ONI BioPharma Inc. Offers Investor Update. Topics Include: (1) Appeal of American Stock Exchange Delisting Decision, (2) Operat
October 31 2008 - 4:36PM
Marketwired
Oragenics, Inc. d/b/a ONI BioPharma Inc. (AMEX: ONI) announced,
that it received a letter from the NYSE Alternext US LLC* (formerly
known as the American Stock Exchange, hereinafter the "Exchange" or
"ASE"), on October 27, 2008 confirming the Exchange's intention to
proceed with the filing of an application with the Securities and
Exchange Commission ("SEC") to delist the common stock of the
Company from the Exchange. The notice from the Exchange indicates
that the ASE staff has decided that the Company does not meet the
following continued listing standards under the ASE Company Guide:
Section 1003(a)(ii) in that the Company's stockholders' equity is
less than $4 million and it has sustained losses in three of its
four most recent fiscal years. On October 31, 2008, the Company
filed a request to appeal the Exchange's determination and
requested a hearing before a panel of the Exchange. As of the date
hereof, no date has been set for such hearing, but the hearing is
expected to be held within 45 days. During this period, the
Company's common stock will continue to be listed on the Exchange
pending the outcome of the appeal. The Company plans to vigorously
appeal and if the Company's position is accepted by the panel, this
would allow the Company to continue its listing. However, there can
be no assurance that the Company's request for continued listing
will ultimately be granted. Also, while the Company is considering
alternatives for repositioning itself on other exchanges, including
ongoing discussions with potential listing sponsors and market
makers, the Company expects that its shares will be listed on
another exchange or quoted on a quotation medium prior to any
termination in trading on the ASE. Should the Company's appeal be
denied, management does believe that following the effectiveness of
the Company's delisting, trading in the Company's common stock
would be conducted on the OTC Bulletin Board in the United States.
In light of the Company's establishment of an affiliate in
Mexico and its internationalization initiatives in Latin America
and Europe, the Company has also been actively pursuing a listing
on an exchange or exchanges, including in Europe and North America,
that could offer broader exposure to international investors and
markets and a better fit for the Company given its sector
profile.
ONI has made great strides operationally in the past several
months, including, the following significant events:
-- Successful Synthesis of Lantibiotic using DPOLT(TM). We announced the
successful synthesis of an antibiotic using its proprietary DPOLT(TM)
technology. The molecule belongs to a class of antibiotics called
Lantibiotics that were first discovered over 80 years ago. Although there
are now over 50 different Lantibiotics known, this is the first report of a
cost-effective method for making one in sufficient amounts and with
sufficient purity to enable comprehensive testing and commercial viability.
As a first step in further development, the Company has retained Almac
Sciences, a leading contract manufacturer and a division of the Almac
Group, to refine and scale-up GMP production of the synthetic MU1140(TM)
analogue to achieve sufficient quantities for it to be fully tested for
regulatory approval. It is estimated that the regulatory process will take
three years before this drug could become available. Other synthetic
Lantibiotics will follow as they are developed and tested.
-- Marketing of ProBiora3(TM) and EvoraPlus(TM). We announced the
launch of our marketing program for ProBiora3, our oral probiotic
technology, which will initially include the introduction of EvoraPlus(TM)
into the marketplace. EvoraPlus(TM) is the first of several products to be
launched under the Evora(TM) brand, which is our house brand. We
anticipate the next Evora product that we will launch will be EvoraPet(TM).
In our estimation, the initial response to ProBiora3(TM) and EvoraPlus(TM)
has been exceptional. We have had several meetings with some of the
largest retailers in the US who have expressed a strong interest in our
products. We have received orders for both ProBiora3(TM) and EvoraPlus(TM)
and expect to begin shipping in the fourth quarter of this year. For
further information, please visit www.probiora3.com and www.evoraplus.com.
-- Diagnostics. We recently entered into a Collaboration Agreement with
a major, global diagnostics company regarding our gene targets for various
stages of colorectal cancer that we discovered using the PCMAT(TM)
platform. We have also initiated a new internal program for both the
PIVIAT(TM) and PCMAT(TM) platforms. Under this initiative whereby we will
augment our development work by including the validation of gene targets we
have discovered through the use of the platforms. We anticipate that this
will in turn make our gene targets more valuable and decrease time to
market for any test that utilizes them.
-- Formation of Mexican Subsidiary. We initiated the formation of a
Mexican Subsidiary. We anticipate that this Subsidiary will provide us
with several advantages including reduced cost for clinical trials and
access to the Latin American markets. We will begin marketing
EvoraPlus(TM) in Mexico as soon as regulatory approval is achieved. We
will also initiate further clinical trials for our SMaRT(TM) Replacement
Therapy technology which provides a one-time application for life-time
prevention of dental caries (tooth decay). We have also begun the process
of forming a collaboration with the Instituto de Biolotecnolog�a,
Universidad Nacional Aut�noma de M�xico ("IBUNAM"), the premier
biotechnology institute in Mexico generally recognized as having the best
and brightest scientists in Mexico. We expect to work with IBUNAM on
several projects including projects to discover novel gene targets using
our PIVIAT(TM) and PCMAT(TM) platforms.
Stanley Stein, President and Chief Executive Officer, commented,
"We are very pleased with the Company's progress in achieving its
operational goals, and we believe that ONI is now better positioned
than it ever has been. We do not believe that the letter from the
ASE will preclude the achievement of any of our operational
objectives as we endeavor to reposition the Company to attract more
investors who are familiar with science and technology. While we
intend to appeal the ASE decision with full vigor, we have also
been actively pursuing the listing or quotation of our shares on
other exchanges, including in Europe and North America, and we
expect to make an additional announcement in connection with our
plans prior to the effective date, if any, of a delisting from the
ASE. It is our goal to provide every current and potential
shareholder with access to a trading market and an accurate quote
at times convenient to each investor. "
ONI will be scheduling an investor call at a date and time to be
announced after the release of the third quarter 10-Q, to provide
investors with a detailed operational update.
*The American Stock Exchange was acquired by NYSE Euronext on
October 1, 2008, and its name was changed to NYSE Alternext US
LLC.
About ONI BioPharma Inc.
Oragenics, Inc. (d/b/a ONI BioPharma Inc.) is a
biopharmaceutical company with a pipeline of unique proprietary
technologies, some of which are being commercialized. The Company
also has a number of products in discovery, preclinical and
clinical development, with a concentration in the main therapeutic
area of infectious diseases, diagnostics, and oral health. The
Company has developed platform technologies with respect to its
products, thereby creating a pipeline of future products, which the
Company expects to develop.
Safe Harbor Statement: Under the Private Securities Litigation
Reform Act of 1995: This release includes forward-looking
statements that reflect ONI BioPharma's current views with respect
to future events and financial 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, our
ability to qualify to be listed on another exchange if we are
delisted or to otherwise be quoted on a quotation medium, future
costs associated with any potential listing sponsor or changing to
another exchange, those factors set forth in our most recently
filed annual report on Form 10-KSB and quarterly report on Form
10-Q, and other factors detailed from time to time in filings with
the Securities and Exchange Commission. We expressly disclaim any
responsibility to update forward-looking statements.
Contact: ONI BioPharma Inc. Stanley B. Stein 386-418-4018 X222
www.onibiopharma.com
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