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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) May 30, 2003
Aastrom Biosciences, Inc.
| Michigan | 0-22025 | 94-3096597 | ||
| (State or other jurisdiction of incorporation) |
(Commission File Number) |
(IRS Employer 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
| Item 5. Other Events. | ||||||||
| Item 7. Financial Statements and Exhibits. | ||||||||
| SIGNATURES | ||||||||
| EXHIBIT INDEX | ||||||||
| EXHIBIT 99.1 | ||||||||
| EXHIBIT 99.2 | ||||||||
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Item 5. Other Events.
On May 30, 2003, Aastrom issued two press releases. The first press release, filed herewith as Exhibit 99.1, relates to a collaborative agreement with Stanford University for a new therapeutic approach for cancer therapy that would combine Aastrom’s patented single-pass perfusion cell production technology with Stanford’s Cytokine Induced Killer cell technology. The second press release, filed herewith as Exhibit 99.2, relates to receipt of the anticipated notification from Nasdaq as to failure to satisfy Nasdaq’s minimum bid price requirements and the Company’s intent to appeal the Nasdaq staff’s determination, which has the effect of suspending the delisting process.
Item 7. Financial Statements and Exhibits.
| Exhibit | ||
| No. | Description | |
| 99.1 | Press Release of May 30, 2003 relating to collaborative agreement with Stanford | |
| 99.2 | Press Release of May 30, 2003 relating to notification from Nasdaq |
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: May 30, 2003 | Aastrom Biosciences, Inc. | |||
| By: | /s/ Alan M. Wright | |||
| Senior Vice President, Administrative and Financial Operations, CFO |
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EXHIBIT INDEX
| Exhibit | ||
| No. | Description | |
| 99.1 | Press Release of May 30, 2003 relating to collaborative agreement with Stanford | |
| 99.2 | Press Release of May 30, 2003 relating to notification from Nasdaq |
EXHIBIT 99.1 (AASTROM LOGO) FOR IMMEDIATE RELEASE CONTACTS: Kris M. Maly or Becky Anderson Investor Relations Department Aastrom Biosciences, Inc. Phone: (734) 930-5777 AASTROM BIOSCIENCES AND STANFORD UNIVERSITY ANNOUNCE IMMUNOTHERAPY COLLABORATION FOR HODGKIN'S DISEASE ANN ARBOR, MICHIGAN, MAY 30, 2003 -- Aastrom Biosciences, Inc. (NasdaqSC: ASTM) announced today that it has entered into a collaborative agreement with Stanford University (Stanford) for a new therapeutic approach for cancer therapy. The collaboration will combine Aastrom's patented single-pass perfusion (SPP) cell production technology with Stanford's Cytokine Induced Killer (CIK) cell technology to produce cells designed to trigger an immune system attack on a patient's tumor cells. CIK cells are a subset of the immune system's T-lymphocytes. When grown in culture using cytokines and an activating antibody, the cultured CIK cells have the ability to destroy tumor cells. A clinical study to evaluate the use of CIK cells in patients with Hodgkin's disease and other cancers will be conducted at the Stanford University Medical Center under the direction of Robert Negrin, M.D., Director, Division of Bone Marrow Transplantation. Dr. Negrin has published extensively on CIK cells and their anti-tumor activity, and has approved clinical protocols for the investigation of CIK cells in the treatment of Hodgkin's lymphoma and other cancers, such as leukemia and lymphoma. Unlike conventional treatments, such as chemotherapy, the use of CIK cells may provide a tumor-specific, relatively non-toxic approach to treating cancer by triggering a natural immune system response against the cancer. The same approach may be used to treat many types of cancers and to augment the results after all types of hematopoietic stem cell transplants. The ability to produce highly functional and reliable human cells for therapeutic use is Aastrom's specialty. For this study, Aastrom's patented SPP process, along with components of its AastromReplicell(TM) System platform, will be used to enable the ex vivo production of the CIK cells under Good Manufacturing Practices (GMP) conditions. This project complements Aastrom's ongoing activities utilizing this same technology for the production of dendritic cell cancer vaccines, another form of immunotherapy. The Company previously announced its collaboration in the dendritic cell vaccine area with Dr. Ronald Levy, also at Stanford. This study was reviewed in an article in the May 23, 2003 issue of the Wall Street Journal, on Page 1 of the Marketplace section. "We believe cell-based immunotherapies are among the most exciting new investigational approaches in cancer treatment. Aastrom provides a unique resource needed for producing these cells, placing us in an important strategic position in this field," said R. Douglas Armstrong, Ph.D., President, Chief Executive Officer and Chairman of Aastrom. "It is the Company's plan to collaborate in as many studies as possible, such as those of Dr. Negrin and Dr. Levy at Stanford, to assist the progress of these important new clinical investigations and to broaden the reach of our business opportunities by participating in the development of a successful cancer therapy." ABOUT AASTROM BIOSCIENCES, INC. Aastrom Biosciences, Inc. (NasdaqSC: ASTM) is a late-stage development company focused on human cell-based therapies. The AastromReplicell(TM) System - a patented, integrated system of instrumentation and single-use consumable kits for the production of patient-specific cells - is the Company's core technology for its Prescription Cell Products (PCP) business and its Cell Production
Aastrom-Stanford CIK Study May 30, 2003 Page 2 Products (CPP) business. The principal focus of the PCP business is the repair or regeneration of tissue intended for large markets such as bone grafting and severe osteoporosis. The CPP business markets the AastromReplicell(TM) System to researchers and companies for their production of cells for clinical trials. These two businesses are intended to enable Aastrom to generate multiple paths to revenue. The initial commercial phase of the CPP business for dendritic cell production products is underway in Europe and the United States. For more information, visit Aastrom's website at www.aastrom.com. THIS DOCUMENT CONTAINS FORWARD-LOOKING STATEMENTS, INCLUDING WITHOUT LIMITATION, STATEMENTS CONCERNING ANTICIPATED RESULTS OF THE COLLABORATIVE AGREEMENTS, PRODUCT DEVELOPMENT OBJECTIVES, POTENTIAL PRODUCT APPLICATIONS, AND POTENTIAL ADVANTAGES OF THE AASTROMREPLICELL(TM) SYSTEM, WHICH INVOLVE CERTAIN RISKS AND UNCERTAINTIES. THE FORWARD-LOOKING STATEMENTS ARE ALSO IDENTIFIED THROUGH USE OF THE WORDS "INTENDED," "MAY," "PLAN," "POSSIBLE," "BELIEVE," AND OTHER WORDS OF SIMILAR MEANING. ACTUAL RESULTS MAY DIFFER SIGNIFICANTLY FROM THE EXPECTATIONS CONTAINED IN THE FORWARD-LOOKING STATEMENTS. AMONG THE FACTORS THAT MAY RESULT IN DIFFERENCES ARE THE UNCERTAINTIES INVOLVED IN CLINICAL INVESTIGATIONS AND PRODUCT DEVELOPMENT ACTIVITIES, THE AVAILABILITY OF RESOURCES AND THE ALLOCATION OF RESOURCES AMONG DIFFERENT POTENTIAL USES. 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. ###
EXHIBIT 99.2 (AASTROM LOGO) FOR IMMEDIATE RELEASE CONTACTS: Kris M. Maly or Becky Anderson Investor Relations Department Aastrom Biosciences, Inc. Phone: (734) 930-5777 AASTROM BIOSCIENCES RECEIVES NASDAQ LETTER OF NON-COMPLIANCE - COMPANY'S APPEAL WILL SECURE NASDAQ LISTING THROUGH HEARING PROCESS - ANN ARBOR, MICHIGAN, MAY 30, 2003 - As expected and required by current rules, Aastrom Biosciences, Inc. (NasdaqSC: ASTM) has now received notification from Nasdaq of non-compliance with the $1 minimum bid price requirement. The notice was given on May 28, 2003. Aastrom will file an appeal of this Staff Determination to the Nasdaq Listing Qualification Panel by June 4th and, as previously announced, has developed a multiple-option plan of action that could enable the Company to meet the minimum bid requirement. During the appeal process, and until such time as the Nasdaq Panel issues a final decision, Aastrom will continue to trade under the symbol `ASTM' on the Nasdaq. The $1 minimum bid price requirement for continued listing is set forth in Nasdaq Marketplace Rule 4310(c)(4). "Aastrom has been prudently managing its cash position. We are making great strides in product development and in the marketing of those products. We were able to report revenues on European product sales in the second and third quarters, and anticipate additional revenues going forward. In addition, we have been successful in raising $3.7 million of cash from the sale of stock since last quarter. This brings our cash on hand today to approximately $7.4 million," said Alan M. Wright, Chief Financial Officer and Senior Vice President Administrative and Financial Operations of Aastrom. "Management believes that Aastrom is a company with tremendous potential, demonstrated by these achievements and its longevity in the life sciences industry. It is our intention to protect these achievements, and the loyalty of our shareholders, by maintaining our listing as a Nasdaq company." Aastrom, although in receipt of this letter, still trades on the Nasdaq SmallCap exchange, and will continue to do so until Nasdaq has held a hearing, and issues its response to Aastrom's proposal and request for extension. Part of Aastrom's presentation to the Nasdaq Listing Qualification Panel will be the Company's plan for continued Nasdaq listing. Aastrom views its options as one or more of the following, with the final selection to be made based on the facts and the circumstances at the time of the hearing: - Request an extension of time allowing management to execute business transactions, such as capital formation or a strategic alliance, that could result in the market lifting the stock price above the required minimum. - Request an extension until such time that Aastrom could seek the approval of its shareholders to perform a reverse split, to raise the price of its stock well above the one dollar minimum requirement. - Request an extension until such time as the Securities and Exchange Commission (SEC) acts on the pending request by Nasdaq to permit further extensions for compliance with bid price rules that if approved as proposed, could extend the minimum bid price deadline up to 270 days for Aastrom, as long as the Company satisfies other continued listing criteria. -more-
Aastrom-Nasdaq Letter May 30, 2003 Page 2 - Request to be moved to the OTC Bulletin Board where Aastrom stock could continue to trade without having to comply with the $1 minimum bid listing requirement. Additionally, Nasdaq's planned electronic bulletin board, the BBX, when operational, could provide companies that meet other core requirements, like Aastrom, an alternative Nasdaq listing option. There can be no assurances that the Nasdaq Panel will accept the Company's proposal regarding continued listing, or that the Company could comply with any conditions established by the Nasdaq Panel. Furthermore, the Company is currently pursuing additional sources of funding. If the Company cannot obtain additional funding prior to or during the first quarter of the fiscal year beginning July 2003, it will likely make substantial reductions in the scope and size of its operations, and may curtail activities, in order to conserve cash until such funding is obtained. Management expects the Nasdaq Listing Qualification Panel hearing to be scheduled within approximately 30 to 45 days. After the hearing, it may take several weeks to receive the decision of the Nasdaq Panel, during which time Aastrom will continue to be traded on the Nasdaq SmallCap exchange. ABOUT AASTROM BIOSCIENCES, INC. Aastrom Biosciences, Inc. (NasdaqSC: ASTM) is a late-stage development company focused on human cell-based therapies. The AastromReplicell(TM) System - a patented, integrated system of instrumentation and single-use consumable kits for the production of patient-specific cells - is the Company's core technology for its Prescription Cell Products (PCP) business and its Cell Production Products (CPP) business. The principal focus of the PCP business is the repair or regeneration of tissue intended for large markets such as bone grafting and severe osteoporosis. The CPP business markets the AastromReplicell(TM) System to researchers and companies for their production of cells for clinical trials. These two businesses are intended to enable Aastrom to generate multiple paths to revenue. The initial commercial phase of the CPP business for dendritic cell production products is underway in Europe and the United States. For more information, visit Aastrom's website at www.aastrom.com. THIS DOCUMENT CONTAINS FORWARD-LOOKING STATEMENTS, INCLUDING WITHOUT LIMITATION, STATEMENTS CONCERNING POTENTIAL ACTIONS BY NASDAQ AND THE SEC, EUROPEAN PRODUCT SALES, CAPITAL RAISING ACTIVITIES AND CONSEQUENCES, PRODUCT DEVELOPMENT OBJECTIVES, POTENTIAL PRODUCT APPLICATIONS, AND POTENTIAL ADVANTAGES OF THE AASTROMREPLICELL(TM) SYSTEM, WHICH INVOLVE CERTAIN RISKS AND UNCERTAINTIES. THE FORWARD-LOOKING STATEMENTS ARE ALSO IDENTIFIED THROUGH USE OF THE WORDS "EXPECT," "MAY," "PLAN," "COULD," "BELIEVES," "ANTICIPATE," "INTENTION," "INTENDED," "POTENTIAL," "CAN," AND OTHER WORDS OF SIMILAR MEANING. ACTUAL RESULTS MAY DIFFER SIGNIFICANTLY FROM THE EXPECTATIONS CONTAINED IN THE FORWARD-LOOKING STATEMENTS. AMONG THE FACTORS THAT MAY RESULT IN DIFFERENCES ARE THE TIMING AND SUBSTANCE OF DECISIONS MADE BY NASDAQ AND THE SEC, THE RESULTS OF PRODUCT MARKETING ACTIVITIES CONDUCTED BY THIRD PARTIES, ACTIONS TAKEN BY MARKETING PARTNERS AND COMPETITORS, MARKET PRICES FOR THE COMPANY'S STOCK, THE AVAILABILITY OF RESOURCES AND THE ALLOCATION OF RESOURCES AMONG DIFFERENT POTENTIAL USES. 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. ###