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Eupraxia Pharmaceuticals Reports Third Quarter 2025 Financial Results
Globenewswire· 2025-11-04 21:39
Core Insights - Eupraxia Pharmaceuticals reported durable symptom and tissue responses for EP-104GI, with data observed up to 52 weeks following a single treatment, indicating its potential as an effective treatment for eosinophilic esophagitis (EoE) [1][2] - The company completed a public offering raising $80.5 million, which will support the advancement of the EP-104GI program and other pipeline developments [4][2] - The company has sufficient cash reserves to fund operations and pipeline development into the first half of 2028, with cash on hand reported at $89.0 million as of September 30, 2025 [6][7] Clinical Trial Updates - The Phase 1b/2a RESOLVE Trial showed that two-thirds of patients in Cohort 5 remained in clinical remission after treatment with EP-104GI, demonstrating long-term disease control [3] - The highest-dose cohort in the RESOLVE trial exhibited the largest improvements in tissue health outcomes and eosinophil reduction, with no additional safety concerns reported [2] Financial Performance - For Q3 2025, the company incurred a net loss of $6.4 million, slightly higher than the $6.0 million loss in Q3 2024, primarily due to increased research and development costs [5] - The company’s cash position improved significantly from $33.1 million at the end of Q4 2024 to $89.0 million as of September 30, 2025, allowing for continued funding of clinical trials and operational needs [6] Market and Operational Considerations - The company is monitoring the potential impacts of proposed tariffs on Canadian goods by the U.S. government and retaliatory tariffs by Canada, which could affect its operations [8][10] - Eupraxia manufactures its clinical supplies in the U.S. and maintains U.S. dollar balances to mitigate the impact of exchange rate fluctuations [9]
Eupraxia Pharmaceuticals Announces Positive Data from Highest-Dose Cohort in the Ongoing RESOLVE Trial in Eosinophilic Esophagitis, and Plans for Expansion of EP-104GI Development Programs
Globenewswire· 2025-09-29 21:00
Core Insights - Eupraxia Pharmaceuticals Inc. has provided an operational update on the development of EP-104GI, reporting data from Cohort 9 of the RESOLVE trial, where patients received an 8mg dose per injection for the first time [1][2] Clinical Trial Results - Cohort 9 demonstrated the largest improvements in tissue health outcomes and eosinophil reduction to date, with no serious adverse events reported [5][6] - The RESOLVE Safety Committee endorsed the 8mg dose as the second dose for the ongoing Phase 2b study, indicating strong confidence in the dosing strategy [5][6] - The company plans to expand the Phase 2b study from 60 to at least 120 patients, enhancing the statistical power and safety database [8][13] Future Plans - Eupraxia intends to initiate a clinical trial for an additional gastrointestinal indication in the first half of 2026, leveraging recent financing to support this expansion [5][8] - The company aims to disclose additional data from the RESOLVE trial in Q4 2025 and expects top-line data from the Phase 2b trial in Q3 2026 [9][16] Technology and Market Potential - EP-104GI utilizes Eupraxia's proprietary Diffusphere™ technology for localized drug delivery, which may improve safety and efficacy compared to traditional methods [15][16] - Eosinophilic Esophagitis (EoE) affects over 450,000 people in the U.S., indicating a significant market opportunity for effective treatments [11][16]
Eupraxia Pharmaceuticals Announces Closing of US$80.5 Million Public Offering Including Full Exercise of Underwriter Option
Globenewswire· 2025-09-24 12:54
Core Viewpoint - Eupraxia Pharmaceuticals has successfully closed a public offering of 14,636,363 common shares at a price of US$5.50 per share, raising approximately US$80.5 million in gross proceeds, which will be used to advance its product pipeline and support key clinical and regulatory milestones [1][2][3] Group 1: Offering Details - The public offering included the full exercise of the underwriters' option to purchase additional shares [1] - The offering was conducted under a U.S. registration statement declared effective by the SEC and the existing Canadian short form base shelf prospectus [4] Group 2: Use of Proceeds - The net proceeds from the offering will primarily fund the advancement of the product pipeline, including ongoing preclinical studies, clinical trials, regulatory submissions, and commercial preparation [3] - Additional allocations will support research and development of new pipeline candidates, business development initiatives, and general corporate purposes [3] Group 3: Company Background - 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 local drug delivery [7]
Eupraxia Pharmaceuticals Announces Pricing of US$70 Million Public Offering of Common Shares
Globenewswire· 2025-09-23 02:42
Core Viewpoint - Eupraxia Pharmaceuticals Inc. has announced a public offering of 12,727,273 common shares at a price of US$5.50 per share, aiming to raise approximately US$70 million for advancing its product pipeline and other corporate purposes [1][3] Group 1: Offering Details - The offering consists of 12,727,273 common shares priced at US$5.50 each, with gross proceeds expected to be around US$70 million before expenses [1] - Underwriters have a 30-day option to purchase an additional 1,909,090 common shares under the same terms [1] - The offering is set to close on September 24, 2025, pending customary closing conditions [1] Group 2: Use of Proceeds - The net proceeds will primarily fund the advancement of the product pipeline, including ongoing preclinical studies, clinical trials, regulatory submissions, and commercial preparation [3] - Additional allocations will support research and development of new pipeline candidates, business development initiatives, and general corporate purposes [3] - The company may also invest in expanding its intellectual property portfolio and enhancing corporate infrastructure for future growth [3] Group 3: Regulatory and Compliance - The offering is made under a U.S. registration statement declared effective by the SEC and the existing Canadian short form base shelf prospectus [4] - A preliminary prospectus supplement has been filed with securities commissions in Canada and the SEC in the U.S., with a final supplement to follow [4][5]
Eupraxia Pharmaceuticals Announces Proposed Public Offering of Common Shares
Globenewswire· 2025-09-22 20:01
Core Viewpoint - Eupraxia Pharmaceuticals Inc. has filed a preliminary prospectus supplement for a proposed public offering of common shares, aiming to leverage its proprietary Diffusphere™ technology for drug delivery [1][4]. Group 1: Offering Details - The company plans to grant underwriters a 30-day option to purchase up to an additional 15% of the common shares offered [2]. - The offering will be priced based on market conditions, with final terms to be determined at pricing [2]. - The closing of the offering is subject to customary conditions, including listing approvals from the TSX and Nasdaq [2]. Group 2: Use of Proceeds - Net proceeds from the offering will primarily support the advancement of the product pipeline, including preclinical studies, clinical trials, regulatory submissions, and commercial preparation [4]. - A portion of the proceeds will also be allocated to research and development of additional pipeline candidates, business development initiatives, and general corporate purposes [4]. - The company may use proceeds to expand its intellectual property portfolio and strengthen corporate infrastructure for future growth [4]. Group 3: Company Overview - Eupraxia is a clinical-stage biotechnology company focused on developing locally delivered, extended-release products for high unmet medical needs [7]. - The proprietary Diffusphere™ technology is designed to facilitate targeted drug delivery of both existing and novel drugs [7].
First Set of 1-Year Clinical Results from RESOLVE Trial in Eosinophilic Esophagitis (EoE), Durable and Sustained Symptom & Tissue Responses after Dosing with EP-104GI
Globenewswire· 2025-09-02 12:00
Core Insights - Eupraxia Pharmaceuticals announced positive clinical data from its Phase 1b/2a RESOLVE trial for EP-104GI, a treatment for eosinophilic esophagitis (EoE), showing promising results at 52 weeks post-treatment [1][2]. Clinical Trial Results - The RESOLVE trial demonstrated that patients receiving 4mg of EP-104GI showed clinical remission rates of 56% at Week 12, 78% at Week 24, 67% at Week 36, and 67% at Week 52 [3]. - Two-thirds of patients in the 48mg dose cohort maintained clinical remission after 12 months, indicating durable treatment effects [7]. - Improvements in tissue health were observed across all cohorts, with significant reductions in EoE Histological Scoring System (EoEHSS) scores, showing a 47% improvement in severity and a 44% improvement in extent at Week 36 [8]. Pharmacokinetics - Plasma levels of fluticasone in patients treated with 4mg of EP-104GI remained stable and predictable over 52 weeks, significantly lower than levels typically seen with daily asthma inhalers [9][11]. Market Potential - The treatment regimen for EP-104GI could align with the annual endoscopy routine for EoE patients, contrasting with current treatments that require daily or weekly administration [2]. - EoE affects over 450,000 individuals in the U.S., with increasing incidence and prevalence, highlighting a significant market opportunity for effective treatments [17]. Company Overview - Eupraxia Pharmaceuticals focuses on developing locally delivered, extended-release products targeting high unmet medical needs, utilizing its proprietary Diffusphere™ technology for optimized drug delivery [18][19].
Eupraxia Pharmaceuticals Reports Second Quarter 2025 Financial Results and Provides Business Update
Globenewswire· 2025-08-12 20:25
Core Insights - Eupraxia Pharmaceuticals reported a net loss of $8.7 million for Q2 2025, an increase from a net loss of $6.1 million in Q2 2024, primarily due to rising research and development costs [4] - The company had cash reserves of $19.8 million as of June 30, 2025, down from $33.1 million at the end of Q4 2024, with expectations to fund operations into Q3 2026 [5][6] - The Phase 2b portion of the RESOLVE trial for EP-104GI has commenced, with topline data expected in the second half of 2026 [2][8] Financial Performance - The increase in net loss for Q2 2025 was attributed to higher research and development, general and administrative costs, and other expenses [4] - Cash reserves decreased significantly, indicating a need for careful financial management as the company funds ongoing clinical trials [5] - The company anticipates that existing cash and potential proceeds from in-the-money warrants will sustain operations until at least Q3 2026 [6] Clinical Development - The Phase 2b trial for EP-104GI aims to enroll at least 60 patients across 25 sites globally, focusing on treatment outcomes for eosinophilic esophagitis (EoE) [9] - Recent data from the Phase 1b/2a RESOLVE trial showed sustained positive treatment outcomes in patients after nine months, with no serious adverse events reported [8][9] - The company is optimistic about the potential of EP-104GI to transform the treatment landscape for EoE, with further data updates expected in October 2025 [3][8] Upcoming Events - Eupraxia's management is scheduled to present at several investor conferences, including the Canaccord Growth Conference and the Citi Biopharma Back to School Conference, providing opportunities for investor engagement [12][13]