Viridian Therapeutics, Inc.: Q2 FY2026 earnings call
What management said about Q2 FY2026, from the documents filed with the SEC on 6 August 2026: press release. Guidance figures: 4 kept. The quarter’s numbers.
Key takeaways
- Lumvoa approved ahead of PDUFA: The FDA approved Lumvoa for TED on June 26, 2026, ahead of the June 30 PDUFA target date, and the product was launched in the U.S. immediately. Source
- First Lumvoa doses given in July: The first Lumvoa doses were administered in July, and patient enrollment forms to date indicate demand, according to management. Source
- Elegrobart filing still set for Q1 2027: The company continues toward a planned elegrobart BLA submission and reported positive topline results from the REVEAL-1 and REVEAL-2 pivotal trials. Source
- R&D spend fell year on year: R&D expenses were $71.6 million, down from $86.6 million a year earlier and $77.6 million in Q1 2026, as veligrotug and elegrobart study costs declined. Source
- SG&A rose on Lumvoa build-out: SG&A expenses were $55.0 million, against $20.2 million a year earlier, driven by personnel costs and commercial infrastructure for Lumvoa. Source
- Cash rose to $981.5 million: Cash, cash equivalents and marketable securities were $981.5 million at June 30, 2026, up from $762.2 million at March 31, 2026 and $874.7 million at December 31, 2025. Source
“We are very encouraged by the early indications from our recent launch of Lumvoa as we start a new chapter for Viridian as a commercial-stage company,”
Steve Mahoney, President and Chief Executive Officer of Viridian Therapeutics
Guidance
| Area | Period | Figure | Against last quarter |
|---|---|---|---|
| Elegrobart regulatory filing Source | Q1 2027 | Q1 2027 | Kept |
| TSHR program IND filing Source | Q4 2026 | Q4 2026 | Kept |
| VRDN-008 phase 1 data Source | 2H 2026 | 2H 2026 | Kept |
| VRDN-006 development plan Source | 2026 | 2026 | Kept |
What changed from last quarter
- New: Lumvoa (veligrotug-vvze) was approved by the FDA for TED on June 26, 2026, ahead of the June 30 PDUFA target date, and launched in the U.S. immediately. Source
- New: The company completed convertible debt and equity financing in May 2026 with gross proceeds of $394 million. Source
- Guidance kept: The elegrobart BLA submission timing of Q1 2027 was kept from the prior quarter. Source
Lumvoa launch and early demand
- Lumvoa approved ahead of PDUFA: The FDA approved Lumvoa for TED on June 26, 2026, ahead of the June 30 PDUFA target date, and the product was launched in the U.S. immediately. Source
- Physician engagement reached 95 percent: As of July 31, 2026, the field sales team had engaged 95% of the 2,000 core prescribing physicians, with early feedback reported as positive. Source
- First Lumvoa doses given in July: The first Lumvoa doses were administered in July, and patient enrollment forms to date indicate demand, according to management. Source
- Payer coverage efforts on track: Market access efforts to gain payer coverage were reported as on track as of the release date. Source
- ViridianCares patient support activated: The ViridianCares patient support program was activated at approval to help patients, physician offices and infusion centers with insurance coverage and treatment navigation. Source
Elegrobart filing and launch plans
- Elegrobart filing still set for Q1 2027: The company continues toward a planned elegrobart BLA submission and reported positive topline results from the REVEAL-1 and REVEAL-2 pivotal trials. Source
- Elegrobart as home autoinjector: Elegrobart is described as potentially the first low-volume subcutaneous autoinjector for TED that patients can self-administer at home, if approved. Source
- Launch to use existing infrastructure: Management anticipates that current commercial and medical affairs infrastructure will support and accelerate a potential elegrobart launch with limited incremental investment. Source
- Week 24 proptosis reductions reported: At week 24 in both REVEAL trials, Q4W and Q8W elegrobart reduced proptosis rapidly and robustly, and Q4W also showed diplopia benefit in active TED. Source
“Our team’s focus on execution continues in the commercial setting and we are happy with the early launch feedback from physicians and patients”
Steve Mahoney, President and Chief Executive Officer of Viridian Therapeutics
FcRn and TSHR pipeline progress
- VRDN-008 phase 1 trial ongoing: The VRDN-008 phase 1 healthy volunteer trial is ongoing, and VRDN-008 is a bi-specific, half-life extended FcRn inhibitor. Source
- VRDN-008 longer half-life than efgartigimod: In a single high-dose head-to-head study in non-human primates, VRDN-008 showed a longer half-life and more sustained IgG reduction than efgartigimod. Source
- VRDN-006 phase 1 results recapped: VRDN-006 showed IgG reductions consistent with the FcRn class, spared albumin and LDL, and was generally well-tolerated in a phase 1 healthy volunteer trial. Source
- TSHR antibody designed for autoinjector: The TSHR antibody is half-life extended and designed for subcutaneous delivery in an autoinjector, with potential for extended dosing intervals. Source
Revenue and operating costs
- Revenue remained minimal: Total revenues were $284 thousand, made up of $233 thousand license revenue and $51 thousand related-party collaboration revenue, against $75 thousand a year earlier. Source
- R&D spend fell year on year: R&D expenses were $71.6 million, down from $86.6 million a year earlier and $77.6 million in Q1 2026, as veligrotug and elegrobart study costs declined. Source
- SG&A rose on Lumvoa build-out: SG&A expenses were $55.0 million, against $20.2 million a year earlier, driven by personnel costs and commercial infrastructure for Lumvoa. Source
- Net loss and per-share loss rose: Net loss was $127.1 million, or $1.05 per share, compared with $100.7 million, or $1.00 per share, a year earlier. Source
- Other income moved to expense: Total other income (expense), net was $(851) thousand, compared with $6,032 thousand of income a year earlier. Source
“we are well positioned to continue executing across our commercial and development priorities.”
Steve Mahoney, President and Chief Executive Officer of Viridian Therapeutics
Cash position and balance sheet
- Cash rose to $981.5 million: Cash, cash equivalents and marketable securities were $981.5 million at June 30, 2026, up from $762.2 million at March 31, 2026 and $874.7 million at December 31, 2025. Source
- Liabilities rose from year start: Total liabilities were $435.1 million at June 30, 2026, against $177.3 million at December 31, 2025, and total stockholders' equity was $662.1 million. Source
- Other receivable of $75 million: The balance sheet shows an other receivable of $75.0 million at June 30, 2026; the documents do not describe it. Source
- Funding expected through profitability: Management said existing cash and anticipated future commercial revenues from Lumvoa and elegrobart, if approved, are expected to fund current business plans through profitability. Source
Share count and conversions
- As-converted shares rose to 125.3 million: Shares on an as-converted basis were 125,349,092 at June 30, 2026, up from 116,757,742 at March 31, 2026. Source
- Preferred stock convertible into common: Preferred stock of 181,654 shares was convertible into 12,110,874 common shares at June 30, 2026. Source
- Weighted-average common shares increased: Weighted-average common shares, basic and diluted, were 107,884,104 in the quarter, up from 81,593,463 a year earlier. Source
Coming up, as management said on 6 August 2026
- Elegrobart BLA submission: Management plans to submit the elegrobart BLA to the FDA in Q1 2027. Source
- TSHR program IND filing: Management plans to submit an IND application for the TSHR program in Q4 2026. Source
- VRDN-008 phase 1 data readout: Phase 1 healthy volunteer data for VRDN-008 are expected in the second half of 2026. Source
- VRDN-006 development plan: Management anticipates sharing development plans for VRDN-006 during 2026. Source
- Elegrobart launch preparation: Current commercial and medical affairs infrastructure is expected to support a potential elegrobart launch with limited added investment. Source
Figures management reported
| Figure | Reported |
|---|---|
| R&D expenses Source | $71.6 million, three months ended June 30, 2026 |
| FDA approval Source | Lumvoa (veligrotug-vvze) approved for TED, June 26, 2026 |
| BLA submission milestone Source | Elegrobart BLA planned for Q1 2027 |
| Pipeline readout Source | VRDN-008 phase 1 healthy volunteer data expected 2H 2026 |
| Product sales by drug Source | Not reported; total revenues $284 thousand |
Earlier plans management reported on
- Ahead: The FDA approval came on June 26, 2026, ahead of the target PDUFA date. Source
- On track: Management said the elegrobart BLA submission is on track for Q1 2027. Source
- On track: Management said data from the VRDN-008 phase 1 trial remain on track for the second half of 2026. Source
- On track: Management said it is on track to deliver clinical development milestones for the FcRn and TSHR programs in the second half of 2026. Source
- On track: Management said efforts to gain payer coverage for Lumvoa are on track. Source
Other quarters
Summarised with AI from the documents the company filed with the SEC. Every point is checked against the filing before it is shown: management’s own words word for word, figures against the line or table row they come from. A point that fails the check is left out. Source opens the filing at that line.