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Artiva Biotherapeutics, Inc.
Response Received
1 company response(s)
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Artiva Biotherapeutics, Inc.
Response Received
4 company response(s)
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SEC wrote to company
2024-06-21
Artiva Biotherapeutics, Inc.
Summary
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Company responded
2024-06-28
Artiva Biotherapeutics, Inc.
References: June 21, 2024
Summary
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Company responded
2024-07-05
Artiva Biotherapeutics, Inc.
References: May 30, 2024
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Company responded
2024-07-16
Artiva Biotherapeutics, Inc.
Summary
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Company responded
2024-07-16
Artiva Biotherapeutics, Inc.
Summary
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Artiva Biotherapeutics, Inc.
Awaiting Response
0 company response(s)
High
SEC wrote to company
2024-05-30
Artiva Biotherapeutics, Inc.
Summary
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Summary
| Date | Type | Company | Location | File No | Link |
|---|---|---|---|---|---|
| 2025-08-13 | Company Response | Artiva Biotherapeutics, Inc. | DE | N/A | Read Filing View |
| 2025-08-11 | SEC Comment Letter | Artiva Biotherapeutics, Inc. | DE | 333-289325 | Read Filing View |
| 2024-07-16 | Company Response | Artiva Biotherapeutics, Inc. | DE | N/A | Read Filing View |
| 2024-07-16 | Company Response | Artiva Biotherapeutics, Inc. | DE | N/A | Read Filing View |
| 2024-07-05 | Company Response | Artiva Biotherapeutics, Inc. | DE | N/A | Read Filing View |
| 2024-06-28 | Company Response | Artiva Biotherapeutics, Inc. | DE | N/A | Read Filing View |
| 2024-06-21 | SEC Comment Letter | Artiva Biotherapeutics, Inc. | DE | 377-07214 | Read Filing View |
| 2024-05-30 | SEC Comment Letter | Artiva Biotherapeutics, Inc. | DE | 377-07214 | Read Filing View |
| Date | Type | Company | Location | File No | Link |
|---|---|---|---|---|---|
| 2025-08-11 | SEC Comment Letter | Artiva Biotherapeutics, Inc. | DE | 333-289325 | Read Filing View |
| 2024-06-21 | SEC Comment Letter | Artiva Biotherapeutics, Inc. | DE | 377-07214 | Read Filing View |
| 2024-05-30 | SEC Comment Letter | Artiva Biotherapeutics, Inc. | DE | 377-07214 | Read Filing View |
| Date | Type | Company | Location | File No | Link |
|---|---|---|---|---|---|
| 2025-08-13 | Company Response | Artiva Biotherapeutics, Inc. | DE | N/A | Read Filing View |
| 2024-07-16 | Company Response | Artiva Biotherapeutics, Inc. | DE | N/A | Read Filing View |
| 2024-07-16 | Company Response | Artiva Biotherapeutics, Inc. | DE | N/A | Read Filing View |
| 2024-07-05 | Company Response | Artiva Biotherapeutics, Inc. | DE | N/A | Read Filing View |
| 2024-06-28 | Company Response | Artiva Biotherapeutics, Inc. | DE | N/A | Read Filing View |
2025-08-13 - CORRESP - Artiva Biotherapeutics, Inc.
CORRESP 1 filename1.htm CORRESP A RTIVA B IOTHERAPEUTICS , I NC . 5505 Morehouse Drive, Suite 100 San Diego CA 92121 August 13, 2025 VIA EDGAR U.S. Securities and Exchange Commission Division of Corporation Finance 100 F Street, N.E. Washington, D.C. 20549 Attn: Tim Buchmiller Re: Artiva Biotherapeutics, Inc. Registration Statement on Form S-3 (File No. 333-289325) Filed: August 6, 2025 Request for Acceleration of Effective Date Dear Mr. Buchmiller, In accordance with Rule 461 under the Securities Act of 1933, as amended, the undersigned registrant (the “ Registrant ”) hereby requests that the Securities and Exchange Commission (the “ Commission ”) take appropriate action to cause the above-referenced Registration Statement on Form S-3 (File No. 333-289325) (the “ Registration Statement ”) to become effective on August 15, 2025, at 4:00 p.m. Eastern Time, or as soon thereafter as is practicable, or at such other time as the Registrant or its legal counsel, Cooley LLP, may request by telephone to the staff of the Commission. The Registrant hereby authorizes each of Carlos Ramirez and Christine S. Kim of Cooley LLP to make such a request on its behalf. Once the Registration Statement has been declared effective, please confirm that event with Carlos Ramirez of Cooley LLP at (858) 550-6157 or cramirez@cooley.com, or in his absence, Christine S. Kim at (858) 550-6110 or cskim@cooley.com. Very truly yours, Artiva Biotherapeutics, Inc. By: /s/ Fred Aslan, M.D. Fred Aslan, M.D. President and Chief Executive Officer cc: Neha Krishnamohan, Artiva Biotherapeutics, Inc. Jennifer Bush, Artiva Biotherapeutics, Inc. Andrew Cronauer, Artiva Biotherapeutics, Inc. Carlos Ramirez, Cooley LLP Christine S. Kim, Cooley LLP
2025-08-11 - UPLOAD - Artiva Biotherapeutics, Inc. File: 333-289325
<DOCUMENT> <TYPE>TEXT-EXTRACT <SEQUENCE>2 <FILENAME>filename2.txt <TEXT> August 11, 2025 Fred Aslan, M.D. President and Chief Executive Officer Artiva Biotherapeutics, Inc. 5505 Morehouse Drive, Suite 100 San Diego, CA 92121 Re: Artiva Biotherapeutics, Inc. Registration Statement on Form S-3 Filed August 6, 2025 File No. 333-289325 Dear Fred Aslan M.D.: 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 Tim Buchmiller at 202-551-3635 with any questions. Sincerely, Division of Corporation Finance Office of Life Sciences cc: Carlos Ramirez, Esq. </TEXT> </DOCUMENT>
2024-07-16 - CORRESP - Artiva Biotherapeutics, Inc.
CORRESP 1 filename1.htm CORRESP July 16, 2024 Jefferies LLC 520 Madison Avenue New York, New York 10022 TD Securities (USA) LLC 1 Vanderbilt Avenue New York, New York 10017 Cantor Fitzgerald & Co. 110 E. 59th St., 6th Floor New York, New York 10020 VIA EDGAR U.S. Securities and Exchange Commission Division of Corporation Finance 100 F Street, N.E. Washington, D.C. 20549 Attn: Sasha Parikh Lynn Dicker Lauren Hamill Jason Drory Re: Artiva Biotherapeutics, Inc. Registration Statement on Form S-1 (File No. 333-280568) Acceleration Request Requested Date: July 18, 2024 Requested Time: 4:00 P.M. Eastern Time Ladies and Gentlemen: In accordance with Rule 461 of the Securities Act of 1933, as amended (the “Securities Act”), we, as representatives of the several underwriters (the “Representatives”), hereby join in the request of Artiva Biotherapeutics, Inc., a Delaware corporation (the “Registrant”), that the effectiveness of the above-captioned Registration Statement, as amended, be accelerated to 4:00 p.m. Eastern Time on July 18, 2024, or as soon thereafter as practicable, or at such other time as the Registrant or its outside counsel, Cooley LLP, request by telephone that such Registration Statement be declared effective. Pursuant to Rule 460 under the Securities Act, please be advised that we will take reasonable steps to secure adequate distribution of the preliminary prospectus, to underwriters, dealers, institutions and others, prior to the requested effective time of the Registration Statement. We, the undersigned Representatives, have and will, and we have been informed by the participating underwriters that they have and will, comply with the requirements of Rule 15c2-8 under the Securities Exchange Act of 1934, as amended, in connection with the proposed offering. [Remainder of page intentionally left blank] Very truly yours, Acting severally on behalf of themselves and the several underwriters JEFFERIES LLC TD SECURITIES (USA) LLC CANTOR FITZGERALD & CO. JEFFERIES LLC By: /s/ Matthew Kim Name: Matthew Kim Title: Managing Director, Joint Head of US Biotech TD SECURITIES (USA) LLC By: /s/ Tanya Joseph Name: Tanya Joseph Title: Managing Director CANTOR FITZGERALD & CO. By: /s/ Jason Fenton Name: Jason Fenton Title: Global Co-Head of ECM [Signature Page to Underwriters’ Acceleration Request Letter]
2024-07-16 - CORRESP - Artiva Biotherapeutics, Inc.
CORRESP 1 filename1.htm CORRESP Artiva Biotherapeutics, Inc. 5505 Morehouse Drive, Suite 100 San Diego, CA 92121 July 16, 2024 VIA EDGAR Office of Life Sciences Division of Corporation Finance U.S. Securities and Exchange Commission 100 F Street, N.E. Washington, D.C. 20549 Attn: Sasha Parikh, Lynn Dicker, Lauren Hamill and Jason Drory Re: Artiva Biotherapeutics, Inc. Registration Statement on Form S-1, as amended (File No. 333-280568) Request for Acceleration of Effective Date Ladies and Gentlemen: Pursuant to Rule 461 of the General Rules and Regulations under the Securities Act of 1933, as amended, Artiva Biotherapeutics, Inc. (the “Company”) hereby requests that the U.S. Securities and Exchange Commission (the “Commission”) accelerate the effective date of the above-referenced Registration Statement on Form S-1 (as amended to date, the “Registration Statement”) and declare the Registration Statement effective as of 4:00 p.m. Eastern time, on July 18, 2024, or as soon thereafter as possible, or at such other time as its legal counsel, Cooley LLP, may request by telephone to the staff of the Commission. Once the Registration Statement has been declared effective, please orally confirm that event with Carlos Ramirez of Cooley LLP at (858) 550-6157 or, in his absence, Charles S. Kim of Cooley LLP at (858) 550-6049. Under separate cover, you will receive today a letter from the managing underwriters of the proposed offering joining in the Company’s request for acceleration of the effectiveness of the Registration Statement. Very truly yours, Artiva Biotherapeutics, Inc. /s/ Fred Aslan, M.D. By: Fred Aslan, M.D. Title: President and Chief Executive Officer cc: Fred Aslan, M.D., President and Chief Executive Officer, Artiva Biotherapeutics, Inc. Jennifer Bush, Chief Operating Officer, Artiva Biotherapeutics, Inc. Neha Krishnamohan, Chief Financial Officer, Artiva Biotherapeutics, Inc. Carlos Ramirez, Cooley LLP Charles S. Kim, Cooley LLP Matthew T. Bush, Latham & Watkins LLP Cheston J. Larson, Latham & Watkins LLP Anthony Gostanian, Latham & Watkins LLP
2024-07-05 - CORRESP - Artiva Biotherapeutics, Inc.
CORRESP 1 filename1.htm CORRESP BY EDGAR Carlos Ramirez T: (858) 550-6157 cramirez@cooley.com *FOIA Confidential Treatment Request* Confidential Treatment Requested by Artiva Biotherapeutics, Inc. In connection with its Registration Statement on Form S-1 (File No. 333-280568) July 5, 2024 U.S. Securities and Exchange Commission Division of Corporation Finance Office of Life Sciences 100 F Street, N.E. Washington, D.C. 20549 Attention: Sasha Parikh Lynn Dicker Lauren Hamill Jason Drory Re: Artiva Biotherapeutics, Inc. Registration Statement on Form S-1 Filed June 28, 2024 File No. 333-280568 Ladies and Gentlemen: On behalf of Artiva Biotherapeutics, Inc. (the “Company”), we submit this supplemental letter in response to comments from the staff (the “Staff”) of the U.S. Securities and Exchange Commission (the “Commission”) received by letter dated May 30, 2024 (the “Initial Comment Letter”) relating to the Company’s Registration Statement on Form S-1, originally confidentially submitted to the Commission on May 3, 2024, resubmitted to the Commission on June 7, 2024, and filed with the Commission on June 28, 2024 (the “Registration Statement”). This supplemental letter addresses comment 11 of the Initial Comment Letter. Because of the commercially sensitive nature of certain information contained herein, this supplemental letter is accompanied by the Company’s request for confidential treatment for selected portions of this supplemental letter. The Company has filed separate correspondence with the Office of Freedom of Information and Privacy Act Operations in connection with its 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 correspondence to the Office of Freedom of Information and Privacy Act Operations, as well as an unredacted copy of this supplemental letter, marked to show the portions redacted from the version filed via EDGAR and for which the Company is requesting confidential treatment. For the convenience of the Staff, we have recited the prior comment from the Initial Comment Letter in italicized type and have followed the comment with the Company’s response. [***] = Certain confidential information contained in this document, marked by bracketed asterisks, has been omitted and filed separately with the Securities and Exchange Commission pursuant to 17 CFR §200.83. Cooley LLP 10265 Science Center Drive San Diego, CA 92121-1117 t: (858) 550-6000 f: (858) 550-6420 cooley.com U.S. Securities and Exchange Commission July 5, 2024 Page Two 11. 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 IPO and the estimated offering price. This information will help facilitate our review of your accounting for equity issuances including stock compensation and beneficial conversion features. Please discuss with the staff how to submit your response. The Company’s discussion of its accounting for stock-based compensation is primarily contained within the sections of the Registration Statement entitled “Management’s Discussion and Analysis of Financial Condition and Results of Operations—Critical Accounting Policies and Significant Judgments and Estimates—Stock-Based Compensation Expense” and “—Common Stock Valuation” appearing on pages 108 to 110 of the Registration Statement. The Company submits the below additional information to assist the Staff in its review of the Company’s position with respect to its determination of the fair value of the shares of common stock underlying its outstanding equity awards and the reasons for the difference between the recent valuations of the common stock and the estimated offering price for its initial public offering (“IPO”). Preliminary IPO Price Range The Company advises the Staff that it preliminarily estimates a price range of approximately $[***] to $[***] per share (the “Preliminary Price Range”) of the Company’s common stock for its IPO. The Preliminary Price Range does not reflect the impact of a reverse stock split of its common stock (currently anticipated to be at a ratio of 1-for- [***]), which reverse stock split will be effected prior to the filing of and reflected in an amendment to the Registration Statement taking place before the commencement of the road show. On a post-reverse stock split basis, the Preliminary Price Range is estimated to be $[***] to $[***] per share. The Preliminary Price Range does not take into account the current lack of liquidity for the Company’s common stock and assumes a successful IPO, with no weighting attributed to any other outcome for the Company’s business, such as remaining as a privately held company or being sold in a change of control transaction. As is typical in IPOs, the Preliminary Price Range was not derived using a formal determination of fair value, but was determined through discussions among the board of directors of the Company (the “Board”), senior management of the Company and the lead underwriters for its IPO. Among the factors that were considered in estimating the Preliminary Price Range were the following: • the Company’s financial position and prospects; • prospects of the biopharmaceutical industry; • an analysis of the typical valuation ranges seen in recent IPOs for comparable companies in the Company’s industry; • the general conditions of the securities market and the recent market prices of, and the demand for, publicly traded common stock of comparable companies; • feedback from potential investors following “testing the waters” meetings that occurred in May 2024 and June 2024; • input received from Jefferies LLC, TD Securities (USA) LLC and Cantor Fitzgerald & Co., the lead underwriters (the “Representatives”) for the IPO; and • the recent financial performance of IPOs of companies in the industry in which the Company operates. [***] = Certain confidential information contained in this document, marked by bracketed asterisks, has been omitted and filed separately with the Securities and Exchange Commission pursuant to 17 CFR §200.83. Cooley LLP 10265 Science Center Drive San Diego, CA 92121-1117 t: (858) 550-6000 f: (858) 550-6420 cooley.com U.S. Securities and Exchange Commission July 5, 2024 Page Three The Company will include a narrower bona fide price range of the common stock, as adjusted for the reverse stock split, in an amendment to the Registration Statement that will precede the commencement of the Company’s road show. The parameters of the bona fide price range will be subject to then-current market conditions, continuing discussions with the Representatives, and volatility in the securities markets, including, in particular, the volatility experienced in the market by recent IPO issuers. In any event, the Company confirms to the Staff that the bona fide price range will comply with Item 501(b)(3) of Regulation S-K and CD&I 134.04. Summary of Recent Equity Awards From January 1, 2023 to date, the Company has issued (or repriced) the following stock option awards to its employees, consultants and members of its Board: Grant Date Number of Shares Underlying Equity Awards Exercise Price Per Share Estimated Common Stock Fair Value Per Share on Date of Grant January 5, 2023 201,800 $ 1.14 $ 1.14 March 30, 2023 95,000 $ 1.14 $ 1.14 April 3, 2023 5,125,705 (1) $ 1.14 $ 1.14 May 24, 2023 172,000 $ 1.14 $ 1.14 August 18, 2023 151,500 $ 1.14 $ 1.14 January 24, 2024 663,679 $ 1.18 $ 1.18 March 28, 2024 220,000 $ 1.18 $ 1.18 May 2, 2024 1,421,000 $ 3.07 $ 3.07 (1) Previously granted options to purchase an aggregate of 5,125,705 shares of Common Stock were repriced on April 3, 2023 to provide for an exercise price of $1.14 per share. The Company treated the repricing as a modification of terms of the options outstanding. Please see pages F-25, F-50 and F-51 of the Registration Statement for further information regarding the repricing. Determination of Common Stock Fair Value Prior to IPO As described in the Registration Statement, as there has been no public market for the Company’s common stock to date, the estimated fair value of its common stock historically has been determined by the Board or the Compensation Committee of the Board (references herein to the Board shall include the Compensation Committee), as of the date of each option grant, with input from management, considering the Company’s third-party valuations of its common stock as well as the Board’s assessment of additional objective and subjective factors that the Board believed were relevant and which may have changed from [***] = Certain confidential information contained in this document, marked by bracketed asterisks, has been omitted and filed separately with the Securities and Exchange Commission pursuant to 17 CFR §200.83. Cooley LLP 10265 Science Center Drive San Diego, CA 92121-1117 t: (858) 550-6000 f: (858) 550-6420 cooley.com U.S. Securities and Exchange Commission July 5, 2024 Page Four the date of the most recent third-party valuation through the date of the grant. The third-party valuations of the Company’s common stock that the Board considered in making its determinations were prepared in accordance with 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 Board considered various objective and subjective factors to determine the fair value of the Company’s common stock as of each grant date, including: • valuations of the Company’s common stock performed by independent third-party valuation specialists; • the anticipated capital structure that will directly impact the value of the currently outstanding securities; • the Company’s results of operations and financial position; • the status of the Company’s research and development efforts; • the composition of, and changes to, the Company’s management team and board of directors; • the lack of liquidity of the Company’s common stock as a private company; • the Company’s stage of development and business strategy and the material risks related to the Company’s business and industry; • external market conditions affecting the life sciences and biotechnology industry sectors; • U.S. and global economic conditions; • the likelihood of achieving a liquidity event for the holders of the Company’s common stock, such as an IPO or a sale of the Company, given prevailing market conditions; and • the market value and volatility of comparable companies Independent third-party valuations related to the stock option awards described above were performed as of the following dates: • December 31, 2022; • November 30, 2023; and • April 18, 2024. The third-party valuations of the common stock that the Board considered in making its determinations were prepared in accordance with the Practice Guide, which prescribes several valuation approaches for determining the value of an enterprise, such as the cost, market and income approaches, and various methodologies for allocating the value of an enterprise to its capital structure and specifically its common stock. In accordance with the Practice Aid, the Company considered the following methods for allocating the enterprise value across its classes and series of capital stock to determine the estimated fair value of the common stock at each valuation date. • Option Pricing Method (“OPM”). The OPM estimates the value of the common stock using the various inputs in the Black-Scholes option pricing model. The OPM treats the rights of the holders of common stock as equivalent to that of call options on any value of the enterprise above certain break points of value based upon the liquidation preferences of the holders of the Company’s convertible preferred stock and SAFEs, as well as their rights to participation, and the stock prices of the outstanding options. Thus, the value of the common stock can be determined by estimating the value of its portion of each of these call option rights. Under this method, the common stock has value only if the funds available for distribution to stockholders exceed the value of the liquidation preference at the time of a liquidity event, such as a merger or sale. [***] = Certain confidential information contained in this document, marked by bracketed asterisks, has been omitted and filed separately with the Securities and Exchange Commission pursuant to 17 CFR §200.83. Cooley LLP 10265 Science Center Drive San Diego, CA 92121-1117 t: (858) 550-6000 f: (858) 550-6420 cooley.com U.S. Securities and Exchange Commission July 5, 2024 Page Five • Probability-Weighted Expected Return Method (“PWERM”). The PWERM is a scenario-based analysis that estimates the value per share based on the probability-weighted present value of expected future investment returns, considering each of the possible outcomes available to the Company, as well as the economic and control rights of each share class. • Hybrid Method (“Hybrid Method”). The Hybrid Method is a weighted-average method that combines both OPM and PWERM. Weighting allocations are assigned to the OPM and PWERM methods factoring in possible future liquidity events. To support the Board in determining the estimated fair value of the common stock, the OPM was utilized for the independent third-party valuations of the common stock as of December 31, 2022 (the “December 2022 Valuation”) and November 30, 2023 (the “November 2023 Valuation”), as discussed below. As the Company obtained better visibility into the timing of a potential IPO, but accounting for uncertainty around the Company’s value should an IPO not occur, the valuation methodology changed to the use of a Hybrid Method for the independent third-party valuation of the common stock as of April 18, 2024 (the “April 2024 Valuation”), as discussed below. The OPM and Hybrid Method are commonly used in these situations and such use is consistent with guidance from the Practice Aid. In the Company’s case, the Hybrid Method incorporated two scenarios: (1) an alternative exit (stay-private) scenario where the allocation of total equity value was performed using the OPM, and (2) an IPO scenario where all outstanding shares of the Company’s convertible preferred stock were assumed to be mandatorily converted into shares of common stock. In the IPO scenario, the Company assumed that all outstanding shares of its convertible preferred stock and all the Company’s outstanding simple agreements for future equity (the “SAFEs”) would be converted into shares of common stock. In addition, given the common stock represents a non-marketable equity interest in a private enterprise, an adjustment to the preliminary value estimates had to be made in each of the OPM and Hybrid Method to account for the lack of liquidity that a stockholder experiences. This adjustment is commonly referred to as a discount for lack of marketability (“DLOM”). At each grant date, the Board evaluated any recent events and their potential impact on the estimated fair value per share of the common stock. The Board determined the estimated fair value of the common stock on the date of grant taking into consideration the most recent valuation report as well as other pertinent information available to it at the time of the grant. December 2022 Valuation – January 5, 2023, March 30, 2023, May 24, 2023 and August 18, 2023 Grants and April 3, 2023 Repricing On January 5, 2023, March 30, 2023, May 24, 2023 and August 18, 2023, the
2024-06-28 - CORRESP - Artiva Biotherapeutics, Inc.
CORRESP 1 filename1.htm CORRESP Carlos Ramirez +1 858 550 6157 cramirez@cooley.com By EDGAR June 28, 2024 Office of Life Sciences Division of Corporation Finance U.S. Securities and Exchange Commission 100 F Street, N.E. Washington, D.C. 20549 Attn: Sasha Parikh, Lynn Dicker, Lauren Hamill and Jason Drory Re: Artiva Biotherapeutics, Inc. Amendment No. 1 to Draft Registration Statement on Form S-1 Submitted June 10, 2024 CIK No. 0001817241 Ladies and Gentlemen: On behalf of Artiva Biotherapeutics, Inc. (the “Company”), we submit this letter in response to the comments (the “Comments”) received from the staff (the “Staff”) of the Securities and Exchange Commission (the “Commission”) by letter dated June 21, 2024 (the “Comment Letter”) with respect to the Company’s Amendment No. 1 to Confidential Draft Registration Statement on Form S-1 submitted to the Commission on June 10, 2024 (the “DRS Amendment No. 1”). Concurrently with the submission of this response letter, the Company is filing a Registration Statement on Form S-1 (the “Registration Statement”). In addition to addressing the Comments raised by the Staff in its Comment Letter, the Company has included other revisions and updates to its disclosures in the Registration Statement. For ease of reference, set forth below are the Company’s responses to the Comments. The numbering of the paragraphs below corresponds to the numbering of the comments in the Comment Letter, which for your convenience we have incorporated into this response letter. Page references in the text of this response letter correspond to the page numbers of the Registration Statement Capitalized terms used in this response letter but not otherwise defined herein have the meanings set forth in the Registration Statement. Amendment No. 1 to Draft Registration Statement on Form S-1 submitted June 10, 2024 Our Strengths, page 115 1. We note your response to prior comment 14, which we reissue. Please revise to define terms including “overall response rate,” “complete response,” “partial response,” “ongoing response,” “stable disease,” and “progressive disease,” as determined by the Lugano 2014 criteria. Additionally, explain how such responses are measured using CT and PET imaging assessments in your clinical trials or otherwise advise. Response: In response to the Staff’s comment, the Company has revised its disclosure as requested on pages 116, 117, 125, 132, 133 and 135 of the Registration Statement. Cooley LLP 10265 Science Center Drive San Diego, CA 92121 t: (858) 550-6000 f: (858) 550-6420 cooley.com Page Two AlloNK Clinical Development in LN, page 128 2. You disclose that the primary efficacy endpoint is the overall renal response rate (ORRR) defined as the proportion of subjects having either a complete renal response (CRR) or partial renal response (PRR). Please revise to define terms CRR and PRR. Response: In response to the Staff’s comment, the Company has revised its disclosure as requested on page 130 of the Registration Statement. * * * Please contact me at (858) 550-6157 or Charles S. Kim at (858) 550-6049 with any questions or further comments regarding our response to the Staff’s Comment Letter. Sincerely, Carlos Ramirez cc: Fred Aslan, M.D., President and Chief Executive Officer, Artiva Biotherapeutics, Inc. Neha Krishnamohan, Chief Financial Officer, Artiva Biotherapeutics, Inc. Charles S. Kim, Cooley LLP Matthew T. Bush, Latham & Watkins LLP Anthony Gostanian, Latham & Watkins LLP Cooley LLP 10265 Science Center Drive San Diego, CA 92121 t: (858) 550-6000 f: (858) 550-6420 cooley.com
2024-06-21 - UPLOAD - Artiva Biotherapeutics, Inc. File: 377-07214
United States securities and exchange commission logo
June 21, 2024
Fred Aslan
Chief Executive Officer
Artiva Biotherapeutics, Inc.
5505 Morehouse Drive, Suite 100
San Diego, CA 92121
Re:Artiva Biotherapeutics, Inc.
Amendment No. 1 to Draft Registration Statement on Form S-1
Submitted June 10, 2024
CIK No. 0001817241
Dear Fred Aslan:
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. Unless we note otherwise, any references to prior comments are to comments in our
May 30, 2024 letter.
Amendment No.1 to Draft Registration Statement on Form S-1 submitted June 10, 2024
Our Strengths, page 115
1.We note your response to prior comment 14, which we reissue. Please revise to define
terms including "overall response rate," "complete response," "partial response," "ongoing
response," "stable disease," and "progressive disease," as determined by the Lugano 2014
criteria. Additionally, explain how such responses are measured using CT and PET
imaging assessments in your clinical trials or otherwise advise.
AlloNK Clinical Development in LN, page 128
2.You disclose that the primary efficacy endpoint is the overall renal response rate (ORRR)
defined as the proportion of subjects having either a complete renal response (CRR) or
FirstName LastNameFred Aslan
Comapany NameArtiva Biotherapeutics, Inc.
June 21, 2024 Page 2
FirstName LastName
Fred Aslan
Artiva Biotherapeutics, Inc.
June 21, 2024
Page 2
partial renal response (PRR). Please revise to define terms CRR and PRR.
Please contact Sasha Parikh at 202-551-3627 or Lynn Dicker at 202-551-3616 if you
have questions regarding comments on the financial statements and related matters. Please
contact Lauren Sprague Hamill at 303-844-1008 or Jason Drory at 202-551-8342 with any other
questions.
Sincerely,
Division of Corporation Finance
Office of Life Sciences
cc: Carlos Ramirez
2024-05-30 - UPLOAD - Artiva Biotherapeutics, Inc. File: 377-07214
United States securities and exchange commission logo
May 30, 2024
Fred Aslan
Chief Executive Officer
Artiva Biotherapeutics, Inc.
5505 Morehouse Drive, Suite 100
San Diego, CA 92121
Re:Artiva Biotherapeutics, Inc.
Draft Registration Statement on Form S-1
Submitted May 3, 2024
CIK No. 0001817241
Dear Fred Aslan:
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
Cover Page
1.We note your disclosure on page 70 that there will be a concentration of ownership post-
offering, such that certain stockholders will have the ability to control or significantly
influence all matters submitted to stockholders for approval. Please tell us whether you
will be considered a "controlled company" within the meaning of Nasdaq listing standards
post-offering. If so:
•Provide appropriate disclosure of your controlled company status on the prospectus
cover page and revise the prospectus where appropriate throughout to indicate that
you will be a “controlled company" and the implications of such status, including
whether you plan to utilize any of the exemptions available to you.
•Also revise the Prospectus Summary to address the risks of being a shareholder in a
controlled company, and include information regarding the controlling shareholders
and their ability to impact your company and its stated business strategies.
FirstName LastNameFred Aslan
Comapany NameArtiva Biotherapeutics, Inc.
May 30, 2024 Page 2
FirstName LastNameFred Aslan
Artiva Biotherapeutics, Inc.
May 30, 2024
Page 2
Overview, page 1
2.We note your statement that you are developing "allogeneic, off-the-shelf, natural killer
(NK) cell-based therapies." Please revise your disclosure here to clarify, at first use,
what you mean by "allogeneic" and "off-the-shelf."
3.We refer to your statements on pages 1,108, and 113 that you believe your "critical first
mover advances, supported by [y]our rapid and strategic execution, will solidify [y]our
leadership in multiple autoimmune diseases with high unmet need." Please balance your
disclosure by clarifying that the receipt of INDs or FDA designations does not guarantee
that a product candidate will successfully complete the regulatory approval process and
highlight that Artiva has yet to develop an approved product. In addition, please clarify
what you mean when you state your first mover advances are supported by "rapid and
strategic execution."
4.We note that your lead product candidate, AlloNK, is being investigated in a basket
investigator-initiated trial (IIT) in multiple autoimmune indications. Please expand your
disclosure here and throughout as appropriate to:
•Briefly clarify the nature of a basket trial;
•Identify the investigator(s) in the IIT; and
•Explain how an IIT differs from a trial sponsored by your company, and your
role/responsibility, if any, in "supporting" the IIT.
In addition, in an appropriate place in the Business section, please describe the material
terms of any agreement(s) with the investigator(s) so that investors understand the nature
of your rights or obligations in relation to the IIT. File the agreements as exhibits to your
registration statement if required by Item 601 of Regulation S-K, or advise.
B-Cell Driven Autoimmune Disease Background, Prevalence and Unmet Need, page 2
5.Please revise your disclosure throughout your prospectus to remove or revise statements
that state, conclude, or imply the safety or efficacy of your product candidates or
treatment approach, as determinations of safety and efficacy are solely within the
authority of the FDA and comparable regulatory bodies. You may provide a summary of
the objective observations from your trials without stating your conclusions or predictions.
Please refer to the following non-exhaustive list by way of example only:
•"Autoimmune disease treatment approach validated through scientific publications
and our ongoing clinical trial" (pages 4 and 112). In this regard, we note that your
approach to the development of NK cell-based product candidates for the treatment
of any disease is unproven, your products are in an early development stage, and you
may not succeed in demonstrating efficacy and safety for any product candidates in
clinical trials.
•"Conversely, safety data results for AlloNK in combination with rituximab, as of
April 8, 2024, have demonstrated the ability of AlloNK to be administered and
managed in an outpatient setting, with limited risk of required hospitalization."
FirstName LastNameFred Aslan
Comapany NameArtiva Biotherapeutics, Inc.
May 30, 2024 Page 3
FirstName LastNameFred Aslan
Artiva Biotherapeutics, Inc.
May 30, 2024
Page 3
(pages 2, 109, and 114).
•"Once safety is determined, AlloNK will be given at four billion total cells per
dose..." (page 124).
6.Please revise to explain the basis for assuming a treatment regimen of six billion AlloNK
cells total per patient or otherwise advise.
AlloNK Overview, page 3
7.You disclose that AlloNK in combination with rituximab or obinutuzumab for patients
with class III or IV LN has been granted Fast Track designation by the FDA, as has
AlloNK for intravenous (IV) infusion in combination with rituximab for the treatment of
relapsed or refractory B-NHL. Please expand your disclosure here and elsewhere as
appropriate to explicitly state that Fast Track designation does not guarantee a faster
development process, regulatory review, or approval as compared to the conventional
FDA review process.
Manufacturing Capabilities, page 4
8.We note statements here and throughout the registration statement that your proprietary
manufacturing process is designed to allow for the production of NK cell therapy
candidates at a "massive scale," that the scalability of your process creates potential to
expand treatment access "to the hundreds of thousands of autoimmune patients," that
AlloNK can be manufactured at scale, or that your processes "allow for scalable and cost
effective AlloNK production." Throughout, please revise to qualify these and any similar
statements. In this regard we contrast certain of your other disclosures that:
•the manufacture of cell therapy products is novel and complex;
•the manufacturing processes for certain of your CAR-NK cell product candidates
have not been tested at full scale;
•you have not yet demonstrated an ability to manufacture product at a commercial
scale; and
•your cost of goods production is at an early stage.
Capitalization, page 84
9.Please revise to incorporate the SAFE liability as part of your capitalization and include
bold double lines under the cash, cash equivalents and short-term investments amounts to
clearly distinguish them from your capitalization.
Merck Exclusive License and Collaboration Agreement, page 93
10.Please revise your disclosure to clarify who terminated the Merck Collaboration
Agreement in October 2023, describe the material terms of the termination and clarify the
status of the programs that were under development or otherwise advise.
Critical Accounting Policies and Significant Judgments and Estimates
FirstName LastNameFred Aslan
Comapany NameArtiva Biotherapeutics, Inc.
May 30, 2024 Page 4
FirstName LastNameFred Aslan
Artiva Biotherapeutics, Inc.
May 30, 2024
Page 4
Stock-Based Compensation Expense
Common Stock Valuation, page 105
11.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 IPO and the estimated offering price. This information will help facilitate our
review of your accounting for equity issuances including stock compensation and
beneficial conversion features. Please discuss with the staff how to submit your response.
Business, page 108
12.Throughout this section where appropriate, please revise your discussion of the clinical
trials of your material product candidates that you have conducted, are currently
conducting, or plan to conduct to disclose the primary and secondary endpoints of such
trials, as well as the results as they relate to those endpoints.
13.We note that you discuss preclinical trials in this section without providing proper context
for your observations. For each material pre-clinical trial discussed, please briefly describe
how the tests were conducted, the number of animal models used, the number of tests
conducted, the range of results or effects observed in these tests and how such results were
measured.
Our Strengths, page 112
14.We note that your disclosures in this section and elsewhere throughout reference terms
such as "overall response rate," "complete response", "partial response," "ongoing
response," "durable response," "stable disease" and "progressive disease." Please revise to
explain the meaning of these terms and how responses were measured.
Clinical Responses in B-NHL, page 119
15.Your clinical trial results or your product candidate's performance in such trials should not
be compared to alternative trials and technologies unless head to head studies were
conducted. In this regard, please remove the third paragraph in this section referencing
the JULIET, ZUMA-1, and TRANSCEND trials of auto CAR-T cell therapies in B-cell
lymphoma patients, as the inclusion of this information appears to assume or imply that
AlloNK is more effective than other products. Similarly, please remove the following
statement from your discussion of drug-related hospitalization days following dosing of
AlloNK on page 121: "In the study of CD19 auto-CAR-T led by Schett, ten days
mandatory hospitalization was required for all patients."
AlloNK Patient Journey, page 120
16.Please revise the graphic on page 121 and any other tables or graphics throughout your
filing to ensure that the text in each, including subscript or other notations, are clearly
FirstName LastNameFred Aslan
Comapany NameArtiva Biotherapeutics, Inc.
May 30, 2024 Page 5
FirstName LastNameFred Aslan
Artiva Biotherapeutics, Inc.
May 30, 2024
Page 5
legible without need for magnification.
AlloNK, page 122
17.You state that you have completed enrollment in your Phase 1/2 trial exploring AlloNK in
patients with relapsed or refractory B-NHL, and that you have deprioritized further
development of AlloNK in B-NHL but will continue to follow patients to assess duration
of responses. Please revise to explain the reason(s) for this deprioritization or otherwise
advise.
Preliminary Safety Data, page 127
18.Please revise this section to describe all serious adverse events that occurred in your
clinical trials and quantify the number of occurrences, if any.
Intellectual Property, page 133
19.In relation to the company's material patents, please revise your intellectual property
disclosure to clearly describe on an individual or patent family basis the jurisdiction,
including any foreign jurisdiction, of each material pending or issued patent.
Collaboration and License Agreements, page 135
20.We note your disclosure that the Core Agreement and the AB-101, AB-201 and AB-205
license agreements will remain in effect until the expiration of the last-to-expire royalty
term. For each agreement, please revise to clarify when the patents underlying the royalty
term are expected to expire.
Corporate Philanthropy, page 157
21.You state that you have joined the Pledge 1% Movement, and as such, your board of
directors approved the reservation of shares of common stock that you may issue to or for
the benefit of a charitable foundation established by you or other charities in equal
installments over five years following this offering. As appropriate, please add risk factor
disclosure related to your participation in the Pledge 1% Movement, including but not
limited to disclosing, if true, that the donation of such shares may dilute shareholders'
ownership of the company's common stock.
Notes to Financial Statements
8. Collaboration, Option, and License Agreements
Option and License Agreement with GC Cell, page F-18
22.On page F-19 you state that you have exercised your rights to license four option
candidates, one of which is AB-202, under the GC Cell license agreement. Please include
a discussion with regards to the AB-202 selected product agreement or explain why a
discussion is not provided.
FirstName LastNameFred Aslan
Comapany NameArtiva Biotherapeutics, Inc.
May 30, 2024 Page 6
FirstName LastName
Fred Aslan
Artiva Biotherapeutics, Inc.
May 30, 2024
Page 6
General
23.Please supplementally provide us with 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 Section 5(d) of the
Securities Act, whether or not they retain copies of the communications.
Please contact Sasha Parikh at 202-551-3627 or Lynn Dicker at 202-551-3616 if you
have questions regarding comments on the financial statements and related matters. Please
contact Lauren Hamill at 303-844-1008 or Jason Drory at 202-551-8342 with any other
questions.
Sincerely,
Division of Corporation Finance
Office of Life Sciences