Viridian Therapeutics, Inc. Q1 FY2023 earnings call

• Scott Myers highlighted progress in clinical programs, including VRDN-001 in TED programs with Phase III THRIVE trial ongoing and chronic TED proof-of-concept study fully enrolled.
• Mentioned rapid growth of team with key hires in senior leadership, such as Tony Casciano as Chief Commercial Officer, Dr. Tom Ciulla as Chief Development Officer, etc.
• Discussed subcutaneous programs with plan to select lead candidate by year-end, with Phase I results expected for VRDN-001 and VRDN-003 in Q4 2023.
• Team presented abstracts at medical congresses, including VRDN-003 research.
• Announced partnership with Enable Injections for on-body drug delivery system for preclinical programs.

No detailed product segment financial performance with revenue contribution % provided in the transcript.

• Anticipates top-line results from THRIVE Phase III trial in middle of 2024.
• Expect results from chronic TED proof-of-concept trial in June or July 2023.
• Cash, cash equivalents, and short-term investments sufficient to fund operations into second half of 2025.
• Plans to select subcutaneous lead program by year-end and advance to pivotal Phase II/III trial in mid-2024.
• VRDN-001 Phase I results in healthy volunteers expected in Q4 2023, VRDN-003 plans to file IND in second quarter.

• Uncertainties in trial results due to CRO processes, e.g., needing time to review chronic TED trial data.
• Market competition with TEPEZZA, including integration challenges with Amgen's acquisition of Horizon affecting sales trajectory.
• Risks associated with regulatory and product development uncertainties as outlined in Form 10-Q and 10-K.

Q: Variables leading to chronic data coming out in July versus in the second quarter and TED market opportunity given Horizon's results?

A: Scott Myers discussed overenrollment in chronic trial and Horizon data relevance, stating chronic trial results expected in June/July and Horizon data as positive for chronic TED with large unmet need.

Q: Path forward with 001 subcu to bridge PK and label expectations?

A: Scott Myers discussed separate IV and subcu programs, with THRIVE and THRIVE-2 studies supporting BLA for broad TED label similar to TEPEZZA.

Q: Market opportunity in chronic TED and backlog?

A: Scott Myers and Dr. Thomas Ciulla discussed physician enthusiasm and potential market growth, noting lines of chronic patients and opportunity with 5-dose regimen.

Q: Impact of chronic data on THRIVE-2 protocol and market access?

A: Todd James discussed trial design consideration informed by chronic data and early market access intelligence being too early to determine.

Q: Pricing and clinical data for retreatment?

A: Scott Myers discussed post-approval pricing and label expansion implications, noting potential paradigm shift with treat and retreat or induction maintenance.