Core Insights - Immunic Inc's CEO Dr. Daniel Vitt highlighted the promising results from the Phase 2 CALLIPER trial of vidofludimus calcium, showing a 24% reduction in disability progression across the full study population, with over 30% reduction in patients with primary progressive MS [1][2]. Clinical Progress - The CALLIPER study aimed to analyze the neuroprotective effect of vidofludimus calcium in patients with progressive forms of multiple sclerosis, addressing a significant unmet medical need [2]. - The CALLIPER data is deemed important for various forms of MS, including primary progressive, secondary progressive, and relapsing MS, with ongoing Phase 3 ENSURE studies expected to benefit from the drug's neuroprotective features [3]. Trial Enrollment and Milestones - The company completed enrollment for both ENSURE trials, involving a total of 2,200 patients, marking a significant milestone in the quarter [4]. - The trials are set to read out next year, indicating a step closer to potential new treatment options for patients with relapsing MS [4]. EMPhASIS Trial Results - New data from the Phase 2 EMPhASIS trial indicated that over 90% of patients treated with vidofludimus calcium for 144 weeks were free of disability progression, showcasing the drug's effectiveness [6]. Financial Position - The company strengthened its balance sheet through two financings, positioning itself well to advance its clinical trials, particularly the Phase 3 studies in relapsing MS [7][8].

Core Insights - Immunic, Inc. has made significant clinical advancements with its lead asset, vidofludimus calcium, particularly in multiple sclerosis treatment, showing promising results in various trials [2][11] - The company has completed enrollment for its phase 3 ENSURE trials, with top-line data expected by the end of 2026, indicating progress towards a potential new treatment option for relapsing multiple sclerosis [2][11] - Financially, Immunic has strengthened its balance sheet with two financings totaling $70.1 million in gross proceeds, although it reported a net loss of approximately $27 million for the second quarter of 2025 [6][9] Clinical Developments - The phase 2 CALLIPER trial demonstrated a 23.8% reduction in time to 24-week confirmed disability worsening in the overall progressive multiple sclerosis population compared to placebo, with even higher reductions in specific subgroups [2][7] - Long-term open-label extension data from the phase 2 EMPhASIS trial showed that 92.3% of patients remained free of 12-week confirmed disability worsening at week 144, reinforcing the drug's efficacy [2][6] - Vidofludimus calcium's neuroprotective effects are believed to be mediated through activation of the Nurr1 target, which may address the complex pathophysiology of multiple sclerosis [2][11] Financial Performance - Research and Development (R&D) expenses for the second quarter of 2025 were $21.4 million, an increase from $18.3 million in the same period of 2024, primarily due to higher external development costs related to vidofludimus calcium [6][8] - General and Administrative (G&A) expenses also increased to $5.7 million for the second quarter of 2025, compared to $4.5 million in the prior year [8] - The company reported a net loss of approximately $27 million for the second quarter of 2025, with a net loss per share of $0.20, reflecting a slight improvement from a net loss of $21.4 million in the same quarter of 2024 [9][14] Market Potential - The market for primary progressive multiple sclerosis is estimated to exceed $6 billion, with vidofludimus calcium positioned as a promising treatment option in this underserved area [2][11] - The company is also preparing for further clinical testing of IMU-856, which targets gastrointestinal disorders and may offer a novel therapeutic approach [3][4]

Financial Data and Key Metrics Changes - Total revenue for Q2 2025 was reported at $141.1 million, which includes U.S. net product revenue of $138.8 million, representing a 91% increase compared to the same period last year and a 16% growth over Q1 2025 [21][22] - GAAP net income for the quarter was $28.2 million, or $0.17 per diluted share, compared to $6.9 million, or $0.04 per diluted share, for Q2 2024 [23] Business Line Data and Key Metrics Changes - The flagship product, BREONVY, generated net sales of approximately $139 million in Q2 2025, exceeding internal expectations and building on robust growth from Q1 [14] - The adoption rate of BREONVY is estimated at nearly one in every three new IV anti-CD20 patients, indicating significant market penetration [7] Market Data and Key Metrics Changes - The CD20 class generates over $8 billion in annual U.S. MS sales, with BREONVY steadily increasing its market share within this expanding market [15] - The company is focused on expanding its addressable market by developing a subcutaneous formulation of BREONVY, which could unlock access to 35% to 40% of the anti-CD20 market segment that prefers self-administered options [8] Company Strategy and Development Direction - The company aims to position BREONVY as the most prescribed anti-CD20 therapy for relapsing MS, with ongoing efforts to enhance patient experience and expand treatment options [6][11] - A national television campaign has been launched to increase patient awareness, with early signs indicating a positive impact on brand recognition [16][17] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in continued growth for BREONVY, raising full-year U.S. revenue guidance to $560 million to $575 million for 2025 [19] - The company anticipates stronger growth from Q3 to Q4, accounting for seasonal trends and increased patient enrollments [27] Other Important Information - The company reported total operating expenses of approximately $71 million for Q2 2025, an increase from $46.9 million in 2024, driven by R&D investments [22][23] - The company closed the quarter with approximately $279 million in cash and equivalents, maintaining a strong capital position for future investments [24] Q&A Session Summary Question: Guidance and Growth Expectations - Management acknowledged seasonality in summer and expects stronger growth from Q3 to Q4, which is reflected in the raised guidance [26][27] Question: Market Dynamics and Competitors - The company captures about one-third of the IV segment, with competitors sharing the remaining market [31] - There are no current signs of demand for subcutaneous options outpacing IV, but the company is actively developing its own subcutaneous formulation [32] Question: Subcutaneous Product Development - The subcutaneous product will initially be tested with a syringe from a vial, followed by a bridging study to an auto-injector [36] Question: Revenue Guidance and Market Trends - Management noted that the overall IV market is stable, with limited enthusiasm for competitor products [43][44] Question: Product Adherence and Q3 Guidance - The company did not provide specific Q3 guidance but indicated strong persistence rates for BREONVY [54][55]

Financial Data and Key Metrics Changes - Total revenue for Q2 2025 was reported at $141.1 million, which includes U.S. net product revenue of $138.8 million, representing a 91% increase compared to the same period last year and a 16% growth over Q1 2025 [21][22] - GAAP net income for the quarter was $28.2 million, or $0.17 per diluted share, compared to $6.9 million, or $0.04 per diluted share, for Q2 2024 [23] Business Line Data and Key Metrics Changes - U.S. net sales for BREONVY in Q2 totaled approximately $139 million, exceeding internal expectations and building on robust growth from Q1 [14] - The adoption of BREONVY continues to grow, with nearly one in every three new IV anti-CD20 patients being prescribed BREONVY [6][15] Market Data and Key Metrics Changes - The CD20 class generates over $8 billion in annual U.S. MS sales and continues to grow, with BREONVY steadily increasing its market share [15] - The company estimates that approximately 35% to 40% of the anti-CD20 dynamic market segment currently prefers a self-administered option [7] Company Strategy and Development Direction - The company is focused on expanding choice and flexibility for patients through the development of subcutaneous BREONVY, which is expected to significantly expand the addressable market [7][8] - The strategic plan includes initiating patient enrollment into a pivotal Phase III trial for subcutaneous BREONVY in the coming weeks, with a BLA filing anticipated in 2027 and a potential launch in 2028 [9][10] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the continued growth of BREONVY revenues, raising full-year U.S. net revenue guidance to $560 million to $575 million for 2025 [19] - The management highlighted strong execution across commercial and clinical fronts, with a growing confidence in BREONVY from both physicians and patients [11] Other Important Information - The company reported total operating expenses of approximately $71 million for Q2 2025, an increase from $46.9 million in 2024, driven by ongoing investments in R&D [22][23] - The company closed the quarter with approximately $279 million in cash and cash equivalents, maintaining a strong capital position for future investments [24] Q&A Session Summary Question: Guidance and Growth Expectations - The management acknowledged seasonality in summer and expects stronger growth from Q3 to Q4, which is reflected in the raised guidance [26][27] Question: Market Share and Competitors - The company captures about one-third of the IV segment, with the remaining market share divided among competitors [31] Question: Subcutaneous Product Development - The subcutaneous product will start with injections from a vial, followed by a bridging study to an auto-injector, with a target filing in 2027 and approval in 2028 [36][37] Question: Revenue Guidance and Market Trends - The management noted that they are not seeing significant impact from competitors and that the overall market for IV therapies is stable [42][43] Question: Product Adherence and Q3 Guidance - The company did not provide specific Q3 guidance but indicated strong persistence rates for patients on BREONVY [53][56] Question: Subcutaneous Dosing and Volume - Preliminary bioavailability information suggests that both every other month and quarterly dosing are achievable for the subcutaneous product [60]

Core Insights - Immunic, Inc. reported long-term data from the phase 2 EMPhASIS trial of vidofludimus calcium, showing 92.3% of patients remained free of 12-week confirmed disability worsening (CDW) and 92.7% free of 24-week CDW at week 144 [1][3] - The drug demonstrated a favorable safety and tolerability profile, with no new safety signals emerging during treatment durations of up to 5.5 years [1][3] Group 1: Clinical Trial Data - The phase 2 EMPhASIS trial included 268 patients with relapsing-remitting multiple sclerosis (RRMS), achieving both primary and key secondary endpoints with high statistical significance [4] - A total of 29 CDW events were confirmed at 12 weeks, with 44.8% associated with relapse-associated worsening (RAW) and 13.8% with progression independent of relapse activity (PIRA) [3] - The open-label extension (OLE) period provided approximately 952 treatment years of data, reinforcing the drug's safety and tolerability [2][3] Group 2: Drug Mechanism and Potential - Vidofludimus calcium is a first-in-class nuclear receptor-related 1 (Nurr1) activator, combining neuroprotective, anti-inflammatory, and anti-viral effects [6][7] - The drug has shown therapeutic activity in both relapsing-remitting and progressive multiple sclerosis patients, significantly reducing brain lesions and confirmed disability worsening [6][7] - The ongoing phase 3 clinical trials aim to further evaluate the drug's efficacy and safety, with top-line data expected by the end of 2026 [7]

Summary of Immunic (IMUX) Conference Call Company Overview - **Company**: Immunic (IMUX) - **Focus**: Clinical stage company developing oral treatments for chronic inflammation and autoimmune diseases, particularly multiple sclerosis (MS) [2][3] Key Points on Multiple Sclerosis (MS) Treatment - **Market Opportunity**: Immunic targets a significant commercial opportunity with peak sales potential estimated between $3 billion to $7 billion across various forms of MS [3][9] - **Pipeline**: - **Beta Frutimous Calcium**: In phase three for relapsing MS (RMS) and recently completed phase two for progressive MS (PMS) [3][9] - **IMU 856**: Targeting gastrointestinal diseases, specifically celiac disease [4][26] Beta Frutimous Calcium - **Mechanism of Action**: - Acts as a potent inhibitor of DHODH, reducing inflammation and preventing neurodegeneration [4][5] - Activates NurOwn, a nuclear receptor that protects neurons from cell death [5][10] - **Clinical Data**: - Phase two study (EMPHASIS) showed a 76% reduction in active lesions and a 94.2% rate of patients free from confirmed disability worsening after two years [12][13] - Phase two study (CALIPER) demonstrated a 24% reduction in confirmed disability worsening overall, with 33% in primary progressive MS (PPMS) patients [19][20] - Notably effective in patients without active inflammation, showing a 34% reduction in disability worsening [22][24] Unmet Medical Need - **Current Treatments**: Only one drug approved for primary progressive MS, highlighting a significant unmet need in the market [16][15] - **Patient Population**: Approximately 1.2 million eligible patients for MS treatment globally, with many not currently receiving therapy [8][16] Key Points on IMU 856 - **Mechanism**: A selective modulator targeting epithelial regeneration in the gut, potentially applicable to various gastrointestinal disorders [26][28] - **Clinical Data**: - Phase one study showed a significant increase in GLP-1 levels (up to 250%) in celiac disease patients, indicating potential for managing weight gain and gut health [31][32] - Demonstrated protection of gut villi and improved nutrient absorption in a short-term study [35][36] Safety and Tolerability - **Beta Frutimous Calcium**: Favorable safety profile with no new safety findings reported, making it an attractive option for newly diagnosed MS patients [23][14] - **IMU 856**: Safety and tolerability assessed in clinical studies, with promising results [30][34] Future Outlook - **Next Steps**: Anticipation of top-line data from phase three studies by the end of 2026, with potential NDA submission in 2027 if results are positive [25][37] - **Market Positioning**: Immunic aims to position Beta Frutimous Calcium as a unique oral treatment option for all forms of MS, addressing both relapsing and progressive forms [37]

Core Insights - Immunic, Inc. has completed enrollment for both Phase 3 ENSURE trials of vidofludimus calcium in patients with relapsing multiple sclerosis (RMS), with top-line data expected by the end of 2026 [1][3] - Additional data from the Phase 2 CALLIPER trial in progressive multiple sclerosis (PMS) supports the positive results previously released, highlighting the neuroprotective potential of vidofludimus calcium [1][4] Group 1: ENSURE Trials - The ENSURE program consists of two identical multicenter, randomized, double-blind Phase 3 trials aimed at evaluating the efficacy, safety, and tolerability of vidofludimus calcium versus placebo in RMS patients [2] - A total of 1,121 patients were enrolled in ENSURE-1 and 1,100 patients in ENSURE-2, with the primary endpoint being the time to first relapse over 72 weeks [2] - Secondary endpoints include time to confirmed disability worsening, volume of new T2 lesions, and MRI-based endpoints [2] Group 2: CALLIPER Trial Data - In the Phase 2 CALLIPER trial, vidofludimus calcium demonstrated a 24% reduction in the hazard ratio for 24-week confirmed disability worsening (24wCDW) compared to placebo [5] - The drug showed a 33% reduction in 24wCDW in primary progressive multiple sclerosis (PPMS) patients, a 19% reduction in non-active secondary progressive multiple sclerosis (naSPMS), and a 34% reduction in active secondary progressive multiple sclerosis (aSPMS) [5] - For patients without evidence of gadolinium-enhancing lesions at baseline, vidofludimus calcium reduced 24wCDW by 34% compared to placebo [5][6] Group 3: Vidofludimus Calcium Overview - Vidofludimus calcium is an investigational oral small molecule drug targeting chronic inflammatory and autoimmune diseases, currently in late-stage clinical trials for multiple sclerosis [7] - The drug acts as a selective immune modulator, activating the neuroprotective transcription factor Nurr1 and inhibiting dihydroorotate dehydrogenase (DHODH) to provide neuroprotective, anti-inflammatory, and anti-viral effects [7] - The drug has been tested in approximately 2,700 individuals, showing an attractive pharmacokinetic, safety, and tolerability profile [7]

Core Insights - TG Therapeutics presented data on BRIUMVI® (ublituximab-xiiy) for relapsing forms of multiple sclerosis (RMS) at the 2025 Consortium of Multiple Sclerosis Centers (CMSC) annual meeting [1][2] - The company is optimistic about the ongoing data presentations throughout the year [2] Company Overview - TG Therapeutics is a biopharmaceutical company focused on developing treatments for B-cell diseases, with BRIUMVI approved for RMS treatment in the U.S., Europe, and the UK [23] - The company has a pipeline of investigational medicines in addition to BRIUMVI [23] Product Information - BRIUMVI is a monoclonal antibody targeting CD20-expressing B-cells, designed to deplete B-cells efficiently at low doses through glycoengineering [4] - It is indicated for adults with RMS, including clinically isolated syndrome, relapsing-remitting disease, and active secondary progressive disease [5] Clinical Trials - The ULTIMATE I & II trials involved 1,094 RMS patients across 10 countries, comparing BRIUMVI to teriflunomide over 96 weeks [3] - The trials required patients to have experienced at least one relapse in the previous year or two relapses in the previous two years, with specific EDSS score criteria [3] Safety and Efficacy Data - Presentations at the CMSC included findings on the safety and tolerability of BRIUMVI, with a focus on infusion reactions and immunoglobulin levels [2][6] - The incidence of infusion reactions in BRIUMVI-treated patients was reported at 48%, with serious reactions occurring in 0.6% of patients [6][8] - The overall infection rate in BRIUMVI-treated patients was 56%, with serious infections at 5% [8] Market Context - Relapsing multiple sclerosis affects nearly 1 million people in the U.S., with 85% initially diagnosed with relapsing-remitting forms [22] - The global prevalence of MS is over 2.3 million [22]

Financial Data and Key Metrics Changes - U.S. net product revenue for Q1 2025 was approximately $119.7 million, reflecting a 137% increase year-over-year and a 16% increase sequentially from Q4 2024 [14][23] - GAAP net income for the quarter was approximately $5 million, or $0.03 per diluted share [24] - The company closed the quarter with $276 million in cash, cash equivalents, and investment securities, indicating a strong financial position [24] Business Line Data and Key Metrics Changes - BRIONVI U.S. net sales reached nearly $120 million in Q1 2025, exceeding expectations and demonstrating strong adoption by healthcare providers [5][14] - The first three months of 2025 marked the highest total new patient enrollment since the product launch, indicating accelerating demand [15] - Repeat prescriptions have now surpassed new prescriptions for the first time, signaling strong persistence trends [17] Market Data and Key Metrics Changes - The company is capturing approximately 25% of the IV segment market share, with continued growth in patient enrollments [29] - The hospital setting contributed approximately 60% of enrollments in March, the highest percentage to date [16] Company Strategy and Development Direction - The company aims to make BRIONVI the number one prescribed anti-CD20 therapy by focusing on a multi-phase launch strategy and enhancing the patient experience [8][12] - Plans include launching a direct-to-patient television commercial campaign and preparing for lifecycle innovations, including a subcutaneous formulation [19][21] - The company is also exploring new indications for BRIONVI, such as myasthenia gravis, while advancing its CAR T cell therapy pipeline [11][12] Management's Comments on Operating Environment and Future Outlook - Management expressed optimism about continued growth and potential for BRIONVI, citing strong demand and increasing prescriber confidence [20][21] - The company is monitoring potential tariffs but does not anticipate a material impact on gross margins or overall financial performance [26] Other Important Information - The ENHANCE clinical trial is evaluating strategies to simplify the patient experience, with positive feedback on a streamlined infusion regimen [9][10] - The company is on track to launch pivotal trials for both the simplified starting dose and the subcutaneous formulation of BREONVY [52][68] Q&A Session Summary Question: Competitive dynamics with OCREVUS and new patient share - Management noted strong patient enrollments and market share gains, with no impact from OCREVUS observed [29][30] Question: Update on gross to net trends and gross margin - No material change in gross to net was reported, and the pre-launch inventory reserve has been fully depleted, leading to consistent margins going forward [37][38] Question: Subcutaneous BREONVY pivotal trial details - The pivotal trial is expected to include two dosing regimens, with data anticipated later this year [41][42] Question: Physician feedback on the thirty-minute infusion - Positive feedback was received, indicating convenience for infusion centers and patients [49] Question: Phase III trial scale and profitability outlook - The company is not focused on profitability this year but aims to drive cash through the business while meeting revenue targets [54][55] Question: Update on North Carolina manufacturing plant - The North Carolina facility will take several years to reach commercial scale manufacturing [57][58] Question: Product adherence and trends - Persistence trends remain strong and above expectations, with no material changes in switch rates from OCREVUS [63][71]

Financial Performance - TG Therapeutics reported U.S. net revenue of $119.7 million for BRIUMVI in the first quarter of 2025, representing approximately 137% growth compared to the same period last year [5][9] - The company raised its full-year 2025 global net revenue target to approximately $575 million, up from a prior guidance of $540 million, and increased the U.S. net revenue target for BRIUMVI to approximately $560 million from $525 million [1][10] - The net income for the first quarter of 2025 was $5.1 million, compared to a net loss of $10.7 million for the same period in 2024 [9][41] Product Development and Commercialization - BRIUMVI is experiencing growing adoption among healthcare providers, with positive feedback from both patients and clinicians, reinforcing the company's goal of making BRIUMVI the number one prescribed anti-CD20 treatment [2][5] - The company is investing in innovation, including simplifying the BRIUMVI treatment regimen and advancing subcutaneous BRIUMVI [2][5] - BRIUMVI is now commercially available in additional countries in the European Union, United Kingdom, and Switzerland, expanding its market presence [5][10] Clinical Trials and Research - Five-year data from the ULTIMATE I & II Phase 3 clinical trials showed that 92% of patients were free from disability progression after five years of treatment with BRIUMVI [5] - Ongoing clinical trials include a Phase 1 trial evaluating subcutaneous BRIUMVI and another for azer-cel in patients with primary progressive multiple sclerosis [6][10] - The ENHANCE Phase 3b clinical trial demonstrated that a single 600 mg BRIUMVI infusion was well tolerated, and rapid 30-minute infusions were also well received by patients [5][10] Financial Guidance and Future Outlook - The company anticipates a second quarter 2025 U.S. net product revenue target of $135 million and expects total operating expenses for the full year 2025 to be approximately $300 million [10][41] - TG Therapeutics plans to commence pivotal programs for subcutaneous BRIUMVI and based on improved dosing regimens evaluated in the ENHANCE trial [10][41] - The company aims to continue enrollment in ongoing clinical trials for BRIUMVI in autoimmune diseases outside of multiple sclerosis [10][41]