via NewMediaWire – GeoVax Labs, Inc. (Nasdaq: GOVX), a
biotechnology company developing immunotherapies and vaccines
against cancers and infectious diseases, today announced its
financial results for the third quarter ended September 30, 2022.
GeoVax’s management will host a live conference call and webcast
at 4:30 p.m. EST on Wednesday, November 9, 2022, to provide a
general business update and discuss financial results. Further
details are provided below.
THIRD QUARTER 2022 DEVELOPMENTS & PROGRESS
“Our unwavering focus is on the advancement of our GEO-CM04S1
and Gedeptin® clinical programs. To that end, we are expanding to
additional clinical sites and accelerating patient enrollment for
both programs,” said David Dodd, GeoVax’s Chairman and CEO. “We are
also delighted that we have secured rights to the NIH-MVA for
further development and commercial use against Monkeypox (MPX) and
Smallpox (SPX) viruses, which provides a compelling opportunity to
leverage our MVA-based vaccine expertise and help expand the global
public health supply options available for this ongoing worldwide
public health threat. Our successful financing activities during
the year provide us with adequate resources to advance these
programs, including the production of additional drug product for
use in these clinical trials. We are also now well-positioned to
advance the preclinical studies for our GEO-CM02 pan-coronavirus
vaccine candidate and our MVA-VLP-MUC1 cancer immunotherapy program
to further solidify our promising pipeline of human vaccines and
immunotherapies.”
CORONAVIRUS VACCINES
GeoVax has been focused on advancing its two Phase 2 clinical
studies of GEO-CM04S1 against COVID-19, one as a primary vaccine
for immunocompromised cancer patients, in direct comparison to the
Pfizer mRNA vaccine (NCT04977024), and the second as a booster for
healthy patients who have previously received either the Pfizer or
Moderna vaccine as their initial inoculation (NCT04639466). During
the November 9th Corporate Update call, GeoVax will provide a
progress report on study expansion developments.
Earlier this year, data from a Phase 1 study of GEO-CM04S1 were
published in the The Lancet Microbe. This peer-reviewed publication
(accessible here) reports data showing that GEO-CM04S1 produced
robust neutralizing antibodies and T cells against SARS-CoV-2 with
no significant side effects. These data confirm the powerful dual
action of the GeoVax vaccine, an important feature given the
multiple spike antigen mutations, leading to variants of concern
and inconsistent protection from existing FDA-approved vaccines.
Should a new mutation arise in the spike antigen that interferes
with antibody recognition, a person vaccinated with GEO-CM04S1 may
still have substantial T-cell immunity against both the
nucleocapsid and spike antigens.
In July, additional analyses of data from the Phase 1 study of
GEO-CM04S1 published in the peer-reviewed journal, iScience
(accessible here) show that GEO-CM04S1 demonstrated potent and
equivalent T-cell cross-reactivity against Delta and Omicron
variants. These findings suggest that T-cell immunity stimulated by
GEO-CM04S1 may constitute a critical second line of defense to
provide long-term protection against SARS-CoV-2 variants. Further
details and potential implications of these findings will also be
discussed on the November 9th update call.
Building on earlier findings, during the third quarter GeoVax
also initiated new preclinical studies of its pan-coronavirus
vaccine candidate (GEO-CM02) to prepare for an Investigational New
Drug (IND) application and subsequent human clinical trials as a
potential single-dose universal coronavirus vaccine.
IMMUNO-ONCOLOGY DEVELOPMENTS
A Phase 1/2 trial (NCT03754933) evaluating the safety and
efficacy of repeat cycles of Gedeptin® therapy in patients with
recurrent head and neck squamous cell carcinoma (HNSCC) has
broadened from a single site at Stanford University to additional
sites at Emory University and Thomas Jefferson University. Funded
in part by the US Food & Drug Administration under its Orphan
Products Clinical Trials Grants Program, the trial will guide the
design of a larger study that also may involve patients with other
anatomically accessible oral and pharyngeal cancers, including
cancers of the lip, tongue, gum, floor of mouth, salivary gland and
other oral cavities.
To further evaluate the Company’s additional immunotherapy
candidate for solid tumors (MVA-VLP-MUC1), GeoVax recently began a
preclinical study with Dr. Pinku Mukherjee at the University of
North Carolina at Charlotte, to define the optimal course and
schedule of vaccination for incorporation into a Phase 1 clinical
protocol.
HEMORRHAGIC FEVER VIRUS VACCINES
In July 2022, GeoVax announced the publication of a
peer-reviewed animal efficacy study of its modified vaccinia Ankara
(MVA) vectored vaccine against Sudan ebolavirus (SUDV) in Nature
Partner Journals (NPJ) Vaccines (accessible here). The anticipated
final stage of preclinical testing involving nonhuman primates has
recently been completed and results are expected to be discussed
during upcoming scientific conferences during the fourth quarter of
this year.
MODIFIED VACCINIA ANKARA (MVA) & MONKEYPOX
MVA is the vaccine vector utilized by GeoVax in a number of its
vaccine candidates, including those for COVID-19, various
hemorrhagic fever viruses, the GeoVax MVA-VLP-MUC1 cancer
immunotherapy and others. Importantly, MVA is also the
vaccine used and stockpiled for immunization against the MPX and
SPX viruses.
In response to the global need to address the continued emerging
threat from MPX and the unique opportunity offered by MVA-based
vaccines, GeoVax recently secured rights from the NIH covering
preclinical, clinical and commercial uses of the NIH-MVA against
MPX or SPX viruses. The Company is now evaluating development and
regulatory pathways towards expanding the public health options
available to reduce and manage the risk of MPX worldwide.
GeoVax previously demonstrated that an experimental HIV vaccine,
utilizing NIH-MVA as the vaccine vector, protected non-human
primates challenged with a lethal dose of the MPX virus three years
post vaccination (publication accessible here). In August 2022, the
City of Hope team, which originally developed GEO-CM04S1, published
results demonstrating that both their proprietary sMVA (synthetic
MVA) and GEO-CM04S1, which utilizes sMVA as the vaccine vector,
(referred to as “COH04S1” in the publication, accessible here)
elicited robust orthopoxvirus-specific binding and neutralizing
antibody responses. They also reported that healthy adults,
vaccinated with COH04S1 at different dose levels, developed robust
orthopoxvirus-specific humoral and cellular immune responses that
are durable for over six months post-vaccination. The authors
conclude that “COH04S1 and sMVA represent unique vaccine candidates
to control the unforeseen global MPXV outbreak.”
FINANCIAL REVIEW
GeoVax reported a net loss of $3,968,102 ($0.17 per share) for
the three months ended September 30, 2022, compared to a net loss
of $1,950,503 ($0.31 per share) for the same period in 2021. For
the nine months ended September 30, 2022, the Company’s net loss
was $8,637,316 ($0.63 per share) as compared to a net loss of
$4,827,314 ($0.80 per share) in 2021.
Research and development expenses were $2,721,196 and $5,358,917
for the three-month and nine-month periods of 2022, respectively,
as compared to $1,224,362 and $2,659,980 for the comparable periods
of 2021, with the increases primarily due to higher personnel and
consulting costs, costs of conducting clinical trials for
GEO-CM04S1 and Gedeptin and costs of manufacturing materials for
use in clinical trials.
General and administrative expenses were $1,249,337 and
$3,363,672 for the three-month and nine-month periods of 2022,
respectively, as compared to $757,432 and $2,562,541 for the
comparable periods of 2021, with the increases primarily
attributable to higher personnel costs and consulting costs, patent
costs, investor relations costs and travel costs, all associated
with a generally higher level of activity during 2022.
GeoVax reported cash balances of $34.7 million on September 30,
2022, as compared to $11.4 million on December 31, 2021.
Contributing to the increase in cash balances during the nine-month
period were aggregate net proceeds of $27.7 million from sales of
our common stock and warrants during January and May, and $7.6
million from the exercise of warrants during August.
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, scheduled to begin at
4:30 p.m. EST today, November 9, 2022, to review financial results
and provide an update on corporate developments. Following
management’s formal remarks, there will be a question-and-answer
session.
Domestic: 877-269-7756
International: 201-689-7817
Conference ID: 13733113
Webcast: GeoVax Earnings Webcast
A webcast replay of the call will be available via the same link
as the live webcast approximately one hour after the end of the
call through February 9, 2023. A telephonic replay of the call can
be accessed by calling 877-660-6853 (domestic) or 201-612-7415
(international), using access code 13733113. The telephonic replay
will be available until November 23, 2022.
About GeoVax
GeoVax Labs, Inc. is a clinical-stage biotechnology company
developing novel therapies and vaccines for cancers and many of the
world’s most threatening infectious diseases. The company’s lead
program in oncology is a novel oncolytic solid tumor gene-directed
therapy, Gedeptin®, presently in a multicenter Phase 1/2 clinical
trial for advanced head and neck cancers. GeoVax’s lead infectious
disease candidate is GEO-CM04S1, a next-generation COVID-19 vaccine
targeting high-risk immunocompromised patient populations.
Currently in two Phase 2 clinical trials, GEO-CM04S1 is being
evaluated as a single-dose COVID-19 vaccine for immunocompromised
patients such as those suffering from hematologic cancers and other
patient populations for whom the current authorized COVID-19
vaccines are insufficient. In addition, GEO-CM04S1 is in a Phase 2
clinical trial evaluating the vaccine as a more robust, durable
COVID-19 booster among healthy patients who previously received the
mRNA vaccines. GeoVax has a leadership team who has driven
significant value creation across multiple life science companies
over the past several decades. For more information, visit our
website: www.geovax.com.
Forward-Looking Statements
This release contains forward-looking statements regarding
GeoVax’s business plans. The words “believe,” “look forward to,”
“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
is able to obtain acceptable results from ongoing or future
clinical trials of its investigational products, GeoVax’s
immuno-oncology products and preventative vaccines can provoke the
desired responses, and those products or vaccines can be used
effectively, GeoVax’s viral vector technology adequately amplifies
immune responses to cancer antigens, GeoVax can develop and
manufacture its immuno-oncology products and preventative vaccines
with the desired characteristics in a timely manner, GeoVax’s
immuno-oncology products and preventative vaccines will be safe for
human use, GeoVax’s vaccines will effectively prevent targeted
infections in humans, GeoVax’s immuno-oncology products and
preventative vaccines will receive regulatory approvals necessary
to be licensed and marketed, GeoVax raises required capital to
complete 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, and other factors, over which GeoVax has
no control.
Further information on our risk factors is contained in our
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.
Media Relations Contact:Gina Cestari6
Degrees917-797-7904gcestari@6degreespr.com
Investor Relations Contact:Rich CockrellCG
Capital404-736-3838govx@cg.capital
GEOVAX LABS,
INC. |
Condensed
Consolidated Statements of Operations Information |
(amounts in
thousands, except per share data) |
|
|
|
|
Three Months
Ended |
Nine Months
Ended |
|
|
|
|
September 30, |
September 30, |
|
|
|
|
|
2022 |
|
|
2021 |
|
|
2022 |
|
|
2021 |
|
Grant and collaboration revenue |
|
$ |
- |
|
$ |
30 |
|
$ |
82 |
|
$ |
221 |
|
|
|
|
|
|
|
|
|
Operating expenses: |
|
|
|
|
|
|
Research and development |
|
|
2,721 |
|
|
1,224 |
|
|
5,359 |
|
|
2,660 |
|
|
General and administrative |
|
|
1,249 |
|
|
758 |
|
|
3,364 |
|
|
2,563 |
|
|
|
|
|
|
3,970 |
|
|
1,982 |
|
|
8,723 |
|
|
5,223 |
|
Loss from operations |
|
|
(3,970 |
) |
|
(1,952 |
) |
|
(8,641 |
) |
|
(5,002 |
) |
Other income (expense), net |
|
|
2 |
|
|
1 |
|
|
4 |
|
|
175 |
|
|
|
|
|
|
|
|
|
Net loss |
|
$ |
(3,968 |
) |
$ |
(1,951 |
) |
$ |
(8,637 |
) |
$ |
(4,827 |
) |
|
|
|
|
|
|
|
|
Loss per common share |
|
$ |
(0.17 |
) |
$ |
(0.31 |
) |
$ |
(0.63 |
) |
$ |
(0.80 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Condensed
Consolidated Balance Sheet Information |
(amounts in
thousands) |
|
|
|
|
|
|
|
|
|
|
|
Sep. 30, 2022 |
Dec. 31, 2021 |
|
|
|
|
|
|
Assets: |
|
|
|
|
|
|
|
|
Cash and cash equivalents |
|
|
|
$ |
34,677 |
|
$ |
11,424 |
|
|
Other current assets |
|
|
|
|
1,460 |
|
|
205 |
|
|
Total current assets |
|
|
|
|
36,137 |
|
|
11,629 |
|
|
Property and other assets, net |
|
|
|
2,433 |
|
|
168 |
|
|
Total assets |
|
|
|
$ |
38,570 |
|
$ |
11,797 |
|
|
|
|
|
|
|
Liabilities and stockholders’ equity |
|
|
|
|
|
|
Total liabilities |
|
|
$ |
6,789 |
|
$ |
7,435 |
|
|
Stockholders' equity |
|
|
|
31,781 |
|
|
4,362 |
|
|
Total liabilities and stockholders' equity |
|
|
$ |
38,570 |
|
$ |
11,797 |
|
|
|
|
|
|
|
|
Common shares outstanding |
|
|
|
|
26,334 |
|
|
6,382 |
|
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