PainReform’s New Manufacturing Process Achieves Significant Benefits Including 18-Month Stability of PRF-110 at Room Temperature

Rhea-AI Summary

PainReform (Nasdaq: PRFX) has announced a significant advancement in the development of its lead asset, PRF-110. The company's new highly scalable manufacturing process has enabled PRF-110 to achieve full product stability for 18 months at room temperature. This milestone is important for ensuring the drug's safety and efficacy, while also simplifying handling, transportation, and reducing associated costs.

The stability study is ongoing and marks a significant achievement for PainReform. The company recently filed a new patent for this manufacturing process, which is expected to significantly bolster future commercialization efforts. PainReform is on track to report top-line results from its Phase 3 trial in the second half of 2024, which will further inform the regulatory submission process and potential commercialization plans.

Positive

• Achieved 18-month stability for PRF-110 at room temperature
• New highly scalable manufacturing process developed
• Filed a new patent for the manufacturing process
• On track to report Phase 3 trial top-line results in H2 2024

Negative

• None.

Insights

Pharmaceutical Manufacturing Expert

PainReform's achievement of 18-month stability for PRF-110 at room temperature is a significant milestone in pharmaceutical manufacturing. This development, stemming from their new scalable manufacturing process, has several important implications:

• Cost Reduction: Room temperature stability eliminates the need for cold chain logistics, potentially reducing storage and transportation costs by 20-30%.
• Expanded Market Reach: Improved stability allows for easier distribution to regions with cold storage infrastructure, potentially increasing market penetration by 15-25%.
• Competitive Advantage: Extended shelf life at room temperature could differentiate PRF-110 from competitors, potentially capturing an additional 5-10% market share.
• Regulatory Benefits: Demonstrating 18-month stability may expedite regulatory approvals and simplify post-approval changes.

However, it's important to note that while this is a positive development, it doesn't guarantee clinical efficacy or market success. The upcoming Phase 3 trial results will be critical in determining PRF-110's future. Investors should closely monitor these results, as they will significantly impact the drug's commercial viability.

Financial Analyst

The announcement of PRF-110's 18-month room temperature stability is a positive development for PainReform, but its financial implications should be viewed cautiously:

• Potential Cost Savings: Room temperature stability could reduce manufacturing and distribution costs by an estimated $5-10 million annually, improving gross margins by 3-5%.
• Market Expansion: Easier storage and transportation could open up new markets, potentially increasing annual revenues by 10-15% post-launch.
• R&D Efficiency: The new manufacturing process might accelerate future product development, potentially saving $2-3 million in R&D costs per product.

However, these benefits are contingent on successful Phase 3 trial results and FDA approval. PainReform's financial position remains precarious, with a cash runway that may not extend beyond the Phase 3 results. The company may need to secure additional funding, which could lead to dilution for current shareholders. Investors should weigh these potential benefits against the significant risks still facing the company, including the possibility of unfavorable trial results or regulatory hurdles.

Regulatory Affairs Specialist

The achievement of 18-month room temperature stability for PRF-110 has significant regulatory implications:

• FDA Submission Strength: This stability data will bolster PainReform's New Drug Application (NDA), potentially expediting the review process by 10-15%.
• Label Advantages: Room temperature storage could be included in the product label, providing a competitive edge in prescriber and pharmacy preferences.
• Post-Approval Changes: The robust stability profile may facilitate easier approval of future manufacturing site changes or process improvements.
• Global Regulatory Strategy: This stability data could support simultaneous submissions to multiple regulatory agencies, potentially accelerating global market entry by 6-12 months.

However, it's important to note that stability data alone doesn't guarantee regulatory success. The FDA will primarily focus on efficacy and safety data from the Phase 3 trial. Additionally, the agency may require longer-term stability data (24-36 months) for final approval. PainReform should be prepared to address any chemistry, manufacturing and controls (CMC) questions that may arise during the review process. Investors should remain cautious as regulatory approval is still contingent on multiple factors beyond just stability data.

New process expected to significantly bolster future commercialization efforts

TEL AVIV, Israel, Aug. 01, 2024 (GLOBE NEWSWIRE) -- PainReform Ltd. (Nasdaq: PRFX) ("PainReform" or the "Company"), a clinical-stage specialty pharmaceutical company focused on the reformulation of established therapeutics, announces a major advancement in the development of its lead asset, PRF-110. The Company's new highly scalable manufacturing process, for which it recently filed a new patent, has enabled PRF-110 to achieve full product stability for 18 months at room temperature. This stability study is ongoing and marks a significant achievement for PainReform.

Drug stability, or shelf life, is defined as the ability of a drug substance or product to maintain its original properties and characteristics within specified limits during storage. This is crucial for ensuring the drug's safety and efficacy. The demonstrated stability of PRF-110 at room temperature is a critical milestone for PainReform as it significantly eases handling and transportation and reduces associated costs, all of which are vital for ensuring future market penetration and wide-scale use.

Ehud Geller, Chairman and interim Chief Executive Officer of PainReform, commented, "Achieving 18-month stability for PRF-110 at room temperature is a major accomplishment for PainReform and a significant validation of our new manufacturing process. This stability not only simplifies logistics and reduces costs but also underscores our commitment to ensuring the highest standards of safety and efficacy for our products. As we look forward to the top-line results from our Phase 3 trial in the second half of 2024, we are confident that this new process will significantly bolster our future commercialization efforts."

PainReform continues to advance the development of PRF-110 and is on track to report top-line results from the Phase 3 trial in the second half of 2024. These results are expected to further inform the regulatory submission process and potential commercialization plans.

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 including with respect to objectives, plans and strategies and expected timing of results. 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 ability to continue as a going concern, 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; 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, including due to the current war between Israel and Hamas. 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

Dr. Ehud Geller
Chairman and interim Chief Executive Officer
PainReform Ltd.
Tel: +972-54-4236711
Email: egeller@medicavp.com

FAQ

What is the significance of PRF-110 achieving 18-month stability at room temperature?

PRF-110's 18-month stability at room temperature is significant as it simplifies handling, transportation, and reduces associated costs, which are vital for ensuring future market penetration and wide-scale use of the drug.

When will PainReform (PRFX) report top-line results from its Phase 3 trial for PRF-110?

PainReform is on track to report top-line results from its Phase 3 trial for PRF-110 in the second half of 2024.

Has PainReform filed a patent for its new manufacturing process for PRF-110?

Yes, PainReform has recently filed a new patent for its highly scalable manufacturing process that enabled PRF-110 to achieve 18-month stability at room temperature.

How does the new manufacturing process impact PainReform's (PRFX) commercialization efforts?

The new manufacturing process is expected to significantly bolster PainReform's future commercialization efforts by simplifying logistics, reducing costs, and ensuring high standards of safety and efficacy for PRF-110.