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Genprex, Inc. (GNPX): Business Model Canvas [Dec-2025 Updated] |
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You're looking at a clinical-stage biotech like Genprex, Inc., so you know the balance sheet is secondary; the real value is locked up in the pipeline and the patents protecting it. Honestly, as an analyst who's tracked these firms for years, the near-term focus is entirely on hitting those critical clinical milestones for their lead candidate, REQORSA® Gene Therapy. To keep the lights on while they chase those breakthroughs, Genprex, Inc. is operating on capital-their Q2 2025 operating expenses totaled $4.68 million, which they recently supplemented by raising up to $10.0 million in October 2025. This Business Model Canvas lays out the entire structure, from their proprietary delivery system to the specific patient segments they are targeting, so you can see the full strategic picture before making any decisions.
Genprex, Inc. (GNPX) - Canvas Business Model: Key Partnerships
You're looking at the network of external entities Genprex, Inc. relies on to execute its strategy, which is crucial given its clinical-stage focus. These relationships de-risk development and provide access to specialized expertise and infrastructure.
Academic institutions for sponsored research form a bedrock of Genprex, Inc.'s preclinical pipeline advancement, especially for its diabetes program, GPX-002. The Company entered a new Sponsored Research Agreement (SRA) with the University of Pittsburgh (Pitt) in May 2025, continuing work from a prior two-year SRA to study GPX-002 in animal models for Type 1 and Type 2 diabetes. Furthermore, Genprex, Inc. has expanded its intellectual property through exclusive license agreements with academic centers for its REQORSA gene therapy.
These academic collaborations include:
- Exclusive license with New York University Langone Health for REQORSA as a potential treatment for mesothelioma.
- Exclusive license with UTHealth Houston for REQORSA as a potential treatment for glioblastoma.
- Research collaborators at MD Anderson presented positive preclinical data for REQORSA in KRASG12C mutant NSCLC at the 2025 AACR annual meeting.
The Company also works with world-class institutions, as evidenced by research collaborators presenting data at the 2025 AACR-NCI-EORTC International Conference on Molecular Targets and Cancer Therapeutics.
Contract Development and Manufacturing Organizations (CDMOs) for product scale-up are key for next-generation development. Genprex, Inc. maintains a strategic collaboration with an unnamed CDMO to research an alternative second-generation approach for GPX-002, specifically utilizing a non-viral lipid nanoparticle delivery system for construct optimization. This work is separate from the existing preclinical research programs. The ability to scale manufacture of product candidates is explicitly cited as a key area of partnership reliance in forward-looking statements.
For clinical execution, clinical trial sites and investigators are essential for patient enrollment and data generation across the oncology program. As of November 2025, Genprex, Inc. announced the addition of a new clinical trial site to support the ongoing Acclaim-1 and Acclaim-3 clinical trials for lung cancer. These trials inherently involve partnerships with pharmaceutical companies providing combination products.
Key clinical trial partners include:
- Genentech: Supplying Tecentriq (atezolizumab) for use in the Acclaim-3 trial as maintenance therapy in extensive stage small cell lung cancer (ES-SCLC).
- AstraZeneca: Supplying Tagrisso (osimertinib) for use in the Acclaim-1 trial evaluating REQORSA combination in late-stage non-small cell lung cancer (NSCLC) with EGFR mutations.
Regarding patient advocacy groups, the outline suggests a role, such as the mention of ALK Positive for preclinical study support; however, specific, confirmed partnerships or financial contributions to such groups by Genprex, Inc. as of late 2025 are not detailed in the available updates. I can only report on what is explicitly stated.
For potential future pharmaceutical partners for licensing and commercialization, the current structure shows co-development/combination use rather than outright licensing deals for commercialization as of late 2025. The Company states it is considering various strategic alternatives and opportunities to enhance stockholder value, which implies future partnership discussions are a possibility.
Here is a snapshot of the confirmed institutional and commercial partners as of late 2025:
| Partner Category | Specific Entity/Program | Nature of Relationship/Data Point |
| Academic Research (Diabetes) | University of Pittsburgh (Pitt) | New Sponsored Research Agreement (SRA) signed May 2025 for GPX-002 in T1D/T2D animal models. |
| Academic Research (Oncology IP) | New York University Langone Health | Exclusive license agreement for REQORSA in mesothelioma. |
| Academic Research (Oncology IP) | UTHealth Houston | Exclusive license agreement for REQORSA in glioblastoma (additional technology). |
| Clinical Trial Site Network | Undisclosed Site | New site added in November 2025 for Acclaim-1 and Acclaim-3 trials. |
| Oncology Combination Partner | Genentech | Supplying Tecentriq for use in the Acclaim-3 clinical trial. |
| Oncology Combination Partner | AstraZeneca | Supplying Tagrisso for use in the Acclaim-1 clinical trial. |
| CDMO Collaboration | Unnamed CDMO | Strategic collaboration for research on second-generation GPX-002 delivery system. |
The ongoing clinical trials, Acclaim-1 and Acclaim-3, have both received U.S. Food and Drug Administration (FDA) Fast Track Designation. Additionally, the SCLC indication in Acclaim-3 has FDA Orphan Drug Designation.
Finance: draft 13-week cash view by Friday.
Genprex, Inc. (GNPX) - Canvas Business Model: Key Activities
You're managing a clinical-stage biotech, so the key activities revolve around advancing the science through trials and protecting the resulting assets. Here's the breakdown for Genprex, Inc. as of late 2025.
Research and Development (R&D) of gene therapy candidates.
The core R&D activity centers on the lead candidate, Reqorsa® Gene Therapy (quaratusugene ozeplasmid), particularly in oncology. This involves ongoing preclinical validation supporting combination strategies. For instance, recent preclinical data showed a 79% tumor shrinkage in ALK-EML4 positive Non-Small Cell Lung Cancer (NSCLC) when Reqorsa was used with alectinib. This work supports the ongoing clinical trials.
Clinical trial management (Acclaim-1, Acclaim-3) for lung cancer.
Managing the Acclaim clinical program is a major operational focus, involving site expansion and data milestones. You are actively adding sites to expedite enrollment; for example, Gabrail Cancer Center in Canton, Ohio, was added as a new site on November 19, 2025, supporting both trials. The focus is on hitting interim analysis targets to maintain momentum.
Here are the key trial management metrics and targets:
| Trial | Phase/Portion | Key Combination Partner | Interim Analysis Trigger | Data Publication/Presentation |
| Acclaim-1 | Phase 2a Expansion | Tagrisso® (osimertinib) | Treatment of 19 patients | Phase 1 data published November 24, 2025 |
| Acclaim-3 | Phase 2 Expansion | Tecentriq® (atezolizumab) | Enrollment of 25th patient reaching 18 weeks follow-up | Expected enrollment completion during the second half of 2025 |
The Phase 2a expansion for Acclaim-1 is designed to enroll approximately 33 patients to evaluate safety and efficacy.
Securing and defending intellectual property (IP) and patents.
Protecting the combination therapies is critical for future commercial rights. Genprex, Inc. has been highly active in securing patent coverage for Reqorsa in combination with immune checkpoint inhibitors. This activity directly supports the ongoing Acclaim-3 trial.
Recent IP milestones include:
- U.S. Patent granted November 18, 2025, covering Reqorsa in combination with PD-L1 antibodies through 2037.
- European Patent Office announced intent to grant a patent (November 4, 2025) for Reqorsa in combination with PD-1 antibodies.
- U.S. Patent and Trademark Office issued a Notice of Allowance on August 18, 2025, for patents covering combinations with both PD-L1 and PD-1 antibodies.
Regulatory filings and maintenance of FDA Fast Track/Orphan Drug designations.
Maintaining and leveraging existing regulatory advantages is a key activity to potentially speed up development timelines. You are operating under specific FDA incentives for your lead programs.
The regulatory status includes:
- Acclaim-1 treatment combination has FDA Fast Track Designation.
- The Small Cell Lung Cancer (SCLC) program, which includes Acclaim-3, has both FDA Fast Track Designation and FDA Orphan Drug Designation.
Continuous equity financing to fund operations.
Given the cash burn associated with late-stage clinical trials, securing non-dilutive and dilutive capital is a constant, necessary activity. You need cash to keep the trial sites open and pay for manufacturing and regulatory work. The company executed several financing rounds in 2025 to maintain working capital.
Financing activity in 2025 included:
- A June 11, 2025, agreement for a $12.5 million commitment from Lincoln Park Capital Fund.
- An October 2025 registered direct offering that secured upfront gross proceeds of $2.7 million, with potential for an additional $5.4 million upon warrant exercise.
- Another October 2025 offering that raised upfront gross proceeds of approximately $3.4 million, with up to an additional $6.6 million possible from warrant exercises.
Honestly, the constant need to raise capital means investor relations and managing the share count are as critical as the science itself.
Genprex, Inc. (GNPX) - Canvas Business Model: Key Resources
You're looking at the core assets Genprex, Inc. (GNPX) relies on to drive its clinical-stage gene therapy business. For a pre-revenue biotech, these resources are the entire value proposition, so the intellectual property and the pipeline assets are paramount.
Proprietary Oncoprex® Delivery System (non-viral, systemic lipoplex)
This is the vehicle for delivering the therapeutic payload. It is described as a systemic, non-viral method that encapsulates gene-expressing plasmids using lipid-based nanoparticles formed into a lipoplex. The resultant product is administered intravenously, designed to be taken up by tumor cells.
- Delivery mechanism: Lipid-based nanoparticles in a lipoplex form.
- Administration route: Intravenous.
REQORSA® Gene Therapy (quaratusugene ozeplasmid) for oncology
REQORSA® is Genprex, Inc.'s lead product candidate, initially focused on lung cancers. It works by delivering the TUSC2 gene, a tumor suppressor gene that is decreased in 100% of small cell lung cancers (SCLCs). The therapy is being evaluated in the Acclaim-3 Phase 1/2 clinical trial for extensive stage SCLC in combination with Tecentriq® (atezolizumab) as maintenance therapy. The historical median progression-free survival (PFS) for ES-SCLC treated with Tecentriq alone is only 2.6 months. Preclinical research in mouse models showed that combining REQORSA with the ALK inhibitor Alectinib increased apoptosis and improved treatment outcomes, reducing tumor growth by up to 79 percent compared to 60 percent with Alectinib alone. Furthermore, preclinical data suggests REQORSA® is a potential treatment for ALK-EML4 positive non-small cell lung cancer (NSCLC).
GPX-002 diabetes gene therapy platform
Genprex, Inc. is advancing GPX-002 for both Type 1 diabetes (T1D) and Type 2 diabetes (T2D), exclusively licensed from the University of Pittsburgh. The approach aims to transform alpha cells into functional beta-like cells that produce insulin. In T1D mouse models, preclinical studies showed GPX-002 restored normal blood glucose levels for an extended period of time. The program development is managed through a wholly-owned subsidiary, Convergen Biotech, Inc. The initial approach uses an adeno-associated virus (AAV) vector delivering Pdx1 and MafA genes directly into the pancreatic duct, which can be done with a routine endoscopy procedure in humans. Research is also focused on a second-generation approach using a non-viral lipid nanoparticle delivery system.
Granted US and European patents covering combination therapies
Intellectual property protection is a critical resource, especially for combination therapies. Genprex, Inc. has been actively securing protection for REQORSA® in combination with immune checkpoint inhibitors.
| Patent/Application Status | Combination Therapy | Key Territory Granted/Allowed | Earliest Expiration |
|---|---|---|---|
| Granted Patent | REQORSA® + PD-L1 antibodies (e.g., Tecentriq®) | United States, Korea | 2037 |
| Notice of Allowance | REQORSA® + PD-1 antibodies | European Patent Office (EPO) | 2037 |
| Granted Patents | REQORSA® + PD-1 antibodies | U.S., Japan, Mexico, Russia, Australia, Chile, China, Singapore | Varies, earliest 2037 |
| Applications Pursued | REQORSA® + Checkpoint Inhibitors | Europe, Canada, Brazil, China, Israel | N/A |
Specialized scientific and clinical personnel
The expertise of the team and collaborators underpins the development pipeline. Key personnel mentioned include:
- Ryan Confer, President and Chief Executive Officer.
- Thomas Gallagher, Esq., Senior Vice President of Intellectual Property and Licensing.
- Research collaborators at the University of Pittsburgh for the GPX-002 platform.
Financially, the company is operating on capital raises to fund this personnel and development, as product revenue for the 2025 fiscal year is effectively $0. The net loss for the nine months ended September 30, 2025, was $12.44 million, an improvement from $16.78 million the prior year. The projected EBIT for the 2025 fiscal year is approximately -$35 million, with a projected EPS of approximately -$1.28. To extend the cash runway, Genprex, Inc. announced a registered direct offering to raise up to $10.0 million in late 2025. As of November 18, 2025, the market capitalization stood at $5.04 million, with the stock trading at $4.04.
Genprex, Inc. (GNPX) - Canvas Business Model: Value Propositions
You're looking at the core value Genprex, Inc. (GNPX) brings to patients and the market as of late 2025. This isn't about future potential alone; it's about the tangible scientific and regulatory milestones they've achieved that define their offering right now.
The primary value proposition centers on novel, first-in-class gene therapies targeting significant unmet needs in oncology. Their lead candidate, Reqorsa® Gene Therapy (quaratusugene ozeplasmid), is being evaluated for Non-Small Cell Lung Cancer (NSCLC) and Small Cell Lung Cancer (SCLC).
The delivery mechanism itself is a key differentiator. Genprex uses its systemic, non-viral Oncoprex® Delivery System, which encapsulates gene-expressing plasmids using lipid-based nanoparticles in a lipoplex form. This system is administered intravenously, aiming for safer, targeted uptake by tumor cells.
The regulatory environment validates this approach. Each of Genprex's lung cancer clinical programs has secured an FDA Fast Track Designation for its respective patient population. Furthermore, the SCLC program has an additional FDA Orphan Drug Designation.
The potential market impact is broad, addressing both oncology and metabolic disease. The company is addressing large, unmet needs in NSCLC and SCLC, alongside its preclinical work in diabetes. The diabetes candidate, GPX-002, offers the potential to transform alpha cells into insulin-producing beta-like cells for Type 1 diabetes (T1D).
Here's a snapshot of the current development status underpinning these propositions:
| Program Area | Candidate/Platform | Key Status/Data Point (as of late 2025) | Regulatory Status |
|---|---|---|---|
| Oncology (NSCLC/SCLC) | Reqorsa® Gene Therapy (quaratusugene ozeplasmid) | Preclinical data showed a 79% tumor shrinkage in ALK-EML4 positive NSCLC when used with alectinib. | Fast Track Designation for both lung cancer programs. Orphan Drug Designation for SCLC. |
| Oncology Delivery | ONCOPREX Delivery System | Systemic, non-viral platform using lipid-based nanoparticles. | N/A |
| Diabetes (T1D/T2D) | GPX-002 | Preclinical studies demonstrated sustained improved glucose homeostasis in animal models of T1D. | Preclinical stage; planned to request FDA guidance for IND-enabling studies by the second half of 2025. |
The clinical timeline for the lead oncology program shows concrete near-term milestones. The Acclaim-1 Phase 2a portion began dosing in January 2024 and is expected to finish enrolling by the end of 2025. An interim analysis on 19 patients is anticipated in the first half of 2026.
Financially, the company is operating in a capital-intensive phase, which is typical for a clinical-stage biotech. As of late 2025, Genprex had a market capitalization of approximately $6.43 million or $10.8M, with 2.27 million shares outstanding. To support this development, the company secured a registered direct offering of $2.7 million in October 2025, with the potential for another $5.4 million via warrant exercises. Management has been focused on efficiency, trimming operating expenses by 52% year-on-year.
The value proposition is supported by the following strategic elements:
- Novel gene therapy approach for difficult-to-treat cancers.
- Systemic, non-viral delivery platform.
- Preclinical data showing 79% tumor shrinkage in a specific NSCLC model.
- Diabetes program (GPX-002) aiming for alpha cell reprogramming.
- Fast Track Designation for both lung cancer programs.
The company's last reported earnings date was November 14, 2025, with the fiscal year ending December 31, 2025. The stock price as of October 29, 2025, was $6.64.
Genprex, Inc. (GNPX) - Canvas Business Model: Customer Relationships
You're looking at how Genprex, Inc. manages its critical external relationships to advance its gene therapy pipeline. For a clinical-stage biotech, these aren't just contacts; they are the pathways to data, funding, and ultimately, patient access. Here's the breakdown of those key relationship pillars as of late 2025.
High-touch, specialized relationships with key opinion leaders (KOLs) and clinical investigators.
Genprex, Inc. maintains deep ties with the academic and clinical community to drive its two main programs: Reqorsa® Gene Therapy for lung cancer and its diabetes gene therapy approach. These relationships are formalized through research agreements and site activations.
- Collaboration with the University of Michigan Rogel Cancer Center via a Sponsored Research Agreement (SRA) initiated in October 2024.
- New SRA signed with the University of Pittsburgh (Pitt) to study GPX-002 in Type 1 and Type 2 diabetes models.
- The company actively adds clinical sites to support ongoing trials, adding Gabrail Cancer Center in Canton, Ohio, as a new site in November 2025 for the Acclaim-1 and Acclaim-3 trials.
The clinical trial structure dictates specific relationship goals for patient throughput:
| Trial Component | Relationship Metric/Target | Status/Target Number |
|---|---|---|
| Acclaim-1 Phase 2a Expansion | Expected Patient Enrollment Target | Approximately 33 patients |
| Acclaim-3 Phase 2 Expansion | Expected Patient Enrollment Target | Approximately 50 patients |
| Acclaim-1 Interim Analysis Completion | Target for Enrollment of First Patients | First half of 2026 (Enrollment of first 19 patients) |
Investor relations for ongoing capital raising and shareholder communication.
Sustaining clinical development requires consistent engagement with capital markets. Genprex, Inc. has been active in securing financing through various equity offerings throughout 2025.
- Announced a $12.5 million commitment from Lincoln Park Capital Fund in June 2025.
- Filed a prospectus in November 2025 to offer up to $75,000,000 in additional common stock shares under its At The Market (ATM) Offering Agreement.
- Previously sold 796,065 shares for aggregate gross proceeds of $14,796,375 under the ATM Sales Agreement.
- Announced a registered direct offering in October 2025, with gross proceeds expected around $2.7 million from the sale of 243,622 shares at $11.21 per share, plus potential proceeds of ~$5.4 million from concurrent warrants.
Direct engagement with patient advocacy groups for trial support.
Genprex, Inc. works with advocacy organizations to align research with patient needs and gain support for specific disease areas.
- Collaboration established in October 2024 with ALK Positive, a non-profit research organization, to sponsor a preclinical study on ALK-EML4 positive lung cancer.
- Research collaborators presented data on the diabetes gene therapy program at the 2025 American Diabetes Association 85th Scientific Sessions.
Regulatory bodies (FDA, EMA) for approvals and designations.
Regulatory interactions are crucial for establishing the accelerated path for its lead candidate, Reqorsa® Gene Therapy.
- Each of Genprex, Inc.'s lung cancer clinical programs has secured Fast Track Designation from the FDA.
- The FDA granted Orphan Drug Designation for Genprex, Inc.'s SCLC program.
- The Acclaim-1 treatment combination (REQORSA and Tagrisso) received Fast Track Designation from the FDA.
- The company announced the European Patent Office's intent to grant a patent for the combination of Reqorsa® Gene Therapy and PD-1 antibodies in November 2025.
Finance: review Q4 2025 ATM utilization against the $75,000,000 shelf capacity by end of day Tuesday.
Genprex, Inc. (GNPX) - Canvas Business Model: Channels
You're looking at how Genprex, Inc. gets its science and its stock in front of the right people-the doctors, the researchers, and the investors. This is all about getting the data out and keeping the lights on through capital markets.
Clinical trial sites and hospitals for drug administration and data collection
The primary channel for drug administration and data collection is the network of clinical trial sites. Genprex, Inc. actively expands this network to ensure patient access and speed up enrollment for its key programs, REQORSA in Acclaim-1 and Acclaim-3 for lung cancer. For instance, on November 19, 2025, Genprex, Inc. announced the addition of Gabrail Cancer Center in Canton, Ohio, as a new site for both the Acclaim-1 and Acclaim-3 clinical trials. The company plans to expand its clinical trial sites to increase patient reach and expedite enrollment. The Acclaim-1 trial targets non-small cell lung cancer, while Acclaim-3 addresses small cell lung cancer. Furthermore, the diabetes gene therapy, GPX-002, is being advanced through preclinical work and new sponsored research, including a new Sponsored Research Agreement with the University of Pittsburgh signed in May 2025 for animal model studies. The delivery method for GPX-002 in humans is designed to be done with a routine endoscopy procedure, suggesting a future channel through specialized gastroenterology or endocrinology centers.
Scientific publications and medical conferences (ASCO, ADA) for data dissemination
Disseminating clinical and preclinical data through peer-reviewed channels and major medical meetings is crucial for validation. Genprex, Inc. has been active in this area throughout 2025. You can see the output of their clinical work appearing in journals and presentations:
- Data from Genprex, Inc.'s Acclaim-1 Phase 1 Gene Therapy Clinical Trial was published in Clinical Lung Cancer on November 24, 2025.
- Genprex, Inc. was selected to present the trial design of the Acclaim-3 Clinical Trial at the 2025 ASCO Annual Meeting.
- Research collaborators presented positive preclinical data on the diabetes gene therapy, GPX-002, at the 2025 American Diabetes Association (ADA) 85th Scientific Session in Chicago in June 2025. The featured abstract was a Poster Presentation in the 20 Beta-Cell Replacement Category, Poster Number 1567-B.
- The company also presented at industry conferences, including the BIO 2025 International Convention in Boston, Mass., from June 16-19, 2025.
- Management participated in investor and industry conferences in September 2025, such as the H.C. Wainwright 27th Annual Global Investment Conference and the Investor Summit Group Q3 Virtual Conference.
Direct investor communications and SEC filings for capital markets
To fund these clinical channels, Genprex, Inc. relies heavily on direct engagement with the capital markets, often utilizing At-The-Market (ATM) offerings and registered direct offerings. This requires constant communication via SEC filings. Here's a snapshot of their capital market activity and status as of late 2025:
| Financial/Capital Market Event or Metric | Amount/Value/Date | Source/Context |
| Maximum Potential Offering Size (Nov 2025) | Up to $75,000,000 | Prospectus filed November 21, 2025, under ATM program. |
| Previous Share Sale Proceeds (Prior to Nov 2025) | $14,796,375 | Gross proceeds from the sale of 796,065 shares. |
| Lincoln Park Capital Commitment (June 2025) | $12.5 million | Commitment for purchasing common stock announced June 11, 2025. |
| October 2025 Registered Direct Offering Shares Issued | 243,622 shares | Issued at a purchase price of $11.21 per share on October 24, 2025. |
| Registered Direct Offering Announced (Oct 2025) | Up to $10.0 million | Announced on October 28, 2025. |
| Shares Outstanding (as of Nov 19, 2025) | 2,318,894 | Reported in an S-1 filing. |
| Nasdaq Equity Compliance Exception Deadline | December 31, 2025 | Deadline to demonstrate long-term compliance with the Stockholders' Equity Requirement. |
The company regained compliance with the minimum bid price requirement as of November 25, 2025, but the equity requirement remains on an exception basis. Honestly, managing this cash flow through frequent equity raises is a key channel for survival right now.
Future distribution via pharmaceutical licensing partners
While Genprex, Inc. currently manages its clinical development, the long-term distribution channel for commercial success is expected to involve strategic partnerships. The company explicitly works with world-class institutions and collaborators to develop its pipeline. A significant move signaling this future channel strategy was the September 2024 announcement of the intention to spin off the diabetes program (GPX-002) into a new subsidiary, 'NewCo.' This separation was designed to enhance focus and expedite development, potentially enabling direct investment and strategic collaboration or licensing for the diabetes asset. Thomas Gallagher, Senior Vice President of Intellectual Property and Licensing, was available for one-on-one meetings at the BIO 2025 International Convention to discuss these gene therapies, suggesting active scouting for such future partners. The company's oncology program, utilizing REQORSA, is also being advanced with the expectation of future commercialization pathways, which often involve licensing deals in specific territories or indications.
Finance: draft 13-week cash view by Friday.
Genprex, Inc. (GNPX) - Canvas Business Model: Customer Segments
You're looking at the patient and physician populations that Genprex, Inc. (GNPX) targets with its gene therapy platform, Reqorsa® and GPX-002. It's a dense landscape, especially given the company's TTM Net Income of -21.39M USD as of late 2025.
Patients with Non-Small Cell Lung Cancer (NSCLC) who have progressed on standard therapy.
This segment includes patients with advanced NSCLC, particularly those with EGFR mutations who have exhausted prior lines of therapy. For instance, in the EGFR-mutated advanced NSCLC space, only about half of patients proceed to receive any second-line therapy after progression on first-line osimertinib, creating a significant unmet need for subsequent treatments like Reqorsa®.
For ALK-positive NSCLC, Genprex, Inc. is specifically researching combinations with ALK-inhibitors, targeting a niche within the broader NSCLC market.
Patients with Extensive Stage Small Cell Lung Cancer (ES-SCLC).
Genprex, Inc.'s SCLC program has received FDA Orphan Drug Designation, focusing on a highly aggressive patient group. Nearly 60-70% of all Small Cell Lung Cancer patients present with this extensive-stage disease at diagnosis.
The company's Acclaim-1 trial is specifically enrolling ES-SCLC patients who have progressed on Tagrisso-containing regimens. The Phase 2a expansion cohort is expected to enroll approximately 33 patients.
A retrospective study identified 2,025 adult ES-SCLC patients initiating first-line treatment between January 2020 and December 2023, of whom 40% received second-line treatment and 13% received third-line treatment, showing the pool of patients needing novel options.
Patients with Type 1 and Type 2 Diabetes (T1D, T2D) with limited treatment options.
Genprex, Inc. is developing GPX-002 for both Type 1 and Type 2 Diabetes, aiming to restore pancreatic function. The scale of the diabetes population in the U.S. is substantial:
- Total diagnosed diabetes in U.S. adults (18+): 29.4 million.
- Type 2 Diabetes (T2DM) accounts for 90% to 95% of all U.S. diabetes cases.
- Type 1 Diabetes (T1D) in U.S. adults (20+): Approximately 1.7 million.
- Type 1 Diabetes (T1D) in U.S. youth (under 20): 304,000 cases.
Oncologists and endocrinologists seeking novel therapeutic options.
The prescribers and key opinion leaders for these patient populations represent a critical segment for adoption. The numbers for these specialists are as follows:
| Specialist Type | Approximate Number in U.S. (Late 2025) | Relevant Context/Data Point |
|---|---|---|
| Oncologists (Total Tracked) | Over 28,000 | Demand for oncologists is projected to grow by 40% from 2012 to 2025. |
| Hematology/Oncology Specialists | 11,937 | This is the most common tracked oncology specialty. |
| Medical Oncology Specialists | 4,778 | A key group for NSCLC and SCLC treatment decisions. |
| Endocrinologists (Total) | 10,661 | As of November 28, 2025. |
| Endocrinologists (Actively Treating Diabetes) | Just over 8,000 | It is estimated there is a ratio of one endocrinologist to every 5,000 people with diabetes. |
Honestly, you see the concentration issue right away; 70% of U.S. counties have no endocrinologist, which means Genprex, Inc.'s diabetes approach, if successful, could be highly attractive to the specialists who do practice, as they manage a disproportionately large patient load.
Genprex, Inc. (GNPX) - Canvas Business Model: Cost Structure
You're analyzing the cost base for Genprex, Inc. (GNPX) as it pushes its gene therapy platform through late-stage clinical development. For a clinical-stage biotech, the cost structure is overwhelmingly weighted toward research and development, which is the engine funding the pipeline.
The dominant cost driver is clearly Research & Development (R&D) expenses, which directly fund the ongoing Acclaim-1 and Acclaim-3 clinical trials for REQORSA. For the second quarter of 2025, the reported R&D expense was $2.50 million. This expense category absorbs the majority of the cash burn required to advance the lead candidate.
The total operating cost for the period reflects this heavy investment. Total operating expenses for Q2 2025 were reported at $4.68 million. This figure encapsulates the R&D spend along with the necessary overhead to support those trials.
The remaining costs fall under General and Administrative (G&A) and third-party vendor expenses. Genprex, Inc. explicitly relies on external partners, such as contract development and manufacturing organizations (CDMOs) and contract research organizations (CROs), for scaling up clinical production and executing trials. Furthermore, legal and patent costs are a constant in this sector, especially following recent patent grants in late 2025 for the Reqorsa® combination therapy.
Here is a look at the key components of the cost structure based on the Q2 2025 figures:
| Cost Component | Q2 2025 Amount (USD) |
| Dominant R&D Expenses | $2,500,000 |
| General & Administrative (G&A) Overhead (Including Legal/Patent) | To be determined from remainder |
| Manufacturing & Third-Party Vendor Expenses (CRO/CDMO) | To be determined from remainder |
| Total Operating Expenses | $4,680,000 |
The non-R&D operating costs, which include G&A and vendor expenses, must account for the difference between the total operating expense and the reported R&D figure. This remaining amount, $2.18 million, covers the essential infrastructure to run the business and manage external partnerships.
You should track these specific cost elements closely, as they represent the operational efficiency outside of the core drug development:
- R&D expenses were $2.50 million for Q2 2025.
- Total operating expenses for Q2 2025 were $4,680,000.
- The company maintains partnerships with third-party vendors for clinical production scale-up.
- Legal and patent protection costs are ongoing, evidenced by recent patent activity in late 2025.
- The net loss for the nine months ended September 30, 2025, was $12.44 million, showing a reduction trend.
Finance: draft 13-week cash view by Friday.
Genprex, Inc. (GNPX) - Canvas Business Model: Revenue Streams
You're looking at Genprex, Inc. (GNPX) and trying to map out where the money comes from. Honestly, for a clinical-stage gene therapy company like this, the revenue stream section of the Business Model Canvas is almost entirely about capital formation, not product sales, at least as of late 2025.
The most direct takeaway for the 2025 fiscal year is that Genprex, Inc. is still firmly in the pre-revenue stage. For the trailing twelve months (TTM) ending September 30, 2025, Genprex, Inc. reported $0.0 in total revenue. This means revenue from product sales is effectively $0 for the 2025 fiscal year. This is defintely standard for a company focused solely on Research and Development (R&D) and clinical progression.
The primary cash source keeping the lights on and funding the clinical trials is equity financing. The company is actively tapping capital markets to fund its operations, which saw an operating cash outflow of $11.21 million for the nine months ended September 30, 2025. Here's the quick math on the financing activity seen in late 2025:
- Financing activities generated approximately $7.77 million in net cash for the six months ended June 30, 2025.
- The company raised $10.71 million through equity offerings in 2025 up to the Q3 report.
- In June 2025, Genprex, Inc. secured a $12.5 million commitment from Lincoln Park Capital Fund.
- Around October 2025, Genprex, Inc. announced a registered direct offering and concurrent private placement that could potentially raise up to $10.0 million in gross proceeds if all warrants are fully exercised on a cash basis.
This reliance on external capital is the current reality of the business model, as shown by the cash position as of September 30, 2025, which stood at only $1.10 million. The company carries a 'going concern' disclosure, underscoring this dependency.
Potential future revenue streams are entirely contingent on clinical success, which is where the long-term value proposition lies. These streams are not generating cash now but are the ultimate goal:
Future revenue is anticipated from:
- Milestone payments tied to clinical trial progression (e.g., completion of Acclaim-1 or Acclaim-3).
- Licensing agreements for its lead candidate, Reqorsa® Gene Therapy, or its diabetes gene therapy, GPX-002.
- Royalties from future commercial sales post-regulatory approval.
Grants and sponsored research income remain minimal or non-existent as a direct revenue line in the TTM period, though the activity confirms the stream's existence. Genprex, Inc. has engaged in agreements that represent future collaboration or research support, rather than immediate cash inflow:
| Research/Grant Activity | Date Announced | Focus Area |
| New Sponsored Research Agreement (SRA) | May 7, 2025 | GPX-002 for Type 1 and Type 2 Diabetes (with University of Pittsburgh) |
| Sponsored Research Agreement (SRA) | October 2024 | REQORSA in combination with ALK-inhibitors (with University of Michigan Rogel Cancer Center) |
So, you're funding the pipeline now, hoping for licensing fees and royalties later.
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