Mail Stop 6010
August 3, 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 July 14, 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
Risk Factors
"If we lose our key personnel or are unable to attract and retain
additional . . . .," page 9
1. We note the disclosure in the subsection of your document
entitled
"Employment Agreements" pertaining to agreements you have with
your
chief financial officer and chief scientific officer,
respectively.
Please tell us why you have not specifically identified these two
individuals in this risk factor. The fact that you have employment
agreements with both of these individuals appear to suggest they
are
"key personnel" that should be included in this risk factor. In
the
alternative, please revise this risk factor to add those
individuals
to this risk factor.
"Our current restructuring plan may not achieve the results we
intend
and . . . .," page 11
2. We note your response to comment 21 and reissue the comment in
part. The inclusion of a cross-reference to Item 8. of your Form
20-
F does not satisfy our comment as such item does not appear to
indicate whether you intend to make additional workforce
reductions
in the next 12 months. Please revise your risk factor
accordingly.
"Our results of operations may be negatively affected by the
obligation . . . ., page 16
3. Delete the phrase "under certain circumstances" since it is
vague
and potentially misleading.
HepeX-B (Product for the Prevention of Re-Infection of Hepatitis
B),
page 20
4. We note your response to comment 32 and your revised
disclosure.
Please describe any statistical analysis conducted on the study.
If
no such analysis was done, please so state.
XTL-6865, page 21
5. We note your response to comment 35 and reissue the comment in
part. Please disclose what statistical analysis, if any, 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. If no such statistical analysis
was
performed on the studies, please so indicate.
6. We note your response to comment 36 and reissue the comment in
part with respect to information concerning payments received/made
to
date; and additional aggregate potential payments. Please note
that
the information requested by our prior comment 36 is generally not
appropriate subject matter for confidential treatment requests as
we
believe this information is material to investors. Additionally,
please note that after our review of your confidential treatment
application, we may issue additional comments relating to
discussion
of several of your agreements you discuss in Item 4.
XTL-2125 License, page 26
7. We note your response to comment 37 and your supplemental
response
that you do not believe your agreement with B&C Biopharm Co., Ltd.
is
a material agreement. Your disclosure in the document, however,
appears to suggest otherwise. For example, you refer to the XTL-
2125
as your "lead product candidate" from your HCV-SM small molecule.
Please provide us with further analysis as to why you believe this
agreement is not material to you, including the costs you have
paid
to date to acquire the XTL-2125 license and the cost to date you
have
incurred for the research and development of this product; when
you
acquired the license; what progress you have made to the product
as
well as the current phase of development; and whether you are
obligated to pay any part of the milestone payment prior to
commencing sale of the product.
Item 5. Operating and Financial Review and Prospects, page 32
Liquidity and Capital Resources, page 41
8. We note that both you and your auditors believe that the
continuation of your current operations, after utilizing your cash
reserves in 2006, is dependent upon the generation of additional
financial resources, either through agreements for the
commercialization of your product portfolio or through external
financing. Please revise your disclosures to: (a) focus on this
dependency, (b) elaborate on the likelihood that you will be able
to
generate additional financial resources in either of the ways that
you mentioned, and (c) the reasonably
Research and Development, Patents and Licenses, page 43
9. We note the disclosures you provided in response to our prior
comment number 38. For each period presented, please disclose the
total research and development costs, as defined by SFAS 2, and
reconcile that amount to the sum of the project costs you have
disclosed. If you exclude any of the following, please tell us
why
they do not represent research and development costs, as defined
by
SFAS 2: (a) your costs of revenues or (b) the costs you have
reduced
by the amounts you received under participations.
Non-plan Share Options, page 56
10. Please indicate what licensing agreement you are referring to,
and the specific reasons the consultants received the shares
pursuant
to the licensing agreement.
Memorandum and Articles of Association, page 58
11. We note your response to comment 45 and reissue the comment in
part. Please disclose whether your articles or Israeli law permits
shareholders to approve corporate matters by written consent.
Item 19. Exhibits, page 84
12. We note your response to comment 47 and note that many of your
exhibits still remain to be filed. As previously noted, we may not
clear comments on your registration statement until we have
reviewed
these comments. To that end, please file your remaining exhibits
with your next amendment or as soon as they become available as
will
require some time to review the exhibits.
* * *
File a pre-effective amendment in response to these
comments.
Provide a letter keying your responses to the comments, and
provide
any requested supplemental information. If you believe complying
with these comments is not appropriate, tell us why in your
letter.
The response letter should be uploaded to EDGAR, with the form
type
label "CORRESP" and linked to the registration statement file
number.
We may have comments after reviewing revised materials and your
responses.
You may contact Tabatha Akins at (202) 551-3658 or Oscar
Young
at (202) 551-3622 if you have questions regarding comments on the
financial statements and related matters. Please contact Song
Brandon at (202) 551-3621, John Krug at (202) 551-3862 or me at
(202)
551-3710 with any other questions.
Sincerely,
Jeffrey Riedler
Assistant Director
cc: Mark F. McElreath, Esq.
Alston & Bird LLP
90 Park Avenue
New York, NY 10016
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