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United States securities and exchange commission logo
January 11, 2021
Kevin R. Lind
President, Chief Executive Officer and Chief Financial Officer
Longboard Pharmaceuticals, Inc.
6154 Nancy Ridge Drive
San Diego, CA 92121
Re: Longboard
Pharmaceuticals, Inc.
Draft Registration
Statement on Form S-1
Submitted December
15, 2020
CIK No. 0001832168
Dear Mr. Lind:
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 December 15, 2020
Prospectus Summary, page 1
1. We note your statements
on page 1 and elsewhere that your product candidates are highly
selective. Please
remove all statements that present your conclusions regarding the
efficacy of your
product candidate as this is a determination within the authority of the
U.S. Food and Drug
Administration and comparable regulatory bodies or advise why this
disclosure is
appropriate.
2. We note that 5-HT2a
and 5-HT2b receptor subtypes have been known to be associated
with significant
adverse side effects. Please revise to briefly describe the type and
severity of the adverse
side effects associated with 5-HT2a and 5-HT2b receptor
subtypes.
Kevin R. Lind
Longboard Pharmaceuticals, Inc.
January 11, 2021
Page 2
3. Please revise to clarify the relationship, if any, between the
expanded access program
referenced on page 2 and the Phase 3 clinical trial referenced on page
4. Please also revise
to briefly explain what an expanded access program is.
4. On page 3 you state that Arena designed LP352, LP143, and LP659 to
have distinct
chemistry and therapeutic profiles from Arena s other product
candidates with similar
mechanisms of actions. Please revise to briefly explain how your
product candidates are
distinct from Arena s.
MANAGEMENT'S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND
RESULTS OF OPERATIONS
Royalty Purchase Agreement, page 78
5. Please revise to disclose the material terms of your Royalty Purchase
Agreement,
including, without limitation, the upfront purchase fee paid, the
aggregate milestones
payable, the royalties payable, the term of the agreement, and
termination provisions.
Business
Our Product Candidates
LP352, an oral, centrally acting, highly selective 5-HT2c superagonist, page 93
6. On page 97 you state that Lorcaserin has been tested in a small
study of off-label use in
five children with Dravet syndrome, for which all patients in the
study exhibited some
degree of decreased seizure activity. Please revise to more
specifically describe the
results of the study.
7. We note your acknowledgement that the studies included in the
comparison table on page
97 were not head-to-head studies. Please tell us why you believe these
comparisons are
appropriate. Address in your response whether you expect to be able to
rely on such
comparisons to support an application for marketing approval.
8. We note your statement on page 97 that LP352 has potential
"best-in-class" selectivity.
This term suggests that your product candidates are effective and likely
to be approved.
Please delete this reference. If your use of the term was designed to
convey your belief
that your product candidates are based on a differentiated technology or
approach, you
may further discuss how your technology or approach differs from those
of your
competitors.
FirstName LastNameKevin R. Lind
9. Please revise page 99 to state the number of subjects reflected in the
results of Parts A and
Comapany
B ofNameLongboard Pharmaceuticals,
your Phase 1 clinical Inc. please revise to explain
what you mean by
trial. Additionally,
January no
11,significant
2021 Pagefood
2 effect and explain the target plasma exposure
obtained.
FirstName LastName
Kevin R. Lind
FirstName
Longboard LastNameKevin
Pharmaceuticals,R. Lind
Inc.
Comapany
January 11,NameLongboard
2021 Pharmaceuticals, Inc.
January
Page 3 11, 2021 Page 3
FirstName LastName
LP143, a centrally acting, highly selective, full CB2 agonist, page 99
10. Please revise page 102 to describe the LP143 and LP659 pre-clinical
studies in further
detail, including the number of subjects and duration, and, if powered
for statistical
significance, p-values.
LP659, a centrally acting, highly selective S1P1,5 modulator, page 102
11. Please revise page 103 to explain the basis for the statement that the
S1P1 receptor has
been well validated.
License Agreement with Arena, page 104
12. Please revise page 104 to describe the certain products
commercialized by Arena and
any upfront payments paid or payable under the agreement.
Additionally, on page 105 you
mention that the Arena License Agreement requires payment of
milestones and/or
royalties. To the extent applicable, please revise your description
of the agreement on
page 104 to include a description of any milestone payment provisions.
We also note that
on page 104 you say the term will expire on the latest to occur of
several events, including
the expiration date of the last valid claim on a country-by-country
basis. Please revise to
clarify when these claims are expected to expire.
Intellectual Property, page 105
13. Please revise to clarify which jurisdictions have granted patents for
compositions of
matter and methods of treatment and their respective expiration dates.
Additionally,
please revise to disclose the expected expiration dates for pending
patent applications and
the identification of all applicable jurisdictions where patents
applications are pending.
Certain Relationships and Related Person Transactions, page 142
14. Please revise page 142 to state the fees payable under the Services
Agreement with Arena
pursuant to Item 404(a)(3) of Regulation S-K.
General
15. 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.
Kevin R. Lind
FirstName
Longboard LastNameKevin
Pharmaceuticals,R. Lind
Inc.
Comapany
January 11,NameLongboard
2021 Pharmaceuticals, Inc.
January
Page 4 11, 2021 Page 4
FirstName LastName
You may contact Jeanne Bennett at 202-551-3606 or Mary Mast at
202-551-3613 if you
have questions regarding comments on the financial statements and related
matters. Please
contact Margaret Schwartz at 202-551-7153 or Jeffrey Gabor at 202-551-2544 with
any other
questions.
Sincerely,
Division of Corporation
Finance
Office of Life Sciences
cc: Steve Przesmicki, Esq.