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
- Reported positive results in the
MicroStat Phase III MIST-1 and MIST-2 registration studies for
mydriasis;
- U.S. Food and Drug Administration
(FDA) accepted investigational new drug (IND) application to
initiate MicroPine Phase III CHAPERONE registration study to reduce
the progression of myopia in children;
- Expanded and streamlined the
MicroProst Phase III program to include chronic angle closure
glaucoma (CACG), as well as open angle glaucoma (OAG) and ocular
hypertension (OHT) patients in a single registration study;
- Published positive results from the
EYN PG21 trial evaluating high-precision microdose latanoprost
demonstrating robust intraocular pressure lowering; and
- Completed underwritten follow-on
public offering of Company common stock with gross proceeds of
approximately $3.4 million, excluding underwriting discounts and
commissions and offering-related expenses.
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 Review
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 code
4075747.
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-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 IIUpcoming 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 (Independent Collaborative Group Trials) Upcoming
Milestone: MicroPine Phase III Trial Start 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 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. The Optejet's targeted delivery system has
demonstrated 85% topical delivery efficacy compared to 40-50% with
the conventional eyedropper, and 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; risks involved in clinical trials, including, but not
limited to, the design, initiation, timing, progress and results of
such trials; the timing and our need and ability to submit
applications for, and obtain and maintain regulatory approvals for,
our product candidates, and to raise money, including in light of
any U.S. government shut-downs; our ability to develop and
implement commercialization, marketing and manufacturing
capabilities and strategies; 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; the impact of government laws and
regulations; 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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Balance Sheets |
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December 31, |
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|
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2018(unaudited) |
|
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2017 |
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Assets |
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Current
Assets: |
|
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|
|
|
Cash |
|
|
$ |
19,728,200 |
|
|
$ |
5,249,511 |
|
|
Prepaid
expenses and other current assets |
|
132,756 |
|
|
|
37,149 |
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|
|
|
|
|
|
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Total
Current Assets |
|
19,860,956 |
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|
|
5,286,660 |
|
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|
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|
|
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Property
and equipment, net |
|
36,738 |
|
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|
27,960 |
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Deferred
offering costs |
|
- |
|
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|
328,700 |
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Security
deposit |
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|
117,800 |
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- |
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Total
Assets |
$ |
20,015,494 |
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$ |
5,643,320 |
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Liabilities and Stockholders' Equity |
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Current
Liabilities: |
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Accounts
payable |
$ |
1,509,524 |
|
|
$ |
246,384 |
|
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Accrued
compensation |
|
923,981 |
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|
|
- |
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|
Accrued
expenses and other current liabilities |
|
665,336 |
|
|
|
306,263 |
|
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|
|
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|
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Total
Current Liabilities |
|
3,098,841 |
|
|
|
552,647 |
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Deferred
rent |
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41,584 |
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- |
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Total
Liabilities |
|
3,140,425 |
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|
552,647 |
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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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Series A Convertible Preferred Stock, 0 and 20,000,000 shares
designated |
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as of December 31, 2018 and 2017, respectively, |
|
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|
0 and 2,932,431 shares issued and outstanding |
|
|
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|
as of December 31, 2018 and 2017, respectively |
|
- |
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|
293 |
|
|
Series A-2 Convertible Preferred Stock, 0 and 5,714,286 shares
designated |
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as of December 31, 2018 and 2017, respectively, |
|
|
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0 and 788,827 shares issued and outstanding |
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|
|
|
as of December 31, 2018 and 2017, respectively |
|
- |
|
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|
79 |
|
|
Series B Convertible Preferred Stock, 0 and 10,000,000 shares
designated |
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as of December 31, 2018 and 2017, respectively, |
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0 and 918,983 shares issued and outstanding |
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|
as of December 31, 2018 and 2017, respectively |
|
- |
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|
92 |
|
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Common
stock, $0.0001 par value, 90,000,000 shares authorized; |
|
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11,468,996 and 2,566,530 shares issued and outstanding |
|
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|
as of December 31, 2018 and 2017, respectively |
|
1,147 |
|
|
|
257 |
|
|
Additional
paid-in capital |
|
53,388,216 |
|
|
|
24,351,138 |
|
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Accumulated
deficit |
|
(36,514,294 |
) |
|
|
(19,261,186 |
) |
|
|
|
|
|
|
|
|
|
Total
Stockholders' Equity |
|
16,875,069 |
|
|
|
5,090,673 |
|
|
|
|
|
|
|
|
|
|
Total
Liabilities and Stockholders' Equity |
$ |
20,015,494 |
|
|
$ |
5,643,320 |
|
EYENOVIA, INC. |
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Statements of Operations |
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For the Three Months Ended |
|
For the Years Ended |
|
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|
December 31, |
|
December 31, |
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2018 |
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2017 |
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2018 |
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2017 |
|
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(unaudited) |
|
(unaudited) |
|
(unaudited) |
|
|
Operating Expenses: |
|
|
|
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|
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Research
and development |
$ |
4,125,264 |
|
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$ |
1,690,739 |
|
|
$ |
11,119,096 |
|
|
$ |
3,816,732 |
|
|
General and
administrative |
|
2,058,098 |
|
|
|
472,676 |
|
|
|
6,137,347 |
|
|
|
1,315,635 |
|
|
|
|
|
|
|
|
|
|
|
|
|
Total Operating
Expenses |
|
6,183,362 |
|
|
|
2,163,415 |
|
|
|
17,256,443 |
|
|
|
5,132,367 |
|
|
|
|
|
|
|
|
|
|
|
|
|
Loss From
Operations |
|
(6,183,362 |
) |
|
|
(2,163,415 |
) |
|
|
(17,256,443 |
) |
|
|
(5,132,367 |
) |
|
|
|
|
|
|
|
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|
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Other Income: |
|
|
|
|
|
|
|
|
Interest
income |
|
255 |
|
|
|
984 |
|
|
|
3,335 |
|
|
|
2,380 |
|
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|
|
|
|
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|
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Net
Loss |
$ |
(6,183,107 |
) |
|
$ |
(2,162,431 |
) |
|
$ |
(17,253,108 |
) |
|
$ |
(5,129,987 |
) |
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Net Loss Per Share |
|
|
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|
|
|
|
|
- Basic
and Diluted |
$ |
(0.60 |
) |
|
$ |
(0.84 |
) |
|
$ |
(1.82 |
) |
|
$ |
(2.19 |
) |
|
|
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|
|
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|
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Weighted Average Number
of |
|
|
|
|
|
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|
|
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Common
Shares Outstanding |
|
|
|
|
|
|
|
|
|
- Basic
and Diluted |
|
10,240,644 |
|
|
|
2,566,530 |
|
|
|
9,476,706 |
|
|
|
2,344,712 |
|
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