Full Press Release Details
Viridian Therapeutics Reports Third Quarter 2025 Financial Results and Highlights Recent Progress
- Completed a comprehensive set of financing transactions in October 2025, securing access to up to $889 million of potential capital
across equity, royalty, and credit -
- Successful October submission of Biologics License Application (BLA) to the U.S. Food and
Drug Administration (FDA) for veligrotug in thyroid eye disease (TED) and preparing for an anticipated U.S. commercial launch in mid-2026, if approved, under a Priority Review timeline -
- Subcutaneous VRDN-003 topline data readout accelerated to Q1 2026 for REVEAL-1 and narrowed to Q2 2026 for REVEAL-2 for active and chronic TED, respectively; each study exceeded its enrollment target due to strong patient demand -
- Neonatal Fc receptor (FcRn) inhibitor, VRDN-006, showed proof-of-concept IgG reduction and was sparing of albumin and LDL in a phase 1 healthy volunteer clinical trial; half-life extended FcRn inhibitor, VRDN-008, on track
for 2025 Investigational New Drug (IND) filing with healthy volunteer data anticipated in 2H 2026 -
approximately $887.9 million as of October 31, 2025, inclusive of upfront payments received in October from license, royalty, and debt agreements, as well as proceeds from the equity offering -
- The company believes its existing cash, potential near-term milestones from the royalty agreement, and anticipated commercial revenues, if
both veligrotug and VRDN-003 are approved, are expected to fund its current business plans through profitability -
WALTHAM, Mass. - November 5, 2025 - Viridian Therapeutics, Inc. (Nasdaq: VRDN), a biotechnology company focused on discovering, developing, and
commercializing potentially best-in-class medicines for serious and rare diseases, today reported recent business highlights and financial results for the third quarter
ended September 30, 2025.
"The Viridian team continues to deliver strong results, highlighted by the successful submission of our BLA for
veligrotug, completing enrollment in both pivotal clinical trials for VRDN-003, advancing our FcRn programs, and the completion of royalty financing, equity, and credit transactions resulting in a
comprehensive financing package that we believe allows us to reach profitability," said Steve Mahoney, Viridian's President and CEO. "We are laser-focused on commercial readiness to launch veligrotug by mid-2026, if we receive approval under Priority Review. The recent financings, in particular our equity raise and royalty financing, significantly strengthen our balance sheet, putting us in an even stronger
financial position to execute on our vision of building a leading commercial company starting with treatments for TED."
Company Financed to Anticipated Profitability
Preparing for Veligrotug Commercial Launch
Subcutaneous VRDN-003 Topline Readout
Timing Accelerated and Narrowed
FcRn Inhibitor Portfolio Continues to Advance
Upcoming Investor Conferences
participate in the following upcoming investor conferences. Live webcasts of the presentation 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 the conclusion of each event.
About Viridian Therapeutics
Viridian is a biopharmaceutical company focused on discovering, developing, and commercializing potential best-in-class medicines for patients with serious and rare diseases. Viridian's expertise in antibody discovery and protein engineering enables the development of differentiated therapeutic candidates
for previously validated drug targets in commercially established disease areas.
Viridian is advancing multiple candidates in the clinic for the
treatment of patients with thyroid eye disease (TED) and a portfolio of inhibitors to the neonatal Fc receptor (FcRn). In TED, the company is conducting a pivotal program for veligrotug, including two completed global phase 3 clinical trials (THRIVE
and THRIVE-2), to evaluate its efficacy and safety in patients with active and chronic TED. Both THRIVE and THRIVE-2 reported positive topline data, meeting all the
primary and secondary endpoints of each study. Viridian is also advancing VRDN-003 as a potential best-in-class subcutaneous
therapy for the treatment of TED, including two ongoing global phase 3 pivotal clinical trials (REVEAL-1 and REVEAL-2), to evaluate the efficacy and safety of VRDN-003 in patients with active and chronic TED.
In addition to its TED portfolio, Viridian is advancing a novel
portfolio of FcRn inhibitors, including VRDN-006 and VRDN-008, which has 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
is an intravenously delivered, anti-insulin-like growth factor-1 receptor (IGF-1R) antibody in phase 3 development for thyroid eye disease, with the potential to be the
IV treatment-of-choice for active and chronic TED patients. Based on clinical data to date, veligrotug has demonstrated robust clinical activity and was generally
Both pivotal phase 3 clinical trials, THRIVE and THRIVE-2, reported positive topline data,
meeting all the primary and secondary endpoints of each study. In these studies, veligrotug demonstrated a rapid onset of clinical benefit and statistically significant and clinically meaningful effect on multiple diplopia endpoints. This is the
first data set from a global phase 3 clinical trial in chronic TED patients to demonstrate statistically significant diplopia response and resolution.
VRDN-003 is a subcutaneously delivered, half-life extended, potential best-in-class anti-IGF-1R antibody. VRDN-003 has the same binding domain as veligrotug
and was engineered to have a longer half-life. In a phase 1 healthy volunteer clinical trial, VRDN-003 showed a half-life of 40-50 days,
4-5x that of veligrotug. Pharmacokinetics modeling predicted that VRDN-003 exposure levels after Q4W and Q8W dosing achieve the range of veligrotug exposures that showed
robust clinical activity in a two-infusion phase 2 clinical trial in TED. Viridian is conducting a pivotal program for VRDN-003, including two phase 3 clinical trials
assessing VRDN-003 dosed Q4W and Q8W in active and chronic TED, REVEAL-1 and REVEAL-2, respectively.
About VRDN-006 and VRDN-008
VRDN-006 is a highly selective Fc fragment which inhibits FcRn and is designed to be a convenient subcutaneous and
self-administered option for patients. Viridian is studying VRDN-006 in a first-in-human phase 1 clinical trial in healthy
VRDN-008 is a half-life extended FcRn inhibitor comprising an Fc fragment and an albumin-binding
domain designed to prolong IgG suppression and provide a potentially best-in-class subcutaneous option for patients. VRDN-008
showed a longer half-life than efgartigimod and led to a more sustained IgG reduction after a single, high dose head-to-head study in
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,
VRDN-003, VRDN-006, and VRDN-008; anticipated data results and timing of their disclosure, including VRDN-003 topline data from the REVEAL-1 and REVEAL-2 trials; Viridian's expectations regarding the anticipated timing or
likelihood of regulatory submissions and approvals, including the anticipated approval of the BLA for veligrotug, BLA submission for VRDN-003, MAA submission for veligrotug, and IND submission for VRDN-008; the impact of Breakthrough Therapy Designation, including eligibility for Priority Review, and the impact of Priority Review, including the potential commercial launch of veligrotug in mid-2026, if approved; the potential utility, efficacy, potency, safety, clinical benefits, clinical response, convenience, and number of indications of veligrotug, VRDN-003, VRDN-006, and VRDN-008; veligrotug's potential to be the IV treatment-of-choice for
active and chronic TED; potential market sizes and market opportunities, including for veligrotug; Viridian's product candidates potentially being best-in-class;
Viridian's expectations regarding the potential commercialization of veligrotug and VRDN-003, if approved; Viridian's ability to receive milestone payments pursuant to its agreement with DRI
Healthcare; and that Viridian's cash, potential near-term milestones from the royalty agreement and anticipated commercial revenues, if veligrotug and VRDN-003 are approved, will be sufficient to fund
its business plans through profitability.
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, including as a result of a prolonged government shutdown; the timing of and our ability to obtain and maintain regulatory approvals for our
therapeutic candidates, including as a result of a prolonged government shutdown; 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.
CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS AND COMPREHENSIVE LOSS
(In thousands, except share and per share data)
| Three Months Ended | Nine Months Ended | |||||||||||||||
| September 30, | September 30, | |||||||||||||||
| 2025 | 2024 | 2025 | 2024 | |||||||||||||
| Revenue: | ||||||||||||||||
| License revenue | $ | 70,000 | $ | - | $ | 70,000 | $ | - | ||||||||
| Collaboration revenue - related party | 570 | 86 | 717 | 230 | ||||||||||||
| Total revenue | 70,570 | 86 | 70,717 | 230 | ||||||||||||
| Operating expenses: | ||||||||||||||||
| Research and development | 86,261 | 69,158 | 249,721 | 166,294 | ||||||||||||
| General and administrative | 24,322 | 14,408 | 61,642 | 45,499 | ||||||||||||
| Total operating expenses | 110,583 | 83,566 | 311,363 | 211,793 | ||||||||||||
| Loss from operations | (40,013 | ) | (83,480 | ) | (240,646 | ) | (211,563 | ) | ||||||||
| Total other income (expense), net | 5,414 | 6,791 | 18,400 | 21,339 | ||||||||||||
| Net loss | $ | (34,599 | ) | $ | (76,689 | ) | $ | (222,246 | ) | $ | (190,224 | ) | ||||
| Net loss allocated to common stock | $ | (28,169 | ) | $ | (58,763 | ) | $ | (180,856 | ) | $ | (144,098 | ) | ||||
| Net loss per share, basic and diluted, common stock | $ | (0.34 | ) | $ | (0.88 | ) | $ | (2.22 | ) | $ | (2.26 | ) | ||||
| Weighted-average common shares outstanding, basic and diluted | 81,784,499 | 66,420,063 | 81,576,987 | 63,800,798 | ||||||||||||
| Net loss allocated to Series A convertible preferred stock | $ | (3,097 | ) | $ | (9,243 | ) | $ | (19,934 | ) | $ | (24,328 | ) | ||||
| Net loss per share, basic and diluted, Series A convertible preferred stock | $ | (22.96 | ) | $ | (58.99 | ) | $ | (147.81 | ) | $ | (150.57 | ) | ||||
| Weighted-average Series A convertible preferred stock outstanding, basic and diluted | 134,864 | 156,699 | 134,864 | 161,568 | ||||||||||||
| Net loss allocated to Series B convertible preferred stock | $ | (3,333 | ) | $ | (8,683 | ) | $ | (21,456 | ) | $ | (21,798 | ) | ||||
| Net loss per share, basic and diluted, Series B convertible preferred stock | $ | (22.96 | ) | $ | (58.98 | ) | $ | (147.81 | ) | $ | (150.58 | ) | ||||
| Weighted-average Series B convertible preferred stock outstanding, basic and diluted | 145,160 | 147,218 | 145,160 | 144,763 |
Viridian Therapeutics, Inc.
Condensed Consolidated Balance Sheets
| September 30, | December 31, | |||||||
| 2025 | 2024 | |||||||
| Cash, cash equivalents and short-term investments | $ | 490,901 | $ | 717,584 | ||||
| Unbilled revenue | 70,000 | - | ||||||
| Other assets | 16,237 | 24,819 | ||||||
| Total assets | $ | 577,138 | $ | 742,403 | ||||
| Total liabilities | 74,168 | 70,764 | ||||||
| Total stockholders' equity | 502,970 | 671,639 | ||||||
| Total liabilities and stockholders' equity | $ | 577,138 | $ | 742,403 |
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Source: Viridian Therapeutics, Inc.