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GeoVax Labs, Inc. Reports Fourth Quarter and Year-End 2007 Financial Results

ATLANTA, March 14 /PRNewswire-FirstCall/ -- GeoVax Labs, Inc. (OTC Bulletin Board: GOVX), an Atlanta-based biotechnology company focused on development of an HIV/AIDS vaccine, today announced its financial results for the fourth quarter and year ended December 31, 2007.

GeoVax recorded a net loss of $1,155,870 for the fourth quarter ended December 31, 2007, as compared to $157,276 for the comparable period in 2006. For the full year of 2007, the Company recorded a net loss of $4,241,796 as compared to $584,166 in 2006. GeoVax's operating results fluctuate due to the timing of activities and related costs associated with its vaccine research and development activities. The overall increase in the Company's net loss from 2006 to 2007 is primarily attributable to:

-- Substantial costs for manufacture and testing of AIDS vaccines for

Phase 2 human trials planned for summer 2008.

-- Increased research and development expenditures as the Company

continued to support its three ongoing Phase 1 human AIDS vaccine

clinical trials and prepares for initiation of Phase 2 trials in 2008.

-- Lower grant revenues during 2007. During the first nine months of

2007, GeoVax had no grant revenues. During the fourth quarter of 2007,

the Company recorded $234,004 in grant revenues associated with an

estimated $15 million, 5 year grant from the NIH (see discussion


-- Overall higher general and administrative costs due to the additional

costs associated with being a public company subsequent to the merger

between Dauphin Technology, Inc. and GeoVax, Inc. in September 2006.

These higher costs included expansion of the Company's management team,

initiation of an investor relations program, increased legal and

accounting costs, and costs associated with achieving compliance with

the Sarbanes-Oxley Act of 2002.

-- Stocs, risks detailed in the Companies Securities and Exchange Commission filings and reports.


Statements of Operations Data


(amounts in thousands, except per share data)

Three Months Ended Twelve Months Ended

December 31, December 31,

2007 2006 2007 2006

Grant Revenue $237 $374 $237 $853

Operating expenses:

Research and

development 484 156 1,757 666

General and

administrative 919 405 2,784 843

1,403 561 4,541 1,509

Loss from operations (1,166) (187) (4,304) (656)

Interest income 10 30 62 72

Net loss $(1,156) $(157) $(4,242) $(584)

Net loss per common

share $(0.00) $0.00 $(0.00) $(0.00)

Weighted averages

shares outstanding 717,925 709,354 714,102 414,919

Balance Sheet Data


(amounts in thousands)

December 31,

2007 2006

Cash and cash equivalents $1,990 $2,088

Working capital 1,392 1,933

Total assets 2,349 2,396

Deficit accumulated during the

development stage (10,525) (6,284)

Total stockholders' equity 1,750 2,203

k-based compensation expense of $1,518,496 during 2007. In

accordance with accounting rules, no stock-based compensation expense

was recorded during 2006. This was an accounting adjustment and did not

result in actual cash expenditures.

Summarized financial information is shown below. GeoVax's full set of audited financial statements are included in its Form 10-K filing with the Securities and Exchange Commission.

2007 and Early 2008 Highlights:

-- In July, GeoVax announced an early start of two new HIV/AIDS vaccine

clinical (human) trials. These FDA compliant trials were previously

scheduled to start later in 2007 and are the 3rd and 4th in a four

clinical trial series intended to evaluate both human safety and immune

responses to GeoVax's HIV/AIDS vaccines. Starting April 2006, the 1st

of these four trials evaluated a low dose (1/10th of the vaccine dose)

vaccination program. Results from this blinded trial demonstrated

excellent vaccine safety and positive anti-HIV-1 immune responses. All

trial participants were normal, healthy individuals. The 2nd of four

trials, initiated September 2006, is designed to evaluate results from

full dose administration of GeoVax HIV/AIDS vaccines. Recent data

indicates excellent safety in this full dose trial with immune response

data from the majority of vaccine recipients.

-- In June and July, GeoVax announced it engaged Althea Technologies,

Inc., and BioReliance Corporation, as contract manufacturers for its

HIV-1 DNA and HIV-1 MVA (AIDS) vaccines. These vaccines will be

utilized in GeoVax's advanced Phase 2 clinical trials planned for 2008.

GeoVax HIV/AIDS vaccines are designed to prevent development of

Acquired Immunodeficiency Disease (AIDS) caused by the virus known as

HIV-1 by vaccinating individuals prior to AIDS virus infection. The

vaccine regimen employs a two-vaccine "prime-boost strategy." Trial

participants will be administered GeoVax HIV-1 DNA vaccine which

"primes" the immune system followed by GeoVax's HIV-1 MVA (Modified

Vaccinia Virus) boost. Both vaccines deliver over 50% of the AIDS virus

components but can not cause AIDS. Safety and immunological results

from earlier as well as ongoing human trials are very encouraging thus

supporting planned acceleration of large scale Phase 2 clinical


-- In September, GeoVax announced receipt of an estimated $15 million

Integrated Preclinical/Clinical AIDS Vaccine Development [IPCAVD] Grant

to support its HIV/AIDS vaccine program. This large Grant was awarded

by the National Institutes of Health-National Institute of Allergy &

Infectious Disease [NIH-NIAID], an agency of the U.S. Government. The

grant funding period is over a five year period commencing October

2007. 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. GeoVax will utilize this funding to

further its HIV/AIDS vaccine development, optimization, production and

human clinical trial testing.

GeoVax announced in January 2008 that it had been recognized by Georgia

Bio, the state trade organization, as a 2007 "Deal of the Year" award

winner for receipt of the $15 million IPCAVD grant.

-- In September, GeoVax announced the presentation of successful human

trial results for its HIV/AIDS vaccines at the AIDS Vaccine 2007

Conference held August 20-23, 2007 in Seattle, Washington. GeoVax

HIV/AIDS human trial results were presented by Dr. Paul Goepfert, MD in

a talk "HIV-1 DNA Prime followed by Recombinant MVA Boost is Well

Tolerated and Immunogenic When Administered to Healthy Seronegative

Adults." Dr. Goepfert, from the University of Alabama-Birmingham, is

Protocol Chair of HVTN 065, a series of human clinical trials currently

evaluating GeoVax's HIV/AIDS vaccine. GeoVax HIV/AIDS vaccine trial

data was presented to over 900 AIDS researchers at the week long

conference. Conference Chair, Dr. Lawrence Corey stated, "It has become

clear that a preventative vaccine is essential to controlling the

global AIDS epidemic." The AIDS Vaccine 2007 Conference was organized

under the guidance of the Global HIV Vaccine Enterprise, an alliance of

independent global organizations dedicated to accelerating preventative

AIDS vaccine development. The conference reported the AIDS epidemic

continuing as a global threat with the disease increasing in every

region of the world, especially East and Central Asia and Eastern

Europe where AIDS incidence was 21% higher in 2006 than in 2004.

Key GeoVax HIV/AIDS Vaccine Human Trial conclusions presented at the

AIDS Vaccine 2007 Conference included:

-- GeoVax DNA and MVA vaccines are safe and immunogenic (stimulate

anti-HIV/AIDS immune responses) at both low (1/10th) dose and full


-- GeoVax vaccines were well tolerated with no or mild local and


reactions in the majority of trial participants.

-- 80% of both the low and full dose trial participants responded to the

vaccine which stimulated highly desirable anti-HIV T-cell (white

blood cell) and antibody responses.

-- More volunteers had antibody responses to the full dose than to the

1/10th dose vaccine, whereas response rates for T cells were similar

for the 1/10th and full dose.

-- 2nd MVA vaccination positively increased the number of CD8 T cell

responders and antibody responders.

-- Excellent results led to authorization to start two new trials with

GeoVax HIV/AIDS vaccines which began in June 2007.

-- In September, GeoVax responded to the announcement by Merck & Co., Inc.

that Merck's candidate AIDS vaccine failed to provide protection in a

human study designed to test for efficacy. In this Merck trial

involving high risk volunteers, an equal number of people received

either placebo or AIDS vaccine. The independent Data Safety Monitoring

Board recommended that the trial be stopped because it was not reaching

its efficacy endpoints. GeoVax responded to the discontinuance of

Merck's trial by pointing out significant differences between the

GeoVax vaccine technology and the technology used in the Merck trial.

GeoVax AIDS vaccines advancing in human trials represent a

significantly different vaccine approach, vaccine composition and

results to date than the Merck vaccine.

-- Prototypes for the GeoVax vaccines were selected from a series of

trials in non-human primates for their ability to protect against the

development of AIDS when vaccinated individuals were administered an

AIDS causing virus. At each major step along the development pathway,

GeoVax vaccines providing the best protection against AIDS were moved


-- GeoVax AIDS vaccines demonstrated excellent protective results in

non-human primate models, much better protective results than

reported for Merck's vaccine in similar models. GeoVax AIDS vaccines

protected 22/23 non-human primates for over 3 1/2 years and 5/6

non-vaccinated controls died of AIDS post-AIDS virus infection.

-- GeoVax AIDS vaccines are designed to elicit protective antibodies

(Ab) as well as protective T cells (white blood cells) against the

AIDS virus. The Merck vaccine stimulates only T cells for providing

protection and does not include the Env protein of HIV which is the

target for protective antibody (Ab).

-- Protective Ab has been difficult to elicit with HIV/AIDS vaccines.

GeoVax has approached this challenge by vaccinating with the natural

form of Env (HIV envelope antigens) under conditions that elicit

tightly binding Ab. GeoVax studies in non-human primates clearly show

this Ab correlates with protection.

-- GeoVax vaccines use an attenuated smallpox vaccine to provide pulses

of HIV proteins (antigen) to stimulate protective anti-AIDS vaccine

responses. Pulses of antigen from the GeoVax vaccines elicit T cell

responses that rapidly mobilize and then contract into a state called

"central memory" from which they rapidly expand to fight the

appearance of HIV.

-- In November, GeoVax announced excellent safety and immunogenicity data

from its full-dose HIV/AIDS vaccine human trial which began in

September 2006. This full-dose trial is the second in a series of four

Phase 1 human trials designed to test the safety and immunogenicity of

the GeoVax HIV/AIDS vaccines. Involving 36 participants of which 30

received vaccine and 6 received placebo, this trial protocol included

vaccination with two full-doses of GeoVax's DNA vaccine to prime the

immune response followed by two full-doses of GeoVax's MVA vaccine to

boost the immune response. GeoVax's DNA and MVA vaccines express over

50% 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 complete virus. A Phase 1 human trial,

started in April 2006, evaluated the delivery of only 1/10th of the

full dosage and utilized the same vaccine regimen evaluated in the full

dose trial.

From data collected from the 26 participants who completed the trial, the following positive conclusions were observed:
-- GeoVax HIV/AIDS vaccines, both DNA and MVA, continue to demonstrate

that they are quite safe and immunogenic following the delivery of

the four full-doses (two of each vaccine) used in the trial's


-- The full-dose regimen of GeoVax vaccines continues to be well

tolerated without any type of reaction, mild or systemic, in the

majority of participants.

-- CD4 T-cell responses are high in both the low and full-dose regimens,

84% and 78% of participants.

-- CD8 T-cell responses are present in 42% of the full-dose recipients

and 33% of the 1/10th dose recipients.

-- Antibody responses to the envelope glycoprotein (Env) increased

following the fourth vaccination, and were present in 88% of the

full-dose participants.

-- Delivery of the fourth vaccination increased the frequency and

magnitude of the CD8 T-cell and Antibody responses.

-- During November 2007 through January 2008, GeoVax raised approximately

$3 million in equity capital through a series of privately negotiated

transactions with individual accredited investors and one institutional

investor. These funds, along with the funds received pursuant to the

NIH grant discussed above will be used to offset the Company's ongoing

research and development costs and operating losses. GeoVax will

continue to seek additional financing through offerings of its equity


-- In February 2008, GeoVax announced the addition of company co-founder

Dr. Harriet Robinson to its staff as Vice President of Research &

Development. Dr. Robinson is known worldwide for her outstanding work

on retrovirus biology and development of DNA vaccines with special

emphasis on HIV/AIDS. Significant advances by GeoVax's HIV/AIDS vaccine

development program warrant Dr. Robinson's full time participation.

She has been instrumental in GeoVax's success through her HIV/AIDS

vaccine development activities while at Emory University and as Chief

Scientific Advisor to GeoVax. Dr. Robinson joined GeoVax part time in

November 2007 and became a full time employee in February 2008. By

focusing her efforts exclusively at GeoVax, Dr. Robinson intends to

speed up the vaccine development and human trial evaluation program

required to meet FDA regulatory requirements and future vaccine

commercialization efforts.

-- During February 2008, GeoVax announced that its Vaccine is only the 5th

AIDS Vaccine moving forward into Phase 2a human trials by the HIV

Vaccine Trials Network (HVTN), a network supported by the National

Institutes of Health (NIH). Most recently, GeoVax Senior Vice President

of Research & Development, Dr. Harriet Robinson, and President, Don

Hildebrand, attended a meeting with key HTVN officials in Seattle,

Washington to plan and prepare necessary documents for the next phase

of testing of GeoVax's promising HIV/AIDS vaccine, namely Phase 2a

human trials designated as Protocol # HVTN 205. The other four Vaccines

which had/or are participating in the HVTN human trials are designated

as Protocol # HVTN 201-204. GeoVax AIDS vaccine technology and

composition are significantly different than the Merck & Co. Inc. AIDS

vaccines that recently had their human trials halted due to safety and

effectiveness concerns.

About GeoVax Labs, Inc.

GeoVax Inc. is an Atlanta, Georgia USA biotechnology company, established to develop, manufacture, license and commercialize human vaccines for diseases caused by HIV-1 (Human Immunodeficiency Virus) and other infectious agents. GeoVax's vaccine technology is protected by 20 issued and filed patent applications.

For more information, contact the Company at (404) 727-0971 or visit

Safe Harbor Statement: All statements in this news release, not statements of historical fact, are forward-looking statements. These statements are based on expectations and assumptions as of the date of this press release and are subject to numerous risks and uncertainties which could cause actual results to differ materially from those described in the forward-looking statements. Risks and uncertainties include, but are not limited to, whether; GeoVax can develop and manufacture these vaccines with the desired characteristics in a timely manner, GeoVax's vaccines will be determined to be safe for use in humans, GeoVax's vaccines will be effective in preventing AIDS in humans, the vaccines will receive the regulatory approvals necessary to be licensed and marketed, GeoVax can raise the required capital to complete development of its vaccines, there is development of competitive products that may be more effective or easier to use than GeoVax's products, and other factors over which GeoVax has no control. GeoVax assumes no obligation to update these forward-looking statements, and does not intend to do so. Certain matters discussed in this news release are forward looking statements involving certain risks and uncertainties including, without limitation

SOURCE GeoVax Labs, Inc.
Copyright©2008 PR Newswire.
All rights reserved

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