SEC Company Response from ADVANCED OPTICS ELECTRONICS INC (CIK 0001020657) — Jun 17, 2005
ADVANCED OPTICS ELECTRONICS INC (CIK 0001020657)
Date: June 17, 2005 · CIK: 0001020657 · Accession: 0001185185-05-000199
AI Filing Summary & Sentiment
File numbers found in text: 000-24511
Referenced dates: May 5, 2005
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SICHENZIA ROSS FRIEDMAN FERENCE LLP
1065 AVENUE OF THE AMERICAS NEW YORK NY 10018
TEL 212 930 9700 FAX 212 930 9725 EMAIL: INFO@SRFF.COM
June 15, 2005
Securities and Exchange Commission
450 Fifth Street, N.W.
Judiciary Plaza
Washington, D.C. 20549
Attn: Mr. Brian Cascio
Mr. Gary Todd
Mr. Patrick Enunwaonye
RE: ADVANCED OPTICS ELECTRONICS, INC.
FORM10-KSB FOR THE FISCAL YEAR ENDED DECEMBER 31, 2004
FILE NO.000-24511
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Ladies and Gentlemen:
We are special counsel to Advanced Optics Electronics, Inc., a Nevada
corporation (the "Company"). This letter responds to your letter dated May 5,
2005, relating to comments of the Staff in connection with the above-referenced
submission.
The responses to the Staff's comments are numbered to relate to the
corresponding comments in your letter. Where applicable, the revised pages or
sections of the Form 10-KSB have been referenced. The Company intends to file an
amended Form 10-KSB to include the revisions set forth below.
FORM 10-KSB FOR THE FISCAL YEAR DECEMBER 31, 2004
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Item 6. Management's Discussion and Analysis of Financial Condition and Results
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of Operations - Pages 13-16
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1. You have consolidated the Biomoda business. The nature of that
business is substantially different from that of your display
business. Accordingly, MD&A should present distinct discussion of the
results of operations, financial condition and liquidity for that
business. You should provide disclosure about the status of that
business and its plan of operation, including disclosure about how
that business is and will be financed. Going concern issues
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Securities and Exchange Commission
June 15, 2005
Page 2 of 24
applicable to that operation should also be fully discussed in expand
disclosure.
RESPONSE:
The proposed revision to the MD&A will include the following:
Beginning with the 2004 10-KSB, the Company has consolidated the financials of
Biomoda. This has been done in order to comply with FIN 46, a pronouncement that
became effective December 15, 2004. The nature of Biomoda's business is
substantially different from that of Advanced Optics Electronics, Inc.. The
following is a discussion of Biomoda's results of operations, financial
condition and liquidity. More information about Biomoda is available in
Biomoda's 2004 10-KSB which is accessible from the SEC website. The SEC website
(http://www.sec.gov) contains reports and information statements and other
--------------------
information regarding Biomoda and other companies that file materials with the
SEC electronically.
Our plan of operation for the next twelve months is to verify and refine our
assay, design our kit, prepare for clinical studies, and initiate a dialogue
with the FDA relative to our approval submission. The Company is relying on a
bridge financing arrangement with Advanced Optics Electronics, Inc., an
affiliated public company, and also intends to raise additional funds from its
effective Form SB-2 Registration Statement during the next six months. The
Company is currently leasing Laboratory equipment from Advanced Optics
Electronics, Inc. on a month to month basis and intends to purchase this
equipment when adequate funds are raised.
Our initial product is a diagnostic test for lung cancer that will be performed
out of body by using a sputum sample from the patient. Our test does not require
any invasive sample taking. The sample will be sent to a clinical lab where a
procedure will be performed to determine the presence, or not, of lung cancer or
precancerous cells. Our diagnostic test can be used for other cell samples and
we intend to create and market products to diagnose and screen for other
prevalent cancers such as breast, cervical, bladder, and colorectal. We have
determined that our initial markets will be among the developed nations of
Europe, and North America and Japan. This has been determined on the basis of
available healthcare delivery and payer infrastructure. Japan is leading the
world, in this area, and has instituted a nationwide lung cancer-screening
program.
Since inception, Biomoda has funded operations primarily through private
placement of equity securities to third parties and to ADOT and loans from
Advanced Optics Electronics, Inc. As of December 31, 2004 it had raised net
proceeds of approximately $2,175,199, of which approximately $363,845 was
invested and or loaned by ADOT in 1998. On May 1, 2002, Biomoda entered into a
line of credit agreement (the "Agreement") with Advanced Optics Electronics,
Inc., an affiliated entity, ("Advanced Optics") with an annual interest rate of
5%. On May 1, 2003 the agreement was extended.
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Securities and Exchange Commission
June 15, 2005
Page 3 of 24
Biomoda had negative cash flows of $3,387 for the year ended December 31, 2004
resulting from $550,929 used in Biomoda's operating activities, $77,922 used in
Biomoda's investing activities and $625,464 of cash provided by financing
activities. Cash used in operating activities of $550,929 for the year ended
December 31, 2004 was primarily due to $708,380 in operating expenses, of which
$106,139 is General and Administrative, $436,899 is Research and Development and
$134,218 is professional fees. Cash used in investing activities of $77,922 for
the year ended December 31, 2004 was primarily due to payments for patents and
intangibles. Cash provided by financing activities of $625,464 for the year
ended December 31, 2004 was due to the proceeds from a line of credit from an
affiliated entity.
Biomoda has recorded no revenue from its inception through December 31, 2004.
The accumulated deficit is $1,181,458. In 2004, the net loss was $758,945 and
since inception, it is $2,476,489. The loss from operations was $708,380 in 2004
and $2,336,294 since inception. Most of its expense is related to product
development. Product development expenses consist primarily of personnel
expenses, consulting fees and lab expenses. Research development and technical
costs were $436,899 in 2004 and $1,420,700 since inception. We believe, however,
that continued investment in product development is critical to attaining our
strategic objectives and, as a result, expect product development expenses to
increase significantly in future periods. Biomoda expenses product development
costs as they are incurred.
General and administrative expenses consist of expenses for executive and
administrative personnel, facilities, professional services, travel and general
corporate activities. General and administrative costs were $106,139 in 2004 and
$332,927 since inception. We expect general and administrative costs to increase
in the future as our business matures and develops.
Biomoda's total assets are $225,371 at December 31, 2004. Of this, $206,577 is
patent costs, net of accumulated amortization of $55,793. Its liabilities of
1,341,664 primarily consist of its debt to Advanced Optics of $975,165 and
advances from shareholders of $134,988. Stockholders' deficit as of December 31,
2004 is $1,116,293.
Subsequent to December 31, 2004 and pursuant to a registration statement on Form
SB-2 (the "Registration Statement") under the Securities Act of 1933, as
amended, the Company is offering for sale up to 6,000,000 shares of its common
stock at a price of $3 per share. The Registration Statement was declared
effective on February 11, 2005. The Offering will terminate on the earlier of
February 11, 2008 or the date on which the maximum number of shares have been
sold.
Going Concern
-------------
Biomoda has been in the development stage since it began operations on January
3, 1990 and has not generated any revenues from operations and there is no
assurance of any future revenues. As of December 31, 2004, Biomoda had
accumulated deficit of approximately $2,476,000 and a working capital deficit of
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Securities and Exchange Commission
June 15, 2005
Page 4 of 24
approximately $1,337,000. In addition, Biomoda did not generate any cash from
operations and had no cash reserve dedicated to fund expenditures. These factors
create an uncertainty as to Biomoda's ability to continue as a going concern.
2. As a related matter, we are aware that start-up medical device
companies face significant uncertainties and that the FDA approval
process can consume substantial sums and take years to complete. Your
expanded disclosure should more clearly address that status of this
business and the inherent risks and substantial uncertainties.
RESPONSE:
The MD&A will be revised to include the following:
Management expects to continue assay validation work and seek to register its
product with the FDA in 2005. There are several business models, product types
and regulatory routes that Biomoda is evaluating including: ASR, 510K, PMA and
IVD kits.
ASR: This is the FDA designation for Analyte Specific Reagent. There are
generally two classes: Class I & Class II. Class I is considered to the lowest
risk. Biomoda's ASR product is a Class I and only requires registration and
meeting the FDA standards. This product is viewed as a component for an assay
developed in-house by Medical Reference Laboratories.
510K: This is the FDA designation for approvals that are based on "Substantial
Equivalence" with previously approved products and does require approval prior
to marketing. There are generally three classes: Class I, Class II, & Class III.
Depending on the indication established with the FDA, Biomoda's product will
either be Class I or Class II, if Biomoda proceeds with this product approval
route. This product will be a kit developed to determine the presence of
abnormal cells and a body fluid sample.
PMA: This is the FDA designation for approvals for new product indications (no
Substantial Equivalence) and does require approval prior to marketing. There are
generally two classes: Class II, & Class III. If Biomoda proceeds with this
approval route, Biomoda's expects this product to be Class III due to indication
of diagnostic for a specific cancer.
IVD: This is an industry designation for In Vitro Diagnostic. Products in the
industry are either reagents or kits. Kits include the key components required
to conduct the assay for the specific indication stated in the package insert.
Reagents are single components used in assays developed by a Reference Labs. The
lab will be required to have met the FDA CLIA (current Clinical Laboratory
Improvement Act) regulations to market a diagnostic.
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Securities and Exchange Commission
June 15, 2005
Page 5 of 24
Biomoda is evaluating several cancers with a focus on large markets that are in
need of the most immediate diagnostic support. These include: lung, bladder and
cervical.
Our products are subject to FDA registration or approval and to post-approval
FDA reporting requirements.
Costs in complying with regulatory and legislative matters such as the Clinical
Laboratory Improvement Amendment of 1988 (CLIA), which regulates the quality and
reliability of medical testing in the U.S., adverse changes in zoning laws, tax
laws, or other laws affecting the medical and diagnostic industry may prove to
be a major obstacle, both in respect of time and costs in our research and
development.
The timing of regulatory filings and approvals, if any, for the Company's
products are made less certain by the Company's strategy of seeking one or more
collaborative arrangements with development and marketing partners, which may
require that a collaborative partner be responsible for seeking and obtaining
regulatory approvals either in foreign countries or in the U.S. Biomoda intends
to market its products throughout the world. There are numerous regulatory
agencies that regulate the sale of diagnostic and therapeutic products, and
these agencies may be affected or influenced by criteria materially different
than those of the FDA. The sale of Biomoda's products may be materially affected
by the policies of these regulatory agencies or the domestic politics of the
countries involved. Biomoda has not applied for and does not now have the
approval of any foreign country to sell its products for diagnostic or
therapeutic use.
Biomoda's lung cancer product validation is projected to be complete by year-end
and a contract manufacturing relationship is projected to be established by
year-end. Based on these benchmarks, ASR registration and product listing can be
completed by that time also. At that juncture reagent sales can begin. This is
estimated to cost an additional $500,000.
Class I/II 510K can be completed as judged appropriate for the business and will
require approximately 6 to 9 months effort to prepare documentation and receive
FDA approval. During that time kit manufacturing can be initiated. Partial
funding will be provided from reagent sales revenue. It is estimated additional
funding of $300,000 will be required.
PMA will require clinical studies to be completed and will be initiated when it
is viewed as appropriate for the business. This will require on the order of 18
months to plan, execute, and document. During that time kit manufacturing can be
initiated. FDA approval will require 6 to 9 months. Partial funding will be
provided from reagent sales. It is estimated additional funding of $2 million
will be required.
Biomoda's current intention regarding regulatory strategy, is to initiate
product introductions via an ASR registration and potentially migrate up the
regulatory spectrum as markets require.
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Securities and Exchange Commission
June 15, 2005
Page 6 of 24
3. With respect to the display business, expand to present a detailed
description of your plan of operation for the next twelve months. This
description should include such matters as:
a. a discussion of how long you can satisfy your cash requirements
and whether you will have to raise additional funds in the next
twelve months;
b. a summary of any product research and development that you will
perform for the term of the plan; c. whether you expect your
products will be finalized and ready for market (and, if not when
they will be ready);
d. any expected purchase or sale of plant and significant equipment;
and
e. any expected significant changes in the number of employees.
The expanded discussion should also present more specific detail about your
viable plan to continue as a going concern. This discussion should be specific
with regard to time frames, funding needs and sources and other matters, that
impact your ability to complete the plan. The impact if you are not successful
with these efforts should also be addressed. Refer to FRC 607.02. Refer also to
Regulation S-B Item 303(a).
RESPONSE:
We propose the following revision of the plan of operation in MD&A:
As of March 31, 2005, the Company had a marketable securities portfolio valued
at $1,935,050. The Company's monthly burn-rate, the amount of money spent each
month, is approximately $170,000. This represents approximately 12 months of
operating funds. The Company is actively pursuing potential financing options as
it looks to secure additional funds to both stabilize and grow its business
operations. Management will review any financing options at