Full Press Release Details
Eyenovia Reports Second Quarter 2020
New York, NY - August 12, 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 second quarter ended June 30, 2020.
Second Quarter 2020 and Recent Business
"Earlier this week, we entered
into a license agreement with Arctic Vision, a China-based ophthalmology company, to develop and commercialize MicroPine and
MicroLine for the Greater China (mainland China, Hong Kong, Macau and Taiwan) and South Korean markets. This transaction,
which includes payments of up to $45.75 million in potential license and product development fees as well as commercial
supply terms or royalties, expands the commercial reach of our programs into markets where the number of myopic children is
estimated at greater than 240 million, more than eight times that of the United States," commented Dr. Sean Ianchulev,
Eyenovia's Chief Executive Officer and Chief Medical Officer. "In the coming months and subject to any impacts of
COVID-19, we also look forward to initiating our Phase III VISION trials for MicroLine and plan to submit our New Drug
Application for MicroStat to the FDA by the end of the year."
Second Quarter 2020 Financial Review
For the second quarter of 2020, net loss
was approximately $5.0 million, or $(0.25) per share, compared to a net loss of approximately $5.3 million, or $(0.44) per share
for the second quarter of 2019.
Research and development expenses totaled
approximately $2.9 million for the second quarter of 2020, compared to approximately $3.6 million for the same period in 2019,
a decrease of approximately 18.3%.
For the second quarter of 2020, general
and administrative expenses were approximately $2.1 million compared to approximately $1.8 million for the second quarter of 2019,
an increase of approximately 16.3%.
Total operating expenses for the
second quarter of 2020 were approximately $5.0 million, compared to total operating expenses of approximately $5.4 million
for the same period in 2019, a decrease of approximately 6.7%. Operating expenses for the second quarter of 2020 include
approximately $0.6 million of non-cash stock compensation expense.
As of June 30, 2020, the Company's
cash balance was approximately $10.2 million.
Conference Call and Webcast
The conference call is scheduled to begin
at 4:30pm ET on Wednesday, August 12, 2020. Participants should dial 1-866-916-2921 (United States) or 1-210-874-7771 (International)
with the conference code 7380187. 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. In addition, a telephonic replay of the call will be available until August
19, 2020. The replay can be accessed by dialing 1-855-859-2056 (United States) or 1-404-537-3406 (International) with confirmation
Eyenovia, Inc. (NASDAQ: EYEN) is a clinical
stage ophthalmic biopharmaceutical company developing a pipeline of microdose array print (MAPTM) 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 MicroPine for Progressive Myopia
MicroPine (atropine ophthalmic
solution) is for progressive myopia, a back-of-the-eye condition commonly known as nearsightedness. Progressive myopia is
estimated to affect close to 5 million children in the United States who suffer from uncontrolled axial elongation of the
sclera leading to increasing levels of myopia and in some cases major pathologic changes such as retinal atrophy, macular
staphylomas, retinal detachment and visual impairment. MicroPine has been developed for comfort and ease-of-use in children.
Microdose administration of MicroPine is anticipated to result in low systemic and ocular drug exposure. A recent therapeutic
evidence assessment and review by the American Academy of Ophthalmology indicates Level 1 (highest) evidence of efficacy for
the role of low dose atropine for progressive myopia (Ophthalmology 2017;124:1857-1866; Ophthalmology 2016; 123(2)
Feasibility Dose-finding Atropine Studies:
ATOM 1; ATOM 2; LAMP (Independent Collaborative Group Trials)
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 MicroStat for Mydriasis
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
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. 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 SEC. In addition, such statements could be affected by risks and uncertainties related to, among other things:
impacts of and uncertainty related to COVID-19; fluctuations in our financial results, particularly given market conditions and
the potential economic impact of COVID-19; our need to raise additional money to fund our operations for at least the next 12 months
as a going concern; our ability 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 potential impacts of COVID-19 on our supply chain; the timing and our ability to submit applications for, obtain
and maintain regulatory approvals for our product candidates; our estimates regarding the potential market opportunity for our
product candidates; the potential advantages of our product candidates; the rate and degree of market acceptance and clinical utility
of our product candidates; the potential success of our reprioritized pipeline; any cost savings related to our reprioritized pipeline;
our ability to attract and retain key personnel; intellectual property risks; 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 forward-looking statements speak only as of the date on which they are made, and except as may
be required under applicable securities laws, we do not undertake any obligation to update any forward-looking statements.
Chief Financial Officer