Full Press Release Details
Eyenovia Reports Third Quarter 2020 Financial
Company to host conference call and webcast
today, November 10, at 4:30pm ET
New York, NY, Nov. 10, 2020 -
Eyenovia, Inc., (NASDAQ: EYEN), a clinical stage ophthalmic biopharmaceutical company developing a pipeline of microdose array
print (MAP ) therapeutics, today reported its financial results for the third quarter ended September 30, 2020.
"During the third quarter and subsequent
period, we continued to execute on our growth strategy to advance our late-stage ophthalmic portfolio while in parallel securing
global development and commercialization partnerships to further extend the reach of our proprietary Optejet microdosing technology,"
commented Dr. Sean Ianchulev, Eyenovia's Chief Executive Officer and Chief Medical Officer. "We announced important
licensing agreements with both Bausch Health and Arctic Vision. We believe these companies can help introduce MicroPine and MicroLine
to some of the biggest eyecare markets in the world, while at the same time providing us with non-dilutive capital to advance our
corporate initiatives."
"We remain on track to file an
NDA for Mydcombi , our intended brand name for MicroStat, for pharmacologic mydriasis by the end of this year and to
initiate our Phase 3 presbyopia program imminently, subject to any impacts of COVID-19. Presbyopia is one of the leading
therapeutic opportunities in ophthalmology, estimated to affect more than 100 million people in the U.S. alone. And while
there are other companies working on new treatments for presbyopia, we believe Eyenovia could be among the first to deliver
Phase 3 results, potentially in the first quarter of 2021. With a current cash position of approximately $31 million, which
includes a $10 million upfront payment from Bausch Health last month, we believe we are well funded to pursue these important
milestones," Dr. Ianchulev concluded.
Third Quarter 2020 and Recent Business
Third Quarter 2020 Financial Review
For the third quarter of 2020, net loss
was approximately $5.1 million, or $(0.23) per share, compared to a net loss of approximately $4.6 million,
or $(0.29) per share for the third quarter of 2019.
Research and development expenses totaled
approximately $3.4 million for the third quarter of 2020, compared to approximately $3.2 million for the same
period in 2019, an increase of approximately 5.1%.
For the third quarter of 2020, general
and administrative expenses were approximately $1.7 million compared to approximately $1.5 million for the
third quarter of 2019, an increase of approximately 16.0%.
Total operating expenses for the third
quarter of 2020 were approximately $5.1 million, compared to total operating expenses of approximately $4.7 million for
the same period in 2019, an increase of approximately 8.6%.
As of September 30, 2020, the Company's
cash balance was approximately $22.9 million.
Conference Call and Webcast
The conference call is scheduled to begin
at 4:30pm ET today, November 10, 2020. Participants should dial 877-407-9039 (domestic) or 201-689-8470 (international)
with the conference code 13713084. 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 the Company's website for one year.
About Eyenovia, Inc.
Eyenovia, Inc. (NASDAQ: EYEN) is a clinical
stage ophthalmic biopharmaceutical company developing a pipeline of microdose array print (MAP) therapeutics. Eyenovia's
pipeline is currently focused on the late-stage development of microdosed medications for presbyopia, myopia progression and mydriasis.
For more Information, please 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.
About 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 80 million office-based comprehensive and diabetic 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, we are developing MicroStat to improve the efficacy and tolerability of pharmacologic mydriasis.
About Optejet and MicroRx Ocular
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 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 any potential revenue from licensing transactions.
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 and uncertainties arising
from the recent U.S. elections; our estimates regarding the potential market opportunity for our product candidates and
potential revenue from licensing transactions; reliance on third parties to develop and commercialize our product candidates;
the ability of us and our partners to timely develop, implement and maintain manufacturing, commercialization and marketing
capabilities and strategies for our product candidates; 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 and our ability to submit applications for, obtain and
maintain regulatory approvals for our product candidates; the potential impacts of COVID-19 on our supply chain; the
potential advantages of our product candidates; the rate and degree of market
acceptance and clinical utility of our product candidates; our ability to raise additional capital; intellectual property risks; our ability to attract and retain key
personnel; changes in legal, regulatory and legislative environments in the markets in which we operate and the impact of
these changes on our ability to obtain regulatory approval for our products; and our competitive position. Any