Key Developments: Aastrom Biosciences Inc (ASTM.O)
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9 Feb 2010
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15,084,948
3,237,400
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Latest Key Developments
Aastrom Biosciences, Inc. Announces Closing of Unit Offering
Aastrom Biosciences, Inc. announced the closing of its previously announced underwritten public offering from which the Company received approximately $12.4 million in net proceeds from the sale of the units (including the partially exercised option of the over-allotment), after underwriting discounts and commissions and other offering expenses. The offering included the sale of 52,077,100 units in total at a public offering price of $0.26 per unit. Oppenheimer & Co. Inc. acted as the sole underwriter for the offering. The 52,077,100 units consist of 52,077,100 shares of the Company's common stock, Class A Warrants to purchase an aggregate of 39,057,825 shares of common stock and Class B Warrants to purchase an aggregate of 26,038,550 shares of common stock. Each whole Class A Warrant entitles the holder to acquire one share of the Company's common stock upon payment of $0.3718 per share, exercisable for a five year period commencing on a date six months after the closing date of the offering. Each whole Class B Warrant entitles the holder to acquire one share of the Company's common stock upon payment of $0.26 per share, exercisable for a six month period commencing on the closing date of the offering. The Company plans to use the net proceeds from the offering for general corporate purposes, including conducting operations and continuing to conduct the Company clinical development programs.
Aastrom Biosciences, Inc. Announces Pricing Of Unit Offering
Aastrom Biosciences, Inc. announced the pricing of its previously announced underwritten public offering of 46,154,000 units at a public offering price of $0.26 per unit. Each unit consists of one share of the Company's common stock, a Class A Warrant to purchase 0.75 of a share of common stock and a Class B Warrant to purchase 0.50 of a share of common stock. Each whole Class A Warrant entitles the holder to acquire one common share of the Company upon payment of $0.3718 per share, exercisable for a five year period commencing on a date six months after the closing date of the offering. In connection with the offering, the Company has also granted the underwriter a 30-day over-allotment option to purchase up to 6,923,100 shares of Common Stock, Class A Warrants to purchase 5,192,325 shares of Common Stock and/or Class B Warrants to purchase 3,461,550 shares of Common Stock. Oppenheimer & Co. Inc. acted as the sole underwriter for the offering. Net proceeds from the sale of the units, after underwriting discounts and commissions and other offering expenses, are expected to be approximately $10.9 million. If the underwriter exercises its over-allotment option in full, net proceeds from the offering will be approximately $12.7 million. The Company plans to use the net proceeds from the offering for general corporate purposes, including conducting operations and continuing to conduct our clinical development programs. The offering is expected to close on January 21, 2010.
Aastrom Biosciences, Inc. Announces Proposed Public Offering Of Units
Aastrom Biosciences, Inc. announced that intends to offer to sell, subject to market and other conditions, units consisting of shares of its common stock, Class A warrants and Class B warrants, in an underwritten public offering. Oppenheimer & Co. Inc. is acting as the sole underwriter for the offering. The Company intends to use the net proceeds of the offering for general corporate purposes, including conducting operations and continuing to conduct its clinical development programs.
Aastrom Biosciences, Inc. To Initiate Second Phase II Clinical Trial For Treatment of Severe Chronic Heart Failure
Aastrom Biosciences, Inc. announced that the Company will initiate its second clinical trial for the treatment of dilated cardiomyopathy (DCM), a severe disease associated with chronic heart failure, after a positive 30-day review of Aastrom's Investigational New Drug (IND) submission by the U.S. Food & Drug Administration (FDA). This second trial is a 24 patient U.S. Phase II clinical trial to evaluate the catheter delivery of Cardiac Repair Cells (CRCs) for the treatment of DCM. The new trial expands the Company's cardiovascular program that includes a U.S. Phase II IMPACT-DCM clinical trial evaluating the direct surgical delivery of CRCs. The randomized, controlled, prospective, open-label, Phase II study will seek to enroll 12 patients with ischemic DCM and 12 patients with non-ischemic DCM at two clinical sites in the U.S. Participants must have a left ventricular ejection fraction of less than or equal to 30% (60-75% is typical for a healthy person) and meet certain other eligibility criteria. All 24 patients will receive standard medical care and 16 of the patients (8 ischemic and 8 non-ischemic) will also be treated with CRCs via catheter injection. While the primary objective of this study is to assess the safety of CRCs delivered by catheter injection in patients with DCM, efficacy measures including heart failure stage and cardiac function parameters will also be assessed. Patients will be followed for 12 months post treatment.
Aastrom Biosciences, Inc. Announces Transitions in Senior Management
Aastrom Biosciences, Inc. announced that George W. Dunbar, currently Chief Executive Officer (CEO), President, Chief Financial Officer (CFO) and a Director of Aastrom, will transition out of day-to-day management and is expected to assume the role of Chairman of the Board immediately after the Company's Annual Meeting of Shareholders, currently planned for December 14, 2009. Timothy M. Mayleben, a member of the Company's Board of Directors and current Chair of the Audit Committee, will remain a Director and will become the new Chief Executive Officer, President and CFO in December 2009. Nelson M. Sims, who has served with distinction as Chairman of the Board of Directors since October 2008, is expected to assume the role of Lead Director.
Aastrom Biosciences, Inc. Announces FDA Lifts Clinical Hold From Heart Study-Reuters
Reuters reported that Aastrom Biosciences, Inc. said U.S. health regulators removed the clinical hold from the Company's mid-stage trial of a treatment for congestive heart failure. The Company said it would resume patient enrollment at all five initiated clinical sites. The FDA, the clinical site's principal investigator and an independent Data Safety Monitoring Board (DSMB) attributed the patient's death to progression of the disease and determined it was unrelated to the CRC treatment.
Aastrom Biosciences, Inc. Places Phase II IMPACT-DCM Clinical Trial On Hold Following Report Of Serious Adverse Event
Aastrom Biosciences, Inc. announced that it has temporarily suspended enrollment and patient treatment in its U.S. Phase II IMPACT-DCM clinical trial following a report that a patient died at home after being released from the hospital following treatment in the trial. The patient's cause of death has not yet been determined and is the subject of a pending investigation at the clinical site. An independent Data Safety Monitoring Board (DSMB) will also assess the circumstances of the event. In accordance with standard operating procedures, the Company has informed the U.S. Food and Drug Administration (FDA) of the following: the death of the patient after being released from the hospital; the initiation of an investigation into the cause of death; and that the Company has voluntarily suspended patient enrollment and treatment in the trial. Subsequently, the FDA placed the trial on temporary clinical hold pending an investigation. Follow-up of patients previously enrolled in the IMPACT-DCM trial will continue in accordance with study protocol.
FDA Removes Clinical Hold From Aastrom Biosciences, Inc. Phase II IMPACT-DCM Clinical Trial
Aastrom Biosciences, Inc. announced that the U.S. Food and Drug Administration (FDA) has removed the clinical hold from the Company's U.S. Phase II IMPACT-DCM clinical trial and that patient enrollment would resume at the four initiated clinical sites. The IMPACT-DCM trial is evaluating the use of Cardiac Repair Cells (CRCs), a mixture of stem and progenitor cells derived from a patient's own bone marrow, for the treatment of dilated cardiomyopathy (DCM), a severe form of chronic heart failure. The FDA informed the Company that it had completed its review of the Company's response to the issue cited in the FDA clinical hold letter and that the clinical hold had been lifted; therefore, the IMPACT-DCM clinical trial could resume. To date, nine of 40 patients have been enrolled in the IMPACT-DCM trial at the first three sites. Activation of the fifth clinical site is underway.
Aastrom Biosciences, Inc.' Phase II IMPACT-DCM Clinical Trial Placed On Clinical Hold Pending Review
Aastrom Biosciences, Inc. announced that one patient enrolled in the Company's U.S. Phase II IMPACT-DCM clinical trial experienced a serious adverse event associated with anesthesia management during treatment at one of the active clinical sites. According to the results of an internal review conducted at the clinical site, and a second review by the trial's independent Data Safety Monitoring Board (DSMB), this event has been attributed to anesthesia administration and management in this single patient. Furthermore, these two reviews separately determined that this event was not related to the surgical approach or the use of Aastrom's Cardiac Repair Cells (CRCs) in this procedure. This patient has received appropriate treatment, has fully recovered from this isolated event and continues to be monitored in accordance with the study protocol. In compliance with regulatory requirements and standard operating procedures, this event was reported directly to the U.S. Food and Drug Administration (FDA) and Aastrom immediately took the initiative to suspend patient enrollment at the clinical site where the event took place, pending an internal review and the implementation of a corrective action plan.
Aastrom Biosciences, Inc. Files $50 Million Mixed Securities Shelf-DJ
Dow Jones reported that Aastrom Biosciences, Inc. registered to sell up to $50 million of common stock, preferred stock, debt securities and/or warrants from time to time. No underwriters or trustees were listed in Wednesday's SEC filing.
Q+A: Skin cells transformed directly to nerve in study
WASHINGTON (Reuters) - Using just three genes, California researchers have transformed mouse skin cells directly into nerve cells called neurons.
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