Quarterly report pursuant to Section 13 or 15(d)

Commitments and Contingencies

Commitments and Contingencies
9 Months Ended
Sep. 30, 2019
Commitments and Contingencies Disclosure [Abstract]  
Commitments and Contingencies

Note 2 - Commitments and Contingencies




The Company has entered into agreements with third parties for the rights to certain intellectual property, manufacturing and clinical trial services under which the Company may incur obligations to make payments including upfront payments as well as milestone and royalty payments. Notable inclusions in this category are: 


  a. Oak Ridge National Laboratory ("ORNL") – The Company is contracted to purchase radioactive material to be used for research and development, with a renewal option at the contract end. On December 19, 2018, the Company signed a contract with ORNL to purchase $0.2 million of radioactive material during calendar year 2019. During the nine months ended September 30, 2019 and 2018, the Company purchased material from ORNL of approximately $0.2 million in each period.


  b. On June 15, 2012, the Company entered into a license and sponsored research agreement with Fred Hutchinson Cancer Research Center ("FHCRC") to build upon previous and ongoing clinical trials, with BC8 (licensed antibody). FHCRC has currently completed both a Phase 1 and Phase 2 clinical trial with BC8. The Company has been granted exclusive rights to the BC8 antibody and related master cell bank developed by FHCRC. A milestone payment of $1 million will be due to FHCRC upon FDA approval of the first drug utilizing the licensed BC 8 antibody. Upon commercial sale of the drug, royalty payments of 2% of net sales will be due to FHCRC.


  c. On February 27, 2014, the Company entered into a manufacturing agreement with Goodwin Biotechnology Inc. ("Goodwin"). Goodwin oversees the current Good Manufacturing Practices ("cGMP") production of a monoclonal antibody used in the Phase 3 clinical trial of Iomab-B. As of September 30, 2019, the remaining cost of the service agreement is $0.3 million. For the nine months ended September 30, 2019 and 2018, the Company paid Goodwin $1.5 million and $1.0 million, respectively.


  d. On February 16, 2016, the Company entered into an agreement with Medpace, Inc. ("Medpace"), a Contract Research Organization, ("CRO"). Medpace provides project management services for the Iomab-B study. The total project is currently estimated to cost approximately $10.2 million. As of September 30, 2019, the remaining cost of the agreement is approximately $0.9 million. Medpace bills the Company when services are rendered and the Company records the related expense to research and development costs. During the nine months ended September 30, 2019 and 2018, the Company paid Medpace $2.0 million and $2.6 million, respectively.  These payments are for Medpace project management services and pass-through expenses incurred by investigators and clinical sites.


Collaborative Agreement


In March 2018, the Company entered into a research and option agreement with Astellas Pharma Inc. ("Astellas") to develop ARC's using the Company's AWE Technology Platform. Under this collaboration, the Company will utilize its AWE Platform to conjugate and label selected Astellas targeting agents with an Actinium-225 payload. The Company will also be responsible for conducting preclinical validation studies on any ARCs generated. Payments from Astellas under this agreement are accounted for as a reduction to research and development expense.