VICTORIA, BC, Aug. 12,
2022 /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 unaudited
financial results (prepared in accordance with International
Financial Reporting Standards or "IFRS") and operational highlights
for the second quarter ended June 30,
2022. All amounts are expressed in Canadian dollars unless
otherwise indicated.
"Enrollment for our Phase 2 clinical trial, which is evaluating
EP-104IAR's safety and efficacy for the treatment of pain due to
osteoarthritis of the knee, continued as anticipated during the
second quarter, and trial timelines remain on track for data
readout in the first quarter of 2023," said Dr. James Helliwell, CEO of Eupraxia. "In addition,
we significantly strengthened our financial position in the quarter
by completing a financing for gross proceeds of $14.7 million. We believe we are well capitalized
going forward to continue executing our Phase 2 clinical trial,
while focussing on the diversification of our innovative drug
delivery technology platform into other targeted therapeutic
areas."
Selected Operational and Financial
Highlights for the Second Quarter
- As previously disclosed, on April 20,
2022, the Company closed its overnight marketed public
offering for gross proceeds of approximately $14.7 million. By raising this capital, the
Company satisfied the requirement to raise an additional
$10 million in net new capital under
its contingent convertible debt agreement with Silicon Valley Bank
ahead of the June 30, 2022
deadline.
- Advanced the ongoing Phase 2 clinical trial for EP-104IAR,
which is now enrolling patients at sites in Poland and the Czech
Republic, and opened additional sites in Denmark to advance patient screening.
- Concluded the quarter ended June 30,
2022, with cash and short-term investments of $35.5 million. The Company anticipates current
cash runway will fund the business through to the fourth quarter of
2023.
- Subsequent to quarter end, the Company announced that it was
awarded The Emerging Life Sciences Company of the Year Award by
Life Sciences British Columbia. The Emerging Life Sciences Company
of the Year Award is presented to an early-stage life sciences
company which, although not yet achieving commercial success, has
demonstrated outstanding performance, and realized significant
milestones from April 1st,
2021 – March 31st, 2022,
and is positioned well for potential future commercial
success.
Second Quarter 2022 Financial
Review
The Company continued to enroll and dose patients in its
300-patient Phase 2 clinical trial of EP-104IAR. Operating expenses
for the three months ended June 30,
2022, were $6.1 million,
versus $5.0 million in the prior-year
period. The increase for the period was primarily driven by higher
research and development costs associated with the Phase 2 clinical
trial for EP-104IAR and higher general and administrative costs
offset by a decrease in stock-based compensation.
The Company incurred a net loss of $6.3
million for the three months ended June 30, 2022, versus $5.6
million for the quarter ended June
30, 2021. The increase in net loss was driven by higher
research and development costs associated with the Phase 2 clinical
trial for EP-104IAR and higher general and administrative
costs.
The Company had a cash and short-term investments balance of
$35.5 million as at June 30, 2022. Management believes it has
sufficient resources to fund the Company through to the fourth
quarter of 2023.
As of June 30, 2022, the Company
had 21,393,145 common shares issued and outstanding.
Financial Statements and
Management Discussion & Analysis
Please see the unaudited interim condensed consolidated
financial statements and related Management's Discussion &
Analysis ("MD&A") for more details. The unaudited interim
condensed consolidated financial statements for the quarter ended
June 30, 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 EP-104IAR
Eupraxia's lead product candidate, EP-104IAR, is designed to
meet the significant unmet medical need and market demand for
long-lasting pain relief for knee osteoarthritis ("OA"). The U.S.
Centers for Disease Control and Prevention estimates that knee OA
affects more than 30 million people in the U.S. alone. This
includes 14 million that suffer with knee pain or some form of
disability. Knee OA is also associated with depression and loss of
sleep, which can greatly affect quality of life.
With EP-104IAR, Eupraxia hopes to change the way knee OA pain is
treated. Current therapies are challenged by poor safety,
inadequate efficacy and/or limited duration of activity.
Corticosteroids are one of only two drug classes strongly
recommended by the American College of Rheumatology and the
Arthritis Foundation for the treatment of knee OA pain. Currently
approved corticosteroids are very effective at reducing pain for a
short duration late in the disease but can expose the body to
unwanted local and systemic side effects.
EP-104IAR endeavours to provide long-term pain relief with fewer
unwanted side effects. It encapsulates a highly potent
corticosteroid (fluticasone propionate) within a microns-thin
polymer membrane, part of Eupraxia's patented technology
platform.
Injected into the knee, EP-104IAR is intended to diffuse drug
slowly into the knee joint providing therapeutic concentrations for
up to six months. This has the potential dual advantage of
providing long-duration pain relief with fewer systemic side
effects. An enhanced safety profile would also benefit the
estimated 70% of knee OA patients that experience pain in both
knees by allowing simultaneous treatment of both affected
joints.
In contrast to immediate release steroids, a non-clinical study
of EP-104IAR suggests a cartilage sparing effect, which could
provide a safer treatment alternative for those afflicted with
chronic OA pain. The product has also been designed with physician
convenience in mind – targeting a long shelf life, no refrigeration
and easy integration into existing delivery techniques.
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 OA of the
knee. In addition to EP-104IAR, Eupraxia is developing a pipeline
of earlier-stage long-acting formulations. Potential pipeline
candidates include a range of drugs for indications such as
postsurgical pain (EP-105), and post-surgical site infections
(EP-201), each designed to improve on the activity and tolerability
of 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 press 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
trial; the ability of the Company to execute on its business
strategy; the Company having sufficient resources, including
anticipated funding from its current cash runway; the expansion of
enrollment in the Company's Phase 2 clinical trial; expected trial
timelines for data readout; the potential of Eupraxia's product
candidates; the Company's expectations regarding its product
designs, including with respect to targeted shelf life, storage and
ease of integration; 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; the Company's estimation of potential product
markets; and the demand and market acceptance for products
developed by the Company. 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 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.