On May 5, 2026 Alligator Bioscience (Nasdaq Stockholm: ATORX), a clinical-stage biotechnology company developing tumor-directed immuno-oncology antibody drugs, reported its interim results for the first quarter of 2026 and provided a business update.

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"During the first quarter of 2026, we continued to execute against our strategic priorities in a challenging biotech environment. We strengthened the clinical and translational foundation of mitazalimab through new data presentations, while maintaining clear focus on advancing the program toward late‑stage development under disciplined strategic and financial conditions. In parallel, HLX22 progress in our external portfolio, supports additional long‑term value potential without development cost exposure for Alligator."
Søren Bregenholt, CEO of Alligator Bioscience
BUSINESS UPDATE
Mitazalimab

Additional data dissemination: Updated and final outcomes data from the OPTIMIZE 1 study were presented at the ASCO (Free ASCO Whitepaper) Gastrointestinal Cancers Symposium 2026, further strengthening the clinical and translational foundation of the program.
Continued scientific visibility: New data from an investigator initiated trial evaluating mitazalimab were accepted for presentation at the AACR (Free AACR Whitepaper) Annual Meeting 2026, providing additional insight into the antibody’s mechanism of action and tumor directed immune activation.
Technology

Strengthened intellectual property position: Alligator strengthened the intellectual property protection for its bispecific antibody technology RUBY, reinforcing the scientific and commercial foundation for future pipeline development and partnering opportunities.
HLX22

Progress in partnered development: The first patient was dosed in Henlius’ Phase 2/3 study of HLX22 in recurrent breast cancer, marking an additional step in the late stage development of the program.
Company / Financial position

Capital structure updates following the rights issue: Alligator announced the outcome of the exercise of warrants of series TO 14, resulting in gross proceeds of approximately 19 MSEK and changes in the number of shares and votes, as well as related directed issues to guarantors and Fenja Capital, in accordance with previously communicated terms. Alligator’s management further announced their intention to subscribe pro rata in the TO 14 warrant program, aligning management interests with those of shareholders.
Nomination Committee proposal ahead of the AGM: The Nomination Committee presented its proposal for the Board of Directors ahead of the Annual General Meeting, including the nomination of two new Board members.
FINANCIAL SUMMARY FOR Q1 2026
The financial summaries for the quarterly periods ending 31 March 2026 and 31 March 2025 are presented below.

All amounts in MSEK,
unless specified January – March 2026 January – March 2025
Net sales - -
Operating profit/loss -17.8 -43.7
Profit/loss for the period 1.4 -8.3
Cash flow for the period -29.1 -34.6
Cash and cash equivalents 33.0 28.9
Earnings per share before and after dilution*, SEK 0.0 -1.1
* Adjusted for reverse share split in 2025.
The full report is attached as a PDF, and is also available on the company’s website: View Source

Alligator will host a webinar on Tuesday, 5 May 2026, at 1 p.m. CEST/ 7 a.m. EDT for investors, analysts and media, where CEO Søren Bregenholt and CFO Johan Giléus will present and comment on the interim report, which will be followed by a Q&A session.

(Press release, Alligator Bioscience, MAY 5, 2026, View Source [SID1234665102])

On May 5, 2026 Cytospire Therapeutics (‘Cytospire’), a UK based biotech developing differentiated multispecific immune cell engager antibodies designed to enhance and direct the activity of the body’s own immune system, reported the closing of an oversubscribed £61 million ($83 million) Series A financing supported by a strong syndicate of new and existing biotech investors.

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Cytospire will use the proceeds to advance its pipeline of first-in-class pan-gamma delta T cell engagers, including its lead programme, CYT X300, which is currently being advanced through IND-enabling preclinical studies and GMP manufacturing. A first-in-human clinical study is being planned to evaluate CYT X300 as a treatment for EGFR-positive solid tumours, such as colorectal, head and neck and non-small cell lung cancers.

The round was led by 4BIO Capital, with significant investment from new syndicate members Servier Ventures, British Business Bank, Sound Bioventures and Criteria Bio Ventures, as well as from existing investors Abingworth and LifeArc Ventures. Modi Ventures, Medical Incubator Japan and Pathway Bioventures also join the round as new investors. It is the first investment from Servier Ventures, the newly established corporate venture fund of Servier, which aims to advance science and unlock tomorrow’s breakthrough therapies for the benefit of patients.

"We are excited to write the next chapter of Cytospire’s story with this fantastic group of specialist investors," said Natalie Mount, Chief Executive Officer of Cytospire Therapeutics. "Immune cell engagers are an important type of cancer immunotherapy, but we know that there are significant limitations from both an efficacy and safety perspective with conventional CD3 T cell engagers. We are building on the growing body of translational and clinical data showing gamma delta T cells are critical components of the anti-cancer immune response, with biology ideally suited to novel cell engagers. The significant fundraise that we are announcing today reflects the quality of our team and our science, and the huge potential of our pan-gamma delta T cell engagers".

Cytospire’s pan-gamma delta T cell engagers are uniquely engineered to target all gamma delta T cells rather than specific subtypes. Through this approach, Cytospire seeks to overcome patient heterogeneity and generate broader, more effective anti‑tumour immune responses through the activation of both tissue/tumour resident and blood resident effector cells.

"Cancer immunotherapy has provided a step-change in treatment for many types of cancer over the past decade, but we need to do more," commented Owen Smith, Partner at 4BIO Capital and Board Member at Cytospire. "We are proud to have led the Series A alongside this strong investor syndicate. It is exciting to see the company advance CYT X300 and its pioneering portfolio of cancer therapies into the clinic to improve outcomes for cancer patients."

"As the founding investor in Cytospire, we are strong believers in the potential of gamma delta T cell-based therapies to change the treatment paradigm in multiple cancer indications" added Bali Muralidhar, Global Head of Life Sciences and Chief Investment Officer at Abingworth and Board Member at Cytospire. "There is a need for novel strategies in the field of immune cell engagers, and we believe that Cytospire is well positioned at the forefront of this exciting space".

In connection with the financing, Cytospire’s Board of Directors has been strengthened by the appointments of Alexis Vandier (Global Head of Servier Ventures), Carmine Circelli (Investment Director, British Business Bank), and Anna Gran (Principal, Sound Bioventures).

(Press release, Cytospire Therapeutics, MAY 5, 2026, View Source [SID1234665077])

On May 4, 2026 NANOBIOTIX (Euronext: NANO –– NASDAQ: NBTX – the ‘‘Company’’), a late-stage clinical biotechnology company pioneering physics-based approaches to expand treatment possibilities for patients with cancer and other major diseases, reported FDA acceptance of a protocol amendment to the ongoing pivotal NANORAY-312 study.

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This protocol amendment, submitted by NANORAY-312 global sponsor Johnson & Johnson, eliminates the previously planned interim analysis and modifies the final analysis to include fewer events than originally planned and to be conducted sooner.

In Nanobiotix’s view, this decision could accelerate and expand the global registration pathway for JNJ-1900 (NBTXR3) in head and neck cancer, providing the opportunity for earlier increased revenue generation for the Company.

Nanobiotix anticipates that the modified final analysis should readout in the same timeframe as the previously planned interim analysis. Exact timing will depend on when clinical events occur.

Per the license agreement, Nanobiotix is eligible to receive hundreds of millions in aggregate payments in the next few years, subject to the achievement of remaining development and regulatory milestone events related to the first two programs evaluating JNJ-1900 (NBTXR3) in head and neck cancer and lung cancer.

About JNJ-1900 (NBTXR3)

JNJ-1900 (NBTXR3) is a novel, potentially first-in-class oncology product composed of functionalized hafnium oxide nanoparticles that is administered via one-time intratumoral injection and activated by radiotherapy. Its proof-of-concept was achieved in soft tissue sarcomas through a successful randomized Phase 2/3 study in 2018. The product candidate’s mechanism of action (MoA) is designed to induce significant tumor cell death in the injected tumor when activated by radiotherapy, subsequently triggering adaptive immune response and long-term anti-cancer memory. Given the physical MoA, Nanobiotix believes that JNJ-1900 (NBTXR3) could be scalable across any solid tumor that can be treated with radiotherapy and across any therapeutic combination, particularly immune checkpoint inhibitors.

Radiotherapy-activated JNJ-1900 (NBTXR3) is being evaluated across multiple solid tumor indications as a single agent or combination therapy. The program is led by NANORAY-312—a global, randomized Phase 3 study in locally advanced head and neck squamous cell cancers. In February 2020, the United States Food and Drug Administration granted regulatory Fast Track designation for the investigation of JNJ-1900 (NBTXR3) activated by radiation therapy, with or without cetuximab, for the treatment of patients with locally advanced HNSCC who are not eligible for platinum-based chemotherapy—the same population being evaluated in the Phase 3 study.

Given the Company’s focus areas, and balanced against the scalable potential of NBTXR3, Nanobiotix has engaged in a collaboration strategy to expand development of the product candidate in parallel with its priority development pathways. Pursuant to this strategy, in 2019 Nanobiotix entered into a broad, comprehensive clinical research collaboration with The University of Texas MD Anderson Cancer Center to sponsor several Phase 1 and Phase 2 studies evaluating JNJ-1900 (NBTXR3) across tumor types and therapeutic combinations. In 2023, Nanobiotix announced a license agreement for the global co-development and commercialization of JNJ-1900 (NBTXR3) with Janssen Pharmaceutica NV, a Johnson & Johnson company.

(Press release, Nanobiotix, MAY 4, 2026, https://www.globenewswire.com/news-release/2026/05/04/3287230/0/en/nanobiotix-announces-protocol-amendment-to-ongoing-global-phase-3-head-and-neck-cancer-study.html [SID1234665076])

On May 4, 2026 Telix Pharmaceuticals Limited (ASX: TLX, NASDAQ: TLX, "Telix") reported the publication of a new independent analysis of Phase 3 ZIRCON trial data in European Urology, demonstrating that TLX250-Px (Zircaix2, 89Zr-girentuximab) PET/CT3 imaging may be highly predictive of renal malignancy across all subtypes, not limited to clear cell renal cell carcinoma (ccRCC).

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Recognizing that carbonic anhydrase IX (CAIX) expression is also observed in other renal cancer subtypes4, this subsequent analysis conducted by international investigators who participated in ZIRCON Phase 3 trial5, evaluated centrally reviewed imaging and pathology data to explore whether tracer uptake in renal masses correlated with malignancy beyond ccRCC.

The analysis demonstrated that positive PET findings were highly predictive of malignancy overall, including in non-clear cell renal cell carcinoma (nccRCC), with a reported positive predictive value (PPV) of 98% (95% CI, 96–99), sensitivity of 82% (95% CI, 82–90), and specificity of 87% (95% CI, 81–93). These exploratory scientific findings suggest TLX250-Px has applications beyond the detection of ccRCC in primary renal masses and may have implications to management of nccRCC.

Aboubacar Kaba, MD, urologist at the University of California, Los Angeles and corresponding author, commented: "This analysis shows that when TLX250-Px PET/CT is positive, it is highly predictive of renal malignancy, including beyond ccRCC. Thus, the utility of this test may be important in distinguishing more hypoxic, and therefore, aggressive disease from indolent tumors with clear treatment implications. This may provide an additional tool to aid in risk stratifying or guiding patient and clinician decisions in the treatment of renal masses."

Dr. David N. Cade, Group Chief Medical Officer at Telix, added: "Publication of these data in European Urology reflects the scientific strength of the ZIRCON trial and the robustness of its central imaging and pathology review. While ZIRCON was designed to address ccRCC, this analysis supports continued evaluation of TLX250-Px PET imaging across a broader spectrum of renal malignancies, with potential application in the management of patients with non-clear cell RCC. Furthermore, essentially all false-positives for ccRCC in the ZIRCON study have now been shown to be other malignant kidney cancer subtypes, reducing the risk of overtreatment and further supporting clinical adoption."

The full paper is available at: View Source(26)02037-3/fulltext.

These findings are based on exploratory analyses and were not the basis of Telix’s Biologics License Application (BLA) submission for TLX250-Px, which focuses exclusively on detection of ccRCC in primary renal masses.

About TLX250-Px

TLX250-Px is a PET imaging candidate under development for the diagnosis and characterization of ccRCC, and included in leading international guidelines for renal imaging6. It works by specifically binding to carbonic anhydrase IX (CAIX), a validated target protein expressed on >95% of ccRCC cells7, to produce images with high tumor-to-background ratio and high intra- and inter-reader consistency.

Telix’s pivotal Phase 3 ZIRCON trial evaluating TLX250-Px in 300 patients, of whom 284 were evaluable, met all primary and secondary endpoints, including showing 86% sensitivity and 87% specificity and a 93% positive predictive value (PPV) for ccRCC across three independent radiology readers8. Telix believes this demonstrated the ability of TLX250-Px to reliably detect the clear cell phenotype and provide an accurate, non-invasive method for diagnosing and characterizing ccRCC.

ZIRCON-X, a noninterventional, prospective, post hoc study using imaging data from ZIRCON, found that almost half of all patients (48.6%) would have undergone a change in clinical management if imaged with TLX250-Px, compared with baseline standard-of-care (SOC) imaging, and that more than 20% could potentially have avoided an invasive biopsy9.

For more on TLX250-Px and Telix’s theranostic kidney cancer program, click here.

TLX250-Px has not received a marketing authorization in any jurisdiction.

(Press release, Telix Pharmaceuticals, MAY 4, 2026, View Source [SID1234665075])

On May 4, 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, reported the initiation of a Phase 1b clinical trial of AKY-25191 in patients with metastatic castration-resistant prostate cancer (mCRPC). The mCRPC-dedicated Phase 1b trial is part of Aktis’ clinical development strategy to develop AKY-2519 broadly in B7-H3 expressing tumors. Aktis plans to initiate a Phase 1b basket trial in lung, colorectal, and other high B7-H3 expressing solid tumors in the second half of 2026.

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"We see an opportunity to advance broad clinical development of AKY-2519 given the high expression of B7-H3 across multiple solid tumor types and associated poor prognosis. We are excited to advance a two-trial strategy, which enables us to evaluate AKY-2519 broadly in multiple patient subsets and to efficiently generate indication-relevant data for actionable, data-driven decision-making," said Akos Czibere, MD, PhD, Chief Medical Officer at Aktis. "This strategy was informed by insights from our clinical advisory boards and reflects the distinct treatment patterns and clinical needs of patients with mCRPC compared to other solid tumor patients. Importantly, this allows us to generate data in mCRPC in both PLUVICTO-naïve and -experienced patients to maximize the potential impact of AKY-2519."

"Prostate cancer is one of the most important indications for therapeutic radiopharmaceuticals; however, many unmet needs persist," said Oliver Sartor, MD, LCMC Health, Director, Transformational Prostate Cancer Research Center, New Orleans, LA. "A substantial number of mCRPC patients are ineligible for PSMA-targeted therapy due to low target expression and even more importantly, many patients have a sub-optimal response to PSMA targeted therapy. We all agree that further improvements are needed. Given high expression in mCRPC, B7-H3 represents a promising new target. The Phase 1b mCRPC AKY-2519 clinical study is a critical step in learning more about the safety and efficacy of a promising new next-generation B7-H3 targeted radiopharmaceutical. We look forward to learning more from these investigations."

The first Phase 1b open label trial will enroll patients with mCRPC, including both PLUVICTO-naïve and PLUVICTO-experienced cohorts, at multiple prostate-specific radioligand therapy centers in the U.S. The study will explore three dose levels in each cohort. Following dose escalation, the trial will expand enrollment at selected dose levels to generate additional clinical data. Preliminary data are expected in 2027. The second Phase 1b multi-center, open label trial will enroll patients in the U.S. with lung, colorectal, and other high B7-H3 expressing solid tumors. The protocol for this basket trial has been finalized and is currently under regulatory review.

AKY-2519 is the second miniprotein Aktis has advanced to the clinic in the past 12 months. Aktis’ lead program, AKY-1189, a miniprotein radioconjugate protein targeting Nectin-4 expressing tumors, is currently enrolling patients in an ongoing Phase 1b trial, with preliminary data anticipated in the first quarter of 2027.

Conference Call and Webcast Information
Aktis will host a live conference call and webcast tomorrow, Tuesday, May 5, 2026, at 8 a.m. ET to discuss its clinical development strategy for AKY-2519. 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 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.

PLUVICTO (lutetium Lu 177 vipivotide tetraxetan) is a registered trademark of Novartis Pharmaceuticals Corporation.

About Aktis’ miniprotein radioconjugate platform
Aktis has developed a proprietary, isotope-agnostic miniprotein radioconjugate platform to selectively deliver the tumor-killing properties of radioisotopes to targeted tumors. Aktis’ therapeutic miniprotein radioconjugates are designed to maximize anti-cancer activity through high tumor penetration coupled with internalization and retention in cancer cells, while rapidly clearing from normal organs and tissues. The Aktis platform further enables clinicians to visualize and verify target engagement with imaging isotopes prior to exposure to therapeutic radioisotopes. Leveraging this platform, and its patient-first end-to-end supply chain, Aktis is advancing a pipeline of next-generation targeted radiopharmaceuticals to address the unmet needs of patients across a broad spectrum of solid tumors.

(Press release, Aktis Oncology, MAY 4, 2026, View Source [SID1234665074])