Full Press Release Details
Eyenovia Reports Second Quarter 2021 Financial
Announced positive topline data from its Phase
3 VISION-1 study evaluating MicroLine for the treatment of presbyopia
Company on track to initiate second Phase 3
presbyopia trial, VISION-2, by year-end 2021
MydCombi PDUFA date confirmed for October 28,
Company to host conference call and webcast
today, August 11, at 4:30pm ET
YORK-August 11, 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 and operating
results for the second quarter ended June 30, 2021.
Second Quarter 2021 and Recent Business Highlights
Select data highlights include:
Sean Ianchulev, Chief Executive Officer and Chief Medical Officer of Eyenovia, commented, "We are pleased to report another productive
quarter for Eyenovia. The recently announced positive topline data from our Phase 3 VISION-1 trial of MicroLine in presbyopia highlights
the impressive potential of our ophthalmic and Optejet platform. With compelling efficacy and tolerability in patients,
MicroLine, if approved, could become a promising new alternative for patients who desire a temporary, on demand alternative to reading
glasses, particularly in indoor or low light conditions, a clear differentiator versus many other presbyopia therapeutics in development.
We continue to anticipate initiating a second Phase 3 trial, VISION-2, by the end of the year, and anticipate topline data in mid-2022.
"We are actively preparing for our MydCombi
PDUFA date, which has been confirmed for October 28 of this year. We believe MydCombi, our mydriatic candidate, has the potential to become
the new standard of care for the approximately 100 million comprehensive eye exams conducted every year in the U.S. alone.
"The MicroLine and MydCombi programs, together
with MicroPine, which we have out-licensed to Bausch Health and Arctic Vision for up to $100 million in potential development milestones,
compose our late-stage pipeline with three promising candidates and a potential approval as early as October. We look forward to providing
updates on our progress during the remainder of the year," Dr. Ianchulev concluded.
Second Quarter 2021 Financial Review
For the second quarter of 2021, net loss was approximately $4.8
million, or $(0.19) per share, compared to a net loss of approximately $5.0 million, or $(0.25) per share, for
the second quarter of 2020.
For the second quarter of 2021, the Company reported
license fee revenue from its Arctic Vision license agreement of $2.0 million and a corresponding cost of revenue representing payments
to Senju of $800,000.
Research and development expenses for the three
months ended June 30, 2021 totaled $3.6 million, an increase of 24%, as compared to $2.9 million recorded for the three months
ended June 30, 2020.
For the second quarter of 2021, general and administrative
expenses totaled $2.3 million, an increase of 12%, as compared to $2.1 million recorded for the three months ended June 30,
Total operating expenses for the second quarter
of 2021 were approximately $6.0 million, compared to total operating expenses of approximately $5.0 million for the same
period in 2020, an increase of approximately 19%.
As of June 30, 2021, the Company's
cash balance was approximately $27.2 million. This includes $7.5 million of net proceeds received from the previously announced credit
facility of up to $25 million through Silicon Valley Bank (SVB). The remaining two tranches ($7.5 million and $10.0 million in gross proceeds)
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
conference call is scheduled to begin at 4:30pm ET on Wednesday, August 11, 2021. Participants should dial 855-327-6837 (domestic) or
631-891-4304 (international) with the conference code 10015927. 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.
Inc. (NASDAQ: EYEN) is a clinical stage ophthalmic biopharmaceutical company developing a pipeline of microdose array print (MAP)
therapeutics. Eyenovia is currently focused on the late-stage development of microdosed medications for presbyopia, myopia
progression and mydriasis. For more information, visit www.eyenovia.com.
Eyenovia Corporate Information slide deck may be found at ir.eyenovia.com/events-and-presentations.
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 (MydCombi ) 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 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 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 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 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: 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,
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; the potential impacts of COVID-19 and related economic disruptions on our supply chain, including the availability
of sufficient components and materials used in our product candidates; the potential advantages of our product candidates and platform
technology; the rate and degree of market acceptance and clinical utility of our product candidates; our estimates regarding the potential