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United States securities and exchange commission logo
September 15, 2020
Josep Bassaganya-Riera
Chairman, President and Chief Executive Officer
Landos Biopharma, Inc.
1800 Kraft Drive, Suite 216
Blacksburg, VA 24060
Re: Landos Biopharma,
Inc.
Amendment No. 1 to
Draft Registration Statement on Form S-1
Submitted September
1, 2020
CIK No. 0001785345
Dear Dr. Bassaganya-Riera:
We have reviewed your amended 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.
Amendment No. 1 to Draft Registration Statement on Form S-1 submitted
September 1, 2020
Prospectus Summary
Overview, page 1
1. We note your response
to prior comment 1 and continue to object to your statements that
you are focused on
developing "first-in-class" therapeutics and that your therapeutics are
potentially
"first-in-class." The qualifiers "if effective and approved" and "whereby our
product candidates use
unique and new mechanisms of action" do not address our
concerns that
"first-in-class" continues to imply (i) that your product candidates will be
effective and (ii) your
product candidates are likely to be the first treatments available,
neither of which is
appropriate at this stage of development. Please revise your
registration statement
to remove the phrase "first-in-class."
Josep Bassaganya-Riera
FirstName LastNameJosep
Landos Biopharma, Inc. Bassaganya-Riera
Comapany 15,
September NameLandos
2020 Biopharma, Inc.
September
Page 2 15, 2020 Page 2
FirstName LastName
You may state, if accurate, that your product candidates are the first
orally administered
therapeutics to target the LANCL2, NLRX1 and PLXDC2 pathways for the
treatment of
the various indications described in the prospectus. However, you may
not state or imply
that your product candidates will be the first products in this class
available.
Our portfolio, page 3
2. We note your response to prior comment 3 and updated disclosure and
reissue in part.
Please remove the "ongoing/completed" language from your pipeline
chart and adjust the
length of the bars to reflect whether studies or a trial is ongoing or
has been completed.
For example, for product candidates that are currently in a Phase I
trial, you may extend
the bar to the middle of the Phase I trial column, but not to the end.
We further note the distinction in your chart between "preclinical"
and "IND-enabling"
studies. As "IND-enabling" studies are preclinical, please revise your
table to eliminate
the distinction between the preclinical and IND-enabling studies and
show preclinical
only.
Our strengths, page 5
3. We note your response to prior comment 7. Please revise your
disclosure throughout the
document where the term "significant unmet medical need" is used to
clarify that you
have not yet had conversations with the FDA regarding fast track
designation or priority
review for your product candidates.
Our strategy, page 6
4. We note your response to prior comment 4. Your response supports the
statements that
you believe you are a leader in developing immunometabolic product
candidates for IBD
and understanding the immune effects of the LANCL2 pathway. However,
your response
does not support the claim that you are a leader in the broader field
of
immunometabolism, please revise your disclosure to remove this claim.
5. We note your response to prior comment 5 and reissue the comment. Your
prospectus
continues to state that you intend to "rapidly advance" your product
candidates and to
"accelerate" the discovery and development of therapeutics for
autoimmune diseases.
Please revise this disclosure and similar disclosure throughout the
prospectus to remove
any implication that you will be successful in commercializing your
product candidates in
a rapid or accelerated manner as such statements are speculative.
Business
Our Portfolio, page 89
6. Please remove the new pipeline graphic that you have inserted at the
end of "Our
portfolio" introduction. The graphic assumes regulatory approvals
which may or may not
Josep Bassaganya-Riera
Landos Biopharma, Inc.
September 15, 2020
Page 3
be granted and that the data from your preclinical studies and clinical
trials will permit
you to further progress each of your product candidates.
Our strengths, page 93
7. We note your statement that no dose-limiting toxicities have been
observed in doses up to
7-fold higher than the currently proposed therapeutic dose for BT-11 in
completed clinical
trials. The prospectus only references one completed clinical trial of
BT-11. Please update
your disclosure to describe any additional clinical trials of BT-11 that
have been
completed or revise your statement to clarify that only one trial of
BT-11 has been
completed.
Foundations of the LANCE platform, page 100
8. We refer to prior comment 13 and note that the graphic you have added at
the top of page
100 continues to state that your therapeutic candidates have improved
safety profiles.
Please remove any disclosure stating or implying that your product
candidates are safe as
that determination is within the authority of the FDA and comparable
regulatory bodies.
Consolidated balance sheets, page F-3
9. Please revise to only present the pro forma balance sheet as of June 30,
2020, the latest
balance sheet included in the filing. Also revise the footnote discussion
on page F-8 as
appropriate.
You may contact Jenn Do at 202-551-3743 or Kevin Kuhar at 202-551-3662
if you have
questions regarding comments on the financial statements and related matters.
Please contact
Alan Campbell at 202-551-4224 or Chris Edwards at 202-551-6761 with any other
questions.
Sincerely,
FirstName LastNameJosep Bassaganya-Riera
Division of
Corporation Finance
Comapany NameLandos Biopharma, Inc.
Office of Life
Sciences
September 15, 2020 Page 3
cc: Eric Blanchard
FirstName LastName