0001178913-22-003581.txt : 20221004 0001178913-22-003581.hdr.sgml : 20221004 20221004102151 ACCESSION NUMBER: 0001178913-22-003581 CONFORMED SUBMISSION TYPE: 6-K PUBLIC DOCUMENT COUNT: 3 CONFORMED PERIOD OF REPORT: 20221004 FILED AS OF DATE: 20221004 DATE AS OF CHANGE: 20221004 FILER: COMPANY DATA: COMPANY CONFORMED NAME: PAINREFORM LTD. CENTRAL INDEX KEY: 0001801834 STANDARD INDUSTRIAL CLASSIFICATION: PHARMACEUTICAL PREPARATIONS [2834] IRS NUMBER: 000000000 STATE OF INCORPORATION: L3 FISCAL YEAR END: 1231 FILING VALUES: FORM TYPE: 6-K SEC ACT: 1934 Act SEC FILE NUMBER: 001-39481 FILM NUMBER: 221290033 BUSINESS ADDRESS: STREET 1: 65 YIGAL ALON ST. CITY: TEL AVIV STATE: L3 ZIP: 6744316 BUSINESS PHONE: 972-3-7177051 MAIL ADDRESS: STREET 1: 65 YIGAL ALON ST. CITY: TEL AVIV STATE: L3 ZIP: 6744316 6-K 1 zk2228535.htm 6-K


UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
 
Form 6-K
 
Report of Foreign Private Issuer
 
Pursuant to Rule 13a-16 or 15d-16
of the Securities Exchange Act of 1934
 
For the month of October 2022
 
Commission File Number: 001-39481
 
PainReform Ltd.
(Translation of registrant’s name into English)
 
4 Bruria St. Tel Aviv, 6745442
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): ____


On October 4, 2022, PainReform Ltd. issued a press release entitled “PainReform Provides PRF-110 Manufacturing Update”. A copy of the press release is attached hereto as Exhibit 99.1 and incorporated herein by reference.
 
Exhibit Index
 
Exhibit No.
 
Description

 

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: October 4, 2022
PAINREFORM LTD.
 
 
 
By:
/s/ Ilan Hadar
 
 
Ilan Hadar
 
 
Chief Executive Officer
 

EX-99.1 2 exhibit_99-1.htm EXHIBIT 99.1

Exhibit 99.1


PainReform Provides PRF-110 Manufacturing Update

Completed tech transfer to CMO resulting in new process improvements

On track to commence Phase 3 clinical trial in bunionectomy in November 2022

Tel Aviv, Israel – October 4, 2022 – PainReform Ltd. (Nasdaq: PRFX) ("PainReform" or the "Company"), a clinical-stage specialty pharmaceutical company focused on the reformulation of established therapeutics, today provided an update regarding the added benefits in its PRF-110 manufacturing process. This new process is expected to not only aid the manufacturing of clinical stock for the Phase 3 clinical study about to begin, but also deliver benefits into the future.
 
Ilan Hadar, Chief Executive Officer of Pain Reform, stated, “The process improvements we achieved will further enhance efficiency, scalability and other aspects of the manufacturing process. Among these improvements was the addition of terminal filtration for PRF-110, which we believe will help ensure the highest quality batch production, as well as support our planned commercial manufacturing.  I’m also pleased to report we remain on track to commence our Phase 3 clinical trial in bunionectomy in November 2022 and look forward to providing further updates.”
 
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. For more information, please visit www.painreform.com.
 

Notice Regarding Forward-Looking Statements
This press release contains forward looking statements about our expectations, beliefs and intentions. Forward-looking statements can be identified by the use of forward-looking words such as "believe", "expect", "intend", "plan", "may", "should", "could", "might", "seek", "target", "will", "project", "forecast", "continue" or "anticipate" or their negatives or variations of these words or other comparable words or by the fact that these statements do not relate strictly to historical matters. These forward-looking statements are based on assumptions and assessments made in light of management's experience and perception of historical trends, current conditions, expected future developments and other factors believed to be appropriate. Forward-looking statements in this press release are made as of the date of this press release, and we undertake no duty to update or revise any such statements, whether as a result of new information, future events or otherwise. Forward-looking statements are not guarantees of future performance and are subject to risks and uncertainties, many of which are outside of our control. Many factors could cause our actual activities or results to differ materially from the activities and results anticipated in forward- looking statements, including, but not limited to, the following: our history of significant losses, our need to raise additional capital and our ability to obtain additional capital on acceptable terms, or at all; our dependence on the success of our initial product candidate, PRF-110; the outcomes of preclinical studies, clinical trials and other research regarding PRF-110 and future product candidates;  the impact of the COVID-19 pandemic on our operations; our limited experience managing clinical trials; our ability to retain key personnel and recruit additional employees; our reliance on third parties for the conduct of clinical trials, product manufacturing and development; the impact of competition and new technologies; our ability to comply with regulatory requirements relating to the development and marketing of our product candidates; commercial success and market acceptance of our product candidates; our ability to establish sales and marketing capabilities or enter into agreements with third parties and our reliance on third party distributors and resellers;  our ability to establish and maintain strategic partnerships and other corporate collaborations; the implementation of our business model and strategic plans for our business and product candidates; the scope of protection we are able to establish and maintain for intellectual property rights and our ability to operate our business without infringing the intellectual property rights of others; the overall global economic environment; our ability to develop an active trading market for our ordinary shares and whether the market price of our ordinary shares is volatile; and statements as to the impact of the political and security situation in Israel on our business. More detailed information about the risks and uncertainties affecting us is contained under the heading "Risk Factors" included in the Company's most recent Annual Report on Form 20-F and in other filings that we have made and may make with the Securities and Exchange Commission in the future.

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


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