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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 15, 2005
Aastrom Biosciences, Inc.
(Exact name of registrant as specified in its charter)
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Michigan
(State or other
jurisdiction of
incorporation)
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0-22025
(Commission File No.)
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94-3096597
(I.R.S. Employer
Identification No.) |
24 Frank Lloyd Wright Drive
P.O. Box 376
Ann Arbor, Michigan 48106
(Address of principal executive offices)
Registrant’s telephone number, including area code:
(734) 930-5555
Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the
filing obligation of the registrant under any of the following provisions:
o Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)
o Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)
o Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR
240.14d-2(b))
o Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR
240.13e-4(c))
TABLE OF CONTENTS
Item 7.01 Regulation FD Disclosure.
Attached hereto as Exhibit 99.1, which is incorporated herein by reference, is a copy of
certain slides used by the Company in making presentations to interested parties, including at
investment conferences and 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. Any information in this report supercedes inconsistent or outdated
information contained in earlier Regulation FD disclosures.
Item 9.01 Financial Statements and Exhibits.
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| Exhibit No. |
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Description |
99.1
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Slides used in presentation |
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.
Date: March 15, 2005
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AASTROM BIOSCIENCES, INC.
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By: |
/s/ Alan M. Wright
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Alan M. Wright |
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Senior Vice President, Administrative and
Financial Operations, CFO |
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exv99w1
Exhibit 99.1
| Proprietary Cell Products for |
| Investor Presentation
March, 2005 (Nasdaq:ASTM) |
| z This presentation contains forward-looking statements, including, without
limitation, statements concerning product-development objectives and anticipated timing,
clinical trial timing and results, potential market opportunities and revenue models, market
development plans, anticipated key milestones and potential advantages and applications of the
AastromReplicell® System and related products, which involve certain risks and
uncertainties. Actual results may differ significantly from the expectations containedin the
forward-looking statements. |
| z Among the factors that may result in differences are the results obtained from
clinical trials and development activities, regulatory approval requirements, competitive
conditions and availability of resources. |
| z These and other significant factors are discussed in greater detail in Aastrom’s
Annual Report on Form 10-K and other filings with the Securities and Exchange Commission. |
| z Emerging as a leading tissue regeneration company |
| z Proprietary bone marrow stem cell products: Tissue Repair Cells |
| z Business model based on clinical experience and ability to apply TRCs to multiple
markets |
| z Phase II-level trials now active for two bone graft indications, with third
planned in 2005 |
| z Additional Phase II-level trial for diabetic limb ischemia expected to begin in
2005 |
| z Multiple clinical milestones expected over next 12-18 months |
| z Good financial position |
| Capturing the Therapeutic Potential of Bone Marrow Stem Cells |
| Regenerate tissues with stem cells grown from bone marrow collected from the patient... |
| What’s Unique About Aastrom |
| Proprietary adult stem cells and industry-unique manufacturing capability... |
| Proprietary AastromReplicell System Tissue Repair Cells |
| z Bone marrow-derived adult stem & progenitor cells z Cell
production automation with (non-embryonic) GMP compliance |
| z Bone, vascular, blood, cartilage and adipose |
| z 12-day fixed production cycle forming capability |
| z Produced ex vivo with patented single-pass perfusion technology
z Point of care or centralized |
| z Proven safety and tissue generation in > 180 patients manufacturing
capability |
| ... the Transformation of Technology into Products |
| Maximizing Regenerative Capability |
| Early Stem Multi-Lineage Precursor Mature Late |
| Stage Cells Progenitor Cells Cells Cells Stage |
| Best Regeneration Effectiveness Least |
| Aastrom Tissue Repair Cell Product |
| New Capability in Tissue Regeneration |
| TRCs Multi-Lineage z Bone |
| Stem/Progenitor z Vascular |
| Small aspirate Cells go to TRCs produced in TRCs used to generate |
| collected from patient production lab AastromReplicell System healthy tissues |
| TRC products are designed |
| just like pharmaceuticals $ |
| Transforming Cells into Products |
| Tissue Repair Cell Patient-Specific Cell |
·
| Products Developed for Manufacturing and Percutaneous Bone Treatments |
| Multiple Indications Distribution |
| Business Infrastructure & Marketing Alliances |
| Development Pipeline
Research Preclinical Clinical Market Comments
Bone Grafting
Long bone fractures
U.S. Phase I/II Trial enrolling at 4 sites
Europe Enrolling –Spain & Germany
Jaw reconstruction Enrolling –Spain
(Sinus lift for dental implants) |
| Spine fusions Clinical protocol in development |
| Peripheral limb ischemia Pending Agreement with HDZ –Germany |
| Cardiac ischemia Animal model underway |
| Joint reconstruction Cartilage from TRCs established |
| Dendritic cell vaccine production; |
| DC-I, DCV-I and DCV-II Kits CE Marked Available in U.S. and EU |
| Aastrom Tissue Repair Cells |
| Active Lead Product Indications |
| Product Applications Clinical Status |
| • Fracture Long bone fractures 120,000 U.S./EU: Active |
| • Jaw Sinus lift 205,000 EU: Active |
| • Spine Spine fusions 330,000 Preclinical |
| • Ischemia Diabetic limb 560,000 Pending |
| * Sources: Datamonitor 2002; Millennium Research Group CY2009 projections; U.S. Census
2000; United Nations 2002 World Population Report; Weitz JI, Byrne J, Clagett P, et al.
Diagnosis and Treatment of Chronic Arterial Insufficiency of the Lower Extremities: A
Critical Review. Circulation 1996; 94: 3026-49. (U.S., Europe and Japan) |
| Potential for TRCs in Bone Grafting |
| Bone Graft Product Comparison
Conceptual Model for Severe Indications
Therapy Effectiveness Morbidity Cells
Autograft
+++ high ++
(Gold Standard) |
| Alternatives Matrix (variable) high |
| DBM = Demineralized Bone Matrix
BMP = Bone Morphogenic Proteins |
| Conceptual Product Use Model |
| Bone Injury Scale Non-Union |
| Fracture Low Range of Severity High |
| Fixation Fusion
Lead Matrix Products |
| Approach Autograft
Aastrom TRCs |
| Bone Graft Market Opportunity |
| Global Market: 2 Million Bone Grafts Annually |
| Source: Millennium Research Group CY2009 projections (U.S., Europe and Japan) |
| BMP = Bone MorphogenicProteins |
| DBM = Demineralized Bone Matrix |
| Bone Fracture Indications |
| Bone Fracture Indications |
| – Lead studies underway in Spain and Germany |
| – First phase (6 treatments) completed in Barcelona; trial |
| expanding based on progressive healing and safety results |
| – Process logistics working well
z United States |
| – Phase I/II multi-center trial; IND approved by FDA |
| – Safety milestone achieved, allowed to expand to fresh and |
| long-term non-union fractures |
| – Four sites currently active; 1 more expected by mid-CY2005 |
| – If results acceptable, plan to move to Phase III |
| Combining TRCs and Matrix Micrograph of TRCs in Matrix |
| Non-Union Fracture Trial
Candidate Patient X-Rays *
Point
of
Fracture |
| * Clinical Situation: Non-union fracture of humerus which failed |
| fixation and autograft (> 8 months) |
| Fracture Site with Previous Fixation Removed |
| Fracture Site with New Fixation Applied |
| TRCs and Matrix Applied at Fracture Site |
| Post-Treatment Patient Recovery (4 Months) |
| Jaw Reconstruction Indication |
| Jaw Reconstruction Indication |
| – Lead trial for dental implant (sinus lift) initiated in Spain |
| – 5 patient study; enrollment complete |
| – Bone formation measured by biopsy/histology and compared to |
| standard bone graft approach in same patient |
| – Expect results by end of 2Q CY2005
z United States |
| – Hold until EU trial data available |
| Limb Ischemia (Veins and Arteries) |
| Rationale for TRC Development |
| z Large market opportunity, with limited therapeutic competition |
| – Diabetic and Buerger’s disease patients |
| – Targeted 2 million patients in need of surgery for severe
limb ischemia |
| – Reimbursement levels are high for interventional treatments |
| Published clinical results suggest effectiveness of large volume
bone marrow for limb ischemia |
| –Similar reports for cardiac ischemia
z TRCs ready to go to trial |
| – TRC’s vascular lineage capability demonstrated in vitro |
| – Leverage existing infrastructure established for bone
grafting |
| – TRCs shown as effective substitute for large volume bone
marrow in BMT indication (Aastrom trials) |
| Source: Millennium Research Group CY2009 projections (U.S., Europe and Japan) BMT = Bone
Marrow Transplantation |
| Effect of Large Volume Bone Marrow |
| Sources: Lancet 360: 427-435, 2002 (left panel) |
| Eur J. Vasc Endovasc Surg 00, 1-3, 2002 (right panel) |
| Vascular Tissue Clinical Plan |
| Limb Ischemia Indication
z EU |
| – Clinical trial agreement with HDZ in Bad Oeynhausen, Germany
– Cell manufacturing license process initiated
– Patient accrual expected to begin mid-CY2005 |
| – Phase I NIH grant supported circulation ischemia research
– Vascular forming capability of TRCs demonstrated
– Pursuing grants for further research development |
| – Largest provider of allograft tissue matrix (>$250 million revenue) |
| – Companies both contribute to development and clinical expenses
for products that combine TRCs and MTF matrix |
| – Companies sell their own products and coordinate marketing |
| z Targeting other relationship(s) for synthetic matrix |
| z Targeting other marketing partners for each indication |
| – Fracture; Jaw; Spine; Vascular |
| Aastrom Balance Sheet Data |
| (December 2004 –Proforma *)
z Cash and Investments $37,500,000 |
| z Total Assets $39,400,000 |
| z Shareholders’Equity $38,800,000 |
| z Average Cash Usage Per Month $1,000,000 |
| * Includes $12 million gross proceeds from an equity transaction in |
| January 2005, and $2.9 million gross proceeds from previously
31 issued warrants exercised through February 3, 2005 |
| Proprietary Cell Products for Tissue Regeneration |
| Investor Presentation
March, 2005 (Nasdaq:ASTM) |
