PainReform Files Patent Covering Highly Scalable Manufacturing Process for PRF-110 Following Successful Completion and Testing

Rhea-AI Summary

PainReform (Nasdaq: PRFX) has filed a patent for a new, highly scalable manufacturing process for PRF-110, its flagship post-operative pain control product. This development follows successful completion and testing of the process, marking a significant step towards potential market launch. The improved process includes:

• Continuous Process Manufacturing for increased productivity
• Single Reactor Manufacturing for reduced costs and contamination risk
• Enhanced Batch Size capabilities while maintaining quality

These improvements are expected to reduce production costs and COGS for PRF-110. The company has completed its bunionectomy Phase 3 trial and believes PRF-110 could set a new standard in non-opioid post-operative pain relief.

Positive

• Filed patent for new, highly scalable manufacturing process for PRF-110
• Successful completion and testing of the new manufacturing process
• Continuous Process Manufacturing implemented for increased productivity
• Single Reactor Manufacturing introduced to reduce costs and contamination risk
• Enhanced Batch Size capabilities while maintaining product quality
• Expected reduction in production costs and Cost of Goods Sold (COGS)
• Completed bunionectomy Phase 3 trial for PRF-110

Negative

• None.

Insights

Pharmaceutical Manufacturing Expert

The announcement of PainReform's new scalable manufacturing process for PRF-110 is a significant development in the pharmaceutical sector. The shift to continuous process manufacturing and single reactor production represents a substantial improvement in manufacturing efficiency. These changes will likely lead to reduced costs, minimized risk of contamination and greater consistency in product quality. Transitioning to an enhanced batch size while maintaining stringent quality standards could also mean more effective use of resources and potentially quicker time-to-market. These improvements not only enhance the company's competitive edge but also support its goal of providing more affordable and effective pain management solutions.

Market Research Analyst

From a market perspective, PainReform's patent filing for the scalable manufacturing process of PRF-110 is a strategic move. Obtaining patent protection can serve as a substantial barrier to entry for competitors, ensuring that PainReform maintains exclusive rights over their innovative process. This exclusivity can translate to significant market advantages, particularly if PRF-110 becomes a leading product in post-operative pain management. Additionally, the ability to scale production efficiently and cost-effectively positions PainReform to meet market demand more robustly once PRF-110 is commercialized, potentially driving higher profit margins and market share.

Financial Analyst

From a financial viewpoint, the successful development and patenting of a scalable manufacturing process is a positive indicator for PainReform's future profitability. The reduction in production costs and the potential for larger batch sizes suggest that the company can lower its cost of goods sold (COGS), which can significantly improve its gross margins. Moreover, the intellectual property protection can lead to sustained revenue streams without immediate competitive pressures. Investors should be optimistic about these changes, as they signal potential for improved financial performance and a stronger market position upon the commercialization of PRF-110.

TEL AVIV, Israel, July 24, 2024 (GLOBE NEWSWIRE) -- PainReform Ltd. (Nasdaq: PRFX) ("PainReform" or the "Company"), a clinical-stage specialty pharmaceutical company focused on the reformulation of established therapeutics, today announced it has filed a patent covering its new and highly scalable manufacturing process for PRF-110, its flagship product designed to revolutionize post-operative pain control. The patent filing follows successful completion and testing of the new process. This milestone not only marks a critical step forward in preparation for future potential market launch of PRF-110, allowing a smooth step-wise increase of batch manufacturing, but also underscores the Company's commitment to enhancing manufacturing efficiency and reducing costs.

The key improvements introduced in the manufacturing process include:

• Continuous Process Manufacturing: Streamlining production to ensure constant and efficient output, thereby significantly reducing downtime and increasing overall productivity.
• Single Reactor Manufacturing: Simplifying the manufacturing process by using a single reactor, which not only reduces equipment and maintenance costs but also minimizes the risk of exposure to contamination.
• Enhanced Batch Size: Incorporating additional steps that facilitate larger batch sizes while maintaining the stringent product quality attributes.
  

These innovative manufacturing techniques are now being protected by a patent application filed by PainReform, highlighting the Company's dedication to intellectual property support. The introduction of these manufacturing improvements is expected to have a positive impact on the production cost of PRF-110, leading to a reduction in the cost of goods sold (COGS).

"We are immensely proud of our team's achievements in enhancing the manufacturing process for PRF-110," said Ehud Geller, Chairman and interim Chief Executive Officer of PainReform. "These advancements are a testament to our commitment to innovation, quality, and affordability in pain management. As we have completed our bunionectomy Phase 3 trial, we believe that PRF-110 has the potential to set a new standard in post-operative care, offering patients a safer and more effective option for non-opioid pain relief."

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 acting Chief Executive Officer
PainReform Ltd.
Tel: +972-54-4236711
Email: egeller@medicavp.com

FAQ

What patent did PainReform (PRFX) file on July 24, 2024?

PainReform filed a patent covering a new and highly scalable manufacturing process for PRF-110, its flagship product designed for post-operative pain control.

What are the key improvements in PainReform's (PRFX) new manufacturing process for PRF-110?

The key improvements include Continuous Process Manufacturing, Single Reactor Manufacturing, and Enhanced Batch Size capabilities, all aimed at increasing efficiency and reducing costs.

How might the new manufacturing process affect PainReform's (PRFX) production costs?

The new manufacturing process is expected to have a positive impact on production costs, leading to a reduction in the cost of goods sold (COGS) for PRF-110.

What clinical trial phase has PainReform (PRFX) completed for PRF-110?

PainReform has completed the bunionectomy Phase 3 trial for PRF-110.