United States securities and exchange commission logo
August 11, 2022
Heng Fai Ambrose Chan
Chief Executive Officer
Impact BioMedical, Inc.
275 Wiregrass Pkwy
West Henrietta, NY 14586
Re: Impact BioMedical,
Inc.
Amendment No. 4 to
Registration Statement on Form S-1
Filed August 2,
2022
File No. 333-253037
Dear Mr. Chan:
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 July
21, 2022 letter.
Amendment No. 4 to Form S-1 filed August 2, 2022
Summary
Business Overview, page 2
1. We note your response
to our prior comment 1 and reissue in part. Please expand your
Summary to provide
examples of material risks and uncertainties that are specific to your
business. Please
include the following:
that you cannot
guarantee that you will find third-parties or customers that are
interested in
purchasing, licensing, or co-developing these products;
that even if you
are able to establish licensing arrangements, that you cannot
guarantee that the
licensor will be successful in their development efforts;
Heng Fai Ambrose Chan
Impact BioMedical, Inc.
August 11, 2022
Page 2
that you cannot guarantee that these products will ever be
approved for clinical
testing or commercialization by the FDA;
that you have not yet generated any revenue from your
operations; and
information regarding your history of net losses, negative
class flows, and
accumulated deficit over the last two years.
2. We have reviewed your revisions and response to our prior comment 2.
In your response
you state that DSS PureAir, Inc. is not a subsidiary of the company,
but in Note 4 to your
financial statements for the quarter ended March 31, 2022 you indicate
that DSS PureAir,
Inc. is a wholly owned subsidiary of the company. Please reconcile
your response with
your disclosure and revise your disclosure as appropriate, including
revising your
subsidiary chart. We also note your disclosure in Note 4 that
subsequent to the execution
of the promissory note that DSS PureAir, Inc. entered into a
distribution agreement with
the Borrower. Please revise your disclosure to clarify the current
status and role of DSS
PureAir, Inc. in your company.
3. We note your response to our prior comment 4 and reissue. To the
extent that VanXin,
Quantum, and CRST 1 are material to your business, please expand your
disclosure in
your Business section to provide a more fulsome discussion of these
program and a
description of development activities conducted. In your description
of each product,
please discuss the mechanism of action, the development activities you
have conducted,
and the remaining steps to commercialize the product. Alternatively,
please remove these
programs from your Summary on page 4.
4. We note your revision in response to our prior comment 5 and reissue.
There are still
statements of efficacy throughout your disclosure. For example only
and without
limitation, we note your statement on page 4 that "The testing for
CRST 1 has been
completed to prove its effectiveness as a cancer inhibiting agent" and
your statements on
pages F-8 and F-22 that "Equivir is a patented medication, that has
broad antiviral efficacy
against multiple types of infectious disease." Efficacy and safety are
determinations that
are solely within the authority of the FDA. Please remove these and
all other statements
of efficacy.
Management's Discussion and Analysis of Financial Condition and Results of
Operations
Fiscal Year Ended December 31, 2021, compared to Year Ended December 31, 2020
Income tax benefit, page 24
5. We note from your revised disclosures in response to prior comment 11
that the increase
in your income tax benefit is a direct result of the increase in loss
from operations for the
year. Given your disclosures on page F-15 that you believe that it is
probable that the
FirstName LastNameHeng Fai Ambrose Chan
Company would not use tax assets in the near future, please explain why
you have not
Comapany NameImpact
recorded BioMedical,
a full valuation Inc. on your deferred tax assets. Please
tell us how you
allowance
Augustconsidered the guidance
11, 2022 Page 2 of ASC paragraphs 740-10-30-21 to 23.
FirstName LastName
Heng Fai Ambrose Chan
FirstName LastNameHeng
Impact BioMedical, Inc. Fai Ambrose Chan
Comapany
August 11, NameImpact
2022 BioMedical, Inc.
August
Page 3 11, 2022 Page 3
FirstName LastName
Business, page 27
6. We note your response to our prior comment 14 and reissue. Given the
early stage of
these products, these claims appear speculative. Please provide
context and support to
explain your basis for the claims that "natural compounds used in the
Linebacker platform
have demonstrated strong potential in treating and preventing a range
of diseases . . ." and
that "use of Laetose in a daily diet, compared to sugar, could result
in 30% less sugar
consumption and lower glycemic index/load." Please also describe any
discovery
activities you have conducted for these and your other product
candidates. To the extent
that these claims are the opinions or belief of management, please
revise your statements
to clearly characterize them as such and provide appropriate support
for these
opinions/beliefs.
Equivir, page 30
7. We note your response to our prior comment 16. Please revise your
disclosure to provide
the basis for your belief regarding the potential mechanism of action
for Equivir.
GRDG Licensing Proceeds Distribution Agreement, page 32
8. We note your revisions in response to our prior comment 24 and reissue
in part. We note
that the GRDG Licensing Proceeds Distribution Agreement provides for
monthly
"Consulting Payments" of $43,325.68 and certain termination
provisions. Please expand
your description of the GRDG agreement to disclose the Consulting
Payments, the
aggregate amount of payments that Impact has made to date under this
agreement, and the
termination provisions. Please also make clear in your description of
this agreement and
the Global BioLife Stockholders' Agreement that the $43,000 payments
to GRDG are the
same, singular payment obligation.
Intellectual Property, page 35
9. We note your revisions in response to our prior comment 18, including
your statement that
the expiration date of pending patents typically approximate 20 years
from filing. For
each of your pending patents, please disclose the date that you filed
your patent
application for each jurisdiction in which you filed. The timeframe in
which your
intellectual property protections, granted and pending, expire is
material to investors.
Item 11 - Change in Auditors, page 48
10. We note your revisions in response to our prior comment 21. Please
file a letter from your
former accountant stating whether it agrees with the statements you
made in response to
this Item. Refer to Item 304(a)(3) and Item 601(b)(16) of Regulation
S-K.
Heng Fai Ambrose Chan
Impact BioMedical, Inc.
August 11, 2022
Page 4
You may contact Eric Atallah at 202-551-3663 or Mary Mast at
202-551-3613 if you
have questions regarding comments on the financial statements and related
matters. Please
contact Jordan Nimitz at 202-551-5831 or Tim Buchmiller at 202-551-3635 with
any other
questions.
Sincerely,
FirstName LastNameHeng Fai Ambrose Chan
Division of
Corporation Finance
Comapany NameImpact BioMedical, Inc.
Office of Life
Sciences
August 11, 2022 Page 4
cc: Darrin M. Ocasio, Esq.
FirstName LastName