Item 7. Management’s Discussion and Analysis of Financial Condition and Results of Operations.
This Management’s Discussion and Analysis of Financial Condition and Results of Operations (“MD&A”) contains certain forward-looking statements. Historical results may not indicate future performance. Our forward-looking statements reflect our current views about future events, are based on assumptions and are subject to known and unknown risks and uncertainties that could cause actual results to differ materially from those contemplated by these statements. Factors that may cause differences between actual results and those contemplated by forward- looking statements include, but are not limited to, those discussed in “Risk Factors.” We undertake no obligation to publicly update or revise any forward-looking statements, including any changes that might result from any facts, events, or circumstances after the date hereof that may bear upon forward-looking statements. Furthermore, we cannot guarantee future results, events, levels of activity, performance, or achievements. All amounts in this report are in United States (“U.S.”) dollars, unless otherwise noted.
Overview
We are a clinical stage gene therapy company pioneering the development of gene-based therapies for large patient populations with unmet medical needs. Our oncology platform utilizes our 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. Our diabetes technology is designed to work in Type 1 diabetes by transforming alpha cells in the pancreas into functional beta-like cells, which can produce insulin but may be distinct enough from beta cells to evade the body’s immune system. In Type 2 diabetes, our technology is believed to work by replenishing and rejuvenating exhausted beta cells that make insulin.
Oncology Platform
Our 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. Our strategy is to develop REQORSA in combination with currently approved therapies, and we believe REQORSA’s unique attributes position it to provide treatments that improve on these current therapies for patients with NSCLC, SCLC, and possibly other cancers.
The TUSC2 gene, which is the key component of REQORSA and plays a vital role in cancer suppression and normal cell metabolism, is one of a series of genes on the short arm of Chromosome 3 whose therapeutic use is covered by our exclusive worldwide licenses from The University of Texas MD Anderson Cancer Center (“MD Anderson”). We believe that our 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 we are in early stages of discovery programs to identify other cancer candidates. In August 2022, we entered into a sponsored research agreement with MD Anderson to support further preclinical studies of TUSC2 and other tumor suppressor genes. As further described in the “Discovery Programs” section of “Part I, Item 1. Business” of this Annual Report on Form 10-K above, since not all patients respond to REQORSA, we have been collaborating with researchers at MD Anderson to identify biomarkers that might predict a strong positive or negative response to REQORSA in patients with lung cancer. This preclinical effort has led to the identification of two proteins whose expression appears to predict response to REQORSA. Validation in specimens from clinical trials will be needed to determine whether these potential biomarkers predict clinical response. We plan to test patient samples from our clinical trials for selected biomarkers to determine if sensitivities exist among our existing patient population in an effort to guide patient selection and improve clinical outcomes.
Acclaim – 1: We currently are enrolling and treating patients in the Phase 2a expansion portion of our Phase 1/2 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 2023 completion of the Phase 1 dose escalation portion of the study, the Acclaim-1 Safety Review Committee (“Acclaim-1 SRC”) approved advancement from the Phase 1 dose escalation portion to the Phase 2a expansion portion of the study. Based on a review of safety data which showed no dose limiting toxicities (“DLTs”), the Acclaim-1 SRC determined the recommended Phase 2 dose (“RP2D”) of REQORSA to be 0.12 mg/kg administered every 21 days. This was the highest dose level delivered in the Phase 1 portion of the study and is twice the highest dose level delivered in our prior clinical trial combining REQORSA with Tarceva® (erlotinib) for the treatment of late-stage lung cancer. There were three patients out of the twelve originally enrolled in the Phase 1 dose escalation portion of the study who had prolonged progression-free survival (“PFS”). One patient attained a partial remission after the second course of REQORSA and Tagrisso and has maintained this response through 60 courses of treatment (approximately 42 months) and this patient continues to receive REQORSA and Tagrisso treatment to date. A second patient had stable disease without disease progression through 32 courses of treatment (approximately 24 months), but then had disease progression and REQORSA treatment was stopped. A third patient had stable disease without disease progression through 14 courses of treatment (approximately 10 months) before disease progression and is no longer receiving treatment. The results of the Phase 1 dose escalation portion of the study were published in Clinical Lung Cancer, a peer-reviewed journal covering various aspects of clinical and translational research of lung cancer, in January 2026. We opened the Phase 2a expansion portion of the study and enrolled and dosed the first patient in January 2024. The Phase 2a expansion portion of the trial is expected to enroll approximately 33 patients; all of whom have progressed on Tagrisso or Tagrisso-containing regimens. There will be an interim analysis following the treatment of 19 patients in the Phase 2a portion of the Acclaim-1 study. The Phase 2b randomized portion of the study, in which patients progressing on prior Tagrisso treatment will be randomized 1:1 to either REQORSA and Tagrisso combination therapy or to platinum-based chemotherapy, remains unchanged. We expect to complete the enrollment of the first 19 patients for interim analysis in the Phase 2a expansion portion of the study in the first half of 2026 and expect the interim analysis in the second half of 2026.
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 Phase 2a expansion portion of the Acclaim-1 study provides us the advantage of early insight into drug effectiveness in defined and distinct patient populations at the maximum tolerated dose (the “MTD”) or RP2D in order to better evaluate efficacy and increase the likelihood of a successful randomized Phase 2 trial which will follow the expansion portion of the study.
83
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, we decided to cease enrollment of new patients in the Acclaim-2 trial to prioritize our resources and focus on the other two Acclaim trials in SCLC and NSCLC, respectively. There are no 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, we continue to believe that this combination could be beneficial.
Acclaim – 3: We are currently enrolling and treating patients in the Phase 2 expansion portion of our Phase 1/2 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 did not 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 December 2024, we announced that we had completed the Phase 1 dose escalation portion of the Acclaim-3 clinical trial. Based on full safety data, which showed no DLTs, the Acclaim-3 Safety Review Committee (“Acclaim-3 SRC”) determined that the RP2D of REQORSA will be 0.12 mg/kg administered every 21 days, which was the highest dose level delivered in the Phase 1 portion of the trial, and approved the opening of the Phase 2 expansion portion of the trial. Although decreases in tumor size are not expected during maintenance therapy with atezolizumab alone, there were two patients out of the six enrolled in the Phase 1 dose escalation portion of the study who had marked decreases in measurable disease. We previously reported that the first patient treated in the Phase 1 dose escalation portion of the Acclaim-3 trial had a partial remission, which is defined as at least a thirty percent (30%) decrease in tumor size, from prior to the start of maintenance therapy to the time of the CT scan performed after two cycles of maintenance therapy. A CT scan performed after four cycles of maintenance therapy (three months), confirmed that the patient still had a 30% decrease in tumor size in measurable lesions; however, one lesion not previously measurable had grown in size, thus leading to a conclusion of disease progression at that time. Another patient in the Phase 1 dose escalation portion of the Acclaim-3 trial had a twenty-three percent (23%) decrease in tumor size from prior to the start of maintenance therapy to the time of the CT scan performed after two cycles of maintenance therapy. This patient received seven cycles of study therapy before progressing after 4.2 months. In addition, one patient in the Phase 1 dose escalation portion of the study achieved an unconfirmed partial remission after 24 cycles of therapy and continues to receive study treatment in the trial after more than 18 months. We anticipate that the Phase 2 expansion portion will enroll approximately 50 patients at approximately 10 to 15 U.S. sites. Patients will be treated with REQORSA and Tecentriq until disease progression or unacceptable toxicity is experienced. The primary endpoint of the Phase 2 portion is to determine the 18-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 Phase 2 futility analysis will be performed after the 25th patient enrolled and treated reaches 18 weeks of follow up. We expect to complete enrollment of the first 25 patients for interim analysis in the Phase 2 expansion portion of the study in the first half of 2026 and expect the interim analysis in the second half of 2026.
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, we have 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 Type 1 and Type 2 diabetes. The same novel approach is used in each of Type 1 and Type 2 diabetes whereby an adeno-associated virus (“AAV”) vector containing the Pdx1 and MafA genes is administered directly into the pancreatic duct. In humans, this can be done with a routine endoscopy procedure. Our diabetes product candidates are currently being evaluated and optimized in preclinical studies at the University of Pittsburgh. GPX-002 is being developed for the treatment of both Type 1 diabetes and Type 2 diabetes. GPX-002 for Type 1 diabetes is designed to work by transforming alpha cells in the pancreas into functional beta-like cells, which can produce insulin but may be distinct enough from beta cells to evade the body’s immune system. In a similar approach, GPX-002 for Type 2 diabetes, where autoimmunity is not at play, is believed to work by replenishing and rejuvenating exhausted beta cells that make insulin. We are currently working with the University of Pittsburgh on species analyses for the animal models as well as other regulatory and clinical strategic planning, including the initiation of research in Type 2 diabetes animal models. In December 2025, we also executed on our strategic goal to submit a meeting request to the FDA by the end of the year to discuss the necessary Investigational New Drug (“IND”)-enabling preclinical studies, an important step before potentially initiating clinical trials in humans. See the “Recent Developments” section in “Part I, Item 1. Business” of this Annual Report on Form 10-K above for more information on our meeting with the FDA which occurred in February 2026. In May 2025, following the completion of our August 2022 sponsored research agreement with UP, we entered into a new sponsored research agreement with UP to study Type 1 diabetes and Type 2 diabetes in animal models. The new sponsored research agreement also includes a revised research plan to encompass our most recent technologies to which we originally acquired exclusive rights from UP in July 2023 as 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 the Pdx1 and MafA transcription factors that can potentially be used for both Type 1 and Type 2 diabetes. See also “Note 7 – Commitments and Contingencies” to our consolidated financial statements included in this Annual Report on Form 10-K.
On February 17, 2025, we and the University of Pittsburgh entered into an amended and restated Exclusive License Agreement (the “New UP License Agreement”), which updated and consolidated into a single agreement our prior license agreements with UP. Pursuant to the New UP License Agreement, UP granted to us a worldwide, exclusive license for certain patents and related technology, collectively referred to as the “Licensed Technology,” and a worldwide, non-exclusive license to use certain related know-how. The Licensed Technology covered by the New UP License Agreement is based on the same general gene therapy approach as covered under our prior license agreements with UP (less the previously-licensed macrophage technology), whereby an adeno-associated virus vector containing the Pdx1 and MafA genes is administered directly into the pancreatic duct. More specifically, the Licensed Technology covered by the New UP License Agreement is related to a gene therapy for both Type 1 diabetes and Type 2 diabetes using the genes of the Pdx1 and MafA transcription factors controlled by insulin, glucagon and MafB promoters.
In February 2023, our research collaborators at UP presented preclinical data in a non-human primate (“NHP”) model of Type 1 diabetes highlighting the therapeutic potential of GPX-002 at the 16th International Conference on Advanced Technologies & Treatments for Diabetes (ATTD 2023) 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, we hosted a Key Opinion Leader virtual event entitled “Novel Gene Therapy to Treat Type 1 Diabetes,” which discussed preclinical data reported at ATTD 2023 supporting gene therapy to treat Type 1 diabetes. In June 2025, our collaboration partners had two presentations at the 2025 American Diabetes Association (“ADA”) 85th Scientific Sessions. Our research collaborators from UP were invited to give an oral presentation highlighting their work in NHP models of Type 1 diabetes. In addition, our contract development and manufacturing organization collaborators presented a poster on a non-viral lipid nanoparticle delivery system that would allow a patient to receive multiple treatments.
Convergen Biotech, Inc.
Additionally, in September 2024, we announced that we were considering various strategic alternatives and opportunities to enhance stockholder value, including evaluating ways to optimize our clinical and research programs and operational strategies, such as our intention to potentially transfer our diabetes clinical development program and our diabetes gene therapy assets into a new, initially wholly-owned subsidiary. In connection with this intended separation of the diabetes clinical development program, in February 2025, we announced that we had formed a wholly-owned subsidiary, Convergen Biotech, Inc. (“Convergen”), to implement this initial step of the reorganization and facilitate the separation of the diabetes program. If, and when, a potential separation is completed, Convergen will focus on developing and commercializing GPX-002. We plan to retain our oncology clinical development programs and other oncology pipeline assets.
Reverse Stock Splits
Effective as of February 2, 2024 and October 21, 2025, we effected reverse stock splits of our issued and outstanding shares of common stock, at respective ratios of one-for-forty (1:40) and one-for-fifty (1:50) (respectively referred to as the “2024 Reverse Stock Split” and “2025 Reverse Stock Split”, and collectively, the “Reverse Stock Splits”). Our common stock continues to trade on The Nasdaq Capital Market under the same GNPX ticker following the Reverse Stock Splits, but following the 2025 Reverse Stock Split was assigned a new CUSIP number, 372446302. All share and per share amounts in this Annual Report on Form 10-K have been adjusted as appropriate to reflect the Reverse Stock Splits (see “Note 2 – Summary of Significant Accounting Policies” to our consolidated financial statements included in this Annual Report on Form 10-K).
Recently Issued Accounting Pronouncements
A description of recently issued accounting pronouncements that may potentially impact our financial position and results of operations is disclosed in Note 2 to our consolidated financial statements appearing in this Annual Report on Form 10-K.
84
Critical Accounting Policies and Significant Judgments and Estimates
Our consolidated financial statements have been prepared in accordance with generally accepted accounting principles in the United States (“US GAAP”). The preparation of these consolidated financial statements requires us to make estimates and assumptions that affect the reported amounts of assets and liabilities and the disclosure of contingent assets and liabilities at the date of the consolidated financial statements, and the reported amounts of expenses incurred during the reporting periods. Our estimates are based on our historical experience and on various other factors that we believe are reasonable under the circumstances, the results of which form the basis for making judgments about the carrying value of assets and liabilities that are not readily apparent from other sources. Actual results may differ from these estimates under different assumptions or conditions.
We believe that the following accounting policies and estimates are the most critical to aid in fully understanding and evaluating our reported financial results, and they require our most difficult, subjective or complex judgments, resulting from the need to make estimates about the effect of matters that are inherently uncertain.
Research and Development Costs
We record accrued expenses for costs invoiced from research and development activities conducted on our behalf by third-party service providers, which include the conduct of preclinical studies and clinical trials and contract research, manufacturing, and testing activities. We record the costs of research and development activities based upon the amount of services provided, and we include these costs in accrued liabilities in the balance sheets and within research and development expense in the statements of operations. These costs are a significant component of our research and development expenses. Purchased materials to be used in future research are valued at cost and capitalized and included in research and development supplies. The costs of materials that were acquired for a particular research and development activity and have no alternative future use are expensed in the period acquired.
We estimate the amount of work completed through discussions with internal personnel and external service providers as to the progress or stage of completion of the services and the agreed-upon fee to be paid for such services. We make significant judgments and estimates in determining the accrued balance in each reporting period. As actual costs become known, we adjust our accrued estimates. Although we do not expect our estimates to be materially different from amounts actually incurred, our understanding of the status and timing of services performed, the number of patients enrolled and the rate of patient enrollment in any of our clinical trials may vary from our estimates and could result in our reporting amounts that are too high or too low in any particular period. Our accrued expenses are dependent, in part, upon the receipt of timely and accurate reporting from contract research organizations (“CROs”) and other third-party service providers.
Income Taxes
Deferred tax assets or liabilities are recorded for temporary differences between financial statement and tax basis of assets and liabilities, using applicable rates in effect for the year in which the differences are expected to reverse. A valuation allowance is recorded if it is more likely than not that a deferred tax asset will not be realized. We have provided a full valuation allowance on our deferred tax assets, which primarily consist of cumulative net operating losses from April 1, 2009 (inception) to December 31, 2025. Due to our history of operating losses since inception and losses expected to be incurred in the foreseeable future, a full valuation allowance was considered necessary.
Impairment of Long-Lived Assets
Management evaluates long-lived assets for impairment whenever events or changes in circumstances indicate that the carrying amount may not be realizable or at a minimum annually during the fourth quarter of the year. If an evaluation is required, the estimated future undiscounted cash flows associated with the asset are compared to the asset’s carrying value to determine if an impairment of such asset is necessary. The effect of any impairment would be to expense the difference between the fair value of such asset and its carrying value based upon discounted cash flows.
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 ASC 815, 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.
85
Components of our Results of Operations and Financial Condition
Operating expenses
We classify our operating expenses into three categories: research and development, general and administrative, and depreciation.
Research and development. Research and development expenses consist primarily of:
● costs related to compliance with drug development regulatory requirements; and
We recognize all research and development costs as they are incurred except those capitalized with alternative further use. Clinical trial costs, contract manufacturing and other development costs incurred by third-parties are expensed as the contracted work is performed.
We expect our research and development expenses to increase in the future as we (i) advance our current and future product candidates into and through clinical trials, (ii) transition some of our manufacturing activities to new vendors for a variety of reasons, such as to incorporate more advanced processes and scale production, including any additional work that has been or may be required to successfully adapt our process to these new processes, (iii) pursue regulatory approval of our current and potential product candidates in the United States and Europe, and (iv) expand our research programs to include new therapies and new therapy combinations. The process of conducting the necessary preclinical and clinical research to obtain regulatory approval is costly and time-consuming. The actual probability of success for our current and potential product candidates may be affected by a variety of factors including the quality of our current and potential product candidates, early clinical data, investment in our clinical program, competition, manufacturing capability and commercial viability, and limited contracted partners. We may never succeed in achieving regulatory approval for any of our current or future product candidates. As a result of the uncertainties discussed above, we are unable to determine the duration and completion costs of our research and development projects or when and to what extent we will generate revenue from the commercialization and sale of our product candidates, if at all. However, we continue to evaluate ways to optimize our clinical and research programs and operational strategies, as part of our ongoing prioritization initiative. Additionally, we are considering various strategic alternatives and opportunities to enhance stockholder value.
General and administrative.General and administrative expense consists of personnel related costs, which include administrative and executive salaries, as well as the costs of professional services, such as accounting and legal, travel, facilities, information technology and other administrative expenses. We expect our general and administrative expense to increase in future periods due to the anticipated growth of our business and related infrastructure as well as accounting, insurance, investor relations, legal, information technology, and other costs associated with being a public company.
Depreciation. Depreciation expense consists of depreciation from our fixed assets consisting of our property, equipment, and furniture. We depreciate our assets over their estimated useful life. We estimate furniture and computer and office equipment to have a five-year life.
86
Results of Operations
Comparison of the Years Ended December 31, 2025 and 2024
The following summarizes our results of operations for the years ended December 31, 2025 and 2024.
Research and Development Expense. Research and development (“R&D”) expense was $9,428,720 for the year ended December 31, 2025 as compared to $10,535,446 for the year ended December 31, 2024. This decrease of $1,106,726, or 11%, is primarily due to (i) reduction in clinical and manufacturing expenses due to closing of the Acclaim-2 clinical trial, (ii) differences in enrollment of the Acclaim-1 and Acclaim-3 clinical trials during each of the periods, and (iv) expansion of expense reduction strategies by leadership to reduce R&D overheads and employee associated expenses that included reducing R&D staff from 9 employees at December 31, 2024 to 7 employees at December 31, 2025.
General and Administrative Expense. General and administrative (“G&A”) expense for the year ended December 31, 2025 was $6,086,899 as compared to $10,632,028 for the year ended December 31, 2024, a decrease of $4,545,129, or 43%. This decrease was primarily due to (i) one-time charges associated with the separation with a former Company executive and changes in accounting policies that resulted in a non-cash expense of approximately $800,000 due to an adjustment of capitalized intellectual property during the year ended December 31, 2024, (ii) a significant reduction in share-based compensation for G&A personnel due to the timing and fair market value of equity awards, and (iii) expansion of expense reduction strategies by leadership to reduce travel expenses, the number of professional service providers and associated expenses, and G&A overheads.
Interest Income. Interest income was $26,900 and $63,574 for the years ended December 31, 2025 and 2024, respectively. This decrease of $36,674 was primarily due to lower cash balances held in interest bearing accounts for the year ended December 31, 2025 as compared to the prior year.
Interest Expense. There was no interest expense for the years ended December 31, 2025 and 2024 because we had no debt obligations. As of December 31, 2025, we had no outstanding debt.
Depreciation Expense. Depreciation expense was $0 and $6,693 for the years ended December 31, 2025 and 2024, respectively. The decrease of $6,693, or 100%, in depreciation was primarily due to the timing of purchases of computer equipment for employees and changes to accounting policies related to depreciation.
Net Loss.We had a net loss of $16,228,953, for the fiscal year ended December 31, 2025 compared to a net loss of $21,111,163 for the fiscal year ended December 31, 2024. The decrease of $4,882,210, or 23%, in net loss due to the implementation of expense reduction strategies by leadership in the starting in the year ended December 31, 2024 and continuing throughout the year ended December 31, 2025, which reduced travel expenses, the number of professional service providers and associated expenses, and reduced headcount and associated overhead of overall Company staff from 15 employees at December 31, 2024 to 13 employees at December 31, 2025.
87
Liquidity and Capital Resources
From inception through December 31, 2025, we have never generated revenue from product sales and have incurred net losses in each year. As of December 31, 2025, we had an accumulated deficit of $171,028,396. We have funded our operations primarily through the sale and issuance of capital stock.
For the year ended December 31, 2024, we (i) sold 153,701 shares of common stock for net proceeds of approximately $6.1 million pursuant to our 2023 ATM Facility (defined below), and (ii) completed a registered direct offering in which we sold (x) 3,300 shares of our common stock, (y) pre-funded warrants exercisable for up to an aggregate of 27,543 shares of our common stock (“March 2024 Pre-Funded Warrants”), and (z) warrants exercisable for up to an aggregate of 30,843 shares of our common stock (“March 2024 Common Warrants”), for net proceeds of approximately $5.9 million. In connection with the March 2024 registered direct offering, we amended certain existing warrants to reduce the exercise price and extend the term thereof. See also “Note 4 - Equity - Registered Direct Offering” to our consolidated financial statements included in this Annual Report on Form 10-K. As of December 31, 2024, all of the 27,543 March 2024 Pre-Funded Warrants had been exercised for shares of common stock.
For the year ended December 31, 2025, we sold (i) 1,602,490 shares of common stock for net proceeds of approximately $10.8 million pursuant to our 2023 ATM Facility, (ii) 772,867 shares of common stock (inclusive of the 23,737 commitment shares issued pursuant to the Purchase Agreement (as defined below)) for aggregate net proceeds of approximately $5.3 million, pursuant to our 2025 ELOC Facility (as defined below), (iii) completed a registered direct offering in which we sold (x) 243,622 shares of our common stock, and (y) warrants exercisable for up to an aggregate of 487,244 shares of our common stock (“October 2025 Private Warrant Shares I”), for net proceeds of approximately $2.5 million, and (iv) completed a registered direct offering in which we sold (x) 377,780 shares of our common stock, and (y) warrants exercisable for up to an aggregate of 755,560 shares of our common stock (“October 2025 Private Warrant Shares II”), for net proceeds of approximately $3.1 million. From January 1, 2026 through the date of filing of this Annual Report on Form 10-K, we sold 5,714,798 shares of common stock for aggregate net proceeds of approximately $13.3 million pursuant to our 2023 ATM Facility.
On June 11, 2025, we entered into an equity line of credit (“ELOC”) purchase agreement, dated June 11, 2025 (the “Purchase Agreement”), with Lincoln Park Capital Fund, LLC (“Lincoln Park”), pursuant to which Lincoln Park committed to purchase from us up to $12.5 million in shares of our common stock (subject to certain conditions and limitations contained in the Purchase Agreement) from time to time at our sole discretion over the 24-month term of the Purchase Agreement (the “2025 ELOC Facility”). Sales of shares of common stock to Lincoln Park under the Purchase Agreement will depend on a variety of factors to be determined by us from time to time, including, among others, market conditions, the trading price of our common stock and our determination as to the appropriate sources of funding for our operations. See also “Note 1 – Description of Business and Basis of Presentation – Capital Requirements, Liquidity and Going Concern Considerations” and “Note 4 - Equity – Equity Line of Credit” to our consolidated financial statements included in this Annual Report on Form 10-K.
On December 13, 2023, we entered into an At The Market (“ATM”) Offering Agreement (the “Sales Agreement”) with H.C. Wainwright & Co., LLC, serving as agent (the “Agent”) with respect to an at-the-market offering program (our “2023 ATM Facility”) under which we may offer and sell through the Agent, from time to time at our sole discretion, up to such number or dollar amount of shares of our common stock (the “Shares”) as registered on the prospectus supplement covering the 2023 ATM Facility offering, as may be amended or supplemented from time to time. We have agreed to pay the Agent a commission equal to three percent (3%) of the gross sales proceeds of any Shares sold through the Agent under the Sales Agreement, and also have provided the Agent with customary indemnification and contribution rights. Currently, we have registered $75 million of Shares to sell under the ATM, of which we have sold approximately $16.4 million and have approximately $58.6 million remaining unsold as of the date of filing of this Annual Report on Form 10-K. See also “Note 1 - Description of Business and Basis of Presentation - Capital Requirements, Liquidity and Going Concern Considerations” and “Note 4 - Equity - At-The-Market Offering” to our consolidated financial statements included in this Annual Report on Form 10-K.
As of December 31, 2025, we had $7,830,855 in cash. Subsequent to year-end 2025, we received net proceeds totaling approximately $13.3 million through the Agent pursuant to our 2023 ATM Facility.
We do not expect to generate revenue from product sales unless and until we successfully complete development of, obtain regulatory approval for and begin to commercialize one or more of our current or future product candidates, which we expect will take a number of years and which is subject to significant uncertainty. Accordingly, we anticipate that we will need to raise additional capital to fund our future operations, which include conducting our Acclaim-1 and Acclaim-3 clinical trials (of which both are currently enrolling) and completing preclinical work for potential other oncology candidates and completing preclinical work and conducting clinical trials for our diabetes program. We expect interim enrollment of the Phase 2a expansion portion of the Acclaim-1 trial to be completed in the first half of 2026. We expect interim enrollment in the Phase 2 dose expansion portion of the Acclaim-3 trial to be completed in the first half of 2026. Until such time as we can generate substantial revenue from product sales, if ever, we expect to finance our operating activities through a combination of equity offerings, drawdowns on our 2023 ATM Facility pursuant to our Sales Agreement with the Agent, sales pursuant to our 2025 ELOC Facility, and debt financings and we may seek to raise additional capital through strategic collaborations or transactions. However, we may be unable to raise additional funds or enter into such arrangements when needed on favorable terms, or at all, which would have a negative impact on our financial condition and could force us to delay, limit, reduce or terminate our research and development programs or commercialization efforts or grant rights to others to develop or market product candidates that we would otherwise prefer to develop and market ourselves. Failure to receive additional funding could cause us to curtail or cease our operations. Furthermore, even if we believe we have sufficient funds for our current or future operating plans, we may seek additional capital due to favorable market conditions or strategic considerations. As a result of the Company’s 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 over the next 12 months, which raises substantial doubt as to the Company’s ability to continue as a going concern.
Based on our current cash, we estimate that we will be able to fund our expenditure requirements for our current operations and planned clinical trial activities into the second quarter of 2027. We have based these estimates on assumptions that may prove to be wrong, and we could utilize our available capital resources sooner than we currently plan due to incorrect assumptions or due to a decision to expand our activities beyond those currently planned. We have experienced delays in clinical trial enrollment as a result of competition for patients and previously experienced delays due to additional time required in connection with our transition to the new third party CDMO and the manufacture of final drug product. Delays in the conduct of our trials could result in utilizing our capital resources sooner without advancing our clinical trials as anticipated.
The following table sets forth the primary sources and uses of cash for the years ended December 31, 2025 and 2024:
Years Ended December 31,
Net cash provided by investing activities — 774,644
Net increase (decrease) in cash and cash equivalents 6,229,195 (5,135,969 )
88
Short Term Cash Requirements
We believe that our existing cash is sufficient to fund our expected short-term needs into the second quarter of 2027, but will need additional fundraising activities and cash on hand by such time. We currently have certain fixed cash obligations with respect to development of materials used in our clinical studies and payment obligations associated with our ongoing conduct and monitoring of our Acclaim clinical trials, and we expect that we will have insufficient cash to cover these requirements through fiscal year 2027 without raising additional working capital. The foregoing conditions raise substantial doubt regarding our ability to continue as a going concern for a period of one year after the date the consolidated financial statements included in this Annual Report are issued. Lack of necessary funds may require us, among other things, to delay, scale back or eliminate some or all of our ongoing and/or planned clinical trials, or research and development programs, or make changes to our operating plan, or curtail or cease operations.
Long Term Cash Requirements
We regularly evaluate our business plans and strategy. These evaluations often result in changes to our business plans and strategy, some of which may be material and significantly change our cash requirements. Ongoing business development activity may require us to use some of our liquidity for an acquisition, or additional capital to fund newly acquired operations. If we raise additional funds by issuing equity securities, our existing security holders will likely experience dilution; and the incurring of indebtedness would result in increased debt service obligations and could require us to agree to operating and financial covenants that could restrict operations.
Our future capital requirements depend on many factors, including, but not limited to:
● the cost of manufacturing our existing and future products;
● the expenses needed to attract and retain skilled personnel;
● the costs associated with being a public company;
89
Cash used in operating activities
Net cash used in operating activities was $15,311,209 and $17,922,566 for the years ended December 31, 2025 and 2024, respectively. The decrease of $2,611,357, or 15%, in net cash used in operating activities in 2025 was primarily due (i) the closing of the Acclaim-2 clinical trial and associated reductions in clinical and manufacturing related expenses, and (ii) the expansion of expense reduction strategies by leadership, which reduced travel expenses, the number of professional service providers and associated expenses, and reduced headcount and associated overhead of overall Company staff from 15 employees at December 31, 2024 to 13 employees at December 31, 2025.
Cash used in investing activities
Net cash provided by investing activities was $0 for the year ended December 31, 2025, compared to net cash used in investing activities of $774,644 for the year ended December 31, 2024, or a net change of $774,644. This difference in period-over-period net cash used in investing activities was primarily due to changes in accounting policy, for the year ended December 31, 2024, that reduced previously capitalized intellectual property.
Cash provided by financing activities
Net cash provided by financing activities was $21,540,404 and $12,011,953 for the years ended December 31, 2025 and 2024, respectively. The increase of $9,528,451, or 79%, in net cash provided by financing activities was primarily due to (i) differences in financing strategies used, (ii) differences in amounts raised by sales of our securities in capital raising activities, and (iii) differences in interest rates during the years ended December 31, 2025 and 2024, respectively.
Item 7A. Quantitative and Qualitative Disclosures About Market Risk.
As a smaller reporting company, we are not required to provide the information called for by this item.
Item 8. Financial Statements and Supplementary Data.
The financial statements and supplementary data required by this item are included after Part IV of this Annual Report on Form 10-K beginning on page F-1.
Item 9. Changes in and Disagreements With Accountants on Accounting and Financial Disclosure.
Not applicable.
90
Item 9A. Controls and Procedures.
Evaluation of Disclosure Controls and Procedures
As required by Rules 13a-15(b) and 15d-15(b) of the Exchange Act, our management with the participation of our Chief Executive Officer and Chief Financial Officer, evaluated the effectiveness of our disclosure controls and procedures as of December 31, 2025. The term “disclosure controls and procedures” as defined in Rules 13a-15(e) and 15d-15(e) under the Exchange Act, means controls and other procedures of a company that are designed to ensure that information required to be disclosed by a company in the reports that it files or submits under the Exchange Act is recorded, processed, summarized and reported, within the time periods specified in the SEC’s rules and forms. Disclosure controls and procedures include, without limitation, controls and procedures designed to ensure that information required to be disclosed by a company in the reports that it files or submits under the Exchange Act is accumulated and communicated to a company’s management, including its principal executive and principal financial officer (currently the same person following the passing of Mr. Varner, the Company’s former President, Chief Executive Officer and Chairman of the Board of Directors, on May 7, 2024), as appropriate to allow timely decisions regarding required disclosure. Management recognizes that any controls and procedures, no matter how well designed and operated, can provide only reasonable assurance of achieving their objectives, and management necessarily applies its judgment in evaluating the cost-benefit relationship of possible controls and procedures. Based on the evaluation of our disclosure controls and procedures as of December 31, 2025, our Chief Executive Officer and Chief Financial Officer concluded that, as of such date, our disclosure controls and procedures were not effective due to material weaknesses in our internal control over financial reporting related to a lack of segregation of duties between accounting and other functions and the absence of sufficient depth of in-house accounting personnel with the ability to properly account for complex transactions.
Management’s Report on Internal Control over Financial Reporting
Our principal executive officer and principal accounting and financial officer are responsible for establishing and maintaining adequate internal control over financial reporting, as such term is defined in Exchange Act Rules 13a-15(f) and 15d-15(f). Management conducted an assessment of the effectiveness of our internal control over financial reporting as of December 31, 2025. In making this assessment, management used the criteria described in Internal Control-Integrated Framework (2013) issued by the Committee of Sponsoring Organizations of the Treadway Commission (COSO). Our management concluded that our internal controls over financial reporting were, and continue to be, ineffective as of December 31, 2025 due to material weaknesses in our internal controls due to the lack of segregation of duties and insufficient depth of in-house accounting personnel.
It should be noted that any system of controls, however well designed and operated, can provide only reasonable and not absolute assurance that the objectives of the system are met. In addition, the design of any control system is based in part upon certain assumptions about the likelihood of certain events. Because of these and other inherent limitations of control systems, there can be no assurance that any design will succeed in achieving its stated goals under all potential future conditions, regardless of how remote.
In light of the material weaknesses described below, we performed additional analysis and other post-closing procedures to ensure our consolidated financial statements were prepared in accordance with generally accepted accounting principles. Accordingly, we believe that the consolidated financial statements included in this report fairly present, in all material respects, our financial condition, results of operations and cash flows for the periods presented.
During the year ended December 31, 2025 and as our operational activities increased, management determined and continues to determine that it does not have sufficient segregation of duties within its accounting functions nor does it have sufficient depth of in-house accounting personnel with the ability to properly account for complex transactions, which are basic internal controls. Due to our size, segregation of all conflicting duties may not always be possible and may not be economically feasible. However, to the extent possible, the initiation of transactions, the custody of assets and the recording of transactions should be performed by separate individuals. Our size and nature also do not allow for our accounting staff to have depth of expertise in all areas that might be desirable, such as expertise in accounting for a variety of complex transactions. Management evaluated the impact of our failure to maintain effective segregation of duties and sufficient depth of personnel on our assessment of our internal control over financial reporting and has concluded that these control deficiencies represent material weaknesses.
91
Remediation Plans
Management is actively engaged in remediation efforts to address the material weaknesses identified in management’s evaluation of internal controls and procedures. The remediation efforts, which have been or are in the process of being implemented, are intended to address the identified material weaknesses and include:
During the year ended December 31, 2025, we took actions to remediate the material weaknesses relating to our internal controls over financial reporting including:
As management continues to evaluate and work to improve its internal control over financial reporting, we may take additional measures to address control deficiencies, or we may modify certain of the remediation measures described above. While remediation efforts are active, management requires additional time to demonstrate the operating effectiveness of our remediation efforts. The material weaknesses cannot be considered remediated until the applicable remedial controls operate for a sufficient period of time and management has concluded, through testing, that these controls are operating effectively.
Changes in Internal Control over Financial Reporting
Except as described above, there were no changes in our internal control over financial reporting during the year ended December 31, 2025 that have materially affected, or are reasonably likely to materially affect, our internal control over financial reporting.
Inherent Limitations of Disclosure Controls and Internal Control over Financial Reporting
Because of their inherent limitations, our disclosure controls and procedures and our internal control over financial reporting may not prevent material errors or fraud. A control system, no matter how well conceived and operated, can provide only reasonable, not absolute, assurance that the objectives of the control system are met. The effectiveness of our disclosure controls and procedures and our internal control over financial reporting is subject to risks, including that the controls may become inadequate because of changes in conditions or that the degree of compliance with our policies or procedures may deteriorate.
92
Item 9B. Other Information.
Rule 10b5-1 Trading Arrangements and Non-Rule 10b5-1 Trading Arrangements
During the fiscal quarter ended December 31, 2025, none of our officers or directors, as those terms are defined in Rule 16a-1(f), adopted or terminated a “Rule 10b5-1 trading arrangement” or a “non-Rule 10b5-1 trading arrangement,” as those terms are defined in Item 408 of Regulation S-K.
Item 9C. Disclosure Regarding Foreign Jurisdictions that Prevent Inspections.
Not applicable.
93
PART III
Item 10. Directors, Executive Officers and Corporate Governance.
The remaining information required by this Item 10, to the extent not set forth herein, is incorporated herein by reference to the information that will be contained in our definitive proxy statement (the “Proxy Statement”) for the 2026 annual meeting of stockholders (the “Annual Meeting”), which is expected to be filed not later than 120 days after the end of our fiscal year ended December 31, 2025.
ETHICS CODE
We have adopted a written Code of Business Conduct and Ethics, or Ethics Code, that applies to all of our officers, directors and employees, including our principal executive officer, principal financial officer, principal accounting officer or controller, or persons performing similar functions. A current copy of our Ethics Code is available on our website at www.genprex.com/investors/corporate-governance. We may satisfy the disclosure requirement under Item 5.05 of Form 8-K regarding a substantive amendment to, or a waiver from, a provision of our Ethics Code that applies to our principal executive officer, principal financial officer, principal accounting officer or controller, or persons performing similar functions and that relates to any element of the code of ethics definition enumerated in paragraph (b) of Item 406 of the SEC’s Regulation S-K, by posting such information on our website, www.genprex.com, or by filing a Form 8-K.
INSIDER TRADING POLICY
Our Company has an insider trading policy governing the purchase, sale and other dispositions of our Company’s securities that applies to all Company personnel, including directors, officers, employees, other covered persons as well as the Company. We believe that our insider trading policy is reasonably designed to promote compliance with insider trading laws, rules and regulations, and listing standards applicable to the Company. A copy of our insider trading policy is filed as Exhibit 19.1 to this Form 10-K.
Item 11. Executive Compensation.
The information required by this Item 11 is incorporated herein by reference to the information that will be contained in our Proxy Statement for the Annual Meeting.
Item 12. Security Ownership of Certain Beneficial Owners and Management and Related Stockholder Matters.
The information required by this Item 12 is incorporated herein by reference to the information that will be contained in our Proxy Statement for the Annual Meeting.
Item 13. Certain Relationships and Related Transactions, and Director Independence.
The information required by this Item 13 is incorporated herein by reference to the information that will be contained in our Proxy Statement for the Annual Meeting.
Item 14. Principal AccountantFees and Services.
The information required by this Item 14 is incorporated herein by reference to the information that will be contained in our Proxy Statement for the Annual Meeting.
PART IV
Item 15. Exhibits and Financial Statement Schedules.
(a)(1) Financial statements.
The financial statements and supplementary data required by this item begin on page F-1.
(a)(2) Financial Statement Schedules.
All schedules are omitted because the required information is inapplicable or the information is presented in the financial statements and the related notes.
(a)(3) Exhibits.
94
EXHIBIT INDEX
Exhibit Number Description of Exhibit
4.24 * Description of Registrant’s Securities.
95
Exhibit Number Description of Exhibit
96
Exhibit Number Description of Exhibit
97
Exhibit Number Description of Exhibit
21.1 * Subsidiaries of the Registrant.
101.INS * Inline XBRL Instance Document.
101.SCH * Inline XBRL Taxonomy Extension Schema Document.
101.CAL * Inline XBRL Taxonomy Extension Calculation Linkbase Document.
101.DEF * Inline XBRL Taxonomy Extension Definition Linkbase Document.
101.LAB * Inline XBRL Taxonomy Extension Label Linkbase Document.
101.PRE * Inline XBRL Taxonomy Extension Presentation Document.
* Filed herewith.
** Furnished herewith.
+ Indicates management contract or compensatory plan.
Item 16. Form 10–K Summary.
None.
98
SIGNATURES
Pursuant to the requirements of Section 13 or 15(d) of the Securities Exchange Act of 1934, the registrant has duly caused this annual report on Form 10-K to be signed on its behalf by the undersigned, thereunto duly authorized.
GENPREX, INC.
Date: March 30, 2026 By: /s/ Ryan M. Confer
Ryan M. Confer
President, Chief Executive Officer and Chief Financial Officer
(Principal Executive Officer and Principal Financial and Accounting Officer)
Pursuant to the requirements of the Securities Exchange Act of 1934, this report has been signed below by the following persons on behalf of the registrant and in the capacities and on the dates indicated.
Signature Title Date
/s/ Brent M. Longnecker Member of the Board of Directors March 30, 2026
Brent M. Longnecker
Jose Antonio Moreno Toscano
/s/ Will R. Wilson, Jr. Member of the Board of Directors March 30, 2026
Will R. Wilson, Jr.
99
GENPREX, INC.
INDEX TO CONSOLIDATED FINANCIAL STATEMENTS
Report of Independent Registered Public Accounting Firm (PCAOB ID # 100) F-2
Consolidated Balance Sheets as of December 31, 2025 and 2024 F-4
Notes to Consolidated Financial Statements F-8
F-1
Report of Independent Registered Public Accounting Firm
To the Board of Directors and Stockholders of
Genprex, Inc:
Opinion on the Consolidated Financial Statements
We have audited the accompanying consolidated balance sheets of Genprex, Inc., (the “Company”) as of December 31, 2025 and 2024, and the related consolidated statements of operations, changes in stockholders’ equity, and cash flows for each of the two years in the period ended December 31, 2025, and the related notes (collectively referred to as the “consolidated financial statements”). In our opinion, the consolidated financial statements present fairly, in all material respects, the financial position of Genprex, Inc., as of December 31, 2025 and 2024, and the results of its operations and its cash flows for each of the two years in the period ended December 31, 2025, in conformity accounting principles generally accepted in the United States of America.
Substantial Doubt About the Company’s Ability to Continue as a Going Concern
The accompanying consolidated financial statements have been prepared assuming that the Company will continue as a going concern. As discussed in Note 1 to the consolidated financial statements, the Company has an accumulated deficit at December 31, 2025 and, since inception, has suffered significant operating losses and negative cash flows from operations that raise substantial doubt about its ability to continue as a going concern. Management's plans in regard to these matters are also described in Note 1. The consolidated financial statements do not include any adjustments that might result from the outcome of this uncertainty.
Basis for Opinion
These consolidated financial statements are the responsibility of the entity’s management. Our responsibility is to express an opinion on these consolidated financial statements based on our audits. We are a public accounting firm registered with the Public Company Accounting Oversight Board (United States) ("PCAOB") and are required to be independent with respect to Genprex, Inc., in accordance with the U.S. federal securities laws and the applicable rules and regulations of the Securities and Exchange Commission and the PCAOB.
We conducted our audits in accordance with the standards of the PCAOB. Those standards require that we plan and perform the audit to obtain reasonable assurance about whether the financial statements are free of material misstatement, whether due to error or fraud. Genprex, Inc., is not required to have, nor were we engaged to perform, an audit of its internal control over financial reporting. As part of our audits we are required to obtain an understanding of internal control over financial reporting but not for the purpose of expressing an opinion on the effectiveness of the entity’s internal control over financial reporting. Accordingly, we express no such opinion.
Our audits included performing procedures to assess the risks of material misstatement of the financial statements, whether due to error or fraud, and performing procedures that respond to those risks. Such procedures included examining, on a test basis, evidence regarding the amounts and disclosures in the consolidated financial statements. Our audits also included evaluating the accounting principles used and significant estimates made by management, as well as evaluating the overall presentation of the consolidated financial statements. We believe that our audits provide a reasonable basis for our opinion.
Critical Audit Matters
The critical audit matters communicated below are matters arising from the current period audit of the consolidated financial statements that were communicated or required to be communicated to the audit committee and that: (1) relate to accounts or disclosures that are material to the consolidated financial statements and (2) involved our especially challenging, subjective, or complex judgments. The communication of critical audit matters does not alter in any way our opinion on the consolidated financial statements, taken as a whole, and we are not, by communicating the critical audit matters below, providing separate opinions on the critical audit matters or on the accounts or disclosures to which they relate.
Accounting for Accrued Research and Development Costs
Critical Audit Matter Description
The Company records accrued expenses for estimated costs of research and development activities conducted by third-party service providers, which include the conduct of preclinical studies and clinical trials, and contract manufacturing activities. The Company records the estimated costs of research and development activities based upon the estimated amount of services provided and included the costs incurred but not yet invoiced within other accrued liabilities in the consolidated balance sheet and within research and development expense in the consolidated statement of operations. These costs can be a significant component of the Company’s research and development expenses.
F-2
The Company estimates the amount of work completed through discussions with internal personnel and external service providers as to the progress of the services and the agreed-upon fee to be paid for such services. The Company makes estimates in determining the accrued balance in each reporting period. Clinical trial-related contracts vary in duration, and may be for a fixed amount, based on the achievement of certain contingent events or deliverables, a variable amount based on actual costs incurred, capped at a certain limit, or contain a combination of these elements. Estimates include costs associated with services provided by contract organizations for preclinical and clinical development and manufacturing of the Company’s product candidates. In the case of clinical trials, the Company relies on estimates of the progress of the clinical trials and related expenses incurred. As actual costs become known, the Company adjust its accrued estimates.
We identified accrued research and development costs as a critical audit matter given the estimation involved in accounting for accrued research and development costs, as well as the material weaknesses identified by the Company in its internal controls over financial reporting. This required extensive audit effort related to the estimation of accrued research and development costs.
How the Critical Audit Matter Was Addressed in the Audit
Our audit procedures related to accrued research and development costs included the following: we obtained an understanding through inquiries and walkthrough procedures and evaluated the design and implementation of controls over the estimation of accrued preclinical studies, clinical trials, and manufacturing expenses. We also read a sample of research, collaboration, and manufacturing agreements and contracts, as well as amendments thereto. We performed a retrospective review of accruals to determine the reasonableness of management’s estimation process.
We also evaluated publicly available information (such as press releases and investor presentations) and board of directors’ materials regarding the status of preclinical studies, clinical trials, and manufacturing activities. For a selection of agreements and contracts, we compared the amount of accrual at the end of the prior period to current year activity and evaluated the accuracy of the Company’s estimation methodology.
For the selection of agreements, we obtained a written confirmation of the status of clinical trials and manufacturing from the Company’s third-party service providers. We also made selections of specific amounts recognized as research and development expense as well as those recognized as accrued expenses to evaluate management’s estimate of the vendor’s progress.
/s/ WithumSmith+Brown, PC
We have served as Genprex, Inc.’s auditor since 2023.
East Brunswick, New Jersey
March 30, 2026
PCAOB ID Number 100
F-3
Genprex, Inc.
Consolidated Balance Sheets
Year Ended
December 31,
Assets
Current assets:
Property and equipment, net — —
Liabilities and Stockholders' Equity
Current liabilities:
Non-current liabilities:
Derivative liabilities 22,500 —
Commitments and contingencies (Note 7)
Stockholders' equity:
See accompanying notes to the consolidated financial statements.
F-4
Genprex, Inc.
Consolidated Statements of Operations
Year Ended
December 31,
Operating expenses:
Depreciation $ — $ 6,693
Other financing costs (739,935 ) —
Realized and unrealized loss (299 ) (570 )
Deemed dividend related to warrant modification — (277,119 )
Weighted average number of common shares — basic and diluted 932,730 80,139
See accompanying notes to the consolidated financial statements.
F-5
Genprex, Inc.
Consolidated Statements of Changes in Stockholders’ Equity
Common Stock
Shares Amount Additional Paid-In Capital Accumulated Deficit Total
RSUs conversion to common stock 633 1 (2 ) — (1 )
Deemed dividend related to warrant modification — — (277,119 ) — (277,119 )
Issuance of common stock for services 400 — 7,948 — 7,948
RSUs conversion to common stock 1,785 2 (2 ) — —
See accompanying notes to the consolidated financial statements.
F-6
Genprex, Inc.
Consolidated Statements of Cash Flows
Year Ended
December 31,
Cash flows from operating activities:
Adjustments to reconcile net loss to net cash used in operating activities:
Share-based compensation and issuance of stock for services 312,835 3,302,982
Non cash financing costs 739,935 —
Changes in operating assets and liabilities:
Cash flows from investing activities:
Disposals of property and equipment — 1,166
Reductions to intellectual property — 773,478
Net cash provided by investing activities — 774,644
Cash flows from financing activities:
Net increase (decrease) in cash and cash equivalents 6,229,195 (5,135,969 )
Supplemental schedule of non-cash investing and financing activities:
Deemed dividend related to warrant modification $ - $ (277,119 )
See accompanying notes to the consolidated financial statements.
F-7
Genprex, Inc.
Notes to Consolidated Financial Statements
December 31, 2025
Note 1 – Description of Business and Basis of Presentation
Genprex, Inc. (“Genprex” or the “Company”), 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 Type 1 diabetes by transforming alpha cells in the pancreas into functional beta-like cells, which can produce insulin but may be distinct enough from beta cells to evade the body’s immune system. In Type 2 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.
The
TUSC2 gene, which is the key component of REQORSA and plays a vital role in cancer suppression and normal cell metabolism, is
one of a series of genes on the short arm of Chromosome
3 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 of
TUSC2 and other tumor suppressor genes. As further described in the “Discovery Programs” section of “Part I, Item
1. Business” of this Annual Report on Form
10-K above, since
not all patients respond to REQORSA, the Company has been collaborating with researchers at MD Anderson to identify biomarkers that might predict a strong positive or negative response to REQORSA in patients with lung cancer. This preclinical effort has led to the identification of
two proteins whose expression appears to predict response to REQORSA. Validation in specimens from clinical trials will be needed to determine whether these potential biomarkers predict clinical response. The Company plans to test patient samples from our clinical trials for selected biomarkers to determine if sensitivities exist among the Company’s existing patient population in an effort to guide patient selection and improve clinical outcomes.
Acclaim –
1: The Company currently is enrolling and treating patients in the Phase
2a expansion portion of its Phase
1/2 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 2023 completion of the Phase
1 dose escalation portion of the study, the Acclaim-
1 Safety Review Committee (“Acclaim-
1 SRC”) approved advancement from the Phase
1 dose escalation portion to the Phase
2a expansion portion of the study. Based on a review of safety data which showed
no dose limiting toxicities (“DLTs”), the Acclaim-
1 SRC determined the recommended Phase
2 dose (
“RP2D”) of REQORSA to be
0.12 mg/kg administered every
21 days. This was the highest dose level delivered in the Phase
1 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 were
three patients out of the
twelve originally enrolled in the Phase
1 dose escalation portion of the study who had prolonged progression-free survival (“PFS”). One patient attained a partial remission after the
second course of REQORSA and Tagrisso and has maintained this response through
60 courses of treatment (approximately
42 months) and this patient continues to receive REQORSA and Tagrisso treatment to date. A
second patient had stable disease without disease progression through
32 courses of treatment (approximately
24 months), but then had disease progression and REQORSA treatment was stopped. A
third patient had stable disease without disease progression through
14 courses of treatment (approximately
10 months) before disease progression and is
no longer receiving treatment. The results of the Phase
1 dose escalation portion of the study were published in
Clinical Lung Cancer, a peer-reviewed journal covering various aspects of clinical and translational research of lung cancer, in
January 2026. Genprex opened the Phase
2a expansion portion of the study and enrolled and dosed the
first patient in
January 2024. The Phase
2a expansion portion of the trial is expected to enroll approximately
33 patients; all of whom have progressed on Tagrisso or Tagrisso-containing regimens. There will be an interim analysis following the treatment of
19 patients in the Phase
2a portion of the Acclaim-
1 study. The Phase
2b randomized portion of the study, in which patients progressing on prior Tagrisso treatment will be randomized
1:1 to either REQORSA and Tagrisso combination therapy or to platinum-based chemotherapy, remains unchanged. The Company expects to complete the enrollment of the
first19 patients for interim analysis in the Phase
2a expansion portion of the study in the
first half of
2026 and expects the interim analysis in the
second half of
2026.
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 Phase 2a 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”) or RP2D in order to better evaluate efficacy and increase the likelihood of a successful randomized Phase 2 trial which will follow the expansion portion of the study.
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 other two Acclaim trials in SCLC and NSCLC, respectively. There are no 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 Phase 2 expansion portion of its Phase 1/2 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 did not 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 December 2024, the Company announced that it had completed the Phase 1 dose escalation portion of the Acclaim-3 clinical trial. Based on full safety data, which showed no DLTs, the Acclaim-3 Safety Review Committee (“Acclaim-3 SRC”) determined that the RP2D of REQORSA will be 0.12 mg/kg administered every 21 days, which was the highest dose level delivered in the Phase 1 portion of the trial, and approved the opening of the Phase 2 expansion portion of the trial. Although decreases in tumor size are not expected during maintenance therapy with atezolizumab alone, there were two patients out of the six enrolled in the Phase 1 dose escalation portion of the study who had marked decreases in measurable disease. The Company previously reported that the first patient treated in the Phase 1 dose escalation portion of the Acclaim-3 trial had a partial remission, which is defined as at least a thirty percent (30%) decrease in tumor size, from prior to the start of maintenance therapy to the time of the CT scan performed after two cycles of maintenance therapy. A CT scan performed after four cycles of maintenance therapy (three months), confirmed that the patient still had a 30% decrease in tumor size in measurable lesions; however, one lesion not previously measurable had grown in size, thus leading to a conclusion of disease progression at that time. Another patient in the Phase 1 dose escalation portion of the Acclaim-3 trial had a twenty-three percent (23%) decrease in tumor size from prior to the start of maintenance therapy to the time of the CT scan performed after two cycles of maintenance therapy. This patient received seven cycles of study therapy before progressing after 4.2 months. In addition, one patient in the Phase 1 dose escalation portion of the study achieved an unconfirmed partial remission after 24 cycles of therapy and continues to receive study treatment in the trial after more than 18 months. The Company anticipates that the Phase 2 expansion portion will enroll approximately 50 patients at approximately 10 to 15 U.S. sites. Patients will be treated with REQORSA and Tecentriq until disease progression or unacceptable toxicity is experienced. The primary endpoint of the Phase 2 portion is to determine the 18-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 Phase 2 futility analysis will be performed after the 25th patient enrolled and treated reaches 18 weeks of follow up. The Company expects to complete enrollment of the first25 patients for interim analysis in the Phase 2 expansion portion of the study in the first half of 2026 and expects the interim analysis in the second half of 2026.
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 Type
1 and Type
2 diabetes. The same novel approach is used in each of Type
1 and Type
2 diabetes whereby an adeno-associated virus (“AAV”) vector containing the
Pdx1 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 for the treatment of both Type
1 diabetes and Type
2 diabetes. GPX-
002 for Type
1 diabetes is designed to work by transforming alpha cells in the pancreas into functional beta-like cells, which can produce insulin but
may be distinct enough from beta cells to evade the body’s immune system. In a similar approach, GPX-
002 for Type
2 diabetes, where autoimmunity is
not at play, is believed to work by replenishing and rejuvenating exhausted beta cells that make insulin. The Company is currently working with the University of Pittsburgh on species analyses for the animal models as well as other regulatory and clinical strategic planning, including the initiation of research in Type
2 diabetes animal models. In
December 2025, the Company also executed on its strategic goal to submit a meeting request to the FDA by the end of the year to discuss the necessary Investigational New Drug (“IND”)-enabling preclinical studies, an important step before potentially initiating clinical trials in humans. See the “Recent Developments” section of “Part I, Item
1. Business” of this Annual Report on Form
10-K above for more information on the Company’s meeting with the FDA which occurred in
February 2026. In
May 2025, following the completion of the Company’s
August 2022 sponsored research agreement with UP, the Company entered into a new sponsored research agreement with UP to study Type
1 diabetes and Type
2 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 2023 as 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 the
Pdx1 and MafA transcription factors that can potentially be used for both Type
1 and Type
2 diabetes. See also “Note
7 – Commitments and Contingencies”.
On
February 17, 2025, the Company and the University of Pittsburgh entered into an amended and restated Exclusive License Agreement (the “New UP License Agreement”), which updated and consolidated into a single agreement the Company’s prior license agreements with UP. Pursuant to the New UP License Agreement, UP granted to the Company a worldwide, exclusive license for certain patents and related technology, collectively referred to as the “Licensed Technology,” and a worldwide, non-exclusive license to use certain related know-how. The Licensed Technology covered by the New UP License Agreement is based on the same general gene therapy approach as covered under the Company’s prior license agreements with UP (less the previously-licensed macrophage technology), whereby an adeno-associated virus vector containing the
Pdx1 and MafA genes is administered directly into the pancreatic duct. More specifically, the Licensed Technology covered by the New UP License Agreement is related to a gene therapy for both Type
1 diabetes and Type
2 diabetes using the genes of the
Pdx1 and MafA transcription factors controlled by insulin, glucagon and MafB promoters.
In
February 2023, the Company’s research collaborators at UP presented preclinical data in a non-human primate (“NHP”) model of Type
1 diabetes highlighting the therapeutic potential of GPX-
002 at the
16th International Conference on Advanced Technologies & Treatments for Diabetes (ATTD
2023) 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 Type
1 Diabetes,” which discussed preclinical data reported at ATTD
2023 supporting gene therapy to treat Type
1 diabetes. In
June 2025, the Company’s collaboration partners had
two presentations at the
2025 American Diabetes Association (“ADA”)
85th Scientific Sessions. The Company’s research collaborators from UP were invited to give an oral presentation highlighting their work in NHP models of Type
1 diabetes. In addition, the Company’s contract development and manufacturing organization collaborators presented a poster on a non-viral lipid nanoparticle delivery system that would allow a patient to receive multiple treatments.
F-
8
Formation of Wholly Owned Subsidiary
On February 18, 2025, Genprex announced the formation of a wholly-owned subsidiary, Convergen Biotech, Inc. (“Convergen”) in connection with a potential separation of the diabetes clinical development program. If, and when, a potential separation is completed, the Company would plan to transfer the diabetes program into Convergen in an effort to focus development and commercialization efforts separately from the Company’s oncology program and other oncology pipeline assets.
Capital Requirements, Liquidity and Going Concern Considerations
The Company’s consolidated 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 has no 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 is not able to timely and successfully raise additional capital, the timing of its clinical trials, financial condition and results of operations may be materially and adversely affected. These consolidated financial statements do not 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 the second quarter of 2027. Genprex has based these estimates, however, on assumptions that may prove 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 and is evaluating various strategies to obtain additional financing, although the Company can give no assurance that its plans or strategies will be effectively implemented in such a way that they will sufficiently alleviate or mitigate the conditions and events noted above.
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 consolidated financial statements do not include any adjustments that might be necessary if Genprex is unable to continue as a going concern.
Note 2 – Summary of Significant Accounting Policies
Genprex’s consolidated financial statements have been prepared in accordance with US GAAP. Accordingly, they do not include all the information and footnotes required by US GAAP for complete financial statements. In the Company’s opinion, the consolidated financial statements include all adjustments (consisting of normal recurring accruals) necessary to make the consolidated financial statements not misleading. The results of operations for any interim periods are not necessarily indicative of results to be expected for the full year. A summary of the Company’s significant accounting policies consistently applied in the preparation of the accompanying consolidated financial statements follows.
Principles of Consolidation
The accompanying consolidated 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. All significant intercompany balances and transactions are eliminated in consolidation. As of December 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 Accounting Standards Codification (“ASC”) 350-30. 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 Splits
On February 2, 2024, Genprex completed a 1-for-40 reverse stock split (“2024 Reverse Split”) of its issued and outstanding shares of common stock. On October 21, 2025, Genprex completed a 1-for-50 reverse stock split (“2025 Reverse Split” and together with the 2024 Reverse Stock Split, the “Reverse Splits”) of its issued and outstanding shares of common stock. The Reverse Splits did not change the number of authorized shares of common stock or par value of the common stock. All references in these consolidated 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 Splits (See “Note 4 – Equity – Reverse Stock Splits”).
Use of Estimates
The preparation of Genprex’s consolidated 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 consolidated financial statements and the reported amounts of expenses during the reporting period. Actual results could differ from those estimates.
F-
9
Cash and Cash Equivalents
Genprex considers all highly liquid short-term investments with an initial maturity of three months or less to be cash equivalents. Any amounts of cash in financial institutions which exceed Federal Deposit Insurance Corporation (“FDIC”) insured limits expose the Company to cash concentration risk. Genprex has cash in a money market account and had $7,580,820 and $1,351,625 in excess of FDIC insured limits of $250,000 at December 31, 2025 and 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) 5,705 unexercised options granted by the Company’s board of directors and warrants to purchase shares of common stock, and (ii) 141,360 unvested restricted stock units to purchase shares of common stock granted by the Company’s board of directors as of December 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 “Note 8 – Segment Reporting” for additional disclosures related to segment reporting.
Fair Value of Financial Instruments
The carrying amounts reported in the balance sheets for cash, money-market savings account, accounts receivable, and accounts payables approximate fair value because of the immediate or short-term maturity of these financial instruments.
ASC 820,Fair Value Measurements and Disclosures, defines fair value, provides a consistent framework for measuring fair value under US GAAP and expands fair value financial statement disclosure requirements. ASC 820’s valuation techniques are based on observable and unobservable inputs. Observable inputs reflect readily obtainable data from independent sources, while unobservable inputs reflect the Company’s market assumptions. ASC 820 classifies these inputs into the following hierarchy:
Level 1: Quoted prices for identical instruments in active markets.
Level 2: Quoted prices for similar instruments in active markets; quoted prices for identical or similar instruments in markets that are not active; and model-derived valuations whose inputs are observable or whose significant value drivers are observable.
Level 3: Instruments with primarily unobservable value drivers.
Property and Equipment
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 to five years. Routine maintenance and repairs are charged to expense as incurred and major renovations or improvements are capitalized.
Research and Development Materials 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 Phase 1/2 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 have no alternative future use are expensed in the period acquired.
Research and development supplies purchased and capitalized for future use were $1,802,228 and $2,046,858 at December 31, 2025 and 2024, respectively.
F-
10
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 the years ended December 31, 2025 and 2024, there were no deemed impairments of the Company’s long-lived assets.
Derivative Liability
The Company evaluates all features contained in financing agreements to determine if there are any embedded derivatives that require separate accounting from the underlying agreement under ASC 815, – Derivatives and Hedging. An embedded derivative that requires separation is accounted for as a separate asset or liability from the host agreement. The derivative asset or liability is accounted for at fair value, with changes in fair value recognized in the statements of operations within the other financing costs line item. The Company determined that certain features under the Equity Line of Credit (see Note 4 – Equity – Equity Line of Credit) qualified as an embedded derivative. The derivative liability is accounted for separately from the Equity Line of Credit Purchase Agreement and is accounted for at fair value. $22,500 has been recorded on the accompanying consolidated balance sheet as of December 31, 2025, related to this derivative liability.
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 ASC 815, 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. The Company recognized a modification of an equity classified warrant as a deemed dividend for the year ended December 31, 2024. There were no modifications of equity classified warrants during the year ended December 31, 2025.
Recent Accounting Developments
Accounting pronouncements issued but not effective until after December 31, 2025 are not expected to have a significant effect on the Company’s financial condition, results of operations, or cash flows.
In December 2023, the Financial Accounting Standards Board (“FASB”) issued Accounting Standards Update (“ASU”) 2023-09,Income Taxes (Topic 740): 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 adopted the standard effective January 1, 2025 and there was no material impact to our consolidated financial statements.
In December 2025, the FASB issued ASU 2025-11,Interim Reporting (Topic 270): Narrow-Scope Improvements, which is intended to clarify the applicability of interim reporting guidance, the types of interim reporting and the form and content of interim GAAP financial statements. ASU 2025-11 will be effective for our fiscal year beginning on September 1, 2028 and we are currently evaluating the impact it may have on our interim condensed consolidated financial statements.
F-
11
Note 3 – Intellectual Property
As of December 31, 2025, Genprex owned or had exclusive license agreements on 15 granted patents and 28 pending patent applications worldwide for technologies developed in-house or by researchers at the National Cancer Institute, New York University, The University of Texas MD Anderson Cancer Center, the University of Texas Southwestern Medical Center, the University of Texas Health Sciences Center at Houston, 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 Type 1 diabetes and Type 2 diabetes using the genes of the Pdx1 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, 2022 and November 3, 2022), December 29, 2022 and 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 “Note 7 - 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.
New York University
On April 25, 2025, Genprex and New York University (“NYU”) entered into a License Agreement (the “NYU License Agreement”), which granted Genprex exclusive patent and commercial rights worldwide relating to Genprex’s lead drug candidate REQORSA for the potential treatment of mesothelioma.
University of Texas Health Sciences Center at Houston
On May 2, 2025, Genprex and the Board of Regents of The University of Texas System on behalf of The University of Texas Health Sciences Center at Houston (“UTHealth Houston” or “UTH”) entered into a Patent and Technology License Agreement (the “UTH License Agreement”), which granted Genprex exclusive patent and commercial rights worldwide relating to Genprex’s lead drug candidate REQORSA for the potential treatment of glioblastoma.
Note 4 – Equity
Reverse Stock Splits
On February 2, 2024, Genprex completed a 1-for-40 Reverse Split of its issued and outstanding shares of common stock. The 2024 Reverse Split did not change the number of authorized shares of common stock or the par value of the common stock. All references in these consolidated 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 2024 Reverse Split.
On October 21, 2025, Genprex completed a 1-for-50 Reverse Split of its issued and outstanding shares of common stock. The 2025 Reverse Split did not change the number of authorized shares of common stock or the par value of the common stock. All references in these consolidated 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 2025 Reverse Split.
Registered Direct Offerings
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) 3,300 shares of common stock, (ii) pre-funded warrants (the “March 2024 Pre-Funded Warrants”) exercisable for up to an aggregate of 27,543 shares of common stock, and (iii) warrants (the “March 2024 Common Warrants”) exercisable for up to an aggregate of 30,843 shares of common stock. The offering price for each share of common stock and accompanying March 2024 Common Warrant was $210.75, and the offering price for each March 2024 Pre-Funded Warrant and accompanying March 2024 Common Warrant was $210.75. The March 2024 Pre-Funded Warrants were exercisable immediately upon issuance at an exercise price of $0.005 per share and expired when exercised in full. The March 2024 Common Warrants are exercisable immediately upon issuance at an exercise price of $204.50 per share and will expire in five years from the date of issuance. The Company received net proceeds of approximately $5.9 million after commissions and expenses, excluding any proceeds received from any exercise of the March 2024 Common Warrants. In connection with the offering, the Company also amended certain existing warrants to purchase up to an aggregate of 3,886 shares of common stock that were previously issued to investors in March 2023 and July 2023, with exercise prices of $2,200.00 and $1,770.00 per share and expiration dates of March 1, 2028 and July 21, 2028 for $6.25 per amended warrant, such that the amended warrants have a reduced exercise price of $204.50 per share and an expiration date of five years from the closing of the March 2024 offering. As of December 31, 2024, all of the 27,543 March 2024 Pre-Funded Warrants had been exercised for shares of common stock.
On October 24, 2025, Genprex completed a registered direct offering priced at-the-market under Nasdaq rules (the “October 2025 Registered Direct Offering I”), pursuant to which the Company issued an aggregate of 243,622 shares of common stock at a purchase price of $11.21 per share. In a concurrent private placement (the “October 2025 Private Placement I”, and together with the October 2025 Registered Direct Offering I, the “October 2025 Financing I”), the Company issued warrants (the “October 2025 Private Warrants I”) exercisable for up to an aggregate of 487,244 shares of common stock (the “October 2025 Private Warrant Shares I”) at an exercise price of $11.00 per share. The October 2025 Private Warrants I are exercisable immediately upon issuance and will expire on December 12, 2027. Also, the Company agreed to issue to H.C. Wainwright & Co., LLC (the “Placement Agent”) or its designees warrants to purchase up to an aggregate of 14,617 shares of common stock. The warrants issued to the Placement Agent or its designees have substantially the same terms as the October 2025 Private Warrants I except that the warrants issued to the Placement Agent or its designees have an exercise price of $14.0125 per share and a termination date of December 12, 2027. The net proceeds of the October 2025 Financing I, after deducting the placement agent’s fees and expenses and other estimated October 2025 Registered Direct Offering I expenses payable by the Company and excluding the net proceeds, if any, from the exercise of the October 2025 Private Warrants I, were approximately $2.5 million. Additionally, if the holders of October 2025 Private Warrants I exercise such warrants in full, the Company would receive additional gross proceeds of approximately $5.4 million.
On October 29, 2025, Genprex completed a registered direct offering priced at-the-market under Nasdaq rules (the “October 2025 Registered Direct Offering II”), pursuant to which the Company issued an aggregate of 377,780 shares of common stock at a purchase price of $9.00 per share. In a concurrent private placement (the “October 2025 Private Placement II”, and together with the October 2025 Registered Direct Offering II, the “October 2025 Financing II”), the Company issued warrants (the “October 2025 Private Warrants II”) exercisable for up to an aggregate of 755,560 shares of common stock (the “October 2025 Private Warrant Shares II”) at an exercise price of $8.75 per share. The October 2025 Private Warrants II are exercisable immediately upon issuance and will expire on December 12, 2027. Also, the Company agreed to issue to H.C. Wainwright & Co., LLC (the “Placement Agent”) or its designees warrants to purchase up to an aggregate of 22,667 shares of common stock. The warrants issued to the Placement Agent or its designees have substantially the same terms as the October 2025 Private Warrants II except that the warrants issued to the Placement Agent or its designees have an exercise price of $11.25 per share and a termination date of December 12, 2027. In addition, in connection with any future exercise of the October 2025 Private Warrants II, the Company has agreed to (A) pay the Placement Agent (i) a cash fee equal to 7.0% of the aggregate gross exercise price paid in cash with respect to the exercise of such warrants and (ii) a management fee equal to 1.0% of the aggregate gross exercise price paid in cash with respect to the exercise of such warrants and (B) issue to Placement Agent or its designees additional placement agent warrants to purchase that number of shares equal to 6.0% of the aggregate number of shares of common stock underlying such October 2025 Private Warrants II that have been exercised. The net proceeds of the October 2025 Financing II, after deducting the placement agent’s fees and expenses and other estimated October 2025 Registered Direct Offering II expenses payable by the Company and excluding the net proceeds, if any, from the exercise of the October 2025 Private Warrants II, were approximately $3.1 million. Additionally, if the holders of October 2025 Private Warrants II exercise such warrants in full, the Company would receive additional net proceeds of approximately $6.1 million.
At-The Market Offering
On December 13, 2023, Genprex entered into an At The Market (“ATM”) Offering Agreement (the “Sales 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 may offer 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 2023 ATM Facility offering, as may be amended or supplemented from time to time. Any Shares offered and sold pursuant to the Sales Agreement will be issued pursuant to the Company’s currently effective shelf Registration Statement on Form S-3 (File No.333-271386) filed with the SEC on April 21, 2023, which was declared effective on June 9, 2023, as may be amended or supplemented from time to time, or pursuant to any new or successor shelf Registration Statement of the Company. The Company has agreed to pay the Agent a commission equal to three percent (3%) of the gross sales proceeds of any Shares sold through the Agent under the Sales Agreement, and also have provided the Agent with customary indemnification and contribution rights. During the year ended December 31, 2025, the Company sold 1,602,490 shares of common stock for aggregate net proceeds of approximately $10.8 million under the 2023 ATM Facility.
See “Note 10 – Subsequent Events – 2023 ATM Facility” for a description of the Company’s usage of the 2023 ATM Facility after December 31, 2025 resulting in net proceeds of approximately $13.3 million.
Equity Line of Credit
On
June 11, 2025, Genprex entered into an equity line of credit (“ELOC”) purchase agreement (the “Purchase Agreement”) with Lincoln Park Capital Fund, LLC (“Lincoln Park”), pursuant to which Lincoln Park committed to purchase up to
$12.5 million in shares of the Company’s common stock (subject to certain conditions and limitations contained in the Purchase Agreement) from time to time at the Company’s sole discretion over the
24-month term of the Purchase Agreement (the
“2025 ELOC Facility”). Sales of shares of common stock to Lincoln Park under the Purchase Agreement will depend on a variety of factors to be determined by the Company from time to time, including, among others, market conditions, the trading price of the common stock and the Company’s determination as to the appropriate sources of funding for its operations. Due to certain pricing and settlement provisions, the Purchase Agreement qualifies as a standby purchase equity agreement and includes an embedded put option and an embedded forward contract. Genprex will account for the Purchase Agreement as a derivative measured at fair value, with changes in fair value recognized in the statements of operations. The put option derivative liability is accounted for on a fair value basis under the provisions of ASC
815 – Derivatives and Hedging. The derivative associated with the Purchase Agreement was deemed de minimis at inception until the Company obtained stockholder approval to issue shares of common stock to Lincoln Park under the Purchase Agreement in excess of the Exchan
ge Cap. The fair value of the ELOC Purchase Agreement contemplated future purchase decisions based on economic considerations and relevant stock issuance rules and limitations and has been determined using a Monte Carlo simulation. The fair value of the ELOC derivative liability was $22,500 at December 31, 2025.
The following table provides the carrying value and fair value of the ELOC derivative liability of the Company measured at fair value on a recurring basis as of
December 31, 2025:
Fair Value Measurement at December 31, 2025
Carrying Value Level 1 Level 2 Level 3
Liabilities:
Totals liabilities measured and recorded at fair value $ 22,500 $ — $ — $ 22,500
The following table provides quantitative information regarding fair value measurements inputs used with respect to the ELOC derivative liability, as of their respective measurement dates:
Closing stock price: $ 1.75
Expected term (in years): 1.50
Risk-free rate: 3.5 %
The Company expenses the difference between the discounted purchase price of the settled forward and the fair value of the shares on the date of settlement as a non-cash financing cost. During the year ended
December 31, 2025, the Company (i) issued
23,737 shares of common stock to Lincoln Park with a value of
$365,550 as commitment shares pursuant to the
2025 ELOC Facility, which was expensed as incurred,
(ii) sold 749,130 shares of common stock to Lincoln Park as purchase shares for aggregate net proceeds of approximately $5.3 million under the 2025 ELOC Facility, and (iii) expensed
$351,883 related to the difference between the discounted purchase price of the settled forward and the fair value of the shares on the date of settlement as a non-cash financing cost
. From January 1, 2026 through the date of filing of this Annual Report on Form 10-K, the Company has not sold shares of common stock to Lincoln Park.
Stock Issuances
During the year ended December 31, 2025, the Company issued (i) 400 shares of common stock for services provided to the Company valued at $7,875 to the Chairman of its Scientific Advisory Board, (ii) 1,785 shares of common stock upon the vesting of restricted stock units (“RSUs”) valued at $21,922 to Company executives, other employees, and non-employee service providers, (iii) 1,602,490 shares of common stock sold for aggregate net proceeds of approximately $10.8 million under the 2023 ATM Facility, (iv) 23,737 shares of common stock issued to Lincoln Park as commitment shares pursuant to the Company’s 2025 ELOC Facility, and (v) 749,130 shares of common stock sold to Lincoln Park as purchase shares for aggregate net proceeds of approximately $5.3 million under the 2025 ELOC Facility.
During the year ended December 31, 2024, Genprex issued (i) 303 shares of common stock for services provided to the Company valued at $27,669 to the Chairman of its Scientific Advisory Board, (ii) 725 shares of common stock to service providers of the Company valued at $179,550, (iii) 633 shares of common stock upon the vesting of restricted stock units (“RSUs”) valued at $96,524 to Company executives and employees, non-employee directors, and former Company executives (Mr. Varner and Ms. Vaczy) pursuant to the terms of employment and/or separation agreements, (iv) 1,294 shares of common stock due to fractional share rounding adjustments related to the Company’s Reverse Split, (v) 3,300 shares of common stock sold for aggregate net proceeds of approximately $5.9 million associated with the Company’s March 2024 offering, as described above, (vi) 153,701 shares of common stock sold for aggregate net proceeds of approximately $6.1 million under the Company’s 2023 ATM Facility, as described above, and (vii) 27,543 shares of common stock upon the exercise of pre-funded warrants at a nominal price associated with the Company’s March 2024 offering.
F-
12
Preferred Stock
Genprex is authorized to issue 10,000,000 shares of preferred stock at a par value of $0.001 per share, none of which are outstanding at the years ended December 31, 2025 and 2024.
Common Stock
Genprex is authorized to issue 200,000,000 shares of common stock at a par value of $0.001 per share, all of which is voting common stock. There were 3,291,488 and 217,234 shares of common stock outstanding at the years ended December 31, 2025 and 2024, respectively.
Common Stock Purchase Warrants
Common stock purchase warrant activity for the years ended December 31, 2025 and 2024 respectively are as follows:
Number of Weighted Average Number of Weighted Average
Warrants Exercise Price Warrants Exercise Price
Warrants cancelled or expired 25 7,620.00 — —
During the year ended December 31, 2025, and in connection with the registered direct offering, with an institutional investor, completed on October 24, 2025, the Company (i) issued warrants to purchase up to 487,244 shares of common stock, at an exercise price of $11.00 per share, (ii) issued warrants to purchase up to 14,617 shares of common stock to H.C. Wainwright & Co., LLC or its designees (“Placement Agent”), at an exercise price of $14.0125 per share, and in connection with the registered direct offering, with an institutional investor, completed on October 29, 2025, the Company (iii) issued warrants to purchase up to 755,560 shares of common stock, at an exercise price of $8.75 per share, (iv) issued warrants to purchase up to 22,667 shares of common stock to H.C. Wainwright & Co., LLC or its designees (“Placement Agent”), at an exercise price of $11.25 per share, and (v) canceled warrants to purchase up to 25 shares of common stock at a weighted average exercise price of $7,620.00. The Company did not record any share-based compensation related to warrants during the year ended December 31, 2025. The Company expects to record approximately $0.3 million of share-based compensation based on performance-based vesting in the future with respect to its warrants outstanding as of December 31, 2025.
During the year ended December 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 27,543 shares of common stock at a nominal exercise price of $0.01 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 30,843 shares of common stock, at an exercise price of $204.50 per share, (iii) issued warrants to purchase up to 1,852 shares of common stock to H.C. Wainwright & Co., LLC or its designees (“Placement Agent”), at an exercise price of $263.44 per share, (iv) amended existing warrants to purchase up to an aggregate of 3,885 shares of common stock that were previously issued to the same institutional investor in March 2023 and July 2023, such that the amended warrants have a reduced exercise price of $4.09 per share and an expiration date of five years from the closing of the March 2024 offering, and (v) issued 27,543 shares of common stock associated with the exercise of March 2024 Pre-Funded Warrants. During the year ended December 31, 2024, the Company recorded share-based compensation of $18,039 associated with the vesting and issuance of warrants.
As of December 31, 2025, Genprex had outstanding warrants to purchase 1,319,696 shares of common stock at a weighted average exercise price of $ 24.40 that have been issued to various consultants, investors, and placement agents of the Company. These warrants vest immediately or over periods ranging up to 12 months, are exercisable for a period of up to five years, enable the holders to purchase shares of the Company’s common stock at exercise prices ranging from $8.75 to $14,440.00 per share and have per-share fair values ranging from $60.67 to $9,250.20, 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 the years ended December 31, 2025 and 2024, respectively.
Expected term (in years): 1.0 5.0
Dividend yield: 0 % 0 %
Warrant Modifications
On March 21, 2024, the Company amended two warrants whereby, for both warrants, the exercise price was reduced to $204.50 per share and the maturity dates were extended to a term of five years. The value of these modifications were calculated using the Black-Scholes-Merton option pricing model based on the following weighted average assumptions:
Post-modification Pre-modification
Expected term (in years): 5.0 4.00 - 4.50
Dividend yield: 0 % 0 %
The incremental fair value attributable to the modified awards compared to the original awards immediately prior to the modification was calculated at $277,119, which was treated as a deemed dividend and is reflected as “Deemed dividend related to warrant modification” in the accompanying statement of operations.
F-
13
2018 Equity Incentive Plan
The Company’s board of directors and stockholders have approved and adopted the Genprex 2018 Equity Incentive Plan (“2018 Plan”), which became effective on the completion of the Company’s IPO on April 3, 2018. The 2018 Plan provides for the grant of incentive stock options that are intended to qualify under Section 422 of the Internal Revenue Code of 1986, as amended (“ISOs”), nonstatutory stock options, stock appreciation rights, restricted stock awards, RSU awards, performance-based stock awards and performance-based cash awards. ISOs may be granted only to employees. All other awards may be granted to employees, including officers, and to the Company’s non-employee directors and consultants.
A total of 2,080 shares of common stock were initially available under the 2018 Plan, plus a number of shares of common stock (not to exceed 1,314 shares) subject to outstanding awards under the Company’s 2009 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 the 2009 Plan.
In addition, the number of shares of common stock reserved for issuance under the 2018 Plan automatically increases on January 1 of each year, since January 1, 2019, by 5% of the total number of shares of the Company’s common stock outstanding on December 31 of the preceding calendar year, or a lesser number of shares determined by the Company’s board of directors or a committee of the board of directors appointed to administer the 2018 Plan.
On August 15, 2025 at the 2025 Annual Meeting of Stockholders, the Company’s stockholders approved the Company’s amended and restated 2018 Plan (the “2018 Amended Plan”). The principal changes to the 2018 Plan implemented by the 2018 Amended Plan include amendments to (i) increase the number of shares of the Company’s common stock authorized for issuance under the 2018 Plan by an additional 130,000 shares (subject to adjustment for stock splits, stock dividends and similar events), (ii) extend the term of the 2018 Plan to June 30, 2035 (the 10-year anniversary of the Board’s adoption of the Amended Equity Plan) and (iii) remove provisions of the 2018 Plan that had been included to comply with the exception for the deductibility of “performance-based compensation” under Section 162(m) of the Internal Revenue Code of 1986, as amended, which was repealed by the Tax Cuts and Jobs Act of 2017. The 2018 Amended Plan became effective upon its approval by the Company’s stockholders at the 2025 Annual Meeting.
On January 1, 2024 and 2025, the number of shares of common stock reserved for issuance under the 2018 Plan was increased by an aggregate of 1,486 and 10,861 shares, respectively. As of December 31, 2025, a total of 1,558 shares of common stock remained available for issuance for future awards under the 2018 Plan. Subsequent to the year ended December 31, 2025, an additional 164,574 shares of common stock became available for issuance for future awards under the 2018 Plan pursuant to the evergreen provision thereof.
2018 Employee Stock Purchase Plan
The Company’s board of directors and stockholders approved and adopted the Genprex 2018 Employee Stock Purchase Plan (“ESPP”), which became effective on April 3, 2018. The ESPP has not yet been utilized as a benefit available to the Company’s employees. The ESPP authorizes the issuance of 105 shares of common stock pursuant to purchase rights that may be granted to eligible employees. The number of shares of common stock reserved for issuance under the ESPP is automatically increased on January 1 of each calendar year, beginning on January 1, 2019, by 2% of the total number of shares of common stock outstanding on December 31 of the preceding calendar year, or a lesser number of shares determined by the administrator of the ESPP. In January 2025, the administrator of the ESPP determined not to increase the number of shares reserved for issuance under the ESPP for the 2025 fiscal year.
F-
14
Stock Options
As of December 31, 2025, Genprex had outstanding stock options to purchase 5,705 shares of common stock that have been granted to various executives, other employees, directors, and independent contractors of the Company, including outstanding stock options to purchase 509 shares of common stock issued as inducement grants, outside of the 2018 Plan, associated with the hiring of new executives in 2021 and 2023. These options vest immediately or over periods ranging from 12 to 48 months, are exercisable for a period of up to ten years, and enable the holders to purchase shares of the Company’s common stock at exercise prices ranging from $900.00 to $19,600.00 per share.
The Company did not issue stock options during the year ended December 31, 2025. During the year ended December 31, 2025, the Company cancelled stock options to purchase 1 share of common stock with an exercise price of $4,280.00 per share in connection with the termination of employees.
The Company did not issue stock options during the year ended December 31, 2024. During the year ended December 31, 2024, the Company cancelled stock options to purchase 44 shares of common stock with a weighted average exercise price of $2,515.00 in connection with the termination of employees.
The weighted average remaining contractual term for the outstanding options at December 31, 2025 and 2024 is 4.11 and 5.11 years, respectively.
Stock option activity for the years ended December 31, 2025 and 2024, respectively, is as follows:
Number of Weighted Average Number of Weighted Average
Options Exercise Price Options Exercise Price
Options granted — — — —
Options exercised — — — —
F-
15
Restricted Stock Units
During the year ended December 31, 2025, the Company (i) issued 141,600 RSUs to executives, other employees, and non-employee directors, (ii) cancelled 246 RSUs associated with the termination of employees, (iii) withheld 328 RSUs to cover taxes associated with the vesting of employee issued RSUs, and (iv) issued 1,790 shares of common stock associated with the vesting of RSUs to executives, other employees, and non-employee directors.
During the year ended December 31, 2024, the Company (i) issued 1,922RSUs to executives, other employees, and non-employee directors, (ii) cancelled 9RSUs associated with the termination of employees, (iii) withheld 202RSUs to cover taxes associated with the vesting of employee issued RSUs, and (iv) issued 636shares of common stock associated with the vesting of RSUs to executives, other employees, and non-employee directors.
A summary of the RSU activity under the 2018 Plan during the years ended December 31, 2025 and 2024, respectively, is presented below. These amounts include RSUs granted to executives, other employees, and board members.
Number of Weighted Average Number of Weighted Average
Units Grant Date Fair Value Units Grant Date Fair Value
Share-Based Compensation
In the year ended December 31, 2025, Genprex’s total share-based compensation was approximately $0.30 million, consisting of $0.20 million and $0.10 million associated with G&A expense and R&D expense, respectively, which represents the vesting of options and warrants issued to service providers, executives, other employees, and board members of the Company. As of December 31, 2025, the Company’s total compensation cost related to non-vested time-based stock option awards, RSUs, and warrants granted to executives, other employees, board members, and service providers and not yet recognized was approximately $0.32 million, consisting of $0.21 million and $0.12 million associated with G&A expense and R&D expense, respectively. Genprex expects to record this stock-based compensation expense over the next three years using a graded vesting method. As of December 31, 2025, the weighted average term over which these expenses are expected to be recognized is 1.06 years.
As of December 31, 2025, there are no performance-based stock option awards outstanding and one performance-based warrant outstanding issued to a service provider of the Company. Genprex’s total compensation cost related to the non-vested performance-based warrant not yet recognized was approximately $300,000. The entirety of this warrant may be recognized and recorded upon the achievement of certain milestones.
In the year ended December 31, 2024, the Company’s total share-based compensation was approximately $3.30 million, consisting of $2.80 million and $0.60 million associated with G&A expense and R&D expense, respectively, which represents the vesting of options and warrants issued to service providers, executives, other employees, and board members of the Company.
Note 5 - 401(k) Savings Plan Transactions
In 2022, Genprex established a defined-contribution savings plan under Section 401(k) of the Internal Revenue Code (“401(k) Plan”) and established an employer matching program for participants in the 401(k) Plan. The 401(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. Genprex incurred $90,901 and $125,731 of expense for matching contributions to the 401(k) Plan for the years ended December 31, 2025 and 2024, respectively.
Note 6 - 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 in 2011 to include additional sublicensing of additional intellectual property made available to IRI from MD Anderson (see “Note 7 – Commitments and Contingences – Commitments – MD Anderson”). There were no amounts incurred or due under this agreement at the years ended December 31, 2025 and 2024.
F-
16
Note 7 - Commitments and Contingencies
Commitments
MD Anderson
In July 2018, Genprex entered into a two-year sponsored research agreement with MD Anderson to sponsor preclinical studies focused on the combination of REQORSA with an immunotherapy with a projected total cost of approximately $2 million. This agreement was extended beyond the original expiration date, expiring in May 2022 after giving effect to such extension. In August 2022, the Company entered into a three-year sponsored research agreement with MD Anderson ( “August 2022 SRA”) to sponsor preclinical studies focused on REQORSA and NPRL2 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 2022 SRA with MD Anderson to (i) extend the sponsored research program an additional six 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 $2.75 million. The Company incurred approximately $828,505 and $811,540 of expense from this agreement during the years ended December 31, 2025 and 2024, respectively. As of December 31, 2025, the Company has paid approximately $2.43 million toward this $2.77 million commitment.
In 2011, the Company agreed to assume certain contractual and other obligations of IRI in consideration for the sublicense rights, expertise, and assistance associated with certain technologies and intellectual property originally licensed to another party under the 1994 License Agreement with MD Anderson (“Original MD Anderson License Agreement”). These technologies and intellectual property were later sublicensed to IRI (the “IRI Sublicense”). The Company also agreed to pay royalties of 1% on sales of certain licensed products for a period of 21 years following the termination of the later of the Original MD Anderson License Agreement and the IRI Sublicense. The Company assumed patent prosecution costs and an annual minimum royalty of $20,000 payable to the National Institutes of Health.
On March 3, 2021, the Company entered into an amendment (the “MD License Amendment”) to the Patent and Technology License Agreement dated May 4, 2020, with MD Anderson. The MD License Amendment grants Genprex a worldwide, exclusive, sublicensable license to an additional portfolio of six patents and one patent application and related technology for methods for treating cancer by administration of a TUSC2 therapy in conjunction with EGFR inhibitors or other anti-cancer therapies in patients predicted to be responsive to TUSC2 therapy. Pursuant to the MD License Amendment, the Company agreed to (i) pay annual maintenance fees ranging from the mid five figures to the low six figures, (ii) total milestone payments of $6,150,000, (iii) a one-time fee in the mid five figures and (iv) certain patent-related expenses. The Company incurred approximately $155,000 and $50,000 of expense from this agreement during the years ended December 31, 2025 and 2024, respectively. As of December 31, 2025, Genprex has paid approximately $525,000 toward this commitment.
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 $400,000 and $380,000 for the years ended December 31, 2025 and 2024, respectively, will be recognized when the Company obtains regulatory approval (the event that triggers the payment obligation).
New York University
On April 25, 2025, the Company and NYU entered into the NYU License Agreement, which granted Genprex exclusive patent and commercial rights worldwide relating to Genprex’s lead drug candidate REQORSA for the potential treatment of mesothelioma. Pursuant to the NYU License Agreement, Genprex agreed to pay: (i) an initial license fee of $5,000, (ii) annual license fees of $35,000 for the first and second year anniversaries, $25,000 for the third anniversary and $50,000 for the fourth year and each subsequent year following the fourth anniversary of the agreement thereafter, (iii) running low single digit percentage royalties ranging from 1% to 2% of net sales, (iv) certain potential technical milestone payments through regulatory approval up to an aggregate of approximately $400,000, and (v) certain patent-related expenses. The Company incurred approximately $5,000of expense from this agreement during the year ended December 31, 2025. As of December 31, 2025, Genprex has paid approximately $5,000 toward this commitment.
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 for 2025 and 2026, and $30,000 for 2027 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. The Company incurred approximately $15,000 and $15,000 of expense from this agreement during the years ended December 31, 2025 and 2024, respectively. As of December 31, 2025, Genprex has paid approximately $30,000 toward this commitment.
F-
17
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 and third years, and $120,000 for the fourth year and each subsequent year following the fourth anniversary of the agreement thereafter until the anniversary prior to the year of the first 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 the first 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 Type 1 and Type 2 diabetes. Unless earlier terminated pursuant to its terms, the agreement expires upon the later of (i) 20 years after the first commercial sale of the licensed technology thereunder and (ii) expiration of the last valid claim under the patent rights. In connection with the New UP License Agreement, the Company incurred $15,000 and $0 of expense from this agreement for the years ended December 31, 2025 and 2024, respectively. As of December 31, 2025, Genprex has paid approximately $15,000 toward this commitment.
UTHealth Houston
On May 2, 2025, the Company and UTHealth Houston entered into the UTH License Agreement, which granted Genprex exclusive patent and commercial rights worldwide relating to Genprex’s lead drug candidate REQORSA for the potential treatment of glioblastoma. Pursuant to the UTH License Agreement, Genprex agreed to pay (i) an initial license issue fee of $10,000 along with additional, staggered upfront license fees totaling another $40,000 and an annual license management fee of $3,000, (ii) running low single digit percentage royalties ranging from 0.10% to 0.25% of net product sales, (iii) minimum annual royalty of $25,000 beginning after the first year in which royalties obligations commence pursuant to the UTH License Agreement, (iv) certain potential clinical and regulatory milestone payments through FDA and international regulatory approvals up to an aggregate of approximately $360,000, and (v) certain patent-related expenses. The Company incurred approximately $10,000of expense from this agreement during the year ended December 31, 2025. As of December 31, 2025, Genprex has paid approximately $10,000 toward this commitment.
Contract Development and Manufacturing Organization
Genprex entered into a three-year development services agreement in July 2022, amended in each of January 2023 and 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 returned $1.3 million to the Company and no additional commitments are obligated or owed by the Company. The Company incurred no expense from this agreement during either of the years ended December 31, 2025 and 2024.
Contingencies
From time to time, the Company may become subject to threatened and/or asserted claims arising in the ordinary course of its business. The Company is not aware of any matters, either individually or in the aggregate, that are reasonably likely to have a material impact on its financial condition, results of operations or liquidity.
F-
18
Note 8 – 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 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 Note 2, 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:
Year Ended
December 31,
Revenues $ — $ —