gnpx20210930

gnpx20210930_10q.htm

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 September 30, 2021

☐	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.)

3300 Bee Cave Road, #650-227, Austin, TX	78746
(Address of principal executive offices)	(Zip Code)

(512) 537-7997

(Registrant’s telephone number, including area code)

Not applicable

(Former name, former address and former fiscal year, if changed since last report)

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 (§232.405 of this chapter) 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 November 8, 2021, the registrant had 47,808,570 shares of common stock, par value $0.001 per share, outstanding.

GENPREX, INC.

TABLE OF CONTENTS

			Page No.

PART I	FINANCIAL INFORMATION		5

ITEM 1.	FINANCIAL STATEMENTS		5
	Condensed Balance Sheets as of September 30, 2021 (unaudited) and December 31, 2020		5
	Condensed Statements of Operations for the Three and Nine Months Ended September 30, 2021 and 2020 (unaudited)		6
	Condensed Statements of Changes in Stockholders' Equity for the Three and Nine Months Ended September 30, 2021 and 2020 (unaudited)		7
	Condensed Statements of Cash Flows for the Nine Months Ended September 30, 2021 and 2020 (unaudited)		8
	Notes to Unaudited Condensed Financial Statements		9
ITEM 2.	MANAGEMENT’S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS OF OPERATIONS		21
ITEM 3.	QUANTITATIVE AND QUALITATIVE DISCLOSURES ABOUT MARKET RISK		26
ITEM 4.	CONTROLS AND PROCEDURES		26

PART II	OTHER INFORMATION		27

ITEM 1.	LEGAL PROCEEDINGS		27
ITEM 1A.	RISK FACTORS		27
ITEM 2.	UNREGISTERED SALES OF EQUITY SECURITIES AND USE OF PROCEEDS		27
ITEM 3.	DEFAULTS UPON SENIOR SECURITIES		27
ITEM 4.	MINE SAFETY DISCLOSURES		27
ITEM 5.	OTHER INFORMATION		27
ITEM 6.	EXHIBITS		27
SIGNATURES		29

CAUTIONARY NOTE REGARDING FORWARD-LOOKING STATEMENTS AND INDUSTRY DATA

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:

●

our business strategies;

●

the timing of regulatory submissions;

●

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;

●

the timing and costs of clinical trials and the timing and costs of other expenses;

●

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;

●

market acceptance of our products;

●

our intellectual property;

●

our reliance on third party organizations;

●

our competitive position;

●

our industry environment;

●

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

●

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

●

management’s expectations with respect to future acquisitions;

●

our goals, intentions, plans and expectations, including the introduction of new products and markets; and

●

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, 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.

References to Genprex

Throughout this Quarterly Report on Form 10-Q, the “Company,” “Genprex,” “we,” “us,” and “our” refers to Genprex, Inc. and “our board of directors” refers to the board of directors of Genprex, Inc.

PART I - FINANCIAL INFORMATION

Item 1. Financial Statements

Genprex, Inc.

Condensed Balance Sheets (unaudited)

	*September 30,*			*December 31,*
	*2021*			*2020*
Assets		(unaudited)
Current assets:
Cash and cash equivalents	$	42,020,527		$	27,319,685
Accounts receivable	$	127		$	127
Prepaid expenses and other	$	749,029		$	384,553
Supplies	$	2,875,046		$	3,011,042
Total current assets	$	45,644,729		$	30,715,407
Property and equipment, net	$	44,342		$	39,441
Other assets:
Security deposits	$	10,741		$	10,741
Intellectual property, net	$	627,360		$	601,625
Total other assets	$	638,101		$	612,366
Total assets	$	46,327,172		$	31,367,214
Liabilities and Stockholders’ Equity
Current liabilities:
Accounts payable	$	591,941		$	192,968
Other current liabilities	$	569,952		$	257,756
Total current liabilities	$	1,161,893		$	450,724
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; 47,803,570 and 43,117,681 shares issued and outstanding, respectively	$	47,803		$	43,118
Additional paid-in capital	$	117,453,401		$	89,295,600
Accumulated deficit	$	(72,335,925	)	$	(58,422,228	)
Total stockholders’ equity	$	45,165,279		$	30,916,490
Total liabilities and stockholders’ equity	$	46,327,172		$	31,367,214

See accompanying notes to the unaudited condensed financial statements.

Genprex, Inc.

Condensed Statements of Operations (unaudited)

	*Three Months Ended*						*Nine Months Ended*
	*September 30,*						*September 30,*
	*2021*			*2020*			*2021*			*2020*
Revenues	$	—		$	—		$	—		$	—
Cost and expenses:
Depreciation		6,489			5,714			15,579			16,843
Research and development		1,431,999			1,350,016			5,127,419			4,983,530
General and administrative		2,000,437			1,421,863			8,774,844			7,731,550
Total costs and expenses		3,438,925			2,777,593			13,917,842			12,731,923
Operating loss		(3,438,925	)		(2,777,593	)		(13,917,842	)		(12,731,923	)
Interest income		1,060			2,650			4,146			17,467
Net loss		(3,437,865	)		(2,774,943	)		(13,913,696	)		(12,714,456	)
Net loss per share—basic and diluted	$	(0.07	)	$	(0.07	)	$	(0.30	)	$	(0.37	)
Weighted average number of common shares— basic and diluted		47,612,419			39,055,159			46,851,241			34,139,991

See accompanying notes to the unaudited condensed financial statements.

Genprex, Inc.

Condensed Statements of Changes in Stockholders' Equity (unaudited)

	*Common Stock*				*Additional*		*Accumulated*
	*Shares*		*Amount*		*Paid-In Capital*		*Deficit*			*Total*
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
Issuance of stock for cash		5,658,836		5,659		2,563,567		—			2,569,226
Issuance of stock for services		120,552		121		10,879		—			11,000
Share based compensation		—		—		2,359,621		—			2,359,621
Net loss		—		—		—		(4,373,293	)		(4,373,293	)
Balance at June 30, 2020		38,629,229	$	38,630	$	74,889,855	$	(50,418,972	)	$	24,509,513
Issuance of stock for cash		829,493		829		792,702		—			793,531
Issuance of stock for services		5,000		5		15,345		—			15,350
Share based compensation		—		—		432,590		—			432,590
Net loss		—		—		—		(2,774,943	)		(2,774,943	)
Balance at September 30, 2020		39,463,722	$	39,464	$	76,130,492	$	(53,193,915	)	$	22,976,041

Balance at December 31, 2020		43,117,681	$	43,118	$	89,295,601	$	(58,422,229	)	$	30,916,490
Issuance of stock for cash		4,192,139		4,192		25,320,138		—			25,324,330
Issuance of stock for services		5,000		5		20,645		—			20,650
Share based compensation		—		—		651,088		—			651,088
Net loss		—		—		—		(6,489,714	)		(6,489,714	)
Balance at March 31, 2021		47,314,820	$	47,315	$	115,287,472	$	(64,911,943	)	$	50,422,845
Issuance of stock for cash		203,037		203		109,830		—			110,033
Issuance of stock for services		5,000		5		21,095		—			21,100
Share based compensation		—		—		1,116,359		—			1,116,359
Net loss		—		—		—		(3,986,118	)	$	(3,986,118	)
Balance at June 30, 2021		47,522,857	$	47,523	$	116,534,756		(68,898,060	)	$	47,684,219
Issuance of stock for cash		275,713		275		243,273		—		$	243,548
Issuance of stock for services		5,000		5		16,795		—		$	16,800
Share based compensation		—		—		658,577		—		$	658,577
Net loss		—		—		—		(3,437,865	)	$	(3,437,865	)
Balance at September 30, 2021		47,803,570	$	47,803	$	117,453,401	$	(72,335,925	)	$	45,165,279

See accompanying notes to the unaudited condensed financial statements.

Genprex, Inc.

Condensed Statements of Cash Flows (unaudited)

	*Nine Months Ended September 30,*
	*2021*			*2020*
Cash flows from operating activities:
Net loss	$	(13,913,696	)	$	(12,714,456	)
Adjustments to reconcile net loss to net cash used in operating activities:
Depreciation		15,579			16,843
Share based compensation		2,484,574			3,572,439
Changes in operating assets and liabilities:
Accounts receivable		—			570
Prepaid expenses and other		(364,476	)		(783,401	)
Accounts payable		398,973			(114,834	)
Other current liabilities		312,196			(20,195	)
Net cash used in operating activities		(11,066,850	)		(10,043,034	)
Cash flows from investing activities:
Additions to property and equipment		(20,480	)		(14,529	)
Additions to intellectual property		(25,735	)		(96,512	)
Reduction to research and development supplies		135,996			115,456
Net cash provided by investing activities		89,781			4,415
Cash flows from financing activities:
Proceeds from issuances of stock		25,677,911			29,094,513
Net cash provided by financing activities		25,677,911			29,094,513
Net increase in cash and cash equivalents		14,700,842			19,055,894
Cash and cash equivalents, beginning of period		27,319,685			2,002,492
Cash and cash equivalents, end of period	$	42,020,527		$	21,058,386

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

We are a clinical stage gene therapy company focused on developing life-changing treatments for cancer and diabetes. Our lead cancer drug candidate, REQORSA™ Immunogene therapy drug (sometimes referred to as GPX-001), is being developed initially to treat non-small cell lung cancer ("NSCLC"). The active agent in REQORSA is a TUSC2 gene expressing plasmid that is encapsulated in a DOTAP cholesterol lipid nanoparticle. TUSC2 is a tumor suppressor gene which has both tumor killing (via apoptosis) and immunomodulatory effects. We utilize our novel proprietary ONCOPREX® Nanoparticle Delivery System to deliver the TUSC2 gene expressing plasmid to cancer cells. The TUSC2 gene is one of a series of genes whose therapeutic use is covered by our exclusive worldwide licenses from The University of Texas MD Anderson Cancer Center ("MD Anderson").

Our Acclaim-1 clinical trial is a Phase 1/2 study using a combination of REQORSA with AstraZeneca PLC’s Tagrisso® in patients with late-stage NSCLC with activating epidermal growth factor receptor ("EGFR") mutations, whose disease progressed after treatment with Tagrisso. In January 2020, we received U.S. Food and Drug Administration ("FDA") Fast Track Designation for use of REQORSA in combination with Tagrisso in patients with stage III or IV NSCLC with EGFR mutations that progressed after treatment with Tagrisso. In June 2021, we announced that the FDA had reviewed and confirmed all comments have been addressed regarding our Acclaim-1 clinical trial protocol and that we had engaged our first clinical site for our Acclaim-1 trial. This clinical trial is open for enrollment of patients, but we have not yet enrolled our first patient. We believe that the first patient will be enrolled in the fourth quarter of 2021, or the first quarter of 2022. We also believe that the rate of patient enrollment may increase as a result of the addition of clinical trial sites and as COVID-19 related site delays improve.

Our Acclaim-2 clinical trial is designed as a Phase 1/2 study using a combination of REQORSA with Merck & Co.’s Keytruda® in late stage NSCLC patients. Our trial design is informed by input from global leaders in lung cancer treatment. On October 1, 2021 we filed the Acclaim-2 protocol with the FDA as an amendment to our IND. We recently received FDA comments on the protocol to which we are responding and plan to discuss the Agency’s comments on the Phase 2 portion of the protocol prior to Phase 2 initiation. We believe any revisions to the protocol as a result of this FDA interaction will result in an optimized development plan. We expect that we will initiate the Phase 1 portion of the Acclaim-2 clinical trial by the end of calendar year 2021 and we will finalize the Phase 2 portion of the trial shortly thereafter, and in any event, well before the expected commencement of the Phase 2 study.

In diabetes, we are developing a gene therapy that is exclusively licensed from the University of Pittsburgh of the Commonwealth System of Higher Education ("University of Pittsburgh") for the treatment of Type 1 and Type 2 diabetes. This potential treatment is designed to work 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. Our diabetes product candidate is currently being evaluated in preclinical studies at the University of Pittsburgh.

Oncology Platform

Utilizing our non-viral ONCOPREX Nanoparticle Delivery System, we are developing cancer treatments that are designed to administer cancer fighting genes. We encapsulate the gene-expressing plasmids using lipid nanoparticles, and administer them intravenously, where they are then taken up by tumor cells and express proteins that are missing or found in low quantities in the tumor cells. With our lead drug candidate, REQORSA, there is a multimodal mechanism of action whereby REQORSA 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. REQORSA has also been shown to block mechanisms that create drug resistance.

We believe that our delivery system could allow delivery of a number of cancer-fighting genes, alone or in combination with other cancer therapies, to combat multiple types of cancer and are in early stages of discovery programs to identify early-stage candidates. We believe that REQORSA’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 REQORSA to provide treatment for patients with NSCLC and possibly other cancers, who are not benefitting from current therapies.

Diabetes Gene Therapy

Our pre-clinical diabetes gene therapy, also referred to as GPX-002, was discovered by lead researcher Dr. George Gittes, at the Rangos Research Center at the University of Pittsburgh Medical Center Children’s Hospital. This potential treatment is designed to work 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. The therapy utilizes a procedure in which an adeno-associated virus vector delivers Pdx1 and MafA genes to the pancreas.

Capital Requirements, Liquidity and Going Concern Considerations

Our unaudited condensed financial statements are prepared in accordance with U.S. 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 unaudited 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 may 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 unaudited 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 and nine months ended September 30, 2021 are not necessarily indicative of the final results that may be expected for the year ending December 31, 2021. 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, 2020, included in the Company's Annual Report on Form 10-K filed with the U.S. Securities and Exchange Commission on March 26, 2021. A summary of our significant accounting policies consistently applied in the preparation of the accompanying unaudited 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 unaudited 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 unaudited condensed financial statements and the reported amounts of expenses during the reporting period. Actual results could differ from those estimates.

Cash and Cash Equivalents

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 cash equivalents in a money market account and had $41,770,489 and $27,091,596 in excess of FDIC insured limits of $250,000 at September 30, 2021 and December 31, 2020, 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 Standards 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 consist of costs incurred to conduct research, develop engineering materials for further study, and develop clinical strategy for future programs. These costs include payments to collaborative research partners, manufacturing partners and consultants, and clinical strategy partners, wages and associated employee benefits, facilities and overhead costs. These expenditures relate to our preclinical and Phase 1/2 clinical trials and are expensed as incurred. Materials produced to be used in clinical research are capitalized and included in research and development supplies and are expensed as they are used for testing, clinical activities, or have spoiled. Research and development supplies purchased and capitalized for future use were $2,875,046 and $3,011,042 at September 30, 2021 and December 31, 2020, 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 each during 2010 and 2011. The award proceeds were used to further the development and future commercialization of REQORSA, our lead product candidate for NSCLC. In consideration of the award, we provided the TETF with an investment unit that consisted of a promissory note ("Note") and a warrant to purchase equity ("Warrant"). The Warrant was exercised in March 2014 and TETF was issued 1,235,219 shares of our common stock. The investment unit, including the Note, was terminated on August 15, 2019.

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 legal and related costs associated with patents and other proprietary technology and rights developed, acquired, licensed by, or maintained by us that we believe contribute to a probable economic benefit toward such patents and activities. These costs incurred in connection with obtaining and maintaining intellectual property protection, such as 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.

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 nine months ended September 30, 2021, and the year ended December 31, 2020, there were no deemed impairments of our long-lived assets.

Recent Accounting Developments

Accounting pronouncements issued but not effective until after September 30, 2021, 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.

On May 4, 2020, we 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, REQORSA, and immunotherapies.

We have exclusive license agreements relating to 15 issued patents and 18 pending patent applications worldwide, two of which have been allowed, 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 - Equity

Registered Direct Offerings

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 pursuant to 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 $16.0 million after commissions and expenses.

On December 24, 2020, the Company completed a registered direct offering in which the Company sold to an accredited investor 3,116,884 shares of the Company’s common stock at $3.85 per share. The Company received net proceeds of approximately $11.2 million after commissions and expenses.

On February 10, 2021, the Company completed a registered direct offering in which the Company sold to investors an aggregate of 4,000,000 shares of the Company's common stock at $6.25 per share. The Company received net proceeds of approximately $23.2 million after commissions and expenses.

Stock Issuances

During the nine months ended September 30, 2021, we issued (i) 4,000,000 shares of common stock in a registered direct offering for gross proceeds of $25,000,000, (ii) 670,889 shares of common stock upon the exercise of options for cash proceeds of $677,912, and (iii) 15,000 shares of common stock for services provided to us valued at $58,550 to the Chairman of our Scientific Advisory Board.

During the year ended December 31, 2020, we issued (i) 16,697,884 shares of common stock from registered direct offerings for gross proceeds of $37,731,643, (ii) 1,277,743 shares of common stock upon the exercise of options for cash proceeds of $1,320,155, (iii) 5,511,599 shares of common stock upon the exercise of warrants for cash proceeds of $2,537,731, (iv) 199,630 shares of common stock upon the exercise of warrants on a cashless basis, and (v) 51,432 shares of common stock for service provided to us valued at $154,648.

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 were converted to an aggregate of 9,324,177 shares of the Company's common stock in connection 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 September 30, 2021.

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-for-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 were 47,803,570 shares of the Company's common stock outstanding at September 30, 2021.

Common Stock Purchase Warrants

Common stock purchase warrant activity for the period and year ended September 30, 2021, and December 31, 2020, respectively, is as follows:

	*Number of*			*Weighted Average*
	*Warrants*			*Exercise Price*
Outstanding at January 1, 2020		7,476,056		$	1.45
Issued		550,000			2.41
Cancelled or expired		(44,528	)		0.50
Exercised		(5,826,781	)		0.47
Outstanding at December 31, 2020		2,154,747		$	4.37
Issued		50,000			5.29
Cancelled or expired		—			—
Exercised		—			—
Outstanding at September 30, 2021		2,204,747		$	4.39
Vested or expected to vest at September 30, 2021		41,665			3.54
Exercisable at September 30, 2021		1,971,412		$	4.62

During the nine-month period ended September 30, 2021, the Company issued (i) a warrant to purchase up to 25,000 shares of common stock to a service provider at an exercise price of $7.22 per share, the fair market value of a share of common stock on the date of issuance and (ii) a warrant to purchase up to 25,000 shares of common stock to a service provider at an exercise price of $3.36 per share, the fair market value of a share of common stock on the date of issuance. During the nine-month period ended September 30, 2021, we recorded share-based compensation of $200,282 associated with the vesting of warrants.

During the year ended December 31, 2020, (i) investors and placement agents of the Company's May 2018 private placement and November 2019 registered direct offering exercised warrants to purchase 5,511,599 shares of common stock for cash proceeds of $2,537,731, (ii) the Company issued 315,182 shares of common stock to the placement agents of the November 2019 registered direct offering upon the exercise of warrants on a cashless basis, and (iii) the Company issued warrants to purchase up to 550,000 shares of common stock to service providers, including 500,000 shares of common stock to Cancer Revolution, LLC, an entity owned and managed by Viet Ly, an advisor to the Company, at an exercise price of $2.27 per share, the fair market value of a share of common stock on the date of issuance and 50,000 shares of common stock to Capital City Technical Consulting, Inc., a service provider, at an exercise price of $3.81 per share, the fair market value of a share of common stock on the date of issuance. A principal of Capital City Technical Consulting, Inc. also serves as our Vice President, Regulatory on a consulting basis. During the year ending December 31, 2020, we recorded share-based compensation of $450,000 associated with Company milestone-based vesting of the Cancer Revolution, LLC warrants. We expect to record $124,000 of share-based compensation for time-based vesting over the next three years and another $300,000 of share-based compensation based on performance-based vesting.

On January 29, 2018, the Company entered into an agreement with a consultant whereby the Company agreed to grant warrants to purchase up to 6,000 shares of the Company's common stock at an exercise price of $5.00 per share in consideration of services valued at $30,000 provided to the Company. At September 30, 2021, the Company has not issued these warrants.

2018 Equity Incentive Plan

The Company’s board of directors and stockholders approved and adopted the Company’s 2018 Equity Incentive Plan (“2018 Plan”), which became effective 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 were originally reserved for issuance 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 is automatically increased on January 1 of each calendar 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, 2020 and 2021, the number of shares of common stock reserved for issuance under the 2018 Plan was increased by an aggregate of 963,192 and 2,155,884 shares, respectively. As of September 30, 2021, a total of 1,750,633 shares of common stock remain available for issuance under the 2018 Plan.

2018 Employee Stock Purchase Plan

The Company’s board of directors and stockholders approved and adopted the Company’s 2018 Employee Stock Purchase Plan (“ESPP”), which became effective on April 3, 2018. The ESPP has not yet been utilized as a benefit available to our employees. The ESPP authorizes the issuance of 208,500 shares of the Company’s common stock pursuant to purchase rights that may be granted to our eligible employees. The number of shares of common stock reserved for issuance under the ESPP is automatically increased on January 1 of each calendar year, beginning on January 1, 2019, by 2% 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 ESPP. The administrator of the ESPP determined not to increase the number of shares reserved for issuance under the ESPP on January 1, 2021.

Stock Options

As of September 30, 2021, the Company had outstanding stock options to purchase 8,682,808 shares of common stock that have been granted to various executives, employees, directors, and independent contractors. These options 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 $0.015 to $9.80 per share. The per-share fair values of these options range from $0.015 to $7.93, based on Black-Scholes-Merton pricing models with the following assumptions:

Expected term (in years):		10
Risk-free rate:		0.07% – 2.63%
Volatility:		75.98% – 88.38%
Dividend yield:		0%

During the nine-month period ended September 30, 2021, the Company (i) granted stock options to purchase an aggregate of 2,519,628 shares of the Company's common stock with exercise prices ranging from $2.72 to $7.22 per share to executives, employees, board members, and consultants, (ii) cancelled options to purchase 10,000 shares of common stock at an exercise price of $7.22 per share due to the termination of a former employee, and (iii) issued 670,889 shares of the Company's common stock upon the exercise of options held by consultants, a former board member, and a former executive, with exercise prices ranging from $0.015 to $2.15 per share.

During the year ended December 31, 2020, the Company (i) granted stock options to purchase an aggregate of 2,466,529 shares of the Company's common stock with exercise prices ranging from $1.28 to $4.42 per share to executives, employees, board members, and consultants, (ii) cancelled options to purchase 327,640 shares of common stock at exercise prices ranging from $5.29 to $9.80 due to expiration of options and separation of a former executive, and (iii) issued 1,277,743 shares of the Company's common stock upon the exercise of options held by former board members and a former executive with exercise prices ranging from $0.015 to $2.15 per share.

The weighted average remaining contractual term for the outstanding options at September 30, 2021 and December 31, 2020 is 7.84 and 7.06 years, respectively.

Stock option activity for the nine months ended September 30, 2021, and year ended December 31, 2020 is as follows:

	*Number of*			*Weighted Average*
	*Shares*			*Exercise Price*
Outstanding at January 1, 2020		5,982,923		$	2.66
Options granted		2,466,529			2.87
Options exercised		(1,277,743	)		1.03
Options expired		(327,640	)		8.31
Outstanding at December 31, 2020		6,844,069		$	2.81
Options granted		2,519,628			4.26
Options exercised		(670,889	)		1.01
Options expired or cancelled		(10,000	)		7.22
Outstanding at September 30, 2021		8,682,808		$	3.36
Vested or expected to vest at September 30, 2021		349,239			2.91
Exercisable at September 30, 2021		4,894,439		$	3.10

Share-Based Compensation

For the nine months ended September 30, 2021, the Company's total share-based compensation was approximately $2.5 million, nearly all of which represents the vesting of options and warrants issued to service providers, executives, employees, and board members. As of September 30, 2021, the Company’s total compensation cost related to non-vested time-based stock option awards and warrants granted to executives, employees, board members, and service providers and not yet recognized was approximately $9.7 million. The Company expects to record this stock-based compensation expense over the next three years using a graded vesting method. As of September 30, 2021, the weighted average term over which these expenses are expected to be recognized is 2.23 years.

As of September 30, 2021, there are no performance-based stock option awards outstanding and one performance-based warrant outstanding issued to a service provider. The Company’s total compensation cost related to the non-vested performance-based warrant not yet recognized was approximately $300,000. The entirety of this warrant may be recognized and recorded upon the achievement of certain milestones.

Note 5 - Related Party Transactions

Introgen Research Institute

Introgen Research Institute (“IRI”) is a Texas-based technology company, currently affiliated with Rodney Varner, our President, Chief Executive Officer, and director. In April 2009, prior to Mr. Varner becoming an officer and director of our Company which occurred in August 2012, we entered into an Assignment and Collaboration Agreement with IRI, which provides 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, an advisor to the Company, on April 19, 2018. The Company agreed to initially pay Mr. Ly $175,000 annually, as adjusted from time-to-time as determined by the Company, for strategic consulting services. The Company paid Mr. Ly an aggregate of $28,500 during the three months ended September 30, 2021, for strategic services. In April 2020, the Company issued Cancer Revolution LLC, an entity owned by Mr. Ly, a warrant to purchase up to 500,000 shares of the Company's common stock at an exercise price of $2.27 per share, which vests based on the achievement of certain Company milestones. On February 10, 2021, the Company issued an option to Mr. Ly to purchase up to 100,000 shares of the Company's common stock at an exercise price of $7.72 per share, which vests ratably over 12 months through February 2022. On September 15, 2021, Mr. Ly exercised options to purchase 56,815 shares of common stock at $0.965 per share.

Note 6 - Commitments and Contingencies

Leases

On April 16, 2018, the Company executed a space utilization agreement with the Board of Regents of the University of Texas System to establish and lease offices at the Dell Medical School in Austin, Texas. On March 23, 2021, the Company was informed by Dell Medical School that the University of Texas desired to use the space and not renew the space utilization agreement. The lease terminated on April 30, 2021, and our employees all currently work virtually while we evaluate future space needs post the COVID-19 pandemic.

On April 16, 2018, the Company executed a service agreement with CIC Innovation Communities, LLC to establish and lease offices at the Cambridge Innovation Center in Cambridge, Massachusetts. On April 1, 2020, the Company provided notice of cancellation of its lease effective as of April 30, 2020.

Commitments

MD Anderson Cancer Center

The Company entered into a clinical study agreement with the MD Anderson, to administer the Company’s Phase 1/2 clinical trial, combining REQORSA and Tarceva in Stage 4 lung cancer patients. The trial was expected to run through the end of 2018 with a projected total cost of approximately $2 million. Payments are due and payable when invoiced throughout the clinical trial period. The agreement may be terminated at any time. In 2020, the Company received Fast Track Designation ("FTD") from the FDA for its Acclaim-1 trial which combines REQORSA plus Tagrisso in patients with stage III or IV NSCLC with EGFR mutations that progressed after treatment with Tagrisso. Given the FTD and with Tagrisso now considered a new standard of care in the U.S. for NSCLC with an EGFR mutation, the Company is no longer enrolling patients in its ONC-002 study and, in June 2021, initiated its Acclaim-1 trial and plans to initiate its Acclaim-2 trial by the end of 2021.

In July 2018, the Company entered into a two-year sponsored research agreement with MD Anderson to sponsor preclinical studies focused on the combination of REQORSA with an immunotherapy with a projected total cost of approximately $2 million. Payments are due and payable when invoiced throughout the clinical trial period. The agreement may be terminated at any time. This agreement has been extended through May 2022.

In 2011, the Company agreed to assume certain contractual and other obligations of IRI in consideration for the sublicense rights, expertise, and assistance associated with certain technologies and intellectual property originally licensed to another party under a 1994 License Agreement with MD Anderson (“Original MD Anderson License Agreement”). These technologies and intellectual property were later sublicensed to IRI (the “IRI Sublicense”). The Company also agreed to pay royalties of 1% on sales of certain licensed products for a period of 21 years following the termination of the later of the Original MD Anderson License Agreement and the IRI Sublicense. The Company assumed patent prosecution costs and an annual minimum royalty of $20,000 payable to the National Institutes of Health.

On March 3, 2021, the Company entered into an amendment (the “MD License Amendment”) to the Patent and Technology License Agreement dated May 4, 2020, with MD Anderson. The MD License Amendment grants the Company a worldwide, exclusive, sublicensable license to an additional portfolio of six patents and one patent application and related technology for methods for treating cancer by administration of a TUSC2 therapy in conjunction with EGFR inhibitors or other anti-cancer therapies in patients predicted to be responsive to TUSC2 therapy. Pursuant to the MD License Amendment, the Company agreed to (i) pay annual maintenance fees ranging from the mid five figures to the low six figures, (ii) total milestone payments of $6,150,000, (iii) a one-time fee in the mid five figures and (iv) certain patent related expenses.

National Institutes of Health

Our $191,393 payment obligation to the National Institutes of Health (“NIH”) represented a current obligation, of which $15,393 of 2016 patent prosecution costs were paid in the fourth quarter of 2016 and $176,000 was included in accounts payable at December 31, 2016 (consisting of accrued annual royalties of $140,000 and patent costs of $36,000). During the first quarter of 2017, we modified the terms of our accrued royalty obligation to NIH. Under the modified agreement, NIH agreed to extinguish $120,000 of the accrued royalties payable to it in consideration of payment by us of (i) accrued patent costs of $36,000, (ii) a royalty payment of $20,000, and (iii) a contingent payment of $240,000, increasing by $20,000 per year starting in 2018, to be paid upon our receipt of FDA approval. The payments for the patent costs of $36,000 and royalties of $20,000 were paid during the second quarter of 2017.

As a result of our modified agreement with the NIH, we have recognized the exchange of the $120,000 fixed obligation for the $240,000 contingent obligation as a $120,000 reduction to intellectual property expense (classified within general and administrative expense) during the first quarter of 2017. The $240,000 contingent obligation, which increases annually by $20,000 and is $300,000 as of December 31, 2020, will be recognized when we obtain regulatory approval (the event that triggers the payment obligation).

University of Pittsburgh

Pursuant to the Exclusive License Agreement dated February 11, 2020 by and between the Company and the University of Pittsburgh, the Company agreed to pay (i) an initial licensing fee of $25,000, (ii) annual maintenance fees of $25,000 for the first three years and $40,000 for each subsequent year following the first anniversary of the agreement, (iii) royalties ranging from 1.5% to 3% of net sales of licensed technologies, (iv) an annual minimal royalty payment of $250,000 per year beginning in the year of the first commercial sale of licensed technology, (v) a share of non-royalty sublicense income of 20%, and (vi) an aggregate of $3,975,000 in milestone payments. Unless earlier terminated pursuant to its terms, the agreement expires upon the later of (i) 20 years after the first commercial sale of the licensed technology thereunder and (ii) expiration of the last valid claim under the patent rights.

Contingencies

From time to time, we may become subject to threatened and/or asserted claims arising in the ordinary course of our business. Management is not aware of any matters, either individually or in the aggregate, that are reasonably likely to have a material impact on our financial condition, results of operations or liquidity.

Note 7 - 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 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. Through March 31, 2021, the Company had not experienced any material impact on its financial results or operations as a result of the COVID-19 pandemic. Since June 2021, the Company has experienced delays in engaging clinical sites as a result of a backlog of clinical trial protocols requiring review created by an accumulation of protocols while clinical trials have been widely disrupted during the pandemic and workforce shortages that have been impacting the U.S. economy in general. The Company continues to monitor the impact of the COVID-19 pandemic closely.

Note 8 - Subsequent Events

Share Issuance

On October 1, 2021, the Company issued 5,000 shares of its common stock to the Chairman of our Scientific Advisory Board in consideration for services.

Departure of Chief Operating Officer and Executive Vice President

Effective as of October 15, 2021, Michael Redman’s employment with the Company as Chief Operating Officer and Executive Vice President of the Company was terminated.

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

You should read the following discussion and analysis of our financial condition and results of operations together with our interim condensed financial statements and the related notes appearing elsewhere in this Quarterly Report on Form 10-Q. In addition to historical information, this discussion and analysis contains forward-looking statements that involve risks, uncertainties and assumptions. Our actual results may differ materially from those discussed below. Factors that could cause or contribute to such differences include, but are not limited to, those identified below, and those discussed in the section titled “Risk Factors” included in our Annual Report on Form 10-K for the fiscal year ended December 31, 2020, as may be amended, supplemented or superseded from time to time by other reports we file with the SEC. All amounts in this report are in U.S. dollars, unless otherwise noted.

Overview

We are a clinical stage gene therapy company focused on developing life-changing treatments for cancer and diabetes. Our lead cancer drug candidate, REQORSA™ Immunogene therapy drug (sometimes referred to as GPX-001) , is being developed initially to treat non-small cell lung cancer ("NSCLC"). The active agent in REQORSA is a TUSC2 gene expressing plasmid that is encapsulated in a DOTAP cholesterol lipid nanoparticle. TUSC2 is a tumor suppressor gene which has both tumor killing (via apoptosis) and immunomodulatory effects. We utilize our novel proprietary ONCOPREX® Nanoparticle Delivery System to deliver the TUSC2 gene expressing plasmid to cancer cells. The TUSC2 gene is one of a series of genes whose therapeutic use is covered by our exclusive worldwide licenses from The University of Texas MD Anderson Cancer Center ("MD Anderson").

Our Acclaim-1 clinical trial is a Phase 1/2 study using a combination of REQORSA with AstraZeneca PLC’s Tagrisso® in patients with late-stage NSCLC with activating epidermal growth factor receptor ("EGFR") mutations, whose disease progressed after treatment with Tagrisso. In January 2020, we received U.S. Food and Drug Administration ("FDA") Fast Track Designation for use of REQORSA in combination with Tagrisso in patients with stage III or IV NSCLC with EGFR mutations that progressed after treatment with Tagrisso. In June 2021, we announced that the FDA had reviewed and confirmed all comments have been addressed regarding our Acclaim-1 clinical trial protocol and that we had engaged our first clinical site for our Acclaim-1 trial. This clinical trial is open for enrollment of patients, but we have not yet enrolled our first patient. We believe that the first patient will be enrolled in the fourth quarter of 2021, or the first quarter of 2022. We also believe that the rate of patient enrollment may increase as a result of the addition of clinical trial sites and as COVID-19 related site delays improve.

Our Acclaim-2 clinical trial is designed as a Phase 1/2 study using a combination of REQORSA with Merck & Co.’s Keytruda® in late stage NSCLC patients. Our trial design is informed by input from global leaders in lung cancer treatment. On October 1, 2021 we filed the Acclaim-2 protocol with the FDA as an amendment to our IND. We recently received FDA comments on the protocol to which we are responding and plan to discuss the Agency’s comments on the Phase 2 portion of the protocol prior to Phase 2 initiation. We believe any revisions to the protocol as a result of this FDA interaction will result in an optimized development plan. We expect that we will initiate the Phase 1 portion of the Acclaim-2 clinical trial by the end of calendar year 2021 and we will finalize the Phase 2 portion of the trial shortly thereafter, and in any event, well before the expected commencement of the Phase 2 study.

Oncology Platform

Diabetes Gene Therapy

Our pre-clinical diabetes gene therapy, also referred to as GPX-002, was discovered by lead researcher Dr. George Gittes, at the Rangos Research Center at the University of Pittsburgh Medical Center Children’s Hospital. This potential treatment is designed to work 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. The therapy utilizes a procedure in which an adeno-associated virus vector delivers Pdx1 and MafA genes to the pancreas.

JOBS Act

On April 5, 2012, the Jumpstart Our Business Startups Act of 2012 (the “JOBS Act”) was enacted. Section 107 of the JOBS Act 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 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 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.

Notwithstanding the foregoing, subject to certain conditions set forth in the JOBS Act, as an “emerging growth company,” we intend to rely on certain exemptions, including, without limitation, the exemption from the requirements (i) to provide an auditor’s attestation report on our system of internal controls over financial reporting pursuant to Section 404(b) of the Sarbanes-Oxley Act of 2002, as amended, and (ii) to comply with any requirement that may be adopted by the Public Company Accounting Oversight Board regarding mandatory audit firm rotation or a supplement to the auditor’s report providing additional information about the audit and the financial statements, known as the auditor discussion and analysis. We will remain an “emerging growth company” until the earliest of (i) the last day of the fiscal year in which we have total annual gross revenues of $1.07 billion or more; (ii) the last day of our fiscal year following the fifth anniversary of the date of our initial public offering; (iii) the date on which we have issued more than $1.0 billion in nonconvertible debt during the previous three years; or (iv) the date on which we are deemed to be a large accelerated filer under the rules of the SEC.

Critical Accounting Policies and Significant Judgments and Estimates

Our condensed financial statements have been prepared in accordance with generally accepted accounting principles in the U.S. ("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, and the reported amounts of 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 contract research, manufacturing, and testing 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 condensed balance sheets and within research and development expense in the condensed statements 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 in any of our clinical trials may vary from our estimates and could result in our 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 September 30, 2021. 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.

Off-Balance Sheet Arrangements; Commitments and Contractual Obligations

As of September 30, 2021, we did not have any off-balance sheet arrangements that have or are reasonably likely to have a current or future effect on our financial condition, revenues, expenses, results of operations, liquidity, capital expenditures or capital resources nor did we have any commitments or contractual obligations.

Recently Issued Accounting Pronouncements

A description of recently issued accounting pronouncements that may potentially impact our financial position and results of operations is disclosed in Note 2 to our unaudited condensed financial statements appearing elsewhere in this Quarterly Report on Form 10-Q.

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 the production and storage of supplies for engineering purposes and storage and usage of clinical supplies, including waste created in the process of producing clinical materials, spoilage, and testing of clinical materials;
	•	costs related to the use of contract manufacturers, manufacturing consultants, testing organizations, cold-storage facilities, and logistics service providers;
	•	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 future product candidates into and through clinical trials, 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, and limited contracted partners. We may never succeed in achieving regulatory approval for any of our current or future 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 product candidates, if at all.

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 five-year life.

Results of Operations

Comparison of the Three and Nine Months Ended September 30, 2021 and 2020

The following summarizes our results of operations for the three and nine months ended September 30, 2021 and 2020.

Research and Development Expense

Research and development ("R&D") expense for the three months ended September 30, 2021, was $1,431,999 as compared to $1,350,016 for the three months ended September 30, 2020. The increase of $81,983, or 6%, is due primarily to increase in R&D headcount and clinical strategy expenses for setup and preparation of our Acclaim-1 and Acclaim-2 trials.

R&D expense for the nine months ended September 30, 2021, was $5,127,419 as compared to $4,983,530 for the nine months ended September 30, 2020. The increase of $143,889, or 3%, is primarily due to increase in R&D headcount, increases manufacturing and testing costs of REQORSA, and advancements in preparation for our Acclaim-1 and Acclaim-2 trials. Equity-based compensation associated with R&D personnel, a non-cash expense, accounted for significant amount of expenses for the nine months ended September 30, 2020, due to a larger than normal share-based compensation expense in 2020 associated with a one-time accelerated vesting of options held by a former R&D executive pursuant to his separation agreement. Excluding equity-based compensation for R&D personnel, R&D expense was $4,795,983 and $2,823,954 for the nine months ended September 30, 2021, and 2020, respectively. The increase of $1,972,029, or 70%, is primarily due to (i) major advancements in our manufacturing programs manufacturing and testing drug product for our Acclaim-1 and Acclaim-2 clinical trials, (ii) increased usage of third-parties, including CROs, to setup clinical trial electronic data systems for our Acclaim-1 clinical trial and to develop clinical strategies for our Acclaim-1 and Acclaim-2 clinical trials, and (iii) significant increase in R&D personnel to support our Acclaim-1 and Acclaim-2 trials. We anticipate that these R&D activities will continue throughout 2021 and thereafter and will continue to include costs related to the ongoing support of our Acclaim-1 and Acclaim-2 clinical trials.

General and Administrative Expense

General and administrative ("G&A") expense for the three months ended September 30, 2021, was $2,000,437 as compared to $1,421,863 for the three months ended September 30, 2020. The increase of $578,574, or 41%, is primarily due to increase in G&A headcount and professional fees, insurance premiums, and equity-based compensation for employees and consultants to support the overall growth of the Company from 12 full-time employees to 16 full-time employees during the period.

G&A expense for the nine months ended September 30, 2021, was $8,774,844 as compared to $7,731,550 for the nine months ended September 30, 2020. The increase of $1,043,294, or 13%, is due to increase in G&A headcount, accrual of PTO and employee bonuses due to new PTO policies and implementation of a total rewards strategy for recruitment and retention of employees, increases in insurance premiums, and increases in equity-based compensation for employees and consultants to support the overall growth of the company from 10 full-time employees to 16 full-time employees during the nine months ended September 30, 2021.

Interest Income. Interest income was $1,060 and $2,650 for the three months ended September 30, 2021 and 2020, respectively, a decrease of $1,590, or 60%. Interest income was $4,146 and $17,467 for the nine months ended September 30, 2021 and 2020, respectively, a decrease of $13,321, or 76%. The decreases associated with interest income for the three and nine months ended September 30, 2021 were due to changes in the cash balances associated with money market instruments.

Depreciation Expense. Depreciation expense was $6,489 and $5,714 for the three months ended September 30, 2021 and 2020, respectively, an increase of $775, or 14%. Depreciation expense was $15,579 and $16,843 for the nine months ended September 30, 2021 and 2020, respectively, a decrease of $1,264, or 8%. The changes in associated depreciation expense for the three and nine months ended September 30, 2021, were due to the timing of purchases of computer equipment for new employees.

Liquidity and Capital Resources

From inception through September 30, 2021, we have never generated revenue from product sales and have incurred net losses in each year. As of September 30, 2021, we had an accumulated deficit of $72,335,925. We have funded our operations primarily through the sale and issuance of capital stock. For the year ended December 31, 2020, we sold an aggregate of 16,697,884 shares of common stock for total net proceeds of $34,493,423 pursuant to registered direct offerings and issued 7,104,524 shares of common stock upon the exercise of warrants and options for gross proceeds of $3,857,886. During the nine months ended September 30, 2021, we sold an aggregate of 4,000,000 shares of common stock for total net proceeds of $23,192,500 pursuant to a registered direct offering and issued 670,889 shares of common stock upon the exercise of options for gross proceeds of $677,912.

As of September 30, 2021, we had $42,020,527 in cash and cash equivalents.

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 or 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, which include conducting our Acclaim-1 and our Acclaim-2 clinical trials. Acclaim-1 was initiated in June 2021 with the FDA having reviewed and confirmed all comments had been addressed regarding the protocol with respect to such trial and our engagement of our first clinical site. The Acclaim-1 trial is open for enrollment at this site but we have not yet enrolled our first patient. We believe that the first patient will be enrolled in the fourth quarter of 2021, or the first quarter of 2022. On October 1, 2021, we filed the Acclaim-2 protocol with the FDA as an amendment to our IND. We recently received FDA comments on the protocol to which we are responding and plan to discuss the Agency’s comments on the Phase 2 portion of the protocol prior to Phase 2 initiation. We believe any revisions to the protocol as a result of this FDA interaction will result in an optimized development plan. We expect that we will initiate the Acclaim-2 clinical trial by the end of 2021. 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 rights to others 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 curtail or cease our operations. 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.

Based on our current cash and cash equivalents, we estimate that we will be able to fund our expenditure requirements for our current operations and planned clinical trial activities into 2024. We have based these estimates on assumptions that may prove to be wrong, and we could utilize our available capital resources sooner than we currently plan due to incorrect assumptions or due to a decision to expand our activities beyond those currently planned. We also have been experiencing delays related to COVID-19 with respect to the launch of our Acclaim-1 and Acclaim-2 clinical trials. Specifically, we have experienced delays in engaging clinical sites as a result of a backlog of clinical trial protocols requiring review created by an accumulation of protocols while clinical trials have been widely disrupted during the pandemic and workforce shortages that have been impacting the U.S. economy in general. Although, continued delays will enable us to fund our expenditure requirements for our current operations and planned clinical trial activities longer, we would not be advancing our clinical trials as anticipated and utilizing our available capital resources to support our operations only.

The following table sets forth the primary sources and uses of cash and cash equivalents during the nine months ended September 30, 2021 and 2020:

	Nine Months Ended September 30,
	2021			2020
Net cash used in operating activities	$	(11,066,850	)	$	(10,043,034	)
Net cash provided by investing activities		89,781			4,415
Net cash provided by financing activities		25,677,911			29,094,513
Net increase in cash and cash equivalents	$	14,700,842		$	19,055,894

Cash used in operating activities

Net cash used in operating activities was $11,066,850 and $10,043,034 for the nine months ended September 30, 2021 and 2020, respectively. The $1,023,816, or 10%, increase in net cash used in operating activities during the nine months ended September 30, 2021, was due to us increasing headcount and advancing manufacturing and clinical programs in anticipation of our Acclaim-1 and Acclaim-2 clinical trials.

Cash used in investing activities

Net cash provided by investing activities was $89,781 and $4,415 for the nine months ended September 30, 2021 and 2020, respectively. This increase of $85,366, or 1934%, was primarily due to timing of manufacturing programs to develop and test REQORSA and patent prosecution costs related to defending our technologies. Investments in property and equipment were negligible between the nine months ended September 30, 2021 and 2020. Investments in intellectual property was $70,777 greater for the nine months ended September 30, 2020, than the nine months ended September 30, 2021 due to patent prosecution costs related to the acquisition of our diabetes technology in the first half of 2020. Reductions in R&D materials was $20,540 greater for the nine months ended September 30, 2020 than the nine months ended September 30, 2021, and was due to timing of quality testing of REQORSA in preparation for our Acclaim-1 and Acclaim-2 clinical trials.

Cash provided by financing activities

Net cash provided by financing activities was $25,677,911 and $29,094,513 during the nine months ended September 30, 2021 and 2020, respectively. The decrease of $3,416,602, or 12%, in net cash provided by financing activities was due to our selling of more common stock in capital raising activities and greater option and warrant exercises during the nine months ended September 30, 2020 compared to the nine months ended September 30, 2021.

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

Evaluation of 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 September 30, 2021. 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. Based on the evaluation of our disclosure controls and procedures as of September 30, 2021, 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.

Due to our size and nature, segregation of all conflicting duties may not always be possible and may not be economically feasible. However, to the extent possible, the initiation of transactions, the custody of assets and the recording of transactions should be performed by separate individuals. Management evaluated the impact of our failure to maintain effective segregation of duties on our assessment of our internal control over financial reporting and has concluded that the control deficiency represents a material weakness.

In response to the material weakness described above, during the quarter ended September 30, 2021, we performed additional analysis and other post-closing procedures to ensure our financial statements were prepared in accordance with GAAP. Accordingly, we believe that the financial statements included in this report fairly present, in all material respects, our financial condition, results of operations and cash flows for the periods presented.

Remediation Plans

Our management has engaged in and is continuing to be engaged in efforts to remediate the control deficiency that led to the material weakness. The remediation plan includes implementing the following steps:

•

new accounting software, processes, and workflows to further segregate duties among limited accounting staff;

•

specific review procedures, including the added involvement of our General Counsel to review all accounting transactions following a given period in an effort to enhance accuracy of reporting;

•

specific review procedures, including the added involvement of our manufacturing staff to enhance controls associated with the reporting of inventory values;

•

the formation of a formal Disclosure Committee that has oversight responsibility for the accuracy and timeliness of disclosures made by us through the establishment of controls and procedures and the monitoring of their integrity and effectiveness; and

•

additional hiring of accounting staff to further segregate accounting responsibilities.

We plan to have our enhanced review procedures and documentation standards in place and operating by the end of 2021. Our goal is to remediate the material weakness by the end of 2022, subject to there being sufficient opportunities to conclude, through testing, that the enhanced controls are operating effectively.

Changes in Internal Control over Financial Reporting

During the quarter ended September 30, 2021, management continued to implement certain remediation measures to improve our internal controls over financial reporting and to remediate previously identified material weaknesses. However, there were no changes in our internal control over financial reporting that occurred during the quarter ended September 30, 2021, 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. Management recognizes that any controls and procedures, no matter how well conceived and operated, can provide only reasonable, not absolute, assurance that the objectives of the control system are met, and management necessarily applies its judgment in evaluating the cost-benefit relationship of possible controls and procedures.

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

During the three months ended September 30, 2021, we issued and sold the following unregistered securities:

	1)	On July 1, 2021, we issued 5,000 shares of our common stock to a consultant in consideration for services during the three months ended September 30, 2021.

	2)	On July 1, 2021, we issued a warrant to purchase up to 25,000 shares of our common stock at an exercise price of $3.36 per share, the closing price of the common stock on the date the warrant was issued, to a consultant in consideration for services.

The foregoing issuance of securities was not registered under the Securities Act or the securities laws of any state, and the securities were offered and issued in reliance on the exemption from registration under the Securities Act afforded by Section 4(a)(2).

Item 3. Defaults Upon Senior Securities

None.

Item 4. Mine Safety Disclosures

Not applicable.

Item 5. Other Information

None.

Item 6. Exhibits

INDEX TO EXHIBITS

Exhibit Number		Description of Exhibit

10.1*		Form of Warrant Agreement, dated as of July 1, 2021.

10.2		Offer Letter between Genprex, Inc. and Mark S. Berger, M.D. dated September 27, 2021 (Incorporated by reference to Exhibit 10.1 to the Company’s Current Report on Form 8-K filed with the SEC on September 28, 2021).

10.3		Offer Letter between Genprex, Inc. and Hemant Kumar, PhD. dated September 27, 2021 (Incorporated by reference to Exhibit 10.3 to the Company’s Current Report on Form 8-K filed with the SEC on September 28, 2021).

10.4+		Option Award Agreement between Genprex, Inc. and Mark S. Berger, M.D. dated September 27, 2021 (Incorporated by reference to Exhibit 10.2 to the Company’s Current Report on Form 8-K filed with the SEC on September 28, 2021).

10.5+		Option Award Agreement between Genprex, Inc. and Hemant Kumar, PhD dated September 27, 2021 (Incorporated by reference to Exhibit 10.4 to the Company’s Current Report on Form 8-K filed with the SEC on September 28, 2021).

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*		Inline XBRL Instance Document.

101.SCH*		Inline XBRL Taxonomy Extension Schema Document.

101.CAL*		Inline XBRL Taxonomy Extension Calculation Linkbase Document.

101.DEF*		Inline XBRL Taxonomy Extension Definition Linkbase Document.

101.LAB*		Inline XBRL Taxonomy Extension Label Linkbase Document.

101.PRE*		Inline XBRL Taxonomy Extension Presentation Linkbase Document.

104*		Cover Page Interactive Data File - the cover page from the Registrant’s Quarterly Report on Form 10-Q for the quarter ended September 30, 2021, is formatted in Inline XBRL.

* Filed herewith.

+ Indicates a management contract or any compensatory plan, contract or arrangement.

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: November 15, 2021	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)

SEC Form 10-Q filed by Genprex, Inc.