Commitments and Contingencies |
Note
3 - Commitments and Contingencies
Agreements
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 13, 2017, the Company signed a contract with ORNL
to purchase $0.2 million of radioactive material during calendar year 2018. During the nine months ended September 30, 2018
and 2017, the Company purchased material from ORNL of approximately $0.2 million and $0.5 million, respectively. |
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. During the nine months ended September 30, 2018 and 2017, the Company
incurred expenses of $15,000 and $45,000, respectively, related to this agreement. |
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, 2018, the remaining cost of the service agreement is approximately $1.6 million.
During the nine months ended September 30, 2018 and 2017, the Company paid Goodwin $1.0 million and $1.1 million, respectively. |
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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, 2018, the remaining cost of the
agreement is approximately $3.7 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, 2018 and 2017, the
Company paid Medpace $2.6 million and $2.7 million, respectively. |
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e. |
On
August 4, 2016, the Company entered into a CRO agreement with George Clinical Services, (“George”). George
provides project management services for the study of Actimab-A used for a Phase 2 clinical trial. The total
project is estimated to cost approximately $4.6 million. As of September 30, 2018, the remaining cost of
the agreement is approximately $0.9 million. George 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, 2018 and 2017, the
Company paid George $1.6 million and $0.7 million, respectively. |
Collaborative
Agreement
In
March 2018, the Company entered into a research and option agreement with Astellas Pharma Inc. (“Astellas”) to develop
ARCs using the Company’s AWE Platform Technology. 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.
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