<SEC-DOCUMENT>0001193125-19-171768.txt : 20190613
<SEC-HEADER>0001193125-19-171768.hdr.sgml : 20190613
<ACCEPTANCE-DATETIME>20190613060753
ACCESSION NUMBER:		0001193125-19-171768
CONFORMED SUBMISSION TYPE:	6-K
PUBLIC DOCUMENT COUNT:		2
CONFORMED PERIOD OF REPORT:	20190613
FILED AS OF DATE:		20190613
DATE AS OF CHANGE:		20190613

FILER:

	COMPANY DATA:	
		COMPANY CONFORMED NAME:			NuCana plc
		CENTRAL INDEX KEY:			0001709626
		STANDARD INDUSTRIAL CLASSIFICATION:	PHARMACEUTICAL PREPARATIONS [2834]
		IRS NUMBER:				000000000
		STATE OF INCORPORATION:			X0
		FISCAL YEAR END:			1231

	FILING VALUES:
		FORM TYPE:		6-K
		SEC ACT:		1934 Act
		SEC FILE NUMBER:	001-38215
		FILM NUMBER:		19894848

	BUSINESS ADDRESS:	
		STREET 1:		3 LOCHSIDE WAY
		CITY:			EDINBURGH
		STATE:			X0
		ZIP:			EH12 9DT
		BUSINESS PHONE:		44-0-131-357-1111

	MAIL ADDRESS:	
		STREET 1:		3 LOCHSIDE WAY
		CITY:			EDINBURGH
		STATE:			X0
		ZIP:			EH12 9DT

	FORMER COMPANY:	
		FORMER CONFORMED NAME:	NuCana BioMed Ltd
		DATE OF NAME CHANGE:	20170619
</SEC-HEADER>
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<TYPE>6-K
<SEQUENCE>1
<FILENAME>d765443d6k.htm
<DESCRIPTION>6-K
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<TITLE>6-K</TITLE>
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<Center><DIV STYLE="width:8.5in" align="left">
 <P STYLE="line-height:1.0pt;margin-top:0pt;margin-bottom:0pt;border-bottom:1px solid #000000">&nbsp;</P>
<P STYLE="line-height:3.0pt;margin-top:0pt;margin-bottom:2pt;border-bottom:1px solid #000000">&nbsp;</P> <P STYLE="margin-top:4pt; margin-bottom:0pt; font-size:18pt; font-family:Times New Roman" ALIGN="center"><B>UNITED STATES </B></P>
<P STYLE="margin-top:0pt; margin-bottom:0pt; font-size:18pt; font-family:Times New Roman" ALIGN="center"><B>SECURITIES AND EXCHANGE COMMISSION </B></P>
<P STYLE="margin-top:0pt; margin-bottom:0pt; font-size:12pt; font-family:Times New Roman" ALIGN="center"><B>Washington, D.C. 20549 </B></P> <P STYLE="font-size:12pt;margin-top:0pt;margin-bottom:0pt">&nbsp;</P><center>
<P STYLE="line-height:6.0pt;margin-top:0pt;margin-bottom:2pt;border-bottom:1.00pt solid #000000;width:21%">&nbsp;</P></center> <P STYLE="margin-top:12pt; margin-bottom:0pt; font-size:18pt; font-family:Times New Roman" ALIGN="center"><B><FONT
STYLE="white-space:nowrap">FORM&nbsp;6-K</FONT> </B></P> <P STYLE="font-size:12pt;margin-top:0pt;margin-bottom:0pt">&nbsp;</P><center>
<P STYLE="line-height:6.0pt;margin-top:0pt;margin-bottom:2pt;border-bottom:1.00pt solid #000000;width:21%">&nbsp;</P></center> <P STYLE="margin-top:12pt; margin-bottom:0pt; font-size:12pt; font-family:Times New Roman" ALIGN="center"><B>REPORT OF
FOREIGN ISSUER </B></P> <P STYLE="margin-top:0pt; margin-bottom:0pt; font-size:12pt; font-family:Times New Roman" ALIGN="center"><B>PURSUANT TO RULE <FONT STYLE="white-space:nowrap">13a-16</FONT> OR <FONT STYLE="white-space:nowrap">15d-16</FONT>
</B></P> <P STYLE="margin-top:0pt; margin-bottom:0pt; font-size:12pt; font-family:Times New Roman" ALIGN="center"><B>OF THE SECURITIES EXCHANGE ACT OF 1934 </B></P>
<P STYLE="margin-top:12pt; margin-bottom:0pt; font-size:10pt; font-family:Times New Roman" ALIGN="center"><B>For the month of June 2019 </B></P>
<P STYLE="margin-top:12pt; margin-bottom:0pt; font-size:10pt; font-family:Times New Roman" ALIGN="center"><B>(Commission File <FONT STYLE="white-space:nowrap">No.&nbsp;001-38215)</FONT> </B></P>
<P STYLE="font-size:12pt;margin-top:0pt;margin-bottom:0pt">&nbsp;</P><center> <P STYLE="line-height:6.0pt;margin-top:0pt;margin-bottom:2pt;border-bottom:1.00pt solid #000000;width:21%">&nbsp;</P></center>
<P STYLE="margin-top:12pt; margin-bottom:0pt; font-size:24pt; font-family:Times New Roman" ALIGN="center"><B>NUCANA PLC </B></P> <P STYLE="margin-top:0pt; margin-bottom:0pt; font-size:10pt; font-family:Times New Roman" ALIGN="center"><B>(Translation
of registrant&#146;s name into English) </B></P> <P STYLE="font-size:12pt;margin-top:0pt;margin-bottom:0pt">&nbsp;</P><center>
<P STYLE="line-height:6.0pt;margin-top:0pt;margin-bottom:2pt;border-bottom:1.00pt solid #000000;width:21%">&nbsp;</P></center> <P STYLE="margin-top:12pt; margin-bottom:0pt; font-size:10pt; font-family:Times New Roman" ALIGN="center"><B>3 Lochside
Way </B></P> <P STYLE="margin-top:0pt; margin-bottom:0pt; font-size:10pt; font-family:Times New Roman" ALIGN="center"><B>Edinburgh EH12 9DT </B></P>
<P STYLE="margin-top:0pt; margin-bottom:0pt; font-size:10pt; font-family:Times New Roman" ALIGN="center"><B>United Kingdom </B></P> <P STYLE="margin-top:0pt; margin-bottom:0pt; font-size:8pt; font-family:Times New Roman" ALIGN="center"><B>(Address
of registrant&#146;s principal executive office) </B></P> <P STYLE="font-size:12pt;margin-top:0pt;margin-bottom:0pt">&nbsp;</P><center>
<P STYLE="line-height:6.0pt;margin-top:0pt;margin-bottom:2pt;border-bottom:1.00pt solid #000000;width:21%">&nbsp;</P></center> <P STYLE="margin-top:12pt; margin-bottom:0pt; font-size:10pt; font-family:Times New Roman">Indicate by check mark whether
the registrant files or will file annual reports under cover <FONT STYLE="white-space:nowrap">Form&nbsp;20-F</FONT> or <FONT STYLE="white-space:nowrap">Form&nbsp;40-F.</FONT> </P>
<P STYLE="margin-top:12pt; margin-bottom:0pt; font-size:10pt; font-family:Times New Roman" ALIGN="center"><FONT STYLE="white-space:nowrap">Form&nbsp;20-F&nbsp;&nbsp;&#9746;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;
Form</FONT> <FONT STYLE="white-space:nowrap">40-F&nbsp;&nbsp;&#9744;</FONT> </P> <P STYLE="margin-top:12pt; margin-bottom:0pt; font-size:10pt; font-family:Times New Roman">Indicate by check mark if the registrant is submitting the <FONT
STYLE="white-space:nowrap">Form&nbsp;6-K</FONT> in paper as permitted by Regulation <FONT STYLE="white-space:nowrap">S-T</FONT> Rule&nbsp;101&nbsp;(b)&nbsp;(1):&nbsp;&nbsp;&#9744; </P>
<P STYLE="margin-top:12pt; margin-bottom:0pt; font-size:10pt; font-family:Times New Roman">Indicate by check mark if the registrant is submitting the <FONT STYLE="white-space:nowrap">Form&nbsp;6-K</FONT> in paper as permitted by Regulation <FONT
STYLE="white-space:nowrap">S-T</FONT> Rule&nbsp;101&nbsp;(b)&nbsp;(7):&nbsp;&nbsp;&#9744; </P> <P STYLE="font-size:10pt;margin-top:0pt;margin-bottom:0pt">&nbsp;</P>
<P STYLE="line-height:3.0pt;margin-top:0pt;margin-bottom:0pt;border-bottom:1px solid #000000">&nbsp;</P> <P STYLE="line-height:3.0pt;margin-top:0pt;margin-bottom:2pt;border-bottom:1px solid #000000">&nbsp;</P>
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 <P STYLE="margin-top:0pt; margin-bottom:0pt; font-size:10pt; font-family:Times New Roman"><B>Other Events </B></P>
<P STYLE="margin-top:6pt; margin-bottom:0pt; font-size:10pt; font-family:Times New Roman">On June&nbsp;12, 2019, NuCana plc (the &#147;Company&#148;) issued a press release announcing that the U.S. Food and Drug Administration has granted
orphan-drug designation for the Company&#146;s investigational drug, Acelarin<SUP STYLE="font-size:85%; vertical-align:top">&reg;</SUP> (NUC-1031), for the treatment of biliary tract cancer. The press release is attached as Exhibit 99.1 hereto and
is incorporated by reference herein. </P> <P STYLE="margin-top:12pt; margin-bottom:0pt; font-size:10pt; font-family:Times New Roman">The information in the attached Exhibit 99.1 is being furnished and shall not be deemed &#147;filed&#148; for the
purposes of Section&nbsp;18 of the Securities Exchange Act of 1934, as amended (the &#147;Exchange Act&#148;), or otherwise subject to the liabilities of that Section, nor shall it be deemed incorporated by reference in any filing made by the
Company under the Securities Act of 1933, as amended, or the Exchange Act, except as otherwise set forth herein or as shall be expressly set forth by specific reference in such a filing. </P>
<P STYLE="margin-top:18pt; margin-bottom:0pt; font-size:10pt; font-family:Times New Roman"><B>Exhibits </B></P> <P STYLE="font-size:6pt;margin-top:0pt;margin-bottom:0pt">&nbsp;</P>
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<TD VALIGN="top" NOWRAP>99.1</TD>
<TD VALIGN="bottom">&nbsp;&nbsp;</TD>
<TD VALIGN="top"><A HREF="d765443dex991.htm">Press Release, dated June&nbsp;12, 2019 </A></TD></TR>
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 <P STYLE="margin-top:0pt; margin-bottom:0pt; font-size:10pt; font-family:Times New Roman" ALIGN="center"><B><U>SIGNATURES </U></B></P>
<P STYLE="margin-top:12pt; margin-bottom:0pt; font-size:10pt; font-family:Times New Roman">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. </P> <P STYLE="font-size:12pt;margin-top:0pt;margin-bottom:0pt">&nbsp;</P><DIV ALIGN="right">
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<TD VALIGN="top" COLSPAN="3"> <P STYLE=" margin-top:0pt ; margin-bottom:0pt; margin-left:1.00em; text-indent:-1.00em; font-size:10pt; font-family:Times New Roman"><B>NuCana plc</B></P></TD></TR>
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<TD VALIGN="bottom">By:</TD>
<TD VALIGN="bottom">&nbsp;</TD>
<TD VALIGN="bottom"> <P STYLE="margin-top:0pt; margin-bottom:1pt; border-bottom:1px solid #000000; font-size:10pt; font-family:Times New Roman">/s/ Donald Munoz</P></TD></TR>
<TR STYLE="page-break-inside:avoid ; font-family:Times New Roman; font-size:10pt">
<TD VALIGN="bottom">Name:</TD>
<TD VALIGN="bottom">&nbsp;</TD>
<TD VALIGN="bottom">Donald Munoz</TD></TR>
<TR STYLE="page-break-inside:avoid ; font-family:Times New Roman; font-size:10pt">
<TD VALIGN="bottom">Title:</TD>
<TD VALIGN="bottom">&nbsp;</TD>
<TD VALIGN="bottom">Chief&nbsp;Financial&nbsp;Officer</TD></TR>
</TABLE></DIV> <P STYLE="margin-top:12pt; margin-bottom:0pt; font-size:10pt; font-family:Times New Roman">Date: June&nbsp;13, 2019 </P>
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<TYPE>EX-99.1
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<FILENAME>d765443dex991.htm
<DESCRIPTION>EX-99.1
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<Center><DIV STYLE="width:8.5in" align="left">
 <P STYLE="margin-top:0pt; margin-bottom:0pt; font-size:10pt; font-family:Times New Roman" ALIGN="right"><B>Exhibit 99.1 </B></P>
<P STYLE="margin-top:12pt; margin-bottom:0pt; font-size:10pt; font-family:Times New Roman" ALIGN="center"><B>NuCana Receives Orphan Drug Designation from the U.S. Food and Drug </B></P>
<P STYLE="margin-top:0pt; margin-bottom:0pt; font-size:10pt; font-family:Times New Roman" ALIGN="center"><B>Administration for Acelarin<SUP STYLE="font-size:85%; vertical-align:top">&reg;</SUP> for the Treatment of Biliary Tract Cancer </B></P>
<P STYLE="margin-top:12pt; margin-bottom:0pt; font-size:10pt; font-family:Times New Roman" ALIGN="center"><B><I>NuCana Remains on Track to Open Global Phase III Study in 2019 </I></B></P>
<P STYLE="margin-top:12pt; margin-bottom:0pt; font-size:10pt; font-family:Times New Roman">Edinburgh, United Kingdom, June&nbsp;12, 2019 (GLOBE NEWSWIRE) &#150; NuCana plc (NASDAQ: NCNA) today announced that the U.S. Food and Drug Administration
(FDA) has granted orphan drug designation for the Company&#146;s investigational drug, Acelarin<SUP STYLE="font-size:85%; vertical-align:top">&reg;</SUP> <FONT STYLE="white-space:nowrap">(NUC-1031),</FONT> for the treatment of biliary tract cancer.
Acelarin is a new chemical entity and is NuCana&#146;s ProTide transformation of gemcitabine. </P> <P STYLE="margin-top:12pt; margin-bottom:0pt; font-size:10pt; font-family:Times New Roman">&#147;We are pleased to have received orphan drug
designation from the FDA for Acelarin in biliary tract cancer,&#148; said Hugh Griffith, NuCana&#146;s Founder and Chief Executive Officer. &#147;There is a high unmet need for patients suffering from this cancer type. Our Phase Ib study of Acelarin
combined with cisplatin showed an approximate doubling of the response rate expected with the standard of care, gemcitabine plus cisplatin, with several patients achieving significant reductions in their tumor volume as well as further tumor
shrinkage over time. We believe Acelarin represents a potential significant advance in biliary tract cancer and we remain on track to open our global Phase III study in combination with cisplatin as a front-line treatment for patients with advanced
biliary tract cancer in 2019.&#148; </P> <P STYLE="margin-top:12pt; margin-bottom:0pt; font-size:10pt; font-family:Times New Roman">Orphan drug designation is granted by the FDA to drugs that are defined as those intended for the treatment,
prevention or diagnosis of rare diseases or conditions that affect fewer than 200,000 people in the United States. Orphan drug designation provides certain benefits and incentives that may include tax credits towards the cost of clinical trials and
prescription drug user fee waivers. </P> <P STYLE="margin-top:18pt; margin-bottom:0pt; font-size:10pt; font-family:Times New Roman"><B>About Biliary Tract Cancer </B></P>
<P STYLE="margin-top:6pt; margin-bottom:0pt; font-size:10pt; font-family:Times New Roman">Biliary tract cancer is a form of cancer that develops in the bile duct system, which connects the liver, gallbladder, and small intestine, moving bile &#150;
a fluid that helps digest fats &#150; to the small intestine. Approximately 178,000 new cases of biliary tract cancer are diagnosed each year worldwide, with more than 12,000 of those diagnoses in the United States. </P>
<P STYLE="margin-top:18pt; margin-bottom:0pt; font-size:10pt; font-family:Times New Roman"><B>About NuCana plc </B></P> <P STYLE="margin-top:6pt; margin-bottom:0pt; font-size:10pt; font-family:Times New Roman">NuCana<SUP
STYLE="font-size:85%; vertical-align:top">&reg;</SUP> is a clinical-stage biopharmaceutical company focused on significantly improving treatment outcomes for cancer patients by applying our
ProTide<SUP STYLE="font-size:85%; vertical-align:top">&#153;</SUP> technology to transform some of the most widely prescribed chemotherapy agents, nucleoside analogs, into more effective and safer medicines. While these conventional agents remain
part of the standard of care for the treatment of many solid tumors, their efficacy is limited by cancer cell resistance mechanisms and they are often poorly tolerated. Utilizing our proprietary technology, we are developing new medicines, ProTides,
designed to overcome key cancer resistance mechanisms and generate much higher concentrations of anti-cancer metabolites in cancer cells. Our most advanced ProTide candidates, Acelarin<SUP STYLE="font-size:85%; vertical-align:top">&reg;</SUP> and <FONT
STYLE="white-space:nowrap">NUC-3373,</FONT> are new chemical entities derived from the nucleoside analogs gemcitabine and <FONT STYLE="white-space:nowrap">5-fluorouracil,</FONT> respectively, two widely used chemotherapy agents. Acelarin is
currently being evaluated in three clinical studies, including a Phase Ib study for patients with biliary tract cancer, a Phase II study for patients with ovarian cancer and a Phase III study for patients with pancreatic cancer. <FONT
STYLE="white-space:nowrap">NUC-3373</FONT> is currently in a Phase I study for the potential treatment of a wide range of advanced solid tumors and a Phase Ib study for patients with advanced colorectal cancer. </P>
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 <P STYLE="margin-top:0pt; margin-bottom:0pt; font-size:10pt; font-family:Times New Roman"><B>Forward-Looking Statements </B></P>
<P STYLE="margin-top:6pt; margin-bottom:0pt; font-size:10pt; font-family:Times New Roman">This press release may contain <FONT STYLE="white-space:nowrap">&#147;forward-looking&#148;</FONT> statements within the meaning of the Private Securities
Litigation Reform Act of 1995 that are based on the beliefs and assumptions and on information currently available to management of NuCana plc (the &#147;Company&#148;). All statements other than statements of historical fact contained in this press
release are forward-looking statements, including statements concerning the Company&#146;s planned and ongoing clinical studies for the Company&#146;s product candidates and the potential advantages of those product candidates, including Acelarin, <FONT
STYLE="white-space:nowrap">NUC-3373</FONT> and <FONT STYLE="white-space:nowrap">NUC-7738;</FONT> the initiation, enrollment, timing, progress, release of data from and results of those planned and ongoing clinical studies; and the utility of prior
preclinical and clinical data in determining future clinical results. In some cases, you can identify forward-looking statements by terminology such as &#147;may,&#148; &#147;will,&#148; &#147;should,&#148; &#147;expects,&#148; &#147;plans,&#148;
&#147;anticipates,&#148; &#147;believes,&#148; &#147;estimates,&#148; &#147;predicts,&#148; &#147;potential&#148; or &#147;continue&#148; or the negative of these terms or other comparable terminology. Forward-looking statements involve known and
unknown risks, uncertainties and other factors that may cause the Company&#146;s actual results, performance or achievements to be materially different from any future results, performance or achievements expressed or implied by the forward-looking
statements. These risks and uncertainties include, but are not limited to, the risks and uncertainties set forth in the &#147;Risk Factors&#148; section of the Company&#146;s Annual Report on Form <FONT STYLE="white-space:nowrap">20-F</FONT> for the
year ended December&nbsp;31, 2018 filed with the Securities and Exchange Commission (&#147;SEC&#148;) on March&nbsp;7, 2019, and subsequent reports that the Company files with the SEC. Forward-looking statements represent the Company&#146;s beliefs
and assumptions only as of the date of this press release. Although the Company believes that the expectations reflected in the forward-looking statements are reasonable, it cannot guarantee future results, levels of activity, performance or
achievements. Except as required by law, the Company assumes no obligation to publicly update any <FONT STYLE="white-space:nowrap">forward-looking</FONT> statements for any reason after the date of this press release to conform any of the
forward-looking statements to actual results or to changes in its expectations. </P> <P STYLE="margin-top:12pt; margin-bottom:0pt; font-size:10pt; font-family:Times New Roman">For more information, please contact: </P>
<P STYLE="margin-top:12pt; margin-bottom:0pt; font-size:10pt; font-family:Times New Roman">NuCana plc </P> <P STYLE="margin-top:0pt; margin-bottom:0pt; font-size:10pt; font-family:Times New Roman">Hugh S. Griffith </P>
<P STYLE="margin-top:0pt; margin-bottom:0pt; font-size:10pt; font-family:Times New Roman">Chief Executive Officer </P> <P STYLE="margin-top:0pt; margin-bottom:0pt; font-size:10pt; font-family:Times New Roman">+44 131 357 1111 </P>
<P STYLE="margin-top:0pt; margin-bottom:0pt; font-size:10pt; font-family:Times New Roman"><U>info@nucana.com </U></P> <P STYLE="margin-top:12pt; margin-bottom:0pt; font-size:10pt; font-family:Times New Roman">Westwicke, an ICR Company </P>
<P STYLE="margin-top:0pt; margin-bottom:0pt; font-size:10pt; font-family:Times New Roman">Chris Brinzey </P> <P STYLE="margin-top:0pt; margin-bottom:0pt; font-size:10pt; font-family:Times New Roman">+1 <FONT STYLE="white-space:nowrap"><FONT
STYLE="white-space:nowrap">339-970-2843</FONT></FONT> </P> <P STYLE="margin-top:0pt; margin-bottom:0pt; font-size:10pt; font-family:Times New Roman"><U>chris.brinzey@westwicke.com </U></P>
<P STYLE="margin-top:12pt; margin-bottom:0pt; font-size:10pt; font-family:Times New Roman">RooneyPartners </P> <P STYLE="margin-top:0pt; margin-bottom:0pt; font-size:10pt; font-family:Times New Roman">Marion Janic </P>
<P STYLE="margin-top:0pt; margin-bottom:0pt; font-size:10pt; font-family:Times New Roman">+1 <FONT STYLE="white-space:nowrap"><FONT STYLE="white-space:nowrap">212-223-4017</FONT></FONT> </P>
<P STYLE="margin-top:0pt; margin-bottom:0pt; font-size:10pt; font-family:Times New Roman"><U>mjanic@rooneyco.com</U> </P>
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