Eupraxia Pharmaceuticals Reports Second Quarter 2023 Financial Results

VICTORIA, BC, Aug. 11, 2023 /CNW/ - Eupraxia Pharmaceuticals Inc. ("Eupraxia" or the "Company") (TSX: EPRX), a Phase 2 clinical-stage biotechnology company with an innovative drug delivery technology platform, today announced its financial results (prepared in accordance with International Financial Reporting Standards) and operational highlights for the second quarter ended June 30, 2023. All amounts are expressed in Canadian dollars unless otherwise indicated.

"During our second quarter, we announced exceptional results from our Phase 2b clinical trial of EP-104IAR for pain associated with knee osteoarthritis," said Dr. James Helliwell, CEO of Eupraxia. "The EP-104IAR Phase 2b study is the largest study in the Company's history and we believe that the data is an important indicator on the drug candidate and our underlying diffusion technology. On the strength of the trial's data, we are working on the optimal path forward for EP-104IAR with key opinion leaders and preparing for an End of Phase 2 meeting with the FDA. Concurrently, we have made significant progress with our ongoing Phase 1b/2a trial of EP-104GI in eosinophilic esophagitis ("EoE"), which is actively recruiting patients. Based on progress to date, this open-label study remains on track for interim data beginning to read out in the third quarter of 2023."

Selected Operational and Financial Highlights for the Second Quarter

• On June 26, 2023, Eupraxia announced positive results from its Phase 2b clinical trial of EP-104IAR for pain associated with knee osteoarthritis. 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 May 18, 2023, the Company announced the appointment of Dr. Mark Kowalski to the role of Chief Medical Officer. Dr. Kowalski brings considerable experience in drug development to the Company and is responsible for advancing clinical trials and pipeline development.
• On June 8, 2023, Eupraxia announced the dosing of the first patient in the Phase 1b/2a trial of EP-104GI in adult patients afflicted with EoE, a rare disease that restricts the ability to swallow food and greatly impacts quality of life. The study now has five active sites in three countries and interim data readouts are expected to begin in the third quarter of 2023.
• On June 13, 2023, the Company announced that it had received U.S. Fast Track designation for EP-104IAR in the treatment of osteoarthritis. This process is designed to facilitate the development and expedite the review of drugs that treat serious conditions and fill an unmet medical need.
• Concluded the quarter ended June 30, 2023, with cash and cash equivalents of $19.1 million.

Second Quarter 2023 Financial Review

The Company continued to conduct its Phase 1b/2a in adult patients afflicted with EoE, prepare for top-line data readout in its 300-patient Phase 2 clinical trial of EP-104IAR for osteoarthritis in the quarter, and reported top-line data from the clinical trial of EP-104IAR in late June 2023.

The Company incurred a net loss of $8.0 million for the three months ended June 30, 2023, versus $6.3 million for the three months ended June 30, 2022. The increase in net loss was primarily driven by higher costs associated with the conduct of clinical trials.

The Company had cash and cash equivalents of $19.1 million as of June 30, 2023, up from $18.9 million at the end of the first quarter of 2023. Management believes its current cash is sufficient to fund the Company to the fourth quarter of 2023.

Subsequent to quarter end, the Company announced a non-brokered private placement of up to 3,142,857 common shares of the Company (each, a "Share"), at a price of C$7.00 per Share, for gross proceeds of up to C$22,000,000 (the "Private Placement"). The Private Placement is now expected to close on or about August 16, 2023 and is subject to certain conditions including, but not limited to, the receipt of all necessary approvals, including the approval of the Toronto Stock Exchange.  Subject to being fully subscribed upon close, the Private Placement would extend cash runway to the second quarter of 2024.

As of June 30, 2023, the Company had 23,795,229 common shares issued and outstanding.

Financial Statements and Management Discussion & Analysis

Please see the unaudited interim condensed consolidated financial statements and related Management's Discussion & Analysis ("MD&A") for more details. The unaudited interim condensed consolidated financial statements for the quarter ended June 30, 2023, and related MD&A have been reviewed and approved by Eupraxia's Audit Committee and Board of Directors. For a more detailed explanation and analysis, please refer to the MD&A that has been filed under the Company's profile on SEDAR+ at sedarplus.ca and is also available on the Company's website at www.eupraxiapharma.com.

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. The Company strives to provide improved patient benefit and has developed a 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 dosed patients in a Phase 1b/2a program to treat eosinophilic esophagitis. 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.

Notice Regarding Forward-looking Statements and Information

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 Company's Phase 2 clinical trials; the ability of the Company to execute on its business strategy; the Company having sufficient resources, including anticipated funding from its current cash; the Private Placement, including the closing date thereof, the satisfaction of the conditions of closing including receipt of required approvals, and the projected extension of cash runway; the advancement of opportunities stemming from the Company's delivery technology and expansion of pipeline designs; the expectations regarding Mr. Kowalski and his role as Chief Medical Officer; the expected benefits of the Company's recently granted U.S. Fast Track designation; the expected trial timelines for interim and top-line data readout; the potential of Eupraxia's product candidates; 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; the potential for the Company's technology to impact the drug delivery process; the competitive advantages of the Company's technology; 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; 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 our 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; 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.