VICTORIA, BC, April 1,
2024 /PRNewswire/ - Eupraxia Pharmaceuticals Inc.
("Eupraxia" or the "Company") (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
(prepared in accordance with U.S. GAAP) and operational highlights
for the fourth quarter ended December 31,
2023. All amounts are expressed in U.S. dollars unless
otherwise indicated.
"The interim results from our ongoing Phase 1b/2a RESOLVE trial, which is evaluating the
safety and efficacy of EP-104GI as a treatment for eosinophilic
esophagitis, demonstrate this product candidate's significant
potential," said Dr. James
Helliwell, CEO of Eupraxia. "In addition, we remain
confident about the results from our recent end-of-Phase 2 meeting
with the U.S. FDA, which clarifies our development path moving
forward for EP-104IAR. The Company is continuing planning and
preparation in support of the Phase 3 osteoarthritis program at
this time. Subsequent to quarter end, we further strengthened our
balance sheet, supporting the ongoing advancement of our product
candidates. Based on the significant data generated for EP-104GI
and EP-104IAR, the Company is continuing to evaluate the potential
to further de-risk development programs through partnering. In
addition, Eupraxia is continuing to pursue a Nasdaq listing for its
common shares."
Change to Reporting Currency and U.S. GAAP
Effective December 31, 2023, the
Company changed its reporting currency to the U.S. dollar ("USD")
from the Canadian dollar ("CAD"). As such, all prior amounts
originally reported in CAD are now reported in USD. The Company has
retained the Canadian dollar as its functional currency.
The Company's consolidated financial statements have also been
prepared in accordance with generally accepted accounting
principles in the United States of
America ("GAAP") as issued by the Financial Accounting
Standards Board ("FASB"). Previously, the Company prepared its
financial statements in accordance with IFRS Accounting Standards
as issued by the International Accounting Standards Board
("IASB").
The changes in reporting currency and adoption of GAAP were made
to enhance the comparability of the Company's results with other
publicly traded companies in the life sciences industry.
Selected Operational and Financial Highlights for the Fourth
Quarter
- Announced positive data from the first cohort of the RESOLVE
Phase 1b/2a clinical trial in
eosinophilic esophagitis ("EoE"), with efficacy signals even at the
initial low dose (4 x 1mg injections), including meaningful symptom
improvement in all patients to at least 12 weeks.
- Disclosed initiation of second cohort for the RESOLVE trial,
with dose escalation approved by the Company's Safety Review
Committee based on data available from the trial's first cohort,
with all second cohort patients subsequently enrolled and
dosed.
- Subsequent to quarter-end, announced additional data from the
ongoing RESOLVE trial, which showed no serious treatment related
adverse events in either the first or second cohort. The second
cohort demonstrated an average 60% and 80% reduction in Dysphasia
and Odynophagia Likert scores, respectively; first cohort patients
had maintained signs of efficacy to six months.
- Submitted the dossier necessary for an end-of-phase 2 meeting
with the U.S. Food and Drug Administration regarding the Phase
2b SPRINGBOARD trial, which is
evaluating EP-104IAR as a treatment of osteoarthritis of the
knee.
- The end-of-phase 2 meeting with the FDA was completed
subsequent to quarter-end and items discussed addressed
non-clinical and clinical topics, including discussions on the size
of the required safety database, and the main design elements of
repeat dose study and the comparative bioavailability study
required to satisfy requirements for a 505(b)(2) approval pathway.
The Company believes a clear understanding of the development path
to approval has been established as a result of the meeting.
- Presented data from the Company's SPRINGBOARD trial at the 2023
Annual Meeting of the American College of Rheumatology.
- Subsequent to quarter-end, on March 15,
2024, closed an overnight marketed offering for gross
proceeds of CAD$33.9 million. The
financing was heavily supported by current shareholders of the
Company.
Fourth Quarter 2023 Financial Review
The Company incurred a net loss of $10.6
million for the three months ended December 31, 2023, versus $7.8 million for the three months ended
December 31, 2022. For the year ended
December 31, 2023, the Company
included a net loss of $29.0 million
versus $19.0 million for the year
ended December 31, 2022. The increase
in net loss was primarily driven by higher costs associated with
the conduct of multiple clinical programs, and increased costs
associated with business development and financing activities.
The Company had cash and cash equivalents of $19.3 million as of December 31, 2023, up from $18.3 million at December
31, 2022. On March 15, 2024,
the Company announced it had closed an overnight marketed public
offering of common shares for gross proceeds, including the
over-allotment, of $25,026,073
(CAD$33,867,784). These funds are
being used to fund clinical trials with EP-104GI and EP-104IAR. The
remainder of the proceeds will be used for general and
administrative expenses, a milestone payment, working capital needs
and other general corporate purposes. Assuming the Company is able
to refinance its existing debt facility with Silicon Valley Bank,
management anticipates cash resources, including proceeds from the
recently closed offering, will be sufficient to fund the Company
through to the third quarter of 2025.
Immediately following completion of the overnight marketed
public offering, the Company had 35,662,553 common shares issued
and outstanding.
Financial Statements and Management Discussion &
Analysis
Please see the audited consolidated financial statements and
related MD&A for more details. The audited consolidated
financial statements for the year ended December 31, 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 will be 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 PK profiles. This
investigational technology can be engineered for use with multiple
active pharmaceutical ingredients and delivery methods.
Eupraxia recently completed a Phase 2b clinical trial (SPRINGBOARD) for its lead
product candidate, EP-104IAR, for the treatment of pain due to OA
of the knee. The trial met its primary endpoint and three of the
four secondary endpoints. Eupraxia has expanded the EP-104 platform
into gastrointestinal disease with the Phase 1b/2a RESOLVE trial for treating EoE. Eupraxia is
also 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", "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 clinical trials,
including the Company's planning and preparation for the Phase 3
osteoarthritis program; the ability of the Company to execute on
its business strategy; the potential of partnerships to de-risk the
Company's development programs; the Company's pursuit of a
Nasdaq listing for its common shares; the Company having sufficient
resources, including anticipated funding from its current cash and
expected refinancing of its existing debt facility with Silicon
Valley Bank; the advancement of opportunities stemming from the
Company's delivery technology and expansion of pipeline designs;
the results gathered from the Company's end-of-phase 2 meeting with
the FDA; 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: 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). 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.