UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
FORM 8-K
CURRENT REPORT
Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934
Michigan 0-22025 94-3096597
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(State or other jurisdiction (Commission (IRS Employer
of incorporation) File Number) Identification No.)
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Item 7. Financial Statements and Exhibits.
Exhibit No. Description --- ----------- 99 Slides used in presentations |
Item 9. Regulation FD Disclosure.
Attached hereto as Exhibit 99, which is incorporated herein by reference, is a copy of certain slides used by the Company in making presentations to analysts and shareholders. This information is not "filed" pursuant to the Securities Exchange Act and is not incorporated by reference into any Securities Act registration statements. Additionally, the submission of this report on Form 8- K is not an admission as to the materiality of any information in this report that is required to be disclosed solely by Regulation FD.
SIGNATURES
Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.
Aastrom Biosciences, Inc.
Date: March 20, 2001 By: /s/ Todd E. Simpson
------------------------------
Vice President, Finance & Administration
and Chief Financial Officer (Principal
Financial and Accounting Officer)
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Exhibit No. Description --- ----------- 99 Slides used in presentations |
Aastrom
Biosciences Inc.
[ARTWORK APPEARS HERE]
New Life
from
New Technology
SAFE HARBOR
This presentation contains forward-looking statements, including without limitation statements concerning product development objectives, market development plans, Aastrom's business model for its products, clinical trial timing and anticipated results, potential revenues and markets for Aastrom's products and products under development, and potential advantages and applications of the AastromReplicell(TM) System, which involve certain risks and uncertainties. Actual results may differ significantly from the expectations contained in the forward-looking statements.
Among the factors that may result in differences are the results obtained from clinical trials and development activities, regulatory approval requirements, competitive developments and the availability of resources.
These and other significant factors are discussed in greater detail in Aastrom's Annual Report on Form-10K and other filings with the Securities and Exchange Commission.
Aastrom Biosciences, Inc.
Company Overview
Situation: Proliferation of new
discoveries and opportunities
for cells as therapeutic agents
Aastrom: Developing and
commercializing proprietary
products to enable and
standardize general medical
access to therapeutic cells
Cell Therapy
Commercialization Pathway
Research
Lab
[ARTWORK APPEARS HERE]
. Bone Marrow
. Cord Blood Cells
. Stem Cells
. T-cells
. Chondrocytes Patient
. Neuronal Cells
. Dendritic Cells
|
Aastrom's Patented Single-Pass
Perfusion Technology
Superior Cell Biology Capability
. Enabled stem cell replication
(bone marrow, cord blood)
. Enhanced cell replicative potential
(T-cells)
. Enhanced cell function
(T-cells, dendritic cells, endothelial cells)
. Enhanced cell production
(bone marrow, cord blood, chondrocytes,
mesenchymal stem cells)
|
Cell Therapy
Commercialization Pathway
Research AastromReplicell(TM) System
Lab
[ARTWORK APPEARS HERE]
. Bone Marrow
. Cord Blood Cells
. Stem Cells
. T-cells
. Chondrocytes Patient
. Neuronal Cells
. Dendritic Cells
|
Aastrom Cell Therapeutics |
Based on Two Proprietary Platforms
Patented Single- Patented GMP Pass Perfusion System Automation Processes for Human Cell Growth |
AastromReplicell(TM) System
Aastrom Cell
Therapeutics
Aastrom Cell Therapeutics
Market Access Plan
Aastrom Cell
Therapeutics
Therapeutic Cell Therapeutic Cell Therapeutic Cell
Manufacturing Manufacturing Manufacturing
by Aastrom by Hospitals by Strategic
Partners
$ From Sale of $ From Sale of
Therapeutic Cell Cell-Specific
Products Therapy Kits
|
AastromReplicell(TM) System |
Meeting Market Needs
. A unique, turn-key medical product platform that provides a standardized capability for high quality therapeutic cell production
. Automated, GMP compliant, production of cells with excellent biologic function compared to standard culture approaches in bags/flasks
. Dual business model for pharmaceutical-type revenue stream through sales of:
-single-use therapy-specific kits, or
-proprietary cells produced using ARS
AastromReplicell(TM) System Platform
Automated Cell Production
[PHOTO APPEARS HERE] [PHOTO APPEARS HERE]
AastromReplicell(TM) System
Therapy Kit Single-Use Components
Cell Application Liquid
Cassette Key Products
[PHOTO APPEARS HERE] [PHOTO APPEARS HERE] [PHOTO APPEARS HERE]
. sterile fluid . therapeutic cell . therapeutic cell
pathway specific specific growth
program medium
. used for all cell software
types . added to cell
. attaches to cell cassette with
cassette cell inoculum
. programs the
instruments
|
AastromReplicell(TM) System |
Therapy Kits
. Single-use product to produce a specialized mixture of cells to treat a specific medical indication
. Provides automated cell production under closed-system, GMP compliance
. Enables Aastrom to get paid for each patient therapy procedure (when customer generates the cells)
. Enables Aastrom to uniquely produce specialized therapeutic cell products
Aastrom Cell Therapeutics
CY 2001 Regulatory Status
Product Target Europe US
------- ------ ------ --
SC-1 (stem cells) Solid Cancers Approved Phase III
CB-1 (cord blood) Leukemia Approved Phase III
OC-1 (bone cells) Osteoporosis -- Phase I/II
CB-II Leukemia -- Phase I
DC-1 (dendritic cells) Cancers Clin. Res Clin. Res.
TC-I (t cells) EB virus -- Pre-clinical
|
Aastrom Cell Therapeutics
Target Markets (US/Europe)
Potential
Product Disease Candidates Market
------- ------- ---------- ------
SC-I Solid Cancers 15,000
$110 M
CB-I Leukemia 35,000 $250 M
CB-II Leukemia+ 45,000 $335 M
OC-I Osteoporosis 350,000 $1500 M
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OC-I Cell Product Development Plan |
. Aastrom preclinical studies demonstrating bone progenitor cell production completed
. Transplant (compassionate use) of genetic bone disease patient with OC-I cell product, proved successful in restoring bone density
. Phase I/II feasibility trial in patients with severe osteoporosis now underway
Aastrom Cell Therapeutics
Target Markets (US/Europe)
Potential
Product Disease Candidates Market
------- ------- ---------- ------
SC-I Solid Cancers 15,000
$110 M
CB-I Leukemia 35,000 $250 M
CB-II Leukemia+ 45,000 $335 M
OC-I Osteoporosis 350,000 $1500 M
DC-I Cancers 150,000+ $1200 M
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Immunotherapy Markets Dendritic Cells |
. Vaccines for cancer are becoming a reality
. Based on use of cells from the immune system educated ex vivo to target the patients tumor
. Most current focus is on use of blood derived Dendritic Cells
. Aastrom's technology is targeted to play a key product role in this industry
DC-I Cell Product
Product Objective
. A versatile dendritic cell product to accommodate widely used dendritic cell vaccine approaches
. Combines:
- ARS automated process control, and
- Aastrom's patented single-pass perfusion
to enable reliable, cost-effective production of high quality dendritic cells for vaccine
use
Dendritic Cell Immunotherapy
Strategic Approach
DC-I Patient
Dendritic Cells + specific
(blood derived) tumor antigen
(tumor cells,
Ex Vivo lysates, mRNA or
peptides)
Tumor-specific
activated dendritic
cell
Induction of
T-cell specific
response Irradication of
in vivo malignant
disease
In Vivo
|
DC-I Cell Product
Meeting Market Needs
. Alternative manual cell production
procedures are complex and generally
lack required outcome reliability
. DC-I cell product is for standardized
general vaccine use, produced using
process controlled automation
. DC-I cell product has excellent outcome
reliability and biological performance
. DC-I cell product obviates the need for
expensive cell selection products
|
Dendritic Cell Manufacturing
Manual vs DC-I Therapy Kit
Set-Up & Media
Adherence Exchange Harvest Total
--------- -------- ------- -----
15 to 25 T-225 Flasks
---------------------
Processing Time (Hr.): 5.5 2.5 3.5 11.5
Open Culture Steps: 120 40 80 240
DC-I Cell Product
-----------------
Processing Time (Hr.): 1.0 N/A 1.25 2.25
Aseptic Culture Steps: 1 0 1
|
DC-I Cell Product
German Clinical Research Market
. Multiple site trials ongoing in multiple types of cancer
. Some companies already selling vaccines
. Leading providers have current demand for equivalent of 3 to 6 DC-I cell products per week
. Several sites preparing for a 3x to 5x increase in dendritic cell demand
. Number of providers expected to increase as more clinical results are generated
. 2001-2002 Customer Goal: 6 to 10 Sites
DC-I Cell Product
Market Development Plan
. Commercialize the DC-I cell product in key vaccine centers in Germany (start in 2H 2001)
. Expand into European market (2002)
. Commercialize DC-I cell product into
leading US clinical research programs
(begin 2H 2001)
. Plan US trial for selected Aastrom vaccine(s)
. Negotiate strategic partnerships for additional vaccine trials with DC-I cell product
Targeted Lead Collaborators/Customers
DC-I Cell Product
. Charite Mitte (Berlin, Gr)
. University of Goettingen (Gr)
. University of Tuebingen (Gr)
. Dana-Farber Cancer Center/Beth Israel
. Karmanos Cancer Institute (Detroit, MI)
. Duke University Medical Center
. Medac GmbH (ILH GmbH)
. BioWhittaker/Cambrex
Aastrom Biosciences, Inc.
Plan for Building Shareholder Value
. Build Aastrom cell therapeutic product business using our two proprietary technology platforms
. Move our approved stem cell therapy products into the market in Europe, and then the US
. Aggressively pursue major dendritic cell therapy/vaccine global market
- launch product in German market near- term
. Pursue new cell therapies for bone diseases (such as osteoporosis)
. Leverage new strategic partnership potential
Aastrom
Biosciences Inc.
[ARTWORK APPEARS HERE]
New Life
from
New Technology