July 19, 2019
John Kollins
President and Chief Executive Officer
Satsuma Pharmaceuticals, Inc.
400 Oyster Point Boulevard, Suite 221
South San Francisco, CA 94080
Re: Satsuma Pharmaceuticals, Inc.
Draft Registration Statement on Form S-1
Submitted June 21, 2019
CIK No. 0001692830
Dear Mr. Kollins:
We have reviewed your draft 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 providing the requested information and
either submitting
an amended draft registration statement or publicly filing your registration
statement on
EDGAR. 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 the information you provide in response to these comments
and your
amended draft registration statement or filed registration statement, we may
have additional
comments.
Draft Registration Statement on Form S-1 submitted June 21, 2019
Prospectus Summary
Overview, page 1
1. We note your statements throughout the prospectus that you believe
STS101 has the
potential to be a "best-in-class" acute treatment for migraine. This
term suggests that your
product candidate is effective, likely to be approved and compares
favorably to
competitive products. It is premature and inappropriate for you to make
such statements
or implications. Accordingly, please delete all references throughout
your registration
statement to STS101 as having the potential to become a best-in-class
therapy. If you
wish to distinguish STS101 from other acute treatments for migraine that
are marketed or
are being developed for your target indication, such disclosure should
be accompanied by
John Kollins
FirstName LastNameJohn Inc.
Satsuma Pharmaceuticals, Kollins
Comapany NameSatsuma Pharmaceuticals, Inc.
July 19, 2019
July 19, 2019 Page 2
Page 2
FirstName LastName
cautionary language that the statements are not intended to give any
indication that your
product candidate has been proven effective or that it will receive
regulatory approval.
2. We note the disclosure that STS101 was designed to be "effective" and
"safe." As your
product candidate has not received FDA approval, it is premature to
suggest or imply that
it is safe or effective. Please revise your disclosure here and any
similar statements
throughout the prospectus accordingly.
3. We refer to the graphs on page 93 which indicate that DHE mesylate IM
injection
demonstrated higher plasma concentration than your STS101 candidate.
Accordingly,
please revise to balance the Summary presentation by clarifing how
your product
compares to the IM injection alternative. For instance, we refer to
disclosures on page
2 indicating that (i) STS101 has a number of key attributes that you
believe may provide
significant advantages over existing acute treatments for migraine and
(ii) DHE exposure
levels following STS101 administration exceeded or fell within ranges
that previously
have demonstrated efficacy with other dosage forms of DHE.
4. Please revise the Prospectus Summary to explain that you rely on a
license from SNBL to
develop and commercialize STS101. With reference to your January 5,
2017 press
release, "Satsuma Pharmaceuticals Spins Out from Shin Nippon
Biomedical Laboratories
(SNBL) with Funding from Leading Institutional Life Science
Investors," it also should be
clear from your Summary disclosure that were an SNBL subsidiary at the
time that SNBL
granted you the original June 2016 license.
5. Please revise the disclosure on page 2 to explain briefly the term
"drug exposure." From
your disclosure, it should be clear how this measure differs from
plasma concentration.
Implications of Being an Emerging Growth Company, page 4
6. 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.
Risk Factors
STS101 may cause undesirable side effects or have other properties that could
delay..., page 19
7. We note your disclosure that unless you can successfully demonstrate
by conducting a
drug-drug interaction study that the coadministration of DHE and
certain other drugs does
not result in inhibition of DHE metabolism and elevated DHE levels,
the FDA is likely to
require a "black box" warning in your label for STS101, which could
result in STS101 not
achieving its full commercial potential. Please revise your "DHE"
disclosure on page 88
and your Development Plan disclosures on pages 96-98 to discuss side
effects associated
with DHE use and your development plans, if any, to conduct drug-drug
interaction
studies.
John Kollins
Satsuma Pharmaceuticals, Inc.
July 19, 2019
Page 3
Our amended and restated certificate of incorporation and amended and restated
bylaws will
provide for an exclusive forum..., page 59
8. We note that your forum selection provision identifies the Court of
Chancery of the State
of Delaware as the exclusive forum for certain litigation, including
any "derivative
action." Please disclose here and on pages 144-145 whether this
provision applies to
actions arising under the Securities Act or Exchange Act. In that
regard, we note that
Section 27 of the Exchange Act creates exclusive federal jurisdiction
over all suits brought
to enforce any duty or liability created by the Exchange Act or the
rules and regulations
thereunder, and Section 22 of the Securities Act creates 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 prospectus to
specifically 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. To the extent the provision does not apply to claims
arising under the
Securities Act and the Exchange Act, please ensure the exclusive forum
provision in your
governing documents states this clearly.
Use of Proceeds, page 63
9. We note that you intend to use the net proceeds from this offering to
fund your Phase 3
EMERGE efficacy trial and your Phase 3 safety trial for STS101 and to
further develop
STS101. Please revise your disclosure to specify whether additional
funds will be
necessary to complete the two clinical trials you identify. If a
material amount of other
funds is necessary to complete these trials, state the amounts and
sources of such other
funds. Refer to Instruction 3 of Item 504 of Regulation S-K.
DHE, page 88
10. We note that your disclosures on pages 2 and 90 compare your STS101
product to
Migranal and intravenous-delivered DHE by referencing plasma
concentration levels in
terms of variability, rapidity, and high peak measurement. Based on
these disclosures and
others, it appears that these three factors/measures may impact DHE's
therapeutic
response but also may be associated with negative side effects.
Accordingly, please revise
appropriate sections of your Business discussion to explain the
significance of DHE
plasma concentration as it relates to therapeutic response and side
effects. From your
FirstName LastNameJohn Kollins be clear how your STS101 product compares to
Migranal
revised disclosures, it should
Comapany to IV delivered Pharmaceuticals, Inc.variability, rapidity, and high
peak measurements
and NameSatsuma DHE in terms of the
July 19, 2019 Page DHE plasma concentrations.
of recorded 3
FirstName LastName
John Kollins
FirstName LastNameJohn Inc.
Satsuma Pharmaceuticals, Kollins
Comapany NameSatsuma Pharmaceuticals, Inc.
July 19, 2019
July 19, 2019 Page 4
Page 4
FirstName LastName
Our Solution: STS101 for the Acute Treatment of Migraine, page 89
11. We note your disclosure concerning the STS101 development work that
SNBL conducted
over more than 15 years. Please revise here and elsewhere, as
applicable, to clarify
whether Satsuma has engaged in any product development efforts since
the spin-off and
indicate whether any such development efforts are on-going.
12. With reference to your disclosure in the penultimate paragraph on page
90, please revise
the Business section to explain the favorable stability properties
that STS101 dry-
powder formulation has demonstrated.
Business
Safety and Tolerability, page 93
13. Your disclosure indicates that subjects treated with STS101 reported a
higher frequency of
nasal adverse events than those treated with DHE mesylate IM injection
or Migranal DHE
mesylate liquid nasal spray. Please expand your disclosure to identify
the adverse events
experienced by patients undergoing each treatment and the frequency of
each adverse
event. Provide comparative data for DHE mesylate IM injection and
Migranal DHE
mesylate liquid nasal spray and also discuss potential reason(s) for
the disparate results.
Also revise your disclosure on pages 2 or 3 to balance your Summary
disclosures on page
2 concerning STS101's safety and tolerability profile.
Comparison of STS101 PK Data to Other DHE Products, page 93
14. We note that in this section captioned, "Comparison of STS101 PK Data
to Other DHE
Products," you compare STS101 to Migranal DHE mesylate liquid nasal
spray and
MAP0004, but not to injectable DHE. Accordingly, please revise this
caption to clarify
that you are comparing STS101 to other DHE nasal sprays.
15. Please revise your disclosure to clarify, if true, that MAP0004 was
never approved by the
FDA and, therefore, FDA did not make a determination concerning the
efficacy or safety
of the drug candidate. Please also expand your disclosure to discuss
any known
differences in trial protocols, conditions and patient populations
that could materially
impact the comparability of the trial data sets presented.
Phase 3 Efficacy Trial, page 96
16. Please revise to identify the "certain" patient subgroups that you
reference in
the penultimate sentence on page 96.
Intellectual Property, page 100
17. We refer to your disclosure on page 33 concerning your "solely owned
patent
portfolio" and your disclosure on page 111 concerning your SNBL
license covering
John Kollins
Satsuma Pharmaceuticals, Inc.
July 19, 2019
Page 5
certain patent rights. Please revise your disclosure on page 100, and
elsewhere as
applicable, to clarify/distinguish the intellectual property rights
that you own and those
rights covered by the SNBL license. From your revised disclosures,
investors should be
able to determine the duration of your royalty obligations and the
term of the SNBL
license agreement, as it currently stands, for all jurisdictions where
you plan to
commercialize. Given the close connection between your Intellectual
Property discussion
and your SNBL license discussion, also consider revising the
presentation so that these
discussions appear in succession.
Government Regulation, page 101
18. We note your disclosure indicating that FDA will require you to
conduct human factors
studies to support approval of STS101. Please expand your disclosure
to explain what
these studies entail and revise your development plan disclosures on
pages 96-98 to
discuss your plans as they relate to these studies.
Coverage and Reimbursement, page 109
19. Given your disclosed plans to submit an NDA before the end of 2021,
please expand your
disclosure concerning coverage and reimbursement to discuss the
coverage and
reimbursement applicable to existing acute migraine treatments,
including those using
DHE.
Licenses and Collaborations, page 111
20. Please revise to disclose the amounts reimbursed to SNBL pursuant to
the license, or
advise.
General
21. Please provide us proofs of all graphics, visual, or photographic
information you will
provide in the printed prospectus prior to its use, for example in a
preliminary prospectus.
Please note that we may have comments regarding this material.
You may contact Mark Brunhofer at (202) 551-3638 or Jim Rosenberg,
Senior
Assistant Chief Accountant, at (202) 551-3679 if you have questions regarding
comments on the
financial statements and related matters. Please contact Irene Paik at (202)
551-6553 or Joseph
McCann at (202) 551-6262 with any other questions.
FirstName LastNameJohn Kollins Sincerely,
Comapany NameSatsuma Pharmaceuticals, Inc.
Division of
Corporation Finance
July 19, 2019 Page 5 Office of
Healthcare & Insurance
FirstName LastName