- $24.7 million in Lumvoa(TM) (veligrotug-vvze) net product revenue with more than 100 patients on therapy at the end of Q3 2026 -

- Elegrobart Biologics License Application (BLA) submission on track for Q1 2027 -

- VRDN-008 phase 1 data disclosure on track for Q4 2026 -

- VRDN-292, a potential best-in-class TSHR inhibitor, expected to initiate a phase 1 clinical trial in patients in Q4 2026 -

- Cash, cash equivalents, and marketable securities of $955.2 million as of September 30, 2026 -

- Company to host webcast today, November 4, at 8:00 a.m. ET -

WALTHAM, Mass.--(BUSINESS WIRE)--November 04, 2026-- 

Viridian Therapeutics, Inc. (Nasdaq: VRDN), a biotechnology company focused on discovering, developing, and commercializing potentially best-in-class medicines for autoimmune and rare diseases, today reported financial results and recent business updates for the third quarter ended September 30, 2026.

"We are highly encouraged by the strength of Lumvoa's early launch in TED, which has exceeded expectations," said Steve Mahoney, President and Chief Executive Officer of Viridian Therapeutics. "These strong early results are a testament to Lumvoa's compelling clinical profile, the extraordinary execution of our Commercial and Medical teams, and the incredible support of our broader organization. We are excited about this early momentum and look forward to building on it as we continue to execute our launch strategy and strive to bring Lumvoa to more patients with TED. Our pipeline also continues to move forward as we advance elegrobart, our subcutaneously administered anti-IGF-1R, toward a planned BLA submission for TED in the first quarter of 2027. In addition, we look forward to several important milestones for the remainder of this year, including sharing clinical data for VRDN-008, development plans for our FcRn portfolio, and initiating a first-in-human clinical trial in patients for our TSHR program VRDN-292."

Recent Business Highlights

THYROID EYE DISEASE

   --  Lumvoa: strong first quarter of launch, as of September 30, 2026: 
 
          --  Lumvoa generated $24.7 million in net product revenue; 
 
          --  More than 100 patients on therapy with Lumvoa; 
 
          --  Significant market access progress made during the quarter; 
 
          --  CMS has assigned Lumvoa a permanent J-code J3242, effective 
             January 1, 2027; and 
 
          --  Continued execution across field sales, medical, market access, 
             and patient services to drive Lumvoa adoption. 
 
 
 
   --  Elegrobart: BLA submission on track for Q1 2027 
 
          --  Viridian expects to submit a BLA to the U.S. FDA for elegrobart 
             in TED in Q1 2027. 
 
          --  Viridian anticipates launching elegrobart, if approved, in a 
             commercially available autoinjector with at-home, subcutaneous Q4W 
             and Q8W dosing. 
 
          --  The Lumvoa Commercial and Medical infrastructure is expected to 
             support a potential elegrobart launch with limited incremental 
             investment. 
 
 

TSHR PROGRAM

   --  VRDN-292: IND on track to initiate a phase 1 clinical trial in patients 
      in Q4 2026 
 
          --  VRDN-292 IND on track to support phase 1 clinical trial 
             initiation in Q4 2026, starting in patients with Graves' disease. 
 
 
          --  VRDN-292 is a potential best-in-class, half-life extended, 
             monoclonal antibody targeting the thyroid-stimulating hormone 
             receptor (TSHR), designed for subcutaneous delivery in an 
             autoinjector with the potential to support extended dosing 
             intervals for patient convenience. 
 
 

FCRN PORTFOLIO

   --  VRDN-006: VRDN-006 is an Fc fragment that inhibits the neonatal Fc 
      receptor (FcRn). In a phase 1 healthy volunteer clinical trial, VRDN-006 
      showed IgG reductions consistent with the FcRn inhibitor class, spared 
      albumin and LDL, and was generally well-tolerated. 
 
   --  VRDN-008: VRDN-008 is a bispecific, half-life extended FcRn inhibitor. 
      In non-human primates, a single, high-dose of VRDN-008 showed a longer 
      half-life and more sustained IgG reduction versus efgartigimod in a 
      head-to-head study. 
 
   --  FcRn update on track for Q4 2026: Viridian expects to announce VRDN-008 
      phase 1 healthy volunteer data and development plans for the FcRn 
      portfolio in Q4 2026. 

Financial Results

   --  Cash Position: Cash, cash equivalents, and marketable securities were 
      $955.2 million as of September 30, 2026. Existing cash and anticipated 
      future commercial revenues from Lumvoa and elegrobart, if approved, are 
      expected to be able to fund Viridian's current business plans through 
      profitability. 
 
   --  Net Product Revenue: Net product revenue for Lumvoa was $24.7 million 
      during the three months ended September 30, 2026. Viridian did not record 
      net product revenue for the same period in 2025. 
 
   --  R&D Expenses: Research and development expenses were $70.1 million 
      during the three months ended September 30, 2026, compared to $86.3 
      million during the three months ended September 30, 2025. The decrease in 
      research and development expenses was driven by reduced expenses related 
      to veligrotug and elegrobart clinical studies, partially offset by 
      additional investment in advancing our TSHR program and FcRn portfolio, 
      as well as increased personnel-related costs as a result of headcount 
      increases. 
 
   --  SG&A Expenses: Selling, general and administrative expenses for the 
      three months ended September 30, 2026 were $57.6 million, compared with 
      $24.3 million for the three months ended September 30, 2025. The increase 
      in selling, general and administrative expenses was driven by increased 
      personnel-related costs and professional services to support commercial 
      activities for Lumvoa and our growing organization. 
 
   --  Net Loss: Net loss for the three months ended September 30, 2026 was 
      $101.2 million, compared with $34.6 million for the same period in 2025. 
 
 
   --  Shares Outstanding: As of September 30, 2026, Viridian had 125,636,093 
      shares of common stock outstanding on an as-converted basis, which 
      included 113,525,222 shares of common stock and an aggregate 12,110,871 
      shares of common stock issuable upon the conversion of 133,191 and 48,463 
      shares of Series A and Series B preferred stock, respectively. 

Conference Call and Webcast Information

Viridian will host a conference call and webcast today, November 4, at 8:00 a.m. ET to discuss third quarter 2026 financial results and recent business updates. The dial-in number for the conference call is +1 833-461-5787 for domestic participants and +1 585-542-9983 for international participants. The conference ID is 599668655.

A live webcast of the conference call can be accessed under "Events & Presentations" on the Investors section of the Viridian website at viridiantherapeutics.com. Following the live webcast, an archived version of the call will also be available on the Viridian website.

Upcoming Investor Conferences

Viridian will participate in the following upcoming investor conferences. Live webcasts of the presentations can be accessed under "Events & Presentations" on the Investors section of the Viridian website at viridiantherapeutics.com. Replays of the webcasts will be available following each event on the Viridian website.

   --  Jefferies Global Healthcare Conference in London: Fireside chat on 
      November 16, 2026, at 11:30 AM GMT in London, UK 
 
   --  UBS Global Biopharma London Conference: Fireside chat on November 17, 
      2026, at 4:40 PM GMT in London, UK 

About Viridian Therapeutics

Viridian Therapeutics is a biotechnology company dedicated to developing better medicines for patients with autoimmune and rare diseases. Utilizing our expertise in antibody discovery and protein engineering, we aim to build on proven science to develop innovative medicines that address unmet needs and improve patient outcomes.

With an immediate focus in thyroid eye disease (TED), we developed Lumvoa(TM), a full IGF-1R antagonist approved by the U.S. FDA for the treatment of thyroid eye disease. We are also advancing elegrobart, a late-stage investigational subcutaneous therapy designed to further address unmet needs in TED and improve patient convenience. Beyond TED, we are advancing a pipeline of potential best-in-class medicines to address multiple serious autoimmune diseases.

Viridian is based in Waltham, Massachusetts. For more information, please visit www.viridiantherapeutics.com. Follow Viridian on LinkedIn and X.

Forward Looking Statements

This press release contains forward-looking statements. These statements may be identified by the use of words such as, but not limited to, "anticipate," "believe," "become," "continue," "could," "design," "estimate," "expect," "intend," "may," "might," "on track," "plan," "potential," "predict," "project," "should," "target," "will," or "would" or other similar terms or expressions that concern our expectations, plans and intentions. Forward-looking statements are neither historical facts nor assurances of future performance. Instead, they are based on our current beliefs, expectations, and assumptions. Forward-looking statements include, without limitation, statements regarding: that the company's current commercial and medical affairs infrastructure will support an elegrobart launch; preclinical development, clinical development, and anticipated commercialization of Viridian's product candidates, including the company's intention to communicate development plan updates for Viridian's FcRn portfolio in Q4 2026 and plans to initiate a phase 1 clinical trial for VRDN-292 in Q4 2026; anticipated data results and timing of their disclosure, including VRDN-008 phase 1 healthy volunteer data expected in Q4 2026;