SEC Comment Letter for Cellectar Biosciences, Inc. (CLRB) (CIK 0001279704) (CLRB) — Jul 28, 2011
Cellectar Biosciences, Inc. (CLRB) (CIK 0001279704)
Date: July 28, 2011 · CIK: 0001279704 · Accession: 0000000000-11-045745
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File numbers found in text: 333-175284
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July 27, 2011 Via E-mail Mr. Harry S. Palmin President and Chief Executive Officer Novelos Therapeutics, Inc. One Gateway Center, Suite 504 Newton, MA 02458 Re: Novelos Therapeutics, Inc. Registration Statement on Form S-1 Filed July 1, 2011 File No. 333-175284 Dear Dr. Palmin: We have reviewed your registration statem ent and have the following comments. In some of our comments, we may ask you to provi de us with information so we may better understand your disclosure. Please respond to this letter by amending 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 re gistration statement and the information you provide in response to these comments, we may have additional comments. Registration Statement on Form S-1 General 1. Please note that when you file a pre-eff ective amendment containing pricing-related information, we may have additional comments. As you are likely aware, you must file this amendment prior to circulating the prospectus. 2. Please note that when you file a pre-effectiv e amendment that incl udes your price range, it must be bone fide. We interpret this to mean that your range may not exceed $2 if you price below $20 and 10% if you price above $20. 3. Please note that where we provide examples to illustrate what we mean by our comments, they are examples and not complete lists. If our comments are appli cable to portions of Mr. Harry S. Palmin Novelos Therapeutics, Inc. July 27, 2011 Page 2 the filing that we have not cited as examples, please make the appropriate changes in accordance with our comments. 4. Please provide us supplemental copies of pr oofs of all graphic, visual or photographic information you will provide in the prin ted prospectus prior to its use. 5. Your Form S-1 does not include the financial statements of Novelos, the registrant, for the years ending December 31, 2010 and 2009 and the quarter ending March 31, 2011. Form S-1 rules also require that you include Rule 8-04 financial statements, which as a result of the reverse acquisiti on, will be those of the regist rant, Novelos. Accordingly, please revise to provide the financial statem ents of the acquired company in accordance with Rule 8-04. 6. Please provide the information required by It em 304 of Regulation S-K regarding your change of accountants from Stowe & Degon LLC to Grant Thorton LLP. Prospectus Summary 7. Please briefly define the following term s used in the Prospectus Summary: Radiolabeled; Radioisotope; Apoptosis; Akt; Caspase-mediated; Cytotoxic; Dosimetry. 8. Please note that the Prospectus Summary must be a balanced discussi on of the disclosure found within the Prospectus. Accordingly, it must contain information related to the weaknesses and risks faced by the company in addition to its strengths. Please add a subsection to the Prospectus Summary im mediately following the “Our Business” subsection to briefly describe the major ri sks and weaknesses facing the company. This discussion should include your history of losse s, your involvement in legal proceedings, your need to raise a substant ial amount of funds to continue development of your product candidates, your lack of re venue, and your lack of FDA-approved products. 9. Please briefly describe your material collabo rations and license agreements relating to Cellectar products and technol ogies in this section. 10. Please expand your Prospectus Summary sectio n and Business section briefly to explain how Cellectar developed its technology platform and intellectual property. To the extent that this was developed in-house, please identif y the technology. Mr. Harry S. Palmin Novelos Therapeutics, Inc. July 27, 2011 Page 3 The Offering 11. You state on page 4 that “unl ess we specifically state otherwise, the share information in this prospectus is as of June 29, 2011 . . . .” Please confirm that you will update share information with each amendment as of the latest practicable date. Risk Factors ”We will require additional capital in order to continue our operations . . .,” page 7 12. To the extent possible, please quantify the cost of your currently antic ipated research and development activities, including the costs you will incur prior, and related to, filing INDs for COLD and LIGHT, and costs you will incur related to th e initiation through completion of the Ib trial for HOT. 13. We note your disclosure that your ability to execute your operating plan depends upon your ability to obtain additional funding via the sale of equity and/or debt securities, a strategic transaction, or othe rwise. Please disclose whet her you have approached any sources for additional funding, or have entere d into negotiations for a transaction. 14. We note your disclosure that you may obtai n additional financing by issuing debt securities. Please expand your disclosure to in form the investor that any holders of debt securities could have rights supe rior to existing shareholders. “We were recently a defendant in a securities fraud class ac tion lawsuit . . .,” page 8 15. In the third paragraph of this risk factor, you disclose that the re sulting liability from claims may not be covered by insurance. Pleas e expand this risk fact or to disclose the types of insurance you carry, and the extent of your coverage. “The integration of Novelos and Cellectar may be costly and difficult,” page 9 16. If you have experienced any difficulties in integrating Novelos and Cellectar, please briefly describe them in this risk factor. “We have limited in-house research and manuf acturing capacity and rely . . .,” page 11 17. Please expand this risk factor to discuss the term and termination provisions of any agreements you have with contract manufactur ers, and the University of Wisconsin at Madison. “We may face litigation from third parties who claim . . .,” page 12 18. You state in this risk factor that “most of [your] license agreements would likely require that [you] pay the costs associating with defendi ng this type of litigation.” It is not clear Mr. Harry S. Palmin Novelos Therapeutics, Inc. July 27, 2011 Page 4 if you currently have any license agreements in addition to your license agreement with the University of Michigan. If you do not, please clarify that you are referring to potential future license agreements. If you cu rrently have license agreements in addition to the license agreement with the University of Michigan, th ey should be described in the Business section. 19. If you have or have had any claims against you alleging infringement, please so disclose in this risk factor. “If we are unable to protect or enforce our rights to intellectual property . . .,” page 13 20. You indicate that you maintain confidentiality and assignmen t-of-inventions agreements with your employees and othe r persons with access to your proprietary materials or processes. Please provide the Staff w ith a supplemental copy of the standard confidentiality agreement a nd the assignment-of-inventions agreement you enter into with your employees. We may have further comment. “The use of hazardous materials, including radioactive materials . . .,” page 14 21. Please disclose the amount of your insurance coverage. “If we are unable to convince physicians of the benefits of our intended products. . .,” page 15 22. In this risk factor and in the Business s ection, please describe your target market. “The market for our products is rapidly changing . . .,” page 15 23. Please expand your disclosure in this risk f actor to identify the major potential competing products, their indications, a nd the companies who are selling or developing them. “We depend on key personnel who may terminate their employment . . . ,” page 16 24. To the extent you have experienced problems attracting and retaining highly qualified personnel in the recent past, please re vise to describe these problems. “There may be a limited public market for our securities . . .,” page 17 25. Please briefly describe the listing requirements for initial listing on a registered stock exchange that your common stock currently fails to meet. “Our common stock constitutes a ‘penny stock’ under SEC rules . . .,” page 17 26. Please briefly define a “penny stock.” Mr. Harry S. Palmin Novelos Therapeutics, Inc. July 27, 2011 Page 5 27. In this risk factor, please also discuss the effect on liquidity, specific legal remedies available to investors of pe nny stocks, and how such remedies would affect the company. “If we fail to maintain effective internal co ntrols over financial re porting . . .,” page 17 28. Please disclose any past or present weaknesse s in your internal control over financial reporting. Use of Proceeds 29. The second paragraph of this section, beginning with “We may not be successful in selling any or all of the secu rities offered hereby. . . .” is inappropriate for this filing because this is a firm-commitment offe ring. Please delete this paragraph. 30. We note your disclosure that you expect to use any proceeds received from this offering to fund your research and development activit ies, including the further development of your LIGHT, HOT and COLD compounds in a wide range of cancers. Please expand this statement to disclose where in the pr ocess of developing LIGHT, HOT, and COLD you expect the application of these proceeds will take you. Management’s Discussion and Analysis of Fi nancial Condition and Results of Operations 31. Please revise to provide us the composition of research and development expenses for each period presented. In this regard, please provide us a break-out, if practicable, by development project, development phase (i.e. preclinical versus clinical), or by some other function/nature for which you report these co sts internally. Liquidity and Capital Resources, page 25 32. Please revise to discuss the reasons for the changes in operating assets and liabilities, which contributed to the reduction in cas h used in your opera ting activities from $1,215,612 in the first quarter of 2010 to $324,566 in the first quarter of 2011. For example, you disclose that accounts paya ble and accrued liabili ties contributed $293,000 to operating cash flows in th e first quarter of 2011. Howe ver, you do not discuss the reasons for the corresponding increase in acc ounts payable and accrued liabilities. Ensure that your revised disclosure also describe s any known trends, demands, commitments, events or uncertainties that are reasonably li kely to result in your liquidity increasing or decreasing in any material way. Critical Accounting Policies Stock-based Compensation, page 26 33. In order for us to fully unde rstand the equity fair market valuations reflected in your financial statements, please re vise to provide a table disclo sing the number of instruments Mr. Harry S. Palmin Novelos Therapeutics, Inc. July 27, 2011 Page 6 granted, exercise price, fair value of the unde rlying stock, fair value of the instrument granted for all equity instru ments and the amount of compensation or interest element recorded, if any, for all equity instrument s issued during 2010 and 2011 through the date of your response. This table should include the 3,576,400 options issued on May 18, 2011 for $1.40. 34. We may have additional comments on your accounting for stock compensation and related disclosure once you have disclosed an estimated offering price. Once you have disclosed an estimated offering price, please provide quantita tive and qualitative disclosures explaining the difference between the estimated offering price and the fair value of each equity issuance. Business Business of Novelos, page 27 35. Please clarify in the discussion of LIGHT on page 28 whether an IND has been filed for LIGHT. Pipeline Product, page 32 36. You suspended development of NOV-002 and NOV-205, pending further revaluation, but continue to describe these compounds as “Legacy Pipeline Products.” Please revise your disclosure to clarify the current stat us of these drug compounds, previously under development by Novelos, and describe the reasonably likely prospects for their continuing future development. Manufacturing, page 33 37. You state that LIGHT is curre ntly manufactured by your colla borator, the University of Wisconsin, and that you currently rely upon contract manufacturers to produce COLD. Please disclose whether you have any other ag reements related to the manufacture of COLD. If so, please describe the material terms of these agreements, including each parties’ rights and obligati ons under the agreement, durati on, termination provisions and all other material terms. Please also file a ny agreements as exhibits to your registration statement, or provide a legal analysis as to why these agreements need not be filed pursuant to Item 601(b)(10) of Regulation S-K. Competition, page 33 38. Please expand your disclosure to identify th e companies that produce Zevalin, Bexxar, and FDG. Mr. Harry S. Palmin Novelos Therapeutics, Inc. July 27, 2011 Page 7 Licenses / Collaborations, page 35 39. Please expand your description of the license ag reement between Cellectar and the University of Michigan to describe: All of Cellectar’s obliga tions and related deadlin es under the agreement; The status regarding these obligations; The consequences of a failure to perform; and Any termination provisions in the license agreement. Compensation of Directors and Executive Officers Employment Agreements, page 43 40. You state that on June 1, 2011, the employment agreement between the company and Mr. Palmin was amended. Please file the amende d employment agreement as an exhibit to your registration statement pursuant to Item 601(b)(10) of Regulation S-K. Security Ownership of Certain Beneficial Owners and Management 41. It appears that the total numb er of shares beneficially ow ned by Greenway Properties Inc. is miscalculated. It appears that the number should be 2,337 ,400 instead of 1,337,400. Please revise accordingly. 42. In the footnotes to this table, please iden tify the natural person( s) who ultimately hold dispositive and voting power ove r the shares held of reco rd by MEG-Cellectar II LLC and Greenway Properties Inc. Management 43. It appears that you have a clas sified board of directors. In the table on page 39, please specify the year in which each director’s term will expire. Notes to Financial Statements 5. Convertible Debt, page F-12 44. Regarding the convertible notes issued on January 25, 2010, please explain the following: a. How you calculated the initial beneficial conversion feature of $214,000 that was recognized immediately, specifically addr essing the fair value of Cellectar’s common stock at the date of grant and th e number of shares the convertible notes were convertible into; b. Tell us how you determined at January 20, 2011 that the Convertible Notes would be converted into 4,181,535 shares of comm on stock and how you calculated the Mr. Harry S. Palmin Novelos Therapeutics, Inc. July 27, 2011 Page 8 additional shares of 343,963 compared to the original terms of th e convertible notes; and c. Explain how you calculated the additi onal interest expense of $258,000 in connection with the January 2011 convers ion and your basis for recognizing the expense in the second quarter of 2011 ra ther than the first quarter of 2011. 4. License Agreements, page F-11 45. Please disclose the current status and ke y terms governing Nove los’ collaboration agreements with Lee’s Pharmaceutical and Mundipharma that govern NOV-002 and NOV-205 and how these agreements may impact the combined company going forward. In this regard, we note in Novelos’ Fo rm 10-K