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 Date of Report (Date of earliest event reported) March 19, 2001 --------------- Aastrom Biosciences, Inc. - -------------------------------------------------------------------------------- (Exact name of registrant as specified in charter) Michigan 0-22025 94-3096597 - -------------------------------------------------------------------------------- (State or other jurisdiction (Commission (IRS Employer of incorporation) File Number) Identification No.) 24 Frank Lloyd Wright Drive, P.O. Box 376, Ann Arbor Michigan 48106 - -------------------------------------------------------------------------------- (Address of principal executive offices) (Zip Code) Registrant's telephone number, including area code (734) 930-5555 ---------------------- Not Applicable -------------------------------------------------------------- (Former name or former address, if changed since last report)
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)
EXHIBIT INDEX ------------- 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
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
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 . Germany offers near-term revenue 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