NANOBIOTIX Announces Closing of Global Offering

On May 26, 2026 NANOBIOTIX (Euronext: NANO – NASDAQ: NBTX – "Nanobiotix" or the "Company"), a late-clinical stage biotechnology company pioneering physics-based approaches to expand treatment possibilities for patients with cancer and other major diseases, reported the closing today (the "Closing") of its global offering (the "Global Offering"), including in respect of the earlier total exercise by the underwriters of their option (the "Option") to purchase additional new ordinary shares in the form of additional American Depositary Shares (the "Additional ADSs").

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Following the full exercise of the Option, the total number of ordinary shares (each an "Ordinary Share"), of the Company and pre-funded warrants to subscribe for one Ordinary Share each (the "PFW") issued in the Global Offering amounts to 2,218,467 Ordinary Shares, including 225,373 Ordinary Shares in the form of American Depositary Shares ("ADSs") and 33,805 Ordinary Shares in the form of Additional ADSs, and 345,099 PFW, resulting in aggregate gross proceeds for the Company of approximately $100 million (corresponding to approximately €86.1 million), before deducting underwriting commissions in respect of the Global Offering and estimated expenses related to the Global Offering.

The subscription price of €33.60 per Ordinary Share, corresponding to the offering price of $38.98 per ADS based on an exchange rate of €1.00 = $1.16 as published by the European Central Bank on May 20, 2026, is equal to the volume weighted average price of the Ordinary Shares on the regulated market of Euronext in Paris over the last three trading sessions preceding the pricing of the Global Offering (i.e. May 18, May 19 and May 20, 2026), less a discount of 14.92% and has been determined by the Company pursuant to the 29th resolution of the Company’s combined shareholders’ meeting held on May 19, 2025. The subscription price of each PFW is equal to the subscription price per Ordinary Share issued in the Global Offering minus their nominal value of €0.03 per Ordinary Share.

The Company intends to use the net proceeds from the Global Offering, including the net proceeds from the sale of the Additional ADSs, as follows:

less than 10% to support the development and advancement of JNJ-1900 (NBTXR3);
between 50-60% to advance our Nanoprimer and other platforms; and
between 30-40% for general corporate purposes.

The expected use of proceeds represents the Company’s intentions based upon its current plans and business conditions. The Company cannot predict with certainty all of the particular uses for the net proceeds to be received upon the completion of Global Offering (including the Additional ADSs) or the amounts that the Company will actually spend on the uses set forth above. The amounts and timing of the Company’s actual expenditures and the extent of clinical development may vary significantly depending on numerous factors, including the progress of the development efforts, the status of and results from preclinical studies and any ongoing clinical trials or clinical trials the Company may commence in the future, as well as any collaborations that the Company may enter into with third parties for its product candidates and any unforeseen cash needs. As a result, the Company’s management will retain broad discretion over the allocation of the net proceeds.

The Company believes that the net proceeds from the Global Offering (including the Additional ADSs), together with its cash and cash equivalents, will be sufficient to meet its working capital requirements for operations into 2029, consistent with the Company’s currently contemplated cash burn rate.

Jefferies, TD Cowen and Stifel acted as global coordinators and joint bookrunners for the Global Offering.

Jefferies LLC, acting as the stabilizing agent on its own behalf and on behalf of the other Underwriters, reported that no stabilization activities had been carried out and the stabilization period is now closed.

The ADSs are listed on the Nasdaq Global Select Market under the symbol "NBTX" and the Company’s Ordinary Shares are listed on Euronext Paris under the symbol "NANO".

The ADSs (including the Additional ADSs) and Ordinary Shares issued in the Global Offering were offered pursuant to an effective shelf registration statement on Form F-3 (Registration No. 333-285604), which was filed with the Securities and Exchange Commission (the "SEC") on March 6, 2025 and subsequently declared effective on March 14, 2025. The Global Offering was made only by means of a prospectus and prospectus supplement that form a part of the registration statement. A final prospectus supplement relating to and describing the terms of the Global Offering has been filed with the SEC on May 22, 2026 and is available on the SEC’s website at www.sec.gov. The final prospectus supplement relating to the Global Offering (and accompanying prospectus) relating to the Global Offering may be obtained from Jefferies LLC, Attention: Equity Syndicate Prospectus Department, 520 Madison Avenue, New York, NY 10022, or by telephone at (877) 821-7388 or by email at [email protected]; from Stifel, Nicolaus & Company, Incorporated, Attention: Syndicate, One Montgomery Street, Suite 3700, San Francisco, CA 94104, by telephone at (415) 364-2720 or by email at [email protected]; or from TD Securities (USA) LLC, c/o Broadridge Financial Solutions, 1155 Long Island Avenue, Edgewood, NY 11717, or by email at [email protected].

(Press release, Nanobiotix, MAY 26, 2026, View Source [SID1234666080])

Datroway approved in the US as first TROP2-directed antibody drug conjugate for 1st-line treatment of patients with metastatic triple-negative breast cancer who are not PD-1/PD-L1 inhibitor candidates

On May 26, 2026 AstraZeneca and Daiichi Sankyo reported Datroway (datopotamab deruxtecan) has been approved in the US for the treatment of adult patients with unresectable or metastatic triple-negative breast cancer (TNBC) who are not candidates for PD-1/PD-L1 inhibitor therapy.

The approval follows Priority Review by the Food and Drug Administration (FDA) based on results from the TROPION-Breast02 Phase III trial which were presented at the 2025 European Society for Medical Oncology Congress and published in Annals of Oncology.

Tiffany A. Traina, MD, FASCO, Section Head, Triple-Negative Breast Cancer Clinical Research Programme, Memorial Sloan Kettering Cancer Centre and investigator for TROPION-Breast02, said: "Datopotamab deruxtecan is the first and only medicine to significantly prolong overall survival in the 1st-line setting compared to chemotherapy in patients with metastatic triple-negative breast cancer who are not candidates for immunotherapy. This approval will bring a much-needed treatment option for these patients."

Arlene Brothers, Executive Director, Triple Negative Breast Cancer Foundation, said: "For seven out of 10 patients with metastatic triple-negative breast cancer who are not candidates for immunotherapy, chemotherapy has remained the only treatment option. Today’s approval of Datroway means that for the first time, these patients will have a new standard of care beyond traditional chemotherapy at the outset of their treatment."

Dave Fredrickson, Executive Vice President, Oncology Haematology Business Unit, AstraZeneca, said: "Triple-negative breast cancer is notoriously difficult to treat. Patients with metastatic disease, especially those who are unable to receive immunotherapy, urgently need more effective, durable and tolerable treatment options, which extend survival. With today’s approval, we are proud to bring Datroway to a broad population of advanced triple-negative breast cancer patients and we continue to study its promise as a mainstay treatment across tumours, stages and settings."

Ken Keller, Global Head of Oncology Business, and President and CEO, Daiichi Sankyo, Inc., said: "As the first antibody drug conjugate to demonstrate a median overall survival of two years in the 1st-line metastatic setting of triple-negative breast cancer, Datroway has the potential to redefine the treatment landscape for these patients. With this approval, Datroway is now approved for three indications in the US, including two for breast cancer, underscoring its potential to play an important role across tumour types."

In the trial, Datroway demonstrated a statistically significant and clinically meaningful 5.0-month improvement in median overall survival (OS) (hazard ratio [HR] 0.79; 95% confidence interval [CI] 0.64-0.98; p=0.0290) and a 43% reduction in patients’ risk of disease progression or death (HR 0.57; 95% CI 0.47-0.69; p<0.0001) compared to chemotherapy as 1st-line treatment in this patient population. Datroway was also associated with more robust treatment responses, including an objective response rate (ORR) of 64% compared to an ORR of 30% with chemotherapy.1

The safety profile of Datroway in TROPION-Breast02 was consistent with previous clinical trials of Datroway in breast cancer.

This application was reviewed under Project Orbis, which provides a framework for concurrent submission and review of oncology medicines among participating international partners. As part of Project Orbis, reviews are ongoing in Australia, Canada, Singapore and Switzerland. This initiative is designed to bring effective cancer treatments to patients as early as possible. Additional reviews are underway in the EU, China and Japan.

Based on the results of TROPION-Breast02, datopotamab deruxtecan (Datroway) has been included in the NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines) as a Category 1 Preferred 1st-line treatment option for patients with metastatic TNBC who are not candidates for immunotherapy. See NCCN Guidelines for detailed recommendations.2

Datroway is a specifically engineered TROP2-directed DXd antibody drug conjugate (ADC) discovered by Daiichi Sankyo and being jointly developed and commercialised by AstraZeneca and Daiichi Sankyo.

Notes

Triple-negative breast cancer
TNBC accounts for approximately 15% of all breast cancer cases, with an estimated 345,000 diagnoses globally each year.3,4 In the US, an estimated 32,000 to 48,000 cases of TNBC were diagnosed in 2025, and approximately 11,000 patients with TNBC receive treatment in the 1st-line setting each year.5-7 TNBC is diagnosed more frequently in younger and premenopausal women, and is more prevalent in Black and Hispanic women.8-10 Metastatic TNBC is the most aggressive type of breast cancer and has one of the worst prognoses, with median OS of just 12 to 18 months and only about 15% of patients living five years following diagnosis.8,11,12

While some breast cancers may test positive for oestrogen receptors, progesterone receptors or overexpression of HER2, TNBC tests negative for all three.8 Due to its aggressive nature and absence of common breast cancer receptors, TNBC is characteristically difficult to treat.8 For patients with metastatic disease with PD-L1 expressing tumours, the addition of immunotherapy to chemotherapy has improved outcomes in the 1st-line setting.13,14 However, for approximately 70% of patients with metastatic TNBC who are not candidates for immunotherapy, prior to the approval of Datroway, chemotherapy was the only approved 1st-line treatment.15

TROP2 is a protein broadly expressed in several solid tumours, including TNBC.16 TROP2 is associated with increased tumour progression and poor survival in patients with breast cancer.17,18

TROPION-Breast02
TROPION-Breast02 is a global, multicentre, randomised, open-label Phase III trial evaluating the efficacy and safety of Datroway versus investigator’s choice of chemotherapy (paclitaxel, nab-paclitaxel, capecitabine, carboplatin or eribulin) in patients with previously untreated locally recurrent inoperable or metastatic TNBC for whom immunotherapy was not an option. This included patients whose tumours did not express PD-L1 as well as patients with PD-L1 expressing tumours who could not receive immunotherapy due to prior exposure in early-stage disease, comorbidities or immunotherapy not being accessible in their geography. Enrolment included patients with de novo or recurrent disease, regardless of disease-free interval, and those with poor prognostic factors such as stable brain metastases.

The dual primary endpoints of TROPION-Breast02 are progression-free survival (PFS) as assessed by blinded independent central review and OS. Secondary endpoints include PFS as assessed by investigator, ORR, duration of response, disease control rate, pharmacokinetics and safety.

TROPION-Breast02 enrolled 644 patients at sites in Africa, Asia, Europe, North America and South America. For more information, visit ClinicalTrials.gov.

Datroway
Datroway (datopotamab deruxtecan; datopotamab deruxtecan-dlnk in the US only) is a TROP2-directed ADC. Designed using Daiichi Sankyo’s proprietary DXd ADC Technology, Datroway is one of seven DXd ADCs in the oncology pipeline of Daiichi Sankyo, and one of the most advanced programmes in AstraZeneca’s ADC scientific platform. Datroway is comprised of a humanised anti-TROP2 IgG1 monoclonal antibody, developed in collaboration with Sapporo Medical University, attached to a number of topoisomerase I inhibitor payloads (an exatecan derivative, DXd) via tetrapeptide-based cleavable linkers.

Datroway is also approved in more than 40 countries/regions worldwide for the treatment of adult patients with unresectable or metastatic HR-positive, HER2-negative (IHC 0, IHC 1+ or IHC 2+/ISH-) breast cancer who have received prior endocrine-based therapy and chemotherapy for unresectable or metastatic disease based on results from the TROPION-Breast01 trial.

Datroway is available in the US under accelerated approval for the treatment of adult patients with locally advanced or metastatic EGFR-mutated non-small cell lung cancer (NSCLC) who have received prior EGFR-directed therapy and platinum-based chemotherapy based on results from the TROPION-Lung05 and TROPION-Lung01 trials. Continued approval for this indication in the US may be contingent upon verification and description of clinical benefit in a confirmatory trial.

Datroway clinical development programme
A comprehensive global clinical development programme is underway with more than 20 trials evaluating the efficacy and safety of Datroway across multiple cancers, including NSCLC, TNBC and urothelial cancer. The programme includes eight Phase III trials in lung cancer, five Phase III trials in breast cancer, and one Phase III trial and one Phase II/III trial in urothelial cancer evaluating Datroway as a monotherapy and in combination with other cancer treatments in various settings.

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(Press release, AstraZeneca, MAY 26, 2026, View Source [SID1234666048])

Mercy BioAnalytics to Present Data at ASCO Evaluating Clinical Performance of a Blood-Based Lung Cancer Early Detection Assay in Biospecimens from the National Lung Screening Trial

On May 26, 2026 Mercy BioAnalytics, Inc., a pioneer in blood-based early cancer detection, reported that it will present two abstracts at the 2026 ASCO (Free ASCO Whitepaper) Annual Meeting highlighting results from studies using biospecimens from the National Lung Screening Trial (NLST) repository.

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The NLST was an NCI-sponsored randomized controlled trial that demonstrated a significant mortality benefit associated with annual low-dose CT-based screening. NLST established a biospecimen repository for the purpose of enabling the validation of early detection lung cancer biomarkers that might augment or replace low-dose CT (LDCT).1 To date, nearly 900 requests for NLST data or biospecimens have been approved.2 To our knowledge, Mercy’s ASCO (Free ASCO Whitepaper) presentation will be the first use of blood specimens from NLST subjects for preliminary validation of early detection lung cancer biomarkers. This work represents an important milestone in advancing blood-based approaches for lung cancer screening and lung nodule triage in elevated-risk subjects.

The first study reports results from a blinded evaluation of a novel blood-based lung cancer screening assay in elevated-risk subjects from the NLST. In this dataset, the blood-based screening assay showed similar sensitivity to low-dose CT across two annual screening encounters and detected lung cancers that were missed by low-dose CT, supporting further evaluation of the assay for lung cancer screening in the elevated-risk population.

The second study reports results from a blinded evaluation of a novel blood-based pulmonary nodule triage assay in elevated-risk subjects from the NLST. Six percent of LDCT-screened subjects in NLST were scored as 3 or 4A using the Lung-RADS framework. Despite a 4% prevalence of cancer in this population, immediate diagnostic workup is not recommended. Mercy’s blood-based assay exhibited 43% sensitivity for the detection of lung cancer in these subjects, supporting further evaluation as a reflex approach for LDCT-detected pulmonary nodules.

"The results of the National Lung Screening Trial documenting a 20% decrease in lung cancer mortality with low-dose CT has led to practice changing recommendations with screening now recommended in high-risk groups. Mercy’s encouraging preliminary results are exactly why the NCI set up the NLST biospecimen repository: to enable validation of promising blood biomarkers. A blood test like Mercy’s could increase lung cancer screening uptake and make evaluation of pulmonary nodules more precise, potentially leading to more lives saved," said Dr. Christine Berg, M.D. the now retired NCI lead investigator on the NLST. "I am excited about these results. I have the good fortune to serve on the Clinical Advisory Board at Mercy and observed the meticulous care with which this work was done."

These results support further evaluation which is now underway of Mercy’s blood-based approaches to lung cancer screening and risk stratification of LDCT-detected pulmonary nodules.

Mercy is continuing to advance blood-based approaches designed to expand access to earlier detection and improve decision-making in lung cancer screening and follow-up.

Presentation details for the two accepted abstracts will be available through the ASCO (Free ASCO Whitepaper) Annual Meeting program and Mercy’s communications channels as the meeting approaches.

(Press release, Mercy BioAnalytics, MAY 26, 2026, View Source [SID1234666064])

RenovoRx Announces Promising Pharmacokinetic Data Using the TAMP™ Platform Presented at the 2026 ASCO Annual Meeting

On May 26, 2026 RenovoRx, Inc. ("RenovoRx" or "the Company") (Nasdaq: RNXT), a life-sciences company developing innovative targeted oncology therapies and commercializing RenovoCath, a patented, FDA-cleared drug-delivery device, reported that an abstract from a pharmacokinetic (PK) and pharmacodynamic sub-study of its ongoing Phase III TIGeR-PaC clinical trial has been published online in connection with the 2026 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting on May 29 – June 2, 2026.

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The abstract, entitled "The TIGeR-PaC Phase 3 Clinical Trial Examining Intra-Arterial Gemcitabine Versus Intravenous Gemcitabine: Pharmacokinetic and Pharmacodynamic Sub-Study," is a sub-study of the Phase III TIGeR-PaC clinical trial in locally advanced pancreatic cancer. The abstract evaluates the TAMP (Trans-Arterial Micro-Perfusion) platform for targeted intra-arterial delivery of gemcitabine via RenovoCath, (the Company’s lead investigational product candidate, known as IAG) and its potential to reduce systemic levels of gemcitabine and increase levels of its inactive metabolite compared with IV gemcitabine.

Results showed that IAG administration was associated with a direct correlation between increased metabolite levels and reduced CA 19-9, a biomarker commonly used to assess potential chemotherapy response. By decreasing systemic levels of gemcitabine, through limited systemic exposure and rapid conversion to an inactive metabolite, this drug-delivery approach may both increase local drug potency and reduce the negative side effects common to patients receiving gemcitabine via IV delivery for the treatment of pancreatic cancer. The PK and pharmacodynamic analyses were performed from a total of 16 patients across six TIGeR-PaC trial sites.

"This study suggests that enhancing local drug potency while reducing systemic exposure with IAG may increase efficacy while minimizing toxicity, addressing a key limitation of many therapies," said co-author Dr. Reza Nazemzadeh of Atrium Health Levine Cancer Institute, Charlotte, NC. "By lowering circulating drug levels, the approach has the potential to reduce side effects and improve patient tolerability, representing a promising step toward more precise and patient-centered cancer care."

The 2026 ASCO (Free ASCO Whitepaper) Annual Meeting is being held May 29 – June 2, 2026, in Chicago, Illinois.

Abstract Details:
Online Publication Date & Time: May 21, 2026, at 5:00 P.M. ET
Location: Online
Number for Publication: E16463
Title: The TIGeR-PaC Phase 3 Clinical Trial Examining Intra-Arterial Gemcitabine Versus Intravenous Gemcitabine: Pharmacokinetic and Pharmacodynamic Sub-Study

(Press release, Renovorx, MAY 26, 2026, View Source [SID1234666081])

Corbus Pharmaceuticals Reports Updated CRB-701 Phase 1/2 Clinical Data Demonstrating Robust Activity in 2L Oropharyngeal and Cervical Cancers

On May 26, 2026 Corbus Pharmaceuticals Holdings, Inc. (NASDAQ: CRBP) ("Corbus" or the "Company") reported updated data from its Phase 1/2 clinical study (NCT06265727) of CRB-701 (SYS6002), a next-generation Nectin-4 targeted antibody drug conjugate (ADC). The new data demonstrate robust activity in the second line (2L) setting of two solid tumor types that express high levels of Nectin-4 and are primarily driven by human papilloma virus (HPV): oropharyngeal squamous cell carcinoma (OPSCC) and cervical cancer. These findings will be presented at the upcoming 2026 American Society for Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting being held May 29 – June 2, 2026, in Chicago.

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The ongoing multi-center Phase 1/2 study is being conducted in the U.S. and Europe. The data reported today derives from an April 1, 2026 data cut of the Phase 1/2 study with a total safety population of 317 patients encompassing all tumor types and all doses. A total of 75 patients with HNSCC were enrolled at the 2.7 mg/kg and 3.6 mg/kg doses, of whom 71 were efficacy evaluable while 4 did not have post-baseline scans. A total of 72 patients with cervical cancer were enrolled at the 2.7 mg/kg and 3.6 mg/kg doses, of whom 70 were efficacy evaluable while 2 did not have post-baseline scans.

Safety (n=317)
CRB-701 continued to be safe and well tolerated, consistent with findings reported at the ESMO (Free ESMO Whitepaper) 2025 data cut. The most common treatment-related adverse events (TRAEs) occurring in more than 20% of participants were keratitis (49.2%), alopecia (25.6%), fatigue (22.4%), and dysgeusia (19.9%). Grade 3 adverse events (AEs) were reported in 19.2% of patients, and Grade 4 AEs were reported in 0.9% of patients. There were no Grade 5 events reported. The incidence of peripheral neuropathy remained low at 7.3%, with all events limited to Grade 1 or 2 severity. Skin-related AEs, excluding alopecia, were at 24%. There was only one Grade 3 event (0.3%) reported. There were no skin Grade 4 or 5 events, and no reported cases of Stevens-Johnson Syndrome (SJS) or toxic epidermal necrolysis (TEN). Overall, treatment discontinuations related to CRB-701 remained low at 2.8%. Ocular toxicities, a well-established side effect in multiple approved ADCs, continued to be manageable through prophylactic eye care interventions and dose reductions/interruptions. Ocular AEs were reported in 66.2% of participants, with the vast majority being transient in nature. Grade 3 events were reported in 12.6% of participants and only one Grade 4 event (0.3%) was reported involving exacerbation of pre-existing punctate keratitis and microcysts that resolved to baseline within six weeks. Discontinuations due to ocular AEs remained markedly low at 1.9%.

Efficacy in Patients with HNSCC Dosed with CRB-701 at 2.7 mg/kg or 3.6 mg/kg (total n=71)

OPSCC (n=41)
Dose 2.7 mg/kg (n=20) 3.6 mg/kg (n=21)
cORR* 20.0% (4/20) 42.9% (9/21)
DCR** 90.0% (18/20) 85.7% (18/21)
DoR (months) ongoing 4.8 6.3
PFS (months) ongoing 4.2 5.6
Non-Oropharyngeal HNSCC (n=30)
Dose 2.7 mg/kg (n=14) 3.6 mg/kg (n=16)
cORR* 7.1% (1/14) 0.0% (0/16)
DCR** 57.1% (8/14) 62.5% (10/16)
DoR (months) 4.4 NA
PFS (months) 2.3 2.7
HNSCC Biomarkers
HPV status was determined for 97.3% of the HNSCC participants in the 2.7 mg/kg and 3.6 mg/kg cohorts.
In line with published epidemiology, 57.3% of enrolled HNSCC patients were HPV+, with 85.4% of oropharyngeal patients being HPV+.
8 of the 9 patients who achieved PR in the OPSCC cohort were HPV+. In contrast, no confirmed PRs were observed in non-OPSCC HNSCC at the corresponding dose.
In-line with published literature, higher Nectin-4 levels were associated with HPV+ HNSCC.
In-depth biomarker analysis will be presented at a future conference.
*Confirmed objective response rate (cORR) calculated using patients’ confirmed best overall response (BOR) per RECISTv1.1**Disease control rate (DCR) calculated by summing numbers of response-evaluable patients who achieve a BOR of complete response (CR), partial response (PR) or stable disease (SD).

Efficacy in Patients with Cervical Cancer Dosed with CRB-701 at 2.7 mg/kg and 3.6 mg/kg

Cervical Cancer (n=70)
Dose 2.7 mg/kg (n=38) 3.6 mg/kg (n=32)
cORR* 18.4% (7/38) including 1 CR 34.4% (11/32) including 2 CRs
DCR** 55.3% (21/38) 75.0% (24/32)
DoR (months) ongoing 6.8 8.0
PFS (months) ongoing 2.8 4.3
*Confirmed objective response rate (cORR) calculated using patients’ confirmed best overall response (BOR) per RECISTv1.1**Disease control rate (DCR) calculated by summing numbers of response-evaluable patients who achieve a BOR of complete response (CR), partial response (PR) or stable disease (SD).

"These data provide important clarity on the clinical and commercial path for CRB-701 in 2L oropharyngeal and 2L cervical cancers, indications that are associated with HPV infection and high expression of Nectin-4, and for which approved and other investigational drugs have shown limited efficacy," said Yuval Cohen, Ph.D., Chief Executive Officer of Corbus. "In addition, these findings further validate our clinical development strategy aimed at targeting solid tumors outside of metastatic urothelial cancer. We look forward to advancing these programs into registrational trials starting with TEMPO-1, our upcoming OPSCC study initiating this summer."

"OPSCC, which now represents a growing majority of HNSCC cases treated in the U.S., continues to rise in incidence. Largely driven by HPV, OPSCC primarily affects men in their 50s and 60s with little or no history of smoking or heavy alcohol use. Approximately 40-50% of HNSCC patients that reach 2L have OPSCC with persistent, recurrent, or metastatic disease that remains incurable with current treatment options, representing a growing unmet need," said Glenn J. Hanna, M.D., Director of the Center for Cancer Therapeutic Innovation at Dana-Farber Cancer Institute. "A targeted therapy for this patient population—particularly one directed against the validated target Nectin-4—could represent a significant advance in care. I look forward to seeing how CRB-701 performs in a late-stage clinical study involving this underserved patient population."

Corbus is on track to initiate a registrational study of CRB-701 in 2L OPSCC ("TEMPO-1") in the summer of 2026. Broad alignment was reached with the U.S. Food and Drug Administration (FDA) on the trial design for a randomized controlled study (n=250), which will explore the efficacy and safety of CRB-701 compared to investigator’s choice of monotherapy with overall response rate (ORR) as the primary endpoint for potential accelerated approval and potential full approval based on overall survival (OS) benefit. Similarly, broad alignment was reached with the FDA regarding the trial design for a randomized controlled study of CRB-701 in 2L cervical cancer.

CRB-701 2026 ASCO (Free ASCO Whitepaper) Data Presentation Details
The oral presentation titled, "A phase 1/2 study of the next-generation Nectin-4-targeting antibody drug conjugate CRB-701 (SYS6002) in patients with recurrent or metastatic cervical cancer," will be presented by Professor Yohann Loriot, Gustave Roussy (Paris) on Friday, May 29 at 4:57 p.m. CDT (Abstract #5508).

The poster presentation titled, "A phase 1/2 study of the next-generation Nectin-4-targeting antibody drug conjugate CRB-701 (SYS6002) in patients with recurrent or metastatic head and neck squamous cell carcinoma," will be presented by Charlene Mantia, M.D., Dana-Farber Cancer Institute (Boston) on Saturday, May 30 at 4:30 p.m. CDT (Abstract #6062/Poster #519).

Pre-2026 ASCO (Free ASCO Whitepaper) Conference Call and Webcast Registration Details
Corbus will host a live conference call and webcast today, Tuesday, May 26, 2026, at 8:00 a.m. EDT to review the data. To register for the webcast: click here.

Investors Dial 1-877-704-4453
Int’l Investors Dial 1-201-389-0920
Conference ID 13760531
CallMe: click here

2026 ASCO (Free ASCO Whitepaper) HNSCC KOL Event
Corbus will host an in-person and virtual KOL event during ASCO (Free ASCO Whitepaper) 2026 to discuss CRB-701 development in OPSCC. The event will be held at Marriott Marquis Chicago starting at 6:30 a.m. CDT on Monday, June 1, 2026.

Date: Monday, June 1, 2026
Time: 6:30 a.m. CDT
Location: Marriott Marquis Chicago
Participants: Corbus Management Team, joined by leading HNSCC Experts:
Ari Rosenberg, M.D., University of Chicago
Glenn Hanna, M.D., Dana-Farber Cancer Institute
Cesar Augusto Perez Batista, M.D., Sarah Cannon Research Institute

A live question-and-answer session will follow the formal presentation. To register for the KOL event, click here. A replay of the event will also be available on the Corbus website.

About CRB-701
CRB-701 (SYS6002) is a next-generation antibody drug conjugate (ADC) targeting Nectin-4, that contains a site-specific, cleavable linker and a homogenous drug antibody ratio of 2, using MMAE as the payload. Nectin-4 is a clinically validated, tumor-associated antigen in urothelial cancer and highly expressed in other tumor types such as cervical and HNSCC. The FDA has granted two Fast Track designations to CRB-701 in HNSCC and cervical cancer.

(Press release, Corbus Pharmaceuticals, MAY 26, 2026, View Source [SID1234666049])