Viridian Therapeutics(VRDN)2024-11-12 12:15Clinical Trials and Drug Development - Reported positive topline phase 3 data for veligrotug in patients with active thyroid eye disease (TED), achieving all primary and secondary endpoints with high statistical significance (p < 0.0001) after five infusions[4] - THRIVE-2 trial completed enrollment with 188 patients, exceeding the target of 159, and topline data expected in December 2024[4] - VRDN-003, a next-generation subcutaneous IGF-1R inhibitor, has two global phase 3 trials (REVEAL-1 and REVEAL-2) initiated in August 2024, with topline data expected in the first half of 2026[6] - VRDN-006 is on track for IND submission by year-end 2024, with proof-of-concept IgG reduction data anticipated in the second half of 2025[7] - VRDN-008 demonstrated a threefold longer half-life compared to efgartigimod in non-human primate studies, with deeper IgG reductions[8] - Biologics License Application (BLA) for veligrotug is anticipated in the second half of 2025, pending data[5] Financial Performance - Net loss for Q3 2024 was 47.7 million for the same period last year[10] - Total revenue for the three months ended September 30, 2024, was 72,000 for the same period in 2023, representing a 19.4% increase[15] - Total operating expenses for the three months ended September 30, 2024, were 51,296,000 in the prior year, reflecting a 62.8% increase[15] - The net loss for the three months ended September 30, 2024, was 47,660,000 for the same period in 2023, indicating a 60.9% increase in losses[15] - The company reported a comprehensive loss of 47,551,000 for the same period in 2023, reflecting a 58.4% increase[15] - The net loss per share, basic and diluted, was (1.09) for the same period in 2023[15] Expenses and Investments - Research and development expenses increased to 30.4 million for Q3 2023, driven by higher clinical trial costs[10] - General and administrative expenses decreased to 20.9 million for Q3 2023, due to reduced personnel-related costs[10] - Research and development expenses for the three months ended September 30, 2024, were 30,385,000 in the prior year, indicating a 128.3% increase[15] Cash and Assets - Cash, cash equivalents, and short-term investments totaled 571.4 million as of June 30, 2024, following a public offering that generated net proceeds of 753,240,000 as of September 30, 2024, from 771,900,000 as of September 30, 2024, compared to 707,496,000 as of September 30, 2024, up from $442,022,000 at the end of 2023, representing a 60.1% rise[16] Shareholder Information - The weighted-average shares used to compute basic and diluted loss per share increased to 66,420,063 for the three months ended September 30, 2024, from 43,654,577 in the same period of 2023[15]