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SEC Company Response from AIxCrypto Holdings, Inc. (AIXC) (CIK 0001460702) (FFR) — Mar 13, 2020

AIxCrypto Holdings, Inc. (AIXC) (CIK 0001460702)
Date: March 13, 2020 · CIK: 0001460702 · Accession: 0001493152-20-003951

AI Filing Summary & Sentiment

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File numbers found in text: 333-236235

Referenced dates: February 28, 2020

Date
March 13, 2020
Author
Not clearly detected
Form
CORRESP
Company
AIxCrypto Holdings, Inc. (AIXC) (CIK 0001460702)

Letter

VIA EDGAR Securities and Exchange Commission Division of Corporation Finance Re: Ritter Pharmaceuticals, Inc. Registration Statement on Form S-4 Filed February 4, 2020 File No. 333-236235

Dear Ms. Sarmento and Ms. Murphy:

On behalf of our client, Ritter Pharmaceuticals, Inc. (“Ritter” or the “Company”), we submit this letter in response to comments from the staff (the “Staff”) of the Securities and Exchange Commission (the “Commission”) contained in its letter dated February 28, 2020 (the “Comment Letter”), relating to the above-referenced Registration Statement on Form S-4 (the “Registration Statement”). We are concurrently filing via EDGAR this letter and Amendment No. 1 to the Registration Statement (the “Amended Registration Statement”).

Set forth below in bold are comments from the Comment Letter. For your convenience, each of the numbered paragraphs below corresponds to the numbered comment in the Staff’s Comment Letter and includes the caption used in the Comment Letter. Immediately following each comment is the Company’s response to that comment, including, where applicable, a cross-reference to the location of changes made in the Amended Registration Statement in response to the Staff’s comment. All page references in the responses set forth below refer to page numbers in the Amended Registration Statement. Defined terms used but not otherwise defined herein have the meanings ascribed to such terms in the Amended Registration Statement.

Registration Statement on Form S-4

Questions and Answers about the Merger

Q: What is the Pre-Closing Qualigen Financing?, page 12

1.

Please file the financing commitment letter as an exhibit or tell us why you don’t believe it’s necessary.

The Company acknowledges the Staff’s comment and respectfully advises the Staff that it has filed the financing commitment letter and will also file (by amendment) an amendment to the financing commitment letter recently entered into as exhibits to the Amended Registration Statement.

Securities and Exchange Commission

March 13, 2020

Page 2

Risks Related to Qualigen

Qualigen relies on its distribution partner Sekisui, page 54

2.

Please file the distribution agreement with Sekisui as an exhibit or tell us why you don’t believe it’s necessary.

The Company acknowledges the Staff’s comment and respectfully advises the Staff that it has filed the distribution agreement with Sekisui as an exhibit to the Amended Registration Statement.

Background of the Transaction, page 93

3.

We note your disclosure that, beginning on October 7, 2019, Ritter management consulted with certain members of the Ritter Board on two occasions and following such consultations, selected a subset of candidates to progress to in-person presentations and to receive an initial draft of a letter of intent, respectively. Please disclose which members of the Ritter Board were consulted on both occasions and what criteria was used to determine the two subsets of candidates.

The Company acknowledges the Staff’s comment and respectfully advises the Staff that it has revised the disclosures in the Amended Registration Statement to provide the information requested by this comment.

4.

We note your disclosure that members of the Transaction Committee received copies of the full proposals submitted by Party B, Party C and Party D and a summary of each of the 13 proposals submitted to AGP, including Qualigen’s proposal, on October 26, 2019. Please disclose who determined to provide full copies of only three proposals and how that determination was made.

The Company acknowledges the Staff’s comment and respectfully advises the Staff that it has revised the disclosures in the Amended Registration Statement to provide the information requested by this comment.

Securities and Exchange Commission

March 13, 2020

Page 3

5.

We note your disclosure that the Transaction Committee directed Ritter management to continue to explore a potential transaction with each of Qualigen and Parties A, B, C, D, E and F on October 30, 2019, but Qualigen was informed that Ritter would be pursing an alternative transaction and would not be pursuing a transaction with Qualigen on November 1, 2019. Please disclose what transpired between October 30, 2019 and November 1, 2019 to change the Transaction Committee’s decision and what factors were considered. Please also revise to disclose the material terms of the bids from Qualigen and Parties A, B, C, D, E and F. To the extent that you have not already done so, please disclose how the material terms of the Qualigen bid were negotiated, including how the deal value, pricing mechanism, exchange ratio and ownership split were negotiated.

The Company acknowledges the Staff’s comment and respectfully advises the Staff that it has revised the disclosures in the Amended Registration Statement to provide the information requested by this comment.

6. Please disclose what parts of the proposals from Parties B, C and D led the Transaction Committee to determine that Parties B, C and D were the candidates the most likely to have the ability to consummate a merger with Ritter within a compressed timeframe and on terms most likely to maximize shareholder value. Please also discuss whether Ritter considered reaching out to the other parties who submitted proposals to see whether they could make their offers more competitive.

The Company acknowledges the Staff’s comment and respectfully advises the Staff that it has revised the disclosures in the Amended Registration Statement to provide the information requested by this comment.

7. We note your disclosure that AGP conducted a valuation analysis of each proposal. Please expand your disclosure to describe the analyses performed, including comparables selected for evaluation, the assumptions underlying such analyses and the resulting valuation or valuation range resulting from the analyses.

The Company acknowledges the Staff’s comment and respectfully advises the Staff that it has revised the disclosures in the Amended Registration Statement to provide the information requested by this comment.

Ritter Business, page 151

8. We note your disclosure on page 39 that Ritter may continue to seek partnering, collaborative or similar strategic arrangements with third parties to develop and commercialize RP-G28 either as a prescription drug or OTC product or as a dietary supplement if the merger is not completed. Please disclose in this section if the combined company has any plans for RP-G28 if the merger is completed.

The Company acknowledges the Staff’s comment and respectfully advises the Staff that it has revised the disclosures in the Amended Registration Statement to explain that the combined company does not intend to continue the clinical development of RP-G28 and will look to sell, license or transfer the RP-G28 assets.

Securities and Exchange Commission

March 13, 2020

Page 4

9. Please remove statements in this section that RP-G28 could become the first drug approved by the FDA for the treatment of LI if approved and RP-G28 was expected to have the potential to become the first FDA-approved drug for the reduction of symptoms associated with LI. Since you disclose that all further development efforts for RP-G28 have been suspended, it is not appropriate to make these statements. Please also remove the statement that clinical testing demonstrated that Lactagen was an effective and safe product for reducing symptoms for nearly 80% of the clinical participants who were on Lactagen. Determinations of safety and efficacy are solely within the authority of the FDA, and and it appears that Lactagen never received FDA approval.

The Company acknowledges the Staff’s comment and respectfully advises the Staff that it has revised the disclosures in the Amended Registration Statement to remove these statements.

Galacto-oligosaccharides (GOS), page 153

10.

Please revise Figure 1 on page 154 to better differentiate the control, glucose, GOS1 and GOS2 lines.

The Company acknowledges the Staff’s comment and respectfully advises the Staff that it has included a new Figure 1 in the Amended Registration Statement that better differentiates the control, glucose, GOS1 and GOS2 lines.

Qualigen’s Business

Products and Solutions, page 169

11.

We note your disclosure here that your products have been shown preclinically to have the potential to work together, alone or in combination with other therapies, multiplying their effectiveness. Please remove any reference to effectiveness for product candidates which have yet to receive FDA approval, and please do not refer to such product candidates as “products.” Similarly, please remove any references to increased potency in preclinical studies for ALAN on page 170. Determinations of efficacy are solely within the authority of the FDA.

The Company acknowledges the Staff’s comment and respectfully advises the Staff that it has revised the disclosures in the Amended Registration Statement to remove these statements.

12.

We note references to preclinical studies here and on page 170. To the extent that you reference preclinical data suggestive of the potential of your product candidates, please revise to discuss the studies and present the data supporting your statements.

The Company acknowledges the Staff’s comment and respectfully advises the Staff that it has revised the disclosures in the Amended Registration Statement to provide the information requested by this comment.

Securities and Exchange Commission

March 13, 2020

Page 5

Overview, page 169

13.

Please make it clear in this section and in the Products and Solutions section that the only product that is currently commercially available is the FastPack System. Please revise to disclose in this section the current stage of development for each of your product candidates: ALAN, RAS-F3 and STARS.

The Company acknowledges the Staff’s comment and respectfully advises the Staff that it has revised the disclosures in the Amended Registration Statement to clarify that the FastPack System is the only product that is currently commercially available and to provide the other information requested by this comment.

ALAN (AS1411-GNP), page 170

14.

Please revise your disclosure of the ULRF License Agreement and ACT License Agreement to provide the royalty term, the duration of the agreement and the termination provisions. We also note your disclosure that Qualigen has agreed to pay ULRF and ACT payments ranging from $100,000 to $5,000,000 upon the achievement of certain milestones. If $5,000,000 is not the aggregate future milestone payments to be made, please revise your disclosure to include that number. Please also file both license agreements as exhibits or tell us why you don’t believe it’s necessary.

The Company acknowledges the Staff’s comment and respectfully advises the Staff that it has revised the disclosures in the Amended Registration Statement to provide the information requested by this comment. The Company has also filed both license agreements as exhibits to the Amended Registration Statement.

Regulatory Strategy, page 171

15.

We note your disclosure that Qualigen has demonstrated success in regulatory affairs, having obtained 17 FDA approvals and 19 CE-Marks for its products to date. Please revise to disclose for which products these approvals and marks have been received and that Qualigen has never received FDA or other regulatory approval for a drug candidate.

The Company acknowledges the Staff’s comment and respectfully advises the Staff that it has revised the disclosures in the Amended Registration Statement to provide the information requested by this comment.

16.

We note your disclosure that your strategy for ALAN will not require Phase 3 trials. Please disclose your basis for this statement and that there is no guarantee that the FDA will not require you to conduct Phase 3 trials for ALAN.

The Company acknowledges the Staff’s comment and respectfully advises the Staff that it has revised the disclosures in the Amended Registration Statement to provide the information requested by this comment and to clarify that there is no guarantee that the FDA will not require Qualigen, Inc. (“Qualigen”) to conduct Phase 3 trials for ALAN.

Securities and Exchange Commission

March 13, 2020

Page 6

Intellectual Property, page 173

17.

Please revise to disclose the specific products, product groups and technologies to which your patents relate, whether they are owned or licensed, the type of patent protection you have, the expiration dates, the applicable jurisdictions and whether there are any contested proceedings or third-party claims.

The Company acknowledges the Staff’s comment and respectfully advises the Staff that it has revised the disclosures in the Amended Registration Statement to provide the information requested by this comment.

Qualigen Management’s Discussion and Analysis of Financial Condition and Results of Operations, page 193

18.

Tell us whether you track any of your R&D costs incurred by program area. If so, tell us your consideration given for disclosing a breakdown of this information in your filing to provide additional context to your R&D activities. If not, tell us your consideration for disclosing the fact that you do not track these costs by pipeline program area and for providing other quantitative or qualitative disclosure that provides transparency as to the types of costs incurred and concentrations of effort expended.

The Company acknowledges the Staff’s comment and respectfully advises the Staff that Qualigen does track R&D costs incurred by program area and the Company has revised its disclosures in the Amended Registration Statement to provide the information requested by this comment.

19.

Revise your MD&A to address the following:

● Discuss the fluctuations in your cost of goods sold, both in terms of dollars as well as percentage of product sales.

● Discuss the extent to which the amounts were affected by changes in your inventory reserves.

● Discuss the reasons for the significant reserves against your inventory, as well as the reasons for the changes in the reserves between periods.

The Company acknowledges the Staff’s comment and respectfully advises the Staff that it has revised the disclosures in the Amended Registration Statement to provide the information requested by this comment.

Unaudited Pro Forma Condensed Combined Financial Statements

Unaudited Pro Forma Condensed Combined Balance Sheet, page 208

Securities and Exchange Commission

March 13, 2020

Page 7

20.

Given that you have determined that Qualigen is the accounting acquirer, revise your pro forma presentations to start with the Qualigen

Show Raw Text
CORRESP
1
filename1.htm

599
Lexington Avenue

New
York, NY 10022-7650

+1
212 521 5400

Fax
+1 212 521 5450

reedsmith.com

March
13, 2020

VIA
EDGAR

Securities
and Exchange Commission

Division
of Corporation Finance

100
F Street, N.E.

Washington,
D.C. 20549

Attn:
Mr. Jeffrey P. Riedler

    Re:
    Ritter
    Pharmaceuticals, Inc.

    Registration
    Statement on Form S-4

    Filed
    February 4, 2020

    File
    No. 333-236235

Dear
Ms. Sarmento and Ms. Murphy:

On
behalf of our client, Ritter Pharmaceuticals, Inc. (“Ritter” or the “Company”), we submit this
letter in response to comments from the staff (the “Staff”) of the Securities and Exchange Commission (the “Commission”)
contained in its letter dated February 28, 2020 (the “Comment Letter”), relating to the above-referenced Registration
Statement on Form S-4 (the “Registration Statement”). We are concurrently filing via EDGAR this letter and Amendment
No. 1 to the Registration Statement (the “Amended Registration Statement”).

Set
forth below in bold are comments from the Comment Letter. For your convenience, each of the numbered paragraphs below corresponds
to the numbered comment in the Staff’s Comment Letter and includes the caption used in the Comment Letter. Immediately following
each comment is the Company’s response to that comment, including, where applicable, a cross-reference to the location of
changes made in the Amended Registration Statement in response to the Staff’s comment. All page references in the responses
set forth below refer to page numbers in the Amended Registration Statement. Defined terms used but not otherwise defined herein
have the meanings ascribed to such terms in the Amended Registration Statement.

Registration
Statement on Form S-4

Questions
and Answers about the Merger

Q:
What is the Pre-Closing Qualigen Financing?, page 12

    1.

    Please
    file the financing commitment letter as an exhibit or tell us why you don’t believe it’s necessary.

    The
    Company acknowledges the Staff’s comment and respectfully advises the Staff that it has filed the financing commitment
    letter and will also file (by amendment) an amendment to the financing commitment letter recently entered into as exhibits
    to the Amended Registration Statement.

    Securities and Exchange Commission

March
                                         13, 2020

Page 2

Risks
Related to Qualigen

Qualigen
relies on its distribution partner Sekisui, page 54

    2.

    Please
    file the distribution agreement with Sekisui as an exhibit or tell us why you don’t believe it’s necessary.

    The
    Company acknowledges the Staff’s comment and respectfully advises the Staff that it has filed the distribution agreement
    with Sekisui as an exhibit to the Amended Registration Statement.

Background
of the Transaction, page 93

    3.

    We
    note your disclosure that, beginning on October 7, 2019, Ritter management consulted with certain members of the Ritter Board
    on two occasions and following such consultations, selected a subset of candidates to progress to in-person presentations
    and to receive an initial draft of a letter of intent, respectively. Please disclose which members of the Ritter Board were
    consulted on both occasions and what criteria was used to determine the two subsets of candidates.

    The
    Company acknowledges the Staff’s comment and respectfully advises the Staff that it has revised the disclosures
    in the Amended Registration Statement to provide the information requested by this comment.

    4.

    We
    note your disclosure that members of the Transaction Committee received copies of the full proposals submitted by Party B,
    Party C and Party D and a summary of each of the 13 proposals submitted to AGP, including Qualigen’s proposal, on October
    26, 2019. Please disclose who determined to provide full copies of only three proposals and how that determination was made.

    The
    Company acknowledges the Staff’s comment and respectfully advises the Staff that it has revised the disclosures
    in the Amended Registration Statement to provide the information requested by this comment.

    Securities and Exchange Commission

March
                                         13, 2020

Page 3

    5.

    We
    note your disclosure that the Transaction Committee directed Ritter management to continue to explore a potential transaction
    with each of Qualigen and Parties A, B, C, D, E and F on October 30, 2019, but Qualigen was informed that Ritter would be
    pursing an alternative transaction and would not be pursuing a transaction with Qualigen on November 1, 2019. Please disclose
    what transpired between October 30, 2019 and November 1, 2019 to change the Transaction Committee’s decision and what
    factors were considered. Please also revise to disclose the material terms of the bids from Qualigen and Parties A, B, C,
    D, E and F. To the extent that you have not already done so, please disclose how the material terms of the Qualigen bid were
    negotiated, including how the deal value, pricing mechanism, exchange ratio and ownership split were negotiated.

    The
    Company acknowledges the Staff’s comment and respectfully advises the Staff that it has revised the disclosures
    in the Amended Registration Statement to provide the information requested by this comment.

    6.
    Please
    disclose what parts of the proposals from Parties B, C and D led the Transaction Committee to determine that Parties B, C
    and D were the candidates the most likely to have the ability to consummate a merger with Ritter within a compressed timeframe
    and on terms most likely to maximize shareholder value. Please also discuss whether Ritter considered reaching out to the
    other parties who submitted proposals to see whether they could make their offers more competitive.

    The
    Company acknowledges the Staff’s comment and respectfully advises the Staff that it has revised the disclosures
    in the Amended Registration Statement to provide the information requested by this comment.

    7.
    We
    note your disclosure that AGP conducted a valuation analysis of each proposal. Please expand your disclosure to describe the
    analyses performed, including comparables selected for evaluation, the assumptions underlying such analyses and the resulting
    valuation or valuation range resulting from the analyses.

    The
    Company acknowledges the Staff’s comment and respectfully advises the Staff that it has revised the disclosures
    in the Amended Registration Statement to provide the information requested by this comment.

Ritter
Business, page 151

    8.
    We
    note your disclosure on page 39 that Ritter may continue to seek partnering, collaborative or similar strategic arrangements
    with third parties to develop and commercialize RP-G28 either as a prescription drug or OTC product or as a dietary supplement
    if the merger is not completed. Please disclose in this section if the combined company has any plans for RP-G28 if the merger
    is completed.

    The
    Company acknowledges the Staff’s comment and respectfully advises the Staff that it has revised the disclosures
    in the Amended Registration Statement to explain that the combined company does not intend to continue the clinical development
    of RP-G28 and will look to sell, license or transfer the RP-G28 assets.

    Securities and Exchange Commission

March
                                         13, 2020

Page 4

    9.
    Please
    remove statements in this section that RP-G28 could become the first drug approved by the FDA for the treatment of LI if approved
    and RP-G28 was expected to have the potential to become the first FDA-approved drug for the reduction of symptoms associated
    with LI. Since you disclose that all further development efforts for RP-G28 have been suspended, it is not appropriate to
    make these statements. Please also remove the statement that clinical testing demonstrated that Lactagen was an effective
    and safe product for reducing symptoms for nearly 80% of the clinical participants who were on Lactagen. Determinations of
    safety and efficacy are solely within the authority of the FDA, and and it appears that Lactagen never received FDA approval.

    The
    Company acknowledges the Staff’s comment and respectfully advises the Staff that it has revised the disclosures
    in the Amended Registration Statement to remove these statements.

Galacto-oligosaccharides
(GOS), page 153

    10.

    Please
    revise Figure 1 on page 154 to better differentiate the control, glucose, GOS1 and GOS2 lines.

    The
    Company acknowledges the Staff’s comment and respectfully advises the Staff that it has included a new Figure 1 in the
    Amended Registration Statement that better differentiates the control, glucose, GOS1 and GOS2 lines.

Qualigen’s
Business

Products
and Solutions, page 169

    11.

    We
    note your disclosure here that your products have been shown preclinically to have the potential to work together, alone or
    in combination with other therapies, multiplying their effectiveness. Please remove any reference to effectiveness for product
    candidates which have yet to receive FDA approval, and please do not refer to such product candidates as “products.”
    Similarly, please remove any references to increased potency in preclinical studies for ALAN on page 170. Determinations of
    efficacy are solely within the authority of the FDA.

    The
    Company acknowledges the Staff’s comment and respectfully advises the Staff that it has revised the disclosures
    in the Amended Registration Statement to remove these statements.

    12.

    We
    note references to preclinical studies here and on page 170. To the extent that you reference preclinical data suggestive
    of the potential of your product candidates, please revise to discuss the studies and present the data supporting your statements.

    The
    Company acknowledges the Staff’s comment and respectfully advises the Staff that it has revised the disclosures
    in the Amended Registration Statement to provide the information requested by this comment.

    Securities and Exchange Commission

March
                                         13, 2020

Page 5

Overview,
page 169

    13.

    Please
    make it clear in this section and in the Products and Solutions section that the only product that is currently commercially
    available is the FastPack System. Please revise to disclose in this section the current stage of development for each of your
    product candidates: ALAN, RAS-F3 and STARS.

    The
    Company acknowledges the Staff’s comment and respectfully advises the Staff that it has revised the disclosures
    in the Amended Registration Statement to clarify that the FastPack System is the only product that is currently commercially
    available and to provide the other information requested by this comment.

ALAN
(AS1411-GNP), page 170

    14.

    Please
    revise your disclosure of the ULRF License Agreement and ACT License Agreement to provide the royalty term, the duration of
    the agreement and the termination provisions. We also note your disclosure that Qualigen has agreed to pay ULRF and ACT payments
    ranging from $100,000 to $5,000,000 upon the achievement of certain milestones. If $5,000,000 is not the aggregate future
    milestone payments to be made, please revise your disclosure to include that number. Please also file both license agreements
    as exhibits or tell us why you don’t believe it’s necessary.

    The
    Company acknowledges the Staff’s comment and respectfully advises the Staff that it has revised the disclosures
    in the Amended Registration Statement to provide the information requested by this comment. The Company has also filed both
    license agreements as exhibits to the Amended Registration Statement.

Regulatory
Strategy, page 171

    15.

    We
    note your disclosure that Qualigen has demonstrated success in regulatory affairs, having obtained 17 FDA approvals and 19
    CE-Marks for its products to date. Please revise to disclose for which products these approvals and marks have been received
    and that Qualigen has never received FDA or other regulatory approval for a drug candidate.

    The
    Company acknowledges the Staff’s comment and respectfully advises the Staff that it has revised the disclosures
    in the Amended Registration Statement to provide the information requested by this comment.

    16.

    We
    note your disclosure that your strategy for ALAN will not require Phase 3 trials. Please disclose your basis for this statement
    and that there is no guarantee that the FDA will not require you to conduct Phase 3 trials for ALAN.

    The
    Company acknowledges the Staff’s comment and respectfully advises the Staff that it has revised the disclosures
    in the Amended Registration Statement to provide the information requested by this comment and to clarify that there is no
    guarantee that the FDA will not require Qualigen, Inc. (“Qualigen”) to conduct Phase 3 trials for ALAN.

    Securities and Exchange Commission

March
                                         13, 2020

Page 6

Intellectual
Property, page 173

    17.

    Please
    revise to disclose the specific products, product groups and technologies to which your patents relate, whether they are owned
    or licensed, the type of patent protection you have, the expiration dates, the applicable jurisdictions and whether there
    are any contested proceedings or third-party claims.

    The
    Company acknowledges the Staff’s comment and respectfully advises the Staff that it has revised the disclosures
    in the Amended Registration Statement to provide the information requested by this comment.

Qualigen
Management’s Discussion and Analysis of Financial Condition and Results of Operations, page 193

    18.

    Tell
    us whether you track any of your R&D costs incurred by program area. If so, tell us your consideration given for disclosing
    a breakdown of this information in your filing to provide additional context to your R&D activities. If not, tell us your
    consideration for disclosing the fact that you do not track these costs by pipeline program area and for providing other quantitative
    or qualitative disclosure that provides transparency as to the types of costs incurred and concentrations of effort expended.

    The
    Company acknowledges the Staff’s comment and respectfully advises the Staff that Qualigen does track R&D costs incurred
    by program area and the Company has revised its disclosures in the Amended Registration Statement to provide the information
    requested by this comment.

    19.

    Revise
    your MD&A to address the following:

    ●
    Discuss
    the fluctuations in your cost of goods sold, both in terms of dollars as well as percentage of product sales.

    ●
    Discuss
    the extent to which the amounts were affected by changes in your inventory reserves.

    ●
    Discuss
    the reasons for the significant reserves against your inventory, as well as the reasons for the changes in the reserves between
    periods.

    The
    Company acknowledges the Staff’s comment and respectfully advises the Staff that it has revised the disclosures
    in the Amended Registration Statement to provide the information requested by this comment.

Unaudited
Pro Forma Condensed Combined Financial Statements

Unaudited
Pro Forma Condensed Combined Balance Sheet, page 208

    Securities and Exchange Commission

March
                                         13, 2020

Page 7

    20.

    Given
    that you have determined that Qualigen is the accounting acquirer, revise your pro forma presentations to start with the Qualigen