Full Press Release Details
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,
November 10, at 4:30 pm ET
NEW YORK-November 10,
2022-Eyenovia, Inc. (Nasdaq: EYEN), a pre-commercial 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 third quarter
ended September 30, 2022.
Third Quarter 2022 and Recent Business Developments
Michael Rowe, Chief Executive
Officer, commented, "Since our last quarterly update, we achieved a significant milestone with positive results from VISION-2, our
second Phase 3 trial of MicroLine, a potential topical, on-demand therapeutic that we are developing as a temporary treatment for presbyopia.
We are planning to meet with the FDA early next year followed by the manufacture of registration batches at our new, state-of-the-art
facility in Redwood City, CA."
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 China. This study, when complete in late 2023, is expected to add to the growing body of evidence demonstrating
the safety and efficacy of MicroLine and Optejet. We continue to evaluate additional opportunities to partner or collaborate in other
high value ophthalmic indications where the Optejet technology can be used to improve medical care."
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 $(7.3) million, or $(0.21) per share compared to a net loss of approximately $(5.6) million, or $(0.21)
per share, for the third quarter of 2021.
Research and development
expenses totaled approximately $3.9 million for the third quarter of 2022 as compared to $3.6 million for the third quarter of 2021, an
increase of approximately 9.1%.
For the third quarter
of 2022, general and administrative expenses were approximately $3.4 million, compared to $2.4 million for the third quarter of 2021,
an increase of approximately 41.3%.
Total operating expenses
for the third quarter of 2022 were approximately $7.2 million compared to $5.9 million for the third quarter of 2021. This represents
an increase of approximately 22.0 %.
2022, the Company's cash and cash equivalents were approximately $25.3 million, including $7.9 million of restricted cash, as compared
to $27.3 million as of December 31, 2021.
Conference Call and Webcast
The conference call is
scheduled to begin at 4:30 pm ET today, November 10. Participants should dial 1-866-575-6539 (domestic) or 1-929-477-0448 (international)
with the conference code 1600616. 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.
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. Eyenovia believes that its administration of pilocarpine using
the Company's high precision microdosing technology could provide a meaningful improvement in near vision while enhancing tolerability
and usability. MicroLine has been licensed to Arctic Vision (Hong Kong) Limited in Greater China and South Korea.
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 the United States and Canada, and Arctic Vision (Hong Kong) Limited in Greater China and South Korea.
About Mydcombi for Mydriasis
Mydcombi is Eyenovia's
investigational, first-in-class fixed-dose-combination product (tropicamide 1% and phenylephrine 2.5% ophthalmic spray) for pharmacologic
mydriasis (eye dilation), which is targeted to improve the efficiency of the estimated 100 million office-based comprehensive eye exams
performed every year in the United States, as well as the estimated 4 million pharmacologic mydriasis applications for cataract surgery.
Developed as a micro-formulation for use without anesthetic, Eyenovia believes Mydcombi will help improve the efficacy, tolerability,
and efficiency of pharmacologic mydriasis. Mydcombi has been licensed to Arctic Vision (Hong Kong) Limited in Greater China and South
About Optejet and Microdose
Array Print (MAP ) Therapeutics
Eyenovia's Optejet microdose
formulation and delivery platform for ocular therapeutics uses high-precision piezo-print technology to deliver 6-8 L of drug, consistent
with the capacity of the tear film of the eye. We estimate the volume of ophthalmic solution administered with the Optejet is less than
20% of that delivered using conventional eyedroppers, thus reducing overdosing and exposure to drug and preservatives. Eyenovia's patented
microfluidic ejection technology is designed for fast and gentle ocular surface delivery, where solution is dispensed to the ocular surface
in approximately 80 milliseconds, beating the ocular blink reflex. Successful use of the Optejet has been demonstrated more than 85% of
the time after basic training in a variety of clinical settings compared to 40 - 50% historically seen with conventional eyedroppers.
Additionally, its smart electronics and mobile e-health technology are designed to track and enhance patient compliance.
About Eyenovia, Inc.
Eyenovia, Inc. (Nasdaq:
EYEN) is an pre-commercial ophthalmic technology company developing a pipeline of microdose array print (MAP) therapeutics. Eyenovia is
currently focused on the late-stage development of microdosed medications for mydriasis, presbyopia and myopia progression. For more information,
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 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;