Zelluna Asa · OSL:ZLNA
Zelluna Asa — Ultimovacs — Q4 2020 Earnings Presentation
33 slides from Zelluna Asa's earnings presentation, Feb 17, 2021
Slide 1: Enabling the immune system to fight cancer - Fourth quarter 2020 presentation
Enabling the immune system to fight cancer Fourth quarter 2020 presentation 17 February 2021 Carlos de Sousa, CEO Jens Bjørheim, CMO Hans Vassgård Eid, CFO Non-Confidential, Ultimovacs copy and distribution rights 1
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: Table of contents
Table of contents Highlights Q4 2020 Operational update Q4 2020 Key financials Q4 2020 & newsflow Intellectual Property Rights (IPR) Non-Confidential, Ultimovacs copy and distribution rights 3
Slide 4: Highlights Q4 2020
Highlights Q4 2020 UV1 Phase II program extended from two to four trials – more than 500 patients to be enrolled • The DOVACC trial: • Collaboration study with NSGO-CTU, ENGOT and AstraZeneca • Ovarian cancer • UV1, durvalumab and Olaparib • 184 patients • The FOCUS trial: • Collaboration with Unive
Slide 5: Highlights Q4 2020 (cont.)
Highlights Q4 2020 (cont.) Ongoing patient recruitment in the INITIUM and NIPU trials • INITIUM: 24 out of 154 patients enrolled (12 enrolled as of Q3 2020) • NIPU: 18 out of 118 patients enrolled (6 enrolled as of Q3 2020) Covid-19 impact • The Company is actively monitoring the COVID-19 pandemic r
Slide 6: Highlights Q4 2020 (cont.)
Highlights Q4 2020 (cont.) Read-out of 5-year overall survival in two Phase I trials • Safety confirmed • Encouraging signals of long-term survival benefit New Chief Business Officer position • Ton Berkien joined as Chief Business Officer from December 2020 Non-Confidential, Ultimovacs copy and dist
Slide 7: Highlights Q4 2020 (cont.)
Highlights Q4 2020 (cont.) Paper published in “Frontiers in Immunology” • Based on positive long-term follow-up data from UV1 Phase I trial in non-small cell lung cancer Significant public grants obtained for Phase II trials • Public grants of up to MNOK 26 obtained from Innovation Norway and the No
Slide 8: Table of contents
Table of contents Highlights Q4 2020 Operational update Q4 2020 Key financials Q4 2020 & newsflow Intellectual Property Rights (IPR) Non-Confidential, Ultimovacs copy and distribution rights 8
Slide 9: Broad Development Pipeline: more than 500 patients in Phase II
Broad Development Pipeline: more than 500 patients in Phase II Indication Clinical trial information Preclinical Phase I Phase II Phase III Partner/Collaboration Prostate cancer Conducted at OUS, 22 patients. Completed in 2015 Oslo University Hospital Non-small cell lung cancer Conducted at OUS, 18
Slide 10: DOVACC and FOCUS are newly initiated Phase II trials
DOVACC and FOCUS are newly initiated Phase II trials DOVACC FOCUS • Randomized Phase II second maintenance trial in BRCA negative • Randomized phase II trial in patients with recurrent or ovarian cancer patients metastatic PDL1 positive head and neck cancer • Sponsored by NSGO/ENGOT in collaboration
Slide 11: INITIUM and NIPU are ongoing Phase II trials
INITIUM and NIPU are ongoing Phase II trials INITIUM NIPU • Randomized Phase II trial in 1st line treatment of patients with • Randomized Phase II trial in 2nd line malignant pleural mesothelioma metastatic malignant melanoma • Sponsored by Oslo University Hospital in collaboration with BMS • Ultimo
Slide 12: Three Phase I trials are completed with 5-year follow-up
Three Phase I trials are completed with 5-year follow-up Good safety profile and signals of clinical efficacy observed (compared to historical controls) Clinical Trial¹ Ultimovacs Trials Historical Comparison5 Overall Survival Median OS Median PFS Overall Survival Median OS Median PFS (OS) - Year 5²
Slide 13: Ongoing Phase I trial in first line malignant melanoma with pembrolizumab
Ongoing Phase I trial in first line malignant melanoma patients in combination with pembrolizumab • Ultimovacs sponsored study running in the US • Patient enrolment completed Q3 2020 • Cohort 1 • 20 patients • 1 year follow up in Sep-2020: UV1 UV1 • Overall survival (OS) rate was 85% (37.5 µg GM-CSF
Slide 14: The TET-platform and the TENDU trial
The TET-platform and the TENDU trial The TET-platform (Tetanus-Epitope Targeting) • Next-generation vaccine technology expanding Ultimovacs’ product pipeline • Promising approach to strengthen and increase T cell responses against cancer-specific peptides by combining antigens and the vaccine adjuva
Slide 15: The TET-platform and the TENDU trial (cont.)
The TET-platform and the TENDU trial (cont,) The TENDU Phase I trial • This trial will investigate a prostate cancer specific vaccine based on the TET technology • The TENDU trial will be conducted at Oslo University Hospital • 9-12 patients will be enrolled • This Phase I trial will provide valuabl
Slide 16: Table of contents
Table of contents Highlights Q4 2020 Operational update Q4 2020 Key financials Q4 2020 & newsflow Intellectual Property Rights (IPR) Non-Confidential, Ultimovacs copy and distribution rights 16
Slide 17: Financial position
Financial position • Total cash end of Q4 2020 amounted to MNOK 441 • As expected, the negative cash-flow from operations has increased significantly in FY20, 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 Q4 / 2020 is lower t
Slide 18: Key financials per Q4-2020 - Ultimovacs Group
Key financials Key financials per Q4-2020 - Ultimovacs Group Comments: NOK (000) Q4-19 Q4-20 FY19 FY20 Payroll expenses Total revenues - - - - Higher cost in Q4/FY20 than same periods previous Payroll and payroll related expenses 8 686 14 662 20 160 50 989 year due to: External R&D and IPR expen
Slide 19: Key financials – operating cash flow
Key financials – operating cash flow NOK (000) Comments: • Following relatively stable operating cash flow per quarter in FY19, 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 expect
Slide 20: Key financials – quarterly overview
Key financials – quarterly overview Key financials per Q4-2020 - Ultimovacs Group NOK (000) Q1-19 Q2-19 Q3-19 Q4-19 Q1-20 Q2-20 Q3-20 Q4-20 Total revenues - - - - - - - - Payroll and payroll related expenses 7 538 -4 717 8 653 8 686 10 015 13 197 13 115 14 662 External R&D and IPR expenses (incl. gr
Slide 21: Recent and expected newsflow 2020-2021
Recent and expected newsflow 2020-2021 2020 2021 Q4 Q1 Q2 Q3 Q4 Signed agreements on the First patient in the DOVACC Phase II trial DOVACC Phase II trial FOCUS First patient in the FOCUS trial 5-years overall 1 and 2-year observation survival data from of safety and efficacy in malignant melanoma Co
Slide 22: Table of contents
Table of contents Highlights Q4 2020 Operational update Q4 2020 Key financials Q4 2020 & newsflow Intellectual Property Rights (IPR) Non-Confidential, Ultimovacs copy and distribution rights 22
Slide 23: General patent application process
General patent application process Non-Confidential, Ultimovacs copy and distribution rights 23
Slide 24: General patent application process - Silent Period
General patent application process Silent Period Non-Confidential, Ultimovacs copy and distribution rights 24
Slide 25: Rights protecting pharmaceutical products in the EU
Rights protecting pharmaceutical products in the EU Patents • 20 year duration • Extension terms on patents: up to 5 additional years via Supplementary Protection Certificates (SPC) (+0.5 years via paediatric extension (PED)) Regulatory Data Protection • 8 years of protection of data filed in suppor
Slide 26: Rights protecting biological products in the US
Rights protecting biological products in the US Patents • 20 years from filing • Extension terms on patents: • Patent term extension (PTE) – to compensate for delays caused by FDA • Up to 5 years or up to 14 years from FDA approval (+ 0.5 years via paediatric exclusivity (PED)) Regulatory Data Prote
Slide 27: Eligible subject matter
Eligible subject matter With a focus on Europe • Examples of potentially patentable inventions include: • New chemical entities, compositions, formulations, combinations (i.e. compositions of matter) • 1st medical use, 2nd and subsequent medical uses • Dosage regimes • Ex vivo diagnostic methods • M
Slide 28: Options to extend patent terms
Options to extend patent terms Europe • Supplementary Protection Certificate (SPC) • Up to 5 additional years via SPC (additional 6 months via paediatric extension) • Aim of SPCs is to compensate the patentee for the patent term “lost” while obtaining regulatory approval USA • Patent Term Extension
Slide 29: Main UV1 patent (as example)
Main UV1 patent (as example) Patent / Priority Status Area covered Geographic area Expiry date Expiry date (extended) Assignee patent date (unextended) application EP10250265.5 16 Feb Granted/ UV1 composition of Patent granted in EPO, 2031 Up until 15 February Ultimovacs 2010 pending matter, the nuc
Slide 30: Summary of exclusivities in the US
Summary of exclusivities in the US PATENT PROTECTION Patent term, 20 years PTA, varies PTE, ≤5 y PED 0 10 20 30 Filing PED 12 years PED BIOLOGICS DATA, 4 y MARKET 0 12 BLA Approval No biosimilar EXCLUSIVITY can be approved 7 years PED ORPHAN DRUG 0 7 BLA Approval Product manufacturing process know-h
Slide 31: Key take-aways from Q4 report
Key take-aways from Q4 report • UV1 Phase II program extended from two to four trials – more than 500 patients to be enrolled • Patient recruitment in the INITIUM and NIPU trials is proceeding despite COVID-19 challenge • Read-out of 5-year overall survival in two Phase I trials shows encouraging re
Slide 32: Q&A
Q&A
Slide 33: Enabling the immune system to fight cancer - For questions
Enabling the immune system to fight cancer For questions Carlos de Sousa, CEO Hans Vassgård Eid, CFO carlos.desousa@ultimovacs.com hans.eid@ultimovacs.com +47 908 92507 +47 482 48632 www.ultimovacs.com