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 · GENERAL DEVELOPMENT OF THE BUSINESS
GENERAL DEVELOPMENT OF THE BUSINESS
Three-Year History
2025
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.
2024
On January 30, 2024, the Company announced positive data from a Magnetic Resonance Imaging (“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 (the “Offering”) of Common Shares. 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 million) convertible debt facility (the “Convertible Debt Facility”). Under the Convertible Debt Facility, Yabema Capital Limited and other current Eupraxia shareholders (together, the “Lenders”) made available for drawdown an aggregate amount of $8,659,200 (CDN$12 million) for a period of 120 days following entry into the agreement. The Debt Agreement (as defined below) with Silicon Valley Bank (“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 Officer and Chief 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 “Series 1 Preferred Shares”). The Company issued 8,905,638 Series 1 Preferred Shares for gross proceeds of $31,997,837 (CDN$44,528,190). The material characteristics of the Series 1 Preferred Shares are described herein under the heading “Capital Structure – Series 1 Preferred Shares”.
The holders of Series 1 Preferred Shares are 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 Series 1 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.
2023
On May 18, 2023, the Company announced the appointment of Dr. Mark Kowalski to the role of Chief Medical Officer. This new position reports directly to the Chief Executive Officer (“CEO”) and is responsible for advancing clinical trials and pipeline development.
On June 8, 2023, the Company announced the dosing of the first patient in an open label Phase 1b/2a clinical study (RESOLVE) using EP-104GI in EoE. The RESOLVE study will be conducted in up to 24 adult patients with a confirmed diagnosis and active EoE symptoms. Primary outcomes for safety, pharmacokinetics (“PK”) and efficacy will be collected at various points over a 12-week total period, with a subsequent follow up at six (6) months. Initiallow-dose cohorts presented early signals of efficacy, and we anticipate ongoing safety, efficacy and PK readouts from subsequent dose-escalation cohorts throughout 2024. The RESOLVE protocol is active at sites in Canada, the Netherlands and Australia. Additional sites and jurisdictions will be added as necessary to complete target recruitment.
On June 13, 2023, the Company announced that it had received U.S. Fast Track designation for EP-104IAR in the treatment of OA. This process is designed to facilitate the development and expedite the review of drugs that treat serious conditions and fill an unmet medical need.
On June 22, 2023, the Company filed and obtained a receipt for a final short form base shelf prospectus (the “2023 Shelf Prospectus”). The 2023 Shelf Prospectus replaced the Company’s 2022 Shelf Prospectus filed in January 2022.
On June 26, 2023, the Company announced positive results from its Phase 2b clinical trial of EP-104IAR for pain associated with knee OA. EP-104IAR met its primary endpoint with a clinically meaningful and statistically significant (p=0.004) improvement over vehicle-placebo in WOMAC Pain at 12 weeks.
On August 18, 2023, the Company announced the closing of anon-brokered private placement. The Company issued 3,183,875 Common Shares at a price of CDN$7.00 per Common Share for gross proceeds of CDN$22,287,125.
On September 7, 2023, the Company announced the appointment of KPMG LLP as the auditor of the Company, effective August 30, 2023. Concurrently, Baker Tilly WM, LLP resigned as the Company’s auditor. There were no reportable events involving Baker Tilly WM, LLP.
On October 11, 2023, the Company announced the initiation of a second cohort in its Phase 1b/2a clinical trial in EoE.
On December 12, 2023 the Company announced positive clinical data in its EP-104GI RESOLVE trial.
2022
On January 10, 2022, the Company filed a final short form base shelf prospectus with the securities regulatory authorities in each of the provinces and territories of Canada (the “2022 Shelf Prospectus”). The 2022 Shelf Prospectus allowed the Company and certain of its securityholders to qualify the distribution of up to CDN$30 million of common shares, preferred shares, debt securities, warrants, subscription receipts, and units, or any combination thereof during the 25-month period that the 2022 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 April 20, 2022, the Company announced that it had closed an overnight marketed public offering (the “2022 Offering”). Pursuant to the 2022 Offering, Eupraxia issued 7,150,550 units of the Company (the “Units”) at a price of CDN$2.05 per Unit and 181,000 common share purchase warrants of the Company (the “Warrants”) at a price of CDN$0.30 per Warrant for aggregate gross proceeds of approximately CDN$14.7 million. The completion of the 2022 Offering satisfied the requirement to raise CDN$10 million in additional net new capital under the terms of a contingent convertible debt agreement (the “Debt Agreement”) with SVB.
On September 26, 2022, the Company announced the grant of a patent and a notice of allowance for EP-104. The grant of European Patent EP2976062B1 provides compositional and method of use coverage for EP-104 and covers major European markets of commercial significance. The Company believes the new European patent offers strong protection for EP-104 in key European markets until 2034, pending any adjustments or extensions.
On September 26, 2022, the Company also announced the grant of a Brazilian notice of allowance, which will provide compositional andmethod-of-use coverage for EP-104. The Company believes this grant will provide extensive protection for EP-104 in the Brazilian market until 2034, also pending any adjustments or extensions.
On October 11, 2022, the Company provided the following updates to its Phase 2 OA trial:
| • | The study successfully completed all Data Safety Monitoring Board reviews, with no drug-related serious adverse events noted and was observed to be well tolerated. |
| • | The inclusion criteria were expanded to include diagnosed diabetic patients. |
| • | MRIs were added as an elective assessment for remaining patients to be enrolled in the study. |
On October 12, 2022, the Company announced the initiation of the Phase 1b/2a trial of EP-104GI for EoE. Eupraxia has received regulatory and ethics committee clearance to begin the trial in Canada, Australia and the Netherlands, and data from the open label trial is anticipated to start reading out in the first half of 2023.
On November 2, 2022, the Company announced the appointment of Mr. Paul Brennan to the role of Chief Business Officer. This new position reports directly to the CEO and is responsible for advancing partnership opportunities for the Company.
On December 7, 2022, the Company announced that it had completed enrollment, randomization and dosing of the last patient, in its Phase 2 trial that is evaluating the efficacy and safety of EP-104IAR for the treatment of OA of the knee.
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