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, 2020.
First Quarter 2020 and Recent Business
Highlights
- Successfully completed a private placement of units comprised
of common stock and warrants with aggregate net proceeds to the
Company of approximately $5.4 million in March 2020;
- Amended its Exclusive License Agreement with Senju
Pharmaceutical Co., Ltd. allowing Eyenovia to license certain of
its products in China (including, Hong Kong, Macao and Taiwan) and
South Korea; and
- Experiencing delays in initiation of MicroLine Phase III
studies for presbyopia and completion of enrollment of MicroPine
Phase III study for progressive myopia due to global COVID-19
pandemic.
“In the first quarter of 2020, we successfully
strengthened our balance sheet with our private placement, which
should fund the Company’s operations into 2021. Looking ahead, we
are preparing to submit our New Drug Application for MicroStat to
the FDA this year, as well as anticipate initiating our Phase III
trials for MicroLine when the environment becomes safe to do so. We
also look forward to re-initiating enrollment of our MicroPine
Phase III trial, and in the interim, will continue to supply
cartridges of MicroPine by mail and work with our clinical partners
to follow-up virtually with previously enrolled study
participants,” commented Dr. Sean Ianchulev, Eyenovia’s Chief
Executive Officer and Chief Medical Officer. “Our priority remains
the health and safety of our employees, patients, and partners as
well as the communities they serve. We believe that our fearless
Eyenovia spirit of ingenuity and resilience will help ensure that
we persevere through this period of uncertainty.”
First Quarter 2020 Financial
Review
For the first quarter of 2020, net loss was
approximately $5.5 million, or $(0.31) per share, compared to a net
loss of approximately $5.9 million, or $(0.50) per share for the
first quarter of 2019.
Research and development expenses totaled
approximately $3.6 million for the first quarter of 2020, compared
to approximately $4.0 million for the same period in 2019, a
decrease of approximately 9.3%.
For the first quarter of 2020, general and
administrative expenses were approximately $1.8 million compared to
approximately $1.9 million for the first quarter of 2019, a
decrease of approximately 5.5%.
Total operating expenses for the first quarter
of 2020 were approximately $5.5 million, compared to total
operating expenses of approximately $6.0 million for the same
period in 2019, a decrease of approximately 8.1%.
As of March 31, 2020, the Company’s cash balance
was approximately $13.7 million. This includes approximately $5.4
million of net proceeds from Eyenovia’s private placement, which
closed in March 2020.
Conference Call and Webcast
The conference call is scheduled to begin at
4:45pm ET on Wednesday, May 13, 2020. Participants should dial
1-866-916-2921 (United States) or 1-210-874-7771 (International)
with the conference code 4397339. 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 20, 2020.
The replay can be accessed by dialing 1-855-859-2056 (United
States) or 1-404-537-3406 (International) with confirmation code
4397339.
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.
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)
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.
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: impacts of and uncertainty related
to COVID-19; fluctuations in our financial results, 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 COVID-19 on our supply chain; risks of our clinical
trials, including, but not limited to, the costs, design,
initiation and enrollment (which could continue to be adversely
impacted by COVID-19 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@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)
EYENOVIA, INC. |
|
|
|
|
|
Condensed Balance Sheets |
|
|
|
|
|
March
31, |
|
December
31, |
|
|
2020 |
|
2019 |
|
|
(unaudited) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Current Assets: |
|
|
|
|
Cash |
$ |
13,656,091 |
|
|
$ |
14,152,601 |
|
Prepaid expenses and other current assets |
|
860,917 |
|
|
|
196,680 |
|
|
|
|
|
|
Total Current Assets |
|
14,517,008 |
|
|
|
14,349,281 |
|
|
|
|
|
|
Property and
equipment, net |
|
273,739 |
|
|
|
230,538 |
|
Security deposit |
|
|
117,800 |
|
|
|
117,800 |
|
|
|
|
|
|
Total Assets |
$ |
14,908,547 |
|
|
$ |
14,697,619 |
|
|
|
|
|
|
Liabilities and Stockholders' Equity |
|
|
|
|
|
|
|
|
Current
Liabilities: |
|
|
|
Accounts payable |
$ |
1,252,758 |
|
|
$ |
1,541,358 |
|
Accrued compensation |
|
348,009 |
|
|
|
916,873 |
|
Accrued expenses and other current liabilities |
|
513,963 |
|
|
|
453,430 |
|
Short term note payable |
|
423,165 |
|
|
|
- |
|
|
|
|
|
|
Total Current Liabilities |
|
2,537,895 |
|
|
|
2,911,661 |
|
|
|
|
|
|
Deferred rent |
|
|
45,348 |
|
|
|
45,351 |
|
|
|
|
|
|
Total Liabilities |
|
2,583,243 |
|
|
|
2,957,012 |
|
|
|
|
|
|
Commitments and
contingencies |
|
|
|
|
|
|
|
|
Stockholders'
Equity: |
|
|
|
Preferred stock, $0.0001 par value, 6,000,000 shares
authorized; |
|
|
|
0 shares issued and outstanding as of March 31, 2020 and |
|
|
|
as of December 31, 2019 |
|
- |
|
|
|
- |
|
Common stock, $0.0001 par value, 90,000,000 shares authorized; |
|
|
|
19,776,019 and 17,100,726 shares issued and outstanding |
|
|
|
as of March 31, 2020 and December 31, 2019, respectively |
|
1,977 |
|
|
|
1,710 |
|
Additional paid-in capital |
|
75,445,289 |
|
|
|
69,409,949 |
|
Accumulated deficit |
|
(63,121,962 |
) |
|
|
(57,671,052 |
) |
|
|
|
|
|
Total Stockholders' Equity |
|
12,325,304 |
|
|
|
11,740,607 |
|
|
|
|
|
|
Total Liabilities and Stockholders' Equity |
$ |
14,908,547 |
|
|
$ |
14,697,619 |
|
EYENOVIA, INC. |
|
|
|
|
Condensed Statements of Operations |
(unaudited) |
|
|
|
|
|
For the Three Months Ended |
|
March 31, |
|
2020 |
|
2019 |
|
|
|
|
Operating
Expenses: |
|
|
|
Research and development |
$ |
3,634,287 |
|
|
$ |
4,008,896 |
|
General and administrative |
|
1,836,782 |
|
|
|
1,942,763 |
|
|
|
|
|
Total Operating Expenses |
|
5,471,069 |
|
|
|
5,951,659 |
|
|
|
|
|
Loss From Operations |
|
(5,471,069 |
) |
|
|
(5,951,659 |
) |
|
|
|
|
Other
Income: |
|
|
|
Interest expense |
|
(3,681 |
) |
|
|
- |
|
Interest income |
|
23,840 |
|
|
|
19,275 |
|
|
|
|
|
Net Loss |
$ |
(5,450,910 |
) |
|
$ |
(5,932,384 |
) |
|
|
|
|
Net Loss Per Share |
|
|
|
- Basic and Diluted |
$ |
(0.31 |
) |
|
$ |
(0.50 |
) |
|
|
|
|
Weighted Average Number of |
|
|
|
Common Shares Outstanding |
|
|
|
- Basic and Diluted |
|
17,308,804 |
|
|
|
11,919,973 |
|
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