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VIA EDGAR AND FEDEX

Division of Corporation Finance

Securities and Exchange Commission

100 F Street, N.E.

Washington, D.C. 20549

On behalf of our client, Virios Therapeutics, LLC (the “Registrant”), we are responding to the comments of the staff (the “Staff”) of the Securities and Exchange Commission (the “Commission”) contained in its letter dated August 19, 2020 (the “Comment Letter”) relating to the above referenced Draft Registration Statement (the “Draft Registration Statement”).

Set forth below are the Registrant’s responses to the Staff’s comments. The numbering of the paragraphs below corresponds to the numbering of the Staff’s comments, which for your convenience we have incorporated into this response letter. Page references in the text of this response letter correspond to the page numbers of the Registration Statement on Form S-1 (the “Registration Statement”) filed today. We also describe below the changes the Registrant has made in response to the Staff’s comments in the Registration Statement and the prospectus included therein.

For the Staff’s convenience, we are submitting copies of this letter, clean copies of the Amendment and copies of the Registration Statement marked to show all changes from the Draft Registration Statement via email.

Prospectus Summary, page 1

The Registrant has revised pages 1- 6 to limit discussion of clinical trial results to endpoints of the trial.

How does IMC-1 work?, page 1

The Registrant has revised the prospectus to remove speculative statements and to clarify that IMC-1 is not a product at this time but a development candidate at this time.

Our Novel Mechanism of Action ("MOA"), page 1

The Registrant has revised the prospectus to remove implications that the Phase 2a proof of concept study allows the Registrant to determine that IMC-1 is safe.

Our Experience Leads Us Down an Efficient Regulatory and Development Pathway, page 3

You also have similar and additional statements elsewhere in your prospectus, including on page 88, where you state that "Phase 2b probability of success calculates a significantly higher success ratio compared to benchmarks. . . [t]his higher probability of success is due to the high statistically significant endpoints shown in the Phase 2a study and the well characterized safety of the non-NME formulation of IMC-1," and your statement on page 91 that broad clinical utility is to be "further confirmed" in your Phase 2b/3 trials. These types of statements are speculative and not appropriate as they imply successful results from your anticipated trial, or that your trial will be rapidly concluded. Please revise all such statements in your prospectus accordingly.

The Registrant has revised the prospectus to remove statements that are speculative as to the future results Phase 2b or Phase 3 trials and the timing of such trials.

What is FM and why was it selected as the first disease target for IMC-1?, page 5

The Registrant has revised page 4 to remove references to surveys in the Summary section of the Prospectus. The Registrant has revised page 77 to clarify when the survey was conducted and provide additional details regarding how the survey was conducted.

Further, the Registrant respectfully submits that Lumleian and Triangle Insights Group are not “experts” within the meaning of Rule 436 of the Securities Act and, accordingly, the Registrant does not believe a consent is required to be filed as an exhibit to the Registration Statement.

Rule 436 of the Securities Act requires that a consent be filed if any portion of a report or opinion of an “expert” is quoted or summarized as such in a registration statement. Section 7 of the Securities Act provides that an expert is “any accountant, engineer, or appraiser, or any person whose profession gives authority to a statement made by him.”

Lumleian and Triangle Insights Group are both consulting firms that primarily collect and aggregate survey and statistical data, and the related information contained in the registration statement reflects the aggregate survey and collected data. The Registrant submits that such data does not reflect the opinion or judgment of an “expert,” and that Lumleian and Triangle Insights Group are not amongst the enumerated professions under Section 7 of the Securities Act, nor is it within a “profession [that] gives authority to a statement made by [such providers].” As such, the Registrant believes that Lumleian and Triangle Insights Group are not among the class of persons subject to Section 7 and Rule 436 of the Securities Act as “experts” unless the Registrant expressly identifies it as an expert or the statements are purported to be made on the authority of such provider as an “expert.” The Registrant has neither expressly identified Lumleian or Triangle Insights Group as an “expert” in the registration statement nor purported to make statements in the registration statement on the authority of either Lumleian or Triangle Insights Group as an “expert.” Accordingly, the Registrant believes that Lumleian and Triangle Insights Group should not be considered “experts” within the meaning of U.S. federal securities laws.

In addition, the Registrant notes that the consent requirements of Rule 436 of the Securities Act are generally directed at circumstances in which an issuer has engaged a third-party expert or counsel to prepare a valuation, opinion or other report specifically for use in connection with or incorporated into a registration statement. In this instance, the Registrant respectfully advises the Staff that the data was prepared by Lumleian and Triangle Insights Group for the Registrant for research purposes, not as a report for purposes of the registration statement. The reports were not intended as an industry report to be used in or incorporated into the registration statement, but rather to make an assessment of the Registrant’s marketplace. As such, the data provided by each was not prepared specifically in connection with or for the purpose of inclusion in the registration statement or to otherwise satisfy any specific disclosure requirement.

As a result of the foregoing, the Registrant respectfully submits that Lumleian and Triangle Insights Group do not need to provide a consent to be filed as an exhibit to the registration statement.

Building out our Pipeline, page 7

The Registrant has revised the chart and disclosure on page 6 to more clearly indicate that the Phase 2a study has been completed and that Phase 1 trials are not needed by the Registrant for IBS and Functional Somatic Syndrome. Phase 1 studies are not required for each indication pursued at the molecular level because the completed IMC-1 Phase 1 supports all forward potential therapeutic targets for the development candidate. If the Registrant pursues those paths it may move directly to Phase 2 trials.

FM Phase 2b Clinical Program Timelines Expected to Deliver Results in Q4 2021, page 7

The Registrant has revised page 5 and page 86 to clarify that the Registrant expects topline results in Q1 2022 and has revised the table to remove the reference to “DBL.”

Our Leadership Team, page 8

The Registrant has revised page 6 to remove the reference to Mr. Phelan.

Implications of Being an Emerging Growth Company, page 10

The Registrant acknowledges your request and confirms that there are no written communications, as defined in Rule 405 under the Securities Act, that the Registrant, or anyone authorized to do so on the Registrant’s behalf, will present to potential investors in reliance on Section 5(d) of the Securities Act other than what will be filed with the Commission as a free writing prospectus pursuant to Rule 433.

Risk Factors, page 15

The Registrant has revised page 20 to disclose the serious adverse events observed.

The Registrant has revised pages 9, 49 and 70 to clarify that the Registrant has elected to take advantage of the extended transition period under Section 107(b) of the JOBS Act.

The Registrant has revised page 47 to include an additional risk factor relating to the interests of the directors and officers of the Registrant and their combined holdings after the closing of the offering.

Use of Proceeds, page 56

The Registrant has revised page 54 to clarify that it expects the proceeds of the offering to be sufficient to complete the IMC-1 FM Phase 2b trial and the chronic toxicology study.

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

Research and Development Expenses, page 68

The Registrant has revised page 64 to included expanded disclosure on research and development expenses.

The Registrant evaluated all costs presented as research and development costs and determined that the patent costs are related to activities similar to those described in ASC 730-10-55-2i. Accordingly, the Registrant concluded the activities do not meet the definition of research and development activities. The amount of patent costs included in research and development expenses for the six months ended June 30, 2020 and 2019 were $33,705 and $15,789, respectively.  For the years ended December 31, 2019 and 2018 patent costs included in research and development expense were $35,555 and $39,386, respectively. The Registrant evaluated the effect of these errors in classification under ASC 250, Accounting Changes and Error Corrections, Staff Accounting Bulletin (“SAB”) No. 108, Considering the Effects of Prior Year Misstatements when Quantifying Misstatements in Current Year Financial Statements and SAB No. 99, Materiality. The errors did not materially misstate any previously issued financial statements and the correction of the errors prospectively is also not expected to be material. The Registrant considered both quantitative and qualitative characteristics of the errors and required corrections and determined it was not necessary to restate the financial statements or unaudited interim period financial statements that were previously issued. The Registrant will reclassify the amounts to general and administrative expenses and disclose the correction to conform the comparative amounts with the proper presentation of costs in future filings. In light of the immateriality of the change and underlying amounts, the Registrant has removed the disclosure of the increase in patent costs to remove the apparent contradiction with accounting under ASC 730-10-55-2i.

Founders' Vision, page 73

The Registrant has revised page 71 to clarify that Dr. Pridgen conducted the study in his private practice. The University of Alabama assisted with the corroboration of his findings, as further described on page 81.

The Registrant has revised page 71 to remove the implication that IMC-1 is effective in treating fibromyalgia.

Business, page 74

In response to this comment, the Registrant has carefully reviewed each instance in which it cites to an external source. The Registrant respectfully submits that it has not referred investors to outside sources for the purpose of meeting its disclosure obligation. Rather, the Registrant has included citations for certain information as a way of providing the support for the statistics and other information actually included in the registration statement and does not intend that investors should review such external sources to gather additional information.

Notwithstanding the foregoing, based on its review of the citations to external sources, the Registrant has removed nine of the citations, including in the discussion of the secondary endpoints of the Phase 2a trial, and has revised the Registration on pages 76, 77, and 79, accordingly.

Further, the Registrant has revised the Registration Statement to ensure that each chart is labeled and there is a narrative disclosure accompanying each. 

The Registrant has revised page 90 to include a description of the material terms of the Know-How License Agreement and the Know-How License agreement is attached as Exhibit 10.7 to the Registration Statement.

The Registrant has revised pages 79 and 84 to remove statements that imply efficacy of IMC-1.

Our Company, page 74

The Registrant has revised page 82 to include a description of the pain scales used in the studies.

Background of Fibromyalgia (FM), page 77

The Registrant has revised page 86 to clarify that based on estimates up to 21 million people in the U.S. are afflicted with fibromyalgia.

Fibromyalgia: A Serious Condition with Unmet Medical Need, page 79

The Registrant has revised page 77 to include the additional information you requested regarding the PFDD meetings.

The Registrant has revised page 77 to include additional information regarding the internet survey.

Discovery and Development, page 82

The Registrant has revised page 81 relating to the GI biopsy study in accordance with your request.

Adverse Event Report Phase 2a Clinical Study, page 86

86. As this comparison is not based on head-to-head studies, please delete this discussion, or advise.

The Registrant has deleted the head-to-head comparison on page 84.

The Registrant has deleted the discussion referenced above on page 84.

Regulatory and Development Timeline, page 87

The Registrant has revised page 85 to include a description of the studies and results that will be relied on and the requirements for reliance on the Section 505(b)(2) approval pathway.

The Registrant has revised page 85 and 86 to include a description of the results that the FDA determined warranted further study, such as testicular and kidney toxicity.

Intellectual Property, page 92

The Registrant has revised page 89 to clarify that the patents relate to IMC-1 and the Registrant has provided the additional information requested relating to the Registrant’s foreign patents.

Management, page 104

The Registrant has revised pages 102 to 105 to include the principal occupations and employment during the past five years (or more, if material), including the names and principal business of any corporation or other organization at which he was employed and the information required by Item 401(e)(1).

Board Composition and Election of Directors, page 106

The conversion to a Delaware corporation will occur immediately prior to the effectiveness of the Registration Statement. Consequently, the certificate of incorporation and bylaws will go into effect at that time. The Registrant has revised page 105 to clarify the timing of the corporate conversion and which governing documents will be in effect.

Principal Stockholders, page 118

The Registrant has revised page 118 to identify the natural persons who hold the investment power of the shares held by any entity that holds shares of the Registrant in accordance with the Item 403 of Regulation S-K.

Please contact me at (215) 979-1206 with any questions or further comments regarding the Registrant’s responses to the Staff’s comments.