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 31, 2019.
Q1 2019 and Recent Business
Highlights
- Presented positive results from the MicroStat Phase III MIST-1
and MIST-2 registration studies for pharmacologic mydriasis at the
joint American Society of Cataract and Refractive Surgery (ASCRS)
and American Society of Ophthalmic Administrators (ASOA) annual
meeting;
- Received U.S Food and Drug Administration (FDA) acceptance of
our investigational new drug (IND) application to initiate the
MicroPine Phase III CHAPERONE registration study aimed at reducing
the progression of myopia in children; and
- Expanded the MicroProst Phase III program to include chronic
angle closure glaucoma (CACG), open angle glaucoma (OAG), and
ocular hypertension (OHT) patients in a single registration
study.
“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 code
1468679.
About EyenoviaEyenovia, 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
MydriasisMicroStat 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
MyopiaMicroPine 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
HypertensionMicroProst 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 PG21Upcoming Milestone: MicroProst
Phase III Trial Start End of 2019
About MicroTears OTC for Hyperemia,
Pruritis and Dry EyeMicroTears 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
2019
About Optejet™ and MicroRx Ocular
TherapeuticsEyenovia's Optejet microdose formulation and
delivery platform for ocular therapeutics uses high-precision
piezo-print technology to deliver 6-8 μL 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
StatementsExcept 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; the rate and degree
of market acceptance and clinical utility of our product
candidates; our estimates regarding the potential market
opportunity for our product candidates; 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 do not undertake any
obligation to update any forward-looking statements.
Caution: New Drug―Limited by Federal (United
States) law to investigational use.
Company Contact:Eyenovia,
Inc.John GandolfoChief Financial
Officerjgandolfo@eyenoviabio.com
Investor Contact:Tram Bui /
Alexander LoboThe Ruth Group646-536-7035/7037tbui@theruthgroup.com
/ alobo@theruthgroup.com
Media Contact:The Ruth
GroupKirsten Thomas508-280-6592kthomas@theruthgroup.com
(Financial Statements to Follow)
EYENOVIA, INC. |
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Condensed Balance Sheets |
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March 31, |
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December 31, |
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2019 |
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2018 |
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(unaudited) |
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Assets |
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Current
Assets: |
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|
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Cash and cash
equivalents |
$ |
14,315,348 |
|
|
$ |
19,728,200 |
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Prepaid expenses
and other current assets |
|
560,329 |
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|
132,756 |
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|
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|
|
|
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Total Current
Assets |
|
14,875,677 |
|
|
|
19,860,956 |
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|
|
|
|
|
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Property and
equipment, net |
|
34,185 |
|
|
|
36,738 |
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Security
deposit |
|
|
117,800 |
|
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|
117,800 |
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Total Assets |
$ |
15,027,662 |
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$ |
20,015,494 |
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Liabilities and Stockholders' Equity |
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Current
Liabilities: |
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Accounts
payable |
$ |
2,061,043 |
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$ |
1,509,524 |
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Accrued
compensation |
|
417,061 |
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|
912,104 |
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Accrued expenses
and other current liabilities |
|
46,825 |
|
|
|
677,213 |
|
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|
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|
|
|
|
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Total Current
Liabilities |
|
2,524,929 |
|
|
|
3,098,841 |
|
|
|
|
|
|
|
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Deferred rent |
|
43,200 |
|
|
|
41,584 |
|
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|
|
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Total
Liabilities |
|
2,568,129 |
|
|
|
3,140,425 |
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Commitments and
contingencies |
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Stockholders'
Equity: |
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Preferred stock,
$0.0001 par value, 6,000,000 shares authorized; |
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0 shares issued and outstanding as of March 31, 2019 and |
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as of December 31, 2018 |
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- |
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- |
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Common stock,
$0.0001 par value, 90,000,000 shares authorized; |
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12,019,148 and 11,468,996 shares issued and outstanding |
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as of March 31, 2019 and December 31, 2018, respectively |
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1,202 |
|
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1,147 |
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Additional paid-in
capital |
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54,905,009 |
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53,388,216 |
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Accumulated
deficit |
|
(42,446,678 |
) |
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(36,514,294 |
) |
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Total
Stockholders' Equity |
|
12,459,533 |
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16,875,069 |
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Total Liabilities
and Stockholders' Equity |
$ |
15,027,662 |
|
|
$ |
20,015,494 |
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EYENOVIA, INC. |
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Condensed Statements of Operations |
(unaudited) |
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For the Three Months Ended |
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|
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March 31, |
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2019 |
|
2018 |
|
|
|
|
|
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Operating
Expenses: |
|
|
|
|
Research and
development |
$ |
4,008,896 |
|
|
$ |
2,094,095 |
|
|
General and
administrative |
|
1,942,763 |
|
|
|
1,337,649 |
|
|
|
|
|
|
|
|
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Total Operating Expenses |
|
5,951,659 |
|
|
|
3,431,744 |
|
|
|
|
|
|
|
|
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Loss From Operations |
|
(5,951,659 |
) |
|
|
(3,431,744 |
) |
|
|
|
|
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Other
Income: |
|
|
|
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Interest
income |
|
19,275 |
|
|
|
2,137 |
|
|
|
|
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|
|
|
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Net Loss |
$ |
(5,932,384 |
) |
|
$ |
(3,429,607 |
) |
|
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Net Loss Per Share |
|
|
|
|
|
- Basic and Diluted |
$ |
(0.50 |
) |
|
$ |
(0.45 |
) |
|
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|
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Weighted Average Number
of |
|
|
|
|
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Common Shares Outstanding |
|
|
|
|
|
- Basic and Diluted |
|
11,919,973 |
|
|
|
7,561,915 |
|
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