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.

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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.

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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

09:18

Cescon, DW

First-line datopotamab deruxtecan (Dato-DXd) vs chemotherapy in patients with locally recurrent inoperable or metastatic triple-negative breast cancer (TNBC) for who immunotherapy was not an option: Additional efficacy endpoints from the TROPION-Breast02 study.

Abstract #1002

Oral Abstract Session

2 June 2026

10:09

Mileshkin, LR

Updated safety and efficacy of puxitatug samrotecan (Puxi-Sam, AZD8205) in patients (pts) with endometrial cancer (EC) or ovarian cancer (OC): Phase 1/2a BLUESTAR study.

Abstract #5515

Rapid Oral Abstract Session

30 May 2026

09:00

Park, YH

A DESTINY-Breast09 analysis of treatment duration and clinical outcomes by best response to trastuzumab deruxtecan (T-DXd) + pertuzumab (P).

Abstract #1021

Rapid Oral Abstract Session

31 May 2026

12:42

Untch, M

Secondary safety analysis of trastuzumab deruxtecan (T-DXd) vs trastuzumab emtansine (T-DM1) in DESTINY-Breast05: Clinical and demographic risk factors of interstitial lung disease (ILD) and radiation pneumonitis (RP).

Abstract #516

Rapid Oral Abstract Session

1 June 2026

10:57

Shitara, K

Sonesitatug vedotin (Sone-Ve) monotherapy in patients (pts) with claudin 18.2–positive (CLDN18.2+) advanced or metastatic gastric or gastroesophageal junction (GEJ) cancers: Data from CLARITY-PanTumor01.

Abstract #4023

Poster Session

30 May 2026

09:00

Janjigian, Y

First-line (1L) trastuzumab deruxtecan (T-DXd)–based regimens in advanced HER2-expressing gastric cancer (GC), gastroesophageal junction adenocarcinoma (GEJA), or esophageal adenocarcinoma (EA): Safety results from DESTINY-Gastric03 (DG-03) Part 2 arms D and F, and Part 4.

Abstract #4022

Poster Session

30 May 2026

09:00

Zhang, Y

Trastuzumab deruxtecan (T-DXd) for pretreated patients in China with HER2 IHC 3+ solid tumors: DESTINY-PanTumor03 Part 1 primary analysis.

Abstract #3026

Poster Session

30 May 2026

13:30

Immuno-oncology

Abou-Alfa, GK

Efficacy and safety results from EMERALD-3: A phase 3, randomized study of tremelimumab plus durvalumab with or without lenvatinib combined with transarterial chemoembolization (TACE) in participants (pts) with unresectable embolization-eligible hepatocellular carcinoma (eeHCC).

Abstract #LBA4000

Oral Abstract Session

1 June 2026

09:45

Skoulidis, F

Tremelimumab (T) + durvalumab (D) + chemotherapy (CT) vs pembrolizumab (P) + CT in 1L non-squamous (NSQ) metastatic NSCLC (mNSCLC) with STK11, KEAP1, and/or KRAS mutations (mut): Interim analysis (IA) of the phase 2b TRITON study.

Abstract #8515

Rapid Oral Abstract Session

30 May 2026

13:45

Heymach, JV

Impact of neoadjuvant durvalumab (D) on tumor microenvironment (TME) features and their association with event-free survival (EFS) in patients with resectable NSCLC (R-NSCLC) from the phase 3 AEGEAN trial.

Abstract #8015

Rapid Oral Abstract Session

31 May 2026

17:30

De Santis, M

Durvalumab (D) in combination with BCG induction and maintenance (I + M) therapy for BCG-naive, high-risk non–muscle-invasive bladder cancer (NMIBC): 5-year overall survival (OS) analysis and patient-reported outcomes (PROs) from POTOMAC.

Abstract #4624

Rapid Oral Abstract Session

1 June 2026

08:12

IO Bispecifics

O’Sullivan, CC

Neoadjuvant rilvegostomig (R) + trastuzumab deruxtecan (T-DXd) in high-risk HER2-negative breast cancer: Results from the I-SPY 2.2 trial.

Abstract #LBA514

Rapid Oral Abstract Session

1 June 2026

10:45

Zhou, J

First-line rilvegostomig (R) + chemotherapy (CTx) in advanced biliary tract cancer (BTC): Updated analysis of GEMINI-Hepatobiliary substudy 2 cohort A.

Abstract #88

Poster Session

30 May 2026

09:00

Guo, Y

Volrustomig monotherapy for recurrent/metastatic HNSCC: Substudy 2 of the eVOLVE-02 phase 2 study.

Abstract #482

Poster Session

30 May 2026

13:30

Tumour drivers and resistance

Wang, Z

Osimertinib with/without chemotherapy in patients with persistent ctDNA EGFR mutant (EGFRm) NSCLC at 3 weeks after 1L osimertinib: A randomized phase II study (FLAME study).

Abstract #LBA101

Clinical Science Symposium

30 May 2026

08:40

Bidard, FC

First-line (1L) camizestrant (CAMI) for emergent ESR1 mutations (ESR1m) in advanced breast cancer (ABC): Final progression-free survival 2 (PFS2) from the phase III SERENA-6 trial.

Abstract #LBA1007

Oral Abstract Session

2 June 2026

11:57

Peng, Z

A phase 2 pivotal study of savolitinib in patients with MET-amplified gastric cancer or gastroesophageal junction adenocarcinomas.

Abstract #4011

Rapid Oral Abstract Session

1 June 2026

13:27

Cell Therapy

Surana, R

Initial phase 1 study results of NT-175 engineered T-cell therapy in TP53 R175H–mutated unresectable advanced solid tumors.

Abstract #2506

Oral Abstract Session

31 May 2026

10:00

Epigenetics

Derenzini, E

A phase 1 study of the PRMT5 inhibitor AZD3470 in patients with relapsed/refractory classic Hodgkin lymphoma (PRIMAVERA).

Abstract #7003

Oral Abstract Session

30 May 2026

16:00

Rare Disease

Wechalekar, AD

Phase 3 randomized trial to evaluate the impact of anselamimab on all-cause mortality in κ light chain amyloidosis.

Abstract #7501

Oral Abstract Session

29 May 2026

14:57

Chen, AP

Final analysis of KOMET (NCT04924608), a phase 3 study of selumetinib in adults with NF1-PN.

Abstract #3110

Poster Session

30 May 2026

13:30

More than 85 abstracts at ASCO (Free ASCO Whitepaper) 2026 will feature AstraZeneca medicines and pipeline molecules

(Press release, AstraZeneca, MAY 21, 2026, View Source [SID1234665951])

Fulgent Announces Rapid Oral Full Abstract Publication for FID-007 Within the Head and Neck Cancer Track Session at the ASCO 2026 Annual Meeting

On May 21, 2026 Fulgent Genetics, Inc. (NASDAQ: FLGT) ("Fulgent" or the "Company"), a technology-based company with a well-established laboratory services business and a therapeutic development business, reported that its full abstract has been released on the ASCO (Free ASCO Whitepaper) 2026 website. The abstract will be presented within the Head and Neck Cancer Track of the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Rapid Oral Abstract Session on June 1, 2026, from 4:30pm to 6:00pm (CDT) in Hall D1 of McCormick Place, Chicago.

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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!

The abstract is entitled "FID-007 in combination with cetuximab in recurrent or metastatic (R/M) head and neck squamous cell carcinoma (HNSCC), Abstract #6020". It presents interim data from the Company’s open-label, randomized Phase 2 study (NCT06332092). The study was designed to evaluate the efficacy of two different dosing regimens and to characterize the pharmacokinetics (PK) and safety and tolerability of FID-007 in combination with cetuximab in patients with disease progression after treatment with PD-1-based immune checkpoint inhibitor. As of the data cut-off date of December 20, 2025, FID-007 exhibited meaningful clinical activity and a favorable safety profile when combined with cetuximab in target patient population.

Key observations in the abstract include:

FID-007 combined with cetuximab demonstrated anticancer activity at both dose levels for the 1L–2L treatment of R/M HNSCC. Of the 42 patients evaluable for efficacy, the objective response rate (ORR) was 60% (58% in Arm A, 61% in Arm B), and the median progression-free survival (mPFS) was 7.2 mo [6.7 mo in Arm A (95% CI: 2.0-12.8), and 7.2 mo in Arm B (95% CI: 4.0-NR)]. The median duration of response (DoR) was 7.4 mo (7.4 mo in Arm A, NR in Arm B) with 56% (14/25) of responders continuing to respond at the time of data cut-off. The overall survival data (OS) are immature at present.
FID-007 exhibited a favorable safety and tolerability profile consisting mostly of grade 1-2 treatment-related adverse events (TRAEs). Grade 3-4 TRAEs occurring in ≥ 2 patients included neutropenia (3 in Arm A, 5 in Arm B), anemia (2 in Arm A, 4 in Arm B), leukopenia (3 in Arm B), acneiform dermatitis (2 in Arm A), maculo-papular rash and other rash (2 in Arm B). There was 1 Grade 5 TRAE (pneumonia in Arm B).
The full abstract is now available on the ASCO (Free ASCO Whitepaper) website, as well as on Fulgent’s investor relations website.

The final presentation slides with updated data will be available on Fulgent’s investor relations website at the start of the session on June 1, 2026.

Dr. Ray Yin, Co-Founder and President of Fulgent Pharma, said, "Based on available estimates, there are approximately 73,000 new head and neck Squamous Cell Carcinoma (HNSCC) cases in the U.S. and 930,000 worldwide each year, with 50% to 60% progressing to the recurrent or metastatic stage. We are encouraged by the clinical progress achieved so far and believe in the potential of FID-007 to serve as a meaningful treatment for R/M HNSCC patients, particularly given that the current standard of care offers a historical objective response rate (ORR) of just 5.8% to 19.1% and a progression-free survival (PFS) of only 2.3 to 3.7 months."

(Press release, Fulgent Genetics, MAY 21, 2026, View Source [SID1234665967])

Autolus Therapeutics to Present Clinical Data Update at the American Society of Clinical Oncology Annual Meeting 2026

On May 21, 2026 Autolus Therapeutics plc (Nasdaq: AUTL), a commercial-stage biopharmaceutical company developing, manufacturing and delivering next-generation programmed T cell therapies and candidates, reported the online publication of an abstract submitted to the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting, to be held May 29 – June 2, 2026, in Chicago, Illinois.

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"Data to be presented at the upcoming ASCO (Free ASCO Whitepaper) Annual Meeting provides insight into the use of obe-cel in patients with B-ALL and extramedullary disease (EMD), which is typically associated with shorter median and long-term survival compared to marrow-only relapse. With an overall response rate of 59% and a median duration of response (mDOR) of 42.6 months for patients with EMD, obe-cel may be considered as a potential treatment option for this difficult to treat population of patients," said Matthias Will, MD, Autolus Chief Development Officer.

Abstract 6517
Title: The effect of obecabtagene autoleucel (obe-cel) on adult patients (pts) with relapsed/refractory B-cell acute lymphoblastic leukemia (R/R B-ALL) and extramedullary disease (EMD).
Session Type and Track: Rapid Oral Abstract: Hematologic Malignancies—Leukemia, Myelodysplastic Syndromes, and Allotransplant.
Session Date and Time: May 30, 2026; 1:15 – 2:45PM CDT
Session Room: E450a
Abstract Number: 6517
Presentation time: 2:27 – 2:33pm CDT
Presenting Author: Jae Park, MD, Director, Adult ALL Program | Acting Chief, Cellular Therapeutics, Memorial Sloan Kettering Cancer Center, New York, NY, USA

Summary: A post-hoc analysis of the Phase Ib/II FELIX study (NCT04404660) was conducted, evaluating the efficacy and safety of obe-cel in patients with relapsed or refractory (r/r) B-ALL, by EMD status at lymphodepletion (LD). Following LD, adults with r/r B-ALL received obe-cel using a tumor burden-guided dosing strategy to minimize toxicity. Obe-cel treatment demonstrated favorable response and safety outcomes in patients with and without EMD in the FELIX trial. Of 127 obe-cel infused patients, 27 (21%) had EMD at LD. Among responders, duration of response in patients with EMD was 42.6 months, and the overall remission rate was 59%. Overall, these findings suggest a positive benefit–risk profile for obe-cel, including for patients with adverse risk features, specifically EMD at LD.

(Press release, Autolus, MAY 21, 2026, View Source [SID1234665983])

Black Diamond Therapeutics Announces Positive Phase 2 Results for Silevertinib in Frontline NSCLC Patients with EGFR Non-Classical Mutations

On May 21, 2026 Black Diamond Therapeutics, Inc. (Nasdaq: BDTX), a clinical-stage oncology company developing MasterKey therapies that target families of oncogenic mutations in patients with cancer, reported positive results from its Phase 2 trial of silevertinib in frontline (1L) non-small cell lung cancer (NSCLC) patients with epidermal growth factor receptor (EGFR) non-classical mutations (NCMs). These data will be presented by Julia Rotow, M.D., Clinical Director, Lowe Center for Thoracic Oncology at the Dana-Farber Cancer Institute, at the 2026 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting on Saturday, May 30, 2026, 1:15 PM-2:45 PM CDT.

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"Silevertinib continues to demonstrate potential to become a practice changing frontline therapy for NSCLC patients with EGFR-NCMs, delivering robust preliminary mPFS that far exceeds historical data for currently available therapies" said Sergey Yurasov, M.D., Ph.D., Chief Medical Officer of Black Diamond Therapeutics. "Importantly, silevertinib prevented the development of de novo brain metastases in this patient population, where progression via CNS metastases frequently occurs. We look forward to meeting with the FDA later this year to discuss our pivotal development plan."

"Patients with EGFR non-classical mutations represent a meaningful and underserved subset of NSCLC, with historically poor progression-free survival on available frontline TKIs," added Dr. Rotow. "The activity we are seeing with silevertinib across the full NCM spectrum, combined with its CNS activity, is highly encouraging, and I look forward to sharing these data with the oncology community at ASCO (Free ASCO Whitepaper) next week."

Silevertinib 1L NSCLC Phase 2 Results Summary

Results as of an April 11, 2026 data cutoff date include:

43 patients with 1L NSCLC were enrolled at a 200 mg once daily dose of silevertinib
Patients presented with a broad spectrum of EGFR-NCMs, including compound and P-Loop and C-Helix Compressing (PACC) mutations
19 patients with brain metastases, 7 of whom had measurable central nervous system (CNS) target lesions
11.2 months median follow-up

Durability
Preliminary median Progression-free Survival (mPFS) is 15.2 months (95% CI: 10.8; NE)
Median duration of response (DOR) had not been reached (95%CI: 7.0, NE)
23 of 43 patients (53%) remain on therapy, with longest at 23.5 months

CNS Activity
No patients developed de novo brain metastases
Previously disclosed CNS Objective Response Rate (ORR by RANO-BM) remained at 86%

ORR and DCR
Previously disclosed Objective Response Rate (ORR by RECIST 1.1) and Disease Control Rate (DCR) remained at 60% and 91%, respectively
Variant allele frequency (VAF) reduction observed in all evaluable patients across 25 unique EGFR-NCMs, including PACC

Safety
No new safety signals were observed
The rate of TRAEs > Grade 3 was reduced to 28% following dose reduction
Patients maintained or deepened clinical responses after dose reduction
Safety and efficacy data support 150 mg QD for pivotal development

ASCO Abstract: 8519
Title: Safety and efficacy results of the phase 2 study of silevertinib (BDTX-1535) in treatment-naïve patients with non-small cell lung cancer with non-classical EGFR mutations
Presenter: Julia Rotow, M.D., Clinical Director, Lowe Center for Thoracic Oncology at Dana-Farber Cancer Institute
Date and Time: May 30, 2026, 1:15 PM-2:45 PM CDT (slides will be available at the time of the presentation on the Black Diamond website)

Company Webcast Information
Black Diamond will hold a webcast for investors on Thursday, May 21, 2026 at 5:30 p.m. EDT. The webcast can be accessed under "Events and Presentations" on the Investors section of the Black Diamond website at www.blackdiamondtherapeutics.com.

About Silevertinib

Silevertinib is an investigational oral, covalent, brain-penetrant fourth-generation tyrosine kinase inhibitor (TKI) that selectively targets classical and more than 50 non-classical EGFR mutations in NSCLC. It is also designed to potently inhibit key EGFR alterations seen in GBM, including EGFRvIII, while avoiding the paradoxical EGFR activation reported with reversible TKIs. To date, over 200 patients with EGFR‑mutant NSCLC or EGFR‑altered GBM have been treated with silevertinib.

In addition to the ongoing Phase 2 trial of silevertinib in patients with EGFRm NSCLC, the Company also initiated a randomized Phase 2 trial of silevertinib in patients with newly diagnosed EGFRvIII-positive GBM (NCT07326566) in May 2026.

(Press release, Black Diamond Therapeutics, MAY 21, 2026, View Source [SID1234665920])