Eyenovia Reports Third Quarter 2022 Financial Results and Provides Business Update
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Eyenovia Reports Third Quarter 2022 Financial Results and Provides Business Update
Announced positive results from the second Phase 3 study of MicroLine in presbyopia, VISION-2; Company planning to meet with the FDA to gain alignment on regulatory path forward as a drug/device combination product
Company to host conference call and webcast today,
Third Quarter 2022 and Recent Business Developments
- Announced that in a modified per-protocol analysis of evaluable patients, VISION-2 met its primary endpoint with a statistically significant proportion of MicroLine-treated subjects showing a ≥15-letter improvement in distance corrected near visual acuity (DCNVA) with less than a 5-letter loss in distance acuity versus placebo in low light conditions at two hours post-treatment. The study also achieved all secondary endpoints and the Company is planning to meet with the FDA as soon as practicable.
- Development partner Arctic Vision continues to enroll patients in its Phase 3 study of MicroLine (ARVN003) as a potential treatment for presbyopia in
China. Arctic Vision anticipates completing the study in late 2023.
- Announced data at the 40th
Congressof the European Society Of Cataract and Refractive Surgeons (ESCRS) in September 2022demonstrating that preserved drugs delivered with the Optejet act more like unpreserved drugs, reducing ocular stress and potentially avoiding long-term adverse events.
- Announced the appointment of Eyenovia’s former Chief Operating Officer,
Michael Rowe, as the Company’s new Chief Executive Officer. Mr. Rowewas also appointed to Eyenovia’s Board of Directors.
- Announced that the Company’s new manufacturing facility in
Redwood City, CAis now operational, and also announced the appointment of Bren Kernas Senior Vice President of Operations.
- Ended the third quarter of 2022 with approximately
$25.3 millionin total cash and cash equivalents, including $7.9 millionof restricted cash.
“Our collaboration and license agreements with Bausch+Lomb and Arctic Vision are progressing nicely, and Arctic Vision continues to enroll patients in its own Phase 3 trial of MicroLine in
“We believe we have set the stage for achievement of multiple key milestones in 2023, and we will work tirelessly to sustain the momentum that we currently enjoy.”
Third Quarter 2022 Financial Review
For the third quarter of 2022, net loss was approximately
Research and development expenses totaled approximately
For the third quarter of 2022, general and administrative expenses were approximately
Total operating expenses for the third quarter of 2022 were approximately
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 spray) 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. 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 spray) 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+Lomb, Inc. in
About Mydcombi™ 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. 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), 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 and related economic disruptions on our supply chain, including the availability of sufficient components and materials used in our product candidates; 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; our competitive position; and other risks described from time to time in the “Risk Factors” section of our filings with the
Chief Financial Officer
Eyenovia Investor Contact:
Eyenovia Media Contact:
Vice President, Commercial Operations
|Condensed Balance Sheets|
|Cash and cash equivalents||$||17,398,605||$||19,461,850|
|Deferred clinical supply costs||1,871,096||-|
|License fee and expense reimbursements receivable||809,430||1,805,065|
|Prepaid expenses and other current assets||1,463,020||721,438|
|Total Current Assets||29,417,151||29,863,353|
|Property and equipment, net||1,342,657||1,271,225|
|Liabilities and Stockholders' Equity|
|Accrued expenses and other current liabilities||1,384,803||845,719|
|Deferred rent - current portion||28,999||18,685|
|Total Current Liabilities||11,015,783||11,172,494|
|Deferred rent - non-current portion||60,540||19,949|
|0 shares issued and outstanding as of
|35,525,689 and 28,426,616 shares issued and outstanding|
|Additional paid-in capital||132,432,682||110,683,077|
|Total Stockholders' Equity||20,329,168||20,466,615|
|Total Liabilities and Stockholders' Equity||$||31,405,491||$||31,659,058|
|Condensed Statements of Operations|
|For the Three Months Ended||For the Nine Months Ended|
|Cost of revenue||-||-||-||(1,600,000||)|
|Research and development||3,876,876||3,552,068||11,176,326||11,559,364|
|General and administrative||3,353,352||2,372,999||10,362,907||6,914,481|
|Total Operating Expenses||7,230,228||5,925,067||21,539,233||18,473,845|
|Loss From Operations||(7,230,228||)||(5,925,067||)||(21,539,233||)||(16,073,845||)|
|Other Income (Expense):|
|Extinguishment of PPP 7(a) loan||-||463,353||-||463,353|
|Other income, net||70,277||11,728||96,580||48,880|
|Net Loss Per Share - Basic and Diluted||$||(0.21||)||$||(0.21||)||$||(0.67||)||$||(0.61||)|
|Weighted Average Number of Common|
|- Basic and Diluted||34,631,774||26,053,532||32,778,551||25,773,098|
Source: Eyenovia, Inc.