Oragenics, Inc. (NYSE American: OGEN) (“Oragenics” or the
“Company”) today issued the following letter to shareholders
from its Executive Chairman, Frederick W. Telling, Ph.D.:
To My Fellow Shareholders,
I am pleased to share with you an update on Oragenics’ vaccine
development strategy, as well as to discuss how our intranasal
SARS-CoV-2 vaccine candidate holds potential to play an important
role in addressing the pandemic and endemic phases of COVID-19 and
how it shapes our long-term corporate goals. I thank you for your
continued support of Oragenics and our vision, and am delighted to
report on our recent progress.
In previous letters I affirmed the strategic direction Oragenics
is taking and discussed our commitment to the speedy yet prudent
execution of our development work. I also explained how securing
additional complementary partner agreements fundamentally
differentiates our program by providing the technology to improve
the strength, versatility and manufacturing efficiency of our
intranasal COVID-19 vaccine candidate, NT-CoV2-1. Through this
letter I aim to provide clarity on the opportunity, rationale and
pathway toward human clinical testing.
We believe that given the scope of the pandemic along with
additional vaccines projected to become available, there will be
considerable demand for our highly differentiated NT-CoV2-1 vaccine
once development is successfully completed. We intend to combine
the research, intellectual property protection and biological
materials covered by our NIAID license with our existing clinical
research and manufacturing capabilities to respond to this ongoing,
global public health crisis. With our research collaborations and
recent extensions that enable us to pursue future variants, we
believe our NT-CoV2-1 vaccine holds the promise of playing an
important role in addressing this crisis.
NT-CoV2-1, a Novel Approach to Vaccine Development
Oragenics’ NT-CoV2-1 program leverages coronavirus spike protein
research licensed from the National Institutes of Health (NIH) and
a Chinese Hamster Ovary (CHO) cell line expression system licensed
from the National Research Council of Canada (NRC). We believe it
provides an agile production platform that supports faster
development of spike protein antigens, or immune system response
stimulants, to address new SARS-CoV-2 variants as they emerge.
Importantly, our recently extended platform could allow for the
production of cell lines within six to eight weeks of spike gene
sequence availability, compared with six to nine months for
traditional production of such cell lines, thereby expediting
evaluation of future intranasal vaccine candidates in preclinical
and clinical studies. The spike protein is formulated with a
proteosome-based mucosal adjuvant (BDX301) to enable intranasal
immunization.
Market Positioning
The overall disease burden from COVID-19 has continued to
increase in the U.S. despite 91% of those age 65 or older being
fully vaccinated and 71% of those age 5 or older. Current vaccines
have reduced the rates of hospitalization and death due to COVID-19
in vaccinated individuals, but the transmission levels even in
vaccinated individuals has allowed SARS-CoV-2 variants to continue
to circulate. We believe an intranasally-administered vaccine
against COVID-19 has the potential to reduce transmission more
effectively than those delivered intramuscularly because the
intranasal route is expected to induce mucosal immunity in the nose
and throat, which are the early entry points for the SARS-CoV-2
virus.
Our primary focus remains on developing our intranasal
administered vaccine, NT-CoV2-1, as a single-dose booster since the
market opportunity for COVID-19 vaccines will likely evolve as more
of the global population receives their primary vaccine doses this
year and next.
Among other factors, the market for booster doses will be driven
by the need for updated vaccines to provide protection against
future virus variants, as well as vaccines for unvaccinated infants
and children. Oragenics is positioning NT-CoV2-1 to compete in this
later phase of the COVID-19 pandemic.
Preclinical Development Overview & Next Steps
We began preclinical studies in June 2021 through our
collaboration and material transfer agreement with the NRC. We
initiated an immunogenicity study in mice to evaluate several
adjuvant candidates. Last August, we announced the successful
completion of these mouse immunogenicity studies, which support
further development using either the intramuscular or the
intranasal route of administration. We initiated a hamster
challenge study in September 2021 to assess inhibition of viral
replication using adjuvants specific for intramuscular and
intranasal administration.
In December of 2021, we announced that the vaccines delivered by
intranasal and intramuscular routes in hamsters, both generated
robust immune responses and reduced SARS-CoV-2 viral loads to
undetectable levels in the nasal passages and lungs five days
following a viral challenge. By contrast, hamsters in the control
groups that had received saline or adjuvants alone had no
detectable immune response along with substantial viral loads.
GLP Toxicology Study
In March of 2022, following a positive assessment of a
rabbit-based pilot study, we initiated a Good Laboratory Practice
(GLP) toxicology study to evaluate the safety profile and
immunogenicity of NT-CoV2-1 in rabbits. This important preclinical
study is designed to provide data required to advance our
intranasal vaccine candidate into human clinical studies. Although
the study remains underway, based on our previous preclinical
results we are encouraged that this study may further support our
intranasal development path.
Regulatory Strategy
The completion of the rabbit toxicology study is the final
element of our preclinical development work, prior to initiating a
Phase 1 clinical study in North America with NT-CoV2-1, the
protocol for which is currently under development.
In parallel with our pursuit of an IND for a US-based Phase 1
study, Oragenics is exploring regulatory approval for an equivalent
safety and immunogenicity study with Health Canada through the
submission of a Clinical Trial Application (CTA). Given Health
Canada’s experience with related adjuvants to that used in
NT-CoV2-1 and the growing urgency for nasal vaccine solutions, we
believe this alternate regulatory path remains a viable route for
maintaining our development timelines.
Benefits of Intranasal Vaccine Delivery
As discussed, we remain focused on our intranasal candidate,
NT-CoV2-1, as we see its innate benefits as key points of
differentiation in combatting the COVID-19 pandemic and increasing
access to vaccines globally. Our vaccine candidate has many
potential competitive features and benefits, including:
- Targeting Mucosal Immunity – Conventional injectable
vaccines are poor inducers of mucosal immunity, whereas intranasal
immunization can induce strong mucosal immunity by enhancing the
immune response at the entry sites of mucosal pathogens. When the
SARS-CoV-2 virus enters the nasal cavity, the respiratory
epithelial layer is the first barrier against viral infection. The
intranasal route of vaccination provides two additional layers of
protection over intramuscular shots because (i) it produces
immunoglobulin A and resident memory B and T cells in the
respiratory mucosa that are an effective barrier to infection at
those sites, and (ii) cross-reactive resident memory B and T cells
can respond earlier than other immune cells should a viral variant
start an infection.
- Needle-Free Administration – As an obvious benefit,
intranasal administration means needle-free delivery, resulting in
meaningful differentiation for children and needle-phobic
populations, improved compliance and the potential for
self-administration.
- Storage & Transport – The currently available
mRNA-based vaccines have been delivered globally via stringent
storage and transport requirements that strain distribution
logistics under the best of circumstances. A key benefit of our
NT-CoV2-1 candidate is a significantly reduced handling burden,
allowing transport at a more manageable refrigeration temperature
(5°C) that improves access globally including remote and
under-vaccinated geographies.
- Durability – Broad initial success with mRNA vaccines
has significantly diminished COVID-19’s impact and death, but the
trade-off has been fleeting efficacy. By benefitting from the
immunological properties of the hybrid NIH/NRC construct, NT-CoV2-1
is potentially much more durable and long-lasting than currently
available mRNA-based therapies.
Our Balance Sheet
We expect to use current cash resources to advance the
development of NT-CoV2-1 through IND-enabling studies, including
immunogenicity, viral challenge studies, toxicology studies and the
Phase 1 trial. Subsequent clinical development will be contingent
upon the receipt of additional funding, including non-dilutive
government grant funding we continue to pursue, or securing a
partnering or licensing transaction.
2020 Annual Meeting
As a final topic, I would like to thank the shareholders who
voted at our reconvened 2020 Annual Meeting, which was ultimately
successfully held in February 2022. We are pleased that a majority
of shareholders signaled support for amendments including (i) an
increase of 50,000,000 authorized shares of common stock going from
200,000,000 to 250,000,000 shares, and (ii) a reduced quorum
requirement from a majority of shares entitled to vote to one-third
of shares entitled to vote in order to constitute a meeting of
shareholders. The latter amendment significantly reduces the
likelihood of having to reconvene an annual meeting simply because
a quorum could not be met, as we experienced this past year.
Looking Ahead
In closing, I am very excited about the future of Oragenics to
become a leader in intranasal vaccine technology and am optimistic
about our candidate’s market positioning. On behalf of the
Oragenics Board of Directors, I thank you for your continued
support and look forward to keeping you apprised of our ongoing
progress.
Sincerely,
Frederick W. Telling Executive Chairman
May 17, 2022
About Oragenics, Inc.
Oragenics, Inc. is a development-stage company dedicated to
fighting infectious diseases including coronaviruses and
multidrug-resistant organisms. Its lead product is NT-CoV2-1, an
intranasal vaccine candidate to prevent COVID-19 and variants of
the SARS-CoV-2 virus. The NT-CoV2-1 program leverages coronavirus
spike protein research licensed from the NIH and the NRC with a
focus on reducing viral transmission and offering a more
patient-friendly intranasal administration. Its lantibiotics
program features a novel class of antibiotics against bacteria that
have developed resistance to commercial antibiotics. For more
information about Oragenics, please visit www.oragenics.com.
Forward-Looking Statements
This communication contains “forward-looking statements” within
the meaning of the safe harbor provisions of the U.S. Private
Securities Litigation Reform Act of 1995. These forward-looking
statements are based on management’s beliefs and assumptions and
information currently available. The words "believe," "expect,"
"anticipate," "intend," "estimate," "project" and similar
expressions that do not relate solely to historical matters
identify forward-looking statements. Investors should be cautious
in relying on forward-looking statements because they are subject
to a variety of risks, uncertainties, and other factors that could
cause actual results to differ materially from those expressed in
any such forward-looking statements. These factors include, but are
not limited to, the following: the Company’s ability to advance the
development of its vaccine candidate and lantibiotics candidate
under the timelines and in accord with the milestones it projects;
the Company’s ability to obtain funding, non-dilutive or otherwise,
for the development of the vaccine and lantibiotic product
candidates, whether through its own cash on hand, or another
alternative source; the regulatory application process, research
and development stages, and future clinical data and analysis
relating to vaccines and lantibiotics, including any meetings,
decisions by regulatory authorities, such as the FDA and
investigational review boards, whether favorable or unfavorable;
the potential application of our vaccine candidate to variants and
other coronaviruses; the Company’s ability to obtain, maintain and
enforce necessary patent and other intellectual property
protection; the nature of competition and development relating to
COVID-19 immunization and therapeutic treatments and demand for
vaccines and antibiotics; the Company’s expectations as to
administration, manufacturing, storage and distribution; other
potential adverse impacts due to the global COVID-19 pandemic, such
as delays in regulatory review, interruptions to manufacturers and
supply chains, adverse impacts on healthcare systems and disruption
of the global economy; and general economic and market conditions
and risks, as well as other uncertainties described in our filings
with the U.S. Securities and Exchange Commission. All information
set forth in this press release is as of the date hereof. You
should consider these factors in evaluating the forward-looking
statements included in this press release and not place undue
reliance on such statements. We do not assume any obligation to
publicly provide revisions or updates to any forward-looking
statements, whether as a result of new information, future
developments or otherwise, should circumstances change, except as
otherwise required by law.
View source
version on businesswire.com: https://www.businesswire.com/news/home/20220517005205/en/
Oragenics, Inc. Michael Sullivan, Chief Financial Officer
813-286-7900 msullivan@oragenics.com
LHA Investor Relations Tirth T. Patel 212-201-6614
tpatel@lhai.com
Oragenics (AMEX:OGEN)
Historical Stock Chart
From Aug 2024 to Sep 2024
Oragenics (AMEX:OGEN)
Historical Stock Chart
From Sep 2023 to Sep 2024