SEC Comment Letter for XTL BIOPHARMACEUTICALS LTD (XTLB) (CIK 0001023549) (XTLB) — Jun 8, 2005
XTL BIOPHARMACEUTICALS LTD (XTLB) (CIK 0001023549)
Date: June 8, 2005 · CIK: 0001023549 · Accession: 0000000000-05-028585
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<DOCUMENT> <TYPE>LETTER <SEQUENCE>1 <FILENAME>filename1.txt <TEXT> Mail Stop 6010 June 8, 2005 Jonathan Burgin Chief Financial Officer XTL Biopharmaceuticals Ltd. Kiryat Weizman Science Park 3 Hasapir Street, Building 3, P.O. Box 370 Rehovot 76100, Israel Re: XTL Biopharmaceuticals Ltd. Form 20-FR12G filed on May 12, 2005 File No. 0-51310 Dear Mr. Burgin: We have reviewed your filing and have the following comments. Where indicated, we think you should revise your documents 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 20-FR12G General 1. We note from your exhibit index that you intend to seek confidential treatment for certain exhibits. In that regard, please be advised that comments related to your request for confidential treatment will be delivered under separate cover. We will not be in a position to consider clearance of this registration statement until we resolve all issues concerning the confidential treatment request. Forward-Looking Information, page 1 2. It appears that much of this discussion is already included in the Risk Factor section of your document. In that regard, please revise to limit the discussion to a warning concerning forward-looking information. 3. We note your statement that you are claiming the "protection of the safe harbor for forward-looking statements contained in the Private Securities Litigation Reform Act of 1995." 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. Therefore, please delete your statement. Risks Related to Our Business, page 4 4. We note the language contained in your auditor`s report that "continuation of the Company`s current operations after utilizing its current cash reserves during 2006 is dependent upon the generation of additional financial resources, either through agreements for the commercialization of its product portfolio or through external financing." It is unclear if the auditors have expressed a going concern opinion about your business. If the auditors have expressed a going concern opinion, please consider adding a separate risk factor discussing the risks and consequences stemming from the going concern opinion. In addition, please add disclosure in the risk factor entitled "If we are unable to obtain additional funds on terms favorable . . . ." on page 9 to describe the effects your going concern may have on your ability to raise additional funds. "We have a limited operating history and have incurred substantial operating losses . . . .," page 4 5. Please relocate the last full paragraph of this risk factor to a new risk factor discussing the fact that you have no products available for commercial sale, have never had any revenues from commercial sales and have relied on equity and debt financings to support your operations. "If third parties on which we rely for clinical trials do not perform as contractually . . . .," page 5 6. Please identify the independent clinical investigators and other third party service providers you refer to in this risk factor, if you materially rely on such individuals or entities. In addition, please describe the terms of any agreements you have with these third parties in the section entitled "Information About the Company," and file any agreements you have with them as exhibits. In the alternative, please provide us with a detailed analysis explaining why any agreements you have with such third parties are not material to you. "If the clinical data related to our drug candidates do not track positive preclinical . . . .," page 5 7. Please clarify what you mean by "relatively early stage of development." Please also identify the certain of your drug candidates in that stage. Please also identify the drugs that have not been tested in humans. "If our drug candidates do not receive the necessary regulatory approvals, we will . . . .," page 5 8. Please revise this risk factor heading to reflect that you have limited experience in conducting and managing clinical trials necessary to obtain regulatory approval. 9. Please also 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. "Because we license in some of our proprietary technologies from third-parties, . . . ," page 6 10. Please identify the drug candidates and technologies that you refer to in this risk factor. Please also disclose the expiration date of the patent rights. 11. Please indicate who has the obligation to protect and bear the cost of defending the licensed patent rights. In addition, in your section entitled, "Intellectual Property and Patents," 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). 12. If you are aware of any potential issues related to your infringement or violation of another party`s patent, please revise to describe the situation. 13. You also indicate that "under the terms of certain of our license agreements, we are required to obtain approval from such third parties in order to grant sublicenses to collaborative partners to develop or commercialize its products or products derived from its technologies." Please identify the certain license agreements you are referring to in this risk factor. "If the third parties upon whom we rely to manufacture our products do not . . . .," page 7 14. Please revise to identify all manufacturers you currently substantially rely on to produce materials for your preclinical and clinical testing purposes. Additionally, revise your "Information About the Company" section to disclose the material terms of these agreements, and file the agreements as exhibits. If you have determined that you are not substantially dependent on them, provide us with an analysis supporting this determination. 15. Please also indicate whether these parties currently meet your manufacturing requirements for your pre-clinical and clinical trials. "If our competitors develop and market products that are less expensive, more . . . .," page 8 16. We note your statement that "[o]ther companies have products or drug candidates in various stages of pre-clinical or clinical development to treat diseases for which we are also seeking to discover and develop drug candidates." Please identify these competitors. "If we lose our key personnel or are unable to attract and retain additional . . . .," page 8 17. Please identify the key officers and management employees that you refer to in this risk factor. In addition, please indicate if you maintain any employment agreements with such individuals. If so, please disclose the material provisions of the employment agreements in the Directors, Senior Management and Employees section of your prospectus and file the agreements as exhibits to your registration statement. 18. Please also revise to disclose whether or not you currently have any key man life insurance. 19. To the extent that you have experienced difficulties attracting and retaining key personnel, please revise to discuss these difficulties. Also, disclose whether any key personnel have plans to retire or leave your company in the near future. "If we are unable to obtain additional funds on terms as favorable to us, or at all . . . .," page 9 20. You state that you anticipate needing additional funds. Please disclose how much additional funding you anticipate needing and when you intend to raise it. Please also include in your discussion, the average amount of cash you are using on a monthly basis or expect to use on a monthly basis in connection with your research development efforts for the next 12-18 months. "Our current restructuring plan may not achieve the results we intend and may . . . .," page 10 21. We note that at March 31, 2005 you had 45 full time employees. Please indicate the number of full time employees you currently have as a result of your workforce reduction. Do you anticipate on making additional workforce reductions in the next 12 months? 22. Please also revise this risk factor to discuss that as part of the restructuring plan, you intend to defer all research and development activities not supporting the lead clinical programs until proof of concept has been achieved in at least one of the two lead programs. We note you have provided for this disclosure on page 53. "If we are unable to adequately protect our intellectual property . . ., page 10 23. Since you have licensing rights in China for at least one intellectual property (see page 59 regarding your co-licensing rights in China for "Ab65"), disclose that some of the countries, such as China, in which you intend to do business do not protect a company`s intellectual property to the same extent as the United States or Israel. "If we are unable to adequately protect our intellectual property, third parties may . . . .,"page 10 24. Please describe any current or pending patents. In your description, please disclose the expiration dates of your key patents and the importance of each of the patents to your business. Please provide similar disclosure in the section entitled "Intellectual Property and Patents" on page 18. 25. 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. "Holders of our ordinary shares who are United States residents may be . . . .," page 13 26. Disclose whether you believe that you currently are or have been a PFIC during the periods examined (fiscal years 2002, 2003 and 2004). "Our results of operations may be negatively affected by the obligation of . . . .," page 14 27. Disclose that under Israeli law male Israeli citizens are subject to compulsory military service until middle age. "Our results of operations may be adversely affected by inflation and foreign . . . .," page 15 28. Please quantify the percentage of your expenses incurred in New Israeli Shekels, if such amount is material. "We may not continue to be entitled to certain tax benefits from the Israeli government," page 15 29. Please explain what it means to be an "approved enterprise" under Israeli laws and regulations. Briefly also explain what it requires for you to receive "approved enterprise" status. Please also expand your discussion to discuss what certain reporting requirements you must meet in order to maintain the approved enterprise status. "It may be difficult to enforce a U.S. judgment against us, our officers or our . . . .," page 15 30. Please expand this risk factor to discuss in more detail the following: * the extent to which a U.S. investor can bring original actions in Israeli courts against the company based on U.S. federal securities laws law; and * the extent to which an investor could enforce in a Israeli court U.S. court judgments based on the civil liability provisions of the U.S. federal securities laws against the Company or any of the above foreign persons. In addition, if there is uncertainty regarding a particular matter, clearly identify those matters and state the reason(s) for the uncertainty. Item 4. Information on the Company, page 16 31. We note your disclosure of the results of your preclinical and clinical trials throughout this section. Please revise your discussions to include appropriate caveats indicating that the results do not provide enough evidence regarding efficacy or safety to support an application with the FDA, that additional tests will be conducted and that subsequent results often do not corroborate earlier results. HepeX-B (Product for the Prevention of Re-Infection of Hepatitis B) 32. We note your disclosure that in "previous clinical studies, HepeX-B maintained serum antibody levels similar to HB1g, using significantly less protein, thus enabling the development of low- volume `patient-friendly` formula." Please indicate who conducted the "previous clinical studies." Please also describe what the clinical studies entailed, including the number of patients who participated in the study, the duration of the study and any relevant statistical data. XTL-6865 and XTL-2125 (Products for Prevention of Re-Infection and Treatment for Hepatitis C), page 18 33. Please provide us with third party documentation supporting the statistical and related information you make in the subsection entitled "Preventing Re-infection following Liver Transplant" and "Treating Chronic HCB." These reports should be marked to indicate the supporting information. In addition, please cite the third party support in your document. If you are unable to provide us with the above requested third party support, please delete these statements. 34. Please provide us with the basis for your statement that you estimate "that a successful therapy for preventing re-infection with HCV following liver transplantation could reach annual worldwide sales of approximately $400 million." XTL-6865, page 19 35. Whenever you discuss the results of Phase II or III trials, you should define the groups you tested, 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. Please also explain what the P value measures in your document. XTL-6865 License, page 23 36. Please expand your description of the agreements you have with DRK-Blutspendedienst Baden-Wurttemberg, Stanford University and Applied Immunogenetics LLC, to include the following information, to the extent applicable: * All material rights and obligations of the parties to the agreement; * Payments received/made to date; * Additional aggregate potential payments; * Any revenue sharing arrangements; and * Expiration date and termination provisions. Please note that aggregate licensing and aggregate milestone payments should be disclosed and quantified. XTL-2125 License, page 24 37. We note your brief discussion concerning your agreement with B&C Biopharm Co., Ltd. It does not appear you have filed this agreement as an exhibit, please do so in your next amendment. In addition, please expand your discussion to provide the conditions or requirements that you must maintain in order to maintain the license, the expiration date and termination provisions and the aggregate licensing and aggregate milestone payments you may pay under the agreement. If you do not believe such agreement is material to you, please provide us with a detailed analysis explaining the reasons. Research and Development, Patents and Licenses, page 41 38. We note that you have three products that are currently under development. Plea