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-99.3 · Regulatory
Regulatory
We participated in apre-IND meeting with the FDA regarding the OA program before submission and subsequent clearance of an IND, allowing evaluation of the product candidate under the SPRINGBOARD Phase 2 OA protocol.
In June 2023, EP-104IAR received Fast Track designation from the FDA. The Fast Track process is designed to facilitate and potentially expedite the development review of drugs to treat serious conditions and fill an unmet medical need. The designation recognizes both the seriousness of knee OA pain and the potential for EP-104IAR to fill the need for extended-release pain relief for this indication.
We believe our planned development pathway for EP-104IAR is supported by several key factors:
| • | following our recent End-of-Phase 2 meeting with the FDA in January 2024, we believe we have alignment on the required endpoints for our Phase 3 clinical trials in order to support an NDA submission; |
| • | an open Investigational New Drug (IND) application with the FDA; |
| • | an abbreviated NDA regulatory pathway under the FDCA, Section 505(b)(2); |
| • | FDA Fast Track designation, recognizing the potential of EP-104IAR to meet an unmet medical need in a serious condition such as OA pain; |
| • | a corticosteroid (FP) with a well-established record of clinical use that supports anti-inflammatory effects, and a well-characterized systemic tolerability profile; |
| • | no evidence of cartilage damage at the therapeutic concentrations intended for humans in the IND-enabling preclinical study; and |
| • | preliminary evidence of rapid and extended pain reduction versus placebo in both Phase 1 and Phase 2 clinical trials. |
***End-of-Phase-2 Meeting with FDA for EP-104IAR ***
In January 2024, we engaged with the FDA in an End-of-Phase-2 meeting to discuss results from the SPRINGBOARD study and to discuss planned clinical andnon-clinical activities to support a New Drug Application (“NDA”) for EP-104IAR. Based on these interactions, we believe that the following clinical trials will be required in support of a future NDA submission for EP-104IAR:
| • | PROMENADE – A Phase 3 trial in of knee OA patients to evaluate the safety and efficacy of single and repeat doses of EP-104IAR. We anticipate that patients will be followed for a maximum of nine months after the second injection. |
| • | A Phase 1 study carried out in approximately 30 patients comparing the pharmacokinetics of EP-104IAR and Flovent® HFA (required to satisfy PK requirements for a US 505(b)(2) application). |
In addition to the anticipated clinical trials described above, we anticipate that we or a potential partner would need to conduct additionalnon-clinical work to support repeat dosing of EP-104IAR and the characterization of PVAin-line with the FDA’s feedback.
We anticipate that we or a potential partner would submit the NDA for EP-104IAR under Section 505(b)(2) of the FDCA to obtain FDA approval, which is required before marketing a new drug in the United States. A 505(b)(2) NDA would rely in part onnon-clinical studies and clinical trials conducted by us or a potential partner, and in part on the FDA’s prior findings of safety and efficacy for the active ingredient for which we do not have a right of reference or which have been established in the scientific literature in the public domain. We intend to, either alone or with a partner, pursue marketing approval and commercialization of EP-104 in the U.S. and additionalex-U.S. geographies along with the potential partner.Lifecycle Opportunities for EP-104 Products
Corticosteroids are broadly used for various indications that may benefit from a targeted delivery and extended-release profile with minimal adverse events. Natural lifecycle extensions for EP-104 products could include other joints affected by OA, other inflammatory arthropathies, or other inflammatory conditions.
Eupraxia Business Strategy
Our focus over the 24 months following the date of this MD&A will be the execution of the EP-104 development programs, including:
EP-104GI Program:
| • | Continued dose escalation and completed enrollment of the Phase 1bRESOLVE 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 MD&A.
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.
Significant Company Events
On January 30, 2024, the Company announced positive data from a MRI exploratorysub-study in its Phase 2 SPRINGBOARD trial evaluating the safety and efficacy of EP-104IAR for the treatment of osteoarthritis of the knee.
On February 1, 2024, the Company announced summary results from the End-of-Phase 2 meeting with the FDA and the initiation of the Phase 3 Development program for EP-104IAR.
On February 5, 2024, the Company announced updated positive clinical trial data in its EP-104GI RESOLVE trial for the treatment of Eosinophilic Esophagitis.
On February 5, 2024, the Company filed and obtained a receipt for a final short form base shelf prospectus (the “Shelf Prospectus”). The Shelf Prospectus replaced the Company’s 2023 Shelf Prospectus filed in June 2023. The Shelf Prospectus allows the Company and certain of its securityholders to qualify the distribution of up to US$200 million of Common Shares, preferred shares, debt securities, warrants, subscription receipts, and units, or any combination thereof during the 25-month period that the Shelf Prospectus is effective, in amounts, at prices and on terms based on market conditions at the time of any offering, and set forth in an accompanying shelf prospectus supplement.
On March 15, 2024, the Company announced the closing of an overnight marketed offering of Common Shares (the “Offering”). The Company issued 8,260,435 Common Shares at a price of CDN$4.10 per Common Share for gross proceeds of $25,026,073 (CDN$33,867,784), which included the issuance of 943,435 Common Shares upon partial exercise of the over-allotment option.
On April 3, 2024, the Company announced that it had received approval from the Nasdaq Capital Market (“Nasdaq”) to list its Common Shares on the stock exchange. On April 5, 2024, the Company subsequently announced that its Common Shares had begun trading on the Nasdaq under the ticker “EPRX.” Common Shares continue to be traded on the Toronto Stock Exchange under the ticker symbol “EPRX.”
On May 2, 2024, the Company announced the formation of a Clinical Advisory Board for its gastrointestinal program. The Clinical Advisory Board is comprised of Dr. Evan Dellon (Chairman), Dr. Stephen Attwood, Dr. Albert Bredenoord, Dr. Donna Griebel, Dr. Ikuo Hirano and Dr. Roos Pouw. The Clinical Advisory Board will work closely with Eupraxia as it continues its development of EP-104GI for EoE.
On May 21, 2024, the Company announced additional positive clinical data from its Phase 1b/2a RESOLVE trial, which is evaluating the safety and efficacy of EP-104GI as a treatment for EoE.
On May 23, 2024, the Company announced that regulators in Australia and Canada have cleared the Company’s request to expand its Phase 1b/2a RESOLVE trial, which is evaluating the safety and efficacy of EP-104GI as a treatment for EoE. Clinical data from initiallow-dose cohorts showed signs of potential efficacy, as well as encouraging safety and duration of impact from EP-104GI.
On August 2, 2024, the Company announced a new $8,659,200 (CDN$12,000,000) convertible debt facility (the “Convertible Debt Facility”). Under the Convertible Debt Facility, Yabema Capital Limited and other current Eupraxia shareholders (together, the “Lenders”) will make available for drawdown an aggregate amount of $8,659,200 (CDN$12,000,000) for a period of 120 days following entry into the agreement. The Convertible Debt Facility will mature 24 months from August 1, 2024 (the closing date) and can be extended for an additional 12 months at the Lenders’ option. The decision to draw on the facility within 120 days of closing is at the discretion of Eupraxia. The aggregate unpaid principal amount and any accrued and unpaid interest thereon will be convertible at the discretion of the lenders into Eupraxia Common Shares at a conversion price equal to CDN$4.84375 per Common Share. An existing debt agreement with SVB and SVB Innovation Credit Fund VIII, L.P. was subsequently repaid September 12, 2024.
On September 11, 2024, the Company announced additional positive clinical data from its RESOLVE Phase 1b/2a trial which is evaluating the safety and efficacy of EP-104GI as a treatment for EoE.
On October 2, 2024, the Company announced the expansion of Dr. Amanda Malone’s role to that of Chief Operating and Scientific Officer of the Company.
On October 15, 2024, the Company announced that Phase 2b data from the SPRINGBOARD trial evaluating EP-104IAR for the treatment of knee osteoarthritis was published inLancet Rheumatology.
On October 31, 2024, the Company announced the closing of anon-brokered private placement (the “Private Placement”) of newly issued Series 1 Preferred shares in the capital of the Company (the “Preferred Shares”). The Company issued 8,905,638 Preferred Shares for gross proceeds of $31,997,837 (CDN$44,528,190). The Preferred Shares are convertible into Common Shares without additional consideration on aone-to-one basis, subject to customary anti-dilution protection for share splits, reorganizations and other customary conditions.
The Preferred Shares are not initially entitled to any dividends. Following the third anniversary of closing of the Private Placement, and subject to shareholder approval, any unconverted Preferred Shares will be entitled to a quarterly dividend equal to 1.5% (6% annually) of the original issue price, payable in additional Preferred Shares (the “PIK Preferred Shares”). If shareholder approval for the PIK Preferred Shares is not obtained by the third anniversary of closing, the quarterly dividends will be paid in cash at a rate of 2% (8% annually). No dividends will be payable on Common Shares while any Preferred Shares remain issued and outstanding.
The holders of Preferred Shares will be entitled to nominate one representative to the board of directors of the Company. Concurrently with the closing of the Private Placement, Joseph Freedman was appointed to the board of directors of the Company as the first nominee of the holders of Preferred Shares.
Concurrent with the closing of the Private Placement, on October 31, 2024, the Company entered into a Termination and Release Agreement with the Lenders to terminate the Convertible Debt Facility (the “Termination Agreement”), in connection with the closing of the Private Placement.
On November 12, 2024, the Company announced positive data from the fifth cohort of its RESOLVE Phase 1b/2a trial which is evaluating the safety and efficacy of EP-104GI as a treatment for EoE.
On November 20, 2024, the Company announced a single administration of DiffuSphere™ successfully delivered fluticasone propionate for at least six months in patients with eosinophilic esophagitis.
On February 18, 2025, the Company announced the appointment of Alex Rothwell as the Company’s new Chief Financial Officer, coinciding with the retirement of Bruce Cousins. Bruce will remain with the Company in a consultant role to ensure an orderly transition of the CFO responsibilities.
On February 25, 2025, the Company announced positive data from the sixth cohort of its RESOLVE Phase 1b/2a trial which is evaluating the safety and efficacy of EP-104GI as a treatment for EoE.
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