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, 2021. The
Company also announces it has finalized the protocol for its Phase
3 clinical trials of PRF-110 for the treatment of patients
undergoing bunionectomy surgery for submission to the regulatory
authorities.
Ilan Hadar, Chief Executive Officer of
PainReform, commented, "We continue to make progress towards
commencing our Phase 3 clinical trials of PRF-110. Towards this
end, we have been manufacturing clinical trial batches of PRF-110
in preparation for the Phase 3 clinical trials and are working to
address delays due to our CMC partner. We currently expect to
commence our bunionectomy Phase 3 clinical trial toward the end of
the third quarter of this year. We also hired a new head of
clinical operations, which follows the appointment of Lotus
Clinical Research as our clinical research organization to oversee
the two clinical trials in patients undergoing bunionectomy and
hernia repair operations."
Mr. Hadar continued, "Assuming our Phase 3
clinical trials are successful, we believe PRF-110 will address an
important unmet need in the market, especially as an alternative to
systemic opioids, which have contributed to the opioid epidemic.
Moreover, we have maintained a strong balance sheet, with cash and
cash equivalents of $19.4 million as of March 31, 2021, which we
believe should be more than sufficient to support our ongoing
activities beyond completion of our first Phase 3 trial and
reporting top-line data."
"Marjorie D. Tamblyn, our new head of clinical
operations in the U.S., brings over 20 years of experience in
clinical operations leadership in the pharmaceutical/biotech and
Clinical Research Organization industry and will be an important
addition to the team as we advance our clinical trials and begin
preparations for commercial activities. Her skill sets and
leadership skills should be invaluable as we work towards our goal
of establishing PRF-110 as the standard of care in the
post-operative non-opiate pain treatment market. We remain highly
encouraged by our prior data, which demonstrated a strong safety
profile, suggesting a substantial advantage to using PRF-110 over
the local anesthetic, ropivacaine."
Financial Results for the First Quarter
Ended March 31, 2021
Research and development expenses were
$1,029,000 for the three months ended March 31, 2021 compared to
$24,000 for the three months ended March 31, 2020, an increase of
$1,005,000. The increase was primarily due to an increase in
CMC activities and preparation for the initiation of clinical
trials.
General and administrative expenses were
$1,010,000 for the three months ended March 31, 2021 compared to
$108,000 for the three months ended March 31, 2020, an increase of
$902,000 or 835%. The increase was primarily due to costs
related with us becoming a publicly traded company commencing
September 2020, an increase in headcount related costs and an
increase in certain professional services costs.
Financial expense, net was $2,000 for the three
months ended March 31, 2021 compared to financial expenses, net of
$1,164,000 for the three months ended March 31, 2020, a decrease of
$1,162,000. The decrease was primarily due to a decrease in
change in fair value of derivative warrant liability, and interest
expense and amortization of discount on convertible notes.
As a result of the foregoing, the Company
incurred a net loss of $2,041,000 for the three months ended March
31, 2021 compared to a net loss of $1,296,000 for the three months
ended March 31, 2020, an increase of $745,000 or 57%.
As of March 31, 2021, the Company had cash and
cash equivalents of $19,424,000.
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 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.
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
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