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United States securities and exchange commission logo
August 20, 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.
Draft Registration
Statement on Form S-1
Submitted July 24,
2020
CIK No. 0001785345
Dear Dr. Bassaganya-Riera:
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
Overview, page 1
1. We note your statements
here and throughout your document that you are focused on the
development of
potentially "first-in-class" therapeutics and that certain of your product
candidates are
potentially "first-in-class." This term suggests that your therapeutics and
product candidates are
effective and likely to be approved, particularly given your claims
regarding your
pioneering of a new treatment paradigm in immunometabolism based on
novel pathways. Please
delete these references throughout your document. If your use of
Josep Bassaganya-Riera
FirstName LastNameJosep
Landos Biopharma, Inc. Bassaganya-Riera
Comapany
August 20, NameLandos
2020 Biopharma, Inc.
August
Page 2 20, 2020 Page 2
FirstName LastName
the term was designed to convey your belief that your product
candidates are based on a
differentiated technology or approach, you may discuss how your
technology or approach
differs from those of your competitors.
Our portfolio, page 3
2. We note your discussion of your development times for your product
candidates. Please
balance your disclosure here and on pages 85 and 92 to clarify that
the process of clinical
development is inherently uncertain and that there can be no guarantee
that you will
achieve similar development timelines with your future product
candidates.
3. Please shorten the orange bars in your pipeline chart here and on page
85 to more
accurately indicate the development status of each product candidate
displayed in the
chart. As an example, we note that your Phase II clinical trial of
BT-11 for UC is ongoing,
but that the orange bar extends to the end of the Phase II header in
the chart and that
you expect to initiate your Phase I clinical trial of BT-11 for EoE in
the second half of
2021, but that the orange bar extends to the end of the Phase I
header.
Please also remove the dark blue bars from the chart. You may discuss
planned or
prepared next steps for your product candidates below the pipeline
chart.
Our strategy, page 5
4. We note your statement that you are a "leader in the field of
immunometabolism." Please
explain to us to basis for this claim; we note that your most advanced
product candidate is
in a Phase 2 clinical trial and that you have not yet obtained a
regulatory approval for a
product candidate.
5. We note your disclosure here and throughout the document referencing
your plans to
"rapidly advance" the development of your product candidates and to
"accelerate the
development of new therapeutic products". 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.
Our strengths, page 5
6. We note your statements here and on page 88 that you have pioneered "a
leading drug
development engine." Given the early stage of your product candidates,
it appears to be
premature for you to claim that you possess a leading drug development
engine at this
time. Please revise your disclosure to remove this statement.
7. We note your use of the term significant unmet medical need here
and elsewhere in
the document. Such a term might imply that your products are eligible
for fast
track designation or priority review granted by the FDA for products
that treat certain
serious unmet medical needs. Please remove your use of this term
throughout or
otherwise please explain why you believe use of this term is
appropriate.
Josep Bassaganya-Riera
FirstName LastNameJosep
Landos Biopharma, Inc. Bassaganya-Riera
Comapany
August 20, NameLandos
2020 Biopharma, Inc.
August
Page 3 20, 2020 Page 3
FirstName LastName
Implications of being an emerging growth company, page 7
8. Please supplementally 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
We have a limited operating history, have not completed any clinical trials...,
page 12
9. We note your statement that you have not yet completed any clinical
trials as well as your
statement on page 98 that you are currently conducting a Phase 1
clinical trial of BT-11
for mild to moderate UC. We further note your discussion of the Phase
1 clinical trial of
BT-11 on page 102, which appears to claim that a Phase 1 clinical
trial of BT-11 has been
completed. Please update your disclosure to clarify the status of your
Phase 1 trial for BT-
11.
Critical accounting policies and significant judgments and estimates , page 79
10. We note from pages 164-165 and 176 that no equity awards, including
options, were
granted during 2019. Please revise to disclose the extent to which any
stock-based
compensation has been awarded during 2020. Once you have an estimated
offering price
or range, please explain to us how you determined the fair value of
the common stock
underlying equity issuances and the reasons for any differences
between the valuations of
your common stock leading up to the initial public offering and the
estimated offering
price for any grants made in 2020. This information will help
facilitate our review of your
accounting for equity issuances including stock compensation.
Business
Autoimmune market opportunity, page 87
11. Please update your disclosure to provide the source for the numbers in
the figure
underneath Large market opportunities for product candidates
targeting IBD . Please
also balance your disclosure regarding the sales of Entyvio, Humira
and Stelara to clarify
that there is no guarantee that any of your product candidates will be
approved by the
FDA and that, even if they are approved, there is no guarantee that
you will earn revenues
comparable to any of these approved products.
Our strategy, page 90
12. We note your claim that you have progressed BT-11 from initial
discovery to a potential
Phase 3 trial in less than three years. Given that you have yet to
complete a Phase 2 trial
for BT-11, this claim appears to be premature. Please remove or revise
this disclosure.
Josep Bassaganya-Riera
FirstName LastNameJosep
Landos Biopharma, Inc. Bassaganya-Riera
Comapany
August 20, NameLandos
2020 Biopharma, Inc.
August
Page 4 20, 2020 Page 4
FirstName LastName
Foundations of the LANCE platform, page 95
13. We note your statements that your product candidates targeting LANCL2
and NLRX1
have demonstrated the ability to modulate signaling without creating
safety concerns and
that improved "safety profiles" may enable your product candidates to
be developed to
move early into the treatment paradigm. Please remove any disclosure
here and
throughout the document stating or implying that your product
candidates are safe as that
determination is within the authority of the FDA and comparable
regulatory bodies.
BT-11, an oral LANCL2 agonist for the treatment of ulcerative colitis and Crohn
s disease, page
98
14. We note your statement that BT-11 has promising human proof of concept
data. However,
the only human proof of concept data in the prospectus appears to be
the measure of
calprotectin in your Phase 1 clinical trial. Please update your
disclosure to clarify whether
other human proof of concept data has been observed. Please also
update your description
of the results of your Phase 1 clinical trial to discuss whether the
calprotectin
measurement results were powered for statistical significance.
Our solution for treatment of UC, page 101
15. We note your statement that BT-11 greatly exceeded the efficacy of
other therapeutics in
development in terms of number and diversity of models in side-by-side
clinical testing.
The pre-clinical comparative information for BT-11 that is presented
in your document
appears to cover one pre-clinical study that measured disease activity
index, leukocytic
infiltration and calprotectin for BT-11 and three comparative
therapies. Please revise your
initial statement to reflect the results of the pre-clinical study or
explain why the statement
is accurate.
Phase 1 clinical trial of BT-11 by single ascending dose and multiple ascending
dose in normal
healthy participants, page 102
16. Please update your discussion of your Phase 1 clinical trial of BT-11
to state whether any
adverse events or serious adverse events occurred over the course of
the trial and whether
any such events were linked to treatment. To the extent that any
treatment-related adverse
events were observed, please describe the nature of such events.
Description of capital stock
Stock exchange listing, page 180
17. If true, please revise to correct the intended trading symbol from
LBAP" to "LABP", as
indicated elsewhere in your document (cover and pages 8 and 192).
Josep Bassaganya-Riera
Landos Biopharma, Inc.
August 20, 2020
Page 5
Report of independent registered public accounting firm, page F-2
18. Please have your auditors revise their report to include the city and
state where it was
issued, as required by Rule 2-02(a)(3) of Regulation S-X.
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 Christopher 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
August 20, 2020 Page 5
cc: Eric Blanchard
FirstName LastName