Nykode Therapeutics Asa · OSL:NYKD
Nykode Therapeutics Asa — Q3 2022 Earnings Presentation
37 slides from Nykode Therapeutics Asa's earnings presentation, Nov 23, 2022
Slide 1: Q3 Presentation
Q3 Presentation November 23, 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: On our way to build the leading immunotherapy company
On our way to build the leading immunotherapy company CLINICALLY VALIDATED PLATFORM TOP TIER COLLABORATORS BROAD FUTURE POTENTIAL • Pipeline with clinical products • Broad clinical experience applicable for multiple indications • 4 clinical products • 5 clinical trials in 8 countries • Platform appl
Slide 5: 3Q highlights
3Q highlights Clinical programs •Nykode announced positive results from its Phase 1/2 trial with the T-cell focused SARS-CoV-2 vaccine •Nykode Therapeutics announced positive immunogenicity results from its Phase 1/2a trial with VB10.NEO, an individualized therapeutic cancer vaccine •Nykode presente
Slide 6: 3Q highlights
3Q highlights Finance •Nykode included in the Oslo Børs Index (OSEBX) and the Oslo Børs Mutual Fund Index (OSEFX) • Strong cash position of USD 212 million Organization • Company continued onboarding of new talent reaching 153 employees by November 15, 2022 Nykode Therapeutics | Q3 webcast | Non-con
Slide 7: VB10.COV2 positive results D-01
VB10.COV2 positive results D-01 Nykode’s Covid-19 vaccine Nykode Therapeutics | Q3 webcast | Non-confidential
Slide 8: VB10.2210 includes a large set of validated and conserved viral T cell epitopes
VB10.2210 includes a large set of 96 validated and conserved viral T cell epitopes • High mutational drift in Spike are likely to affect both Spike-specific antibody and T cell Targeting unit: responses CCL3L1 • VB10.2210 is designed to induce T cell responses against Spike and seven additional anti
Slide 9: First-in-human trial investigating VB10.2210 as booster in previously vaccinated subjects
First-in-human trial investigating VB10.2210 as booster in previously vaccinated subjects A Phase 1/2, open label, dose escalation trial to determine safety and of the T-cell candidate (VB10.2210) (NCT05069623) Booster in Covid-19 naïve healthy adults (18-60y) Vaccinated with at least 2 doses mR
Slide 10: VB10.2210 induced de novo T cell responses to all four non-Spike antigens
VB10.2210 induced de novo T cell responses to all four non-Spike antigens conserved across SARS-CoV-2 variants SPIKE EPITOPES M EPITOPES N epitopes ORF 1ab, 3, 10 epitopes ORF 7 EPITOPES PP2 400 200 1000 200 2000 150 1500 100 500 1000 IFNγ (SFU/106 cells) IFNγ (SFU/106 cells) IFNγ (SFU/106 cells) IF
Slide 11: VB10.2210 induces response to all peptide pools from Spike and Non-spike
VB10.2210 induces response to all 5 peptide pools from Spike and Non-spike Response > 1 peptide pool 82% 82% Spike 16% Membrane 20% • 82 % (9/11) of the subjects vaccinated 18 % 18 % with VB10.2210 responded to at least 1 peptide pool 9% Nucleocapsid • All peptide pools in VB10.2210 vaccine ORF7 ind
Slide 12: T cell responses dominated by polyfunctional CD8+ T cells
Preliminary data indicates that the T cell responses are dominated by polyfunctional CD8+ T cells • CD4/CD8 distribution Negative control determined in 5 patients • A dominant CD8 response observed in all 5 patients Baseline Peak Non-Spike epitopes in N, M, ORFs Responses to VB10.2210 were dominated
Slide 13: Conclusions and next steps
Conclusions and next steps • Successful proof of concept for the combination of Nykode’s APC-targeted Vaccibody technology with T cell epitopes from SARS-CoV-2 selected by Adaptive Biotechnologies • Confirms the ability of Nykode’s platform to generate broad T cell responses dominated by CD8 T cells
Slide 14: VB10.NEO positive immunogenicity results N-01
VB10.NEO positive immunogenicity results N-01 Nykode’s individualized cancer vaccine Nykode Therapeutics | Q3 webcast | Non-confidential
Slide 15: VB10.NEO: Nykode's individualized cancer vaccine
VB10.NEO: Nykode’s individualized cancer vaccine Targeting antigen presenting cell Proprietary neoantigen selection method Majority of selected neoepitopes are immunogenic VB10.NEO Frequency of high-quality neoepitopes in vaccine and Fully individualized immune responses correlate with responses
Slide 16: VB N-01 – Population and baseline characteristics
VB N-01 – Population and baseline characteristics VB N-01 included a population with various pre-treated and advanced cancer types Population* N Characteristic N (%) Characteristic N (%) VB10.NEO dosed patients (safety 41 Mean Age (range) 62.6 yrs (33-81 ys) Prior systemic treatment lines population
Slide 17: T-cell responses to majority of selected neoepitopes
T-cell responses to majority of % immunogenicNeoepitopesper patient selected neoepitopes Indication UC 100% of patients across five indications SCCHN 60 51% % of neoepitopes showed a response to at least one neoepitope 35% 40 24% RCC On average, 53% of selected 20 15% 10% neoepitopes were immunogeni
Slide 18: VB10.NEO amplify pre-existing T-cell responses and induce novel T-cell specificities
VB10.NEO amplify pre-existing T-cell responses and induce novel T-cell specificities De novo response Amplified response Stable response Indication UC Expansion of both pre-existing and novel T-cell responses in most patients SCCHN • 20/21 (95%) de novo expanded • 14/21 amplification of pre-existing
Slide 19: Preliminary immune phenotyping shows majority of neoepitopes activates CD8 T cells
Preliminary immune phenotyping shows that the majority of neoepitopes activates 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 53 100 75 100 100 80 % % % % % % cells 01-001 01-005 01-002 01-004 01-006 02-003 CD8 CD4
Slide 20: Neoepitope-reactive CD8 and CD4 T cells are polyfunctional
Neoepitope-reactive CD8 and CD4 T cells are polyfunctional Polyfunctional CD8 and CD4 T cell responses RCC SCCHN Melanoma The majority of the CD4 CD8 CD4 CD8 CD4 CD8 neoepitopes induced a polyfunctional T cell response characterized by a Th1/Tc1 cytokine profile 0 1 -0 0 1 C D 4 01-001 CD8 01-002 CD
Slide 21: VB N-01: Summary
VB N-01: Summary • VB10.NEO was generally safe and well-tolerated in patients with solid tumors • A broad T cell response was observed in the majority of patients, inducing expansion of both novel and pre-existing T cells • Breadth and magnitude of immune response increased upon multiple vaccination
Slide 22: VB10.16 additional efficacy data C-02
VB10.16 01 additional efficacy data C-02 Nykode’s off the shelf vaccine targeting HPV16+ cancers Nykode Therapeutics | Q3 webcast | Non-confidential
Slide 23: 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 24: 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 25: Anti-tumor activity observed in majority of patients including 9 patients with SD+
Anti-tumor activity observed in majority of patients including 9 patients with SD+ 100 ORR = 21% Best Overall Response (8/39 patients) % change lesion size 50 20 DCR = 64% 0 (25/39 patients) -30 Median follow -50 up time (range) = 6 months (3-20 N=38 months) 1 NE; not evaluable -100 SD+ = SD with sh
Slide 26: Clinical response by prior systemic treatment line
Clinical response by prior systemic treatment line High disease control in patients with up to 2 prior lines T CELL RESPONSE IN PATIENTS WITH Number of prior systemic treatment lines ORR DCR DIFFERENT NUMBER OF PRIOR SYSTEMIC TREATMENTS 1 (n=12) 17% 75% 300 SFU/106 PBMC 2 (n=15) 40% 60% 200 3 (n=9)
Slide 27: Clinical response by number of extrapelvic metastases at baseline
Clinical response by number of extrapelvic metastases at baseline T CELL RESPONSE IN PATIENTS WITH DIFFERENT NUMBER OF EXTRA-PELVIC METASTASES 300 Number of extra-pelvic metastases ORR DCR SFU/106 PBMC 0 metastases (n=4) 25% 100% 200 1-5 metastases (n=22) 27% 73% >5 metastases (n=13) 8% 31% 100 0 0-
Slide 28: 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 29: Organization
Organization
Slide 30: Continued strong growth across the organization (Current Employees)
Continued strong growth across the organization (Current Employees) Employees 2020 to 2022 Distribution 15.11.2022 175 153 Staff / Other 150 16 % 125 Development 102 33 % 100 75 51 50 Research 25 52 % 0 2020 2021 2022 15.11 Nykode Therapeutics | Q3 webcast | Non-confidential
Slide 31: Financials
Financials
Slide 32: Highlights
Highlights Financially well positioned to grow Successful listing on main list of and execute the Company’s Oslo Stock Exchange in June 2022 strategy over the next years To facilitate greater liquidity in Strong balance sheet with cash the shares and attract new position of $212 mill at Sept
Slide 33: Income Statement
Income Statement Revenue from contracts with customers Amounts in USD ‘000 Q3 2022 Q3 2021 YTD 2022 YTD 2021 • R&D activities under Genentech and Regeneron Revenue from contracts with customers 648 1,001 4,478 3,055 agreements Other income 634 313 1,251 938 • $0.4m (Q3 2022) and $3.8m (YTD 2022) und
Slide 34: Balance Sheet
Balance Sheet Cash and cash equivalents Amounts in USD ‘000 30/09/2022 31/12/2021 • Strong cash position of $212m at September 30, ASSETS 2022 Non-current assets Other current financial assets Property, plant and equipment 2,873 1,884 Right-of-use assets 6,341 7,281 • Sale of money market funds in Q
Slide 35: Balance Sheet - contd.
Balance Sheet - contd. Amounts in USD ’000 30/09/2022 31/12/2021 Equity EQUITY AND LIABILITIES • Total equity of $167m as per September 30, 2022 Equity Share capital 334 333 • Equity ratio of 73% Share premium 82,314 81,526 Other capital reserves 10,620 7,863 Other components of equity (3,075) (3,12
Slide 36: Recent Achievements and Upcoming Catalysts
Recent Achievements and Upcoming Catalysts Key Priorities Program Indication Partnerships Milestones Wholly-Owned Candidates ✓ Provided additional data from interim analysis Ph2 • Present updated Phase 2 data (1H • Advance internal oncology VB10.16 HPV16+ cervical cancer 2023) programs including cer
Slide 37: Unlocking the future of medicine
UNLOCKING THE FUTURE OF MEDICINE Contact: Agnete Fredriksen CBO IR@vaccibody.com Nykode Therapeutics | Q3 webcast | Non-confidential