SEC Comment Letter for VIREXX MEDICAL CORP (CIK 0001275011) — Sep 9, 2005
VIREXX MEDICAL CORP (CIK 0001275011)
Date: Sept. 9, 2005 · CIK: 0001275011 · Accession: 0000000000-05-046710
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<DOCUMENT> <TYPE>LETTER <SEQUENCE>1 <FILENAME>filename1.txt <TEXT> Via Facsimile and U.S. Mail Mail Stop 6010 September 8, 2005 Antoine A. Noujaim Chairman, Chief Executive Officer and Director ViRexx Medical Corp. 8223 Roper Road Edmonton, Alberta T6E 6S4 Canada Re: ViRexx Medical Corp. Registration Statement on Form 20-F Filed August 12, 2005 File No. 1-32608 Dear Mr. Noujaim 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 information so we may better understand your disclosure. After reviewing this information, we may 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 any other aspect of our review. Feel free to call us at the telephone numbers listed at the end of this letter. FORM 20-F General 1. In your response letter, please state our comment and then explain each change that has been made in response to a comment. In addition, you should also reference each page number in which disclosure has been revised in response to a comment so that we can easily place your revised disclosure in its proper context. 2. Please update your financial statements as of and for the period ended June 30, 2005. You should also update all of the disclosure throughout your filing as of June 30, 2005, the dates specified by the various respective items of Form 20-F or a more recent date, as required. We may have further comments upon reviewing your updated disclosure. 3. In light of the fact that none of your product candidates have received regulatory approval, you should not call them products, but rather refer to them as "potential products" or "product candidates" throughout the filing. For product candidates for which you have completed at least some clinical trials, in each and every instance you describe any of those product candidates as effective or having achieved certain results, you should state that these results are clinical and that the product candidate has not received regulatory approval. For product candidates for which you have not completed any clinical trials, in such instances you should state that fact, and not make any statements about the effectiveness or efficacy of those product candidates. Please make these changes throughout the document. We expect this comment to impact your disclosure on several pages throughout the document, and may have further comments once you have significantly tempered your disclosure throughout in your next amendment. Forward Looking Information, page 5 4. Section 21E(a) of the Securities Exchange Act provides that the safe harbor for forward-looking statements does not apply to non- reporting companies. Please note that a company that is not subject to the reporting requirements of Section 13(a) or 15(d) of the Securities Exchange Act of 1934 at the time a forward-looking statement is made cannot avail itself of the protections of Section 27A of the Securities Act of 1933 or Section 21E of the Securities Exchange Act of 1934. As such, please revise this section to delete your references to that Act or state that the safe harbor does not apply to your forward-looking statements. Glossary of Terms, page 6 5. Please delete the glossary from your filing and define each of the terms contained in the glossary in the body of the filing the first time it is used in the text. A. Selected financial data, page 10 6. Please state which data are derived from audited financial statements and which are not. Also, as to the interim period data, provide comparative data from the same interim period of 2004. See Item 3.A.1. of Form 20-F. 7. Please provide Selected Financial Data for the five most recent financial years as required by Item 3.A of Form 20-F. B. Capitalization and indebtedness United States dollar convertible debenture, page 1 8. Please revise to state whether the principal and unpaid interest on the debenture issued by AltaRex was paid on August 23, 2005, and update the disclosure to reflect any other material changes regarding the debenture, any conversions, etc. Canadian dollar convertible debentures, page 14 9. Please quantify the conversion price. Disclose how many shares of common stock you issued when the holder converted $235,000 of these debentures. Risk Factors, page 14 General 10. Please revise to group your related risk factors together under classified headings such as risks related to your industry and risks related to your company. 11. The introductory paragraph suggests that you have not discussed all material risks known to you. You must disclose all risks that you believe are material. In this regard, please revise this paragraph to remove the first sentence, as this statement may appear to be a disclaimer of responsibility for the risk factors. As to the second sentence, in which you list other risks besides those articulated in the actual risk factors, delete the sentence and revise the risk factors to discuss all material risks. Additionally, please revise this introductory paragraph to indicate that you have disclosed all material risks in the risk factors section. 12. Many of your risk factor subheadings merely identify concepts or conditions without explaining how they relate to the company or how and why they pose potential risks to the shareholders. As a non- exclusive example, your risk factor entitled, "The corporation relies on patents and proprietary rights to protect its technology," does not identify any risks and only communicates that you rely upon patents and other rights to protect at least some of your intellectual property. Please briefly expand each of your subheadings to explain why they act to create risks or how they could affect shareholders in an adverse way. You may find it helpful to use an "if...then" approach to writing the subheadings, where "if" denotes the risk and the "then" discloses the specific adverse consequences of that risk. 13. Many of your risk factors are generic in that they could apply to almost any company that is trying to develop drugs. Please amend the risk factors to include specific disclosure and language explaining exactly what risks you face and how the issues raised in your current risk factor disclosure apply to you. We expect that you will substantially amend many of the risk factors in response to this comment, and may have further comments upon reviewing your revised risk factors. 14. Please consider including a stand-alone risk factor disclosing the risks associated with the use of third parties in administering or conducting your clinical trials, if applicable. 15. Please consider including in a risk factor to disclose any adverse side effects or reactions to the applications of AIT(tm), Chimigen(tm) and T-ACT(tm). 16. Please consider including a risk factor that identifies your principal suppliers and the types of materials provided by them. Also, please include a discussion of the risks inherent in supply agreements. For example, the risks in obtaining another suitable source of supply, use of sole-source suppliers, reliance on suppliers` ability to manufacturer sufficient quantities, etc. 17. Please also indicate whether these parties currently meet your manufacturing requirements for your pre-clinical and clinical trials. 18. Please consider including a risk factor which addresses foreign currency and exchange rate risks as it relates to Canadian, US, and other foreign denominated currency. All of the corporation`s potential products..., page 14 19. Please expand the first paragraph of this risk factor to state that you have never successfully developed any products or obtained regulatory approval to sell any product and have never derived revenue from the sale of products. Pharmaceutical products are subject to intense regulatory approval processes, page 16 20. Please include a separate stand alone risk factor that addresses the risks associated with conducting clinical trials. You should discuss the possibility and ramifications of the following. * delays in identifying and reaching agreement on acceptable terms with institutional review boards of clinical trial providers and prospective clinical trial sites * delays in obtaining FDA or other regulatory agency clearance to commence a clinical trial * delays in the enrollment of patients * lack of effectiveness of a product candidate during clinical trials * adverse events or safety issues * cost overruns 21. Please expand on your discussion of Health Canada. For example, does Health Canada regulate drug development companies in a similar manner to the FDA? Furthermore, does it require pre-market approval for product candidates, observing them for efficacy and safety in several phases? Also, discuss the risk that even if you obtain regulatory approval from one of the regulatory bodies you mention, that you may have to expend substantial time and resources to obtain similar regulatory approval to sell your potential products in other markets and that this could limit your market opportunity and adversely affect your operating results. 22. Also, please revise to indicate if you have any products candidates for approval before any agency, including any foreign agencies. If so, please revise to identify the agency, the product and the specific approval you are seeking. The biotechnology industry is extremely competitive and the Corporation ..., page 17 23. Please identify by name and specify product offerings (or product candidates) of the primary competitors of ViRexx of which you are aware. Also, to the extent obtainable, please disclose your principal competitors` share of the target market. The Corporation relies on patents and proprietary rights to protect its technology, page 17 24. Please disclose whether you have the obligation to protect and bear the cost of defending the patent rights you license from other companies and institutions such as the master cell bank licensed from Biomira Inc. for OvaRex(r) MAb, the University of Alberta and the Alberta Cancer Board. 25. Additionally, in your section entitled, "Patents" on page 46 you should provide a detailed discussion that provides the material rights of you and the other party and the obligations and conditions necessary for you to maintain your license and corresponding use of the patent(s). Also, please disclose the expiration date of all patents you currently own or have licensed from third parties. 26. If you are aware of any potential issues related to your infringement or violation of another party`s patent, please describe the situation or if your business has been materially and adversely affected by the disclosure of proprietary information, please discuss the situation and its consequences. The Corporation`s products may fail or cause harm, subjecting the Corporation ..., page 18 27. Please disclose if you anticipate obtaining product liability insurance coverage in the near term. New products may not be accepted by the medical community or consumers, page 18 28. Please revise this risk factor to expand on the risks and potential adverse consequences of utilizing third parties to market your products. Your discussion should include, but not be limited to, conflicts of interest and margin differences in connection with other products the marketer may be marketing, material decreases in sales due to contract breaches or terminations, disputes, the financial and functional wherewithal of your marketers, etc. The Corporation is dependent on the success of its strategic relationships ..., page 19 29. It appears that you discuss multiple risks in the text of this risk factor. Please unbundle your disclosure into separate risk factors that discuss the following distinct risks: dependence on third party collaboration agreements; failure to enter into strategic relations for product development on terms favorable to you; and the risks associated with using third party manufacturers and suppliers. You may need to expand your discussion(s) in each of these risk areas. The Corporation has no operating revenues and a history of losses, page 20 30. Please revise to state your accumulated deficit since inception. 31. Please revise the last sentence to read even after successful commercialization of one or more products you may never achieve profitability. 32. Please consider including a stand-alone risk factor discussing the fact that you have no products available for commercial sale, have never had any revenues from commercial sales, that you may never have commercial sales of an approved product and have relied on equity and debt financings to support your operations. The Corporation may need additional financing in the future to fund the research ..., page 20 33. You state that your average monthly cash usage for 2005 will be approximately $650,000. In MD&A, please discuss commitments to expend cash which comprise these amounts and discuss the relevant demands, commitments and uncertainties concerning your calculations of this burn rate. 34. Please revise the words "may need" in the subheading to indicate that it is likely that the Company will require additional funding to reach profitability. As you are operating at a considerable loss and your expenses are outpacing your limited resources, it appears more likely than not that you will require additional funding. 35. We note you anticipate needing additional funds. Please disclose how much additional funding you anticipate needing and when you intend to raise it. The Corporation is dependent on its key employees and collaborators, page 21 36. Please revise your discussion to disclose the identities of your significant scientific and management personnel and the material provisions of your employment agreements with each of them, if applicable, including duration of employment. 37. If you have had problems attracting or retaining qualified employees, please revise to describe the problems you have experienced. Additionally, if any key employee has plans to retire or leave your company in the near future, please revise the discussion to disclose this information. 38. Please revise to disclose whether you currently have key man life insurance on key officers and significant employees and if so, please disclose their identity. As a non-US Corporation, it may be difficult for shareholders to pursue claims ..., page 21 39. Please consider including a separate risk factor to disclose whether there is any potential difficulty for an investor to bring actions in U.S. courts against the company because of its status as a foreign company. In this regard, any additional disclosure should include the following: * the extent to which an investor could effect service of process in the United States against ViRexx Medical Corp. and/or any of its non- U.S. resident officers, directors, and experts named in the registration statement; * the extent to which Canadian courts provide comity for judgments of U.S. courts; * the extent to which a U.S. investor can bring original actions in Canadian courts against the company based on U.S. law; and * the extent to which an investor could enforce in a Canadian court any U.S. court judgments based on the civil liability provisions of the U.S. federal securities laws against ViRexx or any of the above foreign persons. If there is uncertainty regarding a particular matter, clearly identify those matte