via NewMediaWire -- GeoVax Labs, Inc. (NasdaqCM: GOVX), a
biotechnology company developing immunotherapies and vaccines
against infectious diseases and cancers, today announced its
financial results for the three months ended March 31, 2021.
GeoVax’s management will host a live conference
call and webcast at 4:30 p.m. Eastern Standard Time on Thursday,
May 6 to discuss financial results and provide a general business
update. Details are provided further below.
First Quarter 2021
Highlights
Capital Resources– On February 11, 2021, GeoVax
supplemented its cash resources through a $10.3 million follow-on
offering of common stock ($9.4 million net proceeds). During the
first quarter, the Company also received $3.2 million from the
exercise of outstanding warrants. Cash balances at March
31, 2021 were $20.8 million.
COVID-19 Vaccine– 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,” is supporting
the ongoing design, construction and preclinical testing of
our vaccine candidates in preparation for human clinical trials.
GeoVax is focused on a single-dose vaccine against multiple
COVID-19 variants that can be distributed with minimal/no
refrigeration, as reflected in recent announcements by the NIH and
other funding entities. Currently, GeoVax is conducting
animal testing of its “universal coronavirus vaccine” candidates,
from which the selection of a clinical development vaccine is
expected.
Intellectual Property– During the first
quarter of 2021, GeoVax filed international and U.S. patent
applications in its key focus areas of SARS-CoV-2 (COVID-19) and
cancer immunotherapy. The cancer immunotherapy
filingscover updates to the Company’s MVA viral vector technology
to amplify an immune response to a cancer antigen via vaccination,
which could strengthen its intellectual property position in this
space.
During April, GeoVax received a Notice of
Allowance from the U.S. Patent and Trademark Office for a
composition and method of use patent related to its HIV vaccine
program. The Company also received a Notice of Allowance for a
composition and method of use patent for its Hepatitis B vaccine
supported by a collaboration with Georgia State University.
Following these filings, GeoVax’s 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.
Management Commentary
David Dodd, GeoVax’s Chairman and CEO,
commented, “With the funding from our September 2020 offering and
subsequent financings in the first quarter of 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. The additional capital has allowed us to
make infrastructure and personnel investments, as well as funding
commitments in support of other programs. We are also
focusing on manufacturing process development for our MVA-produced
vaccines with a view toward cost-effective, large-scale production
for clinical and commercial distribution.
“We applaud the extraordinary COVID-19
vaccination efforts underway, and the rapid development of those
vaccines, but the worldwide scientific community recognizes the
reality that the fight is far from over. While we have
seen great advances in vaccines developed against SARS-CoV-2, the
coronavirus that causes COVID-19, variants of concern now pose a
threat to this progress. They spread rapidly, can reinfect people
who have been infected before, and they are rendering
countermeasures less effective.
“Additionally, coronaviruses in general have now
demonstrated their pandemic potential. SARS-CoV-2 is a type of
coronavirus (a Betacoronavirus) that also causes Severe Acute
Respiratory Syndrome (SARS) and Middle East Respiratory Syndrome
(MERS). The SARS and MERS coronaviruses are associated with case
fatality rates of 10%-35% (5-16 times worse than COVID-19) and we
know that coronaviruses circulate widely in animal reservoirs. The
emergence of a coronavirus combining the transmissibility of
COVID-19 with the lethality of SARS or MERS would be devastating to
civilization.
“GeoVax’s SARS-CoV-2 vaccine is based on our
GV-MVA-VLPTM technology, which enables insertion of multiple
COVID viral genes, potentially allowing for broad-spectrum virus
prevention. Unlike 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, and potentially provide
cross-reactive protection against other
coronaviruses. It is this broad-spectrum approach that
we believe warrants additional funding support once we complete the
ongoing small animal studies.
“Finally, we expect several data announcements
in the forthcoming weeks and months, most notably in our program
areas of COVID-19, Lassa Fever virus, Sudan/Marburg virus and
malaria. I look forward to sharing news of our progress as those
and other events occur,”concluded Mr. Dodd.
Financial Review
GeoVax reported a net loss for the three months
ended March 31, 2021 of $1,562,778, as compared to $595,694 for the
three months ended March 31, 2020.
Grant and collaboration revenues were $110,417
for the three months ended March 31, 2021, as compared to $715,977
for the same period in 2020. The 2021 period reflects amounts
related to our grant from NIH in support of our COVID-19 vaccine
program, while the 2020 period reflects amounts related to our
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 March 31, 2021, there is approximately
$355,000 of approved funds remaining and available for use related
to the COVID-19 and Lassa Fever grants.
Research and development (R&D) expenses were
$602,783 for the three months ended March 31, 2021 compared with
$808,936 for the comparable period in 2020, with the difference
primarily relating to the timing of expenses associated with
government grants. General and administrative (G&A) expenses
were $1,071,710 and $502,345 for the three months ended March 31,
2021 and 2020, respectively, with the increase primarily
attributable to higher Delaware franchise taxes, legal and patent
costs, consulting fees and personnel costs.
GeoVax reported cash balances of $20.8 million
at March 31, 2021, as compared to $9.9 million at December 31,
2020. Contributing to the increase in cash balances
during the first quarter were net proceeds of $9.4 million from the
sale of 1,644,000 shares of common stock, and $3.2 million from the
exercise of warrants to purchase 690,034 shares of common
stock.
Summarized financial information is attached.
Further information is included in the Company’s Quarterly Report
on Form 10-Q filed with the Securities and Exchange Commission.
Conference Call
Management will host a conference call at 4:30
p.m. ET on Thursday, May 6, 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 register for the call
via the following
link: https://dpregister.com/sreg/10155713/e7b7b09fcc
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/mediaframe/webcast.html?webcastid=8qJmr12T
A webcast replay of the call will be available
approximately one hour after the end of the call through August 6,
2021 and can be accessed through the above link. A telephonic
replay of the call will be available until May 20, 2021 and can be
accessed by calling 1-877-344-7529 using access code 10155713.
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
FINANCIAL TABLES FOLLOW
GEOVAX LABS, INC. |
Condensed Consolidated Statements of Operations
Information |
(amounts in thousands, except common share information) |
|
|
|
|
|
|
|
|
|
|
|
|
|
Three Months Ended |
|
|
|
|
|
March 31, |
|
|
|
|
|
|
2021 |
2020 |
Grant and collaboration revenues |
|
|
|
$ 110 |
$ 716 |
|
|
|
|
|
|
|
|
Operating expenses: |
|
|
|
|
|
|
Research and development |
|
|
|
603 |
809 |
|
General and administrative |
|
|
|
1,071 |
502 |
|
|
|
|
|
|
1,674 |
1,311 |
|
Loss from operations |
|
|
|
(1,564) |
(595) |
|
Other income (expense), net |
|
|
|
1 |
(1) |
|
|
|
|
|
|
|
|
Net loss |
|
|
|
$ (1,563) |
$ (596) |
|
|
|
|
|
|
|
|
Net loss per common share |
|
|
|
$ (0.29) |
$ (2.54) |
|
|
|
|
|
|
Weighted average common shares outstanding |
|
|
|
5,332,058 |
234,395 |
Condensed
Consolidated Balance Sheet Information |
(amounts in thousands, except common share information) |
|
|
|
|
|
March 31,2021 |
Dec. 31,2020 |
Assets: |
|
|
|
|
|
|
|
Cash and cash equivalents |
|
|
|
$ 20,843 |
$ 9,884 |
|
Other current assets |
|
|
|
118 |
351 |
|
Total current assets |
|
|
|
20,961 |
10,235 |
|
Property and other assets, net |
|
|
|
154 |
159 |
|
Total assets |
|
|
|
$ 21,115 |
$ 10,394 |
|
|
|
|
|
|
|
|
Liabilities and stockholders’ equity |
|
|
|
|
|
|
Total liabilities |
|
|
|
$ 464 |
$ 825 |
|
Stockholders’ equity |
|
|
|
20,651 |
9,569 |
|
Total liabilities and stockholders’ equity |
|
$ 21,115 |
$ 10,394 |
|
|
|
|
|
|
|
|
Common shares outstanding |
|
|
|
6,315,467 |
3,834,095 |
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