SEC Comment Letter for INOVIO PHARMACEUTICALS, INC. (INO) (CIK 0001055726) (INO) — Apr 26, 2005
INOVIO PHARMACEUTICALS, INC. (INO) (CIK 0001055726)
Date: April 26, 2005 · CIK: 0001055726 · Accession: 0000000000-05-020352
AI Filing Summary & Sentiment
File numbers found in text: 333-123619
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April 25, 2005
Mail Stop 0306
Avtar Dhillon
Chief Executive Officer and President
Genetronics Biomedical Corporation
11494 Sorrento Valley Road
San Diego, CA 92121-1318
Re: Genetronics Biomedical Corporation
Registration Statement on Form S-3 filed March 28, 2005
File No. 333-123619
Form 10-K for the Fiscal Year Ended December 31, 2004
File No. 1-14888
Dear Mr. Ryan:
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-3
Registration Statement Cover Page
Prospectus Cover Page
1. We note that on March 31, 2005, you changed your corporate name
to
"Inovio Biomedical Corporation" and effective April 4, 2005, your
ticker symbol changed to "INO." Please revise the cover pages to
reflect these changes, and briefly discuss the name/ticker change
in
the Summary section. Also provide your new website address.
Prospectus Summary - Page 1
2. Please ensure that the disclosure in your summary is balanced.
For example, please revise your summary to highlight the fact that
you have a history of operating losses and, if true, that you have
yet to commercialize any viable products.
3. Please provide supplemental support for your statements of
industry leadership. For example, we note your disclosure on page
3
that you are "[positioned] as a leader in EPT," and that you are a
"leader in the [DNA delivery] field" on page 4.
4. Please revise so that the meaning of all technical and
industry-
specific terms is clear from the context of your discussion. For
example, we note the reference to "cryoablation and "radio
ablation"
on page 3 and "intralesionally-injected" bleomycin on page 4.
5. Please briefly describe the significance of the "orphan
designation" granted by the FDA. We reference your disclosure on
page 4.
6. Please describe the term "thought leaders" mentioned on page 5.
It is also unclear exactly what expenses you may apply for
reimbursement. Are you referring to expenses associated with the
commercialization of this product or are you referring to
reimbursements from Medicare and similar international agencies
for
treatments utilizing your products? Please clarify.
Risk Factors - Page 3
General
7. Please eliminate the second and third sentences of the
introductory paragraph and revise as necessary to include a
discussion of all material risks in the Risk Factors section.
Also
revise the "Additional or Updated Risk Factors" section on page 22
in
accordance with this comment.
8. Please describe under a separate appropriate heading the risks
to
potential investors associated with the fact that you have a
history
of losses and expect that to continue "for some time in the
future."
Also disclose your accumulated deficit as of the most recent
practical date.
9. We note that approximately 76% of your revenues for the 2004
fiscal year were generated from your collaboration and license
agreement with Merck. Under an appropriate heading, please
describe
the risks associated with the fact that a substantial portion of
your
revenues is generated by this relationship.
If we do not have enough capital to fund operations.... - Page 9
10. To the extent that you have engaged in discussions with other
companies regarding a potential merger or your acquisition, please
provide appropriate disclosure.
If we cannot maintain our existing corporate and academic
arrangements.... - Page 13
11. Please disclose which material sponsored research, license and
collaborative agreements can be terminated by your collaborative
partner with limited notice to you, as well as the percentage of
your
revenues represented by any such relationship.
We rely heavily on our patents and proprietary rights.... - Page
15
12. Please disclose whether you are currently aware of any parties
currently intending to pursue such infringement claims against
you.
Serious and unexpected side effects attributable to gene therapy
may
result.... - Page 16
13. Please provide additional disclosure regarding the "serious
adverse events" you reported to the FDA and other regulatory
agencies
and what, if any, action was taken by such agencies upon your
notification. We may have further comment.
Any acquisition we might make may be costly and difficult to
integrate.... - Page 17
14. If you have experienced any such difficulties relating to your
acquisition of Inovio in January 2005, please provide appropriate
disclosure.
We may not meet environmental guidelines.... - Page 21
15. To the best of your knowledge, please tell us whether you are
in
current compliance with all applicable environmental regulations.
Selling Stockholders - Page 23
16. Please provide the exemptions from registration under the
Securities Act of 1933 for all transactions described on page 23.
17. Please identify the individuals who have or share voting
and/or
investment control over the shares owned by the entities listed in
the table.
18. Please tell us whether any of the selling shareholders are
broker-dealers or affiliates of a broker-dealer. Any selling
shareholder who is a broker-dealer must be identified in the
prospectus as an underwriter. In addition, each selling
shareholder
who is an affiliate of a broker-dealer must be identified in the
prospectus as an underwriter unless that selling shareholder is
able
to make the following representations in the prospectus:
* The selling shareholder purchased the shares being registered
for
resale in the ordinary course of business, and
* At the time of the purchase, the selling shareholder had no
agreements or understandings, directly or indirectly, with any
person
to distribute the securities.
Please revise accordingly.
Incorporation of Certain Documents by Reference - Page 31
19. We note that you filed a Form 8-K on April 12, 2005, in
connection with your acquisition of Inovio. Based upon the
relative
significance of the acquiree, it appears to us that the related
Form
8-K should also be incorporated by reference to comply with Rule
3-05
and Article 11 of Regulation S-X. Incorporation by reference
would
also require that an additional accountants` consent be provided.
Please revise or advise, as appropriate.
20. In this regard, we note that the registration statement must
be
declared effective no later than 180 days following the closing
date
(January 25, 2005) or the company would be required to pay
penalties.
Supplementally discuss and quantify the amount of potential
damages
you would have to pay investors. Revise to disclose, or, if you
believe no disclosure is necessary, supplementally explain and
support.
Other
21. The financial statements and other relevant sections of the
filing should be updated, as necessary, to comply with Rule 3-12
of
Regulation S-X at the effective date.
22. Please include a currently dated and signed consent from your
independent auditors prior to requesting effectiveness.
Form 10-K for the Fiscal Year Ended December 31, 2004
General
23. Please revise your future filings, including your future
periodic
reports, as appropriate, in accordance with the preceding
comments.
Item 1. Business - Page 3
Partnerships and Collaborations - Page 7
24. We note your disclosure that you have entered into supply
agreements with Abbott Laboratories and Faulding to purchase
bleomycin for use with your MedPulser Electroporation Therapy
System.
We also note, however, your disclosure on page 13 of the
Registration
Statement on Form S-3 that you do not have a relationship with a
supplier of bleomycin at this time. Please clarify and tell us
supplementally whether these supply agreements have been
terminated.
Competition - Page 12
25. In future filings, please estimate the number of competitors
in
the industries in which you compete, name the dominant
competitors,
describe the principal methods of competition within your
industries
and, if known or reasonably available, provide your competitive
position. Refer to Item 101 (c) (x) of Item S-K.
Intellectual Property - Page 21
26. Please describe supplementally and in future filings the
importance to your business and the duration and effect of all
material patents. Refer to Item 101 (c) (iv) of Regulation S-K.
Item 7. Management`s Discussion and Analysis of Financial
Condition
and Results of Operations - Page 41
Results of Operations - Page 44
27. In future filings, when a description of known material
trends,
events, demands and commitments is set forth, expand your
discussion
to include both the intermediate effects of those matters and the
reasons underlying those intermediate effects. We note, for
example,
your disclosure that research and development activity decreased
in
2003, while salary, travel expenses and increased corporate
insurance
costs increased. Future filings should include a discussion of
the
factors that caused such increases/decreases, and whether you
expect
these trends to continue in the foreseeable future. Please refer
to
SEC Release No. 33-8350 for additional guidance.
Item 9A. Controls and Procedures - Page 52
28. We note on page 36 that you identified two significant control
deficiencies that "did not rise to the level of material
weakness."
Please explain the nature of these control deficiencies and how
you
determined they would have no material effect on the accuracy of
your
financial statements.
Notes to Consolidated Financial Statements
Note 8. Stockholders` Equity - Page F-15
Preferred Stock - Page F-16
29. In each transaction involving the issuance of warrants, please
tell us and expand your disclosures in future filings to explain
how
each issuance was valued. Address both the method and the
significant assumptions applied.
30. Supplementally and in detail, please tell us how you valued
and
recorded the beneficial conversion features of the Series A and B
Preferred Stock, including the assumptions utilized by your
valuation
model. In this regard, this information should be disclosed in all
future filings for material beneficial conversion features.
Additionally, you should provide an analysis of your significant
assumptions as part of your Management`s Discussion and Analysis.
Form 8-K/A filed April 12, 2005
Pro Forma Condensed Consolidated Statements of Operations - For
the
year ended December 31, 2004
31. It appears that the number of series D preferred stock to be
issued may be increased if the company achieves certain strategic
commercial milestones. Please revise to clearly explain the
potential
impact of that provision on the pro forma financial statements.
It
may be necessary to provide presentations using more than one set
of
assumptions. Discuss the consideration given to paragraphs 25-36
of
SFAS 141 in your response.
32. Refer to Note B. To the extent practicable, please expand
your
disclosures regarding IPR&D to address the method and significant
assumptions used to value it, as well as the nature and value of
individually significant projects.
33. Refer to Note E and your estimated useful life of 18 years for
the identifiable intangible assets. Why is an estimated useful
life
of 18 years appropriate? How did you apply the guidance in SFAS
142
paragraph 11 in estimating the useful life? Specifically address
the
nature and terms of the contracts being amortized over 18 years.
Report of Independent Auditors
34. We note that the financial statements were prepared in
accordance
with accounting principles generally accepted in Norway. In Note
12,
you indicate that there were no significant differences in net
income
(loss) or shareholders` equity between Norwegian GAAP and US GAAP.
Confirm there were not significant differences for the balance
sheet
as well.
* * *
As appropriate, please amend your registration statement in
response to these comments. You may wish to provide us with
marked
copies of the amendment to expedite our review. Please furnish a
cover letter with your amendment that keys your responses to our
comments and provides any requested supplemental information.
Detailed cover letters greatly facilitate our review. Please
understand that we may have additional comments after reviewing
your
amendment and responses to our comments.
We urge all persons who are responsible for the accuracy and
adequacy of the disclosure in the filings reviewed by the staff to
be
certain that they have provided all information investors require
for
an informed decision. Since the company and its management are in
possession of all facts relating to a company`s disclosure, they
are
responsible for the accuracy and adequacy of the disclosures they
have made.
Notwithstanding our comments, in the event the company
requests
acceleration of the effective date of the pending registration
statement, it should furnish a letter, at the time of such
request,
acknowledging that:
* should the Commission or the staff, acting pursuant to delegated
authority, declare the filing effective, it does not foreclose the
Commission from taking any action with respect to the filing;
* the action of the Commission or the staff, acting pursuant to
delegated authority, in declaring the filing effective, does not
relieve the company from its full responsibility for the adequacy
and
accuracy of the disclosure in the filing; and
* the company may not assert staff comments and the declaration of
effectiveness as a defense in any proceeding initiated by the
Commission or any person under the federal securities laws of the
United States.
In addition, please be advised that the Division of
Enforcement
has access to all information you provide to the staff of the
Division of Corporation Finance in connection with our review of
your
filing or in response to our comments on your filing.
We will consider a written request for acceleration of the
effective date of the registration statement as a confirmation of
the
fact that those requesting acceleration are aware of their
respective
responsibilities under the Securities Act of 1933 and the
Securities
Exchange Act of 1934 as they relate to the proposed public
offering
of the securities specified in the above registration statement.
We
will act on the request and, pursuant to delegated authority,
grant
acceleration of the effective date.
We direct your attention to Rules 460 and 461 regarding
requesting acceleration of a registration statement. Please allow
adequate time after the filing of any amendment for further review
before submitting a request for acceleration. Please provide this
request at least two business days in advance of the requested
effective date.
You may contact Cindy Dalton at (202) 824-5308 or Brian
Cascio
at (202) 942-1791 if you have questions regarding comments on the
financial statements and related matters. Please contact Adelaja
Heyliger at (202) 824-5082 or me at (202) 942-1880 with any other
questions.
Sincerely,
Peggy A. Fisher
Assistant Director
cc (via fax): Thomas Poletti, Esq., Kilpatrick & Lockhart
Nicholson Graham, LLP. 310.552.5001
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Avtar Dhillon
Genetronics B