EPRX Eupraxia Pharmaceuticals Inc

• EP-104IAR and EP-104GI continuing to advance clinically & remain on track
• Corporate initiatives ongoing to position EP-104IAR and EP-104GI for successful outcomes
• Company provides milestones for 2024

VICTORIA, BC, Dec. 11, 2023 /CNW/ - Eupraxia Pharmaceuticals Inc. ("Eupraxia" or the "Company") (TSX: EPRX), a Phase 2 clinical-stage biotechnology company, today announced updates for its two clinical programs, EP-104IAR, its lead drug candidate in development for the treatment of knee osteoarthritis ("OA"), and EP-104GI, a high-potential product candidate in development for the treatment of eosinophilic esophagitis ("EoE").

In addition, the Company provided a progress update on a number of key corporate initiatives.

"Eupraxia continues to make significant progress in the clinical development of EP-104IAR and EP-104GI, building on the strong data reported to date, as we work to finalize the path forward for later-stage clinical testing," said Dr. James Helliwell, CEO of Eupraxia. "Concurrently, we are working through a number of key corporate initiatives, reflecting our growing scale, compelling delivery technology and evolving clinical programs, with the ultimate goal of positioning EP-104IAR and EP-104GI for successful outcomes."

The Company has submitted the required dossier to support an End-of-Phase-2 meeting with the U.S. Food and Drug Administration ("FDA"), which is currently scheduled for late January 2024.

Management believes its recently completed Phase 2 trial, now named the "SPRINGBOARD" trial, was adequate and well controlled and has the potential to become one of the pivotal studies necessary to support approval. At the upcoming FDA meeting, the Company anticipates receiving confirmation of acceptance of its Phase 2 study, as well as the planned path forward for its Phase 3 study.  The Company also anticipates further guidance on the potential for repeat and bi-lateral dosing. Management believes these additional features are important differentiators for the product commercially.

An MRI sub-study continues in selected patients from the Phase 2 trial for EP-104IAR, with additional data on inflammation and cartilage health anticipated in the first quarter of 2024. Management expects this data will potentially provide further evidence of the safety profile of EP-104IAR for patients. This sub-study is small (n=13), and the primary objective is to better inform Eupraxia on the potential use of MRI technology as supportive evidence in the path forward.

The Company is looking forward to releasing data from the first cohort of its ongoing Phase 1b/2a program, now named the "RESOLVE" trial, to treat EoE.

The Company anticipates releasing data by cohort and intends to present safety and efficacy data up to three months from the first cohort in the near term. The Company has previously announced that based on its first external safety review meeting of the RESOLVE trial, the original timeline of the trial was extended to six months to fully characterize the pharmacokinetics (PK) and duration of efficacy that has been demonstrated.

The trial's second cohort has now been fully dosed and further results of the second cohort up to three months are expected in the first half of 2024.

Effective at the end of the 2023 fiscal year, the Company will be transitioning its accounting and financial reporting to U.S. dollars and U.S. GAAP. Management believes this transition will support improved access to capital moving forward and additional flexibility in terms of public share registration.

Eupraxia has now also completed the previously announced transition to a new auditor, KPMG, which is expected to further support its corporate plans.

The Company continues to explore partnering opportunities for all development candidates outside the U.S.

Based on the growing volume of pre-clinical and clinical data reported by the Company, management believes clear proof-of-concept has been established for its underlying delivery technology.

To fully differentiate its technology, and establish a clear commercial position in the marketplace, Eupraxia has formally branded the technology as Diffusphere™.

Diffusphere™, a proprietary, polymer-based micro-sphere technology, facilitates targeted drug delivery, with extended duration of effect, and offers multiple, highly tunable PK profiles.  Diffusphere™ can be used with multiple active pharmaceutical ingredients and delivery methods. The Company intends to fully leverage Diffusphere™ with additional pipeline candidates and explore potential out-licensing opportunities with third-party drug developers.

Looking forward, the Company anticipates it will achieve a number of significant milestones in fiscal 2024. These include:

• End-of-Phase 2 meeting results with the FDA on EP-104IAR
• Interim data from the Company's ongoing imaging sub-study for EP-104IAR
• Additional interim data (by cohort) for EP-104GI from the RESOLVE trial
• Dosing the first patient in a Phase 3 trial for EP-104IAR
• Participating in a Pre-Investigational New Drug meeting with the FDA on EP-104GI
• Nominating additional pipeline candidates

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. The Company strives to provide improved patient benefit and has developed technology that delivers targeted, long-lasting activity with fewer side effects.

Eupraxia's lead product candidate, EP-104IAR, recently completed a Phase 2b clinical trial for the treatment of pain due to osteoarthritis of the knee. EP-104IAR met its primary endpoint and three of the four secondary endpoints. The EP-104 platform has expanded into gastrointestinal disease and has initiated a Phase 1b/2a program to treat EoE. Eupraxia is also developing a pipeline of later- and earlier-stage long-acting formulations. Potential pipeline indications include candidates for both other inflammatory joint indications and oncology, each designed to improve on the activity and tolerability of currently approved drugs. For further details about Eupraxia, please visit the Company's website at: www.eupraxiapharma.com.

This news release includes forward-looking statements and forward–looking information within the meaning of Canadian securities laws. Often, but not always, forward–looking information can be identified by the use of words such as "plans", "is expected", "expects", "scheduled", "intends", "contemplates", "anticipates", "believes", "proposes" or variations (including negative and grammatical variations) of such words and phrases, or state that certain actions, events or results "may", "could", "would", "might" or "will" be taken, occur or be achieved. Forward looking statements in this news release include statements regarding the Company's business strategies and objectives, including current and future plans and opportunities, expectations and intentions; statements regarding the completion of the Company's Phase 2 trial and the path forward for its Phase 3 trial; the ability of the Company to execute on its business strategy, including the anticipated achievement of certain milestones in fiscal 2024; statements regarding the End-of-Phase 2 meeting with the FDA; the potential of Eupraxia's product candidates, including the clinical advancement and projected outcomes of EP-104IAR and EP-104GI; the Company's expectations regarding its product designs, including with respect to patient benefit, duration, safety, effectiveness and tolerability; the results gathered from studies of Eupraxia's product candidates and the timing of release thereof, including with respect to the Company's MRI sub-study and RESOLVE trial; the potential and competitive advantages of Diffusphere™ in connection with the drug delivery process; the advancement of opportunities stemming from Diffusphere™ and the expansion of pipeline designs; the benefits to patients from the Company's drug platforms; the translation of the Company's technologies and expansion of its offerings into clinical applications; statements regarding changes to the Company's accounting and financial reporting; the expected support of KPMG as the Company's new auditor; and the use of the terms "EP-104IAR", "EP-104GI", and "EP-104" in future disclosure.

Such statements and information are based on the current expectations of Eupraxia's management, and are based on assumptions, including but not limited to: future research and development plans for the Company proceeding substantially as currently envisioned; industry growth trends, including with respect to projected and actual industry sales; the Company's ability to obtain positive results from the Company's research and development activities, including clinical trials; and the Company's ability to protect patents and proprietary rights. Although Eupraxia's management believes that the assumptions underlying these statements and information are reasonable, they may prove to be incorrect. The forward–looking events and circumstances discussed in this news release may not occur by certain dates or at all and could differ materially as a result of known and unknown risk factors and uncertainties affecting Eupraxia, including, but not limited to: the Company's limited operating history; the Company's novel technology with uncertain market acceptance; if the Company breaches any of the agreements under which it licenses rights to its product candidates or technology from third parties, the Company could lose license rights that are important to its business; the Company's current license agreement may not provide an adequate remedy for its breach by the licensor; the Company's technology may not be successful for its intended use; the Company's future technology will require regulatory approval, which is costly and the Company may not be able to obtain it; the Company may fail to obtain regulatory approvals or only obtain approvals for limited uses or indications; the Company's clinical trials may fail to demonstrate adequately the safety and efficacy of its product candidates at any stage of clinical development; the Company may be required to suspend or discontinue clinical trials due to side effects or other safety risks; the Company completely relies on third parties to provide supplies and inputs required for its products and services; the Company relies on external contract research organizations to provide clinical and non-clinical research services; the Company may not be able to successfully execute its business strategy; the Company will require additional financing, which may not be available; any therapeutics the Company develops will be subject to extensive, lengthy and uncertain regulatory requirements, which could adversely affect the Company's ability to obtain regulatory approval in a timely manner, or at all; the impact of the COVID-19 pandemic on the Company's operations; the Company's restatement of its consolidated financial statements, which may lead to additional risks and uncertainties, including loss of investor confidence and negative impacts on the Company's common share price; and other risks and uncertainties described in more detail in Eupraxia's public filings on SEDAR+ (sedarplus.ca). Although Eupraxia has attempted to identify important factors that could cause actual actions, events or results to differ materially from those described in forward–looking statements and information, there may be other factors that cause actions, events or results to differ from those anticipated, estimated or intended. No forward–looking statement or information can be guaranteed. Except as required by applicable securities laws, forward–looking statements and information speak only as of the date on which they are made and Eupraxia undertakes no obligation to publicly update or revise any forward–looking statement or information, whether as a result of new information, future events or otherwise.

SOURCE Eupraxia Pharmaceuticals Inc.