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 second
quarter ended June 30, 2023.
Ilan Hadar, Chief Executive Officer of
PainReform, stated, “We are pleased to report continued progress
advancing PRF-110, our lead drug candidate for post-operative
extended pain relief, thereby reducing the potential need for the
use of opiates. Most notably, we announced positive pharmacokinetic
(PK) data in the first part of our two-part Phase 3 clinical trial
of PRF-110 in bunionectomy. We are encouraged by this data, which
exceeded the FDA safety requirements.”
“Since we encountered issues in manufacturing
due to circumstances outside our control, it resulted in a delay in
the commencement of the second part of the Phase 3 trial. We have
worked closely with our API (active pharmaceutical ingredient)
supplier to resolve their deficiency notice. As a result, we are
hopeful that the second part of our Phase 3 trial will commence in
the fourth quarter of 2023. 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.”
“We remain confident of the safety and quality
of our product as an alternative to systemic opioids.
Moreover, we remain highly encouraged by the outlook for the
program given the positive PK data in the first part of our Phase 3
trial, as well the favorable results of our prior Phase 2 data in
hernia repair. For these reasons, we believe PRF-110 holds
enormous potential in the multi-billion postoperative pain market
with the potential to become standard of care.”
Financial Results for Six Months Ended
June 30, 2023
Research and development expenses were $2.7
million for the six months ended June 30, 2023, compared to $1.4
million for the six months ended June 30, 2022, an increase of $1.3
million. The increase was primarily due to an increase in clinical
trials costs and manufacturing costs.
General and administrative expenses were $2.0
million for the six months ended June 30, 2023, compared to $2.1
million for the six months ended June 30, 2022. An increase in
headcount related expenses was offset by a decrease in insurance
costs and certain professional services costs.
Financial income, net was $179,000 for the six
months ended June 30, 2023, compared to negligible financial income
for the six months ended June 30, 2022. The increase was primarily
due interest from deposits.
Net loss for the six months ended June 30, 2023
was $4.5 million, compared to a net loss of $3.5 million for the
six months ended June 30, 2021, an increase of $1.0 million. The
increase was primarily due to an increase in payments for clinical
trials costs and manufacturing costs.
As of June 30, 2023, the Company had cash, cash
equivalents and short-term deposits of $6.2 million.
Subsequent to June 30, 2023, the Company completed two registered
direct offerings and private placements for gross proceeds of $4.2
million, which is expected to significantly extend the Company’s
cash runway.
About PainReform
PainReform is a clinical-stage specialty
pharmaceutical company focused on the reformulation of established
therapeutics. PRF-110, the Company's lead product is based on the
local anesthetic ropivacaine, targeting the postoperative 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 postoperative 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
Statements
This 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
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