GeoVax Labs, Inc. - Annual Report: 2006 (Form 10-K)
UNITED
STATES SECURITIES AND EXCHANGE COMMISSION
Washington,
D.C. 20549
FORM
10-K
X |
Annual
Report pursuant to Section 13 or 15(d) of the Securities Exchange
Act of
1934.
|
For
fiscal year ended December 31, 2006
___ |
Transition
Report pursuant to Section 13 or 15(d) of the Securities Exchange
Act of
1934.
|
Commission
File No. 000-52091
GEOVAX
LABS, INC.
(Exact
name of Registrant as specified in its charter)
Illinois
|
87-0455038
|
(State
or other jurisdiction of incorporation or organization)
|
(IRS
Employer Identification Number)
|
1256
Briarcliff Road NE
Atlanta,
GA
|
30306
|
(Address
of principal executive offices)
|
(Zip
Code)
|
Registrant’s
telephone number, including area code:
(404)
727-0971
Securities
registered pursuant to Section 12(g) of the Act:
Common
Stock $.001 par value
Indicate
by check mark if the registrant is a well-known seasoned issuer, as defined
in
Rule 405 of the Securities Act.
Yes
No X
Indicate
by check mark if the registrant is not required to file reports pursuant to
Section 13 or Section 15(d) of the Act.
Yes
No X
Indicate
by check mark whether the Registrant (1) has filed all reports required to
be
filed by Section 13 or 15(d) of the Securities Exchange Act of 1934 during
the
preceding 12 months (or for such shorter period that the Registrant was required
to file such reports), and (2) has been subject to such filing requirements
for
the past 90 days.
(1)
Yes
No X
Indicate
by check mark if disclosure of delinquent filers pursuant to Item 405 of
Regulation S-K (§ 229.405 of this chapter) is not contained herein, and will not
be contained, to the best of registrant’s knowledge, in definitive proxy or
information statements incorporated by reference in Part III of this Form 10-K
or any amendment to this Form 10-K. [ ]
Indicate
by check mark whether the registrant is a large accelerated filer, an
accelerated filer or a non-accelerated filer. See definition of “accelerated
filer and large accelerated filer” in Rule 12b-2 of the Exchange Act. (Check
one):
Large
accelerated filer o
|
Accelerated
filer o
|
Non-accelerated
filer x
|
Indicate
by check mark whether the registrant is a shell company (as defined in Rule
12b-2 of the Act).
Yes
No X
The
aggregate market value of common stock held by non-affiliates of the Registrant
on June 30, 2006, the last business day of the Registrant’s most recently
completed second fiscal quarter, based on the closing price on that date of
$0.65, was $63,733,495.
As
of
March 23, 2007, the number of Shares of the Registrant’s Common Stock, $.001 par
value, is 712,834,703 issued and outstanding.
Documents
Incorporated by Reference
The
proxy
statement of the Registrant with respect to its 2007 Annual Meeting of
Shareholders is incorporated by reference in Part III.
2
GEOVAX
LABS, INC.
Table
of Contents
PART
I
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||
Item
1
|
Business
|
4
|
Item
1A
|
Risk
Factors
|
9
|
Item
1B
|
Unresolved
Staff Comments
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15
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Item
2
|
Properties
|
15
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Item
3
|
Legal
Proceedings
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15
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Item
4
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Submission
of Matters to Vote of Security Holders
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15
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PART
II
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||
Item
5
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Market
for Registrant’s Common Equity and Related Shareholder
Matters
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15
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Item
6
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Selected
Financial Data
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17
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Item
7
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Management’s
Discussion and Analysis of Financial Condition and Results of
Operations
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18
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Item
7A
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Quantitative
and Qualitative Disclosures about Market Risk
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21
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Item
8
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Financial
Statements and Supplementary Data
|
21
|
Item
9
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Changes
in and Disagreements with Accountants on Accounting or Financial
Disclosure
|
21
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Item
9A
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Controls
and Procedures
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22
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Item
9B
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Other
Information
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22
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PART
III
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||
Item
10
|
Directors,
Executive Officers and Corporate Governance
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22
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Item
11
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Executive
Compensation
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23
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Item
12
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Security
Ownership of Certain Beneficial Owners and Management and Related
Shareholder Matters
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23
|
Item
13
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Certain
Relationships and Related Party Transactions, and Director
Independence
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23
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Item
14
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Principal
Accountant Fees and Services
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23
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PART
IV
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||
Item
15
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Exhibits
and Financial Statement Schedules
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23
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Signatures
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26
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Exhibit
Index
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27
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3
“SAFE
HARBOR” STATEMENT UNDER THE
PRIVATE
SECURITIES LITIGATION REFORM ACT OF 1995
From
time to time, we make oral and written statements that may constitute
“forward-looking statements” (rather than historical facts) as defined in the
Private Securities Litigation Reform Act of 1995 or by the Securities and
Exchange Commission, or SEC, in its rules, regulations and releases, including
Section 27A of the Securities Act of 1933, as amended and Section 21E of the
Securities Exchange Act of 1934, as amended. We desire to take advantage of
the
“safe harbor” provisions in the Private Securities Litigation Reform Act of 1995
for forward-looking statements made from time to time, including, but not
limited to, the forward-looking statements made in this Annual Report on Form
10-K, as well as those made in other filings with the SEC.
All
statements in this Annual Report, including in “Management’s Discussion and
Analysis of Financial Condition and Results of Operations,” other than
statements of historical fact are forward-looking statements for purposes of
these provisions, including any projections of financial items, any statements
of the plans and objectives of management for future operations, any statements
concerning proposed new products or services, any statements regarding future
economic conditions or performance, and any statement of assumptions underlying
any of the foregoing. In some cases, forward-looking statements can be
identified by the use of terminology such as “may,” “will,” “expects,” “plans,”
“anticipates,” “estimates,” “potential” or “could” or the negative thereof or
other comparable terminology. Although we believe that the expectations
reflected in the forward-looking statements contained herein and in documents
incorporated by this Annual Report are reasonable, there can be no assurance
that such expectations or any of the forward-looking statements will prove
to be
correct, and actual results could differ materially from those projected or
assumed in the forward-looking statements.
Our
future financial condition and results of operations, as well as any
forward-looking statements, are subject to inherent risks and uncertainties,
including but not limited to the risk factors set forth under the heading “Risk
Factors” in this Annual Report, and including risks or uncertainties regarding
the clinical testing required by regulatory authorities for products under
development; the need for future clinical testing of our products under
development; the significant time and expense that will be incurred in
developing any of the potential commercial applications for our products; our
ability to obtain capital to fund our current and future operations; and risks
relating to the enforceability of any patents covering our products and to
the
possible infringement of third party patents by those products. All
forward-looking statements and reasons why results may differ included in this
Annual Report are made as of the date hereof, and we assume no obligation to
update any such forward-looking statement or reason why actual results might
differ.
PART
I
Item
1.
|
Description
of Business
|
GeoVax
Labs, Inc. (“GeoVax” or the “Company”), is a clinical stage biotechnology
company engaged in research and development activities with a mission to
develop, license and commercialize the manufacture and sale of human vaccines
for diseases caused by Human Immunodeficiency Virus (“HIV”) and other infectious
agents. The Company has exclusively licensed from Emory University certain
Acquired Immune Deficiency Syndrome (“AIDS”) vaccine technology which was
developed in collaboration with the National Institutes of Health and the
Centers for Disease Control and Prevention.
Merger
Between Dauphin Technology, Inc. and GeoVax, Inc.
GeoVax
was originally incorporated under the laws of Illinois as Dauphin Technology,
Inc. (“Dauphin”) on June 6, 1988. Until December 2003, Dauphin marketed mobile
hand-held, pen-based computers and broadband set-top boxes and provided private,
interactive cable systems to the extended stay hospitality industry. The Company
was unsuccessful and its operations were terminated in December 2003.
On
September 28, 2006, Dauphin completed a merger (the “Merger”) with GeoVax, Inc.
Pursuant to the Agreement and Plan of Merger, GeoVax, Inc. merged with and
into
GeoVax Acquisition Corp., a wholly-owned subsidiary of Dauphin. As a result
of
the Merger, the shareholders of GeoVax, Inc. exchanged their shares of common
stock for Dauphin common stock and GeoVax, Inc. became a wholly-owned subsidiary
of Dauphin. In connection with the Merger, Dauphin changed its name to GeoVax
Labs, Inc., replaced most of its officers and directors with those of GeoVax,
Inc. and moved its offices to Atlanta, Georgia. The Company currently does
not
plan to conduct any business other than GeoVax, Inc.’s business of developing
new products for the treatment or prevention of human diseases.
4
The
Merger was accounted for under the purchase method of accounting as a reverse
acquisition in accordance with U.S. generally accepted accounting principles
for
accounting and financial reporting purposes. Under this method of accounting,
Dauphin was treated as the “acquired” company. In accordance with guidance
applicable to these circumstances, the Merger was considered to be a capital
transaction in substance. Accordingly, for accounting purposes, the Merger
was
treated as the equivalent of GeoVax, Inc. issuing stock for the net monetary
assets of Dauphin, accompanied by a recapitalization. The net monetary assets
of
Dauphin (consisting only of cash) were stated at their fair values, essentially
equivalent to historical costs, with no goodwill or other intangible assets
recorded. The deficit accumulated during the development stage of GeoVax, Inc.
was carried forward after the Merger. The consolidated financial statements
included in this Annual Report on Form 10-K reflect the operations of GeoVax,
Inc. prior to the Merger, and of the combined company subsequent to the
Merger.
Overview
of AIDS
AIDS
is
considered by many in the scientific and medical community to be the most lethal
infectious disease in the world. According to the 2006 Report on the Global
AIDS
Epidemic published by UNAIDS (the Joint United Nations Programme on HIV/AIDS);
the number of people living with HIV continues to grow, from 35 million in
2001
to approximately 38 million in 2005, the most recent year reported.
Approximately 25 million people have died since the first cases of AIDS were
identified in 1981 and, during 2005; approximately four million people became
newly infected with HIV. According to an International AIDS Vaccine Research
Institute (IAVI) report dated June 13, 2005, the global market for a safe and
effective AIDS vaccine has been estimated at approximately $4 billion or
greater.
The
standard approach to treating HIV infection has been to lower viral loads by
using drugs, reverse transcriptase inhibitors (“RTIs”) and protease inhibitors
(“PIs”), or a combination of these drugs, to inhibit two of the viral enzymes
that are necessary for the virus to reproduce. The cost of these drugs range
from $12,000 to $60,000 per year. However, HIV is prone to genetic changes
that
can produce strains of HIV that are resistant to currently approved RTIs and
PIs. Generally, HIV that is resistant to one drug within a class is likely
to
become resistant to the entire class, meaning that it may be impossible to
re-establish suppression of a genetically altered strain by substituting
different RTI and PI combinations. Furthermore, these treatments continue to
have significant limitations, such as viral resistance, toxicity and patient
non-adherence to the complicated treatment regimens. As a result, over time,
many patients develop intolerance to these medications or simply give up taking
the medications due to the side effects and the difficult dosing
regimens.
According
to International AIDS Vaccine Initiative, the cost and complexity of new
treatment advances for AIDS puts them out of reach for most people in the
countries where treatment is needed the most and as noted above, in
industrialized nations, where drugs are more readily available, side effects
and
increased rates of viral resistance have raised concerns about their long term
use. AIDS vaccines, therefore, are seen by many as the most promising way to
end
the HIV/AIDS pandemic. It is expected that vaccines for HIV/AIDS, once
developed, will be used internationally by any organization that provides health
care services, including hospitals, medical clinics, the military, prisons
and
schools.
HIV
infection severely damages the immune system, the body’s defense against
disease. HIV infects and gradually destroys T-cells and macrophages, both white
blood cells that play key roles in protecting humans against infectious disease
caused by viruses, bacteria, fungi, yeast and other micro-organisms.
Opportunistic infections by organisms, normally posing no problem for control
by
a healthy immune system, can ravage persons with immune systems damaged by
HIV.
Destruction of the immune system occurs over years. The average onset of AIDS,
the final stage of HIV infection, usually occurs after eight to 10 years of
HIV
infection.
AIDS
Vaccines Being Developed by the Company
There
are
several AIDS-causing HIV-1 virus subtypes that are found in different regions
of
the world. The three most prevalent subtypes are A, B and C. The predominant
subtype found in Europe, North America, South America, Japan and Australia
is B,
whereas the predominant subtypes in Africa are A, B and C and in India the
predominant subtype is C. Each subtype is at least 20% different in its genetic
sequence from other subtypes. These differences may mean that vaccines against
one subtype may be only partially effective against other subtypes, although
this is not yet certain. GeoVax plans to develop regionally formulated AIDS
vaccines comprised of various preparations, depending on the HIV-1 subtype
prevalence in a geographic area of the world.
5
GeoVax’s
product development efforts to date have been focused on the development and
testing of our AIDS vaccine candidates which are based on DNA and rMVA
technologies that have been developed by Dr. Harriet Robinson of Emory
University and Chairperson of the GeoVax Scientific Advisory Board in
collaboration with scientists at the Centers for Disease Control and the
National Institutes of Health (NIH). These vaccines operate by stimulating
multi-protein T-cell and antibody responses against the AIDS virus in the
recipient.
Our
vaccines are comprised of two distinct vaccine components, DNA (deoxyribonucleic
acid) and rMVA (recombinant Modified Vaccinia Ankara) virus. Both the DNA and
the rMVA vaccines express multiple HIV-1 proteins in the vaccinated individual.
The DNA is used to prime the immune response, the efficacy of which is enhanced
by the rMVA vaccination, which boosts the immune response. We believe that
the
vaccines provide broad protection against a large segment of the AIDS virus,
thus preventing virus escape, large scale viral replication and the onset of
clinical signs of AIDS in the vaccinated individual.
Our
vaccines underwent efficacy trials in non-human primates for a period of over
42
months. In these pre-clinical trials, 22 out of 23 monkeys were protected
against AIDS while 5 out of 6 non-vaccinated control animals died of clinical
AIDS. Following these animal trials, our vaccines were approved for Phase I
trials in humans by the U.S. Food and Drug Administration (“FDA”). (See
“Government Regulation” below for an explanation of how clinical trials are
conducted.)
A
Phase I
clinical study in humans, evaluating our DNA-AIDS vaccine for safety began
in
January 2003 and was satisfactorily concluded in June 2004. This trial was
conducted by the HIV Vaccine Trials Network (HVTN), a division of
NIAID-NIH.
The
start
of a series of four additional human trials evaluating our AIDS vaccines at
four
locations in the United States began in April 2006. These Phase Ia/Ib human
trials are designed to determine if our vaccines are safe and will stimulate
the
level of immune responses (T-cell and antibody) that may protect against the
development of clinical signs of AIDS. Increasing numbers of people will be
included in each successive trial in the series. These trials are intended
to
provide human data that indicates our vaccine is safe and that it has the
capability to protect vaccinated individuals against the development of
AIDS.
One
trial
started in April 2006 and a second trial began in September 2006 with two
additional trials scheduled to begin in mid-2007. Early reported results from
both the April 2006 trial [individuals received only 1/10th dose of GeoVax
vaccines] and the Sept 2006 trial [individuals received full dose of GeoVax
vaccines] indicate our vaccines are stimulating anti-AIDS virus immune responses
in the majority of vaccinated individuals. Additional human trials with 60-70
people evaluating various vaccine dose administration regimes and conducted
by
the HVTN are scheduled to begin in mid-2007.
Due
to
this early and promising positive human vaccine response data from the April
2006 and September 2006 trials, the HVTN, together with GeoVax, have accelerated
their plans to conduct Phase II human trials on our AIDS vaccines by a year
or
more. A tentative start date for these Phase II trials is the end of 2007/early
2008.
Government
Regulation
Regulation
by governmental authorities in the United States and other countries is a
significant factor in our ongoing research and development activities and in
the
manufacture of our products under development. Complying with these regulations
involves a considerable amount of time and expense.
In
the
United States, drugs are subject to rigorous federal regulation and, to a lesser
extent, state regulation. The Federal Food, Drug and Cosmetic Act, as amended
(the “FDC
Act”),
and
the regulations promulgated thereunder, and other federal and state statutes
and
regulations govern, among other things, the testing, manufacture, safety,
efficacy, labeling, storage, record keeping, approval, advertising and promotion
of medications and medical devices. Product development and approval within
this
regulatory framework is difficult to predict, takes a number of years and
involves great expense.
The
steps
required before a pharmaceutical agent may be marketed in the United States
include:
· |
pre-clinical
laboratory tests, in vivo pre-clinical studies and formulation studies;
|
· |
the
submission to the FDA of an Investigational New Drug Application
(IND) for
human clinical testing which must become effective before human clinical
trials can commence;
|
· |
adequate
and well-controlled human clinical trials to establish the safety
and
efficacy of the product;
|
6
· |
the
submission of a New Drug Application to the FDA;
and
|
· |
FDA
approval of the New Drug Application prior to any commercial sale
or
shipment of the product.
|
Each
of
these steps is described further below.
In
addition to obtaining FDA approval for each product, each domestic manufacturing
establishment must be registered with, and approved by, the FDA. Domestic
manufacturing establishments are subject to biennial inspections by the FDA
and
must comply with the FDA's Good Manufacturing Practices for products, drugs
and
devices.
Pre-clinical
Trials - Pre-clinical
testing includes laboratory evaluation of chemistry and formulation, as well
as
cell culture and animal studies to assess the potential safety and efficacy
of
the product. Pre-clinical safety tests must be conducted by laboratories that
comply with FDA regulations regarding Good Laboratory Practices. The results
of
pre-clinical testing are submitted to the FDA as part of the IND application
and
are reviewed by the FDA prior to the commencement of human clinical trials.
Unless the FDA objects to an IND, the IND becomes effective 30 days following
its receipt by the FDA.
Clinical
Trials - Clinical
trials involve the administration of the AIDS vaccines to healthy volunteers
or
to patients under the supervision of a qualified principal investigator.
Clinical trials are conducted in accordance with the FDA’s
Good
Clinical Practices standard under protocols that detail the objectives of the
study, the parameters to be used to monitor safety and the efficacy criteria
to
be evaluated. Each protocol must be submitted to the FDA as part of the IND.
Further, each clinical study must be conducted under the auspices of an
independent institutional review board at the institution where the study will
be conducted. The institutional review board will consider, among other things,
ethical factors, the safety of human subjects and the possible liability of
the
institution.
Clinical
trials are typically conducted in three sequential phases, but the phases may
overlap. In Phase I, the initial introduction of the product into healthy human
subjects, the drug is tested for safety (adverse side effects), absorption,
dosage tolerance, metabolism, bio-distribution, excretion and pharmacodynamics
(clinical pharmacology). Phase II is the proof of principal stage and involves
studies in a limited patient population in order to determine the efficacy
of
the product for specific, targeted indications, determine dosage tolerance
and
optimal dosage and identify possible adverse side effects and safety risks.
When
there is evidence that the product may be effective and has an acceptable safety
profile in Phase II evaluations, Phase III trials are undertaken to further
evaluate clinical efficacy and to test for safety within an expanded patient
population at geographically dispersed multi-center clinical study sites. The
manufacturer or the FDA may suspend clinical trials at any time if either
believes that the individuals participating in the trials are being exposed
to
unacceptable health risks.
New
Drug Application and FDA Approval Process - The
results and details of the pre-clinical studies and clinical studies are
submitted to the FDA in the form of a New Drug Application. If the New Drug
Application is approved, the manufacturer may market the product in the United
States.
International
Approval - Whether
or not the FDA has approved the drug, approval of a product by regulatory
authorities in foreign countries must be obtained prior to the commencement
of
commercial sales of the drug in such countries. The requirements governing
the
conduct of clinical trials and drug approvals vary widely from country to
country, and the time required for approval may be longer or shorter than that
required for FDA approval.
Other
Regulations
In
addition to FDA regulations, our business activities may also be regulated
by
the Occupational Safety and Health Act, the Environmental Protection Act, the
Toxic Substances Control Act, the Resource Conservation and Recovery Act and
other present and potential future federal, state or local regulations.
Violations of regulatory requirements at any stage may result in various adverse
consequences, including regulatory delay in approving or refusal to approve
a
product, enforcement actions, including withdrawal of approval, labeling
restrictions, seizure of products, fines, injunctions and/or civil or criminal
penalties. Any product that we develop must receive all relevant regulatory
approvals or clearances before it may be marketed.
Competition
FDA
and
other regulatory approvals of our vaccines have not yet been obtained and we
have not yet generated any revenues from product sales. Our future competitive
position depends on our ability to obtain FDA and other regulatory approvals
of
our vaccines and to license or sell the vaccines to third parties on favorable
terms.
7
Overall,
the biopharmaceutical industry is competitive and subject to rapid and
substantial technological change. There are many companies and individuals
conducting research and development activities in the area of HIV/AIDS vaccines,
all of which may compete with us. Developments by others may render our proposed
vaccination technologies noncompetitive or obsolete, or we may be unable to
keep
pace with technological developments or other market factors. Technological
competition in the industry from pharmaceutical and biotechnology companies,
universities, governmental entities and others diversifying into the field
is
intense and is expected to increase. Many of the pharmaceutical companies that
compete with us are large, multinational corporations, such as Merck & Co.,
Chiron Inc. and Aventis-Pasteur that have significantly greater research and
development capabilities than us, as well as substantially more marketing,
manufacturing, financial and managerial resources. In addition, acquisitions
of,
or investments in, small pharmaceutical or biotechnology companies by such
large
corporations could increase their research, financial, marketing, manufacturing
and other resources. Competitor technologies may ultimately prove to be safer,
more effective or less costly than any vaccine that we develop. There currently
is no FDA licensed and commercialized AIDS vaccine or competitive vaccine
available in the world market.
Intellectual
Property
We
are
the exclusive, worldwide licensee of several patents and other technologies
(the
“Emory Technology”) owned or otherwise controlled by Emory University (“Emory”)
pursuant to a License Agreement originally entered into on August 23, 2002
and
restated on June 23, 2004 (the “License Agreement”). The License Agreement
expires on the expiration date of the last to expire of the patents licensed
thereunder. Currently several of these patents are approved, but not issued
by
the Patent and Trademark Office (“PTO”), with several patents pending in other
countries, thus until such patents are issued, we will not know the final
termination date of the License Agreement.
We
may
not use the Emory Technology for any purpose other than the purposes permitted
by the License Agreement, allow any person to access or use the Emory Technology
or advertise, market, sell or distribute the Emory Technology. Emory also
reserved the right to use the Emory Technology for research, educational and
non-commercial clinical purposes. Due to the use of federal funds in the
development of the Emory Technology, the United States Government has the
irrevocable, royalty-free, paid-up right to practice and have practiced certain
patents throughout the world, should it choose to exercise such
rights.
We
are
also the exclusive licensee of five patents from MFD, Inc. (the “MFD
Patents”)
pursuant to a license agreement dated December 26, 2004 (the “MFD
License Agreement”),
related to certain manufacturing processes. Pursuant to the MFD License
Agreement, we obtained a fully paid, worldwide, irrevocable, exclusive license
in and to the MFD Patents to use, market, offer for sale, sell, lease and import
for any AIDS and smallpox vaccine made with GeoVax technology and non-exclusive
rights for other products. The term of the MFD License Agreement ends on the
expiration date of the last to expire of the MFD Patents. These patents expire
in 2017 through 2019.
We
are
also a non-exclusive licensee of four patents owned by the NIH. The license
agreement with NIH (the “NIH
License Agreement”)
was
entered into on July 10, 2003 and subsequently amended on April 7, 2004.
Pursuant to the NIH License Agreement, we licensed the patent rights and certain
materials for the purpose of laboratory experiments conducted to evaluate the
suitability for commercial development of the patent rights and materials.
The
NIH License Agreement is expected to continue on an annual renewable
basis.
We
cannot
be certain that any of the current pending patent applications we have licensed,
or any new patent applications we may file or license, will ever be issued
in
the United States or any other country. Even if issued, there can be no
assurance that those patents will be sufficiently broad to prevent others from
using our products or processes. Furthermore, our patents, as well as those
we
have licensed or may license in the future, may be held invalid or unenforceable
by a court, or third parties could obtain patents that we would need to either
license or to design around, which we may be unable to do. Current and future
competitors may have licensed or filed patent applications or received patents,
and may acquire additional patents and proprietary rights relating to products
or processes competitive with ours.
In
addition to patent protection, we also attempt to protect our proprietary
products, processes and other information by relying on trade secrets and
non-disclosure agreements with our employees, consultants and certain other
persons who have access to such products, processes and information. Under
the
agreements, all inventions conceived by employees are our exclusive property.
Nevertheless, there can be no assurance that these agreements will afford
significant protection against misappropriation or unauthorized disclosure
of
our trade secrets and confidential information.
8
Manufacturing
We
do not
have the facilities or expertise to manufacture any of the clinical or
commercial supplies of any of our products. To be successful, our products
must
be manufactured in commercial quantities in compliance with regulatory
requirements and at an acceptable cost. To date, we have not commercialized
any
products, nor have we demonstrated that we can manufacture commercial quantities
of our product candidates in accordance with regulatory requirements. If we
cannot manufacture products in suitable quantities and in accordance with
regulatory standards, either on our own or through contracts with third parties,
it may delay clinical trials, regulatory approvals and marketing efforts for
such products. Such delays could adversely affect our competitive position
and
our chances of achieving profitability. We cannot be sure that we can
manufacture, either on our own or through contracts with third parties, such
products at a cost or in quantities, which are commercially viable. We currently
rely and intend to continue to rely on third-party contract manufacturers to
produce materials needed for research, clinical trials and, ultimately, for
product commercialization.
Previous
Operations
Prior
to
the Merger on September 28, 2006, the Company operated under the name Dauphin
Technology, Inc. The discussion below describes the operations of the Company
prior to the Merger. Effective with the Merger, our operations became those
of
GeoVax, Inc., a company in operation since 2001, with a separate management
from
Dauphin Technology, Inc.. The rest of this Annual Report describes the
operations and activities associated with GeoVax, Inc. both prior to, and
subsequent to, the Merger.
The
Company was originally formed in 1988 to engage in the computer business. In
1993 and 1994, we encountered severe financial problems, and on January 3,
1995,
we filed a petition for relief under Chapter 11 of the Federal Bankruptcy Code
in the United States Court for the Northern District of Illinois, Eastern
Division. The Company operated under Chapter 11 until July 23, 1996, when it
was
discharged as Debtor-in-Possession and bankruptcy proceedings were
closed.
Following
its emergence from bankruptcy, the Company was primarily engaged in designing
and marketing mobile hand-held, pen-based computers and set-top boxes. We also
were a provider of private, interactive cable systems to the extended stay
hospitality industry. One of our subsidiaries also performed design services,
specializing in hardware and software development, to customers in the
communications, computer, video, and automotive industries. We were unsuccessful
in these operations and terminated all operations in December 2003. From
December 2003 until consummation of the merger with Geovax, Inc. in September
2006, the Company was inactive.
Research
and Development
Our
expenditures for research and development activities by GeoVax, Inc. prior
to
September 28, 2006 and by GeoVax Labs, Inc. subsequent thereto were
approximately $666,000, $1,641,000 and $2,267,000 during the years ended
December 31, 2006, 2005 and 2004, respectively. No amounts were spent by Dauphin
on research and development during this time period. As our vaccines continue
to
go through the process to obtain regulatory approval, we expect our research
and
development costs to continue to increase significantly as even larger human
trials proceed in the United States and foreign countries.
Employees
As
of
December 31, 2006, we had eight employees.
Item
1A. Risk
Factors
If
any of
the following risks actually occur, our business or prospects could be
materially adversely affected. You should also refer to the other information
in
this Annual Report on Form 10-K, including our financial statements and the
related notes.
9
We
are a development stage company and, other than research and development, have
no other operations.
We
are a
development stage company and, other than our research and development
activities, have no other operations. Our products are not ready for sale.
These
factors raise substantial doubt about our ability to continue in business.
During the fiscal year ended December 31, 2006, we had a net loss of $584,166
and a net loss since inception of $6,283,613.
Our
products are still being developed and are unproven. These products may not
be
successful.
In
order
to become profitable, we must generate revenue through sales of our products,
however our products are in varying stages of development and testing. Our
products have not been proven in human research trials and have not been
approved by any government agency for sale. If we cannot successfully develop
and prove our products, and if we do not develop other sources of revenue,
we
will not become profitable and at some point we would discontinue
operations.
We
have sold no products or generated any revenues and we do not anticipate any
significant revenues to be generated in the foreseeable
future.
We
have
conducted pre-clinical trials and are conducting clinical trials and will
continue to do so for several more years before we are able to commercialize
our
technology. There can be no assurance that we will ever generate significant
revenues.
Our
business will require continued funding. If we do not receive adequate funding,
we may not be able to continue our operations.
To
date,
we have financed our operations principally through the private placement of
common and preferred stock. We will require substantial additional financing
at
various intervals for our operations, including for clinical trials, for
operating expenses including intellectual property protection and enforcement,
for pursuit of regulatory approvals and for establishing or contracting out
manufacturing, marketing and sales functions. There is no assurance that such
additional funding will be available on terms acceptable to us or at all. If
we
are not able to secure the significant funding that is required to maintain
and
continue our operations at current levels or at levels that may be required
in
the future, we may be required to severely curtail, or even to cease, our
operations.
We
are subject to the risks and uncertainties inherent in new businesses. Our
failure to plan or forecast accurately could have a material adverse impact
on
our development.
We
are
subject to the risks and uncertainties inherent in new businesses, including
the
following:
·
|
we
may not have enough money to develop our products and bring them
to
market;
|
·
|
we
may experience unanticipated development or marketing expenses, which
may
make it more difficult to develop our products and bring them to
market;
|
·
|
even
if we are able to develop products and bring them to market, we may
not
earn enough revenue from the sales of our products to cover the costs
of
operating our business.
|
If,
because of our failure to plan or project accurately, we are unsuccessful in
our
efforts to develop products or if the products we develop do not produce
revenues as anticipated, it is not likely we will ever become profitable and
we
may be required to curtail some or all of our operations.
Our
success will be dependent, in part, upon our President and Chief Executive
Officer, Donald Hildebrand and Harriet Robinson, our primary scientist. The
loss
of the services of either of these individuals would have an adverse effect
our
operations.
Our
success depends, to a significant degree, on our continued receipt of services
from our President and Chief Executive Officer, Mr. Donald G. Hildebrand, and
on
the research expertise of Dr. Harriet Robinson. The loss of services of either
of these individuals would have a material adverse effect on our business and
operations.
10
Regulatory
and legal uncertainties could result in significant costs or otherwise harm
our
business.
In
order
to manufacture and sell our products, we must comply with extensive
international and domestic regulation. In order to sell our products in the
United States, approval from the FDA is required. The FDA approval process
is
expensive and time-consuming. We cannot predict whether our products will be
approved by the FDA. Even if they are approved, we cannot predict the time
frame
for approval. Foreign regulatory requirements differ from jurisdiction to
jurisdiction and may, in some cases, be more stringent or difficult to obtain
than FDA approval. As with the FDA, we cannot predict if or when we may obtain
these regulatory approvals. If we cannot demonstrate that our products can
be
used safely and successfully in a broad segment of the patient population on
a
long-term basis, our products would likely be denied approval by the FDA and
the
regulatory agencies of foreign governments.
We
will face intense competition and rapid technological change that could result
in products that are superior to the products we will be commercializing or
developing.
The
market for vaccines that protect against HIV/AIDS is intensely competitive
and
is subject to rapid and significant technological change. We will have numerous
competitors in the United States and abroad, including, among others, large
companies such as Merck & Co. and Chiron Inc. These competitors may develop
technologies and products that are more effective or less costly than any of
our
future products or that could render our products obsolete or noncompetitive.
We
expect most of these competitors to have substantially more resources than
us.
In addition, the pharmaceutical industry continues to experience consolidation,
resulting in an increasing number of larger, more diversified companies than
us.
Among other things, these companies can spread their research and development
costs over much broader revenue bases than we can and can influence customer
and
distributor buying decisions.
Our
products may not gain market acceptance among physicians, patients, healthcare
payors and the medical community. Significant factors in determining whether
we
will be able to compete successfully include:
·
|
the
efficacy and safety of our
vaccines;
|
·
|
the
time and scope of regulatory
approval;
|
·
|
reimbursement
coverage from insurance companies and
others;
|
·
|
the
price and cost-effectiveness of our products;
and
|
·
|
patent
protection.
|
Our
product candidates are based on new technology and, consequently, are inherently
risky. Concerns about the safety and efficacy of our products could limit our
future success.
We
are
subject to the risks of failure inherent in the development of product
candidates based on new technologies. These risks include the possibility that
the products we create will not be effective, that our product candidates will
be unsafe or otherwise fail to receive the necessary regulatory approvals or
that our product candidates will be hard to manufacture on a large scale or
will
be uneconomical to market.
Many
pharmaceutical products cause multiple potential complications and side effects,
not all of which can be predicted with accuracy and many of which may vary
from
patient to patient. Long term follow-up data may reveal additional complications
associated with our products. The responses of potential physicians and others
to information about complications could materially affect the market acceptance
of our products, which in turn would materially harm our business.
Unsuccessful
or delayed regulatory approvals required to exploit the commercial potential
of
our products could increase our future development costs or impair our future
sales.
None
of
our products or technologies have been approved by the FDA for sales in the
United States or in foreign countries. To exploit the commercial potential
of
our technologies, we are conducting and planning to conduct additional
pre-clinical studies and clinical trials. This process is expensive and can
require a significant amount of time. Failure can occur at any stage of testing,
even if the results are favorable. Failure to adequately demonstrate safety
and
efficacy in clinical trials would prevent regulatory approval and restrict
our
ability to commercialize our technologies. Any such failure may severely harm
our business. In addition, any approvals we obtain may not cover all of the
clinical indications for which approval is sought, or may contain significant
limitations in the form of narrow indications, warnings, precautions or
contraindications with respect to conditions of use, or in the form of onerous
risk management plans, restrictions on distribution, or post-approval study
requirements.
11
State
pharmaceutical marketing compliance and reporting requirements may expose us
to
regulatory and legal action by state governments or other government
authorities.
In
recent
years, several states, including California, Vermont, Maine, Minnesota, New
Mexico and West Virginia, have enacted legislation requiring pharmaceutical
companies to establish marketing compliance programs and file periodic reports
on sales, marketing, pricing and other activities. Similar legislation is being
considered in other states. Many of these requirements are new and uncertain,
and available guidance is limited. Unless we are in full compliance with these
laws, we could face enforcement action and fines and other penalties and could
receive adverse publicity, all of which could harm our business.
We
may be subject to new federal and state legislation to submit information on
our
open and completed clinical trials to public registries and
databases.
In
1997,
a public registry of open clinical trials involving drugs intended to treat
serious or life-threatening diseases or conditions was established under the
Food and Drug Administration Modernization Act, or the FDMA, in order to promote
public awareness of and access to these clinical trials. Under the FDMA,
pharmaceutical manufacturers and other trial sponsors are required to post
the
general purpose of these trials, as well as the eligibility criteria, location
and contact information of the trials. Since the establishment of this registry,
there has been significant public debate focused on broadening the types of
trials included in this or other registries, as well as providing for public
access to clinical trial results. A voluntary coalition of medical journal
editors has adopted a resolution to publish results only from those trials
that
have been registered with a no-cost, publicly accessible database, such as
www.clinicaltrials.gov. Federal legislation was introduced in the fall of 2004
to expand www.clinicaltrials.gov and to require the inclusion of study results
in this registry. The Pharmaceutical Research and Manufacturers of America
has
also issued voluntary principles for its members to make results from certain
clinical studies publicly available and has established a website for this
purpose. Other groups have adopted or are considering similar proposals for
clinical trial registration and the posting of clinical trial results. Failure
to comply with any clinical trial posting requirements could expose us to
negative publicity, fines and other penalties, all of which could materially
harm our business.
We
will face uncertainty related to pricing and reimbursement and health care
reform.
In
both
domestic and foreign markets, sales of our products will depend in part on
the
availability of reimbursement from third-party payors such as government health
administration authorities, private health insurers, health maintenance
organizations and other health care-related organizations. Reimbursement by
such
payors is presently undergoing reform and there is significant uncertainty
at
this time how this will affect sales of certain pharmaceutical
products.
Medicare,
Medicaid and other governmental healthcare programs govern drug coverage and
reimbursement levels in the United States. Federal law requires all
pharmaceutical manufacturers to rebate a percentage of their revenue arising
from Medicaid-reimbursed drug sales to individual states. Generic drug
manufacturers’ agreements with federal and state governments provide that the
manufacturer will remit to each state Medicaid agency, on a quarterly basis,
11%
of the average manufacturer price for generic products marketed and sold under
abbreviated new drug applications covered by the state’s Medicaid program. For
proprietary products, which are marketed and sold under new drug applications,
manufacturers are required to rebate the greater of (a) 15.1% of the average
manufacturer price or (b) the difference between the average manufacturer price
and the lowest manufacturer price for products sold during a specified
period.
Both
the
federal and state governments in the United States and foreign governments
continue to propose and pass new legislation, rules and regulations designed
to
contain or reduce the cost of health care. Existing regulations that affect
the
price of pharmaceutical and other medical products may also change before any
products are approved for marketing. Cost control initiatives could decrease
the
price that we receive for any product developed in the future. In addition,
third-party payors are increasingly challenging the price and cost-effectiveness
of medical products and services and litigation has been filed against a number
of pharmaceutical companies in relation to these issues. Additionally, some
uncertainty may exist as to the reimbursement status of newly approved
injectable pharmaceutical products. Our products may not be considered cost
effective or adequate third-party reimbursement may not be available to enable
us to maintain price levels sufficient to realize an adequate return on our
investment.
12
Other
companies may claim that we infringe their intellectual property or proprietary
rights, which could cause us to incur significant expenses or prevent us from
selling products.
Our
success will depend in part on our ability to operate without infringing the
patents and proprietary rights of third parties. The manufacture, use and sale
of new products have been subject to substantial patent rights litigation in
the
pharmaceutical industry. These lawsuits generally relate to the validity and
infringement of patents or proprietary rights of third parties. Infringement
litigation is prevalent with respect to generic versions of products for which
the patent covering the brand name product is expiring, particularly since
many
companies which market generic products focus their development efforts on
products with expiring patents. Other pharmaceutical companies, biotechnology
companies, universities and research institutions may have filed patent
applications or may have been granted patents that cover aspects of our products
or our licensors’ products, product candidates or other
technologies.
Future
or
existing patents issued to third parties may contain patent claims that conflict
with our products. We expect to be subject to infringement claims from time
to
time in the ordinary course of business, and third parties could assert
infringement claims against us in the future with respect to our current
products or with respect to products that we may develop or license. Litigation
or interference proceedings could force us to:
·
|
stop
or delay selling, manufacturing or using products that incorporate
or are
made using the challenged intellectual
property;
|
·
|
pay
damages; or
|
·
|
enter
into licensing or royalty agreements that may not be available on
acceptable terms, if at all.
|
Any
litigation or interference proceedings, regardless of their outcome, would
likely delay the regulatory approval process, be costly and require significant
time and attention of our key management and technical personnel.
Any
inability to protect intellectual property rights in the United States and
foreign countries could limit our ability to manufacture or sell
products.
We
will
rely on trade secrets, unpatented proprietary know-how, continuing technological
innovation and, in some cases, patent protection to preserve a competitive
position. Our patents and licensed patent rights may be challenged, invalidated,
infringed or circumvented, and the rights granted in those patents may not
provide proprietary protection or competitive advantages to us. We and our
licensors may not be able to develop patentable products. Even if patent claims
are allowed, the claims may not issue, or in the event of issuance, may not
be
sufficient to protect
the
technology owned by or licensed to us. Third party patents could reduce the
coverage of the patent’s license, or that may be licensed to or owned by us. If
patents containing competitive or conflicting claims are issued to third
parties, we may be prevented from commercializing the products covered by such
patents, or may be required to obtain or develop alternate technology. In
addition, other parties may duplicate, design around or independently develop
similar or alternative technologies.
We
may
not be able to prevent third parties from infringing or using our intellectual
property, and the parties from whom we may license intellectual property may
not
be able to prevent third parties from infringing or using the licensed
intellectual property. We generally will attempt to control and limit access
to,
and the distribution of, our product documentation and other proprietary
information. Despite efforts to protect this proprietary information, however,
unauthorized parties may obtain and use information that we may regard as
proprietary. Other parties may independently develop similar know-how or may
even obtain access to these technologies.
The
laws
of some foreign countries do not protect proprietary information to the same
extent as the laws of the United States, and many companies have encountered
significant problems and costs in protecting their proprietary information
in
these foreign countries.
The
U.S.
Patent and Trademark Office and the courts have not established a consistent
policy regarding the breadth of claims allowed in pharmaceutical patents. The
allowance of broader claims may increase the incidence and cost of patent
interference proceedings and the risk of infringement litigation. On the other
hand, the allowance of narrower claims may limit the value of our proprietary
rights.
13
We
may be required to defend lawsuits or pay damages for product liability
claims.
Product
liability is a major risk in testing and marketing biotechnology and
pharmaceutical products. We may face substantial product liability exposure
in
human clinical trials and for products that
we sell
after regulatory approval. We carry product liability insurance and we expect
to
continue such policies. Product liability claims, regardless of their merits,
could exceed policy limits, divert management’s attention, and adversely affect
our reputation and the demand for our products.
Compliance
with requirements of Section 404 of the Sarbanes-Oxley Act of 2002 will increase
our costs and require additional management resources, and we may not
successfully comply.
As
directed by Section 404 of the Sarbanes-Oxley Act of 2002, the SEC adopted
rules
requiring public companies to include a report of management on the Company’s
internal controls over financial reporting in their annual reports on Form
10-K.
In addition, the independent registered public accounting firm auditing the
Company’s financial statements must attest to and report on management’s
assessment of the effectiveness of the Company’s internal controls over
financial reporting. Although the SEC has postponed the effectiveness of these
requirements several times, if the SEC does not postpone or otherwise alter
these requirements again, then we expect that the requirement to include a
report of management on the Company’s internal controls, including the
requirement to include the attestation report of the Company’s independent
registered public accounting firm, will first apply to our annual report on
Form
10-K for our fiscal year ending December 31, 2007. If we are required to comply,
we will incur significant legal, accounting, and other expenses; and compliance
will occupy a substantial amount of time of our board of directors and
management. Uncertainty exists regarding our ability to comply with these
requirements by the SEC’s current deadlines. If we are unable to complete the
required assessment as to the adequacy of our internal control reporting or
if
we conclude that our internal controls over financial reporting are not
effective or if our independent registered public accounting firm is unable
to
provide us with an unqualified report as to the effectiveness of our internal
controls over financial reporting as of December 31, 2007 and future year-ends,
investors could lose confidence in the reliability of our financial reporting.
In addition, while we may expand our staff to assist in complying with the
additional requirements when and if they become applicable, we may encounter
substantial difficulty attracting qualified staff with requisite experience
due
to the high level of competition for experienced financial professionals.
We
May Issue Preferred Stock in the Future, and the Terms of the Preferred Stock
May Reduce the Value of Our Common Stock
We
are
authorized to issue up to 10,000,000 shares of preferred stock in one or more
series. Our board of directors may determine the terms of future preferred
stock
offerings without further action by our shareholders. If we issue preferred
stock, it could affect the rights or our common shareholders or reduce the
value
of our outstanding common stock. In particular, specific rights granted to
future holders of preferred stock may include voting rights, preferences as
to
dividends and liquidation, conversion and redemption rights, sinking fund
provisions, and restrictions on our ability to merge with or sell our assets
to
a third party.
We
May Experience Volatility in Our Stock Price, Which May Adversely Affect the
Trading Price of Our Common Stock.
The
market price for our common stock has been, and may continue to be, volatile
and
subject to price and volume fluctuations in response to market and other
factors, including the following, some of which are beyond our
control:
·
|
the
increased concentration of the ownership of our shares by a limited
number
of affiliated shareholders following the Merger may limit interest
in our
securities;
|
·
|
variations
in quarterly operating results from the expectations of securities
analysts or investors;
|
·
|
announcements
of technological innovations or new products or services by us or
our
competitors;
|
·
|
general
technological, market or economic
trends;
|
·
|
investor
perception of the industry or our
prospects;
|
·
|
investors
entering into short sale contracts;
|
·
|
regulatory
developments affecting the biopharmaceutical industry;
and
|
·
|
additions
or departures of key personnel.
|
Future
sales of substantial amounts of our common stock may adversely affect our market
price.
In
connection with the Merger, we issued a significant number of additional shares
of our common stock to a small number of shareholders. Although the shares
issued in the Merger were not immediately freely tradable, we anticipate such
shares will be tradable in market transactions one year after the closing of
the
Merger subject to the requirements of Rule 144 promulgated under the Securities
Exchange Act of 1934, as amended. Future sales of substantial amounts of our
common stock into the public market, or perceptions in the market that such
sales could occur, may adversely affect the prevailing market price of our
common stock.
14
Item
1B.
|
Unresolved
Staff Comments
|
None
Item
2.
|
Properties
|
We
lease
office and laboratory space located at 1256 Briarcliff Road, Emtech Bio Suite
500, Atlanta, Georgia under a month-to-month lease agreement with Emtech
Biotechnology Development, Inc., a related party associated with Emory
University. We also share the lease expense for office space in the Chicago
area
for one of our officers and directors, but we are not obligated under any lease
agreement for such space.
Item
3
|
Legal
Proceedings
|
We
are
not currently a party to any material legal proceedings. We may from time to
time become involved in various legal proceedings arising in the ordinary course
of business.
Item
4.
|
Submission
of Matters to Vote of Security
Holders
|
No
matters were submitted to a vote of security holders during the fourth quarter
of 2006.
PART
II
Item
5.
|
Market
for Registrant’s Common Equity and Related Shareholder Matters
|
Market
Information
Our
common stock is currently traded on the over-the-counter market under the symbol
“GOVX.OB”. The following table sets forth the high and low bid prices for our
common stock for the periods indicated. The prices represent quotations between
dealers and do not include retail mark-up, markdown, or commission, and do
not
necessarily represent actual transactions:
High
|
Low
|
||||||
2007
|
|||||||
January
1 to March 23
|
$
|
0.50
|
$
|
0.18
|
|||
2006
|
|||||||
Fourth
Quarter
|
0.68
|
0.18
|
|||||
Third
Quarter
|
0.73
|
0.44
|
|||||
Second
Quarter
|
0.85
|
0.35
|
|||||
First
Quarter
|
1.23
|
0.28
|
|||||
2005
|
|||||||
Fourth
Quarter
|
0.91
|
0.47
|
|||||
Third
Quarter
|
0.51
|
0.41
|
|||||
Second
Quarter
|
0.56
|
0.24
|
|||||
First
Quarter
|
0.33
|
0.13
|
15
Holders
On
March
23, 2007, there were approximately 1,300 holders of record of our common stock.
The number of record holders does not reflect the number of beneficial owners
of
our common stock for whom shares are held by brokerage firms and other
institutions.
Dividends
We
have
not paid any dividends since our inception and do not contemplate paying
dividends in the foreseeable future.
Securities
Authorized for Issuance Under Equity Compensation Plans
We
have
outstanding stock options under our 2006 Equity Incentive Plan (the “Plan”)
which was adopted by our board of directors and approved by our shareholders.
We
do not have any equity compensation plans that have not been approved by our
shareholders. In December, 2006, the Board of Directors of the Company amended
the Plan to make an additional 15,000,000 shares available under the Plan,
increasing the total number of shares under the Plan from 36,000,000 to
51,000,000 shares. The Company intends to submit this amendment to its
shareholders for approval at the Company’s 2007 Annual Meeting of Shareholders.
The following table sets forth information as of December 31, 2006, with respect
to our equity compensation plan.
Number
of securities
to
be issued upon
exercise
of
outstanding
options,
warrants
and rights
|
Weighted-average
exercise
price of
outstanding
options,
warrants
and rights
|
Number
of securities
remaining
available
for
future issuance
under
equity
compensation
plans
(excluding
securities
reflected
in column (a))
|
||||
(a)
|
(b)
|
(c)
|
||||
Equity
compensation plans approved by security holders
|
36,000,000
|
$0.04
|
1,568,968
|
|||
Equity
compensation plans not approved by security holders
|
-
|
-
|
15,000,000
|
Recent
Sales of Unregistered Securities
On
or
about November 7, 2006, we issued 2,841,274 shares of our common stock to
Crescent International Ltd. ("Crescent") pursuant to a "cashless" exercise
of
all remaining stock purchase warrants held by the investor. We relied on
the exemption from registration provided by Section 4(2) of the Securities
Action of 1933 and Rule 506 promulgated thereunder to issue the common stock,
inasmuch as Crescent was an accredited investor and the transaction otherwise
met the requirements of Rule 506. In consideration of the issuance of the
shares, and at the investor's election, we withheld from the warrant exercise
2,315,139 shares valued at $0.395 per share, the fair market value of the shares
on the exercise date.
Issuer
Purchases of Equity Securities
We
did
not repurchase any of our equity securities during the fourth quarter of
2006.
Performance
Graph
The
following line graph presentation compares cumulative total shareholder returns
of GeoVax’s Common Stock with the Russell 2000 Index and the RDG SmallCap
Biotechnology Index (the “Peer Index”) for the five-year period from December
31, 2001 to December 31, 2006. The graph and table assume that $100 was invested
in each of GeoVax’s common stock, the Russell 2000 Index and the Peer Index on
December 31, 2001, and that all dividends were reinvested. This data was
furnished by the Research Data Group.
16
December
31,
|
||||||
2001
|
2002
|
2003
|
2004
|
2005
|
2006
|
|
GeoVax
Labs, Inc.
|
100.00
|
20.37
|
4.63
|
18.52
|
79.63
|
20.93
|
Russell
2000
|
100.00
|
79.52
|
117.09
|
138.55
|
144.86
|
171.47
|
RDG
Small Cap Biotechnology
|
100.00
|
42.79
|
68.75
|
72.42
|
64.75
|
59.28
|
Item
6.
|
Selected
Financial Data
|
The
historical consolidated balance sheet data as of December 31, 2006, 2005, 2004,
2003 and 2002 and the related historical consolidated statement of operations
data for the years then ended are derived from our audited consolidated
financial statements included elsewhere in this Form 10-K. The historical
results presented below are not necessarily indicative of the results to be
expected for any future period. You should read the information set forth below
in conjunction with “Management’s Discussion and Analysis of Financial Condition
and Results of Operations” and our consolidated financial statements and the
related notes.
2006
|
2005
|
2004
|
2003
|
2002
|
||||||||||||
Statement
of Operations Data:
|
||||||||||||||||
Total
revenues (grant income)
|
$
|
852,905
|
$
|
670,467
|
$
|
714,852
|
$
|
992,720
|
$
|
180,237
|
||||||
Net
loss
|
(584,166
|
)
|
(1,611,086
|
)
|
(2,351,828
|
)
|
(947,804
|
)
|
(618,137
|
)
|
||||||
Basic
and diluted net loss per common share
|
(0.00
|
)
|
(0.01
|
)
|
(0.01
|
)
|
(0.00
|
)
|
(0.00
|
)
|
||||||
Balance
Sheet Data:
|
||||||||||||||||
Total
assets
|
2,396,330
|
1,685,218
|
1,870,089
|
2,316,623
|
371,026
|
|||||||||||
Redeemable
convertible preferred stock
|
-
|
1,016,555
|
938,475
|
866,391
|
799,844
|
|||||||||||
Total
stockholders’ equity (deficit)
|
2,203,216
|
(500,583
|
)
|
(389,497
|
)
|
872,406
|
(639,393
|
)
|
17
Item
7.
|
Management’s
Discussion and Analysis of Financial Condition and Results of
Operations
|
The
following discussion and analysis of our financial condition and results of
operations should be read together with the discussion under “Selected Financial
Data” and our consolidated financial statements included in this Annual Report.
This discussion contains forward-looking statements, based on current
expectations and related to future events and our future financial performance,
that involve risks and uncertainties. Our actual results may differ materially
from those anticipated in these forward-looking statements as a result of many
important factors, including those set forth under “Risk Factors” and elsewhere
in this Annual Report.
Overview
GeoVax
is
a clinical stage biotechnology company focused on developing human vaccines
for
diseases caused by Human Immunodeficiency Virus and other infectious agents.
We
have exclusively licensed from Emory University certain AIDS vaccine technology
which was developed in collaboration with the National Institutes of Health
and
the Centers for Disease Control and Prevention.
Thus
far
in our vaccine development activities, our vaccine candidates have undergone
preclinical efficacy testing in non-human primates and Phase I clinical testing
in humans. The human trial, which was conducted by the HIV Vaccine Trials
Network (HVTN), a division of NIAID-NIH, began in January 2003 and was
satisfactorily concluded in June 2004.
The
start
of a series of four additional human trials (conducted by HVTN) evaluating
our
AIDS vaccines at four locations in the United States began in April 2006.
Another human trial began in September 2006 with two more scheduled for
mid-2007. The cost of the human clinical trials to date have been borne by
HVTN,
with GeoVax incurring costs associated with manufacturing the clinical vaccine
supplies and other study support. Our vaccine manufacturing costs, as well
as
the costs of our preclinical testing have been partially funded by grants from
the National Institutes of Health issued to Emory University and subcontracted
to us pursuant to collaborative arrangements with Emory. It is unlikely that
additional government grant funding will be available to us as we progress
to
the later stages of our vaccine development activities.
We
anticipate incurring additional losses for several years as we expand our drug
development and clinical programs. We also expect that losses will fluctuate
from quarter to quarter and that such fluctuations may be substantial.
Conducting clinical trials for our drug candidates in development is a lengthy,
time-consuming and expensive process. We do not expect to generate product
sales
from our drug discovery and development efforts for several years, if at all.
If
we are unable to successfully develop and market pharmaceutical products over
the next several years, our business, financial condition and results of
operations would be adversely impacted.
Critical
Accounting Policies and Estimates
Management’s
discussion and analysis of our financial condition and results of operations
are
based on our consolidated financial statements, which have been prepared in
accordance with accounting principles generally accepted in the United States.
The preparation of these financial statements requires management to make
estimates and judgments that affect the reported amounts of assets, liabilities,
revenues and expenses, and related disclosure of contingent assets and
liabilities. On an ongoing basis, management evaluates its estimates and adjusts
the estimates as necessary. We base our estimates on historical experience
and
on various other assumptions that are believed to be reasonable under the
circumstances, the results of which form the basis for making judgments about
the carrying values of assets and liabilities that are not readily apparent
from
other sources. Actual results may differ materially from these estimates under
different assumptions or conditions.
Our
significant accounting policies are summarized in Note 2 to our consolidated
financial statements. We believe the following critical accounting policies
affect our more significant judgments and estimates used in the preparation
of
our consolidated financial statements:
Other
Assets
Other
assets consist principally of license agreements for the use of technology
obtained through the issuance of the Company’s common stock. These license
agreements are amortized on a straight line basis over ten years.
18
Impairment
of Long-Lived Assets
Long-lived
assets are reviewed for impairment whenever events or changes in circumstances
indicate that the carrying amount of an asset may not be recoverable.
Recoverability of assets to be held and used is measured by a comparison of
the
carrying amount of the assets to the future net cash flows expected to be
generated by such assets. If such assets are considered to be impaired, the
impairment to be recognized
is measured by the amount by which the carrying amount of the assets exceeds
the
discounted expected future net cash flows from the assets.
Revenue
Recognition
The
Company’s revenue consists of subcontracted government grant revenue received
pursuant to collaborative arrangements with Emory University. Revenue from
these
collaborative research arrangements is deferred and recorded as income as the
related costs are incurred.
Stock-Based
Compensation
Effective
January 1, 2006, the Company adopted Statement of Financial Accounting Standards
(“SFAS”) No.123 (revised 2004), Share-Based
Payments (“SFAS
No. 123R”), which requires the measurement and recognition of compensation
expense for all share-based payments made to employees and directors based
on
estimated fair values on the grant date. SFAS No. 123R replaces SFAS No. 123,
Accounting
for Stock-Based Compensation,
and
supersedes Accounting Principles Board (“APB”) Opinion No. 25, Accounting
for Stock Issued to Employees
(“APB
No. 25”).
The
Company has adopted SFAS No. 123R using the prospective application method
which
requires the Company to apply the provisions of SFAS No. 123R prospectively
to
new awards and to awards modified, repurchased or cancelled after December
31,
2005. Awards granted after December 31, 2005 are valued at fair value in
accordance with the provisions of SFAS No. 123R and recognized on a straight
line basis over the service periods of each award.
Prior
to
January 1, 2006, the Company accounted for stock-based compensation using the
intrinsic value method in accordance with APB No. 25 and applied the disclosure
provisions of SFAS No. 123, as amended by SFAS No. 148, Accounting
for Stock-Based Compensation and Disclosure.
Under
those provisions, the Company provided pro forma disclosures as if the fair
value measurement provisions of SFAS No. 123 had been used in determining
compensation expense. The Company used a minimum value option-pricing model
to
determine the pro forma impact on the Company’s net income. This model utilizes
certain information, such as the interest rate on a risk-free security with
a
term generally equivalent to the expected life of the option being valued and
requires certain other assumptions, such as the expected amount of time an
option will be outstanding until it is exercised or expires, to calculate the
fair value of stock options granted.
Liquidity
and Capital Resources
At
December 31, 2006, we had cash and cash equivalents of $2,088,149 and total
assets of $2,396,330, as compared to $1,272,707 and $1,685,218, respectively,
at
December 31, 2005. Working capital totaled $1,933,165 at December 31, 2006,
compared to $266,292 at December 31, 2005. We believe that we have adequate
working capital to support our currently planned level of operations into the
third quarter of 2007 or longer.
Sources
and Uses of Cash.
Due to
our significant research and development expenditures, we have not been
profitable and have generated operating losses since our inception in 2001.
Our
primary source of cash during the three years ended December 31, 2006 was from
sales of our equity securities and from subcontracted government grant funding
received from collaborative arrangements with Emory University.
Cash
Flows from Operating Activities.
Net
cash used in operating activities was $1,327,941, $1,807,069 and $1,514,143
for
the years ended December 31, 2006, 2005 and 2004, respectively. The fluctuations
between years are primarily due to fluctuations in our net losses which, in
turn, result from fluctuations in expenditures from our research activities,
offset by net changes in our assets and liabilities.
Cash
Flows from Investing Activities.
Our
investing activities have consisted predominantly of capital expenditures.
Capital expenditures for the years ended December 31, 2006, 2005 and 2004,
were
$69,466, $48,485 and $7,070, respectively.
Cash
Flows from Financing Activities.
Net
cash provided by financing activities was $2,212,849, for the year ended
December 31, 2006. During 2006, we received $1,712,849 in net proceeds (reduced
by $287,151 of costs directly associated with the Merger) from the sale of
our
common stock in connection with the merger of GeoVax Labs, Inc. and GeoVax,
Inc.
Additionally, during 2006, 2005 and 2004 we received $500,000, $1,500,000 and
$989,919, respectively, from the payment of a stock subscription receivable
related to the sale of our common stock in 2004.
19
Our
capital requirements, particularly as they relate to product research and
development, have been and will continue to be significant. We intend to seek
FDA approval of our products, which may take several years. We will not generate
revenues from our products for at least several years, if at all. We will be
dependent on obtaining financing from third parties in order to maintain our
operations, including our clinical program. Although we are actively negotiating
terms for a financing arrangement, we currently have no commitments from any
third parties to provide us with capital. We cannot assure that additional
funding will be available to us on favorable terms, or at all. If we fail to
obtain additional funding when needed, we would be forced to scale back, or
terminate, our operations, or to seek to merge with or to be acquired by another
company.
Contractual
Obligations
As
of
December 31, 2006, we had no commitments for capital expenditures or other
purchase obligations, no committed lines of credit or other committed funding
or
long-term debt, and no lease obligations (operating or capital). We have
employment agreements with our President & Chief Executive Officer, our
Senior Vice President and our Chief Financial Officer which may be terminated
with 30 days advance notice. We have no other contractual obligations, with
the
exception of commitments which are contingent upon the occurrence of future
events.
Net
Operating Loss Carryforward
At
December 31, 2006, we had consolidated net operating loss carryforwards for
income tax purposes of $65.6 million, which will expire in 2010 through 2026
if
not utilized. Approximately $59.7 million of our net operating loss
carryforwards relate to the operations of the Company (Dauphin Technology,
Inc.)
prior to the Merger. We also have research and development tax credits of
$202,000 available to reduce income taxes, if any, which will expire in 2022
through 2025 if not utilized. The amount of net operating loss carryforwards
and
research tax credits available to reduce income taxes in any particular year
may
be limited in certain circumstances. Based on an assessment of all available
evidence including, but not limited to, our limited operating history in our
core business and lack of profitability, uncertainties of the commercial
viability of our technology, the impact of government regulation and healthcare
reform initiatives, and other risks normally associated with biotechnology
companies, we have concluded that it is more likely than not that these net
operating loss carryforwards and credits will not be realized and, as a result,
a 100% deferred tax valuation allowance has been recorded against these assets.
Results
of Operations
Net
Loss
GeoVax
recorded net losses of $584,166, $1,611,086 and $2,351,828 for the years ended
December 31, 2006, 2005 and 2004, respectively. The fluctuations in our
operating losses are primarily attributable to the timing of activities and
related costs associated with our vaccine research and development activities.
The $1,026,920 decrease in our net loss from 2005 to 2006 is attributable to
a
reduction in our vaccine research and development activities as we focused
our
attention on completing the Merger and reduced our product development
activities in order to conserve cash resources, coupled with an increase of
$182,438 in our revenue recorded from government grants.
Grant
Revenue
Grant
revenue relates to projects covered by grants from the National Institutes
of
Health issued to Emory University and subcontracted to us pursuant to
collaborative arrangements with Emory. We recorded grant revenues of $852,905
in
2006, $670,467 in 2005 and $714,852 in 2004. We expect that grant money from
the
federal government will decrease in the future because grant funding from
federal agencies is primarily allocated to basic research projects. Therefore,
the availability of federal grant money to us is expected to decline as our
research moves toward product development and human testing of formulated AIDS
vaccines. Although we do not expect to receive any direct grant funding or
grant
funding subcontracted through Emory during 2007, our planned clinical trials
will be conducted and funded by HVTN.
Research
and Development
Our
research and development expenses were $665,863 in 2006, $1,640,814 in 2005
and
$2,566,902 in 2004. Research and development expenses vary considerably on
a
period-to-period basis, depending on our need for vaccine manufacturing and
testing of manufactured vaccine by third parties. Research and development
expense declined from 2005 to 2006 primarily as we focused our attention on
completing the Merger and reduced our product development activities in order
to
conserve cash resources. We expect our research and development costs to
increase in 2007 as we manufacture more vaccine supplies for clinical trials
later in 2007 and in 2008. We expect that our research and development costs
will continue to increase as we progress through the human clinical trial
process leading up to possible product approval by the FDA.
20
General
and Administrative Expense
Our
general and administrative expenses were $843,335 in 2006, $655,199 in 2005
and
$524,780 in 2004. General and administrative costs include officers’ salaries,
legal and accounting costs, patent costs, and amortization and accretion expense
associated with intangible assets and redeemable preferred stock outstanding.
General and administrative costs have generally increased during the three
year
period ending December 31, 2006 primarily as a result of higher patent costs
and
administrative personnel costs. The increase from 2005 to 2006 is also partially
attributable to higher legal costs associated with the merger of GeoVax Labs,
Inc and GeoVax, Inc. in September 2006, and with the higher administrative
costs
associated with being a publicly traded entity after the merger. We expect
our
general and administrative expenses in 2007 to be higher than those incurred
in
2006, resulting from our being a publicly traded entity. These higher costs
include, among other things, the costs of an expanded financial function
(including the engagement of our Chief Financial Officer), a newly instituted
investor relations program, costs associated with an expanded Board of Directors
and costs associated with our efforts to comply with the Sarbanes-Oxley Act
of
2002.
Other
Income & Expense
Interest
income was $72,127 in 2006, as compared to $16,073 in 2005 and $25,002 in 2004.
The variances between years are primarily attributable to the cash available
for
investment, which totaled $2,088,149 at December 31, 2006, $1,272,707 at
December 31, 2005 and $2,159,555 at December 31, 2004.
During
2005 we recorded $1,613 of interest expense related to short-term borrowings
which were repaid during the year. We had no outstanding debt at December 31,
2006 or 2005.
Impact
of Inflation
For
the
three year period ending December 31, 2006, we do not believe that inflation
and
changing prices had a material impact on our operations or on our financial
results.
Off-Balance
Sheet Arrangements
We
have
not entered into off-balance sheet financing arrangements, other than operating
leases.
Item
7A.
|
Quantitative
and Qualitative Disclosures about Market
Risk
|
Our
exposure to market risk is limited primarily to interest income sensitivity,
which is affected by changes in the general level of United States interest
rates, particularly because a significant portion of our investments are in
short-term debt securities issued by the U.S. government and institutional
money
market funds. The primary objective of our investment activities is to preserve
principal while at the same time maximizing the income received without
significantly increasing risk. Due to the nature of our short-term investments,
we believe that we are not subject to any material market risk exposure. We
do
not have any derivative financial instruments or foreign currency instruments.
Item
8.
|
Financial
Statements and Supplementary
Data
|
Our
consolidated financial statements and supplemental schedule and notes thereto
as
of December 31, 2006 and 2005, and for each of the three years ended December
31, 2006, 2005 and 2004, together with the independent registered public
accounting firms’ reports thereon, are set forth on pages F-1 to F-15 of this
Annual Report on Form 10-K.
Item
9.
|
Changes
in and Disagreements with Accountants on Accounting or Financial
Disclosure
|
There
were no disagreements with our accountants on matters of accounting or financial
disclosure, or other reportable events requiring disclosure under this Item
9.
21
Item
9A.
|
Controls
and Procedures
|
Disclosure
Controls and Procedures
We
maintain disclosure controls and procedures designed to ensure that financial
information required to be disclosed in our reports filed under the Securities
Exchange Act of 1934, as amended (the Exchange Act), is recorded, processed,
summarized, and reported within the required time periods, and that such
information is accumulated and communicated to our management, including our
Chief Executive Officer and Chief Financial Officer, as appropriate, to allow
for timely decisions regarding disclosure.
During
the quarter ended December 31, 2006, the following changes in our internal
control over financial reporting occurred:
·
|
Effective
with our merger with GeoVax, Inc on September 28, 2006, we adopted
GeoVax,
Inc.’s accounting policies, methods and procedures, which represented
a
significant improvement over our then existing accounting practices.
These
policies, methods and procedures were effectively implemented on
October
1, 2006.
|
·
|
Our
Board of Directors formed an Audit Committee at a meeting held in
December
2006, and appointed two members. Prior to the formation of our Audit
Committee, and subsequent to our merger with GeoVax, Inc., an independent
member of our Board provided oversight to the review process of our
third
quarter 2006 Form 10-Q, filed with the SEC in November 2006, which
included direct contact with our external
auditors.
|
An
evaluation was performed by our Chief Executive Officer and Chief Financial
Officer of the effectiveness of the design and operation of our disclosure
controls and procedures as of December 31, 2006. Based on that evaluation,
our
Chief Executive Officer and Chief Financial Officer have concluded that our
disclosure controls and procedures were effective as of December 31, 2006 to
provide reasonable assurance that information required to be disclosed by us
in
reports that we file or submit under the Exchange Act is recorded, processed,
summarized and reported within the time periods specified in the SEC rules
and
forms.
Item
9B.
|
Other
Information
|
None.
PART
III
Item
10.
|
Directors,
Executive Officers and Corporate
Governance
|
Certain
information required by this Item is included in our definitive proxy statement
for our 2007 annual meeting of shareholders to be filed with the SEC under
the
captions “Directors and Executive Officers” and “Corporate Governance” and is
incorporated herein by this reference.
Code
of Ethics
We
have
adopted a Code of Business Conduct and Ethics in compliance with the applicable
rules of the SEC that applies to our principal executive officer, our principal
financial officer and our principal accounting officer or controller, or persons
performing similar functions. A copy of this policy is available free of charge
upon written request to the attention of our Corporate Secretary by regular
mail, email to mreynolds@geovax.com, or facsimile at 404-712-9357. We intend
to
disclose any amendment to, or a waiver from, a provision of our code of ethics
that applies to our principal executive officer, principal financial officer,
principal accounting officer or controller, or persons performing similar
functions and that relates to any element of the code of ethics enumerated
in
applicable rules of the SEC. Such disclosures will be made on our website at
www.geovax.com.
22
Item
11.
|
Executive
Compensation
|
The
information required by this Item is included in our definitive proxy statement
for our 2007 annual meeting of shareholders to be filed with the SEC under
the
captions “Corporate Governance” and “Compensation of Directors and Executive
Officers” and is incorporated herein by this reference.
Item
12.
|
Security
Ownership of Certain Beneficial Owners and Management and Related
Shareholder Matters
|
The
information required by this Item regarding security ownership is included
in
our definitive proxy statement for our 2007 annual meeting of shareholders
to be
filed with the SEC under the caption “Security Ownership of Principal
Shareholders, Directors and Officers” and is incorporated herein by this
reference.
Item
13.
|
Certain
Relationships and Related Party Transactions, and Director
Independence
|
The
information required by this Item is included in our definitive proxy statement
for our 2007 annual meeting of shareholders to be filed with the SEC under
the
captions “Corporate Governance” and “Certain Relationships and Related
Transactions” and is incorporated herein by this reference.
Item
14.
|
Principal
Accounting Fees and
Services
|
The
information required by this Item with respect to principal accounting fees
and
services is included in our definitive proxy statement for our 2007 annual
meeting of shareholders to be filed with the SEC under the caption “Independent
Public Accountants” and is incorporated herein by this reference.
PART
IV
Item
15.
|
Exhibits
and Financial Statement
Schedules
|
(1)
|
Financial
Statements
|
Page
|
|
Reports
of Independent Registered Public Accounting Firms
|
|
Porter
Keadle Moore, LLP
|
F-2
|
Tripp,
Chafin & Causey, LLC
|
F-3
|
Consolidated
Balance Sheets as of December 31, 2006 and 2005
|
F-4
|
Consolidated
Statements of Operations for the years ended December 31, 2006, 2005
and
2004 and for the Period from Inception (June 27, 2001) to December
31,
2006
|
F-5
|
Consolidated
Statements of Stockholders’ Equity (Deficiency) for the Period from
Inception (June 27, 2001) to December 31, 2006
|
F-6
|
Consolidated
Statements of Cash Flows for the years ended December 31, 2006, 2005
and
2004 and for the Period from Inception (June 27, 2001) to December
31,
2006
|
F-7
|
Notes
to Consolidated Financial Statements
|
F-8
|
23
(2)
|
Financial
Statement Schedules
|
The
following financial statement schedule is set forth on page F-15 of this Annual
Report on Form 10-K:
Schedule
II—Valuation and Qualifying Accounts for each of the three years in the period
ended December 31, 2006.
All
other
financial statement schedules have been omitted because they are not applicable
or not required or because the information is included elsewhere in the
Consolidated Financial Statements or the Notes thereto.
(3)
|
Exhibits
|
See
Item
15(b) below. Each management contract or compensatory plan or arrangement
required to be filed has been identified.
(b)
|
Exhibits
|
Exhibit
Number
|
Description
|
2.1
|
Agreement
and Plan of Merger dated January 20, 2006 by and among GeoVax, Inc.,
GeoVax Acquisition Corp. and Dauphin Technology, Inc.
(1)
|
2.2
|
First
Amendment to Agreement and Plan of Merger
(2)
|
2.3
|
Second
Amendment to Agreement and Plan of Merger
(3)
|
3.1
|
Articles
of Incorporation (3)
|
3.2
|
Articles
of Merger, dated September 16, 1991
(3)
|
3.3
|
Bylaws,
as amended December 7, 2006
|
10.1*
|
Employment
Agreement with Donald Hildebrand
(3)
|
10.2*
|
Employment
Agreement with Andrew Kandalepas
|
10.3*
|
Employment
Agreement with Mark Reynolds
|
10.4*
|
GeoVax
Labs, Inc. 2006 Equity Incentive Plan
(4)
|
10.5
|
License
Agreement (as amended and restated) between GeoVax, Inc. and Emory
University, dated August 23, 2002
(3)
|
10.6
|
Technology
Sale and Patent License Agreement between GeoVax, Inc. and MFD, Inc.,
dated December 26, 2004 (3)
|
10.7
|
Equipment
and Ground Sublease between GeoVax, Inc. and EmTech Biotechnology
Development, Inc., dated December 1, 2001, together with amendment
dated
August 18, 2003 (3)
|
10.8
|
Equipment
and Ground Sublease Amendment dated November 22,
2006
|
14.1
|
Code
of Ethics
|
21.1
|
Subsidiaries
of the Registrant
|
23.1
|
Consent
of Tripp, Chafin and Causey LLP
|
31.1
|
Certification
pursuant to Rule 13a-14(a) or 15d-14(a) of the Securities Exchange
Act of
1934
|
31.2
|
Certification
pursuant to Rule 13a-14(a) or 15d-14(a) of the Securities Exchange
Act of
1934
|
32.1
|
Certification
pursuant to 18 U.S.C. Section 1350, as adopted by Section 906 of
the
Sarbanes-Oxley Act of 2002.
|
32.2
|
Certification
pursuant to 18 U.S.C. Section 1350, as adopted by Section 906 of
the
Sarbanes-Oxley Act of 2002.
|
*
|
Indicates
a management contract or compensatory plan or
arrangement
|
(1)
|
Incorporated
by reference from the registrant’s Current Report on Form 8-K filed with
the Securities and Exchange Commission on January 24,
2006.
|
24
(2)
|
Incorporated
by reference from the registrant’s Current Report on Form 8-K filed with
the Securities and Exchange Commission on July 13,
2006.
|
(3)
|
Incorporated
by reference from the registrant’s Current Report on Form 8-K filed with
the Securities and Exchange Commission on October 4,
2006.
|
(4)
|
Incorporated
by reference from the registrant’s definitive Information Statement
(Schedule 14C) filed with the Securities and Exchange Commission
on August
18, 2006.
|
25
SIGNATURES
Pursuant
to the requirements of Section 13 or 15(d) of the Securities Exchange Act of
1934, the registrant has duly caused this report to be signed on its behalf
by
the undersigned, thereunto duly authorized.
GEOVAX LABS, INC. | |
BY: /s/ Donald Hildebrand | |
Donald Hildebrand | |
President and Chief Executive Officer | |
(Principal Executive Officer) | |
Date: March 28, 2007 |
Pursuant
to the requirements of the Securities Exchange Act of 1934, this report has
been
duly signed below by the following persons on behalf of the Registrant and
in
the capacities and on the dates indicated.
Signature
/ Name
|
Title
|
Date
|
/s/
Donald
Hildebrand
|
Director
|
March
28, 2007
|
Donald
Hildebrand
|
President
& Chief Executive Officer
|
|
(Principal
Executive Officer)
|
||
/s/
Andrew J. Kandalepas
|
Director
|
March
28, 2007
|
Andrew
J. Kandalepas
|
||
/s/
Dean
Kollintzas
|
Director
|
March
28, 2007
|
Dean
Kollintzas
|
||
/s/
Robert
McNally
|
Director
|
March
28, 2007
|
Robert
McNally
|
||
/s/
Mark
Reynolds
|
Chief
Financial Officer
|
March
28, 2007
|
Mark
Reynolds
|
(Principal
Financial and Accounting Officer)
|
|
/s/
John N. Spencer,
Jr.
|
Director
|
March
28, 2007
|
John
N. Spencer, Jr.
|
26
EXHIBIT
INDEX
Exhibit
Number
|
Description
|
3.3
|
Bylaws,
as amended December 7, 2006
|
10.2*
|
Employment
Agreement with Andrew Kandalepas
|
10.3*
|
Employment
Agreement with Mark Reynolds
|
10.8
|
Equipment
and Ground Sublease Amendment dated November 22,
2006
|
14.1
|
Code
of Ethics
|
21.1
|
Subsidiaries
of the Registrant
|
23.1
|
Consent
of Tripp, Chafin and Causey LLP
|
31.1
|
Certification
pursuant to Rule 13a-14(a) or 15d-14(a) of the Securities Exchange
Act of
1934
|
31.2
|
Certification
pursuant to Rule 13a-14(a) or 15d-14(a) of the Securities Exchange
Act of
1934
|
32.1
|
Certification
pursuant to 18 U.S.C. Section 1350, as adopted by Section 906 of
the
Sarbanes-Oxley Act of 2002.
|
32.2
|
Certification
pursuant to 18 U.S.C. Section 1350, as adopted by Section 906 of
the
Sarbanes-Oxley Act of 2002.
|
·
|
Indicates
a management contract or compensatory plan or
arrangement
|
27
GEOVAX
LABS, INC.
(A
DEVELOPMENT-STAGE ENTERPRISE)
INDEX
TO 2006 CONSOLIDATED FINANCIAL STATEMENTS
Reports
of Independent Registered Public Accounting Firms
|
|
Porter
Keadle Moore, LLP
|
F-2
|
Tripp,
Chafin & Causey, LLC
|
F-3
|
Consolidated
Balance Sheets as of December 31, 2006 and 2005
|
F-4
|
Consolidated
Statements of Operations for the years ended December 31, 2006, 2005
and
2004 and for the Period from Inception (June 27, 2001) to December
31,
2006
|
F-5
|
Consolidated
Statements of Stockholders’ Equity (Deficiency) for the Period from
Inception (June 27, 2001) to December 31, 2006
|
F-6
|
Consolidated
Statements of Cash Flows for the years ended December 31, 2006, 2005
and
2004 nd for the Period from Inception (June 27, 2001) to December
31,
2006
|
F-7
|
Notes
to Consolidated Financial Statements
|
F-8
|
F-1
Porter
Keadle Moore, LLP
Report
of Independent Registered Public Accounting Firm
To
the
Board of Directors and Stockholders of
GeoVax
Labs, Inc.
Atlanta,
Georgia
We
have
audited the accompanying consolidated balance sheet of GeoVax Labs, Inc. (a
development stage company) (the “Company”) as of December 31, 2006, and the
related consolidated statements of operations, stockholders’ equity, and cash
flows for the year ended December 31, 2006, and for the period of time
considered part of the development stage from January 1, 2006 to December 31,
2006, except we did not audit the Company’s financial statements for the period
from June 27, 2001 to December 31, 2005 which were audited by other auditors,
whose latest report dated February 8, 2006 on those financial statements
included an explanatory paragraph that expressed substantial doubt about the
Company’s ability to continue as a going concern. These financial statements are
the responsibility of the Company’s management. Our responsibility is to express
an opinion on these financial statements based on our audit.
We
conducted our audit in accordance with standards of the Public Company
Accounting Oversight Board (United States). Those standards require that we
plan
and perform the audit to obtain reasonable assurance about whether the financial
statements are free of material misstatement. An audit includes examining,
on a
test basis, evidence supporting the amounts and disclosures in the financial
statements. An audit also includes assessing the accounting principles used
and
significant estimates made by management, as well as evaluating the overall
financial statement presentation. We believe that our audit provides a
reasonable basis for our opinion.
In
our
opinion, the 2006 consolidated financial statements referred to above present
fairly, in all material respects, the financial position of GeoVax Labs, Inc.
as
of December 31, 2006 and the results of their operations and their cash flows
for the year ended December 31, 2006, in conformity with accounting principles
generally accepted in the United States of America.
The
accompanying consolidated financial statements have been prepared assuming
that
the Company will continue as a going concern. As discussed in Note 1 to the
consolidated financial statements, the Company has suffered negative cash flows
from operations since inception. This raises substantial doubt about the
Company's ability to continue as a going concern. Management's plans in regard
to these matters are also described in Note 1. The financial statements do
not
include any adjustments that might result from the outcome of this
uncertainty.
Our
audit
of the consolidated financial statements also included the financial statement
schedule of the Company, listed in Item 15(a) of this Form 10-K. This schedule
is the responsibility of the Company’s management. Our responsibility is to
express an opinion based on our audit of the consolidated financial statements.
In our opinion, the financial statement schedule, when considered in relation
to
the basic consolidated financial statements taken as a whole, presents fairly
in
all material respects the information set forth therein.
/s/ Porter Keadle Moore, LLP |
Atlanta,
Georgia
February
20, 2007
Certified
Public Accountants
Suite
1800 Ÿ
235
Peachtree Street NE Ÿ
Atlanta, Georgia 30303 Ÿ
Phone
404-588-4200 Ÿ
Fax
404-588-4222 Ÿ
www.pkm.com
F-2
TRIPP,
CHAFIN & CAUSEY, LLC
Certified
Public Accountants
|
1225
Johnson Ferry Road * Suite 200 Regency Park * Marietta, Georgia
30068
phone
770.565.2422 * fax 770.565.2462
INDEPENDENT
AUDITORS' REPORT
Board
of
Directors
Geovax,
Inc.
Atlanta,
Georgia
We
have
audited the accompanying balance sheet of Geovax, Inc. (a Georgia corporation
in
the development stage) as of December 31, 2005, and the related statements
of
operations, stockholders' deficiency and cash flows for the two years then
ended
and for the period from inception (June 27, 2001) to December 31, 2005. These
financial statements are the responsibility of the Company's management.
Our
responsibility is to express an opinion on these financial statements based
on
our audit.
We
conducted our audit in accordance with the auditing standards generally accepted
in the United States of America. Those standards require that we plan and
perform the audits to obtain reasonable assurance about whether the financial
statements are free of material misstatement. An audit includes examining,
on a
test basis, evidence supporting the amounts and disclosures in the financial
statements. An audit also includes assessing the accounting principles used
and
significant estimates made by management, as well as evaluating the overall
financial statement presentation. We believe that our audit provide a reasonable
basis for our opinion.
The
accompanying financial statements have been prepared assuming that the Company
will continue as a going concern. As discussed in Note 1
to
the
financial statements, the Company's recurring losses and negative cash flows
from operations raise substantial doubt about the Company's ability to continue
as a going concern. Management's plans concerning these matters are also
described in Note 1. The financial statements do not include any adjustments
relating to the recoverability and classification of recorded asset amounts
or
the amounts and classification of liabilities that might be necessary should
the
Company be unable to continue as a going concern.
In
our
opinion, the financial statements referred to above present fairly, in all
material respects, the financial position of Geovax, Inc. as of December
31,
2005, and the results of its operations and its cash flows for the two years
then ended and for the period from inception (June 27, 2001) to December
31,
2005, in conformity with accounting principles generally accepted in the
United
States of America.
Marietta,
Georgia
|
/s/
Tripp, Chafin & Causey, LLC
|
February
8, 2006
F-3
GEOVAX
LABS, INC.
(A
DEVELOPMENT-STAGE ENTERPRISE)
CONSOLIDATED
BALANCE SHEETS
December
31,
|
|||||||
2006
|
2005
|
||||||
ASSETS
|
|||||||
Current
assets:
|
|||||||
Cash
and cash equivalents
|
$
|
2,088,149
|
$
|
1,272,707
|
|||
Prepaid
expenses and other
|
38,130
|
162,831
|
|||||
Total
current assets
|
2,126,279
|
1,435,538
|
|||||
Property
and equipment, net of accumulated depreciation of $47,092 and
$22,882 at December 31, 2006 and 2005, respectively
|
104,719
|
59,463
|
|||||
Other
assets:
|
|||||||
Licenses,
net of accumulated amortization of $84,504 and $59,619 at December
31, 2006 and 2005, respectively
|
164,352
|
189,237
|
|||||
Deposits
|
980
|
980
|
|||||
Total
other assets
|
165,332
|
190,217
|
|||||
Total
assets
|
$
|
2,396,330
|
$
|
1,685,218
|
|||
LIABILITIES
AND STOCKHOLDERS' EQUITY (DEFICIENCY)
|
|||||||
Current
liabilities:
|
|||||||
Accounts
payable and accrued expenses
|
$
|
83,983
|
$
|
54,641
|
|||
Accrued
salaries
|
109,131
|
124,308
|
|||||
Amounts
payable to related party
|
-
|
137,392
|
|||||
Unearned
grant revenue
|
-
|
852,905
|
|||||
Total
current liabilities
|
193,114
|
1,169,246
|
|||||
Commitments
|
|||||||
Mandatory
redeemable convertible preferred stock; no par value, 20,000,000
shares authorized at December 31, 2005; Series A, 5,987,520 shares
issued and outstanding at December 31, 2005 (Aggregate liquidation
preference $1,499,994)
|
-
|
1,016,555
|
|||||
Stockholders'
equity (deficiency):
|
|||||||
Preferred
stock, $.01 par value, 10,000,000 shares authorized; no
shares issued at December 31, 2006 and 2005,
respectively
|
-
|
-
|
|||||
Common
stock, $.001 par value, 850,000,000 shares authorized 711,167,943
and 312,789,565 shares outstanding at December
31, 2006 and 2005, respectively
|
711,168
|
312,790
|
|||||
Additional
paid-in capital
|
7,775,661
|
5,386,074
|
|||||
Stock
subscription receivable for common stock
|
-
|
(500,000
|
)
|
||||
Deficit
accumulated during the development stage
|
(6,283,613
|
)
|
(5,699,447
|
)
|
|||
Total
stockholders' equity (deficiency)
|
2,203,216
|
(500,583
|
)
|
||||
Total
liabilities and stockholders' equity (deficiency)
|
$
|
2,396,330
|
$
|
1,685,218
|
See
accompanying report of independent registered public accounting firm and notes
to financial statements.
F-4
GEOVAX
LABS. INC.
(A
DEVELOPMENT-STAGE ENTERPRISE)
CONSOLIDATED
STATEMENTS OF OPERATIONS
Years
Ended December 31,
|
From
Inception
(June
27, 2001) to December 31, |
||||||||||||
2006
|
2005
|
2004
|
2006
|
||||||||||
Revenue:
|
|||||||||||||
Grant
revenue
|
$
|
852,905
|
$
|
670,467
|
$
|
714,852
|
$
|
3,411,181
|
|||||
852,905
|
670,467
|
714,852
|
3,411,181
|
||||||||||
Operating
expenses:
|
|||||||||||||
Research
and development
|
665,863
|
1,640,814
|
2,566,902
|
6,993,049
|
|||||||||
General
and administrative
|
843,335
|
655,199
|
524,780
|
2,843,875
|
|||||||||
1,509,198
|
2,296,013
|
3,091,682
|
9,836,924
|
||||||||||
Loss
from operations
|
(656,293
|
)
|
(1,625,546
|
)
|
(2,376,830
|
)
|
(6,425,743
|
)
|
|||||
Other
income (expense)
|
|||||||||||||
Interest
income
|
72,127
|
16,073
|
25,002
|
147,799
|
|||||||||
Interest
expense
|
-
|
(1,613
|
)
|
-
|
(5,669
|
)
|
|||||||
72,127
|
14,460
|
25,002
|
142,130
|
||||||||||
Net
loss
|
$
|
(584,166
|
)
|
$
|
(1,611,086
|
)
|
$
|
(2,351,828
|
)
|
$
|
(6,283,613
|
)
|
|
Basic
and diluted:
|
|||||||||||||
Loss
per common share
|
$
|
(0.00
|
)
|
$
|
(0.01
|
)
|
$
|
(0.01
|
)
|
$
|
(0.02
|
)
|
|
Weighted
average shares
|
414,919,141
|
312,789,565
|
290,908,324
|
292,306,327
|
See
accompanying report of independent registered public accounting firm and notes
to financial statements.
F-5
GEOVAX
LABS, INC.
(A
DEVELOPMENT-STAGE ENTERPRISE)
CONSOLIDATED
STATEMENTS OF STOCKHOLDERS’ EQUITY (DEFICIENCY)
Common
Stock
|
Additional
Paid In
|
Stock
Subscription
|
Deficit
Accumulated during the Development
|
Total
Stockholders’Equity
|
|||||||||||||||
Shares
|
Amount
|
Capital
|
Receivable
|
Stage
|
(Deficiency)
|
||||||||||||||
Capital
contribution at inception (June 27, 2001)
|
-
|
$
|
-
|
$
|
10
|
$
|
-
|
$
|
-
|
$
|
10
|
||||||||
Net
loss for the year ended December 31, 2001
|
-
|
-
|
-
|
-
|
(170,592
|
)
|
(170,592
|
)
|
|||||||||||
Balance
at December 31, 2001
|
-
|
-
|
10
|
-
|
(170,592
|
)
|
(170,582
|
)
|
|||||||||||
Sale
of common stock for cash
|
139,497,711
|
139,498
|
(139,028
|
)
|
-
|
-
|
470
|
||||||||||||
Issuance
of common stock for technology license
|
35,226,695
|
35,227
|
113,629
|
-
|
-
|
148,856
|
|||||||||||||
Net
loss for the year ended December 31, 2002
|
-
|
-
|
-
|
-
|
(618,137
|
)
|
(618,137
|
)
|
|||||||||||
Balance
at December 31, 2002
|
174,724,406
|
174,725
|
(25,389
|
)
|
-
|
(788,729
|
)
|
(639,393
|
)
|
||||||||||
Sale
of common stock for cash
|
61,463,911
|
61,464
|
2,398,145
|
-
|
-
|
2,459,609
|
|||||||||||||
Net
loss for the year ended December 31, 2003
|
-
|
-
|
-
|
-
|
(947,804
|
)
|
(947,804
|
)
|
|||||||||||
Balance
at December 31, 2003
|
236,188,317
|
236,189
|
2,372,756
|
-
|
(1,736,533
|
)
|
872,412
|
||||||||||||
Sale
of common stock for cash and stock subscription receivable
|
74,130,250
|
74,130
|
2,915,789
|
(2,750,000
|
)
|
-
|
239,919
|
||||||||||||
Cash
payments received on stock subscription receivable
|
-
|
-
|
-
|
750,000
|
-
|
750,000
|
|||||||||||||
Issuance
of common stock for technology license
|
2,470,998
|
2,471
|
97,529
|
-
|
-
|
100,000
|
|||||||||||||
Net
loss for the year ended December 31, 2004
|
-
|
-
|
-
|
-
|
(2,351,828
|
)
|
(2,351,828
|
)
|
|||||||||||
Balance
at December 31, 2004
|
312,789,565
|
312,790
|
5,386,074
|
(2,000,000
|
)
|
(4,088,361
|
)
|
(389,497
|
)
|
||||||||||
Cash
payments received on stock subscription receivable
|
-
|
-
|
-
|
1,500,000
|
1,500,000
|
||||||||||||||
Net
loss for the year ended December 31, 2005
|
-
|
-
|
-
|
-
|
(1,611,086
|
)
|
(1,611,086
|
)
|
|||||||||||
Balance
at December 31, 2005
|
312,789,565
|
312,790
|
5,386,074
|
(500,000
|
)
|
(5,699,447
|
)
|
(500,583
|
)
|
||||||||||
Cash
payments received on stock subscription receivable
|
-
|
-
|
-
|
500,000
|
-
|
500,000
|
|||||||||||||
Conversion
of GeoVax, Inc. preferred stock to common stock in connection with
merger
|
177,542,538
|
177,543
|
897,573
|
-
|
-
|
1,075,116
|
|||||||||||||
Common
shares issued to Dauphin Technology, Inc. in the merger on September
28,
2006
|
217,994,566
|
217,994
|
1,494,855
|
-
|
-
|
1,712,849
|
|||||||||||||
Issuance
of common stock for cashless warrant exercise
|
2,841,274
|
2,841
|
(2,841
|
)
|
-
|
-
|
-
|
||||||||||||
Net
loss for the year ended December 31, 2006
|
-
|
-
|
-
|
-
|
(584,166
|
)
|
(584,166
|
)
|
|||||||||||
Balance
at December 31, 2006
|
711,167,943
|
$
|
711,168
|
$
|
7,775,661
|
$
|
-
|
$
|
(6,283,613
|
)
|
$
|
2,203,216
|
See
accompanying report of independent registered public accounting firm and
notes
to financial statements.
F-6
GEOVAX
LABS. INC.
(A
DEVELOPMENT-STAGE ENTERPRISE)
CONSOLIDATED
STATEMENTS OF CASH FLOWS
Years
Ended December 31,
|
From
Inception
(June
27, 2001) to
December
31,
|
||||||||||||
2006
|
2005
|
2004
|
2006
|
||||||||||
Cash
flows from operating activities:
|
|||||||||||||
Net
loss
|
$
|
(584,166
|
)
|
$
|
(1,611,086
|
)
|
$
|
(2,351,828
|
)
|
$
|
(6,283,613
|
)
|
|
Adjustments
to reconcile net loss to net cash used in operating
activities
|
|||||||||||||
Depreciation
and amortization:
|
49,095
|
37,450
|
21,422
|
131,596
|
|||||||||
Accretion
of preferred stock redemption value
|
58,561
|
78,080
|
72,084
|
346,673
|
|||||||||
Changes
in assets and liabilities
|
|||||||||||||
Prepaid
expenses
|
124,701
|
(159,648
|
)
|
889
|
(38,130
|
)
|
|||||||
Deposits
|
-
|
-
|
-
|
(980
|
)
|
||||||||
Accounts
payable and accrued expenses
|
(123,227
|
)
|
(335,298
|
)
|
428,771
|
193,114
|
|||||||
Unearned
grant revenue
|
(852,905
|
)
|
183,433
|
314,519
|
-
|
||||||||
Total
adjustments
|
(743,775
|
)
|
(195,983
|
)
|
837,685
|
632,273
|
|||||||
Net
cash used in operating activities
|
(1,327,941
|
)
|
(1,807,069
|
)
|
(1,514,143
|
)
|
(5,651,340
|
)
|
|||||
Cash
flows from investing activities:
|
|||||||||||||
Purchase
of property and equipment
|
(69,466
|
)
|
(48,485
|
)
|
(7,070
|
)
|
(151,811
|
)
|
|||||
Net
cash used in investing activities
|
(69,466
|
)
|
(48,485
|
)
|
(7,070
|
)
|
(151,811
|
)
|
|||||
Cash
flows from financing activities:
|
|||||||||||||
Net
proceeds from sale of common stock
|
2,212,849
|
1,500,000
|
989,919
|
7,162,857
|
|||||||||
Net
proceeds from sale of preferred stock
|
-
|
-
|
-
|
728,443
|
|||||||||
Proceeds
from issuance of note payable
|
-
|
-
|
-
|
250,000
|
|||||||||
Repayment
of note payable
|
-
|
-
|
(250,000
|
)
|
|||||||||
Net
cash provided by financing activities
|
2,212,849
|
1,500,000
|
989,919
|
7,891,300
|
|||||||||
Net
increase (decrease) in cash and cash equivalents
|
815,442
|
(355,554
|
)
|
(531,294
|
)
|
2,088,149
|
|||||||
Cash
and cash equivalents at beginning of period
|
1,272,707
|
1,628,261
|
2,159,555
|
-
|
|||||||||
Cash
and cash equivalents at end of period
|
$
|
2,088,149
|
$
|
1,272,707
|
$
|
1,628,261
|
$
|
2,088,149
|
|||||
Supplemental
disclosure of cash flow information
|
|||||||||||||
Interest
paid
|
$
|
-
|
$
|
1,613
|
$
|
-
|
$
|
5,669
|
|||||
Supplemental
disclosure of non-cash investing and financing activities:
|
|||||||||||||
In
connection with the Merger discussed in Note 6, all of the outstanding
shares of the Company’s mandatory redeemable convertible preferred stock
were converted into shares of common stock as of September 28,
2006.
|
See
accompanying report of independent registered public accounting firm and
notes
to financial statements.
F-7
GEOVAX
LABS, INC.
(A
DEVELOPMENT-STAGE ENTERPRISE)
NOTES
TO CONSOLIDATED FINANCIAL STATEMENTS
Years
Ended December 31, 2006, 2005 and 2004, and
Period
from Inception (June 27, 2001) to December 31, 2006
1.
|
Description
of Company and Nature of
Business
|
GeoVax
Labs, Inc. (“GeoVax” or the “Company”), is a development stage biotechnology
company engaged in research and development activities with a mission to
develop, license and commercialize the manufacture and sale of human vaccines
for diseases caused by Human Immunodeficiency Virus and other infectious agents.
The Company has exclusively licensed from Emory University certain Acquired
Immune Deficiency Syndrome vaccine technology which was developed in
collaboration with the National Institutes of Health and the Centers for Disease
Control and Prevention.
GeoVax
was originally incorporated under the laws of Illinois as Dauphin Technology,
Inc. (“Dauphin”). Until December 2003, Dauphin marketed mobile hand-held,
pen-based computers and broadband set-top boxes and provided private,
interactive cable systems to the extended stay hospitality industry. The Company
was unsuccessful and its operations were terminated in December 2003. As further
discussed in Note 6, on September 28, 2006, Dauphin completed a merger (the
“Merger”) with GeoVax, Inc. which was incorporated on June 27, 2001 (date of
“inception”). Pursuant to the Agreement and Plan of Merger, GeoVax, Inc. merged
with and into GeoVax Acquisition Corp., a wholly-owned subsidiary of Dauphin.
As
a result of the Merger, the shareholders of GeoVax, Inc. exchanged their shares
of common stock for Dauphin common stock and GeoVax, Inc. became a wholly-owned
subsidiary of Dauphin. In connection with the Merger, Dauphin changed its name
to GeoVax Labs, Inc., replaced its officers and directors with those of GeoVax,
Inc. and moved its offices to Atlanta, Georgia. The Company currently does
not
plan to conduct any business other than GeoVax, Inc.’s business of developing
new products for the treatment of human diseases.
As
discussed in Note 2, the Company is a development-stage enterprise and is
devoting substantially all of its present efforts to research and development.
The Company has funded its activities to date almost exclusively from equity
financings and government grants received through Emory University. The Company
will continue to require substantial funds to continue research and development,
including preclinical studies and clinical trials of its product candidates,
and
to commence sales and marketing efforts, if the United States Food and Drug
Administration (“FDA”) or other regulatory approvals are obtained. In order to
meet its operating cash flow requirements management plans to consider
additional offerings of its common stock, debt or convertible debt instruments.
While the Company believes that it will be successful in obtaining the necessary
financing to fund its operations, there can be no assurances that such
additional funding will be achieved and that it will succeed in its future
operations. The accompanying financial statements have been prepared on a going
concern basis, which contemplates the realization of assets and the satisfaction
of liabilities and commitments in the normal course of business. These matters
raise substantial doubt about the Company’s ability to continue as a going
concern.
The
financial statements do not include any adjustments relating to the
recoverability and classification of recorded asset amounts or amounts of
liabilities that might be necessary should the Company be unable to continue
in
existence.
2.
|
Summary
of Significant Accounting
Policies
|
Basis
of Presentation and Principles of Consolidation
- As
more thoroughly discussed in Note 6, the accompanying consolidated financial
statements include the accounts of GeoVax, Inc. from inception together with
those of GeoVax Labs, Inc. from September 28, 2006. All intercompany
transactions have been eliminated in consolidation.
Development-Stage
Enterprise
-
The
Company is a development stage enterprise as defined by Statement of Financial
Accounting Standards (“SFAS”) No. 7, Accounting
and Reporting by Development Stage Enterprises.
All
losses accumulated since inception have been considered as part of the Company’s
development stage activities.
Use
of Estimates
- The
preparation of financial statements in conformity with accounting principles
generally accepted in the United States of America requires management to make
estimates and assumptions that affect the reported amounts of assets and
liabilities and disclosure of contingent assets and liabilities at the date
of
the financial statements and the reported amounts of revenues and expenses
during the reporting period. Actual results may differ from those
estimates.
F-8
Cash
and Cash Equivalents
- Cash
and cash equivalents consist of cash, bank deposits and highly liquid
investments with original maturities of three months or less at the date of
purchase. The recorded values approximate fair market values due to the short
maturities.
Property
and Equipment
-
Property and equipment are stated at cost. Expenditures for maintenance and
repairs are charged to operations as incurred, while additions and improvements
are capitalized. Depreciation is computed using the straight-line method over
the estimated useful lives of the assets which range from three to five years.
Depreciation expense was $24,210, $12,563 and $6,536 during the years ended
December 31, 2006, 2005 and 2004, respectively.
Other
Assets
- Other
assets consist principally of license agreements for the use of technology
obtained through the issuance of the Company’s common stock. These license
agreements are amortized on a straight line basis over ten years. Amortization
expense related to these agreements was $24,886, $24,886 and $14,886 during
the
years ended December 31, 2006, 2005 and 2004, respectively.
Impairment
of Long-Lived Assets
-
Long-lived assets are reviewed for impairment whenever events or changes in
circumstances indicate that the carrying amount of an asset may not be
recoverable. Recoverability of assets to be held and used is measured by a
comparison of the carrying amount of the assets to the future net cash flows
expected to be generated by such assets. If such assets are considered to be
impaired, the impairment to be recognized
is measured by the amount by which the carrying amount of the assets exceeds
the
discounted expected future net cash flows from the assets.
Restatement
for Recapitalization
- All
share amounts and per share figures in the accompanying consolidated financial
statements and the related footnotes have been restated for the recapitalization
discussed in Note 6, based on the 29.6521 exchange ratio indicated
therein.
Net
Loss Per Share
- Basic
and diluted loss per common share are computed based on the weighted average
number of common shares outstanding. Common share equivalents (which may consist
of options and warrants) are excluded from the computation of diluted loss
per
share since the effect would be antidilutive. Common share equivalents which
could potentially dilute basic earnings per share in the future, and which
were
excluded from the computation of diluted loss per share, totaled 33,689,729,
36,086,606 and 35,967,997 shares at December 31, 2006, 2005 and 2004,
respectively.
Revenue
Recognition
- The
Company’s revenue consists of subcontracted government grant revenue received
pursuant to collaborative arrangements with Emory University. Revenue from
these
collaborative research arrangements is deferred and recorded as income as the
related costs are incurred.
Research
and Development
- All
research and development costs, including legal fees and other direct costs
incurred in obtaining and protecting patents, related to future and present
products are charged to operations as incurred.
Period
to Period Comparisons
- The
Company’s operating results are expected to fluctuate for the foreseeable
future. Therefore, period-to-period comparisons should not be relied upon as
predictive of the results for future periods.
Income
Taxes
- The
Company accounts for income taxes using the liability method. Under this method,
deferred tax assets and liabilities are recognized for the estimated future
tax
consequences attributable to differences between the financial statement
carrying amounts of existing assets and liabilities and their respective tax
bases. Deferred tax assets and liabilities are measured using enacted rates
in
effect for the year in which temporary differences are expected to be recovered
or settled. Deferred tax assets are reduced by a valuation allowance unless,
in
the opinion of management, it is more likely than not that some portion or
all
of the deferred tax assets will be realized.
Stock-Based
Compensation
-
Effective January 1, 2006, the Company adopted SFAS No.123 (revised 2004),
Share-Based
Payments (“SFAS
No. 123R”), which requires the measurement and recognition of compensation
expense for all share-based payments made to employees and directors based
on
estimated fair values on the grant date. SFAS No. 123R replaces SFAS No. 123,
Accounting
for Stock-Based Compensation,
and
supersedes Accounting Principles Board (“APB”) Opinion No. 25, Accounting
for Stock Issued to Employees.
The
Company has adopted SFAS No. 123R using the prospective application method
which
requires the Company to apply the provisions of SFAS No. 123R prospectively
to
new awards and to awards modified, repurchased or cancelled after December
31,
2005. Awards granted after December 31, 2005 are valued at fair value in
accordance with the provisions of SFAS No. 123R and recognized on a straight
line basis over the service periods of each award. The
Company did not grant or modify any share-based compensation during the year
ended December 31, 2006.
F-9
Prior
to
January 1, 2006, the Company accounted for stock-based compensation using the
intrinsic value method in accordance with APB Opinion No. 25 and applied the
disclosure provisions of SFAS No. 123, as amended by SFAS No. 148, Accounting
for Stock-Based Compensation and Disclosure.
Under
those provisions, the Company provided pro forma disclosures as if the fair
value measurement provisions of SFAS No. 123 had been used in determining
compensation expense. The Company used a minimum value option-pricing model
to
determine the pro forma impact on the Company’s net income. This model utilizes
certain information, such as the interest rate on a risk-free security with
a
term generally equivalent to the expected life of the option being valued and
requires certain other assumptions, such as the expected amount of time an
option will be outstanding until it is exercised or expires, to calculate the
fair value of stock options granted.
The
adoption of SFAS No. 123R had no effect on Company’s net loss for the year ended
December 31, 2006. See Note 8 for additional stock-based compensation
information.
New
Accounting Pronouncements
-
In
June
2006, the Financial Accounting Standards Board (“FASB”) issued FASB
Interpretation No. 48, Accounting
for Uncertainty in Income Taxes--an interpretation of FASB Statement No.
109
(“FIN
No. 48”), which seeks to reduce the diversity in practice associated with the
accounting and reporting for uncertainty in income tax positions. This
Interpretation prescribes a comprehensive model for the financial statement
recognition, measurement, presentation and disclosure of uncertain tax positions
taken or expected to be taken in an income tax return. FIN No. 48 presents
a
two-step process for evaluating a tax position. The first step is to determine
whether it is more-likely-than-not that a tax position will be sustained upon
examination, based on the technical merits of the position. The second step
is
to measure the benefit to be recorded from tax positions that meet the
more-likely-than-not recognition threshold, by determining the largest amount
of
tax benefit that is greater than 50 percent likely of being realized upon
ultimate settlement, and recognizing that amount in the financial statements.
FIN No. 48 is effective for fiscal years beginning after December 15, 2006.
The
Company does not expect that the adoption of FIN No. 48 will have a material
impact on its results of operations, financial position, and cash
flows.
In
September 2006, the FASB issued SFAS No. 157, Fair
Value Measurements,
which
provides enhanced guidance for using fair value to measure assets and
liabilities. SFAS No.157 provides a common definition of fair value and
establishes a framework to make the measurement of fair value under generally
accepted accounting principles more consistent and comparable. SFAS No.157
also
requires expanded disclosures to provide information about the extent to which
fair value is used to measure assets and liabilities, the methods and
assumptions used to measure fair value, and the effect of fair value measures
on
earnings. SFAS No.157 is effective for financial statements issued in fiscal
years beginning after November 15, 2007. The Company is currently in the process
of evaluating the effect, if any, the adoption of SFAS No.157 will have on
its
results of operations, financial position, or cash flows.
3.
|
License
Agreements
|
During
2002, the Company entered into a license agreement with Emory University (the
“Emory License”), a related party, for technology required in conjunction with
certain products under development by the Company in exchange for 35,226,695
shares of the Company’s common stock valued at $148,856. The Emory License,
among other contractual obligations, requires payments based on milestone
achievements (as defined), royalties on sales by the Company or on payments
to
the Company by its sublicensees, and payment of maintenance fees in the event
certain milestones (as defined) are not met within the time periods specified
in
the contract. Additionally, prior patent costs are payable to Emory University,
one half of which is due when capital raised subsequent to the date of the
Emory
License is equal to $5 million and the remainder is due when cumulative capital
raised equals $12.5 million. The Company reached the first threshold of $5
million in December 2005, and fulfilled the first half of its payment obligation
($137,392) to Emory University in January 2006. The Company may terminate the
Emory License on three months’ written notice. In any event, the Emory License
expires on the date of the latest expiration date of the underlying
patents.
The
Company is obligated to reimburse Emory University for certain ongoing costs
in
connection with the filing, prosecution and maintenance of patent applications
subject to the Emory License. Such reimbursements to Emory amounted to $98,842,
$96,938 and $58,711 for the years ended December 31, 2006, 2005 and 2004,
respectively.
The
Company also entered into an additional license agreement during 2004 in
exchange for 2,470,998 shares of its common stock valued at $100,000. Pursuant
to this agreement, the Company obtained a fully paid, worldwide, irrevocable
exclusive license to certain patents covering technology that may be employed
by
the Company’s products.
F-10
4.
|
Lease
Commitment
|
The
Company leases the office and laboratory space used for its operations in
Atlanta under a lease agreement on a month-to-month basis from Emtech
Biotechnology Development, Inc., a related party associated with Emory
University. The Company also shares the lease expense for office space in the
Chicago area for one of its officers and directors, but is not obligated under
any lease agreement for such space. Rent expense amounted to $38,921, $27,444
and $25,488 for the years ended December 31, 2006, 2005 and 2004, respectively.
5.
|
Income
Taxes
|
At
December 31, 2006, the Company has a consolidated federal net operating loss
(“NOL”) carryforward of approximately $65.6 million, available to offset against
future taxable income which expires in varying amounts in 2010 through 2026.
Additionally, the Company has approximately $202,000 in research and development
(“R&D”) tax credits that expire in 2022 through 2025 unless utilized
earlier. No income taxes have been paid to date.
As
a
result of the Merger discussed in Note 6, the NOL carryforward at December
31,
2006 as disclosed herein has increased substantially over the amount shown
for
December 31, 2005 due to the addition of approximately $59.7 million of
historical NOL carryforwards for Dauphin.. However, Section 382 of the Internal
Revenue Code contains provisions that will limit the utilization of NOL and
R&D tax credit carryforwards in any given year as a result of significant
changes in ownership interests that have occurred in past periods or may occur
in future periods.
Deferred
income taxes reflect the net effect of temporary differences between the
carrying amounts of assets and liabilities for financial reporting purposes
and
the amounts used for income tax purposes. Significant components of the
Company’s deferred tax assets and liabilities included the following at December
31, 2006 and 2005:
2006
|
2005
|
||||||
Deferred
tax assets:
|
|||||||
Net
operating loss carryforward
|
$
|
22,531,019
|
$
|
2,058,324
|
|||
Research
and development credit carryforward
|
202,422
|
202,422
|
|||||
Other
|
13,600
|
-
|
|||||
Total
deferred tax assets
|
22,747,041
|
2,260,746
|
|||||
Deferred
tax liabilities
|
|||||||
Depreciation
|
6,601
|
3,520
|
|||||
Total
deferred tax liabilities
|
6,601
|
3,520
|
|||||
Net
deferred tax assets
|
22,740,440
|
2,257,226
|
|||||
Valuation
allowance
|
(22,740,440
|
)
|
(2,257,226
|
)
|
|||
|
$ | - |
$
|
-
|
The
Company has established a full valuation allowance equal to the amount of its
net deferred tax assets due to uncertainties with respect to its ability to
generate sufficient taxable income to realize these assets in the future.
A
reconciliation of the income tax benefit on losses at the U.S. federal statutory
rate to the reported income tax expense is as follows:
2006
|
2005
|
2004
|
||||||||
U.S.
federal statutory rate applied to pretax loss
|
$
|
(198,616
|
)
|
$
|
(547,769
|
)
|
$
|
(799,622
|
)
|
|
Permanent
differences
|
22,208
|
26,976
|
24,813
|
|||||||
Research
and development credits
|
-
|
74,636
|
73,128
|
|||||||
Change
in valuation allowance (excluding impact of the Merger discussed
in Note
6)
|
176,408
|
446,157
|
701,681
|
|||||||
Reported
income tax expense
|
$
|
-
|
$
|
-
|
$
|
-
|
F-11
6.
|
Merger
and Recapitalization
|
In
January 2006, Dauphin Technology, Inc. and GeoVax, Inc. entered into an
Agreement and Plan of Merger (the “Merger Agreement”), which was consummated on
September 28, 2006. In accordance with the Merger Agreement, as amended,
Dauphin’s wholly-owned subsidiary, GeoVax Acquisition Corp., merged with and
into GeoVax, Inc., which survived the merger and became a wholly-owned
subsidiary of Dauphin (the “Merger”). Dauphin then changed its name to GeoVax
Labs, Inc. Following the Merger, common shareholders of GeoVax, Inc. and holders
of GeoVax, Inc. redeemable convertible preferred stock received 29.6521 shares
of the Company’s common stock for each share of GeoVax, Inc. common or preferred
stock, or a total of 490,332,103 shares (approximately 69.2%) of the Company’s
708,326,669 shares of common stock then outstanding.
The
Merger was accounted for under the purchase method of accounting as a reverse
acquisition in accordance with accounting principles generally accepted in
the
United States for accounting and financial reporting purposes. Under this method
of accounting, Dauphin was treated as the “acquired” company. In accordance with
guidance applicable to these circumstances, the Merger was considered to be
a
capital transaction in substance. Accordingly, for accounting purposes, the
Merger was treated as the equivalent of GeoVax, Inc. issuing stock for the
net
monetary assets of Dauphin, accompanied by a recapitalization. The net monetary
assets of Dauphin (consisting primarily of cash) were stated at their fair
values, essentially equivalent to historical costs, with no goodwill or other
intangible assets recorded. The deficit accumulated during the development
stage
of GeoVax, Inc. was carried forward after the Merger. The accompanying
consolidated financial statements reflect the operations of GeoVax, Inc. prior
to the Merger, and of the combined companies subsequent to the
Merger.
As
a
condition of the Merger closing, Dauphin was required to have a minimum of
$2
million in net cash assets as of the closing date. Dauphin satisfied the $2
million net cash asset condition through the issuance, in June 2006, of two
promissory notes to an accredited investor, each in the principal amount of
$1
million, for aggregate proceeds of $2 million. These notes were converted into
shares of the Dauphin’s common stock prior to the Merger closing. Since these
transactions occurred prior to the Merger closing, in accordance with the
accounting treatment of the Merger, no effect is given to the transactions
in
the accompanying consolidated financial statements.
The
following pro forma information presents the results of operations of the
Company for the years ended December 31, 2006 and 2005 as if the Merger had
taken place on January 1, 2006 and January 1, 2005, respectively. These pro
forma results of operations have been prepared for comparative purposes only
and
do not purport to be indicative of the results of operations which actually
would have resulted had the Merger occurred on the dates indicated, or which
may
result in the future.
2006
|
2005
|
||||||
Revenue
|
$
|
852,905
|
$
|
670,467
|
|||
Net
loss
|
(3,171,441
|
)
|
(2,408,816
|
)
|
|||
Net
loss per common share
|
(0.00
|
)
|
(0.00
|
)
|
7.
|
Mandatory
Redeemable Convertible Preferred
Stock
|
In
December 2001 and February 2002, the Company issued 4,191,264 and 1,796,256
shares, respectively, of Series A Mandatory Redeemable Convertible Preferred
Stock (“Series A”) of GeoVax, Inc. for $.125 per share. Series A shares have
many significant rights and privileges, including mandatory redemption rights,
conversion rights and liquidation preferences. In connection with the Merger
discussed in Note 6, all of the then outstanding shares of Series A Preferred
Stock were converted into 177,542,538 shares of the Company’s common stock.
There are no outstanding shares of Series A Preferred Stock at December 31,
2006.
8.
|
Stockholders’
Equity
|
Common
Stock Transactions
In
March
2004, the Company sold 74,130,250 shares of its common stock for $3,000,000,
of
which $250,000 was paid in cash and $2,750,000 of which was paid through the
issuance of an installment subscription note collateralized by such shares.
As
of December 31, 2005, $500,000 of the stated installments under the subscription
note remained due and unpaid. The remaining $500,000 was paid in September
2006.
F-12
In
December 2004, the Company issued 2,470,998 shares of its common stock (valued
at $100,000) in connection with a license agreement (see Note 3).
In
November 2006, the Company issued 2,841,274 shares of its common stock in
connection with a cashless exercise of a previously issued stock purchase
warrant.
Stock
Options
In
connection with the Merger, the Board of Directors adopted, and the Company’s
shareholders approved, the GeoVax Labs, Inc. 2006 Equity Incentive Plan (the
“2006 Plan”) pursuant to which stock options designated as either incentive
(“ISO”) or nonqualified may be issued to employees, officers, directors,
consultants and advisors of the Company. The 2006 Plan also allows for the
grant
of restricted stock awards or restricted stock bonuses. The exercise price
for
any option granted may not be less than fair value (110% of fair value for
ISO’s
granted to certain employees). The 2006 Plan also allows for the grant of
restricted stock awards or restricted stock bonuses. Prior to adoption of the
2006 Plan, stock option awards were subject to the GeoVax, Inc. 2002 Stock
Plan
and Incentive Plan (the “2002 Plan”) which has been discontinued. All
outstanding stock options issued pursuant to the 2002 Plan were assumed by
the
2006 Plan. Options granted under the plans have a maximum ten-year term and
generally vest over four years. The Company has reserved 51,000,000 shares
of
its common stock for issuance under the 2006 Plan.
A
summary
of the Company’s stock option activity for 2006 and related information is as
follows:
Outstanding
Options
|
Weighted
Average
Exercise
Price
|
||||||
Balance,
December 31, 2003
|
8,895,631
|
$
|
0.04
|
||||
Granted
|
27,072,367
|
0.04
|
|||||
Exercised
|
--
|
--
|
|||||
Expired
|
--
|
--
|
|||||
Forfeited
|
--
|
--
|
|||||
Balance,
December 31, 2004
|
35,967,998
|
$
|
0.04
|
||||
Granted
|
296,521
|
0.04
|
|||||
Exercised
|
--
|
--
|
|||||
Expired
|
--
|
--
|
|||||
Forfeited
|
(177,913
|
)
|
0.04
|
||||
Balance,
December 31, 2005
|
36,086,606
|
$
|
0.04
|
||||
Granted
|
--
|
--
|
|||||
Exercised
|
--
|
--
|
|||||
Expired
|
--
|
--
|
|||||
Forfeited
|
(1,655,574
|
)
|
0.04
|
||||
Balance,
December 31, 2006
|
34,431,032
|
$
|
0.04
|
||||
Exercisable,
December 31, 2006
|
34,233,341
|
$
|
0.04
|
Additional
information concerning the Company’s stock options as of December 31, 2006 and
for the years ended December 31, 2006, 2005 and 2004 is presented
below:
December
31, 2006
|
|||||||
Total
Options
Outstanding
|
Options
Exercisable
|
||||||
Number
of options
|
34,431,032
|
34,233,341
|
|||||
Range
of exercise prices
|
$
|
0.04
|
$
|
0.04
|
|||
Weighted
average remaining contractual life
|
2.3
yrs
|
2.3
yrs
|
|||||
Aggregate
intrinsic value
|
$
|
6,453,737
|
$
|
6,416,269
|
Year
Ended December 31,
|
||||||||||
2006
|
2005
|
2004
|
||||||||
Weighted
average fair value of options granted during the period
|
$
|
-
|
$
|
0.01
|
$
|
0.02
|
||||
Total
fair value of options vested during the period
|
104,837
|
105,955
|
109,695
|
F-13
During
2006, the Company did not grant any stock options; therefore, fair value
calculations were not required. During 2005 and 2004 (prior to adoption of
SFAS
No. 123R) the Company used a minimum value option-pricing model to estimate
the
fair values of stock option grants. This model utilizes certain information,
such as the interest rate on a risk-free security with a term generally
equivalent to the expected life of the option being valued and requires certain
other assumptions, such as the expected amount of time an option will be
outstanding until it is exercised or expired, to calculate the fair value of
stock options granted. The significant assumptions used by the Company in its
fair value calculations were as follows:
2006
|
2005
|
2004
|
||||
Weighted
average risk-free interest rates
|
-
|
4.0%
|
3.3%
|
|||
Expected
dividend yield
|
-
|
0.0%
|
0.0%
|
|||
Expected
life of option
|
-
|
8.0
yrs
|
5.7
yrs
|
|||
Expected
volatility
|
-
|
25%
|
25%
|
The
Company recorded no stock-based compensation expense during the years ended
December 31, 2006, 2005 and 2004. Since the Company granted no stock options
during 2006, and adopted SFAS No.123R using the prospective method (See Note
2),
as of December 31, 2006, there was no unrecognized compensation costs related
to
stock options.
9.
|
Retirement
Plan
|
The
Company participates in a multi-employer defined contribution retirement plan
(the “401k Plan”) administered by a third party service provider, and has
contributed to the 401k Plan on behalf of its employees based upon a matching
formula. During the years ended December 31, 2006, 2005 and 2004 Company
contributions to the 401k Plan were $6,744, $7,473 and $5,597,
respectively.
10.
|
Selected
Quarterly Financial Data
(unaudited)
|
A
summary
of selected quarterly financial data for 2006 and 2005 is as
follows:
2006
Quarter Ended
|
|||||||||||||
March
31
|
June
30
|
September
30
|
December
31
|
||||||||||
Revenue
from grants
|
$
|
-
|
$
|
478,853
|
$
|
-
|
$
|
374,052
|
|||||
Net
income (loss)
|
(432,856
|
)
|
196,163
|
(283,434
|
)
|
(64,039
|
)
|
||||||
Net
income (loss) per share
|
(0.00
|
)
|
(0.00
|
)
|
(0.00
|
)
|
(0.00
|
)
|
2005
Quarter Ended
|
|||||||||||||
March
31
|
June
30
|
September
30
|
December
31
|
||||||||||
Revenue
from grants
|
$
|
165,327
|
$
|
56,672
|
$
|
432,526
|
$
|
15,942
|
|||||
Net
income (loss)
|
(302,811
|
)
|
(569,815
|
)
|
(161,941
|
)
|
(576,519
|
)
|
|||||
Net
income (loss) per share
|
(0.00
|
)
|
(0.00
|
)
|
(0.00
|
)
|
(0.00
|
)
|
11.
|
Subsequent
Events
|
In
January 2007, the Company sold 1,543,210 shares of its common stock for an
aggregate purchase price of $250,000. In connection with the sale, the Company
issued to the investors stock purchase warrants to purchase an aggregate of
771,605 shares of the Company’s common stock at $0.75 per share. Such warrants
expire on December 31, 2009. The shares issued pursuant to this transaction
were
unregistered and the investors were granted limited (piggyback) registration
rights.
F-14
GEOVAX
LABS, INC.
SCHEDULE
II - VALUATION AND QUALIFYING ACCOUNTS
For
the Years Ended December 31, 2006, 2005 and 2004
Additions
|
||||||||||||||||
Description
|
Balance
at
Beginning
Of
Period
|
Charged
to
Costs
and
Expenses
|
Charged
to
Other
Accounts
|
Deductions
|
Balance
at
End
Of
Period
|
|||||||||||
Reserve
Deducted in the Balance Sheet From the Asset to Which it
Applies:
|
||||||||||||||||
Allowance
for Deferred Tax Assets
|
||||||||||||||||
Year
ended December 31, 2006
|
$
|
2,257,226
|
$
|
20,483,214
|
$
|
-
|
$
|
-
|
$
|
22,740,440
|
||||||
Year
ended December 31, 2005
|
1,600,555
|
656,671
|
-
|
-
|
2,257,226
|
|||||||||||
Year
ended December 31, 2004
|
661,282
|
939,273
|
-
|
-
|
1,600,555
|
F-15