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.