Eyenovia Reports First Quarter 2021 Financial Results
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Eyenovia Reports First Quarter 2021 Financial Results
MydCombi PDUFA date confirmed for
Completed patient enrollment in Phase 3 VISION-1 study evaluating MicroLine for the treatment of presbyopia; top-line data on track for Q2
Secures
Company to host conference call and webcast today,
First Quarter 2021 and Recent Business Highlights
U.S. Food and Drug Administration (FDA) accepted the Company’s New Drug Application (NDA) for the Company’s pupil dilation agent MydCombi™ and has notified the Company that the PDUFA date is confirmed forOctober 28, 2021 .- Secured new
$25 million credit facility throughSilicon Valley Bank (SVB). - Completed patient enrollment in the Company’s Phase 3 VISION-1 study of MicroLine for the improvement in near vision in patients with presbyopia and anticipates top-line results in the coming weeks. Results from VISION-1 will help inform the design of a planned second Phase 3 study, VISION-2.
- Announced an exclusive partnership agreement with EVERSANA, a leading commercial service provider to the life science industry, to help commercialize and distribute MydCombi in
the United States . - Appointed Dr.
Julia Haller , renowned ophthalmologist and scientific leader, to Eyenovia’s Board of Directors.
Dr.
“Regarding our Phase 3 VISION-1 clinical study evaluating our proprietary pilocarpine formulation, MicroLine, which is also delivered via the Optejet, for the improvement of near vision in patients with presbyopia, we have completed patient enrollment and anticipate top-line results in the coming weeks. We remain focused on advancing our late-stage clinical programs, while preparing to transition into a commercial-stage ophthalmology company. I believe we have set the stage for a transformational year in 2021,” concluded
First Quarter 2021 Financial Review
For the first quarter of 2021, net loss was approximately $5.4 million, or $(0.21) per share, compared to a net loss of approximately $5.5 million, or $(0.31) per share, for the first quarter of 2020.
For the first quarter of 2021, the Company reported license fee revenue of
Research and development expenses totaled approximately $4.2 million for the first quarter of 2021, compared to approximately $3.6 million for the same period in 2020, an increase of approximately 16.9%.
For the first quarter of 2021, general and administrative expenses were approximately $2.3 million compared to approximately $1.8 million for the first quarter of 2020, an increase of approximately 25.2%.
Total operating expenses for the first quarter of 2021 were approximately $6.5 million, compared to total operating expenses of approximately $5.5 million for the same period in 2020, an increase of approximately 19.7%.
As of March 31, 2021, the Company’s cash balance was approximately $24.9 million. Subsequent to the end of the first quarter, the Company announced a credit facility of up to
Conference Call and Webcast
The conference call is scheduled to begin at
After the live webcast, the event will be archived on Eyenovia’s website for one year.
About Eyenovia, Inc.
About MicroLine for Presbyopia
MicroLine 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 MicroPine for Progressive Myopia
MicroPine (atropine ophthalmic solution) is Eyenovia’s investigational, potentially first-in-class topical treatment for the reduction of pediatric myopia progression, also known as nearsightedness, in children ages 3-12. It has been developed for comfort and ease-of-use in children, and its microdose administration is designed to potentially result in low systemic and ocular drug exposure. MicroPine has been licensed to Bausch Health Companies, Inc. in
About MicroStat (MyCombi™) for Mydriasis
MydCombi 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 eye exams performed every year in the
About Optejet® and Microdose Array Print (MAP™) Therapeutics
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, including estimated regulatory review timing, and market opportunities for our product candidates and platform technology. 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 U.S. Securities and Exchange Commission. In addition, such statements could be affected by risks and uncertainties related to, among other things: fluctuations in our financial results; volatility and uncertainty in the global economy and financial markets in light of the evolving COVID-19 pandemic; our ability to raise additional money to fund our operations for at least the next 12 months as a going concern; our estimates regarding the potential market opportunity for our product candidates and potential revenue from licensing transactions; reliance on third parties; risks of our and our licensees’ 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 and our licensees’ ability to submit applications for, obtain and maintain regulatory approvals for our product candidates; 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; reliance on third parties to develop and commercialize certain of our product candidates; the ability of us and our partners to timely develop, implement and maintain manufacturing, commercialization and marketing capabilities and strategies for certain of our product candidates; the potential advantages of our product candidates and platform technology; the rate and degree of market acceptance and clinical utility of our product candidates; intellectual property risks; our ability to attract and retain key personnel; 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, Eyenovia does not undertake any obligation to update any forward-looking statements.
Eyenovia Contact:
Chief Financial Officer
jgandolfo@eyenovia.com
Eyenovia Investor Contact:
eric@lifesciadvisors.com
(646) 751-4363
Eyenovia Media Contact:
schoinski@pazangahealth.com
(603) 489-5964
| Condensed Balance Sheets | ||||||||||
| 2021 | 2020 | |||||||||
| (unaudited) | ||||||||||
| Assets | ||||||||||
| Current Assets: | ||||||||||
| Cash and cash equivalents | $ | 24,907,048 | $ | 28,371,828 | ||||||
| Deferred license costs | 800,000 | 1,600,000 | ||||||||
| License fee and expense reimbursements receivables | 908,231 | 2,966,039 | ||||||||
| Prepaid expenses and other current assets | 1,409,929 | 453,478 | ||||||||
| Total Current Assets | 28,025,208 | 33,391,345 | ||||||||
| Property and equipment, net | 707,419 | 396,380 | ||||||||
| Security deposit | 119,035 | 119,035 | ||||||||
| Total Assets | $ | 28,851,662 | $ | 33,906,760 | ||||||
| Liabilities and Stockholders' Equity | ||||||||||
| Current Liabilities: | ||||||||||
| Accounts payable | $ | 1,815,117 | $ | 1,461,665 | ||||||
| Accrued compensation | 570,732 | 1,150,672 | ||||||||
| Accrued expenses and other current liabilities | 1,189,092 | 1,480,692 | ||||||||
| Deferred rent - current portion | 6,857 | 7,809 | ||||||||
| Deferred license fee | 12,000,000 | 14,000,000 | ||||||||
| Notes payable - current portion | 783,818 | 97,539 | ||||||||
| Total Current Liabilities | 16,365,616 | 18,198,377 | ||||||||
| Deferred rent - non-current portion | 38,634 | 38,684 | ||||||||
| Notes payable - non-current portion | 307,291 | 365,814 | ||||||||
| Total Liabilities | 16,711,541 | 18,602,875 | ||||||||
| Commitments and contingencies | ||||||||||
| Stockholders' Equity: | ||||||||||
| Preferred stock, |
||||||||||
| 0 shares issued and outstanding as of |
||||||||||
| - | - | |||||||||
| Common stock, |
||||||||||
| 25,623,577 and 24,978,585 shares issued and outstanding | ||||||||||
| as of |
2,563 | 2,498 | ||||||||
| Additional paid-in capital | 94,930,144 | 92,742,306 | ||||||||
| Accumulated deficit | (82,792,586 | ) | (77,440,919 | ) | ||||||
| Total Stockholders' Equity | 12,140,121 | 15,303,885 | ||||||||
| Total Liabilities and Stockholders' Equity | $ | 28,851,662 | $ | 33,906,760 | ||||||
| Condensed Statements of Operations | ||||||||||
| (unaudited) | ||||||||||
| For the Three Months Ended | ||||||||||
| 2021 | 2020 | |||||||||
| Operating Income | ||||||||||
| Revenue | $ | 2,000,000 | $ | - | ||||||
| Cost of revenue | (800,000 | ) | - | |||||||
| Gross Profit | 1,200,000 | - | ||||||||
| Operating Expenses: | ||||||||||
| Research and development | 4,247,726 | 3,634,287 | ||||||||
| General and administrative | 2,300,327 | 1,836,782 | ||||||||
| Total Operating Expenses | 6,548,053 | 5,471,069 | ||||||||
| Loss From Operations | (5,348,053 | ) | (5,471,069 | ) | ||||||
| Other Income (Expense): | ||||||||||
| Interest expense | (5,148 | ) | (3,681 | ) | ||||||
| Interest income | 1,534 | 23,840 | ||||||||
| Net Loss | $ | (5,351,667 | ) | $ | (5,450,910 | ) | ||||
| Net Loss Per Share | ||||||||||
| - Basic and Diluted | $ | (0.21 | ) | $ | (0.31 | ) | ||||
| Weighted Average Number of | ||||||||||
| Common Shares Outstanding | ||||||||||
| - Basic and Diluted | 25,330,563 | 17,308,804 | ||||||||
Source: Eyenovia, Inc.