via NewMediaWire -- GeoVax Labs, Inc. (NasdaqCM: GOVX), a
biotechnology company developing vaccines and immunotherapies
against infectious diseases and cancers, today announced its
financial results for the quarter ended June 30, 2022.
GeoVax’s management will host a live conference
call and webcast at 4:30 p.m. Eastern Standard Time on Wednesday,
August 3 to provide a general business update and discuss financial
results. Details are provided further below.
Six Month 2022 Highlights
COVID-19 VACCINE DEVELOPMENTS &
PROGRESS
Phase 2 Trials –
GEO-CM04S1 – GEO-CM04S1 is being studied in a Phase 2
clinical trial (NCT04977024) as a primary vaccine for
immunocompromised cancer patients who have difficulty producing
antibodies and largely depend on T cells to protect against the
virus responsible for COVID-19. In this study, CM04S1 is being
directly evaluated in comparison to the Pfizer/BioNTech mRNA
authorized vaccine.
GEO-CM04S1 is also being evaluated in a Phase 2
vaccine booster trial format (NCT04639466), which is aimed at
evaluating how GEO-CM04S1 may boost pre-existing vaccine
immunity to spike while also inducing a strong immune response to
nucleocapsid. GEO-CM04S1 is unique to other COVID-19 vaccines in
that it targets both the spike and nucleocapsid proteins. In
contrast, the current U.S. Food and Drug Administration-approved
COVID-19 vaccines only target the spike protein.
During the second quarter of 2022, the
Investigational New Drug (IND) applications for each of these
clinical trials were successfully transferred from City of Hope to
GeoVax, and GeoVax is now focused on accelerating patient
enrollment for the studies.
In March 2022, data from a Phase 1 study
of GEO-CM04S1 (formerly known as COH04S1) were published
in the peer-reviewed journal, The Lancet
Microbe. The 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 mutations in
spike, 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 our vaccine may still have substantial T
cell immunity against both the nucleocapsid and spike antigens.
More recently, 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.
Pan-Coronavirus Vaccine (GEO-CM02) –
In addition to the clinical programs for GEO-CM04S1 for COVID-19,
GeoVax continued to assess GEO-CM02 as a potential single-dose
universal coronavirus vaccine during the first quarter. This
program was supported by a Small Business Innovation Research
(SBIR) grant from the NIH during 2021. In small animal studies, the
Company measured functional immune responses after a single dose
that mediated protection from infection and pathogenesis, including
protection against the more virulent Beta variant.
GeoVax recently initiated additional preclinical
studies to prepare for IND filing and subsequent human clinical
trials.
IMMUNO-ONCOLOGY DEVELOPMENTS &
PROGRESS
Phase 1/2 Trial – Gedeptin® – 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) that have tumor(s)
accessible for injection and no curable treatment options, is
ongoing at Stanford University in collaboration with Emory
University. The trial design involves repeat administration using
Gedeptin, followed by systemic fludarabine, to gain additional
information prior to expansion towards a larger patient trial. The
initial stage of the study is being funded by the FDA under its
Orphan Products Clinical Trials Grants Program. The FDA has
also granted GedeptinOrphan Drug Status for the intra-tumoral
treatment of anatomically accessible oral and pharyngeal cancers,
including cancers of the lip, tongue, gum, floor of mouth, salivary
gland and other oral cavities.
This trial is currently being expanded to a
multi-site trial with a focus on accelerated patient
enrollment.
MVA-VLP-MUC1 for Solid Tumor
Cancers – In March, GeoVax announced that the U.S. Patent
and Trademark Office issued Patent No. 11278607, pursuant to the
Company’s patent application No. 16/068,527 titled, “Compositions
and Methods for Generating an Immune Response to a Tumor Associated
Antigen.” The claims granted by the patent generally cover
GeoVax’s vector platform for expressing tumor associated antigens
in virus-like particles (VLPs) from a Modified Vaccinia Ankara
(MVA) viral vector and encompass GeoVax’s Mucin 1 (MUC1)
tumor-associated antigen immunotherapy candidate. The Company uses
its GV-MVA-VLPTM vaccine platform to express abnormal,
aberrantly glycosylated forms of the cell surface-associated MUC1
protein that is associated with a wide range of cancers, including
breast, colon, ovarian, prostate, pancreatic, and lung.
GeoVax recently began an animal study with Dr.
Pinku Mukherjee at the University of North Carolina at Charlotte to
define the optimal course and schedule of vaccination to define a
protocol that can be evaluated in a Phase 1 clinical trial for the
Company’s MVA-VLP-MUC1 immunotherapy candidate.
HEMORRHAGIC FEVER VIRUS VACCINES DEVELOPMENT
& PROGRESS
In July, GeoVax announced the publication of a
peer-reviewed animal efficacy study of its modified vaccine Ankara
(MVA) vectored vaccine against Sudan ebolavirus (SUDV)
in Nature Partner Journals (NPJ) Vaccines. GeoVax’s vaccine,
MVA-VLP-SUDV, combines the advantages of the immunogenicity of a
live attenuated vaccine vector with the authentic conformation of
VLPs. The vaccine expresses minimal components to generate
self-assembling VLPs in the vaccinee: the envelope glycoprotein GP
and the matrix protein VP40. Guinea pigs vaccinated with one dose
of MVA-VLP-SUDV generated SUDV-specific binding and neutralizing
antibody responses as well as Fc-mediated protective effects. These
responses were boosted by a second vaccine dose. All vaccinated
animals which received either one or two vaccine doses were
protected from death and disease symptoms following challenge with
a lethal dose of SUDV. These data demonstrate single dose
protection and potency of the MVA-VLP platform for use in emergency
situations to contain outbreaks. The next stage of
testing involving nonhuman primates is nearing completion.
MODIFIED VACCINIA ANKARA (MVA) &
MONKEYPOX
The vaccine used and stockpiled for immunization
against Monkeypox is MVA, which is also the vaccine vector utilized
in numerous GeoVax vaccines targeting COVID-19, Hemorrhagic fever
viruses (e.g., Sudan ebolavirus and Zaire ebolavirus), HIV, Zika
and the GeoVax MVA-VLP-MUC1 cancer
immunotherapy. Previous peer-reviewed publications
reviewed the successful prevention of Monkeypox in non-human
primate models by GeoVax MVA-based HIV vaccines:
- Earl, P.L., Americo, J.L., Wyatt, L.S., Anne Eller, L.,
Montefiori, D.C., Byrum, R., Piatak, M., Lifson, J.D., Rao Amara,
R., Robinson, H.L., Huggins, J.W., Moss, B. Recombinant
modified vaccinia virus Ankara provides durable protection against
disease caused by an immunodeficiency virus as well as long-term
immunity to an orthopoxvirus in a non-human
primate. Virology 15:84-97, 2007.
- Nigam, P., Earl, P.L., Americo, J.L., Sharma, S., Wyatt, L.S.,
Edghill-Spano, Y., Chennareddi, L., Silvera, P., Moss, B.,
Robinson, H.L., Amara, R.R. DNA/MVA HIV-1 AIDS vaccine
elicits long-lived vaccinia virus-specific immunity and confers
protection against a lethal monkeypox
challenge. Virology 366:73-83.
Currently, evaluation is underway related to
GEO-CM04S1 and the prevention of Monkeypox. It is anticipated
that the results will demonstrate successful protection, validating
that GEO-CM04S1 is protective against both COVID-19 and
Monkeypox. GeoVax also anticipates validating its
hemorrhagic fever virus vaccines as protective against Monkeypox,
potentially providing unique vaccines preventing both hemorrhagic
fever virus and Monkeypox virus in a single
vaccine.
OPERATIONAL RESOURCES STRENGTHENED
During the first six months of 2022, GeoVax
strengthened its organizational and operational resources in
several areas to support our advancement through clinical
development and regulatory registration. These
included:
- the appointment of Kelly T. McKee, Jr., M.D., M.P.H., to serve
as Chief Medical Officer.
- the appointment of Jeffrey Welch to serve as Head, Process
Development and Manufacturing Operations.
- the appointment of John W. Sharkey, Ph.D. to serve as Vice
President, Business Development.
- the full-time engagement of Mark J. Newman, Ph.D. as Chief
Scientific Officer. Dr. Newman previously worked on a
part-time basis.
- the creation and staffing of two new positions: Director,
Clinical Operations (Erica Raiden) and Director, Project Management
(Ashley Zuniga, Ph.D.), both key to effective management of our
expanded operations.
- the engagement of Allucent (formerly known as CATO SMS) to
manage the ongoing Phase 1/2 trial of Gedeptin® therapy
in patients with recurrent head and neck squamous cell
carcinoma.
- the further engagement of Allucent to manage the two
ongoingPhase 2 clinical trials of GEO-CM04S1, against
SARS-CoV-2.
CAPITAL RESOURCES STRENGTHENED
In May, GeoVax added to its cash resources
through a follow-on offering and private placementof common stock
and warrants with net proceeds of approximately $18.5 million,
supplementing the $9.2 million raising in January
2022. GeoVax’s cash balances at June 30, 2022 stood at $30.9
million.
Management Commentary
David Dodd, GeoVax’s Chairman and CEO,
commented, “Our corporate priorities continue to be the clinical
programs for SARS-CoV-2 and Gedeptin and we are focused on
expanding the clinical sites for these trials and accelerating
patient enrollment. The May funding, combined with our previous
financing event in January, provides us with the resources to
advance these programs, including the production of additional drug
product for use in the clinical trials. We are also now
well-positioned to advance the preclinical studies for our
pan-coronavirus vaccine candidate (GEO-CM02) and our MVA-VLP-MUC1
cancer immunotherapy program to further solidify our exciting
pipeline of human vaccines and immunotherapies. We look forward to
providing additional updates on our continued progress throughout
the remainder of 2022.”
Financial Review
GeoVax reported a net loss of $2,241,699 ($0.21
per share) for the three months ended June 30, 2022, compared to a
net loss of $1,314,033 ($0.18 per share) for the same period in
2021. For the six months ended June 30, 2022, the
Company’s net loss was $4,669,214 ($0.47 per share) as compared to
a net loss of $2,876,811 ($0.49 per share) in 2021.
Grant and collaboration revenues were $-0- and
$81,526 for the three-month and six-month periods of 2022,
respectively, as compared to $79,708 and $190,125 reported for the
comparable periods of 2021.
Research and development expenses were
$1,307,177 and $2,637,721 for the three-month and six-month periods
of 2022, respectively, as compared to $832,835 and $1,435,618 for
the comparable periods of 2021, with the increases primarily due to
higher personnel and consulting costs, costs of manufacturing
materials for use in clinical trials, and a generally higher level
of activity.
General and administrative expenses were
$935,311 and $2,114,335 for the three-month and six-month periods
of 2022, respectively, as compared to $733,499 and $1,805,209 for
the comparable periods of 2021, with the increases primarily
attributable to higher personnel costs (including the use of
external consultants) and patent costs.
GeoVax reported cash balances of $30.9 million
at June 30, 2022, as compared to $11.4 million at December 31,
2021. Contributing to the increase in cash balances during the
six-month period were net proceeds $18.5 million from a follow-on
offering and private placement during May and $9.2 million from a
private placement of common stock and warrants in January.
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 Wednesday, August 3, 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.
Participants are asked to pre-register for the
call via the following
link: https://dpregister.com/sreg/10169470/f3bd71e646
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 call.
The conference call will be available through a
live webcast found
here: https://event.choruscall.com/mediaframe/webcast.html?webcastid=A9WC5AAd
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 November 3, 2022. A telephonic replay
of the call can be accessed by calling 1-877-344-7529 (domestic) or
1-412-317-0088 (international) and using access code 1768209. The
telephonic replay will be available until August 17, 2022.
About GeoVax
GeoVax Labs, Inc. is a clinical-stage
biotechnology company developing human vaccines and immunotherapies
against infectious diseases and cancer using novel proprietary
platforms. GeoVax’s product pipeline includes two ongoing Phase 2
clinical trials of GEO-CM04S1 for COVID-19 as a universal booster
vaccine to mRNA vaccines authorized by the U.S. Food and Drug
Administration (FDA) and as a primary vaccine for use in
immunocompromised patients. In addition to GEO-CM04S1 for COVID-19,
GeoVax is developing GEO-CM02 as a pan-coronavirus vaccine. The
Company is also conducting a Phase 1/2 clinical trial of
Gedeptin®for treatment of head and neck cancer. Gedeptin®has been
granted orphan drug status by the FDA. Additional research and
development programs include preventive vaccines against Zika
Virus, hemorrhagic fever viruses (Ebola, Sudan, Marburg, and Lassa)
and malaria, as well as immunotherapies for multiple solid tumors.
The Company’s portfolio of wholly owned, co-owned, and in-licensed
intellectual property stands at over 70 granted or pending patent
applications spread over 20 patent families.
For additional information about GeoVax, 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 registration statement on Form S-1 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
(amounts in thousands, except per share data) |
|
|
|
|
Three Months Ended |
Six Months Ended |
|
|
|
|
June 30, |
June 30, |
|
|
|
|
2022 |
2021 |
2022 |
2021 |
Grant and collaboration revenue |
|
$- |
$80 |
$82 |
$190 |
|
|
|
|
|
|
|
|
Operating expenses: |
|
|
|
|
|
|
Research and development |
|
1,307 |
833 |
2,638 |
1,436 |
|
General and administrative |
|
935 |
733 |
2,114 |
1,805 |
|
|
|
|
2,242 |
1,566 |
4,752 |
3,241 |
Loss from operations |
|
(2,242) |
(1,486) |
(4,670) |
(3,051) |
Other income (expense), net |
|
- |
172 |
1 |
174 |
|
|
|
|
|
|
|
|
Net loss |
|
$(2,242) |
$(1,314) |
$(4,669) |
$(2,877) |
|
|
|
|
|
|
|
|
Loss per common share |
|
$(0.18) |
$(0.21) |
$(0.47) |
$(0.49) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Condensed Consolidated Balance Sheet Information |
(amounts in thousands, except common share information) |
|
|
|
|
|
|
|
|
|
|
|
June 30, 2022 |
Dec. 31, 2021 |
|
|
|
|
|
|
Assets: |
|
|
|
|
|
|
|
|
Cash and cash equivalents |
|
|
|
$30,902 |
$11,424 |
|
Other current assets |
|
|
|
1,136 |
205 |
|
Total current assets |
|
|
|
32,038 |
11,629 |
|
Property and other assets, net |
|
|
1,203 |
168 |
|
Total assets |
|
|
|
$33,241 |
$11,797 |
|
|
|
|
|
|
Liabilities and stockholders’ equity |
|
|
|
|
|
|
Total liabilities |
|
|
$5,368 |
$7,435 |
|
Stockholders' equity |
|
|
27,873 |
4,362 |
|
Total liabilities and stockholders' equity |
|
|
$33,241 |
$11,797 |
|
|
|
|
|
|
|
Common shares
outstanding |
|
|
|
16,238,739 |
6,381,541 |
|
|
|
|
|
|
|
|
|
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