UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
WASHINGTON, DC 20549

 

 

FORM 10-Q

 

 

xQUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934

 

For the quarterly period ended:September 30, 20192020

 

OR

 

¨TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934

 

For the transition period from _________________ to ______________________

 

COMMISSION FILE NUMBER:001-38365

 

 

EYENOVIA, INC.


(Exact name of Registrant as Specified in Its Charter)

 

 

DELAWARE 47-1178401
(State or Other Jurisdiction of
Incorporation or Organization)
 (I.R.S. Employer
Identification No.)
   
295 Madison Avenue, Suite 2400
NEW YORK, NY
 

 

10017

(Address of Principal Executive Offices) (Zip Code)

 

Registrant’s telephone number, including area code:(917) 289-1117

 

 

 

Securities registered pursuant to Section 12(b) of the Act:

 

Title of each classTrading Symbol(s)Name of each exchange on which registered
Common Stock, $0.0001 Par ValueEYENNasdaq Capital Market

 

Indicate by check mark whether the registrant: (1) has filed all reports required to be filed by Section 13 or 15(d) of the Securities Exchange Act of 1934 during the preceding 12 months (or for such shorter period that the registrant was required to file such reports), and (2) has been subject to such filing requirements for the past 90 days. YesxNo¨

 

Indicate by check mark whether the registrant has submitted electronically every Interactive Data File required to be submitted pursuant to Rule 405 of Regulation S-T (§232.405 of this chapter) during the preceding 12 months (or for such shorter period that the registrant was required to submit such files). YesxNo¨

 

Indicate by check mark whether the registrant is a large accelerated filer, an accelerated filer, a non-accelerated filer, a smaller reporting company, or an emerging growth company. See the definitions of “large accelerated filer,” “accelerated filer,” “smaller reporting company,” and “emerging growth company” in Rule 12b-2 of the Exchange Act.

 

Large accelerated filer¨Accelerated filer¨
  
Non-accelerated filerxSmaller reporting companyx
  
 Emerging growth companyx

 

If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any news or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act.¨

 

Indicate by check mark whether the registrant is a shell company (as defined in Rule 12b-2 of the Act). Yes¨Nox

 

The number of outstanding shares of the registrant’s common stock was 17,100,72624,884,251 as of November 8, 2019.10, 2020.

 

 

 

 

EYENOVIA, INC.

 

FORM 10-Q

 

FOR THE QUARTERLY PERIOD ENDED SEPTEMBER 30, 20192020

 

TABLE OF CONTENTS

 

PART I - FINANCIAL INFORMATION 
  
Item 1. Financial Statements.2
  
Condensed Balance Sheets as of September 30, 20192020 (Unaudited) and December 31, 201820192
  
Unaudited Condensed Statements of Operations for the Three and Nine Months Ended September 30, 20192020 and 201820193
  
Unaudited Condensed Statements of Changes in Stockholders' Equity for the  Nine Months Ended September 30, 20192020 and 201820194
  
Unaudited Condensed Statements of Cash Flows for the Nine Months Ended September 30, 20192020 and 201820195
  
Notes to Unaudited Condensed Financial Statements6
  
Item 2. Management’s Discussion and Analysis of Financial Condition and Results of Operations.1419
  
Item 3. Quantitative and Qualitative Disclosures About Market Risk.1823
  
Item 4. Controls and Procedures.1823
  
PART II - OTHER INFORMATION 
  
Item 1. Legal Proceedings.1925
  
Item 1A. Risk Factors.1925
  
Item 2. Unregistered Sales of Equity Securities and Use of Proceeds.1925
  
Item 3. Defaults Upon Senior Securities.1925
  
Item 4. Mine Safety Disclosures.1925
  
Item 5. Other Information.1925
  
Item 6. Exhibits.2026
  
SIGNATURES2127

 


PART I – FINANCIAL INFORMATION

 

Item 1. Financial Statements.

 

EYENOVIA, INC.

 

Condensed Balance Sheets

 

 September 30, December 31,  September 30, December 31, 
 2019  2018  2020  2019 
 (unaudited)     (unaudited)   
Assets                
                
Current Assets:                
Cash and cash equivalents $18,295,962  $19,728,200  $22,864,578  $14,152,601 
Deferred license costs  1,600,000   - 
Prepaid expenses and other current assets  396,977   132,756   903,090   196,680 
                
Total Current Assets  18,692,939   19,860,956   25,367,668   14,349,281 
                
Property and equipment, net  71,722   36,738   360,956   230,538 
Security deposit  117,800   117,800   119,035   117,800 
                
Total Assets $18,882,461  $20,015,494  $25,847,659  $14,697,619 
                
Liabilities and Stockholders' Equity                
                
Current Liabilities:                
Accounts payable $1,595,270  $1,509,524  $1,464,762  $1,541,358 
Accrued compensation  591,494   912,104   744,555   916,873 
Accrued expenses and other current liabilities  246,374   677,213   373,609   453,430 
Deferred rent - current portion  7,809   - 
Deferred license fee  4,000,000   - 
Notes payable - current portion  145,942   - 
                
Total Current Liabilities  2,433,138   3,098,841   6,736,677   2,911,661 
                
Deferred rent  45,354   41,584 
Deferred rent - non-current portion  36,423   45,351 
Notes payable - non-current portion  424,338   - 
                
Total Liabilities  2,478,492   3,140,425   7,197,438   2,957,012 
                
Commitments and contingencies (Note 6)        
Commitments and contingencies (Note 7)        
                
Stockholders' Equity:                
Preferred stock, $0.0001 par value, 6,000,000 shares authorized; 0 shares issued and outstanding as of September 30, 2019 and as of December 31, 2018  -   - 
Common stock, $0.0001 par value, 90,000,000 shares authorized; 17,100,726 and 11,468,996 shares issued and outstanding as of September 30, 2019 and December 31, 2018, respectively  1,710   1,147 
Preferred stock, $0.0001 par value, 6,000,000 shares authorized;        
0 shares issued and outstanding as of September 30, 2020 and        
as of December 31, 2019  -   - 
Common stock, $0.0001 par value, 90,000,000 shares authorized;        
24,884,251 and 17,100,726 shares issued and outstanding        
as of September 30, 2020 and December 31, 2019, respectively  2,488   1,710 
Additional paid-in capital  68,831,827   53,388,216   91,881,790   69,409,949 
Accumulated deficit  (52,429,568)  (36,514,294)  (73,234,057)  (57,671,052)
                
Total Stockholders' Equity  16,403,969   16,875,069   18,650,221   11,740,607 
                
Total Liabilities and Stockholders' Equity $18,882,461  $20,015,494  $25,847,659  $14,697,619 

 

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

 


EYENOVIA, INC.

 

Condensed Statements of Operations

(unaudited)

 

 For the Three Months Ended For the Nine Months Ended  For the Three Months Ended For the Nine Months Ended
 September 30,  September 30,  September 30, September 30,
 2019  2018  2019  2018  2020 2019 2020 2019 
Operating Expenses:                         
Research and development $3,201,196  $2,487,573  $10,778,114  $6,993,832  $3,363,759 $3,201,196 $9,913,296 $10,778,114 
General and administrative  1,489,739   1,832,794   5,241,608   4,079,249   1,728,366  1,489,739  5,669,311  5,241,608 
                         
Total Operating Expenses  4,690,935   4,320,367   16,019,722   11,073,081   5,092,125  4,690,935  15,582,607  16,019,722 
                         
Loss From Operations  (4,690,935)  (4,320,367)  (16,019,722)  (11,073,081) (5,092,125) (4,690,935) (15,582,607) (16,019,722)
                         
Other Income (Expense):                         
Interest income (expense)  41,557   (964)  104,448   3,080 
Small Business Administration Economic Injury Disaster grant - - 10,000 - 
Interest expense (4,945) - (14,977) - 
Interest income  540  41,557  24,579  104,448 
                         
Net Loss $(4,649,378) $(4,321,331) $(15,915,274) $(11,070,001) $(5,096,530) $(4,649,378) $(15,563,005) $(15,915,274)
                         
Net Loss Per Share                
- Basic and Diluted $(0.29) $(0.43) $(1.19) $(1.20)
Net Loss Per Share - Basic and Diluted $(0.23) $(0.29) $(0.79) $(1.19)
                         
Weighted Average Number of Common Shares Outstanding                
- Basic and Diluted  16,270,728   10,030,296   13,422,667   9,219,818 
Weighted Average Number of Common Shares Outstanding - Basic and Diluted  22,206,195  16,270,728  19,802,999  13,422,667 

 

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

 


EYENOVIA, INC.

 

Condensed Statements of Changes in Stockholders’ Equity

(unaudited)

  For the Nine Months Ended September 30, 2020 
        Additional     Total 
  Common Stock  Paid-In  Accumulated  Stockholders' 
  Shares  Amount  Capital  Deficit  Equity 
Balance - January 1, 2020  17,100,726  $1,710  $69,409,949  $(57,671,052) $11,740,607 
Issuance of common stock and warrants in private placement [1]  2,675,293   267   5,451,475   -   5,451,742 
Stock-based compensation  -   -   583,865   -   583,865 
Net loss  -   -   -   (5,450,910)  (5,450,910)
Balance - March 31, 2020  19,776,019   1,977   75,445,289   (63,121,962)  12,325,304 
Exercise of stock warrants  167,664   17   376,404   -   376,421 
Stock-based compensation  -   -   633,146   -   633,146 
Net loss  -   -   -   (5,015,565)  (5,015,565)
Balance - June 30, 2020  19,943,683   1,994   76,454,839   (68,137,527)  8,319,306 
Issuance of common stock in public offering [2]  3,833,334   383   12,495,325   -   12,495,708 
Exercise of stock warrants  1,080,497   108   2,269,562   -   2,269,670 
Exercise of stock options  26,737   3   52,134   -   52,137 
Stock-based compensation  -   -   609,930   -   609,930 
Net loss  -   -   -   (5,096,530)  (5,096,530)
Balance - September 30, 2020  24,884,251  $2,488  $91,881,790  $(73,234,057) $18,650,221 

[1] Includes gross proceeds of $5,984,931, less total issuance costs of $533,189.

[2] Includes gross proceeds of $13,800,002, less total issuance costs of $1,304,294.

 

  For the Nine Months Ended September 30, 2019 
        Additional     Total 
  Common Stock  Paid-In  Accumulated  Stockholders' 
  Shares  Amount  Capital  Deficit  Equity 
Balance - January 1, 2019  11,468,996  $1,147  $53,388,216  $(36,514,294) $16,875,069 
Exercise of stock options on a cashless basis  236,466   24   (24)  -   - 
Exercise of stock options  313,686   31   483,857   -   483,888 
Stock-based compensation  -   -   1,032,960   -   1,032,960 
Net loss  -   -   -   (5,932,384)  (5,932,384)
Balance - March 31, 2019  12,019,148   1,202   54,905,009   (42,446,678)  12,459,533 
Exercise of stock options  34,815   3   67,886   -   67,889 
Stock-based compensation  -   -   424,019   -   424,019 
Net loss  -   -   -   (5,333,512)  (5,333,512)
Balance - June 30, 2019  12,053,963   1,205   55,396,914   (47,780,190)  7,617,929 
Issuance of common stock in public offering [1]  5,046,763   505   12,958,070   -   12,958,575 
Stock-based compensation  -   -   476,843   -   476,843 
Net loss  -   -   -   (4,649,378)  (4,649,378)
Balance - September 30, 2019  17,100,726  $1,710  $68,831,827  $(52,429,568) $16,403,969 

 

[1] Includes gross proceeds of $14,030,001, less total issuance costs of $1,071,931.

 

  For the Nine Months Ended September 30, 2018 
  Convertible Preferred Stock        Additional     Total 
  Series A  Series A-2  Series B  Common Stock  Paid-In  Accumulated  Stockholders' 
  Shares  Amount  Shares  Amount  Shares  Amount  Shares  Amount  Capital  Deficit  Equity 
Balance - January 1, 2018  2,932,431  $293   788,827  $79   918,983  $92   2,566,530  $257  $24,351,138  $(19,261,186) $5,090,673 
                                             
Conversion of convertible preferred stock into common stock upon completion of initial public offering  (2,932,431)  (293)  (788,827)  (79)  (918,983)  (92)  4,640,241   464       -   - 
                                             
Issuance of common stock in initial public offering [2]  -   -   -   -   -   -   2,730,000   273   24,547,530   -   24,547,803 
                                             
Stock-based compensation  -   -   -   -   -   -   -   -   650,576   -   650,576 
                   -                       - 
Net loss  -   -   -   -   -   -   -   -   -   (3,429,607)  (3,429,607)
                                             
Balance - March 31, 2018  -   -   -   -   -   -   9,936,771   994   49,549,244   (22,690,793)  26,859,445 
                                             
Conversion of convertible preferred stock into common stock upon completion of initial public offering  -   -   -   -   -   -   61,875   6   (6)  -   - 
                                             
Stock-based compensation  -   -   -   -   -   -   -   -   1,512   -   1,512 
                                             
Net loss  -   -   -   -   -   -   -   -   -   (3,319,063)  (3,319,063)
                                             
Balance - June 30, 2018  -   -   -   -   -   -   9,998,646   1,000   49,550,750   (26,009,856)  23,541,894 
                                             
Exercise of warrants on a cashless basis  -   -   -   -   -   -   61,385   6   (6)  -   - 
                                             
Exercise of stock options  -   -   -   -   -   -   28,965   3   56,479   -   56,482 
                                             
Stock-based compensation  -   -   -   -   -   -   -   -   462,946   -   462,946 
                                             
Net loss  -   -   -   -   -   -   -   -   -   (4,321,331)  (4,321,331)
                                             
Balance - September 30, 2018  -  $-   -  $-   -  $-   10,088,996  $1,009  $50,070,169  $(30,331,187) $19,739,991 

[2] Includes gross proceeds of $27,300,000, less total issuance costs of $2,752,197.

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


EYENOVIA, INC.

 

Condensed Statements of Cash Flows

(unaudited)

 

 For the Nine Months Ended  For the Nine Months Ended 
 September 30,  September 30, 
 2019  2018  2020  2019 
Cash Flows From Operating Activities:        
Cash Flows From Operating Activities        
Net loss $(15,915,274) $(11,070,001) $(15,563,005) $(15,915,274)
Adjustments to reconcile net loss to net cash used in operating activities:                
Depreciation and amortization  8,494   16,808   71,628   8,494 
Stock-based compensation  1,933,822   1,115,034   1,826,941   1,933,822 
Changes in operating assets and liabilities:                
Prepaid expenses and other current assets  (264,221)  (261,301)  (231,194)  (264,221)
Deferred license costs  (1,600,000)  - 
Accounts payable  85,746   593,846   (76,596)  85,745 
Accrued compensation  (320,610)  -   (172,318)  (320,610)
Accrued expenses and other current liabilities  (430,839)  715,721   (106,471)  (430,838)
Deferred license fee  4,000,000   - 
Security deposit  -   (117,800)  (1,235)  - 
Deferred rent  3,770   2,332   (1,119)  3,770 
                
Net Cash Used In Operating Activities  (14,899,112)  (9,005,361)  (11,853,369)  (14,899,112)
        
Cash Flows From Investing Activities:        
Cash Flows From Investing Activities        
Purchases of property and equipment  (43,478)  -   (202,046)  (43,478)
        
Net Cash Used In Investing Activities  (43,478)  -   (202,046)  (43,478)
        
Cash Flows From Financing Activities:        
Cash Flows From Financing Activities        
Proceeds from sale of common stock in public offering [1]  -   13,214,949 
Proceeds from sale of common stock and warrants in private placement [2]  5,569,136   - 
Proceeds from sale of common stock in public offering [3]  12,734,002     
Proceeds from exercise of stock warrants  2,646,091   - 
Proceeds from PPP 7(a) Loan  463,353   - 
Repayments of notes payable  (368,289)  - 
Payment of public offering issuance costs  (329,038)  (256,374)
Proceeds from exercise of stock options  551,777   56,482   52,137   551,777 
Proceeds from sale of common stock in initial public offering [1]  -   25,089,000 
Payment of initial public offering issuance costs  -   (345,497)
Proceeds from sale of common stock in public offering [2]  13,214,949   - 
Payment of public offering issuance costs  (256,374)  - 
                
Net Cash Provided By Financing Activities  13,510,352   24,799,985   20,767,392   13,510,352 
        
Net (Decrease) Increase in Cash and Cash Equivalents  (1,432,238)  15,794,624 
        
Cash and Cash Equivalents - Beginning of Period  19,728,200   5,249,511 
        
Cash and Cash Equivalents - End of Period $18,295,962  $21,044,135 
Net Increase (Decrease) in Cash and Cash Equivalents  8,711,977   (1,432,238)
Cash and cash equivalents - Beginning of Period  14,152,601   19,728,200 
Cash and cash equivalents - End of Period $22,864,578  $18,295,962 

 

[1] Includes gross proceeds of $27,300,000, less issuance costs of $2,211,000 deducted directly from the offering proceeds.

[2] Includes gross proceeds of $14,030,001, less issuance costs of $815,052 deducted directly from the offering proceeds.

[2] Includes gross proceeds of $5,984,931, less issuance costs of $415,795 deducted directly from the private placement proceeds.

Supplemental Disclosures of Cash Flow Information:        
Cash paid during the periods for:        
Interest expense $-  $- 
Income taxes $-  $- 
Non-cash financing activities:        
Exercise of warrants on a cashless basis $-  $6 
Exercise of stock options on a cashless basis $24  $- 
Conversion of convertible preferred stock into common stock $-  $470 
Reversal of previously accrued initial public offering issuance costs $-  $(133,000)
Reduction of additional paid-in capital for initial public offering issuance costs that were previously paid $-  $(195,700)

[3] Includes gross proceeds of $13,800,002, less issuance costs of $1,066,000 deducted directly from the offering proceeds.

Supplemental Disclosure of Cash Flow Information:        
Cash paid during the periods for:        
Interest expense $7,961  $- 
Income taxes $-  $- 
Supplemental Disclosure of Non-Cash Investing and Financing Activities        
Accrual of public offering costs $(26,650) $- 
Purchase of insurance premium financed by note payable $(475,216) $- 
Exercise of stock options on a cashless basis $-  $24 

 

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


EYENOVIA, INC.

 

NOTES TO CONDENSED FINANCIAL STATEMENTS

 

(UNAUDITED)

 

Note 1 – Business Organization, Nature of Operations and Basis of Presentation

 

Eyenovia. Inc. (“Eyenovia” or the “Company”) is a clinical stage ophthalmic biopharmaceutical company developing a pipeline of microdose therapeutics utilizing its patented piezo-print delivery technology, branded the OptejetTM.array print (MAP™) therapeutics. 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. In the clinic, the Optejet has demonstrated upthe ability to horizontally deliver ophthalmic medication with a 75% reduction in ocular drug and preservative exposure, with successful topical deliverysuccess rate significantly higher than that is consistent with the efficacy of traditional eyedrop administration.eye drops (~ 90% vs. ~ 50%). Using its proprietary delivery technology, Eyenovia is developing the next generation of smart ophthalmic therapies while targetingwhich target new indications for whichor new combinations where there are currently no comparable drug therapies approved by the U.S. Food and Drug Administration (the “FDA”). Eyenovia’s microdose therapeutics follow the FDA-designated pharmaceutical registration and regulatory process. Its products are not classified by the FDA as drugs, and not medical devices or drug-device combination products.

 

The accompanying unaudited condensed financial statements have been prepared in accordance with accounting principles generally accepted in the United States of America (“U.S. GAAP”) for interim financial information and with the instructions to Form 10-Q and Article 8 of Regulation S-X. Accordingly, they do not include all of the information and disclosures required by U.S. GAAP for complete financial statements. In the opinion of management, such statements include all adjustments (consisting only of normal recurring items) which are considered necessary for a fair presentation of the condensed financial statements of the Company as of September 30, 20192020 and for the three and nine months ended September 30, 20192020 and 2018.2019. The results of operations for the three and nine months ended September 30, 20192020 are not necessarily indicative of the operating results for the full year ending December 31, 20192020 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, 20182019 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 Form 10-K on March 27, 2019.30, 2020.

 

Note 2 – Summary of Significant Accounting Policies

 

Since the date of the Company’s Annual Report on Form 10-K for the year ended December 31, 2019, there have been no material changes to the Company’s significant accounting policies, except as disclosed below.

 

Liquidity and Financial Condition

 

TheAs of September 30, 2020, the Company has not yet generated revenues or achieved profitabilityhad cash and expects to continue to incur cash outflows from operations. The Company expects that its researchequivalents of approximately $22.9 million and developmentan accumulated deficit of approximately $73.2 million. For the nine months ended September 30, 2020 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. On October 29, 2019, the Company announced that it is advancing its MicroLine program for the improvementincurred net losses of approximately $15.6 million and $15.9 million, respectively, and used cash in near vision in patients with presbyopia towards Phase III development. As a resultoperations of prioritizing MicroLine, in tandem with its Mircropine (progressive myopia)approximately $11.9 million and MicroStat (mydriasis) programs,$14.9 million, respectively. Subsequent to September 30, 2020, the Company has deferred development activitiesentered into a License Agreement (the “Bausch License Agreement”) with a subsidiary of Bausch Health Companies Inc. (“Bausch Health”) pursuant to which the Company received an upfront payment from Bausch Health of $10.0 million. See Note 11 – Subsequent Events for its MicroProst (glaucoma and ocular hypertension) and MicroTears (red eye and itch relief lubrication) programs. The Company believes the re-prioritization of its programs will yield overall cost savings of approximately $1.5 million to $1.9 million in 2020.details.

 

The Company believes its current cash on hand, including the proceeds received from public offerings following its initial public offering,the Bausch License Agreement and warrant exercises, is sufficient to meet its operating and capital requirements for at least the next twelve months from the date these financial statements are issued. Thereafter, the Company may need to raise further capital, through the sale of additional equity or debt securities, to support its future operations. The Company’s operating needs include the planned costs to operate its business, including amounts required to fund research and development activities including clinical studies, working capital and capital expenditures. The Company’s future capital requirements and the adequacy of its available funds will depend on many factors, including the Company’s ability to successfully manufacture its products and commercialize its products and services, competing technological and market developments, and the need to enter into collaborations with other companies or acquire other companies or technologies to enhance or complement its product and service offerings. If the Company is unable to secure additional capital, it may be required to curtail its research and development initiatives and take additional measures to reduce costs in order to conserve its cash.

 

6


EYENOVIA, INC.

 

NOTES TO CONDENSED FINANCIAL STATEMENTS

 

(UNAUDITED)

 

Note 2 – Summary of Significant Accounting Policies – Continued

 

Cash and Cash Equivalents

 

The Company considers all highly liquid investments with an original maturity of three months or less to be cash equivalents in the financial statements.

 

The Company has cash deposits and U.S. treasury bills 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. As of September 30, 20192020 and December 31, 2018,2019, the Company had cash and cash equivalent balances in excess of FDIC insurance limits of $18,045,962$22,614,578 and $19,478,200,$13,902,601, respectively.

 

Stock-Based CompensationDerivative Instruments

 

The Company measuresevaluates its embedded conversion options and any freestanding instruments to determine if those contracts or embedded components of those contracts qualify as derivative financial instruments to be separately accounted for in accordance with Topic 815 of the costFinancial Accounting Standards Board ("FASB") Accounting Standards Codification (“ASC”). The accounting treatment of services received in exchange for an awardderivative financial instruments requires that the Company record them at their fair values as of equity instruments based on the inception date of the agreement and at fair value as of each subsequent balance sheet date. Any change in fair value is recorded as non-operating, non-cash income or expense for each reporting period at each balance sheet date. The Company reassesses the classification of its derivative instruments at each balance sheet date. If the classification changes as a result of events during the period, the contract is reclassified as of the award. The fair valuedate of the award is measured onevent that caused the grant date and the fair value amount is then recognized over the period during which services are required to be provided in exchange for the award, usually the vesting period. Upon the exercise of an option, the Company issues new shares of common stock out of the shares reserved for issuance under its equity plans.reclassification.

 

Net Loss Per Common Share

 

Basic net loss per common share is computed by dividing net loss by the weighted average number of common shares outstanding during the period. 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:

 

 September 30,  September 30, 
 2019  2018  2020  2019 
Options  2,237,438   2,225,118   3,410,540   2,237,438 
Restricted Stock Units  60,355       20,165 
Warrants  2,095,993   - 
Restricted stock units  43,728   60,355 
Total potentially dilutive shares  2,297,793   2,245,283   5,550,261   2,297,793 


EYENOVIA, INC.

NOTES TO CONDENSED FINANCIAL STATEMENTS

(UNAUDITED)

Note 2 – Summary of Significant Accounting Policies – Continued

 

Recently Adopted Accounting Pronouncements

 

In August 2016,July 2017, the FASB issued ASU No. 2017-11, “Earnings Per Share (Topic 260) and Derivatives and Hedging (Topic 815)- Accounting for Certain Financial Accounting Standards Board (“FASB”) issued Accounting Standards Update (“ASU”) 2016-15, “Statement of Cash Flows (Topic 230) Classification of Certain Cash Receipts and Cash Payments”Instruments with Down Round Features” (“ASU 2016-15”2017-11”). The new standard will make eight targeted changes to how cash receiptsEquity-linked instruments, such as warrants and cash payments are presented and classifiedconvertible instruments may contain down round features that result in the strike price being reduced on the basis of the pricing of future equity offerings. Under ASU 2017-11, a down round feature will no longer require a freestanding equity-linked instrument (or embedded conversion option) to be classified as a liability that is remeasured at fair value through the income statement (i.e. marked-to-market). However, other features of cash flows.the equity-linked instrument (or embedded conversion option) must still be evaluated to determine whether liability or equity classification is appropriate. Equity classified instruments are not marked-to-market. For earnings per share ("EPS") reporting, the ASU requires companies to recognize the effect of the down round feature only when it is triggered by treating it as a dividend and as a reduction of income available to common shareholders in basic EPS. The new standard isamendments in this ASU are effective for all entities for fiscal years, and interim periods within those fiscal years, beginning after December 15, 2018. The new standard requires adoption on a retrospective basis unless it is impracticable to apply, in which case a company would be required to apply the amendments prospectively as of the earliest date practicable.2019. This standard, waswhich the Company adopted on January 1, 2019 and2020, did not have a material impact on the Company’s financial position, results of operations or cash flows.

 

In June 2018,March 2020, the FASB issued ASU No. 2018-07, “Compensation — Stock Compensation (Topic 718)”2020-03, “Codification Improvements to Financial Instruments” (“ASU 2018-07”2020-03”). ASU 2018-07 is2020-03 improves and clarifies various financial instruments topics. ASU 2020-03 includes seven different issues that describe the areas of improvement and the related amendments to GAAP, intended to reduce costmake the standards easier to understand and complexity of financial reporting for non-employee share-based payments. Currently, the accounting requirements for non-employeeapply by eliminating inconsistencies and employee share-based payments are significantly different.providing clarifications. The Company adopted ASU 2018-07 expands the scope of Topic 718,2020-03 upon issuance, which currently only includes share-based payments to employees, to include share-based payments to non-employees for goods or services. Consequently, the accounting for share-based payments to non-employees and employees will be substantially aligned. This ASU supersedes Subtopic 505-50, “Equity — Equity-Based Payments to Nonemployees.” The amendments to ASU 2018 - 07 are effective for fiscal years beginning after December 15, 2019, and interim periods within fiscal years beginning after December 15, 2020. Early adoption is permitted, but no earlier than a company’s adoption date of ASU No. 2014-09, (Topic 606), “Revenue from Contracts with Customers.” This standard was adopted on January 1, 2019 and did not have a material impact on the Company’s unaudited condensed financial position, results of operations or cash flows.statements.


EYENOVIA, INC.

NOTES TO CONDENSED FINANCIAL STATEMENTS

(UNAUDITED)

 

Note 3 – Prepaid Expenses and Other Current Assets

 

As of September 30, 20192020 and December 31, 2018,2019, prepaid expenses and other current assets consisted of the following:

 

 September 30, December 31,  September 30, December 31, 
 2019  2018  2020  2019 
 (unaudited)      (unaudited)     
Prepaid insurance expenses $152,940  $39,465  $271,866  $33,923 
Payroll tax credit receivable  85,932   - 
Payroll tax receivable  179,260   95,233 
Arctic Vision expense reimbursement receivable  149,675   - 
Prepaid research and development expenses  74,540   17,978 
Prepaid Board of Director fees  68,250   - 
Prepaid subscription fees  46,007   10,600 
Prepaid conference expenses  71,196   7,000   36,529   2,463 
Prepaid research & development expenses  25,528   - 
Prepaid rent and security deposit  31,945   - 
Prepaid patent expenses  19,848   10,562   29,499   12,404 
Prepaid advertising and marketing  16,400   - 
Prepaid rent and security deposit  16,213   75,729 
Other  8,920   -   15,519   24,079 
Total prepaid expenses and other current assets $396,977  $132,756  $903,090  $196,680 


EYENOVIA, INC.

NOTES TO CONDENSED FINANCIAL STATEMENTS

(UNAUDITED)

 

Note 4 – Accrued Compensation

 

As of September 30, 20192020 and December 31, 2018,2019, accrued compensation consisted of the following:

 

 September 30, December 31,  September 30, December 31, 
 2019  2018  2020  2019 
 (unaudited)     (unaudited)    
Accrued bonus expenses $516,360  $694,490  $579,604  $897,839 
Accrued payroll expenses  75,134   217,614   164,951   19,034 
Total accrued compensation $591,494  $912,104  $744,555  $916,873 

 

Note 5 – Accrued Expenses and Other Current Liabilities

 

As of September 30, 20192020 and December 31, 2018,2019, accrued expenses and other current liabilities consisted of the following:

 

  September 30,  December 31, 
  2020  2019 
  (unaudited)    
Accrued research and development expenses $294,421  $208,175 
Accrued public offering costs  14,102   - 
Accrued professional services  11,000   97,396 
Accrued legal expenses  14,195   - 
Accrued franchise tax  4,980   40,995 
Credit card payable  3,507   56,979 
Leasehold improvements  -   42,500 
Accrued travel and entertainment expenses  1,273   7,385 
Other  30,131   - 
Total accrued expenses and other current liabilities $373,609  $453,430 

  September 30,  December 31, 
  2019  2018 
  (unaudited)    
Accrued research and development expenses $150,139  $375,204 
Credit card payable  45,594   9,466 
Accrued franchise tax  34,246   - 
Accrued travel and entertainment expenses  10,728   - 
Accrued professional services  5,667   111,728 
Accrued legal expenses  -   168,650 
Other  -   12,165 
Total accrued expenses and other current liabilities $246,374  $677,213 

Note 6 – Notes Payable

As of September 30, 2020 and December 31, 2019, notes payable consisted of the following:

  September 30, 2020  December 31, 2019 
  (unaudited)    
  Current  Non-Current     Current  Non-Current    
  Portion  Portion  Total  Portion  Portion  Total 
Paycheck Protection Program loan $39,015  $424,338  $463,353  $-  $-  $- 
Directors and officers insurance policy loan  106,927   -   106,927   -   -   - 
Total $145,942  $424,338  $570,280  $-  $-  $- 

On February 24, 2020, the Company issued a note payable (the “Note”) for the purchase of a directors’ and officers’ liability insurance policy. The Note is payable in nine monthly payments of $53,750 for an aggregate principal amount of $475,216. The Note accrues interest at a rate of 4.29% per year and matures on November 24, 2020. During the nine months ended September 30, 2020, the Company repaid principal on the Note in the aggregate amount of $368,289.

 


EYENOVIA, INC.

 

NOTES TO CONDENSED FINANCIAL STATEMENTS

 

(UNAUDITED)

Note 6 – Notes Payable – Continued

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”). The PPP Loan provides for monthly installment payments of $19,508 beginning in August 2021 with the remaining balance due on May 3, 2022, the maturity date. The PPP Loan bears interest at a fixed rate of 1.00% per annum.

Under the terms of the CARES Act, as amended by the Paycheck Protection Program Flexibility Act of 2020, the Company is eligible to apply for and receive forgiveness for all or a portion of its PPP Loan. Such forgiveness will be determined, subject to limitations, based on the use of the loan proceeds for certain permissible purposes as set forth in the PPP Loan, including, but not limited to, payroll costs and mortgage interest, rent or utility costs (collectively, “Qualifying Expenses”) incurred during the 24 weeks subsequent to funding, and on the maintenance of employee and compensation levels following the funding of the PPP Loan. The Company intends to use the proceeds of its PPP Loan for Qualifying Expenses. However, no assurance is provided that the Company will be able to obtain forgiveness of its PPP Loan in whole or in part. Any amounts that are not forgiven incur interest at 1.0% per annum and monthly repayments of principal and interest are deferred until six months after the Small Business Administration makes a determination on forgiveness. While the PPP Loan currently has a two-year maturity, the amended law permits the borrower to request a five-year maturity from its lender.

During the three months ended September 30, 2020 and 2019, the Company recorded interest expense of $3,824 and $0, respectively, and $9,855 and $0 for the nine months ended September 30, 2020 and 2019, respectively.

 

Note 67 – Commitments and Contingencies

 

Employment Agreements

Effective February 15, 2019, the CompanySee Note 8 – Related Party Transactions for certain commitments and contingencies entered into at-will executive employment agreements with Tsontcho Ianchulev, its Chief Executive Officer and Chief Medical Officer, John Gandolfo, its Chief Financial Officer, Jennifer Clasby, its Vice President, Clinical Operations, Luke Clauson, its Vice President, Research and Development and Manufacturing, and Michael Rowe, now its Vice President, Commercial.

Each of the employment agreements provides that if the executive’s employment is terminated by the Company without “Cause” or the executive suffers an “Involuntarily 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: (i) severance pay equal to three months of his or her then-current base salary (currently estimated at approximately $419,000 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 three months or until the executive becomes eligible for comparable insurance benefits from another employer, whichever is earlier.

Each of the employment agreements also provides that if within 12 months following any “Corporate Transaction” (as defined in the employment agreements) of the Company, if the executive’s employment is terminated by the Company without Cause or the executive suffers an Involuntary Termination, provided that the executive has signed a full release of all claims, the executive will be entitled to receive, in lieu of what is described in the above paragraph: (i) severance pay equal to 12 months of his or her then-current base salary (currently estimated at approximately $1,677,000 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 12 months or until the executive becomes eligible for comparable insurance benefits from another employer, whichever is earlier.certain related parties.

 

Litigations, Claims and Assessments

 

The Company may be involved in legal proceedings, claims and assessments arising in the ordinary course of business. The Company records legal costs associated with loss contingencies as incurred and accrues for all probable and estimable settlements.

Arctic Vision License Agreement

On August 10, 2020, the Company entered into a License Agreement (the “Arctic Vision License Agreement”) with Arctic Vision (Hong Kong) Limited (“Arctic Vision”) 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.

Under the terms of the Arctic Vision License Agreement, the Company received an upfront payment of $4.0 million, before any payments to Senju Pharmaceutical Co., Ltd. (“Senju”). The Company will record this payment as a deferred license fee in the unaudited condensed balance sheet until the payment is earned. The Company will consider payment earned once certain trial data has been submitted to Arctic Vision, permitting Arctic Vision to obtain regulatory approval with the National Medical Products Administration. In addition, the Company may receive up to a total of $41.75 million in additional payments, based on various development and regulatory milestones, including the initiation of clinical research and approvals in Greater China and South Korea, and development costs. Arctic Vision also will purchase its supply of MicroPine and MicroLine 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. The Company will pay a mid-double digit percentage of such payments, royalties, or net proceeds of such supply to Senju pursuant to its Exclusive License Agreement with Senju, as amended. See Note 8 – Related Party Transactions. During the three and nine months ended September 30, 2020, the Company did not earn any fees related to the Arctic Vision License Agreement.


EYENOVIA, INC.

NOTES TO CONDENSED FINANCIAL STATEMENTS

(UNAUDITED)

 

Note 78 – Related Party Transactions

 

Consulting Agreements

 

A company in which a member of the Company’s Board of Directors is part owner iswas a party to a consulting agreement with the Company, dated July 6, 2017, that provideswhich provided for the payment of $9,567 per month, and $250 per hour for any additional work, for advisory services performed by such director. The consulting agreement was terminated on September 1, 2020. The director remains on the Board. The Company incurred expenses of $49,451$19,134 and $35,018$49,451 for the three months ended September 30, 20192020 and 2018,2019, respectively, and $151,853$57,402 and $127,478$151,853 for the nine months ended September 30, 20192020 and 2018,2019, respectively, related to the agreement which was included within general and administrative expenses on the unaudited condensed statements of operations.

 

Lease Agreements

The Company paid $3,000 and $4,000 per month as of July 2016 and January 2018, respectively, to a company controlled by a member of its Board of Directors for office space in New York, NY for its Chief Executive Officer. The Company left the space on August 31, 2018. During the three months ended September 30, 2019 and 2018, the Company recorded rent expense of $0 and $8,000, respectively, and $0 and $32,000 for the nine months ended September 30, 2019 and 2018, respectively, related to the office space which was included within general and administrative expenses on the condensed statements of operations.


EYENOVIA, INC.

NOTES TO CONDENSED FINANCIAL STATEMENTS

(UNAUDITED)

Note 7 – Related Party Transactions – Continued

Lease Agreements – Continued

 

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. The initial monthly base rent was $3,895 per month over the term of the lease and the security deposit was $3,895. 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. 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. 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. The Company made $40,000$70,000 of leasehold improvements related to this lease which are included on the balance sheet. The Company’s rent expense amounted to $12,036$15,982 and $11,747$12,036 for the three months ended September 30, 20192020 and 2018,2019, respectively, and $36,108$43,512 and $35,117, respectively,$36,108 for the nine months ended September 30, 20192020 and 2018,2019, respectively.

 

Research and Development Activities

 

The VP of R&D is the sole owner and President of a company that performs contract engineering services for the Company. During the three and nine months ended September 30, 2020, the Company recognized research and development expense of $323,187 and $795,992, respectively, related to services provided by such vendor. During the three and nine months ended September 30, 2019, the Company recognized research and development expense of $197,543 and $728,103, respectively, related to services provided by such vendor. DuringThe Company had a liability of $120,584 and $89,052 to the vendor as of September 30, 2020 and December 31, 2019, respectively.

The Company recognized $46,050 and $143,437 of compensation expense related to the VP of R&D’s salary during the three and nine months ended September 30, 2018, the Company recognized research and development expense of $243,614 and $672,057, respectively, related to services provided by such vendor. The Company had a liability of $133,251 and $100,667 to the vendor as of September 30, 2019 and December 31, 2018,2020, respectively.

The Company recognized $46,010 and $140,110 of compensation expense related to the VP of R&D’s salary during the three and nine months ended September 30, 2019, respectively. The Company recognized $46,050 and $128,550 of compensation expense during the three and nine months ended September 30, 2018, respectively.

 

License Agreement

 

DuringOn March 8, 2015, the Company entered into a license agreementan Exclusive License Agreement (the “Exclusive License Agreement”) with Senju Pharmaceuticals Co., Ltd. (“Senju”) whereby the Company agreed to grant to Senju an exclusive, royalty-bearing license, with rights of sublicense, for its microdose product candidatesmedical device technology for Asiathe piezoelectric delivery of ophthalmic medications to sublicense, develop, make, have made, manufacture, use, import, market, sell, and otherwise distribute the microdose product candidates.such products in Asia. In consideration for the license, Senju agreed to pay to Eyenovia five percent (5%)5% royalties on sales (net of certain manufacturing costs) for the term of the license agreement.Exclusive License Agreement, subject to certain adjustments upon the loss of patent coverage. The agreementExclusive License Agreement will continue in full force and effect, on a country-by-country basis, until the latestlater to occur of: (i) the tenth (10th) anniversary of the first commercial sale of such a microdose product candidate in Asia;a country or (ii) the expiration of the licensed patents.patents in a country. As of the date of this filing, there had been no commercial sales of such a microdose product candidate in Asia, such thatand, therefore, no royalties had been earned. 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.


EYENOVIA, INC.

NOTES TO CONDENSED FINANCIAL STATEMENTS

(UNAUDITED)

Note 8 – Related Party Transactions - Continued

License Agreement – Continued

On April 8, 2020, Eyenovia entered into an amendment (the “License Amendment”) to the Exclusive License Agreement. 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 is executed by the Company by April 8, 2021. 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.

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; and (b) a lower-double digit percentage of any sales royalty revenue the Company receives from the third party. Unless a third-party license is executed by the Company prior to April 8, 2021 (in which case, subject to early termination the License Amendment shall remain in effect for the duration of such license), the License Amendment terminates on April 8, 2021, but may be terminated earlier by Senju upon the Company’s material breach of the License Amendment, subject to a 60-day cure period.

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”).  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. During the nine months ended September 30, 2020, the Company paid Senju $1.6 million in connection with the Arctic Vision License Agreement which was recorded as deferred license costs in the Company’s unaudited condensed balance sheet and will be recognized as expense upon earning the related fee. See Note 7 – Commitments and Contingencies for additional details.

 

Note 89 – Stockholders’ Equity

 

Public OfferingEquity Incentive Plan

 

On July 15, 2019,April 7, 2020, the Company closed an underwritten public offeringCompany’s Board of 4,388,490Directors approved the Company’s Amended and Restated 2018 Omnibus Stock Incentive Plan (the “Restated Plan”), which stockholders approved on June 30, 2020. The Restated Plan makes certain changes to the Company’s 2018 Omnibus Stock Incentive Plan, as amended (the “2018 Plan”). For example, the Restated Plan increases the number of shares of its common stock at a public offering price of $2.78 per share. The Company granted the underwriters a 30-day over-allotment option to purchase up to an additional 658,273 shares of the Company’s common stock reserved for issuance under the 2018 Plan to 2,950,000 shares. The Restated Plan requires that all equity awards issued under the Restated Plan vest at least twelve months from the same price, which was exercised in fullapplicable grant date, subject to accelerated vesting, and provides that no dividend or dividend equivalent will be paid on July 16, 2019. Includingany unvested equity award, although dividends with respect to unvested portions of equity may accrue and be paid when, and if, the over-allotmentawards later vest and the shares are actually issued to the Company issuedgrantee. In addition, the Restated Plan sets an annual limit on the grant date fair value of awards to any non-employee director, together with any cash fees paid during the year, of $150,000, subject to certain exceptions for a totalnon-executive chair of 5,046,763 shares in the underwritten public offering, and received gross proceedsBoard. Finally, the Restated Plan makes several administrative changes to the 2018 Plan, including to clarify that awards made under the Restated Plan are intended to be exempt from or comply with Section 409(A) of approximately $14.0 million and net proceedsthe Internal Revenue Code of approximately $13.0 million, after deducting underwriting discounts, commissions and other offering expenses.1986, as amended.

 


EYENOVIA, INC.

 

NOTES TO CONDENSED FINANCIAL STATEMENTS

 

(UNAUDITED)

 

Note 89 – Stockholders’ Equity – Continued

Securities Purchase Agreement

On March 24, 2020, the Company closed on a private placement of approximately $6.0 million of Units. 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”). 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. 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. 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. 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. 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. See “Warrants” below for additional details.

In connection with the private placement, on March 23, 2020, the Company also entered into a Registration Rights Agreement with the investors. 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. The Company timely filed the registration statement on Form S-3 (Registration Statement No. 333-237790), which was declared and has remained effective with the SEC since May 13, 2020.

Warrants

A summary of the Warrant activity during the nine months ended September 30, 2020 is presented below:

        Weighted    
     Weighted  Average    
     Average  Remaining  Aggregate 
  Number of  Exercise  Life  Intrinsic 
  Warrants  Price  In Years  Value 
Outstanding January 1, 2020  -  $-         
Granted  3,344,154   2.33         
Exercised  (1,248,161)  2.19         
Outstanding September 30, 2020  2,095,993  $2.41   4.0  $1,391,817 
                 
Exercisable September 30, 2020  2,095,993  $2.41   4.0  $1,391,817 


EYENOVIA, INC.

NOTES TO CONDENSED FINANCIAL STATEMENTS

(UNAUDITED)

Note 9 – Stockholders’ Equity – Continued

Warrants – Continued

The following table presents information related to Warrants as of September 30, 2020:

Warrants Outstanding Warants Exercisable 
     Weighted    
  Outstanding  Average  Exercisable 
Exercise Number of  Remaining Life  Number of 
Price Warrants  In Years  Warrants 
$2.0580  133,229   0.5   133,229 
$2.2700  144,256   0.5   144,256 
$2.4696  1,602,128   4.5   1,602,128 
$2.7240  216,380   4.5   216,380 
   2,095,993   4.0   2,095,993 

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, respectively, were exercised for aggregate proceeds of approximately $2.3 million. During the nine months ended September 30, 2020, Warrants for the purchase of 1,248,161 shares of the Company’s common stock with exercise prices of either $2.058 or $2.4696 per share, respectively, were exercised for aggregate proceeds of approximately $2.6 million.

Underwritten Public Offering

On August 19, 2020, the Company entered into an Underwriting Agreement (the “Underwriting Agreement”) with several underwriters (the “Underwriters”) in connection with the public offering (the “Offering”) of 3,333,334 shares of the Company’s common stock at a price of $3.60 per share, less underwriting discounts and commissions. In addition, pursuant to the terms of the Underwriting Agreement, the Company granted the Underwriters a 30-day option to purchase up to an additional 500,000 shares of the Company’s common stock at the same price. The Underwriting Agreement contains customary representations, warranties and covenants of the Company and also provides for customary indemnification by the Company and the Underwriters against certain liabilities and customary contribution provisions in respect of those liabilities.

The closing of the Offering occurred on August 21, 2020. At closing, the Company issued 3,833,334 shares of common stock and received net proceeds of approximately $12.5 million after deducting underwriting discounts and commissions and offering expenses of approximately $1.3 million.

The Offering was made pursuant to the Company’s effective registration statement on Form S-3 (Registration Statement No. 333-229365), including the prospectus dated February 12, 2019, as supplemented by the prospectus supplement dated August 19, 2020.

 

Stock Options

 

On January 2, 2019, stock options to purchase 180,000 and 133,686 shares of common stock with an exercise price of $1.24 and $1.95 per share, respectively, were exercised for aggregate proceeds of $483,888.

On January 14, 2019,31, 2020, the Company granted ten-year stock options to purchase an aggregate of 11,00025,000 shares of common stock to its employees under the Company’s 2018 Omnibus Stock Incentive Plan (the “2018 Plan”).Plan. The 11,000 shares vest over three years from the date of grant with one-third vesting on the one-year anniversary of the date of grant and the balance vesting monthly over the remaining 24 months, subject to continued service to the Company.months. The stock options have an exercise price of $2.74$4.68 per share, which represents the Company’s closing stock price on the date of grant. The stock options had a grant date fair value of $27,500,$89,400, which the Company expects to recognize over the vesting period.

 


On February 6, 2019, stock options to purchase an aggregate of 320,001 shares of common stock with an exercise price of $1.24 per share were exercised on a cashless basis, which resulted in the issuance of an aggregate of 236,466 shares of common stock.EYENOVIA, INC.

 

On February 13, 2019, the Board of Directors of the Company approved the acceleration and immediate vesting of 124,210 stock options originally granted to Dr. Ianchulev on July 24, 2018 in connection with his employment. In connection with the acceleration and immediate vesting, the Company recognized $609,322 of stock-based compensation expense during the six months ended June 30, 2019, which represents the remaining unamortized grant date fair value of the award.NOTES TO CONDENSED FINANCIAL STATEMENTS

(UNAUDITED)

Note 9 – Stockholders’ Equity – Continued

Stock Options - Continued

 

On May 14, 2019, stock options to purchase 34,815 shares of common stock with an exercise price of $1.95 per share were exercised for aggregate proceeds of $67,889.

During the three months ended September 30, 2019,28, 2020, the Company granted ten-year stock options to purchase an aggregate of 681,572263,500 shares of common stock to its employees consultants and directors under the 2018 Plan, as amended. Of the 681,572Restated Plan. The shares (i) 636,287 vest over three years from the date of grant with one-third vesting on the one-year anniversary of the date of grant and the balance vesting monthly over the remaining 24 months, subject to continued service to the Company and (ii) 45,285 vest on the earlier of the one-year anniversary of the date of grant and the date of the 2020 annual stockholders meeting, subject to continued service to the Company.months. The stock options have an exercise price of $3.11$2.89 per share, which represents the Company’s closing stock price on the date of grant. The stock options had a grant date fair value of $1,909,700,$587,100, which the Company expects to recognize over the vesting period.

On June 3, 2020, the Company granted ten-year stock options to purchase 764,419 shares of common stock to its executive officers under the Restated Plan. The shares vest over three years from the date of grant with one-third vesting on the one-year anniversary of the date of grant and the balance vesting monthly over the remaining 24 months. The stock options have an exercise price of $2.72 per share, which represents the Company’s closing stock price on the date of grant. The stock options had a grant date fair value of $1,603,600, which the Company expects to recognize over the vesting period.

On July 28, 2020, the Company granted ten-year stock options to purchase 43,000 shares of common stock to an employee under the Restated Plan. The shares vest over three years from the date of grant with one-third vesting on the one-year anniversary of the date of grant and the balance vesting monthly over the remaining 24 months. The stock options have an exercise price of $3.71 per share, which represents the Company’s closing stock price on the date of grant. The stock options had a grant date fair value of $122,400, which the Company expects to recognize over the vesting period.

On September 8, 2020, the Company granted ten-year stock options to purchase 45,000 shares of common stock to employees and consultants under the Restated Plan. The shares vest over three years from the date of grant with one-third vesting on the one-year anniversary of the date of grant and the balance vesting monthly over the remaining 24 months. The stock options have an exercise price of $3.48 per share, which represents the Company’s closing stock price on the date of grant. The stock options had a grant date fair value of $126,700, which the Company expects to recognize over the vesting period.

On September 11, 2020, the Company granted ten-year stock options to purchase 58,920 shares of common stock under the Restated Plan to members of its Board of Directors. The shares vest 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. The stock options have an exercise price of $3.43 per share, which represents the Company’s closing stock price on the date of grant. The stock options had a grant date fair value of $155,400, which the Company expects to recognize over the vesting period.

 

In applying the Black-Scholes option pricing model to stock options granted, the Company used the following approximate assumptions:

 

 For the Three Months Ended For the Nine Months Ended For the Three Months Ended For the Nine Months Ended 
 September 30, September 30, September 30,  September 30, 
 2019 2018 2019 2018 2020  2019  2020  2019 
Expected term (years) 5.85 - 10.00 5.50 - 10.00 5.85 - 10.00 5.50 - 10.00  5.85 - 10.00   5.85 - 10.00   5.85 - 10.00   5.85 - 10.00 
Risk free interest rate 1.42% - 1.55% 2.74% - 2.95% 1.42% - 2.53% 2.69% - 2.95%  0.26% - 0.69%   1.42% - 1.55%   0.26% - 1.32%   1.42% - 2.53% 
Expected volatility 134% 141% 134% - 139% 140 - 141%  98% - 99%   134%   96% - 99%   134% - 139% 
Expected dividends 0.00% 0.00% 0.00% 0.00%  0.00%   0.00%   0.00%   0.00% 

 

The Company has computed the fair value of stock options granted using the Black-Scholes option pricing model. Option forfeitures are accounted for at the time of occurrence. The expected term is the estimated period of time that options granted are expected to be outstanding. The Company utilizes the “simplified” method to develop an estimate of the expected term of “plain vanilla” employee option grants. The Company does not yet have a trading history to support its historical volatility calculations. Accordingly, the Company is utilizing an expectedused a blended volatility figure based on a review of thewhereby it uses its historical volatility for the period from its IPO through the valuation date and uses the average of peer-group data of six comparable entities over a period of time equivalent to supplement its own historical data for the preceding years in computing its expected life of the instrument being valued.volatility. The risk-free interest rate was determined from the implied yields from U.S. Treasury zero-coupon bonds with a remaining term consistent with the expected term of the instrument being valued.

 


EYENOVIA, INC.

NOTES TO CONDENSED FINANCIAL STATEMENTS

(UNAUDITED)

Note 9 – Stockholders’ Equity – Continued

Stock Options – Continued

The weighted average estimated grant date fair value of the stock options granted for the three and nine months ended September 30, 2020 and 2019 was approximately $3.11$2.71 and $3.10$3.11 per share, respectively. The weighted average estimated grant date fair value of the stock options granted for the three and nine months ended September 30, 20182020 and 2019 was approximately $5.66$2.24 and $6.39$3.10 per share, respectively.

A summary of the stock option activity during the nine months ended September 30, 2020 is presented below:

        Weighted    
     Weighted  Average    
     Average  Remaining  Aggregate 
  Number of  Exercise  Life  Intrinsic 
  Options  Price  In Years  Value 
Outstanding January 1, 2020  2,237,438  $3.51         
Granted  1,199,839   2.90         
Exercised  (26,737)  1.95         
Outstanding September 30, 2020  3,410,540  $3.31   8.2  $1,652,315 
                 
Exercisable September 30, 2020  1,698,779  $3.43   7.0  $1,280,864 

The following table presents information related to stock options as of September 30, 2020:

Options Outstanding Options Exercisable 
     Weighted    
  Outstanding  Average  Exercisable 
Exercise Number of  Remaining Life  Number of 
Price Options  In Years  Options 
$1.24  260,000   4.5   260,000 
$1.95  673,544   6.8   673,544 
$2.72  764,419   -   - 
$2.74  6,000   8.3   3,333 
$2.89  263,500   -   - 
$3.11  681,572   8.9   275,064 
$3.43  58,920   -   - 
$3.48  45,000   -   - 
$3.71  43,000   -   - 
$4.00  2,000   8.1   1,223 
$4.68  25,000   -   - 
$5.10  6,000   7.9   4,000 
$5.19  16,500   7.9   11,000 
$5.25  26,668   6.0   26,501 
$6.20  311,499   7.8   265,680 
$6.30  60,000   7.8   43,333 
$8.72  166,918   7.5   135,101 
   3,410,540   7.0   1,698,779 

 


EYENOVIA, INC.

 

NOTES TO CONDENSED FINANCIAL STATEMENTS

 

(UNAUDITED)

 

Note 89 – Stockholders’ Equity – Continued

 

Stock Options – ContinuedOption Exercises

 

A summary ofDuring the option activity during thethree and nine months ended September 30, 2019 is presented below:

        Weighted    
     Weighted  Average    
     Average  Remaining  Aggregate 
  Number of  Exercise  Life  Intrinsic 
  Options  Price  In Years  Value 
Outstanding January 1, 2019  2,220,868  $3.01         
Granted  692,572   3.10         
Exercised  (668,502)  1.42         
Forfeited  (7,500)  4.73         
Outstanding September 30, 2019  2,237,438  $3.51   8.4  $2,273,629 
                 
Exercisable September 30, 2019  1,040,178  $3.34   7.5  $1,407,386 

The following table presents information related to2020, stock options asfor the purchase of September 30, 2019:

Options Outstanding  Options Exercisable 
      Weighted    
   Outstanding  Average  Exercisable 
Exercise  Number of  Remaining Life  Number of 
Price  Options  In Years  Options 
$1.24   260,000   5.5   260,000 
$1.95   700,281   7.8   438,363 
$2.74   6,000   -   - 
$3.11   681,572   -   - 
$4.00   2,000   -   - 
$5.10   6,000   8.9   2,167 
$5.19   16,500   8.9   5,500 
$5.25   26,668   7.0   19,582 
$6.20   311,499   8.8   210,690 
$6.30   60,000   8.8   23,333 
$8.72   166,918   8.5   80,542 
     2,237,438   7.5   1,040,178 

26,737 shares of the Company’s common stock with an exercise price of $1.95 per share was exercised for proceeds of $52,137.

 

Restricted Stock Units

 

On August 16, 2019,September 11, 2020, the Company granted to members of its Board of Directors an aggregate of 40,19043,728 restricted stock units (“RSUs”) under the 2018 Plan, as amended.Restated Plan. Each RSU is subject to settlement into one share of the Company’s common stock. The grantsRSUs vest on the earlier of (i) the one-year anniversary of the date of grant and (ii) the date of the 20202021 annual stockholders meeting, subject to the grantee remaining on the Board until then. The RSUs had a grant date fair value of $125,000,$150,000, which will be recognized over the vesting period.


EYENOVIA, INC.

NOTES TO CONDENSED FINANCIAL STATEMENTS

(UNAUDITED)

Note 8 – Stockholders’ Equity – Continued

 

Stock-Based Compensation Expense

 

The Company recordsrecorded stock-based compensation expense related to stock options and RSUs. During the three months ended September 30, 20192020 and 2018,2019, the Company recorded expense of $609,930 ($346,293 of which was included within research and development expenses and $263,637 of which was included within general and administrative expenses on the condensed statement of operations) and $476,843 ($255,323 of which was included within research and development expenses and $221,520 of which was included within general and administrative expenses on the condensed statementsstatement of operations), respectively. During the nine months ended September 30, 2020 and $462,9452019, the Company recorded expense of $1,826,941 ($240,4321,002,149 of which was included within research and development expenses and $222,513$824,792 was included within general and administrative expenses on the condensed statementsstatement of operations which includes a credit associated with the mark-to-market of non-employee options), respectively. During the nine months ended September 30, 2019operations) and 2018, the Company recorded expense of $1,933,822 ($1,156,241 of which was included within research and development expenses and $777,581 was included within general and administrative expenses on the condensed statements of operations) and $1,115,034 ($556,721 of which was included within research and development expenses and $558,313 was included within general and administrative expenses on the condensed statementsstatement of operations), respectively. As of September 30, 2019,2020, there was $3,827,342$4,145,595 of unrecognized stock-based compensation expense which will be recognizedthe Company expects to recognize over a weighted average period of 2.1 years.

 

Note 910 – Employee Benefit Plans

 

401(k) Plan

 

In April 2019, the Company adopted the Eyenovia 401(k) Plan (the “Plan”), which went into effect in May 2019. All Company employees are able to participate in the Plan, subject to eligibility requirements as outlined in the Plan documents. Under the terms of the Plan, eligible employees are able to defer a percentage of their pay every pay period up to annual limitations set by Congress and the Internal Revenue Service under Section 401(k) of the Internal Revenue Code. For 2019,2020, 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. During the three and nine months ended September 30, 2020 and 2019, the Company recorded expense of $25,535 and $26,989 associated with its matching contributions, respectively. During the nine months ended September 30, 2020 and 2019, the Company recorded expense of $106,021 and $43,032 associated with its matching contributions, respectively.

 

Note 1011 – Subsequent Events

 

Bausch License Agreement

On October 29, 2019,9, 2020, the Company announced that it is advancing its MicroLine programforentered into the improvementBausch License Agreement pursuant to which Bausch Health may develop and commercialize the Company’s MicroPine therapeutic candidate (the “Bausch Licensed Product”) in near vision in patients with presbyopia towards Phase III development. As a result of prioritizing MicroLine, in tandem with its MicroPine (progressive myopia)the United States and MicroStat (mydriasis) programs, the Company has deferred development activities for its MicroProst (glaucoma and ocular hypertension) and MicroTears (red eye and itch relief lubrication) programs. The Company believes the reprioritization of its programs will yield overall cost savings of approximately $1.5 million to $1.9 million in 2020.Canada (the “Licensed Territory”).

 


EYENOVIA, INC.

NOTES TO CONDENSED FINANCIAL STATEMENTS

(UNAUDITED)

Note 11 – Subsequent Events – Continued

Bausch Health License Agreement - Continued

In connection with the Bausch License Agreement, Bausch Health paid the Company an upfront payment of $10.0 million. Bausch Health might 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. Under the terms of the Bausch License Agreement, on a country-to-country basis and Bausch Licensed Product-by- Bausch Licensed Product basis, Bausch Health will pay the Company a 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 United States and Canada, 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. Under the terms of the Bausch License Agreement, Bausch Health also has assumed oversight and costs related to the ongoing MicroPine study (the CHAPERONE study).

Bausch Health may 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. Both parties have the right to terminate the Bausch License Agreement in the event of (i) an uncured material breach after a 60-day period or (ii) a bankruptcy event.


Item 2. Management’s Discussion and Analysis of Financial Condition and Results of Operations.

 

The following discussion and analysis of the results of operations and financial condition of Eyenovia, Inc. (“Eyenovia,” the “Company,” “we,” “us” and “our”) as of September 30, 20192020 and for the three and nine months ended September 30, 20192020 and 20182019 should be read in conjunction with our unaudited condensed financial statements and the notes thereto included elsewhere in this Quarterly Report on Form 10-Q and with our audited financial statements and the notes thereto included in our Annual Report on Form 10-K for the year ended December 31, 20182019 as filed with the Securities and Exchange Commission (“SEC”) on March 27, 2019.30, 2020.

 

Forward Looking Statements

 

This report contains “forward-looking statements.” Specifically, all statements other than statements of historical facts included in this report, including regarding our financial position, business strategy and plans and objectives of management for future operations, are forward-looking statements. These forward-looking statements are based on the beliefs of management at the time these statements were made, as well as assumptions made by and information currently available to management. When used in this report, the words “anticipate,” “believe,” “estimate,” “expect,” “may,” “might,” “will,” “continue” “intend,” and “plan” and words or phrases of similar import are intended to identify forward-looking statements. These statements reflect our current view with respect to future events and are subject to risks, uncertainties and assumptions related to various factors that could cause actual results and the timing of events to differ materially from future results expressed or implied by such forward-looking statements. Factors that could cause or contribute to such differences include, but are not limited to, those discussed in the section titled “Risk Factors” included in our most recent Annual report on Form 10-K filed with the SEC. Furthermore, such forward-looking statements speak only as of this Quarterly Report on Form 10-Q. Except as required by law, we undertake no obligation to update any forward-looking statements to reflect events or circumstances after the date of such statements.

 

Overview

 

We are a clinical stage ophthalmic biopharmaceutical company developing a pipeline of microdose therapeutics utilizing our patented piezo-print delivery technology, branded the OptejetTM. Eyenovia aimsarray print (MAP™) therapeutics. We aim to achieve clinical microdosing of next-generation formulations of well-established ophthalmic pharmaceutical agents using itsour 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. In the clinic, the Optejet has demonstrated the ability to horizontally deliver ophthalmic medication with a success rate significantly higher than traditional eye drops (~ 90% vs. ~ 50%). Our technology also can deliver up to a 75% reduction in ocular drug and preservative exposure with successful topical delivery that is consistent withand has demonstrated significant improvement in the efficacy of traditional eye drop administration.therapeutic index in drugs used for mydriasis and IOP lowering through three Phase II and Phase III trials. Using its proprietary delivery technology, Eyenovia isthe Optejet, we are developing the next generation of smart ophthalmic therapies while targetingtherapeutics which target new indications for whichor new combinations where there are currently no comparable drug therapies approved by the United StatesU.S. Food and Drug Administration, or the FDA. Eyenovia’sOur microdose therapeutics follow the FDA-designated pharmaceutical registrationalregistration and regulatory process. ItsOur products are not classified by the FDA as drugs, and not medical devices or drug-device combination products. Our pipeline is currently focused on the late-stage development of microdosed medications for progressive myopia, presbyopia, and mydriasis.

 

MicroPine is our first-in-class topical therapy for the treatment of progressive myopia, a back-of-the-eye ocular disease associated with pathologic axial elongation and sclero-retinal stretching. In the United States, myopia is estimated to affect approximately 25 million children, with up to 3 million considered to be at risk for high myopia. In February 2019, the FDA accepted our investigational new drug application, or IND, to initiate a Phase III registration trial of MicroPine (the CHAPERONE study) to reduce the progression of myopia in children. We enrolled the first patient in the CHAPERONE study in June 2019. Due to the COVID-19 pandemic, we previously experienced delays in trial enrollment and initiation as a result of reduced clinical trial activities and operations at investigator sites. However, we have since been able to resume enrollment in the CHAPERONE study.

On October 29, 2019,9, 2020, we entered into a License Agreement (the “Bausch License Agreement”) with a subsidiary of Bausch Health Companies Inc. (“Bausch Health”), pursuant to which Bausch Health may develop and commercialize MicroPine in the Company announced that itUnited States and Canada . Under the terms of the Bausch License Agreement, we received an upfront payment of $10.0 million and we may receive up to a total of $35.0 million in additional payments, based on the achievement of certain regulatory and launch-based milestones. Bausch Health also will pay us royalties on a tiered basis (ranging from mid-single digit to mid-teen percentages) on gross profits from sales of MicroPine in the United States and Canada, subject to certain adjustments. Under the terms of the Bausch License Agreement, Bausch Health has assumed oversight and costs related to the ongoing CHAPERONE study.


MicroLine is advancing the development of its MicroLine programour pharmacologic treatment for the improvement in near vision in patients with presbyopia towards Phase III development. As a result of prioritizing MicroLine, in tandem with its MicroPine (progressive myopia) and MicroStat (mydriasis) programs, the Company has deferred development activities for its MicroProst (glaucoma and ocular hypertension) and MicroTears (red eye and itch relief lubrication) programs.

presbyopia. Presbyopia is a non-preventable, age-related hardening of the lens, which causes the gradual loss of the eye’s ability to focus on nearby objects, commonly known as farsightedness.objects. There currently are currently no known FDA-approved drugs for the improvement of near vision in patients with presbyopia. Eyenovia plans to initiate and complete itspresbyopia, although other companies have related therapies in their pipeline. We have two planned Phase III VISION trials for MicroLine, in 2020.MicroPine isand subject to any impacts of the Company’s first-in-class topical therapy for the treatment of progressive myopia, a back-of-the-eye ocular disease associated with pathologic axial elongation and sclero-retinal stretching affecting approximately five million people in the United States. In February 2019, the FDA accepted Eyenovia’s investigational new drug application, or IND, to initiate itsCOVID-19 pandemic, we anticipate initiating our Phase III registration trialVISION trials in 2020.

On August 10, 2020, we entered into a License Agreement (the “Arctic Vision License Agreement”) with Arctic Vision (Hong Kong) Limited (“Arctic Vision”), pursuant to which Arctic Vision may develop and commercialize MicroPine and MicroLine in Greater China (mainland China, Hong Kong, Macau and Taiwan) and South Korea. Under the terms of the Arctic Vision License Agreement, we received an upfront payment of $4.0 million before any payments to Senju Pharmaceutical Co., Ltd. (“Senju”). In addition, we may receive up to a total of $41.75 million in additional payments, based on various development and regulatory milestones, including the initiation of clinical research and approvals in Greater China and South Korea, and development costs. Arctic Vision also will purchase its supply of MicroPine (the CHAPERONE study)and MicroLine from us or, for such products not supplied by us, pay us a mid-single digit percentage royalty on net sales of such products, subject to reducecertain adjustments. We will pay a mid-double digit percentage of such payments, royalties, or net proceeds of such supply to Senju pursuant to the progression of myopia in children. We enrolledExclusive License Agreement with Senju dated March 8, 2015, as amended by the License Amendment dated April 8, 2020, and a Letter Agreement dated August 10, 2020.

MicroStat (or Mydcombi™) is our first patient in the CHAPERONE study in June 2019 and expect to complete enrollment in 2020. Eyenovia has completed its Phase III trials for MicroStat and announced positive results from these studies, known as MIST-1 and MIST-2. MicroStat is a fixed combination formulation of phenylephrine-tropicamide for mydriasis, designed to be a novel approach for the estimated 80 million office-based comprehensive and diabetic eye exams performed every year in the United States. With the primary objectives of itsWe have completed two Phase III programtrials for MicroStat met, Eyenovia plansand announced positive results from these studies, known as MIST-1 and MIST-2. We currently remain on track to submitfile a new drug application, or NDA, towith the FDA for MicroStat in 2020 for marketing approval in the United States.


Results from our previous three Phase II clinical trials have been published in peer-reviewed literature. Two studies evaluating our mydriatic agents demonstrated how the Optejet consistently delivered precision dosing at the volume of the eye’s natural tear film capacity of 6-8 µL, which reduced ocular and systemic drug and preservative exposure, while demonstrating pupil dilation comparable to conventional eye drops with fewer side effects. In the third study, we evaluated usability, patient tolerability and IOP lowering of microdosed latanoprost administered with the Optejet. In this study, eyes receiving microdosed latanoprost achieved IOP reduction consistent with published literature on latanoprost eye drops, and administration of the medication was successful in a single attempt in more than 90% of cases. Based on the results from these clinical trials, we are able to advance MicroLine, MicroPine, MicroStat, and MicroProst (should we resume the program) into Phase III utilizing the 505(b)(2) pathway and plan to do the same with MicroPine, MicroLine and MicroProst. Where possible, we also intend to use this pathway for future clinical trials in new indications with significant unmet needs.2020.

 

We have not completed development of any product candidate and we have therefore not generated any revenues from product sales.

 

Historically, we have financed our operations principally through stockequity offerings, including our initial public offering, numerous public offerings in 2018, 2019 and follow-on public offeringAugust 2020, and our private placement that closed in January and December 2018, respectively and our public offering that closed in July 2019. Although it is difficult to predict our liquidity requirements, basedMarch 2020. Recently we also have generated cash through licensing arrangements. Based upon our current operating plan, we believe we will have sufficient cash to meet our projected operating requirements for at least the next twelve months.months from the date of filing. Thereafter, the Company willwe may need to raise further capital, through the sale of additional equity or debt securities, to support itsour future operations. If the Company iswe are unable to secure additional capital, itwe may be required to curtail itsour research and development initiatives and take additional measures to reduce costs.

 

Our net losses were $4.6$5.1 million and $15.9$15.6 million for the three and nine months ended September 30, 2019, respectively.2020. As of September 30, 2019,2020, we had working capital and an accumulated deficit of $16.3$18.6 million and $52.4$73.2 million, respectively.

 

Financial Overview

 

Revenue

 

We have not generated any revenue from product sales since our inception and do not expect to generate any revenue from the sale of products in the near future. Our ability to generate revenues will depend heavily on the successful development, regulatory approval and commercialization of our micro-therapeutic product candidates.

 

Recently, we have licensed the use of our products in certain regions and expect to begin to earn fees from upfront payments and additional payments based on various development and regulatory milestones.

Research and Development Expenses

 

Research and development expenses are incurred in connection with the research and development of our micro-therapeuticsmicrodose-therapeutics and consist primarily of contract service expenses. Given where we are in our life cycle, we do not separately track research and development expenses by project. Our research and development expenses consist of:


 ·direct clinical and non-clinical expenses, which include expenses incurred under agreements with contract research organizations, contract manufacturing organizations, and costs associated with preclinical activities, development activities and regulatory activities;

 

 ·personnel-related expenses, which include expenses related to consulting agreements with individuals that have since entered into employment agreements with us as well as salaries and other compensation of employees that is attributable to research and development activities; and

 

 ·facilities and other expenses, which include direct and allocated expenses for rent and maintenance of facilities, marketing, insurance and other supplies used in research and development activities.

 

We expense research and development costs as incurred. We record costs for some development activities, such as clinical trials, based on an evaluation of the progress to completion of specific tasks using data such as subject enrollment, clinical site activations or other information our vendors provide to us.

 

We expect that our research and development expenses will increase with the continuation of the aforementioned initiatives.

 


General and Administrative Expenses

 

General and administrative expenses consistfor the nine months ended September 30, 2020 totaled $5.7 million, an increase of $0.5 million, or 8%, as compared to $5.2 million recorded for the nine months ended September 30, 2019. This increase was primarily of payroll andattributable to a $0.4 million increase in professional services related to business development activities, a $0.3 million in patent related expenses legalwhich is expected to continue to increase as programs are further developed and other professional services, as well as non-cash stock-based compensation expense. We anticipate that our general and administrative expenses willa $0.1 million increase in liability insurance related to an increase in the future as we increase our headcount to support our continued researchinsurance premium on directors and developmentofficers insurance. This was offset by a $0.3 million decrease in travel and the potential commercialization of our product candidates. We also anticipate increasedentertainment expenses related to audit, legal, regulatory, and tax-related services associated with maintaining compliance with exchange listing and SEC requirements. In addition, director and officer insurance premiums and investor relations costs associated with being a public company are expected to increase in future periods.the impact of the COVID-19 pandemic.

 

Results of Operations

 

Three Months Ended September 30, 20192020 Compared with Three Months Ended September 30, 20182019

 

Research and Development Expenses

 

Research and development expenses for the three months ended September 30, 20192020 totaled $3.2$3.4 million, an increase of $0.7$0.2 million, or 29%5%, as compared to $2.5$3.2 million recorded for the three months ended, September 30, 2018.2019. Research and development expenses consisted of the following:

 

 For the Three Months Ended  For the Three Months Ended 
 September 30,  September 30, 
 2019  2018  2020  2019 
Direct clinical and non-clinical expenses $1,649,929  $1,239,753  $1,745,880  $1,649,931 
Personnel-related expenses  729,011   675,259   890,771   729,010 
Non-cash stock-based compensation expenses  346,294   255,323 
Supplies and materials  325,517   563,544 
Facilities and other expenses  566,933   332,129   55,297   3,388 
Non-cash stock-based compensation expenses  255,323   240,432 
Total research and development expenses $3,201,196  $2,487,573  $3,363,759  $3,201,196 
        

 

The increase in direct clinical and non-clinical expenses and personnel-related expenses iswas primarily due to anincreased activities related to the MicroPine and MicroLine studies in the third quarter of 2020. The increase in contracted services andpersonnel-related expenses was primarily due to the hiring of threesix additional employees as we expanded our research and development activities for our micro-therapeutic products.in the second half of 2019. The increase in facilities and other expenses was primarily due to anincreased depreciation on newly acquired assets. The increase in research and development relatednon-cash stock-based compensation expense was due to additional stock options that were granted subsequent to September 30, 2019. This was slightly offset by a decrease in supplies and materials.materials due to a decrease in spending on device inventory used in clinical trials as the such trials were delayed in the first part of 2020 due to the COVID-19 pandemic.


General and Administrative Expenses

 

General and administrative expenseexpenses for the three months ended September 30, 20192020 totaled $1.5$1.7 million, a decreasean increase of $0.3$0.2 million, or 19%16%, as compared to $1.8$1.5 million recorded for the three months ended September 30, 2018.2019. This decreaseincrease was primarily attributable to a decrease$0.15 million increase in legal and professional fees of $0.4 million due to higher expenses in 2018services related to business development activities performedand $0.1 million increase in patent expense and advertising and marketing as the Company increases activities to asses various financing opportunities.prepare for commercialization. This was slightly offset by an increasea decrease of $0.05 million in payrolltravel expenses related to the impact of $0.1 million from the hiring of an additional four employees.COVID-19 pandemic.

 

Nine Months Ended September 30, 20192020 Compared with Nine Months Ended September 30, 20182019

 

Research and Development Expenses

 

Research and development expenses for the nine months ended September 30, 20192020 totaled $10.8$9.9 million, an increasea decrease of $3.8$0.9 million, or 54%8%, as compared to $7.0$10.8 million recorded for the nine months ended September 30, 2018.2019. Research and development expenses consisted of the following:

 

 For the Nine Months Ended  For the Nine Months Ended 
 September 30,  September 30, 
 2019  2018  2020  2019 
Direct clinical and non-clinical expenses $6,059,900  $3,429,097  $5,076,662  $6,059,900 
Personnel-related expenses  2,253,951   1,726,250   2,533,439   2,253,951 
Non-cash stock-based compensation expenses  1,002,150   1,156,241 
Supplies and materials  1,108,021   1,295,806 
Facilities and other expenses  1,308,022   1,281,763   193,024   12,216 
Non-cash stock-based compensation expenses  1,156,241   556,722 
Total research and development expenses $10,778,114  $6,993,832  $9,913,296  $10,778,114 

 


The increasedecrease in direct clinical and non-clinical expenses and personnel-related expenses issupplies and materials was primarily due to ana decrease in activities related to the impact of the COVID–19 pandemic during the first part of 2020. The increase in contracted servicespersonnel-related expenses and facilities and other expenses was primarily due to the hiring of threesix additional employees as we expanded our research and development activities for our micro-therapeutic products.microdose therapeutics in the second half of 2019. The increasedecrease in non-cash stock-based compensation expense as compared to the 20182019 period was primarily due to certain stock options that were accelerated and immediately vested in February 2019 as well as dueslightly offset by additional options granted subsequent to additional stock option grants inSeptember 30, 2019.

 

General and Administrative Expenses

 

General and administrative expenseexpenses for the nine months ended September 30, 20192020 totaled $5.2$5.7 million, an increase of $1.1$0.5 million, or 28%8%, as compared to $4.1$5.2 million recorded for the nine months ended September 30, 2018.2019. This increase was primarily attributable to ana $0.4 million increase in payroll related expenses of $0.5 million due to the hiring of an additional four employees, $0.4 million in costsprofessional services related to being a public company,business development activities and $0.3 million in advertising and marketingpatent related expenses relatedwhich is expected to marketing analysis upon potential commercialization, $0.2 million of non-cash stock-based compensation, and $0.1 million in rent expense relatedcontinue to the addition of our new leased office space in New York, NY in August 2018.increase as programs are further developed. This was slightly offset by approximatelya $0.3 million decrease in professional fees due to highertravel and entertainment expenses in 2018 related to the initial public offering and activities performed to assess various financing opportunities.impact of the COVID-19 pandemic.

 

Liquidity and Capital Resources

 

Since inception, we have experienced negative cash flows from operations. AtAs of September 30, 2019,2020, our accumulated deficit since inception was $52.4$73.2 million.

 

AtAs of September 30, 2019, we had working capital of $16.3 million and stockholders’ equity of $16.4 million. At September 30, 2019 and December 31, 2018, we had no debt outstanding.

At September 30, 2019,2020, we had a cash balance of $22.9 million, working capital of $18.6 million and stockholders’ equity of $18.7 million. As of September 30, 2020 and December 31, 2019, we had $0.6 million and $0, respectively, of debt outstanding.


In August 2020, we entered into the Arctic Vision License Agreement, pursuant to which we received an upfront payment from Arctic Vision of $4.0 million before any payments to Senju. In addition, during the nine months ended September 30, 2020, we received approximately $18.3 million of net proceeds from our public and private offerings, approximately $2.6 million from the exercise of warrants, and approximately $0.5 million pursuant to a loan provided in connection with the Paycheck Protection Program under the CARES Act. Subsequent to September 30, 2020, we entered into the Bausch License Agreement, pursuant to which we received an upfront payment from Bausch Health of $10.0 million.

We expect our current cash on hand to be sufficient to meet our operating and capital requirements for at least the next twelve months from the date of this filing. Thereafter, we will likelymay need to raise further capital, through the sale of additional equity or debt securities, to support our future operations. Our operating needs include the planned costs to operate our business, including amounts required to fund research and development activities including clinical studies, working capital and capital expenditures. Our future capital requirements and the adequacy of our available funds will depend on many factors, including our ability to successfully manufacture our products and commercialize our 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 our product and service offerings. If we arethe Company is unable to secure additional capital, weit may be required to curtail ourits research and development initiatives and take additional measures to reduce costs in order to conserve our cash.costs.

 

During the nine months ended September 30, 20192020 and 2018,2019, our sources and uses of cash were as follows:

 

Net cash used in operating activities for the nine months ended September 30, 2020 was $11.9 million, which includes cash used to fund a net loss of $15.6 million, reduced by $1.9 million of non-cash expenses, plus $1.8 million of cash generated from changes in operating assets and liabilities. Net cash used in operating activities for the nine months ended September 30, 2019 was $14.9 million, which includes cash used to fund a net loss of $15.9 million, reduced by $1.9 million of non-cash expenses, plus $0.9 million of cash used to fund changes in operating assets and liabilities. Net cash

Cash used in operatinginvesting activities for the nine months ended September 30, 20182020 was $9.0$0.2 million, which includes cash usedwas related to fund a net losspurchases of $11.1 million, reduced by $1.1 million of non-cash stock-based compensation,property and partially offset by $0.9 million of cash provided by changes in operating assets and liabilities.

Net cashequipment. Cash used in investing activities for the nine months ended September 30, 2019 was less than $0.1 million, which was related to purchases of property and equipment. There was no

Net cash used in investingprovided by financing activities for the nine months ended September 30, 2018.

2020 totaled $20.8 million, which was primarily attributable to aggregate net proceeds from the sale of our common stock and warrants in our public offerings of $18.0 million, $2.6 million of proceeds from the exercise of stock warrants, and $0.5 million in proceeds from a loan in connection with the Paycheck Protection Program under the CARES Act. This was slightly offset by the repayment of notes payable of $0.4 million. Cash provided by financing activities for the nine months ended September 30, 2019 totaled $13.5 million, which was attributable to $13.0 million of aggregate net proceeds from the sale of our common stock in oura public offering in July 2019 and $0.5 million of proceeds from the exercise of stock options. Cash provided by financing activities for the nine months ended September 30, 2018 totaled $24.8 million, which was primarily attributable to $25.1 million of proceeds from the sale of common stock in our initial public offering, reduced by issuance costs related to our initial public offering of $0.3 million.

 

Off-Balance Sheet Arrangements

 

There are no off-balance sheet arrangements between us and any other entity that have, or are reasonably likely to have, a current or future effect on financial conditions, changes in financial conditions, revenues or expenses, results of operations, liquidity, capital expenditures or capital resources that is material to stockholders.

 


Critical Accounting Policies

 

For a description of our critical accounting policies, see Note 2 – Summary of Significant Accounting Policies in Part 1, Item 1 of this Quarterly Report on Form 10-Q.

 

Recently Adopted Accounting Pronouncements

 

For a description of recently adopted accounting pronouncements, including adoption dates and estimated effects, if any, on our consolidatedcondensed financial statements, see Note 2 – Summary of Significant Accounting Policies in Part 1, Item 1 of this Quarterly Report on Form 10-Q. 

 

Item 3. Quantitative and Qualitative Disclosures About Market Risk.

 

Smaller reporting companies such as us are not required to provide the information required by this item.

 

Item 4. Controls and Procedures.

 

Evaluation of Disclosure Controls and Procedures

 

As of the end of the period covered by this Quarterly Report on Form 10-Q, we carried out an evaluation, under the supervision and with the participation of our management, including our principal executive officer and principal financial and accounting officer, of the effectiveness of the design and operation of our disclosure controls and procedures as defined in Rules 13a-15(e) and 15d-15(e) of the Securities Exchange Act of 1934, as amended (the “Exchange Act”).

 


In designing and evaluating our disclosure controls and procedures, management recognizes that any disclosure controls and procedures, no matter how well designed and operated, can provide only reasonable assurance of achieving the desired control objectives. In addition, the design of disclosure controls and procedures must reflect the fact that there are resource constraints and that management is required to apply its judgment in evaluating the benefits of possible controls and procedures relative to their costs.

 

Based on their evaluation, our principal executive officer and principal financial and accounting officer concluded that as of September 30, 20192020 our disclosure controls and procedures were designed to, and were effective to, provide assurance at a reasonable level that the information we are required to disclose in reports that we file or submit under the Exchange Act is recorded, processed, summarized and reported within the time periods specified in SEC rules and forms, and that such information is accumulated and communicated to our management, including our principal executive officer and principal financial and accounting officer, as appropriate, to allow timely decisions regarding required disclosures as of September 30, 2019.2020.

 

Changes in Internal Control over Financial Reporting

 

There has been no change in our internal control over financial reporting that occurred during the third quarter of 20192020 that has materially affected, or is reasonably likely to materially affect, our internal control over financial reporting.

 


PART II - OTHER INFORMATION

 

Item 1. Legal Proceedings.

 

None.

 

Item 1A. Risk Factors.

 

Smaller reporting companies such as us are not required to provide the information required by this item.

 

Item 2. Unregistered Sales of Equity Securities and Use of Proceeds.

 

Recent Sales of Unregistered Securities

 

None.

 

Use of Proceeds from Registered Securities Offering

On January 24, 2018, the SEC declared effective our Registration Statement on Form S-1 (File No. 333-222162), as amended, filed in connection with the initial public offering of our common stock. Pursuant to the Registration Statement, we registered the offer and sale of up to $35,000,000 of our common stock. On January 29, 2018, we issued and sold 2,730,000 shares of our common stock at a price to the public of $10.00 per share. Ladenburg Thalmann & Co. Inc., a subsidiary of Ladenburg Thalmann Financial Services Inc., and Roth Capital Partners acted as joint book-running managers for the offering.

As a result of the offering, we received net proceeds of approximately $24.5 million in the aggregate, which consists of gross proceeds of $27.3 million, offset by underwriting discounts and commissions of approximately $1.9 million and other offering expenses of approximately $0.9 million. No payments for such expenses were made directly or indirectly to (i) any of our officers or directors or their associates, (ii) any persons owning 10% or more of any class of our equity securities or (iii) any of our affiliates. The offering has closed.

As of September 30, 2019, all net proceeds from our initial public offering have been deployed in the manner described in our final prospectus, dated January 24, 2018, filed with the SEC pursuant to Rule 424(b) relating to our Registration Statement on Form S-1.

Purchases of Equity Securities by the Issuer and Affiliated Purchasers

 

None.

 

Item 3. Defaults upon Senior Securities.

 

Not applicable.

 

Item 4. Mine Safety Disclosures.

 

Not applicable.

 

Item 5. Other Information.

 

None.

 

19


Item 6. Exhibits.

 

Exhibit   Incorporated by Reference (Unless Otherwise Indicated)
Number Exhibit Description Form File No. Exhibit Filing Date
           
10.20 Eyenovia, Inc. 2014 Equity Incentive Plan, as amended S-8 333-233278 10.14 August 14, 2019
           
10.21 Form of Nonqualified Stock Option Agreement under Eyenovia, Inc. 2014 Equity Incentive Plan, as amended S-8 333-233278 10.15 August 14, 2019
           
31.1 Certification of the Principal Executive Officer pursuant to Section 302 of the Sarbanes-Oxley Act of 2002    Filed herewith
           
31.2 Certification of the Principal Financial and Accounting Officer pursuant to Section 302 of the Sarbanes-Oxley Act of 2002    Filed herewith
           
32.1 Certification of the Principal Executive Officer pursuant to Section 906 of the Sarbanes-Oxley Act of 2002    Filed herewith
           
32.2 Certification of the Principal Financial and Accounting Officer pursuant to Section 906 of the Sarbanes-Oxley Act of 2002    Filed herewith
           
101 Interactive data files pursuant to Rule 405 of Regulation S-T: (i) Balance Sheets as of September 30, 2019 and December 31, 2018; (ii) Statements of Operations for the Nine Months Ended September 30, 2019 and 2018; (iii) Statements of Cash Flows for the Nine Months Ended September 30, 2019 and 2018; and (iv) Notes to Financial Statements    Filed herewith
ExhibitIncorporated by Reference (Unless Otherwise Indicated)
NumberExhibit DescriptionFormFile No.ExhibitFiling Date
10.26#Eyenovia, Inc. Amended and Restated 2018 Omnibus Stock Incentive Plan8-K001-3836510.25July 2, 2020
10.27*Letter Agreement by and between Eyenovia, Inc. and Senju Pharmaceutical Co., Ltd., dated August 10, 202010-Q001-3836510.27August 14, 2020
10.28*License Agreement by and between Eyenovia, Inc. and Artic Vision (Hong Kong) Limited, dated August 10, 202010-Q001-3836510.28August 14, 2020
31.1Certification of the Principal Executive Officer pursuant to Section 302 of the Sarbanes-Oxley Act of 2002Filed herewith
31.2Certification of the Principal Financial and Accounting Officer pursuant to Section 302 of the Sarbanes-Oxley Act of 2002Filed herewith
32.1Certification of the Principal Executive Officer pursuant to Section 906 of the Sarbanes-Oxley Act of 2002Filed herewith
32.2Certification of the Principal Financial and Accounting Officer pursuant to Section 906 of the Sarbanes-Oxley Act of 2002Filed herewith
101Interactive data files pursuant to Rule 405 of Regulation S-T: (i) Condensed Balance Sheets as of September 30, 2020 and December 31, 2019; (ii) Condensed Statements of Operations for the Three and Nine Months Ended September 30, 2020 and 2019; (iii) Condensed Statements of Changes in Stockholders’ Equity for the Three and Nine Months Ended September 30, 2020 and 2019; Condensed Statements of Cash Flows for the Nine Months Ended September 30, 2020 and 2019; and (iv) Notes to Condensed Financial Statements

 


* Portions of this exhibit have been redacted in compliance with Regulation S-K Item 601(b)(10).

# Management contract or other compensatory plan.

26

SIGNATURES

 

Pursuant to the requirements of the Securities Exchange Act of 1934, the Registrant has duly caused this report to be signed on its behalf by the undersigned thereunto duly authorized.

 

 EYENOVIA, INC.
  
November 13, 201912, 2020By:/s/ John Gandolfo
  John Gandolfo
  

Chief Financial Officer

(Principal (Principal Financial and Accounting Officer)