Latest news with #UFD
Business Insider
20-05-2025
- Business
- Business Insider
Eyenovia provides update on potential merger and Optejet development
Eyenovia (EYEN) provided updates on its potential merger with Betaliq and the ongoing development of its novel Optejet user filled device or UFD. Negotiations continue towards a binding merger agreement with Betaliq, a clinical-stage private pharmaceutical company focused on glaucoma with access to Eyesol, a non-aqueous technology that may address many of the needs of these patients. The companies have agreed to extend the binding exclusivity period set forth in the Letter of Intent until June 7 to allow more time to complete and execute the anticipated merger agreement. Progress in the development of the Optejet UFD continues and remains on track to file for U.S. regulatory approval in September of this year. An approval would provide for potential multiple commercial opportunities either directly with consumers or through eye care practitioner offices as well as potential and existing license partners, including Arctic Vision in China and Korea. A broad restructuring of the company was implemented, reducing overall cash burn by approximately 70% versus one year ago and entering into a debt restructuring agreement earlier this year which defers certain repayment obligations until October 2025.
Yahoo
19-05-2025
- Business
- Yahoo
Eyenovia Provides Updates on Potential Merger with Betaliq and Development of the Optejet User Filled Device (UFD), and Reports First Quarter 2025 Financial Results
Eyenovia and Betaliq continue to negotiate a binding merger agreement consistent with the previously announced signed Letter of Intent Reports continued progress on the development of the user-filled Optejet, and remains on track to file for U.S. device regulatory approval in September 2025 Reduced ongoing cash burn by approximately 70% versus prior year and improved debt repayment terms LAGUNA HILLS, Calif., May 19, 2025 (GLOBE NEWSWIRE) -- Eyenovia, Inc. (NASDAQ: EYEN), an ophthalmic technology company developing the proprietary Optejet® topical ophthalmic medication dispensing platform, today provided updates on its potential merger with Betaliq and the ongoing development of its novel Optejet user filled device (UFD), and reported financial results for the first quarter ended March 31, 2025. Potential Merger with Betaliq Negotiations continue towards a binding merger agreement with Betaliq, a clinical-stage private pharmaceutical company focused on glaucoma with access to Eyesol®, a non-aqueous technology that may address many of the needs of these patients. We have agreed to extend the binding exclusivity period set forth in the Letter of Intent until June 7, 2025, to allow more time to complete and execute the anticipated merger agreement. Development of the Optejet UFD Progress in the development of the Optejet user-filled device (UFD) continues and remains on track to file for U.S. regulatory approval in September of this year. An approval would provide for potential multiple commercial opportunities either directly with consumers or through eye care practitioner offices as well as potential and existing license partners, including Arctic Vision in China and Korea. First Quarter 2025 Financials A broad restructuring of the company was implemented, reducing overall cash burn by approximately 70% versus one year ago and entering into a debt restructuring agreement earlier this year which defers certain repayment obligations until October 2025. Michael Rowe, Chief Executive Officer, commented, 'We remain focused on seeking to maximize shareholder value by working to complete a definitive merger agreement with Betaliq that, if and when completed, will create a new eyecare company with immediate revenue through the sale of our existing FDA-approved products and significant pipeline opportunities that we believe leverage complementary FDA-approved technologies, including our Optejet® platform.' 'At the same time, our engineering team continues to advance the development of our user-filled Optejet, which, if approved, would have the potential to address many of the shortcomings of traditional eyedrops, most notably ease of use and reduced waste. We look forward to submitting an application for device regulatory approval in September of this year and introducing this novel device that can deliver an enhanced experience across a broad range of uses.' 'In addition to these strategic initiatives, we took important measures over the past several months to reduce expenses, strengthen our balance sheet, and extend our cash runway. Perhaps the most notable of these is our entry into a debt restructuring agreement with Avenue Capital, which continues to be very supportive as we work toward finalizing a merger agreement with Betaliq. We look forward to the completion of this potential merger and believe we have set the stage for multiple value inflection points this year,' Mr. Rowe concluded. First Quarter 2025 Financial Review For the first quarter of 2025, net loss was $3.5 million, or $1.59 per share. This compares to a net loss of $10.9 million, or $18.75 per share, for the first quarter of 2024. Research and development expenses totaled $0.7 million for the first quarter of 2025, compared to $4.4 million for the first quarter of 2024, a decrease of 85%. For the first quarter of 2025, general and administrative expenses were $2.4 million, compared to $3.6 million for the first quarter of 2024, a decrease of 35%. Total operating expenses for the first quarter of 2025 were $3.0 million, compared to $10.1 million for the first quarter of 2024. This represents a decrease of 70%. As of March 31, 2025, the Company's unrestricted cash and cash equivalents were $3.9 million, as compared to $2.1 million in unrestricted and restricted cash as of December 31, 2024. About Eyenovia, Inc. Eyenovia, Inc. 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 current commercial portfolio includes clobetasol propionate ophthalmic suspension, 0.05%, for post-surgical pain and inflammation, and Mydcombi® for mydriasis. For more information, please visit Forward Looking Statements Except for historical information, all 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 the potential transaction with Betaliq, our future activities or other future events or conditions, including those relating to the completion of due diligence on and a definitive transaction agreement with Betaliq, the estimated market opportunities for our platform technology, the timing for sales growth of our approved products, and the outcome of the process to explore strategic alternatives to maximize shareholder value. 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: the risk that the proposed transaction with Betaliq does not proceed; risks of our clinical trials, including, but not limited to, the potential advantages of our products, and platform technology; the rate and degree of market acceptance and clinical utility of our products; our estimates regarding the potential market opportunity for our products; reliance on third parties to develop and commercialize our products; the ability of us and our partners to timely develop, implement and maintain manufacturing, commercialization and marketing capabilities and strategies for our products; intellectual property risks; changes in legal, regulatory, legislative and geopolitical 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 product candidates; our competitive position; and our ability to raise additional funds and to make payments on our debt obligations as and when necessary. 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, Lowenlowe@ Eyenovia Investor Contact:Eric RibnerLifeSci Advisors, LLCeric@ 751-4363EYENOVIA, INC. Condensed Balance Sheets March 31, December 31, 2025 2024 (unaudited) Assets Current Assets Cash and cash equivalents $ 3,934,966 $ 2,121,463 License fee and expense reimbursements receivable 25,787 24,827 Security deposits, current 14,968 14,968 Prepaid expenses and other current assets 1,183,262 605,941 Total Current Assets 5,158,983 2,767,199 Security deposits, non-current 182,200 182,200 Operating lease right-of-use asset 642,770 718,360 Total Assets $ 5,983,953 $ 3,667,759 Liabilities and Stockholders' Deficiency Current Liabilities: Accounts payable $ 1,199,961 $ 2,199,768 Accrued compensation 109,934 144,161 Accrued expenses and other current liabilities 3,241,554 3,178,513 Operating lease liabilities - current portion 542,561 575,163 Notes payable - current portion, net of debt discount of $56,954 and $527,870 as of March 31, 2025 and December 31, 2024, respectively 729,999 5,212,532 Convertible notes payable - current portion, net of debt discount of $723,725 and $263,930 as of March 31, 2025 and December 31, 2024, respectively 9,276,275 4,736,070 Total Current Liabilities 15,100,284 16,046,207 Operating lease liabilities - non-current portion 597,670 717,504 Total Liabilities 15,697,954 16,763,711 Stockholders' Deficiency: Preferred stock, $0.0001 par value, 6,000,000 shares authorized; 0 shares issued and outstanding as of March 31, 2025 and December 31, 2024 Common stock, $0.0001 par value, 300,000,000 shares authorized; 2,830,546 and 1,506,369 shares issued and outstanding as of March 31, 2025 and December 31, 2024, respectively 283 151 Additional paid-in capital 189,079,241 182,213,889 Accumulated deficit (198,793,525 ) (195,309,992 ) Total Stockholders' Deficiency (9,714,001 ) (13,095,952 ) Total Liabilities and Stockholders' Deficiency $ 5,983,953 $ 3,667,759 EYENOVIA, INC. Condensed Statements of Operations (unaudited) For the Three Months Ended March 31, 2025 2024 Operating Income Revenue $ 14,720 $ 4,993 Cost of revenue (48 ) (203,027 ) Gross Profit 14,672 (198,034 ) Operating Expenses: Research and development 673,043 4,431,601 Selling, general and administrative 2,372,322 3,637,189 Reacquisition of license rights - 2,000,000 Total Operating Expenses 3,045,365 10,068,790 Loss From Operations (3,030,693 ) (10,266,824 ) Other Income (Expense): Other (expense) income, net 3,687 (97,558 ) Gain on debt extinguishment 89,623 - Interest expense (581,499 ) (678,658 ) Interest income 35,349 120,939 Total Other Expense (452,840 ) (655,277 ) Net Loss $ (3,483,533 ) $ (10,922,101 ) Net Loss Per Share - Basic and Diluted $ (1.59 ) $ (18.75 ) Shares Outstanding - Basic and Diluted 2,188,938 582,584 Sign in to access your portfolio
