Full Press Release Details
Issues Letter to Shareholders
Chairman Affirms Company Direction with Commitment to Speedy Execution of Business Strategy
Deep Bench Strength Among Management, Board and Advisors in Vaccine Development and in Life Sciences
(May 18, 2021) - Oragenics, Inc. (NYSE American: OGEN) today issued the following letter to shareholders from its Executive
Chairman, Frederick W. Telling, PhD:
My Fellow Shareholders,
light of the recent changes to the executive management team of Oragenics, I would like to affirm to our shareholders the overall
direction of our company is unchanged and to express my deep commitment to a speedy yet prudent execution of our business strategy.
Following the resignation of Alan Joslyn, PhD as Chief Executive Officer I have taken on a more active role in the day-to-day
management of Oragenics under my new title of Executive Chairman.
behalf of the Oragenics Board of Directors and my colleagues, I thank Dr. Joslyn for his service and dedication. He helped put
in place several initiatives that management and outside advisors are now advancing in a meaningful way. In particular, we are
working quickly to develop the Terra CoV-2 vaccine candidate to address SARS-CoV-2 and its variants, as well as a new class of
lantibiotics to address the daunting problem of antibiotic resistance. Rest assured we are committed to the speedy execution of
milestones and have the human capital to get it done.
me share with you some more detail about our human capital, meaning the talented professionals who are working on behalf of our
shareholders and the patients afflicted by infectious diseases around the world. Personally, I was honored to work for Pfizer
for 30 years until retiring in June 2007. I was appointed as Corporate Vice President and Vice President of Corporate Strategic
Planning and Policy in October of 1994. During my career, my focus was on product licensing, mergers and acquisitions, and global
health policy. I joined the Oragenics Board of Directors in 2011, so I have been intimately involved with our programs and developments
for a number of years. This tenure has given me insight into the capabilities of our team and the potential of our pipeline. I
hold a PhD in Economics and Public Policy from Cornell University.
to the occasion is Michael Sullivan, who has served as Chief Financial Officer of Oragenics since 2012. He has now assumed the
additional title of Interim Principal Executive Officer. Michael's public and private company experience is extensive, having
served as Chief Financial Officer for several companies in Florida over the course of his career. He holds the CPA designation
and an MBA from Florida State University College of Business.
(Marty) Handfield, PhD is a talented scientist leading the research and development activities at Oragenics. Serving as our Senior
Vice President, Discovery Research, Dr. Handfield joined our company in 2009. Prior to Oragenics, he was a Tenured Associate Professor
at the Center for Molecular Microbiology and the Department of Oral Biology at the University of Florida College of Dentistry,
where he co-invented IVIAT and co-founded ivi Gene Corp. and Epicure Corp. to commercialize this and related technologies. He
received his MS and PhD in Microbiology and Immunology from the Universit Laval College of Medicine.
want to highlight some of my Director colleagues with particularly notable experience in vaccine and drug development. We are
fortunate to count among them Kimberly M. Murphy, who joined the Board in May 2020 when we acquired Noachis Terra. She is an accomplished
leader and proven professional with substantial experience in vaccine development, including more than a decade at GlaxoSmithKline
(GSK). At GSK she led the global influenza vaccine and pandemic preparedness businesses and was responsible for the strategic
and prelaunch planning for multiple development-stage vaccines through to commercialization, including Shingrix. She managed a
2,000-person vaccine development, sales, manufacturing and distribution team, and was responsible for the integration planning
of GSK's acquisition of Novartis AG's vaccine division. Earlier in her career, she worked in commercialization and
marketing roles within Novartis Vaccines and Diagnostics Inc. and Merck & Co., Inc. Kim holds an MBA in Pharmaceutical Marketing
from Saint Joseph's University.
W. Dunton, MD is a long-serving Director, having joined our Board in 2011. Alan is the principal and founder of Danerius, LLC,
which since 2006 has provided specialized consulting services to public and private pharmaceutical and biotechnology companies.
While his more recent affiliations have been with smaller public biotechnology companies, and he currently serves on the boards
of directors of Palatin, Inc., CorMedix and Recce, Ltd., he has extensive large pharmaceutical experience as well. From 1994 to
2001, Dr. Dunton was a senior executive in various capacities in the Pharmaceuticals Group of Johnson & Johnson, and also
held leadership roles at the Janssen Research Foundation, a Johnson & Johnson Company. Dr. Dunton holds an MD degree from
New York University School of Medicine.
from Esteemed Advisors
these executives and Directors bring to Oragenics tremendous pharmaceutical and vaccine experience, we also have engaged various
advisors to help us navigate the research and development, manufacturing and regulatory pathways.
engaged David Zarley, PhD, who has more than 30 years in vaccine research and development in the private sector, including as
a consultant to Noachis Terra. He was Vice President of Program Management for Vaccine Research and Development at Pfizer and
Senior Director / Medicines Team Leader for Pfizer Primary Care Business Unit. He was also a Senior Director for Wyeth Research
Project Management Business Unit and Senior Director for Technical Operations and Product Supply at Wyeth Vaccines. His experience
includes Senior Research Biochemist and Project Leader for Viral Vaccine Research and Development at Lederle-Praxis Biologicals.
Dr. Zarley received his PhD in Molecular, Cellular and Development - Biology from Indiana University.
(Terry) Cochrane is President at BrevisRefero Corporation in Ontario, Canada, and brings to Oragenics two decades of life sciences
industry experience with 20+ years of progressive management experience in biopharmaceutical development and GMP manufacturing
industry for biologics therapies and vaccines. BrevisRefero provides biopharma outsourcing assistance in the identifying and selecting
service providers and follow-on technical program management to realize delivery of products to clinic and market. It supports
complex clinical-stage programs by handling technology transfer, development, scale-up and GMP manufacturing along with CMC regulatory
strategy and support Terry holds a BSc degree from the University of Winnipeg in Biochemistry and Biology.
have also engaged a third independent advisor with more than 30 years of vaccine development experience in early- to late-stage
research and development programs, including technology transfer of projects along the continuum from academic labs to industry
research labs, to development labs and on to manufacturing and quality control settings. This advisor spent nearly 20 years at
Merck, helping to develop several blockbuster vaccines, and has been a vaccine development consultant to MNCs, small biotechs
and NGOs around the world for more than 10 years.
am proud to call all of these talented individuals my colleagues, and collectively our skills and experiences are tremendous.
The key takeaway for you, our shareholders, is that Oragenics' scientific expertise is exceptional and broad. These individuals
will be redoubling their efforts to bring a solution to the most pressing needs of the planet as quickly as possible.
Terra CoV-2 COVID-19 vaccine program is investigating two different modes of administration, namely intramuscular and intranasal.
Animal work is ongoing, as are discussions with potential partners. That said, we are committed to accelerating the advancement
of this program. As a reminder, the Terra CoV-2 vaccine is based on a nonexclusive intellectual property license from the National
Institutes of Health (NIH) to the prefusion stabilized spike protein vaccine candidate. Our license covers stabilizing the spike
protein in the pre-fusion state, which may permit the number of immunogenic centers to be increased. This could allow for a greater
likelihood of successful antibody generation, resulting in improved immunogenic responses.
released information indicates that pretreatment of mice with the NIH-created COVID-19 spike protein in combination with an adjuvant
(TLR-4 agonist Sigma Adjuvant System) completely inhibited viral growth in the nasal cavities and lungs of infected animals, compared
with unvaccinated control animals. In October 2020, we received feedback to our Type B Pre-IND Meeting Request from the FDA. The
response indicated that the FDA broadly supported our planned approach to the preclinical program that will ultimately support
our clinical development of the Terra CoV-2 vaccine. As a result, we anticipate filing the IND application in the fourth quarter
of 2021 and immediately upon the receipt of approval from the FDA, commencing the Phase 1 clinical study, the protocol for which
is currently under development.
March 2021, we entered into a material transfer agreement with Biodextris Inc. for the use of three intranasal mucosal adjuvants
in our Terra CoV-2 vaccine against COVID-19. The three adjuvants - BDX100, BDX300 and BDX301 - are proteosome-based
adjuvants comprised of proteins and lipopolysaccharides with improved attributes including enhanced immune response, manufacturing
efficiency and the benefits of intranasal vaccine administration. As a reminder, this initial agreement calls for the three intranasal
adjuvants to be used in combination with our antigen vaccine candidate as part of the preclinical immunological evaluation of
Terra CoV-2, for the prevention of coronavirus disease caused by infection with SARS-CoV-2 virus.
next steps will be to study Terra CoV-2 plus Biodextris' intranasal mucosal adjuvants in preclinical animal studies, including
hamster viral challenge studies, mouse immunogenicity studies and the rodent toxicology study. The information generated from
the studies employing the new intranasal vaccine candidate may support our IND application and an application to Health Canada
to initiate clinical trials. Importantly, our advisors have deep knowledge of research approaches that we may use to speed up
President Biden's stated goal is to vaccinate 70% of the U.S. population with at least one dose of the currently emergency
use authorized vaccines by July 4th, and COVID-19 cases are dropping in the U.S., the pandemic continues to rage unabated
elsewhere in the world, most notably in India. We believe our Terra CoV-2 vaccine will play an important role not only in addressing
the current COVID-19 pandemic, but also in addressing new variants of concern and other coronaviruses that may come our way.
Lantibiotics Program
is more than a COVID-19 vaccine company. Our foundation is lantibiotics, and we continue our preclinical work with this novel
class of antibiotics to address multidrug-resistant organisms. While the world is currently focused on eradicating COVID-19, it