MeiraGTx(US:MGTX)2025-11-13 13:17Financial Performance - The company reported net losses of $50.5 million for Q3 2025, compared to $39.3 million for Q3 2024, and $129.3 million for the nine months ended September 30, 2025, compared to $108.4 million for the same period in 2024[145]. - Net loss for the three months ended September 30, 2025, was $50.5 million, an increase of $11.2 million from a net loss of $39.3 million in 2024[196]. - Cash used in operating activities was $93.0 million for the nine months ended September 30, 2025, compared to $81.2 million in 2024, reflecting an increase in net loss from $108.4 million to $129.3 million[226][227]. - The company expects to incur significant expenses and operating losses for the foreseeable future as it advances preclinical and clinical development, necessitating additional capital[221]. Cash and Financing - As of September 30, 2025, the company had cash, cash equivalents, and restricted cash totaling $17.1 million, with an additional $2.8 million in receivables from Johnson & Johnson Innovative Medicine[144]. - As of September 30, 2025, the company had $17.1 million in cash, cash equivalents, and restricted cash, with a net decrease of $89.1 million during the nine months[225]. - Net cash provided by financing activities was $6.9 million for the nine months ended September 30, 2025, compared to $50.3 million in 2024, indicating a significant decrease in financing[229][230]. - The company anticipates needing additional capital to fund operations and may raise funds through equity offerings, debt financing, or strategic collaborations[147]. - The company estimates it can fund operations into the second half of 2027 based on current cash and anticipated payments, excluding potential near-term cash from milestone achievements[223]. Operating Expenses - The total operating expenses for Q3 2025 were $46.5 million, down from $51.0 million in Q3 2024, while for the nine-month periods, expenses were $138.5 million in 2025 compared to $144.6 million in 2024[146]. - Total operating expenses for the three months ended September 30, 2025, were $46.5 million, a decrease of $4.5 million from $50.9 million in 2024[196]. - Total operating expenses for the nine months ended September 30, 2025, were $138.5 million, a decrease of $6.1 million from $144.6 million in 2024[208]. Research and Development - Research and development expenses increased to $32.5 million for the three months ended September 30, 2025, up by $6.3 million from $26.2 million in 2024, primarily due to increased manufacturing costs[203]. - Research and development expenses for the nine months ended September 30, 2025, were $98.8 million, an increase of $3.3 million from $95.5 million in 2024, primarily due to higher costs in the AAV-GAD program and other ocular diseases[216]. - The company expects to incur increased research and development costs, particularly for AAV-hAQP1 and AAV-GAD, with some costs offset by funding from Hologen[184]. Collaborations and Agreements - The company has received approximately $632.2 million from equity securities sales, $75.0 million from debt issuance, and $130.0 million from the Collaboration Agreement with Johnson & Johnson Innovative Medicine[144]. - A strategic collaboration with Hologen Limited includes an upfront cash payment of $200 million and potential additional funding of up to $230 million[154]. - MeiraGTx entered into a strategic collaboration with Lilly, receiving an upfront payment of $75 million and potential milestone payments exceeding $400 million for the development of genetic medicines in ophthalmology[168]. - Hologen has made $28.0 million in payments towards the upfront payment and an additional $22.0 million in Q4 2025[154]. - Hologen has an exclusive option to purchase additional shares in MeiraGTx Manufacturing, potentially increasing its ownership to 40% within 12 months[164]. - The joint venture Hologen Neuro AI Ltd will be funded with a $200 million upfront payment and up to $230 million in additional funding from Hologen for the AAV-GAD program targeting Parkinson's disease[174]. Clinical Developments - AAV2-hAQP1 received Regenerative Medicine Advanced Therapy (RMAT) designation from the FDA, with a Phase 2 study currently enrolling participants[174]. - AAV-GAD for Parkinson's disease has received RMAT designation, with positive data from three clinical studies supporting its development[174]. - The Phase 3 LUMEOS trial for botaretigene sparoparvovec (bota-vec) has received Fast Track and orphan drug designations from the FDA, with potential revenue of up to $285 million upon first commercial sales[176]. - The company is progressing its first riboswitch program for metabolic disease, with IND-enabling discussions ongoing with regulatory agencies[176]. Currency and Interest - Foreign currency loss was $1.6 million for the three months ended September 30, 2025, compared to a gain of $3.5 million in 2024, reflecting a $5.1 million change due to currency fluctuations[204]. - Foreign currency gain was $10.8 million for the nine months ended September 30, 2025, compared to $2.6 million in 2024, reflecting an increase of $8.1 million due to the weakening of the U.S. dollar against the pound sterling and euro[217]. - Interest income decreased to $0.2 million for the three months ended September 30, 2025, down by $1.0 million from $1.2 million in 2024, attributed to lower interest rates and cash balances[205]. - Interest income decreased to $1.5 million for the nine months ended September 30, 2025, down from $3.1 million in 2024, a decline of $1.6 million attributed to lower interest rates and cash balances[219]. - Interest expense for the three months ended September 30, 2025, was $3.1 million, a decrease of $0.3 million from $3.4 million in 2024, primarily due to lower interest rates[206]. - Interest expense decreased to $9.1 million for the nine months ended September 30, 2025, from $9.9 million in 2024, a reduction of $0.7 million due to lower interest rates[220]. - A hypothetical 1% increase in the SOFR would increase annual interest expense by approximately $0.8 million, given the current outstanding balance of $75.0 million[234].