<SEC-DOCUMENT>0001104659-21-114969.txt : 20210913
<SEC-HEADER>0001104659-21-114969.hdr.sgml : 20210913
<ACCEPTANCE-DATETIME>20210913121155
ACCESSION NUMBER:		0001104659-21-114969
CONFORMED SUBMISSION TYPE:	8-K
PUBLIC DOCUMENT COUNT:		3
CONFORMED PERIOD OF REPORT:	20210909
ITEM INFORMATION:		Regulation FD Disclosure
ITEM INFORMATION:		Financial Statements and Exhibits
FILED AS OF DATE:		20210913
DATE AS OF CHANGE:		20210913

FILER:

	COMPANY DATA:	
		COMPANY CONFORMED NAME:			Rezolute, Inc.
		CENTRAL INDEX KEY:			0001509261
		STANDARD INDUSTRIAL CLASSIFICATION:	PHARMACEUTICAL PREPARATIONS [2834]
		IRS NUMBER:				273440894
		STATE OF INCORPORATION:			DE
		FISCAL YEAR END:			0630

	FILING VALUES:
		FORM TYPE:		8-K
		SEC ACT:		1934 Act
		SEC FILE NUMBER:	001-39683
		FILM NUMBER:		211249128

	BUSINESS ADDRESS:	
		STREET 1:		201 REDWOOD SHORES PARKWAY, SUITE 315
		CITY:			REDWOOD CITY
		STATE:			CA
		ZIP:			94065
		BUSINESS PHONE:		650-847-1919

	MAIL ADDRESS:	
		STREET 1:		201 REDWOOD SHORES PARKWAY, SUITE 315
		CITY:			REDWOOD CITY
		STATE:			CA
		ZIP:			94065

	FORMER COMPANY:	
		FORMER CONFORMED NAME:	AntriaBio, Inc.
		DATE OF NAME CHANGE:	20130114

	FORMER COMPANY:	
		FORMER CONFORMED NAME:	FITS MY STYLE INC
		DATE OF NAME CHANGE:	20110104
</SEC-HEADER>
<DOCUMENT>
<TYPE>8-K
<SEQUENCE>1
<FILENAME>tm2127422d1_8k.htm
<DESCRIPTION>FORM 8-K
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<P STYLE="margin: 0">&nbsp;</P>

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<P STYLE="font: 18pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: center"><B>UNITED STATES</B></P>

<P STYLE="font: 18pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: center"><B>SECURITIES AND EXCHANGE COMMISSION</B></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: center"><B>WASHINGTON, DC 20549</B>&nbsp;</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: center">&nbsp;</P>



<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: center"></P>

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<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: center">&nbsp;</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: center"><FONT STYLE="font-size: 18pt"><B>FORM 8-K</B></FONT><FONT STYLE="font-size: 10pt">&nbsp;</FONT></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: center">&nbsp;</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: center"></P>

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<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: center"><B>CURRENT REPORT</B></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: center"><B>Pursuant to Section&nbsp;13 or 15(d) of the</B></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: center"><B>Securities Exchange Act of 1934</B></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: center">&nbsp;</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: center"><B>Date of report (Date of earliest event reported):&nbsp;&nbsp;&nbsp;&nbsp;September 13, 2021</B>&nbsp;<B>(September 9, 2021)</B></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: center">&nbsp;</P>

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<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: center">&nbsp;</P>



<P STYLE="font: 14pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: center"><B><U>REZOLUTE, INC.</U></B></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: center"><B>(Exact Name of Registrant as Specified in Charter)</B><FONT STYLE="font-size: 10pt">&nbsp;</FONT></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: center">&nbsp;</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: center"></P>

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<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: center">&nbsp;</P>



<TABLE CELLSPACING="0" CELLPADDING="0" STYLE="font: 10pt Times New Roman, Times, Serif; width: 100%; border-collapse: collapse">
  <TR>
    <TD STYLE="vertical-align: top; text-align: center; width: 38%"><FONT STYLE="font-family: Times New Roman, Times, Serif"><B><U>Nevada</U></B></FONT></TD>
    <TD STYLE="vertical-align: bottom; width: 1%">&nbsp;</TD>
    <TD STYLE="vertical-align: top; text-align: center; width: 26%"><FONT STYLE="font-family: Times New Roman, Times, Serif"><B><U>000-54495</U></B></FONT></TD>
    <TD STYLE="vertical-align: bottom; width: 1%">&nbsp;</TD>
    <TD STYLE="vertical-align: top; text-align: center; width: 34%"><FONT STYLE="font-family: Times New Roman, Times, Serif"><B><U>27-3440894</U></B></FONT></TD></TR>
  <TR>
    <TD STYLE="vertical-align: top">
    <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: center"><B>(State or Other Jurisdiction</B></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: center"><B>of Incorporation)</B></P>

</TD>
    <TD STYLE="vertical-align: bottom">&nbsp;</TD>
    <TD STYLE="vertical-align: top">
    <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: center"><B>(Commission</B></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: center"><B>File Number)</B></P>

</TD>
    <TD STYLE="vertical-align: bottom">&nbsp;</TD>
    <TD STYLE="vertical-align: top">
    <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: center"><B>(I.R.S. Employer</B></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: center"><B>Identification No.)</B></P>

</TD></TR>
  </TABLE>
<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: center">&nbsp;</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: center"><B><U>201 Redwood Shores Pkwy, Suite 315, Redwood
City, CA 94065</U></B></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: center"><B>(Address of Principal Executive Offices, and
Zip Code)</B></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: center">&nbsp;</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: center"><B><U>650-206-4507</U></B></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: center"><B>Registrant&rsquo;s Telephone Number, Including
Area Code</B></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: center">&nbsp;</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: center"><B><U>Not Applicable</U></B></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: center"><B>(Former Name or Former Address, if Changed Since
Last Report)</B>&nbsp;</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: center">&nbsp;</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0">Check the appropriate box below if the Form 8-K filing is intended
to simultaneously satisfy the filing obligation of the registrant under any of the following provisions (<I>see</I> General Instruction
A.2. below):</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0">&nbsp;</P>

<TABLE CELLSPACING="0" CELLPADDING="0" STYLE="width: 100%; font: 10pt Times New Roman, Times, Serif; border-collapse: collapse">
  <TR>
    <TD STYLE="width: 4%">&nbsp;</TD>
    <TD STYLE="vertical-align: top; width: 4%"><FONT STYLE="font-family: Wingdings; font-size: 10pt"><FONT STYLE="font-family: Wingdings">&#168;</FONT></FONT></TD>
    <TD STYLE="vertical-align: top; width: 92%"><FONT STYLE="font-family: Times New Roman, Times, Serif">Written communication pursuant to Rule 425 under the Securities Act (17 CFR 230.425)</FONT></TD></TR>
  </TABLE>
<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0">&nbsp;</P>

<TABLE CELLSPACING="0" CELLPADDING="0" STYLE="width: 100%; font: 10pt Times New Roman, Times, Serif; border-collapse: collapse">
  <TR>
    <TD STYLE="width: 4%">&nbsp;</TD>
    <TD STYLE="vertical-align: top; width: 4%"><FONT STYLE="font-family: Wingdings; font-size: 10pt"><FONT STYLE="font-family: Wingdings">&#168;</FONT></FONT></TD>
    <TD STYLE="vertical-align: top; width: 92%"><FONT STYLE="font-family: Times New Roman, Times, Serif">Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)</FONT></TD></TR>
  </TABLE>
<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0">&nbsp;</P>

<TABLE CELLSPACING="0" CELLPADDING="0" STYLE="width: 100%; font: 10pt Times New Roman, Times, Serif; border-collapse: collapse">
  <TR>
    <TD STYLE="width: 4%">&nbsp;</TD>
    <TD STYLE="vertical-align: top; width: 4%"><FONT STYLE="font-family: Wingdings; font-size: 10pt"><FONT STYLE="font-family: Wingdings">&#168;</FONT></FONT></TD>
    <TD STYLE="vertical-align: top; width: 92%"><FONT STYLE="font-family: Times New Roman, Times, Serif">Pre-commencement communication pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))</FONT></TD></TR>
  </TABLE>
<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0">&nbsp;</P>

<TABLE CELLSPACING="0" CELLPADDING="0" STYLE="font: 10pt Times New Roman, Times, Serif; width: 100%; border-collapse: collapse">
<TR>
<TD STYLE="width: 4%">&nbsp;</TD>
<TD STYLE="vertical-align: top; width: 4%"><FONT STYLE="font: 10pt Wingdings"><FONT STYLE="font-family: Wingdings">&#168;</FONT></FONT></TD>
<TD STYLE="vertical-align: top; width: 92%">Pre-commencement communication pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c)) &nbsp; &nbsp; &nbsp;</TD></TR>
</TABLE>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">&nbsp;</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0">Securities registered pursuant to Section 12(b) of the Act:</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0">&nbsp;</P>

<TABLE CELLSPACING="0" CELLPADDING="0" STYLE="font: 10pt Times New Roman, Times, Serif; width: 100%; border-collapse: collapse">
  <TR STYLE="vertical-align: top">
    <TD STYLE="width: 31%; border: Black 1pt solid; padding-right: 5.4pt; padding-bottom: 2.2pt; padding-left: 5.4pt; text-align: center"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">Title of each class</FONT></TD>
    <TD STYLE="width: 27%; border-top: Black 1pt solid; border-right: Black 1pt solid; border-bottom: Black 1pt solid; padding-right: 5.4pt; padding-bottom: 2.2pt; padding-left: 5.4pt; text-align: center"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">Trading Symbol(s)</FONT></TD>
    <TD STYLE="width: 42%; border-top: Black 1pt solid; border-right: Black 1pt solid; border-bottom: Black 1pt solid; padding-right: 5.4pt; padding-bottom: 2.2pt; padding-left: 5.4pt; text-align: center"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">Name of each exchange on which registered</FONT></TD></TR>
  <TR STYLE="vertical-align: top">
    <TD STYLE="border-right: Black 1pt solid; border-bottom: Black 1pt solid; border-left: Black 1pt solid; padding-right: 5.4pt; padding-bottom: 2.2pt; padding-left: 5.4pt; text-align: center"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt"><B>Common Stock, par value $0.001 per share</B></FONT></TD>
    <TD STYLE="border-right: Black 1pt solid; border-bottom: Black 1pt solid; padding-right: 5.4pt; padding-bottom: 2.2pt; padding-left: 5.4pt; text-align: center"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt"><B>RZLT</B></FONT></TD>
    <TD STYLE="border-right: Black 1pt solid; border-bottom: Black 1pt solid; padding-right: 5.4pt; padding-bottom: 2.2pt; padding-left: 5.4pt; text-align: center"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt"><B>Nasdaq Capital Market</B></FONT></TD></TR>
  </TABLE>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0">&nbsp;</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; background-color: white">Indicate by check mark whether the registrant
is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (17 CFR &sect;230.405 of this chapter) or Rule 12b-2
of the Securities Exchange Act of 1934 (17 CFR &sect;240.12b-2 of this chapter).</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: right; background-color: white">&nbsp;</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: right; background-color: white">Emerging growth company
<FONT STYLE="font-family: Wingdings">&#168;</FONT></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: right; background-color: white">&nbsp;</P>

<P STYLE="margin: 0pt 0; font: 10pt Times New Roman, Times, Serif">If an emerging growth company, indicate by check mark if the registrant
has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant
to Section 13(a) of the Exchange Act. <FONT STYLE="font-family: Wingdings">&#168;</FONT></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">&nbsp;</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify"></P>

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<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">&nbsp;</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify"></P>

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<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">&nbsp;</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify"><B>Item 7.01. Regulation FD Disclosure.</B></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify"><B>&nbsp;</B></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">On September 9, 2021, Rezolute, Inc. (&ldquo;Rezolute&rdquo;)
announced the initiation of dosing in the second cohort of its Phase 2b Trial of RZ358 for Congenital Hyperinsulinism.</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">&nbsp;</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; background-color: white"><B>Item 9.01.&nbsp; Financial
Statements and Exhibits</B></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; background-color: white">&nbsp;</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; background-color: white">(d) Exhibits.</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">&nbsp;</P>

<TABLE CELLPADDING="0" CELLSPACING="0" BORDER="0" STYLE="width: 100%; margin-top: 0pt; margin-bottom: 0pt; font: 10pt Times New Roman, Times, Serif">
<TR STYLE="vertical-align: top">
  <TD STYLE="border-bottom: Black 1pt solid; font: 10pt Times New Roman, Times, Serif; text-align: justify; width: 10%"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">Exhibit </FONT></TD>
    <TD STYLE="font: 10pt Times New Roman, Times, Serif; width: 2%"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">&nbsp;</FONT></TD>
  <TD STYLE="border-bottom: Black 1pt solid; font: 10pt Times New Roman, Times, Serif; text-align: justify; width: 88%"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">Description</FONT></TD></TR>

<TR STYLE="font: 10pt Times New Roman, Times, Serif; vertical-align: top">
<TD STYLE="font: 10pt Times New Roman, Times, Serif"><A HREF="tm2127422d1_ex99-1.htm" STYLE="-sec-extract: exhibit"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">99.1</FONT></A></TD>
    <TD STYLE="font: 10pt Times New Roman, Times, Serif"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">&nbsp;</FONT></TD><TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: justify"><A HREF="tm2127422d1_ex99-1.htm" STYLE="-sec-extract: exhibit"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">Press release
                   dated September 9, 2021</FONT></A></TD></TR></TABLE>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: center"><B>&nbsp;</B></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: center"></P>

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<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: center">&nbsp;</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: center"><B>SIGNATURES</B></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: center">&nbsp;</P>

<P STYLE="text-align: justify; font: 10pt Times New Roman, Times, Serif; margin: 0pt 0">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 hereunto duly authorized.</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0">&nbsp;</P>

<TABLE CELLSPACING="0" CELLPADDING="0" STYLE="font: 10pt Times New Roman, Times, Serif; width: 100%; border-collapse: collapse">
<TR STYLE="vertical-align: top">
<TD>&nbsp;</TD>
<TD COLSPAN="2"><FONT STYLE="font-family: Times New Roman, Times, Serif"><B>REZOLUTE, INC.</B></FONT></TD></TR>
<TR>
<TD STYLE="width: 50%">&nbsp;</TD>
<TD STYLE="width: 3%">&nbsp;</TD>
<TD STYLE="width: 47%">&nbsp;</TD></TR>
<TR>
<TD>&nbsp;</TD>
<TD>&nbsp;</TD>
<TD>&nbsp;</TD></TR>
<TR STYLE="vertical-align: top">
<TD><FONT STYLE="font-family: Times New Roman, Times, Serif">DATE:&nbsp;&nbsp;September 13, 2021</FONT></TD>
<TD><FONT STYLE="font-family: Times New Roman, Times, Serif">By:</FONT></TD>
<TD STYLE="border-bottom: Black 1pt solid"><FONT STYLE="font-family: Times New Roman, Times, Serif"><I>/s/ Nevan Elam</I></FONT></TD></TR>
<TR STYLE="vertical-align: top">
<TD>&nbsp;</TD>
<TD>&nbsp;</TD>
<TD>Nevan Elam</TD></TR>
<TR STYLE="vertical-align: top">
<TD>&nbsp;</TD>
<TD>&nbsp;</TD>
<TD>Chief Executive Officer&nbsp;</TD></TR>
</TABLE>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: center">&nbsp;</P>



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<DOCUMENT>
<TYPE>EX-99.1
<SEQUENCE>2
<FILENAME>tm2127422d1_ex99-1.htm
<DESCRIPTION>EXHIBIT 99.1
<TEXT>
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<P STYLE="margin: 0">&nbsp;</P>

<P STYLE="text-align: right; margin: 0"><B>Exhibit 99.1&nbsp;</B></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: center">&nbsp;</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: left"><IMG SRC="tm2127422d1_ex99-1img01.jpg" ALT="">&nbsp;</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: center"><B>&nbsp;</B></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: center"><B>Rezolute Announces Initiation of Dosing in the
Second Cohort of its Phase 2b Trial of RZ358 for </B></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: center"><FONT STYLE="background-color: white"><B>Congenital
Hyperinsulinism </B></FONT></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: center"><B>&nbsp;</B></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: center"><B><I>Tracking to Announce Top line data in Q1
2022</I></B></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0"><B>&nbsp;</B></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">REDWOOD CITY, CA, September 9, 2021 (GLOBE NEWSWIRE)
 &ndash; <B>Rezolute, Inc.</B> (Nasdaq: RZLT), <FONT STYLE="background-color: white">a clinical-stage biopharmaceutical company developing
transformative therapies for metabolic diseases associated with chronic glucose imbalance, </FONT>today announced that it has begun dosing
patients in the second cohort of its Phase 2b clinical trial of RZ358 (RIZE). <FONT STYLE="background-color: white">RZ358 is a monoclonal
antibody targeting the treatment of hypoglycemia caused by excessive insulin levels and is currently in clinical development for congenital
hyperinsulinism (HI), a rare pediatric endocrine disorder. </FONT></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">&nbsp;</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">Rezolute reported that a dose escalation review
committee, comprised of HI expert investigators, voted to approve dose escalation and initiation of cohort 2 (6 mg/kg), based on their
interim review of safety data from Cohort 1 (3 mg/kg). Following completion of the second cohort, the company plans to initiate a third
and likely final cohort at 9 mg/kg.</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">&nbsp;</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify"><FONT STYLE="background-color: white">&ldquo;We
are making great strides with the RIZE study and based on our recent clinical trial activity, we are tracking toward the original timeline
we laid out prior to the COVID-19 pandemic. In that regard, we are expecting to substantially complete enrollment by the end of 2021 and
have top-line data in Q1 of 2022,&rdquo; said Brian Roberts, MD, Senior Vice President and Head of Clinical Development at Rezolute. &ldquo;We
will continue to monitor the evolution of the pandemic, including the impact of the Delta variant, which could alter our ability to screen
and enroll patients in a timely fashion.&rdquo;</FONT></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">&nbsp;</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">Rezolute also announced <FONT STYLE="background-color: white">the
addition of Adrian Vella, MD, Professor of Medicine in the Endocrinology Division at the Mayo Clinic College of Medicine, to the Company&rsquo;s
Scientific Advisory Board. Dr. Vella is a leading expert in hypoglycemic disorders and will provide guidance on the development of RZ358.
</FONT></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; color: #202124">&nbsp;</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify"><FONT STYLE="color: #202124; background-color: white">Dr.
Roberts noted, </FONT><FONT STYLE="background-color: white">&ldquo;We are pleased to welcome Dr. Vella to our Scientific Advisory Board.
Given his background and knowledge of RZ358, he will be extremely valuable to Rezolute as we advance the development of RZ358 for HI and
evaluate the possibility of expanding into other related and applicable indications.&rdquo; </FONT></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">&nbsp;</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify"><FONT STYLE="background-color: white">Dr. Vella
is a Professor of Medicine in the Mayo Clinic College of Medicine and </FONT>has published over 160 peer reviewed articles related to
endocrinology, metabolic disorders, and diabetes. He is regularly the lead author or editor on evidence-based reviews of hyperinsulinism
and hypoglycemia<FONT STYLE="color: #202124; background-color: white">.</FONT></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify"><B>&nbsp;</B></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify"></P>

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<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify"><B>&nbsp;</B></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify"><B>About RIZE (RZ358-606)</B></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">&nbsp;</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">The open-label, repeat-dose Phase 2b study is
designed to assess the safety and tolerability of intravenously administered RZ358 in patients with congenital hyperinsulinism inadequately
controlled on existing therapies. The Company intends to enroll up to four sequential dosing cohorts, each with up to six to eight patients,
starting at a dose of 3 mg/kg and increasing to as high as 9 mg/kg in the final cohort, as needed and tolerated. RZ358 will be administered
bi-weekly for a total treatment duration of 8 weeks. The study is being conducted at leading HI centers by Rezolute and its global study
partners.</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify"><B>&nbsp;</B></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify"><B>About RZ358</B></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">&nbsp;</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">RZ358 is an intravenously administered human monoclonal
antibody that binds to a unique site (allosteric) on the insulin receptor throughout the body, such as in the liver, fat, and muscle.
The antibody modifies insulin's binding and signaling to maintain glucose levels in a normal range which counteracts the effects of elevated
insulin in the body. Therefore, the company believes that RZ358 is ideally suited as a potential therapy for conditions characterized
by excessive insulin levels, and it is being developed to treat the hyperinsulinism and low blood sugar characteristic of diseases such
as congenital HI. As RZ358 acts downstream from the beta cells, it has the potential to be universally effective at treating congenital
HI caused by any of the underlying genetic defects.</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; background-color: white">&nbsp;</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; background-color: white">RZ358 received Orphan
Drug Designation in the United States and European Union as well as Pediatric Rare Disease Designation in the US. Rezolute is currently
evaluating RZ358 in the RIZE trial, a Phase 2b clinical trial in patients with congenital hyperinsulinism.</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; background-color: white">&nbsp;</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; background-color: white"><B>About Rezolute, Inc.</B></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; background-color: white">&nbsp;</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; background-color: white"><FONT STYLE="background-color: white">Rezolute
is developing transformative therapies for metabolic diseases related to chronic glucose imbalance. The Company&rsquo;s lead clinical
asset, RZ358, is in Phase 2b development for treatment of congenital hyperinsulinism (HI), a rare pediatric endocrine disorder. The Company
is also developing RZ402, an orally available plasma kallikrein inhibitor, for the treatment of diabetic macular edema. For more information,
visit www.rezolutebio.com or follow us on Twitter.</FONT></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; background-color: white"><B>&nbsp;</B></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; background-color: white"><B>Forward-Looking Statements
</B></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; background-color: white">&nbsp;</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; background-color: white"><FONT STYLE="font-weight: normal">This
release, like many written and oral communications presented by Rezolute, Inc. and our authorized officers, may contain certain forward-looking
statements regarding our prospective performance and strategies within the meaning of Section 27A of the Securities Act and Section 21E
of the Securities Exchange Act of 1934, as amended. We intend such forward-looking statements to be covered by the safe harbor provisions
for forward-looking statements contained in the Private Securities Litigation Reform Act of 1995 and are including this statement for
purposes of said safe harbor provisions. Forward-looking statements, which are based on certain assumptions and describe future plans,
strategies, and expectations of the Company, are generally identified by use of words such as &quot;anticipate,&quot; &quot;believe,&quot;
 &quot;estimate,&quot; &quot;expect,&quot; &quot;intend,&quot; &quot;plan,&quot; &quot;project,&quot; &quot;seek,&quot; &quot;strive,&quot;
 &quot;try,&quot; or future or conditional verbs such as &quot;could,&quot; &quot;may,&quot; &quot;should,&quot; &quot;will,&quot; &quot;would,&quot;
or similar expressions. Our ability to predict results or the actual effects of our plans or strategies is inherently uncertain. Accordingly,
actual results may differ materially from anticipated results. Readers are cautioned not to place undue reliance on these forward-looking
statements, which speak only as of the date of this release. Except as required by applicable law or regulation, Rezolute undertakes no
obligation to update these forward-looking statements to reflect events or circumstances that occur after the date on which such statements
were made.</FONT></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; background-color: white"><B>&nbsp;</B></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; background-color: white"><B>Media and Investor Contact</B></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; background-color: white">Argot Partners</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; background-color: white"><U>rezolute@argotpartners.com</U></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; background-color: white">212-600-1902</P>



<P STYLE="margin: 0">&nbsp;</P>

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#0__9

end
</TEXT>
</DOCUMENT>
</SEC-DOCUMENT>
