Full Press Release Details
Eyenovia Reports First Quarter 2019 Financial
New York, NY - May 14, 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 first quarter ended March
Q1 2019 and Recent Business Highlights
"We kicked-off 2019 with a number
of successes that further validate our novel approach in ophthalmology that we believe will help us advance multiple programs towards
Phase III initiations this year," commented Dr. Sean Ianchulev, Eyenovia's Chief Executive Officer and Chief Medical
Officer. "The positive MicroStat Phase III results which we presented at the ASCRS annual meeting confirmed that we can deliver
drugs to the eye with high precision and efficacy using our microdosing technology. These results also help validate our delivery
platform as we work diligently towards the initiation of our MicroPine and MicroProst Phase III programs, in which we expect to
begin enrolling patients towards the middle and end of 2019, respectively. We are committed to advancing our clinical initiatives,
including the preparation of the necessary registration and stability manufacturing materials for the submission of our first New
Drug Application for MicroStat in 2020. We look forward to making 2019 another successful year as we seek to transform the treatment
paradigm of front and back-of-the-eye diseases."
First Quarter 2019 Financial Review
For the first quarter of 2019, net loss
was approximately $5.9 million, or $(0.50) per share, compared to a net loss of approximately $3.4 million, or $(0.45) per share
for the first quarter of 2018.
Research and development expenses totaled
approximately $4.0 million for the first quarter of 2019, compared to approximately $2.1 million for the same period in 2018, an
increase of approximately 91%.
For the first quarter of 2019, general
and administrative expenses were approximately $1.9 million compared to approximately $1.3 million for the first quarter of 2018,
an increase of approximately 45%.
Total operating expenses for the first
quarter of 2019 were approximately $6.0 million, compared to total operating expenses of approximately $3.4 million for the same
period in 2018, an increase of approximately 73%.
As of March 31, 2019, the Company's
cash and cash equivalents balance was approximately $14.3 million.
Conference Call and Webcast
The conference call is scheduled to begin
at 8:30 am ET on Tuesday, May 14, 2019. Participants should dial 1-866-916-2921 (United States) or 1-210-874-7771 (International)
with the conference code 1468679. 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
21, 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
mydriasis, myopia progression, glaucoma, and other eye diseases. For more Information please visit www.eyenovia.com.
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 address the growing needs 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.
We are developing MicroStat to improve the efficacy and tolerability of pharmacologic mydriasis.
Upcoming Milestone: NDA Filing 2020
About MicroPine for Progressive Myopia
MicroPine is Eyenovia's first-in-class
topical treatment for progressive myopia, a back-of-the-eye disease. Progressive myopia is estimated to affect close to 5 million
patients 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.
Early dose finding studies by collaborative academic groups have demonstrated high therapeutic potential with low dose atropine
which can reduce myopia progression by 60 - 70% with a sustained effect through three years. 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 Group Trials)
Upcoming Milestone: MicroPine Phase III Trial Start Mid-2019
About MicroProst for Glaucoma and Ocular
MicroProst is Eyenovia's proprietary latanoprost
formulation product candidate, which is being developed as a first-line treatment for the reduction of IOP in patients with Chronic
Angle Closure Glaucoma (CACG), as well as Primary Open Angle Glaucoma (POAG) and Ocular Hypertension. Currently, there are no FDA-approved
therapies specifically indicated for CACG, which accounts for an estimated 10% and 50% of all glaucoma diagnoses in the United
States and China, respectively. We believe there are approximately 500,000 patients with CACG in the United States and approximately
3.0 million with POAG for whom chronic, often life-long medication therapy is required.
Feasibility Dose-Finding Studies: MicroProst Phase II EYN PG21
Upcoming Milestone: MicroProst Phase III
Trial Start End of 2019
About MicroTears OTC for Hyperemia,
Pruritis and Dry Eye
MicroTears is a micro-droplet ocular hyperemia
(red eye), pruritis (itch) and ocular lubrication product candidate for the approximately $850 million annual OTC artificial tear
market in the United States.
Upcoming Milestone: OTC Monograph Registration
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 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. 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; our ability
to raise money; risks involved in clinical trials, including, but not limited to, the design, initiation, timing, progress and
results of such trials; the timing and our ability to submit applications for, and obtain and maintain regulatory approvals for,
our product candidates; our ability to develop and implement commercialization, marketing and manufacturing capabilities and strategies
for existing product candidates and our ability to identify new product candidates; the potential advantages of our product candidates;