Zelluna Asa · OSL:ZLNA
Zelluna Asa — Ultimovacs — Q4 2019 Earnings Presentation
15 slides from Zelluna Asa's earnings presentation, Feb 14, 2020
Slide 1: Activating the immune system to fight cancer – Fourth quarter 2019 presentation
Activating the immune system to fight cancer Fourth quarter 2019 presentation 14 February 2020 Øyvind Kongstun Arnesen, CEO Jens Bjørheim, CMO Hans Vassgård Eid, CFO |
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: Significant expansion of the UV1 development program in Q4 2019
Significant expansion of the UV1 develoment program in Q4 2019 The INITIUM trial is progressing according to plan Randomized phase II trial in malignant melanoma Major expansion of the UV1 development program achieved 154 patients Two large randomized, fully First patient expected Q1 2020 funded pha
Slide 4: Ultimovacs – Development Plan
Ultimovacs – Development Plan 2018 2019 2020 2021 2022 2023 Phase I trial (first line metastatic malignant melanoma with combination UV1/pembrolizumab) Ultimovacs sponsored UV1 INITIUM: Phase II proof of concept trial (first line metastatic malignant melanoma with triple combination ipilimumab/nivol
Slide 5: Highlights – Q4 2019: Clinical trial update
Highlights – Q4 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 20 of the initially planned patients have been successfully included (cohort 1 – safety pembrolizumab/UV1) No unexpe
Slide 6: Highlights – Q4 2019: Clinical trial update (cont.)
Highlights – Q4 2019: Clinical trial update (cont.) The INITIUM trial (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 154 patients, first patient expected Q1 2020 The trial
Slide 7: Highlights – Q4 2019: Clinical trial update (cont.)
Highlights – Q4 2019: Clinical trial update (cont.) The NIPU trial (randomized phase II trial in malignant pleural mesothelioma) UV1 will be given in combination with the CTLA-4 checkpoint inhibitor ipilimumab and the PD-1 checkpoint inhibitor nivolumab 118 patients, first patient expected Q1 2020 T
Slide 8: Results from the completed trials – in follow-up phase
Highlights – Q4 2019: Results from the completed trials – in follow- up phase Overall Survival (OS)¹ Median OS mPFS² Clinical trial Year 1 Year 2 Year 3 Year 4 Year 5 (months) (months) Will be more than 60 Prostate (n=22) 95 % 86 % 73 % 55 % 50 % months n.a.³ NSCLC (n=18) 72 % 50 % 44 % 39 % H2-20 2
Slide 9: Results from the completed trials – in follow-up phase (cont.)
Highlights – Q4 2019: Results from the completed trials – in follow- up phase (cont.) Malignant melanoma – 4 years – presented at ASCO-SITC February 2020 UV1 given in combination with ipilimumab, 12 patients Treatment was generally well-tolerated Immune responses occurred very early and 10/11 (91%)
Slide 10: CEO’s corner: UV1 – a Universal cancer vaccine
CEO’s corner in the Q4 2019 report: ‘UV1 – a Universal cancer vaccine’ Being Universal Easy to combine with other immunotherapies Simple to manufacture and use Can be developed to prevent cancer | 10
Slide 11: Key financials
Key financials Key financials per Q4-2019 - Ultimovacs Group NOK (000) Q4-18 Q4-19 FY18 FY19 Comments: Total revenues 0 0 0 0 Payroll expenses Payroll and payroll related expenses 7 141 8 686 27 078 20 160 Higher cost in Q4-19 than Q3-18 due to External R&D and IPR expenses (incl. grants) 1 514 16 5
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 duri
Slide 13: Key financials – quarterly overview
Key financials – quarterly overview Key financials per Q4-2019 - Ultimovacs Group NOK (000) Q1-18 Q2-18 Q3-18 Q4-18 Q1-19 Q2-19 Q3-19 Q4-19 FY18 FY19 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 8 686 27 078 20 160 External R&D an
Slide 14: 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 | 14
Slide 15: Q&A
Q&A |