gnpx20190331b

UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

Washington, D.C. 20549

FORM 10-Q

(Mark One)

☒	QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934

For the quarterly period ended March 31, 2020

☐	TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934

For the transition period from __________________ to ______________

Commission file number: 001-38244

GENPREX, INC.

(Exact name of registrant as specified in its charter)

Delaware	90 - 0772347
(State or other jurisdiction of	(I.R.S. Employer
incorporation or organization)	Identification No.)

1601 Trinity Street, Bldg. B, Suite 3.322, Austin, TX	78712
(Address of principal executive offices)	(Zip Code)

(512) 537-7997

Registrant’s telephone number, including area code

Securities registered pursuant to Section 12(b) of the Act:

Title of each class

Trading

Symbol(s)

Name of each exchange on which registered

Common Stock, par value $0.001 per share

GNPX

The Nasdaq Capital Market

Indicate by check mark whether the registrant (1) has filed all reports required to be filed by Section 13 or 15(d) of the Securities Exchange Act of 1934 during the preceding 12 months (or for such shorter period that the registrant was required to file such reports), and (2) has been subject to such filing requirements for the past 90 days. Yes ☒ No ☐

Indicate by check mark whether the registrant has submitted electronically, every Interactive Data File required to be submitted pursuant to Rule 405 of Regulation S-T during the preceding 12 months (or for such shorter period that the registrant was required to submit such files). Yes ☒ No ☐

Indicate by check mark whether the registrant is a large accelerated filer, an accelerated filer, a non-accelerated filer, a smaller reporting company, or an emerging growth company. See definitions of “large accelerated filer,” “accelerated filer,” “smaller reporting company,” and “emerging growth company” in Rule 12b-2 of the Exchange Act.

Large accelerated filer	☐	Accelerated filer	☐
Non-accelerated filer	☒	Smaller reporting company	☒
		Emerging growth company	☒

If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. ☒

Indicate by check mark whether the registrant is a shell company (as defined in Rule 12b-2 of the Exchange Act). Yes ☐ No ☒

As of May 11, 2019, the registrant had 32,854,841 shares of common stock, par value $0.001 per share, outstanding.

GENPREX, INC.

TABLE OF CONTENTS

			Page No.

PART I	FINANCIAL INFORMATION		4

ITEM 1.	FINANCIAL STATEMENTS		4
	Condensed Balance Sheets as of March 31, 2020 (unaudited) and December 31, 2019		4
	Condensed Statements of Operations for the Three Months Ended March 31, 2020 and 2019 (unaudited)		5
	Condensed Statements of Changes in Stockholders' Equity for the Three Months Ended March 31, 2020 and 2019 (unaudited)		6
	Condensed Statements of Cash Flows for the Three Months Ended March 31, 2020 and 2019 (unaudited)		7
	Notes to Condensed Financial Statements (unaudited)		8
ITEM 2.	MANAGEMENT’S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS OF OPERATIONS		21
ITEM 3.	QUANTITATIVE AND QUALITATIVE DISCLOSURES ABOUT MARKET RISK		27
ITEM 4.	CONTROLS AND PROCEDURES		27

PART II	OTHER INFORMATION		28

ITEM 1.	LEGAL PROCEEDINGS		28
ITEM 1A.	RISK FACTORS		28
ITEM 2.	UNREGISTERED SALES OF EQUITY SECURITIES AND USE OF PROCEEDS		28
ITEM 3.	DEFAULTS UPON SENIOR SECURITIES		28
ITEM 4.	MINE SAFETY DISCLOSURE		28
ITEM 5.	OTHER INFORMATION		28
ITEM 6.	EXHIBITS		29
SIGNATURES		30

This Quarterly Report on Form 10-Q contains forward-looking statements which are made pursuant to the safe harbor provisions of Section 27A of the Securities Act of 1933, as amended (the “Securities Act”), and Section 21E of the Securities Exchange Act of 1934, as amended (the “Exchange Act”). These statements may be identified by such forward-looking terminology as “may,” “should,” “expects,” “intends,” “plans,” “anticipates,” “believes,” “estimates,” “predicts,” “potential,” “continue” or the negative of these terms or other comparable terminology. Our forward-looking statements are based on a series of expectations, assumptions, estimates and projections about our company, are not guarantees of future results or performance and involve substantial risks and uncertainty. We may not actually achieve the plans, intentions or expectations disclosed in these forward-looking statements. Actual results or events could differ materially from the plans, intentions and expectations disclosed in these forward-looking statements. Our business and our forward-looking statements involve substantial known and unknown risks and uncertainties, including the risks and uncertainties inherent in our statements regarding:

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our business strategies;

●

the timing of regulatory submissions;

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our ability to obtain and maintain regulatory approval of our existing product candidates and any other product candidates we may develop, and the labeling under any approval we may obtain;

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risks relating to the timing and costs of clinical trials, the timing and costs of other expenses;

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the ultimate impact of the current coronavirus pandemic, or any other health epidemic, on our business, our clinical trials, our research programs, healthcare systems or the global economy as a whole;

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risks related to market acceptance of products;

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intellectual property risks;

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risks associated with our reliance on third party organizations;

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our competitive position;

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our industry environment;

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our anticipated financial and operating results, including anticipated sources of revenues;

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assumptions regarding the size of the available market, benefits of our products, product pricing, timing of product launches;

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management’s expectation with respect to future acquisitions;

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statements regarding our goals, intensions, plans and expectations, including the introduction of new products and markets; and

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our cash needs and financing plans.

All of our forward-looking statements are as of the date of this Quarterly Report on Form 10-Q only. In each case, actual results may differ materially from such forward-looking information. We can give no assurance that such expectations or forward-looking statements will prove to be correct. An occurrence of, or any material adverse change in, one or more of the risk factors or risks and uncertainties referred to in this Quarterly Report on Form 10-Q or included in our other public disclosures or our other periodic reports or other documents or filings filed with or furnished to the U.S. Securities and Exchange Commission (the “SEC”) could materially and adversely affect our business, prospects, financial condition and results of operations. Except as required by law, we do not undertake or plan to update or revise any such forward-looking statements to reflect actual results, changes in plans, assumptions, estimates or projections or other circumstances affecting such forward-looking statements occurring after the date of this Quarterly Report on Form 10-Q, even if such results, changes or circumstances make it clear that any forward-looking information will not be realized. Any public statements or disclosures by us following this Quarterly Report on Form 10-Q that modify or impact any of the forward-looking statements contained in this Quarterly Report on Form 10-Q will be deemed to modify or supersede such statements in this Quarterly Report on Form 10-Q.

This Quarterly Report on Form 10-Q may include market data and certain industry data and forecasts, which we may obtain from internal company surveys, market research, consultant surveys, publicly available information, reports of governmental agencies and industry publications, articles and surveys. Industry surveys, publications, consultant surveys and forecasts generally state that the information contained therein has been obtained from sources believed to be reliable, but the accuracy and completeness of such information is not guaranteed. While we believe that such studies and publications are reliable, we have not independently verified market and industry data from third-party sources.

PART I - FINANCIAL INFORMATION

Item 1. Financial Statements.

Genprex, Inc.

Condensed Balance Sheets (unaudited)

	March 31,			December 31,
	2020			2019
Assets
Current assets:
Cash	$	23,079,591		$	2,002,492
Accounts receivable		—			655
Prepaid expenses and other		69,568			171,716
Supplies		882,637			801,780
Total current assets		24,031,796			2,976,643
Property and equipment, net		50,713			44,654
Other assets:
Security deposits		21,732			21,732
Intellectual property, net		535,944			491,200
Total other assets		557,676			512,932
Total assets	$	24,640,185		$	3,534,229
Liabilities and Stockholders’ Equity
Current liabilities:
Accounts payable and accrued expenses	$	638,392		$	436,258
Other current liabilities		58,834			74,426
Total current liabilities		697,226			510,684
Investment unit		—			—
Commitments and contingencies		—			—
Stockholders’ equity:
Preferred stock $0.001 par value: 10,000,000 shares authorized; no shares issued and outstanding		—			—
Common stock $0.001 par value: 200,000,000 shares authorized; 32,849,841 and 19,263,841 shares issued and outstanding, respectively		32,850			19,264
Additional paid-in capital		69,955,788			43,483,740
Accumulated deficit		(46,045,679	)		(40,479,459	)
Total stockholders’ equity		23,942,959			3,023,545
Total liabilities and stockholders’ equity	$	24,640,185		$	3,534,229

See accompanying notes to the unaudited condensed financial statements.

Genprex, Inc.

Condensed Statements of Operations (unaudited)

	Three Months Ended
	March 31,
	2020			2019
Revenues	$	—		$	—
Cost and expenses:
Depreciation		5,353			2,931
Research and development		1,477,877			508,042
General and administrative		4,092,996			1,659,796
Total costs and expenses		5,576,226			2,170,769
Operating loss		(5,576,226	)		(2,170,769	)
Interest income		10,006			11,923
Net loss	$	(5,566,220	)	$	(2,158,846	)
Net loss per share—basic and diluted	$	(0.20	)	$	(0.14	)
Weighted average number of common shares— basic and diluted		27,952,742			15,335,772

See accompanying notes to the unaudited condensed financial statements.

Genprex, Inc.

Condensed Statements of Changes in Stockholders' Equity (unaudited)

	Common Stock				Preferred Stock				Additional		Accumulated
	Shares		Amount		Shares		Amount		Paid-In Capital		Deficit			Total
Balance at December 31, 2018		15,239,148	$	15,240		—	$	—	$	38,690,586	$	(29,824,691	)	$	8,881,135
Issuance of stock for cash		200,000		200		—		—		—		—			200
Issuance of stock for services		121,617		122		—		—		—		—			122
Share based compensation		—		—		—		—		522,700		—			522,700
Net loss		—		—		—		—		—		(2,158,846	)		(2,158,846	)
Balance at March 31, 2019		15,560,765	$	15,562		—	$	—	$	39,213,286	$	(31,983,537	)	$	7,245,311

Balance at December 31, 2019		19,263,841	$	19,264		—	$	—	$	43,483,740	$	(40,479,459	)	$	3,023,545
Issuance of stock for cash		13,581,000		13,581		—		—		25,718,059		—			25,731,640
Issuance of stock for services		5,000		5		—		—		1,545		—			1,550
Share based compensation		—		—		—		—		752,444		—			752,444
Net loss		—		—		—		—		—		(5,566,220	)		(5,566,220	)
Balance at March 31, 2020		32,849,841	$	32,850		—	$	—	$	69,955,788	$	(46,045,679	)	$	23,942,959

See accompanying notes to the unaudited condensed financial statements.

Genprex, Inc.

Condensed Statements of Cash Flows (unaudited)

	Three Months Ended March 31,
	2020			2019
Cash flows from operating activities:
Net loss	$	(5,566,220	)	$	(2,158,846	)
Adjustments to reconcile net loss to net cash used in operating activities:
Depreciation		5,353			2,931
Share based compensation		753,994			523,022
Changes in operating assets and liabilities:
Accounts receivable		655			9,297
Prepaid expenses and other		102,148			136,593
Deposits		—			1,950
Accounts payable and accrued expenses		202,134			(88,818	)
Other current liabilities		(15,592	)		(67,922	)
Net cash used in operating activities		(4,517,528	)		(1,641,793	)
Cash flows from investing activities:
Additions to property and equipment		(11,412	)		(4,111	)
Additions to intellectual property		(44,744	)		(9,220	)
Additions to research and development supplies		(80,857	)		—
Net cash used in investing activities		(137,013	)		(13,331	)
Cash flows from financing activities:
Proceeds from issuances of stock		25,731,640			—
Net cash provided by financing activities		25,731,640			—
Net increase (decrease) in cash		21,077,099			(1,655,124	)
Cash, beginning of period		2,002,492			8,600,918
Cash, end of period	$	23,079,591		$	6,945,794

Supplemental Disclosure of Cash Flow Information
Cash paid for interest	$	—		$	—
Cash paid for taxes	$	—		$	—

See accompanying notes to the unaudited condensed financial statements.

GENPREX, INC.

NOTES TO UNAUDITED CONDENSED FINANCIAL STATEMENTS

Note 1 - Description of Business and Basis of Presentation

Genprex, Inc. ("we" or "the Company") is a clinical stage gene therapy company developing potentially life-changing treatments for cancer and diabetes. Our cancer therapies are based upon our novel proprietary technology platform, including our lead drug candidate, Oncoprex™ immunogene therapy ("Oncoprex"), for non-small cell lung cancer ("NSCLC"). Oncoprex consists of a tumor suppressor gene inserted into a patient’s cells that has immunomodulatory effects and is thereby considered an “immunogene therapy”. The gene is one of a series of genes whose therapeutic use is covered by an exclusive worldwide license from The University of Texas MD Anderson Cancer Center ("MD Anderson"). We also are developing a pre-clinical gene therapy that is covered by an exclusive worldwide license from the University of Pittsburgh of the Commonwealth System of Higher Education that has the potential to cure type 1 and type 2 diabetes. This potential treatment works by transforming alpha cells in the pancreas into functional beta-like cells, which can produce insulin but are distinct enough from beta cells to evade the body’s immune system.

Oncology Platform Technologies

Our oncology platform technologies are designed to administer cancer fighting genes by encapsulating them into nanoscale hollow spheres called nanovesicles, which are then administered intravenously and taken up by tumor cells where they express proteins that are missing or found in low quantities. Oncoprex has a multimodal mechanism of action whereby it interrupts cell signaling pathways that cause replication and proliferation of cancer cells, re-establishes pathways for apoptosis, or programmed cell death, in cancer cells, and modulates the immune response against cancer cells. Oncoprex has also been shown to block mechanisms that create drug resistance.

With Oncoprex, we are initially targeting NSCLC. According to the World Health Organization, in 2018 lung cancer was the leading cause of cancer deaths worldwide, causing more deaths than colorectal, breast, liver or stomach cancers. In 2018, there were more than 2 million new lung cancer cases and 1.7 million deaths from lung cancer worldwide. In the United States, according to the American Cancer Society, it is estimated that in 2020 there will be more than 228,000 new cases of lung cancer and more than 135,000 deaths from lung cancer. The American Society of Clinical Oncology reports that NSCLC represents 84 percent of all lung cancers and has a 24 percent five-year relative survival rate. However, according to the National Cancer Institute, 57 percent of lung cancer diagnoses are distant, or have metastasized, and the five-year relative survival rate for Stage IV (metastatic) NSCLC is approximately 5 percent. We believe that there is a significant unmet medical need for new treatments for NSCLC in the United States and globally, and we believe that Oncoprex may be suitable for a majority of NSCLC patients.

In January 2020, we received a United States Food and Drug Administration ("FDA") Fast Track Designation for use of Oncoprex in combination with epidermal growth factor receptor ("EGFR") inhibitor osimertinib (AstraZeneca’s Tagrisso®) for the treatment of NSCLC patients with EFGR mutations whose tumors progressed after treatment with osimertinib alone. According to the FLAURA study sponsored by AstraZeneca, the median length of time that patients are treated with osimertinib before their tumors progress is approximately 18 months. Osimertinib is now considered a new standard of care for NSCLC patients with an EGFR mutation. Given this and receipt of FDA’s Fast Track Designation for use of Oncoprex combined with osimertinib in patients whose tumors progress on osimertinib, we are prioritizing this drug combination and patient population and plan to initiate a Phase I/II clinical trial of Oncoprex combined with osimertinib in late 2020 or early 2021.

In 2019, preclinical data was presented by MD Anderson collaborators for the combination of TUSC2, the active agent in Oncoprex, with pembrolizumab (Merck’s Keytruda®), showing that TUSC2 combined with the checkpoint blockade mechanism of action of pembrolizumab was more effective than pembrolizumab alone in increasing the survival of mice with human immune cells (humanized mice) that had metastatic lung cancer. Also presented in 2019 by MD Anderson was pre-clinical data for the combination of TUSC2, pembrolizumab and chemotherapy for the treatment of some of the most resistant metastatic lung cancers. This study found that the addition of TUSC2, increases the effectiveness of pembrolizumab and chemotherapy, and thus, may improve on first-line standard of care for lung cancer. In early May 2020, we entered into a worldwide, exclusive license agreement with The Board of Regents of the University of Texas System on Behalf of MD Anderson for the use of TUSC2 in combination with immunotherapies, including pembrolizumab.

We believe that our platform technologies could allow delivery of a number of cancer fighting genes, alone or in combination with other cancer therapies, to combat multiple types of cancer. We believe that Oncoprex’s combination of pan-kinase inhibition, direct induction of apoptosis, anti-cancer immune modulation and complementary action with targeted drugs and immunotherapies is unique, and positions Oncoprex to provide treatment for patients with NSCLC and possibly other cancers, who are not benefitting from currently offered therapies.

Diabetes Gene Therapy

Diabetes is a chronic, metabolic disease characterized by elevated levels of blood glucose (or blood sugar), which leads over time to serious damage to the heart, blood vessels, eyes, kidneys and nerves. The most common is type 2 diabetes, usually in adults, which occurs when the body becomes resistant to insulin or does not make enough insulin. In the past three decades the prevalence of type 2 diabetes has risen dramatically. Type 1 diabetes, once known as juvenile diabetes or insulin-dependent diabetes, is a chronic condition in which the pancreas produces little or no insulin by itself. According to the International Diabetes Federation, in 2019 approximately 463 million people worldwide had diabetes and 4.2 million deaths were attributed to diabetes. Both the number of cases and the prevalence of diabetes have been steadily increasing over the past few decades.

Our diabetes gene therapy was developed by lead researcher Dr. George Gittes, at the Rangos Research Center at UPMC Children’s Hospital of Pittsburgh. The therapy utilizes an infusion process in which an endoscope and an adeno-associated virus vector are used to deliver Pdx1 and MafA genes to the pancreas. The proteins these genes express have been shown to transform alpha cells in the pancreas into functional beta-like cells, which can produce insulin but are distinct enough from beta cells to evade the body’s immune system.

The diabetes gene therapy has been tested in vivo in mice and nonhuman primates. In studies of diabetic mice, the gene therapy approach restored normal blood glucose levels for an extended period of time, typically around four months. According to Dr. Gittes, the duration of restored blood glucose levels in mice could translate to decades in humans. If successful, this gene therapy could eliminate the need for insulin replacement therapy for diabetic patients.

Capital Requirements, Liquidity and Going Concern Considerations

Our condensed financial statements are prepared using the generally accepted accounting principles (“GAAP”) applicable to a going concern, which contemplates the realization of assets and liquidation of liabilities in the normal course of business. However, as shown in the accompanying condensed financial statements, we have sustained substantial losses from operations since inception and have no current source of revenue. In addition, we have used, rather than provided, cash in our operations. We expect to continue to incur significant expenditures to further clinical trials for the commercial development of our product candidates.

Management recognizes that we must obtain additional capital resources to successfully commercialize our product candidates. To date, we have received funding in the form of equity and debt, and we plan to seek additional funding in the future. However, no assurances can be given that we will be successful in raising additional capital. If we are not able to timely and successfully raise additional capital, the timing of our clinical trials, financial condition and results of operations will continue to be materially and adversely affected. These condensed financial statements do not include any adjustments relating to the recoverability and classification of recorded asset amounts and classification of liabilities.

Note 2 - Summary of Significant Accounting Policies

The Company’s condensed financial statements have been prepared in accordance with GAAP. However, they do not include all the information and footnotes required by GAAP for complete financial statements. In our opinion the unaudited condensed financial statements include all adjustments (consisting of normal recurring accruals) necessary to make the unaudited condensed financial statements not misleading. Operating results for the three months ended March 31, 2020 and 2019 are not necessarily indicative of the final results that may be expected for the year ending December 31, 2020. For more complete financial information, these unaudited condensed financial statements should be read in conjunction with the Company's audited financial statements for the year ended December 31, 2019 filed with the Securities and Exchange Commission (“SEC”) on March 30, 2020. A summary of our significant accounting policies consistently applied in the preparation of the accompanying condensed financial statements follows.

Capital Stock

In connection with the Company’s initial public offering ("IPO") in April 2018, all of the Company’s preferred stock and non-voting common stock were converted into shares of the Company’s common stock. The Company’s common stock was then forward-split at a ratio of 6.6841954-to-1. Furthermore, prior to the closing of the IPO, the Company’s Certificate of Incorporation was amended and restated to provide the Company with the authority to issue up to 210,000,000 shares of stock consisting of 200,000,000 shares of common stock at a par value of $0.001 per share and 10,000,000 shares of preferred stock at a par value of $0.001 per share.

Use of Estimates

The preparation of our condensed financial statements in conformity with GAAP requires us to make estimates and assumptions that affect the reported amounts of assets and liabilities and disclosure of contingent assets and liabilities at the date of the condensed financial statements and the reported amounts of expenses during the reporting period. Actual results could differ from those estimates.

Cash

We consider all highly liquid short-term investments with an initial maturity of three months or less to be cash equivalents. Any amounts of cash in financial institutions which exceed FDIC insured limits expose us to cash concentration risk. We have no cash equivalents, and had $22,829,591 and $1,761,278 in excess of FDIC insured limits of $250,000 at March 31, 2020 and December 31, 2019, respectively.

Fair Value of Financial Instruments

The carrying amounts reported in the balance sheet for cash, accounts receivable, accounts payable and accrued expenses approximate fair value because of the immediate or short-term maturity of these financial instruments.

Accounting Standard Codification ("ASC") 820, Fair Value Measurements and Disclosures, defines fair value, provides a consistent framework for measuring fair value under GAAP and expands fair value financial statement disclosure requirements. ASC 820’s valuation techniques are based on observable and unobservable inputs. Observable inputs reflect readily obtainable data from independent sources, while unobservable inputs reflect our market assumptions. ASC 820 classifies these inputs into the following hierarchy:

Level 1: Quoted prices for identical instruments in active markets

Level 2: Quoted prices for similar instruments in active markets; quoted prices for identical or similar instruments in markets that are not active; and model-derived valuations whose inputs are observable or whose significant value drivers are observable

Level 3: Instruments with primarily unobservable value drivers.

Property and Equipment

Furniture and equipment are stated at cost. Depreciation is calculated using the straight line method over the estimated useful lives of the assets, which range from three to five years. Routine maintenance and repairs are charged to expense as incurred and major renovations or improvements are capitalized.

Research and Development Costs

Research and development expenditures are comprised of costs incurred to conduct research and development activities. These include payments to collaborative research partners, manufacturing, and clinical strategy partners, wages and associated employee benefits, facilities and overhead costs. These expenditures relate to our preclinical, Phase I, and Phase II clinical trials and are expensed as incurred. Purchased materials to be used in future research are capitalized and included in research and development supplies. Supplies purchased and capitalized for future use was $882,637 and $801,780 at March 31, 2020 and December 31, 2019, respectively.

Awards

In 2010, we were awarded $4.5 million from the State of Texas Emerging Technology Fund (“TETF”). The award was received in two tranches of $2.25 million during 2010 and 2011. The award proceeds were used for the development and future commercialization of our nanomolecular therapy product for the treatment of cancer. In consideration for the award, we provided the TETF with an “Investment Unit,” consisting of (i) a Promissory Note (“Note”) and (ii) a right to purchase our equity shares (“Warrant”). The funds received for this award were assigned to the Investment Unit, and classified separately from equity as “mezzanine” in the balance sheet.

In 2010, we also were awarded approximately $244,500 from the U.S. Treasury Department for our QTDP Program Nanoparticle Therapy for Lung Cancer. The award was received during 2011 for our historical activities, and required no prospective expenditures. We accounted for these funds received as revenue at that time.

Intellectual Property

Intellectual property consists of external legal and related costs associated with patents and other proprietary technology acquired, licensed by, or maintained by us that we believe contribute to a probable economic benefit toward such patents and activities. These legal costs incurred in connection with the patent applications and patent maintenance are capitalized. Intellectual property is stated at cost, to be amortized on a straight-line basis over the estimated useful lives of the assets.

Accounting for Stock-Based Compensation

We use the fair value-based method of accounting for stock-based compensation for options granted to employees, independent consultants and contractors. We measure options granted at fair value determined as of the grant date, and recognize the expense over the periods in which the related services are rendered based on the terms and conditions of the award. Generally, where the award only has a service condition, the requisite service period is the same as the vesting period.

Financial Instruments

We have elected the Fair Value Option to account for the Investment Unit at fair value as a combined hybrid financial instrument containing a Warrant and a Note (see Note 4 - Investment Unit). Prior to its exercise, the Warrant component was not classified within equity, as the exercise price of the Warrant was affected by the market price of our stock in a future qualifying financing transaction and was not considered to be indexed to our own stock. The Note is not classified within liabilities, as our management can determine the timing of the repayment obligation, if any. As a result, the Warrant and Note that comprised the Investment Unit were aggregated and classified within the mezzanine section of the balance sheet.

Due to the contingent terms of the financial instruments, changes in the fair value of the Investment Unit were calculated and realized in earnings. In August 2019, the remaining articles of the Investment Unit were terminated. There were no changes in the fair value of the Investment Unit at March 31, 2020.

Long-Lived Assets

We review long-lived assets and certain identifiable intangibles held and used for possible impairment whenever events or changes in circumstances indicate that the carrying amount of an asset may not be recoverable. In evaluating the fair value and future benefits of its intangible assets, management performs an analysis of the anticipated undiscounted future net cash flow of the individual assets over the remaining amortization period. We recognize an impairment loss if the carrying value of the asset exceeds the expected future cash flows. During the three months ended March 31, 2020 and the year ended December 31, 2019, there were no deemed impairments of our long-lived assets.

Recent Accounting Developments

Accounting pronouncements issued but not effective until after March 31, 2020 are not expected to have a significant effect on our financial condition, results of operations, or cash flows.

Note 3 - Intellectual Property

On February 11, 2020, we entered into an exclusive license agreement with the University of Pittsburgh for patented gene therapy technologies relating to the potential treatment of Type 1 and Type 2 diabetes.

We have exclusive license agreements on 34 issued patents for technologies developed by researchers at the National Cancer Institute, MD Anderson, the University of Texas Southwestern Medical Center, and the University of Pittsburgh. These patents comprise various therapeutic, diagnostic, technical and processing claims. These license rights will be amortized on a straight-line basis over the estimated period of useful lives of the underlying patents or the license agreements.

Note 4 - Investment Unit

The TETF was created as an incentive for economic development to the Texas economy by providing financial support that leverages private investment for the creation of high-quality technology jobs in Texas. The award received required us to comply with certain performance conditions to ensure the monies the Company received were used for development activities in the State of Texas, and to maintain our corporate nexus in Texas. Further, in connection with the award, the Company issued the Investment Unit to the TETF. On September 25, 2017 and again on August 16, 2019, the Company entered into termination agreements with the Texas Treasury Safekeeping Trust Company, the entity managing and controlling TETF interests, which terminated Article II and all remaining Articles of the Investment Unit, respectively, so that the entirety of the Investment Unit was effectively terminated. As further described below, the Investment Unit consisted of a Note and a Warrant.

Promissory Note

The Note was an obligation to repay the $4.5 million principal amount, with interest accrued at 8% per annum, but only if an event of default occurred prior to August 13, 2020. If no event of default occurred prior to August 13, 2020, the Note and all related interest would be cancelled.

Consistent with the stated objectives of the TETF, an event of default that would trigger the repayment obligation under the Note was a failure to maintain our principal place of business or our principal executive offices headquartered in the State of Texas (referred to as the “Texas Residency Requirement”) until August 13, 2020.

Warrant

The Warrant was an obligation to issue (a Right to Purchase by the TETF) shares of the same class of stock to be issued in a “First Qualifying Financing Transaction,” at 80% of the per share transaction value (effectively a 20% discount). Alternatively, the TETF could exercise its right to purchase at any time prior to the occurrence of a First Qualifying Financing Transaction for $0.001 per share.

The Warrant included a provision that required changes in the strike price, driven by the pricing of the “First Qualifying Financing Transaction.” As a result, the Warrant embedded in the Investment Unit was accounted for as a derivative financial instrument and classified outside of equity under ASC 815-40-15, as the settlement adjustment from the future transaction did not permit for the strike price to be considered fixed.

On March 12, 2014, the TETF exercised its Warrant for $0.001 per share, and we issued to the TETF an aggregate of 184,797 shares of our Series B preferred stock. These shares were subsequently forward-split and converted into an aggregate of 1,235,219 shares of our common stock in connection with our IPO.

Accounting for the Investment Unit

We accounted for the Investment Unit as a hybrid financial instrument under Financial Accounting Standards Board Statement 155, and measured the Investment Unit at the amount of proceeds received from the TETF award. The First Qualifying Financing Transaction occurred during December 2013, resulting in an adjustment to the fair value of the Investment Unit in the amount of approximately $2.5 million. The TETF exercised the Warrant for $0.001 per share. We received notice of exercise from the TETF during March 2014, and issued 184,797 shares of Series B preferred stock, which were converted to 1,235,219 shares of our common stock upon completion of our IPO. Upon exercise by the TETF of the Warrant, the remaining component within the Investment Unit was the Note. The Investment Unit was valued at zero, because our obligation to repay the Note arose from an event of default (a failure to maintain the Texas Residency Requirement), which was an event which rested entirely within our control.

Note 5 - Equity

Registered Direct Offerings

On November 22, 2019, the Company completed a registered direct offering (“2019 RDO”), whereby the Company sold to investors an aggregate of 3,167,986 shares of the Company’s common stock at $0.40 per share and warrants to purchase up to 3,167,986 shares of the Company’s common stock at an exercise price of $0.46 per share. The warrants are first exercisable on May 22, 2020. The Company received net proceeds of approximately $1,093,000 after commissions and expenses. Additionally, the placement agent has been issued warrants to purchase common stock equal to 7% of the aggregate number of shares of common stock issued and issuable pursuant to the 2019 RDO (including shares underlying any warrants), or 443,518 shares of common stock at an exercise price of 125% of the 2019 RDO price per share, or $0.50 per share.

In connection with the closing of the 2019 RDO, the Company further adjusted the warrants to purchase up to 2,283,740 shares of the Company's common stock, which had been issued as part of the Company's May 9, 2018 private placement and adjusted in August 2018 to (i) reduce the exercise price for each share from $4.25 per share to $0.46 per share, (ii) extend the date upon which such warrants could be initially exercised to May 22, 2020, and (iii) extend the termination date of such warrants by six months and one day.

On January 21, 2020, the Company completed a registered direct offering, in which the Company sold to an accredited investor 961,000 shares of the Company’s common stock at $0.24 per share. The Company received net proceeds of approximately $200,000 after commissions and expenses.

On January 23, 2020, the Company completed a registered direct offering, in which the Company sold to investors an aggregate of 7,620,000 shares of the Company’s common stock at $1.05 per share. The Company received net proceeds of approximately $7.2 million after commissions and expenses.

On February 19, 2020, the Company amended its Registration Statement on Form S-3 to increase the maximum offering size by approximately $3,000,000. On February 21, 2020, the Company completed a registered direct offering under the amended S-3 Registration Statement, in which the Company sold to investors an aggregate of 5,000,000 shares of the Company’s common stock at $3.50 per share. The Company received net proceeds of approximately $16 million after commissions and expenses.

Stock Issuances

During the three months ended March 31, 2020, we issued (i) 13,581,000 shares of common stock in the Company's registered direct offerings for cash of $25,731,640, and (ii) 5,000 shares of common stock for service provided to us, valued at $1,550.

During the year ended December 31, 2019, we issued (i) 3,167,986 shares of common stock in the 2019 RDO for cash of $1,267,194, (ii) 506,707 shares of common stock for services provided to us, valued at $469,588, and (iii) 350,000 shares of common stock held in abeyance for an investor in our May 9, 2018 private placement.

Preferred Stock

In connection with the Company’s IPO, all preferred stock included in Series A through Series G preferred stock, totaling 1,394,953 shares at March 31, 2018 were converted to an aggregate of 9,324,177 shares of the Company's common stock in association with the forward-split (See Note 2 - Capital Stock). Upon the completion of the IPO, the Company became authorized to issue 10,000,000 shares of preferred stock with a par value of $0.001 per share, none of which are outstanding at March 31, 2020.

Common Stock

Upon the completion of the IPO, all of the Company’s non-voting common stock automatically converted into voting common stock on a one-to-one basis. Immediately following the completion of the IPO, the Company became authorized to issue 200,000,000 shares of common stock with a par value of $0.001 per share, all of which are voting common stock. There are 32,849,841 shares of common stock outstanding at March 31, 2020.

Common Stock Purchase Warrants

Common stock purchase warrant activity for the period and year ended March 31, 2020 and December 31, 2019, respectively, are as follows:

	Number of		Weighted Avg.
	Warrants		Exercise Price
Outstanding at January 1, 2019		3,864,552	$	2.36
Issued		3,611,504		0.46
Cancelled or expired		—		—
Exercised		—		—
Outstanding at December 31, 2019		7,476,056	$	1.45
Issued		—		—
Cancelled or expired		—		—
Exercised		—		—
Outstanding at March 31, 2020		7,476,056	$	1.45

The Company did not issue warrants in the three-month period ended March 31, 2020.

In the year ended December 31, 2019, we (i) issued warrants to purchase 3,167,986 shares of our common stock at an exercise price of $0.46 per share to the investors in the 2019 RDO, (ii) issued warrants to purchase 443,518 shares of our common stock at an exercise price of $0.50 per share to the placement agent in the 2019 RDO, and (iii) reduced the purchase price of the warrants, issued to investors in the May 9, 2018 private placement, to purchase 2,283,740 shares of the Company’s common stock from $4.25 per share to $0.46 per share.

On January 29, 2018, the Company entered into an agreement with FundAthena, Inc. whereby the Company agreed to grant warrants to purchase 6,000 shares of common stock at an exercise price of $5.00 per share in consideration of services valued at $30,000 provided to the Company. At March 31, 2020, the Company has not issued these warrants.

2018 Equity Incentive Plan

The Company’s board of directors and stockholders have approved and adopted the Company’s 2018 Equity Incentive Plan (“2018 Plan”), which became effective on the completion of the IPO on April 3, 2018. The 2018 Plan provides for the grant of incentive stock options (“ISOs”), nonstatutory stock options, stock appreciation rights, restricted stock awards, restricted stock unit awards, performance-based stock awards, other forms of equity compensation and performance cash awards. ISOs may be granted only to employees. All other awards may be granted to employees, including officers, and to the Company’s non-employee directors and consultants.

A total of 4,160,000 shares of common stock are available under the 2018 Plan, which includes 554,963 shares of common stock reserved for issuance under our 2009 Equity Incentive Plan that were added to the 2018 Plan. No grants have been made under the 2009 Plan since our IPO, and no further grants will be made under the 2009 Plan. Any shares subject to outstanding stock options under the 2009 Plan that would otherwise be returned to the 2009 Plan will instead be added to the shares initially reserved under the 2018 Plan.

In addition, the number of shares of common stock reserved for issuance under the 2018 Plan will automatically increase on January 1 of each year, beginning on January 1, 2019 by 5% of the total number of shares of the Company’s common stock outstanding on December 31 of the preceding calendar year, or a lesser number of shares determined by the administrator of the 2018 Plan. On January 1, 2019 and 2020, the number of shares of common stock reserved for issuance under the 2018 Plan was increased by an aggregate of 761,957 and 963,192 shares, respectively.

2018 Employee Stock Purchase Plan

The Company’s board of directors and stockholders have approved and adopted the Company’s 2018 Employee Stock Purchase Plan (“ESPP”), which became effective on the completion of the IPO on April 3, 2019. The ESPP authorizes the issuance of 208,500 shares of the Company’s common stock pursuant to purchase rights granted to our eligible employees. The number of shares of common stock reserved for issuance will automatically increase on January 1 of each calendar year, from January 1, 2019 by the lesser of 2% of the total number of shares of our common stock outstanding on December 31 of the preceding calendar year or a number determined by the administrator of the ESPP. The administrator of the ESPP, which is our Board of Directors, determined not to increase the number of shares reserved for issuance under the ESPP on January 1, 2019 or January 1, 2020.

Stock Options

As of March 31, 2020, the Company has outstanding stock options to purchase 7,148,248 shares of common stock that have been granted to various employees, directors, and independent contractors. These options can vest immediately or over periods ranging from 12 to 48 months, are exercisable for a period of up to ten years, and enable the holders to purchase shares of our common stock at exercise prices ranging from $0.001 to $9.80 per share. The per-share fair values of these options range from $0.001 to $7.93, based on Black-Scholes-Merton pricing models with the following assumptions:

Expected term:		10 years
Risk-free rate:		0.21% – 2.63%
Volatility:		75.98% – 79.89%
Dividend yield:		0%

In the three-month period ending March 31, 2020, the Company granted stock options to employees and consultants to purchase an aggregate of 1,165,325 shares of the Company's common stock with exercise prices ranging from $1.28 to $2.67 per share.

In the year ending December 31, 2019, Company granted stock options to employees and consultants to purchase an aggregate of 1,744,300 shares of common stock with exercise prices ranging from $0.30 to $1.62 per share and cancelled options to purchase 297,058 shares of common stock due to the inactivity of service providers.

The weighted average remaining contractual term for the outstanding options at March 31, 2020 and December 31, 2019 is 7.64 and 7.45 years, respectively.

Stock option activity for the three months and year ended March 31, 2020 and December 31, 2019, respectively, is as follows:

	Number of			Weighted Avg.
	Shares			Exercise Price
Outstanding at January 1, 2019		4,535,681		$	3.31
Options granted		1,744,300			1.48
Options exercised		—			—
Options expired		(297,058	)		—
Outstanding at December 31, 2019		5,982,923		$	2.66
Options granted		1,165,325			2.00
Options exercised		—			—
Options expired or cancelled		—			—
Outstanding at March 31, 2020		7,148,248		$	2.55

Share-Based Compensation

The Company’s total compensation cost related to non-vested time-based stock option awards granted to employees and board members and not yet recognized was approximately $5.3 million for the quarter ended March 31, 2020. The Company expects to record this stock-based compensation expense over the next three years in the amount of $5.2 million with respect to stock option awards using a graded vesting method and $0.1 million with respect to stock option awards using a cliff vesting method. As of March 31, 2020, the weighted average term over which these expenses are expected to be recognized are 2.21 years and 0.25 years, for stock options granted using a graded vesting method and a cliff vesting method, respectively.

As of March 31, 2020, the Company’s total compensation cost related to non-vested performance-based stock option awards granted to an employee and not yet recognized was approximately $1.3 million. The entirety of this award may be recognized and recorded, upon the achievement of certain milestones, within 1.1 years from March 31, 2020.

In the three months ended March 31, 2020, the Company's total share-based compensation was approximately $0.75 million, all of which represents the vesting of options issued to service providers, employees, and board members.

Note 6 - Related Party Transactions

Introgen Research Institute

Introgen Research Institute (“IRI”) is a Texas-based technology company, currently affiliated with Rodney Varner, our Chief Executive Officer. In April 2009, prior to Mr. Varner becoming an officer and director of our Company in August 2012, we entered into an Assignment and Collaboration Agreement with IRI, providing us with the exclusive right to commercialize a portfolio of intellectual property. This agreement was amended in 2011 to include additional sublicensing of additional intellectual property made available to IRI from MD Anderson.

Viet Ly

The Company entered into a consulting agreement with Viet Ly on April 19, 2018. The Company agreed to pay Mr. Ly $175,000 initially, with compensation variable from time-to-time as determined by the Company, for strategic consulting services. The Company paid Mr. Ly $6,000 per month, or an aggregate of $18,000, during the period ended March 31, 2020 for strategic services.

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 in Cambridge, Massachusetts. 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 in Austin, Texas. The Company pays $2,050 per month to occupy this location and the lease is effective until April 30, 2020. The Company is currently negotiating an extension of the lease.

Commitments

MD Anderson Cancer Center

We have entered into a clinical study agreement with MD Anderson in Houston, Texas, to administer a Phase I/II clinical trial, combining FUS1-nanoparticles and erlotinib in Stage IV lung cancer patients. FUS1 is sometimes referred to as TUSC2. 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. With osimertinib now considered a new standard of care in the U.S. for NSCLC with an EGFR mutation and our receipt of FDA Fast-Track Designation for use of Oncoprex combined with osimertinib, we are prioritizing this program in lieu of the combination trial of Oncoprex and erlotinib.

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 TUSC2 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.

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 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.

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 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 which increases annually by $20,000 and is $280,000 as of December 31, 2019 will be recognized when we obtain regulatory approval (the event that triggers the payment obligation).

University of Pittsburgh

As part of our License Agreement with the University of Pittsburgh in February 2020, we agreed to (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 between 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) milestone payments of an aggregate of $3,975,000.

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.

Note 8 - Significant Events

In March 2020, the outbreak of COVID-19 caused by a novel strain of the coronavirus was recognized as a pandemic by the World Health Organization. The pandemic has become increasingly widespread in the United States, including markets in which the Company operates or may operate in the future. The COVID-19 pandemic has had a notable impact on general economic conditions, including, but not limited to, the temporary closures of many businesses, “shelter in place” orders and other governmental regulations, reduced consumer spending due to both job losses and other effects attributable to the COVID-19, in addition to many other unknowns. The Company has not experienced any material impact on financial results or operations during the three-month period ended March 31, 2020 as a result of the COVID-19 pandemic. The extent to which the COVID-19 pandemic could impact the Company's operations or financial results is uncertain. The Company continues to monitor the impact of the COVID-19 pandemic closely.

Note 9 - Subsequent Events

Lease Cancellation

On April 1, 2020, the Company provided notice of cancellation of our lease in the Cambridge Innovation Center in Cambridge, Massachusetts, effective on April 30, 2020.

Share Issuance

On April 1, 2020, the Company issued 5,000 shares of stock to a service provider in consideration of services to be provided through June 30, 2020.

Option Issuance

On April 24, 2020, the Company granted stock options to a new employee to purchase 50,000 shares of common stock.

Warrant Issuance

On April 24, 2020, the Company issued a warrant to purchase 500,000 shares of common stock at an exercise price of $2.27 per share to a related party in conjunction with past and future services provided to the Company.

Separation Agreement with President & CSO

On April 27, 2020, Dr. Julien Pham resigned as the Company's President and Chief Scientific Officer. In connection with Dr. Pham’s resignation, the Company entered into a Separation Agreement with him pursuant to which Dr. Pham provided a general release of any claims of Dr. Pham against the Company and the others and will continue to comply with certain restrictive covenants and obligations of confidentiality and in return will be entitled to receive (i) payment of five months of Dr. Pham’s base salary of $375,000, or an aggregate of $156,250, (ii) reimbursement for five months of insurance coverage under the Consolidated Omnibus Budget Reconciliation Act, if incurred, (iii) accelerated vesting of stock options with time-based vesting that would have vested had Dr. Pham remained employed with the Company, with the total number of shares for which such newly vested options are exercisable being 410,117.

License Agreement

On May 4, 2020, the Company entered into an exclusive worldwide license agreement with The Board of Regents of the University of Texas System on Behalf of MD Anderson relating to a portfolio of 16 patent applications and related technology for the treatment of cancer using the Company’s lead drug candidate and immunotherapies.

Item 2. Management’s Discussion and Analysis of Financial Condition and Results of Operations

The following discussion and analysis of our financial condition and results of operations should be read in conjunction with our unaudited condensed financial statements and related notes included in this Quarterly Report on Form 10-Q and the audited financial statements and notes thereto as of and for the year ended December 31, 2019 and the related Management’s Discussion and Analysis of Financial Condition and Results of Operations, both of which are contained in our Annual Report on form 10-K filed with the Securities and Exchange Commission, or SEC, on March 30, 2020 (the "Annual Report"). Unless the context requires otherwise, references in this Quarterly Report on Form 10-Q to “we,” “us,” and “our” refer to Genprex, Inc.

Forward-Looking Statements

This Management’s Discussion and Analysis of Financial Condition and Results of Operations (“MD&A”) contains certain forward-looking statements. Historical results may not indicate future performance. Our forward-looking statements reflect our current views about future events, are based on assumptions and are subject to known and unknown risks and uncertainties that could cause actual results to differ materially from those contemplated by these statements. Factors that may cause differences between actual results and those contemplated by forward-looking statements include, but are not limited to, those discussed in “Risk Factors” as set forth in the Annual Report and in our other filings with the SEC. Except as required by law, we undertake no obligation to publicly update or revise any forward-looking statements, including any changes that might result from any facts, events, or circumstances after the date hereof that may bear upon forward-looking statements. Furthermore, we cannot guarantee future results, events, levels of activity, performance, or achievements.

Overview

Genprex™ is a clinical stage gene therapy company developing potentially life-changing treatments for cancer and diabetes. Our cancer therapies are based upon our novel proprietary technology platform, including our lead drug candidate, Oncoprex™ immunogene therapy ("Oncoprex"), for non-small cell lung cancer ("NSCLC"). Oncoprex consists of a tumor suppressor gene inserted into a patient’s cells that has immunomodulatory effects and is thereby considered an “immunogene therapy”. The gene is one of a series of genes whose therapeutic use is covered by an exclusive worldwide license from The University of Texas MD Anderson Cancer Center ("MD Anderson"). We also are developing a pre-clinical gene therapy that is covered by an exclusive worldwide license from the University of Pittsburgh of the Commonwealth System of Higher Education that has the potential to cure type 1 and type 2 diabetes. This potential treatment works by transforming alpha cells in the pancreas into functional beta-like cells, which can produce insulin but are distinct enough from beta cells to evade the body’s immune system.

Oncology Platform Technologies

Diabetes Gene Therapy

JOBS Act and Recent Accounting Pronouncements

The Jumpstart Our Business Startups Act of 2012, provides that an “emerging growth company” can take advantage of the extended transition period provided in Section 7(a)(2)(B) of the Securities Act of 1933, as amended, for complying with new or revised accounting standards. In other words, an “emerging growth company” can delay the adoption of certain accounting standards until those standards would otherwise apply to private companies. Although we are an emerging growth company, we have irrevocably elected not to avail ourselves of this extended transition period and, as a result, we will adopt new or revised accounting standards on the relevant dates on which adoption of such standards is required for other public companies.

We have implemented all new accounting pronouncements that are in effect and may affect our condensed financial statements, and we do not believe that there are any other new accounting pronouncements that have been issued that would have a material impact on our financial position or results of operations.

Critical Accounting Policies and Significant Judgments and Estimates

Our condensed financial statements have been prepared in accordance with GAAP. The preparation of these condensed financial statements requires us to make estimates and assumptions that affect the reported amounts of assets and liabilities and the disclosure of contingent assets and liabilities at the date of the condensed financial statements, as well as the reported expenses incurred during the reporting periods. Our estimates are based on our historical experience and on various other factors that we believe are reasonable under the circumstances, the results of which form the basis for making judgments about the carrying value of assets and liabilities that are not readily apparent from other sources. Actual results may differ from these estimates under different assumptions or conditions.

We believe that the following accounting policies are the most critical to aid in fully understanding and evaluating our reported financial results, and they require our most difficult, subjective or complex judgments, resulting from the need to make estimates about the effect of matters that are inherently uncertain.

Research and Development Costs

We record accrued expenses for costs invoiced from research and development activities conducted on our behalf by third-party service providers, which include the conduct of preclinical studies and clinical trials and use of contract research and manufacturing activities. We record the costs of research and development activities based upon the amount of services provided, and we include these costs in accrued liabilities in the balance sheets and within research and development expense in the statement of operations. These costs are a significant component of our research and development expenses. Purchased materials to be used in future research are capitalized and included in research and development supplies.

We estimate the amount of work completed through discussions with internal personnel and external service providers as to the progress or stage of completion of the services and the agreed-upon fee to be paid for such services. We make significant judgments and estimates in determining the accrued balance in each reporting period. As actual costs become known, we adjust our accrued estimates. Although we do not expect our estimates to be materially different from amounts actually incurred, our understanding of the status and timing of services performed, the number of patients enrolled and the rate of patient enrollment may vary from our estimates and could result in us reporting amounts that are too high or too low in any particular period. Our accrued expenses are dependent, in part, upon the receipt of timely and accurate reporting from contract research organizations ("CROs") and other third-party service providers. To date, there have been no material differences from our accrued expenses to actual expenses.

Income Taxes

Deferred tax assets or liabilities are recorded for temporary differences between financial statement and tax basis of assets and liabilities, using applicable rates in effect for the year in which the differences are expected to reverse. A valuation allowance is recorded if it is more likely than not that a deferred tax asset will not be realized. We have provided a full valuation allowance on our deferred tax assets, which primarily consist of cumulative net operating losses from April 1, 2009 (inception) to March 31, 2020. Due to our history of operating losses since inception and losses expected to be incurred in the foreseeable future, a full valuation allowance was considered necessary.

Impairment of Long-Lived Assets

Management reviews long-lived assets for impairment whenever events or changes in circumstances indicate that the carrying amount may not be realizable or at a minimum annually during the fourth quarter of the year. If an evaluation is required, the estimated future undiscounted cash flows associated with the asset are compared to the asset’s carrying value to determine if an impairment of such asset is necessary. The effect of any impairment would be to expense the difference between the fair value of such asset and its carrying value.

Components of our Results of Operations and Financial Condition

Operating expenses

We classify our operating expenses into three categories: research and development, general and administrative and depreciation.

Research and development. Research and development expenses consist primarily of:

•

costs incurred to conduct research, such as the discovery and development of our current and potential product candidates;

•

costs related to production and storage of clinical supplies, including fees paid to contract manufacturers, manufacturing consultants, and cold-storage facilities;

•

fees paid to clinical consultants, clinical trial sites and vendors, including CROs in conjunction with implementing and monitoring our clinical trials and acquiring and evaluating clinical trial data, including all related fees, such as patient screening fees, laboratory work, and statistical compilation and analysis;

	•	costs related to compliance with drug development regulatory requirements; and
	•	costs related to staffing and personnel associated with research and development activities, including wages, taxes, benefits, leases, overheads, supplies, and share-based compensation.

We recognize all research and development costs as they are incurred. Clinical trial costs, contract manufacturing and other development costs incurred by third parties are expensed as the contracted work is performed.

We expect our research and development expenses to increase in the future as we advance our current and potential product candidates into and through clinical trials, as we expand our clinical programs to a greater number of sites, as we pursue regulatory approval of our current and potential product candidates in the United States and Europe, and as we expand our research programs to include new therapies and new therapy combinations. The process of conducting the necessary clinical research to obtain regulatory approval is costly and time-consuming. The actual probability of success for our current and potential product candidates may be affected by a variety of factors including the quality of our current and potential product candidates, early clinical data, investment in our clinical program, competition, manufacturing capability and commercial viability. We may never succeed in achieving regulatory approval for any of our current and potential product candidates. As a result of the uncertainties discussed above, we are unable to determine the duration and completion costs of our research and development projects or when and to what extent we will generate revenue from the commercialization and sale of our current and potential product candidates.

General and administrative. General and administrative expense consists of personnel related costs, which include salaries, as well as the costs of professional services, such as accounting and legal, travel, facilities, information technology and other administrative expenses. We expect our general and administrative expense to increase in future periods due to the anticipated growth of our business and related infrastructure as well as accounting, insurance, investor relations, and other costs associated with being a public company.

Depreciation. Depreciation expense consists of depreciation from our fixed assets consisting of our property, equipment, and furniture. We depreciate our assets over their estimated useful life. We estimate furniture and computer and office equipment to have a 5-year life.

Results of Operations

Comparison of the Three Months Ended March 31, 2020 and 2019

The following summarizes our results of operations for the three months ended March 31, 2020 and 2019.

Research and Development Expense

Research and development ("R&D") expense was $1,477,877 for the three months ended March 31, 2020 as compared to $508,042 for the three months ended March 31, 2019. The increase of $969,835, or 191%, was due primarily to greater utilization of our employees on R&D activities and further advancements in our preclinical research and clinical and manufacturing programs. These R&D activities will continue throughout 2020 and include costs related to the launch of planned and potential clinical trials for our initial product candidate, the development of manufacturing strategies and manufacturing processes, data analysis, and our preclinical research at MD Anderson.

General and Administrative Expense

General and administrative expense for the three months ended March 31, 2020 was $4,092,996 as compared to $1,659,796 for the three months ended March 31, 2019. The increase of $2,433,200, or 147%, is primarily due to an increase in financing costs and legal fees associated with our fundraising activities for the three months ended March 31, 2020 as well as an increased headcount and additional service providers utilized during the period.

Interest Income. Interest income was $10,006 and $11,923 for the three-month periods ended March 31, 2020 and 2019, respectively, a decrease of $1,917, or 16%. The variations associated with interest income in for the three months ended March 31, 2020 were due to changes in the cash balances associated with money market instruments.

Interest Expense. There was no interest expense for the three-month periods ended March 31, 2020 and 2019. No change in interest expense between the two periods is due to the Company satisfying all debt obligations and repaying short-term loans prior to 2019. As of March 31, 2020, the Company has no outstanding debt.

Depreciation Expense. Depreciation expense was $5,353 and $2,931 for the three months ended March 31, 2020 and 2019, respectively, an increase of $2,422, or 83%. Depreciation is generated from our fixed assets, which currently consists of computer equipment, research and development equipment, and office furniture. The increase in depreciation expense in the period was driven by increased purchases in equipment for use by employees and manufacturing partners for research activities.

Liquidity and Capital Resources

From our inception through March 31, 2020, we have never generated revenue from product sales and have incurred net losses in each year. As of March 31, 2020, we had an accumulated deficit of approximately $46 million. We have funded our operations primarily through the sale and issuance of capital stock. During 2019, we sold 3,167,986 shares of common stock and warrants to purchase 3,167,986 shares of common stock for total gross proceeds of $1,267,194 through a registered direct offering. In the three months ended March 31, 2020, we sold an aggregate of 13,581,000 shares of common stock for total gross proceeds of $25,731,640 through our registered direct offerings.

As of March 31, 2020, we had $23,079,591 in cash.

We do not expect to generate revenue from product sales unless and until we successfully complete development of, obtain regulatory approval for and begin to commercialize one or more of our current and potential product candidates, which we expect will take a number of years and which is subject to significant uncertainty. Accordingly, we anticipate that we will need to raise additional capital to fund our future operations. Until such time as we can generate substantial revenue from product sales, if ever, we expect to finance our operating activities through a combination of equity offerings and debt financings and we may seek to raise additional capital through strategic collaborations. However, we may be unable to raise additional funds or enter into such arrangements when needed on favorable terms, or at all, which would have a negative impact on our financial condition and could force us to delay, limit, reduce or terminate our development programs or commercialization efforts or grant to others rights to develop or market product candidates that we would otherwise prefer to develop and market ourselves. Failure to receive additional funding could cause us to cease operations, in part or in full. Furthermore, even if we believe we have sufficient funds for our current or future operating plans, we may seek additional capital due to favorable market conditions or strategic considerations.

The following table sets forth the primary sources and uses of cash for the three months ended March 31, 2020 and 2019:

	Three Months Ended March 31,
	2020			2019
Net cash used in operating activities	$	(4,517,528	)	$	(1,641,793	)
Net cash used in investing activities		(137,013	)		(13,331	)
Net cash provided by financing activities		25,731,640			—
Net increase (decrease) in cash	$	21,077,099		$	(1,655,124	)

Cash used in operating activities

Net cash used in operating activities was $4,517,528 and $1,641,793 for the three months ended March 31, 2020 and 2019, respectively. The $2,875,735, or 175%, increase in net cash used in operating activities in the three months ended March 31, 2020 was primarily due to an increase in financing costs and legal fees associated with our fundraising activities in the period as well as an increased headcount and additional service providers.

Cash used in investing activities

Net cash used in investing activities was $137,013 and $13,331 for the three months ended March 31, 2020 and 2019, respectively. This increase of $123,682, or 928%, used in investment activities was due to increased spending on property and equipment, intellectual property prosecution, and research and development supplies over the respective periods.

Cash provided by financing activities

Net cash provided by financing activities was $25,731,640 and $0 during the three months ended March 31, 2020 and 2019, respectively. The $25,731,640 increase in net cash provided by financing activities was due to the Company selling common stock during the first three months of 2020.

Item 3. Quantitative and Qualitative Disclosures About Market Risk

The Company is not required to provide the information required by this Item as it is a “smaller reporting company,” as defined in Rule 12b-2 of the Exchange Act.

Item 4. Controls and Procedures.

Disclosure Controls and Procedures

As required by Rules 13a-15(b) and 15d-15(b) of the Exchange Act, our management with the participation of our Chief Executive Officer and our Chief Financial Officer, evaluated the effectiveness of our disclosure controls and procedures as of March 31, 2020. The term “disclosure controls and procedures” as defined in Rules 13a-15(e) and 15d-15(e) under the Exchange Act, means controls and other procedures of a company that are designed to ensure that information required to be disclosed by a company in the reports that it files or submits under the Exchange Act is recorded, processed, summarized and reported, within the time periods specified in the SEC’s rules and forms. Disclosure controls and procedures include, without limitation, controls and procedures designed to ensure that information required to be disclosed by a company in the reports that it files or submits under the Exchange Act is accumulated and communicated to the company’s management, including its principal executive and principal financial officer, as appropriate to allow timely decisions regarding required disclosure. Management recognizes that any controls and procedures, no matter how well designed and operated, can provide only reasonable assurance of achieving their objectives, and management necessarily applies its judgment in evaluating the cost-benefit relationship of possible controls and procedures. Based on the evaluation of our disclosure controls and procedures as of March 31, 2020, our Chief Executive Officer and our Chief Financial Officer concluded that our disclosure controls and procedures were not effective due to the material weakness in our internal control over financial reporting due to the lack of segregation of duties.

In response to the material weakness described above, during the three months ended March 31, 2020, we began evaluating and implementing new internal controls over financial reporting and disclosure controls and procedures. Although management is still evaluating the design of new controls and procedures, we believe that our improved processes and procedures will assist us in remediating our material weakness. Once placed in operation for a sufficient period of time, we will subject these controls and procedures to appropriate tests in order to determine whether they are operating effectively. Management, with oversight from the Audit Committee, is committed to the remediation of our material weakness as expeditiously as possible.

Changes in Internal Control over Financial Reporting

There were no changes in our internal control over financial reporting that occurred during the quarter ended March 31, 2020 that have materially affected, or are reasonably likely to materially affect, our internal control over financial reporting.

Inherent Limitations of Disclosure Controls and Internal Control over Financial Reporting

Because of their inherent limitations, our disclosure controls and procedures and our internal control over financial reporting may not prevent material errors or fraud. A control system, no matter how well conceived and operated, can provide only reasonable, not absolute, assurance that the objectives of the control system are met. The effectiveness of our disclosure controls and procedures and our internal control over financial reporting is subject to risks, including that the controls may become inadequate because of changes in conditions or that the degree of compliance with our policies or procedures may deteriorate.

PART II – OTHER INFORMATION

Item 1. Legal Proceedings

From time to time, we may become involved in various lawsuits and legal proceedings, which arise in the ordinary course of business. Litigation is subject to inherent uncertainties, and an adverse result in these or other matters may arise from time to time that may harm our business. We are currently not aware of any such legal proceedings or claims that will have, individually or in the aggregate, a material adverse effect on our business, financial condition or operating results.

Item 1A. Risk Factors

The Company is not required to provide the information required by this Item as it is a “smaller reporting company,” as defined in Rule 12b-2 of the Exchange Act.

Item 2. Unregistered Sales of Equity Securities and Use of Proceeds.

None.

Item 3. Defaults Upon Senior Securities.

None.

Item 4. Mine Safety Disclosures.

Not applicable.

Item 5. Other Information

None.

Item 6. Exhibits

The exhibits listed on the Index to Exhibits following the signature page are filed as part of this Quarterly Report on Form 10-Q.

INDEX TO EXHIBITS

Exhibit Number		Description of Exhibit
10.1		Form of Securities Purchase Agreement dated January 16, 2020 (Incorporated by reference to Exhibit 10.1 to the Company’s Current Report on Form 8-K filed with the SEC on January 17, 2020).

10.2		Form of Securities Purchase Agreement dated January 23, 2020 (Incorporated by reference to Exhibit 10.1 to the Company’s Current Report on Form 8-K filed with the SEC on January 24, 2020).

10.3		Exclusive License Agreement dated February 11, 2020, by and between the University of Pittsburgh – Of the Commonwealth System of Higher Education and Genprex, Inc. (Incorporated by reference to Exhibit 10.1 to the Company’s Current Report on Form 8-K filed with the SEC on February 18, 2020).

10.4		Form of Securities Purchase Agreement dated February 19, 2020 (Incorporated by reference to Exhibit 10.1 to the Company’s Current Report on Form 8-K filed with the SEC on February 20, 2020).

10.5+		Executive Employment Agreement dated as of March 12, 2020, by and between Genprex, Inc. and Catherine M. Vaczy (Incorporated by reference to Exhibit 10.1 to the Company’s Current Report on Form 8-K filed with the SEC on March 23, 2020).

10.6+		Executive Employment Agreement dated as of March 12, 2020, by and between Genprex, Inc. and Michael T. Redman (Incorporated by reference to Exhibit 10.2 to the Company’s Current Report on Form 8-K filed with the SEC on March 23, 2020).

10.7		Amendment No. 1 to Stock Option Agreement dated as of March 18, 2020, by and between Genprex, Inc. and David E. Friedman (Incorporated by reference to Exhibit 10.1 to the Company’s Current Report on Form 8-K filed with the SEC on March 24, 2020).

10.8		Amendment No. 1 to Stock Option Agreement dated as of March 18, 2020, by and between Genprex, Inc. and Robert W. Pearson (Incorporated by reference to Exhibit 10.2 to the Company’s Current Report on Form 8-K filed with the SEC on March 24, 2020).

10.9*++		Patent and Technology License Agreement dated as of May 4, 2020, by and between Genprex, Inc. and The Board of Regents of The University of Texas System.

31.1*		Certification of Chief Executive Officer pursuant to Rules 13a-14(a) and 15d-14(a) under the Securities Exchange Act of 1934, as adopted pursuant to Section 302 of the Sarbanes-Oxley Act of 2002.

31.2*		Certification of Chief Financial Officer pursuant to Rules 13a-14(a) and 15d-14(a) under the Securities Exchange Act of 1934, as adopted pursuant to Section 302 of the Sarbanes-Oxley Act of 2002.

32.1*		Certifications of Chief Executive Officer and Chief Financial Officer pursuant to 18 U.S.C. Section 1350, as adopted pursuant to Section 906 of the Sarbanes-Oxley Act of 2002.

101.INS*		XBRL Instance document.

101.SCH*		XBRL Taxonomy Extension Schema Document.

101.CAL*		XBRL Taxonomy Extension Calculation Linkbase Document.

101.DEF*		XBRL Taxonomy Extension Definition Linkbase Document.

101.LAB*		XBRL Taxonomy Extension Label Linkbase Document.

101.PRE*		XBRL Taxonomy Extension Presentation Document.

+ Denotes a management contract or compensatory plan.

++ Certain portions of this Exhibit that are not material and would be competitively harmful if publicly disclosed have been redacted pursuant to Item 601(b)(10)(iv) of Regulation S-K.

* Filed herewith.

SIGNATURES

Pursuant to the requirements of the Securities Exchange Act of 1934, as amended, the Registrant has duly caused this report to be signed on its behalf by the undersigned thereunto duly authorized.

	GENPREX, INC.

Date: May 14, 2020	By:	/s/ Rodney Varner
		Rodney Varner
		Chief Executive Officer
		(Principal Executive Officer)

	By:	/s/ Ryan M. Confer
		Ryan M. Confer
		Chief Financial Officer
		(Principal Financial and Accounting Officer)

ex_186626.htm

Exhibit 10.9

[*] Certain information in this document has been omitted from this exhibit because it is both (i) not material and (ii) would be competitively harmful if publicly disclosed.

Patent and Technology License Agreement

This Patent and Technology License Agreement (“Agreement”) is made, effective on the date fully executed by both Parties (the “Effective Date”), by and between The Board of Regents (“Board”) of The University of Texas System (“System”), an agency of the State of Texas, whose address is 210 West 7th Street, Austin, Texas 78701, on behalf of The University of Texas M. D. Anderson Cancer Center (“MD Anderson”), a member institution of System, and Genprex, Inc., having a place of business at Dell Medical School, Health Discovery Building, 1601 Trinity Street, Suite 3.322, Austin, Texas 78712 (“Licensee”). Board and Licensee are each referred to herein as a “Party” and collectively as the “Parties.” In consideration of the mutual covenants and promises herein contained, the Parties agree as follows:

I. Background

1.1 Board owns Licensed IP (defined below).

1.2	Board, through MD Anderson, has determined that development and commercialization of the Licensed IP is in the public’s best interest and is consistent with Board’s educational and research missions and goals.

1.3	Board desires to have the Licensed IP developed and commercialized for the benefit of Licensee, the inventors, Board, System, MD Anderson, and the public.

1.4

Licensee and MD Anderson previously entered into that certain Option Agreement dated February 23, 2017, which was subsequently amended in amendments 1 – 3 thereto (collectively, the “Option Agreement”), and Licensee now desires to secure a license to practice the Licensed IP, as described below in this Agreement.

II. Definitions

As used in this Agreement, the following terms have the meanings indicated:

2.1

Affiliate means any business entity more than fifty percent (50%) owned (directly or indirectly) by Licensee, any business entity which directly or indirectly owns more than fifty percent (50%) of Licensee, or any business entity that is more than fifty percent (50%) owned (directly or indirectly) by a business entity that owns more than fifty percent (50%) of Licensee.

2.2

Asset Sale Transaction means a sale or assignment to a third party of this Agreement and/or all or substantially all of Licensee’s assets to which this Agreement relates.

2.3

Assignment Consideration means the fair market value of any and all consideration, in whatever form, received by Licensee and solely allocable in exchange for any direct or indirect assignment or transfer of this Agreement (other than an assignment or transfer to an Affiliate), including, without limitation, any direct or indirect assignment or transfer resulting from an Asset Sale Transaction, stock sale, merger, restructuring, reorganization or the like. For purposes of the foregoing, an allocation or vesting of the Agreement that occurs as an operation of law (such as, for example, during a merger) shall be considered an “assignment.”

2.4

BLA means (a) a Biologics License Application (as more fully defined in 42 U.S.C. §262(a)(2)(C), 21 C.F.R. 601.2(a), or their successor provisions) seeking Regulatory Approval of a Licensed Product filed with the FDA; or (b) a similar submission to the equivalent applicable regulatory agency in any national jurisdiction other than the United States.

2.5

Change of Control Transaction means a sale to a third party, whether by operation of law or otherwise, in connection with a change of control of Licensee.

2.6

FDA means the United States Food & Drug Administration. Where applicable references to FDA shall include non-United States regulatory authorities that have equivalent responsibilities.

2.7

First Sale means, with respect to a particular Licensed Product, the first Sale of such Licensed Product by or on behalf of Licensee or any Sublicensee, following Regulatory Approval for such Licensed Product.

2.8

Licensed Field means all fields of use.

2.9

Licensed IP means Licensed Patents and Licensed Technology.

2.10

Licensed Patents means the Board’s rights in:

(a)

the patents and patent applications (i) listed in Exhibit A to this Agreement;

(b)

all non-provisional patent applications that claim priority to any of the provisional applications listed in subpart (a) provided that the claims of such non-provisional applications are entitled to claim priority to such provisional applications;

(c)

all divisionals, continuations and continuations-in-part of the non-provisional patent applications identified in (a) and (b), above provided that the claims of such continuations-in-part are entitled to claim priority to at least one of the patent applications identified in (a) or (b), above;

(d)

all reissues, reexaminations, requests for continued examination, substitutions, registrations, revalidations, additions, certificates of correction, renewals, extensions, and foreign counterparts of any of the patents or patent applications identified in (a), (b) or (c), above; and

(e)

any patents that issue with respect to any of the patent applications listed in (a), (b), (c) or (d), above.

2.11

Licensed Products means:

(a)

any product or component that

(i)

comprises, uses, or is made using subject matter covered by one or more Valid Claims;

(ii)

enables a user, acting either alone, independently with other users or in concert with other users, to perform or practice one or more Valid Claims; or

(iii)

incorporates, uses, or is made using Licensed Technology; and/or

(b)

any method or process that, when performed by one or more people and/or entities acting either alone, independently with others or in concert with others

(i) practices one or more Valid Claims, or

(ii) incorporates, uses, or is made using Licensed Technology.

2.12

Licensed Technology means Board’s rights in any technical information, know-how, trade secret, processes, procedures, compositions, devices, methods, formulae, protocols, techniques, designs, drawings or data that:

(a)

were created (i) prior to the Effective Date, (ii) by the inventor(s) listed in MD Anderson Invention Disclosure Report MDA16-100, and (iii) at MD Anderson;

(b) are not covered by a Valid Claim as of the Effective Date;

(c)

facilitate the practice, development, manufacture, use, and/or selling of invention(s) claimed in a Valid Claim as of the Effective Date;

(d)

have no obligations or encumbrances in favor of or benefitting any third party and are not otherwise subject to contractual or legal restrictions that would preclude a license to Licensee under the License Agreement;

(e)

is delivered, provided or otherwise transferred to Licensee; and

(f)

is not publicly available when provided to Genprex; provided, however, in the event Licensed Technology becomes publicly available in a manner inconsistent with Section 10.3, such information shall thereafter no longer be included within Licensed Technology.

2.13

Licensed Territory means worldwide.

2.14

Net Sales means [*]

2.15

Option Agreement shall have the meaning set forth in Article I of this Agreement.

2.16

Patent Expenses means out-of-pocket expenses incurred by MD Anderson in preparing (including conducting prior art searches, if any), filing, prosecuting (including any type of post-grant or post-issuance proceedings), and maintaining patent applications and patents under Licensed Patents.

2.17

Phase I Clinical Trial means: (a) that portion of the FDA submission and approval process which provides for the first introduction into humans of a product with the purpose of determining human toxicity, metabolism, absorption, elimination and other pharmacological action, as more fully defined by the rules and regulations of the FDA, including 21 C.F.R. § 312.21(a) or any future revisions or substitutes therefor; or (b) a similar clinical trial in any national jurisdiction other than the United States. For the avoidance of doubt, the emphasis of a Phase I Clinical Trial is on the safety and tolerability of a product and is used to plan patient dosing in a Phase II Clinical Trial.

2.18

Phase II Clinical Trial means: (a) that portion of the FDA submission and approval process which provides for early controlled clinical studies conducted to obtain preliminary data on the effectiveness of a product for a particular indication, as more specifically defined by the rules and regulations of the FDA, including 21 C.F.R. § 312.21(b) or any future revisions or substitutes therefor; or (b) any clinical trial that obtains data regarding the efficacy of a product, including without limitation Phase Ib clinical trial of a product, a clinical trial of a product consisting of a cohort expansion, or a combined Phase Ib/II clinical trial of a product; or (c) a clinical trial similar to the foregoing (a) or (b) in any jurisdiction other than the United States. For the avoidance of doubt, when the safety and tolerability of a product has been established through the conduct of a Phase I Clinical Trial, the next clinical trial of a product will be a Phase II Clinical Trial.

2.19

Phase III Clinical Trial means: (a) that portion of the FDA submission and approval process in which expanded clinical trials are conducted to gather the additional information about effectiveness and safety that is needed to evaluate the overall benefit-risk relationship of a product, as more specifically defined by the rules and regulations of the FDA, including 21 C.F.R. § 312.21(c) or any future revisions or substitutes therefor; or (b) a similar clinical trial in any national jurisdiction other than the United States.

2.20

Regulatory Approval means the approval needed in a particular country or jurisdiction by a Regulatory Authority to begin marketing and/or sale of a Licensed Product in such country or jurisdiction, which shall include, if applicable, pricing approvals.

2.21

Regulatory Authority means any applicable governmental regulatory authority involved in granting approvals for marketing and/or sale of a Licensed Product, including without limitation, in the United States, the FDA, and any governmental agency or body in any jurisdiction in the Licensed Territory performing such function.

2.22

Research Agreement means the Sponsored Research Agreement between MD Anderson and Licensee effective May 23, 2018, as amended from time-to-time.

2.23

Reseller means a third party wholesaler or distributor that (a) has no significant responsibility for marketing and promotion of a Licensed Product within its distribution territory or field, and (b) does not pay any consideration to Licensee or a Sublicensee for wholesale or distributor rights. For clarity, the Parties agree that as of the Effective Date, Cardinal Health, Amerisource Bergen and McKesson are examples of Resellers with respect to Licensed Products not acquired for end use.

2.24

Sale or Sold means the transfer or disposition of a Licensed Product for value; provided, however, that a transfer or disposition of a Licensed Product for value shall not be included in Sales if the transfer is to Licensee or a Sublicensee that does not acquire such Licensed Product for end use.

2.25

Sublicense Agreement means any agreement or arrangement (other than an assignment of this entire Agreement) pursuant to which Licensee (or a Sublicensee) grants to any third party (other than a Reseller that merely purchases and resells Licensed Products) any of the license rights granted to the Licensee under this Agreement.

2.26

Sublicensee means any entity to whom an express Sublicense Agreement has been granted under the Licensed Patents and/or Licensed Technology. “Sublicensee” does not include a Reseller that merely purchases and resells Licensed Products. For clarity, an Affiliate that makes Sales shall be deemed to be a Sublicensee.

2.27

Sublicensing Consideration means [*]

2.28

Substitutable Generic means a generic FDA-approved drug or biologic that:

(a)

contains the same active ingredients as the Licensed Product sold by Licensee or any Sublicensee(s);

(b) has one or more of the same approved indications as the Licensed Product sold by Licensee or any Sublicensee(s); (a) is bioequivalent to the Licensed Product sold by Licensee or any Sublicensee(s);

(c)

meets the standards for identity, strength, purity and quality as the Licensed Product sold by Licensee or any Sublicensee(s);

(d)

is manufactured under the same standards that FDA requires for the manufacture of brand products; and

(e)

is listed in the Orange Book / Approved Drug Products with Therapeutic Equivalence Evaluations and such listing has an A-rated TE code (e.g., AB).

2.29

Valid Claim means, on a jurisdiction-by-jurisdiction basis, a claim of (a) an issued and unexpired patent included within the Licensed Patents unless the claim has been held unenforceable or invalid by the final, un-reversed, and un-appealable decision of a court or other governmental body of competent jurisdiction, has been irretrievably abandoned or disclaimed, or has otherwise been finally admitted or finally determined by the relevant governmental authority to be invalid, un-patentable or unenforceable, whether through reissue, reexamination, disclaimer or otherwise, or (b) a pending patent application within the Licensed Patents to the extent the claim continues to be prosecuted in good faith for no more than seven (7) years from the earliest priority date thereunder. For clarity, a claim that is prosecuted in good faith for more than seven (7) years and issues thereafter shall be considered a “Valid Claim” as of the date such claim issues.

III. License

3.1	Board, through MD Anderson, hereby grants to Licensee an exclusive, sublicensable, royalty-bearing license under Licensed IP to manufacture, use, commercialize, sell, offer for sale and import any Licensed Product in the Licensed Territory.

This grant is subject to Sections 13.2 and 13.3 hereinbelow, the payment by Licensee to MD Anderson of all consideration as provided herein, and is further subject to the following rights retained by Board and MD Anderson to:

(a)	()Publish the general scientific findings from research related to Licensed IP, subject to the terms of Article X–Confidential Information and Publication; and

(b) ()Use Licensed IP for research, teaching, and other academic non-commercial purposes; and

(c) ()Use Licensed IP for (i) patient care at MD Anderson facilities (x) before first approval of a BLA for a Licensed Product in the United States only with Licensee’s consent, such consent not to be unreasonably withheld, or (y) after first approval of a BLA for a Licensed Product in the United States only if Licensee does not make a Licensed Product commercially available; (ii) internal pre-clinical research; and (iii) teaching, and other non-commercial, academically-related purposes; and

(d) ()Transfer Licensed Technology to academic or research institutions for non-commercial research use.

3.2	Licensee has the right to grant Sublicense Agreements under the Licensed IP consistent with the terms of this Agreement as part of good faith, arms-length transactions, subject to the following:

(a)

A Sublicense Agreement shall not exceed the scope and rights granted to Licensee hereunder. Sublicensee must agree in writing to be bound by terms and conditions materially consistent with this Agreement. In the event of termination of this Agreement, continued sublicense rights shall be governed by Section 3.3. Licensee may grant a Sublicensee the right to grant further sub-Sublicense Agreements consistent with this Agreement, in which case such sub-Sublicense Agreements shall be treated as “Sublicense Agreements” and such sub-Sublicensees shall be treated as “Sublicensees” for purposes of this Agreement.

(b)

Licensee shall deliver to MD Anderson a complete and accurate copy of each Sublicense Agreement granted by Licensee or any Sublicensee, and any modification or termination thereof, within 30 days following the applicable execution, modification, or termination of such Sublicense Agreement. If the Sublicense Agreement is not in English, Licensee shall provide MD Anderson a reasonably accurate English translation in addition to a copy of the original agreement. The Parties agree that inaccuracies in an otherwise reasonably accurate translation shall not be cause for termination of the Agreement.

(c)

Notwithstanding any such Sublicense Agreement, Licensee will remain primarily liable to Board and MD Anderson for all of the Licensee’s duties and obligations contained in this Agreement, including without limitation the payment of running royalties due under Section 4.1(d). Any act or omission of a Sublicensee that would be a breach of this Agreement if performed by Licensee will be deemed to be a breach by Licensee. Each Sublicense Agreement will contain a right of termination by Licensee in the event that the Sublicensee breaches the payment or reporting obligations affecting Board and/or MD Anderson or any other terms and conditions of the Sublicense Agreement that would constitute a material breach of this Agreement if such acts were performed by Licensee.

3.3

All rights and licenses of each Sublicensee shall terminate upon termination of this Agreement, except as expressly agreed by the parties; provided, however, that MD Anderson agrees to negotiate in good faith with each existing Sublicensee that (a) is in good standing under the respective Sublicense Agreement as of the date of termination of this Agreement, and (b) provides written notice to MD Anderson within thirty (30) days after termination of this Agreement stating that such Sublicensee desires to enter into negotiations for an agreement with MD Anderson granting rights under Licensed IP. MD Anderson shall negotiate in good faith in accordance with this Section 3.3 but shall have no obligation to enter into an agreement with any Sublicensee.

3.4	Licensee, itself or through any Sublicensee, shall use commercially reasonable efforts to:

(a)

maintain a bona fide, funded, ongoing and active research, development, manufacturing, regulatory, or marketing program, in each case, consistent with applicable law and Licensee’s use of commercially reasonable efforts;

(b)

make Licensed Products commercially available to the public in the Licensed Field within the Licensed Territory, following Regulatory Approval, and

(c)

achieve the following Diligence Milestone Events by the Deadlines indicated:

Diligence Milestone Events	Deadlines
1. [*]	[*] months from the Effective Date
2. [*]	[*] months from the Effective Date
3. [*]	[*] months from the Effective Date

(d)

If the obligations under Sections 3.4(a)-(c) are not fulfilled Board and/or MD Anderson may treat such failure as a breach, subject to the provisions of Section 12.3(e).

(e)

Not less than thirty days prior to expiry of any of the deadlines for achieving the Diligence Milestones set forth in Section 3.4(c) above, Licensee may extend such deadline(s), up to a maximum of four (4) times, upon written notice to MD Anderson requesting an extension and full payment of the Extension Fee, as defined below prior to expiration of the deadline. For purposes of this Agreement, the term “Extension Fee” shall mean $50,000.00 for each extension request. Upon payment of each Extension Fee with respect to any of the Diligence Milestones, an additional year will be added to the time for completion of such Diligence Milestone and all other as yet unmet Diligence Milestones. It is understood and agreed that time is of the essence with respect to payment of the Extension Fee, and failure to timely pay an Extension Fee shall not be subject to any cure period.

(f)

Within ninety (90) calendar days following each anniversary of the Effective Date, Licensee will deliver to MD Anderson a written progress report as to Licensee's (and any Sublicensee’s) efforts and accomplishments during the preceding year in diligently commercializing Licensed IP in the Licensed Field and Licensed Territory and Licensee's (and Sublicensees') commercialization plans for the upcoming year.

IV. Consideration, Payments and Reports

4.1	In consideration of rights granted by Board to Licensee under this Agreement, Licensee agrees to pay MD Anderson each of the following:

(a)

Patent Expenses. All unreimbursed Patent Expenses incurred by or for MD Anderson before or after the Effective Date for so long as this Agreement remains in effect. MD Anderson will invoice Licensee after the Agreement has been fully executed by all Parties for unreimbursed Patent Expenses incurred as of as of the Effective Date and on a quarterly basis thereafter. The invoiced amounts will be due and payable by Licensee within thirty (30) calendar days of invoice.

(b)

Upfront license fee. A nonrefundable upfront license fee in the amount of $[*]. This upfront licensee fee will not reduce the amount of any other payment provided for in this Article IV, and is due and payable not later than thirty (30) calendar days after the Effective Date. The obligation to timely pay the license upfront fee is not subject to any cure period.

(c)	Annual Maintenance Fees. Nonrefundable annual license maintenance fees (“Annual Maintenance Fees”) as follows:

$[*], escalating by $[*]per year, until First Sale; provided, however, in no event shall an Annual Maintenance Fee exceed $[*]. By way of clarification and not by limitation, the Annual Maintenance Fee due for the second, third, fourth etc. anniversaries of the Agreement shall be $[*], $[*], $[*], etc., up to a maximum of $[*].

The Annual Maintenance Fees will not reduce the amount of any other payment provided for in this Article IV. The Annual Maintenance Fees will be payable within thirty (30) calendar days of each anniversary of the Effective Date.

(d)

Royalties. A running royalty on Net Sales as follows:

(i)

subject to Sections, 4.1(d)(ii)-(v), based on calendar year aggregate worldwide Sales of Licensed Products covered by a Valid Claim, the Royalty Rate set forth in Table 4.1(d)(i):

Table 4.1(d)(i)
Calendar year aggregate worldwide Net Sales of Licensed Products covered by a Valid Claim	Royalty Rate
Portion less than or equal to $[*]	[*]%
Portion greater than $[] but less than or equal to $[]	[*]%
Portion greater than $[] but less than or equal to $[]	[*]%
Portion greater than $[] but less than or equal to $[]	[*]%
Portion exceeding $[*]	[*]%

(i)

No Valid Claim Reduction. In the event that a Licensed Product is not covered at the time of Sale by a Valid Claim in the country or jurisdiction of such Sale, then the Royalty Rate set forth in Table 4.1(d)(i) related to such Sale in such jurisdiction shall be reduced by [*]%. Licensee acknowledges and agrees that the subject matter covered by Licensed Technology not included in a patent application or patent under Licensed Patents is valuable and provides Licensee with a competitive advantage and head start in the further research, development, and commercialization of Licensed Products, and the royalty payments for Licensed Products not covered by a Valid Claim are appropriate in light of the foregoing.

(ii)

Third Party Payments. In the event that Licensee obtaining a license to third-party intellectual property rights in a particular jurisdiction is reasonably necessary to avoid a claim of infringement due to Licensee’s exercise of its rights hereunder, and Licensee enters into such a license, then up to [*]% of the royalties payable and actually paid to such third party for such license in such jurisdiction may be deducted from royalties otherwise due MD Anderson under Section 4.1(d)(i); provided, however, in no event shall the royalties payable to MD Anderson pursuant to this provision in any one-year period be reduced to less than [*]% of the royalties otherwise due.

(iii)

Third-Party Competition Reduction. If Licensee provides evidence to MD Anderson that Licensee has substantial direct competition from a party other than a Sublicensee who is selling a Substitutable Generic in the jurisdiction of Sale and the Licensed Product being Sold by Licensee in said jurisdiction is not covered by a Valid Claim in said jurisdiction, then the royalties otherwise due MD Anderson under Section 4.1(d)(i) for Sales in such jurisdiction may be reduced to [*]% only during the period(s) for which Licensee can show such evidence of such substantial direct competition.

(iv)

Mechanics. Notwithstanding anything to the contrary herein, in no event shall the reductions set forth in subsections (ii) and (iii), individually or in the aggregate, reduce the royalties under Section 4.1(d) to less than [*]% of the royalties otherwise payable to MD Anderson if no such reductions were applied.

(e)

Minimum Annual Royalties. After the first Sale, minimum annual royalties (“Minimum Annual Royalties”) of $[*], due and payable (without invoice) within thirty (30) calendar days of the first and each subsequent anniversary of the Effective Date which follows the first Sale; provided, however, that in the event that there is less than a twelve (12) month period between the first Sale, and the first anniversary of the Effective Date which follows the first Sale, then Licensee shall pay the following:

(1) the Annual Maintenance Fee due for that year multiplied by the fraction A/C, where A is the number of months between the anniversary of the Effective Date preceding the first Sale and the first Sale, and C is twelve (12); and

(2) the Minimum Annual Royalties multiplied by the fraction B/C, where B is the number of months between the first Sale and the first anniversary of the Effective Date which follows the first Sale, C is twelve (12), and A + B = twelve (12).

Running royalties accrued under Section 4.1(d) and paid to MD Anderson during the one year period preceding an anniversary of the Effective Date shall be credited against the Minimum Annual Royalties due on that anniversary date.

(f)

The following Milestone Payments are payable for each occurrence of each Milestone Event as set forth in Table 4.1(f), regardless of whether the milestone is achieved by Licensee, a Sublicensee or Affiliate:

Table 4.1(f)
Milestone Event	Milestone Payment
1. [*]	[] Dollars ($[])
2. [*]	[] Dollars ($[])
3. [*]	[] Dollars ($[])
4. [*]	[] Dollars ($[])
5. [*]	[] Dollars ($[])

For clarity, Milestone Event No. 5 shall be payable if the jurisdiction of the second Regulatory Approval of the Licensed Product is the same as, or different from, the jurisdiction of the first Regulatory Approval of such Licensed Product. Milestone Payments related to the foregoing Milestone Events are payable one-time on a Licensed Product-by-Licensed Product basis.

(g)

Sublicensing Consideration. Licensee shall pay MD Anderson the highest applicable percentage of Sublicensing Consideration within thirty (30) calendar days of receipt thereof as set forth in Table 4.1(g):

Table 4.1(g)
Sublicense Agreement effective date	Percentage of Sublicensing Consideration due MD Anderson
Prior to achievement of Milestone Event 1 for any Licensed Product	[] Percent ([]%)
After achievement of Milestone Event 1 but Prior to achievement of Milestone Event 2 for such Licensed Product	[*])
After achievement of Milestone Event 2 for such Licensed Product	([*]%)

(h)

Assignment Consideration.

(i)

Subject to Section 4.1(h)(ii), in connection with any Change of Control Transaction or in connection with any Asset Sale Transaction, Licensee shall pay MD Anderson a fee (an “Assignment Fee”) equal to the applicable percentage of Assignment Consideration, as set forth in Table 4.1(h), as determined at the Closing Date of such transaction, within thirty (30) calendar days of Licensee’s (or its shareholders’, designees’, successors’ or assigns’, as applicable) receipt thereof; provided, however, in the event of a Change of Control Transaction, the result of which Licensee retains direct control and exercise of the rights granted in Article III (each, an “Excluded Transaction”), payment of such Assignment Fee shall be due within thirty (30) days of the Closing Date of the first Change of Control Transaction or Asset Sale Transaction thereafter for which payment may not be delayed under this Section 4.1(h)(i) (a “Triggering Transaction”).

Table 4.1(h)
Closing Date of Transaction	Percentage of Assignment Consideration due MD Anderson	Maximum Assignment Fee to be paid to MD Anderson
Prior to achievement of Milestone Event 1 for any Licensed Product	[*]%	$[*]
After achievement of Milestone Event 1, but before achievement of Milestone Event 2	[*]%	$[*]
After achievement of Milestone Event 2, but before achievement of Milestone Event 3	[*]%	$[*]
After achievement of Milestone Event 3, but before achievement of Milestone Event 4	[*]%	$[*]
After achievement of Milestone Event 4	[*]%	$[*]

(ii)

upon the occurrence of any Excluded Transaction, Licensee shall promptly provide written notice to MD Anderson setting forth the material terms of such transaction and the fair market value (at the time of such transaction) of any and all consideration, in whatever form, received by Licensee and solely allocable to this Agreement related to such transaction. For clarity, 1) the parties agree that a transaction where “Company X” merges Licensee out of existence at a point in time after an Excluded Transaction would be a Triggering Transaction; 2) the Assignment Fee owed for such Triggering Transaction will be based on the Table 4.1(h) percentage applicable at the Closing Date of the Triggering Transaction; and 3) the Assignment Fee owed for an Excluded Transaction will be based on the Table 4.1(h) percentage applicable at the Closing Date of the Excluded Transaction.

4.2

Unless otherwise provided, all such payments are payable within forty-five (45) calendar days after March 31, June 30, September 30, and December 31 of each year during the term of this Agreement, at which time Licensee will also deliver to MD Anderson a true and accurate report, giving such particulars of the business conducted by Licensee and any Sublicensee, if any exist, during the preceding three (3) calendar months under this Agreement as necessary for MD Anderson to account for Licensee's payments hereunder. This report will include pertinent data, including, but not limited to each of the following:

(a)

The accounting methodologies used to account for and calculate the items included in the report and any differences in such accounting methodologies used by Licensee since the previous report.

(b)

A list of Licensed Products produced for the three (3) preceding calendar months categorized by the technology it relates to under Licensed Patents.

(c)

The total quantities of Licensed Products produced by the category listed in Section 4.2(b).

(d)

()The total Sales by the category listed in Section 4.2(b).

(e)

()The calculation of Net Sales by the category listed in Section 4.2(b).

(f)

()Net Sales segregated on a product-by-product and service-by service basis, or an affirmative statement that no Sales were made. The report shall also itemize the permitted deductions from the gross consideration from a Sale used to arrive at the resulting Net Sales, on a product-by-product and service-by service basis.

(g)

()The royalties so computed and due MD Anderson by the category listed in Section 4.2(b).

(h)

()All consideration received from each Sublicensee or assignee and payments due MD Anderson.

(i)

()All other amounts due MD Anderson herein.

Simultaneously with the delivery of each such report, Licensee agrees to pay MD Anderson the amount due, if any, for the period of such report. These reports are required even if no payments are due.

4.3

During the term of this Agreement and for one (1) year thereafter, Licensee agrees to keep complete and accurate records of its, and any Sublicensees', Sales and Net Sales in sufficient detail to enable the royalties and other payments due hereunder to be determined. Licensee agrees to permit MD Anderson or its representatives, at MD Anderson's expense, to periodically examine Licensee’s books, ledgers, and records during regular business hours and upon reasonable prior notice for the purpose of and to the extent necessary to verify any report required under this Agreement. If any amounts due MD Anderson are determined to have been underpaid in an amount equal to or greater than five percent (5%) of the total amount due during the period so examined, then Licensee will pay the cost of the examination. Licensee shall pay accrued interest at one percent (1%) per month, or if higher than the highest rate allowed by applicable law, then the highest rate allowed by applicable law on any and all late payments under this Agreement (regardless of whether the deficiency is identified by audit or otherwise), with such interest commencing on the date after the due date.

4.4

All amounts payable hereunder by Licensee shall be made in United States Dollar denominated funds, free and clear and without any deduction, set-off, or reduction for or on account of any tax, levy, impost, duty, charge, fee or withholding of any nature (“Tax”), unless such Tax is required by applicable law. Licensee shall deduct and withhold from the payments any Tax that it is required by applicable law to deduct or withhold on behalf of Board and/or MD Anderson. Notwithstanding the foregoing, if Board and/or MD Anderson is entitled under any applicable tax treaty to a reduction of rate of, or the elimination of, or recovery of, applicable withholding tax, it may deliver to Licensee or the appropriate governmental authority the prescribed forms necessary to reduce the applicable rate of withholding or to relieve Licensee of its obligation to withhold tax. In such case Licensee shall apply the reduced rate of withholding, or not withhold, as the case may be, provided that Licensee is in receipt of documentation supporting such reduced rate of withholding at least two (2) weeks prior to the time that the payments are due under this Agreement. If, in accordance with the foregoing, Licensee withholds any amount, Licensee shall (i) pay to MD Anderson the balance when due, (ii) make timely payment to the proper taxing authority of the withheld amount, and (iii) send MD Anderson proof of such payment within sixty (60) days following that payment. Licensee shall provide MD Anderson with reasonable advance written notice (and in any event not less than thirty (30) days) of any contemplated deduction or withholding, identifying the relevant taxing jurisdiction and nature of the contemplated payment, and confer in good faith with MD Anderson regarding any preferential treatment that may be allowed to reduce or eliminate such deduction or withholding.

4.4	Payments shall be by checks made payable to The University of Texas M. D. Anderson Cancer Center, and sent by United States mail to Box 4390, Houston, Texas 77210-4390, or by wire transfer to:

[*]

4.5	No payments due or royalty rates owed under this Agreement will be reduced as the result of co-ownership of Licensed IP by Board and another party, including, but not limited to, Licensee.

4.6

If payment requires delivery of an invoice, then MD Anderson’s delay in providing an invoice shall not excuse or waive any payment obligation of Licensee, but the deadline for Licensee’s payment shall be extended by the period of such delay. Any failure by Licensee to update its billing address shall not excuse timely payment.

V. Patents and Inventions

5.1

If after consultation with Licensee both Parties agree that a new patent application should be filed for Licensed IP, MD Anderson will prepare and file appropriate patent applications, and Licensee will pay the related Patent Expenses in accordance with Section 4.1(a). If Licensee notifies MD Anderson that it does not intend to pay any portion of the Patent Expenses, or if Licensee fails to promptly confirm its intent to pay any portion of the Patent Expenses upon inquiry from MD Anderson, or if Licensee is in arrears or otherwise in default or late on any payments due under Section 4.1, or if Licensee fails to timely make any payments for Anticipated Costs when due under Section 5.5, then MD Anderson may, in its sole discretion, elect to file, not file, continue prosecution or maintenance, or abandon patent application or patent related to such Patent Expenses at its own expense without further notice to Licensee. In the event MD Anderson files or continues prosecution or maintenance of such patent application or patent at MD Anderson’s expense, then Licensee’s rights to such patent or patent application otherwise within the scope of Licensed Patents shall terminate in their entirety upon written notice from MD Anderson.

5.2

If at any time Licensee wishes to cease paying Patent Expenses for a particular patent or patent application included in Licensed Patents, Licensee must give MD Anderson at least ninety (90) days prior written notice and Licensee will continue to be obligated to pay for the Patent Expenses which reasonably accrue with respect thereto during said notice period. Thereafter, said particular patent application or patent shall no longer be included in the Licensed Patents and Licensee shall have no further rights thereto.

5.3	Licensee shall cooperate with MD Anderson in (a) determining the appropriate entity size status applicable to Licensed Patents for purposes of the regulations of the U.S. Patent and Trademark Office, and (b) in satisfying patent deadlines imposed by applicable law, including the Bayh Dole Act.

5.4

MD Anderson will provide Licensee with a copy of any Licensed Patent for which Licensee has paid the cost of filing, as well as copies of any documents received or filed during prosecution thereof. The Parties agree that they share a common legal interest to get valid enforceable patents and that Licensee will keep all privileged information received pursuant to this Section confidential.

5.5

Notwithstanding Section 4.1(a), prior to instructing patent counsel to respond or take action with respect to Licensed Patents and/or prior to incurring costs with respect thereto, MD Anderson shall have the right, at its election and in its sole discretion, to require upfront, advance payment from Licensee of the anticipated Patent Expenses for any patent or patent application directed to Licensed Patents (“Anticipated Costs”) as follows: MD Anderson shall provide a reasonable estimate of the Anticipated Costs to Licensee and shall specify a due date for the advance payment of such Anticipated Costs. With respect to such due date, MD Anderson may require Licensee to make such advance payment for Anticipated Costs at any time up to two (2) months prior to the date MD Anderson has chosen for the legal work to be completed, provided that such due date for payment is at least fifteen (15) days after the estimate is provided to Licensee. Unless otherwise agreed in writing, such estimate may be sent by email in accordance with the Notice provisions in Section 14.2. In the event the payment for Anticipated Costs actually made by Licensee to MD Anderson exceeds the actual costs, any unused balance will be credited towards future Patent Expenses, or, upon written request, returned to Licensee. In the event the actual costs incurred by MD Anderson exceed the estimate of Anticipated Costs, MD Anderson shall invoice Licensee for the excess costs. Within thirty (30) days of receiving an invoice from MD Anderson for such costs incurred in excess of the reasonable estimate of Anticipated Costs, Licensee shall reimburse MD Anderson for such excess amount.

5.6

If Licensee is more than forty-five (45) days in arrears on any payment or obligation due under this Agreement, Board, MD Anderson, and the counsel prosecuting Licensed Patents shall have no obligation to confer or otherwise communicate with, or provide any information to, Licensee under this Article V of this Agreement unless and until Licensee is no longer in arrears on all payments and obligations under this Agreement.

VI. Infringement by Third Parties

6.1

Licensee, at its expense, has the first right to enforce and, to the extent authorized by the Texas Constitution and the laws of the State of Texas and subject to the statutory duties of the Texas Attorney General, defend any patent exclusively licensed hereunder against infringement by third parties in the Licensed Field within the Licensed Territory. If Licensee chooses to enforce or defend such patents, then MD Anderson shall cooperate with Licensee in connection with such enforcement or defense. In any suit or dispute against an infringer of patents licensed hereunder, at the request and expense of the party bringing suit, the other party will permit reasonable access, during regular business hours, to relevant records, papers, information, samples, specimens, and the like in its possession, if and only to the extent that such materials or information are not protected by a privilege or immunity of such other party or a privacy or confidentiality right of any third person. Board and MD Anderson shall have reasonable prior input on choice of counsel on any matter where such counsel represents Board or MD Anderson, and Licensee and such counsel agree to follow all required procedures of the Texas Attorney General regarding retention of outside counsel for state entities. Licensee shall be responsible for payment of all fees and expenses associated with such enforcement incurred by Licensee and incurred by MD Anderson in providing cooperation in such enforcement. Any recovery for actual damages or punitive or enhanced damages in excess of Licensee’s documented, third-party expenses in enforcing the Licensed Patents and amounts actually reimbursed by Licensee to MD Anderson under this Section 6.1 shall be shared by Licensee with MD Anderson as follows: (A) for punitive and enhanced damages, [*]% of such recovery shall be provided to MD Anderson and [*]% shall be retained by Licensee; and (B) for all other damages, [*]% of such recovery shall be provided to MD Anderson and [*]% shall be retained by Licensee. Licensee must notify MD Anderson in writing of any substantial, potential infringement in the Licensed Field within the Licensed Territory within thirty (30) calendar days of knowledge, as evidenced in writing, thereof. If Licensee does not file suit against a substantial infringer in the Licensed Field within the Licensed Territory within six (6) months of knowledge thereof, then Board or MD Anderson may, at its sole discretion, enforce any patent licensed hereunder on behalf of itself and Licensee, with MD Anderson retaining all recoveries from such enforcement and paying all fees and costs related thereto.

VII. Patent Marking

7.1

Licensee agrees that all packaging containing individual Licensed Product(s), documentation therefor, and, when possible, actual Licensed Product(s) sold by Licensee and/or Sublicensees of Licensee will be appropriately marked with the number of any applicable patent(s) licensed hereunder in accordance with each country's patent laws, including Title 35, United States Code, to the extent such marking is necessary or required to fully preserve Licensed Patents in each such country or the right to recover damages for infringement thereof.

VIII. Indemnification and Insurance

8.1

LICENSEE AGREES TO HOLD HARMLESS AND INDEMNIFY BOARD, SYSTEM, MD ANDERSON, THEIR REGENTS, OFFICERS, EMPLOYEES, STUDENTS AND AGENTS (THE “UT INDEMNITEES”) FROM AND AGAINST ANY CLAIMS, DEMANDS, OR CAUSES OF ACTION WHATSOEVER, COSTS OF SUIT AND REASONABLE ATTORNEY’S FEES (INCLUDING WITHOUT LIMITATION, THOSE COSTS ARISING ON ACCOUNT OF ANY INJURY OR DEATH OF PERSONS OR DAMAGE TO PROPERTY) CAUSED BY, OR ARISING OUT OF, OR RESULTING FROM, THE EXERCISE OR PRACTICE BY LICENSEE, ITS OFFICERS, ANY SUBLICENSEE OR THEIR OFFICERS, EMPLOYEES, AGENTS OR REPRESENTATIVES OF THE RIGHTS GRANTED HEREUNDER.

8.2

IN NO EVENT SHALL BOARD, SYSTEM, MD ANDERSON OR LICENSEE BE LIABLE FOR ANY INDIRECT, SPECIAL, CONSEQUENTIAL OR PUNITIVE DAMAGES (INCLUDING, WITHOUT LIMITATION, DAMAGES FOR LOSS OF PROFITS OR EXPECTED SAVINGS OR OTHER ECONOMIC LOSSES, OR FOR INJURY TO PERSONS OR PROPERTY) ARISING OUT OF, OR IN CONNECTION WITH, THIS AGREEMENT OR ITS SUBJECT MATTER, REGARDLESS OF WHETHER BOARD, SYSTEM, MD ANDERSON OR LICENSEE KNOWS OR SHOULD KNOW OF THE POSSIBILITY OF SUCH DAMAGES, EXCEPT TO THE EXTENT THAT SUCH DAMAGES WERE CAUSED BY BOARD’S, SYSTEM’S, MD ANDERSON’S OR LICENSEE’S (AS THE CASE MAY BE) GROSS NEGLIGENCE, WILLFUL MISCONDUCT OR FRAUD.

8.3

SCOPE OF INDEMNIFICATION OF UT INDEMNITEES.

LICENSEE’S OBLIGATIONS TO HOLD HARMLESS AND INDEMNIFY THE UT INDEMNITEES IN SECTION 8.1 AND THE LIMITATION OF LIABILITY IN SECTION 8.2 SHALL INCLUDE, BUT ARE NOT LIMITED TO, ANY CLAIM ALLEGING STRICT STATUTORY LIABILITY, PRODUCT DEFECT LIABILITY, OR ANY UT INDEMNITEE’S OWN NEGLIGENCE (WHETHER SOLE OR CONCURRENT) THAT ARISES OUT OF, RELATES TO, IS CAUSED IN WHOLE OR IN PART BY, OR RESULTS FROM THE USE OR SALE OF ANY TANGIBLE MATERIALS (INCLUDING BIOLOGICAL MATERIALS) PROVIDED TO LICENSEE BY BOARD OR MD ANDERSON UNDER OR IN CONNECTION WITH THIS AGREEMENT OR PRODUCTS USED OR SOLD BY LICENSEE OR ANY SUBLICENSEE.

8.4

Beginning at the time when any Licensed IP or any Licensed Product is being distributed or sold (including for the purpose of obtaining regulatory approvals) by Licensee or by a Sublicensee, Licensee shall, at its sole cost and expense, procure and maintain commercial general liability insurance in amounts not less than $[*] per incident and $[*] annual aggregate, and Licensee shall use reasonable efforts to have the UT Indemnitees named as additional insureds. Such commercial general liability insurance shall provide: (i) product liability coverage; (ii) broad form contractual liability coverage for Licensee's indemnification under this Agreement; and (iii) coverage for litigation costs. The minimum amounts of insurance coverage required herein shall not be construed to create a limit of Licensee's liability with respect to its indemnification under this Agreement.

8.5

Licensee shall provide MD Anderson with written evidence of such insurance within thirty (30) calendar days of its procurement. Additionally, Licensee shall provide MD Anderson with written notice of at least fifteen (15) calendar days prior to the cancellation, non-renewal or material change in such insurance.

8.6

Licensee shall maintain such commercial general liability insurance beyond the expiration or termination of this Agreement during: (i) the period that any Licensed Products are being commercially distributed or sold by Licensee or by a Sublicensee, Reseller, or other agent of Licensee; and (ii) the five (5) year period immediately after such period.

IX. Use of Name

9.1	Licensee will not use the name of (or the name of any employee of) MD Anderson, System or Board in any advertising, promotional or sales literature, on its Web site, or for the purpose of raising capital without the advance written consent of Board secured through:

The University of Texas

M. D. Anderson Cancer Center

Strategic Industry Ventures/Office of Technology Commercialization

Unit 1669

P.O. Box 301407

Houston, Texas 77230-1407

With a copy, which shall not constitute notice, to:

The University of Texas

M.D. Anderson Cancer Center

Legal Services, Unit 1674

P.O. Box 301407

Houston, TX 77230-1407

Notwithstanding the above, Licensee may use the name of (or name of employee of) MD Anderson, System or Board in routine business correspondence, or as needed in appropriate regulatory submissions without written consent.

X. Confidential Information and Publication

10.1

MD Anderson and Licensee each agree that all information contained in documents marked “confidential” and forwarded to one by the other (i) are to be received in strict confidence, (ii) are to be used only for the purposes of this Agreement, and (iii) will not be disclosed by the recipient Party, its agents or employees without the prior written consent of the disclosing Party, except to the extent that the recipient Party can establish by competent written proof that such information:

(a)

is or becomes publicly available through actions of persons or entities other than the receiving Party or its representative;

(b)

is obtained by the receiving Party from a third party who is under no obligation of confidentiality with respect thereto and who is authorized to disclose such information on a non-confidential basis to the receiving Party;

(c)

was in the possession of the receiving Party prior to disclosure thereto by the disclosing Party, and was not acquired, directly or indirectly, from the disclosing Party, as evidenced by the records of the receiving Party; or

(d)

is independently developed by the receiving Party without any use of the disclosing Party’s confidential information, as evidenced by the records of the receiving Party.

10.2

Each Party’s obligation of confidence hereunder will be fulfilled by using at least the same degree of care with the disclosing Party's confidential information as it uses to protect its own confidential information, but always at least a reasonable degree of care. This obligation will exist while this Agreement is in force and for a period of three (3) years thereafter.

10.3

MD Anderson reserves the right to publish the general scientific findings from research related to Licensed IP, with due regard to the protection of Licensee’s confidential information. MD Anderson will submit the manuscript of any proposed publication to Licensee at least thirty (30) calendar days before publication, and Licensee shall have the right to review and comment upon the publication in order to protect Licensee’s confidential information. Upon Licensee’s request, publication may be delayed up to sixty (60) additional calendar days to enable Licensee to secure adequate intellectual property protection of Licensee’s confidential information that would otherwise be affected by the publication.

10.4

In the event that the recipient Party is required to disclose the disclosing Party’s confidential information under operation of applicable law, regulation, or order of a court or governmental administrative body having competent jurisdiction, the recipient Party shall, to the extent practicable, provide the disclosing Party reasonable notice of such potential disclosure so that that the disclosing Party may seek a protective order or other appropriate protection or legal relief to prevent or limit such disclosure. If, in the absence of, or pursuant to the terms of, such protection or legal relief, the recipient Party is nonetheless required by applicable law, regulation, or order of a court or governmental administrative body having competent jurisdiction to disclose any portion of the disclosing Party’s confidential information, the required disclosure shall be permitted under this Agreement but shall be limited to only that portion of the disclosing Party’s confidential information for which disclosure is so required.

XI. Assignment

11.1

Except in connection with a sale of all or substantially all of Licensee's assets to which this Agreement relates to a third party or a sale to a third party by operation of law in connection with a change of control of Licensee, this Agreement may not be assigned by Licensee without the prior written consent of MD Anderson, which will not be unreasonably withheld. Any attempted assignment in violation of the foregoing shall be null and void. For any assignment or transfer of this Agreement to be effective, (a) the Licensee must timely pay MD Anderson an Assignment Fee pursuant to Section 4.1(h) and (b) the assignee must assume in writing (a copy of which writing will be provided to MD Anderson) all of Licensee's interests, rights, duties, and obligations under the Agreement and agree to comply with all terms and conditions of the Agreement as if the assignee were the original Party (i.e., the Licensee) to the Agreement. Without limiting the generality of the foregoing and for the avoidance of doubt, Licensee shall not engage in any assignment or transfer of this Agreement for the purpose of, or having the effect of, avoiding payment of an Assignment Fee or circumventing MD Anderson’s consent where the same would otherwise be required, including, without limitation, performing a first transaction that results in Licensee becoming an entity within a third-party organization and subsequently performing a second transaction that assigns the Agreement to such third-party organization.

XII. Term and Termination

12.1

Subject to Sections 12.2, 12.3 and 12.4 hereinbelow, the term of this Agreement is from the Effective Date until the last to occur of: (a) the expiration of all patents issued under Licensed Patents (if any) and the cancellation, withdrawal, or express abandonment of all patent applications under Licensed Patents (if any), or (b) the date that is the thirtieth (30^th) anniversary of the Effective Date.

12.2	[Reserved.]

12.3	Subject to any rights or obligations herein which survive termination, this Agreement will earlier terminate in its entirety:

(a)

upon ninety (90) prior written notice from Licensee to MD Anderson;

(b)

automatically, if Licensee becomes bankrupt or insolvent and/or if the business of Licensee shall be placed in the hands of a receiver, assignee for the benefit of creditors, or trustee, whether by voluntary act of Licensee or otherwise;

(c)

upon thirty (30) calendar days written notice from MD Anderson, if Licensee breaches or defaults on the payment or report obligations of Article IV (excluding the upfront license fee specified in Section 4.1(b), for which no cure period applies), or use of name obligations of Article IX, unless, before the end of such thirty (30) calendar day notice period, Licensee has cured the default or breach to MD Anderson’s reasonable satisfaction, and so notifies MD Anderson, stating the manner of the cure;

(d)

immediately, upon written notice from MD Anderson, if Licensee fails to timely pay the license upfront fee specified in Section 4.1(b);

(e)

upon ninety (90) calendar days written notice from MD Anderson if Licensee breaches or defaults on any other obligation under this Agreement, unless, before the end of such ninety (90) calendar-day notice period, Licensee has cured the default or breach to MD Anderson’s reasonable satisfaction and so notifies MD Anderson, stating the manner of the cure;

(f)

subject to the terms of the fully-executed Research Agreement, upon thirty (30) calendar days written notice from MD Anderson, if Licensee has not, within two (2) years of the Effective Date provided to MD Anderson at least $2,030,000.00 in total under the Research Agreement (including sums paid before the Effective Date), unless before the end of such thirty (30) calendar day notice period, Licensee has cured such underpayment; or

(g)

if Section 14.9 is invoked.

12.4 Upon termination of this Agreement:

(a)

nothing herein will be construed to release either Party of any obligation maturing prior to the effective date of the termination; and

(b)

Licensee covenants and agrees to remain bound by the provisions of Articles VIII (Indemnification and Insurance), IX (Use of Board and MD Anderson’s Name) and X (Confidential Information and Publication) of this Agreement.

(c)

Licensee agrees to cease and desist any use and Sale of products covered by Licensed Patents and/or incorporating, using, or made using Licensed Technology that is not publicly available as of the effective date of termination; provided, however, Licensee may sell products in the Licensed Territory that are not covered by Licensed Patents and do not incorporate, use, or are made using Licensed Technology that is not publicly available as of the effective date of termination.

XIII. Warranty: Superior-Rights

13.1	Except for the rights, if any, of the Government of the United States of America (“Government”) as set forth below, Board represents and warrants its belief that (a) it is the owner of the right, title, and interest in and to Licensed IP, and (b) it has the right to grant licenses thereunder.

13.2

Licensee understands that the Licensed IP may have been developed under a funding agreement with the Government and, if so, that the Government may have certain rights relative thereto. This Agreement is explicitly made subject to the Government's rights under any such agreement and any applicable law or regulation. To the extent that there is a conflict between any such agreement, applicable law or regulation and this Agreement, the terms of such Government agreement, applicable law or regulation shall prevail.

13.3

LICENSEE UNDERSTANDS AND AGREES THAT BOARD AND MD ANDERSON, BY THIS AGREEMENT, MAKE NO REPRESENTATION AS TO THE OPERABILITY OR FITNESS FOR ANY USE, SAFETY, EFFICACY, APPROVABILITY BY REGULATORY AUTHORITIES, TIME AND COST OF DEVELOPMENT, PATENTABILITY, AND/OR BREADTH OF THE LICENSED IP. BOARD AND MD ANDERSON, BY THIS AGREEMENT, ALSO MAKE NO REPRESENTATION AS TO WHETHER ANY PATENT COVERED BY LICENSED PATENTS IS VALID OR AS TO WHETHER THERE ARE ANY PATENTS (OTHER THAN THE LICENSED PATENTS) NOW HELD, OR WHICH WILL BE HELD, BY OTHERS OR BY BOARD OR MD ANDERSON IN THE LICENSED FIELD. NEITHER BOARD NOR MD ANDERSON MAKES ANY REPRESENTATION THAT THE PRACTICE OF LICENSED IP OR LICENSED PRODUCTS DOES NOT INFRINGE ANY PATENTS (OTHER THAN LICENSED PATENTS) NOW HELD OR THAT WILL BE HELD BY OTHERS OR BY BOARD.

13.4

Licensee, by execution hereof, acknowledges, covenants and agrees that Licensee has not been induced in any way by Board, System, MD Anderson or employees thereof to enter into this Agreement, and further warrants and represents that (a) Licensee is entering into this Agreement voluntarily; (b) Licensee has conducted sufficient due diligence with respect to all items and issues pertaining to this Agreement; and (c) Licensee has adequate knowledge and expertise, or has used knowledgeable and expert consultants, to adequately conduct such due diligence, and agrees to accept all risks inherent herein.

XIV. General

14.1

This Agreement, and all claims arising out of or relating thereto, together with any exhibits and/or fully executed amendments hereto, constitutes the entire and only agreement between the Parties for licensure of Licensed IP and all other prior negotiations, representations, agreements and understandings related thereto are superseded hereby. Neither Party has relied on any such prior communication in entering into this Agreement. No agreements altering or supplementing the terms hereof will be made except by a written document signed by both Parties.

14.2

Any notice required by this Agreement shall be in writing and shall be deemed to have been sufficiently given for all purposes thereof when sent by first class mail or reputable international courier (e.g., Federal Express or UPS) and shall be evidenced by the postmark at the point of mailing or by the dated delivery receipt of the courier. All notices and any correspondence respecting this Agreement shall be transmitted as follows:

To MD Anderson, if by mail:

The University of Texas M. D. Anderson Cancer Center

Strategic Industry Ventures/Office of Technology Commercialization

Unit 1669

P.O. Box 301407

Houston, Texas 77230-1407

To MD Anderson, if by courier:

The University of Texas M. D. Anderson Cancer Center

Strategic Industry Ventures/Office of Technology Commercialization

1MC9.2216

7007 Bertner Avenue

Houston, Texas 77030-3907

To Licensee by mail or courier:

Genprex, Inc.

Dell Medical School, Health Discovery Building

1601 Trinity Street, Suite 3.322

Austin, Texas 78712

Attention: Rodney Varner

or other addresses as may be given from time to time under the terms of this notice provision.

Communications regarding patent prosecution may be transmitted by electronic mail. For such communications to MD Anderson sent via electronic mail, the electronic mail shall be addressed or copied to patentmail@mdanderson.org. For such communications to Licensee sent via electronic mail, the electronic mail shall be addressed or copied to rvarner@genprex.com, with a copy to rconfer@genprex.com.

Communications transmitting invoices to Licensee may be transmitted by email sent to rvarner@genprex.com, with a copy to rconfer@genprex.com.

14.3

Licensee and MD Anderson each represent and warrant to the other that it will comply with all applicable statutes, laws, ordinances and regulations relating to their activities under this Agreement, including, without limitation, those enforced by the FDA (including with respect to Licensee, compliance with cGMPs) and applicable export control laws.

14.4

This Agreement and all claims arising out of or relating thereto will be governed, construed and enforced in accordance with the laws of the United States of America and of the State of Texas, without regard to its conflict of law provisions. The Texas State Courts of Harris County, Texas (or, if there is exclusive federal jurisdiction, the United States District Court for the Southern District of Texas) shall have exclusive jurisdiction and venue over any dispute arising out of this Agreement, and Licensee consents to the jurisdiction and venue of such courts and hereby explicitly waives the rights to any other venue to which it might be entitled by cause of action, domicile or otherwise.

14.5	[Reserved]

14.6	Failure of Board or MD Anderson to enforce a right under this Agreement will not act as a waiver of right or the ability to later assert that right relative to the particular situation involved.

14.7

Headings included herein are for convenience only and will not be used to construe this Agreement. The Parties acknowledge and agree that both Parties substantially participated in negotiating the provisions of this Agreement; therefore, both Parties agree that any ambiguity in this Agreement shall not be construed more favorably toward one Party than the other Party, regardless of which Party primarily drafted this Agreement.

14.8	If any provision of this Agreement is for any reason found to be invalid or unenforceable, such provision shall be interpreted to fulfill its intended purpose to the maximum extent permitted by applicable law and all other provisions of this Agreement nevertheless will remain enforceable.

14.9

In the event that Licensee (or its Affiliate) brings an action, or participates as an adverse party in any action, before any court, agency or tribunal seeking to invalidate or otherwise challenge the enforceability of or Board’s ownership of any patent included in the Licensed Patents, then MD Anderson may immediately terminate this Agreement upon written notice to Licensee and with no opportunity for Licensee to cure. Any dispute regarding the validity, enforceability or ownership of any patent included in the Licensed Patents shall be litigated in the courts located in Houston, Texas, and Licensee agrees not to challenge personal jurisdiction in that forum. To the extent that Licensee unsuccessfully challenges, or participates as an adverse party in an action that unsuccessfully challenges, the validity or enforceability of any patent included in the Licensed Patents, Licensee agrees to reimburse MD Anderson and Board for all costs and fees (including attorney’s fees) paid by MD Anderson and Board in defending against such challenge. Licensee understands and agrees that, in the event Licensee successfully challenges the validity or enforceability of any patent included in the Licensed Patents, all payments or other consideration made or otherwise provided by Licensee to MD Anderson prior to a final, non-appealable adjudication of invalidity and/or unenforceability shall be non-refundable. The obligations of this Section shall survive the expiration or termination of this Agreement.

14.10

This Agreement may be executed in one (1) or more counterparts, by original, facsimile or PDF signature, each of which shall be deemed an original, but all of which together shall constitute one and the same instrument. Signatures to this Agreement transmitted by facsimile, by email in “portable document format” (“.pdf”), or by any other electronic means intended to preserve the original graphic and pictorial appearance of this Agreement shall have the same effect as physical delivery of the paper document bearing original signature. In the event signatures are exchanged by facsimile and/or in “.pdf” format, each Party shall thereafter promptly provide an original signature page to the other Party.

14.11

MD Anderson, as an agency of the State of Texas and a member institution of The University of Texas System, is subject to the constitution and laws of the State of Texas and, under the constitution and laws of the State of Texas, possesses certain rights and privileges, is subject to certain limitations and restrictions, and only has such authority as is granted under the constitution and laws of the State of Texas. Moreover, notwithstanding the generality or specificity of any provision of this Agreement, the provisions of this Agreement as they pertain to MD Anderson are enforceable only to the extent authorized by the constitution and laws of the State of Texas. No Party to this Agreement will be required to perform or commit any act or omission that would violate any applicable law, including the constitution and laws of the State of Texas. Nothing in this Agreement shall be deemed as a waiver by Board, System or MD Anderson of its sovereign immunity.

[Signatures Appear on Following Page]

IN WITNESS WHEREOF, the Parties hereto have caused their duly authorized representatives to execute this Agreement.

BOARD OF REGENTS OF THE
UNIVERSITY OF TEXAS System, on behalf of

THE UNIVERSITY OF TEXAS M. D. ANDERSON CANCER CENTER

By:		/s/ Ben Melson

Printed Name:		Ben Melson

Title:		SVP, CFO

Date:		April 24, 2020

Approved as to Content:

By:		/s/ Ferran Prat
		Ferran Prat, J.D., Ph.D.
		Senior Vice President
		Research Administration & Industry Relations
		M. D. Anderson Cancer Center

Understood:

By:		/s/ Jack A. Roth
		Jack A. Roth, M.D.
		Professor, Thoracic & Cardio Surgery-Rsch
		M. D. Anderson Cancer Center

GENPREX, INC.

By:		/s/ Rodney Varner

Printed Name:		Rodney Varner

Title:		Chairman, Chief Executive Officer

Date:		May 4, 2020

EXHIBIT I

[*]

ex_147950.htm

Exhibit 31.1

CERTIFICATION OF CHIEF EXECUTIVE OFFICER OF GENPREX, INC. PURSUANT TO

RULES 13a-14(a) AND 15d-14(a) UNDER THE SECURITIES EXCHANGE ACT OF 1934,

AS ADOPTED PURSUANT TO SECTION 302 OF THE SARBANES-OXLEY ACT OF 2002

I, J. Rodney Varner, certify that:

I have reviewed this quarterly report on Form 10-Q of Genprex, Inc., a Delaware corporation (the “registrant”);

Based on my knowledge, this report does not contain any untrue statement of a material fact or omit to state a material fact necessary to make the statements made, in light of the circumstances under which such statements were made, not misleading with respect to the period covered by this report;

Based on my knowledge, the financial statements, and other financial information included in this report, fairly present in all material respects the financial condition, results of operations and cash flows of the registrant as of, and for, the periods presented in this report;

The registrant's other certifying officer and I are responsible for establishing and maintaining disclosure controls and procedures (as defined in Exchange Act Rules 13a-15(e) and 15d-15(e)) and internal control over financial reporting (as defined in Exchange Act Rules 13a-15(f) and 15d-15(f)) for the registrant and have:

(a)

Designed such disclosure controls and procedures, or caused such disclosure controls and procedures to be designed under our supervision, to ensure that material information relating to the registrant, including its consolidated subsidiaries, is made known to us by others within those entities, particularly during the period in which this report is being prepared;

(b)

Designed such internal control over financial reporting, or caused such internal control over financial reporting to be designed under our supervision, to provide reasonable assurance regarding the reliability of financial reporting and the preparation of financial statements for external purposes in accordance with generally accepted accounting principles;

(c)

Evaluated the effectiveness of the registrant's disclosure controls and procedures and presented in this report our conclusions about the effectiveness of the disclosure controls and procedures, as of the end of the period covered by this report based on such evaluation; and

(d)

Disclosed in this report any change in the registrant's internal control over financial reporting that occurred during the registrant's most recent fiscal quarter (the registrant's fourth fiscal quarter in the case of an annual report) that has materially affected, or is reasonably likely to materially affect, the registrant's internal control over financial reporting; and

The registrant's other certifying officer and I have disclosed, based on our most recent evaluation of internal control over financial reporting, to the registrant's auditors and the audit committee of the registrant's board of directors (or persons performing the equivalent functions):

(a)

All significant deficiencies and material weaknesses in the design or operation of internal control over financial reporting which are reasonably likely to adversely affect the registrant's ability to record, process, summarize and report financial information; and

(b)

Any fraud, whether or not material, that involves management or other employees who have a significant role in the registrant's internal control over financial reporting.

Date: May 14, 2020




	By:	/s/ J. Rodney Varner
		J. Rodney Varner
		Chief Executive Officer
		(Principal Executive Officer)

ex_147951.htm

Exhibit 31.2

CERTIFICATION OF CHIEF FINANCIAL OFFICER OF GENPREX, INC. PURSUANT TO

RULES 13a-14(a) AND 15d-14(a) UNDER THE SECURITIES EXCHANGE ACT OF 1934,

AS ADOPTED PURSUANT TO SECTION 302 OF THE SARBANES-OXLEY ACT OF 2002

I, Ryan M. Confer, certify that:

I have reviewed this quarterly report on Form 10-Q of Genprex, Inc., a Delaware corporation (the “registrant”);

(a)

(b)

(c)

(d)

(a)

(b)

Any fraud, whether or not material, that involves management or other employees who have a significant role in the registrant's internal control over financial reporting.

Date: May 14, 2020

By:

/s/ Ryan M. Confer

Ryan M. Confer

Chief Financial Officer

(Principal Financial and Accounting Officer)

ex_147952.htm

Exhibit 32.1

CERTIFICATIONS OF CEO AND CFO PURSUANT TO 18 U.S.C. SECTION 1350,

AS ADOPTED PURSUANT TO

SECTION 906 OF THE SARBANES-OXLEY ACT OF 2002

In connection with the Quarterly Report on Form 10-Q of Genprex, Inc. (the “Company”) for the period ended March 31, 2020 as filed with the Securities and Exchange Commission on the date hereof (the “Report”), each of the undersigned, J. Rodney Varner, Chief Executive Officer of the Company, and Ryan M. Confer, Chief Financial Officer of the Company, hereby certifies, pursuant to 18 U.S.C. § 1350, as adopted pursuant to § 906 of the Sarbanes-Oxley Act of 2002, that to the best of his knowledge:

(1)

The Report fully complies with the requirements of section 13(a) or 15(d) of the Securities Exchange Act of 1934; and

(2)

The information contained in the Report fairly presents, in all material respects, the financial condition and results of operations of the Company.

Date: May 14, 2020

	By:	/s/ J. Rodney Varner
		J. Rodney Varner
		Chief Executive Officer
		(Principal Executive Officer)


	By:	/s/ Ryan M. Confer
		Ryan M. Confer
		Chief Financial Officer
		(Principal Financial and Accounting Officer)

This certification accompanies the Report, is not deemed filed with the Securities and Exchange Commission and is not to be incorporated by reference into any filing of the Company under the Securities Act of 1933, as amended, or the Securities Exchange Act of 1934, as amended (whether made before or after the date of the Report), irrespective of any general incorporation language contained in such filing.

Note 1 - Description of Business and Basis of Presentation	3 Months Ended
	Mar. 31, 2020
Notes to Financial Statements
Organization, Consolidation and Presentation of Financial Statements Disclosure [Text Block]	Note 1 - Description of Business and Basis of Presentation Genprex, Inc. ("we" or "the Company") is a clinical stage gene therapy company developing potentially life-changing treatments for cancer and diabetes. Our cancer therapies are based upon our novel proprietary technology platform, including our lead drug candidate, Oncoprex™ immunogene therapy ("Oncoprex"), for non-small cell lung cancer ("NSCLC"). Oncoprex consists of a tumor suppressor gene inserted into a patient’s cells that has immunomodulatory effects and is thereby considered an “immunogene therapy”. The gene is one of a series of genes whose therapeutic use is covered by an exclusive worldwide license from The University of Texas MD Anderson Cancer Center ("MD Anderson"). We also are developing a pre-clinical gene therapy that is covered by an exclusive worldwide license from the University of Pittsburgh of the Commonwealth System of Higher Education that has the potential to cure type 1 and type 2 diabetes. This potential treatment works by transforming alpha cells in the pancreas into functional beta-like cells, which can produce insulin but are distinct enough from beta cells to evade the body’s immune system. Oncology Platform Technologies Our oncology platform technologies are designed to administer cancer fighting genes by encapsulating them into nanoscale hollow spheres called nanovesicles, which are then administered intravenously and taken up by tumor cells where they express proteins that are missing or found in low quantities. Oncoprex has a multimodal mechanism of action whereby it interrupts cell signaling pathways that cause replication and proliferation of cancer cells, re-establishes pathways for apoptosis, or programmed cell death, in cancer cells, and modulates the immune response against cancer cells. Oncoprex has also been shown to block mechanisms that create drug resistance. With Oncoprex, we are initially targeting NSCLC. According to the World Health Organization, in 2018 lung cancer was the leading cause of cancer deaths worldwide, causing more deaths than colorectal, breast, liver or stomach cancers. In 2018, there were more than 2 million new lung cancer cases and 1.7 million deaths from lung cancer worldwide. In the United States, according to the American Cancer Society, it is estimated that in 2020 there will be more than 228,000 new cases of lung cancer and more than 135,000 deaths from lung cancer. The American Society of Clinical Oncology reports that NSCLC represents 84 percent of all lung cancers and has a 24 percent five -year relative survival rate. However, according to the National Cancer Institute, 57 percent of lung cancer diagnoses are distant, or have metastasized, and the five -year relative survival rate for Stage IV (metastatic) NSCLC is approximately 5 percent. We believe that there is a significant unmet medical need for new treatments for NSCLC in the United States and globally, and we believe that Oncoprex may be suitable for a majority of NSCLC patients. In January 2020, we received a United States Food and Drug Administration ("FDA") Fast Track Designation for use of Oncoprex in combination with epidermal growth factor receptor ("EGFR") inhibitor osimertinib (AstraZeneca’s Tagrisso®) for the treatment of NSCLC patients with EFGR mutations whose tumors progressed after treatment with osimertinib alone. According to the FLAURA study sponsored by AstraZeneca, the median length of time that patients are treated with osimertinib before their tumors progress is approximately 18 months. Osimertinib is now considered a new standard of care for NSCLC patients with an EGFR mutation. Given this and receipt of FDA’s Fast Track Designation for use of Oncoprex combined with osimertinib in patients whose tumors progress on osimertinib, we are prioritizing this drug combination and patient population and plan to initiate a Phase I/II clinical trial of Oncoprex combined with osimertinib in late 2020 or early 2021. In 2019, preclinical data was presented by MD Anderson collaborators for the combination of TUSC2, the active agent in Oncoprex, with pembrolizumab (Merck’s Keytruda®), showing that TUSC2 combined with the checkpoint blockade mechanism of action of pembrolizumab was more effective than pembrolizumab alone in increasing the survival of mice with human immune cells (humanized mice) that had metastatic lung cancer. Also presented in 2019 by MD Anderson was pre-clinical data for the combination of TUSC2, pembrolizumab and chemotherapy for the treatment of some of the most resistant metastatic lung cancers. This study found that the addition of TUSC2, increases the effectiveness of pembrolizumab and chemotherapy, and thus, may improve on first -line standard of care for lung cancer. In early May 2020, we entered into a worldwide, exclusive license agreement with The Board of Regents of the University of Texas System on Behalf of the MD Anderson for the use of TUSC2 in combination with immunotherapies, including pembrolizumab. We believe that our platform technologies could allow delivery of a number of cancer fighting genes, alone or in combination with other cancer therapies, to combat multiple types of cancer. We believe that Oncoprex’s combination of pan-kinase inhibition, direct induction of apoptosis, anti-cancer immune modulation and complementary action with targeted drugs and immunotherapies is unique, and positions Oncoprex to provide treatment for patients with NSCLC and possibly other cancers, who are not benefitting from currently offered therapies. Diabetes Gene Therapy Diabetes is a chronic, metabolic disease characterized by elevated levels of blood glucose (or blood sugar), which leads over time to serious damage to the heart, blood vessels, eyes, kidneys and nerves. The most common is type 2 diabetes, usually in adults, which occurs when the body becomes resistant to insulin or does not make enough insulin. In the past three decades the prevalence of type 2 diabetes has risen dramatically. Type 1 diabetes, once known as juvenile diabetes or insulin-dependent diabetes, is a chronic condition in which the pancreas produces little or no insulin by itself. According to the International Diabetes Federation, in 2019 approximately 463 million people worldwide had diabetes and 4.2 million deaths were attributed to diabetes. Both the number of cases and the prevalence of diabetes have been steadily increasing over the past few decades. Our diabetes gene therapy was developed by lead researcher Dr. George Gittes, at the Rangos Research Center at UPMC Children’s Hospital of Pittsburgh. The therapy utilizes an infusion process in which an endoscope and an adeno-associated virus vector are used to deliver Pdx1 and MafA genes to the pancreas. The proteins these genes express have been shown to transform alpha cells in the pancreas into functional beta-like cells, which can produce insulin but are distinct enough from beta cells to evade the body’s immune system. The diabetes gene therapy has been tested in vivo in mice and nonhuman primates. In studies of diabetic mice, the gene therapy approach restored normal blood glucose levels for an extended period of time, typically around four months. According to Dr. Gittes, the duration of restored blood glucose levels in mice could translate to decades in humans. If successful, this gene therapy could eliminate the need for insulin replacement therapy for diabetic patients. Capital Requirements, Liquidity and Going Concern Considerations Our condensed financial statements are prepared using the generally accepted accounting principles (“GAAP”) applicable to a going concern, which contemplates the realization of assets and liquidation of liabilities in the normal course of business. However, as shown in the accompanying condensed financial statements, we have sustained substantial losses from operations since inception and have no current source of revenue. In addition, we have used, rather than provided, cash in our operations. We expect to continue to incur significant expenditures to further clinical trials for the commercial development of our product candidates. Management recognizes that we must obtain additional capital resources to successfully commercialize our product candidates. To date, we have received funding in the form of equity and debt, and we plan to seek additional funding in the future. However, no assurances can be given that we will be successful in raising additional capital. If we are not able to timely and successfully raise additional capital, the timing of our clinical trials, financial condition and results of operations will continue to be materially and adversely affected. These condensed financial statements do not include any adjustments relating to the recoverability and classification of recorded asset amounts and classification of liabilities.

Condensed Balance Sheets (Current Period Unaudited) (Parentheticals) - $ / shares	Mar. 31, 2020	Dec. 31, 2019
Preferred stock, par value (in dollars per share)	$ 0.001	$ 0.001
Preferred stock, shares authorized (in shares)		10,000,000
Preferred stock, shares issued (in shares)		0
Preferred stock, shares outstanding (in shares)	0	0
Common stock, par value (in dollars per share)	$ 0.001	$ 0.001
Common stock, shares authorized (in shares)	200,000,000	200,000,000
Common stock, shares issued (in shares)	32,849,841	19,263,841
Common stock, shares outstanding (in shares)	32,849,841	19,263,841

Note 4 - Investment Unit	3 Months Ended
Note 4 - Investment Unit	Mar. 31, 2020
Notes to Financial Statements
Investment Unit [Text Block]	Note 4 - Investment Unit The TETF was created as an incentive for economic development to the Texas economy by providing financial support that leverages private investment for the creation of high-quality technology jobs in Texas. The award received required us to comply with certain performance conditions to ensure the monies the Company received were used for development activities in the state of Texas, and that we maintained our corporate nexus in Texas. Further, in connection with the award, the Company issued the Investment Unit to the TETF. On September 25, 2017 and again on August 16, 2019, the Company entered into termination agreements with the Texas Treasury Safekeeping Trust Company, the entity managing and controlling TETF interests, that terminated Article II and the all remaining Articles of the Investment Unit, respectively, so that the entirety of the Investment Unit was effectively terminated. As further described below, the Investment Unit consisted of a Note and a Warrant. Promissory Note The Note was an obligation to repay the $4.5 million principal amount, with interest accrued at 8% per annum, but only if an event of default occurred prior to August 13, 2020. If no event of default occurred prior to August 13, 2020, the Note and all related interest would be cancelled. Consistent with the stated objectives of the TETF, an event of default that would trigger the repayment obligation under the Note was a failure to maintain our principal place of business or our principal executive offices headquartered in the State of Texas (referred to as the “Residency Requirement”) until August 13, 2020. Warrant The Warrant was an obligation to issue (a Right to Purchase by the TETF) shares of the same class of stock to be issued in a “First Qualifying Financing Transaction,” at 80% of the per share transaction value (effectively a 20% discount). Alternatively, the TETF could exercise its right to purchase at any time prior to the occurrence of a First Qualifying Financial Transaction for $0.001 per share. The Warrant included a provision that required changes in the strike price, driven by the pricing of the “First Qualifying Financing Transaction.” As a result, the Warrant embedded in the Investment Unit was accounted for as a derivative financial instrument and classified outside of equity under ASC 815 - 40 - 15, as the settlement adjustment from the future transaction did not permit for the strike price to be considered fixed. On March 12, 2014, the TETF exercised its Warrant for $0.001 per share, and we issued to the TETF an aggregate of 184,797 shares of our Series B preferred stock. These shares were subsequently forward-split and converted into an aggregate of 1,235,219 shares of our common stock in connection with our IPO. Accounting for the Investment Unit We accounted for the Investment Unit as a hybrid financial instrument under Financial Accounting Standards Boards Statement 155, and measured the Investment Unit at the amount of proceeds received from the TETF award. The First Qualifying Financial Transaction occurred during December 2013, resulting in an adjustment to the fair value of the Investment Unit in the amount of approximately $2.5 million. The TETF exercised the Warrant for $0.001 per share. We received notice of purchase from the TETF during March 2014, and issued 184,797 shares of Series B preferred stock, which has since been converted to 1,235,219 shares of our common stock upon completion of our IPO. Upon exercise by the TETF of the Warrant, the remaining component within the Investment Unit was the Note. The Investment Unit was valued at zero, because our obligation to repay the Note arose from an event of default (a failure to maintain the Texas Residency Requirement), which was an event which rested entirely within our control.

Note 8 - Significant Events	3 Months Ended
Note 8 - Significant Events	Mar. 31, 2020
Notes to Financial Statements
Effect of Covid 19 Pandemic [Text Block]	Note 8 - Significant Events In March 2020, the outbreak of COVID- 19 caused by a novel strain of the coronavirus was recognized as a pandemic by the World Health Organization. The pandemic has become increasingly widespread in the United States, including markets in which the Company operates or may operate in the future. The COVID- 19 pandemic has had a notable impact on general economic conditions, including, but not limited to, the temporary closures of many businesses, “shelter in place” orders and other governmental regulations, reduced consumer spending due to both job losses and other effects attributable to the COVID- 19, in addition to many other unknowns. The Company has not experienced any material impact on financial results or operations during the three -month period ended March 31, 2020 as a result of the COVID- 19 pandemic. The extent to which the COVID- 19 pandemic could impact the Company's operations or financial results is uncertain. The Company continues to monitor the impact of the COVID- 19 pandemic closely.

Note 2 - Summary of Significant Accounting Policies (Details Textual)		1 Months Ended	3 Months Ended		12 Months Ended
	Apr. 03, 2018 $ / shares shares	Dec. 31, 2013 USD ($)	Mar. 31, 2020 USD ($) $ / shares shares	Mar. 31, 2019 USD ($)	Dec. 31, 2019 USD ($) $ / shares shares	Dec. 31, 2011 USD ($)	Dec. 31, 2010 USD ($)	Mar. 31, 2018 $ / shares shares
Stockholders' Equity Note, Stock Split, Conversion Ratio	6.6841954
Capital Stock, Shares Authorized (in shares) \| shares								210,000,000
Common Stock, Shares Authorized (in shares) \| shares	200,000,000		200,000,000		200,000,000			200,000,000
Common Stock, Par or Stated Value Per Share (in dollars per share) \| $ / shares	$ 0.001		$ 0.001		$ 0.001			$ 0.001
Preferred Stock, Shares Authorized (in shares) \| shares	10,000,000				10,000,000			10,000,000
Preferred Stock, Par or Stated Value Per Share (in dollars per share) \| $ / shares			$ 0.001		$ 0.001			$ 0.001
Cash Equivalents, at Carrying Value, Total			$ 0		$ 0
Cash, Uninsured Amount			22,829,591		1,761,278
Research and Development Assets, Current			882,637		801,780
State of Texas Emerging Technology Fund Award Amount							$ 4,500,000
Proceeds from State of Texas Emerging Technology Fund Award						$ 2,250,000	2,250,000
Revenues, Total
Fair Value Adjustment of Warrants		$ 2,500,000			0
Impairment of Long-Lived Assets Held-for-use			$ 0		$ 0
Grant [Member] \| U.S. Treasury Department [Member]
Revenues, Total							$ 244,500
Minimum [Member]
Property, Plant and Equipment, Useful Life (Year)			3 years
Maximum [Member]
Property, Plant and Equipment, Useful Life (Year)			5 years

Note 5 - Equity - Assumptions (Details)	3 Months Ended
Note 5 - Equity - Assumptions (Details)	Mar. 31, 2020
Expected term: (Year)	10 years
Dividend yield:	0.00%
Minimum [Member]
Risk-free rate:	0.21%
Volatility:	75.98%
Maximum [Member]
Risk-free rate:	2.63%
Volatility:	79.89%

Note 9 - Subsequent Events (Details Textual)				3 Months Ended	12 Months Ended
Note 9 - Subsequent Events (Details Textual)	Apr. 27, 2020 USD ($) shares	Apr. 24, 2020 $ / shares shares	Apr. 01, 2020 shares	Mar. 31, 2020 $ / shares shares	Dec. 31, 2019 $ / shares shares	May 04, 2020
Stock Issued During Period, Shares, Issued for Services (in shares)				5,000	506,707
Share-based Compensation Arrangement by Share-based Payment Award, Options, Grants in Period, Gross (in shares)				1,165,325	1,744,300
Class of Warrant or Right, Issued During Period, Exercise Price (in dollars per share) \| $ / shares					$ 0.46
Subsequent Event [Member]
Stock Issued During Period, Shares, Issued for Services (in shares)			5,000
Subsequent Event [Member] \| License Agreement [Member] \| MD Anderson [Member]
Number of Allowed Patents						16
Subsequent Event [Member] \| Dr. Julian Pham [Member]
Months of Pay Eligible to be Received (Month)	150 days
Base Salary \| $	$ 375,000
Aggregate Amount of Base Salary Eligible to be Received \| $	$ 156,250
Months of Insurance Coverage Eligible for Reimbursement (Month)	150 days
Share-based Compensation Arrangement by Share-based Payment Award, Options, Exercisable, Number (in shares)	410,117
Subsequent Event [Member] \| Warrants Issued for Services [Member]
Class of Warrant or Right, Number of Securities Called by Each Warrant or Right (in shares)		500,000
Class of Warrant or Right, Issued During Period, Exercise Price (in dollars per share) \| $ / shares		$ 2.27
Subsequent Event [Member] \| New Employee [member]
Share-based Compensation Arrangement by Share-based Payment Award, Options, Grants in Period, Gross (in shares)		50,000

Note 5 - Equity - Stock Option Activity (Details) - $ / shares	3 Months Ended	12 Months Ended
	Mar. 31, 2020	Dec. 31, 2019
Outstanding, number of shares (in shares)	5,982,923	4,535,681
Outstanding, weighted average exercise price (in dollars per share)	$ 2.66	$ 3.31
Options granted, number of shares (in shares)	1,165,325	1,744,300
Options granted, weighted average exercise price (in dollars per share)	$ 2	$ 1.48
Options exercised, number of shares (in shares)
Options exercised, weighted average exercise price (in dollars per share)
Options expired, number of shares (in shares)		(297,058)
Options expired, weighted average exercise price (in dollars per share)
Outstanding, number of shares (in shares)	7,148,248	5,982,923
Outstanding, weighted average exercise price (in dollars per share)	$ 2.55	$ 2.66

Condensed Statements of Cash Flows (Unaudited) - USD ($)	3 Months Ended		12 Months Ended
	Mar. 31, 2020	Mar. 31, 2019	Dec. 31, 2019
Cash flows from operating activities:
Net loss	$ (5,566,220)	$ (2,158,846)
Adjustments to reconcile net loss to net cash used in operating activities:
Depreciation	5,353	2,931
Share based compensation	753,994	523,022
Changes in operating assets and liabilities:
Accounts receivable	655	9,297
Prepaid expenses and other	102,148	136,593
Deposits		1,950
Accounts payable and accrued expenses	202,134	(88,818)
Other current liabilities	(15,592)	(67,922)
Net cash used in operating activities	(4,517,528)	(1,641,793)
Cash flows from investing activities:
Additions to property and equipment	(11,412)	(4,111)
Additions to intellectual property	(44,744)	(9,220)
Additions to research and development supplies	(80,857)
Net cash used in investing activities	(137,013)	(13,331)
Cash flows from financing activities:
Proceeds from issuances of stock	25,731,640
Net cash provided by financing activities	25,731,640
Net increase (decrease) in cash	21,077,099	(1,655,124)
Cash, beginning of period	2,002,492	8,600,918	$ 8,600,918
Cash, end of period	23,079,591	6,945,794	$ 2,002,492
Supplemental Disclosure of Cash Flow Information
Cash paid for interest
Cash paid for taxes

Condensed Balance Sheets (Current Period Unaudited) - USD ($)	Mar. 31, 2020	Dec. 31, 2019
Common stock, par value (in dollars per share)	$ 0.001	$ 0.001
Current assets:
Cash	$ 23,079,591	$ 2,002,492
Accounts receivable		655
Prepaid expenses and other	69,568	171,716
Supplies	882,637	801,780
Total current assets	24,031,796	2,976,643
Property and equipment, net	50,713	44,654
Other assets:
Security deposits	21,732	21,732
Intellectual property, net	535,944	491,200
Total other assets	557,676	512,932
Total assets	24,640,185	3,534,229
Current liabilities:
Accounts payable and accrued expenses	638,392	436,258
Other current liabilities	58,834	74,426
Total current liabilities	697,226	510,684
Investment unit	0	0
Commitments and contingencies
Stockholders’ equity:
Preferred stock $0.001 par value: 10,000,000 shares authorized; no shares issued and outstanding
Common stock $0.001 par value: 200,000,000 shares authorized; 32,849,841 and 19,263,841 shares issued and outstanding, respectively	32,850	19,264
Additional paid-in capital	69,955,788	43,483,740
Accumulated deficit	(46,045,679)	(40,479,459)
Total stockholders’ equity	23,942,959	3,023,545
Total liabilities and stockholders’ equity	$ 24,640,185	$ 3,534,229

Note 4 - Investment Unit (Details Textual) - USD ($)			1 Months Ended	3 Months Ended	12 Months Ended
Note 4 - Investment Unit (Details Textual) - USD ($)	Apr. 03, 2018	Mar. 12, 2014	Dec. 31, 2013	Mar. 31, 2018	Dec. 31, 2019	Mar. 31, 2020	Dec. 31, 2018
Class of Warrant or Right, Exercise Price of Warrants or Rights (in dollars per share)					$ 1.45	$ 1.45	$ 2.36
Fair Value Adjustment of Warrants			$ 2,500,000		$ 0
Conversion of Preferred Stock to Common Stock [Member]
Conversion of Stock, Shares Issued (in shares)	1,235,219			9,324,177
Series B Preferred Stock [Member]
Stock Issued During Period, Shares, New Issues (in shares)		184,797
Warrant Issued to TETF [Member]
Class of Warrant or Right, Purchase Percentage						80.00%
Warrant Discount Rate						20.00%
Class of Warrant or Right, Exercise Price of Warrants or Rights (in dollars per share)		$ 0.001				$ 0.001
Promissory Note [Member]
Contingent Debt						$ 4,500,000
Contingent Debt, Interest Rate						8.00%

Note 5 - Equity

3 Months Ended

Mar. 31, 2020

Notes to Financial Statements

Stockholders' Equity Note Disclosure [Text Block]

Note

- Equity

Registered Direct Offerings

November 22, 2019,

the Company completed a registered direct offering (“RDO”), whereby the Company sold to investors an aggregate of

3,167,986

shares of the Company’s common stock at

$0.40

per share and warrants to purchase up to

3,167,986

shares of the Company’s common stock at an exercise price of

$0.46

per share. The warrants are

first

exercisable on

May 22, 2020.

The Company received net proceeds of approximately

$1,093,000

after commissions and expenses. Additionally, the placement agent has been issued warrants to purchase common stock equal to

of the aggregate number of shares of common stock issued and issuable pursuant to the RDO (including shares underlying any warrants), or

443,518

shares of common stock at an exercise price of

125%

of the RDO price per share, or

$0.50

per share.

In connection with the closing of the Company’s RDO, the Company further adjusted the warrants to purchase up to

2,283,740

shares of the Company's common stock, that had been issued as part of the

May 9, 2018

private placement and adjusted in

August 2018

to (i) reduce the exercise price for each share from

$4.25

per share to

$0.46

per share, (ii) extended the date upon which such warrants could be initially exercised to

May

22,

2020,

and (iii) extended the termination date of the warrants by

six

months and

one

day.

January 21, 2020,

the Company completed a registered direct offering, in which the Company sold to an accredited investor

961,000

shares of the Company’s common stock at

$0.24

per share. The Company received net proceeds of approximately

$200,000

after commissions and expenses.

January 23, 2020,

the Company completed a registered direct offering, in which the Company sold to investors an aggregate of

7,620,000

shares of the Company’s common stock at

$1.05

per share. The Company received net proceeds of approximately

$7.2

million after commissions and expenses.

February 19, 2020,

the Company amended its Registration Statement on Form S-

to increase the maximum offering size by approximately

$3,000,000.

February 21, 2020,

the Company completed a registered direct offering under the amended S-

Registration Statement, in which the Company sold to investors an aggregate of

5,000,000

shares of the Company’s common stock at

$3.50

per share. The Company received net proceeds of approximately

$16

million after commissions and expenses.

Stock Issuances

During the

three

months ended

March 31, 2020

, we issued (i)

13,581,000

shares of common stock in the Company's registered direct offerings for cash of

$25,731,640,

and (ii)

5,000

shares of common stock for service provided to us, valued at

$1,550.

During the year ended

December 31, 2019

, we issued (i)

3,167,986

shares of common stock from the Company’s RDO for cash of

$1,267,194,

(ii)

506,707

shares of common stock for service provided to us, valued at

$469,588,

and (iii) we issued

350,000

shares of common stock held in abeyance for an investor in the

May 2018

private placement.

Preferred Stock

In connection with the Company’s IPO, all preferred stock included in Series A through Series G preferred stock, totaling

1,394,953

shares at

March 31, 2018

were converted to an aggregate of

9,324,177

shares of the Company's common stock in association with the forward-split (See Note

- Capital Stock). Upon the completion of the IPO, the Company became authorized to issue

10,000,000

shares of preferred stock at a par value of

$0.001

per share,

none

of which are outstanding at

March 31, 2020

Common Stock

Upon the completion of the IPO, all of the Company’s non-voting common stock automatically converted into voting common stock on a

one

-to-

one

basis. Immediately following the completion of the IPO, the Company became authorized to issue

200,000,000

shares of common stock at a par value of

$0.001

per share, all of which is voting common stock. There are

32,849,841

shares of common stock outstanding at

March 31, 2020

Common Stock Purchase Warrants

Common stock purchase warrant activity for the period and year ended

March 31, 2020

and

December 31, 2019

, respectively, are as follows:

	Number of		Weighted Avg.
	Warrants		Exercise Price
Outstanding at January 1, 2019		3,864,552	$	2.36
Issued		3,611,504		0.46
Cancelled or expired		—		—
Exercised		—		—
Outstanding at December 31, 2019		7,476,056	$	1.45
Issued		—		—
Cancelled or expired		—		—
Exercised		—		—
Outstanding at March 31, 2020		7,476,056	$	1.45

The Company did

not

issue warrants in the

three

-month period ended

March 31, 2020

In the year ended

December 31, 2019

, we (i) issued warrants to purchase

3,167,986

shares of our common stock at an exercise price of

$0.46

per share to the investors in the Company’s RDO, (ii) issued warrants to purchase

443,518

shares of our common stock at an exercise price of

$0.50

per share to the placement agent in the RDO, and (iii) reduced the purchase price of the warrants, issued to investors in the

May 2018

private placement, to purchase

2,283,740

shares of the Company’s common stock from

$4.25

per share to

$0.46

per share.

January 29, 2018,

the Company entered into an agreement with FundAthena, Inc. whereby the Company agreed to grant warrants to purchase

6,000

shares of our common stock at an exercise price of

$5.00

per share in consideration of services valued at

$30,000

provided to the Company. At

March 31, 2020

, the Company has

not

issued these warrants.

2018

Equity Incentive Plan

The Company’s board of directors and stockholders have approved and adopted the Company’s

2018

Equity Incentive Plan (

“2018

Plan”), which became effective on the completion of the IPO on

April 3, 2018.

The

2018

Plan provides for the grant of incentive stock options (“ISOs”), nonstatutory stock options, stock appreciation rights, restricted stock awards, restricted stock unit awards, performance-based stock awards, other forms of equity compensation and performance cash awards. ISOs

may

be granted only to employees. All other awards

may

be granted to employees, including officers, and to the Company’s non-employee directors and consultants, and affiliates.

A total of

4,160,000

shares of common stock are available under the

2018

Plan, which includes

554,963

shares of common stock reserved for issuance under our

2009

Equity Incentive Plan that were added to the

2018

Plan.

further grants will be made under the

2009

Plan and any shares subject to outstanding stock options under the

2009

Plan that would otherwise be returned to the

2009

Plan will instead be added to the shares initially reserved under the

2018

Plan.

In addition, the number of shares of common stock reserved for issuance under the

2018

Plan will automatically increase on

January 1

of each year, beginning on

January 1, 2020

of the total number of shares of the Company’s common stock outstanding on

December 31

of the preceding calendar year, or a lesser number of shares determined by the administrator of the

2018

Plan. On

January 1, 2019

and

2020,

the number of shares of common stock reserved for issuance under the

2018

Plan was increased by an aggregate of

761,957

and

963,192

shares, respectively.

2018

Employee Stock Purchase Plan

The Company’s board of directors and stockholders have approved and adopted the Company’s

2018

Employee Stock Purchase Plan (“ESPP”), which became effective on the completion of the IPO on

April 3, 2019.

The ESPP authorizes the issuance of

208,500

shares of the Company’s common stock pursuant to purchase rights granted to our eligible employees. The number of shares of common stock reserved for issuance will automatically increase on

January 1

of each calendar year, from

January 1, 2020

by the lesser of

of the total number of shares of our common stock outstanding on

December 31

of the preceding calendar year or a number determined by the administrator of the ESPP. The administrator of the ESPP, which is our Board of Directors, determined

not

to increase the number of shares reserved for issuance under the ESPP on

January 1, 2020

Stock Options

As of

March 31, 2020

, the Company has outstanding stock options to purchase

7,148,248

shares of common stock that have been granted to various employees, vendors and independent contractors. These options can vest immediately or over periods ranging from

months, are exercisable for a period of up to

ten

years, and enable the holders to purchase shares of our common stock at exercise prices ranging from

$0.001

$9.80.

The per-share fair values of these options range from

$0.001

$7.93,

based on Black-Scholes-Merton pricing models with the following assumptions:

Expected term:		10 years
Risk-free rate:		0.21% – 2.63%
Volatility:		75.98% – 79.89%
Dividend yield:		0%

In the

three

-month period ending

March 31, 2020

, the Company granted stock options to employees and consultants to purchase an aggregate of

1,165,325

shares of the Company's common stock with exercise prices ranging from

$1.28

$2.67

per share.

In the year ending

December 31, 2019,

Company granted stock options to employees and consultants to purchase an aggregate of

1,744,300

shares of common stock with exercise prices ranging from

$0.30

$1.62

per share and cancelled options to purchase

297,058

shares of common stock due to the inactivity of service providers.

The weighted average remaining contractual term for the outstanding options at

March 31, 2020

and

December 31, 2019

7.64

and

7.45

years, respectively.

Stock option activity for the

three

months and year ended

March 31, 2020

and

December 31, 2019

, respectively, is as follows:

	Number of			Weighted Avg.
	Shares			Exercise Price
Outstanding at January 1, 2019		4,535,681		$	3.31
Options granted		1,744,300			1.48
Options exercised		—			—
Options expired		(297,058	)		—
Outstanding at December 31, 2019		5,982,923		$	2.66
Options granted		1,165,325			2.00
Options exercised		—			—
Options expired or cancelled		—			—
Outstanding at March 31, 2020		7,148,248		$	2.55

Share-Based Compensation

The Company’s total compensation cost related to non-vested time-based stock option awards granted to employees and board members and

not

yet recognized was approximately

$5.3

million for the quarter ended

March 31, 2020

. The Company expects to record this stock-based compensation expense over the next

three

years in the amount of

$5.2

million with respect to stock option awards using a graded vesting method and

$0.1

million with respect to stock option awards using a cliff vesting method. As of

March 31, 2020

, the weighted average term over which these expenses are expected to be recognized are

2.21

years and

0.25

years, for stock options granted using a graded vesting method and a cliff vesting method, respectively.

As of

March 31, 2020

, the Company’s total compensation cost related to non-vested performance-based stock option awards granted to an employee and

not

yet recognized was approximately

$1.3

million. The entirety of this award

may

be recognized and recorded, upon the achievement of certain milestones, within

1.1

years from

March 31, 2020

In the

three

months ended

March 31, 2020

, the Company's total share-based compensation was approximately

$0.75

million, all of which represents the vesting of options issued to service providers, employees, and board members.

Note 9 - Subsequent Events	3 Months Ended
Note 9 - Subsequent Events	Mar. 31, 2020
Notes to Financial Statements
Subsequent Events [Text Block]	Note 9 - Subsequent Events Lease Cancellation On April 1, 2020, the Company provided notice of cancellation of our lease in the Cambridge Innovation Center in Cambridge, Massachusetts, effective on April 30, 2020. Share Issuance On April 1, 2020, the Company issued 5,000 shares of stock to a service provider in consideration of services to be provided through June 30, 2020. Option Issuance On April 24, 2020, the Company granted stock options to a new employee to purchase 50,000 shares of common stock. Warrant Issuance On April 24, 2020, the Company issued a warrant to purchase 500,000 shares of common stock at an exercise price of $2.27 per share to a related party in conjunction with past and future services provided to the Company. Separation Agreement with President & CSO On April 27, 2020, Dr. Julien Pham resigned as the Company's President and Chief Scientific Officer. In connection with Dr. Pham’s resignation, the Company entered into a Separation Agreement with him pursuant to which Dr. Pham will continue to comply with certain restrictive covenants and obligations of confidentiality and in return will be entitled to receive (i) payment of five months of Dr. Pham’s base salary of $375,000, or an aggregate of $156,250, (ii) reimbursement for five months of insurance coverage under the Consolidated Omnibus Budget Reconciliation Act, if incurred, (iii) accelerated vesting of stock options with time-based vesting that would have vested had Dr. Pham remained employed with the Company, with the total number of shares for which such newly vested options are exercisable being 410,117. License Agreement On May 4, 2020, the Company entered into an exclusive worldwide license agreement with The Board of Regents of the University of Texas System on Behalf of the MD Anderson relating to a portfolio of 16 patent applications and related technology for the treatment of cancer using the Company’s lead drug candidate and immunotherapies.

Note 5 - Equity - Common Stock Purchase Warrant Activity (Details) - $ / shares	3 Months Ended	12 Months Ended
	Mar. 31, 2020	Dec. 31, 2019
Outstanding, number of warrants (in shares)	7,476,056	3,864,552
Outstanding, weighted average exercise price (in dollars per share)	$ 1.45	$ 2.36
Issued, number of warrants (in shares)	0	3,611,504
Issued, weighted average exercise price (in dollars per share)		$ 0.46
Cancelled or expired, number of warrants (in shares)
Cancelled or expired, weighted average exercise price (in dollars per share)
Exercised, number of warrants (in shares)
Exercised, weighted average exercise price (in dollars per share)
Outstanding, number of warrants (in shares)	7,476,056	7,476,056
Outstanding, weighted average exercise price (in dollars per share)	$ 1.45	$ 1.45

Note 7 - Commitments and Contingencies (Details Textual) - USD ($)		1 Months Ended	3 Months Ended					12 Months Ended
	Apr. 16, 2018	Jul. 31, 2018	Mar. 31, 2020	Mar. 31, 2019	Jun. 30, 2017	Mar. 31, 2017	Dec. 31, 2016	Dec. 31, 2018	Dec. 31, 2016	Dec. 31, 2009	Dec. 31, 2019	Feb. 28, 2019	Oct. 31, 2017
Operating Lease, Rent Expense Per Month	$ 2,050
Payments to Acquire Intangible Assets			$ 44,744	$ 9,220
National Institute of Health [Member]
Royalty on Sales, Percentage										1.00%
Royalty Term (Year)										21 years
Royalty Payment, Annual Minimum										$ 20,000
Other Commitment, Total							$ 191,393		$ 191,393		$ 280,000
Legal Fees							15,393
Accounts Payable, Other, Current							176,000		176,000
Accrued Royalties, Current							$ 140,000		140,000
Other Expenses, Total									$ 36,000
Extinguishment of Debt, Amount						$ 120,000
Accrued Patent Costs, Current						36,000
Payments for Royalties					$ 20,000	20,000
Payment for Contingent Consideration Liability, Operating Activities						240,000
Contingent Payments Annual Increase						20,000
Payments to Acquire Intangible Assets					$ 36,000
Finite-Lived Intangible Assets, Period Increase (Decrease), Total						$ (120,000)
Clinical Trial Agreement [Member] \| MD Anderson [Member]
Long Term Contract, Estimated Cost								$ 2,000,000
Research Agreement [Member] \| MD Anderson [Member]
Long Term Contract, Estimated Cost		$ 2,000,000
License Agreement [Member] \| University of Pittsburgh [Member]
Licensing Fee, Amount												$ 25,000
Annual Maintenance Fee, First Three Years, Amount												25,000
Annual Maintenance Fee, After Year Three, Amount												40,000
Annual Royalty Payment Per Year, Minimum												$ 250,000
Share of Non-Royalty Sublicense Income, Percent												20.00%
License Agreement [Member] \| University of Pittsburgh [Member] \| Dosing of First Human Patient in a Phase I Clinical Trial [Member]
Milestone Payment												$ 3,975,000
License Agreement [Member] \| University of Pittsburgh [Member] \| Minimum [Member]
Percentage of Outstanding Shares for Warrant to Purchase Shares of Common Stock													1.50%
License Agreement [Member] \| University of Pittsburgh [Member] \| Maximum [Member]
Royalty Percent, Licensed Technology Covered by Patent												3.00%

Note 7 - Commitments and Contingencies	3 Months Ended
Note 7 - Commitments and Contingencies	Mar. 31, 2020
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 in Cambridge, Massachusetts. 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 in Austin, Texas. The Company pays $2,050 per month to occupy this location and the lease is effective until April 30, 2020. The Company is currently negotiating an extension of the lease. Commitments MD Anderson Cancer Center We have entered into a clinical study agreement with MD Anderson in Houston, Texas, to administer a Phase I/II clinical trial, combining FUS1 -nanoparticles and Erlotinib in Stage IV lung cancer patients. FUS1 is sometimes referred to as TUSC2. 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. With osimertinib now considered a new standard of care in the U.S. for NSCLC with an EGFR mutation and our receipt of FDA Fast-Track Designation for use of Oncoprex combined with Osimertinib, we are prioritizing this program in lieu of the combination trial of Oncoprex and erlotinib. 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 TUSC2 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. 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 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. 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 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 which increases annually by $20,000 and is $280,000 as of December 31, 2019 will be recognized when we obtain regulatory approval (the event that triggers the payment obligation). University of Pittsburgh As part of our License Agreement with the University of Pittsburgh in February 2020, we agreed to (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 between 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) milestone payments of an aggregate of $3,975,000 . 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.

Note 5 - Equity (Tables)

3 Months Ended

Mar. 31, 2020

Notes Tables

Schedule of Stockholders' Equity Note, Warrants or Rights [Table Text Block]

	Number of		Weighted Avg.
	Warrants		Exercise Price
Outstanding at January 1, 2019		3,864,552	$	2.36
Issued		3,611,504		0.46
Cancelled or expired		—		—
Exercised		—		—
Outstanding at December 31, 2019		7,476,056	$	1.45
Issued		—		—
Cancelled or expired		—		—
Exercised		—		—
Outstanding at March 31, 2020		7,476,056	$	1.45

Schedule of Share-based Payment Award, Stock Options, Valuation Assumptions [Table Text Block]

Expected term:		10 years
Risk-free rate:		0.21% – 2.63%
Volatility:		75.98% – 79.89%
Dividend yield:		0%

Share-based Payment Arrangement, Option, Activity [Table Text Block]

	Number of			Weighted Avg.
	Shares			Exercise Price
Outstanding at January 1, 2019		4,535,681		$	3.31
Options granted		1,744,300			1.48
Options exercised		—			—
Options expired		(297,058	)		—
Outstanding at December 31, 2019		5,982,923		$	2.66
Options granted		1,165,325			2.00
Options exercised		—			—
Options expired or cancelled		—			—
Outstanding at March 31, 2020		7,148,248		$	2.55

Condensed Statements of Operations (Unaudited) - USD ($)	3 Months Ended
	Mar. 31, 2020	Mar. 31, 2019
Revenues
Cost and expenses:
Depreciation	5,353	2,931
Research and development	1,477,877	508,042
General and administrative	4,092,996	1,659,796
Total costs and expenses	5,576,226	2,170,769
Operating loss	(5,576,226)	(2,170,769)
Interest income	10,006	11,923
Net loss	$ (5,566,220)	$ (2,158,846)
Net loss per share—basic and diluted (in dollars per share)	$ (0.20)	$ (0.14)
Weighted average number of common shares— basic and diluted (in shares)	27,952,742	15,335,772

Note 2 - Summary of Significant Accounting Policies	3 Months Ended
Note 2 - Summary of Significant Accounting Policies	Mar. 31, 2020
Notes to Financial Statements
Significant Accounting Policies [Text Block]	Note 2 - Summary of Significant Accounting Policies The Company’s condensed financial statements have been prepared in accordance with GAAP. However, they do not include all the information and footnotes required by GAAP for complete financial statements. In our opinion the unaudited condensed financial statements include all adjustments (consisting of normal recurring accruals) necessary to make the unaudited condensed financial statements not misleading. Operating results for the three months ended March 31, 2020 and 2019 are not necessarily indicative of the final results that may be expected for the year ending December 31, 2020 . For more complete financial information, these unaudited condensed financial statements should be read in conjunction with the Company's audited financial statements for the year ended December 31, 2019 filed with the Securities and Exchange Commission (“SEC”) on March 30, 2020. A summary of our significant accounting policies consistently applied in the preparation of the accompanying condensed financial statements follows. Capital Stock In connection with the Company’s initial public offering ("IPO") in April 2018, all of the Company’s preferred stock and non-voting common stock were converted into shares of the Company’s common stock. The Company’s common stock was then forward-split at a ratio of 6.6841954 -to- 1. Furthermore, prior to the closing of the IPO, the Company’s Certificate of Incorporation was amended and restated to provide the Company with the authority to issue up to 210,000,000 shares of stock consisting of 200,000,000 shares of common stock at a par value of $0.001 per share and 10,000,000 shares of preferred stock at a par value of $0.001 per share. Use of Estimates The preparation of our condensed financial statements in conformity with GAAP requires us to make estimates and assumptions that affect the reported amounts of assets and liabilities and disclosure of contingent assets and liabilities at the date of the condensed financial statements and the reported amounts of expenses during the reporting period. Actual results could differ from those estimates. Cash We consider all highly liquid short-term investments with an initial maturity of three months or less to be cash equivalents. Any amounts of cash in financial institutions which exceed FDIC insured limits expose us to cash concentration risk. We have no cash equivalents, and had $22,829,591 and $1,761,278 in excess of FDIC insured limits of $250,000 at March 31, 2020 and December 31, 2019 , respectively. Fair Value of Financial Instruments The carrying amounts reported in the balance sheet for cash, accounts receivable, accounts payable and accrued expenses approximate fair value because of the immediate or short-term maturity of these financial instruments. Accounting Standard Codification ("ASC") 820, Fair Value Measurements and Disclosures, defines fair value, provides a consistent framework for measuring fair value under GAAP and expands fair value financial statement disclosure requirements. ASC 820’s valuation techniques are based on observable and unobservable inputs. Observable inputs reflect readily obtainable data from independent sources, while unobservable inputs reflect our market assumptions. ASC 820 classifies these inputs into the following hierarchy: Level 1: Quoted prices for identical instruments in active markets Level 2: Quoted prices for similar instruments in active markets; quoted prices for identical or similar instruments in markets that are not active; and model-derived valuations whose inputs are observable or whose significant value drivers are observable Level 3: Instruments with primarily unobservable value drivers. Property and Equipment Furniture and equipment are stated at cost. Depreciation is calculated using the straight line method over the estimated useful lives of the assets, which range from three to five years. Routine maintenance and repairs are charged to expense as incurred and major renovations or improvements are capitalized. Research and Development Costs Research and development expenditures are comprised of costs incurred to conduct research and development activities. These include payments to collaborative research partners, manufacturing, and clinical strategy partners, wages and associated employee benefits, facilities and overhead costs. These expenditures relate to our preclinical, Phase I, and Phase II clinical trials and are expensed as incurred. Purchased materials to be used in future research are capitalized and included in research and development supplies. Supplies purchased and capitalized for future use was $882,637 and $801,780 at March 31, 2020 and December 31, 2019 , respectively. Awards In 2010, we were awarded $4.5 million from the State of Texas Emerging Technology Fund (“TETF”). The award was received in two tranches of $2.25 million during 2010 and 2011. The award proceeds were used for the development and future commercialization of our nanomolecular therapy product for the treatment of cancer. In consideration for the award, we provided the TETF with an “Investment Unit,” consisting of (i) a Promissory Note (“Note”) and (ii) a right to purchase our equity shares (“Warrant”). The funds received for this award were assigned to the Investment Unit, and classified separately from equity as “mezzanine” in the balance sheet. In 2010, we also were awarded approximately $244,500 from the U.S. Treasury Department for our QTDP Program Nanoparticle Therapy for Lung Cancer. The award was received during 2011 for our historical activities, and required no prospective expenditures. We accounted for these funds received as revenue at that time. Intellectual Property Intellectual property consists of external legal and related costs associated with patents and other proprietary technology acquired, licensed by, or maintained by us that we believe contribute to a probable economic benefit toward such patents and activities. These legal costs incurred in connection with the patent applications and patent maintenance are capitalized. Intellectual property is stated at cost, to be amortized on a straight-line basis over the estimated useful lives of the assets. Accounting for Stock-Based Compensation We use the fair value-based method of accounting for stock-based compensation for options granted to employees, independent consultants and contractors. We measure options granted at fair value determined as of the grant date, and recognize the expense over the periods in which the related services are rendered based on the terms and conditions of the award. Generally, where the award only has a service condition, the requisite service period is the same as the vesting period. Financial Instruments We have elected the Fair Value Option to account for the Investment Unit at fair value as a combined hybrid financial instrument containing a Warrant and a Note (see Note 4 - Investment Unit). Prior to its exercise, the Warrant component was not classified within equity, as the exercise price of the Warrant was affected by the market price of our stock in a future qualifying financing transaction and was not considered to be indexed to our own stock. The Note is not classified within liabilities, as our management can determine the timing of the repayment obligation, if any. As a result, the Warrant and Note that comprised the Investment Unit were aggregated and classified within the mezzanine section of the balance sheet. Due to the contingent terms of the financial instruments, changes in the fair value of the Investment Unit were calculated and realized in earnings. In August 2019, the remaining articles of the Investment Unit were terminated. There were no changes in the fair value of the Investment Unit at March 31, 2020 . Long-Lived Assets We review long-lived assets and certain identifiable intangibles held and used for possible impairment whenever events or changes in circumstances indicate that the carrying amount of an asset may not be recoverable. In evaluating the fair value and future benefits of its intangible assets, management performs an analysis of the anticipated undiscounted future net cash flow of the individual assets over the remaining amortization period. We recognize an impairment loss if the carrying value of the asset exceeds the expected future cash flows. During the three months ended March 31, 2020 and the year ended December 31, 2019 , there were no deemed impairments of our long-lived assets. Recent Accounting Developments Accounting pronouncements issued but not effective until after March 31, 2020 are not expected to have a significant effect on our financial condition, results of operations, or cash flows.

Note 6 - Related Party Transactions	3 Months Ended
Note 6 - Related Party Transactions	Mar. 31, 2020
Notes to Financial Statements
Related Party Transactions Disclosure [Text Block]	Note 6 - Related Party Transactions Introgen Research Institute Introgen Research Institute (“IRI”) is a Texas-based technology company, currently affiliated with Rodney Varner, our Chief Executive Officer. In April 2009, prior to Mr. Varner becoming an officer and director of our Company in August 2012, we entered into an Assignment and Collaboration Agreement with IRI, providing us with the exclusive right to commercialize a portfolio of intellectual property. This agreement was amended in 2011 to include additional sublicensing of additional intellectual property made available to IRI from MD Anderson. Viet Ly The Company entered into a consulting agreement with Viet Ly on April 19, 2018. The Company agreed to pay Mr. Ly $175,000 initially, with compensation variable from time-to-time as determined by the Company, for strategic consulting services. The Company paid Mr. Ly $6,000 per month, or an aggregate of $18,000, during the period ended March 31, 2020 for strategic services.

Significant Accounting Policies (Policies)	3 Months Ended
Significant Accounting Policies (Policies)	Mar. 31, 2020
Accounting Policies [Abstract]
Stockholders' Equity, Policy [Policy Text Block]	Capital Stock In connection with the Company’s initial public offering ("IPO") in April 2018, all of the Company’s preferred stock and non-voting common stock were converted into shares of the Company’s common stock. The Company’s common stock was then forward-split at a ratio of 6.6841954 -to- 1. Furthermore, prior to the closing of the IPO, the Company’s Certificate of Incorporation was amended and restated to provide the Company with the authority to issue up to 210,000,000 shares of stock consisting of 200,000,000 shares of common stock at a par value of $0.001 per share and 10,000,000 shares of preferred stock at a par value of $0.001 per share.
Use of Estimates, Policy [Policy Text Block]	Use of Estimates The preparation of our condensed financial statements in conformity with GAAP requires us to make estimates and assumptions that affect the reported amounts of assets and liabilities and disclosure of contingent assets and liabilities at the date of the condensed financial statements and the reported amounts of expenses during the reporting period. Actual results could differ from those estimates.
Cash and Cash Equivalents, Policy [Policy Text Block]	Cash We consider all highly liquid short-term investments with an initial maturity of three months or less to be cash equivalents. Any amounts of cash in financial institutions which exceed FDIC insured limits expose us to cash concentration risk. We have no cash equivalents, and had $22,829,591 and $1,761,278 in excess of FDIC insured limits of $250,000 at March 31, 2020 and December 31, 2019 , respectively.
Fair Value of Financial Instruments, Policy [Policy Text Block]	Fair Value of Financial Instruments The carrying amounts reported in the balance sheet for cash, accounts receivable, accounts payable and accrued expenses approximate fair value because of the immediate or short-term maturity of these financial instruments. Accounting Standard Codification ("ASC") 820, Fair Value Measurements and Disclosures, defines fair value, provides a consistent framework for measuring fair value under GAAP and expands fair value financial statement disclosure requirements. ASC 820’s valuation techniques are based on observable and unobservable inputs. Observable inputs reflect readily obtainable data from independent sources, while unobservable inputs reflect our market assumptions. ASC 820 classifies these inputs into the following hierarchy: Level 1: Quoted prices for identical instruments in active markets Level 2: Quoted prices for similar instruments in active markets; quoted prices for identical or similar instruments in markets that are not active; and model-derived valuations whose inputs are observable or whose significant value drivers are observable Level 3: Instruments with primarily unobservable value drivers.
Property, Plant and Equipment, Policy [Policy Text Block]	Property and Equipment Furniture and equipment are stated at cost. Depreciation is calculated using the straight line method over the estimated useful lives of the assets, which range from three to five years. Routine maintenance and repairs are charged to expense as incurred and major renovations or improvements are capitalized.
Research and Development Expense, Policy [Policy Text Block]	Research and Development Costs Research and development expenditures are comprised of costs incurred to conduct research and development activities. These include payments to collaborative research partners, manufacturing, and clinical strategy partners, wages and associated employee benefits, facilities and overhead costs. These expenditures relate to our preclinical, Phase I, and Phase II clinical trials and are expensed as incurred. Purchased materials to be used in future research are capitalized and included in research and development supplies. Supplies purchased and capitalized for future use was $882,637 and $801,780 at March 31, 2020 and December 31, 2019 , respectively.
Awards [Policy Text Block]	Awards In 2010, we were awarded $4.5 million from the State of Texas Emerging Technology Fund (“TETF”). The award was received in two tranches of $2.25 million during 2010 and 2011. The award proceeds were used for the development and future commercialization of our nanomolecular therapy product for the treatment of cancer. In consideration for the award, we provided the TETF with an “Investment Unit,” consisting of (i) a Promissory Note (“Note”) and (ii) a right to purchase our equity shares (“Warrant”). The funds received for this award were assigned to the Investment Unit, and classified separately from equity as “mezzanine” in the balance sheet. In 2010, we also were awarded approximately $244,500 from the U.S. Treasury Department for our QTDP Program Nanoparticle Therapy for Lung Cancer. The award was received during 2011 for our historical activities, and required no prospective expenditures. We accounted for these funds received as revenue at that time.
Intangible Assets, Finite-Lived, Policy [Policy Text Block]	Intellectual Property Intellectual property consists of external legal and related costs associated with patents and other proprietary technology acquired, licensed by, or maintained by us that we believe contribute to a probable economic benefit toward such patents and activities. These legal costs incurred in connection with the patent applications and patent maintenance are capitalized. Intellectual property is stated at cost, to be amortized on a straight-line basis over the estimated useful lives of the assets.
Share-based Payment Arrangement [Policy Text Block]	Accounting for Stock-Based Compensation We use the fair value-based method of accounting for stock-based compensation for options granted to employees, independent consultants and contractors. We measure options granted at fair value determined as of the grant date, and recognize the expense over the periods in which the related services are rendered based on the terms and conditions of the award. Generally, where the award only has a service condition, the requisite service period is the same as the vesting period.
Financial Instruments Measurement [Policy Text Block]	Financial Instruments We have elected the Fair Value Option to account for the Investment Unit at fair value as a combined hybrid financial instrument containing a Warrant and a Note (see Note 4 - Investment Unit). Prior to its exercise, the Warrant component was not classified within equity, as the exercise price of the Warrant was affected by the market price of our stock in a future qualifying financing transaction and was not considered to be indexed to our own stock. The Note is not classified within liabilities, as our management can determine the timing of the repayment obligation, if any. As a result, the Warrant and Note that comprised the Investment Unit were aggregated and classified within the mezzanine section of the balance sheet. Due to the contingent terms of the financial instruments, changes in the fair value of the Investment Unit were calculated and realized in earnings. In August 2019, the remaining articles of the Investment Unit were terminated. There were no changes in the fair value of the Investment Unit at March 31, 2020 .
Impairment or Disposal of Long-Lived Assets, Policy [Policy Text Block]	Long-Lived Assets We review long-lived assets and certain identifiable intangibles held and used for possible impairment whenever events or changes in circumstances indicate that the carrying amount of an asset may not be recoverable. In evaluating the fair value and future benefits of its intangible assets, management performs an analysis of the anticipated undiscounted future net cash flow of the individual assets over the remaining amortization period. We recognize an impairment loss if the carrying value of the asset exceeds the expected future cash flows. During the three months ended March 31, 2020 and the year ended December 31, 2019 , there were no deemed impairments of our long-lived assets.
New Accounting Pronouncements, Policy [Policy Text Block]	Recent Accounting Developments Accounting pronouncements issued but not effective until after March 31, 2020 are not expected to have a significant effect on our financial condition, results of operations, or cash flows.

Note 3 - Intellectual Property	3 Months Ended
Note 3 - Intellectual Property	Mar. 31, 2020
Notes to Financial Statements
Intangible Assets Disclosure [Text Block]	Note 3 - Intellectual Property On February 11, 2020, the Company entered into an exclusive license agreement with the University of Pittsburgh for patented gene therapy technologies relating to the potential treatment of Type 1 and Type 2 diabetes. We have exclusive license agreements on 34 issued patents for technologies developed by researchers at the National Cancer Institute, MD Anderson, the University of Texas Southwestern Medical Center, and the University of Pittsburgh. These patents comprise various therapeutic, diagnostic, technical and processing claims. These license rights will be amortized on a straight-line basis over the estimated period of useful lives of the underlying patents or the license agreements.

Condensed Statements of Changes in Stockholders' Equity (Unaudited) - USD ($)	Common Stock [Member]	Additional Paid-in Capital [Member]	Retained Earnings [Member]	Total
Balance (in shares) at Dec. 31, 2018	15,239,148
Balance at Dec. 31, 2018	$ 15,240	$ 38,690,586	$ (29,824,691)	$ 8,881,135
Issuance of stock for cash (in shares)	200,000
Issuance of stock for cash	$ 200			200
Issuance of stock for services (in shares)	121,617
Issuance of stock for services	$ 122			122
Share based compensation		522,700		522,700
Net loss			(2,158,846)	(2,158,846)
Balance (in shares) at Mar. 31, 2019	15,560,765
Balance at Mar. 31, 2019	$ 15,562	39,213,286	(31,983,537)	7,245,311
Balance (in shares) at Dec. 31, 2018	15,239,148
Balance at Dec. 31, 2018	$ 15,240	38,690,586	(29,824,691)	$ 8,881,135
Issuance of stock for services (in shares)				506,707
Issuance of stock for services				$ 469,588
Balance (in shares) at Dec. 31, 2019	19,263,841
Balance at Dec. 31, 2019	$ 19,264	43,483,740	(40,479,459)	3,023,545
Issuance of stock for cash (in shares)	13,581,000
Issuance of stock for cash	$ 13,581	25,718,059		$ 25,731,640
Issuance of stock for services (in shares)	5,000			5,000
Issuance of stock for services	$ 5	1,545		$ 1,550
Share based compensation		752,444		752,444
Net loss			(5,566,220)	(5,566,220)
Balance (in shares) at Mar. 31, 2020	32,849,841
Balance at Mar. 31, 2020	$ 32,850	$ 69,955,788	$ (46,045,679)	$ 23,942,959

Document And Entity Information - shares	3 Months Ended
Document And Entity Information - shares	Mar. 31, 2020	May 11, 2020
Document Information [Line Items]
Entity Registrant Name	Genprex, Inc.
Entity Central Index Key	0001595248
Trading Symbol	gnpx
Current Fiscal Year End Date	--12-31
Entity Filer Category	Non-accelerated Filer
Entity Current Reporting Status	Yes
Entity Emerging Growth Company	true
Entity Ex Transition Period	true
Entity Small Business	true
Entity Interactive Data Current	Yes
Entity Common Stock, Shares Outstanding (in shares)		32,854,841
Entity Shell Company	false
Document Type	10-Q
Document Period End Date	Mar. 31, 2020
Document Fiscal Year Focus	2020
Document Fiscal Period Focus	Q1
Amendment Flag	false
Title of 12(b) Security	Common Stock, par value $0.001 per share

Note 5 - Equity (Details Textual)									3 Months Ended			12 Months Ended
Note 5 - Equity (Details Textual)	Feb. 21, 2020 USD ($) $ / shares shares	Feb. 19, 2020 USD ($)	Jan. 23, 2020 USD ($) $ / shares shares	Jan. 21, 2020 USD ($) $ / shares shares	Jan. 01, 2020 shares	Nov. 22, 2019 USD ($) $ / shares shares	Jan. 01, 2019 shares	Apr. 03, 2018 $ / shares shares	Mar. 31, 2020 USD ($) $ / shares shares	Mar. 31, 2019 USD ($)	Mar. 31, 2018 $ / shares shares	Dec. 31, 2019 USD ($) $ / shares shares	Dec. 31, 2018 $ / shares shares	Jan. 29, 2018 USD ($) $ / shares shares
Class of Warrant or Right, Exercise Price of Warrants or Rights (in dollars per share) \| $ / shares									$ 1.45			$ 1.45	$ 2.36
Proceeds from Issuance of Common Stock \| $									$ 25,731,640
Stock Issued During Period, Shares, Issued for Services (in shares)									5,000			506,707
Stock Issued During Period, Value, Issued for Services \| $									$ 1,550	$ 122		$ 469,588
Preferred Stock, Shares Authorized (in shares)								10,000,000			10,000,000	10,000,000
Preferred Stock, Par or Stated Value Per Share (in dollars per share) \| $ / shares									$ 0.001		$ 0.001	$ 0.001
Preferred Stock, Shares Outstanding, Ending Balance (in shares)									0			0
Non-voting To Voting Common Stock, Conversion Ratio								1
Common Stock, Shares Authorized (in shares)								200,000,000	200,000,000		200,000,000	200,000,000
Common Stock, Par or Stated Value Per Share (in dollars per share) \| $ / shares								$ 0.001	$ 0.001		$ 0.001	$ 0.001
Common Stock, Shares, Outstanding, Ending Balance (in shares)									32,849,841			19,263,841
Class of Warrant or Right, Issued in Period (in shares)									0			3,611,504
Share-based Compensation Arrangement by Share-based Payment Award, Options, Outstanding, Number, Ending Balance (in shares)									7,148,248			5,982,923	4,535,681
Share-based Compensation Arrangement by Share-based Payment Award, Expiration Period (Year)									10 years
Share-based Compensation Arrangement by Share-based Payment Award, Options, Outstanding, Weighted Average Exercise Price, Ending Balance (in dollars per share) \| $ / shares									$ 2.55			$ 2.66	$ 3.31
Share-based Compensation Arrangement by Share-based Payment Award, Options, Grants in Period, Gross (in shares)									1,165,325			1,744,300
Share-based Compensation Arrangements by Share-based Payment Award, Options, Grants in Period, Weighted Average Exercise Price (in dollars per share) \| $ / shares									$ 2			$ 1.48
Share-based Compensation Arrangement by Share-based Payment Award, Options, Forfeitures and Expirations in Period, Total (in shares)												297,058
Share-based Compensation Arrangement by Share-based Payment Award, Options, Outstanding, Weighted Average Remaining Contractual Term (Year)									7 years 233 days			7 years 164 days
Share-based Payment Arrangement, Nonvested Award, Option, Cost Not yet Recognized, Amount \| $												$ 5,300,000
Share-based Payment Arrangement, Expense \| $									$ 750,000
Graded Vesting Method [Member]
Share-based Payment Arrangement, Nonvested Award, Option, Cost Not yet Recognized, Amount \| $												5,200,000
Cliff Vesting Method [Member]
Share-based Payment Arrangement, Nonvested Award, Option, Cost Not yet Recognized, Amount \| $												$ 100,000
Share-based Payment Arrangement, Option [Member]
Share-based Payment Arrangement, Nonvested Award, Cost Not yet Recognized, Period for Recognition (Year)												3 years
Performance Shares [Member]
Share-based Payment Arrangement, Nonvested Award, Cost Not yet Recognized, Period for Recognition (Year)												1 year 36 days
Share-based Payment Arrangement, Nonvested Award, Cost Not yet Recognized, Amount, Total \| $												$ 1,300,000
The 2018 Equity Incentive Plan [Member]
Share-based Compensation Arrangement by Share-based Payment Award, Number of Shares Available for Grant (in shares)								4,160,000
Share Based Compensation Arrangement By Share Based Payment Award, Percentage Applied on Outstanding Shares of Common Stock For Automatically Increase on Each Year								5.00%
Share-based Compensation Arrangement by Share-based Payment Award, Number of Additional Shares Authorized (in shares)					963,192		761,957
The 2009 Plan [Member]
Common Stock, Capital Shares Reserved for Future Issuance (in shares)								554,963
The 2018 Employee Stock Purchase Plan [Member]
Share Based Compensation Arrangement By Share Based Payment Award, Percentage Applied on Outstanding Shares of Common Stock For Automatically Increase on Each Year								2.00%
Share-based Compensation Arrangement by Share-based Payment Award, Number of Shares Authorized (in shares)								208,500
Minimum [Member]
Share-based Compensation Arrangement by Share-based Payment Award, Options, Outstanding, Weighted Average Exercise Price, Ending Balance (in dollars per share) \| $ / shares									$ 0.001
Share-based Compensation Arrangement by Share-based Payment Award, Options, Vested, Weighted Average Grant Date Fair Value (in dollars per share) \| $ / shares									0.001
Share-based Compensation Arrangements by Share-based Payment Award, Options, Grants in Period, Weighted Average Exercise Price (in dollars per share) \| $ / shares									1.28			$ 0.30
Maximum [Member]
Share-based Compensation Arrangement by Share-based Payment Award, Options, Outstanding, Weighted Average Exercise Price, Ending Balance (in dollars per share) \| $ / shares									9.80
Share-based Compensation Arrangement by Share-based Payment Award, Options, Vested, Weighted Average Grant Date Fair Value (in dollars per share) \| $ / shares									7.93
Share-based Compensation Arrangements by Share-based Payment Award, Options, Grants in Period, Weighted Average Exercise Price (in dollars per share) \| $ / shares									$ 2.67			$ 1.62
Weighted Average [Member] \| Share-based Payment Arrangement, Option [Member] \| Graded Vesting Method [Member]
Share-based Payment Arrangement, Nonvested Award, Cost Not yet Recognized, Period for Recognition (Year)												2 years 76 days
Weighted Average [Member] \| Share-based Payment Arrangement, Option [Member] \| Cliff Vesting Method [Member]
Share-based Payment Arrangement, Nonvested Award, Cost Not yet Recognized, Period for Recognition (Year)												91 days
Conversion of Preferred Stock to Common Stock [Member]
Conversion of Stock, Shares Converted (in shares)											1,394,953
Conversion of Stock, Shares Issued (in shares)								1,235,219			9,324,177
Warrants Issued with Registered Direct Offering [Member]
Class of Warrant or Right, Number of Securities Called by Warrants or Rights (in shares)						3,167,986
Class of Warrant or Right, Exercise Price of Warrants or Rights (in dollars per share) \| $ / shares						$ 0.46
Warrants Issued to Underwriter [Member]
Class of Warrant or Right, Number of Securities Called by Warrants or Rights (in shares)						443,518						3,167,986
Class of Warrant or Right, Exercise Price of Warrants or Rights (in dollars per share) \| $ / shares						$ 0.50						$ 0.46
Warrants, Exercise Price, Percentage of RDO Price Per Share (in dollars per share) \| $ / shares						$ 125
Warrants Issued for Services [Member] \| FundAthena, Inc [Member]
Class of Warrant or Right, Number of Securities Called by Warrants or Rights (in shares)														6,000
Class of Warrant or Right, Exercise Price of Warrants or Rights (in dollars per share) \| $ / shares														$ 5
Class of Warrant or Right, Issued in Period (in shares)													0
Accounts Payable, Total \| $														$ 30,000
Registered Direct Offering [Member]
Stock Issued During Period, Shares, New Issues (in shares)						3,167,986			13,581,000			3,167,986
Shares Issued, Price Per Share (in dollars per share) \| $ / shares						$ 0.40
Proceeds from Issuance of Common Stock \| $						$ 1,093,000			$ 25,731,640			$ 1,267,194
Registered Direct Offerings, Maximum Offering Size, Increase \| $		$ 3,000,000
Registered Direct Offering [Member] \| Underwriter [Member]
Stock Issued During Period, Shares, New Issues (in shares)												443,518
Shares Issued, Price Per Share (in dollars per share) \| $ / shares												$ 0.50
Percentage of Common Stock Issuance of Warrant or Right Issued						7.00%
Registered Direct Offering [Member] \| Accredited Investor [Member]
Stock Issued During Period, Shares, New Issues (in shares)				961,000
Shares Issued, Price Per Share (in dollars per share) \| $ / shares				$ 0.24
Proceeds from Issuance of Common Stock \| $				$ 200,000
Registered Direct Offering [Member] \| Investors [Member]
Stock Issued During Period, Shares, New Issues (in shares)	5,000,000		7,620,000
Shares Issued, Price Per Share (in dollars per share) \| $ / shares	$ 3.50		$ 1.05
Proceeds from Issuance of Common Stock \| $	$ 16,000,000		$ 7,200,000
Private Placement [Member]
Stock Issued During Period, Shares, New Issues (in shares)												350,000
Private Placement [Member] \| Securities Purchase Agreement [Member]
Class of Warrant or Right, Number of Securities Called by Warrants or Rights (in shares)												2,283,740
Class of Warrant or Right, Exercise Price of Warrants or Rights (in dollars per share) \| $ / shares												$ 0.46
Private Placement [Member] \| Securities Purchase Agreement [Member] \| Minimum [Member]
Class of Warrant or Right, Exercise Price of Warrants or Rights (in dollars per share) \| $ / shares												4.25
Private Placement [Member] \| Securities Purchase Agreement [Member] \| Maximum [Member]
Class of Warrant or Right, Exercise Price of Warrants or Rights (in dollars per share) \| $ / shares												$ 0.46

Note 6 - Related Party Transactions (Details Textual) - Viet Ly [Member] - USD ($)	3 Months Ended
	Mar. 31, 2020	Apr. 19, 2018
Related Party, Initial Annual Consulting Compensation to be Paid		$ 175,000
Related Party, Consulting Compensation Monthly Payment		$ 6,000
Related Party, Consulting Compensation, Aggregate Amount	$ 18,000