On October 6, 2026 Ernexa Therapeutics (Nasdaq: ERNA), an industry innovator developing novel cell therapies for the treatment of advanced cancers, reported that new preclinical data from its lead oncology program, ERNA-101, have been selected for a Flash Talk presentation at the Next-Generation Cancer Therapeutics meeting, co-hosted by Nature Conferences and The University of Texas MD Anderson Cancer Center.

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The meeting will take place October 6–8, 2026, on MD Anderson’s campus in Houston, Texas. The presentation will highlight ERNA-101’s potential to address a fundamental challenge in ovarian cancer: the immunosuppressive tumor microenvironment that can limit effective antitumor immune responses. In preclinical models of high-grade serous ovarian cancer, ERNA-101 promoted immune cell recruitment and was associated with significant tumor regression and enhanced survival. When combined with PD-1 checkpoint blockade, ERNA-101 demonstrated enhanced antitumor activity, including complete tumor control and durable responses in the majority of treated animals.

"Selection for presentation at a Nature Conferences meeting co-hosted by MD Anderson Cancer Center highlights the strength of our preclinical findings for ERNA-101, and we look forward to engaging with researchers and oncology leaders focused on advancing the next generation of cancer therapies," said Sanjeev Luther, President and Chief Executive Officer of Ernexa Therapeutics. "Our data demonstrate the potential of our allogeneic, off-the-shelf approach to deliver immune-activating cytokines to the tumor microenvironment, recruit key immune cells and enhance the activity of checkpoint blockade. We believe these findings provide a strong scientific foundation for advancing ERNA-101 toward the clinic and investigating its potential to address the significant unmet need in ovarian cancer."

Presentation Details

Title: IL7-IL15-iMSCs (ERNA-101): Allogeneic, Off-the-Shelf, Next-Generation Immune-Enhancing Cell Therapy of Cancer
Session: Flash Talk Date: Tuesday, October 6, 2026
Location: The University of Texas MD Anderson Cancer Center, Houston, Texas

The presentation will feature preclinical findings demonstrating ERNA-101’s ability to recruit T cells and proinflammatory macrophages and promote an immune-active tumor microenvironment in models of high-grade serous ovarian cancer. In combination with PD-1 checkpoint blockade, ERNA-101 achieved complete tumor control and durable responses in the majority of treated animals, with the findings reproduced in a larger cohort. Biodistribution studies also showed localization of ERNA-101 to the tumor microenvironment, with no detectable signal in the peritoneal wash, serum or other organs evaluated.

Co-hosted by Nature Conferences and MD Anderson Cancer Center, the Next-Generation Cancer Therapeutics meeting will bring together researchers from academia, biotechnology and the pharmaceutical industry to discuss emerging approaches to cancer treatment, including next-generation biologics, immunotherapies, targeted therapies and novel therapeutic platforms. For more information, please visit the conference website.

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

About ERNA-101

ERNA-101 is Ernexa’s lead oncology program, comprising allogeneic, off-the-shelf, induced pluripotent stem cell-derived mesenchymal stromal cells (iMSCs) engineered to express IL-7 and IL-15 as a single fusion protein (IL-7_IL-15-fusokine). ERNA-101 is designed to deliver an immune-activating cytokine payload to the tumor microenvironment, promote antitumor immune responses and potentially enhance the activity of checkpoint blockade. Ernexa is advancing ERNA-101 toward clinical development for ovarian cancer.

(Press release, Ernexa Therapeutics, OCT 6, 2026, View Source [SID1234673244])

On October 6, 2026 Sensible Biotechnologies ("Sensible"), a biotechnology company developing a first-of-its-kind platform for naturally modified mRNA medicines, reported that it has secured $47 million in financing to advance and scale its integrated mRNA technology. The financing includes a Series A and up to $20 million in non-dilutive funding from the Government of Slovakia and the European Union.

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The Series A included participation from new investors OTB Ventures and In-Q-Tel, alongside existing investors Recode Ventures, Isomer Capital, Y Combinator, Backed VC, Kaya VC, Civilization Ventures and BlueYard Capital, as well as the family office of Christoph Huber, Co-Founder of BioNTech, Tim Garnett, former Chief Medical Officer of Eli Lilly, and other individual investors.

The funding will support the development and scale-up of Sensible’s VECTOR (Versatile Engine for Cell-based Therapeutic Optimisation of RNA) platform, expansion of its AI-enabled mRNA design and automated high-throughput screening capabilities, and development of clinical-grade manufacturing capabilities.

"mRNA transformed vaccines, but we believe its greatest potential lies in therapeutics," said Miroslav Gasparek, Chief Executive Officer and Co-Founder of Sensible Biotechnologies. "The field still relies largely on synthetic manufacturing technology developed more than 40 years ago. We are taking a fundamentally different approach, using living cells to produce naturally modified mRNA while reducing the cost and supply-chain constraints of conventional production. With this financing, we can scale our platform and expand mRNA into therapeutic applications requiring high or repeated dosing that have historically been limited by cost."

While mRNA has transformed vaccines, its broader therapeutic potential remains largely unrealized, due in part to the limitations of synthetic production. Sensible is taking a different approach by making mRNA in living cells. Sensible’s VECTOR platform integrates computational and AI-enabled sequence optimization, high-throughput screening and proprietary engineered eukaryotic cells to design and manufacture naturally modified mRNA. The Company’s PromPT technology captures and protects mRNA inside cells before it is purified for therapeutic use.

By harnessing the natural machinery of living cells, Sensible’s platform is designed to produce naturally modified mRNA with reduced immunogenicity and high protein expression while avoiding double-stranded RNA (dsRNA) contamination, a key source of unwanted immune activation. In external evaluations, Sensible’s platform demonstrated the ability to produce cell-made mRNA with no detectable dsRNA contamination, reduced cytokine activation and higher protein expression compared with synthetic mRNA in human immune-cell assays.

Integrating design and manufacturing within a single platform also has the potential to reduce the complexity and supply-chain constraints of conventional mRNA production. By using engineered living cells, Sensible aims to reduce reliance on specialized raw materials and manufacturing inputs, enabling more scalable production and expanding mRNA into therapeutic applications requiring higher or repeated dosing.

In connection with the financing, Dr. Vishal Gulati, FMedSci, Managing Partner at Recode Ventures, and Joel Schoppig, Partner at Oxford Science Enterprises, will join Sensible’s Board of Directors alongside Miroslav Gasparek, Chief Executive Officer and Co-Founder, and Dr. Marian Kupculak, Chief Scientific Officer and Co-Founder.

"The promise of computational drug design depends on connecting it to biology and the practical work of making a medicine. How mRNA is made can shape how it behaves, so manufacturing matters from the very start of developing a treatment. Sensible brings design and cell-based production together, giving the team an opportunity to improve both the performance of mRNA and the economics of making it," said Joel Schoppig, Partner at Oxford Science Enterprises and Board Member at Sensible. "We led this round because we believe in the team’s ability to build a company that helps pharmaceutical partners develop a broader range of mRNA medicines. With this investment, Sensible can advance toward clinical-grade production and expand the pharmaceutical partnerships that will drive its commercial growth."

"The next wave of mRNA medicines reaches far beyond vaccines: in vivo CAR-T, gene editing, and cancer immunotherapy. Yet much of that promise is capped by the limits of today’s mRNA design and manufacturing. Sensible has rebuilt the process from first principles. Its cell-based platform brings design, optimisation and manufacturing into a single loop, producing purer, low-immunogenicity mRNA at industrial scale. That is why we backed Sensible from its earliest round." said Dr Vishal Gulati, FMedSci, Managing Partner at Recode Ventures and Board Member at Sensible.

"Sensible represents exactly that kind of scientific innovation that can help shape the future of medicine," said Kamil Šaško, Minister of Health of the Slovak Republic. "Its work to develop a new generation of mRNA technologies reflects the strength of biotechnology innovation emerging from Slovakia and Europe. We are proud to support Sensible as it advances pioneering science with the potential to enable better medicines, expand the possibilities of mRNA therapeutics, and ultimately improve the lives of patients around the world. Such support is an investment Europe truly needs not only in scientific progress, but in our ability to lead the next generation of biotechnology and healthcare innovation."

The Company has established collaborations to support the validation and scale-up of its technology, such as a strategic partnership with Sartorius to scale its cell-based platform toward clinical-grade mRNA manufacturing and additional partnerships with leading technology companies. Sensible’s cell-based circular RNA manufacturing technology has also been published in Nature Biotechnology and Cell Chemical Biology.

(Press release, Sensible Biotechnologies, OCT 6, 2026, View Source [SID1234673243])

On October 6, 2026 Agendia, Inc., a leader in precision oncology for breast cancer, reported that it will present new research during a podium presentation on the development of an artificial intelligence (AI)-driven digital pathology approach for MammaPrintⓇ at the European Society for Medical Oncology (ESMO) (Free ESMO Whitepaper) Congress 2026, which takes place October 23 to 27, 2026, in Madrid. The company will also present two additional posters at ESMO (Free ESMO Whitepaper).

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AI-driven digital pathology approaches are rapidly developing to expand access to genomic testing globally. Agendia’s first presentation, submitted as a late-breaking abstract, focuses on the development and validation of an AI-driven MammaPrint approach based on the analysis of routine whole slide images of breast cancer tissue.

The following are details of the late-breaking abstract to be presented on the podium:

PODIUM PRESENTATION: AI Driven Digital Pathology for the 70 Gene Recurrence Signature: Development and Validation in Early Stage Breast Cancer

Presenter: Laura van ‘t Veer, PhD, Co-founder and Chief Research Officer, Agendia
Session: AI and digital health
Abstract Number: LBA20
Date / Time: Saturday, October 24, 2026 | 14:45 to 16:15 CEST
Location: Bilbao Auditorium, Hall 3
Agendia will also present two additional posters that draw on the ongoing real-world FLEX Study, demonstrating how a large, real-world breast cancer research platform can support investigations across biomarkers, inherited mutations and genomic tumor biology. The research will highlight the relationship between genomic risk and Ki67 and the correlation between germline BRCA1 and BRCA2 mutations with gene expression profiling.

"Germline BRCA1 and BRCA2 mutations are associated with distinct breast cancer phenotypes, but their association with gene expression-based subtypes has not been well-studied. Ki67 is a biomarker whose utility is limited by variability between laboratories and by the lack of consensus on meaningful levels of expression," said William Audeh, M.D., M.S., Chief Medical Officer at Agendia. "Both studies we are bringing to ESMO (Free ESMO Whitepaper) 2026 to illustrate how genomic risk classification correlates with these biomarkers in a real-world population. The FLEX Study has allowed questions like these to be answerable through the analysis of large scale real-world evidence, and we look forward to sharing the complete findings in Madrid following their scheduled presentations."

The following are details of the two additional abstracts that have been accepted as poster presentations:

70-Gene Signature Provides Prognostic Value Beyond Ki67 in HR+HER2- Early Breast Cancer (EBC)
Presenter: Michael Gnant, MD, Full Professor of Surgery, Medical University of Vienna
Session: Breast cancer, early stage
Presentation Number: 578P
Date / Time: Saturday, October 24, 2026 | 12:00 to 12:45 CEST
Impact of Germline BRCA1 and BRCA2 Mutations on 70-Gene Signature Risk for Patients Enrolled in the FLEX Study
Presenter: Amir Sonnenblick, MD, PhD, Associate Professor, Tel Aviv University
Session: Breast cancer, early stage
Abstract Number: 564P
Date / Time: Saturday, October 24, 2026 | 12:00 to 12:45 CEST
About the FLEX Study
The MammaPrint, BluePrint, and Full-genome Data Linked With Clinical Data to Evaluate New Gene EXpression Profiles (FLEX) Study (NCT03053193) is a large-scale, prospective, observational breast cancer study that links whole transcriptome profiling, including MammaPrint and BluePrint, with complete clinical data. The largest and most diverse early-stage breast cancer cohort, the FLEX Study has enrolled over 25,000 patients globally, including 2,235 self-reported Black/African American, 2,125 Latin American/Hispanic, and 602 Asian American/Pacific Islander patients. FLEX also represents one of the largest cohorts of invasive lobular carcinoma (ILC), with 2,981 ILC and 853 mixed ILC/ductal histology tumors. FLEX supports collaborative substudies designed to expand our understanding of breast cancer biology and inform more personalized, equitable care.

(Press release, Agendia, OCT 6, 2026, View Source [SID1234673242])

On October 6, 2026 Natera, Inc. (NASDAQ: NTRA), a global leader in cell-free DNA and precision medicine, reported new data recently shared at the American Society for Radiation Oncology (ASTRO) 2026 Annual Meeting. The presentations marked Natera’s first participation at ASTRO and a significant step in demonstrating Signatera’s role in treatment response monitoring and risk stratification. All four abstracts were selected for oral presentations, reflecting the breadth of tumor types and treatment settings in which Signatera is demonstrating clinical utility.

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Two presentations from Memorial Sloan Kettering Cancer Center evaluated Signatera for risk stratification in cancers where organ preservation is a treatment goal. In locally advanced rectal cancer (LARC), a real-world study showed that Signatera identified every instance of local cancer growth or recurrence (100% sensitivity), and showed 97% specificity following neoadjuvant treatment. A study in anal squamous cell carcinoma (ASCC) demonstrated that Signatera positivity after definitive chemoradiation therapy (CRT) identified a high-risk group, with 18-month progression-free survival (PFS) of 8% and 18-month overall survival (OS) of 73% after a positive result; among patients who remained Signatera-negative after CRT, 18-month PFS was 97%.

Two presentations in gynecological cancers further support the value of Signatera as a tool for risk stratification and post-treatment monitoring. The first study found that Signatera status by the end of treatment identified patients with significantly improved progression-free survival in patients with vulvovaginal cancer. Signatera positivity also preceded radiographic recurrence in all patients (100% sensitivity) with a median lead time of 117 days. In the second study, in patients with locally advanced cervical cancer treated with chemoradiation, Signatera positivity at the midpoint of treatment identified a patient with subsequent recurrence nine months later, while all patients who were Signatera-negative at the midpoint remained disease free.

"Cancer management is a multidisciplinary effort that includes both local and systemic treatment," said Minetta Liu, M.D., chief medical officer, oncology and early cancer detection, Natera. "Radiation oncologists are on the front lines of some of the most consequential treatment decisions in cancer care, and the data presented at ASTRO support the value of including Signatera monitoring as part of the clinical toolkit. What excites us about these findings is not just the strength of the data, but what they signal about where this field is heading. We are proud to be generating the evidence to help move it there."

Full list of presentations at ASTRO 2026 included:

Abstract #1040
Presenter: Revathi Ravella, M.D.
Tumor-Informed Circulating Tumor DNA for Prediction of Organ Preservation and Enhanced Surveillance in Locally Advanced Rectal Cancer: A Real-World Cohort

Abstract #211
Presenter: Bin Gui, M.D., MS
The Prognostic Role of Circulating Tumor DNA in Vulvovaginal Cancers Undergoing Radiotherapy

Abstract #213
Presenter: Bin Gui, M.D., MS
Circulating Tumor DNA (ctDNA) as an Early Predictive Biomarker of Response in Locally Advanced Cervical Cancer Treated with the Interlace Regimen: A Preliminary Report

Abstract #228
Presenter: Elisa Liu, M.D.
Circulating Tumor DNA Positivity after Chemoradiation Marks an Imminent High-Risk State in Anal Squamous Cell Carcinoma

(Press release, Natera, OCT 6, 2026, View Source [SID1234673241])

On October 6, 2026 KymaThera, a biotechnology company developing next-generation precision medicines for genetically defined diseases, reported the closing of an $80 million Series B financing led by Alta Partners, with participation from Venrock, Foresite Capital, J. Wood Capital and others. Proceeds from the financing will primarily support the advancement of K-1728, KymaThera’s investigational, oral, pan-mutant selective PI3Kα inhibitor. This financing follows the Series A, co-led by Foresite Capital and Venrock in 2024, and brings KymaThera’s total capital raised to more than $100 million.

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KymaThera is initially developing K-1728 as a monotherapy and in combination regimens for HR+/HER2- breast cancer, where substantial unmet need remains despite available therapies, and as a monotherapy for PI3Kα-driven vascular malformations. Vascular malformations are serious, often debilitating conditions for which systemic treatment options remain limited. The company expects to initiate patient dosing in a Phase 1 study in the fourth quarter of 2026, with the financing expected to fund development through initial clinical proof-of-concept.

"I invest in people, and KymaThera has assembled an outstanding team with deep experience in drug discovery and development," said Bob More, Partner at Alta Partners. "Drug development is hard, and great people find ways to solve hard problems. Rob and his team have the experience, scientific rigor and determination to take on an important challenge with K-1728, and I’m thrilled to support them as they advance the company and move the program into the clinic."

"PI3Kα is one of the most important, well-validated, and heavily pursued disease drivers in oncology, but its therapeutic potential has been constrained by wild-type PI3Kα-mediated toxicity and incomplete coverage of clinically relevant mutations," said Rob Kania, Ph.D., Chief Executive Officer of KymaThera. "Our drug design objective from the outset was to address these limitations. K-1728 possesses class-leading potency with helical mutant selectivity windows wider than any reported to date. This financing, backed by an exceptional syndicate of leading life sciences investors, gives us the resources to rapidly advance K-1728 into the clinic and pursue its potential across cancer and vascular malformations."

In preclinical and IND-enabling studies, K-1728 demonstrated potent activity against both kinase and helical domain PI3Kα mutations, driving tumor regressions at low, once-daily doses in models harboring both mutation classes. K-1728 also demonstrated a wide preclinical therapeutic window between exposures associated with deep tumor regressions and those associated with hyperglycemia. These data support a differentiated pan-mutant profile and the advancement of K-1728 into clinical development.

"When we made our Series A investment in KymaThera, we saw an experienced team with a rigorous scientific approach to building differentiated medicines against highly validated targets. K-1728, internally discovered and wholly owned by KymaThera, is an impressive result," said Michael Rome, Ph.D., Managing Director at Foresite Capital. "What the team has accomplished in just two years has strengthened our conviction in both their approach and their ability to execute, and we are excited to continue supporting the company as it enters the clinic," said Mariana Mihalusova, Ph.D., Partner at Venrock.

About K-1728

K-1728 is an investigational, oral, pan-mutant selective PI3Kα inhibitor designed to potently inhibit disease-driving kinase and helical domain mutations while sparing wild-type PI3Kα. KymaThera designed K-1728 using its structure-based drug discovery capabilities to address limitations of earlier generations of PI3Kα inhibitors. Preclinical studies have demonstrated antitumor activity across multiple PI3Kα-mutant models and a differentiated preclinical therapeutic window. KymaThera plans to develop K-1728 across PI3Kα-mutant cancers and vascular malformations.

(Press release, KymaThera, OCT 6, 2026, View Source [SID1234673239])