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AUSTIN, Texas - Genprex, Inc. (NASDAQ: GNPX), a clinical-stage gene therapy company with a market capitalization of $3.28 million, announced today that its collaborators will present positive preclinical data at the 2025 American Association for Cancer Research (AACR) Annual Meeting in late April. According to InvestingPro data, the company maintains a strong cash position relative to its debt, though its overall financial health score remains challenged at 1.44 out of 5. The data pertains to the company’s lead drug candidate, Reqorsa® Gene Therapy, for the treatment of KRASG12C mutant non-small cell lung cancer (NSCLC) resistant to Ras inhibitors.
The study focuses on overcoming resistance to Lumakras® (sotorasib), the first FDA-approved KRAS inhibitor, which presents a significant challenge in treating KRASG12C mutant NSCLC. Despite initial responses, patients often develop resistance, leading to a need for alternative treatments. With the stock trading at $0.39, InvestingPro analysis suggests the company is fairly valued, with 10+ additional ProTips available to subscribers regarding the company’s financial outlook and market performance. Researchers found that TUSC2 gene therapy, delivered via Reqorsa, effectively overcomes this resistance in mouse xenografts.
The preclinical data shows that TUSC2 transfection significantly reduced colony formation and increased apoptosis in resistant cell lines. Furthermore, re-expression of TUSC2 in patient-derived xenograft organoids (PDXOs) markedly decreased their viability. While sotorasib alone showed limited efficacy in these models, the combination of REQORSA and sotorasib exhibited a synergistic antitumor effect.
Ryan Confer, President and CEO of Genprex, expressed optimism about the potential of REQORSA as a treatment for various types of cancer, highlighting the need for new therapies in lung cancer subsets with unmet medical needs.
REQORSA, which consists of a plasmid containing the TUSC2 gene encapsulated in non-viral lipid nanoparticles, is designed to target cancer cells specifically, minimizing uptake by normal tissue. Genprex’s Oncoprex® Delivery System, a systemic, non-viral method, administers gene-expressing plasmids intravenously to express tumor suppressor proteins in tumors.
Genprex is also conducting clinical trials evaluating Reqorsa for NSCLC and SCLC, with Fast Track Designations from the FDA for both lung cancer programs and an Orphan Drug Designation for the SCLC program.
The presentation of this data at the AACR meeting represents a step forward in the search for effective treatments for lung cancer patients resistant to current therapies. However, further clinical development is necessary to determine REQORSA’s efficacy and safety in humans.
This news is based on a press release statement from Genprex, Inc. Investors should note that the company’s next earnings report is scheduled for March 31, 2025, with analysts maintaining a $7.50 price target, according to InvestingPro data. For comprehensive analysis of biotechnology stocks and detailed financial metrics, consider accessing InvestingPro’s advanced stock screener and expert insights.
In other recent news, Genprex, Inc. has announced significant developments in its diabetes gene therapy program. The company has consolidated its licensing agreements with the University of Pittsburgh into a new exclusive arrangement, granting it global rights to various gene therapy technologies for Type 1 and Type 2 diabetes. These technologies aim to transform alpha cells into insulin-producing beta-like cells and rejuvenate exhausted beta cells, marking a potential shift in diabetes treatment. Genprex has also formed a new subsidiary, Convergen Biotech, Inc., to focus on advancing its diabetes initiatives separately from its oncology programs.
In collaboration with a contract development and manufacturing organization, Genprex is working on a non-viral delivery system for its diabetes gene therapy candidate, which could allow for re-dosing. The company’s preclinical studies have shown promising results in extending glucose control in Type 1 diabetes mouse models. Genprex is planning to seek FDA guidance to initiate human clinical trials by the second half of 2025. Meanwhile, Genprex faces challenges with Nasdaq compliance, having been notified of non-compliance with both the minimum bid price and stockholders’ equity requirements. The company has until August 6, 2025, to address these issues, with potential solutions including a reverse stock split.
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