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Tuesday, September 10, 2024

Viridfian Positive Topline Results from Veligrotug (VRDN-001) Phase 3 in Thyroid Eye

 Veligrotug (VRDN-001) achieved all primary and secondary endpoints in THRIVE, the largest phase 3 trial conducted to date of an anti-IGF-1R antibody in thyroid eye disease (TED), with a week 15 proptosis responder rate (PRR) of 70% and a placebo-adjusted PRR of 64% (p < 0.0001) -

- All secondary endpoints were highly statistically significant (p < 0.0001), with clinically meaningful patient outcomes, including complete resolution of diplopia in 54% of patients (placebo-adjusted rate of 43%) and reduction of Clinical Activity Score (CAS) to 0 or 1 in 64% of patients (placebo-adjusted reduction of 46%) treated with veligrotug -

- Veligrotug was generally well-tolerated with no treatment-related serious adverse events (SAEs), and a 5.5% placebo-adjusted rate of hearing impairment AEs -

- THRIVE-2 study of veligrotug in patients with chronic TED fully enrolled with topline data readout on track for year-end 2024; BLA submission anticipated in second half of 2025, as planned -

- REVEAL-1 and REVEAL-2, global phase 3 trials of VRDN-003 dosed every four (Q4W) or eight weeks (Q8W), initiated in August; VRDN-003 is a subcutaneous, half-life-extended anti-IGF-1R antibody with the same binding domain as veligrotug -

- Cash, cash equivalents, and short-term investments of $571.4 million as of June 30, 2024; provides cash runway into the second half of 2026, beyond the planned veligrotug BLA submission, expected REVEAL topline data, and multiple anticipated readouts from Viridian’s FcRn inhibitor programs -

- Conference call and webcast to be held today, September 10th at 8:00 a.m. ET -

Viridian will host a conference call today at 8:00 a.m. ET to discuss the THRIVE topline data. The dial-in number for the conference call is (800) 715-9871 for domestic participants and (646) 307-1963 for international participants. The conference ID is 8636908.

A live webcast of the conference call can be accessed through the “Events” page in the Investors section of the Viridian Therapeutics website. Following the live webcast, an archived version of the call will also be available on the website.

https://www.businesswire.com/news/home/20240910052986/en/

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