Summary of Viridian Therapeutics FY Conference Call Company Overview - **Company**: Viridian Therapeutics (NasdaqCM: VRDN) - **Focus**: Development of treatments for thyroid eye disease and other conditions Key Points Industry and Market Context - The company operates in a market valued at **$2 billion** in the U.S. for thyroid eye disease treatments [4] - The company is preparing for significant growth in **2026** with new product launches and regulatory filings [1] Product Development and Regulatory Progress - The company has submitted a **Breakthrough Therapy designation** for its treatment program, highlighting rapid treatment effects observed after just **three weeks** and one infusion [2] - The treatment regimen involves **five infusions** over three months, using **70% less drug** compared to currently approved products [2] - Upcoming **top-line data** for active and chronic populations using a subcutaneous program is expected in **Q1 and Q2** of the following year [3] Clinical Trials and Efficacy - The **REVEAL-1** study targets active patients, while **REVEAL-2** focuses on chronic patients, both designed similarly to previous successful trials [9] - The company aims for a **50%-70%** placebo-adjusted proptosis response, matching the efficacy levels of existing treatments like Tepezza [13] - The design of the studies aims to minimize placebo drift, with consistent operational teams across trials [15] Safety and Patient Impact - The safety profile of the treatment is well understood, with expectations of mild and transient side effects [21] - The urgency for treatment is emphasized, particularly for the predominantly female patient population in their **forties and fifties** suffering from debilitating symptoms [22] Commercial Strategy and Expansion - The company is looking to expand geographically, with plans to file for **Marketing Authorization Application (MAA)** in Europe in **Q1** of the coming year [4] - A partnership in Japan has been established, leveraging existing pricing strategies from approved products [5] Financial Position and Future Outlook - The company recently completed a **royalty deal** and an **equity raise**, positioning itself to reach profitability and break-even [26] - Current cash reserves are reported to be just shy of **$900 million**, providing a strong foundation for executing its portfolio [26] Conclusion - Viridian Therapeutics is poised for significant advancements in the treatment of thyroid eye disease, with a robust pipeline, strategic partnerships, and a solid financial position to support its growth initiatives [27]

Not for distribution to U.S. news wire services or for dissemination in the United States VANCOUVER, British Columbia, Dec. 02, 2025 (GLOBE NEWSWIRE) -- Viridian Metals Inc. (CSE: VRDN) (“Viridian” or the “Company”) is pleased to announce that further to its press release dated November 7, 2025 that it has closed a first tranche (the “First Tranche”) of its non-brokered private placement (the "Offering") consisting of the issuance of a combination of: (i) flow-through shares (“Flow-Through Shares”) of the C ...

Summary of Viridian Therapeutics Conference Call Company Overview - **Company**: Viridian Therapeutics (NasdaqCM: VRDN) - **Industry**: Biotechnology, specifically focusing on treatments for thyroid eye disease and FCRN-related conditions Key Points and Arguments Thyroid Eye Disease (TED) Portfolio - Viridian is targeting the thyroid eye disease market, which is currently valued at **$2 billion annually in the U.S.** with only one approved product available [6][14] - The company has two programs in this portfolio: an intravenous (IV) program (Veligrotug) and a subcutaneous (subQ) program [6][7] - Veligrotug has completed Phase III trials and received breakthrough therapy designation, with a **BLA submitted at the end of October 2025**, aiming for a potential commercial launch in **mid-2026** [7][20] - The subQ program is designed for self-administration via an autoinjector, which could significantly expand the market by allowing patients to manage their treatment at home [8][9] - The TED portfolio has shown robust clinical enrollment, with over **500 patients enrolled in trials this year**, indicating strong commercial demand [9][10] Market Dynamics - The TED market is characterized as a "new start market," meaning Viridian does not need to switch patients from existing therapies, allowing them to capture new patients [13] - There are approximately **20,000 new cases annually in the U.S.**, with a total of **500,000 individuals affected by thyroid eye disease**, of which **200,000 have moderate to severe cases** [14] - The current approved product has low penetration in the market, providing an opportunity for Viridian to capture market share [14][23] FCRN Portfolio - Viridian has two programs in the FCRN space: VRDN-006 (a fragment approach) and VRDN-008 (half-life extended) [10][32] - The company is optimistic about the efficacy and safety profile of VRDN-006, which is expected to show IgG suppression without adverse LDL spikes [11][32] - The FCRN portfolio is positioned to address multiple indications, including Myasthenia Gravis and CIDP, with potential for further expansion into additional indications [32][33] Regulatory and Launch Preparations - The FDA interactions have been positive, with consistent communication over the years, which bodes well for the BLA review process [18][20] - The company is preparing for a commercial launch, leveraging lessons learned from the successful launch of Tepezza, which had a strong market entry despite the pandemic [21][22] - Pricing and insurance coverage have improved, with **85% of commercial plans in the U.S. now covering the current approved product**, which will benefit Viridian as they enter the market [23] Upcoming Milestones - Key upcoming milestones include: - Priority review status for the BLA expected by the end of 2025 - Top-line readouts for the subQ program in **Q1 and Q2 of 2026** - Continued development and data generation for the FCRN programs [35] Additional Important Information - The company is well-capitalized, having completed a royalty deal and equity raise in October, positioning them for profitability [12] - The autoinjector for the subQ program is commercially validated, and a bridging study is underway to support its approval [31][32] This summary encapsulates the critical insights from the conference call, highlighting Viridian Therapeutics' strategic positioning, market opportunities, and upcoming developments in their product pipeline.

Core Insights - Viridian Therapeutics, Inc. (NASDAQ:VRDN) is recognized as a promising small-cap biotech stock with significant upside potential according to analysts [1] Financial Performance - RBC Capital raised its price target for Viridian Therapeutics from $41 to $45 while maintaining an "Outperform" rating, driven by a strong cash position of $888 million resulting from various financing deals [2] - The company reported a cash balance of $490.9 million at the end of Q3 2025, with an increase in R&D expenses from $69.2 million in the same quarter last year to $86.3 million [4] Clinical Developments - Viridian has completed key patient enrollments in late-stage clinical studies, with readouts for active and chronic Thyroid Eye Disease (TED) expected in Q1 and Q2 2026, respectively [3]

Core Viewpoint - Small-cap biotech stocks are experiencing a resurgence, driven by market rotation and improving technical indicators, with healthcare emerging as a constructive sector [2][4] Industry Overview - The Health Care Select Sector SPDR Fund (XLV) has increased by 11.09% in 2025, while the iShares Biotechnology ETF has gained approximately 25% year-to-date [2][3] - Analysts suggest that capital is flowing out of high-flying AI stocks into more attractive healthcare and biotech opportunities [3][4] M&A Activity - Increased mergers and acquisitions (M&A) activity in the biotech sector has been noted, with significant deals including Pfizer's $10 billion acquisition of Metsera and Roche's $3.5 billion acquisition of 89bio [4][5] - This M&A activity is expected to bolster potential upside for both large-cap and small-to-mid-cap biotech companies [4] Methodology for Stock Selection - The list of the best small-cap biotech stocks was curated based on companies with market capitalizations between $300 million and $2 billion, focusing on those with the highest upside potential as of November 10, 2025 [8] Company Highlights - **Viridian Therapeutics, Inc. (NASDAQ:VRDN)**: - Upside potential of 36.71% with a cash position of $888 million and key patient enrollments in late-stage clinical studies [10][11][12] - **UroGen Pharma Ltd. (NASDAQ:URGN)**: - Upside potential of 49.17%, reporting a significant increase in demand revenue and a cash position of $127.4 million [14][15][16] - **Liquidia Corporation (NASDAQ:LQDA)**: - Upside potential of 55.49%, with YUTREPIA achieving profitability earlier than expected and a cash position of $157.5 million [19][20][22]

Summary of Viridian Therapeutics Conference Call Company Overview - **Company**: Viridian Therapeutics - **Industry**: Biopharmaceuticals focusing on autoimmune diseases - **Key Participants**: Steve Mahoney (CEO), Tony Castianos (Chief Commercial Officer), Shan Wu (Chief Business Officer) [1][2] Core Points and Arguments Autoimmune Portfolio - Viridian is advancing an autoimmune portfolio with a focus on thyroid eye disease (TED), a market valued at approximately $2 billion in the U.S. [2] - The company has submitted a Biologics License Application (BLA) for its lead product, which has received breakthrough therapy designation from the FDA [4][2]. Market Dynamics - There is currently one competitor in the TED market, Tepezza, marketed by Amgen, which has shown a return to growth with sales of $560 million in the last quarter [10][11]. - The TED market consists of about 500,000 patients in the U.S., with 200,000 having moderate to severe forms of the disease [10][7]. Product Differentiation - Viridian's product, veligrotug, is expected to have a more favorable dosing regimen compared to Tepezza, requiring five infusions over three months versus eight infusions over five months for Tepezza [15][14]. - The onset of action for veligrotug is anticipated to be quicker, with significant proptosis response observed after just one infusion [15][16]. Clinical Data and Expectations - Phase three data from the THRIVE program indicates strong efficacy, with a proptosis response rate expected to meet or exceed the efficacy bar set by Tepezza [30][29]. - The company plans to launch with both active and chronic data in its label, which is a strategic advantage over Tepezza [17][16]. FCRN Portfolio - Viridian is also developing programs in the FCRN space, with two lead programs (006 and 008) targeting large markets projected to exceed $10 billion by 2030 [31][32]. - The company is focused on low-cost optionality in its FCRN portfolio, with ongoing studies to validate the efficacy and safety of its candidates [33][35]. Financial Position - Viridian recently announced a royalty deal with DRI, which is seen as a validation of its business model and does not encumber its lead products [37][38]. - The company expects to reach break-even and profitability, regardless of the FDA's review outcome [38][39]. Additional Insights - The TED market is characterized as a new start market, allowing for rapid adoption of new therapies without the need to switch patients from existing treatments [11][12]. - The concentration of prescribers in the TED market (approximately 2,000 core prescribers) allows for targeted commercial strategies [12][10]. - The company has engaged with over 500 key opinion leaders (KOLs) in October alone, indicating proactive market preparation [20][19]. This summary encapsulates the key points discussed during the conference call, highlighting the strategic positioning of Viridian Therapeutics within the biopharmaceutical industry, particularly in the treatment of autoimmune diseases.

Core Insights - Viridian Therapeutics, Inc. (NASDAQ:VRDN) is a biotechnology company focused on developing treatments for rare diseases, with RBC Capital setting a price target of $45, indicating a potential increase of about 63.64% from its current price of $27.50, reflecting strong confidence in the company's future performance [1][5] Financial Position - Viridian is positioned for profitability in 2026 due to successful financing transactions that have eliminated the need for further share dilution, which is a positive sign for investors [2][5] - The current stock price of VRDN is $27.50, showing a 12.61% increase or $3.08, with a market capitalization of approximately $2.23 billion and a trading volume of 4.86 million shares today [4] Competitive Landscape - The competitive landscape is shifting as Roche's Enspryng (satralizumab) has shown disappointing phase 3 results in treating thyroid eye disease, which reduces competitive pressure on Viridian's veligrotug and VRDN-003, potentially enhancing its market position and increasing market share in this therapeutic area [3][5]

Core Insights - Viridian Therapeutics, Inc. (NASDAQ:VRDN) has been upgraded to "Outperform" by RBC Capital, with a price target increase from $41 to $45, while the stock is currently priced at $27.45 [1][6] - The company is expected to have a promising year in 2026, having successfully completed financing transactions that will allow it to reach profitability without further share dilution [2][6] - Disappointing phase 3 results of Roche's Enspryng in treating thyroid eye disease have reduced competitive pressure on Viridian's treatments, veligrotug and VRDN-003, enhancing its market position [3][6] Financial Performance - VRDN's stock has seen a 12.41% increase, with a change of $3.03, and has fluctuated between $24.93 and $28.60 on the day of reporting [4] - The company's market capitalization is approximately $2.23 billion, with a trading volume of 3,957,014 shares, indicating strong investor interest [5]

Core Insights - Viridian Therapeutics, Inc. (VRDN) shares have increased by 29% since the last update in December 2024, but are still down 35% from the first published article on Seeking Alpha [2]. Company Performance - The stock has shown significant volatility, with a notable increase recently but a substantial decline since the initial coverage [2]. Investment Strategy - The focus is on identifying growth and biotech stocks with high growth potential, emphasizing risk-adjusted returns [2]. - The investment group, Growth Stock Forum, maintains a model portfolio of 15-20 stocks and a top picks list of up to 10 stocks expected to perform well in the current calendar year [2].

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 veligrotug showing a 71% proptosis response rate in active TED patients [184]. - Veligrotug's phase 3 clinical trials, THRIVE and THRIVE-2, achieved all primary and secondary endpoints with statistical significance (p < 0.0001) and demonstrated a 70% durability of response at 52 weeks [185]. - 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 for TED [187]. - The company completed enrollment in the STRIVE clinical trial with 231 patients, exceeding the target of 212 due to high demand, to meet safety database requirements for veligrotug [185]. - The REVEAL-1 and REVEAL-2 trials for VRDN-003 enrolled 132 and 204 patients, respectively, surpassing their target enrollments due to demand [188]. - VRDN-006, an engineered FcRn inhibitor, demonstrated comparable potency to the current standard of care, efgartigimod, while sparing albumin and LDL levels [190]. - VRDN-008, another FcRn inhibitor, showed three times the half-life of efgartigimod and deeper IgG reductions, with a potential IND submission anticipated by the end of 2025 [191]. - The company anticipates submitting a Biologics License Application (BLA) for VRDN-003 by the end of 2026 [188]. Financial Performance - Revenue primarily consists of up-front payments for licenses, milestone payments, and research and development services under collaboration agreements [193]. - License revenue for the three months ended September 30, 2025 was $70.0 million, attributed to the collaboration and license agreement with Kissei [205]. - Research and development expenses for the three months ended September 30, 2025 increased by $17.1 million to $86.3 million compared to $69.2 million in 2024 [205]. - General and administrative expenses for the three months ended September 30, 2025 were $24.3 million, an increase of $9.9 million from $14.4 million in 2024 [210]. - For the nine months ended September 30, 2025, total research and development expenses were $249.7 million, up $83.4 million from $166.3 million in 2024 [211]. - Direct costs related to the TED portfolio increased by $60.4 million during the nine months ended September 30, 2025, primarily due to a $52.2 million increase in clinical trial costs [214]. - The collaboration revenue for the three months ended September 30, 2025 was $570,000, compared to $86,000 in 2024, reflecting an increase of $484,000 [205]. - The company received a $1.0 million milestone payment from Zenas BioPharma under the license agreement [194]. - The company is eligible to receive up to $315.0 million in non-refundable milestone payments from Kissei upon achieving specific milestones [195]. - Increase in chemistry, manufacturing, and controls costs by $8.4 million to support IND-enabling activities for the FcRn inhibitor portfolio [216]. - General and administrative expenses rose to $61.6 million for the nine months ended September 30, 2025, up from $45.5 million in the same period of 2024, marking a $16.1 million increase [217]. - Accumulated deficit reached $1,218.1 million since inception, primarily due to research and development expenses and general administrative costs [218]. - Net cash used in operating activities was $252.6 million for the nine months ended September 30, 2025, compared to $159.0 million for the same period in 2024, reflecting an increase of $93.6 million [234][235]. - Net cash provided by investing activities was $301.9 million for the nine months ended September 30, 2025, primarily from net maturities of short-term investments [236]. - Net cash provided by financing activities was $20.8 million during the nine months ended September 30, 2025, compared to $422.2 million in the same period of 2024, a decrease of $401.4 million [237][238]. - Company expects existing cash and short-term investments of $490.9 million as of September 30, 2025, to fund operations for at least twelve months [220]. - The Hercules Loan and Security Agreement was amended to increase the term loan to up to $150 million, with a maturity date of October 1, 2026 [226][227]. - In October 2025, the Company entered into a Purchase and Sale Agreement with DRI for up to $300 million in consideration [230]. - The Company sold 11,425,000 shares in a public offering at $22.00 per share in October 2025, raising significant capital [232]. Market Environment - The global macroeconomic environment remains uncertain, with potential impacts from trade disputes, geopolitical instability, and inflationary pressures [192].