MeiraGTx(US:MGTX)2024-11-13 13:34Financial Performance - The company reported net losses of $39.3 million for Q3 2024, compared to $44.3 million for Q3 2023, and total net losses of $108.4 million for the nine months ended September 30, 2024, compared to $104.2 million for the same period in 2023[176]. - Total operating expenses for Q3 2024 were $51.0 million, up from $37.9 million in Q3 2023, and for the nine months ended September 30, 2024, total operating expenses were $144.6 million, compared to $105.3 million for the same period in 2023[177]. - The net loss for Q3 2024 was $39.3 million, an improvement of $4.97 million compared to a net loss of $44.3 million in Q3 2023[211]. - The company incurred $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, an increase of $10.9 million compared to no revenue in Q3 2023[207]. - License revenue was $0 for Q3 2024, down from $5.1 million in Q3 2023 due to the termination of the Collaboration Agreement[208]. - Cost of service revenue for Q3 2024 was $12.0 million, attributed to progress in PPQ services under the Asset Purchase Agreement[208]. - General and administrative expenses increased to $12.7 million in Q3 2024 from $10.0 million in Q3 2023, primarily due to higher legal and accounting fees[209]. - Research and development expenses totaled $26.2 million in Q3 2024, a decrease of $1.6 million from $27.9 million in Q3 2023[212]. - Research and development expenses for the nine months ended September 30, 2024, were $95.5 million, an increase of $25.4 million from $70.1 million in the same period of 2023[230]. Cash and Funding - The company had cash, cash equivalents, and restricted cash of $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 $81.2 million, primarily due to a net loss of $108.4 million[239]. - Net cash provided by financing activities was $50.3 million for the nine months ended September 30, 2024, consisting of $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 $100 million to $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 $3.5 million for the three months ended September 30, 2024, compared to a loss of $8.7 million for the same period in 2023, resulting in a change of $12.1 million[216]. - Interest income increased to $1.2 million for the three months ended September 30, 2024, up from $0.5 million in the same period of 2023, reflecting higher interest rates and cash balances[217]. - A 10% unfavorable movement in foreign currency exchange rates could result in an additional foreign currency loss of approximately $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].