Oragenics Provides an Update on Funding for its SARS-CoV-2 Vaccine
September 28 2020 - 07:30AM
Business Wire
Oragenics, Inc. (NYSE American: OGEN) (“Oragenics” or the
“Company”) provides an update on U.S. federal government and other
funding options the Company is pursuing in order to advance its
SARS-CoV-2 vaccine, Terra CoV-2.
Oragenics has been informed by the Biomedical Advanced Research
and Development Authority (“BARDA”) of BARDA’s determination not to
enter into negotiation with the Company. While BARDA noted the
Company’s submission aligned with its mission, a combination of
factors, including availability of funds, precluded the agency from
entering into negotiations at this time.
“We remain committed to our Terra CoV-2 vaccine candidate and
expect to continue development through to the completion of a Phase
1 clinical trial,” said Alan Joslyn, Ph.D., President and Chief
Executive Officer. “We have completed analytical method feasibility
and qualification activities with our contract manufacturer and
have advanced in creation of our research cell bank. Although we
are disappointed with BARDA’s funding decision, we will continue to
pursue other sources of non-dilutive funding of grants and
corporate partnerships, and possibly equity capital to advance
development of our promising vaccine.
BARDA noted that evaluation of vaccine development under the
Operation Warp Speed (“OWS”) program continues and can be an avenue
for promising vaccine candidates, which the Company believes Terra
CoV-2 to be. In addition, BARDA has suggested that if promising
vaccine candidates are identified, there is also an opportunity for
a potential partnership with the Joint Program Executive Office for
Chemical, Biological, Radiological and Nuclear Defense
(JPEO-CBRND). BARDA is part of the U.S. Department of Health and
Human Services, OWS is a public-private partnership initiated by
the White House in May 2020 and JPEO-CBRND is part of the U.S.
Department of Defense.
“Our focus is on the stabilized prefusion spike protein that may
confer lifetime immunity to COVID-19 along with other significant
points of differentiation including storage and distribution at
refrigerated temperatures versus other vaccines currently in
development. We will be holding a pre-IND meeting with the FDA in
the near future that we expect will help clarify the requirements
to advance our program into the clinic. We believe that additional
government funds could be made available during the federal
government’s new fiscal year, which begins on October 1, that we
can pursue for development of Terra CoV-2,” Dr. Joslyn added.
About Terra CoV-2
In March 2020, Oragenics acquired a non-exclusive license from
the National Institutes of Health (“NIH”) for its stabilized
prefusion Terra CoV-2 spike protein. Oragenics recently announced
that its spike protein had been successfully inserted into Chinese
Hamster Ovary (“CHO”) cells and “mini-pool” production and
analytical development are underway. CHO cells are used to produce
a number of FDA-approved recombinant proteins.
About Oragenics, Inc.
Oragenics, Inc. is focused on the creation of the Terra CoV-2
vaccine candidate to combat the novel coronavirus pandemic and the
further development of effective treatments for novel antibiotics
against infectious disease. The Company is dedicated to the
development and commercialization of a vaccine candidate providing
specific immunity from novel coronavirus. The Terra CoV-2
immunization leverages coronavirus spike protein research conducted
by the National Institute of Health. In addition, Oragenics has an
exclusive worldwide channel collaboration with ILH Holdings, Inc.
(n/k/a Eleszto Genetika, Inc.), relating to the development of
novel lantibiotics.
For more information about Oragenics, please visit
www.oragenics.com.
Safe Harbor Statement
Under the Private Securities Litigation Reform Act of 1995: This
release includes forward-looking statements that reflect
management’s current views with respect to future events and
performance. 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
TerraCoV-2 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 Noachis Terra’s TerraCoV-2
vaccine, 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 TerraCoV-2, including any meetings, decisions by
regulatory authorities, such as the FDA and investigational review
boards, whether favorable or unfavorable; 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; 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 risks, as well as other
uncertainties described in our filings with the U.S. Securities and
Exchange Commission. Oragenics assumes no responsibility to update
any forward-looking statements contained in this press release or
with respect to the matters described herein.
View source
version on businesswire.com: https://www.businesswire.com/news/home/20200928005238/en/
Oragenics: Michael Sullivan Chief Financial Officer
813-286-7900 msullivan@oragenics.com Investors: John Marco
Managing Director CORE IR 516-222-2560 johnm@coreir.com
Media: Jules Abraham CORE IR 917-885-7378
julesa@coreir.com
Oragenics (AMEX:OGEN)
Historical Stock Chart
From Feb 2024 to Mar 2024
Oragenics (AMEX:OGEN)
Historical Stock Chart
From Mar 2023 to Mar 2024