6-K
PRF Technologies Ltd. (PRFX)
UNITEDSTATES
SECURITIESAND EXCHANGE COMMISSION
Washington,D.C. 20549
Form6-K
Reportof Foreign Private Issuer
Pursuantto Rule 13a-16 or 15d-16
ofthe Securities Exchange Act of 1934
For the month of January, 2021
Commission File Number: 001-39481
PainReformLtd.
(Translation of registrant’s name into English)
60C Medinat Hayehudim
Herzliya, 4676670
Israel
(Address of principal executive offices)
Indicate by check mark whether the registrant files or will file annual reports under cover Form 20-F or Form 40-F.
Form 20-F ☒ Form 40-F ☐
Indicate by check mark if the registrant is submitting the Form 6-K in paper as permitted by Regulation S-T Rule 101(b)(1): ____
Indicate by check mark if the registrant is submitting the Form 6-K in paper as permitted by Regulation S-T Rule 101(b)(7): ____
PainReform Ltd.
Explanatory Note
On January 4, 2021, PainReform Ltd. (the “Company”) issued a press release titled: “PainReform Announces Appointment of Lotus Clinical Research as CRO for Phase 3 Clinical Trial of PRF-110”.
A copy of this press release is furnished herewith as Exhibit 99.1 and incorporated herein by reference.
Investors and others should note that the Company may announce material information about its finances, product candidates, clinical trials and other matters to its investors using its website (https://www.painreform.com/) in addition to SEC filings, press releases, public conference calls and webcasts. The Company uses these channels to communicate with the Company’s shareholders and the public about the Company and other issues. It is possible that the information the Company posts on these channels could be deemed to be material information. Therefore, the Company encourages investors, the media, and others interested in the Company to review the information it posts on the Company’s website (referenced above) in addition to following its press releases, SEC filings, public conference calls, and webcasts.
1
SIGNATURES
Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned, thereunto duly authorized.
| Date: January 4,<br> 2021 | PAEFORM LTD. |
|---|---|
| By: | |
All values are in Indian Rupees.
2
Exhibit 99.1
PainReform Announces Appointment of LotusClinical Research as CROfor Phase 3 Clinical Trial of PRF-110
Reports steady progress towards start ofPhase 3 trial
HERZLIYA, Israel – January 4, 2021– PainReform Ltd. (NasdaqCM: PRFX) (“PainReform” or the “Company”), a clinical-stage specialty pharmaceutical company focused on the reformulation of established pain drugs, today announced the appointment of Lotus Clinical Research (“LCR”) as its clinical research organization (“CRO”) to conduct the Company’s upcoming Phase 3 trial of PRF-110 in patients undergoing bunionectomy and hernia repair operations and the entering into an agreement with Lotus covering such trials.
LCR is a specialty analgesic focused CRO with a proven track record of conducting successful, full-service analgesic studies from startup through all phases of analgesic clinical trials. LCR has its own clinical sites that support all phases of clinical trials for novel analgesics and specifically in the area of post-operative pain, including bunion and hernia. LCR has developed an acute pain model that offers numerous advantages over traditional models, providing clients with active engagement and recruitment of study subjects, on-site accessibility of surgical and recovery services, and lowered project costs throughout a study’s lifecycle. LCR has been involved in approximately 350 pain trials that led to over ten approvals.
PainReform has been working with LCR’s Chief Scientific Officer, Dr. Neil Singla, for over two years in planning these trials. Dr. Singla is a nationally recognized key opinion leader in analgesic protocol design and implementation. He has published extensively and is a frequent lecturer for physicians, pharmaceutical companies, and medical research institutes throughout the country. For the past several years, the main focus of Dr. Singla's academic endeavors has been to analyze and understand how the inherent variability in subjective endpoint clinical trials can be minimized. He has developed novel techniques for patient education designed to minimize variability, reduce placebo response, and increase effect size.
Ilan Hadar, CEO of PainReform, noted, “We are delighted to announce the appointment of LCR as our CRO, which marks another important milestone as we prepare to commence our pivotal Phase 3 trials for PRF-110. LCR brings extensive and unique expertise in conducting analgesic studies, which we believe will help ensure a swift and efficient trial. Moreover, Dr. Singla is one of the preeminent experts in the world on analgesic protocol design. We remain highly encouraged by our prior data, which demonstrated a strong safety profile, suggesting a substantial advantage to using PRF-110 over the local anesthetic, ropivacaine. For this reason, we believe PRF-110 addresses an important unmet need in the market, especially as an alternative to systemic opioids, which have contributed to the opioid epidemic.”
Dr. Neil Singla, Chief Scientific Officer of LCR, commented, “We are honored to work with PainReform to advance this important study. PRF-110 holds significant potential as an alternative to systemic opioids and offers numerous advantages over other topical pain relief therapies. PRF-110 demonstrated pain relief of up to 72 hours in a Phase 2 clinical study in hernia patients. Importantly, opiate abuse and addiction cause 70,000 deaths annually in the US alone and an economic burden of $80 billion per year. We believe the trial is well designed, and we look forward to supporting the administration of this trial.”
As previously reported, PRF-110 provided substantial pain reduction for up to 72 hours post-operatively the in the Company’s prior Phase 2 proof-of-concept clinical study in herniorrhaphy (hernia repair). A comparison of these results to historical data for ropivacaine alone suggests a substantial advantage to using PRF-110 over the local anesthetic, ropivacaine, alone. As indicated in the FDA approved drug description for ropivacaine, such drug provides pain relief for only 2 to 6 hours. The surgeons that participated in the PRF-110 Phase 2 trial reported that it was easily integrated into the procedure and non-disruptive of existing surgical techniques. Ropivacaine, the active drug used in PRF-110, is a safe, well-tolerated, and well-characterized local anesthetic, and the other components that make up the remainder of the PRF-110 formulation are classified as GRAS by the FDA, mitigating many potential safety issues that are common in drug development.
About PainReform
PainReform is a clinical-stage specialty pharmaceutical company focused on the reformulation of established therapeutics. PRF-110, the Company’s lead product, is based on the local anesthetic ropivacaine, targeting the post-operative pain relief market. PRF-110 is an oil-based, viscous, clear solution that is deposited directly into the surgical wound bed prior to closure to provide localized and extended post-operative analgesia. The Company’s proprietary extended-release drug-delivery system is designed to provide an extended period of post-surgical pain relief without the need for repeated dose administration while reducing the potential need for the use of opiates.
Notice Regarding Forward-Looking Statements
This press release contains certain forward-lookingstatements, including statements with regard to PainReform’s proposed clinical trials. Words such as “expects,”“anticipates” and “intends” or similar expressions are intended to identify forward-looking statements.These forward-looking statements are subject to the inherent uncertainties in predicting future results and conditions, and noassurance can be given that the clinical trials discussed above will be successfully completed. Completion of the proposed clinicaltrials are subject to numerous factors, many of which are beyond the control of the Company, including, without limitation, failureof the clinical trials, and the risk factors and other matters set forth in the Company’s recent prospectus included in theregistration statement, in the form last filed with the SEC. PainReform undertakes no obligation to publicly update or revise anyforward-looking statements, whether as a result of new information, future events or otherwise, except as may be required by law.
Contact:
Crescendo Communications, LLC
Tel: 212-671-1021
Email: prfx@crescendo-ir.com
Ilan Hadar
Chief Executive Officer
PainReform Ltd.
Tel: +972-54-5331725
Email: ihadar@painreform.com