Genprex, Inc.

GNPX

Business Summary

Genprex, Inc. is a clinical-stage gene therapy company focused on developing gene-based therapies for large patient populations with unmet medical needs in oncology and diabetes. The company's core business model revolves around the research, development, and eventual commercialization of novel gene therapies, generating revenue primarily through product sales once regulatory approvals are obtained, though it has not yet generated any revenue from product sales ¹. The company operates with two main platforms: an oncology platform utilizing a systemic, non-viral delivery system, and a diabetes technology platform.

The oncology platform features REQORSA® Gene Therapy (quaratusugene ozeplasmid), previously known as GPX-001, which is being developed in combination with approved cancer drugs for Non-Small Cell Lung Cancer (NSCLC) and Small Cell Lung Cancer (SCLC). REQORSA employs the ONCOPREX® Delivery System, using lipid-based nanoparticles to deliver tumor suppressor gene-expressing plasmids to cancer cells intravenously. This therapy is designed to decrease tumor glucose metabolism, interrupt cell signaling pathways, re-establish apoptosis, and increase immune response against cancer cells. Preclinical studies have shown REQORSA to be complementary with targeted drugs and immunotherapies. The TUSC2 gene, central to REQORSA, is licensed exclusively worldwide from The University of Texas MD Anderson Cancer Center ("MD Anderson") ². The company is also in early stages of discovery programs to identify other cancer candidates and biomarkers that predict response to REQORSA.

The diabetes technology platform is based on an exclusive license from the University of Pittsburgh ("UP") for multiple technologies related to a gene therapy product for Type 1 and Type 2 diabetes. The lead diabetes product candidate, GPX-002, uses an adeno-associated virus (AAV) vector containing Pdx1 and MafA genes, administered directly into the pancreatic duct. For Type 1 diabetes, GPX-002 aims to transform alpha cells into functional beta-like cells that produce insulin while potentially evading the immune system. For Type 2 diabetes, it is believed to replenish and rejuvenate exhausted beta cells. Preclinical studies for GPX-002 are ongoing at the University of Pittsburgh, including species analyses for animal models and regulatory planning.

For the fiscal year ended December 31, 2025, Genprex reported net losses of approximately $16.2 million ³, compared to approximately $21.1 million ⁴ for the year ended December 31, 2024. The accumulated deficit as of December 31, 2025, was approximately $171.0 million ⁵. The company's cash and cash equivalents were approximately $7.83 million ⁶ at December 31, 2025. During the year ended December 31, 2025, Genprex sold 1,602,490 shares ⁷ through an At The Market (ATM) Offering Agreement for net proceeds of approximately $10.8 million ⁸. Additionally, under an equity line of credit (ELOC) purchase agreement with Lincoln Park Capital Fund, LLC, the company issued 23,737 shares ⁹ with a value of $365,550 ¹⁰ as commitment shares and sold 749,130 shares ¹¹ for aggregate net proceeds of approximately $5.3 million ¹².

Operationally, Genprex is actively enrolling and treating patients in the Phase 2a expansion portion of its Phase 1/2 Acclaim-1 clinical trial, combining REQORSA with AstraZeneca’s Tagrisso® (osimertinib) for late-stage NSCLC patients with EGFR mutations who have progressed on Tagrisso. The recommended Phase 2 dose (RP2D) of REQORSA was determined to be 0.12 mg/kg ¹³ administered every 21 days ¹⁴. The Acclaim-1 trial has received FDA Fast Track Designation. The Acclaim-2 trial, combining REQORSA with Merck & Co.’s Keytruda® (pembrolizumab) for NSCLC, ceased enrollment in August 2024 due to enrollment challenges and resource prioritization. The Phase 2 expansion portion of the Phase 1/2 Acclaim-3 clinical trial, combining REQORSA with Genentech, Inc.’s Tecentriq® (atezolizumab) as maintenance therapy for ES-SCLC patients, is also enrolling patients, with an RP2D of 0.12 mg/kg ¹⁵ every 21 days ¹⁶. Acclaim-3 has received FDA Fast Track Designation and Orphan Drug Designation.

In diabetes, Genprex formed a wholly-owned subsidiary, Convergen Biotech, Inc. ("Convergen"), in February 2025 to facilitate the separation of the diabetes program, with the intention for Convergen to focus on developing and commercializing GPX-002. In December 2025, the company submitted a meeting request to the FDA to discuss IND-enabling preclinical studies for its Type 1 diabetes gene therapy program, and a meeting occurred in February 2026, with feedback aligning with expectations. The company plans to continue preclinical animal studies and initiate clinical scale production in a cGMP compliant facility.

Business Outlook

Genprex anticipates that its existing cash and cash equivalents of approximately $7.83 million ⁶ at December 31, 2025, will be sufficient to fund its current operations and planned clinical trial activities into the second quarter of 2027 ¹⁷. However, the company explicitly states that this existing capital is not expected to be sufficient to complete the development and commercialization of REQORSA, GPX-002, and other current or future product candidates ¹⁸, indicating a need for substantial additional future funding. The company expects to continue incurring operating losses for the foreseeable future, and these losses are projected to increase as it advances its product candidates through development and seeks regulatory approvals.

A major growth area for Genprex is the continued clinical development of REQORSA. The company expects to complete the enrollment of the first 19 patients for interim analysis in the Phase 2a expansion portion of the Acclaim-1 study in the first half of 2026 ¹⁹, with the interim analysis expected in the second half of 2026 ²⁰. Similarly, for the Acclaim-3 study, enrollment of the first 25 patients for interim analysis in the Phase 2 expansion portion is expected to be completed in the first half of 2026 ²¹, with the interim analysis anticipated in the second half of 2026 ²². The company plans to open additional clinical sites for both Acclaim-1 and Acclaim-3 in 2026 ²³ to expedite patient enrollment. Furthermore, ongoing collaborations with MD Anderson to identify biomarkers that predict response to REQORSA are expected to guide patient selection and improve clinical outcomes, potentially expediting enrollment.

Another significant growth vector is the diabetes gene therapy program, GPX-002. Following a February 2026 meeting with the FDA, the company plans to continue preclinical animal studies, which will enable the finalization of design and initiation of future toxicology studies ²⁴. Subsequent data from these toxicology studies are expected to enable an Investigational New Drug (IND) filing ²⁵. Genprex also plans to begin clinical scale production in a current Good Manufacturing Practices (cGMP) compliant facility to accelerate manufacturing processes necessary for IND-enabling preclinical studies and clinical trials ²⁶. The company is also optimizing constructs and evaluating alternative second-generation approaches, including different AAV and non-viral constructs, with a strategic collaboration on a non-viral lipid nanoparticle delivery system that could allow for potential re-dosing of patients ²⁷.

In terms of capital allocation, Genprex has been actively raising funds through an At The Market (ATM) Offering Agreement, having sold 1,602,490 shares ⁷ for net proceeds of approximately $10.8 million ⁸ during the year ended December 31, 2025. From January 1, 2026, through the filing date of the 10-K, an additional 5,714,798 shares ²⁸ were sold for net proceeds of approximately $13.3 million ²⁹ through the ATM Agreement. The company also entered into an equity line of credit (ELOC) purchase agreement in June 2025, committing Lincoln Park Capital Fund, LLC to purchase up to $12.5 million ³⁰ in shares over a 24-month term ³¹. Under this facility, 749,130 shares ¹¹ were sold for aggregate net proceeds of approximately $5.3 million ¹² during the year ended December 31, 2025. The company expects to continue to seek additional funding through equity offerings, ATM drawdowns, the ELOC facility, debt financings, and strategic collaborations.

Risk Factors

Genprex faces substantial risks, primarily stemming from its need for significant additional funding, as its current cash and equivalents of approximately $7.83 million ⁶ are projected to fund operations only into the second quarter of 2027 ¹⁷, and are insufficient to complete development and commercialization of its product candidates ¹⁸. The company has a history of recurring losses, with an accumulated deficit of approximately $171.0 million ⁵ as of December 31, 2025, and has never been profitable ³². There is substantial doubt about its ability to continue as a going concern without raising additional capital ³³. Development and commercialization risks are high, as product candidates can fail at any stage of preclinical and clinical development, and success in early trials does not guarantee later success ³⁴. Patient enrollment challenges, as experienced with the Acclaim-2 trial, could delay or terminate clinical trials ³⁵. The biopharmaceutical industry is intensely competitive, with many larger, better-financed competitors ³⁶, and rapid technological change could render Genprex's technologies obsolete ³⁷. Manufacturing gene therapies is complex and relies on third-party contract development and manufacturing organizations (CDMOs), which may lead to delays, quality issues, or supply shortages ³⁸. Intellectual property protection is critical but uncertain, with risks of patent invalidation, unenforceability, or infringement by third parties ³⁹. Regulatory approval is lengthy, expensive, and uncertain, with no guarantee of approval or broad indications, and products remain subject to extensive post-approval oversight ⁴⁰. Changes in healthcare laws, such as the Inflation Reduction Act of 2022, could limit payments for pharmaceuticals and reduce profitability ⁴¹. Cybersecurity threats pose risks to sensitive data, and a breach could disrupt operations and harm reputation ⁴².

Management Priorities

Management's overall tone emphasizes the pioneering nature of Genprex as a clinical-stage gene therapy company addressing unmet medical needs in oncology and diabetes. They highlight the strategic importance of their lead oncology candidate, REQORSA®, and the diabetes candidate, GPX-002, noting the multimodal effects of REQORSA and the novel approach of GPX-002. A key strategic priority is the advancement of the Acclaim-1 and Acclaim-3 clinical trials, with expectations to complete enrollment for interim analyses in the first half of 2026 [19, 21] and to conduct these interim analyses in the second half of 2026 [20, 22]. Another strategic focus is the progression of the diabetes program, including continuing preclinical animal studies and initiating clinical scale production in a cGMP compliant facility following a positive FDA meeting in February 2026. Management also underscores the importance of securing additional funding, having raised approximately $10.8 million ⁸ in net proceeds from ATM sales in 2025 and an additional approximately $13.3 million ²⁹ in early 2026, alongside establishing an ELOC facility for up to $12.5 million ³⁰. The formation of Convergen Biotech, Inc. to separate the diabetes program is a strategic move to enhance focus and facilitate direct investment.

View Source Annual Report on SEC.gov ↗

References

[1] Item 7, MD&A — We have never been profitable, we have no products approved for commercial sale, and to date we have not generated any revenue from product sales.
[2] Item 1, Business — Oncology Platform
[3] Item 1A, Risk Factors — We incurred net losses of approximately $16.2 million
[4] Item 1A, Risk Factors — and approximately $21.1 million for the years ended December 31, 2025 and 2024, respectively.
[5] Item 1A, Risk Factors — as of December 31, 2025, had an accumulated deficit of approximately $171.0 million.
[6] Item 1A, Risk Factors — cash and cash equivalents of approximately $7.83 million
[7] Item 1, Business — During the year ended December 31, 2025, we sold 1,602,490 Shares
[8] Item 1, Business — for net proceeds of approximately $10.8 million.
[9] Item 1A, Risk Factors — issued 23,737 shares of common stock to Lincoln Park
[10] Item 1A, Risk Factors — with a value of $365,550 as commitment shares
[11] Item 1A, Risk Factors — sold 749,130 shares of common stock to Lincoln Park as purchase shares
[12] Item 1A, Risk Factors — for aggregate net proceeds of approximately $5.3 million under the 2025 ELOC Facility.
[13] Item 1, Business — the recommended Phase 2 dose ("RP2D") of REQORSA to be 0.12 mg/kg
[14] Item 1, Business — administered every 21 days.
[15] Item 1, Business — the RP2D of REQORSA will be 0.12 mg/kg
[16] Item 1, Business — administered every 21 days
[17] Item 1A, Risk Factors — Although we expect that our existing cash will be sufficient to fund our current operations and planned clinical trial activities into the second quarter of 2027
[18] Item 1A, Risk Factors — Furthermore, we believe that our existing capital will not be sufficient to enable us to complete the development and commercialization of REQORSA, GPX-002, and our other current or future product candidates.
[19] Item 1, Business — We expect to complete the enrollment of the first 19 patients for interim analysis in the Phase 2a expansion portion of the study in the first half of 2026
[20] Item 1, Business — and expect the interim analysis in the second half of 2026.
[21] Item 1, Business — We expect to complete enrollment of the first 25 patients for interim analysis in the Phase 2 expansion portion of the study in the first half of 2026
[22] Item 1, Business — and expect the interim analysis in the second half of 2026.
[23] Item 1, Business — We have initiated the addition of new clinical trial sites for both Acclaim-1 and Acclaim-3, and we expect to open additional sites in 2026.
[24] Item 1, Business — we now plan to continue with preclinical animal studies, as expected, which will allow us to finalize the design and initiate future toxicology studies.
[25] Item 1, Business — Subsequent data from toxicology studies are expected to enable IND filing.
[26] Item 1, Business — Additionally, we plan to begin clinical scale production in a current Good Manufacturing Practices ("cGMP") compliant facility, allowing us to accelerate our manufacturing processes necessary for IND-enabling preclinical studies and clinical trials.
[27] Item 1, Business — Our strategic collaboration with a CDMO to research a non-viral lipid nanoparticle delivery of our diabetes gene therapy drug candidate could allow for potential re-dosing of patients to optimize treatment.
[28] Item 1, Business — From January 1, 2026 through the date of filing of this Annual Report on Form 10-K, we have sold 5,714,798 Shares
[29] Item 1, Business — for net proceeds to us totaling approximately $13.3 million
[30] Item 1A, Risk Factors — Lincoln Park committed to purchase up to $12.5 million in shares of our common stock
[31] Item 1A, Risk Factors — over the 24-month term of the Purchase Agreement
[32] Item 1A, Risk Factors — We have never been profitable and do not expect to be profitable in the foreseeable future.
[33] Item 1A, Risk Factors — Our recurring losses from operations have raised substantial doubt regarding our ability to continue as a going concern.
[34] Item 1A, Risk Factors — A product candidate can fail at any stage of preclinical and clinical development.
[35] Item 1A, Risk Factors — If we have difficulty enrolling a sufficient number of patients to conduct our clinical trials as planned, such as we have experienced with the Acclaim-2 clinical trial for example, we may need to delay, limit or terminate ongoing or planned clinical trials, any of which would have an adverse effect on our business.
[36] Item 1A, Risk Factors — Many of our competitors have greater financial and other resources, such as larger research and development staff and more experienced marketing and manufacturing organizations than we do.
[37] Item 1A, Risk Factors — Technological advances or products developed by our competitors may render our technologies or product candidates obsolete, less competitive or not economical.
[38] Item 1A, Risk Factors — If we are unable to secure contract manufacturers with capabilities to produce the products that we require, we could experience delays in conducting our planned clinical trials.
[39] Item 1A, Risk Factors — If we are unable to protect our intellectual property rights or if our intellectual property rights are inadequate for our technology and product candidates, our competitive position could be harmed.
[40] Item 1A, Risk Factors — We cannot provide assurance that REQORSA, GPX-002, or any of our other current or future product candidates will receive regulatory approval, and without regulatory approval we will not be able to market them.
[41] Item 1A, Risk Factors — For example, the Inflation Reduction Act of 2022 included, among other things, a provision that authorizes CMS to negotiate a “maximum fair price” for a limited number of high-cost, single-source drugs every year, and another provision that requires drug companies to pay rebates to Medicare if prices rise faster than inflation.
[42] Item 1A, Risk Factors — Security breaches and other disruptions could compromise our information and expose us to liability, which would cause our business and reputation to suffer.

Analysis on 5/21/2026

Recent Material Events

2026-07-30Material Event

On July 29, 2026, the Nasdaq Hearings Panel granted Genprex an exception to maintain its listing on The Nasdaq Capital Market despite failing to meet the $1.00 Minimum Bid Price requirement. The company must demonstrate compliance by July 29, 2026, and maintain a closing bid price at or above $1.00 for each trading day until December 7, 2026. Genprex implemented a one-for-twenty-two (1:22) reverse stock split effective July 16, 2026, to address the deficiency. Failure to comply with these terms may result in delisting, which could negatively impact liquidity and capital access. Genprex is a clinical-stage biopharmaceutical company developing targeted therapies for cancer.

View filing ↗

2026-07-14Material Event

Genprex, Inc. announced a one-for-twenty-two (1:22) reverse stock split of its common stock, effective July 16, 2026, to help regain compliance with Nasdaq's $1.00 minimum bid price requirement. The company also provided updates on its Acclaim-1 and Acclaim-3 clinical trials for its gene therapy programs. Genprex, Inc. is a biotechnology company focused on oncology and diabetes gene therapy.

View filing ↗

2026-06-22Material Event

Genprex, Inc. announced that the Canadian Intellectual Property Office issued a Notice of Allowance for a patent covering the use of Reqorsa® Gene Therapy (quaratusugene ozeplasmid) in combination with PD-1 or PD-L1 antibodies for treating lung cancer. This patent expands on existing patents granted in the U.S., Japan, Mexico, Russia, Chile, China, Singapore, Europe, and other regions. Genprex, Inc. is a biotechnology company developing gene therapy products for oncology and diabetes.

View filing ↗

2026-06-18Material Event

At its 2026 Annual Meeting on June 18, 2026, Genprex, Inc. stockholders approved an amended and restated 2018 Equity Incentive Plan, increasing authorized common stock issuance by 1,850,000 shares. Stockholders also approved an amendment to the Certificate of Incorporation granting the Board of Directors sole discretion to implement a reverse stock split between 1:5 and 1:50 at any time before December 31, 2027. Other approved items included the election of directors Jose Antonio Moreno Toscano and Ryan M. Confer, and the ratification of WithumSmith+Brown, PC as the independent auditor. Genprex is a biotechnology company that develops therapeutic products.

View filing ↗

2026-06-12Material Event

Genprex, Inc. received a notification from Nasdaq indicating that its common stock is in violation of the $1.00 minimum bid price requirement. Because the company executed a reverse stock split on October 21, 2025, it is ineligible for a 180-day compliance period. The company intends to request a hearing before a Nasdaq Hearings Panel to stay any delisting action. Management is considering further actions, including another reverse stock split, to regain compliance. Genprex, Inc. is a biotechnology company focused on gene therapy.

View filing ↗