Radspherin / Oncoinvent - LARVOL DELTA

Oncoinvent secures new patent expanding protection for Radspherin (Oncoinvent Press Release) - "The newly granted patent covers a key technical development to optimize Radspherin’s performance, specifically the size-controlled calcium carbonate microparticle technology. With this grant, patent protection for Radspherin in China is expanded in scope and duration, with a term extending to 2041. This complements the existing composition‑of‑matter patent, which is valid until 2035 (2036 in some jurisdictions). Corresponding patent applications from the same patent family remain under review in several major jurisdictions worldwide....Interim data from an ongoing, randomized, controlled phase 2 ovarian cancer trial is expected in 2026."

P2 data • Patent • Colorectal Cancer • Epithelial Ovarian Cancer • Fallopian Tube Cancer • Ovarian Cancer • Peritoneal Cancer

RAD-18-002: Study of Radspherin® in Colorectal Carcinoma Subjects With Peritoneal Carcinomatosis Treated With HIPEC (clinicaltrials.gov) - P1 | N=39 | Not yet recruiting | Sponsor: Oncoinvent AS

New P1 trial • Colorectal Cancer • Gastrointestinal Cancer • Oncology • Peritoneal Cancer • Solid Tumor

Study of Radspherin® in Recurrent Ovarian Cancer Subjects With Peritoneal Carcinomatosis (clinicaltrials.gov) - P1 | N=33 | Not yet recruiting | Sponsor: Oncoinvent AS | Trial completion date: Feb 2023 ➔ Oct 2023 | Trial primary completion date: Jan 2021 ➔ Dec 2022

First-in-human • Platinum sensitive • Trial completion date • Trial primary completion date • Gynecologic Cancers • Oncology • Ovarian Cancer • Peritoneal Cancer • Solid Tumor

RAD-18-002: Study of Radspherin® in Colorectal Carcinoma Subjects With Peritoneal Carcinomatosis Treated With HIPEC (clinicaltrials.gov) - P1 | N=39 | Not yet recruiting | Sponsor: Oncoinvent AS | Trial completion date: Feb 2022 ➔ Jan 2023 | Initiation date: Feb 2019 ➔ Dec 2019

Trial completion date • Trial initiation date • Colorectal Cancer • Gastrointestinal Cancer • Oncology • Peritoneal Cancer • Solid Tumor

RAD-18-002: Study of Radspherin® in Colorectal Carcinoma Subjects With Peritoneal Carcinomatosis Treated With HIPEC (clinicaltrials.gov) - P1 | N=39 | Not yet recruiting | Sponsor: Oncoinvent AS | Trial primary completion date: Dec 2020 ➔ Dec 2022

Trial primary completion date • Colorectal Cancer • Gastrointestinal Cancer • Oncology • Peritoneal Cancer • Solid Tumor

Study of Radspherin® in Recurrent Ovarian Cancer Subjects With Peritoneal Carcinomatosis (clinicaltrials.gov) - P1 | N=33 | Not yet recruiting | Sponsor: Oncoinvent AS | Trial completion date: Jun 2022 ➔ Feb 2023 | Initiation date: Feb 2019 ➔ Dec 2019

First-in-human • Platinum sensitive • Trial completion date • Trial initiation date • Gynecologic Cancers • Oncology • Ovarian Cancer • Peritoneal Cancer • Solid Tumor

RAD-18-002: Study of Radspherin® in Colorectal Carcinoma Subjects With Peritoneal Carcinomatosis Treated With HIPEC (clinicaltrials.gov) - P1 | N=39 | Recruiting | Sponsor: Oncoinvent AS | Not yet recruiting ➔ Recruiting

Enrollment open • Colorectal Cancer • Gastrointestinal Cancer • Oncology • Peritoneal Cancer • Solid Tumor

Study of Radspherin® in Recurrent Ovarian Cancer Subjects With Peritoneal Carcinomatosis (clinicaltrials.gov) - P1 | N=39 | Not yet recruiting | Sponsor: Oncoinvent AS

First-in-human • New P1 trial • Platinum sensitive • Gynecologic Cancers • Oncology • Ovarian Cancer • Peritoneal Cancer • Solid Tumor

RAD-18-002: Study of Radspherin® in Colorectal Carcinoma Subjects With Peritoneal Carcinomatosis Treated With HIPEC (clinicaltrials.gov) - P1/2 | N=67 | Active, not recruiting | Sponsor: Oncoinvent AS | Recruiting ➔ Active, not recruiting

Enrollment closed • Colorectal Cancer • Gastrointestinal Cancer • Oncology • Peritoneal Cancer • Solid Tumor

Study of Radspherin® in Recurrent Ovarian Cancer Subjects With Peritoneal Carcinomatosis (clinicaltrials.gov) - P1 | N=49 | Active, not recruiting | Sponsor: Oncoinvent AS | Recruiting ➔ Active, not recruiting

Enrollment closed • First-in-human • Platinum sensitive • Oncology • Ovarian Cancer • Peritoneal Cancer • Solid Tumor

RAD-18-002: Study of Radspherin® in Colorectal Carcinoma Subjects With Peritoneal Carcinomatosis Treated With HIPEC (clinicaltrials.gov) - P1/2 | N=67 | Recruiting | Sponsor: Oncoinvent AS | Phase classification: P1 ➔ P1/2 | N=39 ➔ 67 | Trial completion date: Mar 2023 ➔ Feb 2025 | Trial primary completion date: Dec 2022 ➔ Feb 2025

Enrollment change • Phase classification • Trial completion date • Trial primary completion date • Colorectal Cancer • Gastrointestinal Cancer • Oncology • Peritoneal Cancer • Solid Tumor

Study of Radspherin® in Recurrent Ovarian Cancer Subjects With Peritoneal Carcinomatosis (clinicaltrials.gov) - P1 | N=49 | Recruiting | Sponsor: Oncoinvent AS | N=33 ➔ 49 | Trial completion date: Oct 2023 ➔ Aug 2025 | Trial primary completion date: Dec 2022 ➔ Aug 2025

Enrollment change • First-in-human • Platinum sensitive • Trial completion date • Trial primary completion date • Oncology • Ovarian Cancer • Peritoneal Cancer • Solid Tumor

Study of Radspherin® in Recurrent Ovarian Cancer Subjects With Peritoneal Carcinomatosis (clinicaltrials.gov) - P1 | N=33 | Recruiting | Sponsor: Oncoinvent AS | Not yet recruiting ➔ Recruiting

Enrollment open • First-in-human • Platinum sensitive • Gynecologic Cancers • Oncology • Ovarian Cancer • Peritoneal Cancer • Solid Tumor

Safety and efficacy results from a phase 1 study of intraperitoneal alpha-emitting radium-224 labelled microparticles after cytoreductive surgery in patients with peritoneal recurrence of platinum-sensitive epithelial ovarian cancer (ESGO 2026) - "No grade ≥3 adverse events deemed related to Radspherin. At 24-months, only 1 of the 10 patients treated with the recommended dose experienced peritoneal recurrence, encouraging for the ongoing Phase 2 study at interval debulking surgery during first-line chemotherapy in ovarian cancer."

Clinical • P1 data • Platinum sensitive • Surgery • Epithelial Ovarian Cancer • Oncology • Ovarian Cancer • Peritoneal Cancer • Solid Tumor

Oncoinvent...announced that it will present final 24‑month results from its RAD-18-001 Phase 1 study of Radspherin after cytoreductive surgery in patients with platinum‑sensitive epithelial ovarian cancer and peritoneal recurrence at the European Society of Gynaecological Oncology (ESGO) 2026 Congress, taking place in Copenhagen, Denmark, from 26-28 February 2026. (Oncoinvent Press Release) - "21 patients enrolled across dose levels with a favourable safety profile and no dose‑limiting toxicities observed; No grade ≥3 adverse events considered related to Radspherin; Recommended dose selected at 7 MBq following dose escalation; Durable local disease control signal at 24 months: only 1 of 10 patients treated at the recommended dose experienced peritoneal recurrence."

P1 data • Platinum sensitive • Epithelial Ovarian Cancer • Ovarian Cancer

Experiences and Hopes Among Patients with Colorectal Carcinoma and Peritoneal Metastases Who Are Participating in an Early-Phase Clinical Trial. (PubMed, Cancers (Basel)) - "Background: Radspherin® is a novel α-emitting radiopharmaceutical administered intraperitoneally following complete cytoreductive surgery and hyperthermic intraperitoneal chemotherapy (CRS-HIPEC) for peritoneal metastases...Their willingness to participate in experimental treatment was shaped by trust in clinicians, clear communication, and a desire for extended survival. However, the burden of CRS-HIPEC-related side effects underscores the importance of tailored follow-up and support."

Journal • Colorectal Cancer • Fatigue • Oncology • Pain • Solid Tumor

Oncoinvent Reports Positive Final Data from Phase 1 Trial of Radspherin to Treat Ovarian Cancer (Oncoinvent Press Release) - "In this Phase 1 trial, 10 out of 21 patients received the highest and recommended intraperitoneal dose of 7 MBq Radspherin after dose escalation (1, 2, 4 and 7 MBq).The final 24-month data still reports that only 1 of these 10 patients had peritoneal recurrence, and peritoneal recurrence rate remains at 10%. Two additional patients were reported with lymph node metastases outside of the peritoneum, giving an overall recurrence rate of 30%. In similar populations, approximately 55-60% of patients receiving best standard of care would expect disease recurrence at this time point."

P1 data • Platinum resistant • Ovarian Cancer • Peritoneal Cancer

First experience with intraperitoneal 224Ra-labeled microparticles after cytoreductive surgery in patients with peritoneal recurrence of platinum-sensitive epithelial ovarian cancer. (PubMed, Gynecol Oncol) - P1 | "All dose levels were well tolerated, with no DLT observed. The highest activity dose of 7 MBq was selected as recommended dose for an expansion cohort. No grade ≥ 3 adverse events related to Radspherin were reported."

Journal • Platinum sensitive • Epithelial Ovarian Cancer • Hematological Disorders • Oncology • Ovarian Cancer • Peritoneal Cancer • Solid Tumor

Oncoinvent Presents Final Safety and Efficacy Results from the Phase 1/2a Trial of Radspherin to Treat Colorectal Cancer at the 15th PSOGI International Congress on Peritoneal Surface Malignancies (Oncoinvent Press Release) - "The final 18-month data reported that only 10 of these 36 patients (27.8 %) had peritoneal recurrence. Remarkably, only 2 out of the 36 patients experienced peritoneal metastases as the only site of disease recurrence. Further, at 18 months 61.1% (22 of 36) patients had experienced new metastases overall, giving a median disease-free survival of 13.5 months....The results strengthen the potential for Radspherin as a novel treatment option for patients with peritoneal metastases from colorectal cancer, demonstrating both clinical promise, as well as being well tolerated and safe to use..."

P1/2 data • Colorectal Cancer

Oncoinvent Reports Positive Final Data from Phase 1 Trial of Radspherin to Treat Ovarian Cancer (PRNewswire) - "The final 24-month data still reports that only 1 of these 10 patients had peritoneal recurrence, and peritoneal recurrence rate remains at 10%. Two additional patients were reported with lymph node metastases outside of the peritoneum, giving an overall recurrence rate of 30%....'We...look forward to interim results from our Phase 2 study next year'."

Clinical data • Platinum sensitive • Epithelial Ovarian Cancer • Fallopian Tube Cancer • Peritoneal Cancer

Thor Medical ASA…and Oncoinvent ASA…have entered into a strategic agreement for Thorium-228 radioisotopes to supply the Phase 3 clinical program for Radspherin, Oncoinvent’s lead product candidate. (Oncoinvent Press Release)

Commercial • Ovarian Cancer

RAD-18-002: Study of Radspherin® in Colorectal Carcinoma Subjects With Peritoneal Carcinomatosis Treated With HIPEC (clinicaltrials.gov) - P1/2 | N=47 | Completed | Sponsor: Oncoinvent AS | Active, not recruiting ➔ Completed | Trial completion date: Feb 2025 ➔ May 2025 | Trial primary completion date: Feb 2025 ➔ May 2025

Trial completion • Trial completion date • Trial primary completion date • Colorectal Cancer • Oncology • Peritoneal Cancer • Solid Tumor

Oncoinvent…advancing Phase 2 program in ovarian cancer (Oncoinvent Press Release) - "Regulatory approvals for additional sites for the randomized Phase 2 trial in ovarian cancer, with expected onboarding before end of 2025."

Trial status • Ovarian Cancer

BerGenBio and Oncoinvent, a rising innovator in radiopharmaceutical cancer therapies, announce proposed merger and a fully underwritten rights issue (PRNewswire) - "BerGenBio ASA...and Oncoinvent ASA...announce that they have entered into a merger agreement (the 'Agreement') to combine the two companies through a statutory merger (the 'Merger'), where BerGenBio will be the acquiring entity....The Merger puts BerGenBio's capital and listing to productive use by strengthening Oncoinvent's ability to execute on its clinical strategy and advance potentially life-changing treatments for patients with cancer in the abdominal cavity (peritoneal carcinomatosis)....The merged company will carry out a fully underwritten rights issue of NOK 130 million (the 'Rights Issue'). The proceeds from the Rights Issue is expected to provide the merged company with a cash runway into 2027, beyond the interim readout from Oncoinvent's ongoing Phase 2 trial in ovarian cancer, expected H2 2026."

Financing • M&A • P2 data • Epithelial Ovarian Cancer • Fallopian Tube Cancer • Peritoneal Cancer

Oncoinvent Announces Positive Final Data from Phase 1/2a Trial of Radspherin in Patients with Colorectal Peritoneal Metastases (Oncoinvent Press Release) - P1/2a | N=67 | RAD-18-002 (NCT03732781) | Sponsor: Oncoinvent AS | "Oncoinvent ASA...is thrilled to announce positive topline data from the Phase 1/2a clinical trial (RAD-18-002) evaluating Radspherin in patients with peritoneal metastases originating from colorectal cancer....Only 27.8%(10 of 36) experienced peritoneal disease recurrence at 18 months, a marked reduction compared to published data for standard of care, where approximately 50% of patients typically see peritoneal recurrence at this stage; At 18 months, 61.1%(22 of 36) of patients had experienced any recurrence, but notably, just 22.7% (5 of 22) had peritoneum as the first site of recurrence."

P1/2 data • Colorectal Cancer • Peritoneal Cancer