Oragenics Shareholder Update
Advances Drug Development Programs Focused on Conditions with Significant Unmet Medical Needs
Oragenics, Inc. (NYSE MKT:OGEN.BC), a clinical stage biotechnology company advancing lantibiotics to treat serious bacterial
infections and biotherapeutics to treat oral mucositis (OM), today issued a shareholder update from CEO Alan Joslyn outlining the
Company’s vision and strategic growth strategy and highlights the significant accomplishments in 2016.
Dear Shareholders:
As we begin a new year, I wanted to provide an update on the Company’s strategic vision and accompanying action plan that will
fuel our future growth and drive shareholder value. With the significant accomplishments from last year and as we look ahead, we
are quickly preparing to advance our lead drug candidate, AG013, for the treatment of oral mucositis to a Phase 2 clinical trial in
addition to completing the work necessary to file an Investigational New Drug (IND) application for the lantibiotic OG716 for the
treatment of Clostridium difficile in 2017. Both programs, if successful, would yield first in class therapeutics for oral
mucositis and C. difficile, respectively. We also look forward to additional opportunities to expand our clinical
development programs through strategic collaborations and partnerships that will further strengthen our pipeline.
2016 was a transformative year for Oragenics, in which we completed several near-term objectives and continued to build a solid
foundation for long-term growth. We have established ourselves as a leading clinical-stage biotechnology company dedicated to
developing novel bio-therapeutics for serious unmet medical needs, and have spent the past year significantly advancing our
pipeline. We received Fast Track Designation for our lead candidate AG013 for oral mucositis and completed the selection process
for our second generation lantibiotic, OG716. Earlier in the year, we also successfully divested the Company’s oral probiotics
business to ProBiora Health in a favorable transaction, allowing us to focus exclusively on the development of novel
biotherapeutics and antibiotics.
AG013 for Oral Mucositis is Phase 2 Ready
Oral mucositis is one of the most debilitating side effects of chemoradiation therapy, occurring in up to 80% of patients with
head and neck cancer. Patients suffer from painful inflammation and mucosal ulceration in the lining of the oral cavity, throat and
esophagus. There are currently no commercially available treatment options addressing the underlying condition in this cancer
population.
AG013 is an ActoBiotics™ therapeutic candidate formulated as a convenient oral rinsing solution and designed by our partner
Intrexon Corporation (NYSE:XON) to deliver the therapeutic molecule Trefoil Factor 1 (TFF1) to the mucosal tissues in the oral
cavity. Trefoil Factors are a class of peptides involved in the protection of gastrointestinal tissues against mucosal damage and
play an important role in subsequent repair.
Following our Type C meeting with the U.S. Food and Drug Administration (FDA) in August 2016, they provided us with helpful
guidance on the manufacturing process for AG013 as well as matters that will help us achieve a successful Phase 2 clinical
trial.
Another key accomplishment this year was the FDA Fast Track designation we received for AG013 in November of 2016, which further
validates our science as well as highlights the serious need for a treatment for oral mucositis. This designation will allow us
more frequent interactions with the FDA and potentially shorter review times as we advance the clinical development program for
AG013.
We are well prepared for our Phase 2 trial after we successfully manufactured AG013 clinical trial material and we look forward
to the ability to submit our IND-amendment to the FDA in early 2017, and then treat our first patient shortly thereafter. The
Clinical Research Organization that will be overseeing management of the AG013 Phase 2 clinical trial has been selected and I am
pleased to note that they are already actively recruiting well-established centers in both the United States and Europe to
participate in the study.
Lantibiotic Program for Serious Bacterial Infections Preparing for IND
Clostridium difficile (C. difficile) is a bacterial infection that most commonly affects older adults in hospital
and long-term care facilities after they receive an antibiotic administration, although there is an increasing rate of infection in
younger and healthier populations. C. difficile is now associated with nearly 500,000 infections annually in the U.S.,
resulting in 29,000 deaths in the United States alone. Certain strains, including NAP-1, have seen a 400% increase in deaths since
2000. We are addressing this severe unmet medical need by developing a lantibiotic against C. difficile with our partner
Intrexon.
Through our Exclusive Channel Collaboration (ECC) with Intrexon, we have created an extensive library of potential second
generation lantibiotic homologs to MU1140, a lantibiotic peptide targeting the bacterial cell wall component called lipid II. We
know the lantibiotic class is effective in treating gram(+) infections including serious methicillin resistant Staphylococcus
aureus (MRSA) and Vancomycin Resistant Enterococci (VRE) and we intend to identify lantibiotics from our library that possess
the best physical chemical and microbiological profiles to treat serious bacterial infections.
To that end, during the summer of 2016 we completed a series of in vivo animal studies which led us to select OG716 as a
second generation MU1140 homolog for advancement into FDA IND-enabling studies for the treatment of C. difficile infections.
OG716 has distinct physical chemical advantages over predecessor compounds while also possessing enhanced intellectual property
protections. These advantages include improved stability of OG716 in gastric and small intestinal fluids thereby negating the need
for special drug formulations to selectively deliver the compound to the large intestine at the site of infection.
One of the most significant challenges to advancing lantibiotics into successful therapeutics to treat widespread serious
bacterial infections has been the inability to manufacture sufficient quantities in a cost effective manner. Through our
collaboration with Intrexon, however, we have been able to enhance yields multiple fold during our fermentation and purification
process, thereby enabling us to generate quantities sufficient to proceed with further development.
We have successfully transitioned manufacturing of OG716 to an external contract manufacturer, which has allowed us to begin the
process of manufacturing sufficient amounts of OG716 to initiate our toxicology program. The first toxicology study is underway and
after completing the additional work, we look forward to being able to file the IND for OG716 in 2017.
Key Executive Appointment
In June of 2016, I joined Oragenics as President and Chief Executive Officer and a member of the Board of Directors. I have
extensive drug development experience along with experience as a CEO at a number of private biotechnology companies and I look
forward to helping lead Oragenics to success.
Sale of Oral Probiotics Business/Financing
In June of 2016, we sold our oral probiotics business to our former Board member Christine Koski, for $1.7MM. While we were able
to monetize this business, the sale of the business has enabled Oragenics to focus solely on research and development of treatments
for unmet medical needs.
In addition to the money raised from the sale of the oral probiotic business, we raised $4.9MM in an offering in June 2016. We
plan to raise additional capital as necessary to continue advancing our product portfolio through upcoming milestones.
Looking Ahead
We are very excited about the path forward for Oragenics. We believe our new strategic focus as a clinical stage development
company for the treatment of unmet medical needs will enable the company to create a high value niche in the healthcare space while
also bringing relief to patients who currently lack sufficient treatment for their conditions.
Both our Biotherapeutics and Lantibiotics programs, if successful, would yield first in class therapeutics for oral mucositis
and C. difficile, respectively. While concentrating on the successful development of AG013 and OG716, we also look forward
to enhancing our pipeline with additional promising product candidates and partnerships where strategic interests are aligned.
Overall, we are pleased with our recent performance and anticipate the continued achievement of our goals and objectives in
2017. Most importantly, we would like to thank our loyal shareholders for their continued support.
With Best Wishes,
Alan F. Joslyn, Ph.D.
President and CEO
About Oragenics, Inc.
We are focused on becoming the world leader in novel antibiotics against infectious disease and on developing effective
treatments for oral mucositis. Oragenics, Inc. has established two exclusive worldwide channel collaborations with Intrexon
Corporation, a synthetic biology company. The collaborations allow Oragenics access to Intrexon's proprietary technologies toward
the goal of accelerating the development of much needed new antibiotics that can work against resistant strains of bacteria and the
development of biotherapeutics for oral mucositis and other diseases and conditions of the oral cavity, throat, and esophagus.
For more information about Oragenics, 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, our current need for financing to
meet our operational needs and to be able to move our product candidates forward through pre-clinical and clinical development, our
inability to obtain sufficient financing to conduct our business; any inability to obtain or delays in the Food and Drug
Administration approval for future clinical studies and testing, the future success of our studies and testing and any inability to
also achieve favorable results in human studies, our ability to successfully develop and commercialize products, the financial
resources available to us to continue research and development, any inability to regain compliance with the NYSE MKT continued
listing requirements and those other factors described in our filings with the U.S. Securities and Exchange Commission. Any
responsibility to update forward-looking statements is expressly disclaimed.
Oragenics, Inc.
Corporate:
Michael Sullivan, 813-286-7900
Chief Financial Officer
msullivan@oragenics.com
or
Investor/Media Relations:
The Ruth Group
David Burke, 646-536-7009
dburke@theruthgroup.com
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