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Kyverna Therapeutics, Inc.
Response Received
1 company response(s)
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Kyverna Therapeutics, Inc.
Response Received
1 company response(s)
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Kyverna Therapeutics, Inc.
Awaiting Response
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SEC wrote to company
2024-07-11
Kyverna Therapeutics, Inc.
Summary
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Kyverna Therapeutics, Inc.
Response Received
4 company response(s)
Medium - date proximity
SEC wrote to company
2024-01-10
Kyverna Therapeutics, Inc.
Summary
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Company responded
2024-01-16
Kyverna Therapeutics, Inc.
References: January 10, 2024
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Company responded
2024-01-25
Kyverna Therapeutics, Inc.
References: December 28, 2023
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Company responded
2024-02-05
Kyverna Therapeutics, Inc.
Summary
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Company responded
2024-02-05
Kyverna Therapeutics, Inc.
Summary
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Kyverna Therapeutics, Inc.
Awaiting Response
0 company response(s)
High
SEC wrote to company
2023-12-28
Kyverna Therapeutics, Inc.
Summary
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Kyverna Therapeutics, Inc.
Awaiting Response
0 company response(s)
High
SEC wrote to company
2023-11-21
Kyverna Therapeutics, Inc.
Summary
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Kyverna Therapeutics, Inc.
Awaiting Response
0 company response(s)
High
SEC wrote to company
2023-11-01
Kyverna Therapeutics, Inc.
Summary
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Summary
| Date | Type | Company | Location | File No | Link |
|---|---|---|---|---|---|
| 2026-03-31 | Company Response | Kyverna Therapeutics, Inc. | DE | N/A | Read Filing View |
| 2026-03-30 | SEC Comment Letter | Kyverna Therapeutics, Inc. | DE | 333-294645 | Read Filing View |
| 2025-04-11 | Company Response | Kyverna Therapeutics, Inc. | DE | N/A | Read Filing View |
| 2025-04-01 | SEC Comment Letter | Kyverna Therapeutics, Inc. | DE | 333-286180 | Read Filing View |
| 2024-07-11 | SEC Comment Letter | Kyverna Therapeutics, Inc. | DE | 005-94441 | Read Filing View |
| 2024-02-05 | Company Response | Kyverna Therapeutics, Inc. | DE | N/A | Read Filing View |
| 2024-02-05 | Company Response | Kyverna Therapeutics, Inc. | DE | N/A | Read Filing View |
| 2024-01-25 | Company Response | Kyverna Therapeutics, Inc. | DE | N/A | Read Filing View |
| 2024-01-16 | Company Response | Kyverna Therapeutics, Inc. | DE | N/A | Read Filing View |
| 2024-01-10 | SEC Comment Letter | Kyverna Therapeutics, Inc. | DE | 377-06910 | Read Filing View |
| 2023-12-28 | SEC Comment Letter | Kyverna Therapeutics, Inc. | DE | 377-06910 | Read Filing View |
| 2023-11-21 | SEC Comment Letter | Kyverna Therapeutics, Inc. | DE | 377-06910 | Read Filing View |
| 2023-11-01 | SEC Comment Letter | Kyverna Therapeutics, Inc. | DE | 377-06910 | Read Filing View |
| Date | Type | Company | Location | File No | Link |
|---|---|---|---|---|---|
| 2026-03-30 | SEC Comment Letter | Kyverna Therapeutics, Inc. | DE | 333-294645 | Read Filing View |
| 2025-04-01 | SEC Comment Letter | Kyverna Therapeutics, Inc. | DE | 333-286180 | Read Filing View |
| 2024-07-11 | SEC Comment Letter | Kyverna Therapeutics, Inc. | DE | 005-94441 | Read Filing View |
| 2024-01-10 | SEC Comment Letter | Kyverna Therapeutics, Inc. | DE | 377-06910 | Read Filing View |
| 2023-12-28 | SEC Comment Letter | Kyverna Therapeutics, Inc. | DE | 377-06910 | Read Filing View |
| 2023-11-21 | SEC Comment Letter | Kyverna Therapeutics, Inc. | DE | 377-06910 | Read Filing View |
| 2023-11-01 | SEC Comment Letter | Kyverna Therapeutics, Inc. | DE | 377-06910 | Read Filing View |
| Date | Type | Company | Location | File No | Link |
|---|---|---|---|---|---|
| 2026-03-31 | Company Response | Kyverna Therapeutics, Inc. | DE | N/A | Read Filing View |
| 2025-04-11 | Company Response | Kyverna Therapeutics, Inc. | DE | N/A | Read Filing View |
| 2024-02-05 | Company Response | Kyverna Therapeutics, Inc. | DE | N/A | Read Filing View |
| 2024-02-05 | Company Response | Kyverna Therapeutics, Inc. | DE | N/A | Read Filing View |
| 2024-01-25 | Company Response | Kyverna Therapeutics, Inc. | DE | N/A | Read Filing View |
| 2024-01-16 | Company Response | Kyverna Therapeutics, Inc. | DE | N/A | Read Filing View |
2026-03-31 - CORRESP - Kyverna Therapeutics, Inc.
CORRESP 1 filename1.htm CORRESP Kyverna Therapeutics, Inc. 5980 Horton St., STE 550 Emeryville, CA 94608 March 31, 2026 VIA EDGAR United States Securities and Exchange Commission Division of Corporation Finance Office of Life Sciences 100 F Street, N.E. Washington, D.C. 20549-0406 Attention: Dan Crawford Re: Kyverna Therapeutics, Inc. Registration Statement on Form S-3 Filed March 26, 2026 File No. 333-294645 Ladies and Gentlemen: Pursuant to Rule 461 under the Securities Act of 1933, as amended, Kyverna Therapeutics, Inc. (the “ Company ”) hereby respectfully requests that the effectiveness of the Registration Statement on Form S-3 (File No. 333-294645) of the Company, filed with the Securities and Exchange Commission on March 26, 2026 (the “ Registration Statement ”), be accelerated so that the Registration Statement shall become effective at 4:30 p.m., Eastern Time, on April 2, 2026, or as soon as possible thereafter. The Company hereby confirms that it is aware of its responsibilities under the Securities Act of 1933, as amended, and the Securities Exchange Act of 1934, as amended, as they relate to the proposed offering of the securities specified in the Registration Statement. It would be appreciated if, promptly after the Registration Statement has become effective, you would so inform our outside counsel, Samantha H. Eldredge of Paul Hastings LLP, by telephone at (650) 320-1838 or by email at samanthaeldredge@paulhastings.com. The Company hereby authorizes Ms. Eldredge to orally modify or withdraw this request for acceleration. Sincerely, KYVERNA THERAPEUTICS, INC. By: /s/ Marc Grasso Name: Marc Grasso Title: Chief Financial Officer cc: Samantha H. Eldredge, Esq. (Paul Hastings LLP)
2026-03-30 - UPLOAD - Kyverna Therapeutics, Inc. File: 333-294645
<DOCUMENT> <TYPE>TEXT-EXTRACT <SEQUENCE>2 <FILENAME>filename2.txt <TEXT> March 30, 2026 Warner Biddle Chief Executive Officer Kyverna Therapeutics, Inc. 5980 Horton St., STE 550 Emeryville, CA 94608 Re: Kyverna Therapeutics, Inc. Registration Statement on Form S-3 Filed March 26, 2026 File No. 333-294645 Dear Warner Biddle: This is to advise you that we have not reviewed and will not review your registration statement. Please refer to Rules 460 and 461 regarding requests for acceleration. We remind you that the company and its management are responsible for the accuracy and adequacy of their disclosures, notwithstanding any review, comments, action or absence of action by the staff. Please contact Daniel Crawford at 202-551-7767 with any questions. Sincerely, Division of Corporation Finance Office of Life Sciences cc: Samantha Eldredge, Esq. </TEXT> </DOCUMENT>
2025-04-11 - CORRESP - Kyverna Therapeutics, Inc.
CORRESP 1 filename1.htm CORRESP Kyverna Therapeutics, Inc. 5980 Horton St., STE 550 Emeryville, CA 94608 April 11, 2025 VIA EDGAR United States Securities and Exchange Commission Division of Corporation Finance Office of Life Sciences 100 F Street, N.E. Washington, D.C. 20549-0406 Attention: Lauren Hamill Re: Kyverna Therapeutics, Inc. Registration Statement on Form S-3 Filed March 27, 2025 File No. 333-286180 Ladies and Gentlemen: Pursuant to Rule 461 under the Securities Act of 1933, as amended, Kyverna Therapeutics, Inc. (the “ Company ”) hereby respectfully requests that the effectiveness of the Registration Statement on Form S-3 (File No. 333-286180) of the Company, filed with the Securities and Exchange Commission on March 27, 2025 (the “ Registration Statement ”), be accelerated so that the Registration Statement shall become effective at 4:30 p.m., Eastern Time, on April 15, 2025 or as soon as possible thereafter. The Company hereby confirms that it is aware of its responsibilities under the Securities Act of 1933, as amended, and the Securities Exchange Act of 1934, as amended, as they relate to the proposed offering of the securities specified in the Registration Statement. It would be appreciated if, promptly after the Registration Statement has become effective, you would so inform our outside counsel, Samantha H. Eldredge of Paul Hastings LLP, by telephone at (650) 320-1838 or by email at samanthaeldredge@paulhastings.com. The Company hereby authorizes Ms. Eldredge to orally modify or withdraw this request for acceleration. Sincerely, KYVERNA THERAPEUTICS, INC. By: /s/ Ryan Jones Name: Ryan Jones Title: Chief Financial Officer cc: Samantha H. Eldredge, Esq. (Paul Hastings LLP)
2025-04-01 - UPLOAD - Kyverna Therapeutics, Inc. File: 333-286180
<DOCUMENT> <TYPE>TEXT-EXTRACT <SEQUENCE>2 <FILENAME>filename2.txt <TEXT> April 1, 2025 Warner Biddle Chief Executive Officer Kyverna Therapeutics, Inc. 5980 Horton St., STE 550 Emeryville, CA 94608 Re: Kyverna Therapeutics, Inc. Registration Statement on Form S-3 Filed March 27, 2025 File No. 333-286180 Dear Warner Biddle: This is to advise you that we have not reviewed and will not review your registration statement. Please refer to Rules 460 and 461 regarding requests for acceleration. We remind you that the company and its management are responsible for the accuracy and adequacy of their disclosures, notwithstanding any review, comments, action or absence of action by the staff. Please contact Lauren Hamill at 303-844-1008 with any questions. Sincerely, Division of Corporation Finance Office of Life Sciences cc: Samantha Eldredge </TEXT> </DOCUMENT>
2024-07-11 - UPLOAD - Kyverna Therapeutics, Inc. File: 005-94441
July 11, 2024
Jean-Philippe Kouakou-Zebouah
Chief Financial Officer
Vida Ventures, LLC
40 Broad Street, Suite 201
Boston, MA 02109
Re:Vida Ventures, LLC
Kyverna Therapeutics, Inc.
Schedule 13D Filed By Vida Ventures, LLC et al.
Filed May 3, 2024
File No. 005-94441
Dear Jean-Philippe Kouakou-Zebouah:
We have reviewed the above-captioned filing and have the following comment.
Please respond to this letter by amending the filing or by providing the requested
information. If you do not believe our comment applies to your facts and circumstances or that an
amendment is appropriate, please advise us why in a response letter.
After reviewing any amendment to the filing and any information provided in response to
this comment, we may have additional comments.
Schedule 13D Filed May 3, 2024
General
1.We note the date of the event reported as requiring the filing of the Statement was
February 12, 2024. Rule 13d-1(a) of Regulation 13D-G requires the filing of a Schedule
13D within five business days after the date beneficial ownership of more than five
percent of a class of equity securities specified in Rule 13d-1(i)(1) was acquired. Based on
the February 12, 2024 event date, the Schedule 13D submitted on May 3, 2024 was not
timely filed. Please advise us why the Schedule 13D was not filed within the required five
business days after the date of the acquisition.
July 11, 2024
Page 2
We remind you that the filing persons are responsible for the accuracy and adequacy of
their disclosures, notwithstanding any review, comments, action or absence of action by the staff.
Please direct any questions to Shane Callaghan at 202-551-6977 or Nicholas Panos at
202-551-3266.
Sincerely,
Division of Corporation Finance
Office of Mergers & Acquisitions
2024-02-05 - CORRESP - Kyverna Therapeutics, Inc.
CORRESP 1 filename1.htm CORRESP Kyverna Therapeutics, Inc. 5980 Horton St., STE 550 Emeryville, CA 94608 February 5, 2024 VIA EDGAR United States Securities and Exchange Commission Division of Corporation Finance Office of Life Sciences 100 F Street, N.E. Washington, D.C. 20549-0406 Attn: Jenn Do Vanessa Robertson Daniel Crawford Tim Buchmiller Re: Kyverna Therapeutics, Inc. Registration Statement on Form S-1, as amended (File No. 333-276523) Request for Acceleration of Effective Date Ladies and Gentlemen: Pursuant to Rule 461 under the Securities Act of 1933, as amended, Kyverna Therapeutics, Inc. (the “Company”) hereby respectfully requests that the effectiveness of the Registration Statement on Form S-1 (File No. 333-276523) of the Company, filed with the Securities and Exchange Commission (the “Commission”) on January 16, 2024, as amended (the “Registration Statement”), be accelerated so that such Registration Statement shall become effective at 4:00 p.m., Eastern Time, on February 7, 2024 or as soon as possible thereafter. It would be appreciated if, promptly after the Registration Statement has become effective, you would so inform our outside counsel, Jeffrey T. Hartlin of Paul Hastings LLP, by telephone at (650) 320-1804 or by email at jeffhartlin@paulhastings.com, and Samantha H. Eldredge of Paul Hastings LLP, by telephone at (650) 320-1838 or by email at samanthaeldredge@paulhastings.com. The Company hereby authorizes Mr. Hartlin or Ms. Eldredge of Paul Hastings LLP to orally modify or withdraw this request for acceleration. Sincerely, KYVERNA THERAPEUTICS, INC. By: /s/ Peter Maag, Ph.D. Name: Peter Maag, Ph.D. Title: Chief Executive Officer cc: Jeffrey T. Hartlin, Esq. (Paul Hastings LLP) Samantha H. Eldredge, Esq. (Paul Hastings LLP)
2024-02-05 - CORRESP - Kyverna Therapeutics, Inc.
CORRESP 1 filename1.htm CORRESP J.P. Morgan Securities LLC 383 Madison Avenue New York, New York 10179 Morgan Stanley & Co. LLC 1585 Broadway New York, New York 10036 Leerink Partners LLC 1301 Avenue of the Americas, 12th Floor New York, New York 10019 February 5, 2024 VIA EDGAR U.S. Securities and Exchange Commission Division of Corporation Finance Office of Life Sciences 100 F Street, N.E. Washington, D.C. 20549-3720 Attention: Jenn Do, Vanessa Robertson, Daniel Crawford and Tim Buchmiller Re: Kyverna Therapeutics, Inc. Registration Statement on Form S-1, as amended File No. 333-276523 Request for Acceleration of Effective Date Ladies and Gentlemen: In accordance with Rule 461 under the Securities Act of 1933, as amended (the “Act”), we, as representatives of the several underwriters, hereby join in the request of Kyverna Therapeutics, Inc. (the “Company”) for acceleration of the effective date of the above-referenced Registration Statement on Form S-1 so that it becomes effective as of 4:00 p.m. Eastern time on February 7, 2024, or as soon thereafter as practicable, or at such other time as the Company or its outside counsel, Paul Hastings LLP, orally request that such Registration Statement be declared effective. Pursuant to Rule 460 under the Act, we, as representatives of the several underwriters, wish to advise you that there will be distributed to each underwriter or dealer, who is reasonably anticipated to participate in the distribution of the security, as many copies of the proposed form of preliminary prospectus as appears to be reasonable to secure adequate distribution of the preliminary prospectus. We, the undersigned, as representatives of the several underwriters, have complied and will comply, and we have been informed by the participating underwriters that they have complied and will comply, with the requirements of Rule 15c2-8 under the Securities Exchange Act of 1934, as amended. [Remainder of Page Intentionally Left Blank; Signature Page Follows] Very truly yours, J.P. MORGAN SECURITIES LLC MORGAN STANLEY & CO. LLC LEERINK PARTNERS LLC For themselves and on behalf of the several Underwriters listed in Schedule 1 of the Underwriting Agreement J.P. MORGAN SECURITIES LLC By: /s/ Benjamin Burdett Name: Benjamin Burdett Title: Managing Director MORGAN STANLEY & CO. LLC By: /s/ Chirag D. Surti Name: Chirag D. Surti Title: Executive Director LEERINK PARTNERS LLC By: /s/ Murphy Gallagher Name: Murphy Gallagher Title: Senior Managing Director [Signature Page to Underwriters’ Acceleration Request]
2024-01-25 - CORRESP - Kyverna Therapeutics, Inc.
CORRESP 1 filename1.htm CORRESP Submitted pursuant to a Request for Confidential Treatment Pursuant to 17 C.F.R. 200.83 January 25, 2024 FOIA CONFIDENTIAL TREATMENT REQUEST The entity requesting confidential treatment is Kyverna Therapeutics, Inc. 5980 Horton St., STE 550 Emeryville, CA 94608 Telephone: (510) 925-2492 CERTAIN PORTIONS OF THIS LETTER HAVE BEEN OMITTED FROM THE VERSION FILED VIA EDGAR. CONFIDENTIAL TREATMENT HAS BEEN REQUESTED WITH RESPECT TO THE OMITTED PORTIONS. INFORMATION THAT WAS OMITTED IN THE EDGAR VERSION HAS BEEN NOTED IN THIS LETTER WITH A PLACEHOLDER IDENTIFIED BY THE MARK “[***].” VIA EDGAR AND SECURE FILE TRANSFER United States Securities and Exchange Commission Division of Corporation Finance Office of Life Sciences 100 F Street, N.E. Washington, D.C. 20549 Attention: Jenn Do, Vanessa Robertson, Daniel Crawford and Tim Buchmiller RE: Kyverna Therapeutics, Inc. Registration Statement on Form S-1 File No. 333-276523 CIK No. 0001994702 Rule 83 Confidential Treatment Request by Kyverna Therapeutics, Inc. Dear Ladies and Gentlemen: On behalf of Kyverna Therapeutics, Inc. (the “Company”), in response to comments from the staff (the “Staff”) of the Securities and Exchange Commission (the “Commission”) received by letter dated December 28, 2023 (the “Comment Letter”) relating to the Company’s Registration Statement on Form S-1, originally confidentially submitted to the Commission on October 5, 2023, and subsequently publicly filed by the Company with the Commission on January 16, 2024 (File No. 333-276523) (the “Registration Statement”), we submit this supplemental letter to address Comment 4 of the Comment Letter. [*] Certain confidential information in this letter, marked by brackets, has been omitted and filed separately with the SEC pursuant to 17 C.F.R. §200.83. January 25, 2024 Page 2 Because of the commercially sensitive nature of information contained herein, this submission is accompanied by the Company’s request for confidential treatment for selected portions of this letter. The Company has concurrently filed a separate letter with the Office of Freedom of Information and Privacy Act Operations in connection with the confidential treatment request, pursuant to Rule 83 of the Commission’s Rules on Information and Requests, 17 C.F.R. § 200.83. For the Staff’s reference, we have enclosed a copy of the Company’s letter to the Office of Freedom of Information and Privacy Act Operations. We confirm on behalf of the Company that, prior to circulating copies of the preliminary prospectus in connection with the offering, the Company will file a pre-effective amendment to the Registration Statement that will include all information other than information that may be excluded in reliance upon Rule 430A of Regulation C, and the actual price range to be included in such amendment, which will comply with the Staff’s interpretation regarding the parameters of a bona fide price range. The Company expects to reflect the Stock Split (as defined below) in a pre-effective amendment to the Registration Statement that includes the actual price range; however, all dollar amounts and per share amounts in this letter are pre-Stock Split, and therefore, consistent with the Registration Statement. The Company respectfully requests that the bracketed information contained in this letter be treated as confidential information pursuant to Rule 83 promulgated by the Commission, 17 C.F.R. §200.83, and that the Commission provide timely notice to Samantha Eldredge at (650) 320-1838 before it permits any disclosure of the bracketed information in this letter. Preliminary IPO Price Range The Company advises the Staff that it estimates a preliminary price range of approximately $[***] to $[***] per share (the “Preliminary Price Range”) for its initial public offering (“IPO”), before giving effect to a reverse stock split that the Company plans to implement prior to effectiveness of the Registration Statement (the “Stock Split”) resulting in a midpoint of the Preliminary Price Range of $[***] per share (the “Midpoint Price”). The actual price range to be included in a subsequent amendment to the Registration Statement (which will comply with the Staff’s interpretation regarding the parameters of a bona fide price range) has not yet been determined and remains subject to adjustment based on factors outside of the Company’s control. However, the Company believes that the foregoing Preliminary Price Range will not be subject to significant change. [*] Certain confidential information in this letter, marked by brackets, has been omitted and filed separately with the SEC pursuant to 17 C.F.R. §200.83. January 25, 2024 Page 3 Determining the Fair Value of Common Stock Prior to the IPO As there has been no public market for the Company’s common stock (“Common Stock”) prior to the IPO, the estimated fair value of the Common Stock underlying the Company’s stock option awards has been determined by the Company’s board of directors (the “Board”) as of each option grant date with input from management, considering the most recently available third-party valuations of Common Stock and the Board’s assessment of additional objective and subjective factors that it believed were relevant and which may have changed from the date of the most recent valuation through the date of the grant. These third-party valuations were performed in accordance with the guidance outlined in the American Institute of Certified Public Accountants’ Accounting and Valuation Guide, Valuation of Privately-Held-Company Equity Securities Issued as Compensation (the “Practice Aid”). The Company’s most recent third-party valuations of the estimated fair value of its Common Stock were as follows: Date of Third-Party Valuation Date of Board Approval Estimated Fair Market Value per share of Common Stock January 31, 2022 February 28, 2022 $ [ ***] October 31, 2022 November 22, 2022 $ [ ***] June 30, 2023 July 13, 2023 $ [ ***] September 25, 2023 October 31, 2023 $ [ ***] December 18, 2023 December 29, 2023 $ [ ***] The following table summarizes by grant date the number of stock options granted by the Company since January 1, 2022, the exercise price per share of Common Stock underlying the stock options and the estimated fair value of a share of Common Stock on each grant date: Grant Date Number of Shares Underlying Stock Options Exercise Price Per Share of Common Stock Estimated Fair Value Per Share of Common Stock February 28, 2022 [ ***] $ [ ***] $ [ ***] March 23, 2022 [ ***] [ ***] [ ***] March 27, 2022 [ ***] [ ***] [ ***] May 19, 2022 [ ***] [ ***] [ ***] July 28, 2022 [ ***] [ ***] [ ***] September 21, 2022 [ ***] [ ***] [ ***] November 22, 2022 [ ***] [ ***] [ ***] January 26, 2023 [ ***] [ ***] [ ***] February 3, 2023 [ ***] [ ***] [ ***] March 16, 2023 [ ***] [ ***] [ ***] [*] Certain confidential information in this letter, marked by brackets, has been omitted and filed separately with the SEC pursuant to 17 C.F.R. §200.83. January 25, 2024 Page 4 July 13, 2023 [***] [***] [***] October 4, 2023(*) [***] [***] [***] November 6, 2023(*) [***] [***] [***] December 29, 2023 [***] [***] [***] * The fair value of the Common Stock at the date of the respective grant was determined using a linear interpolation between two valuation dates for financial reporting purposes, as further described below. The Company determined the hybrid method was the most appropriate method for determining the fair value of the Common Stock. The hybrid method is a probability-weighted expected return method, or PWERM, where the equity value in one or more scenarios is calculated using an option pricing model, or OPM. The Company determined this was the most appropriate method for determining the fair value of the Common Stock based on the Company’s stage of development and other relevant factors. The PWERM is a scenario-based analysis that estimates the value per share of the Common Stock based on the probability-weighted present value of expected future equity values for the Common Stock under various future liquidity event scenarios, considering the rights and preferences of each class of shares, and discounted for a lack of marketability, or DLOM. Under the hybrid method, an OPM was used to determine the fair value of the Common Stock in certain of the PWERM scenarios (capturing situations where the development path and future liquidity events were difficult to forecast), and potential exit events were explicitly modeled in the other PWERM scenarios. A DLOM was applied to the value derived under each scenario to account for a lack of access to an active public market to estimate the fair value of the Common Stock. In addition to considering the results of independent third-party valuations, the Board considered various objective and subjective factors to determine the fair value of the Common Stock as of each grant date, including: • the prices at which the Company sold shares of its preferred stock and the superior rights, preferences, and privileges of its preferred stock relative to those of the Common Stock at the time of each grant; • the progress of research and development programs, including the status of preclinical studies and clinical trials for the Company’s product candidates; • the stage of development and business strategy, and material risks related to the Company’s business; • external market conditions affecting the biotechnology industry and trends within the biotechnology industry; • the competitive landscape for the Company’s product candidates; [*] Certain confidential information in this letter, marked by brackets, has been omitted and filed separately with the SEC pursuant to 17 C.F.R. §200.83. January 25, 2024 Page 5 • the Company’s financial position, including cash on hand, and its historical and forecasted performance and operating results; • the lack of an active public market for the Common Stock and the Company’s preferred stock; • the likelihood of achieving a liquidity event, such as an IPO or a sale of the Company, given prevailing market conditions; and • general economic conditions. The assumptions underlying these valuations represented management’s best estimate, which involved inherent uncertainties and the application of management’s judgment. As a result, if the Company had used significantly different assumptions or estimates, the fair value of the Common Stock and the stock-based compensation expense could be materially different. Once a public trading market for the Common Stock has been established in connection with the completion of the IPO, it will no longer be necessary for the Board to estimate the fair value of the Common Stock in connection with accounting for granted stock options and other equity awards the Company may grant, as the fair value of the Common Stock will be based on the quoted market price of the Common Stock. January 2022 Valuation The Company, with the assistance of a third-party valuation firm, performed a valuation of the Common Stock as of January 31, 2022. The Company utilized the Hybrid OPM model to estimate the fair value of the Common Stock, considering two scenarios: June 2023 IPO scenario with [***]% probability, and non-IPO scenario (the “Remain Private scenario”) with [***]% probability. The probabilities were based on management’s estimates of the likelihood of each outcome as of the valuation date. Management estimated that the equity value for the June 2023 IPO scenario would be $[***] million. This value was based on the Series B preferred stock financing post-money valuation adjusted for a step-up of [***]x and the future financing of $[***] million adjusted for a step-up of [***]x. The Company initially issued shares of its Series B preferred stock in three closings that occurred in November 2021, December 2021 and January 2022, to existing and new investors for aggregate gross cash proceeds of $85.0 million at a purchase price of $1.8719 per share, of which $12.0 million was sold to new investors in January 2022. The Company’s management also considered that it would need an additional crossover financing to bridge to the estimated June 2023 IPO, and as such, the additional financing was included in the Company’s equity value. The step-up multiples were estimated based on comparable companies’ financing transactions prior to their IPOs and expected market conditions. The selected exit value of $[***] million fell within the first quartile and the median of the pre-money IPO value of biopharma IPO transactions with the lead program in Phase I of development at the time of the IPO, which was consistent with management’s expectations of the Company’s stage of clinical development at the time of IPO. Then, the calculated fair value of the Common Stock was discounted using a [***]% discount rate, which resulted in the fair value of the Common Stock of $[***] per share. The [***]% discount rate represents an enterprise-level weighted-average cost of capital. [*] Certain confidential information in this letter, marked by brackets, has been omitted and filed separately with the SEC pursuant to 17 C.F.R. §200.83. January 25, 2024 Page 6 For the Remain Private scenario, the Company used the OPM backsolve model. The equity value was determined to be approximately $[***] million based on the Company’s recent Series B preferred stock financing. To arrive at the equity value under the Remain Private scenario, the Company’s management used a [***]% risk-free rate, [***]% volatility and [***] years expected term. The expected term was estimated by management as a time to an exit event. The Company estimated volatility using comparable public companies’ volatilities that correspond with the expected term. The fair value of the Common Stock was estimated to be $[***] per share. The Board and the third-party valuation firm also considered the fact that the Company’s stockholders could not freely trade the Common Stock on the public markets. The Company calculated DLOM of [***]% and [***]% for the June 2023 IPO and the Remain Private scenarios, respectively, using the Finnerty and Asian Put models, which was then applied to the fair value of the Common Stock for each scenario. The probabilities-adjusted fair value was estimated as $[***] per share of Common Stock (the “January 2022 Valuation”). February, March, May, July and September 2022 Grants From February through September 2022, the Company granted options to purchase an aggregate of [***] shares of Common Stock with an exercise price of $[***] per share, which was the estimated fair value at each grant date. In determining the fair value of the Common Stock, the Board considered the January 2022 Valuation, the Company’s progress in its research and development activities and overall economic and biotechnology market conditions. The Board determined that there were no significant changes between January and September 2022 that would significantly impact the valuation of the Company and the value of the Common Stock. In December 2021, the Company entered into a license agreement with Intellia Therapeutics, Inc., and was making progress to advance its lead product candidate, KYV-101, through investigational new drug application (“IND”)-enabling studies. Furthermore, market conditions had not improved from January to September 2022, and early-stage biotech valuations were decreasing significantly. October 2022 Valuation The Company, with the assistance of a third-party valuation firm, performed a valuation of the Common Stock as of October 31, 2022. The Company utilized the Hybrid OPM model to estimate the fair value of the Common Stock, considering two scenarios: June 2024 IPO scenario with [***]% proba
2024-01-16 - CORRESP - Kyverna Therapeutics, Inc.
CORRESP 1 filename1.htm CORRESP January 16, 2024 United States Securities and Exchange Commission Division of Corporation Finance Office of Life Sciences 100 F Street, N.E. Washington, D.C. 20549 Attn: Jenn Do Vanessa Robertson Daniel Crawford Tim Buchmiller Re: Kyverna Therapeutics, Inc. Amendment No. 3 to Draft Registration Statement on Form S-1 Submitted January 8, 2024 CIK No. 0001994702 Ladies and Gentlemen: On behalf of our client, Kyverna Therapeutics, Inc., a Delaware corporation (the “Company”), we submit to the staff of the Division of Corporation Finance (the “Staff”) of the United States Securities and Exchange Commission (the “Commission”) the Company’s response to the comments contained in the Staff’s letter, dated January 10, 2024 (the “Comment Letter”), with respect to the above-referenced Amendment No. 3 to Draft Registration Statement on Form S-1 submitted on January 8, 2024. Concurrent herewith, the Company has filed via EDGAR its Registration Statement on Form S-1 (the “Registration Statement”), which reflects the Company’s responses to the comments received from the Staff and certain other updated information. For ease of reference, each comment contained in the Comment Letter is printed below in bold and is followed by the Company’s response. All page references in the responses set forth below refer to the page numbers in the Registration Statement. All capitalized terms used but not defined in this response letter have the meanings ascribed to such terms in the Registration Statement. Amendment No. 3 to Draft Registration Statement on Form S-1 submitted January 8, 2024 Prospectus Summary Our pipeline and programs, page 3 1. We note your response to prior comment 2 and reissue in part. Please revise your pipeline tables here and elsewhere to enlarge the footnotes so they are legible. Response: The Company respectfully acknowledges the Staff’s comment and has revised the disclosure on pages 3, 120 and 127 of the Registration Statement in response to the Staff’s comment. Principal Stockholders, page 202 2. Please revise footnote 1 to include disclosure of the natural person or persons who have voting and investment control of the shares held by the entity listed in the table. Response: The Company respectfully acknowledges the Staff’s comment and advises the Staff that, with respect to the securities held by Bain Capital Life Sciences Opportunities III, LP, no natural person is the beneficial owner of such securities for purposes of Section 13(d) of the Securities Exchange Act of 1934, as amended, and Rule 13d-3 thereunder. As described in footnote 1 to the Principal Stockholders table on page 205 of the Registration Statement, Bain Capital Life Sciences Investors, LLC is the manager of Bain Capital Life Sciences III General Partner, LLC, which is the general partner of Bain Capital Life Sciences Fund III, L.P., which is the sole member of Bain Capital Life Sciences Opportunities III GP, LLC, which is the general partner of Bain Capital Life Sciences Opportunities III, LP. The Company has revised the disclosure in footnote 1 to the beneficial ownership table on page 205 of the Registration Statement to state that voting and investment decisions with respect to securities held by Bain Capital Life Sciences Opportunities III, L.P. are made by the partners of Bain Capital Life Sciences Investors, LLC, of whom there are three or more and none of whom individually has the power to direct such decisions. Please do not hesitate to contact Jeffrey Hartlin at (650) 320-1804 or Samantha Eldredge at (650) 320-1838 if you require additional information with respect to any of the foregoing. Thank you. Sincerely, Paul Hastings LLP cc: Peter Maag, Ph.D. Kyverna Therapeutics, Inc. Jeffrey Hartlin, Esq. Paul Hastings LLP Samantha Eldredge, Esq. Paul Hastings LLP 2
2024-01-10 - UPLOAD - Kyverna Therapeutics, Inc. File: 377-06910
United States securities and exchange commission logo
January 10, 2024
Peter Maag, Ph.D.
Chief Executive Officer
Kyverna Therapeutics, Inc.
5980 Horton St., STE 550
Emeryville, CA 94608
Re:Kyverna Therapeutics, Inc.
Amendment No. 3 to Draft Registration Statement on Form S-1
Submitted January 8, 2024
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. 3 to Draft Registration Statement on Form S-1 submitted January 8, 2024
Prospectus Summary
Our pipeline and programs, page 3
1.We note your response to prior comment 2 and reissue in part. Please revise your pipeline
tables here and elsewhere to enlarge the footnotes so they are legible.
Principal Stockholders, page 202
2.Please revise footnote 1 to include disclosure of the natural person or persons who have
voting and investment control of the shares held by the entity listed in the table.
FirstName LastNamePeter Maag, Ph.D.
Comapany NameKyverna Therapeutics, Inc.
January 10, 2024 Page 2
FirstName LastName
Peter Maag, Ph.D.
Kyverna Therapeutics, Inc.
January 10, 2024
Page 2
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.
2023-12-28 - UPLOAD - Kyverna Therapeutics, Inc. File: 377-06910
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.
2023-11-21 - UPLOAD - Kyverna Therapeutics, Inc. File: 377-06910
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.
FirstName LastNamePeter Maag, Ph.D.
Comapany NameKyverna Therapeutics, Inc.
November 21, 2023 Page 2
FirstName LastName
Peter Maag, Ph.D.
Kyverna Therapeutics, Inc.
November 21, 2023
Page 2
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.
FirstName LastNamePeter Maag, Ph.D.
Comapany NameKyverna Therapeutics, Inc.
November 21, 2023 Page 3
FirstName LastName
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,
Division of Corporation Finance
Office of Life Sciences
cc: Jeffrey T. Hartlin, Esq.
2023-11-01 - UPLOAD - Kyverna Therapeutics, Inc. File: 377-06910
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.