United States securities and exchange commission logo
January 19, 2023
David Baker
Chief Executive Officer
Vallon Pharmaceuticals, Inc.
Two Logan Square
100 N. 18th Street, Suite 300
Philadelphia, PA 19103
Re: Vallon
Pharmaceuticals, Inc.
Registration
Statement on Form S-4
Filed December 23,
2022
File No. 333-268977
Dear David Baker:
We have reviewed your 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.
Registration Statement on Form S-4 filed December 23, 2022
Cover Page
1. Please prominently
disclose here the expected ownership percentage of Altium Growth
Fund, LP following the
Merger assuming all warrant exercises and receipt of all escrowed
shares as you have done
on pages 2 and 147. Please also make similar revisions
throughout the
prospectus where ownership percentages are disclosed as well as in your
"Equity Financing and
Series T Warrant Exercises" section.
Questions and Answers About the Merger, page 1
2. Please revise your
disclosure in this section, and elsewhere in the prospectus, as
appropriate, to
disclose the status of your conversations with Nasdaq, including the impact
David Baker
FirstName LastNameDavid
Vallon Pharmaceuticals, Inc.Baker
Comapany
January 19,NameVallon
2023 Pharmaceuticals, Inc.
January
Page 2 19, 2023 Page 2
FirstName LastName
that a potential delisting would have on the Merger.
3. Please revise your disclosure in this section, and elsewhere in the
prospectus, as
appropriate, to briefly discuss whether the execution of the Reverse
Split would impact
the percentage of stock owned in the combined company by Vallon s
current stockholders
following the Merger.
4. Please revise your disclosure in this section to include a question
and answer, or multiple
questions and answers, specifically addressing the following points:
Disclose potential exchange ratios at (i) various levels of
Vallon s net cash and (ii)
potential required reductions to Vallon s valuation required in
order to meet Nasdaq s
listing requirements. In your revisions, please show ownership in
the combined
company among GRI s equityholders, Vallon s equityholders and
the Investor.
Disclose whether you anticipate that Vallon s valuation will
need to be reduced in
order to meet the initial listing requirements of Nasdaq, based
upon currently
available information and the current trading price of Vallon s
common stock.
Disclose potential exercise prices of the Series A-1, A-2 and T
Warrants based upon
currently available information, including the potential for
cashless exercises.
Disclose fully-diluted ownership in the combined company,
including the Series A-1,
A-2 and T Warrants.
Q: Who will be the directors of Vallon following the Merger?, page 5
5. When available, please disclose the anticipated directors of the
combined company.
Prospectus Summary
Opinion of Vallon's Financial Advisor, page 15
6. Please revise your disclosure here and throughout the prospectus where
the fairness
opinion is described to reflect your statement on page 103 that, at
the request of the Vallon
Board, for the purposes of its opinion, Ladenburg assumed that no
"Adjustment" (as
defined on page 103) would occur despite management of Vallon advising
Ladenburg
that, as of the date of the opinion, such an Adjustment would be
required. Please also
revise here and on page 103 to explain why the Vallon Board instructed
Ladenburg to
prepare its opinion without incorporating an Adjustment, despite
Vallon's management
advising that an Adjustment would be required.
7. We note your statements here and elsewhere in the prospectus, as well
as in the fairness
opinion attached as Annex G, that the opinion is intended for the sole
benefit of Vallon's
board of directors. Please remove this statement.
Alternatively, please disclose the legal basis for your and
Ladenburg's belief that
stockholders cannot rely on the opinion to bring state law actions,
including a description
of any state law authorities on such a defense. If no such authority
exists, please disclose
that this issue will be resolved by a court, resolution of this issue
will have no effect of on
David Baker
FirstName LastNameDavid
Vallon Pharmaceuticals, Inc.Baker
Comapany
January 19,NameVallon
2023 Pharmaceuticals, Inc.
January
Page 3 19, 2023 Page 3
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rights and responsibilities of Vallon's board under state law and the
availability or non-
availability of this defense has no effect on the rights and
responsibilities of either
Ladenburg or Vallon's board under federal securities laws.
Risk Factors
Litigation relating to the Merger could require Vallon or GRI to incur
significant costs..., page 30
8. Please revise this risk factor to disclose if the parties are aware of
any litigation related the
merger agreement. To the extent the parties are not aware of any
litigation, please include
an affirmative statement to that effect.
The Merger
Background of the Merger, page 93
9. Please revise your disclosure to state why Vallon's management chose
to re-engage in
discussions with Company A in early September ahead of re-engaging in
discussions with
GRI and describe the terms upon which Vallon and Company A were unable
to reach
agreement.
10. We note your statement that changes to GRI's proposal included a
revised budget that
could achieve major milestones with less pending than originally
proposed and a
willingness to revise relative valuation and ownership in the merged
company. Please
quantify both the valuation in GRI's initial proposal and final
valuation attributed to GRI.
To the extent there is a material difference in the initial and final
valuation, include
disclosure explaining the reasoning for such changes. Please also
revise this section to
include a more fulsome discussion of the negotiations of the Exchange
Ratio. Finally,
please revise to describe the details of the revised budget and the
major milestones
included therein.
11. Please revise your disclosure in this section to describe the
discussions and negotiations
with the Investor leading to the Equity Financing.
Vallon Reasons for the Merger, page 97
12. Your disclosure here and on page 14 indicates that the Exchange Ratio
formula is based
on a Vallon valuation of $26.0 million. However, disclosure elsewhere
in the prospectus,
including on page 1, indicates that the Exchange Ratio formula is
based on a Vallon
valuation of $29.0 million. Please reconcile your disclosure or
advise.
Opinion of Vallon's Financial Advisor, page 102
13. We note your disclosure on page 103 that Ladenburg Thalmann & Co. Inc.
reviewed
GRI's projections for purposes of its analyses. Please disclose these
projections and any
"internal financial analyses" upon which Ladenburg Thalmann & Co.
relied to render
its fairness opinion.
David Baker
FirstName LastNameDavid
Vallon Pharmaceuticals, Inc.Baker
Comapany
January 19,NameVallon
2023 Pharmaceuticals, Inc.
January
Page 4 19, 2023 Page 4
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The Merger Agreement
Conditions to the Completion of the Merger, page 137
14. Please revise to clearly identify which conditions the parties may
waive and proceed with
the merger agreement.
Description of GRI's Business, page 167
15. Please revise this section, where appropriate, to include a discussion
of the manufacture
and supply of your product candidates. To the extent material, please
ensure that your
discussion reflects your statement on page 78 that you are reliant on
a sole supplier, or, in
some cases, a limited number of suppliers, for the manufacture of your
product
candidates.
Overview, page 167
16. We note your statement that you are initiating a Phase 1a/1b trial of
GRI-0803 and your
disclosure here and on page 169 that you anticipate topline results
from this trial to be
available in the second quarter of 2024. However, we note that you do
not appear to have
an active IND for this trial. Please refrain from making predictions
that assume successful
clearances of INDs or successful clinical trials. You may state when
you intend to submit
your IND for this trial.
Our Pipeline, page 168
17. Please revise your pipeline table to shorten bar for GRI-0803 as
disclosure on page 180
indicates that you have not yet submitted an IND for this candidate,
or advise. Please also
remove the blue arrows and text from the pipeline arrows. Finally,
based on your
disclosure on pages 54 and 109, neither GRI-0124 nor GRI-0729 is
currently in
development. Please remove these candidates from your pipeline table.
We do not object
to narrative discussion of GRI-0124 and GRI-0729 in the GRI Business
section.
18. Please revise here, or elsewhere in the Business section, as
appropriate, to discuss in
further detail the results from your pilot Phase 2a trial of GRI-0621,
including whether the
trial achieved its endpoints, the frequency and nature of any observed
adverse events and
if adverse events were linked to treatment.
Description of Vallon Capital Stock
Choice of Forum, page 255
19. Please include a risk factor discussing the risks to investors arising
from the Choice of
Forum provision of Vallon's certificate of incorporation. Risks may
include, but are not
limited to, increased costs to bring a claim and that these provisions
can discourage claims
or limit investors' ability to bring a claim in a judicial forum that
they find
favorable. Please also disclose whether this provision applies to
actions arising under the
Securities Act. In that regard, we note that Section 22 of the
Securities Act creates
David Baker
Vallon Pharmaceuticals, Inc.
January 19, 2023
Page 5
concurrent jurisdiction for federal and state courts over all suits
brought to enforce any
duty or liability created by the Securities Act or the rules and
regulations thereunder. If
the provision applies to Securities Act claims, please also revise your
disclosure to state
that there is uncertainty as to whether a court would enforce such
provision and that
investors cannot waive compliance with the federal securities laws and
the rules and
regulations thereunder. If this provision does not apply to actions
arising under the
Securities Act, please also ensure that the Choice of Forum provision in
the certificate of
incorporation states this clearly, or tell us how you will inform
investors in future filings
that the provision does not apply to any actions arising under the
Securities Act.
Exhibits
20. Please file the consent of Ladenburg Thalmann & Co. Inc. as an exhibit to
this registration
statement. For guidance, refer to Item 601 of Regulation S-K.
We remind you that the company and its management are responsible for
the accuracy
and adequacy of their disclosures, notwithstanding any review, comments, action
or absence of
action by the staff.
Refer to Rules 460 and 461 regarding requests for acceleration. Please
allow adequate
time for us to review any amendment prior to the requested effective date of
the registration
statement.
You may contact Tara Harkins at 202-551-3639 or Daniel Gordon at
202-551-3486 if
you have questions regarding comments on the financial statements and related
matters. Please
contact Tyler Howes at 202-551-3370 or Alan Campbell at 202-551-4224 with any
other
questions.
Sincerely,
FirstName LastNameDavid Baker
Division of
Corporation Finance
Comapany NameVallon Pharmaceuticals, Inc.
Office of Life
Sciences
January 19, 2023 Page 5
cc: Faith Charles, Esq.
FirstName LastName