MeiraGTx(MGTX)2024-11-13 13:34Financial Performance - The company reported net losses of 44.3 million for Q3 2023, and total net losses of 104.2 million for the same period in 2023[176]. - Total operating expenses for Q3 2024 were 37.9 million in Q3 2023, and for the nine months ended September 30, 2024, total operating expenses were 105.3 million for the same period in 2023[177]. - The net loss for Q3 2024 was 4.97 million compared to a net loss of 81.2 million in cash flows from operations for the nine months ended September 30, 2024, with no positive cash flows generated during the period[235]. - The company expects to incur significant expenses and operating losses for the foreseeable future as it advances preclinical and clinical development[235]. Revenue and Expenses - Service revenue for Q3 2024 was 10.9 million compared to no revenue in Q3 2023[207]. - License revenue was 5.1 million in Q3 2023 due to the termination of the Collaboration Agreement[208]. - Cost of service revenue for Q3 2024 was 12.7 million in Q3 2024 from 26.2 million in Q3 2024, a decrease of 27.9 million in Q3 2023[212]. - Research and development expenses for the nine months ended September 30, 2024, were 25.4 million from 125.0 million as of September 30, 2024, along with 3.3 million in receivables from Johnson & Johnson Innovative Medicine[175]. - The company expects to fund its operating expenses and capital expenditures into Q2 2026 based on current cash and anticipated milestone payments, excluding 285.0 million in potential future milestones under the Asset Purchase Agreement[179]. - The company estimates it can fund its operating expenses into the second quarter of 2026 based on current cash and expected milestone payments[237]. - For the nine months ended September 30, 2024, the company reported a net cash used in operating activities of 108.4 million[239]. - Net cash provided by financing activities was 52.6 million from the issuance of ordinary shares[243]. Clinical and Research Developments - AAV-GAD demonstrated a statistically significant 18-point average improvement in the UPDRS Part 3 "off" medication score at Week 26 in the high dose group (p=0.03)[186]. - AAV-AIPL1 has shown meaningful responses in 11 out of 11 children treated, all of whom gained visual acuity following treatment[187]. - The Phase 2 AQUAx2 clinical trial for AAV2-hAQP1 is ongoing, with alignment gained from the FDA for it to be considered a pivotal trial[189]. - The company expects to continue incurring research and development costs for AAV-hAQP1 and AAV-GAD, among other therapeutic areas[199]. - The riboswitch technology platform is progressing with a focus on obesity and metabolic diseases, with first human studies planned for 2025[191]. Legal and Regulatory Matters - The FDA granted Rare Pediatric Disease Designation to three of the company's inherited retinal disease programs, which may provide eligibility for priority review vouchers valued between 158 million[188]. - The company is not subject to any material legal proceedings[255]. - There were no changes in internal control over financial reporting that materially affected the company during the quarter ended September 30, 2024[253]. Foreign Currency and Interest - Foreign currency gain was 8.7 million for the same period in 2023, resulting in a change of 1.2 million for the three months ended September 30, 2024, up from 7.5 million for the nine months ended September 30, 2024[248]. - The annual interest rate on the company's term loan was 15.35% as of September 30, 2024, with an outstanding balance of $75.0 million[249]. - The company did not hold any foreign currency forward contracts as of September 30, 2024[248].