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United States securities and exchange commission logo
October 10, 2023
Donna Cochener, Esq.
Interim Chief Executive Officer, General Counsel
Neoleukin Therapeutics, Inc.
188 East Blaine Street, Suite 450
Seattle, Washington 98102
Re: Neoleukin
Therapeutics, Inc.
Amendment No. 1 to
Registration Statement on Form S-4
Filed September 28,
2023
File No. 333-274095
Dear Donna Cochener:
We have reviewed your amended registration statement and have the
following
comments.
Please respond to this letter by amending your registration
statement and providing the
requested information. If you do not believe a comment applies 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 this letter, we may have additional comments.
Unless we note otherwise,
any references to prior comments are to comments in our September 18,
2023 letter.
Amendment No. 1 to Registration Statement on Form S-4
Prospectus Summary, page 12
1. We note your response
to prior comment 19. Please include disclosure here and in the
"Neurogene's Business"
section of the substantive portion of your response that after the
phase 1/2 trials,
Neurogene may pursue, and the FDA may allow, adaption to integrate a
pivotal trial design
within a single study as opposed to a separate classic phase 3 trial but
caution, however, that
regulatory authorities may recommend changes to the study designs
for NGN-401 or NGN-101,
including the number and size of registrational clinical trials
required to be
conducted in such programs.
The Merger
Background of the Merger, page 107
2. We note your response
to our prior comment 9. As requested by our prior comment,
Donna Cochener, Esq.
Neoleukin Therapeutics, Inc.
October 10, 2023
Page 2
please also include a short description of the criteria used to identify
the initial 59
pharmaceutical companies.
Unaudited Pro Forma Condensed Combined Financial Information
Notes to the Unaudited Pro Forma Condensed Combined Financial Information
5. Transaction Accounting Adjustments, page 338
3. In your response you noted that the fair value of Neoleukin s shares,
as a publicly traded
company, is more reliably determinable than the fair value of the assets
acquired from
Neoleukin and that the fair value of net assets acquired would involve a
third party
valuation using Level 3 fair value inputs. As the assets acquired
primarily consists of cash
and short-term investments, which use level 1 fair value inputs, it
remains unclear to us
how you determined that the fair value of the consideration given was
more clearly
evident and reliably measurable than the fair value of the net assets
acquired. In this
regard, we note your disclosure on page 333 that "on a pro forma basis,
assuming the
merger was consummated on June 30, 2023, the fair value of the net assets
acquired,
including aggregate cash and cash equivalents, short-term investments,
and other
immaterial monetary assets, totaling approximately $83.4 million." In
contrast, the fair
value of the consideration transferred was $46.7 million (prior to
consideration of
contingent CVRs). Please advise and explain to what you attribute the
perceived discount
on this reverse asset purchase.
4. As a related matter, you noted in your response that you used
interpretative guidance
under Subtopic 323-10 which may require the recognition of the contingent
consideration
if it relates to the acquisition of an investment that is accounted for
under the equity
method. As the CVR does not appear to give the investors the ability to
exercise
significant influence over operating and financial policies of an
investee (Neoluekin), it is
not clear to us why this interpretive guidance was used. In this regard,
as noted in your
response, accounting for the CVR under Topic 450 was one of the examples
provided in
EIFT Issue 09-2. Please tell us your consideration of this guidance in
your accounting
analysis.
Please contact Sasha Parikh at 202-551-3627 or Angela Connell at
202-551-3426 if you
have questions regarding comments on the financial statements and related
matters. Please
contact Doris Stacey Gama at 202-551-3188 or Tim Buchmiller at 202-551-3635
with any other
questions.
Sincerely,
FirstName LastNameDonna Cochener, Esq.
Division of
Corporation Finance
Comapany NameNeoleukin Therapeutics, Inc.
Office of Life
Sciences
October 10, 2023 Page 2
cc: Robert A. Freedman, Esq.
FirstName LastName