes the right-of-use asset and lease liabilities based on the present value of future minimum lease payments over the expected lease term. The Company recognizes a liability to make lease payments, the “lease liability”, and an asset representing the right to use the underlying asset during the lease term, the “right-of-use asset”. The lease liability is measured at the present value of the remaining lease payments, discounted at the Company’s incremental borrowing rate. The Company’s leases do not generally contain an implicit interest rate and therefore the Company uses the incremental borrowing rate it would expect to pay to borrow on a similar collateralized basis over a similar term in order to determine the present value of its lease payments. The right-of-use asset is measured at the amount of the lease liability adjusted for the remaining balance of any lease incentives received, any cumulative prepaid or accrued rent if the lease payments are uneven throughout the lease term, any unamortized initial direct costs, and any impairment of the right-of-use-asset. Operating lease expense consists of a single lease cost calculated so that the remaining cost of the lease is allocated over the remaining lease term on a straight-line basis, variable lease payments not included in the lease liability, and any impairment of the right-of-use asset.
Research and Development
Research and development expenses are charged to operations as incurred. The Company records prepaid expenses on its balance sheet for the payment of research and development expenses in advance of services being provided.
The Company’s license agreements were determined to represent collaborative arrangements. Pursuant to these collaborative arrangements, the licensee is required to reimburse the Company for certain research and development expenses. Providing research and development activities in the context of a collaboration agreement is not an ordinary activity for the Company. Accordingly, the licensee is not a customer with respect to the reimbursements and such payments are not subject to ASC 606 – Revenue Recognition. The Company’s policy is to recognize the reimbursements as contra – research and development expense. The receivable for such payments, plus other license payments, is included in “license fee and expense reimbursements receivable” on the accompanying balance sheets.
Stock-Based Compensation
The Company measures the cost of services received in exchange for an award of equity instruments based on the fair value of the award. The fair value of the award is measured on the grant date and the fair value amount is then recognized over the period during which services are required to be provided in exchange for the award, usually the vesting period. Upon the exercise of an option, the Company issues new shares of common stock out of the shares reserved for issuance under its equity plans. See Note 12 – Stockholders’ Equity – Stock Options for additional information related to estimating the fair value of stock options.
F-13
EYENOVIA, INC.
NOTES TO THE FINANCIAL STATEMENTS
FOR THE YEARS ENDED DECEMBER 31, 2024 AND 2023
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 Years Ended
December 31,
2024
2023
Numerator:
Net loss attributable to common stockholders
$
( 49,818,433 )
$
( 27,261,096 )
Denominator (weighted average quantities):
Common shares issued
830,569
498,848
Add: Prefunded warrants
—
13,025
Add: Undelivered vested restricted shares
2,428
1,038
Denominator for basic and diluted net loss per share
832,997
512,912
Basic and diluted net loss per common share
$
( 59.81 )
$
( 53.15 )
The following securities are excluded from the calculation of weighted average dilutive shares of common stock because their inclusion would have been anti-dilutive:
December 31,
2024
2023
Warrants
1,166,017
136,581
Options
68,183
66,329
Convertible notes
29,096
29,096
Restricted stock units
4,611
1,325
Total potentially dilutive shares
1,267,907
233,331
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 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.
In November 2024, The FASB issued ASU 2024-03, Income Statement – Reporting Comprehensive Income – Expense Disaggregation Disclosures (Subtopic 220 – 04). This update requires an entity to disclose more detailed information regarding expenses for the entity. The amendments require that at each interim and the annual reporting period, the entity must disclose amounts related to purchases of inventory, employee compensation, depreciation, intangible asset amortization and depreciation, depletion, and amortization recognized as part of oil and gas- producing activities. Including the amounts, the entity is required to disclose and qualitative description of the amounts remaining in relevant expense captions, and to disclose the total amount of selling expenses and the definition of selling
F-14
EYENOVIA, INC.
NOTES TO THE FINANCIAL STATEMENTS
FOR THE YEARS ENDED DECEMBER 31, 2024 AND 2023
expenses. The amendments in this update should be applied prospectively to financial statements issued for reporting periods, and retrospectively to any prior periods presented in the financials. Although early adoption is permitted, the new guidance becomes effective for annual reporting periods beginning after December 15, 2026, and interim reporting periods beginning after December 15, 2027. 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.
Recently Adopted Accounting Standards
In November 2023, the FASB issued ASU 2023-07 “Segment Reporting (Topic 280): Improvements to Reportable Segment Disclosures.” These amendments require a public entity to disclose significant segment expenses and other segment items on an annual and interim basis and to provide in interim periods all disclosures about a reportable segment’s profit or loss and assets that are currently required annually. Public entities with a single reporting segment are required to provide both the new disclosures and all of the existing disclosures required under ASC 280. The guidance is effective for fiscal years beginning after December 15, 2023, and interim periods within fiscal years beginning after December 15, 2024, with early adoption permitted. The Company adopted this ASU for the year ended December 31, 2024. Since this new ASU addresses only disclosures, the adoption of this ASU did not have a material effect on the Company’s financial condition, results of operations or cash flows.
Note 3 – Prepaid Expenses and Other Current Assets
As of December 31, 2024 and 2023, prepaid expenses and other current assets consisted of the following:
December 31,
2024
2023
Payroll tax receivable
$
288,705
$
500,684
Prepaid insurance expenses
148,117
167,338
Prepaid general and administrative expenses
61,610
85,938
Prepaid patent expenses
49,967
48,409
Prepaid research and development expenses
26,996
421,056
Prepaid rent and security deposit
18,750
18,750
Other
10,688
—
Prepaid conference expenses
1,108
123,556
Total prepaid expenses and other current assets
$
605,941
$
1,365,731
As of December 31, 2024, the Company wrote off $ 710,820 of prepaid regulatory expenses, due to the uncertainty associated with the Company’s clobetasol propionate and Mydcombi products and its exploration of strategic alternatives.
Note 4 - Property and Equipment, Net
As of December 31, 2024 and 2023, property and equipment consisted of the following:
December 31,
2024
2023
Equipment
$
4,013,211
$
3,038,651
Leasehold improvements
1,788,537
1,754,779
5,801,748
4,793,430
Less: impairment
( 3,254,254 )
—
Less: accumulated depreciation
( 2,547,494 )
( 1,419,046 )
Property and equipment, net
$
—
$
3,374,384
Equipment not yet placed in service
$
—
$
711,441
Depreciation expense was $ 1,128,449 and $ 783,208 for the years ended December 31, 2024 and 2023, respectively, of which $ 1,112,464 and $ 776,479 , respectively, was included within research and development expenses and $ 15,985 and $ 6,729 , respectively, was included in selling, general and administrative expenses in the accompanying statements of operations.
F-15
EYENOVIA, INC.
NOTES TO THE FINANCIAL STATEMENTS
FOR THE YEARS ENDED DECEMBER 31, 2024 AND 2023
As of December 31, 2023, the Company had $ 711,441 of outstanding deposits for equipment purchases, which are presented as non-current assets on the balance sheet. As of December 31, 2024, the Company impaired the $ 711,441 outstanding deposits due to the uncertainty associated with idling its manufacturing operations for Mydcombi.
Additionally, the Company impaired $ 3,254,254 of its remaining fixed assets due to the uncertainty associated with its operations and its exploration of strategic alternatives.
Note 5 – 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, 0.05 % (the “Formosa Licensed Product”), which was approved by the FDA for ophthalmic use for inflammation and pain after ocular surgery and supplemental disease indications, if any, associated with the New Drug Application for the Formosa Licensed Product. 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. The Company paid Formosa the aggregate amount of $ 2.0 million (the “Upfront Payment”), consisting of (a) cash in the amount of $ 1.0 million and (b) 6,097 shares of common stock, which is included in Intangible Assets on the accompanying balance sheet. The Company also capitalized $ 122,945 of transaction costs, which were primarily legal expenses. In addition to the Upfront Payment, the Company must pay Formosa up to $ 4.0 million upon the achievement of certain development milestones and up to $ 80.0 million upon the achievement of certain sales milestones. The trigger for the initial $ 2.0 million development milestone payments 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. This occurred on March 14, 2024. Under the provisions of the Formosa License, the Company had 45 days from the effective date of acceptance of the transfer and assignment of FDA approval to make the payment half in cash and half in common stock, otherwise the payment due would revert to be fully in cash. The Company paid Formosa the aggregate amount of $ 2.0 million, consisting of (a) cash in the amount of $ 1.0 million on April 26, 2024 and (b) 7,668 shares of common stock on April 29, 2024 (calculated pursuant to the Formosa License 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, resulting in a $ 0.6 million change in fair value of the equity consideration payable), which was included in our impairment of Intangible Assets at December 31, 2024. The second $ 2.0 million development milestone (to be fully paid in cash) was earned upon FDA approval of the Formosa Licensed Product and payment was triggered on the earlier of twelve months after FDA approval or six months following the first commercial sale of the Formosa Licensed Product. As of the Form 10-K filing date, this payment remains unpaid and under negotiation. Because the payment became probable and estimable, the Company recorded an additional $ 2.0 million increase in the intangible asset which was included in accrued expenses at December 31, 2024.
It was determined that the transaction represented an asset acquisition, rather than a business combination, because substantially all of the fair value of the assets acquired is concentrated in a single identifiable asset. Consequently, the accounting is pursuant to the cost accumulation model. The Upfront Payment has been capitalized as an intangible asset by the Company.
In October 2024, the Company had its first commercial sale of the Licensed Product, however, due to the uncertainty associated with its clobetasol propionate product, the Company impaired the full $ 6,122,945 carrying value of the Formosa License at December 31, 2024.
Note 6 – Accrued Compensation
As of December 31, 2024 and 2023, accrued compensation consisted of the following:
December 31,
2024
2023
Accrued bonus expenses
$
—
$
1,302,997
Accrued payroll expenses
144,161
355,616
Total accrued compensation
$
144,161
$
1,658,613
F-16
EYENOVIA, INC.
NOTES TO THE FINANCIAL STATEMENTS
FOR THE YEARS ENDED DECEMBER 31, 2024 AND 2023
Note 7 – Accrued Expenses and Other Current Liabilities
As of December 31, 2024 and 2023, accrued expenses and other current liabilities consisted of the following:
December 31,
2024
2023
Accrued intangible milestone obligation
$
2,000,000
$
—
Other
302,880
7,835
Accrued licensee reimbursement
295,711
—
Accrued rework of clinical supply returns
250,000
100,000
Accrued fixed asset disposal costs
125,000
—
Accrued professional services
111,750
63,028
Accrued clinical studies costs
85,409
—
Credit card payable
7,763
27,193
Accrued research and development expenses
—
89,872
Total accrued expenses and other current liabilities
$
3,178,513
$
287,928
Note 8 – Notes Payable and Convertible Notes Payable
As of December 31, 2024 and 2023, notes payable and convertible notes payable consisted of the following:
December 31, 2024
December 31, 2023
Notes Payable
Debt Discount
Net
Notes Payable
Debt Discount
Net
Current portion:
Avenue - Note payable
$
5,740,402
$
( 527,870 )
$
5,212,532
$
5,833,333
$
( 503,914 )
$
5,329,419
Avenue - Convertible note payable
5,000,000
( 263,930 )
4,736,070
—
—
—
Total current portion
$
10,740,402
$
( 791,800 )
$
9,948,602
$
5,833,333
$
( 503,914 )
$
5,329,419
Non-Current portion:
Avenue - Note payable
$
—
$
—
$
—
$
4,804,167
$
( 448,367 )
$
4,355,800
Avenue - Convertible note payable
—
—
—
5,000,000
( 398,569 )
4,601,431
Total non-current portion
$
—
$
—
$
—
$
9,804,167
$
( 846,936 )
$
8,957,231
BankDirect Capital Finance Loan
On February 24, 2023, the Company issued a note payable in the amount of $ 609,140 for the purchase of a directors and officers’ liability insurance policy (the “2023 D&O Loan”). The note accrued interest at a rate of 7.11 % per year and matured on August 24, 2023 . The 2023 D&O Loan was payable in six monthly payments of $ 103,639 consisting of principal and interest. The note payable was repaid in full during the year ended December 31, 2023. Interest expense was $ 12,694 for the year ended December 31, 2023.
On February 24, 2024, the Company issued a note payable in the amount of $ 505,050 for the purchase of a directors and officers’ liability insurance policy (the “2024 D&O Loan”). The note accrued interest at a rate of 8.15 % per year and matured on October 24, 2024 . The 2024 D&O Loan was payable in eight monthly payments of $ 65,076 consisting of principal and interest. The note payable was repaid in full during the year ended December 31, 2024. Interest expense was $ 15,558 for the year ended December 31, 2024.
Avenue Ventures Loan
On November 22, 2022, the Company entered into a Loan and Security Agreement (the “Avenue Loan Agreement”) with Avenue Venture Opportunities Fund, L.P., (“Avenue 1”), and Avenue Venture Opportunities Fund, L.P. II, (“Avenue 2”), and together with Avenue, (the “Lender”), for an aggregate principal amount of up to $ 15,000,000 (the “Avenue Loan”). The initial tranche of the Avenue Loan was $ 10,000,000 , consisting of $ 4,000,000 from Avenue and $ 6,000,000 from Avenue 2. Up to $ 5,000,000 of the principal amount outstanding may be converted at the option of the Lender into shares of the Company’s common stock at a conversion price of $ 171.84
F-17
EYENOVIA, INC.
NOTES TO THE FINANCIAL STATEMENTS
FOR THE YEARS ENDED DECEMBER 31, 2024 AND 2023
per share, subject to typical anti-dilution adjustments. The Avenue Loan bears interest at an annual rate equal to the greater of (a) 7.0 % and (b) the prime rate as reported in The Wall Street Journal plus 4.45 %. The Avenue Loan maturity date is November 1, 2025. The Company was able to request an additional $ 5,000,000 of gross funding between April 1, 2023 and July 31, 2023, subject to agreed-upon conditions. The Company must also make an incremental final payment equal to 4.25 % of the aggregate funding, amounting to a premium of $ 425,000 on the initial tranche. The Company will make monthly interest-only payments during the first twelve months of the Avenue Loan, which could be increased to up to eighteen months upon the achievement of specified performance milestones. Following the interest-only period, the Company will make equal monthly payments of principal and interest until the maturity date, plus interest. If the Company prepays the Avenue Loan, it will be required to pay a prepayment fee of 3 % if the Avenue Loan is prepaid during the first year, 2 % if the Avenue Loan is prepaid during the second year and 1 % if the Avenue Loan is repaid during the third year.
On May 22, 2023, pursuant to the Loan and Security Agreement, the Company received an additional tranche of non-convertible debt funding in the amount of $ 5,000,000 . The Company paid approximately $ 126,000 of origination and legal fees connected to this debt funding. The additional funding is subject to the same interest and maturity date as the initial tranche. The additional funding triggered the extension of the interest-only payment period from the original 12 months to 18 months (through May 2024) for the entire outstanding balance due under the Avenue Loan Agreement (initial and additional tranches). Following the interest-only period, the Company will make equal monthly payments of principal until the maturity date, plus interest. The Company must also make a final payment equal to 4.25 % of the additional tranche, amounting to a premium of $ 212,500 on the additional tranche. The total final payment on the aggregate borrowing is $ 637,500 . If the Company prepays the Avenue Loan, it will be required to pay a prepayment fee of 2 % if the Avenue Loan is prepaid during the second year and 1 % if the Avenue Loan is repaid during the third year.
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 $ 833,333 per month plus interest.
On November 22, 2024, the Company entered into an amendment of the Avenue Loan (the “First Amendment”), whereby the Lender agreed to defer principal and interest payments on the amounts outstanding until March 2025. In connection with the First Amendment, the Company granted an aggregate of 23,771 shares of its common stock to the Lender. The price per share was based on the Company’s five trading-day volume-weighted average price (VWAP) preceding the date of the First Amendment of approximately $ 8.42 per share. The shares have a gross value of approximately $ 200,000 . This is accounted for as a component of debt discount.
The Avenue Loan requires the Company to make and maintain representations and warranties and other agreements that are customary in loan agreements of this type. The Avenue Loan is secured by all of the Company’s assets, including intellectual property. The Avenue Loan also contains customary events of default, including non-payment of principal or interest, violations of covenants, bankruptcy and material judgments. Upon the occurrence of an event of default, all interest and principal immediately become due and payable. In addition, Avenue will have the right to exercise any other right or remedy provided by applicable law.
The following is a summary of the Avenue loan at December 31, 2024:
December 31, 2024
Non-Convertible
Convertible
Total
Aggregate Loan Funding
$
10,000,000
$
5,000,000
$
15,000,000
Capitalized Interest Added To Loan Balance
102,902
—
102,902
Final Payment
637,500
—
637,500
10,740,402
5,000,000
15,740,402
Less: Payments
( 5,000,000 )
—
( 5,000,000 )
Less: Unamortized Debt Discount
( 527,870 )
( 263,930 )
( 791,800 )
5,212,532
4,736,070
9,948,602
Less: Current Portion
( 5,212,532 )
( 4,736,070 )
( 9,948,602 )
Notes Payable, Non-Current
$
—
$
—
$
—
During the years ended December 31, 2024 and 2023, the Company recorded interest expense relating to the Avenue Loan of $ 2,468,863 (which includes $ 759,049 of amortization of debt discount) and $ 2,359,157 (which includes $ 681,860 of amortization of debt discount), respectively.
F-18
EYENOVIA, INC.
NOTES TO THE FINANCIAL STATEMENTS
FOR THE YEARS ENDED DECEMBER 31, 2024 AND 2023
See Note 15 – Subsequent Events - Avenue Ventures Loan Second Amendment.
Note 9 – Income Taxes
The provision for income taxes consists of the following (expenses) benefits:
For The Years Ended
December 31,
2024
2023
Deferred tax (provision) benefit:
Federal
$
12,749,587
$
5,381,793
State and local
9,773,203
( 849,201 )
22,522,790
4,532,592
Change in valuation allowance
( 22,522,790 )
( 4,532,592 )
Provision for income taxes
$
—
$
—
The provision for income taxes differs from the United States Federal statutory rate as follows:
For The Years Ended
December 31,
2024
2023
Federal statutory rate
( 21.0 )
%
( 21.0 )
%
State tax rate, net of federal benefit
( 13.2 )
%
0.0
%
Permanent differences
1.0
%
1.2
%
Research & development tax credits
( 0.8 )
%
0.0
%
Prior period adjustments and other
( 3.6 )
%
1.3
%
Rate and apportionment changes
( 7.6 )
%
1.9
%
Change in valuation allowance
45.2
%
16.6
%
Effective income tax rate
0.0
%
0.0
%
F-19
EYENOVIA, INC.
NOTES TO THE FINANCIAL STATEMENTS
FOR THE YEARS ENDED DECEMBER 31, 2024 AND 2023
Deferred tax assets consist of the following:
For The Years Ended
December 31,
2024
2023
Deferred tax assets:
Net operating loss carryforwards
$
35,921,285
$
23,804,461
Research and development tax credits
1,995,653
528,894
Capitalized research and development costs
8,177,548
3,581,962
Stock-based compensation
3,026,311
2,080,864
Intangible assets
3,322,919
688,745
Lease liability
441,895
376,883
Property and equipment
246,074
—
Total gross deferred tax assets
53,131,685
31,061,809
Valuation allowance
( 52,886,116 )
( 30,363,326 )
Deferred tax assets, net of valuation allowance
245,569
698,483
Deferred tax liabilities
Property and equipment
—
( 348,323 )
Right of use asset
( 245,569 )
( 350,160 )
Deferred tax liabilities, net
$
—
$
—
Changes in valuation allowance
$
( 22,522,790 )
$
( 4,532,592 )
As of December 31, 2024, the Company had approximately $ 133,700,000 of domestic federal net operating loss carryforwards, or NOLs, that may be available to offset future federal taxable income. Approximately $ 10,800,000 of those NOLs will expire during the years ranging from 2034 to 2037 . The remaining NOLs of approximately $ 122,900,000 have no expiration dates. Internal Revenue Code Section 382 limits the utilization of approximately $ 35,000,000 of those NOLs to approximately $ 918,000 on an annual basis as a result of ownership changes that occurred through July 15, 2019. As of December 31, 2024, the Company had approximately $ 66,400,000 of state NOLs, of which approximately $ 66,200,000 will expire during the years ranging from 2040 to 2044 , and approximately $ 200,000 will not expire, and had approximately $ 52,200,000 of local NOLs which do not expire.
The Company has assessed the likelihood that deferred tax assets will be realized in accordance with the provisions of ASC 740 “Income Taxes Accounting”, or ASC 740. ASC 740 requires that a valuation allowance be established when it is “more likely than not” that all, or a portion of, deferred tax assets will not be realized. The assessment considers all available positive or negative evidence, including the scheduled reversal of deferred tax liabilities, projected future taxable income, and tax planning strategies. After the performance of such reviews as of December 31, 2024 and 2023, management believes that uncertainty exists with respect to future realization of its deferred tax assets and has, therefore, established a full valuation allowance as of those dates.
Management has evaluated and concluded that there were no material uncertain tax positions requiring recognition in the Company’s financial statements as of December 31, 2024 and 2023. The Company does not expect any significant changes in its unrecognized tax benefits within twelve months of the reporting date.
No tax audits were commenced or were in process during the years ended December 31, 2024 and 2023. No tax related interest or penalties were incurred during the years ended December 31, 2024 and 2023. The Company’s federal, state and local income tax returns beginning with the year ended December 31, 2021 remain subject to examination.
F-20
EYENOVIA, INC.
NOTES TO THE FINANCIAL STATEMENTS
FOR THE YEARS ENDED DECEMBER 31, 2024 AND 2023
Note 10 – Commitments and Contingencies
Employment Agreements
As of December 31, 2024, the aggregate potential severance pay for the executive officers of the Company is approximately $ 1,029,000 .
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 $ 0.4 million to Bausch + Lomb related to the defective clinical supply which charge was included within other income (expense) during the year ended December 31, 2023, because the original sales to the licensee were recorded on that line item. See Note 2 – Summary of Significant Accounting Policies - Bausch License Agreements.
Operating Leases
In April 2022, the Company entered into a new lease agreement for 3,916 square feet in Laguna Hills, California. The new lease term is five years and two months , commencing on June 1, 2022 and expiring on July 31, 2027 . The monthly base rent ranges from $ 9,203 to $ 10,358 per month over the term of the lease. The security deposit is $ 11,400 . The Company’s rent expense for all Laguna Hills space is recorded in selling, general and administrative expense and amounted to $ 117,890 and $ 118,746 for the years ended December 31, 2024 and 2023, respectively. As of December 31, 2024, the Company recorded an impairment of the right-of-use asset of $ 116,000 associated with this lease in the Company’s financial statements due to the uncertainty associated with its operations and its exploration of strategic alternatives.
In May 2022, the Company entered into a lease agreement to lease 10,880 square feet of office space in Reno, Nevada. The lease term is five years and four months , commencing on May 23, 2022 and expiring on September 23, 2027 . The monthly base rent ranges from $ 13,056 to $ 16,663 per month over the term of the lease. The security deposit is $ 53,000 . The Company’s rent expense for this space is recorded in research and development expense and amounted to $ 169,303 and $ 164,950 for the years ended December 31, 2024 and 2023, respectively. As of December 31, 2024, the Company recorded an impairment of the right-of-use asset of $ 80,000 associated with this lease in the Company’s financial statements due to the uncertainty associated with its operations and its exploration of strategic alternatives.
In February 2023, the Company exercised its options to renew its three leases in Redwood City, California, for a total of approximately 6,700 square feet. The leases were due to expire on August 31, 2023 . The leases were extended from September 1, 2023 to August 31, 2025. The aggregate monthly base rent ranges from $ 15,742 to $ 16,700 per month over the term of the lease. The security deposit is $ 14,968 . The Company’s rent expense for this space is recorded in research and development expense and amounted to $ 193,591 and $ 192,710 for the years ended December 31, 2024 and 2023, respectively. As of December 31, 2024, the Company recorded an impairment of the right-of-use asset of $ 125,000 associated with this lease in the Company’s financial statements due to the uncertainty associated with its operations and its exploration of strategic alternatives.
In June 2023, the Company entered into an extension agreement to renew its lease for approximately 3,800 square feet of office space in New York, NY. The lease was due to expire on September 30, 2023 . The lease was extended from November 1, 2023 to December 31, 2026. The monthly base rent ranges from $ 19,633 to $ 21,298 per month over the term of the lease. The security deposit is $ 117,800 . The Company’s rent expense for this space is recorded in selling, general and administrative expense and amounted to $ 220,394 and $ 233,534 for the years ended December 31, 2024 and 2023, respectively. As of December 31, 2024, the Company recorded an impairment of the right-of-use asset of $ 99,000 associated with this lease in the Company’s financial statements due to the uncertainty associated with its operations and its exploration of strategic alternatives.
F-21
EYENOVIA, INC.
NOTES TO THE FINANCIAL STATEMENTS
FOR THE YEARS ENDED DECEMBER 31, 2024 AND 2023
A summary of the Company’s right-of-use assets and liabilities is as follows:
For the Years Ended
December 31,
2024
2023
Cash paid for amounts included in the measurement of lease liabilities:
Operating cash flows used in operating activities
$
501,250
$
503,046
Right-of-use assets obtained in exchange for lease obligations
Operating leases
$
—
$
904,437
Weighted Average Remaining Lease Term (Years)
Operating leases
2.16
3.04
Weighted Average Discount Rate
Operating leases
10.0
%
10.0
%
Future minimum payments under the Company’s operating lease agreements are as follows:
For the Years Ending
December 31,
Minimum Lease Payments
2025
$
675,400
2026
560,996
2027
214,618
Total future minimum lease payments
1,451,014
Less: Imputed interest
( 158,347 )
Present value of lease liabilities
1,292,667
Less: current portion
( 575,163 )
Lease liabilities, non-current portion
$
717,504
Litigations, Claims and Assessments
In the normal course of business, the Company may be involved in legal proceedings, claims and assessments arising in the ordinary course of business. The Company records legal costs associated with loss contingencies as incurred and accrues for all probable and estimable settlements.
Senju License Agreement
See Note 11 – Related Party Transactions - Senju License Agreement for a related party agreement entered into with Senju.
Note 11 – Related Party Transactions
Senju License Agreement
During 2015, the Company entered into an exclusive license agreement with Senju, or the Senju License Agreement, whereby the Company agreed to grant to Senju an exclusive, royalty-bearing license for its microdose product candidates for Asia to sublicense, develop, make, have made, manufacture, use, import, market, sell, and otherwise distribute the microdose product candidates. In consideration for the license, Senju agreed to pay to Eyenovia five percent ( 5 %) royalties on sales (net of certain manufacturing costs) for the term of the Senju License Agreement, subject to certain adjustments upon the loss of patent coverage for the term of the license agreement. The agreement will continue in full force and effect, on a country-by-country basis, until the latest to occur of: (i) the tenth (10th) anniversary of the first commercial sale of such a product candidate in a country; or (ii) the expiration of the licensed patents in a country. As of the date of this filing, there have been no commercial sales of such a product in Asia; therefore, no royalties have been earned. Senju is owned by the family of a former member of the Company’s Board of Directors.
F-22
EYENOVIA, INC.
NOTES TO THE FINANCIAL STATEMENTS
FOR THE YEARS ENDED DECEMBER 31, 2024 AND 2023
On April 8, 2020, Eyenovia entered into an amendment, (the “Senju License Amendment”), to the Senju License Agreement. Pursuant to the Senju License Amendment, the Company can license to any third party the right to research, develop, commercialize, manufacture or use certain products, or the Senju Licensed Products previously licensed to Senju in China (including the People’s Republic of China, Hong Kong, Macao, and Taiwan) and South Korea, or the Territory.
Pursuant to the Senju License Amendment, the Company must pay Senju (a) a percentage in the range of 30 % to 40 % of revenue on (i) any lump-sum payments the Company receives from the third party, (ii) revenue (net of costs) obtained by the Company from contract research and/or development of the Senju Licensed Product in the Territory, and (iii) revenue (net of costs) obtained by the Company from contract manufacture for the device of the Senju Licensed Product in the Territory, the aggregate of which must be at least a $ 9 million minimum payment to Senju; and (b) a percentage in the range of 30 % to 40 % of any sales royalty revenue the Company receives from the third party. Since the Company executed a third-party license prior to the April 8, 2021 expiration of the Senju License, the Senju License Amendment will remain in effect for the duration of the license, subject to early termination.
The Senju License Agreement was further amended in a Letter Agreement by and between the Company and Senju on August 10, 2020, or the Letter Agreement. Pursuant to the Letter Agreement, the Company will pay to Senju a percentage in the range of 30 % to 40 % of certain payments, royalties, or net proceeds received from Arctic Vision in connection with the Arctic Vision License Agreement. The Senju License Agreement was amended further by the License Amendment 2, effective September 14, 2021, (“Amendment 2”). The Amendment 2 excludes Greater China and South Korea from the territory in which Senju was granted an exclusive royalty-bearing license from the Company. In consideration for this exclusion, and upon and after the execution of Amendment 1 with Arctic Vision, the Company must make payments to Senju based on non-royalty license revenue and sales revenue, including the following:
1. a one-time upfront payment of $ 250,000 , paid on September 17, 2021, which represented an inducement to Senju to approve Amendment 1 of the Arctic Vision License Agreement related to the MicroStat product.
2. a percentage in the range from 30 % to 40 % of any upfront or milestone lump sum payments, or net revenues received by the Company in connection with any licensed product using piezo-print technology in a microdose dispenser containing: (a) the chemical substance atropine sulfate as its sole active ingredient and that is used for the treatment of myopia in humans; (b) the chemical substance pilocarpine as its sole active ingredient and that is used for the treatment of presbyopia in humans; or (c) the chemical substances phenylephrine and tropicamide in combination as active ingredients that are used for pharmaceutical mydriasis in humans (the “LA2 Licensed Product”) from certain third parties, and
3. a percentage in the range from thirty to forty percent of the amounts received by the Company in connection with sales of the LA2 Licensed Product in China and South Korea by certain third parties.
Advisory Agreement
In August 2022, the Company entered into an agreement with Dr. Ianchulev, or the Executive Chairman Agreement, pursuant to which Dr. Ianchulev agreed to 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 . The terms allowed for the agreement to be extended by mutual agreement of the parties. In consideration for Dr. Ianchulev’s services, the Company 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. As of December 31, 2024, the agreement was still in effect.
F-23
EYENOVIA, INC.
NOTES TO THE FINANCIAL STATEMENTS
FOR THE YEARS ENDED DECEMBER 31, 2024 AND 2023
Note 12 – Stockholders’ (Deficiency) Equity
Authorized Capital
The Company is authorized to issue 300,000,000 shares of common stock, par value of $ 0.0001 per share, and 6,000,000 shares of preferred stock, par value of $ 0.0001 per share. The holders of the Company’s common stock are entitled to one vote per share. The Board of Directors is empowered, without stockholder approval, to issue preferred stock with dividend, liquidation, redemption, voting or other rights. 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 90,000,000 to 300,000,000 at the same par value of $ 0.0001 per share.
Equity Incentive Plans
On April 7, 2020, the Company’s Board of Directors approved the Company’s Amended and Restated 2018 Omnibus Stock Incentive Plan (the “Restated Plan”), which stockholders approved on June 30, 2020. Under the Restated Plan, as amended on June 16, 2022 and June 27, 2023, 83,750 shares of the Company’s common stock are reserved for issuance. The Restated Plan requires that all equity awards issued under the Restated Plan vest at least twelve months from the applicable grant date, subject to accelerated vesting, and provides that no dividend or dividend equivalent will be paid on any unvested equity award, although dividends with respect to unvested portions of equity may accrue and be paid when, and if, the awards later vest and the shares are actually issued to the grantee. In addition, the Restated Plan sets an annual limit on the grant date fair value of awards to any non-employee director, together with any cash fees paid during the year, of $ 150,000 , subject to certain exceptions for a non-executive chair of the Board. As of December 31, 2024, the number of securities remaining available for future issuance under equity compensation plans was 14,227 . On January 21, 2025, the stockholders approved an amendment to the Company’s Amended and Restated 2018 Omnibus Stock Incentive Plan to reserve an additional 350,000 shares of the Company’s common stock for issuance (see Note 15 – Subsequent Events, Increase of 2018 Omnibus Stock Incentive Plan Shares).
Common Stock Issuances
Pursuant to the License and certain milestone achievements, the Company issued 7,668 shares of common stock valued at $ 0.4 million on April 29, 2024 to Formosa (see Note 5 – Intangible Assets).
On May 3, 2024, the Company issued Bausch + Lomb 28,742 shares of the Company’s common stock, valued at $ 2.3 million, in satisfaction of its obligations pursuant to the Letter Agreement (see Note 2 – Summary of Significant Accounting Policies - Bausch License Agreements).
At-The-Market Program
December 2021 Sales Agreement
On December 14, 2021, the Company entered into a Sales Agreement, (the “December 2021 Sales Agreement”), with SVB Securities under which the Company may offer and sell, from time to time at its sole discretion, shares of common stock for gross proceeds of up to $ 50.0 million through SVB Securities as its sales agent, or the 2021 Offering. The issuance and sale of shares, if any, of common stock by the Company under the December 2021 Sales Agreement will be pursuant to the Company’s Registration Statement on Form S-3 (File No. 333-261638) filed with the SEC on December 14, 2021, or the Registration Statement, and the prospectus relating to the 2021 Offering filed therewith that forms a part of the Registration Statement.
Subject to the terms and conditions of the December 2021 Sales Agreement, SVB Securities may sell the common stock by any method permitted by law deemed to be an “at the market offering” as defined in Rule 415(a)(4) of the Securities Act of 1933, as amended. SVB Securities will use commercially reasonable efforts to sell the common stock from time to time, based upon instructions from the Company (including any price, time or size limits or other customary parameters or conditions the Company may impose). The Company will pay SVB Securities a commission equal to three percent ( 3.0 )% of the gross sales proceeds of any common stock sold through SVB Securities under the December 2021 Sales Agreement, and also has provided SVB Securities with certain indemnification rights.
F-24
EYENOVIA, INC.
NOTES TO THE FINANCIAL STATEMENTS
FOR THE YEARS ENDED DECEMBER 31, 2024 AND 2023
During the year ended December 31, 2023, the Company received approximately $ 4.7 million in gross proceeds and $ 4.6 million in net proceeds from the sale of 23,327 shares of its common stock under the December 2021 Sales Agreement with Leerink Partners, LLC, formerly known as SVB Securities (“Leerink Partners”).
During the year ended December 31, 2024, the Company received approximately $ 6.2 million in gross proceeds and $ 6.0 million in net proceeds from the sale of 70,382 shares of its common stock under the December 2021 Sales Agreement with Leerink Partners.
On December 30, 2024, the Company entered into an Amended and Restated Sales Agreement (the “A&R Sales Agreement”) with Chardan Capital Markets, LLC (“Chardan”) with respect to the Company’s existing at-the-market offering program. The A&R Sales Agreement amends and restates the December 2021 Sales Agreement by and between the Company and Leerink Partners to, among other things, replace Leerink Partners with Chardan as sales agent. The Company will pay Chardan a commission equal to three percent (3.0)% of the gross sales proceeds of any common stock sold through Chardan under the December 2021 Sales Agreement, and also has provided Chardan with certain indemnification rights.
At December 31, 2024, no shares had settled under the A&R Sales Agreement with Chardan.
Offerings
August 2023 Offering and Warrant Modification
On August 24, 2023, the Company entered into a securities purchase agreement with a certain institutional and accredited investor (the “Purchaser”), pursuant to which the Company agreed to sell, in a registered direct offering by the Company directly to the Purchaser (the “August 2023 Offering”), 52,483 shares of common stock, pre-funded warrants to purchase up to 28,162 shares of common stock and warrants to purchase up to 60,484 shares of common stock (the “Common Warrants” and, together with the Pre-Funded Warrants, the “Warrants”). The combined offering price for each share of common stock and accompanying Common Warrant was $ 148.80 , and the combined offering price for each Pre-Funded Warrant and accompanying Common Warrant was $ 148.00 .
The Common Warrants will be exercisable beginning six months following the date of issuance and may be exercised for a period of five years from the initial exercisability date at an exercise price of $ 178.40 per share. The Pre-Funded Warrants were immediately exercisable and may be exercised at any time until all of the Pre-Funded Warrants are exercised in full at an exercise price of $ 0.80 per share. The exercise prices and numbers of shares of common stock issuable upon exercise of the Common Warrants and the Pre-Funded Warrants are subject to typical anti-dilution provisions. A holder may not exercise any portion of such holder’s Common Warrants or Pre-Funded Warrants to the extent that the holder would own more than 4.99 % of the Company’s outstanding common stock immediately after exercise (unless the holder otherwise elects a limitation of 9.99 %). The Company determined that the Warrants met the criteria to be classified as equity.
The net cash proceeds of the August 2023 Offering were approximately $ 10.9 million after deducting cash issuance costs in the aggregate amount of approximately $ 1.1 million. The August 2023 Offering closed on August 29, 2023.
In connection with the August 2023 Offering, the Company entered into a warrant amendment agreement (the “Amendment”) with the Purchaser, whereby the Company agreed to amend the March 2022 Investor Warrants to (i) reduce the exercise price from $ 283.20 per share of common stock to $ 178.40 per share of common stock, (ii) extend the term of the March 2022 Investor Warrants until March 1, 2029, (iii) include a stockholder approval requirement in connection with a modification of the beneficial ownership limitation and (iv) prohibit exercise of the March 2022 Investor Warrants for the six-month period following the effective date of the Amendment.
The Company accounted for the modification of the March 2022 Investor Warrants as an exchange of the old warrants for new warrants. The incremental value of the new warrant (resulting from the decrease in exercise price from $ 283.20 to $ 178.40 per share and the extension of the warrant expiration date to March 1, 2029) was measured as the excess of the fair value of the modified warrants over the fair value of the original warrants immediately before modification. The increase in the incremental value of $ 1,738,700 was credited to additional paid-in-capital (“APIC”) and debited to APIC as an issuance cost of the August 2023 Offering.
F-25
EYENOVIA, INC.
NOTES TO THE FINANCIAL STATEMENTS
FOR THE YEARS ENDED DECEMBER 31, 2024 AND 2023
2024 Offerings and Warrant Modification
A summary of the 2024 offerings is presented below:
Additional
Total
Common Stock
Paid-In
Stockholders’
Shares
Amount
Capital
Equity
April Offering
40,297
$
4
$
1,888,825
$
1,888,829
July Offering
94,697
10
4,299,391
4,299,401
August Offering
160,624
16
4,451,091
4,451,107
September Offering
107,875
11
3,597,659
3,597,670
November Offering
112,500
11
1,058,792
1,058,803
December Offering
137,500
14
1,715,498
1,715,512
653,493
$
66
$
17,011,256
$
17,011,322
April 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 2024 Offering”), 40,297 shares of common stock. The price per share in the April 2024 Offering was $ 49.63 . The aggregate gross proceeds to the Company from the 2024 April Offering were $ 2.0 million, and net proceeds after offering costs were approximately $ 1.9 million.
July Offering and Warrant Amendment
On July 1, 2024, the Company closed on a registered direct offering (the “July 2024 Offering”) with certain institutional and accredited investors (the “July 2024 Investors”), pursuant to which the Company sold 94,697 shares of common stock and warrants to purchase up to 94,697 shares of common stock. The combined offering price for each share of common stock and accompanying warrant was $ 52.80 . The Company also agreed to issue warrants to purchase an additional 21,872 shares of common stock (the “Additional Warrants”) to one of the July 2024 Investors. All of the new warrants become exercisable six months following their issuance, at an exercise price of $ 55.20 per share, and may be exercised until January 2, 2030.
In connection with the July 2024 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 129,828 shares of common stock, whereby the Company agreed to amend the Prior Warrants to reduce the exercise price of the Prior Warrants from $ 178.40 and $ 197.60 per share of common stock to $ 55.20 per share of common stock, extend the term of the Prior Warrants until January 2, 2030 and prohibit exercise of the Prior Warrants for the six-month period following the effective date of the Amendments.
The aggregate gross proceeds to the Company from the July 2024 Offering were approximately $ 5.0 million, and net proceeds after cash offering costs were approximately $ 4.3 million. Offering costs include placement agent fees of $ 0.4 million and Company legal fees of $ 0.3 million. In addition, there were $ 2.9 million of non-cash issuance costs which represents the value of the Additional Warrants, plus the modification date incremental value of the modified Prior Warrants as compared to the original Prior Warrants, as an issuance cost of the warrant exercise.
August Offering
On August 21, 2024, the Company agreed to sell 160,624 shares of common stock to certain institutional and accredited investors (the “August Investors”), in some cases pursuant to a securities purchase agreement (the “August 2024 Offering”). The price per share in the August 2024 Offering was $ 32.00 . The aggregate gross proceeds to the Company from the August 2024 Offering were approximately $ 5.1 million, and net proceeds after offering costs were approximately $ 4.5 million.
September Offering and Warrant Amendment
On September 30, 2024, the Company closed on a registered direct offering (the “September 2024 Offering”) with a certain purchaser, pursuant to which the Company sold to the purchaser 107,875 shares of common stock; pre-funded warrants to purchase up to 821
F-26
EYENOVIA, INC.
NOTES TO THE FINANCIAL STATEMENTS
FOR THE YEARS ENDED DECEMBER 31, 2024 AND 2023
shares of common stock; and warrants to purchase up to 108,696 shares of common stock at an exercise price of $ 40.00 per share. The combined offering price for each share and accompanying warrant was $ 36.80 . The combined offering price for each pre-funded warrant and accompanying Warrant was $ 36.79 , which is equal to the purchase price per share in the September 2024 Offering, minus $ 0.008 , the exercise price per share of the pre-funded warrants. The warrants will be exercisable beginning six months following the date of issuance and may be exercised until March 31, 2030. The aggregate gross proceeds to the Company from the September 2024 Offering were approximately $ 4.0 million, and net proceeds after offering costs were approximately $ 3.6 million. On October 1, 2024, the holder of the 821 pre-funded warrants issued in the September Offering, exercised the pre-funded warrants at a price of $ 0.008 per share of common stock.
In connection with the December Offering, the Company entered into an amendment of the September Offering warrants to require stockholder approval to be exercisable and the termination date to be five years after stockholder approval.
Subsequently, on January 21, 2025, the stockholders voted to approve the exercise of the September Offering warrants (see Note 15 – Subsequent Events - Stockholder Approval of Warrants).
November Offering and Warrant Amendment
On November 24, 2024, the Company closed on a registered direct offering (the “November 2024 Offering”) with an institutional investor, pursuant to which the Company sold to the purchaser 112,500 shares of common stock; pre-funded warrants to purchase up to 38,522 shares of common stock; and warrants to purchase up to 302,045 shares of common stock at an exercise price of $ 8.608 per share. The combined offering price for each share and accompanying warrant was $ 8.608 The combined offering price for each pre-funded warrant and accompanying Warrant was $ 8.60 , which is equal to the purchase price per share in the November 2024 Offering, minus $ 0.008 , the exercise price per share of the pre-funded warrants. The warrants will be exercisable beginning six months following the date of issuance and may be exercised until November 24, 2029. The aggregate gross proceeds to the Company from the November 2024 Offering were approximately $ 1.3 million, and net proceeds after offering costs were approximately $ 1.1 million. On November 25, 2024, the holder of the 38,522 pre-funded warrants issued in the November Offering, exercised the pre-funded warrants at a price of $ 0.008 per share of common stock.
In connection with the December Offering, the Company entered into an amendment of the November Offering warrants to require stockholder approval to be exercisable and the termination date to be five years after stockholder approval.
Subsequently, on January 21, 2025, the stockholders voted to approve the exercise of the November Offering warrants (see Note 15 – Subsequent Events - Stockholder Approval of Warrants).
December Offering
On December 5, 2024, the Company closed on a registered direct offering (the “December 2024 Offering”) with an institutional investor, pursuant to which the Company sold to the purchaser 137,500 shares of common stock; pre-funded warrants to purchase up to 113,563 shares of common stock; and warrants to purchase up to 502,126 shares of common stock at an exercise price of $ 7.752 per share. The combined offering price for each share and accompanying warrant was $ 7.752 . The combined offering price for each pre-funded warrant and accompanying Warrant was $ 7.744 , which is equal to the purchase price per share in the December 2024 Offering, minus $ 0.008 , the exercise price per share of the pre-funded warrants. The warrants required stockholder approval to be exercisable and the termination date to be five years after stockholder approval. The aggregate gross proceeds to the Company from the December 2024 Offering were approximately $ 1.9 million, and net proceeds after offering costs were approximately $ 1.7 million. On December 11, 2024, the holder of the 113,563 pre-funded warrants issued in the December Offering, exercised the pre-funded warrants at a price of $ 0.008 per share of common stock.
Subsequently, on January 21, 2025, the stockholders voted to approve the exercise of the December Offering warrants (see Note 15 – Subsequent Events - Stockholder Approval of Warrants).
F-27
EYENOVIA, INC.
NOTES TO THE FINANCIAL STATEMENTS
FOR THE YEARS ENDED DECEMBER 31, 2024 AND 2023
Warrants
The issuance date or modification date fair value of stock warrants issued or modified during the years ended December 31, 2024 and 2023 was determined using the Black Scholes method, with the following assumptions used:
For the Years Ended
December 31,
2024
2023
Risk free interest rate
4.39 % - 5.22 %
4.48 %
Expected term
0.7 - 5.5 years
4.0 - 5.5 years
Expected volatility
86 % - 118 %
81 %
Expected dividends
n/a
n/a
A summary of the warrant activity during the year ended December 31, 2024 is presented below:
Weighted
Weighted
Average
Average
Remaining
Number of
Exercise
Life
Warrants
Price
In Years
Outstanding January 1, 2024
136,582
$
182.40
—
Granted (1)
1,029,435
17.22
—
Repriced - (Old) (2)
( 129,828 )
179.65
—
Repriced - (New) (2)
129,828
55.20
—
Exercised (1)
—
—
—
Outstanding December 31, 2024
1,166,017
$
22.33
5.0
Exercisable December 31, 2024
6,754
$
236.88
1.2
(1) Warrants granted and exercised exclude 152,916 Pre-Funded Warrants with an exercise price of $ 0.0001 .
(2) Repriced warrants represent the reset of the exercise price of certain warrants to purchase 129,828 shares of common stock to a price of $ 55.20 per share.
The following table presents information related to warrants as of December 31, 2024:
Warrants Outstanding
Warants Exercisable
Weighted
Outstanding
Average
Exercisable
Exercise
Number of
Remaining Life
Number of
Price
Warrants
In Years
Warrants
$ 7.7520
502,126
(1)
—
—
$ 8.6080
302,045
(1)
—
—
$ 40.0000
108,696
(1)
—
—
$ 55.2000
246,398
(2)
—
—
$ 197.5680
2,900
0.2
2,900
$ 217.9200
2,705
0.2
2,705
$ 380.8000
1,149
6.3
1,149
1,166,017
1.2
6,754
(1) These warrants become exercisable on January 21, 2025.
(2) These warrants become exercisable on January 1, 2025.
During the year ended December 31, 2024, Pre-Funded Warrants for the purchase of 152,905 shares of the Company’s common stock with an exercise price of $ 0.008 per share were exercised for aggregate proceeds of $ 1,223 .
F-28
EYENOVIA, INC.
NOTES TO THE FINANCIAL STATEMENTS
FOR THE YEARS ENDED DECEMBER 31, 2024 AND 2023
During the year ended December 31, 2023, warrants for the purchase of 28,162 shares of the Company’s common stock with an exercise price of $ 0.80 per share were exercised for aggregate proceeds of $ 22,529 .
Stock-Based Compensation Expense
The Company records stock-based compensation expense related to stock options and restricted stock units, or RSUs. For the years ended December 31, 2024 and 2023, the Company recorded stock-based compensation expense of $ 1,704,273 ($ 623,049 of which was included within research and development expenses and $ 1,081,224 was included within selling, general and administrative expenses on the statements of operations) and $ 2,497,890 ($ 839,038 of which was included within research and development expenses and $ 1,658,852 was included within selling, general and administrative expenses on the statements of operations), respectively.
Restricted Stock Units
A summary of the restricted stock units activity during the year ended December 31, 2024 is presented below:
Weighted
Average
Number of
Exercise
RSUs
Price
RSUs non-vested January 1, 2024
1,322
$
169.60
Granted
4,608
52.00
Vested
( 1,322 )
169.60
Forfeited
—
—
RSUs non-vested December 31, 2024
4,608
$
52.00
Vested RSUs undelivered December 31, 2024
3,015
$
173.90
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.
On June 12, 2024, the Company granted members of its Board of Directors an aggregate of 4,608 RSUs under the Restated Plan. Each RSU is subject to settlement into one share of the Company’s common stock. The RSUs vest on the earlier of (i) the one-year anniversary of the date of grant and (ii) the date of the 2025 annual stockholders meeting, subject to the grantee remaining on the Board until then. The RSUs had a grant date fair value of $ 239,772 , which will be recognized over the vesting period. In 2024, there were no shares of common stock issued related to vested RSUs.
Between June 27, 2023 and November 14, 2023, the Company granted members of its Board of Directors an aggregate of 1,322 RSUs under the Restated Plan. Each RSU is subject to settlement into one share of the Company’s common stock. The RSUs vest on the earlier of (i) the one-year anniversary of the date of grant and (ii) the date of the 2024 annual stockholders meeting, subject to the grantee remaining on the Board until then. The RSUs had a grant date fair value of $ 224,800 , which will be recognized over the vesting period. In 2023, there were 597 of common shares issued related to vested RSUs.
As of December 31, 2024, there was $ 109,897 of unrecognized stock-based compensation expense related to RSUs which will be recognized over a weighted average period of 0.45 years.
F-29
EYENOVIA, INC.
NOTES TO THE FINANCIAL STATEMENTS
FOR THE YEARS ENDED DECEMBER 31, 2024 AND 2023
Stock Options
A summary of the option activity during the year ended December 31, 2024 is presented below:
Weighted
Weighted
Average
Average
Remaining
Aggregate
Number of
Exercise
Life
Intrinsic
Options
Price
In Years
Value
Outstanding, January 1, 2024
66,329
$
264.85
—
—
Granted
27,351
87.86
—
—
Exercised
—
—
—
—
Forfeited
( 25,497 )
183.18
—
—
Outstanding, December 31, 2024
68,183
$
231.06
4.3
$
—
Exercisable, December 31, 2024
51,494
$
273.72
5.6
$
—
The following table presents information related to stock options as of December 31, 2024:
Options Outstanding
Options Exercisable
Weighted
Average
Exercise
Number of
Remaining Life
Number of
Price
Options
In Years
Options
$ 0.01 - $ 79.99
9,164
—
—
$ 80 - $ 159.99
21,253
5.4
15,026
$ 160 - $ 239.99
14,117
6.5
13,220
$ 240 - $ 319.99
9,321
5.7
9,068
$ 320 - $ 399.99
3,480
6.5
3,332
$ 400 - $ 479.99
332
1.8
332
$ 480 - $ 559.9
8,636
5.0
8,636
$ 560 +
1,880
3.2
1,880
68,183
5.6
51,494
In applying the Black-Scholes option pricing model to stock options granted, the Company used the following approximate assumptions:
For the Year Ended
December 31,
2024
2023
Expected term (years)
5.50 - 10.00
5.50 - 10.00
Risk free interest rate
3.47 % - 4.72 %
3.44 % - 4.72 %
Expected volatility
80 % - 87 %
80 % - 95 %
Expected dividends
0.00 %
0.00 %
The Company has computed the fair value of stock options granted using the Black-Scholes option pricing model. Option forfeitures are accounted for at the time of occurrence. The expected term used for options issued is the estimated period of time that options granted are expected to be outstanding. The Company utilizes the “simplified” method to develop an estimate of the expected term of “plain vanilla” option grants. The Company uses its historical volatility for the period from its initial public offering through the valuation date in computing the expected volatility. Accordingly, the Company is utilizing an expected volatility figure based on a review of its historical volatility 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
F-30
EYENOVIA, INC.
NOTES TO THE FINANCIAL STATEMENTS
FOR THE YEARS ENDED DECEMBER 31, 2024 AND 2023
the instrument being valued. The Company has not declared dividends, is currently in the development stage and has no plan to declare future dividends at this time.
The weighted average estimated grant date fair value of the stock options granted for the years ended December 31, 2024 and 2023 was approximately $ 63 and $ 132 per share, respectively.
As of December 31, 2024, there was $ 949,697 of unrecognized stock-based compensation expense related to stock options which will be recognized over a weighted average period of 1.3 years.
Note 13 – Employee Benefit Plans
401(k) Plan
In April 2019, the Company adopted the Eyenovia 401(k) Plan, or the Plan, which went into effect in May 2019. All Company employees are able to participate in the Plan, subject to eligibility requirements as outlined in the Plan documents. Under the terms of the Plan, eligible employees are able to defer a percentage of their pay every pay period up to annual limitations set by Congress and the Internal Revenue Service under Section 401(k) of the Internal Revenue Code. The Company’s Board of Directors approved a matching contribution equal to 100 % of elective deferrals up to 4 % of eligible earnings with the matching contribution subject to certain vesting requirements as outlined in the Plan documents. For the years ended December 31, 2024 and 2023, the Company recorded expense of $ 264,104 and $ 218,170 associated with its matching contributions, respectively.
Note 14 – Segment Reporting
The Company has one operating and reporting segment (ophthalmic technology), namely, the development and commercialization of ophthalmic solutions. The accounting policies of the segment are the same as those described in the summary of significant accounting policies. The chief operating decision maker (“CODM”), who is the Company’s chief executive officer, utilizes the Company’s financial information on an aggregate basis for purposes of making operating decisions, allocating resources and assessing financial performance, as well as for making strategic operations decisions and managing the organization. The measure of segment assets is reported on the balance sheet as total assets.
F-31
EYENOVIA, INC.
NOTES TO THE FINANCIAL STATEMENTS
FOR THE YEARS ENDED DECEMBER 31, 2024 AND 2023
The Company’s significant expenses reviewed by the CODM for the years ended December 31, 2024 and 2023 are as follows:
For the Years Ended
December 31,
2024
2023
Revenue:
Revenue
$
57,336
$
3,787
Less:
Cost of revenue
( 3,927,228 )
( 16,005 )
Gross Loss
( 3,869,892 )
( 12,218 )
Less:
Research and Development:
Salaries and benefits
6,215,323
6,869,585
Direct clinical and non-clinical expenses
3,072,416
714,995
Supplies and materials
2,195,608
1,762,676
Depreciation expense
1,112,463
776,479
Facilities expenses
834,406
1,442,001
Non-cash stock based compensation expenses
623,049
839,038
Other Expenses (1)
409,457
571,058
Selling General and Administrative:
Salaries and benefits
5,226,885
3,964,522
Professional fees
2,967,185
2,870,946
Non-cash stock based compensation
1,081,224
1,658,852
FDA PDUFA fees
853,434
933,284
Insurance expense
801,676
175,515
Sales and marketing
747,349
1,097,402
Investor relations
662,126
398,273
Travel, lodging and meals
564,311
104,183
Other Expenses (2)
535,115
305,270
Facilities expense
485,059
494,823
Director fees and expense
408,750
415,326
Reacquisition of license rights
4,864,600
—
Asset impairments
11,207,897
—
Total Expense:
44,868,333
25,394,227
Loss from Operations
( 48,738,225 )
( 25,406,445 )
Other (expense) income, net (3)
( 1,080,208 )
( 1,854,650 )
Net Loss
$
( 49,818,433 )
$
( 27,261,095 )
(1) Other research and development expenses include outsourced engineering and IT systems used for research and development.
(2) Other selling, general, and administrative expenses include, distribution for specialty pharmacy networks, Nasdaq / SEC fees, software services, corporate tax, and depreication expense.
(3) All other items include gains and losses in the change in fair value of equity consideration payable, interest expense, net of interest income, and other non operating expenses.
F-32
EYENOVIA, INC.
NOTES TO THE FINANCIAL STATEMENTS
FOR THE YEARS ENDED DECEMBER 31, 2024 AND 2023
Note 15 – Subsequent Events
January 2025 Offering
On January 16, 2025, the Company entered into an Inducement Offer (the “Inducement Offer”) with an Investor (the “Investor”), by which the Company agreed to reduce the exercise price of 197,118 existing warrants (“the Existing Warrants”) from $ 55.20 per share, to $ 5.272 per share. The Inducement Offer had a limited exercise period, until January 17, 2025, to exercise the Existing Warrants (the “Exercise Period”).
In connection with the Inducement Offer, if the Investor exercised the Existing Warrants within the Exercise Period, the Company agreed to issue 197,118 Series A Common Stock Purchase Warrants and 197,118 Series B Common Stock Purchase Warrants to purchase an additional 394,236 shares of common stock at an exercise price of $ 5.272 per share which may be exercised for five years from the initial exercise date. The warrants become exercisable upon stockholder approval.
On January 17, 2025, the Investor exercised the Existing Warrants within the Exercise Period. The aggregate gross cash proceeds to the Company from the inducement offer were approximately $ 1.0 million, and net cash proceeds after offering costs were approximately $ 0.9 million.
Stockholder Approval of 2024 Warrants
On January 21, 2025, in connection with the December Offering, the stockholders approved the exercise of the September Offering warrants, the November Offering warrants and the December Offering warrants (see Note 12 – Stockholders’ Equity - Offerings).
Reverse Stock Split
On January 31, 2025, the Company effected the Reverse Split of its common stock at a ratio of 1-for-80 . Upon the effectiveness of the Reverse Split, every 80 issued shares of common stock were reclassified and combined into one share of common stock. In addition, the number of shares of common stock issuable upon the exercise of the Company’s equity awards, convertible securities and warrants was proportionally decreased, and the corresponding conversion price or exercise price was proportionally increased. No fractional shares were issued as a result of the Reverse Split, stockholders who would otherwise be entitled to receive a fractional share will be entitled to receive a cash payment in lieu of such fractional share. Accordingly, all share and per share amounts for all periods presented in these financial statements and notes thereto have been adjusted retroactively, where applicable, to reflect the Reverse Split and adjustment of the conversion price or exercise price of each outstanding equity award, convertible security and warrant as if the transaction had occurred as of the beginning of the earliest period presented.
Avenue Ventures Loan Second Amendment
On February 21, 2025, the Company entered into a second amendment of the Avenue Loan Agreement (the “Second Amendment”) whereby the Lender agreed to defer principal and interest payments on amounts outstanding until the end of September 2025. Deferred interest will accrue on the outstanding principal amount at the interest rate stated in the original Avenue Loan.
Under the Second Amendment, the Company has agreed to use a portion of the proceeds (net of fees and commissions payable to Chardan) received from sales under the A&R Sales Agreement (the “A&R Proceeds”) to pay down the outstanding principal amount under the Avenue Loan Agreement as follows: a) until the Company raises $ 3.0 million of aggregate A&R Proceeds, 65 % of the A&R Proceeds shall be remitted to the Lenders as a payment in respect of the outstanding principal amount, and b) after the Company raises $ 3.0 million of aggregate A&R Proceeds, 75 % of the A&R Proceeds shall be remitted to the Lenders as a payment in respect of the outstanding principal amount.
Pursuant to the Second Amendment, at any time on or after April 1, 2025, the Lenders will also have the right, in their discretion, but not the obligation, to convert an aggregate amount of up to $ 10.0 million of the aggregate principal amount under the Avenue Loan Agreement into shares of the Company’s common stock, at a price equal to $ 1.68 per share.
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EYENOVIA, INC.
NOTES TO THE FINANCIAL STATEMENTS
FOR THE YEARS ENDED DECEMBER 31, 2024 AND 2023
Increase and Issuance of 2018 Omnibus Stock Incentive Plan Shares
On January 21, 2025, the stockholders approved an amendment to the Company’s Amended and Restated 2018 Omnibus Stock Incentive Plan to reserve an additional 350,000 shares of the Company’s common stock for issuance thereunder, which number will not be adjusted as a result of the Reverse Split.
On February 5, 2025, the Company granted 240,000 shares of restricted stock units in the aggregate to consultants and employees. The shares vest on the earliest of (i) one year from the date of issuance, (ii) a change in control of the Company, and (iii) with respect to employees, the date on which their employment with the Company is terminated, other than by such employee’s voluntary resignation.
At-The-Market Program
Subsequent to December 31, 2024, the Company received approximately $ 5.9 million in gross proceeds from the sale of 1,127,100 shares of its common stock pursuant to its Sales Agreement with Chardan in its “at-the-market” offering. In connection with the Second Amendment mentioned above, the Company paid Avenue $ 777,369 in gross proceeds received from the at-the-market offering, which was equivalent to 65 % of the proceeds raised from February 21, 2025 to March 31, 2025.
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