Genprex, Inc.'s (GNPX) shares rose 9.5% after it announced the expansion of the Acclaim-3 clinical study of lead cancer candidate, Reqorsa, to additional trial sites.Under collaboration with a large network of community-based oncology practices, Genprex is adding multiple clinical study sites for the early to mid-stage combination study of Reqorsa Immunogene Therapy (quaratusugene ozeplasmid) to treat patients with extensive-stage small cell lung cancer (ES-SCLC). Reqorsa has been developed utilizing its pr ...

 Multiple clinical trial sites to be opened under collaboration with large network of community-based oncology practices               Acclaim-3 Study Supported by FDA Orphan Drug and Fast Track Designations AUSTIN, Texas, April 3, 2024 /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 through its collaboration agreement with a large networ ...

NPRL2 Gene Therapy Induces Anti-Tumor Activity in Anti-PD1 Resistant KRAS/STK11 Mutant Non-Small Cell Lung Cancer in a Humanized Mouse ModelProvides Additional Preclinical Validation of Oncoprex® Delivery System With Another Tumor Suppressor GeneAUSTIN, Texas, April 2, 2024 /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 colla ...

UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-K (Mark One) ☒ ANNUAL REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the fiscal year ended December 31, 2023 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 incorporation or organizat ...

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, 2023 or UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 ☐ 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 othe ...

PART I FINANCIAL INFORMATION This section covers unaudited financial statements, management's discussion, market risk, and internal controls [Financial Statements (unaudited)](index=4&type=section&id=ITEM%201.%20FINANCIAL%20STATEMENTS%20%28unaudited%29) This section presents the unaudited condensed financial statements, highlighting a decline in assets and increasing net losses, raising going concern doubts [Condensed Balance Sheets](index=4&type=section&id=Condensed%20Balance%20Sheets) The balance sheets show a significant decrease in cash and total assets, alongside a sharp decline in stockholders' equity Condensed Balance Sheet Data (in thousands) | Account | June 30, 2023 | December 31, 2022 | | :--- | :--- | :--- | | **Assets** | | | | Cash and cash equivalents | $9,955.7 | $20,954.1 | | Total current assets | $12,366.1 | $21,473.1 | | Total assets | $15,911.1 | $25,085.0 | | **Liabilities & Equity** | | | | Total current liabilities | $3,860.2 | $2,810.3 | | Total stockholders' equity | $12,050.9 | $22,274.7 | | Total liabilities and stockholders' equity | $15,911.1 | $25,085.0 | [Condensed Statements of Operations](index=5&type=section&id=Condensed%20Statements%20of%20Operations) The statements of operations reveal no revenue and widening net losses, primarily due to increased operating expenses Condensed Statements of Operations (in thousands) | Metric | Three Months Ended June 30, 2023 | Three Months Ended June 30, 2022 | Six Months Ended June 30, 2023 | Six Months Ended June 30, 2022 | | :--- | :--- | :--- | :--- | :--- | | Research and development | $3,976.9 | $2,926.9 | $9,287.1 | $4,967.2 | | General and administrative | $4,055.0 | $2,836.9 | $8,012.1 | $6,100.7 | | Operating loss | $(8,035.7) | $(5,770.4) | $(17,307.0) | $(11,081.1) | | Net loss | $(7,980.2) | $(5,764.6) | $(17,183.0) | $(11,074.5) | | Net loss per share | $(0.15) | $(0.12) | $(0.34) | $(0.23) | [Condensed Statements of Cash Flows](index=7&type=section&id=Condensed%20Statements%20of%20Cash%20Flows) Cash flow statements indicate increased cash usage in operations, partially offset by financing activities, leading to a net cash decrease Cash Flow Summary (in thousands) | Cash Flow Activity | Six Months Ended June 30, 2023 | Six Months Ended June 30, 2022 | | :--- | :--- | :--- | | Net cash used in operating activities | $(15,039.5) | $(8,552.2) | | Net cash used in investing activities | $(39.6) | $(23.7) | | Net cash provided by financing activities | $4,080.8 | $0.0 | | Net decrease in cash and cash equivalents | $(10,998.4) | $(8,575.9) | | Cash and cash equivalents, end of period | $9,955.7 | $30,053.0 | [Notes to Unaudited Condensed Financial Statements](index=8&type=section&id=Notes%20to%20Unaudited%20Condensed%20Financial%20Statements) These notes provide details on the company's business, significant accounting policies, and the going concern uncertainty due to recurring losses - The company is a clinical-stage gene therapy company focusing on oncology (ONCOPREX® platform) and diabetes treatments[23](index=23&type=chunk) - There is substantial doubt about the company's ability to continue as a going concern due to recurring losses and the need for additional financing to fund operations[36](index=36&type=chunk) - Current cash and proceeds from a July 2023 offering are expected to fund operations into the third quarter of 2024[35](index=35&type=chunk) - In March 2023, the company completed a registered direct offering, raising net proceeds of approximately **$3.6 million**[59](index=59&type=chunk) - Subsequent to the quarter end, in July 2023, the company completed another registered direct offering, raising net proceeds of approximately **$6.7 million**[99](index=99&type=chunk) [Management's Discussion and Analysis of Financial Condition and Results of Operations](index=23&type=section&id=ITEM%202.%20MANAGEMENT%27S%20DISCUSSION%20AND%20ANALYSIS%20OF%20FINANCIAL%20CONDITION%20AND%20RESULTS%20OF%20OPERATIONS) Management discusses the company's gene therapy programs, clinical trial progress, manufacturing delays, and the precarious liquidity position [Overview](index=25&type=section&id=Overview) This overview details the company's clinical-stage gene therapy programs, including ongoing trials and a noted manufacturing delay for REQORSA - The Acclaim-1 trial advanced to the Phase 2 expansion portion in May 2023, with the first patient expected to be dosed in **Q4 2023**[110](index=110&type=chunk) - The Acclaim-2 trial is currently enrolling patients in the Phase 1 dose escalation portion, with completion expected in **Q2 2024**[111](index=111&type=chunk) - The Acclaim-3 trial for small cell lung cancer (SCLC) is expected to dose its first patient in **Q4 2023**[112](index=112&type=chunk) - A delay in the production of a new batch of REQORSA may delay patient treatment in ongoing trials and the start of new trial portions, with a new batch expected in **Q4 2023**[29](index=29&type=chunk)[113](index=113&type=chunk)[114](index=114&type=chunk) [Results of Operations](index=31&type=section&id=Results%20of%20Operations) Operating expenses, including R&D and G&A, significantly increased, leading to a wider net loss for the three and six months ended June 30, 2023 Comparison of Operating Expenses (in thousands) | Expense Category | Three Months Ended June 30, 2023 | Three Months Ended June 30, 2022 | Six Months Ended June 30, 2023 | Six Months Ended June 30, 2022 | | :--- | :--- | :--- | :--- | :--- | | R&D Expense | $3,976.9 | $2,926.9 | $9,287.1 | $4,967.2 | | G&A Expense | $4,055.0 | $2,836.9 | $8,012.1 | $6,100.7 | | Net Loss | $(7,980.2) | $(5,764.6) | $(17,183.0) | $(11,074.5) | [Liquidity and Capital Resources](index=31&type=section&id=Liquidity%20and%20Capital%20Resources) The company's liquidity is constrained, with current cash expected to fund operations only into Q3 2024, necessitating additional capital and raising going concern doubts - As of June 30, 2023, the company had **$9.96 million** in cash and cash equivalents[148](index=148&type=chunk) - In July 2023, a registered direct offering raised approximately **$6.7 million** in net proceeds[148](index=148&type=chunk) - Current cash is estimated to fund operations and clinical trials into the **third quarter of 2024**[150](index=150&type=chunk) - Net cash used in operating activities increased by **76%** to **$15.0 million** for the six months ended June 30, 2023, compared to the prior year period[152](index=152&type=chunk) [Quantitative and Qualitative Disclosures About Market Risk](index=35&type=section&id=ITEM%203.%20QUANTITATIVE%20AND%20QUALITATIVE%20DISCLOSURES%20ABOUT%20MARKET%20RISK) The company is a "smaller reporting company" as defined by the Exchange Act and is therefore not required to provide information for this item - As a "smaller reporting company," Genprex is exempt from providing quantitative and qualitative disclosures about market risk[155](index=155&type=chunk) [Controls and Procedures](index=35&type=section&id=ITEM%204.%20CONTROLS%20AND%20PROCEDURES) Management concluded that disclosure controls and procedures were ineffective due to material weaknesses, with remediation efforts underway - Disclosure controls and procedures were determined to be **not effective** as of June 30, 2023[156](index=156&type=chunk) - Material weaknesses identified include a lack of segregation of duties and insufficient depth of in-house accounting personnel for complex transactions[156](index=156&type=chunk)[157](index=157&type=chunk) - Remediation plans include implementing new accounting software, enhancing review procedures, forming a Disclosure Committee, and hiring additional staff[159](index=159&type=chunk)[160](index=160&type=chunk) PART II OTHER INFORMATION This section covers legal proceedings, risk factors, equity sales, defaults, mine safety, and exhibits [Legal Proceedings](index=37&type=section&id=ITEM%201.%20LEGAL%20PROCEEDINGS) The company is not currently aware of any legal proceedings or claims that would have a material adverse effect on its business, financial condition, or operating results - The company is not currently involved in any material legal proceedings[166](index=166&type=chunk) [Risk Factors](index=37&type=section&id=ITEM%201A.%20RISK%20FACTORS) As a "smaller reporting company," Genprex is not required to provide the information for this item - The company is not required to provide risk factor disclosures in this report as it qualifies as a "smaller reporting company"[167](index=167&type=chunk) [Unregistered Sales of Equity Securities and Use of Proceeds](index=37&type=section&id=ITEM%202.%20UNREGISTERED%20SALES%20OF%20EQUITY%20SECU RITIES%20AND%20USE%20OF%20PROCEEDS) The company issued 5,000 common shares for services rendered, relying on a Securities Act exemption for unregistered sales - On April 1, 2023, **5,000 shares** of common stock were issued for services to the Chairman of the Scientific Advisory Board[168](index=168&type=chunk) - The issuance was exempt from registration under Section 4(a)(2) of the Securities Act[169](index=169&type=chunk) [Defaults Upon Senior Securities](index=37&type=section&id=ITEM%203.%20DEFAULTS%20UPON%20SENIOR%20SECURITIES) There were no defaults upon senior securities during the reporting period - There were no defaults upon senior securities during the reporting period[170](index=170&type=chunk) [Mine Safety Disclosures](index=37&type=section&id=ITEM%204.%20MINE%20SAFETY%20DISCLOSURES) This item is not applicable to the company - This item is not applicable to the company[171](index=171&type=chunk) [Other Information](index=37&type=section&id=ITEM%205.%20OTHER%20INFORMATION) There is no other information to report for this item - There is no other information to report for this item[172](index=172&type=chunk) [Exhibits](index=37&type=section&id=ITEM%206.%20EXHIBITS) This section lists the exhibits filed with the Form 10-Q, including certifications by the CEO and CFO as required by the Sarbanes-Oxley Act of 2002 and Inline XBRL documents

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 (State or other jurisdiction of (I.R.S. Employer incorporation or organization) Identification No.) Delaware 90-0772347 3300 Bee Cave Road, #650-227, Austin, TX 78746 (Address of principal executive offices) (Zip Code) For the quarterly period ended March 31, 2023 or ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SE ...

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 ...