On September 14, 2026 NANOBIOTIX (Euronext: NANO – NASDAQ: NBTX – the "Company"), a late-stage clinical biotechnology company pioneering physics-based approaches to expand treatment possibilities for patients with cancer and other major diseases, reported updated safety and efficacy data from the completed dose-escalation and expansion phases of a Phase 1 study sponsored by The University of Texas MD Anderson Cancer Center ("UT MD Anderson") evaluating radiotherapy-activated JNJ-1900 (NBTXR3) for patients with inoperable, locoregionally recurrent non-small cell lung cancer ("NSCLC") amenable to re-irradiation ("reRT"). The data were presented by study principal investigator Saumil Gandhi, MD, PhD, at the International Association for the Study of Lung Cancer ("IASLC") 2026 World Conference on Lung Cancer ("WCLC"), taking place September 12–15, 2026 in Seoul, Republic of Korea.

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POSTER P2.260: Re-irradiation (ReRT) with NBTXR3 for Inoperable Locoregionally Recurrent Non-Small Cell Lung Cancer (NSCLC): A Phase I Trial

Saumil N. Gandhi, MD, PhD; Enoch Chang, MD; Aileen B. Chen, MD; Stephen G. Chun, MD; Joe Y. Chang, MD, PhD; Steven H. Lin, MD, PhD; Matthew S. Ning, MD, MPH; David Qian, MD; Julianna K. Bronk, MD, PhD; Rahul A. Sheth, MD; Jianjun Zhang, MD, PhD; Tina Cascone, MD, PhD; Marcelo Vailati Negrao, MD; Anne S. Tsao, MD; George R. Blumenschein, MD; Mehmet Altan, MD; John V. Heymach, MD, PhD; James W. Welsh, MD; Suyu Liu, PhD; Zhongxing Liao, MD; Roberto F. Casal, MD — The University of Texas MD Anderson Cancer Center

Patients who are candidates for re-irradiation are frequently limited to palliative radiation doses because of normal-tissue tolerance, and their recurrent tumors typically harbor the most radiation-resistant cells. Effective strategies to safely deliver radiotherapy doses capable of controlling recurrent tumors remain a significant unmet need in this setting.

"Recurrence within a previously irradiated field is one of the least forgiving problems in thoracic oncology," said Saumil Gandhi, MD, PhD, Department of Thoracic Radiation Oncology, Division of Radiation Oncology at UT MD Anderson. "The normal tissue near the tumor has already received a full course of radiation, so the dose that can delivered safely during a second course is limited. Additionally, the disease that returns is often more radioresistant because it survived radiation the first time. In this study, JNJ-1900 (NBTXR3) was delivered without dose-limiting toxicities, and we observed clinically meaningful local control at a substantially lower re-irradiation dose. These findings warrant evaluation in a randomized trial."

Results from the pooled dose-escalation and expansion phases showed that all 24 patients completed treatment with JNJ-1900 (NBTXR3) plus re-irradiation with no dose-limiting toxicities. Investigators reported no Grade 3 or higher adverse events related to JNJ-1900 (NBTXR3) or to the injection procedure.

Grade 3 radiotherapy-related adverse events occurred in 33% of patients (n=8), and Grade 5 radiotherapy-related adverse events in 8% (n=2). The recommended Phase 2 dose was established at 33% of gross tumor volume.

At a median follow-up of 12 months (data cutoff: August 2026) the one-year locoregional control rate was 79%. One-year local progression-free survival ("LPFS") was 61% (median 13.6 months), and one-year overall survival ("OS") was 70% (median 14.8 months). Investigators concluded that JNJ-1900 (NBTXR3) may permit clinically meaningful local control using a substantially lower re-irradiation dose.

"The Nanobiotix team is encouraged by these full-cohort findings in one of the most difficult settings in lung cancer," said Louis Kayitalire, MD, Chief Medical Officer of Nanobiotix. "If a physics-based approach can improve local control in tissue that has already failed radiation, and do so at a reduced dose, then the conditions in earlier settings, where full-dose radiotherapy reaches previously untreated tissue, could be even more favorable. We look forward to further evaluation in additional patients enrolled to this study and across indications."

Enrollment in both the dose-escalation and expansion parts of the study is complete per protocol. Following the encouraging findings, additional patient enrollment in this study is planned.

About JNJ-1900 (NBTXR3)

JNJ-1900 (NBTXR3) is a novel, potentially first-in-class oncology product composed of functionalized hafnium oxide nanoparticles administered via one-time intratumoral injection and activated by radiotherapy. The product candidate’s mechanism of action (MoA) is designed to induce significant tumor cell death in the injected tumor when activated by radiotherapy, subsequently triggering adaptive immune response and long-term anti-cancer memory. Proof-of-concept was demonstrated in a randomized Phase 2/3 soft tissue sarcoma study sponsored by Nanobiotix in 2018.

Radiotherapy-activated JNJ-1900 (NBTXR3) is being evaluated across multiple solid tumor indications as a single agent or combination therapy. Given the Company’s focus areas, and balanced against the scalable potential of NBTXR3, Nanobiotix has engaged in a collaboration strategy to expand development of the product candidate in parallel with its priority development pathways. Pursuant to this strategy, in 2019 Nanobiotix entered into a broad, comprehensive clinical research collaboration with The University of Texas MD Anderson Cancer Center to sponsor several Phase 1 and Phase 2 studies evaluating JNJ-1900 (NBTXR3) across tumor types and therapeutic combinations.

In February 2020, the United States Food and Drug Administration granted regulatory Fast Track designation for the investigation of NBTXR3 activated by radiation therapy, with or without cetuximab, for the treatment of patients with locally advanced HNSCC who are not eligible for platinum-based chemotherapy.

In 2023, Nanobiotix announced a license agreement for the global development and commercialization of JNJ-1900 (NBTXR3) with Janssen Pharmaceutica NV, a Johnson & Johnson company. Studies being led by Johnson & Johnson include NANORAY-312 (NCT04892173), a global, randomized Phase 3 study in platinum-based chemotherapy-ineligible, locally advanced head and neck squamous cell cancers; LUMIRAY (NCT07219212), a global, phase 1b, open-label study in locally advanced head and neck squamous cell cancers; and CONVERGE (NCT06667908), a phase 2, randomized, open-label, active-controlled study in locally advanced and unresectable Stage III non-small cell lung cancer (NSCLC).

(Press release, Nanobiotix, SEP 14, 2026, View Source [SID1234670821])

On September 14, 2026 Moleculin Biotech, Inc. (Nasdaq: MBRX) ("Moleculin" or the "Company") reported that new data on its lead drug candidate, Annamycin (naxtarubicin), will be presented at three scientific venues in September 2026, including the American Association for Cancer Research (AACR) (Free AACR Whitepaper) Conference on Pancreatic Cancer: New Frontiers in Biology and Therapeutic Development.

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The three presentations address distinct questions about Annamycin: where it concentrates in the body, how it kills cancer cells, and whether it can also enlist the immune system to do so. Together they inform the Company’s development of Annamycin in hard-to-treat cancers.

Title: "Antitumor activity of ANNAMYCIN, a highly effective lipophilic DNA-binding drug: Impact of its organotropism"
Author/Presenter: Waldemar Priebe, PhD, UT MD Anderson Cancer Center
Congress: XIII Congress of the Polish Medical Diaspora
Dates: September 9-12, 2026
Location: Wroclaw, Poland

Annamycin’s lipophilic structure drives it to concentrate in specific tissues rather than distribute uniformly. Dr. Priebe’s presentation examines how that distribution relates to the antitumor activity observed across preclinical models, and what it may mean for treating tumors in those tissues.

Title: "Organotropism-guided exploration of anticancer properties of Annamycin (naxtarubicin), a potent topoisomerase II targeting agent"
Author/Presenter: Waldemar Priebe, PhD, UT MD Anderson Cancer Center
Event: Invited Lecture at the Hirszfeld Institute of Immunology and Experimental Therapy, Polish Academy of Sciences
Date: September 14, 2026
Location: Wroclaw, Poland

This invited lecture extends the same line of inquiry to mechanism, examining how Annamycin’s tissue distribution interacts with its inhibition of topoisomerase II, the enzyme target through which anthracyclines produce DNA damage in dividing cells.

Title: "Turning cold pancreatic tumors hot: Antitumor activity of Annamycin is partially mediated by CD8+ T cell cytotoxicity"
Author/Presenter: Angela T. Alistar, MD, Morristown Medical Center, Atlantic Health System / Carol G. Simon Cancer Center
Congress: AACR (Free AACR Whitepaper) Conference on Pancreatic Cancer: New Frontiers in Biology and Therapeutic Development
Dates: September 25-28, 2026
Location: Hilton San Diego Bayfront, San Diego, California

The abstract for this presentation remains under embargo until publication. Moleculin expects to report on the findings when the abstract is published, as described below.

Abstracts selected for presentation at the AACR (Free AACR Whitepaper) Conference on Pancreatic Cancer will be published as a supplement to the September 15, 2026 issue of Cancer Research on September 25, 2026, at 1:00 p.m. ET.

"Annamycin’s ability to concentrate in specific tissues is one of the properties that most distinguishes it from currently prescribed anthracyclines, and it is the through-line across these presentations," said Walter Klemp, Chairman, President and Chief Executive Officer of Moleculin. "Having this work presented by leading investigators, and accepted at an AACR (Free AACR Whitepaper) conference, reflects the breadth of scientific interest in Annamycin beyond our lead indication in AML."

These presentations run alongside Moleculin’s lead clinical program, the ongoing MIRACLE trial evaluating AnnAraC in patients with relapsed or refractory acute myeloid leukemia (AML). MIRACLE remains the Company’s primary development focus and the basis of its near-term milestones.

(Press release, Moleculin, SEP 14, 2026, View Source [SID1234670820])

On September 14, 2026 Kairos Pharma presented its corporate presentation.

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(Presentation, Kairos Pharma, SEP 14, 2026, View Source [SID1234670819])

On September 14, 2026 Immunocore Holdings plc (Nasdaq: IMCR) ("Immunocore" or the "Company"), a commercial-stage biotechnology company pioneering and delivering transformative immunomodulating medicines to radically improve outcomes for patients with cancer, infectious diseases and autoimmune diseases, reported the achievement of target patient enrollment (540 patients) in the TEBE-AM clinical trial (NCT05549297).

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TEBE-AM is a global, randomized, registrational Phase 3 clinical trial evaluating KIMMTRAK (tebentafusp) as monotherapy and in combination with pembrolizumab, versus Investigator’s Choice, for the treatment of HLA-A*02:01-positive patients with advanced melanoma whose disease has progressed following prior therapy. The primary endpoint is overall survival.

"Achieving target enrollment in TEBE-AM is an important milestone for Immunocore and a critical step toward addressing the substantial unmet need in previously treated, post-PD1 advanced melanoma, a setting with limited treatment options," said Mohammed Dar, Chief Medical Officer of Immunocore. "We are grateful to the patients and investigators participating in the trial."

With target enrollment now achieved, patients enrolled in the trial will continue to be followed for the planned overall survival analysis.

The Company believes tebentafusp has the potential to address a significant unmet need for up to 4,000 HLA-A*02:01-positive patients with previously treated advanced melanoma in the post-PD1 setting, in the United States and Europe. The Company expects to be able to share topline data as early as the end of 2026.

(Press release, Immunocore, SEP 14, 2026, View Source [SID1234670818])

On September 14, 2026 Curium reported that the U.S. Food and Drug Administration (FDA) has approved its New Drug Application (NDA) for BEXLUTRY lutetium Lu 177 dotatate injection for the treatment of somatostatin receptor-positive gastroenteropancreatic neuroendocrine tumors (GEP-NETs), including foregut, midgut, and hindgut neuroendocrine tumors in adults.

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BEXLUTRY is a radioligand therapy designed to deliver targeted radiation to GEP-NETs by binding to somatostatin receptors commonly expressed on these tumors. NETs originate from neuroendocrine cells, which are specialized cells widely dispersed throughout the body’s organs. The site of origin can vary because of the broad distribution of neuroendocrine cells. GEP-NETs represent 60-70% of NETs.

BEXLUTRY is a radioligand equivalent approved through the FDA’s 505(b)(2) pathway targeting LUTATHERA (lutetium Lu 177 dotatate), supported by published evidence and targeted bridging data that demonstrated a similar biological and chemical profile to a previously approved radiopharmaceutical therapy.

Renaud Dehareng, Curium’s Group Chief Executive Offer, said: "FDA approval of BEXLUTRY is a defining milestone for Curium as we expand our offering into oncology therapeutics. With over 100 years of experience in nuclear medicine and a long-standing commitment to the NET community, we are now bringing the full diagnosis-to-therapy capability needed to scale theranostics responsibly. For decades, Curium has earned trust in nuclear medicine through reliability, quality and day-in, day-out delivery. We are applying that same discipline and commitment to help eligible NET patients access radioligand therapy with confidence."

Mike Patterson, Curium’s North American Chief Executive Officer, said: "As the only vertically integrated, lutetium-based NETs therapy manufacturer, Curium is uniquely positioned to support a reliable supply of BEXLUTRY and help sites of care prepare for radioligand therapy delivery at scale. Today’s FDA approval brings us a step closer to advancing our ambition of aiming to improve the lives of up to 80% of patients with cancer. Our priority now is a high-quality launch supported by our end-to-end nuclear medicine infrastructure, designed to help ensure consistent delivery, predictable scheduling support for sites of care, and a dependable experience for patients receiving radioligand therapy."

BEXLUTRY is now available for prescribing physicians and patient use. Visit www.bexlutry.com.

About BEXLUTRY

INDICATIONS AND USAGE

BexlutryTM (lutetium Lu 177 dotatate injection) is indicated for the treatment of adults with somatostatin receptor-positive gastroenteropancreatic neuroendocrine tumors (GEP-NETs), including foregut, midgut, and hindgut neuroendocrine tumors.

IMPORTANT SAFETY INFORMATION

WARNINGS AND PRECAUTIONS

Risk From Radiation Exposure: Bexlutry contributes to a patient’s overall long-term cumulative radiation exposure. Long-term cumulative radiation exposure is associated with an increased risk for cancer. These risks of radiation associated with the use of Bexlutry are greater in pediatric patients than in adults.
Radiation can be detected in the urine for up to 30 days following Bexlutry administration. Minimize radiation exposure to patients, medical personnel, and household contacts during and after treatment with Bexlutry consistent with institutional good radiation safety practices, patient management procedures, Nuclear Regulatory Commission patient-release guidance, and instructions to the patient for follow-up radiation protection at home.
Myelosuppression: In NETTER-1, myelosuppression occurred more frequently in patients receiving lutetium Lu 177 dotatate injection with long-acting octreotide compared to patients receiving high-dose long-acting octreotide (all Grades/Grade 3 or 4): anemia (81%/0) versus (54%/1%); thrombocytopenia (53%/1%) versus (17%/0); and neutropenia (26%/3%) versus (11%/0). In NETTER-1, platelet nadir occurred at a median of 5.1 months following the first dose. Of the 59 patients who developed thrombocytopenia, 68% had platelet recovery to baseline or normal levels. The median time to platelet recovery was 2 months. Fifteen of the nineteen patients in whom platelet recovery was not documented had post-nadir platelet counts. Among these 15 patients, 5 improved to Grade 1, 9 to Grade 2, and 1 to Grade 3. Monitor blood cell counts. Withhold dose, reduce dose, or permanently discontinue Bexlutry based on the severity of myelosuppression.
Secondary Myelodysplastic Syndrome (MDS) and Leukemia: In NETTER-1, with a median follow-up time of 76 months in the main study, myelodysplastic syndrome (MDS) was reported in 2.3% of patients receiving lutetium Lu 177 dotatate injection with long-acting octreotide compared to no patients receiving high-dose long-acting octreotide.
In ERASMUS, 16 patients (2.0%) developed MDS and 4 (0.5%) developed acute leukemia. The median time to onset was 29 months (9 to 45 months) for MDS and 55 months (32 to 125 months) for acute leukemia.
Renal Toxicity: In ERASMUS, 8 patients (< 1%) developed renal failure 3 to 36 months following lutetium Lu 177 dotatate injection. Two of these patients had underlying renal impairment or risk factors for renal failure (e.g., diabetes or hypertension) and required dialysis.
Administer the recommended amino acid solution before, during and after Bexlutry to decrease the reabsorption of lutetium Lu 177 dotatate through the proximal tubules and decrease the radiation dose to the kidneys. Advise patients to hydrate and to urinate frequently before, on the day of, and the day after administration of Bexlutry.

Monitor serum creatinine and calculated creatinine clearance. Withhold dose, reduce dose, or permanently discontinue Bexlutry based on the severity of renal toxicity.

Patients with baseline renal impairment may be at increased risk of toxicity due to increased radiation exposure.

Hepatotoxicity: In ERASMUS, 2 patients (< 1%) were reported to have hepatic tumor hemorrhage, edema, or necrosis, with one patient experiencing intrahepatic congestion and cholestasis. Patients with hepatic metastasis may be at increased risk of hepatotoxicity due to radiation exposure.
Monitor transaminases, bilirubin, serum albumin, and international normalized ratio (INR) during treatment. Withhold dose, reduce dose, or permanently discontinue Bexlutry based on the severity of hepatotoxicity.

Hypersensitivity Reactions: Hypersensitivity reactions, including angioedema, occurred in patients treated with lutetium Lu 177 dotatate injection. Monitor patients closely for signs and symptoms of hypersensitivity reactions, including anaphylaxis, during and following Bexlutry administration for a minimum of 2 hours in a setting where cardiopulmonary resuscitation medication and equipment are available. Discontinue the infusion upon the first observation of any signs or symptoms consistent with a severe hypersensitivity reaction and initiate appropriate therapy.
Premedicate patients with a history of Grade 1 or 2 hypersensitivity reactions to Bexlutry before subsequent doses. Permanently discontinue Bexlutry in patients who experience Grade 3 or 4 hypersensitivity reactions.

Neuroendocrine Hormonal Crisis: Neuroendocrine hormonal crises, manifesting with flushing, diarrhea, bronchospasm and hypotension, occurred in < 1% of patients in ERASMUS and typically occurred during or within 24 hours following the initial lutetium Lu 177 dotatate injection dose. Two (< 1%) patients were reported to have hypercalcemia. Monitor patients for flushing, diarrhea, hypotension, bronchoconstriction or other signs and symptoms of tumor-related hormonal release. Administer intravenous somatostatin analogs, fluids, corticosteroids, and electrolytes as indicated.
Embryo-Fetal Toxicity: Based on its mechanism of action, Bexlutry can cause fetal harm when administered to a pregnant woman. Verify pregnancy status of females of reproductive potential prior to initiating Bexlutry. Advise pregnant women of the potential risk to a fetus. Advise females of reproductive potential to use effective contraception during treatment with Bexlutry and for 7 months after the last dose. Advise males with female partners of reproductive potential to use effective contraception during treatment with Bexlutry and for 4 months after the last dose.
Risk of Infertility: Bexlutry may cause infertility in males and females. The recommended cumulative dose of 29.6 GBq of Bexlutry results in a radiation absorbed dose to the testes and ovaries within the range where temporary or permanent infertility can be expected following external beam radiotherapy.

ADVERSE REACTIONS

The most common Grade 3-4 adverse reactions (≥ 4% with a higher incidence in lutetium Lu 177 dotatate injection arm) reported in NETTER-1 were lymphopenia, increased GGT, vomiting, nausea, increased AST, increased ALT, hyperglycemia and hypokalemia.

With a median follow-up time of more than 4 years, the following rates of serious adverse reactions were reported in ERASMUS: myelodysplastic syndrome (2%), acute leukemia (1%), renal failure (2%), hypotension (1%), cardiac failure (2%), myocardial infarction (1%), and neuroendocrine hormonal crisis (1%).

DRUG INTERACTIONS

Somatostatin Analogs: Somatostatin and its analogs competitively bind to somatostatin receptors and may interfere with the efficacy of Bexlutry. Discontinue long-acting somatostatin analogs at least 4 weeks and short-acting octreotide at least 24 hours prior to each Bexlutry dose. Administer short- and long-acting octreotide during Bexlutry treatment as recommended.

Glucocorticoids: Glucocorticoids can induce down-regulation of subtype 2 somatostatin receptors (SSTR2). Avoid repeated administration of high doses of glucocorticoids during treatment with Bexlutry.

USE IN SPECIFIC POPULATIONS

Lactation

Advise women not to breastfeed during treatment with Bexlutry and for 2.5 months after the last dose.

Pediatric Use

Somatostatin Receptor-Positive Gastroenteropancreatic Neuroendocrine Tumors: The risks of radiation exposure associated with Bexlutry are greater in pediatric patients than in adult patients due to longer life expectancy. The safety and effectiveness of Bexlutry have not been established in pediatric patients younger than 12 years old with somatostatin receptor-positive GEP-NETs.

Pediatric use information is approved for Advanced Accelerator Applications USA INC’s LUTATHERA (lutetium Lu 177 dotatate) injection for intravenous use. However, due to Advanced Accelerator Applications USA Inc.’s marketing exclusivity rights, this drug product is not labeled with that pediatric information.

*LUTATHERA is a registered trademark of Advanced Accelerator Applications International SA.

(Press release, Curium Pharma, SEP 14, 2026, View Source [SID1234670816])