Nykode Therapeutics Asa · OSL:NYKD
Nykode Therapeutics Asa — Q1 2023 Earnings Presentation
37 slides from Nykode Therapeutics Asa's earnings presentation, May 2023
Slide 1: Q1 Presentation
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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 | Q1 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 ~$700M) 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: 1Q highlights
1Q highlights Clinical programs • Nykode announced collaboration with the gynecologic study group GOG Foundation to conduct the planned VB-C-04 trial in advanced cervical cancer. • Presented additional immunogenicity data from the Phase 1/2a clinical trial of VB10.NEO, Nykode’s individualized neoant
Slide 6: VB10.NEO positive immunogenicity results N-01
VB10.NEO positive immunogenicity results N-01 Nykode’s individualized cancer vaccine Nykode Therapeutics | Q1 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 by Moderna/Merck and BioNTech in early stage adjuvant sett
Slide 8: 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 9: VB10.NEO: Individualized neoantigen immunotherapy for 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 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: Multiple vaccinations boost the breadth and magnitude of immune responses
Multiple vaccinations boost the breadth and magnitude of immune responses VB10.NEO increased both the breadth and magnitude of neoantigen specific T cells T cell responses were assessed by IVS ELISpot towards individual neoantigens. For magntitude, stacked responses are shown. Median is indicated as
Slide 12: VB10.NEO induces T cell responses in hard-to-treat low-TMB patients
VB10.NEO induces T cell responses in hard-to-treat low-TMB patients Immune reactivity towards VB10.NEO Low TMB High TMB VB10.NEO demonstrate a high immune reactivity in a hard-to-treat population of low-TMB patients (<10 mut/Mb) • Indicating potential in broad range of cancer indications Nykode Ther
Slide 13: T cell clones were found in both tumor tissue and blood
T cell clones were found in both tumor tissue and blood Expansion of novel T cell clones in on-treatment tumor samples • T cell clones expanded in the tumor also found in blood • T cell clones found in the tumor expanded in blood • Indicates that vaccine-induced neoantigen-specific T cells in the pe
Slide 14: Preliminary immune phenotyping shows 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 53% 100% 75% 100% 100% 80% CD4 T cells • The majority of 01-001 01-005 01-002 01-004 01-006 0
Slide 15: VB N-01: Summary
VB N-01: Summary • VB10.NEO was generally safe and well-tolerated in patients with advanced cancer • The vaccine-induced T cell responses were broad and long-lasting • The majority of neoepitopes induced polyfunctional CD8 T cells • T cell responses were elicited in both TMB high and low patients su
Slide 16: 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 | Q1 webcast | Non-confidential
Slide 17: VB10.16: Therapeutic vaccine candidate for HPV16+ cancers
VB10.16: Therapeutic vaccine candidate for HPV16+ cancers Targeting unit Off-the-shelf therapeutic cancer DNA vaccine CCL3L1 against HPV16 induced malignancies HPV16 is the most prevalent oncogenic HPV strain VB10.16 Targeting the cancer-specific full-length HPV16 E7 and E6 Off-the-shelf vaccine
Slide 18: HPV16+ cancers are a significant unmet need
HPV16+ cancers are a significant unmet need Despite prophylactic HPV vaccination, HPV+ cancer incidence is expected to increase • 4th most common cancer in women worldwide HPV-related cancer incidence is expected to grow • 4th leading cause of cancer-related death HPV+ cervical cancer HPV+ HNSCC • P
Slide 19: Recent clinical progress has increased survival outcomes in advanced cervical cancer
Recent clinical progress has increased survival outcomes in advanced cervical cancer patients, but room for significant improvement remains Patients that have failed 1 or more line of systemic treatment have limited Progression Free Survival and Overall Survival with current approved treatments Sign
Slide 20: VB-C-02: VB10.16 plus atezolizumab in advanced cervical cancer
VB-C-02: VB10.16 plus atezolizumab (Tecentriq®) 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/to
Slide 21: VB10.16 evaluated in pretreated advanced cervical cancer patients
VB10.16 evaluated in pretreated advanced cervical cancer patients, with ~40% PD-L1 negative Baseline characteristics PATIENT CHARACTERISTICS1 SAF2 (n = 52) Median age, years (range) 47.5 (27-83) Histology Squamous cell carcinoma 81% (42/52) Adenocarcinoma 15% (8/52) Adenosquamous carcinoma 2%
Slide 22: Strong anti-tumor effect leading to prolonged overall survival
Strong anti-tumor effect leading to prolonged overall survival (compared to CPI alone)1 High mOS of >25 months (not reached) and mPFS 6.3 months in PD-L1+ patients Endpoint All patients (n = 472) PD-L1+ (n = 243) Value 95% CI Value 95% CI Strong and durable anti-tumor efficacy ORR 19% (9%-33%) 29%
Slide 23: VB10.16 coupled with CPI led to lasting responses
VB10.16 coupled with CPI led to lasting responses, both in RECIST responders and stabilized disease patients All (n = 47) Nykode Therapeutics | Q1 webcast | Non-confidential
Slide 24: VB10.16 led to prolonged overall survival in advanced cervical cancer patients
VB10.16 led to prolonged overall survival in advanced cervical cancer patients Median overall survival of 16.9 months in overall population, mOS not reached (> 25 months) in PD-L1+ patients Overall survival Overall survival (PD-L1+ vs. PD-L1-) mOS N.R. (> 25 months) mOS 16.9 months mOS 7.3 months No
Slide 25: VB10.16 induced HPV16-specific T cell responses correlated with clinical response
VB10.16 induced HPV16-specific T cell responses that are significantly correlated with clinical response HIGHER FOLD INCREASED T CELL HIGHER PEAK T CELL RESPONSES IN RESPONSES IN PATIENTS WITH DISEASE PATIENTS WITH DISEASE CONTROL CONTROL 1500 p=0.0113 50 p=0.0346 1000 500 SFU/106 PBMC250 10 Fold ch
Slide 26: VB10.16 Ph2 data compared with current and future SoC
Data from the VB10.16 Ph2 trial compared with relevant current and future SoC as evaluated in third-party trials Cemiplimab in PD-L1+ Tisotumab vedotin VB10.16 plus atezolizumab Pembrolizumab in PD-L1+ Endpoint (Empower-Cervical 1, (PD-L1 agnostic) in PD-L1+ (n = 24) (Keynote-158, n = 82)** n = 82,
Slide 27: C-02 data supports patient population selection for potentially registrational study
C-02 data supports patient population selection for potentially registrational study Clinical activity observed across all endpoints, with strongest results in PD-L1+ patients with 1 prior line of systemic therapy Duration of response data in PD-L1+ patients show potential for competitive positi
Slide 28: VB10.16 has broad potential across HPV-driven cancers
VB10.16 has broad potential across HPV-driven cancers FINALIZED. REPORTED ONGOING. REPORTED EXPANSION PLANNED FOR 2023 FURTHER POTENTIAL POSITIVE DATA POSITIVE INTERIM DATA C-01 C-02 C-03 Earlier lines Ph 1/2a Pre- C-04 Ph 2a Ph 1/2a Head and other cancerous Ph 2 Cervical Cervical and Neck HPV+ driv
Slide 29: VB10.16 with atezolizumab showed promising clinical profile with favorable tolerability
VB10.16 in combination with atezolizumab showed promising clinical profile with favorable tolerability in patients with advanced HPV16+ cervical cancer, an area of high unmet medical need Clinically relevant endpoint mPFS was 4.1, 6.3 and 16.9 months for all, PD-L1+ and PD-L1+ with one prior treat
Slide 30: Near term key inflection points for VB10.16
Near term key inflection points for VB10.16 Start of C-03 and C-04 trial C-03 C-04 Head and Cervical Neck Cancer Cancer Initiation 1H Initiation Q4 • PD-L1+ HPV16+ 1st line SCHNN patients • PD-L1+ HPV16+, recurrent or metastatic cervical • Combination with pembrolizumab cancer (Keytruda®) • Refracto
Slide 31: Financials
Financials
Slide 32: Strong financial foundation for achieving our vision
Strong financial foundation for achieving our vision Cash position of $186m end Q1 2023 Financially well positioned to grow and execute the Company’s strategy over the next years Published inaugural ESG report for 2022 Nykode continues to explore a potential listing on the Nasdaq Global Market
Slide 33: Income Statement
Income Statement Revenue from contracts with customers Amounts in USD ‘000 Q1 2023 Q1 2022 FY 2022 • R&D activities under Genentech and Regeneron Revenue from contracts with customers 3,126 716 7,168 agreements Other income 181 309 1,861 • $2.5m (Q1 2023) and $0.5m (Q1 2022) under Total revenue and
Slide 34: Balance Sheet
Balance Sheet Cash and cash equivalents Amounts in USD ‘000 31/03/2023 31/12/2022 • Strong cash position of $186m at March 31, 2023 ASSETS Non-current assets Trade receivables Property, plant and equipment 3,734 3,518 • Reduction due to receipt of $2.5m milestone under Right-of-use assets 6,302 6,00
Slide 35: Balance Sheet - contd.
Balance Sheet - contd. Amounts in USD ’000 31/03/2023 31/12/2022 Equity EQUITY AND LIABILITIES • Total equity of $148m as per March 31, 2023 Equity Share capital 339 338 • Equity ratio of 72% Share premium 84,145 83,318 Other capital reserves 12,469 11,695 Other components of equity (3,044) (3,044)
Slide 36: Rich calendar of milestones expected in the next months
Rich calendar of milestones expected in the next 12 months VB10.16 ✓ 1H 2023 Final results from VB-C-02 Phase 2 study; 12 month treatment follow-up Cervical Cancer 1H VB10.16 First patient dosed in C-03 trial with KEYTRUDA® in patients with PD-L1 positive 2023 1st line unresectable recurrent or meta
Slide 37: Unlocking the future of medicine
UNLOCKING THE FUTURE OF MEDICINE Contact: Agnete Fredriksen CBO IR@vaccibody.com Nykode Therapeutics | Q1 webcast | Non-confidential