Viridian Therapeutics (VRDN) TD Cowen 46th Annual Health Care Conference summary

Recent progress and upcoming milestones

• REVEAL-1 SubQ program for Thyroid Eye Disease (TED) is on track for a Q1 readout, with REVEAL-2 following in Q2, both representing significant phase III milestones.

• Preparations are underway for a commercial launch of the IV veli program, which has Breakthrough Therapy designation, priority review, and a PDUFA date set for June 30th.

• FcRn programs VRDN-006 and VRDN-008 are advancing, with first-in-human data for VRDN-006 showing promising IgG suppression and albumin-sparing; further clinical plans will be guided later this year.

• A new TSHR program was announced, targeting both TED and Graves’ disease, with potential for future expansion.

Clinical data and product differentiation

• Veli demonstrated rapid onset of effect, with most patients showing response after one infusion, and notable resolution of diplopia, differentiating it from competitors.

• Veli requires only five infusions over 12 weeks, compared to eight infusions over 21 weeks for the competitor, offering a shorter, more convenient treatment.

• Breakthrough Therapy and priority review status were granted based on efficacy, safety, and improved treatment paradigm.

• The AE profile for veli is consistent with expectations, and the SubQ elegrobart program aims for similar or improved safety.

Market opportunity and commercialization strategy

• The U.S. TED market includes about 500,000 patients, with 150,000 under physician care and only 7,000 treated annually, indicating low penetration and significant growth potential.

• Reduced treatment burden with veli and future SubQ options is expected to increase patient and physician adoption.

• Commercial launch will target 2,000 core prescribers with under 100 sales reps, leveraging groundwork laid by previous market leaders.

• Chronic TED population is less urgent to treat, but robust data in chronic flaring patients and diplopia resolution may provide a competitive edge.