VICTORIA, BC, Aug. 7, 2024
/PRNewswire/ - Eupraxia Pharmaceuticals Inc. ("Eupraxia" or
the "Company") (NASDAQ: EPRX) (TSX: EPRX), a clinical-stage
biotechnology company leveraging its proprietary DiffuSphere™
technology to optimize drug delivery for applications with
significant unmet need, today announced its financial results for
the second quarter of 2024. All dollar values are in U.S. dollars
unless stated otherwise.
"Our eosinophilic esophagitis ("EoE") clinical program is making
excellent progress, as additional safety and efficacy data from our
ongoing RESOLVE study continues to suggest that EP-104GI could
represent a significant improvement over currently approved
therapies for this debilitating condition," said Dr. James Helliwell, CEO of Eupraxia. "In addition,
during the second quarter, we presented data at two medical
meetings highlighting the potential of our candidate for the
treatment of knee osteoarthritis ("OA"), EP-104IAR, which also
holds the potential to advance the current standard of care in
OA."
Dr. Helliwell continued, "Looking ahead, we anticipate reporting
new data from the fourth cohort of the RESOLVE study in the near
term and we continue to engage prospective partners for possible
licensing of the EP-10IAR program. We look forward to engaging with
the U.S. Food and Drug Administration in the fourth quarter of 2024
on the EP-104GI program and potentially expanding our
gastrointestinal trials into the U.S. With two clinical-stage
assets each having the potential to represent a meaningful
improvement over currently approved therapies, we believe Eupraxia
remains well positioned to create shareholder value."
Recent Operational and Financial Highlights
- On June 14, 2024, the Company
gave an oral presentation at the European Alliance of Associations
for Rheumatology (EULAR) and on April 20,
2024, the Company presented two abstracts at the
Osteoarthritis Research Society International (OARSI) World
Congress 2024. The presentations included results from the
SPRINGBOARD Phase 2b study evaluating
efficacy in patients with knee OA treated with EP-104IAR
(long-acting intra-articular injection of fluticasone propionate).
The study met its primary and three of four secondary endpoints,
suggesting that treatment with EP-104IAR has the potential to
result in clinically and statistically meaningful impact on pain,
while also presenting an encouraging safety profile.
- On May 29, 2024, Eupraxia hosted
a virtual key opinion leader event, featuring Dr. Evan Dellon, MD, MPH, of the University of North Carolina School of Medicine and
Chairman of the Company's Gastrointestinal Clinical Advisory Board.
The event replay and transcript are available on the Company's
website.
- On May 23, 2024, the Company
announced additional data from the Phase 1b/2a RESOLVE study which is evaluating the
safety and efficacy of EP-104GI as a treatment for EoE, which
showed that eight of nine patients responded to treatment, with
early cohorts showing meaningful improvement in patient symptoms
and biological evidence of disease. Based on the positive early
data, the Company applied for a protocol amendment that was cleared
by the Australian Health Authority and Health Canada, seeking to
expand the number of injection sites per patient, increase the
number of participants and extend the follow-up period from 24 to
52 weeks. This significant expansion of the RESOLVE study is based
upon the strength of the data to-date and positions the asset well
toward future registration trials. As of August 7, 2024, the Company has also received
regulatory and ethics approval of the protocol amendment in
the Netherlands.
- On May 18, 2024, Dr. Amanda Malone, the Company's Chief Operating and
Scientific Officer, presented results from the ongoing RESOLVE
study at the Digestive Disease Week (DDW) 2024 Annual Meeting.
- On May 2, 2024, the Company
announced the formation of a Gastrointestinal Clinical Advisory
Board comprised of Dr. Evan Dellon
(Chairman), Dr. Stephen Attwood, Dr.
Albert Bredenoord, Dr. Donna
Griebel, Dr. Ikuo Hirano and
Dr. Roos Pouw. Each of these
physicians represents expertise in the field and will provide
important guidance to the continued development of EP-104GI.
- The Company announced that its common shares would begin
trading on the Nasdaq, under the ticker symbol "EPRX" effective
April 5, 2024. This additional
securities listing provides broader access to capital for the
Company.
- Subsequent to quarter end, on August 2,
2024, the Company announced entry into a new C$12 million convertible debt facility with
Yabema Capital Limited and other current Eupraxia shareholders. The
new convertible debt facility provides an important source of
additional funding from long term, supportive investors, and
creates greater stability to Eupraxia's capitalization structure as
it continues to advance its clinical programs in EoE and OA.
Second Quarter 2024 Financial Review
The Company incurred a net loss of $6.1
million for the three months ended June 30, 2024, versus $9.5
million for the three months ended June 30, 2023. The decrease in net loss was
primarily driven by changes in the fair value of financial
instruments that matured during the period.
The Company had cash of $23.3
million as of June 30, 2024,
up from $19.3 million at the end of
the fourth quarter of 2023. These funds are being used to fund
ongoing 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. As the Company
has recently refinanced its existing debt facility, management
anticipates current cash resources will be sufficient to fund
Eupraxia through to the second quarter of 2025.
As of June 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 June 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/edgar, 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 side effects. 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 knee OA. 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 business strategies and
objectives; the Company's product candidates, including expected
benefits to patients; the results gathered from studies and trials
of Eupraxia's product candidates; the Company's expectations
regarding its product designs, including with respect to patient
benefit, duration, safety, effectiveness and tolerability; future
releases of data; engagement with the U.S. Food and Drug
Administration and timing thereof; the potential for the Company's
technology to impact the drug delivery process; potential pipeline
indications; potential partnering opportunities for the development
of EP-104IAR; and expectations regarding the funding of the
Company's operations and the Company's expectation that current
cash resources will be sufficient to fund the Company through to
the second quarter of 2025. 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 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 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.