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Nykode Therapeutics AS Presents Comprehensive Preclinical Data, Optimized Manufacturing, and Durable Clinical Immunogenicity for their Individualized Neoantigen Therapy VB10.NEO Nykode Therapeutics AS presented comprehensive preclinical and clinical data on VB10.NEO, its individualized neoantigen therapy (INT), at the Neoantigen Summit in Amsterdam, reinforcing the program as a differentiated platform ready for strategic partnership. VB10.NEO is a wholly owned, DNA-based INT built on Nykode's proprietary antigen presenting cell (APC)-targeting technology and NeoSELECT™, an AI-driven neoantigen selection engine. The preclinical data demonstrates the strength of Nykode's differentiated APC-targeting, DNA-based vaccine platform, which shows a strong immunogenicity advantage over non-APC-targeted vaccines. New data showcases further enhanced immune responses with co-administration of molecular adjuvants. VB10.NEO generated robust CD4+ and CD8+ T cell responses across multiple tumor models, demonstrated stronger immune responses than peptide vaccines, durable tumor protection, and improved anti-tumor activity in combination with anti-CTLA4 or anti-PD-L1 antibody checkpoint inhibitors. Nykode is dedicated to leverage AI and machine learning to optimize vaccine design, with new data demonstrating improved antigen secretion and selection of complex antigen designs. Nykode has established a clinically validated end-to-end manufacturing process for VB10.NEO, achieving 100% manufacturing success across two clinical trials. Recent improvements have meaningfully reduced manufacturing time, with a current process of under six weeks from biopsy to release. This positions Nykode as one of the fastest and most robust INT developers on the market. Future establishment of an in-house process will create a scalable, time- and cost-competitive supply chain where Nykode’s simpler plasmid DNA manufacturing process will have an inherent cost-of-goods and needle to needle time advantage over alternative technologies such as mRNA-LNP. NeoSELECT™, Nykode's proprietary AI-powered neoantigen selection algorithm, demonstrated a significant correlation between highly ranked neoantigens and immunogenicity in patients. The platform was recently strengthened by a new U.S. patent extending protection through 2039. Across two clinical trials in advanced solid tumors, VB10.NEO was safe and well tolerated, with no serious vaccine-related adverse events. Vaccine-specific immune responses were observed in 88–100% of patients, including de novo T cell responses in 85% of patients, and remained durable for more than one year after the final dose. A new post-hoc analysis indicates that patients with a higher number of vaccine-induced immune responses showed a trend toward improved overall survival, while patients with baseline immune response to a higher number of the selected neoantigens had a significant correlation with improved overall survival, indicating that Nykode’s vaccines target clinically meaningful neoantigens. In patients with baseline immune response to a lower number of neoantigens, a higher number of de novo vaccine-induced immune responses was significantly correlated with an overall survival benefit, indicating the potential of VB10.NEO to target relevant neoantigens and provide clinical benefit to cancer patients with an insufficient immune response to these neoantigens. Nykode is actively exploring partnerships to advance VB10.NEO across a broad range of tumor types. New Risk • Jul 09
New minor risk - Market cap size The company's market capitalization is less than US$100m. Market cap: €84.7m (US$96.7m) This is considered a minor risk. Companies with a small market capitalization are most likely businesses that have not yet released a product to market or are simply a very small company without a wide reach. Either way, risk is elevated with these companies because there is a chance the product may not come to fruition or the company's addressable market or demand may not be as large as expected. In addition, if the company's size is the main factor, it is less likely to have many investors and analysts following it and scrutinizing its performance and outlook. Currently, the following risks have been identified for the company: Major Risks Share price has been highly volatile over the past 3 months (22% average weekly change). Dividend is not well covered by earnings and cash flows. Paying a dividend despite being loss-making. Paying a dividend despite having no free cash flows. Revenue is less than US$1m (US$556k revenue). Minor Risks Currently unprofitable and not forecast to become profitable over next 2 years (US$6.0m net loss in 2 years). Market cap is less than US$100m (€84.7m market cap, or US$96.7m). Board Change • May 20
High number of new and inexperienced directors There are 4 new directors who have joined the board in the last 3 years. The company's board is composed of: 4 new directors. 1 experienced director. No highly experienced directors. Director Christian Åbyholm is the most experienced director on the board, commencing their role in 2020. The company’s lack of experienced directors is considered a risk according to the Simply Wall St Risk Model. お知らせ • May 23
Nykode Therapeutics ASA Highlights New Data in Two Poster Presentations At the 2025 Asco Annual Meeting Nykode Therapeutics ASA announced the presentation of new data from two clinical trials evaluating its cancer immunotherapy candidates -- VB10.16 and VB10.NEO, both in combination with atezolizumab (Tecentriq®?), at the 2025 American Society of Clinical Oncology (ASCO) Annual Meeting in Chicago, Illinois. The two posters highlight the potential of Nykode's targeted immunotherapy platform in inducing robust immune responses in heavily pre-treated patient populations across multiple tumor types, with encouraging safety profiles. Integrative analysis of VB10.16 and atezolizumab in advanced HPV16-positive cervical cancer: Linking biomarker insights to clinical outcomes. Presenter: Kristina Lindemann, Department of Gynecological Oncology, Oslo University Hospital & Institute of Clinical Medicine, Faculty of Medicine, University of Oslo, Oslo, Oslo, Norway. In patients with persistent, recurrent, or metastatic HPV16-positive cervical cancer, VB10.16 combined with ateolizumab induced durable clinical responses. The VB C-02 trial demonstrated that stronger HPV16-specific T cell responses were associated with reduced systemic immunosuppression during treatment. Tumor microenvironment (TME) characteristics are associated with higher response rates. These findings support the importance of identifying the right patient population as well as elucidating the treatment effect on the systemic immunosuppression and highlights the promise of VB10.16 in combination with atezolIZumab, warranting further exploration. Induction of neoantigen-specific immune responses by VB10.NEO in combination with atezolizeumab in heavily pretreated patients with advanced solid tumors: Final analysis of the phase 1b VB N-02 trial. Presenter: Seebastian Ochsenreither, Charite University of Medicine Berlin Comprehensive Cancer Center, Berlin, Germany. VB10.NEO Inc, VB10. NEO, Nykode's personalized cancer neoantigen vaccine, in combination with atezoluzumab, induced neoantigen-specific immune response. Neoantigen-specific immune responses were observed in 100% of the patients and de novo immune responses were observed in 85% of patients, as measured by in vitro stimulated IFNg ELISpot. Expansion of durable T cell clones was seen in 82% of patients, suggesting persistence of the immune response. The trial enrolled heavily pre-treated patients across more than 10 indications, a median of 5 prior therapy lines and predominantly low or negative PD-L1 expression resulting in a median PFS reached before 2 months, limiting the opportunity for thorough assessment of long-term immune responses and clinically meaningful responses. VB10.N NEO in combination with atezolizing a median PFS reached before2 months, limiting the opportunity for comprehensive assessment of long-term immune response and clinically meaningful responses. V B10.NEO in combination With atezolizumab demonstrated a favorable safety profile. These results support further development of VB10.NEO In additional solid tumor settings.