2 unchanged sentences
Condensed Balance Sheets
−Removed: September 30,
Current Assets
16 unchanged sentences
Operating lease liabilities - current portion
−Removed: Notes payable - current portion, net of debt discount of $ 327,217 and $ 33,885 as of September 30, 2023 and December 31, 2022, respectively
−Removed: Convertible notes payable - current portion, net of debt discount of $ 0 and $ 33,885 as of September 30, 2023 and December 31, 2022, respectively
+Added: Notes payable - current portion, net of debt discount of $ 621,712 and $ 503,914 as of March 31, 2024 and December 31, 2023, respectively
Total Current Liabilities
Operating lease liabilities - non-current portion
−Removed: Notes payable - non-current portion, net of debt discount of $ 754,919 and $ 813,229 as of September 30, 2023 and December 31, 2022, respectively
−Removed: Convertible notes payable - non-current portion, net of debt discount of $ 452,920 and $ 813,229 as of September 30, 2023 and December 31, 2022, respectively
+Added: Notes payable - non-current portion, net of debt discount of $ 200,711 and $ 448,367 as of March 31, 2024 and December 31, 2023, respectively
+Added: Convertible notes payable - net of debt discount of $ 344,219 and $ 398,569 as of March 31, 2024 and December 31, 2023, respectively
Total Liabilities
2 unchanged sentences
Preferred stock, $ 0.0001 par value, 6,000,000 shares authorized;
−Removed: 0 shares issued and outstanding as of September 30, 2023 and December 31, 2022
+Added: 0 shares issued and outstanding as of March 31, 2024 and December 31, 2023
Common stock, $ 0.0001 par value, 90,000,000 shares authorized;
−Removed: 42,898,246 and 36,668,980 shares issued and outstanding as of September 30, 2023 and December 31, 2022, respectively
+Added: 47,386,349 and 45,553,026 shares issued and outstanding as of March 31, 2024 and December 31, 2023, respectively
Additional paid-in capital
8 unchanged sentences
For the Three Months Ended
−Removed: For the Nine Months Ended
−Removed: September 30,
−Removed: September 30,
Operating Income
3 unchanged sentences
General and administrative
+Added: Reacquisition of license rights
Total Operating Expenses
2 unchanged sentences
( 5,458,836 )
−Removed: ( 17,939,892 )
−Removed: ( 21,539,233 )
Other Income (Expense):
1 unchanged sentence
Interest expense
−Removed: ( 1,691,228 )
Interest income
2 unchanged sentences
( 5,739,366 )
−Removed: ( 7,308,996 )
−Removed: ( 19,293,959 )
−Removed: ( 21,887,761 )
Net Loss Per Share - Basic and Diluted
3 unchanged sentences
Condensed Statements of Changes in Stockholders’ Equity
−Removed: For the Three and Nine Months Ended September 30, 2023
+Added: For the Three Months Ended March 31, 2024
Stockholders’
2 unchanged sentences
Issuance of common stock in At the Market offering [1]
−Removed: Cashless exercise of stock options
Stock-based compensation
−Removed: Issuance of common stock related to vested restricted stock units
( 10,922,101 )
2 unchanged sentences
( 156,413,660 )
−Removed: Issuance of common stock in At the Market offering [2]
−Removed: Cashless exercise of stock options
−Removed: Exercise of stock options
−Removed: Stock-based compensation
−Removed: Issuance of common stock related to vested restricted stock units
−Removed: ( 6,215,860 )
−Removed: ( 6,215,860 )
−Removed: Balance - June 30, 2023
−Removed: ( 130,185,689 )
−Removed: Issuance of common stock and warrants in registered direct offering [3][7]
−Removed: Issuance of common stock as consideration for licensing agreement [4]
−Removed: Issuance of common stock in At the Market offering [5]
−Removed: Warrant modification - incremental value (6)
−Removed: Warrant modification - in issuance costs for registered direct offering (7)
−Removed: ( 1,738,700 )
−Removed: ( 1,738,700 )
−Removed: Stock-based compensation
−Removed: ( 7,338,733 )
−Removed: ( 7,338,733 )
−Removed: Balance - September 30, 2023
−Removed: ( 137,524,422 )
−Removed: Includes gross proceeds of $ 3,607,827 less total issuance costs of $ 108,235 .
−Removed: Includes gross proceeds of $ 415,588 less total issuance costs of $ 12,468 .
−Removed: Includes gross proceeds of $ 11,977,468 less total cash issuance costs of $ 1,091,354 .
−Removed: Shares issued as partial consideration for License Agreement with Formosa Pharmaceuticals Inc.
−Removed: Includes gross proceeds of $ 100,449 less total issuance costs of $ 3,013 .
−Removed: Registered direct offering included modification of warrant originally granted in the March 2022 offering.
−Removed: [7] Non-cash warrant modification issuance costs related to the registered direct offering of $ 1,738,700 are shown on a separate line item.
−Removed: The accompanying notes are an integral part of these condensed financial statements.
−Removed: EYENOVIA, INC.
−Removed: Condensed Statements of Changes in Stockholders’ Equity
−Removed: For the Three and Nine Months Ended September 30, 2022
+Added: For the Three Months Ended March 31, 2023
Stockholders’
1 unchanged sentence
( 118,230,463 )
−Removed: Issuance of common stock and warrants in registered direct offering [1]
Issuance of common stock in At the Market offering [2]
+Added: Cashless exercise of stock options
Stock-based compensation
4 unchanged sentences
( 123,969,829 )
−Removed: Exercise of stock warrants
−Removed: Stock-based compensation
−Removed: Issuance of common stock related to vested restricted stock units
−Removed: ( 7,239,100 )
−Removed: ( 7,239,100 )
−Removed: Balance - June 30, 2022
−Removed: ( 104,798,071 )
−Removed: Issuance of common stock in At the Market offering [3]
−Removed: Stock-based compensation
−Removed: Issuance of common stock related to vested restricted stock units
−Removed: ( 7,308,996 )
−Removed: ( 7,308,996 )
−Removed: Balance - September 30, 2022
−Removed: ( 112,107,067 )
Includes gross proceeds of $ 3,293,347 less total issuance costs of $ 98,800 .
Includes gross proceeds of $ 3,607,827 less total issuance costs of $ 108,235 .
−Removed: Includes gross proceeds of $ 3,194,530 , less total issuance costs of $ 95,836 .
The accompanying notes are an integral part of these condensed financial statements.
1 unchanged sentence
Condensed Statements of Cash Flows
−Removed: For the Nine Months Ended
−Removed: September 30,
+Added: For the Three Months Ended
Cash Flows From Operating Activities
7 unchanged sentences
Write-down of inventories to net realizable value
−Removed: Provision for returned deferred clinical supplies
+Added: Provision for defective clinical supply settlement
Non-cash rent expense
4 unchanged sentences
( 1,067,714 )
−Removed: ( 1,871,096 )
−Removed: Security and equipment deposits
Accounts payable
Accrued compensation
+Added: ( 1,110,002 )
Accrued expenses and other current liabilities
5 unchanged sentences
Purchases of property and equipment
−Removed: ( 2,702,361 )
Vendor deposits for property and equipment
−Removed: Investment in intangible asset
−Removed: ( 1,122,945 )
Net Cash Used In Investing Activities
−Removed: ( 3,825,306 )
Cash Flows From Financing Activities
−Removed: Proceeds from sale of common stock and warrants in direct offering [1][2]
−Removed: Payment of offering issuance costs
−Removed: ( 1,091,354 )
Proceeds from sale of common stock in At the Market offering
Payment of issuance costs for At the Market offering
−Removed: Proceeds from exercise of stock options
−Removed: Proceeds from note payable to Avenue
−Removed: Payment of issuance costs for notes issued to Avenue
Repayments of notes payable
3 unchanged sentences
( 4,397,198 )
−Removed: Cash, cash equivalents and restricted cash - Beginning of Period
−Removed: Cash, cash equivalents and restricted cash - End of Period
+Added: Cash and Cash Equivalents - Beginning of Period
+Added: Cash and Cash Equivalents - End of Period
The accompanying notes are an integral part of these condensed financial statements.
1 unchanged sentence
Condensed Statements of Cash Flows, continued
−Removed: For the Nine Months Ended
−Removed: September 30,
−Removed: Cash, cash equivalents and restricted cash consisted of the following:
−Removed: Cash and cash equivalents
−Removed: Restricted cash
+Added: For the Three Months Ended
Supplemental Disclosure of Cash Flow Information:
−Removed: Cash paid during the year for:
+Added: Cash paid during the period for:
Supplemental Disclosure of Non-Cash Investing and Financing Activities
Purchase of insurance policy financed by note payable
−Removed: Right-of-use assets and lease liabilities recognized upon lease renewal
−Removed: Vendor deposits applied to purchases of property and equipment
−Removed: Original issue discount on notes payable
−Removed: Warrant modification - incremental value
−Removed: Issuance of common stock in consideration of licensing agreement
+Added: Accrual for intangible asset milestone obligations
+Added: Reclassification of deferred clinical supply costs to inventories
+Added: Right-of-use assets obtained in exchange for lease liabilities
Cashless exercise of stock options
−Removed: Issuance of common stock related to vested restricted stock units
−Removed: [1] For 2022, includes gross proceeds of $ 14,981,299 , of which $ 5,741,299 is pre-funded warrants.
−Removed: [2] For 2023, includes gross proceeds of $ 11,977,468 , of which $ 4,168,011 is pre-funded warrants.
The accompanying notes are an integral part of these condensed financial statements.
3 unchanged sentences
Eyenovia, Inc.
−Removed: (“Eyenovia” or the “Company”) is an ophthalmic technology company developing the Optejet® delivery system for use both in combination with its own drug-device therapeutic programs in mydriasis (pupil dilation), presbyopia and pediatric progressive myopia as well as out-licensing for additional indications.
−Removed: The Company’s investigational products are classified by the Food and Drug Administration (“FDA”) as drug-device combination products with drug primary mode of action, meaning that the Center for Drug Evaluation and Research (“CDER”), is designated as the lead center with primary jurisdictional oversight.
−Removed: Accordingly, the product candidates are submitted to the FDA and CDER for premarket review and approval under new drug applications (“NDAs”).
+Added: (“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.
+Added: 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.
+Added: In the United States, Eyenovia is also focused on the commercialization of its two Food and Drug Administration (“FDA”)-approved products:
+Added: Mydcombi (tropicamide+phenylephrine ophthalmic spray) for mydriasis, as well as clobetasol propionate ophthalmic nanosuspension 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.
2 unchanged sentences
GAAP for complete financial statements.
−Removed: In the opinion of management, such statements include all adjustments (consisting only of normal recurring items) which are considered necessary for a fair presentation of the condensed financial statements of the Company as of September 30, 2023 and for the three and nine months ended September 30, 2023 and 2022.
−Removed: The results of operations for the nine months ended September 30, 2023 are not necessarily indicative of the operating results for the full year ending December 31, 2023 or any other period.
+Added: 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 March 31, 2024 and for the three months ended March 31, 2024 and 2023.
+Added: The results of operations for the three months ended March 31, 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.
−Removed: 1, filed with the SEC on May 1, 2023 (the “2022 Form 10-K Amendment”).
−Removed: Note 2 – Going Concern and Summary of Significant Accounting Policies
−Removed: Since the date of the 2022 Form 10-K, there have been no material changes to the Company’s significant accounting policies, except as disclosed below.
−Removed: Going Concern
−Removed: As of September 30, 2023, the Company had cash and cash equivalents in the aggregate amount of approximately $ 20.7 million.
−Removed: For the nine months ended September 30, 2023 and 2022, the Company incurred net losses of approximately $ 19.3 million and $ 21.9 million, respectively, and used cash in operations of approximately $ 17.5 million and $ 19.7 million, respectively.
−Removed: The Company does not have material recurring revenue, has not yet achieved profitability and may never become profitable.
−Removed: The Company expects to continue to incur cash outflows from operations.
−Removed: Research and development and general and administrative expenses will continue to be incurred by the Company and, as a result, the Company will eventually need to generate significant product revenues to achieve profitability.
−Removed: These circumstances raise substantial doubt about the Company’s ability to continue as a going concern for at least one year from the date that these financial statements were issued.
−Removed: Implementation of the Company’s plans and its ability to continue as a going concern will depend upon the Company’s ability to raise further capital through licensing transactions, the sale of additional equity or debt securities, or otherwise, to support its future operations.
−Removed: The Company’s operating needs include the planned costs to operate its business, including amounts required to fund working capital and capital expenditures.
−Removed: The Company’s future capital requirements and the adequacy of its available funds will depend on many factors, including the Company’s ability to successfully commercialize its products and services, competing technological and market developments, and the need to enter into collaborations with other companies or acquire other companies or technologies to enhance or complement its product and service offerings.
−Removed: If the Company is unable to secure additional capital, it may be required to curtail its research and development initiatives and/or take additional measures to reduce general and administrative and sales and marketing costs in order to conserve its cash.
+Added: 1, filed with the SEC on April 26, 2024 (the “2023 Form 10-K Amendment”).
+Added: Note 2 – Summary of Significant Accounting Policies
+Added: The Company disclosed its significant accounting policies in Note 2 – Summary of Significant Accounting Policies included in the 2023 Form 10-K.
+Added: There have been no material changes to the Company’s significant accounting policies during the three months ended March 31, 2024, except as disclosed below.
+Added: Liquidity and Going Concern
+Added: As of March 31, 2024, the Company had unrestricted cash and cash equivalents of approximately $ 8.0 million and an accumulated deficit of approximately $ 156.4 million.
+Added: For the three months ended March 31, 2024 and 2023, the Company incurred net losses of approximately $ 10.9 million and $ 5.7 million, respectively, and used cash in operations of approximately $ 9.9 million and $ 7.0 million, respectively.
+Added: The Company does not have recurring revenue and has not yet achieved profitability.
+Added: The Company expects to continue to incur cash outflows from operations for the near future.
+Added: 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.
+Added: 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.
+Added: 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.
+Added: Additionally, the Company may need to raise further capital, through the sale of additional equity or debt securities.
+Added: 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
−Removed: The Company considers all highly liquid investments with an original maturity of three months or less to be cash equivalents in the financial statements.As of September 30, 2023, the Company had Treasury bills with original maturity dates of three months or less in the amount of $ 5,221,319 .
+Added: The Company considers all highly liquid investments with an original maturity of three months or less to be cash equivalents in the financial statements.
+Added: As of March 31, 2024 and December 31, 2023, the Company had Treasury bills with original maturity dates of three months or less in the amounts of $ 2,039,357 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.
−Removed: As of September 30, 2023 and December 31, 2022, the Company had cash balances in excess of FDIC insurance limits of $ 15,056,184 and $ 22,613,520 , respectively.
−Removed: Net Loss Per Common Share
−Removed: Basic net loss per common share is computed by dividing net loss by the weighted average number of common shares outstanding during the period plus fully vested shares that are subject to issuance for little or no monetary consideration.
−Removed: Diluted earnings per share reflects the potential dilution that could occur if securities or other instruments to issue common stock were exercised or converted into common stock.
+Added: As of March 31, 2024 and December 31, 2023, the Company had cash and cash equivalent balances in excess of FDIC insurance limits of $ 7,301,681 and $ 14,243,870 , respectively.
+Added: Clinical Supply Arrangements
+Added: 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.
+Added: 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.
+Added: The arrangement with Arctic Vision is still in place.
+Added: 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.
+Added: 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;
+Added: and (b) report the net income from the clinical supply arrangements as other income.
+Added: Deferred clinical supply costs were $ 0.8 million and $ 4.3 million at March 31, 2024 and December 31, 2023, respectively.
+Added: See Note 8 – Commitments and Contingencies –Defective Clinical Supply for additional information.
+Added: Inventories are stated at the lower of cost or net realizable value.
+Added: Cost is determined using the first-in, first-out method.
+Added: The cost of inventory that is sold to third parties is included within cost of sales.
+Added: The Company will periodically review for slow-moving, excess or obsolete inventories.
+Added: Inventory is primarily comprised of drug-device combination products, which are available for commercial sale, as follows:
+Added: Finished goods
+Added: Raw materials
+Added: Total inventory
+Added: The Company has evaluated the net realizable value of the commercial inventory.
+Added: The write-down of commercial inventory to net realizable value was $ 198,034 and $ 0 for the three months ended March 31, 2024 and 2023, respectively.
+Added: EYENOVIA, INC.
+Added: NOTES TO CONDENSED FINANCIAL STATEMENTS
+Added: Net Loss Per Share of Common Stock
+Added: 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.
+Added: 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
−Removed: For the Nine Months Ended
−Removed: September 30,
−Removed: September 30,
−Removed: Net loss attributable to common stockholders
+Added: Net income (loss)
( 10,922,101 )
( 5,739,366 )
+Added: Net loss attributable to common stockholders
( 10,922,101 )
2 unchanged sentences
Common shares issued
−Removed: Prefunded warrants
−Removed: Undelivered vested restricted shares
+Added: Undelivered vested restricted stock units
Denominator for basic and diluted net loss per share
Basic and diluted net loss per common share
−Removed: The following securities are excluded from the calculation of weighted average diluted common shares because their inclusion would have been anti-dilutive:
−Removed: September 30,
+Added: The following securities are excluded from the calculation of weighted average diluted shares of common stock because their inclusion would have been anti-dilutive:
Convertible notes
1 unchanged sentence
Total potentially dilutive shares
−Removed: Clinical Supply Arrangements
−Removed: Bausch + Lomb, Inc.
−Removed: (“B+L”) and Arctic Vision (Hong Kong) Limited (“Arctic Vision”) have contracted with the Company to manufacture and supply them with the appropriate drug-device combination products to conduct their clinical trials on a cost plus 10 % mark-up basis.
−Removed: The Company’s licensing agreements with Bausch + Lomb and Arctic Vision represent collaborative arrangements and they are not customers with respect to the clinical supply arrangements.
−Removed: 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;
−Removed: and (b) to report the net income from the clinical supply arrangements as other income.
−Removed: EYENOVIA, INC.
−Removed: NOTES TO CONDENSED FINANCIAL STATEMENTS
−Removed: Inventories are stated at the lower of cost or net realizable value.
−Removed: Cost is determined using the first-in, first-out method.
−Removed: The cost of inventory that is sold to third parties is included within cost of sales.
−Removed: The Company will periodically review for slow-moving, excess or obsolete inventories.
−Removed: Inventory is primarily comprised of drug-device combination products, which are available for commercial sale, as follows:
−Removed: September 30,
−Removed: Finished goods
−Removed: Work-in-process
−Removed: Raw materials
−Removed: Total inventory
−Removed: Intangible Assets
−Removed: The application of the guidance in ASC 805 (“Business Combinations”) on accounting for business combinations can differ significantly depending on whether the acquired entity is considered a “business” or an “asset.” A determination of whether the transaction represented an asset acquisition or a business combination must be made.
−Removed: Pursuant to ASC 350 (“Intangibles - Goodwill and Other”), the payment made for the intangible asset will be capitalized and amortized over the useful life of the intangible asset.
−Removed: On August 15, 2023 (the “Effective Date”), the Company entered into a license agreement (the “License”) with Formosa Pharmaceuticals Inc.
−Removed: (the “Licensor”), whereby the Company acquired the exclusive U.S.
−Removed: rights to commercialize any product related to a novel formulation of clobetasol propionate ophthalmic nanosuspension, 0.05 % (the “Licensed Product”), which is currently under review by the FDA for ophthalmic use for inflammation and pain after ocular surgery and supplemental disease indications, if any, associated with the New Drug Application for the Licensed Product.
−Removed: The License will remain in effect for ten years from the date of the first commercial sale of a Licensed Product, unless earlier terminated.
−Removed: The Company paid the Licensor the aggregate amount of $ 2,000,000 (the “Upfront Payment”), consisting of (a) cash in the amount of $ 1,000,000 and (b) 487,805 shares of common stock valued at $ 1,000,000 , which is included in Intangible Assets on the accompanying condensed balance sheet.
−Removed: In addition to the Upfront Payment, the Company also capitalized $ 122,945 of transaction costs, which were primarily legal expenses.
−Removed: In addition, the Company must pay the Licensor up to $ 4 million upon the achievement of certain development milestones and up to $ 80 million upon the achievement of certain sales milestones.
−Removed: The initial trigger for development milestone payments is FDA approval of the Licensed Product.
−Removed: These contingent payments will be recorded when payment becomes probable and estimable.
−Removed: It was determined that the transaction represented an asset acquisition, rather than a business combination, because substantially all of the fair value of the assets acquired is concentrated in a single identifiable asset.
−Removed: Consequently, the accounting is pursuant to the cost accumulation model.
−Removed: The Upfront Payment has been capitalized as an intangible asset by the Company, and will be amortized over the useful life of 10 years beginning on the date of the first commercial sale of the Licensed Product.
−Removed: Recently Adopted Accounting Standards
−Removed: In June 2016, the FASB issued ASU No.
−Removed: 2016-13, “Financial Instruments - Credit Losses (Topic 326)” and also issued subsequent amendments to the initial guidance under ASU 2018-19, ASU 2019-04 and ASU 2019-05 (collectively, “Topic 326”).
−Removed: Topic 326 requires the measurement and recognition of expected credit losses for financial assets held at amortized cost.
−Removed: This replaces the existing incurred loss model with an expected loss model and requires the use of forward-looking information to calculate credit loss estimates.
−Removed: The Company adopted ASU 2016-13 on January 1, 2023.
−Removed: The adoption of ASU 2016-13 did not have a material impact on the Company’s financial position, results of operations or cash flows.
−Removed: In August 2020, the FASB issued ASU 2020-06, “Debt—Debt with Conversion and Other Options (Subtopic 470-20)” and “Derivatives and Hedging— Contracts in Entity’s Own Equity (Subtopic 815-40):
−Removed: Accounting for Convertible Instruments and Contracts in an Entity’s Own Equity”, to clarify the accounting for certain financial instruments with characteristics of liabilities and equity.
+Added: Subsequent Events
+Added: The Company has evaluated subsequent events through the date which the financial statements were issued.
+Added: 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.
+Added: Recently Issued Accounting Standards
+Added: 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.
+Added: 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.
+Added: 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.
+Added: The Company is currently evaluating any new disclosures that may be required upon adoption of ASU 2023-07.
EYENOVIA, INC.
NOTES TO CONDENSED FINANCIAL STATEMENTS
−Removed: amendments in this update reduce the number of accounting models for convertible debt instruments and convertible preferred stock by removing the cash conversion model and the beneficial conversion feature model.
−Removed: Limiting the accounting models will result in fewer embedded conversion features being separately recognized from the host contract.
−Removed: Convertible instruments that continue to be subject to separation models are (1) those with embedded conversion features that are not clearly and closely related to the host contract, that meet the definition of a derivative, and that do not qualify for a scope exception from derivative accounting and (2) convertible debt instruments issued with substantial premiums for which the premiums are recorded as paid-in-capital.
−Removed: In addition, ASU 2020-06 improves disclosure requirements for convertible instruments and earnings-per-share guidance.
−Removed: ASU 2020-06 also revises the derivative scope exception guidance to reduce form-over-substance-based accounting conclusions driven by remote contingent events.
−Removed: The amendments in this update are effective for the Company in fiscal years beginning after December 15, 2023, and interim periods within those fiscal years.
−Removed: Early adoption is permitted.
−Removed: The Company early adopted ASU 2020-06 effective January 1, 2023 which eliminates the need to assess whether a beneficial conversion feature needs to be recognized upon the issuance of new convertible instruments.
−Removed: The adoption of ASU 2020-06 did not have a material impact on the Company’s financial position, results of operations or cash flows.
+Added: In December 2023, the FASB issued ASU 2023-09, Income Taxes (Topic 740):
+Added: Improvements to Income Tax Disclosures.
+Added: 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.
+Added: This update also includes certain other amendments to improve the effectiveness of income tax disclosures.
+Added: The amendments in ASU 2023-09 are effective for fiscal years beginning after December 15, 2024, with early adoption permitted.
+Added: 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
−Removed: As of September 30, 2023 and December 31, 2022, prepaid expenses and other current assets consisted of the following:
−Removed: September 30,
−Removed: Payroll tax receivable
+Added: As of March 31, 2024 and December 31, 2023, prepaid expenses and other current assets consisted of the following:
Prepaid insurance expenses
−Removed: Prepaid conference expenses
−Removed: Prepaid professional fees
+Added: Payroll tax receivable
Prepaid research and development expenses
+Added: Prepaid conference expenses
Prepaid general and administrative expenses
Prepaid patent expenses
−Removed: Prepaid security deposit
+Added: Prepaid rent and security deposit
+Added: Prepaid professional fees
Total prepaid expenses and other current assets
+Added: Note 4 - Intangible Assets
+Added: On August 15, 2023 (the “Effective Date”), the Company entered into a license agreement (the “License”) with Formosa Pharmaceuticals Inc.
+Added: (“Formosa”), whereby the Company acquired the exclusive U.S.
+Added: 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.
+Added: The License will remain in effect for ten years from the date of the first commercial sale of a Licensed Product, unless earlier terminated.
+Added: 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 valued at $ 1.0 million, which is included in Intangible Assets on the accompanying balance sheet.
+Added: In addition to the Upfront Payment, the Company also capitalized $ 122,945 of transaction costs, which were primarily legal expenses.
+Added: In addition, 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.
+Added: 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.
+Added: This occurred on March 11, 2024.
+Added: 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 payment.
+Added: Therefore, the Company recorded the $ 2.0 million increase in the intangible asset and the related accrual during March 2024.
+Added: Subsequent to March 31, 2024, the Company made the requisite payment (see Note 11 – Subsequent Events).
+Added: The second $ 2.0 million development milestone was earned upon FDA approval of the Licensed Product and payment is triggered on the earlier of twelve months after FDA approval or six months following the first commercial sale of the Licensed Product.
+Added: Therefore, the Company recorded an additional $ 2.0 million increase in the intangible asset and the related accrual during March 2024.
EYENOVIA, INC.
NOTES TO CONDENSED FINANCIAL STATEMENTS
−Removed: Note 4 - Property and Equipment, Net
−Removed: As of September 30, 2023 and December 31, 2022, property and equipment consisted of the following:
−Removed: September 30,
−Removed: Equipment not yet placed in service
−Removed: Leasehold improvements
−Removed: accumulated depreciation and amortization
−Removed: ( 1,141,522 )
−Removed: Property and equipment, net
−Removed: Depreciation expense was $ 318,417 and $ 82,997 for the three months ended September 30, 2023 and 2022, respectively, of which $ 316,673 and $ 80,212 , respectively, was included within research and development expenses and $ 1,744 and $ 2,785 , respectively, was included in general and administrative expenses in the accompanying statements of operations.
−Removed: Depreciation expense was $ 505,684 and $ 228,898 for the nine months ended September 30, 2023 and 2022, respectively, of which $ 499,535 and $ 221,031 , respectively, was included within research and development expenses and $ 6,149 and $ 7,867 , respectively, was included in general and administrative expenses in the accompanying statements of operations.
−Removed: As of September 30, 2023 and December 31, 2022, the Company had $ 686,753 and $ 726,326 , respectively, of outstanding deposits for equipment purchases.
Note 5 – Accrued Compensation
−Removed: As of September 30, 2023 and December 31, 2022, accrued compensation consisted of the following:
−Removed: September 30,
+Added: As of March 31, 2024 and December 31, 2023, accrued compensation consisted of the following:
Accrued bonus expenses
2 unchanged sentences
Note 6 – Accrued Expenses and Other Current Liabilities
−Removed: As of September 30, 2023 and December 31, 2022, accrued expenses and other current liabilities consisted of the following:
−Removed: September 30,
−Removed: Accrued rework of clinical supply returns
+Added: As of March 31, 2024 and December 31, 2023, accrued expenses and other current liabilities consisted of the following:
+Added: Accrued intangible asset milestone obligations
+Added: Accrued defective clinical supply settlement
Accrued research and development expenses
+Added: Accrued professional services
Credit card payable
−Removed: Accrued consulting and professional services
Accrued franchise tax
−Removed: Accrued leasehold improvements
−Removed: Accrued travel and entertainment expenses
Total accrued expenses and other current liabilities
−Removed: EYENOVIA, INC.
−Removed: NOTES TO CONDENSED FINANCIAL STATEMENTS
−Removed: Note 7 – Notes Payable
−Removed: As of September 30, 2023 and December 31, 2022, notes payable consisted of the following:
−Removed: September 30, 2023
+Added: Note 7 – Notes Payable and Convertible Notes Payable
+Added: As of March 31, 2024 and December 31, 2023, notes payable and convertible notes payable consisted of the following:
+Added: March 31, 2024
December 31, 2023
4 unchanged sentences
Current portion:
+Added: D&O insurance policy loan
Avenue - Note payable
−Removed: Avenue - Convertible note payable
Total current portion
3 unchanged sentences
Total non-current portion
−Removed: ( 1,207,839 )
−Removed: ( 1,626,458 )
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”).
−Removed: The note accrued interest at a rate of 7.11 % per year and matured on August 24, 2023.
−Removed: The D&O Loan was payable in six monthly payments of $ 103,639 consisting of principal and interest.
−Removed: During the nine months ended September 30, 2023, the Company fully repaid the $ 609,140 of principal owed on the D&O Loan.
−Removed: On May 22, 2023, pursuant to the Company’s Loan and Security Agreement (the “Loan and Security Agreement”) with Avenue Capital Management II, L.P., and related entities (“Avenue”), the Company received an additional tranche of non-convertible debt funding in the gross amount of $ 5,250,000 (which includes a $ 250,000 final payment, or 5 % of the debt funding).
−Removed: The Company paid approximately $ 126,000 of origination and legal fees connected to this debt funding.
−Removed: The additional funding was made under the provisions of the Loan and Security Agreement, bearing interest at an annual rate equal to the greater of (A) 7.0 % and (B) the prime rate as reported in The Wall Street Journal plus 4.45 %.
−Removed: The entire outstanding balance due under the Loan and Security Agreement has a maturity date of November 1, 2025.
−Removed: The additional funding triggered the extension of the interest-only period from the original 12 months to 18 months (through May 2024) for the entire outstanding balance due under the Loan and Security Agreement (initial and additional tranches).
−Removed: Following the interest-only period, the Company will make equal monthly payments of principal until the maturity date, plus interest.
−Removed: During the three months ended September 30, 2023, the Company recorded interest expense of $ 679,222 , of which $ 677,394 (which includes amortization of debt discount of $ 184,208 ) was related to the Loan and Security Agreement with Avenue and $ 1,828 was related to the D&O Loan.
−Removed: During the nine months ended September 30, 2023, the Company recorded interest expense of $ 1,691,228 , of which $ 1,678,534 was related to the Loan and Security Agreement (including amortization of debt discount of $ 497,654 ) and $ 12,694 was related to the D&O Loan.
+Added: The note accrues interest at a rate of 8.15 % per year and matures on October 24, 2024.
+Added: The D&O Loan is payable in eight monthly payments of $ 65,076 consisting of principal and interest.
+Added: During the three months ended March 31, 2024, the Company repaid $ 61,646 of principal owed on the D&O Loan.
+Added: EYENOVIA, INC.
+Added: NOTES TO CONDENSED FINANCIAL STATEMENTS
+Added: During the three months ended March 31, 2024, the Company recorded interest expense of $ 678,658 , of which $ 675,228 (including amortization of debt discount of $ 184,207 ) was related to the Loan and Security Agreement with Avenue Capital Management II, L.P.
+Added: and related entities (together, “Avenue”) and $ 3,430 was related to the D&O Loan.
+Added: During the three months ended March 31, 2023, the Company recorded interest expense of $ 454,003 , of which $ 450,394 is related to the Loan and Security Agreement with Avenue (including amortization of debt discount of $ 149,490 ) and $ 3,609 is related to the D&O Loan.
Note 8 – Commitments and Contingencies
−Removed: Clinical Supply Returns
−Removed: A certain portion of clinical supply product sold to a licensee has been determined to be defective and will be returned to the Company to be replaced or reworked.
−Removed: The defect occurred with the clinical trial Gen 1.0 device.
−Removed: The Company is still working to determine the exact quantity of the defective clinical supply and the cost to replace or rework the product.
−Removed: The current estimate of the range of the loss is between $ 400,000 and $ 600,000 , with no amount within that range being a more accurate estimate than the others at this time.
−Removed: Accordingly, the Company has recorded a charge equal to the low end of the range or $ 400,000 , which is included within other income (expense), because the original sales to the licensee were recorded on that line item.
+Added: Defective Clinical Supply
+Added: During the third quarter of 2023, a certain portion of clinical supply product sold to Bausch + Lomb had been determined to be defective.
+Added: On April 23, 2024, the Company and Bausch + Lomb executed a letter agreement (the “Side Letter”) (see Note 11 – Subsequent Events), in which the parties agreed to an estimated value of $ 0.5 million related to defective clinical supply.
+Added: 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.
+Added: During the three months ended March 31, 2024, the Company recorded an additional $ 0.1 million charge to other income (expense).
+Added: Bausch License Agreements
+Added: 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”).
+Added: 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.
+Added: 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.
+Added: 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.
+Added: 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.
+Added: 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.
+Added: Pursuant to the Letter Agreement, the Company paid Bausch + Lomb an upfront payment of $ 2.0 million in cash on January 22, 2024.
+Added: The Company has recorded this amount as an operating expense.
+Added: 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, within ten business days of the Regulatory Transfer Date, which occurred on April 11, 2024.
+Added: See Note 11 – Subsequent Events for additional information.
EYENOVIA, INC.
1 unchanged sentence
Operating Leases
−Removed: In June 2023, the Company entered into an extension agreement to renew its lease for approximately 3,800 square feet of office space in New York, NY.
−Removed: The lease was due to expire on October 31, 2023.
−Removed: The lease was extended from November 1, 2023 to December 31, 2026.
−Removed: In February 2023, the Company exercised its options to renew its three leases in Redwood City, California, for a total of approximately 6,700 square feet.
−Removed: The leases were due to expire on August 31, 2023 .
−Removed: The leases were extended from September 1, 2023 to August 31, 2025.
−Removed: A summary of the Company’s right-of-use assets and liabilities as follows:
−Removed: For the Nine Months Ended
−Removed: September 30, 2023
+Added: A summary of the Company’s right-of-use assets and liabilities is as follows:
+Added: For the Three Months Ended March 31,
Cash paid for amounts included in the measurement of lease liabilities:
Operating cash flows used in operating activities
−Removed: Right-of-use assets and lease liabilities recognized upon lease renewal
+Added: Right-of-use assets obtained in exchange for lease obligations
Operating leases
3 unchanged sentences
Operating leases
−Removed: Future minimum payments under all of the Company’s operating lease agreements are as follows:
−Removed: For the Year Ending December 31,
+Added: Future minimum payments under the Company’s operating lease agreements are as follows:
+Added: For the Years Ending December 31,
Minimum Lease Payments
Total future minimum lease payments
−Removed: amount representing imputed interest
+Added: Imputed interest
Present value of lease liabilities
5 unchanged sentences
Note 9 – Stockholders’ Equity
−Removed: Equity Incentive Plan
−Removed: On June 27, 2023, the Company’s stockholders approved an amendment to the Company’s Amended and Restated 2018 Omnibus Stock Incentive Plan, as amended, reserving an additional 1,000,000 shares of common stock for further issuance under such plan.
−Removed: EYENOVIA, INC.
−Removed: NOTES TO CONDENSED FINANCIAL STATEMENTS
At-The-Market Offering
−Removed: During the nine months ended September 30, 2023, the Company received approximately $ 4.0 million in net proceeds from the sale of 1,464,346 shares of its common stock pursuant to its Sales Agreement with Leerink Partners, formerly known as SVB Securities LLC (“Leerink Partners”) in an ”at-the-market” offering (the “At-the-Market Offering Program”).
−Removed: Registered Direct Offering
−Removed: On August 24, 2023, the Company entered into a securities purchase agreement with a certain institutional and accredited investor (the “Purchaser”), pursuant to which the Company agreed to sell, in a registered direct offering by the Company directly to the Purchaser (the “August 2023 Offering”), 4,198,633 shares of common stock, pre-funded warrants to purchase up to 2,252,979 shares of common stock (the “Pre-Funded Warrants”) and warrants to purchase up to 4,838,709 shares of common stock (the “Common Warrants” and, together with the Pre-Funded Warrants, the “Warrants”).
−Removed: The combined offering price for each share of common stock and accompanying Common Warrant was $ 1.86 , and the combined offering price for each Pre-Funded Warrant and accompanying Common Warrant was $ 1.85 .
−Removed: The Common Warrants will be exercisable beginning six months following the date of issuance and may be exercised for a period of five years from the initial exercisability date at an exercise price of $ 2.23 per share.
−Removed: The Pre-Funded Warrants were immediately exercisable and may be exercised at any time until all of the Pre-Funded Warrants are exercised in full at an exercise price of $ 0.01 per share.
−Removed: The exercise prices and numbers of shares of common stock issuable upon exercise of the Common Warrants and the Pre-Funded Warrants are subject to typical anti-dilution provisions.
−Removed: A holder may not exercise any portion of such holder’s Common Warrants or Pre-Funded Warrants to the extent that the holder would own more than 4.99 % of the Company’s outstanding common stock immediately after exercise (unless the holder otherwise elects a limitation of 9.99 %).
−Removed: The Company determined that the Warrants met the criteria to be classified as equity.
−Removed: The net cash proceeds of the August 2023 Offering were approximately $ 10.9 million after deducting cash issuance costs in the aggregate amount of approximately $ 1.1 million.
−Removed: See Warrant Modification below for details about an additional $ 1.7 million of non-cash issuance costs.
−Removed: The August 2023 Offering closed on August 29, 2023.
−Removed: Warrant Modification
−Removed: Original Warrant Issuance - March 2022
−Removed: On March 3, 2022, the Company entered into a securities purchase agreement (the “March 2022 Purchase Agreement”) with a holder (the “Holder”) relating to the issuance and sale of 3,000,000 shares of common stock, pre-funded warrants to purchase an aggregate of 1,870,130 shares of common stock and warrants to purchase an aggregate of 4,870,130 shares of common stock (the “March 2022 Investor Warrants”).
−Removed: The March 2022 Investor Warrants became exercisable beginning six months from the date of issuance and initially were exercisable for a period of five years at an exercise price of $ 3.54 per share.
−Removed: Warrant Amendment
−Removed: In connection with the August 2023 Offering (see “Registered Direct Offering” above), the Company entered into a warrant amendment agreement (the “Amendment”) with the Holder, whereby the Company agreed to amend the March 2022 Investor Warrants to (i) reduce the exercise price from $ 3.54 per share of common stock to $ 2.23 per share of common stock, (ii) extend the term of the March 2022 Investor Warrants until March 1, 2029, (iii) include a stockholder approval requirement in connection with a modification of the beneficial ownership limitation and (iv) prohibit exercise of the March 2022 Investor Warrants for the six-month period following the effective date of the Amendment.
−Removed: The Company accounted for the modification of the March 2022 Investor Warrants as an exchange of the old warrants for new warrants.
−Removed: The incremental value of the new warrant (resulting from the decrease in exercise price from $ 3.54 to $ 2.23 per share and the extension of the warrant expiration date to March 1, 2029) was measured as the excess of the fair value of the modified warrants over the fair
−Removed: EYENOVIA, INC.
−Removed: NOTES TO CONDENSED FINANCIAL STATEMENTS
−Removed: value of the original warrants immediately before modification.
−Removed: The increase in the incremental value of $ 1,738,700 was credited to additional paid-in-capital (“APIC”) and debited to APIC as an issuance cost of the August 2023 Offering.
−Removed: A summary of the warrant activity for the nine months ended September 30, 2023 is presented below:
−Removed: Outstanding January 1, 2023
−Removed: Repriced - Old (1)
−Removed: ( 4,870,130 )
−Removed: Repriced - New (1)
−Removed: Outstanding September 30, 2023
−Removed: Exercisable September 30, 2023
−Removed: Warrants represent the reset of the exercise price of the March 2022 Investor Warrants to purchase 4,870,130 shares of common stock to a price of $ 2.23 per share.
−Removed: The following table presents information related to warrants as of September 30, 2023:
−Removed: Warrants Outstanding
−Removed: Warants Exercisable
−Removed: Remaining Life
−Removed: (1) These are Pre-Funded Warrants that do not expire.
−Removed: (2) These warrants are not yet exercisable.
+Added: During the three months ended March 31, 2024, the Company received approximately $ 3.2 million in net proceeds from the sale of 1,833,323 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.
Stock-Based Compensation Expense
The Company records stock-based compensation expense related to stock options and restricted stock units (“RSUs”).
−Removed: For the three months ended September 30, 2023 and 2022, the Company recorded expense of $ 612,969 ($ 235,731 of which was included within research and development expenses and $ 377,238 was included within general and administrative expenses on the statements of operations) and $ 928,733 ($ 420,619 of which was included within research and development expenses and $ 508,114 was included within general and administrative expenses on the statements of operations), respectively.
−Removed: For the nine months ended September 30, 2023 and 2022, the Company recorded expense of $ 1,925,665 ($ 647,058 of which was included within research and development expenses and $ 1,278,607 was included within general and administrative expenses on the statements of operations) and $ 2,874,646 ($ 1,438,469 of which was included within research and development expenses and $ 1,436,177 was included within general and administrative expenses on the statements of operations), respectively.
+Added: For the three months ended March 31, 2024 and 2023, the Company recorded stock-based compensation expense of $ 546,232 ($ 206,586 which was included within research and development expenses and $ 339,646 was included within general and administrative expenses on the statements of operations) and $ 819,064 ($ 375,130 of which was included within research and development expenses and $ 443,934 was included within general and administrative expenses on the statements of operations), respectively.
EYENOVIA, INC.
1 unchanged sentence
Restricted Stock Units
−Removed: A summary of RSU activity during the nine months ended September 30, 2023 is presented below:
−Removed: Grant Date Value
+Added: A summary of the restricted stock units (“RSUs”) activity during the three months ended March 31, 2024 is presented below:
RSUs non-vested January 1, 2024
−Removed: RSUs non-vested September 30, 2023
−Removed: Vested RSUs undelivered September 30, 2023
+Added: RSUs non-vested March 31, 2024
+Added: Vested RSUs undelivered March 31, 2024
To date, RSUs have only been granted to directors in accordance with the Company’s Amended and Restated 2018 Omnibus Stock Incentive Plan.
−Removed: The Company’s policy is to defer settlement of such RSUs until the termination of such director’s service on the Company’s board of directors.
−Removed: On February 28, 2023, the Company delivered 3,289 shares of common stock in respect of RSUs upon the resignation of a director.
−Removed: On June 16, 2023, the Company delivered 44,444 shares of common stock in respect of RSUs based on the prior resignation of two directors.
−Removed: As of September 30, 2023, there was $ 203,055 of unrecognized stock-based compensation expense related to RSUs which will be recognized over a weighted average period of 1.0 years.
+Added: The Company’s policy is not to deliver shares underlying the RSUs until the termination of service.
+Added: As of March 31, 2024, there was $ 63,095 of unrecognized stock-based compensation expense related to RSUs which will be recognized over a weighted average period of 0.3 years.
Stock Options
−Removed: In applying the Black-Scholes option pricing model to stock options granted, the Company used the following approximate assumptions:
−Removed: For the Three Months Ended
−Removed: For the Nine Months Ended
−Removed: September 30,
−Removed: September 30,
−Removed: Expected term (years)
−Removed: Risk free interest rate
−Removed: 2.66 % - 3.02 %
−Removed: 3.44 % - 4.18 %
−Removed: 0.76 % - 3.35 %
−Removed: Expected volatility
−Removed: Expected dividends
−Removed: The Company has computed the fair value of stock options granted using the Black-Scholes option pricing model.
−Removed: Option forfeitures are accounted for at the time of occurrence.
−Removed: The expected term is the estimated period of time that options granted are expected to be outstanding.
−Removed: The Company utilizes the “simplified” method to develop an estimate of the expected term of “plain vanilla” employee option grants.
−Removed: The Company uses a blended volatility calculation, the components of which are the Company’s historical volatility for the period from its initial public offering through the valuation date and the average peer-group data of six comparable entities to supplement the Company’s own historical data for the preceding years in computing the expected volatility.
−Removed: Accordingly, the Company is utilizing an expected volatility figure based on a review of the historical volatility of comparable entities over a period of time equivalent to the expected life of the instrument being valued.
−Removed: The risk-free interest rate was determined from the implied yields from U.S.
−Removed: Treasury zero-coupon bonds with a remaining term consistent with the expected term of the instrument being valued.
−Removed: The Company has not declared dividends, is currently in the development stage and has no plan to declare future dividends at this time.
−Removed: There were no options granted in the three months ended September 30, 2023.
−Removed: The weighted average estimated grant date fair value of the stock options granted for the three months ended September 30, 2022 was approximately $ 1.22 per share.
−Removed: The weighted average estimated grant date fair value of the stock options granted for the nine months ended September 30, 2023 and 2022 was approximately $ 1.70 and $ 1.61 per share respectively.
+Added: A summary of the option activity during the three months ended March 31, 2024 is presented below:
+Added: Outstanding, January 1, 2024
+Added: Outstanding, March 31, 2024
+Added: Exercisable, March 31, 2024
EYENOVIA, INC.
NOTES TO CONDENSED FINANCIAL STATEMENTS
−Removed: A summary of the option activity during the nine months ended September 30, 2023 is presented below:
−Removed: Outstanding, January 1, 2023
−Removed: Forfeited/ Expired
−Removed: Outstanding September 30, 2023
−Removed: Exercisable September 30, 2023
−Removed: The following table presents information related to stock options as of September 30, 2023:
+Added: The following table presents information related to stock options as of March 31, 2024:
Options Outstanding
7 unchanged sentences
$ 6.00 - $ 6.99
−Removed: As of September 30, 2023, there was $ 2,841,102 of unrecognized stock-based compensation expense related to stock options, which will be recognized over a weighted average period of 1.8 years.
+Added: In applying the Black-Scholes option pricing model to stock options granted, the Company used the following approximate assumptions:
+Added: For the Three Months Ended
+Added: Expected term (years)
+Added: Risk free interest rate
+Added: 4.04 % - 4.24 %
+Added: 3.60 % - 4.18 %
+Added: Expected volatility
+Added: Expected dividends
+Added: As of March 31, 2024, there was $ 2,407,571 of unrecognized stock-based compensation expense related to stock options which will be recognized over a weighted average period of 2.1 years.
+Added: The weighted average estimated grant date fair value of the stock options granted for the three months ended March 31, 2024 and 2023 was approximately $ 1.33 and $ 1.61 per share, respectively.
Note 10 – Employee Benefit Plans
2 unchanged sentences
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.
−Removed: For 2023 and 2022, the Company’s Board of Directors approved a matching contribution equal to 100 % of elective deferrals up to 4 % of eligible earnings with the matching contribution subject to certain vesting requirements as outlined in the Plan documents.
−Removed: During the three months ended September 30, 2023 and 2022, the Company recorded expense of $ 46,636 and $ 39,914 associated with its matching contributions, respectively.
−Removed: During the nine months ended September 30, 2023 and 2022, the Company recorded expense of $ 171,800 and $ 173,896 associated with its matching contributions, respectively.
+Added: 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.
+Added: During the three months ended March 31, 2024 and 2023, the Company recorded expense of $ 102,483 and $ 78,969 , respectively, associated with its matching contributions.
+Added: Note 11 - Subsequent Events
+Added: Registered Direct Offering
+Added: 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.
+Added: The price per share in the Offering was $ 0.6204 .
+Added: The aggregate gross proceeds to the Company from the Offering were approximately $ 2.0 million.
EYENOVIA, INC.
NOTES TO CONDENSED FINANCIAL STATEMENTS
−Removed: Note 11 - Subsequent Events
−Removed: Exercise of Pre-Funded Warrants
−Removed: On November 2, 2023, the Purchaser exercised a portion of its Pre-Funded Warrants in order to purchase 1,223,979 of the Company’s common stock at the exercise price of $ 0.01 per share.
−Removed: The total proceeds of the transaction were $ 12,240 (see “Registered Direct Offering” in Note 9 – Stockholders’ Equity).
+Added: At-The-Market Offering
+Added: Subsequent to March 31, 2024, the Company received approximately $ 317,000 in net proceeds from the sale of 347,794 shares of its common stock pursuant to its Sales Agreement with Leerink Partners in its ”at-the-market” offering.
+Added: On April 8, 2024, the Company suspended its use of and terminated the prospectus supplement related to the potential issuance from time to time of the Company’s common stock pursuant to the Sales Agreement, unless and until a new prospectus supplement or a new registration statement is filed.
+Added: Reversion of Licensed Rights Under Mutual Termination Agreement with Bausch + Lomb
+Added: On January 12, 2024, the Company and Bausch + Lomb entered into the Letter Agreement, pursuant to which Eyenovia reacquired the rights to the CHAPERONE trial at the Regulatory Transfer Completion Date (as defined in the Letter Agreement;
+Added: hereinafter the “Transfer Date”).
+Added: See Note 8 – Commitments and Contingencies – Bausch License Agreements for details of the Letter Agreement.
+Added: 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.
+Added: On May 3, 2024, the Company issued Bausch + Lomb 2,299,397 shares of the Company’s common stock, valued at $ 3.0 million, in satisfaction of its obligations pursuant to the Letter Agreement.
+Added: On April 23, 2024, the Company and Bausch + Lomb entered into 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.
+Added: 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.
+Added: In addition, the Company purchased $ 0.5 million of clinical supplies from Bausch + Lomb in April 2024.
+Added: Intangible Asset Payment
+Added: Based on the achievement of the first development milestone (see Note 4 – Intangible Assets) which occurred on March 11, 2024, 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 valued at $ 1.0 million on April 29, 2024, which is included in Intangible Assets on the accompanying balance sheet.
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.