Viridian Therapeutics(VRDN)

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Viridian Therapeutics(VRDN) - 2025 Q2 - Earnings Call Presentation
2025-08-06 20:00
Corporate Presentation August 2025 Cautionary note regarding forward-looking statements This presentation contains forward-looking statements. 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 an ...
Viridian Therapeutics, Inc. (VRDN) Reports Q2 Loss, Misses Revenue Estimates
ZACKS· 2025-08-06 12:46
Viridian Therapeutics, Inc. (VRDN) came out with a quarterly loss of $1 per share in line with the Zacks Consensus Estimate. This compares to a loss of $1.02 per share a year ago. These figures are adjusted for non-recurring items. A quarter ago, it was expected that this company would post a loss of $0.95 per share when it actually produced a loss of $0.87, delivering a surprise of +8.42%.Over the last four quarters, the company has surpassed consensus EPS estimates two times.Viridian Therapeutics, which b ...
Viridian Therapeutics(VRDN) - 2025 Q2 - Quarterly Report
2025-08-06 11:09
☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended June 30, 2025 or ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-Q (Mark One) For the transition period from to Commission File No. 001-36483 VIRIDIAN THERAPEUTICS, INC. (Exact name of registrant as specified in its charter) (State or other jurisdiction of incorporati ...
Viridian Therapeutics(VRDN) - 2025 Q2 - Quarterly Results
2025-08-06 11:03
Exhibit 99.1 Viridian Therapeutics Highlights Recent Progress and Reports Second Quarter 2025 Financial Results - Robust execution with multiple upcoming near-term milestones, including planned Biologics License Application (BLA) submission for veligrotug on track in 2H 2025 and expected U.S. commercial launch in 2026 - - Breakthrough Therapy Designation (BTD) for veligrotug announced in May 2025, a designation granted by the Food and Drug Administration (FDA) to drug candidates where clinical evidence show ...
Viridian Therapeutics (VRDN) Earnings Call Presentation
2025-06-19 15:28
Thyroid Eye Disease (TED) Portfolio - Veligrotug (Intravenous) - Positive THRIVE and THRIVE-2 topline data in active and chronic TED showed a robust clinical profile[12] - In the THRIVE trial, 70% of patients receiving veligrotug achieved a proptosis response at 15 weeks, compared to 5% on placebo[57] - In the THRIVE trial, 53% of patients receiving veligrotug achieved a proptosis response at 3 weeks, after just 1 infusion[59] - In the THRIVE-2 trial (chronic TED), 56% of patients achieved a proptosis response compared to 8% in the placebo group[78] - Viridian plans to submit the BLA for veligrotug in the second half of 2025 and the EU MAA in the first half of 2026[3, 12] Thyroid Eye Disease (TED) Portfolio - VRDN-003 (Subcutaneous) - REVEAL-1 and REVEAL-2 trials are enrolling and dosing patients, with topline data expected in the first half of 2026[12] - The BLA submission for VRDN-003 is anticipated by year-end 2026[3, 12] - Phase 1 HV Study showed VRDN-003 has an extended half-life of 40–50 days and increases IGF-1 levels ~4-fold[102, 104] FcRn Inhibitor Portfolio - VRDN-006 proof-of-concept Phase 1 clinical trial data is expected in Q3 2025[3, 12] - VRDN-008 is on track for IND submission by year-end 2025[3, 12] - A single dose of VRDN-008 demonstrated a longer half-life and deeper IgG reduction compared to efgartigimod in NHPs[148, 149] Financial - Viridian had $637 million in cash as of March 31, 2025, providing a runway into the second half of 2027[12]
Viridian Therapeutics: The Song Remains The Same
Seeking Alpha· 2025-06-09 22:18
Group 1 - The discussion in the biotech community has focused on profitable buy-write or covered call strategies for selected biotech stocks over recent months [1] - Viridian Therapeutics, Inc. (NASDAQ: VRDN) has been highlighted as a promising clinical-stage biotech company, despite a significant stock price drop of one-third since the last analysis [2] - The investing group, The Biotech Forum, offers a model portfolio featuring 12-20 high upside biotech stocks, along with live chat discussions and weekly market commentary [2] Group 2 - The article emphasizes that the analyst holds a beneficial long position in VRDN shares through various financial instruments [3] - There is a disclaimer regarding past performance not guaranteeing future results, and no specific investment advice is provided [4]
Viridian Therapeutics (VRDN) 2025 Conference Transcript
2025-06-04 12:35
Summary of Viridian Therapeutics (VRDN) 2025 Conference Call Company Overview - **Company**: Viridian Therapeutics (VRDN) - **Event**: Jefferies Global Healthcare Conference - **Date**: June 04, 2025 Key Points Industry and Product Development - Viridian is focused on the treatment of Thyroid Eye Disease (TED) with its lead program involving both intravenous (IV) and subcutaneous (SUBQ) administration methods [2][23] - The company is completing phase three studies and preparing to file with the FDA [2][18] Clinical Trial Results - The main endpoints for the phase three trials include proptosis response (eye bulging), clinical activity score (pain and inflammation), and diplopia (double vision) [4][5] - The results showed significant improvement in both diplopia and proptosis, with a rapid treatment effect observed after just one infusion [6][7] - 70% of patients maintained their response at 40 weeks post-infusion, compared to Amgen's TEPEZZA, which reported a 53% response rate [8][9] Breakthrough Therapy Designation - The FDA granted breakthrough therapy designation based on rapid treatment onset and superior diplopia resolution rates compared to TEPEZZA [3][14] - Viridian's treatment showed a 20% placebo-adjusted complete resolution of diplopia, significantly higher than TEPEZZA's 3% [14][16] Regulatory and Filing Strategy - The company is awaiting the completion of the chronic study follow-up period before filing for approval [18][23] - A priority review could lead to a PDUFA date in 2026 [23][24] Subcutaneous (SUBQ) Program - The SUBQ program is currently enrolling in two phase three studies, with data expected in the first half of 2026 and a BLA filing anticipated by the end of 2026 [27][28] - The SUBQ formulation is designed for self-administration, which could significantly increase patient access and convenience [41][51] Market Dynamics and Competitive Landscape - TEPEZZA, currently the only approved treatment for TED, has seen declining sales due to initial reimbursement challenges and a lengthy treatment regimen [60][64] - Viridian aims to capture market share by offering a more convenient treatment option with fewer infusions (5 vs. 8 for TEPEZZA) and a shorter treatment duration [63][64] Future Opportunities - The company is optimistic about its potential to become a commercial entity in 2026, leveraging its differentiated data and the convenience of its SUBQ administration [73][74] - Viridian is also developing an FcRn program, targeting multiple indications with a focus on IgG suppression, which could further expand its market opportunities [78][79] Conclusion - Viridian Therapeutics is positioned for significant growth with its innovative treatment for TED and ongoing development of its SUBQ program, alongside a promising FcRn initiative. The company is set to capitalize on the current market dynamics and the shortcomings of existing therapies.
Viridian Therapeutics, Inc. (VRDN) Reports Q1 Loss, Lags Revenue Estimates
ZACKS· 2025-05-06 13:15
Core Viewpoint - Viridian Therapeutics reported a quarterly loss of $0.87 per share, which was better than the Zacks Consensus Estimate of a loss of $0.95, indicating an earnings surprise of 8.42% [1] Financial Performance - The company posted revenues of $0.07 million for the quarter ended March 2025, missing the Zacks Consensus Estimate by 55.83%, with no year-over-year revenue growth [2] - Over the last four quarters, Viridian has surpassed consensus EPS estimates two times and topped consensus revenue estimates only once [2] Stock Performance - Viridian Therapeutics shares have declined approximately 31.6% since the beginning of the year, contrasting with the S&P 500's decline of 3.9% [3] - The current Zacks Rank for the stock is 3 (Hold), suggesting it is expected to perform in line with the market in the near future [6] Earnings Outlook - The current consensus EPS estimate for the upcoming quarter is -$0.98 on revenues of $0.16 million, and for the current fiscal year, it is -$4.01 on revenues of $0.55 million [7] - The estimate revisions trend for Viridian is mixed, which could change following the recent earnings report [6] Industry Context - The Medical - Biomedical and Genetics industry, to which Viridian belongs, is currently in the top 31% of over 250 Zacks industries, indicating a favorable outlook compared to lower-ranked industries [8]
Viridian Therapeutics(VRDN) - 2025 Q1 - Quarterly Report
2025-05-06 11:55
Product Development - The company is developing two product candidates for Thyroid Eye Disease (TED): veligrotug for intravenous administration and VRDN-003 for subcutaneous administration, with VRDN-003 designed for at-home self-administration[170][176]. - In phase 1/2 clinical trials, veligrotug showed that 71% of active TED patients were proptosis responders and 54% had complete resolution of diplopia after two infusions[171]. - The THRIVE study for veligrotug enrolled 113 patients, achieving all primary and secondary endpoints with statistical significance (p < 0.0001) and a rapid treatment effect observed in 53% of patients within three weeks[172]. - The company plans to submit a Biologics License Application (BLA) for veligrotug in the second half of 2025 and for VRDN-003 by the end of 2026[172][176]. - VRDN-003 has a prolonged half-life of 40 to 50 days, which is four to five times that of veligrotug, and is currently in pivotal clinical studies[174][176]. - The company is also developing engineered FcRn inhibitors, including VRDN-006 and VRDN-008, targeting a significant commercial market opportunity in autoimmune diseases[177]. - VRDN-006 demonstrated comparable potency to the current standard of care in FcRn inhibition, efgartigimod, while maintaining a similar safety profile[178]. - VRDN-008 showed three times the half-life of efgartigimod and deeper IgG reductions, with ongoing studies to generate additional data[179]. Financial Performance - Collaboration revenue for the three months ended March 31, 2025, was $72,000, unchanged from the same period in 2024[193]. - Research and development expenses increased by $35.9 million, reaching $76.8 million for the three months ended March 31, 2025, compared to $40.9 million in 2024[193]. - General and administrative expenses rose to $17.1 million for the three months ended March 31, 2025, up from $15.0 million in 2024, reflecting a $2.1 million increase[200]. - Other income, net decreased to $7.0 million for the three months ended March 31, 2025, compared to $7.4 million in 2024, primarily due to changes in interest income[200]. - The accumulated deficit reached $1,082.8 million as of March 31, 2025, primarily due to research and development expenses and general administrative costs[202]. - The company anticipates a $22.9 million increase in clinical trial costs and a $4.0 million increase in chemistry, manufacturing, and controls costs for ongoing global phase 3 clinical trials[199]. - Personnel-related costs increased by $3.1 million, driven by headcount growth to support research and development efforts[199]. - The company expects research and development expenses to continue to rise as clinical and nonclinical programs advance[198]. Cash Flow and Financing - The company had $636.6 million in cash, cash equivalents, and short-term investments as of March 31, 2025, expected to fund operations into the second half of 2027[201]. - Net cash used in operating activities was $92.7 million for the three months ended March 31, 2025, primarily due to a net loss of $86.9 million[219]. - Net cash provided by investing activities was $100.1 million during the three months ended March 31, 2025, mainly from net maturities of short-term investments[221]. - Net cash provided by financing activities was $9.2 million during the three months ended March 31, 2025, including proceeds from the September 2022 ATM Agreement[222]. - The Company sold 3,058,751 shares under the September 2022 ATM Agreement at a weighted average price of $22.86 per share, generating approximately $67.7 million in net proceeds[217]. - The January 2024 Public Offering raised approximately $150 million from the sale of 7,142,858 shares at $21.00 per share[216]. - The Company reported a net increase in cash and cash equivalents of $16.6 million for the three months ended March 31, 2025, compared to a decrease of $11.2 million in the same period of 2024[217]. - The Company is required to pay an end-of-term fee equal to 6% of the principal amount of funded Amended Term Loan advances at maturity[215]. - The Hercules Loan and Security Agreement provides access to a term loan of up to $75.0 million, with an initial tranche of $25.0 million drawn[210]. - The Company has access to an increased term loan of up to $150 million, structured in four tranches, with the first tranche of $50 million already partially drawn[212]. - The Amended Term Loan bears an interest rate of 8.95% as of March 31, 2025, with interest payable monthly[213]. Market Environment - The global macroeconomic environment remains uncertain, potentially impacting future operations due to various geopolitical and economic factors[180]. - There were no material changes to market risks in the three months ended March 31, 2025, compared to the previous disclosures[224].
Viridian Therapeutics(VRDN) - 2025 Q1 - Quarterly Results
2025-05-06 11:28
Financial Performance - Total revenue for Q1 2025 remained flat at $72,000 compared to Q1 2024[18] - Net loss for Q1 2025 was $86,912,000, compared to a net loss of $48,542,000 in Q1 2024, representing an increase of 79.2%[18] - Net loss per share for common stock was $0.87 in Q1 2025, up from $0.59 in Q1 2024[18] - The company reported a comprehensive loss of $86,657,000 for Q1 2025, compared to a comprehensive loss of $49,247,000 in Q1 2024[18] Expenses - R&D expenses increased to $76.8 million in Q1 2025, up from $40.9 million in Q1 2024, due to more clinical trials[12] - General and administrative expenses rose to $17.1 million in Q1 2025, compared to $15.0 million in Q1 2024, driven by preparatory commercial activities[12] - Research and development expenses increased by 87.7% to $76,835,000 in Q1 2025 from $40,944,000 in Q1 2024[18] - Total operating expenses rose by 67.8% to $93,938,000 in Q1 2025 from $55,969,000 in Q1 2024[18] Cash and Assets - Strong cash position of $636.6 million as of March 31, 2025, supporting operations into the second half of 2027[2] - Cash, cash equivalents, and short-term investments decreased to $636,633,000 as of March 31, 2025, down from $717,584,000 as of December 31, 2024[20] - Total assets decreased to $660,981,000 as of March 31, 2025, from $742,403,000 as of December 31, 2024[20] - Total stockholders' equity declined to $604,473,000 as of March 31, 2025, from $671,639,000 as of December 31, 2024[20] - Total liabilities decreased to $56,508,000 as of March 31, 2025, from $70,764,000 as of December 31, 2024[20] Clinical Development - Veligrotug BLA submission is on track for the second half of 2025, with a potential U.S. launch in 2026[4] - Anticipated topline data from phase 3 trials REVEAL-1 and REVEAL-2 for VRDN-003 expected in the first half of 2026[5] - VRDN-008 IND submission is on track for year-end 2025, showing longer half-life than efgartigimod[7] - VRDN-006 proof-of-concept data expected in Q3 2025, focusing on IgG reduction[7] Market and Leadership - The market size for myasthenia gravis and chronic inflammatory demyelinating polyneuropathy is projected to approach $10 billion by 2030[6] - Jeff Ajer appointed to the Board of Directors, bringing over 25 years of experience in commercialization for rare diseases[8] Shares - Shares outstanding as of March 31, 2025, totaled 100,258,627, including common and preferred stock[12]