Viridian Therapeutics Updates on Progress and Q2 2024 Financials

Viridian Therapeutics, Inc., a biotechnology firm based in Waltham, Massachusetts, is dedicated to discovering and developing advanced treatments for severe and rare diseases. The company recently disclosed its business updates and financial results for the second quarter ending June 30, 2024.

Steve Mahoney, President and CEO of Viridian, highlighted the company's accomplishments, particularly within its Thyroid Eye Disease (TED) portfolio. Both VRDN-001 phase 3 trials, THRIVE and THRIVE-2, have surpassed enrollment targets. Additionally, VRDN-003 trials, REVEAL-1 and REVEAL-2, are set to commence this month.

In the TED portfolio, the intravenously delivered anti-IGF-1R antibody VRDN-001 has shown notable progress. The THRIVE-2 global phase 3 trial, involving patients with chronic TED, concluded its enrollment in July 2024, with a total of 188 participants, surpassing the target of 159. Approximately 40% of these participants were from the United States. The company expects to release topline data for VRDN-001 from the THRIVE trial in September and from THRIVE-2 by the end of 2024. A Biologics License Application (BLA) submission is anticipated in the second half of 2025, with an eye on European marketing authorization.

The VRDN-003 antibody, designed for subcutaneous administration, is gearing up for its trials. REVEAL-1 and REVEAL-2 are randomized, placebo-controlled global phase 3 trials assessing the efficacy and safety of VRDN-003 in patients with active and chronic TED. The trials will evaluate the primary endpoint of proptosis responder rate, based on a minimum 2 mm improvement in proptosis at week 24, alongside secondary outcomes such as changes in clinical activity score (CAS) and diplopia. Viridian expects topline data from these trials by the first half of 2026, potentially enabling a BLA submission by the end of that year. If approved, VRDN-003 is intended to be launched with a commercially available auto-injector pen.

In the FcRn inhibitor portfolio, VRDN-006, a selective anti-FcRn Fc fragment, is on track for an Investigational New Drug (IND) application submission by the end of 2024. Additionally, VRDN-008, another half-life extended FcRn inhibitor, is expected to provide non-human primate data in the second half of 2024. This data will include pharmacokinetic (PK) and pharmacodynamic (PD) information, highlighting VRDN-008's potential to offer sustained IgG suppression, making it a promising subcutaneous option for patients.

Financially, Viridian reported a robust cash position with $571.4 million in cash, cash equivalents, and short-term investments as of June 30, 2024. This is a slight decrease from $613.2 million at the end of March 2024. The company believes its current financial resources will support operations until the second half of 2026.

Research and development expenses for the quarter increased to $56.2 million from $40.1 million the previous year, driven by the costs associated with ongoing clinical trials and personnel expenses. General and administrative expenses, however, decreased to $16.1 million from $19.3 million, mainly due to reduced share-based compensation. Consequently, the net loss for the quarter widened to $65.0 million compared to $55.1 million for the same period last year. As of June 30, 2024, Viridian had approximately 83,944,478 shares of common stock outstanding, including shares issuable upon conversion of preferred stock.

Viridian Therapeutics continues to harness its expertise in antibody discovery and protein engineering in its mission to develop cutting-edge treatments for patients with serious and rare diseases. The company is advancing several candidates in clinical stages for the treatment of TED and is also developing a novel portfolio of FcRn inhibitors for multiple autoimmune diseases.