Viridian Therapeutics(VRDN)

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Viridian Therapeutics: De-Risked Leadership In Thyroid Eye Disease (NASDAQ:VRDN)
Seeking Alpha· 2025-09-26 14:56
I have a B.Tech degree in Mechanical Engineering from a top school in India. For nearly twenty five years, I have worked in the oil and gas sector, primarily in the Middle East. I work at the intersection of engineering, operations, and project management in an industry that does not forgive mistakes - so I have learned to be efficient, careful, and disciplined. These traits inform my investment strategy. For much of my professional career, I have maintained a serious and sustained interest in the U.S. equi ...
Viridian Therapeutics: De-Risked Leadership In Thyroid Eye Disease
Seeking Alpha· 2025-09-26 14:56
I have a B.Tech degree in Mechanical Engineering from a top school in India. For nearly twenty five years, I have worked in the oil and gas sector, primarily in the Middle East. I work at the intersection of engineering, operations, and project management in an industry that does not forgive mistakes - so I have learned to be efficient, careful, and disciplined. These traits inform my investment strategy. For much of my professional career, I have maintained a serious and sustained interest in the U.S. equi ...
Viridian Therapeutics Announces Completion of Enrollment in both REVEAL Clinical Trials and Positive Portfolio Updates
Businesswire· 2025-09-15 11:01
Core Insights - Viridian Therapeutics, Inc. has completed enrollment in its phase 3 clinical trials REVEAL-1 and REVEAL-2 for VRDN-003, targeting patients with active and chronic Thyroid Eye Disease (TED) respectively [1] Company Overview - Viridian Therapeutics is a biotechnology company focused on discovering, developing, and commercializing potential best-in-class medicines for serious and rare diseases [1] Product Details - VRDN-003 is a subcutaneously delivered, half-life extended monoclonal antibody that targets the insulin-like growth factor [1]
These Analysts Revise Their Forecasts On Viridian Therapeutics Following Q2 Results
Benzinga· 2025-08-07 18:37
Financial Performance - Viridian Therapeutics reported quarterly losses of $(1.00) per share, beating the analyst consensus estimate of $(1.02) per share [1] - The company reported quarterly sales of $75.000 million, exceeding the analyst consensus estimate of $43.643 million [1] Product Development and Market Position - Veligrotug received Breakthrough Therapy Designation, indicating strong momentum as the company approaches its planned Biologics License Application (BLA) filing and expected commercial launch [2] - The company is making significant progress in commercial preparation and aims to be launch-ready on a Priority Review designation timeline [2] - A recent license agreement with Kissei to develop and commercialize veligrotug and VRDN-003 in Japan further validates the value of the company's programs and potential global opportunities [2] Analyst Ratings and Price Targets - Oppenheimer analyst Leland Gershell maintained an Outperform rating and raised the price target from $28 to $32 [8] - Goldman Sachs analyst Richard Law maintained a Buy rating and raised the price target from $27 to $30 [8] - RBC Capital analyst Lisa Walter maintained an Outperform rating but lowered the price target from $45 to $41 [8] - Wells Fargo analyst Derek Archila maintained an Equal-Weight rating and lowered the price target from $27 to $26 [8] Stock Performance - Following the earnings announcement, Viridian Therapeutics shares fell 4.1% to $16.50 [2]
Viridian Therapeutics(VRDN) - 2025 Q2 - Earnings Call Presentation
2025-08-06 20:00
Thyroid Eye Disease (TED) Portfolio - Veligrotug's BLA submission is planned for the second half of 2025, with a potential U S launch in the second half of 2026, and the EU MAA submission is planned for the first half of 2026[13] - Topline data for VRDN-003's REVEAL-1 and REVEAL-2 trials are expected in the first half of 2026, with a BLA submission planned by year-end 2026[13] - In the THRIVE trial for active TED, the proptosis responder rate at week 15 was 70% for patients receiving veligrotug compared to 5% on placebo (p < 0 0001)[56, 58] - In the THRIVE-2 trial for chronic TED, the proptosis responder rate at week 15 was 56% for patients receiving veligrotug compared to 8% on placebo (p < 0 0001)[79] - 70% of proptosis responders in the THRIVE trial maintained their response at Week 52[69] FcRn Inhibitor Portfolio - VRDN-006 proof-of-concept Phase 1 clinical trial healthy volunteer data is expected in Q3 2025[13] - VRDN-008 is on track for IND submission by year-end 2025[13] - A single dose of VRDN-008 demonstrated a longer half-life and a ~20% deeper and more sustained reduction of IgG compared to efgartigimod in NHPs[149] - The market size of MG and CIDP alone are projected to be over $11 2 billion by 2030[133, 134] Corporate/Financial - Viridian had $563 million in cash as of June 30, 2025, providing a runway into the second half of 2027[13]
Viridian Therapeutics, Inc. (VRDN) Reports Q2 Loss, Misses Revenue Estimates
ZACKS· 2025-08-06 12:46
Financial Performance - Viridian Therapeutics reported a quarterly loss of $1 per share, which aligns with the Zacks Consensus Estimate, compared to a loss of $1.02 per share a year ago [1] - The company posted revenues of $0.08 million for the quarter ended June 2025, missing the Zacks Consensus Estimate by 48.63%, and showing a slight increase from $0.07 million year-over-year [2] - Over the last four quarters, the company has surpassed consensus EPS estimates two times and topped consensus revenue estimates just once [2][3] Stock Performance - Viridian Therapeutics shares have declined approximately 9% since the beginning of the year, while the S&P 500 has gained 7.1% [3] - The current status of estimate revisions translates into a Zacks Rank 3 (Hold) for the stock, indicating expected performance in line with the market in the near future [6] Future Outlook - The current consensus EPS estimate for the coming quarter is -$0.96 on revenues of $0.15 million, and for the current fiscal year, it is -$3.96 on revenues of $0.33 million [7] - The outlook for the industry, specifically the Medical - Biomedical and Genetics sector, is currently in the bottom 42% of over 250 Zacks industries, which may impact the stock's performance [8]
Viridian Therapeutics(VRDN) - 2025 Q2 - Quarterly Report
2025-08-06 11:09
[PART I. FINANCIAL INFORMATION](index=6&type=section&id=PART%20I.%20FINANCIAL%20INFORMATION) [Financial Statements](index=6&type=section&id=Item%201.%20Financial%20Statements) This section presents the unaudited condensed consolidated financial statements for the quarter ended June 30, 2025, including balance sheets, statements of operations, stockholders' equity, and cash flows, with a net loss of $187.6 million and an accumulated deficit of $1.18 billion as of June 30, 2025 Condensed Consolidated Balance Sheet Highlights (in thousands) | | June 30, 2025 | December 31, 2024 | | :--- | :--- | :--- | | **Assets** | | | | Cash and cash equivalents | $117,324 | $99,594 | | Short-term investments | $446,032 | $617,990 | | Total assets | $582,324 | $742,403 | | **Liabilities & Equity** | | | | Total liabilities | $67,155 | $70,764 | | Total stockholders' equity | $515,169 | $671,639 | | Accumulated deficit | $(1,183,504) | $(995,857) | Condensed Consolidated Statements of Operations (in thousands, except per share data) | | Three Months Ended June 30, | Six Months Ended June 30, | | :--- | :--- | :--- | | | **2025** | **2024** | **2025** | **2024** | | Collaboration revenue - related party | $75 | $72 | $147 | $144 | | Research and development | $86,626 | $56,193 | $163,461 | $97,136 | | General and administrative | $20,216 | $16,066 | $37,319 | $31,091 | | **Loss from operations** | **$(106,767)** | **$(72,187)** | **$(200,633)** | **$(128,083)** | | **Net loss** | **$(100,735)** | **$(64,993)** | **$(187,647)** | **$(113,535)** | | Net loss per share, basic and diluted | $(1.00) | $(0.77) | $(1.87) | $(1.37) | Condensed Consolidated Statements of Cash Flows Highlights (in thousands) | | Six Months Ended June 30, | | :--- | :--- | | | **2025** | **2024** | | Net cash used in operating activities | $(168,026) | $(91,281) | | Net cash provided by (used in) investing activities | $175,780 | $(81,069) | | Net cash provided by financing activities | $9,976 | $177,190 | | **Net increase in cash and cash equivalents** | **$17,730** | **$4,840** | [Note 1: Description of Business and Liquidity](index=11&type=section&id=1.%20DESCRIPTION%20OF%20BUSINESS) This note details the company's focus on developing medicines for rare diseases, its accumulated deficit of $1.18 billion, and its $563.4 million in cash and investments, sufficient to fund operations for at least the next twelve months - The company's most advanced program is veligrotug, a monoclonal antibody targeting IGF-1R for the treatment of Thyroid Eye Disease (TED), also developing VRDN-003 and a portfolio of FcRn inhibitors (VRDN-006, VRDN-008) for autoimmune diseases[27](index=27&type=chunk)[28](index=28&type=chunk) - As of June 30, 2025, the company had an accumulated deficit of **$1.18 billion** and expects to continue generating operating losses for the foreseeable future[29](index=29&type=chunk) - The company had approximately **$563.4 million** in cash, cash equivalents, and short-term investments as of June 30, 2025, and believes these resources are sufficient to fund operations and capital expenditures for at least the next twelve months[31](index=31&type=chunk) [Note 5: Debt](index=19&type=section&id=5.%20DEBT) This note outlines the company's amended loan agreement with Hercules Capital, providing access to $150.0 million, with $20.0 million drawn and an interest-only period extended to April 2026 - The amended term loan with Hercules Capital provides access to up to **$150.0 million**, with **$20.0 million** drawn as of the report date[85](index=85&type=chunk)[86](index=86&type=chunk) - The interest-only payment period was extended to **April 1, 2026**, due to the achievement of development milestones related to positive topline results from the Phase 3 THRIVE and THRIVE-2 trials[88](index=88&type=chunk) Debt Summary (as of June 30, 2025, in thousands) | Component | Amount | | :--- | :--- | | Gross term loan proceeds | $20,000 | | Accrued end-of-term fee | $788 | | **Total debt** | **$20,788** | | Less: current portion | $(8,435) | | **Long-term debt, net** | **$12,353** | [Note 6: Collaboration Agreements](index=21&type=section&id=6.%20COLLABORATION%20AGREEMENTS) This note details collaboration agreements, including a license with Zenas BioPharma generating minor revenue and related-party agreements with Paragon Therapeutics resulting in $4.5 million in R&D costs in H1 2025 - The license agreement with Zenas BioPharma for IGF-1R antibody products in China was sublicensed to Zai Lab in January 2025, with the company recognizing **$0.1 million** in related collaboration revenue in H1 2025[92](index=92&type=chunk)[95](index=95&type=chunk) - The agreements with Paragon Therapeutics are considered related-party transactions, with the company recording **$4.5 million** in R&D costs in H1 2025, including a **$3.5 million** payment for achieving R&D objectives and a **$1.0 million** clinical milestone payment[103](index=103&type=chunk)[104](index=104&type=chunk)[105](index=105&type=chunk) [Note 7: Commitments and Contingencies](index=23&type=section&id=7.%20COMMITMENTS%20AND%20CONTINGENCIES) This note describes significant financial commitments, including potential milestone payments of up to $48.0 million to ImmunoGen and $45.0 million to Enable Injections, plus $2.7 million in future minimum lease obligations - The company is obligated to make potential future development milestone payments of up to **$48.0 million** to ImmunoGen (acquired by AbbVie) and up to **$45.0 million** to Enable Injections upon achieving specified milestones[107](index=107&type=chunk)[110](index=110&type=chunk) Future Lease Payments (as of June 30, 2025, in thousands) | Period | Amount | | :--- | :--- | | 2025 (remainder) | $367 | | 2026 | $748 | | 2027 | $613 | | 2028 | $627 | | 2029 | $370 | | **Total future minimum lease payments** | **$2,725** | [Note 8: Capital Stock](index=27&type=section&id=8.%20CAPITAL%20STOCK) This note details the company's capital structure, including a new $300.0 million ATM sales agreement established in March 2025 and a $150.0 million public offering completed in January 2024 - In March 2025, the company entered into a new Open Market Sale Agreement (ATM) with Jefferies for up to **$300.0 million** of its common stock, terminating the prior September 2022 ATM agreement, with no shares sold under the new agreement during the quarter[124](index=124&type=chunk) - In January 2024, the company raised approximately **$150.0 million** in gross proceeds from a public offering of 7,142,858 shares of common stock[125](index=125&type=chunk) [Note 10: Share-Based Compensation](index=29&type=section&id=10.%20SHARE-BASED%20COMPENSATION) This note reports $10.8 million in share-based compensation expense for Q2 2025 and $21.1 million for H1 2025, alongside stockholder approval for an 8,000,000 share increase to the 2016 Equity Incentive Plan Share-Based Compensation Expense (in thousands) | | Three Months Ended June 30, 2025 | Six Months Ended June 30, 2025 | | :--- | :--- | :--- | | Research and development | $5,173 | $10,921 | | General and administrative | $5,671 | $10,143 | | **Total** | **$10,844** | **$21,064** | - In June 2025, stockholders approved an **8,000,000 share** increase to the 2016 Equity Incentive Plan[138](index=138&type=chunk) - As of June 30, 2025, there was **$106.3 million** of total unrecognized share-based compensation cost related to stock options and **$14.3 million** related to unvested RSUs[149](index=149&type=chunk) [Note 13: Subsequent Events](index=34&type=section&id=13.%20SUBSEQUENT%20EVENTS) This note discloses a July 2025 collaboration and license agreement with Kissei Pharmaceutical for veligrotug and VRDN-003 in Japan, including a $70.0 million upfront payment and potential milestones - The agreement with Kissei includes a **$70.0 million** upfront payment to Viridian[159](index=159&type=chunk) - Viridian is eligible to receive up to an additional **$315.0 million** in development, regulatory, and sales milestones, plus tiered royalties ranging from the twenties to the mid-thirties on future net sales in Japan[159](index=159&type=chunk) [Management's Discussion and Analysis of Financial Condition and Results of Operations](index=35&type=section&id=Item%202.%20Management%27s%20Discussion%20and%20Analysis%20of%20Financial%20Condition%20and%20Results%20of%20Operations) Management discusses the company's financial condition, clinical program progress for TED and FcRn inhibitors, increased R&D and G&A expenses, and a projected cash runway into the second half of 2027 [Overview and Recent Developments](index=35&type=section&id=Overview%20and%20Recent%20Developments) The company is advancing its pipeline for TED and autoimmune diseases, with veligrotug nearing BLA submission, VRDN-003 in pivotal trials, and FcRn inhibitors progressing towards proof-of-concept data and IND submission - Veligrotug (TED Program): Received FDA Breakthrough Therapy designation in May 2025, with a BLA submission anticipated in H2 2025 and an MAA submission to the EMA in H1 2026[170](index=170&type=chunk) - VRDN-003 (Subcutaneous TED Program): Pivotal Phase 3 trials (REVEAL-1 and REVEAL-2) are ongoing, with topline data expected in H1 2026 and a BLA submission anticipated by the end of 2026[173](index=173&type=chunk) - FcRn Inhibitor Program: Proof-of-concept IgG reduction data for VRDN-006 is expected in Q3 2025, and an IND for the half-life extended VRDN-008 is planned for submission by the end of 2025[175](index=175&type=chunk)[176](index=176&type=chunk) [Results of Operations](index=39&type=section&id=Results%20of%20Operations) This section compares financial results, highlighting significant increases in R&D expenses due to advancing clinical trials and manufacturing, and higher G&A costs driven by personnel and pre-commercialization activities Comparison of Operating Expenses (in thousands) | | Three Months Ended June 30, | Six Months Ended June 30, | | :--- | :--- | :--- | | | **2025** | **2024** | **2025** | **2024** | | Research and development | $86,626 | $56,193 | $163,461 | $97,136 | | General and administrative | $20,216 | $16,066 | $37,319 | $31,091 | - R&D expenses for the six months ended June 30, 2025, increased by **$66.3 million** compared to the same period in 2024, driven by a **$41.2 million** increase in TED portfolio costs and a **$19.7 million** increase in FcRn portfolio costs[199](index=199&type=chunk)[201](index=201&type=chunk)[204](index=204&type=chunk) - G&A expenses for the six months ended June 30, 2025, increased by **$6.2 million** compared to the prior year period, primarily due to a **$4.4 million** increase in personnel costs, a **$3.3 million** increase in market research for veligrotug, and a **$2.5 million** increase in professional fees[205](index=205&type=chunk)[209](index=209&type=chunk) [Liquidity and Capital Resources](index=43&type=section&id=Liquidity%20and%20Capital%20Resources) As of June 30, 2025, the company had $563.4 million in cash and investments, expected to fund operations into H2 2027, with net cash used in operations increasing to $168.0 million in H1 2025 - The company's cash, cash equivalents, and short-term investments totaled **$563.4 million** as of June 30, 2025[206](index=206&type=chunk) - The current cash position is expected to fund planned operations into the **second half of 2027**[206](index=206&type=chunk) Summarized Cash Flows (in thousands) | | Six Months Ended June 30, | | :--- | :--- | | | **2025** | **2024** | | Net cash used in operating activities | $(168,026) | $(91,281) | | Net cash provided by (used in) investing activities | $175,780 | $(81,069) | | Net cash provided by financing activities | $9,976 | $177,190 | [Quantitative and Qualitative Disclosures about Market Risk](index=46&type=section&id=Item%203.%20Quantitative%20and%20Qualitative%20Disclosures%20about%20Market%20Risk) The company reports no material changes to its market risks during the six months ended June 30, 2025, compared to its prior annual report disclosures - No material changes to market risks were reported for the period[227](index=227&type=chunk) [Controls and Procedures](index=46&type=section&id=Item%204.%20Controls%20and%20Procedures) Management concluded that disclosure controls and procedures were effective as of quarter-end, with no material changes to internal control over financial reporting during the period - Based on an evaluation as of the end of the quarter, the principal executive officer and principal financial officer concluded that the company's disclosure controls and procedures were effective[230](index=230&type=chunk) - There have been no changes in internal control over financial reporting during the most recent fiscal quarter that have materially affected, or are reasonably likely to materially affect, internal controls[231](index=231&type=chunk) [PART II. OTHER INFORMATION](index=47&type=section&id=PART%20II.%20OTHER%20INFORMATION) [Legal Proceedings](index=47&type=section&id=Item%201.%20Legal%20Proceedings) The company is not currently a party to any legal proceedings that would have a material adverse effect on its business, financial condition, or results of operations - The company is not currently a party to any material legal proceedings[233](index=233&type=chunk) [Risk Factors](index=47&type=section&id=Item%201A.%20Risk%20Factors) This section outlines key risks including significant financial losses, the high cost and uncertainty of clinical trials, reliance on third-party manufacturers like WuXi Biologics, intense competition, intellectual property challenges, and evolving regulatory landscapes - Financial Risk: The company has a history of significant losses, with a **$1.18 billion** accumulated deficit, and will require substantial additional capital to fund operations beyond its current cash runway, which is projected into the **second half of 2027**[235](index=235&type=chunk)[236](index=236&type=chunk) - Third-Party and Geopolitical Risk: The company relies heavily on third-party manufacturers, including the Chinese CDMO WuXi Biologics, and proposed U.S. legislation like the BIOSECURE Act could disrupt this relationship, potentially forcing a costly and delayed transition to alternative suppliers[335](index=335&type=chunk)[344](index=344&type=chunk) - Clinical and Regulatory Risk: The company's success is dependent on costly and inherently risky clinical trials, and failure to demonstrate safety and efficacy or to obtain regulatory approval would materially harm the business, as the regulatory process is lengthy, unpredictable, and subject to changes in policy[258](index=258&type=chunk)[269](index=269&type=chunk) - Commercialization Risk: The company faces substantial competition from large, well-funded companies like Amgen in the TED market and must build its own commercial capabilities to launch products successfully, if approved[305](index=305&type=chunk)[311](index=311&type=chunk) - Intellectual Property Risk: The business depends on protecting licensed and owned intellectual property, facing risks of infringement claims from third parties and challenges to the validity of its patents, which could be expensive and time-consuming to defend[354](index=354&type=chunk)[373](index=373&type=chunk) [Unregistered Sales of Equity Securities and Use of Proceeds](index=87&type=section&id=Item%202.%20Unregistered%20Sales%20of%20Equity%20Securities%20and%20Use%20of%20Proceeds) The company reported no unregistered sales of equity securities during the period - None[468](index=468&type=chunk) [Other Information](index=88&type=section&id=Item%205.%20Other%20Information) The company states that no directors or officers adopted or terminated any Rule 10b5-1 or non-Rule 10b5-1 trading arrangements during the quarter - No directors or officers adopted or terminated a Rule 10b5-1 trading arrangement during the quarter[471](index=471&type=chunk) [Exhibits](index=88&type=section&id=Item%206.%20Exhibits) This section provides an index of exhibits filed with the quarterly report, including corporate governance documents and officer certifications
Viridian Therapeutics(VRDN) - 2025 Q2 - Quarterly Results
2025-08-06 11:03
[Business Highlights and Pipeline Update](index=1&type=section&id=Business%20Highlights%20and%20Pipeline%20Update) Viridian highlights progress on its lead TED drug candidates, FcRn inhibitor pipeline, and a Japan licensing deal [Veligrotug Program for Thyroid Eye Disease (TED)](index=1&type=section&id=Veligrotug%20Program%20for%20Thyroid%20Eye%20Disease%20%28TED%29) Veligrotug, Viridian's lead candidate for TED, received FDA **Breakthrough Therapy Designation (BTD)** and met all Phase 3 trial endpoints - The FDA granted **Breakthrough Therapy Designation (BTD)** to veligrotug, a status for drug candidates that may offer substantial improvement over existing therapies. This was based on its robust improvement in diplopia and rapid proptosis response[1](index=1&type=chunk)[7](index=7&type=chunk) - Veligrotug successfully met all primary and secondary endpoints in its two pivotal Phase 3 trials, THRIVE (active TED) and THRIVE-2 (chronic TED)[4](index=4&type=chunk) - Long-term data from the THRIVE trial showed strong durability, with **70% of patients** who responded to proptosis treatment at 15 weeks maintaining that response at 52 weeks, 40 weeks after the last dose[7](index=7&type=chunk) - A Biologics License Application (BLA) submission to the U.S. FDA is on track for the second half of 2025, with a potential U.S. commercial launch in 2026[1](index=1&type=chunk)[7](index=7&type=chunk) [VRDN-003 Program for Thyroid Eye Disease (TED)](index=2&type=section&id=VRDN-003%20Program%20for%20Thyroid%20Eye%20Disease%20%28TED%29) VRDN-003, a subcutaneously delivered TED antibody, aims for infrequent self-administration with pivotal data expected 1H 2026 - Topline data from the pivotal clinical trials, REVEAL-1 and REVEAL-2, are expected in the first half of 2026[7](index=7&type=chunk) - The company plans to submit a BLA for VRDN-003 by the end of 2026[7](index=7&type=chunk) - VRDN-003 is designed for infrequent self-administration at home using a low-volume autoinjector[7](index=7&type=chunk) - VRDN-003 has a half-life of **40-50 days**, which is **4-5 times longer** than veligrotug, potentially allowing for dosing every 4 or 8 weeks (Q4W/Q8W)[14](index=14&type=chunk) [Japan Licensing Agreement with Kissei Pharmaceutical](index=1&type=section&id=Japan%20Licensing%20Agreement%20with%20Kissei%20Pharmaceutical) Viridian entered an exclusive licensing agreement with Kissei Pharmaceutical for veligrotug and VRDN-003 in Japan Kissei Pharmaceutical Licensing Deal Terms | Term | Value | | :--- | :--- | | Upfront Cash Payment | $70 million | | Potential Future Milestones | Up to $315 million | | Royalties on Net Sales | Tiered, ranging from 20s to mid-30s | - Kissei will be responsible for all development, regulatory, and commercialization activities and costs in Japan[7](index=7&type=chunk) [FcRn Inhibitor Portfolio](index=2&type=section&id=FcRn%20Inhibitor%20Portfolio) Viridian advances its FcRn inhibitor portfolio, with key data and IND submissions anticipated in 2025 - VRDN-006: Data from the Phase 1 clinical trial in healthy volunteers, including proof-of-concept IgG reduction, is expected in **Q3 2025**[7](index=7&type=chunk)[11](index=11&type=chunk) - VRDN-008: An Investigational New Drug (IND) submission is on track for **year-end 2025**[7](index=7&type=chunk)[11](index=11&type=chunk) - In non-human primate studies, VRDN-008 demonstrated a **longer half-life** and **more sustained IgG reduction** compared to efgartigimod[7](index=7&type=chunk)[16](index=16&type=chunk) [Expected Upcoming Milestones](index=2&type=section&id=Expected%20Upcoming%20Milestones) Viridian outlines key upcoming milestones for its portfolio, including BLA submissions and clinical data readouts - **Veligrotug:** - BLA submission in **2H 2025** - U.S. commercial launch in **2026** (if approved) - MAA submission in **1H 2026**[7](index=7&type=chunk) - **VRDN-003:** - Topline data in **1H 2026**[7](index=7&type=chunk) - **VRDN-006:** - Healthy volunteer clinical data in **Q3 2025**[11](index=11&type=chunk) - **VRDN-008:** - IND submission by **year-end 2025**[11](index=11&type=chunk) [Second Quarter 2025 Financial Results](index=1&type=section&id=Second%20Quarter%202025%20Financial%20Results) Viridian reports Q2 2025 financial results, detailing cash position, operating expenses, and balance sheet [Financial Summary](index=1&type=section&id=Financial%20Summary) Viridian ended Q2 2025 with **$563.4 million** cash, extending its runway into **2H 2027** Key Financial & Operational Metrics (Q2 2025) | Metric | Value | | :--- | :--- | | Cash, Cash Equivalents & Short-Term Investments | **$563.4 million** (as of June 30, 2025) | | Cash Runway | Into **2H 2027** | | Q2 2025 R&D Expenses | **$86.6 million** | | Q2 2025 G&A Expenses | **$20.2 million** | | Common Stock Outstanding | **100,320,386 shares** (as-converted basis) | - The increase in R&D expenses was driven by costs for multiple ongoing Phase 3 trials (veligrotug, VRDN-003) and a Phase 1 trial (VRDN-006)[11](index=11&type=chunk) - The increase in G&A expenses was primarily due to preparatory commercial activities for veligrotug and increased professional service and personnel costs[11](index=11&type=chunk) [Condensed Consolidated Statements of Operations](index=6&type=section&id=Condensed%20Consolidated%20Statements%20of%20Operations) Viridian reported a Q2 2025 net loss of **$100.7 million**, reflecting increased operating expenses year-over-year Statement of Operations Highlights (Three Months Ended June 30) | Metric (in thousands USD) | 2025 | 2024 | | :--- | :--- | :--- | | Total revenue | $75 | $72 | | Research and development | $86,626 | $56,193 | | General and administrative | $20,216 | $16,066 | | **Loss from operations** | **($106,767)** | **($72,187)** | | **Net loss** | **($100,735)** | **($64,993)** | | Net loss per share, common | ($1.00) | ($0.77) | [Condensed Consolidated Balance Sheets](index=7&type=section&id=Condensed%20Consolidated%20Balance%20Sheets) As of June 30, 2025, Viridian's total assets decreased to **$582.3 million**, primarily due to cash utilization Balance Sheet Highlights (in thousands USD) | Metric | June 30, 2025 | December 31, 2024 | | :--- | :--- | :--- | | Cash, cash equivalents and short-term investments | $563,356 | $717,584 | | **Total assets** | **$582,324** | **$742,403** | | Total liabilities | $67,155 | $70,764 | | **Total stockholders' equity** | **$515,169** | **$671,639** |
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]