By Brady Huggett
Aastrom Biosciences Inc., nearing its goal of generating product revenues, completed a public offering worth about $11 million and will apply the money toward, in part, a European sales team.
¿The funds will be used to build up our European sales and marketing activities for our lead cell therapy products and to build our dendritic cell vaccine and bone regeneration programs,¿ Douglas Armstrong, president and CEO of Aastrom, told BioWorld Today. ¿It has given us the funding we need to fill our operational plan for the coming year.¿
Ann Arbor, Mich.-based Aastrom sold 7.7 million common shares made available for sale through a shelf registration. Shares were sold at between 82 cents and $1.78 over a period of about three months.
¿We pulled it down in several pieces with three different investors,¿ Armstrong said. ¿And we found it to be an effective way to address our capital needs.¿
Aastrom¿s stock (NASDAQ:ASTM) rose 3 cents Thursday to close at 99 cents. The company reported having about $10.7 million in cash and investments on June 30. Armstrong said Aastrom burned through about $650,000 a month during the past year. Its weighted average of shares outstanding for the quarter was about 34.8 million.
For the quarter ended June 30, Aastrom reported a net loss of about $1.9 million, or 5 cents per share. It received $246,000 in total revenue for the period, none of which was the result of product sales. But that is going to change, Armstrong said.
¿We have two products that are in Phase III in the U.S. and have received CE Mark approval in Europe,¿ Armstrong said. ¿We are projecting our first product revenue over the next 12 months.¿
The products approved in Europe and in U.S. Phase III trials are the CB-I Therapy Kit (cord blood), which is designed to treat leukemia and genetic blood diseases, and the SC-I (bone marrow stem cells) Therapy Kit, which is for solid tumors. The company also has received the CE Mark on its instrumentation platform, AastromReplicell.
¿We have announced that we intend to have our first dendritic cell vaccine product [DC-I Therapy Kit] ready for commercialization in Europe in the fourth quarter of this year,¿ Armstrong said. ¿We also started a U.S. clinical trial, Phase I/II for OC-I, a bone cell product, for patients with osteoporosis. It¿s progressing well, well enough so that we expect additional trials over the next 12 months.¿
Aastrom is able to manufacture specific cell mixtures that can be used as therapies in lieu of drugs through its AastromReplicell System Instrumentation Platform.
¿The Replicell gives us the capability to manufacture individual batches of cells for patients,¿ Armstrong said. ¿It¿s very efficient. It takes eight to 12 days and each batch is done automatically. You don¿t have cell culture technicians or hoods, people trying to grow and produce cells. It eliminates that need.¿
Working toward European launches, Aastrom recently established a subsidiary ¿ Zellera AG ¿ in Berlin, for marketing, sales and product support. The light at the end of the tunnel for Aastrom is the glimmer of product sales.
¿We find ourselves positioned with enormous opportunities now,¿ Armstrong said. ¿[We¿re ready] to sell products in Europe and our new programs are exciting opportunities. We now have the funding we needed to move forward. Instead of being able to talk about [plans], we can now implement them. This is a big year for us.¿