United States securities and exchange commission logo
December 22, 2021
David Hilbert
President and Chief Executive Officer
Arcellx, Inc.
25 West Watkins Mill Road, Suite A
Gaithersburg, MD 20878
Re: Arcellx, Inc.
Amendment No. 2 to
Draft Registration Statement on Form S-1
Submitted November
19, 2021
CIK No. 0001786205
Dear Dr. Hilbert:
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. 2 to Draft Registration Statement on Form S-1 Submitted
November 19, 2021
Prospectus Summary
Overview, page 1
1. Please revise the
Overview to provide a balanced presentation of the status and
capabilities of the
platforms you are developing and the preliminary Phase 1 data that you
prominently highlight
concerning your CART-ddBCMA candidate. For instance, we note
several statements in
the Overview regarding validation of meaningful clinical benefits",
"higher transduction
efficiency , improved lasting therapeutic benefit and reduced
toxicity" and
"potential for best-in class treatment." With reference to your disclosure on
page 14, we note that
it should be clear in the Overview that you are still developing each
of these three
platforms, and that you have treated a small number of patients using a
David Hilbert
FirstName LastNameDavid Hilbert
Arcellx, Inc.
Comapany22,
December NameArcellx,
2021 Inc.
December
Page 2 22, 2021 Page 2
FirstName LastName
product developed under the D-Domain and ddCAR platforms and that
those results are
preliminary in nature. With respect to ARC-SparX platform, please
revise the disclosure
to explain, if applicable, that your statements of belief are based on
preclinical testing that
you have conducted.
2. Please revise the second and third paragraphs of the Overview to
define or explain briefly
the following scientific terms:
refractory
cytogenetics
extramedullary
bone marrow blasts
Also, revise to explain the terms overall response rate and
complete response rate and
clarify, if true, that these response rates do not indicate that the
patient was cured of the
condition.
3. We refer to prior comment 1 and your June 9, 2021 response to prior
comment 5. Without
revision to the table, it appears that you intend to both develop and
commercialize your
CART-ddBCMA technology. Please advise and revise the Summary
discussion to clarify
your development plans for this product, including any changes with
respect to
clinical advancement and commercialization.
4. Please revise the pipeline table as follows:
Replace the term "Pivotal" with "Phase III." If "Pivotal" is
intended to mean
something other than Phase III, please provide disclosure to
clarify. Make similar
revisions throughout your prospectus for consistency.
Provide an additional column for Phase III that is no less
prominent than the other
columns, or tell us the basis for your belief that you will be
able to combine Phase II
and Phase III for all of your product candidates.
Given the status of development and the lack of Business section
discussion, remove
the AML-2, AML-3, AML-4 and the solid tumor programs from the
pipeline table.
Management's Discussion and Analysis of Financial Condition and Results of
Operations
Contractual Obligations, page 86
5. Please expand your disclosure of the agreements CMOs and other third
party vendors to
disclose the amount of milestone payments that you are subject to pay
to the extent that
those milestones are met.
Critical Accounting Policies and Estimates
Determining the fair value of our common stock and fair value of total equity,
page 89
6. As previously requested in comment 13 in our letter dated May 29,
2020, please expand
your disclosure to provide the specific valuation approaches and
methods used to estimate
the fair value of your common stock and total equity that are
consistent with the American
Institute of Certified Public Accountants Audit and Accounting
Practice Aid Series:
Valuation of Privately Held Company Equity Securities Issued as
Compensation,
David Hilbert
Arcellx, Inc.
December 22, 2021
Page 3
including the nature of the material assumptions used in each method.
Business
CART-ddBCMA: Phase 1 Trial Preliminary Results, page 112
7. Revise the graphics on page 115 so the font is large enough to be
readable.
8. Revise the discussion of the discussion on page 115 to clarify if
cytokine release
syndrome (CRS) and immune effector cell-associated neurotoxicity
syndrome (ICANS)
were the only adverse events that occurred in connection with the
clinical trial, or revise to
disclose all adverse events.
Intellectual Property, page 125
9. Please revise your intellectual property disclosure to clearly describe
on an individual or
patent family basis the type of patent protection granted for each
product, the number of
patents held, the expiration year of each patent held, and the
jurisdiction of each patent. In
this regard it may be useful to provide tabular disclosure. Please
clearly indicate the
number of U.S. patents, the number of foreign patents, and name the
jurisdictions for the
foreign patents or applications.
12. Share-Based Compensation
Restricted Stock Units, page F-35
10. We note your disclosure that the fair value of the RSUs was determined
by an independent
valuation specialist. Please tell us the nature and extent of the
specialist s involvement
and whether you believe the specialist was acting as an expert as
defined under Section
11(a) of the Securities Act of 1933 and Section 436(b) of Regulation C,
such that you
must disclose the name of the specialist in the Form S-1 along with a
consent from the
specialist once the Form S-1 is publicly filed. If you conclude the
specialist is not
considered an expert under the Securities Act, please revise your
disclosures to clarify.
You may contact Tracey Houser at (202) 551-3736 or Al Pavot at (202)
551-3738 if you
have questions regarding comments on the financial statements and related
matters. Please
contact Abby Adams at (202) 551-6902 or Joe McCann at (202) 551-6262 with any
other
questions.
Sincerely,
FirstName LastNameDavid Hilbert
Division of
Corporation Finance
Comapany NameArcellx, Inc.
Office of Life
Sciences
December 22, 2021 Page 3
cc: Dan Koeppen
FirstName LastName