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Eyenovia Announces Fourth Quarter and Full Year 2017 Financial Results Successfully Completed EYN PG21 Study Evaluating Usability and IOP Lowering with Micro-Therapeutic Latanoprost New York, NY

Key Takeaway: Eyenovia Announces Fourth Quarter and Full Year 2017 Financial Results Successfully Completed EYN PG21 Study Evaluating Usability and IOP Lowering with Micro-Therapeutic Latanoprost New York, NY - April 2, 2018 - Eyenovia, Inc. (NASDAQ: EYEN), a clinical stage biopharmaceuti

Full Press Release Details

Eyenovia Announces Fourth Quarter and
Full Year 2017 Financial Results
Successfully Completed EYN PG21 Study
Evaluating Usability and IOP Lowering with Micro-Therapeutic Latanoprost
New York, NY - April 2, 2018 -
Eyenovia, Inc. (NASDAQ: EYEN), a clinical stage biopharmaceutical company developing a pipeline of ophthalmology products utilizing
its patented piezo-print technology to deliver micro-therapeutics topically to the eye, today announced financial results for the
fourth quarter and full year ended December 31, 2017.
Recent Business Highlights
Dr. Sean Ianchulev, Eyenovia's Chief
Executive Officer and Chief Medical Officer commented, "Eyenovia has made important strides over the last year as we seek
to create a therapeutic paradigm shift in ophthalmology for front-of-the-eye diseases. With our recent successful IPO and a strong
late stage clinical development pipeline, we believe the Company is well positioned to achieve this goal. Our smart, high precision
piezo-print microdosing technology aims to bring ophthalmic treatment into the 21st century, replacing the nearly 100-year
old eye dropper that can miss or overdose the eye causing side effects, ocular toxicity and inconsistent dosing. Using our novel
technology, we believe we have the opportunity to address large unmet needs in Chronic Angle Closure Glaucoma and pediatric myopia
in addition to providing compelling best-in-class alternatives to currently available options in mydriasis and dry eye."
"We have assembled great talent with
an experienced management team and an expanded Board of Directors and Scientific Advisory Board. This is important as we move forward
with a number of late stage programs. The compelling preliminary top-line results from our EYN PG21 trial for IOP lowering further
complement our mydriasis Phase II data which we presented last year and provide preliminary evidence of broad applicability of
our micro-therapeutic approach for different front-of-the-eye indications. This paves the way as we move forward with our MicroProst
IND submission to initiate Phase III trials during the second half of this year. We also believe that the recent confirmation from
the FDA to advance our pediatric myopia program into Phase III development brings us closer to addressing this growing epidemic
that is currently without any FDA approved therapies. I would like to thank all those who helped make this past year transformational
for Eyenovia," concluded Dr. Ianchulev.
The EYN PG21 clinical study evaluated microdose
delivery and the IOP lowering effect of micro-therapeutic latanoprost in the eyes of 30 healthy volunteers who received once-daily
treatment over 3 days and underwent IOP assessments three times per day. Based on preliminary top-line results, piezo-print micro-therapeutic
latanoprost achieved robust IOP reduction at significantly lower level of exposure to drug and toxic preservatives using Eyenovia's
horizontal delivery system and high-precision piezo-print smart technology. The Company is finalizing data analyses from the trial
and expects to announce full and detailed results in the second quarter of 2018.
Fourth Quarter and Full Year 2017 Financial
For the fourth quarter of 2017, net loss
was approximately $2.2 million, or $0.84 per share, compared to a net loss of approximately $1.2 million, or $0.51 per share for
the fourth quarter of 2016. For the full year ended December 31, 2017, the net loss was approximately $5.1 million, or $2.19 per
share. This compares to a net loss of approximately $3.5 million, or $1.56 per share for 2016.
Research and development expenses totaled
approximately $1.7 million for the fourth quarter of 2017, compared to approximately $1.0 million for the same period in 2016,
an increase of 72%. For the full year 2017, research and development expenses increased 29% to approximately $3.8 million compared
to approximately $3.0 million in the prior year.
For the fourth quarter of 2017, general
and administrative expenses were approximately $0.5 million compared with approximately $0.2 million for the fourth quarter of
2016, an increase of 167%. For the full year 2017, general and administrative expenses increased 131% to approximately $1.3 million
versus approximately $0.6 million for the full year of 2016.
Total operating expenses for the fourth
quarter of 2017 were approximately $2.2 million, compared to total operating expenses of approximately $1.2 million for the same
period in 2016, an increase of 87%. For the full year 2017, total operating expenses increased 45% to approximately $5.1 million
compared to $3.5 million for the full year of 2016.
As of December 31, 2017, the Company's
cash was approximately $5.2 million. This amount does not include the $24.5 million in net proceeds from Eyenovia's IPO which
closed in January 2018.
Conference Call and Webcast
The conference call is scheduled to begin
at 8:30 am ET on Monday, April 2, 2018. Participants should dial 1-866-916-2921 (United States) or 1-210-874-7771 (International)
with the conference code 3583799. A live webcast of the conference call will also be available on the investor relations page of
the Company's corporate website at www.eyenoviabio.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
9, 2018. The replay can be accessed by dialing 1-855-859-2056 (United States) or 1-404- 537-3406 (International) with confirmation
Eyenovia is a specialty biopharmaceutical
company building a portfolio of next generation topical eye treatments based on its proprietary delivery and formulation platform
for micro-therapeutics. Eyenovia's pipeline is currently focused on the late-stage development of micro-therapeutics for
glaucoma and other eye diseases.
Forward Looking Statements
Except 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; our ability
to attract and retain key personnel; risks of our clinical trials, including that preliminary top-line results might not be supported
by more detailed analyses or repeatable in future trials; the timing and our ability to submit applications for, obtain and maintain
regulatory approvals for, our product candidates; our ability to implement our business plan to commercialize 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 estimates regarding the potential market opportunity for our product candidates; our commercialization, marketing
and manufacturing capabilities and strategy; our ability to identify additional products, product candidates or technologies with
significant commercial potential that are consistent with our commercial objectives; our expectations regarding our ability to
fund our operating expenses and capital expenditure requirements; intellectual property risks; the impact of government laws and
regulations; our competitive position; and general economic conditions. 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.
Chief Financial Officer
Tram Bui / Alexander Lobo
Phone: 646-536-7035/7037
(Financial Statements to Follow)
December 31,
2017
Assets
Current Assets:
Cash $ 5,249,511
Prepaid expenses and other current assets 37,149
Total Current Assets 5,286,660
Property and equipment, net 27,960
Deferred offering costs 328,700
Total Assets $ 5,643,320
Liabilities and Stockholders' Equity
Current Liabilities:
Accounts payable $ 246,384
Accrued expenses and other current liabilities 306,263
Total Current Liabilities 552,647
Commitments and contingencies -
Stockholders' Equity:
Preferred stock, $0.0001 par value, 36,000,000 shares authorized as of December 31, 2017;
Series A Convertible Preferred Stock, 20,000,000 shares designated as of December 31, 2017, 2,932,431 and 3,232,294 shares issued and outstanding as of December 31, 2017 and 2016, respectively, liquidation preference of $10,996,014 and $12,121,102 as of December 31, 2017 and 2016, respectively 293
Series A-2 Convertible Preferred Stock, 5,714,286 shares designated as of December 31, 2017, 788,827 shares issued and outstanding as of December 31, 2017 and 2016, liquidation preference of $4,141,338 as of December 31, 2017 and 2016 79
Series B Convertible Preferred Stock, 10,000,000 shares designated as of December 31, 2017, 918,983 and 0 shares issued and outstanding as of December 31, 2017 and 2016, respectively, liquidation preference of $6,409,657 and $0 as of December 31, 2017 and 2016, respectively 92
Common stock, $0.0001 par value, 60,000,000 shares authorized as of December 31, 2017, 2,566,530 and 2,266,667 shares issued and outstanding as of December 31, 2017 and 2016, respectively 257
Additional paid-in capital 24,351,138
Accumulated deficit (19,261,186 )
Total Stockholders' Equity 5,090,673
Total Liabilities and Stockholders' Equity $ 5,643,320
For the Three Months Ended For the Year Ended
December 31, December 31,
2017 2016 2017 2016
Operating Expenses:
Research and development $ 1,690,739 $ 980,629 $ 3,816,732 $ 2,966,165
General and administrative 472,676 176,830 1,315,635 568,775
Total Operating Expenses 2,163,415 1,157,459 5,132,367 3,534,940
Loss From Operations (2,163,415 ) (1,157,459 ) (5,132,367 ) (3,534,940 )
Other Income:
Interest income 984 576 2,380 1,497
Total Other Income 984 576 2,380 1,497
Net Loss $ (2,162,431 ) $ (1,156,883 ) $ (5,129,987 ) $ (3,533,443 )
Net Loss Per Share
- Basic and Diluted $ (0.84 ) $ (0.51 ) $ (2.19 ) $ (1.56 )
Weighted Average Number of
Common Shares Outstanding
- Basic and Diluted 2,566,530 2,266,667 2,344,712 2,266,667
Last updated: Apr 2, 2018