Form 8-K
8-K — Viridian Therapeutics, Inc.\DE
Accession: 0001193125-26-205010
Filed: 2026-05-05
Period: 2026-05-05
CIK: 0001590750
SIC: 2834 (PHARMACEUTICAL PREPARATIONS)
Item: Results of Operations and Financial Condition
Item: Financial Statements and Exhibits
Documents
8-K — d149508d8k.htm (Primary)
EX-99.1 (d149508dex991.htm)
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8-K
8-K (Primary)
Filename: d149508d8k.htm · Sequence: 1
8-K
Viridian Therapeutics, Inc.\DE false 0001590750 0001590750 2026-05-05 2026-05-05
UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
FORM 8-K
CURRENT REPORT
Pursuant to Section 13 or 15(d)
of the Securities Exchange Act of 1934
Date of Report (Date of earliest event reported): May 5, 2026
VIRIDIAN THERAPEUTICS, INC.
(Exact name of registrant as specified in its charter)
Delaware
001-36483
47-1187261
(State or other jurisdiction
of incorporation)
(Commission
File Number)
(IRS Employer
Identification No.)
221 Crescent Street, Suite 103A
Waltham, MA
02453
(Address of principal executive offices)
(Zip Code)
Registrant’s telephone number, including area code: (617) 272-4600
N/A
(Former name or former address, if changed since last report)
Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions:
☐
Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)
☐
Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)
☐
Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))
☐
Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))
Securities registered pursuant to Section 12(b) of the Act:
Title of each class
Trading
Symbol(s)
Name of each exchange
on which registered
Common Stock, $0.01 par value
VRDN
The Nasdaq Stock Market LLC
Indicate by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (§230.405 of this chapter) or Rule 12b-2 of the Securities Exchange Act of 1934 (§240.12b-2 of this chapter).
Emerging growth company ☐
If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. ☐
Item 2.02
Results of Operations and Financial Condition
On May 5, 2026, Viridian Therapeutics, Inc. issued a press release reporting financial results for the quarter ended March 31, 2026.
The press release is attached hereto as Exhibit 99.1, which is furnished under Item 2.02 of this Current Report on Form 8-K and shall not be deemed to be “filed” for purposes of Section 18 of the Securities Exchange Act of 1934, as amended (the “Exchange Act”), or otherwise subject to the liabilities of that section, nor shall it be deemed incorporated by reference in any filing under the Exchange Act or the Securities Act of 1933, as amended (the “Securities Act”), regardless of any general incorporation language in such filing.
Item 9.01
Financial Statements and Exhibits.
(d) Exhibits.
99.1
Press Release, dated May 5, 2026
104
Cover Page Interactive Data File (embedded within the Inline XBRL document)
SIGNATURES
Pursuant to the requirements of the Securities Exchange Act of 1934, the Registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.
Viridian Therapeutics, Inc.
Date: May 5, 2026
By:
/s/ Stephen Mahoney
Stephen Mahoney
President and Chief Executive Officer
EX-99.1
EX-99.1
Filename: d149508dex991.htm · Sequence: 2
EX-99.1
Exhibit 99.1
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
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.
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
Investors
Greg Rossino
grossino@viridiantherapeutics.com
Media
Lisa Lopez
llopez@viridiantherapeutics.com
Source: Viridian Therapeutics, Inc.
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+ References
Reference 1: http://www.xbrl.org/2003/role/presentationRef
-Publisher SEC
-Name Exchange Act
-Number 240
-Section 12
-Subsection b
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- Definition
Name of the Exchange on which a security is registered.
+ References
Reference 1: http://www.xbrl.org/2003/role/presentationRef
-Publisher SEC
-Name Exchange Act
-Number 240
-Section 12
-Subsection d1-1
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- Definition
Boolean flag that is true when the Form 8-K filing is intended to satisfy the filing obligation of the registrant as soliciting material pursuant to Rule 14a-12 under the Exchange Act.
+ References
Reference 1: http://www.xbrl.org/2003/role/presentationRef
-Publisher SEC
-Name Exchange Act
-Number 240
-Section 14a
-Subsection 12
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- Definition
Trading symbol of an instrument as listed on an exchange.
+ References
No definition available.
+ Details
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- Definition
Boolean flag that is true when the Form 8-K filing is intended to satisfy the filing obligation of the registrant as written communications pursuant to Rule 425 under the Securities Act.
+ References
Reference 1: http://www.xbrl.org/2003/role/presentationRef
-Publisher SEC
-Name Securities Act
-Number 230
-Section 425
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