SEC Company Response from Viking Therapeutics, Inc. (VKTX) (CIK 0001607678) (VKTX) — Jul 1, 2014
Viking Therapeutics, Inc. (VKTX) (CIK 0001607678)
Date: July 1, 2014 · CIK: 0001607678 · Accession: 0001193125-14-257887
AI Filing Summary & Sentiment
Referenced dates: June 18, 2014
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CORRESP 1 filename1.htm Correspondence 1(650) 320-1804 jeffhartlin@paulhastings.com 79891.00002 July 1, 2014 VIA EDGAR AND OVERNIGHT DELIVERY U.S. Securities and Exchange Commission Division of Corporation Finance 100 F Street, N.E. Washington, DC 20549 Attention: Johnny Gharib, Esq. Bryan J. Pitko, Esq. Jeffrey P. Riedler, Esq. Keira Nakada Mary Mast Re: Viking Therapeutics, Inc. Draft Registration Statement on Form S-1 Submitted May 22, 2014 CIK No. 0001607678 Ladies and Gentlemen: On behalf of Viking Therapeutics, Inc., a Delaware corporation (the “Company”), we submit this letter in response to comments from the staff of the Securities and Exchange Commission (the “Commission”) received by letter from the staff of the Commission (the “Staff”) dated June 18, 2014, relating to the Company’s draft Registration Statement on Form S-1 confidentially submitted to the Commission via EDGAR on May 22, 2014 (the “DRS”). On behalf of the Company, we confirm to you that as of the date of this letter the Company continues to be an emerging growth company, as defined in Section 2(a)(19) of the Securities Act of 1933, as amended (the “Securities Act”). The Company is concurrently filing via EDGAR a Registration Statement on Form S-1 (the “Registration Statement”). The Registration Statement has been revised to reflect the Company’s responses to the comment letter to the DRS received from the Staff on June 18, 2014. For the convenience of the Staff, we are providing by overnight delivery a courtesy package that includes three copies of this letter and three copies of the Registration Statement marked to show the changes from the DRS that was submitted confidentially on May 22, 2014. In this letter we have recited the comments from the Staff in italicized, bold type and have followed each comment with the Company’s response thereto. Paul Hastings LLP | 1117 S. California Avenue | Palo Alto, California 94304 t: +1.650.320.1800 | www.paulhastings.com U.S. Securities and Exchange Commission July 1, 2014 Page 2 General 1. We note that there are a number of additional exhibits that still need to be filed. Please provide these exhibits as promptly as possible. Please note that we may have comments on these materials once they are provided. The Company has filed with the Registration Statement all of the exhibits other than Exhibits 1.1 and 5.1. The Company advises the Staff that Exhibits 1.1 and 5.1 are still being finalized and will be filed with a subsequent amendment to the Registration Statement. The Company acknowledges the Staff’s note that the Staff may have comments on any materials filed as an exhibit to the Registration Statement, and will endeavor to file the remaining exhibits with a subsequent amendment to the Registration Statement as promptly as possible following finalization of the documents. The Company advises the Staff that pursuant to a letter submitted to the Commission under separate cover on the date hereof, the Company is requesting confidential treatment of certain provisions contained in Exhibits 10.12, 10.13 and 10.21 filed with the Registration Statement. 2. 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. The Company hereby confirms that the graphics included in the Registration Statement are the only graphics the Company will use in its prospectus. 3. 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. In response to the Staff’s comment, the Company is supplementally providing to the Staff under separate cover written communications that were presented to potential investors in reliance on Section 5(d) of the Securities Act. The Company advises the Staff that potential investors have not been permitted to retain copies of such written communications and that the written communications were not sent electronically to potential investors. In the event the Company uses additional materials in reliance on Section 5(d) of the Securities Act, the Company will supplementally provide the Staff with copies of such materials as promptly as possible. The Company also advises the Staff that, based upon information received by the Company from the underwriters identified in the Registration Statement, no research reports about the Company have been published or distributed in reliance on Section 2(a)(3) of the Securities Act by any broker or dealer that is a participant in the offering. The Company will supplementally provide to the Staff research reports, if any, that are published or distributed in reliance upon Section 2(a)(3) of the Securities Act or Section 105(a) of the JOBS Act if the Company becomes aware that any reports are published or distributed. U.S. Securities and Exchange Commission July 1, 2014 Page 3 Prospectus Summary, page 1 4. Where the following terms first appear in the Prospectus Summary, please give the meaning and significance of such terms in plain language that may be understood by a lay reader not acquainted with the relevant industry or scientific field: • selective androgen receptor modulator; • metformin; • renally-impaired; • clinically significant, and • statistically significant. In response to the Staff’s comment, the Company has revised the disclosure on pages 2, 72 and 74 of the Registration Statement to include disclosure regarding the meaning and significance of the terms “selective androgen receptor modulator”, “metformin”, “renally-impaired”, “clinically significant” and “statistically significant”, in each case in the first instance where the term is used in the Registration Statement. The Company VK0612 for Type 2 Diabetes, page 1 5. We note your disclosure in the third bullet point in this section, which states that VK0612 has been well-tolerated at and above doses that you plan to administer in your Phase 2b clinical trial. Please expand your disclosure to disclose the doses that you plan to administer in your Phase 2b clinical trial. In response to the Staff’s comment, the Company has revised the disclosure on pages 2, 71 and 83 of the Registration Statement to include the doses that the Company plans to administer in its Phase 2b clinical trial for VK0612. 6. Please describe the purpose of your end-of-Phase 2 meeting with the FDA and how such meeting impacts your planned regulatory development of VK0612. In response to the Staff’s comment, the Company has described the purpose of the end-of-Phase 2 meeting with the FDA and how such meeting impacts the Company’s planned regulatory development of VK0612 on page 72 of the Registration Statement, the first instance where the end-of-Phase 2 meeting is mentioned in the Registration Statement. U.S. Securities and Exchange Commission July 1, 2014 Page 4 Risks Related to Our Business, page 4 7. Please revise your risk factor discussion in this section to note that you have received an opinion from your independent registered public accounting firm that expresses substantial doubt about your ability to continue as a going concern. In response to the Staff’s comment, the Company has revised the disclosure on page 5 of the Registration Statement to include a reference to the going concern risk. Agreements with Ligand, page 5 8. We note your disclosure at page 90 that pursuant to the Master License Agreement, you will issue common stock having an aggregate value of $29 million to Ligand at the closing of your initial public offering. Please revise your disclosure to include this information in each location in which you make reference to the upfront fee payable to Ligand in equity under the terms of the Master License Agreement. In response to the Staff’s comment, the Company has revised the disclosure on pages 5, 73 and 136 of the Registration Statement to include disclosure to the effect that the upfront fee payable to Ligand in equity has a value of $29.0 million and will be issued at the closing of the Company’s initial public offering. Risk Factors 9. We note your disclosure on page F-15 which states that as of December 31, 2013 you had federal and state net operating loss carryforwards of approximately $158,000 and $158,000, respectively. Please add an appropriately titled risk factor discussing your ability to use your net operating loss carryforwards. In doing so, please quantify the amount of your net operating loss carryforwards in the risk factor, disclose when they will begin to expire and describe any annual limitations on the use of the carryforwards. In response to the Staff’s comment, the Company has added a risk factor on page 44 of the Registration Statement regarding the use, quantity, expiration and limitations of its net operating loss carryforwards. Risks Related to Our Business Our drug candidates may cause undesirable side effect…, page 15 10. Please identify the party responsible for the drug development program of the small molecule inhibitor CD-917. In response to the Staff’s comment, the Company has revised the disclosure on pages 15, 81 and 82 of the Registration Statement to note that Sankyo Company, Ltd., now Daiichi Sankyo Company, Ltd., was responsible for funding and conducting the clinical development program for CS-917. U.S. Securities and Exchange Commission July 1, 2014 Page 5 Our employment agreements with our executive officers may require us…, page 30 11. Please identify the executive officers with employment agreements containing change in control and severance provisions in this risk factor. In response to the Staff’s comment, the Company has revised the disclosure on page 30 of the Registration Statement to clarify that the employment agreements with each of the Company’s executive officers contain change in control and severance provisions. Risks Related to Our Intellectual Property If we fail to comply with our obligations in the agreements under which…, page 31 12. Please expand your risk factor disclosure to summarize the various circumstances in which Ligand may be permitted to terminate the Master License Agreement. In response to the Staff’s comment, the Company has revised the disclosure on page 31 of the Registration Statement to include a summary of the circumstances in which Ligand may be permitted to terminate the Master License Agreement. Changes in U.S. patent law could diminish the value of patents in general,…, page 35 13. Please identify and describe the recently enacted patent reform legislation and legislation currently being implemented which you reference in your risk factor discussion. In this regard, please discuss any impact such legislation will have your patent rights. In response to the Staff’s comment, the Company has revised the disclosure on page 36 of the Registration Statement to more fully discuss recently enacted patent reform legislation, legislation currently being implemented and the potential impact of such legislation on the Company’s patent rights. We may not be able to protect our intellectual property rights throughout the…, page 36 14. We note your statements that the legal systems of certain countries do not favor the enforcement of patents and other intellectual property protection, particularly those relating to biopharmaceuticals and that the laws of some foreign countries do not protect proprietary rights to the same extent or in the same manner as the laws of the U.S. Please disclose which countries you are referencing and whether you have any licensed patents or patent application pending in such countries. The Company acknowledges the Staff’s comment and has revised the disclosure on pages 36 and 37 of the Registration Statement to disclose the countries the Company is referencing, as well as the Company’s licensed patents and patent applications pending in such countries. U.S. Securities and Exchange Commission July 1, 2014 Page 6 Use of Proceeds, page 49 15. We note your statement that you cannot predict the stage of development you expect to achieve in clinical trials and preclinical trials for your product candidates using proceeds from the offering. While we understand the inherent uncertainty with respect to the development of product candidates, where you have identified specific purposes for which you intend to use the offering proceeds, investors are entitled to your best estimate as to how far such proceeds will allow you to proceed towards the achievement of the specified purposes. As such, please revise your disclosure to provide an estimate as to how far in the planned clinical trials of VK0612 and VK5211, and the development of your three preclinical drug candidates the offering proceeds will enable you to reach. You may, as necessary, provide additional disclosure that advises investors of the particular factors and assumptions that form the basis of your estimate, any uncertainty surrounding your estimate and the reasons that the actual results could vary. In response to the Staff’s comment, the Company has revised the disclosure on page 49 of the Registration Statement to note the stage of development the Company expects to reach with each of its drug candidates using the estimated net proceeds from the offering. Management’s Discussion and Analysis of Financial Condition and Results of Operations Critical Accounting Policies Convertible Notes Payable and Related Debt Conversion Feature Liability, page 61 16. Please expand your disclosure to provide the amount of interest payable on the convertible notes as of March 31, 2014. In response to the Staff’s comment, the Company has revised the disclosure on page 62 of the Registration Statement to disclose the amount of accrued interest payable on the convertible notes as of March 31, 2014. Common Stock Fair Value, page 62 17. We may have additional comments on your accounting for stock compensation or any beneficial conversion features once you have disclosed an estimated offering price. Please supplementally provide us with a quantitative and qualitative analysis explaining the difference between the estimated offering price and the fair value of each equity issuance through the date of effectiveness for the preceding twelve months. The Company acknowledges the Staff’s comment and notes that the Company has disclosed under “Management’s Discussion and Analysis of Financial Condition and Results of Operations—Critical Accounting Policies and Estimates—Stock-Based Compensation” on page 63 of the Registration Statement all of its stock issuances since the Company’s inception on September 26, 2012. The Company will supplement this disclosure in the event it issues additional stock-based compensation prior to the date of effectiveness. U.S. Securities and Exchange Commission July 1, 2014 Page 7 The Company’s board of directors had determined at the time that each share of the Company’s common stock issued on September 26, 2012, April 15, 2013, July 15, 2013 and February 20, 2014 had a deemed fair value of $0.01 per share. In connection with the preparation of the financial statements necessary for inclusion in the Registration Statement, in 2014 the Company reassessed the estimated fair value of its common stock at