Core Viewpoint - Genprex, Inc. has received patent allowances for its lead drug candidate, Reqorsa® Gene Therapy, in combination with immune checkpoint inhibitors, enhancing its intellectual property portfolio for oncology treatments [1][2][3] Intellectual Property Developments - The U.S. Patent and Trademark Office and the European Patent Office have issued Notices of Allowance for patents covering the use of Reqorsa in combination with PD-L1 and PD-1 antibodies, respectively, with both patents set to expire in 2037 at the earliest [1][3] - Genprex has also secured patents for Reqorsa in combination with PD-L1 antibodies in Korea and is pursuing additional patent applications in Europe, Canada, Brazil, China, and Israel [3] Clinical Trial Information - The Acclaim-3 study is a Phase 1/2 clinical trial evaluating Reqorsa in combination with Genentech's Tecentriq® for patients with extensive stage small cell lung cancer (ES-SCLC) [5] - The Acclaim-3 trial has received FDA Fast Track Designation and Orphan Drug Designation, indicating its potential significance in treating this patient population [5] Company Overview - Genprex, Inc. is a clinical-stage gene therapy company focused on developing therapies for cancer and diabetes, utilizing a non-viral Oncoprex® Delivery System for its gene therapies [6] - The company's lead product candidate, Reqorsa, is being evaluated in clinical trials for non-small cell lung cancer (NSCLC) and small cell lung cancer (SCLC), both of which have received FDA Fast Track Designation [6]

[PART I - FINANCIAL INFORMATION](index=4&type=section&id=PART%20I%20FINANCIAL%20INFORMATION) This section covers Genprex's unaudited consolidated financial statements and management's analysis of financial condition and operations [ITEM 1. FINANCIAL STATEMENTS](index=4&type=section&id=ITEM%201.%20FINANCIAL%20STATEMENTS) This section presents Genprex, Inc.'s unaudited consolidated condensed financial statements, including balance sheets, statements of operations, equity, cash flows, and detailed notes for periods ended June 30, 2025, and December 31, 2024 [Consolidated Condensed Balance Sheets](index=4&type=section&id=Consolidated%20Condensed%20Balance%20Sheets) The company's financial position as of June 30, 2025, shows a decrease in cash, total assets, and stockholders' equity compared to December 31, 2024, while the accumulated deficit grew | Metric | June 30, 2025 | December 31, 2024 | Change | % Change | |:---|:---|:---|:---|:---| | Cash and cash equivalents | $1,346,844 | $1,601,660 | $(254,816) | -15.91% | | Total current assets | $2,056,184 | $2,077,467 | $(21,283) | -1.02% | | Total assets | $3,827,524 | $4,124,325 | $(296,801) | -7.20% | | Total current liabilities | $2,436,329 | $2,504,170 | $(67,841) | -2.71% | | Total stockholders' equity | $1,391,195 | $1,620,155 | $(228,960) | -14.13% | | Accumulated deficit | $(163,438,946) | $(154,799,443) | $(8,639,503) | 5.58% (increase in deficit) | [Consolidated Condensed Statements of Operations](index=5&type=section&id=Consolidated%20Condensed%20Statements%20of%20Operations) Genprex reported a reduced net loss for both the three and six months ended June 30, 2025, compared to 2024, driven by significant decreases in general and administrative expenses, despite increased research and development costs for the three-month period Three Months Ended June 30 | Metric | 2025 | 2024 | Change | % Change | |:---|:---|:---|:---|:---| | Research and development | $2,499,495 | $1,666,522 | $832,973 | 50.0% | | General and administrative | $2,182,289 | $4,849,472 | $(2,667,183) | -55.0% | | Total operating expenses | $4,681,784 | $6,518,282 | $(1,836,498) | -28.2% | | Net loss | $(4,674,901) | $(6,495,845) | $1,820,944 | -28.0% | | Net loss per share (basic & diluted) | $(0.17) | $(3.00) | $2.83 | -94.3% | | Weighted average common shares | 27,593,952 | 2,161,961 | 25,431,991 | 1176.3% | Six Months Ended June 30 | Metric | 2025 | 2024 | Change | % Change | |:---|:---|:---|:---|:---| | Research and development | $5,039,489 | $4,940,902 | $98,587 | 2.0% | | General and administrative | $3,611,587 | $7,569,140 | $(3,957,553) | -52.3% | | Total operating expenses | $8,651,076 | $12,515,000 | $(3,863,924) | -30.9% | | Net loss | $(8,639,503) | $(12,464,714) | $3,825,211 | -30.7% | | Net loss per share (basic & diluted) | $(0.40) | $(6.59) | $6.19 | -93.9% | | Weighted average common shares | 21,463,658 | 1,891,773 | 19,571,885 | 1034.6% | [Consolidated Condensed Statements of Changes in Stockholders' Equity](index=6&type=section&id=Consolidated%20Condensed%20Statements%20of%20Changes%20in%20Stockholders'%20Equity) Stockholders' equity decreased from $1,620,155 at December 31, 2024, to $1,391,195 at June 30, 2025, primarily due to a net loss, partially offset by common stock issuances and share-based compensation - Total stockholders' equity decreased by **$228,960** from **$1,620,155** at December 31, 2024, to **$1,391,195** at June 30, 2025[18](index=18&type=chunk) - Net loss for the six months ended June 30, 2025, was **$(8,639,503)**, contributing to the accumulated deficit[18](index=18&type=chunk) - Issuance of common stock, pre-funded warrants, and warrants for cash, net of issuance costs, provided **$7,770,844** in the six months ended June 30, 2025[18](index=18&type=chunk)[22](index=22&type=chunk) [Consolidated Condensed Statements of Cash Flows](index=7&type=section&id=Consolidated%20Condensed%20Statements%20of%20Cash%20Flows) Net cash used in operating activities significantly decreased by 32% for the six months ended June 30, 2025, compared to 2024, primarily due to clinical trial closure and expense reduction, with increased cash from financing leading to a smaller net decrease in cash | Metric | Six Months Ended June 30, 2025 | Six Months Ended June 30, 2024 | Change | % Change | |:---|:---|:---|:---|:---| | Net cash used in operating activities | $(8,025,660) | $(11,867,211) | $3,841,551 | -32.4% | | Net cash provided by investing activities | $0 | $774,645 | $(774,645) | -100.0% | | Net cash provided by financing activities | $7,770,844 | $6,813,961 | $956,883 | 14.0% | | Net decrease in cash and cash equivalents | $(254,816) | $(4,278,605) | $4,023,789 | -94.0% | | Cash and cash equivalents, end of period | $1,346,844 | $2,459,024 | $(1,112,180) | -45.2% | [Notes to Unaudited Consolidated Condensed Financial Statements](index=8&type=section&id=Notes%20to%20Unaudited%20Consolidated%20Condensed%20Financial%20Statements) These notes provide critical context to the financial statements, detailing business operations, accounting policies, intellectual property, equity, commitments, and segment reporting, with updates on clinical trials, a new subsidiary, and ongoing capital efforts amidst liquidity concerns [Note 1 - Description of Business and Basis of Presentation](index=8&type=section&id=Note%201%20-%20Description%20of%20Business%20and%20Basis%20of%20Presentation) Genprex is a clinical-stage gene therapy company focused on oncology and diabetes, advancing REQORSA® in NSCLC and SCLC trials and GPX-002 for diabetes, but faces significant capital requirements and liquidity challenges, raising substantial doubt about its going concern ability beyond August 2025 - Genprex is a clinical stage gene therapy company developing gene-based therapies for oncology (**REQORSA® gene therapy**) and diabetes (**GPX-002**)[24](index=24&type=chunk)[25](index=25&type=chunk)[35](index=35&type=chunk) - REQORSA is in Phase 2a expansion for Acclaim-1 (NSCLC with Tagrisso) and Phase 2 expansion for Acclaim-3 (ES-SCLC with Tecentriq), both having received FDA Fast Track Designation. Acclaim-2 (NSCLC with Keytruda) enrollment ceased due to challenges[27](index=27&type=chunk)[29](index=29&type=chunk)[32](index=32&type=chunk)[33](index=33&type=chunk)[34](index=34&type=chunk) - GPX-002 for Type 1 and Type 2 diabetes is in preclinical studies, with plans to seek FDA guidance on IND-enabling studies in H2 2025. A new subsidiary, Convergen Biotech, Inc., was formed to focus the diabetes program[35](index=35&type=chunk)[37](index=37&type=chunk) - The company has sustained substantial losses and expects current cash to fund operations only through August 2025, raising substantial doubt about its ability to continue as a going concern without additional capital[38](index=38&type=chunk)[39](index=39&type=chunk)[40](index=40&type=chunk)[41](index=41&type=chunk) [Note 2 - Summary of Significant Accounting Policies](index=12&type=section&id=Note%202%20-%20Summary%20of%20Significant%20Accounting%20Policies) This note outlines the company's accounting practices, including unaudited consolidated condensed financial statements in accordance with US GAAP, a voluntary change to expense intellectual property costs, a retroactive adjustment for a 1-for-40 reverse stock split, and the treatment of cash equivalents, net loss per share, and stock-based compensation - Financial statements are prepared in accordance with US GAAP for interim reporting, consolidating Genprex and its wholly-owned subsidiary, Convergen Biotech, Inc.[43](index=43&type=chunk)[46](index=46&type=chunk) - The company voluntarily changed its accounting principle to expense, rather than capitalize, intellectual property costs, effective for the year ended December 31, 2024[47](index=47&type=chunk) - A **1-for-40 reverse stock split** was completed on February 2, 2024, with all per-share information retroactively adjusted[48](index=48&type=chunk) - The company manages its operations as a single segment and recognizes stock-based compensation at fair value over the vesting period[53](index=53&type=chunk)[61](index=61&type=chunk) [Note 3 - Intellectual Property](index=16&type=section&id=Note%203%20-%20Intellectual%20Property) Genprex holds exclusive licenses for 12 granted patents and 25 pending patent applications globally, covering oncology and diabetes technologies, with recent agreements including an amended license with the University of Pittsburgh for diabetes gene therapy and new licenses for REQORSA applications in lung cancer, mesothelioma, and glioblastoma - Genprex owns or has exclusive licenses for **12 granted patents** and **25 pending patent applications** worldwide[69](index=69&type=chunk) - An amended and restated Exclusive License Agreement with the University of Pittsburgh was signed on February 17, 2025, for Type 1 and Type 2 diabetes gene therapy[70](index=70&type=chunk) - New exclusive license agreements were entered into with the University of Michigan (**REQORSA** with ALK-inhibitors for lung cancer), NYU (**REQORSA** for mesothelioma), and UTHealth Houston (**REQORSA** for glioblastoma) in late 2024 and early 2025[72](index=72&type=chunk)[73](index=73&type=chunk)[74](index=74&type=chunk) [Note 4 - Equity](index=17&type=section&id=Note%204%20-%20Equity) This note details Genprex's equity activities, including a 1-for-40 reverse stock split in February 2024, capital raised through a registered direct offering and an At-The-Market (ATM) facility, a new Equity Line of Credit (ELOC) in June 2025, significantly increased common stock outstanding, and various stock-based compensation plans - A **1-for-40 reverse stock split** was completed on February 2, 2024, retroactively adjusting all per-share information[75](index=75&type=chunk) - In the six months ended June 30, 2025, the company sold **16,940,454 shares** for **$6,895,947** net proceeds via its 2023 ATM Facility and **5,244,709 shares** for **$874,897** net proceeds via its 2025 ELOC Facility[77](index=77&type=chunk)[82](index=82&type=chunk) - As of June 30, 2025, **33,145,048 shares** of common stock were outstanding, up from **10,860,655** at December 31, 2024[86](index=86&type=chunk) - Total share-based compensation for the six months ended June 30, 2025, was approximately **$0.6 million**, including **$0.1 million** in R&D and **$0.5 million** in G&A expense[105](index=105&type=chunk) [Note 5 - 401(k) Savings Plan](index=24&type=section&id=Note%205%20-%20401(k)%20Savings%20Plan) Genprex maintains a 401(k) savings plan with an employer matching program, with matching contributions expense decreasing to $53,332 for the six months ended June 30, 2025, from $73,919 in the prior year period 401(k) Matching Contributions Expense | Period | 2025 | 2024 | |:---|:---|:---| | Three Months Ended June 30 | $26,944 | $36,529 | | Six Months Ended June 30 | $53,332 | $73,919 | [Note 6 - Related Party Transactions](index=24&type=section&id=Note%206%20-%20Related%20Party%20Transactions) The company has an Assignment and Collaboration Agreement with Introgen Research Institute (IRI), a related party, providing exclusive commercialization rights to intellectual property, with no amounts incurred or due under this agreement as of June 30, 2025, or December 31, 2024 - Genprex has an Assignment and Collaboration Agreement with Introgen Research Institute (IRI), a company formed by the former CEO, for exclusive commercialization rights to intellectual property[109](index=109&type=chunk) - No amounts were incurred or due under this agreement as of June 30, 2025, and December 31, 2024[109](index=109&type=chunk) [Note 7 - Commitments and Contingencies](index=25&type=section&id=Note%207%20-%20Commitments%20and%20Contingencies) Genprex has various commitments, including sponsored research agreements with MD Anderson, annual maintenance fees, and potential milestone payments for intellectual property licenses from multiple universities, along with a contingent royalty obligation to NIH upon FDA approval, and a terminated development services agreement with a CDMO - Commitments include a sponsored research agreement with MD Anderson (August 2022 SRA) with a total commitment of approximately **$2.76 million**, of which **$2.1 million** has been paid as of June 30, 2025[110](index=110&type=chunk) - The company has various license agreements with MD Anderson, NYU, University of Michigan, University of Pittsburgh, and UTHealth Houston, involving initial fees, annual maintenance fees, running royalties, and potential milestone payments totaling several millions[112](index=112&type=chunk)[114](index=114&type=chunk)[115](index=115&type=chunk)[117](index=117&type=chunk)[118](index=118&type=chunk) - A contingent royalty obligation to NIH of **$400,000** (as of June 30, 2025) will be recognized upon probable FDA regulatory approval[113](index=113&type=chunk) - A three-year development services agreement with a CDMO was terminated by mutual agreement on June 30, 2024, with **$1.3 million** returned to the company[119](index=119&type=chunk) [Note 8 - Segment Reporting](index=28&type=section&id=Note%208%20-%20Segment%20Reporting) Genprex operates as a single segment focused on gene therapies, with the CEO assessing performance and allocating resources based on the consolidated net loss, which decreased to $8,639,503 for the six months ended June 30, 2025, from $12,464,715 in the prior year, with significant expenses in clinical, manufacturing, research, and general and administrative support - The company manages its operations as a single segment focused on the discovery and development of gene therapies[121](index=121&type=chunk) Segment and Net Loss | Expense Category | Three Months Ended June 30, 2025 | Three Months Ended June 30, 2024 | Six Months Ended June 30, 2025 | Six Months Ended June 30, 2024 | |:---|:---|:---|:---|:---| | Clinical and regulatory | $1,659,513 | $1,971,538 | $3,366,218 | $4,105,576 | | Manufacturing | $472,598 | $(252,279) | $955,663 | $519,839 | | Research | $328,991 | $(243,915) | $637,317 | $(3,845) | | General and administrative support | $1,761,765 | $2,968,623 | $3,048,188 | $5,273,733 | | Non-cash expenses | $458,917 | $2,074,315 | $643,690 | $2,619,698 | | Segment and net loss | $4,674,901 | $6,495,845 | $8,639,503 | $12,464,715 | [Note 9 - Subsequent Events](index=28&type=section&id=Note%209%20-%20Subsequent%20Events) Subsequent to June 30, 2025, Genprex issued 5,000 shares of common stock for services and sold 316,736 shares for $70,315 net proceeds under its 2025 ELOC Facility, having utilized the full share capacity under the ELOC's Exchange Cap, requiring stockholder approval for further sales - On July 1, 2025, Genprex issued **5,000 shares** of common stock for services[123](index=123&type=chunk) - From July 1, 2025, through the filing date, **316,736 shares** were sold under the 2025 ELOC Facility for **$70,315** net proceeds[123](index=123&type=chunk) - The company has utilized the full **5,561,455 share capacity** under the Exchange Cap of the 2025 ELOC Facility, requiring stockholder approval for additional sales[123](index=123&type=chunk) [ITEM 2. MANAGEMENT'S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS OF OPERATIONS](index=29&type=section&id=ITEM%202.%20MANAGEMENT'S%20DISCUSSION%20AND%20ANALYSIS%20OF%20FINANCIAL%20CONDITION%20AND%20RESULTS%20OF%20OPERATIONS) This section provides management's perspective on Genprex's financial condition and operational results, highlighting its clinical-stage gene therapy programs in oncology and diabetes, detailing REQORSA trials, strategic focus on diabetes, critical need for additional capital, key accounting estimates, and a comparison of financial performance for the three and six months ended June 30, 2025, versus 2024 [Overview](index=31&type=section&id=Overview) Genprex is a clinical-stage gene therapy company focused on developing treatments for oncology and diabetes, utilizing its ONCOPREX® Delivery System for REQORSA® gene therapy in NSCLC and SCLC, and developing diabetes technology to transform pancreatic alpha cells into insulin-producing beta-like cells for Type 1 diabetes and rejuvenate exhausted beta cells for Type 2 diabetes - Genprex is a clinical stage gene therapy company pioneering gene-based therapies for oncology and diabetes[131](index=131&type=chunk) - The oncology platform utilizes the systemic, non-viral **ONCOPREX® Delivery System** to deliver tumor suppressor gene-expressing plasmids to cancer cells, with **REQORSA® gene therapy** as the lead candidate for NSCLC and SCLC[131](index=131&type=chunk)[132](index=132&type=chunk) - The diabetes technology aims to transform alpha cells into functional beta-like cells for Type 1 diabetes and replenish/rejuvenate exhausted beta cells for Type 2 diabetes[131](index=131&type=chunk) [Oncology Platform](index=31&type=section&id=Oncology%20Platform) Genprex's lead oncology candidate, REQORSA gene therapy, is being developed for NSCLC and SCLC, with the Acclaim-1 trial (REQORSA + Tagrisso for NSCLC) in Phase 2a expansion with interim analysis expected in H1 2026 and FDA Fast Track Designation, the Acclaim-2 trial (REQORSA + Keytruda for NSCLC) closed due to enrollment challenges, and the Acclaim-3 trial (REQORSA + Tecentriq for ES-SCLC) in Phase 2 expansion with interim analysis for the first 25 patients expected in Q1 2026 and both FDA Fast Track and Orphan Drug Designations - **REQORSA gene therapy** is the lead oncology drug candidate, developed in combination with approved cancer drugs for NSCLC and SCLC[132](index=132&type=chunk) - **Acclaim-1 trial** (**REQORSA** + Tagrisso for NSCLC) is in Phase 2a expansion, with enrollment of the first 19 patients for interim analysis expected by Q1 2026 and interim analysis in H1 2026. It has FDA Fast Track Designation[134](index=134&type=chunk)[135](index=135&type=chunk) - **Acclaim-2 trial** (**REQORSA** + Keytruda for NSCLC) was ceased for new patient enrollment in August 2024 due to enrollment challenges and resource prioritization[137](index=137&type=chunk) - **Acclaim-3 trial** (**REQORSA** + Tecentriq for ES-SCLC) is in Phase 2 expansion, with enrollment of the first 25 patients for interim analysis expected in Q1 2026. It has FDA Fast Track and Orphan Drug Designations[138](index=138&type=chunk)[139](index=139&type=chunk) [Diabetes Gene Therapy](index=33&type=section&id=Diabetes%20Gene%20Therapy) Genprex's diabetes gene therapy, GPX-002, exclusively licensed from the University of Pittsburgh, is in preclinical development for Type 1 and Type 2 diabetes, aiming to transform pancreatic alpha cells into functional beta-like cells or rejuvenate exhausted beta cells, with plans to seek further FDA guidance on IND-enabling studies in the second half of 2025 - Genprex has exclusively licensed multiple technologies from the University of Pittsburgh for a gene therapy product (**GPX-002**) for Type 1 and Type 2 diabetes[140](index=140&type=chunk) - **GPX-002** for Type 1 diabetes aims to transform alpha cells into functional beta-like cells, while for Type 2 diabetes, it aims to replenish and rejuvenate exhausted beta cells[140](index=140&type=chunk) - The company plans to seek further FDA guidance on IND-enabling studies in the second half of 2025, following additional nonclinical studies and a new sponsored research agreement with the University of Pittsburgh[140](index=140&type=chunk) [Recently Issued Accounting Pronouncements](index=35&type=section&id=Recently%20Issued%20Accounting%20Pronouncements) The company is evaluating ASU 2023-09, 'Income Taxes (Topic 740): Improvements to Income Tax Disclosures,' effective for annual periods beginning after December 15, 2024, which requires disaggregated information about effective tax rate reconciliation and income taxes paid - The company is evaluating **ASU 2023-09**, 'Income Taxes (Topic 740): Improvements to Income Tax Disclosures,' which is effective for annual periods beginning after December 15, 2024[67](index=67&type=chunk)[142](index=142&type=chunk) - This standard requires disaggregated information about a reporting entity's effective tax rate reconciliation and information on income taxes paid[67](index=67&type=chunk) [Critical Accounting Estimates](index=35&type=section&id=Critical%20Accounting%20Estimates) Genprex's critical accounting estimates involve significant judgments and assumptions, particularly for research and development costs, income taxes, impairment of long-lived assets, and modification of equity classified warrants, impacting reported asset and liability amounts and expense recognition, with actual results potentially differing from estimates - Critical accounting estimates include research and development costs, income taxes, impairment of long-lived assets, and modification of equity classified warrants[144](index=144&type=chunk)[145](index=145&type=chunk)[147](index=147&type=chunk)[148](index=148&type=chunk)[149](index=149&type=chunk) - Estimates for R&D costs are based on services provided by third-party providers, with significant judgments made in determining accrued balances[145](index=145&type=chunk)[146](index=146&type=chunk) - A full valuation allowance is provided on deferred tax assets due to a history of operating losses[147](index=147&type=chunk) [Components of our Results of Operations and Financial Condition](index=37&type=section&id=Components%20of%20our%20Results%20of%20Operations%20and%20Financial%20Condition) Operating expenses are categorized into research and development (R&D), general and administrative (G&A), and depreciation, with R&D expenses expected to increase with advancing clinical trials and expanded research, and G&A expenses also expected to rise with business growth - Operating expenses are classified into research and development, general and administrative, and depreciation[151](index=151&type=chunk) - Research and development expenses are recognized as incurred, with expectations to increase due to advancing clinical trials, manufacturing transitions, regulatory pursuits, and expanded research programs[152](index=152&type=chunk)[153](index=153&type=chunk) - General and administrative expenses are expected to increase in future periods due to anticipated business growth and related infrastructure[154](index=154&type=chunk) [Comparison of the Three and Six Months Ended June 30, 2025 and 2024](index=38&type=section&id=Comparison%20of%20the%20Three%20and%20Six%20Months%20Ended%20June%2030%2C%202025%20and%202024) Genprex experienced a significant decrease in net loss for both the three and six months ended June 30, 2025, compared to 2024, primarily driven by a substantial reduction in general and administrative expenses due to expense reduction strategies and headcount reductions, and the closing of the Acclaim-2 clinical trial, while research and development expenses increased for the three-month period but remained relatively stable for the six-month period Operating Expenses and Net Loss (Three Months Ended June 30) | Metric | 2025 | 2024 | Change | % Change | |:---|:---|:---|:---|:---| | Research and Development | $2,499,495 | $1,666,522 | $832,973 | 50% | | General and Administrative | $2,182,289 | $4,849,472 | $(2,667,183) | -55% | | Net Loss | $(4,674,901) | $(6,495,845) | $1,820,944 | -28% | Operating Expenses and Net Loss (Six Months Ended June 30) | Metric | 2025 | 2024 | Change | % Change | |:---|:---|:---|:---|:---| | Research and Development | $5,039,489 | $4,940,902 | $98,587 | 2% | | General and Administrative | $3,611,587 | $7,569,140 | $(3,957,553) | -52% | | Net Loss | $(8,639,503) | $(12,464,714) | $3,825,211 | -31% | - The decrease in G&A expenses was primarily due to expense reduction strategies, including reduced travel, professional service providers, and headcount (from **8 to 6 G&A staff**)[160](index=160&type=chunk)[161](index=161&type=chunk) - The overall decrease in net loss was also attributed to the closing of the Acclaim-2 clinical trial and associated reductions in clinical and manufacturing expenses, alongside a reduction in total company staff from **21 to 15 employees**[166](index=166&type=chunk)[168](index=168&type=chunk) [Liquidity and Capital Resources](index=39&type=section&id=Liquidity%20and%20Capital%20Resources) Genprex has an accumulated deficit of $163.4 million as of June 30, 2025, and has historically funded operations through equity sales, raising $6.9 million net proceeds from its 2023 ATM Facility and $0.9 million net proceeds from its 2025 ELOC Facility during the six months ended June 30, 2025, with cash and cash equivalents at $1.3 million, and anticipates needing additional capital to fund future operations beyond August 2025, raising substantial doubt about its ability to continue as a going concern - As of June 30, 2025, Genprex had an accumulated deficit of **$163,438,946** and **$1,346,844** in cash and cash equivalents[169](index=169&type=chunk)[174](index=174&type=chunk) - During the six months ended June 30, 2025, the company raised **$6,895,947** net proceeds from its 2023 ATM Facility and **$874,897** net proceeds from its 2025 ELOC Facility[171](index=171&type=chunk) - Net cash used in operating activities decreased by **32%** to **$8,025,660** for the six months ended June 30, 2025, compared to **$11,867,211** in 2024[178](index=178&type=chunk) - The company estimates current cash will fund operations only through August 2025 and will need to raise additional capital, which raises substantial doubt about its ability to continue as a going concern[175](index=175&type=chunk)[176](index=176&type=chunk) [ITEM 3. QUANTITATIVE AND QUALITATIVE DISCLOSURES ABOUT MARKET RISK](index=42&type=section&id=ITEM%203.%20QUANTITATIVE%20AND%20QUALITATIVE%20DISCLOSURES%20ABOUT%20MARKET%20RISK) As a smaller reporting company, Genprex is not required to provide quantitative and qualitative disclosures about market risk - Genprex is exempt from providing quantitative and qualitative disclosures about market risk due to its status as a 'smaller reporting company'[181](index=181&type=chunk) [ITEM 4. CONTROLS AND PROCEDURES](index=42&type=section&id=ITEM%204.%20CONTROLS%20AND%20PROCEDURES) Genprex's management concluded that its disclosure controls and procedures were not effective as of June 30, 2025, due to material weaknesses related to a lack of segregation of duties and insufficient in-house accounting personnel for complex transactions, with remediation plans underway but requiring more time to demonstrate operating effectiveness - Disclosure controls and procedures were not effective as of June 30, 2025, due to material weaknesses[182](index=182&type=chunk) - Material weaknesses include a lack of segregation of duties between accounting and other functions and insufficient depth of in-house accounting personnel for complex transactions[182](index=182&type=chunk)[183](index=183&type=chunk) - Remediation efforts include new accounting software, specific review procedures involving legal and manufacturing staff, a formal Disclosure Committee, additional hiring, and training[185](index=185&type=chunk)[186](index=186&type=chunk) - Remediation efforts require additional time to demonstrate operating effectiveness through testing[187](index=187&type=chunk) [PART II - OTHER INFORMATION](index=44&type=section&id=PART%20II%20OTHER%20INFORMATION) This section covers Genprex's legal proceedings, risk factors, equity sales, defaults, mine safety, other information, and exhibits [ITEM 1. LEGAL PROCEEDINGS](index=44&type=section&id=ITEM%201.%20LEGAL%20PROCEEDINGS) Genprex is not currently involved in any material pending litigation, though legal proceedings can be costly and divert management's attention - Genprex does not currently have any pending litigation deemed material[192](index=192&type=chunk) - Litigation, regardless of outcome, can be costly, time-consuming, and divert management's attention[192](index=192&type=chunk) [ITEM 1A. RISK FACTORS](index=44&type=section&id=ITEM%201A.%20RISK%20FACTORS) This section updates and supplements previously disclosed risk factors, emphasizing the high degree of risk associated with an investment in Genprex, particularly concerning the company's non-compliance with Nasdaq's minimum bid price requirement, which could lead to delisting and negatively impact stock liquidity and capital-raising ability, with the company intending to request a hearing to seek an extension for compliance - An investment in Genprex common stock involves a high degree of risk, with updated and supplemented risk factors[193](index=193&type=chunk) - The company is not in compliance with Nasdaq's **$1.00 minimum bid price requirement** and received a delisting letter on August 12, 2025[194](index=194&type=chunk) - Genprex intends to request a hearing before the Nasdaq Hearings Panel to seek an extension for compliance, potentially considering a reverse stock split[194](index=194&type=chunk)[195](index=195&type=chunk) - Delisting from Nasdaq could materially reduce stock liquidity, negatively impact the stock price, and impair the ability to raise capital[196](index=196&type=chunk) [ITEM 2. UNREGISTERED SALES OF EQUITY SECURITIES AND USE OF PROCEEDS](index=44&type=section&id=ITEM%202.%20UNREGISTERED%20SALES%20OF%20EQUITY%20SECURITIES%20AND%20USE%20OF%20PROCEEDS) During the three months ended June 30, 2025, Genprex issued 5,000 shares of common stock to the Chairman of its Scientific Advisory Board for services, relying on the Section 4(a)(2) exemption from registration under the Securities Act - On April 1, 2025, Genprex issued **5,000 shares** of common stock to the Chairman of its Scientific Advisory Board for services[198](index=198&type=chunk) - These securities were issued in reliance on the exemption from registration under Section 4(a)(2) of the Securities Act[199](index=199&type=chunk) [ITEM 3. DEFAULTS UPON SENIOR SECURITIES](index=45&type=section&id=ITEM%203.%20DEFAULTS%20UPON%20SENIOR%20SECURITIES) There were no defaults upon senior securities during the reporting period - No defaults upon senior securities occurred[200](index=200&type=chunk) [ITEM 4. MINE SAFETY DISCLOSURES](index=45&type=section&id=ITEM%204.%20MINE%20SAFETY%20DISCLOSURES) This item is not applicable to Genprex - Mine Safety Disclosures are not applicable to the company[201](index=201&type=chunk) [ITEM 5. OTHER INFORMATION](index=45&type=section&id=ITEM%205.%20OTHER%20INFORMATION) Genprex received a delisting letter from Nasdaq on August 12, 2025, for failing to meet the $1.00 minimum bid price requirement and being ineligible for a further extension, with the company intending to request a hearing to seek continued listing and potentially considering a reverse stock split, and no officers or directors adopted or terminated Rule 10b5-1 trading arrangements during the quarter - Genprex received a delisting letter from Nasdaq on August 12, 2025, for non-compliance with the **$1.00 minimum bid price requirement** and ineligibility for a second 180-day compliance period[202](index=202&type=chunk) - The company intends to request a hearing before the Nasdaq Hearings Panel to seek an extension for compliance, potentially including a reverse stock split[203](index=203&type=chunk) - No officers or directors adopted or terminated Rule 10b5-1 or non-Rule 10b5-1 trading arrangements during the fiscal quarter ended June 30, 2025[205](index=205&type=chunk) [ITEM 6. EXHIBITS](index=45&type=section&id=ITEM%206.%20EXHIBITS) This section lists all exhibits filed with the Form 10-Q, including organizational documents, material contracts like the Purchase Agreement with Lincoln Park Capital Fund, LLC, and certifications required by the Sarbanes-Oxley Act - Exhibits include Amended and Restated Certificate of Incorporation, Bylaws, and amendments[208](index=208&type=chunk) - Material contracts such as the Purchase Agreement and Registration Rights Agreement with Lincoln Park Capital Fund, LLC, dated June 11, 2025, are included[208](index=208&type=chunk) - Certifications of the Chief Executive Officer and Chief Financial Officer pursuant to the Securities Exchange Act of 1934 and the Sarbanes-Oxley Act of 2002 are filed[208](index=208&type=chunk) [SIGNATURES](index=47&type=section&id=SIGNATURES) The report was duly signed on August 14, 2025, by Ryan M. Confer, serving as both Chief Executive Officer and Chief Financial Officer - The report was signed by Ryan M. Confer, Chief Executive Officer and Chief Financial Officer, on August 14, 2025[211](index=211&type=chunk)

Core Viewpoint - Genprex, Inc. has achieved significant clinical development milestones in 2025, focusing on advancing its gene therapy programs for cancer and diabetes, with ongoing clinical trials for lung cancer treatments [1][2]. Group 1: Company Achievements - The company has issued a stockholder letter summarizing recent achievements and outlining key milestones for 2025 and beyond [1]. - Genprex's lead product candidate, Reqorsa® Gene Therapy, is currently being evaluated in two clinical trials for non-small cell lung cancer (NSCLC) and small cell lung cancer (SCLC), both of which have received Fast Track Designation from the FDA [3]. - The SCLC program has also received Orphan Drug Designation from the FDA, indicating its potential to address unmet medical needs [3]. Group 2: Technology and Approach - Genprex utilizes a systemic, non-viral Oncoprex® Delivery System that encapsulates gene-expressing plasmids in lipid-based nanoparticles, administered intravenously to target tumor cells [3]. - The diabetes gene therapy approach involves a novel infusion process using an AAV vector to deliver Pdx1 and MafA genes directly to the pancreas, aiming to transform alpha cells into functional beta-like cells capable of producing insulin [3]. Group 3: Future Outlook - The company is focused on executing upcoming milestones in the second half of 2025 and beyond, with a commitment to transforming the lives of patients battling cancer and diabetes through innovative gene therapies [2].

Core Viewpoint - Genprex, Inc. has presented promising preclinical research on its diabetes gene therapy candidate GPX-002, demonstrating its potential to improve glucose homeostasis by reprogramming alpha cells into beta-like cells, as showcased at the 2025 American Diabetes Association Scientific Session [1][2]. Group 1: Research Findings - The research indicates that alpha cells in animal models of Type 1 diabetes (T1D) can transdifferentiate into beta-like cells after being treated with GPX-002, maintaining improved glucose control for three months [2][6]. - The gene therapy utilizes recombinant adeno-associated virus (rAAV) to deliver Pdx1 and MafA genes directly into the pancreatic duct, effectively converting alpha cells into insulin-secreting beta-like cells without the need for immunosuppression in mouse models [3][12]. - In non-human primate studies, the infusion of rAAV resulted in improved glucose tolerance and reduced insulin requirements one month post-infusion, with ongoing evaluations of immune responses to the therapy [5][8]. Group 2: Clinical Development - Genprex is advancing GPX-002 for both Type 1 and Type 2 diabetes, with the same gene therapy approach applied to both conditions, aiming to rejuvenate exhausted beta cells in Type 2 diabetes [9][12]. - The company is currently conducting preclinical studies to gather additional data on the efficacy of GPX-002 after six months of immunosuppression [8][9]. - The therapy is designed to be administered via a routine endoscopy procedure in humans, enhancing its potential for clinical application [9]. Group 3: Company Overview - Genprex, Inc. is a clinical-stage gene therapy company focused on developing innovative therapies for cancer and diabetes, collaborating with leading institutions to advance its drug candidates [10][11]. - The company’s oncology program includes the Oncoprex® Delivery System, which encapsulates gene-expressing plasmids for intravenous administration, targeting tumor cells [11]. - Genprex aims to provide new treatment options for patients with limited alternatives, leveraging its gene therapy technologies [10].

Novel Diabetes Gene Therapy Shows Potential for Re-Dosing Using Non-Viral Delivery System AUSTIN, Texas, June 23, 2025 /PRNewswire/ -- Genprex, Inc. ("Genprex" or the "Company") (NASDAQ: GNPX), a clinical-stage gene therapy company focused on developing life-changing therapies for patients with cancer and diabetes, today announced that its research collaborators presented positive preclinical data and research from studies of GPX-002, the Company's diabetes gene therapy drug candidate, at the 2025 American ...

Company Overview - Genprex, Inc. is a clinical-stage gene therapy company focused on developing therapies for cancer and diabetes [4] - The company utilizes a systemic, non-viral Oncoprex® Delivery System to administer gene therapies [4] - Genprex's lead product candidate, Reqorsa® Gene Therapy, is being evaluated in clinical trials for non-small cell lung cancer (NSCLC) and small cell lung cancer (SCLC) [4] - The company has received Fast Track Designation from the FDA for its lung cancer programs and Orphan Drug Designation for its SCLC program [4] Upcoming Events - Genprex will participate in the BIO 2025 International Convention from June 16-19, 2025, in Boston, Massachusetts [1][3] - Thomas Gallagher, Senior Vice President of Intellectual Property and Licensing, will be available for one-on-one meetings during the conference [2] Technology and Innovation - Genprex's diabetes gene therapy approach involves a novel infusion process using an AAV vector to deliver Pdx1 and MafA genes to the pancreas [4] - In Type 1 diabetes models, GPX-002 transforms alpha cells into functional beta-like cells capable of producing insulin [4] - For Type 2 diabetes, GPX-002 is believed to rejuvenate and replenish exhausted beta cells [4] Industry Context - The BIO International Convention is the largest biotechnology event, attracting 20,000 industry leaders globally [3] - Genprex collaborates with world-class institutions to develop its drug candidates and expand its gene therapy pipeline [4]

Core Viewpoint - Genprex, Inc. is advancing its diabetes gene therapy candidate GPX-002, which shows promise in treating both Type 1 and Type 2 diabetes, as evidenced by positive preclinical data presented at the ASGCT Annual Meeting [1][2]. Group 1: Research and Development - GPX-002 utilizes recombinant adeno-associated virus (rAAV) to deliver Pdx1 and MafA genes, converting alpha cells into beta-like cells that secrete insulin, effectively reversing diabetes in mouse models without the need for immunosuppression [2][3]. - The therapy has been tested in cynomolgus macaques with streptozotocin-induced diabetes, demonstrating improved glucose tolerance and reduced insulin requirements one month post-infusion [4][5]. - Ongoing preclinical studies are evaluating the long-term efficacy of GPX-002 after six months of immunosuppression in non-human primate models for both Type 1 and Type 2 diabetes [6]. Group 2: Presentation Details - The oral presentation at the ASGCT Annual Meeting was titled "Immune Modulation Sustains Alpha Cell Reprogramming and Mitigates Immune Responses to AAV in a Diabetic Non-Human Primate Model," presented by Dr. Hannah Rinehardt [2]. - The presentation highlighted the challenges of managing immune responses to the therapy, indicating that temporary immunosuppression can effectively prevent anti-viral immunity but may need to be extended beyond three months [4][5]. Group 3: Company Overview - Genprex, Inc. is a clinical-stage gene therapy company focused on developing innovative therapies for cancer and diabetes, utilizing advanced technologies to deliver disease-fighting genes [8]. - The company’s approach for diabetes involves a novel infusion process using an AAV vector to directly administer therapeutic genes into the pancreas, with the potential for routine endoscopic procedures in humans [7][8].

Clinical Trials - The company is currently enrolling patients in the Phase 2a expansion portion of the Acclaim-1 clinical trial, which combines REQORSA and AstraZeneca's Tagrisso for late-stage NSCLC patients [120]. - The recommended Phase 2 dose (RP2D) of REQORSA in the Acclaim-1 trial is determined to be 0.12 mg/kg, which is twice the highest dose level delivered in previous trials [120]. - The Phase 2a expansion portion of the Acclaim-1 trial is expected to enroll approximately 33 patients who have progressed on Tagrisso or Tagrisso-containing regimens [120]. - The FDA has granted Fast Track Designation for the Acclaim-1 treatment combination of REQORSA and Tagrisso in NSCLC patients [121]. - The Acclaim-3 clinical trial is currently enrolling patients using a combination of REQORSA and Genentech's Tecentriq for extensive stage small cell lung cancer (ES-SCLC) [124]. - The RP2D of REQORSA in the Acclaim-3 trial is also set at 0.12 mg/kg, based on safety data showing no dose limiting toxicities [124]. - The Acclaim-3 trial aims to enroll approximately 50 patients across 10 to 15 U.S. sites, with a primary endpoint of determining the 18-week progression-free survival rate [124]. - The Acclaim-3 clinical trial has received FDA Fast Track Designation and Orphan Drug Designation for the patient population [125]. - The company expects interim enrollment of the Phase 2a expansion portion of the Acclaim-1 trial to be completed by the end of 2025 [153]. Financial Performance - Research and development (R&D) expense for Q1 2025 was $2,539,993, a decrease of 22% from $3,274,380 in Q1 2024, primarily due to the closure of the Acclaim-2 clinical trial and a reduction in R&D staff from 15 to 9 employees [143]. - General and administrative (G&A) expense for Q1 2025 was $1,429,299, down 47% from $2,719,667 in Q1 2024, attributed to expense reduction strategies and a decrease in G&A staff from 11 to 6 employees [144]. - Net loss for Q1 2025 was $3,964,601, a reduction of 34% compared to $5,968,869 in Q1 2024, mainly due to decreased clinical and manufacturing expenses and overall staff reduction from 26 to 15 employees [147]. - As of March 31, 2025, the company had an accumulated deficit of $158,764,044, having never generated revenue from product sales since inception [148]. - In 2024, the company sold 5,366,503 shares of common stock for net proceeds of $6.3 million and completed a registered direct offering for approximately $5.8 million [149]. - During the three months ended March 31, 2025, the company sold 13,278,666 shares of common stock for gross proceeds of approximately $6.2 million, resulting in net proceeds of $6,028,103 after offering expenses [150]. - Net cash used in operating activities decreased by $1,136,466, or 21%, from $5,297,891 in Q1 2024 to $4,161,425 in Q1 2025, primarily due to the closure of the Acclaim-2 clinical trial and expense reduction strategies [156]. - Net cash provided by financing activities was $6,028,103 for the three months ended March 31, 2025, a decrease of $765,096 compared to $6,793,199 in Q1 2024 [158]. - The company had no net cash provided by or used in investing activities for the three months ended March 31, 2025, compared to a net cash outflow of $15,822 in Q1 2024 [157]. Strategic Focus - The company has entered into a sponsored research agreement with MD Anderson to support further preclinical studies of TUSC2 and other tumor suppressor genes [119]. - The company is focusing on optimizing and re-focusing its diabetes and oncology clinical development programs to enhance the likelihood of success [116]. - The company is currently developing GPX-002 for both Type 1 and Type 2 diabetes, with preclinical studies ongoing at the University of Pittsburgh [126]. - The company plans to seek further regulatory guidance from the FDA on IND-enabling studies in the second half of 2025 [126]. - A new sponsored research agreement with the University of Pittsburgh was established in May 2025 to study Type 1 and Type 2 diabetes in animal models [126]. - The company is exploring a non-viral lipid nanoparticle delivery system for multiple treatments [126]. - The company has implemented strategies to optimize clinical and research programs and is considering various strategic alternatives to enhance stockholder value [138]. - The company anticipates needing to raise additional capital to fund future operations, including ongoing clinical trials, as it does not expect to generate revenue from product sales in the near term [153]. - The company estimates it can fund its current operations and planned clinical trial activities through the end of the second quarter of 2025 [154]. - The company may seek additional capital through strategic collaborations or transactions, but there is uncertainty regarding its ability to maintain liquidity over the next 12 months [153]. - The company has utilized all available capacity under the current prospectus supplement for the 2023 ATM Facility as of the filing date of the Quarterly Report [153].

Core Viewpoint - Genprex, Inc. has announced a new Sponsored Research Agreement (SRA) with the University of Pittsburgh to further study its gene therapy GPX-002 for Type 1 and Type 2 diabetes in animal models, following the completion of a previous two-year agreement [1][2]. Company Overview - Genprex, Inc. is a clinical-stage gene therapy company focused on developing therapies for cancer and diabetes, utilizing innovative technologies to deliver disease-fighting genes [5][6]. - The company’s lead product candidate, Reqorsa® Gene Therapy, is under evaluation in clinical trials for non-small cell lung cancer (NSCLC) and small cell lung cancer (SCLC) [5]. Research and Development - The new SRA with the University of Pittsburgh will sponsor preclinical studies of GPX-002, which has shown promising results in reducing insulin requirements and improving glucose tolerance in animal models of diabetes [2][3]. - GPX-002 employs an adeno-associated virus (AAV) vector to deliver Pdx1 and MafA genes directly to the pancreas, aiming to transform alpha cells into functional beta-like cells in Type 1 diabetes and rejuvenate exhausted beta cells in Type 2 diabetes [3][6]. Market Context - As of 2024, approximately 38.4 million Americans have diabetes, with 10% having Type 1 diabetes and 90-95% having Type 2 diabetes. The global diabetes population is projected to rise from 537 million in 2021 to 783 million by 2045 [4]. - Diabetes caused over 6.7 million deaths globally in 2021 and resulted in approximately $966 billion in health expenditures, reflecting a significant increase over the past fifteen years [4].

Core Viewpoint - Genprex, Inc. announced positive preclinical data for Reqorsa® Gene Therapy, demonstrating its robust anti-tumor effects in KRASG12C mutant non-small cell lung cancer (NSCLC), both alone and in combination with LUMAKRAS® [1][2]. Group 1: Preclinical Data Presentation - The positive preclinical data was presented at the 2025 American Association for Cancer Research (AACR) Annual Meeting, highlighting the therapeutic potential of REQORSA in treating Ras inhibitor resistant lung cancer [1][2]. - The poster titled "Overcoming sotorasib acquired resistance in KRASG12C mutant NSCLC by TUSC2 gene therapy" showcased that TUSC2 gene therapy effectively overcomes acquired resistance to sotorasib in mouse xenografts [3]. Group 2: Efficacy of Reqorsa - TUSC2 transfection significantly reduced colony formation and increased apoptosis in acquired resistance cell lines, indicating strong anti-tumor efficacy [3]. - REQORSA alone showed a strong anti-tumor effect on TC314AR PDXs, while sotorasib alone exhibited no significant activity [3]. - A synergistic effect was observed when combining REQORSA with sotorasib, enhancing tumor control compared to either treatment alone [3]. Group 3: Technology and Delivery System - Reqorsa consists of a plasmid containing the TUSC2 gene encapsulated in non-viral lipid-based nanoparticles, specifically targeting cancer cells while minimizing uptake by normal tissue [5]. - Laboratory studies indicated that the uptake of TUSC2 in tumor cells after REQORSA treatment was 10 to 33 times higher than in normal cells [5]. Group 4: Company Overview - Genprex, Inc. is a clinical-stage gene therapy company focused on developing therapies for cancer and diabetes, utilizing its Oncoprex® Delivery System for gene administration [6][7]. - The company is advancing its pipeline of gene therapies and has received Fast Track Designation from the FDA for its lung cancer clinical programs [7].