United States securities and exchange commission logo
May 2, 2022
John Ballard
Chief Financial Officer
Qualis Innovations, Inc.
225 Wilmington West Chester Pike
Suite 200 #145
Chadds Ford, PA 19317
Re: Qualis Innovations,
Inc.
Amendment No. 2 to
Registration Statement on Form S-1
Filed April 20,
2022
File No. 333-260982
Dear Mr. Ballard:
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
February 2, 2022 letter.
Amended Registration Statement on Form S-1 filed April 20, 2022
Cover Page
1. Revise the prospectus
cover page to disclose, if true, that the selling shareholder offering
will commence upon the
termination of the primary offering by the Company. Also revise
to clarify when the
secondary offering will terminate. Refer to Item 501(b)(8) of
Regulation S-K.
Prospectus Summary
Corporate Background, page 2
2. Please disclose here,
as you have on page 30, that you have not finalized development of
John Ballard
Qualis Innovations, Inc.
May 2, 2022
Page 2
your planned SOLACE device and that you have not yet generated any
cash flow from
operations.
If we fail to comply with FDA regulations, our business could suffer, page 15
3. We note your response to prior comment 10 and reissue it. Please
further revise this risk
factor to remove the duplicative information that now appears under
the Business
subsection captioned "Government Regulation".
Government Regulation, page 46
4. We note your disclosure on page 44 stating that you are still
finalizing your SOLACE
product design and have not yet filed a 510(k) application with the
FDA. However, much
of this section remains in the present tense, instead of in the future
tense, and could be
read to imply that your product is further along in the development
process than it actually
is. Please further revise this section to better reflect the current
development status of your
product.
Directors, Executive Officers, Promoters, and Control Persons, page 47
5. We note your response to prior comment 28 and reissue it in part.
Please revise the
disclosure pertaining to your management and board of directors to
include applicable
dates or ranges from which investors can discern the principal
occupations and business
experience of each individual from the past five years. Refer to Item
401(e) of Regulation
S-K.
6. Please revise both your Directors and Officers table and the narrative
disclosure following
it to remove Mr. Bingol, as disclosure on page 27 indicates that he is
no longer involved
with the company as of April 15, 2022.
Executive Compensation, page 50
7. We note your response to prior comment 29 and reissue it in part.
Please revise the
Director Compensation table to remove President from John Ballard's
principal position.
16. Exhibits
Exhibit 23.1, page 61
8. Please request Paris, Kreit & Chiu CPA LLP to revise their consent for
their report with
respect to your financial statements as of December 31, 2020 and
December 31, 2019 to
correct the dual date for those items affected by the restatement
discussed in Note 11.
Exhibits
FirstName LastNameJohn Ballard
Comapany
9. NameQualis
Please Innovations,
move the filing Inc.information from the cover page of
your prospectus to a
fee-related
May 2,separate exhibit
2022 Page 2 document. Refer to Item 601(b)(107) of Regulation S-K.
FirstName LastName
John Ballard
FirstName LastNameJohn
Qualis Innovations, Inc. Ballard
Comapany
May 2, 2022NameQualis Innovations, Inc.
May 2,
Page 3 2022 Page 3
FirstName LastName
General
10. We reissue prior comment 42. Please further revise your prospectus to
remove any plural
references to your "products," "proposed products," and "product
candidates" as
disclosure on page 3 indicates that SOLACE is your sole product.
You may contact Tracey Houser at 202-551-3736 or Jeanne Baker at
202-551-3691 if
you have questions regarding comments on the financial statements and related
matters. Please
contact Tyler Howes at 202-551-3370 or Christopher Edwards at 202-551-6761 with
any other
questions.
Sincerely,
Division of
Corporation Finance
Office of Life
Sciences
cc: Lance Brunson