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]

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, 2025 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 Achieves Multiple Clinical Development Milestones in 2025Patient Treatment Continues in Two Lung Cancer Clinical TrialsAUSTIN, Texas, Aug. 4, 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 it has issued a stockholder letter and corporate update summarizing the Company's recent achievements across its oncology and diabetes pro ...

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 Gene Therapy is Addressing Both Type 1 and Type 2 Diabetes AUSTIN, Texas, May 28, 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, announced that its research collaborators presented positive preclinical data and research from studies of GPX-002, the Company's diabetes gene therapy drug candidate, in an oral presentation at the American Society of Ge ...

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].

GPX-002 is currently being developed using the same construct for the treatment of both Type 1 diabetes (T1D) and Type 2 diabetes (T2D). The same general novel approach is used in each of T1D and T2D whereby an adeno-associated virus (AAV) vector containing the Pdx1 and MafA genes is administered directly into the pancreatic duct. In humans, this can be done with a routine endoscopy procedure. In T1D, GPX-002 is designed to work by transforming alpha cells in the pancreas into functional beta-like cells, wh ...

Both REQORSA Alone and in Combination with LUMAKRAS® Demonstrated Robust Anti-Tumor Effects in Ras Inhibitor Resistant Non-Small Cell Lung CancerAUSTIN, Texas, April 30, 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 for Reqorsa® Gene Therapy (quaratusugene ozeplasmid), f ...

Novel Gene Therapy Program Offers a Promising Opportunity for Curative Therapy in DiabetesAUSTIN, Texas, April 29, 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 have been selected to present at the upcoming American Society of Gene and Cell Therapy's (ASGCT) 28th Annual Meeting being held May 13-17, 2025 i ...

Additional Gene Therapy Technology Expands Genprex's Portfolio of Oncology LicensesAUSTIN, Texas, April 28, 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 it has signed an exclusive patent license agreement with NYU Langone Health related to the drug candidate, Reqorsa® Gene Therapy (quaratusugene ozeplasmid). The therapy is under investi ...