Eyenovia Reports Third Quarter 2024 Financial Results and Provides Corporate Update

EYEN 11.12.2024

SERA-AI Powered Highlights
Drug:CLO-001 clobetasol propionate ophthalmic suspension 0.05%
Drug:MYD-001 Mydcombi
Diseases:pediatric progressive myopia
Diseases:post-operative inflammation and pain
Date of Upcoming Event:2024-11-12
Name of Upcoming Event:conference call
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Recent News

  • 01.15.2025 - Eyenovia Announces Leading Proxy Advisory Firms, ISS and Glass Lewis, Recommend Eyenovia Stockholders Vote “FOR” Proposed Reverse Stock Split at Upcoming Special Meeting of Stockholders
  • 01.06.2025 - Eyenovia Engages Chardan as Advisor for Review of Strategic Alternatives
  • 12.06.2024 - Eyenovia, Inc. Announces Pricing of $1.9 Million Registered Direct Offering

Recent Filings

  • 01.16.2025 - 424B3 Prospectus [Rule 424(b)(3)]
  • 01.16.2025 - 8-K Current report
  • 01.15.2025 - DEFA14A Additional definitive proxy soliciting materials and Rule 14(a)(12) material

Advanced Phase 3 CHAPERONE study of MicroPine as a treatment of pediatric progressive myopia with preparations for interim analysis this quarter

Commenced the manufacture of registration batches of Mydcombi in its second generation Optejet device

Announced theU.S.launch and commercial availability of clobetasol propionate ophthalmic suspension 0.05% for the treatment of inflammation and pain following ocular surgery

AppointedAndrew Jonesas Chief Financial Officer

Company to host conference call and webcast today,November 12th, at4:30 pm ET

NEW YORK,Nov. 12, 2024(GLOBE NEWSWIRE) --Eyenovia, Inc.(NASDAQ: EYEN), an ophthalmic technology company developing and commercializing advanced products leveraging its proprietary Optejet topical ophthalmic medication dispensing platform, today announced its financial and operating results for the third quarter endedSeptember 30, 2024.

Third Quarter 2024 and Recent Business Developments

  • Advanced the Phase 3 CHAPERONE study of MicroPine for pediatric progressive myopia with plans to conduct an interim analysis this quarter. External sources have valued the myopia market at over$3.0 billionannually in theU.S.andChina.
  • Announced theU.S.launch and commercial availability of clobetasol propionate ophthalmic suspension 0.05%, which is FDA approved for the treatment of post-operative inflammation and pain following ocular surgery.
  • 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 billionglobal addressable market.
  • Commenced the manufacture of registration batches of Mydcombi in its second generation Optejet device, a key step in the FDA approval process for its state-of-the-art Gen-2 Optejet dispensing platform.
  • Reported training and shipping Mydcombi to 230 new offices from April throughSeptember 30th,2024.
  • AppointedAndrew Jonesas Chief Financial Officer.
  • Raised combined net proceeds of$10.7 million.

Michael Rowe, Chief Executive Officer, commented, “We achieved another significant commercial milestone during the third quarter with theU.S.launch of clobetasol, the first new ocular steroid approved in over 15 years. Clobetasol perfectly complements our mydriasis product, Mydcombi, and allows us to further leverage our sales force while adding significant value to eye doctors and surgeons. We also experienced accelerating sales momentum with Mydcombi, now having reached 230 offices as ofSeptember 30th.

“We also took a meaningful step forward in the development of our Gen-2 Optejet device with the commencement of manufacture of registration batches, with Mydcombi as our lead product. We look forward to submitting for FDA approval of this advanced technology with Mydcombi in 2025, and a possible approval in 2026, if successful.

“Regarding MicroPine, which we are developing for pediatric progressive myopia, we are preparing for an interim analysis of the Phase 3 CHAPERONE data this quarter that, if successful, we expect will 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. Together, these indications represent multi-billion-dollar addressable markets in theU.S.alone.”

“With two differentiated commercial products, another in late Phase 3 development, multiple opportunities in dry eye, and the advanced Gen-2 Optejet technology platform, I believe we are creating a foundation from which we can drive significant growth and value creation in the months and years to come,”Mr. Roweconcluded.

Third Quarter 2024 Financial Review

For the third quarter of 2024, net loss was approximately$7.9 million, or$0.11per share, as compared to a net loss of$7.3 million, or$0.18per share, for the third quarter of 2023.

Research and development expenses totaled approximately$3.5 millionfor the third quarter of 2024, which was relatively consistent with$3.6 millionreported for the third quarter of 2023.

For the third quarter of 2024, selling, general and administrative expenses were approximately$3.7 million, compared to$2.9 millionfor the third quarter of 2023, an increase of approximately 27.3% reflecting the establishment of the Company’s sales force in 2024.

Total operating expenses for the third quarter of 2024 were approximately$7.2 million, compared to approximately$6.5 millionfor the third quarter of 2023. This represents an increase of approximately 10.6%. The third quarter 2024 operating expense figure includes approximately$1.2 millionof non-cash expenses.

As ofSeptember 30, 2024, the Company’s unrestricted cash and cash equivalents were approximately$7.2 million.Eyenoviacontinues to evaluate a range of options to secure long-term financing.

Conference Call and Webcast

The conference call is scheduled to begin at4:30 pm ETtoday,November 12th. Participants should dial 1-877-407-9039 (domestic) or 1-201-689-8470 (international), and reference conference ID 13748714.

To access the Call meTM feature, which avoids having to wait for an operator, clickhere.

A live webcast of the conference call will also be availablehereand on the investor relations page of the Company's corporate website atwww.eyenovia.com. After the live webcast, the event will be archived on Eyenovia’s website for one year.

PLEASE GO TOMYDCOMBI.COMFOR IMPORTANT SAFETY INFORMATION for MYDCOMBITM (tropicamide and phenylephrine hydrochloride ophthalmic spray) 1%/2.5%

PLEASE GO TOCLOBETASOLBID.COMFOR IMPORTANT SAFETY INFORMATION for Clobetasol Proprionate Ophthalmic Suspension 0.05%

About Eyenovia, Inc.

Eyenovia, Inc.(NASDAQ: EYEN) is an ophthalmic technology company developing and commercializing advanced products leveraging its proprietary Optejet topical ophthalmic medication dispensing platform. The Optejet is especially useful in chronic front-of-the-eye diseases due to its ease of use, enhanced safety and tolerability, and potential for superior compliance versus standard eye drops. Together, these benefits may combine to produce better treatment options and outcomes for patients and providers. The company’s pre-NDA candidate, MicroPine, is being developed for pediatric progressive myopia, a global epidemic impacting hundreds of millions of children worldwide and representing a multi-billion-dollar addressable market. The company’s current commercial portfolio includes clobetasol propionate ophthalmic suspension, 0.05%, for post-surgical pain and inflammation, and Mydcombi® for mydriasis.Eyenoviahas also secured licensing and development agreements for additional multi-billion-dollar indications where the Optejet may be advantageous, including dry eye. For more information, visitEyenovia.com.

The Eyenovia Corporate Information slide deck may be found atir.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: the availability of sufficient financial resources to continue clinical development and commercialization of our products; 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 theU.S. Securities and Exchange Commission, including those described in our Annual Report on Form 10-K as well as our Quarterly Reports on Form 10-Q, and supplemented from time to time by our Current Reports on Form 8-K. 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,Eyenoviadoes not undertake any obligation to update any forward-looking statements.

Eyenovia Contact:Eyenovia, Inc.Andrew JonesChief Financial Officerajones@eyenovia.com

Eyenovia Investor Contact:Eric RibnerLifeSci Advisors, LLCeric@lifesciadvisors.com(646) 751-4363

Eyenovia Media Contact:Eyenovia, Inc.Norbert LoweVice President, Commercial Operationsnlowe@eyenovia.com

EYENOVIA, INC.
Condensed Balance Sheets
September 30,December 31,
20242023
(unaudited)
Assets
Current Assets
Cash and cash equivalents$7,188,129$14,849,057
Inventories2,967,256109,798
Deferred clinical supply costs408,8324,256,793
License fee and expense reimbursements receivable137,594123,833
Security deposits, current-1,506
Prepaid expenses and other current assets987,7541,365,731
Total Current Assets11,689,56520,706,718
Property and equipment, net2,752,4043,374,384
Security deposits, non-current197,526197,168
Intangible assets6,122,9452,122,945
Prepaid expenses, non-current46,520-
Operating lease right-of-use asset1,275,6901,666,718
Equipment deposits711,441711,441
Total Assets$22,796,091$28,779,374
Liabilities and Stockholders' Equity
Current Liabilities:
Accounts payable$1,573,940$1,753,172
Accrued compensation1,656,8321,658,613
Accrued expenses and other current liabilities2,518,086287,928
Operating lease liabilities - current portion604,647501,250
Notes payable - current portion, net of debt discount of$562,711
and$503,914as ofSeptember 30, 2024andDecember 31, 2023, respectively6,168,5935,329,419
Convertible notes payable - current portion, net of debt discount of
$72,467and$0as ofSeptember 30, 2024andDecember 31, 2023, respectively3,260,866-
Total Current Liabilities15,782,9649,530,382
Accrued expenses and other non-current liabilities316,275-
Operating lease liabilities - non-current portion836,4341,292,667
Notes payable - non-current portion, net of debt discount of$0and
$448,367as ofSeptember 30, 2024andDecember 31, 2023, respectively637,5004,355,800
Convertible notes payable - non-current portion, net of debt discount of$163,051
and$398,569as ofSeptember 30, 2024andDecember 31, 2023, respectively1,503,6154,601,431
Total Liabilities19,076,78819,780,280
Stockholders' Equity:
Preferred stock,$0.0001par value, 6,000,000 shares authorized;
0 shares issued and outstanding as ofSeptember 30, 2024andDecember 31, 2023--
Common stock,$0.0001par value, 300,000,000 shares authorized;
86,375,958 and 45,553,026 shares issued and outstanding
as ofSeptember 30, 2024andDecember 31, 2023, respectively8,6384,555
Additional paid-in capital179,065,877154,486,098
Accumulated deficit(175,355,212)(145,491,559)
Total Stockholders' Equity3,719,3038,999,094
Total Liabilities and Stockholders' Equity$22,796,091$28,779,374

EYENOVIA, INC.
Condensed Statements of Operations
(unaudited)
For the Three Months EndedFor the Nine Months Ended
September 30,September 30,
2024202320242023
Operating Income
Revenue$1,625$1,198$29,243$1,198
Cost of revenue(132,522)(13,416)(825,910)(13,416)
Gross Loss(130,897)(12,218)(796,667)(12,218)
Operating Expenses:
Research and development3,471,9393,578,11312,500,7138,911,124
Selling, general and administrative3,729,0912,929,85511,125,1159,016,550
Reacquisition of license rights--4,864,600-
Total Operating Expenses7,201,0306,507,96828,490,42817,927,674
Loss From Operations(7,331,927)(6,520,186)(29,287,095)(17,939,892)
Other Income (Expense):
Other income (expense), net1,184(348,226)(93,394)(157,783)
Change in fair value of equity consideration payable--1,240,800-
Interest expense(602,109)(679,222)(1,954,768)(1,691,228)
Interest income44,999208,901230,804494,944
Total Other Expense(555,926)(818,547)(576,558)(1,354,067)
Net Loss$(7,887,853)$(7,338,733)$(29,863,653)$(19,293,959)
Net Loss Per Share - Basic and Diluted$(0.11)$(0.18)$(0.53)$(0.50)
Shares Outstanding - Basic and Diluted69,558,32540,139,69756,476,87638,563,074

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Source: Eyenovia, Inc.

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