| Commitments and Contingencies |
Note
6 - Commitments and Contingencies
License
and Research Agreements
The
Company has entered into license and research and development agreements with third parties under which the Company was obligated
to make upfront payments as well as milestone and royalty payments. Notable inclusions in this category are:
| a. |
AbbVie
Biotherapeutics Corp. - The Company entered into a Product Development and Patent License Agreement with AbbVie Biotherapeutics
Corp. in 2003 to secure exclusive rights to a specific antibody when conjugated with alpha emitting radioisotopes. Upon execution
of the agreement, the Company made a license fee payment of $3,000,000. |
The
Company agreed to make milestone payments totaling $7,750,000 for the achievement of certain contracted milestones.
Under
the agreement, the Company shall pay to AbbVie Biotherapeutics Corp. on a country-by-country basis a royalty of 12% of net sales
of all licensed products until the later of: (1) 12.5 years after the first commercial sale, or (2) when the patents expire.
The
Company met its first milestone in 2012 and upon reaching the milestone the Company paid AbbVie Biotherapeutics Corp. a milestone
payment of $750,000. The milestone payment for the Phase 1 Clinical Trial was recorded as research and development
expense. In September 2016, the Company met its second milestone and as of December 31, 2017, $750,000 was included in accounts
payable and accrued expenses on the balance sheet.
| b. |
MSKCC
- see Note 2 - Related Party Transactions. |
| c. |
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 January 9, 2017, the Company signed a contract
with ORNL to purchase $0.7 million of radioactive material. During the years ended December 31, 2017, 2016 and 2015, the Company
purchased material from ORNL of approximately $0.6 million, $1.0 million and $0.8 million, respectively. On December 13, 2017,
the Company signed a contract with ORNL to purchase $0.2 million of radioactive material during calendar year 2018. |
| d. |
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. Upon commercial sale of the drug, royalty payments of 2% of net sales will be due to FHCRC. For the years
ended December 31, 2017, 2016 and 2015, the Company incurred expenses of approximately $45,000, $0.4 million and $0.3 million,
respectively, related to this agreement. |
| e. |
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 to be used
in the Phase 3 clinical trial of Iomab-B. As of December 31, 2017, the remaining cost of the service agreement (only) is approximately
$1.8 million. For each of the years ended December 31, 2017, 2016 and 2015, the Company paid Goodwin approximately $1.4 million,
$0.7 million and $4.2 million, respectively. |
| |
|
| f. |
On February 16, 2016, the Company entered into an agreement with Medpace, Inc. (“Medpace”),
a Contract Research Organization. Medpace provides project management services for the Iomab-B study. The total project is
estimated to cost approximately $7.2 million. Medpace bills the Company when services are rendered and the Company records the
related expense to research and development costs. For the years ended December 31, 2017 and 2016, the Company paid Medpace approximately
$2.8 million and $2.6 million, respectively. |
| |
|
| g. |
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. For the years ended December 31, 2017 and 2016, the Company paid George approximately
$0.7 million and $0.1 million, respectively. |
Lease
Agreements
The Company does not
own any real property. It currently leases office space located at 275 Madison Avenue, 7th Floor, New York, NY 10016. The lease
expires September 6, 2022 with an annual rental rate of $312,660 per year through June 6, 2019 and an annual rate of $341,610 for
the remaining period. The Company is also responsible for certain other costs, such as insurance, taxes, utilities, and maintenance.
The Company issued a letter of credit of $390,825 in connection with the lease and maintains a $390,940 certified deposit as collateral
for the letter of credit.
On
June 8, 2017, the Company also entered into a license agreement for furniture and fixtures located at its office space. Pursuant
to the terms of the agreement, the Company leases the furniture, fixtures, equipment and tenant improvements located in the office
space for the same term as the office space for $7,529 per month. The Company shall have at any time during the term of this amended
agreement the right to purchase the furniture, fixtures and equipment.
Future
minimum obligations on all of the Company’s leases are:
| For the year ending December 31: |
|
|
|
| 2018 |
|
$ |
403,008 |
|
| 2019 |
|
|
419,896 |
|
| 2020 |
|
|
431,958 |
|
| 2021 |
|
|
431,958 |
|
| Thereafter |
|
|
287,972 |
|
| Total |
|
$ |
1,974,792 |
|
|