Eyenovia Reports Second Quarter 2021 Financial Results
Eyenovia announced positive topline data from its Phase 3 VISION-1 trial evaluating MicroLine for presbyopia, demonstrating a 7.7-fold improvement in near vision over placebo. The company is set to launch a second Phase 3 trial, VISION-2, by year-end 2021. MydCombi's PDUFA date is confirmed for October 28, 2021. Financially, the company reported a net loss of $4.8 million for Q2 2021, with operating expenses up 19% year-over-year. Cash balance stands at approximately $27.2 million, including funding from a credit facility. Earnings call scheduled for August 11, 2021.
- Positive topline data from Phase 3 VISION-1 trial of MicroLine.
- 7.7 times improvement in near vision compared to placebo.
- Plans to initiate Phase 3 trial VISION-2 by year-end 2021.
- MydCombi PDUFA date confirmed for October 28, 2021.
- Cash balance of approximately $27.2 million as of June 30, 2021.
- Net loss of $4.8 million in Q2 2021, slightly better than Q2 2020.
- Operating expenses increased by 19% year-over-year.
Announced positive topline data from its Phase 3 VISION-1 study evaluating MicroLine for the treatment of presbyopia
Company on track to initiate second Phase 3 presbyopia trial, VISION-2, by year-end 2021
MydCombi PDUFA date confirmed for October 28, 2021
Company to host conference call and webcast today, August 11, at 4:30pm ET
NEW YORK, Aug. 11, 2021 (GLOBE NEWSWIRE) -- Eyenovia, Inc. (NASDAQ: EYEN), a clinical stage ophthalmic company developing a pipeline of advanced therapeutics based on its proprietary microdose array print (MAP™) platform technology, today announced its financial and operating results for the second quarter ended June 30, 2021.
Second Quarter 2021 and Recent Business Highlights
- Announced positive topline data from the company’s Phase 3 VISION-1 clinical trial of its proprietary presbyopia therapy, MicroLine.
Select data highlights include:- Subjects treated with MicroLine
2% were 7.7 times more likely to achieve the primary endpoint of 3-line or greater improvement in near vision as compared to placebo (Odds Ratio=7.7; statistically significant difference p<0.05). 71% of patients reported a meaningful improvement in near vision according to an exit survey conducted by study investigators.- MicroLine had a favorable safety profile, with no serious adverse events and fewer than
3% of study participants reporting headache (including brow ache), instillation discomfort or moderate hyperemia.
- Subjects treated with MicroLine
- Based on the positive results from the VISION-1 trial, the company is advancing plans to initiate a second Phase 3 trial of MicroLine, VISION-2, by year end 2021.
- PDUFA date from the Company’s pupil dilation agent, MydCombi™, confirmed for October 28, 2021.
- Participated in a panel discussion on presbyopia at Eyecelerator 2021
- Participated in the Ladenburg Thalmann 2021 Healthcare Conference and the William Blair Biotech Focus Conference 2021
Dr. Sean Ianchulev, Chief Executive Officer and Chief Medical Officer of Eyenovia, commented, “We are pleased to report another productive quarter for Eyenovia. The recently announced positive topline data from our Phase 3 VISION-1 trial of MicroLine in presbyopia highlights the impressive potential of our ophthalmic and Optejet® platform. With compelling efficacy and tolerability in patients, MicroLine, if approved, could become a promising new alternative for patients who desire a temporary, on demand alternative to reading glasses, particularly in indoor or low light conditions, a clear differentiator versus many other presbyopia therapeutics in development. We continue to anticipate initiating a second Phase 3 trial, VISION-2, by the end of the year, and anticipate topline data in mid-2022.
“We are actively preparing for our MydCombi PDUFA date, which has been confirmed for October 28 of this year. We believe MydCombi, our mydriatic candidate, has the potential to become the new standard of care for the approximately 100 million comprehensive eye exams conducted every year in the U.S. alone.
“The MicroLine and MydCombi programs, together with MicroPine, which we have out-licensed to Bausch Health and Arctic Vision for up to
Second Quarter 2021 Financial Review
For the second quarter of 2021, net loss was approximately
For the second quarter of 2021, the Company reported license fee revenue from its Arctic Vision license agreement of
Research and development expenses for the three months ended June 30, 2021 totaled
For the second quarter of 2021, general and administrative expenses totaled
Total operating expenses for the second quarter of 2021 were approximately
As of June 30, 2021, the Company’s cash balance was approximately
Conference Call and Webcast
The conference call is scheduled to begin at 4:30pm ET on Wednesday, August 11, 2021. Participants should dial 855-327-6837 (domestic) or 631-891-4304 (international) with the conference code 10015927. 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.
About Eyenovia, Inc.
Eyenovia, Inc. (NASDAQ: EYEN) is a clinical stage ophthalmic biopharmaceutical company developing a pipeline of microdose array print (MAP) therapeutics. Eyenovia is currently focused on the late-stage development of microdosed medications for presbyopia, myopia progression and mydriasis. For more information, visit www.eyenovia.com.
The Eyenovia Corporate Information slide deck may be found at ir.eyenovia.com/events-and-presentations.
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 the United States and Canada, and Arctic Vision (Hong Kong) Limited in Greater China and South Korea.
About MicroStat (MydCombi™) for Mydriasis
MydCombi is Eyenovia's first-in-class fixed-combination micro-formulation product (tropicamide
About Optejet® and Microdose Array Print (MAP™) Therapeutics
Eyenovia'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
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 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 in some cases 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: risks of our 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 timing of, and our ability to submit applications for, obtaining and maintaining regulatory approvals for our product candidates; the potential impacts of COVID-19 and related economic disruptions on our supply chain, including the availability of sufficient components and materials used in 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; our estimates regarding the potential market opportunity for our product candidates; reliance on third parties to develop and commercialize our product candidates; the ability of us and our partners to timely develop, implement and maintain manufacturing, commercialization and marketing capabilities and strategies 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, Eyenovia does not undertake any obligation to update any forward-looking statements.
Eyenovia Contact:
Eyenovia, Inc.
John Gandolfo
Chief Financial Officer
jgandolfo@eyenovia.com
Eyenovia Investor Contact:
Eric Ribner
LifeSci Advisors, LLC
eric@lifesciadvisors.com
(646) 751-4363
Eyenovia Media Contact:
Sam Choinski
Pazanga Health Communications
schoinski@pazangahealth.com
(603) 489-5964
| EYENOVIA, INC. | ||||||||||
| Condensed Balance Sheets | ||||||||||
| June 30, | December 31, | |||||||||
| 2021 | 2020 | |||||||||
| (unaudited) | ||||||||||
| Assets | ||||||||||
| Current Assets: | ||||||||||
| Cash and cash equivalents | $ | 27,176,843 | $ | 28,371,828 | ||||||
| Deferred license costs | - | 1,600,000 | ||||||||
| License fee and expense reimbursements receivables | 899,332 | 2,966,039 | ||||||||
| Prepaid expenses and other current assets | 1,418,834 | 453,478 | ||||||||
| Total Current Assets | 29,495,009 | 33,391,345 | ||||||||
| Property and equipment, net | 968,881 | 396,380 | ||||||||
| Security deposit | 119,035 | 119,035 | ||||||||
| Total Assets | $ | 30,582,925 | $ | 33,906,760 | ||||||
| Liabilities and Stockholders' Equity | ||||||||||
| Current Liabilities: | ||||||||||
| Accounts payable | $ | 1,667,634 | $ | 1,461,665 | ||||||
| Accrued compensation | 870,666 | 1,150,672 | ||||||||
| Accrued expenses and other current liabilities | 1,054,923 | 1,480,692 | ||||||||
| Deferred rent - current portion | 6,857 | 7,809 | ||||||||
| Deferred license fee | 10,000,000 | 14,000,000 | ||||||||
| Notes payable - current portion | 959,763 | 97,539 | ||||||||
| Total Current Liabilities | 14,559,843 | 18,198,377 | ||||||||
| Deferred rent - non-current portion | 37,632 | 38,684 | ||||||||
| Notes payable - non-current portion | 6,994,893 | 365,814 | ||||||||
| Total Liabilities | 21,592,368 | 18,602,875 | ||||||||
| Commitments and contingencies | ||||||||||
| Stockholders' Equity: | ||||||||||
| Preferred stock, | ||||||||||
| 0 shares issued and outstanding as of June 30, 2021 and | ||||||||||
| December 31, 2020, respectively | - | - | ||||||||
| Common stock, | ||||||||||
| 25,946,646 and 24,978,585 shares issued and outstanding | ||||||||||
| as of June 30, 2021 and December 31, 2020, respectively | 2,595 | 2,498 | ||||||||
| Additional paid-in capital | 96,621,948 | 92,742,306 | ||||||||
| Accumulated deficit | (87,633,986 | ) | (77,440,919 | ) | ||||||
| Total Stockholders' Equity | 8,990,557 | 15,303,885 | ||||||||
| Total Liabilities and Stockholders' Equity | $ | 30,582,925 | $ | 33,906,760 | ||||||
| EYENOVIA, INC. | |||||||||||||||||
| Condensed Statements of Operations | |||||||||||||||||
| (unaudited) | |||||||||||||||||
| For the Three Months Ended | For the Six Months Ended | ||||||||||||||||
| June 30, | June 30, | ||||||||||||||||
| 2021 | 2020 | 2021 | 2020 | ||||||||||||||
| Operating Income | |||||||||||||||||
| Revenue | $ | 2,000,000 | $ | - | $ | 4,000,000 | $ | - | |||||||||
| Cost of revenue | (800,000 | ) | - | (1,600,000 | ) | - | |||||||||||
| Gross Profit | 1,200,000 | - | 2,400,000 | - | |||||||||||||
| Operating Expenses: | |||||||||||||||||
| Research and development | 3,616,382 | 2,915,250 | 7,864,108 | 6,549,537 | |||||||||||||
| General and administrative | 2,347,191 | 2,104,163 | 4,647,518 | 3,940,945 | |||||||||||||
| Total Operating Expenses | 5,963,573 | 5,019,413 | 12,511,626 | 10,490,482 | |||||||||||||
| Loss From Operations | (4,763,573 | ) | (5,019,413 | ) | (10,111,626 | ) | (10,490,482 | ) | |||||||||
| Other Income (Expense): | |||||||||||||||||
| Small Business Administration Economic | |||||||||||||||||
| Injury Disaster Grant | - | 10,000 | - | 10,000 | |||||||||||||
| Interest expense | (78,047 | ) | (6,351 | ) | (83,195 | ) | (10,032 | ) | |||||||||
| Interest income | 220 | 199 | 1,754 | 24,039 | |||||||||||||
| - | |||||||||||||||||
| Net Loss | $ | (4,841,400 | ) | $ | (5,015,565 | ) | $ | (10,193,067 | ) | $ | (10,466,475 | ) | |||||
| Net Loss Per Share | |||||||||||||||||
| - Basic and Diluted | $ | (0.19 | ) | $ | (0.25 | ) | $ | (0.40 | ) | $ | (0.56 | ) | |||||
| Weighted Average Number of | |||||||||||||||||
| Common Shares Outstanding | |||||||||||||||||
| - Basic and Diluted | 25,927,303 | 19,821,215 | 25,630,572 | 18,563,864 | |||||||||||||
FAQ
What are the Phase 3 VISION-1 study results for EYEN?
When is the PDUFA date for MydCombi from EYEN?
What is Eyenovia's financial status for Q2 2021?
What is the expected timeline for the VISION-2 trial for EYEN?
How much cash does EYEN have as of June 30, 2021?
