<SEC-DOCUMENT>0001104659-21-000639.txt : 20210105
<SEC-HEADER>0001104659-21-000639.hdr.sgml : 20210105
<ACCEPTANCE-DATETIME>20210105090851
ACCESSION NUMBER:		0001104659-21-000639
CONFORMED SUBMISSION TYPE:	8-K
PUBLIC DOCUMENT COUNT:		3
CONFORMED PERIOD OF REPORT:	20210105
ITEM INFORMATION:		Other Events
ITEM INFORMATION:		Financial Statements and Exhibits
FILED AS OF DATE:		20210105
DATE AS OF CHANGE:		20210105

FILER:

	COMPANY DATA:	
		COMPANY CONFORMED NAME:			Millendo Therapeutics, Inc.
		CENTRAL INDEX KEY:			0001544227
		STANDARD INDUSTRIAL CLASSIFICATION:	PHARMACEUTICAL PREPARATIONS [2834]
		IRS NUMBER:				451472564
		STATE OF INCORPORATION:			DE
		FISCAL YEAR END:			1231

	FILING VALUES:
		FORM TYPE:		8-K
		SEC ACT:		1934 Act
		SEC FILE NUMBER:	001-35890
		FILM NUMBER:		21504082

	BUSINESS ADDRESS:	
		STREET 1:		110 MILLER AVENUE, SUITE 100
		CITY:			ANN ARBOR
		STATE:			MI
		ZIP:			48104
		BUSINESS PHONE:		734-845-9000

	MAIL ADDRESS:	
		STREET 1:		110 MILLER AVENUE, SUITE 100
		CITY:			ANN ARBOR
		STATE:			MI
		ZIP:			48104

	FORMER COMPANY:	
		FORMER CONFORMED NAME:	OvaScience, Inc.
		DATE OF NAME CHANGE:	20120308
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<P STYLE="margin: 0">&nbsp;</P>





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<P STYLE="font: 18pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: center"><B>UNITED STATES </B></P>

<P STYLE="font: 18pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: center"><B>SECURITIES AND EXCHANGE COMMISSION</B></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: center"><B>WASHINGTON, D.C. 20549</B></P>

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<P STYLE="font: 18pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: center"><B>FORM 8-K</B></P>

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<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: center"><B>CURRENT REPORT </B></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: center"><B>Pursuant to Section 13 or 15(d) </B></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: center"><B>of the Securities Exchange Act of 1934
</B></P>

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<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: center">Date of Report (Date of earliest event
reported): <B>January 5, 2021</B></P>

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<P STYLE="font: 18pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: center"><B>Millendo Therapeutics, Inc.</B></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: center">(Exact name of registrant as specified
in its charter) </P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: center">&#160;</P>

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Ann Arbor, Michigan</B></FONT></TD>
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<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: center">(Former name or former address, if changed
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<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; 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 (see General Instruction A.2.  below):</P>

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    <TD><FONT STYLE="font: 10pt Times New Roman, Times, Serif">Written communications pursuant
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    <TD><FONT STYLE="font: 10pt Times New Roman, Times, Serif">Pre-commencement communications pursuant to
Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))</FONT></TD></TR>
<TR STYLE="vertical-align: top">
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    <TD><FONT STYLE="font: 10pt Times New Roman, Times, Serif">Pre-commencement communications pursuant to
Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))</FONT></TD></TR>
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<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; background-color: white">&#160;</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; background-color: white">Securities registered pursuant to Section&#160;12(b)
of the Act:</P>

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<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: left">Indicate by check mark whether the registrant is an emerging
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Exchange Act of 1934 (&#167;240.12b-2 of this chapter).</P>

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<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: left">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. <FONT STYLE="font-family: Wingdings">&#168;</FONT></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0">&#160;</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0"></P>

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<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0"></P>

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<TR STYLE="vertical-align: top">
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<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; background-color: white"><B><I>&#160;</I></B></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: left; background-color: white">On January 5, 2021, the Company issued
a press release announcing an expansion of the Company&#8217;s pursuit of strategic alternatives and a discontinuation of the development
of MLE-301. A copy of the press release is attached as Exhibit 99.1 to this Current Report on Form 8-K and is incorporated herein
by reference.</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0"><B>&#160;</B></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0"><B>Item 9.01 Financial Statements and Exhibits.</B></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0">&#160;</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0">(d)&#160;&#160;&#160;&#160;Exhibits</P>

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    <TD STYLE="font: 10pt Times New Roman, Times, Serif"><A HREF="tm211614d1_ex99-1.htm"><FONT STYLE="font: 10pt Times New Roman, Times, Serif">99.1</FONT></A></TD>
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    <TD STYLE="font: 10pt Times New Roman, Times, Serif"><A HREF="tm211614d1_ex99-1.htm"><FONT STYLE="font: 10pt Times New Roman, Times, Serif">Press
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<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0">&#160;</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0"></P>

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<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: center"><B>SIGNATURE</B></P>

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<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; 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.</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: center">&#160;</P>

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    <TD STYLE="width: 3%">&#160;</TD>
    <TD STYLE="width: 47%"><FONT STYLE="font-size: 10pt">MILLENDO THERAPEUTICS,&#160;INC.</FONT></TD></TR>
<TR STYLE="vertical-align: top">
    <TD>&#160;</TD>
    <TD>&#160;</TD>
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<TR STYLE="vertical-align: top">
    <TD><FONT STYLE="font-size: 10pt">Date: January 5, 2021</FONT></TD>
    <TD><FONT STYLE="font-size: 10pt">By:</FONT></TD>
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    <TD><FONT STYLE="font-size: 10pt"><I>President and Chief Executive Officer</I></FONT></TD></TR>
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<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0">&#160;</P>

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<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0"></P>

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<DESCRIPTION>EXHIBIT 99.1
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<P STYLE="text-align: right; font: 10pt Times New Roman, Times, Serif; margin: 0pt 0"><B>Exhibit 99.1</B></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; color: Red">&nbsp;</P>

<P STYLE="text-align: center; font: 10pt Times New Roman, Times, Serif; margin-top: 0pt; margin-bottom: 0pt; color: Red"><IMG SRC="tm211614d1_ex99-1img01.jpg" ALT="">&nbsp;</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; text-align: center; margin-top: 0pt; margin-bottom: 0pt; color: Red">&nbsp;</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; color: Red"></P>

<P STYLE="font: 13pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: center"><B>Millendo Therapeutics Provides Pipeline
and Business Update</B></P>

<P STYLE="font: 13pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: center"><B>&nbsp;</B></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: center"><I>&ndash; Further investment in MLE-301,
a selective neurokinin 3 receptor (NK3R) antagonist, <BR>
not planned following initial review of data from Phase 1 clinical study &ndash;</I></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: center"><I>&nbsp;</I></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: center"><I>&ndash; Company exploring expanded range
of strategic alternatives to maximize its assets &ndash;</I></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0">&nbsp;</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0"><B>ANN ARBOR, Mich., January 5, 2021 </B>&ndash; <U>Millendo
Therapeutics, Inc</U>. (Nasdaq: MLND), announced today that its Board of Directors has decided to discontinue further investment
in MLE-301, a selective neurokinin 3 receptor (NK3R) antagonist for the treatment of menopausal vasomotor symptoms (VMS), based
on an analysis of the pharmacokinetic and pharmacodynamic data from the ongoing single ascending dose portion of the Phase 1 study
being conducted in healthy male volunteers. While MLE-301 was generally well-tolerated, the data do not support moving forward
with its development in the target population of peri- and post-menopausal women, especially with the evolving dynamics of a highly
competitive NK3R antagonist market.</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0">&nbsp;</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0">Given the Company&rsquo;s limited expected financing options,
Millendo&rsquo;s Board of Directors has determined that it is in the best interests of the Company&rsquo;s shareholders to explore
an expanded range of strategic alternatives that include, but are not limited to, the potential sale or merger of the Company or
its assets. Millendo will continue working with SVB Leerink to assist in its ongoing strategic process.</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0">&nbsp;</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0">Carol Gallagher, Chairman of the Board, commented, &quot;We
would like to acknowledge and thank all of our employees for their hard work in supporting Millendo&rsquo;s mission of pursuing
novel therapies to alleviate patient suffering due to endocrine diseases. The Board has continued to support the Company&rsquo;s
ongoing plans and execution efforts; however, at this time the Board believes that it is in the best interest of the Company and
its shareholders to actively seek a broad range of strategic alternatives, including a sale or merger of the Company in order to
maximize shareholder value.&rdquo;</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0">&nbsp;</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0">To conserve cash, Millendo intends to review its operating costs
and may plan for a reduction in its workforce in order to focus its resources on essential business activities.</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0">&nbsp;</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0"></P>

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<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0">&nbsp;</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0">No assurance can be given regarding the outcome or timing of
the strategic review process. Millendo does not intend to discuss or disclose further developments regarding the strategic review
process unless and until its Board of Directors has approved a specific action or otherwise determined that further disclosure
is appropriate or required by law.</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0">&nbsp;</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0"><B>About MLE-301<BR>
</B>MLE-301 is a neurokinin 3 receptor (NK3R) antagonist that Millendo was developing as a potential treatment of VMS, commonly
known as hot flashes and night sweats, in menopausal women. NK3R plays a key role in regulating the activity of KNDy (kisspeptin/NKB/dynorphin)
neurons, which has been shown to participate in the generation of VMS.</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0">&nbsp;</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0"><B>About Millendo Therapeutics, Inc. &nbsp;<BR>
</B>Millendo Therapeutics&nbsp;is a clinical-stage biopharmaceutical company primarily focused on developing novel treatments
for endocrine diseases where current therapies do not exist or are insufficient. Millendo seeks to create distinct and transformative
treatments where there is a significant unmet medical need. For more information, please visit <U>www.millendo.com</U>.</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0">&nbsp;</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0"><B><I>Cautionary Statement Regarding Forward-Looking Statements</I></B></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; background-color: white">Certain statements contained in this
press release regarding matters that are not historical facts, are forward-looking statements 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. In some cases, you
can identify forward-looking statements by the words &ldquo;may,&rdquo; &ldquo;might,&rdquo; &ldquo;will,&rdquo; &ldquo;could,&rdquo;
 &ldquo;would,&rdquo; &ldquo;should,&rdquo; &ldquo;expect,&rdquo; &ldquo;intend,&rdquo; &ldquo;plan,&rdquo; &ldquo;objective,&rdquo;
 &ldquo;anticipate,&rdquo; &ldquo;believe,&rdquo; &ldquo;estimate,&rdquo; &ldquo;predict,&rdquo; &ldquo;project,&rdquo; &ldquo;potential,&rdquo;
 &ldquo;continue&rdquo; and &ldquo;ongoing,&rdquo; or the negative of these terms, or other comparable terminology intended to identify
statements about the future. These include statements with respect to the company&rsquo;s plan to cease investing in MLE-301 and
its ongoing strategic review process, and, therefore, you are cautioned not to place undue reliance on them. Such forward-looking
statements are based on Millendo&rsquo;s expectations and involve risks and uncertainties; consequently, actual results may differ
materially from those expressed or implied in the statements due to a number of factors, including that Millendo has incurred significant
losses since inception, Millendo has a limited operating history and has never generated any revenue from product sales, Millendo
will require additional capital to finance its operations, Millendo's future success is dependent on the successful clinical development,
regulatory approval and subsequent commercialization of current and any future product candidates, preclinical studies or earlier
clinical trials are not necessarily predictive of future results and the results of Millendo's clinical trials may not support
Millendo's product candidate claims, Millendo may encounter substantial delays in its clinical trials or Millendo may fail to demonstrate
safety and efficacy to the satisfaction of applicable regulatory authorities, enrollment and retention of patients in clinical
trials is an expensive and time-consuming process and could be made more difficult or rendered impossible by multiple factors outside
Millendo's control, Millendo's product candidates may cause undesirable side effects or have other properties that could delay
or prevent their regulatory approval, or limit their commercial potential, Millendo faces substantial competition and Millendo&rsquo;s
business, preclinical studies and clinical development programs and timelines, its financial condition and results of operations
could be materially and adversely affected by the current COVID-19 pandemic. You should refer to the risk factor disclosure set
forth in the periodic reports and other documents Millendo files with the&nbsp;Securities and Exchange Commission&nbsp;available
at&nbsp;www.sec.gov, including without limitation Millendo&rsquo;s Quarterly Report on Form 10-Q for the fiscal quarter ended September
30, 2020.</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; background-color: white">&nbsp;</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; background-color: white"></P>

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<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; background-color: white">&nbsp;</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">New
factors emerge from time to time and it is not possible for Millendo to predict all such factors, nor can Millendo assess the
impact of each such factor on the business or the extent to which any factor, or combination of factors, may cause actual results
to differ materially from those contained in any forward-looking statements. Forward-looking statements included in this press
release are based on information available to Millendo as of the date of this press release. Millendo disclaims any obligation
to update such forward-looking statements to reflect events or circumstances after the date of this press release, except as required
by applicable law.</FONT></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0"><B>&nbsp;</B></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0"><B>Millendo Investor Contact:</B><BR>
Jack Hildick-Smith</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0">Stern Investor Relations<BR>
914-610-6811</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0"><U>Jack.Hildick-Smith@Sternir.com</U></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0">&nbsp;<BR>
<B>Millendo Media Contact:</B><BR>
Julie Bane<BR>
MacDougall<BR>
617-821-1089<BR>
<U>jbane@macbiocom.com</U></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: center">&nbsp;</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: center">###</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: center">&nbsp;</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: center"></P>

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<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: center">&nbsp;</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0">&nbsp;</P>

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