Item 1. Financial Statements
Item 1. Financial Statements.
EYENOVIA, INC.
Condensed Balance Sheets
June 30,
December 31,
2024
2023
(unaudited)
Assets
Current Assets
Cash and cash equivalents
$
2,300,852
$
14,849,057
Inventories
3,052,142
109,798
Deferred clinical supply costs
412,140
4,256,793
License fee and expense reimbursements receivable
124,173
123,833
Security deposits, current
—
1,506
Prepaid expenses and other current assets
1,394,313
1,365,731
Total Current Assets
7,283,620
20,706,718
Property and equipment, net
3,041,462
3,374,384
Deferred offering costs
170,632
—
Security deposits, non-current
197,168
197,168
Intangible assets
6,122,945
2,122,945
Prepaid expenses, non-current
58,693
—
Operating lease right-of-use asset
1,408,999
1,666,718
Equipment deposits
711,441
711,441
Total Assets
$
18,994,960
$
28,779,374
Liabilities and Stockholders’ (Deficiency) Equity
Current Liabilities:
Accounts payable
$
1,436,665
$
1,753,172
Accrued compensation
1,278,178
1,658,613
Accrued expenses and other current liabilities
2,988,128
287,928
Operating lease liabilities - current portion
600,379
501,250
Notes payable - current portion, net of debt discount of $ 692,567 and $ 503,914 as of June 30, 2024 and December 31, 2023, respectively
8,730,043
5,329,419
Convertible notes payable - current portion, net of debt discount of $ 18,117 and $ 0 as of June 30, 2024 and December 31, 2023, respectively
815,216
—
Total Current Liabilities
15,848,609
9,530,382
Operating lease liabilities - non-current portion
983,839
1,292,667
Notes payable - non-current portion, net of debt discount of $ 0 and $ 448,367 as of June 30, 2024 and December 31, 2023, respectively
637,500
4,355,800
Convertible notes payable - net of debt discount of $ 271,752 and $ 398,569 as of June 30, 2024 and December 31, 2023, respectively
3,894,915
4,601,431
Total Liabilities
21,364,863
19,780,280
Commitments and contingencies (Note 8)
Stockholders’ (Deficiency) Equity:
Preferred stock, $ 0.0001 par value, 6,000,000 shares authorized; 0 shares issued and outstanding as of June 30, 2024 and December 31, 2023
—
—
Common stock, $ 0.0001 par value, 300,000,000 shares authorized; 55,817,921 and 45,553,026 shares issued and outstanding as of June 30, 2024 and December 31, 2023, respectively
5,582
4,555
Additional paid-in capital
165,091,874
154,486,098
Accumulated deficit
( 167,467,359 )
( 145,491,559 )
Total Stockholders' (Deficiency) Equity
( 2,369,903 )
8,999,094
Total Liabilities and Stockholders' (Deficiency) Equity
$
18,994,960
$
28,779,374
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 Six Months Ended
June 30,
June 30,
2024
2023
2024
2023
Operating Income
Revenue
$
22,625
$
—
$
27,618
$
—
Cost of revenue
( 490,361 )
—
( 693,388 )
—
Gross Loss
( 467,736 )
—
( 665,770 )
—
Operating Expenses:
Research and development
4,597,173
2,811,061
9,028,774
5,333,011
General and administrative
3,758,835
3,149,809
7,396,024
6,086,695
Reacquisition of license rights
2,864,600
—
4,864,600
—
Total Operating Expenses
11,220,608
5,960,870
21,289,398
11,419,706
Loss From Operations
( 11,688,344 )
( 5,960,870 )
( 21,955,168 )
( 11,419,706 )
Other Income (Expense):
Other income (expense), net
2,980
119,450
( 94,578 )
190,443
Change in fair value of equity consideration payable
1,240,800
—
1,240,800
—
Interest expense
( 674,001 )
( 558,003 )
( 1,352,659 )
( 1,012,006 )
Interest income
64,866
183,563
185,805
286,043
Total Other Income (Expense)
634,645
( 254,990 )
( 20,632 )
( 535,520 )
Net Loss
$
( 11,053,699 )
$
( 6,215,860 )
$
( 21,975,800 )
$
( 11,955,226 )
Net Loss Per Share - Basic and Diluted
$
( 0.21 )
$
( 0.16 )
$
( 0.44 )
$
( 0.32 )
Shares Outstanding - Basic and Diluted
53,121,760
38,093,826
49,864,275
37,753,694
The accompanying notes are an integral part of these condensed financial statements.
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EYENOVIA, INC.
Condensed Statements of Changes in Stockholders’ (Deficiency) Equity
(unaudited)
For the Three and Six Months Ended June 30, 2024
Additional
Total
Common Stock
Paid-In
Accumulated
Stockholders’
Shares
Amount
Capital
Deficit
(Deficiency) Equity
Balance - January 1, 2024
45,553,026
$
4,555
$
154,486,098
$
( 145,491,559 )
$
8,999,094
Issuance of common stock in At the Market offering [1]
1,833,323
183
3,194,364
—
3,194,547
Stock-based compensation
—
—
546,232
—
546,232
Net loss
—
—
—
( 10,922,101 )
( 10,922,101 )
Balance - March 31, 2024
47,386,349
4,738
158,226,694
( 156,413,660 )
1,817,772
Issuance of common stock in registered direct offering [2]
3,223,726
322
1,888,507
—
1,888,829
Issuance of common stock as consideration for licensing agreement [3]
613,496
62
436,747
—
436,809
Issuance of common stock as consideration for reacquisition of licensing agreement [4]
2,299,397
230
2,322,161
—
2,322,391
Issuance of common stock in At the Market offering [5]
2,294,953
230
1,676,709
—
1,676,939
Stock-based compensation
—
—
541,056
—
541,056
Net loss
—
—
—
( 11,053,699 )
( 11,053,699 )
Balance - June 30, 2024
55,817,921
$
5,582
$
165,091,874
$
( 167,467,359 )
$
( 2,369,903 )
[1] Includes gross proceeds of $ 3,293,347 less total issuance costs of $ 98,800 .
[2] Includes gross proceeds of $ 2,000,000 , less total issuance costs of $ 111,171 .
[3] Shares issued as partial consideration for License Agreement with Formosa Pharmaceuticals Inc.
[4] Shares issued as partial consideration for reversion of License Agreement with Bausch & Lomb Ireland Limited.
[5] Includes gross proceeds of $ 1,728,804 less total issuance costs of $ 51,865 .
For the Three and Six Months Ended June 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
[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 .
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 Six Months Ended
June 30,
2024
2023
Cash Flows From Operating Activities
Net loss
$
( 21,975,800 )
$
( 11,955,226 )
Adjustments to reconcile net loss to net cash used in operating activities:
Stock-based compensation
1,087,288
1,312,696
Change in fair value of equity consideration payable
( 1,240,800 )
—
Depreciation of property and equipment
543,124
187,267
Amortization of debt discount
368,414
313,446
Write-off of property and equipment
85,051
—
Write-down of inventories to net realizable value
665,770
—
Reacquisition of license rights
2,864,600
—
Non-cash rent expense
257,719
280,968
Changes in operating assets and liabilities:
Prepaid expenses and other current assets
417,775
( 1,514 )
License fee and expense reimbursement receivables
( 340 )
754,780
Deferred clinical supply costs
377,365
( 1,293,395 )
Inventories
( 140,826 )
—
Security and equipment deposits
1,506
1,750
Accounts payable
( 316,508 )
( 115,534 )
Accrued compensation
( 380,435 )
( 734,073 )
Accrued expenses and other current liabilities
( 470,432 )
( 139,645 )
Lease liabilities
( 209,699 )
( 284,996 )
Net Cash Used In Operating Activities
( 18,066,228 )
( 11,673,476 )
—
Cash Flows From Investing Activities
Purchases of property and equipment
( 159,853 )
( 2,122,197 )
Net Cash Used In Investing Activities
( 159,853 )
( 2,122,197 )
Cash Flows From Financing Activities
Proceeds from sale of common stock and warrants in registered direct offering
2,000,000
—
Payment of registered direct offering issuance costs
( 111,171 )
—
Proceeds from sale of common stock in At the Market offering
5,022,151
4,023,414
Payment of issuance costs for At the Market offering
( 150,665 )
( 120,702 )
Proceeds from exercise of stock options
—
27,200
Proceeds from note payable and equity issued to Avenue
—
5,000,000
Payment of issuance costs for notes issued to Avenue
—
( 125,982 )
Repayments of notes payable
( 1,082,439 )
( 403,689 )
Net Cash Provided By Financing Activities
5,677,876
8,400,241
Net Decrease in Cash and Cash Equivalents
( 12,548,205 )
( 5,395,432 )
Cash and Cash Equivalents - Beginning of Period
14,849,057
22,863,520
Cash and Cash Equivalents - End of Period
$
2,300,852
$
17,468,088
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 Six Months Ended
June 30,
2024
2023
Supplemental Disclosure of Cash Flow Information:
Cash paid during the period for:
Interest
$
984,246
$
699,116
Supplemental Disclosure of Non-Cash Investing and Financing Activities
Purchase of insurance policy financed by note payable
$
505,050
$
609,140
Accrual for intangible asset milestone obligation
$
2,000,000
$
—
Reclassification of deferred clinical supply costs to inventories
$
2,801,518
$
—
Right-of-use assets obtained in exchange for lease liabilities
$
—
$
904,437
Vendor deposits applied to purchases of property and equipment
$
—
$
468,376
Original issue discount on notes payable
$
—
$
212,500
Cashless exercise of stock options
$
—
$
2
Common stock issued in consideration for licensing agreement
$
436,809
$
—
Common stock issued in consideration for reacquisition of licensing agreement
$
2,322,391
$
—
Issuance of common stock related to vested restricted stock units
$
—
$
4
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 a commercial-stage ophthalmic pharmaceutical technology company developing a pipeline of microdose array print therapeutics based on its Optejet platform. MicroPine, its leading late-stage candidate for the multi-billion dollar pediatric progressive myopia market has been licensed to Arctic Vision (Hong Kong) Limited (“Arctic Vision”) in China and South Korea. In the United States, Eyenovia is also focused on the commercialization of its two Food and Drug Administration (“FDA”)-approved products: Mydcombi (tropicamide and phenylephrine ophthalmic HCI spray) 1%/2.5% for mydriasis, as well as clobetasol propionate ophthalmic suspension 0.05% to reduce pain and inflammation following ocular surgery.
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 June 30, 2024 and for the three and six months ended June 30, 2024 and 2023. The results of operations for the three and six months ended June 30, 2024 are not necessarily indicative of the operating results for the full year ending December 31, 2024 or any other period. These unaudited condensed financial statements should be read in conjunction with the audited financial statements and related disclosures of the Company as of December 31, 2023 and for the year then ended, which were included in the Company’s Annual Report on Form 10-K for the year ended December 31, 2023, filed with the Securities and Exchange Commission (“SEC”) on March 18, 2024 (the “2023 Form 10-K”), as amended by Amendment No. 1, filed with the SEC on April 26, 2024 (the “2023 Form 10-K Amendment”).
Note 2 – Summary of Significant Accounting Policies
The Company disclosed its significant accounting policies in Note 2 – Summary of Significant Accounting Policies included in the 2023 Form 10-K. There have been no material changes to the Company’s significant accounting policies during the six months ended June 30, 2024, except as disclosed below.
Liquidity and Going Concern
As of June 30, 2024, the Company had unrestricted cash and cash equivalents of approximately $ 2.3 million and an accumulated deficit of approximately $ 167.5 million. For the six months ended June 30, 2024 and 2023, the Company incurred net losses of approximately $ 22.0 million and $ 12.0 million, respectively, and used cash in operations of approximately $ 18.1 million and $ 11.7 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 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. Additionally, the Company will need to raise further capital, through the sale of additional equity or debt securities. On July 1, 2024, the Company raised $ 5.0 million of gross proceeds from a registered direct offering of equity securities. Also, subsequent to June 30, 2024, the Company raised $ 0.8 million of gross proceeds from its ongoing “at-the-market” offering. See Note 11 – Subsequent Events for additional details. 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.
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 June 30, 2024 and December 31, 2023, the Company had Treasury bills with original maturity dates of three months or less in the amounts of $ 0 and $ 5,450,118 , respectively.
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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 June 30, 2024 and December 31, 2023, the Company had cash and cash equivalent balances in excess of FDIC insurance limits of $ 1,573,044 and $ 14,243,870 , respectively.
Clinical Supply Arrangements
Bausch + Lomb Ireland Limited (“Bausch + Lomb”) and Arctic Vision had contracted with the Company to manufacture and supply them with the appropriate drug-device combination products to conduct their clinical trials on a cost plus 10 % mark-up basis. Pursuant to the Letter Agreement (as defined below) with Bausch + Lomb, as referenced in Note 8 – Commitments and Contingencies – Bausch License Agreements, the arrangement with Bausch + Lomb has been terminated, and all rights have been repurchased by Eyenovia. The arrangement with Arctic Vision is still in place. The Company’s licensing agreement with Arctic Vision represents a collaborative arrangement and Arctic Vision is not a customer with respect to the clinical supply arrangements. The Company’s policy is to (a) defer the materials and manufacturing costs in order to properly match them up against the income from the clinical supply arrangements; and (b) report the net income from the clinical supply arrangements as other income. Deferred clinical supply costs were $ 0.4 million and $ 4.3 million at June 30, 2024 and December 31, 2023, respectively. See Note 8 – Commitments and Contingencies –Defective Clinical Supply for additional information.
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:
June 30,
December 31,
2024
2023
Finished goods
$
286,236
$
30,683
Raw materials
2,765,906
79,115
Total inventory
$
3,052,142
$
109,798
The Company has evaluated the net realizable value of the commercial inventory. The write-down of commercial inventory to net realizable value for the three months ended June 30, 2024 and 2023 was $ 0.5 million and $ 0.0 million, respectively. The write-down of commercial inventory for the six months ended June 30, 2024 and 2023 was $ 0.7 million and $ 0.0 million, respectively, which consisted of $ 0.2 million of inventory write down of adjustments to list price for the first quarter of 2024 and $ 0.5 million for the write-down of short dated inventory to net realizable value for the second quarter of 2024. The Company recorded the write-downs to cost of revenue as it relates to goods that were part of commercial inventory during 2024.
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EYENOVIA, INC.
NOTES TO CONDENSED FINANCIAL STATEMENTS
(UNAUDITED)
Net Loss Per Share of Common Stock
Basic net loss per share of common stock is computed by dividing net loss by the weighted average number of shares of common stock outstanding during the period, plus fully vested shares that are subject to issuance for little or no monetary consideration. Diluted loss per share reflects the potential dilution that could occur if securities or other instruments to issue common stock were exercised or converted into common stock. The following table presents the computation of basic and diluted net loss per common share:
For the Three Months Ended
For the Six Months Ended
June 30,
June 30,
2024
2023
2024
2023
Numerator:
Net loss attributable to common stockholders
$
( 11,053,699 )
$
( 6,215,860 )
$
( 21,975,800 )
$
( 11,955,226 )
Denominator (weighted average quantities):
Common shares issued
52,965,044
38,064,215
49,718,045
37,724,083
Add: Undelivered vested restricted shares
156,716
29,611
146,230
29,611
Denominator for basic and diluted net loss per share
53,121,760
38,093,826
49,864,275
37,753,694
Basic and diluted net loss per common share
$
( 0.21 )
$
( 0.16 )
$
( 0.44 )
$
( 0.32 )
The following securities are excluded from the calculation of weighted average diluted shares of common stock because their inclusion would have been anti-dilutive:
June 30,
2024
2023
Warrants
10,926,554
5,185,078
Options
6,599,389
6,087,845
Convertible notes
2,327,747
2,327,747
Restricted stock units
368,886
86,205
Total potentially dilutive shares
20,222,576
13,686,875
Subsequent Events
The Company has evaluated subsequent events through the date which the financial statements were issued. Based upon the evaluation, the Company did not identify any recognized or non-recognized subsequent events that would have required adjustment or disclosure in the financial statements, except as disclosed.
Recently Issued Accounting Standards
In November 2023, the FASB issued ASU 2023-07, Improvements to Reportable Segments Disclosures (Topic 280), which updates reportable segment disclosure requirements, primarily through enhanced disclosures about significant segment expenses on both an annual and interim basis. The guidance becomes effective for fiscal years beginning after December 15, 2023 and interim periods within fiscal years beginning after December 15, 2024, with early adoption permitted. Since this new ASU addresses only disclosures, the Company does not expect the adoption of this ASU to have any material effects on its financial condition, results of operations or cash flows. The Company is currently evaluating any new disclosures that may be required upon adoption of ASU 2023-07.
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EYENOVIA, INC.
NOTES TO CONDENSED FINANCIAL STATEMENTS
(UNAUDITED)
In December 2023, the FASB issued ASU 2023-09, Income Taxes (Topic 740): Improvements to Income Tax Disclosures. The amendments in this update address investor requests for more transparency about income tax information through improvements to income tax disclosures primarily related to the rate reconciliation and income taxes paid information. This update also includes certain other amendments to improve the effectiveness of income tax disclosures. The amendments in ASU 2023-09 are effective for fiscal years beginning after December 15, 2024, with early adoption permitted. The Company is currently evaluating the impact of this standard, but does not expect it to have a material impact on its financial statements.
Note 3 – Prepaid Expenses and Other Current Assets
As of June 30, 2024 and December 31, 2023, prepaid expenses and other current assets consisted of the following:
June 30,
December 31,
2024
2023
Prepaid insurance expenses
$
568,997
$
167,338
Payroll tax receivable
305,981
500,684
Prepaid research and development expenses
65,769
421,056
Prepaid conference expenses
36,765
123,556
Prepaid general and administrative expenses
270,401
85,938
Prepaid patent expenses
88,483
48,409
Prepaid rent and security deposit
18,750
18,750
Prepaid professional fees
6,667
—
Prepaid board of directors fees
32,500
—
Total prepaid expenses and other current assets
$
1,394,313
$
1,365,731
Note 4 - Intangible Assets
On August 15, 2023 (the “Effective Date”), the Company entered into a license agreement (the “License”) with Formosa Pharmaceuticals Inc. (“Formosa”), whereby the Company acquired the exclusive U.S. rights to commercialize any product related to a novel formulation of clobetasol propionate ophthalmic suspension, 0.05 % (the “Licensed Product”), which was approved by the FDA for ophthalmic use for inflammation and pain after ocular surgery and supplemental disease indications, if any, associated with the New Drug Application for the 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 Formosa the aggregate amount of $ 2.0 million (the “Upfront Payment”), consisting of (a) cash in the amount of $ 1.0 million and (b) 487,805 shares of common stock, which is included in Intangible Assets on the accompanying balance sheet. The Company also capitalized $ 122,945 of transaction costs, which were primarily legal expenses. In addition to the Upfront Payment, the Company must pay Formosa up to $ 4.0 million upon the achievement of certain development milestones and up to $ 80.0 million upon the achievement of certain sales milestones. The trigger for the initial $ 2.0 million development milestone payments was FDA approval of the Licensed Product and the effective date of the acceptance by the Company of the transfer and assignment of the FDA approval. This occurred on March 14, 2024. Under the provisions of the License, the Company had 45 days from the effective date of acceptance of the transfer and assignment of FDA approval to make the payment half in cash and half in common stock, otherwise the payment due would revert to be fully in cash. The Company paid Formosa the aggregate amount of $ 2.0 million, consisting of (a) cash in the amount of $ 1.0 million on April 26, 2024 and (b) 613,496 shares of common stock on April 29, 2024 (calculated pursuant to the License using a five-day volume-weighted average price on March 14, 2024, but valued at $ 0.4 million on the April 29, 2024 settlement date, resulting in a $ 0.6 million change in fair value of the equity consideration payable), which is included in Intangible Assets on the accompanying balance sheet as of June 30, 2024. The second $ 2.0 million development milestone (to be fully paid in cash) was earned upon FDA approval of the Licensed Product and payment was triggered on the earlier of twelve months after FDA approval or six months following the first commercial sale of the Licensed Product. Because the payment became probable and estimable, the Company recorded an additional $ 2.0 million increase in the intangible asset and the related accrual on March 14, 2024.
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EYENOVIA, INC.
NOTES TO CONDENSED FINANCIAL STATEMENTS
(UNAUDITED)
Note 5 – Accrued Compensation
As of June 30, 2024 and December 31, 2023, accrued compensation consisted of the following:
June 30,
December 31,
2024
2023
Accrued bonus expenses
$
808,787
$
1,302,997
Accrued payroll expenses
469,391
355,616
Total accrued compensation
$
1,278,178
$
1,658,613
Note 6 – Accrued Expenses and Other Current Liabilities
As of June 30, 2024 and December 31, 2023, accrued expenses and other current liabilities consisted of the following:
June 30,
December 31,
2024
2023
Accrued intangible asset milestone obligation
$
2,000,000
$
—
Accrued defective clinical supply settlement, net
250,000
100,000
Accrued research and development expenses
455,520
89,872
Accrued professional services
239,201
63,028
Credit card payable
31,967
27,193
Accrued franchise tax
10,000
—
Other
1,440
7,835
Total accrued expenses and other current liabilities
$
2,988,128
$
287,928
Note 7 – Notes Payable and Convertible Notes Payable
As of June 30, 2024 and December 31, 2023, notes payable and convertible notes payable consisted of the following:
June 30, 2024
December 31, 2023
Notes Payable
Debt Discount
Net
Notes Payable
Debt Discount
Net
Current portion:
D&O insurance policy loan
$
255,943
$
—
$
255,943
$
—
$
—
$
—
Avenue - Note payable
9,166,667
( 692,567 )
8,474,100
5,833,333
( 503,914 )
5,329,419
Avenue - Convertible note payable
833,333
( 18,117 )
815,216
—
—
—
Total current portion
$
10,255,943
$
( 710,684 )
$
9,545,259
$
5,833,333
$
( 503,914 )
$
5,329,419
Non-Current portion:
Avenue - Note payable
$
637,500
$
—
$
637,500
$
4,804,167
$
( 448,367 )
$
4,355,800
Avenue - Convertible note payable
4,166,667
( 271,752 )
3,894,915
5,000,000
( 398,569 )
4,601,431
Total non-current portion
$
4,804,167
$
( 271,752 )
$
4,532,415
$
9,804,167
$
( 846,936 )
$
8,957,231
On February 24, 2024, the Company issued a note payable in the amount of $ 505,050 for the purchase of a directors and officers’ liability insurance policy (the “D&O Loan”). The note accrues interest at a rate of 8.15 % per year and matures on October 24, 2024. The D&O Loan is payable in eight monthly payments of $ 65,076 consisting of principal and interest. During the six months ended June 30, 2024, the Company repaid $ 249,107 of principal owed on the D&O Loan.
In June 2024, the Company made its initial principal payment related to that certain loan and security agreement (the “Loan and Security Agreement”) with Avenue Capital Management II, L.P. and related entities (together, “Avenue”) in the amount of $ 833,333 plus interest.
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EYENOVIA, INC.
NOTES TO CONDENSED FINANCIAL STATEMENTS
(UNAUDITED)
During the three months ended June 30, 2024, the Company recorded interest expense of $ 674,001 , of which $ 666,235 (including amortization of debt discount of $ 184,207 ) was related to the Avenue loan and $ 7,767 was related to the D&O Loan. During the six months ended June 30, 2024, the Company recorded interest expense of $ 1,352,659 , of which $ 1,341,462 was related to the Loan and Security Agreement (including amortization of debt discount of $ 368,414 ) and $ 11,197 was related to the D&O Loan.
Note 8 – Commitments and Contingencies
Defective Clinical Supply
During the third quarter of 2023, a certain portion of clinical supply product sold to Bausch + Lomb was determined to be defective. On April 23, 2024, the Company and Bausch + Lomb executed a letter agreement (the “Side Letter”) pursuant to which the Company and Bausch + Lomb agreed that the Company would pay approximately $ 0.5 million to Bausch + Lomb related to the defective clinical supply. Accordingly, the Company recorded an estimated charge equal to $ 0.4 million, which was included within other income (expense) during the year ended December 31, 2023, because the original sales to the licensee were recorded on that line item. During the three and six months ended June 30, 2024, the Company recorded no additional charge and a $ 0.1 million charge, respectively, to other income (expense).
Bausch License Agreements
On October 9, 2020, the Company entered into a license agreement (the Bausch License Agreement”), pursuant to which Bausch + Lomb was permitted to develop and commercialize the Bausch Licensed Product (as defined in the Bausch License Agreement) in the United States and Canada (the “Licensed Territory”). Bausch + Lomb could terminate the Bausch License Agreement, with respect to the Bausch Licensed Product to either country in the Licensed Territory, at any time for convenience upon 90 days’ written notice.
On January 12, 2024, the Company and Bausch + Lomb entered into a mutual termination and reassignment agreement (the “Letter Agreement”), pursuant to which Eyenovia reacquired the rights to the Bausch Licensed Product. The terms of the agreement include the immediate transfer of the rights and the subsequent transfer of certain assets relating to the Bausch Licensed Product from Bausch + Lomb to the Company in exchange for cash and common stock consideration. In addition, under the terms of the Letter Agreement, the Company agreed to pay Bausch + Lomb a low single-digit royalty on its net sales of the Bausch Licensed Product in the United States and Canada for a period of ten years from the date of the first commercial sale by the Company (or its affiliates or licensees) of the Bausch Licensed Product in the United States. Under the Letter Agreement, (i) the Company will re-acquire any and all licenses and other rights granted by the Company to Bausch + Lomb under the original Bausch License Agreement, (ii) any and all licenses and other rights granted by Bausch + Lomb to the Company under the License Agreement are terminated, other than as set forth in the Letter Agreement, and (iii) other than as set forth in the Letter Agreement, Bausch + Lomb is released from all of their ongoing obligations under the License Agreement, including development and commercialization obligations.
Pursuant to the Letter Agreement, the Company paid Bausch + Lomb an upfront payment of $ 2.0 million in cash on January 22, 2024. The Company has recorded this amount as an operating expense. In connection with the entry into the Letter Agreement, the Company also agreed to issue Bausch + Lomb $ 3.0 million in shares of the Company’s common stock, following the Regulatory Transfer Date (the “Transfer Date”). On April 11, 2024, the Transfer Date, the transfer of the rights and certain assets relating to the CHAPERONE trial from Bausch + Lomb to the Company, was completed. On May 3, 2024, the Company issued Bausch + Lomb 2,299,397 shares of the Company’s common stock (calculated pursuant to the Letter Agreement at $ 3.0 million using a thirty-day volume-weighted average price on April 11, 2024, but valued at $ 2.3 million on the May 3, 2024 settlement date, resulting in a $ 0.7 million change in fair value of the equity consideration payable), in satisfaction of its obligations pursuant to the Letter Agreement.
Pursuant to the Side Letter described above (see Defective Clinical Supply), the Company agreed to pay approximately $ 0.5 million to Bausch + Lomb related to the defective clinical supply. It was also agreed that the Company will receive approximately $ 0.25 million from Bausch + Lomb to fund the vendor hold back liability that will be due upon completion of the CHAPERONE study.The Company has recorded the payable to Bausch + Lomb in the amount of $ 0.25 million. In addition, the Company purchased $ 0.5 million of clinical supplies from Bausch + Lomb in April 2024.
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EYENOVIA, INC.
NOTES TO CONDENSED FINANCIAL STATEMENTS
(UNAUDITED)
Operating Leases
A summary of the Company’s right-of-use assets and liabilities is as follows:
For the Six Months Ended June 30,
2024
2023
Cash paid for amounts included in the measurement of lease liabilities:
Operating cash flows used in operating activities
$
209,699
$
284,996
Right-of-use assets obtained in exchange for lease obligations
Operating leases
$
—
$
904,437
Weighted Average Remaining Lease Term (Years)
Operating leases
2.59
years
3.50
years
Weighted Average Discount Rate
Operating leases
10.0
%
10.0
%
Future minimum payments under the Company’s operating lease agreements are as follows:
For the Years Ending December 31,
Minimum Lease Payments
2024
$
364,928
2025
675,400
2026
560,996
2027
214,618
Total future minimum lease payments
1,815,942
Less: Imputed interest
( 231,724 )
Present value of lease liabilities
1,584,218
Less: current portion
( 600,379 )
Lease liabilities, non-current portion
$
983,839
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’ (Deficiency) Equity
Increase in Authorized Number of Shares of Common Stock
On June 12, 2024, at the Annual Shareholders’ Meeting, the Company proposed and the shareholders approved an increase in authorized number of shares of common stock from 90,000,000 to 300,000,000 at the same par value of $ 0.0001 per share.
Common Stock Issuances
Pursuant to the License and certain milestone achievements, the Company issued 613,496 shares of common stock valued at $ 0.4 million on April 29, 2024 to Formosa (see Note 4 – Intangible Assets).
On May 3, 2024, the Company issued Bausch + Lomb 2,299,397 shares of the Company’s common stock, valued at $ 2.3 million, in satisfaction of its obligations pursuant to the Letter Agreement (see Note 8 – Commitments and Contingencies).
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EYENOVIA, INC.
NOTES TO CONDENSED FINANCIAL STATEMENTS
(UNAUDITED)
At-The-Market Offering
During the six months ended June 30, 2024, the Company received approximately $ 4.9 million in net proceeds from the sale of 4,128,276 shares of its common stock pursuant to a sales agreement (the “Sales Agreement”) with Leerink Partners, LLC, formerly known as SVB Securities LLC (“Leerink Partners”) in an ”at-the-market” offering.
Registered Direct Offering
On April 8, 2024, the Company entered into a securities purchase agreement (the “Purchase Agreement”) with a single fundamentals-based healthcare investor (the “Purchaser”), pursuant to which the Company agreed to sell, in a registered direct offering by the Company directly to the Purchaser (the “Offering”), 3,223,726 shares of common stock, par value $ 0.0001 per share. The price per share in the Offering was $ 0.6204 . The aggregate gross proceeds to the Company from the Offering were $ 2.0 million, and net proceeds after offering costs were approximately $ 1.9 million.
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 June 30, 2024 and 2023, the Company recorded stock-based compensation expense of $ 541,056 ($ 232,154 of which was included within research and development expenses and $ 308,902 was included within general and administrative expenses on the statements of operations) and $ 493,632 ($ 36,197 of which was included within research and development expenses and $ 457,435 of which was included within general and administrative expenses on the statements of operations), respectively. For the six months ended June 30, 2024 and 2023, the Company recorded stock-based compensation expense of $ 1,087,288 ($ 438,740 of which was included within research and development expenses and $ 648,548 of which was included within general and administrative expenses on the statements of operations) and $ 1,312,696 ($ 411,327 of which was included within research and development expenses and $ 901,369 of which was included within general and administrative expenses on the statements of operations), respectively.
Restricted Stock Units
A summary of the restricted stock units (“RSUs”) activity during the six months ended June 30, 2024 is presented below:
Weighted
Average
Number of
Exercise
RSUs
Price
RSUs non-vested January 1, 2024
106,019
$
2.12
Granted
368,886
0.65
Vested
( 106,019 )
2.12
Forfeited
—
—
RSUs non-vested June 30, 2024
368,886
$
0.65
Vested RSUs undelivered June 30, 2024
241,764
$
2.17
To date, RSUs have only been granted to directors in accordance with the Company’s Amended and Restated 2018 Omnibus Stock Incentive Plan. The Company’s policy is not to deliver shares underlying the RSUs until the termination of service.
As of June 30, 2024, there was $ 237,405 of unrecognized stock-based compensation expense related to RSUs which will be recognized over a weighted average period of 0.9 years.
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EYENOVIA, INC.
NOTES TO CONDENSED FINANCIAL STATEMENTS
(UNAUDITED)
Stock Options
A summary of the option activity during the six months ended June 30, 2024 is presented below:
Weighted
Weighted
Average
Average
Remaining
Aggregate
Number of
Exercise
Life
Intrinsic
Options
Price
In Years
Value
Outstanding, January 1, 2024
5,306,377
$
3.31
Granted
1,926,136
1.18
Exercised
—
—
Forfeited
( 633,124 )
3.27
Outstanding, June 30, 2024
6,599,389
$
2.91
7.3
$
26,325
Exercisable, June 30, 2024
4,053,359
$
3.48
6.0
$
—
The following table presents information related to stock options as of June 30, 2024:
Options Outstanding
Options Exercisable
Weighted
Average
Exercise
Number of
Remaining Life
Number of
Price
Options
In Years
Options
$ 0.01 - $ 0.99
1,053,136
—
—
$ 1.00 - $ 1.99
2,263,037
5.6
1,145,297
$ 2.00 - $ 2.99
1,279,099
6.8
1,014,401
$ 3.00 - $ 3.99
819,018
6.1
733,022
$ 4.00 - $ 4.99
303,027
7.2
278,567
$ 5.00 - $ 5.99
35,805
2.9
35,805
$ 6.00 - $ 6.99
695,627
5.5
695,627
$ 7.00 +
150,640
3.8
150,640
6,599,389
6.0
4,053,359
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 Six Months Ended
June 30,
June 30,
2024
2023
2024
2023
Expected term (years)
5.50 - 5.85
5.50 - 10.00
5.50 - 10.00
5.50 - 10.00
Risk free interest rate
4.32 % - 4.72 %
3.44 % - 4.02 %
4.04 % - 4.72 %
3.44 % - 4.18 %
Expected volatility
83 % - 86 %
82 % - 94 %
80 % - 86 %
82 % - 95 %
Expected dividends
0.00 %
0.00 %
0.00 %
0.00 %
As of June 30, 2024, there was $ 2,358,546 of unrecognized stock-based compensation expense related to stock options which will be recognized over a weighted average period of 1.8 years.
The weighted average estimated grant date fair value of the stock options granted for the three months ended June 30, 2024 and 2023 was approximately $ 0.44 and $ 2.04 per share, respectively. The weighted average estimated grant date fair value of the stock options granted for the six months ended June 30, 2024 and 2023 was approximately $ 0.84 and $ 1.78 per share, respectively.
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EYENOVIA, INC.
NOTES TO CONDENSED FINANCIAL STATEMENTS
(UNAUDITED)
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. 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 June 30, 2024 and 2023, the Company recorded expense of $ 61,706 ( $ 43,875 which was included within research and development expenses and $ 17,831 was included within general and administrative expenses on the statements of operations) and $ 46,196 ( $ 35,178 of which was included within research and development expenses and $ 11,018 of which was included within general and administrative expenses on the statements of operations), respectively, associated with its matching contributions. During the six months ended June 30, 2024 and 2023, the Company recorded expense of $ 164,189 ( $ 95,412 of which was included within research and development expenses and $ 68,777 of which was included within general and administrative expenses on the statements of operations) and $ 125,164 ( $ 78,176 of which was included within research and development expenses and $ 46,988 of which was included within general and administrative expenses on the statements of operations) associated with its matching contributions, respectively.
Note 11 - Subsequent Events
Registered Direct Offering
On July 1, 2024, the Company closed on a registered direct offering (the “July Offering”) with certain institutional and accredited investors (the “Investors”), pursuant to which the Company sold 7,575,757 shares of common stock and warrants to purchase up to 7,575,757 shares of common stock. The combined offering price for each share of common stock and accompanying warrant was $ 0.66 . The Company also agreed to issue warrants to purchase an additional 1,749,780 shares of common stock to one of the Investors at an exercise price of $ 0.69 per share. All of the new warrants become exercisable six months following their issuance, and may be exercised until January 2, 2030.
In connection with the July Offering, the Company entered into warrant amendment agreements (the “Amendments”) with the holders of previously issued warrants (the “Prior Warrants”) to purchase up to an aggregate of 10,386,269 shares of common stock, whereby the Company agreed to amend the Prior Warrants to reduce the exercise price of the Prior Warrants from $ 2.23 or $ 2.21 per share of common stock to $ 0.69 per share of common stock, extend the term of the Prior Warrants until January 2, 2030 and prohibit exercise of the Prior Warrants for the six-month period following the effective date of the Amendments.
The aggregate gross proceeds from the July Offering were approximately $ 5.0 million. Total estimated issuance costs are approximately $ 0.7 million.
At-The-Market Offering
Subsequent to June 30, 2024, the Company received approximately $ 0.8 million in gross proceeds from the sale of 665,762 shares of its common stock pursuant to its Sales Agreement with Leerink Partners in its “at-the-market” offering.
16
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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.