Viridian Therapeutics(VRDN) - 2025 Q2 - Quarterly Results

Business Highlights and Pipeline Update Viridian highlights progress on its lead TED drug candidates, FcRn inhibitor pipeline, and a Japan licensing deal Veligrotug Program for Thyroid Eye Disease (TED) Veligrotug, Viridian's lead candidate for TED, received FDA Breakthrough Therapy Designation (BTD) and met all Phase 3 trial endpoints - The FDA granted Breakthrough Therapy Designation (BTD) to veligrotug, a status for drug candidates that may offer substantial improvement over existing therapies. This was based on its robust improvement in diplopia and rapid proptosis response[1][7] - Veligrotug successfully met all primary and secondary endpoints in its two pivotal Phase 3 trials, THRIVE (active TED) and THRIVE-2 (chronic TED)[4] - Long-term data from the THRIVE trial showed strong durability, with 70% of patients who responded to proptosis treatment at 15 weeks maintaining that response at 52 weeks, 40 weeks after the last dose[7] - A Biologics License Application (BLA) submission to the U.S. FDA is on track for the second half of 2025, with a potential U.S. commercial launch in 2026[1][7] VRDN-003 Program for Thyroid Eye Disease (TED) VRDN-003, a subcutaneously delivered TED antibody, aims for infrequent self-administration with pivotal data expected 1H 2026 - Topline data from the pivotal clinical trials, REVEAL-1 and REVEAL-2, are expected in the first half of 2026[7] - The company plans to submit a BLA for VRDN-003 by the end of 2026[7] - VRDN-003 is designed for infrequent self-administration at home using a low-volume autoinjector[7] - VRDN-003 has a half-life of 40-50 days, which is 4-5 times longer than veligrotug, potentially allowing for dosing every 4 or 8 weeks (Q4W/Q8W)[14] Japan Licensing Agreement with Kissei Pharmaceutical Viridian entered an exclusive licensing agreement with Kissei Pharmaceutical for veligrotug and VRDN-003 in Japan Kissei Pharmaceutical Licensing Deal Terms | Term | Value | | :--- | :--- | | Upfront Cash Payment | $70 million | | Potential Future Milestones | Up to $315 million | | Royalties on Net Sales | Tiered, ranging from 20s to mid-30s | - Kissei will be responsible for all development, regulatory, and commercialization activities and costs in Japan[7] FcRn Inhibitor Portfolio Viridian advances its FcRn inhibitor portfolio, with key data and IND submissions anticipated in 2025 - VRDN-006: Data from the Phase 1 clinical trial in healthy volunteers, including proof-of-concept IgG reduction, is expected in Q3 2025[7][11] - VRDN-008: An Investigational New Drug (IND) submission is on track for year-end 2025[7][11] - In non-human primate studies, VRDN-008 demonstrated a longer half-life and more sustained IgG reduction compared to efgartigimod[7][16] Expected Upcoming Milestones Viridian outlines key upcoming milestones for its portfolio, including BLA submissions and clinical data readouts - Veligrotug: - BLA submission in 2H 2025 - U.S. commercial launch in 2026 (if approved) - MAA submission in 1H 2026[7] - VRDN-003: - Topline data in 1H 2026[7] - VRDN-006: - Healthy volunteer clinical data in Q3 2025[11] - VRDN-008: - IND submission by year-end 2025[11] Second Quarter 2025 Financial Results Viridian reports Q2 2025 financial results, detailing cash position, operating expenses, and balance sheet Financial Summary Viridian ended Q2 2025 with $563.4 million cash, extending its runway into 2H 2027 Key Financial & Operational Metrics (Q2 2025) | Metric | Value | | :--- | :--- | | Cash, Cash Equivalents & Short-Term Investments | $563.4 million (as of June 30, 2025) | | Cash Runway | Into 2H 2027 | | Q2 2025 R&D Expenses | $86.6 million | | Q2 2025 G&A Expenses | $20.2 million | | Common Stock Outstanding | 100,320,386 shares (as-converted basis) | - The increase in R&D expenses was driven by costs for multiple ongoing Phase 3 trials (veligrotug, VRDN-003) and a Phase 1 trial (VRDN-006)[11] - The increase in G&A expenses was primarily due to preparatory commercial activities for veligrotug and increased professional service and personnel costs[11] Condensed Consolidated Statements of Operations Viridian reported a Q2 2025 net loss of $100.7 million, reflecting increased operating expenses year-over-year Statement of Operations Highlights (Three Months Ended June 30) | Metric (in thousands USD) | 2025 | 2024 | | :--- | :--- | :--- | | Total revenue | $75 | $72 | | Research and development | $86,626 | $56,193 | | General and administrative | $20,216 | $16,066 | | Loss from operations | ($106,767) | ($72,187) | | Net loss | ($100,735) | ($64,993) | | Net loss per share, common | ($1.00) | ($0.77) | Condensed Consolidated Balance Sheets As of June 30, 2025, Viridian's total assets decreased to $582.3 million, primarily due to cash utilization Balance Sheet Highlights (in thousands USD) | Metric | June 30, 2025 | December 31, 2024 | | :--- | :--- | :--- | | Cash, cash equivalents and short-term investments | $563,356 | $717,584 | | Total assets | $582,324 | $742,403 | | Total liabilities | $67,155 | $70,764 | | Total stockholders' equity | $515,169 | $671,639 |