Full Press Release Details
Eyenovia Reports First Quarter 2020 Financial
New York, NY - May 13, 2020 -
Eyenovia, Inc. (NASDAQ: EYEN), a clinical stage ophthalmic biopharmaceutical company developing a pipeline of microdose therapeutics
utilizing its patented piezo-print delivery technology, today announced its financial results for the first quarter ended March
First Quarter 2020 and Recent Business
"In the first quarter of 2020, we
successfully strengthened our balance sheet with our private placement, which should fund the Company's operations into 2021.
Looking ahead, we are preparing to submit our New Drug Application for MicroStat to the FDA this year, as well as anticipate initiating
our Phase III trials for MicroLine when the environment becomes safe to do so. We also look forward to re-initiating enrollment
of our MicroPine Phase III trial, and in the interim, will continue to supply cartridges of MicroPine by mail and work with our
clinical partners to follow-up virtually with previously enrolled study participants," commented Dr. Sean Ianchulev, Eyenovia's
Chief Executive Officer and Chief Medical Officer. "Our priority remains the health
and safety of our employees, patients, and partners as well as the communities they serve. We believe that our fearless
Eyenovia spirit of ingenuity and resilience will help ensure that we persevere through this period of uncertainty."
First Quarter 2020 Financial Review
For the first quarter of 2020, net loss
was approximately $5.5 million, or $(0.31) per share, compared to a net loss of approximately $5.9 million, or $(0.50) per share
for the first quarter of 2019.
Research and development expenses totaled
approximately $3.6 million for the first quarter of 2020, compared to approximately $4.0 million for the same period in 2019, a
decrease of approximately 9.3%.
For the first quarter of 2020, general
and administrative expenses were approximately $1.8 million compared to approximately $1.9 million for the first quarter of 2019,
a decrease of approximately 5.5%.
Total operating expenses for the first
quarter of 2020 were approximately $5.5 million, compared to total operating expenses of approximately $6.0 million for the same
period in 2019, a decrease of approximately 8.1%.
As of March 31, 2020, the Company's
cash balance was approximately $13.7 million. This includes approximately $5.4 million of net proceeds from Eyenovia's private
placement, which closed in March 2020.
Conference Call and Webcast
The conference call is scheduled to begin
at 4:45pm ET on Wednesday, May 13, 2020. Participants should dial 1-866-916-2921 (United States) or 1-210-874-7771 (International)
with the conference code 4397339. 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 May
20, 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 therapeutics utilizing its patented piezo-print
delivery technology. 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 Eyenovia's 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 first-in-class topical treatment 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) 391:399).
Feasibility Dose-finding Atropine Studies:
ATOM 1; ATOM 2; LAMP (Independent Collaborative
About MicroStat for Mydriasis
MicroStat is Eyenovia's first-in-class
fixed-combination micro-formulation product (phenylephrine 2.5% -tropicamide 1%) 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
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
in the United States 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; the potential impacts of COVID-19 on our supply chain; risks
of our clinical trials, including, but not limited to, the costs, design, initiation and enrollment (which could continue to 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 success
of our reprioritized pipeline; any cost savings related to our reprioritized pipeline; 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; our ability to timely develop and implement anticipated manufacturing, commercialization
and marketing capabilities and strategies for existing product candidates; 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