Month: September 2026

 Repeat-dose GLP toxicology study showed no ERNA-101-related adverse findings across all dose levels tested, including no clinical pathology or histopathology findings; single-dose assessment showed no evidence of acute cytokine release

No teratoma formation observed in ERNA-101-treated animals through the six-month tumorigenicity in-life phase, addressing a fundamental safety consideration for an iPSC-derived cell therapy

Biodistribution study showed no significant ERNA-101 signal in tumor-free animals or non-tumor tissues, supporting ERNA-101’s tumor-homing delivery strategy

Encouraging safety results build on previously reported complete tumor clearance and durable survival in ovarian cancer models, strengthening the nonclinical foundation for ERNA-101

Core IND-enabling safety studies complete; GMP manufacturing underway; Company remains on track for planned Q4 2026 IND submission

CAMBRIDGE, Mass., Sept. 30, 2026 (GLOBE NEWSWIRE) — Ernexa Therapeutics (Nasdaq: ERNA), an industry innovator developing novel cell therapies for the treatment of advanced cancers, today announced highly encouraging results from three core Investigational New Drug (IND)-enabling safety studies of ERNA-101, its lead synthetic, allogeneic induced mesenchymal stromal cell (iMSC) therapy engineered to express an IL-7/IL-15 fusion cytokine.

Across repeat-dose GLP toxicology, tumorigenicity and biodistribution studies, ERNA-101 demonstrated a favorable nonclinical safety profile, with results addressing three critical questions as the Company prepares to advance the program toward first-in-human development:

• Repeat-dose safety: No ERNA-101-related adverse findings were observed at any dose level tested in a 50-day GLP toxicology study in tumor-bearing mice with an intact immune system.
• Tumorigenicity: No teratoma formation was observed in ERNA-101-treated animals through the six-month tumorigenicity in-life phase, addressing an important safety consideration for an iPSC-derived therapy.
• Biodistribution: No significant ERNA-101 signal was detected in tumor-free animals or non-tumor tissues, supporting ERNA-101’s design to home to tumors without taking up residence elsewhere in the body.

Importantly, the results add a critical safety dimension to previously reported ERNA-101 efficacy data demonstrating complete tumor clearance and durable long-term survival in preclinical ovarian cancer models when combined with PD-1 blockade. Together, Ernexa believes the efficacy, safety and biodistribution findings provide an increasingly comprehensive nonclinical foundation for advancing ERNA-101 toward the clinic.

“We believe these results represent one of the most important milestones in Ernexa’s history because the ERNA-101 story is now coming together across efficacy, safety and tumor-targeted delivery,” said Sanjeev Luther, President and Chief Executive Officer of Ernexa Therapeutics. “We have previously demonstrated compelling anti-tumor activity, including complete tumor clearance and durable survival in preclinical ovarian cancer models. Now, across three critical IND-enabling safety studies, we observed no ERNA-101-related adverse findings in our repeat-dose GLP study, no teratoma formation through the six-month tumorigenicity in-life phase and no significant ERNA-101 signal in tumor-free animals or non-tumor tissues.”

“From a scientific perspective, these findings provide important support for the fundamental design of ERNA-101,” said Robert H. Pierce, M.D., Chief Scientific Officer of Ernexa Therapeutics. “Across repeat-dose toxicology, tumorigenicity and biodistribution, we are seeing encouraging results that strengthen the nonclinical foundation for advancing ERNA-101 toward the clinic.”

Luther continued, “In straightforward terms, these results support what we designed ERNA-101 to do: find the tumor, deliver powerful immune-enhancing cytokines where they are intended to work and limit unnecessary exposure elsewhere in the body. With our core safety studies complete, GMP manufacturing underway and our FDA Pre-IND meeting behind us, we remain on track for our planned IND submission in the fourth quarter of 2026. Our focus now is execution and moving ERNA-101 toward the milestone that matters most: treating our first patient.”

Repeat-Dose GLP Toxicology: No ERNA-101-Related Adverse Findings

In Ernexa’s pivotal 50-day GLP toxicology study, immunocompetent C57BL/6 mice with established ID8 ovarian tumors received ERNA-101 intraperitoneally once weekly for four doses at 0.33 × 10⁶, 1 × 10⁶ or 1 × 10⁷ cells per animal, compared with vehicle-treated controls.

The study was designed to evaluate ERNA-101 under conditions relevant to its planned clinical use, with tumor present, an intact immune system and repeat dosing.

Across all dose levels tested, there were:

• No ERNA-101-related changes in clinical pathology;
• No pathological evidence of treatment-related toxicity on microscopic evaluation by an independent board-certified veterinary pathologist; and
• No treatment-related differences in the incidence or timing of unscheduled deaths, all of which were attributed to progression of the underlying tumor.

What the data mean: ERNA-101 is engineered to deliver an IL-7/IL-15 fusion cytokine directly into the tumor microenvironment. Cytokines can powerfully activate the immune system, but systemic exposure can also cause significant toxicity. Ernexa designed ERNA-101 to use the natural tumor-homing properties of mesenchymal stromal cells to concentrate cytokine activity within tumors while limiting systemic exposure. The absence of ERNA-101-related toxicity in the repeat-dose study, together with the absence of acute cytokine release in the single-dose assessment, provides important support for that design strategy.

“A cytokine-armed cell therapy needs to be evaluated where its biology is active, in the presence of tumor and an intact immune system,” said Robert H. Pierce, M.D., Chief Scientific Officer of Ernexa Therapeutics. “That is what makes these results particularly encouraging. Across the repeat-dose study, we observed no ERNA-101-related adverse findings in clinical pathology or histopathology, and in the single-dose assessment, we observed no evidence of acute cytokine release. We believe the results support the fundamental concept behind ERNA-101: bring powerful immune activation to the tumor while limiting systemic exposure.”

Tumorigenicity: No Teratoma Formation Observed Through Six-Month In-Life Phase

Because ERNA-101 is derived from induced pluripotent stem cells, or iPSCs, tumorigenicity is an important component of its nonclinical safety assessment. Specifically, the studies evaluate whether the final differentiated ERNA-101 cell product could form unwanted tumors known as teratomas.

Ernexa has completed a three-month tumorigenicity study and the in-life phase of a six-month tumorigenicity study in immunocompromised NSG mice. No gross evidence of teratoma formation was observed in ERNA-101-treated groups.

Histopathologic assessment confirmed the absence of tumor formation in the three-month study. Histopathologic evaluation of the six-month study is ongoing and is expected to be completed prior to IND submission.

What the data mean: For an iPSC-derived cell therapy, demonstrating that the final cell product does not form teratomas is a fundamental safety consideration. The absence of teratoma formation through the six-month in-life phase provides an encouraging answer to this important question as Ernexa prepares its IND package.

Biodistribution: No Significant ERNA-101 Signal in Tumor-Free Animals or Non-Tumor Tissues

Ernexa also completed a five-week biodistribution and persistence study designed to answer another straightforward but critical question: Where do ERNA-101 cells go after they are administered?

ERNA-101 was evaluated in both tumor-bearing and tumor-free animals. Using highly sensitive digital droplet PCR (ddPCR) specific for ERNA-101, the Company found no significant ERNA-101 signal in non-tumor-bearing animals or non-tumor-containing tissues.

The findings are consistent with the intrinsic tumor-homing properties of mesenchymal stromal cells and prior studies in which ERNA-101 cells were detected within tumors.

What the data mean: Ernexa designed ERNA-101 to home to tumors, deliver its immune-enhancing payload and avoid taking up residence elsewhere in the body. The biodistribution results provide important support for that targeted-delivery strategy.

“Biodistribution goes directly to the heart of the ERNA-101 thesis,” Pierce said. “Put simply, we want the cells to go to the tumor, deliver their payload and not take up residence where they do not belong. Finding no significant ERNA-101 signal in tumor-free animals or non-tumor tissues is exactly the type of biodistribution profile we hoped to see and provides important support for the targeted delivery concept underlying our platform.”

Efficacy + Safety + Tumor-Homing: Building a More Complete ERNA-101 Profile

The newly reported safety results build on previously reported ERNA-101 preclinical efficacy findings.

In ovarian cancer models, ERNA-101 remodeled the tumor microenvironment from immunosuppressive to immune-activated and increased infiltration of CD4+ and CD8+ T cells. When combined with PD-1 blockade, ERNA-101 achieved a high rate of complete tumor clearance and durable long-term survival, findings that were validated in independent studies.

In simple terms, the preclinical development program has now begun to address three fundamental questions:

Can ERNA-101 mediate tumor clearance?
Preclinical efficacy studies demonstrated compelling anti-tumor activity, including complete tumor clearance and durable survival in ovarian cancer models.

Can ERNA-101 potentially do so with an acceptable safety profile?
The core IND-enabling studies showed no ERNA-101-related adverse findings in repeat-dose GLP toxicology and no observed teratoma formation through the six-month tumorigenicity in-life phase.

Does ERNA-101 go where it is designed to go?
Biodistribution studies showed no significant ERNA-101 signal in tumor-free animals or non-tumor tissues.

“We believe the significance is in the totality of the data,” Luther said. “Efficacy, safety and tumor-homing are not separate stories, they are interconnected parts of the same ERNA-101 thesis. The preclinical evidence generated to date is giving us encouraging answers across all three dimensions. That strengthens our conviction in the program as we prepare for the transition from preclinical development into the clinic.”

Advancing Toward a Planned Q4 2026 IND

Completion of the core IND-enabling safety studies represents another major step in Ernexa’s planned transition toward becoming a clinical-stage oncology company.

The Company has completed its FDA Pre-IND meeting, completed its core IND-enabling safety studies and is advancing clinical-grade GMP manufacturing of ERNA-101.

Ernexa remains on track to submit an IND for ERNA-101 in Q4 2026 for a first-in-human clinical study in platinum-resistant ovarian cancer. Subject to IND clearance, the Company intends to initiate the study and dose the first patient, with initial clinical data currently expected in Q4 2027.

“There is a point in the development of every potentially important new therapy when the question begins to change,” Luther concluded. “The question is no longer simply whether the science looks promising. It becomes whether you have built the foundation necessary to take that science into patients. With compelling preclinical efficacy, encouraging safety results, our core IND-enabling studies complete and manufacturing underway, we believe Ernexa is approaching that moment.”

Mr. Luther continued, “Our objective now is clear: execute the IND submission, advance ERNA-101 into the clinic and begin determining whether the promise we have observed in preclinical models can translate into meaningful benefit for patients. For women facing platinum-resistant ovarian cancer, better treatment options are urgently needed. That need gives purpose to every milestone we achieve and urgency to everything that comes next.”

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 stromal 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: progress and possible outcomes of the Company’s lead research project, ERNA-101, and future research projects. 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

A chart accompanying this announcement is available at https://www.globenewswire.com/NewsRoom/AttachmentNg/912c23d8-20bf-4df7-8861-e63dcd5874fd

PHOENIX, Sept. 30, 2026 (GLOBE NEWSWIRE) — Global Water Resources, Inc. (NASDAQ: GWRS), a pure-play water resource management company, has declared under its dividend policy a monthly cash dividend in the amount of $0.02533 per common share (an annual dividend rate of $0.30396 per share).

The dividend will be payable on October 30, 2026, to holders of record at the close of business on October 16, 2026.

About Global Water Resources

Global Water Resources, Inc. is a leading water resource management company that owns and operates 39 systems which provide water, wastewater, and recycled water service. The company’s service areas are located primarily in growth corridors around metropolitan Phoenix and Tucson. Global Water recycles over 1 billion gallons of water annually with 19.9 billion gallons recycled since 2004.

The company has been recognized for its highly effective implementation of Total Water Management (TWM). TWM is an integrated approach to managing the entire water cycle that involves owning and operating water, wastewater and recycled water utilities within the same geographic area in order to maximize the beneficial use of recycled water. It enables smart water management programs such as remote metering infrastructure and other advanced technologies, rate designs, and incentives that result in real conservation. TWM helps protect water supplies in water-scarce areas experiencing population growth.

Global Water has received numerous industry awards, including national recognition as a ‘Utility of the Future Today’ for its superior water reuse practices by a national consortium of water and conservation organizations led by the Water Environment Federation (WEF). The company also received Cityworks’ Excellence in Departmental Practice Award for demonstrating leadership and creativity in applying public asset management strategies to daily operations and long-term planning.

To learn more, visit www.gwresources.com.

Company Contact:
Michael Liebman
CFO and EVP
Tel (480) 999-5104
Email Contact

Investor Relations Contact:
Ron Both or Grant Stude
Encore Investor Relations
Tel (949) 432-7450
Email Contact

• In a year-long functional magnetic resonance imaging (fMRI) study – a non-invasive method to measure brain activity during specific tasks – CagriSema changed how the brain reacted to tempting, high-calorie foods in areas linked to cravings, pleasure, and self-control in people living with overweight or obesity¹
• In adults with type 2 diabetes, CagriSema reduced harmful fat around abdominal organs, including the liver and pancreas. Early findings also suggest that bone health was maintained despite substantial weight loss^2,3
• Together, these findings suggest CagriSema may address underlying factors of obesity and type 2 diabetes in the brain and multiple organs and tissues, including bones, not only weight and blood sugar levels^1-3

Bagsværd, Denmark, 30 September 2026 – Novo Nordisk today announced new data on how CagriSema works inside both the brain and body, presented at the European Association for the Study of Diabetes (EASD) Annual Meeting 2026.

In a 52-week functional magnetic resonance imaging (fMRI) study, a brain scan technique that shows how the brain responds to cues, in adults with overweight or obesity, CagriSema modified brain responses to high-calorie food cues in regions linked to cravings, reward, sensory processing and behavioural control. Additionally, CagriSema substantially improved eating behaviour, reduced ‘food noise’, cravings, hunger, appetite, and food-related thoughts and improved craving control after both 22 and 52 weeks of treatment. In the study, also awarded a Best Abstract Award at EASD 2026, the improvements were also associated with a 22.4% reduction in body weight versus placebo at 52 weeks (estimated treatment difference at 52 weeks, p<0.0001).¹ Overall, the results suggest CagriSema may help address biological drivers that make sustained weight management difficult, including hunger, cravings and food preoccupation, not just calorie intake.

Separately, in a diabetes MRI sub-study, which evaluated whole body metabolic effects in the phase 3a REIMAGINE 1 trial in adults with early type 2 diabetes, CagriSema 2.4 mg/2.4 mg produced significant reductions in fat in the abdomen and around the liver and pancreas fat versus placebo, alongside a 14.3% body-weight reduction at week 40.² In addition, a post hoc analysis of bone markers of the phase 3 REIMAGINE 2 trial in adults with inadequately controlled type 2 diabetes showed signs of healthy balance in bone maintenance alongside a 14.2% body-weight reduction with CagriSema 2.4 mg/2.4 mg at week 68, providing what the study authors describe as “preliminary reassurance regarding bone changes with CagriSema in type 2 diabetes”.³

“For many people with overweight or obesity, we know that ‘food noise’ is an ongoing challenge to achieving health goals. Based on this brain scan (fMRI) data, we are encouraged by the potential of CagriSema to help reduce measurable ‘food noise’ coupled with a 22.4% reduction in body weight after 52 weeks,” said Martin Holst Lange, executive vice president, chief scientific officer and head of Research & Development at Novo. “At the same time, people living with overweight, obesity and type 2 diabetes are increasingly looking beyond the amount of weight lost to the quality of that weight loss. The data presented at EASD 2026 add to emerging evidence that the amylin component of CagriSema may influence disease biology across the brain and multiple organs beyond weight loss alone.”

Taken together, the three studies suggest investigational CagriSema may act on obesity and type 2 diabetes through coordinated effects on eating behaviour, fat levels in and around the organs, and bone remodelling – mechanisms that extend well beyond weight reduction itself.

“What is striking about this behavioural and brain fMRI data is that, after 52 weeks, across all measures of appetite and eating behaviour, people with overweight and obesity had substantially reduced food cravings and sustained changes in the brain response to viewing pictures of high-calorie foods,” said Professor Tony Goldstone, Clinical Professor in PsychoNeuroEndocrinology and Consultant Endocrinologist, Imperial College London. “This was coupled with reduced energy intake and body weight, showing the association between tackling ‘food noise’ and successful and sustained weight loss.”

CagriSema is Novo Nordisk’s next-generation investigational obesity and diabetes treatment. Novo Nordisk submitted an NDA for obesity to the US FDA and Health Canada in December 2025. In 2026, High-dose CagriSema 2.4 mg/7.2 mg, an efficacy and safety phase 3 trial, was initiated in adults with obesity.

Obesity and type 2 diabetes remain among the largest, most under-treated chronic disease burdens globally. According to the World Health Organization, more than one billion people worldwide are now living with obesity, and the International Diabetes Federation estimates that approximately 589 million adults are living with diabetes, the majority with type 2 diabetes.⁴^,5

Beyond weight itself, obesity drives risk for cardiovascular disease, metabolic dysfunction-associated steatotic liver disease (MASLD), chronic kidney disease and multiple cancers.⁶ Many people describe persistent thoughts about food – sometimes called ‘food noise’ – as a barrier to sustained weight loss, and current therapies have historically been evaluated primarily on scale weight rather than on the underlying drivers of eating behaviour or on where fat is stored in the body. Ectopic fat — fat accumulated in the liver, pancreas and around abdominal organs — is a key contributor to insulin resistance and progression of type 2 diabetes.⁷

The CagriSema studies presented at EASD 2026 are designed to address these gaps by measuring how the therapy affects the brain, behaviour, and body — not weight alone.

About CagriSema
Once-weekly subcutaneous CagriSema is being investigated by Novo as a treatment for adults with overweight or obesity (REDEFINE programme) and as a treatment for adults with type 2 diabetes (REIMAGINE programme). CagriSema is a fixed-dose combination of a long-acting amylin receptor agonist, cagrilintide, and a GLP-1 receptor agonist, semaglutide.

Novo filed a New Drug Application with the U.S. Food and Drug Administration in December 2025 for CagriSema for weight management, demonstrating the company’s commitment to obesity innovation. A decision is expected in Q4 2026.

About the REDEFINE programme
REDEFINE is a phase 3 clinical development programme with once-weekly subcutaneous CagriSema in obesity. The global clinical trial programme includes two pivotal phase 3 trials that enrolled approximately 4,600 adults with overweight or obesity. The phase 3 trial programme includes:

• REDEFINE 1 – a 68-week efficacy and safety phase 3 trial of once-weekly CagriSema 2.4 mg/2.4 mg, cagrilintide 2.4 mg and semaglutide 2.4 mg versus placebo in 3,417 adults with obesity or overweight with one or more comorbidities and without type 2 diabetes.
• REDEFINE 2 – a 68-week efficacy and safety phase 3 trial of once-weekly CagriSema 2.4 mg/2.4 mg versus placebo in 1,206 adults with type 2 diabetes and either obesity or overweight.
• REDEFINE 3 – an event-driven cardiovascular outcomes phase 3 trial of once-weekly CagriSema 2.4 mg/2.4 mg versus placebo in 7,000 adults with established cardiovascular disease with or without type 2 diabetes.
• REDEFINE 8 – a 104-week efficacy and safety phase 3 trial of once-weekly CagriSema 2.4 mg/2.4 mg versus placebo in 400 adults with obesity, including assessments on body composition. The trial includes a 52-week extension phase investigating maintenance of weight loss with CagriSema 2.4 mg/2.4 mg or a dose-tapering algorithm.
• REDEFINE 9 – a 68-week efficacy and safety phase 3 trial of once-weekly CagriSema 1.7 mg/1.7 mg and CagriSema 1.0 mg/1.0 mg versus placebo in 300 adults with overweight or obesity.
• REDEFINE 11 – an 80-week efficacy and safety phase 3 trial of once-weekly CagriSema 2.4 mg/2.4 mg versus placebo in 600 adults with obesity. The trial includes an 80-week extension phase investigating the maintenance of weight loss.
• High-dose CagriSema 2.4 mg/7.2 mg, an efficacy and safety phase 3 trial, was initiated in adults with obesity in 2026.

About the REIMAGINE programme
REIMAGINE is a phase 3 clinical development programme with once-weekly subcutaneous CagriSema in type 2 diabetes. The global clinical trial programme consists of several phase 3 trials. REIMAGINE 1 was a 40-week efficacy and safety phase 3 trial of CagriSema 2.4 mg/2.4 mg and 1 mg/1 mg once-weekly versus placebo in 189 adults with type 2 diabetes inadequately controlled on diet and exercise. REIMAGINE 2 was a 68-week efficacy and safety phase 3 trial of CagriSema 2.4 mg/2.4 mg and 1 mg/1 mg once-weekly versus semaglutide 2.4 mg, semaglutide 1 mg, cagrilintide 2.4 mg, and placebo in 2,713 adults with type 2 diabetes inadequately controlled with metformin with or without an SGLT2 inhibitor. REIMAGINE 3 was a 40-week efficacy and safety phase 3 trial of CagriSema 2.4 mg/2.4 mg and 1 mg/1 mg once-weekly versus placebo in 274 adults with type 2 diabetes as an add-on to once-daily basal insulin with or without metformin.

Additionally, the REIMAGINE 4 and REIMAGINE 5 trials evaluated CagriSema 2.4 mg/2.4 mg and 1 mg/1 mg, respectively, versus tirzepatide in adults with type 2 diabetes on standard of care.

Novo is the global healthcare company that believes lasting health starts now. For over a century, we’ve combined leading scientific expertise with a deep understanding of people’s lives. We develop treatments and support that help millions of people make progress they can see, feel and sustain now and in the future. Every day, over 67,000 employees around the world advance our purpose to drive change for lasting health. Through our partnerships, programmes and investments, we’re working to prevent disease, expand access to treatments and reduce our environmental impact to help even more people live healthier lives. For more information, visit novonordisk.com and follow us on Instagram, LinkedIn, TikTok, Facebook, X and YouTube.

Contacts for further information

Novo Media:
Ambre James-Brown +45 3079 9289 globalmedia@novonordisk.com	Liz Skrbkova (US) +1 609 917 0632 USMediaRelations@novonordisk.com
Novo Investors:
Michael Novod +45 3075 6050 nvno@novonordisk.com	Sina Meyer +45 3079 6656 azey@novonordisk.com
Christoffer Togo Solgaard-Tullin +45 3079 1471 cftu@novonordisk.com	Max Ung +45 3077 6414 mxun@novonordisk.com
Ida Schaap Melvold +45 3077 5649 idmg@novonordisk.com	Mads Berner Bruun +45 3075 2936 mbbz@novonordisk.com
Frederik Taylor Pitter (US) +1 609 613 0568 fptr@novonordisk.com	Alex Bruce (US) +1 640 230 0276 axeu@novonordisk.com

_______________________
References

1. Uhre VF, Alex M, Bak N, et al. Effects of CagriSema on appetite, eating behaviour and food cue reactivity using functional MRI in adults with overweight or obesity. Late-breaking abstract, EASD Annual Meeting 2026.
2. Pratley RE, Adhya R, Casu A, et al. Efficacy of CagriSema on body composition in participants with early type 2 diabetes: REIMAGINE 1. Late-breaking abstract, EASD Annual Meeting 2026. NCT06323174.
3. Haluzík M, Fabricius TW, Gajria R, et al. Effect of CagriSema on bone biomarkers in participants with inadequately controlled type 2 diabetes: REIMAGINE 2. Late-breaking abstract, EASD Annual Meeting 2026. NCT06065540.
4. World Health Organization. Obesity and overweight fact sheet. 8 December 2025.
5. International Diabetes Federation. IDF Diabetes Atlas, 11^th edition.
6. Snel M, Jonker JT, Schoones J, et al. Ectopic fat and insulin resistance: pathophysiology and effect of diet and lifestyle interventions. Int J Endocrinol. 2012;2012:983814.
7. Taylor R. Type 2 diabetes as a disease of ectopic fat? BMC Med. 2014;12:123.

Attachment

• PR260930-EASD-CagriSema

FDA pre-submission feedback supports a Class II strategy, leveraging substantial equivalence to a previously cleared device, positioning the Company for potential initial U.S. clearance of its standalone sensing platform in approximately 15 months

THE WOODLANDS, TX, Sept. 30, 2026 (GLOBE NEWSWIRE) — Autonomix Medical, Inc. (NASDAQ: AMIX) (“Autonomix” or the “Company”), a medical device company dedicated to advancing precision nerve-targeted treatments, today announced the successful completion of a pre-submission meeting with the U.S. Food and Drug Administration (FDA) regarding the Company’s recently announced standalone transvascular sensing platform, which is designed to detect and differentiate faint biological signals.

The FDA interaction provided important guidance regarding Autonomix’s proposed regulatory strategy, validation activities and anticipated submission pathway for the Company’s standalone sensing platform. Based on feedback received, the Company believes it has identified a Class II regulatory pathway that would use an already-cleared reference device to support a substantial-equivalence strategy for its standalone sensing platform.

Subject to successful completion of development and validation activities, and FDA review, Autonomix is targeting potential U.S. clearance in approximately 15 months.

“This FDA interaction gives us greater clarity on the work required to pursue an initial U.S. clearance and represents a significant milestone in advancing our proprietary technology toward the U.S. market,” said Brad Hauser, Chief Executive Officer of Autonomix. “We believe a focused pathway for the standalone sensing platform allows us to pursue a nearer-term regulatory objective, while we continue to build toward the larger opportunity for our technology. Our goal is to establish the sensing foundation first, then expand toward biosignal interpretation and, over time, procedural guidance.”

Autonomix believes successful clearance of the standalone sensing platform could establish a regulatory predicate supporting future generations of its technology platform, including planned signal interpretation and procedular guidance capabilities.

“Our vision is a clear progression: sense, interpret and ultimately guide,” continued Mr. Hauser. “The ability to capture extremely faint biosignals at their source is the critical first step. From there, we believe we can build increasingly powerful computational capabilities, including artificial intelligence, designed to help physicians understand what is happening physiologically, where intervention may be appropriate and what changed following treatment. We believe this staged approach is a disciplined path from standalone sensing toward a broader ‘Sense, Treat and Verify’ platform. We look forward to sharing more in the coming months about how we plan to advance these capabilities.”

The Company will continue development and validation activities associated with its standalone sensing platform while advancing signal interpretation and other advanced computational capabilities for future generations of its platform.

About Autonomix Medical, Inc. 

Autonomix is a medical device company focused on advancing innovative technologies to revolutionize how diseases involving the nervous system are diagnosed and treated. The Company’s first-in-class platform system technology includes a catheter-based microchip sensing array that may have the ability to detect and differentiate neural signals with greater sensitivity than currently available technologies. We believe this will enable, for the first time ever, transvascular diagnosis and treatment of diseases involving the peripheral nervous system virtually anywhere in the body.

Our technology constitutes a platform to address dozens of potential indications, including cardiology, hypertension and chronic pain management, across a wide disease spectrum. Our technology is investigational and has not yet been cleared for marketing in the United States.
 
For more information, visit autonomix.com and connect with the Company on X, LinkedIn, Instagram and Facebook.
 
Forward Looking Statements 

Some of the statements in this release are “forward-looking statements,” which involve risks and uncertainties. Such forward-looking statements can be identified by the use of words such as “should,” “might,” “may,” “intends,” “anticipates,” “believes,” “estimates,” “projects,” “forecasts,” “expects,” “plans,” and “proposes.” Forward-looking statements in this press release include, but are not limited to, expectations regarding the Company’s anticipated regulatory pathway and strategy for its standalone sensing platform, including the potential for Class II clearance based on substantial equivalence, the anticipated timeline for potential U.S. clearance, the potential for a cleared standalone sensing platform to serve as a regulatory predicate for future product generations, the Company’s staged development plans for its platform, including potential signal interpretation and AI-enabled capabilities, the potential effectiveness and clinical benefits of Autonomix’s nerve-targeted treatments for pancreatic cancer pain and other conditions, the versatility and scalability of the Company’s platform technology, the potential for future clinical applications across multiple organ systems, and the strength and scope of the Company’s intellectual property portfolio.

Although Autonomix believes that the expectations reflected in these forward-looking statements are based on reasonable assumptions, there are a number of risks and uncertainties that could cause actual results to differ materially from such forward-looking statements. You are urged to carefully review and consider any cautionary statements and other disclosures, including the statements made under the heading “Risk Factors” and elsewhere in the most recent Annual Report on Form 10-K filed with the U.S. Securities and Exchange Commission (SEC) on May 27, 2026, and from time to time, our other filings with the SEC. Forward-looking statements speak only as of the date of this press release and Autonomix does not undertake any duty to update any forward-looking statements except as may be required by law.

Investor and Media Contact 

JTC Team, LLC 
Jenene Thomas
908.824.0775
autonomix@jtcir.com

The customer transaction arrives with the new $5M facility launch, and additional customer agreements already in the pipeline.

Chicago, IL, Sept. 30, 2026 (GLOBE NEWSWIRE) — Frequency Holdings Inc. (OTC: FRQN), a technology-focused holding company building and acquiring assets across cybersecurity, managed intelligence, digital infrastructure, strategic technology and media, today announced that its wholly owned subsidiary, ReachOut Digital Intelligence, has entered a customer transaction through the new Capchase Pay $5M financing facility announced yesterday. The customer agreement represents nearly $153,000 in contract value.

Customer agreement activates the new $5M financing facility for Frequency Holdings (FRQN)

Frequency announced on September 29 that ReachOut had secured $5 million in funding capacity through Capchase Pay, with eligibility to increase the facility to $10 million after 120 days.

The customer order immediately shows the purpose behind the new $5 million zero-dilution financing facility. Through Capchase Pay, ReachOut can receive payment upfront on multi-year customer agreements while customers pay Capchase over time, allowing contract cash to be brought forward and put back to work in sales, products, and continued growth.

Additional agreements are already progressing through ReachOut’s pipeline.

“We built it. Now we’re already using it,” said Rick Jordan, Founder and CEO of Frequency Holdings. “Yesterday we announced the financial infrastructure. Today we have an agreement moving through it with more to come. That is exactly what this was designed to do. Bring cash forward, put it back to work, and create a growth cycle that can keep repeating.”

From Capacity to Funding with More in the Pipeline

For ReachOut, the structure is particularly relevant to its growing model of multi-year Licensed Protection agreements, which can combine cybersecurity, software, infrastructure, equipment and ongoing technology management.

Instead of collecting the economics of those agreements incrementally over three or five years, ReachOut can accelerate the cash with participating contracts and redeploy that capital into additional growth.

“This is where the model starts to become powerful,” Jordan continued. “Sell. Fund. Deploy. Reinvest. Repeat. The first transaction matters because it takes what we announced yesterday from financial capacity to operating execution.”

Not Corporate Debt to Frequency

The Capchase structure does not represent debt issued by Frequency Holdings. Capchase provides financing to the customer purchasing products and services, while ReachOut receives payment upfront on the entire agreement. The structure gives Frequency a path to accelerate cash without issuing equity or borrowing debt at the FRQN parent-company level.

The distinction is important to Frequency’s broader capital strategy.

Earlier this month, the Company reduced its authorized common shares from 5.4 billion to 250 million and its authorized preferred shares from 1.1 billion to 250 million. Frequency has stated that its objective is to build multiple sources of growth capital rather than assuming every stage of expansion must be funded through additional equity issuance.

The nearly $153,000 transaction was entered through the newly established Capchase relationship. Frequency quickly expects additional ReachOut customer agreements to utilize the structure as the Company continues expanding its cybersecurity, Licensed Protection and managed intelligence offerings.

“We have spent a lot of time talking about structure,” Jordan said. “Now I want the conversation to increasingly be about what we do with it.”

About Frequency Holdings Inc.

Frequency Holdings is a technology-focused holding company building and acquiring assets across cybersecurity, managed intelligence, digital infrastructure, strategic technology, and media. The Company uses recurring customer relationships, proprietary products, acquisitions, and capital infrastructure to create businesses that can scale independently and become more valuable together.
Through ReachOut Digital Intelligence, Frequency provides cybersecurity-first technology, Licensed Protection, managed IT and developing managed intelligence solutions to small and midsize businesses.

Forward-Looking Statements

This press release contains forward-looking statements regarding future customer agreements, use and expansion of the Capchase facility, working capital, growth, managed intelligence commercialization and other future business activities. Forward-looking statements are based on current expectations and assumptions and involve risks and uncertainties that may cause actual results to differ materially.

The Company cannot guarantee the amount or timing of future customer agreements, financing transactions, utilization or expansion of financing capacity, revenue growth or other strategic initiatives discussed herein. Frequency Holdings Inc. undertakes no obligation to publicly update or revise forward-looking statements except as required by applicable law.

Press Inquiries

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pr [at] frequencyhold.com
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https://frequencyhold.com/

• Novel systemic immune data demonstrated T-cell activation following local administration of aglatimagene. Together with recently disclosed evidence of persistent local immune remodeling, these findings provide mechanistic support for the long-term clinical outcomes, including disease-free survival and prolonged time to biochemical failure, time to metastasis, and time to salvage anti-cancer therapy, observed in this patient population
• Biodistribution and shedding data from the PrTK05 phase 2 trial remain on track for inclusion in the planned Q4 2026 Biologics License Application (BLA) submission to the U.S. Food and Drug Administration (FDA) for localized prostate cancer

NEEDHAM, Mass., Sept. 30, 2026 (GLOBE NEWSWIRE) — Candel Therapeutics, Inc. (Candel or the Company) (Nasdaq: CADL), a clinical-stage biopharmaceutical company focused on developing multimodal immunotherapies to improve disease outcomes for patients with cancer, today announced novel immunological biomarker data from the ongoing phase 2 PrTK05 trial (NCT07332000) in patients with intermediate-risk localized prostate cancer. These data, together with histologic and clinical data from the intermediate-risk prostate cancer subgroup of the PrTK03 phase 3 trial (NCT01436968) (635 patients, 85% of the intention-to-treat population), are expected to be presented at a future scientific meeting. Intermediate-risk prostate cancer represents the largest group of patients with localized disease treated with curative-intent external beam radiation therapy (EBRT), accounting for approximately 65,000 patients annually in the United States. Despite radiotherapy, disease recurrence, local and metastatic progression, and the need for salvage anti-cancer therapies that can be associated with substantial toxicity and impaired quality of life remain important unmet needs. This underscores the need for new treatments designed to enhance local tumor control and reduce the risk of disease progression.

PrTK03 Clinical Outcomes

With follow-up through March 15, 2026 (median, 58.0 months), the phase 3 trial showed that patients with intermediate-risk disease (635 patients) treated with aglatimagene plus EBRT experienced a 41% reduction in the risk of prostate cancer recurrence or prostate cancer-specific death versus placebo plus EBRT (HR 0.59; 95% CI 0.41–0.84; p=0.0034).

Additional exploratory, descriptive analyses showed 52% improvement in the time to biochemical failure (HR 0.48; 95% CI 0.22–1.03), a 90% improvement in the time to metastasis (HR=0.10; 95% CI 0.01–0.85), and a 49% reduction in the time to salvage anticancer therapy (HR 0.51; 95% CI 0.24–1.10).

PrTK03 Pathologic and Biomarker Data

Centrally reviewed biopsies from patients with intermediate-risk disease obtained 22–26 months after treatment demonstrated a substantial improvement in rate of negative biopsies, defined as the absence of tumor cells in a standard-of-care diagnostic prostate biopsy. Among 277 evaluable patients with intermediate-risk disease:

• 76.6% (144/188) in the aglatimagene arm had negative biopsies versus 60.7% (54/89) in the control arm
• Positive biopsies were observed in 20.7% of the aglatimagene arm and 38.2% of the control arm (stratified CMH p = 0.0034; chi-square p = 0.0026). Six undetermined biopsies were included in the total number of biopsies analyzed and are part of the denominator.

Building on the AI-enabled histologic analysis presented at ASTRO, exploratory digital pathology analyses showed:

• Increased lymphocytic infiltration after treatment in both arms (p<0.001)
• In paired biopsies with detectable post-treatment tumor (n=98), aglatimagene increased the intratumoral lymphocyte fraction (p=0.002) and lymphocyte–tumor enrichment and mixing scores (both p<0.001)

These immune changes were observed more than two years after treatment.

PrTK05 Systemic Immune Response Data

Early data from the PrTK05 flow-cytometry analyses provided evidence that local treatment with aglatimagene is associated with systemic expansion and activation of multiple circulating cytotoxic T-cell populations. Serial blood samples from 13 patients with intermediate-risk prostate cancer, treated with aglatimagene plus standard-of-care (SoC) EBRT, and 6 patients receiving SoC alone showed expansion of CD8-positive effector and effector-memory T cell populations in the aglatimagene arm, alongside expansion of Ki67-positive proliferating and granzyme B-positive cytotoxic CD8-positive T-cells. These longitudinal findings extend the local PrTK03 tissue observations by suggesting a coordinated systemic immune response beyond the locally treated prostate; formal comparison with SoC-treated controls is ongoing.

Together, these analyses provide complementary evidence of durable local tumor clearance and immune remodeling within the prostate, along with systemic expansion and activation of cytotoxic T-cell populations beyond the treated tumor.

“This signature of coordinated immune activation across tissue and blood in prostate cancer is consistent with findings previously observed following aglatimagene treatment in other solid tumor indications, including NSCLC and high-grade glioma,” said Francesca Barone, M.D., Ph.D., Chief Scientific Officer of Candel Therapeutics. “These findings are consistent with a shared mechanism across solid tumors involving immunogenic tumor cell death followed by individualized local and systemic anti-tumor immunity that does not depend on a predefined antigen or biomarker.”

Paul Peter Tak, M.D., Ph.D., FMedSci, President and Chief Executive Officer of Candel Therapeutics, added, “The evidence of systemic immune activation in intermediate-risk prostate cancer strengthens the biological rationale for evaluating aglatimagene in metastatic solid tumor settings where systemic disease control is critical. These findings underscore the broader potential of our multimodal immunotherapy platform.”

The biodistribution and shedding data from the phase 2 PrTK05 trial have been compiled for inclusion in Candel’s BLA for aglatimagene in localized prostate cancer, which the Company plans to submit to the FDA in Q4 2026. The Company intends to submit the data for presentation at an upcoming scientific conference and for potential publication in a peer-reviewed journal in 2027.        

About aglatimagene besadenovec

Aglatimagene besadenovec (aglatimagene), Candel’s most advanced multimodal biological immunotherapy candidate, is an investigational, off-the-shelf, replication-defective adenovirus designed to deliver the herpes simplex virus thymidine kinase (HSV-tk) gene to a patient’s tumor. After intratumoral administration, HSV-tk enzyme activity results in conversion of prodrug (valacyclovir) into deoxyribonucleic acid (DNA)-incorporating nucleotide analogs, leading to immunogenic cell death in cells exhibiting DNA damage and proliferating cells, with subsequent release of a variety of tumor (neo)antigens in the tumor microenvironment. At the same time, the adenoviral serotype 5 capsid proteins promote inflammation through the induction of expression of pro-inflammatory cytokines, chemokines, and adhesion molecules. Together, this regimen is designed to induce an individualized and specific CD8+ T cell-mediated response against the injected tumor and uninjected distant metastases for broad anti-tumor activity, based on in situ immunization against a variety of tumor antigens. Aglatimagene has the potential to treat a broad range of solid tumors. Encouraging monotherapy activity as well as combination activity with standard of care radiotherapy, surgery, chemotherapy, and immune checkpoint inhibitors have previously been shown in several nonclinical and clinical settings. More than 1,000 patients have been dosed with aglatimagene in clinical trials with a favorable tolerability profile to date, supporting the potential for use with standard of care, when indicated. Aglatimagene is currently not approved by the FDA or any other regulatory authority for any use.

About Candel Therapeutics

Candel is a clinical-stage biopharmaceutical company focused on developing off-the-shelf multimodal biological immunotherapies that elicit an individualized, systemic anti-tumor immune response to help patients fight cancer. Candel has established two clinical-stage multimodal biological immunotherapy platforms based on novel, genetically modified adenovirus and herpes simplex virus (HSV) gene constructs, respectively. Aglatimagene besadenovec (aglatimagene) is the lead product candidate from the adenovirus platform. The Company completed successful phase 2a clinical trials of aglatimagene in non-small cell lung cancer (NSCLC) and pancreatic ductal adenocarcinoma (PDAC), and a pivotal, placebo-controlled, phase 3 clinical trial of aglatimagene in localized prostate cancer, conducted under a Special Protocol Assessment agreed with the FDA and published in The Lancet Oncology. The FDA also granted Fast Track Designation and Regenerative Medicine Advanced Therapy Designation to aglatimagene for the treatment of newly diagnosed localized prostate cancer in patients with intermediate- to high-risk disease, Fast Track Designation in NSCLC, and both Fast Track Designation and Orphan Drug Designation to aglatimagene for the treatment of PDAC.

Linoserpaturev is the lead product candidate from the HSV platform and is currently in an ongoing phase 1b clinical trial in recurrent high-grade glioma, evaluating the effects of repeat linoserpaturev injections. Initial results were published in Nature and Science Translational Medicine and linoserpaturev received Fast Track Designation and Orphan Drug Designation from the FDA. Finally, Candel’s enLIGHTEN™ Discovery Platform is a systematic, iterative HSV-based discovery platform leveraging human biology and advanced analytics to create new viral immunotherapies for solid tumors.

For more information about Candel, visit: www.candeltx.com.

Forward-Looking Statements

This press release includes certain disclosures that contain “forward-looking statements,” within the meaning of the Private Securities Litigation Reform Act of 1995, as amended, including, without limitation, express or implied statements regarding the timing and advancement of current and future development programs, including expectations regarding planned BLA submission and potential commercial readiness; expectations regarding the therapeutic benefit of the Company’s platforms, including the ability of its platforms to improve overall survival and/or disease-free survival of patients living with difficult-to-treat, solid tumors; and expectations regarding the potential benefits conferred by regulatory designations. The words “may,” “will,” “could,” “would,” “should,” “expect,” “plan,” “anticipate,” “intend,” “believe,” “estimate,” “predict,” “project,” “potential,” “continue,” “target” and similar expressions are intended to identify forward-looking statements, although not all forward-looking statements contain these identifying words. Any forward-looking statements in this press release are based on management’s current expectations and beliefs and are subject to a number of risks, uncertainties and important factors that may cause actual events or results to differ materially from those expressed or implied by any forward-looking statements contained in this press release, including, without limitation, those risks and uncertainties related to the timing and advancement of development programs; expectations regarding the therapeutic benefit of the Company’s programs; that final data from the Company’s nonclinical studies and completed clinical trials may differ materially from reported interim data from ongoing studies and trials; the Company’s ability to efficiently discover and develop product candidates; the Company’s ability to obtain and maintain regulatory approval of product candidates; the Company’s ability to maintain its intellectual property; the implementation of the Company’s business model, including strategic plans for the Company’s business and product candidates; the impact of the Company’s existing and any future indebtedness on its ability to operate its business; the Company’s ability to access any future tranches under its debt facility and to comply with all of its obligations thereunder; and other risks identified in the Company’s filings with the U.S. Securities and Exchange Commission (SEC), including the Company’s most recent Annual Report on Form 10-K and any subsequent Quarterly Reports on Form 10-Q, each as filed with the SEC and any subsequent filings with the SEC. The Company cautions you not to place undue reliance on any forward-looking statements, which speak only as of the date they are made. The Company disclaims any obligation to publicly update or revise any such statements to reflect any change in expectations or in events, conditions, or circumstances on which any such statements may be based, or that may affect the likelihood that actual results will differ from those set forth in the forward-looking statements. Any forward-looking statements contained in this press release represent the Company’s views only as of the date hereof and should not be relied upon as representing its views as of any subsequent date.

Investor Contact
Theodore Jenkins
Vice President, Investor Relations, and Business Development
Candel Therapeutics, Inc.
tjenkins@candeltx.com

Media Contact
Ben Shannon
ICR Healthcare
CandelPR@icrhealthcare.com