<SEC-DOCUMENT>0001157523-19-002316.txt : 20191204
<SEC-HEADER>0001157523-19-002316.hdr.sgml : 20191204
<ACCEPTANCE-DATETIME>20191203175358
ACCESSION NUMBER:		0001157523-19-002316
CONFORMED SUBMISSION TYPE:	6-K
PUBLIC DOCUMENT COUNT:		2
CONFORMED PERIOD OF REPORT:	20191203
FILED AS OF DATE:		20191204
DATE AS OF CHANGE:		20191203

FILER:

	COMPANY DATA:	
		COMPANY CONFORMED NAME:			Aurinia Pharmaceuticals Inc.
		CENTRAL INDEX KEY:			0001600620
		STANDARD INDUSTRIAL CLASSIFICATION:	PHARMACEUTICAL PREPARATIONS [2834]
		IRS NUMBER:				000000000
		STATE OF INCORPORATION:			A0
		FISCAL YEAR END:			1231

	FILING VALUES:
		FORM TYPE:		6-K
		SEC ACT:		1934 Act
		SEC FILE NUMBER:	001-36421
		FILM NUMBER:		191266641

	BUSINESS ADDRESS:	
		STREET 1:		#1203-4464 MARKHAM STREET
		CITY:			VICTORIA BC
		STATE:			A1
		ZIP:			V8Z 7X8
		BUSINESS PHONE:		250-708-4272

	MAIL ADDRESS:	
		STREET 1:		#1203-4464 MARKHAM STREET
		CITY:			VICTORIA BC
		STATE:			A1
		ZIP:			V8Z 7X8
</SEC-HEADER>
<DOCUMENT>
<TYPE>6-K
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<DESCRIPTION>AURINIA PHARMACEUTICALS INC. 6-K
<TEXT>
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    <div style="text-align: center; margin-top: 0.65pt; font-family: 'Times New Roman',Times,serif; font-size: 18pt; font-weight: bold;">UNITED STATES</div>
    <div style="text-align: center; font-family: 'Times New Roman',Times,serif; font-size: 16pt; font-weight: bold;">SECURITIES AND EXCHANGE COMMISSION</div>
    <div style="text-align: center; margin-bottom: 17.1pt; font-weight: bold;">Washington, D.C. 20549</div>
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    <div style="text-align: center; margin-top: 19.6pt; margin-bottom: 17.2pt; font-family: 'Times New Roman',Times,serif; font-size: 16pt; font-weight: bold;">FORM 6-K</div>
    <div style="font-family: 'Times New Roman',Times,serif; font-weight: 400;">
      <hr noshade="noshade" align="center" style="height: 2px; color: #000000; background-color: #000000; text-align: center; margin-left: auto; margin-right: auto; border: none;"> </div>
    <div style="text-align: center; margin-top: 19.5pt; font-weight: bold;">REPORT OF FOREIGN PRIVATE ISSUER<br>
      PURSUANT TO RULE 13A-16 OR 15D-16 UNDER THE<br>
      SECURITIES EXCHANGE ACT OF 1934</div>
    <div style="text-align: center; margin-top: 9.9pt; font-weight: bold;">Dated December 3, 2019</div>
    <div style="text-align: center; margin-top: 9.95pt; margin-bottom: 17.3pt; font-weight: bold;">Commission File Number 001-36421</div>
    <div style="font-weight: 400; font-family: 'Times New Roman',Times,serif;">
      <hr noshade="noshade" align="center" style="height: 2px; color: #000000; background-color: #000000; text-align: center; margin-left: auto; margin-right: auto; border: none;"> </div>
    <div style="text-align: center; margin-top: 20pt; font-family: 'Times New Roman',Times,serif; font-size: 16pt; font-weight: bold;">AURINIA PHARMACEUTICALS INC.</div>
    <div style="text-align: center; margin-bottom: 17.1pt; font-weight: bold;">(Exact name of Registrant as specified in its charter)</div>
    <div style="font-weight: 400; font-family: 'Times New Roman',Times,serif;">
      <hr noshade="noshade" align="center" style="height: 2px; color: #000000; background-color: #000000; text-align: center; margin-left: auto; margin-right: auto; border: none;"> </div>
    <div style="text-align: center; margin-top: 19.45pt; font-weight: bold;">N/A</div>
    <div style="text-align: center; font-weight: bold;">(Translation of Registrant&#8217;s Name)</div>
    <div style="text-align: center; margin-top: 13.3pt; margin-bottom: 17.05pt; font-weight: bold;">#1203-4464 Markham Street<br>
      Victoria, British Columbia<br>
      V8Z7X8<br>
      (250) 708-4272<br>
      (Address and telephone number of registrant&#8217;s principal executive offices)</div>
    <div style="font-weight: 400; font-family: 'Times New Roman',Times,serif;">
      <hr noshade="noshade" align="center" style="height: 2px; color: #000000; background-color: #000000; text-align: center; margin-left: auto; margin-right: auto; border: none;"> </div>
    <div style="margin-left: 21.6pt; margin-top: 19.4pt;">Indicate by check mark whether the registrant files or will file annual reports under cover of Form 20-F or Form 40-F.</div>
    <div style="margin-left: 21.6pt; margin-top: 19.4pt; text-align: center;">Form 20-F &#9744; Form 40-F &#9746;</div>
    <div style="font-family: 'Times New Roman',Times,serif;"> <br>
    </div>
    <div style="font-family: 'Times New Roman',Times,serif;"><font class="HorizontalTab" style="width: 8pt; font-size: 1px; display: inline-block;">&#160;</font><font class="HorizontalTab" style="width: 8pt; font-size: 1px; display: inline-block;">&#160;</font><font class="HorizontalTab" style="width: 8pt; font-size: 1px; display: inline-block;">&#160;</font>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): &#9744;</div>
    <div style="font-family: 'Times New Roman',Times,serif;"> <br>
    </div>
    <div style="font-family: 'Times New Roman',Times,serif;"><font class="HorizontalTab" style="width: 8pt; font-size: 1px; display: inline-block;">&#160;</font><font class="HorizontalTab" style="width: 8pt; font-size: 1px; display: inline-block;">&#160;</font><font class="HorizontalTab" style="width: 8pt; font-size: 1px; display: inline-block;">&#160;</font>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): &#9744;</div>
    <div style="text-align: justify; text-indent: 21.6pt; margin-top: 14.2pt;">Indicate by check mark whether by furnishing the information contained in this Form, the registrant is also thereby furnishing the information to the Commission pursuant to Rule
      12g3-2(b) under the Securities Exchange Act of 1934.</div>
    <div style="font-family: 'Times New Roman',Times,serif;"> <br>
    </div>
    <div style="text-align: center; font-family: 'Times New Roman',Times,serif;"> Yes &#9746; No &#9744;</div>
    <div style="text-indent: 21.6pt; margin-right: 14.4pt; margin-top: 13.9pt;">This Form 6-K is hereby filed and incorporated by reference in the registrant&#8217;s Registration Statement on Form F-10 (File No. 333-222413).</div>
    <div style="text-indent: 21.6pt; margin-right: 14.4pt; margin-top: 13.9pt;"> </div>
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    <div style="text-align: center; margin-top: 0.6pt; font-weight: bold;">SIGNATURES</div>
    <div style="text-align: justify; text-indent: 21.6pt; margin-right: 3.6pt; margin-top: 13.25pt;">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="margin-top: 13.45pt;">Dated: December 3, 2019</div>
    <div style="margin-top: 13.45pt;">
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            <td valign="top" colspan="2" style="width: 38%;"><strong></strong><font style="font-weight: bold;">Aurinia Pharmaceuticals Inc.</font></td>
            <td valign="top" style="width: 12%;">&#160;</td>
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            <td valign="top" style="width: 50%;">&#160;</td>
            <td valign="top" style="width: 3%;">&#160;</td>
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              <div align="left" style="margin-left: 0pt; text-indent: 0pt; margin-right: 0pt;">By: </div>
            </td>
            <td valign="top" align="left" style="width: 35%; border-bottom: #000000 2px solid;">/s/ Peter S. Greenleaf </td>
            <td valign="top" style="width: 12%; padding-bottom: 2px;">&#160;</td>
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            <td valign="top" style="width: 3%;">&#160;</td>
            <td valign="bottom" align="left" style="width: 35%;">Name: Peter S. Greenleaf </td>
            <td valign="top" style="width: 12%;">&#160;</td>
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            <td valign="top" style="width: 3%;">&#160;</td>
            <td valign="top" style="width: 35%;">Title: Chief Executive Officer</td>
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    <div style="text-align: center; margin-top: 0.3pt; font-weight: bold;">EXHIBIT INDEX</div>
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              <div><font style="font-weight: bold;">Exhibit</font><font id="TRGRRTFtoHTMLTab" style="display: inline-block; text-indent: 0px; font-size: 1px; width: 61.2pt"> <br>
                </font></div>
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              <div><font style="font-weight: bold;">Description of Exhibit</font></div>
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            </td>
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              <div><a href="a52138664ex99_1.htm">99.1</a></div>
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              <div>&#160;</div>
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            <td style="width: 88%; font-family: 'Times New Roman',Times,serif; text-align: left;">
              <div><a href="a52138664ex99_1.htm">News Release - AURINIA TO PRESENT PRECLINICAL VOCLOSPORIN DATA AT 2020 KEYSTONE SYMPOSIA CONFERENCE</a></div>
            </td>
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    </div>
    <div style="margin-right: 14.4pt; margin-top: 14.35pt;">Exhibit 99.1 included with this report on Form 6-K is hereby incorporated by reference as exhibits to the Registration Statement on Form F-10 of Aurinia Pharmaceuticals Inc. (File No. 333-222413),
      as amended or supplemented.</div>
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<TYPE>EX-99.1
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<FILENAME>a52138664ex99_1.htm
<DESCRIPTION>EXHIBIT 99.1
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      <div class="bw-release">
        <h1 style="text-align: center; list-style-position:inside;FONT-SIZE: 14pt;"> <b>Aurinia to Present Preclinical Voclosporin Data at 2020 Keystone Symposia Conference </b> </h1>
        <div class="bw-release-subhead">
          <p style="text-align: center; list-style-position:inside;"><b> <b>- Voclosporin demonstrated fewer adverse effects on beta cell function as compared to tacrolimus in preclinical model of diabetes -</b> </b></p>
          <p style="text-align: center; list-style-position:inside;"><b> <b>- Data supports differentiation of voclosporin versus legacy CNIs and potential best-in-class attributes -</b> </b></p>
          <p style="text-align: center; list-style-position:inside;"><b> <b>- Data to be presented at the Keystone Symposia Conference on Islet Cell Biology - </b> </b></p>
        </div>
        <div class="bw-release-body">
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            <p>VICTORIA, British Columbia--(BUSINESS WIRE)--December 3, 2019--Aurinia Pharmaceuticals Inc. (NASDAQ: AUPH / TSX:AUP) (&#8220;Aurinia&#8221; or the &#8220;Company&#8221;), a late-stage clinical biopharmaceutical company focused on advancing voclosporin across
              multiple inflammatory and autoimmune conditions, today announced that an abstract has been accepted for presentation at the Keystone Symposia Conference on Islet Biology: From Gene to Cell to Micro-Organ in Santa Fe, New Mexico from January
              27-31, 2020. The abstract will be presented by Dr. James D. Johnson, Professor of Medicine in the Department of Cellular and Physiological Sciences and the Department of Surgery at the University of British Columbia (UBC). Professor Johnson
              is founding member of the Life Sciences Institute Diabetes Research Group and current Editor-in-Chief of the journal <i>Islets</i>. </p>
            <p> The abstract entitled, <i>Tacrolimus, but not voclosporin, significantly inhibits insulin exocytosis from human islets at clinically relevant trough concentrations, </i>will discuss preclinical<i> </i>data comparing the effects of
              tacrolimus and voclosporin on the function and survival of human insulin producing beta cells. Legacy calcineurin inhibitors (&#8220;CNIs&#8221;) have been a mainstay of treatment for the prevention of rejection after solid organ transplant for decades.
              In this setting, patients have developed new onset diabetes after transplant (NODAT) as a relatively common but serious side effect.<sup style="vertical-align: text-top; line-height: 1; font-size: smaller;">1</sup> In a past clinical study, voclosporin was shown to be significantly less diabetogenic than
              tacrolimus in the renal transplant setting.<sup style="vertical-align: text-top; line-height: 1; font-size: smaller;">2</sup> In the recently published AURA-LV study in subjects with active lupus nephritis, voclosporin was shown to have no adverse clinical impact on glucose parameters. </p>
            <p> In this <i>in vitro</i> study, human islets were treated with clinically relevant concentrations approximating the peak and trough concentrations of tacrolimus or voclosporin. At these trough concentrations tacrolimus, but not voclosporin,
              caused a statistically significant impairment of insulin secretion at the distal stages of exocytosis. Transcriptome sequencing identified novel effects of calcineurin inhibitors on genes responsible for the regulation of cellular exocytic
              machinery and these effects were more marked with tacrolimus. </p>
            <p> &#8220;We are very happy with these preclinical results,&#8221; stated Dr. Robert Huizinga, Executive Vice President Corporate Development at Aurinia. &#8220;These data, combined with our reported clinical experience with voclosporin with respect to a
              potentially low diabetic potential of this agent provide additional understanding into the mechanistic rationale as to why we see a limited adverse impact on beta cell function with voclosporin, which supports our reported clinical experience
              with respect to the very low diabetic potential of this agent.&#8221; </p>
            <p> The results of this study will be incorporated in a potential New Drug Application (NDA) the company expects to file during the first half of 2020. </p>
            <p> <i>1. Webster et al., British Medical Journal. 2005; Oct. 8<sup style="vertical-align: text-top; line-height: 1; font-size: smaller;">th</sup>; 331(7520); 810</i> </p>
            <p> <i>2. Busque et al., American Journal of Transplantation. 2011;11(12):2675-2684</i> </p>
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            </div>
            <p> <b><u>Full Presentation Details</u></b> </p>
            <p> <b>Title</b>: <i>Tacrolimus, but not voclosporin, significantly inhibits insulin exocytosis from human islets at clinically relevant trough concentrations </i>(Poster #2004) </p>
            <p> <b>Presenter:</b> Dr. James D. Johnson, Professor of Medicine in the Department of Cellular and Physiological Sciences and the Department of Surgery at the University of British Columbia (UBC) </p>
            <p> <b>Date</b>: Wednesday, January 29, 2020 </p>
            <p> <b>Location:</b> Santa Fe Community Convention Center - Poster Session 2, Sweeney F, Main Level Breakout Room </p>
            <p> <b>About Aurinia </b> </p>
            <p> Aurinia Pharmaceuticals is a late clinical-stage biopharmaceutical company focused on developing and commercializing therapies to treat targeted patient populations that are impacted by serious diseases with a high unmet medical need. The
              Company is currently developing an investigational drug, for the treatment of Lupus Nephritis, Focal Segmental Glomerulosclerosis and Dry Eye Syndrome. The Company&#8217;s head office is in Victoria, British Columbia and focuses its development
              efforts globally. For further information, see our website at www.auriniapharma.com. </p>
            <p> <b>About Voclosporin </b> </p>
            <p> Voclosporin, an investigational drug, is a novel and potentially best-in-class calcineurin inhibitor (&#8220;CNI&#8221;) with clinical data in over 2,600 patients across indications. Voclosporin is an immunosuppressant, with a synergistic and dual
              mechanism of action. By inhibiting calcineurin, voclosporin blocks IL-2 expression and T-cell mediated immune responses and stabilizes the podocyte in the kidney. It has been shown to have a more predictable pharmacokinetic and
              pharmacodynamic relationship (potentially requires no therapeutic drug monitoring), an increase in potency (vs cyclosporin), and an improved metabolic profile compared to legacy CNIs. Aurinia anticipates that upon regulatory approval, patent
              protection for voclosporin will be extended in the United States and certain other major markets, including Europe and Japan, until at least October 2027 under the <i>Hatch-Waxman Act</i> and comparable laws in other countries and until
              April 2028 with anticipated pediatric extension. Further, the new Notice of Allowance<b> </b>is expected to result in the issuance of a U.S. patent with a term extending to December 2037. If the FDA approves the use of voclosporin for LN and
              the label for such use follows the dosing protocol under the Notice of Allowance, the issuance of this patent will expand the scope of intellectual property protection for voclosporin to December 2037. </p>
            <p> <b><i>Forward-Looking Statements</i></b> </p>
            <p> Certain statements made in this press release may constitute forward-looking information within the meaning of applicable Canadian securities law and forward-looking statements within the meaning of applicable United States securities law.
              These forward-looking statements or information include but are not limited to statements or information with respect to: preclinical data comparing the effects of tacrolimus and voclosporin on the function and survival of human insulin
              producing beta cells and the implications of such findings; voclosporin being potentially a best-in-class CNI with robust intellectual property exclusivity; Aurinia&#8217;s anticipation that upon regulatory approval, patent protection for
              voclosporin will be extended in the United States and certain other major markets, including Europe and Japan, until at least October 2027 under the Hatch-Waxman Act and comparable laws in other countries and until April 2028 with anticipated
              pediatric extension; that the new Notice of Allowance is expected to result in the issuance of a U.S. patent with a term extending to December 2037; that if the FDA approves the use of voclosporin for LN and the label for such use follows the
              dosing protocol under the Notice of Allowance, the issuance of this patent will expand the scope of intellectual property protection for voclosporin to December 2037. It is possible that such results or conclusions may change based on further
              analyses of these data. Words such as &#8220;anticipate&#8221;, &#8220;will&#8221;, &#8220;believe&#8221;, &#8220;estimate&#8221;, &#8220;expect&#8221;, &#8220;intend&#8221;, &#8220;target&#8221;, &#8220;plan&#8221;, &#8220;goals&#8221;, &#8220;objectives&#8221;, &#8220;may&#8221; and other similar words and expressions, identify forward-looking statements. We have made
              numerous assumptions about the forward-looking statements and information contained herein, including among other things, assumptions about: the market value for the LN, DES and FSGS programs; that another company will not create a
              substantial competitive product for Aurinia&#8217;s LN, DES and FSGS business without violating Aurinia&#8217;s intellectual property rights; the burn rate of Aurinia&#8217;s cash for operations; the costs and expenses associated with Aurinia&#8217;s clinical
              trials; the planned studies achieving positive results; Aurinia being able to extend and protect its patents on terms acceptable to Aurinia; and the size of the LN, DES or FSGS markets. Even though the management of Aurinia believes that the
              assumptions made, and the expectations represented by such statements or information are reasonable, there can be no assurance that the forward-looking information will prove to be accurate. </p>
            <p> Forward-looking information by their nature are based on assumptions and involve known and unknown risks, uncertainties and other factors which may cause the actual results, performance or achievements of Aurinia to be materially different
              from any future results, performance or achievements expressed or implied by such forward-looking information. Should one or more of these risks and uncertainties materialize, or should underlying assumptions prove incorrect, actual results
              may vary materially from those described in forward-looking statements or information. Such risks, uncertainties and other factors include, among others, the following: difficulties, delays, or failures we may experience in the conduct of our
              clinical trial; difficulties we may experience in completing the development and commercialization of voclosporin; the market for the LN, DES and FSGS business may not be as estimated; Aurinia may have to pay unanticipated expenses; estimated
              costs for clinical trials may be underestimated, resulting in Aurinia having to make additional expenditures to achieve its current goals; Aurinia not being able to extend or fully protect its patent portfolio for voclosporin; and competitors
              may arise with similar products. Although we have attempted to identify factors that would cause actual actions, events or results to differ materially from those described in forward-looking statements and information, there may be other
              factors that cause actual results, performances, achievements or events to not be as anticipated, estimated or intended. Also, many of the factors are beyond our control. There can be no assurance that forward-looking statements or
              information will prove to be accurate, as actual results and future events could differ materially from those anticipated in such statements. Accordingly, you should not place undue reliance on forward-looking statements or information. </p>
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            <p> Except as required by law, Aurinia will not update forward-looking information. All forward-looking information contained in this press release is qualified by this cautionary statement. Additional information related to Aurinia, including
              a detailed list of the risks and uncertainties affecting Aurinia and its business can be found in Aurinia&#8217;s most recent Annual Information Form available by accessing the Canadian Securities Administrators&#8217; System for Electronic Document
              Analysis and Retrieval (SEDAR) website at www.sedar.com or the U.S. Securities and Exchange Commission&#8217;s Electronic Document Gathering and Retrieval System (EDGAR) website at www.sec.gov/edgar. </p>
            <p> <i>We seek Safe Harbor</i>. </p>
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          <div class="bw-release-contact">
            <h2 style="FONT-SIZE: 14pt;">Contacts</h2>
            <p> <b>Investor &amp; Media: </b><br>
              Glenn Schulman, PharmD, MPH <br>
              Corporate Communications, Aurinia <br>
              gschulman@auriniapharma.com </p>
          </div>
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