United States securities and exchange commission logo
March 10, 2022
Ken Song, M.D.
President and Chief Executive Officer
RayzeBio, Inc.
5505 Morehouse Drive, Suite 300
San Diego, CA 92121
Re: RayzeBio, Inc.
Draft Registration
Statement on Form S-1
Submitted February
11, 2022
CIK No. 0001825367
Dear Mr. Song:
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.
Draft Registration Statement on Form S-1 submitted February 11, 2022
Leveraging our development ecosystem to build a sustainable enterprise
of value creation, page 3
1. We note your disclosure
that your "lead clinical drug candidate, RYZ101 for GEP-NET
patients in which
clinical data from one center supports potential efficacy and safety of
Ac225 DOTATE." Please
revise this statement to eliminate conclusions or predictions
that your lead clinical
drug candidate is safe and effective as determinations of safety and
efficacy are solely
within the authority of the FDA.
Our programs, page 3
2. We note your disclosure
that you have "applied [y]our parallel discovery engine to build a
diverse portfolio of
potential TRP drug candidates that spans discovery to early clinical
Ken Song, M.D.
FirstName LastNameKen Song, M.D.
RayzeBio, Inc.
Comapany
March NameRayzeBio, Inc.
10, 2022
March2 10, 2022 Page 2
Page
FirstName LastName
stage." Given that you currently have one drug candidate, RYZ101,
which is currently in
Phase 1 clinical trials for one indication and in the pre-clinical
stage for another
indication, please explain how your portfolio of potential drug
candidates can be described
as "diverse."
We intend to seek orphan drug designation for RYZ 101..., page 34
3. We note your disclosure that you intend to seek orphan drug
designation for RYZ101 for
the treatment of GEP-NET patients that have progressive disease
following treatment with
Lu177 SSA therapy. Please clarify whether, in your estimation,
obtaining orphan drug
status will be required for you to achieve profitability. If so,
please revise your risk factor
disclosure accordingly.
We may be unable to obtain a sufficient supply of radioisotopes to support
clinical development
or manufacturing at commercial scale, page 49
4. We note your disclosure that one of your suppliers of Ac225 is located
in Russia. Please
describe the impact of Russia's invasion of Ukraine on your business,
including the impact
of any restrictions on trade between the United States and Russia.
Our amended and restated certificate of incorporation that will be effective
upon the closing of
this offering will designate..., page 80
5. Please disclose here and on page 194 that your exclusive forum
provision may raise
questions of enforceability because it does not afford concurrent
jurisdiction provided by
Section 22 of the Securities Act. Please also disclose that such an
exclusive forum
provision may increase the cost for an investor to bring a claim
against you.
Management's discussion and analysis of financial condition and results of
operation
Stock-based compensation expense, page 107
6. 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
up to the initial public offering and the estimated offering price.
This information will
help facilitate our review of your accounting for equity issuances
including stock
compensation and beneficial conversion features. Please discuss with
the staff how to
submit your response.
Intellectual Property, page 131
7. Please clarify the types of patent protection you have applied for
(i.e., composition of
matter, use, or process).
General
8. Please provide us with copies of all written communications, as
defined in Rule 405 under
Ken Song, M.D.
RayzeBio, Inc.
March 10, 2022
Page 3
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.
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 Celeste Murphy at 202-551-3257 with
any other
questions.
FirstName LastNameKen Song, M.D. Sincerely,
Comapany NameRayzeBio, Inc.
Division of
Corporation Finance
March 10, 2022 Page 3 Office of Life
Sciences
FirstName LastName