Core Insights - PainReform Ltd. has received partial topline data from its Phase 3 clinical trial for PRF-110, which is aimed at managing post-surgical pain in patients undergoing bunionectomy [1][2] - Initial analysis shows PRF-110 has statistically significant superiority over placebo in reducing pain during the first 48 hours post-surgery, indicating its potential effectiveness [2][4] - There are unresolved data issues regarding the subsequent 24-hour period, which is critical for assessing the primary endpoint of the trial [3] Company Overview - PainReform is a clinical-stage specialty pharmaceutical company focused on reformulating established therapeutics, with PRF-110 being its lead product based on ropivacaine [6] - PRF-110 is designed to provide prolonged pain relief while minimizing the need for opioids, potentially enhancing patient recovery and safety in post-surgical settings [4][6] Clinical Trial Details - The Phase 3 trial is a randomized, double-blind, placebo- and active-controlled study involving 428 patients, with PRF-110 administered intra-operatively [5] - The primary efficacy endpoint is the mean area under the curve (AUC) of pain intensity scores over 72 hours, with secondary endpoints including opioid consumption and the proportion of opioid-free subjects [5]

Core Viewpoint - PainReform Ltd. has received a notification from Nasdaq indicating it no longer meets the minimum stockholders' equity requirement for continued listing, but this has no immediate effect on its trading status [1][2]. Company Overview - PainReform is a clinical-stage specialty pharmaceutical company focused on reformulating established therapeutics, with its lead product PRF-110 targeting postoperative pain relief [3]. - PRF-110 is an oil-based, viscous solution designed for direct application into surgical wounds to provide localized and extended pain relief, potentially reducing the need for opiates [3]. Nasdaq Notification Details - The company has 45 days from the notification date to submit a plan to regain compliance with the Minimum Equity Rule or an alternative listing standard, with a deadline of December 19, 2024 [2]. - If the plan is accepted, Nasdaq may grant an extension of up to 180 days, allowing compliance to be achieved by May 3, 2025 [2].

Core Insights - PainReform Ltd. announced positive findings regarding the compatibility of its lead product PRF-110 with surgical sutures in human clinical trials, indicating its potential for extended, non-opiate post-surgical pain relief [1][4] Group 1: Product and Clinical Trials - PRF-110 is designed to provide extended post-surgical pain relief without the use of opiates, utilizing a proprietary extended-release drug-delivery system [5] - Comprehensive in vitro studies were conducted to assess the impact of PRF-110 on both nonabsorbable (PROLENE™) and resorbable (Vicryl™) sutures, focusing on mechanical properties such as breaking force and elongation [2] - Results showed that PRF-110 does not affect the mechanical properties of either type of suture, suggesting compatibility with surgical conditions [3] Group 2: Company Leadership and Future Directions - Ehud Geller, Chairman and interim CEO, emphasized the importance of these findings as a milestone for the safety and efficacy of PRF-110, advancing the product toward commercialization [4] - The ability to provide extended pain relief without compromising suture integrity is highlighted as a significant advancement in post-surgical care [4]

Core Viewpoint - PainReform Ltd. has entered into definitive agreements for the immediate exercise of outstanding warrants, allowing the purchase of up to 989,300 ordinary shares at a reduced exercise price of $1.60 per share, down from $4.80 per share [1][2]. Group 1: Financial Details - The gross proceeds from the exercise of the warrants are expected to be approximately $1.58 million, prior to deducting placement agent fees and estimated offering expenses [3]. - The company intends to use the net proceeds from the offering for general corporate purposes [3]. Group 2: New Warrants - In exchange for the immediate exercise of the warrants, the company will issue new unregistered warrants to purchase up to 1,978,600 ordinary shares, with an exercise price of $1.60 per share, exercisable immediately upon issuance and expiring five years from the date of issuance [2]. Group 3: Regulatory Information - The new warrants were offered in a private placement and have not been registered under the Securities Act of 1933, meaning they cannot be offered or sold in the U.S. without registration or an applicable exemption [4]. - The company has agreed to file a registration statement with the SEC covering the resale of the ordinary shares issuable upon exercise of the new warrants [4]. Group 4: Company Overview - PainReform is a clinical-stage specialty pharmaceutical company focused on reformulating established therapeutics, with its lead product PRF-110 targeting postoperative pain relief [6]. - PRF-110 is based on the local anesthetic ropivacaine and is designed to provide localized and extended postoperative analgesia without the need for repeated doses [6].

Exhibit 99.1 PAINREFORM LTD. CONDENSED FINANCIAL STATEMENTS AS OF JUNE 30, 2024 U.S. DOLLARS IN THOUSANDS UNAUDITED INDEX | | Page | | --- | --- | | Condensed Balance Sheets | F-2 | | Condensed Statements of Comprehensive Loss | F-3 | | Condensed Statements of Changes in Shareholders' (Deficit) Equity | F-4 | | Condensed Statements of Cash Flows | F-5 | | Notes to Condensed Financial Statements | F-6 - F-12 | PAINREFORM LTD. CONDENSED BALANCE SHEETS (Unaudited) U.S. dollars in thousands U.S. dollars in thou ...

TEL AVIV, Israel, Aug. 07, 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 compelling safety data for its lead product candidate, PRF-110. This data, derived from pharmacokinetic (PK) studies in both herniorrhaphy and bunionectomy clinical trials, highlights PRF-110's promising safety profile, with maximum blood levels (Cmax) recorded at approxi ...

TEL AVIV, Israel, Aug. 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, announces a major advancement in the development of its lead asset, PRF-110. The Company's new highly scalable manufacturing process, for which it recently filed a new patent, has enabled PRF-110 to achieve full product stability for 18 months at room temperature. This stability study is ...

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 ...

TEL AVIV, Israel, June 26, 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 a major milestone on the way to registration - the successful completion of patient enrollment in its Phase 3 clinical trial for PRF-110, a novel analgesic drug candidate designed for the treatment of post-operative pain. In total, 428 patients have been enrolled at eight ...

TEL AVIV, Israel, May 31, 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 that the Company received a letter from the Nasdaq Listing Qualifications (the "Letter"), indicating that the Company is not in compliance with the minimum bid price requirement for continued listing set forth in Listing Rule 5550(a)(2), which requires listed securities to ...