Viridian Therapeutics Updates on Progress and Q1 2024 Financial Results
Viridian Therapeutics, Inc., a biotechnology firm centered on creating advanced treatments for serious and rare diseases, has announced significant progress in its clinical trials and financial results for the first quarter of 2024. Highlighted below are the recent advancements and financial outcomes of the company.
Thyroid Eye Disease (TED) Portfolio Progress
Viridian's lead candidate, VRDN-001, is an anti-insulin-like growth factor-1 receptor (IGF-1R) antibody administered intravenously. The THRIVE phase 3 clinical trial for patients with active TED has successfully completed and exceeded its enrollment goal in March 2024, enrolling 113 patients instead of the targeted 90. The topline data from this trial is anticipated to be available by September 2024. Meanwhile, the THRIVE-2 trial, aimed at patients with chronic TED, is progressing well and is expected to provide topline results by the end of 2024.
To support the Biologics License Application (BLA) for VRDN-001, Viridian is conducting the STRIVE clinical trial, a global study with broad inclusion criteria to gather the necessary safety data. The company plans to file for BLA in the latter half of 2025, conditional on the data, and believes this will also support a marketing authorization application in Europe.
Additionally, VRDN-003, a subcutaneous, half-life-extended version of the anti-IGF-1R antibody, is on track to begin its pivotal program mid-2024 following a positive Type C meeting with the FDA. This candidate is designed for low-volume, infrequent subcutaneous injections, which could potentially offer a best-in-class treatment option for TED.
FcRn Inhibitor Portfolio Developments
Viridian is also advancing its FcRn inhibitor portfolio. VRDN-006, a highly selective anti-FcRn Fc fragment meant for subcutaneous self-administration, is on schedule for an Investigational New Drug (IND) submission by the end of 2024. Furthermore, VRDN-008, a half-life extended FcRn inhibitor, is designed to provide prolonged IgG suppression, and non-human primate data are expected in the second half of 2024. This could potentially position VRDN-008 as a leading subcutaneous treatment option for various autoimmune diseases.
Financial Highlights
As of March 31, 2024, Viridian's cash, cash equivalents, and short-term investments totaled $613.2 million, up from $477.4 million at the end of 2023. The company anticipates that this financial reserve will sustain operations into the second half of 2026.
Research and development (R&D) expenses for the first quarter of 2024 were $40.9 million, a decrease from $50.7 million in the same period in 2023. The reduction in R&D expenses was largely due to a $15 million license fee in the prior year, although this was somewhat offset by increased costs associated with ongoing clinical trials and personnel.
General and administrative (G&A) expenses also saw a decrease, dropping to $15.0 million for the quarter, down from $21.8 million in the previous year. This reduction was attributed to lower severance and share-based compensation costs related to former executives.
Viridian reported a net loss of $48.5 million for the first quarter of 2024, improved from a net loss of $68.2 million in the same period last year. As of March 31, 2024, the company had approximately 83.86 million shares of common stock outstanding on an as-converted basis.
Corporate Overview
Viridian Therapeutics is dedicated to developing best-in-class medicines for rare diseases, leveraging their expertise in antibody discovery and protein engineering. The company is advancing multiple candidates in clinical trials for TED and has a promising FcRn inhibitor portfolio for potential use in autoimmune diseases. Based in Waltham, Massachusetts, Viridian remains focused on meeting key milestones and delivering on its corporate priorities to benefit patients and stakeholders.
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