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 ...

Company Overview - The company is a clinical stage gene therapy firm focused on developing gene-based therapies for large patient populations with unmet medical needs [95]. Oncology Drug Development - The lead oncology drug candidate, REQORSA™ Immunogene Therapy, is in two Phase 1/2 clinical trials for Non-Small Cell Lung Cancer (NSCLC) and Small Cell Lung Cancer (SCLC) with expected completion of Phase 1 by early 2023 [97]. - The FDA has granted two Fast Track Designations for REQORSA in the targeted patient populations of the ongoing trials [98]. - The company has exclusive worldwide licenses for the TUSC2 gene from The University of Texas MD Anderson Cancer Center, enhancing its oncology platform [99]. - The oncology platform utilizes the ONCOPREX™ Nanoparticle Delivery System to deliver tumor suppressor genes to cancer cells [95]. - The first patient in the Acclaim-1 trial was dosed in February 2022, and the first patient in the Acclaim-2 trial was dosed in April 2022, with both trials currently open for enrollment [124]. - The Phase 1 portion of the Acclaim-1 trial is expected to be completed by the end of 2022, and the Acclaim-2 trial by the end of Q1 2023 [124]. Financial Performance - R&D expense for Q1 2022 was $1,860,837, a decrease of $308,306 or 14% compared to $2,169,143 in Q1 2021, primarily due to reduced expenditures in manufacturing programs [117]. - G&A expense for Q1 2022 was $3,855,796, down by $460,514 or 11% from $4,316,310 in Q1 2021, largely due to a one-time finance fee of $1,750,000 in the prior year [118]. - Net loss for Q1 2022 was $5,722,484, a decrease of $767,229 or 12% from $6,489,713 in Q1 2021, influenced by the absence of the one-time finance fee [121]. - As of March 31, 2022, the accumulated deficit was $83,740,337, with no revenue generated from product sales since inception [122]. - Cash and cash equivalents as of March 31, 2022, totaled $34,555,337, expected to fund operations and clinical trials into 2024 [124]. - Net cash used in operating activities for Q1 2022 was $4,083,857, a decrease of $1,381,425 or 25% from $5,465,282 in Q1 2021 [127]. - Net cash provided by investing activities was $10,319 in Q1 2022, compared to a net cash used of $110,030 in Q1 2021, reflecting a decrease of $120,349 or 109% [128]. - No cash was provided by financing activities in Q1 2022, a decrease of $25,324,330 or 100% from $25,324,330 in Q1 2021 due to lack of common stock sales [129]. Research and Development Outlook - The diabetes gene therapy aims to transform alpha cells in the pancreas into functional beta-like cells, currently in preclinical studies at the University of Pittsburgh [101]. - Research and development expenses are expected to increase as the company advances its product candidates through clinical trials and seeks regulatory approvals [113]. Risks and Challenges - The company faces risks including market conditions, competition from larger pharmaceutical companies, and the uncertainty of developing marketable products [93]. - A full valuation allowance has been provided on deferred tax assets due to a history of operating losses since inception [109].

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 ...

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 June 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) (State or other jurisdiction of (I.R.S. Employer i ...