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 third
quarter ended September 30, 2019.
Third 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;
- Presented data from the MicroStat Phase III MIST-1 and MIST-2
studies for pharmacologic mydriasis at AAOpt; and
- Successfully completed an underwritten public offering of our
common stock in July 2019 with aggregate net proceeds to the
Company of approximately $13.0 million.
“We have been very pleased with our clinical
progress this year as we continue to build a robust late-stage
pipeline in ophthalmology using our next generation, intelligent
microdosing platform. The completion of our MicroStat Phase III
studies for pharmacologic mydriasis as well as the initiation of
our Phase III study for our MicroPine program for the treatment of
progressive myopia earlier this year, have helped demonstrate the
potential of our novel therapies,” commented Dr. Sean Ianchulev,
Eyenovia’s Chief Executive Officer and Chief Medical Officer. “As
we work to maximize the value of our internal portfolio, we
recently conducted a comprehensive strategic review of all our
programs. As a result, we decided to reprioritize our efforts to
focus on MicroPine, MicroStat, and MicroLine for improving near
vision in patients with presbyopia. We believe that these programs
represent areas where there are currently no known drugs approved
or where we can greatly improve the patient experience. As we
approach year end, we are particularly focused on advancing our
MicroLine program towards Phase III development and expect to
initiate and complete the Phase III VISION studies in 2020.”
“With the additional support of our successful
capital raise this summer and the anticipated cost savings from our
pipeline reprioritization, we remain well positioned to fund our
programs. We appreciate the continued support of our shareholders
and look forward to providing additional updates on our clinical
progress,” concluded Dr. Ianchulev.
Third Quarter 2019 Financial
Review
For the third quarter of 2019, net loss was
approximately $4.6 million, or $(0.29) per share, compared to a net
loss of approximately $4.3 million, or $(0.43) per share for the
third quarter of 2018.
Research and development expenses totaled
approximately $3.2 million for the third quarter of 2019, compared
to approximately $2.5 million for the same period in 2018, an
increase of approximately 29%. The increase was primarily
attributable to an increase in contracted services, expanded
research and development activities and an increase in facilities
and other expenses related to supplies and materials.
For the third quarter of 2019, general and
administrative expenses were approximately $1.5 million compared to
approximately $1.8 million for the third quarter of 2018, a
decrease of approximately 19%. This decrease was primarily
attributable to a decrease in legal and professional fees of $0.4
million due to higher expenses in 2018 related to activities
performed to assess various financing opportunities.
Total operating expenses for the third quarter
of 2019 were approximately $4.7 million, compared to total
operating expenses of approximately $4.3 million for the same
period in 2018, an increase of approximately 9%.
As of September 30, 2019, the Company’s cash and
cash equivalents balance was approximately $18.3 million.
Conference Call and Webcast
The conference call is scheduled to begin at
5:00 pm ET on Wednesday, November 13, 2019. Participants should
dial 1-866-916-2921 (United States) or 1-210-874-7771
(International) with the conference code 6128678. 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 November 20,
2019. The replay can be accessed by dialing 1-855-859-2056 (United
States) or 1-404-537-3406 (International) with confirmation code
6128678.
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 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 high
precision microdosing technology combined with pilocarpine could
provide a meaningful improvement in near-vision while enhancing
tolerability and usability.
Upcoming Milestone: Initiate and Complete
MicroLine Phase III Trial in 2020
About MicroPine for Progressive
MyopiaMicroPine 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 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. MicroPine is designed for comfort
and ease-of-use in children, with low systemic and ocular drug
exposure due to microdosing. 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: 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. Designed for use without an anesthetic, we are
developing MicroStat to improve the efficacy and tolerability of
pharmacologic mydriasis.
Upcoming 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
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, 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; the potential success of our reprioritized pipeline; any
cost savings related to our reprioritized pipeline; our ability to
identify new 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; the potential advantages of our product
candidates; 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 timely develop and implement
manufacturing, commercialization and marketing capabilities and
strategies for existing product candidates; our ability to raise
money; 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@eyenoviabio.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)
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EYENOVIA, INC. |
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Condensed Balance Sheets |
|
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September
30, |
|
December
31, |
|
|
|
|
|
2019 |
|
|
|
2018 |
|
|
|
|
|
(unaudited) |
|
|
|
|
|
|
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|
Assets |
|
|
|
|
|
|
|
|
|
|
|
|
Current
Assets: |
|
|
|
|
|
Cash and cash
equivalents |
$ |
18,295,962 |
|
|
$ |
19,728,200 |
|
|
Prepaid expenses
and other current assets |
|
396,977 |
|
|
|
132,756 |
|
|
|
|
|
|
|
|
|
|
Total Current
Assets |
|
18,692,939 |
|
|
|
19,860,956 |
|
|
|
|
|
|
|
|
Property and
equipment, net |
|
71,722 |
|
|
|
36,738 |
|
Security
deposit |
|
|
117,800 |
|
|
|
117,800 |
|
|
|
|
|
|
|
|
|
|
Total Assets |
$ |
18,882,461 |
|
|
$ |
20,015,494 |
|
|
|
|
|
|
|
|
Liabilities and Stockholders' Equity |
|
|
|
|
|
|
|
|
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|
Current
Liabilities: |
|
|
|
|
Accounts
payable |
$ |
1,595,270 |
|
|
$ |
1,509,524 |
|
|
Accrued
compensation |
|
591,494 |
|
|
|
912,104 |
|
|
Accrued expenses
and other current liabilities |
|
246,374 |
|
|
|
677,213 |
|
|
|
|
|
|
|
|
|
|
Total Current
Liabilities |
|
2,433,138 |
|
|
|
3,098,841 |
|
|
|
|
|
|
|
|
|
Deferred rent |
|
45,354 |
|
|
|
41,584 |
|
|
|
|
|
|
|
|
|
|
Total
Liabilities |
|
2,478,492 |
|
|
|
3,140,425 |
|
|
|
|
|
|
|
|
Commitments and
contingencies |
|
|
|
|
|
|
|
|
|
|
Stockholders'
Equity: |
|
|
|
|
Preferred stock,
$0.0001 par value, 6,000,000 shares authorized; |
|
|
|
|
0 shares issued and outstanding as of September 30, 2019 and |
|
|
|
|
as of December 31, 2018 |
|
- |
|
|
|
- |
|
|
Common stock,
$0.0001 par value, 90,000,000 shares authorized; |
|
|
|
|
17,100,726 and 11,468,996 shares issued and outstanding |
|
|
|
|
as of September 30, 2019 and December 31, 2018, respectively |
|
1,710 |
|
|
|
1,147 |
|
|
Additional paid-in
capital |
|
68,831,827 |
|
|
|
53,388,216 |
|
|
Accumulated
deficit |
|
(52,429,568 |
) |
|
|
(36,514,294 |
) |
|
|
|
|
|
|
|
|
|
Total
Stockholders' Equity |
|
16,403,969 |
|
|
|
16,875,069 |
|
|
|
|
|
|
|
|
|
|
Total Liabilities
and Stockholders' Equity |
$ |
18,882,461 |
|
|
$ |
20,015,494 |
|
|
|
|
|
|
|
|
|
|
|
|
EYENOVIA, INC. |
|
|
|
|
|
|
|
|
|
|
Condensed Statements of Operations |
(unaudited) |
|
|
|
|
|
|
|
|
|
|
|
|
|
For the Three Months Ended |
|
For the Nine Months Ended |
|
|
|
September 30, |
|
September 30, |
|
|
|
|
2019 |
|
|
|
2018 |
|
|
|
2019 |
|
|
|
2018 |
|
|
|
|
|
|
|
|
|
|
|
Operating
Expenses: |
|
|
|
|
|
|
|
|
Research and
development |
$ |
3,201,196 |
|
|
$ |
2,487,573 |
|
|
$ |
10,778,114 |
|
|
$ |
6,993,832 |
|
|
General and
administrative |
|
1,489,739 |
|
|
|
1,832,794 |
|
|
|
5,241,608 |
|
|
|
4,079,249 |
|
|
|
|
|
|
|
|
|
|
|
|
|
Total Operating Expenses |
|
4,690,935 |
|
|
|
4,320,367 |
|
|
|
16,019,722 |
|
|
|
11,073,081 |
|
|
|
|
|
|
|
|
|
|
|
|
|
Loss From Operations |
|
(4,690,935 |
) |
|
|
(4,320,367 |
) |
|
|
(16,019,722 |
) |
|
|
(11,073,081 |
) |
|
|
|
|
|
|
|
|
|
|
Other
Income (Expense): |
|
|
|
|
|
|
|
|
Interest income
(expense) |
|
41,557 |
|
|
|
(964 |
) |
|
|
104,448 |
|
|
|
3,080 |
|
|
|
|
|
|
|
|
|
|
|
|
|
Net Loss |
$ |
(4,649,378 |
) |
|
$ |
(4,321,331 |
) |
|
$ |
(15,915,274 |
) |
|
$ |
(11,070,001 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
Net Loss Per Share |
|
|
|
|
|
|
|
|
|
- Basic and Diluted |
$ |
(0.29 |
) |
|
$ |
(0.43 |
) |
|
$ |
(1.19 |
) |
|
$ |
(1.20 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
Weighted Average Number
of |
|
|
|
|
|
|
|
|
|
Common Shares Outstanding |
|
|
|
|
|
|
|
|
|
- Basic and Diluted |
|
16,270,728 |
|
|
|
10,030,296 |
|
|
|
13,422,667 |
|
|
|
9,219,818 |
|
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