Correspondence 0001193125-24-170647 from TuHURA Biosciences, Inc./NV (HURA)
TuHURA Biosciences, Inc./NV
Date: June 27, 2024 · CIK: 0001498382 · Accession: 0001193125-24-170647
AI Filing Summary & Sentiment
File numbers found in text: 333-279368
Referenced dates: June 7, 2024
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CORRESP 1 filename1.htm CORRESP June 27, 2024 VIA EDGAR Securities and Exchange Commission Division of Corporation Finance Office of Industrial Applications and Services 100 F Street, N.E. Washington, D.C. 20549 Attention: Tara Harkins Vanessa Robertson Tyler Howes Alan Campbell Re: Kintara Therapeutics, Inc. Registration Statement on Form S-4 Filed May 13, 2024 File No. 333-279368 Ladies and Gentlemen: This letter is submitted on behalf of Kintara Therapeutics, Inc. (the “Company” or “Kintara”) in response to comments from the staff (the “Staff”) of the Securities and Exchange Commission (the “Commission”) contained in the letter dated June 7, 2024 (the “Comment Letter”) regarding the Company’s Registration Statement on Form S-4 filed with the Commission on May 13, 2024 (the “Registration Statement”). In connection with this response to the Comment Letter, the Company is contemporaneously filing an amendment to the Registration Statement (“Amendment No. 1”), to address the Staff’s comments in the Comment Letter and updating the Registration Statement. The following are the Company’s responses to the Comment Letter. For your convenience, the Staff’s comments contained in the Comment Letter have been restated below in their entirety in italic type, with the Company’s corresponding responses set forth immediately under such comments, including, where applicable, a cross-reference to the location of changes made in Amendment No. 1 in response to the Staff’s comment. All page references in the responses set forth below refer to page numbers in Amendment No. 1. Defined terms used but not otherwise defined herein have the meanings ascribed to such terms in Amendment No. 1. Registration Statement on Form S-4 filed on May 13, 2024 Cover Page 1. Please revise the Letter to Stockholders to disclose whether the listing approval for TuHURA’s securities on Nasdaq is a closing condition of the merger. RESPONSE: The Company acknowledges the Staff’s comment and has revised the disclosure on the Cover Page of Amendment No. 1 to reflect the Staff’s comment. 2. We note your reference to TuHURA’s “first-in-class” bi-functional ADCs. Please remove this claim as well as any other similar claims in the prospectus as it appears to be premature given TuHURA’s current stage of development. RESPONSE The words “first-in-class” have been deleted in the two places in which they previously appeared in the Registration Statement (the cover page and in Note 1 to the Consolidated Financial Statements of TuHURA). Questions and Answers About the Merger, page 1 3. Please revise this section to prominently disclose the valuations attributed to both Kintara and TuHURA in the merger. Please also clarify, if true, that the ownership percentages of the post-merger combined company include the conversion of the convertible notes issued by TuHURA in the TuHURA Note Financing. RESPONSE: The Company acknowledges the Staff’s comment and has revised the disclosure on page 1 of Amendment No. 1 to reflect the Staff’s comment. 4. Please include a Q&A discussing the proposed reverse split and how it will impact the voting power of Kintara shareholders in the combined company. RESPONSE: The Company acknowledges the Staff’s comment and has revised the disclosure on page 4 of Amendment No. 1 to reflect the Staff’s comment. 5. Please revise this section to add a Q&A discussing the reasons why Kintara’s board of directors is recommending that Kintara’s stockholders approve the merger, the reverse split and the associated transactions. In your new Q&A, please discuss whether Kintara’s board of directors considered any potential downsides or uncertainties related to these proposals. RESPONSE: The Company acknowledges the Staff’s comment and has revised the disclosure on pages 3 and 4 of Amendment No. 1 to reflect the Staff’s comment. 6. Please revise your disclosure in this section to discuss the impact that a potential delisting of Kintara’s common stock from Nasdaq would have on the Merger. In your revisions, clarify if you have entered into discussions with Nasdaq related to your potential delisting and tell us the status of any such discussions. RESPONSE: The Company acknowledges the Staff’s comment and has revised the disclosure on page 5 of Amendment No. 1 to reflect the Staff’s comment. 7. We note that this question currently discusses a number of topics including the reasons for receiving this proxy statement/prospectus, the exchange ratio and the contingent value rights agreements that Kintara will enter into at the time of the merger. Please separate this Q&A into three separate questions discussing: • The reasons why shareholders are receiving this proxy statement/prospectus • The exchange ratio, including a brief explanation what it is and how it will be calculated • The contingent value rights agreements and a discussion of what rights will flow to shareholders from these agreements RESPONSE: The Company acknowledges the Staff’s comment and has revised the disclosure on pages 1-2 of Amendment No. 1 to reflect the Staff’s comment. Summary of the Proxy Statement/Prospectus TuHURA, page 12 8. We note your statements here and throughout the prospectus that TuHURA’s IFx technology and product candidates are “personalized.” However, your disclosure elsewhere in the prospectus appears to indicate that the composition of TuHURA’s IFx product candidates does not vary from patient to patient. Accordingly, please tell us why it is appropriate to characterize TuHURA’s technology and product candidates as “personalized.” Alternatively, please remove this claim. RESPONSE: TuHURA respectfully advises the Staff that the characterization of IFx-2.0 as a “personalized” cancer vaccine is appropriate and consistent with the usage of the term in the scientific and medical industry. IFx-2.0 is “personalized” in that it utilizes each individual patient’s tumor itself as the source of tumor neoantigens. It does so by controlling the activation of tumor-specific T cells through the priming of an innate immune response against the Emm55 immunogenic bacterial protein expressed on the surface of the tumor cell following IFx-2.0 intratumoral administration. Because each individual patient’s tumor’s neoantigens are unique to that patient’s tumor, IFx-2.0 represents a truly individualized and personalized endogenous vaccine because it uses the patient’s own tumor and its complement of tumor antigens to activate an immune response against the cancer in vivo. Please also revise the fourth paragraph of this section to clarify that the results of clinical trials are inherently uncertain and that the results from TuHURA’s Phase 3 clinical trial may fail to satisfy the ORR, PFS and OS endpoints. RESPONSE: In response to this comment and Comment #30 below, the following sentence has been added to the end of the fourth paragraph of this section on page 13: “Notwithstanding the foregoing, the results of clinical trials are inherently uncertain, and the results of TuHURA’s planned Phase 3 clinical trial may fail to satisfy the ORR, PFS, and/or OS endpoints, and none of TuHURA’s prior clinical trials with respect to IFx-2.0 were powered to determine statistical significance over a control.” The same sentence has been added following similar disclosure on pages 238 and 248. 9. We note your statement that TuHURA plans to initiate a Phase 1b/2a trial in the third quarter of 2024. Please revise to clarify if there is an active IND for this trial. RESPONSE: A sentence has been added to the end of this paragraph stating that the planned Phase 1b/2a trial is covered by the currently active IND for IFx-2.0. 10. Please revise this section to reflect your disclosure on page 232 indicating that TuHURA must complete additional product testing procedures and gain FDA acceptance of these procedures before it can commence its Phase 3 clinical trial. RESPONSE: In response to this comment, the disclosure from page 232 regarding the additional testing procedures has been included in the Summary. TuHURA Note Financing, page 16 11. Please disclose how the Kintara shareholders would be impacted by the exercise of the warrants issued in connection with the TuHURA Note Financing. For example, explain if this would further dilute the total ownership percentage of Kintara shareholders in the combined company and quantify the amount of such dilution. RESPONSE: Please be advised that the exercise of the warrants issued in connection with the TuHURA Note Financing would have no effect on the total ownership percentage of Kintara shareholders in the combined company as disclosed throughout the registration statement. As provided on pages 14 and 15, for purposes of calculating the Exchange Ratio used to determine the total ownership of Kintara equityholders, all shares of TuHURA Common Stock underlying TuHURA warrants are deemed to be outstanding. As a result, the equity ownership following the merger has been presented on a fully-diluted basis, and there will be no impact by the exercise of the warrants. The Company has revised its disclosure on page 19 of Amendment No. 1 to clarify that there will be no impact relating to any exercise of the TuHURA warrants on the Kintara equityholders. Opinion of Kintara’s Financial Advisor, page 18 12. We note your statements here and elsewhere in the prospectus, as well as in the fairness opinion attached as Annex B, that the opinion is intended for the sole benefit of Kintara’s board of directors and may not be used for any other purpose. Please remove this statement. Alternatively, please disclose the legal basis for your and Lucid’s belief that stockholders cannot rely on the opinion to bring state law actions, including a description of any state law authorities on such a defense. If no such authority exists, please disclose that this issue will be resolved by a court, resolution of this issue will have no effect of on rights and responsibilities of Kintara’s board under state law and the availability or non-availability of this defense has no effect on the rights and responsibilities of either Lucid or Kintara’s board under federal securities laws. RESPONSE: The Company acknowledges the Staff’s comment and has revised the disclosure on page20 and 141 of Amendment No. 1 to reflect the Staff’s comment. Risk Factors TuHURA relies on third parties to manufacture its clinical product supplies..., page 39 13. Please disclose the name of the single source supplier TuHURA current relies on for the manufacturing of TuHURA’s product candidates. In your revisions, clarify if the single source supplier holds any of the necessary know-how required to manufacture TuHURA’s product candidates and if TuHURA has entered into any supply agreements with it. RESPONSE: Please be advised that the language that previously referenced a “single source vendor” has been revised to reflect that TuHURA uses several outside vendors to manufacture supplies and process TuHURA’s product candidates. For the information of the Staff, none of TuHURA’s vendors holds any necessary know-how, as such vendors are CDMOs that perform drug product manufacturing that is fill-finish only. The certificate of incorporation of the combined company will provide that..., page 80 14. We note your disclosure regarding the exclusive forum provision that will be included in the articles of incorporation of the combined company. Please revise to clarify that Section 22 of the Securities Act creates concurrent jurisdiction for state and federal courts over all actions brought to enforce any duty or liability created by the Securities Act or the rules and regulations thereunder. RESPONSE: The Company acknowledges the Staff’s comment and has revised the disclosure on page 82 and revised the exclusive forum language in Article VII of the Delaware Certificate of Incorporation in response to the Staff’s comment. Unaudited Pro Forma Condensed Combined Financial Information , page 107 15. Please revise this note to clearly disclose your fiscal year end once the merger agreement is effective. RESPONSE: The Company acknowledges the Staff’s comment and has revised the disclosure on page 109 in response to the Staff’s comment. 16. We note from proposal 2 on page 1 that you are proposing a reverse stock split of only the outstanding shares of Kintara Common Stock and other outstanding securities of Kintara Common Stock (with no change to the authorized capital stock of Kintara), at a ratio in the range from [ ]-for-1 to [ ]-for-1. Please revise your filing to provide the range of the reverse stock split as well as to update your pro forma financial statements for the impact of the reverse stock split upon your financial statements. Further, to the extent that any such reverse stock split is expected to occur prior to the effectiveness of your registration statement, all share data will require retroactive adjustment pursuant to SAB Topic 4.C. RESPONSE: The Company acknowledges the Staff’s comment and has removed the language regarding effecting a reverse stock split of only the outstanding shares of Kintara Common Stock. The Company informs the Staff that it does not intend to effect reverse stock split prior to effective date of the Registration Statement. The Company is currently analyzing what ratio to utilize and has presented it current expectations for the relevant range in brackets in Amendment No. 1. The Company will update its disclosure in a subsequent amendment to the Registration Statement to disclose the relevant range of ratios to be considered by the Company’s board of directors prior to the effective date of the Registration Statement without brackets once finalized. 17. Reference is made to note (A) on page 118 and that you have reflected the anticipated cash proceeds of $28.6 million within your pro forma balance sheet related to the TuHURA Note Financing. We further note from your discussion on page 16 that you received $31.3 million in subscriptions related to these notes and only $18.5 million were funded as of April 30, 2024. Please tell and revise your filing to disclose why you made a $28.6 million adjustment to the pro forma balance sheet since only $18.5 million were funded as of April 30, 2024. RESPONSE: The Company acknowledges the Staff’s comment and has revised the disclosure in note (A) on page 121 of Amendment No. 1 to clarify that the subscription agreements are legally binding subscriptions that require the investors to unconditionally fund their investments by a specified date in such subscription agreement before the closing of the Merger. 18. Reference is made to adjustment (F) on page 118 and that you have a $0 adjustment reflected within your pro forma financial statements for the contingent right value (CVR) that you believe is probable that the Milestone of the Kintara legacy clinical studies pursuant to the CVR Agreement will be achieved and the CVR shares to be issued. We further note your disclosure that the accounting treatment for the CVR obligation is preliminary in nature and the final accounting treatment will be determined based on a number of factors, including additional analysis of the transaction and consideration of relevant accounting standards. Please tell us and explain in more detail how you plan on accounting for these rights and why you have reflected a $0 impact for these rights. RESPONSE: The Company acknowledges the Staff’s comment and has revised the disclosure in note 1 on page 118 of Amendment No. 1 under the Contingent Value Rights Agreement section with additional discussion on management’s determination of the net zero accounting determination for the CVR, has removed adjustment (F) has expanded its CVR disclosures on page 118 in response to the Staff’s comment. The Merger Background of the Merger, page 124 19. Please revise this sect