aibioPainReform (now PRF Technologies) says Nasdaq found it compliant with Rule 5550(b)(1)
Tickers PRFX
Nasdaq found PainReform complies with Rule 5550(b)(1), but warned that delisting could follow if the next periodic report does not show compliance.
Key facts
- Company
- PRF Technologies Ltd. (NASDAQ: PRFX)
- News type
- Listings
- Primary source
- PRF Technologies Ltd. 6-K (2025-04-17)
What the notice says
PainReform Ltd., now PRF Technologies Ltd. (Nasdaq: PRFX), said in a Form 6-K dated April 17, 2025 that Nasdaq has determined the company complies with Nasdaq Listing Rule 5550(b)(1). The filing is a short notice. It recalls that the company announced in a Form 6-K filed on November 7, 2024 that it had received a notification letter from the Listing Qualifications Staff of The Nasdaq Stock Market LLC, which said the company was not in compliance with the same rule.
On April 16, 2025, Nasdaq told the company that, based on the Form 6-K the company filed on April 14, 2025, it had determined the company complies with Listing Rule 5550(b)(1). The 6-K does not say which measure the company met, and it gives no figures for the company's equity or cash.
A condition remains
The cure is not final. The company states that if it fails to evidence compliance when it files its next periodic report, it may be subject to delisting. At that time the Staff will provide written notification, and the company may then appeal the Staff's determination to a Hearings Panel. In other words, Nasdaq has accepted the April 14 filing, but the listing question comes back with the next report.
Ehud Geller signed the 6-K as Executive Chairman of the Board and Interim Chief Executive Officer. The report is incorporated by reference into the company's Form S-8 and Form F-3 registration statements.
The business behind the listing
The company's annual report on Form 20-F, filed April 7, 2025, describes a specialty pharmaceutical company focused on the reformulation of established therapeutics. Its proprietary extended-release drug-delivery system is designed to provide an extended period of post-surgical pain relief without repeated dosing, while reducing the potential need for opiates. The report adds that in March 2025 the company acquired the business operations of DeepSolar, an AI-driven solar analytics technology.
The company was incorporated under Israeli law in November 2007 under the name PainReform Ltd. Its principal executive offices are at 65 Yigal Alon St., Tel Aviv. It describes itself as an emerging growth company and a foreign private issuer. The 20-F says it will remain an emerging growth company until the earliest of several tests, one of which falls on December 31, 2025. As a foreign private issuer it says it will not be required to issue quarterly reports or to file current reports as frequently as U.S. domestic companies.
The drug program
The strategy is to combine generic drugs with the proprietary delivery system and use the 505(b)(2) regulatory pathway, under which FDA can approve a new drug based in part on data developed by others, including published literature. The first product candidate, PRF-110, is based on the local anesthetic ropivacaine and targets post-operative pain relief. The 20-F describes PRF-110 as an oil-based, viscous, clear solution deposited directly into the surgical wound bed before closure.
The clinical evidence is small. The company reports a 15-patient Phase 2 proof-of-concept study in hernia repair in which PRF-110 provided substantial pain reduction for up to 72 hours after surgery. It supports the claim of an advantage by comparing those results with historical data for ropivacaine alone, not with a head-to-head result. The 20-F notes that FDA-approved labeling says ropivacaine provides pain relief for only 2 to 6 hours. The company also says the surgeons in the trial found the product easy to integrate into the procedure and non-disruptive.
On safety, the company says ropivacaine is a safe and well-characterized local analgesic and that the other components of the formulation are classified as GRAS, or Generally Regarded As Safe, by FDA. That is the company's characterization, not an FDA finding.
What happens next
The next test is the company's next periodic report, which must evidence compliance to avoid a delisting notice. If a notice came, the company could appeal to a Hearings Panel. The 6-K gives no date for that report and no outline of how the company plans to show compliance.