via NewMediaWire
– GeoVax Labs, Inc. (Nasdaq:
GOVX), a biotechnology company developing immunotherapies and
vaccines against cancers and infectious diseases, today announced
financial results for the third quarter ended September 30, 2023
and provided a business update.
“We are thrilled to see material advancements
across all aspects of our business. Through the third quarter, we
are delivering on our promise to bring transformative change to the
treatment of COVID-19 by completing enrollment in our healthy
volunteer Phase 2 clinical trial evaluating GEO-CM04S1 as a
potentially more robust, more durable booster vaccine. In addition,
with two additional Phase 2 trials ongoing in immunocompromised
population, and recent publication of positive safety and potent
immunogenicity data in this population, we have strengthened our
conviction in the potential of our next-generation COVID-19 vaccine
(GEO-CM04S1) for immunocompromised patients. We believe the need
for new treatment options for immunocompromised patients in the
fight against COVID-19 is significant, particularly as we begin to
enter the winter surges of this diseases, where these patients will
be left most vulnerable,” said David Dodd, Chief Executive Officer
of GeoVax.
“We are preparing to announce initial data
readouts from two of our Phase 2 GEO-CM04S1 trials as well as
updates from our Gedeptin® clinical trial against head and neck
cancer in the coming months. Earlier this summer, we were delighted
to present clinical data which revealed the safe and feasible
administration of Gedeptin®. We believe the Gedeptin mechanism of
action to be solid tumor agnostic, and therefore offers the
potential as a therapeutic option for multiple cancer types and
positions the product for long-term growth. The third quarter of
2023 also saw new patents issued for our Ebola, Marburg, Malaria,
and HIV vaccines, demonstrating the strength of our team’s ability
to execute on our broader strategy. In addition, we advanced our
manufacturing process through the signing of a landmark
multi-product commercial license agreement with ProBioGen for the
use of their AGE1.CR.PIX®suspension cell line. We believe that
these catalysts altogether will have a profound impact on patients
in need and all our stakeholders.”
Recent Business
Achievements
GEO-CM04S1
- Enrollment completed for
Phase 2 clinical trial evaluating GEO-CM04S1 as a booster
for healthy patients who have previously received the Pfizer or
Moderna mRNA vaccine in September of 2023. An initial data readout
is expected soon.
- GEO-CM04S1 demonstrated
potent antibody and cellular immunity in immunocompromised
patients in a recent publication in the journal, Vaccines,
in August 2023. GeoVax’s Phase 2 clinical trial evaluated the
safety and immunogenicity of GEO-CM04S1, compared to either the
Pfizer/BioNTech or Moderna mRNA-based vaccine in patients who have
previously received an allogeneic hematopoietic cell transplant, an
autologous hematopoietic cell transplant or CAR-T cell therapy.
Most promising in the results published was the demonstration of
the potential of GEO-CM04S1 as a variant agnostic COVID-19 vaccine,
providing potent immunity from the Wuhan through Delta and Omicron
strains.
- In October 2023, GeoVax commenced
the planned site expansion for this trial to accelerate patient
enrollment. In addition to study enrollments completed at the City
of Hope Medical Center (Duarte, California), the trial is now open
at Wake Forest Baptist Medical Center (Winston Salem, North
Carolina), the University of Massachusetts Medical Center
(Worcester, Massachusetts), and Fred Hutchinson Cancer Center
(Seattle, Washington).
- Commenced
investigator-initiated randomized observer-blinded Phase 2 clinical
trial of COVID-19 boosters with GEO-CM04S1 or
Pfizer-BioNTech bivalent vaccines in patients with chronic
lymphocytic leukemia (CLL) in July of 2023. The trial is rapidly
enrolling patients and progressing towards an interim data
review.
- Presented data for GEO-CM02
at the Keystone Symposia Conference in an abstract titled,
MVA-vector multi-antigen COVID-19 vaccines induce protective
immunity against SARS-CoV-2 variants spanning Alpha to Omicron in
preclinical animal models in September of 2023. The data revealed
that the GEO-CM02 vaccine induced immune responses that were
efficacious against the original Wuhan strain and Omicron variants
with a single dose. This effort expands upon GeoVax’s hypothesis
that vaccines designed to induce both antibodies and T-cell
responses to multiple viral structural proteins can address the
issue of viral variation and escape from the immune system without
the need for repeated seasonal adjustments.
Gedeptin®
-
Gedeptin® clinical data
presented at the AACR-AHNS Head and Neck Cancer Conference
in an abstract titled, Phase 1/2 study of Ad/PNB with Fludarabine
for the Treatment of Head and Neck Squamous Cell Carcinoma (HNSCC)
in July 2023. The FDA-funded study revealed that the administration
of Gedeptin® is safe and feasible.
Advanced Vaccine Manufacturing Process
- GeoVax and ProBioGen
announced the signing of a landmark multi-product commercial
license agreement for ProBioGen’s groundbreaking
AGE1.CR.PIX® suspension cell line in September 2023. The agreement
enhances the manufacturing capabilities of GeoVax’s entire Modified
Vaccinia Ankara (MVA)-based vaccine portfolio with respect to both
scale and flexibility. This follows the May 2023 agreement with
Advanced Bioscience Laboratories, Inc. (ABL) to support current
Good Manufacturing Practices (cGMP) production of the Company’s
vaccine candidates. These agreements move the Company toward fully
implementing a continuous cell line manufacturing system that will
provide lower-cost, scalable versatility for our entire MVA-based
vaccine portfolio.
Intellectual Property
Developments
- GeoVax recently secured
multiple positive patent decisions covering notice of allowances
for Ebola, Marburg, Malaria and HIV vaccines.
- GeoVax announced that the U.S.
Patent and Trademark Office has issued a Notice of Allowance for
Patent Application No. 17/584,231 titled patent titled “Replication
Deficient Modified Vaccina Ankara (MVA) Expressing Marburg Virus
Glycoprotein (GP) and Matrix Protein (VP40).”
- GeoVax announced that the U.S
Patent and Trademark Office has issued a Notice of Allowance for
Patent Application No. 17/409,574 titled “Multivalent HIV Vaccine
Boost Compositions and Methods of Use.”
- GeoVax announced that the U.S.
Patent and Trademark Office has issued a Notice of Allowance for
Patent Application No. 17/726,254 titled “Compositions and Methods
for Generating an Immune Response to Treat or Prevent
Malaria.”
- GeoVax announced that the U.S.
Patent and Trademark Office has issued Patent No. 11,701,418 B2 to
GeoVax, pursuant to the Company’s patent application No. 15/543,139
titled “Replication-Deficient Modified Vaccinia Ankara (MVA) and
Matrix Protein (VP40).”
Upcoming Events
- GeoVax will participate in
upcoming conferences and industry events:
- Vaccines Summit 2023, November
13-15, 2023, Boston, MA
- World Vaccine Congress, West Coast,
November 27-30, 2023, Santa Clara, CA
- NobleCon19, December 3-5, Boca
Raton, FL
- Emerging Growth Conference,
December 6-7, Virtual
Third Quarter 2023 Financial
Results
Net Loss: Net loss for the
three months ended September 30, 2023, was $8,408,818 ($0.32 per
share) as compared to $3,968,102 ($0.17 per share) for the
comparable period in 2022. For the nine months ended September 30,
2023, the Company’s net loss was $18,374,354 ($0.69 per share) as
compared to a net loss of $8,637,316 ($0.63 per share) in 2022.
R&D Expenses: Research and
development expenses were $6,947,979 and $14,486,896 for the
three-month and nine-month periods ended September 30, 2023,
compared to $2,721,196 and $5,358,917 for the comparable periods in
2022, with the increase primarily due to the cost of conducting
clinical trials for GEO-CM04S1 and Gedeptin, costs of manufacturing
materials for use in our clinical trials, additional personnel
costs, technology license fees, costs of preclinical research
activities and a generally higher level of activity.
G&A Expenses: General and
administrative expenses were $1,651,775 and $4,562,293 for the
three-month and nine-month periods ended September 30, 2023,
compared to $1,249,337 and $3,363,672 for the comparable periods in
2022, with the increase primarily due to higher personnel costs,
investor relations consulting costs, patent costs and other
expenses supportive of a higher level of activity.
Cash Position: GeoVax reported
cash balances of $12,687,041 at September 30, 2023, as compared to
$27,612,732 at December 31, 2023.
Further information is included in the Company’s
Quarterly Report on Form 10-Q filed with the Securities and
Exchange Commission.
Conference Call Details
Management will host a conference call scheduled
to begin at 4:30 p.m. ET today, November 8, 2023, to review
financial results and provide an update on corporate developments.
A question-and-answer session will follow management’s formal
remarks.
Domestic:
+1-800-715-9871International:
+1-646-307-1963Conference ID:
7519986Webcast:
https://edge.media-server.com/mmc/p/r4i9d5j7
A webcast replay of the call will be available
for three months via the same link as the live webcast
approximately two hours after the end of the call.
About GeoVax
GeoVax Labs, Inc. is a clinical-stage
biotechnology company developing novel therapies and vaccines for
solid tumor 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 three
Phase 2 clinical trials, GEO-CM04S1 is being evaluated as a primary
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, and as a
booster vaccine in patients with chronic lymphocytic leukemia
(CLL). 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 have 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.
Company
Contact: |
|
Investor
Relations Contact: |
|
Media
Contact: |
info@geovax.com |
|
paige.kelly@sternir.com |
|
sr@roberts-communications.com |
678-384-7220 |
|
212-698-8699 |
|
202-779-0929 |
FINANCIAL TABLES FOLLOW
GEOVAX LABS, INC. |
Condensed Consolidated Statements of Operations
Information |
(amounts in thousands, except common share information) |
|
|
|
|
|
Three Months Ended |
Nine Months Ended |
|
|
|
|
September 30, |
September 30, |
|
|
|
|
|
2023 |
|
|
2022 |
|
|
2023 |
|
|
2022 |
|
Grant revenue |
|
$ |
- |
|
$ |
- |
|
$ |
- |
|
$ |
82 |
|
|
|
|
|
|
|
|
|
Operating
expenses: |
|
|
|
|
|
|
Research and
development |
|
|
6,948 |
|
|
2,721 |
|
|
14,487 |
|
|
5,359 |
|
|
General and
administrative |
|
|
1,652 |
|
|
1,249 |
|
|
4,562 |
|
|
3,364 |
|
|
|
|
|
|
8,600 |
|
|
3,970 |
|
|
19,049 |
|
|
8,723 |
|
Loss from
operations |
|
|
(8,600 |
) |
|
(3,970 |
) |
|
(19,049 |
) |
|
(8,641 |
) |
Interest income |
|
|
191 |
|
|
2 |
|
|
675 |
|
|
4 |
|
|
|
|
|
|
|
|
|
Net loss |
|
$ |
(8,409 |
) |
$ |
(3,968 |
) |
$ |
(18,374 |
) |
$ |
(8,637 |
) |
|
|
|
|
|
|
|
|
Loss per common
share |
|
$ |
(0.32 |
) |
$ |
(0.17 |
) |
$ |
(0.69 |
) |
$ |
(0.63 |
) |
Condensed Consolidated Balance Sheet
Information |
(amounts in thousands, except common share information) |
|
|
|
|
|
Sep. 30,2023 |
Dec. 31,2022 |
Assets: |
|
|
|
|
|
|
|
Cash and cash
equivalents |
|
|
|
$ |
12,687 |
$ |
27,613 |
|
Other current
assets |
|
|
|
|
2,113 |
|
1,326 |
|
Total current
assets |
|
|
|
|
14,800 |
|
28,939 |
|
Property and other
assets, net |
|
|
|
|
1,401 |
|
2,409 |
|
Total assets |
|
|
|
$ |
16,201 |
$ |
31,348 |
|
|
|
|
|
|
|
|
Liabilities and
stockholders’ equity |
|
|
|
|
|
|
Total
liabilities |
|
|
|
$ |
7,082 |
$ |
4,748 |
|
Stockholders’
equity |
|
|
|
|
9,119 |
|
26,600 |
|
Total liabilities and
stockholders’ equity |
|
$ |
16,201 |
$ |
31,348 |
|
|
|
|
|
|
|
|
Common shares
outstanding |
|
|
|
|
26,695,287 |
|
26,334,953 |
GeoVax Labs (NASDAQ:GOVXW)
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GeoVax Labs (NASDAQ:GOVXW)
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