United States securities and exchange commission logo
November 1, 2023
Peter Maag, Ph.D.
Chief Executive Officer
Kyverna Therapeutics, Inc.
5980 Horton St., STE 550
Emeryville, CA 94608
Re: Kyverna
Therapeutics, Inc.
Draft Registration
Statement on Form S-1
Submitted October
5, 2023
CIK No. 0001994702
Dear Peter Maag:
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 S-1 submitted October 5, 2023
Prospectus Summary
Overview, page 1
1. We note your disclosure
that you aim to bring transformational change to this field by
applying your
proprietary technology. We also note your disclosure on page 4 that the
CAR T cells created
with Hu19-CD828Z, the humanized CAR, used by the NCI in its
clinical study is
the same CAR [you] use to create KYV-101. Please revise to disclose
what technology you
have developed versus what technology you have in-licensed.
2. Please revise pages 1,
95 and 113 to describe the several published case studies
supporting your
conclusion that your early insights and investments into the potential
benefits of cell
therapies in autoimmune diseases have been validated. State whether the
studies were conducted
in relation to autoimmune diseases and disclose the number of
patients in the case
studies and whether statistically meaningful conclusions can be drawn
Peter Maag, Ph.D.
FirstName LastNamePeter
Kyverna Therapeutics, Inc.Maag, Ph.D.
Comapany 1,
November NameKyverna
2023 Therapeutics, Inc.
November
Page 2 1, 2023 Page 2
FirstName LastName
at this time. Revise your disclosure on pages 3 and 118 to remove the
statement that recent
publications using CD19 CAR T cells resulted in robust and durable
responses. You
may disclose and discuss the data supporting your conclusions.
3. Please revise here and elsewhere as appropriate to describe your
patient-centered
approach.
4. We note your disclosure on page 1 that KYV-101 was observed to have
improved
tolerability in the clinic. Revise to disclose what KYV-101 s
tolerability was compared
to and in what patient population. We also note your disclosure that
KYV-101 was created
using a CAR designed by the NIH to improve tolerability through the
use of a fully human
CD19 binding domain and optimized hinge and transmembrane domains. If
this is the
factor that improves tolerability, please disclose this upfront and
revise to indicate any
other factors that lead you to believe that KYV-101 may have improved
tolerability.
5. We note your disclosure on page 1 that you believe lupus nephritis is
an attractive lead
indication in part because of prior clinical validation of the
potential of CD19 CAR T
cells in this indication. Please revise to clarify the prior
clinical validation that you are
referring to and, in an appropriate location, include and discuss the
objective data from
previous clinical trials that support your conclusion.
KYV-201, an Allogeneic CD19 CAR T-cell Product Candidate, page 2
6. Please revise pages 2 and 132 to disclose the jurisdiction where you
intend to file a CTA
for KYV-201.
Our Solution - Cell Therapy for Autoimmune Disease Treatment, page 2
7. Please revise to remove your disclosure on pages 3 and 118 stating
the clinical and
regulatory paths established in these indications highlight the
breakthrough potential of
cell therapies in autoimmune diseases as it appears to be
speculative.
Our Strategy, page 2
8. Please revise to remove your references to developing best-in-class
product candidates
appearing on page 2 and elsewhere in your Prospectus as such
statements are speculative
given your stage of development.
9. We note your reference to Gilead in the summary section. However, we
note from your
disclosure on page 137 that on November 30, 2022, after the completion
of research
activities under Program A and Program B, Gilead provided you with
notice that Program
A and Program B were terminated and that there are currently no other
active programs
under the Gilead Agreement. Although we note that your research-stage
programs are
focused on developing product candidates that you believe will be
required to treat other
autoimmune diseases, and that these programs include a suite of
capabilities related to
regulatory T cells, or T-regs, developed through your completed
research collaboration
with Gilead, these research programs do not appear to be material at
this time. As such,
Peter Maag, Ph.D.
Kyverna Therapeutics, Inc.
November 1, 2023
Page 3
please remove your references to Gilead in the summary section or
revise your disclosure
to make clear how that completed collaboration and related programs
are material at this
time.
10. Please balance the disclosure in the fourth bullet point of this
section to indicate, if true,
that you do not expect to be able to use the results from any
investigator initiated trials
conducted with your product candidates in any regulatory submission
for marketing
approval.
Our Pipeline, page 3
11. Please make the following changes to your pipeline tables appearing on
pages 3 and 120:
Add a Clinical Phase 3 column; and
Remove your CAR T & Other Approaches row as it appears
immaterial given the
minimal discussion of this program within your Prospectus.
Alternatively, revise your
Business section to provide additional detail about this program
that supports why it
is a material technology for purposes of inclusion in your
pipeline tables and revise
your pipeline tables to disclose the indication.
KYV-101, an Autologous CD19 CAR T-cell Product Candidate for Rheumatology and
Neurology Indications, page 4
12. Please revise where you state on page 4 that there are clinical
results from individual
patients treated with KYV-101 in MS to disclose the results of the
clinical studies, the
phase of clinical development, and whether the results are
statistically significant.
13. We note your disclosure that Hu19-CD828Z "was found" to reduce the
levels of cytokine
release in a systematic comparison of CARs created with alternate
domain structures,
including the FMC63-CD28Z CAR used to create Yescarta . Revise to
clarify the data on
which this finding was based, the statistical significance of that
data and who made this
finding. In this regard, we note your disclosure later on this page
regarding twenty patients
with B-cell lymphoma that had undergone four prior lines of therapy.
If the finding you
reference is based on this patient population, please include
cautionary disclosure about
the applicability of this finding in the context of the patient
populations, prior treatments
and indications you are pursuing.
KYV-101, Designed for Improved Efficacy and Safety, page 4
FirstName LastNamePeter Maag, Ph.D.
14. Please revise your headings on pages 4 and 121 stating KYV-101 is
designed for
Comapany NameKyverna
improved efficacy andTherapeutics, Inc. create an improper inference
that your product
safety as they
candidate
November is Page
1, 2023 safe, 3effective and superior to existing approved
products.
FirstName LastName
Peter Maag, Ph.D.
FirstName LastNamePeter
Kyverna Therapeutics, Inc.Maag, Ph.D.
Comapany 1,
November NameKyverna
2023 Therapeutics, Inc.
November
Page 4 1, 2023 Page 4
FirstName LastName
Summary of KYV-101 Clinical Development, page 4
15. Please revise here to discuss the clinical development of KYV-101.
Disclose the
indications, phases of clinical development, regulatory jurisdictions
where the trials are
being conducted, trial design, number of patients, primary and
secondary endpoints and
when you started dosing patients.
Manufacturing Capabilities and Industrialization of Autologous CAR T-cell
Therapies, page 5
16. We note your disclosure on pages 4 and 131 stating five patients
have consented to
treatment and manufacturing of KYV-101 for these patients has
initiated appears to
conflict with your disclosure on page 5 stating you have
successfully manufactured all
needed clinical supply for clinical sites in both the United States
and Germany. Please
revise or otherwise advise. Revise to disclose the contract
development and manufacturing
organization that will generate KYV-101 for near-term clinical trials
and disclose
the world-class organizations in cell therapy manufacturing you
partnered with for the
Ingenui-T manufacturing process.
The Offering, page 9
17. Please revise page 9 and your Use of Proceeds Section to disclose how
far through clinical
development you expect to get using the proceeds from this offering
for KYV-101 and
KYV-201 in each indication.
Management's Discussion and Analysis of Financial Condition and Results of
Operations, page
95
Results of Operations, page 103
18. Regarding the table of external costs by program on page 104, please
revise to explain the
nature of Other programs and research and development activities,
which appears to be
significant to your external research and development expense in each
annual period.
Business
Overview, page 113
19. We note your disclosure that you believe your CAR T-cell therapies may
present a
significant advantage over current standard-of-care therapies by
aiming to directly deplete
B cells and potentially resetting disease-contributing B cells. In an
appropriate location,
please disclose your current understanding of the biological process
that may lead to this
potential for reset of the immune system and disclose whether the
conclusions to be drawn
from that understanding are based on statistically significant data at
this time.
KYV-101 Clinical Development in Lupus Nephritis, page 126
20. Please revise to provide the material details and parameters of your
current clinical trials
for Lupus Nephritis, including primary and secondary endpoints,
metrics utilized,
Peter Maag, Ph.D.
FirstName LastNamePeter
Kyverna Therapeutics, Inc.Maag, Ph.D.
Comapany 1,
November NameKyverna
2023 Therapeutics, Inc.
November
Page 5 1, 2023 Page 5
FirstName LastName
including the clinically meaningful improvements and objective
clinical endpoints
referred to on page 114.
Clinical Results of KYV-101 Treatment in MG, page 128
21. Please revise here to disclose the circumstance by which the patient
was permitted to be
treated with KYV-101.
Our Collaboration and License Agreements, page 134
22. For the low double-digit percentage for the sublicense royalty
under the NIH
Agreements, please revise to disclose the upper range of this
percentage so that it is
expressed at no greater than 10 percentage points. For the Kite
Agreement, please revise
to disclose aggregate payments made to date, the aggregate future
milestone payments
payable, and a range of no greater than 10 percentage points for the
minimum annual
royalty rates payable, under the Kite Agreement.
Gilead Collaboration, Option and License Agreement, page 136
23. You disclose that pursuant to the Gilead Agreement, you and Gilead
will collaborate to
develop potential cell-based therapy products. Given your disclosure
that there are no
current active programs under the Gilead Agreement, please provide an
expected
timeframe for these development activities or revise your disclosure
as appropriate.
Intellectual Property, page 139
24. Please revise starting on page 139 to disclose, for each material
patent family, the
technologies to which the patents relate, whether the patents are
owned or licensed, the
type of patent protection, patent expiration dates, expected
expiration dates for pending
patent applications and jurisdictions.
Notes to Financial Statements
6. Significant Agreements
Kite License Agreement (Related Party), page F-17
25. You disclose that the current accrued license expense is based on when
milestone
payments under the Gilead Agreement will be due and a liability can be
offset. Please tell
us how you determined when the milestone payments will be due.
General
26. Please provide us with supplemental 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,
have presented or expect to present to potential investors in reliance
on Rule 163B of the
Securities Act, whether or not you retained, or intend to retain,
copies of those
communications.
Peter Maag, Ph.D.
Kyverna Therapeutics, Inc.
November 1, 2023
Page 6
Please contact Jenn Do at 202-551-3743 or Vanessa Robertson at
202-551-3649 if you
have questions regarding comments on the financial statements and related
matters. Please
contact Daniel Crawford at 202-551-7767 or Tim Buchmiller at 202-551-3635 with
any other
questions.
Sincerely,
FirstName LastNamePeter Maag, Ph.D.
Division of
Corporation Finance
Comapany NameKyverna Therapeutics, Inc.
Office of Life
Sciences
November 1, 2023 Page 6
cc: Jeffrey T. Hartlin, Esq.
FirstName LastName