Zelluna Asa · OSL:ZLNA
Zelluna Asa — Ultimovacs — Q2 2020 Earnings Presentation
21 slides from Zelluna Asa's earnings presentation, Aug 21, 2020
Slide 1: Activating the immune system to fight cancer – Second quarter 2020 presentation
Activating the immune system to fight cancer Second quarter 2020 presentation 21 August 2020 Carlos de Sousa, 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: Highlights Q2 2020
Highlights Q2 2020 The Phase II INITIUM trial (metastatic malignant melanoma): three patients enrolled The Phase II NIPU trial (mesothelioma): four patients enrolled The ongoing Phase I trial in malignant melanoma, is fully recruited as of this week (30 patients). No unexpected safety issues have be
Slide 4: Highlights Q2 2020 (cont.)
Highlights Q2 2020 (cont.) A third Phase II clinical trial was announced in May 2020: Collaboration with a non-specified large pharma company and a leading European oncology clinical trial group UV1 will be evaluated in a new indication and a new combination More information is planned to be disclos
Slide 5: Broad Development Pipeline
Broad Development Pipeline Platform / Partner / Indication Clinical trial information Preclinical Phase I Phase II Phase III candidate Collaboration Conducted at OUS, 22 patients. Completed in Prostate 2015 Non-small cell lung Conducted at OUS, 18 patients. Completed in cancer (NSCLC) 2016 Metastati
Slide 6: Ultimovacs – Extensive Development Plan
Ultimovacs – Extensive 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 ipilim
Slide 7: Highlights – Q2 2020: Clinical trial update
Highlights – Q2 2020: Clinical trial update 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 in total The trial will be run in the US and Europ
Slide 8: Highlights – Q2 2020: Clinical trial update (cont.)
Highlights – Q2 2020: 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 in total Lead investigator is Dr.
Slide 9: Highlights – Q2 2020: Clinical trial update (cont.)
Highlights – Q2 2020: Clinical trial update (cont.) A third Phase II clinical trial – non-disclosed indication In May 2020, Ultimovacs announced the collaboration with a leading big pharma company and a European oncology clinical trial group to evaluate the Company's universal cancer vaccine, UV1, i
Slide 10: Highlights – Q2 2020: Clinical trial update (cont.)
Highlights – Q2 2020: Clinical trial update (cont.) Ongoing US based phase I trial study in malignant melanoma UV1 is given in combination with the PD-1 checkpoint inhibitor pembrolizumab The trial is now fully enrolled Cohort 1 – safety pembrolizumab/UV1 – 20 patients In September 2020, all patient
Slide 11: Results from the completed trials – in follow-up phase
Highlights – Q2 2020: Results from the completed trials – in follow- up phase Overall Survival (OS)¹ Median OS mPFS² Clinical trial⁵ Year 1 Year 2 Year 3 Year 4 Year 5 (months) (months) Prostate (n=22) 95 % 86 % 73 % 55 % 50 % 61.8 n.a.³ NSCLC (n=18) 72 % 50 % 44 % 39 % Q4-20 28.2 10.7⁴ Will be more
Slide 12: Highlights – Q2 2020: The TET-platform and TENDU
Highlights – Q2 2020: The TET-platform and TENDU The TET platform In July 2018, Ultimovacs acquired the former immunotherapy technology business of Immuneed AB The core technology is the proprietary and patent-protected Tetanus-Epitope Targeting- platform (the ‘TET-platform’), a promising approach t
Slide 13: Highlights – Q2 2020: The TET-platform and TENDU (cont.)
Highlights – Q2 2020: The TET-platform and TENDU (cont.) TENDU Phase I clinical trial to test the safety of the TET technology Ultimovacs is now preparing for a Phase I trial to test the TET technology in prostate-cancer patients. Expected to start before the end of this year The main objective is t
Slide 14: Financial position
Financial position Significantly oversubscribed private placement in May 2020 Share issue done ‘at market’ – NOK 38.90 per share Gross proceeds of MNOK 160, net proceeds of MNOK 153 Total cash end of Q2 2020 amounted to MNOK 482 Based on current development plan and timeline, the existing funding is
Slide 15: Key financials
Key financials Comments: Key financials per Q2-2020 - Ultimovacs Group NOK (000) Q2-19 Q2-20 YTD-19 YTD-20 FY19 Payroll expenses Total revenues 0 0 0 0 0 Higher cost in Q2/YTD-20 than same periods prior Payroll and payroll related expenses -4 717 13 197 2 821 23 212 20 160 year due to: External R&D
Slide 16: Key financials – operating cash flow
Key financials – operating cash flow NOK (000) Comments: Following relatively stable operating cash flow per quarter, the cash burn has increased significantly in 2020 due to higher R&D activities (as planned) A further increase in operating costs should be expected in 2H 2020 Increase of personnel
Slide 17: Key financials – quarterly overview
Key financials – quarterly overview Key financials per Q2-2020 - Ultimovacs Group NOK (000) Q1-19 Q2-19 Q3-19 Q4-19 Q1-20 Q2-20 Total revenues 0 0 0 0 0 0 Payroll and payroll related expenses 7 538 -4 717 8 653 8 686 10 015 13 197 External R&D and IPR expenses (incl. grants) 4 665 4 909 6 766 16 598
Slide 18: Expected newsflow 2020-2021
Expected newsflow 2020-2021 2020 2021 Q3 Q4 Q1 Q2 Q3 Q4 Signed First patient in – agreements on the third Phase II the third Phase II trial trial 1-year observation 1 and 2-year Completion of of safety and observation of patient enrollment efficacy in Cohort safety and efficacy (30 patients) in the
Slide 19: Key take-aways and outlook
Key take-aways and outlook Universal vaccine technology (UV1 and TET) broadly applicable in different cancer types and in different therapeutic combinations Good safety profile and early positive signals of clinical efficacy Strong platform for Broad Phase II development program – 3 trials with more
Slide 20: For questions
For questions Carlos de Sousa, CEO E-mail: carlos.desousa@ultimovacs.com Phone: +47 908 92507 Hans Vassgård Eid, CFO E-mail: hans.eid@ultimovacs.com Phone: +47 482 48632 | 20
Slide 21: Q&A
Q&A |