Mr. James Meikle reports

EUPRAXIA PHARMACEUTICALS REPORTS SYMPTOM RESPONSE DATA FROM ITS ONGOING PHASE 1B/2A RESOLVE TRIAL, INCLUDING NEW DATA ON ODYNOPHAGIA (PAINFUL SWALLOWING) IN EOSINOPHILIC ESOPHAGITIS PATIENTS

Eupraxia Pharmaceuticals Inc. has released positive results from a new analysis of the Resolve study examining the effect of EP-104GI on symptom severity, including for the first time an analysis of the effect of EP-104GI on odynophagia (pain when swallowing). This is important because odynophagia scoring is a component of Dysphagia Symptom Questionnaire (DSQ), a commonly used patient reported outcome used in pivotal clinical trials in EoE patients.

• The number of patients experiencing moderate to severe odynophagia (pain swallowing) in the cohorts analyzed (cohorts 7 to 9) was reduced from 62 per cent at baseline to 25 per cent from 24 through to 52 weeks post-treatment.
• In the same analysis, 23 per cent of patients reported severe odynophagia at baseline; and no patients reported severe odynophagia at the 24 and 52 weeks timepoints.
• The number of patients experiencing moderate to severe dysphagia (difficulty swallowing) in cohorts 7 to 9 was reduced from 77 per cent at baseline to 25 per cent at 24 and 52 weeks post-treatment.
• At baseline 31 per cent of patients in cohorts 7 to 9 had severe dysphagia; no patients had severe dysphagia at 24 and 52 weeks post-treatment.
• EP-104GI continues to be well tolerated by patients receiving the drug. There have been over 130 patients treated in Resolve with EP-104GI or placebo (more than 2,000 individual injection sites) with no reported treatment-emergent or procedure-related serious adverse events (SAEs).

"The results from this analysis of phase 1b/2a data, which looks at the proportion of patients that exhibit different levels of symptom severity following treatment with EP-104GI, support our previously released results and implies that EP-104GI is having a meaningful effect for EoE patients," said Dr. Jeymi Tambiah, chief medical officer of Eupraxia. "In our analysis, we looked at symptom severity in measures of dysphagia and odynophagia at baseline through week 52 of the study. In these measures, we saw meaningful shifts in the proportions of patients towards milder scores for their symptoms. Importantly, this is the first time that we have presented data on odynophagia, which is pain experienced when swallowing food. Odynophagia is experienced by many EoE patients and can have a dramatic effect on a patient's quality of life. In the study there were noted decreases in the number of patients that experienced odynophagia compared to baseline, starting as early as two weeks and lasting out to 52 weeks.

"The results demonstrating that patients treated with EP-104GI experienced an improvement across two distinct measures of symptoms are highly encouraging," continued Dr. Tambiah. "We are also reassured by the low rates and similar profiles of adverse events across both phases of the trial. In the two portions of the phase 1b/2 Resolve trial, there have been over 130 patients treated with EP-104GI or placebo, which equates to more than 2,000 individual injection sites. We have observed no treatment-emergent or procedure-related serious adverse events (SAEs) and have no concerns regarding mean glucose or cortisol levels."

Dr. James Helliwell, chief executive officer of Eupraxia, said: "What is especially encouraging in this finding is that EP-104GI is continuing to demonstrate consistent biological responses. Patients are seeing improvement in their ability to swallow without food becoming stuck, in the pain they experience with swallowing, in endoscopic findings of disease and histologic severity of disease. These improvements seem to be showing durability to 52 weeks. We continue to anticipate our key phase 2b placebo-controlled interim readout in Q4 of this year."

Key results from the analysis of odynophagia following dosing with EP-104GI

Patients in the Resolve trial were asked to grade the degree of odynophagia (pain whilst swallowing) on an 11-point scale (0 equals no pain, 10 equals most severe pain) over the seven previous days. Measurements were recorded at baseline and at weeks two, four, eight, 12, 24, 36 and 52 following dosing with EP-104GI. Symptom severity was graded as most severe (score of 10), severe (scores of 7 to 9), moderate (scores of 4 to 6), mild (scores of 1 to 3) or none (score of 0). An analysis of the distribution of severity of symptom score was performed for the patients that received 20 injections of EP-104GI (cohorts 7 to 9, receiving a total dose ranging from 80 milligrams to 160 mg in 20 injections). The results are presented in the attached figure.

Key highlights from the odynophagia analysis:

• At baseline 62 per cent of the EoE patients reported either moderate or severe odynophagia (n equals 13);
• At two, four, eight and 12 weeks post-treatment, 31 per cent of patients reported moderate or severe odynophagia (n equals 13);
• At 24, 36 and 52 weeks, 25 per cent of patients reported moderate or severe odynophagia (n equals 12, 12 and eight, respectively);
• At baseline, 15 per cent of patients recorded no odynophagia, at 52 weeks, 50 per cent of patients recorded no odynophagia.

Graph shows patient odynophagia category groups changes from baseline to week 52 in the phase 1b/2a portion of the Resolve trial.

Cohorts 7 to 9 received a total dose ranging from 80 mg to 160 mg in 20 injections.

N.B. figure shows distribution of patients by categories per visit, not individual changes.

Key results from the analysis of dysphagia following dosing with EP-104GI.

Patients in the Resolve trial were asked to grade the degree of dysphagia (difficulty swallowing) on an 11-point scale (0 equals no troubles to swallow, 10 equals most severe troubles to swallow) over the seven previous days. Measurements were recorded at baseline and at weeks two, four, eight, 12, 24, 36 and 52 following dosing with EP-104GI. Symptom severity was graded as most severe (score of 10), severe (scores of 7 to 9), moderate (scores of 4 to 6), mild (scores of 1 to 3) or none (score of 0). An analysis of the distribution of severity of symptom score was performed for the patients that received 20 injections of EP-104GI (cohorts 7 to 9, receiving a total dose ranging from 80 mg to 160 mg). The results are presented in the attached figure.

Key highlights from the dysphagia analysis:

• At baseline 77 per cent of the EoE patients reported moderate or severe dysphagia (n equals 13);
• At 12 weeks post-treatment, 54 per cent of patients reported moderate or severe dysphagia (n equals 13);
• At 24 and 52 weeks, only 25 per cent of patients reported moderate or severe dysphagia (n equals 12 and 8, respectively).

Graph shows patient dysphagia category groups changes from baseline to week 52 in the phase 1b/2a portion of the Resolve trial.

Cohorts 7 to 9 received a total dose ranging from 80 mg to 160 mg in 20 injections.

N.B. figure shows distribution of patients by categories per visit, not individual changes.

A summary of the above odynophagia results are included in the Eupraxia corporate presentation available on the Eupraxia Pharmaceuticals website and can be found on-line.

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 a history of confirmed active EoE. The treatment is administered as a single dose via 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 by one mg, eight by one mg, 8 by 2.5 mg and 12 by 2.5 mg) or 52 weeks in cohorts 5 to 9 (12 by four mg, 16 by four mg, 20 by four mg, 20 by six mg and 20 by 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 both the 120 mg (20 by six mg) and 160 mg (20 by eight mg) doses. The interim data from the phase 2b part of the Resolve trial is expected in Q4 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 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. In addition, Eupraxia is developing a pipeline of later and earlier-stage, long-acting formulations.

We seek Safe Harbor.