Eyenovia, Inc. (NASDAQ: EYEN), a clinical stage ophthalmic
biopharmaceutical company developing a pipeline of microdose array
print (MAP™) therapeutics, today reported its financial results for
the second quarter ended June 30, 2020.
Second Quarter 2020 and Recent Business
Highlights
- Announced exclusive license agreement with Arctic Vision (Hong
Kong) Limited to develop and commercialize MicroPine and MicroLine
in Greater China and South Korea;
- Resumed recruitment of Phase III CHAPERONE study for pediatric
progressive myopia; and
- Preparing to submit the New Drug Application for MicroStat by
the end of 2020.
“Earlier this week, we entered into a license
agreement with Arctic Vision, a China-based ophthalmology company,
to develop and commercialize MicroPine and MicroLine for the
Greater China (mainland China, Hong Kong, Macau and Taiwan) and
South Korean markets. This transaction, which includes payments of
up to $45.75 million in potential license and product development
fees as well as commercial supply terms or royalties, expands the
commercial reach of our programs into markets where the number of
myopic children is estimated at greater than 240 million, more than
eight times that of the United States,” commented Dr. Sean
Ianchulev, Eyenovia’s Chief Executive Officer and Chief Medical
Officer. “In the coming months and subject to any impacts of
COVID-19, we also look forward to initiating our Phase III VISION
trials for MicroLine and plan to submit our New Drug Application
for MicroStat to the FDA by the end of the year.”
Second Quarter 2020 Financial
Review
For the second quarter of 2020, net loss was
approximately $5.0 million, or $(0.25) per share, compared to a net
loss of approximately $5.3 million, or $(0.44) per share for the
second quarter of 2019.
Research and development expenses totaled
approximately $2.9 million for the second quarter of 2020, compared
to approximately $3.6 million for the same period in 2019, a
decrease of approximately 18.3%.
For the second quarter of 2020, general and
administrative expenses were approximately $2.1 million compared to
approximately $1.8 million for the second quarter of 2019, an
increase of approximately 16.3%.
Total operating expenses for the second quarter
of 2020 were approximately $5.0 million, compared to total
operating expenses of approximately $5.4 million for the same
period in 2019, a decrease of approximately 6.7%. Operating
expenses for the second quarter of 2020 include approximately $0.6
million of non-cash stock compensation expense.
As of June 30, 2020, the Company’s cash balance
was approximately $10.2 million.
Conference Call and Webcast
The conference call is scheduled to begin at
4:30pm ET on Wednesday, August 12, 2020. Participants should dial
1-866-916-2921 (United States) or 1-210-874-7771 (International)
with the conference code 7380187. 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 August 19,
2020. The replay can be accessed by dialing 1-855-859-2056 (United
States) or 1-404-537-3406 (International) with confirmation code
7380187.
About EyenoviaEyenovia, Inc.
(NASDAQ: EYEN) is a clinical stage ophthalmic biopharmaceutical
company developing a pipeline of microdose array print (MAP™)
therapeutics. 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 MicroPine for Progressive
MyopiaMicroPine (atropine ophthalmic solution) is 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 MicroLine for
PresbyopiaMicroLine is a 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 MicroStat for
MydriasisMicroStat is Eyenovia's first-in-class
fixed-combination micro-formulation product (tropicamide 1% -
phenylephrine 2.5%) 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 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; our ability to
timely develop, implement and maintain manufacturing,
commercialization and marketing capabilities and strategies for our
product candidates; risks of our clinical trials, including, but
not limited to, the costs, design, initiation and enrollment (which
could still be adversely impacted by COVID-19 and resulting social
distancing), timing, progress and results of such trials; the
potential impacts of COVID-19 on our supply chain; the timing and
our ability to submit applications for, obtain and maintain
regulatory approvals for our product candidates; 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; the potential success of our reprioritized
pipeline; any cost savings related to our reprioritized pipeline;
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.
Eyenovia Contact:Eyenovia,
Inc.John GandolfoChief Financial Officerjgandolfo@eyenovia.com
Eyenovia Investor Contact:The
Ruth GroupAlexander LoboPhone:
646-536-7037alobo@theruthgroup.com
(Financial Statements to Follow)
EYENOVIA, INC. |
|
Condensed Balance Sheets |
|
|
|
|
|
June
30, |
|
December
31, |
|
|
|
2020 |
|
|
|
2019 |
|
|
|
(unaudited) |
|
|
|
|
|
|
|
Assets |
|
|
|
|
|
|
|
|
|
Current Assets: |
|
|
|
|
Cash |
|
$ |
10,186,171 |
|
|
$ |
14,152,601 |
|
Prepaid expenses and other current assets |
|
809,083 |
|
|
|
196,680 |
|
|
|
|
|
|
Total Current Assets |
|
10,995,254 |
|
|
|
14,349,281 |
|
|
|
|
|
|
Property and
equipment, net |
|
313,438 |
|
|
|
230,538 |
|
Security deposit |
|
|
119,035 |
|
|
|
117,800 |
|
|
|
|
|
|
Total Assets |
$ |
11,427,727 |
|
|
$ |
14,697,619 |
|
|
|
|
|
|
Liabilities and Stockholders' Equity |
|
|
|
|
|
|
|
|
Current
Liabilities: |
|
|
|
Accounts payable |
$ |
1,078,700 |
|
|
$ |
1,541,358 |
|
Accrued compensation |
|
573,906 |
|
|
|
916,873 |
|
Accrued expenses and other current liabilities |
|
681,225 |
|
|
|
453,430 |
|
Notes payable - current portion |
|
421,599 |
|
|
|
- |
|
|
|
|
|
|
Total Current Liabilities |
|
2,755,430 |
|
|
|
2,911,661 |
|
|
|
|
|
|
Deferred rent |
|
|
45,345 |
|
|
|
45,351 |
|
Notes payable -
non-current portion |
|
307,646 |
|
|
|
- |
|
|
|
|
|
|
Total Liabilities |
|
3,108,421 |
|
|
|
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 June 30, 2020 and |
|
|
|
as of December 31, 2019 |
|
- |
|
|
|
- |
|
Common stock, $0.0001 par value, 90,000,000 shares authorized; |
|
|
|
19,943,683 and 17,100,726 shares issued and outstanding |
|
|
|
as of June 30, 2020 and December 31, 2019, respectively |
|
1,994 |
|
|
|
1,710 |
|
Additional paid-in capital |
|
76,454,839 |
|
|
|
69,409,949 |
|
Accumulated deficit |
|
(68,137,527 |
) |
|
|
(57,671,052 |
) |
|
|
|
|
|
Total Stockholders' Equity |
|
8,319,306 |
|
|
|
11,740,607 |
|
|
|
|
|
|
Total Liabilities and Stockholders' Equity |
$ |
11,427,727 |
|
|
$ |
14,697,619 |
|
EYENOVIA,
INC. |
|
|
|
|
|
|
|
|
Condensed Statements of Operations |
(unaudited) |
|
|
|
|
|
|
|
|
|
For the Three Months Ended |
|
For the Six Months Ended |
|
June 30, |
|
June 30, |
|
|
2020 |
|
|
|
2019 |
|
|
|
2020 |
|
|
|
2019 |
|
|
|
|
|
|
|
|
|
Operating
Expenses: |
|
|
|
|
|
|
|
Research and development |
$ |
2,915,250 |
|
|
$ |
3,568,022 |
|
|
$ |
6,549,537 |
|
|
$ |
7,576,918 |
|
General and administrative |
|
2,104,163 |
|
|
|
1,809,106 |
|
|
|
3,940,945 |
|
|
|
3,751,869 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total Operating Expenses |
|
5,019,413 |
|
|
|
5,377,128 |
|
|
|
10,490,482 |
|
|
|
11,328,787 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Loss From Operations |
|
(5,019,413 |
) |
|
|
(5,377,128 |
) |
|
|
(10,490,482 |
) |
|
|
(11,328,787 |
) |
|
|
|
|
|
|
|
|
Other
Income: |
|
|
|
|
|
|
|
Small Business Administration Economic |
|
|
|
|
|
|
|
Injury Disaster grant |
|
10,000 |
|
|
|
- |
|
|
|
10,000 |
|
|
|
- |
|
Interest expense |
|
(6,351 |
) |
|
|
- |
|
|
|
(10,032 |
) |
|
|
- |
|
Interest income |
|
199 |
|
|
|
43,616 |
|
|
|
24,039 |
|
|
|
62,891 |
|
|
|
|
|
|
|
|
|
Net Loss |
$ |
(5,015,565 |
) |
|
$ |
(5,333,512 |
) |
|
$ |
(10,466,475 |
) |
|
$ |
(11,265,896 |
) |
|
|
|
|
|
|
|
|
Net Loss Per Share |
|
|
|
|
|
|
|
- Basic and Diluted |
$ |
(0.25 |
) |
|
$ |
(0.44 |
) |
|
$ |
(0.56 |
) |
|
$ |
(0.94 |
) |
|
|
|
|
|
|
|
|
Weighted Average Number of |
|
|
|
|
|
|
|
Common Shares Outstanding |
|
|
|
|
|
|
|
- Basic and Diluted |
|
19,821,215 |
|
|
|
12,034,450 |
|
|
|
18,563,864 |
|
|
|
11,975,035 |
|
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