United States securities and exchange commission logo
November 21, 2023
Peter Maag, Ph.D.
Chief Executive Officer
Kyverna Therapeutics, Inc.
5980 Horton St., STE 550
Emeryville, CA 94608
Re: Kyverna
Therapeutics, Inc.
Amendment No. 1 to
Draft Registration Statement on Form S-1
Submitted November
9, 2023
CIK No. 0001994702
Dear Peter Maag:
We have reviewed your amended 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.
Amendment No. 1 to Draft Registration Statement submitted November 9,
2023
Prospectus Summary
Overview, page 1
1. We note your response
to comment 1 and reissue. Your disclosure on page 1 stating
KYV-101 is "based on a
[CAR] that has completed a 20-patient Phase 1 trial in oncology
conducted by the
National Institutes of Health" makes it appear that KYV-101 may not be
the same product
candidate used by the NIH in its Phase 1 trial. Please revise to disclose
what technology you
have developed versus what technology you have in-licensed. To the
extent KYV-101 and the
NIH product candidate differ, revise to disclose why it is
appropriate to discuss
the results from the NIH Phase 1 trial to support your proof of
concept.
Peter Maag, Ph.D.
FirstName LastNamePeter
Kyverna Therapeutics, Inc.Maag, Ph.D.
Comapany 21,
November NameKyverna
2023 Therapeutics, Inc.
November
Page 2 21, 2023 Page 2
FirstName LastName
2. We note your disclosure that the differentiated properties of KYV-101,
which was
designed with a fully human single-chain fragment variable, are
critical for the potential
success of CAR T cells as autoimmune disease therapies, and we note
your disclosure that
you believe that the favorable profile of KYV-101 has the potential to
be critical for the
application of CAR T-cell therapies in indications such as autoimmune
diseases. In this
regard, we note your inclusion of data from the Schett Group case
series and the
disclosure on page 134 that patients with autoimmune diseases have
been observed to
tolerate treatment with CAR T-cell therapies without experiencing the
Grade 3 and above
CRS and ICANS adverse events seen in oncology trials. If known,
explain the
understanding of the tolerability of CAR T-cell therapy in patients
with autoimmune
diseases. For example, if in patients with B cell malignancies, where
patients presumably
have higher B cell counts, the higher proportion of CRS and ICANS can
be explained by a
higher number of B cells being depleted by the treatment than would be
the case in
autoimmune patients, please clarify the competitive advantage of your
fully human single-
chain fragment variable, or explain what other differentiated
properties, or other aspects of
the favorable profile, of KYV-101 provide you with a competitive
advantage. We note, in
this regard, the design goals described in the second paragraph on
page 123 which do not
appear to be mentioned in your summary. Also, please indicate in your
disclosure on page
134 whether the Schett Group case series involved more fully humanized
CAR T
therapies than the therapies used in the DLBCL indications.
Translating transformational oncology experience with cell therapies to
autoimmune diseases,
page 2
3. As requested by comment 2, please indicate whether statistically
meaningful conclusions
can be drawn at this time from the clinical data referenced in the
third paragraph of this
section.
Our pipeline and programs, page 3
4. We note your response to comment 11 and reissue in part. Please revise
your pipeline
tables on pages 3 and 115 to disclose the undisclosed indication for
your CAR T & Other
Approaches program and expand the discussion on page 116 to discuss
your research
supporting your statement that "the use of antigen-specific T-regs,
possibly through use of
a CAR, holds promise by enhancing homing to antigen-specific effector
T cells or sites of
inflammation." We also note you now depict the clinical progress of
two different studies
for KYV-101's lupus nephritis indication in your pipeline table,
including a progress bar
for approval in Europe. Please revise to remove the individual study
progress rows and
revert to a single row depicting the overall current phase of
development for the program
as it appears from your disclosure that you are not currently pursuing
regulatory approval
in Europe but only conducting clinical trials in Europe. Revise to
include a footnote
disclosing that KYV-101's Fast Track designation in lupus nephritis
does not assure that
you will experience a faster development process, regulatory review or
regulatory
approval process compared to conventional FDA procedures as you
disclose on page 58.
Peter Maag, Ph.D.
Kyverna Therapeutics, Inc.
November 21, 2023
Page 3
5. We note your revised disclosure in response to comment 13. For the study
you reference,
please clarify what models were used for the in vivo comparisons, for
example, mice or
humans.
Systemic Sclerosis (SSc) Disease Overview, page 129
6. We note your revisions in response to comment 15. Please continue to
revise to discuss
the clinical development of KYV-101 for systemic sclerosis. Disclose the
trial design,
number of patients, and primary and secondary endpoints.
Notes to Financial Statements
6. Significant Agreements, page F-16
7. We note your response to prior comment 25 and the revised disclosure.
Please revise to
clarify whether the entire amount is now due upon the consummation of a
qualified
financing. Also, clarify the disclosure on page 100 for when the $6.3
million is due.
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 21, 2023 Page 3
cc: Jeffrey T. Hartlin, Esq.
FirstName LastName