Genprex Stock Price, News & Analysis

Genprex, Inc. (NASDAQ: GNPX) is a clinical-stage gene therapy company developing therapies for patients with cancer and diabetes. According to its public disclosures and press releases, Genprex focuses on administering disease‑fighting genes to address large patient populations that have limited treatment options in oncology and metabolic disease.

The company’s programs are built around two main technology platforms. Its oncology platform uses the systemic, non‑viral Oncoprex® Delivery System, which encapsulates gene‑expressing plasmids in lipid‑based nanoparticles in a lipoplex form. The resulting product is administered intravenously and taken up by tumor cells, where it is intended to restore expression of tumor suppressor proteins that were deficient in the cancer cells. Genprex’s lead oncology product candidate is Reqorsa® Gene Therapy (quaratusugene ozeplasmid), which consists of a plasmid containing the TUSC2 tumor suppressor gene delivered via the Oncoprex Delivery System.

Reqorsa is initially being developed in combination with approved cancer drugs to treat non‑small cell lung cancer (NSCLC) and small cell lung cancer (SCLC). Company materials state that Reqorsa has multimodal effects on cancer cells, including disrupting tumor glucose metabolism, interrupting signaling pathways that drive replication and proliferation, re‑establishing apoptotic (programmed cell death) pathways, and increasing immune responses against cancer cells. In preclinical studies described by Genprex, Reqorsa has shown activity both as a single agent and in combination with targeted therapies and immunotherapies.

Oncology clinical programs

Genprex is advancing Reqorsa through multiple lung cancer clinical trials. The Acclaim‑1 Phase 1/2 trial evaluates Reqorsa in combination with Tagrisso® (osimertinib) in patients with late‑stage NSCLC who have activating EGFR mutations and whose disease has progressed after prior osimertinib‑containing regimens. The Phase 1 dose‑escalation portion, as described in company reports, established a recommended Phase 2 dose and reported no dose‑limiting toxicities, with early signs of efficacy including prolonged progression‑free survival and a partial response in some patients. The ongoing Phase 2a expansion is designed to further characterize safety and efficacy in patients previously treated with Tagrisso.

The Acclaim‑3 Phase 1/2 trial evaluates Reqorsa in combination with Tecentriq® (atezolizumab) as maintenance therapy for patients with extensive‑stage SCLC who are candidates for maintenance after receiving Tecentriq and chemotherapy as initial standard‑of‑care treatment. In this study, patients receive Reqorsa plus Tecentriq until disease progression or unacceptable toxicity. Company disclosures indicate that the Phase 1 portion showed Reqorsa was generally well tolerated without dose‑limiting toxicities, and the Phase 2 expansion is focused on progression‑free survival and overall survival endpoints.

Genprex reports that each of its lung cancer clinical programs with Reqorsa has received Fast Track Designation from the U.S. Food and Drug Administration (FDA), and that its SCLC program has also received Orphan Drug Designation. The company also highlights preclinical data in ALK‑EML4‑positive NSCLC models, where Reqorsa‑mediated TUSC2 upregulation induced apoptosis in cell lines and patient‑derived organoids, including those resistant to the ALK inhibitor alectinib. In mouse xenograft studies described in Genprex‑supported presentations, Reqorsa alone and in combination with alectinib reduced tumor growth and improved survival compared with control treatment.

Diabetes gene therapy program

Beyond oncology, Genprex is developing GPX‑002, a diabetes gene therapy candidate for both Type 1 diabetes (T1D) and Type 2 diabetes (T2D). The company describes a novel infusion process that uses an adeno‑associated virus (AAV) vector to deliver the Pdx1 and MafA genes directly to the pancreas, typically via administration into the pancreatic duct. In T1D models, GPX‑002 is designed to transform pancreatic alpha cells into functional beta‑like cells that can produce insulin and may be distinct enough from native beta cells to evade autoimmune attack. In in vivo T1D mouse studies cited by Genprex, GPX‑002 restored normal blood glucose levels for extended periods, and in non‑human primate models it decreased insulin requirements, increased c‑peptide levels, and improved glucose tolerance.

In T2D, where autoimmunity is not the primary driver, GPX‑002 is described as working by rejuvenating and replenishing exhausted beta cells that produce insulin. Company‑reported preclinical studies in T2D mouse and non‑human primate models have shown improved glucose tolerance, normalization of glucose levels in mice, and evidence of beta‑cell functional recovery. Genprex has outlined steps such as technology transfer of GPX‑002 manufacturing to contract development and manufacturing organizations (CDMOs), planning for cGMP‑compliant clinical‑scale production, regulatory interactions related to IND‑enabling toxicology studies, and evaluation of a second‑generation non‑viral lipid nanoparticle delivery approach.

Technology platforms and collaborations

Genprex’s disclosures emphasize its work with academic and clinical collaborators, including MD Anderson Cancer Center for oncology research and biomarker discovery, and research partners for diabetes studies in animal models. The Oncoprex Delivery System is central to the oncology platform, using positively charged lipid‑based nanoparticles to preferentially target negatively charged cancer cells and deliver the TUSC2 gene. Laboratory studies referenced by the company report substantially higher TUSC2 uptake in tumor cells compared with normal cells after Reqorsa treatment.

For diabetes, the AAV‑based delivery of Pdx1 and MafA genes directly to the pancreas underpins GPX‑002’s mechanism. Genprex describes both intraductal infusion and direct pancreatic injection approaches in preclinical work, along with the role of temporary immunosuppression in non‑human primate studies to manage immune responses to AAV constructs.

Regulatory and capital markets context

Genprex’s common stock trades on the Nasdaq Capital Market under the symbol GNPX. The company has characterized itself in SEC filings as a non‑accelerated filer and smaller reporting company. Recent registration statements and prospectus supplements describe the use of at‑the‑market offerings, registered direct offerings, and warrant‑based financings to fund operations, with stated uses of proceeds including working capital and general corporate purposes.

Nasdaq‑related filings indicate that Genprex has addressed minimum bid price and stockholders’ equity listing requirements through actions such as a reverse stock split and capital raising transactions. A Nasdaq Hearings Panel granted the company time‑limited exceptions to demonstrate compliance with these continued listing standards, and Genprex has disclosed that additional financings may be needed to support its equity position.

Intellectual property

Genprex reports a growing patent estate around Reqorsa combinations with immune checkpoint inhibitors. U.S. patents cover the use of Reqorsa with PD‑L1 antibodies such as Tecentriq, and the company has noted patent protection in the U.S. and Korea for such combinations, with additional applications pursued in other jurisdictions. The European Patent Office has communicated its intent to grant a patent for Reqorsa in combination with PD‑1 antibodies for cancer treatment, adding to previously granted patents in multiple countries. These patents are described as providing exclusivity for specific Reqorsa‑checkpoint inhibitor combinations in the treatment of cancer.

Business model focus

Based on its public statements, Genprex’s business model centers on advancing gene therapy candidates through preclinical and clinical development, supported by collaborations with research institutions and contract manufacturers. Revenue‑generating commercial products are not described in the provided materials; instead, the emphasis is on clinical trial progress, regulatory designations, intellectual property, and financing activities that enable ongoing development of Reqorsa and GPX‑002.

FAQs about Genprex, Inc. (GNPX)

• What does Genprex, Inc. do?
  Genprex is a clinical‑stage gene therapy company developing gene‑based treatments for cancer and diabetes. Its programs use delivery systems to introduce therapeutic genes into target cells, with a focus on lung cancer and insulin‑producing cells in the pancreas.
• What are Genprex’s main product candidates?
  The company’s lead oncology candidate is Reqorsa Gene Therapy (quaratusugene ozeplasmid) for NSCLC and SCLC. Its lead diabetes candidate is GPX‑002, a gene therapy being studied for Type 1 and Type 2 diabetes.
• How does Reqorsa Gene Therapy work?
  Reqorsa uses the Oncoprex Delivery System to deliver a plasmid containing the TUSC2 tumor suppressor gene in lipid‑based nanoparticles. After intravenous administration, tumor cells take up the plasmid and express TUSC2, which is intended to disrupt cancer cell metabolism and signaling, restore apoptosis pathways, and enhance immune responses.
• Which cancers is Genprex targeting with Reqorsa?
  Genprex is evaluating Reqorsa in clinical trials for non‑small cell lung cancer and small cell lung cancer, in combination with approved drugs such as Tagrisso (osimertinib) and Tecentriq (atezolizumab). Preclinical data have also been reported in ALK‑EML4‑positive NSCLC models.
• What is GPX‑002 and how is it intended to treat diabetes?
  GPX‑002 is a gene therapy candidate that uses an AAV vector to deliver Pdx1 and MafA genes directly to the pancreas. In T1D models, it is designed to convert alpha cells into beta‑like cells that produce insulin. In T2D models, it is believed to rejuvenate and replenish exhausted beta cells, improving glucose control in animal studies.
• What regulatory designations has Genprex received?
  Company disclosures state that each of Genprex’s lung cancer clinical programs with Reqorsa has received FDA Fast Track Designation, and the SCLC program has received FDA Orphan Drug Designation.
• How is Genprex funding its development programs?
  SEC filings describe the use of at‑the‑market offerings, registered direct offerings of common stock, and private placements of warrants to raise capital, with proceeds allocated to working capital and general corporate purposes.
• On which exchange does GNPX trade?
  Genprex’s common stock is listed on the Nasdaq Capital Market under the ticker symbol GNPX.
• What listing compliance issues has Genprex disclosed?
  The company has reported receiving a Nasdaq exception period to regain compliance with minimum bid price and stockholders’ equity requirements, implemented a reverse stock split, and indicated that further capital raising may be needed to support continued listing standards.
• Does Genprex have commercial products?
  In the provided materials, Genprex describes itself as a clinical‑stage company focused on developing gene therapies. The disclosures emphasize clinical trials and preclinical research rather than commercial product sales.