Note 7 - Commitments and Contingencies	9 Months Ended
Sep. 30, 2019
Notes to Financial Statements
Commitments and Contingencies Disclosure [Text Block]	Note 7—Commitments and Contingencies Leases On April 16, 2018, the Company executed a service agreement with CIC Innovation Communities, LLC, to establish and lease offices at the Cambridge Innovation Center at 1 Broadway, Floor 14, Cambridge, MA 02142. The Company does not have a long-term agreement in place to occupy this location, but rather occupies on a month-to-month basis. On April 16, 2018, the Company also executed a space utilization agreement with the Board of Regents of the University of Texas System to establish and lease offices at the Dell Medical School located 1601 Trinity Street, Building B, Suite 3.322, Austin, Texas 78712. The Company pays $2,050 per month to occupy this location and the lease is effective until October 31, 2019. Commitments MD Anderson We have entered into and amended a clinical trial agreement with the MD Anderson to administer a Phase I/II clinical trial, combining TUSC2 nanoparticles and erlotinib in Stage IV lung cancer patients. The trial is expected to run through early 2023 with a projected total cost of approximately $2 million. Payments are due and payable when invoiced throughout the clinical trial period. The agreement may be terminated at any time. In July 2018, the Company announced the execution of a two -year sponsored research agreement with MD Anderson. The Company is sponsoring pre-clinical studies focused on the combination of TUSC2 with immunotherapies and have a projected total cost of approximately $2 million. The agreement may be terminated at any time. In July 2018, we renewed an option agreement with MD Anderson that granted us exclusive rights to negotiate, until March 13, 2019, an exclusive license to the use of TUSC2, the active agent in Oncoprex, in combination with immunotherapies. On March 12, 2019, and again on June 13, 2019, we and MD Anderson extended the term of this option, most recently until December 31, 2019. In July 2018, we renewed an option agreement with MD Anderson that granted us exclusive rights to negotiate, until March 13, 2019, an exclusive license to the use of TUSC2 in combination with epidermal growth factor receptor, or EGFR, therapies and the development of biomarkers to predict patient response to TUSC2 therapy. We are working with MD Anderson to extend the term of this option agreement. National Institutes of Health In 2009, we agreed to assume certain contractual and other obligations of IRI in consideration for the sublicense rights, expertise, and assistance associated with the assignment of certain technologies and intellectual property. We also agreed to pay royalties of one percent ( 1% ) on sales of resulting Licensed Products, for a period of 21 years following the termination of the last of the MD Anderson License Agreement and Sublicense Agreement, to IRI and we assumed patent prosecution costs and an annual minimum royalty of $20,000 payable to the National Institutes of Health (“NIH”). Our $191,393 payment obligation to the NIH represented a current obligation, of which $15,393 of 2016 patent prosecution costs were paid in the fourth quarter of 2016 and $176,000 was included in Accounts Payable at December 31, 2016 ( consisting of accrued annual royalties of $140,000 and patent costs of $36,000 ). During the first quarter of 2017, we modified the terms of our accrued royalty obligation to NIH. Under the modified agreement, NIH agreed to extinguish $120,000 of the accrued royalties payable to them in consideration for payment by us of (i) accrued patent costs of $36,000, (ii) a royalty payment of $20,000, and (iii) a contingent payment of $240,000, increasing at $20,000 per year starting in 2018, to be paid upon our receipt of FDA approval. The payments for the patent costs of $36,000 and royalties of $20,000 were paid during the second quarter of 2017. As a result of our modified agreement with the NIH, we have recognized the exchange of the $120,000 fixed obligation for the $240,000 contingent obligation as a $120,000 reduction to intellectual property expense (classified within General and Administrative Expense) during the first quarter of 2017. The $240,000 contingent obligation (and related expense) will be recognized when we obtain regulatory approval (the event that triggers the payment obligation). Contingencies From time to time we may become subject to threatened and/or asserted claims arising in the ordinary course of our business. Management is not aware of any matters, either individually or in the aggregate, that are reasonably likely to have a material impact on our Company’s financial condition, results of operations or liquidity. During October 2017, we received an informal demand from a former financial advisor, claiming that it is entitled to a warrant to purchase shares of common stock equal to three percent ( 3% ) of our outstanding shares at December 1, 2015. We believe this asserted claim lacks merit, and we intend to defend the claim vigorously.

Note

7—Commitments

and Contingencies

Leases

April 16, 2018,

the Company executed a service agreement with CIC Innovation Communities, LLC, to establish and lease offices at the Cambridge Innovation Center at

Broadway, Floor

14,

Cambridge, MA

02142.

The Company does

not

have a long-term agreement in place to occupy this location, but rather occupies on a month-to-month basis.

April 16, 2018,

the Company also executed a space utilization agreement with the Board of Regents of the University of Texas System to establish and lease offices at the Dell Medical School located

1601

Trinity Street, Building B, Suite

3.322,

Austin, Texas

78712.

The Company pays

$2,050

per month to occupy this location and the lease is effective until

October

31,

2019.

Commitments

MD Anderson

We have entered into and amended a clinical trial agreement with the MD Anderson to administer a Phase I/II clinical trial, combining

TUSC2

nanoparticles and erlotinib in Stage IV lung cancer patients. The trial is expected to run through early

2023

with a projected total cost of approximately

million. Payments are due and payable when invoiced throughout the clinical trial period. The agreement

may

be terminated at any time.

July 2018,

the Company announced the execution of a

two

-year sponsored research agreement with MD Anderson. The Company is sponsoring pre-clinical studies focused on the combination of

TUSC2

with immunotherapies and have a projected total cost of approximately

million. The agreement

may

be terminated at any time.

July 2018,

we renewed an option agreement with MD Anderson that granted us exclusive rights to negotiate, until

March 13, 2019,

an exclusive license to the use of

TUSC2,

the active agent in Oncoprex, in combination with immunotherapies. On

March 12, 2019,

and again on

June 13, 2019,

we and MD Anderson extended the term of this option, most recently until

December 31, 2019.

July 2018,

we renewed an option agreement with MD Anderson that granted us exclusive rights to negotiate, until

March 13, 2019,

an exclusive license to the use of

TUSC2

in combination with epidermal growth factor receptor, or EGFR, therapies and the development of biomarkers to predict patient response to

TUSC2

therapy. We are working with MD Anderson to extend the term of this option agreement.

National Institutes of Health

2009,

we agreed to assume certain contractual and other obligations of IRI in consideration for the sublicense rights, expertise, and assistance associated with the assignment of certain technologies and intellectual property. We also agreed to pay royalties of

one

percent (

) on sales of resulting Licensed Products, for a period of

years following the termination of the last of the MD Anderson License Agreement and Sublicense Agreement, to IRI and we assumed patent prosecution costs and an annual minimum royalty of

$20,000

payable to the National Institutes of Health (“NIH”).

Our

$191,393

payment obligation to the NIH represented a current obligation, of which

$15,393

2016

patent prosecution costs were paid in the

fourth

quarter of

2016

and

$176,000

was included in Accounts Payable at

December 31, 2016 (

consisting of accrued annual royalties of

$140,000

and patent costs of

$36,000

). During the

first

quarter of

2017,

we modified the terms of our accrued royalty obligation to NIH. Under the modified agreement, NIH agreed to extinguish

$120,000

of the accrued royalties payable to them in consideration for payment by us of (i) accrued patent costs of

$36,000,

(ii) a royalty payment of

$20,000,

and (iii) a contingent payment of

$240,000,

increasing at

$20,000

per year starting in

2018,

to be paid upon our receipt of FDA approval. The payments for the patent costs of

$36,000

and royalties of

$20,000

were paid during the

second

quarter of

2017.

As a result of our modified agreement with the NIH, we have recognized the exchange of the

$120,000

fixed obligation for the

$240,000

contingent obligation as a

$120,000

reduction to intellectual property expense (classified within General and Administrative Expense) during the

first

quarter of

2017.

The

$240,000

contingent obligation (and related expense) will be recognized when we obtain regulatory approval (the event that triggers the payment obligation).

Contingencies

From time to time we

may

become subject to threatened and/or asserted claims arising in the ordinary course of our business. Management is

not

aware of any matters, either individually or in the aggregate, that are reasonably likely to have a material impact on our Company’s financial condition, results of operations or liquidity.

During

October 2017,

we received an informal demand from a former financial advisor, claiming that it is entitled to a warrant to purchase shares of common stock equal to

three

percent (

) of our outstanding shares at

December 1, 2015.

We believe this asserted claim lacks merit, and we intend to defend the claim vigorously.