Zelluna Asa · OSL:ZLNA
Zelluna Asa — Ultimovacs — Q3 2019 Earnings Presentation
16 slides from Zelluna Asa's earnings presentation, Nov 14, 2019
Slide 1: Activating the immune system to fight cancer – Third quarter 2019 presentation
Activating the immune system to fight cancer Third quarter 2019 presentation 14 November 2019 Øyvind Kongstun Arnesen, CEO Jens Bjørheim, CMO Hans Vassgård Eid, CFO | Strictly private and confidential
Slide 2: Important notice and Disclaimer
Important notice and Disclaimer This presentation may contain certain forward-looking statements and forecasts based on uncertainty, since they relate to events and depend on circumstances that will occur in the future and which, by their nature, will have an impact on Ultimovacs’ business, financia
Slide 3: Ultimovacs – brief overview
Ultimovacs – brief overview Ultimovacs is a research based pharmaceutical company focused on developing universal cancer vaccines applicable at all stages of cancer, including possibly prevention of cancer Ultimovacs’ lead product, UV1, is a universal cancer vaccine developed to enable the immune sy
Slide 4: UV1 is a CD4 Activating, Universal Cancer Vaccine
UV1 is a CD4 Activating, Universal Cancer Vaccine UV1 is directed towards hTERT, which is expressed in 85-90% of all cancer indications UV1 can be used in the general population without pre-screening of HLA The UV1 vaccine consists of long peptides activating CD4 helper T lymphocytes UV1 is easily m
Slide 5: Ultimovacs – Development Plan
Ultimovacs – Development Plan 2018 2019 2020 2021 2022 2023 Metastatic malignant melanoma trial (Phase I, N=20 (TBC: up to 30), UV1/pembrolizumab) Ultimovacs sponsored UV1 Phase II proof of concept trial (first line metastatic malignant Preparations melanoma with triple combination ipilimumab/nivolu
Slide 6: Highlights – Q3 2019
Highlights – Q3 2019 Clinical trial update Ongoing US based phase I trial study in malignant melanoma UV1 is given in combination with the PD-1 checkpoint inhibitor pembrolizumab All of the originally planned 20 patients have been included in this trial There have been no observed unexpected safety
Slide 7: Highlights – Q3 2019
Highlights – Q3 2019 Clinical trial update (cont.) Upcoming randomized phase II trial in malignant melanoma UV1 will be given in combination with the CTLA-4 checkpoint inhibitor ipilimumab and the PD-1 checkpoint inhibitor nivolumab Preparations are progressing according to plan towards inclusion of
Slide 8: Highlights – Q3 2019: Results from the completed trials
Highlights – Q3 2019 Results from the completed trials – in follow-up phase Overall Survival (OS)* Median OS mPFS** Clinical trial Year 1 Year 2 Year 3 Year 4 Year 5 (months) (months) Prostate (n=22) 95 % 86 % 73 % 55 % 50 % Not yet measurable n.a.*** NSCLC (n=18) 72 % 50 % 44 % 39 % H2-20 28.2 12.3
Slide 9: Highlights – Q3 2019: NSCLC 4 years OS
Highlights – Q3 2019 Results from the completed trials – in follow-up phase (cont.) NSCLC 4 years OS (presented at SITC) UV1 was well tolerated without any severe safety events UV1 induced a specific immune response in 67% of the patients Median overall survival was 28.2 months Four years overall su
Slide 10: CEO’s corner: How does immunotherapy and a cancer vaccine work?
CEO’s corner in the Q3 2019 report: ‘How does immunotherapy and a cancer vaccine work?’ The cancer immunity cycle8 Telomerase preserves telomers in cancer cells w/o telomerase enzyme w/ telomerase enzyme Cell division Cell division B Normal cell = Cancer cell = normal cell Unlimited, uncontrolled de
Slide 11: Key financials per Q3-2019 - Ultimovacs Group
Key financials Key financials per Q3-2019 - Ultimovacs Group NOK (000) Q3-18 Q3-19 YTD-18 YTD-19 FY18 Comments: Total revenues 0 0 0 0 0 Payroll expenses Payroll and payroll related expenses 9 454 8 653 19 937 11 474 27 078 Higher cost in Q3-18 than Q3-19 due to External R&D and IPR expenses 4 196 7
Slide 12: Key financials – operating cash flow
Key financials – operating cash flow NOK (000) Comments: Relatively stable operating cash flow per quarter, primarily affected by R&D activities Increase of personnel expenses during this period due to number of FTEs going from 10 to 17 Operating cash outflows expected to increase significantly from
Slide 13: Key financials – quarterly overview
Key financials – quarterly overview Key financials per Q3-2019 - Ultimovacs Group NOK (000) Q1-18 Q2-18 Q3-18 Q4-18 Q1-19 Q2-19 Q3-19 YTD-18 YTD-19 FY18 Total revenues 0 0 0 0 0 0 0 0 0 0 Payroll and payroll related expenses 6 355 4 128 9 454 7 141 7 538 -4 717 8 653 19 937 11 474 27 078 External R&
Slide 14: Expected near-term milestones
Expected near-term milestones Q1 2020 4-years OS data from malignant melanoma phase 1 (presentation expected February 2020) Q1 2020 Recruitment of patients completed in the ongoing US phase I trial Q1 2020 Initiation (first patient in) of the randomized phase II trial in malignant melanoma H1 2020 S
Slide 15: For questions
For questions Øyvind Kongstun Arnesen, CEO E-mail: oeyvind.arnesen@ultimovacs.com Phone: +47 469 33810 Hans Vassgård Eid, CFO E-mail: hans.eid@ultimovacs.com Phone: +47 469 19822 | 15 Strictly private and confidential
Slide 16: Q&A
Q&A | Strictly private and confidential