Oragenics, Inc. (NYSE American: OGEN):
Fellow Shareholders,
As our annual meeting date approaches and in
response to valuable feedback from our shareholders, I believe it
important to highlight and summarize some of the information in our
proxy statement regarding the proposed increase in our authorized
shares as well as our cost-saving efforts.
Odyssey Asset
Purchase
On October 5, 2023, we proudly announced that
we had entered into an agreement to acquire Odyssey Health, Inc.’s
lead assets. This transaction is expected to close in December
2023, subject to various closing conditions. We view this
acquisition as a strategic move that holds significant potential
for enhancing shareholder value. The assets are related to
Odyssey’s proprietary neurological drug therapies, including their
proprietary formulation and nasal delivery system. The assets
include drug candidates for treating mild traumatic brain injury,
also known as concussion, and for treating Niemann Pick Disease
Type C. We anticipate that the alignment between these assets and
our existing nasal delivery platform could significantly expand our
reach to a broader market. We believe that our ongoing intranasal
vaccine product development, coupled with the success of this
acquisition, could positively impact both the neurological and
infectious disease markets.
Concussions represent an unmet medical need
affecting millions globally. In the U.S. alone, an estimated 5
million concussions occur annually, with up to 50% going
unreported. The global market for concussion treatment was valued
at $6.9 billion in 2020, with a forecasted growth to $8.9 billion
by 2027, according to Grandview Research.
Niemann Pick Type C Disease is a rare
neurodegenerative genetic disorder with a growing market, projected
to increase from $128 million in 2022 to $188 million in 2031
across the U.S., Germany, and the U.K.
The potential acquisition of the Odyssey
assets also introduces a team of talented scientists who could
greatly enhance our current research and development efforts at
Oragenics, particularly in the fields of infectious and
neurological drug therapies and intranasal drug delivery
systems.
Proposal 3 of our
2022 Annual Meeting
We've received numerous requests for further
clarification regarding Proposal 3 within the seven items on our
annual meeting agenda. Currently, Oragenics has an aggregate of
54,166,666 shares of authorized capital stock, comprised of
4,166,666 shares of common stock with a par value of $0.001 and
50,000,000 shares of preferred stock with no par value.
Out of the 4,166,666 authorized common
shares, approximately 2.5 million have been issued, with around
383,000 reserved for stock options and warrants. The remaining 1.2
million shares are available for issuance or capital-raising
efforts.
The closing of the Odyssey acquisition is
conditioned, among other things, on the increase of our authorized
common stock. If Odyssey were to convert all the Series F
Convertible Preferred Stock we will issue to Odyssey, assuming the
successful closing of the acquisition, we would be required to
issue 8 million shares of common stock, which we cannot do without
increasing our authorized common stock.
Furthermore, as discussed in our most recent
Form 10-Q filed with the SEC on August 11, 2023, we have a need for
additional capital to support ongoing research and development.
While we explore various funding avenues, including non-dilutive
and dilutive opportunities, increasing the authorized shares of
common stock is essential for substantial capital infusion through
equity sales.
We understand concerns about potential
dilution and its impact on shareholders. It is crucial to note that
increasing authorized shares enables us to act quickly as financing
opportunities may arise. As of this letter's date, there are no
immediate plans or agreements to issue the additional shares of
Common Stock proposed, except those related to the Odyssey asset
purchase. Our goal is to position the company for success,
facilitating the Odyssey asset purchase and future financing
needs.
Ongoing Partnerships
and Progress
Regarding our current contracts and
partnerships with Inspirevax and CQDM, we remain dedicated to these
strategic alliances and the development of a successful nasal
delivery system for our vaccine candidate. Biotech research and
development is an ongoing process requiring time, dedication, and
financial commitment.
In recent months, we've made tough yet
necessary decisions to reduce expenses and conserve cash resources
to prioritize our vaccine product's research and development. We
maintain our optimism for the future of our vaccine candidate while
working to secure the required additional capital for our continued
progress. We believe in the potential of intranasal drug therapies
and devices, and we will provide substantial updates as they
unfold.
Thank you for your continued support of
Oragenics. I encourage you to vote at the annual meeting and
support our mission to impact even more lives and improve human
health in meaningful ways. Proxy materials can be found on the
internet at www.cstproxy.com/oragenics/2023 or at the SEC website
at www.sec.gov.
Kimberly Murphy Chief Executive Officer and
President November 2, 2023
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 including without
limitation statements regarding the ability of the Company to
successfully close the Odyssey acquisition, the ability of the
Company to timely and successfully achieve the anticipated benefits
of acquiring the Odyssey assets and the Company’s future
performance, business prospects, events and product development
plans. 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 increase its authorized shares of Common Stock;
the Company’s ability to obtain a quorum at future shareholders
meetings; the Company’s ability to satisfy the closing conditions
to the Odyssey acquisition; the Company’s ability to advance the
development of its product candidates 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
its 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 the
outcome of preclinical studies, nasal administration, transmission,
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 communication is as of the date hereof. You should
consider these factors in evaluating the forward-looking statements
included in this communication 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.
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version on businesswire.com: https://www.businesswire.com/news/home/20231102680513/en/
Oragenics, Inc. Janet Huffman, Chief Financial Officer
813-286-7900 jhuffman@oragenics.com
LHA Investor Relations Tirth T. Patel 212-201-6614
tpatel@lhai.com
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