Item 1. Financial Statements
Item 1. Financial Statements.
EYENOVIA, INC.
Condensed Balance Sheets
September 30,
December 31,
2023
2022
(unaudited)
Assets
Current Assets
Cash and cash equivalents
$
20,702,212
$
22,863,520
Inventories
50,296
—
Deferred clinical supply costs
3,622,687
2,284,931
License fee and expense reimbursements receivable
397,014
1,183,786
Security deposits, current
—
119,550
Prepaid expenses and other current assets
1,760,824
1,190,719
Total Current Assets
26,533,033
27,642,506
Property and equipment, net
3,531,365
1,295,115
Security deposits, non-current
198,674
80,874
Intangible assets
2,122,945
—
Operating lease right-of-use asset
1,792,667
1,291,592
Equipment deposits
686,753
726,326
Total Assets
$
34,865,437
$
31,036,413
Liabilities and Stockholders’ Equity
Current Liabilities:
Accounts payable
$
1,426,028
$
1,428,283
Accrued compensation
1,375,832
1,747,191
Accrued expenses and other current liabilities
295,703
503,076
Operating lease liabilities - current portion
444,616
484,882
Notes payable - current portion, net of debt discount of $ 327,217 and $ 33,885 as of September 30, 2023 and December 31, 2022, respectively
3,006,116
174,448
Convertible notes payable - current portion, net of debt discount of $ 0 and $ 33,885 as of September 30, 2023 and December 31, 2022, respectively
—
174,448
Total Current Liabilities
6,548,295
4,512,328
Operating lease liabilities - non-current portion
1,441,081
907,644
Notes payable - non-current portion, net of debt discount of $ 754,919 and $ 813,229 as of September 30, 2023 and December 31, 2022, respectively
6,549,248
4,190,938
Convertible notes payable - non-current portion, net of debt discount of $ 452,920 and $ 813,229 as of September 30, 2023 and December 31, 2022, respectively
4,547,080
4,190,938
Total Liabilities
19,085,704
13,801,848
Commitments and contingencies (Note 8)
Stockholders’ Equity:
Preferred stock, $ 0.0001 par value, 6,000,000 shares authorized; 0 shares issued and outstanding as of September 30, 2023 and December 31, 2022
—
—
Common stock, $ 0.0001 par value, 90,000,000 shares authorized; 42,898,246 and 36,668,980 shares issued and outstanding as of September 30, 2023 and December 31, 2022, respectively
4,290
3,667
Additional paid-in capital
153,299,865
135,461,361
Accumulated deficit
( 137,524,422 )
( 118,230,463 )
Total Stockholders’ Equity
15,779,733
17,234,565
Total Liabilities and Stockholders’ Equity
$
34,865,437
$
31,036,413
The accompanying notes are an integral part of these condensed financial statements.
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EYENOVIA, INC.
Condensed Statements of Operations
(unaudited)
For the Three Months Ended
For the Nine Months Ended
September 30,
September 30,
2023
2022
2023
2022
Operating Income
Revenue
$
1,198
$
—
$
1,198
$
—
Cost of revenue
( 1,198 )
—
( 1,198 )
—
Gross Profit
—
—
—
—
Operating Expenses:
Research and development
3,578,113
3,876,876
8,911,124
11,176,326
General and administrative
2,942,073
3,353,352
9,028,768
10,362,907
Total Operating Expenses
6,520,186
7,230,228
17,939,892
21,539,233
Loss From Operations
( 6,520,186 )
( 7,230,228 )
( 17,939,892 )
( 21,539,233 )
Other Income (Expense):
Other (expense) income, net
( 348,226 )
70,277
( 157,783 )
96,580
Interest expense
( 679,222 )
( 177,138 )
( 1,691,228 )
( 475,811 )
Interest income
208,901
28,093
494,944
30,703
Total Other Expense
( 818,547 )
( 78,768 )
( 1,354,067 )
( 348,528 )
Net Loss
$
( 7,338,733 )
$
( 7,308,996 )
$
( 19,293,959 )
$
( 21,887,761 )
Net Loss Per Share - Basic and Diluted
$
( 0.18 )
$
( 0.21 )
$
( 0.50 )
$
( 0.67 )
Shares Outstanding - Basic and Diluted
40,139,697
34,631,774
38,563,074
32,778,551
The accompanying notes are an integral part of these condensed financial statements.
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EYENOVIA, INC.
Condensed Statements of Changes in Stockholders’ Equity
(unaudited)
For the Three and Nine Months Ended September 30, 2023
Additional
Total
Common Stock
Paid-In
Accumulated
Stockholders’
Shares
Amount
Capital
Deficit
Equity
Balance - January 1, 2023
36,668,980
$
3,667
$
135,461,361
$
( 118,230,463 )
$
17,234,565
Issuance of common stock in At the Market offering [1]
1,299,947
130
3,499,462
—
3,499,592
Cashless exercise of stock options
19,530
2
( 2 )
—
—
Stock-based compensation
—
—
819,064
—
819,064
Issuance of common stock related to vested restricted stock units
3,289
—
—
—
—
Net loss
—
—
—
( 5,739,366 )
( 5,739,366 )
Balance - March 31, 2023
37,991,746
3,799
139,779,885
( 123,969,829 )
15,813,855
Issuance of common stock in At the Market offering [2]
121,989
13
403,107
—
403,120
Cashless exercise of stock options
1,219
—
—
—
—
Exercise of stock options
10,000
1
27,199
—
27,200
Stock-based compensation
—
—
493,632
—
493,632
Issuance of common stock related to vested restricted stock units
44,444
4
( 4 )
—
—
Net loss
—
—
—
( 6,215,860 )
( 6,215,860 )
Balance - June 30, 2023
38,169,398
3,817
140,703,819
( 130,185,689 )
10,521,947
Issuance of common stock and warrants in registered direct offering [3][7]
4,198,633
420
10,885,694
—
10,886,114
Issuance of common stock as consideration for licensing agreement [4]
487,805
49
999,951
—
1,000,000
Issuance of common stock in At the Market offering [5]
42,410
4
97,432
—
97,436
Warrant modification - incremental value (6)
—
—
1,738,700
—
1,738,700
Warrant modification - in issuance costs for registered direct offering (7)
—
—
( 1,738,700 )
—
( 1,738,700 )
Stock-based compensation
—
—
612,969
—
612,969
Net loss
—
—
—
( 7,338,733 )
( 7,338,733 )
Balance - September 30, 2023
42,898,246
$
4,290
$
153,299,865
$
( 137,524,422 )
$
15,779,733
[1]
Includes gross proceeds of $ 3,607,827 less total issuance costs of $ 108,235 .
[2]
Includes gross proceeds of $ 415,588 less total issuance costs of $ 12,468 .
[3]
Includes gross proceeds of $ 11,977,468 less total cash issuance costs of $ 1,091,354 .
[4]
Shares issued as partial consideration for License Agreement with Formosa Pharmaceuticals Inc.
[5]
Includes gross proceeds of $ 100,449 less total issuance costs of $ 3,013 .
[6]
Registered direct offering included modification of warrant originally granted in the March 2022 offering.
[7] Non-cash warrant modification issuance costs related to the registered direct offering of $ 1,738,700 are shown on a separate line item.
The accompanying notes are an integral part of these condensed financial statements.
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EYENOVIA, INC.
Condensed Statements of Changes in Stockholders’ Equity
(unaudited)
For the Three and Nine Months Ended September 30, 2022
Additional
Total
Common Stock
Paid-In
Accumulated
Stockholders’
Shares
Amount
Capital
Deficit
Equity
Balance - January 1, 2022
28,426,616
$
2,844
$
110,683,077
$
( 90,219,306 )
$
20,466,615
Issuance of common stock and warrants in registered direct offering [1]
3,000,000
300
14,897,608
—
14,897,908
Issuance of common stock in At the Market offering [2]
252,449
25
860,340
—
860,365
Stock-based compensation
—
—
908,987
—
908,987
Issuance of common stock related to vested restricted stock units
19,359
2
( 2 )
—
—
Net loss
—
—
—
( 7,339,665 )
( 7,339,665 )
Balance -March 31, 2022
31,698,424
3,171
127,350,010
( 97,558,971 )
29,794,210
Exercise of stock warrants
1,870,130
187
18,514
—
18,701
Stock-based compensation
—
—
1,036,926
—
1,036,926
Issuance of common stock related to vested restricted stock units
54,499
5
( 5 )
—
—
Net loss
—
—
—
( 7,239,100 )
( 7,239,100 )
Balance - June 30, 2022
33,623,053
3,363
128,405,445
( 104,798,071 )
23,610,737
Issuance of common stock in At the Market offering [3]
1,876,314
188
3,098,506
—
3,098,694
Stock-based compensation
—
—
928,733
—
928,733
Issuance of common stock related to vested restricted stock units
26,322
2
( 2 )
—
—
Net loss
—
—
—
( 7,308,996 )
( 7,308,996 )
Balance - September 30, 2022
35,525,689
$
3,553
$
132,432,682
$
( 112,107,067 )
$
20,329,168
[1]
Includes gross proceeds of $ 14,981,299 less total issuance costs of $ 83,391 .
[2]
Includes gross proceeds of $ 886,974 , less total issuance costs of $ 26,609 .
[3]
Includes gross proceeds of $ 3,194,530 , less total issuance costs of $ 95,836 .
The accompanying notes are an integral part of these condensed financial statements.
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EYENOVIA, INC.
Condensed Statements of Cash Flows
(unaudited)
For the Nine Months Ended
September 30,
2023
2022
Cash Flows From Operating Activities
Net loss
$
( 19,293,959 )
$
( 21,887,761 )
Adjustments to reconcile net loss to net cash used in operating activities:
Stock-based compensation
1,925,665
2,874,646
Depreciation of property and equipment
505,684
228,898
Amortization of debt discount
497,654
78,645
Write-off of property and equipment
—
209,040
Write-down of inventories to net realizable value
12,218
—
Provision for returned deferred clinical supplies
400,000
—
Non-cash rent expense
403,362
—
Changes in operating assets and liabilities:
Prepaid expenses and other current assets
39,035
( 66,250 )
License fee and expense reimbursements receivables
786,772
995,635
Deferred clinical supply costs
( 1,637,756 )
( 1,871,096 )
Inventories
( 62,514 )
—
Security and equipment deposits
1,750
( 67,614 )
Accounts payable
( 2,255 )
( 509,145 )
Accrued compensation
( 371,359 )
( 275,609 )
Accrued expenses and other current liabilities
( 307,373 )
539,084
Lease liabilities
( 411,266 )
50,905
Net Cash Used In Operating Activities
( 17,514,342 )
( 19,700,622 )
Cash Flows From Investing Activities
Purchases of property and equipment
( 2,702,361 )
( 509,370 )
Vendor deposits for property and equipment
—
( 53,589 )
Investment in intangible asset
( 1,122,945 )
—
Net Cash Used In Investing Activities
( 3,825,306 )
( 562,959 )
Cash Flows From Financing Activities
Proceeds from sale of common stock and warrants in direct offering [1][2]
11,977,468
14,981,299
Payment of offering issuance costs
( 1,091,354 )
( 83,391 )
Proceeds from sale of common stock in At the Market offering
4,123,864
4,081,504
Payment of issuance costs for At the Market offering
( 123,716 )
( 122,445 )
Proceeds from exercise of stock options
27,200
18,701
Proceeds from note payable to Avenue
5,000,000
—
Payment of issuance costs for notes issued to Avenue
( 125,982 )
—
Repayments of notes payable
( 609,140 )
( 675,332 )
Net Cash Provided By Financing Activities
19,178,340
18,200,336
Net Decrease in Cash and Cash Equivalents
( 2,161,308 )
( 2,063,245 )
Cash, cash equivalents and restricted cash - Beginning of Period
22,863,520
27,336,850
Cash, cash equivalents and restricted cash - End of Period
$
20,702,212
$
25,273,605
The accompanying notes are an integral part of these condensed financial statements.
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EYENOVIA, INC.
Condensed Statements of Cash Flows, continued
(unaudited)
For the Nine Months Ended
September 30,
2023
2022
Cash, cash equivalents and restricted cash consisted of the following:
Cash and cash equivalents
$
20,702,212
$
17,398,605
Restricted cash
—
7,875,000
$
20,702,212
$
25,273,605
Supplemental Disclosure of Cash Flow Information:
Cash paid during the year for:
Interest
$
1,194,132
$
315,550
Supplemental Disclosure of Non-Cash Investing and Financing Activities
Purchase of insurance policy financed by note payable
$
609,140
$
675,332
Right-of-use assets and lease liabilities recognized upon lease renewal
$
904,437
$
—
Vendor deposits applied to purchases of property and equipment
$
39,573
$
—
Original issue discount on notes payable
$
212,500
$
—
Warrant modification - incremental value
$
1,738,700
$
—
Issuance of common stock in consideration of licensing agreement
$
1,000,000
$
—
Cashless exercise of stock options
$
2
$
—
Issuance of common stock related to vested restricted stock units
$
4
$
9
[1] For 2022, includes gross proceeds of $ 14,981,299 , of which $ 5,741,299 is pre-funded warrants.
[2] For 2023, includes gross proceeds of $ 11,977,468 , of which $ 4,168,011 is pre-funded warrants.
The accompanying notes are an integral part of these condensed financial statements.
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EYENOVIA, INC.
NOTES TO CONDENSED FINANCIAL STATEMENTS
(UNAUDITED)
Note 1 – Business Organization, Nature of Operations and Basis of Presentation
Eyenovia, Inc. (“Eyenovia” or the “Company”) is an ophthalmic technology company developing the Optejet® delivery system for use both in combination with its own drug-device therapeutic programs in mydriasis (pupil dilation), presbyopia and pediatric progressive myopia as well as out-licensing for additional indications. The Company’s investigational products are classified by the Food and Drug Administration (“FDA”) as drug-device combination products with drug primary mode of action, meaning that the Center for Drug Evaluation and Research (“CDER”), is designated as the lead center with primary jurisdictional oversight. Accordingly, the product candidates are submitted to the FDA and CDER for premarket review and approval under new drug applications (“NDAs”).
The accompanying unaudited condensed financial statements have been prepared in accordance with accounting principles generally accepted in the United States of America (“U.S. GAAP”) for interim financial information and with the instructions to Form 10-Q and Article 8 of Regulation S-X. Accordingly, they do not include all of the information and disclosures required by U.S. GAAP for complete financial statements. In the opinion of management, such statements include all adjustments (consisting only of normal recurring items) which are considered necessary for a fair presentation of the condensed financial statements of the Company as of September 30, 2023 and for the three and nine months ended September 30, 2023 and 2022. The results of operations for the nine months ended September 30, 2023 are not necessarily indicative of the operating results for the full year ending December 31, 2023 or any other period. These unaudited condensed financial statements should be read in conjunction with the audited financial statements and related disclosures of the Company as of December 31, 2022 and for the year then ended, which were included in the Company’s Annual Report on Form 10-K for the year ended December 31, 2022, filed with the Securities and Exchange Commission (“SEC”) on March 31, 2023 (the “2022 Form 10-K”), as amended by Amendment No. 1, filed with the SEC on May 1, 2023 (the “2022 Form 10-K Amendment”).
Note 2 – Going Concern and Summary of Significant Accounting Policies
Since the date of the 2022 Form 10-K, there have been no material changes to the Company’s significant accounting policies, except as disclosed below.
Going Concern
As of September 30, 2023, the Company had cash and cash equivalents in the aggregate amount of approximately $ 20.7 million. For the nine months ended September 30, 2023 and 2022, the Company incurred net losses of approximately $ 19.3 million and $ 21.9 million, respectively, and used cash in operations of approximately $ 17.5 million and $ 19.7 million, respectively. The Company does not have material recurring revenue, has not yet achieved profitability and may never become profitable. The Company expects to continue to incur cash outflows from operations. Research and development and general and administrative expenses will continue to be incurred by the Company and, as a result, the Company 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 were issued. Implementation of the Company’s plans and its ability to continue as a going concern will depend upon the Company’s ability to raise further capital through licensing transactions, the sale of additional equity or debt securities, or otherwise, to support its future operations.
The Company’s operating needs include the planned costs to operate its business, including amounts required to fund working capital and capital expenditures. The Company’s future capital requirements and the adequacy of its available funds will depend on many factors, including the Company’s ability to successfully commercialize its products and services, competing technological and market developments, and the need to enter into collaborations with other companies or acquire other companies or technologies to enhance or complement its product and service offerings. If the Company is unable to secure additional capital, it may be required to curtail its research and development initiatives and/or take additional measures to reduce general and administrative and sales and marketing costs in order to conserve its cash.
Cash and Cash Equivalents
The Company considers all highly liquid investments with an original maturity of three months or less to be cash equivalents in the financial statements.As of September 30, 2023, the Company had Treasury bills with original maturity dates of three months or less in the amount of $ 5,221,319 .
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EYENOVIA, INC.
NOTES TO CONDENSED FINANCIAL STATEMENTS
(UNAUDITED)
The Company has cash deposits in financial institutions that, at times, may be in excess of Federal Deposit Insurance Corporation (“FDIC”) insurance limits. The Company has not experienced losses in such accounts and periodically evaluates the creditworthiness of its financial institutions. As of September 30, 2023 and December 31, 2022, the Company had cash balances in excess of FDIC insurance limits of $ 15,056,184 and $ 22,613,520 , respectively.
Net Loss Per Common Share
Basic net loss per common share is computed by dividing net loss by the weighted average number of common shares outstanding during the period plus fully vested shares that are subject to issuance for little or no monetary consideration. Diluted earnings per share reflects the potential dilution that could occur if securities or other instruments to issue common stock were exercised or converted into common stock.
The following table presents the computation of basic and diluted net loss per common share:
For the Three Months Ended
For the Nine Months Ended
September 30,
September 30,
2023
2022
2023
2022
Numerator:
Net loss attributable to common stockholders
$
( 7,338,733 )
$
( 7,308,996 )
$
( 19,293,959 )
$
( 21,887,761 )
Denominator (weighted average quantities):
Common shares issued
39,107,338
34,564,366
38,192,414
32,260,723
Add: Prefunded warrants
926,225
—
305,349
445,269
Add: Undelivered vested restricted shares
106,134
67,408
65,311
72,559
Denominator for basic and diluted net loss per share
40,139,697
34,631,774
38,563,074
32,778,551
Basic and diluted net loss per common share
$
( 0.18 )
$
( 0.21 )
$
( 0.50 )
$
( 0.67 )
The following securities are excluded from the calculation of weighted average diluted common shares because their inclusion would have been anti-dilutive:
September 30,
2023
2022
Options
5,218,686
5,484,687
Warrants
10,926,554
6,087,845
Convertible notes
2,327,747
—
Restricted stock units
86,205
172,800
Total potentially dilutive shares
18,559,192
11,745,332
Clinical Supply Arrangements
Bausch + Lomb, Inc. (“B+L”) and Arctic Vision (Hong Kong) Limited (“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. The Company’s licensing agreements with Bausch + Lomb and Arctic Vision represent collaborative arrangements and they are not customers 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.
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EYENOVIA, INC.
NOTES TO CONDENSED FINANCIAL STATEMENTS
(UNAUDITED)
Inventories
Inventories are stated at the lower of cost or net realizable value. Cost is determined using the first-in, first-out method. The cost of inventory that is sold to third parties is included within cost of sales. The Company will periodically review for slow-moving, excess or obsolete inventories.
Inventory is primarily comprised of drug-device combination products, which are available for commercial sale, as follows:
September 30,
2023
Finished goods
$
24,506
Work-in-process
—
Raw materials
25,790
Total inventory
$
50,296
Intangible Assets
The application of the guidance in ASC 805 (“Business Combinations”) on accounting for business combinations can differ significantly depending on whether the acquired entity is considered a “business” or an “asset.” A determination of whether the transaction represented an asset acquisition or a business combination must be made. Pursuant to ASC 350 (“Intangibles - Goodwill and Other”), the payment made for the intangible asset will be capitalized and amortized over the useful life of the intangible asset.
On August 15, 2023 (the “Effective Date”), the Company entered into a license agreement (the “License”) with Formosa Pharmaceuticals Inc. (the “Licensor”), whereby the Company acquired the exclusive U.S. rights to commercialize any product related to a novel formulation of clobetasol propionate ophthalmic nanosuspension, 0.05 % (the “Licensed Product”), which is currently under review by the FDA for ophthalmic use for inflammation and pain after ocular surgery and supplemental disease indications, if any, associated with the New Drug Application for the Licensed Product. The License will remain in effect for ten years from the date of the first commercial sale of a Licensed Product, unless earlier terminated. The Company paid the Licensor the aggregate amount of $ 2,000,000 (the “Upfront Payment”), consisting of (a) cash in the amount of $ 1,000,000 and (b) 487,805 shares of common stock valued at $ 1,000,000 , which is included in Intangible Assets on the accompanying condensed balance sheet. In addition to the Upfront Payment, the Company also capitalized $ 122,945 of transaction costs, which were primarily legal expenses. In addition, the Company must pay the Licensor up to $ 4 million upon the achievement of certain development milestones and up to $ 80 million upon the achievement of certain sales milestones. The initial trigger for development milestone payments is FDA approval of the Licensed Product. These contingent payments will be recorded when payment becomes probable and estimable.
It was determined that the transaction represented an asset acquisition, rather than a business combination, because substantially all of the fair value of the assets acquired is concentrated in a single identifiable asset. Consequently, the accounting is pursuant to the cost accumulation model. The Upfront Payment has been capitalized as an intangible asset by the Company, and will be amortized over the useful life of 10 years beginning on the date of the first commercial sale of the Licensed Product.
Recently Adopted 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 adopted ASU 2016-13 on January 1, 2023. The adoption of ASU 2016-13 did not 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
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EYENOVIA, INC.
NOTES TO CONDENSED FINANCIAL STATEMENTS
(UNAUDITED)
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, ASU 2020-06 improves disclosure requirements for convertible instruments and earnings-per-share guidance. ASU 2020-06 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. 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 did not 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 September 30, 2023 and December 31, 2022, prepaid expenses and other current assets consisted of the following:
September 30,
December 31,
2023
2022
Payroll tax receivable
$
500,684
$
660,891
Prepaid insurance expenses
375,961
201,082
Prepaid conference expenses
345,334
97,743
Prepaid professional fees
193,750
—
Prepaid research and development expenses
155,767
2,521
Prepaid general and administrative expenses
110,659
87,982
Prepaid patent expenses
59,919
38,796
Prepaid security deposit
18,750
74,959
Other
—
26,745
Total prepaid expenses and other current assets
$
1,760,824
$
1,190,719
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EYENOVIA, INC.
NOTES TO CONDENSED FINANCIAL STATEMENTS
(UNAUDITED)
Note 4 - Property and Equipment, Net
As of September 30, 2023 and December 31, 2022, property and equipment consisted of the following:
September 30,
December 31,
2023
2022
Equipment
$
3,621,033
$
1,271,372
Equipment not yet placed in service
4,430
90,411
Leasehold improvements
1,047,424
569,170
4,672,887
1,930,953
Less: accumulated depreciation and amortization
( 1,141,522 )
( 635,838 )
Property and equipment, net
$
3,531,365
$
1,295,115
Depreciation expense was $ 318,417 and $ 82,997 for the three months ended September 30, 2023 and 2022, respectively, of which $ 316,673 and $ 80,212 , respectively, was included within research and development expenses and $ 1,744 and $ 2,785 , respectively, was included in general and administrative expenses in the accompanying statements of operations. Depreciation expense was $ 505,684 and $ 228,898 for the nine months ended September 30, 2023 and 2022, respectively, of which $ 499,535 and $ 221,031 , respectively, was included within research and development expenses and $ 6,149 and $ 7,867 , respectively, was included in general and administrative expenses in the accompanying statements of operations.
As of September 30, 2023 and December 31, 2022, the Company had $ 686,753 and $ 726,326 , respectively, of outstanding deposits for equipment purchases.
Note 5 – Accrued Compensation
As of September 30, 2023 and December 31, 2022, accrued compensation consisted of the following:
September 30,
December 31,
2023
2022
Accrued bonus expenses
$
1,048,249
$
1,447,643
Accrued payroll expenses
327,583
299,548
Total accrued compensation
$
1,375,832
$
1,747,191
Note 6 – Accrued Expenses and Other Current Liabilities
As of September 30, 2023 and December 31, 2022, accrued expenses and other current liabilities consisted of the following:
September 30,
December 31,
2023
2022
Accrued rework of clinical supply returns
$
100,000
$
—
Accrued research and development expenses
45,000
35,524
Credit card payable
53,751
50,639
Accrued consulting and professional services
46,750
320,000
Accrued franchise tax
39,300
—
Accrued leasehold improvements
—
92,528
Accrued travel and entertainment expenses
10,033
—
Other
869
4,385
Total accrued expenses and other current liabilities
$
295,703
$
503,076
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EYENOVIA, INC.
NOTES TO CONDENSED FINANCIAL STATEMENTS
(UNAUDITED)
Note 7 – Notes Payable
As of September 30, 2023 and December 31, 2022, notes payable consisted of the following:
September 30, 2023
December 31, 2022
Notes Payable
Debt Discount
Net
Notes Payable
Debt Discount
Net
Current portion:
Avenue - Note payable
$
3,333,333
$
( 327,217 )
$
3,006,116
$
208,333
$
( 33,885 )
$
174,448
Avenue - Convertible note payable
—
—
—
208,333
( 33,885 )
174,448
Total current portion
$
3,333,333
$
( 327,217 )
$
3,006,116
$
416,666
$
( 67,770 )
$
348,896
Non-Current portion:
Avenue - Note payable
$
7,304,167
$
( 754,919 )
$
6,549,248
$
5,004,167
$
( 813,229 )
$
4,190,938
Avenue - Convertible note payable
5,000,000
( 452,920 )
4,547,080
5,004,167
( 813,229 )
4,190,938
Total non-current portion
$
12,304,167
$
( 1,207,839 )
$
11,096,328
$
10,008,334
$
( 1,626,458 )
$
8,381,876
On February 24, 2023, the Company issued a note payable in the amount of $ 609,140 for the purchase of a directors and officers’ liability insurance policy (the “D&O Loan”). The note accrued interest at a rate of 7.11 % per year and matured on August 24, 2023. The D&O Loan was payable in six monthly payments of $ 103,639 consisting of principal and interest. During the nine months ended September 30, 2023, the Company fully repaid the $ 609,140 of principal owed on the D&O Loan.
On May 22, 2023, pursuant to the Company’s Loan and Security Agreement (the “Loan and Security Agreement”) with Avenue Capital Management II, L.P., and related entities (“Avenue”), the Company received an additional tranche of non-convertible debt funding in the gross amount of $ 5,250,000 (which includes a $ 250,000 final payment, or 5 % of the debt funding). The Company paid approximately $ 126,000 of origination and legal fees connected to this debt funding. The additional funding was made under the provisions of the Loan and Security Agreement, bearing 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 entire outstanding balance due under the Loan and Security Agreement has a maturity date of November 1, 2025. The additional funding triggered the extension of the interest-only period from the original 12 months to 18 months (through May 2024) for the entire outstanding balance due under the Loan and Security Agreement (initial and additional tranches). Following the interest-only period, the Company will make equal monthly payments of principal until the maturity date, plus interest.
During the three months ended September 30, 2023, the Company recorded interest expense of $ 679,222 , of which $ 677,394 (which includes amortization of debt discount of $ 184,208 ) was related to the Loan and Security Agreement with Avenue and $ 1,828 was related to the D&O Loan. During the nine months ended September 30, 2023, the Company recorded interest expense of $ 1,691,228 , of which $ 1,678,534 was related to the Loan and Security Agreement (including amortization of debt discount of $ 497,654 ) and $ 12,694 was related to the D&O Loan.
Note 8 – Commitments and Contingencies
Clinical Supply Returns
A certain portion of clinical supply product sold to a licensee has been determined to be defective and will be returned to the Company to be replaced or reworked. The defect occurred with the clinical trial Gen 1.0 device. The Company is still working to determine the exact quantity of the defective clinical supply and the cost to replace or rework the product. The current estimate of the range of the loss is between $ 400,000 and $ 600,000 , with no amount within that range being a more accurate estimate than the others at this time. Accordingly, the Company has recorded a charge equal to the low end of the range or $ 400,000 , which is included within other income (expense), because the original sales to the licensee were recorded on that line item.
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EYENOVIA, INC.
NOTES TO CONDENSED FINANCIAL STATEMENTS
(UNAUDITED)
Operating Leases
In June 2023, the Company entered into an extension agreement to renew its lease for approximately 3,800 square feet of office space in New York, NY. The lease was due to expire on October 31, 2023. The lease was extended from November 1, 2023 to December 31, 2026.
In February 2023, the Company exercised its options to renew its three leases in Redwood City, California, for a total of approximately 6,700 square feet. The leases were due to expire on August 31, 2023 . The leases were extended from September 1, 2023 to August 31, 2025.
A summary of the Company’s right-of-use assets and liabilities as follows:
For the Nine Months Ended
September 30, 2023
Cash paid for amounts included in the measurement of lease liabilities:
Operating cash flows used in operating activities
$
411,266
Right-of-use assets and lease liabilities recognized upon lease renewal
Operating leases
$
904,437
Weighted Average Remaining Lease Term (Years)
Operating leases
3.28 years
Weighted Average Discount Rate
Operating leases
10.0
%
Future minimum payments under all of the Company’s operating lease agreements are as follows:
For the Year Ending December 31,
Minimum Lease Payments
2023
$
137,838
2024
660,923
2025
675,400
2026
560,996
2027
214,619
Total future minimum lease payments
2,249,776
Less: amount representing imputed interest
( 364,079 )
Present value of lease liabilities
1,885,697
Less: current portion
( 444,616 )
Lease liabilities, non current portion
$
1,441,081
Litigations, Claims and Assessments
The Company may be involved in legal proceedings, claims and assessments arising in the ordinary course of business. The Company records legal costs associated with loss contingencies as incurred and accrues for all probable and estimable settlements.
Note 9 – Stockholders’ Equity
Equity Incentive Plan
On June 27, 2023, the Company’s stockholders approved an amendment to the Company’s Amended and Restated 2018 Omnibus Stock Incentive Plan, as amended, reserving an additional 1,000,000 shares of common stock for further issuance under such plan.
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Table of Contents
EYENOVIA, INC.
NOTES TO CONDENSED FINANCIAL STATEMENTS
(UNAUDITED)
At-The-Market Offering
During the nine months ended September 30, 2023, the Company received approximately $ 4.0 million in net proceeds from the sale of 1,464,346 shares of its common stock pursuant to its Sales Agreement with Leerink Partners, formerly known as SVB Securities LLC (“Leerink Partners”) in an ”at-the-market” offering (the “At-the-Market Offering Program”).
Registered Direct Offering
On August 24, 2023, the Company entered into a securities purchase agreement with a certain institutional and accredited investor (the “Purchaser”), pursuant to which the Company agreed to sell, in a registered direct offering by the Company directly to the Purchaser (the “August 2023 Offering”), 4,198,633 shares of common stock, pre-funded warrants to purchase up to 2,252,979 shares of common stock (the “Pre-Funded Warrants”) and warrants to purchase up to 4,838,709 shares of common stock (the “Common Warrants” and, together with the Pre-Funded Warrants, the “Warrants”). The combined offering price for each share of common stock and accompanying Common Warrant was $ 1.86 , and the combined offering price for each Pre-Funded Warrant and accompanying Common Warrant was $ 1.85 .
The Common Warrants will be exercisable beginning six months following the date of issuance and may be exercised for a period of five years from the initial exercisability date at an exercise price of $ 2.23 per share. The Pre-Funded Warrants were immediately exercisable and may be exercised at any time until all of the Pre-Funded Warrants are exercised in full at an exercise price of $ 0.01 per share. The exercise prices and numbers of shares of common stock issuable upon exercise of the Common Warrants and the Pre-Funded Warrants are subject to typical anti-dilution provisions. A holder may not exercise any portion of such holder’s Common Warrants or Pre-Funded Warrants to the extent that the holder would own more than 4.99 % of the Company’s outstanding common stock immediately after exercise (unless the holder otherwise elects a limitation of 9.99 %). The Company determined that the Warrants met the criteria to be classified as equity.
The net cash proceeds of the August 2023 Offering were approximately $ 10.9 million after deducting cash issuance costs in the aggregate amount of approximately $ 1.1 million. See Warrant Modification below for details about an additional $ 1.7 million of non-cash issuance costs. The August 2023 Offering closed on August 29, 2023.
Warrant Modification
Original Warrant Issuance - March 2022
On March 3, 2022, the Company entered into a securities purchase agreement (the “March 2022 Purchase Agreement”) with a holder (the “Holder”) relating to the issuance and sale of 3,000,000 shares of common stock, pre-funded warrants to purchase an aggregate of 1,870,130 shares of common stock and warrants to purchase an aggregate of 4,870,130 shares of common stock (the “March 2022 Investor Warrants”). The March 2022 Investor Warrants became exercisable beginning six months from the date of issuance and initially were exercisable for a period of five years at an exercise price of $ 3.54 per share.
Warrant Amendment
In connection with the August 2023 Offering (see “Registered Direct Offering” above), the Company entered into a warrant amendment agreement (the “Amendment”) with the Holder, whereby the Company agreed to amend the March 2022 Investor Warrants to (i) reduce the exercise price from $ 3.54 per share of common stock to $ 2.23 per share of common stock, (ii) extend the term of the March 2022 Investor Warrants until March 1, 2029, (iii) include a stockholder approval requirement in connection with a modification of the beneficial ownership limitation and (iv) prohibit exercise of the March 2022 Investor Warrants for the six-month period following the effective date of the Amendment.
The Company accounted for the modification of the March 2022 Investor Warrants as an exchange of the old warrants for new warrants. The incremental value of the new warrant (resulting from the decrease in exercise price from $ 3.54 to $ 2.23 per share and the extension of the warrant expiration date to March 1, 2029) was measured as the excess of the fair value of the modified warrants over the fair
15
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EYENOVIA, INC.
NOTES TO CONDENSED FINANCIAL STATEMENTS
(UNAUDITED)
value of the original warrants immediately before modification. The increase in the incremental value of $ 1,738,700 was credited to additional paid-in-capital (“APIC”) and debited to APIC as an issuance cost of the August 2023 Offering.
Warrants
A summary of the warrant activity for the nine months ended September 30, 2023 is presented below:
Weighted
Weighted
Average
Average
Remaining
Number of
Exercise
Life
Warrants
Price
In Years
Outstanding January 1, 2023
6,087,845
$
3.37
Granted
7,091,688
1.52
Repriced - Old (1)
( 4,870,130 )
3.54
Repriced - New (1)
4,870,130
2.23
Outstanding September 30, 2023
13,179,533
$
1.89
4.2
Exercisable September 30, 2023
3,470,694
$
0.95
0.7
(1)
Warrants represent the reset of the exercise price of the March 2022 Investor Warrants to purchase 4,870,130 shares of common stock to a price of $ 2.23 per share.
The following table presents information related to warrants as of September 30, 2023:
Warrants Outstanding
Warants Exercisable
Weighted
Outstanding
Average
Exercisable
Exercise
Number of
Remaining Life
Number of
Price
Warrants
In Years
Warrants
$0.0100 (1)
2,252,979
N/A
2,252,979
$2.2300 (2)
9,708,839
—
—
$ 2.4696
909,451
1.5
909,451
$ 2.7240
216,380
1.5
216,380
$ 4.7600
91,884
7.6
91,884
13,179,533
0.7
3,470,694
(1) These are Pre-Funded Warrants that do not expire.
(2) These warrants are not yet exercisable.
Stock-Based Compensation Expense
The Company records stock-based compensation expense related to stock options and restricted stock units (“RSUs”). For the three months ended September 30, 2023 and 2022, the Company recorded expense of $ 612,969 ($ 235,731 of which was included within research and development expenses and $ 377,238 was included within general and administrative expenses on the statements of operations) and $ 928,733 ($ 420,619 of which was included within research and development expenses and $ 508,114 was included within general and administrative expenses on the statements of operations), respectively. For the nine months ended September 30, 2023 and 2022, the Company recorded expense of $ 1,925,665 ($ 647,058 of which was included within research and development expenses and $ 1,278,607 was included within general and administrative expenses on the statements of operations) and $ 2,874,646 ($ 1,438,469 of which was included within research and development expenses and $ 1,436,177 was included within general and administrative expenses on the statements of operations), respectively.
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Table of Contents
EYENOVIA, INC.
NOTES TO CONDENSED FINANCIAL STATEMENTS
(UNAUDITED)
Restricted Stock Units
A summary of RSU activity during the nine months ended September 30, 2023 is presented below:
Weighted
Average
Number of
Grant Date Value
RSUs
Per Share
RSUs non-vested January 1, 2023
172,800
$
1.80
Granted
86,205
2.32
Vested
( 150,578 )
1.80
Forfeited
( 22,222 )
1.80
RSUs non-vested September 30, 2023
86,205
$
2.32
Vested RSUs undelivered September 30, 2023
135,745
$
2.22
To date, RSUs have only been granted to directors in accordance with the Company’s Amended and Restated 2018 Omnibus Stock Incentive Plan. The Company’s policy is to defer settlement of such RSUs until the termination of such director’s service on the Company’s board of directors. On February 28, 2023, the Company delivered 3,289 shares of common stock in respect of RSUs upon the resignation of a director. On June 16, 2023, the Company delivered 44,444 shares of common stock in respect of RSUs based on the prior resignation of two directors.
As of September 30, 2023, there was $ 203,055 of unrecognized stock-based compensation expense related to RSUs which will be recognized over a weighted average period of 1.0 years.
Stock Options
In applying the Black-Scholes option pricing model to stock options granted, the Company used the following approximate assumptions:
For the Three Months Ended
For the Nine Months Ended
September 30,
September 30,
2023
2022
2023
2022
Expected term (years)
N/A
5.41 - 5.85
5.50 - 10.00
0.58 - 10.00
Risk free interest rate
N/A
2.66 % - 3.02 %
3.44 % - 4.18 %
0.76 % - 3.35 %
Expected volatility
N/A
85 % - 87 %
82 % - 95 %
82 % - 90 %
Expected dividends
N/A
0.00 %
0.00 %
0.00 %
The Company has computed the fair value of stock options granted using the Black-Scholes option pricing model. Option forfeitures are accounted for at the time of occurrence. The expected term is the estimated period of time that options granted are expected to be outstanding. The Company utilizes the “simplified” method to develop an estimate of the expected term of “plain vanilla” employee option grants. The Company uses a blended volatility calculation, the components of which are the Company’s historical volatility for the period from its initial public offering through the valuation date and the average peer-group data of six comparable entities to supplement the Company’s own historical data for the preceding years in computing the expected volatility. Accordingly, the Company is utilizing an expected volatility figure based on a review of the historical volatility of comparable entities over a period of time equivalent to the expected life of the instrument being valued. The risk-free interest rate was determined from the implied yields from U.S. Treasury zero-coupon bonds with a remaining term consistent with the expected term of the instrument being valued. The Company has not declared dividends, is currently in the development stage and has no plan to declare future dividends at this time.
There were no options granted in the three months ended September 30, 2023. The weighted average estimated grant date fair value of the stock options granted for the three months ended September 30, 2022 was approximately $ 1.22 per share. The weighted average estimated grant date fair value of the stock options granted for the nine months ended September 30, 2023 and 2022 was approximately $ 1.70 and $ 1.61 per share respectively.
17
Table of Contents
EYENOVIA, INC.
NOTES TO CONDENSED FINANCIAL STATEMENTS
(UNAUDITED)
A summary of the option activity during the nine months ended September 30, 2023 is presented below:
Average
Remaining
Aggregate
Number of
Exercise
Life
Intrinsic
Options
Price
In Years
Value
Outstanding, January 1, 2023
5,380,553
$
3.55
Granted
797,190
2.29
Exercised
( 88,999 )
1.83
Forfeited/ Expired
( 870,058 )
3.86
Outstanding September 30, 2023
5,218,686
$
3.33
7.0
$
59,408
Exercisable September 30, 2023
3,835,305
$
3.62
6.2
$
59,408
The following table presents information related to stock options as of September 30, 2023:
Options Outstanding
Options Exercisable
Weighted
Outstanding
Average
Exercisable
Exercise
Number of
Remaining Life
Number of
Price
Options
In Years
Options
$ 1.00 - $ 1.99
1,493,849
5.3
1,067,990
$ 2.00 - $ 2.99
1,450,105
6.7
841,000
$ 3.00 - $ 3.99
898,528
6.7
717,140
$ 4.00 - $ 4.99
333,000
7.9
224,429
$ 5.00 - $ 5.99
50,805
4.0
50,638
$ 6.00 - $ 6.99
843,759
6.3
785,468
$ 7.00 +
148,640
4.5
148,640
5,218,686
6.2
3,835,305
As of September 30, 2023, there was $ 2,841,102 of unrecognized stock-based compensation expense related to stock options, which will be recognized over a weighted average period of 1.8 years.
Note 10 – Employee Benefit Plans
401(k) Plan
In April 2019, the Company adopted the Eyenovia 401(k) Plan (the “Plan”), which went into effect in May 2019. All Company employees are able to participate in the Plan, subject to eligibility requirements as outlined in the Plan documents. Under the terms of the Plan, eligible employees are able to defer a percentage of their pay every pay period up to annual limitations set by Congress and the Internal Revenue Service under Section 401(k) of the Internal Revenue Code. For 2023 and 2022, the Company’s Board of Directors approved a matching contribution equal to 100 % of elective deferrals up to 4 % of eligible earnings with the matching contribution subject to certain vesting requirements as outlined in the Plan documents. During the three months ended September 30, 2023 and 2022, the Company recorded expense of $ 46,636 and $ 39,914 associated with its matching contributions, respectively. During the nine months ended September 30, 2023 and 2022, the Company recorded expense of $ 171,800 and $ 173,896 associated with its matching contributions, respectively.
18
Table of Contents
EYENOVIA, INC.
NOTES TO CONDENSED FINANCIAL STATEMENTS
(UNAUDITED)
Note 11 - Subsequent Events
Exercise of Pre-Funded Warrants
On November 2, 2023, the Purchaser exercised a portion of its Pre-Funded Warrants in order to purchase 1,223,979 of the Company’s common stock at the exercise price of $ 0.01 per share. The total proceeds of the transaction were $ 12,240 (see “Registered Direct Offering” in Note 9 – Stockholders’ Equity).
19
Table of Contents
Text extracted from the filing as submitted to EDGAR. Formatting, tables and exhibits are simplified for reading; the original document is authoritative for anything you rely on.