<SEC-DOCUMENT>0001171843-20-000183.txt : 20200113
<SEC-HEADER>0001171843-20-000183.hdr.sgml : 20200113
<ACCEPTANCE-DATETIME>20200113063237
ACCESSION NUMBER:		0001171843-20-000183
CONFORMED SUBMISSION TYPE:	8-K
PUBLIC DOCUMENT COUNT:		2
CONFORMED PERIOD OF REPORT:	20200108
ITEM INFORMATION:		Departure of Directors or Certain Officers; Election of Directors; Appointment of Certain Officers: Compensatory Arrangements of Certain Officers
ITEM INFORMATION:		Regulation FD Disclosure
ITEM INFORMATION:		Financial Statements and Exhibits
FILED AS OF DATE:		20200113
DATE AS OF CHANGE:		20200113

FILER:

	COMPANY DATA:	
		COMPANY CONFORMED NAME:			BIOCRYST PHARMACEUTICALS INC
		CENTRAL INDEX KEY:			0000882796
		STANDARD INDUSTRIAL CLASSIFICATION:	BIOLOGICAL PRODUCTS (NO DIAGNOSTIC SUBSTANCES) [2836]
		IRS NUMBER:				621413174
		STATE OF INCORPORATION:			DE
		FISCAL YEAR END:			1231

	FILING VALUES:
		FORM TYPE:		8-K
		SEC ACT:		1934 Act
		SEC FILE NUMBER:	000-23186
		FILM NUMBER:		20522690

	BUSINESS ADDRESS:	
		STREET 1:		4505 EMPEROR BOULEVARD
		STREET 2:		SUITE 200
		CITY:			DURHAM
		STATE:			NC
		ZIP:			27703
		BUSINESS PHONE:		919-859-1302

	MAIL ADDRESS:	
		STREET 1:		4505 EMPEROR BOULEVARD
		STREET 2:		SUITE 200
		CITY:			DURHAM
		STATE:			NC
		ZIP:			27703
</SEC-HEADER>
<DOCUMENT>
<TYPE>8-K
<SEQUENCE>1
<FILENAME>f8k_011320.htm
<DESCRIPTION>FORM 8-K
<TEXT>
<html><head><title></title></head><body><div style="margin-top: 3pt; margin-bottom: 12pt;"><div style="font-size: 1pt; border-top: Black 2.5pt solid; border-bottom: Black 1.1pt solid; width: 100%;"><font style="font-size: 10pt;">&#160;</font></div></div><p style="text-align: center;"><font style="font-size: 14pt;"><strong>UNITED STATES</strong><br /><strong>SECURITIES AND EXCHANGE COMMISSION</strong><br /><strong>Washington, D.C. 20549</strong><br />_____________________</font></p><p style="text-transform: uppercase; text-align: center;"><font style="font-size: 14pt;"><strong>Form 8-K</strong><br />_____________________</font></p><p style="text-align: center;"><font style="font-size: 12pt;"><strong>CURRENT REPORT</strong></font></p><p style="text-align: center;"><font style="font-size: 12pt;"><strong>Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934</strong></font></p><p align="center"><font style="font-size: 10pt;">Date of Report (Date of earliest event Reported): <!--January 12, 2020-->January 8, 2020 &#160;</font></p><p align="center"><font style="font-size: 12pt;"><strong>BioCryst Pharmaceuticals, Inc.</strong></font><br /><font style="font-size: 10pt;">(Exact Name of Registrant as Specified in Charter)</font></p><table style="width: 100%;" border="0" cellspacing="0" cellpadding="0"><tr valign="top"><td align="center" width="33%"><font style="font-size: 10pt;"><strong>Delaware</strong></font></td><td align="center" width="34%"><font style="font-size: 10pt;"><strong>000-23186</strong></font></td><td align="center" width="33%"><font style="font-size: 10pt;"><strong>62-1413174</strong></font></td></tr><tr valign="top"><td align="center" width="33%"><font style="font-size: 10pt;">(State or Other Jurisdiction of Incorporation)</font></td><td align="center" width="34%"><font style="font-size: 10pt;">(Commission File Number)</font></td><td align="center" width="33%"><font style="font-size: 10pt;">(I.R.S. Employer Identification Number)</font></td></tr></table><p><font style="font-size: 10pt;">&#160;</font></p><table style="width: 100%;" border="0" cellspacing="0" cellpadding="0"><tr valign="bottom"><td align="center" width="50%"><font style="font-size: 10pt;"><strong>4505 Emperor Blvd., Suite 200, Durham, North Carolina 27703</strong><!----></font></td></tr><tr valign="top"><td align="center" width="50%"><font style="font-size: 10pt;">(Address of Principal Executive Offices) (Zip Code)</font></td></tr></table><p align="center"><font style="font-size: 10pt;"><strong>(919) 859-1302</strong><br />(Registrant's telephone number, including area code)</font></p><p align="center"><font style="font-size: 10pt;"><strong></strong><br />(Former name or former address, if changed since last report)</font></p><table style="width: 100%;" border="0" cellspacing="0" cellpadding="0"><tr valign="top"><td colspan="3"><font style="font-size: 10pt;">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:<br /><br /></font></td></tr><tr valign="top"><td width="21"><font style="font-size: 10pt;">&#160;</font></td><td width="40"><font style="font-size: 10pt;">[ &#160; 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[&#160;&#160; ]&#160;</p><hr style="page-break-after: always;" noshade="noshade" /><p><font style="font-size: 10pt;">  <strong>  </strong></font></p><p><font style="font-size: 10pt;"><strong>Item 5.02. Departure of Directors or Certain Officers; Election of Directors; Appointment of Certain Officers; Compensatory Arrangements of Certain Officers.</strong></font></p><p><font style="font-size: 10pt;">
 <p><font style="font-size:10pt; font-family:'times new roman';">On January 8, 2020, BioCryst Pharmaceuticals, Inc. (the &#8220;Company&#8221;) appointed Michael L. Jones to the position of Executive Director, Finance &amp; Principal Accounting Officer. Mr. Jones assumed the role of principal accounting officer from Thomas R. Staab, II, the Company&#8217;s Senior Vice President, Chief Financial Officer and Treasurer, who will remain the Company&#8217;s principal financial officer until his previously announced departure in February 2020.</font></p>    <p><font style="font-size:10pt; font-family:'times new roman';">Mr. Jones, 50, joined the Company in 2011 and has served as the Company&#8217;s Director, Financial Accounting since 2013. Prior to joining the Company, he held various finance and accounting positions with Talecris Biotherapeutics, Inc., a biopharmaceutical company, and Salix Pharmaceuticals, Inc., a specialty pharmaceutical company. He is a certified public accountant and holds a B.A. in Business Administration from North Carolina State University and a Master of Business Administration from the University of South Carolina.</font></p>    <p><font style="font-size:10pt; font-family:'times new roman';">Mr. Jones will receive a base salary of $209,605 annually, with a target percentage under the Company&#8217;s Annual Incentive Plan (&#8220;AIP&#8221;) of 25% of base salary.  </font></p>    <p><font style="font-size:10pt; font-family:'times new roman';">Mr. Jones does not have a family relationship with any of the Company&#8217;s officers or directors and has no direct or indirect interest in any transaction required to be disclosed pursuant to Item 404(a) of Regulation S-K.</font></p> </font></p><p><font style="font-size: 10pt;"><strong>  </strong></font></p><p><font style="font-size: 10pt;"><strong>Item 7.01. Regulation FD Disclosure.</strong></font></p><p><font style="font-size: 10pt;">
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 <p style="margin-left:0in; margin-right:0in;"><font color="black" style="font-size:10pt; font-family:'times new roman';"><font style="color:black; font-size:10pt; font-family:'times new roman';">(d) Exhibits</font></font></p> <table style="width:700; border-collapse:collapse !important;;border-collapse: collapse; "><tr><td style="vertical-align: bottom ; "><font style="font-size:10pt; font-family:'times new roman';"><strong><u>Exhibit No.</u></strong></font></td><td class="hugin"><font style="font-size:10pt; font-family:'times new roman';">&#160;</font></td><td style="vertical-align: bottom ; "><font style="font-size:10pt; font-family:'times new roman';"><strong><u>Description</u></strong></font></td></tr><tr><td class="hugin"><font style="font-size:10pt; font-family:'times new roman';">&#160;</font></td><td class="hugin"><font style="font-size:10pt; font-family:'times new roman';">&#160;</font></td><td class="hugin"><font style="font-size:10pt; font-family:'times new roman';">&#160;</font></td></tr><tr><td class="hugin"><font style="font-size:10pt; font-family:'times new roman';"><font style="font-size:10pt; font-family:'times new roman';"><a href="exh_991.htm" rel="nofollow">99.1</a></font></font></td><td class="hugin"><font style="font-size:10pt; font-family:'times new roman';">&#160;</font></td><td class="hugin"><font style="font-size:10pt; font-family:'times new roman';"><font style="font-size:10pt; font-family:'times new roman';"><a href="exh_991.htm" rel="nofollow">Press release dated January 12, 2020 entitled &#8220;BioCryst to Provide Berotralstat and BXC9930 Program Updates at 38th Annual J.P. Morgan Healthcare Conference.&#8221;</a></font>&#160;</font></td></tr></table></font></p><p><font style="font-size: 10pt;"></font></p><p><font style="font-size: 10pt;"></font></p><hr style="page-break-after: always;" noshade="noshade" /><p align="center"><font style="font-size: 10pt;"><strong>SIGNATURE</strong></font></p><p><font style="font-size: 10pt;">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.</font></p><table style="width: 100%;" border="0" cellspacing="0" cellpadding="0"><tr valign="top"><td valign="top" width="49%"><font style="font-size: 10pt;">&#160;</font></td><td style="font-size: 12pt;" colspan="2" valign="top"><font style="font-size: 10pt;"><strong>BioCryst Pharmaceuticals, Inc.</strong></font></td></tr><tr valign="top"><td width="49%"><font style="font-size: 10pt;">&#160;</font></td><td width="2%"><font style="font-size: 10pt;">&#160;</font></td><td width="49%"><font style="font-size: 10pt;">&#160;</font></td></tr><tr valign="top"><td width="49%"><font style="font-size: 10pt;">&#160;</font></td><td width="2%"><font style="font-size: 10pt;">&#160;</font></td><td width="49%"><font style="font-size: 10pt;"></font></td></tr><tr valign="top"><td width="49%"><font style="font-size: 10pt;">Date: January 13, 2020</font></td><td width="2%"><font style="font-size: 10pt;">By:&#160;</font></td><td style="text-decoration: underline;" width="49%"><font style="font-size: 10pt;">/s/ Alane Barnes&#160;&#160;&#160;&#160;&#160;&#160;&#160;&#160;</font></td></tr><tr valign="top"><td width="49%"><font style="font-size: 10pt;">&#160;</font></td><td width="2%"><font style="font-size: 10pt;">&#160;</font></td><td width="49%"><font style="font-size: 10pt;">Alane Barnes</font></td></tr><tr valign="top"><td width="49%"><font style="font-size: 10pt;">&#160;</font></td><td width="2%"><font style="font-size: 10pt;">&#160;</font></td><td width="49%"><font style="font-size: 10pt;">Senior Vice President and Chief Legal Officer</font></td></tr><tr valign="top"><td width="49%"><font style="font-size: 10pt;">&#160;</font></td><td width="2%"><font style="font-size: 10pt;">&#160;</font></td><td width="49%"><font style="font-size: 10pt;"></font></td></tr></table><p /></body></html>
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<TYPE>EX-99.1
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<!DOCTYPE HTML PUBLIC "-//W3C//DTD HTML 4.0 Transitional//EN"><html lang="en-US"><head><title>EdgarFiling</title><meta content="text/html; charset=windows-1252" ><meta name="GENERATOR" content="MSHTML 8.00.7601.18094" ></head><body bgcolor="#ffffff"><p style="text-align: right;"><strong>EXHIBIT 99.1</strong></p><p style="text-align: center;"><font style="font-size: 14pt;"><strong>BioCryst to Provide Berotralstat and BCX9930 Program Updates at 38th Annual J.P. Morgan Healthcare Conference</strong></font></p><p style="text-align: center;"><strong></strong></p><p ></p>
 <p align="justify">RESEARCH TRIANGLE PARK, N.C., Jan.  12, 2020  (GLOBE NEWSWIRE) -- BioCryst Pharmaceuticals, Inc. (Nasdaq:&#160;BCRX) today announced that the company will provide updates on berotralstat, an oral kallikrein inhibitor for hereditary angioedema (HAE), and BCX9930, an oral Factor D inhibitor for complement-mediated diseases, this week at the 38<sup>th</sup> Annual J.P. Morgan Healthcare Conference in San Francisco.&#160; &#160;<br ></p>  <p align="justify">&#8220;BioCryst is positioned for transformation in 2020 with multiple global approvals and launches of berotralstat, and PNH proof of concept data with BCX9930. The $100 million in additional capital we brought into the company in Q4 2019 provides a foundation for progress and value creation in 2020,&#8221; said Jon Stonehouse, president and chief executive officer of BioCryst.</p>  <p align="justify"><strong><u>Berotralstat Program Updates:</u></strong></p>  <ul type="disc"><li>New drug application (NDA) submitted to U.S Food and Drug Administration in December 2019<br >&#160;</li><li>APeX-J trial in Japan met its primary endpoint (p=0.003) for prevention of HAE attacks, and berotralstat was safe and generally well-tolerated<br >&#160;</li><li>JNDA submission to Japanese Pharmaceuticals and Medical Devices Agency (PMDA) on-track for Q1 2020<br >&#160;</li><li>Marketing authorization application to European Medicines Agency (EMA) on-track for Q1 2020</li></ul>  <p align="justify"><strong><u>BCX9930 Program Updates:</u></strong></p>  <p align="justify">As previously announced, results from an ongoing three part Phase 1 trial of BCX9930 showed rapid, sustained and &gt;95% suppression of the alternative pathway (AP) of the complement system at 100 mg every 12 hours, as measured by the AP Wieslab<sup>&#174;</sup> assay.</p>  <p align="justify">In two initial multiple ascending dose (MAD) assessment cohorts, healthy volunteers received 50 mg or 100 mg of oral BCX9930 or placebo (each MAD cohort randomized 10:2) administered every 12 hours for seven days. Healthy volunteers in the MAD cohorts were prophylactically dosed with the broad-spectrum antibiotic, amoxicillin/clavulanate.&#160; BCX9930 was safe and generally well tolerated at all doses studied in single ascending dose and MAD cohorts. There were no serious adverse events. A clinically benign rash was observed in some healthy volunteers in the MAD (two in the 50 mg cohort, seven in the 100 mg cohort), which was self-limited and resolved in 4-8 days after onset.</p>  <p align="justify">The company has now completed an additional MAD cohort with 50 mg of oral BCX9930 or placebo administered every 12 hours for 14 days, with vaccination instead of an antibiotic. Key observations from the additional MAD cohort include:</p>  <ul type="disc"><li>Benign rash (similar to prior MAD cohorts) that was self-limited and resolved in 4 to 8 days post-onset seen in seven healthy volunteers<br >&#160;</li><li>Successfully dosed-through benign rash, with rash resolving on-drug, in both patients who continued dosing, per protocol<br >&#160;</li><li>Biopsies of rashes from multiple subjects confirm benign assessment</li></ul>  <p align="justify">The company is on-track to report proof of concept data in paroxysmal nocturnal hemoglobinuria (PNH) patients in 1H 2020.</p>  <p align="justify">Additional details can be found on slides, which can be accessed at may be accessed in the Investors section of BioCryst&#8217;s website at http://www.biocryst.com.</p>  <p><strong>About BioCryst Pharmaceuticals </strong></p>  <p align="justify">BioCryst Pharmaceuticals discovers novel, oral small-molecule medicines that treat rare diseases in which significant unmet medical needs exist and an enzyme plays a key role in the biological pathway of the disease. BioCryst has several ongoing development programs including berotralstat (BCX7353), an oral treatment for hereditary angioedema, BCX9930, an oral Factor D inhibitor for the treatment of complement-mediated diseases, galidesivir, a potential treatment for Marburg virus disease and Yellow Fever, and BCX9250, an oral ALK-2 inhibitor for the treatment of fibrodysplasia ossificans progressiva (FOP). RAPIVAB<sup>&#174;</sup> (peramivir injection), a viral neuraminidase inhibitor for the treatment of influenza, is BioCryst&#8217;s first approved product and has received regulatory approval in the U.S., Canada, Australia, Japan, Taiwan, Korea and the European Union. Post-marketing commitments for RAPIVAB are ongoing. For more information, please visit the company&#8217;s website at www.BioCryst.com.</p>  <p><strong>Forward-Looking Statements </strong></p>  <p align="justify">This press release contains forward-looking statements, including statements regarding future results, performance or achievements. These statements involve known and unknown risks, uncertainties and other factors which may cause BioCryst&#8217;s actual results, performance or achievements to be materially different from any future results, performances or achievements expressed or implied by the forward-looking statements. These statements reflect our current views with respect to future events and are based on assumptions and are subject to risks and uncertainties. Given these uncertainties, you should not place undue reliance on these forward-looking statements. Some of the factors that could affect the forward-looking statements contained herein include: that developing any HAE product candidate may take longer or may be more expensive than planned; that ongoing and future preclinical and clinical development of BCX9930 or BCX9250 may not have positive results; that BioCryst may not be able to enroll the required number of subjects in planned clinical trials of product candidates; that the company may not advance human clinical trials with product candidates as expected; that the FDA, EMA, PMDA or other applicable regulatory agency may require additional studies beyond the studies planned for product candidates, or may not provide regulatory clearances which may result in delay of planned clinical trials, or may impose a clinical hold with respect to such product candidate, or withhold market approval for product candidates. Please refer to the documents BioCryst files periodically with the Securities and Exchange Commission, specifically BioCryst&#8217;s most recent Annual Report on Form 10-K, Quarterly Reports on Form 10-Q, and Current Reports on Form 8-K, all of which identify important factors that could cause the actual results to differ materially from those contained in BioCryst&#8217;s projections and forward-looking statements.</p>  <p>BCRXW</p>  <p><strong><u>Contact:</u></strong><br >John Bluth<br >+1 919 859 7910<br >jbluth@biocryst.com</p>  <p> </p><p ></p></body></html>
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