UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
FORM 8-K
CURRENT REPORT
Pursuant to Section 13 or 15(d) of
the Securities Exchange Act of 1934
Date of Report (Date of earliest event reported) August 14, 2018
EYENOVIA, INC.
(Exact name of registrant as specified in its charter)
|
Delaware (State or other jurisdiction of incorporation) |
||
| 001-38365 | 47-1178401 | |
| (Commission File Number) | (IRS Employer Identification No.) | |
501 Fifth Avenue, Suite 1404, New York, NY 10017
(Address of principal executive offices) (Zip Code)
Registrant's telephone number, including area code 917-289-1117
Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions:
| ¨ | Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425) |
| ¨ | Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12) |
| ¨ | Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b)) |
| ¨ | Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c)) |
Indicate by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (§230.405 of this chapter) or Rule 12b-2 of the Securities Exchange Act of 1934 (§240.12b-2 of this chapter).
Emerging Growth Company x
If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. ¨
| Item 2.02. | Results of Operations and Financial Condition. |
On August 14, 2018, Eyenovia, Inc. (the “Company”) issued a press release announcing its financial results for the fiscal second quarter and six months ended June 30, 2018. A copy of the press release is attached hereto as Exhibit 99.1 and is incorporated herein in its entirety by reference.
The information contained in, or incorporated into, Item 2.02, including the press release attached as Exhibit 99.1, is being furnished and shall not be deemed “filed” for the purposes of Section 18 of the Securities Exchange Act of 1934, as amended (the “ Exchange Act” ), or otherwise subject to the liabilities of that section, nor shall it be deemed incorporated by reference into any registration statement or other filing under the Securities Act of 1933, as amended, or the Exchange Act, except as shall be expressly set forth by specific reference to such filing.
| Item 9.01 | Financial Statements and Exhibits. |
| (d) | Exhibits |
|
Exhibit No. |
Description | |
| 99.1 | Press release dated August 14, 2018. |
SIGNATURE
Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.
| EYENOVIA, INC. | ||
| Date: August 14, 2018 | By: | /s/ John Gandolfo |
| Name: John Gandolfo Title: Chief Financial Officer | ||
Exhibit 99.1
Eyenovia Reports Second Quarter 2018 Financial Results
New York, NY – August 14, 2018 – Eyenovia, Inc. (NASDAQ: EYEN), a biopharmaceutical company developing a pipeline of ophthalmology products utilizing its patented piezo-print technology to deliver microdosed medications topically to the eye, today announced financial results for the second quarter ended June 30, 2018.
2Q 2018 Business Highlights
| · | EYN PG21 trial results demonstrated robust intraocular pressure lowering and patient usability; |
| · | Received notice of allowance from USPTO for two additional patent applications for ophthalmic drug delivery; and |
| · | Expanded executive management team by hiring industry veteran Michael Rowe as VP of Marketing. |
Dr. Sean Ianchulev, Eyenovia’s Chief Executive Officer and Chief Medical Officer commented, “In the first half of 2018, we further validated our novel therapeutic platform with compelling IOP lowering and usability results from our EYN PG21 study and with the allowance of two new U.S. patents. As we continue to advance our late stage pipeline and, in particular, accelerate MicroPine for progressive myopia to address an estimated $5 billion potential U.S. market opportunity, we are excited to bring on board Michael Rowe as our VP of Marketing. In the near term, we look forward to leveraging his wealth of knowledge as we plan to submit two Investigational New Drug applications this year as well as the OTC registration for MicroTears for dry eye in 2019. We believe Michael’s commercial ophthalmology experience at both Aerie Pharmaceuticals, Inc. and Allergan plc will be a valuable asset in planning our strategic direction as we near commercialization.”
Second Quarter 2018 Financial Review
For the second quarter of 2018, net loss was approximately $(3.3) million, or $(0.33) per share, compared to a net loss of approximately $(1.0) million, or $(0.43) per share for the second quarter of 2017.
Research and development expenses totaled approximately $2.4 million for the second quarter of 2018, an increase of 221%, compared to approximately $0.8 million for the same period in 2017.
For the second quarter of 2018, general and administrative expenses were approximately $0.9 million, an increase of 304%, compared to approximately $0.2 million for the second quarter of 2017.
Total operating expenses for the second quarter of 2018 were approximately $3.3 million, an increase of 240%, compared to total operating expenses of approximately $1.0 million for the same period in 2017.
As of June 30, 2018, the Company’s cash balance was approximately $24.6 million compared to $27.6 million at March 31, 2018.
The Company reiterated the timeline for its 12-month key clinical milestones:
| · | H2 2018: Initiate MicroStat Phase III trial |
| · | H1 2019: Report MicroStat Phase III trial results |
| · | H1 2019: Initiate MicroPine Phase III trial |
| · | H1 2019: Initiate MicroProst Phase III trial |
| · | H1 2019: MicroTears OTC registration |
Conference Call and Webcast
The conference call is scheduled to begin at 8:30 am ET on Tuesday, August 14, 2018. Participants should dial 1-866-916-2921 (United States) or 1-210-874-7771 (International) with the conference code 7341427. 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 August 21, 2018. The replay can be accessed by dialing 1-855-859-2056 (United States) or 1-404- 537-3406 (International) with confirmation code 7341427.
About Eyenovia
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 microdosing. Eyenovia’s pipeline is currently focused on the late-stage development of microdosed medications for myopia progression, 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 develop and implement commercialization, marketing and manufacturing capabilities and strategies; our estimates regarding the potential market opportunity for our product candidates; the potential advantages of our product candidates; our ability to attract and retain key personnel; the rate and degree of market acceptance and clinical utility of our product candidates; intellectual property risks; 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.
Company Contact:
Eyenovia Inc.
John Gandolfo
Chief Financial Officer
jgandolfo@eyenoviabio.com
Investor Contact:
Tram Bui / Alexander Lobo
The Ruth Group
Phone: 646-536-7035/7037
E-mail: tbui@theruthgroup.com / alobo@theruthgroup.com
Media Contact:
The Ruth Group
Kirsten Thomas
508-280-6592
kthomas@theruthgroup.com
(Financial Statements to Follow)
EYENOVIA, INC.
Condensed Balance Sheets
| June 30, | December 31, | |||||||
| 2018 | 2017 | |||||||
| (unaudited) | ||||||||
| Assets | ||||||||
| Current Assets: | ||||||||
| Cash | $ | 24,561,711 | $ | 5,249,511 | ||||
| Prepaid expenses and other current assets | 243,457 | 37,149 | ||||||
| Total Current Assets | 24,805,168 | 5,286,660 | ||||||
| Property and equipment, net | 16,477 | 27,960 | ||||||
| Deferred offering costs | - | 328,700 | ||||||
| Total Assets | $ | 24,821,645 | $ | 5,643,320 | ||||
| Liabilities and Stockholders’ Equity | ||||||||
| Current Liabilities: | ||||||||
| Accounts payable | $ | 723,006 | $ | 246,384 | ||||
| Accrued expenses and other current liabilities | 556,745 | 306,263 | ||||||
| Total Current Liabilities | 1,279,751 | 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 June 30, 2018 and December 31, 2017, respectively, 0 and 2,932,431 shares issued and outstanding as of June 30, 2018 and December 31, 2017, respectively | - | 293 | ||||||
| Series A-2 Convertible Preferred Stock, 0 and 5,714,286 shares designated as of June 30, 2018 and December 31, 2017, respectively, 0 and 788,827 shares issued and outstanding as of June 30, 2018 and December 31, 2017, respectively | - | 79 | ||||||
| Series B Convertible Preferred Stock, 0 and 10,000,000 shares designated as of June 30, 2018 and December 31, 2017, respectively, 0 and 918,983 shares issued and outstanding as of June 30, 2018 and December 31, 2017, respectively | - | 92 | ||||||
| Common stock, $0.0001 par value, 90,000,000 shares authorized; 9,998,646 and 2,566,530 shares issued and outstanding as of June 30, 2018 and December 31, 2017, respectively | 1,000 | 257 | ||||||
| Additional paid-in capital | 49,550,750 | 24,351,138 | ||||||
| Accumulated deficit | (26,009,856 | ) | (19,261,186 | ) | ||||
| Total Stockholders’ Equity | 23,541,894 | 5,090,673 | ||||||
| Total Liabilities and Stockholders’ Equity | $ | 24,821,645 | $ | 5,643,320 | ||||
EYENOVIA, INC.
Condensed Statements of Operations
(unaudited)
| For the Three Months Ended | For the Six Months Ended | |||||||||||||||
| June 30, | June 30, | |||||||||||||||
| 2018 | 2017 | 2018 | 2017 | |||||||||||||
| Operating Expenses: | ||||||||||||||||
| Research and development | $ | 2,412,164 | $ | 751,930 | $ | 4,506,259 | $ | 1,662,771 | ||||||||
| General and administrative | 908,806 | 224,949 | 2,246,455 | 420,900 | ||||||||||||
| Total Operating Expenses | 3,320,970 | 976,879 | 6,752,714 | 2,083,671 | ||||||||||||
| Loss From Operations | (3,320,970 | ) | (976,879 | ) | (6,752,714 | ) | (2,083,671 | ) | ||||||||
| Other Income: | ||||||||||||||||
| Interest income | 1,907 | 288 | 4,044 | 731 | ||||||||||||
| Net Loss | $ | (3,319,063 | ) | $ | (976,591 | ) | $ | (6,748,670 | ) | $ | (2,082,940 | ) | ||||
| Net Loss Per Share | ||||||||||||||||
| - Basic and Diluted | $ | (0.33 | ) | $ | (0.43 | ) | $ | (0.77 | ) | $ | (0.92 | ) | ||||
| Weighted Average Number of | ||||||||||||||||
| Common Shares Outstanding | ||||||||||||||||
| - Basic and Diluted | 9,998,646 | 2,266,667 | 8,807,864 | 2,266,667 | ||||||||||||