424B3
Filed Pursuant to Rule 424(b)(3)
Registration No. 333-151491
PROSPECTUS
GEOVAX LABS, INC.
40,161,020 Shares of Common Stock
This prospectus relates to the sale of up to 40,161,020 shares of our common stock, $0.001 par
value, by Fusion Capital Fund II, LLC (Fusion Capital). Fusion Capital is sometimes referred to
in this prospectus as Fusion or the selling stockholder. The prices at which Fusion Capital may
sell the shares will be determined by the prevailing market price for the shares or in negotiated
transactions. We will not receive proceeds from the sale of our shares by Fusion Capital.
Our common stock is registered under Section 12(g) of the Securities Exchange Act of 1934 and
quoted on the over-the-counter bulletin board under the symbol GOVX. On June 9, 2009, the last
reported sale price for our common stock as reported on the over-the-counter bulletin board was
$0.26 per share.
Investing in the common stock involves certain risks. See Risk Factors beginning on page 3
for a discussion of these risks.
The selling stockholder is an underwriter within the meaning of the Securities Act of 1933,
as amended.
Neither the Securities and Exchange Commission nor any state securities commission has
approved or disapproved of these securities or determined if this prospectus is truthful or
complete. Any representation to the contrary is a criminal offense.
The date of this Prospectus is June 10, 2009
TABLE OF CONTENTS
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F-1 |
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You should rely only on the information contained in this prospectus and in any
accompanying prospectus supplement. We have not authorized anyone to provide you with
different information.
We have not authorized the selling stockholder to make an offer of these shares of
common stock in any jurisdiction where the offer is not permitted.
You should not assume that the information in this prospectus or prospectus supplement
is accurate as of any date other than the date on the front of this prospectus.
i
PROSPECTUS SUMMARY
You should rely only on the information contained in this prospectus and in any prospectus
supplement. We have not authorized anyone else to provide you with different information, and if
you receive any unauthorized information you should not rely on it. We have not authorized the
selling stockholder to make an offer of these shares in any place where the offer is not permitted.
The information appearing in this prospectus or any prospectus supplement is accurate only as of
its date. Our business, financial condition, results of operations and prospects may have changed
since that date.
Business
GeoVax Labs, Inc. 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. We have exclusively licensed from Emory University certain Acquired Immune
Deficiency Syndrome (AIDS) vaccine technology that was developed in collaboration with the
National Institutes of Health (NIH) and the Centers for Disease Control and Prevention.
Our HIV vaccine candidates have successfully completed preclinical efficacy testing in
non-human primates and Phase 1 clinical testing trials in humans. A Phase 2a human clinical trial
for our preventative HIV vaccine candidate was initiated during the fourth quarter of 2008, and
patient enrollment commenced in February 2009. The costs of conducting our human clinical trials to
date have been borne by the HIV Vaccine Trials Network ( HVTN), with GeoVax incurring costs
associated with manufacturing the clinical vaccine supplies and other study support.
Our vaccines, initially developed by Dr. Harriet L. Robinson at Emory University in
collaboration with researchers at the NIH, National Institute of Allergy and Infectious Disease
(NIAID), and the United States Centers for Disease Control (CDC), are recombinant DNA
(deoxyribonucleic acid) and MVA (Modified Vaccinia Ankara) vaccines. Our focus is on developing
AIDS vaccines comprising the major HIV-1 subtypes (A, B and C). These vaccines could be used alone
or as combinations depending on a local infection. Subtype B is most common in North America, the
EU, Japan and Australia and is our first priority.
When properly administered in series, these AIDS vaccines induce strong cellular and humoral
immunity (protection) in non-human primates against multiple HIV-1 proteins (AIDS virus
components). This suggests that our vaccines could provide protection against the development of
AIDS in HIV-1 virus infected people.
The Offering
On May 8, 2008, we entered into a common stock purchase agreement (the Purchase Agreement)
with Fusion Capital Fund II, LLC, an Illinois limited liability company (Fusion Capital or
Fusion). Under the Purchase Agreement, Fusion Capital is obligated, under certain conditions, to
purchase shares from us in an aggregate amount of up to $10.0 million from time to time over a
twenty-five (25) month period. Under the terms of the Purchase Agreement, Fusion Capital received a
commitment fee consisting of 2,480,510 shares of our common stock. Also, we agreed to issue to
Fusion Capital up to an additional 2,480,510 shares as a commitment fee pro rata as we received the
up to $10.0 million of future funding. We have issued 267,896 of the 2,480,510 shares as of June 9,
2009.
As of June 9, 2009, we have sold an aggregate of 8,682,211 shares to Fusion Capital and
received proceeds of $1,080,000. As of June 9, 2009, 752,564,992 shares of our common stock were
outstanding (including shares held by non-affiliates) excluding the up to 28,530,403 of the shares
offered by Fusion Capital pursuant to this prospectus which we have not yet issued to Fusion
Capital. If all of such 28,530,403 shares were issued and outstanding as of the date hereof, the
40,161,020 shares offered hereby would represent 5.1% of the total common stock outstanding or
10.3% of the non-affiliate shares outstanding as of the date hereof. The number of shares
ultimately offered for sale by Fusion Capital is dependent upon the number of shares purchased by
Fusion Capital under the Purchase Agreement.
Under the Purchase Agreement and the related registration rights agreement we are required to
register and have included in the offering for resale by Fusion Capital pursuant to this
prospectus:
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2,480,510 shares which were issued as a commitment fee; |
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200,000 shares which we issued to Fusion Capital as an expense reimbursement; |
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an additional 2,480,510 shares which we may issue in the future as a commitment fee
pro rata as we receive the up to $10.0 million of future funding; and |
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35.0 million shares which we may sell to Fusion Capital. |
All 40,161,020 shares are being offered pursuant to this prospectus. Under the Purchase
Agreement, we have the right but not the obligation to sell more than the 35.0 million shares to
Fusion Capital. As of the date hereof, we do not have any plans or intent to sell to Fusion Capital
any shares beyond this 35.0 million shares. However, if we elect to sell more than the 35.0 million
shares, we must first register under the Securities Act of 1933 (the Securities Act) any
additional shares we may elect to sell to Fusion Capital before we can sell such additional shares,
which could cause substantial dilution to our stockholders.
We did not have the right to commence any sales of our shares to Fusion Capital until the SEC
declared effective the registration statement of which this prospectus is a part. The registration
statement was declared effective on July 1, 2008 and the conditions to commence funding were
satisfied. Generally, we have the right but not the obligation from time to time to sell our shares
to Fusion Capital in amounts between $80,000 and $1.0 million depending on certain conditions. We
have the right to control the timing and amount of any sales of our shares to Fusion Capital,
subject to certain limitations. The purchase price of the shares will be determined pursuant to a
formula based upon the market price of our shares without any fixed discount at the time of each
sale. Fusion Capital shall not have the right nor the obligation to purchase any shares of our
common stock on any business day that the price of our common stock is below $0.05. There are no
negative covenants, restrictions on future fundings, penalties or liquidated damages in the
Purchase Agreement or the registration rights agreement. The Purchase Agreement may be terminated
by us at any time at our discretion without any cost to us.
We were an Illinois corporation. On March 11, 2008 our Board of Directors determined that it
would be in the best interests of our company and our shareholders to reincorporate in Delaware. In
order to accomplish this reincorporation, we formed a corporation in Delaware called GeoVax Labs,
Inc.
In conjunction with the reincorporation in Delaware our Board of Directors unanimously adopted
and approved an Agreement and Plan of Merger of GeoVax Labs, Inc., an Illinois corporation, and
GeoVax Labs, Inc., a Delaware corporation (the Reincorporation Merger Agreement). We submitted
the reincorporation proposal to our shareholders. The reincorporation was approved by them and the
reincorporation merger was consummated on June 18, 2008.
As used herein, GeoVax, the Company, we, our and similar terms include GeoVax Labs,
Inc., an Illinois corporation, and its subsidiaries, and after the reincorporation includes GeoVax
Labs, Inc., a Delaware corporation, unless the context indicates otherwise.
Our principal executive offices are located at 1256 Briarcliff Road NE, Atlanta, Georgia
30306. Our telephone number is (404) 727-0971. The address of our website is
www.geovax.com . Information on our website is not part of this prospectus.
2
RISK FACTORS
You should carefully consider the risks, uncertainties and other factors described below
before you decide whether to buy shares of our common stock. Any of the factors could materially
and adversely affect our business, financial condition, operating results and prospects and could
negatively impact the market price of our common stock. Also, you should be aware that the risks
and uncertainties described below are not the only ones we face. Additional risks and
uncertainties, of which we are not yet aware, or that we currently consider to be immaterial, may
also impair our business operations. You should also refer to the other information contained in
and incorporated by reference into this prospectus, including our financial statements and the
related notes.
Risks Related to Our Financial Results and Need for Additional Financing
We have a history of operating losses, and we expect losses to continue for the foreseeable future.
Our ability to generate revenue and achieve profitability depends on our ability to
successfully develop our product candidates, conduct preclinical tests and clinical trials, obtain
the necessary regulatory approvals and manufacture and market the resulting products. We have had
no product revenue to date. We have experienced operating losses since we began operations in 2001.
As of March 31, 2009, we had an accumulated deficit of approximately $15.1 million. We expect to
incur additional operating losses and expect cumulative losses to increase as our research and
development, preclinical, clinical, manufacturing and marketing efforts expand.
Our business will require continued funding. If we do not receive adequate funding, we will not be
able to continue our operations.
To date, we have financed our operations principally through the private placement of equity
securities and through government grants. 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
delay clinical studies, curtail operations or obtain funds through collaborative arrangements that
may require us to relinquish rights to some of our products or potential markets.
We only have the right to receive $80,000 every 4 business days under the Purchase Agreement
with Fusion Capital unless the market price of our stock equals or exceeds $0.11, in which case we
can sell greater amounts to Fusion Capital as the market price of our common stock increases.
Fusion Capital does not have the right nor the obligation to purchase any shares of our common
stock on any business day that the market price of our common stock is less than $0.05. The
40,161,020 shares we registered for sale by Fusion Capital pursuant to this prospectus include a
total of 35.0 million of our shares for sale by us to Fusion Capital for cash, of which
approximately 26.3 million remain available for sale to Fusion Capital at June 9, 2009. Our sale
price of these shares to Fusion Capital will have to average at least $0.34 per share for us to
receive the maximum remaining proceeds of $8.9 million. Depending on the prevailing market price of
our common stock and its trading volume, we may be unable to access the full remaining amount
available from Fusion Capital prior to expiration of the Purchase Agreement, unless we choose to
register and sell more shares, which we have the right, but not the obligation, to do. Subject to
approval by our Board of Directors, we have the right but not the obligation to sell more than 35.0
million shares to Fusion Capital. In the event we elect to sell more than 35.0 million shares, we
will be required to file a new registration statement and have it declared effective by the U.S.
Securities & Exchange Commission.
The extent we rely on Fusion Capital as a source of funding will depend on a number of factors
including, the prevailing market price of our common stock and the extent to which we are able to
secure working capital from other sources, such as through the sale of our products. Specifically,
Fusion Capital does not have the right nor the obligation to purchase any shares of our common
stock on any business days that the stock sale price of our common stock is less than $0.05. If
obtaining sufficient financing from Fusion Capital proves unavailable or prohibitively dilutive and
if we are unable to commercialize and sell enough of our products, we will need to secure another
source of funding in order to satisfy our working capital needs. Even if we are able to access the
full $10.0 million under the Purchase Agreement with Fusion Capital, we may still need additional
capital to fully implement our business, operating and development plans. Should the financing we
require to sustain our working capital needs be unavailable or prohibitively expensive when we
require it, the consequences could be a material adverse effect on our business, operating results,
financial condition and prospects.
3
The current economic downturn may adversely impact our ability to raise capital.
The recent economic downturn and adverse conditions in the national and global markets may
negatively affect our operations in the future. The falling equity markets and adverse credit
markets may make it difficult for us to raise capital or procure credit in the future to fund the
growth of our business, which could have a negative impact on our business and results of
operations.
Risks Related to Development and Commercialization of Product Candidates and Dependence on Third
Parties
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.
Furthermore, if we enter into an agreement with Vivalis S.A. (see Business Manufacturing), our
collaboration may not result in a commercially advantageous method for producing our MVA vaccine
component. If we cannot successfully develop and prove our products and processes, 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 product 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. Although we have
recognized revenues from government grants, there can be no assurance that we will ever generate
significant product revenues.
Whether we are successful will be dependent, in part, upon the leadership provided by our
management. If we were to lose the services of any of these individuals, our business and
operations may be adversely affected.
Whether our business will be successful will be dependent, in part, upon the leadership
provided by our officers, particularly our Chairman, President and Chief Executive Officer, members
of our Board of Directors and our primary scientist. The loss of the services of these individuals
may have an adverse effect on our operations.
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 meet than FDA requirements. 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 developing and distribution of 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 with
substantially greater resources than us. 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 broad revenue bases
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:
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the efficacy and safety of our vaccines; |
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the time and scope of regulatory approval; |
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reimbursement coverage from insurance companies and others; |
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the price and cost-effectiveness of our products; and |
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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
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.
Because we cannot predict whether or when we will obtain regulatory approval to commercialize our
product candidates, we cannot predict the timing of any future revenue from these product
candidates.
We cannot commercialize any of our product candidates until the appropriate regulatory
authorities have reviewed and approved the applications for the product candidates. The regulatory
agencies may not complete their review processes in a timely manner and we may not obtain
regulatory approval for any product candidate we or our collaborators develop. Satisfaction of
regulatory requirements typically takes many years, if approval is obtained at all, is dependent
upon the type, complexity and novelty of the product and requires the expenditure of substantial
resources. Regulatory approval processes outside the United States may include all of the risks
associated with the FDA approval process. In addition, we may experience delays or rejections based
upon additional government regulation from future legislation or administrative action or changes
in FDA policy during the period of product development, clinical trials and FDA regulatory review.
The FDA has substantial discretion in the approval process and may refuse to accept any application
or may decide that our data is insufficient for approval and require additional preclinical,
clinical or other studies. In addition, varying interpretations of the data obtained from
preclinical and clinical testing could delay, limit or prevent regulatory approval of a product
candidate.
We may experience delays in our clinical trials that could adversely affect our financial results
and our commercial prospects.
We do not know whether planned clinical trials will begin on time or whether we will complete
any of our clinical trials on schedule or at all. Product development costs will increase if we
have delays in testing or approvals or if we need to perform more or larger clinical trials than
planned. Significant delays may adversely affect our financial results and the commercial prospects
for our products, and delay our ability to become profitable.
We rely heavily on the HIV Vaccine Trials Network (HVTN), independent clinical investigators,
and other third party service providers for successful execution of our clinical trials, but do not
control many aspects of their activities. We are responsible for ensuring that each of our clinical
trials is conducted in accordance with the general investigational plan and protocols for the
trial. Moreover, the FDA requires us to comply with standards, commonly referred to as Good
Clinical Practices, for conducting and recording and reporting the results of clinical trials to
assure that data and reported results are credible and accurate and that the rights, integrity and
confidentiality of trial participants are protected. Our reliance on third parties that we do not
control does not relieve us of these responsibilities and requirements. Third parties may not
complete activities on schedule, or may not conduct our clinical trials in accordance with
regulatory requirements or our stated protocols. The failure of these third parties to carry out
their obligations could delay or prevent the development, approval and commercialization of our
product candidates.
5
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 sale 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.
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 states 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.
6
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. 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. In addition, 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.
We may not be successful in establishing collaborations for product candidates we may seek to
commercialize, which could adversely affect our ability to discover, develop and commercialize
products.
We expect to seek collaborations for the development and commercialization of product
candidates in the future. The timing and terms of any collaboration will depend on the evaluation
by prospective collaborators of the trial results and other aspects of our vaccines safety and
efficacy profile. If we are unable to reach agreements with suitable collaborators for any product
candidate, we would be forced to fund the entire development and commercialization of such product
candidates, and we may not have the resources to do so. If resource constraints require us to enter
into a collaboration early in the development of a product candidate, we may be forced to accept a
more limited share of any revenues that product may eventually generate. We face significant
competition in seeking appropriate collaborators. Moreover, collaboration arrangements are complex
and time-consuming to negotiate and document. We may not be successful in our efforts to establish
collaborations or other alternative arrangements for any product candidate. Even if we are
successful in establishing collaborations, we may not be able to ensure fulfillment by
collaborators of their obligations or our expectations.
We do not have sales and marketing experience and our lack of experience may restrict our success
in commercializing our product candidates.
We do not have experience in marketing or selling vaccines. We may be unable to establish
satisfactory arrangements for marketing, sales and distribution capabilities necessary to
commercialize and gain market acceptance for our products. Obtaining the expertise necessary to
successfully market and sell our vaccines will require the development of our own commercial
infrastructure and/or collaborative commercial arrangements and partnerships. Our ability to make
that investment and also execute our current operating plan is dependent on numerous factors,
including the performance of third party collaborators with whom we may contract. Accordingly, we
may not have sufficient funds to successfully commercialize our vaccines in the United States or
elsewhere.
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 managements attention, and adversely affect our reputation and the demand
for our products.
Risks Related to Our Intellectual Property
Other parties 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.
Pharmaceutical companies, biotechnology companies, universities, research institutions or other
third parties may have filed patent applications or may have patents that cover aspects of our
products or our licensors products, product candidates or other technologies.
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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:
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stop or delay selling, manufacturing or using products that incorporate or are made
using the challenged intellectual property; |
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pay damages; or |
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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 very 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. 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.
Risks Related to Our Common Stock
The sale of our common stock to Fusion Capital may cause dilution and the sale of the shares of
common stock acquired by Fusion Capital could cause the price of our common stock to decline.
In connection with entering into the Purchase Agreement, we authorized the sale to Fusion
Capital of up to 35.0 million shares of our common stock. The number of shares ultimately offered
for sale by Fusion Capital under this prospectus is dependent upon the number of shares purchased
by Fusion Capital under the Purchase Agreement. The purchase price for the common stock to be sold
to Fusion Capital pursuant to the Purchase Agreement will fluctuate based on the price of our
common stock. All 40,161,020 shares registered in this offering are expected to be freely tradable
when sold pursuant to this prospectus. It is anticipated that shares registered in this offering
will be sold over a period of up to 25 months from July 1, 2008. The 2,480,510 shares issued as an
initial commitment fee may not be sold by Fusion Capital until the earlier of 500 days after May 8,
2008, or the termination of the Purchase
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Agreement, subject to certain exceptions. Depending upon market liquidity at the time, a sale
of shares under this offering at any given time could cause the trading price of our common stock
to decline. Fusion Capital may ultimately acquire all, some or none of the 28,530,403 shares of
common stock not yet issued but registered in this offering. After it has acquired such shares,
Fusion Capital may sell all, some or none of such shares. Therefore, sales to Fusion Capital by us
under the Purchase Agreement may result in substantial dilution to the interests of other holders
of our common stock.
The Purchase Agreement with Fusion Capital may adversely impact our other fundraising initiatives.
The sale of a substantial number of shares of our common stock under this offering, or
anticipation of such sales, could make it more difficult for us to sell equity or equity-related
securities in the future at a time and at a price that we might otherwise wish to effect sales.
However, we have the right to control the timing and amount of any sales of our shares to Fusion
Capital and the Purchase Agreement may be terminated by us at any time at our discretion without
any cost to us.
The market price of our common stock is highly volatile.
The market price of our common stock has been and is expected to continue to be highly
volatile. Factors, including announcements of technological innovations by us or other companies,
regulatory matters, new or existing products or procedures, concerns about our financial position,
operating results, litigation, government regulation, developments or disputes relating to
agreements, patents or proprietary rights, may have a significant impact on the market price of our
stock. In addition, potential dilutive effects of future sales of shares of common stock by
stockholders and by the Company, including Fusion Capital pursuant to this prospectus and
subsequent sale of common stock by the holders of warrants and options could have an adverse effect
on the market price of our shares.
Our common stock is and likely will remain subject to the SECs Penny Stock rules, which may make
our shares more difficult to sell.
Because the price of our common stock is currently and may remain less than $5.00 per share,
it is classified as a penny stock. The SEC rules regarding penny stocks may have the effect of
reducing trading activity in our shares, making it more difficult for investors to sell. Under
these rules, broker-dealers who recommend such securities to persons other than institutional
accredited investors must:
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make a special written suitability determination for the purchaser; |
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receive the purchasers written agreement to a transaction prior to sale; |
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provide the purchaser with risk disclosure documents which identify certain risks
associated with investing in penny stocks and which describe the market for these
penny stocks as well as a purchasers legal remedies; |
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obtain a signed and dated acknowledgement from the purchaser demonstrating that the
purchaser has received the required risk disclosure document before a transaction in a
penny stock can be completed; and |
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give bid and offer quotations and broker and salesperson compensation information to
the customer orally or in writing before or with the confirmation. |
These rules make it more difficult for broker-dealers to effectuate customer transactions and
trading activity in our securities and may result in a lower trading volume of our common stock and
lower trading prices.
The sale of our common stock to Fusion Capital may not be possible when we need it, thus limiting
our ability to continue our product development and commercialization.
The Purchase Agreement may be terminated in the event of a default under the agreement. In
addition, we may not require Fusion Capital to purchase any shares of our common stock if the
purchase price is less than $0.05 per share. Thus, we may be unable to sell shares of our common
stock to Fusion Capital when we need the funds, and that could severely harm our business and
financial condition and our ability to continue to develop and commercialize our products. See The
Fusion Transaction.
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FORWARD-LOOKING STATEMENTS
The information contained in this prospectus, including the information incorporated by
reference into this prospectus, includes forward-looking statements as defined in the Private
Securities Reform Act of 1995. These forward-looking statements are often identified by words such
as may, will, expect, intend, anticipate, believe, estimate, continue, plan and
similar expressions. These statements involve estimates, assumptions and uncertainties that could
cause actual results to differ materially from those expressed for the reasons described in this
prospectus. You should not place undue reliance on these forward-looking statements.
You should be aware that our actual results could differ materially from those contained in
the forward-looking statements due to a number of factors, including:
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We have a history of operating losses, and we expect losses to continue for the
foreseeable future; |
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Our business will require continued funding. If we do not receive adequate funding,
we will not be able to continue our operations; |
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Our products are still being developed and are unproven. These products may not be
successful; |
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We have sold no products or generated any product revenues and we do not anticipate
any significant revenues to be generated in the foreseeable future; |
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Whether we are successful will be dependent, in part, upon the leadership provided by
our management. If we were to lose the services of any of these individuals, our
business and operations may be adversely affected; |
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Regulatory and legal uncertainties could result in significant costs or otherwise
harm our business; |
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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; |
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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; |
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Because we cannot predict whether or when we will obtain regulatory approval to
commercialize our product candidates, we cannot predict the timing of any future revenue
from these product candidates; |
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We may experience delays in our clinical trials that could adversely affect our
financial results and our commercial prospects; |
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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; |
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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; |
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We will face uncertainty related to pricing and reimbursement and health care reform; |
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We do not have sales and marketing experience and our lack of experience may restrict
our success in commercializing our product candidates; |
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We may be required to defend lawsuits or pay damages for product liability claims; |
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Other parties 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; |
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The sale of our common stock to Fusion Capital may cause dilution and the sale of the
shares of common stock acquired by Fusion Capital could cause the price of our common
stock to decline; and |
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Our common stock is and may remain subject to the SECs Penny Stock rules, which
may make our shares more difficult to sell. |
You should also consider carefully the statements under Risk Factors and other sections of
this prospectus, which address additional factors that could cause our actual results to differ
from those set forth in the forward-looking statements and could materially and adversely affect
our business, operating results and financial condition. All subsequent written and oral
forward-looking statements attributable to us or persons acting on our behalf are expressly
qualified in their entirety by the applicable cautionary statements.
The forward-looking statements speak only as of the date on which they are made, and, except
to the extent required by federal securities laws, we undertake no obligation to update any
forward-looking statement to reflect events or circumstances after the date on which the statement
is made or to reflect the occurrence of unanticipated events. In addition, we cannot assess the
impact of each factor on our business or the extent to which any factor, or combination of factors,
may cause actual results to differ materially from those contained in any forward-looking
statements.
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BUSINESS
GeoVax Labs, Inc. (GeoVax or the Company) is a clinical stage biotechnology company
focused on developing human vaccines for diseases caused by Human Immunodeficiency Virus (HIV)
and other infectious agents. We have exclusively licensed from Emory University certain Acquired
Immune Deficiency Syndrome (AIDS) vaccine technology that was developed in collaboration with the
National Institutes of Health and the Centers for Disease Control and Prevention.
Our primary business is conducted by our subsidiary, GeoVax, Inc., which was incorporated
under the laws of Georgia in June 2001. The parent company, GeoVax Labs, Inc. (the reporting
entity) was originally incorporated in June 1988 under the laws of Illinois as Dauphin Technology,
Inc. (Dauphin). Dauphin was unsuccessful and its operations were terminated in December 2003. In
September 2006, Dauphin completed a merger (the Merger) with GeoVax, Inc. 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. Unless otherwise indicated,
information for periods prior to the September 2006 merger is that of GeoVax, Inc. In June 2008,
the Company was reincorporated under the laws of Delaware. We currently do not conduct any business
other than GeoVax, Inc.s business of developing new products for the treatment or prevention of
human diseases.
Overview of HIV/AIDS
What is HIV?
HIV (human immunodeficiency virus) is a retrovirus that carries its genetic code in the form
of RNA (ribonucleic acid). Retroviruses use RNA and the reverse transcriptase enzyme to create DNA
(deoxyribonucleic acid) from the RNA template. The HIV virus invades a human cell and produces its
viral DNA which is subsequently inserted into the genetic material (chromosomes) of the cell. This
infection converts helper T-cells (a type of white blood cell) from immunity producing cells into
cells that produce and release HIV virus particles into the blood stream, destroying the immune
defense system of the individual.
There are several AIDS-causing HIV-1 virus subtypes, or clades, that are found in different
regions of the world. These subtypes are identified as subtype A, subtype B on through C, D, E, F,
etc. The predominant subtype found in Europe, North America, South America, Japan and Australia is
B whereas the predominant subtypes in Africa are A and C. 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 only be partially effective against
other subtypes.
HIV-1, even within subtypes, has a high rate of variation or mutation. In drug treatment
programs, virus mutation can result in virus escape, thereby rendering drug therapy ineffective.
Hence, multi-drug therapy is very important. If several drugs are active against virus replication,
the virus must undergo multiple simultaneous mutations to escape which is less likely. The same is
true for immune responses. HIV-1 can escape single target immune responses. However, if an immune
response is directed against multiple targets (epitopes), virus escape is much less frequent.
Vaccination against more than one of the proteins found in HIV-1 increases the number of targets
for the immune response as well as the chance that HIV-1 will not escape the vaccine-stimulated
immune response, thus resulting in protection against clinical AIDS.
What is AIDS?
AIDS is the final, life-threatening stage of infection with the virus known as HIV-1.
Infection with HIV-1 severely damages the immune system, the bodys defense against disease. HIV-1
infects and gradually destroys T-cells and macrophages, which are white blood cells that play key
roles in protecting humans against infectious disease caused by viruses, bacteria, fungi 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-1 infections. Destruction of
the immune system occurs over years; the average onset of the clinical disease recognized as AIDS
occurs after 3-10 years of HIV-1 infection but can be earlier or later.
AIDS in humans was first identified in the US in 1981, but researchers believe that it was
present in Central Africa as early as 1959. AIDS is most often transmitted sexually from one person
to another but it is also transmitted by blood in shared needles (drug users) and through pregnancy
and childbirth. Heterosexual activity is the most frequent route of transmission worldwide.
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The level of virus in blood (viral load) is the best indicator of the speed with which an
individual will progress to AIDS, as well as the frequency with which an individual will spread
infection. An estimated 1% or fewer of those infected have low enough levels of the virus to
preclude progression to disease and to not transmit the infection. (These individuals are called
long-term non-progressors.)
AIDS is considered by many in the scientific and medical community to be the most lethal
infectious disease in the world. According to the 2007 Report on the Global AIDS Epidemic published
by UNAIDS (the Joint United Nations Programme on HIV/AIDS), the total number of people living with
HIV is 33.2 million globally with approximately 2.5 million newly infected in 2007 alone.
Approximately 25 million people infected with HIV have died since the start of the HIV pandemic in
1981. According to International AIDS Vaccine Initiative (IAVI) in a model developed with Advanced
Marketing Commitment (AMC) dated June 2005, the global market for a safe and effective AIDS vaccine
is estimated at approximately $4 billion.
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.
However, HIV is prone to genetic changes that can produce strains of HIV that are resistant to
currently approved RTIs and PIs. HIV that is resistant to one drug within a class can 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 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.
According to the IAVI, 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 organizations that
provide health care services, including hospitals, medical clinics, the military, prisons and
schools.
HIV/AIDS Vaccines Being Developed by the Company
Our vaccines were initially developed by Dr. Harriet Robinson at Emory University (Yerkes
Primate Center) in collaboration with researchers at the United States National Institutes of
Health (NIH) National Institute of Allergy and Infectious Disease (NIAID), and the United States
Centers for Disease Control (CDC), and are based on a two-component approach using recombinant DNA
(deoxyribonucleic acid) and MVA (Modified Vaccinia Ankara). Our focus is on developing vaccines
comprising the major HIV-1 subtypes (A, B and C). These vaccines could be used alone or as
combinations depending on a local infection. Subtype B is most common in North America, the
European Union, Japan and Australia and is our first priority.
When properly administered in series, our vaccines induce strong cellular and humoral immunity
against the two major HIV-1 proteins, Gag and Env. In non-human primate models vaccinations have
been done in non-infected rhesus macaques to prevent the development of disease should they become
infected (Preventative Vaccination) as well as in already infected rhesus macaques who are on drugs
to allow control of virus in the absence of drugs (Therapeutic Vaccination). Both applications have
met with success. The preventative immunizations have controlled both SHIV (chimeras of SIV and HIV
virus) and SIV infections in rhesus macaques. The therapeutic vaccine, which has only been tested
with SIV infections, is most effective when the vaccination regimen is initiated early after
infection before extensive destruction of the immune system by the infection.
The GeoVax vaccine elicits both protective antibodies and protective T-cells. The protective
antibodies do not neutralize (block infections) in cultured cells. However their avidity (tightness
of binding) to the envelope glycoproteins (Env) of HIV correlates with the blunting of infections
in challenge experiments in non-human primates. This likely reflects tightly bound antibody
initiating in vivo complement and Fc-receptor mediated mechanisms of virus and infected cell
killing. The vaccine also has the potential to elicit anti-viral IgA in rectal secretions. The
presence of anti-viral IgA in rectal secretions is associated with dampened infections in the
rhesus macaque model. Protective CD8 T-cells recognize and kill cells that become infected by virus
that has not been blocked by antibody. The presence of these cells is important to control virus
that has established a chronic infection.
Our method of stimulating high antibody and T-cell responses in the vaccinated person is to
combine DNA vaccine priming with a recombinant live virus vaccine boost. The boost we use is the
attenuated smallpox vaccine, Modified Vaccinia Ankara (MVA).
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This prime/boost combination elicits protective immune responses in preclinical monkey models
and holds high promise for eliciting responses that will protect humans against the development of
HIV/AIDS.
DNA as the Priming Vaccine
Priming with GeoVaxs HIV-1/DNA vaccine focuses the recipients immune response on the HIV-1
components (proteins) expressed by the DNA. The proteins expressed by the DNA pose no known risk
for infection because they comprise only part of the HIV virus. The DNA prime is followed by
injection of GeoVaxs HIV-1/MVA live virus vector booster which enhances the primed response in two
ways by expressing larger amounts of antigen than can be achieved with DNA alone, and by the
infection stimulating pro-inflammatory response that enhances immunity in the individual.
MVA Booster Vaccine
MVA was chosen as the poxvirus vector to boost immunity induced by the DNA priming vaccination
because of its safety features and because of the excellent protective responses that it has
stimulated in preclinical (non-human primate) models.
MVA was originally developed as a safe smallpox vaccine for use in immuno-compromised humans
by further attenuating the standard smallpox vaccine. During this attenuation (loss of disease
causing ability), MVA also lost essentially all of its ability to replicate in human cells. The
attenuation was accomplished by making over 500 passages of the virus in chicken embryos or chick
embryo fibroblasts (CEF). During passage, the virus underwent 6 large genomic deletions. These
deletions affected the ability of MVA to replicate and cause safety problems in humans, but did not
compromise the ability of MVA to grow on avian cells that are required for manufacturing the virus.
The effectiveness of MVA as a vaccine vector is also accounted for by its loss of immune
evasion genes during its passages in CEF cells. During the years of the dreaded human smallpox
epidemics these immune evasion genes assisted the spread of smallpox infections, even in the
presence of human immune responses.
MVA was safely administered to over 120,000 people in the 1970s to protect them against
smallpox. With the advent of bioterrorism, our choice of the MVA vector becomes even more
important, because of its potential for immunization for smallpox. GeoVax HIV vaccines may serve as
both an HIV and a smallpox vaccine.
GeoVaxs DNA and MVA vaccines express over 66% of the AIDS virus (HIV-1) protein components in
order to stimulate a broad anti-HIV immune response. The vaccines cannot cause AIDS because they do
not include the complete virus. We believe that the vaccines could provide multi-target protection
against the AIDS virus, thus largely limiting virus escape, large scale viral replication and the
onset of clinical signs of AIDS in the vaccinated individual.
Preclinical Studies
During the development of our vaccine, multiple efficacy trials were conducted in non-human
primates. These trials have shown the ability of the vaccine to provide protection in a variety of
non-human primate challenge models. The best protection has been achieved against chimeras of
simian and human immunodeficiency virus (SHIVs) where infections have been reduced to the level of
detection for the duration of the experiment (42 months). Less complete protection has been
achieved against simian immunodeficiency virus (SIVs) where protection has been associated with 10
to 100-fold drops in levels of virus in the blood. In both of these models, protection has been
associated with the avidity of the anti-Env antibody response and the presence of anti-viral IgA in
mucosal secretions. CD8 T-cells have been important for controlling the low levels of chronic
infection in the vaccinated and challenged animals.
Following these animal trials, our vaccines were approved for Phase 1 trials in humans by the
U.S. Food and Drug Administration (FDA). This preclinical work enabling development of the
clinical evaluation of our DNA and MVA vaccines was funded and supported by the NIAID. See
Government Regulation below for an explanation of how clinical trials are conducted.
Phase 1 Human Clinical Trials (Preventative Vaccine)
All of our human trials to date have been conducted by the HIV Vaccine Trials Network (HVTN),
a network that is funded and supported by the U.S. National Institutes of Health. The HVTN is the
largest worldwide clinical trials program for the development and testing of HIV/AIDS vaccines. The
vaccine that has been tested in these trials is a vaccine directed against the clade B infections
that are endemic in the developed world.
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Our first Phase 1 trial (HVTN 045) tested DNA-alone for its safety and immunogenicity. Our
second series of trials combined DNA priming with MVA boosting and tested (i) 1/10th dose as well
as (ii) anticipated full dose regimens which consisted of two DNA primes and two MVA boosts, (iii)
a full dose regimen of one DNA prime and two MVA boosts, and (iv) a full dose regimen of priming
and boosting with MVA. Based on the safety and the immunogenicity results in these trials, two full
dose DNA primes followed by two full dose MVA boosts are being taken forward into a Phase 2a trial.
Over 80 vaccine testing protocols have entered Phase 1 testing in the HVTN. Of these protocols,
only 5 (including GeoVaxs) have progressed to Phase 2 trials since 1992.
Phase 2 Human Clinical Trials (Preventative Vaccine)
Due to the promising positive human vaccine response data from our Phase 1 trials, the HVTN
proceeded with plans for the next phase of human clinical testing and patient enrollment commenced
in February 2009. This Phase 2a human clinical trial will enroll 225 participants, 150 of which
will receive vaccine and 75 of which will receive placebo. The goal of the trial is to obtain
additional safety and immunogenicity data from uses in low risk individuals to build a sufficient
foundation of data to progress to a Phase 2b proof of concept trial in high risk individuals. Trial
participants will first be administered a GeoVax HIV-1 DNA vaccine followed by a boost with
GeoVaxs HIV-1 MVA vaccine. The trial will be conducted in thirteen sites across North and South
America. We expect this trial may take 18-24 months to complete.
Planned Human Clinical Trials (Therapeutic Vaccine)
In July 2008, we reported summary data from a pilot study on therapeutic vaccination in simian
immunodeficiency virus (SIV) infected non-human primates with the SIV prototype of our HIV/AIDS
vaccine. In this small pilot study, conducted at Emory University (Yerkes Primate Center), two
non-human primates were infected with SIV. Data from the study revealed highly promising results
with the vaccine controlling the infection with reduction in viral levels of from 100 to 1000
times. The excellent control of the virus infection in the absence of drug treatment was associated
with the vaccine raising the types of CD4 and CD8 T-cells that are found in the rare individuals
who spontaneously control their HIV infections. Based on these results, we have begun planning for
a therapeutic trial in humans already infected with the HIV virus. The intent of therapeutic
vaccination will be to control HIV virus levels in infected individuals to very low levels thus
blocking the development of AIDS. We expect to initiate human clinical studies for a therapeutic
vaccine during the second half of 2009.
Support from the Federal Government
All of our Phase 1 human clinical trials (preventative vaccine) to date, and our recently
initiated Phase 2a trial, have been conducted by, and at the expense of, the HIV Vaccine Trials
Network (HVTN), a division of the National Institutes of Health-National Institute of Allergy &
Infectious Disease (NIH-NIAID). Our responsibility for these trials has been to provide sufficient
supplies of vaccine materials and technical expertise when necessary. The HVTN is also planning to
conduct our planned Phase 2 human clinical trials.
In September 2007, we were awarded an Integrated Preclinical/Clinical AIDS Vaccine Development
(IPCAVD) Grant by the NIH-NIAID to support our HIV/AIDS vaccine program. The project period for the
grant covers a five-year period that commenced October 2007, with an expected annual award of
between $3 and $4 million per year (approximately $17 million in the aggregate). The grant is
subject to annual renewal with the latest grant award covering the period from September 2008
through August 2009. Only meritorious HIV/AIDS prevention vaccine candidates are considered to
receive an IPCAVD award. Candidate companies are highly scrutinized and must supply substantial
positive AIDS vaccine data to support their application. IPCAVD grants are awarded on a competitive
basis and are designed to support later stage vaccine research, development and human trials. We
are utilizing this funding to further our HIV/AIDS vaccine development, optimization, production
and human clinical trial testing.
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 and 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.
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The steps required before a pharmaceutical agent may be marketed in the United States include:
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pre-clinical laboratory tests, in vivo pre-clinical studies and formulation studies; |
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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; |
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adequate and well-controlled human clinical trials to establish the safety and
efficacy of the product; |
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the submission of a New Drug Application to the FDA; and |
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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 FDAs 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 FDAs 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
vaccine is tested for safety (adverse side effects) and dosage tolerance. 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.
16
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
There currently is no FDA licensed and commercialized AIDS vaccine or competitive vaccine
available in the world market.
There are several small and large biopharmaceutical companies pursuing HIV/AIDS vaccine
research and development, including Merck, Novartis, Wyeth, Sanofi-Aventis, Glaxo-Smith Kline and
the United States National Institutes of Health (NIH) Vaccine Research Center (VRC). Other HIV/AIDS
vaccines are in varying stages of research, testing and clinical trials including those supported
by the International AIDS Vaccine Initiative (IAVI), the European Vaccine Initiative (EuroVac), and
the South African AIDS Vaccine Initiative (SAAVI), as well as others. To our knowledge, none of our
competitors products have, to date, demonstrated in large scale non-human primate trials the level
of protection and duration of protection for a SHIV challenge that have been elicited by GeoVaxs
vaccines. Furthermore, many competitor vaccine development programs require vaccine compositions
which are much more complicated than ours. For these reasons, we believe that it may be possible
for our vaccine to compete successfully in the marketplace if it is approved for sale.
Overall, the biopharmaceutical industry is competitive and subject to rapid and substantial
technological change. 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
have significantly greater research and development capabilities than we have, as well as
substantially more marketing, manufacturing, and financial 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.
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.
Intellectual Property
We will be able to protect our proprietary rights from unauthorized use by third parties only
to the extent that our proprietary rights are described by valid and enforceable patents or are
effectively maintained as trade secrets. Accordingly, we are pursuing and will continue to pursue
patent protection for our proprietary technologies developed through our collaboration between
Emory University, the NIH, and the CDC, or developed by us alone. Patent applications have been
filed with the United States Patent and Trademark Office and in specific international markets
(countries). Patent applications include provisions to cover our DNA and MVA based AIDS vaccines,
their genetic inserts expressing multiple HIV protein components, composition, structure, claim of
immunization against multiple subtypes of HIV, routes of administration, safety and other related
factors. Patent claims filed for our vaccines include provisions for protection against two
diseases: HIV/AIDS and smallpox.
We are the exclusive, worldwide licensee of a number of patents and patent applications (the
Emory Technology) owned, licensed or otherwise controlled by Emory University (Emory) for HIV
and smallpox vaccines pursuant to a License Agreement originally entered into on August 23, 2002
and restated on June 23, 2004 (the Emory License). Through the Emory License we are also a
non-exclusive licensee of patents owned by the NIH related to the ability of our MVA vector vaccine
as a vehicle to deliver HIV virus antigens, and also to induce an immune response in humans.
Currently, there are four issued patents and six pending patent applications in the United States
subject to the Emory License, as well as two issued patents and 26 pending patent applications in
other countries. The 4 issued patents expire in 2026. The Emory License expires on the expiration
date of the last to expire of the patents licensed thereunder including those that are issued on
patents pending; we will therefore not know the final termination date of the Emory License until
such patents are issued.
17
We may not use the Emory Technology for any purpose other than the purposes permitted by the
Emory License. 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 used in the production of our vaccines. 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.
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.
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.
We are not a party to any litigation, opposition, interference, or other potentially adverse
proceeding with regard to our patent positions. However, if we become involved in litigation,
interference proceedings, oppositions or other intellectual property proceedings, for example as a
result of an alleged infringement, or a third-party alleging an earlier date of invention, we may
have to spend significant amounts of money and time and, in the event of an adverse ruling, we
could be subject to liability for damages, invalidation of our intellectual property and injunctive
relief that could prevent us from using technologies or developing products, any of which could
have a significant adverse effect on our business financial condition and results of operation. In
addition, any claims relating to the infringement of third-party proprietary rights, or earlier
date of invention, even if not meritorious, could result in costly litigation, lengthy governmental
proceedings, divert managements attention and resources and require us to enter royalty or license
agreements which are not advantageous if available at all.
Manufacturing
We do not have the facilities or expertise to manufacture any of the clinical or commercial
supplies of any of our products, and we have relied on third party contract manufacturers to
produce our vaccine components used in our preclinical and clinical trials to date. 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 vaccines needed for research and clinical trials. We have entered into arrangements with
third party manufacturers for the supply of our DNA and MVA vaccines for use in our planned
clinical trials. These suppliers operate under current Good Manufacturing Practice and guidelines
established by the FDA and the European Medicines Agency. We anticipate that these suppliers will
be able to provide sufficient vaccine supplies to complete our currently planned clinical trials.
Various contractors are generally available in the United States and Europe for manufacture of
vaccines for clinical trial evaluation, however, it may be difficult to replace existing
contractors for certain manufacturing and testing activities and costs for contracted services may
increase substantially if we switch to other contractors.
18
In July 2008, we signed a letter of intent with Vivalis S.A., a French biopharmaceutical
company, for joint collaboration and license of Vivalis proprietary EBx ® technology.
The letter of intent contemplates development of a process using the EBx ® technology
to manufacture the MVA component of the GeoVax HIV-1 vaccine. Vivalis vaccine manufacturing
technology is based on a duck embryonic stem cell substrate platform, providing continuous growth
from a fully characterized frozen cell bank without necessitating fertilized embryo extraction and
processing, as with present chicken cell based technologies. Furthermore, the EB66 ®
cell line can be grown in suspension (without the cells attached to the surface of the growth
vessel) and can be scaled up for growth in giant bioreactors (a cutting edge industrial method) for
large scale production of the MVA viral vaccine. We expect the final agreement with Vivalis to be
executed during the third quarter of 2009. Successful development of a manufacturing process for
the MVA component of our vaccine using Vivalis technology would enhance our ability to manufacture
the vaccine in large, economical commercial quantities.
Research and Development
Our expenditures for research and development activities were approximately $3,741,000,
$1,757,000 and $666,000 during the years ended December 31, 2008, 2007 and 2006, respectively. 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. We have not yet formulated any plans for
marketing and sales of any vaccine candidate we may successfully develop. Compliance with
environmental protection laws and regulations has not had a material effect on our capital
expenditures, earnings or competitive position.
Properties
We lease approximately 3,000 square feet of 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 the lease.
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.
Employees
As of April 30, 2009, we had eleven employees. None of our employees are covered by collective
bargaining agreements and we believe that our employee relations are good.
Available Information
Our website address is www.geovax.com. We make available on this website under Investors
SEC Reports, free of charge, our proxy statements, annual reports on Form 10-K, quarterly reports
on Form 10-Q, current reports on Form 8-K, and amendments to those reports as soon as reasonably
practicable after we electronically file or furnish such materials to the U.S. Securities and
Exchange Commission (SEC). We also make available on this website under the heading Investors
Corporate Governance our Code of Ethics.
19
MARKET FOR REGISTRANTS COMMON EQUITY AND RELATED STOCKHOLDER MATTERS
Market Information
Our common stock is currently traded on the over-the-counter bulletin board market under the
symbol GOVX. 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 |
|
2009 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
First Quarter |
|
$ |
0.20 |
|
|
$ |
0.09 |
|
|
2008 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Fourth Quarter |
|
|
0.20 |
|
|
|
0.09 |
|
|
|
|
|
Third Quarter |
|
|
0.20 |
|
|
|
0.13 |
|
|
|
|
|
Second Quarter |
|
|
0.29 |
|
|
|
0.12 |
|
|
|
|
|
First Quarter |
|
|
0.19 |
|
|
|
0.11 |
|
|
2007 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Fourth Quarter |
|
|
0.36 |
|
|
|
0.16 |
|
|
|
|
|
Third Quarter |
|
|
0.42 |
|
|
|
0.25 |
|
|
|
|
|
Second Quarter |
|
|
0.38 |
|
|
|
0.22 |
|
|
|
|
|
First Quarter |
|
|
0.66 |
|
|
|
0.18 |
|
On June 9, 2009, the last reported sale price of our common stock on the over-the-counter
bulletin board was $0.26 per share.
Holders
On April 20, 2009, there were approximately 1,400 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.
20
SELECTED FINANCIAL DATA
The following selected financial data are derived from our audited consolidated financial
statements and interim unaudited consolidated financial statements for the periods and at the dates
indicated below. 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 the information contained below in Managements Discussion and Analysis of
Financial Condition and Results of Operations, and our consolidated financial statements and the
related notes, beginning on page F-1 of this prospectus.
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Three Months Ended |
|
|
|
|
March 31, |
|
Year Ended December 31, |
|
|
2009 |
|
2008 |
|
2008 |
|
2007 |
|
2006 |
|
2005 |
|
2004 |
Statement of
Operations Data: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total revenues
(grant income) |
|
$ |
710,155 |
|
|
$ |
599,991 |
|
|
$ |
2,910,170 |
|
|
$ |
237,004 |
|
|
$ |
852,905 |
|
|
$ |
670,467 |
|
|
$ |
714,852 |
|
Net loss |
|
|
(861,509 |
) |
|
|
(682,510 |
) |
|
|
(3,728,187 |
) |
|
|
(4,241,796 |
) |
|
|
(584,166 |
) |
|
|
(1,611,086 |
) |
|
|
(2,351,828 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Basic and diluted
net loss per common
share |
|
|
(0.00 |
) |
|
|
(0.00 |
) |
|
|
(0.01 |
) |
|
|
(0.01 |
) |
|
|
(0.00 |
) |
|
|
(0.01 |
) |
|
|
(0.01 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Three Months Ended |
|
|
|
|
March 31, |
|
As of December 31, |
|
|
2009 |
|
2008 |
|
2008 |
|
2007 |
|
2006 |
|
2005 |
|
2004 |
Balance Sheet Data: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total assets |
|
$ |
2,769,423 |
|
|
$ |
2,527,370 |
|
|
$ |
3,056,241 |
|
|
$ |
3,246,404 |
|
|
$ |
2,396,330 |
|
|
$ |
1,685,218 |
|
|
$ |
1,870,089 |
|
|
Redeemable
convertible
preferred stock |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
1,016,555 |
|
|
|
938,475 |
|
|
Total stockholders
equity (deficit) |
|
$ |
2,477,130 |
|
|
$ |
2,392,702 |
|
|
|
2,709,819 |
|
|
|
2,647,866 |
|
|
|
2,203,216 |
|
|
|
(500,583 |
) |
|
|
(389,497 |
) |
21
MANAGEMENTS 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 prospectus. This discussion contains forward-looking
statements that involve risks and uncertainties because they are based on current expectations and
relate to future events and our future financial performance. 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 prospectus.
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 HIV vaccine technology which was developed in collaboration
with the National Institutes of Health and the Centers for Disease Control and Prevention.
Our HIV vaccine candidates have successfully completed preclinical efficacy testing in
non-human primates and Phase 1 clinical testing trials in humans. A Phase 2a human clinical trial
for our preventative HIV vaccine candidate was initiated during the fourth quarter of 2008, and
patient enrollment commenced in February 2009. The costs of conducting our human clinical trials to
date have been borne by the HIV Vaccine Trials Network (HVTN), funded by the NIH, with GeoVax
incurring costs associated with manufacturing the clinical vaccine supplies and other study
support. HVTN will also bear the cost of conducting our Phase 2a human clinical study, but we
cannot predict the level of support we will receive from HVTN for any additional clinical studies.
Our operations are also partially supported by an Integrated Preclinical/Clinical AIDS Vaccine
Development (IPCAVD) Grant from the NIH. The project period for the grant covers a five year period
which commenced October 2007, with an expected annual award of between $3-4 million per year
(approximately $17 million in the aggregate). The grant is subject to annual renewal, with the
latest grant award covering the period from September 2008 through August 2009. We intend to pursue
additional grants from the federal government, however, as we progress to the later stages of our
vaccine development activities, government financial support may be more difficult to obtain, or
may not be available at all. It will, therefore, be necessary for us to look to other sources of
funding in order to finance our development activities.
We anticipate incurring additional losses for several years as we expand our drug development
and clinical programs and proceed into higher cost human clinical trials. Conducting clinical
trials for our vaccine candidates in development is a lengthy, time-consuming and expensive
process. We do not expect to generate product sales from our development efforts for several years.
If we are unable to successfully develop and market pharmaceutical products over the next several
years, our business, financial condition and results of operations will be adversely impacted.
Critical Accounting Policies and Estimates
Managements discussion and analysis of our financial condition and results of operations is
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 for the year ended December 31, 2008. We believe the following critical accounting
policies affect our more significant judgments and estimates used in the preparation of our
consolidated financial statements:
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.
22
Revenue Recognition. We recognize revenue in accordance with the SECs Staff Accounting
Bulletin No. 101, Revenue Recognition in Financial Statements, as amended by Staff Accounting
Bulletin No. 104, Revenue Recognition, (SAB 104). SAB 104 provides guidance in applying U.S.
generally accepted accounting principles to revenue recognition issues, and specifically addresses
revenue recognition for upfront, nonrefundable fees received in connection with research
collaboration agreements. Our revenue consists primarily of government grant revenue, which is
recorded as income as the related costs are incurred.
Stock-Based Compensation. Effective January 1, 2006, we adopted Financial Accounting Standards
Board (FASB) Statement of Financial Accounting Standards No. 123 (revised 2004), Share-Based
Payments (SFAS 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 123R replaces SFAS 123, Accounting for Stock-Based Compensation, and supersedes
Accounting Principles Board (APB) Opinion No. 25, Accounting for Stock Issued to Employees. We
adopted SFAS 123R using the prospective application method which requires us to apply the
provisions of SFAS 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 123R and recognized on a straight line basis over the
service periods of each award.
Liquidity and Capital Resources
At March 31, 2009, we had cash and cash equivalents of $1,970,971, as compared to $2,191,180
and $1,990,356 at December 31, 2008 and December 31, 2007, respectively. Working capital totaled
$2,237,473 at March 31, 2009, compared to $2,455,412 and $2,432,276 at December 31, 2008 and
December 31, 2007, respectively.
Sources and Uses of Cash. We are a development-stage company and do not have any products
approved for sale. 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 sources of
cash are from sales of our equity securities and from government grant funding.
Cash Flows from Operating Activities. Net cash used in operating activities was $460,209 and
$764,971 for the three month periods ended March 31, 2009 and 2008, respectively. Net cash used in
operating activities was $2,367,886, $3,265,743 and $1,327,941 for the years ended December 31,
2008, 2007 and 2006, respectively. Generally, the differences between years are 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.
In September 2007, the NIH awarded us an Integrated Preclinical/Clinical AIDS Vaccine
Development (IPCAVD) grant to support our HIV/AIDS vaccine program. The project period for the
grant, which is renewable annually, covers a five year period which commenced October 2007, with an
expected annual award of between $3and$4 million per year (approximately $17 million in the
aggregate). We are utilizing this funding to further our HIV/AIDS vaccine development,
optimization, and production for human clinical trial testing. The funding we receive pursuant to
this grant is recorded as revenue at the time the related expenditures are incurred, and thus
partially offsets our net losses.
Cash Flows from Investing Activities. Our investing activities have consisted predominantly of
capital expenditures. Capital expenditures for the three month periods ended March 31, 2009 and
2008 were $-0- and $2,238, respectively. Capital expenditures for the years ended December 31,
2008, 2007 and 2006, were $99,831, $-0-, and $69,466, respectively.
Cash Flows from Financing Activities. Net cash provided by financing activities was $240,000
and $897,450 for the three month periods ended March 31, 2009 and 2008, respectively. Net cash
provided by financing activities was $2,668,541, $3,167,950 and $2,212,849 for the years ended
December 31, 2008, 2007 and 2006, respectively. The cash generated by our financing activities
generally relates to the sale of our common stock to individual accredited investors and to Fusion
Capital, offset by costs associated with our financing arrangement with Fusion Capital (see below).
In May 2008, we signed the Purchase Agreement with Fusion Capital which provides for the sale
of up to $10 million of shares of our common stock. In connection with this agreement, we filed a
registration statement related to the transaction with the SEC covering the shares that have been
issued or may be issued to Fusion Capital under the Purchase Agreement. The SEC declared effective
the registration statement on July 1, 2008, and we now have the right until July 1, 2010 to sell
our shares of common stock to Fusion Capital from time to time in amounts ranging from $80,000 to
$1 million per purchase transaction, depending on certain conditions as set forth in the Purchase
Agreement. During 2008, we received $500,000 from the sale of 3,709,964 shares of our common stock
to Fusion Capital pursuant to this arrangement. From January 1 through June 9, 2009, we have
received $580,000 from the sale of 4,972,247 shares of our common stock to Fusion Capital.
23
We believe that our current working capital, combined with the proceeds from the IPCAVD grant
awarded annually from the NIH and our anticipated use of the Purchase Agreement with Fusion
Capital, will be sufficient to support our planned level of operations at least through March 31,
2010. The extent to which we rely on the Fusion Capital Purchase Agreement as a source of funding
will depend on a number of factors, including the prevailing market price of our common stock and
the extent to which we can secure working capital from other sources if we choose to seek such
other sources. Even if we are able to access the remainder of the full $10 million under the Fusion
Capital Purchase Agreement, we may still need additional capital to fully implement our business,
operating and development plans. Should the financing we require to sustain our working capital
needs be unavailable or prohibitively expensive when we require it, the consequences could be a
material adverse effect on our business, operating results, financial condition and prospects.
While we believe that we will be successful in obtaining the necessary financing to fund our
operations through the Fusion Capital Purchase Agreement or through other sources, there can be no
assurances that such additional funding will be available to us on reasonable terms or at all.
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 the sale of 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. Due to the existing uncertainty
in the capital and credit markets, and adverse regional and national economic conditions which may
persist or worsen, capital may not be available on terms acceptable to the Company 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.
We have no off-balance sheet arrangements that are likely or reasonably likely to have a
material effect on our financial condition or results of operations.
Contractual Obligations
As of March 31, 2009 and December 31, 2008, we had approximately $298,800 and $203,000,
respectively, of unrecorded contractual commitments associated with our vaccine manufacturing
activities, for services expected to be rendered to us during 2009. As of that date, we had no
other firm purchase obligations or commitments for capital expenditures, 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 senior management team, each of 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.
In July 2008, we signed a non-binding letter of intent for a joint collaboration and
commercial license for the use of vaccine manufacturing technology owned by Vivalis S.A., a French
biopharmaceutical company. Subsequent to the signing of the letter of intent, we paid a signing fee
of approximately $241,000 to Vivalis, and upon execution of the final license agreement (expected
to occur during the third quarter of 2009), we will incur a commitment of approximately $900,000 as
our contribution to the joint development effort in 2009 and early 2010.
As the development milestone fees are denominated in Euros, this estimate of our financial
commitment is based on current exchange rates; the actual amounts will be greater or lesser,
depending on the actual exchange rates at the time of each milestone achievement.
Net Operating Loss Carryforward
At December 31, 2008, we had consolidated net operating loss carryforwards for income tax
purposes of approximately $70 million, which will expire in 2010 through 2028 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 $355,000 available to reduce income taxes, if any, which will expire in 2022 through
2027 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.
24
Results of Operations Three month periods ended March 31, 2009 and 2008
Net Loss
We recorded a net loss of $861,509 for the three months ended March 31, 2009 as compared to
$682,510 for the three months ended March 31, 2008. Our operating results will typically fluctuate
due to the timing of activities and related costs associated with our vaccine research and
development activities and our general and administrative costs, as described in more detail below.
Grant Revenue
We recorded grant revenues of $710,155 and $599,991 during the three month periods ended March
31, 2009 and 2008, respectively. During 2007, we were awarded an Integrated Preclinical/Clinical
AIDS Vaccine Development (IPCAVD) grant by the NIH to support our HIV/AIDS vaccine program. The
project period for the grant, which is renewable annually, covers a five year period which
commenced October 2007, with an expected annual award of between $3 to $4 million per year
(approximately $17 million in the aggregate). We are utilizing this funding to further our HIV/AIDS
vaccine development, optimization and production. The grant is subject to annual renewal, with the
latest grant award covering the period from September 2008 through August 2009. As of March 31,
2009, there is approximately $2.4 million remaining from the current grant years award. Assuming
that the remaining budgeted amounts under the grant are awarded annually to the Company, there is
an additional $11.1 million available through the grant for the remainder of the original five year
project period (ending August 31, 2012).
Research and Development
Our research and development expenses were $857,236 and $603,478 during the three month
periods ended March 31, 2009 and 2008, respectively. 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, and due to fluctuations in the timing of other
external expenditures related to the NIH grant. Research and development expense includes
stock-based compensation expense of $85,439 and $37,917 and for the 2009 and 2008 periods
respectively (see discussion below). Our recently initiated Phase 2a clinical trial will be
conducted and funded by the HVTN, but we are responsible for the manufacture of vaccine product to
be used in the trial. We cannot predict the level of support we may receive from HVTN or other
federal agencies (or divisions thereof) for our future clinical trials. We expect that our research
and development costs will continue to increase in 2009 and beyond as we progress through the human
clinical trial process leading up to possible product approval by the FDA.
In July 2008, we signed a letter of intent with Vivalis S.A., a French biopharmaceutical
company, for joint collaboration and license of Vivalis proprietary EBx® technology. The letter of
intent contemplates development of a process using the EBx® technology to manufacture the MVA
component of the GeoVax HIV-1 vaccine. Vivalis vaccine manufacturing technology is based on a duck
embryonic stem cell substrate platform, providing continuous growth from a fully characterized
frozen cell bank without necessitating fertilized embryo extraction and processing, as with present
chicken cell based technologies. Furthermore, the EB66® cell line can be grown in suspension
(without the cells attached to the surface of the growth vessel) and can be scaled up for growth in
giant bioreactors (a cutting edge industrial method) for large scale production of the MVA viral
vaccine. We expect the final agreement with Vivalis to be executed during the third quarter of
2009. After execution of this agreement, we expect to incur between $1.5 and $2.0 million in costs
associated with development of this vaccine manufacturing technology during 2009 and early 2010.
General and Administrative Expense
During the three month period ended March 31, 2009, we incurred general and administrative
costs of $723,815, as compared to $705,642 during the three month period ended March 31, 2008.
General and administrative costs include officers salaries, legal and accounting costs, patent
costs, amortization expense associated with intangible assets, and other general corporate
expenses. General and administrative expense also includes stock-based compensation expense of
$303,381 and $360,679 and for the 2009 and 2008 periods respectively (see discussion below). We
expect that our general and administrative costs will increase in the future in support of expanded
research and development activities.
Stock-Based Compensation Expense
During the three month periods ended March 31, 2009 and 2008, we recorded total stock-based
compensation expense of $388,820 and $398,596, respectively, which is included in research and
development expense, or general and administrative expense according to the classification of cash
compensation paid to our employees, directors or consultants to whom the stock compensation awards
were granted. Stock-based compensation expense is calculated and recorded in accordance with the
provisions of SFAS 123R. We adopted SFAS 123R using the prospective application method which
requires us to apply its provisions prospectively to new awards and to awards modified, repurchased
or cancelled after December 31, 2005. Awards granted after December 31, 2005 are
25
valued at fair value in accordance with the provisions of SFAS 123R and recognized on a
straight line basis over the service periods of each award. As of March 31, 2009, there was
$1,461,503 of unrecognized compensation expense related to stock-based compensation arrangements.
Other Income
Interest income for the three month periods ended March 31, 2009 and 2008 was $9,387 and
$26,619, respectively. The variances between periods are primarily attributable to the incremental
cash balances available for investment during each respective period as well as the prevailing
interest rates available from our financial institution.
Results of Operations Years ended December 31, 2008, 2007 and 2006
Net Loss
We recorded net losses of $3,728,187, $4,241,796 and $584,166 for the years ended December 31,
2008, 2007 and 2006, respectively.
Grant Revenue
We recorded grant revenues of $2,910,170 in 2008, $237,004 in 2007 and $852,905 in 2006. Grant
revenue reported during 2006 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 University; the activities associated with these grants were completed during 2006. As
of December 31, 2008, there was approximately $3 million remaining under the current years award
under the IPCAVD grant by the NIH and carryovers from the prior year award.
Research and Development
Our research and development expenses were $3,741,489 in 2008, $1,757,125 in 2007 and $665,863
in 2006. Research and development expenses vary considerably on a period-to-period basis, primarily
depending on our need for vaccine manufacturing and testing of manufactured vaccine by third
parties. Research and development expense includes stock-based compensation expense of $494,041,
$284,113 and $-0- for 2008, 2007 and 2006, respectively (see discussion below). Research and
development costs increased during the 2007 and 2008 periods as a direct result of spending
associated with the NIH grant discussed above, and due to costs associated with our vaccine
manufacturing activities in preparation for commencement of Phase 2 clinical testing, as well as
the addition of new scientific personnel.
In July 2008, we signed a letter of intent with Vivalis S.A., a French biopharmaceutical
company, for joint collaboration and license of Vivalis proprietary EBx ® technology.
The letter of intent contemplates development of a process using the EBx ® technology
to manufacture the MVA component of the GeoVax HIV-1 vaccine. Vivalis vaccine manufacturing
technology is based on a duck embryonic stem cell substrate platform, providing continuous growth
from a fully characterized frozen cell bank without necessitating fertilized embryo extraction and
processing, as with present chicken cell based technologies. Furthermore, the EB66 ®
cell line can be grown in suspension (without the cells attached to the surface of the growth
vessel) and can be scaled up for growth in giant bioreactors (a cutting edge industrial method) for
large scale production of the MVA viral vaccine. We expect the final agreement with Vivalis to be
executed during the third quarter of 2009. Subsequent to execution of this agreement, we expect to
incur substantial costs associated with development of this vaccine manufacturing technology, with
preliminary cost estimates ranging from $1.5 to $2.0 million during 2009 and early 2010.
General and Administrative Expense
Our general and administrative expenses were $2,970,068 in 2008, $2,784,182 in 2007 and
$843,335 in 2006. General and administrative costs substantially increased during the three-year
period ending December 31, 2007 primarily as a result of the Company becoming a publicly-traded
entity subsequent to the merger of GeoVax Labs, Inc and GeoVax, Inc. in September 2006. These
higher costs include, among other things, the costs of an expanded management team (including the
engagement of our Chief Financial Officer in October 2006 and our Senior Vice President in January
2007), a newly instituted investor relations program, costs associated with an expanded Board of
Directors, costs associated with our efforts to comply with the Sarbanes-Oxley Act of 2002, and
increased legal and accounting fees associated with compliance with securities laws. General and
administrative expense includes stock-based compensation expense of $1,525,008, $1,234,380 and $-0-
for 2008, 2007 and 2006, respectively (see discussion below).
Stock-Based Compensation Expense
During 2008, we recorded total stock-based compensation expense of $2,019,049, which was
allocated to research and development expense ($494,041), or general and administrative expense
($1,525,008) according to the classification of cash compensation paid to the employee, consultant
or director to whom the stock compensation was granted. During 2007, we recorded
26
total stock-based compensation expense of $1,518,496, of which $284,113 was allocated to
research and development expense and $1,234,380 was allocated to general and administrative
expense. No stock-based compensation expense was recorded during 2006. We did not grant or modify
any share-based compensation during 2006, thus no expense was recorded during for that year.
Other Income
Interest income was $73,200 in 2008, $62,507 in 2007 and $72,127 in 2006. The variances
between years are primarily attributable to the cash available for investment, which totaled
$2,191,180 at December 31, 2008, $1,990,356 at December 31, 2007 and $2,088,149 at December 31,
2006.
Impact of Inflation
For the three-year period ending December 31, 2008, 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.
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.
27
DIRECTORS AND EXECUTIVE OFFICERS
The following table sets forth certain information with respect to our directors and executive
officers.
|
|
|
|
|
|
|
Name |
|
Age |
|
Current Position |
Donald G. Hildebrand
|
|
|
68 |
|
|
Chairman of the Board of Directors |
Andrew J. Kandalepas
|
|
|
57 |
|
|
Senior Vice President and Director |
Dean G. Kollintzas*
|
|
|
36 |
|
|
Director |
Robert T. McNally, Ph.D.
|
|
|
61 |
|
|
President and Chief Executive Officer, Director |
Mark W. Reynolds
|
|
|
47 |
|
|
Chief Financial Officer and Corporate Secretary |
Harriet L. Robinson, Ph.D.
|
|
|
71 |
|
|
Senior Vice President, Research & Development, Director |
John N. Spencer, Jr.*
|
|
|
68 |
|
|
Director |
Peter M. Tsolinas*
|
|
|
73 |
|
|
Director |
|
|
|
* |
|
Member of the Audit Committee and the Compensation Committee of the Board of Directors. |
Donald G. Hildebrand. Mr. Hildebrand joined the Board of Directors as Chairman and became our
President and Chief Executive Officer upon consummation of the merger with GeoVax, Inc. in
September 2006. Effective April 1, 2008, upon the appointment of Dr. Robert McNally as our
President and Chief Executive Officer, Mr. Hildebrand executed a consulting agreement with the
Company and remained as Chairman of the Board. Mr. Hildebrand is a founder of GeoVax, Inc., our
wholly-owned subsidiary, and has served as a member of its Board of Directors since June 2001.
Prior to founding GeoVax, Mr. Hildebrand was North American President and Chief Executive Officer
of Rhone Merieux, Inc., a subsidiary of Rhone Merieux, S.A., a world leader in the
biopharmaceutical and animal health industries. In 1997, Mr. Hildebrand also became Global Vice
President of Merial Limited, a position that he held until retiring in 2000. Mr. Hildebrand
received his BS in microbiology from the University of Wisconsin.
Andrew J. Kandalepas. Mr. Kandalepas was Chairman of the Board, President and Chief Executive
Officer of Dauphin Technology from 1995 until the merger with GeoVax, Inc. in September 2006, at
which time he assumed the position of Senior Vice President and remained a director of the Company.
Mr. Kandalepas has a varied 30-plus year career as an entrepreneur and executive manager. Mr.
Kandalepas earned his Electronics Engineering Degree from DeVry Institute of Technology.
Dean G. Kollintzas. Mr. Kollintzas joined the Board of Directors upon consummation of the
merger with GeoVax, Inc. in September 2006. Since 2001, Mr. Kollintzas has been an Intellectual
Property attorney specializing in biotechnology and pharmaceutical licensing, FDA regulation, and
corporate/international transactions. Mr. Kollintzas received a Microbiology degree from the
University of Illinois and a J.D. from Franklin Pierce Law Center. He is a member of the Wisconsin
and American Bar Associations.
Robert T. McNally, Ph.D. Dr. McNally joined the Board of Directors in December 2006 and was
appointed as our President and Chief Executive Officer effective April 1, 2008. From 2000 to March
2008, Dr. McNally served as Chief Executive Officer of Cell Dynamics LLC, a cGMP laboratory
services company. Previously, Dr. McNally was Senior Vice President of Clinical Research for
CryoLife, Inc., a pioneering company in transplantable human tissues. Dr. McNally is a Fellow of
the American Institute for Medical and Biological Engineering, serves on the advisory boards of the
Petit Institute for Bioengineering and Dupree College of Management at the Georgia Institute of
Technology, and is a past Chairman of Georgia Bio, a trade association. Dr. McNally graduated with
a Ph.D. in Biomedical Engineering from the University of Pennsylvania.
Mark W. Reynolds, CPA. Mr. Reynolds joined the Company in October 2006 as Chief Financial
Officer and Corporate Secretary. From 2003 to 2006, before being named Chief Financial Officer of
GeoVax Labs, Inc., Mr. Reynolds provided financial and accounting services to GeoVax, Inc. as an
independent contractor. From 2004 to the present, Mr. Reynolds has served as Chief Financial
Officer for HealthWatchSystems, Inc. a privately-held company in the consumer healthcare industry,
a position which he continues to hold. From 2004 to 2006, he served as Chief Financial Officer for
Duska Therapeutics, Inc., a publicly-held biotechnology company. From 1988 to 2002, Mr. Reynolds
was first Controller and later Chief Financial Officer and Corporate Secretary for CytRx
Corporation, a publicly-held biopharmaceutical company. Mr. Reynolds began his career as an auditor
with Arthur Andersen & Co. from 1985 to 1988. He is a certified public accountant and earned a
Masters of Accountancy degree from the University of Georgia.
28
Harriet Latham Robinson, Ph.D. Dr. Robinson joined the Company as Senior Vice President,
Research and Development on a part-time basis in November 2007 and on a full-time basis in February
2008, and was elected to the Board of Directors in June 2008. She is a co-founder of GeoVax, Inc.
and has served as Chief of its Scientific Advisory Board since formation of the company in 2001.
From 1999 to February 2008, Dr. Robinson served as the Asa Griggs Candler Professor of Microbiology
and Immunology at Emory University in Atlanta, Georgia, and from 1998 to February 2008 as Chief,
Division of Microbiology and Immunology, Yerkes National Primate Center and Professor at the Emory
University School of Medicine. She was Professor, Dept. of Microbiology & Immunology at the
University of Massachusetts Medical Center from 1988 to 1997 and Staff, then Senior, then Principal
Scientist at the University of Massachusetts Worcester Foundation for Experimental Biology from
1977 to 1987. She was also a National Science Foundation Postdoctoral Fellow at the Virus
Laboratory, University of California, Berkeley, in Berkeley, California from 1965 to 1967. Dr.
Robinson has a B.A degree from Swarthmore College and M.S. and Ph.D. degrees from the Massachusetts
Institute of Technology.
John N. (Jack) Spencer, Jr., CPA. Mr. Spencer joined the Board of Directors upon consummation
of the merger with GeoVax, Inc. in September 2006. Mr. Spencer is a certified public accountant and
was a partner of Ernst & Young where he spent more than 38 years until he retired in 2000. Mr.
Spencer serves as a director of a number of privately held companies. He also serves as a
consultant to various companies primarily relating to financial accounting and reporting matters.
Mr. Spencer received a BS degree from Syracuse University, and he earned an MBA degree from Babson
College. He also attended the Harvard Business School Advanced Management Program.
Peter M. Tsolinas. Mr. Tsolinas joined the Board of Directors in August 2008. In 1981, Mr.
Tsolinas founded TMA Group Development Corp., a Chicago based real estate, architectural and
development firm, and he currently serves as its Chairman and CEO, a position he has held since its
formation. Mr. Tsolinas has a varied career of more than 45 years as an architect and real estate
developer. Mr. Tsolinas attended the University of Illinois where he received a Bachelor of
Architecture degree.
Director Independence
The Board of Directors has determined that Dean Kollintzas, John Spencer and Peter Tsolinas
are the members of our Board of Directors who are independent, as that term is defined by Section
301(3)(B) of the Sarbanes-Oxley Act of 2002. The Board of Directors has also determined that these
three individuals meet the definition of independent set forth in NASDAQ Rule 5605 (formerly Rule
4200), which is part of its listing standards. As independent directors, Mr. Kollintzas, Mr.
Spencer and Mr. Tsolinas serve as the members of our Audit and Compensation Committees. Prior to
his appointment as our President and Chief Executive Officer in April 2008, Dr. McNally was also an
independent director and served as a member of our Audit and Compensation Committees.
COMPENSATION DISCUSSION AND ANALYSIS
Executive Summary
In the paragraphs that follow, the Compensation Committee provides an overview and analysis of
our compensation program and policies, the material compensation decisions made under those
programs and policies with respect to our executive officers, and the material factors considered
in making those decisions.
The Compensation Committee reviews, analyzes and approves the compensation of our senior
executive officers, including the Named Executive Officers listed in the tables set forth
following this Compensation Discussion and Analysis. The Named Executive Officers for 2008 include
the two individuals who held the office of chief executive officer, our chief financial officer,
and the two other executive officers whose total compensation for 2008 exceeded $100,000,
calculated in accordance with the rules and regulations of the SEC. Our Named Executive Officers
for 2008 are:
|
|
|
Robert McNally, President and Chief Executive Officer |
|
|
|
|
Donald Hildebrand, former President and Chief Executive Officer |
|
|
|
|
Andrew Kandalepas, Senior Vice-President |
|
|
|
|
Mark Reynolds, Chief Financial Officer |
|
|
|
|
Harriet Robinson, Senior Vice-President, Research and Development |
29
The tables that follow this Compensation Discussion and Analysis contain specific data about
the compensation earned or paid in 2008 to the Named Executive Officers. The discussion below is
intended to help you understand the detailed information provided in the compensation tables and
put that information into context within our overall compensation program.
Objectives of Our Compensation Program
In general, we operate in a marketplace where competition for talented executives is
significant. The biopharmaceutical industry is highly competitive and includes companies with far
greater resources than ours. We are engaged in the long-term development of drug candidates,
without the benefit of significant current revenues, and therefore our operations involve a high
degree of risk and uncertainty. This level of risk and uncertainty may make it difficult to retain
talented executives. Nevertheless, continuity of personnel across multi-disciplinary functions is a
critical success factor to our business. Furthermore, since we have relatively few employees, each
must perform a broad scope of functions, and there is very little redundancy in skills.
The objectives of our compensation program for our executive officers and other employees are
to provide competitive cash compensation, health, and retirement benefits as well as long-term
equity incentives that offer significant reward potential for the risks assumed and for each
individuals contribution to our long-term performance. Individual performance is measured
subjectively against overall corporate goals, scientific innovation, regulatory compliance, new
business development, employee development, and other values designed to build a culture of high
performance. These policies and practices are based on the principle that total compensation should
serve to attract and retain those executives and employees critical to our overall success and are
designed to reward executives for their contributions toward business performance that enhances
stockholder value.
Role of the Compensation Committee
Our Compensation Committee assists our Board in discharging its responsibilities relating to
compensation of our executive officers. As such, the Compensation Committee has responsibility over
matters relating to the fair and competitive compensation of our executives, employees and
directors (only non-employee directors are compensated as such) as well as matters relating to all
other benefit plans. Each of the members of our Compensation Committee is independent in accordance
with the criteria of independence set forth in Section 301(3)(B) of the Sarbanes-Oxley Act of 2002.
We believe that their independence from management allows the Compensation Committee members to
provide unbiased consideration of various elements that could be included in an executive
compensation program and apply independent judgment about which elements and designs best achieve
our compensation objectives. With regard to executive compensation, the Compensation Committee is
charged specifically with annually reviewing and determining the compensation of our Chief
Executive Officer. With regard to our other executive officers, the Compensation Committee reviews,
at least annually, recommendations from our Chief Executive Officer and acts on his recommendations
as appropriate. The Compensation Committee also approves a pool of stock options to be granted as
recommended by the Chief Executive Officer to our employees (including other executive officers)
and the Board of Directors approves the grant of such options.
Elements of Compensation
To achieve the objectives described above, the three primary compensation elements used for
executive officers are base salary, cash bonus, and stock option awards. We believe that these
three elements are the most effective combination in motivating and retaining our executive
officers at this stage in our development.
Base Salary. Our philosophy is to maintain executive base salary at a competitive level
sufficient to recruit and retain individuals possessing the skills and capabilities necessary to
achieve our goals over the long term. Base salaries provide our executive officers with a degree of
financial certainty and stability and also reward individual achievements and contributions. Each
individuals base salary is determined after considering a variety of factors including prospective
value to us, the knowledge, experience, and accomplishments of the individual and the individuals
level of responsibility.
Cash Bonus. Annual cash incentive awards motivate our executives to contribute toward the
achievement of corporate goals and objectives. Generally, every staff member is eligible to earn an
annual cash incentive award, promoting alignment and pay-for-performance at all levels of the
organization. The Company currently does not have a formalized cash incentive award plan, and
awards are based on the subjective recommendation of the President & CEO and on the Committees
judgment.
Stock Option Awards. Stock option awards are a fundamental element in our executive
compensation program because they emphasize our long-term performance, as measured by creation of
stockholder value, and align the interests of our stockholders and management. In addition, the
Compensation Committee believes they are crucial to a competitive compensation program for
executive officers, and they act as a powerful retention tool. In our current pre-commercial state,
we view the Company as still facing a significant level of risk, but with the potential for a high
upside, and therefore we believe that stock incentive awards are appropriate for executive
officers. These awards are provided through initial grants at or near the date of hire and through
subsequent periodic grants. The initial grant is designed for the level of the job that the
executive holds and is designed to motivate the officer to make the
30
kind of decisions and implement strategies and programs that will contribute to an increase in
our stock price over time. Periodic additional stock option awards may be granted to reflect the
executives ongoing contributions to the Company, to create an incentive to remain at the Company,
and to provide a long-term incentive to achieve or exceed our corporate goals and objectives . The
Company currently does not have a formula for determining stock option awards; and awards are
generally based on the subjective recommendation of the President & CEO and on the Committees
judgment.
Timing of Annual Awards
In order to assess the performance of a full calendar year, annual cash bonus and stock option
awards are generally determined in December of the each year. We do not currently have any program,
plan or practice in place to time stock option grants to our executives or other employees in
coordination with the release of material non-public information.
Accounting and Tax Considerations
The accounting and tax treatment of compensation generally has not been a factor in
determining the amounts of compensation for the Companys executive officers.
Section 162(m) of the Internal Revenue Code of 1986, as amended, limits tax deductions of
public companies on compensation paid to certain executive officers in excess of $1 million. The
Compensation Committee considers the impact of Section 162(m) on its compensation decisions, but
has no formal policy to structure executive compensation so that it complies with the requirements
of Section 162(m). In general, stock options granted under the Companys 2006 Equity Incentive Plan
(Plan) are intended to qualify under and comply with the performance based compensation
exemption provided under Section 162(m) thus excluding from the Section 162(m) compensation
limitation any income recognized by executives at the time of exercise of such stock options.
Statement of Financial Accounting Standards No. 123(R), Share-Based Payment (FAS 123(R))
requires us to recognize an expense for the fair value of equity-based compensation awards. Grants
of stock options under our equity incentive award plans are accounted for under FAS 123(R). The
Compensation Committee considers the accounting implications of significant compensation decisions,
especially in connection with decisions that relate to our equity incentive award plans, but has no
formal policy to structure executive compensation to align accounting expenses of our equity awards
with our overall executive compensation philosophy and objectives.
Setting Executive Compensation
Historically, we have not used a quantitative method or mathematical formulas exclusively in
setting any element of executive compensation. We use discretion, guided in large part by the
concept of pay for performance, and we consider all elements of an executives compensation package
when setting each portion of compensation. There is no pre-established policy or target for the
allocation between cash and equity incentive compensation.
When determining compensation for a new executive officer, factors taken into consideration
are the individuals skills, background and experience, the individuals past and potential future
impact on our short- and long-term success, and competitive information from industry-specific
sources, and possibly from other prospective candidates interviewed during the recruitment process.
We will generally make a grant of stock options when an executive officer joins us. Options are
granted at no less than 100% of the fair market value on the date of grant. In determining the size
of a stock option grant to an executive officer, we consider company performance, competitive data,
and the individuals scope of responsibility and continuing performance. Most importantly, since
the stock option grant is meant to be a retention tool, we consider the importance to stockholders
of that persons continued service. Stock option grants to executives will generally vest over a
period of three years.
The Compensation Committee annually reviews and determines the compensation for our Chief
Executive Officer. Each year recommendations for the compensation for other executive officers
(other than himself) are prepared by the Chief Executive Officer and are reviewed with the
Committee and modified where appropriate.
As part of its executive compensation review conducted annually in December, the Committee
reviews a tally sheet setting forth all components of total compensation to our CEO, our Named
Executive Officers and all other employees. The tally sheet includes current and proposed base
salary, proposed annual cash incentive awards and historical as well as proposed stock option
awards. These tools are employed by the Committee as a useful check on total compensation and are
considered important because the Committees decisions are usually made on a program-by-program
basis and in the context of the program being considered. These tools show the effect of
compensation decisions made over time on the total annual compensation to a Named Executive Officer
and allow the Committee to review historical amounts for comparative purposes.
31
2008 Executive Compensation
Using its judgment of the skills, experience, responsibilities, achievements and historical
compensation of each of the Named Executive Officers, the Committee established their salaries for
2008 at its meeting in December 2007. At its meeting in December 2008, the Committee considered the
same factors in determining the award of cash bonuses, stock option grants and salary increases for
2009.
In its deliberations on executive compensation at its meeting in December 2008, the Committee
considered and accepted the recommendation from Dr. McNally that none of the Named Executive
Officers receive a cash bonus for 2008 and that no salary increases would be effective for 2009,
except as related to Mr. Reynolds with respect to a proportionate increase relative to his time
commitment to the business of the Company. Although the Committee believes the Company made
substantial progress in several areas during 2008, and that each of the Named Executive Officers
contributed significantly to this progress, the Committee also gave consideration to the current
economic environment with regard to the Companys ability to efficiently raise capital, and
therefore to the Companys need to conserve its cash resources. This decision by the Committee did
not impact the awarding of cash bonuses and salary increases to the Companys non-executive
employees. Other considerations specific to each of the individual Named Executive Officers are
described below.
Donald Hildebrand. Mr. Hildebrand retired as our President and Chief Executive Officer
effective April 1, 2008, and was succeeded by Robert T. McNally, Ph.D. In order to assist with the
transition of certain duties to Dr. McNally, Mr. Hildebrand entered into a Consulting Agreement
with us on March 20, 2008. Mr. Hildebrand also remained as Chairman of the Board. Mr. Hildebrand
did not receive any cash bonuses or stock option grants during 2008. See Summary Compensation
Table and Certain Relationships and Related Party Transactions for additional information on the
Consulting Agreement with Mr. Hildebrand. During 2008, the Company extended the exercise period of
8,895,630 stock options held by Mr. Hildebrand see Stock Option Extensions below.
Robert McNally. On March 20, 2008, we entered into an Employment Agreement with Dr. McNally to
become our new President and Chief Executive Officer effective April 1, 2008 upon Mr. Hildebrands
retirement. Dr. McNallys annual compensation was initially set at $200,000 determined, in part, by
the transitional role Mr. Hildebrand provided through his consulting arrangement. On June 17, 2008,
at its first meeting after Dr. McNallys taking office, and upon his re-appointment to the office
subsequent to the Annual Meeting of Stockholders, the Compensation Committee increased Dr.
McNallys annual salary to $250,000 and granted a stock option contract to him for 2,400,000 shares
at an exercise price of $0.17 per share. These changes were based on the Committees subjective
judgment of the value being provided by Dr. McNally and to provide an appropriate long-term
incentive for him. In determining Dr. McNallys compensation adjustments, the Compensation
Committee considered the relative level of other Company executives pay, and the amount of
outstanding stock options previously awarded to Dr. McNally in consideration for service as an
outside Board member prior to his employment by the Company as President and Chief Executive
Officer. In December 2008, the Board awarded Dr. McNally an additional stock option grant for
500,000 shares at an exercise price of $0.11 per share. Dr. McNally received no cash bonuses during
2008.
Andrew Kandalepas. Mr. Kandalepas serves as our Senior Vice President pursuant to an
employment agreement executed in February 2007. During 2008 he received a base salary of $225,000.
In December 2008, the Board awarded Mr. Kandalepas a stock option grant for 500,000 shares at an
exercise price of $0.11 per share. Mr. Kandalepas received no cash bonuses during 2008.
Mark Reynolds. Mr. Reynolds serves as our Chief Financial Officer pursuant to an employment
agreement executed in February, 2008. Pursuant to this agreement, Mr. Reynolds provides services to
the Company on a part-time basis and was paid a salary of $115,000 during 2008. Prior to entering
in the employment agreement, Mr. Reynolds was paid a monthly retainer of $750 plus a fee of $145
per hour. In December 2008, the Board awarded Mr. Reynolds a stock option grant for 500,000 shares
at an exercise price of $0.11 per share. Mr. Reynolds received no cash bonuses during 2008.
Harriet Robinson. Dr. Robinson serves as our Senior Vice President Research and Development
pursuant to an employment agreement executed in November, 2008. Pursuant to this agreement, Dr.
Robinson is paid an annual salary of $250,000. In December 2008, the Board awarded Dr. Robinson a
stock option grant for 500,000 shares at an exercise price of $0.11 per share. Dr. Robinson
received no cash bonuses during 2008. During 2008, the Company extended the exercise period of
8,895,630 stock options held by Dr. Robinson see Stock Option Extensions below.
Stock Option Extensions. On June 17, 2008, the Company extended the exercise period of stock
options granted in prior years to Mr. Hildebrand and Dr. Robinson. These stock options were
originally granted with an exercise period of 5-7 years and were to expire beginning in 2009. The
extensions were made to adjust the exercise period to 10 years from the original grant date. The
extensions did not affect the vesting schedule of the grants; all were originally granted with a
3-year vesting schedule and were fully vested at the time of the extensions. The Committees
decision to grant these extensions was based primarily on two factors:
32
|
|
|
The Companys current practice is to grant employee stock options with a 10 year
exercise period; the terms of the affected grants were inconsistent with current
practice. |
|
|
|
|
The imminent expiration dates, together with the beneficial exercise prices in
comparison to the prevailing market price of the Companys stock may have created
pressure for the individual to exercise the stock option prematurely and to sell the
underlying shares in a manner that may be inconsistent with the interests of the Company
and its stockholders. |
The Committee considered the impact of these extensions on all affected employees and gave no
preferential treatment or consideration to the Companys executive officers. In addition to Mr.
Hildebrand and Dr. Robinson, two other non-executive employees were also granted extensions.
Benefits Provided to Executive Officers
We provide our executive officers with certain benefits that the Compensation Committee
believes are reasonable and consistent with our overall compensation program. The Compensation
Committee will periodically review the levels of benefits provided to our executive officers.
Prior to his retirement effective April 1, 2008, Mr. Hildebrand received reimbursement of
periodic commuting expenses and temporary living expenses for travel between our offices in
Atlanta, Georgia and Mr. Hildebrands home in Athens, Georgia. Mr. Hildebrand is reimbursed for
medical and dental insurance costs per his consulting agreement.
Dr. McNally, Mr. Kandalepas, Mr. Reynolds and Dr. Robinson are eligible for health insurance
and 401(k) benefits at the same level and subject to the same conditions as provided to all other
employees. The amounts shown in the Summary Compensation Table under the heading All Other
Compensation represent the value of the Companys matching contributions to the executive
officers 401(k) accounts. Executive officers did not receive any other perquisites or other
personal benefits or property from the Company or any other source.
33
SUMMARY COMPENSATION TABLE
The following table sets forth information concerning the compensation earned during the
fiscal years ended December 31, 2008, 2007 and 2006 by each person who served as our Chief
Executive Officer, and by our Chief Financial Officer and Senior Vice Presidents (collectively, our
Named Executive Officers).
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|
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|
|
|
|
|
|
|
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|
|
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(3) |
|
(4) |
|
|
|
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|
|
|
|
|
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|
|
|
|
|
|
Stock |
|
Option |
|
All Other |
|
|
Name and |
|
|
|
|
|
Salary |
|
Bonus |
|
Awards |
|
Awards |
|
Compen- |
|
|
Principal Position |
|
Year |
|
($) |
|
($) |
|
($) |
|
($) |
|
sation ($) |
|
Total ($) |
Robert T. McNally (1) |
|
|
2008 |
|
|
$ |
175,000 |
|
|
$ |
|
|
|
$ |
|
|
|
$ |
203,351 |
|
|
$ |
1,250 |
|
|
$ |
379,601 |
|
President & |
|
|
2007 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Chief Executive
Officer |
|
|
2006 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Donald G. Hildebrand (2) |
|
|
2008 |
|
|
|
90,000 |
|
|
|
|
|
|
|
|
|
|
|
237,468 |
|
|
|
1,521 |
|
|
|
328,989 |
|
Former President & |
|
|
2007 |
|
|
|
252,577 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
3,375 |
|
|
|
255,952 |
|
Chief Executive
Officer |
|
|
2006 |
|
|
|
57,500 |
|
|
|
50,000 |
|
|
|
|
|
|
|
|
|
|
|
574 |
|
|
|
108,074 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Mark W. Reynolds |
|
|
2008 |
|
|
|
120,740 |
|
|
|
|
|
|
|
|
|
|
|
261,920 |
|
|
|
|
|
|
|
382,660 |
|
Chief Financial
Officer |
|
|
2007 |
|
|
|
92,102 |
|
|
|
10,000 |
|
|
|
|
|
|
|
190,324 |
|
|
|
|
|
|
|
292,426 |
|
|
|
|
2006 |
|
|
|
13,192 |
|
|
|
2,000 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
15,192 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Andrew J. Kandalepas |
|
|
2008 |
|
|
|
225,000 |
|
|
|
|
|
|
|
|
|
|
|
238,592 |
|
|
|
|
|
|
|
463,592 |
|
Senior Vice
President |
|
|
2007 |
|
|
|
205,288 |
|
|
|
10,000 |
|
|
|
|
|
|
|
188,380 |
|
|
|
|
|
|
|
403,668 |
|
|
|
|
2006 |
|
|
|
173,467 |
|
|
|
|
|
|
|
2,400,000 |
|
|
|
|
|
|
|
|
|
|
|
2,573,467 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Harriet L. Robinson |
|
|
2008 |
|
|
|
234,375 |
|
|
|
|
|
|
|
|
|
|
|
159,352 |
|
|
|
313 |
|
|
|
394,040 |
|
Senior
Vice-President, |
|
|
2007 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Research and
Development |
|
|
2006 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(1) |
|
Dr. McNally became our President and Chief Executive Officer effective April 1, 2008. All
compensation amounts above reflect amounts paid to, or earned by, Dr. McNally from that date
through December 31, 2008, and do not include compensation earned by Dr. McNally for service
as a member of our Board of Directors prior to his employment as President and Chief Executive
Officer (see Director Compensation). Such amounts excluded from the table above include
$4,317 in cash compensation received for service on our Board of Directors and $46,773 of
expense recognized for financial statement purposes related to stock options granted for
service on our Board of Directors. At no time did Dr. McNally receive compensation for service
as both our President and Chief Executive Officer and as a member of our Board of Directors at
the same time. |
|
(2) |
|
Mr. Hildebrand retired as our President and Chief Executive Officer effective April 1, 2008.
The salary amounts shown above reflect amounts paid to, or earned by, Mr. Hildebrand through
that date. Subsequent to his retirement, Mr. Hildebrand has been paid for services as Chairman
of our Board of Directors and pursuant to a consulting arrangement; these amounts are not
included in the Director Compensation table. Such amounts excluded from the table above
include $22,500 in cash compensation received for service on our Board of Directors and
$64,000 of cash compensation received pursuant to the |
34
|
|
|
|
|
consulting arrangement. At no time did Mr. Hildebrand receive compensation for service as
both our President and Chief Executive Officer and as a member of our Board of Directors at
the same time. |
|
(3) |
|
Amounts shown in the Option Awards columns represent the dollar amount recognized for
financial statement reporting purposes for grants made in the current and previous fiscal
years, calculated pursuant to the provisions of Financial Accounting Standards Board Statement
of Financial Accounting Standards No. 123 (revised 2004), Share-Based Payment. For a
discussion of the various assumptions made and methods used for determining such amounts, see
footnotes 2 and 7 to our 2008 consolidated financial statements. For 2008, the amounts
reported for Mr. Hildebrand and Dr. Robinson include $237,468 and $158,720, respectively,
related to the extension of the exercise period of stock options granted in prior years. These
stock options were originally granted with an exercise period of 5-7 years and were to expire
beginning in 2009. The extensions were made to adjust the exercise period to 10 years from the
original grant date, consistent with the current stock option grant policies of the Company.
The extensions did not affect the vesting schedule of the grants; all were originally granted
with a 3 year vesting schedule and were fully vested at the time of the extensions. |
|
(4) |
|
Amounts shown in the All Other Compensation column represent employer contributions to the
Companys 401(k) retirement plan. |
Employment Agreement with Robert McNally
On March 20, 2008, GeoVax entered into an Employment Agreement with Robert T. McNally, Ph.D.
to become our President and Chief Executive Officer effective April 1, 2008. The Employment
Agreement has no specified term. The Employment Agreement provided for an initial annual salary of
$200,000 to Dr. McNally, which was increased to $250,000 by the Compensation Committee and the
Board in June 2008. The Board of Directors may also recommend the payment of a discretionary bonus
annually. Dr. McNally is eligible for grants of awards from the GeoVax Labs, Inc. 2006 Equity
Incentive Plan and is entitled to participate in any and all benefits in effect from time-to-time
for employees generally. We may terminate the Employment Agreement, with or without cause. If we
terminate the Employment Agreement without cause, we will be required to give Dr. McNally at least
60 days prior notice of the termination. In the event of termination not for cause, Dr. McNally
will be entitled to one week of severance pay for each full year of service as President and Chief
Executive Officer ($4,808 if terminated in fiscal 2009, paid as salary continuance). Dr. McNally
may terminate the Employment Agreement at any time by giving us 60 days notice. In that event, he
would not receive severance.
Employment Agreement with Mark Reynolds
On February 1, 2008, GeoVax entered into an amended and restated Employment Agreement with
Mark W. Reynolds, our Chief Financial Officer. The Employment Agreement has no specified term. The
Employment Agreement provided for an initial annual salary of $115,000 to Mr. Reynolds, which was
increased to $150,000 by the Compensation Committee and the Board effective January 1, 2009,
commensurate with the increased time commitment provided by Mr. Reynolds. The Board of Directors
may also recommend the payment of a discretionary bonus annually. Mr. Reynolds is eligible for
grants of awards from the GeoVax Labs, Inc. 2006 Equity Incentive Plan and is entitled to
participate in any and all benefits in effect from time-to-time for employees generally. We may
terminate the Employment Agreement, with or without cause. If we terminate the Employment Agreement
without cause, we will be required to give Mr. Reynolds at least 60 days prior notice of the
termination. In the event of termination not for cause, Mr. Reynolds will be entitled to one week
of severance pay for each full year of service as Chief Financial Officer ($8,654 if terminated in
fiscal 2009, paid as salary continuance). Mr. Reynolds may terminate the Employment Agreement at
any time by giving us 60 days notice. In that event, he would not receive severance.
Employment Agreement with Andrew Kandalepas
On February 1, 2007, GeoVax entered into an Employment Agreement with Andrew Kandalepas, our
Senior Vice President. The Employment Agreement has no specified term. The Employment Agreement
provided for an initial annual salary of $210,000 to Mr. Kandalepas, which has subsequently been
adjusted by the Compensation Committee and the Board (currently $225,000). The Board of Directors
may also recommend the payment of a discretionary bonus annually. Mr. Kandalepas is eligible for
grants of awards from the GeoVax Labs, Inc. 2006 Equity Incentive Plan and is entitled to
participate in any and all benefits in effect from time-to-time for employees generally. We may
terminate the Employment Agreement, with or without cause. If we terminate the Employment Agreement
without cause, we will be required to give Mr. Kandalepas at least 60 days prior notice of the
termination. In the event of termination not for cause, Mr. Kandalepas will be entitled to one week
of severance pay for each full year of service as Senior Vice President ($8,654 if terminated in
fiscal 2009, paid as salary continuance). Mr. Kandalepas may terminate the Employment Agreement at
any time by giving us 60 days notice. In that event, he would not receive severance.
35
Employment Agreement with Harriet Robinson
On November 19, 2007, GeoVax entered into an Employment Agreement with Harriet Robinson, our
Senior Vice President, Research and Development. The Employment Agreement has no specified term.
The Employment Agreement provides for an initial annualized salary of $250,000 to Dr. Robinson. Dr.
Robinson initially worked part-time for the Company, and became a full-time employee in February
2008. The Board of Directors may also recommend the payment of a discretionary bonus annually. Dr.
Robinson is eligible for grants of awards from the GeoVax Labs, Inc. 2006 Equity Incentive Plan and
is entitled to participate in any and all benefits in effect from time-to-time for employees
generally. We may terminate the Employment Agreement, with or without cause. If we terminate the
Employment Agreement without cause, we will be required to give Dr. Robinson at least 60 days prior
notice of the termination. In the event of termination not for cause, Dr. Robinson will be entitled
to one week of severance pay for each full year of service ($9,615 if terminated in fiscal 2009,
paid as salary continuance). Dr. Robinson may terminate the Employment Agreement at any time by
giving us 60 days notice. In that event, she would not receive severance.
Potential Payments Upon Termination or Change of Control Mr. Hildebrand
Mr. Hildebrands Consulting Agreement contains provisions such that, if we terminate the
Consulting Agreement without cause, we must give Mr. Hildebrand at least 30 days notice and we will
be required to pay him, as a severance payment, three months compensation. Likewise, if the
Consulting Agreement is terminated due to the death of Mr. Hildebrand, we will be required to pay
his estate three months compensation. If Mr. Hildebrand wishes to terminate the Consulting
Agreement, he must provide us with 30 days notice, and will not receive severance.
Change-In-Control Provisions of Our 2006 Equity Incentive Plan
Our 2006 Equity Incentive Plan (the Plan) contains provisions that could lead to an
accelerated vesting of options or other awards. In the event of certain change-in-control
transactions described in the Plan:
|
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outstanding options or other awards under the Plan may be assumed, converted or
replaced; |
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|
|
the successor corporation may substitute equivalent options or other awards or
provide substantially similar consideration to Plan participants as was provided to
stockholders (after taking into account the existing provisions of the options or other
awards); or |
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|
|
|
the successor corporation may replace options or awards with substantially similar
shares or other property. |
In the event the successor corporation (if any) refuses to assume or substitute options or
other awards as described (i) the vesting of any or all options or awards granted pursuant to the
Plan will accelerate upon the change-in-control transaction, and (ii) any or all options granted
pursuant to the Plan will become exercisable in full prior to the consummation of the
change-in-control transaction at such time and on such conditions as the Compensation Committee
determines. If the options are not exercised prior to the consummation of the change-in-control
transaction, they shall terminate at such time as determined by the Compensation Committee. Subject
to any greater rights granted to Plan participants under the Plan, in the event of the occurrence
of a change-in-control transaction any outstanding options or other awards will be treated as
provided in the applicable agreement or plan of merger, consolidation, dissolution, liquidation, or
sale of assets.
36
GRANTS OF PLAN-BASED AWARDS
The following table sets forth the stock and option awards, including non-equity incentive
awards, granted to the Named Executive Officers for the year ended December 31, 2008. There were no
stock awards.
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(2) |
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All Other |
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(3) |
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Grant |
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Stock |
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All Other |
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Awards: |
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Option |
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Exercise |
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Fair |
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Number |
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Awards: |
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Or |
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Value |
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Of |
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Number |
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Base |
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Of |
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Shares |
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Of |
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Price |
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Stock |
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Estimated Future Payouts Under |
|
Estimated Future Payouts Under |
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Of |
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Securities |
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Of |
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And |
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Non-Equity Incentive Plan Awards |
|
Equity Incentive Plan Awards |
|
Stock |
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Underlying |
|
Option |
|
Option |
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Grant |
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Threshold |
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Target |
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Maximum |
|
Threshold |
|
Target |
|
Maximum |
|
Or Units |
|
Options |
|
Awards |
|
Awards |
Name |
|
Date |
|
($) |
|
($) |
|
($) |
|
($) |
|
($) |
|
($) |
|
(#) |
|
(#) |
|
($/Sh) |
|
($) |
Donald Hildebrand |
|
|
6/17/08 |
|
|
$ |
|
|
|
$ |
|
|
|
$ |
|
|
|
$ |
|
|
|
$ |
|
|
|
$ |
|
|
|
|
|
|
|
|
8,895,630 |
|
|
$ |
0.045 |
|
|
$ |
237,468 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Andrew Kandalepas |
|
|
12/11/08 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
500,000 |
|
|
|
0.11 |
|
|
|
45,500 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Robert McNally |
|
|
6/17/08 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
500,000 |
|
|
|
0.11 |
|
|
|
45,500 |
|
|
|
|
12/11/08 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
2,400,000 |
|
|
|
0.17 |
|
|
|
345,600 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Mark Reynolds |
|
|
12/11/08 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
500,000 |
|
|
|
0.11 |
|
|
|
45,500 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Harriet Robinson |
|
|
12/11/08 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
500,000 |
|
|
|
0.11 |
|
|
|
45,500 |
|
|
|
|
6/17/08 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
8,895,630 |
|
|
|
0.04 |
|
|
|
158,720 |
|
|
|
|
(1) |
|
The exercise price for options is the closing trading price of the common shares of the
Company on the on the day of the grant. The grant date is determined by the Compensation
Committee. All stock option grants during 2008 (excluding the stock option extensions
discussed below) vest over a 3-year period from the date of grant. |
|
(2) |
|
Compensation expense is recognized for all share-based payments based on the grant date fair
value estimated for financial reporting purposes. For a discussion of the various assumptions
made and methods used for determining such amounts, see footnotes 2 and 7 to our 2008
consolidated financial statements. The amounts shown for the June 17, 2008 grants to Mr.
Hildebrand and Dr. Robinson represent the incremental grant date fair values of the extended
stock option grants (see discussion below) as compared to the fair values of the original
grants. |
|
(3) |
|
On June 17, 2008, the Company extended the exercise period of stock options granted in prior
years to Mr. Hildebrand and Dr. Robinson. These stock options were originally granted with an
exercise period of 5-7 years and were to expire beginning in 2009. The extensions were made to
adjust the exercise period to 10 years from the original grant date, consistent with the
current stock option grant policies of the Company. The extensions did not affect the vesting
schedule of the grants; all were originally granted with a 3-year vesting schedule and were
fully vested at the time of the extensions. |
37
OUTSTANDING EQUITY AWARDS AT FISCAL YEAR-END
The following table sets forth certain information with respect to unexercised options
previously awarded to our Named Executive Officers as of December 31, 2008. There were no stock
awards outstanding.
Option Awards
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Equity |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Incentive |
|
|
|
|
|
|
|
|
|
|
Number of |
|
Plan Awards: |
|
|
|
|
|
|
|
|
|
|
Securities |
|
Number of |
|
|
|
|
|
|
(1) |
|
Underlying |
|
Securities |
|
|
|
|
|
|
Number of Securities |
|
Unexercised |
|
Underlying |
|
|
|
|
|
|
Underlying Unexercised |
|
Options (#) |
|
Unexercised Unearned |
|
Option Exercise |
|
Option |
Name |
|
Options (#) Exercisable |
|
Unexercisable |
|
Options (#) |
|
Price ($) |
|
Expiration Date |
Donald Hildebrand |
|
|
8,895,630 |
|
|
|
|
|
|
|
|
|
|
|
0.0445 |
|
|
|
12/20/12 |
|
|
|
|
8,895,630 |
(1) |
|
|
|
|
|
|
|
|
|
|
0.0445 |
|
|
|
2/5/14 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Andrew Kandalepas |
|
|
|
|
|
|
500,000 |
(2) |
|
|
|
|
|
|
0.11 |
|
|
|
12/11/18 |
|
|
|
|
1,200,000 |
|
|
|
600,000 |
(3) |
|
|
|
|
|
|
0.355 |
|
|
|
3/14/17 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Robert McNally |
|
|
|
|
|
|
500,000 |
(2) |
|
|
|
|
|
|
0.11 |
|
|
|
12/11/18 |
|
|
|
|
|
|
|
|
2,400,000 |
(4) |
|
|
|
|
|
|
0.17 |
|
|
|
6/17/18 |
|
|
|
|
166,667 |
|
|
|
333,333 |
(5) |
|
|
|
|
|
|
0.161 |
|
|
|
12/5/17 |
|
|
|
|
880,000 |
|
|
|
440,000 |
(6) |
|
|
|
|
|
|
0.355 |
|
|
|
3/14/17 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Mark Reynolds |
|
|
|
|
|
|
500,000 |
(2) |
|
|
|
|
|
|
0.11 |
|
|
|
12/11/18 |
|
|
|
|
166,667 |
|
|
|
333,333 |
(5) |
|
|
|
|
|
|
0.161 |
|
|
|
12/5/17 |
|
|
|
|
1,200,000 |
|
|
|
600,000 |
(3) |
|
|
|
|
|
|
0.355 |
|
|
|
3/14/17 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Harriet Robinson |
|
|
|
|
|
|
500,000 |
(2) |
|
|
|
|
|
|
0.11 |
|
|
|
12/11/18 |
|
|
|
|
8,895,630 |
(1) |
|
|
|
|
|
|
|
|
|
|
0.04 |
|
|
|
2/5/14 |
|
|
|
|
(1) |
|
On June 17, 2008, the expiration dates of these stock option awards to Mr. Hildebrand and Dr.
Robinson were extended by five years from February 5, 2009 to February 5, 2014. |
|
(2) |
|
These stock options vest and become exercisable in three equal installments on December 11,
2009, 2010 and 2011. |
|
(3) |
|
These stock options vest and become exercisable on September 30, 2009. |
|
(4) |
|
These stock options vest and become exercisable in three equal installments on June 17, 2009,
2010 and 2011. |
|
(5) |
|
These stock options vest and become exercisable in two equal installments on December 5, 2010
and 2011. |
|
(6) |
|
These stock options vest and become exercisable on December 5, 2009. |
38
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 stockholders. In December 2006, our Board of
Directors 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. To
maintain the tax-qualified status of all incentive options issued pursuant to the Plan, we
submitted this amendment to our shareholders for approval at the Companys 2007 Annual Meeting of
Shareholders. The amendment was not approved by the Companys stockholders. The following table
sets forth information as of December 31, 2008, with respect to our equity compensation plans.
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Number of securities |
|
|
|
|
|
|
|
|
|
|
remaining available for |
|
|
Number of securities |
|
|
|
|
|
future issuance under |
|
|
to be issued upon |
|
Weighted-average |
|
equity compensation |
|
|
exercise of |
|
exercise price of |
|
plans (excluding |
|
|
outstanding options, |
|
outstanding options, |
|
securities reflected in |
|
|
warrants and rights |
|
warrants and rights |
|
column (a)) |
|
|
(a) |
|
(b) |
|
(c) |
Equity compensation
plans approved by
security holders |
|
|
35,876,450 |
|
|
$ |
0.11 |
|
|
|
-0- |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Equity compensation
plans not approved
by security holders |
|
|
11,071,307 |
|
|
$ |
0.18 |
|
|
|
3,928,693 |
|
The Plan became effective on September 28, 2006. Unless the Plan is earlier terminated in
accordance with its provisions, no stock incentives will be granted under the Plan after the
earlier of ten years from the effective date, or the date on which all of the shares reserved for
the Plan have been issued or are no longer available for use under the Plan.
The Plan is administered by the Compensation Committee of the Board of Directors.
The Board of Directors and the Committee may grant the following stock incentives under the
Plan (each individually, a Stock Incentive):
|
|
|
stock options to purchase shares of common stock, including options intended to
qualify under Section 422 of the Code (incentive stock options) and options not
intended to qualify under Section 422 of the Code (non-qualified stock options); |
|
|
|
|
restricted stock awards; and |
|
|
|
|
restricted stock bonus. |
Awards of Stock Incentives under the Plan may be made to employees of GeoVax and its
subsidiaries, non-employee directors, and consultants or advisors that provide services (other than
the offering, sale or marketing of our securities) to us or to our subsidiaries (collectively, the
Participants). Only employees are eligible to receive a grant of incentive stock options.
39
DIRECTOR COMPENSATION
The following table sets forth information concerning the compensation earned for service on
our Board of Directors during the last fiscal year by each individual who served as a director at
any time during the fiscal year.
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Change |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
in Pension |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Non-Equity |
|
Value and |
|
|
|
|
|
|
Fees |
|
|
|
|
|
|
|
|
|
Incentive |
|
Non-qualified |
|
All |
|
|
|
|
Earned |
|
|
|
|
|
(4)(5) |
|
Plan |
|
Deferred |
|
Other |
|
|
|
|
or Paid |
|
Stock |
|
Option |
|
Compen- |
|
Compen- |
|
Compen- |
|
|
|
|
in Cash |
|
Awards |
|
Awards |
|
sation |
|
sation |
|
sation |
|
Total |
Name |
|
($) |
|
($) |
|
($) |
|
($) |
|
Earnings |
|
($) |
|
($) |
Donald Hildebrand
(1) |
|
$ |
22,500 |
|
|
$ |
|
|
|
$ |
|
|
|
$ |
|
|
|
$ |
|
|
|
$ |
64,000 |
|
|
$ |
86,500 |
|
Andrew Kandalepas
(2) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Dean Kollintzas |
|
|
10,983 |
|
|
|
|
|
|
|
198,464 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
209,447 |
|
Robert McNally (3) |
|
|
4,317 |
|
|
|
|
|
|
|
46,773 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
51,090 |
|
Harriet Robinson (2) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
John Spencer |
|
|
26,963 |
|
|
|
|
|
|
|
198,464 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
225,427 |
|
Peter Tsolinas |
|
|
4,613 |
|
|
|
|
|
|
|
23,432 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
28,045 |
|
|
|
|
(1) |
|
Mr. Hildebrand retired as our President and CEO effective April 1, 2008. Amounts shown in the
table represent cash payments and stock option awards associated with his service as a
director and other compensation subsequent to his employment as our President and CEO.
Subsequent to April 1, we paid Mr. Hildebrand pursuant to a consulting agreement, which
amounts are included under All Other Compensation above. All amounts related to his
employment as our President and CEO during 2008 and prior years are included in the Summary
Compensation Table. |
|
(2) |
|
Mr. Kandalepas and Dr. Robinson, who were employees of the Company during 2008, received no
compensation for their service as directors. All amounts related to their employment as Named
Executive Officers during 2008 and prior years are included in the Summary Compensation
Table. |
|
(3) |
|
Amounts reported for Dr. McNally relate to cash payments and stock option awards associated
with his service as a director prior to his employment as our President and Chief Executive
Officer effective April 1, 2008. As President and CEO, Dr. McNally receives no compensation
for his service as a director. All amounts related to his employment as our President and CEO
during 2008 are included in the Summary Compensation Table. |
|
(4) |
|
Amounts shown in the table represent the dollar amount recognized for financial statement
reporting purposes in 2008 for awards and grants made in the current and previous fiscal
years, calculated pursuant to the provisions of Financial Accounting Standards Board Statement
of Financial Accounting Standards No. 123 (revised 2004), Share-Based Payment. For a
discussion of the various assumptions made and methods used for determining such amounts, see
footnotes 2 and 7 to our 2008 consolidated financial statements. On December 11, 2008, Mr.
Kollintzas and Mr. Spencer were each granted options to purchase 500,000 shares of our Common
Stock, each with a grant date fair value under FAS123(R) of $45,500. |
40
|
|
|
|
|
On August 20, 2008 Mr. Tsolinas was granted options to purchase 1,320,000 shares of our Common
Stock with a grant date fair value under FAS123(R) of $187,440. |
|
(5) |
|
The table below shows the aggregate numbers of stock awards and option awards outstanding for
each non-employee director as of December 31, 2008. |
|
|
|
|
|
|
|
Aggregate Option |
|
|
Awards |
|
|
Outstanding as of December 31, 2008 |
Name |
|
(#) |
Donald Hildebrand |
|
|
17,791,260 |
|
Dean Kollintzas |
|
|
2,320,000 |
|
John Spencer |
|
|
2,320,000 |
|
Peter Tsolinas |
|
|
1,320,000 |
|
Director Compensation Plan
In March 2007, the Board of Directors approved a recommendation from the Compensation
Committee for director compensation (the Director Compensation Plan). The Director Compensation
Plan applies only to non-employee directors. Directors who are employees of the Company receive no
compensation for their service as directors or as members of committees. Each non-employee director
receives an annual retainer of $2,000 (paid quarterly) for service as a member of the Audit
Committee and $1,250 for service as a member of the Compensation Committee. The Chairman of the
Audit Committee receives an annual retainer of $9,000, and the Chairman of the Compensation
Committee receives an annual retainer of $6,000 which retainers are also paid quarterly.
Non-employee directors also receive fees for each Board or Committee meeting attended as follows:
$1,500 per Board meeting, $1,000 per Committee meeting chaired, and $500 per Committee meeting
attended as a non-Chair member. Meetings attended telephonically are paid at lower rates ($750,
$750 and $400, respectively).
In March 2008, the Board of Directors approved a recommendation from the Compensation
Committee to modify the Director Compensation Plan to provide for compensation for a non-employee
Chairman of the Board. A non-employee Chairman of the Board will receive an annual retainer of
$25,000 (paid quarterly) and will not be entitled to additional fees for meetings attended.
Non-employee directors each receive an automatic grant of options to purchase 1,320,000 shares of
common stock on the date that such non-employee director is first elected or appointed to the
Board.
The Director Compensation Plan currently does not provide a formula for stock option grants to
directors upon their re-election to the Board, or otherwise, but the compensation plan may be
modified in the future; such option grants are currently determined by Board, upon recommendation
by the Compensation Committee based on the Compensation Committees annual deliberations and review
of the director compensation structure of similar companies. At its meeting in December 2008, upon
a recommendation of the Compensation Committee, the Board awarded an annual stock option grant of
500,000 shares to its non-employee members, with the exception of Mr. Hildebrand and Mr. Tsolinas.
Mr. Hildebrand declined the stock option grant and Mr. Tsolinas did not receive the grant due to
his having recently received (in August 2008) a stock option grant in connection with his initial
election to the Board.
All directors are reimbursed for expenses incurred in connection with attending meetings of the
Board of Directors and committees.
41
CERTAIN RELATIONSHIPS AND RELATED TRANSACTIONS
Policies and Procedures for Approval of Related Person Transactions
Our Audit Committee is responsible for reviewing and approving all transactions or
arrangements between the Company and any of our directors, officers, principal stockholders or any
of their respective affiliates, associates or related parties, other than transactions with
officers which are covered by the duties of the Compensation Committee. In determining whether to
approve or ratify a related party transaction, the Audit Committee will discuss the transaction
with management and will consider all relevant facts and circumstances available to it including:
|
|
|
whether the terms of the transaction are fair to the Company and at least as
favorable to the Company as would apply if the transaction did not involve a related
party; |
|
|
|
|
whether there are demonstrable business reasons for the Company to enter into the
transaction; |
|
|
|
|
whether the transaction would impair the independence of an outside director; and |
|
|
|
|
whether the transaction would present an improper conflict of interest for any
director or executive officer, taking into account the size of the transaction, the
direct or indirect nature of the related partys interest in the transaction and the
ongoing nature of any proposed relationship, and any other factors the Audit Committee
deems relevant. |
Consulting Agreement with Donald Hildebrand
In order to assist with the transition of certain duties to Dr. McNally, Donald G. Hildebrand,
our then current President and Chief Executive Officer, entered into a Consulting Agreement with us
on March 20, 2008. Aside from his duties as a consultant, Mr. Hildebrand also continues to serve as
Chairman of our Board of Directors. The term of the Consulting Agreement began on April 1, 2008 and
will end on December 31, 2009. During the month of April 2008, Mr. Hildebrand received $22,500 as
compensation for his services (equivalent to his salary as President and Chief Executive Officer).
Beginning on May 1, 2008 and continuing through December 31, 2008, Mr. Hildebrand provided us with
at least 32 hours of service per month and was paid at the rate of $250 per hour. Beginning on
January 1, 2009 and continuing through December 31, 2009, Mr. Hildebrand will provide us with at
least 16 hours of service per month and will be paid at the rate of $300 per hour. The Board of
Directors may, in its discretion, recommend the payment of an annual bonus. We also pay Mr.
Hildebrands medical and dental coverage through the term of the Consulting Agreement. Mr.
Hildebrand received $64,000, in the aggregate, for services rendered under the Consulting Agreement
in 2008, including medical and dental insurance coverage. We may terminate the Consulting Agreement
with or without cause. If we terminate the Consulting Agreement without cause, we must give Mr.
Hildebrand at least 30 days notice and we will be required to pay him, as a severance payment,
three months compensation ($14,400). Likewise, if the Consulting Agreement is terminated due to the
death of Mr. Hildebrand, we will be required to pay his estate three months compensation. If Mr.
Hildebrand wishes to terminate the Consulting Agreement, he must provide us with at least 30 days
notice, and no severance payments will be due to him upon termination.
Transactions with Emory University
Emory University (Emory) is a significant stockholder of the Company, and our primary
product candidates are based on technology rights subject to a license agreement with Emory (the
Emory License). The Emory License, among other contractual obligations, requires payments based
on milestone achievements, royalties on sales by the Company or on payments to the Company by our
sublicensees, and payment of maintenance fees in the event certain milestones are not met within
the time periods specified in the contract. We 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. We are also 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 $102,141 and $243,653 for the years
ended December 31, 2008 and 2007, respectively.
In June 2008, we entered into two subcontracts with Emory for the purpose of conducting
research and development activities associated with a grant from the National Institutes of Health.
During 2008, we recorded $723,887 of expense associated with these subcontracts. All amounts paid
to Emory under these subcontracts are reimbursable to us pursuant to the NIH grant.
42
SECURITY OWNERSHIP OF PRINCIPAL STOCKHOLDERS, DIRECTORS AND OFFICERS
Based solely upon information made available to us, the following table sets forth information
with respect to the beneficial ownership of our common stock as of June 9, 2009 by (1) each
director; (2) each of our Named Executive Officers; (3) all executive officers and directors as a
group; and (4) each additional person who is known by us to beneficially own more than 5% of our
common stock. Except as otherwise indicated, the holders listed below have sole voting and
investment power with respect to all shares of common stock beneficially owned by them.
|
|
|
|
|
|
|
|
|
|
|
Number of Shares |
|
|
|
|
Beneficially |
|
Percent |
Name and Address of Beneficial Owner (1) |
|
Owned |
|
Of Class (2) |
Directors and Executive Officers: |
|
|
|
|
|
|
|
|
Donald G. Hildebrand (3) |
|
|
72,805,107 |
|
|
|
9.5 |
% |
Andrew J. Kandalepas (4) |
|
|
22,490,065 |
|
|
|
3.0 |
% |
Dean G. Kollintzas (5) |
|
|
1,046,667 |
|
|
|
* |
|
Robert T. McNally (6) |
|
|
2,464,424 |
|
|
|
* |
|
Mark W. Reynolds (7) |
|
|
1,396,667 |
|
|
|
* |
|
Harriet L. Robinson (8) |
|
|
65,600,921 |
|
|
|
8.6 |
% |
John N. Spencer, Jr. (9) |
|
|
1,176,667 |
|
|
|
* |
|
Peter M. Tsolinas (10) |
|
|
35,277,057 |
|
|
|
4.6 |
% |
|
|
|
|
|
|
|
|
|
All executive officers and directors as a group (8 persons) (11) |
|
|
202,257,566 |
|
|
|
25.3 |
% |
|
|
|
|
|
|
|
|
|
Other 5% Stockholders: |
|
|
|
|
|
|
|
|
Emory University (12) |
|
|
233,905,253 |
|
|
|
31.1 |
% |
Stavros Papageorgiou (13) |
|
|
58,709,915 |
|
|
|
7.5 |
% |
|
|
|
* |
|
Less than 1% |
|
(1) |
|
Except as otherwise indicated, the business address of each director and executive officer
listed is c/o GeoVax Labs, Inc., 1256 Briarcliff Road, Suite 500, Atlanta, Georgia 30306. |
|
(2) |
|
This table is based upon information supplied by officers and directors, and with respect to
principal stockholders, Schedules 13D and 13G filed with the SEC. Beneficial ownership is
determined in accordance with the rules of the SEC. Applicable percentage ownership is based
on 751,803,510 shares of common stock outstanding as of June 9, 2009. In computing the number
of shares beneficially owned by a person and the percentage ownership of that person, shares
of common stock subject to options currently exercisable, or exercisable within 60 days of
June 9, 2009, are deemed outstanding. |
|
(3) |
|
Includes options to purchase 17,791,260 shares of common stock exercisable within 60 days of
June 9, 2009. Includes 500,000 shares owned by his spouse. |
|
(4) |
|
Includes options to purchase 1,200,000 shares of common stock exercisable within 60 days of
June 9, 2009. Includes 50,000 shares held by daughter and 15,000 shares held by CadServ, Inc.
over which Mr. Kandalepas exercises voting control. |
|
(5) |
|
Includes options to purchase 1,046,667 shares of common stock exercisable within 60 days of
June 9, 2009. |
|
(6) |
|
Includes options to purchase 1,846,667 shares of common stock exercisable within 60 days of
June 9, 2009. Includes 617,757 shares, representing Mr. McNallys 50% ownership in NuTek
Biomedical, LLC, which owns an aggregate 1,235,514 shares. |
|
(7) |
|
Includes options to purchase 1,366,667 shares of common stock exercisable within 60 days of
June 9, 2009. |
|
(8) |
|
Includes options to purchase 8,895,630 shares of common stock exercisable within 60 days of
June 9, 2009 |
|
(9) |
|
Includes options to purchase 1,046,667 shares of common stock exercisable within 60 days of
June 9, 2009. |
43
|
|
|
(10) |
|
Includes warrants to purchase 13,790,323 shares of common stock exercisable within 60 days of
June 9, 2009 |
|
(11) |
|
Includes options and warrants to purchase 46,983,881 shares of common stock exercisable
within 60 days of June 9, 2009. |
|
(12) |
|
The address for this stockholder is Administration Building 101, 201 Dowman Drive, Atlanta,
Georgia 30322. |
|
(13) |
|
The address for this stockholder is 77, Charilaou Trikoupi Str, 14563 Kifissia Greece.
Includes warrants to purchase 27,734,031 shares of common stock exercisable within 60 days of
June 9, 2009 and 25,192,013 shares held by his spouse. |
44
THE FUSION TRANSACTION
General
On May 8, 2008, we entered into the Purchase Agreement with Fusion Capital. Under the Purchase
Agreement, Fusion Capital is obligated, under certain conditions, to purchase shares from us in an
aggregate amount of up to $10.0 million from time to time over a twenty-five (25) month period.
Under the terms of the Purchase Agreement, Fusion Capital received a commitment fee consisting of
2,480,510 shares of our common stock. Also, we agreed to issue to Fusion Capital up to an
additional 2,480,510 shares as a commitment fee pro rata as we receive the up to $10.0 million of
future funding. As of June 9, 2009, we have issued 267,896 of the 2,480,510 shares. As of June 9,
2009, there were 752,564,992 shares outstanding (including shares held by non-affiliates) excluding
up to 28,530,403 shares offered by Fusion Capital pursuant to this prospectus which we have not yet
issued to Fusion Capital. If all of such 28,530,403 shares were issued and outstanding as of the
date hereof, the 40,161,020 shares would represent 5.1% of the total common stock outstanding or
10.3% of the non-affiliate shares outstanding as of the date hereof. The number of shares
ultimately offered for sale by Fusion Capital is dependent upon the number of shares purchased by
Fusion Capital under the Purchase Agreement.
Under the Purchase Agreement and the registration rights agreement we are required to register
and have included in the offering for resale by Fusion Capital pursuant to this prospectus:
|
|
|
2,480,510 shares which were issued as a commitment fee, which, subject to certain
exceptions, may not be sold by Fusion Capital until the earlier of 500 days from May 8,
2008, or the termination of the Purchase Agreement; |
|
|
|
|
200,000 shares which we issued to Fusion Capital as an expense reimbursement; |
|
|
|
|
an additional 2,480,510 shares which we may issue in the future as a commitment fee
pro rata as we receive the up to $10.0 million of future funding; and |
|
|
|
|
35.0 million shares which we may sell to Fusion Capital. |
All 40,161,020 shares are being offered pursuant to this prospectus. Under the Purchase
Agreement, we have the right but not the obligation to sell more than the 35.0 million shares to
Fusion Capital. As of the date hereof, we do not have any plans or intent to sell to Fusion Capital
any shares beyond this 35.0 million shares. However, if we elect to sell more than the 35.0 million
shares (which we have the right but not the obligation to do), we must first register under the
Securities Act of 1933 (the Securities Act) any additional shares we may elect to sell to Fusion
Capital before we can sell such additional shares, which could cause substantial dilution to our
shareholders.
We did not have the right to commence any sales of our shares to Fusion Capital until the SEC
declared effective the registration statement of which this prospectus is a part. The registration
statement was declared effective on July 1, 2008 and the conditions to commence funding were
satisfied. Generally, we have the right but not the obligation from time to time to sell our shares
to Fusion Capital in amounts between $80,000 and $1.0 million depending on certain conditions. We
have the right to control the timing and amount of any sales of our shares to Fusion Capital
subject to certain limitations. The purchase price of the shares will be determined pursuant to a
formula based upon the market price of our shares without any fixed discount at the time of each
sale. Fusion Capital shall not have the right nor the obligation to purchase any shares of our
common stock on any business day that the price of our common stock is below $0.05. There are no
negative covenants, restrictions on future fundings, penalties or liquidated damages in the
Purchase Agreement or the registration rights agreement. The Purchase Agreement may be terminated
by us at any time at our discretion without any cost to us.
Purchase Of Shares Under The Purchase Agreement
Under the Purchase Agreement, we may direct Fusion Capital to purchase up to $80,000 of our
common stock by giving notice (so long as it has been at least four business days since the last
purchase). The purchase price per share is equal to the lesser of:
|
|
|
the lowest sale price of our common stock on the purchase date; or |
|
|
|
|
the average of the three (3) lowest closing sale prices of our common stock during
the twelve (12) consecutive business days prior to the date of a purchase by Fusion
Capital. |
45
The purchase price will be equitably adjusted for any reorganization, recapitalization, non-cash
dividend, stock split, or other similar transaction occurring during the business days used to
compute the purchase price. We may direct Fusion Capital to make multiple purchases from time to
time in our sole discretion; no sooner than every four business days.
Our Right To Increase the Amount to be Purchased
In addition to purchases of up to $80,000, we may elect to require Fusion Capital to purchase
our shares in an amount up to $100,000 on a single business day provided that our share price is
not below $0.11 during the two business days prior to and on the purchase date. We may increase
this amount to up to $250,000 if our share price is not below $0.20 during the two business days
prior to and on the purchase date. This amount may also be increased to up to $500,000 if our share
price is not below $0.40 during the two business days prior to and on the purchase date. This
amount may be increased to up to $1.0 million if our share price is not below $0.80 during the two
business days prior to and on the purchase date. We may direct Fusion Capital to make multiple
large purchases from time to time in our sole discretion; however, at least three business days
must have passed since the most recent large purchase was completed. The price at which our common
stock would be purchased in this type of larger purchases will be the lesser of (i) the lowest sale
price of our common stock on the purchase date and (ii) the lowest purchase price (as described in
the bullet points above) during the previous ten business days prior to the purchase date.
Minimum Purchase Price
Under the Purchase Agreement, we have set a minimum purchase price (floor price) of $0.05.
However, Fusion Capital shall not have the right nor the obligation to purchase any shares of our
common stock in the event that the purchase price would be less than the floor price. Specifically,
Fusion Capital shall not have the right or the obligation to purchase shares of our common stock on
any business day that the market price of our common stock is below $0.05.
Events of Default
Generally, Fusion Capital may terminate the Purchase Agreement without any liability or
payment to the Company upon the occurrence of any of the following events of default:
|
|
|
the effectiveness of the registration statement of which this prospectus is a part of
lapses for any reason (including, without limitation, the issuance of a stop order) or
is unavailable to Fusion Capital for sale of our common stock offered hereby and such
lapse or unavailability continues for a period of ten consecutive business days or for
more than an aggregate of thirty business days in any 365-day period; |
|
|
|
|
suspension by our principal market (the over-the-counter bulletin board) of our
common stock from trading for a period of three consecutive business days; |
|
|
|
|
the de-listing of our common stock from our principal market provided our common
stock is not immediately thereafter trading on the Nasdaq Global Market, the Nasdaq
Capital Market, the New York Stock Exchange or the American Stock Exchange; |
|
|
|
|
the transfer agents failure for five business days to issue to Fusion Capital shares
of our common stock which Fusion Capital is entitled to under the Purchase Agreement; |
|
|
|
|
any material breach of the representations or warranties or covenants contained in
the Purchase Agreement or any related agreements which has or which could have a
material adverse effect on us subject to a cure period of five business days; or |
|
|
|
|
any participation or threatened participation in insolvency or bankruptcy proceedings
by or against us. |
Our Termination Rights
We have the unconditional right at any time for any reason to give notice to Fusion Capital
terminating the Purchase Agreement without any cost to us.
No Short-Selling or Hedging by Fusion Capital
Fusion Capital has agreed that neither it nor any of its affiliates shall engage in any direct
or indirect short-selling or hedging of our common stock during any time prior to the termination
of the Purchase Agreement.
46
Effect of Performance of the Purchase Agreement on Our Shareholders
All 40,161,020 shares registered in this offering are expected to be freely tradable when sold
pursuant to this prospectus. It is anticipated that shares registered in this offering will be sold
over a period of up to 25 months from July 1, 2008. The sale by Fusion Capital of a significant
amount of shares registered in this offering at any given time could cause the market price of our
common stock to decline and to be highly volatile. Fusion Capital may ultimately acquire all, some
or none of 28,530,403 shares of common stock not yet issued but registered in this offering. After
Fusion Capital has acquired such shares, it may sell all, some or none of such shares. Therefore,
sales to Fusion Capital by us under the agreement may result in substantial dilution to the
interests of other holders of our common stock. However, we have the right to control the timing
and amount of any sales of our shares to Fusion Capital and the agreement may be terminated by us
at any time at our discretion without any cost to us.
In connection with entering into the agreement, we authorized the sale to Fusion Capital of up
to 35.0 million shares of our common stock. The number of shares ultimately offered for sale by
Fusion Capital under this prospectus is dependent upon the number of shares purchased by Fusion
Capital under the agreement. As of June 9, 2009, we have sold 8,862,211 shares to Fusion Capital,
and received proceeds of $1,080,000, or an average of $0.12 per share. The following table sets
forth the amount of remaining proceeds we would receive from Fusion Capital from the sale of shares
at varying purchase prices:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Percentage of Outstanding |
|
Aggregate Proceeds from the Sale |
|
|
|
|
|
|
Number of Shares to |
|
Shares After Giving Effect to |
|
of Shares |
Assumed Average |
|
|
|
be Issued if Full |
|
the Issuance to Fusion |
|
to Fusion Capital Under the |
Purchase Price |
|
|
|
Purchase |
|
Capital(1) |
|
Purchase Agreement |
$ |
0.10 |
|
|
|
|
|
26,317,789 |
|
|
|
3.5 |
% |
|
$ |
2,631,779 |
|
$ |
0.26 |
(2) |
|
|
|
|
26,317,789 |
|
|
|
3.5 |
% |
|
$ |
6,842,625 |
|
$ |
0.30 |
|
|
|
|
|
26,317,789 |
|
|
|
3.5 |
% |
|
$ |
7,895,337 |
|
$ |
0.40 |
|
|
|
|
|
22,300,000 |
|
|
|
2.9 |
% |
|
$ |
8,920,000 |
|
$ |
0.50 |
|
|
|
|
|
17,840,000 |
|
|
|
2.3 |
% |
|
$ |
8,920,000 |
|
|
|
|
(1) |
|
The denominator is based on 752,564,992 shares outstanding as of June 9, 2009, which includes
the 8,188,625 shares (11,630,617 shares sold plus 2,948,406 commitment fee shares) previously
issued to Fusion Capital and the number of shares set forth in the adjacent column. The
numerator is based on the number of shares issuable under the Purchase Agreement at the
corresponding assumed purchase price set forth in the adjacent column. |
|
(2) |
|
Closing sale price of our shares on June 9, 2009. |
47
SELLING STOCKHOLDER
The following table presents information regarding the selling stockholder. Neither the
selling stockholder nor any of its affiliates has held a position or office, or had any other
material relationship, with us.
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Shares to be Sold |
|
|
|
|
|
|
|
|
|
|
|
|
in the Offering |
|
|
|
|
|
|
|
|
|
|
|
|
Assuming The |
|
|
|
|
|
|
|
|
Percentage of |
|
Company Issues The |
|
Percentage of |
|
|
Shares Beneficially |
|
Outstanding Shares |
|
Maximum Number of |
|
Outstanding Shares |
|
|
Owned Before |
|
Beneficially Owned |
|
Shares Under the |
|
Beneficially Owned |
Selling Stockholder |
|
Offering |
|
Before Offering (1) |
|
Purchase Agreement |
|
After Offering(1) |
Fusion Capital Fund II, LLC (2) |
|
|
2,680,510 |
(3) |
|
|
0.4 |
% |
|
|
40,161,020 |
|
|
|
0 |
% |
|
|
|
(1) |
|
Applicable percentage of ownership is based on 743,414,885 shares of our common stock
outstanding as of June 26, 2008 (prior to commencement of the offering), together with
securities exercisable or convertible into shares of common stock within sixty days of June
26, 2008 (prior to commencement of the offering), for the selling stockholder. Beneficial
ownership is determined in accordance with the rules of the SEC and generally includes voting
or investment power with respect to securities. Shares of common stock are deemed to be
beneficially owned by the person holding such securities for the purpose of computing the
percentage of ownership of such person, but are not treated as outstanding for the purpose of
computing the percentage ownership of any other person. |
|
(2) |
|
Steven G. Martin and Joshua B. Scheinfeld, the principals of Fusion Capital, are deemed to be
beneficial owners of all of the shares of common stock owned by Fusion Capital. Messrs. Martin
and Scheinfeld have shared voting and disposition power over the shares being offered under
this prospectus. |
|
(3) |
|
We have included in this prospectus 40,161,020 shares in the aggregate. The numbers in the
table are as of June 26, 2008, prior to the commencement of the offering. As of the date
hereof the 40,161,020 shares consist of the following: (1) 2,708,718 shares which have already
been issued as a commitment fee, (2) 200,000 shares which we have issued to Fusion Capital as
an expense reimbursement, (3) 8,682,211 shares sold to Fusion under the Purchase Agreement (4)
up to an additional 26,317,789 shares that we may sell to Fusion Capital and (5) up to an
additional 2,212,614 shares issuable in the future as a commitment fee pro rata as we receive
the up to $8,920,000 million of future funding. Therefore we may issue to Fusion Capital up to
an additional 28,530,403 shares under the purchase agreement. Fusion Capital does not
presently beneficially own any of these 28,530,403 shares as determined in accordance with the
rules of the SEC. |
USE OF PROCEEDS
This prospectus relates to shares of our common stock that may be offered and sold from time
to time by Fusion Capital, the selling stockholder. We will receive no direct proceeds from the
sale of shares of common stock in this offering. However, we have received $1,080,000 through sales
to Fusion Capital through June 9, 2009, and we may receive up to $8,920,000 million in proceeds
from the sale of up to 26,317,789 shares of our common stock remaining to be sold to Fusion Capital
under the Purchase Agreement. Proceeds received to date, and any additional proceeds from Fusion
Capital we receive under the common stock Purchase Agreement have been and will be used, together
with other funds available to us: (a) to manufacture vaccine supplies for our planned clinical
trials; (b) to provide technical support and other assistance to the HVTN during the conduct of our
planned Phase II clinical trial for a preventative HIV vaccine; (c) to plan and conduct a Phase II
clinical trial investigating the use of our vaccine as a therapeutic treatment for individuals
already infected with HIV; and (d) for working capital and general corporate purposes.
48
PLAN OF DISTRIBUTION
The common stock offered by this prospectus is being offered by Fusion Capital Fund II, LLC,
the selling stockholder (Fusion Capital). The common stock may be sold or distributed from time
to time by the selling stockholder directly to one or more purchasers or through brokers, dealers,
or underwriters who may act solely as agents at market prices prevailing at the time of sale, at
prices related to the prevailing market prices, at negotiated prices, or at fixed prices, which may
be changed. The sale of the common stock offered by this prospectus may be effected in one or more
of the following methods:
|
|
|
ordinary brokers transactions; |
|
|
|
|
transactions involving cross or block trades; |
|
|
|
|
through brokers, dealers, or underwriters who may act solely as agents; |
|
|
|
|
at the market into an existing market for the common stock such as the
over-the-counter bulletin board; |
|
|
|
|
in other ways not involving market makers or established business markets, including
direct sales to purchasers or sales effected through agents; |
|
|
|
|
in privately negotiated transactions; or |
|
|
|
|
any combination of the foregoing. |
In order to comply with the securities laws of certain states, if applicable, the shares may
be sold only through registered or licensed brokers or dealers. In addition, in certain states, the
shares may not be sold unless they have been registered or qualified for sale in the state or an
exemption from the registration or qualification requirement is available and complied with.
Brokers, dealers, underwriters, or agents participating in the distribution of the shares as
agents may receive compensation in the form of commissions, discounts, or concessions from the
selling stockholder and/or purchasers of the common stock for whom the broker-dealers may act as
agent. The compensation paid to a particular broker-dealer may be less than or in excess of
customary commissions.
Fusion Capital is an underwriter within the meaning of the Securities Act.
Neither we nor Fusion Capital can presently estimate the amount of compensation that any agent
will receive. We know of no existing arrangements between Fusion Capital, any other stockholder,
broker, dealer, underwriter, or agent relating to the sale or distribution of the shares offered by
this prospectus. At the time a particular offer of shares is made, a prospectus supplement, if
required, will be distributed that will set forth the names of any agents, underwriters, or dealers
and any compensation from the selling stockholder, and any other required information.
We will pay all of the expenses incident to the registration, offering, and sale of the shares
to the public other than commissions or discounts of underwriters, broker-dealers, or agents. We
have also agreed to indemnify Fusion Capital and related persons against specified liabilities,
including liabilities under the Securities Act.
Insofar as indemnification for liabilities arising under the Securities Act may be permitted
to our directors, officers, and controlling persons, we have been advised that in the opinion of
the SEC this indemnification is against public policy as expressed in the Securities Act and is
therefore, unenforceable.
Fusion Capital and its affiliates have agreed not to engage in any direct or indirect short
selling or hedging of our common stock during the term of the Purchase Agreement.
We have advised Fusion Capital that while it is engaged in a distribution of the shares
included in this prospectus it is required to comply with Regulation M promulgated under the
Securities Exchange Act of 1934, as amended. With certain exceptions, Regulation M precludes the
selling stockholder, any affiliated purchasers, and any broker-dealer or other person who
participates in
49
the distribution from bidding for or purchasing, or attempting to induce any person to bid for
or purchase any security which is the subject of the distribution until the entire distribution is
complete. Regulation M also prohibits any bids or purchases made in order to stabilize the price of
a security in connection with the distribution of that security. All of the foregoing may affect
the marketability of the shares offered hereby this prospectus.
This offering will terminate on the date that all shares offered by this prospectus have been
sold by Fusion Capital.
DESCRIPTION OF SECURITIES
The following description of our capital stock is summarized from, and qualified in its
entirety by reference to, our certificate of incorporation, which has been previously filed with
the SEC and is incorporated herein by reference. This summary is not intended to give full effect
to provisions of statutory or common law. We urge you to review the following documents because
they, and not this summary, define your rights as a holder of shares of common stock or preferred
stock:
|
|
|
The General Corporation Law of the State of Delaware (the DGCL), as it may be
amended from time to time; |
|
|
|
|
Our certificate of incorporation, as it may be amended or restated from time to time,
and |
|
|
|
|
Our bylaws, as they may be amended or restated from time to time. |
General
Our authorized capital stock consists of 910,000,000 shares, which are divided into two
classes consisting of 900,000,000 shares of common stock, par value $0.001 per share, and
10,000,000 shares of preferred stock, par value $0.01 per share. As of June 9, 2009, there were
issued and outstanding 752,564,992 shares of common stock, options to purchase 46,947,757 shares of
common stock and warrants to purchase 69,022,634 shares of common stock. No shares of preferred
stock were outstanding.
Common Stock
Holders of our common stock are entitled to one vote for each share held in the election of
directors and in all other matters to be voted on by the stockholders. There is no cumulative
voting in the election of directors. Holders of common stock are entitled to receive dividends as
may be declared from time to time by our Board of Directors out of funds legally available
therefor. In the event of liquidation, dissolution or winding up of the Company, holders of common
stock are to share in all assets remaining after the payment of liabilities. Holders of common
stock have no pre-emptive or conversion rights and are not subject to further calls or assessments.
There are no redemption or sinking fund provisions applicable to the common stock. The rights of
the holders of the common stock are subject to any rights that may be fixed for holders of
preferred stock. All of the outstanding shares of common stock are fully paid and non-assessable.
We issued new stock certificates, upon request, to stockholders of record upon the effective
date of the reincorporation merger and each issued and outstanding share of our common stock
immediately prior to the effective date of the merger evidenced ownership of the shares of common
stock of GeoVax after the effective date of the merger.
Preferred Stock
We are also authorized to issue 10,000,000 shares of preferred stock. Under our certificate of
incorporation, the Board of Directors has the power, without further action by the holders of
common stock, to designate the relative rights and preferences of the preferred stock, and issue
the preferred stock in one or more series as designated by the Board of Directors. The designation
of rights and preferences could include preferences as to liquidation, redemption and conversion
rights, voting rights, dividends or other preferences, any of which may be dilutive of the interest
of the holders of the common stock or the preferred stock of any other series. The ability of
directors, without stockholder approval, to issue additional shares of preferred stock could be
used as anti-takeover measures. Anti-takeover measures may result in you receiving less for your
stock than you otherwise might. The issuance of preferred stock creates additional securities with
dividend and liquidation preferences over common stock, and may have the effect of delaying or
preventing a change in control without further stockholder action and may adversely affect the
rights and powers, including voting rights, of the holders of common stock. In certain
circumstances, the issuance of preferred stock could depress the market price of the common stock.
50
Delaware anti-takeover law
We have elected not to be subject to certain provisions of Delaware law that could make it
more difficult to acquire us by means of a tender offer, a proxy contest, open market purchases,
removal of incumbent directors and otherwise. These provisions, summarized below, are expected to
discourage types of coercive takeover practices and inadequate takeover bids and to encourage
persons seeking to acquire control of us to first negotiate with us.
In general, Section 203 of the DGCL prohibits a publicly held Delaware corporation from
engaging in various business combination transactions with any interested stockholder for a
period of three years after the date of the transaction in which the person became an interested
stockholder, unless:
|
|
|
The transaction is approved by the board of directors prior to the date the
interested stockholder obtained interested stockholder status; |
|
|
|
|
Upon consummation of the transaction that resulted in the stockholders becoming an
interested stockholder, the stockholder owned at least 85% of the voting stock of the
corporation outstanding at the time the transaction commenced, excluding for purposes of
determining the number of shares outstanding those shares owned by (a) persons who are
directors and also officers and (b) employee stock plans in which employee participants
do not have the right to determine confidentially whether shares held subject to the
plan will be tendered in a tender or exchange offer; or |
|
|
|
|
On or subsequent to the date the business combination is approved by the board of
directors and authorized at an annual or special meeting of stockholders by the
affirmative vote of at least 66 2/3% of the outstanding voting stock that is not owned
by the interested stockholder. |
A business combination is defined to include mergers, asset sales and other transactions
resulting in financial benefit to a stockholder. In general, an interested stockholder is a
person who, together with affiliates and associates, owns or within three years, did own, 15% or
more of a corporations voting stock.
Section 203 applies to Delaware corporations that have a class of voting stock that is listed
on a national securities exchange or held of record by more than 2,000 stockholders; provided,
however, the restrictions of this statute will not apply to a corporation if:
|
|
|
the corporations original charter contains a provision expressly electing not to be
governed by the statute, |
|
|
|
|
the Board of Directors adopts an amendment to the corporations bylaws within 90 days
of the effective date of the statute expressly electing not to be governed by it, |
|
|
|
|
the stockholders of the corporation adopt an amendment to its charter or bylaws
expressly electing not to be governed by the statute (so long as such amendment is
approved by the affirmative vote of a majority of the shares entitled to vote), |
|
|
|
|
a stockholder becomes an interested stockholder inadvertently and as soon as
practicable divests himself of ownership of sufficient shares so that he ceases to be an
interested stockholder and during the three year period immediately prior to a business
combination would not have been an interested stockholder but for the inadvertent
acquisition, |
|
|
|
|
the business combination is proposed prior to the consummation or abandonment of a
merger or consolidation, a sale, lease, exchange, mortgage, pledge, transfer or other
disposition of assets of the corporation or a proposed tender or exchange offer for 50%
or more of the outstanding voting shares of the corporation, or |
|
|
|
|
the business combination is with an interested stockholder who became an interested
stockholder at a time when the restrictions contained in the statutes did not apply. |
Our certificate of incorporation includes a provision electing not to be governed by Section 203 of
the DCGL. Accordingly, our Board of Directors does not have the power to reject certain business
combinations with interested stockholders based on Section 203 of the DCGL.
51
WHERE YOU CAN FIND MORE INFORMATION
We are subject to the informational reporting requirements of the Exchange Act, which requires
us to file annual, quarterly, and current reports, proxy statements and other information with the
SEC. The SEC maintains an Internet site that contains such information regarding issuers that file
electronically, such as GeoVax Labs, Inc. The public may inspect our filings over the Internet at
the SECs home page at www.sec.gov . The public may also read and copy any document we
file at the Public Reference Room of the SEC at 100 F Street, N.E., Washington, DC 20549.
Information on the operation of the Public Reference Room may be obtained by the public by calling
the SEC at 1-800-SEC-0330.
EXPERTS
The audited consolidated financial statements of GeoVax, Labs, Inc. and subsidiary for the
years ended December 31, 2008, 2007 and 2006 and for the period of time considered part of the
development stage from January 1, 2006 to December 31, 2008, included in the Registration Statement
have been audited by Porter Keadle Moore LLP, an independent registered public accounting firm, as
set forth in its report appearing herein. Such financial statements have been so included in
reliance upon the reports of such firm given upon its authority as an expert in accounting and
auditing.
LEGAL MATTERS
The validity of the shares of our common stock offered by the selling stockholder has been
passed upon by the law firm of Womble Carlyle Sandridge & Rice, PLLC, Atlanta, Georgia.
52
GEOVAX LABS, INC.
(A DEVELOPMENT-STAGE ENTERPRISE)
INDEX TO 2008 CONSOLIDATED FINANCIAL STATEMENTS
|
|
|
|
|
Years Ended 2008, 2007 and 2006 and the Period from Inception (June 27, 2001) to December 31, 2008 |
|
|
|
|
|
|
|
|
|
|
|
|
F- 2 |
|
|
|
|
F- 3 |
|
|
|
|
F- 4 |
|
|
|
|
F- 5 |
|
|
|
|
F- 6 |
|
|
|
|
F- 7 |
|
|
|
|
F- 20 |
|
|
|
|
|
|
Three Months Ended March 31, 2009 and 2008 and the Period from Inception (June 27, 2001) to
March 31, 2009 (unaudited) |
|
|
|
|
|
|
|
|
|
|
|
|
F-21 |
|
|
|
|
|
|
|
|
|
F-22 |
|
|
|
|
|
|
|
|
|
F-23 |
|
|
|
|
|
|
|
|
|
F-25 |
|
|
|
|
|
|
|
|
|
F-26 |
|
F-1
REPORT OF
INDEPENDENT REGISTERED PUBLIC ACCOUNTING FIRM
ON FINANCIAL STATEMENTS
To the Board of Directors
GeoVax Labs, Inc.
Atlanta, Georgia
We have audited the accompanying consolidated balance sheet of
GeoVax Labs, Inc. and subsidiary (a development stage company)
(the Company) as of December 31, 2008 and 2007,
and the related consolidated statements of operations,
stockholders equity, and cash flows for each of the three
years in the period ended December 31, 2008, and for the
period of time considered part of the development stage from
January 1, 2006 to December 31, 2008, except we did
not audit the Companys financial statements for the period
from June 27, 2001 to December 31, 2005 which were
audited by other auditors. These financial statements are the
responsibility of the Companys management. Our
responsibility is to express an opinion on these financial
statements based on our audit.
We conducted our audits 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 audits provide a
reasonable basis for our opinion.
In our opinion, the consolidated financial statements referred
to above present fairly, in all material respects, the financial
position of GeoVax Labs, Inc. and subsidiary as of
December 31, 2008 and 2007, and the results of their
operations and their cash flows for each of the three years in
the period ended December 31, 2008 in conformity with
accounting principles generally accepted in the United States of
America.
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 Companys
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.
We have also audited, in accordance with the standards of the
Public Company Accounting Oversight Board (United States),
GeoVax Labs, Inc. and subsidiarys internal control over
financial reporting as of December 31, 2008, based on
criteria established in Internal Control
Integrated Framework issued by the Committee of Sponsoring
Organizations of the Treadway Commission (COSO) and our report
dated March 5, 2009, expressed an unqualified opinion on
the effectiveness of GeoVax Labs, Inc.s internal control
over financial reporting.
/s/ PORTER
KEADLE MOORE LLP
Atlanta, Georgia
March 5, 2009
F-2
GEOVAX
LABS, INC.
(A DEVELOPMENT-STAGE ENTERPRISE)
CONSOLIDATED BALANCE SHEETS
|
|
|
|
|
|
|
|
|
|
|
December 31,
|
|
|
|
2008
|
|
|
2007
|
|
|
ASSETS
|
Current assets:
|
|
|
|
|
|
|
|
|
Cash and cash equivalents
|
|
$
|
2,191,180
|
|
|
$
|
1,990,356
|
|
Grant funds receivable
|
|
|
311,368
|
|
|
|
93,260
|
|
Stock subscriptions receivable
|
|
|
|
|
|
|
897,450
|
|
Prepaid expenses and other
|
|
|
299,286
|
|
|
|
49,748
|
|
|
|
|
|
|
|
|
|
|
Total current assets
|
|
|
2,801,834
|
|
|
|
3,030,814
|
|
Property and equipment, net of accumulated depreciation of
$112,795 and $76,667 at December 31, 2008 and 2007,
respectively
|
|
|
138,847
|
|
|
|
75,144
|
|
Other assets:
|
|
|
|
|
|
|
|
|
Licenses, net of accumulated amortization of $134,276 and
$109,390 at December 31, 2008 and 2007, respectively
|
|
|
114,580
|
|
|
|
139,466
|
|
Deposits
|
|
|
980
|
|
|
|
980
|
|
|
|
|
|
|
|
|
|
|
Total other assets
|
|
|
115,560
|
|
|
|
140,446
|
|
|
|
|
|
|
|
|
|
|
Total assets
|
|
$
|
3,056,241
|
|
|
$
|
3,246,404
|
|
|
|
|
|
|
|
|
|
|
|
LIABILITIES AND STOCKHOLDERS EQUITY
|
Current liabilities:
|
|
|
|
|
|
|
|
|
Accounts payable and accrued expenses
|
|
$
|
176,260
|
|
|
$
|
390,993
|
|
Amounts payable to related parties
|
|
|
170,162
|
|
|
|
156,225
|
|
Accrued salaries
|
|
|
|
|
|
|
51,320
|
|
|
|
|
|
|
|
|
|
|
Total current liabilities
|
|
|
346,422
|
|
|
|
598,538
|
|
Commitments (Note 5)
|
|
|
|
|
|
|
|
|
Stockholders equity:
|
|
|
|
|
|
|
|
|
Common stock, $.001 par value, 900,000,000 shares
authorized 747,448,876 and 731,627,926 shares outstanding
at December 31, 2008 and 2007, respectively
|
|
|
747,449
|
|
|
|
731,628
|
|
Additional paid-in capital
|
|
|
16,215,966
|
|
|
|
12,441,647
|
|
Deficit accumulated during the development stage
|
|
|
(14,253,596
|
)
|
|
|
(10,525,409
|
)
|
|
|
|
|
|
|
|
|
|
Total stockholders equity
|
|
|
2,709,819
|
|
|
|
2,647,866
|
|
|
|
|
|
|
|
|
|
|
Total liabilities and stockholders equity
|
|
$
|
3,056,241
|
|
|
$
|
3,246,404
|
|
|
|
|
|
|
|
|
|
|
See accompanying report of independent registered public
accounting firm and notes to financial statements.
F-3
GEOVAX
LABS. INC.
(A DEVELOPMENT-STAGE ENTERPRISE)
CONSOLIDATED STATEMENTS OF OPERATIONS
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
From Inception
|
|
|
|
Years Ended December 31,
|
|
|
(June 27, 2001) to
|
|
|
|
2008
|
|
|
2007
|
|
|
2006
|
|
|
December 31, 2008
|
|
|
Grant revenue
|
|
$
|
2,910,170
|
|
|
$
|
237,004
|
|
|
$
|
852,905
|
|
|
$
|
6,558,355
|
|
Operating expenses:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Research and development
|
|
|
3,741,489
|
|
|
|
1,757,125
|
|
|
|
665,863
|
|
|
|
12,491,663
|
|
General and administrative
|
|
|
2,970,068
|
|
|
|
2,784,182
|
|
|
|
843,335
|
|
|
|
8,598,125
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
6,711,557
|
|
|
|
4,541,307
|
|
|
|
1,509,198
|
|
|
|
21,089,788
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Loss from operations
|
|
|
(3,801,387
|
)
|
|
|
(4,304,303
|
)
|
|
|
(656,293
|
)
|
|
|
(14,531,433
|
)
|
Other income (expense):
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Interest income
|
|
|
73,200
|
|
|
|
62,507
|
|
|
|
72,127
|
|
|
|
283,506
|
|
Interest expense
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(5,669
|
)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
73,200
|
|
|
|
62,507
|
|
|
|
72,127
|
|
|
|
277,837
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net loss
|
|
$
|
(3,728,187
|
)
|
|
$
|
(4,241,796
|
)
|
|
$
|
(584,166
|
)
|
|
$
|
(14,253,596
|
)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Basic and diluted:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Loss per common share
|
|
$
|
(0.01
|
)
|
|
$
|
(0.01
|
)
|
|
$
|
(0.00
|
)
|
|
$
|
(0.03
|
)
|
Weighted average shares
|
|
|
740,143,397
|
|
|
|
714,102,311
|
|
|
|
414,919,141
|
|
|
|
425,026,119
|
|
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 STOCKHOLDERS
EQUITY (DEFICIENCY)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Deficit
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Accumulated
|
|
|
Total
|
|
|
|
|
|
|
|
|
|
|
|
|
Stock
|
|
|
during the
|
|
|
Stockholders
|
|
|
|
Common Stock
|
|
|
Additional
|
|
|
Subscription
|
|
|
Development
|
|
|
Equity
|
|
|
|
Shares
|
|
|
Amount
|
|
|
Paid In 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 preferred stock to common stock
|
|
|
177,542,538
|
|
|
|
177,543
|
|
|
|
897,573
|
|
|
|
|
|
|
|
|
|
|
|
1,075,116
|
|
Common stock issued in connection with merger
|
|
|
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
|
|
Sale of common stock for cash
|
|
|
20,336,433
|
|
|
|
20,336
|
|
|
|
3,142,614
|
|
|
|
|
|
|
|
|
|
|
|
3,162,950
|
|
Issuance of common stock upon stock option exercise
|
|
|
123,550
|
|
|
|
124
|
|
|
|
4,876
|
|
|
|
|
|
|
|
|
|
|
|
5,000
|
|
Stock-based compensation expense
|
|
|
|
|
|
|
|
|
|
|
1,518,496
|
|
|
|
|
|
|
|
|
|
|
|
1,518,496
|
|
Net loss for the year ended December 31, 2007
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(4,241,796
|
)
|
|
|
(4,241,796
|
)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Balance at December 31, 2007
|
|
|
731,627,926
|
|
|
|
731,628
|
|
|
|
12,441,647
|
|
|
|
|
|
|
|
(10,525,409
|
)
|
|
|
2,647,866
|
|
Sale of common stock for cash in private placement transactions
|
|
|
8,806,449
|
|
|
|
8,806
|
|
|
|
1,356,194
|
|
|
|
|
|
|
|
|
|
|
|
1,365,000
|
|
Transactions related to common stock purchase agreement with
Fusion Capital
|
|
|
6,514,501
|
|
|
|
6,515
|
|
|
|
399,576
|
|
|
|
|
|
|
|
|
|
|
|
406,091
|
|
Stock-based compensation:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Stock options
|
|
|
|
|
|
|
|
|
|
|
1,798,169
|
|
|
|
|
|
|
|
|
|
|
|
1,798,169
|
|
Consultant warrants
|
|
|
|
|
|
|
|
|
|
|
146,880
|
|
|
|
|
|
|
|
|
|
|
|
146,880
|
|
Issuance of common stock for consulting services
|
|
|
500,000
|
|
|
|
500
|
|
|
|
73,500
|
|
|
|
|
|
|
|
|
|
|
|
74,000
|
|
Net loss for the year ended December 31, 2008
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(3,728,187
|
)
|
|
|
(3,728,187
|
)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Balance at December 31, 2008
|
|
|
747,448,876
|
|
|
$
|
747,449
|
|
|
$
|
16,215,966
|
|
|
$
|
|
|
|
$
|
(14,253,596
|
)
|
|
$
|
2,709,819
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
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 CASH FLOWS
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
From Inception
|
|
|
|
Years Ended December 31,
|
|
|
(June 27, 2001) to
|
|
|
|
2008
|
|
|
2007
|
|
|
2006
|
|
|
December 31, 2008
|
|
|
Cash flows from operating activities:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net loss
|
|
$
|
(3,728,187
|
)
|
|
$
|
(4,241,796
|
)
|
|
$
|
(584,166
|
)
|
|
$
|
(14,253,596
|
)
|
Adjustments to reconcile net loss to net cash used in operating
activities
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Depreciation and amortization
|
|
|
61,014
|
|
|
|
54,461
|
|
|
|
49,095
|
|
|
|
247,071
|
|
Accretion of preferred stock redemption value
|
|
|
|
|
|
|
|
|
|
|
58,561
|
|
|
|
346,673
|
|
Stock-based compensation expense
|
|
|
2,019,049
|
|
|
|
1,518,496
|
|
|
|
|
|
|
|
3,537,545
|
|
Changes in assets and liabilities
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Grant funds receivable
|
|
|
(218,108
|
)
|
|
|
(93,260
|
)
|
|
|
|
|
|
|
(311,368
|
)
|
Stock subscriptions receivable
|
|
|
|
|
|
|
(897,450
|
)
|
|
|
|
|
|
|
|
|
Prepaid expenses and other current assets
|
|
|
(249,538
|
)
|
|
|
(11,618
|
)
|
|
|
124,701
|
|
|
|
(299,286
|
)
|
Deposits
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(980
|
)
|
Accounts payable and accrued expenses
|
|
|
(252,116
|
)
|
|
|
405,424
|
|
|
|
(123,227
|
)
|
|
|
346,422
|
|
Unearned grant revenue
|
|
|
|
|
|
|
|
|
|
|
(852,905
|
)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total adjustments
|
|
|
1,360,301
|
|
|
|
976,053
|
|
|
|
(743,775
|
)
|
|
|
3,866,077
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net cash used in operating activities
|
|
|
(2,367,886
|
)
|
|
|
(3,265,743
|
)
|
|
|
(1,327,941
|
)
|
|
|
(10,387,519
|
)
|
Cash flows from investing activities:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Purchase of property and equipment
|
|
|
(99,831
|
)
|
|
|
|
|
|
|
(69,466
|
)
|
|
|
(251,642
|
)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net cash used in investing activities
|
|
|
(99,831
|
)
|
|
|
|
|
|
|
(69,466
|
)
|
|
|
(251,642
|
)
|
Cash flows from financing activities:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net proceeds from sale of common stock
|
|
|
2,668,541
|
|
|
|
3,162,950
|
|
|
|
2,212,849
|
|
|
|
12,096,898
|
|
Net proceeds from exercise of stock options
|
|
|
|
|
|
|
5,000
|
|
|
|
|
|
|
|
5,000
|
|
Net proceeds from sale of preferred stock
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
728,443
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net cash provided by financing activities
|
|
|
2,668,541
|
|
|
|
3,167,950
|
|
|
|
2,212,849
|
|
|
|
12,830,341
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net increase (decrease) in cash and cash equivalents
|
|
|
200,824
|
|
|
|
(97,793
|
)
|
|
|
815,442
|
|
|
|
2,191,180
|
|
Cash and cash equivalents at beginning of period
|
|
|
1,990,356
|
|
|
|
2,088,149
|
|
|
|
1,272,707
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Cash and cash equivalents at end of period
|
|
$
|
2,191,180
|
|
|
$
|
1,990,356
|
|
|
$
|
2,088,149
|
|
|
$
|
2,191,180
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Supplemental disclosure of cash flow information Interest paid
|
|
$
|
|
|
|
$
|
|
|
|
$
|
|
|
|
$
|
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 Companys 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-6
GEOVAX
LABS, INC.
(A DEVELOPMENT-STAGE ENTERPRISE)
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS
Years Ended December 31, 2008, 2007 and 2006 and
Period from Inception (June 27, 2001) to
December 31, 2008
GeoVax Labs, Inc. (GeoVax or the
Company), is a development stage biotechnology
company focused on developing human vaccines for diseases caused
by Human Immunodeficiency Virus (HIV) and other infectious
agents. As discussed in Note 3, the Company has exclusively
licensed from Emory University vaccine technology which was
developed in collaboration with the National Institutes of
Health (NIH) and the Centers for Disease Control and Prevention
(CDC).
The Company was originally incorporated in June 1988 under the
laws of Illinois as Dauphin Technology, Inc.
(Dauphin). Dauphin was unsuccessful and its
operations were terminated in December 2003. In September 2006,
Dauphin completed a merger (the Merger) with GeoVax,
Inc. which was incorporated under the laws of Georgia in June
2001 (date of inception). 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 does not conduct
any business other than GeoVax, Inc.s business of
developing human vaccines. The Merger was accounted for under
the purchase method of accounting as a reverse acquisition in
accordance with U.S. generally accepted accounting
principles. Under this method of accounting, Dauphin was treated
as the acquired company and, accordingly, all financial
information prior to the date of Merger presented in the
accompanying condensed consolidated financial statements, or in
the notes herein, as well as any references to prior operations,
are those of GeoVax, Inc. In June 2008, the Company was
reincorporated under the laws of the State of Delaware.
The Company is devoting all of its present efforts to research
and development. We have funded our activities to date almost
exclusively from equity financings and government grants, and we
will continue to require substantial funds to continue these
activities.
In September 2007, the National Institutes of Health awarded the
Company a grant of approximately $15 million (approximately
$3 million awarded annually) to be funded over a
5 year period (see Note 4). And in May 2008, we
entered into a $10 million common stock purchase agreement
with a third party institutional fund (see
Note 7) which we are presently utilizing to meet our
additional cash needs, there is currently approximately
$9.4 million remaining in undrawn funds pursuant to this
arrangement. We expect that the proceeds from the NIH grant,
combined with our existing cash resources and our anticipated
use of the common stock purchase agreement, will be sufficient
to fund our planned activities through 2009 and into 2010. The
extent to which we rely on the common stock purchase agreement
as a source of funding will depend on a number of factors
including the prevailing market price of our common stock and
the extent to which we can secure working capital from other
sources if we choose to seek such other sources.
While we believe that we will be successful in obtaining the
necessary financing to fund our operations through the
aforementioned financing arrangement or through other sources,
the Companys ability to succeed in its operations is
ultimately dependent upon management of our cash resources,
successful development of our product candidates, entering into
licensing, collaboration or partnership agreements, execution of
future financings or transactions and ultimately, upon
achievement of positive cash flow from operations. There can be
no assurance that additional funds will be available on terms
acceptable to the Company or that the Company will ever become
profitable.
F-7
GEOVAX
LABS, INC.
(A DEVELOPMENT-STAGE ENTERPRISE)
NOTES TO CONSOLIDATED FINANCIAL
STATEMENTS (Continued)
|
|
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
(June 27, 2001) have been considered as part of the
Companys 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.
Cash
and Cash Equivalents
We consider all highly liquid investments with a maturity of
three months or less when purchased to be cash equivalents. Our
cash and cash equivalents consist primarily of bank deposits and
high yield money market accounts. The recorded values
approximate fair market values due to the short maturities.
Fair
Value of Financial Instruments and Concentration of Credit
Risk
Financial instruments that subject us to concentration of credit
risk consist primarily of cash and cash equivalents, which are
maintained by a high credit quality financial institution. The
carrying values reported in the balance sheets for cash and cash
equivalents approximate fair values.
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 $36,128, $29,575 and $24,210 during the
years ended December 31, 2008, 2007 and 2006, respectively.
Other
Assets
Other assets consist principally of license agreements for the
use of technology obtained through the issuance of the
Companys common stock. These license agreements are
amortized on a straight line basis over ten years. Amortization
expense related to these agreements was $24,886 during each of
the years ended December 31, 2008, 2007 and 2006,
respectively, and is expected to be $24,886, $24,886, $24,886,
$19,923 and $10,000 for each of the next five years,
respectively.
F-8
GEOVAX
LABS, INC.
(A DEVELOPMENT-STAGE ENTERPRISE)
NOTES TO CONSOLIDATED FINANCIAL
STATEMENTS (Continued)
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.
Accrued
Liabilities
As part of the process of preparing our financial statements, we
estimate expenses that we believe we have incurred, but have not
yet been billed by our third party vendors. This process
involves identifying services and activities that have been
performed by such vendors on our behalf and estimating the level
to which they have been performed and the associated cost
incurred for such service as of each balance sheet date in our
financial statements. Examples of expenses for which we accrue
include fees for professional services and fees owed to contract
manufacturers in conjunction with the manufacture of vaccines
for our clinical trials. We make these estimates based upon
progress of activities related to contractual obligations and
information received from vendors.
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 2006 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. All
common share equivalents (which 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: 114,829,102; 93,637,594; and
56,431,032 shares at December 31, 2008, 2007 and 2006,
respectively.
Revenue
Recognition
We recognize revenue in accordance with the SECs Staff
Accounting Bulletin No. 101, Revenue Recognition in
Financial Statements, as amended by Staff Accounting
Bulletin No. 104, Revenue Recognition,
(SAB 104). SAB 104 provides guidance
in applying U.S. generally accepted accounting principles
to revenue recognition issues, and specifically addresses
revenue recognition for upfront, nonrefundable fees received in
connection with research collaboration agreements. During 2008
and 2007, our revenue consisted of government grant revenue
received directly from the National Institutes of Health (see
Note 4); in prior years our revenue consisted of grant
revenue subcontracted to us from Emory University pursuant to
collaborative arrangements. Revenue from these arrangements is
approximately equal to the costs incurred and is recorded as
income as the related costs are incurred.
Research
and Development Expense
Research and development expense primarily consists of costs
incurred in the discovery, development, testing and
manufacturing of the Companys product candidates. These
expenses consist primarily of (i) fees
F-9
GEOVAX
LABS, INC.
(A DEVELOPMENT-STAGE ENTERPRISE)
NOTES TO CONSOLIDATED FINANCIAL
STATEMENTS (Continued)
paid to third-party service providers to perform, monitor and
accumulate data related to the Companys preclinical
studies and clinical trials, (ii) costs related to
sponsored research agreements, (iii) the costs to procure
and manufacture materials used in clinical trials,
(iv) laboratory supplies and facility-related expenses to
conduct development, and (v) salaries, benefits, and
share-based compensation for personnel. These costs are charged
to expense as incurred.
Patent
Costs
Our expenditures relating to obtaining and protecting patents
are charged to expense when incurred, and are included in
general and administrative expense.
Period
to Period Comparisons
Our 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
We account 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, we adopted Financial Accounting
Standards Board (FASB) Statement of Financial
Accounting Standards No. 123 (revised 2004), Share-Based
Payments (SFAS 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 123R replaces
SFAS 123, Accounting for Stock-Based Compensation
(SFAS 123), and supersedes Accounting
Principles Board (APB) Opinion No. 25,
Accounting for Stock Issued to Employees. We adopted
SFAS 123R using the prospective application method which
requires us to apply the provisions of SFAS 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 123R and expensed on a straight
line basis over the service periods of each award. See
Note 7 for additional stock-based compensation information.
Recent
Accounting Pronouncements
Effective January 1, 2008, we adopted FASB Statement of
Financial Accounting Standards No. 157, Fair Value
Measurements (SFAS 157). SFAS 157
provides enhanced guidance for using fair value to measure
assets and liabilities. SFAS 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 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. In
February 2008, the FASB issued Staff Position
No. 157-2,
(FSP 157-2)
which delayed the January 1, 2008 effective date of
SFAS 157 for all nonfinancial assets and nonfinancial
liabilities, except those already being recognized or disclosed
at fair value in the financial
F-10
GEOVAX
LABS, INC.
(A DEVELOPMENT-STAGE ENTERPRISE)
NOTES TO CONSOLIDATED FINANCIAL
STATEMENTS (Continued)
statements on a recurring basis (at least annually), until
January 1, 2009. Implementation of these standards had no
impact on our results of operations, financial position, or cash
flows.
Effective January 1, 2008, we adopted FASB Statement of
Financial Accounting Standards No. 159, The Fair
Value Option for Financial Assets and Financial
Liabilities (SFAS 159). SFAS 159
permits entities to choose to measure many financial instruments
and certain other items at fair value and report unrealized
gains and losses in earnings. Such accounting is optional and is
generally to be applied instrument by instrument. We currently
have no instruments for which we are applying the fair value
accounting option provided by SFAS 159, therefore the
adoption of SFAS 159 had no impact on our results of
operations, financial position, or cash flows.
Effective January 1, 2008, we adopted FASB Emerging Issues
Task Force Issue
No. 07-3,
Accounting for Nonrefundable Advance Payments for Goods
or Services to Be Used in Future Research and Development
Activities
(EITF 07-3).
EITF
No. 07-3
addresses the diversity that exists with respect to the
accounting for the non-refundable portion of a payment made by a
research and development entity for future research and
development activities. Under
EITF 07-3,
an entity would defer and capitalize non-refundable advance
payments made for research and development activities until the
related goods are delivered or the related services are
performed. The adoption of
EITF 07-3
did not have a material impact on our results of operations,
financial position, or cash flows.
In March 2008, the FASB issued Statement of Financial Accounting
Standards No. 161, Disclosures about Derivative
Instruments and Hedging Activities
(SFAS 161). SFAS 161 amends and expands
the disclosure requirements of SFAS 133,
Accounting for Derivative Instruments and
Hedging. SFAS 161 is effective for fiscal years
beginning after November 15, 2008. We will adopt
SFAS 161 in the first quarter of 2009 and currently expect
such adoption to have no impact on our results of operations,
financial position, or cash flows.
In April 2008, the FASB issued Staff Position
No. 142-3,
Determination of the Useful Life of Intangible
Assets
(FSP 142-3).
FSP 142-3
amends the factors that should be considered in developing
renewal or extension assumptions used to determine the useful
life of a recognized intangible asset under FASB Statement of
Financial Accounting Standards No. 142, Goodwill
and Other Intangible Assets.
FSP 142-3
will be effective for us in the first quarter of 2009. We are
currently assessing the impact of
FSP 142-3
on our financial statements.
In May 2008, the FASB issued Statement of Financial Accounting
Standards No. 162, The Hierarchy of Generally
Accepted Accounting Principles
(SFAS 162). SFAS 162 identifies the
sources of accounting principles and the framework for selecting
the principles to be used in the preparation of financial
statements of nongovernmental entities that are presented in
conformity with generally accepted accounting principles in the
United States. SFAS 162 will become effective 60 days
following Securities and Exchange Commission (SEC)
approval of the Public Company Accounting Oversight Board
(PCAOB) amendments to AU Section 411, The Meaning
of Present Fairly in Conformity With Generally Accepted
Accounting Principles. We do not anticipate the
adoption of SFAS 162 will have a material impact on our
results of operations, financial position, or cash flows.
In June 2008, the FASB issued Staff Position
No. EITF 03-6-1,
Determining Whether Instruments Granted in Share-Based
Payment Transactions Are Participating Securities
(EITF 03-6-1).
EITF 03-6-1
addresses whether instruments granted in share-based payment
transactions are participating securities prior to vesting, and
therefore, need to be included in the earnings allocation in
calculating earnings per share under the two-class method
described in FASB Statement of Financial Accounting Standards
No. 128, Earnings per Share.
EITF 03-6-1
requires companies to treat unvested share-based payment awards
that have
non-forfeitable
rights to dividend or dividend equivalents as a separate class
of securities in calculating
F-11
GEOVAX
LABS, INC.
(A DEVELOPMENT-STAGE ENTERPRISE)
NOTES TO CONSOLIDATED FINANCIAL
STATEMENTS (Continued)
earnings per share.
EITF 03-6-1
will be effective for us in the first quarter of 2009. We do not
expect that such adoption will have a material, if any, effect
on our results of operations, financial position, or cash flows.
We do not believe that any other recently issued, but not yet
effective, accounting standards if currently adopted would have
a material effect on our financial statements.
Emory License During 2002, we 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 us in
exchange for 35,226,695 shares of our common stock valued
at $148,856. The Emory License expires on the date of the latest
expiration date of the underlying patents. The Emory License,
among other contractual obligations, requires payments based on
milestone achievements, royalties on our sales or on payments to
us by our sublicensees, and payment of maintenance fees in the
event certain milestones are not met within the time periods
specified in the agreement.
MFD License During 2004, we entered into a
license agreement with MFD, Inc. in exchange for
2,470,998 shares of our common stock valued at $100,000.
Pursuant to this agreement, we obtained a fully paid, worldwide,
irrevocable exclusive license to certain patents covering
technology that may be employed by our products.
In September 2007, the National Institutes of Health (NIH)
awarded us an Integrated Preclinical/Clinical AIDS Vaccine
Development (IPCAVD) grant to support our HIV/AIDS vaccine
program. The project period for the grant, which is renewable
annually, covers a five year period which commenced October
2007, with an expected annual award of approximately
$3 million per year, or $15 million in the aggregate.
We are utilizing this funding to further our HIV/AIDS vaccine
development, optimization, production and human clinical trial
testing. We record revenue associated with the grant as the
related costs and expenses are incurred. During 2008 and 2007,
we recorded $2,910,170 and $237,004, respectively, of revenue
associated with the grant.
Leases We lease the office and laboratory
space used for our 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. We also share the lease
expense for office space in the Chicago area for one of our
officers /directors, but we are not obligated under any lease
agreement for such space. Rent expense totaled $71,041, $56,588
and $38,921 for the years ended December 31, 2008, 2007 and
2006, respectively.
Manufacturing Contracts At December 31,
2008, there are approximately $203,000 of unrecorded contractual
commitments associated with our vaccine manufacturing
activities, for services expected to be rendered to us during
2009.
Vivalis Letter of Intent In July 2008, we
signed a non-binding letter of intent for a proposed license and
development agreement for the use of vaccine manufacturing
technology owned by Vivalis S.A., a French biopharmaceutical
company. Subsequent to the signing of the letter of intent, we
paid a signing fee of approximately $241,000 to Vivalis
(recorded as a Prepaid Expense in the accompanying Consolidated
Balance Sheet) and, upon execution of the final license
agreement, we will incur a commitment of approximately $900,000
as our contribution to the development effort, expected to be
incurred during the remainder of 2009 and early 2010. As the
development milestone fees are denominated in Euros, this
estimate of our financial commitment is based on current
exchange rates; the actual amounts will be greater or lesser,
depending on the actual exchange rates at the time of each
milestone achievement.
F-12
GEOVAX
LABS, INC.
(A DEVELOPMENT-STAGE ENTERPRISE)
NOTES TO CONSOLIDATED FINANCIAL
STATEMENTS (Continued)
|
|
6.
|
2006
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,
Dauphins 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
Companys 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 Companys
708,326,669 shares of common stock then outstanding.
We accounted for the Merger 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.
Common
Stock Transactions
In January 2007, we sold 1,543,210 shares of our common
stock to two individual accredited investors for an aggregate
purchase price of $250,000. We also issued to the investors
warrants to purchase an aggregate of 771,605 shares of
common stock at a price of $0.75 per share, expiring on
December 31, 2009.
In January 2007, we issued 123,550 shares of our common
stock to a former employee for an aggregate purchase price of
$5,000, pursuant to the exercise of stock options.
In July 2007, we entered into a Subscription Agreement with an
institutional investor (the Investor), pursuant to
which we agreed to sell shares of our common stock at a price of
$0.155 per share for an aggregate purchase price of $7,500,000.
The transaction was to be consummated in two closings, during
August and November. We also agreed to issue to the Investor a
3 year stock purchase warrant to purchase shares of our
common stock at an exercise price of $0.33 per share. In
September 2007, the Investor advanced $300,000 to us as payment
towards its obligation associated with the first closing, but
defaulted on its remaining obligation. In December 2007, we
settled with the Investor through the issuance of a pro rata
portion of the shares (1,935,484 shares) and warrants
(1,571,429 warrants) which would have been issued upon the first
closing, in exchange for the $300,000 advanced to us.
In November and December 2007, we sold an aggregate of
16,857,739 shares of our common stock to twenty-six
individual accredited investors for an aggregate purchase price
of $2,612,950. We also issued to the investors warrants to
purchase an aggregate of 26,733,470 shares of common stock
at a price of $0.33 per share, 15,096,774 of which expire in
December 2012, with the remainder expiring in November/December
2011.
F-13
GEOVAX
LABS, INC.
(A DEVELOPMENT-STAGE ENTERPRISE)
NOTES TO CONSOLIDATED FINANCIAL
STATEMENTS (Continued)
In January 2008, we entered into an agreement with a third party
consultant for investor relations and financial consulting
services which provided for the issuance during 2008 of an
aggregate of 500,000 shares of our common stock. During
2008 we recorded general and administrative expense of $74,000
related to the issuance of our common stock pursuant to this
arrangement. We also issued a warrant to purchase a total of
2,700,000 shares of our common stock at an exercise price
of $0.33 per share, which expires in December 2011. (see
Compensatory Warrants below in this footnote). Concurrent
with the execution of this agreement, we terminated a prior
agreement with the consultant, resulting in the cancellation of
2,700,000 of the previously issued warrants.
During April and May 2008, we sold an aggregate of
8,806,449 shares of our common stock to 16 individual
accredited investors for an aggregate purchase price of
$1,365,000. We also issued to the investors warrants to purchase
an aggregate of 14,104,841 shares of common stock at a
price of $0.33 per share, 8,258,065 of which expire in May 2013,
with the remainder expiring in April/May 2012.
Common
Stock Purchase Agreement
In May 2008, we signed a common stock purchase agreement (the
Purchase Agreement) with Fusion Capital
Fund II, LLC (Fusion). The Purchase Agreement
allows us to require Fusion to purchase up to $10 million
of our common stock in amounts ranging from $80,000 to
$1.0 million per purchase transaction, depending on certain
conditions, from time to time over a
25-month
period beginning July 1, 2008, the date on which the SEC
declared effective the registration statement related to the
transaction.
The purchase price of the shares relating to the
$10 million of future funding will be based on the
prevailing market prices of our shares at the times of the sales
without any fixed discount, and we will control the timing and
amounts of any sales of shares to Fusion. Fusion does not have
the right or the obligation to purchase any shares of our common
stock on any business day that the purchase price of our common
stock is below $0.05 per share. The Purchase Agreement may be
terminated by us at any time at our discretion without any
additional cost to us. There are no negative covenants,
restrictions on future financings, penalties or liquidated
damages in the agreement.
In consideration for entering into the Purchase Agreement, and
upon the execution of the Purchase Agreement we issued to Fusion
2,480,510 shares of our common stock as a commitment fee,
and we agreed to issue to Fusion up to an additional 2,480,510
commitment fee shares, on a pro rata basis, as we receive the
$10 million of future funding. We also issued
200,000 shares of our common stock to Fusion (together with
a nominal cash advance) as reimbursement for due diligence
expenses. At that time we reserved a total of 37,480,510 of our
authorized but unissued shares, in the aggregate, for issuance
pursuant to the Purchase Agreement (including the 2,480,510
unissued commitment fee shares). The aggregate value of the
commitment fee shares, due diligence fee shares and cash payment
issued to Fusion, together with the legal and accounting fees
associated with the transaction and the SEC registration, was
charged to stockholders equity during 2008 upon the
issuance of shares sold to Fusion pursuant to the Purchase
Agreement. During 2008 we sold 3,709,964 shares to Fusion
under the terms of the Purchase Agreement for an aggregate
purchase price of $500,000, and issued an additional
124,027 shares to Fusion pursuant to our deferred
commitment fee arrangement. During 2009 (through March 5), we
sold another 2,400,446 shares to Fusion for an aggregate
purchase price of $240,000, and issued an additional
59,532 shares pursuant to our deferred commitment fee
arrangement.
Stock
Options
In 2006 we adopted the GeoVax Labs, Inc. 2006 Equity Incentive
Plan (the 2006 Plan) for the granting of qualified
incentive stock options (ISOs), nonqualified
stock options, restricted stock awards or restricted stock
bonuses to employees, officers, directors, consultants and
advisors of the Company. The exercise price
F-14
GEOVAX
LABS, INC.
(A DEVELOPMENT-STAGE ENTERPRISE)
NOTES TO CONSOLIDATED FINANCIAL
STATEMENTS (Continued)
for any option granted may not be less than fair value (110% of
fair value for ISOs granted to certain employees). 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 our stock option activity under the 2006 Plan as of
December 31, 2008, and changes during the year then ended
is presented below:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Weighted-
|
|
|
|
|
|
|
|
|
|
Weighted-
|
|
|
Average
|
|
|
|
|
|
|
|
|
|
Average
|
|
|
Remaining
|
|
|
Aggregate
|
|
|
|
Number of
|
|
|
Exercise
|
|
|
Contractual
|
|
|
Intrinsic
|
|
|
|
Shares
|
|
|
Price
|
|
|
Term (yrs)
|
|
|
Value
|
|
|
Outstanding at January 1, ,2008
|
|
|
39,861,090
|
|
|
$
|
0.12
|
|
|
|
|
|
|
|
|
|
Granted
|
|
|
7,220,000
|
|
|
|
0.27
|
|
|
|
|
|
|
|
|
|
Exercised
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Forfeited or expired
|
|
|
(133,333
|
)
|
|
|
0.36
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Outstanding at December 31, 2008
|
|
|
46,947,757
|
|
|
$
|
0.12
|
|
|
|
6.3
|
|
|
$
|
1,613,776
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Exercisable at December 31, 2008
|
|
|
35,424,425
|
|
|
$
|
0.10
|
|
|
|
5.4
|
|
|
$
|
1,613,776
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Additional information concerning our stock options for the
years ended December 31, 2008, 2007 and 2006 is as follows:
|
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|
|
|
|
|
|
|
|
|
|
|
|
|
2008
|
|
|
2007
|
|
|
2006
|
|
|
Weighted average fair value of options granted during the period
|
|
$
|
0.12
|
|
|
$
|
0.30
|
|
|
$
|
|
|
Intrinsic value of options exercised during the period
|
|
|
|
|
|
|
22,181
|
|
|
|
|
|
Total fair value of options vested during the period
|
|
|
1,074,454
|
|
|
|
1,156,020
|
|
|
|
104,837
|
|
We use a Black-Scholes model for determining the grant date fair
value of our 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 we used in
our fair value calculations were as follows (during 2006, we did
not grant any stock options; therefore, fair value calculations
were not required):
|
|
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|
|
|
|
|
|
|
|
|
|
|
|
2008
|
|
|
2007
|
|
|
2006
|
|
|
Weighted average risk-free interest rates
|
|
|
2.9
|
%
|
|
|
4.5
|
%
|
|
|
|
|
Expected dividend yield
|
|
|
0.0
|
%
|
|
|
0.0
|
%
|
|
|
|
|
Expected life of option
|
|
|
7 yrs
|
|
|
|
6.8 yrs
|
|
|
|
|
|
Expected volatility
|
|
|
100.5
|
%
|
|
|
135
|
%
|
|
|
|
|
F-15
GEOVAX
LABS, INC.
(A DEVELOPMENT-STAGE ENTERPRISE)
NOTES TO CONSOLIDATED FINANCIAL
STATEMENTS (Continued)
Stock-based compensation expense related to the 2006 Plan was
$1,798,169, $1,296,196 and $-0- during the years ended
December 31, 2008, 2007 and 2006, respectively. The 2008
and 2007 expense includes $425,725 and $242,113, respectively,
associated with extensions of previously issued stock option
grants (accounted for as reissuances) which were due to expire
in 2007 to 2011. Stock option expense is allocated to research
and development expense or to general and administrative expense
based on the related employee classifications and corresponds to
the allocation of employee salaries. For the three years ended
December 31, 2008, stock option expense was allocated as
follows:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
2008
|
|
|
2007
|
|
|
2006
|
|
|
General and administrative expense
|
|
$
|
1,304,128
|
|
|
$
|
1,012,083
|
|
|
$
|
|
|
Research and development expense
|
|
|
494,041
|
|
|
|
284,113
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total stock option expense
|
|
$
|
1,798,169
|
|
|
$
|
1,296,196
|
|
|
$
|
|
|
As of December 31, 2008, there was $1,842,514 of
unrecognized compensation expense related to stock-based
compensation arrangements. The unrecognized compensation expense
is expected to be recognized over a weighted average remaining
period of 1.7 years.
Compensatory
Warrants
We may, from time to time, issue stock purchase warrants to
consultants or others in exchange for services. A summary of our
compensatory warrant activity as of December 31, 2008, and
changes during the year then ended is presented below:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Weighted-
|
|
|
|
|
|
|
|
|
|
Weighted-
|
|
|
Average
|
|
|
|
|
|
|
|
|
|
Average
|
|
|
Remaining
|
|
|
Aggregate
|
|
|
|
Number of
|
|
|
Exercise
|
|
|
Contractual
|
|
|
Intrinsic
|
|
|
|
Shares
|
|
|
Price
|
|
|
Term (yrs)
|
|
|
Value
|
|
|
Outstanding at January 1, ,2008
|
|
|
2,700,000
|
|
|
$
|
0.33
|
|
|
|
|
|
|
|
|
|
Granted
|
|
|
2,700,000
|
|
|
|
0.33
|
|
|
|
|
|
|
|
|
|
Exercised
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Forfeited or expired
|
|
|
(2,700,000
|
)
|
|
|
0.33
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Outstanding at December 31, 2008
|
|
|
2,700,000
|
|
|
$
|
0.33
|
|
|
|
3.0
|
|
|
$
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Exercisable at December 31, 2008
|
|
|
2,700,000
|
|
|
$
|
0.33
|
|
|
|
3.0
|
|
|
$
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Additional information concerning our compensatory warrants for
the years ended December 31, 2008, 2007 and 2006 is as
follows:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Year Ended December 31,
|
|
|
|
2008
|
|
|
2007
|
|
|
2006
|
|
|
Weighted average fair value of warrants granted during
|
|
$
|
0.05
|
|
|
$
|
0.25
|
|
|
$
|
|
|
the period
|
|
|
|
|
|
|
|
|
|
|
|
|
Intrinsic value of warrants exercised during the period
|
|
|
|
|
|
|
|
|
|
|
|
|
Total fair value of warrants vested during the period
|
|
|
146,880
|
|
|
|
266,760
|
|
|
|
|
|
F-16
GEOVAX
LABS, INC.
(A DEVELOPMENT-STAGE ENTERPRISE)
NOTES TO CONSOLIDATED FINANCIAL
STATEMENTS (Continued)
We use a Black-Scholes model for determining the grant date fair
value of our compensatory warrants. The significant assumptions
we used in our fair value calculations were as follows:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
2008
|
|
|
2007
|
|
|
2006
|
|
|
Weighted average risk-free interest rates
|
|
|
2.01
|
%
|
|
|
4.6
|
%
|
|
|
|
|
Expected dividend yield
|
|
|
0.0
|
%
|
|
|
0.0
|
%
|
|
|
|
|
Expected life of option
|
|
|
2.5 yrs
|
|
|
|
3 yrs
|
|
|
|
|
|
Expected volatility
|
|
|
99.0
|
%
|
|
|
113.6
|
%
|
|
|
|
|
Expense associated with compensatory warrants was $146,880,
$222,300 and $-0- during the years ended December 31, 2008,
2007 and 2006, respectively. All such expense was allocated to
general and administrative expense. As of December 31,
2008, there was no unrecognized compensation expense related to
our compensatory warrant arrangements.
Investment
Warrants
In addition to outstanding stock options and compensatory
warrants, as of December 31, 2008 we have a total of
65,181,345 outstanding stock purchase warrants issued to
investors with exercise prices ranging from $0.07 to $0.75 per
share. Such warrants have a weighted-average exercise price of
$0.25 per share and a weighted-average remaining contractual
life of 2.6 years.
We participate in a multi-employer defined contribution
retirement plan (the 401k Plan) administered by a
third party service provider, and the Company contributes to the
401k Plan on behalf of its employees based upon a matching
formula. During the years ended December 31, 2008, 2007 and
2006 our contributions to the 401k Plan were $11,691, $6,535 and
$6,744, respectively.
At December 31, 2008, we have a consolidated federal net
operating loss (NOL) carryforward of approximately
$70 million, available to offset against future taxable
income which expires in varying amounts in 2010 through 2028.
Additionally, we have approximately $355,000 in research and
development (R&D) tax credits that expire in
2022 through 2027 unless utilized earlier. No income taxes have
been paid to date.
As a result of the Merger discussed in Note 6, our NOL
carryforward increased substantially due to the addition of
approximately $59.7 million of historical NOL carryforwards
for Dauphin Technology, Inc. However, Section 382 of the
Internal Revenue Code contains provisions that may limit our
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.
F-17
GEOVAX
LABS, INC.
(A DEVELOPMENT-STAGE ENTERPRISE)
NOTES TO CONSOLIDATED FINANCIAL
STATEMENTS (Continued)
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 our
deferred tax assets and liabilities included the following at
December 31, 2008 and 2007:
|
|
|
|
|
|
|
|
|
|
|
2008
|
|
|
2007
|
|
|
Deferred tax assets:
|
|
|
|
|
|
|
|
|
Net operating loss carryforward
|
|
$
|
24,220,837
|
|
|
$
|
23,573,036
|
|
Research and development tax credit carryforward
|
|
|
354,581
|
|
|
|
354,581
|
|
Stock-based compensation expense
|
|
|
1,202,765
|
|
|
|
516,288
|
|
|
|
|
|
|
|
|
|
|
Total deferred tax assets
|
|
|
25,778,183
|
|
|
|
24,443,905
|
|
Deferred tax liabilities
|
|
|
|
|
|
|
|
|
Depreciation
|
|
|
8,738
|
|
|
|
6,994
|
|
|
|
|
|
|
|
|
|
|
Total deferred tax liabilities
|
|
|
8,738
|
|
|
|
6,994
|
|
|
|
|
|
|
|
|
|
|
Net deferred tax assets
|
|
|
25,769,445
|
|
|
|
24,436,911
|
|
Valuation allowance
|
|
|
(25,769,445
|
)
|
|
|
(24,436,911
|
)
|
|
|
|
|
|
|
|
|
|
|
|
$
|
|
|
|
$
|
|
|
|
|
|
|
|
|
|
|
|
We have established a full valuation allowance equal to the
amount of our net deferred tax assets due to uncertainties with
respect to our 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:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
2008
|
|
|
2007
|
|
|
2006
|
|
|
U.S. federal statutory rate applied to pretax loss
|
|
$
|
(1,267,584
|
)
|
|
$
|
(1,442,211
|
)
|
|
$
|
(198,616
|
)
|
Permanent differences
|
|
|
3,054
|
|
|
|
4,719
|
|
|
|
22,208
|
|
Research and development credits
|
|
|
|
|
|
|
100,296
|
|
|
|
51,863
|
|
Change in valuation allowance (excluding impact of the Merger
discussed in Note 6)
|
|
|
1,264,530
|
|
|
|
1,337,196
|
|
|
|
124,545
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Reported income tax expense
|
|
$
|
|
|
|
$
|
|
|
|
$
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
10.
|
Related
Party Transactions
|
We are obligated to reimburse Emory University (a significant
stockholder of the Company) for certain prior and ongoing costs
in connection with the filing, prosecution and maintenance of
patent applications subject to the Emory License (see
Note 3). The expense associated with these ongoing patent
cost reimbursements to Emory amounted to $102,141, $243,653 and
$98,842 for the years ended December 31, 2008, 2007 and
2006, respectively. As of December 31, 2008, we have
recorded $18,974 in accounts payable and accrued expenses
related to patent costs reimbursements to Emory.
In June 2008, we entered into two subcontracts with Emory for
the purpose of conducting research and development activities
associated with our grant from the NIH (see Note 4). During
2008, we recorded $723,887 of expense associated with these
subcontracts, $151,188 of which was owed to Emory as of
December 31, 2008. All amounts paid to Emory under these
subcontracts are reimbursable to us pursuant to the NIH grant.
F-18
GEOVAX
LABS, INC.
(A DEVELOPMENT-STAGE ENTERPRISE)
NOTES TO CONSOLIDATED FINANCIAL
STATEMENTS (Continued)
In March 2008, we entered into a consulting agreement with
Donald Hildebrand, the Chairman of our Board of Directors and
our former President & Chief Executive Officer,
pursuant to which Mr. Hildebrand provides business and
technical advisory services to the Company. The term of the
consulting agreement began on April 1, 2008 and will end on
December 31, 2009. During 2008, we recorded $64,000 of
expense associated with the consulting agreement. No amounts
were owed to Mr. Hildebrand as of December 31, 2008.
|
|
11.
|
Selected
Quarterly Financial Data (unaudited)
|
A summary of selected quarterly financial data for 2008 and 2007
is as follows:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
2008 Quarter Ended
|
|
|
|
March 31
|
|
|
June 30
|
|
|
September 30
|
|
|
December 31
|
|
|
Revenue from grants
|
|
$
|
599,991
|
|
|
$
|
376,078
|
|
|
$
|
1,322,502
|
|
|
$
|
611,599
|
|
Net loss
|
|
|
(682,510
|
)
|
|
|
(1,284,352
|
)
|
|
|
(722,108
|
)
|
|
|
(1,039,217
|
)
|
Net loss per share
|
|
|
(0.00
|
)
|
|
|
(0.00
|
)
|
|
|
(0.00
|
)
|
|
|
(0.00
|
)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
2007 Quarter Ended
|
|
|
|
March 31
|
|
|
June 30
|
|
|
September 30
|
|
|
December 31
|
|
|
Revenue from grants
|
|
$
|
|
|
|
$
|
|
|
|
$
|
|
|
|
$
|
237,004
|
|
Net loss
|
|
|
(587,281
|
)
|
|
|
(1,333,126
|
)
|
|
|
(1,165,519
|
)
|
|
|
(1,155,870
|
)
|
Net loss per share
|
|
|
(0.00
|
)
|
|
|
(0.00
|
)
|
|
|
(0.00
|
)
|
|
|
(0.00
|
)
|
F-19
GEOVAX
LABS, INC.
SCHEDULE II
VALUATION AND QUALIFYING ACCOUNTS
For
the Years Ended December 31, 2008, 2007 and 2006
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Additions
|
|
|
|
|
|
|
|
|
|
Balance at
|
|
|
Charged to
|
|
|
Charged to
|
|
|
|
|
|
Balance at
|
|
|
|
Beginning
|
|
|
Costs and
|
|
|
Other
|
|
|
|
|
|
End
|
|
Description
|
|
of Period
|
|
|
Expenses
|
|
|
Accounts
|
|
|
Deductions
|
|
|
of Period
|
|
|
Reserve Deducted in the Balance Sheet
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
From the Asset to Which it Applies:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Allowance for Deferred Tax Assets
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Year ended December 31, 2008
|
|
$
|
24,436,911
|
|
|
$
|
1,332,534
|
|
|
$
|
|
|
|
$
|
|
|
|
$
|
25,769,445
|
|
Year ended December 31, 2007
|
|
$
|
22,792,303
|
|
|
$
|
1,644,608
|
|
|
$
|
|
|
|
$
|
|
|
|
$
|
24,436,911
|
|
Year ended December 31, 2006
|
|
|
2,257,226
|
|
|
|
20,535,077
|
|
|
$
|
|
|
|
$
|
|
|
|
|
22,792,303
|
|
F-20
GEOVAX LABS, INC.
(A DEVELOPMENT-STAGE ENTERPRISE)
CONDENSED CONSOLIDATED BALANCE SHEETS
|
|
|
|
|
|
|
|
|
|
|
March 31, |
|
|
December 31, |
|
|
|
2009 |
|
|
2008 |
|
|
|
(Unaudited) |
|
|
|
|
|
ASSETS |
|
|
|
|
|
|
|
|
Current assets: |
|
|
|
|
|
|
|
|
Cash and cash equivalents |
|
$ |
1,970,971 |
|
|
$ |
2,191,180 |
|
Grant funds receivable |
|
|
285,112 |
|
|
|
311,368 |
|
Prepaid expenses and other |
|
|
273,683 |
|
|
|
299,286 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total current assets |
|
|
2,529,766 |
|
|
|
2,801,834 |
|
|
|
|
|
|
|
|
|
|
Property and equipment, net of accumulated depreciation of $123,824 and
$112,795 at March 31, 2009 and December 31, 2008, respectively |
|
|
127,818 |
|
|
|
138,847 |
|
|
|
|
|
|
|
|
|
|
Other assets: |
|
|
|
|
|
|
|
|
Licenses, net of accumulated amortization of $140,497 and $134,276
at March 31, 2009 and December 31, 2008, respectively |
|
|
108,359 |
|
|
|
114,580 |
|
Deposits and other |
|
|
3,480 |
|
|
|
980 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total other assets |
|
|
111,839 |
|
|
|
115,560 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total assets |
|
$ |
2,769,423 |
|
|
$ |
3,056,241 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
LIABILITIES AND STOCKHOLDERS EQUITY |
|
|
|
|
|
|
|
|
Current liabilities: |
|
|
|
|
|
|
|
|
Accounts payable and accrued expenses |
|
$ |
169,293 |
|
|
$ |
176,260 |
|
Amounts payable to Emory University (a related party) |
|
|
123,000 |
|
|
|
170,162 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total current liabilities |
|
|
292,293 |
|
|
|
346,422 |
|
|
|
|
|
|
|
|
|
|
Commitments |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Stockholders equity: |
|
|
|
|
|
|
|
|
Common stock, $.001 par value, 900,000,000 shares authorized
749,908,854 and 747,448,876 shares outstanding at
March 31, 2009 and December 31, 2008, respectively |
|
|
749,909 |
|
|
|
747,449 |
|
Additional paid-in capital |
|
|
16,842,326 |
|
|
|
16,215,966 |
|
Deficit accumulated during the development stage |
|
|
(15,115,105 |
) |
|
|
(14,253,596 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total stockholders equity |
|
|
2,477,130 |
|
|
|
2,709,819 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total liabilities and stockholders equity |
|
$ |
2,769,423 |
|
|
$ |
3,056,241 |
|
|
|
|
|
|
|
|
See accompanying notes to financial statements.
F-21
GEOVAX LABS, INC.
(A DEVELOPMENT-STAGE ENTERPRISE)
CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS
(Unaudited)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
From Inception |
|
|
|
Three Months Ended |
|
|
(June 27, 2001) to |
|
|
|
March 31, |
|
|
March 31, |
|
|
|
2009 |
|
|
2008 |
|
|
2009 |
|
Grant revenue |
|
$ |
710,155 |
|
|
$ |
599,991 |
|
|
$ |
7,268,510 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Operating expenses: |
|
|
|
|
|
|
|
|
|
|
|
|
Research and development |
|
|
857,236 |
|
|
|
603,478 |
|
|
|
13,348,899 |
|
General and administrative |
|
|
723,815 |
|
|
|
705,642 |
|
|
|
9,321,940 |
|
|
|
|
|
|
|
|
|
|
|
Total operating expenses |
|
|
1,581,051 |
|
|
|
1,309,120 |
|
|
|
22,670,839 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Loss from operations |
|
|
(870,896 |
) |
|
|
(709,129 |
) |
|
|
(15,402,329 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
Other income (expense): |
|
|
|
|
|
|
|
|
|
|
|
|
Interest income |
|
|
9,387 |
|
|
|
26,619 |
|
|
|
292,893 |
|
Interest expense |
|
|
|
|
|
|
|
|
|
|
(5,669 |
) |
|
|
|
|
|
|
|
|
|
|
Total other income (expense) |
|
|
9,387 |
|
|
|
26,619 |
|
|
|
287,224 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net loss |
|
$ |
(861,509 |
) |
|
$ |
(682,510 |
) |
|
$ |
(15,115,105 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Basic and diluted: |
|
|
|
|
|
|
|
|
|
|
|
|
Loss per common share |
|
$ |
(0.00 |
) |
|
$ |
(0.00 |
) |
|
$ |
(0.03 |
) |
|
|
|
|
|
|
|
|
|
|
Weighted average shares outstanding |
|
|
748,875,047 |
|
|
|
731,794,959 |
|
|
|
436,755,054 |
|
|
|
|
|
|
|
|
|
|
|
See accompanying notes to financial statements.
F-22
GEOVAX LABS, INC.
(A DEVELOPMENT-STAGE ENTERPRISE)
CONDENSED CONSOLIDATED STATEMENTS OF STOCKHOLDERS EQUITY (DEFICIENCY)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Deficit |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Accumulated |
|
|
Total |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Stock |
|
|
during the |
|
|
Stockholders |
|
|
|
Common Stock |
|
|
Additional |
|
|
Subscription |
|
|
Development |
|
|
Equity |
|
|
|
Shares |
|
|
Amount |
|
|
Paid In 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 preferred stock to common stock |
|
|
177,542,538 |
|
|
|
177,543 |
|
|
|
897,573 |
|
|
|
|
|
|
|
|
|
|
|
1,075,116 |
|
Common stock issued in connection with merger |
|
|
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 |
|
Sale of common stock for cash |
|
|
20,336,433 |
|
|
|
20,336 |
|
|
|
3,142,614 |
|
|
|
|
|
|
|
|
|
|
|
3,162,950 |
|
Issuance of common stock upon stock option exercise |
|
|
123,550 |
|
|
|
124 |
|
|
|
4,876 |
|
|
|
|
|
|
|
|
|
|
|
5,000 |
|
Stock-based compensation expense |
|
|
|
|
|
|
|
|
|
|
1,518,496 |
|
|
|
|
|
|
|
|
|
|
|
1,518,496 |
|
Net loss for the year ended December 31, 2007 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(4,241,796 |
) |
|
|
(4,241,796 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Balance at December 31, 2007 |
|
|
731,627,926 |
|
|
|
731,628 |
|
|
|
12,441,647 |
|
|
|
|
|
|
|
(10,525,409 |
) |
|
|
2,647,866 |
|
Continued on following page
F-23
GEOVAX LABS, INC.
(A DEVELOPMENT-STAGE ENTERPRISE)
CONDENSED CONSOLIDATED STATEMENTS OF STOCKHOLDERS EQUITY (DEFICIENCY)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Deficit |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Accumulated |
|
|
Total |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Stock |
|
|
during the |
|
|
Stockholders |
|
|
|
Common Stock |
|
|
Additional |
|
|
Subscription |
|
|
Development |
|
|
Equity |
|
|
|
Shares |
|
|
Amount |
|
|
Paid In Capital |
|
|
Receivable |
|
|
Stage |
|
|
(Deficiency) |
|
Balance at December 31, 2007 |
|
|
731,627,926 |
|
|
|
731,628 |
|
|
|
12,441,647 |
|
|
|
|
|
|
|
(10,525,409 |
) |
|
|
2,647,866 |
|
Sale of common stock for cash in private
placement transactions |
|
|
8,806,449 |
|
|
|
8,806 |
|
|
|
1,356,194 |
|
|
|
|
|
|
|
|
|
|
|
1,365,000 |
|
Transactions related to common stock purchase
agreement with Fusion Capital |
|
|
6,514,501 |
|
|
|
6,515 |
|
|
|
399,576 |
|
|
|
|
|
|
|
|
|
|
|
406,091 |
|
Stock-based compensation: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Stock options |
|
|
|
|
|
|
|
|
|
|
1,798,169 |
|
|
|
|
|
|
|
|
|
|
|
1,798,169 |
|
Consultant warrants |
|
|
|
|
|
|
|
|
|
|
146,880 |
|
|
|
|
|
|
|
|
|
|
|
146,880 |
|
Issuance of common stock for consulting services |
|
|
500,000 |
|
|
|
500 |
|
|
|
73,500 |
|
|
|
|
|
|
|
|
|
|
|
74,000 |
|
Net loss for the year ended December 31, 2008 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(3,728,187 |
) |
|
|
(3,728,187 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Balance at December 31, 2008 |
|
|
747,448,876 |
|
|
|
747,449 |
|
|
|
16,215,966 |
|
|
|
|
|
|
|
(14,253,596 |
) |
|
|
2,709,819 |
|
Transactions related to common stock purchase
agreement with Fusion Capital (unaudited) |
|
|
2,459,978 |
|
|
|
2,460 |
|
|
|
237,540 |
|
|
|
|
|
|
|
|
|
|
|
240,000 |
|
Stock-based compensation expense (unaudited) |
|
|
|
|
|
|
|
|
|
|
388,820 |
|
|
|
|
|
|
|
|
|
|
|
388,820 |
|
Net loss for the three months ended |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
March 31, 2009 (unaudited) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(861,509 |
) |
|
|
(861,509 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Balance at March 31, 2009 (unaudited) |
|
|
749,908,854 |
|
|
$ |
749,909 |
|
|
$ |
16,842,326 |
|
|
$ |
|
|
|
$ |
(15,115,105 |
) |
|
$ |
2,477,130 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
See accompanying notes to financial statements.
F-24
GEOVAX LABS, INC.
(A DEVELOPMENT STAGE ENTERPRISE)
CONDENSED CONSOLIDATED STATEMENTS OF CASH FLOWS
(unaudited)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Three Months Ended |
|
|
From Inception |
|
|
|
March 31, |
|
|
(June 27, 2001) to |
|
|
|
2009 |
|
|
2008 |
|
|
March 31, 2009 |
|
|
Cash flows from operating activities: |
|
|
|
|
|
|
|
|
|
|
|
|
Net loss |
|
$ |
(861,509 |
) |
|
$ |
(682,510 |
) |
|
$ |
(15,115,105 |
) |
Adjustments to reconcile net loss to net cash
used in operating activities: |
|
|
|
|
|
|
|
|
|
|
|
|
Depreciation and amortization |
|
|
17,250 |
|
|
|
12,688 |
|
|
|
264,321 |
|
Accretion of preferred stock redemption value |
|
|
|
|
|
|
|
|
|
|
346,673 |
|
Stock-based compensation expense |
|
|
388,820 |
|
|
|
398,596 |
|
|
|
3,926,365 |
|
Changes in assets and liabilities: |
|
|
|
|
|
|
|
|
|
|
|
|
Grant funds receivable |
|
|
26,256 |
|
|
|
(26,676 |
) |
|
|
(285,112 |
) |
Prepaid expenses and other current assets |
|
|
25,603 |
|
|
|
(3,199 |
) |
|
|
(273,683 |
) |
Other assets |
|
|
(2,500 |
) |
|
|
|
|
|
|
(3,480 |
) |
Accounts payable and accrued expenses |
|
|
(54,129 |
) |
|
|
(463,870 |
) |
|
|
292,293 |
|
|
|
|
|
|
|
|
|
|
|
Total adjustments |
|
|
401,300 |
|
|
|
(82,461 |
) |
|
|
4,267,377 |
|
|
|
|
|
|
|
|
|
|
|
Net cash used in operating activities |
|
|
(460,209 |
) |
|
|
(764,971 |
) |
|
|
(10,847,728 |
) |
|
Cash flows from investing activities: |
|
|
|
|
|
|
|
|
|
|
|
|
Purchase of property and equipment |
|
|
|
|
|
|
(2,238 |
) |
|
|
(251,642 |
) |
|
|
|
|
|
|
|
|
|
|
Net cash used in investing activities |
|
|
|
|
|
|
(2,238 |
) |
|
|
(251,642 |
) |
|
Cash flows from financing activities: |
|
|
|
|
|
|
|
|
|
|
|
|
Net proceeds from sale of common stock |
|
|
240,000 |
|
|
|
897,450 |
|
|
|
12,336,898 |
|
Net proceeds from exercise of stock options |
|
|
|
|
|
|
|
|
|
|
5,000 |
|
Net proceeds from sale of preferred stock |
|
|
|
|
|
|
|
|
|
|
728,443 |
|
|
|
|
|
|
|
|
|
|
|
Net cash provided by financing activities |
|
|
240,000 |
|
|
|
897,450 |
|
|
|
13,070,341 |
|
|
Net increase (decrease) in cash and cash equivalents |
|
|
(220,209 |
) |
|
|
130,241 |
|
|
|
1,970,971 |
|
Cash and cash equivalents at beginning of period |
|
|
2,191,180 |
|
|
|
1,990,356 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Cash and cash equivalents at end of period |
|
$ |
1,970,971 |
|
|
$ |
2,120,597 |
|
|
$ |
1,970,971 |
|
|
|
|
|
|
|
|
|
|
|
|
Supplemental disclosure of cash flow information: |
|
|
|
|
|
|
|
|
|
|
|
|
Interest paid |
|
$ |
|
|
|
$ |
|
|
|
$ |
5,669 |
|
See accompanying notes to financial statements.
F-25
GEOVAX LABS, INC.
(A DEVELOPMENT-STAGE ENTERPRISE)
NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
(Unaudited)
March 31, 2009
1. Description of Company and Basis of Presentation
GeoVax Labs, Inc. (GeoVax or the Company), is a biotechnology company focused on developing
human vaccines for diseases caused by Human Immunodeficiency Virus (HIV) and other infectious
agents. The Company has exclusively licensed from Emory University (Emory) vaccine technology
which was developed in collaboration with the National Institutes of Health (NIH) and the Centers
for Disease Control and Prevention (CDC). The Company is incorporated under the laws of the
State of Delaware and its principal offices are located in Atlanta, Georgia.
The Company is devoting all of its present efforts to research and development and is a development
stage enterprise as defined by Statement of Financial Accounting Standards (SFAS) No. 7,
Accounting and Reporting by Development Stage Enterprises. The accompanying financial statements
at March 31, 2009 and for the three month periods ended March 31, 2009 and 2008 are unaudited, but
include all adjustments, consisting of normal recurring entries, which we believe to be necessary
for a fair presentation of the dates and periods presented. Interim results are not necessarily
indicative of results for a full year. The financial statements should be read in conjunction with
our audited financial statements included in our Annual Report on Form 10-K for the year ended
December 31, 2008. Our 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 in
future periods.
The Company disclosed in Note 2 to its financial statements included in the Form 10-K for the year
ended December 31, 2008 those accounting policies that it considers significant in determining its
results of operations and financial position. There have been no material changes to, or
application of, the accounting policies previously identified and described in the Form 10-K.
2. New Accounting Pronouncements
Effective January 1, 2008, we adopted Financial Accounting Standards Board (FASB) Statement of
Financial Accounting Standards No. 157, Fair Value Measurements (SFAS 157). SFAS 157 provides
enhanced guidance for using fair value to measure assets and liabilities. SFAS 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 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. In February 2008, the FASB issued Staff Position No.
157-2, (FSP 157-2) which delayed the January 1, 2008 effective date of SFAS 157 for all
nonfinancial assets and nonfinancial liabilities, except those already being recognized or
disclosed at fair value in the financial statements on a recurring basis (at least annually), until
January 1, 2009. Implementation of these standards had no effect on our results of operations,
financial position, or cash flows.
Effective January 1, 2009, we adopted FASB Statement of Financial Accounting Standards No. 161,
Disclosures about Derivative Instruments and Hedging Activities (SFAS 161). SFAS 161 amends
and expands the disclosure requirements of SFAS 133, Accounting for Derivative Instruments and
Hedging. The adoption of SFAS 161 had no effect on our results of operations, financial position,
or cash flows.
Effective January 1, 2009, we adopted FASB Staff Position No. 142-3, Determination of the Useful
Life of Intangible Assets (FSP 142-3). FSP 142-3 amends the factors that should be considered in
developing renewal or extension assumptions used to determine the useful life of a recognized
intangible asset under FASB Statement of Financial Accounting Standards No. 142, Goodwill and
Other Intangible Assets. The adoption of FSP 142-3 had no effect on our results of operations,
financial position, or cash flows.
Effective January 1, 2009, we adopted FASB Staff Position No. EITF 03-6-1, Determining Whether
Instruments Granted in Share-Based Payment Transactions Are Participating Securities (EITF
03-6-1). EITF 03-6-1 addresses whether instruments granted in share-based payment transactions are
participating securities prior to vesting, and therefore, need to be included in the earnings
allocation in calculating earnings per share under the two-class method described in FASB Statement
of Financial Accounting Standards No. 128, Earnings per Share. EITF 03-6-1 requires companies to
treat
F-26
unvested share-based payment awards that have non-forfeitable rights to dividend or dividend
equivalents as a separate class of securities in calculating earnings per share. The adoption of
EITF 03-6-1 had no effect on our results of operations, financial position, or cash flows.
In May 2008, the FASB issued Statement of Financial Accounting Standards No. 162, The Hierarchy of
Generally Accepted Accounting Principles (SFAS 162). SFAS 162 identifies the sources of
accounting principles and the framework for selecting the principles to be used in the preparation
of financial statements of nongovernmental entities that are presented in conformity with generally
accepted accounting principles in the United States. SFAS 162 will become effective 60 days
following Securities and Exchange Commission (SEC) approval of the Public Company Accounting
Oversight Board (PCAOB) amendments to AU Section 411, The Meaning of Present Fairly in Conformity
With Generally Accepted Accounting Principles. We do not anticipate the adoption of SFAS 162 will
have a material, if any, effect on our results of operations, financial position, or cash flows.
In April 2009, the FASB issued Staff Position FAS 107-1 and APB 28-1, Interim Disclosures about
Fair Value of Financial Instruments (FSP FAS 107-1 and APB 28-1). FSP FAS 107-1 and APB 28-1
amends FASB Statement No. 107, Disclosures about Fair Value of Financial Instruments, to require
disclosures about fair value of financial instruments in interim as well as in annual financial
statements. FSP FAS 107-1 and APB 28-1 also amends APB Opinion No. 28, Interim Financial
Reporting, to require those disclosures in all interim financial statements. FSP FAS 107-1 and
APB 28-1 is effective for periods ending after June 15, 2009. We will adopt FSP FAS 107-1 and APB
28-1 in the second quarter of 2009 and currently do not expect that such adoption will have a
material, if any, effect on our results of operations, financial position, or cash flows.
We do not believe that any other recently issued, but not yet effective, accounting or reporting
standards if currently adopted would have a material effect on our financial statements.
3. Basic and Diluted Loss Per Common Share
Basic net loss per share is computed using the weighted-average number of common shares outstanding
during the period. Diluted net loss per share is computed using the weighted-average number of
common shares and potentially dilutive common shares outstanding during the period. Potentially
dilutive common shares primarily consist of employee stock options and warrants issued to
investors. Common share equivalents which potentially could dilute basic earnings per share in the
future, and which were excluded from the computation of diluted loss per share, as the effect would
be anti-dilutive, totaled approximately 114.8 million and 93.6 million shares at March 31, 2009 and
2008, respectively.
4. Stockholders Equity
Common Stock Purchase Agreement
In May 2008, we signed a common stock purchase agreement (the Purchase Agreement) with Fusion
Capital Fund II, LLC (Fusion). The Purchase Agreement allows us to require Fusion to purchase up
to $10 million of our common stock in amounts ranging from $80,000 to $1.0 million per purchase
transaction, depending on certain conditions, from time to time over a 25-month period beginning
July 1, 2008, the date on which the SEC declared effective the registration statement related to
the transaction.
The purchase price of the shares relating to the Purchase Agreement is based on the prevailing
market prices of our shares at the times of the sales without any fixed discount, and we control
the timing and amounts of any sales of shares to Fusion. Fusion does not have the right or the
obligation to purchase any shares of our common stock on any business day that the purchase price
of our common stock is below $0.05 per share. As primary consideration for entering into the
Purchase Agreement, and upon the execution of the Purchase Agreement we issued to Fusion 2,480,510
shares of our common stock as a commitment fee, and we agreed to issue to Fusion up to an
additional 2,480,510 commitment fee shares, on a pro rata basis, as we receive the $10 million of
future funding. The Purchase Agreement may be terminated by us at any time at our discretion
without any additional cost to us. There are no negative covenants, restrictions on future
financings, penalties or liquidated damages in the agreement.
During the three months ended March 31, 2009, we sold 2,400,446 shares to Fusion under the terms of
the Purchase Agreement for an aggregate purchase price of $240,000, and issued an additional 59,532
shares to Fusion pursuant to the pro rata deferred commitment fee arrangement mentioned above.
During April 2009, we sold another 1,850,007 shares to Fusion for an aggregate purchase price of
$180,000, and issued an additional 44,649 shares pursuant to the deferred commitment fee
arrangement.
F-27
Stock Options
In 2006 we adopted the GeoVax Labs, Inc. 2006 Equity Incentive Plan (the 2006 Plan) for the
granting of qualified incentive stock options (ISOs), nonqualified stock options, restricted
stock awards or restricted stock bonuses to employees, officers, directors, consultants and
advisors of the Company. The exercise price for any option granted may not be less than fair value
(110% of fair value for ISOs granted to certain employees). 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.
There was no activity in the 2006 Plan for the three months ended March 31, 2009. As of March 31,
2009, there were nonqualified stock options covering a total of 46,947,757 shares of our common
stock outstanding with a weighted average exercise price of $0.13 and a weighted average remaining
contractual term of 6.1 years; including options as to 35,474,425 shares currently exercisable,
with a weighted average exercise price of $0.10 and a weighted average remaining contractual term
of 5.1 years.
Stock-based compensation expense related to the 2006 Plan was $388,820 and $380,346 for the three
month periods ended March 31, 2009 and 2008, respectively. The table below shows the allocation of
stock-based compensation expense related to our stock option plan between general and
administrative expense and research and development expense. As of March 31, 2009, there was
$1,461,503 of unrecognized compensation expense related to stock-based compensation arrangements
subject to the 2006 Plan, which is expected to be recognized over a weighted average period of 1.6
years.
|
|
|
|
|
|
|
|
|
|
|
Three Months Ended March 31, |
Expense Allocated to: |
|
2009 |
|
2008 |
General and Administrative Expense |
|
$ |
303,381 |
|
|
$ |
308,409 |
|
Research and Development Expense |
|
|
85,439 |
|
|
|
37,917 |
|
|
|
|
|
|
|
|
|
|
Total Stock-Based Compensation Expense Related to 2006 Plan |
|
$ |
388,820 |
|
|
$ |
346,326 |
|
|
|
|
|
|
|
|
|
|
Compensatory Warrants
We may, from time to time, issue stock purchase warrants to consultants or others in exchange for
services. As of March 31, 2009, there were a total of 2,700,000 shares of our common stock covered
by outstanding stock warrants all of which are currently exercisable at a weighted average exercise
price of $0.33 per share and a weighted-average remaining contractual life of 2.8 years. Expense
associated with compensatory warrants was $-0- and $34,020, for three month periods ended March 31,
2009 and 2008, respectively, all of which was allocated to general and administrative expense. As
of March 31, 2009, there was no unrecognized compensation expense related to compensatory warrant
arrangements.
Investment Warrants
In addition to outstanding stock options and compensatory warrants, as of March 31, 2009 we had
stock purchase warrants covering a total of 65,181,345 shares of our common stock which were issued
to investors in our previous private placements. Such warrants have a weighted-average exercise
price of $0.25 per share and a weighted-average remaining contractual life of 2.4 years.
5. Income Taxes
Because of our historically significant net operating losses, we have not paid income taxes since
inception. We maintain deferred tax assets that reflect the net tax effects of temporary
differences between the carrying amounts of assets and liabilities for financial reporting purposes
and the amounts used for income tax purposes. These deferred tax assets are comprised primarily of
net operating loss carryforwards and also include amounts relating to nonqualified stock options
and research and development credits. The net deferred tax asset has been fully offset by a
valuation allowance because of the uncertainty of our future profitability and our ability to
utilize the deferred tax assets. Utilization of operating losses and credits may be subject to
substantial annual limitations due to ownership change provisions of Section 382 of the Internal
Revenue Code. The annual limitation may result in the expiration of net operating losses and
credits before utilization.
6. NIH Grant Funding
In September 2007, the National Institutes of Health (NIH) awarded us an Integrated
Preclinical/Clinical AIDS Vaccine Development (IPCAVD) grant to support our HIV/AIDS vaccine
program. The project period for the grant, which is renewable annually, covers a five year period
which commenced October 2007, with an expected annual award of between
F-28
$3 and $4 million per year (approximately $17 million in the aggregate). We are utilizing this
funding to further our HIV/AIDS vaccine development, optimization, production and human clinical
trial testing. We record revenue associated with the grant as the related costs and expenses are
incurred. During the three months ended March 31, 2009 and 2008, we recorded $710,155 and
$599,991, respectively, of revenue associated with the grant.
7. Related Party Transactions
In June 2008, we entered into two subcontracts with Emory for the purpose of conducting research
and development activities associated with our grant from the NIH (see Note 6). During the three
month period ending March 31, 2009, we recorded $218,632 of expense associated with these
subcontracts. All amounts paid to Emory under these subcontracts are reimbursable to us pursuant
to the NIH grant.
In March 2008, we entered into a consulting agreement with Donald Hildebrand, the Chairman of our
Board of Directors and our former President & Chief Executive Officer, pursuant to which Mr.
Hildebrand provides business and technical advisory services to the Company. The term of the
consulting agreement began on April 1, 2008 and will end on December 31, 2009. During the three
month period ending March 31, 2009, we recorded $14,400 of expense associated with the consulting
agreement.
F-29