# EDGAR Filing Document

**Accession Number:** 0001824293
**File Stem:** 0000000000-23-000567
**Filing Date:** 2023-1
**Character Count:** 26624
**Document Hash:** d61efe6cc026c2fbdc7da0c09298aa40
**Contains OCR:** False
**Source Format:** 

## Filing Content

## Filing Summary
**0000000000-23-000567.hdr.sgml**: 20230425

**ACCESSION NUMBER**: 0000000000-23-000567

**CONFORMED SUBMISSION TYPE**: UPLOAD

**PUBLIC DOCUMENT COUNT**: 2

**FILED AS OF DATE**: 20230119

**FILED FOR**: 

**COMPANY DATA:**
- **COMPANY CONFORMED NAME:** GRI BIO, Inc.
- **CENTRAL INDEX KEY:** 0001824293
- **STANDARD INDUSTRIAL CLASSIFICATION:** PHARMACEUTICAL PREPARATIONS [2834]
- **IRS NUMBER:** 824369909
- **STATE OF INCORPORATION:** DE
- **FISCAL YEAR END:** 1231

**FILING VALUES:**
- **FORM TYPE:** UPLOAD

**BUSINESS ADDRESS:**
- **STREET 1:** 2223 AVENIDA DE LA PLAYA
- **STREET 2:** SUITE 208
- **CITY:** LA JOLLA
- **STATE:** CA
- **ZIP:** 92037
- **BUSINESS PHONE:** (619) 400-1171

**MAIL ADDRESS:**
- **STREET 1:** 2223 AVENIDA DE LA PLAYA
- **STREET 2:** SUITE 208
- **CITY:** LA JOLLA
- **STATE:** CA
- **ZIP:** 92037

**FORMER COMPANY:**
- **FORMER CONFORMED NAME:** Vallon Pharmaceuticals, Inc.
- **DATE OF NAME CHANGE:** 20200910
**PUBLIC REFERENCE ACCESSION NUMBER**: 0001628280-22-032519

## Text-Extract

```

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
FirstName LastName
         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
FirstName LastName
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

```

### Attached PDF Documents

**Attachment 1:** `filename1`

![img-0.jpeg](img-0.jpeg)

CORPORATION FINANCE

# UNITED STATES  
SECURITIES AND EXCHANGE COMMISSION  
WASHINGTON, D.C. 20549

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
Vallon Pharmaceuticals, Inc.
January 19, 2023
Page 2

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
Vallon Pharmaceuticals, Inc.
January 19, 2023
Page 3

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
Vallon Pharmaceuticals, Inc.
January 19, 2023
Page 4

# 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,

Division of Corporation Finance

cc: Faith Charles, Esq.