Full Press Release Details
Eyenovia Reports First Quarter 2022 Financial
Mydcombi NDA resubmission on track for Q3
Phase 3 VISION-2 study evaluating MicroLine as
an on-demand treatment for improving near vision (presbyopia) progressing as planned; topline data expected mid-year
Ended Q1 with sufficient cash and cash equivalents
for the potential launch of Mydcombi and completion of the VISION program
Company to host conference call and webcast today,
May 12, at 4:30pm ET
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 first
quarter ended March 31, 2022.
First Quarter 2022 and Recent Business Developments
Dr. Sean Ianchulev, Chairman,
Chief Executive Officer and Chief Medical Officer of Eyenovia, commented, "During the first quarter, we made excellent progress
on the additional Optejet device validation testing requested by FDA as part of our Mydcombi NDA, and we remain on track for resubmission
during the third quarter of this year. In parallel, our VISION-2 trial for our MicroLine presbyopia program continues to progress as planned,
and we anticipate topline data mid-year."
"The recent commercial
launch of a presbyopia eye drop product by a competitor, supported by a robust direct-to-consumer advertising and awareness campaign,
will help create a market that we estimate to be worth multiple billions of dollars. However, MicroLine, if and when commercially available,
will be the only product that will leverage our proprietary Optejet dispensing technology, which has been shown in the VISION-1 study
to cause a very low rate of headache, and is both easier and neater to administer than an eye drop."
to achieve very significant milestones in 2022 that give us potential line of sight to two commercially approved products. We are off
to a strong start, and I am excited about all that we can achieve this year."
First Quarter 2022 Financial Review
For the first quarter
of 2022, net loss was approximately $(7.3) million, or $(0.24) per share compared to a net loss of approximately $(5.4) million, or $(0.21)
per share, for the first quarter of 2021.
Total license revenue
was $0.00 for the first quarter of 2022 as compared to $2.0 million for the first quarter of 2021.
Research and development
expenses totaled approximately $3.7 million for the first quarter of 2022 as compared to $4.3 million for the first quarter of 2021.
For the first quarter
of 2022, general and administrative expenses were approximately $3.5 million, compared to $2.2 million for the first quarter of 2021.
Total operating expenses
for the first quarter of 2022 were approximately $7.2 million compared to $6.6 million for the first quarter of 2021.
As of March 31, 2022,
the Company's cash and cash equivalents were approximately $34.6 million, including $7.9 million of restricted cash, as compared
to $27.3 million as of December 31, 2021. As of March 31, 2022, cash included $15 million raised through the securities purchase agreement
with Armistice Capital in March.
Conference Call and Webcast
The conference call is
scheduled to begin at 4:30pm ET today, May 12. Participants should dial 877-207-9876 (domestic) or 212-231-2932 (international) with the
conference code 22018217. 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. 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
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 Health
Companies, 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
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 and resulting social distancing), timing,