EUPRAXIA PHARMACEUTICALS INC.
For the period ended Dec 31, 2024. Filed Mar 20, 2025.
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The yearly report of certain Canadian companies, filed under a joint US and Canadian system. It is the main yearly account these companies give US investors, largely as filed in Canada.
FY2024 · Filed Mar 20, 2025
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Contents
EX-99.1 · Near-Term Research Activities
Near-Term Research Activities
Our focus over the 24 months following the date of this AIF will be the execution of the EP-104 development programs, including:
EP-104GI Program:
| • | Continued dose escalation and completed enrollment of the Phase 1b RESOLVE clinical study to evaluate the safety and effectiveness of EP-104GI in the treatment of EoE; |
| • | It is our intention to modify the RESOLVE protocol to include a Phase 2 randomized, placebo-controlled component of the trial to further assess the optimal dose(s). |
| • | Initiate and complete non-clinical work to support filing an IND in the US. |
| • | Optimize and manufacture material to support EP-104GI clinical trials, including development of a new vehicle better suited to the location and mode of injection; |
| • | Initiate a Phase 3 program to evaluate the effectiveness and safety of EP-104GI in EoE. |
EP-104IAR Program:
| • | Complete non-clinical studies to support NDA filing that would enhance the EP-104IAR label and evaluate the safety and biocompatibility of all excipients; |
| • | Engage with the FDA to achieve agreement on the commercial manufacturing program; |
| • | Progress the EP-104IAR clinical program into Phase 3, in conjunction with additional funding opportunities (including a potential collaboration partner). |
EP-104 Platform:
| • | Continue to strengthen the IP portfolio around the EP-104 technology; |
| • | Continue to evaluate portfolio options for EP-104 and the DiffuSphere™ technology platform; and |
| • | Continue to develop the manufacturing process to support all programs. |
Where appropriate, we may use strategic collaborations or partnerships to accelerate development and maximize the commercial potential of our development programs. In parallel, we intend to seekout-licencing, co-development or marketing partners for our technology, with the potential to expand and exploit its application fully. It is our intention to put in place conditions and resources, including the potential use of licensing partnerships, that support the success of the development program, marketing authorization(s) and commercialization across multiple jurisdictions, as well as exploitation of any opportunities for lifecycle and patent extension. Depending on market conditions, this may take the form ofco-development or commercialization partnerships, transactional opportunities and/or public financing options.
Pipeline programs are another area of potential growth in the next 24 months. Our technology is potentially compatible with various drugs and therapeutic indications. The pipeline strategy focuses on modulating the release of existing drugs to achieve better clinical outcomes in areas of high medical need. The technology has the potential to be particularly suitable for diseases requiring precisely targeted and controlled localized therapy where broader tissue or systemic exposure should be avoided (e.g., tumour oncology). We have previously investigated indications involving post-surgical pain(EP-105) and post-surgical site infections(EP-201). While both programs demonstrated preclinical evidence of supporting our technology, these programs are currently paused so we can remain focused on the programs described previously in this AIF.
We currently have several pipeline candidates in development with a goal to add a pipeline product candidate over the next 24 months to allow for sustained corporate growth. We expect this to involve a multidisciplinary review of candidate drugs, formulation development,in vitro screening to identify the most promising lead candidates andnon-clinical proof-of-concept studies. The information generated from these inquiries will determine whether we should proceed with further development.
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