On September 14, 2026 Radiopharm Theranostics (ASX: RAD, Nasdaq: RADX, "Radiopharm" or the "Company"), a clinical-stage biopharmaceutical company focused on developing innovative oncology radiopharmaceuticals for areas of high unmet medical need, reported that positive data from an interim analysis of the Company’s Phase 2b imaging clinical trial (NCT06777433) of 18F-RAD101 (RAD101) in participants with suspected recurrent brain metastases from solid tumors has been selected for a late-breaking oral presentation at the 31st Annual Meeting of the Society of Neuro-Oncology (SNO26), taking place from November 12-15, 2026 in Philadelphia.

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RAD101 is Radiopharm’s novel imaging small molecule targeting fatty acid synthase (FASN) radiolabelled with Fluorine-18 for the diagnosis of suspected recurrent brain metastases from solid tumors of different origins. The data from these findings will be used to support the initiation of a pivotal multi-center, global Phase 3 imaging trial.

"Having these data selected for a late-breaking oral presentation at SNO26 is a meaningful recognition of the potential clinical importance of RAD101," said Riccardo Canevari, CEO and Managing Director of Radiopharm Theranostics. "The neuro-oncology community understands better than anyone the challenges associated with distinguishing active brain metastases from treatment effects using current imaging approaches. Knowing whether metastatic disease is present can fundamentally alter a patient’s treatment path and prognosis. We believe these data underscore RAD101’s potential to address a significant unmet need by helping physicians make more informed decisions and potentially changing the course of disease management for patients with suspected recurrent brain metastases."

Previously reported results from the Phase 2b imaging trial of RAD101 for all assessed lesions showed 93% concordance between MRI and PET imaging of brain metastases in this patient population with suspected recurrence. The results showed substantial and selective tumor uptake of RAD101. Images confirm metabolic activity in PET compared to equivocal MRI findings. Additionally, 14 patients with evaluable six-month follow-up and/or biopsy data show preliminary 86% sensitivity, representing a strong positive trend (a secondary objective). Sensitivity measures an imaging test’s ability to correctly identify patients with disease.

In the U.S. alone, there are more than 300,000 patients diagnosed annually with cerebral metastases. The incidence of Intracranial Metastatic Disease (IMD) continues to increase, in part, due to improvements in systemic therapy resulting in a more durable control of the tumors outside of the central nervous system. Contrast-enhanced Magnetic Resonance Imaging (CE-MRI) is the preferred method for imaging IMD, but has limitations, particularly in follow-up surveillance scans to optimise patient care.1

RAD101 has received U.S. Food and Drug Administration (FDA) Fast Track Designation to distinguish between recurrent disease and treatment effect of brain metastases originating from solid tumors of different origin including leptomeningeal disease. The company also recently announced a partnership with Siemens Healthineers, who will manufacture and distribute doses of 18F-labeled RAD101 to support Radiopharm’s upcoming Phase 3 pivotal trial in the U.S.

About the Phase 2b Clinical Trial of RAD101

The U.S. multi-center, open-label, single arm Phase 2b clinical trial is assessing the diagnostic
performance of 18F-RAD101 in 30 evaluable individuals with suspected recurrent brain metastases from solid tumors of different origins. The primary objective of the study is concordance between 18F-RAD101 PET-positive lesions and those equivocal lesions seen in conventional imaging (MRI with gadolinium) in participants with known brain metastases and suspected relapse after stereotactic radiosurgery (SRS). Secondary endpoints are sensitivity and specificity of RAD101 in identifying tumor recurrence versus radiation-associated changes in previously SRS-treated brain metastases.

About RAD101

RAD101 is the Company’s novel imaging small molecule that selectively binds to fatty acid synthase (FASN), a multi-enzyme protein that catalyses de-novo fatty acid synthesis and is overexpressed in cerebral metastasis from solid tumors. Targeting FASN activity may allow for the more accurate detection of cancer cells in the CNS, representing a clinically relevant method for the imaging of brain metastases. Positive data from the Imperial College of London’s Phase 2a imaging trial of 18F-RAD101 in patients with brain metastases (both SRS pre-treated and treatment naïve patients) showed significant tumor uptake that was independent from the tumor of origin. The study further indicated that PET-MRI may potentially represent a non-invasive prediction of overall-survival, warranting larger studies.

(Press release, Radiopharm Theranostics, SEP 14, 2026, View Source [SID1234670848])

On September 14, 2026 Telomir Pharmaceuticals, Inc. (NASDAQ:TELO), a clinical-stage biotechnology company developing small-molecule therapeutics targeting epigenetic and metabolic drivers of cancer, reported new research findings from The Ohio State University College of Veterinary Medicine demonstrating that Telomir-Zn produces inhibition of cell growth across human and canine osteosarcoma models. The findings establish a translational foundation for evaluating the compound in a naturally occurring disease setting while the company’s TNBC program simultaneously advances toward site initiation and Phase 1/2 patient enrollment.

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Research Findings
Conducted under the direction of Shay Bracha, DVM, MS, DACVIM (Oncology) at Ohio State’s College of Veterinary Medicine, the study examined Telomir-Zn across three osteosarcoma cell line models: HOS (human), D17 (canine), and Abrams (canine). Researchers evaluated the dose-dependent anti-tumor activity of the compound across all three models.

All three osteosarcoma cell lines demonstrated growth inhibition at similar low drug concentrations. "Osteosarcoma in large-breed dogs remains devastating, with limited treatment options and poor outcomes," noted Bracha, an associate professor at The Ohio State University College of Veterinary Medicine. "These findings suggest Telomir-Zn may offer a meaningful therapeutic opportunity for veterinary patients. The consistency of anti-tumor activity across both canine and human cell lines is particularly compelling because it positions us to explore efficacy in naturally occurring canine osteosarcoma—a model that could accelerate development for both animals and humans."

These results validate the therapeutic potential of Telomir-Zn in osteosarcoma and support further translational investigation.

Osteosarcoma: An Unmet Clinical Need
Osteosarcoma is the most common primary bone malignancy in children and young adults. Despite decades of chemotherapy-based treatment, survival rates for metastatic disease remain below 30%, with minimal improvement over three decades. In veterinary medicine, osteosarcoma is similarly devastating in large-breed dogs, accounting for the majority of primary bone tumors.

The biological similarities between canine and human osteosarcoma, including genetics, tumor biology, and therapeutic response patterns, make the canine model one of the most clinically predictive disease models available for translational research.

Strategic Development Pathway
Based on these findings, Telomir is assessing osteosarcoma development in canine models as a potential therapeutic pathway, which could support both veterinary indication development and translational advancement toward human osteosarcoma:

Track 1: TNBC in Humans — The company’s TNBC program is advancing toward site initiation and Phase 1/2 patient enrollment under an active IND cleared by the FDA, targeting advanced or metastatic triple-negative breast cancer.
Track 2: Osteosarcoma in Dogs — Based on these preclinical findings, Telomir is in conversations with The Ohio State University College of Veterinary Medicine and assessing next steps for a potential in vivo efficacy study in canine osteosarcoma. Such research could accelerate clinical development in canine and human osteosarcoma.
While the company’s immediate focus remains advancing TNBC toward site initiation and Phase 1/2 patient enrollment, these preclinical findings position potential osteosarcoma development in canine models as a strategic opportunity. If pursued, such a dual-pathway approach could expand the therapeutic indication profile while advancing our platform.

The Iron-Modulation Platform
Telomir-Zn targets intracellular iron and copper homeostasis to modulate epigenetic pathways. The mechanism involves disruption of intracellular labile iron pools and inhibition of iron-dependent histone demethylases (KDMs), which reverses cancer-associated epigenetic silencing.

The company’s strategic focus is triple-negative breast cancer, where the TNBC program is advancing toward site initiation and Phase 1/2 patient enrollment. The osteosarcoma preclinical findings provide an additional translational opportunity to validate the mechanism in a naturally occurring disease model (canine) while simultaneously advancing the lead TNBC indication.

(Press release, Telomir Pharmaceutical, SEP 14, 2026, View Source [SID1234670847])

On September 14, 2026 Ernexa Therapeutics (Nasdaq: ERNA), an industry innovator developing novel cell therapies for the treatment of advanced cancers, reported that Sanjeev Luther, President and Chief Executive Officer, will present at the H.C. Wainwright 28th Annual Global Investment Conference, being held September 14–16, 2026, in New York City.

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During the presentation, Mr. Luther will provide an overview of Ernexa’s focused oncology strategy and recent progress with ERNA-101, the Company’s lead oncology cell therapy candidate. The presentation will highlight Ernexa’s differentiated, off-the-shelf-induced mesenchymal stem cell, or iMSC, platform, the growing body of preclinical evidence supporting ERNA-101 and the Company’s planned transition toward clinical development.

Presentation Details for Conference Attendees:

Conference: H.C. Wainwright 28th Annual Global Investment Conference
Presenter: Sanjeev Luther, President & CEO
Date: Wednesday, September 16, 2026
Time: 12:00 p.m. ET
Location: Kennedy I, 4th Floor

In addition to the presentation, Ernexa management will be available for one-on-one meetings with qualified investors during the conference. Investors interested in meeting with Ernexa management are encouraged to contact their H.C. Wainwright representative to request a meeting.

(Press release, Ernexa Therapeutics, SEP 14, 2026, https://www.globenewswire.com/news-release/2026/09/14/3361181/0/en/ernexa-therapeutics-to-present-at-the-h-c-wainwright-28th-annual-global-investment-conference.html [SID1234670846])

On September 14, 2026 PDS Biotechnology Corporation (Nasdaq: PDSB) ("PDS Biotech" or the "Company"), a clinical-stage biotechnology company focused on developing targeted immunotherapies for cancer, reported the initial closing (the "Initial Closing") of the Company’s Private Investment in Public Equity ("PIPE") transaction. The round was led by Nant Capital, LLC ("Nant") with additional participation by current investors. The PIPE also consists of a contingent milestone closing (the "Milestone Closing") as described below.

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At the Initial Closing, the Company sold (i) shares of the Company’s common stock (the "Private Placement Shares") or, at the election of an investor, pre-funded warrants in lieu of such shares ("Pre-Funded Warrants"), and (ii) accompanying common stock purchase warrants ("Common Warrants"). Each unit consisting of one Private Placement Share and a Common Warrant to purchase one-half of one Private Placement Share ("Common Warrants") was issued for $0.2825 (the "Share Unit Purchase Price"), and each unit consisting of one Pre-Funded Warrant to purchase one share of Common Stock and a Common Warrant to purchase one-half of one share of Common Stock was issued for $0.28217 (the "Pre-Funded Unit Purchase Price"). The aggregate gross proceeds and the aggregate number of Private Placement Shares, Pre-Funded Warrants and Common Warrants issued as part of the Initial Closing were approximately $11.3 million, and 16,502,870, 23,498,156 and 20,000,514, respectively.

The Company intends to use the net proceeds from the private placement to repay outstanding indebtedness and for working capital and general corporate purposes, including the continued development of its clinical programs, research and development, and general and administrative expenses. The Company also expects that the PIPE will advance PDS0301 (also referred to as PDS01ADC or NHS-IL12) into late-stage clinical development, based on recent promising interim Phase 2 clinical trial data in microsatellite stable (MSS) and mismatch repair-proficient (pMMR) metastatic colorectal cancer (mCRC), types of colorectal cancer that have not responded well to treatment with immunotherapy. Patients with MSS and pMMR mCRC with liver metastases historically have dire treatment outcomes, with median overall survival of less than 12 months.* In a National Cancer Institute (NCI) led Phase 2 trial, the addition of PDS0301 to standard of care therapy in 22 patients was well tolerated, and demonstrated deep and long-lasting tumor shrinkage and survival, with 80% of patients surviving for at least 24 months.

At the Milestone Closing, which will be triggered by the Company’s submission of a registrational Phase 3 clinical trial protocol for PDS0301 designed in collaboration with Nant to the FDA, Nant and AB Group Ltd. will be obligated to purchase and the Company will be obligated to issue to each of Nant and AB Group Ltd., shares of common stock or Pre-Funded Warrants in lieu thereof for an aggregate purchase price of $10,000,000 and $1,000,000, respectively, subject to the satisfaction or waiver of the applicable closing conditions. The number of securities purchased by any investor will be subject to a 19.9% beneficial ownership limitation.

In addition to the PIPE transaction, and for additional consideration, the Company granted NantWorks, LLC, an affiliate of Nant, a one-year exclusive right to negotiate an exclusive license to PDS0101, the Company’s novel investigational human papilloma virus targeted immunotherapy that stimulates a potent targeted T cell attack against HPV-positive cancers. The option has a term of one year.

Effective as of the Initial Closing, Dr. Soon-Shiong and Mr. James Banaag, who currently serves the as chief financial officer of NantBio, Inc., will join the Company’s board of directors.

Dr. Soon-Shiong commented, "PDS Biotechnology is developing promising novel cancer vaccines and immunocytokines that have demonstrated the potential to harness the power of the immune system to transform cancer care. This is an area of significant interest for me, and I am pleased to join the board of directors and to be able to contribute towards the advancement of these therapies that are aimed at addressing difficult-to-treat cancers."

Dr. Frank Bedu-Addo, founder and CEO of PDS Biotechnology stated, "We believe that the ongoing clinical trials of our IL-12 immunocytokine PDS0301 at the NCI strongly suggest that PDS0301 has the potential to advance the treatment of solid tumors with immunotherapy. We also believe that clinical trials of our cancer vaccine platform demonstrate the potential to advance the field of targeted T cell immunotherapy. We are extremely pleased that Dr. Soon-Shiong and NantWorks share our belief in the promise of our immunotherapy platforms. Dr. Soon-Shiong is a highly accomplished physician scientist, biotechnology entrepreneur and investor who has developed successful cancer therapies including an FDA approved immunocytokine. We are honored to welcome Dr. Soon-Shiong to the company’s board of directors."

Dr. Soon-Shiong, is an internationally recognized physician, surgeon, scientist, and philanthropist who is the author of over 100 peer-reviewed scientific publications and over 500 patents issued worldwide. Dr. Soon-Shiong is the Executive Chairman of ImmunityBio (NASDAQ: IBRX), a company he founded in 2014. He also serves as Chairman of NantHealth (NASDAQ:NH), a transformational healthcare company converging biomolecular medicine and bioinformatics to simplify healthcare. He is also the Chairman and CEO of the Chan Soon-Shiong Institute of Molecular Medicine, a non-profit medical research organization. Dr. Soon-Shiong is also the Owner and Executive Chairman of the Los Angeles Times.

Dr. Soon-Shiong has founded and led global pharmaceutical companies, including American Pharmaceutical Partners, Abraxis BioScience and ImmunityBio. At Abraxis he developed Abraxane, which became the first protein nanoparticle drug for breast, lung, and pancreatic cancers. The drug achieved blockbuster status with annual sales exceeding a billion dollars. Dr. Soon-Shiong’s contribution to the advancement of the oncology field has been honored with the Distinguished Medical Science award by the Smithsonian National Museum of American History where Abraxane is now permanently housed. He has also been honored by the Vatican with the Pontifical Key Visionary Award.

Dr. Soon-Shiong received his medical degree at the University of Witwatersrand, Johannesburg, South Africa and continued his training in surgery at the University of California Los Angeles where he performed the first West Coast pancreas transplant and the world’s first encapsulated islet cell transplant. He is a practicing surgeon and an adjunct Professor of Surgery at UCLA and a visiting Professor at the Imperial College of London.

Born and raised during the apartheid era in South Africa, Dr. Soon-Shiong has lived in Los Angeles since 1980 and is a citizen of the United States.

The securities sold in the PIPE have not been registered under the Securities Act of 1933, as amended (the "Securities Act"), or any state or other applicable jurisdiction’s securities laws and may not be offered or sold in the United States absent registration or an applicable exemption from the registration requirements of the Securities Act and applicable state or other jurisdictions’ securities laws. Concurrently with the execution of the securities purchase agreement, the Company and the investors entered into a registration rights agreement pursuant to which the Company has agreed to file a registration statement with the U.S. Securities and Exchange Commission (the "SEC") registering the resale of the Private Placement Shares and shares of the Company’s common stock underlying the Pre-Funded Warrants and Common Warrants (together, the "Warrant Shares") sold in the PIPE. Any offering of the Private Placement Shares and Warrant Shares under the resale registration statement will only be made by means of a prospectus.

This press release shall not constitute an offer to sell or a solicitation of an offer to buy the Company’s securities, nor shall there be any offer, solicitation, or sale of the Company’s securities in any jurisdiction in which such offer, solicitation or sale would be unlawful.

The private placement was conducted in accordance with applicable Nasdaq rules and was priced to satisfy the "Minimum Price" requirement (as defined in the Nasdaq rules).

(Press release, PDS Biotechnology, SEP 14, 2026, View Source [SID1234670845])

On September 14, 2026 Ataraxis AI, a company building clinical AI tools to personalize cancer care, reported scientific breakthroughs and validation results of Ataraxis’s AI models.

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Ataraxis developed breakthrough causal AI methods that learn from large-scale, longitudinal data to predict patient outcomes in counterfactual treatment scenarios. These methods were encompassed in an AI world model called Ataraxis Tau.
Ataraxis Tau was applied to breast cancer, developing a model simulating patient outcomes with and without adjuvant chemotherapy.
In three clinical validation studies encompassing 18,426 patients, including analyses of Phase 3 randomized controlled trials TAILORx and UNIRAD, Ataraxis’s models were successfully confirmed to be prognostic and predictive of chemotherapy benefit.
Ataraxis Tau generalizes its prognostic and predictive capabilities zero-shot to multiple other solid tumors beyond breast cancer in an analysis of 6,692 patients across 16 other cancer types.
Instead of relying on population-level patient characteristics and biomarkers, Ataraxis developed causal AI methods that simulate individual patient outcomes in counterfactual treatment scenarios. These methods learn to recover treatment effects from routine, longitudinal clinical data as well as from randomized trials. These methods have been incorporated into Ataraxis’s broader AI world model, dubbed Ataraxis Tau.

The first version of Ataraxis Tau was trained primarily with breast cancer data to predict outcomes in patients with hormone receptor-positive, HER2-negative early-stage breast cancer. Specifically, Tau was originally trained to predict outcomes in patients treated with and without chemotherapy. This design allows Ataraxis, for the first time ever, to identify patients who–despite having high baseline risk of recurrence–might not benefit from adjuvant chemotherapy and who might be considered for other adjuvant therapy options.

Ataraxis’s capabilities in breast cancer were confirmed in three clinical validation studies released today: analyses of TAILORx and UNIRAD Phase 3 trials and a real-world multi-institutional study encompassing over 10,000 patients from 17 cohorts in 10 countries.

In the analysis of the TAILORx trial, Ataraxis was found to be predictive of adjuvant chemotherapy benefit (interaction p = 0.016) within the intermediate-risk-score group. Today, these patients are de-escalated to endocrine therapy alone. In Ataraxis’s analysis, the AI model identified patients who benefit from adjuvant chemotherapy with improved 5-year disease-free survival (95.2% vs. 89.6%), while patients predicted to not benefit from chemotherapy had no significant difference in outcomes.
In the analysis of the UNIRAD trial, Ataraxis identified patients within clinically high-risk, node-positive patients who have good long-term outcomes with standard of care therapy. Today, these patients are considered for escalation with drugs such as adjuvant CDK4/6 inhibitors, with no validated biomarkers to help in choices between adjuvant therapy options. Additionally, Ataraxis’s AI model was found to be predictive (p=0.01) of everolimus (mTOR inhibitor) benefit in an identified subgroup.
In a study describing the development and validation of a causal AI model for chemotherapy benefit, Ataraxis included data encompassing 11,135 breast cancer patients from 17 cohorts in 10 countries. The AI model had near-perfect calibration across the full range of predicted risk and was predictive of chemotherapy benefit (p<0.001). Additionally, within a subgroup of 983 patients tested with Oncotype DX, a legacy molecular assay, Ataraxis’s AI model had more robust predictive performance (p=9.7 × 10⁻⁴ versus p=0.025).
Finally, prognostic and predictive capabilities of the Ataraxis Tau world model generalized to cancers it was never trained on. In the real-world study, Ataraxis Tau was applied zero-shot to 6,692 patients spanning 16 cancer types. Ataraxis Tau was prognostic in 11 tumor types, including gastrointestinal cancers, lung cancers, skin cancers, and others. Chemotherapy benefit prediction also transferred zero-shot to five of the seven cancers treated with platinum- or taxane-based regimens, which are shared with breast chemotherapy, showing that Tau learned a treatment-specific predictive signal.

"Today’s results mark a major milestone for Ataraxis. We have previously shown that our AI models can accurately predict outcomes and treatment response in breast cancer. Now, we have gold-standard evidence supporting those findings and the broader clinical use of our tools. These results also bring us closer to a new era of personalized treatment. Our AI world model, Ataraxis Tau, can predict recurrence and treatment benefit across cancer types. As we scale Tau, it will serve as the foundation for future tools designed to help personalize treatment for every cancer patient," said co-founder and CEO of Ataraxis AI, Jan Witowski, MD, PhD.

This distinguishes the result from prior pan-cancer analyses of AI pathology models, which have reported performance only after fitting or fine-tuning a separate model for each cancer type. A causal model trained on breast cancer alone identified risk and chemosensitivity across most other cancers, suggesting it has learned determinants of treatment response that are shared across malignancies rather than specific to one disease.

Ataraxis is building on that foundation, extending individualized benefit prediction to additional therapies and tumor types and working toward a causal model of treatment response that spans oncology, so that any patient facing a treatment decision can be told not just how aggressive their cancer is, but what a given therapy is likely to do for them.

(Press release, Ataraxis AI, SEP 14, 2026, View Source [SID1234670844])