Full Press Release Details
Eyenovia Reports First Quarter 2021 Financial
MydCombi PDUFA date confirmed for October 28,
Completed patient enrollment in Phase 3 VISION-1
study evaluating MicroLine for the treatment of presbyopia; top-line data on track for Q2
Secures $25 million credit facility through
Company to host conference call and webcast
today, May 12, at 4:30pm ET
NEW YORK-May 12, 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 first quarter ended March 31, 2021.
First Quarter 2021 and Recent Business Highlights
Dr. Sean Ianchulev, Chief Executive Officer and
Chief Medical Officer of Eyenovia, commented, "The Eyenovia team has made substantial progress in advancing towards its clinical,
regulatory, and commercial goals during the first quarter of 2021. We look forward to our PDUFA date for MydCombi on October 28th
of this year. In preparation for the anticipated approval, we were pleased to announce an exclusive agreement with EVERSANA to help lead
distribution of MydCombi in the United States. If approved, MydCombi would be the first microdosed ocular therapeutic applied with
our proprietary high precision smart delivery system, the Optejet ."
"Regarding our Phase 3 VISION-1 clinical
study evaluating our proprietary pilocarpine formulation, MicroLine, which is also delivered via the Optejet, for the improvement of near
vision in patients with presbyopia, we have completed patient enrollment and anticipate top-line results in the coming weeks. We remain
focused on advancing our late-stage clinical programs, while preparing to transition into a commercial-stage ophthalmology company. I
believe we have set the stage for a transformational year in 2021," concluded Dr. Ianchulev.
First Quarter 2021 Financial Review
For the first quarter of 2021, net loss was approximately $5.4
million, or $(0.21) per share, compared to a net loss of approximately $5.5 million, or $(0.31) per share, for
the first quarter of 2020.
For the first quarter of 2021, the Company reported
license fee revenue of $2.0 million from its license agreement with Arctic Vision (Hong Kong) Limited and a corresponding cost of revenue
representing payments to Senju Pharmaceutical Co., Ltd. of $800,000.
Research and development expenses totaled approximately $4.2
million for the first quarter of 2021, compared to approximately $3.6 million for the same period in 2020, an increase
of approximately 16.9%.
For the first quarter of 2021, general and administrative
expenses were approximately $2.3 million compared to approximately $1.8 million for the first quarter of 2020, an
increase of approximately 25.2%.
Total operating expenses for the first quarter
of 2021 were approximately $6.5 million, compared to total operating expenses of approximately $5.5 million for the same
period in 2020, an increase of approximately 19.7%.
As of March 31, 2021, the Company's
cash balance was approximately $24.9 million. Subsequent to the end of the first quarter, the Company announced a credit facility
of up to $25 million through Silicon Valley Bank (SVB). The first tranche of $7.5 million was advanced to Eyenovia upon closing of the
facility. The remaining two tranches ($7.5 million and $10.0 million) will be available to the Company subject to the satisfaction of
certain milestones and covenants as outlined in the credit agreement.
Conference Call and Webcast
The conference call is scheduled to begin at
4:30pm ET on Wednesday, May 12, 2021. Participants should dial 877-407-9039 (domestic) or 201-689-8470 (international) with the conference
code 13718776. 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 Eyenovia, Inc.
Eyenovia, Inc. (NASDAQ:
EYEN) is a clinical stage ophthalmic company developing a pipeline of advanced therapeutics based on its proprietary microdose array
print (MAP ) platform technology. Eyenovia is currently focused on the late-stage development of medications for presbyopia,
myopia progression and mydriasis. For more Information, visit www.eyenovia.com.
About MicroLine for Presbyopia
MicroLine is a pharmacologic
treatment for presbyopia. Presbyopia 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. Current 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.
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 MicroStat (MyCombi ) for Mydriasis
MydCombi is Eyenovia's first-in-class
fixed-combination micro-formulation product (tropicamide 1% - phenylephrine 2.5%) candidate for pharmacologic mydriasis (eye dilation),
which is targeted to improve the efficiency of the estimated 80 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 for use without
anesthetic, Eyenovia is developing MicroStat to help improve the efficacy and tolerability of pharmacologic mydriasis.
Microdose Array Print (MAP ) Therapeutics
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 believe the volume of ophthalmic solution administered with the Optejet
is less than 75% 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% with conventional eyedroppers. Additionally,
its smart electronics and mobile e-health technology are designed to track and enhance patient compliance.
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 regulatory review timing,
and 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 are likely
to, differ materially from what is expressed or forecasted in the forward-looking statements due to numerous factors discussed from time
to time in documents which we file with the U.S. Securities and Exchange Commission. In addition, such statements could be affected
by risks and uncertainties related to, among other things: fluctuations in our financial results; volatility and uncertainty in the global
economy and financial markets in light of the evolving COVID-19 pandemic; our ability to raise additional money to fund our operations
for at least the next 12 months as a going concern; our estimates regarding the potential market opportunity for our product candidates
and potential revenue from licensing transactions; reliance on third parties; risks of our and our licensees' 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, progress and results of such trials; the potential impacts of COVID-19 on our supply chain; the timing and our and
our licensees' ability to submit applications for, obtain and maintain regulatory approvals for our product candidates; changes