via NewMediaWire -- GeoVax Labs, Inc. (NasdaqCM: GOVX), a
biotechnology company developing immunotherapies and vaccines
against infectious diseases and cancer, today announced its
financial results for the year ended December 31, 2020.
GeoVax’s management will host a live conference
call and webcast at 8:00 a.m. Eastern Standard Time on Wednesday,
March 24 to discuss financial results and provide a general
business update. Details are provided further below.
GeoVax Program Updates and Other
Highlights
COVID-19 Vaccine– Our SARS-CoV-2 (COVID-19)
vaccine is based on our GV-MVA-VLPTM technology, which enables
insertion of multiple antigen fragments, potentially allowing for
broad-spectrum virus prevention. Unlike certain competitor vaccines
that target only the COVID-19 spike protein, our vaccines are
designed to provoke a response to multiple COVID-19 antigens, which
means our vaccines could be less susceptible to viral mutations.
Our vaccines are intended to be used as either a primary vaccine or
to boost other COVID-19 vaccines as part of vaccination strategies
to provide immunity to a range of SARS-CoV-2 variants.
In January 2021, the National Institute of
Allergy and Infectious Diseases (NIAID), part of the National
Institutes of Health (NIH), awarded GeoVax a Small Business
Innovative Research (SBIR) grant in support of our development of a
COVID-19 vaccine. The Phase 1 grant, titled,
“Preclinical Development of GV-MVA-VLP Vaccines Against COVID-19,”
will support the ongoing design, construction and
preclinical testing of our vaccine candidates in preparation
for human clinical trials.
Immuno-Oncology Program– Our cancer
immunotherapy program is based on the concept of combining 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. In February 2021, we filed a U.S. patent
application, covering updates to our MVA viral vector technology to
amplify an immune response to a cancer antigen via vaccination,
which could strengthen our intellectual property position in this
space. Following our recent fund-raising activities,
immuno-oncology is an important focus area for the Company and we
are engaging with multiple collaborators. We expect to provide
further details on our progress and plans to advance to human
clinical testing in the near future.
Hemorrhagic Fever Vaccine Programs
- Lassa Fever– We continue to progress with grant funding
from the U.S. Department of Defense for our Lassa Fever (LASV)
vaccine program. 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. We expect to announce results from this work
during the first half of 2021.
- Sudan ebolavirus and Marburg virus– In August 2020, we
announced a multi-party collaboration for the development of our
Sudan ebolavirus (SUDV) and Marburg virus (MARV) vaccine
candidates. The collaboration between GeoVax, researchers at the
University of Texas Medical Branch (UTMB), and Battelle Memorial
Institute is utilizing the suite of preclinical services from
NIAID. Under the collaboration, GeoVax’s SUDV and MARV vaccine
candidates are being tested for immunogenicity and efficacy in the
benchmark nonhuman primate model. This work builds
uponearlier 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. We expect to announce results from this
work during the first half of 2021.
Malaria Vaccine– We continue to collaborate
separately with Leidos, Inc. and the Burnet Institute in
development of malaria vaccine candidates using our
GV-MVA-VLPTM vaccine platform. The 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). Several vaccine candidates have recently
entered initial animal testing with results expected during the
first half of 2021.
HIV Vaccine Programs
- HIV Preventive Vaccine– NIAID is funding a
clinical trial that includes our HIV preventive vaccine (GOVX-B11)
through the HIV Vaccine Trials Network (HVTN). The next
trial (HVTN 132) has been delayed due to COVID-19, but we expect it
to begin in late 2021. HVTN 132 will further evaluate
the safety and immunogenicity of adding “protein boost” components
to the GOVX-B11 vaccination regimen.
- HIV Immunotherapy– We are part of two separate
efforts to develop a combination therapy to induce remission in
HIV-positive individuals (a “functional cure”). In August 2020, a
consortium led by researchers at the University of California, San
Francisco (UCSF), began enrolling patients in a Phase 1 human
clinical trial using our vaccine as part of a combination therapy
intended to induce remission in HIV-positive individuals. In
September 2020, American Gene Technologies International, Inc.
(AGT) began enrolling patients in a Phase 1 clinical trial
evaluating its gene therapy technology in this area; we expect our
vaccine to be added to an arm of the AGT trial during 2021.
Licenses and Intellectual Property
In October 2020, we signed a license
agreement with NIAID allowing us to use the materials and patent
rights owned by agencies of the United States Department of Health
and Human Services (HHS) in combination with our proprietary
technology for the creation of a preventive vaccine that primes
and/or boosts the immune system against COVID-19. The agreement
provides GeoVax with nonexclusive rights to develop, manufacture
and commercialize our COVID-19 vaccine.
In November 2020, we signed another license
agreement with NIAID in support of our non-clinical development of
preventive and/or therapeutic vaccines against numerous pathogens
including Ebola-Zaire, Ebola-Sudan, Lassa virus, Marburg virus,
Zika virus and malaria. The agreement also extends to our research
and development efforts in certain oncology areas.
In February 2021, we filed international and U.S.
patent applications in our key focus areas of SARS-CoV-2 (COVID-19)
and cancer immunotherapy. Following these filings, our
wholly owned, co-owned, and in-licensed intellectual property
portfolio now stands at over 70 granted or pending patent
applications spread over 20 patent families.
Capital Resources
In September 2020, we completed a public offering
of our common stock (GOVX) and publicly traded warrants (GOVXW)
with net proceeds of $11.2 million. Our cash balance at
December 31, 2020 was $9.9 million at December 31, 2020, as
compared to $283,341 at the end of 2019.
During the first quarter of 2021, we further
supplemented our cash resources with net proceeds of $9.4 million
from a follow-on offering of our common stock, and $3.2 million
from the exercise of outstanding warrants. We therefore expect
to report total cash balances in excess of $20 million at the end
of the first quarter of 2021.
Management Commentary
David Dodd, GeoVax’s Chairman & CEO,
commented, “With the funding from our September offering and
subsequent financing in early 2021, we are well-positioned to
advance several of our development programs, with a continued focus
on our COVID-19 vaccine and our cancer immunotherapy programs. As
mentioned in this release, we expect several data announcements
during the first half of this year, and I look forward to sharing
news of our progress as those events occur.”
Financial Review
GeoVax reported a net loss for the year ended
December 31, 2020 of $3.0 million, as compared to $2.4 million for
the year ended December 31, 2019.
Grant and collaboration revenues were $1.8 million
for 2020, as compared to $1.2 million in 2019. These amounts
primarily relate to GeoVax’s grant from the U.S. Department of
Defense (DoD) for our Lassa Fever vaccine and our collaboration
with Leidos, Inc. for its malaria vaccine program. As of December
31, 2020, there were $165,500 of approved funds remaining and
available for use related to GeoVax’s grant from the DoD.In January
2021, NIAID awarded a $299,927 SBIR grant to the Company in support
of its COVID-19 vaccine program which will support the ongoing
design, construction and preclinical testing of vaccine
candidates in preparation for human clinical trials.
Research and development expenses were $2.4
million for 2020, as compared to $1.9 million in 2019. General and
administrative expenses were $2.2 million for 2020, as compared to
$1.6 million in 2019. Fluctuations in R&D expenses from period
to period are primarily attributable to the timing of expenditures
related to the DoD grant. Other income (expense) was
($141,253) for 2020, as compared to $1,864 in 2019, with 2020
including $138,851 of interest expense and amortized debt discount
related to convertible debentures that were retired during the
year.
GeoVax reported cash balances of $9.9 million at
December 31, 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 under
terms substantially the same as those offered to the public. During
the first quarter of 2021, the Company further supplemented its
cash resources with net proceeds of $9.4 million from a follow-on
offering of its common stock, and $3.2 million from the exercise of
outstanding warrants.
Summarized financial information is attached.
Further information concerning the Company’s financial position and
results of operations are included in its Annual Report on Form
10-K filed with the Securities and Exchange Commission.
Conference Call
Management will host a conference call at 8:00
a.m. ET on Wednesday, March 24, 2021 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/10152894/e3a3a9bd2c
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/govx210324.html
A webcast replay of the call will be available
approximately one hour after the end of the call through June 24,
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. A telephonic replay
of the call can be accessed by calling 1-877-344-7529 and will be
available until April 7, 2021.
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 in 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 and the related conference call
contain forward-looking statements regarding GeoVax’s business
plans and financial results. 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 and its collaborators are able to
complete their work within the expected timeframes, GeoVax is able
to obtain the patent protection sought, GeoVax’s COVID-19 vaccines
can provoke responses to multiple COVID-19 antigens, and those
vaccines can be used effectively as a primary or booster to other
COVID-19 vaccines, GeoVax’s viral vector technology adequately
amplifies immune responses to cancer antigens, 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 registration statement on Form S-3 and the
periodic reports on Form 10-Q and Form 10-K that we have filed and
will file 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
GEOVAX LABS, INC. |
Condensed Consolidated Statements of Operations
Information |
(amounts in thousands, except common share information) |
|
|
|
|
|
|
|
|
|
|
|
|
|
Year EndedDecember 31, |
|
|
|
|
|
|
2020 |
2019 |
Grant and collaboration revenue |
|
|
|
$ 1,823 |
$ 1,176 |
|
|
|
|
|
|
|
|
Operating expenses: |
|
|
|
|
|
|
Research and development |
|
|
|
2,444 |
1,911 |
|
General and administrative |
|
|
|
2,196 |
1,637 |
|
|
|
|
|
|
4,640 |
3,548 |
|
Loss from operations |
|
|
|
(2,817) |
(2,372) |
|
Other income (expense), net |
|
|
|
(141) |
2 |
|
|
|
|
|
|
|
|
Net loss |
|
|
|
$ (2,958) |
$ (2,371) |
|
|
|
|
|
|
|
|
Net loss per common share |
|
|
|
$ (2.14) |
$ (781.87) |
|
|
|
|
|
|
Weighted average shares outstanding |
|
|
|
1,383,523 |
3,032 |
Condensed Consolidated Balance Sheet
Information |
(amounts in thousands, except common share information) |
|
|
|
|
|
December 31, |
|
|
|
|
|
2020 |
2019 |
Assets: |
|
|
|
|
|
|
|
Cash and cash equivalents |
|
|
|
$ 9,884 |
$ 283 |
|
Other current assets |
|
|
|
351 |
164 |
|
Total current assets |
|
|
|
10,235 |
447 |
|
Property and other assets |
|
|
|
159 |
22 |
|
Total assets |
|
|
|
$ 10,394 |
$ 469 |
|
|
|
|
|
|
|
|
Liabilities and stockholders’ equity |
|
|
|
|
|
|
Total liabilities |
|
|
|
$ 825 |
$ 2,043 |
|
Stockholders’ equity (deficiency) |
|
|
|
9,569 |
(1,574) |
|
Total liabilities and stockholders’ equity |
|
$ 10,394 |
$ 469 |
|
|
|
|
|
|
|
|
Common Shares Outstanding |
|
|
|
3,832,892 |
14,992 |
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