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Eyenovia(EYEN) - 2024 Q3 - Quarterly Results
EYENEyenovia(EYEN)2024-11-12 21:13

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 3.0billionannuallyintheU.S.andChina[2]−CommencedmanufactureofregistrationbatchesofMydcombiinitssecond−generationOptejetdevice,akeysteptowardFDAapproval[3]ProductLaunchesandCommercialization−U.S.launchandcommercialavailabilityofclobetasolpropionateophthalmicsuspension0.053.0 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 7.9million,or7.9 million, or 0.11 per share, compared to a net loss of 7.3million,or7.3 million, or 0.18 per share, in Q3 2023[8] - Selling, general, and administrative expenses increased by 27.3% to 3.7millioninQ32024,reflectingtheestablishmentofthecompany′ssalesforce[9]−TotaloperatingexpensesforQ32024were3.7 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 6.5millioninQ32023[10]−ResearchandDevelopmentexpensesforSeptember2024were6.5 million in Q3 2023[10] - Research and Development expenses for September 2024 were 3,471,939, compared to 3,578,113forSeptember2023[19]−Selling,GeneralandAdministrativeexpensesforSeptember2024were3,578,113 for September 2023[19] - Selling, General and Administrative expenses for September 2024 were 3,729,091, compared to 2,929,855forSeptember2023[19]−TotalOperatingExpensesforSeptember2024were2,929,855 for September 2023[19] - Total Operating Expenses for September 2024 were 7,201,030, compared to 6,507,968forSeptember2023[19]−NetLossforSeptember2024was6,507,968 for September 2023[19] - Net Loss for September 2024 was (7,887,853), compared to (7,338,733)forSeptember2023[19]−NetLossPerShare−BasicandDilutedforSeptember2024was(7,338,733) for September 2023[19] - Net Loss Per Share - Basic and Diluted for September 2024 was (0.11), compared to (0.18)forSeptember2023[19]RevenueandGrossLoss−RevenueforSeptember2024was(0.18) for September 2023[19] Revenue and Gross Loss - Revenue for September 2024 was 1,625, compared to 1,198forSeptember2023[19]−GrossLossforSeptember2024was1,198 for September 2023[19] - Gross Loss for September 2024 was (130,897), compared to (12,218)forSeptember2023[19]CashandEquity−UnrestrictedcashandcashequivalentsasofSeptember30,2024,were(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 3,719,303asofSeptember30,2024,from3,719,303 as of September 30, 2024, from 8,999,094 as of December 31, 2023[18] - Total Liabilities and Stockholders' Equity decreased to 22,796,091asofSeptember30,2024,from22,796,091 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]