PainReform Provides Year-End Business Update

Reports continued enrollment in the second part of the Phase 3 clinical trial in bunionectomy

Remains on track to announce top-line data by mid-2024

TEL AVIV, Israel, March 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, today provided a business update for the year ended December 31, 2023.

Ilan Hadar, Chief Executive Officer of PainReform, stated, “We are pleased to report significant progress this past year advancing PRF-110, our lead drug candidate for post-operative extended pain relief, thereby reducing the potential need for the use of opiates. Building on the success of the first part of our Phase 3 clinical trial of PRF-110, we are moving forward steadily with our enrollment. We have now enrolled over 140 patients in the trial, out of our target, of up to 400 patients at six clinical sites across the U.S. As a result, we remain on track to announce topline data around mid-2024. Moreover, we are pleased with the positive results of the recent in vitro tests, which further demonstrated the superior formulation properties of PRF-110 compared to the industry leader, with respect to surface-tissue spreading. Overall, we remain highly encouraged by the outlook for PRF-110 and our ongoing clinical trial given the positive PK data in the first part of our Phase 3 trial, as well as our prior Phase 2 data in hernia repair, confirming the safety and quality of our product as an alternative to systemic opioids. For these reasons, we remain confident PRF-110 has the potential to become standard-of-care within the $12 billion post-operative pain treatment market.”

Financial Results for the Year Ended December 31, 2023

Research and development expenses were approximately $6.0 million for the year ended December 31, 2023, compared to approximately $4.4 million for the year ended December 31, 2022. The increase was primarily due to an increase in payments for clinical trial costs and manufacturing costs that were offset by a decrease in subcontractors and consultants’ expenses.

General and administrative expenses were approximately $3.6million for the year ended December 31, 2023, compared to approximately $4.4 million for the year ended December 31, 2022. The decrease was mainly in insurance costs and certain professional services costs.

Financial income, net, was approximately $248,000 for the year ended December 31, 2023, compared to financial income, net, of approximately $86,000 for the year ended December 31, 2022. The increase was primarily due to financial income resulting from a change in the valuation of warrants that were issued in 2023 and interest income from bank deposits, which was offset by losses from warrant issuance and issuance costs.