Full Press Release Details
Eyenovia Reports Second Quarter 2019
New York, NY - August 12, 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 second quarter
ended June 30, 2019.
Second Quarter 2019 and Recent Business
"We are very pleased with the progress
we made last quarter as we steadily advance our late stage clinical pipeline and continue to validate our platform technology to
change the treatment paradigm of front and back-of-the-eye diseases. We recently initiated our Phase III CHAPERONE study for progressive
myopia in children. Progressive myopia represents an estimated $5 billion U.S. market opportunity for Eyenovia and has the potential
to be the first topical therapeutic to treat myopia progression. In addition, we expect the MILAGRO trial for MicroProst for the
lowering of intraocular pressure in glaucoma to begin enrollment by the end of this year. MILAGRO will be our third product candidate
to enter Phase III development over the last nine months," commented Dr. Sean Ianchulev, Eyenovia's Chief Executive
Officer and Chief Medical Officer. "With our recent successful capital raise, we believe Eyenovia is well positioned to continue
advancing both the MicroPine and MicroProst trials and we intend to move our MicroStat program towards an NDA submission in 2020.
We look forward to executing on our milestones through the remainder of the year and would like to thank our shareholders for their
Second Quarter 2019 Financial Review
For the second quarter of 2019, net loss
was approximately $5.3 million, or $(0.44) per share, compared to a net loss of approximately $3.3 million, or $(0.33) per share
for the second quarter of 2018.
Research and development expenses totaled
approximately $3.6 million for the second quarter of 2019, compared to approximately $2.4 million for the same period in 2018,
an increase of approximately 48%, due to the continuing advancement of the Company's clinical drug pipeline.
For the second quarter of 2019, general
and administrative expenses were approximately $1.8 million compared to approximately $0.9 million for the second quarter of 2018,
an increase of approximately 99%.
Total operating expenses for the second
quarter of 2019 were approximately $5.4 million, compared to total operating expenses of approximately $3.3 million for the same
period in 2018, an increase of approximately 62%.
As of June 30, 2019, the Company's
cash and cash equivalents balance was approximately $9.2 million. This amount does not include the approximately $13.0 million
in aggregate net proceeds from Eyenovia's underwritten public offering which closed in July 2019.
Conference Call and Webcast
The conference call is scheduled to begin
at 4:30 pm ET on Monday, August 12, 2019. Participants should dial 1-866-916-2921 (United States) or 1-210-874-7771 (International)
with the conference code 6217226. 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, 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
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
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.
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)
Feasibility Dose-finding Atropine Studies:
ATOM 1; ATOM 2; LAMP (Independent Collaborative
Upcoming Milestone: Complete Enrollment of the Phase III CHAPERONE Study End of 2020
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: Commercial Launch to
Coincide with Potential MicroStat Commercialization
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. 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; 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