Full Press Release Details
Eyenovia Reports First Quarter 2018 Financial
Results and Completion of EYN PG21 Study
New York, NY - May 9, 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
first quarter ended March 31, 2018.
1Q 2018 Business Highlights
Dr. Sean Ianchulev, Eyenovia's Chief
Executive Officer and Chief Medical Officer commented, "We started 2018 with the successful completion of our initial public
offering in January, which will help support our late stage clinical pipeline as we steadily advance 3 programs into Phase III
development over the next 12 months. We also recently completed an ancillary clinical trial demonstrating the robust IOP lowering
effect of our high-precision, piezo-print micro-dosing platform in 30 subjects (60 eyes). This clinical trial builds upon previously
reported clinical data from our two Phase II studies in mydriasis and we intend to submit it for presentation to a major medical
conference. We are preparing to submit two INDs by the end of 2018 as we move towards the initiation of the MicroStat Mydriasis
Phase III program later this year and the MicroProst CACG Phase III program in the first half of 2019. Furthermore, we are encouraged
by the FDA feedback to advance MicroPine for pediatric myopia into Phase III development, with the possibility of only one Phase
III trial. With our robust pipeline and highly differentiated technology platform, we believe that our accomplished team is well
positioned to execute on our outlined programs which have the potential to transform the field of ophthalmology and the way in
which we treat front-of-the-eye conditions."
First Quarter 2018 Financial Review
For the first quarter of 2018, net loss
was approximately $(3.4) million, or $(0.45) per share, compared to a net loss of approximately $(1.1) million, or $(0.49) per
share for the first quarter of 2017.
Research and development expenses totaled
approximately $2.1 million for the first quarter of 2018, compared to approximately $0.9 million for the same period in 2017, an
For the first quarter of 2018, general
and administrative expenses were approximately $1.3 million, compared with approximately $0.2 million for the first quarter of
2017, an increase of 583%.
Total operating expenses for the first
quarter of 2018 were approximately $3.4 million, compared to total operating expenses of approximately $1.1 million for the same
period in 2017, an increase of 210%.
As of March 31, 2018, the Company's
cash balance was approximately $27.6 million compared to $5.2 million at December 31, 2017.
Completed initial public offering of 2,730,000
shares of common stock in January 2018. Eyenovia received $24.5 million in net proceeds after underwriting discounts and commissions
and other estimated offering expenses.
The Company reiterated its anticipated
12-month key milestones:
Conference Call and Webcast
The conference call is scheduled to begin
at 8:30 am ET on Wednesday, May 9, 2018. Participants should dial 1-866-916-2921 (United States) or 1-210-874-7771 (International)
with the conference code 3097559. 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 May
16, 2018. The replay can be accessed by dialing 1-855-859-2056 (United States) or 1-404-537-3406 (International) with confirmation
Eyenovia, Inc. (NASDAQ: EYEN) 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: risks involved in clinical trials, including, but
not limited to, the initiation, 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; 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; intellectual
property risks; our current lack of commercialization, marketing and manufacturing capabilities and strategy; our ability to attract
and retain key personnel; 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; 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
E-mail: tbui@theruthgroup.com /
(Financial Statements to Follow)
Condensed Balance Sheets
| March 31, | December 31, | |||||||
| 2018 | 2017 | |||||||
| (unaudited) | ||||||||
| Assets | ||||||||
| Current Assets: | ||||||||
| Cash | $ | 27,602,069 | $ | 5,249,511 | ||||
| Prepaid expenses and other current assets | 358,138 | 37,149 | ||||||
| Total Current Assets | 27,960,207 | 5,286,660 | ||||||
| Property and equipment, net | 22,635 | 27,960 | ||||||
| Deferred offering costs | - | 328,700 | ||||||
| Total Assets | $ | 27,982,842 | $ | 5,643,320 | ||||
| Liabilities and Stockholders' Equity | ||||||||
| Current Liabilities: | ||||||||
| Accounts payable | $ | 549,138 | $ | 246,384 | ||||
| Accrued expenses and other current liabilities | 574,259 | 306,263 | ||||||
| Total Current Liabilities | 1,123,397 | 552,647 | ||||||
| Commitments and contingencies | - | - | ||||||
| Stockholders' Equity: | ||||||||
| Preferred stock, $0.0001 par value, 6,000,000 shares authorized; | ||||||||
| Series A Convertible Preferred Stock, 0 and 20,000,000 shares designated as of March 31, 2018 and December 31, 2017, respectively, 0 and 2,932,431 shares issued and outstanding as of March 31, 2018 and December 31, 2017, respectively | - | 293 | ||||||
| Series A-2 Convertible Preferred Stock, 0 and 5,714,286 shares designated as of March 31, 2018 and December 31, 2017, respectively, 0 and 788,827 shares issued and outstanding as of March 31, 2018 and December 31, 2017, respectively | - | 79 | ||||||
| Series B Convertible Preferred Stock, 0 and 10,000,000 shares designated as of March 31, 2018 and December 31, 2017, respectively, 0 and 918,983 shares issued and outstanding as of March 31, 2018 and December 31, 2017, respectively | - | 92 | ||||||
| Common stock, $0.0001 par value, 90,000,000 shares authorized; 9,936,771 and 2,566,530 shares issued and outstanding as of March 31, 2018 and December 31, 2017, respectively | 994 | 257 | ||||||
| Additional paid-in capital | 49,549,244 | 24,351,138 | ||||||
| Accumulated deficit | (22,690,793 | ) | (19,261,186 | ) | ||||
| Total Stockholders' Equity | 26,859,445 | 5,090,673 | ||||||
| Total Liabilities and Stockholders' Equity | $ | 27,982,842 | $ | 5,643,320 |
Condensed Statements of Operations
| For the Three Months Ended | ||||||||
| March 31, | ||||||||
| 2018 | 2017 | |||||||
| Operating Expenses: | ||||||||
| Research and development | $ | 2,094,095 | $ | 910,841 | ||||
| General and administrative | 1,337,649 | 195,951 | ||||||
| Total Operating Expenses | 3,431,744 | 1,106,792 | ||||||
| Loss From Operations | (3,431,744 | ) | (1,106,792 | ) | ||||
| Other Income: | ||||||||
| Interest income | 2,137 | 443 | ||||||
| Net Loss | $ | (3,429,607 | ) | $ | (1,106,349 | ) | ||
| Net Loss Per Share | ||||||||
| - Basic and Diluted | $ | (0.45 | ) | $ | (0.49 | ) | ||
| Weighted Average Number of | ||||||||
| Common Shares Outstanding | ||||||||
| - Basic and Diluted | 7,561,915 | 2,266,667 |