• Eyenovia Reports First Quarter 2023 Financial Results and Provides Business Update

    Source: Nasdaq GlobeNewswire / 11 May 2023 16:05:01   America/New_York

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

    Received feedback from FDA on its Phase 3 Microline presbyopia candidate that provides a clear and efficient path forward for the program

    Entered into co-development agreement with Formosa Pharmaceuticals for the potential development of new topical ophthalmic therapeutics

    Company to host conference call and webcast today, May 11, at 4:30 pm ET

    NEW YORK, May 11, 2023 (GLOBE NEWSWIRE) -- Eyenovia, Inc. (NASDAQ: EYEN), an ophthalmic technology company developing the Optejet delivery system for use both in combination with its own drug-device therapeutic programs for mydriasis, presbyopia and pediatric progressive myopia as well as out-licensing for additional indications, today announced its financial and operating results for the first quarter ended March 31, 2023.

    First Quarter 2023 and Recent Business Developments

    • Announced U.S. Food and Drug Administration (FDA) approval of Mydcombi, the Company’s proprietary combination microdose formulation of tropicamide and phenylephrine for inducing mydriasis for diagnostic procedures and in conditions where short term pupil dilation is desired. Please see the full prescribing information at www.mydcombi.com.
    • Received feedback from FDA on its Phase 3 Microline presbyopia candidate that provides a clear and efficient path forward for the program.
    • Entered into a development collaboration agreement with Formosa Pharmaceuticals to combine Eyenovia’s Optejet with Formosa’s APNT nanoparticle formulation platform for the potential development of new topical ophthalmic therapeutics.
    • Announced positive results from a research study, conducted in collaboration with Tufts Medical Center, demonstrating the superiority of the Optejet versus standard eye drops in the administration of the anti-glaucoma medication latanoprost preserved with benzalkonium chloride (BAK). Optejet was found to achieve a therapeutic dose of latanoprost with significantly less exposure to excess drug and harmful preservatives than can be achieved using conventional drops. These results were presented at the Association for Research in Vision and Ophthalmology (ARVO) 2023 annual meeting in April.
    • Continued to build out its manufacturing facilities in Redwood City, CA and Reno, NV, which is on track to come online during the third quarter of 2023.
    • 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).
    • Ended the first quarter of 2023 with approximately $18.5 million in total cash and cash equivalents. In addition, with the approval of Mydcombi, the Company has the ability to draw down an additional $5 million on its credit facility with Avenue Capital before July 31, 2023.

    Michael Rowe, Chief Executive Officer, commented, "We are proud to be delivering on our commitments in 2023 with the recently announced FDA approval of Mydcombi, our first approved product dispensed using our Optejet technology. We believe the Optejet will transform the way that topical eye drugs are developed and delivered, and this FDA approval marks a significant milestone in its evolution. It is also an important achievement in the context of our current and future partnerships, providing a template for the development of additional ophthalmic therapies administered via the Optejet in high-value ophthalmic indications."

    "Regarding our pre-NDA Microline program for presbyopia, we received clear feedback from the FDA that provides an efficient path forward for the program. We are in the process of completing the build-out and validation of our Redwood City manufacturing facility and remain on track to commence the manufacture of launch batches early next year. In the interim, we plan to conduct supportive human factors testing and clinical work demonstrating the usability of the Gen-2 Optejet device, which has been optimized for in-home use.”

    “With one product approved, and line-of-sight toward a second, we have reached a true inflection point in the evolution of our company. Having an FDA approved product not only provides critical validation of our Optejet technology for our own advanced clinical programs, but also our partnerships as well. To that end, we continue to advance discussions with additional partners that could potentially assess the utility of Optejet in very large indications such as glaucoma and dry eye, among others. I am pleased with our progress to date and look forward to initial commercial sales of Mydcombi this summer together with continued clinical and regulatory progress for us and our partners.”

    First Quarter 2023 Financial Review

    For the first quarter of 2023, net loss was approximately $(5.7) million, or $(0.15) per share compared to a net loss of approximately $(7.3) million, or $(0.24) per share, for the first quarter of 2022.

    Research and development expenses totaled approximately $2.5 million for the first quarter of 2023 as compared to $3.7 million for the first quarter of 2022.

    For the first quarter of 2023, general and administrative expenses were approximately $2.9 million, compared to $3.5 million for the first quarter of 2022.

    Total operating expenses for the first quarter of 2023 were approximately $5.5 million compared to $7.2 million for the first quarter of 2022.

    As of March 31, 2023, the Company’s cash and cash equivalents were approximately $18.5 million compared to $22.9 million as of December 31, 2022. In addition, with the approval of Mydcombi, the Company has the ability to draw down an additional $5 million on its credit facility with Avenue Capital before July 31, 2023.

    Conference Call and Webcast

    The conference call is scheduled to begin at 4:30 pm ET today, May 11. Participants should dial 1-877-407-9039 (domestic) or 1-201-689-8470 (international). 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.

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

    After the live webcast, the event will be archived on Eyenovia’s website for one year.

    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.

    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
       March 31, December 31,
       2023 2022
       (unaudited)  
    Assets
       
          
    Current Assets:   
     Cash and cash equivalents$18,466,322  $22,863,520 
     Deferred clinical supply costs 3,352,645   2,284,931 
     License fee and expense reimbursements receivable 973,677   1,183,786 
     Security deposits, current 119,550   119,550 
     Prepaid expenses and other current assets 2,011,884   1,190,719 
          
      Total Current Assets 24,924,078   27,642,506 
          
    Property and equipment, net 2,152,861   1,295,115 
    Security deposits, non-current 80,874   80,874 
    Operating lease right-of-use asset 1,508,158   1,291,592 
    Equipment deposits 643,513   726,326 
          
      Total Assets$29,309,484  $31,036,413 
          
    Liabilities and Stockholders' Equity   
          
    Current Liabilities:   
     Accounts payable$1,402,076  $1,428,283 
     Accrued compensation 637,189   1,747,191 
     Accrued expenses and other current liabilities 460,143   503,076 
     Operating lease liabilities - current portion 472,901   484,882 
     Notes payable - current portion, net of debt discount of $123,480   
     and $33,885 as of March 31, 2023 and December 31, 2022, respectively 1,218,963   174,448 
     Convertible notes payable - current portion, net of debt discount of $123,480  
     and $33,885 as of March 31, 2023 and December 31, 2022, respectively 709,853   174,448 
          
      Total Current Liabilities 4,901,125   4,512,328 
          
    Operating lease liabilities - non-current portion 1,133,948   907,644 
    Notes payable - non-current portion, net of debt discount of $648,889   
    and $813,229 as of March 31, 2023 and December 31, 2022, respectively 3,730,278   4,190,938 
    Convertible notes payable - non-current portion, net of debt discount of $648,889  
    and $813,229 as of March 31, 2023 and December 31, 2022, respectively 3,730,278   4,190,938 
          
      Total Liabilities 13,495,629   13,801,848 
          
    Stockholders' Equity:   
     Preferred stock, $0.0001 par value, 6,000,000 shares authorized;   
     0 shares issued and outstanding as of March 31, 2023 and   
     December 31, 2022 -   - 
     Common stock, $0.0001 par value, 90,000,000 shares authorized;   
     37,991,746 and 36,668,980 shares issued and outstanding   
     as of March 31, 2023 and December 31, 2022, respectively 3,799   3,667 
     Additional paid-in capital 139,779,885   135,461,361 
     Accumulated deficit (123,969,829)  (118,230,463)
          
      Total Stockholders' Equity 15,813,855   17,234,565 
          
      Total Liabilities and Stockholders' Equity$29,309,484  $31,036,413 
          

     

     
    EYENOVIA, INC.
    Condensed Statements of Operations
    (unaudited)
          
       For the Three Months Ended
       March 31,
       2023 2022
          
    Operating Expenses:   
     Research and development$2,521,950  $3,712,584 
     General and administrative 2,936,886   3,474,965 
      Total Operating Expenses 5,458,836   7,187,549 
          
      Loss From Operations (5,458,836)  (7,187,549)
          
    Other Income (Expense):   
     Other income (expense), net 70,993   (7,073)
     Interest expense (454,003)  (145,237)
     Interest income 102,480   194 
          
      Net Loss$(5,739,366) $(7,339,665)
          
    Net Loss Per Share - Basic and Diluted$(0.15) $(0.24)
          
    Weighted Average Number of Common   
     Shares Outstanding   
      - Basic and Diluted 37,410,587   30,008,194 
          

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