Correspondence 0001193125-24-009465 from LENZ Therapeutics, Inc. (LENZ)
LENZ Therapeutics, Inc.
Date: Jan. 17, 2024 · CIK: 0001815776 · Accession: 0001193125-24-009465
AI Filing Summary & Sentiment
File numbers found in text: 333-275919
Referenced dates: January 4, 2024
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CORRESP 1 filename1.htm CORRESP Goodwin Procter The New York Times Building 620 Eighth Avenue New York, NY 10018 VIA EDGAR January 17, 2024 United States Securities and Exchange Commission Division of Corporation Finance Office of Life Sciences 100 F Street, N.E. Washington, D.C. 20549-3628 Attention: Doris Stacey Gama, Jason Drory, Eric Atallah and Lynn Dicker Re: Graphite Bio, Inc. Registration Statement on Form S-4 Filed December 6, 2023 File No. 333-275919 Ladies and Gentlemen, On behalf of Graphite Bio, Inc. (the “Company”), we are submitting this letter to the Securities and Exchange Commission (the “SEC”) via EDGAR in response to the comment letter from the staff of the SEC (the “Staff”), dated January 4, 2024 (the “Comment Letter”), pertaining to the Company’s above-referenced Registration Statement on Form S-4 (the “Registration Statement”). In connection with such responses, the Company is concurrently filing Amendment No. 1 to the Registration Statement (the “Amended Registration Statement”). For your convenience, the Staff’s comments are summarized in this letter, and each comment is followed by the applicable responses on behalf of the Company. Unless otherwise indicated, page references in the responses correspond to the page numbers in the Amended Registration Statement. Capitalized terms used in this letter but otherwise not defined herein shall have the meanings set forth in the Amended Registration Statement. Registration Statement on Form S-4 Cover Page 1. Please revise the cover page to disclose, if true, whether the listing approval for LENZ Therapeutics, Inc.’s securities on the Nasdaq is a closing condition of the merger and that the condition will not be waived. Response: The Company respectfully acknowledges the Staff’s comment and advises the Staff that it has revised the disclosure on the Cover Page of the Amended Registration Statement in response to the Staff’s comment to state that the listing approval for LENZ Therapeutics, Inc.’s securities on the Nasdaq is a closing condition of the merger and that such condition is not expected to be waived. U.S. Securities and Exchange Commission Division of Corporation Finance Office of Life Sciences January 17, 2024 Page 2 2. You state that at Graphite’s special meeting, Graphite will ask its stockholders to vote on five proposals and proceed to list and briefly describe such proposals. Please revise proposals number three and four to clarify the “2024 Plan” is a plan to approve the combined company’s 2024 Equity Incentive Plan and the “2024 ESPP” is a plan to approve the combined company’s 2024 Employee Stock Purchase Plan. Response: The Company respectfully acknowledges the Staff’s comment and advises the Staff that it has revised the disclosure on the Cover Page of the Amended Registration Statement in response to the Staff’s comment. Questions and Answers About the Merger Why are the two companies proposing to merge?, page 2 3. We note your disclosure here that “combining the two companies will result in a combined company with a robust pipeline, a strong leadership team and substantial capital resources, positioning it to become a pre-eminent biopharmaceutical company focused on developing LENZ’s product candidates, LNZ100 and LNZ101.” Please provide your basis for the statement or otherwise revise. The statement that the combined company is positioned to become a “pre-eminent” biopharmaceutical company with a “robust pipeline” appears to be premature given your current stage of development and your disclosure elsewhere that LENZ’s business depends entirely on the development and commercialization of LNZ100 or LNZ101. Response: The Company respectfully acknowledges the Staff’s comment and advises the Staff that it has revised the disclosure on page 2 of the Amended Registration Statement in response to the Staff’s comment. 4. Please revise your disclosure to clarify the combined company’s plans with respect to Graphite’s legacy assets. We note that your disclosure on page 278 that, “Graphite has no remaining ongoing development programs.” Response: The Company respectfully acknowledges the Staff’s comment and advises the Staff that it has revised the disclosure on page 2 of the Amended Registration Statement in response to the Staff’s comment. What will Graphite stockholders receive in the merger?, page 5 5. Briefly explain how the dividend record date and ex-dividend date will impact which Graphite stockholders will be entitled to receive any special cash dividend declared by Graphite. Response: The Company respectfully acknowledges the Staff’s comment and advises the Staff that it has revised the disclosure on pages 5 and 215 of the Amended Registration Statement in response to the Staff’s comment. U.S. Securities and Exchange Commission Division of Corporation Finance Office of Life Sciences January 17, 2024 Page 3 Prospectus Summary The Companies Graphite, page 12 6. We note your disclosure that “Graphite also disclosed its intention to continue research activities associated with its pre-clinical non-genotoxic conditioning program.” However, we note your disclosure elsewhere, including on page 33, that “Graphite transferred to a third party its right to its pre-clinical non-genotoxic conditioning program.” Please update your disclosure here to clarify the pre-clinical non-genotoxic conditioning program has been transferred or otherwise advise. Response: The Company respectfully acknowledges the Staff’s comment and advises the Staff that it has revised the disclosure on page 12 of the Amended Registration Statement in response to the Staff’s comment. The Merger Background of the Merger, page 136 7. You state that out of the 135 initial companies considered, 51 were contacted, and 41 received process letters requesting they submit non-binding indications of interest. Please discuss how you determined which companies were contacted and which were not and which companies received process letters and which did not. Please also identify the general industry of the companies considered or otherwise advise. Response: The Company respectfully acknowledges the Staff’s comment and advises the Staff that it has revised the disclosure on page 136 of the Amended Registration Statement in response to the Staff’s comment. 8. You state on page 137 that the Transaction Committee selected 12 indications of interest to prioritize and invite to make management and due diligence presentations and proceed to describe Parties A-D. Please also include a discussion of the other 8 parties and disclose whether or not they made presentations or otherwise advise. Response: The Company respectfully acknowledges the Staff’s comment and advises the Staff that it has revised the disclosure on page 137 of the Amended Registration Statement in response to the Staff’s comment. The Company respectfully advises the Staff that on page 140 of the Amended Registration Statement, the Company has disclosed that such parties (other than Party J, who withdrew from the process as disclosed in the Amended Registration Statement) presented to the Transaction Committee, Graphite’s management and representatives of Leerink Partners. 9. You state on page 145 that the representatives of Leerink Partners reviewed with the Transaction Committee a list of 31 private and public companies that could be interested in a strategic transaction with Graphite. Please discuss how you identified these companies and the general industry of such companies. U.S. Securities and Exchange Commission Division of Corporation Finance Office of Life Sciences January 17, 2024 Page 4 Response: The Company respectfully acknowledges the Staff’s comment and advises the Staff that it has revised the disclosure on page 146 of the Amended Registration Statement in response to the Staff’s comment. 10. You state on page 145 that you and your “financial and legal advisors” conducted due diligence on multiple potential counterparties. Please revise your disclosure to quantify the approximate number of the potential counterparties that you conducted due diligence on. In addition, please clarify if there were other material legal or financial advisors other than Leerink Partners and Goodwin who participated in the diligence. Response: The Company respectfully acknowledges the Staff’s comment and advises the Staff that it has revised the disclosure on page 146 of the Amended Registration Statement in response to the Staff’s comment. 11. You state that you selected five private companies and Party D to prioritize and include descriptions of Party E, D and Lenz. Please also include a description of the other three parties that you invited to make management and due diligence presentations. Response: The Company respectfully acknowledges the Staff’s comment and advises the Staff that it has revised the disclosure on page 148 of the Amended Registration Statement in response to the Staff’s comment. 12. We note your disclosure on page 151 where you reference “Graphite’s legacy assets.” Please revise your disclosure to clarify if there are any material remaining assets that have not been sold or licensed by Graphite. We note your disclosure elsewhere, including on page 344, where you discuss the asset purchase agreement and license and option agreement for Graphite’s non-genotoxic conditioning technology and Graphite’s nula-cel program, respectively. Response: The Company respectfully acknowledges the Staff’s comment and advises the Staff that it has revised the disclosure on pages 153, 344 and 345 of the Amended Registration Statement in response to the Staff’s comment. 13. We note your disclosure that contingent value rights were included in the initial term sheet with LENZ. We further note your disclosure that “the manner by which Graphite’s stockholders would receive value in respect of potential revenue received from the sale or license of Graphite’s legacy assets, which the parties ultimately agreed would be provided through an increase of $1.5 million in the enterprise valuation of Graphite rather than a post-closing CVR agreement.” Please revise your disclosure to clarify how this number was determined and agreed upon. Response: The Company respectfully acknowledges the Staff’s comment and advises the Staff that it has revised the disclosure on page 153 of the Amended Registration Statement in response to the Staff’s comment. U.S. Securities and Exchange Commission Division of Corporation Finance Office of Life Sciences January 17, 2024 Page 5 14. We note your disclosure on page 344 that Graphite entered into an asset purchase agreement with a third-party pursuant to which Graphite sold to the counterparty, concurrently with the execution of the APA, certain assets related to Graphite’s non-genotoxic conditioning technology and entered into a license and options agreement with a third party pursuant to which Graphite exclusively licensed to the counterparty, and granted the counterparty, an option to acquire certain intellectual property and materials related to Graphite’s nula-cel program and related pre-clinical platform assets. Please revise your Background of the Transaction section to identify the third-party (s), describe the material terms of the agreements and discuss how the material terms were negotiated and agreed upon. Response: The Company respectfully acknowledges the Staff’s comment and advises the Staff that it has revised the disclosure on pages 344 and 345 of the Amended Registration Statement in response to the Staff’s comment. However, the Company respectfully advises the Staff that the Company does not believe that each of the Company’s LOA and APA (as each is defined below in response to Comments 24 and 25, respectively) is a “material contract” for purposes of Item 601(b)(10) of Regulation S-K for the reasons outlined in response to Comments 24 and 25, respectively. As such, the Company’s disclosure identifies the third parties and describes the agreements in a manner the Company believes is sufficient for agreements that are not “material contracts” for purposes of Item 601(b)(10). 15. We note your disclosure on page 143 that the “Graphite board of directors considered outreach efforts made by Graphite to various other prospective purchasers of the assets and noted that despite advanced diligence conducted on the assets by multiple other parties, the NGTC acquirer was the sole bidder for the assets to present a proposal to Graphite.” Please revise your disclosure to describe and quantify the “outreach efforts” and quantify the “multiple other parties” who conducted advanced diligence. Response: The Company respectfully acknowledges the Staff’s comment and advises the Staff that it has revised the disclosure on page 145 of the Amended Registration Statement in response to the Staff’s comment. Certain Unaudited Prospective Financial Information, page 161 16. We note your disclosure that “[on] October 19, 2023, Graphite management received information regarding LENZ’s business and product candidates from LENZ.” Please revise your disclosure to clarify the specific “information” provided by LENZ. Response: The Company respectfully acknowledges the Staff’s comment and advises the Staff that it has revised the disclosure on page 163 of the Amended Registration Statement in response to the Staff’s comment. 17. We see that you have provided projections of estimated annual revenues, operating income and unlevered free cash flow for the years ended December 31, 2024 through 2036. Please revise your disclosure to provide more specific assumptions to enhance an investors understanding of the basis for your projections. For example only, discuss any pricing assumptions used in your projections. U.S. Securities and Exchange Commission Division of Corporation Finance Office of Life Sciences January 17, 2024 Page 6 Response: The Company respectfully acknowledges the Staff’s comment and advises the Staff that it has revised the disclosure on page 165 of the Amended Registration Statement in response to the Staff’s comment. 18. We note your disclosure that Graphite risk-adjusted projections by using certain probabilities of success (“PoS”). We further note your disclosure of a “a cumulative 60% PoS adjustment for U.S. revenue for LNZ100 or LNZ101, assuming only one product candidate would be approved and commercialized.” Please revise your disclosure to describe and clarify with greater specificity how your operating income projections were adjusted or otherwise advise. Response: The Company respectfully acknowledges the Staff’s comment and advises the Staff that it has revised the disclosure on page 166 of the Amended Registration Statement in response to the Staff’s comment. However, the Company respectfully advises the Staff that the Company did not make any adjustments to the operating income itself, but the operating expenses used to determine the operating income. 19. We note your assumption that you assumed “LENZ’s product candidate becomes commercially available in the U.S. in 2025” and a “3-month delay in launch timing.” Please clarify with greater specificity the particular timeframe you used for your projections. We note your disclosure on page 307 that LENZ anticipates “a launch target date in mid-2025.” Response: The Company respectfully acknowledges the Staff’s comment and advises the Staff that it has revised the disclosure on page 165 of the Amended Registration Statement in response to the Staff’s comment. 20. We note your risk factor disclosure on page 69 where you state “LENZ’s business depends entirely on the development and commercialization of LNZ100 or LNZ101, and LENZ does not have additional product candidates in its current development pipeline…LENZ currently generates no revenues from sales of any p