Correspondence 0001193125-23-245689 from Neurogene Inc. (NGNE)
Neurogene Inc.
Date: Sept. 28, 2023 · CIK: 0001404644 · Accession: 0001193125-23-245689
AI Filing Summary & Sentiment
File numbers found in text: 333-274095
Referenced dates: September 18, 2023
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CORRESP 1 filename1.htm CORRESP September 28, 2023 VIA EDGAR U.S. Securities and Exchange Commission Division of Corporation Finance Office of Life Sciences 100 F Street, N.E. Washington, DC 20549-3628 Attention: Sasha Parikh, Angela Connell, Doris Stacey Gama, Tim Buchmiller Re: Neoleukin Therapeutics, Inc. Registration Statement on Form S-4 Filed on August 21, 2023 File No. 333-274095 Ladies and Gentlemen: We are submitting this letter on behalf of Neoleukin Therapeutics, Inc. (the “Company”) in response to the comments of the staff (the “Staff”) of the U.S. Securities and Exchange Commission (the “Commission”) contained in the Staff’s letter dated September 18, 2023 (the “Letter”), regarding the Company’s Registration Statement on Form S-4 (File No. 333-274095) initially filed on August 21, 2023 (the “Registration Statement”). Concurrently herewith, we are transmitting Amendment No. 1 to the Registration Statement (“Amendment No. 1”). The numbered paragraphs below correspond to the numbered comments in the Letter and the Staff’s comments are presented in bold. In addition to addressing the comments raised by the Staff in the Letter, the Company has revised Amendment No. 1 to update certain other disclosures. Capital terms used and not otherwise defined herein have the same meanings as specified in the Registration Statement. Cover Page 1. We note your disclosure that the closing of the Neurogene pre-closing financing is conditioned upon the satisfaction or waiver of the conditions to the closing of the merger. Please also clarify if the merger is conditioned upon the Neurogene pre-closing financing. In response to the Staff’s comment, we have revised Amendment No. 1 on the cover page and on pages 3 and 31. Questions and Answers About the Merger Why are the two companies proposing to merge?, page 2 Securities and Exchange Commission September 28, 2023 Page 2 2. We note the disclosure that NGN-401 is a potentially “best-in-class” gene therapy for the treatment of Rett syndrome. Please revise references to “best-in-class” as this could imply an expectation of regulatory approval and appears to be speculative given the length of time and uncertainty with respect to securing marketing approval. If your intention is to convey your belief that Neurogene’s platform or product candidates utilize a novel technology or approach, you may discuss how the technology differs from technology used by competitors. In response to the Staff’s comment, we have revised Amendment No. 1 on page 2. 3. If appropriate, please revise to explain that if the merger is completed, the combined company will focus on developing Neurogene’s product candidates, and it is anticipated that the combined company will not continue to develop Neoleukin’s legacy product candidates. In response to the Staff’s comment, we have revised Amendment No. 1 on page 2. What proposals will be voted on at the Neoleukin special meeting…?, page 3 4. You state that pursuant to the terms of the Merger Agreement, the following proposals must be approved in order for the merger to close and proceed to list Proposal Nos. 1, 2, and 4. In the same section you also state that the approval of Proposal No. 1 is a condition to completion of merger and approval of either or both Proposal Nos. 2 and 4 will be required to complete the merger. Please revise for consistency. In response to the Staff’s comment, we have revised Amendment No. 1 on page 3. What are contingent value rights (“CVRs”)?, page 4 5. We note from your disclosure on page 222 that you entered into an exclusive license agreement with the University of Washington where you were granted exclusive licenses and that you have also licensed rights to patents and own certain patents. Please clarify whether any of those assets are covered by the CVR Agreement. In response to the Staff’s comment, we have revised Amendment No. 1 on page 226. Will the common stock of the combined company trade on an exchange?, page 7 6. We note your disclosure that the shares of the combined company are expected to be listed on Nasdaq. Please revise to disclose if the terms of the merger agreement permit that the Nasdaq listing closing condition could be waived without recirculation or resolicitation. If so, please revise your risk factors to reflect the risks associated with any such waiver and revise to indicate that shareholders may not have certainty at the time of the vote that the shares of the combined company will be listed on Nasdaq following the merger or revise your disclosure in a pre-effective amendment as appropriate if and when there is more certainty regarding the Nasdaq listing of the shares of the combined company. In response to the Staff’s comment, we have revised Amendment No. 1 on pages 7, 27, 30 and 148. Securities and Exchange Commission September 28, 2023 Page 3 Prospectus Summary Neoleukin’s Reasons for the Merger, page 13 7. Please balance your discussion here, as you do on page 117, to provide summary disclosure of the risks and other countervailing factors associated with your merger agreement that were considered by the board of directors of Neoleukin when it voted to approve the merger agreement. In response to the Staff’s comment, we have revised Amendment No. 1 on page 15. Lock-Up Agreements, page 23 8. You state that certain of Neurogene’s executive officers, directors, and stockholders have entered into lock-up agreements. Please revise to disclose when the lock-up agreements will terminate as you do on page 176. In response to the Staff’s comment, we have revised Amendment No. 1 on page 24. The Merger Background of the Merger, page 105 9. You disclose that the transaction committee considered an initial 59 pharmaceutical companies and contacted 56 of those parties to determine their interest in a potential strategic transaction with Neoleukin. Please describe the criteria evaluated that helped the transaction committee determine which parties to contact to determine interest. In response to the Staff’s comment, we have revised Amendment No. 1 on page 108. 10. We note that at the meeting on March 5, 2023, representatives of Leerink Partners provided an update on the status of the outreach to the 16 potential reverse merger counterparties selected by the transaction committee to prioritize. Please include a description of the update provided. In response to the Staff’s comment, we have revised Amendment No. 1 on pages 109 to 110. 11. We note that on March 9, 2023 the transaction committee identified Neurogene as a potential reverse merger counterparty. Please state how the transaction committee identified and initiated contact with Neurogene. In response to the Staff’s comment, we have revised Amendment No. 1 on page 110. 12. We note that on April 6, 2023 the Neoleukin’s board of directors determined to proceed with detailed due diligence on three potential counterparties. Please discuss how the board of directors selected Neurogene, Party A, and Party B. In response to the Staff’s comment, we have revised Amendment No. 1 on pages 112 to 113. Securities and Exchange Commission September 28, 2023 Page 4 Financial Forecasts, page 122 13. We note from your chart on page 123 that Neurogene expects to receive total adjusted net revenues revenue in 2030, peaking in 2036, and beginning to decline thereafter. Please make clear what assumptions underlie these financial projections. In response to the Staff’s comment, we have revised Amendment No. 1 on page 125. Opinion of Leerink Partners to the Neoleukin Board of Directors Valuation Analysis - Discounted Cash Flow, page 128 14. We note the disclosure on page 129 that Leerink Partners’ analysis resulted in an implied exchange ratio of approximately 2.6214x to 3.2989x. Please revise to state any conclusions Leerink Partners reached regarding the exchange ratio of 1.7378x used for purposes of the merger agreement based on the results of the discounted cash flow analysis. In response to the Staff’s comment, we have revised Amendment No. 1 on page 132. Additional Factors Observed by Leerink Partners..., page 129 15. We note the disclosure on page 130 that Leerink Partners compared the resulting implied exchange ratio range from selected public companies of 1.0184x to 2.4707x to the estimated exchange ratio of 1.7378x. Please revise to state any conclusions Leerink Partners reached regarding the exchange ratio used for purposes of the merger agreement based on the results of the comparative public companies. In response to the Staff’s comment, we have revised Amendment No. 1 on page 133. Neoleukin’s Business UW License Agreement, page 222 16. You state on page 223 that the Exclusive License Agreement with the University of Washington will expire upon the expiration of the last valid claim within the licensed patent rights. Please include the expected expiration date or otherwise advise. In response to the Staff’s comment, we have revised Amendment No. 1 on page 226. Neurogene’s Business Neurogene’s Team and Investors, page 242 Securities and Exchange Commission September 28, 2023 Page 5 17. You state that since inception, Neurogene has raised approximately $245 million of capital from premier life science and mutual fund institutional investors, including funds and accounts managed by Blackrock, Cormorant Asset Management, EcoR1 Capital, Janus Henderson Investors, Redmile Group, Samsara BioCapital, and a healthcare investment fund. Please indicate that Neoleukin’s stockholders should not rely on the named investors’ investment decisions, that these investors may have different risk tolerances and, if true, that the securities purchased by those investors may have been conducted at a significant discount to price reflected in the merger agreement. In response to the Staff’s comment, we have revised Amendment No. 1 on page 245. We respectfully advise the Staff that the legacy institutional advisors of Neurogene did not purchase their securities at a discount to the price reflected in the merger agreement. Neurogene’s Pipeline, page 244 18. We note your pipeline table includes a row for a product candidate labeled “Early Discovery.” Please limit your table to product candidates that are sufficiently material to Neurogene to warrant inclusion. If you believe such product candidate is sufficiently material, please explain why and identify the product candidate and indication In response to the Staff’s comment, we have revised Amendment No. 1 on page 247. 19. Please include a Phase 3 column in the pipeline table or otherwise advise. In response to the Staff’s comment, we have revised Amendment No. 1 on page 247. We supplementally advise the Staff that gene therapy products do not follow the traditional clinical development paradigm. Because of the nature of Neurogene’s gene therapy programs, which are being developed for patients with rare neurological diseases with high unmet medical need, its product candidates begin clinical evaluation in Phase 1/2 trials. The initial data collected from these Phase 1/2 trials may allow adaptation to integrate a pivotal trial design within a single study as opposed to the conduct of a separate classic Phase 3 trial. This may ultimately accelerate the approval process and allow the collection of confirmatory efficacy data post-approval. Accordingly, Neurogene intends to work with the regulators to eschew the conduct of separate Phase 3 trials for its product candidates, and may, after completion of a Phase 1/2 trial, in accordance with regulatory authority guidelines and guidance, evaluate its product candidates in a pivotal trial. As a result, Neurogene has added a “Pivotal” trial column instead of a “Phase 3” trial column to its pipeline table in response to the Staff’s comment. NGN-401 Phase 1/2 Clinical Trial, page 248 20. We note that Neurogene received clearance for its IND application from the FDA in January 2023 with enrollment advancing as planned in the second half of 2023. Please update your disclosure to clarify whether enrollment has begun or whether your timeline has been delayed. In response to the Staff’s comment, we have revised Amendment No. 1 on pages 13, 244, 251, 259 and 296. 21. You state that key pillars of your preclinical evidence demonstrated a “favorable safety profile.” Since safety is a determination that is within the authority of the FDA, please revise or remove these statements and similar statements throughout your prospectus. Note that you may state your product candidate has been well tolerated, if accurate. In response to the Staff’s comment, we have revised Amendment No. 1 on page 252. Bridging Sheep Study Comparing Ovine and Human CLN5 Transgene Administration, page 252 22. You state Neurogene plans to have a CMC meeting with the FDA in the second half of 2023. Please update your disclosure to clarify whether you have already met with the FDA, if you plan to meet towards the end of 2023, or whether your timeline has been delayed. In response to the Staff’s comment, we have revised Amendment No. 1 on page 255. Securities and Exchange Commission September 28, 2023 Page 6 Intellectual Property, page 254 23. Please revise the disclosure in this section to more clearly describe the type of patent protection being sought (composition of matter, use, or process) in Neurogene’s owned or in-licensed patent applications. Please also clearly distinguish between owned patents and licensed patents. For example, where you disclose that Neurogene owns 24 patent applications, please disclose the material product candidates, product groups or technologies to which those patent applications relate and when those patents would expire if the applications are granted. In response to the Staff’s comment, we have revised Amendment No. 1 on page 257. License Agreements, page 257 24. Please revise to disclose the term and termination provisions for the license agreements described in this section. In response to the Staff’s comment, we have revised Amendment No. 1 on pages 261 and 312. Neurogene Management’s Discussion and Analysis of Financial Condition and Results of Operations Liquidity and Capital Resources, page 303 25. We note your disclosure that Neurogene expects to continue to incur significant expenses and operating losses for the foreseeable future as it advances the clinical development of its product candidates, and that Neurogene expects that its costs will continue to increase significantly, including the costs associated with operating as a public company. We also note the disclosure concerning substantial doubt about Neurogene’s ability to continue as a going concern. Please revise to disclose how the funds available to the post-merger company will be allocated. In particular, discuss whether the funds available to Neurogene after the merger and the pre-closing financing are expected to be sufficient for Neurogene to complete its current clinical trials. Also, clarify whether such funding is expected to be sufficient to operate the combined business for twelve months following the closing of the merger. In response to the Staff’s comment, we have revised Amendment No. 1 on page 308. Unaudited Pro Forma Condensed Combined Financial Information Notes to the Unaudited Pro Forma Condensed Combined Financial Information Transaction Accounting Adjustments, page 333 Securities and Exchange Commission September 28, 2023 Page 7 26. Please address the following as it relates to your pro forma adjustments to reflect the reverse asset purchase, as illustrated by adjustment (d): • Describe the analysis you performed in determining that Neoleukin does not meet the definition of a business. Refer to the guidance in ASC 805-10-55-3A to 55-9. • Explain your basis for determining that the purchase consideration sho