United States securities and exchange commission logo
February 29, 2024
Mark Lappe
Chief Executive Officer
Inhibrx Biosciences, Inc.
11025 N. Torrey Pines Road, Suite 140
La Jolla, CA 92037
Re: Inhibrx
Biosciences, Inc.
Draft Registration
Statement on Form 10
Submitted on
January 29, 2024
CIK No. 0002007919
Dear Mark Lappe:
We have reviewed your
draft registration statement and have the following comments.
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 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 the information you provide in response to this
letter and your amended
draft registration statement or filed registration statement, we may
have additional comments.
Draft Registration Statement on Form 10
What conditions must be satisfied to complete the Spin-Off?, page xi
1. Please clarify which
conditions are waivable. For example, it appears that you would be
unable to waive the
condition that there is no legal restraint against the Separation,
Distribution, or the
Merger. If you believe you are able to waive this condition, please
explain how you proceed
if there are legal restraints.
Information Statement Summary
Overview, page 1
2. We note your disclosure
that INBRX-109 is in a potentially registration-enabling trial in
Chondrosarcoma. Please
define the term "registration-enabling" and explain why this
study is "potentially"
registrational-enabling. Your discussion should clarify the factors
that will determine
whether it is registrational and who will make such determination. In
addition, please
provide balancing disclosure, as you do on page 14, that there can be no
Mark Lappe
FirstName LastNameMark
Inhibrx Biosciences, Inc. Lappe
Comapany29,
February NameInhibrx
2024 Biosciences, Inc.
February
Page 2 29, 2024 Page 2
FirstName LastName
assurance that any of your clinical trials will ultimately be
successful or support further
clinical development, including development in registration-enabling
trials of any of your
therapeutic candidates.
3. Please revise your information statement summary to briefly explain
scientific or technical
terms the first time they are used. By way of example only, we note
the following terms:
valent
Agonist Function
4. Please revise your graphics here, and elsewhere in the prospectus, to
ensure that all text is
legible.
5. Please revise your pipeline table to more specifically describe the
therapeutic indication(s)
you are developing your candidates to treat.
Our Strategy, page 2
6. With respect to your strategy to rapidly advance and optimize the
clinical development"
of your lead programs." Please delete the the statement that you
believe your programs
have the potential to reach the marketplace as soon as 2026 with your
first commercial
therapeutic. Such a prediction is speculative and requires you to
predict the outcome of
your ongoing clincial trials, as well as the regulatory decisions and
timing with respect to
additional clincial trials and approval. Additionally, provide
balancing disclosure
indicating that that results of preclinical studies and early stage
clinical trials of your
therapeutic candidates may not be predictive of the results of later
stage clinical trials,
your initial intent to seek approval as a second or third-line
therapy, your novel and
unproven approach to protein engineering, and unforeseen
circumstances, such as the
partial clincial hold experienced in 2023, can lead to delays and
additional expense.
Risk Factors
Risks Related to the Development, Clinical Testing and Commercialization of Our
Therapeutic
Candidates, page 13
7. Please include a separate, standalone risk factor disclosing that your
approach to protein
engineering is "novel and unproven, and as such, the cost, time needed
to develop, and
likelihood of success may be more uncertain" than if you employed more
established drug
development approaches.
Our therapeutic candidates may cause undesirable side effects that could delay
or prevent their
marketing approval..., page 14
8. We note your disclosure on page 15 that certain trial participants
have in the past
experienced serious adverse events that could be related to one of
your therapeutic
candidates. Please revise to describe all serious adverse events that
occurred in your
clinical trials and quantify the number of occurrences. With respect
to the disclosures
Mark Lappe
FirstName LastNameMark
Inhibrx Biosciences, Inc. Lappe
Comapany29,
February NameInhibrx
2024 Biosciences, Inc.
February
Page 3 29, 2024 Page 3
FirstName LastName
regarding the partial clinical hold and grade 5 hepatotoxicity event
on pages 14 and 86,
please define grade 5 and confirm, if true, that this is a
serious adverse event.
We are currently party to license agreements with Elpiscience and Transcenta
for the
development..., page 18
9. Please disclose, as you do on page 93, that the Transcenta Agreement
includes
development and, if approved, commercialization in China, Hong Kong,
Macau and
Taiwan for INBRX-109.
Business
Our Pipeline, page 81
10. Please revise your disclosure on page 86 to clarify that the grade 5
hepatotoxicity event
was a seriouse adverse event. Additionally, with response to your
disclosure that the
adverse events related to Part 1 of your INBRX-106 trial being "mostly
mild or moderate"
and patients in the the Parts 3 and 4 of this trial having
"predominently mild or moderate
immune-related toxicities." Please clarify whether any of these
adverse events were
considered to be serious adverse events.
The 2020 2seventy Agreement, page 94
11. With respect to the 2020 2seventy Agreement, please revise to clarify
when the patent
underlying the royalty term is expected to expire.
Unaudited Pro Forma Condensed Consolidated Financial Statements, page 129
12. Please provide us an accounting analysis supporting your conclusion
that carve out
financial statements are not required for Inhibrx Biosciences Inc.
that includes your
valuation of the INBRX-101 Business, also referred to as RemainCo
Business, compared
to the SpinCo Business and consideration of the $2.2 billion
transaction value for the sale
of INBRX-101 to Sanofi as announced on January 23, 2024. In this
regard, explain
how the Chiesi Option Agreement is expected to impact your sale of the
1INBRX-01
Business to Sanofi. Refer us to the technical guidance upon which you
relied. Also,
provide the Exhibits and Schedules that appear to have been omitted
from the Separation
and Distribution Agreement in Form 8-K filed by Inhibrx Inc. on
January 23, 2024.
Management's Discussion and Analysis of Financial Condition and Results of
Operations, page
134
13. You disclose on page 139 that you do not track your internal research
and development
expenses on a program-by-program basis as they primarily relate to
personnel, early
research and consumable costs, which are deployed across multiple
projects under
development. To the extent you track your external research and
development expenses
Mark Lappe
Inhibrx Biosciences, Inc.
February 29, 2024
Page 4
on a program-by-program basis, revise to quantify the expenses on that
basis. If you do
not track your external costs, disclose that fact.
Notes to Consolidated Financial Statements
6. License and Grant Revenues, page F-21
14. Please revise Note 6 or elsewhere in your footnotes as applicable to
provide disclosure
regarding your collaboration with Transcenta including to provide
quantification ofthe
terms governing the license agreement, the key assumptions and methods
used to report
activity under the agreements, and the associated impact on your
financial statements.
Refer us to the technical guidance upon which you relied.
Please contact Franklin Wyman at 202-551-3660 or Kevin Vaughn at
202-551-3494 if
you have questions regarding comments on the financial statements and related
matters. Please
contact Jimmy (CF) McNamara at 202-551-7349 or Suzanne Hayes at 202-551-3675
with any
other questions.
FirstName LastNameMark Lappe Sincerely,
Comapany NameInhibrx Biosciences, Inc.
Division of
Corporation Finance
February 29, 2024 Page 4 Office of Life
Sciences
FirstName LastName