Genprex, Inc. (GNPX) Bundle
When you look at the gene therapy space, how does a clinical-stage company like Genprex, Inc. (GNPX) with a market capitalization of just over $5.04 million as of November 2025, continue to drive a multi-program pipeline? The answer lies in its core mission-to conquer cancer and diabetes by delivering disease-fighting genes-and its ability to secure capital, like the recent registered direct offerings that sought to raise up to $10.0 million and $8.1 million in October 2025. This Austin-based firm is advancing its lead candidate, Reqorsa® Gene Therapy, in lung cancer trials, bolstered by a new U.S. patent granted in November 2025 that extends protection through 2037. Understanding Genprex's history, its non-viral Oncoprex® Delivery System, and its reliance on licensing revenue over product sales is crucial for assessing its true long-term value, even with total assets of only $4.12 million against $2.5 million in liabilities as of March 2025.
Genprex, Inc. (GNPX) History
You need a clear, precise history of Genprex, Inc. to understand its current valuation and future trajectory as a clinical-stage gene therapy company. The direct takeaway is that Genprex evolved from a small Austin-based startup focused on a single cancer gene therapy technology into a dual-program biotech, driving its lead candidate, REQORSA™ Gene Therapy, through late-stage trials while expanding into diabetes treatment.
Given Company's Founding Timeline
Genprex's origin story is rooted in a post-financial crisis acquisition and a deep personal commitment to finding new cancer treatments, a mission that still shapes the company today.
Year established
The company was formally co-founded in April 2009.
Original location
Genprex started in Austin, Texas, where its corporate headquarters remain today.
Founding team members
The company was co-founded by David Nance and Rodney Varner, who acquired the core REQORSA™ technology after the 2008 financial crisis. Oncologist Jack A. Roth, M.D., a pioneer in targeted cancer therapies, was integrally involved early on, providing the foundational clinical data from his work at MD Anderson Cancer Center.
Initial capital/funding
Specific initial capital figures are not publicly disclosed, but the co-founders acquired the technology from a former biotech company. The first major external capital event was the Initial Public Offering (IPO) on March 29, 2018, which listed the common stock on the Nasdaq Capital Market at $5 per share. For context, the company recently raised up to $10.0 Million in a registered direct offering announced in October 2025 to fund its ongoing clinical programs.
Given Company's Evolution Milestones
The company's history is a clear progression from technology acquisition to focused clinical development and intellectual property expansion, which is typical for a high-risk, high-reward biotech. Here's the quick math on their journey: 16 years from founding to their current clinical-stage status.
| Year | Key Event | Significance |
|---|---|---|
| 2009 | Company Co-founded and Core Technology Acquired | Established the foundation for the Oncoprex® Delivery System and REQORSA™ Gene Therapy. |
| 2018 | Acquired ReqMed and IPO on Nasdaq | Enhanced intellectual property portfolio; secured public market funding, listing at $5 per share. |
| 2020 | FDA Fast Track Designation for REQORSA™ in NSCLC | Validated the potential of REQORSA™ in combination with Osimertinib, allowing for an expedited review process. |
| 2023 | Positive Acclaim-1 Data and Acclaim-2 Trial Announcement | Demonstrated promising clinical activity in combination with chemotherapy, leading to the planning of a registration-directed trial. |
| 2024 | CEO Rodney Varner Passed Away | A major leadership transition; Ryan Confer stepped up as President and CEO to continue the founders' legacy. |
| Nov 2025 | U.S. Patent Grant for REQORSA™ Combination | Strengthened intellectual property, protecting the combination of REQORSA™ with PD-L1 antibodies (like Tecentriq) through 2037. |
Given Company's Transformative Moments
The most transformative decisions for Genprex centered on strategic focus and pipeline expansion. You can't be a clinical-stage company for long without making calculated bets on your core assets.
- Singular Focus on REQORSA™ Development: The company made a clear pivot to prioritize the clinical advancement of REQORSA™ (quaratusugene ozeplasmid) for Non-Small Cell Lung Cancer (NSCLC) and Small Cell Lung Cancer (SCLC). This focus is evidenced by the multiple FDA Fast Track Designations and an Orphan Drug Designation for the SCLC program.
- Pipeline Expansion into Diabetes: A major strategic shift was the expansion beyond oncology into Type 1 and Type 2 diabetes with the GPX-002 program. This move diversifies the risk profile, a defintely smart move for a biotech, by using a different gene therapy approach (AAV vector) to transform pancreatic cells.
- Continuous Capital and IP Strengthening: The company has consistently pursued financing, such as the October 2025 registered direct offering of up to $10.0 Million, to keep the lights on and the trials running. This is paired with an aggressive intellectual property strategy, securing patents in the US and Europe in late 2025 for its combination therapies.
The current market capitalization, which sits around $10.8 Million as of late October 2025, reflects the high-risk nature of a clinical-stage company whose value is tied entirely to future clinical success. For a deeper dive into the market's perception, you should read Exploring Genprex, Inc. (GNPX) Investor Profile: Who's Buying and Why?
The projected Earnings Per Share (EPS) for the 2025 fiscal year is expected to be -$1.28, which is common for a company investing heavily in Research and Development with no commercial revenue yet. The key action for you is to track the interim analysis data from the Acclaim-3 trial, expected after the 25th patient reaches 18 weeks of follow-up, as this will be the next major catalyst.
Genprex, Inc. (GNPX) Ownership Structure
The ownership structure of Genprex, Inc. is dominated by a high concentration of insider holdings, reflecting a significant stake held by the company's officers and directors, while it remains a publicly traded entity on the Nasdaq Capital Market.
Genprex, Inc.'s Current Status
Genprex, Inc. is a publicly traded, clinical-stage gene therapy company. Its common stock is listed on the Nasdaq Capital Market under the ticker symbol GNPX. As of November 14, 2025, the stock price was approximately $4.43 per share. This public status allows Genprex to raise capital through equity offerings, such as the registered direct offerings totaling up to $18.2 million announced in October 2025. The company's market capitalization was approximately $10.8 million as of late October 2025.
Genprex, Inc.'s Ownership Breakdown
The company's ownership is heavily weighted toward insiders, which is common for a clinical-stage biotech firm where the value is tied closely to the core team and intellectual property. This structure means the management team has a deep, vested interest in the long-term success of the gene therapy pipeline.
| Shareholder Type | Ownership, % | Notes |
|---|---|---|
| Insider Ownership | 88.37% | Includes officers, directors, and strategic individual stakeholders like Christy M. Nance, the largest individual shareholder. |
| Institutional Ownership | 11.63% | Held by 26 institutional owners, including major firms like Vanguard Group Inc. and BlackRock, Inc. |
| Retail Ownership | 0.00% | The remaining portion, often considered negligible or included in other categories due to the high insider/institutional split. |
The high insider ownership, at approximately 88.37%, gives the leadership substantial control over strategic decisions, including the advancement of their lead drug candidate, Reqorsa® Gene Therapy.
Genprex, Inc.'s Leadership
The organization is steered by a focused executive team with significant tenure in the biopharmaceutical space. The average tenure for the management team is over four years, suggesting a stable, defintely experienced core group.
- Ryan M. Confer, MS: President and Chief Executive Officer. He was appointed CEO in September 2016 and also serves as the Chief Financial Officer.
- Mark Berger, M.D.: Chief Medical Officer. Dr. Berger oversees the clinical development programs, including the Acclaim-3 clinical study of Reqorsa® in lung cancer.
- Suzanne Thornton-Jones, Ph.D.: Senior Vice President, Regulatory Affairs and Quality. She manages the critical path for regulatory compliance and submissions.
- Thomas Gallagher, Esq.: Senior Vice President of Intellectual Property & Licensing. This role is crucial for protecting the company's core asset, the Oncoprex® Delivery System.
The leadership's primary focus in the second half of the 2025 fiscal year has been on advancing clinical trials and securing intellectual property, such as the U.S. patent granted in November 2025 for Reqorsa® in combination with PD-L1 antibodies. You can dig deeper into the company's financial standing and runway by reading Breaking Down Genprex, Inc. (GNPX) Financial Health: Key Insights for Investors.
Genprex, Inc. (GNPX) Mission and Values
Genprex, Inc. is driven by a singular, life-altering goal: to conquer cancer and diabetes by developing pioneering gene therapies. This commitment goes beyond the balance sheet, centering on scientific rigor and a deep dedication to improving patient outcomes.
Genprex, Inc.'s Core Purpose
You're investing in a clinical-stage biotech, so you know the mission is everything-it's the fuel for the cash burn. For Genprex, that purpose is clearly defined across their oncology and diabetes programs, focusing on large patient populations with limited treatment options.
Official mission statement
The company's mission is to conquer cancer through transformative technologies, which is a big statement. But honestly, for a gene therapy company, that high-stakes ambition is necessary. It boils down to a few core actions:
- Develop and commercialize cutting-edge gene therapies.
- Address significant unmet needs in cancer and diabetes treatment.
- Improve the lives of patients and their families.
Here's the quick math on that commitment: the net loss for the nine months ended September 30, 2025, was a hefty $12.44 million, which shows the scale of their investment in R&D before any revenue.
Vision statement
While a formal, one-sentence vision isn't always public, the company's actions and communications clearly point to an aspirational future. They are focused on being at the forefront of medical advancements, striving to bring hope and improved outcomes to patients worldwide.
To be fair, a clinical-stage company's vision is less about market share and more about regulatory success. Their progress with Reqorsa® Gene Therapy in lung cancer, including multiple FDA Fast Track Designations, is the clearest evidence of their vision in action.
Genprex, Inc. slogan/tagline
The most concise summary of their purpose, which you'll see in investor materials, is their tagline. It cuts straight to the point of their work.
- Pioneering Gene Therapies for Patients in Need.
This is defintely a good, clean one-liner that maps their technology to an empathetic outcome. Still, the reality is that as of June 30, 2025, the company had only $1.35 million in cash and cash equivalents, so their mission relies heavily on their ability to raise capital-they secured approximately $7.77 million in net cash from financing activities in the first six months of 2025.
You can find the full details on their corporate philosophy here: Mission Statement, Vision, & Core Values of Genprex, Inc. (GNPX).
Genprex, Inc. (GNPX) How It Works
Genprex, Inc. is a clinical-stage biotechnology company that creates value by developing novel, first-in-class gene therapies for cancer and diabetes, primarily by using its proprietary systemic, non-viral delivery platform to reprogram disease-causing cells.
The company does not generate revenue from product sales yet, as its lead candidates are still in clinical trials; instead, its financial activity is dominated by research and development (R&D) expenses, resulting in a trailing 12-month net loss of approximately -$17.0M as of September 30, 2025.
Given Company's Product/Service Portfolio
| Product/Service | Target Market | Key Features |
|---|---|---|
| Reqorsa Gene Therapy (quaratusugene ozeplasmid) | Non-Small Cell Lung Cancer (NSCLC) | Systemic, non-viral delivery; restores tumor suppressor function; Phase 1/2 Acclaim-1 trial (often combined with Tagrisso). |
| Reqorsa Gene Therapy (quaratusugene ozeplasmid) | Extensive-Stage Small Cell Lung Cancer (ES-SCLC) | FDA Fast Track and Orphan Drug Designations; Phase 1/2 Acclaim-3 trial (maintenance therapy with Tecentriq). |
| GPTX-203 (Diabetes Gene Therapy) | Type 1 and Type 2 Diabetes | Preclinical stage; uses AAV vector to deliver Pdx1 and MafA genes to the pancreas; aims to improve beta-cell function. |
Given Company's Operational Framework
Genprex's operational model is focused on the high-risk, high-reward process of gene therapy development, which means spending heavily on R&D and clinical trials to achieve regulatory approval for its pipeline candidates.
The core of their operation is the Oncoprex Delivery System (a lipoplex, or lipid-based nanoparticle delivery system), which allows the therapeutic gene to be administered intravenously, unlike many gene therapies that require direct injection into a tumor or organ. This makes the treatment systemic, a defintely big advantage for widespread cancers.
Here's the quick math on their burn rate: The reported Q3 2025 net loss was -$3.8M, which is the cost of running clinical trials, research, and general administration. To fund this, the company relies on capital raises, such as the October 2025 direct offerings totaling up to $18.2 Million in potential gross proceeds.
- Drug Development: Design gene-expressing plasmids for specific therapeutic targets, like the tumor suppressor gene TUSC2 in Reqorsa.
- Manufacturing: Produce the gene-expressing plasmids and encapsulate them in the non-viral Oncoprex lipid nanoparticles (lipoplex).
- Clinical Trials: Conduct multi-site trials, like the recent addition of a new site for the Acclaim-1 and Acclaim-3 trials in November 2025, to expedite patient enrollment.
- Regulatory Milestones: Advance programs toward key endpoints; for instance, the Acclaim-3 trial is targeting interim analysis after the enrollment of 25 patients in the first half of 2026.
For more on the capital structure supporting this R&D, you should check out Exploring Genprex, Inc. (GNPX) Investor Profile: Who's Buying and Why?
Given Company's Strategic Advantages
Genprex's competitive edge is rooted in its technology platform and the regulatory momentum it has built around its lead product.
- Systemic Non-Viral Delivery: The Oncoprex Delivery System is a non-viral platform, which often means lower immunogenicity risk and easier large-scale manufacturing compared to traditional viral vector-based gene therapies.
- Intellectual Property Protection: A U.S. patent was granted in November 2025 for Reqorsa in combination with PD-L1 antibodies, securing exclusivity for this cancer treatment combination through 2037.
- Expedited Regulatory Pathway: Both lung cancer programs (Acclaim-1 and Acclaim-3) hold FDA Fast Track Designation, which is designed to speed up the development and review of drugs for serious conditions that fill an unmet medical need.
- Orphan Drug Status: The SCLC program (Acclaim-3) also has FDA Orphan Drug Designation, providing seven years of market exclusivity upon approval, plus tax credits and waived fees.
These designations are critical because they signal the FDA's recognition of the high unmet need in these lung cancer patient populations, and they can cut years off the typical drug development timeline. The company's current market capitalization is small at only $10.8M as of October 2025, so any positive clinical data could trigger a huge inflection point.
Genprex, Inc. (GNPX) How It Makes Money
Genprex, Inc. is a clinical-stage gene therapy company, so it defintely doesn't make money by selling a product yet. Instead, the company funds its extensive research and clinical trials, primarily for its lead cancer therapy, REQORSA, through financing activities-selling stock-and securing strategic collaborations and grants to advance its pipeline.
Given Company's Revenue Breakdown
As a pre-commercial biotech firm, Genprex's revenue from product sales is nonexistent. The company's reported revenue is negligible or zero, and any income is non-recurring, tied to research agreements or grants. This table reflects the reality of a company in the Phase 2 clinical trial stage, where product revenue is still years away.
| Revenue Stream | % of Total | Growth Trend |
|---|---|---|
| Product Sales (REQORSA, GPX-002) | 0% | Stable (at zero) |
| Collaboration/Grant Income | 100% | Highly Volatile/Near Zero |
Business Economics
The economics of Genprex are entirely driven by its research and development (R&D) burn rate, not sales. This is a classic 'cash-to-milestone' model common in early-stage biotech, where value is created by hitting clinical trial endpoints, not by generating revenue. The key economic fundamental here is the cash runway-how long the company can operate before it needs to raise more capital.
- Pricing Strategy: There is no current pricing strategy for its lead candidate, REQORSA (quaratusugene ozeplasmid), or the diabetes therapy GPX-002, because they are not approved for sale. Future pricing will be a premium, specialty drug price, reflecting the high cost of gene therapy development and the value of treating drug-resistant cancers.
- Cost Structure: The cost of goods sold (COGS) is effectively zero, but R&D expenses are the primary cost. For the third quarter of 2025, operating expenses were approximately $3.35 million. This expense is almost entirely dedicated to funding clinical trials like Acclaim-1 and Acclaim-3.
- Capital Dependence: The business is completely dependent on external funding. The company has actively raised capital, including through equity offerings, which leads to shareholder dilution. Honestly, this is the main source of cash, not revenue.
Given Company's Financial Performance
Looking at the Q3 2025 results, the financial health indicators are typical for a development-stage company: deep in the red but managing the burn rate. The focus isn't on profit; it's on extending the cash runway to reach the next data readout. Exploring Genprex, Inc. (GNPX) Investor Profile: Who's Buying and Why?
- Net Loss: For the nine months ended September 30, 2025, the company reported a net loss of $12.44 million. This is a slight improvement from the prior year's period, but it's still a significant outflow.
- Loss Per Share (LPS): The basic loss per share for Q3 2025 was $5.00, which actually beat analyst consensus estimates of -$12.50, showing a better-than-expected expense control.
- Cash Position: As of September 30, 2025, cash and cash equivalents stood at only $1,103,315. This is a critically low figure.
- Cash Burn: Operating cash outflow for the first nine months of 2025 was $11.21 million. Here's the quick math: with only $1.1 million in cash, and a quarterly burn of around $3.8 million, the company's cash runway is extremely short.
- Going Concern Risk: Management has explicitly stated that current cash is only sufficient to fund operations into March 2026 and has disclosed 'substantial doubt about continuing as a going concern' without securing more financing. This is the single most important financial metric to watch.
Genprex, Inc. (GNPX) Market Position & Future Outlook
Genprex, Inc. is a high-risk, high-reward clinical-stage biotech, currently positioned at the forefront of non-viral gene therapy for difficult-to-treat cancers and diabetes, but with a micro-cap valuation of just $5.04 million as of November 2025. The company's immediate future hinges entirely on positive interim data from its Phase 2 lung cancer trials, which could provide the necessary validation to move from a cash-burning R&D firm to a viable commercial partner.
The core of its value is the lead product candidate, Reqorsa® Gene Therapy, which is in two Phase 1/2 lung cancer trials, Acclaim-1 and Acclaim-3, both holding a coveted FDA Fast Track Designation. Honestly, for a company this size, that regulatory status is a huge competitive edge.
Competitive Landscape
In the gene therapy space, Genprex's systemic, non-viral approach sets it apart from the dominant viral vector and T-cell therapies, but it means their market share is currently 0% as a pre-revenue company. You need to compare them against both a direct, smaller competitor and a major, established player to understand the scale of the challenge.
| Company | Market Share, % | Key Advantage |
|---|---|---|
| Genprex, Inc. | 0% | Systemic, Non-Viral Oncoprex® Delivery System for broad tumor targeting. |
| Adaptimmune Therapeutics | <1% (Solid Tumor Cell Therapy) | Commercial-stage autologous T-cell therapy (TECELRA) for solid tumors. |
| Vertex Pharmaceuticals | Significant (Multi-Billion Revenue) | Established revenue base in Cystic Fibrosis and commercialized CRISPR-based gene editing (CASGEVY). |
Opportunities & Challenges
The near-term trajectory is defined by clinical milestones and the constant need for capital. The forecasted annual Earnings Before Interest and Taxes (EBIT) for the 2025 fiscal year is expected to be -$35 million, so cash runway is the single most important metric you should track.
| Opportunities | Risks |
|---|---|
| Positive interim data from Acclaim-1/Acclaim-3 trials in H1 2026. | High cash burn rate with forecasted 2025 EBIT of -$35 million. |
| Expanding intellectual property with new U.S. patent for Reqorsa® combination therapy through 2037. | Significant stock price decline (down 94% over the past year) and high volatility. |
| Pipeline expansion into new indications like ALK-positive NSCLC and glioblastoma based on 2025 preclinical data. | Further shareholder dilution from registered direct offerings, like the recent one for up to $10.0 million. |
| Advancing the novel, preclinical GPX-002 diabetes gene therapy program. | Reliance on third-party Contract Development and Manufacturing Organizations (CDMOs) and Clinical Research Organizations (CROs). |
Industry Position
Genprex is a micro-cap player in the massive global gene therapy market, which is expected to grow from $10.4 billion in 2025 to over $51 billion by 2034. It occupies a niche within the oncology segment, which accounted for a 41.3% market share in 2024.
- Niche Focus: The company's non-viral delivery system, Oncoprex®, is a key differentiator in a market dominated by viral vectors, offering a potential advantage in manufacturing and safety.
- Regulatory Advantage: Fast Track and Orphan Drug designations for its lung cancer programs position it for potentially expedited review, which is defintely critical for a small company.
- Financial Constraint: The company's market capitalization of just $5.04 million and its pre-revenue status mean it faces severe liquidity risk and ongoing dilution, unlike larger commercial-stage peers.
- Strategic Path: The strategy is clear: focus resources on the most promising clinical trials (Acclaim-1 and Acclaim-3) to generate a breakthrough that can attract a major partner or institutional funding.
For a detailed look at the balance sheet risks, you should read Breaking Down Genprex, Inc. (GNPX) Financial Health: Key Insights for Investors.
Here's the quick math: with a market cap this low, any positive clinical data could lead to a multi-fold return, but one clinical setback could wipe out most of the remaining value.
Next Step: Analyst Team: Model the impact of a 50% increase in patient enrollment costs on the current cash runway by Friday.

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