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Transforming cancer care through direct alpha therapy February 2026 Oncoinvent
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2 3 4 1 4 3 5 6 Signals of efficacy: potential game changer in ovarian and colorectal cancers High unmet medical need in peritoneal cancers and metastases Non-biological, receptor independent mode of action with alpha emitter 2 SUMMARY Radspherin®: A Breakthrough in Post-Surgical Cancer Therapy Harnessing the advantages of radiopharmaceuticals with lower complexity and risk Developed by industry-leading radiopharmaceutical innovators with a proven track record, including the creators of Xofigo/Algeta (acquired by Bayer). 2 Advancements in ovarian cancer, Phase 1 trial delivered promising final results, with Phase 2 trial underway in patients
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Radiopharmaceutical excellence: expertise across the spectrum Board Management Scientific founders Stian Brekke Head of Regulatory Affairs Kristine Lofthus Chief Production Officer Ramzi Amri Chief Financial Officer Kari Myren Chief Medical Officer Anne-Kirsti Aksnes Chief Clinical Officer Gro Hjellum Chief Operations Officer Oystein Soug Chief Executive Officer Roy Larsen Øyvind Bruland Gillies O’Bryan-Tear Chair Kari Grønås Hilde Steineger Ingrid Teigland Akay Orlando Oliveira Anne Cecilie Alvik Johan Häggblad Olav Hellebo 3
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Peritoneal metastases - urgent need for novel treatments 4 • Peritoneal metastases arise from many different primary cancers • The only treatment option with curative intent is surgery, effect of systemic therapy limited • Surgery leaves behind micro-metastases giving rise to new metastases and disease progression • The abdominal cavity functions, in practice, as a‘closed compartment’ UNMET MEDICAL NEED
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The main cause of death in ovarian cancer • Despite a comprehensive treatment approach, the majority of patients experience disease recurrence • Ovarian cancer rarely metastasize hematogenously, recurrences almost exclusively confined to the peritoneum • Need for improved first-line treatments that keep patients in remission – local control in the peritoneum is key to improving life expectancy • FDA Fast Track Lengyel Am J Pathol. 2010 Sep; 177(3): 1053–1064. González-Martín N Engl J Med 2019;381:2391-402 Jansen et al. Ann Med Surg (Lond). 2023 May; 85(5): 1539–1545. 5 UNMET MEDICAL NEED
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• Combining alpha-emitting 224Ra with CaCO3 microparticles • Half-life 3.6 days • Therapy with depot effect - 75% of radiation dose delivered the first week • Shelf life 8 days allowing for centralized manufacturing • Good raw material availability and simple manufacturing 6 Radspherin® - alpha therapy targeted to and retained in the peritoneum Radspherin® TREATMENT CONCEPT
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• Combining alpha-emitting 224Ra with CaCO3 microparticles • Half-life 3.6 days • Therapy with depot effect - 75% of radiation dose delivered the first week • Shelf life 8 days allowing for centralized manufacturing • Good raw material availability and simple manufacturing 7 Radspherin® - alpha therapy targeted to and retained in the peritoneum Radspherin® How does it work? • Delivering a high dose of alpha-radiation directly to the peritoneum through an in- dwelling catheter • Administration 1-3 days post-surgery • High energy and short radiation range enables effective killing of the targeted metastases while sparing the surrounding normal tissue TREATMENT CONCEPT
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Ph 1/2a 1H25 2H25 1H26 1H27 Ovarian N = 96Ph 2 Ovarian Colorectal Ongoing clinical development 2H26 2H27 2H281H28 8 FinalInterim Interim Final Final Completed Upcoming milestones Interim
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Ph 1/2a 1H25 2H25 1H26 1H27 Ovarian N = 96Ph 2 Ovarian Colorectal Ongoing clinical development 2H26 2H27 2H281H28 9 FinalInterim Interim Final Final Completed Upcoming milestones Interim
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RAD-18-001: in patients after secondary debulking surgery of platinum-sensitive recurrent ovarian cancer • single-arm open label study • 3 + 3 dose-escalation (1, 2, 4, 7 MBq) • 24 months follow-up 4 clinical sites: • Oslo, Norway(PI: Yun Wang) • Leuven, Belgium (PI: Els van Nieuwenhuysen) • Madrid, Spain (PI: Luis Chiva) • Pamplona, Spain (PI: Luis Chiva) Expansion cohort 7 MBq dosimetry 7 MBq Dose escalation cohort 1 MBq 2 MBq 4 MBq 7 MBq Radspherin® - phase 1 study in ovarian cancer Total number of patients recommended dose 7MBq, n=10 10
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11 Ovarian cancer: Preventing disease progression 24 months data from 10 patients receiving 7 MBq dose vs historical recurrence rates PHASE 1 RESULTS “These final results are truly encouraging, suggesting that Radspherin® could help delay disease progression and offer patients hope for longer, healthier lives.” Dr Luis Chiva, Principal Investigator and Director of Department of Obstetrics and Gynecology Clinica Universidad de Navarra Coleman et al. N Engl J Med. 2019 Nov 14;381(20):1929-1939 Harter et al. N Engl J Med. 2021 Dec 2;385(23):2123-2131 Shi et al. Lancet Oncol. 2021 Apr;22(4):439-449 Recurrence rate 11 ~55-60%* Historical controls *Peritoneal recurrence rates or distribution of recurrences not available in historical control 30% Overall recurrence rate 30 % • Additionally, two lymph node recurrences 10% Peritoneal recurrence rate 10 %
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Ph 1/2a 1H25 2H25 1H26 1H27 Ovarian N = 96Ph 2 Ovarian Colorectal Ongoing clinical development 2H26 2H27 2H281H28 12 FinalInterim Interim Final Final Completed Upcoming milestones Interim
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The trial: (RAD-18-002) Radspherin after cytoreductive surgery and HIPEC in patients with peritoneal metastasis from colorectal cancer • Single-arm open label study • 3 + 3 dose-escalation (1, 2, 4, 7 MBq) • 18 months follow-up Two clinical sites: • Oslo, Norway (PI: Stein Larsen) • Uppsala, Sweden (PI: Wilhelm Graf) Dose escalation cohort Expansion cohort 1 MBq 2 MBq 4 MBq 7 MBq 7 MBq dosimetry 7 MBq Split dose 2×3.5 MBq Design: Phase 1/2a in colorectal cancer (n=4) (n=3) (n=4) (n=3) (n=6) (n=24)(n=3) Total number of patients recommended dose 7MBq, n=36 13
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14 Colorectal cancer: final phase 1/2a data confirm peritoneal control Topline 18-months data of 36 patients receiving 7 MBq dose vs historical recurrence rates PHASE 1 RESULTS "It’s highly encouraging to see patients treated with Radspherin achieving outcomes that exceed expectations for this challenging population. ” Dr. Stein Gunnar Larsen Principal Investigator at the Oslo University Hospital, Norway Quenet et al. Lancet Oncol. 2021 Feb;22(2):256-266 Peritoneal recurrence rate Radspherin® Historical control 28% Peritoneal recurrence rate Peritoneal recurrence rate ~50% 28% 50 % 14
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Median overall survival - from the time of recurrence: • After distant metastasis only: 44 months • After peritoneal metastasis: 22 months 5-year overall survival – from the time of treatment • Distant metastasis only: 53 % • Peritoneal metastasis: 19 % Frøysnes et al. J Surg Oncol. 2016 Aug;114(2):222-7 1Treatment with standard of care for resectable peritoneal metastases from colorectal cancer, i.e. cytoreductive surgery and hyperthermic intraperitoneal chemotherapy Controlling peritoneal disease may significantly improve survival in colorectal cancer 1/3 peritoneal only 1/3 distant only 1/3 combined peritoneal and distant 15 Impact of site of first site of recurrence 1First disease recurrence after treatment 1
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• Radiation dose retained in the peritoneal cavity • Absorbed doses to other organs well below toxicity levels • No dose limiting toxicity • Only two SAEs possibly related to Radspherin* Well tolerated and safe to use No evidence of systemic radiation toxicity • Low radioactivity dose in blood and urine • No precautions related to external exposure required Low exposure for hospital staff *Per cut-off date of annual DSUR March 2025 - one event of small bowel perforation, 72 days after Radspherin administration - one event of procedural complication during Radspherin administration (disconnection syringe-catheter) 16 PHASE 1/2A RESULTS Strong safety profile demonstrated in the completed phase 1/2a studies in ovarian and colorectal cancer
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Tissue Tolerance levels for external beam radiotherapy Corresponding administered activity of Radspherin (MBq)* Colon < 11 Gy >800 Small intestine ≤ 15 Gy >1 000 Stomach ≤ 45 Gy >3 500 Liver ≤ 30 Gy >150 Kidney < 20 Gy ~100 Threshold for possible major hematotoxicity Red bone marrow ≤ 2 Gy ~20 *To compare doses from alpha-radiation and external beam radiotherapy or beta-radiation head-to-head, a relative biological effectiveness (RBE) factor of 5 must be used for alpha-radiation Emami et al. Reports of radiotherapy and Oncology, 2013. Hobbs et al. Phys Med Biol 2012 May 21;57(10):3207-22 • Absorbed doses below 1 Gy* for all organs measured • Highest absorbed doses to organs at risk for endosteal bone surface cells, followed by kidney, liver, and red bone marrow • No signs of hematological, kidney or liver toxicity observed in clinical studies Microparticle retention limits off-target organ exposure PHASE 1/2A RESULTS 17
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Phase 1 ovarian cancer • Final 18 months data • 36 patients 7 MBq • June 2025 • Final 24 months data • 10 patients 7 MBq • October 2025 Phase 2 ovarian cancer • 2H26: First randomized interim data • 2028: Final data Phase 1/2a colorectal cancer 18 Near-term significant milestone
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Ph 1/2a 1H25 2H25 1H26 1H27 Ovarian N = 96Ph 2 Ovarian Colorectal Ongoing clinical development 2H26 2H27 2H281H28 19 FinalInterim Interim Final Final Completed Upcoming milestones Interim
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SoC+ Radspherin Control: SoC Primary endpoint: progression- free survival Safety run-in 6 patients 2:1 Imaging every 3 months up to 24 months Patient population • primary advanced ovarian cancer • undergoing neoadjuvant chemotherapy and interval debulking surgery • eligible for complete resection • HRD negative Long-term follow- up for up to 5 years for progression and survival 20 PHASE 2 PROGRAM – OVARIAN CANCER Randomized Phase 2 study in first-line treatment of ovarian cancer HRD: Homologous Recombination Deficiency ITT: Intention to treat SoC: Standard of Care 10 active study sites: NO, BE, ES (4), UK(2), IT, USA Randomised cohort ~110 ITT patients NO: Norway BE: Belgium ES: Spain UK: United Kingdom IT: Italy USA: United States of America
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• Distinguished by its unique mechanism of action • Untapped market – no modern therapies and limited industry development in the specific area of peritoneal metastases • Strategic advantage: complementing cytoreductive surgery, reduced threats from new therapies Limited competition • Large number of patients ovarian and colorectal cancer patients in US and Europe • Treatment is receptor- and target- independent –effective for peritoneal cancers regardless of origin – i.e., gastric cancer; orphan indication in the US, highly frequent in Asia, and prophylactic in high- risk patients – Significant potential for label expansion • Future opportunities for tailoring to treatment of cancers in other body cavities High addressable patient number Potential for Radspherin® to emerge as a leading treatment option for patients with resectable peritoneal metastases MARKET OPPORTUNITY Peritoneal metastases represent a significant market opportunity 21 • Surgery is and will remain the cornerstone of treatment • Treatment given 1-3 days post-operative while the patient is still hospitalized • Simple and quick bedside administration • Single and localized administration – sustained therapeutic efficacy and decreased risk for off-target effects Adds perfectly to existing patient flow
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Ways to target cancer with radiopharmaceuticals • Some radionuclides naturally targets certain organs. 223Ra Xofigo goes to bone, 131I goes to the thyroid • Simple, proven in routine clinical practice, selective for tissues • Limited to diseases with natural avidity, less adaptable Natural homing Molecular targeting Direct radiotherapy • Radioligands: Biological targeting agent linked to a radioactive payload e.g. Lutathera, Pluvicto • Large potential • Complex, risk of off-target effects • Physically trapping radioactivity in an organ: e.g. Radspherin®, TheraSphere (Boston Scientific), REYOBIC (Plus) • Non-systemic delivery: High local concentration, minimal systemic toxicity • Requires direct access to site, not suitable for systemic disease
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• Peritoneal metastases arise from many different cancers • Radspherin® is a receptor-independent treatment: – effective regardless of the origin of the primary malignancy 23 MARKET OPPORTUNITY Pipeline in one product - broad clinical application Intraperitoneal origin Lung cancer Breast cancer Malignant melanoma Kidney cancer Peritoneal cavity Extraperitoneal origin Primary cancers Mesothelioma Primary peritoneal cancer Gastric cancer Pancreatic cancer Appendiceal cancer Sarcoma Small bowel cancer Endometrial cancer Cholangiocarcinoma Ovarian Cancer Colorectal Cancer
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While the radiopharma sector is largely concentrated in two indications, Oncoinvent pursues peritoneal metastases Notes: 1) GEP-NET: Gastroenteropancreatic neuroendocrine tumors Source: Guggenheim, Oppenheimer, Company information, Company websites and presentations 24 Peritoneal metastases Prostate cancerGEP-NET1)Other 212Pb Snapshot of the Radiopharma Landscape 224Ra Development stage Company type Preclinical Early Clinical Late Clinical Commercial Public Private • Harnessing the advantages of radiopharmaceuticals with reduced complexity and risk relative to novel radioligand therapies • Oncoinvent is pioneering peritoneal metastases where competition is lower • Oncoinvent’ s drug candidate is based on 224Ra which has good raw material supply and long enough half-life (3.6 days) to enable efficient logistics and wide-ranging distribution CommentaryOther 177Lu 225Ac MARKET OPPORTUNITY
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25 Targeting by proximity – brilliant in its simplicity Bypasses the need of biological targeting and systemic distribution of the radioactive payload Increases the radionuclide exposure at the tumor target sites Reduces the radionuclide exposure to radiation sensitive organs Retains the radioactive payload in the target area
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Oncoinvent has in-house GMP production capability 224Ra produced from 228Th, which has multiple sources Microparticles and finished goods produced in-house GMP: Good manufacturing practice 26 MANUFACTURING AND SUPPLY In-house GMP pilot plant with attractive capabilities • Capacity of ~200 doses Radspherin annually, outsourcing and scale-up required for phase 3 • On selective basis offer GMP laboratory services to similar non-competing companies
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27 INTELLECTUAL PROPERTY Radspherin® - solid multilayer intellectual property protection Radspherin® formulation • Filed in 2021 in: USA, Europe, Japan, China, Canada, India, Mexico, Hong Kong • Patent expiry 2041 with an option for 5 years extension Radspherin® composition of matter & use • Granted in US, EU, China, Japan and additional countries • Patent expiry 2035 (2036 in some countries) with an option for 5 years extension Radium-224 combination with PARP inhibitors • Filed in 2020 in: USA, Europe • Patent expiry 2041 with an option for 5 years extension Composition of matter Formulation Clinical dosage/use Combination Radspherin® clinical doses, application: use patent • Filed in January 2024 • Patent expiry: 2044 with an option for 5 years extension
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1 2 3 4 1 3 2 4 5 Signals of efficacy: potential game changer in ovarian and colorectal cancers High unmet need and limited competition Targeted, non-biological, receptor independent lower risk mode of action 28 SUMMARY A unique radiopharmaceutical opportunity Compatible with established treatment regimes - adds well to existing patient flow Experienced team with track record from radiopharmaceutical developments and exits