Nykode Therapeutics Asa · OSL:NYKD
Nykode Therapeutics Asa — H1 2022 Earnings Presentation
31 slides from Nykode Therapeutics Asa's earnings presentation, Aug 24, 2022
Slide 1: 1H 2022 Financial Results Presentation
1H 2022 Financial Results Presentation August 24, 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 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 Wide-ranging experience from More than 20 years experience
Slide 4: Overview
Overview VISION STRONG VALIDATING PARTNERSHIPS To build the leading immunotherapy company Potentially > $1.64B in payments + additional developing game changing medicine across an royalties from top-tier partners Regeneron, expanding range of therapeutic areas Genentech and Adaptive UNIQUE THERA
Slide 5: 1H 2022 highlights
1H 2022 highlights Technology and clinical programs • Nykode Therapeutics announced positive interim results from its Phase II trial with VB10.16 in combination with atezolizumab in heavily pre-treated patients with advanced cervical cancer • Enhanced ORR and DCR with long-lasting response • Efficac
Slide 6: 1H 2022 highlights
1H 2022 highlights Finance • Nykode converted to public limited liability company and uplisted to the main list of the Oslo Stock Exchange Organization • Elaine Sullivan and Anne Whitaker elected to join the Board of Directors at the Company’s AGM on May 12, 2022 • Nykode appointed Klaus Edvardsen a
Slide 7: VB10.16 interim data C-02
VB10.16 interim data C-02 Nykode’s off the shelf vaccine targeting HPV16+ cancers Nykode Therapeutics | Webcast | Non-confidential 7
Slide 8: VB C-02: VB10.16 in combination with atezolizumab in advanced cervical cancer
VB C-02: VB10.16 in combination with atezolizumab in advanced cervical cancer 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) Objectives: safety/
Slide 9: Baseline characteristics of EAS population
Baseline characteristics of EAS population C-02 included a heavily pre-treated population with advanced cervical cancer Characteristic N (%) Characteristic N (%) Age (mean) 48.9 yrs ECOG Age (median) 47.0 yrs 0 22 (56%) Ethnicity (White) 39 (100%) 1 17 (44%) Prior systemic treatment lines PD-L1 stat
Slide 10: VB10.16 with atezolizumab showed promising efficacy with durable responses
VB10.16 in combination with atezolizumab showed promising efficacy with durable responses 100 Complete/Partial Response Stable Disease Progressive Disease % change lesion size 50 20 0 • Durable responses in the DCR population 30 • 6 out of 8 ORR patients -50 have an ongoing response -100 0 3 6 9 12
Slide 11: Anti-tumor activity 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 12: Disease control achieved in patients with non-inflamed tumors at baseline
Disease control achieved in patients with non-inflamed tumors at baseline T cell excluded tumor 10 of 14 patients with non-inflamed tumor immune CD3 CD8 Ck status at baseline achieved disease control on combination treatment DCR Immune Desert Non-inflamed tumors 10 of 14 (71%) CD3 CD8 Ck T cell excl
Slide 13: VB C-02: Positive interim results from VB C-02 May 2022
VB C-02: Positive interim results from VB C-02 May 2022 Conclusions • VB10.16 in combination with atezolizumab showed durable responses with a very high disease control rate (DCR) of 64% in heavily pre-treated advanced cervical cancer patients • Anti-tumor efficacy was observed in both PD-L1 positiv
Slide 14: Further platform potential
Further platform potential Nykode Therapeutics | Webcast | Non-confidential 14
Slide 15: Nykode’s modular platform enables generation of multiple specific and innovative products
Nykode’s modular platform enables generation of multiple specific and innovative products APC-specific Ag delivery and Expanded use of modularity stimulation Building additional Novel Infectious disease Cancer vaccines combinations and vaccines modules structures Vaccines against Novel therapeutics
Slide 16: Further platform improvement by adding a 4th module
Further platform improvement by adding a 4th module Adding gas pedal, brake and/or steering wheel CT26 tumor model 10 µg dose GM: GM-CSF FL: FLT3L Nykode Therapeutics | Webcast | Non-confidential Poster presentation at 2022 AACR Annual meeting 16
Slide 17: 4th module also applicable for infectious diseases
4th module also applicable for infectious diseases Different 4th modules boost both antibody and T cell responses VB-COV2 Antibody VACCINE INDUCED responses ANTIBODY RESPONSES T cell VACCINE INDUCED IFNresponses g T CELL RESPONSES RBD RBD RBD RBD + VB-COV2+GM VB-COV2+GM VB-COV2 VB-COV2 VB-core VB-CO
Slide 18: Targeting unit offers unique ability to explore Ag-specific immune tolerance
Targeting unit offers unique ability to explore Ag-specific immune tolerance CANCER AND INFECTIOUS DISEASE AUTOIMMUNITY, ALLERGY ETC Stimulatory Tolerogenic DC DC Natural ligands or scFv binding diverse set of surface receptors IL-12, IFNγ, TNFα, IFNα, IL-6 IL-10, TGFβ, IDO, PD-1, ARG TH 1, TH, 17,
Slide 19: APC-targeted technology and 4th module offers unique ability to induce immune tolerance
APC-targeted technology and 4th module offers unique ability to induce Ag-specific immune tolerance Tolerizing Tolerizing vaccine design Nykode vaccine Targeting specific receptor on tolerizing antigen presenting cells 4th module immune inhibitory cytokine T-reg cells Proliferating T-reg cells 4
Slide 20: Nykode is focusing on three strategic priorities
Nykode is focusing on three strategic priorities •Clinical pipeline in multiple disease areas incl products with broad potential Rapidly advance existing assets through •Promising clinical data from VB C-01, VB C-02 and VB N-01 the clinic •Favorable safety profile, correlation of immune responses an
Slide 21: Organization
Organization 21
Slide 22: Continued strong growth across the organization (current employees)
Continued strong growth across the organization (current employees) Distribution on Number of employees August 15, 2022 from 2020 to 2022 Staff / Other; 13% 142 125 102 100 Development ; 75 51 35% 50 Research; 53% 25 0 2020 2021 2022 August 15 CE Nykode Therapeutics | Webcast | Non-confidential 22
Slide 23: Strengthening the Nykode leadership team
Strengthening the Nykode leadership team KLAUS EDVARDSEN LOUISE STUBBE • International experience from biotech and Big Pharma with CHIEF DEVELOPMENT OFFICER CHIEF LEGAL OFFICER extensive early and Extensive experience from leading drug More than a decade of life sciences industry late stage drug dev
Slide 24: Continuing the internationalization with two new industry experienced members
Continuing the internationalization with two new industry experienced members Elaine Sullivan Anne Whitaker • International executive level Currently, serves as: Currently serves as: • Drug development • CEO of Keltic Pharma Therapeutics Ltd • Chairman of Aerami Therapeutics, Inc. and • Various Non-
Slide 25: Financials
Financials 25
Slide 26: Highlights
Highlights Financially well positioned to grow Successful listing on the main list and execute the Company’s of Oslo Stock Exchange strategy over the next years First day of trading June 16, Strong balance sheet with total 2022 liquidity1 of $223 mill at June 30, To facilitate greater liqu
Slide 27: Income Statement
Income Statement Revenue from contracts with customers Amounts in USD ‘000 Q2 2022 Q2 2021 YTD 2022 YTD 2021 • R&D activities under Genentech and Regeneron Revenue from contracts with customers 3,114 1,607 3,830 2,054 agreements Other income 309 291 617 625 • $2.9m (2Q 2022) and $3.4m (1H 2022) unde
Slide 28: Balance Sheet
Balance Sheet Cash and cash equivalents Amounts in USD ‘000 30/06/2022 31/12/2021 • Strong cash position of $213.3m as per June 30, ASSETS 2022 Non-current assets Property, plant and equipment 2,771 1,884 Other current financial assets Right-of-use assets 6,698 7,281 • Liquid money market funds of $
Slide 29: Balance Sheet - contd.
Balance Sheet - contd. Amounts in USD ’000 30/06/2022 31/12/2021 Equity EQUITY AND LIABILITIES • Total equity of $181.1m as per June 30, 2022 Equity Share capital 334 333 • Equity ratio of 76% Share premium 82,314 81,526 Other capital reserves 9,682 7,863 Other components of equity (3,056) (3,122) R
Slide 30: Upcoming Catalysts
Upcoming Catalysts 2022 Key Priorities Program Indication Partnerships Milestones Wholly-Owned Candidates • Present updated Phase 2 data (1H • Advance internal oncology 2023) programs including cervical VB10.16 HPV16+ cervical cancer (off-the-shelf) cancer program • Provide updated development strat
Slide 31: Unlocking the future of medicine
UNLOCKING THE FUTURE OF MEDICINE Contact: Agnete Fredriksen Chief Business Officer IR@vaccibody.com Nykode Therapeutics | Webcast | Non-confidential