<SEC-DOCUMENT>0000912282-18-000062.txt : 20180409
<SEC-HEADER>0000912282-18-000062.hdr.sgml : 20180409
<ACCEPTANCE-DATETIME>20180409141003
ACCESSION NUMBER:		0000912282-18-000062
CONFORMED SUBMISSION TYPE:	8-K
PUBLIC DOCUMENT COUNT:		3
CONFORMED PERIOD OF REPORT:	20180409
ITEM INFORMATION:		Regulation FD Disclosure
ITEM INFORMATION:		Financial Statements and Exhibits
FILED AS OF DATE:		20180409
DATE AS OF CHANGE:		20180409

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:	000-54495
		FILM NUMBER:		18745253

	BUSINESS ADDRESS:	
		STREET 1:		1450 INFINITE DRIVE
		CITY:			LOUISVILLE
		STATE:			CO
		ZIP:			80027
		BUSINESS PHONE:		650-847-1919

	MAIL ADDRESS:	
		STREET 1:		1450 INFINITE DRIVE
		CITY:			LOUISVILLE
		STATE:			CO
		ZIP:			80027

	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>
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<div style="FONT-SIZE: 10pt; FONT-FAMILY: 'Times New Roman', Times, serif; FONT-WEIGHT: bold; TEXT-ALIGN: center">UNITED STATES</div>

<div style="FONT-SIZE: 10pt; FONT-FAMILY: 'Times New Roman', Times, serif; FONT-WEIGHT: bold; TEXT-ALIGN: center">SECURITIES AND EXCHANGE COMMISSION</div>

<div style="FONT-SIZE: 10pt; FONT-FAMILY: 'Times New Roman', Times, serif; FONT-WEIGHT: bold; TEXT-ALIGN: center">WASHINGTON, D.C. 20549</div>

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<div style="FONT-SIZE: 10pt; FONT-FAMILY: 'Times New Roman', Times, serif; FONT-WEIGHT: bold; TEXT-ALIGN: center">FORM 8-K</div>

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<div style="FONT-SIZE: 10pt; FONT-FAMILY: 'Times New Roman', Times, serif; FONT-WEIGHT: bold; TEXT-ALIGN: center">CURRENT REPORT</div>

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<div style="FONT-SIZE: 10pt; FONT-FAMILY: 'Times New Roman', Times, serif; TEXT-ALIGN: center">Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934</div>

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<div style="FONT-SIZE: 10pt; FONT-FAMILY: 'Times New Roman', Times, serif; TEXT-ALIGN: center">Date of Report (Date of earliest event reported): April 9, 2018</div>

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<div style="FONT-SIZE: 10pt; FONT-FAMILY: 'Times New Roman', Times, serif; FONT-WEIGHT: bold; TEXT-ALIGN: center"><u>REZOLUTE, INC.</u></div>

<div style="FONT-SIZE: 10pt; FONT-FAMILY: 'Times New Roman', Times, serif; TEXT-ALIGN: center">(Name of registrant in its charter)</div>

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<div style="TEXT-ALIGN: center"><u>Delaware</u></div>
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<div style="TEXT-ALIGN: center"><u>000-54495</u></div>
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<div style="TEXT-ALIGN: center"><u>27-3440894</u></div>
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<div style="FONT-SIZE: 10pt; FONT-FAMILY: 'Times New Roman', Times, serif; TEXT-ALIGN: center">(State or jurisdiction</div>
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<div style="FONT-SIZE: 10pt; FONT-FAMILY: 'Times New Roman', Times, serif; TEXT-ALIGN: center">Number)</div>
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<div style="FONT-SIZE: 10pt; FONT-FAMILY: 'Times New Roman', Times, serif; TEXT-ALIGN: center">organization)&#160;</div>
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<div style="FONT-SIZE: 10pt; FONT-FAMILY: 'Times New Roman', Times, serif; TEXT-ALIGN: center">1450 Infinite Drive</div>

<div style="FONT-SIZE: 10pt; FONT-FAMILY: 'Times New Roman', Times, serif; TEXT-ALIGN: center">Louisville, CO 80027</div>

<div style="FONT-SIZE: 10pt; FONT-FAMILY: 'Times New Roman', Times, serif; TEXT-ALIGN: center">&#160;(Address of principal executive offices)</div>

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<div style="FONT-SIZE: 10pt; FONT-FAMILY: 'Times New Roman', Times, serif; TEXT-ALIGN: center">(303) 222-2128</div>

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<div style="FONT-SIZE: 10pt; FONT-FAMILY: 'Times New Roman', Times, serif; TEXT-ALIGN: center">&#160;(Former name or former address, if changed since last report)</div>

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<div style="FONT-SIZE: 10pt; FONT-FAMILY: 'Times New Roman', Times, serif; TEXT-ALIGN: left">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:</div>

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<div style="FONT-SIZE: 10pt; FONT-FAMILY: 'Times New Roman', Times, serif; TEXT-ALIGN: left">Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)</div>
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<div style="FONT-SIZE: 10pt; FONT-FAMILY: 'Times New Roman', Times, serif; TEXT-ALIGN: left">Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)</div>
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<div style="FONT-SIZE: 10pt; FONT-FAMILY: 'Times New Roman', Times, serif; TEXT-ALIGN: left">Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))</div>
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<div style="FONT-SIZE: 10pt; FONT-FAMILY: 'Times New Roman', Times, serif; TEXT-ALIGN: left">Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))</div>
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<div style="FONT-SIZE: 10pt; FONT-FAMILY: 'Times New Roman', Times, serif; FONT-WEIGHT: bold; TEXT-ALIGN: left">Item 7.01. Regulation FD Disclosure.</div>

<div style="FONT-SIZE: 10pt; FONT-FAMILY: 'Times New Roman', Times, serif; TEXT-ALIGN: left">&#160;</div>

<div style="FONT-SIZE: 10pt; FONT-FAMILY: 'Times New Roman', Times, serif; TEXT-ALIGN: left">On April 9, 2018, we issued the press release attached hereto as Exhibit 99.1.&#160;&#160;In accordance with General Instruction B.2 of Form 8-K, the information set forth herein and in the press release is deemed to be "furnished" and shall not be deemed to be "filed" for purposes of the Securities Exchange Act of 1934, as amended.&#160;&#160;The information set forth in Item 7.01 of this Current Report on Form 8-K shall not be deemed an admission as to the materiality of any information in this Current Report on Form 8-K that is required to be disclosed solely to satisfy the requirements of Regulation FD.</div>

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<div style="FONT-SIZE: 10pt; FONT-FAMILY: 'Times New Roman', Times, serif; FONT-WEIGHT: bold; TEXT-ALIGN: left">Item 9.01 Financial Statements and Exhibits</div>

<div style="FONT-SIZE: 10pt; FONT-FAMILY: 'Times New Roman', Times, serif; TEXT-ALIGN: left">&#160;</div>

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<div style="FONT-SIZE: 10pt; FONT-FAMILY: 'Times New Roman', Times, serif; FONT-WEIGHT: bold; TEXT-ALIGN: left">DESCRIPTION</div>
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<div style="FONT-SIZE: 10pt; FONT-FAMILY: 'Times New Roman', Times, serif; TEXT-ALIGN: left">99.1</div>
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<div style="FONT-SIZE: 10pt; FONT-FAMILY: 'Times New Roman', Times, serif; TEXT-ALIGN: left">Press Release of Rezolute, Inc. dated April 9, 2018 **</div>
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<div style="FONT-SIZE: 10pt; FONT-FAMILY: 'Times New Roman', Times, serif; TEXT-ALIGN: left">** The following exhibit relating to Item 7.01 is intended to be furnished to, not filed with, the SEC pursuant to Regulation FD.</div>

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<div style="FONT-SIZE: 10pt; FONT-FAMILY: 'Times New Roman', Times, serif; FONT-WEIGHT: bold; TEXT-ALIGN: center">SIGNATURES</div>

<div style="FONT-SIZE: 10pt; FONT-FAMILY: 'Times New Roman', Times, serif; TEXT-ALIGN: left">&#160;</div>

<div style="FONT-SIZE: 10pt; FONT-FAMILY: 'Times New Roman', Times, serif; TEXT-ALIGN: left">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.</div>

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<div style="FONT-SIZE: 10pt; FONT-FAMILY: 'Times New Roman', Times, serif; FONT-WEIGHT: bold; TEXT-ALIGN: left">REZOLUTE, INC.</div>
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<div style="FONT-SIZE: 10pt; FONT-FAMILY: 'Times New Roman', Times, serif; TEXT-ALIGN: left">DATE:&#160;&#160;April 9, 2018</div>
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<div style="FONT-SIZE: 10pt; FONT-FAMILY: 'Times New Roman', Times, serif; TEXT-ALIGN: left">By:</div>
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<div style="FONT-SIZE: 10pt; FONT-FAMILY: 'Times New Roman', Times, serif; TEXT-ALIGN: left">/s/ Morgan Fields&#160;&#160;&#160;&#160;&#160;&#160;&#160;&#160;&#160;</div>
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<div style="FONT-SIZE: 10pt; FONT-FAMILY: 'Times New Roman', Times, serif; TEXT-ALIGN: left">&#160;</div>
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<div style="FONT-SIZE: 10pt; FONT-FAMILY: 'Times New Roman', Times, serif; TEXT-ALIGN: left">Morgan Fields</div>

<div style="FONT-SIZE: 10pt; FONT-FAMILY: 'Times New Roman', Times, serif; TEXT-ALIGN: left">Chief Accounting Officer</div>
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<div style="FONT-SIZE: 10pt; FONT-FAMILY: 'Times New Roman', Times, serif; FONT-WEIGHT: bold; TEXT-ALIGN: center">EXHIBIT INDEX</div>

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<div style="FONT-SIZE: 10pt; FONT-FAMILY: 'Times New Roman', Times, serif; FONT-WEIGHT: bold; TEXT-ALIGN: left">DESCRIPTION</div>
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<div style="FONT-SIZE: 10pt; FONT-FAMILY: 'Times New Roman', Times, serif; TEXT-ALIGN: left">99.1</div>
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<div style="FONT-SIZE: 10pt; FONT-FAMILY: 'Times New Roman', Times, serif; TEXT-ALIGN: left">Press Release of Rezolute, Inc. dated April 9, 2018**</div>
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<div style="FONT-SIZE: 10pt; FONT-FAMILY: 'Times New Roman', Times, serif; TEXT-ALIGN: left">** The following exhibit relating to Item 7.01 is intended to be furnished to, not filed with, the SEC pursuant to Regulation FD.</div>

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<TYPE>EX-99.1
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<DESCRIPTION>PRESS RELEASE DATED APRIL 9, 2018
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<div style="FONT-WEIGHT: bold; TEXT-ALIGN: right">EXHIBIT 99.1</div>

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<div style="FONT-SIZE: 12pt; FONT-FAMILY: 'Times New Roman', Times, serif; FONT-WEIGHT: bold; TEXT-ALIGN: center"><font style="FONT-FAMILY: 'Times New Roman', Times, serif">Rezolute</font> Announces Appointment of Congenital Hyperinsulinism Therapeutic Area<br>
 Expert, Dr. Christine Ferrara, as Director of Clinical Development</div>

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<div style="FONT-SIZE: 10pt; MARGIN-BOTTOM: 12pt; FONT-FAMILY: 'Times New Roman', Times, serif; MARGIN-TOP: 12pt; TEXT-ALIGN: left"><font style="FONT-SIZE: 10pt; FONT-FAMILY: 'Times New Roman', Times, serif; FONT-WEIGHT: bold">LOUISVILLE, Colorado, April 9, 2018 &#8211; (GLOBE NEWSWIRE) &#8211; </font><font style="FONT-SIZE: 10pt; FONT-FAMILY: 'Times New Roman', Times, serif; FONT-VARIANT: normal; FONT-WEIGHT: bold; FONT-STYLE: normal"><u>Rezolute, Inc.</u></font><font style="FONT-SIZE: 10pt; FONT-FAMILY: 'Times New Roman', Times, serif; FONT-WEIGHT: bold"> ("Rezolute" or the "Company") (OTCQB: RZLT), </font><font style="FONT-SIZE: 10pt; FONT-FAMILY: 'Times New Roman', Times, serif">a </font><font style="FONT-SIZE: 10pt; FONT-FAMILY: 'Times New Roman', Times, serif; BACKGROUND-COLOR: #ffffff">clinical stage biopharmaceutical company specializing in the development of innovative drug therapies for metabolic and orphan diseases, </font><font style="FONT-SIZE: 10pt; FONT-FAMILY: 'Times New Roman', Times, serif">today that </font>Christine Ferrara, M.D., Ph.D., has joined the Company as Director of Clinical Development. In addition to supporting clinical development of the Company's pipeline generally, Dr. Ferrara will have primary responsibility for the clinical development program of <font style="FONT-SIZE: 10pt; FONT-FAMILY: 'Times New Roman', Times, serif; FONT-VARIANT: normal; FONT-WEIGHT: normal; FONT-STYLE: normal"><u>RZ358</u></font> for Congenital Hyperinsulinemia (CHI), a life-threatening ultra-orphan disease with a substantial unmet need for safer and more effective therapies. Dr. Ferrara joins Rezolute as the Company prepares to initiate a Phase 2b study of RZ358.</div>

<div style="FONT-SIZE: 10pt; MARGIN-BOTTOM: 12pt; FONT-FAMILY: 'Times New Roman', Times, serif; MARGIN-TOP: 12pt; TEXT-ALIGN: left">Dr. Ferrara is Assistant Professor of Pediatrics at University of California, San Francisco (UCSF) where she also serves as head of the regional treatment center for patients with CHI. She brings to Rezolute a wealth of experience as a Principal Investigator on industry and government-sponsored clinical trials. Dr. Ferrara completed her Pediatrics Residency and Endocrinology Fellowship at Children's Hospital of Philadelphia (CHOP), an internationally recognized referral center for CHI patients, under the thought leadership and training of Drs. Diva D. De Le&#243;n-Crutchlow and Charles A. Stanley, also highly regarded key opinion leaders in CHI. Dr. Ferrara received a M.D. and Ph.D. from Duke University School of Medicine.</div>

<div style="FONT-SIZE: 10pt; MARGIN-BOTTOM: 12pt; FONT-FAMILY: 'Times New Roman', Times, serif; MARGIN-TOP: 12pt; TEXT-ALIGN: left">"I am excited to join Rezolute as I believe RZ358 has the potential to become the primary treatment option for patients suffering with CHI, for whom there is often no adequate treatment," stated Dr. Ferrara. "In addition, I look forward to developing therapies that intersect with my area of patient-care and research focus, while continuing to care for patients and families affected by CHI."</div>

<div style="FONT-SIZE: 10pt; MARGIN-BOTTOM: 12pt; FONT-FAMILY: 'Times New Roman', Times, serif; MARGIN-TOP: 12pt; TEXT-ALIGN: left">"As a recognized key opinion leader and therapeutic area expert who manages patients with CHI, Dr. Ferrara is a fantastic addition to our team," said Nevan Elam, Chairman and Chief Executive Officer of Rezolute. "Current treatment options for CHI are ineffective, invasive or not well-tolerated. We look forward to Dr. Ferrara spearheading our late-stage clinical efforts for RZ358."</div>

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<div style="FONT-SIZE: 10pt; FONT-FAMILY: 'Times New Roman', Times, serif; TEXT-ALIGN: left"><font style="FONT-SIZE: 10pt; FONT-FAMILY: 'Times New Roman', Times, serif; FONT-WEIGHT: bold">About Rezolute, Inc.</font><font style="FONT-SIZE: 10pt; FONT-FAMILY: 'Times New Roman', Times, serif"><br>
</font>Rezolute is a clinical stage biopharmaceutical company specializing in the development of innovative drug therapies to improve the lives of patients with metabolic and orphan diseases. Rezolute is advancing a diversified pipeline including: RZ358 (Phase 2), an antibody for the ultra-orphan indication of Congenital HyperInsulinism (CHI), with an abbreviated path-to-market strategy; AB101 (Phase 1), a once-weekly injectable basal insulin with the potential to transform the treatment landscape in diabetes management by reducing the therapeutic burden for patients and improving compliance; and RZ402 (plan to file IND in H2 2018), a Plasma Kallikrein Inhibitor (PKI) targeting Diabetic Macular Edema (DME). For more information, visit: <font style="FONT-SIZE: 10pt; FONT-FAMILY: 'Times New Roman', Times, serif; FONT-VARIANT: normal; FONT-WEIGHT: normal; FONT-STYLE: normal"><u>www.rezolutebio.com</u></font>.</div>

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<div style="FONT-SIZE: 10pt; FONT-FAMILY: 'Times New Roman', Times, serif; TEXT-ALIGN: left"><font style="FONT-SIZE: 10pt; FONT-FAMILY: 'Times New Roman', Times, serif; FONT-WEIGHT: bold">Forward-Looking Statements</font><font style="FONT-SIZE: 10pt; FONT-FAMILY: 'Times New Roman', Times, serif"><br>
</font> 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 of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended. We intend such </div>

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<div style="FONT-SIZE: 10pt; FONT-FAMILY: 'Times New Roman', Times, serif; TEXT-ALIGN: left">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 "anticipate," "believe," "estimate," "expect," "intend," "plan," "project," "seek," "strive," "try," or future or conditional verbs such as "could," "may," "should," "will," "would," 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.</div>

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<div style="FONT-SIZE: 10pt; FONT-FAMILY: 'Times New Roman', Times, serif; FONT-WEIGHT: bold; TEXT-ALIGN: left">Rezolute, Inc. Contact:</div>

<div style="FONT-SIZE: 10pt; FONT-FAMILY: 'Times New Roman', Times, serif; TEXT-ALIGN: left">Noopur Liffick</div>

<div style="FONT-SIZE: 10pt; FONT-FAMILY: 'Times New Roman', Times, serif; TEXT-ALIGN: left">VP of Corporate Development</div>

<div style="FONT-SIZE: 10pt; FONT-FAMILY: 'Times New Roman', Times, serif; TEXT-ALIGN: left">(650) 549-4175</div>

<div style="FONT-SIZE: 10pt; FONT-FAMILY: 'Times New Roman', Times, serif; FONT-VARIANT: normal; FONT-WEIGHT: normal; FONT-STYLE: normal; TEXT-ALIGN: left"><u>investor-relations@rezolutebio.com</u></div>

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