PainReform Provides Business Update for the Third Quarter of 2023
15 Novembre 2023 - 10:05PM
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 third
quarter ended September 30, 2023.
Ilan Hadar, Chief Executive Officer of
PainReform, stated, "We are pleased to report a number of recent
milestones that have helped advance the clinical development of
PRF-110, our lead drug candidate, targeting the post-operative
extended pain relief market. Following success in the first part of
our Phase 3 clinical trial of PRF-110, we initiated the second,
larger part of the Phase 3 trial in bunionectomy. The first
patients have now been enrolled in the second part of this trial,
with Evolution Research Group (ERG) serving as our contract
research organization (CRO). We look forward to continued
enrollment of this trial, which will include up to 400 patients in
the double-blind study at multiple clinical sites in the U.S.,
measuring pain reduction by PRF-110 over 72 hours compared with
placebo and Naropin® (ropivacaine). Given the positive PK data in
the first part of our Phase 3 trial and the favorable results of
our prior Phase 2 data proof-of-concept clinical study, we are
excited to take the next step on this journey to help address the
nationwide opioid epidemic."
Financial Results for Nine Months Ended September 30,
2023
Research and development expenses were $3.3 million for the nine
months ended September 30, 2023, compared to $2.5 million for the
nine months ended September 30, 2022. The increase was primarily
due to an increase in payments for clinical trial costs and
manufacturing costs that were offset by a decrease in consultant
expenses
General and administrative expenses were $2.7 million for the
nine months ended September 30, 2023, compared to $3.1 million for
the nine months ended September 30, 2022. The decrease was mainly
in insurance costs and certain professional services costs.
Financial income, net, was $1.6 million for the nine months
ended September 30, 2023, compared to financial expense, net, of
$13,000 for the nine months ended September 30, 2022. The increase
in financial income was primarily due to a change in the valuation
of warrants that were issued in July 2023 and recorded as a
liability, and receipt of interest from deposits.
Net loss for the nine months ended September 30, 2023, was $4.5
million, compared to a net loss of $5.6 million for the nine months
ended September 30, 2022.
As of September 30, 2023, the Company had cash and short-term
deposits of $8.6 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 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; 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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