Genprex Announces Registered Direct Offering of up to $8.1 Million Priced At-The-Market Under Nasdaq Rules
Funding Announcement: Genprex, Inc. has entered into agreements to issue and sell 243,622 shares of common stock at $11.21 per share, aiming for gross proceeds of approximately $2.7 million, with potential additional proceeds of $5.4 million from short-term warrants.
Use of Proceeds: The company plans to utilize the net proceeds from this offering for working capital and general corporate purposes, with the closing expected around October 24, 2025, pending customary conditions.
Company Overview: Genprex is a clinical-stage gene therapy company focused on developing therapies for cancer and diabetes, utilizing innovative technologies like the Oncoprex® Delivery System and its lead product candidate, Reqorsa® Gene Therapy.
Regulatory Compliance: The shares are being offered under a "shelf" registration statement, while the unregistered warrants are part of a private placement and are not registered under the Securities Act, limiting their sale in the U.S. without proper registration.
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- Market Size Forecast: The EGFR-NSCLC market is projected to reach $6 billion by 2024, with the U.S. accounting for approximately 56% of the total market, indicating strong demand for new therapies and significant economic potential in this region.
- Rising Patient Numbers: In 2024, nearly 117,000 new cases of EGFR-NSCLC are expected, and as testing rates increase, more patients with EGFR mutations are identified, driving the demand for targeted therapies and signaling ongoing market expansion.
- Active Drug Development: Several new drugs, including Zipalertinib and Firmonertinib, are in clinical trials and are anticipated to introduce new treatment options, which not only diversify the therapeutic landscape but also have the potential to redefine existing treatment standards and improve patient survival rates.
- Evolving Competitive Landscape: The convergence of TKIs, ADCs, and gene therapies is intensifying competition in the EGFR-NSCLC market, where future winners will depend on efficacy, resistance coverage, and combination therapy potential, driving innovation and growth in the industry.
- Investment Activity: Congressman Tim Moore made multiple purchases of shares in the gene therapy company Genprex (market cap under $5 million) in 2025, totaling between $31,000 and $115,000, indicating a keen interest in high-risk small-cap investments.
- Trading Performance: Moore was recognized as the top-performing member of Congress for stock trades in 2025, achieving a 52% return, significantly outperforming the S&P 500's 16.6% gain, which underscores the effectiveness of his investment strategy.
- Company Developments: Genprex experienced notable volatility in 2025, particularly in October when its stock surged following an update on its lead drug candidate REQORSA, highlighting market interest in its research progress.
- Future Outlook: Genprex plans to meet with the FDA to request Investigational New Drug studies, which could pave the way for human clinical trials, necessitating investor attention to the high volatility associated with its clinical data releases.
- Clinical Progress: Genprex has reported encouraging early results from preclinical tests in mice and non-human primates, indicating that GPX-002 rejuvenates beta cells and normalizes glucose levels, marking a potential breakthrough in diabetes treatment.
- Manufacturing Transition: The company has moved the manufacturing of GPX-002 to skilled CDMO partners to enhance production capacity and optimize delivery methods, preparing for future human clinical trials and demonstrating a commitment to product quality and efficiency.
- FDA Meeting Plans: Genprex is seeking to meet with the FDA to discuss studies needed for an IND application, indicating a proactive approach in advancing clinical trials and a focus on regulatory compliance to expedite product market entry.
- Increased Research Investment: In 2025, the company plans to ramp up research efforts for Type 2 diabetes and initiate toxicology studies, further driving clinical trial advancements and showcasing its long-term commitment and strategic positioning in the diabetes treatment market.
- Clinical Progress: In 2025, Genprex successfully initiated preclinical research for GPX-002 targeting Type 2 diabetes, marking a significant milestone in its diabetes gene therapy program and laying the groundwork for future human clinical trials.
- Production Transfer: The company has transferred the production of GPX-002 to an experienced Contract Development and Manufacturing Organization (CDMO), which is expected to enhance production efficiency and accelerate the clinical development process.
- FDA Meeting Request: Genprex submitted a request to the FDA for a meeting regarding its Investigational New Drug (IND)-enabling studies, a crucial step that will provide necessary regulatory support for the smooth advancement of its clinical trials.
- Technological Innovation: GPX-002 demonstrates the ability to convert pancreatic alpha cells into functional beta-like cells, showing potential to restore normal blood glucose levels in Type 1 diabetes models, indicating a promising breakthrough in diabetes treatment.
- Research Expansion: Genprex has successfully initiated preclinical studies in Type 2 diabetes animal models, marking a significant milestone in its diabetes gene therapy program, which is expected to enhance the evaluation capabilities of GPX-002 in relevant disease models, thereby accelerating product development.
- Regulatory Engagement: The company plans to submit a meeting request to the FDA by the end of 2025 to discuss IND-enabling preclinical studies, with the meeting scheduled for the first quarter of 2026, which will lay the groundwork for potential human clinical trials and is strategically significant.
- Technology Transfer: Genprex has successfully transferred the production of GPX-002 to an experienced Contract Development and Manufacturing Organization (CDMO), a move that will accelerate manufacturing processes and ensure compliance with cGMP standards, preparing the company for clinical trials.
- Product Optimization: The company is collaborating with CDMOs and research partners to optimize constructs and evaluate a second-generation alternative using a non-viral lipid nanoparticle delivery system, aiming to enhance therapeutic efficacy and safety.
- Therapy Efficacy: Genprex's diabetes gene therapy GPX-002 has shown positive preliminary results in non-human primates and mice, indicating its potential to improve insulin secretion by rejuvenating exhausted beta cells, thus offering a new treatment option for Type 2 diabetes patients.
- Innovative Delivery Method: In the non-human primate study, administering GPX-002 via intraductal infusion led to steady improvements in glucose tolerance over several months, with normal glucose tolerance achieved by seven months, suggesting this method may more effectively target alpha and beta cells.
- Mouse Study Results: In Type 2 diabetic mice, GPX-002 produced strong activity signals, with glucose levels returning to normal four weeks post-treatment, further supporting the therapy's ability to restore functional beta cells and potentially addressing a larger population of diabetes patients.
- Future Research Plans: Genprex is continuing non-human primate studies and preparing for formal toxicology studies to support a future Investigational New Drug submission, demonstrating the company's ongoing commitment and potential in the diabetes treatment field.








