Genprex Inc 8-K Filings

Genprex, Inc. reported that a Nasdaq Hearings Panel has formally determined the company has regained compliance with the Nasdaq Capital Market $1.00 Minimum Bid Price requirement under Listing Rule 5550(a)(2). This follows the Panel’s earlier decision granting Genprex an exception to work toward compliance.

The company must now maintain a closing bid price at or above $1.00 for every trading day through December 7, 2026, which is the full extent of the Panel’s discretion on this matter. The Panel will retain jurisdiction over Genprex until that date. If the company becomes non-compliant with any other Nasdaq listing rule before December 7, 2026, it will have seven calendar days to present a plan to cure the deficiency, after which the Panel may either permit additional time for compliance or move to delist the company.

Genprex, Inc. reported a new collaboration with Roche Diagnostics to validate biomarkers for selecting non-small cell lung cancer (NSCLC) patients in clinical trials. The work focuses on TROP2 and PTEN, building on data showing that high TROP2 H-scores and low PTEN H-scores predicted patient response in preclinical studies and were associated with longer Progression Free Survival in clinical studies for NSCLC patients with TROP2 H-scores above 100 and PTEN H-scores below 100.

The collaboration uses Roche’s assay-development capabilities and its TROP2 antibody, which underlies an AI-driven NSCLC companion diagnostic that has received FDA Breakthrough Device Designation. Roche will perform assay validation with this antibody, and Genprex anticipates completing validation studies by approximately the end of 2026, with potential integration of TROP2-based patient selection into its NSCLC clinical program thereafter, depending on validation results. Genprex frames this as part of its strategy to enable more precise, biomarker-guided treatment for NSCLC.

Genprex, Inc. received a conditional extension from a Nasdaq Hearings Panel to keep its common stock listed on The Nasdaq Capital Market under an exception to the $1.00 minimum bid price requirement. The exception requires Genprex to evidence compliance with the bid-price rule by July 29, 2026 and then maintain a closing bid of at least $1.00 on every trading day through December 7, 2026, during which period the Panel retains jurisdiction and may impose a discretionary monitor.

Genprex adds a risk-factor update explaining that it has implemented a 1-for-22 reverse stock split, effective July 16, 2026, as a step toward compliance, but warns this action may pressure its share price and reduce trading liquidity. The company highlights that it must also satisfy other Nasdaq standards, including minimum stockholders’ equity of $2.5 million, and notes a July 22, 2026 Nasdaq rule change under which failure to maintain a market value of listed securities of at least $5 million for 30 consecutive business days would result in immediate suspension and delisting. Genprex cautions that any delisting could materially depress its stock price and hinder access to capital.

Genprex, Inc. approved a one-for-twenty-two Reverse Stock Split of its common stock, effective at 12:01 a.m. Eastern Time on July 16, 2026. Every 22 outstanding shares will convert into 1 share, with fractional positions rounded up to the next whole share. Based on 11,108,577 shares outstanding on July 13, 2026, Genprex estimates about 504,936 shares will be outstanding after the split. The split does not change par value or authorized share count, and outstanding options and warrants will be proportionally adjusted.

The company is using this split as part of efforts to address Nasdaq’s $1.00 minimum bid price requirement after receiving a June 10, 2026 delisting notice and requesting a hearing before a Nasdaq panel. Genprex cautions that the split may not restore compliance and could negatively affect share price, liquidity and market capitalization, with delisting potentially impairing capital-raising ability and overall business.

The company also highlights progress in its REQORSA gene therapy lung cancer program, including ongoing Phase 2 expansion enrollment in the Acclaim-1 and Acclaim-3 trials, FDA Fast Track and Orphan Drug designations, and emerging biomarker data (TROP-2 and PTEN) that may guide patient selection and optimize outcomes.

Genprex, Inc. reports that the Canadian Intellectual Property Office has issued a Notice of Allowance for a patent covering the use of REQORSA Gene Therapy (quaratusugene ozeplasmid) with PD-1 or PD-L1 antibodies to treat both non-small cell and small cell lung cancer. This patent builds on earlier REQORSA combination patents already granted in the U.S., Japan, Mexico, Russia, Chile, China, Singapore, Europe, Korea, Australia and Israel, further reinforcing the company’s global intellectual property position. Genprex believes the Canadian patent provides important protection for therapeutic combinations now being evaluated in the Acclaim-3 clinical trial. The company highlights Canadian Cancer Society data showing lung and bronchus cancer is the most commonly diagnosed cancer in Canada and the leading cause of cancer death, underscoring the potential need for new treatment options.

Genprex, Inc. reported results from its 2026 annual stockholders meeting, where investors approved an Amended and Restated 2018 Equity Incentive Plan adding 1,850,000 shares of common stock for potential equity awards. The plan now runs through April 15, 2036.

Stockholders also re-elected Jose Antonio Moreno Toscano and Ryan M. Confer as Class III directors and ratified WithumSmith+Brown, PC as auditor for the year ending December 31, 2026. An advisory vote approved compensation for named executive officers.

Shareholders further authorized an amendment to the certificate of incorporation allowing a reverse stock split at a ratio between 1-for-5 and 1-for-50, which the board may implement at its discretion any time before December 31, 2027.

Genprex, Inc. reported that Nasdaq has determined to delist its common stock after the shares closed below $1.00 for 30 consecutive business days, violating the Nasdaq Listing Rule 5550(a)(2) minimum bid price requirement. Because Genprex executed a reverse stock split on October 21, 2025, it is not eligible for a standard 180-day compliance period under Listing Rule 5810(c)(3)(A)(iv). The company plans to timely request a hearing before a Nasdaq Hearings Panel, which will automatically stay any suspension or delisting action during the process and any extension period the Panel may grant.

Genprex added a risk factor explaining that failure to regain and maintain compliance with Nasdaq’s continued listing standards could lead to delisting, potentially harming its stock price, liquidity, and ability to access capital markets. The company states it intends to take definitive steps to meet the bid price requirement, including considering another reverse stock split if appropriate, while cautioning there is no assurance of success and noting possible negative effects of a reverse split on price and liquidity.

Genprex, Inc. filed an 8-K to highlight new clinical data from an abstract presented at the 2026 ASCO Annual Meeting by its research collaborators. The work examined predictive biomarkers in lung cancer patients treated with its lead gene therapy candidate, Reqorsa (quaratusugene ozeplasmid).

The abstract reported that in Non-Small Cell Lung Cancer patients from Genprex’s Acclaim trials, Trop-2 H-scores above 100 and PTEN H-scores below 100 were associated with longer progression-free survival. In Small Cell Lung Cancer patients, Trop-2 levels were low and PTEN expression did not correlate with progression-free survival.

Genprex also found that NSCLCs with strong (3+) Trop-2 staining showed a near-significant relationship with progression-free survival, and plans to further study high Trop-2 expression as a potential biomarker for Reqorsa. The filing reiterates standard forward-looking statement cautions and related development and financing risks.

Genprex, Inc. reported that its research collaborators presented positive preclinical results for its diabetes gene therapy candidate PM (GPX-002) at the 2026 ASGCT Annual Meeting. In Type 2 diabetic mouse models on a high-fat diet, pancreatic delivery of AAV-Pdx1/MafA gene therapy reversed hyperglycemia and improved glucose-stimulated insulin secretion, indicating better β-cell function.

Electron microscopy showed more total and mature insulin granules and fewer immature granules after treatment, while transcriptomic analysis suggested β-cells shifted toward a more mature state. Genprex believes this preclinical work is a pivotal step toward a potentially transformative Type 2 diabetes treatment, with a technique the company views as technically translatable to humans.

Genprex, Inc. announced that the Israel Patent Office has granted a patent covering the use of its REQORSA Gene Therapy (quaratusugene ozeplasmid) in combination with PD-1 antibodies for the treatment of cancer. This extends Genprex’s intellectual property around REQORSA beyond prior patents granted in the U.S., Japan, Mexico, Russia, Australia, Chile, China, Singapore and Europe.

REQORSA is initially being developed with approved cancer drugs to treat lung cancer, where preclinical studies have shown it can complement targeted drugs and immunotherapies. The company highlights Israeli public health data showing lung cancer is a leading cause of cancer deaths, underscoring the medical need in that market.

Genprex, Inc. reported that its research collaborators will present positive preclinical data on its diabetes gene therapy candidate GPX-002 (Pdx1/MafA gene therapy) at the 2026 American Society of Gene and Cell Therapy Annual Meeting in Boston.

In Type 2 diabetic mouse models induced by a high fat diet, intrapancreatic delivery of an AAV-8 vector encoding Pdx1 and MafA reversed hyperglycemia and restored glucose-stimulated insulin secretion to levels similar to mice on a regular diet. Electron microscopy and transcriptomic analyses showed more mature insulin granules and a shift of β-cells toward a mature state after treatment. The company highlighted that direct pancreatic delivery via endoscopic retrograde cholangiopancreatography could make this approach technically translatable to humans, while emphasizing usual forward-looking statement cautions and development risks.

Genprex, Inc. filed a report describing a new Sponsored Research Agreement with The University of Texas MD Anderson Cancer Center to study biomarkers that may predict patient response to its Reqorsa Gene Therapy for non-small cell and small cell lung cancer.

The company also highlights progress in its Acclaim-1 and Acclaim-3 Phase 1/2 trials combining Reqorsa with Tagrisso and Tecentriq. Early Phase 1 data showed no dose limiting toxicities and signals of efficacy, including prolonged progression free survival and partial remissions in individual patients who continue on treatment.

Genprex, Inc. reported that its research collaborators will present three posters at the 2026 AACR Annual Meeting featuring new preclinical data on its lead candidate, REQORSA (quaratusugene ozeplasmid, “Quar Oze”), for non-small cell lung cancer.

The first study identifies TROP2 and PTEN expression patterns as potential biomarkers of primary resistance to TUSC2 gene therapy across NSCLC cell lines, organoids and xenograft models, helping explain which tumors may not respond.

The second study shows Quar Oze-driven TUSC2 overexpression induces strong tumor cell death in ALK-positive NSCLC models and enhances the effect of the ALK inhibitor alectinib, including in alectinib-resistant tumors, with combination treatment achieving the greatest tumor shrinkage and survival benefits in mice.

The third study demonstrates that restoring TUSC2 via Quar Oze boosts natural killer (NK) cell cytotoxicity, improves antitumor immune responses and, in many cases, leads to complete tumor regression in mouse models, supporting TUSC2 as both a tumor suppressor and immunomodulatory target.

Genprex, Inc. reported that the Japanese Patent Office issued a favorable appeal decision to grant a patent covering use of REQORSA Gene Therapy with PD‑L1 antibodies to treat cancer, and the European Patent Office issued a decision to grant a patent for REQORSA in combination with PD‑1 antibodies. Genprex holds an exclusive license to these patents and states they strengthen protection for therapeutic combinations, including its Acclaim‑3 trial in small cell lung cancer.

The company notes it already has granted patents for REQORSA and PD‑L1 combinations in the U.S. and Korea, with a pending grant in Australia, and REQORSA and PD‑1 combinations in multiple regions including the U.S., Japan and the EU. Acclaim‑3 is a Phase 1/2 trial of REQORSA plus Genentech’s Tecentriq as maintenance therapy for extensive‑stage small cell lung cancer. The Phase 2 expansion is expected to enroll about 50 patients, with an interim analysis planned after the 25th patient has 18 weeks of follow‑up. Genprex expects to complete enrollment of the first 25 patients in the first half of 2026 and conduct the interim analysis in the second half of 2026. The trial has U.S. FDA Fast Track and Orphan Drug designations.

Genprex, Inc. reported that IP Australia issued a Notice of Acceptance for its patent application covering the use of REQORSA Gene Therapy with PD-L1 antibodies to treat cancers. If granted, this patent would secure exclusivity for this drug combination in Australia and strengthen Genprex’s intellectual property portfolio alongside granted patents in the U.S. and Korea.

The company is also pursuing additional patent applications in Europe, Canada, Brazil, China and Israel and has opened a new Acclaim-3 clinical trial site at the University of Kentucky. Acclaim-3 is a Phase 1/2 trial of REQORSA plus Tecentriq as maintenance therapy for extensive stage small cell lung cancer, supported by FDA Fast Track and Orphan Drug Designations.

The Phase 2 expansion is expected to enroll about 50 patients, with an interim analysis planned after the 25th patient reaches 18 weeks of follow-up. Genprex expects to complete enrollment of these 25 patients in the first half of 2026 and conduct the interim analysis in the second half of 2026.

Genprex, Inc. reported that Nasdaq’s Hearings Panel has determined the company has regained compliance with Nasdaq Listing Rule 5550(b)(1), which requires minimum stockholders’ equity of $2.5 million. This restores the company’s standing with Nasdaq’s equity requirement after a prior deficiency notice received on August 19, 2025.

Under Nasdaq Listing Rule 5815(d)(4)(B), Genprex will be under a mandatory panel monitor through January 7, 2027. If during this one-year period Nasdaq staff again finds the company out of compliance with the same minimum stockholders’ equity rule, staff will issue a delisting determination without providing an additional cure period or plan-of-compliance process, although Genprex would be able to request a new hearing and its securities could then be delisted from Nasdaq.

Genprex, Inc. filed an 8-K describing new investor presentation materials and important updates on its GPX-002 diabetes gene therapy program. The company furnished an investor deck that may be used in meetings with investors and analysts and made available on its website.

Genprex reported 2025 milestones for GPX-002, including starting preclinical research in Type 2 diabetes animal models, transferring production of GPX-002 to an experienced contract development and manufacturing organization, and submitting a request to the FDA for a meeting on its Investigational New Drug–enabling studies, described as a pivotal step toward human clinical trials. GPX-002 is being developed for both Type 1 and Type 2 diabetes, with preclinical mouse and non-human primate data showing restored or improved blood glucose control, reduced insulin requirements, higher c‑peptide levels, and improved glucose tolerance.

Genprex, Inc. reports that a Nasdaq Hearings Panel has determined the company has regained compliance with Nasdaq’s $1.00 minimum bid price requirement. The Panel also approved an exception giving Genprex until December 31, 2025 to demonstrate long-term compliance with the Nasdaq stockholders’ equity requirement, with the possibility of further extension to February 9, 2026 at the Panel’s discretion.

The Panel may reconsider this exception if new events make continued listing inadvisable, and there is no assurance of any extension beyond December 31, 2025. Genprex states it believes it will need to complete additional capital raising transactions to regain compliance with the stockholders’ equity requirement, and notes there is no guarantee such financing will be available on acceptable terms, or at all.

Genprex, Inc. filed a prospectus supplement for an at-the-market offering of additional common stock with an aggregate offering price of up to $75,000,000 under its existing agreement with H.C. Wainwright & Co., LLC.

This supplement updates the prior ATM prospectus documents and must be read together with them. Genprex has previously sold 796,065 shares of common stock for aggregate gross proceeds of $14,796,375 under the same Sales Agreement. A legal opinion from Lowenstein Sandler LLP covering the validity of the newly registered shares is included as an exhibit.

Genprex, Inc. reported that it has added Gabrail Cancer Center in Canton, Ohio as a new clinical trial site for its Acclaim-1 and Acclaim-3 studies of lead drug candidate REQORSA Gene Therapy in lung cancer. The company also plans to add and open additional Acclaim trial sites over the coming months to reach more patients and speed enrollment.

Acclaim-1 is a Phase 1/2 trial in late-stage non-small cell lung cancer with EGFR mutations combining REQORSA with Tagrisso, with a Phase 2a expansion targeting about 33 patients and an interim analysis after 19 patients, which Genprex currently expects to fully enroll in the first half of 2026; the trial has FDA Fast Track Designation. Acclaim-3 is a Phase 1/2 trial in extensive stage small cell lung cancer combining REQORSA with Tecentriq as maintenance therapy, with Phase 2 expansion for about 50 patients and an interim analysis after the 25th patient reaches 18 weeks of follow-up, also expected to reach that enrollment milestone in the first half of 2026, and benefits from FDA Fast Track and Orphan Drug Designations.

Genprex, Inc. reported that the U.S. Patent and Trademark Office has granted a patent covering the use of its lead drug candidate, REQORSA Gene Therapy (quaratusugene ozeplasmid), in combination with PD‑L1 antibodies such as Tecentriq, with protection extending through 2037. This patent is intended to secure exclusivity for this cancer treatment combination by preventing competitors from making, using or selling the same drug combination.

The company highlighted that REQORSA is being studied in the Acclaim‑3 Phase 1/2 trial as maintenance therapy with Tecentriq for patients with extensive stage small cell lung cancer. Phase 1 dose escalation showed REQORSA was generally well tolerated with no dose‑limiting toxicities, and the Phase 2 expansion is expected to enroll about 50 patients. The primary goal is to assess 18‑week progression‑free survival, with an interim analysis planned after the 25th patient reaches 18 weeks of follow up in the first half of 2026. Acclaim‑3 is supported by FDA Fast Track and Orphan Drug designations.

Genprex (GNPX) reported an intellectual property update. The company announced that the European Patent Office communicated its intent to grant a patent covering the use of REQORSA Gene Therapy (quaratusugene ozeplasmid) with PD-1 antibodies for treating cancer.

If granted, this patent would build on existing protection for REQORSA in combination with PD-1 antibodies already granted in the U.S., Japan, Mexico, Russia, Australia, Chile, China, and Singapore. Genprex notes REQORSA is being developed alongside approved cancer drugs for lung cancer, with preclinical studies indicating complementarity with targeted therapies and immunotherapies.

Genprex (GNPX) entered into a registered direct offering of 377,780 shares at $9.00 per share, alongside a concurrent private placement of warrants exercisable for up to 755,560 shares at an exercise price of $8.75. The transaction is expected to close on or about October 29, 2025, subject to customary conditions.

The company expects approximately $3.0 million in net proceeds from the share sale, excluding any warrant exercises. If the private warrants are fully exercised, Genprex would receive additional gross proceeds of about $6.6 million. Proceeds are earmarked for working capital and general corporate purposes.

Placement agent compensation includes a 7.0% cash fee and a 1.0% management fee, expense reimbursements, and 22,667 placement agent warrants at a $11.25 exercise price. Genprex agreed to a 5‑day issuance/filing standstill and a 1‑year prohibition on variable‑rate issuances, with exceptions for its ATM and equity line. The company will file an S‑1 for warrant share resale within 30 days and target effectiveness within 60 days (or 90 days if fully reviewed). A beneficial ownership cap limits exercises to 4.99%, adjustable up to 9.99%.

Genprex, Inc. (GNPX) reported that its research collaborators presented positive preclinical data for Reqorsa Gene Therapy (quaratusugene ozeplasmid) in ALK-EML4 positive non-small cell lung cancer at the 2025 AACR-NCI-EORTC conference in Boston.

The study showed REQORSA can overexpress the tumor suppressor gene TUSC2 in ALK+ NSCLC cell lines and patient-derived organoids, inducing apoptosis, including in cells resistant to alectinib. Combining REQORSA with alectinib further increased apoptosis, and in a mouse xenograft model the combination improved survival versus control. The Company stated these results support a potential future clinical trial in ALK-positive lung cancer.

Genprex, Inc. (GNPX) entered a financing on October 23, 2025. The company agreed to sell 243,622 registered shares at $11.21 per share in a registered direct offering and, in a concurrent private placement, issue warrants exercisable for up to 487,244 shares at an $11.00 exercise price.

Genprex expects approximately $2.3 million in net proceeds from the registered direct, excluding any warrant exercise proceeds. If the private warrants are exercised in full, the company would receive approximately $5.4 million in additional gross proceeds. The company plans to use proceeds for working capital and general corporate purposes.

Separately, Genprex noted Nasdaq listing matters. A one-for-fifty reverse stock split was implemented on October 21, 2025 to address the $1.00 minimum bid price requirement, which must be maintained for 10 consecutive business days. The Nasdaq Hearings Panel granted an exception through October 31, 2025, with potential discretion to extend to February 9, 2026.

Genprex reported that its research collaborators will present positive preclinical data on REQORSA (quaratusugene ozeplasmid) for ALK-EML4 positive non-small cell lung cancer at the 2025 AACR-NCI-EORTC conference in Boston. The studies showed that REQORSA increased TUSC2 expression and activated apoptotic pathways across ALK+ cell lines and patient-derived organoids, including models with acquired resistance to the ALK inhibitor alectinib.

In a mouse model, alectinib alone shrank tumors by 60%, while REQORSA alone and the REQORSA–alectinib combination each shrank tumors by 79%. Researchers also observed slower tumor regrowth after combined treatment versus single agents and increased markers of apoptosis (including caspase 3/7 activity). The abstract concludes that these in vitro and in vivo findings support a potential clinical trial of REQORSA in ALK-EML4 positive NSCLC.

Genprex, Inc. (GNPX) effected a one-for-fifty reverse stock split of its common stock, effective at 12:01 a.m. on October 21, 2025. The action consolidates every 50 pre-split shares into 1 share.

After giving effect to the reverse split, the company reports 1,004,326 shares outstanding as of October 21, 2025, prior to any rounding of fractional shares. The filing lists no other corporate changes or transactions related to this event.

Genprex received a Nasdaq Hearings Panel exception to regain compliance with the $1.00 Minimum Bid Price and minimum stockholders’ equity listing standards through October 31, 2025, with Panel discretion to extend to February 9, 2026. The Panel may reconsider the exception, and no further extension is assured.

To support compliance, the Board approved a 1-for-50 reverse stock split effective at 12:01 a.m. ET on October 21, 2025. Trading will begin on a split-adjusted basis that day under ticker GNPX; fractional shares will be rounded up to the next whole share. Par value and authorized shares are unchanged, and outstanding options and warrants will be adjusted per their terms.

Clinical updates: Acclaim-1 (NSCLC) Phase 2a targets ~33 patients with an interim analysis after the first 19; enrollment of those 19 is expected in the first half of 2026 with interim analysis in the second half of 2026 (FDA Fast Track). Acclaim-3 (ES‑SCLC) Phase 2 plans ~50 patients across ~10–15 U.S. sites, with a futility look after the 25th patient reaches 18 weeks; the same first‑half/second‑half 2026 timing is expected (FDA Fast Track and Orphan Drug).

Genprex, Inc. reports that Nasdaq has notified the company it is not in compliance with key listing standards, creating a risk of delisting from the Nasdaq Capital Market. Nasdaq’s Listing Qualifications Staff cited stockholders’ equity of $1,391,195 as of June 30, 2025, which is below the required $2.5 million minimum, and noted the company also does not meet alternative market value or net income standards.

The notice follows an earlier determination to delist Genprex for failing to meet the $1.00 per share minimum bid price requirement within a 180-day grace period and not qualifying for an additional extension due to not meeting Nasdaq’s $5,000,000 initial listing equity threshold. Genprex has requested a hearing before a Nasdaq Hearings Panel, which temporarily stays suspension or delisting while it presents a plan to regain compliance, but the company cautions there is no assurance the panel will grant continued listing.

Genprex, Inc. reported new patent progress for its lead gene therapy, REQORSA (quaratusugene ozeplasmid), in combination with checkpoint inhibitor drugs. The U.S. Patent and Trademark Office issued a notice of allowance for a patent covering REQORSA with PD-L1 antibodies such as Tecentriq, and the European Patent Office issued a notice of allowance for a patent covering REQORSA with PD-1 antibodies. Both patents will expire in 2037 at the earliest.

The company already holds patents for REQORSA with PD-L1 antibodies in Korea and for REQORSA with PD-1 antibodies in the U.S., Japan, Mexico, Russia, Australia, Chile, China, Korea and Singapore, and is pursuing additional applications in Europe, Canada, Brazil, China and Israel that could apply to its Acclaim-3 trial. Acclaim-3 is a Phase 1/2 study of REQORSA plus Genentech’s Tecentriq as maintenance therapy for extensive stage small cell lung cancer, and this trial has received FDA Fast Track and Orphan Drug designations.

Genprex, Inc. reported results of its 2025 annual stockholder meeting. Stockholders approved an amended and restated 2018 Equity Incentive Plan, adding authorization for an additional 6,500,000 shares of common stock, extending the plan term to June 30, 2035, and removing outdated tax-driven performance compensation provisions. They re-elected Class II director William R. Wilson, Jr. and ratified WithumSmith+Brown, PC as auditor for the year ending December 31, 2025.

Investors gave advisory approval to named executive officer pay and formally approved the amended equity plan. They also approved, under Nasdaq Listing Rule 5635(d), a potential issuance of more than 20% of outstanding common stock under the company’s purchase agreement with Lincoln Park Capital Fund, LLC. In addition, stockholders authorized a reverse stock split of issued common shares at a ratio between 1-for-10 and 1-for-50, which the board may implement at its discretion any time before December 31, 2026.

Genprex announced positive preclinical research results for GPX-002, its diabetes gene therapy drug candidate, presented at the 2025 American Diabetes Association Scientific Sessions. The research demonstrated significant breakthroughs in treating Type 1 diabetes using gene therapy.

Key findings include:

• Successfully converted alpha cells into insulin-secreting beta-like cells in animal models, maintaining improved glucose control for three months
• Utilized rAAV delivery system through pancreatic duct infusion to deliver Pdx1 and MafA genes
• Non-human primates showed improved glucose tolerance and reduced insulin requirements one month post-treatment
• Temporary immunosuppression using rituximab, rapamycin, and steroids proved effective for 3 months, with ongoing studies evaluating 6-month protocols

The research suggests GPX-002 could potentially revolutionize diabetes treatment through cell transdifferentiation, though continued studies are needed to optimize immunosuppression protocols and evaluate long-term efficacy in both Type 1 and Type 2 diabetes models.

Genprex announced positive preclinical data for GPX-002, its diabetes gene therapy candidate, presented at the 2025 ADA Scientific Sessions. The research showcased a novel non-viral delivery approach using lipid nanoparticles (LNPs), marking a significant advancement in diabetes treatment technology.

Key findings include:

• Successful testing of 9 LNPs with patented LipexSil® lipids, demonstrating efficient cell transfection in mouse Islets of Langerhans
• ALX-184 LNP showed particular promise in crossing the pancreatic membrane and effectively delivering mRNA payloads
• The non-viral delivery system potentially enables repeat dosing without immunosuppression, a significant advantage over traditional AAV delivery methods

This research runs parallel to Genprex's ongoing AAV construct studies, representing a strategic expansion of their diabetes program. The company believes these findings provide crucial proof of concept for advancing their Type 1 diabetes treatment approach, though they caution that all forward-looking statements are subject to risks and uncertainties.