SEC Comment Letter for CardioVascular BioTherapeutics, Inc. (CIK 0001303497) — Oct 26, 2004
CardioVascular BioTherapeutics, Inc. (CIK 0001303497)
Date: Oct. 26, 2004 · CIK: 0001303497 · Accession: 0000000000-04-034396
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File numbers found in text: 333-119199
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<DOCUMENT> <TYPE>LETTER <SEQUENCE>1 <FILENAME>filename1.txt <TEXT> Mail Stop 3-09 October 20, 2004 Daniel C. Montano Chief Executive Officer CardioVascular BioTherapeutics, Inc. 1700 West Horizon Ridge Parkway, Suite 100 Henderson, Nevada 89012 Re: CardioVascular BioTherapeutics, Inc. Registration Statement on Form S-1 File Number 333-119199 Dear Mr. Montano: We have reviewed your filing and have the following comments. Where indicated, we think you should revise your document in response to these comments. If you disagree, we will consider your explanation as to why our comment is inapplicable or a revision is unnecessary. Please be as detailed as necessary in your explanation. In some of our comments, we may ask you to provide us with supplemental information so we may better understand your disclosure. After reviewing this information, we may or may not raise additional comments. Please understand that the purpose of our review process is to assist you in your compliance with the applicable disclosure requirements and to enhance the overall disclosure in your filing. We look forward to working with you in these respects. We welcome any questions you may have about our comments or on any other aspect of our review. Feel free to call us at the telephone numbers listed at the end of this letter. FORM S-1 General 1. We note that you made a Regulation D filing on October 14, 2004. Please provide us with a legal analysis supporting your determination that the offering is not required to be integrated with this offering. 2. We note you plan to price your stock at $10 per share. We also note the amount registered in the registration fee table appears to be based on a share price greater than $10. Please explain why the proposed maximum aggregate offering price and registration fee are not based on $10. Additionally, given that you have set the offering price at $10, please complete the tables on the cover page and on page 61. We may have further comments if you revise your offering price. 3. We note your references to "Phase I/II" clinical trials throughout your filing. Please confirm that your Phase I/II trials are designed to meet all of the requirements of Phase II clinical trials. Specifically, we note that phase II trials typically involve administering the product under development to 100-300 participants and allow for the evaluation of the effectiveness of the drug and determine the short-term side effects and risks. Has the FDA agreed that your study is designed to meet the requirements of Phase II trials? If your study is not designed to meet all requirements of FDA approved Phase II clinical trials, then please delete the references to "Phase I/II" and replace the references with the term "Phase I" and explain that the trials are designated to provide information related to the effectiveness of your product candidate. 4. Please explain to us the methodologies being followed that you believe justify characterizing the trials as "Phase I/II." Which components of a Phase II trial are included? 5. Additionally, clarify whether the FDA reviewed the earlier trials conducted by Dr. Stegmann to determine the metabolism, pharmacologic effects and side effects associated with increasing doses. Prospectus Inside Front Cover Page 6. Please remove the graphics on both the front and back inside front cover pages from your filing. The technology and level of detail in these images could cause investors to assume that your product has been approved and is already in use. If you plan to include any other graphics in your filing, please provide us proofs of them. Table of Contents page 7. Please relocate the paragraph after the table of contents so it appears somewhere after the risk factors. It is not required by Item 502 of Regulation S-K. Prospectus Summary, page 1 8. Your Summary discusses only the positive aspects of your business, product, prospects, and strategy. We further note that much of it focuses on your plans for Cardio Vascu-Grow, which is only in Phase I/II trials. Please balance the disclosure by discussing the difficulties your company faces and the hurdles you must overcome to achieve each of the strategy objectives listed. You should include, among other things, the fact that you have never earned any revenues and do not expect to become profitable for at least the next several years, the amount of your accumulated deficit, and the fact that only a small number of research and development programs ultimately result in commercially successful drugs (as stated in a risk factor on page 6). 9. Our understanding is that although the terms "cardiovascular disease" and "coronary artery disease" are sometimes used interchangeably, "cardiovascular disease" is technically a general description for several specific heart-related diseases, one of which is coronary artery disease. * Unless you believe Cardio Vascu-Grow can potentially treat all cardiovascular diseases, you should revise the first sentence in the "Our Business" discussion and the entire "Our Target Market" discussion to refer only to the specific diseases you believe it can treat. * You should also make it clearer in your Summary that the current Phase I/II trials address only coronary artery disease. * We note the $170 billion figure mentioned in the "Our Target Market" discussion applies to "hospital costs, medical professional services and drug costs to treat cardiovascular disease." Please (a) replace this figure with a figure representing the market for only the specific diseases you believe your product can potentially treat, (b) include only the "drug costs" portion of the market size since your product is a drug, and (c) state the market size for drugs treating coronary artery disease, which is the indication targeted by the current Phase I/II trials. Cite your sources for all of this information. 10. Please remove the discussion of the clinical trials in Germany from your Summary. Discussions of results from preliminary trials should be reserved for the Business section, where the results can be placed in context. In that regard, where you discuss these trials on page 33, please provide measurements for the control group as compared to the group actually receiving the medication, and disclose what statistical analysis was performed and the degree of statistical significance found as measured by the p-values obtained. Provide this information for each finding you mention. Summary Financial Data, page 4 11. Please disclose the reasoning for presenting the pro forma basic and diluted loss per common share amounts and the adjustments made to arrive at the amounts. This comment also applies to Selected Financial Data on page 23. Risk Factors 12. If any participants in your clinical trials or the clinical trials conducted by Dr. Stegmann experienced any adverse side effects, please include a separate risk factor disclosing all adverse side effects. We have a history of losses and expect to incur substantial losses ..., page 5 13. We note your statement that you believe your cash, cash equivalents and proceeds from this offering will be sufficient to last through the end of 2006. Please state whether this statement assumes the notes are converted to common stock. If it assumes the notes are converted to common stock, please indicate how long your cash, cash equivalents and proceeds are expected to last if the notes are not converted to common stock. If we continue to incur operating losses for a period . . . , page 5 14. Please divide this risk factor into two risk factors: one addressing the consequences of not obtaining sufficient capital and the other addressing the negative consequences of obtaining capital, such as dilution. It may be appropriate to combine the second risk factor with "New investors will experience immediate and substantial dilution . . ." on page 15. If we have to pay off our convertible notes . . . , page 6 15. Please disclose the amount of accrued and unpaid interest on the notes as of the most recent practicable date. To the extent you are able, update this amount with each amendment to your filing during the course of our review. We may not receive regulatory approvals for Cardio Vascu-Grow, page 6 16. Please discuss your dependence on independent clinical investigators in a new, separate risk factor. If you are substantially dependent on any one investigator or on a small number of investigators, you should (a) identify the investigator(s), (b) file any written agreement you have with them, and (c) discuss the material terms of the agreement in your Business section. 17. Also, if you have actually experienced any of the difficulties you describe in this risk factor, please discuss the situation. If we are unable to retain and recruit qualified scientists . . . , page 7 18. This risk factor, the risk factor that follows it, and the risk factor entitled "We have no marketing experience . . ." on page 9 seem to overlap. Please consolidate these risk factors, or revise them so it is clear they are addressing distinct risks. 19. Identify all employees you consider to be key. 20. We note your statement on page 38 that you have eight scientists under month-to-month contract and your statement on page 43 that you have a total of five employees. Are your scientists considered consultants? Are there any risks associated with their status as consultants? For example, do they devote all of their time to development activities related to your product candidate? Is there any risk that they may become unavailable or may go work for a competitor? If we are unable to recruit and retain key personnel . . . , page 7 21. If you have experienced problems recruiting or retaining personnel, please revise to discuss the problems you have experienced. If there are any factors relating to your industry or your company that make recruiting or retaining employees particularly difficult, please revise to discuss these factors. Prior activities of our Chief Executive Officer . . . , page 7 22. If Mr. Montano`s past has actually caused material harm to your business, for example by impeding your ability to form a needed business relationship, please discuss the situation. 23. Please disclose that Mr. Montano was subject to a cease and desist order and explain the consequences. Similarly, revise the discussion of Mr. Montano`s previous experience in the "Management" section. 24. Quantify the percentage of the voting that Mr. Montano controls. Or principal executive officers, including our Chief Executive Officer . . . , page 8 25. Please revise to state that the officers may not have sufficient time to devout to your operations and any other potential consequences. Our relationship with Phage Biotechnology Corporation . . . , page 8 26. If the conflicts of interest discussed in this risk factor have materialized and caused harm to your business in the past, please discuss the situation. Also, disclose in the "Prospectus Summary" section the issues related to conflicts of interest. 27. Identify your officers and directors that hold voting control of 41.20% of Phage. Have these officers and directors entered into any voting agreements that require them to vote together? If they have, please include a discussion of these agreements. We do not have manufacturing capability . . . , page 9 28. Please disclose when your supply agreement with Phage expires. Also, if Phage can terminate the agreement at will, disclose that fact. We may encounter delays or difficulties in our Cardio Vascu-Grow . . . , page 10 29. Please move this risk factor so that it follows "We may not receive regulatory approvals for Cardio Vascu-Grow," which begins on page 6. As these two risk factors overlap somewhat, please eliminate any duplicative disclosure. Cardio Vascu-Grow is our only drug product, page 11 30. Please move this risk factor so that it follows "If we have to pay off our convertible notes after this offering . . ." on page 6. Also, please consider combining this risk factor with "Because the development of Cardio Vascu-Grow . . ." on page 6. If we fail to adequately protect our intellectual property rights ..., page 11 31. If you are aware of any parties infringing on your patents or if you are aware of any claims that you are infringing on the patents held by third parties, please revise to disclose this information. Competition and technological change may make . . . , page 13 32. Please identify your principal competitors and the products that will compete with yours. State which phase of clinical development the competing products are in, or if they are already approved, so state. Even if we receive FDA approval to market Cardio Vascu-Grow . . . , page 13 33. Please combine this risk factor with "If physicians and patients do not accept products for which we obtain marketing approval . . ." on page 10. Our principal stockholders have significant voting power . . . , page 14 34. We note your statement that these stockholders plan to act together. Have these parties signed a voting agreement? If they have, please file the agreement as an exhibit to the registration statement and disclose this information in the registration statement. Anti-takeover provisions in Delaware law could discourage a takeover, page 15 35. Please revise this risk factor heading and discussion to disclose that an additional consequence to investors is that the anti-takeover provisions may prevent or frustrate any attempt by shareholders to change the direction or management of the company. New investors will experience immediate and substantial dilution . . . , page 15 36. Please revise this risk factor to explain that investors who purchase shares will: * Pay a price per share that substantially exceeds the value of your assets after subtracting its liabilities; and * Contribute ___% of the total amount to fund the company but will own only ___% of the outstanding share capital and ___% of the voting rights. In selling our convertible notes, we may have violated . . . , page 15 37. Please briefly disclose why your counsel believes the availability of exemptions cannot be determined with legal certainty, and disclose your total potential liability if the securities sales were to be rescinded. This is First Dunbar Securities` first initial public offering . . . , page 16 38. We note that "First Dunbar`s limited experience may adversely affect the pricing of the offering and the liquidity of the common stock." Please revise this sentence so it more clearly explains the risk to investors. For example, are you saying the offering price might be too high, in which case it will be difficult for investors to earn a gain on the stock? How will First Dunbar`s limited experience affect the stock`s liquidity? Also, revise the heading for this risk factor so that it clearly identifies the risk being described. Use of Proceeds, page 18 39. Please revise your use of proceeds discussion to include a dollar amount that you intend to allocate to each of the uses identified. 40. We note that you intend to allocate 61% of the proceeds for the on-going clinical trial. Please clarify if this is just the Phase I/II trial you discuss throughout your documents or if it includes the Phase III clinical trials you will perform after completion of the currently ongoing trial. Your discussion should identify what phases you anticipate you will be able to complete with the expected proceeds. 41. Please more specifically identify the research and development studies you expect to perform with these proceeds. For example, are you referring to the preclinical animal studies discussed on page 2? 42. We note your statement on page 24 that you expect to incur additional research and development expenses of approximately $13 million to $15 million relating to Cardio Vascu-G