Uncategorized – Page 421 – 1stOncology™: Cancer Intelligence Service

Aktis Oncology Reports First-in-Human Clinical Imaging and Dosimetry Data for AKY-2519 Demonstrating Robust Tumor Uptake and Limited Normal Tissue Exposures in Patients with B7-H3 Expressing Tumors

On May 21, 2026 Aktis Oncology, Inc. (NASDAQ:AKTS) (Aktis or the Company), a clinical-stage oncology company focused on expanding the breakthrough potential of targeted radiopharmaceuticals to large populations, including those not addressed by existing platform technologies, reported first-in-human clinical imaging and dosimetry data for AKY-2519, a miniprotein radioconjugate targeting B7-H3 expressing tumors. The data from two separate assessments of AKY-2519 – a clinical imaging and dosimetry assessment in patients with mCRPC and a clinical imaging assessment in patients with various solid tumor types – demonstrated robust tumor uptake and limited normal tissue exposure. These findings, which supported the advancement of a broad clinical development program for AKY-2519, will be presented in two poster presentations at the upcoming 2026 ASCO (Free ASCO Whitepaper) Annual Meeting, being held May 29 – June 2, 2026, in Chicago.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

Schedule Your 30 min Free Demo!

"We’re excited to report the first clinical imaging and dosimetry data for AKY-2519, which offer a potentially differentiated therapeutic option for patients with B7-H3 expressing tumors, including mCRPC, lung cancer, and colorectal cancer, among others," said Matthew Roden, Ph.D., President and Chief Executive Officer at Aktis. "These data informed the design of our ongoing Phase 1b clinical trial in patients with mCRPC and a second Phase 1b trial of AKY-2519 in various B7-H3 expressing tumor types, which we expect to initiate in the second half of this year. The broad development opportunity for AKY-2519, our second clinical-stage program for multiple tumor types, exemplifies our vision to bring targeted radiopharmaceuticals to large patient populations with significant unmet need."

Akos Czibere, M.D., Ph.D., Chief Medical Officer at Aktis commented, "These first-in-human clinical imaging and dosimetry data suggest the potential of AKY-2519 to expand targeted radiopharmaceuticals to broader patient populations while also offering a potentially important new radiopharmaceutical option for the mCRPC patient population. The robust tumor uptake and retention and low normal tissue uptake consistently seen with AKY-2519 in these assessments gives us an initial understanding of its potential to kill cancer cells while minimizing normal-tissue radiation exposure. Moreover, the low predicted dose in salivary glands suggests AKY-2519’s unique potential as a B7-H3-targeted agent for mCRPC versus PSMA-targeting agents."

B7-H3 is highly expressed in mCRPC, lung, colorectal and various other solid tumor types, with limited expression in normal tissues. High tumor expression of B7-H3 has been shown to be associated with poor prognosis and lack of response to certain therapies in multiple tumor types. AKY-2519 is the second clinical-stage targeted miniprotein radioconjugate discovered and developed from Aktis’ proprietary platform. The program includes [64Cu]Cu-AKY-2519 for imaging with copper-64 (64Cu) and [225Ac]Ac-AKY-2519 for therapeutic use with actinium-225 (225Ac).

Aktis is currently enrolling patients in an mCRPC-dedicated Phase 1b trial of AKY-2519 in PLUVICTO-naïve and PLUVICTO-experienced patients, with preliminary data anticipated in 2027. The Company is on track to initiate a second Phase 1b trial of AKY-2519 in other B7-H3 expressing solid tumors in the second half of 2026. Aktis’ lead program, AKY-1189, a miniprotein radioconjugate targeting Nectin-4 expressing tumors, is currently being evaluated in a Phase 1b trial, with preliminary data expected in the first quarter of 2027.

About the AKY-2519 ASCO (Free ASCO Whitepaper) data presentations

Poster title: AKY-2519, a novel B7-H3–targeted radioconjugate, demonstrates a differentiated biodistribution profile with low normal tissue exposure and robust tumor doses in patients with mCRPC
Poster #: 234 / Abstract #: 3097 / Date & Time: Saturday, May 30, 1:30 – 4:30 p.m. CDT

Assessment background and methods

Conducted at the Nuclear Medicine Research Infrastructure (NuMeRI) at the University of Pretoria and Steve Biko Academic Hospital, South Africa, the assessment evaluated the biodistribution and dosimetry of AKY-2519, using [68Ga]Ga-AKY-2519 and low dose, non-therapeutic [177Lu]Lu-AKY-2519 as imaging surrogates in 16 patients with mCRPC. In the first part of the assessment, patients were given [68Ga]Ga-AKY-2519 and imaged using PET/CT at 30, 60, and 90 – 150 minutes to evaluate normal tissue distribution, tumor uptake and comparison with uptake of FDA-approved diagnostic PSMA-11. In the second part of the imaging assessment, patients were given low-dose, non-therapeutic [177Lu]Lu-AKY-2519 and imaged using SPECT/CT at 3, 24, and 144 hours to evaluate dosimetry (mean absorbed dose) and to estimate predicted [225Ac]Ac-AKY-2519 absorbed doses, at a therapeutic administration schedule of 8 MBq x4, in normal tissues and tumors.

Data highlights

Safety and tolerability

Administration of AKY-2519 was generally well tolerated, with no adverse events or infusion-related reactions reported with either [68Ga]Ga-AKY-2519 or [177Lu]Lu-AKY-2519.

Imaging and dosimetry results

Predicted absorbed doses of AKY-2519 in key normal tissues (bone marrow, liver, kidneys, salivary glands) were estimated to be favorable when compared to reference clinical benchmarks.
Notably, the predicted absorbed dose of AKY-2519 to the salivary glands was lower compared to approved radiopharmaceuticals.

Table 1. Predicted [225Ac]Ac-AKY-2519 absorbed doses in critical normal tissues

Normal Tissue
Mean Absorbed Dose Coefficient
(225Ac)
Predicted
Absorbed Dose at 8 MBq x 4

(n=12)a
GyRBE=5/MBq(SD)
GyRBE=5
Bone marrow 0.04 (0.02) 1.3
Liver 0.31 (0.10) 9.9
Kidneys 0.50 (0.17) 16
Salivary glands 0.13 (0.04) 4.2
a[177Lu]Lu-AKY-2519 was used as a surrogate for estimation of absorbed doses with [225Ac]Ac-AKY-2519. Of the 16 patients with [177Lu]Lu-AKY-2519 dosimetry data available, 12 had sufficient data for conversion to [225Ac]Ac-AKY-2519; RBE, relative biological effectiveness; SD, standard deviation.

AKY-2519 demonstrated robust tumor uptake and retention in tumors for at least 6 days after administration.
Predicted absorbed doses of AKY-2519 to prospectively selected tumors, including involved prostate and seminal vesicles and nodal and bony metastases, were within expected therapeutic ranges for approved radiopharmaceuticals.
The combined findings of predicted absorbed doses in tumors and normal tissues suggest a wide therapeutic index and a favorable profile for AKY-2519 compared to approved radiopharmaceuticals.

Table 2. Estimated tumor absorbed doses of [225Ac]Ac-AKY-2519 in mCRPC lesions

Lesion Location Evaluable
Patients Mean Absorbed Dose Coefficienta(225Ac)
Mean Absorbed Dose Coefficient with PVC (225Ac)
Predicted
Absorbed Dose at 8 MBq x 4
Predicted Absorbed Dosebat 8 MBq x 4 with PVC
GyRBE=5/MBq(SD)
GyRBE=5/MBq(SD)
GyRBE=5
GyRBE=5
Involved prostate ± seminal vesicles 8 2.6 (1.2) N/Ac 83 (39) N/Ac
Nodal metastases 5 4.4 (2.8) 8.4 (4.2) 141 (88) 268 (134)
Bony metastases 6 1.5 (0.8) 3.8 (1.8) 48 (25) 121 (57)
aWhere multiple regions of interest (ROIs) of the same category were available in a single patient (nodal or bony metastasis), the highest value was utilized. bProjected absorbed dose estimates are calculated based on the corresponding raw dose coefficient for the ROI. cPartial volume correction (PVC) was not applied for ROI analysis of involved prostate due to spillover activity from adjacent bladder. SD, standard deviation

AKY-2519 and PSMA-11 comparison

Distribution of tumor uptake appears comparable between [68Ga]Ga-AKY-2519 and [68Ga]Ga-PSMA-11 at the standard 60 minutes measurement time point, with tumor uptake with [68Ga]Ga-AKY-2519 increasing over time.

Poster Presentation 2: First-in-Human PET/CT imaging with [69Ga]Ga-AKY-2519, a B7-H3 Targeted Miniprotein Conjugate, to demonstrate tumor uptake and normal tissue exposure across various advanced solid tumors
Poster #: 235 / Abstract #: 3098 / Date & Time: Saturday, May 30, 1:30 – 4:30 p.m. CDT

Assessment background and methods

Conducted by the Department of Nuclear Medicine, University of Duisburg-Essen and German Cancer Consortium (DKTK), Universitätsklinikum Essen (University Hospital Essen), Essen, Germany, the assessment evaluated the biodistribution and tumor uptake of [68Ga]Ga-AKY-2519 in patients with advanced or metastatic disease in a variety of solid tumors, including prostate, lung, colorectal, and other tumor types (n=18). Following intravenous administration of [68Ga]Ga-AKY-2519 patients were imaged with PET/CT and SUV (standardized uptake value) measurements were taken to assess tumor uptake and normal tissue distribution at 15, 60 and 120 minutes.

Data highlights

Safety and tolerability

Administration of [68Ga]Ga-AKY-2519 was generally well tolerated, with no adverse events or infusion-related reactions reported.

Imaging results

Robust uptake of [68Ga]Ga-AKY-2519 as measured by SUVmax was observed across multiple tumor types, including prostate, non-small cell lung cancer (NSCLC), small cell lung cancer (SCLC), and rectal cancer at various time points out to 120 minutes with representative patients showing:
Prostate cancer: SUVmax = 33.9-37.4;
NSCLC: SUVmax = 17.5-21.5;
SCLC: SUVmax = 15.4; and
Rectal cancer: SUVmax = 15.3.
In prostate cancer, high [68Ga]Ga-AKY-2519 tumor uptake was consistently observed across metastatic disease sites with the most intense uptake observed in bone and visceral metastases.

Table 3. Uptake of [68Ga]Ga-AKY-2519 (120 min post infusion) in multiple metastatic disease sites
from patients with prostate cancer (n=7)

Bone Metastases Lymph Node Metastases Visceral Metastases
Median SUVmax 40.4 13.8 31.0
Median SUVpeak 25.0 6.5 22.2
Median SUVmean 16.1 5.1 18.7
SUV, standard uptake value

PET/CT imaging 120 min after [68Ga]Ga-AKY-2519 injection showed low uptake in critical normal tissues.

Table 4. Uptake of [68Ga]Ga-AKY-2519 (120 min post infusion) in normal tissues of patients with solid tumors (n=18)

Adrenal
Glands Bone
Marrow Kidneys Liver Salivary
Glands Spleen

Median (IQR) SUVmax 17.5
(15.9—19.8) 4.1
(3.3—5.1) 6.7
(6.3—8.7) 22.9
(20.9—30.8) 7.3
(6.4—11.4) 9.2
(7.6—10.4)

Conference call and webcast information
Aktis will host a live conference call and webcast on Wednesday, May 27, 2026, at 8 a.m. ET to discuss the AKY-2519 imaging and dosimetry data with leading clinical investigators, Oliver Sartor, M.D., LCMC Health, Director, Transformational Prostate Cancer Research Center (New Orleans, LA), and Timothy A. Yap, MBBS, Ph.D., Vice President and Head of Clinical Development, Therapeutics Discovery Division; Professor, Department of Investigational Cancer Therapeutics (Phase I Program), University of Texas MD Anderson Cancer Center. To access the conference call, please register here. Registrants will receive the dial-in number and unique PIN. A live webcast of the call will also be available under "Events" in the Investors section of the Aktis Oncology website at investors.aktisoncology.com. The archived webcast will be available for 90 days following the call.

(Press release, Aktis Oncology, MAY 21, 2026, View Source [SID1234665982])

Bicycle Therapeutics to Present Initial Duravelo-2 Data at 2026 ASCO Annual Meeting

On May 21, 2026 Bicycle Therapeutics plc (NASDAQ: BCYC), a pharmaceutical company pioneering a new and differentiated class of therapeutics based on its proprietary bicyclic peptide (Bicycle) technology, reported the presentation of initial data from the randomized Phase 2 trial (Duravelo-2) evaluating zelenectide pevedotin (zelenectide) in previously untreated patients with metastatic urothelial cancer (mUC), demonstrating encouraging response rates and a potentially differentiated safety profile both as a monotherapy and in combination with pembrolizumab. In addition, updated data from the Phase 1 trial (Duravelo-1) in previously untreated, cisplatin-ineligible mUC patients demonstrated encouraging median progression-free survival (PFS) comparable to published data for standard of care (SOC). The data announced today will be presented at the 2026 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting, taking place May 29 – June 2 in Chicago.

"Despite recent advances for the treatment of bladder cancer, there remains an urgent need for more tolerable therapies. For instance, published clinical data for the current SOC for mUC demonstrate a significant number of tolerability-related drug discontinuations, and high rates of neuropathy and skin toxicities. In contrast, the initial Duravelo-2 data shared today demonstrate that zelenectide in combination with pembrolizumab continues to show response rates comparable to published data for SOC for mUC, while potentially offering substantially lower toxicity and improved tolerability for patients. We have now tested zelenectide as a monotherapy or in combination with pembrolizumab in more than 600 patients and have consistently observed lower rates and severity of neuropathy and skin toxicities," said Bicycle CEO Kevin Lee, Ph.D. "We believe that the extensive data we have generated in patients continue to demonstrate the unique nature of Bicycle molecules as targeting agents that offer a potentially differentiated tolerability profile to antibody-based approaches. We are excited to continue to explore these advantages with novel targets and novel payloads in our mission to help patients not only live longer but live well. Meanwhile, the Duravelo-2 trial has been converted into a randomized Phase 2 trial and we look forward to sharing further results in the second half of 2026."

Initial Duravelo-2 Data Results

Zelenectide is a Bicycle Drug Conjugate (BDC) targeting Nectin-4, a well-validated tumor antigen. The Duravelo-2 trial evaluated two doses of zelenectide – 5mg/m2 weekly (5mg dose) and 6mg/m2 (6mg dose) two weeks on, one week off – in combination with 200mg of pembrolizumab once every three weeks in previously untreated patients with mUC (Cohort 1). Bicycle reached regulatory alignment on the zelenectide 6mg dose as optimal both in combination with pembrolizumab and as a monotherapy. Cohort 1 data were extracted for the interim analysis at Week 27, on July 23, 2025. At the time of the data cut, the median PFS was not mature, and the results at the optimal dose showed:

65% (17/26) overall response rate (ORR) regardless of confirmation and blinded independent central review (BICR) confirmed ORR of 58% (15/26) at the 27-week cutoff. Subsequent to the 27-week cutoff, an additional confirmed BICR response was observed, which would result in an ORR of 62% (16/26).
Median duration of treatment (mDOT) was 6.3 months (0.7-10.6).
65% of patients remain on treatment.
Median relative dose intensity in patients receiving the optimal dose was 97%.
Low rates of zelenectide-related adverse events (AEs) of clinical interest were observed, including peripheral neuropathy, sensory (33%); skin reactions (17%); eye disorders (10%). There were no reported instances of zelenectide-related hyperglycemia.
No zelenectide-related severe skin reactions of any grade were reported.
The single Grade 3 zelenectide-related AE of clinical interest, peripheral neuropathy, resolved to Grade ≤1. There were no Grade 4 or Grade 5 zelenectide-related AEs of clinical interest.
Notably, only one patient at the optimal dose discontinued therapy due to a zelenectide-related AE at the time of the data cut in Cohort 1.
The Duravelo-2 trial also evaluated the 5mg dose and 6mg dose regimens of zelenectide as a monotherapy in mUC patients with one or more prior lines of systemic therapy (Cohort 2). Cohort 2 data were extracted for the interim analysis at Week 27, on June 14, 2025. At the time of the data cut, the median PFS was not mature, and the results at the optimal dose showed:

37% (10/27) ORR regardless of confirmation and 30% confirmed ORR (8/27) was achieved among efficacy-evaluable patients. Of the confirmed responses, 3 (11%) were complete responses (CRs) and 5 (19%) were partial responses (PRs).
mDOT was 4.8 months (1.3-10.1).
31% of patients remain on treatment.
Median relative dose intensity in patients receiving the optimal dose was 86%.
Low rates of zelenectide-related AEs of clinical interest were observed, including peripheral neuropathy (38%); skin reactions (28%); eye disorders (10%); and hyperglycemia (3%).
There were no Grade 4 or Grade 5 zelenectide-related AEs of clinical interest.
Notably, no zelenectide-related severe skin reactions of any grade were reported, and no treatment discontinuations occurred at the optimal dose.
The company plans to share additional Duravelo-2 data from the randomized Phase 2 trial in the second half of 2026.

Updated Duravelo-1 Data Results

The company also announced the presentation of updated Phase 1 Duravelo-1 data evaluating zelenectide in mUC, including monotherapy data in enfortumab vedotin (EV)-naïve patients and in combination with 200mg of pembrolizumab once every three weeks in previously untreated cisplatin-ineligible patients. Both cohorts evaluated zelenectide at the 5mg dose.

Updated results as of the August 1, 2025 data cutoff evaluating zelenectide in combination with pembrolizumab in previously untreated cisplatin-ineligible patients, 45% of whom were classified as Eastern Cooperative Oncology Group (ECOG) performance status of 2, showed:

59% (13/22) ORR regardless of confirmation, 50% confirmed ORR (11/22), and a disease control rate (DCR) of 82%. Of the confirmed responses, 5 (23%) were CRs and 6 (27%) were PRs.
Median PFS was 13.0 months and median duration of response (mDOR) was not mature at the time of the data cutoff.
Updated results as of the August 1, 2025 data cutoff evaluating zelenectide as a monotherapy in EV-naïve recurrent, unresectable mUC patients who had prior anti-programmed death-1/programmed death ligand-1 (PD-1/PD-L1), had disease progression after or were ineligible for platinum-based chemotherapy showed:

38% (20/53) ORR regardless of confirmation, 32% confirmed ORR (17/53) and a DCR of 66%. Of the confirmed responses, 2 (4%) were CRs and 15 (28%) were PRs.
Median PFS was 5.4 months and mDOR was 10.0 months (5.3-16.6) among patients with confirmed responses.
Across all patients, the safety and tolerability profile was consistent with other zelenectide data to date. No new safety signals were observed and there were no Grade 4 or Grade 5 zelenectide-related AEs of clinical interest reported.

The presentations will be made available in the Publications sections of the Bicycle Therapeutics website following each presentation.

(Press release, Bicycle Therapeutics, MAY 21, 2026, View Source [SID1234665917])

Nanobiotix Announces Pricing of Oversubscribed €85m Global Offering

On May 21, 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 pricing of its previously announced global follow-on offering, consisting of (i) a public offering of 225,373 American Depositary Shares ("ADSs"), each ADS representing one ordinary share, €0.03 nominal value per share (each an "Ordinary Share"), of the Company, in the United States (the "U.S. Offering") at an offering price of $38.98 per ADS, and (ii) an offering of (a) 1,959,289 Ordinary Shares and (b) 345,099 pre-funded warrants to subscribe for one Ordinary Share each (the "PFW"), exclusively to "qualified investors" in Europe (including France) within the meaning of Article 2(e) of Regulation (EU) 2017/1129, as amended (the "Prospectus Regulation"), and certain other countries (excluding the United States and Canada) (the "International Offering", together with the U.S. Offering, the "Global Offering"), at an offering price of €33.60 per Ordinary Share and €33.57 per PFW.

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 ("Euronext") 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 "Shareholders’ Meeting"). The subscription price of each PFW is equal to the subscription price per Ordinary Share issued in the International Offering minus €0.03.

The aggregate gross proceeds of the Global Offering are expected to be approximately $98.6 million, equivalent to approximately €85.0 million, of which approximately €73.4 million in respect of the U.S. Offering and the International Offering and €11.6 million in respect of the PFW, before deduction of underwriting commissions in respect of the Global Offering and estimated expenses related to the Global offering, assuming no exercise of the Over-Allotment Option (as defined below) in respect of the Global Offering. If all of the PFW are exercised, the aggregate gross proceeds are expected to be approximately $12k, equivalent to approximately €10k.

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

The Global Offering is subject to an underwriting agreement, which was entered into on May 21, 2026. The underwriting agreement does not constitute a performance guarantee (garantie de bonne fin) within the meaning of Article L. 225-145 of the French Commercial Code (Code de commerce).

Type of Offering

The issuance of 2,184,662 Ordinary Shares (including in the form of ADSs) and 345,099 PFW in the Global Offering has been decided on the date hereof by the Company’s Executive Board, without preferential subscription rights for existing shareholders, pursuant to the delegation granted to it by the Shareholders’ Meeting in its 29th resolution.

Main Terms of the Pre-Funded Warrants

The subscription price of each PFW is €33.57 (corresponding to $38.94), which equal to the subscription price per Ordinary Share issued in the Global Offering minus €0.03.

Each PFW will allow its holder to subscribe to one Ordinary Share at a price of €0.03.

The PFW are exercisable in cash from their date of issue until May 26, 2036.

The PFW are securities giving access to the capital within the meaning of Article L. 228-91 of the French Commercial Code. They will be issued in dematerialized form and held in pure registered form (au nominatif pur) in the securities account opened in the name of the holder thereof in the books of the Company’s account keeper.

No fractional shares shall be issuable upon the exercise of PFW, provided that the number of shares to be delivered in respect of any exercise of one or more PFW pursuant to any exercise notice shall be rounded down to the nearest whole multiple of one share.

If the Company carries out any of the transactions referred to in Articles L. 228-99 and L. 228-101 of the French Commercial Code, the rights of holders of the PFW will be maintained in accordance with said articles.

The PFW will not be admitted to trading on Euronext or on any domestic or foreign securities exchange or nationally recognized trading system. The shares issued upon the exercise of PFW (the "PFW Shares") will be held, at the option of the holder, in registered form (au nominatif) or in bearer form (au porteur). As soon as they are issued, the PFW Shares will be automatically assimilated to the Company’s ordinary shares and will be admitted to trading on Euronext under the same ISIN number.

The PFW holders will be grouped automatically for the defense of their common interests in a masse. The masse will act, in part, through a representative and, in part, through collective decisions of the holders.

Expected Closing

The Global Offering is expected to close on May 26, 2026, subject to the satisfaction of customary closing conditions.

Option to Purchase Additional Shares

In connection with the Global Offering, the Company has granted the underwriters for the Global Offering a 30-day option to purchase additional ADSs, in an amount of up to 15% of the total number of ADSs issued in the Global Offering, on the same terms and conditions as in the Global Offering, in accordance with the delegation granted by Shareholders’ Meeting in its 36th resolution (the "Over-Allotment Option"). The Company will announce the exercise of the Over-Allotment Option and the number ADSs to be issued in connection therewith, if any, as soon as practicable thereafter in a subsequent press release.

Stabilization

In connection with the Global Offering, Jefferies LLC, acting as stabilization agent, may effect transactions with a view to supporting, stabilizing, or maintaining the market price of such securities at a level higher than which might otherwise prevail in the Company’s ADS market. However, there is no assurance that the stabilization agent will take any stabilization action and, if begun, such stabilization action may be ended at any time without prior notice. Any stabilization action or over-allotment shall be carried out in accordance with all applicable rules and regulations and may be undertaken on the Nasdaq Global Select Market.

Estimated Proceeds from the Global Offering

The aggregate gross proceeds from the Global Offering are expected to be approximately $98.6 million, equivalent to approximately €85.0 million, of which approximately €73.4 million in respect of the U.S. Offering and the International Offering and €11.6 million in respect of the PFW, before deducting underwriting commissions in respect of the Global Offering and estimated offering expenses payable by the Company, assuming no exercise of the Over-Allotment Option in connection with the Global Offering. If all of the PFW are exercised, the estimated gross proceeds received by the Company from the Global Offering would be expected to be approximately $12k, equivalent to approximately €10k. If the Company issues additional ADSs pursuant to the exercise in full of the Over-Allotment Option in connection with the Global Offering, the estimated gross proceeds received by the Company from the Global Offering would be expected to be approximately $100 million, equivalent to approximately €87.8 million, before deducting underwriting commissions in respect of the Global Offering and estimated offering expenses payable by the Company.

The Company intends to use the net proceeds from the Global Offering 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 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, 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.

The Company’s estimates of the period of time through which its financial resources are expected to be adequate to meet its working capital requirements are forward-looking statements and involve risks and uncertainties, and actual results could vary materially and negatively as a result of a number of factors, as described under "Special Note Regarding Forward-Looking Statements."

Lock-up

In connection with the Global Offering, the Company’s executive board members and supervisory board members are subject to a contractual lock-up for a period of 90 days after the date hereof, subject to customary exceptions, including an exception for the purpose of financing the exercise price of stock options and/or satisfying any applicable taxes due in connection with such exercise. The Company has also agreed to be bound by a contractual lock-up for a period of 90 days after the date hereof, subject to customary exceptions.

Dilution

The transaction was supported by existing shareholders including Qatar Holding LLC and Invus, as well as other healthcare specialist investors.

On an indicative basis, assuming the full exercise of the Over-Allotment Option and of the PFW and, based on the number of outstanding Company’s shares and the Company’s shareholder structure as of 31 December 2025,, the Company’s shareholder structure would, to its knowledge, be as follows:

Shareholders

Before the Global Offering After the Global Offering excluding full exercise of the Over-Allotment Option After the Global Offering and full exercise of the Over-Allotment Option After the Global Offering and full exercise of the Over-Allotment Option and the PFW
Number of Shares % of share capital % voting rights Number of Shares % of share capital % voting rights Number of Shares % of share capital % voting rights Number of Shares % of share capital % voting rights
Invus (A) 5 844 592 12.07% 11.67% 6 095 038 12.05% 11.66% 6 095 038 12.04% 11.65% 6 440 137 12.63% 12.23%
JJDC (B) 5 623 816 11.62% 11.23% 5 623 816 11.12% 10.76% 5 623 816 11.11% 10.75% 5 623 816 11.03% 10.68%
Qatar Holding LLC (C) 4 298 507 8.88% 8.58% 4 526 185 8.95% 8.66% 4 526 185 8.94% 8.65% 4 526 185 888% 8.60%
Total (A) + (B) + (C° 15 766 915 32.57% 31.48% 16 245 039 32.11% 31.08% 16 245 039 32.09% 31.06% 16 590 138 32.55% 31.72%
Laurent Levy 1 394 292 2.88% 4.47% 1 394 292 2.76% 4.28% 1 394 292 2.75% 4.28% 1 394 292 2.74% 4.25%
Bart Van Rhijn 356 747 0.74% 0.71% 356 747 0.71% 0.68% 356 747 0.70% 0.68% 356 747 0.70% 0.68%
Anne-Juliette Hermant 241 708 0.50% 0.76% 241 708 0.48% 0.73% 241 708 0.48% 0.73% 241 708 0.47% 0.72%
Other managers and employees 253 585 0.52% 0.66% 253 585 0.50% 0.63% 253 585 0.50% 0.63% 253 585 0.50% 0.63%
Total Management & Employees 2 246 332 4.64% 6.66% 2 246 332 4.44% 6.33% 2 246 332 4.44% 6.32% 2 246 332 4.41% 6.32%
Free Float 30 374 703 62.74% 61.92% 32 081 241 63.41% 62.60% 32 115 046 63.43% 62.62% 32 165 152 63.00% 62.21%
Treasury Shares 22 118 0.05% 22 118 0.04% 22 118 0.04% 22 118 0.04%
TOTAL 48 410 068 100.00% 100.00% 50 594 730 100.00% 100.00% 50 628 535 100.00% 100.00% 51 023 740 100.00% 100.00%

On an indicative basis, the impact of the Global Offering on the shareholding of a shareholder holding 1% of the Company’s share capital prior to the Global Offering and not subscribing to it, and on the Company’s equity per share, is as follows (based on 48,410,068 Company’s shares outstanding and equity of €-84.483 million as of December 31, 2025):

Shareholding Equity per share
Non-diluted basis Diluted basis* Non-diluted basis Diluted basis*
Before the Global Offering 1.0000% 0.9066% -1.75 -1.58
After the Global Offering 0.9568% 0.8710% -1.67 -1.52
After the Global Offering (assuming the full exercise of the Over-Allotment Option) 0.9562% 0.8705% -1.67 -1.52
After the Global Offering (assuming the full exercise of the Over-Allotment Option and of the PFW) 0.9497% 0.8651% -1.66 -1.51

* including the 4,985,304 new ordinary shares issuable upon the exercise of founders’ warrants (BSPCE), warrants (BSA), and stock options (OSA) as of December 31, 2025.

Risk Factors

Potential investors should carefully consider the risks described under "Risk Factors" in the Preliminary Prospectus Supplement (as defined below), including the following risks:

shareholders not participating in the Global Offering may see their participation in the Company’s share capital diluted due to the issuance of new securities;
the volatility and liquidity of the Company’s Ordinary Shares and ADSs may experience significant fluctuation (mainly downwards), and there may be differences on Nasdaq and Euronext; and
sales of the Company’s Ordinary Shares and ADSs, in particular by its significant shareholders, could occur on the market and have an adverse impact on the Company’s trading prices.
Settlement and Delivery – Documentation

The Company’s ADSs are listed on the Nasdaq Global Select Market under the ticker symbol "NBTX". The Company’s Ordinary Shares are listed on Euronext under the symbol "NANO." The Company does not intend to list the PFW on any domestic or foreign securities exchange or nationally recognized trading system.

The Ordinary Shares are expected to be admitted to trading on Euronext on May 26, 2026.

Ordinary Shares (including those underlying ADS) issued in the Global Offering will be subject to an application for admission to trading on Euronext on the same trading line as the existing Ordinary Shares of the Company currently listed on Euronext, under the same ISIN code FR0011341205. The trading of Nanobiotix’s Ordinary Shares on Euronext is suspended today until the opening of trading of Nanobiotix’s ADSs on the Nasdaq Global Select Market at approximately 3:30 pm (Paris time) / 9:30 a.m. (New York time) today.

The ADSs and Ordinary Shares issued in the Global Offering are being 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 is being made only by means of a prospectus and prospectus supplement that form a part of the registration statement. A preliminary prospectus supplement relating to and describing the terms of the Global Offering (the "Preliminary Prospectus Supplement") has been filed with the SEC on May 20, 2026 and is available on the SEC’s website at www.sec.gov. The final prospectus supplement relating to the Global Offering will be filed with the SEC. When available, copies of the final prospectus supplement (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 21, 2026, View Source [SID1234665935])

AstraZeneca to showcase Phase III data in liver, breast and bladder cancers and potential first-in-class rare disease therapy at ASCO 2026

On May 21, 2026 AstraZeneca reported its ambition to eliminate cancer as a cause of death and transform outcomes for people living with rare diseases with new data across its diverse, industry-leading portfolio and pipeline at the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting, 29 May to 2 June 2026.

More than 85 abstracts will feature 10 approved and 13 potential new medicines from the Company, including 25 oral presentations. Highlights include:

EMERALD-3: Phase III trial of Imfinzi (durvalumab) in combination with Imjudo (tremelimumab), with or without lenvatinib, and transarterial chemoembolisation (TACE) in patients with unresectable hepatocellular carcinoma (HCC) eligible for embolisation (Oral Abstract #LBA4000).
CARES: Phase III clinical programme of anselamimab, a potential first-in-class anti-fibril therapy from Alexion, AstraZeneca Rare Disease, in newly diagnosed patients with light chain (AL) amyloidosis receiving standard of care for underlying plasma cell dyscrasia, including results from a prespecified subgroup analysis based on involved kappa (κ) or lambda (λ) free light chain (Oral Abstract #7501).
SERENA-6: Final progression-free survival 2 (PFS2) results and circulating tumour DNA (ctDNA) clearance data linked to longer-term efficacy outcomes from the SERENA-6 Phase III trial of camizestrant in combination with widely approved cyclin-dependent kinase (CDK) 4/6 inhibitors in the 1st-line treatment of patients with hormone receptor (HR)-positive, HER2-negative advanced breast cancer whose tumours have an emergent ESR1 mutation (Oral Abstract #LBA1007).
BLUESTAR: Updated safety and efficacy results from the BLUESTAR Ph I/IIa trial of the B7-H4-directed ADC puxitatug samrotecan (Puxi-Sam) in patients with relapsed/metastatic B7-H4-positive endometrial and ovarian cancer who progressed on prior standard-of-care therapy (Rapid Oral Abstract #5515). Puxi-Sam was recently granted Breakthrough Therapy Designation by the US Food and Drug Administration (FDA) in this setting.
PRIMAVERA: Safety and preliminary efficacy from the first-in-human Phase I PRIMAVERA trial of the protein arginine methyltransferase 5 (PRMT5) inhibitor AZD3470 as monotherapy in relapsed/refractory classic Hodgkin lymphoma (Oral Abstract #7003).
Phase I initial results for NT-175 T-cell receptor therapy in TP53 R175H-mutated unresectable, advanced and/or metastatic solid tumours including pancreatic adenocarcinoma (Oral Abstract #2506).
TROPION-Breast02: Additional efficacy endpoints from the TROPION-Breast02 Phase III trial of Datroway (datopotamab deruxtecan) as 1st-line treatment for patients with locally recurrent inoperable or metastatic triple-negative breast cancer (TNBC) who are not candidates for PD-1/PD-L1 inhibitors (Oral Abstract #1002).
DESTINY-Breast09: Exploratory analysis of treatment duration and clinical outcomes by complete response, partial response or stable/progressive disease in the DESTINY-Breast09 Phase III trial of Enhertu in combination with pertuzumab for the 1st-line treatment of patients with HER2-positive metastatic breast cancer (Rapid Oral Abstract #1021).
POTOMAC: Five-year overall survival and patient-reported outcomes from the Phase III POTOMAC trial of Imfinzi plus Bacillus Calmette-Guérin (BCG) induction and maintenance therapy in patients with high-risk non-muscle-invasive bladder cancer (Rapid Oral Abstract #4624).
Susan Galbraith, Executive Vice President, Oncology Haematology R&D, AstraZeneca, said: "The data at ASCO (Free ASCO Whitepaper) for our innovative medicines and next-wave assets further our strategy to redefine patient outcomes by taking novel combinations into earlier stages of disease and advancing new modalities. New data for Enhertu, Datroway and camizestrant reinforce their transformational potential in breast cancer. We’re also excited to share first clinical data for our T-cell receptor therapy, NT-175, and our PRMT5 inhibitor, AZD3470, as well as updated data for our most advanced in-house antibody drug conjugate, Puxi-Sam, which was recently granted Breakthrough Therapy Designation by the FDA. Collectively, these datasets underscore the strength and depth of our oncology pipeline."

Dave Fredrickson, Executive Vice President, Oncology Haematology Business Unit, AstraZeneca, said: "The EMERALD-3 data for Imfinzi and Imjudo in early liver cancer exemplify our successful strategy to move immunotherapy regimens into earlier stages of cancer where we can further improve outcomes for patients. With more than a dozen different indications approved across five cancer medicines in the last six months alone, we are reaching more patients with our growing portfolio, underscoring both the quality of our innovation and the strength of our business."

Gianluca Pirozzi, Head of Development, Regulatory and Safety, Alexion, said: "Results from the CARES Phase III clinical programme highlight the pioneering potential of anselamimab as a first-in-class, anti-fibril therapy for patients with kappa light chain amyloidosis. Its novel mechanism of action is designed to target and deplete amyloid deposits in affected organs, with potential to extend survival and reduce cardiovascular hospitalisations."

AstraZeneca is collaborating with Daiichi Sankyo to develop and commercialise Enhertu and Datroway.

Key AstraZeneca presentations during ASCO (Free ASCO Whitepaper) 20261

Lead Author

Abstract Title

Presentation details (CDT)

Antibody drug conjugates

Loi, S

Trastuzumab deruxtecan (T-DXd) + durvalumab (D) in patients (pts) with previously untreated HER2+ unresectable/metastatic breast cancer (mBC): Final analysis from DESTINY-Breast07.

Abstract #1012

Clinical Science Symposium

31 May 2026