Attached files
| file | filename |
|---|---|
| 8-K - FORM 8-K - Riot Blockchain, Inc. | appy_8k.htm |
| EX-99.2 - EXHIBIT 99.2 - Riot Blockchain, Inc. | ex99x2.htm |
| EX-99.3 - EXHIBIT 99.3 - Riot Blockchain, Inc. | ex99x3.htm |
Exhibit 99.1
November 28, 2011
NASDAQ: APPY
Corporate Presentation
2
NASDAQ: APPY
Important Cautions Regarding Forward-Looking Statements
Certain statements made in this presentation are "forward-looking statements" of AspenBio Pharma, Inc. (“AspenBio") as
defined by the Securities and Exchange Commission ("SEC"). All statements, other than statements of historical fact,
included in this presentation that address activities, events or developments that AspenBio believes or anticipates will or
may occur in the future are forward-looking statements. These statements are based on certain assumptions made based
on experience, expected future developments and other factors AspenBio believes are appropriate in the circumstances.
Such statements are subject to a number of assumptions, risks and uncertainties, many of which are beyond the control of
AspenBio. Investors are cautioned that any such statements are not guarantees of future performance. Actual results or
developments may differ materially from those projected in the forward-looking statements as a result of many factors,
including our ability to successfully complete required product modifications in a timely and cost effective manner, our
ability to successfully complete a pivotal clinical trial for AppyScore™ required for FDA submission, obtain FDA clearance,
cost effectively manufacture and generate revenues from AppyScore and other new products, execute agreements
required to successfully advance the company's objectives, retain the management team to advance the products,
overcome adverse changes in market conditions and the regulatory environment, obtain and enforce intellectual property
rights, and realize value of intangible assets.
defined by the Securities and Exchange Commission ("SEC"). All statements, other than statements of historical fact,
included in this presentation that address activities, events or developments that AspenBio believes or anticipates will or
may occur in the future are forward-looking statements. These statements are based on certain assumptions made based
on experience, expected future developments and other factors AspenBio believes are appropriate in the circumstances.
Such statements are subject to a number of assumptions, risks and uncertainties, many of which are beyond the control of
AspenBio. Investors are cautioned that any such statements are not guarantees of future performance. Actual results or
developments may differ materially from those projected in the forward-looking statements as a result of many factors,
including our ability to successfully complete required product modifications in a timely and cost effective manner, our
ability to successfully complete a pivotal clinical trial for AppyScore™ required for FDA submission, obtain FDA clearance,
cost effectively manufacture and generate revenues from AppyScore and other new products, execute agreements
required to successfully advance the company's objectives, retain the management team to advance the products,
overcome adverse changes in market conditions and the regulatory environment, obtain and enforce intellectual property
rights, and realize value of intangible assets.
Furthermore, AspenBio does not intend (and is not obligated) to update publicly any forward-looking statements. The
contents of this presentation should be considered in conjunction with the risk factors contained in AspenBio's recent
filings with the SEC, including its Quarterly Report on Form 10-Q for the period ended September 30, 2011.
contents of this presentation should be considered in conjunction with the risk factors contained in AspenBio's recent
filings with the SEC, including its Quarterly Report on Form 10-Q for the period ended September 30, 2011.
This presentation is © 2011 AspenBio Pharma, Inc., All Rights Reserved.
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NASDAQ: APPY
Our Focus: AppyScore
Ÿ AspenBio is developing AppyScore™, a blood-based “Rule-
Out” test for Acute Appendicitis in children and adolescents
Out” test for Acute Appendicitis in children and adolescents
Ÿ Designed to help physicians confirm if patients with
abdominal pain suspicious for appendicitis are at low to
moderate risk of the disease so they can be managed
conservatively
abdominal pain suspicious for appendicitis are at low to
moderate risk of the disease so they can be managed
conservatively
Ÿ Healthcare benefit: Fewer CTs = Reduced radiation
exposure
exposure
Ÿ Hospital benefit: Enhanced decision making, reduced cost
and increased workflow
and increased workflow
Ÿ Pilot study demonstrates effectiveness of AppyScore
Ÿ Solid regulatory pathway
Ÿ Substantial global market potential
Ÿ First mover advantage
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NASDAQ: APPY
Why Focus on the Diagnosis of Abdominal Pain?
Abdominal vs. Chest Pain as % of Total ER Visits
Patients >18 years in U.S., 1999-20081
1Trend is significant (p < 0.05). Figures are based on 2-year averages. Source: CDC/NCHS, National Hospital Ambulatory Medical Care Survey 1999-2008.
²NHAMCS Data, 2008 ( All reference to abdominal pain are regarding “non- traumatic” abdominal pain)
3 Emer Med Clinics of North Amer 2001; 19:123-136
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NASDAQ: APPY
…and Why Appendicitis?
Ÿ 3.1M CT Scans annually for abdominal
pain alone2
pain alone2
Ÿ 326K appendectomies in U.S. in 20072
Ÿ Children & adolescents represent peak
age group3
age group3
Ÿ Appendicitis affects 9% of males and of
7% females over lifetime3
7% females over lifetime3
1Ind J Radiol Imag 2006; 16:4:523-532
2Source: NHDS from CDC 2007 data
3Am Journal of Epidemiology, Addis et al. Johns Hopkins Vol. 132 no. 5
Appendectomy is #1 Reason for Emergency Abdominal Surgery1
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NASDAQ: APPY
Abdominal Pain Metrics
Patients Entering ER for Abdominal Pain & Receiving
Complete Blood Count Test (CBC) Annually (millions)
Complete Blood Count Test (CBC) Annually (millions)
Source of CBC data NHAMCS 2009
Greater than 50% of
patients suspected
of appendicitis are
children, adoles-
cents and young
adults
patients suspected
of appendicitis are
children, adoles-
cents and young
adults
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NASDAQ: APPY
Use of ER Abdominal CT Imaging is Rising Rapidly
• Use of advanced medical
imaging 1 for non-traumatic
abdominal pain is increasing
imaging 1 for non-traumatic
abdominal pain is increasing
• However, “liberal use of CT
scans in diagnosing
appendicitis in children has
not resulted in a decreased
negative appendectomy
rate”² (i.e., CT scans did not
decrease the removal of non-
diseased appendixes)
scans in diagnosing
appendicitis in children has
not resulted in a decreased
negative appendectomy
rate”² (i.e., CT scans did not
decrease the removal of non-
diseased appendixes)
Medical imaging (U.S.) in non-traumatic ER visits
Percentage per Symptom 1
Patients >18 years in U.S., 1999-2008
1 Includes CT, MRI and Ultrasound, ages 18 and older. SOURCE: CDC/NCHS, National Hospital Ambulatory Medical
Care Survey 1999-2008.
Care Survey 1999-2008.
² J Pediatr Surg. 2004 Jun;39(6):886-90; discussion 886-90.
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NASDAQ: APPY
Ÿ Children are highly vulnerable to the oncogenic, long
term effects of exposure to high doses of ionizing
radiation (i.e., from CT)
term effects of exposure to high doses of ionizing
radiation (i.e., from CT)
Ÿ Up to 2% of all U.S. cancers will be caused by CT1
Ÿ Earlier the exposure, the more likely to die from
cancer later in life (see chart below)
cancer later in life (see chart below)
1N Engl J Med 2007; 357:2277-84
2Larson et. al., Radiology Published online April 5, 2011
Lifetime Attributable Risk of Death from Cancer
per Million Patients Exposed to 10mCy
per Million Patients Exposed to 10mCy
Age at Exposure (yr)
“Our finding of a substantial increase in the use of CT in
children who visit emergency departments in the United
States underscores the need for special attention to this
vulnerable population to ensure that imaging is
appropriately ordered, performed, and interpreted.” 2
children who visit emergency departments in the United
States underscores the need for special attention to this
vulnerable population to ensure that imaging is
appropriately ordered, performed, and interpreted.” 2
CT Use in Children Increases Lifetime Cancer Risk
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NASDAQ: APPY
CT Usage Not Correlated with Appendicitis Risk
*Risk groups in the 2010 clinical study were based on a modified Alvarado scoring system (9 of the 10 Alvarado items) while the
risk groups in the 2011 pilot study were based on a new scoring system (3 of the 10 Alvarado items).
risk groups in the 2011 pilot study were based on a new scoring system (3 of the 10 Alvarado items).
The percentage of
patents suspected of
appendicitis who
received CT scans have
been very similar in both
the lower-to-moderate
and high-risk groups*
patents suspected of
appendicitis who
received CT scans have
been very similar in both
the lower-to-moderate
and high-risk groups*
10
Emergency Department Clinical Work Flow Today
Emergency Room
History , Physical Exam &
Risk Assessment Triage
Conservative Management
Signs & Symptoms
of Appendicitis
Appendectomy
?
Physician Decision
CT or US Imaging
11
Emergency Department Clinical Work Flow with AppyScore
Emergency Room
History , Physical Exam &
Risk Assessment Triage
CT or US Imaging
Signs & Symptoms
of Appendicitis
AppyScore Negative
Physician Decision
AppyScore
+
CT or Ultrasonic (“US”) imaging
anticipated to be used less
with negative AppyScore
patients
anticipated to be used less
with negative AppyScore
patients
Conservative Management
Appendectomy
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NASDAQ: APPY
AppyScore Intended Use & Value Proposition
AppyScore is intended to be used as an aid to rule out appendicitis in
pediatric and adolescent patients presenting with signs, symptoms and
medical history suggestive of having the disease.
pediatric and adolescent patients presenting with signs, symptoms and
medical history suggestive of having the disease.
Meets needs of emergency physicians & laboratory workflow
Ÿ Blood-based rule-out test
Ÿ Rapid Processing Time and throughput
Ÿ Data accessible to hospital via LIS
system
system
Ÿ Easy to deploy & use in any hospital
setting
setting
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NASDAQ: APPY
Recent FDA-Cleared Multi-marker vs. Single Marker Tests
|
FDA-Cleared
Test |
# Bio-
Markers |
Application
|
Sensitivity
|
Specificity
|
NPV
|
|
CA 125 1
|
1
|
Tumor
Marker (primarily Ovarian) |
77
|
68
|
87
|
|
Fujirebio -
ROMA 2 |
2
|
Ovarian
Cancer |
88
|
67
|
96
|
|
Vermillion -
Ova 11 |
5
|
Ovarian
Cancer |
94
|
35
|
93
|
1 Miller et al. Performance of the American College of Obstetricians and Gynecologists’ Ovarian Tumor Referral
Guidelines With a Multivariate Index Assay. Obstet Gynecol. 2011; 117(6): 1298-1306
Guidelines With a Multivariate Index Assay. Obstet Gynecol. 2011; 117(6): 1298-1306
2 Fujirebio press release. 6 Sept 2011
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NASDAQ: APPY
2011 AppyScore Pilot Study Summary
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NASDAQ: APPY
Results achieved using a
Multi-Marker Panel:
Multi-Marker Panel:
Ÿ MRP 8/14 (MRP)
Ÿ C-Reactive Protein (CRP)
Ÿ White Blood Cell Count
(WBC)
(WBC)
Results from 2011 AppyScore Pilot Study (431 Patients)
|
|
AppyScore Multi-Marker
Study |
|
|
|
Results
|
95% CI
|
|
Sensitivity
|
98%
|
94 - 100
|
|
Specificity
|
48%
|
42-53
|
|
NPV
|
99%
|
95 - 100
|
Appendicitis Prevalence 27%
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NASDAQ: APPY
Algorithm Methodology
When developing a diagnostic test, the goal is to maximize the
difference in results between patients that have the disease and
those who don’t.
difference in results between patients that have the disease and
those who don’t.
•Aspen has employed advanced proprietary and commercial
statistical software packages to discover combinations of
markers that exhibit exquisite sensitivity while maintaining
specificity near 50%
statistical software packages to discover combinations of
markers that exhibit exquisite sensitivity while maintaining
specificity near 50%
•We found the combination of three inflammation-related
markers enables very sensitive detection of the inflammatory
processes associated with appendicitis.
markers enables very sensitive detection of the inflammatory
processes associated with appendicitis.
•This combination is expressed as “AppyScore,” which is
calculated by a mathematical equation:
calculated by a mathematical equation:
a*WBC + b*CRP + c*MRP = AppyScore
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NASDAQ: APPY
Ÿ Verification Results Achieved
with Multi-Marker Panel:
with Multi-Marker Panel:
Ÿ MRP 8/14
Ÿ C-Reactive Protein
Ÿ White Blood Cell Count
Ÿ Analysis of Samples from 2008
Clinical Trial Verify
Performance Demonstrated in
2011 Pilot Study, even with
Clinical Trial Verify
Performance Demonstrated in
2011 Pilot Study, even with
substantial differences in trial
designs
AppyScore Verification on Independent Patient Set
* Based on a sample subset from 2008 clinical trial of 188
pediatric and adolescent patients suspicious for appendicitis
pediatric and adolescent patients suspicious for appendicitis
|
|
Multi-Marker Analysis*
|
|
|
|
Results
|
95% CI
|
|
Sensitivity
|
95%
|
87 - 98
|
|
Specificity
|
41%
|
34 - 50
|
|
NPV
|
95%
|
87 - 98
|
Appendicitis Prevalence 30%
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NASDAQ: APPY
AppyScore Product Profile
Physician
Orders
AppyScore
Orders
AppyScore
AppyScore Device
Measures CRP, MRP
Algorithm calculates AppyScore using MRP,
CRP, WBC values
CRP, WBC values
Hematology Analyzer
Determines WBC
+
21
NASDAQ: APPY
Intellectual Property Protection
Ÿ Multi-marker Coverage
Ÿ Provisional patent application filed Nov. 16, 2011
Ÿ Broad coverage for:
Ÿ Biomarker and WBC Panels
Ÿ Novel combination of variables
Ÿ Clinical Prediction Rule(s) + Panels
Ÿ Algorithms for AppyScore calculations
Ÿ Patents Secured for MRP 8/14
Ÿ Issued: U.S., Europe, and Japan
Ÿ Pending: Canada, China, India, and others
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NASDAQ: APPY
Regulatory Timeline
Product Development Timeline
AppyScore Estimated Timeline
Note: Date estimates are based on current information and expectations;
timeline may change due to regulatory input and other unforeseen factors
timeline may change due to regulatory input and other unforeseen factors
2011 2012 2013
FDA Pre-IDE
Meeting
Meeting
Complete Pivotal Trial
- Submit to FDA
- Submit to FDA
Commence
Pivotal Trial
Pivotal Trial
In Hospital
AppyScore
User Study
AppyScore
User Study
AppyScore Assay
Optimization
Optimization
Submit Final Protocol &
Statistical Analysis Plan
Statistical Analysis Plan
Complete
Analytical
Performance
Testing
Analytical
Performance
Testing
Finished
Product
Ready for
Pivotal Trial
Product
Ready for
Pivotal Trial
23
NASDAQ: APPY
Highly-Experienced Team - Strong Track Records of Success
§ Steve Lundy - President & CEO.
MicroPhage, GeneOhm Sciences (Acquired by BD),
Dianon Systems (Acquired by LabCorp), Bayer
MicroPhage, GeneOhm Sciences (Acquired by BD),
Dianon Systems (Acquired by LabCorp), Bayer
Commercial leadership in several high growth
diagnostic companies (Dianon, AVL, GeneOhm)
resulting in combined exit value of >$1 billion
diagnostic companies (Dianon, AVL, GeneOhm)
resulting in combined exit value of >$1 billion
§ Steve Tyrrell- Head of Research & Development.
Founder & CTO of Eveia Medical, VP R&D Biosafe
Laboratories, R&D Osborn Laboratories
Founder & CTO of Eveia Medical, VP R&D Biosafe
Laboratories, R&D Osborn Laboratories
Led the Research & Development of 10
commercial products with In Vitro diagnostics as
primary emphasis
commercial products with In Vitro diagnostics as
primary emphasis
§ Dr. Michael Wandell - Clinical & Regulatory Affairs.
Epigenomics, Benaroya Research Institute, Home Access
Health Corp., Genetic Systems
Health Corp., Genetic Systems
Seven major diagnostics cleared or approved by FDA;
extensive world-wide regulatory approvals
extensive world-wide regulatory approvals
§ Erik Miller - VP Marketing & Bus. Development.
Biosite (Acquired by Alere), Safety Syringes, & Luminex
Biosite (Acquired by Alere), Safety Syringes, & Luminex
Launched & managed Triage® line, UltraSafe® Safety
Devices, Luminex 200™ platform & consumable
(MagPlex®) key sustainable high-margin businesses
Devices, Luminex 200™ platform & consumable
(MagPlex®) key sustainable high-margin businesses
§ Dr. Mary Nunnally - Vice President Quality.
Ceragenix Pharmaceuticals, Invitrogen Corp., faculty at
Ceragenix Pharmaceuticals, Invitrogen Corp., faculty at
UT Southwestern Medical Center at Dallas
Led AspenBio’s recent efforts in ISO 13485 certification
Directors with Diagnostic Experience
§ John Landon - Prior director of Digene, chair of Cholestech,
and VP & General Manager, DuPont Medical Products
and VP & General Manager, DuPont Medical Products
24
NASDAQ: APPY
|
Summary Capitalization
|
|
|
Market Cap. (11/26/11)
|
$17.7M
|
|
Shares Outstanding
|
8.0M
|
|
Public Float, est.
|
7.8M
|
|
|
|
|
Ownership Summary
|
|
|
Institutional Holdings, est.
|
26.4%
|
|
Insider Holdings, est.
|
3.0%
|
(mrq) - most recent quarter as of September 30, 2011
Key Stats: APPY (NASDAQ CM)
|
Summary Balance Sheet
|
|
|
Cash & Equiv. (mrq)
|
$4.8M
|
|
Total Assets (mrq)
|
$10.0M
|
|
Total Liabilities (mrq)
|
$6.4M
|
25
AspenBio Key Takeaways
Ÿ AppyScore: Designed to help physicians confirm if
patients with abdominal pain suspicious for
appendicitis are at low to moderate risk of the disease
so they can be managed appropriately
patients with abdominal pain suspicious for
appendicitis are at low to moderate risk of the disease
so they can be managed appropriately
Ÿ Patient Benefit: Fewer CTs = Reduced radiation
exposure
exposure
Ÿ Hospital Benefit: Enhanced Decision Making, Reduced
Cost and Increased Workflow
Cost and Increased Workflow
Ÿ Pilot study demonstrates effectiveness of AppyScore
Ÿ Solid regulatory pathway
Ÿ Substantial global market potential
Ÿ First mover advantage
