Company concurrently focused on completing development of the Gen-2 user-filled Optejet® device by 3Q 2025 while reducing spend by over 60%NEW YORK, Jan. 06, 2025 (GLOBE NEWSWIRE) -- Eyenovia, Inc. (NASDAQ: EYEN) (“Eyenovia” or the “Company”), an ophthalmic technology company focused on completing development of its proprietary Optejet topical ophthalmic medication dispensing platform, today announced that it has engaged Chardan as its financial advisor in connection with its evaluation of strategic alterna ...

Avenue Capital agrees to Company’s deferral of principal and interest payments on its outstanding debt until the end of February 2025 Eyenovia continues to evaluate a broad range of strategic alternatives to maximize stakeholder value NEW YORK, Nov. 22, 2024 (GLOBE NEWSWIRE) -- Eyenovia, Inc. (NASDAQ: EYEN), an ophthalmic technology company, today provided an update on its ongoing restructuring efforts. The Company announced today that Avenue Capital Management L.P. has agreed to support a potential restruc ...

Core Viewpoint - Eyenovia, Inc. has decided to terminate the phase III study of its investigational drug-device product, MicroPine, for pediatric progressive myopia after an independent Data Review Committee concluded it was unlikely to meet its primary endpoint [1][2][4]. Company Developments - The Data Review Committee evaluated safety and efficacy data from 252 patients and found no significant difference in myopia progression between treatment groups and placebo [3]. - Following the DRC's feedback, Eyenovia is conducting a thorough review of the study data to determine next steps [4]. - The company's stock plummeted 70% after the announcement, with a year-to-date decline of 95.1%, compared to the industry's 10.5% decline [4]. Marketed Portfolio - Eyenovia currently has two FDA-approved products: Mydcombi and clobetasol propionate, which are yet to gain significant market traction [5]. - Mydcombi was approved in May 2023 and launched in August 2023, while clobetasol propionate received FDA approval in March 2024 and was launched in Q3 2024 [6]. Clinical Pipeline - Besides MicroPine, Eyenovia has other candidates in mid-stage development targeting various dry eye indications [7]. Strategic Options - The company is exploring ways to maximize stakeholder value, which may include cost-cutting measures, business combinations, reverse mergers, or asset sales [4].

On Friday, Eyenovia, Inc. EYEN stock is trading lower after an update from the Phase 3 CHAPERONE study evaluating its proprietary drug-device combination of low-dose atropine in the company’s Optejet dispensing platform pediatric progressive myopia.Progressive myopia is a type of nearsightedness that worsens over time due to the eyeball growing too long.The company said that an independent Data Review Committee (DRC) reviewed the CHAPERONE data and found that the trial is not meeting its primary endpoint of ...

A review of study data by an independent Data Review Committee found that CHAPERONE is not meeting its primary three-year efficacy endpoint Company to discontinue study, review full data set, and evaluate next steps for the program NEW YORK, Nov. 15, 2024 (GLOBE NEWSWIRE) -- Eyenovia, Inc. (NASDAQ: EYEN), an ophthalmic technology company, today announced that a review of the CHAPERONE data by an independent Data Review Committee (DRC) found that the trial is not meeting its primary endpoint of a less than 0 ...

Eyenovia, Inc. (NASDAQ:EYEN) Q3 2024 Earnings Conference Call November 12, 2024 4:30 PM ET Company Participants Eric Ribner - IR Michael Rowe - CEO Bren Kern - COO Andy Jones - CFO Conference Call Participants Matthew Caufield - H.C. Wainwright Matt Kaplan - Ladenburg Thalmann Lachlan Hanbury-Brown - William Blair Kemp Dolliver - Brookline Capital Markets Len Yaffe - Stoc Doc Partners Operator Greetings and welcome to Eyenovia's Third Quarter 2024 Earnings Call. At this time, all participants are in a liste ...

Eyenovia, Inc. (EYEN) came out with a quarterly loss of $0.11 per share versus the Zacks Consensus Estimate of a loss of $0.13. This compares to loss of $0.18 per share a year ago. These figures are adjusted for non-recurring items.This quarterly report represents an earnings surprise of 15.38%. A quarter ago, it was expected that this company would post a loss of $0.17 per share when it actually produced a loss of $0.18, delivering a surprise of -5.88%.Over the last four quarters, the company has surpassed ...

Financial Performance - Eyenovia reported net losses of $7.9 million and $7.3 million for the three months ended September 30, 2024 and 2023, respectively[87]. - The company has an accumulated deficit of approximately $175.4 million as of September 30, 2024[87]. - Revenue for the three months ended September 30, 2024, totaled $1,625, primarily from Mydcombi sales, with a gross loss due to inventory write-downs of approximately $0.1 million[95]. - Revenue for the nine months ended September 30, 2024, totaled $29,243, offset by cost of revenues of $825,910, with inventory write-downs of approximately $0.8 million[100]. - The company reported net losses of $29.9 million for the nine months ended September 30, 2024, compared to $19.3 million for the same period in 2023[110]. - Net cash used in operating activities for the nine months ended September 30, 2024 was approximately $24.0 million, compared to $17.5 million for the same period in 2023, reflecting an increase of 37.1%[112]. - Net cash provided by financing activities for the nine months ended September 30, 2024 totaled approximately $16.5 million, a decrease of 14.1% from $19.2 million in 2023[114]. Expenses - Research and development expenses for the three months ended September 30, 2024, were $3.5 million, a decrease of 3% compared to $3.6 million for the same period in 2023[97]. - Selling, general and administrative expenses for the three months ended September 30, 2024, totaled $3.7 million, an increase of 27% compared to $2.9 million for the same period in 2023[98]. - Research and development expenses for the nine months ended September 30, 2024, were $12.5 million, an increase of 40% compared to $8.9 million for the same period in 2023[102]. - Selling, general and administrative expenses for the nine months ended September 30, 2024, totaled $11.1 million, an increase of 23% compared to $9.0 million for the same period in 2023[104]. - Total other expense for the three months ended September 30, 2024, was approximately $0.6 million, a decrease of 25% compared to $0.8 million for the same period in 2023[99]. - Reacquisition of license rights for the nine months ended September 30, 2024, totaled $4.9 million, compared to no expense for the same period in 2023[105]. Cash and Working Capital - Eyenovia's working capital deficit was approximately $4.1 million as of September 30, 2024[87]. - As of September 30, 2024, the company had cash and cash equivalents of $7.2 million and a working capital deficit of $4.1 million[110]. - The company has commitments to pay $5.7 million for accounts payable and accrued expenses, $0.6 million for operating lease commitments, and $10.1 million for notes payable within the next twelve months[117]. Product Development and Sales - Eyenovia's first commercial sale of FDA-approved products occurred on August 3, 2023, with a targeted launch and the onboarding of ten sales representatives through September 30, 2024[88]. - The Optejet device demonstrated a 98% success rate in drug delivery upon the first attempt, compared to approximately 50% for traditional eye drops[73]. - Eyenovia entered into a license agreement with Formosa for exclusive U.S. rights to a novel formulation of clobetasol propionate ophthalmic suspension, with an upfront payment of $2.0 million[80]. - The FDA approved the use of Mydcombi, the only fixed combination of leading mydriatic agents in the U.S., which began commercialization in August 2023[78]. - The company is developing EYEN-520 in collaboration with Senju, targeting chronic dry eye disease, with plans for a Phase 2b study completion in 2025[82]. - Eyenovia has expanded its manufacturing capabilities with new facilities in Reno, Nevada, and Redwood City, California, approved by the FDA for production[76]. - The company is in discussions with manufacturers of existing ophthalmic medications to explore development opportunities using Optejet technology[79]. Geopolitical and Accounting Considerations - The ongoing geopolitical conflicts, including the war between Russia and Ukraine, may impact material costs, potentially affecting the company's operations and financial results[119]. - There are no off-balance sheet arrangements that could materially affect the company's financial conditions or results of operations[120]. - The company prepares its financial statements in accordance with U.S. GAAP, which requires management to make estimates that could materially impact reported financial results[121]. - The company considers certain accounting estimates critical if they involve highly uncertain assumptions that could significantly affect financial conditions or results of operations[122].

Clinical Trials and Product Development - Advanced Phase 3 CHAPERONE study of MicroPine for pediatric progressive myopia, with an interim analysis planned this quarter, targeting a market valued at over $3.0 billion annually in the U.S. and China[2] - Commenced manufacture of registration batches of Mydcombi in its second-generation Optejet device, a key step toward FDA approval[3] Product Launches and Commercialization - U.S. launch and commercial availability of clobetasol propionate ophthalmic suspension 0.05%, FDA-approved for post-operative inflammation and pain following ocular surgery[2] - Trained and shipped Mydcombi to 230 new offices from April through September 30, 2024[4] Collaborations and Partnerships - Collaboration agreements with Formosa Pharmaceuticals, Senju Pharmaceutical Co., Ltd., and SGN Nanopharma to develop novel therapeutics for dry eye disease, a $5 billion global addressable market[3] Financial Performance and Expenses - Net loss for Q3 2024 was $7.9 million, or $0.11 per share, compared to a net loss of $7.3 million, or $0.18 per share, in Q3 2023[8] - Selling, general, and administrative expenses increased by 27.3% to $3.7 million in Q3 2024, reflecting the establishment of the company's sales force[9] - Total operating expenses for Q3 2024 were $7.2 million, a 10.6% increase compared to $6.5 million in Q3 2023[10] - Research and Development expenses for September 2024 were $3,471,939, compared to $3,578,113 for September 2023[19] - Selling, General and Administrative expenses for September 2024 were $3,729,091, compared to $2,929,855 for September 2023[19] - Total Operating Expenses for September 2024 were $7,201,030, compared to $6,507,968 for September 2023[19] - Net Loss for September 2024 was $(7,887,853), compared to $(7,338,733) for September 2023[19] - Net Loss Per Share - Basic and Diluted for September 2024 was $(0.11), compared to $(0.18) for September 2023[19] Revenue and Gross Loss - Revenue for September 2024 was $1,625, compared to $1,198 for September 2023[19] - Gross Loss for September 2024 was $(130,897), compared to $(12,218) for September 2023[19] Cash and Equity - Unrestricted cash and cash equivalents as of September 30, 2024, were $7.2 million[10] - Total Stockholders' Equity decreased to $3,719,303 as of September 30, 2024, from $8,999,094 as of December 31, 2023[18] - Total Liabilities and Stockholders' Equity decreased to $22,796,091 as of September 30, 2024, from $28,779,374 as of December 31, 2023[18] Capital and Shares - Raised combined net proceeds of $10.7 million[4] - Shares Outstanding - Basic and Diluted increased to 69,558,325 as of September 30, 2024, from 40,139,697 as of September 30, 2023[19]

NEW YORK, Nov. 07, 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 that the Company will release financial results for the third quarter ended September 30, 2024 on Tuesday, November 12th, 2024, after the markets close. Following the release, Eyenovia management will host a conference call and webcast at 4:30 p.m. ET t ...