Viridian Therapeutics, Inc.: Q1 FY2026 earnings call

What management said about Q1 FY2026, from the documents filed with the SEC on 5 May 2026: press release. Guidance figures: 1 new, 4 kept. The quarter’s numbers.

Key takeaways

Net loss widened year over year: Net loss was $104.9 million, compared with $86.9 million a year earlier. Net loss per share, basic and diluted, common stock, was $(0.90) against $(0.87). Source
PDUFA date set for June 30: The veligrotug BLA is under Priority Review, with a PDUFA target action date of June 30, 2026. Source
REVEAL-1 met primary endpoint: In active TED, both Q4W and Q8W arms reached proptosis responder rates of 54% and 63% versus 18% placebo at week 24, and the primary endpoint was met. Source
REVEAL-2 met primary endpoint: In chronic TED, both Q4W and Q8W arms reached proptosis responder rates of 50% and 54% versus 15% placebo at week 24, and the primary endpoint was met. Source
BLA submission planned for Q1 2027: The company plans to seek approval for both Q4W and Q8W dosing regimens after a BLA submission in Q1 2027. Source
SG&A more than doubled: SG&A was $38.7 million, compared with $17.1 million, driven by preparatory commercial activities for veligrotug and related headcount increases. Source
Cash declined over the quarter: Cash, cash equivalents and marketable securities were $762.2 million at March 31, 2026, compared with $874.7 million at December 31, 2025. Source

“Our team continues its strong execution across our portfolio as we are launch ready ahead of veligrotug’s PDUFA target date.”
Steve Mahoney, President and Chief Executive Officer of Viridian Therapeutics

Guidance

Area	Period	Figure	Against last quarter
Veligrotug regulatory decision Source	June 30, 2026	PDUFA target action date of June 30, 2026	Kept
Elegrobart BLA submission Source	Q1 2027	Q1 2027	New
TSHR program IND submission Source	Q4 2026	Q4 2026	Kept
VRDN-006 development plan Source	2026	Share development plan in 2026	Kept
VRDN-008 phase 1 data Source	2H 2026	2H 2026	Kept

What changed from last quarter

Guidance kept: The veligrotug PDUFA target action date of June 30, 2026 is unchanged from the prior release. Source
New guidance: The company gave a timing for an elegrobart BLA submission, Q1 2027, which the prior release did not include. Source
New: The EMA marketing authorization application for veligrotug was accepted for review in February 2026, after the January 2026 submission reported in the prior release. Source
Ended: The REVEAL-1 and REVEAL-2 topline readouts, which the prior release listed as pending for Q1 and Q2 2026, have been announced. Source

Quarterly results and net loss

Net loss widened year over year: Net loss was $104.9 million, compared with $86.9 million a year earlier. Net loss per share, basic and diluted, common stock, was $(0.90) against $(0.87). Source
Other income offset part of operating loss: Loss from operations was $116.2 million, against $93.9 million. Total other income, net, was $11.3 million, against $7.0 million. Source
Revenue remained minimal: Total revenues were $141 thousand, compared with $72 thousand, and consisted of license revenue and collaboration revenue from related parties. Source

Veligrotug regulatory status

PDUFA date set for June 30: The veligrotug BLA is under Priority Review, with a PDUFA target action date of June 30, 2026. Source
Breakthrough designation and priority review: The company reports that the FDA granted veligrotug Breakthrough Therapy Designation and Priority Review in 2025. Source
EMA review accepted in February: The marketing authorization application to the EMA was submitted in January 2026 and accepted for review in February 2026. Source
Clinical profile across pivotal trials: Management describes veligrotug as showing rapid onset, improvements in proptosis and diplopia, durable responses and general tolerability across pivotal trials after five infusions. Source

“We believe we are well-prepared and well-positioned to deliver a successful launch.”
Steve Mahoney, President and Chief Executive Officer of Viridian Therapeutics

Elegrobart pivotal phase 3 results

REVEAL-1 met primary endpoint: In active TED, both Q4W and Q8W arms reached proptosis responder rates of 54% and 63% versus 18% placebo at week 24, and the primary endpoint was met. Source
REVEAL-2 met primary endpoint: In chronic TED, both Q4W and Q8W arms reached proptosis responder rates of 50% and 54% versus 15% placebo at week 24, and the primary endpoint was met. Source
Tolerability and hearing impairment: Elegrobart was generally well-tolerated in both pivotal trials, with low rates of hearing impairment, according to the company. Source
BLA submission planned for Q1 2027: The company plans to seek approval for both Q4W and Q8W dosing regimens after a BLA submission in Q1 2027. Source
Positioned as at-home autoinjector: The company plans to launch elegrobart as an autoinjector that patients can administer at home, if approved. Source

FcRn and TSHR pipeline

VRDN-006 showed IgG reduction: In a 2025 phase 1 healthy volunteer trial, VRDN-006 showed IgG reductions consistent with the FcRn inhibitor class. Source
VRDN-006 spared albumin and LDL: The company reports that VRDN-006 spared albumin and LDL in the phase 1 trial and was generally well-tolerated. Source
VRDN-008 phase 1 underway: The VRDN-008 IND was accepted by the FDA in January 2026, and a healthy volunteer phase 1 trial is ongoing. Source
VRDN-008 compared with efgartigimod: After 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

“With the positive topline data from REVEAL-1 and REVEAL-2, in active and chronic TED, respectively, we believe that subcutaneous elegrobart has the potential to be the simplest and most convenient treatment for TED.”
Steve Mahoney, President and Chief Executive Officer of Viridian Therapeutics

Operating expenses and drivers

SG&A more than doubled: SG&A was $38.7 million, compared with $17.1 million, driven by preparatory commercial activities for veligrotug and related headcount increases. Source
R&D flat, with manufacturing costs up: R&D was $77.6 million, compared with $76.8 million, with higher manufacturing costs for veligrotug and TSHR spending offset by lower TED clinical trial costs. Source
Total operating expenses rose: Total operating expenses were $116.3 million, compared with $93.9 million in the same period of 2025. Source

Commercial readiness and engagement

Field teams hired and deployed: Field team hiring, including sales, market access and patient services, is complete and ready for launch, according to the company. Source
Commercial supply and distribution in place: Commercial supply, manufacturing, distribution and supply chain infrastructure are established and ready for launch. Source
Veligrotug infrastructure to support elegrobart: The company anticipates that veligrotug commercial and medical affairs infrastructure will support a potential elegrobart launch, if approved. Source

Cash position and share count

Cash declined over the quarter: Cash, cash equivalents and marketable securities were $762.2 million at March 31, 2026, compared with $874.7 million at December 31, 2025. Source
As-converted share count increased: Common shares on an as-converted basis were 116,757,742 at March 31, 2026, up from 116,126,148 at December 31, 2025. Source

Coming up, as management said on 5 May 2026

Veligrotug FDA action date: The FDA target action date for veligrotug is June 30, 2026. Source
Jefferies fireside chat: Management will take part in a fireside chat at the Jefferies Global Health Care Conference on June 4, 2026. Source
Goldman Sachs fireside chat: Management will take part in a fireside chat at the Goldman Sachs 47th Annual Global Healthcare Conference on June 9, 2026. Source
Elegrobart BLA filing: The company plans to submit the elegrobart BLA in Q1 2027. Source
TSHR IND filing: The company plans to submit an IND for the TSHR program in Q4 2026. Source

Figures management reported

Figure	Reported
R&D expense, first quarter 2026 Source	$77.6 million, compared with $76.8 million
REVEAL-1 proptosis responder rate (active TED) Source	54% (Q4W) and 63% (Q8W) versus 18% placebo at week 24
REVEAL-2 proptosis responder rate (chronic TED) Source	50% (Q4W) and 54% (Q8W) versus 15% placebo at week 24
PDUFA target action date (veligrotug) Source	June 30, 2026
EMA marketing application status (veligrotug) Source	Submitted January 2026; accepted for review February 2026

Earlier plans management reported on

Not stated: The prior release gave Q1 and Q2 2026 timing for the REVEAL topline data; the current release reports both readouts as announced.
On track: Management said the company delivered the elegrobart REVEAL topline data and that earlier programs are moving ahead as planned. Source
On track: Management states that the FcRn portfolio is on track for the VRDN-006 development plan in 2026 and VRDN-008 phase 1 healthy volunteer data in 2H 2026. Source
Not stated: The prior release tied commercial preparations to a planned mid-2026 launch; the current release reports field teams and supply as ready but does not restate the launch timing.

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.

As filed with the SEC

Open the filing on EDGAR

Viridian Therapeutics Reports First Quarter 2026 Financial Results and Highlights Recent Progress

PDUFA target action date of June 30, 2026 for veligrotug in thyroid eye disease (TED); organization is launch-ready -
Marketing Authorization Application (MAA) for veligrotug in TED submitted to the European Medicines Agency (EMA) in January 2026 and accepted for review in February 2026 -
Subcutaneous elegrobart showed positive topline data in REVEAL-1 and REVEAL-2 phase 3 clinical trials in active and chronic TED, respectively; Biologics License Application (BLA) submission anticipated in Q1 2027 with the potential to be the first subcutaneous autoinjector treatment for TED -
FcRn portfolio on track to share VRDN-006 development plan in 2026, and for VRDN-008 phase 1 healthy volunteer data 2H 2026 -
Cash, cash equivalents, and short-term investments of $762M as of March 31, 2026 -

WALTHAM, Mass. - (BUSINESS WIRE) - 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 recent business highlights and financial results for the first quarter ended March 31, 2026.

“Our team continues its strong execution across our portfolio as we are launch ready ahead of veligrotug’s PDUFA target date. We delivered positive topline data from both of elegrobart’s pivotal REVEAL phase 3 clinical trials, and earlier programs are moving ahead as planned,” said Steve Mahoney, President and Chief Executive Officer of Viridian Therapeutics. “With veligrotug’s PDUFA target date next month, we have hired and deployed our full field teams, readied commercial supply and supply chain infrastructure, and continue to engage physicians, payers, and key opinion leaders. We believe we are well-prepared and well-positioned to deliver a successful launch. With the positive topline data from REVEAL-1 and REVEAL-2, in active and chronic TED, respectively, we believe that subcutaneous elegrobart has the potential to be the simplest and most convenient treatment for TED.”

Recent Business Highlights

TED PORTFOLIO

Veligrotug: PDUFA target action date of June 30, 2026; ready to launch
The veligrotug BLA is under Priority Review at the U.S. Food and Drug Administration (FDA) with a Prescription Drug User Fee Act (PDUFA) target action date of June 30, 2026. Veligrotug received Breakthrough Therapy Designation and Priority Review from the FDA in 2025.
Field team hiring, including sales, market access, and patient services, are complete and ready for launch. Commercial supply and manufacturing, distribution, and supply chain infrastructure are also established and ready for launch.
Submitted an MAA to the EMA in January 2026, which was accepted for review in February 2026.
Veligrotug was designed to offer a differentiated clinical profile compared to the current approved treatment option. Across pivotal trials in active and chronic TED, following five infusions, veligrotug demonstrated rapid onset of treatment effect, clinically meaningful improvements in proptosis and diplopia, durable responses, and was generally well-tolerated.
Elegrobart (VRDN-003): positive pivotal phase 3 data and potential to be first subcutaneous autoinjector treatment in TED
Announced positive topline data in both REVEAL-1 and REVEAL-2, elegrobart’s two pivotal phase 3 clinical trials for active and chronic TED, respectively.
Elegrobart is the only subcutaneous program to demonstrate positive pivotal phase 3 clinical data in both active and chronic TED.
REVEAL-1 in Active TED: met its primary endpoint with a highly statistically significant treatment effect. Both elegrobart Q4W and Q8W treatment arms showed rapid onset of treatment effect and achieved clinically meaningful 54% and 63% proptosis responder rates, respectively, versus 18% placebo at week 24. The Q4W treatment arm additionally provided meaningful diplopia benefit to patients with active TED.
REVEAL-2 in Chronic TED: met its primary endpoint with a highly statistically significant treatment effect. Both elegrobart Q4W and Q8W treatment arms achieved statistically significant and clinically meaningful 50% and 54% proptosis responder rates, respectively, versus 15% placebo at week 24. The Q4W treatment arm additionally provided meaningful diplopia benefit to patients with chronic TED.
Generally Well-Tolerated: Elegrobart was generally well-tolerated in both pivotal clinical trials, with low rates of hearing impairment.
Viridian plans to submit a BLA to the FDA in Q1 2027 and seek approval for both Q4W and Q8W elegrobart dosing regimens. Viridian plans to launch elegrobart as the first simple and convenient autoinjector that patients can administer at home.
Viridian anticipates that the veligrotug commercial and medical affairs infrastructure will support the potential elegrobart launch, if approved.
TSHR program: IND submission anticipated in Q4 2026
Developing a potential best-in-class, half-life extended, monoclonal anti-thyroid-stimulating hormone receptor (TSHR) antibody, designed for subcutaneous delivery in an autoinjector with the potential to support extended dosing intervals for patient convenience.
Viridian plans to submit an Investigational New Drug (IND) application in Q4 2026.
Viridian expects this program to have clinical potential in TED and Graves’ disease.

FCRN INHIBITOR PORTFOLIO

VRDN-006: development plan expected in 2026
Viridian anticipates sharing development plans for VRDN-006 in 2026.
VRDN-006 showed IgG reductions consistent with the FcRn inhibitor class in a phase 1 healthy volunteer clinical trial in 2025. VRDN-006 also spared albumin and LDL in the phase 1 clinical trial, and was generally well-tolerated.
VRDN-008: phase 1 healthy volunteer clinical trial ongoing; data on track for 2H 2026
VRDN-008 IND was accepted by the FDA in January 2026, and Viridian initiated a phase 1 clinical trial in healthy volunteers which is ongoing. Data is on track for 2H 2026.
VRDN-008 is a bi-specific half-life extended FcRn inhibitor. As previously disclosed, after a single, high-dose head-to-head study in non-human primates, VRDN-008 showed a longer half-life and more sustained IgG reduction versus efgartigimod.

Financial Results

Cash Position: Cash, cash equivalents, and marketable securities were $762.2 million as of March 31, 2026, compared with $874.7 million as of December 31, 2025.
R&D Expenses: Research and development expenses for the three months ended March 31, 2026 were $77.6 million, compared to $76.8 million during the three months ended March 31, 2025. The increase in research and development expenses was driven by increased costs associated with ongoing manufacturing activities to support our preparatory commercial activities for veligrotug, additional investment in advancing our TSHR program, as well as increased personnel-related costs as a result of headcount increases; partially offset by a decrease in clinical trial costs for our TED portfolio.
SG&A Expenses: Selling, general and administrative expenses for the three months ended March 31, 2026 were $38.7 million, compared with $17.1 million for the three months ended March 31, 2025. The increase in selling, general and administrative expenses was driven by preparatory commercial activities for veligrotug, including increased personnel-related costs as a result of headcount increases.
Net Loss: Net loss for the three months ended March 31, 2026 was $104.9 million, compared with $86.9 million for the same period in 2025.
Shares Outstanding: As of March 31, 2026, Viridian had 116,757,742 shares of common stock outstanding on an as-converted basis, which included 102,458,094 shares of common stock and an aggregate 14,299,648 shares of common stock issuable upon the conversion of 134,864 and 79,620 shares of Series A and Series B preferred stock, respectively.

Upcoming Investor Conferences

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

Jefferies Global Health Care Conference: Fireside chat on Thursday, June 4, 2026, at 9:55am ET in New York, NY
Goldman Sachs 47th Annual Global Healthcare Conference: Fireside chat on Tuesday, June 9, 2026, at 4:00pm ET in Miami, FL

About Viridian Therapeutics

Viridian is a biotechnology company focused on discovering, developing, and commercializing potential best-in-class medicines for patients with autoimmune and rare diseases. Viridian’s expertise in antibody discovery and protein engineering enables the development of differentiated therapeutic candidates for validated drug targets and disease-driving mechanisms in autoimmune and rare diseases.

Viridian is advancing multiple late-stage, anti-insulin-like growth factor-1 receptor (IGF-1R) candidates in the clinic for the treatment of patients with thyroid eye disease (TED). The company conducted a pivotal program for veligrotug, including two global phase 3 clinical trials, THRIVE and THRIVE-2, to evaluate its efficacy and safety in patients with active and chronic TED. THRIVE and THRIVE-2 reported positive topline data, meeting their primary endpoints and all secondary endpoints. Viridian is also advancing elegrobart as the potential first subcutaneous autoinjector for the treatment of TED. Viridian is conducting an ongoing pivotal program for elegrobart, including two global phase 3 pivotal clinical trials, REVEAL-1 and REVEAL-2, to evaluate the efficacy and safety of elegrobart in patients with active and chronic TED. REVEAL-1 and REVEAL-2 reported positive topline data, meeting their primary endpoints and multiple secondary endpoints.

In addition to its IGF-1R inhibitor portfolio, Viridian is developing an anti - thyroid-stimulating hormone receptor (TSHR) program designed as a potential therapy for TED and Graves’ disease.

Viridian is also advancing a novel portfolio of neonatal Fc receptor (FcRn) inhibitors, including VRDN-006 and VRDN-008, which have the potential to be developed in multiple 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

Forward-looking statements notice

This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. 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: preclinical development, clinical development, and anticipated commercialization of Viridian’s product candidates veligrotug, elegrobart, VRDN-006, and VRDN-008, including the VRDN-008 phase 1 clinical trial; anticipated data results and timing of their disclosure, including data from the VRDN-008 phase 1 clinical trial; Viridian’s expectations regarding the anticipated timing or likelihood of regulatory submissions and approvals, including the anticipated approval of the BLA and MAA for veligrotug, submission of a BLA for elegrobart in Q1 2027, and submission of an IND for the Company’s TSHR program in Q4 2026; the impact of Breakthrough Therapy Designation, and the impact of Priority Review, including the potential commercial launch of veligrotug, if approved; the potential utility, efficacy, potency, safety, clinical benefits, clinical response, convenience, and number of indications of veligrotug, elegrobart, VRDN-006, and VRDN-008; elegrobart’s potential to be the first subcutaneous therapy for the treatment of TED; the Company’s anticipated development plans for VRDN-006 to be announced in 2026; potential disease indications for the Company’s TSHR program; and Viridian’s product candidates potentially being best-in-class.

Forward-looking statements notice

New risks and uncertainties may emerge from time to time, and it is not possible to predict all risks and uncertainties. No representations or warranties (expressed or implied) are made about the accuracy of any such forward-looking statements. Such forward-looking statements are subject to a number of material risks and uncertainties including but not limited to: potential utility, efficacy, potency, safety, clinical benefits, clinical response, and convenience of Viridian’s product candidates; that results or data from completed or ongoing clinical trials may not be representative of the results of ongoing or future clinical trials; that preliminary data may not be representative of final data; the timing, progress and plans for our ongoing or future research, preclinical, and clinical development programs; changes to trial protocols for ongoing or new clinical trials; expectations and changes regarding the timing for regulatory filings; regulatory interactions; expectations and changes regarding the timing for enrollment and data; uncertainty and potential delays related to clinical drug development; the duration and impact of regulatory delays in our clinical programs; the timing of and our ability to obtain and maintain regulatory approvals for our therapeutic candidates, including as a result of disruptions at the FDA and other agencies caused by shutdowns, funding shortages, and policies pursued by the current U.S. administration; manufacturing risks; competition from other therapies or products; estimates of market size; other matters that could affect the sufficiency of existing cash, cash equivalents, and short-term investments to fund operations; our financial position; our future operating results and financial performance; Viridian’s intellectual property position; the timing of preclinical and clinical trial activities and reporting results from same; that our product candidates may not be commercially successful, if approved; and other risks described from time to time in the “Risk Factors” section of our filings with the Securities and Exchange Commission (SEC), including those described in our most recent Annual Report on Form 10-K or Quarterly Report on Form 10-Q, as applicable, and supplemented from time to time by our Current Reports on Form 8-K. Any forward-looking statement speaks only as of the date on which it was made. Neither the company, nor its affiliates, advisors, or representatives, undertake any obligation to publicly update or revise any forward-looking statement, whether as a result of new information, future events or otherwise, except as required by law. These forward-looking statements should not be relied upon as representing the company’s views as of any date subsequent to the date hereof.

Viridian Therapeutics, Inc.

Condensed Consolidated Statements Of Operations

(In thousands, except share and per share data)

(Unaudited)

	Three Months Ended March 31,
	2026	2025
Revenues:
License revenue	$6	$ -
Collaboration revenue - related parties	135	72
Total revenues	141	72
Operating expenses:
Research and development	77,631	76,835
Selling, general and administrative	38,679	17,103
Total operating expenses	116,310	93,938
Loss from operations	(116,169)	(93,866)
Total other income, net	11,268	6,954
Net loss	$(104,901)	$(86,912)
Net loss allocated to common stock	$(92,026)	$(70,688)
Net loss per share, basic and diluted, common stock	$(0.90)	$(0.87)
Weighted-average common shares outstanding, basic and diluted	102,211,657	81,344,134
Net loss allocated to Series A convertible preferred stock	$(8,095)	$(7,814)
Net loss per share, basic and diluted, Series A convertible preferred stock	$(60.02)	$(57.94)
Weighted-average Series A convertible preferred stock outstanding, basic and diluted	134,864	134,864
Net loss allocated to Series B convertible preferred stock	$(4,779)	$(8,410)
Net loss per share, basic and diluted, Series B convertible preferred stock	$(60.02)	$(57.94)
Weighted-average Series B convertible preferred stock outstanding, basic and diluted	79,620	145,160

Viridian Therapeutics, Inc.

Condensed Consolidated Balance Sheets

(In thousands)

(Unaudited)

	March 31, 2026	December 31, 2025
Cash, cash equivalents and marketable securities	$762,181	$874,652
Other assets	26,836	24,766
Total assets	$789,017	$899,418
Total liabilities	153,009	177,251
Total stockholders’ equity	636,008	722,167
Total liabilities and stockholders’ equity	$789,017	$899,418

Contacts
Greg Rossino grossino@viridiantherapeutics.com
Lisa Lopez llopez@viridiantherapeutics.com
Source: Viridian Therapeutics, Inc.