via NewMediaWire -- GeoVax Labs, Inc. (NasdaqCM: GOVX, GOVXW), a
biotechnology company developing immunotherapies and vaccines
against infectious diseases and cancers, today announced financial
results for the quarter ended September 30, 2020 and provided an
update on its corporate developments.
David Dodd, GeoVax’s Chairman & CEO,
commented, “Our corporate development activities during the third
quarter centered on securing the capital needed to advance our
product development, with a focus on our COVID-19 vaccine
and cancer immunotherapy programs. This culminated
on September 29 with the closing of our $12.8 million public
offering and listing of our common stock (GOVX) and warrants
(GOVXW) on Nasdaq.
“The GeoVax COVID-19 vaccine program is based on
our MVA-VLP technology which enables insertion of multiple antigen
fragments, potentially allowing for broad-spectrum virus
prevention. This differs from other technologies which only allow
for specific genetic fragments and therefore may result in a tight,
narrow focus of a single protein as the target. We believe
that the GeoVax approach has the potential to provide a stronger
and broader immune response without presenting an increased
infectious risk to the vaccinated individual, perhaps in a single
dose versus the multiple dosing anticipated from alternative
vaccine approaches.”
“We use the same technology for our
immuno-oncology program. Our cancer immunotherapy concept is
to combine a tumor-associated antigen vaccine with a potent
anti-tumor agent, such as an Immune Checkpoint Inhibitor (“ICI”),
with the goal of achieving regression of tumor growth and
development. The initial animal studies, based upon a
GeoVax-MUC1 vaccine/ICI combination have been encouraging, which is
why we’re focused in this area as one of our priorities.”
Though the primary use of proceeds from the
offering will be to accelerate development of the Company’s
COVID-19 vaccine and immuno-oncology programs, several other
programs continue to advance through partnering and collaborative
efforts, requiring minimal capital investment and additional
resources from the Company:
- The National Institute of Allergy and Infectious Diseases
(NIAID), part of the National Institutes of Health (NIH), is
funding a clinical trial which includes our HIV preventive
vaccine (GOVX-B11) through the HIV Vaccine Trials Network
(HVTN). We expect the next trial (HVTN-132) to begin in early
2021, which will further evaluate the safety and immunogenicity of
adding “protein boost” components to our vaccine.
- Through our mutual collaboration, American Gene Technologies
International, Inc. (AGT) intends to conduct a Phase 1 human
clinical trial with our combined technologies with the ultimate
goal of developing a functional cure for HIV
infection. We expect our vaccine to be added to an arm of
the AGT trial in 2021.
- A consortium led by researchers at the University of
California, San Francisco (UCSF) is using our vaccine as part of a
combinational therapy intended to induce remission in
HIV-positive individuals. This program entered clinical
trials in August 2020.
- Our Lassa Fever vaccine continues to progress
with funding under a cooperative agreement with the U.S. Department
of Defense. The project award supports generation of immunogenicity
and efficacy data for our vaccine candidate in both rodent and
nonhuman primate models, as well as manufacturing process
development and cGMP production of vaccine seed stock in
preparation for human clinical trials. This work is in
collaboration with U.S. Army Medical Research Institute of
Infectious Diseases (USAMRIID) and the Geneva Foundation.
- In August, we announced a multi-party collaboration for the
development of our Sudan ebolavirus (SUDV) and Marburg
virus (MARV) vaccine candidates. The collaboration between
us, researchers at the University of Texas Medical Branch (UTMB),
and Battelle Memorial Institute will utilize the suite of
preclinical services from NIAID. Under the collaboration, GeoVax’s
SUDV and MARV vaccine candidates will be tested for immunogenicity
and efficacy in the benchmark nonhuman primate model. The
studies will include two vaccine regimens -- single dose and
prime/boost immunization -- for each vaccine tested. This work
builds upon earlier studies in rodents and nonhuman primates for
our Ebola virus (EBOV) vaccine candidate that
demonstrated 100% protection against a lethal dose of EBOV upon a
single immunization and which were conducted with support from
NIAID and USAMRIID.
- We continue to collaborate separately with Leidos, Inc. and the
Burnet Institute for development of malaria
vaccine candidates using our GV-MVA-VLPTM vaccine
platform. Our collaboration with Leidos has been funded by a grant
to Leidos from the United States Agency for International
Development (USAID) Malaria Vaccine Development Program
(MVDP). The vaccine candidates have recently entered initial
animal testing with results expected as early as year-end
2020.
- All of our development programs are focused on areas of
significant medical need and commercial opportunities. Six of
the GeoVax vaccine programs (e.g., Ebola, Lassa, Marburg, Sudan,
Malaria and Zika) address medical areas within the FDA
Priority Review Voucher program, providing significant
potential value if any of them are successful.
Mr. Dodd concluded, “With the funding from our
September offering, we are progressing our COVID-19 vaccine program
while we continue to have discussions with various funding agencies
for more advanced and accelerated development toward human
testing. We also now have the flexibility to pursue a
clinical pathway for our immuno-oncology therapeutic effort and
seek new strategic options for expanding this program. These
opportunities allow us to potentially address significant unmet
medical needs and create value for our shareholders.”
Financial Results for the Period Ending
September 30, 2020
GeoVax reported a net loss of $570,648 for the
three months ended September 30, 2020, compared to a net loss of
$424,434 for the same period in 2019. For the nine months
ended September 30, 2020, the Company’s net loss was $1,621,546 as
compared to a net loss of $1,780,036 in 2019.
The Company reported grant and collaboration
revenues of $415,458 and $1,572,037 for the three-month and
nine-month periods of 2020, respectively, as compared to $333,209
and $907,382 reported for the comparable periods of 2019. These
amounts primarily relate to GeoVax’s grant from the U.S. Department
of Defense (DoD) for its Lassa Fever vaccine and its collaboration
with Leidos, Inc. for its malaria vaccine program. As of September
30, 2020, there were $417,121 of approved funds remaining and
available for use related to GeoVax’s grant from the DoD.
Research and development expenses were $416,756
and $1,687,113 for the three-month and nine-month periods of 2020,
respectively, as compared to $467,674 and $1,474,619 for the
comparable periods of 2019. Fluctuations in R&D
expenses from period to period are primarily attributable to the
timing of expenditures related to the DoD grant. General and
administrative expenses were $435,013 and $1,364,650 for the
three-month and nine-month periods of 2020, respectively, as
compared to $291,475 and $1,214,189 for the comparable periods of
2019.
GeoVax reported cash balances of $11,580,594 at
September 30, 2020, as compared to $283,341 at December 31, 2019.
Contributing to the increase in cash balances were the sale
of convertible preferred stock in January 2020 for proceeds of
$300,000, the issuance of a note payable in April 2020 for proceeds
of $170,200, the sale of convertible debentures in June 2020 for
net proceeds of $888,500, and net proceeds of approximately $11.2
million from the September 2020 offering. In connection with the
September offering, approximately $1.2 million of convertible
debentures and accrued interest were converted into the Company’s
equity securities. Additionally, $1.5 million of accumulated
amounts owed to the Company’s current and former executive officers
and directors were converted to equity.
Summarized financial information is included
below. Further information concerning the Company’s financial
position and results of operations are included in its Quarterly
Report on Form 10-Q filed with the Securities and Exchange
Commission.
Conference Call
Management will host a conference call at 8:15
a.m. ET on Friday, November 6, 2020 to review financial results and
provide an update on corporate developments. Following
management’s formal remarks, there will be a question and answer
session.
Participants are asked to pre-register for the
call via the following link:
https://dpregister.com/sreg/10149661/dc8783c368
Please note that registered participants will
receive their dial-in number upon registration and will dial
directly into the call without delay. Those without Internet
access or who are unable to pre-register may dial in by calling
1-866-777-2509 (domestic) or 1-412-317-5413 (international).
All callers should dial in approximately 10 minutes prior to the
scheduled start time and ask to be joined into the GeoVax Labs
call.
The conference call will be available through a
live webcast found here:
https://services.choruscall.com/links/govx201106.html
A webcast replay of the call will be available
approximately one hour after the end of the call through
February 6, 2021. The webcast replay can be accessed
through the above links or by calling 1-877-344-7529 (domestic) or
1-412-317-0088 (international) and using access code 10149661. The
telephonic replay will be available until November 20, 2020.
About GeoVax
GeoVax Labs, Inc. is a clinical-stage
biotechnology company developing human vaccines against infectious
diseases and cancer using a novel patented Modified Vaccinia
Ankara-Virus Like Particle (MVA-VLP) based vaccine platform. On
this platform, MVA, a large virus capable of carrying several
vaccine antigens, expresses proteins that assemble into VLP
immunogens within (in vivo) the person receiving the vaccine. The
production of VLPs in the person being vaccinated can mimic virus
production in a natural infection, stimulating both the humoral and
cellular arms of the immune system to recognize, prevent, and
control the target infection. The MVA-VLP derived vaccines can
elicit durable immune responses in the host similar to a
live-attenuated virus, while providing the safety characteristics
of a replication-defective vector.
GeoVax’s current development programs are
focused on preventive vaccines against COVID-19, HIV, Zika Virus,
hemorrhagic fever viruses (Ebola, Sudan, Marburg, and Lassa), and
malaria, as well as therapeutic vaccines against multiple cancers.
The Company has designed a preventive HIV vaccine candidate to
fight against the subtype of HIV prevalent in the commercial
markets of the Americas, Western Europe, Japan, and Australia;
human clinical trials for this program are managed by the HIV
Vaccine Trials Network (HVTN) with the support of the National
Institutes of Health (NIH). GeoVax’s HIV vaccine is also part of
two separate collaborative efforts to apply its innovative gene
therapy approach toward a functional cure for HIV.
Forward-Looking Statements
This release contains forward-looking statements
regarding GeoVax’s business plans and financial result. This
release and the related conference call discuss forward-looking
statements regarding GeoVax’s ability to implement its business
plan, expected revenues and future success. The words “believe,”
“may,” “estimate,” “continue,” “anticipate,” “intend,” “should,”
“plan,” “could,” “target,” “potential,” “is likely,” “will,”
“expect” and similar expressions, as they relate to us, are
intended to identify forward-looking statements. We have based
these forward-looking statements largely on our current
expectations and projections about future events and financial
trends that we believe may affect our financial condition, results
of operations, business strategy and financial needs. Actual
results may differ materially from those included in these
statements due to a variety of factors, including whether: GeoVax
can develop and manufacture its vaccines with the desired
characteristics in a timely manner, GeoVax’s vaccines will be safe
for human use, GeoVax’s vaccines will effectively prevent targeted
infections in humans, GeoVax’s vaccines will receive regulatory
approvals necessary to be licensed and marketed, GeoVax raises
required capital to complete vaccine development, there is
development of competitive products that may be more effective or
easier to use than GeoVax’s products, GeoVax will be able to enter
into favorable manufacturing and distribution agreements, the
impact of the COVID-19 pandemic continues, and other factors, over
which GeoVax has no control.
Further information on our risk factors is
contained in our most recent Quarterly Report on Form 10-Q
that we have filed with the SEC. Any forward-looking statement
made by us herein speaks only as of the date on which it is made.
Factors or events that could cause our actual results to differ may
emerge from time to time, and it is not possible for us to predict
all of them. We undertake no obligation to publicly update any
forward-looking statement, whether as a result of new information,
future developments or otherwise, except as may be required by
law.
Contact: GeoVax Labs,
Inc.investor@geovax.com678-384-7220
FINANCIAL TABLES FOLLOW
GEOVAX LABS, INC. |
Condensed Consolidated Statements of Operations
Information |
(amounts in thousands, except share and per share
information) |
|
|
|
|
Three Months Ended |
Nine Months Ended |
|
|
|
|
September 30, |
September 30, |
|
|
|
|
2020 |
2019 |
2020 |
2019 |
Grant
and collaboration revenue |
|
$ 415 |
$ 333 |
$ 1,572 |
$ 907 |
|
|
|
|
|
|
|
|
Operating expenses: |
|
|
|
|
|
|
Research and development |
|
417 |
468 |
1,687 |
1,475 |
|
General and administrative |
|
435 |
291 |
1,365 |
1,214 |
|
|
|
|
852 |
759 |
3,052 |
2,689 |
Loss
from operations |
|
(437) |
(426) |
(1,480) |
(1,781) |
Other
income (expense), net |
|
(134) |
2 |
(142) |
1 |
|
|
|
|
|
|
|
|
Net
loss |
|
$ (571) |
$ (424) |
$ (1,622) |
$ (1,780) |
|
|
|
|
|
|
|
|
Loss per
common share |
|
$ (0.73) |
$ (1,282.28) |
$ (2.85) |
$ (14,016.03) |
Condensed
Consolidated Balance Sheet Information |
(amounts in thousands, except share information) |
|
|
|
|
|
Sep. 30,2020 |
Dec. 31,2019 |
Assets: |
|
|
|
|
|
|
|
Cash
and cash equivalents |
|
|
|
$ 11,581 |
$ 283 |
|
Other
current assets |
|
|
|
154 |
164 |
|
Total
current assets |
|
|
|
11,735 |
447 |
|
|
|
|
|
|
|
|
|
Property and other assets, net |
|
|
|
21 |
22 |
|
Total
assets |
|
|
|
$ 11,756 |
$ 469 |
|
|
|
|
|
|
|
|
Liabilities and stockholders’ equity (deficiency) |
|
|
|
|
|
|
Total
liabilities |
|
|
|
$ 942 |
$ 2,043 |
|
Stockholders’ equity (deficiency) |
|
|
|
10,814 |
(1,574) |
|
Total
liabilities and stockholders’ equity (deficiency) |
|
$ 11,756 |
$ 469 |
|
|
|
|
|
|
|
|
Common
Shares Outstanding |
|
|
|
3,559,473 |
14,992 |
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