PainReform Provides Business Update for the First Quarter of 2024

Reaches 50% enrollment in the second part of its Phase 3 clinical trial of PRF-110 in bunionectomy

Remains on track to announce top-line data in Q3 2024

TEL AVIV, Israel, May 15, 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 first quarter ended March 31, 2024.

Ilan Hadar, Chief Executive Officer of PainReform, stated, “We are pleased to report a number of recent milestones as we advance the clinical development of PRF-110, our lead drug candidate, targeting the post-operative extended pain relief market. Importantly, we recently reached the 50% enrollment target for the second part of Phase 3 clinical trial of PRF-110 in bunionectomy. In total, over 200 patients have been enrolled at eight clinical sites across the U.S. Moreover, there have been no reported product related serious adverse events, highlighting PRF-110’s favorable safety profile to date. Building on the success of the first part of our Phase 3 clinical trial of PRF-110, we are moving forward steadily to wrap up enrollment and looking forward to sharing the preliminary top-line results in Q3 2024.”

“In addition, we reported positive results from new studies, which demonstrated the superior in-vitro release (IVR) rates of PRF-110 as compared to the industry leader for topical post-surgical pain management products. These findings underscore our commitment to advancing long-lasting, best-in-class pain management solutions while reducing the potential need for the use of opiates.”

“Overall, we remain highly encouraged by the outlook for our ongoing Phase 3 clinical trial, given the successful first part of our Phase 3 trial, as well as our prior Phase 2 data in hernia repair. As a result, we remain confident PRF-110 has the potential to redefine the standard of care in the multi-billion dollar postoperative pain management market, by offering patients what we believe will be a far better alternative to systemic opioids, as we aim to tackle the global opioid epidemic.”

Financial Results for the First Quarter Ended March 31, 2024

Research and development expenses were $4.7 million for the three months ended March 31, 2024, compared to $1.5 million for the three months ended March 31, 2023, an increase of $3.2 million. The increase in research and development expenses was primarily due to the expenses leading to the commencement of the Company’s Phase 3 trial.