2 unchanged sentences
Condensed Balance Sheets
−Removed: September 30,
Current Assets:
Cash and cash equivalents
−Removed: Restricted cash
−Removed: Deferred license costs
−Removed: License fee and expense reimbursements receivables
+Added: License fee and expense reimbursements receivable
Prepaid expenses and other current assets
Total Current Assets
+Added: Restricted cash
Property and equipment, net
−Removed: Security deposit
+Added: Security deposits
+Added: Equipment deposits
Liabilities and Stockholders’ Equity
4 unchanged sentences
Deferred rent - current portion
−Removed: Deferred license fee
−Removed: Notes payable - current portion
+Added: Notes payable - current portion, net
Total Current Liabilities
Deferred rent - non-current portion
−Removed: Notes payable - non-current portion
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, 2021 and December 31, 2020, respectively
+Added: 0 shares issued and outstanding as of March 31, 2022 and December 31, 2021
Common stock, $ 0.0001 par value, 90,000,000 shares authorized;
−Removed: 25,963,185 and 24,978,585 shares issued and outstanding as of September 30, 2021 and December 31, 2020, respectively
+Added: 31,698,424 and 28,426,616 shares issued and outstanding as of March 31, 2022 and December 31, 2021, 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
Cost of revenue
−Removed: ( 1,600,000 )
Operating Expenses:
5 unchanged sentences
( 5,366,638 )
−Removed: ( 16,016,955 )
−Removed: ( 15,582,607 )
Other Income (Expense):
−Removed: Small Business Administration Economic Injury Disaster Grant
−Removed: Extinguishment of PPP 7(a) loan
−Removed: Other expense
+Added: Other (expense) income,net
Interest expense
2 unchanged sentences
( 5,351,667 )
−Removed: ( 15,761,665 )
−Removed: ( 15,563,005 )
−Removed: Net Loss Per Share
−Removed: - Basic and Diluted
−Removed: Weighted Average Number of Common Shares Outstanding
−Removed: - Basic and Diluted
+Added: Net Loss Per Share - Basic and Diluted
+Added: Weighted Average Number of Common Shares Outstanding - Basic and Diluted
The accompanying notes are an integral part of these condensed financial statements.
1 unchanged sentence
Condensed Statements of Changes in Stockholders’ Equity
−Removed: For the Three and Nine Months Ended September 30, 2021
+Added: For the Three Months Ended March 31, 2022
Stockholders’
1 unchanged sentence
( 90,219,306 )
−Removed: Exercise of stock warrants
+Added: Issuance of common stock and warrants in registered direct offering [1]
+Added: Issuance of common stock in At the Market offering [2]
Stock-based compensation
+Added: Issuance of common stock related to vested restricted stock units
( 7,339,665 )
2 unchanged sentences
( 97,558,971 )
−Removed: Exercise of stock warrants
−Removed: Exercise of stock options
−Removed: Issuance of SVB warrants [1]
−Removed: Stock-based compensation
−Removed: ( 4,841,400 )
−Removed: ( 4,841,400 )
−Removed: Balance - June 30, 2021
−Removed: ( 87,633,986 )
−Removed: Exercise of stock options
−Removed: Stock-based compensation
−Removed: ( 5,568,598 )
−Removed: ( 5,568,598 )
−Removed: Balance - September 30, 2021
−Removed: ( 93,202,584 )
−Removed: [1] Allocated fair value of warrants of $ 354,539 , less allocated issuance costs of $ 3,149 .
−Removed: EYENOVIA, INC.
−Removed: Condensed Statements of Changes in Stockholders’ Equity (Continued)
−Removed: For the Three and Nine Months Ended September 30, 2020
+Added: [1] Includes gross proceeds of $ 14,981,299 less total issuance costs of $ 83,391 .
+Added: [2] Includes gross proceeds of $ 886,974 , less total issuance costs of $ 26,609 .
+Added: For the Three Months Ended March 31, 2021
Stockholders’
1 unchanged sentence
( 77,440,919 )
−Removed: Issuance of common stock and warrants in private placement [1]
−Removed: Stock-based compensation
−Removed: ( 5,450,910 )
−Removed: ( 5,450,910 )
−Removed: Balance - March 31, 2020
−Removed: ( 63,121,962 )
Exercise of stock warrants
2 unchanged sentences
( 5,351,667 )
−Removed: Balance -June 30, 2020
−Removed: ( 68,137,527 )
−Removed: Issuance of common stock in public offering [2]
−Removed: Exercise of stock warrants
−Removed: Exercise of stock options
−Removed: Stock-based compensation
−Removed: ( 5,096,530 )
−Removed: ( 5,096,530 )
−Removed: Balance – September 30, 2020
+Added: Balance - March 31, 2021
( 82,792,586 )
−Removed: [1] Includes gross proceeds of $ 5,984,931 , less total issuance costs of $ 533,189 .
−Removed: [2] Includes gross proceeds of $ 13,800,002 , less total issuance costs of $ 1,304,294 .
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
2 unchanged sentences
Adjustments to reconcile net loss to net cash used in operating activities:
+Added: Stock-based compensation
Depreciation of property and equipment
Amortization of debt discount
−Removed: Extinguishment of PPP 7(a) Loan
−Removed: Stock-based compensation
Changes in operating assets and liabilities:
2 unchanged sentences
Deferred license costs
−Removed: ( 1,600,000 )
Accounts payable
3 unchanged sentences
( 2,000,000 )
−Removed: Security deposit
Deferred rent
4 unchanged sentences
Purchases of property and equipment
−Removed: ( 1,165,066 )
+Added: Vendor deposits for property and equipment
Net Cash Used In Investing Activities
−Removed: ( 1,165,066 )
Cash Flows From Financing Activities
−Removed: Proceeds from sale of common stock and warrants in private placement [1]
−Removed: Proceeds from sale of common stock in public offering [2]
+Added: Proceeds from sale of common stock and warrants in registered direct offering [1]
+Added: Issuance of common stock in At the Market Offering [2]
Proceeds from exercise of stock warrants
−Removed: Proceeds from PPP 7(a) Loan
−Removed: Proceeds from SVB loan
Repayments of notes payable
Payment of offering issuance costs
−Removed: Payment of loan issuance costs
−Removed: Proceeds from exercise of stock options
Net Cash Provided By Financing Activities
−Removed: Net (Decrease) Increase in Cash and Cash Equivalents
+Added: Net Increase (Decrease) in Cash and Cash Equivalents
( 3,464,780 )
1 unchanged sentence
Cash and cash equivalents - End of Period
−Removed: [1] Includes gross proceeds of $ 5,984,931 , less issuance costs of $ 415,795 deducted directly from the private placement.
−Removed: [2] Includes gross proceeds of $ 13,800,002 , less issuance costs of $ 1,066,000 deducted directly from the offering proceeds.
−Removed: EYENOVIA, INC.
−Removed: Condensed Statements of Cash Flows (Continued)
−Removed: Cash and restricted cash consisted of the following:
+Added: [1] Includes gross proceeds of $ 14,981,299 , of which $ 5,741,299 is pre-funded warrants.
+Added: [2] Includes gross proceeds of $ 886,974 , less total issuance costs of $ 26,609 .
+Added: Cash,cash equivalents and restricted cash consisted of the following:
+Added: Cash and cash equivalents
Restricted cash
2 unchanged sentences
Supplemental Disclosure of Non-Cash Investing and Financing Activities
−Removed: Accrual of public offering costs
Purchase of insurance premium financed by note payable
−Removed: Issuance of SVB stock warrants
+Added: Issuance of common stock related to vested restricted stock units
The accompanying notes are an integral part of these condensed financial statements.
3 unchanged sentences
Eyenovia, Inc.
−Removed: (“Eyenovia” or the “Company”) is a clinical stage ophthalmic biopharmaceutical company developing a pipeline of microdose array print (MAP™) therapeutics.
−Removed: Eyenovia aims to achieve clinical microdosing of next-generation formulations of well-established ophthalmic pharmaceutical agents using its high-precision targeted ocular delivery system branded the Optejet ® , which has the potential to replace conventional eye dropper delivery and improve safety, tolerability, patient compliance and topical delivery success for ophthalmic eye treatments.
−Removed: In the clinic, the Optejet has demonstrated the ability to horizontally deliver ophthalmic medication with a success rate significantly higher than that of traditional eye drops (~ 90 % vs.
−Removed: Using its proprietary delivery technology, Eyenovia is developing the next generation of smart ophthalmic therapies which target new indications or new combinations where there are currently no comparable drug therapies approved by the U.S.
−Removed: Food and Drug Administration (the “FDA”).
−Removed: Eyenovia’s microdose therapeutics follow the FDA-designated pharmaceutical registration and regulatory process.
−Removed: On October 25, 2021, the Company announced the reclassification of the Company’s proprietary, first-in-class combination microdose formulation of tropicamide and phenylephrine for in-office pupil dilation, (“MydCombi” or “MicroStat”) as a drug-device combination product by the FDA in a Complete Response Letter (“CRL”) received on October 22, 2021, following a change in the agency’s legal interpretation of its authorities imposed by a recent court ruling.
−Removed: The Company is preparing the necessary documents for expedited resubmission of the new drug application for MydCombi in response to the CRL.
−Removed: The Company believes that its other product candidates will similarly be classified by the FDA as drug-led combination products that would be subject to marketing approval via new drug applications.
+Added: (“Eyenovia” or the “Company”) is a clinical stage ophthalmic company developing a pipeline of advanced therapeutics based on the Company’s proprietary microdose array print (MAP TM ) platform technology.
+Added: The Company aims to achieve clinical microdosing of next-generation formulations of novel and existing ophthalmic pharmaceutical agents using its high-precision targeted ocular delivery system, branded the Optejet®.
+Added: Optejet µ-therapeutics have the potential to replace conventional eye dropper delivery and improve safety, tolerability, patient compliance and topical delivery success for ophthalmic eye treatments.
+Added: In the clinic, the Optejet has demonstrated that its targeted horizontal microdose delivery can achieve a significantly higher rate of successful ocular topical delivery compared to the established rate reported with traditional eye drops (~ 90 % vs.
+Added: The Company’s technology is designed to achieve single-digit µl-volume physiologic drug delivery with up to a 75% reduction in ocular drug and preservative topical dosing and has demonstrated significant improvement in the therapeutic index in drugs used for presbyopia, mydriasis and intraocular pressure (“IOP”) lowering through six Phase II and Phase III trials.
+Added: Conventional eye formulations lack high-precision micro-volume delivery and expose the ocular surface to approximately 300% more medication and preservatives than are physiologically indicated leading to clinically recognized ocular and non-ocular side effects.
+Added: Using the Optejet, the Company is developing the next generation of smart ophthalmic therapeutics which target new indications or new combinations where there are currently no or few drug therapies approved by the U.S.
+Added: Food and Drug Administration (“FDA”).
+Added: The Company’s microdose therapeutics follow the FDA-designated combination product registration and regulatory process.
+Added: The Company’s products are classified by the FDA as drug-device combination products with drug primary mode of action, meaning that the Center for Drug Evaluation and Research (“CDER”) is designated as the lead center with primary jurisdictional oversight.
+Added: Accordingly, the product candidates are submitted to the FDA CDER for premarket review and approval under new drug applications, or NDAs.
The accompanying unaudited condensed financial statements have been prepared in accordance with accounting principles generally accepted in the United States of America (“U.S.
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, 2021 and for the three and nine months ended September 30, 2021 and 2020.
−Removed: The results of operations for the three and nine months ended September 30, 2021 are not necessarily indicative of the operating results for the full year ending December 31, 2021 or any other period.
−Removed: 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, 2020 and for the year then ended, which were included in the Company’s Annual Report on Form 10-K filed with the U.S.
−Removed: Securities and Exchange Commission (“SEC”) on March 30, 2021.
+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, 2022 and for the three months ended March 31, 2022 and 2021.
+Added: The results of operations for the three months ended March 31, 2022 are not necessarily indicative of the operating results for the full year ending December 31, 2022 or any other period.
+Added: 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, 2021 and for the year then ended, which were included in the Company’s Annual Report on Form 10-K filed with the Securities and Exchange Commission (“SEC”) on March 30, 2022.
Note 2 – Summary of Significant Accounting Policies
1 unchanged sentence
Liquidity and Going Concern
−Removed: As of September 30, 2021, the Company had unrestricted cash and cash equivalents of approximately $ 13.5 million and an accumulated deficit of approximately $93.2 million.
−Removed: For the nine months ended September 30, 2021 and 2020, the Company incurred net losses of approximately $15.8 million and $15.6 million, respectively, and used cash in operations of approximately $15.0 million and $11.9 million, respectively.
−Removed: Pursuant to the At-The-Market Offering (see Note 9 – Stockholders’ Equity – At-The-Market Offering and Note 11 – Subsequent Events – At-The-Market Offering), the Company commenced sales of its common stock on October 6, 2021.
−Removed: As of the filing date, the Company has received approximately $ 12.8 million in gross proceeds and $ 12.4 million in net proceeds from the sale of 2,435,604 shares of its common stock.
+Added: As of March 31, 2022, the Company had unrestricted cash of approximately $ 26.7 million and an accumulated deficit of approximately $ 97.6 million.
+Added: For the three months ended March 31, 2022 and 2021, the Company incurred net losses of approximately $ 7.3 million and $ 5.4 million, respectively, and used cash in operations of approximately $ 8.2 million and $ 4.6 million, respectively.
The Company does not have recurring revenue and has not yet achieved profitability.
2 unchanged sentences
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.
−Removed: Implementation of the Company’s plans and its ability to continue as a going concern will depend upon the Company’s ability to generate sufficient recurring revenues or the Company’s ability to raise further capital, through the sale of additional equity or debt securities or otherwise, to support its future operations.
+Added: 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 the sale of additional equity or debt securities or otherwise, to support its future operations.
The Company’s operating needs include the planned costs to operate its business, including amounts required to fund working capital and capital expenditures.
−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
+Added: 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
EYENOVIA, INC.
NOTES TO CONDENSED FINANCIAL STATEMENTS
−Removed: 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 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.
+Added: complement its product and service offerings.
+Added: If the Company is unable to 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, Cash Equivalents and Restricted Cash
The Company considers all highly liquid investments with an original maturity of three months or less to be cash equivalents in the financial statements.
−Removed: Cash and cash equivalents that are restricted as to withdrawal or use under the terms of certain executed agreements are recorded as Restricted Cash on the balance sheets, such as the collateralized money market account pursuant to the Loan and Security Agreement, dated May 7, 2021 with Silicon Valley Bank (“SVB”), as amended on September 29, 2021 by the First Amendment to the Loan and Security Agreement.
+Added: Cash and cash equivalents that are restricted as to withdrawal or use under the terms of certain executed agreements are recorded as Restricted Cash on the balance sheets, such as the collateralized money market account pursuant to the Loan and Security Agreement, dated May 7, 2021 with Silicon Valley Bank (“SVB”), as amended on September 29, 2021 by the First Amendment to the Loan and Security Agreement (the “First Amendment”).
See Note 6 - Notes Payable - Silicon Valley Bank Loan.
−Removed: In connection with which the Company pledged to establish and maintain a collateralized money market account in the amount of $ 7,875,000 .
+Added: In connection with the First Amendment, the Company pledged to establish and maintain a collateralized money market account in the amount of $ 7,875,000 .
The Company has cash deposits in a financial institution which, at times, may be in excess of Federal Deposit Insurance Corporation (“FDIC”) insurance limits.
The Company has not experienced losses in such accounts and periodically evaluates the creditworthiness of its financial institutions.
−Removed: As of September 30, 2021 and December 31, 2020, the Company had cash balances in excess of FDIC insurance limits of $ 21,125,871 and $ 28,121,828 , respectively.
+Added: As of March 31, 2022 and December 31, 2021, the Company had cash balances in excess of FDIC insurance limits of $ 26,466,269 and $ 19,211,850 , respectively.
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 weighted average vested but unsettled restricted stock units.
+Added: Basic net loss per common share is computed by dividing net loss by the weighted average number of common shares outstanding during the period plus fully vested shares that are subject to issuance for little or no monetary consideration.
Diluted earnings per share reflects the potential dilution that could occur if securities or other instruments to issue common stock were exercised or converted into common stock.
The following securities are excluded from the calculation of weighted average diluted common shares because their inclusion would have been anti-dilutive:
−Removed: September 30,
+Added: Restricted stock units
Total potentially dilutive shares
Revenue Recognition
−Removed: Our revenues are generated primarily through research, development and commercialization agreements.
−Removed: The terms of such agreements may contain multiple promised goods and services, which may include (i) licenses to our intellectual property, and (ii) in certain cases, payment in connection with the manufacturing and delivery of clinical supply materials.
+Added: The Company’s revenues are generated primarily through research, development and commercialization agreements.
+Added: The terms of such agreements may contain multiple promised goods and services, which may include (i) licenses to its intellectual property, and (ii) in certain cases, payment in connection with the manufacturing and delivery of clinical supply materials.
Payments to us under these arrangements typically include one or more of the following:
2 unchanged sentences
payments for clinical product supply, and royalties on future product sales.
−Removed: We analyze our arrangements to assess whether such arrangements involve joint operating activities.
−Removed: For collaboration arrangements that are deemed to be within the scope of Accounting Standards Codification (“ASC”) Topic 808, “Collaborative Arrangements” (“ASC 808”), we allocate the contract consideration between such joint operating activities and elements that are reflective of a vendor-customer relationship and, therefore, within the scope of ASC Topic 606, “Revenue from Contracts with Customers” (“ASC 606”).
−Removed: Our policy is to recognize amounts allocated to joint operating activities as a reduction in research and development expense.
+Added: The Company analyzes its arrangements to assess whether such arrangements involve joint operating activities.
+Added: For collaboration arrangements that are deemed to be within the scope of Accounting Standards Codification (“ASC”) Topic 808, “Collaborative Arrangements” (“ASC 808”), the Company allocates the contract consideration between such joint operating activities and elements that are reflective of a vendor-customer relationship and, therefore, within the scope of ASC Topic 606, “Revenue from Contracts with Customers” (“ASC 606”).
+Added: The Company’s policy is to recognize amounts allocated to joint operating activities as a reduction in research and development expense.
EYENOVIA, INC.
NOTES TO CONDENSED FINANCIAL STATEMENTS
−Removed: Under ASC 606, we recognize revenue when our customers obtain control of promised goods or services, in an amount that reflects the consideration which we expect to receive in exchange for those goods or services.
−Removed: To determine revenue recognition for arrangements that we determine are within the scope of ASC 606, we perform the following five steps:
+Added: Under ASC 606, the Company recognizes revenue when its customers obtain control of promised goods or services, in an amount that reflects the consideration the Company expects to receive in exchange for those goods or services.
+Added: To determine revenue recognition for arrangements that the Company determines are within the scope of ASC 606, the Company performs the following five steps:
Identify the contract with the customer;
3 unchanged sentences
Recognize revenue when the company satisfies a performance obligation.
−Removed: We must make significant judgments in our revenue recognition process, including identifying performance obligations in the contract, estimating the amount of variable consideration to include in the transaction price and allocating the transaction price to each performance obligation.
+Added: The Company must make significant judgments in its revenue recognition process, including identifying performance obligations in the contract, estimating the amount of variable consideration to include in the transaction price and allocating the transaction price to each performance obligation.
In addition, arrangements that include rights to additional goods or services that are exercisable at a customer’s discretion are generally considered discretionary purchase options.
−Removed: We assess if these options provide a material right to the customer and if so, they are considered performance obligations.
−Removed: For upfront license fees, we must consider how many performance obligations are in the contract and, if more than one, how to allocate the fee to those performance obligations upon satisfaction of the performance obligation(s).
+Added: The Company assesses whether these options provide a material right to the customer and if so, they are considered performance obligations.
+Added: For upfront license fees, the Company must consider how many performance obligations are in the contract and, if more than one, how to allocate the fee to those performance obligations upon satisfaction of the performance obligation(s).
Milestone payments represent variable consideration that will be recognized when the performance obligation is achieved.
4 unchanged sentences
1) an upfront license fee;
−Removed: 2) milestone payments;
−Removed: and 3) royalty payments.
−Removed: See Note 7 – Commitments and Contingencies for additional details.
+Added: 2) milestone payments and
+Added: 3) royalty payments.
+Added: Clinical Supply Arrangements
+Added: Bausch Health and Arctic Vision have contracted with the Company to manufacture and supply them with the appropriate drug-device combination products to conduct their clinical trials on a cost plus 10 % mark-up basis.
+Added: Our licensing agreements with Bausch Health and Arctic Vision represent collaborative arrangements and they are 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) to report the net income from the clinical supply arrangements as other income.
+Added: Reclassifications
+Added: Certain prior period balances have been reclassified in order to conform to current period presentation.
+Added: These reclassifications have no effect on previously reported results of operations or loss per share.
Recently Adopted Accounting Standards
−Removed: In August 2018, the FASB issued Accounting Standards Update (“ASU”) No.
−Removed: 2018-13 “Fair Value Measurement (Topic 820):
−Removed: Disclosure Framework—Changes to the Disclosure Requirements for Fair Value Measurement” (“ASU 2018-13”).
−Removed: The amendments in ASU 2018-13 modify the disclosure requirements on fair value measurements based on the concepts in the FASB Concepts Statement, including the consideration of costs and benefits.
−Removed: The amendments on changes in unrealized gains and losses, the range and weighted average of significant unobservable inputs used to develop Level 3 fair value measurements, and the narrative description of measurement uncertainty should be applied prospectively for only the most recent interim or annual period presented in the initial fiscal year of adoption.
−Removed: All other amendments should be applied retrospectively to all periods presented upon their effective date.
−Removed: The amendments are effective for fiscal years beginning after December 15, 2020.
−Removed: The Company adopted ASU 2018-13 effective January 1, 2021.
−Removed: This standard did not have a material impact on the Company’s financial position, results of operations or cash flow.
−Removed: Recently Issued Accounting Standards
−Removed: In February 2016, the FASB issued ASU No.
−Removed: 2016-02 “Leases (Topic 842)” (“ASU 2016-02”).
−Removed: ASU 2016-02 requires that a lessee recognize the assets and liabilities that arise from operating leases.
−Removed: A lessee should recognize in the statement of financial position a liability to make lease payments (the lease liability) and a right-of-use asset representing its right to use the underlying asset for the lease term.
−Removed: For leases with a term of 12 months or less, a lessee is permitted to make an accounting policy election by class of underlying asset not to recognize lease assets and lease liabilities.
−Removed: In transition, lessees and lessors are required to recognize and measure leases at the beginning of the earliest period presented using a modified retrospective approach.
−Removed: ASU 2016-02, as amended, is now effective for fiscal years beginning after December 15, 2021, and interim periods within fiscal years beginning after December 15, 2022.
−Removed: The FASB issued ASU No.
−Removed: 2019-01 “Leases (Topic 842) Codification Improvements” in March 2019 and ASU No.
−Removed: 2018-10 “Codification Improvements to Topic 842, Leases” and ASU No.
−Removed: 2018-11 “Leases (Topic 842) Targeted Improvements” in July 2018, and ASU No.
−Removed: EYENOVIA, INC.
−Removed: NOTES TO CONDENSED FINANCIAL STATEMENTS
−Removed: 2018-20 “Leases (Topic 842) - Narrow Scope Improvements for Lessors” in December 2018.
−Removed: ASU 2019-01, ASU 2018-10 and ASU 2018-20 provide certain amendments that affect narrow aspects of the guidance issued in ASU 2016-02.
−Removed: ASU 2018-11 allows all entities adopting ASU 2016-02 to choose an additional (and optional) transition method of adoption, under which an entity initially applies the new leases standard at the adoption date and recognizes a cumulative-effect adjustment to the opening balance of retained earnings in the period of adoption.
−Removed: The Company is currently evaluating ASU 2016-02 and its impact on its financial position, results of operations, and cash flows.
−Removed: On May 3, 2021, the Financial Accounting Standards Board (the “FASB”) issued ASU No.
+Added: On May 3, 2021, the Financial Accounting Standards Board (the “FASB”) issued Accounting Standards Update (“ASU”) No.
2021-04, “Earnings Per Share (Topic 260), Debt—Modifications and Extinguishments (Subtopic 470-50), Compensation—Stock Compensation (Topic 718), and Derivatives and Hedging—Contracts in Entity’s Own Equity (Subtopic 815-40):
2 unchanged sentences
Issuers should apply the new standard prospectively to modifications or exchanges occurring after the effective date of the new standard.
−Removed: Early adoption is permitted, including adoption in an interim period.
−Removed: If an issuer elects to early adopt the new standard in an interim period, the guidance should be applied as of the beginning of the fiscal year that includes that interim period.
−Removed: The Company is currently evaluating ASU 2021-04 and its impact on its financial position, results of operations, and cash flows.
+Added: The Company adopted ASU 2021-04 effective January 1, 2022.
+Added: This standard did not have a material impact on its financial position, results of operations or cash flow.
+Added: EYENOVIA, INC.
+Added: NOTES TO CONDENSED FINANCIAL STATEMENTS
Note 3 – Prepaid Expenses and Other Current Assets
−Removed: As of September 30, 2021 and December 31, 2020, prepaid expenses and other current assets consisted of the following:
−Removed: September 30,
−Removed: Payroll tax receivable
+Added: As of March 31, 2022 and December 31, 2021, prepaid expenses and other current assets consisted of the following:
Prepaid insurance expenses
−Removed: Prepaid research and development expenses
−Removed: Prepaid general and administrative expenses
−Removed: Prepaid licenses and subscriptions
−Removed: Prepaid patent expenses
−Removed: Prepaid conference expenses
+Added: Payroll tax receivable
+Added: Clinical supply deferred costs
+Added: Prepaid professional fees
+Added: Prepaid general and admin expenses
Prepaid board of directors fees
+Added: Prepaid conference expenses
+Added: Prepaid patent expenses
Prepaid rent and security deposit
1 unchanged sentence
Note 4 – Accrued Compensation
−Removed: As of September 30, 2021 and December 31, 2020, accrued compensation consisted of the following:
−Removed: September 30,
+Added: As of March 31, 2022 and December 31, 2021, accrued compensation consisted of the following:
Accrued bonus expenses
1 unchanged sentence
Total accrued compensation
−Removed: EYENOVIA, INC.
−Removed: NOTES TO CONDENSED FINANCIAL STATEMENTS
Note 5 – Accrued Expenses and Other Current Liabilities
−Removed: As of September 30, 2021 and December 31, 2020, accrued expenses and other current liabilities consisted of the following:
−Removed: September 30,
−Removed: Accrued research and development expenses
+Added: As of March 31, 2022 and December 31, 2021, accrued expenses and other current liabilities consisted of the following:
Accrued consulting and professional services
+Added: Accrued interest
+Added: Accrued research and development expenses
Credit card payable
Accrued franchise tax
−Removed: Accrued licensing fees
−Removed: Accrued interest
−Removed: Accrued expense reimbursements
+Added: Accrued travel and entertainment expenses
Total accrued expenses and other current liabilities
Note 6 – Notes Payable
−Removed: As of September 30, 2021 and December 31, 2020, notes payable consisted of the following:
−Removed: September 30, 2021
+Added: As of March 31, 2022 and December 31, 2021, notes payable consisted of the following:
+Added: March 31, 2022
December 31, 2021
−Removed: BankDirect Capital Finance loan
−Removed: Paycheck Protection Program loan
−Removed: Silicon Valley Bank loan
−Removed: BankDirect Capital Finance Loan
−Removed: On February 24, 2021, the Company issued a note payable for the purchase of a directors and officers liability insurance policy.
−Removed: The note payable is payable in nine month ly payments consisting of principal and interest amounting to $ 79,343 for an aggregate principal amount of $ 705,360 .
−Removed: The note accrues interest at a rate of 2.96 % per year and matures on November 24, 2021 .
−Removed: Paycheck Protection Program Loan
−Removed: On May 8, 2020, the Company received cash proceeds of $ 463,353 pursuant to a loan provided in connection with the Paycheck Protection Program under the CARES Act (the “PPP Loan”).
−Removed: The PPP Loan provided for monthly installment payments of $ 19,508 beginning in August 2021 with the remaining balance due on May 3, 2022, the maturity date.
−Removed: The PPP Loan incurred interest at a fixed rate of 1.00 % per annum.
−Removed: Under the terms of the CARES Act, as amended by the Paycheck Protection Program Flexibility Act of 2020, the Company was eligible to apply for and receive forgiveness for all or a portion of its PPP Loan.
−Removed: The Company applied for loan forgiveness on the PPP Loan in March 2021.
−Removed: The Company received notification in August 2021 that it had received approval for full loan forgiveness of the PPP Loan in the amount of $ 463,353 .
−Removed: The Company has recorded this extinguishment as other income in the condensed statement of operations for the three and nine months ended September 30, 2021.
−Removed: The Company also received notification of forgiveness of accrued interest payable of $ 5,738 , which has been reversed from interest expense.
+Added: D&O insurance policy loan
Silicon Valley Bank loan
−Removed: On May 7, 2021 (the “Effective Date”), the Company entered into a Loan and Security Agreement (the “Loan”) with Silicon Valley Bank (“SVB”) for an aggregate principal amount of up to $ 25.0 million.
−Removed: The Loan bears interest at an annual rate equal to the greater of (a) the sum of 1.25% plus the prime rate as reported in The Wall Street Journal and (b) 5.00 %.
−Removed: The Loan is secured by all of the Company’s tangible assets.
−Removed: The Loan matures on May 1, 2025 .
−Removed: The Loan requires monthly interest-only payments until June 1, 2022.
−Removed: The interest-only period can be extended to June 1, 2023, upon the occurrence of a milestone event.
−Removed: Upon the end of the interest-only
+Added: Notes payable, current
EYENOVIA, INC.
NOTES TO CONDENSED FINANCIAL STATEMENTS
−Removed: period, the Company will make regular monthly amortizing payments of principal and interest through the maturity date.
−Removed: The Loan indicates a prepayment fee of 1.0 % to 3.0 %, as follows:
−Removed: i) prepayment fee of 3.0 % of the principal balance made on or prior to the first anniversary of the Effective Date;
−Removed: ii) prepayment fee of 2.0 % of the principal balance made on or prior to the second anniversary of the Effective Date;
−Removed: or iii) prepayment fee of 1.0 % of the principal balance made on or prior to the third anniversary of the Effective Date.
−Removed: The Loan also provides for a final payment.
−Removed: The final payment is in addition to and not a substitution for the regular monthly payments of principal plus accrued interest due on the earliest to occur of the loan maturity date, the repayment of the loan in full or the termination of the Loan Agreement, in an amount equal to the original aggregate principal amount of the multiplied by 5.0 %.The Company is accreting the final payment as accrued interest over the term of the Loan.
−Removed: The initial tranche of the Loan, in the amount of $ 7.5 million was received by the Company on May 7, 2021.
−Removed: In connection with the Loan, the Company issued warrants to SVB to purchase 91,884 shares of common stock at an exercise price per share equal to $ 4.76 .
−Removed: The warrants are exercisable for a period of ten years from the date of issuance.
−Removed: At the Company’s option, the Company has the ability to draw down the remaining $ 17.5 million in gross proceeds in two tranches over the next two years based upon the achievement of several milestones in accordance with the terms of the Loan.
−Removed: On September 29, 2021, the Company and SVB executed the First Amendment to the Loan and Security Agreement (the “Amendment”).
−Removed: In accordance with the Amendment, the Company must maintain a collateralized money market account in the amount of $ 7,875,000 .
−Removed: The Company has recorded this amount as Restricted Cash.
−Removed: See Note 2 - Summary of Significant Accounting Policies - Cash, Cash Equivalents and Restricted Cash.
−Removed: This account must be maintained until the Release Event occurs (defined as when the Company has received approval by the FDA of the MydCombi product and achieved the minimum equity raise under the terms of the amended agreement, on or prior to November 30, 2021).
−Removed: Given the FDA’s recent reclassification of MydCombi as a drug-device combination and the need to resubmit a new drug application in early 2022, (See Note 11 - Subsequent Events), the restricted cash will become callable on November 30, 2021, at SVB’s election, to satisfy the Loan obligations.
−Removed: Therefore, the Loan has been fully classified as a current note payable.
−Removed: During the three and nine months ended September 30, 2021, the Company recorded interest expense relating to the Loan of $ 95,833 and $ 150,349 , respectively.
−Removed: The Company determined that the warrants should be equity-classified and that the relative fair value was $ 354,539 , by using the Black-Scholes option pricing methodology using the following assumptions:
−Removed: stock price of $ 4.76 ;
−Removed: expected term of 10.0 years;
−Removed: volatility of 89.0 % and a risk-free interest rate of 1.60 %.
−Removed: The Company incurred $ 66,618 of debt issuance costs, of which $ 63,469 was allocated to the debt and $ 3,149 was allocated to the warrants.
−Removed: The relative fair value of the warrants and the issuance costs allocated to the debt were recorded as debt discount and are being amortized over the four-year term of the note.
−Removed: See the table below for additional details:
−Removed: September 30, 2021
−Removed: Gross loan proceeds
−Removed: Debt discount:
−Removed: Relative fair value of warrants
−Removed: Relative fair value of issuance costs
−Removed: Amortization of debt discount
+Added: On February 24, 2022, the Company issued a note payable for the purchase of a directors and officers’ liability insurance policy (the “D&O Loan”).
+Added: The D&O Loan is payable in six monthly payments consisting of principal and interest amounting to $ 113,628 for an aggregate principal amount of $ 675,331 .
+Added: The note accrues interest at a rate of 3.26 % per year and matures on August 24, 2022 .
+Added: During the three months ended March 31, 2022, the Company repaid $ 111,793 of principal balance on the D&O Loan.
+Added: During the three months ended March 31, 2022, the Company recorded interest expense of $ 145,237 , of which $ 143,403 is related to the SVB loan (including amortization of debt discount of $ 26,214 ) and $ 1,834 is related to the D&O Loan.
Note 7 – Commitments and Contingencies
−Removed: See Note 8 - Related Party Transactions for certain commitments and contingencies entered into with certain related parties.
+Added: Employment Agreements
+Added: On February 14, 2022, the Compensation Committee of the Board approved amendments to the Employment Agreements with its executive officers (the “Employment Agreement Addendums”).
+Added: Each of the Employment Agreement Addendums provides that if the executive’s employment is terminated by the Company without “Cause” or the executive suffers an “Involuntary Termination” (each as defined in the employment agreements), provided that the executive has signed a full release of all claims, the executive will be entitled to receive:
+Added: (i) severance pay equal to twelve months of his or her then-current base salary (currently estimated at approximately $ 1,331,000 in the aggregate), and (ii) a reimbursement for health insurance benefits under COBRA for the executive and his or her spouse and dependents for a period of twelve months or until the executive becomes eligible for comparable insurance benefits from another employer, whichever is earlier.
+Added: Operating Leases
+Added: The Company leases 953 square feet of office space in Reno, Nevada for research and development activities from a company owned by the Company’s former Vice President of Research and Development.
+Added: The lease, as amended, expires on September 14, 2022 and provides for lease payments of $ 5,404 per month and a security deposit in the amount of $ 5,404 .
+Added: Since the inception of the lease, the Company has made $ 112,600 of leasehold improvements related to this lease which are included in property and equipment, net on the accompanying balance sheets.
+Added: The Company’s rent expense amounted to $ 17,095 and $ 17,020 for the three months ended March 31, 2022 and 2021, respectively.
Litigations, Claims and Assessments
1 unchanged sentence
The Company records legal costs associated with loss contingencies as incurred and accrues for all probable and estimable settlements.
−Removed: Arctic Vision License Agreement
−Removed: On August 10, 2020, the Company entered into the Arctic Vision License Agreement pursuant to which Arctic Vision may develop and commercialize MicroPine for the treatment of progressive myopia and MicroLine for the treatment of presbyopia in Greater China (mainland China, Hong Kong, Macau and Taiwan) and South Korea.
−Removed: EYENOVIA, INC.
−Removed: NOTES TO CONDENSED FINANCIAL STATEMENTS
−Removed: Under the terms of the Arctic Vision License Agreement, the Company received a non-refundable, upfront payment of $ 4.0 million, before any payments to Senju Pharmaceutical Co., Ltd.
−Removed: (“Senju”), due under the Exclusive License Agreement between the Company and Senju, as amended on April 8, 2020 and a Letter Agreement dated August 10, 2020 (the “Senju License Agreement”).
−Removed: The Company had recorded the $ 4.0 million payment as a deferred license fee until the payment is earned.
−Removed: The Company considers payment earned once certain trial data has been fully submitted to Arctic Vision, permitting Arctic Vision to seek regulatory approval with the National Medical Products Administration of China.
−Removed: The trial data for one of the two products (MicroPine) was fully submitted to Arctic Vision in March 2021.
−Removed: As a result, the Company recognized $ 2.0 million of deferred license fees (one-half of the $ 4.0 million upfront license fee) and recognized $ 0.8 million of deferred license costs related to the Senju payment during the three months ended March 31, 2021.
−Removed: The trial data for the other product (MicroLine) was fully submitted to Arctic Vision in June 2021.
−Removed: As a result, the Company recognized the remaining $ 2.0 million of deferred license fees and recognized the remaining $ 0.8 million of deferred license costs related to the Senju payment during the three months ended June 30, 2021.
−Removed: In addition, the Company may receive up to a total of $ 43.75 million in additional payments, based on various development and regulatory milestones, including the initiation of clinical research and regulatory approvals in Greater China and South Korea (up to $ 39.75 million), and development costs (up to $ 4.0 million).
−Removed: In December 2020, the Company satisfied a performance obligation which resulted in the Company recognizing $ 2.0 million of milestone revenues, pursuant to the Arctic Vision License Agreement.
−Removed: The $ 2.0 million was received from Arctic Vision in December 2020.
−Removed: The milestone revenue referred to above includes $ 2.0 million related to the MicroStat product resulting from Amendment 1 to the Arctic Vision License Agreement.
−Removed: On September 14, 2021, the Company and Arctic Vision executed this amendment which provides for a one-time upfront payment of $ 250,000 and milestone payments of $ 2.0 million based on the achievement of filing for and receiving regulatory approval separately from China and South Korea for the MicroStat Product.
−Removed: The Company anticipates the Marketing Authorization Application (MAA) filings to occur in December 2023 and the receipt of regulatory approval to occur in December 2024.
−Removed: The Company didn’t recognize revenue for the $ 250,000 upfront payment because it was passed through to Senju.
−Removed: See Note 8 - Related Party Transactions for additional information.
−Removed: Arctic Vision also will purchase its supply of MicroPine, MicroLine and MicroStat from the Company or, for such products not supplied by the Company, pay the Company a mid-single digit percentage royalty on net sales of such products, subject to certain adjustments.
−Removed: No royalty payments were earned through September 30, 2021.
−Removed: The Company will pay a mid-double digit percentage of such payments, royalties, or net proceeds of such supply to Senju pursuant to the Senju License Agreement.
−Removed: See Note 8 – Related Party Transactions- Senju License Agreement for additional details.
−Removed: Bausch License Agreement
−Removed: On October 9, 2020, the Company entered into the Bausch License Agreement pursuant to which Bausch Health may develop and commercialize the Bausch Licensed Product in the Licensed Territory.
−Removed: In connection with the Bausch License Agreement, Bausch Health paid the Company a non-refundable, upfront payment of $ 10.0 million.
−Removed: The Company has recorded this payment as a deferred license fee until the payment is earned.
−Removed: The Company will consider payment earned once certain administrative functions are transferred to Bausch Health, permitting Bausch Health to assume supervisory oversight of the ongoing MicroPine study (the CHAPERONE study).
−Removed: The upfront payment has not been earned as of September 30, 2021.
−Removed: Bausch Health could also pay the Company up to an aggregate of approximately $ 35.0 million in additional payments, depending on the achievement of certain regulatory and launch-based milestones.
−Removed: No milestone payments were earned through September 30, 2021.
−Removed: Under the terms of the Bausch License Agreement, on a country-by-country basis and Bausch Licensed Product-by- Bausch Licensed Product basis, Bausch Health will pay the Company royalties on a tiered basis (ranging from mid-single digit to mid-teen percentages) on gross profits from the sales of the Bausch Licensed Product in the Licensed Territory, subject to certain adjustments in the event of generic entry, negative gross profits or patent expiration, for a period of the later to occur of the 10th anniversary of the first commercial sale of a Bausch Licensed Product in such country in the Licensed Territory or the expiration of the last valid patent claim for a Bausch Licensed Product in such country in the Licensed Territory.
−Removed: No royalty payments were earned through September 30, 2021.
+Added: Note 8 – Stockholders’ Equity
+Added: At-The-Market Offerings
+Added: December 2021 Sales Agreement
+Added: On December 14, 2021, the Company entered into a Sales Agreement (the “December 2021 Sales Agreement”) with SVB Leerink under which the Company may offer and sell, from time to time at its sole discretion, shares of common stock for gross proceeds of up to $ 50.0 million through SVB Leerink as its sales agent (the “At-the-Market Offering”).
+Added: The Company’s prior sales agreement, with SVB Leerink, entered into in May 2021, was terminated upon the effectiveness of the December 2021 Sales Agreement.
+Added: The issuance and sale of shares, if any, of common stock by the Company under the December 2021 Sales Agreement will be pursuant to the Company’s Registration Statement on Form S-3 (File No.
+Added: 333-261638) filed with the SEC on December 14, 2021 (the “Registration Statement”), and the prospectus relating to the At-the-Market Offering filed therewith that forms a part of the Registration Statement.
+Added: Subject to the terms and conditions of the December 2021 Sales Agreement, SVB Leerink may sell the common stock by any method permitted by law deemed to be an “at –the- market offering” as defined in Rule 415(a)(4) of the Securities Act of 1933, as amended.
+Added: SVB Leerink will use commercially reasonable efforts to sell the common stock from time to time, based upon instructions from the Company (including any price, time or size limits or other customary parameters or conditions the Company may impose).
+Added: The Company will pay SVB Leerink a commission equal to three percent ( 3.0 )% of the gross sales proceeds of any common stock sold through SVB Leerink under the December 2021 Sales Agreement, and also has provided SVB Leerink with certain indemnification rights.
EYENOVIA, INC.
NOTES TO CONDENSED FINANCIAL STATEMENTS
−Removed: Note 8 – Related Party Transactions
−Removed: Lease Agreements
−Removed: The Company’s Vice President of Research and Development and Manufacturing (“VP of R&D”) owns a company that entered into a lease agreement with the Company on September 15, 2016 to lease 953 square feet of space located in Reno, NV with respect to its research and development activities.
−Removed: The initial monthly base rent was $ 3,895 per month over the term of the lease and the security deposit was $ 3,895 .
−Removed: On September 15, 2018, the Company amended the lease agreement to extend it until September 14, 2020 and increase the monthly base rent and security deposit to $ 4,012 .
−Removed: The lease agreement was amended again on April 6, 2020 to lease additional space and increase the monthly base rent and security deposit to $ 5,247 .
−Removed: On September 15, 2020, the Company agreed to extend the lease term until September 14, 2022 and increase the monthly base rent and security deposit to $ 5,404 .
−Removed: The Company made $ 122,298 of leasehold improvements related to this lease which are included on the balance sheet.
−Removed: The Company’s rent expense amounted to $ 16,212 and $ 15,982 for the three months ended September 30, 2021 and 2020, respectively, and $ 48,636 and $ 43,512 for the nine months ended September 30, 2021 and 2020, respectively.
−Removed: Senju License Agreement
−Removed: During 2015, the Company entered into an Exclusive License Agreement with Senju whereby the Company agreed to grant to Senju an exclusive, royalty-bearing license for its microdose product candidates for Asia to sublicense, develop, make, have made, manufacture, use, import, market, sell, and otherwise distribute the microdose product candidates.
−Removed: In consideration for the license, Senju agreed to pay to Eyenovia five percent ( 5 %) royalties for the term of the license agreement.
−Removed: The agreement will continue in full force and effect, on a country-by-country basis, until the latest to occur of:
−Removed: (i) the tenth (10th) anniversary of the first commercial sale of a microdose product candidate in Asia;
−Removed: or (ii) the expiration of the licensed patents.
−Removed: As of the date of this filing, there had been no commercial sales of a microdose product candidate in Asia, such that no royalties had been earned.
−Removed: Senju is owned by the family of a former member of the Company’s Board of Directors and, together, they beneficially own greater than 5 % of the Company’s common stock.
−Removed: On April 8, 2020, the Company entered into an amendment (the “License Amendment”) to the Exclusive License Agreement.
−Removed: Pursuant to the License Amendment, the Company can license to any third party the right to research, develop, commercialize, manufacture or use certain products identified below (the “Senju Licensed Products”) previously licensed to Senju in China (including the People’s Republic of China, Hong Kong, Macao, and Taiwan) and South Korea (the “Territory”) if such a license was executed by the Company by April 8, 2021.
−Removed: The Senju Licensed Products are those using piezo-print technology in a microdose dispenser with (i) atropine sulfate as its sole active ingredient to treat myopia in humans and (ii) pilocarpine as its sole active ingredient to treat presbyopia in humans.
−Removed: Pursuant to the License Amendment, the Company must pay Senju (a) close to a mid-double digit percentage of revenue on any lump-sum payments the Company receives from the third party, revenue (net of costs) obtained by the Company from contract research and/or development of the Senju Licensed Product in the Territory, and revenue (net of costs) obtained by the Company from contract manufacture for the device of the Senju Licensed Product in the Territory, the aggregate of which must be at least a high seven figure dollar amount minimum payment to Senju;
−Removed: and (b) a lower-double digit percentage of any sales royalty revenue the Company receives from the third party.
−Removed: Since the Company executed a third-party license prior to April 8, 2021, the License Amendment will remain in effect for the duration of the license, subject to early termination.
−Removed: The Exclusive License Agreement was further amended in a Letter Agreement by and between the Company and Senju on August 10, 2020 (the “Letter Agreement”).
−Removed: Pursuant to the Letter Agreement, the Company will pay a mid-double digit percentage of certain payments, royalties, or net proceeds received from Arctic Vision in connection with the Arctic Vision License Agreement to Senju.
−Removed: The Exclusive License Agreement was amended further by the License Amendment 2, effective September 14, 2021 (the “Amendment 2”).
−Removed: The Amendment 2 excludes Greater China and South Korea from the territory in which Senju was granted an exclusive royalty-bearing license from the Company.
−Removed: In consideration for this exclusion, and upon and after the execution of Amendment 1 with Arctic Vision, the Company must make payments to Senju based on non-royalty license revenue and sales revenue, including a one-time upfront payment of $ 250,000 which represented an inducement to Senju to approve Amendment 1 of the Arctic Vision License Agreement related to the MicroStat product.
−Removed: This upfront payment to Senju was in addition to and separate from the previously established 40 % payment on milestone revenue.
−Removed: See Note 7 – Commitments and Contingencies – Arctic Vision License Agreement for additional details.
+Added: March 31, 2022, the Company received approximately $ 0.9 million in net proceeds from the sale of 252,449 shares of its common stock pursuant to the December 2021 Sales Agreement.
+Added: Securities Purchase Agreement
+Added: On March 3, 2022, the Company entered into a securities purchase agreement (the “Purchase Agreement”) with a certain institutional and accredited investor (the “Purchaser”), relating to the issuance and sale of 3,000,000 shares (the “Shares”) of common stock, pre-funded warrants (the “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 “Investor Warrants”) in a registered direct offering (the “March 2022 Offering”).
+Added: The Company determined that the warrants qualified for equity classification.
+Added: The offering price for the Shares was $ 3.08 per Share and the offering price for the Pre-Funded Warrants was $ 3.07 per Pre-Funded Warrant, which represents the per Share public offering price less $ 0.01 per share exercise price for each Pre-Funded Warrant.
+Added: The Investor Warrants have an exercise price of $ 3.54 per share and each Investor Warrant is exercisable for one share of common stock.
+Added: The Investor Warrants will be exercisable beginning six months from the date of issuance and the Pre-Funded Warrants are exercisable immediately upon issuance.
+Added: The Pre-Funded Warrants shall terminate when fully exercised and the Investor Warrants will terminate five years from the initial exercisability date.
+Added: The aggregate gross proceeds to the Company from the March 2022 Offering were approximately $ 15 million, excluding the proceeds, if any, from the exercise of the Pre-Funded Warrants and the Investor Warrants.
+Added: No underwriter or placement agent participated in the March 2022 Offering.
+Added: See Note 10 – Subsequent Events for additional information.
+Added: The March 2022 Offering was made pursuant to an effective registration statement on Form S-3 (Registration Statement No.
+Added: 333-261638), as previously filed with and declared effective by the Securities and Exchange Commission and a related prospectus.
+Added: Stock-Based Compensation Expense
+Added: The Company records stock-based compensation expense related to stock options and restricted stock units (“RSUs”).
+Added: For the three months ended March 31, 2022 and 2021, the Company recorded expense of $ 908,987 ($ 501,181 of which was included within research and development expenses and $ 407,806 was included within general and administrative expenses on the statements of operations) and $ 656,913 ($ 329,713 of which was included within research and development expenses and $ 327,200 was included within general and administrative expenses on the statements of operations), respectively.
+Added: Restricted Stock Units
+Added: A summary of the restricted stock units activity during the three months ended March 31, 2022 is presented below:
+Added: RSUs non-vested January 1, 2022
+Added: RSUs non-vested March 31, 2022
+Added: Vested RSUs undelivered March 31, 2022
+Added: To date, the RSUs have only been granted to directors in accordance with the Company’s Amended and Restated 2018 Omnibus Stock Incentive Plan.
+Added: The Company’s policy is not to deliver shares underlying the RSUs until the termination of service.
+Added: As of March 31, 2022, there was $ 54,688 of unrecognized stock-based compensation expense related to RSUs which will be recognized over a weighted average period of 0.6 years.
EYENOVIA, INC.
NOTES TO CONDENSED FINANCIAL STATEMENTS
−Removed: Note 9 – Stockholders’ Equity
−Removed: Securities Purchase Agreement
−Removed: On March 24, 2020, the Company closed on a private placement of approximately $ 6.0 million of Units.
−Removed: Each Unit consists of (i) one share of the Company’s common stock, (ii) a one-year warrant to purchase 0.5 of a share of common stock (“Class A Warrant”), and (iii) a five-year warrant to purchase 0.75 of a share of common stock (“Class B Warrant”) (collectively, the Class A Warrants and Class B Warrants, the “Warrants”).
−Removed: The Units were sold to the public at a price of $ 2.21425 per Unit and to certain directors and executive officers at a price of $ 2.42625 per Unit.
−Removed: The Company generated approximately $ 5.45 million of net proceeds in the offering after deducting placement agent fees and offering expenses of $ 0.53 million.
−Removed: In the offering, the Company issued an aggregate of 2,675,293 shares of common stock, Class A Warrants to purchase up to 1,337,659 shares of common stock, and Class B Warrants to purchase up to 2,006,495 shares of common stock.
−Removed: The exercise price of the Class A Warrants issued to the public is $ 2.058 per share and the exercise price of the Class A Warrants issued to the directors and officers is $ 2.27 per share.
−Removed: The exercise price of the Class B Warrants issued to the public is $ 2.4696 per share and the exercise price of the Class B Warrants issued to the directors and officers is $ 2.724 per share.
−Removed: See “Warrants” below for additional details.
−Removed: In connection with the private placement, on March 23, 2020, the Company also entered into a Registration Rights Agreement with the investors.
−Removed: Pursuant to the Registration Rights Agreement, the Company agreed to file with the SEC, no later than 30 days following the date on which the Company files its Form 10-K for the year ended December 31, 2019 with the SEC, a registration statement on Form S-3 covering the shares of common stock issued in the offering and the shares of common stock underlying the Warrants.
−Removed: The Company timely filed the registration statement on Form S-3 (Registration Statement No.
−Removed: 333-237790), which was declared and has remained effective with the SEC since May 13, 2020.
Stock Options
1 unchanged sentence
For the Three Months Ended
−Removed: For the Nine Months Ended
−Removed: September 30,
−Removed: September 30,
Expected term (years)
1 unchanged sentence
0.76 % - 1.98 %
−Removed: 0.45 % - 1.58 %
−Removed: 0.26 % - 1.32 %
Expected volatility
8 unchanged sentences
Treasury zero-coupon bonds with a remaining term consistent with the expected term of the instrument being valued.
−Removed: The weighted average estimated grant date fair value of the stock options granted for the three months ended September 30, 2021 and 2020 was approximately $ 3.56 and $ 2.71 per share, respectively.
−Removed: The weighted average estimated grant date fair value of the stock options granted for the nine months ended September 30, 2021 and 2020 was approximately $ 4.16 and $ 2.24 per share, respectively.
−Removed: On June 17, 2021, an employee exercised an option to purchase common shares on a cashless basis, which resulted in 13,675 shares being withheld and not issued, to cover the cost to exercise and all payroll taxes.
+Added: The weighted average estimated grant date fair value of the stock options granted for the three months ended March 31, 2022 and 2021 were approximately $ 2.28 and $ 3.82 per share, respectively.
+Added: A summary of the option activity during the three months ended March 31, 2022 is presented below:
+Added: Outstanding, January 1, 2022
+Added: Outstanding March 31, 2022
+Added: Exercisable March 31, 2022
EYENOVIA, INC.
NOTES TO CONDENSED FINANCIAL STATEMENTS
−Removed: A summary of the option activity during the nine months ended September 30, 2021 is presented below:
−Removed: Outstanding January 1, 2021
−Removed: Outstanding September 30, 2021
−Removed: Exercisable September 30, 2021
−Removed: The following table presents information related to stock options as of September 30, 2021:
+Added: The following table presents information related to stock options as of March 31, 2022:
Options Outstanding
1 unchanged sentence
Remaining Life
−Removed: Restricted Stock Units
−Removed: On September 11, 2020 and March 31, 2021, the Company granted members of its Board of Directors an aggregate of 44,951 RSUs under its Amended and Restated 2018 Omnibus Stock Incentive Plan.
−Removed: Each RSU is subject to settlement into one share of the Company’s common stock.
−Removed: The RSUs provided that vesting would occur on the earlier of (i) the one-year anniversary of the date of grant and (ii) the date of the 2021 annual stockholders meeting, subject to the grantee remaining on the Board until then.
−Removed: The 2021 annual stockholders meeting took place on June 16, 2021 which triggered the vesting of the RSUs.
−Removed: The RSUs had an aggregate grant date fair value of $ 156,200 , which was recognized over the vesting period.
−Removed: Pursuant to the terms of the grants, vested RSUs are not issued until (a) termination of the director’s service to the Company;
−Removed: or (b) upon a change-of-control transaction (as specified).
+Added: As of March 31, 2022, there was $ 5,295,408 of unrecognized stock-based compensation expense related to stock options which will be recognized over a weighted average period of 1.9 years.
+Added: A summary of the warrant activity for the three months ended March 31, 2022 is presented below:
+Added: Outstanding January 1, 2022
+Added: Outstanding March 31, 2022
+Added: Exercisable March 31, 2022
EYENOVIA, INC.
NOTES TO CONDENSED FINANCIAL STATEMENTS
−Removed: Stock-Based Compensation Expense
−Removed: The Company recorded stock-based compensation expense related to stock options and RSUs.
−Removed: During the three months ended September 30, 2021 and 2020, the Company recorded expense of $ 777,467 ($ 489,121 of which was included within research and development expenses and $ 288,346 of which was included within general and administrative expenses on the condensed statement of operations) and $ 609,930 ($ 346,294 of which was included within research and development expenses and $ 263,636 of which was included within general and administrative expenses on the condensed statement of operations), respectively.
−Removed: During the nine months ended September 30, 2021 and 2020, the Company recorded expense of $ 2,071,735 ($ 1,138,331 of which was included within research and development expenses and $ 933,404 was included within general and administrative expenses on the condensed statement of operations) and $ 1,826,941 ($ 1,002,150 of which was included within research and development expenses and $ 824,791 was included within general and administrative expenses on the condensed statement of operations), respectively.
−Removed: As of September 30, 2021, there was $ 5,787,351 of unrecognized stock-based compensation expense which the Company expects to recognize over a weighted average period of 2.1 years.
−Removed: A summary of warrant activity for the nine months ended September 30, 2021 is presented below:
−Removed: Outstanding January 1, 2021
−Removed: Outstanding September 30, 2021
−Removed: Exercisable September 30, 2021
−Removed: The following table presents information related to Warrants as of September 30, 2021:
+Added: The following table presents information related to warrants as of March 31, 2022:
Warrants Outstanding
1 unchanged sentence
Remaining Life
−Removed: See Note 6 – Notes Payable – for details on the warrant issued in connection with the SVB loan.
−Removed: During the three months ended September 30, 2020, warrants for the purchase of 1,080,497 shares of the Company’s common stock, with exercise prices of either $ 2.058 or $ 2.4696 per share, were exercised for aggregate proceeds of approximately $ 2.3 million, while no warrants were exercised during the three months ended September 30, 2021.
−Removed: During the nine months ended September 30, 2021 and 2020, warrants for the purchase of 877,014 and 1,248,161 shares of the Company’s common stock, respectively, with exercise prices of either $ 2.058 or $ 2.4696 per share, were exercised for aggregate proceeds of approximately $ 2.1 million and $2.6 million, respectively.
−Removed: At-The-Market Offering
−Removed: On May 14, 2021, the Company entered into a Sales Agreement (the “Agreement”) with SVB Leerink LLC (“SVB Leerink”) under which the Company may offer and sell, from time to time at its sole discretion, shares of its common stock (the “Common Stock”), having an aggregate offering price of up to $ 30 million through SVB Leerink as its sales agent.
−Removed: Subject to the terms and conditions of
−Removed: EYENOVIA, INC.
−Removed: NOTES TO CONDENSED FINANCIAL STATEMENTS
−Removed: the Agreement, SVB Leerink may sell the Common Stock by any method permitted by law deemed to be an “at-the-market offering”.
−Removed: SVB Leerink will use commercially reasonable efforts to sell the Common Stock from time to time, based upon instructions from the Company (including any price, time or size limits or other customary parameters or conditions the Company may impose).
−Removed: The Company will pay SVB Leerink a commission equal to three percent ( 3.0 %) of the gross sales proceeds of any Common Stock sold through SVB Leerink under the Agreement.
−Removed: The Company is not obligated to make any sales of Common Stock under the Agreement.
−Removed: through September 30, 2021, the Company had not sold any shares of common stock under the Agreement.
−Removed: See Note 11 - Subsequent Events - At-The-Market Offering for additional details.
Note 9 – Employee Benefit Plans
3 unchanged sentences
For 2022 and 2021, the Company’s Board of Directors has approved a matching contribution equal to 100 % of elective deferrals up to 4 % of eligible earnings with the matching contribution subject to certain vesting requirements as outlined in the Plan documents.
−Removed: During the three months ended September 30, 2021 and 2020, the Company recorded expense of $ 34,076 and $ 25,535 associated with its matching contributions, respectively.
−Removed: During the nine months ended September 30, 2021 and 2020, the Company recorded expense of $ 144,917 and $ 106,021 associated with its matching contributions, respectively.
+Added: During the three months ended March 31, 2022 and 2021, the Company recorded expense of $ 86,099 and $ 64,178 associated with its matching contributions, respectively.
Note 10 – Subsequent Events
−Removed: At-The-Market Offering
−Removed: Pursuant to the At-The-Market Offering (see Note 9 – Stockholders’ Equity – At-The-Market Offering) the Company commenced sales of its common stock on October 6, 2021.
−Removed: As of the filing date, the Company has received approximately $ 12.8 million in gross proceeds and $ 12.4 million in net proceeds from the sale of 2,435,604 shares of its common stock.
−Removed: MydCombi FDA Application
−Removed: On October 25, 2021, the Company announced the reclassification of the Company’s proprietary, first-in-class combination microdose formulation of tropicamide and phenylephrine for in-office pupil dilation, MydCombi, as a drug-device combination product by the FDA in a CRL received on October 22, 2021, following a change in the agency’s legal interpretation of its authorities imposed by a recent court ruling.
−Removed: The Company is preparing the necessary documents for expedited resubmission of the new drug application for MydCombi in response to the CRL.
−Removed: See Note 1 – Business Organization, Nature of Operations and Basis of Presentation and Note 6 – Notes Payable – Silicon Valley Bank Loan.
−Removed: Employee Stock Options
−Removed: On October 27, 2021, the Company granted ten-year stock options to employees, pursuant to its Amended and Restated 2018 Omnibus Stock Incentive Plan, to purchase an aggregate of 35,000 shares of the Company’s common stock at an exercise price of $ 4.06 per share.
−Removed: The options expire on the tenth anniversary of the grant date and they vest with respect to one -third of the shares underlying the awards on the first anniversary of the grant date and, with respect to the remaining two -thirds of the shares underlying the awards, in equal monthly installments over the subsequent two years .
+Added: The Company has evaluated events that have occurred after the balance sheet date and through the date 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 below.
+Added: SVB Loan Amendment
+Added: On May 6, 2022, the Company and SVB agreed to amend the terms of the SVB Loan dated May 7, 2021.
+Added: Pursuant to the amendment, the repayment term of the SVB Loan is reduced to 24 consecutive calendar months and the date that the first payment is due by the Company is extended to June 1, 2023.
+Added: Warrant Exercises
+Added: Subsequent to March 31, 2022, the Company issued an aggregate of 1,870,130 shares of the Company’s common stock pursuant to the exercise of the Pre-Funded Warrants at an exercise price of $ 0.01 per share for aggregate gross proceeds of $ 18,701 .
+Added: See Note 8 – Stockholders’ Equity – Securities Purchase Agreement and Note 8 – Stockholders’ Equity - Warrants for additional information.
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.