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 <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>FORM <FONT
STYLE="white-space:nowrap">8-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>CURRENT
REPORT </B></P> <P STYLE="margin-top:0pt; margin-bottom:0pt; font-size:12pt; font-family:Times New Roman" ALIGN="center"><B>Pursuant to Section&nbsp;13 or 15(d) </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:12pt; font-family:Times New Roman" ALIGN="center"><B>Date of Report (Date of earliest event reported): January&nbsp;4, 2019 </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>Regulus Therapeutics Inc. </B></P>
<P STYLE="margin-top:0pt; margin-bottom:0pt; font-size:10pt; font-family:Times New Roman" ALIGN="center"><B>(Exact name of registrant as specified in its charter) </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="font-size:12pt;margin-top:0pt;margin-bottom:0pt">&nbsp;</P>
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<TD VALIGN="top" ALIGN="center"><B>Delaware</B></TD>
<TD VALIGN="bottom">&nbsp;</TD>
<TD VALIGN="top" ALIGN="center"><B><FONT STYLE="white-space:nowrap">001-35670</FONT></B></TD>
<TD VALIGN="bottom">&nbsp;</TD>
<TD VALIGN="top" ALIGN="center"><B><FONT STYLE="white-space:nowrap">26-4738379</FONT></B></TD></TR>
<TR STYLE="page-break-inside:avoid ; font-family:Times New Roman; font-size:8pt">
<TD VALIGN="top" ALIGN="center"><B>(State of incorporation)</B></TD>
<TD VALIGN="bottom">&nbsp;</TD>
<TD VALIGN="top" ALIGN="center"> <P STYLE="margin-top:0pt; margin-bottom:0pt; font-size:8pt; font-family:Times New Roman" ALIGN="center"><B>(Commission</B></P>
<P STYLE="margin-top:0pt; margin-bottom:1pt; font-size:8pt; font-family:Times New Roman" ALIGN="center"><B>File No.)</B></P></TD>
<TD VALIGN="bottom">&nbsp;</TD>
<TD VALIGN="top" ALIGN="center"> <P STYLE="margin-top:0pt; margin-bottom:0pt; font-size:8pt; font-family:Times New Roman" ALIGN="center"><B>(IRS Employer</B></P>
<P STYLE="margin-top:0pt; margin-bottom:1pt; font-size:8pt; font-family:Times New Roman" ALIGN="center"><B>Identification No.)</B></P></TD></TR>
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<TD HEIGHT="16" COLSPAN="2"></TD></TR>
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<TD VALIGN="top" COLSPAN="3" ALIGN="center"> <P STYLE="margin-top:0pt; margin-bottom:0pt; font-size:10pt; font-family:Times New Roman" ALIGN="center"><B>10614 Science Center Drive</B></P>
<P STYLE="margin-top:0pt; margin-bottom:1pt; font-size:10pt; font-family:Times New Roman" ALIGN="center"><B>San Diego, CA</B></P></TD>
<TD VALIGN="bottom">&nbsp;</TD>
<TD VALIGN="bottom" ALIGN="center"><B>92121</B></TD></TR>
<TR STYLE="page-break-inside:avoid ; font-family:Times New Roman; font-size:8pt">
<TD VALIGN="top" COLSPAN="3" ALIGN="center"><B>(Address of principal executive offices)</B></TD>
<TD VALIGN="bottom">&nbsp;</TD>
<TD VALIGN="top" ALIGN="center"><B>(Zip Code)</B></TD></TR>
</TABLE> <P STYLE="margin-top:12pt; margin-bottom:0pt; font-size:10pt; font-family:Times New Roman" ALIGN="center"><B>Registrant&#146;s telephone number, including area code: (858)
<FONT STYLE="white-space:nowrap">202-6300</FONT> </B></P> <P STYLE="margin-top:12pt; margin-bottom:0pt; font-size:10pt; font-family:Times New Roman" ALIGN="center"><B>N/A </B></P>
<P STYLE="margin-top:0pt; margin-bottom:0pt; font-size:8pt; font-family:Times New Roman" ALIGN="center"><B>(Former name or former address, if changed since last report.) </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">Check the appropriate box below if the Form <FONT STYLE="white-space:nowrap">8-K</FONT> filing is intended to simultaneously satisfy the filing obligation of
the registrant under any of the following provisions (see General Instruction A.2. below): </P> <P STYLE="font-size:6pt;margin-top:0pt;margin-bottom:0pt">&nbsp;</P>
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<TD WIDTH="4%" VALIGN="top" ALIGN="left">&#9744;</TD>
<TD ALIGN="left" VALIGN="top"> <P STYLE=" margin-top:0pt ; margin-bottom:0pt; font-size:10pt; font-family:Times New Roman; " ALIGN="left">Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425) </P></TD></TR></TABLE>
<P STYLE="font-size:6pt;margin-top:0pt;margin-bottom:0pt">&nbsp;</P>
<TABLE STYLE="BORDER-COLLAPSE:COLLAPSE; font-family:Times New Roman; font-size:10pt" BORDER="0" CELLPADDING="0" CELLSPACING="0" WIDTH="100%">
<TR style = "page-break-inside:avoid">
<TD WIDTH="4%" VALIGN="top" ALIGN="left">&#9744;</TD>
<TD ALIGN="left" VALIGN="top"> <P STYLE=" margin-top:0pt ; margin-bottom:0pt; font-size:10pt; font-family:Times New Roman; " ALIGN="left">Soliciting material pursuant to Rule <FONT STYLE="white-space:nowrap">14a-12</FONT> under the Exchange Act (17
CFR <FONT STYLE="white-space:nowrap">240.14a-12)</FONT> </P></TD></TR></TABLE> <P STYLE="font-size:6pt;margin-top:0pt;margin-bottom:0pt">&nbsp;</P>
<TABLE STYLE="BORDER-COLLAPSE:COLLAPSE; font-family:Times New Roman; font-size:10pt" BORDER="0" CELLPADDING="0" CELLSPACING="0" WIDTH="100%">
<TR style = "page-break-inside:avoid">
<TD WIDTH="4%" VALIGN="top" ALIGN="left">&#9744;</TD>
<TD ALIGN="left" VALIGN="top"> <P STYLE=" margin-top:0pt ; margin-bottom:0pt; font-size:10pt; font-family:Times New Roman; " ALIGN="left"><FONT STYLE="white-space:nowrap">Pre-commencement</FONT> communications pursuant to Rule <FONT
STYLE="white-space:nowrap">14d-2(b)</FONT> under the Exchange Act (17 CFR <FONT STYLE="white-space:nowrap">240.14d-2(b))</FONT> </P></TD></TR></TABLE> <P STYLE="font-size:6pt;margin-top:0pt;margin-bottom:0pt">&nbsp;</P>
<TABLE STYLE="BORDER-COLLAPSE:COLLAPSE; font-family:Times New Roman; font-size:10pt" BORDER="0" CELLPADDING="0" CELLSPACING="0" WIDTH="100%">
<TR style = "page-break-inside:avoid">
<TD WIDTH="4%" VALIGN="top" ALIGN="left">&#9744;</TD>
<TD ALIGN="left" VALIGN="top"> <P STYLE=" margin-top:0pt ; margin-bottom:0pt; font-size:10pt; font-family:Times New Roman; " ALIGN="left"><FONT STYLE="white-space:nowrap">Pre-commencement</FONT> communications pursuant to Rule <FONT
STYLE="white-space:nowrap">13e-4(c)</FONT> under the Exchange Act (17 CFR <FONT STYLE="white-space:nowrap">240.13e-4(c))</FONT> </P></TD></TR></TABLE>
<P STYLE="margin-top:12pt; margin-bottom:0pt; font-size:10pt; font-family:Times New Roman">Indicate by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (&#167;230.405 of this
chapter) or <FONT STYLE="white-space:nowrap">Rule&nbsp;12b-2</FONT> of the Securities Exchange Act of 1934 <FONT STYLE="white-space:nowrap">(&#167;240.12b-2</FONT> of this chapter). </P>
<P STYLE="margin-top:6pt; margin-bottom:0pt; font-size:10pt; font-family:Times New Roman">Emerging growth company&nbsp;&nbsp;&#9744; </P> <P STYLE="margin-top:12pt; margin-bottom:0pt; font-size:10pt; font-family:Times New Roman">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&nbsp;13(a) of the Exchange
Act.&nbsp;&nbsp;&#9744; </P> <P STYLE="font-size:10pt;margin-top:0pt;margin-bottom:0pt">&nbsp;</P> <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>
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 <P STYLE="margin-top:0pt; margin-bottom:0pt; font-size:10pt; font-family:Times New Roman"><B>Item&nbsp;8.01 Other Events. </B></P>
<P STYLE="margin-top:6pt; margin-bottom:0pt; font-size:10pt; font-family:Times New Roman">On January&nbsp;4, 2019, Regulus Therapeutics Inc. (the &#147;Company&#148;) announced the preliminary results of a planned interim data analysis from the new
mouse chronic toxicity study of RGLS4326 in development for the treatment of Autosomal Dominant Polycystic Kidney Disease (&#147;ADPKD&#148;). </P> <P STYLE="margin-top:12pt; margin-bottom:0pt; font-size:10pt; font-family:Times New Roman">As
previously reported by the Company in July 2018, and in consultation with the U.S. Food and Drug Administration (&#147;FDA&#148;), the Company voluntarily paused its ongoing Phase 1 Multiple Ascending Dose (&#147;MAD&#148;) study of RGLS4326 in
healthy volunteers due to unexpected observations in the <FONT STYLE="white-space:nowrap">27-week</FONT> mouse chronic toxicity study. The Company terminated that mouse study prematurely at week&nbsp;14. The study was run in parallel to the Phase 1
program to enable initiation of the Phase 2 program in ADPKD patients upon completion of the Phase 1 MAD study. The observations from the mouse chronic toxicity study were unexpected given the favorable safety profile of RGLS4326 in previous <FONT
STYLE="white-space:nowrap">7-week</FONT> <FONT STYLE="white-space:nowrap">non-GLP</FONT> and GLP toxicity studies in both mice and <FONT STYLE="white-space:nowrap">non-human</FONT> primates required for Phase&nbsp;1 testing, which had no significant
findings across similar dose levels and frequencies. Based upon the Company&#146;s investigation and the results announced today, the Company believes the unexpected observations from the previously terminated study were likely a result of technical
issues at the contract research organization (&#147;CRO&#148;). </P> <P STYLE="margin-top:12pt; margin-bottom:0pt; font-size:10pt; font-family:Times New Roman">In September 2018, the Company announced the initiation of a new <FONT
STYLE="white-space:nowrap">27-week</FONT> mouse chronic toxicity study, incorporating several changes intended to address the unexpected observations in the previous mouse chronic toxicity study. Certain key changes included the use of a different
CRO to conduct the study and the use of a new batch of RGLS4326. </P> <P STYLE="margin-top:12pt; margin-bottom:0pt; font-size:10pt; font-family:Times New Roman">The planned interim analysis of this study after
<FONT STYLE="white-space:nowrap">13-weeks</FONT> of dosing has shown no adverse or other significant findings across the range of doses tested and is intended to support <FONT STYLE="white-space:nowrap">re-initiation</FONT> of the Phase 1 MAD study
after consultation with FDA. RGLS4326 has also been generally well-tolerated in the Phase 1 Single Ascending Dose (&#147;SAD&#148;) and MAD studies in human subjects to date. </P>
<P STYLE="margin-top:12pt; margin-bottom:0pt; font-size:10pt; font-family:Times New Roman">The Company plans to submit a comprehensive data package for RGLS4326 to FDA that will include the results from the planned
<FONT STYLE="white-space:nowrap">13-week</FONT> interim analysis of the ongoing repeat mouse chronic toxicity study, as well as results from additional investigations, analytical testing, additional data from the previously terminated mouse chronic
toxicity study, data from the completed Phase&nbsp;1 SAD study and data from the first cohort of the Phase&nbsp;1 MAD study. The Company anticipates engagement with FDA in the coming weeks to discuss the resolution of the voluntary pause in human
dosing and the plan to resume the Phase 1 MAD study. </P> <P STYLE="margin-top:18pt; 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">Statements contained in this report regarding matters that are not historical facts are &#147;forward-looking statements&#148; within the meaning of the
Private Securities Litigation Reform Act of 1995, including statements associated with the expected ability of the Company to undertake certain activities and accomplish certain goals (including with respect to development and other activities
related to RGLS4326 and its ability to recommence human clinical trials), the projected timeline of clinical development activities, the anticipated engagement with FDA regarding the Company&#146;s RGLS4326 program and the timing thereof, and
expectations regarding future therapeutic and commercial potential of the Company&#146;s business plans, technologies and intellectual property related to microRNA therapeutics and biomarkers being discovered and developed by the
Company.&nbsp;Because such statements are subject to risks and uncertainties, actual results may differ materially from those expressed or implied by such forward-looking </P>
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statements. Words such as &#147;believes,&#148; &#147;anticipates,&#148; &#147;plans,&#148; &#147;expects,&#148; &#147;intends,&#148; &#147;will,&#148; &#147;goal,&#148; &#147;potential&#148; and
similar expressions are intended to identify forward-looking statements. These forward-looking statements are based upon the Company&#146;s current expectations and involve assumptions that may never materialize or may prove to be
incorrect.&nbsp;Actual results and the timing of events could differ materially from those anticipated in such forward-looking statements as a result of various risks and uncertainties, which include, without limitation, risks associated with the
current shutdown of the U.S. Government, which may delay or otherwise inhibit the Company&#146;s ability to engage with FDA on matters relating to RGLS4326; and risks associated with the process of discovering, developing and commercializing drugs
that are safe and effective for use as human therapeutics, and in the endeavor of building a business around such drugs.&nbsp;These and other risks concerning the Company&#146;s financial position and programs are described in additional detail in
the Company&#146;s filings with the Securities and Exchange Commission.&nbsp;All forward-looking statements contained in this report speak only as of the date on which they were made. The Company undertakes no obligation to update such statements to
reflect events that occur or circumstances that exist after the date on which they were made. </P>
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 <P STYLE="margin-top:0pt; margin-bottom:0pt; font-size:10pt; font-family:Times New Roman" ALIGN="center"><B>SIGNATURES </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
hereunto duly authorized. </P> <P STYLE="font-size:12pt;margin-top:0pt;margin-bottom:0pt">&nbsp;</P>
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<TD VALIGN="top" COLSPAN="3">Regulus Therapeutics Inc.</TD></TR>
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<TD VALIGN="top">Dated: January&nbsp;4, 2019</TD>
<TD VALIGN="bottom">&nbsp;</TD>
<TD VALIGN="top"></TD>
<TD VALIGN="bottom">&nbsp;</TD>
<TD VALIGN="top">By:</TD>
<TD VALIGN="bottom" STYLE=" BORDER-BOTTOM:1px solid #000000">&nbsp;</TD>
<TD VALIGN="top" STYLE="BORDER-BOTTOM:1px solid #000000">/s/ Joseph P. Hagan</TD></TR>
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<TD VALIGN="top">Joseph P. Hagan</TD></TR>
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<TD VALIGN="top"></TD>
<TD VALIGN="bottom">&nbsp;</TD>
<TD VALIGN="bottom"></TD>
<TD VALIGN="bottom">&nbsp;</TD>
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<TD VALIGN="bottom">President and Chief Executive Officer</TD></TR>
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Form 8-K
UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
WASHINGTON, D.C. 20549
FORM
8-K
CURRENT
REPORT
Pursuant to Section 13 or 15(d)
of the Securities Exchange Act of 1934
Date of Report (Date of earliest event reported): January 4, 2019
Regulus Therapeutics Inc.
(Exact name of registrant as specified in its charter)
Delaware
001-35670
26-4738379
(State of incorporation)
(Commission
File No.)
(IRS Employer
Identification No.)
10614 Science Center Drive
San Diego, CA
92121
(Address of principal executive offices)
(Zip Code)
Registrant's telephone number, including area code: (858)
202-6300
N/A
(Former name or former address, if changed since last report.)
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 (see General Instruction A.2. below):
☐
Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)
☐
Soliciting material pursuant to Rule
14a-12
under the Exchange Act (17
CFR
240.14a-12)
☐
Pre-commencement
communications pursuant to Rule
14d-2(b)
under the Exchange Act (17 CFR
240.14d-2(b))
☐
Pre-commencement
communications pursuant to Rule
13e-4(c)
under the Exchange Act (17 CFR
240.13e-4(c))
Indicate by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (§230.405 of this
chapter) or
Rule 12b-2
of the Securities Exchange Act of 1934
(§240.12b-2
of this chapter).
Emerging growth company  ☐
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.  ☐
Item 8.01 Other Events.
On January 4, 2019, Regulus Therapeutics Inc. (the "Company") announced the preliminary results of a planned interim data analysis from the new
mouse chronic toxicity study of RGLS4326 in development for the treatment of Autosomal Dominant Polycystic Kidney Disease ("ADPKD").
As
previously reported by the Company in July 2018, and in consultation with the U.S. Food and Drug Administration ("FDA"), the Company voluntarily paused its ongoing Phase 1 Multiple Ascending Dose ("MAD") study of RGLS4326 in
healthy volunteers due to unexpected observations in the
27-week
mouse chronic toxicity study. The Company terminated that mouse study prematurely at week 14. The study was run in parallel to the Phase 1
program to enable initiation of the Phase 2 program in ADPKD patients upon completion of the Phase 1 MAD study. The observations from the mouse chronic toxicity study were unexpected given the favorable safety profile of RGLS4326 in previous
7-week
non-GLP
and GLP toxicity studies in both mice and
non-human
primates required for Phase 1 testing, which had no significant
findings across similar dose levels and frequencies. Based upon the Company's investigation and the results announced today, the Company believes the unexpected observations from the previously terminated study were likely a result of technical
issues at the contract research organization ("CRO").
In September 2018, the Company announced the initiation of a new
27-week
mouse chronic toxicity study, incorporating several changes intended to address the unexpected observations in the previous mouse chronic toxicity study. Certain key changes included the use of a different
CRO to conduct the study and the use of a new batch of RGLS4326.
The planned interim analysis of this study after
13-weeks
of dosing has shown no adverse or other significant findings across the range of doses tested and is intended to support
re-initiation
of the Phase 1 MAD study
after consultation with FDA. RGLS4326 has also been generally well-tolerated in the Phase 1 Single Ascending Dose ("SAD") and MAD studies in human subjects to date.
The Company plans to submit a comprehensive data package for RGLS4326 to FDA that will include the results from the planned
13-week
interim analysis of the ongoing repeat mouse chronic toxicity study, as well as results from additional investigations, analytical testing, additional data from the previously terminated mouse chronic
toxicity study, data from the completed Phase 1 SAD study and data from the first cohort of the Phase 1 MAD study. The Company anticipates engagement with FDA in the coming weeks to discuss the resolution of the voluntary pause in human
dosing and the plan to resume the Phase 1 MAD study.
Forward-Looking Statements
Statements contained in this report regarding matters that are not historical facts are "forward-looking statements" within the meaning of the
Private Securities Litigation Reform Act of 1995, including statements associated with the expected ability of the Company to undertake certain activities and accomplish certain goals (including with respect to development and other activities
related to RGLS4326 and its ability to recommence human clinical trials), the projected timeline of clinical development activities, the anticipated engagement with FDA regarding the Company's RGLS4326 program and the timing thereof, and
expectations regarding future therapeutic and commercial potential of the Company's business plans, technologies and intellectual property related to microRNA therapeutics and biomarkers being discovered and developed by the
Company. Because such statements are subject to risks and uncertainties, actual results may differ materially from those expressed or implied by such forward-looking
statements. Words such as "believes," "anticipates," "plans," "expects," "intends," "will," "goal," "potential" and
similar expressions are intended to identify forward-looking statements. These forward-looking statements are based upon the Company's current expectations and involve assumptions that may never materialize or may prove to be
incorrect. Actual results and the timing of events could differ materially from those anticipated in such forward-looking statements as a result of various risks and uncertainties, which include, without limitation, risks associated with the
current shutdown of the U.S. Government, which may delay or otherwise inhibit the Company's ability to engage with FDA on matters relating to RGLS4326; and risks associated with the process of discovering, developing and commercializing drugs
that are safe and effective for use as human therapeutics, and in the endeavor of building a business around such drugs. These and other risks concerning the Company's financial position and programs are described in additional detail in
the Company's filings with the Securities and Exchange Commission. All forward-looking statements contained in this report speak only as of the date on which they were made. The Company undertakes no obligation to update such statements to
reflect events that occur or circumstances that exist after the date on which they were made.
SIGNATURES
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.
Regulus Therapeutics Inc.
Dated: January 4, 2019
By:
/s/ Joseph P. Hagan
Joseph P. Hagan
President and Chief Executive Officer