Genprex Provides Clinical Update on Diabetes Gene Therapy Program

Rhea-AI Summary

Genprex (NASDAQ: GNPX) provided a clinical update for its diabetes gene therapy program for GPX-002 on January 7, 2026, reporting preclinical progress and regulatory planning.

Key developments: preclinical proof-of-concept in Type 2 diabetes mouse and non-human primate models showing beta cell rejuvenation and normalized glucose; prior T1D models showed restored normal glucose and improved c-peptide/insulin metrics; manufacturing process transferred to CDMO partners; and a FDA meeting request submitted by end of 2025, with the meeting scheduled in Q1 2026 to discuss IND-enabling studies and next steps toward toxicology studies and cGMP clinical scale production.

Positive

• Preclinical proof-of-concept in T2D mouse and NHP models
• Restored normal glucose in T1D mouse models
• Decreased insulin needs and increased c-peptide in T1D NHP models
• Manufacturing process transferred to experienced CDMOs
• FDA meeting request submitted by end of 2025; meeting in Q1 2026

Negative

• No IND filed yet; IND-enabling toxicology studies not completed
• No human clinical (Phase 1) data reported to date
• No specific timelines provided for IND filing or trial start

Key Figures

Diabetes milestones year 2025 Year in which key GPX-002 diabetes program milestones were achieved

FDA meeting timing Q1 2026 Planned FDA meeting to discuss IND-enabling studies for GPX-002

Indications targeted Type 1 and Type 2 diabetes GPX-002 is being developed to treat both T1D and T2D

Animal models Mouse and NHP Preclinical in vivo models where GPX-002 showed glucose control benefits

Market Reality Check

$2.20 Last Close

Volume Volume 1,838,884 is about 6.71x the 20-day average of 274,011, indicating unusually heavy trading ahead of and around this update. high

Technical Price at $1.89 sits well below the $10.62 200-day MA and 96.56% below the $55.00 52-week high, but only 10.53% above the $1.71 52-week low.

Peers on Argus

Peers in Biotechnology showed mixed moves: CELZ +7.21%, KPRX +1.92%, RNAZ +2.08%, while CLDI -1.71% and INAB -0.20%. With no peers in the momentum scanner and no same-day peer news, GNPX’s +5% move appears company-specific.

Historical Context

Date	Event	Sentiment	Move	Catalyst
Nov 24	Phase 1 data	Positive	-6.7%	Publication of Acclaim-1 Phase 1 lung cancer trial data with RP2D set.
Nov 19	Trial expansion	Positive	-9.5%	Addition of new clinical trial site to expand Acclaim-1 and Acclaim-3.
Nov 18	Patent grant	Positive	-8.7%	USPTO patent for Reqorsa with PD-L1 antibodies, protection through 2037.
Nov 04	EU patent intent	Positive	-11.3%	European Patent Office intent to grant patent for Reqorsa with PD-1 drugs.
Oct 28	Equity offering	Negative	-20.1%	Registered direct offering and warrants raising up to $10M at-the-market.

Pattern Detected

Recent history shows repeated negative reactions to largely positive clinical and patent news, with only the dilutive offering drawing an aligned selloff.

Recent Company History

Over the last few months, Genprex has focused on its REQORSA oncology platform and capital raising. On Oct 28, 2025, a registered direct offering with warrants led to a -20.11% move. Subsequent patent wins and European patent progress in early November were followed by declines between -8.66% and -11.32%. Even favorable Acclaim trial site expansion and Phase 1 data publications in late November coincided with -6.67% to -9.49% drops. Against this backdrop, today’s positive reaction to the GPX-002 diabetes update contrasts with the prior pattern of selling on news.

Market Pulse Summary

This announcement highlights meaningful progress for GPX-002, including expansion into Type 2 diabetes models, in vivo proof-of-concept, technology transfer to CDMOs, and a planned FDA meeting in Q1 2026 to discuss IND-enabling studies. Against prior months of oncology-focused news and capital activity, it underscores Genprex’s diversification into metabolic disease. Investors may watch for initiation of cGMP clinical-scale manufacturing, completion of toxicology studies, and subsequent IND filing as concrete milestones for this program.

Key Terms

gene therapy medical

"a clinical-stage gene therapy company focused on developing life-changing therapies"

Gene therapy is a medical technique that involves altering or replacing faulty genes in a person's cells to treat or prevent disease. It is considered a promising area of innovation because it has the potential to provide long-term or even permanent solutions to genetic conditions. For investors, advancements in gene therapy can signal opportunities in biotech companies and emerging treatments with significant growth potential.

contract development and manufacturing organization technical

"transfer production of GPX-002 to an experienced Contract Development and Manufacturing Organization (CDMO)"

A contract development and manufacturing organization (CDMO) is a specialized service provider that helps other companies design, test, produce and package drugs or medical products on a hired basis. Think of it as an outsourced factory and R&D partner that lets a company scale production without building its own plants. Investors watch CDMO relationships because they affect a drug’s time-to-market, manufacturing costs, supply reliability and overall project risk, all of which influence future revenue and valuation.

cdmo technical

"an experienced Contract Development and Manufacturing Organization (CDMO)"

A contract development and manufacturing organization (CDMO) is a company that provides specialized services to help develop and produce pharmaceutical products for other businesses. Think of it as a contract factory that takes a company's recipe and makes the product on their behalf. For investors, CDMOs are important because they support the growth of pharmaceutical companies and can be key partners in bringing new medicines to market.

investigational new drug regulatory

"request to the FDA for a meeting regarding our Investigational New Drug (IND)-enabling studies"

An investigational new drug is a medication that is still being tested in clinical trials to determine if it is safe and effective for treating a specific condition. For investors, it represents a potential breakthrough that could lead to a new treatment and significant financial gains if successful, but also carries risks since it has not yet been approved for widespread use.

cGMP technical

"clinical scale production of GPX-002 in a current Good Manufacturing Practices (cGMP) compliant facility"

cGMP (current Good Manufacturing Practice) are government-enforced quality standards that manufacturers must follow to ensure drugs, medical devices, and related products are made consistently, safely, and meet specified quality tests. For investors, cGMP compliance is like a restaurant passing health inspections: it reduces the risk of product recalls, regulatory fines, or production stoppages that can hurt revenue and company value, and it supports market access and long-term trust.

lipid nanoparticle medical

"evaluate an alternative second-generation approach for GPX-002 using a non-viral lipid nanoparticle delivery system"

A lipid nanoparticle is a tiny, fat‑based microscopic shell that carries and protects delicate molecules (like RNA or drugs) and helps them enter cells, similar to a microscopic delivery bubble. It matters to investors because this delivery method can make new therapies and vaccines possible or more effective, but also affects manufacturing complexity, scalability, regulatory review and cost — all of which influence a biotech company’s commercial prospects.

toxicology studies medical

"will finalize the design and initiate toxicology studies. Subsequent data from the toxicology studies"

Toxicology studies are safety tests that measure whether a drug, chemical or product can cause harm to people, animals or the environment, often using cells, animals or lab models to spot toxic effects and safe dose ranges. Investors care because these results influence regulatory approval, development costs, timelines and legal risk—much like crash tests signal whether a car is safe to sell and how much fixing or redesign it might require before hitting the market.

AI-generated analysis. Not financial advice.

Company Achieves Clinical Development Milestones in 2025, Advances Program for Future Scale Up and Studies

AUSTIN, Texas, Jan. 7, 2026 /PRNewswire/ -- Genprex, Inc. ("Genprex" or the "Company") (NASDAQ: GNPX), a clinical-stage gene therapy company focused on developing life-changing therapies for patients with cancer and diabetes, today announced a clinical program update on its diabetes gene therapy program for GPX-002, the Company's diabetes gene therapy drug candidate, detailing recent achievements and future advancements. This update follows the recent announcement of positive preliminary preclinical data from studies of GPX-002 in both mouse and non-human primate (NHP) models, specifically addressing Type 2 diabetes (T2D).

"This past year was instrumental for Genprex as we expanded our preclinical research beyond Type 1 diabetes and into Type 2 diabetes, marking the achievement of a significant milestone in our diabetes gene therapy program, including the successful initiation of preclinical research in Type 2 diabetic animal models," said Ryan Confer, President and Chief Executive Officer. "Furthermore, we have successfully executed our strategic plan to transfer production of GPX-002 to an experienced Contract Development and Manufacturing Organization (CDMO) and to submit a request to the FDA for a meeting regarding our Investigational New Drug (IND)-enabling studies, marking a pivotal step toward human clinical trials."

The Company has achieved important milestones within its diabetes program in 2025, marking progress in its clinical drug development. These include:

• Expansion of Research: Genprex commenced preclinical studies in T2D animal models, broadening the scope of its investigational studies beyond T1D. This step allows for an augmented, comprehensive evaluation of GPX-002's effects in relevant disease models. Moreover, preliminary preclinical data demonstrated in vivo proof-of-concept for the novel diabetes gene therapy in T2D animal studies, where GPX-002 rejuvenated exhausted beta cells and normalized glucose levels.
• Regulatory Engagement: Genprex has executed its strategy to submit a meeting request to the U.S. Food and Drug Administration (FDA) by the end of 2025. This meeting, which is scheduled to occur in the first quarter of 2026, is intended to discuss the necessary IND-enabling preclinical studies, a critical step before potentially initiating clinical trials in humans.
• Technology Transfer: Genprex has successfully transferred the manufacturing process for the production of GPX-002 from its academic collaborators where it was previously manufactured, to an experienced, integrated network of CDMOs and other vendors.

These advancements underscore the progression of Genprex's diabetes gene therapy program, moving its lead candidate through the stages of preclinical evaluation and regulatory planning. Looking ahead, the Company is preparing for necessary next steps to advance GPX-002, including:

• Manufacturing Scale Up: The Company plans to begin the clinical scale production of GPX-002 in a current Good Manufacturing Practices (cGMP) compliant facility, allowing Genprex to accelerate its manufacturing processes necessary for IND-enabling preclinical studies and clinical trials.
• Product Optimization: Genprex is continuing work with CDMOs and research partners to optimize constructs and evaluate an alternative second-generation approach for GPX-002 using a non-viral lipid nanoparticle delivery system.
• Toxicology Studies: Following the FDA interaction, Genprex will finalize the design and initiate toxicology studies. Subsequent data from the toxicology studies are expected to enable IND filing. Toxicology studies are a required step of drug development, ensuring that new treatments are safe and effective for human use while identifying potential risks, determining safe dosages and monitoring for side effects.

GPX-002 is under development as a potential treatment for both T1D and T2D. In T1D, GPX-002 is designed to work by transforming alpha cells in the pancreas into functional beta-like cells, which can produce insulin but may be distinct enough from beta cells to evade the body's immune system. In vivo, preclinical studies show that GPX-002 restored normal blood glucose levels for an extended period of time in T1D mouse models. In T1D NHP in vivo models, GPX-002 demonstrated the ability to decrease insulin requirements, increase c-peptide levels and improve glucose tolerance.

In a similar approach for T2D, where autoimmunity is not at play, GPX-002 demonstrated the ability to replenish and rejuvenate exhausted beta cells that make insulin in both mouse and NHP models.

About Genprex, Inc.
Genprex, Inc. is a clinical-stage gene therapy company focused on developing life-changing therapies for patients with cancer and diabetes. Genprex's technologies are designed to administer disease-fighting genes to provide new therapies for large patient populations with cancer and diabetes who currently have limited treatment options. Genprex works with world-class institutions and collaborators to develop drug candidates to further its pipeline of gene therapies in order to provide novel treatment approaches. Genprex's oncology program utilizes its systemic, non-viral Oncoprex® Delivery System which encapsulates the gene-expressing plasmids using lipid-based nanoparticles in a lipoplex form. The resultant product is administered intravenously, where it is taken up by tumor cells that then express tumor suppressor proteins that were deficient in the tumor. The Company's lead product candidate, Reqorsa® Gene Therapy (quaratusugene ozeplasmid), is being evaluated in two clinical trials as a treatment for NSCLC and SCLC. Each of Genprex's lung cancer clinical programs has received a Fast Track Designation from the FDA for the treatment of that patient population, and Genprex's SCLC program has received an FDA Orphan Drug Designation. Genprex's diabetes gene therapy approach is comprised of a novel infusion process that uses an AAV vector to deliver Pdx1 and MafA genes directly to the pancreas. In models of Type 1 diabetes, GPX-002 transforms alpha cells in the pancreas into functional beta-like cells, which can produce insulin but may be distinct enough from beta cells to evade the body's immune system. In a similar approach for Type 2 diabetes, where autoimmunity is not at play, GPX-002 is believed to rejuvenate and replenish exhausted beta cells.

Interested investors and shareholders are encouraged to sign up for press releases and industry updates by visiting the Company Website, registering for Email Alerts and by following Genprex on Twitter, Facebook and LinkedIn.

Cautionary Language Concerning Forward-Looking Statements
Statements contained in this press release regarding matters that are not historical facts are "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995. These forward-looking statements are made on the basis of the current beliefs, expectations and assumptions of management, are not guarantees of performance and are subject to significant risks and uncertainty. These forward-looking statements should, therefore, be considered in light of various important factors, including those set forth in Genprex's reports that it files from time to time with the Securities and Exchange Commission and which you should review, including those statements under "Item 1A – Risk Factors" in Genprex's Annual Report on Form 10-K for the year ended December 31, 2024.

Because forward-looking statements are subject to risks and uncertainties, actual results may differ materially from those expressed or implied by such forward-looking statements. Such statements include, but are not limited to, statements regarding: Genprex's ability to advance the clinical development, manufacturing and commercialization of its product candidates in accordance with projected timelines and specifications, including anticipated manufacturing scale-up and technology transfer of GPX-002; the timing and success of Genprex's clinical trials, its intended regulatory submissions and any resulting regulatory approvals, including the outcome of an upcoming meeting with the FDA and potential future toxicology studies as well as the Company's beliefs about the anticipated effects of GPX-002 and its potential as a therapeutic approach; the effect of Genprex's product candidates, alone and in combination with other therapies, on cancer and diabetes; Genprex's future growth and financial status, including Genprex's ability to maintain compliance with the continued listing requirements of The Nasdaq Capital Market and to continue as a going concern and to obtain capital to meet its long-term liquidity needs on acceptable terms, or at all; Genprex's commercial and strategic partnerships, including those with its third party vendors, suppliers and manufacturers and their ability to successfully perform and scale up the manufacture of its product candidates; Genprex's intellectual property and licenses; and Genprex's current expectations, estimates, forecasts and projections about the industry and markets in which it operates.

These forward-looking statements should not be relied upon as predictions of future events and Genprex cannot assure you that the events or circumstances discussed or reflected in these statements will be achieved or will occur. If such forward-looking statements prove to be inaccurate, the inaccuracy may be material. You should not regard these statements as a representation or warranty by Genprex or any other person that Genprex will achieve its objectives and plans in any specified timeframe, or at all. You are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date of this press release. Genprex disclaims any obligation to publicly update or release any revisions to these forward-looking statements, whether as a result of new information, future events or otherwise, after the date of this press release or to reflect the occurrence of unanticipated events, except as required by law.

Genprex, Inc.
(877) 774-GNPX (4679)

GNPX Investor Relations
investors@genprex.com

GNPX Media Contact
Kalyn Dabbs
media@genprex.com

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SOURCE Genprex, Inc.

FAQ

What progress did Genprex (GNPX) report for GPX-002 on January 7, 2026?

Genprex reported preclinical proof-of-concept in T2D mouse and NHP models, transferred manufacturing to CDMOs, and submitted an FDA meeting request scheduled for Q1 2026.

When is Genprex meeting the FDA about GPX-002 IND-enabling studies?

The company submitted a meeting request by the end of 2025 and scheduled the FDA meeting for Q1 2026 to discuss IND-enabling studies.

What preclinical efficacy did GPX-002 show in T1D and T2D models?

In T1D, GPX-002 restored normal glucose in mice and improved c-peptide and insulin metrics in NHP; in T2D, it rejuvenated exhausted beta cells and normalized glucose in mouse and NHP models.

Has Genprex begun clinical-scale cGMP production of GPX-002 (GNPX)?

Genprex completed technology transfer to CDMOs and plans to begin clinical-scale cGMP production to support IND-enabling studies.

What are the next regulatory and development steps for GPX-002?

After the FDA interaction, Genprex will finalize and initiate toxicology studies, with subsequent data intended to enable an IND filing.