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 second
quarter ended June 30, 2019.
Second Quarter 2019 and Recent Business
Highlights
- Enrolled first patient in Phase III CHAPERONE study for
progressive myopia in children;
- Presented positive results from the MicroStat Phase III MIST-1
and MIST-2 registration studies for pharmacologic mydriasis at the
joint American Society of Cataract and Refractive Surgery (ASCRS)
and American Society of Ophthalmic Administrators (ASOA) annual
meeting; and
- Successfully completed an underwritten public offering of its
common stock in July 2019 with aggregate net proceeds to the
Company of approximately $13.0 million.
“We are very pleased with the progress we made
last quarter as we steadily advance our late stage clinical
pipeline and continue to validate our platform technology to change
the treatment paradigm of front and back-of-the-eye diseases. We
recently initiated our Phase III CHAPERONE study for progressive
myopia in children. Progressive myopia represents an estimated $5
billion U.S. market opportunity for Eyenovia and has the potential
to be the first topical therapeutic to treat myopia progression. In
addition, we expect the MILAGRO trial for MicroProst for the
lowering of intraocular pressure in glaucoma to begin enrollment by
the end of this year. MILAGRO will be our third product candidate
to enter Phase III development over the last nine months,”
commented Dr. Sean Ianchulev, Eyenovia’s Chief Executive Officer
and Chief Medical Officer. “With our recent successful capital
raise, we believe Eyenovia is well positioned to continue advancing
both the MicroPine and MicroProst trials and we intend to move our
MicroStat program towards an NDA submission in 2020. We look
forward to executing on our milestones through the remainder of the
year and would like to thank our shareholders for their continued
support.”
Second Quarter 2019 Financial
Review
For the second quarter of 2019, net loss was
approximately $5.3 million, or $(0.44) per share, compared to a net
loss of approximately $3.3 million, or $(0.33) per share for the
second quarter of 2018.
Research and development expenses totaled
approximately $3.6 million for the second quarter of 2019, compared
to approximately $2.4 million for the same period in 2018, an
increase of approximately 48%, due to the continuing advancement of
the Company’s clinical drug pipeline.
For the second quarter of 2019, general and
administrative expenses were approximately $1.8 million compared to
approximately $0.9 million for the second quarter of 2018, an
increase of approximately 99%.
Total operating expenses for the second quarter
of 2019 were approximately $5.4 million, compared to total
operating expenses of approximately $3.3 million for the same
period in 2018, an increase of approximately 62%.
As of June 30, 2019, the Company’s cash and cash
equivalents balance was approximately $9.2 million. This amount
does not include the approximately $13.0 million in aggregate net
proceeds from Eyenovia’s underwritten public offering which closed
in July 2019.
Conference Call and Webcast
The conference call is scheduled to begin at
4:30 pm ET on Monday, August 12, 2019. Participants should dial
1-866-916-2921 (United States) or 1-210-874-7771 (International)
with the conference code 6217226. 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,
2019. The replay can be accessed by dialing 1-855-859-2056 (United
States) or 1-404-537-3406 (International) with confirmation code
6217226.
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 2.5%
-tropicamide 1%) 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 improve the
efficacy and tolerability of pharmacologic mydriasis.
Upcoming 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 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. 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; LAMP (Independent Collaborative Group Trials) Upcoming
Milestone: Complete Enrollment of the Phase III CHAPERONE Study End
of 2020
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 End of 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: Commercial Launch to
Coincide with Potential MicroStat Commercialization
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. 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 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 identify
new product candidates; 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; 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.
Caution: New Drug―Limited by Federal (United
States) law to investigational use.
Company Contact:Eyenovia,
Inc.John GandolfoChief Financial
Officerjgandolfo@eyenoviabio.com
Investor Contact:The Ruth
GroupTram Bui / Alexander
Lobo646-536-7035/7037tbui@theruthgroup.com /
alobo@theruthgroup.com
Media Contact:The Ruth
GroupKirsten Thomas508-280-6592kthomas@theruthgroup.com
EYENOVIA, INC. |
|
|
|
|
Condensed Balance Sheets |
|
|
|
June
30, |
|
December
31, |
|
2019 |
|
2018 |
|
(unaudited) |
|
|
|
|
|
|
Assets |
|
|
|
|
|
|
|
Current Assets: |
|
|
|
Cash and cash equivalents |
$ |
9,239,609 |
|
|
$ |
19,728,200 |
|
Prepaid expenses and other current assets |
|
569,561 |
|
|
|
132,756 |
|
|
|
|
|
Total Current Assets |
|
9,809,170 |
|
|
|
19,860,956 |
|
|
|
|
|
Property and equipment,
net |
|
31,632 |
|
|
|
36,738 |
|
Deferred offering costs |
|
77,376 |
|
|
|
- |
|
Security deposit |
|
117,800 |
|
|
|
117,800 |
|
|
|
|
|
Total Assets |
$ |
10,035,978 |
|
|
$ |
20,015,494 |
|
|
|
|
|
Liabilities and
Stockholders' Equity |
|
|
|
|
|
|
|
Current Liabilities: |
|
|
|
Accounts payable |
$ |
1,802,386 |
|
|
$ |
1,509,524 |
|
Accrued compensation |
|
437,700 |
|
|
|
912,104 |
|
Accrued expenses and other current liabilities |
|
133,146 |
|
|
|
677,213 |
|
|
|
|
|
Total Current Liabilities |
|
2,373,232 |
|
|
|
3,098,841 |
|
|
|
|
|
Deferred rent |
|
44,817 |
|
|
|
41,584 |
|
|
|
|
|
Total Liabilities |
|
2,418,049 |
|
|
|
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 June 30, 2019 and |
|
|
|
as of December 31, 2018 |
|
- |
|
|
|
- |
|
Common stock, $0.0001 par
value, 90,000,000 shares authorized; |
|
|
|
12,053,963 and 11,468,996 shares issued and outstanding |
|
|
|
as of June 30, 2019 and December 31, 2018, respectively |
|
1,205 |
|
|
|
1,147 |
|
Additional paid-in
capital |
|
55,396,914 |
|
|
|
53,388,216 |
|
Accumulated deficit |
|
(47,780,190 |
) |
|
|
(36,514,294 |
) |
|
|
|
|
Total Stockholders' Equity |
|
7,617,929 |
|
|
|
16,875,069 |
|
|
|
|
|
Total Liabilities and Stockholders' Equity |
$ |
10,035,978 |
|
|
$ |
20,015,494 |
|
|
|
|
|
|
|
|
|
EYENOVIA, INC. |
|
|
|
|
|
|
|
|
Condensed Statements of Operations |
(unaudited) |
|
|
|
|
|
|
|
|
|
For the Three Months Ended |
|
For the Six Months Ended |
|
June 30, |
|
June 30, |
|
|
2019 |
|
|
|
2018 |
|
|
|
2019 |
|
|
|
2018 |
|
|
|
|
|
|
|
|
|
Operating
Expenses: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Research and development |
$ |
3,568,022 |
|
|
$ |
2,412,164 |
|
|
$ |
7,576,918 |
|
|
$ |
4,506,259 |
|
General and administrative |
|
1,809,106 |
|
|
|
908,806 |
|
|
|
3,751,869 |
|
|
|
2,246,455 |
|
|
|
|
|
|
|
|
|
Total Operating Expenses |
|
5,377,128 |
|
|
|
3,320,970 |
|
|
|
11,328,787 |
|
|
|
6,752,714 |
|
|
|
|
|
|
|
|
|
Loss From Operations |
|
(5,377,128 |
) |
|
|
(3,320,970 |
) |
|
|
(11,328,787 |
) |
|
|
(6,752,714 |
) |
|
|
|
|
|
|
|
|
Other
Income: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Interest income |
|
43,616 |
|
|
|
1,907 |
|
|
|
62,891 |
|
|
|
4,044 |
|
|
|
|
|
|
|
|
|
Net Loss |
$ |
(5,333,512 |
) |
|
$ |
(3,319,063 |
) |
|
$ |
(11,265,896 |
) |
|
$ |
(6,748,670 |
) |
|
|
|
|
|
|
|
|
Net Loss Per Share |
|
|
|
|
|
|
|
- Basic and Diluted |
$ |
(0.44 |
) |
|
$ |
(0.33 |
) |
|
$ |
(0.94 |
) |
|
$ |
(0.77 |
) |
|
|
|
|
|
|
|
|
Weighted Average Number of |
|
|
|
|
|
|
|
Common Shares Outstanding |
|
|
|
|
|
|
|
- Basic and Diluted |
|
12,034,450 |
|
|
|
9,998,646 |
|
|
|
11,975,035 |
|
|
|
8,807,864 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
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