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United States securities and exchange commission logo
March 10, 2023
Francisco Salva
President and Chief Executive Officer
Azitra Inc
21 Business Park Drive
Branford, CT 06405
Re: Azitra Inc
Registration
Statement on Form S-1
Filed February 21,
2023
File No. 333-269876
Dear Francisco Salva:
We have reviewed your 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 amending your registration
statement and providing the
requested information. 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 any amendment to your registration statement and
the information you
provide in response to these comments, we may have additional comments.
Form S-1 filed February 21, 2023
Our Company, page 1
1. We note your revised
disclosure in response to prior comment 2. Please revise the first
sentence in this
section to avoid any implication that your therapies presently "can be
applied topically to
treat diseases of the skin."
Our Strategy, page 2
2. We note your revised
disclosure on page 54 in response to prior comment 18. Please
revise your Summary
disclosure on page 2 to explain that the technology you license from
the Fred Hutchison
Cancer Center is not incorporated into any of your current product
candidates.
Francisco Salva
Azitra Inc
March 10, 2023
Page 2
Pipeline Table, page 2
3. We refer to prior comment 4 and note your revised pipeline table on
page 2 and its
inclusion in the new cover graphics. Please revise both pipeline
presentations to clarify the
status of the Consumer Health Programs and the commercialization
rights to the products
under development. In this regard, it is unclear what the arrow
depicts in this section. In
addition it is not clear from your presentation what the Bayer symbol
represents.
Our Market Oppportunity, page 4
4. We note your response to prior comment 6. With reference to your
disclosure on page 56,
please revise the disclosure on page 4 to clarify that the market
opportunity is an estimate
of the market in the mid-2030s. With reference to your disclosure on
page 66-67, tell us
whether the $250 million estimate takes into account that the US
composition of matter
patent covering recombinant bacteria for treating abnormal skin
conditions expires in
2035.
Our Business Strategies, page 52
5. We note your revised disclosures in response to prior comment 16.
Please revise the
disclosure concerning the clinical trial agreement with Yale to
explain the status of the
observational trial. Discuss material financial arrangements
concerning the agreement.
Bayer Joint Development Agreement, page 64
6. Please revise to disclose the term and termination provisions of the
Joint Development
Agreement and restore the disclosure concerning the option period.
Discuss the planned
timeline for conducting the in vitro and ex vivo characterization work
and any
other additional work that is required before there would be delivery
of the results of the
JDA development activities to Bayer. With reference to prior comment
21, please revise
to clarify that no commercial license has been negotiated and this
will only occur after
Bayer has reviewed the data.
Preclinical Data for ATR-01, page 64
FirstName LastNameFrancisco Salva
7. We note your response to our prior comment 17; however, please further
expand your
Comapany NameAzitra
disclosure Inc narrative disclosure to explain graphs B, C and D
regarding the
to include
March mouse models.
10, 2023 Page 2
FirstName LastName
Francisco Salva
FirstName
Azitra Inc LastNameFrancisco Salva
Comapany
March NameAzitra Inc
10, 2023
March3 10, 2023 Page 3
Page
FirstName LastName
General
8. Please remove the graphic highlighting the peak sales figure. In this
regard, we note that
you have not commenced clinical trials and your disclosure on page 56
indicates that the
estimate is based on multiple assumptions and is an estimate for the
market in the mid-
2030s. For additional guidance, please refer to Compliance Disclosure
Interpretations,
Securities Act Forms, Question 101.03.
We remind you that the company and its management are responsible for
the accuracy
and adequacy of their disclosures, notwithstanding any review, comments, action
or absence of
action by the staff.
Refer to Rules 460 and 461 regarding requests for acceleration. Please
allow adequate
time for us to review any amendment prior to the requested effective date of
the registration
statement.
You may contact Li Xiao at 202-551-4391 or Lynn Dicker at 202-551-3616
if you have
questions regarding comments on the financial statements and related matters.
Please contact
Cindy Polynice at 202-551-8707 or Joe McCann at 202-551-6262 with any other
questions.
Sincerely,
Division of
Corporation Finance
Office of Life
Sciences
cc: Daniel K. Donahue, Esq.