SEC Comment Letter 0000000000-23-011959 to Kyverna Therapeutics, Inc. (KYTX)
Kyverna Therapeutics, Inc.
Date: Nov. 1, 2023 · CIK: 0001994702 · Accession: 0000000000-23-011959
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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
FirstName LastNamePeter Maag, Ph.D.
Comapany NameKyverna Therapeutics, Inc.
November 1, 2023 Page 2
FirstName LastNamePeter Maag, Ph.D.
Kyverna Therapeutics, Inc.
November 1, 2023
Page 2
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,
FirstName LastNamePeter Maag, Ph.D.
Comapany NameKyverna Therapeutics, Inc.
November 1, 2023 Page 3
FirstName LastName
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
14.Please revise your headings on pages 4 and 121 stating KYV-101 is “designed for
improved efficacy and safety” as they create an improper inference that your product
candidate is safe, effective and superior to existing approved products.
FirstName LastNamePeter Maag, Ph.D.
Comapany NameKyverna Therapeutics, Inc.
November 1, 2023 Page 4
FirstName LastName
Peter Maag, Ph.D.
Kyverna Therapeutics, Inc.
November 1, 2023
Page 4
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,
FirstName LastNamePeter Maag, Ph.D.
Comapany NameKyverna Therapeutics, Inc.
November 1, 2023 Page 5
FirstName LastNamePeter Maag, Ph.D.
Kyverna Therapeutics, Inc.
November 1, 2023
Page 5
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.
FirstName LastNamePeter Maag, Ph.D.
Comapany NameKyverna Therapeutics, Inc.
November 1, 2023 Page 6
FirstName LastName
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,
Division of Corporation Finance
Office of Life Sciences
cc: Jeffrey T. Hartlin, Esq.