Slide 1: Q4 Presentation
Q4 Presentation February 28, 2023
Slide 2: Forward-looking statement
Forward-looking statement This announcement and any materials distributed in connection with this presentation may contain certain forward- looking statements. By their nature, forward-looking statements involve risk and uncertainty because they reflect the company’s current expectations and assumpt
Slide 3: Today's presenters from Nykode management
Today’s presenters from Nykode management International management team with solid drug development experience MICHAEL ENGSIG AGNETE FREDRIKSEN HARALD GURVIN Chief Executive Chief Business Officer & Chief Financial Officer Co-founder Officer Nykode Therapeutics | Q4 webcast | Non-confidential
Slide 4: Global leader in APC-targeted immunotherapy technology
Global leader in APC-targeted immunotherapy technology NYKODE THERAPEUTICS (NYKD-OL, MKT CAP ~$800M) Proprietary immunotherapies targeting antigens to Antigen-Presenting Cell (APC) and generating strong CD8 killer T cell responses correlated with clinical responses in solid tumors Modular, versatile
Slide 5: 4Q highlights
4Q highlights Clinical programs • Announced positive immunogenicity results from a Phase 1/2a trial of VB10.NEO in multiple indications • Presented additional efficacy analysis from a Phase 2 trial of VB10.16 in advanced cervical cancer • Announced clinical collaboration and drug supply of KEYTRUDA®
Slide 6: VB10.NEO positive immunogenicity results N-01
VB10.NEO positive immunogenicity results N-01 Nykode’s individualized cancer vaccine Nykode Therapeutics | Q4 webcast | Non-confidential
Slide 7: Nykode is a key player in the field of individualized cancer vaccines
Nykode is a key player in the field of individualized cancer vaccines Individualized neoantigen-specific vaccines custom-design and manufacture one vaccine per patient based on each patient’s cancer- specific mutations • Recent positive data announced by Moderna and Merck for their individualized ne
Slide 8: VB10.NEO: Individualized neoantigen immunotherapy for the treatment of broad range of solid tumor indications
VB10.NEO: Individualized neoantigen immunotherapy for the treatment of broad range of solid tumor indications ONGOING. REPORTED POSITIVE INTERIM DATA. ONGOING IN >10 INDICATIONS, COLLABORATION WITH GENENTECH N-01 N-02 ◆VB10.NEO in combination with CPI ◆Dose escalation 3-9 mg VB10.NEO in ◆Melanoma, l
Slide 9: VB10.NEO: leading technology applicable for individualized cancer neoantigen immunotherapy
VB10.NEO: leading technology applicable for individualized cancer neoantigen immunotherapy Strong in-house bioinformatic competences and proprietary neoantigen selection method Trained on Nykode’s data and unique broad CD8 dominated immune response Focus on clonal and clinically relevant epitope
Slide 10: T-cell responses to the majority of selected neoepitopes
T-cell responses to the majority of selected neoepitopes % immunogenic Neoepitopes per patient 100% of patients across five indications showed a response to at least three Indication neoepitopes (at least one time point) UC 60 51% % of neoepitopes SCCHN 35% On average, 53% of selected 40 24% neoepit
Slide 11: VB10.NEO amplifies pre-existing T-cell responses and induces multiple novel T-cell specificities
VB10.NEO amplifies pre-existing T-cell responses and induces multiple novel T-cell specificities Expansion of pre-existing and induction of novel T cells De novo response Expansion of both pre-existing and novel Amplified response T-cell responses in most patients (at least Indication Stable respons
Slide 12: Preliminary immune phenotyping shows that the majority of neoepitopes activate CD8 T cells
Preliminary immune phenotyping shows that the majority of neoepitopes activate CD8 T cells CD8 T cells response detected No CD8 T cells response detected T cell responses are characterized by both CD8 and CD4 T cells 53% 100% 75% 100% 100% 80% (at week 22) 01-001 01-005 01-002 01-004 01-006 02-003 C
Slide 13: VB10.16 rapidly advancing wholly owned asset
VB10.16 rapidly advancing wholly owned asset Nykode’s off the shelf vaccine targeting HPV16+ cancers Nykode Therapeutics | Q4 webcast | Non-confidential
Slide 14: HPV16+ cancers represent significant unmet need
HPV16+ cancers represent significant unmet need Prophylactic HPV vaccination program coverages suggest a continued need Approximately 58,500 new HPV16+ cancer cases per HPV vaccination program is not expected to impact year in the U.S. and EU51 the rate of HPV related cancer incidence for the next d
Slide 15: VB10.16: HPV16-targeted immunotherapy with broad potential across HPV-driven cancers
VB10.16: HPV16-targeted immunotherapy with broad potential across HPV-driven cancers FINALIZED. REPORTED ONGOING. REPORTED EXPANSION PLANNED FOR 2023 FURTHER POTENTIAL POSITIVE DATA POSITIVE INTERIM DATA C-01 Pre- C-02 C-03 C-04 Other HPV+ cancerous Cervical Head and Cervical driven cancers Cervical
Slide 16: C-02 included a heavily pre-treated population with advanced cervical cancer
C-02 included a heavily pre-treated population with advanced cervical cancer Study design Characteristic N (%) Age (mean) 48.9 yrs Age (median) 47.0 yrs Fully enrolled with 52 patients Prior systemic treatment lines 1 12 (31%) Conducted in Europe in 6 countries 2 15 (39%) Enrolled patients rec
Slide 17: Positive interim results from Phase 2 study of VB10.16 with TECENTRIQ in advanced cervical cancer
Positive interim results from Phase 2 study of VB10.16 in combination with TECENTRIQ® in advanced cervical cancer ► Heavily pre-treated (1-5 lines of prior systemic therapy) recurrent/metastatic cervical cancer patient population Anti-tumor activity observed in majority of patients including 2 CRs a
Slide 18: Anti-tumor activity observed in patients with positive and negative baseline PD-L1 status
Anti-tumor activity was observed both in patients with positive and negative baseline PD-L1 status Tumor regression in PD-L1 +/- 1 0 0 PD-L1 pos PD-L1 ORR (n/N) DCR (n/N) PD-L1 neg status 5 0 % change lesion size 20 Positive 27% (6/22) 77% (17/22) 0 (TIC 1-2) -30 -5 0 Negative N=33 17% (2/12) 58% (7
Slide 19: Near term key inflection points in 1H 2023
Near term key inflection points in 1H 2023 Long-term follow up including durability and survival readouts C-02, start of C-03 C-02 C-03 Cervical Head and Cancer Neck Cancer Updated durability results from Phase 2 study FPFD in dose escalation (3-9 mg VB10.16) • minimum 12 month follow-up • PD-L1+ pa
Slide 20: Preparing for FPFD in a potential registrational trial in cervical cancer in collaboration with GOG
Preparing for FPFD in a potential registrational trial in cervical cancer in collaboration with GOG C-04 Cervical Cancer To be initiated in Q4 HPV16+, recurrent or metastatic cervical cancer Refractory to first line treatment with CPI High unmet medical need Potential for fast to market VB
Slide 21: Strategic partnership with Richter Helm to secure and optimize manufacturing
Strategic partnership with Richter Helm to secure and optimize manufacturing Manufacturing capacity (1000L Bovenau, 200L Hannover) • Highly reputable plasmid DNA manufacturer with a proven track record • Highly comparable COG’s • Flexible forecasting model to secure capacity for entire portfolio Pro
Slide 22: Organization
Organization
Slide 23: Continued strong growth across the organization (Current Employees)
Continued strong growth across the organization (Current Employees) Distribution 28.02.2023 Employees 2020 to 2023 175 157 150 Staff / Other 13 % 125 102 Development 38 % 100 75 51 50 25 Research 50 % 0 2020 2021 2022 28.02.2023 Nykode Therapeutics | Q4 webcast | Non-confidential
Slide 24: Financials
Financials
Slide 25: Strong financial foundation for achieving our vision
Strong financial foundation for achieving our vision Cash position of $206m year-end 2022 Financially well positioned to grow and Successful listing on main list of execute the Company’s strategy over Oslo Stock Exchange in June 2022 the next years Included in Oslo Børs Benchmark Index (OSEBX)
Slide 26: Income Statement
Income Statement Revenue from contracts with customers Amounts in USD ‘000 Q4 2022 Q4 2021 FY 2022 FY 2021 • R&D activities under Genentech and Regeneron Revenue from contracts with customers 2,690 30,908 7,168 33,963 agreements Other income 610 865 1,861 1,803 • $2.5m (Q4 2022) and $6.3m (FY 2022)
Slide 27: Balance Sheet
Balance Sheet Cash and cash equivalents Amounts in USD ‘000 31/12/2022 31/12/2021 • Strong cash position of $206m at December 31, ASSETS 2022 Non-current assets Other current financial assets Property, plant and equipment 3,518 1,884 Right-of-use assets 6,009 7,281 • Sale of money market funds in 20
Slide 28: Balance Sheet - contd.
Balance Sheet - contd. Amounts in USD ’000 31/12/2022 31/12/2021 Equity EQUITY AND LIABILITIES • Total equity of $157m as per December 31, 2022 Equity Share capital 338 333 • Equity ratio of 71% Share premium 83,318 81,526 Other capital reserves 11,695 7,863 Other components of equity (3,044) (3,122
Slide 29: 2022 Achievements
2022 Achievements VB10.16 VB10.2210 VB10.NEO All Cervical Head and COVID Individualized Manufacturing Cancer Neck Cancer Cancer Vaccine Reported positive Entered into an Reported positive Reported positive Entered into interim results from agreement with results from Ph 1/2 immunogenicity results st
Slide 30: Upcoming milestones for Nykode's wholly owned programs
Upcoming milestones for Nykode’s wholly owned programs 1H VB10.16 Updated durability results from Phase 2 study; minimum 2023 Cervical Cancer 12 month follow-up 1H VB10.16 First patient dosed in C-03 trial with KEYTRUDA® in 2023 Head and Neck Cancer patients with unresectable recurrent or metastatic
Slide 31: Unlocking the future of medicine
UNLOCKING THE FUTURE OF MEDICINE Contact: Agnete Fredriksen CBO IR@vaccibody.com Nykode Therapeutics | Q4 webcast | Non-confidential