REGENXBIO(US:RGNX)2025-11-06 12:38Financial Position - Cash, cash equivalents, and marketable securities were $302.0 million as of September 30, 2025, up from $244.9 million as of December 31, 2024, primarily due to a $110.0 million upfront payment from the Nippon Shinyaku partnership and $144.5 million in net proceeds from royalty monetization[12] - Total current assets increased to $331,967,000 as of September 30, 2025, compared to $278,001,000 at December 31, 2024, reflecting a growth of 19.3%[23] - Total liabilities increased to $363,751,000 as of September 30, 2025, from $206,338,000 at December 31, 2024, representing a substantial increase of 76.2%[23] - The company’s total stockholders' equity decreased to $161,452,000 as of September 30, 2025, down from $259,651,000 at December 31, 2024, indicating a decline of 37.8%[23] - The company’s cash and cash equivalents increased to $58,802,000 as of September 30, 2025, compared to $57,526,000 at December 31, 2024, showing a slight increase of 2.2%[23] Revenue Performance - Revenues for the third quarter of 2025 were $29.7 million, an increase of 22.8% compared to $24.2 million for the same period in 2024, driven by $5.9 million of development service revenue under the Nippon Shinyaku partnership[13] - Total revenues for the three months ended September 30, 2025, were $29,733,000, an increase from $24,197,000 in the same period of 2024, representing a growth of 22.5%[24] - License and royalty revenue for the nine months ended September 30, 2025, was $129,119,000, significantly higher than $61,172,000 for the same period in 2024, indicating a year-over-year increase of 111.5%[24] Expenses - Research and development expenses rose to $56.1 million in Q3 2025, compared to $54.4 million in Q3 2024, mainly due to increased personnel and manufacturing costs for clemidsogene lanparvovec[14] - General and administrative expenses increased to $20.3 million in Q3 2025 from $19.4 million in Q3 2024, largely due to higher professional services and consulting costs[15] - Research and development expenses for the nine months ended September 30, 2025, totaled $168,688,000, up from $158,142,000 in the same period of 2024, marking a rise of 6.5%[24] - The company reported total operating expenses of $82,144,000 for the three months ended September 30, 2025, a decrease from $86,275,000 in the same period of 2024, representing a reduction of 4.9%[24] Net Loss - The net loss for Q3 2025 was $61.9 million, or $1.20 per share, compared to a net loss of $59.6 million, or $1.17 per share, in Q3 2024[16] - The company reported a net loss of $61,941,000 for the three months ended September 30, 2025, compared to a net loss of $59,597,000 for the same period in 2024, showing an increase in loss of 3.9%[24] Product Development - The RGX-202 program for Duchenne muscular dystrophy is advancing rapidly, with topline results expected in early Q2 2026 and a Biologics License Application (BLA) submission planned for mid-2026[5] - Clemidsogene lanparvovec (RGX-121) is on track to be the first gene therapy for MPS II, with a PDUFA date set for February 8, 2026[6] - Enrollment in pivotal trials for surabgene lomparvovec (sura-vec) has been completed, with topline data expected in Q4 2026, positioning it to be the first approved gene therapy for wet AMD[9] - The pivotal program for sura-vec is supported by durable safety and efficacy data observed in patients with non-proliferative diabetic retinopathy through two years in the Phase II ALTITUDE trial[10] Cash Flow Outlook - REGENXBIO expects its cash position to fund operations into early 2027, excluding potential milestone payments from partners[17]