Radiopharm Theranostics Receives Positive Recommendation from Data Safety and Monitoring Committee to Advance to Cohort 4 in 177Lu-RAD202 Phase 1 HEAT Clinical Trial

On August 20, 2026 Radiopharm Theranostics (ASX: RAD, Nasdaq: RADX, "Radiopharm" or the "Company"), a clinical-stage biopharmaceutical company focused on developing innovative oncology radiopharmaceuticals for areas of high unmet medical need, reported that it has received a positive recommendation from the Data Safety and Monitoring Committee (DSMC) to advance its clinical-stage radiotherapeutic asset, 177Lu-RAD202 (RAD202), to the next dose level of 180mCi in the Phase 1 ‘HEAT’ clinical trial in patients with Human Epidermal Growth Factor Receptor 2 (HER2)-positive advanced solid tumors1. The DSMC is a multidisciplinary committee that conducts detailed reviews of study data, discusses potential safety events and provides recommendations regarding trial continuation.

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"Advancing RAD202 into Cohort 4 marks a significant step forward in the development of one of our most promising therapeutic candidates," said Riccardo Canevari, CEO and Managing Director of Radiopharm Theranostics. "The DSMC’s recommendation supports the favorable safety profile observed to date and allows us to continue evaluating higher dose levels in patients with HER2-positive advanced solid tumors. As we execute on our clinical development strategy, we remain focused on unlocking the full potential of RAD202 and generating meaningful data that could support a differentiated radiotherapeutic option for HER2-positive patients in need of new treatment alternatives."

The Phase 1 ‘HEAT’ study is currently being conducted at clinical centers across Australia. The announcement of the previous dose level in this study of 130mCi was released on 8 April 2026.

About 177Lu-RAD202:

RAD202 is a proprietary single-domain monoclonal antibody (sdAb) that targets the Human Epidermal Growth Factor Receptor 2 (HER2)-positive expression in advanced solid tumors. HER2 is overexpressed in breast cancer and several other solid tumors and represents a validated target in oncology. In a previous diagnostic study of ten HER2-positive breast cancer patients, RAD202 demonstrated clinical proof-of-concept and had positive safety and biodistribution.

(Press release, Radiopharm Theranostics, AUG 20, 2026, View Source [SID1234670267])

NovaBridge Reports First Half 2026 Financial Results and Highlights Pipeline Momentum and Strategic Execution

On August 20, 2026 NovaBridge Biosciences (Nasdaq: NBP) ("NovaBridge" or the "Company"), a global biotechnology company that identifies differentiated innovation and applies disciplined development, financing, and partnering strategies to create value, reported financial results for the six months ended June 30, 2026, and provided a business update. During the first half of 2026, the Company continued executing its strategic priorities by progressing key clinical milestones for its lead programs. The Company also strengthened leadership, governance, and capital allocation to support long-term value creation.

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"Significant innovation exists across geographies and organizations, yet many promising therapies never reach their full potential," said Srishti Gupta, MD, MPP, Chief Executive Officer of NovaBridge. "NovaBridge was built to identify those opportunities, advance them efficiently and create value through the path best suited to each asset. The progress of givastomig and VIS-101 reflects our ability to both identify differentiated science and to achieve meaningful development milestones, positioning NovaBridge to continue creating value for patients and shareholders."

"NovaBridge is building the capabilities required to succeed over the long term. The progress of givastomig and VIS-101, together with the continued strengthening of the organization, reflects deliberate execution against that objective," said Fu Wei, Chairman of the Board of NovaBridge.

Pipeline Overview and Potential Upcoming Milestones

NovaBridge’s two lead programs illustrate the complementary capabilities at the core of its strategy. Givastomig, a potential first-in-class Claudin 18.2-Targeted Immuno Amplifier ("CTIA"), reflects NovaBridge’s ability to efficiently execute differentiated science toward registrational development. VIS-101, a purpose-designed tetravalent VEGF-A × ANG-2 peptibody for retinal vascular diseases, developed through NovaBridge’s majority-owned subsidiary leading its ophthalmology platform, Visara, Inc. ("Visara"), reflects NovaBridge’s ability to identify and acquire differentiated therapeutic assets that others have overlooked.

Givastomig

Givastomig is a potential first-in-class CTIA. It is a bispecific Claudin 18.2 × 4-1BB antibody targeting Claudin 18.2-positive tumor cells being developed for the treatment of first-line metastatic gastric cancer.

In January 2026, NovaBridge reported positive data from the givastomig Phase 1b dose expansion combination study in patients with first-line ("1L") gastric cancer. The data showed that givastomig produced a 77% ORR at 8 mg/kg and 73% ORR at 12 mg/kg (among 52 evaluable subjects), and a 16.9-month median progression-free survival at 8 mg/kg (among 27 evaluable subjects), with responses observed across a range of PD-L1 and Claudin 18.2 expression levels. Givastomig demonstrated favorable overall tolerability in combination with immunochemotherapy without dose-dependent toxicity.

In February 2026, NovaBridge initiated a global, randomized Phase 2 study of givastomig combined with immunochemotherapy in patients with HER2-negative, 1L metastatic gastric cancer.

In March 2026, NovaBridge reported givastomig’s potential eligibility for the U.S. Food and Drug Administration’s (FDA) Accelerated Approval Pathway in first-line HER2-negative, Claudin 18.2-positive, PD-L1-positive patients with gastroesophageal adenocarcinoma ("GEA").

In June 2026, the FDA granted Fast Track Designation to givastomig for the treatment of previously untreated HER2-negative advanced or metastatic GEA in combination with nivolumab and chemotherapy.

NovaBridge estimates that approximately 180,0001 patients are diagnosed with first-line GEA in the U.S., France, Germany, Italy, Spain, the United Kingdom and Japan, of which approximately 105,0002,3 cases are HER2-negative and Claudin 18.2-positive, the population givastomig targets. The Company also believes givastomig has broad potential across other Claudin 18.2-positive gastrointestinal malignancies, including biliary tract cancer and pancreatic ductal adenocarcinoma.

Upcoming Givastomig Milestones:


October 25, 2026: Poster presentation of Phase 1b combination dose expansion data at the European Society for Medical Oncology (ESMO) (Free ESMO Whitepaper) Congress 2026

As early as YE 2026: Initiate Phase 3 registrational study under a potential Accelerated Approval Pathway
VIS-101

VIS-101 is a potential best-in-class VEGF-A × ANG-2. It is a purpose-designed tetravalent peptibody being developed for neovascular retinal diseases. Positive Phase 2a data reported in March 2026 demonstrated favorable safety and tolerability results, meaningful visual acuity improvements, and encouraging durability in neovascular (wet) age-related macular degeneration ("nAMD") patients. VIS-101 is being developed for nAMD, diabetic macular edema ("DME"), and retinal vein occlusion ("RVO"), which together affect more than 57 million people globally.4

VIS-101 is being advanced through Visara. Consistent with NovaBridge’s operating model, Visara combines specialized ophthalmology expertise with NovaBridge’s strategic oversight, capital allocation, and business development capabilities to support focused execution and future growth of the ophthalmology franchise.

Upcoming VIS-101 Milestones:


H2 2026: Initiate Phase 2b program in nAMD

2027: Initiate global Phase 3 program in nAMD
1H Execution Highlights

During the first half of 2026 and subsequent period, NovaBridge continued to strengthen its leadership team to support the Company’s next phase of growth. NovaBridge appointed Srishti Gupta, MD, MPP, as Chief Executive Officer to lead corporate strategy, capital allocation, business development, and operational execution. The Company also appointed Mark Hagler as Chief Commercial Officer, adding commercial and portfolio planning expertise to support future development and partnership opportunities. At Visara, Jeffrey Nau, PhD, MMS, was appointed President and Chief Executive Officer to lead the advancement of VIS-101 and the continued build-out of the ophthalmology franchise. With these additions, NovaBridge continued executing its strategy to identify, develop, and create value from differentiated therapeutic assets. During the period, the Company advanced key pipeline programs toward important development milestones while continuing to evaluate opportunities to expand its portfolio and create long-term value for patients and shareholders.

In addition, NovaBridge is implementing enhancements to its segment disclosure and half-year reporting structure, expected to provide shareholders with clearer visibility into the performance of the Company and its operating subsidiaries.

First Half 2026 Financial Results

Cash Position

As of June 30, 2026, the Company had cash, cash equivalents, short-term investments, and equity investment at fair value of $215.9 million. Based on its current operating plan, the Company believes its cash position is sufficient to support the advancement of its portfolio through multiple anticipated clinical and strategic milestones, including givastomig’s planned Phase 3 interim data read-out in 2028.

Research & Development Expenses

Research and development expenses were $14.3 million for the six months ended June 30, 2026, compared to $4.1 million for the six months ended June 30, 2025. The increase was primarily driven by investment in clinical development activities for givastomig and the continued build-out of NovaBridge’s development capabilities to support current and future portfolio programs.

Administrative Expenses

Administrative expenses were $26.4 million for the six months ended June 30, 2026, compared to $8.3 million for the six months ended June 30, 2025. The increase was primarily driven by higher share-based compensation expense associated with equity awards granted in 2025, increased personnel-related costs as the Company expanded its organizational capabilities, and a one-time write-off of deferred offering costs related to the previously proposed HKEx dual primary listing.

Net Loss

Net loss was $37.9 million for the six months ended June 30, 2026, compared to $8.7 million for the prior-year period. Net loss per share attributable to ordinary shareholders was $0.14 compared to $0.05 in the prior-year period.

About Givastomig

Givastomig (TJ033721 / ABL111), a potential first-in-class CTIA, is a Claudin 18.2 × 4-1BB bispecific antibody. Givastomig conditionally activates T cells via the 4-1BB signaling pathway in the tumor microenvironment where Claudin 18.2 is expressed. Givastomig is being developed for potential treatment of gastric cancer, its current lead indication. Givastomig also has potential applicability across other Claudin 18.2+ gastrointestinal malignancies including biliary tract cancer and pancreatic ductal adenocarcinoma. Givastomig is being evaluated in a global, randomized Phase 2 study (NCT07432295), following positive topline results from a Phase 1b, multicenter, open-label study in first-line gastric cancer. NovaBridge expects to initiate a Phase 3 registrational study under a potential Accelerated Approval Pathway as early as year end 2026.

Givastomig is being jointly developed through a global partnership with ABL Bio, Inc. ("ABL Bio"). NovaBridge is the lead party and shares worldwide rights equally with ABL Bio, excluding Greater China and South Korea.

About VIS-101

VIS-101 (ASKG712/AM712) is a tetravalent VEGF-A × ANG-2 peptibody purpose-designed to be best-in-class. It targets retinal vascular diseases, including nAMD, DME, and RVO, which together affect more than 57 million people globally.⁴ VIS-101 is the only intravitreal therapeutic with two binding sites for each of VEGF-A and ANG-2, and carries the molecular weight of a full-length monoclonal antibody, a structural design intended to deliver a rapid, robust, and durable treatment response for patients with neovascular retinal diseases.

VIS-101 has completed initial safety and dose-escalation studies in both the U.S. and China, along with a randomized, dose-ranging Phase 2a study in China (NCT05456828). It is expected to advance to a randomized, controlled, dose-determining Phase 2b study in the second half of 2026, with anticipated initiation of a global Phase 3 program in 2027.

NovaBridge is the majority shareholder of Visara, which controls global rights to VIS-101 outside of Greater China and certain countries in Asia.

References:

1.
Markets include U.S., France, Germany, Italy, Spain, the United Kingdom, and Japan in 2025 based on Data Monitor Biomed Tracker, based on 1L treatment
2.
HER2-negative status of 78%. Van Cutsem E, Bang YJ, Feng-Yi F, et al. HER-2 screening data from ToGA: targeting HER2 in gastric and gastroesophageal junction cancer. Gastric Cancer 2015;18(3):476-84
3.
CLDN18.2 positive status of ~70%. Kohei Shitara, et al, 2023 ASCO (Free ASCO Whitepaper) Annual Meeting (June 2-6), poster #4035
4.
Invest Ophthalmol Vis Sci. 2021 Nov 24; 62 (14): 26. doi: 10.1167/iovs.62.14.26
Webcast/Conference Call Details:

NovaBridge will hold a webcast on Thursday, August 20, 2026 at 9:00 AM ET/9:00 PM China Standard Time to discuss recent corporate progress and financial results for the six months ended June 30, 2026.

Webcast Information:

·
Date: Thursday, August 20, 2026
·
Time: 9:00 AM ET/9:00 PM China Standard Time
·
Web Access – China: Click here
·
Webcast Access – All other locations: Click here
The live and archived webcast can also be accessed by visiting the NovaBridge Biosciences website on the Upcoming Events section of the Investors page. A replay of the webcast will be archived for at least 30 days after the event.

(Press release, NovaBridge Biosciences, AUG 20, 2026, View Source [SID1234670251])

Nykode Therapeutics Receives New U.S. Patent Strengthening Intellectual Property Protection for its fully individualized VB10.NEO cancer vaccine program

On August 20, 2026 Nykode Therapeutics ASA (OSE: NYKD), a clinical stage biopharmaceutical company dedicated to the discovery and development of novel immunotherapies, reported that the United States Patent and Trademark Office (USPTO) has issued U.S. Patent No. 12,697,377 B2, entitled "Therapeutic anticancer neoepitope vaccine" related to its individualized neoantigen therapy pipeline candidate, VB10.NEO.

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The newly issued patent relates to Nykode’s fully individualized neoantigen based cancer vaccine, VB10.NEO but also to similar modular neoantigen based cancer vaccines comprising alternative targeting units and/or dimerization units. The 20 year expiration date of this patent is January 5, 2037.

Michael Engsig, CEO of Nykode, said: "This new patent broadens the intellectual property protecting VB10.NEO and our wider neoantigen platform, and it arrives at a pivotal moment for the field. Merck and Moderna’s positive Phase 3 INTerpath-001 data is an important clinical validation of individualized neoantigen cancer vaccines. The question now moves from whether the modality works to which asset can be delivered reliably, and economically, across many indications. With a differentiated APC-targeted design, a neoantigen selection algorithm validated in patients, and an established attractive manufacturing supply chain, we believe VB10.NEO is well positioned to move into a larger set of indications."

Nykode presented data on the VB10.NEO program at the Neoantigen Summit in Amsterdam on July 22, 2026. Further details are available in the Company’s press releases: View Source

Nykode is actively exploring partnerships to advance VB10.NEO across a broad range of tumor types.

(Press release, Nykode Therapeutics, AUG 20, 2026, View Source [SID1234670252])

Zipalertinib Plus Chemotherapy First-Line Phase 3 REZILIENT3 Trial Data Selected for Presidential Symposium Presentation at the IASLC 2026 World Conference on Lung Cancer

On August 19, 2026 Taiho Oncology, Inc. and Cullinan Therapeutics, Inc. (Nasdaq: CGEM) reported that results from the planned interim analysis of the Phase 3 REZILIENT3 trial have been selected for presentation in the Presidential Symposium 2 at the International Association for the Study of Lung Cancer’s (IASLC) 2026 World Conference on Lung Cancer (WCLC), to be held September 12-15, 2026, in Seoul, South Korea. REZILIENT3 evaluates zipalertinib plus chemotherapy versus chemotherapy alone in the first-line treatment of patients with epidermal growth factor receptor (EGFR) exon 20 insertion mutation-positive non-small cell lung cancer (NSCLC).

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The Presidential Symposium 2 is a premier plenary session featuring notable advances in lung cancer research and treatment with the potential to change clinical practice.

Session information for the abstract is listed below. Full abstract details will be available via the conference website in accordance with IASLC embargo policies.

Title: Zipalertinib plus Chemotherapy for 1st-line NSCLC with EGFR Exon 20 Insertions: Results from the Phase 3 Trial (REZILIENT3)
Presenting Author: Dr. Daniel Tan Shao Weng, Duke Health, Singapore
Session Name: PL03 Presidential Symposium 2 Including Lectureship Award Presentations
Session Type: Presidential Symposium
Session Date: Monday, September 14, 2026
Session Time: 8 a.m. KST
Location: Plenary, Hall D2, 3F

About the REZILIENT3 Trial

This multicenter, randomized, controlled, open-label global trial enrolled 285 adults with previously untreated, locally advanced or metastatic non-squamous NSCLC with EGFR exon 20 insertion mutations. The primary objective of this trial is to assess progression-free survival in the zipalertinib plus chemotherapy arm versus the chemotherapy arm.

About Zipalertinib

Zipalertinib (development code: CLN-081/TAS6417) is an orally available small molecule designed to target activating mutations in EGFR. The molecule was selected because of its ability to inhibit EGFR variants with exon 20 insertion mutations. Zipalertinib is designed as a next generation, irreversible EGFR inhibitor for the treatment of a genetically defined subset of patients with non-small cell lung cancer. Zipalertinib is investigational and has not been approved by any health authority.

Zipalertinib is being developed by Taiho Oncology, Inc., its parent company, Taiho Pharmaceutical Co., Ltd., and in collaboration with Cullinan Therapeutics, Inc. in the U.S.

About EGFR Exon 20 Insertion Mutations

NSCLC is a common form of lung cancer and up to 4% of all cases globally have EGFR ex20ins.1 In the United States, approximately 16% of patients with NSCLC harbor EGFR mutations,1 with insertions at exon 20 accounting for up to 12% of these mutations.

(Press release, Taiho, AUG 19, 2026, View Source [SID1234670236])

Flatiron Health Brings Three Research Acceptances to WCLC 2026

On August 19, 2026 Flatiron Health reported its presence at the IASLC 2026 World Conference on Lung Cancer hosted by the International Association for the Study of Lung Cancer, with three research acceptances highlighting real-world evidence that advances precision medicine and treatment optimization in non-small cell lung cancer (NSCLC). The presentations demonstrate how Flatiron’s high-quality, longitudinal data reveals clinical insights that shape oncology decision-making across the globe.

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"Recent advances have fundamentally transformed treatment options for lung cancers, and our research highlights where and when these novel treatments are having an impact for patients in real-world practice," said Emily Castellanos, MD, MPH, Senior Medical Director and Head of Research Oncology at Flatiron Health. "Our WCLC research, spanning disease states, biomarker-defined subgroups, and treatment types, illuminates how to translate innovation into practice. By capturing this real-world complexity at scale through our Panoramic Database, we’re generating the evidence needed to guide clinicians in a rapidly evolving treatment landscape—enabling them to deliver personalized medicine to any patient that is in front of them."

Flatiron’s research at WCLC 2026 underscores the company’s position as the gold standard in oncology intelligence, delivering the trusted insights needed to guide the highest-stakes decisions in cancer care and drug development.

Research highlights include:

Genomic alterations without approved first-line targeted therapies in patients with NSCLC PD-L1 ≥50% treated with immunotherapy: Real-world evidence revealing treatment patterns and outcomes for patients with high PD-L1 expression who lack approved targeted therapy options, demonstrating how immunotherapy is being deployed in clinical practice and informing precision medicine strategies.
Real-world outcomes with chemoradiation and durvalumab consolidation in stage III KRAS G12C–mutant NSCLC in the US: Examining real-world treatment effectiveness and durability of durvalumab consolidation following chemoradiation in patients with stage III KRAS G12C-mutant disease, providing evidence on how emerging targeted approaches are translating to clinical outcomes.
Real-world treatment duration and outcomes among patients with early-stage NSCLC receiving adjuvant osimertinib: A retrospective cohort study analyzing treatment patterns, adherence, and survival outcomes in early-stage NSCLC patients receiving adjuvant osimertinib, revealing how precision medicine is reshaping the adjuvant treatment landscape.
These findings underscore Flatiron’s ability to transform patient experiences into actionable intelligence—connecting evidence to practice and enabling clinicians and researchers to make clearer decisions that drive better outcomes.

Join Flatiron Health at WCLC 2026 and follow Flatiron Health on X and LinkedIn for more updates.

Abstracts and Poster Presentations

Genomic alterations without approved 1L targeted therapies in patients with NSCLC PD-L1 ≥50% treated with immunotherapy
J.W. Riess, S. Viswanathan, S.K. Mhatre, S. Ding, I.K. Dhillon, S. Lambert, X. Ma, B. Herzberg
Author Affiliations: UC Davis Comprehensive Cancer Center, Gilead Sciences, Flatiron Health, Columbia University
Session: P1.106-234. Resectable NSCLC (Stages I–III)
Date/Time: Sunday, September 13, 2026 at 10:30 AM KST / UTC +9; 1h 30m
Location: Exhibits and Posters, Hall C, 3F

Real-world outcomes with chemoradiation and durvalumab consolidation in stage III KRAS G12C–mutant NSCLC in the US
D. Bruno, K. Sheffield, A. Brnabic, Q. Ma, R. Singh, K. Thoele, T. Puri, C.F. Avile, K. Schwed, M. Bye, A.M. Mehta, M. Pesavento
Author Affiliations: City of Hope Cancer Center, Eli Lilly and Company, Flatiron Health
Session: P2.249-276. Unresectable NSCLC (Stages I–III)
Date/Time: Monday, September 14, 2026 at 10:30 AM KST
Location: Exhibits and Posters, Hall C, 3F

Real-world treatment duration and outcomes among patients with early-stage NSCLC receiving adjuvant osimertinib: a retrospective cohort study
E. Singhi, X. Ma, C. Rinaldi, L. Kovacevic, Y. Liang, D. Simmons, M. Lupicka, I. Arslan, M. Sandelin, J. Pye, D. Nguyen
Author Affiliations: The University of Texas MD Anderson Cancer Center, Flatiron Health, AstraZeneca, City of Hope
Date/Time: Tuesday, September 15, 2026 at 11:55 AM KST
Location: Exhibits and Posters, Hall C, 3F

(Press release, Flatiron Health, AUG 19, 2026, View Source [SID1234670237])