PainReform Provides Business Update for the First Quarter of 2022

Rhea-AI Summary

PainReform (Nasdaq: PRFX) announced successful batch manufacturing of PRF-110 and progress towards Phase 3 clinical trials expected in H2 2022. CEO Ilan Hadar confirmed that FDA approval for the 505(b)(2) pathway sets the stage for efficient trial execution. The company has $15.4 million in cash and no debt, ensuring capital availability for key milestones. Q1 2022 reported R&D expenses decreased to $680,000, and net loss decreased to $1.694 million, reflecting cost management. PainReform focuses on reformulating established therapeutics for enhanced surgical pain relief.

Positive

• Successful batch manufacturing of PRF-110, aligning with clinical trial timelines.
• Cash reserves of $15.4 million and zero debt indicate strong financial health.
• Decrease in R&D expenses from $1,029,000 to $680,000 showcases cost efficiency.
• Net loss improved from $2,041,000 to $1,694,000, signaling effective financial management.

Negative

• None.

Reports successful batch manufacturing of PRF-110 and continued progress towards commencing Phase 3 clinical trials in the second half of 2022

TEL AVIV, Israel, May 17, 2022 (GLOBE NEWSWIRE) -- PainReform Ltd. (Nasdaq: PRFX) ("PainReform" or the "Company"), a clinical-stage specialty pharmaceutical company focused on the reformulation of established therapeutics, yesterday provided a business update for the first quarter ended March 31, 2022.

Ilan Hadar, Chief Executive Officer of Pain Reform, stated, “We are continuing our steady progress towards commencing the Phase 3 clinical trial of PRF-110 in bunionectomy expected in the second half of 2022. Having been approved for the 505(b)(2) pathway by the FDA, we expect this to be a rapid and cost-efficient trial.   Importantly, the manufacturing tech transfer to our selected CMO, whom we engaged for manufacturing our clinical batches of PRF-110, is moving according to the plan, as all batches of PRF-110 manufactured to date are in-line with expectations. Assuming we proceed as planned, we expect to manufacture the clinical batch by mid-2022.

“On the heels of the bunionectomy trial, we plan to commence our second Phase 3 trial for pain treatment in hernia. We believe our proprietary extended-release drug-delivery system has broad potential for a wide range of surgeries, as it 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.

“We have maintained a solid balance sheet and had $15.4 million of cash on hand and no debt as of March 31, 2022. As a result, we have more than sufficient capital to carry us through a number of key milestones, including the initiation of our first Phase 3 trial,” concluded Mr. Hadar.

Financial Results for the First Quarter Ended March 31, 2022

Research and development expenses were $680,000 for the three months ended March 31, 2022 compared to $1,029,000 for the three months ended March 31, 2021, a decrease of $349,000. The decrease was primarily due to a decrease in payment to subcontractors and clinical trials costs.

General and administrative expenses were $992,000 for the three months ended March 31, 2022 compared to $1,010,000 for the three months ended March 31, 2021, a decrease of $18,000. The decrease was primarily due a decrease in headcount related costs, a decrease in insurance costs and an increase in certain professional services costs.

Financial expense, net was $22,000 for the three months ended March 31, 2022 compared to financial expenses, net of $2,000 for the three months ended March 31, 2021, an increase of $20,000. The increase was primarily due to an increase of exchange rate costs.

As a result of the foregoing, the Company incurred a net loss of $1,694,000 for the three months ended March 31, 2022 compared to a net loss of $2,041,000 for the three months ended March 31, 2021, a decrease of $347,000.

As of March 31, 2022, the Company had cash and cash equivalents of $15.4 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

FAQ

What recent updates did PainReform (PRFX) announce regarding PRF-110?

PainReform announced successful batch manufacturing of PRF-110 and plans to commence Phase 3 clinical trials in the second half of 2022.

What are PainReform's financial results for Q1 2022?

For Q1 2022, PainReform reported a net loss of $1.694 million, down from $2.041 million in Q1 2021, with R&D expenses decreasing to $680,000.

How is PainReform's financial health as of March 31, 2022?

PainReform holds $15.4 million in cash with no debt, indicating a solid financial position to support ongoing development.

What is the significance of the FDA's 505(b)(2) approval for PainReform?

The FDA's approval for the 505(b)(2) pathway allows PainReform to conduct clinical trials for PRF-110 more rapidly and cost-effectively.