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| Share Name | Share Symbol | Market | Type |
|---|---|---|---|
| Viridian Therapeutics Inc | NASDAQ:VRDN | NASDAQ | Common Stock |
| Price Change | % Change | Share Price | Bid Price | Offer Price | High Price | Low Price | Open Price | Shares Traded | Last Trade | |
|---|---|---|---|---|---|---|---|---|---|---|
| -0.82 | -5.35% | 14.50 | 15.06 | 16.50 | 203 | 08:04:39 |
From Sep 2024 to Mar 2025
- Reported positive topline phase 3 data for veligrotug from THRIVE in patients with active thyroid eye disease (TED); on track to report topline data from THRIVE-2 in chronic patients in December 2024 -
- Initiated two global phase 3 clinical trials of subcutaneous VRDN-003, REVEAL-1 and REVEAL-2 in August, in active and chronic TED, respectively; topline data anticipated in the first half of 2026 -
- New non-human primate (NHP) data for VRDN-008, a next-generation bispecific neonatal Fc receptor (FcRn) inhibitor, demonstrates a potential best-in-class pharmacokinetic (PK) and pharmacodynamic (PD) profile; Investigational New Drug (IND) submission is planned for year-end 2025 and proof-of-concept IgG reduction data in healthy volunteers is anticipated in the second half of 2026 -
- VRDN-006, a Fc fragment inhibitor of FcRn, remains on track for Investigational New Drug (IND) submission by year-end 2024; proof-of-concept IgG reduction data in healthy volunteers anticipated in the second half of 2025 -
- Net proceeds of $243.2 million from public offering in September 2024 extends cash runway into the second half of 2027; cash, cash equivalents, and short-term investments of $753.2 million as of September 30, 2024 -
Viridian Therapeutics, Inc. (NASDAQ: VRDN), a biotechnology company focused on discovering and developing potential best-in-class medicines for serious and rare diseases, today reported recent business highlights and financial results for the third quarter ending September 30, 2024.
“We had another exceedingly strong quarter of execution across our TED and FcRn portfolios,” said Steve Mahoney, Viridian’s President and Chief Executive Officer. “In TED, we reported highly-compelling and positive phase 3 data for veligrotug and eagerly anticipate the readout of THRIVE-2 in December. We also initiated both pivotal phase 3 clinical trials for VRDN-003, our next-generation subcutaneous IGF-1R inhibitor. For our FcRn inhibitor portfolio, we are thrilled today to share VRDN-008 NHP data for the first time, demonstrating a potential best-in-class pharmacokinetic and pharmacodynamic profile for this half-life extended bispecific FcRn inhibitor. Together with our Fc fragment approach with VRDN-006, we believe these programs in our FcRn portfolio will bring differentiated options for patients and each contribute to an exciting pipeline beyond TED. This quarter, we also further strengthened our cash position with a financing that allows us to accelerate our R&D pipeline and extend our cash runway into the second half of 2027.”
RECENT TED PORTFOLIO PROGRESS
Veligrotug is an intravenously delivered anti-insulin-like growth factor-1 receptor (IGF-1R) antibody in phase 3 development for thyroid eye disease.
VRDN-003 is a potential best-in-class, subcutaneous, half-life extended anti-IGF-1R antibody with the same binding domain as veligrotug.
FCRN PORTFOLIO UPDATE WITH NEW VRDN-008 NHP DATA
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.
VRDN-008 is a half-life extended bispecific 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.
FINANCIAL RESULTS
About Viridian Therapeutics
Viridian is a biopharmaceutical company focused on engineering and developing 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). The company is conducting a pivotal program for veligrotug (VRDN-001), including two global phase 3 clinical trials (THRIVE and THRIVE-2), to evaluate its efficacy and safety in patients with active and chronic TED. 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 neonatal Fc receptor (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 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,” “continue,” “could,” “estimate,” “expect,” “intend,” “may,” “might,” “on track,” “plan,” “potential,” “predict,” “project,” “design,” “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 and clinical development of Viridian’s product candidates veligrotug (formerly VRDN-001), VRDN-003, VRDN-006 and VRDN-008; anticipated start dates of studies, including the initiation date of the phase 1 clinical trial for VRDN-006; milestones; timelines; anticipated data results and timing of their disclosure, including topline results; regulatory interactions and anticipated timing of regulatory submissions, including the anticipated IND submissions for VRDN-006 and VRDN-008 and the anticipated BLA submissions for veligrotug and VRDN-003; Viridian’s expectation that its data package will support a BLA submission for veligrotug in the second half of 2025, pending data; Viridian’s expectation that its data package will support a marketing authorization application in Europe for veligrotug; clinical trial designs, including the REVEAL-1 and REVEAL-2, global phase 3 clinical trials for VRDN-003; Viridian’s plans to launch VRDN-003 with a commercially available auto-injector pen, 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; potential dosing regimen for VRDN-008; Viridian’s product candidates potentially being best-in-class; and that Viridian’s cash, cash equivalents and short-term investments will be sufficient to fund its operations into the second half of 2027.
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; 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 and projected cash runway; 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; and those risks set forth under the caption “Risk Factors” in our most recent quarterly report on Form 10-Q filed with the Securities and Exchange Commission (SEC) on August 8, 2024 and other subsequent disclosure documents filed with the SEC. 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
(amounts in thousands, except share and per share data)
(unaudited)
Three Months Ended
September 30,
Nine Months Ended
September 30,
2024
2023
2024
2023
Revenue: Collaboration Revenue - related party$
86
$
72
$
230
$
242
Total revenue
86
72
230
242
Operating Expenses: Research and development
69,158
30,385
166,294
121,208
General and administrative
14,408
20,911
45,499
62,006
Total operating expenses
83,566
51,296
211,793
183,214
Loss from operations
(83,480
)
(51,224
)
(211,563
)
(182,972
)
Other income (expense) Interest and other income
7,795
4,164
23,527
13,029
Interest and other expense
(1,004
)
(600
)
(2,188
)
(931
)
Net loss
(76,689
)
(47,660
)
(190,224
)
(170,874
)
Change in unrealized gain on investments
1,475
109
594
326
Comprehensive loss
$
(75,214
)
$
(47,551
)
$
(189,630
)
$
(170,548
)
Net loss$
(76,689
)
$
(47,660
)
$
(190,224
)
$
(170,874
)
Net loss per share, basic and diluted$
(1.15
)
$
(1.09
)
$
(2.98
)
$
(3.97
)
Weighted-average shares used to compute basic and diluted loss per share
66,420,063
43,654,577
63,800,798
43,057,658
Viridian Therapeutics, Inc.
Selected Financial Information
Condensed Consolidated Balance Sheets
(amounts in thousands)
(unaudited)
September 30,
December 31,
2024
2023
Cash, cash equivalents and short-term investments$
753,240
$
477,370
Other assets
18,660
13,054
Total assets$
771,900
$
490,424
Total liabilities
64,404
48,402
Total stockholders’ equity
707,496
442,022
Total liabilities and stockholders’ equity$
771,900
$
490,424
View source version on businesswire.com: https://www.businesswire.com/news/home/20241112340006/en/
Anabel Chan, 617-458-8725 Vice President, Investor Relations & Communications IR@viridiantherapeutics.com
Louisa Stone, 617-272-4604 Manager, Investor Relations IR@viridiantherapeutics.com
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