Eyenovia(EYEN) - 2024 Q3 - Quarterly Results

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]