United States securities and exchange commission logo
July 20, 2023
Ken Song, M.D.
President and Chief Executive Officer
RayzeBio, Inc.
5505 Morehouse Drive, Suite 300
San Diego, CA 92121
Re: RayzeBio, Inc.
Amendment No. 2 to
Draft Registration Statement on Form S-1
Submitted June 23,
2023
CIK No. 0001825367
Dear Ken Song:
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
June 23, 2023
Cover Page
1. Please revise the
disclosure on the cover page to clarify whether the offering is contingent
upon final approval of
your Nasdaq listing. Please ensure that the disclosure is consistent
with your underwriting
agreement.
Prospectus Summary, page 1
2. We note your disclosure
on page 1 that "SSTR2 is a clinically validated target that is
expressed in multiple
solid tumors" and that "DOTATATE" is a "clinically-validated
peptide binder, and a
chelator[.]" Please clarify your disclosure here, and elsewhere as
appropriate, to explain
what is meant by "clinically validated" in both of these contexts.
Ken Song, M.D.
FirstName LastNameKen Song, M.D.
RayzeBio, Inc.
Comapany
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20, 2023
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3. We note your disclosure on page 1 that you have "established a
leadership position in the
emerging radiopharmaceutical therapeutics modality[.]" Please revise
your disclosure
here and elsewhere as appropriate to provide a basis for this claim.
To the extent this
statement reflects management's belief, please revise your disclosure
accordingly.
4. We note your disclosure on page 2 that "partial response" "has been
confirmed in five of
the 17 patients enrolled, representing an objective response rate, or
ORR, of 29%." Please
revise your disclosure here, and elsewhere as appropriate, to explain
what is meant by
"partial response" and "objective response rate."
Our programs, page 2
5. With regard to your pipeline table here, on page 119 and page 125,
please tell us what the
difference is between the "discovery" stage and the "IND enabling"
stage. To the extent
that both of these stages are meant to characterize pre-clinical work,
please revise your
pipeline table to remove the distinction between the discovery stage
and the IND enabling
stage and clarify which drug candidates are still in the pre-clinical
stage and which
candidates are now in clinical trials. Additionally, please revise the
arrows in your
pipeline tables in the hepatocellular carcinoma row to clarify that
you have not yet
obtained an IND for any other indications aside from GEP-NETs and
ES-SCLC. We also
note the row for SSTR2 - RYZ101 for "other cancers" and the row for
"next generation
binder - multiple cancers." No specific types of cancer are identified
and there does not
appear to be any detailed disclosure regarding these programs.
Additionally, CA9 for
"small molecule targeting" for renal cell cancer has no product
candidate named and it
does not appear to have begun development. The "other" row is
similarly
unsubstantiated. It appears these programs should be removed as they
are not material
enough to be included in your pipeline table. Please revise to provide
additional
disclosure that justifies the inclusion of these programs in your
pipeline table and
demonstrates their materiality or remove them from your table.
Our team and investors, page 4
6. We note your disclosure on pages 4 and 122 that you have raised $418
million in equity
capital "from a group of premier life sciences investors[.]" Please
limit your disclosure of
specific investors to those identified in the Principal Stockholder
table on page 194.
Additionally, please indicate that prospective investors should not
rely on the named
investors investment decisions and that these investors may have
different investment
strategies and risk tolerances.
We also note that on page 103 you state that you have received gross
proceeds of
approximately $418 million from the sale of your convertible preferred
stock. If true,
please disclose here, and elsewhere as appropriate, that the preferred
stock offering(s) in
which such investors purchased shares were conducted at a significant
discount to the IPO
price.
Ken Song, M.D.
FirstName LastNameKen Song, M.D.
RayzeBio, Inc.
Comapany
July NameRayzeBio, Inc.
20, 2023
July 20,
Page 3 2023 Page 3
FirstName LastName
Our strategy, page 5
7. We note that one of the key elements of your strategy is to "[b]uild
the market leading
sustainable SSTR2 franchise in multiple cancers." This implies the
likelihood of
regulatory approval and comparisons to other products and product
candidates. This
statement is speculative in light of your product candidates'
regulatory status, please
remove the references to building a market leading franchise. We also
note your
disclosure that RYZ101 has "applicability across several cancer
indications." Please
clarify here, and elsewhere as appropriate, that, to date, RYZ101 has
not yet received
FDA approval for the treatment of any cancer indications or,
alternatively, please remove
your reference to RYZ101's "applicability across several cancer
indications."
Risk Factors
Risks related to our limited operating history, financial condition and need
for additional capital
Our limited operating history may make it difficult for you to evaluate our
prospects and
likelihood of success, page 12
8. We note your disclosure here that you "have not demonstrated [y]our
ability to
successfully complete any clinical trials[.]" Please clarify
throughout your registration
statement, including in the prospectus summary and business sections,
how you were able
to obtain an IND for a Phase 3 trial even though, according to your
disclosure, you have
not yet demonstrated the ability to successfully complete any clinical
trials. To the extent
that you have not completed any clinical trials to date please revise
your pipeline tables on
pages 2 and 119 to make this clear.
Risks related to our dependence on third parties
We may be unable to obtain a sufficient supply of radioisotopes to support
clinical development
or manufacturing at commercial scale, page 48
9. We note your disclosure here that one of your suppliers of Ac224 is
located in
Russia, your dependence on this supplier is increased in the near
term, and you must rely
on your supplier in Russia for your international operations. Please
revise to discuss
whether the conflict between Russia and Ukraine has impacted you
ability to source this
supply and its cost.
Results of Operations
Research and Development Expenses, page 108
10. For each period presented, please revise to provide a breakdown of the
amount of research
and development expense incurred for each of your lead product
candidates by program.
For product candidates with more than one application, provide a
breakdown by
indication. To the extent that you do not track expenses by product
candidate, program, or
indication, please disclose that fact and explain why you do not
maintain and evaluate
research and development cost in this manner. For all unallocated
research and
Ken Song, M.D.
FirstName LastNameKen Song, M.D.
RayzeBio, Inc.
Comapany
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development expense, provide a breakdown by type or nature of expense
such that the
sum reconciles to total research and development expense for the
period.
Business
Overview, page 116
11. We note your disclosure that "[b]y using the RPT construct as a
diagnostic imaging agent,
one can visualize in each patient the uptake of the RPT construct in
tumor and normal
tissues to appropriately select those patients who would more likely
benefit from
treatment of a therapeutic radioisotope." Please revise your
disclosure here, and
elsewhere as appropriate, to note whether the FDA, to date, has
approved the use of the
RPT construct as a diagnostic imaging agent. In this regard, we note
your disclosure on
page 20 that your "development of a diagnostic imaging agent will be
subject to FDA
review and approval[.]"
Our Strategy, page 122
12. We note your statement on page 122: "RYZ101 is enrolling in a Phase 3
clinical trial in
patients with refractory GEP-NETs, having demonstrated a favorable
safety profile in the
Phase 1b portion of the ACTION-1 trial." Please revise this and any
similar statements in
your prospectus that state or imply that your development product
candidates are safe as
this determination is solely within the authority of the FDA and
comparable regulatory
bodies. We would not object if you state that the treatment was
well-tolerated.
Phase 1b portion of the ACTION-1 trial in patients with GEP-NETs, page 127
13. On page 52 you state that you took advantage of the opportunity to
have physicians
administer RYZ101 under a compassionate use program and that the
starting dose for your
ACTION-1 trial for GEP-NETs was selected based on prior clinical
experience with
Ac225 DOTATATE outside the United States via compassionate use. On
page 26 you
state that prior clinical experience in treating patients with
GEP-NETs with Ac225
DOTATATE, the same active ingredient as RYZ101, has been presented by
an academic
nuclear medicine group and, on page 126, that academic medical
centers outside the
United States have already demonstrated clinical response using Ac225
DOTATATE in
patients with GEP-NETs. Please revise to clarify the development of
Ac225
DOTATATE and RYZ-101, including the data produced by third parties and
through your
compassionate use program.
RYZ801 clinical development plans, page 135
14. We note your disclosure that "several clinical sites outside of the
United States have
imaged a total of 14 HCC patients with [y]our binder." Please revise
your disclosure here
to note whether any serious adverse events were observed during the
imaging of the HCC
patients.
Ken Song, M.D.
RayzeBio, Inc.
July 20, 2023
Page 5
License Agreement with Ablaze Pharmaceuticals Inc., page 140
15. We note your disclosure that Ablaze has agreed to pay you up to a
percentage in the "low
double digits" of certain sublicense revenue it receives, depending on
the time when the
sublicense agreement is executed. Please revise your description of
this sublicense
revenue percentage to a figure within ten percentage points. We also
note that
the maximum number of selected products under the Ablaze Agreement is
limited to a
certain number and Ablaze s right to select products will expire
upon the earlier of (a)
Ablaze selecting the maximum number of products allowed to be selected
under the
agreement; (b) you presenting a certain number of products for
consideration by Ablaze to
license or (c) a certain date. Please revise to provide the "certain
date."
License and Research Collaboration Agreement with PeptiDream, Inc., page 141
16. We note your disclosure that certain royalty payments set forth in the
PeptiDream
Agreement could be reduced by a percentage in the "low double digits"
or "mid-double
digits," that you must pay some percentages in the "low
double-digit[s,]" and that there is
a commitment from PeptiDream to enter into good faith business
discussions concerning
the funding of up to a percentage in the "mid-double digits" of the
costs related to IND-
enabling studies, manufacturing of clinical supply and clinical trials
for certain licensed
products. For each of these percentages, please revise to a figure
that is within ten
percentage points.
We also note your statement on page 141: "Unless earlier terminated,
the PeptiDream
Agreement will expire on the first to occur of (a) the instance that,
at any time from and
after the expiration of the research term, there are no selected
conjugates under active
development or commercialization by us or (b) on a licensed
product-by-licensed product
and country-by-country basis upon the expiration of the applicable
royalty term for such
licensed product." Please revise to provide the royalty term(s).
General
17. Please tell us why the agreement with Niowave, Inc. was deleted from
the prospectus
disclosure and considered not a material contract required to be filed
under Item
601(b)(10) of Regulation S-K.
18. Please provide us with copies of all written communications, as defined
in Rule 405 under
FirstName LastNameKen Song, M.D.
the Securities Act, that you, or anyone authorized to do so on your
behalf, present to
Comapany NameRayzeBio,
potential investors in Inc.
reliance on Section 5(d) of the Securities Act,
whether or not they
July 20,retain
2023copies
Page 5of the communications
FirstName LastName
Ken Song, M.D.
FirstName LastNameKen Song, M.D.
RayzeBio, Inc.
Comapany
July NameRayzeBio, Inc.
20, 2023
July 20,
Page 6 2023 Page 6
FirstName LastName
You may contact Gary Newberry at 202-551-3761 or Kevin Vaughn at
202-551-3494 if
you have questions regarding comments on the financial statements and related
matters. Please
contact Joshua Gorsky at 202-551-7836 or Margaret Schwartz at 202-551-7153 with
any other
questions.
Sincerely,
Division of
Corporation Finance
Office of Life
Sciences
cc: Terren J. O'Connor, Esq.