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Nykode Therapeutics : Q4 2025 Financial Results Q4 2025 Webcast presentation

Nykode Therapeutics : Q4 2025 Financial Results Q4 2025 Webcast

Nykode Therapeutics AsaFebruary 27, 20264
Nykode Therapeutics : Q4 2025 Financial Results Q4 2025 Webcast presentation

About this update from Nykode Therapeutics Asa

Q4 2025 Results Presentation February 25, 2026 Today's presenters from Nykode MICHAEL ENGSIG Chief Executive Officer AGNETE FREDRIKSEN Chief Scientific Officer & Business Development HARALD GURVIN Chief Financial Officer Focused strategy with clear value drivers Abi-suva (VB10.16) Randomized clinical trial (Abili-T) in 1L R/M head and neck cancer on track to deliver meaningful interim results within 2027 APCs VB10.NEO Well positioned to leverage key peer readouts in Individualized Neoantigen Therapy expected within the next 15 months Tolerance Aiming to become the best-in-class antigen-specific immune tolerance (ASIT) platform Capitalization Well capitalized to reach significant inflection points Highlights Abi-suva Abili-T protocol submitted to UK regulatory authorities in November and relevant EU regulatory authorities in December Approved by UK regulatory authorities in December Announced interim data from the VB-C-03 Trial showing an ORR of 38.5%, significantly higher than current standard of care (19%). Further details to be presented at ICHNO in March 2026 VB10.NEO U.S. patent granted relating to the company's proprietary NeoSELECT TM platform used for the selection of neoantigens for VB10.NEO, strengthening our intellectual property portfolio. Presented new analyses from two clinical trials further validating NeoSELECT's ability to identify neoantigens that drive strong and durable immune responses. Tolerance New results showcasing the ASIT platform's ability to regulate human immune cells with potential translatability and bridging between preclinical and human setting for treatment of autoimmune diseases Abi-suva Nykode Therapeutics | Q4 '25 webcast | Non-confidential 6 The current focus of abi-suva is 1L r/m HNSCC with the potential to expand to additional indications and lines of treatment Nykode Therapeutics | Q4 '25 webcast | Non-confidential Future potential for Abi-suva HPV16+ driven cancers Incidence of HPV16+ driven cancers in EU and US is ~ 134,000 1,2,3 VB-C-02 trial indicates a strong and durable clinical effect in advanced cervical cancer patients Sales in HPV+ driven cancers expected to increase with new treatments available and treatment in earlier settings Current focus of Abi-suva 1L r/m HNSCC Incidence of HPV16+ driven HNSCC cancers in EU and US is ~ 63,000 1,2,3 Unmet need as current SOC has 19% ORR and 12.3 mOS. Most HNSCC treatments in development are focused on HPV negative population. HPV16+ HNSCC sales are expected to grow to $2.3bn in 2034 (CAGR of 9.2%) 4 1. Cancer Stat Facts: Oral Cavity and Pharynx Cancer, 2024: https://seer.cancer.gov/statfacts/html/oralcav.htm l . Laryngeal: Laryngeal Cancer Overvie w - American Association for Cancer Research (AACR) . 2. Cancer Facts & Figures, 2024: https://www.cancer.org/content/dam/cancer-org/research/cancer-facts-and-statistics/annual-cancer-facts-and-figures/2024/2024-cancer-facts-and-figures-acs.pd f , 3. Global Data (Cervical Cancer), 2022. Epidemiology Analysis. 4. Delveinsight: HPV16-positive Head and Neck Squamous Cell Carcinoma (HNSCC) - Market Insight, Epidemiology, and Market Forecast - 2030 (December 2024) Abi-suva shows strong and consistent clinical effect across several trials and HPV16 driven indications Objective response rate (ORR) of abi-suva in combination with CPI compared to historical CPI monotherapy 1 ORR 39% Abi-suva + pembro CPI mono 1 = 19% 3 (Pembrolizumab) CPI mono 1 = 16% 2 (Atezolizumab) Abi-suva + atezo Δ~81% Δ~103% ORR 29% VB-C-02 VB-C-03 2L+ r/m Cervical Cancer 1L r/m Head and Neck Cancer Abili-T randomized controlled trial enrolling up to 100 patients, designed to demonstrate contribution of abi-suva Key inclusion criterion Treatment Endpoints HPV16+ r/m HNSCC PD-L1+ Measurable disease ECOG PS 0-1 GRIm 0-1 Abipapogene suvaplasmid + pembrolizumab R (1:1) Pembrolizumab ORR PFS DOR RMDOR DCR OS TEAEs Immunogenicity ctDNA Interim analyses for efficacy are planned throughout the trial, with the first analysis of approx. 33% of patients expected during 2027 Significant advancements in the Abili-T trial Achieved since announcement of trial (August 2025): Protocol submitted to UK regulatory authorities in November Protocol submitted to relevant EU regulatory authorities in December Secured supply of pembrolizumab with MSD Protocol approved by UK regulatory authorities in December Next steps: Protocol expected approved by relevant EU regulatory authorities in 1H 2026 First patient dosed expected in 1H 2026 Abili-T will have meaningful interim readout within 2027 VB10.NEO Nykode Therapeutics | Q4 '25 webcast | Non-confidential 11 VB10.NEO delivers on all key success factors for an ideal Individualized Neoantigen Therapy candidate Clinical experience Nykode's two clinical trials* show clear vaccine induced immune responses Antigen selection NeoSELECT - Nykode's proprietary algorithm selects relevant NeoAntigens Supply chain Nykode has a robust and proven supply chain with competitive turnaround-time Costs Nykode's DNA based therapy has advantage on cost and manufacturing complexity Nykode is well positioned as most attractive unencumbered INT ready to leverage peer readouts * N-01 and N-02 Further important milestones New U.S. Patent Granted for VB10.NEO relating to the proprietary NeoSELECT TM platform selecting neoantigens for VB10.NEO Presenting new data from 2 clinical trials at SITC NeoSELECT prioritizes immunogenic neoantigens with clinical and immunological relevance Peer readouts within next 15 months can create a strong conviction for INTs VB10.NEO is we l positioned in the field of individualized neoantigen therapies. VB10.NEO meets requirement for ideal INT technology Continuing to strengthen this position with key activities focused on further optimizing robustness across products Tolerance Nykode Therapeutics | Q4 '25 webcast | Non-confidential 15 Key factors for a successful ASIT platform An ASIT platform should have following key factors to succeed: Convenient delivery route supporting clinical translation Regulate all major autoreactive disease-causing cells Long durable reversion of disease symptoms Therapeutic efficacy across diseases MultiAg Capability Immune regulation Durability Efficacy Manufacture & Delivery AI competencies for multi-antigen drug design to address disease complexity Continued progress with the ASIT platform Presented new preclinical data indicating that our ASIT platform has the ability to modulate the humoral component of the immune response by reducing auto-antibodies in an EAE model, even after disease on-set Further expanding the ASIT platform into a new preclinical disease model, Vitiligo, demonstrating that Nykode's targeted approach is capable of reducing CD8+ disease-mediated T cell response. Clinical translatability: proof of principle on human cells Tuneable immune regulation observed with novel human specific APC-targeting Binding of Nykode APC Targeted Therapy to human APCs APC targeting can either increase or decrease immune stimulation Human Targeting Units PBMC Non-targeted Therapy 1000 nM APC 1 Targeted Therapy 2nM APC 2 Targeted Therapy Non-targeted Therapy 2nM APC 25000 TNFα (pg/mL) 20000 15000 10000 5000 CD40 agonist APC 1 Targeted Therapy APC 2 Targeted Therapy CD40 agonist Non-targeted Therapy APC 1 Targeted Therapy APC 2 Targeted Therapy 0 TNFα secretion + CD40 agonist 2000 IL-6 (pg/mL) 1500 1000 500 0 IL-6 secretion + CD40 agonist Nykode to present progress for the ASIT platform Nykode will present new pre-clinical data from our Antigen-Specific Immune Tolerance Platform at the following conferences in Q1 2026: 9 th Annual Antigen-specific Immune Tolerance Summit 3 rd - 5 th March, Boston, USA Present new pre-clinical data on 5 th March In addition, poster and panel discussion NextGen Biomed 24 th - 25 th March, London, UK Nykode to present on 25 th March Q4 2025 Financial Results Nykode Therapeutics | Q4 '25 webcast | Non-confidential 20 Income Statement Amounts in USD '000 Q4 2025 Q4 2024 YTD 2025 YTD 2024 Revenue from contracts with customers - 6,773 - 8,679 Other income - 121 453 479 Total revenue and other income - 6,894 453 9,158 Employee benefit expenses 3,851 8,257 13,552 31,037 Other operating expenses 3,734 4,079 13,450 24,201 Depreciation 505 547 2,039 2,251 Operating profit (loss) (8,090) (5,989) (28,588) (48,331) Finance income 657 2,387 13,287 9,000 Finance costs 613 3,385 2,396 6,182 Profit (loss) before tax (8,046) (6,987) (17,697) (45,513) Income tax expense (49) (231) (5,457) (6,692) Profit (loss) for the period (7,997) (6,756) (12,240) (38,821) Revenue from contracts with customers Decrease in 2025 mainly due to termination of agreement with Genentech in Q4 2024 No income from Regeneron agreement in 2025 Other income Government grants from SkatteFUNN Employee benefit expenses Decrease in 2025 mainly due to reduced organization following organizational streamlining Other operating expenses Reduction in 2025 mainly due to reduced clinical activities Finance income/costs Mainly interest income and unrealized currency movements in 2025 Balance Sheet 32,224 38,064 1,602 60,289 61,891 99,955 Amounts in USD '000 31/12/2025 31/12/2024 ASSETS Non-current assets Other non-current receivables Total non-current assets Current assets Other receivables Cash and cash equivalents Total current assets TOTAL ASSETS 28,601 36,415 1,668 115,398 117,066 153,481 Cash and cash equivalents Cash position of $60.3m at December 31, 2025 Other non-current receivables Property, plant and equipment 3,044 3,741 Right-of-use assets 2,640 4,001 Intangible assets 72 72 Deferred tax asset 84 - Mainly reflects the NOK 325m payment to the Norwegian Tax Authorities (NTA) in the fourth quarter of 2023 following the decision by the NTA on the tax treatment of upfront payments received under a license agreement entered into in 2020 Nykode has appealed the decision to the Norwegian Tax Administration (Norw: Skatteklagenemda) Received letter from the Norwegian Tax Administration in Q1 2026 that an outcome of the appeal can be expected in the first half of 2026 Receivable is in NOK and USD equivalent will fluctuate with exchange rate movements Amounts in USD '000 31/12/2025 31/12/2024 EQUITY AND LIABILITIES Equity Share capital 367 367 Share premium 96,707 128,986 Other capital reserves 18,653 18,683 Other components of equity (3,006) (3,060) Retained earnings (21,184) (8,762) Total equity 91,537 136,214 Non-current liabilities Non-current lease liabilities 1,300 2,145 Other non-current liabilities 926 822 Deferred tax liabilities - 5,201 Total non-current liabilities 2,226 8,168 Current liabilities Current lease liabilities 1,250 1,293 Trade and other payables 4,074 3,679 Current provisions 868 4,103 Income tax payable - 24 Total current liabilities 6,192 9,099 Total liabilities 8,418 17,267 TOTAL EQUITY AND LIABILITIES 99,955 153,481 Balance Sheet - contd. Equity Total equity of $91.5m as per December 31, 2025 Equity ratio of 92% Outlook and closing remarks Nykode Therapeutics | Q4 '25 webcast | Non-confidential 24 Cash runway Cash runway into 2028-2029* Cash runway exceeding significant inflection points Next 12 months C-03 interim data (ICHNO Q1 26 + additional conference Q2 26) Abili-T protocol approved by relevant EU authorities (1H 26) Abili-T first patient dosed (1H 26) Expected key peer readouts on INT Continued progress on ASIT platform Well-positioned to execute strategy and meet inflection points Nykode Therapeutics | Q4 '25 webcast | Non-confidential Next 12-24 months Abili-T first interim analysis (2027) Continued expected key peer readouts on INT *2029 based on a predicated positive outcome of the pending tax case 25 Q&A Michael Engsig, CEO Agnete Fredriksen, CSO and Business Development Harald Gurvin, CFO Nykode Therapeutics | Q4 '25 webcast | Non-confidential 26 UNLOCKING THE FUTURE OF MEDICINE Contact: [email protected] https://nykode.com/investors/ Nykode Therapeutics | Q4 '25 webcast | Non-confidential Attention : This is an excerpt of the original content. 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