<SEC-DOCUMENT>0000000000-21-013143.txt : 20241210
<SEC-HEADER>0000000000-21-013143.hdr.sgml : 20241210
<ACCEPTANCE-DATETIME>20211028183005
<PRIVATE-TO-PUBLIC>
ACCESSION NUMBER:		0000000000-21-013143
CONFORMED SUBMISSION TYPE:	UPLOAD
PUBLIC DOCUMENT COUNT:		2
FILED AS OF DATE:		20211028

FILED FOR:		

	COMPANY DATA:	
		COMPANY CONFORMED NAME:			JUPITER NEUROSCIENCES, INC.
		CENTRAL INDEX KEY:			0001679628
		STANDARD INDUSTRIAL CLASSIFICATION:	PHARMACEUTICAL PREPARATIONS [2834]
		ORGANIZATION NAME:           	03 Life Sciences
		IRS NUMBER:				474828381
		STATE OF INCORPORATION:			DE
		FISCAL YEAR END:			1231

	FILING VALUES:
		FORM TYPE:		UPLOAD
		SEC FILE NUMBER:	377-05552

	BUSINESS ADDRESS:	
		STREET 1:		1001 NORTH US HWY 1
		STREET 2:		SUITE 504
		CITY:			JUPITER
		STATE:			FL
		ZIP:			33477
		BUSINESS PHONE:		(561) 406-6154

	MAIL ADDRESS:	
		STREET 1:		1001 NORTH US HWY 1
		STREET 2:		SUITE 504
		CITY:			JUPITER
		STATE:			FL
		ZIP:			33477

	FORMER COMPANY:	
		FORMER CONFORMED NAME:	Jupiter Orphan Therapeutics, Inc.
		DATE OF NAME CHANGE:	20160713
PUBLIC REFERENCE ACCESSION NUMBER:		0001493152-21-024318
</SEC-HEADER>
<DOCUMENT>
<TYPE>LETTER
<SEQUENCE>1
<FILENAME>filename1.pdf
<TEXT>
<PDF>
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United States securities and exchange commission logo





                               October 28, 2021

       Christer Ros  n
       Chief Executive Officer
       Jupiter Neurosciences, Inc.
       1001 North US HWY 1, Suite 504
       Jupiter, Florida 33477

                                                        Re: Jupiter
Neurosciences, Inc.
                                                            Registration
Statement on Form S-1
                                                            Filed on October
12, 2021
                                                            File No. 333-260183

       Dear Mr. Ros  n:

              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-1, Filed on October 12, 2021

       Market, Industry and Other Data, page 5

   1.                                                   We note your statement
that investors are "cautioned not to give undue weight to any such
                                                        information,
projections and estimates." Such statement may imply an inappropriate
                                                        disclaimer of liability
for such third-party information. Please revise to remove any
                                                        implication that
investors are not entitled to rely on information in your registration
                                                        statement.
       Prospectus Summary
       Business Overview, page 6

   2.                                                   We note your disclosure
that you believe JOTROL    is the first and only resveratrol
                                                        product in the world
that delivers a therapeutically effective dose of resveratrol in the
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Jupiter Neurosciences, Inc. Ros  n
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             2021        Neurosciences, Inc.
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         blood stream without causing gastrointestinal (GI) side effects and
that JOTROL    is a
         safe oral medication. Please revise these statements and similar
statements throughout
         your prospectus that state or imply that your product candidates are
safe or effective as
         these determinations are solely within the authority of the U.S. Food
and Drug
         Administration ("FDA") and comparable regulatory bodies. As a
non-exhaustive list for
         illustrative purposes only, we note the following disclosures:

                Page 97:    Overall, the oral administration of JOTROL
(resveratrol) as single
              ascending doses ranging from 200 mg up to 700 mg was safe and
well tolerated in
              healthy adult subjects.
                Page 103:    Studies in mice show that a high dose of
resveratrol is effective in treating
              MPS I.
                Page 106:    These are targets that a high dose of resveratrol
has shown efficacy both
              in pre-clinical work as well as in the well published Turner et
al. trial.
                Pages 109-110:    We believe JOTROLTM will be demonstrated to
be very safe based
              upon the very mild adverse events seen in our Phase I study
..Resveratrol is a natural
              well-known product with a well-documented safety profile with
only gastro-intestinal
              adverse side effects that we believe we have resolved with our
product JOTROLTM.
3.       We note your statement on page 6:    JOTROL   , based on our
pre-clinical and Phase I
         study results, delivers resveratrol into the blood plasma with
significantly greater
         bioavailability than conventional resveratrol and has the ability to
cross the blood-brain
         barrier.    This comparison appears to be based on literature, like
the comparison on page
         97 to the MCR Friedreich   s Ataxia study and Turner et al. Alzheimer
disease study.
         Please remove such comparison and any other comparisons that are not
head-to-head trials
         as comparisons to available products and other product candidates are
not appropriate
         unless you have conducted head-to-head trials. You may generally
discuss the literature
         on the topic in the "Description of Business" section without
comparing it to the results of
         your trials. Additionally, on page 9 you state:    Pre-clinical
testing showed that patented
         technology (JOTROL   ) delivered 17X higher maximum level in plasma (
 C-Max   ) and
         4X higher area under the curve (   AUC   ).    Please revise to
clarify what this is a
         comparison to and provide more details on this study.
4.       We note your statement on page 6:    We plan to continue pursuing
grant funding
         opportunities in all areas where they are available, such as Phase II
and Phase III trials in
         Alzheimer   s disease (up to $75 Million available per project through
NIA /NIH) as well as
         the opportunity in receiving at least 50% of the cost of Phase II and
Phase III trials in rare
         (   orphan   ) diseases.    Please revise the last sentence of the
paragraph in which this
         sentence appears to reflect that you may never receive any future
grants or cost savings.
JOTROL, page 8

5.       On page 8 you say that your Phase 1 pharmacokinetic study will be
cross-referenced for
         all indications where JOTROL    will be used in Phase II and Phase III
clinical trials.
         Similarly, in your pipeline table you state:    A successful Phase II
trial may lead to direct
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Jupiter Neurosciences, Inc. Ros  n
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             2021        Neurosciences, Inc.
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         Phase II/III trial in other mitochondrial rare disease since data can
be referenced.    Please
         revise to state whether you have discussed the use of cross
referencing in this manner with
         the FDA or other comparable regulatory authorities.
Resveratol, page 8

6.       Given that resveratrol has never been approved by the FDA or
comparable regulators to
         treat any of the indications shown, this presentation is speculative
and without context.
         Please revise to remove this graphic.
Product Development, page 9

7.       We note your statement on page 9:    There are often opportunities to
get accelerated FDA
         approval for a rare disease indication if a product shows efficacy and
has a good safety
         profile.    Please revise to describe the FDA pathways you are
referencing in more detail
         and remove the word    often.    Address in your revisions that any
accelerated approval
         pathway designation does not guarantee accelerated FDA review.
Alternatively, delete
         this statement.
Product Pipeline, page 9

8.       Please remove the text descriptions under each indication in the
pipeline table on page 9
         and elsewhere. Each one sentence description requires more context
that is not appropriate
         for a pipeline table, but can be described outside of the table. For
example, for JNS101,
         describe in the    Description of Business    section what    positive
outcomes    means and
         additional detail such as number of subjects and duration.
Additionally, please tell us why
         you believe JNS109, JNS110 and JNS120 are sufficiently material to be
included in the
         pipeline table considering the early stage of such programs. We note,
for example, your
         statement on page 106 concerning JNS109 where you state:    Our
Co-Chairman of the
         SAB, Professor Rudolph Tanzi, Ph.D., has expertise in this field and
suggested that we
         shall investigate how JOTROLTM can have a positive impact for ALS
patients.    To the
         extent you have taken any concrete actions in the development of these
programs please
         describe them to us in your response.

         You state in the Use of Proceeds section that you intend to use a
portion of the proceeds of
         the offering to "fund IND submissions for Friedereich's ataxia, MELAS
and MCI/early
         Alzheimer's Disease." Where applicable, make clear in the table the
extent to which you
         expect to rely on data from clinical trials conducted by third
parties. Address in the
         narrative the basis for your expectations in this regard.
Selected Historical Financial Data, page 14

9.       Please explain the usefulness of a Gross Profit subtotal when you have
not reported any
         sales or cost of goods sold in any of the periods presented.
Alternatively, please remove
         this subtotal from your Statement of Operations Data.
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Jupiter Neurosciences, Inc. Ros  n
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October  28,NameJupiter
             2021        Neurosciences, Inc.
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Risk Factors
Risks Related to Our Intellectual Property
Our success depends on our ability to protect our intellectual property and our
proprietary
technologies, page 54

10.      Please revise page 54 to highlight your reliance on the Acquanova AG
license agreement
         specifically, including the consequences of the loss of such license.
Use of Proceeds, page 81

11.      We note your statement on page 150:    We intend to pay a portion of
the outstanding
         license fee due to Aquanova AG with our cash balance as of the date of
this filing. We
         project to payout the remaining accrued license fee with proceeds from
this offering.
         Please revise the Use of Proceeds to reflect this use of proceeds.
Dilution, page 89

12.      Please explain to us how you determined your net tangible book value
per share to
         be ($0.15) at June 30, 2021.
Description of Business
Business Overview, page 90

13.      Please describe the material terms of the grant with the National
Institute on Aging.
         Additionally, file such agreement as an exhibit pursuant to Item
601(b)(10) of Regulation
         S-K or advise.
14.      Please describe the agreements with each of your key partners listed
on page 128-129 and
         file such agreements pursuant to Item 601(b)(10) of Regulation S-K, or
advise.
JOTROL Intellectual Property, page 93

15.      With respect to your material patents and patent applications, please
revise to specify (i)
         the specific products, product groups and technologies to which such
patents relate, (ii)
         whether the patents are owned or licensed, (iii) the type of patent
protection, (iv) the
         patent expiration dates and (v) the jurisdiction. Please also explain
the meaning of the
         following sentence on page 93, and, if applicable, the extent to which
your patent
         protection for JOTROL    is incomplete:    The patent application was
assigned to
         Aquanova AG, as Aquanova AG has other patents on their micellar
formulation
         technology that was utilized in creating JOTROL   .
16.      Please revise to describe the material terms of all material license
agreements, including
         the Aquanova AG License Agreement and the MCRI agreement, such as: (i)
the nature
         and scope of intellectual property transferred, (ii) each parties
rights and obligations, (iii)
         the duration of the agreement and royalty term, (iv) the termination
provisions, (v) any up-
         front or execution payments, (vi) the aggregate amounts paid to date,
(vii) the aggregate
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Jupiter Neurosciences, Inc. Ros  n
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         future potential milestone payments segregated by development,
regulatory and
         commercial sales milestones, and (viii) the royalty rates or a royalty
range not to exceed
         ten percentage points per tier. Additionally, please file the Aquanova
AG License
         Agreement and any other material license agreement as an exhibit
pursuant to Item
         601(b)(10) of Regulation S-K.
JOTROL Pre-clinical studies, page 94

17.      With respect to your preclinical studies, please provide additional
detail such as the
         number of studies performed and the number of subjects in each study.
18.      We note the p-values on page 96. Please revise to provide p-values for
all statements of
         statistical significance and explain how statistical significance
relates to FDA standards of
         efficacy.
JOTROL Phase I Pharmacokinetic ("PK") and Safety Study, page 96

19.      Please revise page 97 to clarify the different arms of the PK study
(Treatment A though
         D).
Market Overview, page 98

20.      We note your statement on page 98:    The tables below illustrate how
lucrative just one
         approval in an orphan indication can be. With JNS   s position of
multiple possible
         approval in orphan diseases as well as for Alzheimer   s disease the
Company feels that
         there are many scenarios for generating meaningful treatments for
patients which
         ultimately will lead to financial success.    Please remove these
statements and the
         associated table as they imply you have an increased chance of
obtaining an orphan drug
         designation and approval for at least one candidate, which you then
imply would be
         lucrative. You may describe what an orphan drug designation means and
state that you
         intend to pursue multiple orphan drug designations, but also state
that you may not
         achieve regulatory approval of any of your product candidates.
21.      We note the bar graph on page 99. Given your statement that the
average price for a
         product treating an orphan drug is higher than for a product treating
a non-orphan drug,
         the number of approved orphan drugs generating these sales is smaller
than for non-
         orphan drugs, which is not explained in the graphic. Please revise the
graphic to include
         the number of different types of drugs sold in each year shown.
Alternatively, please
         remove this graphic.
Our Relevant Market Size, page 100

22.      With respect to the rare disease market size calculation on page 100,
please revise to state
         the countries included and name the three indications you refer to.
Additionally, on page
         101 you state:    The Alzheimer   s disease market is very large
evident by the Aduhelm
         pricing of $56,000 per year per patient   We expect our product to be
priced significantly
 Christer Ros  n
Jupiter Neurosciences, Inc.
October 28, 2021
Page 6
         lower if approved for MCI/early AD. We estimate the relevant global
market size for our
         product to be in excess of $100 billion.    Please revise to explain
the basis for your market
         share calculation of over $100 billion.

JNS101 Friedreich's ataxia direct to Phase II, page 102

23.      Please revise to clarify your relationship with MCRI and state whether
you have discussed
         your ability to reference this data with the FDA. Also revise to
provide the p-values for
         "statistically different positive results" on page 102.
JNS102 Phase II trial for MPS I, page 103

24.      On page 103 you state:    IND for Phase I, executed, approved by FDA.
Small FDA
         hurdles to start the Phase II.    Please revise to describe the small
hurdles.
JNS108 Mild Cognitive Impairment/early Alzheimer's Disease, page 105

25.      Please clarify your relationship with Georgetown and whether you have
discussed your
         ability to rely on and reference the Phase II trial conducted by
Georgetown with the FDA.
Competitive Advantages, page 109

26.      Please remove the comparison to Celgene on page 109 which could
inappropriately imply
         that you will also be approved for multiple different indications for
one technology and
         generate billions in annual sales.
27.      Please remove the statement    We also believe that JOTROL    can be
sold at a very
         competitive price and thereby have a stronger possibility of support
from payors    or revise
         to detail all the assumptions you are making regarding pricing. For
example, explain the
         current stage of your manufacturing ability and the extent to which
you can currently
         predict cost of manufacturing on a commercial scale and the
limitations and assumptions
         inherent therein, and explain which payors you are referencing, detail
the basis on which
         you believe payors will support you, and if you are referencing
reimbursement, explain
         how reimbursement works including by detailing all steps you will need
to complete in
         order to obtain reimbursement coverage if regulatory approval is
granted. We note on
         page 110 you state you have    no plans to implement the
commercialization of our product
         JOTROL    but expect to either out-license JOTROL      .
28.    On page 110 you state:    In addition, we were able to receive, from a
major pharmaceutical
FirstName LastNameChrister Ros  n
       company, a full chronic toxicology study performed on resveratrol saving
most likely 1
Comapany
       year NameJupiter   Neurosciences,
             in development  time and overInc.
                                            $2 million in cost.    Please
revise to provide the details
Octoberof28,
          this2021
               study in the
                   Page  6 appropriate subsection of the "Description of
Business" section.
FirstName LastName
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FirstName  LastNameChrister
Jupiter Neurosciences, Inc. Ros  n
Comapany
October  28,NameJupiter
             2021        Neurosciences, Inc.
October
Page  7 28, 2021 Page 7
FirstName LastName
Marketing and Commercialization Plan, page 110

29.      On page 110 you state:    In cases with no existing available
treatment an approval of a
         breakthrough drug spreads extremely efficient through Key Opinion
Leaders (KOL) and
         patient advocacy groups which may reduce marketing costs.    Please
revise to state that
         this is your belief, if true, or provide support. Additionally, revise
to state that you have
         not applied for breakthrough designation by the FDA, if true. Please
also clarify the
         indications you are referring to as indications "with no existing
available treatment."
Executive Compensation, page 113

30.      Please revise the Summary Compensation Table to include the footnote
required by
         Instruction 1 to Item 402(n)(2)(v) and (n)(2)(vi) of Regulation S-K,
and revise the
         Director Compensation Table to include the footnote required by
Instruction to Item
         402(r)(2)(iii) and (iv) of Regulation S-K.
Management's Discussion and Analysis of Financial Condition and Results of
Operations
Research and Development Expenses, page 114

31.      Please discuss the type of the R&D expense incurred and tell us
whether you track your
         research and development costs by program area. If so, tell us your
consideration given
         for disclosing a breakdown of such information in your filing. If not,
tell us your
         consideration for disclosing the fact you do not track these costs by
pipeline program area.
         In addition, quantify in your narrative discussion of the changes in
such expenses the
         changes due to each program, or if not known, the changes due to
clinical vs non-clinical.
Description of Securities, page 160

32.      Once you have an estimated offering price range, please explain to us
the reasons for any
         differences between recent valuations of your common shares leading up
to the planned
         initial public offering and the midpoint of your estimated offering
price range. This
         information will help facilitate our review of your accounting for
equity issuances,
         including stock compensation.
General

33.      Please provide the undertaking required by Item 512(a)(5) of
Regulation S-K.
34.      Please supplementally provide us with copies of all written
communications, as defined in
         Rule 405 under the Securities Act, that you, or anyone authorized to
do so on your behalf,
         present to potential investors in reliance on Section 5(d) of the
Securities Act, whether or
         not they retain copies of the communications.
        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.
 Christer Ros  n
Jupiter Neurosciences, Inc.
October 28, 2021
Page 8

       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 Christie Wong at 202-551-3684 or Angela Connell at
202-551-3426 if
you have questions regarding comments on the financial statements and related
matters. Please
contact Margaret Schwartz at 202-551-7153 or Christine Westbrook at
202-551-5019 with any
other questions.



                                                           Sincerely,
FirstName LastNameChrister Ros  n
                                                           Division of
Corporation Finance
Comapany NameJupiter Neurosciences, Inc.
                                                           Office of Life
Sciences
October 28, 2021 Page 8
cc:       Craig D. Linder, Esq.
FirstName LastName
</TEXT>
</DOCUMENT>
</SEC-DOCUMENT>
