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United States securities and exchange commission logo
July 28, 2022
Vlad Couric, M.D.
Chief Executive Officer
Biohaven Research Ltd.
215 Church Street
New Haven, CT 06510
Re: Biohaven Research
Ltd.
Draft Registration
Statement on Form 10
Submitted July 1,
2022
CIK No. 0001935979
Dear Dr. Couric:
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 10 submitted July 1, 2022
Exhibit 99.1
Questions and Answers About the Distribution Agreement
Q: What conditions must be satisfied to complete the Spin-Off?, page 3
1. Please revise this Q&A
to discuss any material consequences to shareholders if any of the
listed conditions are
waived and Biohaven Pharmaceutical Holding proceeds with the
spin-off. In addition,
please revise to identify the conditions that are subject to waiver.
Vlad Couric, M.D.
FirstName LastNameVlad
Biohaven Research Ltd. Couric, M.D.
Comapany
July NameBiohaven Research Ltd.
28, 2022
July 28,
Page 2 2022 Page 2
FirstName LastName
Information Statement Summary
Product Candidates, page 7
2. We note the inclusion of the product candidate "UC1MT" for the
indications of
inflammatory and autoimmune diseases and certain other preclinical
product candidates in
your pipeline table labeled "BHV-TBD." In addition, we note your
disclosure on page 112
that you "currently operate in a single business segment developing a
portfolio of
innovative, late-stage product candidates targeting neurological
diseases." Given the
limited disclosure related to UC1MT, please explain why it is
sufficiently material to your
business to warrant inclusion in your pipeline table. If it is
material, please expand your
disclosure in the Business section to provide a more fulsome
discussion of this candidate,
including a description of preclinical studies, development activities
conducted, or
ongoing clinical trials. Alternatively, remove UC1MT and any other
preclinical product
candidates that are not currently material to your business from your
pipeline table on
pages 7 and 75.
The Separation and Distribution
The Distribution Agreement, page 57
3. We note disclosure here stating Biohaven Research Ltd will be assigned
liabilities
resulting from "certain specified legal proceedings." We further note
disclosure in your
Legal Proceedings section stating you are currently not party to any
material legal
proceedings. Please reconcile your disclosure or advise.
Business
Product Candidates, page 75
4. Please remove the references throughout your information statement to
"first-in-class" or
"best-in-class" product candidates as these descriptions imply an
expectation of regulatory
approval and are inappropriate given the length of time and
uncertainty with respect to
securing marketing approval.
5. Please revise any statements concluding your product candidates are
safe or effective to
instead refer to objective trial results. For example only, we note
disclosure on page 75
where you state that your Kv7 platform is a "potent" activator, on
page 82 where you state
that troriluzole demonstrated "acceptable safety" consistent with past
clinical trial
experiences and on page 87 where you state "BHV-2100 shows promising
efficacy."
Please remove these statements, and any similar statements, as
conclusions of safety and
efficacy are within the sole authority of the FDA and comparable
foreign regulators.
6. At first use, please define abbreviations. For example only, we note
that "SCA," "ALS"
and "SMA" are not defined at first use.
7. In your discussion of the preclinical and clinical development of your
material programs,
please revise your disclosure to specify the following information
with respect to the trials
Vlad Couric, M.D.
FirstName LastNameVlad
Biohaven Research Ltd. Couric, M.D.
Comapany
July NameBiohaven Research Ltd.
28, 2022
July 28,
Page 3 2022 Page 3
FirstName LastName
that you have conducted, are currently conducting or plan to conduct:
the trial design;
the number of participants in the trial;
the primary and secondary endpoints as well as the results as they
relate to those
endpoints; and
the occurrence of any serious adverse events.
As example only, we refer to your disclosure on page 125 that
"Troriluzole was well
tolerated with a safety profile consistent with past clinical trial
experience." Please revise
to expand your disclosure to discuss the observance of any serious
adverse events for each
of you material product candidates under development or otherwise
advise. In addition,
we note your disclosure here that, [t]wo Phase 3 studies are currently
ongoing with
enrollment expected to be completed in the second half of 2022."
Please revise to discuss
the trial design and primary and secondary endpoints of the ongoing
studies or otherwise
advise.
TDP-43 Mechanisms of Action, page 88
8. Please revise to provide narrative disclosure explaining the graphic
depicted in this
section.
Intellectual Property
Patents and Patent Applications, page 95
9. Please revise your discussion of each material patent or patent
application to disclose the
jurisdictions where each patent or patent application is protected.
Licensing Agreements, page 97
10. Please revise your discussion of your Licensing Agreements to disclose
the aggregate
potential milestone payments and quantify the amount paid to date
under such agreements.
Please also file these material agreements as exhibits to your
registration statement or
provide your analysis as to why you do not believe filing is required.
Refer to Item 601 of
Regulation S-K for guidance.
Financial Statements
10. Subsequent Events
Kv7 Platform Acquisition, page F-26
11. You state that in April 2022 you acquired Channel Biosciences, LLC
which you expect to
account for as an asset acquisition since substantially all of the
fair value of the gross
assets acquired was concentrated in a single identifiable asset.
Please address the
following:
Tell us why you believe that substantially all of the gross assets
acquired was
concentrated in a single identifiable asset.
Tell us your consideration of including financial statements and
pro forma
Vlad Couric, M.D.
Biohaven Research Ltd.
July 28, 2022
Page 4
information in accordance with Rule 3-05 and Article 11 of
Regulation S-X. In this
regard, if you continue to believe the criteria in ASC 805-10-55-5A
has been met,
please address if the acquisition met the definition of a business
in Rule 11-01(d) of
Regulation S-X.
Exhibits
12. We note your disclosure on page 124 where you discuss your acquisition
from Knopp
Biosciences LLC of Channel Biosciences, LLC. Please file the acquisition
agreement as
an exhibit to the registration statement or tell us why you are not
required to do so. Refer
to Item 601(b)(10) of Regulation S-K.
13. We note your disclosure beginning on page 145 discussing your employment
agreements
and offer letters with your executive officers. Please file the
agreements and include such
agreements in the exhibit index or tell us why you are not required to do
so. See Item
601(b)(10)(iii) of Regulation S-K.
You may contact Julie Sherman at 202-551-3640 or Mary Mast at
202-551-3613 if you
have questions regarding comments on the financial statements and related
matters. Please
contact Tyler Howes at 202-551-3370 or Jason Drory at 202-551-8342 with any
other questions.
Sincerely,
FirstName LastNameVlad Couric, M.D.
Division of
Corporation Finance
Comapany NameBiohaven Research Ltd.
Office of Life
Sciences
July 28, 2022 Page 4
cc: Robert Downes, Esq.
FirstName LastName