Correspondence 0001193125-23-221557 from Tourmaline Bio, Inc. (TRML) (CIK 0001827506)
Tourmaline Bio, Inc. (TRML) (CIK 0001827506)
Date: Aug. 25, 2023 · CIK: 0001827506 · Accession: 0001193125-23-221557
AI Filing Summary & Sentiment
File numbers found in text: 333-273335
Referenced dates: August 16, 2023
Show Raw Text
CORRESP 1 filename1.htm CORRESP Goodwin Procter The New York Times Building 620 Eighth Avenue New York, NY 10018 VIA EDGAR August 25, 2023 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, Tim Buchmillar, Christine Torney and Daniel Gordon Re: Talaris Therapeutics, Inc. Registration Statement on Form S-4 Filed July 19, 2023 File No. 333-273335 Ladies and Gentlemen, On behalf of Talaris Therapeutics, 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 August 16, 2023 (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, and page references otherwise correspond to the page numbers in the 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 What is the Tourmaline pre-closing financing?, page 2 1. Please clarify if the merger is conditioned upon the consummation of the pre-closing financing. 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. U.S. Securities and Exchange Commission Division of Corporation Finance Office of Life Sciences August 25, 2023 Page 2 What will Talaris stockholders receive in the Merger?, page 4 2. Briefly explain how the record date and ex-dividend date will impact which Talaris stockholders will be entitled to receive any special cash dividend declared by Talaris. Response: The Company respectfully acknowledges the Staff’s comment and advises the Staff that it has revised the disclosure on page 4 of the Amended Registration Statement in response to the Staff’s comment. Will the common stock of the combined company trade on an exchange?, page 5 3. 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. Response: The Company respectfully acknowledges the Staff’s comment and advises the Staff that it has revised the disclosure on pages 5 and 143 of the Amended Registration Statement in response to the Staff’s comment. Prospectus Summary Tourmaline, page 10 4. You state that Tourmaline is a late-stage clinical biotechnology company. Please revise references to late-stage given that Tourmaline’s leading product candidate, TOUR006, has recently submitted its IND application to the FDA and has not begun clinical trials. 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 to clarify that Tourmaline has received IND clearance from the United States Food and Drug Administration (the “FDA”) to conduct a Phase 2b clinical study for TOUR006 in patients with Thyroid Eye Disease. This differentiates TOUR006 from a pre-clinical drug candidate which is still undergoing in vitro (laboratory) and in vivo (animal) studies to gather safety and other evidence to justify clinical trials in humans. Additionally, TOUR006 has completed six other Phase 1 or Phase 2 trials conducted by Pfizer, the results of which were included in support of Tourmaline’s now cleared IND for Thyroid Eye Disease. This also differentiates TOUR006 from an early-stage clinical drug candidate which may just be entering or may currently be in a Phase 1 or initial Phase 2a study. Therefore, the Company respectfully advises the Staff that it believes the use of “late-stage clinical” to describe Tourmaline’s development status is accurate and not misleading. U.S. Securities and Exchange Commission Division of Corporation Finance Office of Life Sciences August 25, 2023 Page 3 5. We note your disclosure here and throughout your prospectus regarding TOUR006 having the potential to be “best-in-class.” Please remove references to “best-in-class” as this implies an expectation of regulatory approval and is inappropriate given the length of time and uncertainty with respect to securing marketing approval. If your intention is to convey your belief that your platform or your programs utilize a novel technology or approach, you may discuss how your technology differs from technology used by competitors. Statements such as these should be accompanied by cautionary language that the statements are not intended to give any indication that your technology or any potential product candidates have been proven effective or will receive regulatory approval. Response: The Company respectfully acknowledges the Staff’s comment and advises the Staff that it has revised the disclosure on page 309 and subsequently throughout the Amended Registration Statement in response to the Staff’s comment. The Merger Background of the Merger, page 151 6. We note that Talaris management and representatives from Leerink Partners developed a list of 43 potential counterparties for the potential reverse merger transaction that was approved by the S&T Committee and that of the 43 potential counterparties, Leerink Partners distributed process letters on behalf of Talaris to 28 companies that the S&T Committee determined to be the most viable counterparties. Please describe the criteria the S&T Committee used in determining which counterparties should receive the process letters and which should not. Response: The Company respectfully acknowledges the Staff’s comment and advises the Staff that it has revised the disclosure on page 156-158 of the Amended Registration Statement in response to the Staff’s comment. 7. We note that on March 15, 2023 Tourmaline management shared a non-confidential corporate presentation with Leerink Partners who then shared it with the S&T Committee. Please discuss the contents of the presentation that would be material to Talaris’ stockholders. Response: The Company respectfully acknowledges the Staff’s comment and advises the Staff that it has revised the disclosure on page 161 of the Amended Registration Statement in response to the Staff’s comment. 8. You state that on March 31, 2023 members of the S&T Committee discussed outreach they had received from certain potential counterparties. Please discuss who the parties were and what was the context of the outreach. Response: The Company respectfully acknowledges the Staff’s comment and advises the Staff that it has revised the disclosure on page 162 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 August 25, 2023 Page 4 9. We note that on April 11, 2023 the S&T Committee decided to not advance with Party N. Please include a description for the reasons the S&T Committee decided to not move forward with Party N. 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. 10. You state that on April 14, 2023 the S&T Committee selected to prioritize the indications of interest from Tourmaline, Party B, Party C, and Party H and that the S&T Committee decided to not move forward with the other 10 participants. We note that only 15 potential counterparties submitted indications of interest and that on March 16, 2023 the S&T Committee communicated to Parties F, G, I, J, and L that they were not invited to move forward with the reverse merger process. Please clarify who the other 10 participants that were not invited to move forward on April 14, 2023 are. 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. 11. We note that on April 14, 2023 the S&T Committee proposed certain revisions to Tourmaline’s transaction proposal. Please clarify if there were any other proposed revisions or counterproposals presented to other potential counterparties. 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. 12. On April 19, 2023 you state that the S&T Committee provided feedback to be incorporated in Talaris’ next counterproposal to Tourmaline. Please discuss such feedback. Response: The Company respectfully acknowledges the Staff’s comment and advises the Staff that it has revised the disclosure on page 164 of the Amended Registration Statement in response to the Staff’s comment. Opinion of Talaris’ Financial Advisor, page 171 13. We note the disclosure on page 174 that for purposes of its analysis, Leerink Partners utilized the estimated exchange ratio of 0.7403 shares of Talaris common stock for each share of Tourmaline, based on Talaris’ and Tourmaline’s respective capitalization as of June 22, 2023. However, this estimated exchange ratio does not appear to be within the range of the exchange ratios disclosed on the cover page which range from 0.7553 to 0.7721. Please enhance the disclosure so that it is clear to investors how Leerink concluded that the exchange ratio proposed to be paid by Talaris pursuant to the terms of the Merger Agreement was fair, from a financial point of view, to Talaris using the estimated exchange ratio of 0.7403. We also note the disclosure on page 175 that Leerink’s analysis resulted in an implied exchange ratio of approximately 1.2235x to 1.5454x. Please revise to state any conclusions Leerink reached regarding the exchange ratio used for purposes of the merger agreement based on the results of the discounted cash flow analysis. U.S. Securities and Exchange Commission Division of Corporation Finance Office of Life Sciences August 25, 2023 Page 5 Response: The Company respectfully acknowledges the Staff’s comment and advises the Staff that it has revised the disclosure on pages 179 and 180 of the Amended Registration Statement in response to the Staff’s comment. Financial Projections, page 179 14. If true, please make clear that the Financial Projections reflect the assumption that appropriate patents would be granted for TOUR006 and, if granted, would not expire until 2043. Please also explain why the Financial Projections were modeled to reflect the estimated impact of loss of market exclusivity for the TED indication in 2039. Response: The Company respectfully acknowledges the Staff’s comment and advises the Staff that it has revised the disclosure on page 184 and 185 of the Amended Registration Statement in response to the Staff’s comment. Tax Characterization of the Merger, page 192 15. We note your representation that Talaris and Tourmaline “intend” for the merger to qualify as a reorganization within the meaning of Section 368(a) of the U.S. Internal Revenue Code of 1986, as amended (the “Code”). Please revise your disclosure here and throughout to provide counsel’s firm opinion for each material tax consequence, including whether the merger will qualify as a reorganization, or to explain why such opinion cannot be given. If the opinion is subject to uncertainty, please (1) provide an opinion that reflects the degree of uncertainty (e.g., “should” or “more likely than not”) and explains the facts or circumstances giving rise to the uncertainty, and (2) provide disclosure of the possible alternative tax consequences including risk factor and/or other appropriate disclosure setting forth the risks of uncertain tax treatment to investors. Please refer to Item 601(b)(8) of Regulation S-K and Section III.A of Staff Legal Bulletin 19, Legality and Tax Opinions in Registered Offerings for guidance. Response: In response to the Staff’s comment, the Company respectfully advises the Staff that, because the Company’s shareholders are not exchanging their shares in the merger, the U.S. federal income tax consequences of the merger are not material to the Company or its shareholders. Regardless of whether the merger qualifies as a reorganization within the meaning of Section 368(a) of the Code, it will not be a taxable transaction to the Company’s shareholders. Whether or not the merger qualifies as a “reorganization” within the meaning of Section 368(a) of the Code will not impact the Company’s shareholders’ decision to approve or not approve the merger or to purchase or sell Company shares (or, following the consummation of the merger, shares of the combined company). Existing Company shareholders will not exchange their Company shares for shares in any other entity, but will simply retain their existing shares in the Company. U.S. Securities and Exchange Commission Division of Corporation Finance Office of Life Sciences August 25, 2023 Page 6 The only parties affected by the qualification of the merger as a “reorganization” under Section 368(a) of the Code are Tourmaline shareholders. However, the Form S-4 is not soliciting the consent of the Tourmaline shareholders to the transactions, and they are not voting in the Talaris special meeting. Rather promptly after the Form S-4 is declared effective under the Securities Act, Tourmaline will disseminate to Tourmaline shareholders an information statement containing all information required to be delivered under Delaware law, including a material description of the merger, the Merger Agreement and related ancillary documents and appraisal rights available under Delaware law, for purposes of soliciting such Tourmaline shareholders’ consent to adopt Merger Agreement and approve the merger. The information statement also will contain information with respect to the qualification of the merger as a “reorganization” within the meaning of Section 368(a) of the Code. In connection with their consideration of the transaction, and based on their review of the information statement, the Tourmaline shareholders can seek advice from their own tax advisors and will be responsible for paying their own taxes, if any, that result from the merger. The Company and its shareholders are not required to indemnify Tourmaline shareholders for such taxes, if any. Securities Purchase Agreement, page 222 16. We note your description of the Securities Purchase Agreement. Please identify each shareholder who, as a result of purchasing securities pursuant to such agreement, is expected to be a beneficial owner of 5% or more of the outstanding