<SEC-DOCUMENT>0000000000-20-008589.txt : 20210115
<SEC-HEADER>0000000000-20-008589.hdr.sgml : 20210115
<ACCEPTANCE-DATETIME>20200911163945
<PRIVATE-TO-PUBLIC>
ACCESSION NUMBER:		0000000000-20-008589
CONFORMED SUBMISSION TYPE:	UPLOAD
PUBLIC DOCUMENT COUNT:		2
FILED AS OF DATE:		20200911

FILED FOR:		

	COMPANY DATA:	
		COMPANY CONFORMED NAME:			Virios Therapeutics, Inc.
		CENTRAL INDEX KEY:			0001818844
		STANDARD INDUSTRIAL CLASSIFICATION:	PHARMACEUTICAL PREPARATIONS [2834]
		IRS NUMBER:				854314201
		STATE OF INCORPORATION:			DE
		FISCAL YEAR END:			1231

	FILING VALUES:
		FORM TYPE:		UPLOAD

	BUSINESS ADDRESS:	
		STREET 1:		44 MILTON AVENUE
		CITY:			ALPHARETTA
		STATE:			GA
		ZIP:			30009
		BUSINESS PHONE:		8666208655

	MAIL ADDRESS:	
		STREET 1:		44 MILTON AVENUE
		CITY:			ALPHARETTA
		STATE:			GA
		ZIP:			30009

	FORMER COMPANY:	
		FORMER CONFORMED NAME:	Virios Therapeutics, LLC
		DATE OF NAME CHANGE:	20200721
</SEC-HEADER>
<DOCUMENT>
<TYPE>LETTER
<SEQUENCE>1
<FILENAME>filename1.pdf
<TEXT>
<PDF>
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United States securities and exchange commission logo





                              September 11, 2020

       Greg Duncan
       Chief Executive Officer
       Virios Therapeutics, LLC
       44 Milton Avenue
       Alpharetta, GA 30009

                                                        Re: Virios
Therapeutics, LLC
                                                            Registration
Statement on Form S-1
                                                            Filed August 28,
2020
                                                            File No. 333-248447

       Dear Mr. Duncan:

             We have reviewed your amended 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.
Unless we note
       otherwise, our references to prior comments are to comments in our
August 19, 2020 letter.

       Registration Statement on Form S-1 filed August 28, 2020

       Prospectus Summary, page 1

   1.                                                   We refer to prior
comment 1. Please further revise your disclosures on page 1 to disclose
                                                        that in the treatment
group, there were two serious adverse events, one of which is a non-
                                                        ST segment elevation
myocardial infarction, which may be treatment-related. Explain to
                                                        us why it is
appropriate to include a discussion in the Prospectus Summary of
                                                        discontinuation rates.
Also we note that the graphic above the timeline on page 5 appears
                                                        to be a remainder
reference to your surveys, and your graphic at the top of page 6 refers to
                                                        detailed study results
including p-values. Revise to delete the graphics.
   2.                                                   Please add a bullet in
your summary of risks section or balancing disclosure elsewhere in
                                                        the Prospectus Summary
to note that the fast track designation may not lead to a faster
 Greg Duncan
FirstName  LastNameGreg
Virios Therapeutics, LLC Duncan
Comapany 11,
September  NameVirios
               2020    Therapeutics, LLC
September
Page 2     11, 2020 Page 2
FirstName LastName
         development or regulatory review process. Additionally, revise the
summary of
         risks section so that they are of the same prominence as the
discussion of your strategies.
Building out our Pipeline, page 5

3.       We note your response to prior comment 6 and your revised pipeline
table. We note, in
         your response, that you will be relying on completed Phase 1 study
data for IMC-1.
         However, you do not disclose elsewhere in the prospectus the results
or completion of
         Phase 1 trials for IMC-1. If you have completed Phase 1 trials for
IMC-1 please describe
         them in your Business section. If you are not relying on Phase 1
trials for IMC-1, please
         clarify the table to make clear that you believe you will be able to
rely on the 505(b)(2)
         regulatory pathway for IBS and Functional Somatic Syndrome, and
disclose whether you
         have had discussions with the FDA regarding your ability to rely on
the pathway for IMC-
         1 for these two indications.
Risk Factors, page 13

4.       We note your revised disclosures on page 47 in response to prior
comment 12. Please
         expand your disclosures, including in the title of the risk factor,
either here or elsewhere,
         to also explain that Mr. Burch will be receiving equity awards in
connection with the
         IPO.
Management's Discussion and Analysis of Financial Condition and Results of
Operations
Research and Development Expenses, page 66

5.       We note your response to prior comment 14. Please further revise the
disclosure to break
         out the dollar amount of external research and development expenses
incurred for each
         period presented. Alternatively, disaggregate research and development
expenses by
         nature or type of expense for each period presented.
Business, page 72

6.       We acknowledge your revised disclosures in response to prior comment
17. However, we
         note your disclosure still includes many footnote references to
various external sources.
         We continue to note that it is not appropriate to refer investors to
external sources for
         additional information. To the extent you intend to retain your
discussion of the
         information from these sources, revise to disclose sufficient
information so that an
         investor may understand their significance without needing to refer to
these sources, and if
         you are referring to results from studies, clearly state whether you
are able to rely on such
         data in seeking FDA approval for your product candidates, and if you
are not, explain why
         such information is relevant. As examples only, you present a graphic
of patient
         prescription usage from 2008 to 2010 without sufficient narrative
information explaining
         how the results were derived, and you have multiple statements on page
79 discussing
         conclusions without sufficient information regarding those studies.
Additionally, as such
         detailed information is not appropriate for the Prospectus Summary,
please revise to
 Greg Duncan
FirstName  LastNameGreg
Virios Therapeutics, LLC Duncan
Comapany 11,
September  NameVirios
               2020    Therapeutics, LLC
September
Page 3     11, 2020 Page 3
FirstName LastName
         remove all references to external sources in such section.
7.       Please move the graphic on page 74 discussing secondary endpoints to
accompany your
         narrative discussion of the Phase IMC-1 trial so that the results are
shown in the
         appropriate context and ensure that there is narrative disclosure for
all information shown
         in the table.
Our Company, page 72

8.       We note your response to prior comment 4 and your revised disclosure
in various places
         of your prospectus. Please remove your statements on page 75 that you
are seeking to take
         IMC-1 to "being Phase 3 ready" after your Phase 2b trial, that you
"intend" for your Phase
         2b trial to "confirm the findings" in your Phase 2a study, and that
the studies will "help to
         further validate the potential of IMC-1."
Our Novel Mechanism of Action (   MOA   ), page 79

9.       We note your response to prior comment 3 and your revised disclosure
in the Prospectus
         Summary. Please remove your references here and elsewhere to any
statement that IMC-1
         has a "favorable" safety profile given this determination is solely
within the authority of
         the U.S. Food and Drug Administration.
Market and Competition, page 86

10.      We acknowledge your response to prior comment 5. However, we continue
to believe that
         consents are required from Lumleian and Triangle Insights Group
pursuant to Securities
         Act Rule 436 because your registration statement attributes certain
disclosures and
         conclusions to these entities. For guidance please refer to Question
141.02 of Compliance
         and Disclosure Interpretations for Securities Act Sections. In the
alternative, substantially
         revise your disclosures relating to these surveys so that disclosures
and conclusions are
         not attributed to them.
11.      We note your revised disclosures in response to prior comment 21 that
there are up to 21
         million Americans afflicted with fibromyalgia. As previously
requested, please revise
         your narrative disclosure to explain the basis for this conclusion. We
note that the
         National Fibromyalgia & Chronic Pain Association states on its website
that
         approximately 10 million Americans have fibromyalgia.
Board Composition and Election of Directors, page 105

12.      We note your response to prior comment 31 and your revised disclosure
on page 105.
         However, we still note inconsistencies throughout the prospectus on
when the certificate
         of incorporation will go into effect. For example on page 49 and page
105 you state that
         the certificate of incorporation will go into effect "effective upon
the closing of the
         offering." Please reconcile your disclosures.
 Greg Duncan
Virios Therapeutics, LLC
September 11, 2020
Page 4
Executive and Director Compensation
Employment Agreements, page 110

13.   We note that the employment agreement for Richard Burch contains
provisions relating to
      potential payments upon termination or change in control. Please revise
to discuss such
      provisions, as required by Item 402(q) of Regulation S-K.
        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 Vanessa Robertson at 202-551-3649 or Kevin Vaughn at
202-551-3494
if you have questions regarding comments on the financial statements and
related
matters. Please contact Jason Drory at 202-551-8342 or Dorrie Yale at
202-551-8776 with any
other questions.



                                                           Sincerely,
FirstName LastNameGreg Duncan
                                                           Division of
Corporation Finance
Comapany NameVirios Therapeutics, LLC
                                                           Office of Life
Sciences
September 11, 2020 Page 4
cc:       Darrick M. Mix, Esq.
FirstName LastName
</TEXT>
</DOCUMENT>
</SEC-DOCUMENT>
