<SEC-DOCUMENT>0001178913-23-001950.txt : 20230518
<SEC-HEADER>0001178913-23-001950.hdr.sgml : 20230518
<ACCEPTANCE-DATETIME>20230518091026
ACCESSION NUMBER:		0001178913-23-001950
CONFORMED SUBMISSION TYPE:	6-K
PUBLIC DOCUMENT COUNT:		3
CONFORMED PERIOD OF REPORT:	20230518
FILED AS OF DATE:		20230518
DATE AS OF CHANGE:		20230518

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:		23933830

	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
</SEC-HEADER>
<DOCUMENT>
<TYPE>6-K
<SEQUENCE>1
<FILENAME>zk2329762.htm
<DESCRIPTION>6-K
<TEXT>
<html>
  <head>
    <title></title>
    <!-- Licensed to: ZKG
         Document created using Broadridge PROfile 23.3.1.5138
         Copyright 1995 - 2023 Broadridge -->
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<body bgcolor="#ffffff" style="font-family: 'Times New Roman', Times, serif; font-size: 10pt; text-align: left; color: #000000;">
  <div>
    <hr align="center" style="border: none; border-bottom: 1px solid black; border-top: 4px solid black; height: 10px; color: #ffffff; background-color: #ffffff; text-align: center; margin-left: auto; margin-right: auto;">
    <div>
      <div style="text-align: center; line-height: 1.25; font-family: 'Times New Roman',Times,serif; font-size: 14pt; font-weight: bold; background-color: rgb(255, 255, 255); color: rgb(0, 0, 0); font-style: normal; font-variant: normal; text-transform: none;">UNITED STATES</div>
      <div style="text-align: center; line-height: 1.25; font-family: 'Times New Roman',Times,serif; font-size: 14pt; font-weight: bold; background-color: rgb(255, 255, 255); color: rgb(0, 0, 0); font-style: normal; font-variant: normal; text-transform: none;">SECURITIES AND EXCHANGE COMMISSION</div>
      <div style="text-align: center; line-height: 1.25; font-weight: bold;">Washington, D.C. 20549</div>
      <div style="text-align: center; line-height: 1.25;">&#160;</div>
      <div style="text-align: center; line-height: 1.25; font-family: 'Times New Roman',Times,serif; font-size: 14pt; font-weight: bold; background-color: rgb(255, 255, 255); color: rgb(0, 0, 0); font-style: normal; font-variant: normal; text-transform: none;">Form 6-K</div>
      <div style="text-align: center; line-height: 1.25; font-weight: bold;">&#160;</div>
      <div style="text-align: center; line-height: 1.25; font-weight: bold;">Report of Foreign Private Issuer</div>
      <div style="text-align: center; line-height: 1.25; font-weight: bold;">&#160;</div>
      <div style="text-align: center; line-height: 1.25; font-weight: bold;">Pursuant to Rule 13a-16 or 15d-16</div>
      <div style="text-align: center; line-height: 1.25; font-weight: bold;">of the Securities Exchange Act of 1934</div>
      <div style="text-align: center; line-height: 1.25;">&#160;</div>
      <div style="text-align: center; line-height: 1.25;">For the month of May 2023</div>
      <div style="text-align: center; line-height: 1.25;">&#160;</div>
      <div style="text-align: center; line-height: 1.25;">Commission File Number: 001-39481</div>
      <div style="text-align: center; line-height: 1.25;">&#160;</div>
      <div style="text-align: center; line-height: 1.25; font-family: 'Times New Roman',Times,serif; font-size: 16pt; font-weight: bold; background-color: rgb(255, 255, 255); color: rgb(0, 0, 0); font-style: normal; font-variant: normal; text-transform: none;">PainReform Ltd.</div>
      <div style="text-align: center; line-height: 1.25;">(Translation of registrant&#8217;s name into English)</div>
      <div style="text-align: center; line-height: 1.25;">&#160;</div>
      <div style="text-align: center; line-height: 1.25;">65 Yigal Alon St., Tel Aviv 6744316</div>
      <div style="text-align: center; line-height: 1.25;">Israel</div>
      <div style="text-align: center; line-height: 1.25;">(Address of principal executive offices)</div>
      <div style="text-align: center; line-height: 1.25;">&#160;</div>
      <div style="text-align: justify; line-height: 1.25;">Indicate by check mark whether the registrant files or will file annual reports under cover Form 20-F or Form 40-F.</div>
      <div style="text-align: justify; line-height: 1.25;">&#160;</div>
      <div style="text-align: center; line-height: 1.25;">Form 20-F&#160;<font style="font-family: 'Segoe UI Symbol', sans-serif;">&#9746;</font>&#160;&#160;&#160;&#160;&#160; Form 40-F&#160;<font style="font-family: 'Segoe UI Symbol', sans-serif;">&#9744;</font>&#160;</div>
      <div style="line-height: 1.25;"><br style="line-height: 1.25;">
      </div>
      <div style="line-height: 1.25;">This first two paragraphs of the press release attached as Exhibit 99.1 to this Report on Form 6-K is incorporated by reference into the
        Company&#8217;s Registration Statement on Form S-8 (Registration No. 333-257968 and 333-265902) and Form F-3 (File No. 333-259318), to be a part thereof from the date on which this report is submitted, to the extent not superseded by documents or reports
        subsequently filed or furnished.</div>
      <div style="line-height: 1.25;"><br style="line-height: 1.25;">
      </div>
      <div style="clear: both; margin-top: 10pt; margin-bottom: 10pt;" class="BRPFPageBreakArea">
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      <div style="line-height: 1.25">&#160;</div>
      <div style="line-height: 1.25;">On May 18, 2023, PainReform Ltd. issued a press release entitled &#8220;PainReform Announces Positive Pharmacokinetic (PK) Data in First Part
        of Phase 3 Clinical Trial of PRF-110 in Patients Undergoing Bunionectomy Surgery&#8221;. A copy of the press release is attached hereto as Exhibit 99.1 and incorporated herein by reference.</div>
      <div style="line-height: 1.25">&#160;</div>
      <div style="text-align: center; line-height: 1.25;">Exhibit Index</div>
      <div style="line-height: 1.25">&#160;</div>
      <table cellspacing="0" cellpadding="0" id="z37c792e68f654824bfd1f0e418580f28" style="font-family: 'Times New Roman', Times, serif; font-size: 10pt; width: 100%; text-align: left; color: #000000;">

          <tr>
            <td style="width: 11.51%; vertical-align: bottom; border-bottom: #000000 2px solid;">
              <div style="text-align: center; line-height: 1.25; font-weight: bold;">Exhibit No.</div>
            </td>
            <td style="width: 1.23%; vertical-align: bottom;"><br>
            </td>
            <td style="width: 87.26%; vertical-align: bottom; border-bottom: #000000 2px solid;">
              <div style="text-align: center; line-height: 1.25; font-weight: bold;">Description</div>
            </td>
          </tr>
          <tr>
            <td style="width: 11.51%; vertical-align: bottom;">
              <div style="text-align: center; line-height: 1.25;"><a href="exhibit_99-1.htm">99.1</a></div>
            </td>
            <td style="width: 1.23%; vertical-align: top;"><a href="exhibit_99-1.htm"><br>
              </a></td>
            <td style="width: 87.26%; vertical-align: bottom;">
              <div style="text-align: justify; line-height: 1.25;"><a href="exhibit_99-1.htm">Press Release dated
                  May 18, 2023</a></div>
            </td>
          </tr>

      </table>
      <div style="line-height: 1.25">&#160;</div>
      <div style="clear: both; margin-top: 10pt; margin-bottom: 10pt;" class="BRPFPageBreakArea">
        <div style="text-align: center;" class="BRPFPageNumberArea"><font style="font-weight: normal; font-style: normal;" class="BRPFPageNumber">2</font></div>
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      <div style="text-align: center; line-height: 1.25;"><font style="font-weight: bold;">SIGNATURES</font>&#160;</div>
      <div style="line-height: 1.25">&#160;</div>
      <div style="text-align: justify; line-height: 1.25;">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.</div>
      <div style="line-height: 1.25">&#160;</div>
      <table cellspacing="0" cellpadding="0" id="zf15eefd30c1d4956950286f5b2736d73" style="font-family: 'Times New Roman', Times, serif; font-size: 10pt; width: 100%; text-align: left; color: #000000;">

          <tr>
            <td style="width: 50%; vertical-align: top;">
              <div style="line-height: 1.25;">Date: May 18, 2023</div>
            </td>
            <td style="vertical-align: middle;" colspan="2">
              <div style="line-height: 1.25; font-weight: bold;">PAINREFORM LTD.</div>
            </td>
            <td style="width: 20%; vertical-align: middle;" colspan="1">&#160;</td>
          </tr>
          <tr>
            <td style="width: 50%; vertical-align: top;">
              <div style="line-height: 1.25;">&#160;</div>
            </td>
            <td style="vertical-align: middle;" colspan="2">
              <div style="line-height: 1.25;">&#160;</div>
            </td>
            <td style="width: 20%; vertical-align: middle;" colspan="1">&#160;</td>
          </tr>
          <tr>
            <td style="width: 50%; vertical-align: top; padding-bottom: 2px;">
              <div style="line-height: 1.25;">&#160;</div>
            </td>
            <td style="width: 3%; vertical-align: middle; padding-bottom: 2px;">
              <div style="line-height: 1.25;">By:</div>
            </td>
            <td style="width: 27%; vertical-align: top; border-bottom: 2px solid rgb(0, 0, 0);">
              <div style="line-height: 1.25;">/s/ Ilan Hadar</div>
            </td>
            <td style="width: 20%; vertical-align: top; padding-bottom: 2px;" colspan="1">&#160;</td>
          </tr>
          <tr>
            <td style="width: 50%; vertical-align: top;">
              <div style="line-height: 1.25;">&#160;</div>
            </td>
            <td style="width: 3%; vertical-align: middle;">
              <div style="line-height: 1.25;">&#160;</div>
            </td>
            <td style="width: 27%; vertical-align: top;">
              <div style="line-height: 1.25;">Ilan Hadar</div>
            </td>
            <td style="width: 20%; vertical-align: top;" colspan="1">&#160;</td>
          </tr>
          <tr>
            <td style="width: 50%; vertical-align: top;">
              <div style="line-height: 1.25;">&#160;</div>
            </td>
            <td style="width: 3%; vertical-align: middle;">
              <div style="line-height: 1.25;">&#160;</div>
            </td>
            <td style="width: 27%; vertical-align: top;">
              <div style="line-height: 1.25;">Chief Executive Officer</div>
            </td>
            <td style="width: 20%; vertical-align: top;" colspan="1">&#160;</td>
          </tr>

      </table>
      <div style="line-height: 1.25">&#160;</div>
    </div>
  </div>
  <div style="text-align: center;" class="BRPFPageNumberArea"><font style="font-weight: normal; font-style: normal;" class="BRPFPageNumber">3</font>
    <hr align="center" style="border: none; border-bottom: 4px solid black; border-top: 1px solid black; height: 10px; color: #ffffff; background-color: #ffffff; margin-left: auto; margin-right: auto;"></div>
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</DOCUMENT>
<DOCUMENT>
<TYPE>EX-99.1
<SEQUENCE>2
<FILENAME>exhibit_99-1.htm
<DESCRIPTION>EXHIBIT 99.1
<TEXT>
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<body bgcolor="#ffffff" style="font-family: 'Times New Roman', Times, serif; font-size: 10pt; text-align: left; color: #000000;">
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    <hr align="center" style="border: none; border-bottom: 1px solid black; border-top: 4px solid black; height: 10px; color: #ffffff; background-color: #ffffff; text-align: center; margin-left: auto; margin-right: auto;">
    <div style="text-align: right;"> <u><font style="font-weight: bold;">Exhibit 99.1</font></u><br>
    </div>
    <div style="text-align: center;"> <img src="image00002.jpg"></div>
    <div>
      <div class="BRPFPageHeader">
        <div style="line-height: 1.25;"><br style="line-height: 1.25;">
        </div>
      </div>
      <div style="text-align: center; line-height: 1.25; font-family: 'Times New Roman',Times,serif; font-size: 12pt; font-weight: bold; background-color: rgb(255, 255, 255); color: rgb(0, 0, 0); font-style: normal; font-variant: normal; text-transform: none;">PainReform Announces Positive Pharmacokinetic (PK) Data in First Part of Phase 3 </div>
      <div style="text-align: center; line-height: 1.25; font-family: 'Times New Roman',Times,serif; font-size: 12pt; font-weight: bold; background-color: rgb(255, 255, 255); color: rgb(0, 0, 0); font-style: normal; font-variant: normal; text-transform: none;">Clinical Trial of PRF-110 in Patients Undergoing Bunionectomy Surgery</div>
      <div style="line-height: 1.25;"><br style="line-height: 1.25;">
      </div>
      <div style="text-align: center; line-height: 1.25; font-style: italic;">Reports excellent compliance with FDA safety requirements in the first part<br>
        of its Phase III with 15 patients</div>
      <div style="line-height: 1.25;"><br style="line-height: 1.25;">
      </div>
      <div style="text-align: justify; line-height: 1.25;"><font style="font-weight: bold;">Tel Aviv, Israel &#8211; May 18, 2023 &#8211; </font><u>PainReform Ltd.</u> (Nasdaq: PRFX) ("<font style="font-weight: bold;">PainReform</font>" or the
        "Company"), a clinical-stage specialty pharmaceutical company focused on the reformulation of established therapeutics, today announced positive pharmacokinetic (PK) data in the first part of its two-part Phase 3 clinical trial of PRF-110, which
        enrolled 15 bunionectomy patients at two clinical sites in Texas.</div>
      <div style="line-height: 1.25;"><br style="line-height: 1.25;">
      </div>
      <div style="text-align: justify; line-height: 1.25;">During Part I of this study, blood samples were collected at specified time points post-surgery, through 72 hours, to determine
        maximum plasma ropivacaine concentrations (Cmax).&#160; Cmax value among all of the 15 patients, was approximately 10% of the safety window set by FDA.</div>
      <div style="line-height: 1.25;"><br style="line-height: 1.25;">
      </div>
      <div style="text-align: justify; line-height: 1.25;">Ilan Hadar, Chief Executive Officer of Pain Reform, stated, "We are encouraged by the PK results which demonstrated that PRF-110
        showed a favorable pharmacokinetic profile, a critical step towards regulatory approval. The successful completion of the safety and PK determination allows us to proceed directly into the second part of our Phase&#160;3 trial.&#8221;</div>
      <div style="line-height: 1.25;"><br style="line-height: 1.25;">
      </div>
      <div style="text-align: justify; line-height: 1.25;">The Phase 3 trial is a randomized, double-blind, placebo- and active-controlled, multicenter study to evaluate the analgesic efficacy
        and safety of intra-operative administration of PRF-110 following unilateral bunionectomy. PRF-110 is an oil-based, viscous, clear solution that is deposited directly into the surgical wound bed before closure to provide localized and extended
        postoperative analgesia.</div>
      <div style="line-height: 1.25;"><br style="line-height: 1.25;">
      </div>
      <div style="text-align: justify; line-height: 1.25;">The forthcoming second part of the trial will be a double-blind study, in which the Company plans to randomize approximately 400
        patients at seven clinical sites in the U.S. PRF-110 will be administered intra-operatively, using the experience gained in the study&#8217;s first part, and will be divided into three cohorts, PRF-110, ropivacaine, and placebo. As previously reported,
        PRF-110 provided pain reduction for up to 72 hours post-operatively in the Company&#8217;s prior Phase 2 proof-of-concept clinical study in herniorrhaphy (hernia repair). PRF-110 is a highly uniform solution, resulting in consistent sustained and
        extended release of the analgesic. Ropivacaine, the active drug used in PRF-110, is a safe, well-tolerated, and well-characterized local anesthetic. The other components that make up the remainder of the PRF-110 formulation have been designated by
        the FDA as Generally Recognized as Safe (GRAS), by the FDA, mitigating many potential safety issues.</div>
      <div style="line-height: 1.25">&#160;</div>
      <div style="text-align: justify; line-height: 1.25; font-weight: bold;">About PainReform</div>
      <div style="line-height: 1.25">&#160;</div>
      <div style="text-align: justify; line-height: 1.25;">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 postoperative 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 postoperative 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.</div>
      <div style="line-height: 1.25">&#160;</div>
      <div style="clear: both; margin-top: 10pt; margin-bottom: 10pt;" class="BRPFPageBreakArea">
        <div style="page-break-after: always;" class="BRPFPageBreak">
          <hr noshade="noshade" style="border-width: 0px; clear: both; margin: 4px 0px; width: 100%; height: 2px; color: #000000; background-color: #000000;"></div>
      </div>
      <div style="text-align: justify; line-height: 1.25; font-weight: bold;">Notice Regarding Forward-Looking Statements</div>
      <div style="text-align: justify; line-height: 1.25; font-style: italic;">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 ability to continue as a going concern, our history of 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;&#160; 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; 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.</div>
      <div style="line-height: 1.25;"><br style="line-height: 1.25;">
      </div>
      <div style="text-align: justify; line-height: 1.25; font-weight: bold;">Contact:</div>
      <div style="line-height: 1.25;"><br style="line-height: 1.25;">
      </div>
      <div style="text-align: justify; line-height: 1.25;">Crescendo Communications, LLC</div>
      <div style="text-align: justify; line-height: 1.25;">Tel: 212-671-1021</div>
      <div style="text-align: justify; line-height: 1.25;">Email: <u>prfx@crescendo-ir.com</u></div>
      <div style="line-height: 1.25;"><br style="line-height: 1.25;">
      </div>
      <div style="text-align: justify; line-height: 1.25;">Ilan Hadar</div>
      <div style="text-align: justify; line-height: 1.25;">Chief Executive Officer</div>
      <div style="text-align: justify; line-height: 1.25;">PainReform Ltd.</div>
      <div style="text-align: justify; line-height: 1.25;">Tel: +972-54-5331725</div>
      <div style="text-align: justify; line-height: 1.25;">Email: <u>ihadar@painreform.com</u></div>
      <div style="line-height: 1.25;"><br style="line-height: 1.25;">
      </div>
      <div style="line-height: 1.25;">
        <hr align="center" style="border: none; border-bottom: 4px solid black; border-top: 1px solid black; height: 10px; color: #ffffff; background-color: #ffffff; text-align: center; margin-left: auto; margin-right: auto;"></div>
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end
</TEXT>
</DOCUMENT>
</SEC-DOCUMENT>
