Aastrom Biosciences | ||
Dominos Farms, Lobby K | ||
24 Frank Lloyd Wright Drive | ||
Ann Arbor, MI 48105 | ||
T 734 9305555 F 734 6650485 | ||
www.aastrom.com |
Re: | Aastrom Biosciences, Inc. Form 10-K for the Year Ended June 30, 2010 Form 10-K/A for the Year Ended June 30, 2010 File No. 000-22025 |
1. | We note your response to our prior comment 2. Please be more specific in your explanation regarding your third-party agreements. In particular, please describe the components and materials you obtain through each of these agreements and why you believe that you would only experience a minor disruption if any of the agreements were amended or terminated. | |
Response 1: | ||
In response to the Staffs comment, the Company supplements its response to the Staffs prior comment 2 regarding its third-party arrangements. The Company respectfully advises the Staff that the Company is not substantially dependent on its relationships with |
Sparton Corporation (Sparton), Lonza Walkersville, Inc. (Lonza), Life Technologies Corporation (Life Technologies) (formerly Invitrogen), BioLife Solutions, Inc. (BioLife), Ethox International (Ethox), or Genpore as discussed below. |
Sparton | ||
Pursuant to the Master Supply Agreement between the Company and Sparton effective as of February 14, 2003, Sparton manufactured the Companys Aastrom Replicell System units (the ARS units), a platform used to produce various cell mixtures. Based upon the Companys current business strategy, ARS is no longer being marketed as a stand-alone product, and the Company has not purchased ARS units from Sparton (or others) in more than five years. If it were to produce ARS units in the future, the Company anticipates that it could find an alternative manufacturer because the Company owns and maintains the plans and molds necessary to manufacture the ARS units. | ||
Lonza | ||
Lonza currently supplies media for the Companys manufacturing process and bone marrow for the Companys non-clinical research and development activities. Alternative sources exist for both the media and bone marrow and the Company believes it could secure a supplier for these materials relatively quickly and for little or no additional cost to the Company. | ||
Life Technologies | ||
Life Technologies currently supplies the Companys reagents and serum for use in the Companys manufacturing process, either of which could be supplied by an alternative third party relatively quickly and at little or no additional cost to the Company. | ||
BioLife | ||
BioLife supplies the Company with HypoThermosol, a biopreservation media product used to extend the shelf life of the Companys cell therapy product from twenty-four to seventy-two hours. This extension of the shelf life allows for longer logistical lead times, though it is not a critical requirement as the Company could continue to treat patients in its clinical trials even if its cell therapy product had a twenty-four hour shelf life. In addition, the Company believes that a method for extending the shelf life of its cell therapy product could be fully developed relatively quickly, either by developing internally or by seeking alternative suppliers, thereby providing only a minor disruption to the Company in the event HypoThermosol is not available. | ||
Ethox | ||
Ethox formerly supplied a component of the cell cassette. The Company is in the process of identifying a new supplier which will supply the component directly to ATEK Medical, LLC (ATEK) and will not have a direct supply relationship with the Company. | ||
Genpore | ||
Genpore supplies a component of the cell cassettes to ATEK and no longer has a direct supply relationship with the Company. |
For the reasons outlined above, the Company believes that it would only experience a minor disruption if any of the arrangements described above were amended or terminated. |
2. | We acknowledge your response to our previous comment five and your disclosure describing your restatement in Note 2. Please provide us proposed revised disclosure for this footnote to be included in your future periodic reports that identifies the instruments that could potentially be net cash settled in the absence of express language precluding such settlement and those that have anti-dilution price protection features. Separately describe the types of events that would trigger the exercise price adjustments and how the price adjustments will be calculated. | |
Response 2: | ||
In response to the Staffs comment, we advise the Staff that the Company will revise its disclosure in future filings, including in its Transition Report on Form 10-K for the six month period ended December 31, 2010, to the extent applicable, to read as set forth in Exhibit A hereto. | ||
3. | Please explain to us why you include your January 2010 Class B warrants as liabilities in your restated financial statements. In this regard, please help us understand how the apparent preclusion of settlement for cash or other consideration in the event you are unable to deliver Warrant Shares as stipulated in Section 3.3(a) of your Class B warrant agreement filed as Exhibit 4.2 to your Form 8-K filed on January 27, 2010 and the apparent absence of an anti-dilution price protection provision is indicative of liability treatment. In your response, please clarify for us whether there are any other provisions in the Class B warrant that necessitate liability treatment and reference for us the authoritative literature you rely upon to support your accounting. | |
Response 3: | ||
In response to the Staffs comment, the Company reviewed the accounting of its Class B warrants issued in connection with its January 21, 2010 offering and determined that these Class B warrants should not be reflected as liabilities in its financial statements. The Company has concluded that its accounting for the Class B warrants as liability instruments, which expired in early July 2010, did not materially impact its previously-filed financial statements or the financial statements for the three and six month periods ended December 31, 2010, and therefore will correct this as an out-of-period adjustment in its Transition Report on Form 10-K for the six month period ended December 31, 2010. In making this materiality assessment, the Company also considered the matter raised by the Staff in Comment 4 below. The Company will add disclosure in its Transition Report on Form |
10-K for the six month period ended December 31, 2010 to read as set forth in Exhibit B hereto. | ||
4. | We do not believe that a Black-Scholes valuation model appropriately captures the value of warrants that include anti-dilution price protection provisions. In this regard the Black-Scholes model is a single path model that does not take into account the potential exercise price adjustments under your warrants anti-dilution price protection provisions. Please use an appropriate valuation model such as a binomial or lattice model. | |
Response 4: | ||
The Company advises the Staff that, beginning on December 31, 2010, it will use a Monte Carlo valuation model to value its warrants that include anti-dilution price protection provisions. As of June 30, 2010 the Class A warrants issued on January 21, 2010 were the only outstanding warrants of the Company with anti-dilution price protection provisions. The Company has concluded that the impact of using a Black-Scholes valuation methodology for the Class A warrants to previously-filed financial statements, or to the three and six month periods ended December 31, 2010, was not material and, therefore, will correct this as an out-of-period adjustment in its Transition Report on Form 10-K for the six month period ended December 31, 2010. In making this materiality assessment, the Company also considered the matter raised by the Staff in Comment 3 above. The Company will add disclosure in its Transition Report on Form 10-K for the six month period ended December 31, 2010 to read as set forth in Exhibit B hereto. |
cc: | Timothy Mayleben, Aastrom Biosciences, Inc. Mitchell S. Bloom, Esq., Goodwin Procter LLP Danielle Lauzon, Esq., Goodwin Procter LLP Jacqueline Mercier, Esq., Goodwin Procter LLP Jeff Riedler, U.S. Securities and Exchange Commission Mark Brunhofer, U.S. Securities and Exchange Commission Kei Nakada, U.S. Securities and Exchange Commission Scot Foley, U.S. Securities and Exchange Commission |
(i) | warrants to purchase an aggregate of 300,000 shares of the Companys common stock, issued on April 5, 2004 in connection with the Companys registered direct offering, exercisable for a five year period commencing on April 5, 2004 at an exercise price of $13.20 per share, all of which expired unexercised; | ||
(ii) | warrants to purchase an aggregate of 320,248 shares of the Companys common stock, issued on October 27, 2004 in connection with the Companys registered direct offering, exercisable from April 28, 2005 through October 27, 2008 at an exercise price of $13.92 per share, all of which expired unexercised; | ||
(iii) | warrants to purchase an aggregate of 740,131 shares of the Companys common stock, issued on October 17, 2007 in connection with the Companys registered direct offering, exercisable from April 18, 2008 through April 17, 2013 at an exercise price of $12.72 per share, all of which remained outstanding as of December 31, 2010; | ||
(iv) | Class A warrants to purchase an aggregate of 4,882,228 shares of the Companys common stock, issued on January 21, 2010 in connection with the Companys registered public offering, exercisable for a five year period commencing on July 21, 2010 at an exercise price of $2.52 per share (as adjusted from $2.97 per share for the anti-dilution provision triggered in the December 2010 financing), 4,525,978 of which remained outstanding as of December 31, 2010; and | ||
(v) | warrants to purchase an aggregate of 10,000,000 shares of the Companys common stock, issued on December 15, 2010 in connection with the Companys registered public offering, exercisable for a five year period commencing on December 15, 2010 at an exercise price of $3.22 per share, all of which remained outstanding as of December 31, 2010. |