Zelluna Asa · OSL:ZLNA
Zelluna Asa — Ultimovacs — Q3 2020 Earnings Presentation
24 slides from Zelluna Asa's earnings presentation, Nov 12, 2020
Slide 1: Activating the immune system to fight cancer – Third quarter 2020 presentation
Activating the immune system to fight cancer Third quarter 2020 presentation 12 November 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 Q3 2020
Highlights Q3 2020 The Phase II INITIUM trial (metastatic malignant melanoma): twelve patients enrolled (vs. three after Q2 2020) The Phase II NIPU trial (mesothelioma): six patients enrolled (vs. four after Q2 2020) The Covid-19 pandemic has so far had limited impact regarding site openings and pat
Slide 4: Highlights Q3 2020 (cont.)
Highlights Q3 2020 (cont.) Positive signals of clinical efficacy in two Phase I trials: In the fully enrolled US-based Phase I trial in malignant melanoma where UV1 is combined with pembrolizumab, 12-month overall survival (OS) in the first cohort of 20 patients was announced in September 2020 Five-
Slide 5: Highlights Q3 2020 (cont.)
Highlights Q3 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 Finalization of the agreement and announc
Slide 6: 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 7: A third Phase II clinical trial – non-disclosed indication
A third Phase II clinical trial – non-disclosed indication In May 2020, Ultimovacs announced the collaboration with a leading large pharma company and a European oncology clinical trial group to evaluate the Company's universal cancer vaccine, UV1, in an additional randomized, multi-center Phase II
Slide 8: 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 9: The INITIUM trial (randomized phase II trial in malignant melanoma)
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 Europe (including Norway) Appr. 40 sites (hospita
Slide 10: The NIPU trial (randomized phase II trial in malignant pleural mesothelioma)
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. Åslaug Helland at Oslo University Hospital, Norway
Slide 11: Ongoing US based phase I trial study in malignant melanoma
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 fully enrolled (as previously reported) Positive topline results from the first cohort of 20 patients 12-months overall survival (OS) rate of 85% Media
Slide 12: Results from the completed trials in follow-up phase – Five-year overall survival data
Results from the completed trials in follow-up phase – Five-year overall survival data from the Phase I trial NSCLC Overall Survival (OS)¹ Median OS mPFS² Clinical trial⁴ 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 % 4
Slide 13: TENDU Phase I clinical trial and the TET-platform
TENDU Phase I clinical trial and the TET-platform TENDU Phase I clinical trial The regulatory approval is now in place to start the Phase I TENDU trial. This trial will investigate a prostate cancer specific vaccine based on the TET technology. First patient is expected in Q1 2021 The TENDU trial wi
Slide 14: TENDU Phase I clinical trial and the TET-platform (cont.)
TENDU Phase I clinical trial and the TET-platform (cont.) Development of new vaccines based on the TET technology platform Pending confirmation of the safety of the TET technology and results from ongoing and further pre-clinical development of the TET platform, the ambition is to identify new cance
Slide 15: Financial position
Financial position Total cash end of Q3 2020 amounted to MNOK 453.5 As expected, the negative cash-flow from operations has increased significantly in YTD-20, due to the ramp-up of the R&D activities with the initiation the Phase II trials However, the increase in R&D costs in Q3/H2 2020 is lower th
Slide 16: Key financials
Key financials Key financials per Q3-2020 - Ultimovacs Group Comments: NOK (000) Q3-19 Q3-20 YTD-19 YTD-20 FY19 Payroll expenses Total revenues 0 0 0 0 0 Payroll and payroll related expenses 8 653 13 115 11 474 36 327 20 160 Higher cost in Q3/YTD-20 than same periods External R&D and IPR expenses (i
Slide 17: Key financials – operating cash flow
Key financials – operating cash flow NOK (000) Comments: Following relatively stable operating cash flow per quarter, the negative cash flow has increased significantly in 2020 due to higher R&D activities (as planned) A further increase in operating costs related to R&D should be expected in Q4-20
Slide 18: Key financials – quarterly overview
Key financials – quarterly overview Key financials per Q3-2020 - Ultimovacs Group NOK (000) Q1-19 Q2-19 Q3-19 Q4-19 Q1-20 Q2-20 Q3-20 FY19 Total revenues 0 0 0 0 0 0 0 0 Payroll and payroll related expenses 7 538 -4 717 8 653 8 686 10 015 13 197 13 115 20 160 External R&D and IPR expenses (incl. gra
Slide 19: Expected newsflow 2020-2021
Expected newsflow 2020-2021 2020 2021 Q4 Q1 Q2 Q3 Q4 Signed agreements on First patient in – the third Phase II the third Phase II trial trial 1 and 2-year 5-years overall observation of survival data safety and efficacy from malignant in Cohort 1 and 2 in melanoma the ongoing US phase I trial phase
Slide 20: Key take-aways
Key take-aways 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 Broad Phase II development program – 3 trials with more than 400 patients (on top of th
Slide 21: 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 | 21
Slide 22: Q&A
Q&A |
Slide 23: Regulatory Pathway and Partnering Activities – UV1
Regulatory Pathway and Partnering Activities – UV1 Key value inflection point(s) Business Development In a Partnership Preparatory Active Phase II – Reg. Pre- Reg. Reg. Reg. Phase III - clinical review Phase I review proof of review pivotal review Commercialization concept - NDA INITIUM - FDA/ EMA E
Slide 24: Regulatory Pathway and Partnering Activities – UV1
Regulatory Pathway and Partnering Activities – UV1 Business Development In a Partnership Preparatory Active Phase II – Reg. Phase III - proof of Reg. review review Commercialization pivotal - NDA concept INITIUM - What if the Phase II data is very positive? FDA/ EMA End of approval Phase II - Ultimo