Slide 1: VB10.16 Outline of further clinical development in HPV16-positive malignancies
VB10.16 Outline of further clinical development in HPV16-positive malignancies December 20, 2022
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 MICHAEL ENGSIG AGNETE FREDRIKSEN KLAUS EDVARDSEN Chief Executive Chief Business Officer & Chief Development Officer Officer Co-founder Wide-ranging experience More than 20 years Extensive experience from from leading early-stage experience with APC- leading
Slide 4: VB10.16 Clinical Summary VB C-02
VB10.16 Clinical Summary VB C-02
Slide 5: VB C-02: VB10.16 + Atezolizumab in advanced Cervical Cancer – Study on track
VB C-02: VB10.16 + Atezolizumab (Tecentriq®) in advanced Cervical Cancer – Study on track A Multi-Centre, Single Arm, Open-label Phase 2a Trial of the Combination of VB10.16 and atezolizumab in Patients with Advanced or Recurrent, Non-resectable HPV16 Positive Cervical Cancer (NCT04405349) Objecti
Slide 6: 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 7: Link between vaccine-induced immune responses and clinical efficacy in advanced cervical cancer
Link between vaccine-induced immune responses and clinical efficacy in advanced cervical cancer VB10.16: HPV16 vaccine (VB C-02) DEEP CLINICAL RESPONSES LONG-LASTING CLINICAL RESPONSES T CELL VS BEST OVERALL RESPONSE Best Overall Response 100 1000 % change lesion size 50 SFU/106 PBMC 100 20 0 10 -30
Slide 8: VB10.16 - Safety summary
VB10.16 - Safety summary VB10.16 is generally well tolerated and safe – both as monotherapy and in combination with a PD-L1 inhibitor VB-C-01 trial • No SAEs occurred in 34 female subjects with HPV16+ CIN 2/3 receiving 3 or 4 vaccinations of 3 mg dose. • 2 subjects experienced grade 3 events within
Slide 9: VB10.16 Clinical development
VB10.16 Clinical development 9
Slide 10: Incidence of various HPV16+ cancers
Incidence of various HPV16+ cancers Prophylactic HPV vaccination program coverages suggest a continued unmet need The addressable market for VB10.16 represents a significant opportunity with additional market expansion potential from the unmet need represented by the PD-L1 negative patient populatio
Slide 11: VB10.16 – Planned clinical development in HPV16-positive related cancer types
VB10.16 – Planned clinical development in HPV16-positive related cancer types Improving patient outcomes in various HPV16-positive related cancer types with high unmet needs by combining VB10.16 with a PD-(L)1 inhibitor Cervical cancer • Study VB10.16 in combination with PD-(L)1 inhibitor in recurre
Slide 12: VB-C-03 trial in advanced HPV16-positive Head and Neck cancer with pembrolizumab
VB-C-03 trial in advanced HPV16-positive Head and Neck cancer in combination with pembrolizumab Single arm phase Ib/IIa dose escalation trial in patients with first line recurrent or metastatic squamous cell head and neck cancer (HNSCC) Key eligibility criteria Dosing schedule VB10.16 HPV16+,
Slide 13: VB-C-04 trial with potential registrational intent in advanced HPV16-positive cervical cancer
VB-C-04 trial with potential registrational intent in advanced HPV16-positive cervical cancer Single arm phase II trial in patients refractory to chemotherapy + pembrolizumab +/- bevacizumab Key eligibility criteria Combination treatment until progression or HPV16+, recurrent or metastatic cer
Slide 14: Basket trial in other HPV16-positive cancer types
Basket trial in other HPV16-positive cancer types Potential investigator initiated basket trial with option for expansion Key eligibility criteria Dosing schedule VB10.16 HPV16+ anal, penile, vaginal and/or vulvar Combination treatment administered for up to 1 year cancer Dosing schedule C
Slide 15: Current treatment landscape for PD-L1 negative patient population
Current treatment landscape for PD-L1 negative patient population • Chemotherapy-based regimens are current standard of care in US and EU for PD-L1 negative patients with recurrent or metastatic HPV16+ cancer • Around 15-20% of patients with recurrent or metastatic HPV16+ cancers are PD-L1 negative
Slide 16: VB10.16 - Clinical Development Overview of completed, ongoing and planned clinical trials
VB10.16 - Clinical Development Overview of completed, ongoing and planned clinical trials Phase 1 Phase 2 VB-C-02 Phase 2a VB10.16 + atezolizumab VB-C-01 Phase 1 >1L R/M disease HPV16+ VB10.16 monotherapy Cervical Cancer High Grade Cervical Intraepithelial Neoplasia (HSIL; CIN 2/3) VB-C-04 Phase 2
Slide 17: Financial overview
Financial overview Nykode Therapeutics | VB10.16 development plan | Non -confidential 17
Slide 18: Strong financial foundation for achieving our vision
Strong financial foundation for achieving our vision Financially well positioned to grow and execute the Company’s strategy over the next years Strong financial position Strong balance sheet with cash position of $212 mill at September 30, 2022 Successful listing on main list of Oslo Stock Exc
Slide 19: Recent Achievements and Upcoming Catalysts
Recent Achievements and Upcoming Catalysts Key Priorities Program Indication Partnerships Milestones 1 ✓ Provided additional interim data ✓ Provide updated development strategy • Advance internal oncology VB10.16 HPV16+ cervical cancer programs including cervical (off-the-shelf) • Present updated Ph
Slide 20: Unlocking the future of medicine
UNLOCKING THE FUTURE OF MEDICINE Contact: Agnete Fredriksen CBO IR@nykode.com Nykode Therapeutics | VB10.16 development plan | Non -confidential