ONI
BIOPHARMA INC.
December
19, 2008
Audio
Release Script
Good
afternoon, ladies and gentlemen this is Dr. Jeffrey Hillman. I’m
the Chief Scientific Officer of ONI BioPharma, and I would like to
welcome you to ONI BioPharma’s audio release addressing recent frequently asked
questions. Before I introduce Stanley Stein, who is the Chief
Executive Officer of the Company, I would like to give you the usual
caveats required by law.
First, I’d like to remind everyone that
the answers to the frequently asked questions contain certain statements
regarding the Company’s plans and expectations which are forward-looking
statements within the meaning of Section 27A of the Securities Act of 1933, as
amended, and Section 21E of the Securities Exchange Act of 1934 as amended and
are made pursuant to the Safe Harbor provisions of the Securities Litigation
Reform Act of 1995. ONI BioPharma intends for these forward-looking statements
to be covered by the Safe Harbor provisions for forward-looking
statements. In addition, words such as “anticipates,” “expects,”
“intends,” “plans,” “believes,” “seeks,” “estimates,” “should,”
“would,” and “will” or variations of such words
and similar expressions are intended to identify such forward-looking
statements.
These
statements are not guarantees of future performance and are inherently subject
to risks, uncertainties, and other factors, many of which are beyond the
Company’s control, which could cause actual results and outcomes to differ
materially from those contained in the forward-looking statements. Consequently,
the information we provide in the forward-looking statements made in these
answers to FAQs should not be viewed as indicative of our performance in future
periods. The “Risk Factors” sections of our annual and quarterly
reports discuss important factors that we are currently aware of that could
cause or contribute to differences between the forward-looking statements made
in these answers to FAQs and our actual results,
All
forward-looking statements are made as of December 19, 2008 and ONI BioPharma
expressly disclaims any obligation to update, amend or clarify them other than
as may be required by law. Risks that can cause actual results to differ
materially from those set forth or implied by any forward-looking statements can
be found in ONI BioPharma’s filings with the Securities and Exchange Commission
(SEC) which are available at www.sec.gov.
This
audio release does not constitute the offering of any securities for sale. The
Company's securities may not be offered or sold absent registration under
applicable securities laws or an exemption from registration. Any public
offering of the securities of the Company will be made by means of a prospectus
that will contain detailed information about the offering and the
Company.
The
answers to FAQs in this audio release will remain available on our web site
until December 30, 2008. In addition, contemporaneously with the
posting of these answers to FAQs on our web site, a transcript of these answers
is being filed with a Form 8-K and will be available on the web site
of the Securities and Exchange Commission, www.sec.gov.
Now I’d
like to introduce Stanley Stein, Chief Executive Officer of ONI BioPharma and
begin the question and answer.
General
FAQs
What
are the four business divisions the Company currently operates?
ONI
BioPharma is a multi-faceted biopharmaceutical company. As a result of the
transformation and strategic initiatives we determined to undertake, the Company
now consists of four distinct divisions: the Consumer Products division with
Probiora3™, Evora™ and LPT3-04™; the Diagnostic division with PIVIAT™ and PCMAT™
platform technologies; the Antibiotics division with DPOLT™ lantibiotic
synthesis platform; and the Replacement Therapy with SmaRT™ Replacement Therapy
technology.
All of
these divisions present unique and different potential opportunities for the
Company which we are actively working on pursuing. In this regard,
ONI BioPharma has made great strides operationally over the past several months
with respect to each separate division.
When
does the Company expect to generate revenue?
We expect
to generate revenue from consumer products in 2009 both in the U.S. and
internationally. This revenue is expected to help support our Diagnostic,
Antibiotic and Replacement Therapy divisions in the future, however the Company
will need to raise additional funding in order to fully execute its business
strategy. The Company is currently evaluating various funding
alternatives.
FAQs regarding recent
developments and strategic initiatives
What
are the significant recent developments in the Consumer Products
division?
The
Consumer Products initiative is moving forward rapidly with the launch of
products branded from our Probiora 3™ product technology. This
technology provides us with a pipeline of potential products under our Evora
brand name. This pipeline includes the EvoraPlus™ for the general
consumer market, EvoraPet™ for the pet markets, particularly cats and dogs; and
EvoraKids™, for prevention of dental caries in children. During the fourth
quarter we are very pleased to have received initial orders for EvoraPlus™ . We
anticipate the next Evora product that we will launch will be EvoraPet™ in the
second or third quarter of 2009.
In
addition to the Consumer Products provided by our Probiora 3™ technology we have
our small molecule weight management for which we filed a U.S. patent
application, which is referred to by us as LPT3-04™. LPT3-04™ is a
naturally occurring substance. Our strategy for this weight
management agent is similar to that with our probiotic. We plan on
developing a bifurcated strategy in which we market the technology as an active
ingredient for licensing or provide labeling while we also develop a house brand
to market to consumers directly and through mass retail, including
configurations for the pet market. We are currently in the process of
developing a delivery system for LPT3-04™ with a goal of optimizing consumer
satisfaction and expected weight loss results. We expect to launch our initial
weight management product in the second quarter of 2009.
What
progress has the Company made regarding the launching of EvoraPlus™ ?
We
believe ONI has made significant progress regarding the launch of EvoraPlus™.
ONI has three primary channels in which it will market EvoraPlus™: (1) Mass
Retail, (2) Direct to Consumer (“DTC”), or (3) Dental Professionals. Regarding
the Mass Retail channel, ONI has retained an experienced team of brokers to
market the product to the largest retailers in the United States. Several
initial meetings with several major retailers have already taken place. As
mentioned, several initial orders have been received. ONI also plans on
marketing through one or more television shopping networks in the next quarter.
In the DTC channel, a one-minute spot television ad is currently in production
and will run in key markets once product manufacturing has been completed. ONI
has also developed an Internet strategy to market the product directly through
our www.evoraplus.com
website. We have made significant progress in meeting with Dental Professionals
as well. Lastly, we plan on aggressively marketing our products in Mexico and
Latin America through our recently-formed Mexican Subsidiary. We anticipate that
we will begin selling and distributing EvoraPlus™ in Mexico in the first half of
2009.
Since our
Consumer Products have Generally Recognized as Safe or “GRAS” status, we will
not incur the regulatory cost and time associated with the FDA approval process.
This significantly reduces our costs and allows us to bring our products to
market much quicker for faster generation of potential revenue.
What
are the significant recent developments in the Diagnostic division?
Another
strategic initiative we are currently focused on is our Diagnostic division
through our PIVIAT™ and PCMAT™ platforms, to generate targets associated with
the natural onset and progression of infections, and other diseases in humans,
animals and agriculture products. The first major commercial effort
that we have undertaken utilizing the PCMAT™ platform has been to extract
genetic targets from tissue samples containing colorectal
cancer. Colorectal cancer affects millions of people
worldwide. The current screening method of choice in the detection of
colorectal cancer is the use of a colonoscopy. Due to the invasive
nature and cost of colonoscopies, patient compliance is low. As such,
many cases of bowel cancer go undetected until the cancer has reached an
advanced stage. Using the PCMAT™ diagnostic platform, we have
discovered what we believe to be unique genetic markers that appear during the
earliest stages of colorectal cancer. As announced, 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™ platform. We are excited and optimistic
about this initial collaborative effort and the possibilities for these
diagnostic platforms.
We have
also initiated a new internal program for both the PIVIAT™ and PCMAT™
platforms. Under this initiative we expect to 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. Our goal is to further validate and reduce the number of markers
for each platform. The further we can refine the markers in development the more
value we believe can be realized in a future sale, joint venture or licensing
arrangement with testing companies or other health care entities.
What
are the significant recent developments in the Antibiotics
division?
The
cornerstone of our Antibiotics division is the DPOLT™ (which is Differentially
Protected Orthogonal Lantionine Technology) Synthetic Chemistry Platform, which
affords us the ability to synthesize a unique class of antibiotics known as
lantibiotics.
This
platform will enable large scale, cost effective production of clinical grade
MU1140 and 50 other known lantibiotics. DPOLT™ is anticipated to lead
to 6-10 new antibiotics with novel mechanisms of action. This
represents a substantial potential pipeline of antibiotics to replace ones that
are currently declining in efficacy due to the development of bacterial
resistance.
Although
there are now over 50 different known lantibiotics, this is the first report of
a cost-effective method for producing one in sufficient amounts and with
sufficient purity to enable comprehensive testing and commercial
viability.
This
initial antibiotic is very closely related to ONI’s lead antibiotic, MU 1140,
which has the potential to treat a wide variety of infections, including those
caused by MRSA and other drug resistant Gram positive
bacteria. Domestically, hospital-borne infections have been on the
rise, with an estimated two-million patients contracting dangerous infections
annually leading to one-hundred-thousand deaths. Preliminary studies
also indicate that MU 1140 may be the first new antibiotic in 35 years for the
treatment of tuberculosis. In addition to MU 1140, this technology
will allow us to synthesize all 50 of the known lantibiotics and to conveniently
modify their structures in order to improve their usefulness as antibiotics for
the treatment of infectious diseases.
As a
first step in further development, the Company has retained Almac Sciences, a
leading contract manufacturer, to refine and scale-up GMP production of the
synthetic MU 1140 analog to achieve sufficient quantities to permit full testing
for regulatory approval. It is estimated that the regulatory process
will take a minimum of three years before this drug could become
available. Other lantibiotics are expected to follow as they are
developed and tested.
Our
ability to conduct such trials will depend on the availability of funding for
the trials. We will also be able to scale production such that it
will be sufficient to allow us to commercialize synthetic MU
1140. Only after all phases of FDA clinical trials, or equivalent
clinical trials required by other regulatory bodies, have been successfully
completed and we have received the appropriate approvals will we be in a
position to begin marketing.
What
are the recent developments in the Replacement Therapy division and the
Company’s international strategic initiatives?
We have
developed a comprehensive, global strategy. Although we are domiciled in the
United States, we feel that there are numerous advantages in utilizing overseas
talent and markets for a variety of our products and technologies. Some of the
initiatives that are currently in progress are:
France and elsewhere in
Europe: ONI also expects to pursue several initiatives in France and
elsewhere in Europe. For example, ONI is in discussions with the key
French agencies and authorities about the establishment of significant
operations in France, after receiving appropriate regulatory
approvals. The Company further expects to conduct clinical trials for
a number of products in France and elsewhere in Europe. The plan would be to
have our products registered in all EU countries once approved in France.
Lastly, ONI plans on establishing a major marketing initiative in Europe for its
Consumer Products. These products would also be expected to be manufactured in
Europe.
Mexico: We recently
formed 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 expect to begin
marketing EvoraPlus™ in Mexico as soon as regulatory approval is
achieved. We will also initiate further clinical trials for our
SMaRT™ 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
Biolotecnología, Universidad Nacional Autónoma de México (or “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
PCMATTM
platforms. We are encouraged by the initial interest and prospects presented by
this move for our replacement therapy and as we have indicated, we believe
Mexico provides us with a unique avenue to possibly expedite the regulatory
approval process for our SMaRT Replacement Therapy and thereafter have
replacement therapy enter the market place and begin to provide the benefits we
anticipate can be experienced from it.
We
believe we are making tremendous strides in dealing strategically with the
approval process, however, please do not forget that some of our strategic
initiatives are in a highly regulated product environment and while we are doing
everything we can to expedite the testing and regulatory review processes there
can be no assurance given as to when the Mexican government’s approval process
will be satisfactorily completed and provide us with the opportunity to market
our replacement therapy product or other technologies. We also
believe that the Mexican market provides us with an opportunity to market our
other products and presents an opportunity to launch into other markets by way
of Mexico’s treaties with other countries.
South America :
ONI is exploring partnerships or strategic collaborations in Chile, which may
lead to the licensing of its products in Chile or further collaboration similar
to that in Mexico.
Mutual Recognition:
We are contemplating several strategies that will allow us to leverage our
Subsidiaries and expedite or facilitate entry into alternative markets. One such
example is through mutual recognition. Our Mexican Subsidiary
will utilize Mexican treaty benefits with Spain in furtherance of the
commercialization of its products in Spain. Utilizing EU mutual recognition
provisions, ONI and its subsidiaries will further commercialize its consumer
products and diagnostic platforms in other EU member states.
FAQs Regarding the OTC.BB
and trading in the Company’s common stock
Where
will quotations for the Company’s stock be available in the U.S.?
Effective
December 22, 2008, quotations for the Company’s common stock will be available
on the OTC Bulletin Board in the United States.
What
is the OTC Bulletin Board (OTC.BB)?
The
OTC.BB is a quotation service for securities. NASDAQ operates the OTC.BB service
and permits FINRA members to quote any OTC security that is current in its
required SEC regulatory filings. However, the OTC.BB is not part of
NASDAQ and securities quoted on the OTC.BB are not listed on
NASDAQ.
What
are the eligibility requirements for the OTC.BB and who are our market
makers?
In order
for a security to be eligible for quotation by a market maker on the OTC.BB, the
security must be registered with the SEC and the issuer must be current in its
required filings with the SEC. A market maker must sponsor the
security before it can initiate a quote in a specific security on the
OTC.BB. Our market makers are Murphy Durier and GunnAllen
Financial.
How
do I buy or sell stock quoted on the OTC.BB?
The
process of buying or selling OTC.BB stock is the same as buying or selling any
other stock. You must open an account with a broker (a party that executes buy
and sell orders). You cannot buy OTC.BB stock directly from the OTC.BB or the
OTCBB.com.
What
is the Company’s OTC.BB stock symbol?
The
Company’s stock symbol is “ORNI”.
Where
can I find price quotes for the company’s stock?
You
should be able to find quotes from the same sources you previously used other
than AMEX.
You can
also obtain quotes at OTCBB.com.
FAQs For French
Investors
What
is a direct listing?
If a
company is listed on another exchange, it may carry out a direct listing on
Alternext, with no capital raising.
What
is the benefit of a direct listing? Why in France?
Alternext
was created to allow small and midsized companies to access the financial
markets through an alternative route that has easier requirements and meets
their aims and aspirations. Alternext is tailored to the needs of small- and
mid-caps that wish to come to the equity market and benefit from streamlined
listing conditions.
Companies
having made a direct listing on Alternext are not required to make a
simultaneous public offering. By meeting minimum listing requirements, ONI did
not have to file a prospectus requiring approval by the French securities
regulator, the Autorité des marchés financiers (AMF), but rather just an
offering circular. Therefore, the admission procedure was short (about a
month).
ONI’s
management chose Alternext because of the organizational structure of Alternext,
which can be considered as a next generation market that has a real policy to
attract innovative companies by offering a broad range of support and services
in connection with their listing.
ONI’s
decision to list in Paris, in light of the current market conditions, was a
strategic move for the growing company. Listing on Alternext Paris grants ONI
direct access to a whole new sector of investors and significantly expands its
potential for capital growth.
This
listing made ONI the first US-based company to be traded on Alternext Paris,
which is part of the leading platform in Europe for biotechnology companies. As
a result of such listing, ONI is included in the NYSE Euronext Next Biotech
index (www.euronext.com/nextbiotech).
Why
such timing?
ONI’s
Alternext Paris listing is an integral part of the ambitious commercial strategy
we have implemented. In particular, ONI has now begun sales in the United States
of EvoraPlusTM, its
first probiotic that helps maintain dental and oral health, designed for the
general consumer market.
The
Alternext Paris listing demonstrates ONI’s confidence in the success of the
launching of EvoraPlusTM and its
willingness to be seen as a major and long-term player through the combination
of its international listing and the future marketing of its other products in
the United States and internationally.
Will
a French institutional or individual shareholders be able to buy ONI shares in
France without being overcharged with brokerage fees? How will the trading
volume in France be established?
As is the
case for other companies listed on Alternext, French investors may place their
orders through their usual broker. The brokerage fees should be the same as for
other companies listed on Alternext.
ONI’s
shares are traded through a daily call auction held at 3:30 pm. The settlement
takes place three days after the trading, as is the case for any operation on
the Paris stock market.
ONI is
not eligible to benefit from the Deferred Settlement Service (SRD), or to be
included in a French Individual Retirement Account (PEA).
FAQs on long-term
prospects
What
are the Company’s long term prospects?
Obviously,
we remain very optimistic about the company's long term prospects. Our core
business initiatives are doing well and are on track and we have
commercialization initiatives underway with additional products in the pipeline.
And again we're not forgetting the need to continue to focus on strong cost
controls as well as improving our cash position.
Ladies
and gentlemen, that's the end of the audio release and thank you for
listening.