Eupraxia Pharmaceuticals Inc(EPRX)

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Eupraxia Pharmaceuticals Reports Second Quarter 2025 Financial Results and Provides Business Update
Globenewswire· 2025-08-12 20:25
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 ...
Eupraxia Pharmaceuticals Invited to Present at Upcoming Investor Conferences
Globenewswire· 2025-07-22 21:17
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].
Eupraxia Doses First Patient in Phase 2b Placebo-Controlled Portion of EP-104GI RESOLVE Trial in Eosinophilic Esophagitis
Globenewswire· 2025-07-08 11:00
Core Insights - Eupraxia Pharmaceuticals has initiated the Phase 2b randomized, placebo-controlled portion of the RESOLVE clinical trial for EP-104GI, targeting eosinophilic esophagitis (EoE) [1][4] - The trial aims to enroll at least 60 participants and will assess the efficacy of EP-104GI in improving tissue health and symptomatic relief [2][5] - The study employs an adaptive design for dose selection, with the first active dose being 120 mg based on previous cohorts' data [3][5] Company Overview - Eupraxia Pharmaceuticals is a clinical-stage biotechnology company focused on developing locally delivered, extended-release products for high unmet medical needs [10] - The company's proprietary DiffuSphere™ technology aims to optimize drug delivery, potentially reducing adverse events compared to traditional methods [10] - EP-104GI is administered via esophageal wall injections, representing a novel approach for treating EoE [11] Clinical Trial Details - The Phase 2b RESOLVE trial will evaluate two active doses of EP-104GI against a placebo over a 12-month period, with primary and secondary objectives including tissue health and symptom improvement [2][5][8] - Topline data from the Phase 2b study is expected by Q3 2026, with ongoing data reporting from the Phase 2a open-label study [7][5] - The trial will involve up to 25 sites globally, assessing various clinical outcomes at multiple time points [2][5] Eosinophilic Esophagitis (EoE) Context - EoE is an inflammatory condition affecting over 450,000 individuals in the U.S., characterized by difficulty swallowing and associated mental health issues [9] - The disease has been noted for its increasing incidence and prevalence, highlighting the need for effective treatments [9]
Eupraxia Pharmaceuticals to Host Virtual KOL Event to Discuss the Phase 1b/2a RESOLVE Study of EP-104GI for the Treatment of Eosinophilic Esophagitis (EoE) on May 9, 2025
Globenewswire· 2025-05-07 18:00
Core Viewpoint - Eupraxia Pharmaceuticals is hosting a virtual key opinion leader event to discuss clinical data from its Phase 1b/2a RESOLVE Study for EP-104GI, aimed at treating eosinophilic esophagitis (EoE) [1][2][3] Company Overview - Eupraxia Pharmaceuticals is a clinical-stage biotechnology company focused on developing locally delivered, extended-release products to address high unmet medical needs [7] - The company utilizes its proprietary DiffuSphere™ technology for optimized drug delivery, which aims to enhance safety, tolerability, efficacy, and duration of effect [7][8] Clinical Study Details - The RESOLVE trial is a Phase 1b/2a, multicenter, open-label, dose-escalation study evaluating the safety, tolerability, pharmacokinetics, and efficacy of EP-104GI in adults with active EoE [5] - EP-104GI is administered via esophageal wall injections, with patients evaluated for up to 52 weeks depending on the cohort [5] - Additional long-term data is expected to be released in Q3 2025 [5] Eosinophilic Esophagitis (EoE) Insights - EoE is an inflammatory disease affecting over 450,000 people in the U.S., characterized by white blood cells accumulating in the esophagus, leading to pain and swallowing difficulties [6] - The condition is rapidly increasing in incidence and prevalence, contributing to significant healthcare burdens and mental health issues for affected individuals [6] Expert Involvement - Dr. Evan Dellon, a leading expert in EoE, will participate in the KOL event to discuss the unmet needs and treatment landscape for EoE, alongside Eupraxia's CEO [2][3][4]
Eupraxia Pharmaceuticals Reports First Quarter 2025 Financial Results
Globenewswire· 2025-05-06 22:00
Core Insights - Eupraxia Pharmaceuticals has reported significant clinical milestones for its EP-104GI treatment for Eosinophilic Esophagitis (EoE), showing promising nine-month data from the Phase 1b/2a RESOLVE trial [2][8] - The company has a cash runway projected to fund operations until the third quarter of 2026, with current cash reserves of $27.5 million [5][6] Clinical Development - The RESOLVE trial indicates that a single treatment with a 48mg dose of EP-104GI leads to sustained or improved treatment outcomes over nine months, supporting its potential as a transformative therapy for EoE [2][8] - The company plans to advance into higher-dose cohorts in the upcoming quarters based on the positive results observed [2] Financial Performance - For Q1 2025, the company reported a net loss of $6.8 million, an increase from a net loss of $6.2 million in Q1 2024, primarily due to changes in research and development costs and general administrative expenses [4] - Cash reserves decreased from $33.1 million at the end of Q4 2024 to $27.5 million as of March 31, 2025, with funds allocated for clinical trials and general corporate purposes [5] Management and Operations - Alex Rothwell has been appointed as the new Chief Financial Officer, succeeding Bruce Cousins [8] - The company continues to monitor the impact of potential tariffs on its operations, particularly in light of recent trade announcements between the U.S. and Canada [7][10] Technology and Product Pipeline - Eupraxia's proprietary DiffuSphere™ technology is designed to optimize drug delivery, potentially improving the safety and efficacy of existing and novel drugs [12] - The company is also developing a pipeline of long-acting formulations targeting various therapeutic areas, including inflammatory joint conditions and oncology [13]
Eupraxia Pharmaceuticals Inc(EPRX) - 2025 Q1 - Quarterly Report
2025-05-06 20:59
Exhibit 99.1 EUPRAXIA PHARMACEUTICALS INC. CONSOLIDATED FINANCIAL STATEMENTS FOR THE THREE MONTHS ENDED MARCH 31, 2025 (Unaudited and Expressed in U.S. Dollars) EUPRAXIA PHARMACEUTICALS INC. INDEX TO CONSOLIDATED FINANCIAL STATEMENTS MARCH 31, 2025 and 2024 (Unaudited and Expressed in U.S. Dollars) CONTENTS | CONSOLIDATED BALANCE SHEETS | 2 | | --- | --- | | CONSOLIDATED STATEMENTS OF OPERATIONS AND COMPREHENSIVE LOSS | 3 | | CONSOLIDATED STATEMENTS OF CHANGES IN SHAREHOLDERS' EQUITY | 4-5 | | CONSOLIDATED ...
Eupraxia Pharmaceuticals Announces Sustained Positive Treatment Outcomes in Patients with Eosinophilic Esophagitis (EoE) After Nine Months of Receiving EP-104GI
Globenewswire· 2025-05-05 11:00
Core Insights - Eupraxia Pharmaceuticals announced positive outcomes from its RESOLVE Phase 1b/2a trial for EP-104GI, showing sustained or improved treatment results in all three patients after nine months of therapy [1][3][4] Company Overview - Eupraxia Pharmaceuticals is a clinical-stage biotechnology company focused on developing drug delivery systems for unmet medical needs, utilizing its proprietary DiffuSphere™ technology [16][17] - The company is currently evaluating EP-104GI for eosinophilic esophagitis (EoE), a chronic inflammatory condition affecting the esophagus [1][15] Trial Details - The RESOLVE trial is a multi-center, open-label, dose-escalation study assessing the safety, tolerability, pharmacokinetics, and efficacy of EP-104GI in adults with active EoE [12] - Cohort 5 data revealed that patients receiving 48 mg of EP-104GI showed significant improvements in symptom severity, tissue health, and eosinophil counts after nine months [3][4][5] Key Findings - Symptom Improvement: Patients reported an average reduction of 3.7 points (65%) on the Straumann Dysphagia Index (SDI) after nine months [4][6] - Tissue Health: There was a 56% average reduction in EoEHSS Stage score and a 45% reduction in Grade score [4][5] - Eosinophil Reduction: A mean decrease of 77% in eosinophil counts was observed, with a 52% remission rate across biopsy sites [5][6] Future Plans - Additional long-term data with higher doses is expected to be released in Q3 2025 [3][13] - The company will host a webinar on May 9, 2025, to discuss the RESOLVE trial data [11]
Eupraxia Pharmaceuticals to Present at Investor and Scientific Conferences in April and May
Newsfilter· 2025-04-24 21:00
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].
Eupraxia Pharmaceuticals Reports Fourth Quarter 2024 Financial Results
Prnewswire· 2025-03-20 21:31
Core Insights - Eupraxia Pharmaceuticals Inc. reported financial results for Q4 2024, highlighting a net loss reduction and successful clinical trial data for its product EP-104GI [1][4][2] Financial Performance - The company incurred a net loss of $7.5 million in Q4 2024, an improvement from a net loss of $10.6 million in Q4 2023, attributed to lower research and development costs and reduced expenses [4] - Cash reserves increased to $33.1 million as of December 31, 2024, up from $19.3 million at the end of Q4 2023, providing sufficient funding for clinical trials and operational needs into Q3 2026 [5] Clinical Developments - Positive data from the Phase 1b/2a RESOLVE trial for EP-104GI indicated improved tissue health and symptom reduction in eosinophilic esophagitis patients, with higher doses showing better outcomes [2][13] - The company also completed a Phase 2b trial (SPRINGBOARD) for EP-104IAR, which met its primary endpoint and three of four secondary endpoints [13] Operational Highlights - The appointment of Dr. Amanda Malone as Chief Operating and Scientific Officer was announced, along with the return of Alex Rothwell as Chief Financial Officer [6] - The company presented significant trial data at various medical conferences, receiving accolades for its research quality [6] Market and Trade Considerations - Management is monitoring the potential impact of proposed tariffs on Canadian goods by the U.S. government and retaliatory tariffs from Canada, assessing their implications for the company's operations [8][10] - Eupraxia sources its active pharmaceutical ingredients from the U.S. and maintains U.S. dollar balances to mitigate exchange rate fluctuations [9]
Eupraxia Pharmaceuticals Announces Positive Data from RESOLVE Phase 1b/2a Trial of EP-104GI for Treatment of Eosinophilic Esophagitis
Prnewswire· 2025-02-25 12:00
Core Insights - Eupraxia Pharmaceuticals announced positive clinical data from its ongoing RESOLVE Phase 1b/2a trial for EP-104GI, aimed at treating eosinophilic esophagitis (EoE) [1][3] - The trial has shown improvements in both tissue health and symptom relief, with no serious adverse events reported [3][5] Company Overview - Eupraxia Pharmaceuticals is a clinical-stage biotechnology company focused on precision local drug delivery, particularly for conditions with high unmet medical needs [14][15] - The company utilizes its proprietary DiffuSphere™ technology to facilitate targeted drug delivery, aiming to improve safety and efficacy compared to traditional methods [14] Clinical Trial Details - The RESOLVE trial is a multi-center, open-label, dose-escalation study evaluating the safety and efficacy of EP-104GI in adults with active EoE [9] - Cohort 6 of the trial received 16 injections of 4 mg EP-104GI, targeting the lower three-quarters of the esophagus, resulting in significant improvements in symptom relief and tissue health [4][5] Key Findings from the RESOLVE Trial - Cohort 6 demonstrated the highest symptom relief scores (SDI) and the greatest improvement in tissue health scores (EoEHSS) to date [5][6] - A mean reduction of 94% in peak eosinophil counts (PEC) was observed, with a 62% remission rate across biopsy sites [6][8] - No serious adverse events or cases of oral or gastrointestinal candidiasis were reported in any of the cohorts [5][6] Future Expectations - Cohort 7 is fully enrolled, with 12-week data expected in late Q2 2025 [10] - The company plans to explore higher dosing levels and expanded esophageal coverage in future cohorts based on the positive outcomes observed [3][5]