Note 6 - Commitments and Contingencies	3 Months Ended
Mar. 31, 2021
Notes to Financial Statements
Commitments and Contingencies Disclosure [Text Block]	Note 6 - 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 in Cambridge, Massachusetts. On April 1, 2020, the Company provided notice of cancellation of our lease in the Cambridge Innovation Center in Cambridge, Massachusetts, effective as of April 30, 2020. On April 16, 2018, the Company 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 in Austin, Texas. On March 23, 2021, the Company was informed by Dell Medical School that the University of Texas desired to use the space and not renew the space utilization agreement. The lease terminates on April 30, 2021 and the Company pays $462 per month to occupy this location. See Note 8 - Subsequent Events. Commitments MD Anderson Cancer Center The Company entered into a clinical study agreement with the MD Anderson, to administer the Company's phase 1/2 clinical trial, combining REQORSA-nanoparticles and Tarceva in Stage 4 lung cancer patients. The trial was expected to run through the end of 2018 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 2020, the Company received Fast Track Designation ("FTD") from the FDA for its Acclaim- 1 trial which combines REQORSA plus Tagrisso in patients who have previously failed Tagrisso treatment. Given the FTD and with Tagrisso now considered a new standard of care in the U.S. for NSCLC with an epidermal growth factor receptor ("EGFR") mutation, the Company is no longer enrolling ONC- 002 and plan to initiate Acclaim- 1 and Acclaim- 2 in 2021. In July 2018, the Company entered into a two -year sponsored research agreement with MD Anderson to sponsor preclinical studies focused on the combination of REQORSA with an immunotherapy 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. This agreement has been extended through May 2022. In 2011, the Company agreed to assume certain contractual and other obligations of IRI in consideration for the sublicense rights, expertise, and assistance associated with certain technologies and intellectual property originally licensed to another party under a 1994 License Agreement with MD Anderson (“Original MD Anderson License Agreement”). These technologies and intellectual property were later sublicensed to IRI (the “IRI Sublicense”). The Company also agreed to pay royalties of 1% on sales of certain licensed products for a period of 21 years following the termination of the later of the Original MD Anderson License Agreement and the IRI Sublicense. The Company assumed patent prosecution costs and an annual minimum royalty of $20,000 payable to the National Institutes of Health. On March 3, 2021, the Company entered into an amendment (the “MD License Amendment”) to the Patent and Technology License Agreement dated May 4, 2020 with MD Anderson. The MD License Amendment grants the Company a worldwide, exclusive, sublicensable license to an additional portfolio of six patents and one patent application and related technology for methods for treating cancer by administration of a TUSC2 therapy in conjunction with EGFR inhibitors or other anti-cancer therapies in patients predicted to be responsive to TUSC2 therapy. Pursuant to the MD License Amendment, the Company agreed to (i) pay annual maintenance fees ranging from the mid five figures to the low six figures, (ii) total milestone payments of $6,150,000, (iii) a one -time fee in the mid five figures and (iv) certain patent related expenses. National Institutes of Health Our $191,393 payment obligation to the National Institutes of Health (“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 it in consideration of 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 by $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, which increases annually by $20,000 and is $300,000 as of December 31, 2020, will be recognized when we obtain regulatory approval (the event that triggers the payment obligation). University of Pittsburgh Pursuant to the Exclusive License Agreement dated February 11, 2020 by and between the Company and the University of Pittsburgh, the Company agreed to pay (i) an initial licensing fee of $25,000, (ii) annual maintenance fees of $25,000 for the first three years and $40,000 for each subsequent year following the first anniversary of the agreement, (iii) royalties ranging from 1.5% to 3% of net sales of licensed technologies, (iv) an annual minimal royalty payment of $250,000 per year beginning in the year of the first commercial sale of licensed technology, (v) a share of non-royalty sublicense income of 20%, and (vi) an aggregate of of $3,975,000 in milestone payments. Unless earlier terminated pursuant to its terms, the agreement expires upon the later of (i) 20 years after the first commercial sale of the licensed technology thereunder and (ii) expiration of the last valid claim under the patent rights. 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 financial condition, results of operations or liquidity.

Note

- 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 in Cambridge, Massachusetts. On

April 1, 2020,

the Company provided notice of cancellation of our lease in the Cambridge Innovation Center in Cambridge, Massachusetts, effective as of

April 30, 2020.

April 16, 2018,

the Company 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 in Austin, Texas. On

March 23, 2021,

the Company was informed by Dell Medical School that the University of Texas desired to use the space and

not

renew the space utilization agreement. The lease terminates on

April 30, 2021

and the Company pays

$462

per month to occupy this location. See Note

- Subsequent Events.

Commitments

MD Anderson Cancer Center

The Company entered into a clinical study agreement with the MD Anderson, to administer the Company's phase

1/2

clinical trial, combining REQORSA-nanoparticles and Tarceva in Stage

lung cancer patients. The trial was expected to run through the end of

2018

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. In

2020,

the Company received Fast Track Designation ("FTD") from the FDA for its Acclaim-

trial which combines REQORSA plus Tagrisso in patients who have previously failed Tagrisso treatment. Given the FTD and with Tagrisso now considered a new standard of care in the U.S. for NSCLC with an epidermal growth factor receptor ("EGFR") mutation, the Company is

longer enrolling ONC-

002

and plan to initiate Acclaim-

and Acclaim-

2021.

July 2018,

the Company entered into a

two

-year sponsored research agreement with MD Anderson to sponsor preclinical studies focused on the combination of REQORSA with an immunotherapy 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. This agreement has been extended through

May 2022.

2011,

the Company agreed to assume certain contractual and other obligations of IRI in consideration for the sublicense rights, expertise, and assistance associated with certain technologies and intellectual property originally licensed to another party under a

1994

License Agreement with MD Anderson (“Original MD Anderson License Agreement”). These technologies and intellectual property were later sublicensed to IRI (the “IRI Sublicense”). The Company also agreed to pay royalties of

on sales of certain licensed products for a period of

years following the termination of the later of the Original MD Anderson License Agreement and the IRI Sublicense. The Company assumed patent prosecution costs and an annual minimum royalty of

$20,000

payable to the National Institutes of Health.

March 3, 2021,

the Company entered into an amendment (the “MD License Amendment”) to the Patent and Technology License Agreement dated

May 4, 2020

with MD Anderson. The MD License Amendment grants the Company a worldwide, exclusive, sublicensable license to an additional portfolio of

six

patents and

one

patent application and related technology for methods for treating cancer by administration of a

TUSC2

therapy in conjunction with EGFR inhibitors or other anti-cancer therapies in patients predicted to be responsive to

TUSC2

therapy. Pursuant to the MD License Amendment, the Company agreed to (i) pay annual maintenance fees ranging from the mid

five

figures to the low

six

figures, (ii) total milestone payments of

$6,150,000,

(iii) a

one

-time fee in the mid

five

figures and (iv) certain patent related expenses.

National Institutes of Health

Our

$191,393

payment obligation to the National Institutes of Health (“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 it in consideration of 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 by

$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, which increases annually by

$20,000

and is

$300,000

as of

December 31, 2020,

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

University of Pittsburgh

Pursuant to the Exclusive License Agreement dated

February 11, 2020

by and between the Company and the University of Pittsburgh, the Company agreed to pay (i) an initial licensing fee of

$25,000,

(ii) annual maintenance fees of

$25,000

for the

first

three

years and

$40,000

for each subsequent year following the

first

anniversary of the agreement, (iii) royalties ranging from

1.5%

of net sales of licensed technologies, (iv) an annual minimal royalty payment of

$250,000

per year beginning in the year of the

first

commercial sale of licensed technology, (v) a share of non-royalty sublicense income of

20%,

and (vi) an aggregate of of

$3,975,000

in milestone payments. Unless earlier terminated pursuant to its terms, the agreement expires upon the later of (i)

years after the

first

commercial sale of the licensed technology thereunder and (ii) expiration of the last valid claim under the patent rights.

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 financial condition, results of operations or liquidity.