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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>SPERO 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">001-38266</FONT></B></TD>
<TD VALIGN="bottom">&nbsp;</TD>
<TD VALIGN="top" ALIGN="center"><B><FONT STYLE="white-space:nowrap">46-4590683</FONT></B></TD></TR>
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<TD VALIGN="top" ALIGN="center"> <P STYLE="margin-top:0pt; margin-bottom:0pt; font-size:8pt; font-family:Times New Roman" ALIGN="center"><B>(State or other jurisdiction</B></P>
<P STYLE="margin-top:0pt; margin-bottom:1pt; font-size:8pt; font-family:Times New Roman" ALIGN="center"><B>of incorporation)</B></P></TD>
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<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 Number)</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>
</TABLE> <P STYLE="margin-top:12pt; margin-bottom:0pt; font-size:10pt; font-family:Times New Roman" ALIGN="center"><B>675 Massachusetts Avenue, 14th Floor </B></P>
<P STYLE="margin-top:0pt; margin-bottom:0pt; font-size:10pt; font-family:Times New Roman" ALIGN="center"><B>Cambridge, Massachusetts 02139 </B></P>
<P STYLE="margin-top:0pt; margin-bottom:0pt; font-size:8pt; font-family:Times New Roman" ALIGN="center"><B>(Address of principal executive offices and zip code) </B></P>
<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: (857) <FONT STYLE="white-space:nowrap">242-1600</FONT> </B></P>
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<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: </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>
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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">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>
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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"><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>
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<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 (17 CFR &#167;230.405) or
Rule <FONT STYLE="white-space:nowrap">12b-2</FONT> of the Securities Exchange Act of 1934 (17 CFR <FONT STYLE="white-space:nowrap">&#167;240.12b-2).</FONT> </P>
<P STYLE="margin-top:12pt; margin-bottom:0pt; font-size:10pt; font-family:Times New Roman">Emerging growth company&nbsp;&nbsp;&#9746; </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;&#9746; </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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<TD WIDTH="10%" VALIGN="top" ALIGN="left"><B>Item&nbsp;1.01</B></TD>
<TD ALIGN="left" VALIGN="top"> <P STYLE=" margin-top:0pt ; margin-bottom:0pt; font-size:10pt; font-family:Times New Roman; " ALIGN="left"><B>Entry into a Material Definitive Agreement. </B></P></TD></TR></TABLE>
<P STYLE="margin-top:6pt; margin-bottom:0pt; text-indent:4%; font-size:10pt; font-family:Times New Roman">On January&nbsp;4, 2019, Spero Therapeutics, Inc. (&#147;Spero&#148;), through its wholly owned subsidiary New Pharma License Holdings Limited
(&#147;NPLH&#148;), entered into a license agreement (the &#147;License Agreement&#148;) with Everest Medicines II Limited (&#147;Everest&#148;), which License Agreement also includes an option granted by Spero&#146;s wholly owned subsidiary Spero
Potentiator, Inc., a Delaware corporation (&#147;Potentiator&#148; and, together with NPLH, the &#147;Company&#148;). Under the terms of the License Agreement, the Company granted Everest an exclusive license to develop, manufacture and
commercialize Spero&#146;s product candidate SPR206 (the &#147;Compound&#148;) or products that contain the Compound (a &#147;Licensed Product&#148;) in Greater China (which includes Mainland China, Hong Kong and Macau), South Korea and certain
Southeast Asian countries (collectively, the &#147;Territory&#148;). The Company retains development, manufacturing and commercialization rights with respect to the Compound and Licensed Products in the rest of the world and also retains the right
to develop or manufacture the Compound and Licensed Products in the Territory for use outside the Territory. In addition to the license grant to SPR206, the Company also granted Everest a <FONT STYLE="white-space:nowrap">12-month</FONT> exclusive
option to negotiate with the Company for an exclusive license to develop, manufacture and commercialize Spero&#146;s product candidate SPR741 in the Territory. </P>
<P STYLE="margin-top:12pt; margin-bottom:0pt; text-indent:4%; font-size:10pt; font-family:Times New Roman">Under the terms of the License Agreement, the Company is entitled to receive an upfront payment of $3&nbsp;million. The Company may also
receive up to an additional $59.5&nbsp;million in milestone payments upon Everest&#146;s achievement of certain developmental, regulatory and sales milestone events related to SPR206, which achievement cannot be guaranteed.&nbsp;The Company is also
entitled to receive high single-digit to low double-digit royalties on net sales, if any, of Licensed Products in the Territory following regulatory approval of the Compound. Everest has the right to sublicense to affiliates and third parties in the
Territory. </P> <P STYLE="margin-top:12pt; margin-bottom:0pt; text-indent:4%; font-size:10pt; font-family:Times New Roman">Everest is responsible for all costs related to developing, obtaining regulatory approval of and commercializing the Compound
and Licensed Products in the Territory, and is obligated to use commercially reasonable efforts to develop, manufacture and commercialize Licensed Products, including to achieve certain specified diligence milestones within agreed-upon periods. A
joint development committee will be established between the Company and Everest to coordinate and review the development, manufacturing and commercialization plans with respect to Licensed Products in the Territory. </P>
<P STYLE="margin-top:12pt; margin-bottom:0pt; text-indent:4%; font-size:10pt; font-family:Times New Roman">Unless earlier terminated due to certain material breaches of the contract, or otherwise, the License Agreement will expire on a <FONT
STYLE="white-space:nowrap"><FONT STYLE="white-space:nowrap">jurisdiction-by-jurisdiction</FONT></FONT> and Licensed <FONT STYLE="white-space:nowrap"><FONT STYLE="white-space:nowrap">Product-by-Licensed</FONT></FONT> Product basis until the latest to
occur of expiration of the last valid claim under a licensed patent in such jurisdiction, the expiration of regulatory exclusivity in such jurisdiction or ten years after the first commercial sale of such Licensed Product in such jurisdiction. The
License Agreement may be terminated in its entirety by Everest upon 90 or 180 days&#146; prior written notice, depending on the stage of development of the initial Licensed Product.</P>
<P STYLE="margin-top:12pt; margin-bottom:0pt; text-indent:4%; font-size:10pt; font-family:Times New Roman">The foregoing description of the terms of the License Agreement does not purport to be complete and is qualified in its entirety by reference
to the License Agreement, which Spero intends to file as an exhibit to its Quarterly Report on <FONT STYLE="white-space:nowrap">Form&nbsp;10-Q</FONT> for the quarterly period ending March&nbsp;31, 2019. Spero intends to seek confidential treatment
for certain portions of the License Agreement pursuant to a Confidential Treatment Request to be submitted to the Securities and Exchange Commission pursuant to <FONT STYLE="white-space:nowrap">Rule&nbsp;24b-2&nbsp;under</FONT> the Securities
Exchange Act of 1934, as amended. </P> <P STYLE="margin-top:12pt; margin-bottom:0pt; text-indent:4%; font-size:10pt; font-family:Times New Roman">On January&nbsp;7, 2019, Spero issued a press release announcing the entry into the License Agreement,
a copy of which is filed herewith as Exhibit&nbsp;99.1 and incorporated by reference herein. </P> <P STYLE="font-size:18pt;margin-top:0pt;margin-bottom:0pt">&nbsp;</P>
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<TD WIDTH="10%" VALIGN="top" ALIGN="left"><B>Item&nbsp;8.01</B></TD>
<TD ALIGN="left" VALIGN="top"> <P STYLE=" margin-top:0pt ; margin-bottom:0pt; font-size:10pt; font-family:Times New Roman; " ALIGN="left"><B>Other Events. </B></P></TD></TR></TABLE>
<P STYLE="margin-top:6pt; margin-bottom:0pt; text-indent:4%; font-size:10pt; font-family:Times New Roman">On January&nbsp;7, 2019, Spero issued a press release providing regulatory and clinical updates for its product candidate SPR994, a copy of
which is filed herewith as Exhibit 99.2 and is incorporated herein by reference. </P>
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<TD ALIGN="left" VALIGN="top"> <P STYLE=" margin-top:0pt ; margin-bottom:0pt; font-size:10pt; font-family:Times New Roman; " ALIGN="left"><B>Financial Statements and Exhibits. </B></P></TD></TR></TABLE>
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<TD WIDTH="4%" VALIGN="top" ALIGN="left">(d)</TD>
<TD ALIGN="left" VALIGN="top"> <P STYLE=" margin-top:0pt ; margin-bottom:0pt; font-size:10pt; font-family:Times New Roman; " ALIGN="left">Exhibits </P></TD></TR></TABLE> <P STYLE="font-size:6pt;margin-top:0pt;margin-bottom:0pt">&nbsp;</P>
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<TD VALIGN="top" NOWRAP>Exhibit&nbsp;99.1</TD>
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<TD VALIGN="top"><A HREF="d685603dex991.htm">Press Release, dated January&nbsp;7, 2019. </A></TD></TR>
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<TD VALIGN="top" NOWRAP>Exhibit&nbsp;99.2</TD>
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<TD VALIGN="top"><A HREF="d685603dex992.htm">Press Release, dated January&nbsp;7, 2019. </A></TD></TR>
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<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"><B>SPERO THERAPEUTICS, INC.</B></TD></TR>
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<TD VALIGN="top">Date: January&nbsp;7, 2019</TD>
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<TD VALIGN="top">By:</TD>
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<TD VALIGN="top"> <P STYLE="margin-top:0pt; margin-bottom:1pt; border-bottom:1px solid #000000; font-size:10pt; font-family:Times New Roman">/s/ Joel Sendek</P></TD></TR>
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<TD VALIGN="top">Joel Sendek</TD></TR>
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<TD VALIGN="top">Chief Financial Officer and Treasurer</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
SPERO THERAPEUTICS, INC.
(Exact Name of registrant as specified in its charter)
Delaware
001-38266
46-4590683
(State or other jurisdiction
of incorporation)
(Commission
File Number)
(IRS Employer
Identification No.)
675 Massachusetts Avenue, 14th Floor
Cambridge, Massachusetts 02139
(Address of principal executive offices and zip code)
Registrant's telephone number, including area code: (857)
242-1600
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:
☐
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 (17 CFR §230.405) or
Rule
12b-2
of the Securities Exchange Act of 1934 (17 CFR
§240.12b-2).
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 1.01
Entry into a Material Definitive Agreement.
On January 4, 2019, Spero Therapeutics, Inc. ("Spero"), through its wholly owned subsidiary New Pharma License Holdings Limited
("NPLH"), entered into a license agreement (the "License Agreement") with Everest Medicines II Limited ("Everest"), which License Agreement also includes an option granted by Spero's wholly owned subsidiary Spero
Potentiator, Inc., a Delaware corporation ("Potentiator" and, together with NPLH, the "Company"). Under the terms of the License Agreement, the Company granted Everest an exclusive license to develop, manufacture and
commercialize Spero's product candidate SPR206 (the "Compound") or products that contain the Compound (a "Licensed Product") in Greater China (which includes Mainland China, Hong Kong and Macau), South Korea and certain
Southeast Asian countries (collectively, the "Territory"). The Company retains development, manufacturing and commercialization rights with respect to the Compound and Licensed Products in the rest of the world and also retains the right
to develop or manufacture the Compound and Licensed Products in the Territory for use outside the Territory. In addition to the license grant to SPR206, the Company also granted Everest a
12-month
exclusive
option to negotiate with the Company for an exclusive license to develop, manufacture and commercialize Spero's product candidate SPR741 in the Territory.
Under the terms of the License Agreement, the Company is entitled to receive an upfront payment of $3 million. The Company may also
receive up to an additional $59.5 million in milestone payments upon Everest's achievement of certain developmental, regulatory and sales milestone events related to SPR206, which achievement cannot be guaranteed. The Company is also
entitled to receive high single-digit to low double-digit royalties on net sales, if any, of Licensed Products in the Territory following regulatory approval of the Compound. Everest has the right to sublicense to affiliates and third parties in the
Territory.
Everest is responsible for all costs related to developing, obtaining regulatory approval of and commercializing the Compound
and Licensed Products in the Territory, and is obligated to use commercially reasonable efforts to develop, manufacture and commercialize Licensed Products, including to achieve certain specified diligence milestones within agreed-upon periods. A
joint development committee will be established between the Company and Everest to coordinate and review the development, manufacturing and commercialization plans with respect to Licensed Products in the Territory.
Unless earlier terminated due to certain material breaches of the contract, or otherwise, the License Agreement will expire on a
jurisdiction-by-jurisdiction
and Licensed
Product-by-Licensed
Product basis until the latest to
occur of expiration of the last valid claim under a licensed patent in such jurisdiction, the expiration of regulatory exclusivity in such jurisdiction or ten years after the first commercial sale of such Licensed Product in such jurisdiction. The
License Agreement may be terminated in its entirety by Everest upon 90 or 180 days' prior written notice, depending on the stage of development of the initial Licensed Product.
The foregoing description of the terms of the License Agreement does not purport to be complete and is qualified in its entirety by reference
to the License Agreement, which Spero intends to file as an exhibit to its Quarterly Report on
Form 10-Q
for the quarterly period ending March 31, 2019. Spero intends to seek confidential treatment
for certain portions of the License Agreement pursuant to a Confidential Treatment Request to be submitted to the Securities and Exchange Commission pursuant to
Rule 24b-2 under
the Securities
Exchange Act of 1934, as amended.
On January 7, 2019, Spero issued a press release announcing the entry into the License Agreement,
a copy of which is filed herewith as Exhibit 99.1 and incorporated by reference herein.
Item 8.01
Other Events.
On January 7, 2019, Spero issued a press release providing regulatory and clinical updates for its product candidate SPR994, a copy of
which is filed herewith as Exhibit 99.2 and is incorporated herein by reference.
Item 9.01
Financial Statements and Exhibits.
(d)
Exhibits
Exhibit 99.1
Press Release, dated January 7, 2019.
Exhibit 99.2
Press Release, dated January 7, 2019.
SIGNATURE
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.
SPERO THERAPEUTICS, INC.
Date: January 7, 2019
By:
/s/ Joel Sendek
Joel Sendek
Chief Financial Officer and Treasurer