Genprex, Inc. 8-K Summary: Material Event

Genprex, Inc. recently announced two significant advancements for its lead gene therapy candidate, Reqorsa®, a therapy designed to deliver the TUSC2 tumor suppressor gene. These developments highlight progress in both intellectual property protection and clinical trial expansion.

1. Event Description (what happened)

First, Genprex secured patent acceptance in Australia for its innovative Reqorsa® Gene Therapy when combined with PD-L1 immune checkpoint inhibitors. This patent protects Genprex's unique approach to treating certain cancers by making cancer cells more receptive to other therapies. This builds on similar patent grants in the U.S. and Korea, strengthening Genprex's global intellectual property for this combination therapy. Genprex actively pursues similar protections in other major markets, including Europe, Canada, and China.

Second, Genprex opened a new clinical trial site at the University of Kentucky for its Acclaim-3 Phase 1/2 study. This trial evaluates the Reqorsa® + PD-L1 antibody combination for patients with extensive stage small cell lung cancer (ES-SCLC), an aggressive form of lung cancer with a poor prognosis and limited treatment options. The Phase 1 portion of this study successfully completed, demonstrating the combination's general tolerability. The current Phase 2 aims to enroll approximately 50 patients to assess its efficacy. The FDA has granted "Fast Track" and "Orphan Drug" designations for this therapy, recognizing its potential to address a serious condition with high unmet medical need and potentially expediting its development and review.

2. Event Date/Timeline

Genprex issued a press release on February 10, 2026, announcing these developments. The Australian patent was accepted on February 5, 2026.

3. Impact Assessment (who/what is affected)

These developments could impact several key stakeholders:

• Investors: This news generally signals positive progress, potentially influencing stock valuation by reducing risk for a key asset and accelerating development.
• Genprex Employees: Boosts morale and validates ongoing research and development efforts.
• Patients and Healthcare Providers: Offers renewed hope for a novel treatment option for ES-SCLC as the trial progresses.
• Competitors: May influence the strategies of other companies developing lung cancer therapies.

4. Financial Impact (if applicable)

While no immediate, quantifiable financial impact (e.g., specific revenue figures, direct costs) was disclosed for these specific events, these developments carry significant financial implications:

• Intellectual Property Value: The Australian patent significantly strengthens Genprex's intellectual property, safeguarding future revenue streams from this combination therapy in a key international market. It enhances the company's long-term asset value.
• Development Costs & Timelines: Accelerated patient enrollment due to new trial sites could reduce overall development timelines and associated costs, bringing the therapy closer to market approval and revenue.
• Market Opportunity: Success in addressing ES-SCLC, a disease with a substantial unmet medical need, represents a significant market opportunity for future revenue.
• Funding Considerations: Investors should consider Genprex's overall financial position, including its cash runway and burn rate, to understand its ability to fund ongoing R&D through commercialization.

5. Key Takeaways for Investors

These advancements mark positive progress for Genprex, offering several key considerations for investors:

• Enhanced Market Protection: The Australian patent strengthens Genprex's intellectual property globally, providing market exclusivity and protecting future revenue for Reqorsa® in combination with PD-L1 inhibitors. Genprex continues to pursue similar protections in other strategic international markets like Europe, Canada, Brazil, China, and Israel.
• Accelerated Clinical Progress & Reduced Risk: Opening new trial sites accelerates patient enrollment for the Acclaim-3 Phase 2 study, potentially bringing critical data milestones closer. The successful Phase 1 results and FDA's "Fast Track" and "Orphan Drug" designations provide external validation and help reduce risks in the development pathway.
• Addressing Unmet Medical Need: The therapy targets ES-SCLC, an aggressive cancer with limited treatment options, representing a significant market opportunity if successful.
• Future Milestones: Investors should monitor the progress of the Acclaim-3 trial, particularly the anticipated interim analysis in the second half of 2026. This analysis, after the first 25 patients complete 18 weeks of follow-up, will evaluate preliminary efficacy endpoints such as Overall Response Rate (ORR) and Progression-Frees Survival (PFS).
• Biotech Volatility & Risks: While positive, clinical-stage biotech stocks are inherently volatile. Investors should be aware of clinical trial risks (e.g., failure to meet efficacy endpoints in larger studies, unexpected safety issues, regulatory hurdles) and consider the company's overall financial health, including its cash runway, as part of their due diligence. While this news is a positive development, a comprehensive investment decision requires thorough research into the company's full pipeline, competitive landscape, management team, and financial statements.