VICTORIA, BC, March 23,
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 audited financial
results (prepared in accordance with International Financial
Reporting Standards or "IFRS") and operational highlights for the
fourth quarter and year ended December 31,
2022. All amounts are expressed in Canadian dollars unless
otherwise indicated.
"The fourth quarter of 2022 was a period of accelerated progress
for Eupraxia," said Dr. James
Helliwell, CEO of Eupraxia. "We advanced our innovative drug
delivery technology platform during the reporting period with the
commencement of a Phase 1b/2a trial
of EP-104GI in eosinophilic esophagitis. This open-label study is
on track to generate interim data readouts in the second quarter of
2023, with complete top-line data anticipated in the second half of
2023. We also continued to make strong progress with our Phase 2
trial of EP-104AR in osteoarthritis, with top-line data readout
expected in the second quarter of this year. In parallel with our
ongoing pipeline progress, we recently announced the appointment of
Paul Brennan as Chief Business
Officer as we look to fully resource and fund each of our
high-potential clinical programs."
Going forward, the Company intends to use "EP-104IAR" when
referring to the product intended for intraarticular injections for
indications such as osteoarthritis, "EP-104GI" when referring to
the product intended for submucosal injections in the GI tract for
indications such as eosinophilic esophagitis, and simply "EP-104"
when referring to disclosure related to both EP-104IAR and
EP-104GI.
Selected Operational and Financial Highlights for the Fourth
Quarter
- Concluded the quarter ended December 31,
2022, with cash and cash equivalents of $24.7 million. Eupraxia anticipates its current
cash is sufficient to fund the Company through to the fourth
quarter of 2023.
- Announced the appointment of Paul
Brennan, a seasoned business development executive with more
than three decades in the healthcare space, to the role of Chief
Business Officer. Mr. Brennan is working closely with the executive
management team to secure partnership opportunities to help advance
the Company's pipeline of drug candidates.
- Announced the completion of Data Safety Monitoring Board
reviews for the Phase 2 osteoarthritis ("OA") trial, the inclusion
of patients with diabetes into the trial, and the inclusion of
Magnetic Resonance Imaging in the trial's protocol.
- Completed enrollment in the Phase 2 OA trial.
- Announced the initiation of a Phase 2 trial of EP-104GI in
adult patients afflicted with eosinophilic esophagitis, a rare
disease that restricts the ability to swallow food and greatly
impacts quality of life.
- Recent developments with Silicon Valley Bank ("SVB") have not
impacted the Company's outlook for cash runway. The Company holds
no amounts on deposit with SVB and its convertible debt facility
with SVB that matures in June 2024
remains in good standing, is fully drawn and is not callable by
SVB.
Fourth Quarter and Full Year 2022 Financial Review
The Company continued to enroll and dose patients in its
300-patient Phase 2 clinical trial of EP-104IAR for OA,
completing enrollment just prior to year end. Operating
expenses for the three months ended December
31, 2022, were $8.8 million,
versus $3.4 million in the prior-year
period. For the full-year period, operating expenses grew to
$23.2 million, versus $18.7 million during the comparative period in
2021. The increase for both periods was primarily driven by
increased costs associated with its Phase 2 OA clinical trial.
The Company incurred a net loss of $9.1
million for the three months ended December 31, 2022, versus $3.8 million for the three months ended
December 31, 2021. For the year ended
December 31, 2022, the Company
incurred a net loss of $23.9 million
compared to a net loss of $23.4
million for the year ended December
31, 2021. The increase in net loss was primarily
driven by increased costs associated with its Phase 2 OA clinical
trial.
The Company had cash and cash equivalents of $24.7 million as of December 31, 2022. Management believes its
current cash is sufficient to fund the Company through to the
fourth quarter of 2023.
As of December 31, 2022, the
Company had 21,593,145 common shares issued and outstanding.
Financial Statements and Management Discussion &
Analysis
Please see the audited consolidated financial statements and
related Management's Discussion & Analysis ("MD&A") for
more details. The audited consolidated financial statements for the
year ended December 31, 2022, 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 www.sedar.com 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 alternatives
to currently approved drugs. Each of Eupraxia's product candidates
has the potential to address therapeutic areas with high unmet
medical need and strives to provide improved patient benefit by
delivering targeted, long-lasting activity with fewer side
effects.
Eupraxia's lead product candidate, EP-104IAR, is currently in
Phase 2 development for the treatment of pain due to osteoarthritis
of the knee. The EP-104 platform has expanded into gastrointestinal
disease with the launch of 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 advancement of
opportunities stemming from the Company's delivery technology and
expansion of pipeline designs; the resourcing and funding of
programs; the expectations regarding Mr. Brennan and his role as
Chief Business Officer; the securing of potential partnership
opportunities; expected availability of data; 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 and effectiveness; 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 (www.sedar.com). 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.