# EDGAR Filing Document

**Accession Number:** 0001701478
**File Stem:** 0000000000-23-002378
**Filing Date:** 2023-3
**Character Count:** 12218
**Document Hash:** 3dc2cb877ad182ff28859646a236a3ff
**Contains OCR:** False
**Source Format:** 

## Filing Content

## Filing Summary
**0000000000-23-002378.hdr.sgml**: 20230718

**ACCESSION NUMBER**: 0000000000-23-002378

**CONFORMED SUBMISSION TYPE**: UPLOAD

**PUBLIC DOCUMENT COUNT**: 2

**FILED AS OF DATE**: 20230310

**FILED FOR**: 

**COMPANY DATA:**
- **COMPANY CONFORMED NAME:** Azitra Inc
- **CENTRAL INDEX KEY:** 0001701478
- **STANDARD INDUSTRIAL CLASSIFICATION:** PHARMACEUTICAL PREPARATIONS [2834]
- **IRS NUMBER:** 464478536
- **STATE OF INCORPORATION:** DE
- **FISCAL YEAR END:** 1231

**FILING VALUES:**
- **FORM TYPE:** UPLOAD

**BUSINESS ADDRESS:**
- **STREET 1:** 21 BUSINESS PARK DRIVE, SUITE 6
- **CITY:** BRANFORD
- **STATE:** CT
- **ZIP:** 06405
- **BUSINESS PHONE:** (203) 489-0183

**MAIL ADDRESS:**
- **STREET 1:** 21 BUSINESS PARK DRIVE, SUITE 6
- **CITY:** BRANFORD
- **STATE:** CT
- **ZIP:** 06405
**PUBLIC REFERENCE ACCESSION NUMBER**: 0001493152-22-035618

## Text-Extract

```

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.

```

### Attached PDF Documents

**Attachment 1:** `filename1`

![img-0.jpeg](img-0.jpeg)

CORPORATION FINANCE

# UNITED STATES  
SECURITIES AND EXCHANGE COMMISSION  
WASHINGTON, D.C. 20549

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 Opportunity, 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

7. We note your response to our prior comment 17; however, please further expand your disclosure to include narrative disclosure to explain graphs B, C and D regarding the mouse models.

Francisco Salva
Azitra Inc
March 10, 2023
Page 3

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.