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September 12, 2019
Rohan Palekar
Chief Executive Officer
89bio, Inc.
535 Mission Street, 14th Floor
San Francisco, CA 94105
Re: 89bio, Inc.
Draft Registration Statement on Form S-1
Submitted August 16, 2019
File No. 377-02796
Dear Mr. Palekar:
We have reviewed your draft registration statement and have the
following comments. In
some of our comments, we may ask you to provide us with information so we may
better
understand your disclosure.
Please respond to this letter by providing the requested information and
either submitting
an amended draft registration statement or publicly filing your registration
statement on
EDGAR. If you do not believe our comments apply to your facts and circumstances
or do not
believe an amendment is appropriate, please tell us why in your response.
After reviewing the information you provide in response to these comments
and your
amended draft registration statement or filed registration statement, we may
have additional
comments.
Draft Registration Statement on Form S-1
Prospectus Summary
Our Company
Overview, page 1
1. 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 BIO89-100 to other products in development. In 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 BIO89-100 may be a
differentiated therapy based
Rohan Palekar
FirstName LastNameRohan Palekar
89bio, Inc.
Comapany 12, 2019
September Name89bio, Inc.
September 12, 2019 Page 2
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FirstName LastName
on, in part, to improved efficacy.
2. We note your disclosure that BIO89-100 may be a differentiated therapy
based, in part, on
a more convenient dosing regimen. Please balance your disclosure here
by disclosing that
BIO89-100 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, freeze-dried or lyophilized
formulation of BIO89-100.
3. We note your disclosure of page 2 that "[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 BIO89-100." 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 BIO89-100 for the treatment of SHTG as
you seek approval
from the FDA for this indication.
Our Lead Product Candidate, BIO89-100, page 2
4. We note your disclosure in the second paragraph of this section
regarding the results of
your preclinical trials of BIO89-100. 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 BIO89-100 in your Phase
1a clinical trial of
BIO89-100 demonstrated statistically significant improvements in key
lipid parameters
measured at Day 8 and Day 15 after dosing on Day 1. Please disclose
the p-value used.
Implications of Being an Emerging Growth Company, page 5
5. 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 5(d) of the Securities Act,
whether or not they
retain copies of the communications.
Risk Factors
Risks Related to Regulatory Approvals
Even if we are able to obtain regulatory approvals for BIO89-100 or any future
product
candidate, page 43
6. We note your reference to BIO89-100 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
Rohan Palekar
FirstName LastNameRohan Palekar
89bio, Inc.
Comapany 12, 2019
September Name89bio, Inc.
September 12, 2019 Page 3
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FirstName LastName
Cosmetic Act and the accelerated approval regulations.
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
7. 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 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.
Management's Discussion and Analysis of Financial Conditions and Results of
Operations
Agreements with Teva, page 72
8. Your discussion regarding your Teva agreements on page 72 differs from
that disclosed
on pages 113 and F-14 with respect to the number of agreements entered
into and the
associated milestone payments. Please revise to correct this apparent
inconsistency.
Critical Accounting Policies and Estimates
Share-Based Compensation , page 79
9. 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.
Business
Overview, page 81
10. Please disclose the material terms of the Sublicense Agreement with
ratiopharm GMBH in
an appropriate section of your Business section.
11. We note your disclosure on page 82 that, in diabetic obese cynomolgus
monkeys with
elevated triglycerides, BIO89-100 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
Rohan Palekar
89bio, Inc.
September 12, 2019
Page 4
measured. Similarly, please disclose the number of mice and diabetic
obese cynomolgus
in each preclinical study described 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 BIO89-
100.
12. We note your disclosure on page 82 regarding the patents for
BIO89-100. Please clarify
here, if true, that the patents and know-how related to
glycoPEGylation technology for use
in the research, development, manufacture and commercialization of
BIO89-100
are licensed from TEVA.
Agreements with Teva
FASN Agreements, page 113
13. 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.
Manufacturing and Supply, page 126
14. Please disclose the material terms of your Master Services Agreement
with
Biotechpharma UAB.
You may contact Andi Carpenter at 202-551-3645 or Angela Connell at
202-551-3426 if
you have questions regarding comments on the financial statements and related
matters. Please
contact Sonia Bednarowski at 202-551-3666 or Dietrich King at 202-551-8071 with
any other
questions.
FirstName LastNameRohan Palekar Sincerely,
Comapany Name89bio, Inc.
Division of
Corporation Finance
September 12, 2019 Page 4 Office of
Healthcare & Insurance
FirstName LastName