Nykode Therapeutics Asa · OSL:NYKD
Nykode Therapeutics Asa — Q1 2024 Earnings Presentation
28 slides from Nykode Therapeutics Asa's earnings presentation, May 14, 2024
Slide 1: Q1 2024 Results Presentation
Q1 2024 Results Presentation May 14, 2024
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 KLAUS EDVARDSEN Chief Executive Officer Chief Scientific Officer & Chief Financial Officer Chief Research & Business Development Development O
Slide 4: Q1 2024 Highlights
Q1 2024 Highlights • Presented top line conclusions from the updated analysis from the Phase 2 VB-C-02 trial in advanced cervical cancer, affirming prolonged benefits and indicating a synergistic treatment effect of VB10.16 and atezolizumab (Tecentriq®). • Announced advances in the inverse vaccine p
Slide 5: Post-period end Highlights
Post-period end Highlights • Initiated Phase 2 VB-C-04 trial in second line HPV16-positive cervical cancer in patients with HPV16-positive, PD-L1-positive, recurrent, or metastatic cervical cancer. • Concluded enrollment of the 6 mg cohort in the VB-C-03 (VB10.16) trial in first-line head and neck c
Slide 6: Broad pipeline targeting early to late-stage cancer treatment
Broad pipeline targeting early to late-stage cancer treatment Upcoming Asset Indication Rights Preclinical Phase 1 Phase 2 Phase 3 Catalyst Oncology 1 Finalize enrolment Pt 1 HPV16+ cervical cancer C-02, C-04 (Q4 2024) 2 Dose level VB10.16 HPV16+ head and neck cancer C-03 recommendation (H2 2024) 2
Slide 7: R&D update
R&D update Nykode Therapeutics | Q1 '24 webcast | Non-confidential 7
Slide 8: VB10.16 C-02 data compare strongly to CPI monotherapy as well as expected SoC
VB10.16 C-02 data compare strongly to CPI monotherapy as well as expected SoC in ≥2L r/m cervical cancer CPI Monotherapy in r/m CC VB10.16 plus atezolizumab Atezolizumab in Pembrolizumab Cemiplimab in Tisotumab vedotin in PD-L1+ PD-L1+††† in PD-L1+** PD-L1+ †† (PD-L1 agnostic) ‡ ‡ (analysis from Apr
Slide 9: Maximizing addressable patient populations by diversifying offerings and broadening therapeutic scope
Maximizing addressable patient populations by diversifying offerings and broadening therapeutic scope Building a cancer vaccine franchise following strong clinical validation Validation Today Future Opportunities C-05 Adjuvant Settings Move earlier to expand patient population and Indication Expansi
Slide 10: VB10.NEO Individualized cancer immunotherapy
VB10.NEO Individualized cancer immunotherapy Nykode Therapeutics | Q1 '24 webcast | Non-confidential 10
Slide 11: VB10.NEO key differentiators
Solid manufacturing chain Safety Safety profile similar to 100% successful checkpoint inhibitor monotherapy vaccine production No increase in immune-related Robust supply chain adverse events NeoSELECT Immune response High fraction of VB10.NEO Induces broad and strong immunogenic neoanti
Slide 12: APC-targeted DNA vaccine induces a broader and stronger T cell response than peptide vaccines
APC-targeted DNA vaccine induces a broader and stronger T cell response than peptide vaccines VB10.NEO VB10.NEO The magnitude of the T cell responses are optimal with triweekly vaccination interval Nykode Therapeutics | Q1 '24 webcast | Non-confidential 12
Slide 13: APC targeted vaccine induce potentiated CD8 T cell phenotypes
APC targeted vaccine induce potentiated CD8 T cell phenotypes cell cycle • Prominent increased expression of cell cycle, checkpoint and effector genes with VB10.NEO compared to peptide + adjuvant checkpoint vaccines • CD8 T cell transcription factor profile consistent with higher chemokine receptors
Slide 14: Nykode's platform potential further supported by recent experience with VB10.NEO
Nykode's platform potential further supported by recent experience with VB10.NEO • VB10.NEO is able to induce a broad and CD8 dominating T cell response both as pDNA and mRNA vaccines • VB10.NEO induces a T cell profile consistent with higher differentiation towards effector/effector memory phenotyp
Slide 15: Autoimmunity platform update
Autoimmunity platform update Nykode Therapeutics | Q1 '24 webcast | Non-confidential 15
Slide 16: Why Tolerance
Why Tolerance Nykode Therapeutics | Q1 '24 webcast | Non-confidential 16
Slide 17: Induction of antigen specific tolerance can be achieved by targeting disease causing epitopes to tolerogenic APCs
Induction of antigen specific tolerance can be achieved by targeting disease causing epitopes to tolerogenic APCs MECHANISM OF ACTION – TOLERANCE INDUCTION (INVERSE VACCINATION) Cells transfected with Effector DNA plasmid B cell vaccine Tol CD4+ Treg APC CD4+ Treg Tol APC Effector Effector T cell T
Slide 18: APC targeting is required for effective disease protection
APC targeting is required for effective disease protection EAE MODEL 30 µg 3 µg 0.3 µg Tol. TV004 TV042 5 5 APC 5 PBS 4 4 4 EAE score EAE score EAE score 3 3 3 2 2 2 1 1 1 0 0 0 6 8 10 12 14 16 18 20 22 24 26 28 6 8 10 12 14 16 18 20 22 24 26 28 6 8 10 12 14 16 18 20 22 24 26 28 MOG MOG Days post EA
Slide 19: Vaccibody delivers Ag-specific suppression of EAE
Vaccibody delivers Ag-specific suppression of EAE EAE MODEL – OVA CONTROL TV004 TV043 OVA control 5 4 MOG OVA EAE score (27-63) (323-339) 3 TV004 2 TV043 Daily clinical scores PBS day -3 day 0 day 28 1 day -7 EAE Termination 0 induction i.v. 6 8 10 12 14 16 18 20 22 24 26 28 Pertussis toxin Days pos
Slide 20: Vaccibody vaccine prevents EAE disease in an early therapeutic setting
Vaccibody vaccine prevents EAE disease in an early therapeutic setting EAE MODEL – EARLY THERAPEUTIC DELIVERY TV004 5 ✱✱✱ TV004 100 4 PBS 80 EAE score AUC (5-28) MOG (27-63) 3 60 2 40 Daily clinical scores (5-28) 1 20 day 28 0 0 Termination EAE 0 2 4 6 8 10 12 14 16 18 20 22 24 26 28 PBS TV004 induc
Slide 21: DNA vaccination with Vaccibody induces long-lasting efficacy post treatment in a diabetes model
DNA vaccination with Vaccibody induces long-lasting efficacy post treatment in a diabetes model Dosing once weekly until week 16 Week 16 of treatment Wk 0 Wk 1 Wk2 Wk 3 Wk 4 Wk 5……… Weekly monitoring Remove treatment Still ongoing 9 wk old mice NOD DIABETES MODEL (ONGOING STUDY) VB vaccine Incidence
Slide 22: Recent Autoimmunity Results Supports the Potency in Nykode's APC-targeted platform
Recent Autoimmunity Results Supports the Potency in Nykode’s APC-targeted platform DIABETES MODEL: DNA vaccination with Vaccibody targeting tolerizing APCs show potent prevention of diabetes in NOD mice Co-expression of selected immune-modulatory cytokines protects all mice from diabetes with du
Slide 23: Q1 2024 Financial Results
Q1 2024 Financial Results
Slide 24: Income Statement
Income Statement Revenue from contracts with customers Amounts in USD ‘000 Q1 2024 Q1 2023 FY 2023 • R&D activities under Genentech and Regeneron Revenue from contracts with customers 827 3,126 12,902 agreements Other income 189 181 421 • $0.7m (Q1 2024) and $2.5m (Q1 2023) under Total revenue and o
Slide 25: Balance Sheet
Balance Sheet Cash and cash equivalents Amounts in USD ‘000 31/03/2024 31/12/2023 • Strong cash position of $147.3m at March 31, 2024 ASSETS Non-current assets Other non-current receivables Property, plant and equipment 4,242 4,413 • Mainly reflects the NOK 325 million payment to the Right-of-use as
Slide 26: Balance Sheet - contd.
Balance Sheet - contd. Amounts in USD ’000 31/03/2024 31/12/2023 Equity EQUITY AND LIABILITIES • Total equity of $158.7m as per March 31, 2024 Equity Share capital 367 367 • Equity ratio of 83% Share premium 128,986 128,986 Other capital reserves 17,298 15,395 Other components of equity (3,046) (3,0
Slide 27: Upcoming milestones
Upcoming milestones Q1 ‘24 VB10.16 Cervical Cancer Updated survival data from VB-C-02 Phase 2 trial Q2 ‘24 VB10.16 Cervical Cancer Initiate potentially registrational VB-C-04 trial in the U.S. in patients with recurrent/metastatic disease and PD-L1 positive tumors Oncology H2 ‘24 VB10.16 Recomme
Slide 28: Unlocking the future of medicine
UNLOCKING THE FUTURE OF MEDICINE Contact: Alexandra Deschner Head of Investor Relations IR@nykode.com Nykode Therapeutics | Q1 '24 webcast | Non-confidential