Painreform Ltd Stock Price, News & Analysis

PainReform (Nasdaq: PRFX) provided an update on its Phase 3 clinical trial of PRF-110 for post-surgical pain management in bunionectomy patients. While the trial showed statistically significant superiority over placebo in pain reduction during the first 48 hours post-surgery, the company revealed that data from the final 24-hour period could not be clarified to meet the study's primary endpoint 72-hour requirement. As a result, the trial did not achieve its primary endpoint.

The company has initiated R&D activities to better understand and refine PRF-110's pharmaco-kinetics and pharmaco-dynamics based on study data. Management plans to use high-level, in-vitro models to address the 72-hour requirement issue before conducting additional clinical work. The company is also reviewing strategic options.

PainReform (Nasdaq: PRFX) announced partial topline data from its Phase 3 clinical trial of PRF-110 for post-surgical pain management in bunionectomy patients. The initial analysis shows statistically significant superiority over placebo in pain reduction during the first 48 hours post-surgery. However, data for the subsequent 24-hour period, important for the primary endpoint assessment, remains unclear due to data incoherence. The company is working with Lotus Clinical Research to resolve these data issues. PRF-110 is an oil-based, extended-release formulation of ropivacaine, designed to provide prolonged pain relief while reducing opioid dependency.

PainReform (Nasdaq: PRFX) has received a notification from Nasdaq regarding non-compliance with the minimum stockholders' equity requirement. The company no longer meets the $2.5 million stockholders' equity threshold, the $35 million market value requirement, or the alternative $500,000 net income criteria. PainReform has until December 19, 2024, to submit a compliance plan to Nasdaq. If accepted, the company may receive an extension until May 3, 2025, to regain compliance. The notification does not immediately affect the listing or trading of shares on the Nasdaq Capital Market.

PainReform (Nasdaq: PRFX) has announced positive results regarding the compatibility of sutures in human clinical trials for its lead product, PRF-110. The company conducted in vitro studies to assess the impact of PRF-110 on both non-absorbable and resorbable sutures, specifically PROLENE™ and Vicryl™. The results showed that PRF-110 does not affect the mechanical properties of these sutures, including breaking force and elongation, after 14 days of exposure.

This finding is consistent with the phase III clinical results from the bunionectomy trial and supports the safety and efficacy of PRF-110 in post-surgical pain management. The compatibility of PRF-110 with surgical sutures is a significant advancement in post-operative care, as it allows for extended, non-opiate pain relief without compromising suture integrity.

PainReform (Nasdaq: PRFX), a clinical-stage pharmaceutical company, has announced agreements for the immediate exercise of outstanding warrants. These warrants, originally issued in December 2023 and April 2024, will purchase up to 989,300 ordinary shares at a reduced price of $1.60 per share, down from the original $4.80. The offering is expected to close around September 11, 2024.

In exchange for this exercise, PainReform will issue new unregistered warrants for up to 1,978,600 ordinary shares, exercisable immediately at $1.60 per share and expiring in five years. The company anticipates gross proceeds of approximately $1.58 million from this transaction, which will be used for general corporate purposes. H.C. Wainwright & Co. is acting as the exclusive placement agent for this offering.

PainReform (Nasdaq: PRFX) has successfully determined the optimal delivery method for PRF-110 in bunionectomy procedures, marking a significant milestone in advancing post-surgical pain management. Phase III evaluations have demonstrated PRF-110's superior physical properties, ensuring optimal coverage of cut nerve endings and traumatized tissue surfaces.

Key findings include effective wound coverage, competitive advantages over leading products, enhanced viscosity and uniformity, and precision delivery coverage. PRF-110 exhibited superior adhesion and location adherence compared to competitors, maintaining effectiveness even in the presence of physiological fluids. The product's optimal viscosity and uniformity facilitated ease of application and even distribution across the wound bed.

PainReform (Nasdaq: PRFX) has announced positive early safety results from its ongoing Phase 3 bunionectomy study of PRF-110, a proprietary post-surgical pain formulation. The study, which has completed full enrollment with 443 patients across eight U.S. clinical sites, revealed a low incidence of adverse events, averaging just one per subject.

PRF-110 is positioned as a potential non-opioid alternative in the $12 billion post-operative pain market. The company's Chairman and interim CEO, Ehud Geller, expressed optimism about PRF-110's potential to be a game-changer in post-surgical pain management. The formulation leverages the established safety of ropivacaine and GRAS components, supporting its promising safety profile.

PainReform (Nasdaq: PRFX) has provided a business update for Q2 2024, highlighting significant progress in the clinical development of PRF-110, their lead drug candidate for post-operative pain relief. Key achievements include:

1. Full enrollment (443 patients) in the second part of Phase 3 clinical trial for bunionectomy
2. Favorable wound healing data from human clinical trials
3. Promising PK study results showing safe limits
4. New patent filed for a highly scalable manufacturing process
5. Development of new formulations combining PRF-110 with anti-inflammatory agents

Financial results show increased R&D expenses of $11.4 million, primarily due to the Phase 3 trial. The company's net loss increased to $12.8 million. As of June 30, 2024, PainReform had $2.8 million in cash and cash equivalents, with an additional $4 million raised in April 2024 through a public offering.

PainReform (Nasdaq: PRFX) has successfully developed and manufactured new patented formulations of its extended postoperative pain relief therapy, PRF-110. These formulations combine ropivacaine, a local anesthetic, with dexamethasone, an anti-inflammatory agent, to enhance postoperative recovery and pain management.

The company has created specific combination products containing 3.6% or 3.0% ropivacaine and 0.1-0.5% dexamethasone, which have shown promising stability in ongoing studies. This unique formulation addresses the challenge of product stability in ropivacaine-steroid mixtures.

PainReform's approach aims to provide superior pain management by combining the analgesic effects of ropivacaine with the anti-inflammatory properties of dexamethasone, potentially reducing reliance on opioids post-operatively.