Full Press Release Details
Eyenovia Reports Third Quarter 2019 Financial
New York, NY - November 13, 2019
- 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 third quarter
ended September 30, 2019.
Third Quarter 2019 and Recent Business
"We have been very pleased with our
clinical progress this year as we continue to build a robust late-stage pipeline in ophthalmology using our next generation, intelligent
microdosing platform. The completion of our MicroStat Phase III studies for pharmacologic mydriasis as well as the initiation of
our Phase III study for our MicroPine program for the treatment of progressive myopia earlier this year, have helped demonstrate
the potential of our novel therapies," commented Dr. Sean Ianchulev, Eyenovia's Chief Executive Officer and Chief Medical
Officer. "As we work to maximize the value of our internal portfolio, we recently conducted a comprehensive strategic review
of all our programs. As a result, we decided to reprioritize our efforts to focus on MicroPine, MicroStat, and MicroLine for improving
near vision in patients with presbyopia. We believe that these programs represent areas where there are currently no known drugs
approved or where we can greatly improve the patient experience. As we approach year end, we are particularly focused on advancing
our MicroLine program towards Phase III development and expect to initiate and complete the Phase III VISION studies in 2020."
"With the additional support of our
successful capital raise this summer and the anticipated cost savings from our pipeline reprioritization, we remain well positioned
to fund our programs. We appreciate the continued support of our shareholders and look forward to providing additional updates
on our clinical progress," concluded Dr. Ianchulev.
Third Quarter 2019 Financial Review
For the third quarter of 2019, net loss
was approximately $4.6 million, or $(0.29) per share, compared to a net loss of approximately $4.3 million, or $(0.43) per share
for the third quarter of 2018.
Research and development expenses totaled
approximately $3.2 million for the third quarter of 2019, compared to approximately $2.5 million for the same period in 2018, an
increase of approximately 29%. The increase was primarily attributable to an increase in contracted services, expanded research
and development activities and an increase in facilities and other expenses related to supplies and materials.
For the third quarter of 2019, general
and administrative expenses were approximately $1.5 million compared to approximately $1.8 million for the third quarter of 2018,
a decrease of approximately 19%. This decrease was primarily attributable to a decrease in legal and professional fees of $0.4
million due to higher expenses in 2018 related to activities performed to assess various financing opportunities.
Total operating expenses for the third
quarter of 2019 were approximately $4.7 million, compared to total operating expenses of approximately $4.3 million for the same
period in 2018, an increase of approximately 9%.
As of September 30, 2019, the Company's
cash and cash equivalents balance was approximately $18.3 million.
Conference Call and Webcast
The conference call is scheduled to begin
at 5:00 pm ET on Wednesday, November 13, 2019. Participants should dial 1-866-916-2921 (United States) or 1-210-874-7771 (International)
with the conference code 6128678. 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 November
20, 2019. 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 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 high
precision microdosing technology combined with pilocarpine could provide a meaningful improvement in near-vision while enhancing
tolerability and usability.
Upcoming Milestone: Initiate and Complete
MicroLine Phase III Trial in 2020
About MicroPine for Progressive Myopia
MicroPine 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 people 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 is designed for comfort and ease-of-use in children, with low systemic and
ocular drug exposure due to microdosing. 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
Upcoming Milestone: Complete Enrollment
of the Phase III CHAPERONE Study in 2020
About MicroStat for Mydriasis
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. Designed for use without an anesthetic, we are developing MicroStat to improve the efficacy and tolerability
of pharmacologic mydriasis.
Upcoming Milestone: File NDA in 2020
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 with minimal training in 85% of topical medication administrations 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
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: fluctuations in our financial results; the potential success of our reprioritized
pipeline; any cost savings related to our reprioritized pipeline; our ability to identify new product candidates; the rate and