Genprex Inc

GENPREX, INC.

MARCH 31, 2025

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® gene therapy (generic name:quaratusugene ozeplasmid), 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 multimodal effects on cancer cells. It harms the metabolism of cancer cells, which leads to reduced cancer cell growth. It has a mechanism of action whereby it decreases tumor glucose metabolism, 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 increases the immune response against cancer cells. In preclinical studies, REQORSA has been shown to be complementary with targeted drugs and immunotherapies. The Company’s strategy is to develop REQORSA in combination with currently 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.

TheTUSC2 gene, which is the key component of REQORSA and plays a vital role in cancer suppression and normal cell metabolism, 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”). The Company believes that its ONCOPREX Delivery System allows for the delivery of a number of cancer-fighting tumor suppressor 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,the Company entered into a sponsored research agreement with MD Anderson to support further preclinical studies ofTUSC2* and other tumor suppressor genes. Additionally, the Company is collaborating with MD Anderson to discover, develop and utilize biomarkers to select the patient population most likely to respond to REQORSA and enable decisions on progression of its drug candidates to the next phase of development. MD Anderson is currently analyzing biomarkers that would indicate lack of response in lung cancer that could enrich the Company’s population of responders in its clinical trials and enhance patient screening and enrollment in order to increase the likelihood of potential success of the Acclaim studies for the Company.

Acclaim –1: The Company currently is 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 on treatment with Tagrisso or Tagrisso-containing regimens. 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. There werethree patients originally enrolled in the Phase1 dose escalation portion of the study who had prolonged progression-free survival (“PFS”). One patient attained a partial remission after thesecond course of REQORSA and Tagrisso and has maintained this response through49 courses of treatment (approximately36 months) and continues to receive REQORSA and Tagrisso treatment to date. Asecond patient had stable disease without disease progression through32 courses of treatment (approximately24 months) but recently had disease progression and isno longer receiving treatment. Athird patient had stable disease without disease progression through14 courses of treatment (approximately10 months) before disease progression and isno longer receiving treatment. Genprex opened the Phase2a expansion portion of the study and enrolled and dosed thefirst patient in* January 2024.The initial trial design of the Phase2a* expansion portion of the study includedtwo cohorts with half being patients who received only prior Tagrisso treatment and the other half being patients who received prior Tagrisso treatment and chemotherapy. However, as previously announced in* August 2024,based on resource prioritization and to focus on the patients for whom REQORSA is most likely to show a benefit, the Company decided to limit its enrollment efforts moving forward to patients who received only prior Tagrisso treatment and cease enrollment of thesecond* cohort (patients who received prior Tagrisso treatment and chemotherapy). However, noting that both of the patients with prolonged PFS in the Phase1 portion of the study had previously received both chemotherapy and Tagrisso, in* February 2025,the Company amended the protocol to allow entry of patients progressing on Tagrisso or Tagrisso-containing regimens. The Phase2a* expansion portion of the trial, is now expected to enroll approximately33 patients; all of whom have progressed on Tagrisso or Tagrisso-containing regimens. The Phase2b randomized portion of the study, in which patients progressing on prior Tagrisso treatment will be randomized1:1 to either REQORSA and Tagrisso combination therapy or to platinum-based chemotherapy, will remain unchanged. There will be an interim analysis following the treatment of19 patients in the Phase2a portion of the Acclaim-1 study. The Company expects to complete the enrollment of thefirst 19 patients for interim analysis in the Phase2a expansion portion of the study by the end of2025 and expects the interim analysis in thefirst half of2026.

The 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 on Tagrisso treatment.

The Phase2a expansion portion of the Acclaim-1 study provides the Company the advantage of early insight into drug effectiveness in defined and distinct patient populations at the maximum tolerated dose (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 the study.

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Acclaim –2: The Acclaim-2 trial involved a combination of REQORSA and Merck & Co.’s Keytruda® (pembrolizumab) in patients with late-stage NSCLC whose disease has progressed after treatment with Keytruda. As previously announced in* August 2024,based on a number of factors, including enrollment challenges and delays due to competition for investigators and eligible patients with numerous other trials involving the same patient population, the Company decided to cease enrollment of new patients in the Acclaim-2 trial to prioritize its resources and focus on the othertwo* Acclaim trials in SCLC and NSCLC, respectively. There areno longer any patients receiving study treatment in the Acclaim-2 trial. Although the Acclaim-2 study in patients progressing on Keytruda containing regimens has been closed due to, among other factors, slow enrollment, the Company continues to believe that this combination could be beneficial.

Acclaim –3: The Company is currently enrolling and treating patients in the Phase2 expansion 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 for patients with extensive stage small cell lung cancer (“ES-SCLC”) who developed 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. On* December 16, 2024,the Company announced that it had completed the Phase1* dose escalation portion of the Acclaim-3 clinical trial. Based on full safety data, which showedno DLTs, the Acclaim-3 Safety Review Committee (“Acclaim-3 SRC”) determined that theRP2D of REQORSA will be0.12 mg/kg, which was the highest dose level delivered in the Phase1 portion of the trial, and approved the opening of the Phase2 expansion portion of the trial. The Company anticipates that the Phase2 expansion portion will enroll approximately50 patients at approximately10 to15 U.S sites. Patients will be treated with REQORSA and Tecentriq until disease progression or unacceptable toxicity is experienced. The primary endpoint of the Phase2 portion is to determine the18-week progression-free survival rate from the time of the start of maintenance therapy with REQORSA and Tecentriq in patients with ES-SCLC. Patients will also be followed for survival. A Phase2 futility analysis will be performed after the25th patient enrolled and treated reaches18 weeks of follow up. The Company expects to complete enrollment of thefirst 25 patients for interim analysis in the Phase2 expansion portion of the study in thesecond half of2025.

The Acclaim-3 clinical trial has received FDA Fast Track Designation for this patient population and Acclaim-3 has also received an FDA Orphan Drug Designation.

Diabetes Gene Therapy

In diabetes, Genprex has exclusively licensed from the University of Pittsburgh of the Commonwealth System of Higher Education (“University of Pittsburgh” or “UP”) 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. The Company 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, Genprex decided to continue with its planned additional nonclinical studies before requesting regulatory guidance for the IND-enabling studies. The Company is currently working with the University of Pittsburgh on species analyses for the animal models as well as on other regulatory and clinical strategic planning, including the planned initiation of research in Type2 diabetes animal models, following which the Company believes it would be poised to seek further regulatory guidance from the FDA on IND-enabling studies in thesecond half of2025. In* May 2025,following the recent completion of our August 2022sponsored research agreement with UP, we entered into a new sponsored research agreement with UP to study Type1* diabetes and Type2 diabetes in animal models. The new sponsored research agreement also includes a revised research plan to encompass the Company’s most recent technologies to which Genprex originally acquired exclusive rights from UP in* July 2023as amended and restated in the comprehensive New UP License Agreement in February 2025 (as defined and described below). 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 consolidated condensed financial statements included in this Quarterly Report on Form10-Q. In* February 2023,the Company’s research collaborators at UP presented preclinical data in a non-human primate model of Type1* diabetes highlighting the therapeutic potential of GPX-002 at the16th International Conference on Advanced Technologies & Treatments for Diabetes (ATTD2023) in Berlin, Germany. The statistically significant study results showed the treated animals had decreased insulin requirements, increased c-peptide levels, and improved glucose tolerance compared to baseline. In* April 2023,the Company hosted a Key Opinion Leader virtual event entitled “Novel Gene Therapy to Treat Type1* Diabetes,” which discussed preclinical data reported at ATTD2023 supporting gene therapy to treat Type1 diabetes. The Company has also initiated research on a non-viral lipid nanoparticle delivery system that would allow a patient to receive multiple treatments.

Formation of Wholly Owned Subsidiary

On* February 18, 2025,*Genprex announced the formation of a wholly-owned subsidiary, Convergen Biotech, Inc. (“Convergen”). The Company intends to transfer the diabetes program into Convergen in an effort to focus development and commercialization efforts separately from the Company's oncology program.

Capital Requirements, Liquidity and Going Concern Considerations

The Company’s unaudited consolidated 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 consolidated 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 through the end of thesecond quarter of2025. Genprex 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. These unaudited consolidated condensed financial statements donot include any adjustments that might be necessary if Genprex is unable to continue as a going concern.

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Note2 - Summary of Significant Accounting Policies

Genprex’s unaudited consolidated 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 consolidated 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, 2024consolidated condensed balance sheet was derived from the December 31, 2024audited financial statements. Genprex’s unaudited consolidated condensed financial statements should be read in conjunction with the financial statements and notes thereto included in the Company’s2024* Annual Report on Form10-K, filed with the SEC on* April 1, 2025 (the “Form10*-K”).

The accompanying consolidated 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 consolidated 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 consolidated condensed financial statements follows.

Principles of Consolidation

The accompanying unaudited consolidated condensed financial statements, which include the accounts of the Company and its wholly-owned subsidiary, Convergen Biotech, Inc., have been prepared in accordance with US GAAP for interim financial information and with the instructions to Form10-Q and Article10 of Regulation S-X. All significant intercompany balances and transactions are eliminated in consolidation. As of* March 31, 2025*, Convergen Biotech, Inc. has yet to initiate operating activity.

Change in Accounting Principle

During the year ended* December 31, 2024*, the Company changed an accounting principle related to accounting treatment of intellectual property expenditures. Previously, the Company capitalized certain intellectual property costs associated with the filing or maintenance of specific patents, including application costs, filing fees, and patent prosecution, in accordance with ASC350-30. The Company voluntarily changed this accounting principle to expense, rather than capitalize, these intellectual property costs on the basis that the new treatment is favorable.

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 consolidated 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 consolidated 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 consolidated 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 $3,218,303 and $1,351,625 in excess of FDIC insured limits of*$250,000* at* March 31, 2025* and* December 31, 2024*, 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)2,264,652 unexercised options granted by the Company’s board of directors and unexercised warrants to purchase shares of common stock, and (ii)174,200 unvested restricted stock units granted by the Company’s board of directors representing the right upon vesting to receive shares of common stock, in each case as of* March 31, 2025*.

Segments

Operating segments are defined as components of an entity for which separate discrete financial information is made available and that is regularly evaluated by the chief operating decision maker (“CODM”) in making decisions regarding resource allocation and assessing performance. The Company’s CODM is its Chief Executive Officer and the Company manages its operations as a single segment for the purposes of assessing performance and making operating decisions. The Company is focused on pioneering the discovery and development of gene therapies for use in patient populations with unmet medical needs. See “Note8 – Segment Reporting” for additional disclosures related to segment reporting.

Fair Value of Financial Instruments

The carrying amounts reported in the consolidated 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 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 $1,845,948 and $2,046,858 at* March 31, 2025* and* December 31, 2024*, 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. Costs related to filing and pursuing patent applications are expensed as incurred, as recoverability of such expenditures is uncertain. These patent-related legal costs are reported as a component of general and administrative expenses.

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, 2025*, there wereno deemed impairments of the Company’s long-lived assets.

Modification of Equity Classified Warrants

A change in the terms or conditions of a warrant is accounted for as a modification. For a warrant modification accounted for under ASC815, the effect of a modification shall be measured as the difference between the fair value of the modified warrant over and the fair value of the original warrant immediately before its terms are modified, with each measured on the modification date. The accounting for any incremental fair value of the modified warrants over the original warrants is based on the specific facts and circumstances related to the modification. When a modification is directly attributable to an equity offering, the incremental change in fair value of the warrants is accounted for as an equity issuance cost. When a modification is directly attributable to a debt financing, the incremental change in fair value of the warrants is accounted for as a debt discount or debt issuance cost. For all other modifications, the incremental change in fair value is recognized as a deemed dividend.

Recent Accounting Developments

Accounting pronouncements issued butnot effective until after* March 31, 2025*, 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 adopted this guidance as of December 31, 2024,and the adoption hadno* material impact to the Company’s financial position, results of operation, or cash flows. See “Note8 – Segment Reporting” for additional disclosures related to segment reporting.

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, 2025*, Genprex owned or had exclusive license agreements on 13 granted patents and 25 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, the University of Michigan, and the University of Pittsburgh. These patents comprise various therapeutic, diagnostic, technical and processing claims and costs are expensed as incurred. 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 17, 2025,Genprex and the University of Pittsburgh entered into an amended and restated Exclusive License Agreement (the “New UP License Agreement”) to update and consolidate, into a single agreement, prior license agreements and licensed technologies covered by the prior University of Pittsburgh agreements related to a gene therapy for both Type1* diabetes and Type2 diabetes using the genes of thePdx1 and MafA transcription factors controlled by insulin, glucagon and MafB promoters. As of* February 17, 2025,the New UP License Agreement effectuates the termination of, and amends, restates, replaces and supersedes in their entirety, the prior license agreements between Genprex and the University of Pittsburgh which were effective as of February 10, 2020 (as amended August 17, 2022and November 3, 2022),** December 29, 2022and July 14, 2023.Genprex also terminated, effective February 17, 2025,a prior agreement with UP related to a license for macrophage technology dated November 22, 2022.*

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. See “Note7* - Commitments and Contingencies - Commitments - MD Anderson” for information on additional agreements involving MD Anderson licensed rights and technologies.

University of Michigan

On* November 11, 2024,*Genprex and the Regents of the University of Michigan (“UM” or the “University of Michigan”) entered into a Patent License Agreement (“UM License Agreement”), which granted Genprex a worldwide, exclusive license to the University of Michigan’s patent rights in a co-owned patent application relating to the use of REQORSA in combination with ALK-inhibitors for the treatment of ALK-EML4 positive translocated lung cancer.

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Note4 - Equity

Reverse Stock Split

On* February 2, 2024,Genprex completed the1*-for-40 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 the par value. All references in these unaudited consolidated 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 Offering

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 were exercisable immediately upon issuance at an exercise price of $0.0001 per share and expired 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 received 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, 2028for $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 the March 2024offering. As of December 31, 2024*, all of the 1,377,112 * March 2024*Pre-Funded Warrants had been exercised for shares of common stock.

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 the2023* ATM Facility 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. During thethree months ended* March 31, 2025*, the Company sold 13,278,666 shares of common stock for aggregate net proceeds of $6,028,103 under the2023 ATM Facility.

See “Note9 – Subsequent Events – Share Issuances” for a description of the Company’s usage of the2023 ATM Facility after* March 31, 2025resulting in net proceeds of approximately $867,844. As of the filing date of this Quarterly Report on Form10*-Q, the Company doesnot have any remaining capacity under the current prospectus supplement covering the2023 ATM Facility offering, as most recently updated by the Fourth Sticker Supplement filed on* December 20, 2024to reflect the amount of common stock the Company is eligible to sell under General InstructionI.B.6* to Form S-3.

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Stock Issuances

During thethree months ended* March 31, 2025*, Genprex issued (i)5,000 shares of common stock for services provided to the Company valued at $4,505 to the Chairman of its Scientific Advisory Board, (ii)10,027 shares of common stock upon the vesting of restricted stock units (“RSUs”) valued at $3,864 to Company executives, employees, and non-employee service providers, and (iii)13,278,666 shares of common stock sold for aggregate net proceeds of $6,028,103 under the Company’s2023 ATM Facility.

During thethree months ended* March 31, 2024*, the Company issued (i)125 shares of common stock for services provided to the Company valued at $1,170 to the Chairman of our 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.

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, 2025* and* December 31, 2024*.

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 24,154,348 and 10,860,655 shares of its common stock outstanding as of* March 31, 2025* and* December 31, 2024*, respectively.

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Common Stock Purchase Warrants

Common stock purchase warrant activity for thethree months ended* March 31, 2025* and2024, respectively, is as follows:

The Company didnot issue or cancel any warrants during thethree months ended* March 31, 2025*. The Company didnot record any share-based compensation related to warrants during thethree months ended* March 31, 2025*. The Company expects to record $300,000 of share-based compensation based on performance-based vesting in the future with respect to its warrants outstanding as of* March 31, 2025*.

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.

As of* March 31, 2025*, the Company had outstanding warrants to purchase 1,981,079 shares of common stock at a weighted average exercise price of $10.05 that have been issued to various consultants, investors, and placement agents. The warrants are fully vested, are exercisable for a period of up tofive years from the date of issuance, 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 warrants granted via Black-Scholes-Merton pricing models for thethree months ended* March 31, 2024:*

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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, 2024and2025,* the number of shares of common stock reserved for issuance under the2018 Plan was increased by an aggregate of 74,294 and 543,032 shares, respectively. As of* March 31, 2025*, a total of 464,367 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, 2025*.

Stock Options

As of* March 31, 2025*, Genprex had outstanding stock options to purchase 283,573 shares of common stock that have been granted to various executives, employees, non-employee 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 each of thethree months ended* March 31, 2025* or2024.

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The Company didnot issue stock options for thethree months ended* March 31, 2025*. During thethree months ended* March 31, 2025*, the Company cancelled stock options to purchase 63 shares of common stock with an exercise price of $85.60 per share in connection with the termination of an employee.

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.

The weighted average remaining contractual term for the outstanding options at* March 31, 2025* and* December 31, 2024* is 4.86 and 5.11 years, respectively.

Stock option activity for thethree months ended* March 31, 2025* and2024, respectively, is as follows:

Restricted Stock Units

During thethree months ended* March 31, 2025*, the Company (i) granted 80,000 RSUs to non-executive employees, (ii) withheld 1,408 RSUs to cover taxes associated with the vesting of employee issued RSUs, (iii) cancelled 314 RSUs associated with the termination of an employee, and (iv) issued 10,027 shares of common stock associated with the vesting of RSUs to employees.

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.

A summary of the RSU activity under the2018 Plan during thethree ended* March 31, 2025* and2024, 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, 2025*, the Company’s total share-based compensation was $184,773, including approximately $40,000 of R&D expense and $145,000 of G&A expense, respectively, which represents the expected vesting of options or RSUs issued to executives, other employees, board members, and service providers, as well as the issuance of shares to service providers. As of* March 31, 2025*, 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 $157,594. The Company expects to record this stock-based compensation expense over the nextthree years using a graded vesting method. As of* March 31, 2025*, the weighted average term over which these expenses are expected to be recognized is 0.26 years.

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 issued to executives, other employees, and service providers and RSUs issued to executives, other employees, and board members. 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.

As of* March 31, 2025*, 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 $25,312 and $37,390 of expense for matching contributions to the401(k) Plan during thethree months ended* March 31, 2025*, and2024, respectively.

Note6 - Related Party Transactions

Introgen Research Institute

Introgen Research Institute (“IRI”) is a Texas-based technology company formed by Rodney Varner, who prior to his passing in* May 2024,was the Company’s President, Chief Executive Officer and Chairman of the Board and who was 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, 2025* and* December 31, 2024*.

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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 (the* “August 2022SRA”) to sponsor preclinical studies focused on REQORSA andNPRL2* in oncology to resensitize NSCLC and SCLC to targeted therapies and immunotherapies with an initial projected total cost of approximately $2.9 million. On* June 7, 2024,the Company amended the August 2022SRA with MD Anderson to (i) extend the sponsored research program an additionalsix* months, (ii) amend the quarterly budget from approximately $240,000 to $165,000 per quarter, and (iii) amend the total commitment from $2.9 million to approximately $2.76 million. The Company incurred approximately $331,402 of expense from this agreement during thethree months ended* March 31, 2025*. As of* March 31, 2025*, the Company has paid approximately $1.77 million toward this $2.76 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 (“NIH”).

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) aone-time fee in the midfive figures and (iv) certain patent related expenses. The Company incurredno expense for each of thethree months ended* March 31, 2025* and2024, respectively. As of* March 31, 2025*, the Company has paid approximately $370,000 toward the above-described commitment under this agreement.

National Institutes of Health

Genprex has a royalty obligation to the National Institutes of Health 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 $400,000 and $380,000 as of* March 31, 2025* and* December 31, 2024,*respectively, will be recognized if and when it is probable the Company will obtain regulatory approval (the event that triggers the payment obligation).

University of Michigan

On* November 11, 2024,the Company and the University of Michigan entered into the UM License Agreement, which granted Genprex a worldwide, exclusive license to the University of Michigan’s patent rights in a co-owned patent application relating to the use of REQORSA in combination with ALK-inhibitors for the treatment of ALK-EML4 positive translocated lung cancer. Genprex agreed to pay: (i) an initial license issue fee of $30,000, (ii) running low single digit percentage royalties ranging from 1% to 3% of net sales, (iii) minimum annual royalties in a fixed cash amount of $15,000 for2025* and2026, and $30,000 for2027 and each year thereafter during the term of the UM License Agreement, (iv) a tiered double digit percentage share of non-royalty sublicense income ranging from 10% to 40%, and (v) certain potential clinical milestone payments through FDA regulatory approval up to an aggregate of approximately $350,000 in addition to certain potential commercial sales milestones. As of* March**31,* 2025, Genprex has paid approximately $30,000 toward this commitment.

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University of Pittsburgh

Pursuant to the New UP License Agreement dated* February 17, 2025,by and between Genprex and the University of Pittsburgh, Genprex agreed to pay (i) an initial licensing fee of $10,000, (ii) annual maintenance fees of $65,000 for the first,second andthird* years, and $120,000 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 $4,825,000 in milestone payments related to the usage of the licensed 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. As of* March 31, 2025,*the Company has paid approximately $10,000 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 (“CDMO”) to manufacture good manufacturing practices (“GMP”) grade materials for use in the Company’s clinical trials with a projected total cost at inception of approximately $4.5 million. On April 2, 2024,the Company was informed by the CDMO that the CDMO was ceasing certain manufacturing operations subject to the development services agreement. On June 30, 2024,the development services agreement was terminated by mutual agreement and the CDMO agreed to return $1.3 million to the Company andno* additional commitments are obligated or owed by the Company. The Company didnot incur any expense from this agreement during each of thethree months ended* March 31, 2025* and2024, respectively.

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 pending 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.

MARCH 31, 2025

Note8 - Segment Reporting

Operating segments are defined as components of an entity for which separate discrete financial information is made available and that is regularly evaluated by the chief operating decision maker (“CODM”) in making decisions regarding resource allocation and assessing performance. The Company manages its operations as a single segment (the “Segment”) for the purposes of assessing performance and making operating decisions. The CODM of the Segment is the Company’s Chief Executive Officer. The Segment is focused on pioneering the discovery and development of gene therapies for use in patient populations with unmet medical needs. The accounting policies for the Segment are the same as those described in Note2, Summary of Significant Accounting Policies. The CODM assesses the performance of the Segment and decides how to allocate resources based on net loss that is reported on the statements of operations and comprehensive loss. Further, the following represents information about segment loss and significant segment expenses:

(1) Inclusive of $184,773 and $542,715 of stock-based compensation expense for thethree months ended* March 31, 2025* and2024, respectively, and $0 and $2,670 of depreciation and amortization expense for thethree months ended* March 31, 2025* and2024, respectively.

Note9 - Subsequent Events

The Company has evaluated subsequent events through the filing of this Quarterly Report on Form10-Q and determined that there have beenno recognized subsequent events that have occurred that would require adjustments to the Company's disclosures in the consolidated condensed financial statements. The following are nonrecognized subsequent events through the filing of this Quarterly Report on Form10-Q.

Share Issuances

On* April 1,2025, Genprex issued 5,000 shares of its common stock to the Chairman of its Scientific Advisory Board in consideration for services. From April 1, 2025through the date of filing of this Quarterly Report on Form10*-Q, the Company has sold 3,661,788 shares of its common stock for aggregate net proceeds to the Company totaling $867,844 under the2023 ATM Facility. As of the filing date of this Quarterly Report on Form10-Q, the Company doesnot have any remaining capacity under the current prospectus supplement covering the2023 ATM Facility offering, as most recently updated by the Fourth Sticker Supplement filed on* December 20, 2024to reflect the amount of common stock the Company is eligible to sell under General InstructionI.B.6* to Form S-3.

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