PainReform Provides Further Update on Manufacturing of PRF-110

Rhea-AI Summary

PainReform Ltd. (Nasdaq: PRFX) announced a delay in the Phase 3 trial for PRF-110 due to manufacturing issues, which are expected to enhance efficiency and scalability. CEO Ilan Hadar highlighted optimism based on prior Phase 2 results and the potential of PRF-110 in the $12 billion post-operative pain market as a safer alternative to opioids. The company remains committed to providing updates on the trial's start date as they progress.

Positive

• Potential for PRF-110 to become standard-of-care in a $12 billion market.
• Encouraging outlook based on successful Phase 2 clinical study results.

Negative

• Delay in Phase 3 trial commencement due to manufacturing process issues.

TEL AVIV, Israel, Nov. 08, 2022 (GLOBE NEWSWIRE) -- PainReform Ltd. (Nasdaq: PRFX) ("PainReform" or the "Company"), a clinical-stage specialty pharmaceutical company focused on the reformulation of established therapeutics, today provided a further update related to the manufacturing process of clinical batches for PRF-110.

Ilan Hadar, Chief Executive Officer of Pain Reform, stated, “As previously announced, we implemented additional enhancements to our manufacturing process for PRF-110 expected to improve the efficiency and scalability of our manufacturing. We have since encountered issues in the manufacturing process, which will result in a delay in the commencement of our planned Phase 3 trial.   We are moving aggressively on our plans and expect to report further updates as it relates to the expected start of the clinical study as soon as practical. Overall, we remain highly encouraged by the outlook for the business based on the success of our prior Phase 2 proof-of-concept clinical study. Assuming our Phase 3 trial is successful, we believe PRF-110 has the potential to become standard-of-care within the $12 billion post-operative pain treatment market and represents a highly attractive alternative to systemic opioids.”

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

FAQ

What is the delay in the Phase 3 trial for PRF-110 by PainReform (PRFX)?

The Phase 3 trial for PRF-110 is delayed due to manufacturing issues, which are being addressed to improve efficiency.

What market is PRF-110 targeting?

PRF-110 targets the post-operative pain treatment market, valued at $12 billion.

What are the expectations for PRF-110 following the Phase 2 study results?

Based on the successful Phase 2 study, PainReform expects PRF-110 to have significant market potential as an alternative to systemic opioids.

Who is the CEO of PainReform?

Ilan Hadar is the CEO of PainReform.

What is the significance of PRF-110 in PainReform's strategy?

PRF-110 is the lead product candidate aimed at reformulating established therapeutics for enhanced post-operative pain management.