Genprex Inc

GENPREX, INC.

MARCH 31, 2024

Note1 - Description of Business and Basis of Presentation

Unless the context requires otherwise, references to “Genprex,” the “Company,” “we,” “us” or “our” in this Quarterly Report on Form10-Q refer to Genprex, Inc. Genprex, incorporated in Delaware in* April 2008,is a clinical stage gene therapy company pioneering the development of gene-based therapies for large patient populations with unmet medical needs. The Company’s oncology platform utilizes its systemic, non-viral Oncoprex® Delivery System which uses lipid-based nanoparticles in a lipoplex form to deliver tumor suppressor gene-expressing plasmids to cancer cells. The product is administered intravenously, where it is taken up by tumor cells that then express tumor suppressor proteins that were deficient in the tumor. The Company’s diabetes technology is designed to work in Type1* diabetes by transforming alpha cells in the pancreas into functional beta-like cells, which can produce insulin but* maybe distinct enough from beta cells to evade the body’s immune system. In Type2* diabetes, the Company’s technology is believed to work by replenishing and rejuvenating exhausted beta cells that make insulin.

Oncology Platform

Genprex’s lead oncology drug candidate, Reqorsa® (quaratusugene ozeplasmid) Immunogene Therapy, previously referred to as GPX-001, is initially being developed in combination with prominent, approved cancer drugs to treat Non-Small Cell Lung Cancer (“NSCLC”) and Small Cell Lung Cancer (“SCLC”). REQORSA has a multimodal mechanism of action whereby it interrupts cell signaling pathways that cause replication and proliferation of cancer cells, re-establishes pathways for apoptosis, or programmed cell death, in cancer cells, and modulates the immune response against cancer cells. In early studies, REQORSA has been shown to be complementary with targeted drugs and immunotherapies. The Company’s strategy is to develop REQORSA in combination with current approved therapies and the Company believes REQORSA’s unique attributes position it to provide treatments that improve on these current therapies for patients with NSCLC, SCLC, and possibly other cancers.

Acclaim-1: The Company is currently enrolling and treating patients in the Phase2a expansion portion of its Phase1/2 Acclaim-1 clinical trial. The Acclaim-1 trial uses a combination of REQORSA and AstraZeneca’s Tagrisso® (osimertinib) in patients with late-stage NSCLC that has activating epidermal growth factor receptor (“EGFR”) mutations and progression after treatment with Tagrisso. Following the* May 2023completion of the Phase1* dose escalation portion of the study, the Acclaim-1 Safety Review Committee (“Acclaim-1 SRC”) approved advancement from the Phase1 dose escalation portion to the Phase2a expansion portion of the study. Based on a review of safety data which showedno dose limiting toxicities (“DLTs”), the Acclaim-1 SRC determined the recommended Phase2 dose (“RP2D”) of REQORSA to be0.12 mg/kg. This was the highest dose level delivered in the Phase1 portion of the study and is twice the highest dose level delivered in the Company’s prior clinical trial combining REQORSA with Tarceva® (erlotinib) for the treatment of late-stage lung cancer. Genprex opened the Phase2a expansion portion of the study and enrolled and dosed thefirst patient in* January 2024.The Phase2a* expansion portion of the trial is expected to enroll approximately66 patients; half will be patients who received only prior Tagrisso treatment and the other half will be patients who received prior Tagrisso treatment and chemotherapy. The aim is to determine toxicity and efficacy profiles of patients with different eligibility criteria. There will be an interim analysis following the treatment of19 patients in each cohort. The Company expects to complete the enrollment of19 patients in each cohort of the Phase2a expansion portion of the study by the end of2024, and thus the Company expects the interim analyses in early2025. The United States Food and Drug Administration (“FDA”) has granted Fast Track Designation for the Acclaim-1 treatment combination of REQORSA and Tagrisso in NSCLC patients who have progressed after Tagrisso treatment.

Acclaim-2: The Company is currently enrolling and treating patients in the Phase1 dose escalation portion of its Phase1/2 Acclaim-2 clinical trial. The Acclaim-2 trial uses a combination of REQORSA and Merck & Co.’s Keytruda® (pembrolizumab) in patients with late-stage NSCLC whose disease has progressed after treatment with Keytruda. Patients are currently being treated at the0.06 mg/kg dose level in thefirst cohort of patients and, subject to Acclaim-2 Safety Review Committee (“Acclaim-2 SRC”) approval, will be treated at successive dose levels of0.09 mg/kg and0.12 mg/kg. The Company expects enrollment in the dose escalation portion of the study to be completed in thesecond half of2024. The Company will then initiate and evaluate patients in the Phase2a expansion portion of the study at the maximum tolerated dose (the “MTD”) orRP2D. The FDA has granted Fast Track Designation for the Acclaim-2 treatment combination of REQORSA and Keytruda in NSCLC patients who have progressed after Keytruda treatment.

The expansion portion of both the Acclaim-1 and Acclaim-2 trials are Phase2 studies. The expansion portion of these studies provides the Company with the advantage of early insight into drug effectiveness in defined and distinct patient populations at the MTD orRP2D in order to better evaluate efficacy and increase the likelihood of a successful randomized Phase2 trial which will follow the expansion portion of each study.

Acclaim-3: The Company is currently enrolling and treating patients in the Phase1 dose escalation portion of its Phase1/2 Acclaim-3 clinical trial. The Acclaim-3 clinical trial uses a combination of REQORSA and Genentech, Inc.’s Tecentriq® (atezolizumab) as maintenance therapy in patients with extensive stage small cell lung cancer (“ES-SCLC”) who didnot develop tumor progression after receiving Tecentriq and chemotherapy as initial standard treatment. Patients are treated with REQORSA and Tecentriq until disease progression or unacceptable toxicity is experienced. In* January 2024,the Company opened the Phase1* portion of the Acclaim-3 study for enrollment and enrolled and dosed thefirst patient in* May**2024.* The Company expects to complete the Phase1 dose escalation portion of the study during thesecond half of2024 and the Company expects to start the Phase2 expansion portion of its Acclaim-3 study in thesecond half of2024. In* June 2023,the FDA granted Fast Track Designation for the Acclaim-3 treatment combination of REQORSA and Tecentriq as maintenance therapy in patients with ES-SCLC who didnot* develop tumor progression after receiving Tecentriq and chemotherapy as initial standard treatment. In* August 2023,*the FDA granted Orphan Drug Designation to REQORSA for the treatment of SCLC.

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TheTUSC2 gene, which is the key component of REQORSA and plays a vital role in cancer suppression and normal cell regulation, isone of a series of genes on the short arm of Chromosome3 whose therapeutic use is covered by the Company’s exclusive worldwide licenses from The University of Texas MD Anderson Cancer Center (“MD Anderson”). Genprex believes that its ONCOPREX Delivery System allows for delivery of a number of cancer-fighting genes, alone or in combination with other cancer therapies, to combat multiple types of cancer and the Company is in early stages of discovery programs to identify other cancer candidates. In* August 2022,Genprex entered into athree*-year sponsored research agreement with MD Anderson to support further preclinical studies ofTUSC2 and other tumor suppressor genes.

Diabetes Gene Therapy

In diabetes, the Company has exclusively licensed from the University of Pittsburgh of the Commonwealth System of Higher Education (“University of Pittsburgh”) multiple technologies relating to the development of a gene therapy product for each of Type1 and Type2 diabetes. The same general novel approach is used in each of Type1 and Type2 diabetes whereby an adeno-associated virus (“AAV”) vector containing thePdx1 and MafA genes is administered directly into the pancreatic duct. In humans, this can be done with a routine endoscopy procedure. The Company’s diabetes product candidates are currently being evaluated and optimized in preclinical studies at the University of Pittsburgh. GPX-002 is being developed using the same construct for the treatment of both Type1 diabetes and Type2 diabetes. GPX-002 for Type1 diabetes is designed to work by transforming alpha cells in the pancreas into functional beta-like cells, which can produce insulin but* maybe distinct enough from beta cells to evade the body’s immune system. In a similar approach, GPX-002 for Type2* diabetes (formerly known as GPX-003), where autoimmunity isnot at play, is believed to work by replenishing and rejuvenating exhausted beta cells that make insulin. Genprex finalized the components of the diabetes construct to take forward for nonclinical studies and in* December 2023,the Company submitted a request to meet with the FDA to obtain their guidance on the nonclinical studies needed to file an Investigational New Drug (“IND”) application and initiatefirst*-in-human studies. As a result of the FDA’s response, the Company will continue with its planned additional nonclinical studies before requesting regulatory guidance in2024 for the IND-enabling studies. In* October 2023,Genprex entered into aone*-year extension to its* August 2022sponsored research agreement with the University of Pittsburgh for the use of GPX-002 in a non-human primate (“NHP”) model in Type2* diabetes. The extension includes a revised research plan to encompass the Company’s most recent technologies to which it acquired exclusive rights from the University of Pittsburgh in* July 2023.These include a MafB promoter to drive expression of thePdx1* and MafA transcription factors that can potentially be used for both Type1 and Type2 diabetes. See also “Note7 – Commitments and Contingencies” to the Company’s unaudited condensed financial statements included in this Quarterly Report on Form10-Q.

Capital Requirements, Liquidity and Going Concern Considerations

The Company's unaudited condensed financial statements are prepared in accordance with accounting principles generally accepted in the United States of America (“US GAAP”) applicable to a going concern, which contemplates the realization of assets and liquidation of liabilities in the normal course of business. However, the Company has sustained substantial losses from operations since inception and hasno current source of revenue. In addition, the Company has used, rather than provided, cash in its operations. Genprex expects to continue to incur significant expenditures to further clinical trials for the commercial development of its patents.

The Company recognizes that it must obtain additional capital resources to successfully commercialize its product candidates. To date, Genprex has received funding in the form of equity and debt, and the Company plans to seek additional funding in the future. However,no assurances can be given that it will be successful in raising additional capital. If the Company isnot able to timely and successfully raise additional capital, the timing of its clinical trials, financial condition and results of operations* maybe materially and adversely affected. These unaudited condensed financial statements donot* include any adjustments relating to the recoverability and classification of recorded asset amounts and classification of liabilities.

Genprex believes that its current cash and cash equivalents will be sufficient to fund expenditure requirements for its necessary operations and expected clinical trial activities into thethird quarter of2024. The Company has based these estimates, however, on assumptions that* mayprove to be wrong, and could spend available financial resources much faster than it currently expects. The Company will need to raise additional funds to continue funding its development and operations. The Company plans to secure such additional funding, although there areno* guarantees or commitments for additional funding.

As a result of its recurring losses from operations and the need for additional financing to fund its operating and capital requirements, there is uncertainty regarding the Company’s ability to maintain liquidity sufficient to operate its business effectively, which raises substantial doubt as to the Company’s ability to continue as a going concern. The unaudited condensed financial statements donot include any adjustments that might be necessary if the Company is unable to continue as a going concern.

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Note2 - Summary of Significant Accounting Policies

Genprex’s unaudited condensed financial statements have been prepared in accordance with US GAAP and the requirements of the United States Securities and Exchange Commission (the “SEC”) for interim reporting. As permitted under those rules, certain footnotes or other financial information that is normally required by US GAAP can be condensed or omitted. Accordingly, they donot include all of the information and footnotes normally included in financial statements prepared in conformity with US GAAP. The* December 31, 2023condensed balance sheet was derived from the December 31, 2023audited financial statements. Genprex’s unaudited condensed financial statements should be read in conjunction with the financial statements and notes thereto included in the Company’s2023* Annual Report on Form10-K, filed with the SEC on* April 1, 2024 (the “Form10*-K”).

The accompanying condensed financial statements are unaudited and include all adjustments (consisting of normal recurring adjustments) that management considers necessary for a fair presentation of Genprex’s condensed financial position and results of operations for the interim periods presented. The results of operations for the interim periods arenot necessarily indicative of the results that* may*be expected for any other interim period or for the entire year.

A summary of Genprex’s significant accounting policies consistently applied in the preparation of the accompanying unaudited condensed financial statements follows.

Reverse Stock Split

On* February 2, 2024,Genprex completed a1*-for-40 reverse stock split (“Reverse Split”) of its issued and outstanding shares of common stock. The Reverse Split didnot change the number of authorized shares of common stock or par value. All references in these unaudited condensed financial statements to shares, share prices, exercise prices, and other per share information in all periods have been adjusted, on a retroactive basis, to reflect the Reverse Split (see Note4 – Equity – Reverse Stock Split).

Use of Estimates

The preparation of Genprex’s unaudited condensed financial statements in conformity with US GAAP requires the Company 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

Genprex considers all highly liquid short-term investments with an initial maturity ofthree months or less to be cash equivalents. Any amounts of cash in financial institutions which exceed Federal Deposit Insurance Corporation (“FDIC”) insured limits expose the Company to cash concentration risk. The Company has cash in a money market account and had $7,967,044 and $6,490,117 in excess of FDIC insured limits of*$250,000* at* March 31, 2024* and* December 31, 2023*, respectively. Any loss incurred or a lack of access to such funds could have a significant adverse impact on the Company’s financial condition, results of operations, and cash flows.

Net Loss Per Share

Basic net loss per share is calculated by dividing the net loss by the weighted-average number of shares of common stock outstanding for the period, without consideration for potential dilutive shares of common stock, which includes common stock equivalents consisting of (i)3,643,636 unexercised options granted by the Company’s board of directors and unexercised warrants to purchase shares of common stock, and (ii)33,361 unvested restricted stock units granted by the Company’s board of directors representing the right upon vesting to receive shares of common stock as of* March 31, 2024*.

Fair Value of Financial Instruments

The carrying amounts reported in the condensed balance sheets for cash, money-market savings account, accounts receivable, and accounts payable approximate fair value because of the immediate or short-term maturity of these condensed financial instruments.

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Property and Equipment

Property and equipment are stated at cost less accumulated depreciation. Depreciation is calculated using the straight-line method over the estimated useful lives of the assets, which range from three tofive 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 strategies for current and future programs associated with the Company’s preclinical and Phase1/2 clinical trials. These expenditures are expensed in the period incurred and include payments to collaborative research partners, manufacturing partners and consultants, and clinical strategy partners, wages and associated employee benefits, facilities, and overhead costs.

Materials acquired to be used in clinical research, that have an alternative future use, are capitalized when the materials are acquired, and included in research and development supplies. These supplies are recognized as expense as they are consumed through use for testing or clinical activities, or have spoiled. The costs of materials that were acquired for a particular research and development activity and haveno alternative future use are expensed in the period acquired.

Research and development supplies purchased, valued at cost, and capitalized for future use were $2,532,226 and $2,347,488 at* March 31, 2024* and* December 31, 2023*, respectively.

Intellectual Property

Intellectual property consists of legal and related costs associated with patents, trademarks, and other proprietary technology and rights developed, acquired, or licensed by Genprex that it believes contribute to a probable economic benefit toward such patents and activities. Costs incurred in connection with obtaining intellectual property protection, such as patent applications and filing fees associated with patent protection, are capitalized. Intellectual property is stated at cost and is to be amortized on a straight-line basis over the estimated useful lives of the assets.

Accounting for Stock-Based Compensation

Genprex uses the fair value-based method of accounting for stock-based compensation for options granted to employees, independent consultants and contractors. The Company measures options granted at fair value determined as of the grant date and recognizes the expense over the periods in which the options vest or are expected to vest and 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

Genprex reviews 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, the Company performs an analysis of the anticipated undiscounted future net cash flow of the individual assets over the remaining amortization period. The Company recognizes an impairment loss if the carrying value of the asset exceeds the discounted expected future cash flows. During thethree months ended* March 31, 2024* and2023, there wereno deemed impairments of the Company’s long-lived assets.

Recent Accounting Developments

Accounting pronouncements issued butnot effective until after* March 31, 2024*, arenot expected to have a significant effect on the Company’s financial condition, results of operations, or cash flows.

In* November 2023,the Financial Accounting Standards Board (“FASB”) issued Accounting Standards Update (“ASU”)2023-07, “Segment Reporting (Topic280*): Improvements to Reportable Segment Disclosures,” which is intended to improve reportable segment disclosure requirements, primarily through enhanced disclosures about significant segment expenses. The purpose of the amendment is to enable investors to better understand an entity’s overall performance and assess potential future cash flows. The guidance is effective for fiscal years beginning after* December 15, 2023,and interim periods within fiscal years beginning after December 15, 2024,with early adoption permitted. The Company is currently evaluating the effect the amendments in ASU2023*-07 will have on its segment disclosures.

In* December 2023,the FASB issued ASU2023*-09, “Income Taxes (Topic740): Improvements to Income Tax Disclosures,” which modifies the rules on income tax disclosures to require disaggregated information about a reporting entity’s effective tax rate reconciliation as well as information on income taxes paid. The standard is intended to benefit investors by providing more detailed income tax disclosures that would be useful in making capital allocation decisions. The guidance is effective for annual periods beginning after* December 15, 2024,with early adoption permitted. The Company is currently evaluating the effect the amendments in ASU2023*-09 will have on its tax disclosures.

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Note3 - Intellectual Property

As of* March 31, 2024*, Genprex owned or had exclusive license agreements on 21 granted patents and 24 pending patent applications worldwide for technologies developed in-house or 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.

University of Pittsburgh

On* February 11, 2020,Genprex entered into an exclusive license agreement with the University of Pittsburgh for patented gene therapy technologies relating to the potential treatment of Type1* and Type2 diabetes. This license wasfirst amended on* August 17, 2022,to extend the milestone related to the filing of a new investigational drug (“IND”) application. This license was amended again on November 3, 2022,to include a new licensed glucagon promoter technology related to Type1* diabetes and set FDA and clinical milestones related to the glucagon technology (see Note7 – Commitments and Contingences – Commitments – University of Pittsburgh).

On* November 22, 2022,Genprex entered into an exclusive license agreement with the University of Pittsburgh relating to the transformation of macrophages enabling them to reduce autoimmunity activity in Type1* diabetes.

On* December 29, 2022,Genprex entered into an exclusive license agreement with the University of Pittsburgh relating to the use of an insulin promoter in combination with the Company’s existing gene therapy, including thePdx1* and MafA transcription factors, as a potential treatment for Type2 diabetes.

On* July 14, 2023,Genprex entered into an exclusive license agreement with the University of Pittsburgh related to a gene therapy for both Type1* and Type2 diabetes using a MafB promoter to drive expression of thePdx1 and MafA transcription factors.

The University of Texas MD Anderson Cancer Center

On* May 4, 2020,*Genprex 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 patent applications and related technology for the treatment of cancer using the Company’s lead drug candidate and immunotherapies.

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Note4 - Equity

Reverse Stock Split

At Genprex’s special meeting of stockholders held on* December 14, 2023,the Company’s stockholders granted the Company’s board of directors the discretion to effect a reverse stock split of the Company’s issued and outstanding common stock through an amendment (the “Certificate of Amendment”) to the Company’s Amended and Restated Certificate of Incorporation, as amended and restated to date, at a ratio ofnot* less than1-for-10 andnot more than1-for-50, such ratio to be determined by the Company’s board of directors. On* January 19, 2024,the Company’s board of directors approved a1*-for-40 reverse stock split and authorized the filing of the Certificate of Amendment for the Reverse Split with the Secretary of State of the State of Delaware. The Reverse Split became effective in accordance with the terms of the Certificate of Amendment on* February 2, 2024.The Certificate of Amendment didnot* change the number of authorized shares of common stock or the par value. All references in these unaudited condensed financial statements to shares, share prices, exercise prices, and other per share information in all periods have been adjusted, on a retroactive basis, to reflect the Reverse Split.

Registered Direct Offerings

On* March 1, 2023,Genprex completed a registered direct offering, in which the Company sold to an accredited healthcare-focused institutional investor an aggregate of 95,239 shares of its common stock and warrants to purchase up to 95,239 shares of its common stock, at a combined offering price of $42.00 per share of common stock and accompanying warrant. The warrants are exercisable immediately upon issuance, expire 5 years from the date of issuance and have an exercise price of $44.00 per share. The Company received net proceeds of approximately $3.6 million after $400,000 of commissions and expenses, excluding any proceeds that may*be received in the future from any exercise of the warrants.

On* July 21, 2023,Genprex completed a registered direct offering priced at the market under Nasdaq rules, in which the Company sold to accredited healthcare-focused institutional investors an aggregate of (i)185,644 shares of its common stock, and (ii) warrants to purchase up to 185,644 shares of its common stock, at a combined offering price of $40.40 per share of common stock and accompanying warrant. The warrants are exercisable immediately upon issuance, expire 5 years from the date of issuance and have an exercise price of $35.40 per share. Also, the Company agreed to issue to H.C. Wainwright & Co., LLC or its designees (the “Placement Agent”) warrants to purchase up to an aggregate of 11,140 shares of the Company’s common stock. The warrants issued to the Placement Agent have substantially the same terms as the warrants issued to the investors except that the Placement Agent warrants have an exercise price of $50.50 per share and expire on July 18, 2028.Genprex received net proceeds of approximately $6.7 million after approximately $800,000 of commissions and expenses, excluding any proceeds that may*be received in the future from any exercise of the warrants.

On* March 21, 2024,the Company completed a registered direct offering priced at the market under Nasdaq rules, in which the Company sold to an institutional investor an aggregate of (i)165,000 shares of common stock, (ii) pre-funded warrants (the “March 2024Pre-Funded Warrants”) exercisable for up to an aggregate of 1,377,112 shares of common stock, and (iii) warrants (the “March 2024Common Warrants”) exercisable for up to an aggregate of 1,542,112 shares of common stock. The offering price for each share of common stock and accompanying March 2024Common Warrant was $4.215, and the offering price for each March 2024Pre-Funded Warrant and accompanying March 2024Common Warrant was $4.2149. The March 2024Pre-Funded Warrants are exercisable immediately upon issuance at an exercise price of $0.0001 per share and will expire when exercised in full. The March 2024Common Warrants are exercisable immediately upon issuance at an exercise price of $4.09 per share and will expire infive years from the date of issuance. The Company received net proceeds of approximately $5.8 million after commissions and expenses, excluding any proceeds that maybe received in the future from any exercise of the March 2024Common Warrants. In connection with the offering, the Company also amended certain existing warrants to purchase up to an aggregate of 194,248 shares of common stock that were previously issued to investors in March 2023and July 2023,with exercise prices of $44.00 and $35.40 per share and expiration dates of March 1, 2028and July 21, 2028*for $0.125 per amended warrant, such that the amended warrants have a reduced exercise price of $4.09 per share and an expiration date offive years from the closing of this offering.

At-The-Market Offering

On* December 13, 2023,Genprex entered into an At The Market (“ATM”) Offering Agreement (the “Agreement”) with H.C. Wainwright & Co., LLC, serving as agent (the “Agent”) with respect to an at-the-market offering program (the“2023* ATM Facility”) under which the Company* mayoffer and sell through the Agent, from time to time at its sole discretion, up to such number or dollar amount of shares of its common stock (the “Shares”) as registered on the prospectus supplement covering the ATM offering, as maybe amended or supplemented from time to time. Any Shares offered and sold pursuant to this Agreement will be issued pursuant to the Company’s currently effective shelf Registration Statement on Form S-3 (FileNo.* 333-271386) filed with the SEC on* April 21, 2023,which was declared effective on June 9, 2023.The Company has agreed to pay the Agent a commission equal tothree* percent (3%) of the gross sales proceeds of any Shares sold through the Agent under the Agreement, and also have provided the Agent with customary indemnification and contribution rights. From* January 1, 2024through the date of filing of this Quarterly Report on Form10*-Q, Genprex has sold 158,474 shares of its common stock for aggregate net proceeds to the Company totaling $881,946 under the2023 ATM Facility.

On* November 18, 2022,Genprex entered into an Equity Distribution Agreement with JMP Securities LLC (“JMP Securities”) pursuant to which the Company could sell from time to time, at its option, shares of its common stock through JMP Securities, as sales agent (the“2022* ATM Facility”), up to an aggregate offering price of $50 million. Sales of the shares were made under the Company’s previously filed Registration Statement on Form S-3 (Reg.No. 333-239134), by means of ordinary brokers’ transactions on the NASDAQ Global Market or otherwise. Additionally, under the terms of the Sales Agreement, the shares could be sold at market prices, at negotiated prices or at prices related to the prevailing market price. Genprex agreed to pay JMP Securities a commission of 3.0% of the gross proceeds from the sale of the shares. During thethree months ended* March 31, 2023*, the Company sold 1,342 shares of common stock for aggregate net proceeds of $78,355 under the2022 ATM Facility. On* December 12, 2023,the Company provided notice to JMP Securities of its termination of the2022* ATM Facility. The termination of the Equity Distribution Agreement with JMP Securities was effective as of* December 13, 2023.*

Stock Issuances

During thethree months ended* March 31, 2024*, Genprex issued (i)125 shares of common stock for services provided to the Company valued at $1,170 to the Chairman of its Scientific Advisory Board, (ii)36,250 shares of common stock to service providers of the Company valued at $179,550, (iii)12,145 shares of common stock upon the vesting of restricted stock units (“RSUs”) valued at $53,438 to Company executives and employees, (iv)64,690 shares of common stock due to adjustments related to the Company's Reverse Split, (v)158,474 shares of common stock sold for aggregate net proceeds of $881,946 under the Company's2023 ATM Facility, as described above, and (vi)165,000 shares of common stock sold for aggregate net proceeds of approximately $5.8 million associated with the Company's* March 2024*offering, as described above.

During thethree months ended* March 31, 2023*, Genprex issued (i)125 shares of common stock for services provided to the Company valued at $7,950 to the Chairman of its Scientific Advisory Board, (ii)1,342 shares of common stock for aggregate net proceeds of $78,355 under the Company's2022 ATM Facility, as described above, and (iii)95,239 shares of its common stock sold for aggregate net proceeds of approximately $3.6 million associated with the Company's* March 2023*offering, as described above.

Preferred Stock

Genprex is authorized to issue 10,000,000 shares of preferred stock with a par value of $0.001 per share, none of which are outstanding as of* March 31, 2024* and* December 31, 2023*.

Common Stock

Genprex is 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 1,922,586 and 1,485,902 shares of its common stock outstanding as of* March 31, 2024* and* December 31, 2023*, respectively.

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Common Stock Purchase Warrants

Common stock purchase warrant activity for thethree months ended* March 31, 2024* and2023, respectively, is as follows:

During thethree months ended* March 31, 2024*, and in connection with the registered direct offering, with an institutional investor, completed on* March**21,* 2024, Genprex (i) issued pre-funded warrants to purchase up to an aggregate of 1,377,112 shares of common stock at a nominal exercise price of $0.0001 per share, the remaining balance of the purchase price of each share of common stock associated with each pre-funded warrant net of the portion of the subscription price therefor paid at closing, (ii) issued warrants to purchase up to 1,542,112 shares of common stock, at an exercise price of $4.09 per share, (iii) issued warrants to purchase up to 92,527 shares of common stock to H.C. Wainwright & Co., LLC or its designees (“Placement Agent”), at an exercise price of $5.2688 per share, and (iv) amended existing warrants to purchase up to an aggregate of 194,248 shares of common stock that were previously issued to the same institutional investor in* March 2023and July 2023,such that the amended warrants have a reduced exercise price of $4.09 per share and an expiration date offive years from the closing of the March 2024offering. During thethree* months ended* March 31, 2024*, Genprex recorded share-based compensation of $8,917, associated with the vesting and issuance of warrants. The Company expects to record an additional $9,122 of share-based compensation for time-based vesting through the end of the fiscal year2024 and $300,000 of share-based compensation based on performance-based vesting in the future with respect to its warrants outstanding as of* March 31, 2024*.

During thethree months ended* March 31, 2023,Genprex (i) issued a warrant to purchase up to 750 shares of common stock to a service provider at an exercise price of $66.00 per share, the fair market value of a share of common stock on the date of issuance, (ii) issued a warrant to purchase up to 95,239 shares of common stock to the accredited healthcare-focused institutional investor in connection with the registered direct offering at an exercise price of $44.00 per share, and (iii) was deemed to cancel warrants to purchase 960 shares of common stock upon termination of warrants previously issued to placement agents associated with the Company’s Initial Public Offering in March 2018.During thethree*-month period ended* March 31, 2023,*the Company recorded share-based compensation of $43,300 associated with the vesting and issuance of warrants.

As of* March 31, 2024*, Genprex had outstanding warrants to purchase 3,358,191 shares of common stock at a weighted average exercise price of $5.93 that have been issued to various consultants, investors, and placement agents. These warrants vest immediately or over periods ranging up to12 months, are exercisable for a period of up tofive years, enable the holders to purchase shares of the Company’s common stock at exercise prices ranging from $4.09 to $288.80 per share and have per-share fair values ranging from $1.21 to $185.00, based on Black-Scholes-Merton pricing models. The following assumptions were used in calculation of fair market value of options via Black-Scholes-Merton pricing models for thethree months ended* March 31, 2024* and2023:

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2018 Equity Incentive Plan

The Company’s board of directors and stockholders have approved and adopted the Genprex2018 Equity Incentive Plan (“2018 Plan”), which became effective on the completion of the Company’s IPO on* April 3, 2018.The2018* Plan provides for the grant of incentive stock options that are intended to qualify under Section422 of the Internal Revenue Code of1986, as amended (“ISOs”), nonstatutory stock options, stock appreciation rights, restricted stock awards, RSU awards, performance-based stock awards and performance-based cash awards. ISOs* maybe 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 104,000 shares of common stock were initially available under the2018 Plan, plus a number of shares of common stock (not to exceed 65,719 shares) subject to outstanding awards under the Company’s2009 Equity Incentive Plan (the*“2009* Plan”) as of the IPO that expire, are forfeited or otherwise terminate or that are used to cover the exercise price or applicable tax withholdings.No further grants will be made under the2009 Plan.

In addition, the number of shares of common stock reserved for issuance under the2018 Plan automatically increases on* January 1of each year, since January 1, 2019,by 5% of the total number of shares of the Company’s common stock outstanding on December 31of the preceding calendar year, or a lesser number of shares determined by the Company’s board of directors or a committee of the board of directors appointed to administer the2018* Plan.

On* January 1, 2023and2024,* the number of shares of common stock reserved for issuance under the2018 Plan was increased by an aggregate of 60,132 and 74,294 shares, respectively. As of* March 31, 2024*, a total of 86,418 shares of common stock remain available for issuance under the2018 Plan.

2018 Employee Stock Purchase Plan

The Company’s board of directors and stockholders approved and adopted the Genprex2018 Employee Stock Purchase Plan (“ESPP”), which became effective on* April 3, 2018.The ESPP hasnot* yet been utilized as a benefit available to the Company’s employees. The ESPP authorizes the issuance of 5,202 shares of common stock pursuant to purchase rights that* maybe granted to eligible employees. The number of shares of common stock reserved for issuance under the ESPP is automatically increased on January 1of each calendar year, beginning on January 1, 2019,by 2% of the total number of shares of common stock outstanding on December 31of the preceding calendar year, or a lesser number of shares determined by the administrator of the ESPP. The administrator of the ESPP determinednot* to increase the number ofshares reserved for issuance under the ESPP on* January 1, 2024*.

Stock Options

As of* March 31, 2024*, Genprex had outstanding stock options to purchase 285,445 shares of common stock that have been granted to various executives, employees, directors, and independent contractors of the Company, including outstanding stock options to purchase 25,417 shares of common stock issued as inducement grants, outside of the2018 Plan, associated with the hiring of new executives in2021 and2023. These options vest immediately or over periods ranging from 12 to 48 months, are exercisable for a period of up toten years, and enable the holders to purchase shares of the Company’s common stock at exercise prices ranging from $18.00 to $392.00 per share. The per-share fair values of these options range from $12.62 to $317.20. There wereno options issued for thethree months ended* March 31, 2024*. Assumptions of the Black-Scholes-Merton pricing model for options issued for thethree months ended* March 31, 2024*, and2023, respectively, is as follows:

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During thethree months ended* March 31, 2024*, the Company cancelled stock options to purchase 438 shares of common stock with an exercise price of $32.40 per share in connection with the termination of an employee.

During thethree months ended* March 31, 2023*, the Company granted stock options to purchase an aggregate of 2,063 shares of common stock with exercise prices ranging from $52.00 to $60.40 per share to employees.

The weighted average remaining contractual term for the outstanding options at* March 31, 2024* and* December 31, 2023* is 5.88 and 6.13 years, respectively.

Stock option activity for thethree months ended* March 31, 2024* and2023, respectively, is as follows:

Restricted Stock Units

During thethree months ended* March 31, 2024*, the Company (i) withheld 6,086 RSUs to cover taxes, and (ii) issued 12,145 shares of common stock, associated with the vesting of RSUs. During thethree months ended* March 31, 2023*, the Company issued 47,834 RSUs to executives, employees, and board members.

A summary of the RSU activity under the2018 Plan during thethree months ended* March 31, 2024* and2023, respectively, is presented below. These amounts include RSUs granted to executives, other employees, and board members.

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Share-Based Compensation

For thethree months ended* March 31, 2024*, the Company’s total share-based compensation was approximately $0.5 million, including $0.1 million of R&D expense and $0.4 million of G&A expense, respectively, nearly all of which represents the expected vesting of options or RSUs issued to executives, other employees, board members, and service providers. As of* March 31, 2024*, the Company’s total compensation cost related to non-vested time-based stock option awards and warrants granted to executives, other employees, board members, and service providers andnot yet recognized was approximately $3.0 million. The Company expects to record this stock-based compensation expense over the nextthree years using a graded vesting method. As of* March 31, 2024*, the weighted average term over which these expenses are expected to be recognized is 0.95 years.

For thethree months ended* March 31, 2023*, the Company's total share-based compensation was approximately $1.3 million, including $0.3 million of R&D expense and $1.0 million of G&A expense, nearly all of which represents the expected vesting of options issued to executives, other employees, and service providers, respectively.

As of* March 31, 2024*, there areno performance-based stock option awards outstanding andone performance-based warrant outstanding issued to a service provider. The Company’s total compensation cost related to the non-vested performance-based warrantnot yet recognized was approximately $0.3 million. The entirety of this warrant* may*be recognized and recorded upon the achievement of certain clinical milestones.

Note5 -401(k) Savings Plan

In2022, Genprex established a defined contribution savings plan under Section401(k) of the Internal Revenue Code (“401(k) Plan”) and established an employer matching program for participants in the401(k) Plan. The401(k) Plan covers all employees who meet defined minimum age and service requirements, and allows participants to defer a portion of their annual compensation on a pre-tax basis. The Company incurred $37,390 and $63,048 of expense for matching contributions to the401(k) Plan during thethree months ended* March 31, 2024* and2023, respectively.

Note6 - Related Party Transactions

Introgen Research Institute

Introgen Research Institute (“IRI”) is a Texas-based technology company formed by Rodney Varner, the Company’s former President, Chief Executive Officer and Chairman of the Board, who served in such capacity until his death on* May 7, 2024,and IRI’s sole officer. IRI is owned by trusts of which Mr. Varner's descendants are the sole beneficiaries. In April 2009,prior to Mr. Varner becoming an officer and director of Genprex in August 2012,the Company entered into an Assignment and Collaboration Agreement with IRI, providing Genprex with the exclusive right to commercialize a portfolio of intellectual property. This agreement was amended in2011* to include additional sublicensing of additional intellectual property made available to IRI from MD Anderson (see Note7 – Commitments and Contingences – Commitments – MD Anderson Cancer Center). There wereno amounts incurred or due under this agreement at* March 31, 2024* and* December 31, 2023*.

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Note7 - Commitments and Contingencies

Commitments

MD Anderson Cancer Center

In* July 2018,Genprex entered into atwo*-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. This agreement was extended beyond the original expiration date, expiring in* May 2022after giving effect to such extension. In August 2022,the Company entered into athree*-year sponsored research agreement with MD Anderson to sponsor preclinical studies focused on REQORSA andNPRL2 in oncology to resensitize NSCLC and SCLC to targeted therapies and immunotherapies with a projected total cost of approximately $2.9 million. The Company incurredno expense from this agreement during each of thethree months ended* March 31, 2024* and2023, respectively. As of* March 31, 2024*, the Company has paid approximately $960,000 toward this $2.9 million commitment.

In2011, 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 the1994 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 Genprex a worldwide, exclusive, sublicensable license to an additional portfolio ofsix* patents andone patent application and related technology for methods for treating cancer by administration of aTUSC2 therapy in conjunction with EGFR inhibitors or other anti-cancer therapies in patients predicted to be responsive toTUSC2 therapy. Pursuant to the MD License Amendment, the Company agreed to (i) pay annual maintenance fees ranging from the midfive figures to the lowsix figures, (ii) total milestone payments of $6,150,000, (iii) a onetime fee in the midfive figures and (iv) certain patent related expenses. The Company incurredno expense from this agreement during each of thethree months ended* March 31, 2024* and2023, respectively. As of* March 31, 2024*, the Company has paid approximately $320,000 toward this commitment under this agreement.

National Institutes of Health

Genprex has a royalty obligation to the National Institutes of Health (“NIH”) to be paid upon the Company’s receipt of FDA approval using NIH technology. The $240,000 contingent obligation, which increases annually by $20,000, and is $380,000 and $360,000 as of* March 31, 2024* and* December 31, 2023,*respectively, and will be recognized if and when the Company obtains regulatory approval (the event that triggers the payment obligation).

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University of Pittsburgh

Pursuant to an exclusive license agreement dated* February 11, 2020,by and between Genprex and the University of Pittsburgh, amended on August 17, 2022,and amended again on November 3, 2022,the Company agreed to pay (i) an initial licensing fee of $25,000, (ii) annual maintenance fees of $25,000 for thefirst* three years and $40,000 for each subsequent year following thefirst anniversary of the agreement, (iii) royalties ranging from 1.5% to 3% of net sales of licensed technologies, (iv) an annual minimum royalty payment of $250,000 per year beginning in the year of thefirst 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 related to the usage of a glucagon promoter and gene therapy technologies to potentially treat Type1 diabetes. Unless earlier terminated pursuant to its terms, the agreement expires upon the later of (i)20 years after thefirst commercial sale of the licensed technology thereunder and (ii) expiration of the last valid claim under the patent rights. The Company incurred $25,000 of expense from this agreement during each of thethree months ended* March 31, 2024* and2023, respectively. As of* March 31, 2024*, the Company has incurred and paid approximately $150,000 toward this commitment.

Pursuant to an exclusive license agreement dated* November 22, 2022,by and between Genprex 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 thefirst* three years and $40,000 for each subsequent year following thefirst anniversary of the agreement, (iii) royalties ranging from 1.5% to 3% of net sales of licensed technologies, (iv) an annual minimum royalty payment of $250,000 per year beginning in the year of thefirst 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 related to the usage of a macrophage technology and gene therapy technologies to potentially treat Type1 diabetes. Unless earlier terminated pursuant to its terms, the agreement expires upon the later of (i)20 years after thefirst commercial sale of the licensed technology thereunder and (ii) expiration of the last valid claim under the patent rights. The Company incurredno expense from this agreement during each of thethree months ended* March 31, 2024* and2023, respectively. As of* March 31, 2024*, the Company has incurred and paid approximately $50,000 toward this commitment.

Pursuant to an exclusive license agreement dated* December 29, 2022,by and between Genprex 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 thefirst* three years and $40,000 for each subsequent year following thefirst anniversary of the agreement, (iii) royalties ranging from 1.5% to 3% of net sales of licensed technologies, (iv) an annual minimum royalty payment of $250,000 per year beginning in the year of thefirst 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 related to the usage of an insulin promoter and gene therapy technologies to potentially treat Type2 diabetes. Unless earlier terminated pursuant to its terms, the agreement expires upon the later of (i)20 years after thefirst commercial sale of the licensed technology thereunder and (ii) expiration of the last valid claim under the patent rights. The Company incurredno expense from this agreement during each of thethree months ended* March 31, 2024* and2023, respectively. As of* March 31, 2024*, the Company has incurred and paid approximately $25,000 toward this commitment.

Pursuant to an exclusive license agreement dated* July 14, 2023,by and between Genprex 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 thefirst* year, $50,000 for thesecond andthird years, and $100,000 for thefourth year and each subsequent year following thefourth anniversary of the agreement thereafter until the anniversary prior to the year of thefirst commercial sale, (iii) royalties ranging from 1.5% to 3% of net sales of licensed technologies, (iv) an annual minimum royalty payment of $250,000 per year beginning in the year of thefirst commercial sale of licensed technology, (v) a share of non-royalty sublicense income of 20%, and (vi) an aggregate of $4,225,000 in milestone payments related to the usage of an MafB promoter and gene therapy technologies to potentially treat Type1 and Type2 diabetes. Unless earlier terminated pursuant to its terms, the agreement expires upon the later of (i)20 years after thefirst commercial sale of the licensed technology thereunder and (ii) expiration of the last valid claim under the patent rights. The Company incurredno expense from this agreement during each of thethree months ended* March 31, 2024* and2023, respectively. As of* March 31, 2024*, the Company has incurred and paid approximately $25,000 toward this commitment.

Contract Development and Manufacturing Organization

Genprex entered into athree-year development services agreement in* July 2022,amended in each of January 2023and March 2023,with a contract development and manufacturing organization to manufacture good manufacturing practices (“GMP”) grade materials for use in the Company’s clinical trials with a projected total cost of approximately $4.5 million. The Company incurred $0 and $2.3 million of expense from this agreement during thethree* months ended* March 31, 2024* and2023, respectively. As of* March 31, 2024*, the Company have paid approximately $2.6 million toward this commitment.

Contingencies

From time to time, the Company* maybecome subject to threatened and/or asserted claims arising in the ordinary course of its business. Management isnot* aware of any matters, either individually or in the aggregate, that are reasonably likely to have a material impact on the Company’s financial condition, results of operations or liquidity.

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Note8 - Subsequent Events

Share Issuance

On* April 1, 2024,Genprex issued 5,000 shares of its common stock to the Chairman of its Scientific Advisory Board in consideration for services. On April 15, 2024,Genprex issued 171,112 shares of its common stock upon the exercise of pre-funded warrants by an investor associated with the March 2024*offering.

Departure and Appointment of a Named Executive Officer

On* May 8, 2024,the Company announced the passing of Rodney Varner, the President, Chief Executive Officer, and Chairman of the board of directors of the Company. The Company’s board of directors appointed Ryan Confer, Chief Financial Officer of Genprex since2016,* to serve as President and Chief Executive Officer of Genprex (in addition to his position as Chief Financial Officer of Genprex), effective immediately, consistent with the Company’s transition plan.

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