United States securities and exchange commission logo
May 29, 2020
David Hilbert
President and Chief Executive Officer
Arcellx, Inc.
25 West Watkins Mill Road, Suite A
Gaithersburg, MD 20878
Re: Arcellx, Inc.
Draft Registration
Statement on Form S-1
Submitted May 1,
2020
CIK No. 0001786205
Dear Dr. Hilbert:
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.
DRS Submitted May 1, 2020
Prospectus Summary
Overview, page 1
1. Given the status of
development, please revise your statements on page 1 concerning what
a treating physician
can do using your sparX proteins. Also, revise to clarify why you
believe that your
binding domains have the potential to enable accelerated clinical
development across
multiple disease franchises.
2. Revise the summary to
define "BCMA" when the term is first used, and explain it.
David Hilbert
FirstName LastNameDavid Hilbert
Arcellx, Inc.
Comapany NameArcellx, Inc.
May 29, 2020
Page 2
May 29, 2020 Page 2
FirstName LastName
Our Platform, page 2
3. To provide context and balance to your Summary presentation concerning
your platform,
please revise your disclosure on pages 2-3 to explain briefly your
basis for asserting each
of the six "key benefits" that you cite. In this regard, we refer to
your disclosure in the
first full factor on page 15 which discusses the "intended benefits"
of your platform. To
the extent that your claims are based on pre-clinical testing, please
indicate whether such
testing has yielded statistically significant results.
4. Please tell us your basis for highlighting "efficient and streamlined
manufacturing across
all programs" given your risk factor disclosure on page 15 indicates
that you have not
exhaustively explored different options in the method for
manufacturing ARC-T cells and
sparX proteins.
Our Pipeline, page 4
5. Please tell us whether your current plan is to advance CART-ddBCMA for
the treatment
of multiple myeloma through Phase 2 and Phase 3 of development and
then to
commercialize it. In this regard, we note that your disclosure at the
bottom of page 5
indicates that you intend to achieve your goals by developing product
candidates from
your ARC-sparX platform, as an alternative to CAR-T therapies. We
further note that
your Use of Proceeds discussion indicates that you plan to use all of
the offering proceeds
to advance ARC-sparX platform candidates rather than your CART-ddBCMA
candidate. In addition, please revise your Summary and pipeline table
presentations to
reflect the relative significance of each product candidate
irrespective of whether it is
clinical-stage or pre-clinical. In this regard, we note that your
disclosure on page 6 states
that you are dependent on the success of your ACLX-001 drug candidate.
6. Please tell us your basis for including ACLX-001 for the treatment of
Autoimmune
Diseases in your Clinical and Preclincial Pipeline table. In this
regard, we note that it is
unclear which autoimmune disease or diseases you are targeting nor do
we see disclosure
in the prospectus concerning pre-clinical testing that you have
conducted in this area.
7. Please tell us why you believe that the Discovery Pipeline table
should appear
prominently in the Summary given the limited disclosures provided on
page 111
concerning your plans, particularly as they relate to AML/MDS and
Autoimmune
Diseases.
Our Strategy, page 5
8. Please revise here and elsewhere in the Summary to explain how your
clinical
development strategy is innovative.
Our Team, page 5
9. You indicate here and on page 87 that Takeda Ventures is part of the
strong group of
David Hilbert
Arcellx, Inc.
May 29, 2020
Page 3
investors that share your commitment to advancing your next generation
cell therapy
platform. On pages 21 and 113, you also cite Takeda as one of your
competitors, as it is
also "developing genetically-engineered natural killer (NK) cell
therapies." Please tell us,
and revise, as applicable, to indicate whether you face risks in
potentially competing with
this shareholder.
Implications of Being an Emerging Growth Company, page 7
10. Please 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.
Use of Proceeds, page 65
11. Please revise to disclose the amount of proceeds that you intend to
allocate toward the
development of each drug product candidate, or as applicable, toward
each franchise. For
each candidate and/or franchise, disclose the trial phase or phases
that you intend to fund
with the proceeds and indicate whether your plans call for additional
funding to complete
that phase or phases. Refer to Item 504 of Regulation S-K.
12. On page 65 you state that your use of proceeds depends on numerous
factors, including
"the amount of cash obtained through our existing collaborations and
future
collaborations, if any." In note 2 of your financial statements and
elsewhere, you state
you have no current collaborations. Accordingly, please revise to
clarify whether you are
currently involved in any material collaborations, and if so, describe
them and provide
the collaboration agreements as exhibits as required by Item
601(b)(10) of Regulation S-
K.
Management's discussion and analysis of financial condition and results of
operations
Critical accounting policies and estimates
Determination of the fair value of our common stock, page 81
13. Please also discuss the methods that management used to determine the
enterprise value of
the company underlying the fair value determination of the company's
shares and the
nature of the material assumptions involved.
14. Once you have an estimated offering price or range, please explain to us
how you
determined the fair value of the common stock underlying your equity
issuances and the
reasons for any differences between the recent valuations of your common
stock leading
FirstName LastNameDavid Hilbert
up to the initial public offering and the estimated offering price. This
information will help
Comapany NameArcellx, Inc. your accounting for equity issuances including stock
compensation
facilitate our review of
May 29, 2020 Page 3 conversion features.
and beneficial
FirstName LastName
David Hilbert
FirstName LastNameDavid Hilbert
Arcellx, Inc.
Comapany NameArcellx, Inc.
May 29, 2020
Page 4
May 29, 2020 Page 4
FirstName LastName
Our Product Candidates, page 103
15. Please revise your disclosures on page 103-111 concerning each
pre-clinical study to state
the "n" and "p" values and to clarify whether the results are
statistically significant. Also,
clarify whether human cells were used in the in vitro tests.
CART-ddBCMA: Phase 1 Trial, page 104
16. Please revise to discuss when the trial commenced, its size, and
whether it is fully
enrolled. With reference to your disclosures on pages 1 and 103,
please indicate how you
will assess efficacy and indicate whether you plan to have ORR and
median duration of
response data to report in 2020.
Our Products
Cart-ddBCMA: In Vivo Preclinical Results, page 105
17. In explaining the chart on the bottom of page 106, you state,
"Fourteen days following
treatment with CART-ddBCMA, all mice in the highest dose group showed
complete
eradication of the diseased cells with no evidence of bioluminescense
in any of the mice."
In the accompanying chart, however, it appears that one of the five
subjects is missing
from the Day 14 post CART and Day 21 post CART graphics. Please revise
or advise.
You may contact Tracey Houser at (202) 551-3736 or Kate Tillan at (202)
551-3604 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,
Division of
Corporation Finance
Office of Life
Sciences
cc: Dan Koeppen