SecProbe.io

Filing text and metadata
Intelligence Terminal Search Topics Monthly Activity About

SEC Comment Letter 0000000000-23-014149 to Kyverna Therapeutics, Inc. (KYTX)

Kyverna Therapeutics, Inc.
Date: Dec. 28, 2023 · CIK: 0001994702 · Accession: 0000000000-23-014149

AI Filing Summary & Sentiment

Sentiment
Urgency
Document Type
Confidence
SEC Posture
Company Posture

Summary

Reasoning

Date
December 28, 2023
Author
Peter Maag, Ph.D.
Form
UPLOAD
Company
Kyverna Therapeutics, Inc.

Letter

United States securities and exchange commission logo December 28, 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. 2 to Draft Registration Statement on Form S-1 Submitted December 13, 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. 2 to Draft Registration Statement on Form S-1 submitted December 13, 2023 Prospectus Summary Overview, page 1 1.We note your response to comment 1 and reissue in part. Your disclosure on page 1 stating that KYV-101 "includes" a CAR you licensed from the NIH may make it appear that KYV-101 contains technology that is in addition to the technology developed by the NIH. Please revise to disclose what technology you have developed and that is included in KYV-101 versus the technology you have in-licensed. To the extent that KYV-101 does not include technology that you have developed, please revise here and elsewhere throughout to clearly state this.

FirstName LastNamePeter Maag, Ph.D. Comapany NameKyverna Therapeutics, Inc. December 28, 2023 Page 2 FirstName LastName Peter Maag, Ph.D. Kyverna Therapeutics, Inc. December 28, 2023 Page 2 Our pipeline and programs, page 3 2.We note your response to comment 4 and reissue in part. We note your disclosure throughout stating you are conducting a clinical trial in Germany, your disclosure on page 52 that you are conducting clinical trials “outside the United States, and the FDA and comparable foreign regulatory authorities may not accept data from such trials” and your disclosure on page 53 that you “plan to seek regulatory approval of [y]our current or future product candidates outside of the United States.” We also note your disclosure on page 163 that “[i]n addition to regulations in the United States, [you] may be subject to a variety of regulations in other jurisdictions that [you] may in the future select, which may govern, among other things, clinical trials and any commercial sales and distribution of [y]our products.” In regard to this, it appears you are conducting a clinical trial in Germany and intend to submit the study data to the FDA and plan to seek regulatory approval in Europe at another time. The pipeline table should depict the current overall progress of each product candidate in each indication. Please revise to remove the individual study progress rows from your depiction of KYV-101 in lupus nephritis and revert to a single row depicting the overall current phase of development for the program. We do not object to the current pipeline table presentation to the extent you are currently and simultaneously pursuing regulatory approval of KYV-101 in lupus nephritis in the United States and Europe and do not intend to use data from your trials conducted in the United States to submit to European regulators or vice versa. If true, revise throughout to state as much and revise your disclosure starting on page 163 to provide a full discussion of the regulatory approval process in the foreign jurisdictions you are currently seeking regulatory approval and reconcile your disclosure throughout to reflect you are currently seeking regulatory approval in foreign jurisdictions as opposed to planning to do so in the future. Finally, please revise your pipeline tables here and elsewhere to enlarge the footnote so it is legible. Risk Factor Summary, page 6 3.We note your new risk factor disclosure starting on page 54 related to the FDA's November 28, 2023 statement. Please revise here to include summary risk factor disclosure. Critical Accounting Estimates Determination of Fair Value of Common Stock, page 113 4.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. Please discuss with the staff how to submit your response.

FirstName LastNamePeter Maag, Ph.D. Comapany NameKyverna Therapeutics, Inc. December 28, 2023 Page 3 FirstName LastName Peter Maag, Ph.D. Kyverna Therapeutics, Inc. December 28, 2023 Page 3 Notes to Financial Statements 6. Significant Agreements, page F-16 5.We note your response to prior comment 7 and the revised disclosure. Please revise your disclosure to clarify the timing of when the current accrued license expense-related party balance of $6.3 million is due. Notes to Condensed Financial Statements (unaudited) 14. Subsequent Events, page F-55 6.Please quantify the amount of the stock compensation expense you expect to recognize for the option grants issued subsequent to September 30, 2023. 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.

Show Raw Text
United States securities and exchange commission logo
December 28, 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. 2 to Draft Registration Statement on Form S-1
Submitted December 13, 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. 2 to Draft Registration Statement on Form S-1 submitted December 13, 2023
Prospectus Summary
Overview, page 1
1.We note your response to comment 1 and reissue in part. Your disclosure on page 1
stating that KYV-101 "includes" a CAR you licensed from the NIH may make it appear
that KYV-101 contains technology that is in addition to the technology developed by the
NIH. Please revise to disclose what technology you have developed and that is included in
KYV-101 versus the technology you have in-licensed. To the extent that KYV-101 does
not include technology that you have developed, please revise here and elsewhere
throughout to clearly state this.

 FirstName LastNamePeter Maag, Ph.D.
 Comapany NameKyverna Therapeutics, Inc.
 December 28, 2023 Page 2
 FirstName LastName
Peter Maag, Ph.D.
Kyverna Therapeutics, Inc.
December 28, 2023
Page 2
Our pipeline and programs, page 3
2.We note your response to comment 4 and reissue in part. We note your disclosure
throughout stating you are conducting a clinical trial in Germany, your disclosure on page
52 that you are conducting clinical trials “outside the United States, and the FDA and
comparable foreign regulatory authorities may not accept data from such trials” and your
disclosure on page 53 that you “plan to seek regulatory approval of [y]our current or
future product candidates outside of the United States.” We also note your disclosure on
page 163 that “[i]n addition to regulations in the United States, [you] may be subject to a
variety of regulations in other jurisdictions that [you] may in the future select, which may
govern, among other things, clinical trials and any commercial sales and distribution of
[y]our products.” In regard to this, it appears you are conducting a clinical trial in
Germany and intend to submit the study data to the FDA and plan to seek regulatory
approval in Europe at another time. The pipeline table should depict the current overall
progress of each product candidate in each indication. Please revise to remove the
individual study progress rows from your depiction of KYV-101 in lupus nephritis and
revert to a single row depicting the overall current phase of development for the program.
We do not object to the current pipeline table presentation to the extent you are currently
and simultaneously pursuing regulatory approval of KYV-101 in lupus nephritis in the
United States and Europe and do not intend to use data from your trials conducted in the
United States to submit to European regulators or vice versa. If true, revise throughout to
state as much and revise your disclosure starting on page 163 to provide a full discussion
of the regulatory approval process in the foreign jurisdictions you are currently seeking
regulatory approval and reconcile your disclosure throughout to reflect you are currently
seeking regulatory approval in foreign jurisdictions as opposed to planning to do so in the
future. Finally, please revise your pipeline tables here and elsewhere to enlarge the
footnote so it is legible.
Risk Factor Summary, page 6
3.We note your new risk factor disclosure starting on page 54 related to the FDA's
November 28, 2023 statement. Please revise here to include summary risk factor
disclosure.
Critical Accounting Estimates
Determination of Fair Value of Common Stock, page 113
4.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. Please discuss with the staff how to submit your response.

 FirstName LastNamePeter Maag, Ph.D.
 Comapany NameKyverna Therapeutics, Inc.
 December 28, 2023 Page 3
 FirstName LastName
Peter Maag, Ph.D.
Kyverna Therapeutics, Inc.
December 28, 2023
Page 3
Notes to Financial Statements
6. Significant Agreements, page F-16
5.We note your response to prior comment 7 and the revised disclosure. Please revise your
disclosure to clarify the timing of when the current accrued license expense-related party
balance of $6.3 million is due.
Notes to Condensed Financial Statements (unaudited)
14. Subsequent Events, page F-55
6.Please quantify the amount of the stock compensation expense you expect to recognize for
the option grants issued subsequent to September 30, 2023.
            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.