What changed in this filing

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Item 1. Financial Statements

2024-11-12 compared with 2024-08-14 · 236 added, 118 removed, 368 unchanged (49% of the section changed)

2 unchanged sentences

Condensed Balance Sheets

September 30,

Current Assets

6 unchanged sentences

Property and equipment, net

Deferred offering costs

Security deposits, non-current

3 unchanged sentences

Equipment deposits

Liabilities and Stockholders’ (Deficiency) Equity

Liabilities and Stockholders’ Equity

Current Liabilities:

3 unchanged sentences

Operating lease liabilities - current portion

Notes payable - current portion, net of debt discount of $ 692,567 and $ 503,914 as of June 30, 2024 and December 31, 2023, respectively

Convertible notes payable - current portion, net of debt discount of $ 18,117 and $ 0 as of June 30, 2024 and December 31, 2023, respectively

Notes payable - current portion, net of debt discount of $ 562,711 and $ 503,914 as of September 30, 2024 and December 31, 2023, respectively

Convertible notes payable - current portion, net of debt discount of $ 72,467 and $ 0 as of September 30, 2024 and December 31, 2023, respectively

Total Current Liabilities

Accrued expenses and other non-current liabilities

Operating lease liabilities - non-current portion

Notes payable - non-current portion, net of debt discount of $ 0 and $ 448,367 as of June 30, 2024 and December 31, 2023, respectively

Convertible notes payable - net of debt discount of $ 271,752 and $ 398,569 as of June 30, 2024 and December 31, 2023, respectively

Notes payable - non-current portion, net of debt discount of $ 0 and $ 448,367 as of September 30, 2024 and December 31, 2023, respectively

Convertible notes payable - non-current portion, net of debt discount of $ 163,051 and $ 398,569 as of September 30, 2024 and December 31, 2023, respectively

Total Liabilities

Commitments and contingencies (Note 8)

Stockholders’ (Deficiency) Equity:

Stockholders’ 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

0 shares issued and outstanding as of September 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

86,375,958 and 45,553,026 shares issued and outstanding as of September 30, 2024 and December 31, 2023, respectively

Additional paid-in capital

2 unchanged sentences

( 145,491,559 )

Total Stockholders' (Deficiency) Equity

( 2,369,903 )

Total Liabilities and Stockholders' (Deficiency) Equity

Total Stockholders’ Equity

Total Liabilities and Stockholders’ Equity

The accompanying notes are an integral part of these condensed financial statements.

2 unchanged sentences

For the Three Months Ended

For the Six Months Ended

For the Nine Months Ended

September 30,

Operating Income

2 unchanged sentences

Research and development

General and administrative

Selling, general and administrative

Reacquisition of license rights

12 unchanged sentences

Interest income

Total Other Income (Expense)

Total Other Expense

( 1,354,067 )

2 unchanged sentences

( 29,863,653 )

( 19,293,959 )

Net Loss Per Share - Basic and Diluted

3 unchanged sentences

Condensed Statements of Changes in Stockholders’ (Deficiency) Equity

For the Three and Six Months Ended June 30, 2024

For the Three and Nine Months Ended September 30, 2024

Stockholders’

2 unchanged sentences

( 145,491,559 )

Issuance of common stock in At the Market offering [1]

Issuance of common stock in At the Market Program [1]

Stock-based compensation

3 unchanged sentences

( 156,413,660 )

Issuance of common stock in registered direct offering [2]

Issuance of common stock in offering [2]

Issuance of common stock as consideration for licensing agreement [3]

Issuance of common stock as consideration for reacquisition of licensing agreement [4]

Issuance of common stock in At the Market offering [5]

Issuance of common stock in At the Market Program [5]

Stock-based compensation

4 unchanged sentences

( 2,369,903 )

Issuance of common stock and warrants in offerings [6]

Warrant modification and additional warrants - incremental value (7)

Warrant modification and additional warrants - in issuance costs for offering (8)

( 2,868,000 )

Issuance of common stock in At the Market Program [9]

Stock-based compensation

( 7,887,853 )

Balance - September 30, 2024

( 175,355,212 )

[1] Includes gross proceeds of $ 3,293,347 less total issuance costs of $ 98,800 .

3 unchanged sentences

[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

[6] Includes gross proceeds of $ 14,139,994 , less total cash issuance costs of $ 1,791,816 .

[7] Offering includes modification of warrants and additional warrants in the July 2024 offering.

[8] Non-cash warrant modification and additional warrants issuance costs related to one of the offerings of $ 2,868,000 are shown on a separate line item.

[9] Includes gross proceeds of $ 1,212,251 less total issuance costs of $ 36,368 .

The accompanying notes are an integral part of these condensed financial statements.

EYENOVIA, INC.

Condensed Statements of Changes in Stockholders’ Equity, continued

For the Three and Nine Months Ended September 30, 2023

Stockholders’

18 unchanged sentences

( 130,185,689 )

Issuance of common stock and warrants in registered direct offering [3][7]

Issuance of common stock as consideration for licensing agreement [4]

Issuance of common stock in At the Market offering [5]

Warrant modification - incremental value (6)

Warrant modification - in issuance costs for registered direct offering (7)

( 1,738,700 )

Stock-based compensation

( 7,338,733 )

Balance - September 30, 2023

( 137,524,422 )

[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.

1 unchanged sentence

Condensed Statements of Cash Flows

For the Six Months Ended

For the Nine Months Ended

September 30,

Cash Flows From Operating Activities

9 unchanged sentences

Write-down of inventories to net realizable value

Provision for returned deferred clinical supplies

Reacquisition of license rights

5 unchanged sentences

( 1,637,756 )

( 1,051,023 )

Security and equipment deposits

9 unchanged sentences

( 2,702,361 )

Investment in intangible asset

( 1,122,945 )

Net Cash Used In Investing Activities

1 unchanged sentence

Cash Flows From Financing Activities

Proceeds from sale of common stock and warrants in registered direct offering

Payment of registered direct offering issuance costs

Proceeds from sale of common stock in At the Market offering

Payment of issuance costs for At the Market offering

Proceeds from sale of common stock and warrants in offerings

Payment of offerings issuance costs

( 1,902,987 )

( 1,091,354 )

Proceeds from sale of common stock in At the Market Program

Payment of issuance costs for At the Market Program

Proceeds from exercise of stock options

Proceeds from note payable and equity issued to Avenue

Proceeds from note payable to Avenue

Payment of issuance costs for notes issued to Avenue

10 unchanged sentences

Condensed Statements of Cash Flows, continued

For the Six Months Ended

For the Nine Months Ended

September 30,

Supplemental Disclosure of Cash Flow Information:

7 unchanged sentences

Original issue discount on notes payable

Warrant modification and additional warrants - incremental value

Issuance of common stock in consideration of licensing agreement

Cashless exercise of stock options

7 unchanged sentences

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.

(“Eyenovia” or the “Company”) is an ophthalmic technology company developing and commercializing advanced products leveraging its proprietary Optejet topical ophthalmic medication dispensing platform.

The Optejet is especially useful in the treatment of chronic front-of-the-eye diseases due to its ease of use, enhanced safety and tolerability, and potential for superior compliance versus standard eye drops.

Together, these benefits may combine to produce better treatment options and outcomes for patients and providers.

The company’s pre-NDA candidate, MicroPine, is being developed for pediatric progressive myopia, a global epidemic impacting hundreds of millions of children worldwide and representing a multi-billion-dollar addressable market.

The company’s current commercial portfolio includes clobetasol propionate ophthalmic suspension, 0.05%, for post-surgical pain and inflammation, and Mydcombi® for mydriasis.

Eyenovia has also secured licensing and development agreements for additional multi-billion-dollar indications where the Optejet may be advantageous, including dry eye.

The accompanying unaudited condensed financial statements have been prepared in accordance with accounting principles generally accepted in the United States of America (“U.S.

2 unchanged sentences

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.

In the opinion of management, such statements include all adjustments (consisting only of normal recurring items) which are considered necessary for a fair presentation of the condensed financial statements of the Company as of September 30, 2024 and for the three and nine months ended September 30, 2024 and 2023.

The results of operations for the three and nine months ended September 30, 2024 are not necessarily indicative of the operating results for the full year ending December 31, 2024 or any other period.

These unaudited condensed financial statements should be read in conjunction with the audited financial statements and related disclosures of the Company as of December 31, 2023 and for the year then ended, which were included in the Company’s Annual Report on Form 10-K for the year ended December 31, 2023, filed with the Securities and Exchange Commission (“SEC”) on March 18, 2024 (the “2023 Form 10-K”), as amended by Amendment No.

2 unchanged sentences

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.

There have been no material changes to the Company’s significant accounting policies during the nine months ended September 30, 2024, except as disclosed below.

Liquidity and Going Concern

As of 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.

As of September 30, 2024, the Company had unrestricted cash and cash equivalents of approximately $ 7.2 million and an accumulated deficit of approximately $ 175.4 million.

For the nine months ended September 30, 2024 and 2023, the Company incurred net losses of approximately $ 29.9 million and $ 19.3 million, respectively, and used cash in operations of approximately $ 24.0 million and $ 17.5 million, respectively.

The Company does not have recurring significant 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.

The Company expects that it will continue to incur significant research and development and selling, general and administrative expenses 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.

1 unchanged sentence

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.

1 unchanged sentence

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.

As of September 30, 2024 and December 31, 2023, the Company had Treasury bills with original maturity dates of three months or less in the amounts of $ 0 and $ 5,450,118 , respectively.

EYENOVIA, INC.

2 unchanged sentences

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.

As of September 30, 2024 and December 31, 2023, the Company had cash and cash equivalent balances in excess of FDIC insurance limits of $ 6,784,903 and $ 14,243,870 , respectively.

Clinical Supply Arrangements

5 unchanged sentences

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.

Deferred clinical supply costs were $ 0.4 million and $ 4.3 million at September 30, 2024 and December 31, 2023, respectively.

See Note 8 – Commitments and Contingencies –Defective Clinical Supply for additional information.

1 unchanged sentence

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 cost of inventory that is sold commercially to third parties is included within cost of sales.

The Company will periodically review for slow-moving, excess or obsolete inventories.

Inventory is primarily comprised of drug-device combination products, which are available for commercial sale, as follows:

September 30,

Finished goods

2 unchanged sentences

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 write-down of commercial inventory to net realizable value for the three months ended September 30, 2024 and 2023 was $ 0.1 million and $ 0.0 million, respectively.

The write-down of commercial inventory for the nine months ended September 30, 2024 and 2023 was $ 0.8 million and $ 0.0 million, respectively.

The write - down for the nine months ended September 30, 2024 consisted of $ 0.2 million of inventory write down adjustments to list price for the first quarter of 2024, $ 0.5 million for the write-down of short dated inventory to net realizable value for the second quarter of 2024 and $ 0.1 million for the write - down of inventory to net realizable value for the third 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.

6 unchanged sentences

For the Three Months Ended

For the Six Months Ended

For the Nine Months Ended

September 30,

Net loss attributable to common stockholders

5 unchanged sentences

Common shares issued

Prefunded warrants

Undelivered vested restricted shares

2 unchanged sentences

The following securities are excluded from the calculation of weighted average diluted shares of common stock because their inclusion would have been anti-dilutive:

September 30,

Convertible notes

18 unchanged sentences

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:

As of September 30, 2024 and December 31, 2023, prepaid expenses and other current assets consisted of the following:

September 30,

Prepaid insurance expenses

Payroll tax receivable

Prepaid research and development expenses

Prepaid conference expenses

Prepaid general and administrative expenses

Prepaid patent expenses

Prepaid conference expenses

Prepaid research and development expenses

Prepaid rent and security deposit

Prepaid professional fees

Prepaid board of directors fees

Total prepaid expenses and other current assets

Note 4 - Intangible Assets

On August 15, 2023 (the “Effective Date”), the Company entered into a license agreement (the “License”) with Formosa Pharmaceuticals Inc.

On August 15, 2023, the Company entered into a license agreement (the “Formosa License”) with Formosa Pharmaceuticals Inc.

(“Formosa”), whereby the Company acquired the exclusive U.S.

rights to commercialize any product related to a novel formulation of clobetasol propionate ophthalmic suspension, 0.05 % (the “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.

rights to commercialize any product related to a novel formulation of clobetasol propionate ophthalmic suspension, 0.05 % (the “Formosa Licensed Product”), which was approved by the FDA for ophthalmic use for inflammation and pain after ocular surgery and supplemental disease indications, if any, associated with the New Drug Application for the Formosa Licensed Product.

The Formosa License will remain in effect for ten years from the date of the first commercial sale of a Formosa Licensed Product, unless earlier terminated.

The Company paid Formosa the aggregate amount of $ 2.0 million (the “Upfront Payment”), consisting of (a) cash in the amount of $ 1.0 million and (b) 487,805 shares of common stock, which is included in Intangible Assets on the accompanying balance sheet.

1 unchanged sentence

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.

The trigger for the initial $ 2.0 million development milestone payments was FDA approval of the Formosa Licensed Product and the effective date of the acceptance by the Company of the transfer and assignment of the FDA approval.

This occurred on March 14, 2024.

Under the provisions of the 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.

Under the provisions of the Formosa License, the Company had 45 days from the effective date of acceptance of the transfer and assignment of FDA approval to make the payment half in cash and half in common stock, otherwise the payment due would revert to be fully in cash.

The Company paid Formosa the aggregate amount of $ 2.0 million, consisting of (a) cash in the amount of $ 1.0 million on April 26, 2024 and (b) 613,496 shares of common stock on April 29, 2024 (calculated pursuant to the Formosa License using a five-day volume-weighted average price on March 14, 2024, but valued at $ 0.4 million on the April 29, 2024 settlement date, resulting in a $ 0.6 million change in fair value of the equity consideration payable), which is included in Intangible Assets on the accompanying balance sheet as of September 30, 2024.

The second $ 2.0 million development milestone (to be fully paid in cash) was earned upon FDA approval of the Formosa Licensed Product and payment was triggered on the earlier of twelve months after FDA approval or six months following the first commercial sale of the Formosa Licensed Product.

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.

2 unchanged sentences

Note 5 – Accrued Compensation

As of June 30, 2024 and December 31, 2023, accrued compensation consisted of the following:

As of September 30, 2024 and December 31, 2023, accrued compensation consisted of the following:

September 30,

Accrued bonus expenses

2 unchanged sentences

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:

As of September 30, 2024 and December 31, 2023, accrued expenses and other current liabilities consisted of the following:

September 30,

Accrued intangible asset milestone obligation

Accrued defective clinical supply settlement, net

Accrued research and development expenses

Accrued clinical studies costs

Accrued professional services

1 unchanged sentence

Accrued franchise tax

Accrued research and development expenses

Total accrued expenses and other current liabilities

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

As of September 30, 2024 and December 31, 2023, notes payable and convertible notes payable consisted of the following:

September 30, 2024

December 31, 2023

13 unchanged sentences

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.

The note accrued interest at a rate of 8.15 % per year and matured on October 24, 2024.

The D&O Loan was payable in eight monthly payments of $ 65,076 consisting of principal and interest.

During the nine months ended September 30, 2024, the Company repaid $ 440,413 of principal owed on the D&O Loan.

The note was paid off in full on the maturity date.

EYENOVIA, INC.

NOTES TO CONDENSED FINANCIAL STATEMENTS

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.

In June 2024, the Company began making principal payments related to that certain loan and security agreement (the “Loan and Security Agreement”) with Avenue Capital Management II, L.P.

and related entities (together, “Avenue”) in the amount of $ 833,333 per month plus interest.

During the three months ended September 30, 2024, the Company recorded interest expense of $ 602,109 , of which $ 598,188 (including amortization of debt discount of $ 184,207 ) was related to the Avenue loan and $ 3,921 was related to the D&O Loan.

During the nine months ended September 30, 2024, the Company recorded interest expense of $ 1,954,768 , of which $ 1,939,650 was related to the Loan and Security Agreement (including amortization of debt discount of $ 552,620 ) and $ 15,118 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.

During the third quarter of 2023, a certain portion of clinical supply product sold by the Company to Bausch + Lomb was determined to be defective.

On April 23, 2024, the Company and Bausch + Lomb executed a letter agreement (the “Side Letter”) pursuant to which the Company and Bausch + Lomb agreed that the Company would pay approximately $ 0.5 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).

During the three and nine months ended September 30, 2024, the Company recorded no additional charge and a $ 0.1 million charge, respectively, to other income (expense).

Bausch License Agreements

6 unchanged sentences

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.

The Company recorded this amount as an operating expense.

In connection with the entry into the Letter Agreement, the Company also agreed to issue Bausch + Lomb $ 3.0 million in shares of the Company’s common stock, following the Regulatory Transfer Date (the “Transfer Date”).

2 unchanged sentences

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.

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.

EYENOVIA, INC.

NOTES TO CONDENSED FINANCIAL STATEMENTS

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.

Operating Leases

A summary of the Company’s right-of-use assets and liabilities is as follows:

For the Six Months Ended June 30,

For the Nine Months Ended September 30,

Cash paid for amounts included in the measurement of lease liabilities:

17 unchanged sentences

The Company records legal costs associated with loss contingencies as incurred and accrues for all probable and estimable settlements.

Note 9 – Stockholders’ (Deficiency) Equity

Note 9 – Related Party Transactions

The Company has an advisory service agreement with a member of the board of directors.

The agreement calls for a monthly consulting fee of $ 5,000 , paid on a quarterly basis, which is in addition to the compensation paid to the individual pursuant to the Company’s non - employee director compensation policy while such individual remains a member of the board of directors.

EYENOVIA, INC.

NOTES TO CONDENSED FINANCIAL STATEMENTS

Note 10 – Stockholders’ Equity

Increase in Authorized Number of Shares of Common Stock

On June 12, 2024, at the Annual Shareholders’ Meeting, the Company proposed and the shareholders approved an increase in 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.

On June 12, 2024, at the Annual Shareholders’ Meeting, the Company proposed and the shareholders approved an increase in the authorized number of shares of the Company’s common stock from 90,000,000 to 300,000,000 at the same par value of $ 0.0001 per share.

Common Stock Issuances

1 unchanged sentence

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).

At-The-Market Program

During the nine months ended September 30, 2024, the Company received approximately $ 6.0 million in net proceeds from the sale of 5,630,556 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.

Second Quarter Offering

On April 8, 2024, the Company entered into a securities purchase agreement (the “Purchase Agreement”) with a single fundamentals-based healthcare investor (the “Purchaser”), pursuant to which the Company agreed to sell, in a registered direct offering by the Company directly to the Purchaser (the “April Offering”), 3,223,726 shares of common stock.

The price per share in the April Offering was $ 0.6204 .

The aggregate gross proceeds to the Company from the April Offering were $ 2.0 million, and net proceeds after offering costs were approximately $ 1.9 million.

Third Quarter Offerings

A summary of the offerings for the third quarter is presented below:

Stockholders’

July Offering

August Offering

September Offering

July Offering and Warrant Amendment

On July 1, 2024, the Company closed on a registered direct offering (the “July Offering”) with certain institutional and accredited investors (the “July Investors”), pursuant to which the Company sold 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 (the “Additional Warrants”) to one of the July Investors.

All of the new warrants become exercisable six months following their issuance, at an exercise price of $ 0.69 per share, and may be exercised until January 2, 2030.

EYENOVIA, INC.

NOTES TO CONDENSED FINANCIAL STATEMENTS

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.

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 and $ 2.47 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 to the Company from the July Offering were approximately $ 5.0 million, and net proceeds after cash offering costs were approximately $ 4.3 million.

Offering costs include placement agent fees of $ 0.4 million and Company legal fees of $ 0.3 million.

In addition, there were $ 2.9 million of non-cash issuance costs which represents the value of the Additional Warrants, plus the modification date incremental value of the modified Prior Warrants as compared to the original Prior Warrants, as an issuance cost of the warrant exercise.

August Offering

On August 21, 2024, the Company agreed to sell 12,850,000 shares of common stock to certain institutional and accredited investors (the “August Investors”), in some cases pursuant to a securities purchase agreement (the “August Offering”).

The price per share in the August Offering was $ 0.40 .

The aggregate gross proceeds to the Company from the August Offering were approximately $ 5.1 million, and net proceeds after offering costs were approximately $ 4.5 million.

September Offering

On September 30, 2024, the Company closed on a registered direct offering (the “September Offering”) with a certain purchaser, pursuant to which the Company sold to the purchaser 8,630,000 shares of common stock;

pre-funded warrants to purchase up to 65,653 shares of common stock;

and warrants to purchase up to 8,695,653 shares of common stock at an exercise price of $ 0.50 per share.

The combined offering price for each share and accompanying warrant was $ 0.46 .

The combined offering price for each pre-funded warrant and accompanying Warrant was $ 0.4599 , which is equal to the purchase price per share in the September Offering, minus $ 0.0001 , the exercise price per share of the pre-funded warrants.

The warrants will be exercisable beginning six months following the date of issuance and may be exercised until March 31, 2030.

The aggregate gross proceeds to the Company from the September Offering were approximately $ 4.0 million, and net proceeds after offering costs were approximately $ 3.6 million.

The issuance date or modification date fair value of stock warrants issued or modified during the three and nine months ended September 30, 2024 and 2023 was determined using the Black Scholes method, with the following assumptions used:

For the Three Months Ended

For the Nine Months Ended

September 30,

Fair value of common stock on date of grant

Risk free interest rate

4.39 % - 5.22 %

Expected term (years)

0.7 - 5.5 years

4.0 - 5.5 years

0.7 - 5.5 years

4.0 - 5.5 years

Expected volatility

Expected dividends

EYENOVIA, INC.

NOTES TO CONDENSED FINANCIAL STATEMENTS

A summary of the warrant activity during the nine months ended September 30, 2024 is presented below:

Outstanding January 1, 2024

Repriced - (Old) (2)

( 10,386,269 )

Repriced - (New) (2)

Outstanding September 30, 2024 (1)

Exercisable September 30, 2024 (1)

(1) - Warrants granted, outstanding and exercisable exclude 65,653 pre-funded warrants with an exercise price of $ 0.0001 .

(2) - Repriced warrants represent the reset of the exercise price of certain warrants to purchase 10,386,269 shares of common stock to a price of $ 0.69 per share.

The following table presents information related to warrants as of September 30, 2024:

Warrants Outstanding (1)

Warants Exercisable (1)

Remaining Life

(1) - Warrants outstanding and exercisable exclude 65,653 Pre-Funded Warrants with an exercise price of $ 0.0001 .

(2) - These warrants become exercisable on March 26, 2025.

(3) - These warrants become exercisable on January 1, 2025.

Stock-Based Compensation Expense

The Company records stock-based compensation expense related to stock options and restricted stock units (“RSUs”).

For the three months ended 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.

For the three months ended September 30, 2024 and 2023, the Company recorded stock-based compensation expense of $ 452,998 ($ 179,776 of which was included within research and development expenses and $ 273,222 was included within selling, general and administrative expenses on the statements of operations) and $ 612,969 ($ 235,731 of which was included within research and development expenses and $ 377,238 of which was included within selling, general and administrative expenses on the statements of operations), respectively.

For the nine months ended September 30, 2024 and 2023, the Company recorded stock-based compensation expense of $ 1,540,286 ($ 618,516 of which was included within research and development expenses and $ 921,770 of which was included within selling, general and administrative expenses on the statements of operations) and $ 1,925,665 ($ 647,058 of which was included within research and development expenses and $ 1,278,607 of which was included within selling, general and administrative expenses on the statements of operations), respectively.

EYENOVIA, INC.

NOTES TO CONDENSED FINANCIAL STATEMENTS

Restricted Stock Units

A summary of the restricted stock units (“RSUs”) activity during the six months ended June 30, 2024 is presented below:

A summary of the restricted stock units (“RSUs”) activity during the nine months ended September 30, 2024 is presented below:

RSUs non-vested January 1, 2024

RSUs non-vested June 30, 2024

Vested RSUs undelivered June 30, 2024

RSUs non-vested September 30, 2024

Vested RSUs undelivered September 30, 2024

To date, RSUs have only been granted to directors in accordance with the Company’s Amended and Restated 2018 Omnibus Stock Incentive Plan.

The Company’s policy is not to deliver shares underlying the RSUs until 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.

EYENOVIA, INC.

NOTES TO CONDENSED FINANCIAL STATEMENTS

The Company’s policy is not to deliver shares underlying the RSUs until a director’s termination of service.

As of September 30, 2024, there was $ 169,739 of unrecognized stock-based compensation expense related to RSUs which will be recognized over a weighted average period of 0.7 years.

Stock Options

A summary of the option activity during the six months ended June 30, 2024 is presented below:

A summary of the option activity during the nine months ended September 30, 2024 is presented below:

Outstanding, January 1, 2024

Outstanding, June 30, 2024

Exercisable, June 30, 2024

The following table presents information related to stock options as of June 30, 2024:

Forfeited/Expired

Outstanding, September 30, 2024

Exercisable, September 30, 2024

The following table presents information related to stock options as of September 30, 2024:

Options Outstanding

8 unchanged sentences

$ 6.00 - $ 6.99

EYENOVIA, INC.

NOTES TO CONDENSED FINANCIAL STATEMENTS

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

For the Nine Months Ended

September 30,

Expected term (years)

3 unchanged sentences

3.44 % - 4.18 %

Expected volatility

Expected dividends

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.

EYENOVIA, INC.

NOTES TO CONDENSED FINANCIAL STATEMENTS

As of September 30, 2024, there was $ 2,042,227 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 September 30, 2024 was approximately $ 0.40 per share.

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 nine months ended September 30, 2024 and 2023 was approximately $ 0.79 and $ 1.70 per share, respectively.

Note 11 – Employee Benefit Plans

3 unchanged sentences

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.

During the three months ended September 30, 2024 and 2023, the Company recorded expense of $ 56,493 ( $ 41,186 which was included within research and development expenses and $ 15,307 was included within selling, general and administrative expenses on the statements of operations) and $ 46,636 ( $ 37,383 of which was included within research and development expenses and $ 9,253 of which was included within selling, general and administrative expenses on the statements of operations), respectively, associated with its matching contributions.

During the nine months ended September 30, 2024 and 2023, the Company recorded expense of $ 220,682 ( $ 136,598 of which was included within research and development expenses and $ 84,084 of which was included within selling, general and administrative expenses on the statements of operations) and $ 171,800 ( $ 115,559 of which was included within research and development expenses and $ 56,241 of which was included within selling, general and administrative expenses on the statements of operations) associated with its matching contributions, respectively.

Note 12 - 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.

Exercise of Pre-Funded Warrants

On October 1, 2024, the holder of the 65,653 pre-funded warrants issued in the September Offering, exercised the pre-funded warrants at a price of $ 0.0001 per share of common stock (see Note 10 - Stockholders’ Equity - Offerings).

Compared sentence by sentence after normalising whitespace, quotation marks, case and digits, so re-formatting and restated figures do not read as changed language. Wording changes appear as one removal and one addition. The current filing and the prior one are authoritative.

What changed 10-Q

Item 1. Financial Statements