Viridian Therapeutics, Inc.\DE Q4 FY2021 earnings call

Jonathan Violin provided an overview of the business, noting 2021 was transformational with over 50 FTEs, two clinical stage programs, and a growing pipeline. He discussed the pipeline, including VRDN-001 (monoclonal antibody for TED with Phase 1/2 trial ongoing) and VRDN-002 (next-gen IGF-1R targeted program with IND application accepted). Kristian Humer reviewed financial results, noting research and development and general and administrative expenses increased, but cash position was sufficient to fund operations into 2024.

Research and development expenses were $22.4 million for the quarter ended December 31, 2021 and $56.9 million for the year ended December 31, 2021. General and administrative expenses were $6.9 million for the quarter ended December 31, 2021 and $25.8 million for the year ended December 31, 2021. Net loss was $28.9 million for the fourth quarter of 2021 and $79.4 million for the year ended December 31, 2021. As of December 31, 2021, Viridian had approximately $197 million in cash, cash equivalents and short-term investments.

VRDN-001 Phase 1/2 proof-of-concept clinical trial data expected in the second quarter. VRDN-002 first-in-human Phase 1 clinical trial data expected midyear. Current cash, cash equivalents, and short-term investments sufficient to fund operations into 2024.

Forward-looking statements are subject to risks and uncertainties that could cause actual results to differ. Factors discussed in Form 10-K and other periodic reports filed with the SEC.

Q: In the context of IV formulations, what are differentiations for 001 relative to Tepezza?

A: Less frequent IV infusions, lower dose, potentially better safety/tolerability.

Q: Is 002 data gating for 001?

A: No, 001 will move forward regardless.

Q: Regionally where is 001 study enrolling?

A: North America, U.S. and Canada.

Q: Competitive timelines for subcu formulations?

A: Horizon's subcu plans noted, but Viridian's 002 has half-life extension for better PK.

Q: When to expect 001 proof-of-concept data?

A: Second quarter, more likely second half.

Q: Potential learnings from 001 to 002?

A: Similar mechanism of action gives confidence 002 may perform well.

Q: Path to market for subcu 001?

A: Stay tuned, but high affinity and half-life extension are factors.

Q: Predictiveness of preclinical PK data?

A: Preclinical data for 001 and Tepezza similar, 002's half-life extension validated.

Q: Value of IV market?

A: IV market is established and growing, subcu is potential but IV not going away.

Q: Timing of 001 12-week data?

A: Depends on timing and medical meeting plans.

Q: Path to market for subcu 001 and 002?

A: 001 and 002 moving forward in parallel, stay tuned for details.