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, 2019.
Fourth Quarter 2019 and Recent Business
Highlights
- Advanced MicroLine for the improvement in near vision in
patients with presbyopia towards Phase III development;
- Deferred development activities for the MicroProst (glaucoma
and ocular hypertension) and MicroTears (red eye and itch
relief/lubrication) programs;
- Expanded Scientific Advisory Board with the addition of Mark
Bullimore, PhD and April Jasper, OD; and
- Successfully completed a private placement of units comprised
of common stock and warrants with aggregate net proceeds to the
Company of approximately $5.3 million in March 2020.
“2019 was a very successful year for Eyenovia,
as we made significant advancements in our late stage ophthalmology
pipeline that continued to validate our high precision microdosing
platform,” commented Dr. Sean Ianchulev, Eyenovia’s Chief Executive
Officer and Chief Medical Officer. “We completed our MicroStat
Phase III MIST-1 and MIST-2 studies for pharmacologic mydriasis,
which support our novel approach to treating front and back of the
eye conditions. These results also paved the way for the initiation
of our MicroPine Phase III CHAPERONE study for progressive myopia,
which is currently enrolling subjects. In 2019, we also
reprioritized our pipeline to focus on our highest value
opportunities and introduced our Phase III ready MicroLine program
for presbyopia. We believe that we could transform the primarily
device-based treatment paradigm for an estimated 43 million people
in the United States with a cash-pay prescription therapy with our
proprietary microdose formulation of pilocarpine. With a bolstered
balance sheet, we have anticipated milestones in our Phase
III programs for presbyopia and myopia, as well as the planned
MicroStat NDA this year, although we are closely monitoring the
evolving situation of the COVID-19 pandemic and its potential
impact on our business.”
Fourth Quarter and Full Year 2019
Financial Review
For the fourth quarter of 2019, net loss was
approximately $5.2 million, or $(0.31) per share, compared to a net
loss of approximately $6.2 million, or $(0.60) per share for the
fourth quarter of 2018. For the full year ended December 31, 2019,
net loss was approximately $21.2 million, or $(1.47) per share.
This compares to a net loss of approximately $17.3 million, or
$(1.82) per share for the full year of 2018.
Research and development expenses totaled
approximately $3.3 million for the fourth quarter of 2019, compared
to approximately $4.1 million for the same period in 2018, a
decrease of 19.4%. For the full year 2019, research and development
expenses increased 26.8% to approximately $14.1 million compared to
approximately $11.1 million in the prior year.
For the fourth quarter of 2019, general and
administrative expenses were approximately $2.0 million compared to
approximately $2.1 million for the fourth quarter of 2018, a
decrease of 4.5%. For the full year 2019, general and
administrative expenses increased 17.4% to approximately $7.2
million versus approximately $6.1 million for the full year of 2018
due largely to an increase in non-cash stock compensation expense
of approximately $0.9 million.
Total operating expenses for the fourth quarter
of 2019 were approximately $5.3 million, compared to total
operating expenses of approximately $6.2 million for the same
period in 2018, a decrease of 14.5%. Operating expenses for the
fourth quarter of 2019 include approximately $0.6 million of
non-cash stock compensation expense. For the full year 2019, total
operating expenses increased 23.5% to approximately $21.3 million
compared to $17.3 million for the full year of 2018. 2019 operating
expenses include approximately $2.5 million of non-cash stock
compensation expenses.
As of December 31, 2019, the Company’s cash and
cash equivalents was approximately $14.2 million. This excludes
approximately $5.3 million of net proceeds from Eyenovia’s private
placement which closed on March 24, 2020.
Conference Call and Webcast
The conference call is scheduled to begin at
4:30 pm ET on Wednesday, March 25, 2020. Participants should dial
1-866-916-2921 (United States) or 1-210-874-7771 (International)
with the conference code 7487792. 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 1,
2020. The replay can be accessed by dialing 1-855-859-2056 (United
States) or 1-404-537-3406 (International) with confirmation code
7487792.
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 presbyopia, myopia progression and mydriasis. For
more Information please visit www.eyenovia.com.
About MicroLine for
PresbyopiaMicroLine is Eyenovia’s pharmacologic treatment
for presbyopia. Presbyopia is the non-preventable, age related
hardening of the lens, which causes a gradual loss of the eye’s
ability to focus on nearby objects and is estimated to affect
nearly 113 million Americans. Current treatment options are
typically device-based, such as reading glasses and contact lenses.
Pilocarpine ophthalmic solution is known to constrict the pupil and
improve near-distance vision by creating an extended depth of focus
through its small aperture effect. Eyenovia believes that its
administration of pilocarpine using the company’s high precision
microdosing technology could provide a meaningful improvement in
near vision while enhancing tolerability and usability.
Anticipated Milestone: Initiate and Complete
Phase III VISION Trials in 2020
About MicroPine for Progressive
MyopiaMicroPine (atropine ophthalmic solution) is
Eyenovia's first-in-class topical treatment for progressive myopia,
a back-of-the-eye condition commonly known as nearsightedness.
Progressive myopia is estimated to affect close to 5 million
children 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.
MicroPine has been developed for comfort and ease-of-use in
children. Microdose administration of MicroPine is
anticipated to result in low systemic and ocular drug exposure.
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)
Anticipated Milestone: Complete Enrollment of
the Phase III CHAPERONE Study in 2020
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 improve the efficiency 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. Developed for use without anesthetic, we are
developing MicroStat to improve the efficacy and tolerability of
pharmacologic mydriasis.
Anticipated Milestone: File NDA in 2020
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
more than 85% of the time after basic training in a variety of
clinical settings 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, including estimated market opportunities in
the United States for our product candidates. 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 and stock price, particularly given market conditions and
the potential economic impact of COVID-19; our need to raise
additional money to fund our operations for at least the next 12
months as a going concern; the potential impacts of the coronavirus
pandemic on our supply chain; risks of our clinical trials,
including, but not limited to, the costs, design, initiation and
enrollment (which could be adversely impacted by the coronavirus
pandemic and resulting social distancing), timing, progress and
results of such trials; the timing and our ability to submit
applications for, obtain and maintain regulatory approvals for our
product candidates; the potential success of our reprioritized
pipeline; any cost savings related to our reprioritized pipeline;
our estimates regarding the potential market opportunity for our
product candidates; the potential advantages of our product
candidates; the rate and degree of market acceptance and clinical
utility of our product candidates; our ability to timely develop
and implement anticipated manufacturing, commercialization and
marketing capabilities and strategies for existing product
candidates; our ability to attract and retain key personnel;
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.
Company Contact:Eyenovia,
Inc.John GandolfoChief Financial Officerjgandolfo@eyenovia.com
Investor Contact:The Ruth
GroupTram Bui / Alexander LoboPhone:
646-536-7035/7037tbui@theruthgroup.com / alobo@theruthgroup.com
Media Contact:The Ruth
GroupKirsten ThomasPhone: 508-280-6592kthomas@theruthgroup.com
(Financial Statements to Follow)
EYENOVIA, INC. |
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Balance Sheets |
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December 31, |
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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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Cash and cash
equivalents |
$ |
14,152,601 |
|
|
$ |
19,728,200 |
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|
Prepaid expenses
and other current assets |
|
196,680 |
|
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|
132,756 |
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|
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Total Current
Assets |
|
14,349,281 |
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|
|
19,860,956 |
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|
|
|
|
|
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Property and
equipment, net |
|
230,538 |
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|
36,738 |
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Security
deposit |
|
|
117,800 |
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|
117,800 |
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Total Assets |
$ |
14,697,619 |
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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 |
$ |
1,541,358 |
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$ |
1,509,524 |
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Accrued
compensation |
|
916,873 |
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912,104 |
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Accrued expenses
and other current liabilities |
|
453,430 |
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|
677,213 |
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Total Current
Liabilities |
|
2,911,661 |
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|
|
3,098,841 |
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Deferred rent |
|
|
45,351 |
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41,584 |
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Total
Liabilities |
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2,957,012 |
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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 December 31, 2019 and
2018 |
|
- |
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- |
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Common stock,
$0.0001 par value, 90,000,000 shares authorized; |
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17,100,726 and 11,468,996 shares issued and outstanding |
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as of December 31, 2019 and 2018, respectively |
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1,710 |
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1,147 |
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Additional paid-in
capital |
|
69,409,949 |
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53,388,216 |
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Accumulated
deficit |
|
(57,671,052 |
) |
|
|
(36,514,294 |
) |
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Total
Stockholders' Equity |
|
11,740,607 |
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16,875,069 |
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Total Liabilities
and Stockholders' Equity |
$ |
14,697,619 |
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|
$ |
20,015,494 |
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EYENOVIA, INC. |
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Condensed Statements of Operations |
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For the Three Months Ended |
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For the Years Ended |
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December 31, |
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December 31, |
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2019 |
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2018 |
|
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|
2019 |
|
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2018 |
|
|
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|
(unaudited) |
|
(unaudited) |
|
(unaudited) |
|
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Operating
Expenses: |
|
|
|
|
|
|
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Research and
development |
$ |
3,324,335 |
|
|
$ |
4,125,264 |
|
|
$ |
14,102,449 |
|
|
$ |
11,119,096 |
|
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General and
administrative |
|
1,964,487 |
|
|
|
2,058,098 |
|
|
|
7,206,095 |
|
|
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6,137,347 |
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|
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|
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Total Operating Expenses |
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5,288,822 |
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|
|
6,183,362 |
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21,308,544 |
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17,256,443 |
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Loss From Operations |
|
(5,288,822 |
) |
|
|
(6,183,362 |
) |
|
|
(21,308,544 |
) |
|
|
(17,256,443 |
) |
|
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|
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|
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|
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Other
Income (Expense): |
|
|
|
|
|
|
|
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Interest income
(expense) |
|
47,338 |
|
|
|
255 |
|
|
|
151,786 |
|
|
|
3,335 |
|
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|
|
|
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|
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Net Loss |
$ |
(5,241,484 |
) |
|
$ |
(6,183,107 |
) |
|
$ |
(21,156,758 |
) |
|
$ |
(17,253,108 |
) |
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Net Loss Per Share |
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|
|
- Basic and Diluted |
$ |
(0.31 |
) |
|
$ |
(0.60 |
) |
|
$ |
(1.47 |
) |
|
$ |
(1.82 |
) |
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Weighted Average Number
of |
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Common Shares Outstanding |
|
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|
|
|
|
|
- Basic and Diluted |
$ |
17,100,726 |
|
|
|
10,240,644 |
|
|
|
14,349,738 |
|
|
|
9,476,706 |
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