SEC Comment Letter for Hana Biosciences Inc (CIK 0001140028) — Jan 18, 2005
Hana Biosciences Inc (CIK 0001140028)
Date: Jan. 18, 2005 · CIK: 0001140028 · Accession: 0000000000-05-002942
AI Filing Summary & Sentiment
File numbers found in text: 333-118426
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Mail Stop 0309 September 20, 2004
Mark J. Ahn, Ph.D.
President and CEO
Email Real Estate.com, Inc.
400 Oyster Point Boulevard, Suite 215
South San Francisco, CA 94080
Re: Email Real Estate.com, Inc.
Registration Statement on Form SB-2, filed August 20, 2004
File No. 333-118426
Dear Dr. Ahn:
We have reviewed your filings 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.
General
1. 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 applicable to portions of the filing that we have
not cited as examples, please make the appropriate changes in
accordance with our comments.
2. Please provide notice of your intended change in fiscal year by
filing Form 8-K (Item 5.03) and provide any transitional reports
that
are required.
Summary, pages 3-4
3. We note that currently you appear to highlight certain positive
aspects of your company and its strategy. The summary section
should
provide a brief, but balanced description of the key aspects of
the
company as of the latest practicable date. Please revise your
summary
to balance the discussion with an equally prominent discussion of
the
risks and obstacles in implementing your strategy. This also
means
that you cannot satisfy the comment by merely providing a cross-
reference to the risk factors section. For example, you should
briefly discuss that you have no product revenues, have a history
of
losses and will need to raise additional capital to operate your
business.
4. We refer to your statement that "Preclinical studies with IPdR
in
several animal models has demonstrated that IPdR and radiation
therapy is superior in terms of safety and efficacy when compared
to
radiation therapy and IUdR." We believe discussions regarding the
results of preclinical and clinical trials are better placed in
the
Business section where investors have more complete disclosure
about
the trials and the FDA process. Please revise your disclosure
accordingly.
Recent Developments, page 3
5. We note that you are registering for resale outstanding common
stock and common stock to be issued on the conversion of Series A
Convertible Preferred Stock and Series B Convertible Preferred
Stock.
Did the merger between Email Real Estate.com and Hana Biosciences
constitute a triggering event, which will result in the automatic
conversion of both the Series A and Series B Preferred Stock? If
it
is not a triggering event, provide us with an analysis supporting
your determination that it is not premature to register the resale
of
the underlying shares of each series of preferred stock at this
time.
Risk Factors, pages 5-15
6. Please consider grouping your related risk factors together
under
three classified headings instead of two by separating risks
related
to your industry under a separate heading.
7. Please revise each subheading to ensure it reflects the risk
that
you discuss in the text. Many of your subheadings currently
either
merely state a fact about your business, such as "Trading of our
common stock is limited" or describe an event that may occur in
the
future, such as "We do not expect to pay dividends." Succinctly
state in your subheadings the risks that result from the facts or
uncertainties.
"Trading of our common stock is limited." Page 5
8. Please revise to disclose your current trading volume.
"Because it is a `penny stock,` it will be more difficult for you
to
sell shares of our common stock." Page 5
9. Please expand to discuss the monthly statements that brokers
must
provide to investors of penny stocks.
10. Please expand to discuss the specific legal remedies available
to
investors of penny stocks.
11. In an appropriate section of your document, please describe
Rules
3a51-1, 15g-1, 15g-2, 15g-3, 15g-4, 15g-5, 15g-6, 15g-7 and 15g-9
of
the Exchange Act and their effects on your stockholders.
"A significant number of shares of our common stock are or will
become available for sale and their sale could depress the price
of
our common stock." Page 5
12. Please revise to disclose the number of shares of your common
stock that currently are available for sale and that will become
available for sale upon the effectiveness of this registration
statement.
13. Please also revise to disclose the number of any additional
shares you currently expect to issue and generally when those
shares
will be available for sale. For example, please describe any
shares
you expect to issue pursuant to option grants and when the terms
of
those grants will permit those shares to be salable.
"Our stock price is, and we expect it to remain, volatile, which
could limit investors` ability to sell stock at a profit." Pages
5-6
14. To illustrate the fluctuations of your stock price, please
provide a range for your common stock price since the announcement
of
your reverse acquisition by Hana Biosciences. Please note, it is
not
necessary to repeat the market price table provided later in the
prospectus. Disclosure of the high and low price during this time
period is sufficient.
"Because we became public by means of a reverse merger, we may not
be
able to attract the attention of major brokerage firms." Page 7
15. Please revise to describe the "additional risks" to which you
refer.
"We currently have no product revenues and will need to raise
additional capital to operate our business." Page 7
16. Please revise your disclosure in this risk factor to briefly
describe your "operations" for which you have sufficient cash to
fund. This additional disclosure will help investors better
understand the impact of a change in your capital resources or
expenditures.
17. Please revise to disclose your expected expenditures over the
next 18 months as you have disclosed on page 20.
"We are not currently profitable and may never become profitable."
Pages 7-8
18. Please disclose your net losses for the last two fiscal years.
19. Please incorporate into this discussion the rate at which you
are
currently burning cash on a monthly basis. In that regard we note
a
statement recently made by your CEO published in an article dated
July 26, 2004 in BIOWORLD Today, "Hana is burning about $200,000 a
month, Ahn said."
"We have a limited operating history upon which to base an
investment
decision." Page 8
20. Please revise to disclose that you just recently acquired the
rights to one of your two product candidates, IPdR, in February
2004.
"We may not obtain the necessary U.S. or worldwide regulatory
approvals to commercialize our product candidates." Pages 8-9
21. To the extent known or easily obtainable, please disclose the
historical rate of success for drug candidates. We note that
various
industry sources cite statistics of the percentage of NDAs that
are
accepted for filing or product candidates that enter clinical
trials
that are ultimately granted FDA approval.
"Our product candidates are in early stages of clinical trials."
Page
9
22. We note your statement that "The IND for IPdR is still under
development and we do not expect to commence a Phase I trial until
at
least late 2004." In your summary, however, you state that for
IPdR
you "filed an IND with the FDA in August 2004 and hope to begin
Phase
I trial by early 2005." Is your IND for IPdR still under
development
or have you completed the IND? In addition, your statements
regarding the timing of a Phase I trial may be confusing, as one
statement implies late 2004 and the other states 2005. Please
revise
here, in the summary and elsewhere in the prospectus to clarify.
23. Additionally, this risk factor states a fact without
describing
the risk or potential consequences. Please revise to discuss that
obtaining FDA approval is a lengthy and expensive process and that
you will not be in a position to generate product revenue for
years,
if at all. Additionally, discuss the fact that often, clinical
trials are discontinued in later stages of development.
"Physicians and patients may not accept and use our drugs." Page
10
24. We note that you have not listed price as a factor that might
impact acceptance of your product. Even though you discuss price
in
more detail in the risk factor on page 14, please disclose this as
a
potential factor.
"Our drug-development program depends on third-party researchers
who
are outside our control." Page 10
25. We note your statement that you depend on collaborators. Are
the
collaborators the same as the licensors described in the
"Business"
and "Management`s Discussion and Analysis?" If you are referring
to
something other than the agreements that have already been
described,
then revise the risk factor discussion to clarify, revise
"Business"
to provide a description of the material terms of these agreements
and file them as exhibits. Alternatively, if you currently do not
have any collaboration agreements and are dependent on entering
into
collaboration agreements, please revise to disclose that you are
dependent on entering into such agreements but as yet have not
successfully entered into any.
26. To the extent that you are substantially dependent on any
third
party researchers, please describe the material terms of your
agreements with them in your Business section and file your
contracts
with them as exhibits to the registration statement. If you are
not
substantially dependent on any of these parties, disclose the
approximate number of parties performing these services and name
any
key parties.
"If we cannot compete successfully for market share against other
drug companies, we may not achieve sufficient product revenues and
our business will suffer." Page 12
27. Please revise to identify the key competitors you expect to
compete with for market share and whether they have products or
product candidates that are further advanced that yours.
"If we fail to adequately protect or enforce our intellectual
property rights or secure rights to patents of others, the value
of
our intellectual property rights would diminish." Pages 12-13
"If we infringe the rights of third parties we could be prevented
from selling products, forced to pay damages, and defend against
litigation." Page 13
28. Please update to disclose whether there have been threats of
litigation or negotiations regarding patent issues or other
intellectual property, court challenges, legal actions, etc.
"Our ability to generate product revenues will be diminished if
our
drugs sell for inadequate prices or patients are unable to obtain
adequate levels of reimbursement." Page 14
29. Please discuss the impact, if any, of the recent Medicare
legislation.
"We may not successfully manage our growth." Page 14
30. Please revise to provide more detail on your anticipated
expansion. For example, please state how you expect to expand
your
facilities, do you expect to lease additional space, purchase new
facilities or build new facilities. How many and what type of
additional personnel do you expect to hire? In addition, to the
extent practicable, please quantify any expected expenditures. In
that regard, we note your disclosure on page 20 regarding your
expected expenditures over the next 18 months. Please also revise
your disclosure on page 21 accordingly.
31. Additionally, describe the potential effects if you are unable
to
manage your growth rather than just stating your business would be
harmed.
"We may be exposed to liability claims associated with the use of
hazardous materials and chemicals." Page 14
32. Please disclose whether you maintain insurance for the use of
hazardous materials and chemicals and, if so, the level of
coverage.
Please also disclose the cost to you of such coverage, if
material.
33. Please discuss if you have been the subject of any
investigations
in the past.
"We rely on key executive officers and scientific and medical
advisors, and their knowledge of our business and technical
expertise
would be difficult to replace." Page 14
34. Please name your key personnel and their positions with the
company.
35. To the extent that you have experienced problems attracting
and
retaining key personnel in the recent past, please revise to
describe
these problems. 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.
36. Please state whether you maintain employment contracts with
key
personnel and disclose the term and termination provisions of the
same if applicable.
"If we are unable to hire additional qualified personnel, our
ability
to grow our business may be harmed." Page 15
37. Please revise to disclose the number and type (i.e.
scientific,
administrative, sales and marketing) of personnel you expect to
hire
and to the extent practicable, please quantify any expected
expenditures in hiring such personnel.
"We may incur substantial liabilities and may be required to limit
commercialization of our products in response to product liability
lawsuits." Page 15
38. We note your statements that you do not have clinical trial
insurance or product liability insurance but you intend to obtain
it
prior to commencement of clinical trials. As you have commenced
clinical trials for PT-523, please revise to update this
disclosure.
If you are conducting clinical trials without insurance, please
specifically disclose this information. If you have obtained
clinical trial insurance, please revise to disclose the policy
limitations. If you expect this expense to have a material effect
on
your results of operations, then please quantify the costs.
Management`s Discussion and Analysis of Financial Condition and
Results of Operations, pages 16-23
39. We note that your plan of operation for the next twelve months
appears to be limited in scope and does not address all of the key
variables and other qualitative and qualitative factors necessary
for
a proper understanding and evaluation of the Company. Please
expand
your discussion to cover the planned expenditures and expected
drug
development as presented in the development plans on pages 31 and
37
of the filing. Include a discussion of employees to be hired and
other expansion of the Company`s infrastructure.
40. Please revise your MD&A so that there is more focus on
analysis
as required by our recent MD&A Release No. 33-8350; 34-48960; FR-
72
(December 19, 2003). In that release, we explained that "MD&A
requires . . . an `analysis` of known material trends, events,
demands, commitments and uncertainties. MD&A should not be merely
a
restatement of financial statement information in a narrative
form. .
. . A thorough analysis often will involve discussing both the
intermediate effects of those matters and the reasons underlying
those intermediate effects." For example:
* Why have your payroll expenses increase? If you have increased
the
number of employees, revise to disclose the number of new
employees;
* We note rent and utilities expenses have increases significantly
for the six months ended June 30, 2004, do you have a new
facili