Announced first patient dosed in the Phase 2b placebo-controlled portion of the EP-104GI RESOLVE trial with topline data expected in H2 2026Announced positive data from Phase 1b/2a RESOLVE supporting the potential of EP-104GI to improve the standard of care for patients with Eosinophilic Esophagitis (“EoE”)Additional data from cohorts 5–8 from Phase 1b/2a available in October 2025 VICTORIA, British Columbia, Aug. 12, 2025 (GLOBE NEWSWIRE) -- Eupraxia Pharmaceuticals Inc. (“Eupraxia” or the “Company”) (NASDA ...

Financial Data and Key Metrics Changes - Total revenue for Q2 2025 was $326 million, representing a 41% increase year-over-year [5][35] - Royalty revenue grew 65% year-over-year to $206 million, driven by strong performance from established therapies [6][37] - Adjusted EBITDA increased 65% to $226 million compared to $137 million in the prior year [6][39] - Full-year revenue guidance for 2025 was raised to $1.275 billion to $1.355 billion, reflecting 26% to 33% growth over 2024 [6][41] Business Line Data and Key Metrics Changes - The three established blockbuster therapies driving growth are Darzalex subcutaneous, FSGO, and Vyvgart Hytrulo [5][10] - Darzalex revenue increased almost 22% to $3.5 billion in Q2 2025, with a 96% conversion rate to subcutaneous delivery in the U.S. [12][13] - FSGO revenue for the first half of 2025 was approximately $1.5 billion, reflecting a 55% year-over-year growth [16] - Vyvgart Hytrulo sales increased 97% year-over-year to $949 million in Q2 2025 [18] Market Data and Key Metrics Changes - The U.S. market for Darzalex subcutaneous is projected to continue strong growth due to increased penetration in frontline settings [12][13] - The total addressable market for generalized myasthenia gravis in the U.S. is now estimated at 60,000 patients, significantly higher than initial estimates [19] - Analysts project total brand sales for Ocrevus to reach $10 billion by 2028, with Halozyme earning royalties on the subcutaneous formulation [24] Company Strategy and Development Direction - The company is focusing on identifying new drug delivery platforms that can generate long-term revenue streams through royalties [7] - There is an emphasis on expanding the use of subcutaneous delivery systems to improve patient access and convenience [10][19] - The company is actively pursuing M&A opportunities while maintaining a disciplined approach to leverage [7][36] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the durability of revenue streams and the potential for continued growth driven by multiple catalysts [43] - The company is optimistic about the regulatory environment and believes it will prevail in ongoing litigation with Merck [52] - Management highlighted the importance of the IRA and ongoing discussions with CMS regarding the impact on their products [55] Other Important Information - The company completed a $250 million share repurchase in Q2 2025 and initiated a third tranche under a $750 million plan [7][36] - The company maintains a strong balance sheet with cash and marketable securities of $548.2 million as of June 30, 2025 [40] Q&A Session Summary Question: Status of IP litigation with Merck - The company is suing Merck for infringing 15 of its patents and expects to receive a scheduling order from the court in the coming months [46][48] Question: Confidence in regulatory front - Management is confident that there will be no impactful changes from CMS regarding the IRA and has submitted arguments to support this [55][56] Question: Guidance setting process - The company uses trends and inputs from partners to set guidance, with a focus on the latest data points [58][59] Question: Interest in high-volume auto injectors - There is strong interest from multiple companies in the high-volume auto injectors, with ongoing discussions at various stages [69][70] Question: Long-term guidance updates - The company updates long-term guidance annually, with more information expected at the start of the next year [66]

Core Viewpoint - Eupraxia Pharmaceuticals Inc. is a clinical-stage biotechnology company focused on optimizing local, controlled drug delivery through its proprietary DiffuSphere™ technology, addressing significant unmet medical needs in various therapeutic areas [1][3]. Company Overview - Eupraxia is developing locally delivered, extended-release products aimed at therapeutic areas with high unmet medical need, utilizing its DiffuSphere™ technology for targeted drug delivery [3]. - The technology is designed to enhance the safety, tolerability, efficacy, and duration of effect of existing FDA-approved drugs, with potential applications extending beyond pain and inflammatory gastrointestinal diseases to oncology and infectious diseases [3]. Clinical Trials and Pipeline - Eupraxia's EP-104GI is currently in a Phase 1b/2 trial (RESOLVE trial) for treating eosinophilic esophagitis (EoE), utilizing a unique injection method for local drug delivery [4]. - The company recently completed a Phase 2b clinical trial (SPRINGBOARD) for EP-104IAR, targeting pain from knee osteoarthritis, achieving its primary endpoint and three of four secondary endpoints [4]. - Eupraxia is also developing a pipeline of long-acting formulations for other inflammatory joint conditions and oncology, aimed at improving the activity and tolerability of currently approved drugs [4]. Upcoming Investor Conferences - Eupraxia's management will present at several upcoming investor conferences, including: - Canaccord Growth 45th Annual Growth Conference on August 13, 2025, in Boston, MA [2]. - Citi Biopharma Back to School Conference on September 2-3, 2025, in Boston, MA [2]. - Cantor Global Healthcare Conference on September 5, 2025, in New York, NY [2]. - H.C. Wainwright 27th Annual Global Investment Conference on September 8-10, 2025, in New York, NY [2].

Core Viewpoint - Eupraxia Pharmaceuticals Inc. is actively participating in multiple upcoming investor and scientific conferences to present its clinical data and advancements in drug delivery technology, particularly focusing on its proprietary DiffuSphere™ technology and ongoing clinical trials for its product candidates [1][9]. Conference Presentations - The company will present at the Osteoarthritis Research Society International World Congress from April 24-27, 2025, with a poster on EP-104IAR, highlighting sustained pain response in knee osteoarthritis patients [2][3]. - At the Digestive Disease Week Annual Meeting from May 3-6, 2025, data from the Phase 1b study of EP-104GI for eosinophilic esophagitis will be presented, including results from the ongoing RESOLVE trial [4][5]. - The CEO will present at the Bloom Burton & Co. Healthcare Investor Conference on May 5, 2025, and participate in investor meetings [5][6]. Product Development - Eupraxia's EP-104GI is in a Phase 1b/2a trial for eosinophilic esophagitis, utilizing a unique local delivery method via injection into the esophageal wall [10]. - The company recently completed a Phase 2b clinical trial (SPRINGBOARD) for EP-104IAR, which met its primary endpoint and three of four secondary endpoints, indicating potential for effective treatment in knee osteoarthritis [10]. Technology Overview - The DiffuSphere™ technology is designed for targeted drug delivery, aiming to improve the safety, tolerability, efficacy, and duration of effect of existing and novel drugs, with applications extending beyond pain and inflammatory gastrointestinal diseases to oncology and infectious diseases [9][10].