Month: September 2026

Proprietary technology currently used across EzFill’s 141-truck fleet in 15 markets combines dynamic routing and scheduling, driver and route analytics, live fuel monitoring and end-to-end fuel reconciliation

MIAMI, FL, Sept. 15, 2026 (GLOBE NEWSWIRE) — NextNRG, Inc. (NASDAQ: NXXT), a pioneer in AI-driven energy innovation transforming how energy is produced, managed and delivered, today announced that its mobile fueling subsidiary, EzFill, is developing a white-label version of its proprietary telematics platform to license to third-party fleet operators, fuel distributors and mobile fueling companies.

Developed to manage EzFill’s own mobile fueling operations, the platform is currently deployed across the Company’s fleet of 141 trucks operating in 15 markets. The technology brings together routing, scheduling, driver and route performance, real-time truck fuel levels and fuel delivery data in a single operating system, giving managers detailed visibility into fleet activity and fuel movement.

“We built this technology to solve problems we face every day in our own operation,” said Yehuda Levy, CEO of EzFill. “It gives our managers visibility into how our trucks are being routed, how drivers are performing, how much fuel is on each truck and how much fuel is being delivered at every stop. We believe other fleet and fuel operators face many of the same challenges, and we are now preparing to license the platform, including a white-label version that can be adapted for their operations.”

“The strongest validation we’ve received comes from our largest customer, one of the world’s largest online retailers, which views our platform and its integration with their back-end systems as a differentiator, and has encouraged us to make it available to its other fueling providers. When a customer of that scale tells you your software is the reason they work with you, it says something about the technology,” said Michael D. Farkas, Founder and CEO of NextNRG. “EzFill developed this platform to optimize its own operations, and it has become integral to how we manage the fleet. We believe the same technology can help other fleet and fuel operators improve visibility, efficiency and accountability across their operations.”

Unlike conventional fleet tracking systems that primarily monitor vehicle location, EzFill’s platform connects routing, operational and fuel data to provide a more complete view of each route and delivery. The system evaluates planned routes against those actually driven, identifies deviations and additional stops, and uses live fuel volumes on each truck to help managers plan routes based on available fuel, scheduled stops and delivery requirements.

At the fuel-delivery level, the platform adds another layer of accountability by tracking fuel throughout the delivery process. It monitors fuel levels within EzFill’s trucks, fuel delivered at each stop and vehicle-level fuel data captured through EzFill’s Bluetooth-enabled fuel monitoring technology, allowing the system to reconcile fuel moving into and out of each truck and compare delivered volumes against the receiving vehicle’s fuel level.

Licensing the platform represents an opportunity for EzFill to extend technology developed for its own operations to a broader market. Initial interest from fleet and fuel operators has been strong, and the Company is in active discussions with prospective licensees. Potential applications include mobile fueling companies, fuel distributors, and other fleet-intensive businesses looking to improve routing, scheduling, fuel accountability, and driver performance.

The Company expects to provide additional information as development progresses.

About EzFill

EzFill is a leading on-demand mobile fueling service and a subsidiary of NextNRG, Inc. (NASDAQ: NXXT). EzFill delivers on-demand mobile fueling to commercial customers, including vehicle fleets, businesses and events, eliminating the need for drivers to leave their routes or job sites to refuel.

About NextNRG, Inc.

NextNRG, Inc. (NextNRG) is Powering What’s Next by deploying its AI-driven Smart Controller, a proprietary AI technology that continuously optimizes how energy is generated, stored, and consumed. The Company deploys the controller within microgrids at commercial, healthcare, municipal, industrial and federal sites, and at a utility scale through the Next Utility Operating System®.

NextNRG also sells EV chargers, is advancing wireless in-motion charging, and operates one of the nation’s largest on-demand mobile fueling fleets through EzFill.

To learn more, visit www.nextnrg.com.

Forward-Looking Statements

This press release includes forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Any statement describing NextNRG’s goals, expectations, financial or other projections, intentions, or beliefs is a forward-looking statement and should be considered an at-risk statement. Words such as “expect,” “intends,” “will,” and similar expressions are intended to identify forward-looking statements. Such statements are subject to certain risks and uncertainties, including, but not limited to, those related to NextNRG’s business and macroeconomic and geopolitical events. These and other risks are described in NextNRG’s filings with the Securities and Exchange Commission from time to time.

NextNRG’s forward-looking statements involve assumptions that, if they never materialize or prove correct, could cause its results to differ materially from those expressed or implied by NextNRG. Although NextNRG’s forward-looking statements reflect the good faith judgment of NextNRG, these statements are based only on facts and factors currently known by NextNRG. Except as required by law, NextNRG undertakes no obligation to update these forward-looking statements for any reason. As a result, you are cautioned not to rely on these forward-looking statements.

Investor Relations Contact
NextNRG, Inc.
Sharon Cohen
SCohen@nextnrg.com

Media Contact
HCM for NextNRG
nextnrg@hannahcranstonmedia.com

Patent No. US 12,633,155 B1 covers deep-learning methods that automatically count vehicle occupants at highway speed, addressing a long-standing enforcement gap for transportation agencies

SALT LAKE CITY, Sept. 15, 2026 (GLOBE NEWSWIRE) — OMNIQ CORP. (OTCQB: OMQS) (“OMNIQ” or the “Company”), a leading provider of AI-based computer vision solutions, today announced that the U.S. Patent and Trademark Office has granted U.S. Patent No. 12,633,155 B1, titled “HOV detection system using multiband line-scan imagery.” The application was originally filed in 2020 and names OMNIQ’s Yoram Hofman as inventor.

The patent covers methods and systems for automatically determining the number of occupants inside a moving vehicle. As a vehicle crosses a detection line, roadside cameras capture line-scan images in two separate infrared bands. Because human skin reflects infrared light differently than vehicle interiors, seats, and clothing, comparing the two bands increases contrast on occupants’ faces. Deep-learning networks then locate the vehicle’s windows, identify faces within them, and validate the count across front and side views. The system pairs the occupancy count with license plate recognition (LPR) and, consistent with privacy requirements, blurs occupants’ faces in the evidentiary images it produces.

Economic Context

A representative deployment of the Company’s patented HOV enforcement technology could generate approximately $1.6 million in annual revenue. Based on the Company’s assessment of comparable deployment opportunities nationwide, the total annual U.S. addressable market is estimated at approximately $218 million. The estimate is based on approximately 136 addressable HOV and high occupancy toll facilities nationwide, after excluding jurisdictions where automated vehicle occupancy enforcement is legally restricted. The Federal Highway Administration identified 145 HOV and high occupancy toll facilities across the United States, providing an established infrastructure base for potential deployment.

“Our machine vision platform is already counting, identifying, and classifying vehicles in the field every day. This patent protects the next layer, seeing accurately inside the vehicle, at speed, day or night,” said Shai Lustgarten, CEO of OMNIQ. “Agencies have been asking for a reliable way to enforce occupancy requirements without putting officers on the shoulder of a freeway. We believe the methods protected by this patent are a credible answer, and we intend to continue investing in the intellectual property that differentiates our technology.”

The problem it addresses

HOV, carpool, and express lanes are among the primary tools transportation agencies use to manage congestion without building new road capacity. Their effectiveness depends on compliance, and compliance is difficult to enforce. Manual enforcement requires an officer to visually count occupants in vehicles traveling at highway speed, then execute a traffic stop, frequently on a shoulder with limited safe pull-off space.

The consequences are measurable. As cited in the patent’s background, the California Highway Patrol has indicated violation rates reaching as much as 39% of vehicles in a diamond lane during peak commute hours, with local transportation experts estimating an average of 19% to 24%. Every violating vehicle represents both degraded travel-time performance for compliant carpoolers and, on tolled express lanes, uncollected revenue.

Occupancy verification is also a requirement adjacent to markets that OMNIQ already serves, including tolling, border crossings, airport curbside and rideshare management, and controlled-access facilities, all of which rely on the same underlying vehicle-recognition stack.

How OMNIQ uses the technology today

The occupancy-detection methods build directly on the machine vision platform OMNIQ has deployed commercially. OMNIQ’s vehicle recognition technology, which identifies license plate, make, color, and state, is in service across thousands of sites in the United States and three sites globally, in applications including toll roads and border crossings, airport rideshare and curbside operations, law enforcement, gateless parking, and critical infrastructure access control.

The patented occupancy detection technology is already deployed at two active U.S. and one international site. These deployments provide real-world validation of the technology under live traffic conditions.

ABOUT OMNIQ
OMNIQ CORP. (or omniQ) uses patented and proprietary artificial intelligence (AI) technology to deliver machine vision image processing solutions, including data collection, real-time surveillance, and monitoring for supply chain management, homeland security, public safety, traffic & parking management, and access control applications.

The technology and services we provide help our clients move people, assets, and data safely and securely through airports, warehouses, schools, national borders, and many other applications and environments.

Our principal solutions include hardware, software, communications, automated management services, technical services, and support. Our highly tenured team of professionals has the knowledge and expertise to simplify the integration process for our customers. We deliver practical problem-solving solutions backed by numerous customer references.

Privacy and Data Security Commitment

OMNIQ solutions are built to meet the privacy and data protection requirements of the agencies that use them. Data is processed and stored in a private network, and access is limited to authorized personnel at the contracting agency. Data is retained and purged according to the agency’s policy and applicable state law. OMNIQ does not sell plate data or share it with third parties for commercial purposes.

For more information about OMNIQ Corp. and its innovative solutions, please visit www.omniq.com.

INFORMATION ABOUT FORWARD LOOKING STATEMENTS

“Safe Harbor” Statement under the Private Securities Litigation Reform Act of 1995. Statements in this press release relating to plans, strategies, economic performance and trends, projections of results of specific activities or investments, and other statements that are not descriptions of historical facts may be forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934.

This release contains “forward-looking statements” that include information relating to future events and future financial and operating performance. The words “anticipate,” “may,” “would,” “will,” “expect,” “estimate,” “can,” “believe,” “potential” and similar expressions and variations thereof are intended to identify forward-looking statements. Forward-looking statements should not be read as a guarantee of future performance or results and will not necessarily be accurate indications of the times at, or by, which that performance or those results will be achieved. Forward-looking statements are based on information available at the time they are made and/or management’s good faith belief as of that time with respect to future events and are subject to risks and uncertainties that could cause actual performance or results to differ materially from those expressed in or suggested by the forward-looking statements.

Important factors that could cause these differences include, but are not limited to: fluctuations in demand for the Company’s products, the introduction of new products, the Company’s ability to maintain customer and strategic business relationships, the impact of competitive products and pricing, growth in targeted markets, the adequacy of the Company’s liquidity and financial strength to support its growth, the Company’s ability to manage credit and debt structures from vendors, debt holders and secured lenders, the Company’s ability to successfully integrate its acquisitions, and other information that may be detailed from time-to-time in OMNIQ Corp.’s filings with the United States Securities and Exchange Commission. Examples of such forward-looking statements in this release include, among others, statements regarding revenue growth, driving sales, operational and financial initiatives, cost reduction and profitability, and simplification of operations. For a more detailed description of the risk factors and uncertainties affecting OMNIQ Corp., please refer to the Company’s recent Securities and Exchange Commission filings, which are available at SEC.gov. OMNIQ Corp. undertakes no obligation to publicly update or revise any forward-looking statements, whether as a result of new information, future events, or otherwise, unless otherwise required by law.

Contact

Company

IR@OMNIQ.COM

HAYDEN IR:
Brett Maas
(646) 536-7331
brett@haydenir.com

James Carbonara
(646)-755-7412
james@haydenir.com

LAS VEGAS, NV, Sept. 15, 2026 (GLOBE NEWSWIRE) — Avaí Bio, Inc. (OTCQB: AVAI) (“Avaí” or the “Company”), an emerging biotechnology company developing transformative cell-based therapies for diabetes, age-related disorders, and anti-aging, today announced, together with its joint venture partner and global biotechnology company Austrianova, the successful completion of comprehensive adventitious agent and viral testing of its GMP Master Cell Bank (MCB), from which its Working Cell Bank (WCB) was recently established. With the testing completed and the WCB now successfully established, Avaí Bio and Austrianova have completed an important milestone in the development of the Company’s genetically modified α-Klotho-producing cell line. 

The testing confirmed that the MCB, and in turn, the WCB are free of a broad range of potentially contaminating viruses and other adventitious agents. The testing included more than 30 viruses, including significant human and animal pathogens such as human immunodeficiency virus (HIV), simian immunodeficiency virus (SIV), human cytomegalovirus (HCMV), and hepatitis B and C viruses. Additional testing confirmed the absence of other potential contaminants, including bacteria, mycoplasma, fungi, and yeast. 

The testing was conducted by an experienced, accredited third-party laboratory in accordance with applicable industry guidelines, including those established by the U.S. Food and Drug Administration (FDA). 

The completion of this testing represents an important step in the development and characterization of the Company’s α-Klotho-producing cell line. The cells, which were in-licensed from Klothea Bio, have been genetically modified to overexpress α-Klotho, a protein associated with healthy aging and protection against age-related disease. 

Klothonova, the joint venture company formed by Avaí Bio and Austrianova, is now focused on further characterization of the Klotho-producing cells and on using the WCB to establish optimal production parameters for the development of the Cell-in-a-Box® encapsulated cell product. 

“We are pleased to announce the successful completion of this important testing milestone,” said Chris Winter, Chief Executive Officer of Avaí Bio. “The results provide additional confirmation of the safety and quality of our Master and Working Cell Banks and allow us, together with our partner, to advance the next stages of development. We remain focused on progressing toward our goal of developing long-term, safe and effective cell-based therapies for healthy aging and longevity.” 

Dr. Brian Salmons, Chief Executive Officer of Austrianova, added, “Comprehensive testing of cell banks for viruses and other adventitious agents is an essential component of biomanufacturing and an important prerequisite for advancing cell-based products toward clinical development. We are pleased that the independently conducted testing confirmed that the MCB, and by default, the WCB were negative for all viruses included in the testing panel. With this milestone completed, we are advancing toward the next steps in the development and production of the Cell-in-a-Box® encapsulated clinical product.” 

This latest milestone follows the joint venture agreement signed in September 2025, which established Klothonova as a Nevada-based company equally owned by Avaí Bio and Austrianova’s affiliate, SG Austria Pte. Ltd. The joint venture was established to develop a sustainable approach to the production and delivery of α-Klotho—often referred to as the “longevity protein,” a key regulatory protein that is well documented for its anti-aging and protective effects on organs—in patients using Cell-in-a-Box® encapsulated cell-based therapies. 

About Avaí Bio, Inc. 

Avaí Bio, Inc. is an emerging biotechnology company focused on identifying genetically modified cell lines, and through joint venture and licensing agreements developing innovative cell-based therapies. 

About Austrianova (SGAustria Pte. Ltd.) 

Austrianova, based in Singapore, is a leading biotechnology company specializing in cell encapsulation, GMP-grade cell products, and cell line development, backed by over 50 peer-reviewed publications and partnerships with global pharmaceutical and biotech companies. 

More information about Avaí Bio can be found at https://www.avaibio.com  

More information about Austrianova can be found at https://austrianova.com 

You can also follow us on social media at: 

https://x.com/AvaiBio 

https://www.facebook.com/AvaiBio 

https://www.facebook.com/Austrianova 

Forward-Looking Statements 

Certain statements contained in this press release may constitute “forward-looking statements.”  Forward-looking statements provide current expectations of future events based on certain assumptions and include any statement that does not directly relate to any historical or current fact.  Actual results may differ materially from those indicated by such forward-looking statements because of various important factors as disclosed in our filings with the Securities and Exchange Commission located at their website (http://www.sec.gov).  In addition to these factors, actual future performance, outcomes, and results may differ materially because of more general factors including (without limitation) general industry and market conditions and growth rates, economic conditions, governmental and public policy changes, the Company’s ability to raise capital on acceptable terms, if at all, the Company’s successful development of its products and the integration into its existing products and the commercial acceptance of the Company’s products.  The forward-looking statements included in this press release represent the Company’s views as of the date of this press release, and these views could change. However, while the Company may elect to update these forward-looking statements at some point in the future, the Company specifically disclaims any obligation to do so. These forward-looking statements should not be relied upon as representing the Company’s views as of any date after the date of the press release.

CONTACT: Avaí Bio, Inc. 

info@avaibio.com 

ERNA-201 demonstrated encouraging disease-modifying activity in the industry-standard collagen-induced arthritis model, providing meaningful proof-of-concept for Ernexa’s engineered synthetic iMSC platform beyond oncology

Positive ERNA-201 findings add to a growing body of preclinical evidence supporting the versatility of Ernexa’s synthetic iMSC platform and its ability to deliver engineered therapeutic factors in disease

Company is concentrating near-term resources on ERNA-101 while broadening its oncology strategy and advancing next-generation iMSC candidates across additional high-need cancer indications

ERNA-201 remains an important platform asset with demonstrated preclinical proof-of-concept, preserving future development and strategic optionality

CAMBRIDGE, Mass., Sept. 15, 2026 (GLOBE NEWSWIRE) — Ernexa Therapeutics (Nasdaq: ERNA), an industry innovator developing novel cell therapies for the treatment of advanced cancers, today announced positive preliminary preclinical results for ERNA-201, its synthetic, allogeneic induced mesenchymal stem cell (iMSC) therapy engineered to express anti-inflammatory factors, while outlining a sharpened oncology strategy designed to accelerate the Company’s transition into the clinic and expand the long-term potential of its proprietary synthetic iMSC platform.

In preliminary studies using the collagen-induced arthritis (CIA) model, an industry-standard preclinical model for rheumatoid arthritis and inflammatory joint disease, several ERNA-201 lead candidates demonstrated reductions in disease severity relative to untreated controls, including improvements in clinical arthritis scores consistent with the therapy’s intended anti-inflammatory mechanism of action.

Ernexa believes these results represent an important scientific milestone: ERNA-201 demonstrated meaningful preclinical proof-of-concept in inflammatory disease, providing additional evidence that the Company’s engineered iMSC platform can be programmed to deliver therapeutically relevant factors across distinct disease settings.

With this platform validation in hand, Ernexa is concentrating its near-term capital and operational resources on what management believes represents the Company’s most immediate opportunity to create value for patients and shareholders: advancing ERNA-101 into a first-in-human clinical study in platinum-resistant ovarian cancer (PROC).

Importantly, the decision to prioritize ERNA-101 does not reflect a change in Ernexa’s conviction in ERNA-201 or its underlying biology. Rather, following the positive ERNA-201 proof-of-concept results, the Company believes it has reached an appropriate point to preserve the program while directing near-term resources toward achieving clinical validation of its platform in oncology.

“We believe the ERNA-201 results are an important validation of both the program and the broader potential of our synthetic iMSC platform,” said Sanjeev Luther, President and Chief Executive Officer of Ernexa Therapeutics. “ERNA-201 did what we wanted to see at this stage: it generated an encouraging proof-of-concept signal in an established inflammatory disease model and demonstrated the potential to engineer our iMSCs for therapeutic activity beyond cancer. That success gives us the confidence to preserve the significant future opportunity represented by ERNA-201 while concentrating our resources on the milestone directly ahead of us, bringing ERNA-101 into the clinic.”

Mr. Luther continued, “Our objective is bigger than advancing a single candidate. We are building a differentiated oncology company around a scalable, off-the-shelf cell therapy platform. With ERNA-101 on track for FDA IND submission before year end, we believe Ernexa is approaching a potentially defining inflection point. We intend to execute against that milestone with urgency while broadening our oncology pipeline and identifying additional cancers where our platform could make a meaningful difference.”

ERNA-201: Positive Data Strengthen Validation of Ernexa’s iMSC Platform

ERNA-201 is engineered to express anti-inflammatory factors designed to target inflammation and treat autoimmune disease. In completed preliminary studies, ERNA-201 was evaluated in the CIA model, which is widely used to assess potential therapies for rheumatoid arthritis and other inflammatory joint diseases.

Mice treated with several ERNA-201 lead candidates demonstrated reductions in disease severity relative to untreated controls, including improvements in clinical arthritis scores. Ernexa believes the findings are consistent with the candidate’s intended anti-inflammatory mechanism and provide meaningful proof-of-concept support for the use of synthetic, cytokine-engineered iMSCs in inflammatory and autoimmune disease.

“Seeing disease-modifying activity from ERNA-201 in the collagen-induced arthritis model is an encouraging scientific result,” said Robert H. Pierce, M.D., Chief Scientific Officer of Ernexa Therapeutics. “These findings support the underlying thesis that engineered iMSCs can serve as a versatile therapeutic delivery platform. We designed ERNA-201 to deliver anti-inflammatory factors in disease, and the preliminary activity we observed is consistent with that objective. From a scientific perspective, these data increase our confidence in the program and provide another important validation point for the broader platform.”

The ERNA-201 results are particularly important to Ernexa because the program employs the same fundamental synthetic iMSC platform architecture that underpins the Company’s broader pipeline. While ERNA-201 is engineered for anti-inflammatory activity and ERNA-101 is engineered to stimulate an immune response against cancer, both programs demonstrate the potential versatility of an allogeneic, scalable cell platform that can be engineered for distinct therapeutic purposes.

Building Momentum Toward the Clinic: ERNA-101 Advancing Toward Planned IND Submission in Q4 2026

With ERNA-201 generating positive preliminary proof-of-concept data, Ernexa is prioritizing the next major milestone in the Company’s evolution: advancing ERNA-101 toward a planned IND submission for a first-in-human clinical study in platinum-resistant ovarian cancer.

ERNA-101 is Ernexa’s lead oncology cell therapy candidate, engineered to express an IL-7/IL-15 fusion cytokine designed to activate and regulate the immune system’s response to recognize and attack cancer cells.

The Company is focused on advancing ERNA-101 toward a planned IND submission in the fourth quarter of 2026. Ernexa believes achieving this milestone would represent an important step toward the Company’s transition from a preclinical development company to a clinical-stage oncology company and the generation of human clinical evidence necessary to evaluate the therapeutic potential of its platform.

Clinical data from the ERNA-101 PROC study are expected in Q4 2027, providing the Company with a series of potential clinical and operational milestones over the coming 12–18 months.

A Focused Oncology Strategy Built Around One Scalable Platform

Ernexa’s strategy extends beyond a single indication or product candidate. The Company’s proprietary platform begins with induced pluripotent stem cells (iPSCs), which are engineered and transformed into synthetic induced mesenchymal stem cells. The resulting allogeneic iMSCs are designed to provide a scalable, off-the-shelf therapeutic approach without the need for patient-specific cell harvesting.

Management believes this architecture creates the potential to engineer iMSCs with different therapeutic factors and apply the platform across multiple diseases. The positive preliminary ERNA-201 findings provide additional support for that platform thesis, while ERNA-101 now represents the Company’s most advanced opportunity to demonstrate its potential in patients.

As Ernexa moves toward the clinic, the Company intends to broaden the scope of its oncology program by evaluating additional high-need cancer indications and advancing next-generation iMSC candidates designed to build on the Company’s existing scientific and manufacturing capabilities.

The Company will prioritize opportunities based on scientific rationale, unmet patient need, commercial potential and capital efficiency, including opportunities that may be pursued internally or through strategic collaborations.

Disciplined Capital Allocation: Advancing the Nearest Value-Creating Milestones

Following the encouraging ERNA-201 results, Ernexa has elected to pause additional preclinical development expenditures on ERNA-201 at this time and preserve the program while concentrating near-term resources on ERNA-101 and the expansion of its oncology pipeline.

The decision is a capital allocation priority rather than a scientific decision to discontinue ERNA-201. The Company believes the positive preliminary results provide a foundation from which ERNA-201 could potentially be advanced in the future as resources, strategic priorities and development opportunities warrant.

“We have achieved an important objective with ERNA-201 by generating encouraging proof-of-concept data,” Luther said. “The question for us now is not whether we believe in the program. We do. The question is where each incremental dollar and each hour of our team’s effort can have the greatest impact today. With ERNA-101 approaching the clinic, we believe concentrating resources behind first-patient dosing and expanding our oncology opportunity is the most disciplined path forward.”

“We are preserving ERNA-201’s future potential while accelerating the program that is closest to human clinical validation. We believe that the combination of scientific validation, disciplined execution and a clear path into the clinic positions Ernexa for an important next chapter.”

Multiple Potential Catalysts Ahead

Over the coming 12–18 months, Ernexa intends to:

• Submit ERNA-101 IND in Q4 2026 for a first-in-human clinical study in platinum-resistant ovarian cancer;
• Generate clinical data from the ERNA-101 PROC program, currently expected in Q4 2027;
• Continue generating translational and preclinical evidence designed to strengthen validation of the synthetic iMSC platform;
• Evaluate opportunities to expand the platform into additional high-need oncology indications;
• Advance next-generation synthetic iMSC oncology candidates;
• Explore strategic collaborations that could accelerate or broaden the application of Ernexa’s technology; and
• Maintain disciplined capital allocation focused on milestones management believes can create the greatest value for patients and shareholders.

“We believe we are entering one of the most consequential periods in Ernexa’s development,” Luther concluded. “ERNA-201 has provided encouraging evidence that our engineering approach can translate into therapeutic activity in a well-established disease model. ERNA-101 is approaching the clinic. And behind it is a platform we believe can be engineered and deployed against multiple high-need cancers. Our focus now is execution, reaching the clinic, generating human data and building a broader oncology pipeline capable of creating sustainable value.”

For more information about ERNA-101 and the Company’s development plans, visit www.ernexatx.com.

About Ernexa Therapeutics

Ernexa Therapeutics (NASDAQ: ERNA) is developing innovative cell therapies for the treatment of advanced cancers. Ernexa’s core technology focuses on engineering induced pluripotent stem cells (iPSCs) and transforming them into induced mesenchymal stem cells (iMSCs). Ernexa’s allogeneic synthetic iMSCs provide a scalable, off-the-shelf treatment solution, without needing patient-specific cell harvesting.

ERNA-101 is the company’s lead cell therapy product, designed to activate and regulate the immune system’s response to recognize and attack cancer cells. The company’s initial focus is to develop ERNA-101 for the treatment of ovarian cancer, with the potential to address multiple difficult-to-treat solid tumors.

For more information, visit www.ernexatx.com.

Forward-Looking Statements

This press release contains forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended, which are intended to be covered by the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. Forward-looking statements, in some cases, can be identified by terms such as “believe,” “may,” “will,” “estimate,” “continue,” “anticipate,” “design,” “intend,” “expect,” “could,” “plan,” “potential,” “predict,” “seek,” “should,” “would,” “contemplate,” “project,” “target,” “objective,” or the negative version of these words and similar expressions. Forward-looking statements involve known and unknown risks, uncertainties and other factors that may cause Ernexa’s actual results, performance or achievements to be materially different from future results, performance or achievements expressed or implied by the forward-looking statements in this press release, including, without limitation, risks and uncertainties related to: the Company’s ability to advance ERNA-101 toward and submit an IND application to the FDA, including the planned submission in Q4 2026; the timing, design and outcomes of the planned first-in-human clinical study of ERNA-101 in platinum-resistant ovarian cancer, including the expected availability of clinical data in Q4 2027; the Company’s ability to transition from a preclinical-stage company to a clinical-stage company; expectations regarding the versatility and therapeutic potential of the Company’s synthetic iMSC platform, including its ability to be engineered for distinct therapeutic purposes across oncology and other disease areas; the Company’s plans to broaden its oncology pipeline by evaluating additional high-need cancer indications and advancing next-generation iMSC candidates; the Company’s ability to identify, develop and advance additional product candidates; the Company’s capital allocation strategy, including the decision to pause additional preclinical development expenditures on ERNA-201 and concentrate near-term resources on ERNA-101 and oncology pipeline expansion; the potential for ERNA-201 to be advanced in the future; the Company’s ability to enter into strategic collaborations or partnerships; the sufficiency of the Company’s capital resources to fund planned operations and achieve anticipated milestones; the Company’s ability to obtain and maintain regulatory approvals for its product candidates; the Company’s ability to attract and retain qualified personnel; the Company’s ability to protect its intellectual property and proprietary technology; competition from other companies developing therapies for the same or similar indications; and general market, political and economic conditions. Forward-looking statements are based upon Ernexa’s current expectations and involve assumptions that may never materialize or may prove to be incorrect. All forward-looking statements are expressly qualified in their entirety by these cautionary statements. For a detailed description of Ernexa’s risks and uncertainties, you are encouraged to review its documents filed with the SEC including its recent filings on Form 8-K, Form 10-K and Form 10-Q. You are cautioned not to place undue reliance on forward-looking statements, which speak only as of the date on which they were made. Ernexa does not undertake any obligation to update the forward-looking statements contained herein to reflect events that occur or circumstances that exist after the date hereof, except as required by applicable law.

Media Contact
Sharon Golubchik
RAYNZ
sharon@raynzhealth.com

Investor Contact
Jenene Thomas
JTC Team, LLC
(908) 824-0775
ERNA@jtcir.com