SecProbe.io

CORRESP
1
filename1.htm

Daniel
K. Donahue

Tel
949.732.6500

Fax
949.732.6501

donahued@gtlaw.com

February
20, 2023

Via
Edgar

Securities
and Exchange Commission

Division
of Corporation Finance

Office
of Life Sciences

100
F Street, N.E.

Washington,
DC 20549

Re: Azitra
                                            Inc

  Draft
                                            Registration Statement on Form S-1

  Submitted
                                            December 15, 2022

  CIK
                                            No. 0001701478

Ladies
and Gentlemen:

On
behalf of our client, Azitra Inc, a Delaware corporation (the “Company”), we are responding to the comment
letter issued by the staff of the Commission (the “Staff”) to Francisco Salva, President and Chief Executive
Officer of the Company, dated January 14, 2023 on the above-referenced draft Registration Statement on Form S-1. Concurrent with the
filing of this letter, the Company is publicly filing with the Commission its Registration Statement on Form S-1 (“Registration
Statement”).

The
Registration Statement has been prepared in response to Staff’s comment letter dated January 14, 2023, the text of which we have
incorporated into this response letter for your convenience.

Staff
Comment and Company Response

Draft
Registration Statement on Form S-1

Cover
Page

1. Please
                                            disclose on your cover page whether your offering is contingent upon the final approval of
                                            your listing. Please ensure the disclosure is consistent with your underwriting agreement.

Response:
The requested disclosure has been provided on the cover page. The form of underwriting agreement to be filed by amendment to the
Registration Statement will contain a representation and warranty from the Company. To further insure consistency, the final version
of the underwriting agreement that will be filed by the Company with a Current Report on Form 8-K will include the exchange listing approval
as a condition to the underwriter’s obligations to purchase the shares in the initial public offering.

    GREENBERG TRAURIG, LLP ■ ATTORNEYS AT LAW ■ WWW.GTLAW.COM

Securities
and Exchange Commission

Division
of Corporation Finance

February
20, 2023

Page
2

Prospectus
Summary

Our
Company, page 1

2. Please
                                            revise to explain whether your microbial drug candidates will be delivered topically or by
                                            other delivery methods.

Response:
All of the Company’s current product candidates are intended to be delivered topically. Appropriate disclosure has been provided
in the third paragraph on page 1 and elsewhere throughout the prospectus as appropriate.

Pipeline
Table, page 2

3. Please
                                            revise the table to include a column for Phase 3. Also, revise so that the “Preclinical”
                                            column is not wider than the Phase 1/2 column.

Response:
The requested revisions have been made on page 2.

4. Please
                                            remove the Consumer Health Programs from the table or tell us your basis for including these
                                            programs in the table showing your pipeline of biotherapeutic products. In this regard, it
                                            appears that Bayer holds the commercial rights to these programs and that you generate service
                                            revenues from the joint development agreement. Further, it is unclear whether the oleogel
                                            formulations generated from the partnership are subject to the drug/biologic regulatory process
                                            that is depicted in the pipeline table.

Response:
The Company respectfully submits that it is meaningful to include the product candidates being developed under the Bayer JDA in the pipeline
table. As noted in the fourth full paragraph on page 64, these products are the proprietary property of the Company. Pursuant
to the Bayer JDA, Bayer is funding the development of the products and, in return, has an option to exclusively license the products,
however at this time they are the property of the Company and will remain so until such time, if ever, as Bayer exercises its option
in accordance with the JDA and enters into a commercial license with the Company. The Company has revised the table and the disclosure
in the third full paragraph on page 2 and the fourth full paragraph on page 64 to clarify that the product candidates
are being developed as consumer products and will not expected to require a FDA New Drug Application or Biologics License Application
to be approved.

    GREENBERG TRAURIG, LLP ■ ATTORNEYS AT LAW ■ WWW.GTLAW.COM

Securities
and Exchange Commission

Division
of Corporation Finance

February
20, 2023

Page
3

5. Please
                                            revise to remove the “Discovery Programs” from the pipeline table. In this regard,
                                            we note that it appears premature to highlight them prominently in this table given their
                                            present development status. We further note that your Business discussion does not appear
                                            to provide disclosure concerning these programs.

Response:
The Company has removed the “Discovery Programs” from the pipeline table as requested.

Our
Market Opportunity, page 4

6. With
                                            a view to disclosure, please explain to us the basis for your disclosure that the global
                                            sales opportunity is $250 million.

Response:
According to several studies, the average prevalence of Netherton Syndrome is 1 in 100,000, or approximately 3,300 people in the U.S.
At an estimated cost of treatment of $170,000 per year, which the Company believes to be reasonable for an ultra-orphan drug such
as ATR-12, the Company estimates peak U.S. sales to be $100 million . With the global population estimated to be over 24 times
the US population, the $250 million projection is considered by the Company to be conservative. Please see page 56 of the
prospectus.

Summary
Financial Data, page 10

7. Please
                                            revise to disclose the historical and pro forma net loss per share information for all periods
                                            presented.

Response:
The Company has provided the requested disclosure related to historical periods; however, in order to provide the pro forma net loss
per share at this time, the Company would need the estimated offering price to compute the incremental common shares resulting from the
conversion of the convertible notes and preferred shares.

Use
of Proceeds, page 39

8. Please
                                            revise the disclosure in the first two bullet points to specify how much of the funding will
                                            be allocated toward each product candidate or program. Also disclose how far the proceeds
                                            will take you into the development process.

Response:
The Company has provided the requested disclosure on page 39.

Capitalization,
page 41

 9. Please
                                            revise your total capitalization balance to include the convertible notes payable.

Response:
The Company has revised the capitalization balance on page 41 as requested.

    GREENBERG TRAURIG, LLP ■ ATTORNEYS AT LAW ■ WWW.GTLAW.COM

Securities
and Exchange Commission

Division
of Corporation Finance

February
20, 2023

Page
4

Dilution,
page 42

10. Please
                                            revise to start your dilution disclosures with historical net tangible book value and per
                                            share information.

Response:
The Company respectfully submits that the addition of the historical net tangible book value per share may cause confusion and, in any
event, would be irrelevant to investors. At the close of this offering, approximately $5.4 million of debt represented by convertible
notes will convert to common stock along with all of the outstanding shares of convertible preferred stock. These conversions alone (and
without giving effect to this offering) will cause the Company’s net tangible book deficit at December 31, 2022 to
increase from approximately a negative $2.57 million to approximately a positive $4.0 million, and the number of outstanding
common shares will increase from 147,041 to approximately 2 million (both share figures pre-split). As of December 31, 2022, the
historical net tangible book deficit per share (pre-split) is approximately ($17.45), however the pro forma historical
net tangible book value per share (pre-split) as of December 31, 2022 and after taking into account the conversion of the convertible
promissory notes and convertible preferred stock, would be approximately $2.02 per share. These tangible book value per
share numbers will be proportionately reduced by way of the forward split the Company intends to effect prior to this offering, however
the range of variance between the two numbers will remain, and the historical net tangible book value per share amount (post-split) will
be far less dilutive than the pro forma historical net tangible book value per share (post-split).

In
conclusion, we believe that the historical net tangible book value per share adds a layer of complexity to the dilution discussion that
is unnecessary and not helpful in that it presents a distorted view of the Company’s net tangible book value at the time of the
offering. We are aware of several definitive IPO prospectuses that were subject to similar facts and presented the dilution discussion
in the manner provided by the Company.

Management’s
Discussion and Analysis of Financial Condition and Results of Operations

Research
and Development, page 46

11. Considering
                                            research and development to be your main operation, please address the following related
                                            comments:

 ● Please
                                            revise to disclose the nature of the components of your research and development expenses.
                                            In that regard, we note that you report grants earned as a negative research and development
                                            expense as disclosed on page F-9, and that you may also expense legal and filing expenses
                                            incurred related to the rejected patent as disclosed on page F-7.

Response:
The Company has provided the requested disclosure in the first paragraph on page 46. As discussed below, the Company does
not record legal expenses as part of research and development.

    GREENBERG TRAURIG, LLP ■ ATTORNEYS AT LAW ■ WWW.GTLAW.COM

Securities
                                            and Exchange Commission

Division
of Corporation Finance

February
20, 2023

Page
5

 ● Please
                                            tell us, and revise as necessary, how your accounting for legal work in connection with patent
                                            applications or litigation, and the sale or licensing of patents as research and development
                                            expenses is in accordance with ASC 730-10-55-2i.

Response:
The Company does not record legal expenses in connection with patent applications or litigation, and the sale or licensing of patents,
as research and development expenses. In accordance with ASC 730-10-55-2i, the Company excludes all legal expenses from research and
development expense. The Company capitalizes all legal expense in connection with patent applications and the licensing of patents as
intangible assets. Amortization associated with these patent costs is recorded as part of general and administrative expense.

 ● Please
                                            disclose whether you track your research and development expenses by program and/or by product
                                            candidates, and if so, provide a disaggregated disclosure for that. If not, disclose that
                                            fact and the reason you do not track them separately, and also consider providing a disaggregated
                                            disclosure such as by nature of costs. Please also separately disclose the amount of grant
                                            revenue recognized if significant.

Response:
As an early-stage private company, the Company does not allocate its human resources involved in research and development to any specific
drug candidate but plans to do so in the future. The Company does allocate certain research and development costs among its product candidates,
and is able to generally assess the changes in research and development expenses between the reported periods, however given that the
elated human resources costs are by far the greatest component of research and development expenses, the Company does not believe it
is meaningful to provide a break-down of only a portion of the research and development expenses. The Company will comply with the staff’s
request in future filings.

 ● Please
                                            revise to provide any known trends or uncertainties disclosures. e.g. total expected costs,
                                            or any expectations to increase, related to your expected future research and development
                                            expenses. Refer to Item 303(b)(2)(ii) of Regulation S-K.

Response:
The Company has added disclosure concerning its known trends in the third paragraph on page 46.

    GREENBERG TRAURIG, LLP ■ ATTORNEYS AT LAW ■ WWW.GTLAW.COM

Securities
                                            and Exchange Commission

Division
of Corporation Finance

February
20, 2023

Page
6

Liquidity
and Financial Condition, page 47

12. Revise
                                            to expand your liquidity disclosures to include a discussion that analyzes material cash
                                            requirements from known contractual and other obligations, including specification of the
                                            type of obligation and the relevant time period for the related cash requirements, as required
                                            by Item 303(b)(1) of Regulation S-K. In that regard, we note you disclosed certain lease
                                            obligations as well as obligations under license agreements.

Response:
The payment obligations under the Company’s license agreements are contingent in nature and not fixed obligations. The Company
has added disclosure concerning its operating lease obligations in the third paragraph on page 47.

ATR-12
for the treatment of Netherton syndrome, page 58

13. With
                                            reference to your disclosure at the top of page 63 concerning ATR-04, please provide similar
                                            disclosure concerning your 1b/2a trials for ATR-12.

Response:
The Company has provided the requested disclosure in the last paragraph on page 58.

Preclinical
data for ATR-12, page 59

14. Please
                                            expand your disclosure to include quantitative data supporting your claims that several in
                                            vivo and ex vivo experiments collectively support the potential efficacy of ATR-12 as a disease
                                            modifying therapy for pa