SEC Company Response from Tvardi Therapeutics, Inc. (TVRD) (CIK 0001346830) (TVRD) — Nov 8, 2013
Tvardi Therapeutics, Inc. (TVRD) (CIK 0001346830)
Date: Nov. 8, 2013 · CIK: 0001346830 · Accession: 0001193125-13-435496
AI Filing Summary & Sentiment
Referenced dates: October 31, 2013
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CORRESP 1 filename1.htm SEC Letter Babak Yaghmaie T: (212) 479-6556 F: (212) 479-6275 byaghmaie@cooley.com Via EDGAR and FedEx November 8, 2013 U.S. Securities and Exchange Commission Division of Corporation Finance 100 F Street, N.E. Washington, D.C. 20549 Attn: Mr. Jeffrey P. Riedler Mr. Scot Foley Mr. Bryan J. Pitko Ms. Ibolya Ignat Mr. Andrew Mew Re: Cara Therapeutics, Inc. Draft Registration Statement on Form S-1 Submitted October 4, 2013 CIK No. 0001346830 Ladies and gentlemen: On behalf of our client, Cara Therapeutics, Inc. (“Cara Therapeutics” or the “Company”), we are responding to the comments (the “Comments”) of the staff (the “Staff”) of the Securities and Exchange Commission (the “Commission”) contained in its letter dated October 31, 2013 (the “Comment Letter”), relating to the above referenced Confidential Draft Registration Statement (the “DRS”). We also describe below the changes the Company has made in response to the Comments in the Registration Statement on Form S-1 filed today (the “Registration Statement”) and the prospectus included therein (the “Prospectus”). For the Staff’s convenience, we have included both a clean copy of the Registration Statement and a copy marked to show all changes from the DRS. Set forth below are the Company’s responses to the Comments. The numbering of the paragraphs below corresponds to the numbering of the Comments, 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. November 8, 2013 Page Two General 1. Please confirm that the graphics included in your registration statement are the only graphics you will use in your prospectus. If those are not the only graphics, please provide any additional graphics prior to their use for our review. Response: The Company acknowledges the Staff’s comment and advises the Staff that the images included in the Registration Statement are all of the graphic, visual or photographic information the Company currently intends to include in the Registration Statement. If the Company decides to use any additional images it will provide the Staff with proofs of such materials as soon as practicable. 2. 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, present to potential investors in reliance on Section 5(d) of the Securities Act, whether or not they retain copies of the communications. Similarly, please supplementally provide us with any research reports about you that are published or distributed in reliance upon Section 2(a)(3) of the Securities Act of 1933 added by Section 105(a) of the Jumpstart Our Business Startups Act by any broker or dealer that is participating or will participate in your offering. Response: The Company acknowledges the Staff’s request. The Company has supplementally provided the Staff written communications presented to potential investors in reliance on Section 5(d) of the Securities Act. The Company advised the Staff that potential investors have not been permitted to retain copies of such written communications. The Company further advises the Staff that to its knowledge, as of the date hereof, no research reports have been distributed by any broker or dealer participating in the offering. The Company intends to supplementally provide the Staff copies of any such materials as promptly as practicable in the event that any additional materials are presented to potential investors pursuant to Section 5(d) of the Securities Act or any materials are distributed by any broker or dealer participating in the offering. Prospectus Summary General 3. We note that your registration statement includes several references to data attributed to IMS Health, Inc. Please briefly describe who IMS Health is. In addition, please disclose what your relationship is to IMS Health and whether the information attributed to IMS Health was compiled on your behalf. Response: In response to the Staff’s comment, the Company has revised the disclosure appearing on pages 1 and 72 of the Registration Statement. As described in the revised disclosure in the Registration Statement, IMS Health is an independent market research firm. According to its website, www.imshealth.com, it is “…the world’s leading information, services and technology company dedicated to making healthcare perform better.” The Company confirms that it has no relationship with IMS Health and no information attributed to IMS Health in the Registration Statement was complied on the Company’s behalf. November 8, 2013 Page Three 4. Please revise your disclosure here and as necessary throughout the prospectus to explain the phrase “peripheral mechanism of action.” Please also explain how “peripherally-active” products are distinguishable from “centrally-active” products and why this is important to the development of CR845. Your discussion should specifically explain how “peripherally-active” kappa opioids, like CR845, avoid both the psychiatric side-effects of “centrally-active” prior kappa opioids and the CNS side effects of mu opioids. Response: In response to the Staff’s comment, the Company has revised the disclosure appearing on pages 1, 55 and 72 of the Registration Statement. 5. Please define or explain your use of the following terms or phrases at their first use in the prospectus: • “short bolus;” • “anti-emetic;” • “NSAIDs;” • “oral bioavailability;” • “pharmacokinetic predictability;” • “somnolence;” and • “transient prolactin elevations;” Response: In response to the Staff’s comment, the Company has revised the disclosure appearing on pages 2, 3, 4, 16, 55, 72, 76, 83 and 88 of the Registration Statement. 6. Please explain the purpose of “rescue medication” as used in your clinical trials. Response: In response to the Staff’s comment, the Company has revised the disclosure appearing on page 3 of the Registration Statement. Our Product Candidates, page 2 7. In the “Status” column of your table, please indicate that I.V. CR845 has completed Phase 2 clinical testing. Response: In response to the Staff’s comment, the Company has revised the disclosure appearing on page 2 and 73 of the Registration Statement. 8. Please define the term “statistically significant.” Response: In response to the Staff’s comment, the Company has revised the disclosure appearing on pages 3 and 77 of the Registration Statement. November 8, 2013 Page Four 9. Please briefly summarize the results of the Phase 1 clinical trial you have completed for Oral CR845. Response: In response to the Staff’s comment, the Company has revised the disclosure appearing on page 4 of the Registration Statement. Risk Factors “If we fail to supply CR845 to our collaboration partners...,” page 13 10. We note your risk factor disclosure that you currently have a single supplier for I.V. CR845 and that failure to provide adequate supply of CR845 product to your co-collaborators could result in a breach of your agreements and potential loss of revenue for the Company. Please identify the single supplier to which you are referring as required under Item 101(h)(4)((v) of Regulation S-K. Please also describe the terms of your current contractual arrangements with this supplier. Response: In response to the Staff’s comment, the Company has revised the disclosure appearing on page 13 of the Registration Statement. “The FDA may determine that I.V. CR845 or any of our other product candidates have undesirable side effects...,” page 16 11. Please revise your risk factor disclosure to identify the specific “poorly tolerated side effects” associated with kappa opioid agonists. Response: In response to the Staff’s comment, the Company has revised the disclosure appearing on page 16 of the Registration Statement. “If the manufacturers upon whom we rely fail to produce our product candidates...,” page 25 12. We note your disclosure that you have developed a formulation of Oral CR845 based on a third party’s proprietary technology but have not yet negotiated terms related to use of such technology for commercial manufacturing. Please revise your disclosure to describe the technology used, indicate how you obtained the rights to use the third party’s proprietary technology for the development of Oral CR845 and identify the party from whom you obtained such technology. Response: In response to the Staff’s comment, the Company has revised the disclosure appearing on page 25 of the Registration Statement. “We will incur increased costs as a result of operating as a public company,” page 38 13. Please include in this risk factor, to the extent practicable, an estimate of the annual costs associated with your reporting obligations. Response: In response to the Staff’s comment, the Company has revised the disclosure appearing on page 39 of the Registration Statement. November 8, 2013 Page Five Special Note Regarding Forward-Looking Statements, page 47 14. We note your statement that “there can be no assurances as to the accuracy or completeness” of information obtained from industry and general publications, studies and surveys. We also note your statement that results and estimates derived from internal research “have not been verified by any independent source.” Please revise your disclosure to remove these statements as it is not appropriate to directly or indirectly disclaim liability for information in the registration statement. Response: In response to the Staff’s comment, the Company has revised the disclosure appearing on page 47 of the Registration Statement. Use of Proceeds, page 48 15. Please separate the amount of net proceeds you intend to use to conduct the Phase 1 clinical trial of Oral CR845 and the amount you intend to use for the Phase 2a clinical trial. Response: In response to the Staff’s comment, the Company has revised the disclosure appearing on page 48 of the Registration Statement. Capitalization, page 50 16. It appears the total capitalization amount presented within the capitalization table represents in substance total liabilities, convertible preferred stock and stockholders’ equity rather than total capitalization. Please revise or advise us. Response: In response to the Staff’s comment, the Company has revised the disclosure appearing on page 49 of the Registration Statement. Selected Financial Data, page 54 17. Please present pro forma earnings per share data in this section consistent with your disclosure on page F-4. Response: In response to the Staff’s comment, the Company has revised the disclosure appearing on page 53 of the Registration Statement. Management’s Discussion and Analysis of Financial Condition and Results of Operations Critical Accounting Policies and Significant Judgments and Estimates Share-Based Compensation, page 67 18. In order for us to fully understand the equity fair market valuations reflected in your financial statements, please include an itemized chronological schedule covering all equity instruments issued since January 1, 2012 through the date of your response. Separately represent to us that you will update this schedule for any appropriate issuances after the date of your response through the date you complete your offering. Please provide the following information separately for each equity instrument issuance: • The date of the transaction; November 8, 2013 Page Six • The number of shares/options issued/granted; • The exercise price or per share amount paid; • Your fair market value per share estimate and how the estimate was made; • The identity of the recipient, indicating if the recipient was a related party; • Nature and terms of concurrent transactions; and • The amount of any compensation or interest expense element. When you have determined the IPO price range, include a reconciliation that progressively bridges your fair market value determinations to the estimated IPO price range. Please reconcile and explain the differences between the mid-point of your estimated offering price range and the fair values included in your analysis. Response: In response to the Staff’s comment, the Company advises the Staff that, since January 1, 2012, aside from the issuance of common stock through the exercise of pre-existing common stock options, the Company has issued equity securities and convertible debt in five separate transactions: Equity Issuances Since January 1, 2012 Junior Preferred Stock Transaction Background On May 15, 2012, the Company issued and sold 173,611 shares of newly designated Junior Preferred Stock to Chong Kun Dang Pharmaceutical Corporation (“CKD”), an unrelated third party, in connection with the entry into a license agreement with CKD, pursuant to which the Company provided CKD with the exclusive rights to develop, manufacture and commercialize products containing CR845, the company’s lead product candidate, in South Korea. Under the agreement, the Company received a non-refundable and non-creditable amount of $1 million and is eligible to receive milestones payments totaling $3,750,000 relating to pre-defined clinical and regulatory events as well as royalties on sales of any marketed products containing CR845. Each share of Junior Preferred Stock is convertible into one share of the Company’s common stock at any time at the option of the holder or upon the occurrence of certain events, including an initial public offering meeting certain specified conditions. The purchase price of the Junior Preferred Stock was included within the $1 million amount noted above. The stated purchase price of the shares of Junior Preferred Stock, pursuant to the license agreement was $2.88 per share. November 8, 2013 Page Seven Fair Value Discussion Notwithstanding the stated purchase price of the shares, the Company estimated the fair market value of the Junior Preferred Stock as of May 15, 2012 to be $2.04 per share ($354,000 in total) based on a contemporaneous, independent third party valuation. Consistent with the American Institute of Certified Public Accountants Practice Aid, Valuation of Privately-Held Company Equity Securities Issued as Compensation (the “Practice Aid”), this valuation was derived using a discounted cash flow methodology to derive the implied value of the Company’s equity, and applying an option-pricing method to derive the value of the Junior Preferred Stock on a controlling, marketable basis and then further applying discounts for lack of control and marketability. The Company has expanded its disclosures on pages 68 and 69 to provide additional detail concerning this valuation. Accounting Discussion As both a license and the sale of Junior Preferred stock were included in this transaction, the Company determined that it represented a multiple element arrangement under ASC 605-25, Revenue Recognition – Multiple Element Arrangements. Regarding elements within an arrangement that are accounted for under topics in which separation and allocation are addressed, ASC 605-25-15-3A states: “If another Topic provides guidance regarding the determination of separate units of accounting and how to allocate arrangement consideration to those separate units of accounting, the arrangement or the deliverables in the arrangement that is within the scope of that Topic shall be accounted for in accordance with the relevant provisions of that Topic rather than the guidance in this Subtopic.” The above refers to Category 1 deliverables that have specific guidance within other topics of the codification. In addition, the Ernst & Young Accounting Manual on Category 1 elements states: Category 1 — Other ASC literature provides guidance on both the separation of multiple deliverables in a multiple