VICTORIA, BC, Nov. 7, 2024
/PRNewswire/ - Eupraxia Pharmaceuticals Inc. ("Eupraxia" or
the "Company") (NASDAQ: EPRX) (TSX: EPRX), a clinical-stage
biotechnology company leveraging its proprietary DiffuSphere™
technology designed to optimize drug delivery for applications with
significant unmet need, today announced its financial results for
the third quarter of 2024. All dollar values are in U.S. dollars
unless stated otherwise.
"During the third quarter, we advanced our Phase 1b/2a RESOLVE trial for EP-104GI as a
treatment for eosinophilic esophagitis, reporting further positive
results from the fourth cohort and presenting the data at prominent
medical conferences internationally," said Dr. James Helliwell, CEO of Eupraxia. "We also
continued to raise the profile of our Phase 2b SPRINGBOARD osteoarthritis trial data through
its publication in leading, peer-reviewed publication The Lancet
Rheumatology. Beyond our important clinical progress,
subsequent to quarter end, we raised C$44.5
million and now anticipate that our EP-104GI program is
funded through Phase 2 development. Finally, we also strengthened
our senior management team and board during the reporting period,
ensuring we have the strongest possible team in place to drive
Eupraxia forward. "
Recent Operational and Financial Highlights
- 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
eosinophilic esophagitis ("EoE").
- Presented RESOLVE clinical trial data at the Controlled Release
Society 2024 Annual Meeting and Expo in Italy in July, and at the 20th International
Symposium on Digestive Endoscopy World Congress for Esophageal
Diseases in Scotland in
September.
- Subsequent to quarter end, on October 2,
2024, the Company announced the appointment of Dr.
Amanda Malone as the Chief Operating
and Scientific Officer of the Company. In addition, the Company
announced the appointment of Dr. Rahul Sarugaser as Executive Vice
President of Corporate Development.
- Subsequent to quarter end, on October
15, 2024, the Company announced that Phase 2b data from its SPRINGBOARD trial evaluating
EP-104IAR for the treatment of knee osteoarthritis was published in
leading peer reviewed medical journal The Lancet
Rheumatology.
- Subsequent to quarter end, on October
31, 2024, the Company announced the closing of a
non-brokered private placement of C$44.5
million, the appointment of Mr. Joseph Freedman to its Board of Directors and
the termination of its new C$12
million convertible debt facility.
Third Quarter 2024 Financial Review
The Company incurred a net loss of $6.0
million for the three months ended September 30, 2024, versus $4.9 million for the three months ended
September 30, 2023. The increase in
net loss was primarily driven by a reduction in Other Income
associated with a change in the fair value of financial
instruments.
The Company had cash of $8.7
million as of September 30,
2024, down from $19.3 million at the end of the fourth
quarter of 2023. These funds are being used to fund clinical trials
in EP-104 and the remainder of the proceeds will be used for
general and administrative expenses, working capital needs and
other general corporate purposes.
The Company anticipates that existing cash reserves, combined
with the proceeds from the recently announced non-brokered private
placement of C$44.5 million and
anticipated proceeds from in-the-money warrants, will be sufficient
to fund the Company to the third quarter of 2026.
As of September 30, 2024, the
Company had 35,622,553 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, 2024,
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 EDGAR at
www.sec.gov/search-filings, and 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 designed to deliver targeted,
long-lasting activity with fewer adverse events. DiffuSphere™, a
proprietary, polymer-based micro-sphere technology, is designed to
facilitate targeted drug delivery, with extended duration of
effect, and offers multiple, highly tuneable pharmacokinetic (PK)
profiles. This investigational technology can be engineered for use
with multiple active pharmaceutical ingredients and delivery
methods.
Eupraxia's EP-104GI is currently in a Phase 1b/2a trial, the RESOLVE trial, for the treatment
of EoE. EP-104GI is administered as an injection into the
esophageal wall, providing local delivery of drug. This is a unique
treatment approach for EoE. Eupraxia also recently completed a
Phase 2b clinical trial (SPRINGBOARD)
of EP-104IAR for the treatment of pain due to osteoarthritis of the
knee. The trial met its primary endpoint and three of the four
secondary endpoints. In addition, Eupraxia is developing a pipeline
of later and earlier-stage long-acting formulations. Potential
pipeline indications include candidates for 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 applicable
securities laws. Often, but not always, forward-looking information
can be identified by the use of words such as "plans", "is
expected", "expects", "suggests", "scheduled", "intends",
"contemplates", "anticipates", "believes", "proposes", "potential"
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 product candidates,
including their expected benefits to patients with respect to
safety, tolerability, efficacy and duration; the results gathered
from studies and trials of Eupraxia's product candidates; the
potential for the Company's technology to impact the drug delivery
process; potential market opportunity for the Company's products;
potential pipeline indications; and expectations regarding the
funding of the Company's operations to the third quarter of 2026,
including the funding of the EP-104GI program through Phase 2
development, and the use of proceeds. 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: risks and
uncertainties related 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 its
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 health pandemics or epidemics 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) and EDGAR (sec.gov). 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.
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SOURCE Eupraxia Pharmaceuticals Inc.