SEC Comment Letter for Phio Pharmaceuticals Corp. (PHIO) (CIK 0001533040) (PHIO) — Nov 22, 2011
Phio Pharmaceuticals Corp. (PHIO) (CIK 0001533040)
Date: Nov. 22, 2011 · CIK: 0001533040 · Accession: 0000000000-11-067549
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File numbers found in text: 333-177498
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November 21, 2011 Via E-mail Dr. Mark J. Ahn, Ph.D. President RXi Pharmaceuticals Corporation 60 Prescott Street Worcester, MA 01605 Re: RXi Pharmaceuticals Corporation Form S-1 Filed October 25, 2011 File No. 333-177498 Dear Dr. Ahn: We have reviewed your registration stat ement and have the following comments. In some of our comments, we may ask you to provide us with information so we may better understand your disclosure. Please respond to this letter by am ending your registration statement and providing the requested information. If you do not believe our comments apply to your facts and circumstances or do not believe an amendment is appropriate, please tell us why in your response. After reviewing any amendment to your registration statement and the information you provide in response to th ese comments, we may have additional comments. FORM S-1 General 1. We note that you have submitted a numb er of documents in a confidential treatment request. Please note that you will be receiving comments to the confidential treatment reque st under separate cover a nd that all c onfidential treatment issues must be resolved before we will consider a request for acceleration of the re gistration statement. Dr. Mark J. Ahn RXi Pharmaceuticals Corporation November 21, 2011 Page 2 2. Please provide updated interim financia l statements and related financial information for the period ending September 30, 2011, pursuant to Rule 3-01 and 3-12 of Regulation S-X. Please al so file an updated, signed consent report from your independent audito rs prior to going effective. 3. Please note that before we will declare the registration statement effective, you must revise your filing throughout to include any omitted information that is currently denoted by blanks. 4. Please note that where we provide exampl es to illustrate what we mean by our comments, they are examples and not complete lists. If our comments are applicable to portions of the filings that we have not cited as examples, please make the appropriate changes in accordance with our comments. 5. We note that the tax opini on, legal opinion and related consents have not been filed. Please file them as soon as pract icable, as we will need time to review this exhibits once they have been filed. 6. In several places in the registration statement, you cite various estimates, statistics and other figures. For example: a. The statement that “Approximately 42 million surgical procedures are performed annually…” which is found on pages 1 and 46; and b. The statement that “Numerous studies implicate CTGF overexpression in scarring…” which is found on pages 1 and 46. In the prospectus, please attribute these statements and other similar statements to the source from which you obtained the information. In addition, where you cite your own estimates, pleas e explain how you arrived at those estimates and disclose any thir d-party sources you relied upon. 7. Throughout the registration statement, you should clearly articulate the basis of the various beliefs and assertions you make. As a non-exclusive example, on pages 1 and 35, you state, “We belie ve that RXI-109 or other CTGF- targeting compounds may be able to treat other indications, including pulmonary fibrosis, liver fibrosis, acut e spinal injury, ocular scarring and restenosis.” As another example, on pa ge 49, you state, “The specificity of RNAi may be sufficient to permit th erapeutic targeting…and…may even selectively reduce or eliminate expre ssion…” If you haven’t done so, please clarify whether the relevant statement is your belief or opinion. In addition, please disclose the basis for your belief. If any of your assertions of beliefs are not supported by ample evidence or knowledge, you should delete them. Dr. Mark J. Ahn RXi Pharmaceuticals Corporation November 21, 2011 Page 3 Cover Page 8. You disclose that following the comp letion of the distri bution, you anticipate that your common stock will trade in the OTC Markets Group under the symbol [“RXII.”] Please revise your disclosure he re and on pages 31 and 73 to clarify whether you have filed an app lication for listing. If an application has not been filed, please disclo se when you intend to do so. Table of Contents, page i 9. You state that “We have not independently verified any of this [data derived from third-party sources] and cannot assure you of its accuracy or completeness.” Please delete this statement as it is not appropriate to disclaim or imply that you are not taking liability for the statements in your registration statement. Alternatively, please expand your disclosure to include a statement specifically accepting lia bility for these statements. Prospectus Summary, page 1 10. You disclose on page 42 that you have not generated revenue to date and may not generate product revenue in the foreseeable future, if ever. Furthermore, you expect to incur sign ificant operating losses as you advance your product candidates through the drug development and regulatory process. Please expand your disclosure under “Our Business” to clarify to disclose this information. Risk Factors, page 11 11. On page 57, you note that your research and development activities involve the controlled use of potentially harm ful biological materials as well as hazardous materials, chemicals and va rious radioactive compounds. Please consider whether you should include a risk factor that addresses the resulting risks to you and your business as a result of your use of these materials. “We may be unable to achieve some or all of the benefits that we expect…,” page 11 12. You disclose that you may not be able to obtain approval from one or more granting institutions to Galena’s assi gnment to you of approximately $800,000 of research grants. Please disclose whether you are aw are of any granting institution that has indicate d that it will not consent to the assignment of the respective grant. Dr. Mark J. Ahn RXi Pharmaceuticals Corporation November 21, 2011 Page 4 “We may be unsuccessful in recruiting a Chief Executive Officer…,” page 11 13. You disclosed that you will need to recr uit and hire a Chief Executive Officer to replace Mark J. Ahn, Ph.D., who currently serves as our President and Chief Financial Officer, and other ex ecutive officers and key employees. Please expand your disclosure to list a ll the executive officers you are seeking to recruit and hire. For example, are you also seeking to recruit and hire a Chief Financial Officer? “We will be subject to competition and ma y not be able to compete...,” page 15 14. Please clarify the diseases you are targe ting which are also being targeted by your competitors. “We may be unable to protect our intellectual property rights licensed from other parties…,” page 16 15. Please expand your disclosure to disclose the name of the third party that sent you a letter claiming that you require acce ss to such third party’s patent and patent applications and demanding th at you stop engaging in unspecified alleged infringing activities unless you obt ain a license from such third party as this appears to be information that may be material to your business. “Our success depends upon our ability to obtain and maintain intellectual property protection...,” page 17 16. Please disclose whether there are any other entities which currently have legally blocking proprietary ri ghts of which you are aware. “We will rely upon third parties for the manufa cture of our clinical product.” page 17 17. Please disclose whether there are an y third-party manufacturers upon which you are substantially dependent. Plea se file the related agreements as exhibits to your filing and describe the material terms of any such agreements in your Business section, including, but not limited to any payment provisions, exclusivity provisions, material obliga tions that must be met to keep the agreement in place, duration and termination provisions. “If we fail to attract, hire and re tain qualified personnel...,” page 20 18. To the extent that you have experience d difficulties attracting and retaining key personnel, please revise to discu ss these difficulties. Also, disclose whether any key personnel have plans to retire or leave your company in the near future. Dr. Mark J. Ahn RXi Pharmaceuticals Corporation November 21, 2011 Page 5 “You may have difficulty selling our shares of common stock if they are deemed “penny stocks.” page 22 19. Please clarify whether you believe that your common stock will be deemed a “penny stock.” Plan of Distribution, page 28 Reasons for the Distribution, page 28 20. Please expand this section to describe in more detail the negative factors and potential benefits the Galena board cons idered in evaluati ng the separation of RXi from Galena. 21. Please clarify whether you are responsible for the entire cost of the fees and expenses disclosed on the top of page 29, as we note that you have agreements related to the reimburseme nt of transaction costs as described on page 30. Trading Market, page 31 22. You state on page 32, “These are just so me of the factors that may adversely affect the market price of our common stock.” Please confirm that you have described all material fact ors likely to adversely impact the market price of your common stock or revise the disclo sure to include additional material factors. Trading Between the Record Date and Distribution Date, page 32 23. Please confirm that your record date w ill be after the eff ectiveness of this registration statement. Alternativel y, please provide us with a detailed analysis which supports your conclusion that the “when-issued” trading is consistent with Section 5 of the Securities Act of 1933. Management’s Discussion and Analysis of Fi nancial Condition and Results of Operations Liquidity and Capital Resources, page 42 24. You disclose that you had cash and cas h equivalents of approximately $1.9 million as of October 15, 2011. Please cl arify whether this includes the $1.5 million contribution by Galena wh ich you disclosed on page 30. Dr. Mark J. Ahn RXi Pharmaceuticals Corporation November 21, 2011 Page 6 Business, page 46 25. Please clarify which human diseases or types of human diseases you believe can be potentially treated by silencing ta rgeted genes that lead to disease together with your basis for such belief. Recent Business Developments, page 47 26. In each discussion of the initial results of your preclinical research and data please clarify if there was a specific duration in which the silencing was experienced. In this regard, we notice your reference to one week on page 1. 27. In the third bullet point you note that th e collaboration demonstrated efficacy. Please revise your disclosure to cl arify what you mean by “demonstrated efficacy” as it does not appear to be appr opriate to use this term in reference to a pre-clinical collaboration. Introduction to the Field of RNAi Therapeutics, page 48 28. Please characterize as your belief or opinion the statement that “The specificity of RNAi may be sufficient to permit therapeutic targeting…and…may even selectively reduce or eliminate expression…” Alternatively, provide additional fact ual support for this assertion. Patents and Patent Applications, page 54 29. In this section, you refere nce both patents and patent applications, but you appear to only discuss your material patent applications. Please expand your disclosure in this section to also di scuss any material patents, including for each patent or group of patents the tec hnology to which the patent relates and the expiration date of the patent. 30. Please clarify if you have any patents or patent applications in jurisdictions outside the United States. License Agreements, page 54 31. Please disclose the aggregate milest one payments you are required to pay under the license agreement with the University of Massachusetts Medical School. Dr. Mark J. Ahn RXi Pharmaceuticals Corporation November 21, 2011 Page 7 32. Please disclose the aggregate clinical milestone payments and a range of royalty payments (not to exceed ten per cent) under the license agreement with Dharmacon, Inc. 33. For each of the license agreements below, please provide us with an analysis that supports your conclusion that you ar e not substantially dependent on the following agreements disclosed on page F-28: License agreement with Cold Spring Harbor Laboratory; License agreement with TriLink Biotechnologies; License agreement with Life Technologies; and License agreements with University of Massachusetts Medical School, other than the license agreement already disclosed on page 54. Alternatively, please file th e license agreements as exhibits to your filing and describe the material terms of any su ch agreements in your Business section, including, but not limited to any pa yment provisions, aggregate milestone payments, a range of royalty payments , exclusivity provisions, material obligations that must be met to keep the agreement in place, duration and termination provisions. Management, page 59 34. We note that Mark Ahn also serves as the President, Chief Executive Officer and a director of Galena. Please expa nd your disclosure here and on page 66 to disclose the number of hours Mr. Ahn has agreed to dedicate to you. Please also consider adding a risk factor to discuss the risks that your President and Chief Financial Officer is not working full time for you, is not being compensated by you and may have conflicts of interests with you. Certain Relationships and Relate d Party Transactions, page 65 Agreements with Galena Biopharma, Inc., page 65 35. Here, and in the Business section as a ppropriate, please disclose the names of the institutions which granted the resear ch grants and the license agreements that Galena has assigned to you in connection with the contribution agreement. Advirna Agreement, page 66 36. Please disclose the exact nature of the affiliation between Advirna and Anastasia Khvorova. Dr. Mark J. Ahn RXi Pharmaceuticals Corporation November 21, 2011 Page 8 Beneficial Ownership of Certain Bene ficial Owners and Management, page 68 37. Although we note that there is a “conve rsion cap” limitation for certain of your investors, the security holders’ abili ty to acquire and sell a large amount of your common stock is material in formation which is required to be disclosed in your registration statem ent. See Securities Act Rule 408. Accordingly, please revise your tabl e to include the ownership of Tang Capital Partners, RTW Investments, Mr. Tang and Mr. Wong without consideration of the “conve rsion limitation.” In a ddition, please include a footnote to your beneficial ownershi p table that discloses the “conversion limitation” and the impact on the respective security holders. Exhibits 38. We note that Exhibits 2.1 and 2.2 each omit various schedules and exhibits thereto. Please either file complete c opies of these agreements or provide us with a detailed analysis of each omitte d schedule, exhibit or other attachment thereto that supports your belief th at such schedule does not contain information which is material to an in vestment decision or which is otherwise disclosed in the agreement or the filing and provide us copies of each omitted schedule, exhibit or other attachment th ereto. In addition, please re-file each agreement with a list briefly identifying the contents of all omitted schedules, together with an agreement to furnish supplementally a copy of any omitted schedule to the Commission upon request. See Item 601(b)(2) of Regulation S-K. We urge all persons who are responsible for the accuracy and adequacy of the disclosure in the filing to be certain that the filing includes the information the Securities Act of 1933 and all applicable Securities Act rules require. Sinc