On June 2, 2026 NANOBIOTIX (Euronext: NANO – NASDAQ: NBTX – the "Company"), a late-clinical stage biotechnology company pioneering nanotherapeutic approaches to expand treatment possibilities for patients with cancer and other major diseases, reported an update on operational progress and reported financial results for the first quarter of 2026.

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"Nanobiotix continues to advance with focus, discipline, and ambition as we work to unlock the full potential of physics-based nanotherapeutics," said Laurent Levy, chief executive officer of Nanobiotix and chairman of the executive board. "During the first quarter of 2026, we strengthened our foundation by supporting the advancement of JNJ-1900 (NBTXR3), progressing our Nanoprimer platform, and reinforcing our financial position. We remain deeply grateful to the team members, patients, investigators, collaborators and shareholders who give us their trust, commitment and support as we pursue our mission of revolutionizing treatment outcomes for millions."

Operational Highlights

Part 1 data from Phase 2 JNJ-1900 (NBTXR3) Study in Unresectable Stage 3 NSCLC (CONVERGE) presented at ELCC 2026 and updated at ESTRO 2026
Initial investigator-reported efficacy responses observed in 7 patients following the full treatment regimen of concurrent chemoradiotherapy, JNJ-1900 (NBTXR3), and consolidation with durvalumab showed:
Overall response rate ("ORR") = 85.7% (6/7 patients) reported at ESTRO 2026
In the same cohort of 7 patients, ORR observed at earlier time point and reported at ELCC 2026 was 71.4% (5/7 patients)
Complete response rate ("CRR") = 57.1% (4/7 patients) reported at ESTRO 2026
With the current standard of care, concurrent chemoradiation therapy (cCRT) ± durvalumab, depth of response remains limited in Stage 3 Inoperable NSCLC with very low rates of complete response (<5%)1
Absence of progressive disease and deepening response over time suggests potential for long-term durability
The procedure demonstrated an acceptable safety profile without serious treatment-emergent adverse events (TEAEs)
Early results suggest that intratumoral/intranodal injection of JNJ-1900 (NBTXR3) is feasible and can be performed safely in patients with stage III unresectable NSCLC
Protocol amendment to global Phase 3 JNJ-1900 (NBTXR3) Study in Cisplatin-ineligible Head and Neck Cancer (NANORAY-312)
Interim analysis eliminated and final analysis modified to be conducted sooner with fewer events than originally planned
New preclinical data presented at 2026 AACR (Free AACR Whitepaper) Meeting:
Pre-treatment with Nanoprimer followed by administration of LNP-delivered recombinant DNA ("LNP-DNA") designed for anti-tumor immunotherapy showed increased systemic bioavailability, reduced hepatic toxicity, and reduced cGAS-STING related inflammation compared to LNP-DNA administered without the Nanoprimer

First Quarter Financial Updates

Cash and Cash Equivalents: The Company believes that the net proceeds from the recent follow-on offering, together with its cash and cash equivalents of €42.1 million as of March 31, 2026, will be sufficient to meet its working capital requirements for operations into 2029, consistent with the Company’s currently contemplated cash burn rate.

About JNJ-1900 (NBTXR3)

JNJ-1900 (NBTXR3) is a novel, potentially first-in-class oncology product composed of functionalized hafnium oxide nanoparticles that is administered via one-time intratumoral injection and activated by radiotherapy. Its proof-of-concept was achieved in soft tissue sarcomas through a successful randomized Phase 2/3 study in 2018. 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. Given the physical MoA, Nanobiotix believes that JNJ-1900 (NBTXR3) could be scalable across any solid tumor that can be treated with radiotherapy and across any therapeutic combination, particularly immune checkpoint inhibitors.

Radiotherapy-activated JNJ-1900 (NBTXR3) is being evaluated across multiple solid tumor indications as a single agent or combination therapy. The program is led by NANORAY-312—a global, randomized Phase 3 study in locally advanced head and neck squamous cell cancers. In February 2020, the United States Food and Drug Administration granted regulatory Fast Track designation for the investigation of JNJ-1900 (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—the same population being evaluated in the Phase 3 study.

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 2023, Nanobiotix announced a license agreement for the global co-development and commercialization of JNJ-1900 (NBTXR3) with Janssen Pharmaceutica NV, a Johnson & Johnson company.

(Press release, Nanobiotix, JUN 2, 2026, View Source [SID1234666394])

On June 2, 2026 Can-Fite BioPharma Ltd. (NYSE American: CANF) (TASE: CANF), a clinical-stage biotechnology company developing a pipeline of proprietary small molecule drugs for the treatment of cancer and inflammatory diseases, reported the differentiated mechanism of action of namodenoson in pancreatic cancer, including inhibition of the RAS signaling pathway, alongside encouraging clinical observations from its ongoing Phase 2a pancreatic cancer study.

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Recent presentations and publications emerging from the 2026 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) meeting have reinforced the importance of targeting RAS-driven malignancies, particularly pancreatic ductal adenocarcinoma (PDAC), where KRAS mutations and downstream RAS activation are central drivers of tumor growth and therapeutic resistance. Can-Fite previously reported preclinical findings demonstrating that namodenoson exerts potent anti-tumor activity in pancreatic cancer through a multi-pathway mechanism involving deregulation of the RAS, Wnt/β-catenin, and NF-κB signaling pathways, leading to apoptosis and marked inhibition of tumor growth.

The Company also reported encouraging clinical observations from its Phase 2a study of namodenoson as a monotherapy in pancreatic cancer. Enrollment has been completed and several patients have demonstrated prolonged disease control, including one patient who has remained on therapy and follow-up for approximately 16 months.

"Growing clinical validation of RAS inhibition in pancreatic cancer supports the relevance of the pathway that namodenoson was shown to modulate in our preclinical work," said Pnina Fishman, Chairperson and CSO of Can-Fite BioPharma. "Importantly, namodenoson offers a differentiated approach through simultaneous targeting of RAS, Wnt/β-catenin and NF-κB signaling pathways together with a favorable safety profile observed across clinical programs. The durable observation in our pancreatic study further encourages continued development of namodenoson in this highly aggressive malignancy."

Pancreatic cancer remains among the most lethal malignancies, with limited treatment options and poor long-term survival. Approximately 90% of pancreatic cancers are associated with KRAS pathway activation, highlighting the importance of therapies capable of modulating this signaling network.

About Namodenoson

Namodenoson is a highly selective A3 adenosine receptor (A3AR) agonist, which has shown a compelling safety profile and demonstrated anti-tumor activity in preclinical pancreatic cancer models. The drug is also being evaluated in clinical trials for advanced liver cancer.

Namodenoson has received Orphan Drug Designation from the U.S. Food and Drug Administration (FDA) for the treatment of pancreatic cancer.

(Press release, Can-Fite BioPharma, JUN 2, 2026, View Source [SID1234666363])

On June 2, 2026 Creatv Bio, a Division of Creatv MicroTech, Inc. ("Creatv"), a liquid biopsy company focused on innovative diagnostics for cancer, and Neovia Oncology LLC, a Delaware based pharmaceutical company dedicated to developing novel oncology therapies, reported the signing of a strategic partnership agreement to collaborate on Neovia’s upcoming studies treating patients with advanced multiple drug resistant solid tumors who are entering late lines of therapy.

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The collaboration is expected to generate translational and biomarker data designed to improve patient stratification and deepen understanding of treatment response dynamics in advanced cancers.

In addition to its development as a systemic therapy, Neovia is also evaluating the broader platform potential of NEV-801 in next-generation oncology applications, including antibody-drug conjugate (ADC) strategies.

"We selected Creatv Bio because of their strong scientific capabilities and extensive experience supporting biomarker research across multiple solid tumor types," said Trevor Blake, Founder and CEO of Neovia Oncology. "By integrating advanced liquid biopsy technologies into our clinical development program, we hope to gain deeper insights into patient response patterns and resistance biology as we advance NEV-801."

Creatv’s LifeTracDx blood test isolates Cancer Associated Macrophage-Like Cells (CAMLs) and Circulating Tumor Cells (CTCs) using Creatv’s CellSieveTM microfilters to develop companion diagnostics to monitor drug targets and provide information on patient treatment response.

Dr. Cha-Mei Tang, President and CEO of Creatv Bio added, "Our partnership with Neovia Oncology LLC has the potential to advance the future of cancer diagnosis and treatment, thus saving and improving the lives of cancer patients."

(Press release, Neovia Oncology, JUN 2, 2026, View Source [SID1234666379])

On June 2, 2026 BriaCell Therapeutics Corp. (Nasdaq: BCTX, BCTXL, BCTXZ) (TSX: BCT) ("BriaCell" or the "Company"), a clinical-stage biotechnology company developing novel immunotherapies to transform cancer care, reported the closing of its best-efforts offering of 1,449,300 common shares. Each common share was sold at an offering price of $3.25 per share. All of the common shares in the offering were offered by the Company. Total gross proceeds from the offering, before deducting placement agent’s fees and other offering expenses, were approximately $4.7 million. The Company relied upon the exemption set forth in Section 602.1 of the TSX Company Manual, which provides that the TSX will not apply its standards to certain transactions involving eligible interlisted issuers on a recognized exchange, such as Nasdaq.

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The Company intends to use the net proceeds from the offering for working capital requirements, general corporate purposes, and the advancement of business objectives.

ThinkEquity acted as the sole placement agent for the offering.

The securities described above were offered and sold by the Company pursuant to a shelf registration statement on Form S-3 (File No. 333-276650), including a base prospectus, filed with the U.S. Securities and Exchange Commission (the "SEC") on January 22, 2024 and declared effective on January 31, 2024. The offering was made only by means of a written prospectus. A final prospectus supplement and accompanying prospectus relating to the offering has been filed with the SEC and can be accessed for free on the SEC’s website at www.sec.gov. Copies of the final prospectus supplement and the accompanying prospectus relating to the offering may be obtained, when available, from the offices of ThinkEquity, 17 State Street, 41st Floor, New York, New York 10004.

This press release shall not constitute an offer to sell or a solicitation of an offer to buy, nor shall there be any sale of these securities in any state or jurisdiction in which such an offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of any such state or jurisdiction.

(Press release, BriaCell Therapeutics, JUN 2, 2026, View Source [SID1234666395])

On June 2, 2026 Celcuity Inc. (Nasdaq: CELC), a clinical-stage biotechnology company focused on the development of targeted therapies for the treatment of multiple solid tumor indications, reported detailed efficacy and safety results from the PIK3CA mutant ("MT") cohort of the Phase 3 VIKTORIA-1 clinical trial of gedatolisib, an investigational pan-PI3K/mTORC1/2 inhibitor, in adults with hormone receptor positive ("HR+"), human epidermal growth factor receptor 2 negative ("HER2-"), PIK3CA mutated, locally advanced or metastatic breast cancer ("ABC"), following progression on, or after, treatment with a CDK4/6 inhibitor and an aromatase inhibitor. VIKTORIA-1 is the first Phase 3 clinical trial to compare the efficacy of two PI3K/AKT/mTOR ("PAM") inhibitors in this patient population.

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The study results will be presented in a late-breaking abstract ("LBA") oral session at the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) ("ASCO") Annual Meeting today, Tuesday, June 2, 2026, 12:09 p.m. CDT.

The PAM pathway is a key oncogenic driver of HR+/HER2- breast cancer that requires inhibition of multiple molecular components to comprehensively blockade excessive PAM signaling in tumors with or without a PAM variant. Gedatolisib is the first multitarget PAM inhibitor to demonstrate superior efficacy relative to a single-target inhibitor of this pathway. In the PIK3CA MT cohort of the Phase 3 VIKTORIA-1 trial, the gedatolisib-triplet demonstrated a statistically significant and clinically meaningful improvement in median PFS among patients, increasing the likelihood of survival without disease progression or death by two times compared to alpelisib plus fulvestrant (based on a hazard ratio [HR] of 0.50; 95% CI: 0.37-0.68; p<0.0001). The median PFS, as assessed by blinded independent central review ("BICR"), was nearly two-times longer, 11.1 months versus 5.6 months, compared to alpelisib plus fulvestrant. The ORR of the gedatolisib-triplet was 48.9% compared to 26.0% with alpelisib plus fulvestrant and the median DOR for the gedatolisib triplet was 15.7 months compared to 7.5 months for alpelisib plus fulvestrant.

For the gedatolisib-doublet, the median PFS was more than two-times longer, 11.3 months versus 5.6 months, compared to alpelisib plus fulvestrant (HR=0.51; 95% CI: 0.33-0.79; descriptive p=0.0013). The ORR of the gedatolisib-doublet was 35.7% and the median DOR was 24.2 months.

The topline gedatolisib-triplet efficacy data from the VIKTORIA-1 PIK3CA MT cohort established several new milestones in the history of drug development for HR+/HER2- ABC:

● First Phase 3 trial to demonstrate superiority of one PAM inhibitor versus another.

● The median PFS of 11.1 months for the gedatolisib-triplet is the highest reported by any Phase 3 trial for patients with HR+/HER2- ABC receiving a regimen including endocrine therapy as second-line treatment.

● The objective response rate of 48.9% for the gedatolisib-triplet is the highest reported by any Phase 3 clinical trial for a regimen including endocrine therapy in second-line HR+/HER2- ABC.

"Therapies that target only PI3Kα or AKT typically offer modest benefit for patients with PIK3CA mutant HR+/HER2- advanced breast cancer whose disease has progressed while on or after treatment with a CDK4/6 inhibitor," said Sara Hurvitz, MD, Senior Vice President, Clinical Research Division, Fred Hutchinson Cancer Center, Smith Family Endowed Chair in Women’s Health and Professor and Head, Division of Hematology and Oncology, University of Washington, Department of Medicine and co-principal investigator for the trial. "By comprehensively blocking the PI3K/AKT/mTOR, or PAM, pathway, gedatolisib combined with fulvestrant, with or without palbociclib, showed it can offer these patients two times the likelihood of survival without disease progression or death relative to a single-target inhibitor of the PAM pathway. With these results, the gedatolisib regimens, if approved, represent a new potential standard of care for patients with HR+, HER2-negative, PIK3CA mutant advanced breast cancer whose disease progressed on or after treatment with a CDK4/6 inhibitor."

The gedatolisib-triplet and -doublet were generally well tolerated in the trial with mostly low-grade treatment-related adverse events ("TRAEs"). The most common Grade 3+ TRAEs for the gedatolisib-triplet, the gedatolisib-doublet, and alpelisib plus fulvestrant groups included neutropenia (58.8%, 0%, and 0.7% of patients, respectively); stomatitis (16.3%, 5.8%, and 5.3% of patients, respectively); rash (6.5%, 5.8%, and 15.1% of patients, respectively); and hyperglycemia (2.6%, 0%, and 14.5% of patients, respectively). TRAEs led to the discontinuation of study treatment in 2.6% of patients in the gedatolisib-triplet group, 3.8% in the gedatolisib-doublet group, and 7.1% in the alpelisib plus fulvestrant group. 1One Grade 5 TRAE in the gedatolisib-triplet group, which was related to palbociclib, was reported, no Grade 5 TRAE’s were reported in the gedatolisib-doublet group, and two Grade 5 TRAE’s were reported in the alpelisib plus fulvestrant group.

"Both gedatolisib regimens were well-tolerated with few VIKTORIA-1 patients discontinuing treatment due to an adverse event," said Igor Gorbatchevsky, MD, Chief Medical Officer of Celcuity. "These safety results compare very favorably to those from the patient group treated with alpelisib and fulvestrant, which we believe reflects the benefit of gedatolisib’s multi-target mechanism of action, pharmacokinetic profile, and intravenous administration."

Overall survival, a key secondary endpoint in VIKTORIA-1, while immature at the time of the analysis, showed promising trends for both the gedatolisib-triplet and -doublet.

Celcuity intends to submit these data to the U.S. Food and Drug Administration ("FDA") as a supplemental New Drug Application ("sNDA") and to submit VIKTORIA-1 data to other regulatory authorities following the sNDA submission.

"It is rare in oncology for a targeted therapy to offer both improved efficacy and better safety results relative to another drug in its class," said Brian Sullivan, CEO and co-founder of Celcuity. "This second positive Phase 3 data readout further underscores the broad potential of multi-target PAM inhibition and increases our excitement about our two Phase 3 trials in the first-line setting for HR+/HER2- advanced breast cancer. We are on track to launch gedatolisib commercially, in anticipation of its potential FDA approval in the third quarter of 2026, and we look forward to the possibility of bringing this important therapy to physicians treating patients with advanced breast cancer."

The FDA has granted Priority Review of Celcuity’s New Drug Application ("NDA") for gedatolisib in patients with HR+/HER2-/PIK3CA wild-type ("WT") ABC and assigned a Prescription Drug User Fee Act ("PDUFA") goal date of July 17, 2026.

About HR+/HER2- Breast Cancer

Breast cancer is the second most common cancer and one of the leading causes of cancer-related deaths worldwide.1 More than two million breast cancer cases were diagnosed globally in 2022.1 While survival rates are high for those diagnosed with early breast cancer, only approximately 30% of patients who are diagnosed with or who progress to metastatic disease are expected to live five years after their diagnosis.2 HR+/HER2- breast cancer is the most common subtype of breast cancer, accounting for approximately 70% of all breast cancers.2

Three interconnected signaling pathways, estrogen, cyclin D1-CDK4/6, and the PAM pathway , are primary oncogenic drivers of HR+/HER2- ABC.3 Therapies inhibiting these pathways are approved and used in various combinations for ABC. Currently approved inhibitors of the PAM pathway for breast cancer target a single PAM pathway component, such as PI3Kα, AKT, or mTORC1.4,5,6,7 However, resistance to CDK4/6 inhibitors and current endocrine therapies develops in many patients with advanced disease.8 Optimizing the inhibition of the PAM pathway is an active area of focus for breast cancer research.

About the VIKTORIA-1 Phase 3 Trial

VIKTORIA-1 is a Phase 3 open-label, randomized clinical trial to evaluate the efficacy and safety of gedatolisib in combination with fulvestrant, with or without palbociclib, in adults with HR+/HER2- ABC whose disease progressed on or after prior CDK4/6 therapy in combination with an aromatase inhibitor. The trial enrolled 701 subjects regardless of PIK3CA status while enabling separate evaluation of subjects according to their PIK3CA status. Detailed results from the PIK3CA WT cohort of VIKTORIA-1 have been previously reported. For the PIK3CA MT cohort, 350 subjects who met eligibility criteria and had confirmed PIK3CA mutations were randomly assigned (3:3:1) to receive a regimen of either the gedatolisib-triplet, alpelisib and fulvestrant, or the gedatolisib-doublet.

About Gedatolisib

Gedatolisib is an investigational, multi-target PAM inhibitor that potently targets all four class I PI3K isoforms, mTORC1, and mTORC2 to induce comprehensive blockade of the PAM pathway.9,10,11 As a multi-target PAM inhibitor, gedatolisib’s mechanism of action is highly differentiated from currently approved single-target inhibitors of the PAM pathway.11 Inhibition of only a single PAM component gives tumors an escape mechanism through cross-activation of the uninhibited targets. Gedatolisib’s comprehensive PAM pathway inhibition ensures full suppression of PAM activity by eliminating adaptive resistance cross-activation that occurs with single-target inhibitors. Unlike single-target inhibitors of the PAM pathway, gedatolisib has demonstrated equal potency and comparable cytotoxicity in PIK3CA-mutant and -wild-type breast tumor cells in nonclinical studies and early clinical data.

(Press release, Celcuity, JUN 2, 2026, View Source [SID1234666364])