Dr. James Helliwell reports

EUPRAXIA PHARMACEUTICALS REPORTS POSITIVE TISSUE HEALTH DATA FROM ITS ONGOING RESOLVE TRIAL IN EOSINOPHILIC ESOPHAGITIS DEMONSTRATING NEAR-COMPLETE IMPROVEMENT ON BIOPSY

Eupraxia Pharmaceuticals Inc. has released positive 12-week and 36-week tissue health data from its continuing phase 1b/2a part of the Resolve trial evaluating EP-104GI for the treatment of eosinophilic esophagitis.

"These tissue health data provide compelling evidence supporting our belief that EP-104GI is addressing the underlying pathology of EoE at the tissue level, as well as managing symptoms," said Dr. James A. Helliwell, chief executive officer of Eupraxia. "While early, the EoEHSS improvements we're seeing are encouraging -- particularly at the highest dose where patients are achieving near-complete normalization of tissue health. What's especially encouraging is the improvement in tissue health is being accompanied by improvements in symptom relief. These improvements are maintained out to 52 weeks after a single administration with no serious adverse events, reinforcing EP-104GI's potential to significantly improve upon the current standard of care as a once-yearly treatment."

Key new findings from the Resolve trial

Tissue health outcomes:

• At 12 weeks after administration, patients who received the highest dose level of EP-104GI (cohort 9, eight milligrams per site, 20 sites, n equals three), demonstrated the greatest improvement from baseline measured to date (EoEHSS grade: minus 0.57 (94-per-cent improvement), stage: minus 0.63 (97-per-cent improvement), representing near-complete normalization of tissue health.
• At 36 weeks after administration, patients in the four-milligram-per-site dose groups (cohorts 5 to 7, 12 to 20 sites, n equals nine) maintained the tissue health improvements seen at week 12 (EoEHSS grade: minus 0.22, stage: minus 0.24).
• A dose-response relationship in EoEHSS grade and stage was observed across the EP-104GI dose cohorts ranging from 2.5 milligrams per site to eight-milligram site.

Clinical remission and symptom response

Due to the open label nature of the study, data from different number of patients can be reported at different time points (two, four, eight, 12, 24, 36 and 52 weeks) following administration of EP-104GI. To date, Eupraxia has observed that in patients who had at least 60 per cent of their esophagus treated with EP-104GI (that is, a minimum of 12 of the 20 potential injection sites injected):

• At 12 weeks (n equals 19), 58 per cent of patients achieved clinical remission;
• At 24 weeks (n equals 14), 79 per cent of patients maintained clinical remission;
• At 52 weeks (n equals six), 67 per cent of patients maintained clinical remission.

Safety and tolerability outcomes:

• To date, over 200 patient-months of follow-up have been reported in 31 patients across all cohorts.
• There have been no serious adverse events reported.
• There have been no cases of oral candidiasis.
• EP-104GI has been reported to be well tolerated at all dose levels, including at the highest dose (eight mg per site).

An updated summary of the above and previously announced clinical trial results are posted in the investor section of the Eupraxia Pharmaceuticals website.

About the Resolve trial

The phase 1b/2a part of the Resolve trial is a multicentre, open-label, dose escalation study evaluating the safety, tolerability, pharmacokinetics and efficacy of EP-104GI in adults with histologically confirmed active EoE. The treatment is administered as a single dose through four to 20 esophageal wall injections, with dose escalations modifying either the dose per site and/or the number of sites. Participants were followed for up to 24 weeks in cohorts 1 to 4 (four times one mg, eight times times one mg, eight times 2.5 mg and 12 times 2.5 mg) or 52 weeks in cohorts 5 to 9 (12 times four mg, 16 times four mg, 20 times four mg, 20 times six mg and 20 times eight mg). Eupraxia plans to disclose additional data from the open-label phase 1b/2a part of the Resolve trial in the coming months.

The phase 2b part of the Resolve trial, a randomized placebo-controlled study of EP-104GI, is currently recruiting with the first clinical dose of 120 mg (20 times six mg). The top-line data from the phase 2b part of the Resolve trial are expected in third quarter 2026.

About Eupraxia Pharmaceuticals Inc.

Eupraxia is a clinical-stage biotechnology company focused on the development of locally delivered, extended-release products that have the potential to address therapeutic areas with high unmet medical need. Diffusphere, a proprietary, polymer-based microsphere technology, is designed to facilitate targeted drug delivery of both existing and novel drugs. The technology is designed to support extended duration of effect and delivery of drugs in a hyperlocalized fashion, targeting only the tissues that physicians are wanting to treat. The company believes the potential for fewer adverse events may be achieved through the precision targeting and the stable and flat delivery of the active ingredient when using the Diffusphere technology, versus the peaks and troughs seen with more traditional drug delivery methods. The precision of Eupraxia's Diffusphere technology platform has the potential to augment and transform existing Food and Drug Administration-approved drugs to improve their safety, tolerability, efficacy and duration of effect. The potential uses in therapeutic areas may go beyond pain and inflammatory gastrointestinal disease, where Eupraxia currently is developing advanced treatments, to also be applicable in oncology, infectious disease and other critical disease areas.

Eupraxia's EP-104GI is currently in a phase 1b/2 trial, the Resolve trial, for the treatment of EoE. EP-104GI is administered as an injection into the esophageal wall, providing local delivery of drug. This is a unique treatment approach for EoE. Eupraxia also completed a phase 2b clinical trial (Springboard) of EP-104IAR for the treatment of pain due to knee osteoarthritis. The trial met its primary end point and three of the four secondary end points. In addition, Eupraxia is developing a pipeline of later- and earlier-stage long-acting formulations. Potential pipeline indications include candidates for other inflammatory joint indications and oncology, each designed to improve on the activity and tolerability of currently approved drugs.

We seek Safe Harbor.