Full Press Release Details
Eyenovia Reports Fourth Quarter and Full
Year 2018 Financial Results
New York, NY - March 27, 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 fourth quarter
and full year ended December 31, 2018.
Q4 2018 and Recent Business Highlights
Dr. Sean Ianchulev, Eyenovia's Chief
Executive Officer and Chief Medical Officer commented, "Throughout 2018, we worked diligently to advance all of our clinical
programs and further validate the efficacy of our high-precision microdosing platform technology. We were very excited to announce
positive results from our first Phase III program, MicroStat, for pharmacologic mydriasis. The results from the MIST-1 and MIST-2
trials confirmed that our fixed-combination phenylephrine-tropicamide formulation met the
primary efficacy outcome of mean pupil dilation at 35 minutes post administration. We believe that these results not only further
validate our microdose platform technology, but also demonstrate its potential to increase physician efficiency and patient through-put
volume in real world applications. We are now preparing to initiate registration and stability manufacturing lots for MicroStat
and expect to file our NDA in 2020."
"In addition to our success with
MicroStat, the FDA acceptance of our MicroPine IND application represents another milestone achievement that will allow us to initiate
the Phase III registration trial this year. We also expect to initiate another Phase III program with MicroProst this year with
an expanded study population including patients with CACG, OAG and OHT representing what we believe is one of the broadest patient
populations in glaucoma drug development to date."
"I would like to thank our highly
motivated team as well as our shareholders who helped us make 2018 a success. We look forward to continuing to execute on our clinical
initiatives, including the OTC monograph registration of MicroTears this year. We believe that our novel platform technology has
the potential to transform the treatment of front and back-of-the-eye diseases," concluded Dr. Ianchulev.
Fourth Quarter and Full Year 2018 Financial
For the fourth quarter of 2018, net loss
was approximately $6.2 million, or $(0.60) per share, compared to a net loss of approximately $2.2 million, or $(0.84) per share
for the fourth quarter of 2017. For the full year ended December 31, 2018, net loss was approximately $17.3 million, or $(1.82)
per share. This compares to a net loss of approximately $5.1 million, or $(2.19) per share for 2017.
Research and development expenses totaled
approximately $4.1 million for the fourth quarter of 2018, compared to approximately $1.7 million for the same period in 2017,
an increase of 144%. For the full year 2018, research and development expenses increased 191% to approximately $11.1 million compared
to approximately $3.8 million in the prior year.
For the fourth quarter of 2018, general
and administrative expenses were approximately $2.1 million compared with approximately $0.5 million for the fourth quarter of
2017, an increase of 335%. For the full year 2018, general and administrative expenses increased 366% to approximately $6.1 million
versus approximately $1.3 million for the full year of 2017.
Total operating expenses for the fourth
quarter of 2018 were approximately $6.2 million, compared to total operating expenses of approximately $2.2 million for the same
period in 2017, an increase of 186%. For the full year 2018, total operating expenses increased 236% to approximately $17.3 million
compared to $5.1 million for the full year of 2017.
As of December 31, 2018, the Company's
cash balance was approximately $19.7 million.
Conference Call and Webcast
The conference call is scheduled to begin
at 8:30 am ET on Wednesday, March 27, 2019. Participants should dial 1-866-916-2921 (United States) or 1-210-874-7771 (International)
with the conference code 4075747. 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 April
3, 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-tropicamide) 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 help improve efficacy, usability and tolerability of pharmacologic mydriasis.
Feasibility Dose-finding Studies: MicroStat
Ph I/II; MicroStat Ph II
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 (Independent Collaborative Group Trials)
Upcoming Milestone: MicroPine Phase III Trial Start 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
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. The Optejet's targeted delivery
system has demonstrated 85% topical delivery efficacy compared to 40-50% with the conventional eyedropper, and its smart electronics