MeiraGTx(US:MGTX)2024-08-12 11:14Financial Performance - The net loss attributable to ordinary shareholders for Q2 2024 was $48.6 million, or $0.76 per share, compared to a net loss of $29.6 million, or $0.53 per share in Q2 2023[16]. - Total revenue for the three-month period ended June 30, 2024, was $282,000, a decrease from $3,540,000 in the same period of 2023[21]. - Net loss for the three-month period ended June 30, 2024, was $48,620,000, compared to a net loss of $29,581,000 in the same period of 2023[21]. - Basic and diluted net loss per ordinary share for the three-month period ended June 30, 2024, was $0.76, compared to $0.53 in the same period of 2023[21]. - Total operating expenses for the three-month period ended June 30, 2024, were $46,191,000, an increase from $32,325,000 in the same period of 2023[21]. Cash and Assets - As of June 30, 2024, MeiraGTx reported cash and cash equivalents of approximately $101.0 million, down from $130.6 million as of December 31, 2023[11][12]. - Cash and cash equivalents as of June 30, 2024, were $99,974,000, down from $129,566,000 as of December 31, 2023[22]. - Total current assets decreased to $110,774,000 as of June 30, 2024, from $159,622,000 as of December 31, 2023[22]. - Total liabilities as of June 30, 2024, were $186,612,000, slightly down from $188,567,000 as of December 31, 2023[22]. - The accumulated deficit increased to $623,293,000 as of June 30, 2024, from $554,231,000 as of December 31, 2023[22]. Research and Development - Research and development expenses increased to $34.9 million for Q2 2024, compared to $19.9 million for Q2 2023, primarily due to decreased reimbursements from Johnson & Johnson and increased preclinical program costs[14]. - Research and development expenses for the three-month period ended June 30, 2024, were $34,934,000, up 75% from $19,937,000 in the same period of 2023[21]. - MeiraGTx is progressing its pivotal Phase 2 AQUAx2 clinical trial for radiation-induced xerostomia, with potential BLA filing anticipated in 2026[2][4]. - The company anticipates results from the AAV-GAD trial for Parkinson's disease in Q4 2024, which will inform discussions with global regulatory agencies regarding the Phase 3 program[5][11]. - AAV8-RK-AIPL1 received Innovation Passport Designation from the U.K. for the treatment of LCA4, with all 11 treated children showing significant visual acuity improvements[3][7]. - The riboswitch in vivo delivery platform is showing promising data in obesity and metabolic disease, with plans to present updates later this year[9][10]. - MeiraGTx's Phase 1 AQUAx study demonstrated significant improvements in patient-reported outcomes and saliva production with AAV2-hAQP1 treatment, with no serious adverse events reported[1][3]. Funding and Investments - MeiraGTx announced a $50 million offering of 12.5 million ordinary shares at a price of $4.00 per share, led by Sanofi's $30 million investment[1][2]. - The company expects to receive up to $285 million upon the first commercial sales of bota-vec in the U.S. and EU, along with an additional $15 million in milestone payments later in 2024[6][11]. Shareholder Information - The weighted-average number of ordinary shares outstanding increased to 64,376,396 for the three-month period ended June 30, 2024, from 55,349,534 in the same period of 2023[21].