Full Press Release Details
Eyenovia Reports Third Quarter 2021 Financial
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, November 11, at 5:00pm ET
YORK-November 10, 2021-Eyenovia, Inc. (NASDAQ: EYEN), a clinical stage ophthalmic company developing a pipeline of
advanced therapeutics based on its proprietary microdose array print (MAP ) platform technology, today announced its financial results
for the third quarter ended September 30, 2021.
Third Quarter 2021 and Recent Business Developments
Dr. Sean Ianchulev, Chief Executive Officer and
Chief Medical Officer of Eyenovia, commented, "Over the past weeks we have made excellent progress preparing the additional information
requested by the FDA pertaining to our MydCombi NDA. As noted previously, throughout development of MydCombi, we had taken actions to
minimize the potential impact of a reclassification of MydCombi to a drug-device combination. These efforts are now proving to be invaluable
and, importantly, the additional information we are now submitting related to our Optejet dispenser should streamline regulatory review
of our other late-stage development programs, MicroLine and MicroPine, that also leverage this technology. We remain confident in our
ability to resubmit the MydCombi NDA in early 2022."
"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. Fred Eshelman, from our Board. On behalf of the entire Company, I would like to thank Dr. Eshelman for his
years of distinguished service and many contributions. The Company intends to engage in a thorough search process to recruit one or more
new members to its Board, with particular emphasis on medical, ophthalmological and drug development expertise, prior public company Board
experience, corporate governance and capital markets credentials and/or diversity."
"As of today, we believe we are sufficiently
capitalized with approximately $30 million in unrestricted and restricted cash to cover the Company's planned expenses for Mydcombi,
MicroLine and MicroPine throughout 2022. In addition, we look forward to delivering potentially value creating milestones in 2022 and
into 2023," Dr. Ianchulev concluded.
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 September 30, 2021 totaled $3.5 million, an increase of 3.2%, as compared to $3.4 million recorded for the three
months ended September 30, 2020.
For the third quarter of 2021, general and administrative
expenses for the three months ended September 30, 2021 totaled $2.4 million, an increase of 40.1%, as compared to $1.7 million
recorded for the three months ended September 30, 2020.
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
conference call is scheduled to begin at 5:00pm ET on Thursday, November 11, 2021. Participants should dial 877-407-9039 (domestic) or
201-689-8470 (international) with the conference code 13724626. 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 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. 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 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 the United
States and Canada, and Arctic Vision (Hong Kong) Limited in Greater China and South Korea.
About MyCombi for Mydriasis
MydCombi is Eyenovia's investigational, first-in-class
fixed-dose-combination product (tropicamide 1% and phenylephrine 2.5% ophthalmic solution) 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 Korea.
About Optejet and Microdose Array Print
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 ophthalmic
pharmaceutical 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, visit 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 product candidates and platform technology. These statements are based on current expectations, estimates and projections about