VICTORIA, BC, Nov. 14,
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 third quarter ended
September 30, 2023. All amounts are
expressed in Canadian dollars unless otherwise indicated.
"We made substantial progress during the quarter in the
development of our lead product candidates EP-104IAR for pain
associated with knee osteoarthritis, and EP-104GI in eosinophilic
esophagitis," said Dr. James
Helliwell, CEO of Eupraxia. "These advancements supported
our successful financing, which closed during the quarter, and
provide a base for the Company to continue building out its
innovative drug delivery technology platform, which underpins
EP-104IAR and EP-104GI."
Restatement of Financial Statements and Management's
Discussion and Analysis ("MD&A")
As a result of certain accounting analysis and valuation
positions taken with respect to previous periods, and after
consultation with Eupraxia's newly appointed auditor KPMG LLP, the
Company is restating its audited condensed consolidated financial
statements and related MD&A for the years ended December 31, 2022, and 2021. The restatements
caused an increase in net loss for 2022 to be restated as
$25.0 million (previously
$23.9 million), and an increase in
net loss for 2021 to be restated as $24.3
million (previously $23.4
million). The restatements had no effect on the Company's
cash and cash equivalents balance at year end for 2021 and
2022.
Selected Operational and Financial Highlights for the Third
Quarter
- Continued to make substantial progress in the development of
EP-104IAR for pain associated with knee osteoarthritis ("OA") with
preparations ongoing for its upcoming end-of-phase 2 meeting with
the U.S. Food and Drug Administration (the "FDA"), and with
EP-104GI in eosinophilic esophagitis ("EoE"), as recruitment
continues for its Phase 1b/2a
trial.
- On August 18, 2023, closed a
private placement for gross proceeds of $22.3 million.
- On September 8, 2023, presented a
poster and an oral presentation at PAINWeek 2023, a national
conference on pain for healthcare professionals in Las Vegas, NV.
- Concluded the quarter ended September
30, 2023, with cash and cash equivalents of $33.2 million.
- Subsequent to quarter end, on October
11, 2023, announced Cohort 1 safety results and the
initiation, including dose escalation, for the second cohort for
its Phase 1b/2a clinical trial in
EoE.
- Subsequent to quarter end, on October
11, 2023, announced the appointment of KPMG LLP as auditor
of the Company, effective August 30,
2023.
- Subsequent to quarter end, on November
1, 2023, announced late-breaking acceptance of the Company's
abstract for a poster presentation at the 2023 Annual Meeting of
the American College of Rheumatology.
Third Quarter 2023 Financial Review
The Company incurred a net loss of $6.5
million for the three months ended September 30, 2023, versus $5.4 million for the three months ended
September 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 $33.2 million as of September 30, 2023, up from $19.1 million at the end of the second quarter of
2023. Management believes its current cash is sufficient to fund
the Company through to the second quarter of 2024.
As of September 30, 2023, the
Company had 27,263,165 common shares issued and outstanding.
Financial Statements and Management Discussion &
Analysis
Please see the unaudited interim condensed consolidated
financial statements and related MD&A for more details. The
unaudited interim condensed consolidated financial statements for
the quarter ended September 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 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 knee OA. EP-104IAR met its primary
endpoint and three of the four secondary endpoints. The EP-104
platform has expanded into gastrointestinal disease and has
initiated its program to treat EoE. 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 Company's preparations for its
end-of-phase 2 meeting with the FDA, the Company's presentation at
the 2023 Annual Meeting of the American College of Rheumatology,
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; the Company's restatement of
its consolidated financial statements, which may lead to additional
risks and uncertainties, including loss of investor confidence and
negative impacts on the Company's common share price; 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.