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
File numbers found in text: 333-236235
Referenced dates: February 28, 2020
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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