PainReform Provides Business Update for the Third Quarter of 2022

Rhea-AI Summary

PainReform Ltd. (Nasdaq: PRFX) provided a business update for Q3 2022, focusing on PRF-110, a product for post-operative pain relief following bunionectomy surgery. The company made enhancements to its manufacturing process, leading to delays in starting the Phase 3 clinical trial but aims to rectify the issue. As of September 30, 2022, it reported $12.9 million in cash, supporting upcoming milestones. R&D expenses increased to $2.5 million, while net loss rose slightly to $5.6 million. PainReform plans to initiate another Phase 3 trial for pain treatment in hernia repair surgery.

Positive

• Company has $12.9 million in cash, allowing execution on key milestones.
• Enhancements to PRF-110 manufacturing process expected to improve product quality.
• Plans to initiate a second Phase 3 trial for pain treatment in hernia repair surgery.

Negative

• Delay in starting the Phase 3 clinical trial for PRF-110 due to manufacturing issues.
• Net loss increased to $5.6 million for nine months ended September 30, 2022.

Implements Technology Improvements Related to PRF-110 Manufacturing Process Ahead of Planned Phase 3 Clinical Trial in Bunionectomy

TEL AVIV, Israel, Nov. 15, 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 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

FAQ

What is the latest update on PainReform's PRF-110 clinical trial?

PainReform is making progress toward commencing the Phase 3 clinical trial for PRF-110 but has encountered manufacturing delays.

How much cash does PainReform have as of September 30, 2022?

As of September 30, 2022, PainReform reported approximately $12.9 million in cash and deposits.

What were PainReform's financial results for the nine months ended September 30, 2022?

PainReform incurred a net loss of $5.6 million, slightly up from $5.5 million for the same period in 2021.

What are the future plans for PainReform in 2023?

PainReform plans to initiate a second Phase 3 trial for pain treatment in hernia repair surgery after the bunionectomy trial.

What improvements are being made to the PRF-110 manufacturing process?

The company has implemented enhancements to improve the manufacturability and quality of PRF-110.