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 their evaluation, our principal executive officer and principal financial and accounting officer concluded that, as of December 31, 2022, 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, 2022.
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 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, 2022, 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 have concluded that our internal control over financial reporting was effective as of December 31, 2022.
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, 2022 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 established by the JOBS Act for emerging growth companies.
93
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Item 9B. Other Information.
None.
Item 9C. Disclosure Regarding Foreign Jurisdictions that Prevent Inspections
Not applicable.
94
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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 in our proxy statement related to the 2023 Annual Meeting of Stockholders currently scheduled to be held on June 12, 2023, or 2023 Proxy Statement, 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 2023 Proxy Statement.
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 2023 Proxy Statement.
The information required by this Item concerning compliance with Section 16(a) of the Exchange Act is incorporated by reference from the section of our 2023 Proxy Statement captioned “Delinquent Section 16(a) Reports.”
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” in our 2023 Proxy Statement.
Item 12. Security Ownership of Certain Beneficial Owners and Management and Related Stockholder Matters.
The following table provides information as of December 31, 2022 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
Plan Category
warrants, and rights
rights
reflected in column (a))
Equity compensation plans approved by security holders
2014 Equity Incentive Plan, as amended
945,888
$
3.06
104,342
Amended and Restated 2018 Omnibus Stock Incentive Plan
4,640,365
3.49
906,903
Equity compensation plans not approved by security holders
—
—
—
Total
5,586,253
$
3.42
1,011,245
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 2023 Proxy Statement.
95
Table of Contents
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” in our 2023 Proxy Statement.
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” in the proxy statement for the 2023 Annual Meeting of Stockholders.
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Table of Contents
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
3.2
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 A Warrant issued on March 24, 2020
8-K
001-38365
4.1
March 25, 2020
4.3
Form of Class b Warrant issued on March 24, 2020
8-K
001-38365
4.2
March 25, 2020
4.4
Form of Warrant issued on May 7, 2021
8-K
001-38365
4.1
May 10, 2021
4.5
Form of Pre-Funded Warrant issued on March 7, 2022
8-K/A
001-38365
4.1
March 9, 2022
4.6
Form of Warrant issued on March 7, 2022
8-K/A
001-38365
4.2
March 9, 2022
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
97
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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
10.2*
Master Consulting Services Agreement, dated November 4, 2014, between Eyenovia, Inc. and Private Medical Equity, Inc.
S-1
333-222162
10.10
December 19, 2017
10.3*
Executive Employment Agreement, dated February 15, 2019, by and between the Company and Tsontcho Ianchulev
8-K
001-38365
10.16
February 19, 2019
10.4*
Executive Employment Agreement, dated February 15, 2019, by and between the Company and John Gandolfo
8-K
001-38365
10.17
February 19, 2019
10.5*
Executive Employment Agreement, dated February 15, 2019, by and between the Company and John Gandolfo
8-K
001-38365
10.19
February 19, 2019
10.6
Form of Nondisclosure, Assignment of Inventions and Noncompetition Agreement
8-K
001-38365
10.21
February 19, 2019
10.7*
Eyenovia, Inc. 2014 Equity Incentive Plan, as amended
S-8
333-233278
10.14
August 14, 2019
10.8*
Form of Nonqualified Stock Option Agreement
S-8
333-233278
10.15
August 14, 2019
10.9
Registration Rights Agreement, dated March 23, 2020, between Eyenovia, Inc. and the investors named therein
8-K
001-38365
10.23
March 25, 2020
10.10
Promissory Note and Agreement dated May 3, 2020
8-K
001-38365
10.24
May 8, 2020
10.11*
Eyenovia, Inc. Amended and Restated 2018 Omnibus Stock Incentive Plan
8-K
001-38365
10.1
June 17, 2022
10.12*
Form of Notice of Stock Option Grant and Award Agreement
8-K
001-38365
10.14
June 14, 2018
10.13*
Form of Restricted Stock Award Agreement
8-K
001-38365
10.15
June 14, 2018
10.14#
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
10.15#
License Agreement by and between Eyenovia, Inc. and Bausch Health Ireland Limited, dated October 9, 2020
8-K
001-38365
10.1
October 13, 2020
98
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10.16*
First Amendment to Executive Employment Agreement, dated February 1, 2021, by and between the Company and Michael M. Rowe
8-K
001-38365
10.1
February 3, 2021
10.17#
Loan and Security Agreement, by and between Eyenovia, Inc. and Silicon Valley Bank, dated May 7, 2021
8-K
001-38365
10.1
May 10, 2021
10.18#
First Amendment to Loan and Security Agreement, by and between Eyenovia, Inc. and Silicon Valley Bank, dated September 29, 2021
10-Q
001-38365
10.3
November 12, 2021
10.19
Waiver Agreement, by and between Eyenovia, Inc. and Silicon Valley Bank, dated November 30, 2021
8-K
001-38365
10.1
December 3, 2021
10.20
Sales Agreement, by and between Eyenovia, Inc. and SVB Leerink LLC, dated December 14, 2021
S-3
333-261638
1.2
December 14, 2021
10.21
Securities Purchase Agreement by and between Eyenovia, Inc. and Armistice Capital Master Fund Ltd., dated March 3, 2022
8-K
001-38365
10.1
March 7, 2022
10.22
Director Compensation Policy
10-K
001-38365
10.22
March 30, 2022
10.23
Addendum to Executive Employment Agreement, dated March 10, 2022, by and between the Company and Tsontcho Ianchulev
10-K
001-38365
10.23
March 30, 2022
10.24
Addendum to Executive Employment Agreement, dated March 10, 2022, by and between the Company and John Gandolfo
10-K
001-38365
10.24
March 30, 2022
10.25
Addendum to Executive Employment Agreement, dated March 10, 2022, by and between the Company and Michael Rowe
10-K
001-38365
10.25
March 30, 2022
10.26
Third Amendment to Loan and Security Agreement, dated as of May 6, 2022, by and between Eyenovia, Inc. and Silicon Valley Bank.
8-K
001-38365
10.1
May 15, 2022
10.27*#
Employment Agreement, dated July 26, 2022, by and between Eyenovia, Inc, and Michael Rowe
10-Q
001-38365
10.2
August 11, 2022
99
Table of Contents
10.28*
Executive Chair Agreement, dated August 1, 2022, by and between, Eyenovia, Inc. and Tsontcho Ianchulev
10-Q
001-38365
10.3
August 11, 2022
10.29
Non-Employee Director Compensation Policy, as amended
10-Q
001-38365
10.1
November 14, 202
10.30
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.
--
--
--
Filed herewith
10.31
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.
--
--
--
Filed herewith
10.32
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.
--
--
--
Filed herewith
10.33
Employment Agreement, dated December 19, 2022, by and between Eyenovia, Inc. and Bren Kern
--
--
--
Filed herewith
23.1
Consent of Marcum LLP
--
--
--
Filed herewith
31.1
Certification of the Principal Executive Officer pursuant to Section 302 of the Sarbanes-Oxley Act of 2002
--
--
--
Filed herewith
31.2
Certification of the 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
100
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101
Inline interactive data files pursuant to Rule 405 of Regulation S-T: (i) Balance Sheets as of December 31, 2022 and 2021; (ii) Statements of Operations for the Years Ended December 31, 2022 and 2021; (iii) Statements of Changes in Stockholders’ Equity for the Years Ended December 31, 2022 and 2021; (iv) Statements of Cash Flows for the Years Ended December 31, 2022 and 2021; 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) is the type of information that the Company treats as private or confidential.
Item 16. Form 10-K Summary.
None.
101
Table of Contents
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: March 31, 2023
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
March 31, 2023
Michael Rowe
(Principal Executive Officer) and Director
/s/ John Gandolfo
Chief Financial Officer
March 31, 2023
John Gandolfo
(Principal Financial and Accounting Officer)
/s/ Tsontcho Ianchulev
Director
March 31, 2023
Tsontcho Ianchulev
/s/ Rachel Jacobson
Director
March 31, 2023
Rachel Jacobson
/s/ Charles E. Mather IV
Director
March 31, 2023
Charles E. Mather IV
/s/ Ram Palanki
Director
March 31, 2023
Ram Palanki
/s/ Ellen Strahlman
Director
March 31, 2023
Ellen Strahlman
102
Table of Contents
EYENOVIA, INC.
INDEX TO FINANCIAL STATEMENTS
Page
Number
Years Ended December 31, 2022 and 2021
Report of Independent Registered Public Accounting Firm (PCAOB ID: 688)
F-2
Balance Sheets as of December 31, 2022 and 2021
F-3
Statements of Operations for the Years Ended December 31, 2022 and 2021
F-4
Statements of Changes in Stockholders’ Equity for the Years Ended December 31, 2022 and 2021
F-5
Statements of Cash Flows for the Years Ended December 31, 2022 and 2021
F-6
Notes to Financial Statements
F-8
F-1
Table of Contents
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, 2022 and 2021, the related statements of operations, changes in stockholders’ equity and cash flows for each of the two years in the period ended December 31, 2022 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, 2022 and 2021, and the results of its operations and its cash flows for each of the two years in the period ended December 31, 2022, 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 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.
Change in Accounting Principle
As discussed in Note 2 and Note 9 to the financial statements, the Company has changed its method of accounting for leases in 2022 due to the adoption of the guidance in ASC Topic 842, Leases effective January 1, 2022.
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 audits. 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.
/s/ Marcum LLP
Marcum LLP
We have served as the Company’s auditor since 2017.
New York, NY
March 31, 2023
F-2
Table of Contents
EYENOVIA, INC.
Balance Sheets
December 31,
2022
2021
Assets
Current Assets:
Cash and cash equivalents
$
22,863,520
$
19,461,850
Deferred clinical supply costs
2,284,931
—
License fee and expense reimbursements receivable
1,183,786
1,805,065
Security deposits, current
119,550
—
Prepaid expenses and other current assets
1,190,719
734,942
Total Current Assets
27,642,506
22,001,857
Restricted cash
—
7,875,000
Property and equipment, net
1,295,115
1,271,225
Security deposits, non-current
80,874
119,035
Operating lease right-of-use asset
1,291,592
—
Equipment deposits
726,326
391,941
Total Assets
$
31,036,413
$
31,659,058
Liabilities and Stockholders’ Equity
Current Liabilities:
Accounts payable
$
1,428,283
$
1,614,104
Accrued compensation
1,747,191
1,543,618
Accrued expenses and other current liabilities
503,076
845,719
Deferred rent - current portion
—
18,685
Operating lease liabilities - current portion
484,882
—
Notes payable - current portion, net of debt discount of $ 33,885 and $ 349,632 as of December 31, 2022 and 2021, respectively
174,448
7,150,368
Convertible notes payable - current portion, net of debt discount of $ 33,885 and $ 0 as of December 31, 2022 and 2021, respectively
174,448
—
Total Current Liabilities
4,512,328
11,172,494
Deferred rent - non-current portion
—
19,949
Operating lease liabilities - non-current portion
907,644
—
Notes payable - non-current portion, net of debt discount of $ 813,229 and $ 0 as of December 31, 2022 and 2021, respectively
4,190,938
—
Convertible notes payable - non-current portion, net of debt discount of $ 813,229 and $ 0 as of December 31, 2022 and 2021, respectively
4,190,938
—
Total Liabilities
13,801,848
11,192,443
Commitments and contingencies (Note 9)
Stockholders' Equity:
Preferred stock, $ 0.0001 par value, 6,000,000 shares authorized;
0 shares issued and outstanding as of December 31, 2022 and 2021, respectively
—
—
Common stock, $ 0.0001 par value, 90,000,000 shares authorized; 36,668,980 and 28,426,616 shares issued and outstanding as of December 31, 2022 and 2021, respectively
3,667
2,844
Additional paid-in capital
135,461,361
110,683,077
Accumulated deficit
( 118,230,463 )
( 90,219,306 )
Total Stockholders’ Equity
17,234,565
20,466,615
Total Liabilities and Stockholders’ Equity
$
31,036,413
$
31,659,058
The accompanying notes are an integral part of these financial statements.
F-3
Table of Contents
EYENOVIA, INC.
Statements of Operations
For the Years Ended
December 31,
2022
2021
Operating Income
Revenue
$
—
$
14,000,000
Cost of revenue
—
( 1,600,000 )
Gross Profit
—
12,400,000
Operating Expenses:
Research and development
13,378,680
14,850,874
General and administrative
13,532,835
10,569,653
Total Operating Expenses
26,911,515
25,420,527
Loss From Operations
( 26,911,515 )
( 13,020,527 )
Other Income (Expense):
Extinguishment of PPP 7(a) loan
—
463,353
Other income, net
197,090
164,027
Interest expense
( 1,380,058 )
( 387,756 )
Interest income
83,326
2,516
Net Loss
$
( 28,011,157 )
$
( 12,778,387 )
Net Loss Per Share - Basic and Diluted
$
( 0.83 )
$
( 0.49 )
Weighted Average Number of Common Shares Outstanding - Basic and Diluted
33,649,747
26,324,081
The accompanying notes are an integral part of these financial statements.
F-4
Table of Contents
EYENOVIA, INC.
Statements of Changes in Stockholders’ Equity
For the Years Ended December 31, 2022 and 2021
Additional
Total
Common Stock
Paid-In
Accumulated
Stockholders'
Shares
Amount
Capital
Deficit
Equity
Balance - January 1, 2021
24,978,585
$
2,498
$
92,742,306
$
( 77,440,919 )
$
15,303,885
Issuance of common stock in At the Market offering [1]
2,435,604
244
12,401,675
—
12,401,919
Exercise of stock warrants
885,482
89
2,124,815
—
2,124,904
Exercise of stock options
121,261
12
203,114
—
203,126
Shares withheld from option exercise for employee tax liability
( 13,675 )
( 1 )
( 26,323 )
—
( 26,324 )
Issuance of SVB warrants [2]
—
—
351,390
—
351,390
Stock-based compensation
—
—
2,886,102
—
2,886,102
Issuance of common stock related to vested restricted stock units
19,359
2
( 2 )
—
-
Net loss
—
—
—
( 12,778,387 )
( 12,778,387 )
Balance - December 31, 2021
28,426,616
2,844
110,683,077
( 90,219,306 )
20,466,615
Issuance of common stock and warrants in direct offering [3]
3,000,000
300
14,897,608
—
14,897,908
Issuance of common stock in debt financing [4]
547,807
54
859,679
—
859,733
Origination costs related to equity in debt financing
—
—
( 44,375 )
—
( 44,375 )
Issuance of common stock in At the Market offering [5]
2,716,061
271
5,281,505
—
5,281,776
Exercise of stock warrants
1,870,130
187
18,514
—
18,701
Stock-based compensation
—
—
3,765,364
—
3,765,364
Issuance of common stock related to vested restricted stock units
108,366
11
( 11 )
—
—
Net loss
—
—
—
( 28,011,157 )
( 28,011,157 )
Balance - December 31, 2022
36,668,980
$
3,667
$
135,461,361
$
( 118,230,463 )
$
17,234,565
[1] Includes gross proceeds of $ 12,785,483 , less total issuance costs of $ 383,564 .
[2] Allocated fair value of warrants of $ 354,539 , less allocated issuance costs of $ 3,149 .
[3] Includes gross proceeds of $ 14,981,299 less total issuance costs of $ 83,391 .
[4] Relative fair value of stock issued in connection with debt.
[5] Includes gross proceeds of $ 5,445,130 , less total issuance costs of $ 163,354 .
The accompanying notes are an integral part of these financial statements.
F-5
Table of Contents
EYENOVIA, INC.
Statements of Cash Flows
For the Years Ended
December 31,
2022
2021
Cash Flows From Operating Activities
Net loss
$
( 28,011,157 )
$
( 12,778,387 )
Adjustments to reconcile net loss to net cash
used in operating activities:
Stock-based compensation
3,765,364
2,886,102
Depreciation of property and equipment
307,430
221,563
Amortization of debt discount
411,918
68,376
Write-off of property and equipment
209,040
—
Gain on forgiveness of PPP 7(a) Loan
—
( 463,353 )
Non-cash rent expense
474,778
—
Expense reimbursement
—
( 51,588 )
Gain on disposal of property and equipment
—
( 55,194 )
Changes in operating assets and liabilities:
Prepaid expenses and other current assets
219,555
423,896
License fee and expense reimbursements receivables
621,279
1,397,924
Deferred clinical supply costs
( 2,284,931 )
—
Deferred license costs
—
1,600,000
Security deposits
( 81,389 )
—
Accounts payable
( 185,821 )
126,115
Accrued compensation
203,573
392,946
Accrued expenses and other current liabilities
( 342,643 )
( 634,973 )
Deferred license fee
—
( 14,000,000 )
Deferred rent
—
( 7,859 )
Lease liabilities
( 412,478 )
Net Cash Used In Operating Activities
( 25,105,482 )
( 20,874,432 )
Cash Flows From Investing Activities
Purchases of property and equipment
( 540,360 )
( 1,226,576 )
Vendor deposits for property and equipment
( 334,385 )
( 391,941 )
Net Cash Used In Investing Activities
( 874,745 )
( 1,618,517 )
Cash Flows From Financing Activities
Proceeds from sale of common stock and warrants in direct offering [1]
14,981,299
—
Payment of issuance costs in registered direct offering
( 83,391 )
—
Proceeds from sale of common stock in At the Market offering
5,445,130
12,785,483
Payment of issuance costs for At the Market offering
( 163,354 )
( 383,564 )
Proceeds from exercise of stock warrants
18,701
2,124,904
Proceeds from SVB loan
—
7,500,000
Payment of SVB loan issuance costs
—
( 66,618 )
Proceeds from notes and equity issued to Avenue
10,000,000
—
Payment of issuance costs for equity issued to Avenue
( 46,836 )
—
Payment of issuance costs for notes issued to Avenue
( 469,320 )
—
Repayments of notes payable
( 8,175,332 )
( 705,360 )
Proceeds from exercise of stock options
—
203,126
Net Cash Provided By Financing Activities
21,506,897
21,457,971
Net Decrease in Cash and Cash Equivalents
( 4,473,330 )
( 1,034,978 )
Cash and cash equivalents - Beginning of Year
27,336,850
28,371,828
Cash and cash equivalents - End of Year
$
22,863,520
$
27,336,850
[1] Includes gross proceeds of $ 14,981,299 , of which $ 5,741,299 is pre-funded warrants.
F-6
Table of Contents
Cash, cash equivalents and restricted cash consisted of the following:
Cash and cash equivalents
22,863,520
$
19,461,850
Restricted cash
—
7,875,000
$
22,863,520
$
27,336,850
Supplemental Disclosure of Cash Flow Information:
Cash paid during the year for:
Interest
$
315,550
$
227,171
Supplemental Disclosure of Non-Cash Investing and Financing Activities
Purchase of insurance premium financed by note payable
675,332
$
705,360
Recognition of right-of-use asset for lease liability upon adoption of ASU 2016-02
618,906
$
—
Right-of-use assets obtained in exchange for lease liabilities
1,186,098
$
—
Shares withheld from option exercise for employee tax liability
—
$
26,324
Warrants issued for debt issuance costs
—
$
351,390
Common shares issued recorded as debt discount for Avenue Loan
859,733
$
—
Issuance of common stock related to vested restricted stock units
11
$
2
The accompanying notes are an integral part of these financial statements.
F-7
Table of Contents
EYENOVIA, INC.
NOTES TO THE FINANCIAL STATEMENTS
FOR THE YEARS ENDED DECEMBER 31, 2022 AND 2021
Note 1 – Business Organization and Nature of Operations
Eyenovia, Inc., or Eyenovia or the Company, is a pre-commercial ophthalmic technology company developing the Optejet® delivery system for use both in combination with its own drug-device therapeutic programs as well as out-licensing for additional indications. Eyenovia’s aim is to improve the delivery of topical ophthalmic medication through ergonomic design that facilitates ease-of-use and delivery of more physiologically appropriate medication volume, with the goal to reduce side effects and improve tolerability, and introduce digital health technology to improve therapy compliance and ultimately medical outcomes. The ergonomic and functional design of the Optejet® allows for horizontal drug delivery and eliminates the need to tilt the head back or the manual dexterity to squeeze a bottle to administer medications. Drug is delivered in a microscopic array of droplets faster than the blink reflex to help ensure instillation success. The precise delivery of a low-volume columnar spray by the Optejet® device minimizes contamination with a non-protruding nozzle and self-closing shutter. In clinical trials, the Optejet® has demonstrated that its targeted delivery achieves a high rate of successful administration, with 98 % of sprays being accurately delivered upon first attempt compared to the established rate reported with traditional eye drops of ~ 50 %. A more physiologically appropriate volume of medication in the range of seven to nine microliters is delivered by the Optejet, approximately one fifth of the 35 to 50 microliter dose typically delivered in a single eye drop. Lower volume of medication exposes the ocular surface to less active ingredient and preservatives, potentially reducing ocular stress and surface damage and improving tolerability. The lower volume also minimizes the potential for drug to enter systemic circulation, with the goal of avoiding some common side effects that are related to overdosing of the eye. Versions of the Optejet are being developed with on-board digital technology to provide reminders via Bluetooth to smart devices and date and time stamp device use. This information can then be used by practitioners and health care systems to measure treatment compliance and improve medical decision making. In this way, the Optejet could serve as an extension of the physician’s office by providing information that is not currently possible to collect except through the use of diaries. To address unmet medical needs, the Company is developing the next generation of smart ophthalmic therapeutics to target new indications or new combinations where there are currently no or few drug therapies approved by the U.S. Food and Drug Administration, or FDA. The Company’s investigational products are classified by the FDA as drug-device combination products with drug primary mode of action, meaning that the Center for Drug Evaluation and Research, or CDER, is designated as the lead center with primary jurisdictional oversight. Accordingly, the product candidates are submitted to the FDA and CDER for premarket review and approval under new drug applications, or NDAs.
Note 2 – Summary of Significant Accounting Policies
Liquidity and Going Concern
As of December 31, 2022, the Company had unrestricted cash and cash equivalents of approximately $ 22.9 million and an accumulated deficit of approximately $ 118.2 million. For the years ended December 31, 2022 and 2021, the Company incurred net losses of approximately $ 28.0 million and $ 12.8 million, respectively, and used cash in operations of approximately $ 25.1 million and $ 20.9 million, respectively. The Company does not have recurring revenue and has not yet achieved profitability. The Company expects to continue to incur cash outflows from operations for the near future. The Company expects that its research and development and general and administrative expenses will continue to increase and, as a result, it will eventually need to generate significant product revenues to achieve profitability. These circumstances raise substantial doubt about the Company’s ability to continue as a going concern for at least one year from the date that these financial statements are issued. Implementation of the Company’s plans and its ability to continue as a going concern will depend upon the Company’s ability to generate sufficient recurring revenues or the Company’s ability to raise further capital, through the sale of additional equity or debt securities or otherwise, to support its future operations.
The Company’s operating needs include the planned costs to operate its business, including amounts required to fund working capital and capital expenditures. The Company’s future capital requirements and the adequacy of its available funds will depend on many factors, including the Company’s ability to successfully commercialize its products and services, competing technological and market developments, and the need to enter into collaborations with other companies or acquire other companies or technologies to enhance or complement its product and service offerings. If the Company is unable to generate sufficient recurring revenues or secure additional capital, it may be required to curtail its research and development initiatives and take additional measures to reduce costs in order to conserve its cash.
Use of Estimates
Preparation of financial statements in conformity with accounting principles generally accepted in the United States of America, or U.S. GAAP, requires management to make estimates, judgments and assumptions that affect the amounts reported in the financial statements and the amounts disclosed in the related notes to the financial statements. The Company bases its estimates and judgments on historical experience and on various other assumptions that it believes are reasonable under the circumstances. The amounts of assets and liabilities
Table of Contents
EYENOVIA, INC.
NOTES TO THE FINANCIAL STATEMENTS
FOR THE YEARS ENDED DECEMBER 31, 2022 AND 2021
reported in the Company’s balance sheets and the amounts of expenses reported for each of the periods presented are affected by estimates and assumptions, which are used for, but not limited to, fair value calculations for equity securities, establishment of valuation allowances for deferred tax assets, revenue recognition, the recoverability and useful lives of long-lived assets, the recovery of deferred costs and the deferral of revenues. Certain of the Company’s estimates could be affected by external conditions, including those unique to the Company and general economic conditions. It is reasonably possible that actual results could differ from those estimates.
See Note 2 - Summary of Significant Accounting Policies — Stock-Based Compensation for additional discussion of the use of estimates in estimating the fair value of the Company’s common stock.
Reclassifications
Certain prior period balances have been reclassified in order to conform to current period presentation. These reclassifications have no effect on previously reported results of operations or loss per share.
Cash, Cash Equivalents and Restricted Cash
The Company considers all highly liquid investments with an original maturity of three months or less to be cash equivalents in the financial statements.
Cash and cash equivalents that are restricted as to withdrawal or use under the terms of certain executed agreements are recorded as restricted cash on the balance sheets. As of December 31, 2021, the Company had restricted cash in the amount of $ 7,875,000 , which consisted of cash held in a money market account pledged as collateral for a note payable to Silicon Valley Bank, or the SVB Loan. The restricted cash was used in the repayment of the SVB Loan in November 2022. See Note 7 – Notes Payable and Convertible Notes Payable – Silicon Valley Bank Loan. As of December 31, 2022 and 2021, the Company had cash and cash equivalent balances in excess of FDIC insurance limits of $ 22,613,520 and $ 19,211,850 , respectively.
On March 10, 2023, Silicon Valley Bank, or SVB, was closed by the California Department of Financial Protection and Innovation, and the Federal Deposit Insurance Corporation, or FDIC, was appointed as receiver. The Company has a deposit account at SVB. The standard deposit insurance amount is up to $ 250,000 per depositor, per insured bank, for each account ownership category. As of the date of filing, the Company had approximately $ 194,000 in a deposit account at SVB.
Property and Equipment, Net
Property and equipment are stated at cost, net of accumulated depreciation, which is recorded commencing at the in-service date using the straight-line method at rates sufficient to charge the cost of depreciable assets to operations over their estimated useful lives, which range from 1 to 10 years . Leasehold improvements are amortized over the lesser of (a) the useful life of the asset; or (b) the remaining lease term. Maintenance and repairs are charged to operations as incurred. The Company capitalizes costs attributable to the betterment of property and equipment when such betterment extends the useful life of the assets.
Impairment of Long-lived Assets
The Company reviews for the impairment of long-lived assets whenever events or changes in circumstances indicate that the carrying amount of an asset might not be recoverable. An impairment would be recognized when estimated future cash flows expected to result from the use of the asset and its eventual disposition are less than its carrying amount. The Company did not record any impairment losses during the years ended December 31, 2022 and 2021.
Fair Value of Financial Instruments
The Company measures the fair value of financial assets and liabilities based on Accounting Standards Codification, or ASC Topic 820 “Fair Value Measurements and Disclosures”, or ASC 820, which defines fair value, establishes a framework for measuring fair value, and expands disclosures about fair value measurements.
F-9
Table of Contents
EYENOVIA, INC.
NOTES TO THE FINANCIAL STATEMENTS
FOR THE YEARS ENDED DECEMBER 31, 2022 AND 2021
ASC 820 defines fair value as the exchange price that would be received for an asset or paid to transfer a liability (an exit price) in the principal or most advantageous market for the asset or liability in an orderly transaction between market participants on the measurement date. ASC 820 also establishes a fair value hierarchy, which requires an entity to maximize the use of observable inputs and minimize the use of unobservable inputs when measuring fair value. ASC 820 describes three levels of inputs that may be used to measure fair value:
Level 1 — quoted prices in active markets for identical assets or liabilities;
Level 2 — quoted prices for similar assets and liabilities in active markets or inputs that are observable; and
Level 3 — inputs that are unobservable (for example, cash flow modeling inputs based on assumptions).
The carrying amounts of the Company’s financial instruments, such as cash and cash equivalents, restricted cash, accounts payable, and notes payable approximate fair values due to the short-term nature or effective interest rates of these instruments.
Income Taxes
The Company is subject to Federal, New York State and City, and State of California income taxes and files tax returns in those jurisdictions.
The Company recognizes deferred tax assets and liabilities for the expected future tax consequences of items that have been included or excluded in the financial statements or tax returns. Deferred tax assets and liabilities are determined on the basis of the difference between the tax basis of assets and liabilities and their respective financial reporting amounts, or temporary differences, at enacted tax rates in effect for the years in which such temporary differences are expected to reverse.
The Company utilizes a recognition threshold and measurement process for financial statement recognition and measurement of a tax position taken or expected to be taken in a tax return.
The Company’s policy is to classify assessments, if any, for tax-related interest as interest expense and penalties as general and administrative expenses in the statements of operations.
Revenue Recognition
The Company’s revenues are generated primarily through research, development and commercialization agreements. The terms of such agreements may contain multiple promised goods and services, which may include (i) licenses to its intellectual property, and (ii) in certain cases, payment in connection with the manufacturing and delivery of clinical supply materials. Payments to us under these arrangements typically include one or more of the following: non-refundable, upfront license fees; milestone payments; payments for clinical product supply, and royalties on future product sales.
The Company analyzes its arrangements to assess whether such arrangements involve joint operating activities. For collaboration arrangements that are deemed to be within the scope of ASC Topic 808, “Collaborative Arrangements”, or ASC 808, the Company allocates the contract consideration between such joint operating activities and elements that are reflective of a vendor-customer relationship and, therefore, within the scope of ASC Topic 606, “Revenue from Contracts with Customers”, or ASC 606. The Company’s policy is to recognize amounts allocated to joint operating activities as a reduction in research and development expense.
Under ASC 606, the Company recognizes revenue when its customers obtain control of promised goods or services, in an amount that reflects the consideration the Company expects to receive in exchange for those goods or services. To determine revenue recognition for arrangements that the Company determines are within the scope of ASC 606, the Company performs the following five steps:
● Step 1: Identify the contract with the customer;
● Step 2: Identify the performance obligations in the contract;
F-10
Table of Contents
EYENOVIA, INC.
NOTES TO THE FINANCIAL STATEMENTS
FOR THE YEARS ENDED DECEMBER 31, 2022 AND 2021
● Step 3: Determine the transaction price;
● Step 4: Allocate the transaction price to the performance obligations in the contract; and
● Step 5: Recognize revenue when the company satisfies a performance obligation.
The Company must make significant judgments in its revenue recognition process, including identifying performance obligations in the contract, estimating the amount of variable consideration to include in the transaction price and allocating the transaction price to each performance obligation. Milestone payments represent variable consideration that will be recognized when the performance obligation is achieved. Sales-based royalty payments derived from usage of intellectual property are recognized when those sales occur.
Arrangements that include rights to additional goods or services that are exercisable at a customer’s discretion are generally considered discretionary purchase options. The Company assesses if these options provide a material right to the customer and if so, they are considered performance obligations.
During 2020, the Company entered into a license agreement, or the Arctic Vision License Agreement, with Arctic Vision (Hong Kong) Limited, or Arctic Vision, and a license agreement, or the Bausch License Agreement, with Bausch Health Companies, Inc., or Bausch + Lomb. Each license has three revenue components:
1) an upfront license fee;
2) milestone payments and
3) royalty payments.
Arctic Vision License Agreement
On August 10, 2020, the Company entered into the Arctic Vision License Agreement pursuant to which Arctic Vision may develop and commercialize MicroPine for the treatment of progressive myopia and MicroLine for the treatment of presbyopia in Greater China (mainland China, Hong Kong, Macau and Taiwan) and South Korea. On September 14, 2021, the Company and Arctic Vision executed Amendment 1 to the Arctic Vision License Agreement, or Arctic Vision Amendment 1, pursuant to which Arctic Vision may develop and commercialize MicroStat for the treatment of mydriasis in Greater China and South Korea.
Upfront License Fees
During the year ended December 31, 2021, the Company recognized $ 4.0 million in revenue, pursuant to the Arctic Vision license agreement, upon the submission of certain trial data to Arctic Vision, permitting Arctic Vision to seek regulatory approval with the National Medical Products Administration of China.
Pursuant to the terms of the Senju License Agreement (see Note 10 – Related Party Transactions) the Company is required to pay Senju a percentage of payments received from Arctic Vision. Accordingly, the Company paid $ 1.6 million to Senju in connection with the $ 4.0 million upfront license fees received from Arctic Vision, which is reflected as cost of revenue in the accompanying statements of operations. In connection with Arctic Vision Amendment 1, Arctic Vision paid the Company a $ 250,000 upfront fee, which in turn, the Company paid to Senju in connection with Senju Amendment 2 (see Note 10 – Related Party Transactions). The Company did not recognize revenue for the $ 250,000 upfront payment because it was passed through to Senju.
Milestone Payments
The Company may receive an additional $ 37.7 million in milestone payments in connection with the Arctic Vision License Agreement, as amended, based on various development and regulatory milestones, including the initiation of clinical research and regulatory approvals in Greater China and South Korea, related to the filing of Marketing Authorization Applications of approximately $ 13.2 million and the receipt of regulatory approvals of approximately $ 24.5 million. The Company currently anticipates the remaining milestone related performance obligations to be achieved between late 2024 and late 2025.
F-11
Table of Contents
EYENOVIA, INC.
NOTES TO THE FINANCIAL STATEMENTS
FOR THE YEARS ENDED DECEMBER 31, 2022 AND 2021
Royalty Payments
Arctic Vision also will purchase its supply of MicroPine, MicroLine and MicroStat from the Company or, for such products not supplied by the Company, pay the Company a mid-single digit percentage royalty on net sales of such products, subject to certain adjustments. No royalty payments were earned through December 31, 2022. The Company will pay a percentage in the range from 30 % to 40 % of such payments, royalties, or net proceeds of such supply to Senju pursuant to the Senju License Agreement. See Note 10—Related Party Transactions—Senju License Agreement for additional details.
Bausch License Agreement
On October 9, 2020, the Company entered into the Bausch License Agreement pursuant to which Bausch + Lomb may develop and commercialize the Bausch Licensed Product in the Licensed Territory. Bausch + Lomb may terminate the Bausch License Agreement, with respect to the Bausch Licensed Product to either country in the Licensed Territory, at any time for convenience upon 90 days ’ written notice. Both parties have the right to terminate the Bausch License Agreement in the event of (i) an uncured material breach after a 60-day period or (ii) a bankruptcy event.
Upfront License Fees
During the year ended December 31, 2021, the Company recognized revenue of $ 10.0 million upon the submission of certain trial to Bausch + Lomb and the transfer of supervisory oversight of the clinical trial to Bausch + Lomb, permitting Bausch + Lomb to assume supervisory oversight of the ongoing MicroPine study, or the CHAPERONE study.
Milestone Payments
Bausch + Lomb could also pay the Company up to an aggregate of approximately $ 35.0 million in additional payments, depending on the achievement of certain regulatory and launch-based milestones. No milestone payments were earned through December 31, 2022. The Company currently anticipates that the aforementioned milestone payments will be earned between late 2024 and late 2025.
Royalty Payments
Under the terms of the Bausch License Agreement, on a country-to-country basis and Bausch Licensed Product-by- Bausch Licensed Product basis, Bausch + Lomb will pay the Company royalties on a tiered basis (ranging from mid-single digit to mid-teen percentages) on gross profits from the sales of the Bausch Licensed Product in the Licensed Territory, subject to certain adjustments in the event of generic entry, negative gross profits or patent expiration, for a period of the later to occur of the 10th anniversary of the first commercial sale of a Bausch Licensed Product in such country in the Licensed Territory or the expiration of the last valid patent claim for a Bausch Licensed Product in such country in the Licensed Territory. No royalty payments were earned through December 31, 2022.
Clinical Supply Arrangements
Bausch + Lomb and Arctic Vision have contracted with the Company to manufacture and supply them with the appropriate drug-device combination products to conduct their clinical trials on a cost plus 10 % mark-up basis. Our licensing agreements with Bausch + Lomb and Arctic Vision represent collaborative arrangements and they are not a customer with respect to the clinical supply arrangements. The Company’s policy is to (a) defer the materials and manufacturing costs in order to properly match them up against the income from the clinical supply arrangements; and (b) to report the net income from the clinical supply arrangements as other income. Deferred clinical supply costs were $ 2.3 million at December 31, 2022. Net income from the sale of clinical supplies was included in other income and amounted to $ 0.2 million for the year ended December 31, 2022.
Operating Leases
The Company adopted the Accounting Standards Update, or ASU 2016-02,“Leases (Topic 842)” as of December 31, 2022, effective January 1, 2022. The Company leases its facilities under non-cancellable operating leases. The Company evaluates the nature of each lease at the inception of an arrangement to determine whether it is an operating or financing lease and recognizes the ROU asset and lease liabilities based on the present value of future minimum lease payments over the expected lease term. The Company recognizes a
F-12
Table of Contents
EYENOVIA, INC.
NOTES TO THE FINANCIAL STATEMENTS
FOR THE YEARS ENDED DECEMBER 31, 2022 AND 2021
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 11 – Stockholders’ Equity – Stock Options for additional information related to estimating the fair value of stock options.
F-13
Table of Contents
EYENOVIA, INC.
NOTES TO THE FINANCIAL STATEMENTS
FOR THE YEARS ENDED DECEMBER 31, 2022 AND 2021
Net Loss Per Share of Common Stock
Basic net loss per share of common stock is computed by dividing net loss by the weighted average number of shares of common stock outstanding during the period. Diluted loss per share reflects the potential dilution that could occur if securities or other instruments to issue common stock were exercised or converted into common stock. The following table presents the computation of basic and diluted net loss per common share:
For the Years Ended
December 31,
2022
2021
Numerator:
Net income (loss)
$
( 28,011,157 )
$
( 12,778,387 )
Net loss attributable to common stockholders
$
( 28,011,157 )
$
( 12,778,387 )
Denominator (weighted average quantities):
Common shares issued
33,252,644
26,238,134
Add: Prefunded warrants
333,037
—
Add: Undelivered vested restricted shares
64,066
85,947
Denominator for basic and diluted net loss per share
33,649,747
26,324,081
Basic and diluted net loss per share of common stock
$
( 0.83 )
$
( 0.49 )
The following securities are excluded from the calculation of weighted average dilutive shares of common stock because their inclusion would have been anti-dilutive:
December 31,
2022
2021
Warrants
6,087,845
1,217,715
Options
5,380,553
4,377,398
Restricted stock units
172,800
41,778
Total potentially dilutive shares
11,641,198
5,636,891
Subsequent Events
The Company has evaluated subsequent events through the date which the financial statements were issued. Based upon the evaluation, the Company did not identify any recognized or non-recognized subsequent events that would have required adjustment or disclosure in the financial statements, except as disclosed.
Recently Adopted Accounting Standards
On May 3, 2021, the Financial Accounting Standards Board, or the FASB, issued ASU No. 2021-04, “Earnings Per Share (Topic 260), Debt—Modifications and Extinguishments (Subtopic 470-50), Compensation—Stock Compensation (Topic 718), and Derivatives and Hedging—Contracts in Entity’s Own Equity (Subtopic 815-40): Issuer’s Accounting for Certain Modifications or Exchanges of Freestanding Equity-Classified Written Call Options.” This new standard provides clarification and reduces diversity in an issuer’s accounting for modifications or exchanges of freestanding equity-classified written call options (such as warrants) that remain equity classified after modification or exchange. This standard is effective for fiscal years beginning after December 15, 2021, including interim periods within those fiscal years. Issuers should apply the new standard prospectively to modifications or exchanges occurring after the effective date of the new standard. The Company adopted ASU 2021-04 effective January 1, 2022. This standard did not have a material impact on the Company’s financial position, results of operations or cash flow.
F-14
Table of Contents
EYENOVIA, INC.
NOTES TO THE FINANCIAL STATEMENTS
FOR THE YEARS ENDED DECEMBER 31, 2022 AND 2021
In February 2016, the FASB issued ASU 2016-02 “Leases (Topic 842)”, or ASU 2016-02. ASU 2016-02 requires that a lessee recognize the assets and liabilities that arise from operating leases. A lessee should recognize in the statement of financial position a liability to make lease payments (the lease liability) and a right-of-use asset representing its right to use the underlying asset for the lease term. ASU 2016-02, as amended, is now effective for emerging growth companies for fiscal years beginning after December 15, 2021, and interim periods within fiscal years beginning after December 15, 2022. The Company adopted ASU 2016-02 on December 31, 2022, effective January 1, 2022 and the adoption of this ASU had a material impact on the Company’s financial statements, primarily as a result of recording right-of-use assets and lease liabilities for its operating leases in the approximate amounts of $ 580,000 and $ 619,000 , and derecognizing deferred rent in the approximate amount of $ 39,000 .
Recently Issued Accounting Standards
In June 2016, the FASB issued ASU No. 2016-13 “Financial Instruments - Credit Losses (Topic 326)” and also issued subsequent amendments to the initial guidance under ASU 2018-19, ASU 2019-04 and ASU 2019-05 (collectively Topic 326). Topic 326 requires the measurement and recognition of expected credit losses for financial assets held at amortized cost. This replaces the existing incurred loss model with an expected loss model and requires the use of forward-looking information to calculate credit loss estimates. The Company will be required to adopt the provisions of this ASU on January 1, 2023, with early adoption permitted for certain amendments. Topic 326 must be adopted by applying a cumulative effect adjustment to retained earnings. The adoption of Topic 326 is not expected to have a material impact on the Company’s financial position, results of operations or cash flows.
In August 2020, the FASB issued ASU 2020-06, Debt—Debt with Conversion and Other Options (Subtopic 470-20) and Derivatives and Hedging— Contracts in Entity’s Own Equity (Subtopic 815-40): Accounting for Convertible Instruments and Contracts in an Entity’s Own Equity, to clarify the accounting for certain financial instruments with characteristics of liabilities and equity. The amendments in this update reduce the number of accounting models for convertible debt instruments and convertible preferred stock by removing the cash conversion model and the beneficial conversion feature model. Limiting the accounting models will result in fewer embedded conversion features being separately recognized from the host contract. Convertible instruments that continue to be subject to separation models are (1) those with embedded conversion features that are not clearly and closely related to the host contract, that meet the definition of a derivative, and that do not qualify for a scope exception from derivative accounting and (2) convertible debt instruments issued with substantial premiums for which the premiums are recorded as paid-in-capital. In addition, this ASU improves disclosure requirements for convertible instruments and earnings-per-share guidance. The ASU also revises the derivative scope exception guidance to reduce form-over-substance-based accounting conclusions driven by remote contingent events. The amendments in this update are effective for the Company in fiscal years beginning after December 15, 2023, and interim periods within those fiscal years. Early adoption is permitted, but not earlier than for fiscal years beginning after December 15, 2020. The Company early adopted ASU 2020-06 effective January 1, 2023 which eliminates the need to assess whether a beneficial conversion feature needs to be recognized upon the issuance of new convertible instruments. The adoption of ASU 2020-06 is not expected to have a material impact on the Company’s financial position, results of operations or cash flows.
Note 3 – Prepaid Expenses and Other Current Assets
As of December 31, 2022 and 2021, prepaid expenses and other current assets consisted of the following:
December 31,
2022
2021
Payroll tax receivable
$
660,891
$
343,785
Prepaid insurance expenses
201,082
171,370
Prepaid conference expenses
97,743
12,586
Prepaid general and administrative expenses
87,982
71,375
Prepaid rent and security deposit
74,959
32,254
Prepaid patent expenses
38,796
32,797
Other
26,745
4,525
Prepaid research and development expenses
2,521
—
Prepaid board of directors fees
—
66,250
Total prepaid expenses and other current assets
$
1,190,719
$
734,942
F-15
Table of Contents
EYENOVIA, INC.
NOTES TO THE FINANCIAL STATEMENTS
FOR THE YEARS ENDED DECEMBER 31, 2022 AND 2021
Note 4 - Property and Equipment, Net
As of December 31, 2022 and 2021, property and equipment consisted of the following:
December 31,
2022
2021
Equipment
$
1,271,372
$
854,060
Equipment not yet placed in service
90,411
254,864
Leasehold improvements
569,170
490,709
1,930,953
1,599,633
Less: accumulated depreciation and amortization
( 635,838 )
( 328,408 )
Property and equipment, net
$
1,295,115
$
1,271,225
Depreciation expense was $ 307,430 and $ 221,563 for the years ended December 31, 2022 and 2021, respectively, of which $ 301,205 and $ 211,604 , respectively, was included within research and development expenses and $ 6,225 and $ 9,959 , respectively, was included in general and administrative expenses in the accompanying statements of operations.
As of December 31, 2022 and 2021, the Company had $ 726,326 and $ 391,941 of outstanding deposits for equipment purchases.
Note 5 – Accrued Expenses and Other Current Liabilities
As of December 31, 2022 and 2021, accrued expenses and other current liabilities consisted of the following:
December 31,
2022
2021
Accrued consulting and professional services
$
320,000
$
250,000
Accrued leasehold improvements
92,528
—
Credit card payable
50,639
20,000
Accrued research and development expenses
35,524
436,840
Other
4,385
42,407
Accrued interest
—
94,792
Accrued franchise tax
—
1,680
Total accrued expenses and other current liabilities
$
503,076
$
845,719
Note 6 – Accrued Compensation
As of December 31, 2022 and 2021, accrued compensation consisted of the following:
December 31,
2022
2021
Accrued bonus expenses
$
1,447,643
$
1,245,795
Accrued payroll expenses
299,548
297,823
Total accrued compensation
$
1,747,191
$
1,543,618
F-16
Table of Contents
EYENOVIA, INC.
NOTES TO THE FINANCIAL STATEMENTS
FOR THE YEARS ENDED DECEMBER 31, 2022 AND 2021
Note 7 – Notes Payable and Convertible Notes Payable
As of December 31, 2022 and 2021, notes payable and convertible notes payable consisted of the following:
December 31, 2022
December 31, 2021
Notes Payable
Debt Discount
Net
Notes Payable
Debt Discount
Net
Silicon Valley Bank loan
$
—
$
—
$
—
$
7,500,000
$
( 349,632 )
$
7,150,368
Avenue - Note payable
5,212,500
( 847,114 )
4,365,386
—
—
—
Avenue - Convertible note payable
5,212,500
( 847,114 )
4,365,386
—
—
—
Total
10,425,000
( 1,694,228 )
8,730,772
7,500,000
( 349,632 )
7,150,368
Less: Current portion
Silicon Valley Bank loan
—
—
—
( 7,500,000 )
349,632
$
( 7,150,368 )
Avenue - Note payable
( 208,333 )
33,885
( 174,448 )
—
—
—
Avenue - Convertible note payable
( 208,333 )
33,885
( 174,448 )
—
—
—
Notes Payable, Non-Current
$
10,008,334
$
( 1,626,458 )
$
8,381,876
$
—
$
—
$
—
The non-current portion of notes payable and convertible notes payable includes a notes payable and a convertible note payable, each in the amount, net of discount, of $ 4,190,938 .
BankDirect Capital Finance Loan
On February 24, 2021, the Company issued a note payable for the purchase of a directors and officers’ liability insurance policy. The note payable was payable in nine monthly payments consisting of principal and interest amounting to $ 79,343 for an aggregate amount of $ 714,087 . The note accrued interest at a rate of 2.96 % per year and matured on November 24, 2021 .The note payable was repaid in full during the year ended December 31, 2021. Interest expense was $ 8,727 for the year ended December 31, 2021.
On February 24, 2022, the Company issued a note payable for the purchase of a directors and officers’ liability insurance policy. The note payable was payable in six monthly payments consisting of principal and interest amounting to $ 113,628 for an aggregate amount of $ 681,768 . The note accrued interest at a rate of 3.26 % per year and matured on August 24, 2022 . The note payable was repaid in full during the year ended December 31, 2022. Interest expense was $ 6,436 for the year ended December 31, 2022.
Paycheck Protection Program Loan
On May 8, 2020, the Company received cash proceeds of $ 463,353 pursuant to a loan provided in connection with the Paycheck Protection Program under the CARES Act, or the PPP Loan. The PPP Loan provided for monthly installment payments of $ 19,508 beginning in August 2021 with the remaining balance due on May 3, 2022, the original maturity date. The PPP Loan incurred interest at a fixed rate of 1.00 % per annum.
Under the terms of the CARES Act, as amended by the Paycheck Protection Program Flexibility Act of 2020, the Company was eligible to apply for and receive forgiveness for all or a portion of its PPP Loan. The Company applied for loan forgiveness on the PPP Loan in March 2021. The Company received notification in August 2021 that it had received approval for full loan forgiveness of the PPP Loan in the amount of $ 463,353 . The Company has recorded this extinguishment as other income in the statements of operations for the year ended December 31, 2021. The Company also received notification of forgiveness of accrued interest payable of $ 5,738 , which was reversed from interest expense.
Silicon Valley Bank Loan
On May 7, 2021, or the Effective Date, the Company entered into a Loan and Security Agreement, or the Loan, with Silicon Valley Bank, or SVB, for an aggregate principal amount of up to $ 25.0 million. The interest rate on the Loan was an annual rate equal to the greater of (a) the sum of 1.25% plus the prime rate as reported in The Wall Street Journal and (b) 5.00 %. The initial tranche of the Loan, in the amount of $ 7.5 million was received by the Company on May 7, 2021. The maturity date of the Loan was May 1, 2025 . The Loan
F-17
Table of Contents
EYENOVIA, INC.
NOTES TO THE FINANCIAL STATEMENTS
FOR THE YEARS ENDED DECEMBER 31, 2022 AND 2021
indicated a prepayment fee of 2.0 % of the principal balance made on or prior to the second anniversary of the Effective Date. The Loan also provided for a final payment in an amount equal to the original aggregate principal amount of the Loan multiplied by 5.0 %. The final payment is in addition to and not a substitution for the regular monthly payments of principal plus accrued interest and was due upon the repayment of the loan in full.
On September 29, 2021, the Company and SVB executed the First Amendment to the Loan and Security Agreement, or the Amendment. In accordance with the Amendment, the Company was required to maintain a collateralized money market account in the amount of $ 7,875,000 . The Company recorded this amount as restricted cash. On October 25, 2021, the Company announced the reclassification of Mydcombi as a drug-device combination product by the FDA in a CRL received on October 22, 2021. Given the FDA’s recent reclassification of Mydcombi as a drug-device combination and the need to file an NDA resubmission in 2022, the restricted cash became callable on November 30, 2021, at SVB’s election, to satisfy the Loan obligations. Therefore, the Loan was fully classified as a current note payable as of December 31, 2021.
In connection with the Loan, the Company issued warrants to SVB to purchase 91,884 shares of common stock at an exercise price per share equal to $ 4.76 . The warrants are exercisable for a period of ten years from the date of issuance. The Company determined that the warrants should be equity-classified and that the relative fair value was $ 354,539 , by using the Black-Scholes option pricing methodology using the following assumptions: stock price of $ 4.76 ; expected term of 10.0 years; volatility of 89.0 % and a risk-free interest rate of 1.60 %. The Company incurred $ 66,618 of debt issuance costs, of which $ 63,469 was allocated to the debt and $ 3,149 was allocated to the warrants. The relative fair value of the warrants and the issuance costs allocated to the debt were recorded as debt discount.
On November 4, 2022, the Company repaid the SVB Loan in full. The full amount of the payment was $ 8,025,000 , and included the principal amount of the loan ($ 7,500,000 ), the final payment ($ 375,000 ) and a 2 % prepayment fee ($ 150,000 ). The final payment and prepayment fee were recorded as interest expense. The entire restricted cash account in the amount of $ 7,875,000 was used to make the substantial amount of the payment.
During the years ended December 31, 2022 and 2021, the Company recorded interest expense relating to the Loan of $ 1,174,736 and $ 317,333 , respectively, including the amortization of debt discount of $ 349,632 and $ 68,376 , respectively.
Avenue Ventures Loan
On November 22, 2022, the Company entered into a Loan and Security Agreement, or the Avenue Loan, with Avenue Venture Opportunities Fund, L.P., or Avenue 1, and Avenue Venture Opportunities Fund, L.P. II, or Avenue 2, and together with Avenue, the Lender, for an aggregate principal amount of up to $ 15,000,000 . The initial tranche of the Avenue Loan is $ 10,000,000 , consisting of $ 4,000,000 from Avenue and $ 6,000,000 from Avenue 2. Up to $ 5,000,000 of the principal amount outstanding may be converted at the option of the Lender into shares of the Company’s common stock at a conversion price of $ 2.148 per share, subject to typical anti-dilution adjustments, or the Convertible Loan. The Avenue Loan bears interest at an annual rate equal to the greater of (A) 7.0 % and (B) the prime rate as reported in The Wall Street Journal plus 4.45 %. The Avenue Loan maturity date is November 1, 2025. The Company may request an additional $ 5,000,000 of gross funding between April 1, 2023 and July 31, 2023, subject to agreed-upon conditions. The Company must also make an incremental final payment equal to 4.25 % of the aggregate funding, or the Final Payment, amounting to a premium of $ 425,000 .
The Company will make monthly interest-only payments during the first twelve months of the Avenue Loan, which could be increased to up to eighteen months upon the achievement of specified performance milestones. Following the interest-only period, the Company will make equal monthly payments of principal and interest until the maturity date, plus interest. If the Company prepays the Avenue Loan, it will be required to pay a prepayment fee of 3 % if the Avenue Loan is prepaid during the first year, 2 % if the Avenue Loan is prepaid during the second year and 1 % if the Avenue Loan is repaid during the third year.
The Avenue Loan requires the Company to make and maintain representations and warranties and other agreements that are customary in loan agreements of this type. The Avenue Loan is secured by all of the Company’s assets globally, including intellectual property. The Avenue Loan also contains customary events of default, including non-payment of principal or interest, violations of covenants, bankruptcy and material judgments. Upon the occurrence of an event of default, all interest and principal will be accelerated and
F-18
Table of Contents
EYENOVIA, INC.
NOTES TO THE FINANCIAL STATEMENTS
FOR THE YEARS ENDED DECEMBER 31, 2022 AND 2021
immediately become due and payable. In addition, Avenue will have the right to exercise any other right or remedy provided by applicable law.
The Company paid a portfolio management fee of 1 % of the total commitment of $ 15,000,000 , or $ 150,000 of cash on December 1, 2022. This has been accounted for as a component of debt discount.
In connection with the Loan, the Company granted an aggregate of 547,807 shares of its common stock to the Lender, or the Avenue Private Placement Shares. Based on the Company’s stock price of $ 1.79 per share on the closing date, the shares have a gross value of $ 980,575 and a relative fair value of $ 859,734 . This is accounted for as a component of debt discount.
The following is a breakdown of the allocation of debt discount and origination costs:
Allocation of Debt Discount
Withheld
Eyenovia
Premium-
Equity
From
Origination
(Final
Equity
Total Debt
Issuance
Allocation %
Proceeds
Costs
Payment)
Issued
Discount
Costs
Non-Convertible Note
45.70
%
$
127,916
$
107,976
$
212,500
$
429,867
$
878,258
$
—
Convertible Note
45.70
%
127,916
107,976
212,500
429,867
878,258
—
Private Placement Shares
8.60
%
24,063
20,312
—
—
—
44,376
Total
100.00
%
$
279,895
$
236,264
$
425,000
$
859,734
$
1,756,516
$
44,376
Withheld From Closing Proceeds:
Broker Fee
$
250,000
Legal Reimbursement
29,895
Total
$
279,895
Eyenovia Origination Costs:
Legal Fee
$
86,264
Avenue Management Fee
150,000
Total
$
236,264
Total debt discount of $ 1,756,516 less the current year amortization of the Avenue loan in the amount of $ 62,288 resulted in unamortized debt discount of $ 1,694,228 at December 31, 2022.
The following is a summary of the Avenue loan:
December 31, 2022
Non-Convertible
Convertible
Total
Initial loan funding
$
5,000,000
$
5,000,000
$
10,000,000
Final payment
212,500
212,500
425,000
5,212,500
5,212,500
10,425,000
Less: Unamortized debt discount
( 847,114 )
( 847,114 )
( 1,694,228 )
4,365,386
4,365,386
8,730,772
Less: Current portion
( 174,448 )
( 174,448 )
( 348,896 )
Notes Payable, Non-Current
$
4,190,938
$
4,190,938
$
8,381,876
During the year ended December 31, 2022, the Company recorded interest expense relating to the Loan of $ 189,510 , including the amortization of debt discount of $ 62,288 .
F-19
Table of Contents
EYENOVIA, INC.
NOTES TO THE FINANCIAL STATEMENTS
FOR THE YEARS ENDED DECEMBER 31, 2022 AND 2021
Note 8 – Income Taxes
The provision for income taxes consists of the following expenses (benefits):
For The Years Ended
December 31,
2022
2021
Deferred tax provision (benefit):
Federal
5,879,362
( 1,248,043 )
State and local
( 208,806 )
( 2,358,623 )
5,670,556
( 3,606,666 )
Change in valuation allowance
( 5,670,556 )
3,606,666
Provision for income taxes
$
—
$
—
The provision for income taxes differs from the United States Federal statutory rate as follows:
For The Years Ended
December 31,
2022
2021
Federal statutory rate
( 21.0 )
%
( 21.0 )
%
State tax rate, net of federal benefit
( 2.5 )
%
( 7.3 )
%
Permanent differences
1.6
%
4.3
%
Research & development tax credits
( 1.0 )
%
( 0.6 )
%
Prior period adjustments and other
1.3
%
0.2
%
Rate and apportionment changes
1.3
%
( 3.8 )
%
Change in valuation allowance
20.3
%
28.2
%
Effective income tax rate
( 0.0 )
%
( 0.0 )
%
Deferred tax assets consist of the following:
For The Years Ended
December 31,
2022
2021
Deferred tax assets:
Net operating loss carryforwards
$
20,165,693
$
17,415,488
Research and development tax credits
799,182
605,919
Capitalized research and development costs
2,304,110
—
Stock-based compensation
2,089,014
2,070,759
Intangible assets
633,151
531,454
Lease liability
327,276
—
Total gross deferred tax assets
26,318,426
20,623,620
Deferred tax liabilities
Property and equipment
( 184,138 )
( 463,442 )
Right ot use asset
( 303,554 )
—
Deferred tax assets, net before allowance
25,830,734
20,160,178
Valuation allowance
( 25,830,734 )
( 20,160,178 )
Deferred tax assets, net
$
—
$
—
Changes in valuation allowance
$
( 5,670,556 )
$
3,606,666
F-20
Table of Contents
EYENOVIA, INC.
NOTES TO THE FINANCIAL STATEMENTS
FOR THE YEARS ENDED DECEMBER 31, 2022 AND 2021
As of December 31, 2022, the Company had approximately $ 85,900,000 of domestic federal net operating loss carryforwards, or NOLs, that may be available to offset future federal taxable income. Approximately $ 10,800,000 of those NOLs will expire during the years ranging from 2034 to 2037 . The remaining NOLs of approximately $ 75,100,000 have no expiration dates. Internal Revenue Code Section 382 limits the utilization of approximately $ 35,000,000 of those NOLs to approximately $ 918,000 on an annual basis as a result of ownership changes that occurred through July 15, 2019. As of December 31, 2022, the Company had approximately $ 25,400,000 of state NOLs, of which approximately $ 25,300,000 will expire during the years ranging from 2040 to 2042 , and approximately $ 100,000 will not expire, and had approximately $ 6,400,000 of local NOLs which do not expire.
The Company has assessed the likelihood that deferred tax assets will be realized in accordance with the provisions of ASC 740 “Income Taxes Accounting”, or ASC 740. ASC 740 requires that a valuation allowance be established when it is “more likely than not” that all, or a portion of, deferred tax assets will not be realized. The assessment considers all available positive or negative evidence, including the scheduled reversal of deferred tax liabilities, projected future taxable income, and tax planning strategies. After the performance of such reviews as of December 31, 2022 and 2021, management believes that uncertainty exists with respect to future realization of its deferred tax assets and has, therefore, established a full valuation allowance as of those dates.
Management has evaluated and concluded that there were no material uncertain tax positions requiring recognition in the Company’s financial statements as of December 31, 2022 and 2021. The Company does not expect any significant changes in its unrecognized tax benefits within twelve months of the reporting date.
No tax audits were commenced or were in process during the years ended December 31, 2022 and 2021. No tax related interest or penalties were incurred during the years ended December 31, 2022 and 2021. The Company’s federal, state and local income tax returns beginning with the year ended December 31, 2019 remain subject to examination.
Note 9 – Commitments and Contingencies
Employment Agreements
On February 14, 2022, the Compensation Committee of the Board approved amendments to the Executive Employment Agreements, or the Employment Agreement Addendums, for three executive officers. Each of the Employment Agreement Addendums provides that if the executive’s employment is terminated by the Company without “Cause” or the executive suffers an “Involuntarily Termination” (each as defined in the employment agreements), provided that the executive has signed a full release of all claims, the executive will be entitled to receive: (i) severance pay equal to twelve months of his or her then-current base salary, and (ii) a reimbursement for health insurance benefits under COBRA for the executive and his or her spouse and dependents for a period of twelve months or until the executive becomes eligible for comparable insurance benefits from another employer, whichever is earlier.
Transition of Chief Executive Officer
On July 27, 2022, the Company announced the appointment of Michael Rowe as its new Chief Executive Officer, or CEO, effective August 1, 2022, with Dr. Tsontcho Ianchulev (the former CEO) becoming Executive Chairman of the Board. Mr. Rowe is also serving as a member of the Board.
On July 26, 2022, the Company entered into an Employment Agreement, or the Employment Agreement, with Mr. Rowe under which he will serve as Chief Executive Officer of the Company. Under the terms of the Employment Agreement, Mr. Rowe will receive an annual salary of $ 575,000 . He is eligible to receive a cash bonus of up to 60 % of his base salary. Additionally, Mr. Rowe received an option to purchase 440,000 shares of the Company’s common stock, exercisable at $ 1.66 per share, pursuant to the Company’s Amended and Restated 2018 Omnibus Stock Incentive Plan, as amended. Mr. Rowe will also continue to participate in any and all benefit plans, from time to time, in effect for senior management, along with vacation, sick and holiday pay in accordance with the Company’s policies established and in effect from time to time. As a result of the change of salary, the aggregate potential severance pay for the executive officers of the Company is approximately $ 1,004,000 .
The Company also entered into an agreement with Dr. Ianchulev, or the Executive Chairman Agreement, pursuant to which Dr. Ianchulev will provide medical expertise and consultation related to the Company’s research and development programs, and such other matters as reasonably requested by the Company for an initial period of one year . In consideration for Dr. Ianchulev’s services, the
F-21
Table of Contents
EYENOVIA, INC.
NOTES TO THE FINANCIAL STATEMENTS
FOR THE YEARS ENDED DECEMBER 31, 2022 AND 2021
Company has agreed to provide Dr. Ianchulev with a $ 5,000 monthly retainer throughout the term of the agreement, in addition to the compensation payable to all non-employee members of the Board.
Operating Leases
On August 8, 2018, the Company entered into a lease agreement to lease approximately 3,800 square feet of office space in New York, NY. The monthly base rent ranges from $ 19,633 to $ 22,486 per month over the term of the lease. The lease expires on September 30, 2023 . The security deposit is approximately $ 118,000 , which has been classified as a current asset. The Company’s rent expense for this space is recorded in general and administrative expense and amounted to $ 242,067 for each of the years ended December 31, 2022 and 2021, respectively.
On January 20, 2020, the Company entered into a lease agreement to lease 660 square feet of office space in Laguna Hills, California. The lease term was one year and the lease was renewed each year until it expired on April 30, 2022 . The monthly base rent ranged from $ 1,254 to $ 1,292 per month over the term of the lease. The Company received its $ 1,254 security deposit after the lease expired. The Company had also agreed to lease the adjoining premises as part of the lease extension. The additional office space is also 660 square feet. The lease term for this space expires April 30, 2023 . The monthly rent ranges from $ 1,750 to $ 1,838 per month. The security deposit is $ 1,750 and has been classified as a current asset. The Company’s rent expense for the space in this location is recorded in general and administrative expense and amounted to $ 20,501 and $ 29,424 for the years ended December 31, 2022 and 2021, respectively.
On April 8, 2022, the Company entered into a new lease agreement for 3,916 square feet in Laguna Hills, California. The new lease term is five years and two months , commencing on June 1, 2022 and expiring on July 31, 2027 . The monthly base rent ranges from $ 9,203 to $ 10,358 per month over the term of the lease. The security deposit is $ 11,400 . The Company’s rent expense for all Laguna Hills space is recorded in general and administrative expense and amounted to $ 66,196 and $ 0 for the years ended December 31, 2022 and 2021, respectively.
On July 17, 2020, the Company entered into a lease agreement to lease approximately 3,000 square feet of office space in Redwood City, California, or the Gross Industrial Lease. The monthly base rent was for $ 7,500 per month over the term of the lease through August 31, 2021 with a security deposit of $ 7,500 . On December 1, 2020, the Company agreed to amend the terms of the Gross Industrial Lease for a base rent that ranges from $ 7,500 to $ 7,957 per month over the term of the lease. The amended Gross Industrial Lease expires on August 31, 2023 . Concurrent with the amendment to the Gross Industrial Lease on December 1, 2020, the Company entered into a lease agreement to lease approximately 1,500 square feet of additional office space in Redwood City, California. The monthly base rent ranges from $ 3,000 to $ 3,183 per month over the term of the lease. The lease expires on August 31, 2023 . The security deposit is $ 3,000 . Also concurrent with the amendment to the Gross Industrial Lease on December 1, 2020, the Company entered into an additional lease agreement to lease 2,169 square feet of additional office space in Redwood City, California. The monthly base rent ranges from $ 4,468 to $ 4,602 per month over the term of the lease. The lease commenced on January 1, 2022 and expires on August 31, 2023. The security deposit is $ 4,468 . The Company's rent expense for all Redwood City space is recorded in research and development expense and amounted to $ 180,240 and $ 128,560 for the years ended December 31, 2022 and 2021, respectively.
The Company leases 953 square feet of office space in Reno, NV for research and development activities from a company owned by the Company’s former Vice President of Research and Development. The lease, as amended in September 2022, expires on May 1, 2023 and provides for lease payments of $ 5,675 per month and a security deposit in the amount of $ 5,675 . Since the inception of the lease, the Company made $ 112,600 of leasehold improvements related to this lease which are included in property and equipment, net on the accompanying balance sheets. The Company’s rent expense for this space is recorded in research and development expense and amounted to $ 68,498 and $ 64,848 for the years ended December 31, 2022 and 2021, respectively.
On May 19, 2022, the Company entered into a lease agreement to lease 10,880 square feet of office space in Reno, Nevada. The lease term is five years and four months , commencing on May 23, 2022 and expiring on September 23, 2027 . The monthly base rent ranges from $ 13,056 to $ 16,663 per month over the term of the lease. The security deposit is $ 53,000 . The Company’s rent expense for this space is recorded in research and development expense and amounted to $ 101,023 for the year ended December 31, 2022.
F-22
Table of Contents
EYENOVIA, INC.
NOTES TO THE FINANCIAL STATEMENTS
FOR THE YEARS ENDED DECEMBER 31, 2022 AND 2021
A summary of the Company’s right-of-use assets and liabilities is as follows:
For the Year Ended
December 31, 2022
Cash paid for amounts included in the measurement of lease liabilities:
Operating cash flows used in operating activities
$
412,478
Right-of-use assets obtained in exchange for lease obligations
Operating leases
$
1,186,098
Weighted Average Remaining Lease Term (Years)
Operating leases
3.71 years
Weighted Average Discount Rate
Operating leases
10.0
%
Future minimum payments under the Company’s operating lease agreements are as follows:
For the Year Ending
December 31,
Minimum Lease Payments
2023
$
588,181
2024
278,254
2025
289,887
2026
302,039
2027
216,126
Total lease payments
1,674,487
Less: Imputed interest
( 281,961 )
Present value of lease liabilities
1,392,526
Less: current portion
( 484,882 )
Lease liabilities, non-current portion
$
907,644
Litigations, Claims and Assessments
In the normal course of business, the Company may be involved in legal proceedings, claims and assessments arising in the ordinary course of business. The Company records legal costs associated with loss contingencies as incurred and accrues for all probable and estimable settlements.
Note 10 – Related Party Transactions
See Note 9 - Commitments and Contingencies for certain commitments and contingencies entered into with certain related parties.
Senju License Agreement
During 2015, the Company entered into an exclusive license agreement with Senju, or the Senju License Agreement, whereby the Company agreed to grant to Senju an exclusive, royalty-bearing license for its microdose product candidates for Asia to sublicense, develop, make, have made, manufacture, use, import, market, sell, and otherwise distribute the microdose product candidates. In consideration for the license, Senju agreed to pay to Eyenovia five percent ( 5 %) royalties on sales (net of certain manufacturing costs) for the term of the Senju License Agreement, subject to certain adjustments upon the loss of patent coverage for the term of the license agreement. The agreement will continue in full force and effect, on a country-by-country basis, until the latest to occur of: (i) the tenth (10th) anniversary of the first commercial sale of such a product candidate in a country; or (ii) the expiration of the licensed patents in a country. As of the date of this filing, there have been no commercial sales of such a product in Asia; therefore, no royalties have been earned. Senju is owned by the family of a former member of the Company’s Board of Directors.
F-23
Table of Contents
EYENOVIA, INC.
NOTES TO THE FINANCIAL STATEMENTS
FOR THE YEARS ENDED DECEMBER 31, 2022 AND 2021
On April 8, 2020, Eyenovia entered into an amendment, or the Senju License Amendment, to the Senju License Agreement. Pursuant to the Senju License Amendment, the Company can license to any third party the right to research, develop, commercialize, manufacture or use certain products, or the Senju Licensed Products previously licensed to Senju in China (including the People’s Republic of China, Hong Kong, Macao, and Taiwan) and South Korea, or the Territory.
Pursuant to the Senju License Amendment, the Company must pay Senju (a) a percentage in the range of 30 % to 40 % of revenue on (i) any lump-sum payments the Company receives from the third party, (ii) revenue (net of costs) obtained by the Company from contract research and/or development of the Senju Licensed Product in the Territory, and (iii) revenue (net of costs) obtained by the Company from contract manufacture for the device of the Senju Licensed Product in the Territory, the aggregate of which must be at least a $ 9 million minimum payment to Senju; and (b) a percentage in the range of 30 % to 40 % of any sales royalty revenue the Company receives from the third party. Since the Company executed a third-party license prior to the April 8, 2021 expiration of the Senju License, the Senju License Amendment will remain in effect for the duration of the license, subject to early termination.
The Senju License Agreement was further amended in a Letter Agreement by and between the Company and Senju on August 10, 2020, or the Letter Agreement. Pursuant to the Letter Agreement, the Company will pay to Senju a percentage in the range of 30 % to 40 % of certain payments, royalties, or net proceeds received from Arctic Vision in connection with the Arctic Vision License Agreement. The Senju License Agreement was amended further by the License Amendment 2, effective September 14, 2021, or the Amendment 2. The Amendment 2 excludes Greater China and South Korea from the territory in which Senju was granted an exclusive royalty-bearing license from the Company. In consideration for this exclusion, and upon and after the execution of Amendment 1 with Arctic Vision, the Company must make payments to Senju based on non-royalty license revenue and sales revenue, including the following:
1. a one-time upfront payment of $ 250,000 , paid on September 17, 2021, which represented an inducement to Senju to approve Amendment 1 of the Arctic Vision License Agreement related to the MicroStat product.
2. a percentage in the range from 30 % to 40 % of any upfront or milestone lump sum payments, or net revenues received by the Company in connection with any licensed product using piezo-print technology in a microdose dispenser containing: (a) the chemical substance atropine sulfate as its sole active ingredient and that is used for the treatment of myopia in humans; (b) the chemical substance pilocarpine as its sole active ingredient and that is used for the treatment of presbyopia in humans; or (c) the chemical substances phenylephrine and tropicamide in combination as active ingredients that are used for pharmaceutical mydriasis in humans (the “LA2 Licensed Product”) from certain third parties, and
3. a percentage in the range from thirty to forty percent of the amounts received by the Company in connection with sales of the LA2 Licensed Product in China and South Korea by certain third parties.
See Note 2 – Summary of Significant Accounting Policies – Revenue Recognition - Arctic Vision License Agreement for additional details regarding the Arctic Vision License Agreement.
Note 11 – Stockholders’ Equity
Authorized Capital
The Company is authorized to issue 90,000,000 shares of common stock, par value of $ 0.0001 per share, and 6,000,000 shares of preferred stock, par value of $ 0.0001 per share. The holders of the Company’s common stock are entitled to one vote per share. The Board of Directors is empowered, without stockholder approval, to issue preferred stock with dividend, liquidation, redemption, voting or other rights.
Equity Incentive Plans
On April 7, 2020, the Company’s Board of Directors approved the Company’s Amended and Restated 2018 Omnibus Stock Incentive Plan (the “Restated Plan”), which stockholders approved on June 30, 2020. Under the Restated Plan, as amended on June 16, 2022, 5,700,000 shares of the Company’s common stock are reserved for issuance. The Restated Plan requires that all equity awards issued under the Restated Plan vest at least twelve months from the applicable grant date, subject to accelerated vesting, and provides that no dividend or dividend equivalent will be paid on any unvested equity award, although dividends with respect to unvested portions of equity may accrue and be paid when, and if, the awards later vest and the shares are actually issued to the grantee. In addition, the Restated Plan sets an annual limit on the grant date fair value of awards to any non-employee director, together with any cash fees paid
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EYENOVIA, INC.
NOTES TO THE FINANCIAL STATEMENTS
FOR THE YEARS ENDED DECEMBER 31, 2022 AND 2021
during the year, of $ 150,000 , subject to certain exceptions for a non-executive chair of the Board. As of December 31, 2022, the number of securities remaining available for future issuance under equity compensation plans was 1,011,245 .
At-The-Market Offering
May 2021 Sales Agreement
On May 14, 2021, the Company entered into a Sales Agreement, or the May 2021 Sales Agreement with SVB Securities LLC, or SVB Securities (formerly known as SVB Leerink LLC), under which the Company was able to offer and sell, from time to time at its sole discretion, shares of its common stock having an aggregate offering price of up to $ 30 million through SVB Securities as its sales agent. Subject to the terms and conditions of the May 2021 Sales Agreement, SVB Securities was able to sell the common stock by any method permitted by law deemed to be an “at-the-market offering” as defined in Rule 415(a)(4) of the Securities Act of 1933, as amended. SVB Securities was obligated to use commercially reasonable efforts to sell the common stock from time to time, based upon instructions from the Company (including any price, time or size limits or other customary parameters or conditions the Company may impose). The Company had to pay SVB Securities a commission equal to three percent ( 3.0 )% of the gross sales proceeds of any common stock sold through SVB Securities under the May 2021 Sales Agreement.
Pursuant to the May 2021 Sales Agreement, the Company commenced sales of its common stock on October 6, 2021. During the year ended December 31, 2021, the Company received approximately $ 12.8 million in gross proceeds and $ 12.4 million in net proceeds from the sale of 2,435,604 shares of its common stock under the May 2021 Sales Agreement.
December 2021 Sales Agreement
On December 14, 2021, the Company entered into a Sales Agreement, or the December 2021 Sales Agreement, with SVB Securities under which the Company may offer and sell, from time to time at its sole discretion, shares of common stock for gross proceeds of up to $ 50.0 million through SVB Securities as its sales agent, or the Offering. The May 2021 Sales Agreement was terminated upon the effectiveness of the December 2021 Sales Agreement. The issuance and sale of shares, if any, of common stock by the Company under the December 2021 Sales Agreement will be pursuant to the Company’s Registration Statement on Form S-3 (File No. 333-261638) filed with the SEC on December 14, 2021, or the Registration Statement, and the prospectus relating to the Offering filed therewith that forms a part of the Registration Statement.
Subject to the terms and conditions of the December 2021 Sales Agreement, SVB Securities may sell the common stock by any method permitted by law deemed to be an “at the market offering” as defined in Rule 415(a)(4) of the Securities Act of 1933, as amended. SVB Securities will use commercially reasonable efforts to sell the common stock from time to time, based upon instructions from the Company (including any price, time or size limits or other customary parameters or conditions the Company may impose). The Company will pay SVB Securities a commission equal to three percent ( 3.0 )% of the gross sales proceeds of any common stock sold through SVB Securities under the December 2021 Sales Agreement, and also has provided SVB Securities with certain indemnification rights. During the year ended December 31, 2022, the Company received approximately $ 5.4 million in gross proceeds and $ 5.3 million in net proceeds from the sale of 2,716,061 shares of its common stock under the December 2021 Sales Agreement.
Securities Purchase Agreement
On March 3, 2022, the Company entered into a securities purchase agreement, or the Purchase Agreement with a certain institutional and accredited investor, or the Purchaser, pursuant to which the Company issued (i) 3,000,000 shares of common stock, (ii) pre-funded warrants, or the Pre-Funded Warrants, to purchase an aggregate of 1,870,130 shares of common stock and (iii) warrants to purchase an aggregate of 4,870,130 shares of common stock, or the Investor Warrants, or the March 2022 Offering. The Company determined that the warrants qualified for equity classification.
The offering price for the shares was $ 3.08 per share and the offering price for the Pre-Funded Warrants was $ 3.07 per Pre-Funded Warrant, which represents the per share public offering price less $ 0.01 per share exercise price for each Pre-Funded Warrant. The Investor Warrants will have an exercise price of $ 3.54 per share and each Investor Warrant will be exercisable for one share of Common Stock. The Investor Warrants will be exercisable beginning six months from the date of issuance and the Pre-Funded Warrants will be exercisable immediately upon issuance. The Pre-Funded Warrants shall terminate when fully exercised and the Investor Warrants will
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EYENOVIA, INC.
NOTES TO THE FINANCIAL STATEMENTS
FOR THE YEARS ENDED DECEMBER 31, 2022 AND 2021
terminate five years from the initial exercisability date. The aggregate gross proceeds to the Company from the March 2022 Offering were approximately $ 15 million, excluding the proceeds, if any, from the exercise of the Pre-Funded Warrants and the Investor Warrants. No underwriter or placement agent participated in the March 2022 Offering. The Company incurred issuance costs in the amount of $ 89,031 in connection with the March 2022 offering.
The March 2022 Offering was made pursuant to an effective registration statement on Form S-3 (Registration Statement No. 333-261638), as previously filed with and declared effective by the Securities and Exchange Commission and a related prospectus.
Warrants
A summary of the warrant activity during the year ended December 31, 2022 is presented below:
Weighted
Weighted
Average
Average
Remaining
Aggregate
Number of
Exercise
Life
Intrinsic
Warrants
Price
In Years
Value
Outstanding January 1, 2022
1,217,715
$
2.69
Granted
6,740,260
2.56
Exercised
( 1,870,130 )
0.01
Outstanding December 31, 2022
6,087,845
$
3.37
4.3
$
—
Exercisable December 31, 2022
6,087,845
$
3.37
4.3
$
—
The following table presents information related to warrants as of December 31, 2022:
Warrants Outstanding
Warants Exercisable
Weighted
Outstanding
Average
Exercisable
Exercise
Number of
Remaining Life
Number of
Price
Warrants
In Years
Warrants
$ 2.4696
909,451
2.2
909,451
$ 2.7240
216,380
2.2
216,380
$ 4.7600
91,884
8.3
91,884
$ 3.5400
4,870,130
4.7
4,870,130
6,087,845
4.3
6,087,845
During the year ended December 31, 2022, warrants for the purchase of 1,870,130 shares of the Company’s common stock with an exercise price $ 0.01 per share were exercised for aggregate proceeds of $ 18,701 .
Stock-Based Compensation Expense
The Company records stock-based compensation expense related to stock options and restricted stock units, or RSUs. For the years ended December 31, 2022 and 2021, the Company recorded stock-based compensation expense of $ 3,765,364 ($ 1,809,305 of which was included within research and development expenses and $ 1,956,059 was included within general and administrative expenses on the statements of operations) and $ 2,886,102 ($ 1,612,942 of which was included within research and development expenses and $ 1,273,160 was included within general and administrative expenses on the statements of operations), respectively.
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Table of Contents
EYENOVIA, INC.
NOTES TO THE FINANCIAL STATEMENTS
FOR THE YEARS ENDED DECEMBER 31, 2022 AND 2021
Restricted Stock Units
A summary of the restricted stock units activity during the year ended December 31, 2022 is presented below:
Number of
Exercise
RSUs
Price
RSUs non-vested January 1, 2022
41,778
$
3.59
Granted
193,304
1.93
Vested
( 55,319 )
3.37
Forfeited
( 6,963 )
3.59
RSUs non-vested December 31, 2022
172,800
$
1.80
Vested RSUs undelivered December 31, 2022
32,900
$
3.59
To date, the RSUs have only been granted to directors in accordance with the Company’s Amended and Restated 2018 Omnibus Stock Incentive Plan. The Company’s policy is not to deliver shares underlying the RSUs until the termination of service.
Between March 31, 2021 and November 17, 2021 the Company granted members of its Board of Directors an aggregate of 49,964 RSUs under the Restated Plan. Each RSU is subject to settlement into one share of the Company’s common stock. The RSUs vest on the earlier of (i) the one-year anniversary of the date of grant and (ii) June 16, 2022 (the date of the 2022 annual stockholders meeting), subject to the grantee remaining on the Board until then. The RSUs had a grant date fair value of $ 181,200 , which will be recognized over the vesting period.
Between February 14, 2022 and August 18, 2022 the Company granted members of its Board of Directors an aggregate of 193,304 RSUs under the Restated Plan. Each RSU is subject to settlement into one share of the Company’s common stock. The RSUs vest on the earlier of (i) the one-year anniversary of the date of grant and (ii) the date of the 2023 annual stockholders meeting, subject to the grantee remaining on the Board until then. The RSUs had a grant date fair value of $ 373,000 , which will be recognized over the vesting period.
As of December 31, 2022, there was $ 149,158 of unrecognized stock-based compensation expense related to RSUs which will be recognized over a weighted average period of 0.5 years.
Stock Options
A summary of the option activity during the year ended December 31, 2022 is presented below:
Weighted
Weighted
Average
Average
Remaining
Aggregate
Number of
Exercise
Life
Intrinsic
Options
Price
In Years
Value
Outstanding, January 1, 2022
4,377,398
$
3.89
Granted
1,181,310
2.23
Exercised
—
—
Forfeited
( 178,155 )
3.01
Outstanding, December 31, 2022
5,380,553
$
3.55
7.2
$
85,800
Exercisable, December 31, 2022
3,614,195
$
3.79
6.4
$
85,800
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EYENOVIA, INC.
NOTES TO THE FINANCIAL STATEMENTS
FOR THE YEARS ENDED DECEMBER 31, 2022 AND 2021
The following table presents information related to stock options as of December 31, 2022:
Options Outstanding
Options Exercisable
Weighted
Outstanding
Average
Exercisable
Exercise
Number of
Remaining Life
Number of
Price
Options
In Years
Options
$ 1.00 - $ 1.99
1,517,952
3.8
754,302
$ 2.00 - $ 2.99
1,010,018
7.4
847,485
$ 3.00 - $ 3.99
1,202,539
6.8
804,840
$ 4.00 - $ 4.99
383,500
8.5
193,623
$ 5.00 - $ 5.99
100,805
6.0
83,972
$ 6.00 - $ 6.99
1,000,821
7.0
765,055
$ 7.00 +
164,918
5.3
164,918
5,380,553
6.4
3,614,195
In applying the Black-Scholes option pricing model to stock options granted, the Company used the following approximate assumptions:
For the Year Ended
December 31,
2022
2021
Expected term (years)
0.58 - 10.00
5.85 - 10.00
Risk free interest rate
0.76 % - 3.80 %
0.45 % - 1.58 %
Expected volatility
82 % - 90 %
92 % - 94 %
Expected dividends
0.00 %
0.00 %
The Company has computed the fair value of stock options granted using the Black-Scholes option pricing model. Option forfeitures are accounted for at the time of occurrence. The expected term used for options issued is the estimated period of time that options granted are expected to be outstanding. The Company utilizes the “simplified” method to develop an estimate of the expected term of “plain vanilla” option grants. The Company uses a blended volatility calculation, the components of which are the Company’s historical volatility for the period from its initial public offering through the valuation date and the average peer-group data of six comparable entities to supplement the Company’s own historical data for the preceding years in computing the expected volatility. Accordingly, the Company is utilizing an expected volatility figure based on a review of the historical volatility of comparable entities over a period of time equivalent to the expected life of the instrument being valued. The risk-free interest rate was determined from the implied yields from U.S. Treasury zero-coupon bonds with a remaining term consistent with the expected term of the instrument being valued. The Company has not declared dividends, is currently in the development stage and has no plan to declare future dividends at this time.
The weighted average estimated grant date fair value of the stock options granted for the years ended December 31, 2022 and 2021 was approximately $ 1.60 and $ 5.39 per share, respectively.
As of December 31, 2022, there was $ 3,621,440 of unrecognized stock-based compensation expense related to stock options which will be recognized over a weighted average period of 1.5 years.
Note 12 – Employee Benefit Plans
401(k) Plan
In April 2019, the Company adopted the Eyenovia 401(k) Plan, or the Plan, which went into effect in May 2019. All Company employees are able to participate in the Plan, subject to eligibility requirements as outlined in the Plan documents. Under the terms of the Plan, eligible employees are able to defer a percentage of their pay every pay period up to annual limitations set by Congress and the Internal Revenue Service under Section 401(k) of the Internal Revenue Code. For 2019, the Company’s Board of Directors has approved a matching contribution equal to 100 % of elective deferrals up to 4 % of eligible earnings with the matching contribution subject to certain
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EYENOVIA, INC.
NOTES TO THE FINANCIAL STATEMENTS
FOR THE YEARS ENDED DECEMBER 31, 2022 AND 2021
vesting requirements as outlined in the Plan documents. For the years ended December 31, 2022 and 2021, the Company recorded expense of $ 208,006 and $ 175,352 associated with its matching contributions, respectively.
Note 13 – Subsequent Events
Stock Option Grants
Subsequent to December 31, 2022, the Company issued ten-year stock options to certain employees and consultants to purchase an aggregate of 421,735 shares of common stock of the Company at an exercise price $ 2.16 per share. The options vest as follows: (i) one-third of the shares vest on the one-year anniversary of the issuance date; and (ii) the remaining two-thirds vest in equal installments beginning 13 months from the issuance date and ending 36 months from the issuance date. The fair value of the options will be recognized over the vesting period.
December 2021 Sales Agreement
Subsequent to December 31, 2022, the Company received approximately $ 3.5 million of net proceeds from the sale of 1,299,947 shares of its common stock pursuant to the December 2021 Sales Agreement with SVB Securities.
Development Collaboration Agreement With Formosa
On February 15, 2023, the Company announced that they had entered into a Development Collaboration Agreement, or the Agreement with Formosa Pharmaceuticals, Inc., or Formosa, a Taiwan-based company. The Agreement combines the Company’s Optejet dispensing technology with Formosa’s unique APNT nanoparticle formulation platform for the potential development of new topical ophthalmic therapeutics that employ the Optejet dispenser. In 2023, the Company will conduct feasibility testing of novel APNT formulations in the Optejet and request a pre-IND meeting with the FDA. Formosa will develop and optimize new APNT formulations for use in Optejet and deliver to the Company for device qualification and validation.
Appointment of Chief Operating Officer
Effective January 1, 2023, the Company appointed Bren Kern, the Company’s Senior Vice President of Manufacturing and Operations, as the Company’s Chief Operating Officer. The Company entered into an Employment Agreement with Mr. Kern, under which Mr. Kern receives an annual salary of $ 345,000 . He is eligible to receive a cash bonus of up to 30 % of his base salary. Additionally, Mr. Kern received an option to purchase 120,000 shares of its common stock.
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