Eyenovia Reports Second Quarter 2024 Financial Results and Provides Corporate Update
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Eyenovia Reports Second Quarter 2024 Financial Results and Provides Corporate Update
Following FDA consultation, announced plans for validation of the Gen-2 Optejet® device and 2025 regulatory submission with Mydcombi™ as lead product
Advanced Phase 3 CHAPERONE study of MicroPine as a treatment of pediatric progressive myopia with preparations for analysis in Q4
Commenced sales activities with focus on Mydcombi in 260+ offices and preparations for launch of clobetasol propionate ophthalmic suspension 0.05%, the first new ophthalmic steroid to enter the market in 15 years
Announced development collaborations with Formosa, Senju and SGN to leverage the Optejet for the
Company to host conference call and webcast today,
Second Quarter 2024 and Recent Business Developments
- Following an FDA meeting in July, announced plans for validation of the advanced Gen-2 Optejet device with production anticipated to begin in Q4 and submission in 2025 for Mydcombi as the lead product. The Gen-2 device was developed to be easier to use and manufacture, bringing the cost of goods for the monthly cartridge towards the company’s goal of
$20 . - Advanced the Phase 3 CHAPERONE study of MicroPine for pediatric progressive myopia. External sources have valued the pediatric progressive myopia market at over
$3.0 billion annually in theU.S. andChina . - Announced collaboration agreements with Formosa Pharmaceuticals,
Senju Pharmaceutical Co., Ltd. and SGN Nanopharma to develop novel therapeutics for use with Eyenovia’s Optejet® dispenser as potential treatments for dry eye disease, estimated to be a$5 billion global addressable market. - Reported training and shipping Mydcombi to 63 new offices from
April 2024 throughJune 30 , prior to the hiring and onboarding of its sales force; on-track to reach 263 new offices by the end of the third quarter. - Completed an equity placement with two of the Company’s largest shareholders.
“Regarding MicroPine, which we are developing for pediatric progressive myopia, we are preparing for analysis of the Phase 3 CHAPERONE data in the fourth quarter that, if successful, would meaningfully accelerate its remaining development path. We also executed several co-development agreements to evaluate novel therapeutics in our Optejet dispenser as potential treatments for dry eye disease, which is estimated to be a
“Also, during the second quarter, we completed a registered direct equity offering with two of our largest shareholders at the market price. These additional funds, together with cash on-hand and other currently available capital resources, are expected to fund our operations through the Phase 3 CHAPERONE data, which we view as a significant upcoming milestone for our company.”
“We continue to take steps to increase the tangible value of our company, which currently includes two FDA-approved products, a third in late Phase 3 development, and co-development agreements that leverage our novel Optejet technology in large market indications. We believe we are very well positioned to be a leading partner to ophthalmic offices by addressing a broad spectrum of physician and patient needs with a portfolio of highly differentiated products.”
Second Quarter 2024 Financial Review
For the second quarter of 2024, net loss was approximately
Research and development expenses totaled approximately
For the second quarter of 2024, general and administrative expenses were approximately
Total operating expenses for the second quarter of 2024 were approximately
As of
Conference Call and Webcast
The conference call is scheduled to begin at
To access the Call me™ feature, which avoids having to wait for an operator, click here.
A live webcast of the conference call will also be available here and 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.
PLEASE GO TO MYDCOMBI.COM FOR IMPORTANT SAFETY INFORMATION for MYDCOMBI™ (tropicamide and phenylephrine hydrochloride ophthalmic spray) 1%/2.5%
PLEASE GO TO CLOBETASOLBID.COM FOR IMPORTANT SAFETY INFORMATION for Clobetasol Proprionate Ophthalmic Suspension 0.05%
About Eyenovia, Inc.
For more information, visit Eyenovia.com.
The Eyenovia Corporate Information slide deck may be found at ir.eyenovia.com/events-and-presentations.
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 statements regarding the plans, strategies and objectives of management, statements regarding future capital requirements, and estimated market opportunities for our products, 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. 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, 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 any disruptions on our supply chain, including the availability of sufficient components and materials used in our products and product candidates; the potential advantages of our products, product candidates and platform technology; the rate and degree of market acceptance and clinical utility of our products and product candidates; our estimates regarding the potential market opportunity for our products and product candidates; reliance on third parties to develop and commercialize our products and product candidates; the ability of us and our partners to timely develop, implement and maintain manufacturing, commercialization and marketing capabilities and strategies for our products and product candidates; the risk of defects in, or returns of, our products; 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; our competitive position; and other risks described from time to time in the “Risk Factors” section of our filings with the
Eyenovia Contact:
Chief Financial Officer
jgandolfo@eyenovia.com
Eyenovia Investor Contact:
eric@lifesciadvisors.com
(646) 751-4363
Eyenovia Media Contact:
Vice President, Commercial Operations
nlowe@eyenovia.com
| Condensed Balance Sheets | |||||||||||
| 2024 | 2023 | ||||||||||
| (unaudited) | |||||||||||
| Assets | |||||||||||
| Current Assets | |||||||||||
| Cash and cash equivalents | $ | 2,300,852 | $ | 14,849,057 | |||||||
| Inventories | 3,052,142 | 109,798 | |||||||||
| Deferred clinical supply costs | 412,140 | 4,256,793 | |||||||||
| License fee and expense reimbursements receivable | 124,173 | 123,833 | |||||||||
| Security deposits, current | - | 1,506 | |||||||||
| Prepaid expenses and other current assets | 1,394,313 | 1,365,731 | |||||||||
| Total Current Assets | 7,283,620 | 20,706,718 | |||||||||
| Property and equipment, net | 3,041,462 | 3,374,384 | |||||||||
| Deferred offering costs | 170,632 | - | |||||||||
| Security deposits, non-current | 197,168 | 197,168 | |||||||||
| Intangible assets | 6,122,945 | 2,122,945 | |||||||||
| Prepaid expenses, non-current | 58,693 | - | |||||||||
| Operating lease right-of-use asset | 1,408,999 | 1,666,718 | |||||||||
| Equipment deposits | 711,441 | 711,441 | |||||||||
| Total Assets | $ | 18,994,960 | $ | 28,779,374 | |||||||
| Liabilities and Stockholders' (Deficiency) Equity | |||||||||||
| Current Liabilities: | |||||||||||
| Accounts payable | $ | 1,436,665 | $ | 1,753,172 | |||||||
| Accrued compensation | 1,278,178 | 1,658,613 | |||||||||
| Accrued expenses and other current liabilities | 2,988,128 | 287,928 | |||||||||
| Operating lease liabilities - current portion | 600,379 | 501,250 | |||||||||
| Notes payable - current portion, net of debt discount of |
|||||||||||
| and |
8,730,043 | 5,329,419 | |||||||||
| Convertible notes payable - current portion, net of debt discount of | |||||||||||
| 815,216 | - | ||||||||||
| Total Current Liabilities | 15,848,609 | 9,530,382 | |||||||||
| Operating lease liabilities - non-current portion | 983,839 | 1,292,667 | |||||||||
| Notes payable - non-current portion, net of debt discount of |
|||||||||||
| 637,500 | 4,355,800 | ||||||||||
| Convertible notes payable - net of debt discount of |
|||||||||||
| and |
3,894,915 | 4,601,431 | |||||||||
| Total Liabilities | 21,364,863 | 19,780,280 | |||||||||
| Stockholders' (Deficiency) Equity: | |||||||||||
| Preferred stock, |
|||||||||||
| 0 shares issued and outstanding as of |
|||||||||||
| 2022 | - | - | |||||||||
| Common stock, |
|||||||||||
| 55,817,921 and 45,553,026 shares issued and outstanding | |||||||||||
| as of |
5,582 | 4,555 | |||||||||
| Additional paid-in capital | 165,091,874 | 154,486,098 | |||||||||
| Accumulated deficit | (167,467,359 | ) | (145,491,559 | ) | |||||||
| Total Stockholders' (Deficiency) Equity | (2,369,903 | ) | 8,999,094 | ||||||||
| Total Liabilities and Stockholders' (Deficiency) Equity | $ | 18,994,960 | $ | 28,779,374 | |||||||
| Condensed Statements of Operations | |||||||||||||||||
| (unaudited) | |||||||||||||||||
| For the Three Months Ended | For the Six Months Ended | ||||||||||||||||
| 2024 | 2023 | 2024 | 2023 | ||||||||||||||
| Operating Income | |||||||||||||||||
| Revenue | $ | 22,625 | $ | - | $ | 27,618 | $ | - | |||||||||
| Cost of revenue | (490,361 | ) | - | (693,388 | ) | - | |||||||||||
| Gross Loss | (467,736 | ) | - | (665,770 | ) | - | |||||||||||
| Operating Expenses: | |||||||||||||||||
| Research and development | 4,597,173 | 2,811,061 | 9,028,774 | 5,333,011 | |||||||||||||
| General and administrative | 3,758,835 | 3,149,809 | 7,396,024 | 6,086,695 | |||||||||||||
| Reacquisition of license rights | 2,864,600 | - | 4,864,600 | - | |||||||||||||
| Total Operating Expenses | 11,220,608 | 5,960,870 | 21,289,398 | 11,419,706 | |||||||||||||
| Loss From Operations | (11,688,344 | ) | (5,960,870 | ) | (21,955,168 | ) | (11,419,706 | ) | |||||||||
| Other Income (Expense): | |||||||||||||||||
| Other income (expense), net | 2,980 | 119,450 | (94,578 | ) | 190,443 | ||||||||||||
| Change in fair value of equity consideration payable |
1,240,800 | - | 1,240,800 | - | |||||||||||||
| Interest expense | (674,001 | ) | (558,003 | ) | (1,352,659 | ) | (1,012,006 | ) | |||||||||
| Interest income | 64,866 | 183,563 | 185,805 | 286,043 | |||||||||||||
| Total Other Income (Expense) | 634,645 | (254,990 | ) | (20,632 | ) | (535,520 | ) | ||||||||||
| Net Loss | $ | (11,053,699 | ) | $ | (6,215,860 | ) | $ | (21,975,800 | ) | $ | (11,955,226 | ) | |||||
| Net Loss Per Share - Basic and Diluted | $ | (0.21 | ) | $ | (0.16 | ) | $ | (0.44 | ) | $ | (0.32 | ) | |||||
| Shares Outstanding - Basic and Diluted | 53,121,760 | 38,093,826 | 49,864,275 | 37,753,694 | |||||||||||||
Source: Eyenovia, Inc.