0001104659-23-089813.txt : 20230810 0001104659-23-089813.hdr.sgml : 20230810 20230810161859 ACCESSION NUMBER: 0001104659-23-089813 CONFORMED SUBMISSION TYPE: 8-K PUBLIC DOCUMENT COUNT: 14 CONFORMED PERIOD OF REPORT: 20230810 ITEM INFORMATION: Results of Operations and Financial Condition ITEM INFORMATION: Financial Statements and Exhibits FILED AS OF DATE: 20230810 DATE AS OF CHANGE: 20230810 FILER: COMPANY DATA: COMPANY CONFORMED NAME: EYENOVIA, INC. CENTRAL INDEX KEY: 0001682639 STANDARD INDUSTRIAL CLASSIFICATION: PHARMACEUTICAL PREPARATIONS [2834] IRS NUMBER: 471178401 STATE OF INCORPORATION: DE FISCAL YEAR END: 1231 FILING VALUES: FORM TYPE: 8-K SEC ACT: 1934 Act SEC FILE NUMBER: 001-38365 FILM NUMBER: 231159776 BUSINESS ADDRESS: STREET 1: 295 MADISON AVENUE, STREET 2: SUITE 2400 CITY: NEW YORK STATE: NY ZIP: 10017 BUSINESS PHONE: 813-766-9539 MAIL ADDRESS: STREET 1: 295 MADISON AVENUE, STREET 2: SUITE 2400 CITY: NEW YORK STATE: NY ZIP: 10017 8-K 1 tm2323259d1_8k.htm FORM 8-K
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UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

Washington, D.C. 20549

 

 

FORM 8-K

 

 

CURRENT REPORT

Pursuant to Section 13 or 15(d)

of the Securities Exchange Act of 1934

 

Date of Report (Date of earliest event reported): August 10, 2023

 

 

EYENOVIA, INC.

(Exact Name of Registrant as Specified in its Charter)

 

 

Delaware   001-38365   47-1178401
(State or other jurisdiction
of incorporation)  		   (Commission
 File Number) 		  (IRS Employer
 Identification No.)  

 

295 Madison Avenue, Suite 2400, New York, NY 10017

(Address of Principal Executive Offices, and Zip Code)

 

(833) 393-6684

Registrant’s Telephone Number, Including Area Code 

 

 

Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions:

 

¨ Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)

¨ Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)

¨ Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))

¨ Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))

 

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

 

(Title of each class)   (Trading
Symbol) 		  (Name of each exchange
on which registered)
Common stock, par value $0.0001 per share   EYEN   The Nasdaq Stock Market
 (Nasdaq Capital Market)  

 

Indicate by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (17 CFR §230.405) or Rule 12b-2 of the Securities Exchange Act of 1934 (17 CFR §240.12b-2).

 

Emerging growth company x

 

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 new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. ¨

 

 

 

 

 

 

  Item 2.02. Results of Operations and Financial Condition.

 

On August 10, 2023, Eyenovia, Inc. (the “Company”) issued a press release announcing its financial results for the fiscal quarter ended June 30, 2023. A copy of the press release is furnished as Exhibit 99.1 to this Current Report on Form 8-K and is incorporated herein by reference.

 

The information contained in this Item 2.02, including Exhibit 99.1, is being “furnished” and shall not be deemed “filed” for purposes of Section 18 of the Securities Exchange Act of 1934, as amended (the “Exchange Act”), or otherwise subject to the liability of that Section or Sections 11 and 12(a)(2) of the Securities Act of 1933, as amended (the “Securities Act”). The information contained in this Item 2.02, including Exhibit 99.1, shall not be incorporated by reference into any registration statement or other document pursuant to the Securities Act or into any filing or other document pursuant to the Exchange Act, except as otherwise expressly stated in any such filing.

 

  Item 9.01. Financial Statements and Exhibits.

 

 

(d)           Exhibits  
     
  Exhibit No. Description
     
  99.1 Eyenovia, Inc. Press Release, dated August 10, 2023.
     
  104 Cover Page Interactive Data File (embedded within the Inline XBRL document).

 

 

 

 

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 hereunto duly authorized.

 

  EYENOVIA, INC.
   
Date: August 10, 2023 /s/ John Gandolfo
  John Gandolfo
  Chief Financial Officer

 

 

 EX-99.1 2 tm2323259d1_ex99-1.htm EXHIBIT 99.1

Exhibit 99.1

 

 

 

Eyenovia Reports Second Quarter 2023 Financial Results and Provides Business Update

 

Announced FDA approval of and first commercial sale of Mydcombi™, the only fixed dose combination of tropicamide and phenylephrine for mydriasis and the first FDA approved product to utilize the Optejet®

 

Continued to advance its Phase 3 Apersure™ (Microline) presbyopia candidate following receipt of guidance from FDA that establishes an efficient path forward for the program

 

Company to host conference call and webcast today, August 10, at 4:30 pm ET

 

NEW YORK—August 10, 2023—Eyenovia, Inc. (NASDAQ: EYEN), an ophthalmic technology company commercializing Mydcombi™ (tropicamide+phenylephrine ophthalmic spray) for mydriasis and developing the Optejet® device for use both in connection with its own drug-device therapeutic product candidates for presbyopia and pediatric progressive myopia as well as out-licensing for additional indications, today announced its financial and operating results for the second quarter ended June 30, 2023.

 

Second Quarter 2023 and Recent Business Developments

 

·Announced first commercial sale of Mydcombi to world-renowned board-certified ophthalmologist Dr. Nathan M. Radcliffe, who becomes first to incorporate Mydcombi into his daily practice. The company will be following up with sales to key physicians in the upcoming weeks and preparing for national launch in early 2024.

 

·Advanced its pre-NDA presbyopia program, Apersure (Microline), and anticipates commencing the manufacture of registration batches in the fourth quarter of 2023.

 

·Continued to build out its manufacturing facilities in Redwood City, CA and Reno, NV, the former having a PDUFA date in November 2023 for use as a commercial facility.

 

·Delivered presentation at the annual OCTANE Ophthalmology Tech Forum 2023 reviewing the recent FDA approval of Mydcombi.

 

·Licensing partners Bausch+Lomb and Arctic Vision continued to enroll patients in their respective Phase 3 studies of Micropine (US and China) and Microline (China).

 

·Announced addition to widely followed Russell 2000 and Russell 3000 Indexes.

 

Michael Rowe, Chief Executive Officer, commented, “We achieved very significant milestones since our last quarterly update, notably the FDA approval and first commercial sale of Mydcombi, officially transitioning us to a commercial stage company. We are now executing a targeted launch of Mydcombi while in parallel ramping up our internal manufacturing capabilities in anticipation of a broader campaign incorporating our Gen 2 Optejet device beginning in 2024.

 

 

 

 

"Regarding our pre-NDA presbyopia candidate, Apersure, we continue to advance this important program following receipt of feedback from FDA that established a clear and efficient path forward. The addressable presbyopia market for topical ophthalmic medications is a nearly one-billion-dollar market opportunity in the US alone, and we believe an effective solution that leverages our novel Optejet drug delivery platform and fits within the business model of optometrists will be highly differentiated in the marketplace. We plan to initiate the manufacture of registration batches of Apersure during the fourth quarter.

 

“We believe the approval and commercial availability of Mydcombi will fundamentally transform the way that topical eye drugs are developed and delivered, as we now have critical validation of our Optejet platform that will benefit not only our proprietary development programs, most notably Apersure, but current and future partnerships as well. To that end, we continue to have very productive discussions with potential partners that could ultimately see the Optejet incorporated into additional large market ophthalmology indications with persistent unmet needs.

 

“I am extremely pleased with our progress to date and look forward to a productive back half of the year,” Mr. Rowe concluded.

 

Second Quarter 2023 Financial Review

 

For the second quarter of 2023, net loss was approximately $(6.2) million, or $(0.16) per share compared to a net loss of approximately $(7.2) million, or $(0.22) per share, for the second quarter of 2022.

 

Research and development expenses totaled approximately $2.8 million for the second quarter of 2023 as compared to $3.6 million for the second quarter of 2022.

 

For the second quarter of 2023, general and administrative expenses were approximately $3.1 million, compared to $3.5 million for the second quarter of 2022.

 

Total operating expenses for the second quarter of 2023 were approximately $6.0 million compared to $7.1 million for the second quarter of 2022.

 

As of June 30, 2023, the Company’s cash and cash equivalents were approximately $17.5 million compared to $22.9 million as of December 31, 2022.

 

Conference Call and Webcast

 

The conference call is scheduled to begin at 4:30 pm ET today, August 10. Participants should dial 1-877-407-9039 (domestic) or 1-201-689-8470 (international), and reference conference ID 13739696.

 

To access the Call me™ feature, which avoids having to wait for an operator, click here.

 

 

 

 

 

A live webcast of the conference call will also be available on the investor relations page of the Company's corporate website at www.eyenovia.com. After the live webcast, the event will be archived on Eyenovia’s website for one year.

 

IMPORTANT SAFETY INFORMATION for MYDCOMBI™ (tropicamide and phenylephrine hydrochloride ophthalmic spray) 1%/2.5%

 

INDICATIONS

 

MYDCOMBI is indicated to induce mydriasis for diagnostic procedures and in conditions where short term pupil dilation is desired

 

CONTRAINDICATIONS: In patients with known hypersensitivity to any component of the formulation

 

WARNINGS AND PRECAUTIONS

 

FOR TOPICAL OPHTHALMIC USE. NOT FOR INJECTION

 

This preparation may cause CNS disturbances which may be dangerous in pediatric patients. The possibility of psychotic reaction and behavioral disturbance due to hypersensitivity to anticholinergic drugs should be considered.

 

Mydriatics may produce a transient elevation of intraocular pressure.

 

Significant elevations in blood pressure have been reported. Caution in patients with elevated blood pressure.

 

Rebound miosis has been reported one day after installation.

 

Remove contact lenses before using.

 

DRUG INTERACTIONS

 

Atropine-like Drugs: May exaggerate the adrenergic pressor response

 

Cholinergic Agonists and Ophthalmic Cholinesterase Inhibitors: May interfere with the antihypertensive action of carbachol, pilocarpine, or ophthalmic cholinesterase inhibitors

 

Potent Inhalation Anesthetic Agents: May potentiate cardiovascular depressant effects of some inhalation anesthetic agents

 

ADVERSE REACTIONS

 

·Most common ocular adverse reactions include transient blurred vision, reduced visual acuity, photophobia, superficial punctate keratitis, and mild eye discomfort. Increased intraocular pressure has been reported following the use of mydriatics.

 

·Systemic adverse reactions including dryness of the mouth, tachycardia, headache, allergic reactions, nausea, vomiting, pallor, central nervous system disturbances and muscle rigidity have been reported with the use of tropicamide.

 

To report SUSPECTED ADVERSE REACTIONS, contact Eyenovia, Inc. At 1-833-393-6684 or FDA at 1-800-FDA-1088 (www.fda.gov/medwatch)

 

Please go to www.mydcombi.com for FULL PRESCRIBING INFORMATION

 

About Eyenovia, Inc.

 

Eyenovia, Inc. (NASDAQ: EYEN) is an ophthalmic pharmaceutical technology company developing a pipeline of microdose array print therapeutics. Eyenovia is currently focused on the commercialization of Mydcombi and the late-stage development of microdosed medications for presbyopia and myopia progression. For more information, visit www.eyenovia.com.

 

The Eyenovia Corporate Information slide deck may be found at ir.eyenovia.com/events-and-presentations.

 

 

 

 

 

Forward-Looking Statements

 

Except for historical information, all of the statements, expectations and assumptions contained in this press release are forward-looking statements. Forward-looking statements include, but are not limited to, statements that express our intentions, beliefs, expectations, strategies, predictions or any other statements relating to our future activities or other future events or conditions, including estimated market opportunities for our products, product candidates and platform technology. These statements are based on current expectations, estimates and projections about our business based, in part, on assumptions made by management. These statements are not guarantees of future performance and involve risks, uncertainties and assumptions that are difficult to predict. Therefore, actual outcomes and results may, and in some cases are likely to, differ materially from what is expressed or forecasted in the forward-looking statements. In addition, such statements could be affected by risks and uncertainties related to, among other things: risks of our clinical trials, including, but not limited to, the costs, design, initiation and enrollment, timing, progress and results of such trials; the timing of, and our ability to submit applications for, obtaining and maintaining regulatory approvals for our product candidates; the potential impacts of any disruptions on our supply chain, including the availability of sufficient components and materials used in our products and product candidates; the potential advantages of our products, product candidates and platform technology; the rate and degree of market acceptance and clinical utility of our products and product candidates; our estimates regarding the potential market opportunity for our products and product candidates; reliance on third parties to develop and commercialize our products and product candidates; the ability of us and our partners to timely develop, implement and maintain manufacturing, commercialization and marketing capabilities and strategies for our products and product candidates; intellectual property risks; changes in legal, regulatory and legislative environments in the markets in which we operate and the impact of these changes on our ability to obtain regulatory approval for our products; our competitive position; and other risks described from time to time in the “Risk Factors” section of our filings with the U.S. Securities and Exchange Commission, including those described in our Annual Report on Form 10-K as well as our Quarterly Reports on Form 10-Q, and supplemented from time to time by our Current Reports on Form 8-K. Any forward-looking statements speak only as of the date on which they are made, and except as may be required under applicable securities laws, Eyenovia does not undertake any obligation to update any forward-looking statements.

 

 

Eyenovia Contact:
Eyenovia, Inc.
John Gandolfo
Chief Financial Officer
jgandolfo@eyenovia.com

 

Eyenovia Investor Contact:
Eric Ribner
LifeSci Advisors, LLC
eric@lifesciadvisors.com
(646) 751-4363

 

Eyenovia Media Contact:
Eyenovia, Inc.

Norbert Lowe

Vice President, Commercial Operations

nlowe@eyenovia.com

 

 

 

 

 

 

EYENOVIA, INC. 

 

Condensed Balance Sheets

 

   June 30,   December 31, 
   2023   2022 
   (unaudited)     
Assets          
           
Current Assets          
Cash and cash equivalents  $17,468,088   $22,863,520 
Deferred clinical supply costs   3,578,326    2,284,931 
License fee and expense reimbursements receivable   429,006    1,183,786 
Security deposits, current   -    119,550 
Prepaid expenses and other current assets   1,801,373    1,190,719 
           
Total Current Assets   23,276,793    27,642,506 
           
Property and equipment, net   3,698,421    1,295,115 
Security deposits, non-current   198,674    80,874 
Operating lease right-of-use asset   1,915,061    1,291,592 
Equipment deposits   257,950    726,326 
           
Total Assets  $29,346,899   $31,036,413 
           
Liabilities and Stockholders' Equity          
           
Current Liabilities:          
Accounts payable  $1,312,749   $1,428,283 
Accrued compensation   1,013,118    1,747,191 
Accrued expenses and other current liabilities   363,431    503,076 
Operating lease liabilities - current portion   427,749    484,882 
Notes payable - current portion, net of debt discount of $91,621          
   and $33,885 as of June 30, 2023 and December 31, 2022, respectively   947,163    174,448 
Convertible notes payable - current portion, net of debt discount of $0          
   and $33,885 as of June 30, 2023 and December 31, 2022, respectively   -    174,448 
           
Total Current Liabilities   4,064,210    4,512,328 
           
Operating lease liabilities - non-current portion   1,584,218    907,644 
Notes payable - non-current portion, net of debt discount of $1,120,372          
      and $813,229 as of June 30, 2023 and December 31, 2022, respectively   8,683,794    4,190,938 
Convertible notes payable - non-current portion, net of debt discount of $507,270          
      and $813,229 as of June 30, 2023 and December 31, 2022, respectively   4,492,730    4,190,938 
           
Total Liabilities   18,824,952    13,801,848 
           
           
Stockholders' Equity:          
Preferred stock, $0.0001 par value, 6,000,000 shares authorized;          
0 shares issued and outstanding as of June 30, 2023 and          
December 31, 2022   -    - 
Common stock, $0.0001 par value, 90,000,000 shares authorized;          
38,169,398 and 36,668,980 shares issued and outstanding          
as of June 30, 2023 and December 31, 2022, respectively   3,817    3,667 
Additional paid-in capital   140,703,819    135,461,361 
Accumulated deficit   (130,185,689)   (118,230,463)
           
Total Stockholders' Equity   10,521,947    17,234,565 
           
Total Liabilities and Stockholders' Equity  $29,346,899   $31,036,413 

 

 

 

 

EYENOVIA, INC.

 

Condensed Statements of Operations

(unaudited)

 

   For the Three Months Ended   For the Six Months Ended 
   June 30,   June 30, 
   2023   2022   2023   2022 
                 
Operating Expenses:                    
Research and development  $2,811,061   $3,586,866   $5,333,011   $7,299,450 
General and administrative   3,149,809    3,534,590    6,086,695    7,009,555 
Total Operating Expenses   5,960,870    7,121,456    11,419,706    14,309,005 
Loss From Operations   (5,960,870)   (7,121,456)   (11,419,706)   (14,309,005)
                     
Other Income (Expense):                    
Other income, net   119,450    33,376    190,443    26,303 
Interest expense   (558,003)   (153,436)   (1,012,006)   (298,673)
Interest income   183,563    2,416    286,043    2,610 
                     
Net Loss  $(6,215,860)  $(7,239,100)  $(11,955,226)  $(14,578,765)
                     
Net Loss Per Share - Basic and Diluted  $(0.16)  $(0.22)  $(0.32)  $(0.46)
                     
Weighted Average Number of Common                    
Shares Outstanding                    
- Basic and Diluted   38,093,826    33,644,867    37,753,694    31,836,582 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

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