On January 12, 2009, Micromet announced the execution of an option, collaboration and license agreement with Bayer Schering Pharma AG. Under the terms of this agreement, Micromet granted Bayer Schering Pharma an exclusive option until January 2010 to obtain the rights to develop and commercialize a specific BiTE antibody against an undisclosed solid tumor target. Bayer Schering Pharma paid an option fee of around $6.0 million and may exercise the option with the payment of an additional option exercise fee, which would trigger a formal collaboration to develop this BiTE antibody. Micromet would be eligible to receive from Bayer Schering Pharma around EUR290 million in total, including the option exercise fee and potential milestone payments, and up to a double-digit royalty based on tiered net sales of the product. In addition, Micromet would be reimbursed for development expenses incurred in this collaboration.
On January 13, 2009, the company together with the Ludwig-Maximilian-University in Munich, Germany published data in the peer reviewed journal Nature Cell Biology revealing a novel signaling function of the epithelial cell adhesion molecule, or EpCAM, which is expressed at high frequency on many tumor types. The data indicate that only cancer cells have an active signaling form of EpCAM that promotes tumor formation. This data further supports the scientific and clinical rationale behind two of Micromet’s most advanced clinical product candidates, adecatumumab and MT110, both of which target EpCAM.
On February 23, 2009, the company announced the addition of Kapil Dhingra, M.D. to the board of directors. Dhingra has been active in oncology clinical research for over 20 years, most recently as head of Oncology Development at Hoffman La-Roche, where he built the largest oncology clinical development department in the industry. Dr. Dhingra brings deep oncology development experience and perspective to Micromet’s Board of Directors.
On March 12, 2009, Micromet announced that it had regained North American rights to its most advanced product candidate, blinatumomab (MT103), from MedImmune. Micromet is responsible for the further clinical development and commercialization of blinatumomab. MedImmune is obligated to complete the development of the commercial scale manufacturing process for blinatumomab at its cost. Upon the first marketing approval of blinatumomab in the US, MedImmune will have a one-time option to reacquire the commercialization rights in North America at pre-defined terms.
On March 23, 2009, Micromet announced the initiation of a new phase 2 clinical trial with its human anti-EpCAM IgG1 antibody adecatumumab (MT201). This randomized, controlled phase 2 trial will evaluate adecatumumab in the treatment of patients with colorectal cancer after complete resection of liver metastases.
On April 2, 2009, Micromet announced the filing of a clinical trial application in Europe by its partner Nycomed for the anti-GM-CSF antibody MT203. The filing triggered a milestone payment to Micromet of around $2.0 million.
‘We are very pleased with the accomplishments during the first quarter of 2009, and we look forward to presenting clinical data at the American Society of Clinical Oncology meeting and the European Hematology Society meeting in the second quarter,’ stated Christian Itin, president and CEO of Micromet.
Total operating expenses were $12.4 million for the three months ended March 31, 2009, compared to $13.3 million for the same period in 2008.
Loss from operations for the three months ended March 31, 2009 was $4.9 million, compared to a loss from operations of $7.3 million for the same period in 2008.
The net loss for the three months ending March 31, 2009 includes a non-cash gain of $4.4 million, reflecting a decrease during the quarter in the fair value of warrants issued in connection with a private placement transaction in 2007. The company recorded a $1.3 million non-cash gain for this item in the first quarter of 2008.
Net cash provided by operating activities was $1.1 million for the three months ended March 31, 2009 compared to $0.4 million provided by operating activities for the same period in 2008. Micromet’s cash, cash equivalents and investments were $47.1 million as of March 31, 2009. Based on the current operating projections, the company believes the cash and cash equivalents as of March 31, 2009 will be sufficient to fund operations into the second half of 2010.
