Eyenovia Reports Third Quarter 2021 Financial Results
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Eyenovia Reports Third Quarter 2021 Financial Results
On track with VISION-2 phase 3 presbyopia trial and expedited resubmission of MydCombi™ New Drug Application as a drug/device combination in early 2022
Current cash resources anticipated to be sufficient to cover MydCombi NDA resubmission, completion of Phase 3 MicroLine program, and completion of manufacturing facility
Company to host conference call and webcast tomorrow,
Third Quarter 2021 and Recent Business Developments
- Announced that the first patient has been enrolled in VISION-2, a second Phase 3 trial of MicroLine, the Company’s proprietary investigational pilocarpine spray for the treatment of presbyopia, with topline data expected in mid-2022.
- Announced that Dr.
Fred Eshelman, who has served as Chairman of the Eyenovia Board since 2014, will step down by the end of 2021 to pursue other professional interests.
July 22, 2021, Eyenoviaprovided an update on the Company’s MicroLine program at Eyecelerator, a joint venture between the American Academy of Ophthalmology(AAO) and the American Society of Cataract and Refractive Surgery(ASCRS).
September 14, 2021, Arctic Vision and Eyenoviaexpanded an existing licensing agreement to include MydCombi. All three of Eyenovia’s current programs have now been out licensed to Arctic Vision for the greater Chinaand Korean markets.
October 25, 2021, Eyenoviaannounced that it had received notice from the U.S. Food and Drug Administration(FDA) in the form of a Complete Response Letter (CRL) that MydCombi has been reclassified as a drug-device combination product as part of the agency’s review of the MydCombi New Drug Application (NDA).
- The Company is working to furnish additional information to the FDA for expedited resubmission of the NDA in early 2022 and continues to believe that, if approved, MydCombi represents a significant advancement for mydriasis (pupil dilation).
- Granted additional international patents related to the Optejet® dispenser.
Eyenovianow has a total of 13 patents for the technology in the United Statesand over 80 international patents.
“In parallel, we remain acutely focused on completing enrollment in our recently initiated second Phase 3 trial of MicroLine for presbyopia, VISION-2. If positive, the VISION program will support submission of a MicroLine NDA, giving us potential line-of-sight to two approved products in the relative near-term, should both applications be successful.”
“We are also announcing the departure of our friend and supporter, Dr.
“As of today, we believe we are sufficiently capitalized with approximately
Third Quarter 2021 Financial Review
For the third quarter of 2021, net loss was approximately $5.6 million, or $(0.21) per share, compared to a net loss of approximately $5.1 million, or $(0.23) per share, for the third quarter of 2020.
Research and development expenses for the three months ended
For the third quarter of 2021, general and administrative expenses for the three months ended
Total operating expenses for the third quarter of 2021 were approximately $5.9 million, compared to total operating expenses of approximately $5.1 million for the same period in 2020, an increase of approximately 16%.
As of September 30, 2021, the Company’s unrestricted and restricted cash balance was approximately $21.4 million.
Conference Call and Webcast
The conference call is scheduled to begin at
After the live webcast, the event will be archived on Eyenovia’s website for one year.
About the VISION Trials
The VISION trials are Phase 3, double-masked, placebo-controlled, cross-over superiority trials that enroll participants with presbyopia. The primary endpoint is improvement in high-contrast binocular distance corrected near visual acuity in low light conditions. MicroLine is intended for the “on demand” improvement of near vision in people with presbyopia.
About MicroLine for Presbyopia
MicroLine (pilocarpine ophthalmic solution) is Eyenovia’s investigational pharmacologic treatment for presbyopia. Presbyopia or farsightedness is the non-preventable, age-related hardening of the lens, which causes a gradual loss of the eye’s ability to focus on nearby objects and is estimated to affect nearly 113 million Americans. Treatment options are typically device-based, such as reading glasses and contact lenses. Pilocarpine ophthalmic solution is known to constrict the pupil and improve near-distance vision by creating an extended depth of focus through its small aperture effect.
About MicroPine for Progressive Myopia
MicroPine (atropine ophthalmic solution) is Eyenovia’s investigational, potentially first-in-class topical treatment for the reduction of pediatric myopia progression, also known as nearsightedness, in children ages 3-12. It has been developed for comfort and ease-of-use in children, and its microdose administration is designed to potentially result in low systemic and ocular drug exposure. MicroPine has been licensed to Bausch Health Companies, Inc. in
About MyCombi™ for Mydriasis
About Optejet® and Microdose Array Print (MAP™) Therapeutics
The Eyenovia Corporate Information slide deck may be found at ir.eyenovia.com/events-and-presentations.
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 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 due to numerous factors discussed from time to time in documents which we file with the U.S. Securities and Exchange Commission. 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 (which could still be adversely impacted by COVID-19 and resulting social distancing), 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 COVID-19 on our supply chain; the potential advantages of our product candidates and platform technology; the rate and degree of market acceptance and clinical utility of our product candidates; our estimates regarding the potential market opportunity for our product candidates; reliance on third parties to develop and commercialize our product candidates; the ability of us and our partners to timely develop, implement and maintain manufacturing, commercialization and marketing capabilities and strategies for our 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; and our competitive position. 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.
Chief Financial Officer
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|Condensed Balance Sheets|
|Cash and cash equivalents||$||13,500,871||$||28,371,828|
|Deferred license costs||-||1,600,000|
|License fee and expense reimbursements receivables||960,180||2,966,039|
|Prepaid expenses and other current assets||1,123,289||453,478|
|Total Current Assets||23,459,340||33,391,345|
|Property and equipment, net||1,413,201||396,380|
|Liabilities and Stockholders' Equity|
|Accrued expenses and other current liabilities||552,336||1,480,692|
|Deferred rent - current portion||16,037||7,809|
|Deferred license fee||10,000,000||14,000,000|
|Notes payable - current portion||7,282,037||97,539|
|Total Current Liabilities||20,719,379||18,198,377|
|Deferred rent - non-current portion||26,059||38,684|
|Notes payable - non-current portion||-||365,814|
|Commitments and contingencies|
|0 shares issued and outstanding as of
|25,963,185 and 24,978,585 shares issued and outstanding|
|Additional paid-in capital||97,446,125||92,742,306|
|Total Stockholders' Equity||4,246,138||15,303,885|
|Total Liabilities and Stockholders' Equity||$||24,991,576||$||33,906,760|
|Condensed Statements of Operations|
|For the Three Months Ended||For the Nine Months Ended|
|Cost of revenue||-||-||(1,600,000||)||-|
|Research and development||3,470,188||3,363,759||11,334,296||9,913,296|
|General and administrative||2,435,141||1,728,366||7,082,659||5,669,311|
|Total Operating Expenses||5,905,329||5,092,125||18,416,955||15,582,607|
|Loss From Operations||(5,905,329||)||(5,092,125||)||(16,016,955||)||(15,582,607||)|
|Other Income (Expense):|
|Small Business Administration Economic|
|Injury Disaster Grant||-||-||-||10,000|
|Extinguishment of PPP 7(a) loan||463,353||-||463,353||-|
|Net Loss Per Share|
|- Basic and Diluted||$||(0.21||)||$||(0.23||)||$||(0.61||)||$||(0.79||)|
|Weighted Average Number of|
|Common Shares Outstanding|
|- Basic and Diluted||26,053,532||22,206,195||25,773,098||19,802,999|
Source: Eyenovia, Inc.