0000000000-19-008783.txt : 20190726
0000000000-19-008783.hdr.sgml : 20190726
20190521164418
ACCESSION NUMBER: 0000000000-19-008783
CONFORMED SUBMISSION TYPE: UPLOAD
PUBLIC DOCUMENT COUNT: 2
FILED AS OF DATE: 20190521
FILED FOR:
COMPANY DATA:
COMPANY CONFORMED NAME: Karuna Therapeutics, Inc.
CENTRAL INDEX KEY: 0001771917
STANDARD INDUSTRIAL CLASSIFICATION: PHARMACEUTICAL PREPARATIONS [2834]
IRS NUMBER: 270605902
FISCAL YEAR END: 1231
FILING VALUES:
FORM TYPE: UPLOAD
BUSINESS ADDRESS:
STREET 1: 33 ARCH STREET
STREET 2: SUITE 3110
CITY: BOSTON
STATE: MA
ZIP: 02110
BUSINESS PHONE: 857-449-2244
MAIL ADDRESS:
STREET 1: 33 ARCH STREET
STREET 2: SUITE 3110
CITY: BOSTON
STATE: MA
ZIP: 02110
LETTER
1
filename1.pdf
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TEXT-EXTRACT
2
filename2.txt
May 21, 2019
Steven Paul, M.D.
Chief Executive Officer, President and Chairman
Karuna Therapeutics, Inc.
33 Arch Street, Suite 3110
Boston, MA 02110
Re: Karuna Therapeutics, Inc.
Amendment No. 1 to Draft Registration Statement on Form S-1
Submitted May 2, 2019
CIK No. 0001771917
Dear Dr. Paul:
We have reviewed your amended 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.
Amendment No. 1 to Draft Registration Statement on Form S-1
Pipeline Overview, page 2
1. We note your response to prior comment 1 and your revised disclosure on
page 115 that
you have commenced preclinical development of therapeutic agents in
schizophrenia,
psychosis associated with AD, and various forms of pain. Please further
expand your
disclosure on page 115 to provide a summary of the studies performed.
Third-Party Clinical Trials Support Xanomelines Development, page 3
2. We note your response to prior comment 2 and your revised disclosure on
page 109
indicating your belief that xanomeline has shown antipsychotic and
procognitive benefits.
Please revise to remove the suggestion that your product candidate is
responsible for these
Steven Paul, M.D.
Karuna Therapeutics, Inc.
May 21, 2019
Page 2
benefits. To the extent your conclusion is based on the results of your
clinical trials, you
may present the data from the clinical trials.
Exclusive Jurisdiction for Certain Actions, page 171
3. We note the revisions in response to comment 8. Please revise your
disclosure to
specifically state that the exclusive forum provisions do not apply to
actions arising under
the federal securities laws.
You may contact Bonnie Baynes at 202-551-4924 or Angela Connell at
202-551-3426 if
you have questions regarding comments on the financial statements and related
matters. Please
contact Jeffrey Gabor at 202-551-2544 or Suzanne Hayes at 202-551-3675 with any
other
questions.
Sincerely,
FirstName LastNameSteven Paul, M.D.
Division of
Corporation Finance
Comapany NameKaruna Therapeutics, Inc.
Office of
Healthcare & Insurance
May 21, 2019 Page 2
cc: Seo Salimi, Esq.
FirstName LastName
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