Genprex, Inc 10-K for FY2022

Genprex, Inc. (GNPX)

10-K 2023-03-31 For: 2022-12-31

Added on April 12, 2026

About this 10-K

Genprex, Inc filed this 10-K on March 31, 2023, covering the fiscal year ended December 31, 2022 (FY2022).

Headline figures

Fiscal year ended December 31, 2022, as reported in this filing, compared with the same period a year earlier where the filing states it.

Revenue: $0; compared with $0 a year earlier
Net loss: $23.74M; compared with a net loss of $20.66M a year earlier

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Delaware	90-0772347
(State or other jurisdiction of incorporation or organization)	(I.R.S. Employer Identification Number)

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

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

		Page
PART I		2
Item 1.	Business	2
Item 1A.	Risk Factors	46
Item 1B.	Unresolved Staff Comments	76
Item 2.	Properties	76
Item 3.	Legal Proceedings	76
Item 4.	Mine Safety Disclosures	76

PART II		77
Item 5.	Market for Registrant’s Common Equity, Related Stockholder Matters and Issuer Purchases of Equity Securities	77
Item 6.	[Reserved]	77
Item 7.	Management’s Discussion and Analysis of Financial Condition and Results of Operations	78
Item 7A.	Quantitative and Qualitative Disclosures About Market Risk	85
Item 8.	Financial Statements and Supplementary Data	85
Item 9.	Changes in and Disagreements With Accountants on Accounting and Financial Disclosure	85
Item 9A.	Controls and Procedures	86
Item 9B.	Other Information	87
Item 9C.	Disclosure Regarding Foreign Jurisdictions that Prevent Inspections	87

PART III		88
Item 10.	Directors, Executive Officers and Corporate Governance	88
Item 11.	Executive Compensation	88
Item 12.	Security Ownership of Certain Beneficial Owners and Management and Related Stockholder Matters	88
Item 13.	Certain Relationships and Related Transactions, and Director Independence	88
Item 14.	Principal Accountant Fees and Services	88

PART IV		88
Item 15.	Exhibits and Financial Statement Schedules	88
Item 16.	Form 10-K Summary	92

SIGNATURES		93

FINANCIAL STATEMENTS		F-1

Dose Level		Drug Doses
1		Tarceva (100 mg/day) + REQORSA (0.045 mg/kg)
2		Tarceva (100 mg/day) + REQORSA (0.060 mg/kg)
3		Tarceva (150 mg/day) + REQORSA (0.045 mg/kg)
4		Tarceva (150 mg/day) + REQORSA (0.060 mg/kg)

	●	Increased c-peptide levels (p<0.05);
	●	Improved glucose tolerance compared to baseline (p<0.05) with one demonstrating reestablished normoglycemia; and

	●	Extensive and diverse internal expertise;
	●	Customized chemistry, manufacturing and controls ("CMC") strategy for accelerated development;
	●	Risk assessment and remediation for FDA submissions;
	●	Novel and proprietary manufacturing processes;
	●	Integrated global Good Manufacturing Practices ("cGMP" or "GMP") manufacturing network; and
	●	Management of supply chain for business continuity.

	●	We will require substantial additional funding, which may not be available to us on acceptable terms, or at all, and, if not so available, may require us to delay, limit, reduce or cease our operations.
	●	We have never been profitable, we have no products approved for commercial sale, and to date we have not generated any revenue from product sales. As a result, our ability to reduce our losses and reach profitability is unproven, and we may never achieve or sustain profitability.

	●	We have a limited operating history and we expect a number of factors to cause our operating results to fluctuate on an annual basis, which may make it difficult to predict our future performance.
	●	Our ability to utilize our net operating loss carryforwards may be limited, resulting in income taxes sooner than currently anticipated.

	●	Our success depends greatly on the success of our development of REQORSA for the treatment of NSCLC and SCLC, and our other product candidates, including GPX-002 and GPX-003 for the treatment of diabetes.
	●	If we are unable to secure contract manufacturers with capabilities to produce the products that we require, we could experience delays in conducting our planned clinical trials.
	●	Negative public opinion and increased regulatory scrutiny of gene therapy and genetic research may damage public perception of our current and potential product candidates or adversely affect our ability to conduct our business or obtain regulatory approvals for our current and potential product candidates.
	●	Conducting successful clinical studies may require the enrollment of large numbers of patients, and suitable patients may be difficult to identify and recruit.
	●	Delays in the commencement, enrollment and completion of clinical trials could result in increased costs to us and delay or limit our ability to obtain regulatory approval for REQORSA and other current or future product candidates.
	●	Fast track designation of our products by FDA and designation under any other FDA expedited development program may not actually lead to a faster development or regulatory review or approval process, nor will it assure FDA approval of our product candidates.

	●	We may not be able to obtain or maintain orphan drug designation or exclusivity for our product candidates.
	●	A product candidate can fail at any stage of preclinical and clinical development.
	●	REQORSA®, GPX-002, GPX-003, and any other product candidate we advance through clinical trials may not have favorable results in later clinical trials or receive regulatory approval. Even if we complete the necessary clinical trials, we cannot predict when, or if, we will obtain regulatory approval to commercialize our product candidates, and the approval may be for a narrower indication than we seek.
	●	Even if we obtain regulatory approval of our current and future product candidates, the products may not gain market acceptance among physicians, patients, hospitals, treatment centers, third-party payors and others in the medical community.
	●	REQORSA®, GPX-002, GPX-003, and other current or future product candidates may have undesirable side effects that may delay or prevent marketing approval, or, if approval is received, require them to be taken off the market, require them to include safety warnings or otherwise limit their sales.
	●	If a product liability claim is successfully brought against us for uninsured liabilities, or such claim exceeds our insurance coverage, we could be forced to pay substantial damage awards that could materially harm our business.
	●	Security breaches and other disruptions could compromise our information and expose us to liability, which would cause our business and reputation to suffer.
	●	Our business has been adversely affected by the coronavirus pandemic which has delayed and may continue to delay our clinical trials and has disrupted and may continue to disrupt our supply chain and may have other adverse effects on our business and operations.
	●	We face competition from other biotechnology and pharmaceutical companies, particularly those that are gene therapy companies, and our operating results will suffer if we fail to compete effectively.

	●	We cannot provide assurance that REQORSA, GPX-002, GPX-003, or any of our other current or future product candidates will receive regulatory approval, and without regulatory approval we will not be able to market them.
	●	Even if we obtain regulatory approval for our product candidates, our products will remain subject to regulatory oversight.

	●	Coverage and reimbursement may be limited or unavailable in certain market segments for REQORSA, GPX-002, GPX-003, and our other current or future product candidates, if approved, which could make it difficult for us to sell REQORSA, GPX-002, GPX-003, and our other current or future product candidates profitably.
	●	Concerns about gene therapy, genetic testing, and genetic research could result in new and/or additional government regulations and requirements that restrict or prohibit the processes we use or delay or prevent the regulatory approval of our current and potential product candidates.
	●	Healthcare legislative reform measures may have a material adverse effect on our business and results of operations.
	●	We are subject to a variety of risks associated with international operations which could materially adversely affect our business.
	●	If we fail to comply with environmental, health and safety laws and regulations, we could become subject to fines or penalties or incur costs that could have a material adverse effect on the success of our business.

	●	We rely, and expect to continue to rely, on third parties to distribute, manufacture and perform release testing for our current and future product candidates and other key materials and if such third parties do not carry out their contractual duties or meet expected deadlines, we may not be able to obtain regulatory approvals for our product candidates.
	●	We have completed and may in the future complete related party transactions that were not and may not be conducted on an arm’s length basis.
	●	Disruptions in the global economy and supply chains may have a material adverse effect on our business, financial condition and results of operations.

	●	unexpected results from pre-clinical testing and development;
	●	inability or delays in enrolling research subjects in clinical trials;

	●	the possibility that our contract manufacturers may experience failures in product production; and
	●	the possibility of termination or nonrenewal of any manufacturing agreement we may enter into.

	●	a covered benefit under its health plan;
	●	safe, effective and medically necessary;
	●	appropriate for the specific patient;
	●	cost-effective; and
	●	neither experimental nor investigational.

	●	the demand for our current and potential product candidates, if we obtain regulatory approval;
	●	our ability to set a price that we believe is fair for our products;
	●	our ability to generate revenue and achieve or maintain profitability;
	●	the level of taxes that we are required to pay; and
	●	the availability of capital.

	●	different regulatory requirements for approval of product candidates in foreign countries;
	●	reduced protection for intellectual property rights;
	●	unexpected changes in tariffs, trade barriers and regulatory requirements;
	●	economic weakness, including inflation, or political instability in particular foreign economies and markets;
	● ●	compliance with tax, employment, immigration and labor laws for employees living or traveling abroad; compliance with international data privacy laws, including GDPR;
	●	foreign currency fluctuations, which could result in increased operating expenses and reduced revenues, and other obligations incident to doing business in another country;
	●	workforce uncertainty in countries where labor unrest is more common than in the United States;
	●	production shortages resulting from any events affecting raw material supply or manufacturing capabilities abroad; and
	●	business interruptions resulting from geopolitical actions, including war and terrorism or natural disasters including earthquakes, typhoons, floods, fires and medical epidemics.

	●	increased operating expenses and cash requirements;
	●	the assumption of additional indebtedness or contingent liabilities;
	●	the issuance of our equity securities;
	●	assimilation of operations, intellectual property and products of an acquired company, including difficulties associated with integrating new personnel;
	●	difficulties in achieving anticipated cost savings, synergies, business opportunities, and growth prospects from any business combination;
	●	the diversion of our management’s attention from our existing product programs and initiatives in pursuing such a strategic merger or acquisition;
	●	retention of key employees, the loss of key personnel, and uncertainties in our ability to maintain key business relationships;
	●	risks and uncertainties associated with the other party to such a transaction, including the prospects of that party and their existing products or product candidates and marketing approvals; and
	●	our inability to generate revenue from acquired technology and/or products sufficient to meet our objectives in undertaking the acquisition or even to offset the associated acquisition and maintenance costs.

	●	inability to obtain additional funding;
	●	adverse results or delays in preclinical or clinical trials;
	● ●	reports of adverse events in other gene therapy products or clinical trials of such products; manufacturing and supply issues related to our existing or future products;
	●	any delay in filing an IND or BLA for our product candidates and any adverse development or perceived adverse development with respect to the FDA’s review of that IND or BLA;
	●	failure to develop successfully and commercialize our product candidates;
	●	failure to maintain our existing strategic collaborations or enter into new collaborations;
	●	failure by us or our licensors and strategic collaboration partners to prosecute, maintain or enforce our intellectual property rights;
	●	changes in laws or regulations applicable to our products and product candidates;
	●	inability to obtain adequate product supply for our product candidates or inability to do so at acceptable prices;
	●	adverse regulatory decisions;
	●	introduction of new products, services or technologies by our competitors;
	●	failure to meet or exceed financial projections we may provide to the public;
	●	failure to meet or exceed the financial projections of the investment community;
	●	the perception of the pharmaceutical and biotechnology industries by the public, legislatures, regulators and the investment community;
	●	announcements of significant acquisitions, strategic partnerships, joint ventures or capital commitments by us, our strategic collaboration partners or our competitors;
	●	disputes or other developments relating to proprietary rights, including patents, litigation matters and our ability to obtain patent protection for our technologies;
	●	additions or departures of key scientific or management personnel;
	●	significant lawsuits, including patent or stockholder litigation;
	●	changes in the market valuations of similar companies;
	●	sales of our common stock by us or our stockholders;
	●	trading volume of our common stock;
	●	General economic conditions in the United States and abroad; and other events or factors, many of which may be out of our control, including, but not limited to, pandemics such as COVID-19, war, or other acts of God.

	1)	On October 1, 2022, we issued an aggregate of 5,000 shares of our common stock to a consultant in consideration of services during the three months ended December 31, 2022.

	2)	On December 5, 2022, we issued an aggregate of 76,752 shares of our common stock to a consultant in consideration of services.

	3)	On December 20, 2022, we issued a warrant to purchase up to 3,000 shares of our common stock at an exercise price of $5.00 per share to a consultant in consideration for services.

	Years Ended December 31,
	2022			2021
Net cash used in operating activities	$	(17,778,964	)	$	(14,284,924	)
Net cash provided (used) in investing activities		97,731			(83,796	)
Net cash provided in financing activities		6,426			25,677,911
Net (decrease) increase in cash and cash equivalents		(17,674,807	)		11,309,191

Exhibit Number		Description of Exhibit
3.1		Amended and Restated Certificate of Incorporation of the Registrant, dated April 3, 2018, incorporated by reference to Exhibit 3.1 of the Registrant’s Current Report on Form 8-K filed on April 10, 2018.

3.2		Amended and Restated Bylaws of the Registrant, dated April 3, 2018, incorporated by reference to Exhibit 3.2 of the Registrant’s Current Report on Form 8-K filed on April 10, 2018.

4.1		Form of Common Stock Certificate of the Registrant, incorporated by reference to Exhibit 4.1 of the Registrant’s Registration Statement on Form S-1 (File No. 333-219386), as amended, originally filed on July 21, 2017.

4.2		Warrant Agreement, dated November 3, 2016, issued to Viet Ly, incorporated by reference to Exhibit 4.6 of the Registrant’s Registration Statement on Form S-1 (File No. 333-219386), as amended, originally filed on July 21, 2017.

4.3		Form of Underwriter’s Warrant Agreement, incorporated by reference to Exhibit 4.7 of the Registrant’s Registration Statement on Form S-1 (File No. 333-219386), as amended, originally filed on July 21, 2017.

4.4		Form of Common Stock Purchase Warrant, incorporated by reference to Exhibit 4.1 of the Registrant’s Current Report on Form 8-K filed on May 10, 2018.

4.5		Warrant Agreement, dated July 27, 2018, issued to Cancer Revolution, LLC, incorporated by reference to Exhibit 4.1 of the Registrant’s Current Report on Form 8-K filed on August 6, 2018.

4.6		Warrant Agreement, dated July 27, 2018, issued to Inception Capital Management, LLC, incorporated by reference to Exhibit 4.2 of the Registrant’s Current Report on Form 8-K filed on August 6, 2018.

4.7		Warrant Agreement, dated July 27, 2018, issued to Cancer Biotech, LLC, incorporated by reference to Exhibit 4.3 of the Registrant’s Current Report on Form 8-K filed on August 6, 2018.

4.8		Form of Warrant, incorporated by reference to Exhibit 10.2 of the Registrant’s Current Report on Form 8-K filed on November 22, 2019.

4.9		Warrant Agreement, dated April 24, 2020, issued to Cancer Revolution LLC, incorporated by reference to Exhibit 4.1 of the Registrant’s Current Report on Form 8-K filed on April 28, 2020.

4.10		Warrant Agreement, dated August 10, 2020, issued to Capital City Technical Consulting, Inc., incorporated by reference to Exhibit 4.11 of the Registrant’s Annual Report on Form 10-K filed on March 26, 2021.

4.11		Amended and Restated Warrant Agreement, dated August 10, 2020, issued to DABS Advanced Biotech Solutions, LLC., incorporated by reference to Exhibit 4.12 of the Registrant’s Annual Report on Form 10-K filed on March 26, 2021.

4.12		Amended and Restated Warrant Agreement, dated August 10, 2020, issued to DABS Advanced Biotech Solutions, LLC., incorporated by reference to Exhibit 4.13 of the Registrant’s Annual Report on Form 10-K filed on March 26, 2021.

4.13		Form of Securities Purchase Agreement, dated February 8, 2021, incorporated by reference to Exhibit 10.1 of the Registrant’s Current Report on Form 8-K filed on February 9, 2021.

4.14		Warrant Agreement, dated February 10, 2021, issued to Bear Creek Capital LLC, incorporated by reference to Exhibit 4.1 of the Registrant’s Quarterly Report on Form 10-Q filed on May 17, 2021.

4.15		Form of Warrant Agreement, dated as of July 1, 2021, incorporated by reference to Exhibit 10.1 of the Registrant’s Quarterly Report on Form 10-Q filed on November 15, 2021.

4.16		Warrant Agreement, dated as of July 1, 2022, issued to Bear Creek LLC, incorporated by reference to Exhibit 10.2 of the Registrant's Quarterly Report on Form 10-Q filed on August 12, 2022.

4.17		Form of Warrant, dated March 1, 2023, incorporated by reference to Exhibit 4.1 of the Registrant's Current Report on Form 8-K filed on February 27, 2023.

4.18	*	Description of Registrant's Securities.

10.1	+	Form of Indemnity Agreement, by and between the Company and its directors and officers, dated as of May 17, 2022, incorporated by reference to Exhibit 10.1 of the Registrant's Quarterly Report on Form 10-Q filed on August 12, 2022.

Exhibit Number		Description of Exhibit
10.2	+	Registrant’s 2009 Equity Incentive Plan, including Form of Notice of Stock Option Grant, and Form of Stock Option Agreement thereunder, incorporated by reference to Exhibit 10.2 of the Registrant's Registration Statement on Form S-1 (File No. 333-219386), as amended, originally filed on July 21, 2017.

10.3	+	Genprex, Inc. 2018 Equity Incentive Plan, dated April 3, 2018, including Form of Notice of Stock Option Grant, Form of Option Agreement, and Form of Notice of Exercise thereunder, incorporated by reference to Exhibit 10.3 of the Registrant’s Annual Report on Form 10-K filed April 17, 2018.

10.4	+	Genprex, Inc. 2018 Employee Stock Purchase Plan, dated April 3, 2018, incorporated by reference to Exhibit 10.4 of the Registrant’s Annual Report on Form 10-K filed April 17, 2018.

10.5	+	Genprex, Inc. Non-Employee Director Compensation Policy, dated November 2, 2018, incorporated by reference to Exhibit 10.1 of the Registrant's Current Report on Form 8-K filed on November 8, 2018.

10.6		Patent and Technology License Agreement, dated July 20, 1994, by and between the Board of Regents of the University of Texas System, The University of Texas M.D. Anderson Cancer Center and Intron Therapeutics, Inc., incorporated by reference to Exhibit 10.6 of the Registrant's Registration Statement on Form S-1 (File No. 333-219386), as amended, originally filed on July 21, 2017.

10.7		Amendment No. 3 to Patent and Technology License Agreement, dated October 4, 2001, incorporated by reference to Exhibit 10.7 of the Registrant's Registration Statement on Form S-1 (File No. 333-219386), as amended, originally filed on July 21, 2017.

10.8		Technology Sublicense Agreement, dated March 7, 2007, by and between Introgen Therapeutics, Inc., and Introgen Research Institute, Inc., incorporated by reference to Exhibit 10.8 of the Registrant's Registration Statement on Form S-1 (File No. 333-219386), as amended, originally filed on July 21, 2017.

10.9		Assignment and Collaboration Agreement, dated April 13, 2009, by and between Gensolve, Inc. and the Registrant, incorporated by reference to Exhibit 10.9 of the Registrant's Registration Statement on Form S-1 (File No. 333-219386), as amended, originally filed on July 21, 2017.

10.10		Technology License Agreement, dated February 26, 2010, by and between Introgen Research Institute, Inc. and P53, Inc., incorporated by reference to Exhibit 10.10 of the Registrant’s Registration Statement on Form S-1 (File No. 333-219386), as amended, originally filed on July 21, 2017.

10.11		Technology Sublicense Agreement, dated June 1, 2011, by and between the Registrant and Introgen Research Institute, Inc., incorporated by reference to Exhibit 10.12 of the Registrant’s Registration Statement on Form S-1 (File No. 333-219386), as amended, originally filed on July 21, 2017.

10.12		Amended Collaboration and Assignment Agreement, dated July 1, 2011, by and between Introgen Research Institute, Inc. and the Registrant, incorporated by reference to Exhibit 10.13 of the Registrant’s Registration Statement on Form S-1 (File No. 333-219386), as amended, originally filed on July 21, 2017.

10.13		Clinical Study Agreement, dated February 10, 2014, by and between The University of Texas M.D. Anderson Cancer Center and the Registrant, incorporated by reference to Exhibit 10.14 of the Registrant’s Registration Statement on Form S-1 (File No. 333-219386), as amended, originally filed on July 21, 2017.

10.14		Amendment No. 1 to Clinical Study Agreement, dated June 25, 2015, incorporated by reference to Exhibit 10.15 of the Registrant’s Registration Statement on Form S-1 (File No. 333-219386), as amended, originally filed on July 21, 2017.

10.15	+	Executive Employment Agreement, dated April 13, 2018, by and between the Registrant and Rodney Varner, incorporated by reference to Exhibit 10.16 of the Registrant’s Annual Report on Form 10-K filed on April 17, 2018.

10.16	+	Executive Employment Agreement, dated April 13, 2018, by and between the Registrant and Ryan Confer, incorporated by reference to Exhibit 10.17 of the Registrant’s Annual Report on Form 10-K filed on April 17. 2018.

Exhibit Number		Description of Exhibit
10.17		Form of Registration Rights Agreement, dated May 6, 2018, incorporated by reference to Exhibit 10.2 of the Registrant's Current Report on Form 8-K filed on May 10, 2018.

10.18	+	Consulting Agreement, dated August 13, 2018, by and between the Registrant and Viet Ly, incorporated by reference to Exhibit 10.1 of the Registrant’s Quarterly Report on Form 10-Q filed on August 14, 2018.

10.19		Form of Securities Purchase Agreement, dated November 20, 2019, incorporated by reference to Exhibit 10.1 of the Registrant’s Current Report on Form 8-K filed on November 22, 2019.

10.20		Exclusive License Agreement, dated February 11, 2020, by and between the Registrant and the University of Pittsburgh – Of the Commonwealth System of Higher Education, incorporated by reference to Exhibit 10.1 of the Registrant’s Current Report on Form 8-K filed on February 18, 2020.

10.21		Form of Securities Purchase Agreement, dated February 19, 2020, incorporated by reference to Exhibit 10.1 of the Registrant’s Current Report on Form 8-K filed on February 20, 2020.

10.22	+	Executive Employment Agreement, dated March 12, 2020, by and between the Registrant and Catherine Vaczy, incorporated by reference to Exhibit 10.1 of the Registrant’s Current Report on Form 8-K filed on March 23, 2020.

10.23	+	Executive Employment Agreement, dated March 12, 2020, by and between the Registrant and Michael Redman, incorporated by reference to Exhibit 10.2 of the Registrant’s Current Report on Form 8-K filed on March 23, 2020.

10.24	++	Amendment No. 1 to Patent and Technology License Agreement, dated March 3, 2021, by and between the Registrant and The University of Texas M.D. Anderson Cancer Center, incorporated by reference to Exhibit 10.29 of the Registrant’s Annual Report on Form 10-K filed on March 26, 2021.

10.25	+	First Amendment to Executive Employment Agreement, dated March 24, 2021, by and between the Registrant and Catherine Vaczy, incorporated by reference to Exhibit 10.1 of the Registrant’s Current Report on Form 8-K filed on March 25, 2021.

10.26	+	First Amendment to Executive Employment Agreement, dated March 24, 2021, by and between the Registrant and Michael Redman, incorporated by reference to Exhibit 10.2 of the Registrant’s Current Report on Form 8-K filed on March 25, 2021.

10.27	+	Offer Letter, dated September 27, 2021, by and between the Registrant and Mark S. Berger, M.D., incorporated by reference to Exhibit 10.1 of the Registrant’s Form 8-K filed on September 28, 2021.

10.28	+	Offer Letter dated September 27, 2021, by and between the Registrant and Hemant Kumar, PhD, incorporated by reference to Exhibit 10.3 of the Registrant’s Current Report on Form 8-K filed on September 28, 2021.

10.29	++	First Amendment to Exclusive License Agreement, dated August 17, 2022, by and between Genprex, Inc. and the University of Pittsburgh - Of the Commonwealth System of Higher Education, incorporated by reference to Exhibit 10.1 of the Registrant's Current Report on Form 8-K filed on August 22, 2022.

Exhibit Number		Description of Exhibit
10.30		Equity Distribution Agreement, dated November 18, 2022, by and between Genprex, Inc. and JMP Securities LLC, incorporated by reference to Exhibit 1.1 of the Registrant's Current Report on Form 8-K filed on November 18, 2022.

10.31	++	Exclusive License Agreement, dated November 22, 2022, by and between Genprex, Inc. and the University of Pittsburgh - Of the Commonwealth System of Higher Education, incorporated by reference to Exhibit 10.1 of the Registrant's Current Report on Form 8-K filed on November 28, 2022.

10.32	++	Exclusive License Agreement, dated December 29, 2022, by and between Genprex, Inc. and the University of Pittsburgh - Of the Commonwealth System of Higher Education, incorporated by reference to Exhibit 10.1 of the Registrant's Current Report on Form 8-K filed on January 5, 2023.

10.33		Form of Securities Purchase Agreement, dated March 1, 2023, incorporated by reference to Exhibit 10.1 of the Registrant's Current Report on Form 8-K filed on February 27, 2023.

23.1	*	Consent of Daskzal Bolton LLP, Independent Registered Public Accounting Firm.

31.1	*	Certification of Chief Executive Officer Pursuant to Rules 13a-14(a) of the Securities Exchange Act, 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) of the Securities Exchange Act, as Adopted Pursuant to Section 302 of the Sarbanes-Oxley Act of 2002.

32.1	**	Certification 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 Document.

104	*	Cover Page Interactive Data File (Formatted as Inline XBRL and contained in Exhibit 101)

+	Indicates management contract or compensatory plan.
++	Pursuant to Item 601(b)(10) of Regulation S-K, certain confidential portions of this exhibit were omitted by means of marking such portions with an asterisk because the identified confidential portions (i) are not material and (ii) would be competitively harmful if publicly disclosed.

	GENPREX, INC.


Date: March 31, 2023	By:	/s/ J. Rodney Varner
		J. Rodney Varner
		Chief Executive Officer
		(Principal Executive Officer)

Signature	Title	Date
/s/ J. Rodney Varner	Chief Executive Officer and Chairman of the Board of Directors	March 31, 2023
J. Rodney Varner	(Principal Executive Officer)

/s/ Ryan M. Confer	Chief Financial Officer	March 31, 2023
Ryan M. Confer	(Principal Financial and Accounting Officer)

/s/ Brent Longnecker	Member of the Board of Directors	March 31, 2023
Brent Longnecker

/s/ Jose Antonio Moreno Toscano	Member of the Board of Directors	March 31, 2023
Jose Antonio Moreno Toscano

/s/ Will R. Wilson, Jr.	Member of the Board of Directors	March 31, 2023
Will R. Wilson, Jr.

Report of Independent Registered Public Accounting Firm (PCAOB ID Number 0229)		F-2
Balance Sheets - December 31, 2022 and December 31, 2021		F-3
Statements of Operations - December 31, 2022 and December 31, 2021		F-4
Statements of Changes in Stockholders’ Equity - December 31, 2022 and December 31, 2021		F-5
Statements of Cash Flows - December 31, 2022 and December 31, 2021		F-6
Notes to Financial Statements		F-7

		*Year Ended*
		*December 31,*
	*2022*			*2021 (Revised)*
Assets
Current assets:
Cash	$	20,954,069		$	38,628,876
Accounts receivable		34,852			—
Prepaid expenses and other		484,224			511,348
Total current assets		21,473,145			39,140,224
Property and equipment, net		23,032			48,608
Other assets:
Security deposits		21,818			8,691
Supplies		2,864,937			3,022,403
Intellectual property, net		702,095			642,360
Total other assets		3,588,850			3,673,454
Total assets	$	25,085,027		$	42,862,286
Liabilities and Stockholders' Equity
Current liabilities:
Accounts payable	$	442,925		$	973,195
Other current liabilities		2,367,362			612,100
Total current liabilities		2,810,287			1,585,295
Stockholders' equity:
Common stock $0.001 par value: 200,000,000 shares authorized; 48,105,962 and 47,874,708 shares issued and outstanding, respectively		48,106			47,874
Additional paid-in capital		125,054,453			120,316,315
Accumulated deficit		(102,827,819	)		(79,087,198	)
Total stockholders' equity		22,274,740			41,276,991
Total liabilities and stockholders' equity	$	25,085,027		$	42,862,286

	*Common Stock*
	*Shares*		*Amount*		*Additional Paid-In Capital*		*Accumulated Deficit*			*Total*
Balance at December 31, 2020		43,117,681	$	43,118	$	89,295,601	$	(58,422,229	)	$	30,916,490
Issuance of stock for cash		4,670,889		4,670		25,673,241		—			25,677,911
Issuance of stock for services		86,138		86		155,959		—			156,045
Share based compensation		—		—		5,191,514		—			5,191,514
Net loss		—		—		—		(20,664,969	)		(20,664,969	)
Balance at December 31, 2021		47,874,708	$	47,874	$	120,316,315	$	(79,087,198	)	$	41,276,991
Issuance of stock for cash		120,859		121		6,305		—			6,426
Issuance of stock for services		110,395		111		163,121		—			163,232
Share based compensation		—		—		4,568,712		—			4,568,712
Net loss		—		—		—		(23,740,621	)		(23,740,621	)
Balance at December 31, 2022		48,105,962	$	48,106	$	125,054,453	$	(102,827,819	)	$	22,274,740

	December 31, 2021
Balance Sheet	As Previously Reported	Adjusted	As Revised

Total assets	42,862,286	-	42,862,286

Total liabilities	1,585,295	-	1,585,295

Common stock	47,874	-	47,874
Additional paid-in capital	119,246,970	1,069,345	120,316,315
Accumulated deficit	(78,017,853)	(1,069,345)	(79,087,198)
Total stockholders' equity	41,276,991	-	41,276,991

	For the Year ended December 31, 2021
Statement of Operations	As Previously Reported	Adjusted	As Revised

Revenues	-	-	-

Depreciation	22,534		22,534
Research and development	8,607,751	363,114	8,970,865
General and administrative	10,970,472	706,231	11,676,703
Total costs and expenses	19,600,757	1,069,345	20,670,102
Operating loss	(19,600,757)	(1,069,345)	(20,670,102)
Interest income	5,133	-	5,133
Net Loss	(19,595,624)	(1,069,345)	(20,664,969)
Loss per share	(0.42)	(0.02)	(0.44)
Weighted average common shares outstanding	47,097,251		47,097,251

	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.