<SEC-DOCUMENT>0000950123-19-009069.txt : 20191210
<SEC-HEADER>0000950123-19-009069.hdr.sgml : 20191210
<ACCEPTANCE-DATETIME>20190920215025
<PRIVATE-TO-PUBLIC>
ACCESSION NUMBER:		0000950123-19-009069
CONFORMED SUBMISSION TYPE:	DRSLTR
PUBLIC DOCUMENT COUNT:		5
FILED AS OF DATE:		20190920

FILER:

	COMPANY DATA:	
		COMPANY CONFORMED NAME:			89bio, Inc.
		CENTRAL INDEX KEY:			0001785173
		STANDARD INDUSTRIAL CLASSIFICATION:	PHARMACEUTICAL PREPARATIONS [2834]
		IRS NUMBER:				831114349
		STATE OF INCORPORATION:			DE
		FISCAL YEAR END:			1231

	FILING VALUES:
		FORM TYPE:		DRSLTR

	BUSINESS ADDRESS:	
		STREET 1:		535 MISSION STREET
		STREET 2:		14TH FLOOR
		CITY:			SAN FRANCISCO
		STATE:			CA
		ZIP:			94105
		BUSINESS PHONE:		4155004614

	MAIL ADDRESS:	
		STREET 1:		535 MISSION STREET
		STREET 2:		14TH FLOOR
		CITY:			SAN FRANCISCO
		STATE:			CA
		ZIP:			94105
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</TABLE> <P STYLE="margin-top:12pt; margin-bottom:0pt; font-size:10pt; font-family:Times New Roman">September&nbsp;20, 2019 &nbsp;&nbsp;&nbsp;&nbsp; </P>
<P STYLE="margin-top:18pt; margin-bottom:0pt; font-size:10pt; font-family:Times New Roman"><U>CONFIDENTIAL SUBMISSION VIA EDGAR AND HAND DELIVERY </U></P> <P STYLE="margin-top:6pt; margin-bottom:0pt; font-size:10pt; font-family:Times New Roman">U.S.
Securities and Exchange Commission </P> <P STYLE="margin-top:0pt; margin-bottom:0pt; font-size:10pt; font-family:Times New Roman">Division of Corporation Finance </P>
<P STYLE="margin-top:0pt; margin-bottom:0pt; font-size:10pt; font-family:Times New Roman">Office of Healthcare&nbsp;&amp; Insurance </P> <P STYLE="margin-top:0pt; margin-bottom:0pt; font-size:10pt; font-family:Times New Roman">100 F Street, N.E.
</P> <P STYLE="margin-top:0pt; margin-bottom:0pt; font-size:10pt; font-family:Times New Roman">Washington, D.C. 20549 </P> <P STYLE="margin-top:0pt; margin-bottom:0pt; font-size:10pt; font-family:Times New Roman">Attn: Sonia Bednarowski and Dietrich
King </P> <P STYLE="font-size:6pt;margin-top:0pt;margin-bottom:0pt">&nbsp;</P>
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<TD WIDTH="5%" VALIGN="top" ALIGN="left">Re:</TD>
<TD ALIGN="left" VALIGN="top"> <P STYLE=" margin-top:0pt ; margin-bottom:0pt; font-size:10pt; font-family:Times New Roman; " ALIGN="left">89bio, Inc. </P></TD></TR></TABLE>
<P STYLE="margin-top:0pt; margin-bottom:0pt; margin-left:9%; font-size:10pt; font-family:Times New Roman">Draft Registration Statement on Form <FONT STYLE="white-space:nowrap">S-1</FONT> </P>
<P STYLE="margin-top:0pt; margin-bottom:0pt; margin-left:9%; font-size:10pt; font-family:Times New Roman">Submitted August&nbsp;16, 2019 </P>
<P STYLE="margin-top:0pt; margin-bottom:0pt; margin-left:9%; font-size:10pt; font-family:Times New Roman">Amendment No.&nbsp;1 to Draft Registration Statement on Form <FONT STYLE="white-space:nowrap">S-1</FONT> </P>
<P STYLE="margin-top:0pt; margin-bottom:0pt; margin-left:9%; font-size:10pt; font-family:Times New Roman">File <FONT STYLE="white-space:nowrap">No.&nbsp;377-02796</FONT> </P>
<P STYLE="margin-top:12pt; margin-bottom:0pt; font-size:10pt; font-family:Times New Roman">Ladies and Gentlemen: </P> <P STYLE="margin-top:6pt; margin-bottom:0pt; text-indent:4%; font-size:10pt; font-family:Times New Roman">On behalf of 89bio, Inc.
(the &#147;Company&#148;), this letter responds to the comments of the staff of the Securities and Exchange Commission Division of Corporate Finance (the &#147;Staff&#148;) contained in your letter, dated September&nbsp;12, 2019 (the &#147;Comment
Letter&#148;), regarding the above-referenced draft Registration Statement on Form <FONT STYLE="white-space:nowrap">S-1</FONT> (the &#147;Registration Statement&#148;), confidentially submitted on August&nbsp;16, 2019. Each of the Staff&#146;s
comments is set forth below, followed by the corresponding response. For ease of reference, the headings and numbered paragraphs below correspond to the headings and numbered comments in the Comment Letter. Each response of the Company is set forth
in ordinary type beneath the corresponding Staff comment, which is set out in bold type. The page references in our responses correspond to the page numbers of Amendment No.&nbsp;1 to the draft Registration Statement (the &#147;Amendment&#148;),
which is being confidentially submitted today. </P> <P STYLE="margin-top:12pt; margin-bottom:0pt; text-indent:4%; font-size:10pt; font-family:Times New Roman">Additionally, we note that the Amendment contains certain updated disclosures from what
was initially filed with the Registration Statement, including interim financial statements as of and for the period ended June&nbsp;30, 2019. </P> <P STYLE="font-size:12pt;margin-top:0pt;margin-bottom:0pt">&nbsp;</P>
<P STYLE="margin-top:12pt; margin-bottom:0pt; font-size:10pt; font-family:Times New Roman"><U>Prospectus Summary</U> </P> <P STYLE="margin-top:0pt; margin-bottom:0pt; font-size:10pt; font-family:Times New Roman"><U>Our Company</U> </P>
<P STYLE="margin-top:0pt; margin-bottom:0pt; font-size:10pt; font-family:Times New Roman"><U>Overview, page 1</U> </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"><B>1.</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>Please revise here and throughout to remove comparisons of your product candidates with other treatments,
product candidates and therapies. For example, on pages 1 and 112, you compare <FONT STYLE="white-space:nowrap">BIO89-100</FONT> to other products in development. In </B></P></TD></TR></TABLE>
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 </P> <P STYLE="margin-top:12pt; margin-bottom:0pt; font-size:10pt; font-family:Times New Roman">U.S. Securities and Exchange Commission </P>
<P STYLE="margin-top:0pt; margin-bottom:0pt; font-size:10pt; font-family:Times New Roman">September 20, 2019 </P> <p STYLE="margin-top:0pt;margin-bottom:0pt ; font-size:8pt">&nbsp;</P>

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addition, please revise here and throughout to eliminate any suggestion that your product candidates have been or will ultimately be determined safe or effective, as only the FDA and foreign
government equivalent regulations have the authority to make these determinations. For example, on page 1, you state that you believe that <FONT STYLE="white-space:nowrap">BIO89-100</FONT> may be a differentiated therapy based on, in part, to
improved efficacy. </B></TD></TR></TABLE> <P STYLE="margin-top:12pt; margin-bottom:0pt; font-size:10pt; font-family:Times New Roman">In response to the Staff&#146;s comment, the Company has revised its disclosure throughout the Amendment to remove
comparisons of its product candidates with other treatments, product candidates and therapies. In addition, the Company has revised its disclosure throughout the Amendment to eliminate suggestions that its product candidates have been or will
ultimately be determined safe or effective. The revised disclosures can be found on pages 1, 72, 84, 86, 87, 94 and 115 of the Amendment. </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"><B>2.</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>We note your disclosure that <FONT STYLE="white-space:nowrap">BIO89-100</FONT> may be a differentiated
therapy based, in part, on a more convenient dosing regimen. Please balance your disclosure here by disclosing that <FONT STYLE="white-space:nowrap">BIO89-100</FONT> must currently be stored as a frozen liquid and is therefore not well-suited to
commercialization and that there is not guarantee that you will be able to develop a refrigerated liquid formulation, <FONT STYLE="white-space:nowrap">freeze-dried</FONT> or lyophilized formulation of
<FONT STYLE="white-space:nowrap">BIO89-100.</FONT> </B></P></TD></TR></TABLE> <P STYLE="margin-top:12pt; margin-bottom:0pt; font-size:10pt; font-family:Times New Roman">In response to the Staff&#146;s comment, the Company has revised its disclosure
throughout the Amendment to replace the phrase &#147;convenient dosing regimen&#148; with the phrase &#147;longer dosing interval,&#148; which was the intended meaning of the original phrasing (i.e., that less frequent injections would be more
convenient to the patient), as discussed in further detail on page 115 of the Amendment. The revised disclosure can be found on pages 1, 2, 72, 84, 85, 86, 87, 94 and 115 of the Amendment. </P>
<P STYLE="margin-top:12pt; margin-bottom:0pt; font-size:10pt; font-family:Times New Roman">With respect to the risks that the Company may be unable to develop a refrigerated or <FONT STYLE="white-space:nowrap">freeze-dried</FONT> formulation of <FONT
STYLE="white-space:nowrap">BIO89-100,</FONT> the Company respectfully notes that the Registration Statement contains a risk factor on page 26 disclosing that <FONT STYLE="white-space:nowrap">BIO89-100</FONT> must currently be stored as a frozen
liquid and that there is no guarantee that it will be able to develop a refrigerated or <FONT STYLE="white-space:nowrap">freeze-dried</FONT> (lyophilized) formulation. </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"><B>3.</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>We note your disclosure of page 2 that &#147;[a]pproval of an SHTG treatment, driven by a combination of
smaller clinical trials and shorter timelines, can potentially represent a quicker path to market for <FONT STYLE="white-space:nowrap">BIO89-100.&#148;</FONT> Please tell us why you believe that your product candidate for the treatment of SHTG will
be approved with smaller clinical trials and shorter timelines. In addition, please disclose whether the FDA has indicated that you may conduct smaller trials for <FONT STYLE="white-space:nowrap">BIO89-100</FONT> for the treatment of SHTG as you
seek approval from the FDA for this indication. </B></P></TD></TR></TABLE> <P STYLE="margin-top:12pt; margin-bottom:0pt; font-size:10pt; font-family:Times New Roman">In response to the Staff&#146;s comment, the Company has revised its disclosure to
explain that the Company believes its product candidate for the treatment of SHTG can potentially be approved </P>
 <p STYLE="margin-top:0pt;margin-bottom:0pt ; font-size:8pt">&nbsp;</P> <P STYLE="margin-top:0pt; margin-bottom:0pt; font-size:10pt; font-family:Times New Roman" ALIGN="center">2 </P>

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 </P> <P STYLE="margin-top:12pt; margin-bottom:0pt; font-size:10pt; font-family:Times New Roman">U.S. Securities and Exchange Commission </P>
<P STYLE="margin-top:0pt; margin-bottom:0pt; font-size:10pt; font-family:Times New Roman">September 20, 2019 </P> <p STYLE="margin-top:0pt;margin-bottom:0pt ; font-size:8pt">&nbsp;</P>
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with smaller clinical trials and shorter timelines based on a published FDA surrogate endpoint table for drug approval that includes SHTG, as well as the development path followed by other
companies that have developed an SHTG therapy. The revised disclosures can be found on pages 2, 43, 72, 84, 86, 87 and 116 of the Amendment. In addition, the Company has revised page 43 of the Amendment to clarify that it does not have a Special
Protocol Assessment or other agreement with the FDA with respect to the required clinical trials needed to support an application for approval of <FONT STYLE="white-space:nowrap">BIO89-100</FONT> for the treatment of SHTG. </P>
<P STYLE="margin-top:12pt; margin-bottom:0pt; font-size:10pt; font-family:Times New Roman"><U>Our Lead Product Candidate, <FONT STYLE="white-space:nowrap">BIO89-100,</FONT> page 2</U> </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"><B>4.</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>We note your disclosure in the second paragraph of this section regarding the results of your preclinical
trials of <FONT STYLE="white-space:nowrap">BIO89-100.</FONT> Please limit the prospectus summary to a description of the endpoints of your clinical trials and whether they were met. To the extent that you do discuss preclinical trials in the
prospectus summary, please avoid conclusory statements regarding the results of these studies, and disclose a summary of how the tests were conducted, the number of animal models used, the number of tests conducted and the range of results observed
in these tests. In addition, we note your disclosure on page 2 that your single doses of 9.1mg and higher of <FONT STYLE="white-space:nowrap">BIO89-100</FONT> in your Phase 1a clinical trial of <FONT STYLE="white-space:nowrap">BIO89-100</FONT>
demonstrated statistically significant improvements in key lipid parameters measured at Day 8 and Day 15 after dosing on Day 1. Please disclose the <FONT STYLE="white-space:nowrap">p-value</FONT> used. </B></P></TD></TR></TABLE>
<P STYLE="margin-top:12pt; margin-bottom:0pt; font-size:10pt; font-family:Times New Roman">In response to the Staff&#146;s comment, the Company has revised the disclosure on page&nbsp;2. This includes a summary of how the tests were conducted, the
number of animal models used, the number of tests conducted and the range of results observed in these tests. The Company has also revised the disclosure on pages 2, 85 and 109 to include the resulting
<FONT STYLE="white-space:nowrap">p-value.</FONT> </P> <P STYLE="margin-top:12pt; margin-bottom:0pt; font-size:10pt; font-family:Times New Roman"><U>Implications of Being an Emerging Growth Company, page 5</U> </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"><B>5.</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>Please provide us with copies of all written communications, as defined in Rule 405 under the Securities
Act, that you, or anyone authorized to do so on your behalf, present to potential investors in reliance on Section&nbsp;5(d) of the Securities Act, whether or not they retain copies of the communications. </B></P></TD></TR></TABLE>
<P STYLE="margin-top:12pt; margin-bottom:0pt; font-size:10pt; font-family:Times New Roman">We acknowledge the Staff&#146;s comment and will supplementally provide the Staff with copies of all written communications used in reliance on
Section&nbsp;5(d) of the Securities Act. </P> <P STYLE="margin-top:12pt; margin-bottom:0pt; font-size:10pt; font-family:Times New Roman"><U>Risk Factors</U> </P>
<P STYLE="margin-top:0pt; margin-bottom:0pt; font-size:10pt; font-family:Times New Roman"><U>Risk Related to Regulatory Approvals</U> <U> </U></P>
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 </P> <P STYLE="margin-top:12pt; margin-bottom:0pt; font-size:10pt; font-family:Times New Roman">U.S. Securities and Exchange Commission </P>
<P STYLE="margin-top:0pt; margin-bottom:0pt; font-size:10pt; font-family:Times New Roman">September 20, 2019 </P> <p STYLE="margin-top:0pt;margin-bottom:0pt ; font-size:8pt">&nbsp;</P>
 <P STYLE="margin-top:0pt; margin-bottom:0pt; font-size:10pt; font-family:Times New Roman"><U>Even if we are able to obtain regulatory approvals for <FONT STYLE="white-space:nowrap">BIO89-100</FONT>
or any future product candidate, page 43</U> </P> <P STYLE="font-size:6pt;margin-top:0pt;margin-bottom:0pt">&nbsp;</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>We note your reference to <FONT STYLE="white-space:nowrap">BIO89-100</FONT> approved based upon a surrogate
endpoint pursuant to section 506(c) of the Federal Food, Drug, and Cosmetic Act and the accelerated approval regulations. Please revise to clarify whether the FDA has given you any indication that you may seek approval upon section 506(c) of the
Federal Food, Drug, and Cosmetic Act and the accelerated approval regulations. </B></P></TD></TR></TABLE> <P STYLE="margin-top:12pt; margin-bottom:0pt; font-size:10pt; font-family:Times New Roman">In response to the Staff&#146;s comment, the Company
has revised its risk factor on page 43 to clarify that the Company has not had any discussions with the FDA regarding a surrogate endpoint or accelerated approval regulations and that the reference to a surrogate endpoint is based on FDA guidance
from December 2018 regarding NASH generally. </P> <P STYLE="margin-top:12pt; margin-bottom:0pt; font-size:10pt; font-family:Times New Roman"><U>Risks Related to this Offering and Ownership of Our Common Stock Our Amended Certificate provides that
the Court of Chancery of the State of Delaware, page 60</U> </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"><B>7.</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>We note your disclosure on page 60 regarding your exclusive forum provision in your Amended Certificate.
However, on page 149, you state that your Amended Bylaws will contain the exclusive forum provision. Please revise for clarity and consistency. In addition, we note your disclosure that the exclusive forum provision identifies the federal district
courts as the exclusive forum for Securities Act claims. Please state that investors cannot waive compliance with the federal securities laws and the rules and regulations thereunder. In that regard, we note that Section&nbsp;22 of the Securities
Act creates concurrent jurisdiction for federal and state courts over all suits brought to enforce any duty or liability created by the Securities Act or the rules and regulations thereunder. To the extent that your exclusive forum provision does
not apply to actions arising under the Exchange Act, please ensure that the exclusive forum provision in the governing documents states this clearly, or tell us how you will inform investors in future filings that the provision does not apply to any
actions arising under the Exchange Act. </B></P></TD></TR></TABLE> <P STYLE="margin-top:12pt; margin-bottom:0pt; font-size:10pt; font-family:Times New Roman">In response to the Staff&#146;s comment, the Company has revised its disclosure on page 156
of the Amendment to clarify that the exclusive forum provision appears in the Company&#146;s Second Amended and Restated Certificate of Incorporation (the &#147;Amended Certificate&#148;) that will be effective upon the completion of the offering.
Additionally, the Company has revised its disclosure on page 61 of the Amendment to state that, &#147;under the Securities Act, federal courts have concurrent jurisdiction over all suits brought to enforce any duty or liability created by the
Securities Act, and investors cannot waive compliance with the federal securities laws and the rules and regulations thereunder.&#148; The Company respectfully advises the Staff that Article X of the Amended Certificate states that,
&#147;[n]otwithstanding anything herein to the contrary, and for the avoidance of doubt: (y)&nbsp;this Article shall not apply to suits brought to enforce a duty or liability created by the Securities Exchange Act of 1934, as amended&#133;&#148;
Accordingly, we </P>
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 </P> <P STYLE="margin-top:12pt; margin-bottom:0pt; font-size:10pt; font-family:Times New Roman">U.S. Securities and Exchange Commission </P>
<P STYLE="margin-top:0pt; margin-bottom:0pt; font-size:10pt; font-family:Times New Roman">September 20, 2019 </P> <p STYLE="margin-top:0pt;margin-bottom:0pt ; font-size:8pt">&nbsp;</P>
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believe that the Amended Certificate states clearly that the exclusive forum provision contained therein does not apply to actions arising under the Exchange Act. </P>
<P STYLE="margin-top:12pt; margin-bottom:0pt; font-size:10pt; font-family:Times New Roman"><U>Management&#146;s Discussion and Analysis of Financial Conditions and Results of Operations Agreements with Teva, page 72</U> </P>
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<TD WIDTH="4%" VALIGN="top" ALIGN="left"><B>8.</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>Your discussion regarding your Teva agreements on page 72 differs from that disclosed on pages 113 and <FONT
STYLE="white-space:nowrap">F-14</FONT> with respect to the number of agreements entered into and the associated milestone payments. Please revise to correct this apparent inconsistency. </B></P></TD></TR></TABLE>
<P STYLE="margin-top:12pt; margin-bottom:0pt; font-size:10pt; font-family:Times New Roman">In response to the Staff&#146;s comment, the Company has revised its disclosure on page 73 of the Amendment to harmonize the disclosure with that on pages
116, 117, <FONT STYLE="white-space:nowrap">F-17</FONT> and <FONT STYLE="white-space:nowrap">F-33</FONT> of the Amendment. </P> <P STYLE="margin-top:12pt; margin-bottom:0pt; font-size:10pt; font-family:Times New Roman"><U>Critical Accounting Policies
and Estimates Share-Based Compensation, page 79</U> </P> <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"><B>9.</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>Once you have an estimated offering price or range, please explain to us the reasons for any differences
between the recent valuations of your common stock and the estimated offering price. This information will help facilitate our review of your accounting for equity issuance including stock compensation and beneficial conversion features.
</B></P></TD></TR></TABLE> <P STYLE="margin-top:12pt; margin-bottom:0pt; font-size:10pt; font-family:Times New Roman">We acknowledge the Staff&#146;s comment and will supplementally provide the requested information as soon as an estimated offering
price or range is known. </P> <P STYLE="margin-top:12pt; margin-bottom:0pt; font-size:10pt; font-family:Times New Roman"><U>Business</U> </P> <P STYLE="margin-top:0pt; margin-bottom:0pt; font-size:10pt; font-family:Times New Roman"><U>Overview, page
81</U> </P> <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"><B>10.</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>Please disclose the material terms of the Sublicense Agreement with ratiopharm GMBH in an appropriate
section of your Business section. </B></P></TD></TR></TABLE> <P STYLE="margin-top:12pt; margin-bottom:0pt; font-size:10pt; font-family:Times New Roman">In response to the Staff&#146;s comment, the Company has added disclosure regarding the material
terms of the Sublicense Agreement with ratiopharm GmbH on pages 4, 49, 85, 86 and 117 of the Amendment. </P> <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"><B>11.</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>We note your disclosure on page 82 that, in diabetic obese cynomolgus monkeys with elevated triglycerides, <FONT
STYLE="white-space:nowrap">BIO89-100</FONT> showed significant effects on triglycerides at doses as low as 0.1mg/kg/week with a 78% reduction from baseline observed at the highest dose level of 1.0 mg/kg/week. Please revise to disclose here the
number of monkeys used in this study, the range of results observed and when the measurements of tryglycerides were measured. Similarly, please disclose the number of mice and diabetic obese cynomolgus in each preclinical study described
</B></P></TD></TR></TABLE>
 <p STYLE="margin-top:0pt;margin-bottom:0pt ; font-size:8pt">&nbsp;</P> <P STYLE="margin-top:0pt; margin-bottom:0pt; font-size:10pt; font-family:Times New Roman" ALIGN="center">5 </P>

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<p Style='page-break-before:always'>
<HR SIZE="3" style="COLOR:#999999" WIDTH="100%" ALIGN="CENTER">


<Center><DIV STYLE="width:8.5in" align="left">

 <P STYLE="margin-top:0pt;margin-bottom:0pt">


<IMG SRC="g743471dsp002.jpg" ALT="LOGO">
 </P> <P STYLE="margin-top:12pt; margin-bottom:0pt; font-size:10pt; font-family:Times New Roman">U.S. Securities and Exchange Commission </P>
<P STYLE="margin-top:0pt; margin-bottom:0pt; font-size:10pt; font-family:Times New Roman">September 20, 2019 </P> <p STYLE="margin-top:0pt;margin-bottom:0pt ; font-size:8pt">&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%">&nbsp;</TD>
<TD ALIGN="left" VALIGN="top"><B>
on pages 98 to 105, and disclose whether the data in the charts on pages 99 to 105 demonstrates the high, low or average results. In addition, we note your disclosure regarding the reduction of
tryclycerides in your Phase 1a SAD study. Please disclose here the range of results observed as well as the dose of <FONT STYLE="white-space:nowrap">BIO89-100.</FONT> </B></TD></TR></TABLE>
<P STYLE="margin-top:12pt; margin-bottom:0pt; font-size:10pt; font-family:Times New Roman">In response to the Staff&#146;s comment, the Company has revised its disclosure on page 85 of the Amendment to disclose the number of monkeys used in the
study, the range of results observed and when the measurements of triglycerides were measured. In addition, the Company has revised its disclosures on pages 101, 103 and 106 of the Amendment to disclose the number of mice and diabetic obese
cynomolgus monkeys in the preclinical study described on those respective pages. The Company has revised the charts on pages 102 to 108 of the Amendment to reflect that the data in such charts show mean results. </P>
<P STYLE="margin-top:12pt; margin-bottom:0pt; font-size:10pt; font-family:Times New Roman">With respect to the reduction of triglycerides in the Company&#146;s Phase 1a SAD study, the Company respectfully refers the Staff to Figure 24 on page 110,
which contains the range of results observed in this study, as well as the dose of <FONT STYLE="white-space:nowrap">BIO89-100.</FONT> </P> <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"><B>12.</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>We note your disclosure on page 82 regarding the patents for
<FONT STYLE="white-space:nowrap">BIO89-100.</FONT> Please clarify here, if true, that the patents and <FONT STYLE="white-space:nowrap">know-how</FONT> related to glycoPEGylation technology for use in the research, development, manufacture and
commercialization of <FONT STYLE="white-space:nowrap">BIO89-100</FONT> are licensed from TEVA. </B></P></TD></TR></TABLE> <P STYLE="margin-top:12pt; margin-bottom:0pt; font-size:10pt; font-family:Times New Roman">In response to the Staff&#146;s
comment, the Company has added disclosure on pages 4, 49, 73, 85, 86 and 117 of the Amendment to clarify that the patents and <FONT STYLE="white-space:nowrap">know-how</FONT> related to glycoPEGylation technology for use in the research,
development, manufacture and commercialization of <FONT STYLE="white-space:nowrap">BIO89-100</FONT> are licensed from Teva and ratiopharm GmbH, an affiliate of Teva. </P>
<P STYLE="margin-top:12pt; margin-bottom:0pt; font-size:10pt; font-family:Times New Roman"><U>Agreements with Teva</U> </P> <P STYLE="margin-top:0pt; margin-bottom:0pt; font-size:10pt; font-family:Times New Roman"><U>FASN Agreements, page 113</U>
</P> <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="5%" VALIGN="top" ALIGN="left"><B>13.</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>Please disclose any payments and royalties that must be paid in addition to the payments and royalties that
must be paid pursuant to the FGF21 Agreement with Teva. In this regard, we note your disclosure that the provisions in the FASN regarding milestones and royalties are analogous to the provisions contained in the FGF21 Agreement.
</B></P></TD></TR></TABLE> <P STYLE="margin-top:12pt; margin-bottom:0pt; font-size:10pt; font-family:Times New Roman">In response to the Staff&#146;s comment, the Company has added disclosure on page 117 of the Amendment regarding the payments and
royalties that must be paid to Teva pursuant to the FASN Agreement. </P> <P STYLE="margin-top:12pt; margin-bottom:0pt; font-size:10pt; font-family:Times New Roman"><U>Manufacturing and Supply, page 126 </U></P>
 <p STYLE="margin-top:0pt;margin-bottom:0pt ; font-size:8pt">&nbsp;</P> <P STYLE="margin-top:0pt; margin-bottom:0pt; font-size:10pt; font-family:Times New Roman" ALIGN="center">6 </P>

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<p Style='page-break-before:always'>
<HR SIZE="3" style="COLOR:#999999" WIDTH="100%" ALIGN="CENTER">


<Center><DIV STYLE="width:8.5in" align="left">

 <P STYLE="margin-top:0pt;margin-bottom:0pt">


<IMG SRC="g743471dsp002.jpg" ALT="LOGO">
 </P> <P STYLE="margin-top:12pt; margin-bottom:0pt; font-size:10pt; font-family:Times New Roman">U.S. Securities and Exchange Commission </P>
<P STYLE="margin-top:0pt; margin-bottom:0pt; font-size:10pt; font-family:Times New Roman">September 20, 2019 </P> <p STYLE="margin-top:0pt;margin-bottom:0pt ; font-size:8pt">&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"><B>14.</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>Please disclose the material terms of your Master Services Agreement with Biotechpharma UAB.
</B></P></TD></TR></TABLE> <P STYLE="margin-top:12pt; margin-bottom:0pt; font-size:10pt; font-family:Times New Roman">In response to the Staff&#146;s comment, the Company has added disclosure on page 131 of the Amendment regarding the material terms
of the Master Services Agreement with Biotechpharma UAB. </P>
 <p STYLE="margin-top:0pt;margin-bottom:0pt ; font-size:8pt">&nbsp;</P> <P STYLE="margin-top:0pt; margin-bottom:0pt; font-size:10pt; font-family:Times New Roman" ALIGN="center">7 </P>

</DIV></Center>


<p Style='page-break-before:always'>
<HR SIZE="3" style="COLOR:#999999" WIDTH="100%" ALIGN="CENTER">


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 <P STYLE="margin-top:0pt;margin-bottom:0pt">


<IMG SRC="g743471dsp002.jpg" ALT="LOGO">
 </P> <P STYLE="margin-top:12pt; margin-bottom:0pt; font-size:10pt; font-family:Times New Roman">U.S. Securities and Exchange Commission </P>
<P STYLE="margin-top:0pt; margin-bottom:0pt; font-size:10pt; font-family:Times New Roman">September 20, 2019 </P> <p STYLE="margin-top:0pt;margin-bottom:0pt ; font-size:8pt">&nbsp;</P>
 <P STYLE="margin-top:0pt; margin-bottom:0pt; text-indent:4%; font-size:10pt; font-family:Times New Roman">If you have any questions regarding the Amendment or the responses set forth above, please do
not hesitate to call me at (415) <FONT STYLE="white-space:nowrap">393-8373.</FONT> </P> <P STYLE="font-size:12pt;margin-top:0pt;margin-bottom:0pt">&nbsp;</P><DIV ALIGN="right">
<TABLE CELLSPACING="0" CELLPADDING="0" WIDTH="40%" BORDER="0" STYLE="BORDER-COLLAPSE:COLLAPSE; font-family:Times New Roman; font-size:10pt">


<TR>

<TD WIDTH="100%"></TD></TR>


<TR STYLE="page-break-inside:avoid ; font-family:Times New Roman; font-size:10pt">
<TD VALIGN="top">Sincerely,</TD></TR>
<TR STYLE="font-size:1pt">
<TD HEIGHT="16"></TD></TR>
<TR STYLE="page-break-inside:avoid ; font-family:Times New Roman; font-size:10pt">
<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/ Ryan A. Murr</P></TD></TR>
<TR STYLE="page-break-inside:avoid ; font-family:Times New Roman; font-size:10pt">
<TD VALIGN="top">Ryan A. Murr</TD></TR>
</TABLE></DIV> <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">cc:</TD>
<TD ALIGN="left" VALIGN="top"> <P STYLE=" margin-top:0pt ; margin-bottom:0pt; font-size:10pt; font-family:Times New Roman; " ALIGN="left">Rohan A. Palekar, 89bio, Inc. </P></TD></TR></TABLE>
<P STYLE="margin-top:0pt; margin-bottom:0pt; margin-left:4%; font-size:10pt; font-family:Times New Roman">Branden C. Berns, Gibson Dunn&nbsp;&amp; Crutcher LLP </P>
<P STYLE="margin-top:0pt; margin-bottom:0pt; margin-left:4%; font-size:10pt; font-family:Times New Roman">Divakar Gupta, Cooley LLP </P> <P STYLE="margin-top:0pt; margin-bottom:0pt; margin-left:4%; font-size:10pt; font-family:Times New Roman">Jonie
I. Kondracki, Cooley LLP </P> <P STYLE="margin-top:0pt; margin-bottom:0pt; margin-left:4%; font-size:10pt; font-family:Times New Roman">Robert W. Phillips, Cooley LLP </P>
<P STYLE="margin-top:0pt; margin-bottom:0pt; margin-left:4%; font-size:10pt; font-family:Times New Roman">Charles S. Kim, Cooley LLP </P>
 <p STYLE="margin-top:0pt;margin-bottom:0pt ; font-size:8pt">&nbsp;</P> <P STYLE="margin-top:0pt; margin-bottom:0pt; font-size:10pt; font-family:Times New Roman" ALIGN="center">8 </P>

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