PainReform Ltd. Ordinary Shares - PRFX STOCK NEWS

PainReform (Nasdaq: PRFX) has filed a patent for a new, highly scalable manufacturing process for PRF-110, its flagship post-operative pain control product. This development follows successful completion and testing of the process, marking a significant step towards potential market launch. The improved process includes:

• Continuous Process Manufacturing for increased productivity
• Single Reactor Manufacturing for reduced costs and contamination risk
• Enhanced Batch Size capabilities while maintaining quality

These improvements are expected to reduce production costs and COGS for PRF-110. The company has completed its bunionectomy Phase 3 trial and believes PRF-110 could set a new standard in non-opioid post-operative pain relief.

PainReform has successfully completed patient enrollment for the second part of its Phase 3 clinical trial for PRF-110, a novel analgesic drug candidate aimed at treating post-operative pain. The double-blind, placebo-controlled study enrolled 428 patients across eight U.S. sites. The trial's primary endpoint is to determine the drug's efficacy in reducing post-operative pain intensity over 72 hours compared to a placebo. Secondary endpoints include comparisons with Naropin and assessments of safety and rescue analgesic use. The company anticipates reporting top-line data in the second half of 2024, a critical step towards regulatory submission and potential commercialization.

PainReform, a clinical-stage specialty pharmaceutical company, announced it received a notification from Nasdaq indicating non-compliance with the minimum bid price requirement of $1.00 per share set forth in Listing Rule 5550(a)(2). The company has 180 days, from May 28, 2024, to November 25, 2024, to regain compliance by maintaining a closing bid price of at least $1 for a minimum of ten consecutive business days. Failure to do so may result in delisting, although the company may be eligible for an additional compliance period if it meets other listing standards. The notification does not immediately affect PainReform’s Nasdaq listing or trading under the symbol 'PRFX'.

PainReform provided a business update for Q1 2024, noting significant progress in the clinical development of its lead drug candidate, PRF-110.

The company reached 50% enrollment in the second part of its Phase 3 clinical trial for PRF-110 in bunionectomy, with over 200 patients enrolled across eight U.S. sites. No serious adverse events have been reported.

PainReform expects to announce top-line data in Q3 2024. New studies showed PRF-110's superior in-vitro release rates compared to industry leaders, and the company is optimistic about its potential to reduce opioid use.

Financially, R&D expenses rose to $4.7 million, mainly due to the Phase 3 trial, while general and administrative expenses decreased to $823,000. The company incurred a net loss of $5.5 million. As of March 31, 2024, PainReform held $4.3 million in cash and raised $4 million through a public offering in April 2024.

PainReform CEO, Ilan Hadar, discussed the benefits of PRF-110 in addressing the opioid epidemic during an interview with Proactiveinvestors.com. PRF-110 offers extended post-operative pain relief without opioids, with positive updates on the Phase 3 trial and market potential.

PainReform, a clinical-stage specialty pharmaceutical company, announced the closing of a $4 million public offering, issuing 5,000,000 ordinary shares and warrants. The offering price was $0.80 per share with warrants exercisable immediately at the same price, expiring in five years. H.C. Wainwright & Co. acted as the exclusive placement agent. The net proceeds will be used for advancing clinical studies and general corporate purposes. The company also amended existing warrants to reduce the exercise price to $0.80 per share.

PainReform (Nasdaq: PRFX) has announced the pricing of a $4 million public offering, consisting of 5,000,000 ordinary shares and warrants. The offering is priced at $0.80 per share with accompanying warrants to purchase additional shares.

PainReform (Nasdaq: PRFX) announces groundbreaking results from studies showing superior in-vitro release rates of PRF-110 for post-surgical pain management. PRF-110 released 34%-77% more drug over 96 hours compared to industry leaders, promising extended pain relief and reduced opiate dependency.

PainReform (Nasdaq: PRFX) achieves 50% enrollment in Phase 3 clinical trial for PRF-110 in bunionectomy. No serious adverse events reported. Top-line data expected by mid-2024.