SEC Comment Letter for Propanc Biopharma, Inc. (PPCB) (CIK 0001517681) (PPCB) — Jul 19, 2011
Propanc Biopharma, Inc. (PPCB) (CIK 0001517681)
Date: July 19, 2011 · CIK: 0001517681 · Accession: 0000000000-11-043706
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File numbers found in text: 333-175092
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July 19, 2011 Via E-mail Mr. James Nathanielsz Chief Executive Officer Propanc Health Group Corporation 576 Swan Street Richmond, VIC, 3121, Australia Re: Propanc Health Group Corporation Registration Statement on Form S-1 Filed June 23, 2011 File No. 333-175092 Dear Mr. Nathanielsz: 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. Form S-1 General 1. Please provide us proofs of all graphic, visual, or photographic information you will provide in the printed prospectus prior to its use, for example in a preliminary prospectus. Please note we may have comments regarding these materials. 2. 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 the filing that we have not cited as examples, please make the appropriate changes in accordance with our comments. 3. Please update the discussion in your prospect us to the most recent date practicable. Mr. James Nathanielsz Propanc Health Group Corporation July 19, 2011 Page 2 Cover Page 4. We note the registration statement pertains to a combined primary and secondary offering of common stock, the primary offering will be conducted by the company’s officers and directors, and that these indi viduals are also identified as selling shareholders. Please expand the discussion on the cover page and in the plan distributi on section to clarify whether the primary offering will be comple ted prior to the beginning of the secondary offering. Alternatively, please c onsider providing two separate prospectuses or the filing of alternate pages reflecting the respective offe rings in the next amendment. Regardless of the alternative you select, please identify your affiliates as underwriters. In addition, the prospectus should be updated by filing a post-effective amendment after completion of the primary offering to describe the resu lts of the primary offering. We may have additional comments. 5. Please state whether there is any minimum amount that must be raised as a result of the primary offering, whether there are any mi nimum purchase requirements, and whether there are any arrangements to place the funds in an escrow, trust, or similar account. If you have not made any of these arrangements, st ate this fact and describe the effect on investors. See Item 501(b)(8) of Regulation S-K. Prospectus Summary Our Company, page 1 6. Please include a discussion of the material term s of the exchange offer, the nature of your operations prior to the exchange offer, the approximate percentage ownership the 64.7 million shares represented on the date of the exchange, and the affiliation, if any, between Propanc Pty Ltd. and you prio r to the exchange offer. The Offering, page 2 7. Please expand the presentation to include a lin e item for the number of shares to be offered by the company. 8. Please reconcile the number of shares outstan ding prior to the offering with the number of shares reflected on your financial statem ents and the section en titled “Recent Sales of Unregistered Securities.” We may have additional comments. 9. We note you indicate the number of shares outst anding prior to the offering is the same as the number of shares outstanding immediatel y following the offering which includes up to five million shares on a best efforts basis. Please advise or revise. Mr. James Nathanielsz Propanc Health Group Corporation July 19, 2011 Page 3 Risk Factors – General 10. Please expand the risk factor section to in clude risk factors sp ecifically addressing: Your accountant’s going concern opinion; Potential product liability claims; and The lack of independent di rectors and relate d corporate governa nce issues and potential risks to shareholders. 11. We note you may be substantially dependent upon one or more third parties to conduct your research and clinical studies. If you are, pl ease add a risk factor to address this fact. Also, please file copies of these agreements as exhibits and discuss them in greater detail in your business section. If you do not beli eve that you are substa ntially dependent upon these agreements, please provide an analysis supporting your determination. See Item 601(b)(10)(ii)(B) of Regulation S-K. “Our ability to continue as a going concern…,” page 4 12. Please expand the discussion to quantify the amount of losses you have incurred in each of the past two years and the amount of your accumulated deficit. In addition, please disclose that as of March 31, 2011, you only had $54 in cash. “Because we will need to finance our future cash needs through securities offerings…,” page 4 13. We note your belief that “the net proceeds fr om our prior private equity offerings and existing cash will be sufficient to enable us to fund our projecte d operating requirements for the next twelve (12) months ….” Please reconcile this stat ement with the fact that as of March 31, 2011 your available cash resources apparently consisted of $54 in cash and a receivable for $2608, and the statement at th e bottom of page 14 “therefore, we do not have enough available cash to meet our oblig ations over the next 12 months.” We may have additional comments. “Because pre-clinical and clini cal trials required for our product candidates…,” page 5 14. Please expand the discussion to briefly discu ss whether and the extent to which you have conducted pre-clinical and clinical trials. “If we are unable to obtain sufficient and ade quate supplies necessary for the manufacturing of our product…,” page 6 15. It is unclear from the discussion whether ther e is, in fact, a sole source supplier for the components of your product. If you are s ubstantially dependent on any of your raw material or component suppliers, please identif y them here and identify the products that are materially dependent on the raw materials or components. Also, pl ease file copies of these agreements as exhibits and discuss them in greater detail in your business section. Mr. James Nathanielsz Propanc Health Group Corporation July 19, 2011 Page 4 If you do not believe you ar e substantially dependent upon these agreements, please provide an analysis suppor ting your determination. See Item 601(b)(10)(ii)(B) of Regulation S-K. “If we lose key management or scientific personnel…,” page 8 16. Please expand the discussion to state the extent to which you have employment agreements with your key personnel. If applicable, please file these employment agreements as exhibits. Use of Proceeds, page 11 17. Please revise the disclosure to indicate the or der of priority and th e amount allocated for each specified purpose and discuss your plan s if substantially less than the maximum amount of proceeds is obtained. The disclo sure should quantify the amount to be used for each purpose at different levels of offe ring proceeds. For example, disclose how proceeds will be allocated if 100%, 50%, 25% , and 10% of the total maximum amount of proceeds are received. 18. Please describe what stage of development you expect to achieve for each indication for your product candidates using the proceeds from the offering. 19. We note the discussion under “Liquidity a nd Capital Resources” concerning the $400,000 “down payment toward prospective acquisitions.” We also note the terms of Section 2 of Exhibit 10.7. If proceeds of the offering will be used for acquisitions, the use of proceeds discussion should be expanded accordingly. See also Instruction 6 to Item 504 of Regulation S-K. We may have additional comments. Market for Common Stock, page 12 20. Please expand the discussion to de scribe the criteria that must be satisfied for acceptance of an application for quotat ion on the OTC Bulletin Board. 21. Please expand the discussion to provide the dates of availability and the number of shares that may be sold by affiliat es in accordance with Rule 144. Management’s Discussion and Analysis Results of Operations, page 13 22. You state that the discussion re lates to your subsidiary, Propanc Pty Ltd.. Please revise to discuss the results of operations for the consolidated entity, Propanc Health Group Corporation. Mr. James Nathanielsz Propanc Health Group Corporation July 19, 2011 Page 5 For the Year Ended June 30, 2010 compared to the Year ended June 30, 2009 Revenue, page 13 23. Please expand the discussion to explain th e significance, if any, of your supply of unlicensed medicine to treat patients at the Dove Clinic, incl uding potential legal and liability ramifications, if any. 24. Since Dr. Kenyon is the Medical Director of the Dove Clinic , please tell us why you did not sell the medicine dir ectly to the Dove Clinic. For the Year Ended June 30, 2010 Compared to the Year Ended June 30, 2009 Administration Expense, page 14 25. Please revise your discussion to explain w hy your stock based expense was much higher during the fiscal year ended 2010. Liquidity and Capital Resources, page 14 26. Please tell us whether you are affiliated with Churchill and Associates. We may have additional comments. Business Overview, page 16 27. The overview presentation should be balanced. Since you are in the very early stages of drug development, please temper your positive c onclusions with the fa ct that substantial additional testing will be re quired. The discussion should be expanded to disclose the types of additional tests you will need to conduc t and that early results obtained may not be replicated in later and larger trials. In addition, your positive conclusions should be modified by either expressing them as a hope that additional testi ng will confirm any of the positive results you describe or, a lternatively, delete the conclusions. 28. Please disclose whether your clinical studies we re reported in any scie ntific journals. If so, please identify the jo urnals and state whether the study was subject to peer review. Also, please advise us as to whether any ot her studies of Propanc have been conducted. If so, provide comparative disclosure. 29. Please expand the discussion to describe the general development of the company and its predecessors for at least the past five year s as requested by Item 101 of Regulation S-K. 30. We note you “have engaged leadi ng scientific expert s in the field….” Please provide us with the basis for the statement that these in dividuals are leading e xperts or delete the word “leading.” Mr. James Nathanielsz Propanc Health Group Corporation July 19, 2011 Page 6 31. Please define the term “proenzyme” and briefl y describe the nature of the components of your formula and how it acts as a cancer preventative. 32. Please explain what you mean by the phrase “h as proven to not encounter resistance.” 33. We note the use of the terms “dose” and “tr eatment” in your descri ption of the proposed product. Please clarify whether the terms ar e interchangeable or signify a difference in application or usage. 34. Please expand the discussion to explain why you consider the formulation to be unique. In this regard, we note the original formul ation you tested was developed by third parties and your website refers to Dr. Beard’s 1911 ar ticle concerning the enzyme treatment of cancers. 35. Since your proposed product is designed to treat cancer patients, please expand the discussion to explain what you mean by “high risk” patients as opposed to other patients who may need therapy to prevent their resp ective cancers from returning and spreading. 36. Please expand the discussion relative to the “lea ding scientific experts” you have engaged to: Describe when the expe rts were engaged; Describe the purpose of their engagement; Indentify the experts; and Discuss the extent to which the experts will receive compensation as a result of further development and sale of the proposed product(s). 37. Please identify who provided Drs. Kenyon and Mitchell permission in 2007 to perform clinical trials. 38. We note the “permission” pertained to “a non-commercial supply of proenzyme suppositories.” Please clarify what you mean by this term including whether commercial supplies of proenzyme suppositories are alrea dy available and, if so, for what purposes. 39. Please identify who created “the newly devel oped proenzyme formulation” that was the subject of clinical trial for wh ich permission was received in 2007. 40. We note the reference to Propanc as y our “primary” product. Please expand the discussion to identify your other products and the extent of their development, if any. 41. We note Drs. Kenyon and Mitchell and Mr. Nathanielsz prepared a strategy to commercialize the product after a successful trial. Please expand the discussion to describe the trial including: When and where it was conducted; Who conducted the trial; Mr. James Nathanielsz Propanc Health Group Corporation July 19, 2011 Page 7 The duration of the trial; The trial results; The nature of the control groups; Group sizes; Target indications; Endpoints tested; Results; and P values obtained. 42. Please expand the discussion to specifically de scribe how extensive the research and how limited the clinical trials you conducted were. 43. Please state how many trials you have conducted, the approximate duration of each trial, and the number of patients treated in the resp ective trials. In this regard, we note the registrant was formed in November 2010 and the Australian subsidiary was formed in October 2007. We also note the reference to the fact your directors have worked with researchers over the past 15 years and have enhanced the potency of the treatment. Please expand the discussion to clarify whether and the extent to which your formulation has changed during the course of your clinical trials. 44. Please reconcile the reference on page 16 to your research and development team with the statement on page 21 that you have one employee. 45. We note the reference to the limited trials conducted on 46 patients. Please expand the discussion to: Identify when the trial was conducted and by whom; Describe the duration of the trial; Provide more specific information concerni ng the results of the trial including a breakdown of the details of the patients who “lived significantly longer that initially expected” as well as the patients who died prior to their expected survival time; Discuss whether there was a “control” group among the 46 participants and the nature of any control groups; The size of any groups; Targeted indications; Endpoints tested; Results; P values obtained; and Identify who determined the anticipate d life expectancy used as the trial benchmarks and describe how such life expectancy was calculated. 46. Please tell us the basis for your belief that your treatment will work with a number of different cancer types over a prolonged period. In this regard, we note that half of the Mr. James Nathanielsz Propanc Health Group Corporation July 19, 2011 Page 8 participants in the limited tria l involving your treatment died prematurely. We may have additional comments. 47. If half of the participants in the limited clin ical trial died prematur ely, what is the basis for the statement that Propanc has demonstrat ed minimal side eff ect