Nykode Therapeutics Asa · OSL:NYKD
Nykode Therapeutics Asa — Q3 2023 Earnings Presentation
27 slides from Nykode Therapeutics Asa's earnings presentation, Nov 15, 2023
Slide 1: Q3 2023 Results Presentation
Q3 2023 Results Presentation November 15, 2023
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 | Q3 webcast | Non-confidential
Slide 4: Delivering on our long-term strategy (1/3)
Delivering on our long-term strategy (1/3) VB10.16 progressing towards patients & markets and broadening therapeutic scope • FDA IND approved for VB-C-04 trial investigating VB10.16 in combination with atezolizumab in 2nd line HPV16-positive recurrent or metastatic cervical cancer patients • Initiat
Slide 5: Delivering on our long-term strategy (2/3)
Delivering on our long-term strategy (2/3) Progressing Regeneron partnership • Preclinical data generated by Regeneron demonstrating that Nykode’s APC targeting vaccines induce potent T cell responses against targets subject to central tolerance Tolerance platform – a new therapeutic vertical in Nyk
Slide 6: Delivering on our long-term strategy (3/3)
Delivering on our long-term strategy (3/3) Solid financial position, broadening and strengthening international shareholder base • $159.1m at September 30, 2023 (pre private placement) • Successful private placement of $45m which saw significant international investor participation Other • Norwegian
Slide 7: Rich and diversified pipeline
Rich and diversified pipeline Upcoming Asset Indication Rights Preclinical Phase 1 Phase 2 Phase 3 Catalyst Oncology 1 Initiate trial HPV16+ cervical cancer (Q4 2023) 2 Dose level VB10.16 HPV16+ head and neck cancer recommendation (H2 2024) 2 Off-the-shelf HPV16+ locally advanced Protocol in cervica
Slide 8: R&D update
R&D update Nykode Therapeutics | Q3 webcast | Non-confidential
Slide 9: Nykode’s vaccine induces a rapid, robust and long-lasting CD8 T cell response
Nykode’s vaccine induces a rapid, robust and long-lasting CD8 T cell response against cancer cells MECHANISM OF ACTION – T CELL INDUCTION Nykode Therapeutics | Q3 webcast | Non-confidential 9
Slide 10: 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 11: 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 in Pembrolizumab in Cemiplimab in Tisotumab vedotin Endpoint atezolizumab PD-L1+††† PD-L1+** PD-L1+ †† (PD-L1 agnostic) ‡ ‡ in PD-L1+ Skyscraper
Slide 12: T cell responses remain strong and long-lasting
T cell responses remain strong and long-lasting RAPID AND PERSISTENT EXPANSION OF T CELL CLONES Additional analysis from the VB-C-02 trial supporting a differentiated long-lasting immune response correlating with clinical efficacy • Rapid and persistent on-treatment T cell expansion • Peak expansi
Slide 13: Maximizing shareholder value by diversifying offerings and broadening therapeutic scope
Maximizing shareholder value by diversifying offerings and broadening therapeutic scope Building a cancer vaccine franchise following strong clinical validation Validation Today Future Opportunities Adjuvant Settings Move earlier to expand patient population and Indication Expansions explore long-te
Slide 14: Creating a portfolio of targeted vaccines for HPV16+ cancers
Creating a portfolio of targeted vaccines for HPV16+ cancers VB10.16 portfolio C-02 C-03 C-04 C-05 r/m head and neck r/m Cervical Cancer, ≥2L r/m Cervical Cancer, Locally Advanced Indication cancer (HNSCC), PD-L1+, 2L Cervical Cancer (LACC) PD-L1+, 1L Up to 9 mg in 3 mg in combination with combinati
Slide 15: VB10.NEO: leading technology for individualized cancer neoantigen immunotherapy
VB10.NEO: leading technology for individualized cancer neoantigen immunotherapy Pioneering neoantigen research Trained on Nykode’s data and unique broad CD8 dominated immune response Broad vaccine-specific T cells in all patients DURABLE NEO-AG SPECIFIC T CELL RESPONSES Durable T cell response
Slide 16: VB10.NEO programs
VB10.NEO programs Safety clearance of 9 mg dose with no safety concerns and no dose limiting toxicities observed N-01 N-02 r/m Melanoma, non-small cell lung cancer (NSCLC), clear renal cell carcinoma, urothelial Indication r/m cancer, covering more than ten indications cancer or squamous cell carcin
Slide 17: Induction of antigen specific tolerance by targeting 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 DNA plasmid vaccine CD4+ Treg Tol APC CD4+ Treg Tol APC Effector T Effector T cell cell Cells encod
Slide 18: Unique Ag-specific inverse vaccine platform to treat Autoimmunity
Unique Ag-specific inverse vaccine NYKODE’S INVERSE VACCINES platform to treat Autoimmunity EAE ✱✱✱ 4 ✱✱ 80 3 EAE score 60 • Proprietary APC-targeted inverse vaccine platform generates AUC (5-29) 2 40 antigen-specific (Ag-specific) regulatory T cells, offering a unique 1 20 approach to treating auto
Slide 19: Nykode’s APC targeting leads to faster, stronger and broader T cell responses
NYKODE’S TECH IMPROVES Nykode’s APC targeting leads to faster, MRNA VACCINES stronger and broader T cell responses • Preclinical data shows that using APC targeted neoepitope vaccines with mRNA-LNP, whether delivered via DNA or mRNA, leads to stronger and broader T cell responses. • Nearly doubled n
Slide 20: Q3 2023 Financial Results
Q3 2023 Financial Results
Slide 21: Strong financial foundation for achieving our vision
Strong financial foundation for achieving our vision Cash position of $159m end Q3 2023 Financially well positioned to execute the Company’s strategy over the next years Nykode continues to explore a potential listing on the Nasdaq Global Market in the United States Nykode Therapeutics | Q3 webc
Slide 22: Subsequent events
Subsequent events Private placement Tax matter Norwegian Tax Authorities (NTA) reiterated Successfully raised $45m in private placement their position that upfront payments received Aim to broaden the existing shareholder base under a license agreement entered into in with international invest
Slide 23: Income Statement
Income Statement Revenue from contracts with customers Amounts in USD ‘000 Q3 2023 Q3 2022 YTD 2023 YTD 2022 • R&D activities under Genentech and Regeneron Revenue from contracts with customers 2,760 648 10,886 4,478 agreements Other income 51 634 332 1,251 • $2.6m (Q3 2023) and $10.1m (YTD 2023) un
Slide 24: Balance Sheet
Balance Sheet Cash and cash equivalents Amounts in USD ‘000 30/09/2023 31/12/2022 • Strong cash position of $159m at September 30, ASSETS 2023 Non-current assets Property, plant and equipment 4,535 3,517 Right-of-use assets 6,502 6,009 Trade receivables Intangible assets 67 32 • Reduction due to rec
Slide 25: Balance Sheet - contd.
Balance Sheet - contd. Amounts in USD ’000 30/09/2023 31/12/2022 Equity EQUITY AND LIABILITIES • Total equity of $130m as per September 30, 2023 Equity Share capital 339 338 • Equity ratio of 75% Share premium 84,145 83,318 Other capital reserves 13,924 11,694 Other components of equity (3,007) (3,0
Slide 26: Upcoming milestones
Upcoming milestones Q4 VB10.16 Initiate potentially registrational VB-C-04 trial in the U.S. in patients with 2023 Cervical Cancer recurrent/metastatic disease and PD-L1 positive tumors Q4 Undisclosed Nomination of an additional oncology development candidate for a new internal 2023 Oncology oncolog
Slide 27: Unlocking the future of medicine
UNLOCKING THE FUTURE OF MEDICINE Contact: Alexandra Deschner Head of Investor Relations IR@nykode.com Nykode Therapeutics | Q3 webcast | Non-confidential