Table of Contents
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
PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934
Date of report (date of earliest event reported):
August 25, 2005
August 25, 2005
Aastrom Biosciences, Inc.
(Exact name of registrant as specified in its charter)
| Michigan | 0-22025 | 94-3096597 | ||
| (State or other jurisdiction of incorporation) |
(Commission File No.) | (I.R.S. Employer Identification No.) |
24 Frank Lloyd Wright Drive
P.O. Box 376
Ann Arbor, Michigan 48106
(Address of principal executive offices)
P.O. Box 376
Ann Arbor, Michigan 48106
(Address of principal executive offices)
Registrant’s telephone number, including area code:
(734) 930-5555
(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. | ||||||||
| Item 9.01 Financial Statements and Exhibits. | ||||||||
| SIGNATURES | ||||||||
| EXHIBIT 99.1 | ||||||||
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 a presentation to potential investors and that are
expected to be used in subsequent presentations to interested parties, including 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report supercedes inconsistent or outdated information contained in earlier Regulation FD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.
| (c) | Exhibits. |
| Exhibit No. | Description | |
99.1
|
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: August 25, 2005 |
||||
| AASTROM BIOSCIENCES, INC. | ||||
| By: | /s/ Gerald D. Brennan, Jr. | |||
| Gerald D. Brennan, Jr. | ||||
| Vice President, Administrative and | ||||
| Financial Operations, CFO | ||||
2
Exhibit 99.1
| Proprietary Cell Products for Tissue Regeneration (Nasdaq:ASTM) Investor Presentation August, 2005 |
| This presentation contains forward-looking statements, including, without limitation, statements concerning product-development objectives and anticipated timing, clinical trial timing and expected results, potential market opportunities and revenue models, market development plans, anticipated key milestones and potential advantages and applications of Tissue Repair Cells (TRCs), 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 conditions and availability of resources. 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. SAFE HARBOR |
| Summary Emerging as a leading tissue regeneration company Proprietary bone marrow stem cell products: Tissue Repair Cells Business model based on clinical experience and ability to apply TRCs to multiple markets In clinic with multiple Phase II-level trials for bone grafting New Phase II-level trial for diabetic limb ischemia to begin 2005 Multiple clinical milestones expected over next 18 months 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... |
| Tissue Repair Cells: Bone Marrow Plus Small aspirate collected from patient Office procedure Cells go to production lab Centralized facility TRCs generate healthy tissues > 180 patients treated to date TRCs produced in AastromReplicell System Proprietary technology |
| Aastrom Tissue Repair Cell Product TRCs Multi-Lineage Stem/Progenitor Cells Bone Vascular Others Growth Factor Production BMPs VEGF SCGF Others Bone Marrow Derived Cells Natural Tissue Regeneration Process New Capability in Tissue Regeneration |
| Aastrom's Business Model TRCs Aastrom Core Business Infrastructure Tissue Repair Cell Products Developed for Multiple Indications Patient-Specific Cell Manufacturing and Distribution Development & Marketing Alliances Bone Grafting Fractures Jaw Reconstruction Spine Fusion Limb Ischemia Future Percutaneous Bone Treatments Cardiac Ischemia Cartilage Transforming Cells into Products |
| Development Pipeline Research Preclinical Clinical Market Comments U.S. Europe Jaw reconstruction - Europe (Sinus lift for dental implants) Spine fusions Long bone fractures Bone Grafting Vascular Tissue Cardiac ischemia Peripheral limb ischemia Trial enrolling at 5 sites Positive results reported Results expected in CY2005 IND submitted to FDA Successful animal model completed Accruing patients in 3Q CY2005 Cartilage Joint reconstruction Cartilage from TRCs established Phase I/II Proof of Concept Proof of Concept Phase I/II |
| TRCs in Bone Grafting Complete Phase I/II trials to establish ability of TRCs to induce bone growth in three bone types (long bone, spine, facial) Select indication to continue Phase III level trials for market registration (FDA in US; EMEA in EU) Explore additional trials to expand market potential and labeling Clinical Strategy |
| Potential for TRCs in Bone Grafting |
| Autograft Allograft & DBM BMPs Synthetics East 0.48 0.27 0.09 0.16 TRCs East 0.05 0.95 Bone Graft Market Opportunity Target the Autograft Segment for Severe Indications Source: Millennium Research Group CY2009 projections (U.S., Europe and Japan) BMP = Bone Morphogenic Proteins DBM = Demineralized Bone Matrix TRCs 5% of Autograft > $200 Million Opportunity Global Market: 2 Million Bone Grafts Annually |
| TRCs for Bone Grafting Bone Fracture Indications |
| Bone Graft Clinical Plan EU Lead proof of concept study initiated in Spain in 2Q CY2004 Long term non-union fractures (failed standard treatment) First phase (6 treatments) completed; positive trial results reported May 2005 Process underway to expand trial United States Phase I/II multi-center trial; IND approved by FDA Safety milestone achieved; allowed to expand to fresh as well as long term non-union fractures Five sites now active; 20 patient target Targeted accrual/treatment completion in 4Q CY2005 Bone Fracture Indications |
| TRCs and Matrix 200mm Combining TRCs and Matrix Micrograph of TRCs in Matrix |
| Non-Union Fracture Trial * Clinical Situation: Non-union fracture of humerus which failed fixation and autograft (> 8 months) Candidate Patient X-Rays * Point of Fracture |
| Non-Union Fracture Trial Fracture Site with Previous Fixation Removed |
| Non-Union Fracture Trial Fracture Site with New Fixation Applied |
| Non-Union Fracture Trial TRCs and Matrix Applied at Fracture Site TRCs and Matrix |
| Non-Union Fracture Trial Patient Recovery (5 Months) Fracture Site |
| TRCs for Vascular Tissue Limb Ischemia Indication |
| Limb Ischemia (Veins and Arteries) Large market opportunity, with limited therapeutic competition Diabetic and Buerger's disease patients Targeted 1+ 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 TRCs ready to go to trial TRCs shown as effective substitute for large volume bone marrow in BMT indication (Aastrom trials) TRC's vascular lineage capability demonstrated in vitro Leverage existing infrastructure established for bone grafting Rationale for TRC Development Source: Millennium Research Group CY2009 projections (U.S., Europe and Japan) BMT = Bone Marrow Transplantation |
| Limb Ischemia 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 Lead Trial (Phase II Level) Clinical trial agreement with HDZ in Bad Oeynhausen, Germany Cell manufacturing license process obtained and patient accrual to begin in CY2005 Trial Objectives Evaluate TRCs vs Bone Marrow vs Standard of Care to increase vascularization and aid in various standard vascular endpoints Endpoints: Improved ulcer healing, limb mobility, limb salvage, pain, ABI, plus other secondary evaluations Evaluate local IM injection and IA infusion routes Complete 25 patients, evaluate data for protocol modifications, and expand with selected criteria as a randomized trial Limb Ischemia Indication ABI = Ankle-Brachial Index IM = Intramuscular IA = Intraarterial |
| Partnering 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 Targeting other relationship(s) for synthetic matrix Targeting other marketing partners for each indication Fracture; Jaw; Spine; Vascular 2003 alliance with |
| Aastrom Balance Sheet Data (March 31, 2005 *) Cash and Investments $ 35,400,000 Total Assets $ 37,000,000 Shareholders' Equity $ 36,200,000 Average Cash Usage Per Month $ 1,000,000 * Per Aastrom Biosciences, Inc. Form 10-Q for quarter ended March 31, 2005 |
| Proprietary Cell Products for Tissue Regeneration (Nasdaq:ASTM) |