Dr. James Helliwell reports

EUPRAXIA PHARMACEUTICALS REPORTS 52-WEEK DATA FROM THE HIGHEST DOSE COHORT OF EP-104GI IN ITS ONGOING PHASE 1B/2A RESOLVE TRIAL FOR THE TREATMENT OF EOSINOPHILIC ESOPHAGITIS

Eupraxia Pharmaceuticals Inc. has released updated clinical data from the phase 1b/2a Resolve study highlighting the long duration of response, high remission rates and tolerability of EP-104GI for the treatment of eosinophilic esophagitis (EoE).

"The 52-week and 36-week data from the highest-dosing cohorts of the phase 1b/2a Resolve trial further strengthen the observed durable treatment effects of EP-104GI in EoE patients," said Dr. James Helliwell, chief executive officer of Eupraxia. "In total, we have observed 64 per cent of patients remaining in clinical remission over this 52-week period in addition to clinically meaningful histologic improvements. If achieved, an annual dosing regimen could align well with ACG [American College of Gastroenterology] guidelines supporting routine endoscopic monitoring of EoE patients."

"These encouraging efficacy and durability data suggest that EP-104GI may have the potential to treat patients suffering with EoE with a single annual dose," said Dr. Jeymi Tambiah, chief medical officer of Eupraxia. "We have not observed any treatment-related serious adverse events (SAEs) to date or adverse events related to corticosteroid exposure, such as abnormal changes to glucose levels. Oropharyngeal candidiasis has not been observed in any of the 10 cohorts to date."

Key new findings from the Resolve phase 1b/2a trial

Symptom response and clinical remission as measured by SDI (Straumann Dysphagia Index)

Symptom response is measured in the open-label portion of the Resolve study using the Straumann Dysphagia Index (SDI), a measure of both frequency and intensity of dysphagia on a 10-point scale (ranging from zero to nine). A reduction compared with baseline in the SDI of at least three points is defined as clinical remission.

Newly reported data include the following:

• In Cohort 8b (n equal to four) (20 times six-milligram dose), which was distinguished for Cohort 8 by employing an improved injection technique, the mean reduction in SDI at 36 weeks was 3.3.
• In Cohort 9 (n equal to 3) (20 times eight-milligram dose), the mean reduction in SDI at 36 and 52 weeks was 3.0 at both time points.

In total, the clinical remission rates across cohorts 5 to 9 (the cohorts for patients who are followed up to 52 weeks) are as follows:

• At 12 weeks, 53 per cent (10 out of 19) of patients achieved clinical remission.
• At 24 weeks, 78 per cent (14 out of 18) of patients maintained clinical remission.
• At 36 weeks, 61 per cent (11 out of 18) of patients maintained clinical remission.
• At 52 weeks, 64 per cent (nine out of 14) of patients maintained clinical remission.

Tissue health outcomes as measured by Eosinophilic Esophagitis Histology Scoring System (EoEHSS)

EoEHSS is a standardized scale used to estimate esophageal tissue damage in EoE patients. EoEHSS measures both grade (severity) and stage (extent) of inflammatory and fibrotic features of the disease from biopsies.

In the phase 1b/2a portion of the Resolve trial, EoEHSS data were measured on all cohorts at baseline, Week 4, Week 12 and, for patients in cohorts 5 to 9, at Week 36. Week 36 is the last time point at which histologic measurements are made in the study.

New data were reported for Cohort 8b (20 times six-milligram dose). The mean EoEHSS stage and grade reductions at Week 36 were minus 0.26 (standard deviation equal to 0.13) and minus 0.27 (standard deviation equal to 0.20).

Safety and tolerability reported to date in the phase 1b/2a Resolve study:

• No treatment-emergent or procedure-related SAEs;
• No cases of oropharyngeal candidiasis, a commonly reported adverse event associated with the use of swallowed steroids, have been reported;
• No cases of adrenal insufficiency or glucose derangement;
• EP-104GI has been generally well tolerated at all dose levels, including the highest dose of eight milligrams per site at 20 injection sites (Cohort 9).

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

About the Resolve trial

The phase 1b/2a portion 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 a history of 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. Patients were followed for up to 24 weeks in cohorts 1 to 4 (four times one milligram, eight times one milligram, eight times 2.5 milligrams and 12 times 2.5 milligrams) or 52 weeks in cohorts 5 to 9 (12 times four milligrams, 16 times four milligrams, 20 times four milligrams, 20 times six milligrams and 20 times eight milligrams). Eupraxia plans to disclose additional data from the open-label phase 1b/2a portion of the Resolve trial in the coming months.

The phase 2b portion of the Resolve trial, a randomized placebo-controlled study of EP-104GI, is currently recruiting both the 120-milligram (20 times six milligrams) and 160-milligram (20 times eight milligrams) doses. The interim data from the phase 2b portion of the Resolve trial are expected in December, 2026.

About eosinophilic esophagitis (EoE)

EoE is an inflammatory-mediated disease in which white blood cells migrate into and become trapped in the esophagus, creating pain and difficulty with swallowing food. According to market research from Clearview Healthcare Partners, EoE affects more than 450,000 people in the United States and has been identified by the American Gastroenterological Association as rapidly increasing in both incidence and prevalence. Impacts from both symptoms and interventions frequently lead to mental health issues, compounding the disease burden of EoE for both the health care system and the individual.

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 FDA-approved (U.S. Food and Drug Administration) 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. In addition, Eupraxia is developing a pipeline of later- and earlier-stage, long-acting formulations.

We seek Safe Harbor.