Exhibit 99.1
Phar
PainReform Provides Business Update for the Third Quarter of 2022
Implements Technology Improvements Related to PRF-110 Manufacturing Process Ahead of
Planned Phase 3 Clinical Trial in Bunionectomy
Tel Aviv, Israel – November 15, 2022 –
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, 2022.
Ilan Hadar, Chief Executive Officer of Pain Reform, stated, “We are making steady headway towards commencing the Phase 3 U.S. clinical
trial of PRF-110 for post-operative pain relief following bunionectomy surgery. Towards this end, with our CMO in the U.S.A, we implemented a number of enhancements to the manufacturing process. We encountered a requirement for some further work
that delayed the start of the clinical trial. We believe this issue is being rectified and we expect the steps we are taking to ultimately improve the product itself, as well as its manufacturability. We look forward to providing near-term updates
on the manufacturing process and timeline for commencing the Phase 3 trial. Given 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 provide patients with
localized, post-operative pain relief. We believe PRF-110 holds great promise and will ultimately contribute to a reduction in the frequency of opiate use following surgical procedures, thereby lessening the risk of opiate abuse disorder and
ultimately saving lives.”
“We ended the quarter with approximately $12.9 million cash and deposits on hand and no debt, which provides us sufficient runway to
execute on a number of key upcoming milestones. On the heels of the bunionectomy trial, we plan to commence our second Phase 3 trial for pain treatment in hernia repair surgery. Assuming our Phase 3 clinical trials are successful, we believe
PRF-110 will address an important unmet need in the multi-billion dollar post-operative pain treatment market.”
Financial Results for the nine months ended September 30, 2022
Research and development expenses were $2.5 million for the nine months ended September 30, 2022 compared to $2.3 million for the nine
months ended September 30, 2021, an increase of $0.2 million. The increase was primarily due to an increase in chemistry and manufacturing controls (CMC) activities and preparation for the initiation of clinical trials.
General and administrative expenses were $3.1 million for the nine months ended September 30, 2022 compared to $3.2 million for the nine
months ended September 30, 2021, an increase of 0.1 million. The increase was primarily due to an increase in certain professional services costs.
Financial expense, net was $13,000 for the nine months ended September 30, 2022 compared to financial expense, net of $46,000 for the
nine months ended September 30, 20201, a decrease of $33,000. The decrease was primarily due to a decrease in exchange rate differences expenses that was offset with income from bank deposits.
As a result of the foregoing, we incurred a net loss of $5.6 million for the nine months ended September 30, 2022 compared to a net loss
of $5.5 million for the nine months ended September 30, 2021, an increase of $0.1 million.
As of September 30, 2022, the Company had cash and short term deposits of $12.9 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 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 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, LLC
Tel: 212-671-1021
Email: prfx@crescendo-ir.com
Ilan Hadar
Chief Executive Officer
PainReform Ltd.
Tel: +972-54-5331725
Email: ihadar@painreform.com