Workflow
Diffusphere™
icon
Search documents
Eupraxia Pharmaceuticals Reports Six-Month Symptom Data from the Highest Dose Cohort in its Ongoing Phase 1b/2a RESOLVE Trial in Eosinophilic Esophagitis
Globenewswire· 2026-03-17 11:00
Core Insights - Eupraxia Pharmaceuticals announced positive symptom data from the Phase 1b/2a RESOLVE trial for EP-104GI, targeting eosinophilic esophagitis (EoE) [1][2] Clinical Findings - At 24 weeks, the highest dose cohort (20x8mg) showed a mean reduction of 4.0 points in the Straumann Dysphagia Index (SDI), surpassing the 3.0 points threshold for clinical remission [3][5] - 59% of patients achieved clinical remission at 12 weeks, while 76% maintained remission at 24 weeks, and 67% maintained it at 52 weeks [6] - Cohort 8b demonstrated improved outcomes in histologic and symptom data compared to Cohort 8, indicating enhanced drug delivery [7][12] Safety and Tolerability - The treatment has been well tolerated, with no serious adverse events reported among the 31 patients treated, totaling over 220 patient-months of follow-up [2][5][12] - No cases of oropharyngeal candidiasis or other common adverse events associated with steroid use have been reported [5][12] Study Design and Future Plans - The RESOLVE trial is a multicenter, open-label, dose-escalation study evaluating the safety, tolerability, pharmacokinetics, and efficacy of EP-104GI in adults with active EoE [9] - The Phase 2b portion of the RESOLVE trial is currently recruiting participants, with top-line data expected in Q3 2026 [10] Technology Overview - Eupraxia's proprietary Diffusphere™ technology aims to optimize local drug delivery, potentially improving safety and efficacy in treating conditions with high unmet medical needs [14][15]
Eupraxia Pharmaceuticals Reports Fourth Quarter 2025 Financial Results
Globenewswire· 2026-03-13 01:03
Core Viewpoint - Eupraxia Pharmaceuticals Inc. reported significant clinical milestones and financial results for Q4 2025, indicating a strong position for future growth and development of its lead program, EP-104GI [2][4]. Financial Performance - The company incurred a net loss of $16.7 million in Q4 2025, compared to a net loss of $7.5 million in Q4 2024, primarily due to increased research and development costs for the EP-104GI program and higher general and administrative expenses [4]. - As of December 31, 2025, Eupraxia had cash reserves of $80.5 million, up from $33.1 million at the end of Q4 2024, which is expected to fund operations into the second half of 2028 [5]. Operational Highlights - Eupraxia achieved key clinical milestones in 2025, including positive follow-up data from the RESOLVE trial for eosinophilic esophagitis (EoE) and the completion of a Phase 2b trial for EP-104IAR [9][12]. - The company anticipates multiple clinical readouts from the ongoing RESOLVE trial and plans to initiate additional clinical programs to expand its pipeline [2]. Technology and Product Development - Eupraxia's proprietary Diffusphere™ technology is designed for optimized local drug delivery, targeting therapeutic areas with high unmet medical needs, including pain and inflammatory gastrointestinal diseases [11]. - The company is developing EP-104GI, which is currently in a Phase 1b/2 trial for EoE, and has plans for further long-acting formulations targeting other inflammatory conditions and oncology [12]. Market and Trade Considerations - Management is monitoring the North American trade situation, particularly the impact of proposed tariffs on imported goods, which could affect the company's operations and costs [6][8]. - Eupraxia manufactures its clinical supplies in the U.S. and maintains U.S. dollar balances to mitigate exchange rate fluctuations [7].
Eupraxia Pharmaceuticals Announces Closing of US$63.2 Million Public Offering Including Full Exercise of Underwriter Option
Globenewswire· 2026-02-20 20:10
Core Viewpoint - Eupraxia Pharmaceuticals Inc. successfully closed a public offering of 7,607,145 common shares at a price of US$7.00 per share, raising approximately US$63.2 million in gross proceeds before expenses [1][2]. Group 1: Offering Details - The offering included the full exercise of an option to purchase additional shares and pre-funded warrants to purchase up to 1,428,571 common shares at a price of US$6.99999 per warrant [1]. - The offering was conducted under a U.S. registration statement declared effective by the SEC and a Canadian short form base shelf prospectus [4]. Group 2: Use of Proceeds - The net proceeds from the offering will primarily be used for advancing EP-104GI for eosinophilic esophagitis, including ongoing preclinical studies and Phase 2 clinical trials [3]. - Funds will also support preparations for a Phase 3 clinical trial, regulatory submissions, and manufacturing activities [3]. - A portion of the proceeds will be allocated to expand clinical studies for additional gastrointestinal indications and to enhance the company's research and development efforts [3]. Group 3: Company Background - Eupraxia is a clinical-stage biotechnology company focused on developing locally delivered, extended-release products to address high unmet medical needs [7]. - The company leverages its proprietary Diffusphere™ technology for targeted drug delivery [8].
Eupraxia Pharmaceuticals Announces Pricing of US$55 Million Public Offering of Common Shares and Pre-Funded Warrants
Globenewswire· 2026-02-19 07:18
Core Viewpoint - Eupraxia Pharmaceuticals Inc. has announced a public offering of common shares and pre-funded warrants, aiming to raise approximately US$55 million to advance its clinical programs and expand its pipeline [1][3]. Group 1: Offering Details - The public offering consists of 6,428,574 common shares priced at US$7.00 each and pre-funded warrants to purchase up to 1,428,571 common shares at US$6.99999 each, resulting in gross proceeds of about US$55 million before expenses [1]. - The offering is expected to close on February 20, 2026, pending customary closing conditions, including the listing of shares on the TSX and Nasdaq [1]. - Underwriters have a 30-day option to purchase an additional 1,178,571 common shares under the same terms [1]. Group 2: Use of Proceeds - The net proceeds will primarily fund the advancement of EP-104GI for Eosinophilic Esophagitis, including ongoing preclinical studies and Phase 2 clinical trials, as well as preparations for a Phase 3 trial [3]. - A portion of the funds will be allocated to expand clinical studies for EP-104GI in additional gastrointestinal indications and to support research and development of other pipeline candidates [3]. - The proceeds may also be used for general corporate purposes, including employee salaries, working capital, and expanding the intellectual property portfolio [3]. Group 3: Company Overview - Eupraxia Pharmaceuticals is a clinical-stage biotechnology company focused on developing locally delivered, extended-release products targeting high unmet medical needs [7]. - The company utilizes its proprietary Diffusphere™ technology for optimized local drug delivery [7].
Eupraxia Pharmaceuticals Announces Proposed Public Offering
Globenewswire· 2026-02-18 21:01
Core Viewpoint - Eupraxia Pharmaceuticals Inc. has filed a preliminary prospectus supplement for a proposed public offering of common shares to advance its clinical-stage biotechnology initiatives, particularly focusing on its proprietary Diffusphere™ technology for drug delivery [1][4]. Group 1: Offering Details - The company plans to offer common shares and may grant underwriters a 30-day option to purchase an additional 15% of the shares offered [2]. - The final terms of the offering will be determined at the time of pricing, and the completion of the offering is subject to customary closing conditions, including necessary approvals from the Toronto Stock Exchange and Nasdaq [2]. - Cantor and LifeSci Capital are acting as joint book-running managers, with Bloom Burton as a co-manager for the offering [3]. Group 2: Use of Proceeds - The net proceeds from the offering will primarily support the advancement of EP-104GI for Eosinophilic Esophagitis, including ongoing preclinical studies and Phase 2 clinical trials, as well as preparations for a Phase 3 trial [4]. - Additional funds will be allocated to expand clinical studies for EP-104GI in other gastrointestinal indications and to support research and development of new pipeline candidates [4]. - The company also plans to use a portion of the proceeds for general corporate purposes, including employee salaries, working capital, and expanding its intellectual property portfolio [4]. Group 3: Company Overview - Eupraxia Pharmaceuticals is focused on developing locally delivered, extended-release products aimed at addressing significant unmet medical needs [7]. - The company's proprietary Diffusphere™ technology is designed to facilitate targeted drug delivery of both existing and novel drugs [7].
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].