Full Press Release Details
Eyenovia Reports Second Quarter 2022 Financial
Announced appointment of Michael Rowe as Chief
Executive Officer and Board member
Mydcombi NDA resubmission on track for the
fourth quarter of 2022
Phase 3 VISION-2 study evaluating MicroLine as
an on-demand treatment for improving near
vision (presbyopia) progressing as planned; topline data expected in the third quarter of 2022
Company to host conference call and webcast today,
August 10, at 4:30 pm ET
10, 2022-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 and operating results for the
second quarter ended June 30, 2022.
Second Quarter 2022 and Recent Business Developments
Dr. Sean Ianchulev, Chairman
of the Board of Directors, commented, "We achieved significant progress during the second quarter and subsequent period across both
our Mydcombi and MicroLine programs, and we are very fortunate to have concluded our CEO search with the appointment of Michael Rowe who
we believe is the ideal candidate to sustain our current momentum. His appointment maintains continuity while bringing significant ophthalmic
operations and commercialization expertise to the role ahead of significant regulatory and clinical milestones. These include the pending
resubmission of our Mydcombi New Drug Application and near completion of our second Phase 3 presbyopia trial, each of which moves us a
step further to transitioning to a commercial stage company."
Michael Rowe, Chief Executive
Officer, commented, "We are nearing completion of the additional Optejet device validation testing requested by the FDA when Mydcombi
was reclassified as a drug-device combination product. Global supply chain issues that have impacted most high technology manufacturers
and delayed the production of our validation units have now been resolved. As a result, we now anticipate resubmitting our NDA to the
FDA during the fourth quarter of 2022. If approved next year, Mydcombi for mydriasis would be the first commercial product to leverage
our Optejet dispensing technology, a significant achievement for our Company. With our presbyopia program also progressing, and our Redwood
City manufacturing operations up and running, this is indeed a transformational time for our Company. I am pleased with the progress made
addressing these challenges during the second quarter and look forward to a productive back half of the year."
Second Quarter 2022 Financial Review
For the second quarter
of 2022, net loss was approximately $(7.2) million, or $(0.22) per share compared to a net loss of approximately $(4.8) million, or $(0.19)
per share, for the second quarter of 2021.
Total license revenue
was $0.0 million for the second quarter of 2022 as compared to $2.0 million for the second quarter of 2021.
Research and development
expenses totaled approximately $3.6 million for the second quarter of 2022 as compared to $3.7 million for the second quarter of 2021,
a decrease of approximately (2.7%).
For the second quarter
of 2022, general and administrative expenses were approximately $3.5 million, compared to $2.3 million for the second quarter of 2021,
an increase of approximately 53.8%.
Total operating expenses
for the second quarter of 2022 were approximately $7.1 million compared to $6.0 million for the second quarter of 2021. This represents
an increase of approximately 19.0%.
As of June 30, 2022,
the Company's cash and cash equivalents were approximately $29.4 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, August 10. Participants should dial 877-407-9039 (domestic) or 201-689-8470 (international) with
the conference code 13731733. 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
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,
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