PainReform Ltd. (Nasdaq: PRFX) ("
PainReform" or
the "
Company"), a clinical-stage specialty
pharmaceutical company focused on the reformulation of established
therapeutics, today provided a business update for the first
quarter ended March 31, 2023.
Ilan Hadar, Chief Executive Officer of
PainReform, stated, “We have made significant progress advancing
the Phase 3 clinical trial to evaluate PRF-110, our lead drug
candidate, for post-surgical pain relief following bunionectomy
surgery. Importantly, we announced the completion of treatment for
the first part of Phase 3 clinical trial of PRF-110, in which 15
patients undergoing bunionectomy surgery were enrolled at two
clinical sites in Texas. We reported positive safety data in the
first part of our Phase 3 clinical trial with no serious adverse
events (SAEs) reported, suggesting a substantial potential
advantage to using PRF-110 over opioids. According to the U.S.
Congress Joint Economic Committee (JEC), the opioid epidemic cost
the United States nearly $1.5 trillion in 2020 and is now the main
driver of drug overdose deaths.”
“We remain on track to complete the analysis of
the initial pharmacokinetic data on the first 15 patients later
this month and then immediately transition to the larger part of
our Phase 3 trial. The upcoming second part of the trial will be a
double-blind study, randomizing approximately 400 patients at seven
clinical sites in the U.S. and measuring pain reduction by PRF-110
over 72 hours compared with placebo and plain ropivacaine.”
“Following the bunionectomy trial, we plan to
commence our second Phase 3 trial for post-surgical pain in hernia
repair. We believe PRF-110 will significantly extend post-operative
analgesia and be significantly safer and less costly to produce
than current alternatives. Given the fact that an estimated 99% of
current surgeries are treated with opiates and that our proprietary
extended-release drug-delivery system has broad potential across a
wide range of surgeries, we believe we are well-positioned to
become standard of care in the $12 billion post-operative pain
relief market.”
Financial Results for the First Quarter
Ended March 31, 2023
Research and development expenses were $1.5
million for the three months ended March 31, 2023, compared to
$680,000 for the three months ended March 31, 2022, an increase of
$0.8 million. The increase in research and development expenses was
primarily due to the expenses leading to the commencement of
our Phase 3 trial.
General and administrative expenses were
$962,000 for the three months ended March 31, 2023 compared to
$992,000 for the three months ended March 31, 2022, a decrease of
$30,000. The decrease in general and administrative expenses is
primarily due to a decrease in directors’ and officers’ liability
insurance premiums costs and expenses.
Financial income (expenses), net was $108,000
for the three months ended March 31, 2023 compared to financial
expenses, net of $22,000 for the three months ended March 31, 2022,
a decrease of $130,000. The decrease was primarily due to an
increase from the Company’s deposits.
As a result of the foregoing, we incurred a net
loss of $2.3 million for the three months ended March 31, 2023
compared to a net loss of $1.7 million for the three months ended
March 31, 2022, an increase of $0.6 million. The increase was
mainly to an increase in expenses associated with our Phase 3
trial.
As of March 31, 2023, the Company had cash and
cash equivalents of $8.1 million.
About PainReform
PainReform is a clinical-stage specialty
pharmaceutical company focused on the reformulation of established
therapeutics. PRF-110, the Company's lead product, currently in
Phase III clinical trial, is based on the local anesthetic
ropivacaine, targeting the post-operative pain relief market.
PRF-110 is an oil-based, viscous, clear solution that is deposited
directly into the surgical wound bed prior to closure to provide
localized and extended post-operative analgesia. The Company's
proprietary extended-release drug-delivery system is designed to
provide an extended period of post-surgical pain relief without the
need for repeated dose administration while reducing the potential
need for the use of opiates. For more information, please visit
www.painreform.com.
Notice Regarding Forward-Looking
StatementsThis press release contains forward-looking
statements about our expectations, beliefs and intentions.
Forward-looking statements can be identified by the use of
forward-looking words such as "believe", "expect", "intend",
"plan", "may", "should", "could", "might", "seek", "target",
"will", "project", "forecast", "continue" or "anticipate" or their
negatives or variations of these words or other comparable words or
by the fact that these statements do not relate strictly to
historical matters. These forward-looking statements are based on
assumptions and assessments made in light of management's
experience and perception of historical trends, current conditions,
expected future developments and other factors believed to be
appropriate. Forward-looking statements in this press release are
made as of the date of this press release, and we undertake no duty
to update or revise any such statements, whether as a result of new
information, future events or otherwise. Forward-looking statements
are not guarantees of future performance and are subject to risks
and uncertainties, many of which are outside of our control. Many
factors could cause our actual activities or results to differ
materially from the activities and results anticipated in
forward-looking statements, including, but not limited to, the
following: our history of significant losses, our need to raise
additional capital and our ability to obtain additional capital on
acceptable terms, or at all; our dependence on the success of our
initial product candidate, PRF-110; the outcomes of preclinical
studies, clinical trials and other research regarding PRF-110 and
future product candidates; the impact of the COVID-19 pandemic on
our operations; our limited experience managing clinical trials;
our ability to retain key personnel and recruit additional
employees; our reliance on third parties for the conduct of
clinical trials, product manufacturing and development; the impact
of competition and new technologies; our ability to comply with
regulatory requirements relating to the development and marketing
of our product candidates; commercial success and market acceptance
of our product candidates; our ability to establish sales and
marketing capabilities or enter into agreements with third parties
and our reliance on third party distributors and resellers; our
ability to establish and maintain strategic partnerships and other
corporate collaborations; the implementation of our business model
and strategic plans for our business and product candidates; the
scope of protection we are able to establish and maintain for
intellectual property rights and our ability to operate our
business without infringing the intellectual property rights of
others; the overall global economic environment; our ability to
develop an active trading market for our ordinary shares and
whether the market price of our ordinary shares is volatile; and
statements as to the impact of the political and security situation
in Israel on our business. More detailed information about the
risks and uncertainties affecting us is contained under the heading
"Risk Factors" included in the Company's most recent Annual Report
on Form 20-F and in other filings that we have made and may make
with the Securities and Exchange Commission in the future.
Contact:Crescendo
Communications, LLCTel: 212-671-1021Email:
prfx@crescendo-ir.com
Ilan HadarChief Executive OfficerPainReform
Ltd.Tel: +972-54-5331725Email: ihadar@painreform.com
PainReform (NASDAQ:PRFX)
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