Group 1 - The Growth Stock Forum focuses on identifying attractive growth stocks, particularly in the biotech sector, emphasizing risk/reward situations [1][2] - The forum features a model portfolio of 15-20 stocks, a top picks list of up to 10 stocks expected to perform well, and trading ideas for short-term and medium-term strategies [2] - Community engagement is encouraged through dialogue and Q&A sessions, enhancing the collaborative investment approach [2] Group 2 - The author has disclosed a beneficial long position in specific stocks, indicating a personal investment interest in VRDN, ARGX, and IMVT [3] - The article reflects the author's personal opinions and does not constitute a buy or sell recommendation [4] - Seeking Alpha emphasizes that past performance does not guarantee future results and that views expressed may not represent the platform as a whole [5]

Core Insights - Viridian Therapeutics is included in the model portfolio of the Biotech Forum, which is currently offering a one-month trial at half the regular price [1] - The company had key catalysts that were anticipated, with one being disclosed recently, resulting in a stock price increase of just over a certain percentage [2] Company Overview - Viridian Therapeutics, Inc. (NASDAQ: VRDN) is a biopharmaceutical company that is actively monitored by investment analysts [2] - The Biotech Forum, led by Bret, provides a model portfolio featuring 12-20 high upside biotech stocks, along with live discussions and weekly updates [2] Investment Position - The analyst has a beneficial long position in the shares of VRDN, indicating confidence in the company's future performance [3]

Core Insights - Viridian Therapeutics, Inc. (VRDN) reported a quarterly loss of $1.15 per share, which was worse than the Zacks Consensus Estimate of a loss of $1.11, marking an earnings surprise of -3.60% [1] - The company generated revenues of $0.09 million for the quarter ended September 2024, exceeding the Zacks Consensus Estimate by 4.88% and showing a year-over-year increase from $0.07 million [2] - The stock has underperformed the market, gaining about 18% year-to-date compared to the S&P 500's gain of 25.8% [3] Financial Performance - Over the last four quarters, Viridian Therapeutics has surpassed consensus EPS estimates only once [2] - The current consensus EPS estimate for the upcoming quarter is -$1.03 on revenues of $0.09 million, and for the current fiscal year, it is -$3.94 on revenues of $0.21 million [7] Industry Context - The Medical - Biomedical and Genetics industry, to which Viridian Therapeutics belongs, is currently ranked in the top 29% of over 250 Zacks industries, indicating a favorable outlook compared to lower-ranked industries [8] - Empirical research suggests a strong correlation between near-term stock movements and trends in earnings estimate revisions, which can be tracked using tools like the Zacks Rank [5][6]

Product Development - The company is developing two product candidates for TED: veligrotug (IV) and VRDN-003 (subcutaneous), with veligrotug showing a 71% proptosis response rate in active TED patients [190]. - The THRIVE study for veligrotug enrolled 113 patients, achieving all primary and secondary endpoints with a statistical significance of p < 0.0001 [191]. - VRDN-003 has a prolonged half-life of 40 to 50 days, which is four to five times that of veligrotug, and is designed for low-volume, self-administration [194]. - The company is prioritizing the development of engineered anti-FcRn inhibitors, including VRDN-006 and VRDN-008, targeting a significant commercial market opportunity [195]. - VRDN-006 demonstrated comparable potency to the current standard of care in FcRn inhibition, with plans to file an IND by the end of 2024 [196]. - The company anticipates filing a Biologics License Application (BLA) for veligrotug in the second half of 2025 and for VRDN-003 by the end of 2026 [191][194]. Financial Performance - Collaboration revenue for the three months ended September 30, 2024, was $86,000, compared to $72,000 in 2023, reflecting a $14,000 increase [210]. - Research and development expenses increased to $69.2 million for the three months ended September 30, 2024, from $30.4 million in 2023, a rise of $38.8 million [212]. - General and administrative expenses decreased to $14.4 million for the three months ended September 30, 2024, down from $20.9 million in 2023, a decrease of $6.5 million [215]. - Other income, net was $6.8 million for the three months ended September 30, 2024, compared to $3.6 million in 2023, an increase of $3.2 million [216]. - For the nine months ended September 30, 2024, research and development expenses totaled $166.3 million, up from $121.2 million in 2023, an increase of $45.1 million [218]. - General and administrative expenses for the nine months ended September 30, 2024, were $45.5 million, down from $62.0 million in 2023, a decrease of $16.5 million [223]. - Other income, net for the nine months ended September 30, 2024, was $21.3 million, compared to $12.1 million in 2023, an increase of $9.2 million [225]. - The company’s net loss for the nine months ended September 30, 2024, was $190.2 million, compared to a net loss of $170.9 million for the same period in 2023 [248][249]. Cash Flow and Capital Resources - As of September 30, 2024, the company had $753.2 million in cash, cash equivalents, and short-term investments, expected to fund operations into the second half of 2027 [228]. - The company has generated an accumulated deficit of $916.1 million since inception, primarily due to research and development expenses [229]. - The company anticipates requiring substantial additional capital to continue the development of product candidates and fund ongoing operations [230]. - The company entered into a loan and security agreement with Hercules Capital, providing access to a term loan of up to $150 million, with an initial tranche of $50 million drawn at closing [239]. - The company recognized a loss on debt extinguishment of $0.2 million in August 2023 related to the Hercules Amendment [238]. - Net cash used in operating activities was $159.0 million for the nine months ended September 30, 2024, compared to $146.2 million for the same period in 2023, reflecting an increase of $12.8 million [248][249]. - Net cash used in investing activities was $165.7 million for the nine months ended September 30, 2024, compared to net cash provided of $75.5 million in the same period in 2023, indicating a decrease of $241.2 million [250][251]. - Net cash provided by financing activities was $422.2 million during the nine months ended September 30, 2024, a significant increase from $26.7 million in the same period in 2023 [253][254]. - The company completed a public offering in January 2024, raising approximately $150 million from the sale of 7,142,858 shares at $21.00 per share [243]. - In September 2024, the company raised approximately $258.8 million from the sale of 12,466,600 shares at $18.75 per share, including additional shares from underwriters' options [244]. - The company sold 1,561,570 shares under the September 2022 ATM Agreement at a weighted average price of $23.22 per share, generating approximately $35.2 million in net proceeds during the nine months ended September 30, 2024 [246]. Market and Economic Conditions - The company expects revenue fluctuations based on the timing of achieving development and commercial milestones [201]. - The global macroeconomic environment presents uncertainties that could negatively affect future operations, including trade disputes and geopolitical tensions [197]. - The company’s Amended Term Loan has a maturity date of October 1, 2026, with an interest rate capped at 8.95% [240][242].

Clinical Trials and Drug Development - Reported positive topline phase 3 data for veligrotug in patients with active thyroid eye disease (TED), achieving all primary and secondary endpoints with high statistical significance (p < 0.0001) after five infusions[4] - THRIVE-2 trial completed enrollment with 188 patients, exceeding the target of 159, and topline data expected in December 2024[4] - VRDN-003, a next-generation subcutaneous IGF-1R inhibitor, has two global phase 3 trials (REVEAL-1 and REVEAL-2) initiated in August 2024, with topline data expected in the first half of 2026[6] - VRDN-006 is on track for IND submission by year-end 2024, with proof-of-concept IgG reduction data anticipated in the second half of 2025[7] - VRDN-008 demonstrated a threefold longer half-life compared to efgartigimod in non-human primate studies, with deeper IgG reductions[8] - Biologics License Application (BLA) for veligrotug is anticipated in the second half of 2025, pending data[5] Financial Performance - Net loss for Q3 2024 was $76.7 million, compared to $47.7 million for the same period last year[10] - Total revenue for the three months ended September 30, 2024, was $86,000, compared to $72,000 for the same period in 2023, representing a 19.4% increase[15] - Total operating expenses for the three months ended September 30, 2024, were $83,566,000, up from $51,296,000 in the prior year, reflecting a 62.8% increase[15] - The net loss for the three months ended September 30, 2024, was $76,689,000, compared to a net loss of $47,660,000 for the same period in 2023, indicating a 60.9% increase in losses[15] - The company reported a comprehensive loss of $75,214,000 for the three months ended September 30, 2024, compared to a comprehensive loss of $47,551,000 for the same period in 2023, reflecting a 58.4% increase[15] - The net loss per share, basic and diluted, was $(1.15) for the three months ended September 30, 2024, compared to $(1.09) for the same period in 2023[15] Expenses and Investments - Research and development expenses increased to $69.2 million for Q3 2024, compared to $30.4 million for Q3 2023, driven by higher clinical trial costs[10] - General and administrative expenses decreased to $14.4 million for Q3 2024, down from $20.9 million for Q3 2023, due to reduced personnel-related costs[10] - Research and development expenses for the three months ended September 30, 2024, were $69,158,000, significantly higher than $30,385,000 in the prior year, indicating a 128.3% increase[15] Cash and Assets - Cash, cash equivalents, and short-term investments totaled $753.2 million as of September 30, 2024, up from $571.4 million as of June 30, 2024, following a public offering that generated net proceeds of $243.2 million[10] - Cash, cash equivalents, and short-term investments increased to $753,240,000 as of September 30, 2024, from $477,370,000 at the end of 2023, showing a 57.6% growth[16] - Total assets rose to $771,900,000 as of September 30, 2024, compared to $490,424,000 at the end of 2023, marking a 57.4% increase[16] - Total stockholders' equity increased to $707,496,000 as of September 30, 2024, up from $442,022,000 at the end of 2023, representing a 60.1% rise[16] Shareholder Information - The weighted-average shares used to compute basic and diluted loss per share increased to 66,420,063 for the three months ended September 30, 2024, from 43,654,577 in the same period of 2023[15]

Core Viewpoint - Viridian Therapeutics, Inc. announced positive results from the phase III THRIVE study for its lead drug veligrotug, leading to a 32.1% surge in share price on September 10 [1]. Study Results - The THRIVE study met all primary and secondary endpoints, showing statistically significant improvements in thyroid eye disease (TED) symptoms after 15 weeks of treatment with veligrotug [2]. - Patients receiving veligrotug had a 70% proptosis responder rate compared to 5% for the placebo group, with a mean reduction in proptosis of 2.9 mm versus 0.5 mm [3]. - Complete resolution of diplopia was observed in 54% of patients treated with veligrotug, compared to 12% in the placebo group [4]. - An overall response rate of 67% was achieved in the veligrotug group versus 5% in the placebo group, indicating the treatment was generally safe and well tolerated [5]. Future Plans - Viridian plans to file a biologics license application (BLA) for veligrotug in the second half of 2025 and is also evaluating another candidate, VRDN-003, in late-stage studies for TED [6][7]. - Top-line data from the phase III studies for VRDN-003 is expected in the first half of 2026, with a BLA filing anticipated by the end of 2026 [8]. Competitive Landscape - If approved, veligrotug and VRDN-003 will face competition from Amgen's Tepezza, the first approved drug for TED, which is administered intravenously [9]. - Amgen is also developing a subcutaneous formulation of Tepezza, which may offer a more convenient administration method compared to intravenous drugs [9][10].

Core Insights - Viridian Therapeutics has released positive data from its phase 3 THRIVE study for veligrotug, which treats active thyroid eye disease (TED), achieving a 70% proptosis responder rate compared to 5% for placebo [2][3] - The company plans to file a Biologics License Application (BLA) for veligrotug for both active and chronic TED by the second half of 2025, with additional data from the THRIVE-2 study expected by the end of 2024 [1][8] - Viridian is also developing other candidates, including VRDN-006 for autoimmune disorders and VRDN-008 with extended half-life technology, which may provide competitive advantages in a crowded market [4][8] Company Developments - The THRIVE study involved 154 patients, randomized to receive either 10 mg/kg of veligrotug or placebo over 15 weeks, with a primary endpoint of proptosis responder rate [3] - The primary endpoint was met with statistical significance (p<0.0001), showing a mean reduction in proptosis of 2.9 mm for the drug group versus 0.5 mm for placebo [3] - Viridian's cash position as of June 30, 2024, was $571.4 million, providing a cash runway into the second half of 2026, allowing the company to fund upcoming milestones [5] Market Opportunity - The market for thyroid eye disease is projected to reach $4.13 billion by 2034, indicating significant potential for new treatments [3] - Competition exists with Amgen's Tepezza, which has been on the market since 2020, making it challenging for new entrants like veligrotug to capture market share [3][8] - The anti-FcRn market is becoming crowded, with several players developing similar treatments, necessitating differentiation strategies for Viridian's products [4] Future Catalysts - Results from the THRIVE-2 study are anticipated by the end of 2024, which will be crucial for the company's regulatory strategy [1][8] - Two phase 3 studies for VRDN-003, an anti-IGF-1R monoclonal antibody, were initiated in August 2024, with topline data expected in the first half of 2026 [3][4] - The company aims to initiate a phase 1 study for VRDN-006 by the end of 2024, targeting autoimmune disorders [4]

Group 1 - Viridian Therapeutics Inc (NASDAQ:VRDN) stock increased by 11.1% to $15.75, reaching a high of $16.35 after a late-stage study for its eye disorder treatment met its main goal [1] - Despite the recent increase, VRDN shares are still down 28% year to date, and momentum has not reached the 200-day moving average [2] - A short squeeze may support the stock's upward movement, as short interest decreased by 7.3% in the last two reporting periods, with 8 million shares sold short, representing 12.9% of the total float [2] Group 2 - There has been significant put trading activity for Viridian, with 6,000 puts bought to open in the last 10 days compared to only 460 calls [3]

Investment Rating - The investment rating for Viridian Therapeutics Inc. (VRDN) is "Buy" with a 12-month price target of $25.00, indicating an upside potential of 70.1% from the current price of $14.70 [9]. Core Insights - Viridian Therapeutics Inc. (VRDN) is well-positioned with its VRDN-003 product, which is expected to have best-in-class potential in the subcutaneous (SC) treatment of thyroid eye disease (TED) due to its dosing regimens and autoinjector properties [5][8]. - SLRN has refocused its pipeline strategy to prioritize lonigutamab for TED, moving directly to Phase 3 development by Q1 2025, which increases competitive pressure on VRDN-003 [2][3]. - VRDN plans to initiate Phase 3 trials for VRDN-003 in August 2024, with topline data expected in the first half of 2026, ahead of SLRN's timelines [3][5]. Summary by Sections Pipeline Strategy - SLRN has discontinued investments in HS/PsA and reduced its workforce by 33% to extend its cash runway to mid-2027, focusing solely on lonigutamab for TED [2]. - Early Phase 1/2 data for lonigutamab showed promising results, but VRDN-003's half-life extension and autoinjector features are seen as significant commercial advantages [2][5]. Clinical Development - VRDN-003's Phase 3 REVEAL-1/REVEAL-2 trials are set to begin in August 2024, with topline data expected in 1H26 and a BLA filing by the end of 2026 [3][5]. - SLRN's decision to skip Phase 2b/3 studies and move directly to Phase 3 could intensify competition, but VRDN-003 is anticipated to deliver data from its primary endpoints before SLRN [3][5]. Safety and Efficacy - Updates on tinnitus effects from SLRN's trials indicate that hearing adverse events are mostly transient and manageable, aligning with VRDN's observations [4][5]. - The Phase 3 studies for both VRDN and SLRN may reveal different occurrences of hearing adverse events due to their varying study durations [4].

Viridian Therapeutics, Inc. (VRDN) came out with a quarterly loss of $1.02 per share versus the Zacks Consensus Estimate of a loss of $0.87. This compares to loss of $1.27 per share a year ago. These figures are adjusted for non-recurring items. This quarterly report represents an earnings surprise of -17.24%. A quarter ago, it was expected that this company would post a loss of $1.07 per share when it actually produced a loss of $0.79, delivering a surprise of 26.17%. Over the last four quarters, the compa ...