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 ...

NEW YORK, Oct. 16, 2024 (GLOBE NEWSWIRE) -- Eyenovia, Inc. (NASDAQ: EYEN), an ophthalmic technology company, today announced a presentation at the American Academy of Ophthalmology (AAO) 2024 Expo, which is being held October 19-21, in Chicago. The presentation will detail the results of a successful Phase 3 study (CPN-302) of clobetasol propionate suspension 0.05% (APP13007) that led to its approval by the U.S. Food and Drug Administration as a treatment for inflammation and pain following ocular surgery. ...

Shares of Eyenovia, Inc. (EYEN) have been struggling lately and have lost 7.5% over the past week. However, a hammer chart pattern was formed in its last trading session, which could mean that the stock found support with bulls being able to counteract the bears. So, it could witness a trend reversal down the road. While the formation of a hammer pattern is a technical indication of nearing a bottom with potential exhaustion of selling pressure, rising optimism among Wall Street analysts about the future ea ...

NEW YORK, Oct. 01, 2024 (GLOBE NEWSWIRE) -- Eyenovia, Inc. (NASDAQ: EYEN), an ophthalmic technology company, today announced that the Company has commenced manufacturing of registration batches of its FDA-approved mydriasis product, Mydcombi, a key step in the approval process for its state-of-the-art Gen-2 Optejet dispensing platform. Mydcombi will undergo 12-month stability testing and other functional testing in the Gen-2 Optejet device that is consistent with feedback from the Type-C meeting on Eyenovia ...

NEW YORK, Sept. 27, 2024 (GLOBE NEWSWIRE) -- Eyenovia, Inc. (NASDAQ: EYEN) ("Eyenovia" or the "Company"), an ophthalmic technology company with two FDA-approved products and a late-stage asset in development for the treatment of pediatric progressive myopia, today announced it has entered into a securities purchase agreement with a healthcare focused institutional investor for the purchase and sale of 8,695,653 shares of its common stock (or common stock equivalents in lieu thereof) and warrants to purchase ...

NEW YORK, Sept. 26, 2024 (GLOBE NEWSWIRE) -- Eyenovia, Inc. (NASDAQ: EYEN), an ophthalmic technology company, today announced the U.S. launch and commercial availability of clobetasol propionate ophthalmic suspension 0.05% ("Clobetasol"), approved by the FDA for the treatment of post-operative inflammation and pain following ocular surgery. "The commercial launch of Clobetasol represents a significant milestone for our company, and as the first new ophthalmic steroid to be approved in more than 15 years, a ...

NEW YORK, Sept. 05, 2024 (GLOBE NEWSWIRE) -- Eyenovia, Inc. (NASDAQ: EYEN), a commercialstage ophthalmic company with two FDA-approved products and a late-stage asset in development for the treatment of pediatric progressive myopia, today announced that its strategic partner, Taiwan-based Formosa Pharmaceuticals (TWO:6838), was granted a Taiwan Export License for clobetasol propionate ophthalmic suspension 0.05% ("clobetasol propionate") to allow for shipment of commercial product to the U.S. Clobetasol is ...

NEW YORK, Sept. 03, 2024 (GLOBE NEWSWIRE) -- Eyenovia, Inc. (NASDAQ: EYEN), a commercialstage ophthalmic company with two FDA-approved products and a late-stage asset in pediatric progressive myopia, today announced the appointment of experienced finance and accounting executive Andrew Jones as Chief Financial Officer. Mr. Jones brings to the Eyenovia team more than 30 years of diverse finance and accounting leadership experience spanning therapeutics and medical technology/devices, most recently serving as ...