Part I [Business](index=4&type=section&id=Item%201.%20Business) Genprex is a clinical-stage gene therapy company developing cancer and diabetes treatments through its ONCOPREX® and AAV platforms [Overview](index=4&type=section&id=Item%201.%20Business-Overview) Genprex is a clinical-stage gene therapy company with two main platforms. The first is an oncology platform using the non-viral ONCOPREX® Nanoparticle Delivery System to deliver tumor suppressor genes for cancer treatment. The second is a diabetes technology platform designed to treat Type 1 and Type 2 diabetes by transforming pancreatic cells to produce insulin. The company has recently conducted financings, including an At-the-Market (ATM) offering and a registered direct offering, to fund its operations - The company's oncology platform uses the **ONCOPREX® Nanoparticle Delivery System** to re-express deleted tumor suppressor genes in cancer cells[17](index=17&type=chunk) - The diabetes platform aims to transform pancreatic alpha cells into functional beta-like cells for **Type 1 diabetes** and to replenish beta cells for **Type 2 diabetes**[17](index=17&type=chunk) - Completed a **registered direct offering** on March 1, 2023, raising net proceeds of approximately **$3.6 million**[26](index=26&type=chunk) - Initiated an **At-the-Market (ATM) offering program** in November 2022 for up to **$50.0 million**, with minimal sales of **$4,532** as of December 31, 2022[25](index=25&type=chunk) [Our Pipeline](index=5&type=section&id=Item%201.%20Business-Our%20Pipeline) Genprex's pipeline is focused on gene therapies for cancer and diabetes. The lead candidate, REQORSA®, is being developed for NSCLC and SCLC in combination with existing targeted and immunotherapies. The diabetes program includes preclinical candidates GPX-002 and GPX-003 Genprex Product Development Pipeline | Product Candidate | Indication | Development Stage | | :--- | :--- | :--- | | **ONCOLOGY** | | | | REQORSA® + Tagrisso® (Acclaim-1) | NSCLC | Phase 1/2 | | REQORSA® + Keytruda® (Acclaim-2) | NSCLC | Phase 1/2 | | REQORSA® + Tecentriq® (Acclaim-3) | SCLC | Phase 1/2 | | **DIABETES** | | | | GPX-002 | Type 1 Diabetes | Preclinical | | GPX-003 | Type 2 Diabetes | Preclinical | [Oncology Program](index=6&type=section&id=Item%201.%20Business-Oncology%20Program) The oncology program is centered on REQORSA®, an immunogene therapy delivering the TUSC2 tumor suppressor gene via the ONCOPREX® Nanoparticle Delivery System. TUSC2 is absent in a high percentage of lung cancers (82% of NSCLCs, 100% of SCLCs). REQORSA has a multimodal action, interrupting cancer cell proliferation, inducing apoptosis, and modulating the immune response. The company is conducting three key clinical trials: Acclaim-1 (with Tagrisso for NSCLC), Acclaim-2 (with Keytruda for NSCLC), and Acclaim-3 (with Tecentriq for SCLC). Both Acclaim-1 and Acclaim-2 have received FDA Fast Track Designation - **REQORSA® delivers the TUSC2 tumor suppressor gene**, which is reduced or absent in approximately **82% of NSCLCs and 100% of SCLCs**[49](index=49&type=chunk) - The **ONCOPREX® Nanoparticle Delivery System** uses positively charged lipid nanoparticles to target negatively charged cancer cells, delivering the TUSC2 gene intravenously[43](index=43&type=chunk)[60](index=60&type=chunk) - **Acclaim-1 trial** combines REQORSA® with Tagrisso® for late-stage NSCLC patients who have progressed on Tagrisso. The trial is in the final cohort of its Phase 1 dose escalation[19](index=19&type=chunk)[73](index=73&type=chunk) - **Acclaim-2 trial** combines REQORSA® with Keytruda® for late-stage NSCLC patients who have progressed on Keytruda. Enrollment in the Phase 1 dose escalation is expected to complete by the end of 2023[20](index=20&type=chunk)[79](index=79&type=chunk) - **Acclaim-3 trial** will combine REQORSA® with Tecentriq® as maintenance therapy for extensive-stage SCLC. The first patient is expected to be dosed by the end of Q3 2023[22](index=22&type=chunk)[82](index=82&type=chunk) - The FDA has granted **Fast Track Designation** for both the **Acclaim-1 trial** and **Acclaim-2 trial** combination therapies[19](index=19&type=chunk)[20](index=20&type=chunk) [Diabetes Program](index=23&type=section&id=Item%201.%20Business-Diabetes%20Program) Genprex's diabetes program, licensed from the University of Pittsburgh, uses an AAV vector to deliver Pdx1 and MafA genes directly to the pancreas. GPX-002 for Type 1 diabetes aims to convert alpha cells into insulin-producing beta-like cells that can evade the immune system. GPX-003 for Type 2 diabetes is designed to rejuvenate existing beta cells. Recent preclinical data in a non-human primate (NHP) model of Type 1 diabetes showed that GPX-002 treatment led to decreased insulin requirements, increased c-peptide levels, and improved glucose tolerance - The diabetes gene therapy approach uses an **adeno-associated virus (AAV) vector** to deliver Pdx1 and MafA genes into the pancreatic duct[24](index=24&type=chunk)[129](index=129&type=chunk) - **GPX-002 (Type 1)** is designed to transform alpha cells into functional, insulin-producing beta-like cells that evade the immune system[24](index=24&type=chunk)[129](index=129&type=chunk) - **GPX-003 (Type 2)** is believed to replenish and rejuvenate insulin-making beta cells[24](index=24&type=chunk)[129](index=129&type=chunk) - Preclinical data in a non-human primate model of **Type 1 diabetes** showed **statistically significant therapeutic potential** for GPX-002, with treated animals showing decreased insulin requirements and improved glucose tolerance[136](index=136&type=chunk) [Process Development and Manufacturing](index=28&type=section&id=Item%201.%20Business-Process%20Development%20and%20Manufacturing) Genprex utilizes third-party contract development and manufacturing organizations (CDMOs) for its product candidates but has developed internal core competencies in CMC strategy, risk assessment, and supply chain management. For the oncology program, the company has established a robust, scalable cGMP manufacturing process for REQORSA, successfully transferring the technology from MD Anderson to CDMOs. For the earlier-stage diabetes program, it is working with the University of Pittsburgh to transfer manufacturing technologies for GPX-002 and GPX-003 to a network of CDMOs - The company uses **third-party CDMOs** for manufacturing but has developed **internal expertise in CMC strategy, risk assessment, and supply chain management**[144](index=144&type=chunk)[150](index=150&type=chunk) - Manufacturing for REQORSA has been **successfully transferred from MD Anderson to CDMOs** and scaled up for clinical trial supply in accordance with cGMP[144](index=144&type=chunk) - The company is currently transferring manufacturing processes for its diabetes candidates, **GPX-002 and GPX-003**, to a network of CDMOs[145](index=145&type=chunk) [Intellectual Property](index=28&type=section&id=Item%201.%20Business-Intellectual%20Property) Genprex's intellectual property strategy relies on patents, trade secrets, and trademarks. The company holds worldwide, exclusive licenses from MD Anderson for its oncology portfolio, which includes 14 issued patents and 13 pending applications expected to expire between 2024 and 2038. For its diabetes technologies, it has exclusive licenses from the University of Pittsburgh covering an issued patent and 7 pending applications, expected to expire between 2035 and 2043. The company also holds registered trademarks for GENPREX®, REQORSA®, and ONCOPREX® - Holds **exclusive licenses from MD Anderson** for oncology technologies, covering **14 issued patents and 13 pending applications**[148](index=148&type=chunk) - Holds **exclusive licenses from the University of Pittsburgh** for diabetes technologies, covering **1 issued patent and 7 pending applications**[148](index=148&type=chunk) - Owns **registered trademarks for GENPREX®, REQORSA®, and ONCOPREX®**[149](index=149&type=chunk) [Licenses and Research Collaborations](index=29&type=section&id=Item%201.%20Business-Licenses%20and%20Research%20Collaborations) Genprex's core technologies are secured through key license agreements. The ONCOPREX® and REQORSA® technologies are licensed from MD Anderson, requiring royalty payments of 1.5% of net sales to MD Anderson and 1.0% to Introgen Research Institute (IRI). A 2020 agreement with MD Anderson for TUSC2 in combination with immunotherapies involves up to $6.15 million in milestone payments and tiered royalties. The diabetes technologies are licensed from the University of Pittsburgh under three separate agreements, each requiring an initial fee, annual maintenance fees, milestone payments up to $3.975 million, and tiered royalties - The primary oncology technology is licensed from MD Anderson, with a **1.5% royalty on net sales** payable to MD Anderson and a **1.0% royalty payable to IRI**[159](index=159&type=chunk) - A 2020 license with MD Anderson for TUSC2 with immunotherapies includes **up to $6.15 million in milestone payments** and **low single-digit to low double-digit royalties**[160](index=160&type=chunk) - Three separate exclusive license agreements with the University of Pittsburgh cover diabetes gene therapies, each with **potential milestone payments of up to $3.975 million plus royalties**[163](index=163&type=chunk)[164](index=164&type=chunk) [Government Regulation](index=32&type=section&id=Item%201.%20Business-Government%20Regulation) Genprex's products are subject to extensive regulation by the FDA in the U.S. and other global authorities. Gene therapy products are regulated as biologics and require a Biologics License Application (BLA) for marketing approval, a process involving preclinical studies and multi-phase clinical trials under Good Laboratory, Clinical, and Manufacturing Practices (GLP, GCP, GMP). The company has received two Fast Track Designations from the FDA for its lead programs. The regulatory landscape also includes post-approval requirements, potential for orphan drug designation, and compliance with fraud, abuse, and privacy laws like the Anti-Kickback Statute and HIPAA - Gene therapy products are regulated by the **FDA's Center for Biologics Evaluation and Research (CBER)** and require an approved **Biologics License Application (BLA)** for marketing[173](index=173&type=chunk)[175](index=175&type=chunk) - The FDA has **four expedited programs**: Fast Track Designation, Breakthrough Therapy Designation, Accelerated Approval, and Priority Review. Genprex has received **two Fast Track Designations for REQORSA**[196](index=196&type=chunk)[197](index=197&type=chunk) - The company's activities are also subject to **federal and state fraud and abuse laws**, including the **Anti-Kickback Statute, False Claims Act, and privacy laws like HIPAA**[220](index=220&type=chunk)[222](index=222&type=chunk) [Risk Factors](index=46&type=section&id=Item%201A.%20Risk%20Factors) The company faces significant financial, operational, and regulatory risks, including a history of losses and reliance on third parties - **Financial Risk**: The company has a history of net losses (**$100.4 million** accumulated deficit as of Dec 31, 2022), has never been profitable, and requires substantial additional funding to continue operations. **Existing cash is expected to fund operations into Q2 2024**[266](index=266&type=chunk)[268](index=268&type=chunk)[273](index=273&type=chunk) - **Development & Commercialization Risk**: **Success depends heavily on REQORSA, GPX-002, and GPX-003**. Clinical trials face risks of failure, delays in patient enrollment, and undesirable side effects. The COVID-19 pandemic has caused and may continue to cause trial delays and supply chain disruptions[281](index=281&type=chunk)[289](index=289&type=chunk)[311](index=311&type=chunk) - **Third-Party Dependence Risk**: The company relies on **third-party CDMOs** for manufacturing and CROs for clinical trials. Any failure by these parties to perform, maintain cGMP compliance, or meet deadlines could significantly harm development programs[355](index=355&type=chunk)[358](index=358&type=chunk) - **Intellectual Property Risk**: The company's business depends on licenses from MD Anderson and the University of Pittsburgh. Failure to comply with license terms could result in loss of rights. The licensed IP is also subject to U.S. government rights due to federal funding[367](index=367&type=chunk)[371](index=371&type=chunk) - **Regulatory Risk**: There is no assurance that product candidates will receive regulatory approval. Even if approved, products will be subject to extensive ongoing regulatory oversight, and coverage and reimbursement from payors are uncertain[319](index=319&type=chunk)[328](index=328&type=chunk)[340](index=340&type=chunk) [Unresolved Staff Comments](index=78&type=section&id=Item%201B.%20Unresolved%20Staff%20Comments) No unresolved staff comments were reported [Properties](index=78&type=section&id=Item%202.%20Properties) The company operates virtually and does not own real property, with its principal office in Austin, Texas - The company **operates as a virtual company** and **does not own any real property**[435](index=435&type=chunk) [Legal Proceedings](index=78&type=section&id=Item%203.%20Legal%20Proceedings) The company is not aware of any material legal proceedings or claims impacting its operations - As of the report date, the company is **not aware of any material legal proceedings**[436](index=436&type=chunk) [Mine Safety Disclosures](index=78&type=section&id=Item%204.%20Mine%20Safety%20Disclosures) Mine safety disclosures are not applicable to the company's operations Part II [Market for Registrant's Common Equity, Related Stockholder Matters and Issuer Purchases of Equity Securities](index=79&type=section&id=Item%205.%20Market%20for%20Registrant%27s%20Common%20Equity%2C%20Related%20Stockholder%20Matters%20and%20Issuer%20Purchases%20of%20Equity%20Securities) The company's common stock trades on Nasdaq, has never paid dividends, and issued unregistered securities in 2022 - Common stock trades on **The Nasdaq Capital Market under the symbol "GNPX"**[440](index=440&type=chunk) - The company has **never declared or paid cash dividends** and does not intend to in the foreseeable future[442](index=442&type=chunk) - In 2022, the company issued an aggregate of **81,752 shares of common stock and a warrant for 3,000 shares** to consultants as compensation for services in unregistered transactions[443](index=443&type=chunk)[445](index=445&type=chunk) [Management's Discussion and Analysis of Financial Condition and Results of Operations](index=80&type=section&id=Item%207.%20Management%27s%20Discussion%20and%20Analysis%20of%20Financial%20Condition%20and%20Results%20of%20Operations) Net loss increased in 2022 due to higher R&D and G&A expenses, with current cash projected to fund operations into Q2 2024 [Results of Operations](index=84&type=section&id=Item%207.%20Management%27s%20Discussion%20and%20Analysis%20of%20Financial%20Condition%20and%20Results%20of%20Operations-Results%20of%20Operations) For the year ended December 31, 2022, Genprex reported a net loss of $23.7 million, a 15% increase from the $20.7 million net loss in 2021. This was driven by a $2.5 million (28%) increase in R&D expenses to $11.5 million, due to manufacturing and clinical trial activities for Acclaim-1 and Acclaim-2. General & Administrative expenses rose by $0.6 million (5%) to $12.3 million, mainly from increased headcount Comparison of Operating Results (Years Ended Dec 31) | Metric | 2022 | 2021 | Change | % Change | | :--- | :--- | :--- | :--- | :--- | | R&D Expense | $11,510,074 | $8,970,865 | +$2,539,209 | +28% | | G&A Expense | $12,295,070 | $11,676,703 | +$618,367 | +5% | | Net Loss | $23,740,621 | $20,664,969 | +$3,075,652 | +15% | - The **28% increase in R&D expense** was primarily due to advancements in manufacturing programs and increased use of CROs for the Acclaim-1 and Acclaim-2 clinical trials[472](index=472&type=chunk) - The **5% increase in G&A expense** was mainly due to an increase in G&A headcount from 7 to 10 full-time employees[473](index=473&type=chunk) [Liquidity and Capital Resources](index=85&type=section&id=Item%207.%20Management%27s%20Discussion%20and%20Analysis%20of%20Financial%20Condition%20and%20Results%20of%20Operations-Liquidity%20and%20Capital%20Resources) As of December 31, 2022, Genprex had $21.0 million in cash and an accumulated deficit of $102.8 million. The company has funded operations primarily through equity sales, including a $50 million ATM facility established in November 2022 and a registered direct offering in March 2023 that raised approximately $3.6 million in net proceeds. Management estimates current cash is sufficient to fund operations and planned clinical trials into the second quarter of 2024. However, significant additional capital will be necessary to complete development and commercialize its product candidates - As of December 31, 2022, the company had **$20,954,069 in cash** and an **accumulated deficit of $102,827,819**[478](index=478&type=chunk)[480](index=480&type=chunk) - The company estimates its current cash will **fund operations and planned clinical activities into the second quarter of 2024**[482](index=482&type=chunk) - Subsequent to year-end, the company raised **approximately $3.6 million** in net proceeds from a registered direct offering on March 1, 2023[480](index=480&type=chunk) - An **At-the-Market (ATM) facility** for **up to $50.0 million** was established in November 2022, with minimal proceeds raised by year-end[479](index=479&type=chunk) Cash Flow Summary (Years Ended Dec 31) | Cash Flow Activity | 2022 | 2021 | | :--- | :--- | :--- | | Net cash used in operating activities | $(17,778,964) | $(14,284,924) | | Net cash provided (used) in investing activities | $97,731 | $(83,796) | | Net cash provided in financing activities | $6,426 | $25,677,911 | [Financial Statements and Supplementary Data](index=87&type=section&id=Item%208.%20Financial%20Statements%20and%20Supplementary%20Data) This section presents the company's audited financial statements and the independent auditor's report for 2021 and 2022 - 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**[492](index=492&type=chunk) [Changes in and Disagreements With Accountants on Accounting and Financial Disclosure](index=87&type=section&id=Item%209.%20Changes%20in%20and%20Disagreements%20With%20Accountants%20on%20Accounting%20and%20Financial%20Disclosure) No changes in or disagreements with accountants on accounting and financial disclosure were reported [Controls and Procedures](index=88&type=section&id=Item%209A.%20Controls%20and%20Procedures) Disclosure controls were ineffective as of December 31, 2022, due to a material weakness in segregation of duties, with remediation efforts underway - Management concluded that disclosure controls and procedures were **not effective as of December 31, 2022**[495](index=495&type=chunk) - A **material weakness in internal control over financial reporting** was identified due to a **lack of segregation of duties** in accounting functions[496](index=496&type=chunk)[499](index=499&type=chunk) - **Remediation plans are underway**, including implementing new accounting software processes, enhancing review procedures with legal and manufacturing teams, forming a Disclosure Committee, and hiring additional staff[501](index=501&type=chunk)[506](index=506&type=chunk) [Other Information](index=89&type=section&id=Item%209B.%20Other%20Information) No other material information was reported Part III [Directors, Executive Officers and Corporate Governance](index=90&type=section&id=Item%2010.%20Directors%2C%20Executive%20Officers%20and%20Corporate%20Governance) Information on directors, executive officers, and corporate governance is incorporated by reference from the 2023 proxy statement - Information is **incorporated by reference** from the definitive proxy statement for the 2023 annual meeting of stockholders[508](index=508&type=chunk) [Executive Compensation](index=90&type=section&id=Item%2011.%20Executive%20Compensation) Executive compensation information is incorporated by reference from the 2023 proxy statement - Information is **incorporated by reference** from the definitive proxy statement for the 2023 annual meeting of stockholders[510](index=510&type=chunk) [Security Ownership of Certain Beneficial Owners and Management and Related Stockholder Matters](index=90&type=section&id=Item%2012.%20Security%20Ownership%20of%20Certain%20Beneficial%20Owners%20and%20Management%20and%20Related%20Stockholder%20Matters) Security ownership and related stockholder matters are incorporated by reference from the 2023 proxy statement - Information is **incorporated by reference** from the definitive proxy statement for the 2023 annual meeting of stockholders[511](index=511&type=chunk) [Certain Relationships and Related Transactions, and Director Independence](index=90&type=section&id=Item%2013.%20Certain%20Relationships%20and%20Related%20Transactions%2C%20and%20Director%20Independence) Related party transactions and director independence information are incorporated by reference from the 2023 proxy statement - Information is **incorporated by reference** from the definitive proxy statement for the 2023 annual meeting of stockholders[512](index=512&type=chunk) [Principal Accountant Fees and Services](index=90&type=section&id=Item%2014.%20Principal%20Accountant%20Fees%20and%20Services) Principal accountant fees and services information is incorporated by reference from the 2023 proxy statement - Information is **incorporated by reference** from the definitive proxy statement for the 2023 annual meeting of stockholders[513](index=513&type=chunk) Part IV [Exhibits and Financial Statement Schedules](index=90&type=section&id=Item%2015.%20Exhibits%20and%20Financial%20Statement%20Schedules) This section lists financial statements, schedules, and exhibits filed as part of the Form 10-K, with financial statements starting on page F-1 - The financial statements required by this item begin on **page F-1**[515](index=515&type=chunk) - All financial statement schedules are omitted because the required information is inapplicable or already presented in the financial statements[516](index=516&type=chunk) Financial Statements [Report of Independent Registered Public Accounting Firm](index=97&type=section&id=Report%20of%20Independent%20Registered%20Public%20Accounting%20Firm) The auditor issued a fair opinion on the financial statements, highlighting equity transaction valuation as a critical audit matter and noting revised 2021 financials - The auditor issued a **standard opinion** on the financial statements[532](index=532&type=chunk) - A **critical audit matter** was identified related to the valuation of equity transactions, specifically stock options and warrants, due to the significant judgment involved[537](index=537&type=chunk)[538](index=538&type=chunk)[539](index=539&type=chunk) - The auditor noted that the **2021 financial statements have been revised**[533](index=533&type=chunk) [Financial Statements Tables](index=98&type=section&id=Financial%20Statements%20Tables) Financial tables show decreased assets and equity, increased net loss, and higher cash usage in operations for 2022 compared to 2021 Balance Sheet Data (as of December 31) | | 2022 | 2021 (Revised) | | :--- | :--- | :--- | | Cash | $20,954,069 | $38,628,876 | | Total Assets | $25,085,027 | $42,862,286 | | Total Liabilities | $2,810,287 | $1,585,295 | | Total Stockholders' Equity | $22,274,740 | $41,276,991 | Statement of Operations Data (for the year ended December 31) | | 2022 | 2021 (Revised) | | :--- | :--- | :--- | | Research and development | $11,510,074 | $8,970,865 | | General and administrative | $12,295,070 | $11,676,703 | | Net loss | $(23,740,621) | $(20,664,969) | | Net loss per share | $(0.50) | $(0.44) | Statement of Cash Flows Data (for the year ended December 31) | | 2022 | 2021 | | :--- | :--- | :--- | | Net cash used in operating activities | $(17,778,964) | $(14,284,924) | | Net cash provided by financing activities | $6,426 | $25,677,911 | [Notes to Financial Statements](index=102&type=section&id=Notes%20to%20Financial%20Statements) Notes detail accounting policies, equity transactions, and commitments, including a 2021 error correction and a March 2023 financing event - **Correction of Error**: The 2021 financial statements were revised to correct an error in recognizing share-based compensation expense for cliff-vesting awards. This increased the 2021 net loss by **$1,069,345**[563](index=563&type=chunk)[564](index=564&type=chunk) - **Commitments**: The company has a **contingent obligation to the NIH for $340,000** (as of Dec 31, 2022), payable upon FDA approval using NIH technology. It also has significant milestone and royalty commitments to MD Anderson and the University of Pittsburgh[608](index=608&type=chunk)[609](index=609&type=chunk)[611](index=611&type=chunk) - **Equity Plans**: The 2018 Equity Incentive Plan reserve was increased by **2,393,735 shares** on Jan 1, 2022. As of Dec 31, 2022, **481,772 shares** remained available for future awards[593](index=593&type=chunk) - **Subsequent Events**: On March 1, 2023, the company completed a **registered direct offering**, selling 3,809,524 shares and accompanying warrants, for net proceeds of **approximately $3.6 million**[626](index=626&type=chunk)

UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-Q (Mark One) ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended September 30, 2022 (Address of principal executive offices) (Zip Code) or ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from __________________ to ______________ Commission file number: 001-38244 GENPREX, INC. (Exact name of re ...

Genprex Nasdaq: GNPX 1 PIONEERING GENE THERAPIES FOR LARGE PATIENT POPULATIONS NASDAQ: GNPX October 2022 FORWARD-LOOKING STATEMENTS Statements contained in this presentation regarding matters that are not historical facts are "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995. Because such statements are subject to risks and uncertainties, actual results may differ materially from those expressed or implied by such forward-looking statements. Such stateme ...

UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-Q (Mark One) ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended June 30, 2022 or ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from __________________ to ______________ Commission file number: 001-38244 GENPREX, INC. (Exact name of registrant as specified in its charter) (State or other jur ...

UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-Q (Mark One) ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended March 31, 2022 or ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from __________________ to ______________ Commission file number: 001-38244 GENPREX, INC. (Exact name of registrant as specified in its charter) (State or other ju ...

Product Development and Clinical Trials - The company is developing REQORSA™ Immunogene Therapy for Non-Small Cell Lung Cancer (NSCLC) and Small Cell Lung Cancer (SCLC), utilizing a plasmid that expresses the tumor suppressor gene TUSC2[17]. - The company is currently enrolling two Phase 1/2 clinical trials for REQORSA, with Acclaim-1 expected to complete its Phase 1 portion by the end of 2022 and Acclaim-2 by Q1 2023[18]. - The company has expanded its pipeline to include SCLC and plans to commence a clinical trial by the end of 2022[23]. - The Acclaim-1 trial aims to enroll up to 92 patients, with the primary endpoint being progression-free survival for patients treated with REQORSA and Tagrisso[71][75]. - The Acclaim-2 trial is expected to enroll approximately 156 patients, focusing on the combination of REQORSA and Keytruda, with a primary endpoint of dose limiting toxicity[75][76]. - In the Phase 1 Monotherapy Trial, 22% of subjects achieved disease control for periods ranging from 2.6 to 10.8 months, with a median disease control period of 5.0 months[79]. - The median survival for all subjects in the Phase 1 Monotherapy Trial was 8.3 months, and the mean survival time was 13.2 months, with a range of 2 to 23+ months[79]. - In the Phase 2 portion of the trial, the disease control rate for nine evaluable patients was 78%[92]. - The response rate observed in the Phase 2 portion was 11%, with one patient achieving a complete response[92]. - The Phase 1 portion of the Phase 1/2 Combination Tarceva Trial included 18 subjects treated at various dose levels, with no dose-limiting toxicities reported[83][85]. Mechanism of Action and Efficacy - REQORSA has shown a multimodal mechanism of action, interrupting cancer cell signaling pathways, re-establishing apoptosis, and modulating the immune response[38]. - Tumor biopsy studies indicate that TUSC2 uptake in tumor cells after REQORSA treatment was 10 to 33 times higher than in normal cells[37]. - Clinical and preclinical data indicate that REQORSA combined with EGFR TKIs like Tagrisso and Keytruda may enhance anti-tumor activity, potentially benefiting a larger population of NSCLC patients[65][66][73]. - Preclinical studies have shown that TUSC2 enhances the immune response to cancer by down-regulating PD-L1 on cancer cells, thus promoting recognition by immune cells[52][66]. - The combination of REQORSA and Tarceva showed a significant improvement over the response rate of 7% and disease control rate of 58% reported for afatinib in the LUX-Lung 1 clinical trial[94]. - The combination therapy of REQORSA with Tarceva may benefit NSCLC patients with and without activating EGFR mutations[100]. - TUSC2 therapy in combination with osimertinib demonstrated synergistic antitumor efficacy in EGFR mutant osimertinib resistant NSCLC tumors, providing a rationale for the Acclaim-1 clinical trial[101]. - REQORSA shows a 10 to 33 fold differential favoring uptake by tumor cells, indicating its passive targeting property[102]. - Intratumoral administration of REQORSA resulted in significant tumor growth inhibition in A549 tumor xenografts[103]. - The combination of REQORSA and pembrolizumab inhibited tumor growth synergistically, with significant reductions in tumor burden (P<0.05 to P<0.0005)[109]. - REQORSA demonstrated synergistic antitumor activity with nivolumab, indicating its potential effectiveness with various immune checkpoint inhibitors[111]. Regulatory and Compliance Considerations - The FDA has granted two Fast Track Designations for REQORSA in the targeted patient populations of ongoing clinical trials[19]. - The FDA regulates the approval process for the company's biological product candidates, which involves substantial time and financial resources[157]. - The company must complete preclinical tests and submit an IND application to the FDA before human clinical trials can begin[159]. - The FDA requires two adequate and well-controlled Phase 3 clinical trials to demonstrate drug efficacy, with a single trial being sufficient in rare cases[166]. - The FDA's Accelerated Approval Program allows for expedited approval of product candidates for serious conditions based on surrogate endpoints, contingent on post-approval trials[186]. - Priority Review Designation aims for FDA action on marketing applications within six months, compared to ten months under standard review, facilitating faster market entry[188]. - The FDA may impose user fees on BLAs, which are adjusted annually under the Prescription Drug User Fee Act[173]. - The FDA mandates disclosure of clinical trial information, which can be used by competitors to gain insights into clinical development programs[198]. - The company must comply with various federal and state regulations, including those related to fraud and abuse, which apply once FDA marketing approval is obtained[204]. Intellectual Property and Financial Obligations - The company holds 18 issued patents and 17 pending patent applications related to TUSC2 and its therapeutic uses, supported by grants from various institutions[61]. - The company holds a worldwide, exclusive license to 18 issued patents and 17 pending patent applications related to REQORSA and its delivery system[133]. - The company is obligated to pay MD Anderson royalties of 1.5% of net sales of licensed products and 1.5% of advance payments received from third parties[144]. - The 2020 License Agreement with MD Anderson includes milestone payments aggregating up to a maximum of $6,150,000 and minimum annual royalties in a low six-figure amount[145]. - The UP License Agreement requires the company to pay milestone payments up to $3,975,000 and running royalties beginning with the first commercial sale of the licensed technology[149]. Competitive Landscape and Market Challenges - The company faces intense competition from major pharmaceutical companies and established biotechnology firms, which have greater financial resources and experience[154]. - In the U.S., there is significant uncertainty regarding the coverage and reimbursement status of new pharmaceutical products, which may be influenced by Medicare decisions[215].

UNITED STATES For the quarterly period ended September 30, 2021 SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-Q (Mark One) or ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from __________________ to ______________ Commission file number: 001-38244 GENPREX, INC. (Exact name of registrant as specified in its charter) (State or other jurisdiction of (I.R.S. Employer incorporation or organization) Identification No.) Delaw ...

UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 or ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from __________________ to ______________ Commission file number: 001-38244 GENPREX, INC. (Exact name of registrant as specified in its charter) (State or other jurisdiction of (I.R.S. Employer incorporation or organization) Identification No.) FORM 10-Q (Mark One) ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF ...

Genprex® Nasdaq: GNPX 1 REPROGRAMMING THE COURSE OF CANCER AND DIABETES NASDAQ: GNPX FORWARD-LOOKING STATEMENTS Statements contained in this presentation regarding matters that are not historical facts are "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995. Because such statements are subject to risks and uncertainties, actual results may differ materially from those expressed or implied by such forwardlooking statements. Such statements include, but are ...

UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-Q (Mark One) ☒ QUARTERLY REPORT UNDER SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended September 30, 2019 or ☐ TRANSITION REPORT UNDER SECTION 13 OR 15(d) OF THE EXCHANGE ACT For the transition period from __________________ to ______________ Commission file number: 001-38244 GENPREX, INC. (Exact name of registrant as specified in its charter) Delaware 90 - 0772347 (State or other jurisdi ...