Attached files
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| 8-K - FORM 8-K - Riot Blockchain, Inc. | appy_8k-101509.htm |
| EX-99.2 - POWER POINT - Riot Blockchain, Inc. | ex99_1.htm |
Exhibit 99.1
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AspenBio
Pharma Progress Update
October
15, 2009
Dear
Fellow Shareholders,
This
has been an exciting year for AspenBio Pharma and I would like to take
this opportunity to provide you an update on our progress and plans for
the months ahead.
Before
deciding to join AspenBio about eight months ago, I spent considerable
time assessing the potential of both its human and animal product
pipeline—especially AppyScore™ —as well as the resources and capabilities
within the company.
Since
then, I have had the opportunity to delve more deeply into each of these
areas, and my enthusiasm about the potential of AspenBio has only
increased over time. I remain confident our products can make a meaningful
impact both clinically and scientifically, and in doing so, provide due
rewards to those who have supported the company throughout its
development.
We’ve
been making tremendous progress in our mission and I would like to
highlight some of our operational accomplishments and plans, and then
discuss our progress and plans related to AppyScore and animal
reproductive health, specifically.
Organizational
Highlights and Goals
Prior
to my arrival, AspenBio had already begun to strengthen its leadership
with the addition of several highly qualified and experienced board
members. The makeup of the board was an influencing factor in my decision
to join the company, and their contribution has played an important role
in accelerating our progress.
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This
has affirmed my belief that to build a successful company and create
appreciable value for shareholders, it is imperative we assemble the best
talent and resources possible. This includes appointing individuals for
each mission critical leadership role who actually “have done this
before.”
This
approach also makes our organizational goals fairly straight
forward:
1. Build
a highly qualified management team to make the best decisions while
executing our strategy;
2. Where
necessary, source complementary outside talent that has significant domain
expertise; and finally,
3. Provide
this team with the appropriate structure and support to
succeed.
Over
the past several months we have successfully added internal and external
talent with these qualifications. I am very pleased with the capabilities
of the current team we have assembled. We have also continually evaluated
our needs for support and resources to ensure continued progress, and such
evaluation has included the capitalization of the company to ensure we
have the funding to achieve our goals.
The
executive team, working with outside professional advisors, recently
completed a strategic plan which has been reviewed with and is supported
by our Board of Directors. In this plan we:
· Assessed
and identified various go-to-market options and defined a
commercialization plan
supported by market studies and a detailed forecast model;
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· Defined
product development milestones and supply initiatives for AppyScore to
ensure that,
with FDA approval, the product will be in a position to be delivered with
the
performance characteristics desired;
· Reevaluated
and refocused our regulatory strategy and pathway;
· Laid
out and prioritized a multigenerational product development plan
for AppyScore;
· Better
defined the animal health business opportunity and leadership strategy so
that we could
begin further co-development discussions with possible interested parties
including our
strategic partner, Novartis Animal Health;
· Identified
important organizational and talent gaps which have now been substantially
filled
for the key leadership positions; and
· Built
a business model with a road map focused on performance and enhancing
shareholder value.
We
recognize that with any product development company there are risks
associated with achieving its objectives. But with the organization we are
putting in place, we are confident our management team has the experience
and ability to mitigate risk and achieve success.
To
support the business plan we recently announced the completion of the sale
of 5,155,000 common shares, generating gross proceeds of approximately
$8.8 million. We believe that this funding was an important
step for the company to take. The offering proceeds restore our
cash position to almost 20 months at our current burn rate and provide a
cushion to allow us to focus on and work towards achieving FDA regulatory
clearance of the AppyScore product.
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AppyScore
One
of AspenBio’s key value drivers is the potential power of the AppyScore
patented assay to change medical practice in the diagnosis and / or
evaluation of human appendicitis patients around the world.
In
December 2008, the pivotal trial for AppyScore was completed, and in June
of this year we filed the Premarket Notification 510(k) with the U.S. Food
and Drug Administration (FDA) for the AppyScore ELISA test.
In
August, we received a request from the FDA for additional information
related to this 510(k) application. In consultation with our regulatory
consultants, Becker & Associates Consulting, and prior to the 510(k)
application filing, we had determined the FDA might request additional
data and information. We also concluded that we might want additional
research data for our future commercial product claims. To ensure we would
be in a position to provide the FDA with responses to any requests, and be
on the best track toward commercialization, we decided to proceed
proactively with certain additional analyses and testing, including
supplemental trial work, all of which are underway.
This
additional analysis and testing was started in parallel with the FDA’s
initial review, and the implementation of the new study is proceeding as
planned. While we cannot guarantee the outcome or that the additional
information we will be providing to the FDA will successfully address all
of their inquiries, we believe we are well positioned to do
so.
In
June 2009, we formed a Medical Advisory Board (MAB) for AppyScore. The
independent members of our MAB are recognized leading thinkers and
innovators in the fields of surgery, emergency medicine, health research
and policy—the disciplines most directly involved with diagnosing and
treating appendicitis.
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Our
MAB members, along with our market research and pricing study consultants,
continue to support our belief that AppyScore, upon FDA approval and
product launch, will fill a significant unmet need in the evaluation and
management of patients suspected of having appendicitis, particularly
aiding in the rule out of those without the disease. This belief has been
further affirmed by the direct feedback from emergency department
physicians, surgeons, and insurance providers, as well as other key
opinion leaders in our industry.
While
we continue to advance the work needed to respond to the FDA’s inquiries
on our 510(k) submission for our AppyScore ELISA test, we are also
advancing the development of AppyScore in a cassette and instrument
format. This is the product format that we plan to ultimately launch as
the commercial product following its FDA clearance.
The
rapid assay cassette and instrument system offers many features and
benefits over an ELISA-based test, including:
· Rapid
results as compared to the ELISA test process;
· Integratable
to a hospital’s Laboratory Information System (LIS); and
· A
simplified format that significantly reduces operator dependence and
corresponding
potential for errors.
We
plan to commence clinical trials in early 2010 using the rapid assay
cassette and then in mid to late 2010, submit a separate 510(k) for this
system using the ELISA format of the AppyScore test as the predicate
device, assuming the ELISA test has received clearance.
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We
are planning for a cassette and reader commercial product launch following
FDA clearance of our cassette and reader system.
Over
the past 60 days we have added two key individuals to assist AspenBio in
advancing the cassette and reader on its path to
commercialization. Greg Bennett was added as Vice President of
Product Development and Manufacturing and brings 25 years of experience in
product design and development focused in cassette and instrument test
formats, most recently heading Cholestech’s operations following
Cholestech’s acquisition by Inverness Medical Innovations, Inc., in
2007. Dr. Mary Nunnally joined us as Vice President -
Quality with approximately 20 years experience in quality and operations
management in the medical device, biomedical research product and
pharmaceutical industries.
As
part of the strategic plan process described above, we evaluated the
product commercialization options, and have concluded that marketing
AppyScore initially in the US with our own or a contracted sales force is
the best commercialization strategy. Marketing focused on the top 30 US
metropolitan areas (which represent more than 40% of the potential market)
appears very manageable, and by going direct we can maximize the pricing
potential and profit opportunity. With this in mind, we anticipate
completing related manufacturing and supply agreements with leading
manufacturers by the end of the year.
We
recognize that this will not be easy or inexpensive. However, in
conjunction with a comprehensive plan to reach the key opinion leaders,
including physicians, policy makers, payers, providers, and most
importantly, patients, we believe we can fully capitalize on this
substantial market opportunity. Most importantly, this strategy has the
highest potential to create the best value for our
shareholders.
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Animal
Health
As
a general rule, the animal health sector is not as highly valued in the
public market place as the human health sector. However, the regulatory
approval process and cost of development for animal drugs and diagnostics
are less onerous than for human-directed products and
services.
To
provide leadership in the animal health sector of AspenBio’s business we
have just announced that we have added Dr. Andy Peters as Vice President
of Animal Health. Dr. Peters’ 30 years of experience in the
animal health market includes significant experience successfully
completing regulatory, business development, strategic alliance and
technology transfer activities. Dr. Peters recently spent eight years with
Pfizer Animal Health. We believe that under his dedicated
leadership the value associated with the animal health drugs that AspenBio
has will become better recognized.
The
first two recombinant drugs we expect to commercialize have been licensed
to Novartis Animal Health (NAH), a unit of Novartis (NYSE: NVS), for
co-development and worldwide market distribution. These drugs are designed
to enhance bovine reproduction. Under the leadership of NAH,
BoviPure LH™ and BoviPure FSH™ are steadily progressing toward FDA
clearance for animal drugs, and we are achieving key
milestones.
In
addition to the work being done with NAH on the bovine species, we have
evaluated and ranked the market potential of other animal species of
commercial interest and are currently in the development of recombinant LH
and FSH drugs for those top ranked species. We are also developing an
expanded strategy for advancing our animal health business to further
capitalize on these unique single-chain reproductive drugs which were
developed by Dr. Irving Boime and licensed from Washington University in
St. Louis.
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To
assist in advancing and making decisions regarding the animal product
development and commercialization strategy, we are reshaping our Animal
Health Scientific Advisory Board to bring on more thought leaders and
opinion makers in animal reproductive science. We expect to announce these
new appointments in due course.
Given
our progress and plans in all of these areas of our business, I am very
optimistic the coming months will continue to bring major milestones for
AspenBio Pharma.
I
would like to thank you for your continued support of AspenBio and the
positive vision we share for the future. For those interested
in following our progress we do maintain a power point presentation that
is updated periodically as developments arise which you can view on our
website under the investors/company overview section. If
you would like to view a recent investor webcast of a presentation that I
made to investors, please log onto the link:
http://www.wsw.com/webcast/tep16/appy/
I
look forward to seeing you at the annual shareholders’ meeting later this
year.
Sincerely,
Daryl
Faulkner
Executive
Chairman and CEO
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