Annuncio • Jul 22
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: kr940.5m (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 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). Share price has been volatile over the past 3 months (7.1% average weekly change). Market cap is less than US$100m (kr940.5m market cap, or US$96.7m). New Risk • Feb 26
New major risk - Revenue size The company makes less than US$1m in revenue. Total revenue: US$453k This is considered a major risk. Companies with a small amount of revenue 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 (12% 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. Earnings are forecast to decline by an average of 23% per year for the foreseeable future. Revenue is less than US$1m (US$453k revenue). Minor Risk Currently unprofitable and not forecast to become profitable over next 2 years (US$20m net loss in 2 years). Recent Insider Transactions • Nov 28
Chief Executive Officer recently bought kr100k worth of stock On the 24th of November, Michael Engsig bought around 46k shares on-market at roughly kr2.16 per share. This transaction amounted to 65% of their direct individual holding at the time of the trade. In the last 3 months, they made an even bigger purchase worth kr100k. Michael has been a buyer over the last 12 months, purchasing a net total of kr200k worth in shares. Reported Earnings • Nov 25
Third quarter 2025 earnings: EPS and revenues exceed analyst expectations Third quarter 2025 results: US$0.01 loss per share (improved from US$0.03 loss in 3Q 2024). Net loss: US$3.66m (loss narrowed 62% from 3Q 2024). Revenue exceeded analyst estimates by 132%. Earnings per share (EPS) also surpassed analyst estimates by 59%. Revenue is expected to decline by 154% p.a. on average during the next 2 years, while revenues in the Biotechs industry in Europe are expected to grow by 13%. Over the last 3 years on average, earnings per share has increased by 23% per year but the company’s share price has fallen by 56% per year, which means it is significantly lagging earnings. Recent Insider Transactions • Oct 13
Chief Executive Officer recently bought kr100k worth of stock On the 10th of October, Michael Engsig bought around 56k shares on-market at roughly kr1.79 per share. This transaction increased Michael's direct individual holding by 4x at the time of the trade. This was the largest purchase by an insider in the last 3 months. This was Michael's only on-market trade for the last 12 months. New Risk • Oct 10
New minor risk - Share price stability The company's share price has been volatile over the past 3 months. It is more volatile than 75% of Norwegian stocks, typically moving 6.4% a week. This is considered a minor risk. Share price volatility indicates the stock is highly sensitive to market conditions or economic conditions rather than being sensitive to its own business performance, which may also be inconsistent. It also increases the risk of potential losses in the short term as the stock tends to have larger drops in price more frequently than other stocks. Currently, the following risks have been identified for the company: Major Risks 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. Earnings are forecast to decline by an average of 7.2% per year for the foreseeable future. Minor Risks Currently unprofitable and not forecast to become profitable over next 3 years (US$25m net loss in 3 years). Share price has been volatile over the past 3 months (6.4% average weekly change). Market cap is less than US$100m (kr567.5m market cap, or US$56.2m). Reported Earnings • Aug 27
Second quarter 2025 earnings released Second quarter 2025 results: Net income: US$859.0k (up US$8.25m from 2Q 2024). Revenue is expected to fall by 102% p.a. on average during the next 3 years compared to a 2.7% decline forecast for the Biotechs industry in Norway. New Risk • May 27
New major risk - Share price stability The company's share price has been highly volatile over the past 3 months. It is more volatile than 90% of Norwegian stocks, typically moving 14% a week. This is considered a major risk. Share price volatility increases the risk of potential losses in the short-term as the stock tends to have larger drops in price more frequently than other stocks. It may also indicate the stock is highly sensitive to market conditions or economic conditions rather than being sensitive to its own business performance, which may also be inconsistent. Currently, the following risks have been identified for the company: Major Risks Share price has been highly volatile over the past 3 months (14% 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. Minor Risk Market cap is less than US$100m (kr627.3m market cap, or US$61.8m). Annuncio • 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. Reported Earnings • May 05
Full year 2024 earnings: EPS and revenues exceed analyst expectations Full year 2024 results: US$0.12 loss per share (further deteriorated from US$0.12 loss in FY 2023). Net loss: US$38.8m (loss widened 10% from FY 2023). Revenue exceeded analyst estimates by 172%. Earnings per share (EPS) also surpassed analyst estimates by 24%. Revenue is expected to fall by 114% p.a. on average during the next 3 years compared to a 32% decline forecast for the Biotechs industry in Norway. Over the last 3 years on average, earnings per share has fallen by 28% per year but the company’s share price has fallen by 56% per year, which means it is performing significantly worse than earnings. New Risk • May 05
New major risk - Dividend sustainability The dividend is not well covered by earnings and cash flows. The company is paying a dividend despite being loss-making. The company is paying a dividend despite having no free cash flows. Dividend yield: 37% This is considered a major risk. Companies that pay out too much of their earnings and cash flows are at risk of having to reduce or cut their dividend in future. If earnings or cash flows stagnate or fall, then there may not be enough to maintain the same dividend. Or in extreme cases, companies may opt to dig into capital reserves or take on debt to maintain the dividend. For dividend paying companies, any reduction in the dividend can significantly impact the share price. Currently, the following risks have been identified for the company: Major Risk 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. Minor Risks Share price has been volatile over the past 3 months (11% average weekly change). Market cap is less than US$100m (kr805.3m market cap, or US$77.4m). Annuncio • Apr 23
Nykode Therapeutics AS announces Annual dividend Nykode Therapeutics AS announced Annual dividend of NOK 1.0000 per share, ex-date on May 27, 2025 and record date on May 28, 2025. Major Estimate Revision • Apr 16
Consensus EPS estimates fall by 10% The consensus outlook for fiscal year 2025 has been updated. 2025 expected loss increased from -US$0.084 to -US$0.092 per share. Revenue forecast of US$300.0k unchanged since last update. Biotechs industry in Norway expected to see average net income growth of 8.9% next year. Consensus price target of kr6.75 unchanged from last update. Share price rose 12% to kr2.41 over the past week. Major Estimate Revision • Apr 08
Consensus revenue estimates decrease by 84% The consensus outlook for fiscal year 2025 has been updated. 2025 revenue forecast fell from US$1.78m to US$290.0k. EPS estimate unchanged at -US$0.081 per share. Biotechs industry in Norway expected to see average net income growth of 7.9% next year. Consensus price target of kr6.75 unchanged from last update. Share price was steady at kr2.14 over the past week. Major Estimate Revision • Mar 30
Consensus revenue estimates fall by 44% The consensus outlook for revenues in fiscal year 2025 has deteriorated. 2025 revenue forecast decreased from US$360.0k to US$200.0k. Forecast losses increased from -US$0.082 to -US$0.086 per share. Biotechs industry in Norway expected to see average net income growth of 7.9% next year. Consensus price target of kr12.83 unchanged from last update. Share price was steady at kr2.29 over the past week. Major Estimate Revision • Mar 23
Consensus EPS estimates fall by 15% The consensus outlook for fiscal year 2025 has been updated. 2025 expected loss increased from -US$0.081 to -US$0.094 per share. Revenue forecast of US$354.7k unchanged since last update. Biotechs industry in Norway expected to see average net income growth of 40% next year. Consensus price target of kr10.63 unchanged from last update. Share price rose 6.4% to kr2.30 over the past week. Major Estimate Revision • Mar 05
Consensus revenue estimates decrease by 46%, EPS upgraded The consensus outlook for fiscal year 2025 has been updated. 2025 revenue forecast fell from US$3.72m to US$2.00m. EPS estimate increased from -US$0.093 to -US$0.07 per share. Biotechs industry in Norway expected to see average net income growth of 24% next year. Consensus price target of kr10.63 unchanged from last update. Share price fell 17% to kr2.15 over the past week. Annuncio • Feb 28
Nykode Therapeutics ASA Announces Preclinical Data Highlighting its Immune Tolerance Platform's Ability to Modulate Multiple Key Immune Components in Autoimmune Disease Nykode Therapeutics ASA announced new preclinical findings reinforcing the unique mechanism of action and potential of its APC-targeted immune therapy platform in treating autoimmune diseases. Important new data show that Nykode's APC-targeted constructs increase antigen-specific regulatory T cells, which are known to downregulate an unwanted immune response, while simultaneously reducing antigen-specific effector T cells that drive inflammation. Furthermore, new data show that Nykodes's APC-targeted construct can reduce the generation of antigen-specific IgG autoantibodies, thereby shaping also the humoral component of the immune response, which is known to be involved in many autoimmune conditions. These changes suggest that the therapy works effectively through multiple arms of the antigen-specific immune system to promote its effectiveness and support its potential as a future therapy for autoimmune disorders, allergy and organ transplant rejection. Furthermore, new data show the data have been generated using MOG and PLP-1 antigens, which are applicable in chronic and relapsing-remitting EAE models. The Company remains committed to advancing its immune tolerance platform and further exploring the clinical potential of APC-targeted therapy for autoimmune diseases, allergies, and organ transplant rejection. Reported Earnings • Feb 27
Full year 2024 earnings: EPS and revenues exceed analyst expectations Full year 2024 results: US$0.12 loss per share (further deteriorated from US$0.12 loss in FY 2023). Net loss: US$38.8m (loss widened 10% from FY 2023). Revenue exceeded analyst estimates by 172%. Earnings per share (EPS) also surpassed analyst estimates by 23%. Revenue is forecast to grow 35% p.a. on average during the next 3 years, compared to a 31% growth forecast for the Biotechs industry in Norway. Over the last 3 years on average, earnings per share has fallen by 28% per year but the company’s share price has fallen by 61% per year, which means it is performing significantly worse than earnings. Major Estimate Revision • Jan 10
Consensus revenue estimates decrease by 17%, EPS upgraded The consensus outlook for fiscal year 2024 has been updated. 2024 revenue forecast fell from US$3.90m to US$3.24m. EPS estimate increased from -US$0.155 to -US$0.152 per share. Biotechs industry in Norway expected to see average net income growth of 7.4% next year. Consensus price target down from kr11.50 to kr10.63. Share price fell 8.8% to kr2.76 over the past week. Annuncio • Jan 08
Nykode Therapeutics ASA Announces Publication of Phase 2 VB-C-02 Data Confirming Prolonged Benefit and Definitive Vaccination Effects Nykode Therapeutics ASA announced the publication of a manuscript entitled Safety and efficacy of the therapeutic DNA- based vaccine VB10.16 in combination with atezolizumab in persistent, recurrent or metastatic HPV16- positive cervical cancer: a multicenter, single-arm phase 2a study in the peer-reviewed BMJ "Journal for ImmunoTherapy of Cancer" (JITC). The trial investigated the use of Nykode's wholly owned off-the- shelf therapeutic cancer vaccine candidate VB10.16 in combination with Roche's checkpoint inhibitor atezolizumab in patients with persistent and recurrent or metastatic HPV16-positive cervical cancer. As previously communicated, the published results confirm prolonged clinical benefits and indicate a potential synergistic treatment effect of VB10.16 in combination with atezolizumab compared to what has previously been reported for checkpoint inhibitor monotherapy. In this analysis the remaining patients were followed for up to 24 months, compared to at least 12 months in the previously reported data cut-off. The trial demonstrated an ORR of 19.1% in the efficacy population. With the extended 12-month follow- up period to the end of the trial, both mPFS and mOS increased compared to what has previously been reported, reaching 4.3 months and 21.3 months, respectively. In the subpopulation of PD-L1-positive patients (n=24) the ORR increased to 29.2% resulting in further improved mPFS and mOS of 6.3 months and 24.7 months, respectively. Among PD-L1-positive patients with one prior line of SATC (n=15), the ORR increased to 40.0%, and mPFS and mOS further improved to 15.8 months and not reached, respectively. VB-C-02 is a multi-center, single arm, open-label Phase 2 trial to assess the efficacy, immunogenicity and safety of VB10.16 in combination with the PD-L1 inhibitor atezolizumab in patients with advanced or recurrent, non-resectable human papillomavirus type 16 (HPV16)-positive cervical cancer. Patients received treatment with VB10.16 in combination with atezolizumab for up to one year. The trial enrolled 52 patients at sites in Europe. Additional information about the VB-C-02 trial is available at clinicaltrials.gov (NCT04405349). VB10.16 is a potentially first-in-class off-the-shelf therapeutic DNA-based cancer vaccine candidate in development for the treatment of HPV16-positive cancers. The cancer vaccine is designed based on Nykode's VaccibodyTM technology platform of targeting antigens to antigen presenting cells. VB10.16 has reported promising data from a Phase 2 trial in advanced PD-L1 positive cervical cancer patients (NCT04405349) in combination with atezolizumab The candidate has also demonstrated favorable clinical data in a Phase 1/2a study in pre-cancerous HPV16-induced high grade cervical intraepithelial neoplasia (HSIL; CIN 2/3) demonstrating a statistically significant correlation of immune responses and clinical responses. Nykode is currently investigating VB10.16 in VB-C-03, an open-label, dose-finding Phase 1/2a trial evaluating VB10.16 in combination with MSD's PD-L1 inhibitor KEYTRUDA® (pembrolizumab) in patients with HPV16-positive, PD-L1-positive, recurrent, or metastatic head and neck squamous cell carcinoma (HNSCC). Cervical cancer is the fourth leading cause of cancer death in women worldwide and is most frequently diagnosed between the ages of 35 and 44. Each year around 600,000 women are diagnosed with cervical cancer worldwide. Almost all cases are caused by human papillomavirus (HPV) infection and HPV16 accounts for more than half of all cervical cancer cases. Approximately 80% of patients with cervical cancer have squamous cell carcinoma and most other patients have adenocarcinomas. Cervical cancer is often curable when detected early and effectively managed, but treatment options are more limited in advanced disease stages or when the cancer has spread. One of the emerging challenges within oncology is the virus-induced cancer types, with Human Papillomavirus (HPV) being one of the most prominent. There are several types of high-risk HPV causing cancers, HPV16 being one of the most common, with more than 130,000 new cases in the U.S. and EU per year. Using a therapeutic cancer vaccine targeted specifically towards the HPV16 infected cells in the tumors, such as Nykode's cancer vaccine VB10.16, represents a novel immunotherapeutic treatment option. By combining a therapeutic cancer vaccine with the checkpoint inhibitors and/or other general immune therapies, the tumors can be attacked by the cancer-specific T cells from several angles with the aim of improving patient outcomes. Annuncio • Jan 01
Nykode Therapeutics AS, Annual General Meeting, May 22, 2025 Nykode Therapeutics AS, Annual General Meeting, May 22, 2025. Recent Insider Transactions • Dec 24
Director recently sold kr300k worth of stock On the 20th of December, Christian Åbyholm sold around 100k shares on-market at roughly kr3.00 per share. This transaction amounted to 100% of their direct individual holding at the time of the trade. This was the largest sale by an insider in the last 3 months. Despite this recent sale, insiders have collectively bought kr2.2m more than they sold in the last 12 months. Major Estimate Revision • Dec 04
Consensus revenue estimates fall by 35% The consensus outlook for revenues in fiscal year 2024 has deteriorated. 2024 revenue forecast decreased from US$6.41m to US$4.17m. Forecast losses increased from -US$0.148 to -US$0.16 per share. Biotechs industry in Norway expected to see average net income decline 16% next year. Consensus price target of kr11.50 unchanged from last update. Share price was steady at kr2.83 over the past week. Reported Earnings • Nov 28
Third quarter 2024 earnings: EPS exceeds analyst expectations while revenues lag behind Third quarter 2024 results: US$0.03 loss per share (in line with 3Q 2023). Net loss: US$9.73m (loss narrowed 5.0% from 3Q 2023). Revenue missed analyst estimates by 77%. Earnings per share (EPS) exceeded analyst estimates by 29%. Revenue is forecast to grow 33% p.a. on average during the next 3 years, compared to a 51% growth forecast for the Biotechs industry in Norway. Over the last 3 years on average, the company's share price growth rate has exceeded its earnings growth rate by 12 percentage points per year, which is a significant difference in performance. Price Target Changed • Nov 27
Price target decreased by 19% to kr17.75 Down from kr22.00, the current price target is an average from 4 analysts. New target price is 527% above last closing price of kr2.83. Stock is down 84% over the past year. The company is forecast to post a net loss per share of US$0.15 next year compared to a net loss per share of US$0.12 last year. Price Target Changed • Nov 21
Price target decreased by 21% to kr22.00 Down from kr27.75, the current price target is an average from 4 analysts. New target price is 700% above last closing price of kr2.75. Stock is down 87% over the past year. The company is forecast to post a net loss per share of US$0.15 next year compared to a net loss per share of US$0.12 last year. New Risk • Nov 09
New minor risk - Market cap size The company's market capitalization is less than US$100m. Market cap: kr783.7m (US$71.2m) 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 (20% average weekly change). Earnings are forecast to decline by an average of 21% per year for the foreseeable future. Minor Risk Market cap is less than US$100m (kr783.7m market cap, or US$71.2m). Annuncio • Nov 07
Nykode Therapeutics ASA Announces Updates on its Inverse Vaccine Platform at Pegs Europe Nykode Therapeutics ASA announced new findings related to its APC-targeted inverse vaccine platform's efficacy in treating autoimmune disease at the annual PEGS Europe conference in Barcelona. The data presented emphasize the role of antigen-presenting cell (APC) targeting in achieving therapeutic effectiveness, particularly in Experimental Autoimmune Encephalomyelitis (EAE), a mouse model of human multiple sclerosis (MS). Findings from both therapeutic and preventive applications support the platform's potential in providing targeted, effective treatment for MS, an autoimmune disease that affects approximately 2.8 million people worldwide, with a high annual economic burden and a significant unmet medical need for new treatments. Nykode's latest data confirm that APC targeting by the inverse vaccine is essential for achieving effective therapeutic outcomes, demonstrating superior efficacy over a non-targeted vaccine or antigen alone. When applied therapeutically, a new version of Nykode's inverse vaccine provides robust disease protection in a relapsing-remitting EAE model which better reflect the relapsing-remitting disease in human MS. This result builds upon prior findings and includes efficacy of an alternative central nervous system autoantigen, broadening the inverse vaccine's potential applicability in MS treatment. Aligned with these outcomes, mice treated with the Nykode inverse vaccine exhibit a marked reduction in disease-associated inflammatory cytokine release following disease induction. This reduction aligns with mitigated disease severity and inflammation, highlighting the therapeutic potential of the Nykode inverse vaccine in immune disorders. Major Estimate Revision • Sep 12
Consensus revenue estimates decrease by 19% The consensus outlook for fiscal year 2024 has been updated. 2024 revenue forecast fell from US$8.61m to US$7.01m. EPS estimate reaffirmed at -US$0.15 per share. Biotechs industry in Norway expected to see average net income decline 7.1% next year. Consensus price target down from kr27.75 to kr25.75. Share price fell 7.9% to kr5.25 over the past week. Price Target Changed • Aug 29
Price target decreased by 20% to kr29.13 Down from kr36.63, the current price target is an average from 4 analysts. New target price is 341% above last closing price of kr6.60. Stock is down 77% over the past year. The company is forecast to post a net loss per share of US$0.16 next year compared to a net loss per share of US$0.12 last year. Major Estimate Revision • Aug 28
Consensus revenue estimates decrease by 54%, EPS upgraded The consensus outlook for fiscal year 2024 has been updated. 2024 revenue forecast fell from US$11.8m to US$5.40m. EPS estimate increased from -US$0.186 to -US$0.143 per share. Biotechs industry in Norway expected to see average net income growth of 33% next year. Consensus price target down from kr36.63 to kr34.13. Share price rose 24% to kr6.90 over the past week. Recent Insider Transactions • Aug 23
Chairman of the Board recently bought kr283k worth of stock On the 21st of August, Alf Gunnar Nicklasson bought around 50k shares on-market at roughly kr5.65 per share. This transaction amounted to 54% of their direct individual holding at the time of the trade. This was the largest purchase by an insider in the last 3 months. Alf Gunnar has been a buyer over the last 12 months, purchasing a net total of kr835k worth in shares. Reported Earnings • Aug 22
Second quarter 2024 earnings: EPS exceeds analyst expectations while revenues lag behind Second quarter 2024 results: US$0.02 loss per share (improved from US$0.03 loss in 2Q 2023). Net loss: US$7.39m (loss narrowed 20% from 2Q 2023). Revenue missed analyst estimates by 82%. Earnings per share (EPS) exceeded analyst estimates by 57%. Revenue is forecast to grow 30% p.a. on average during the next 3 years, compared to a 40% growth forecast for the Biotechs industry in Norway. Over the last 3 years on average, the company's share price growth rate has exceeded its earnings growth rate by 47 percentage points per year, which is a significant difference in performance. New Risk • Jul 29
New minor risk - Share price stability The company's share price has been volatile over the past 3 months. It is more volatile than 75% of Norwegian stocks, typically moving 6.6% a week. This is considered a minor risk. Share price volatility indicates the stock is highly sensitive to market conditions or economic conditions rather than being sensitive to its own business performance, which may also be inconsistent. It also increases the risk of potential losses in the short term as the stock tends to have larger drops in price more frequently than other stocks. Currently, the following risks have been identified for the company: Major Risk Earnings are forecast to decline by an average of 18% per year for the foreseeable future. Minor Risks Share price has been volatile over the past 3 months (6.6% average weekly change). Shareholders have been diluted in the past year (11% increase in shares outstanding). Annuncio • Jun 20
Nykode Therapeutics Announces Updates on its Inverse Vaccine Platform at FOCIS 2024 Meeting Nykode Therapeutics ASA announced advancements in its inverse vaccine platform at the annual Federation of Clinical Immunology Societies (FOCIS) meeting in San Francisco. Building on findings previously announced in March at the Antigen-Specific Immune Tolerance Summit in Boston, Nykode presented extended therapeutic data from the experimental autoimmune encephalomyelitis (EAE) model of Multiple Sclerosis (MS). The updates included demonstrating the disease-modifying effects of two distinct targeting units within its inverse vaccine platform in a therapeutic regimen, highlighting the versatility and effectiveness of antigen-presenting cell (APC)-targeting strategies. At the conference, Nykode presented data, demonstrating a dose-dependent and disease-modifying effect of its antigen-specific APC-targeting vaccine in a therapeutic regimen, compared to the delivery of antigen alone, emphasizing the platform’s potential for effective antigen-specific treatment for autoimmune disorders. There are approximately 100 different autoimmune diseases affecting about 4% of the world population, representing a significant unmet medical need for novel treatments. Nykode is focusing on developing antigen-specific treatments for autoimmune diseases by using its APC-targeting platform to deliver a tolerogenic response towards disease-associated antigens. Major Estimate Revision • May 29
Consensus revenue estimates decrease by 35%, EPS upgraded The consensus outlook for fiscal year 2024 has been updated. 2024 revenue forecast fell from US$20.4m to US$13.3m. EPS estimate increased from -US$0.206 to -US$0.178 per share. Biotechs industry in Norway expected to see average net income growth of 28% next year. Consensus price target of kr43.00 unchanged from last update. Share price rose 3.5% to kr15.01 over the past week. Major Estimate Revision • May 21
Consensus revenue estimates increase by 37%, EPS downgraded The consensus outlook for fiscal year 2024 has been updated. 2024 revenue forecast increased from US$14.6m to US$20.0m. EPS estimate fell from -US$0.174 to -US$0.202 per share. Biotechs industry in Norway expected to see average net income decline 2.2% next year. Consensus price target of kr43.00 unchanged from last update. Share price rose 2.2% to kr14.67 over the past week. Reported Earnings • May 16
First quarter 2024 earnings: EPS and revenues miss analyst expectations First quarter 2024 results: US$0.05 loss per share (further deteriorated from US$0.04 loss in 1Q 2023). Revenue: US$1.02m (down 69% from 1Q 2023). Net loss: US$14.9m (loss widened 44% from 1Q 2023). Revenue missed analyst estimates by 84%. Earnings per share (EPS) also missed analyst estimates by 1.9%. Revenue is forecast to grow 34% p.a. on average during the next 3 years, compared to a 34% growth forecast for the Biotechs industry in Norway. Over the last 3 years on average, the company's share price growth rate has exceeded its earnings growth rate by 72 percentage points per year, which is a significant difference in performance. Reported Earnings • Apr 22
Full year 2023 earnings: EPS and revenues exceed analyst expectations Full year 2023 results: US$0.12 loss per share (improved from US$0.15 loss in FY 2022). Revenue: US$13.3m (up 48% from FY 2022). Net loss: US$35.2m (loss narrowed 18% from FY 2022). Products in clinical trials Phase I: 2 Phase II: 7 Revenue exceeded analyst estimates by 16%. Earnings per share (EPS) also surpassed analyst estimates by 27%. Revenue is forecast to grow 31% p.a. on average during the next 3 years, compared to a 33% growth forecast for the Biotechs industry in Norway. Over the last 3 years on average, the company's share price growth rate has exceeded its earnings growth rate by 71 percentage points per year, which is a significant difference in performance. Annuncio • Apr 20
Nykode Therapeutics ASA Initiates Phase 2 Trial of VB10.16 in Second Line HPV16-Positive Cervical Cancer Nykode Therapeutics ASA announced the initiation of the Phase 2 clinical trial VB-C-04. The trial evaluates VB10.16, the company’s off-the-shelf therapeutic cancer vaccine candidate for HPV16-positive cancers, alone or in combination with Roche’s checkpoint inhibitor atezolizumab (Tecentriq®1) in patients with HPV16-positive, PD-L1-positive, recurrent, or metastatic cervical cancer. Step 1 of VB-C-04 is a two-arm Phase 2 trial evaluating the efficacy and safety of VB10.16 alone or in combination with atezolizumab in patients with recurrent or metastatic cervical cancer refractory to first-line treatment with pembrolizumab plus chemotherapy +/- bevacizumab. The Phase 2 trial (GOG-3091) will be conducted in the United States (U.S.) in collaboration with The GOG Foundation Inc. (GOG Foundation), a U.S. based not-for-profit organization with the purpose of promoting excellence in the quality and integrity in clinical trials in gynecologic malignancies. The GOG Foundation is the only clinical trialist group in the United States that focuses its research on patients with pelvic malignancies, such as cancer of the ovary (including surface peritoneal malignancies), uterus (including endometrium, soft tissue sarcoma, and gestational trophoblastic neoplasia), cervix, and vulva. Atezolizumab is supplied by Roche. Nykode retains all commercial rights to VB10.16 worldwide. Recent Insider Transactions • Mar 27
Director recently bought kr310k worth of stock On the 21st of March, Birgitte Volck bought around 20k shares on-market at roughly kr15.28 per share. This trade did not impact their existing holding. In the last 3 months, there was an even bigger purchase from another insider worth kr552k. Insiders have collectively bought kr1.7m more in shares than they have sold in the last 12 months. Annuncio • Mar 22
Nykode Therapeutics Announces Topline Conclusions Affirming Prolonged Clinical Benefits from Matured Survival Data in Phase 2 C-02 Trial in Advanced Cervical Cancer Nykode Therapeutics ASA announced key conclusions from the updated analysis from the Phase 2 VB-C-02 trial. The trial investigates the use of Nykode's wholly-owned off-the-shelf therapeutic cancer vaccine candidate VB10.16 in combination with Roche's checkpoint inhibitor atezolizumab in patients with recurrent or metastatic HPV16-positive cervical cancer. The updated results, which closely mirror the previously reported positive C-02 outcomes, affirm prolonged benefits and indicate a synergistic treatment effect of VB10.16 plus atezolizumab compared to the historical controls of monotherapy with checkpoint inhibitors. The updated analysis' observation time for the remaining patients was at least 24 months, compared to at least 12 months at the previously reported outcome. Nykode has a focused strategy to develop VB10.16, including a potentially US registrational trial C-04 in recurrent/metastatic cervical cancer and a C-03 trial in first-line head and neck cancer, two areas with a high unmet medical need. The company is also planning to move VB10.16 into early-stage cervical cancer. Nykode is committed to advancing the field of immunotherapy and sharing its research findings with the broader scientific community in line with their publication guidelines. To this end, the company will present the detailed data from the Phase 2 VB -C-02 trial in a future scientific publication and at a forthcoming medical conference. Nykode wishes to thank the patients, their families and the investigators for their participation and contribution to the VB-C-02 trials. VB-C-02 is a multi-center, single arm, open-label Phase 2 trial to assess the efficacy, immunogenicity and safety of VB10.16 in collaboration with the PD-L1 inhibitor atezolizum AB in patients with advanced or recurrent, non-resectable HPV16-positive cervical cancer; Patients received treatment with VB10.16 in combined with Roche's checkpoint inhibitor atezolizumab for up to one year. The cancer vaccine is designed based on Nykode's Vaccibody technology platform of targeting antigens to antigen presenting cells. VB10.16 has reported promising data from a Phase 2 trial in advanced PD-L1 positive cervical cancer patients (NCT04405349) in combination with atezolizumab with mOS not reached, but greater than 25 months at the time of analysis. The vaccine-induced significant HPV16-specific T cell responses that were correlated with clinical responses. The candidate has also demonstrated favorable clinical data in a Phase 1/2a study in pre-cancerousHPV16-induced high grade cervical intraepithelial neoplasia (HSIL; CIN 2/3) demonstrating a statistically significant correlation of immune responses and clinical responses. Nykode is currently investigating VB10.16 in VB-C-03, an open-label, dose-finding Phase 1/2a trial evaluating VB 10.16 in combination with MSD's PD-1 inhibitor KEYTRUDA®? (pembrolizumab) in patients with HPV16-positive, PD-L1-positive, recurrent, or metastatic head and neck squ squ squ squ squatatatatatat. Annuncio • Mar 20
Nykode Therapeutics ASA Announces Advances in the Inverse Vaccine Platform with the Potential to Treat Autoimmune Diseases Nykode Therapeutics ASA announced key updates of the inverse vaccine platform with the potential to treat autoimmune diseases at the 7th Antigen-Specific Immune Tolerance Drug Development Summit in Boston. Nykode employs its unique technology platform to pioneer the field of inverse vaccines, with the potential to develop high-precision treatments for autoimmune diseases. At the conference, Nykode demonstrated for the first time a significant effect in a therapeutic setting in a preclinical model for Multiple Sclerosis (MS) with its inverse vaccine platform. The data also illustrate the strong contribution of the specific targeting unit and confirm that the disease protection is antigen-specific, underscoring the potential of Nykode’s technology in the field of autoimmune diseases. During its Capital Markets Day in New York in September last year, Nykode announced that its inverse vaccine platform had prevented serious disease in models of MS and type 1 diabetes in mice, showcasing the technology's broad disease-modifying potential in an antigen-specific manner. Notably, the efficacy was enhanced with the integration of Nykode's 4th Module technology, emphasizing its role in modulating the immune response to amplify therapeutic effects. Price Target Changed • Mar 13
Price target decreased by 36% to kr43.00 Down from kr67.00, the current price target is an average from 3 analysts. New target price is 186% above last closing price of kr15.01. Stock is down 33% over the past year. The company is forecast to post a net loss per share of US$0.18 next year compared to a net loss per share of US$0.12 last year. Major Estimate Revision • Mar 13
Consensus EPS estimates upgraded to US$0.18 loss The consensus outlook for fiscal year 2024 has been updated. 2024 losses forecast to reduce from -US$0.201 to -US$0.177 per share. Revenue forecast unchanged from US$25.2m at last update. Biotechs industry in Norway expected to see average net income growth of 14% next year. Consensus price target of kr43.00 unchanged from last update. Share price was steady at kr15.01 over the past week. Recent Insider Transactions • Mar 03
Chief Executive Officer recently bought kr100k worth of stock On the 29th of February, Michael Engsig bought around 6k shares on-market at roughly kr16.71 per share. This transaction amounted to 61% of their direct individual holding at the time of the trade. This was the largest purchase by an insider in the last 3 months. This was Michael's only on-market trade for the last 12 months. Reported Earnings • Mar 01
Full year 2023 earnings: EPS and revenues exceed analyst expectations Full year 2023 results: US$0.12 loss per share (improved from US$0.15 loss in FY 2022). Revenue: US$13.3m (up 48% from FY 2022). Net loss: US$35.2m (loss narrowed 18% from FY 2022). Revenue exceeded analyst estimates by 16%. Earnings per share (EPS) also surpassed analyst estimates by 27%. Revenue is forecast to grow 31% p.a. on average during the next 3 years, compared to a 33% growth forecast for the Biotechs industry in Norway. Over the last 3 years on average, the company's share price growth rate has exceeded its earnings growth rate by 75 percentage points per year, which is a significant difference in performance. Annuncio • Dec 21
Nykode Therapeutics AS, Annual General Meeting, May 16, 2024 Nykode Therapeutics AS, Annual General Meeting, May 16, 2024. Annuncio • Dec 14
Nykode Therapeutics Announces Expansion of Oncology Pipeline Aiming to Reduce the Burden of Colorectal Cancer Nykode Therapeutics ASA announced an expansion of the pipeline with a potential first-in-class preclinical oncology vaccine program aimed at preventing and treating colorectal cancer. Colorectal cancer begins as a premalignant polyp that grows on the mucosal surface of the colon or rectum and transforms into malignancy. The disease development and screening programs represent an opportunity to identify and treat high-risk patients at early stages in addition to treating patients with developed malignancies. Nykode's novel vaccines are based on a careful selection and combination of highly expressed tumor associated antigens involved in the development and progression of colonic polyps to colorectal cancer. The program will incorporate Nykode's 4th module proprietary second-generation technology to further optimize the immune responses tailored to diverse target populations. The program builds on Nykode's differentiating competence of creating broad and robust CD8 T cell responses with the potential to break tolerance against tumor-associated antigens, as illustrated by data presented at Nykode's recent Capital Market Day. Strong preclinical data generated in the discovery phase further supports the induction of potent CD8 T cell responses in both wild-type and HLA transgenic mice models. Reported Earnings • Nov 17
Third quarter 2023 earnings released: US$0.03 loss per share (vs US$0.05 loss in 3Q 2022) Third quarter 2023 results: US$0.03 loss per share (improved from US$0.05 loss in 3Q 2022). Revenue: US$2.81m (up 119% from 3Q 2022). Net loss: US$10.2m (loss narrowed 31% from 3Q 2022). Revenue is forecast to grow 22% p.a. on average during the next 3 years, compared to a 31% growth forecast for the Biotechs industry in Norway. Over the last 3 years on average, the company's share price growth rate has exceeded its earnings growth rate by 63 percentage points per year, which is a significant difference in performance. New Risk • Nov 06
New minor risk - Shareholder dilution The company's shareholders have been diluted in the past year. Increase in shares outstanding: 12% This is considered a minor risk. Shareholder dilution occurs when there is an increase in the number of shares on issue that is not proportionally distributed between all shareholders. Often due to the company raising equity capital or some options being converted into stock. All else being equal, if there are more shares outstanding then each existing share will be entitled to a lower proportion of the company's total earnings, thus reducing earnings per share (EPS). While dilution might not always result in lower EPS (like if the company is using the capital to fund an EPS accretive acquisition) in a lot cases it does, along with lower dividends per share and less voting power at shareholder meetings. Currently, the following risks have been identified for the company: Major Risk Earnings are forecast to decline by an average of 19% per year for the foreseeable future. Minor Risk Shareholders have been diluted in the past year (12% increase in shares outstanding). Annuncio • Oct 01
Nykode Therapeutics ASA Initiates Phase 1/2a Trial of VB10.16 in First Line HPV16-Positive Head and Neck Cancer Nykode Therapeutics ASA announced the initiation of the Phase 1/2a clinical trial. The trial evaluates VB10.16, the Company’s wholly owned off-the-shelf therapeutic cancer vaccine candidate for HPV16-positive cancers, in combination with MSD’s (Merck & Co., Rahway, NJ, USA) PD-1 inhibitor KEYTRUDA (pembrolizumab) in first line (1L) setting in patients with HPV16-positive, PD-L1-positive, recurrent or metastatic head and neck squamous cell carcinoma (HNSCC). VB-C-03 is a Phase 1/2a open-label, dose-finding trial investigating safety, tolerability, and efficacy. It consists of two consecutive phases, a dose escalation phase (Phase 1) and a dose expansion phase (Phase 2a), testing VB10.16 in doses up to 9 mg, in combination with pembrolizumab in a 1L setting in patients with HPV16-positive, PD-L1-positive HNSCC. The trial will take place in Europe. Merck will supply KEYTRUDA, while Nykode retains all commercial rights to VB10.16 worldwide. Annuncio • Sep 21
Nykode Therapeutics ASA Announces Advances in Clinical Pipeline and Research Nykode Therapeutics ASA announced significant advances in its clinical pipeline and research at the Capital Markets Day in New York. VB10.16: Therapeutic vaccine candidate for human papilloma virus (HPV) 16+ cancers with strong clinical data Additional VB-C-02 data supporting a differentiated long-lasting and clinically relevant immune response. VB-C-04 trial design: Potentially registrational phase 2 trial in recurrent/metastatic (R/M) cervical cancer progressing on 1st line standard of care (SOC) (pembrolizumab + chemotherapy +/- bevacizumab). IND approval received from FDA and on track to be initiated Fourth Quarter 2023. VB-C-03 trial design: Phase 1/2a trial. Combination treatment of VB10.16+pembrolizumab in 1st line HPV16+ R/M HNSCC. On track to be initiated in Third Quarter 2023. VB10.16 is Nykode’s wholly owned candidate for treatment of HPV16-driven cancer types. Nykode is presenting additional data from the VB-C-02 trial which strongly supports the generation of durable clinically relevant T cell responses. The evidence includes the formation of multiple and enduring T cell clones post-vaccination and significant changes in blood cell composition. A robust correlation observed between HPV16 circulating tumor DNA and clinical outcomes. This correlation is discernible from the first measured post-vaccination timepoint which supports further exploration of HPV16 circulating tumor DNA as an early predictor of clinical outcome. Nykode has received FDA approval for its potentially registrational VB-C-04 trial, which is on track to initiate in the fourth quarter of the year. The trial builds on the positive data from the VB-C-02 trial indicating differentiated and durable anti-tumor responses. The VB-C-04 trial plans to enroll 130 patients with recurrent or metastatic cervical cancer, who have previously undergone first-line standard of care treatment (comprising pembrolizumab, chemotherapy, and optionally, bevacizumab). Part A of the trial will involve a randomized allocation of 30 patients each to receive either VB10.16 in combination with Atezolizumab or VB10.16 monotherapy. After an interim analysis, the superior treatment arm will be expanded to include an additional 70 patients. Nykode is expanding into first-line treatment for PD-L1-positive patients with head and neck cancer and has secured all the necessary regulatory approvals to initiate the VB-C-03 trial. VB10.NEO: pioneering neoantigen research Vaccine-specific T cells remain functional and immunogenic up to 1-year after last vaccination. Multiple vaccinations boost the breadth and magnitude of functional T cell responses. In-depth analysis of data stemming from Nykode’s fully personalized neoantigen trial, VB-N-01, has yielded encouraging results. Enduring immune responses to the vaccine neoantigens have been observed, persisting for at least one year following the administration of the last dose of VB10.NEO. This evidence reaffirms the ability to generate long-lasting T cell responses. VB10.NEO is exclusively outlicensed to Genentech, a member of the Roche Group. The VB-N-01 trial was conducted by Nykode prior to the outlicensing of VB.10.NEO to Genentech. Future cancer vaccines: De-risked through partnerships Regeneron partnership: All five programs initiated and advancing, with multiple preclinical vaccine candidates designed for each program. Nykode vaccine shows potential to induce potent T cell responses against self-antigens with various degrees of central tolerance. Next step involves selecting lead candidates for further development. Nykode’s partnership with Regeneron continues to make significant progress, with the process of lead selection moving forward. In addition to the development of preclinical candidates, Regeneron has explored Nykode’s vaccine platform's capacity to elicit T cell responses against germline-encoded tumor-associated antigens (self-antigens). The data demonstrates the possibility of the Nykode vaccine platform to overcome tolerance to various tumor-associated self-antigens that are characterized by low/no thymic expression, which may not be subject to central tolerance. These tumor-associated self-antigens include genes commonly overexpressed in tumor tissues and often prevalent among larger patient populations but with no expression in normal, healthy tissue. These promising findings exemplifies some of the many possibilities in Nykode’s future vaccine development endeavors beyond viral and individualized neoantigens. Advancements in Autoimmunity Nykode is leveraging its antigen presenting cells (APC)-targeted technology in a first-in-class approach to pursue treatments for autoimmune diseases. New data shows that Nykode vaccines targeting tolerogenic dendritic cells prevents serious disease in a Multiple Sclerosis (MS)-like mouse disease model. Disease-preventing effect demonstrated using different APC-targeting units. Additionally, Nykode vaccine targeting tolerogenic DCs shows efficacy in a spontaneous type 1 diabetes mouse model. Nykode’s 4th Module technology is found to further amplify the effect. its results demonstrate the technology's disease modifying potential in autoimmune disorders, as evidenced in models of both multiple sclerosis- and diabetes. This breakthrough presents a substantial additional potential commercial opportunity for Nykode, reinforcing its position as industry frontrunner. The data showed therapeutic effects with various APC-targeting units and both protein and plasmid DNA delivery methods. Interestingly, the addition of Nykode’s proprietary 4th module technology demonstrated potential to further improve the efficacy. Nykode has made a strategic commitment to intensify its efforts and has established a dedicated autoimmunity research group to drive optimal progress in this new and promising opportunity area. Annuncio • Sep 06
Nykode Therapeutics ASA Announces FDA Approval of IND for VB-C-04, a Trial of VB-C-04 in HPV16-Positive Cervical Cancer Nykode Therapeutics ASA announced FDA approval of its investigational new drug (IND) application for the Phase 2 clinical trial. The trial is designed to evaluate VB10.16, the company's wholly owned off-the-shelf therapeutic cancer vaccine candidate for HPV16-positive cancers, in combination with Roche's PD-L1 inhibitor atezolizumab (Tecentriq®1) in patients with HPV16-positive, PD-L1-positive, recurrent or metastatic cervical cancer. Nykode is on track to initiate the trial in the fourth quarter of 2023. Atezolizumab is supplied by Roche. Nykode retains all commercial rights to VB10.16 worldwide. Reported Earnings • Aug 23
Second quarter 2023 earnings: EPS and revenues exceed analyst expectations Second quarter 2023 results: US$0.03 loss per share (in line with 2Q 2022). Revenue: US$5.10m (up 49% from 2Q 2022). Net loss: US$9.21m (loss widened 5.3% from 2Q 2022). Revenue exceeded analyst estimates significantly. Earnings per share (EPS) also surpassed analyst estimates by 36%. Revenue is expected to decline by 15% p.a. on average during the next 3 years, while revenues in the Biotechs industry in Norway are expected to grow by 11%. Over the last 3 years on average, the company's share price growth rate has exceeded its earnings growth rate by 60 percentage points per year, which is a significant difference in performance. Annuncio • Jun 02
Nykode Therapeutics Announces Expansion of Clinical Collaboration with Roche to Evaluate VB10.16 in Combination with anti-PD-L1 in the Next Trial in Advanced Cervical Cancer Nykode Therapeutics ASA announced that it has expanded the clinical collaboration and supply agreement with Roche to cover evaluation of VB10.16, Nykode's wholly owned off-the-shelf therapeutic cancer vaccine candidate, in combination with Roche's cancer immunotherapy atezolizumab in patients with advanced cervical cancer who have progressed on pembrolizumab plus chemotherapy +/- bevacizumab as first line treatment. The VB-C-04 trial is expected to be initiated in the U.S. in the fourth quarter of 2023 with registrational intent, which provides a potential fast-to-market path. Under the terms of the agreement, Nykode will sponsor and fund the planned clinical trial, and Roche will provide atezolizumab. Nykode retains all commercial rights to VB10.16 worldwide. Nykode has recently reported positive safety and efficacy results from the Phase 2 VB-C-02 trial in Europe in advanced cervical cancer patients with VB10.16 in combination with atezolizumab. The results showed an overall response rate (ORR) of 29%, median overall survival (mOS) not reached but greater than 25 months at the time of analysis, and 6.3 months median progression free survival (mPFS) in PD-L1+ patients. In the patient population most relevant for the upcoming VB-C-04 trial, PD-L1+ patients with one prior line of systemic treatment, ORR was 40% and disease control rate was 80% with mPFS of 16.9 months and mOS not reached but greater than 25 months at the time of analysis. The VB-C-04 trial will be conducted together with GOG Foundation, a U.S.-based not-for-profit organization with expertise in bringing best-in-class new treatments to patients. Annuncio • May 12
Nykode Therapeutics AS Announces Management Changes Nykode Therapeutics AS at its Annual General Meeting held on May 11, 2023, approved Harald Arnet as a new board member to replace Jan Haudemann-Andersen, who has decided to step down from the board and approved Lars Lund-Roland as Chairperson of the Nomination Committee. The former Chair of the Nomination Committee, Harald Arnet, will resign from the Nomination Committee, as he has been elected as a board member of the Company. Following this, the Nomination Committee consists of: Lars Lund-Roland, Chair of the Committee; Lars Erik Larsson and Jan Fikkan. Reported Earnings • Apr 20
Full year 2022 earnings: EPS in line with analyst expectations despite revenue beat Full year 2022 results: US$0.15 loss per share (further deteriorated from US$0.033 loss in FY 2021). Net loss: US$42.7m (loss widened 354% from FY 2021). Products in clinical trials Phase I: 3 Phase II: 6 Revenue exceeded analyst estimates by 68%. Earnings per share (EPS) were mostly in line with analyst estimates. Revenue is forecast to grow 4.2% p.a. on average during the next 3 years, compared to a 1.9% growth forecast for the Biotechs industry in Norway. Over the last 3 years on average, earnings per share has fallen by 17% per year but the company’s share price has increased by 10% per year, which means it is well ahead of earnings. Reported Earnings • Mar 01
Full year 2022 earnings released: US$0.15 loss per share (vs US$0.033 loss in FY 2021) Full year 2022 results: US$0.15 loss per share (further deteriorated from US$0.033 loss in FY 2021). Net loss: US$42.7m (loss widened 354% from FY 2021). Revenue is expected to fall by 18% p.a. on average during the next 2 years compared to a 35% decline forecast for the Biotechs industry in Norway. Over the last 3 years on average, earnings per share has fallen by 17% per year but the company’s share price has increased by 8% per year, which means it is well ahead of earnings. Recent Insider Transactions Derivative • Jan 27
Director exercised options and sold kr7.4m worth of stock On the 25th of January, Anders Tuv exercised 800.00k options at around kr2.50, then sold 475k of the shares acquired at an average of -kr13.05 per share and kept the remainder. As of today, Anders currently holds no shares directly. Company insiders have collectively bought kr8.5m more than they sold, via options and on-market transactions, in the last 12 months. Annuncio • Dec 20
Nykode Expands Clinical Development Plan for Its Lead Cancer Vaccine Vb10.16 in Hpv16-Positive Cancers Nykode Therapeutics ASA announced an expanded clinical development plan for VB10.16, the Company’s wholly-owned cancer vaccine, for the treatment of HPV16-positive cancers with high unmet need. Nykode Management will host a webcast, December 20, 2022, to discuss the development plan at 11 a.m. CET (in Norwegian) and 4 p.m. CET/10 a.m. ET (in English). VB10.16 is an off-the-shelf therapeutic cancer vaccine specifically designed to treat HPV16-induced malignancies. The drug candidate has reported interim data from VB-C-02, a Phase 2 trial in heavily pre-treated cervical cancer patients. The analysis demonstrated a favorable safety profile, with responses observed in both PD-L1 positive and negative patients (ORR 27% and 17%, respectively). The vaccine-induced significant HPV16-specific T cell responses that were associated with clinical responses. Cervical Cancer: Nykode is planning to conduct a single arm trial, VB-C-04, with potential registrational intent in 2nd line immune checkpoint inhibitor refractory advanced cervical cancer patients. The trial will be conducted in the United States and initiated in the fourth quarter of 2023. Head and Neck Cancer: Nykode is planning to conduct an open-label, dose-finding, single arm Phase 1b/2a trial of VB10.16 in combination with pembrolizumab in patients with first line HPV16-postive, recurrent or metastatic squamous cell head and neck cancer as described in Nykode’s announcement on December 6, 2022. The trial, VB-C-03, will evaluate the overall response rate, safety, tolerability, and antigen specific immune response of the combination therapies. Nykode expects to enroll patients in Europe during the first half of 2023. Basket Trial: Nykode expects to collaborate on an investigator-initiated basket trial to evaluate VB10.16 in combination with a PD-L1 inhibitor in patients diagnosed with HPV16-positive anal, penile, vaginal and/or vulvar cancer who are no longer eligible for curative treatments. The trial is expected to enroll patients with both PD-L1 positive and PD-L1 negative tumors. Nykode will continue to study VB10.16 in patients with PD-L1 negative tumors to investigate VB10.16’s potential for a dedicated trial in such a patient population. VB10.16 is a potentially first-in-class off-the-shelf therapeutic cancer vaccine candidate in development for the treatment of human papillomavirus type 16 (HPV16)-positive cancers. The cancer vaccine is designed based on Nykode’s Vaccibody™ technology platform of targeting antigens to antigen presenting cells. VB10.16 has reported positive interim data from a Phase 2 trial in heavily pre-treated cervical cancer patients (NCT04405349). The analysis demonstrated a favorable safety profile, with responses observed in both PD-L1 positive and negative patients (ORR 27% and 17%, respectively). The vaccine-induced significant HPV16-specific T cell responses were associated with clinical responses. The candidate has also demonstrated favorable clinical data in a Phase 1/2a study in pre-cancerous HPV16-induced high grade cervical intraepithelial neoplasia (HSIL; CIN 2/3) demonstrating a statistically significant correlation of immune responses and clinical responses. Reported Earnings • Nov 24
Third quarter 2022 earnings released: US$0.05 loss per share (vs US$0.03 loss in 3Q 2021) Third quarter 2022 results: US$0.05 loss per share (further deteriorated from US$0.03 loss in 3Q 2021). Revenue: US$1.28m (down 2.4% from 3Q 2021). Net loss: US$14.9m (loss widened 100% from 3Q 2021). Revenue is forecast to grow 118% p.a. on average during the next 2 years, compared to a 62% growth forecast for the Biotechs industry in Norway. Board Change • Nov 16
No independent directors There are 5 new directors who have joined the board in the last 3 years. Of these new board members, none were independent directors. The company's board is composed of: No independent directors. 8 non-independent directors. Deputy Board Member Jan Greve was the last director to join the board, commencing their role in 2022. The following issues are considered to be risks according to the Simply Wall St Risk Model: Lack of independent directors. Lack of board continuity. 