Zelluna Asa · OSL:ZLNA
Zelluna Asa — Ultimovacs — Q2 2022 Earnings Presentation
25 slides from Zelluna Asa's earnings presentation, Aug 19, 2022
Slide 1: Enabling the Immune System to Fight Cancer
Enabling the Immune System to Fight Cancer Second Quarter 2022 Presentation 19 August 2022 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: Table of Contents
Table of Contents Highlights Q2 2022 Operational Update Q2 2022 Key financials Q2 2022 & Newsflow 3 Non-Confidential, Ultimovacs copy and distribution rights
Slide 4: Highlights Q2 2022 – continued strong progress towards key milestones
Highlights Q2 2022 – continued strong progress towards key milestones • INITIUM and NIPU on track to expected topline readout during H1 2023 with good patient enrollment • Patient enrollment in INITIUM completed in June 2022 • Continued good patient enrollment in NIPU • Patient enrollment in FOCUS o
Slide 5: Highlights Q2 2022 – continued strong progress towards key milestones
Highlights Q2 2022 – continued strong progress towards key milestones • Continued presentation of valuable data to the medical and scientific community • Publication of long-term follow-up data on UV1 in the Journal for ImmunoTherapy of Cancer (JITC) • Poster presentation at the Cancer Immunotherapy
Slide 6: Table of Contents
Table of Contents Highlights Q2 2022 Operational Update Q2 2022 Key Financials Q2 2022 & Newsflow 6 Non-Confidential, Ultimovacs copy and distribution rights
Slide 7: Broad Phase II UV1 Pipeline with >650 Patients
Broad Phase II UV1 Pipeline with >650 Patients Expected Indication Clinical trial information topline Phase I Phase II Phase III Contributors readout UV1-103 With pembrolizumab Malignant melanoma - 30 patients INITIUM With ipilimumab & nivolumab Malignant melanoma H1 2023 156 patients NIPU With ipil
Slide 8: UV1-103 trial: Phase I UV1 + pembrolizumab in Malignant Melanoma
UV1-103 trial: Phase I UV1 + pembrolizumab in Malignant Melanoma Encouraging 2-year OS data vs. historical pembrolizumab data (all 30 patients reported) Overall Survival at 12 and 24 months – All 30 patients Topline readout from Phase I trial in malignant melanoma compared to historical pembrolizuma
Slide 9: INITIUM fully enrolled
INITIUM fully enrolled • Patient recruitment completed in 24 months, despite the challenges caused by the pandemic • 156 patients in total (2 more than targeted) • Running at 39 hospitals in 4 countries in the USA and Europe • On track to expected topline readout during H1 2023 • Event-driven trial
Slide 10: NIPU – enrollment on track
NIPU – enrollment on track • 92 out of 118 patients enrolled, compared to 78 patients in the Q1 2022 report • On track to expected topline readout during H1 2023 • Event-driven trial – readout after progression of cancer or death has been observed in a total of 69 patients • Readout expected during
Slide 11: DOVACC – administrative and regulatory processes have taken longer than expected
DOVACC – administrative and regulatory processes have taken longer than expected • Patient enrollment started in the first hospital in December 2021 • A total of 6 out of 184 patients have been enrolled, compared to 4 patients in the Q1 2022 report • The investigators have been preparing for initiat
Slide 12: FOCUS – patient enrollment on track
FOCUS – patient enrollment on track • 27 out of 75 patients enrolled, compared to 18 patients in the Q1 2022 report • Landmark trial – readout will take place 6 months after last patient is enrolled Non-Confidential, Ultimovacs copy and distribution rights 12
Slide 13: LUNGVAC – all preparations completed, patients in screening
LUNGVAC – all preparations completed, patients in screening • All preparations for initiation of patient recruitment are completed • Patients are currently being screened • The first patient is expected to be enrolled during Q3 2022 • Event-driven trial Non-Confidential, Ultimovacs copy and distribu
Slide 14: Scientific publications and presentations – UV1
Scientific publications and presentations – UV1 • On 27-30 October 2022, a trial-in progress poster giving an overview of the DOVACC trial will be presented at the European Society of Gynaecological Oncology (ESGO) 2022 Congress in Berlin, Germany. • In May 2022, Ultimovacs announced the publication
Slide 15: TET Technology Platform and the TENDU Phase I Trial
TET Technology Platform and the TENDU Phase I Trial • The TENDU trial investigates a prostate cancer specific vaccine based on the TET technology ‐ Conducted at Oslo University Hospital ‐ Nine patients enrolled as of Q2 2022 reporting, three in each of the three dosing cohorts ‐ The Drug Safety Moni
Slide 16: Table of Contents
Table of Contents Highlights Q2 2022 Operational Update Q2 2022 Key Financials Q2 2022 & Newsflow 16 Non-Confidential, Ultimovacs copy and distribution rights
Slide 17: Key Financials Q2 2022
Key Financials Q2 2022 Operating expenses Q2-22 and YTD-22 lower than expected, mainly due to R&D costs being incurred later than expected Total cash of MNOK 486 (~ EUR47M | USD49M) by the end of Q2 2022 Expected financial runway to the first half of 2024 (unchanged guiding) Non-Confidential, Ultimo
Slide 18: Key financials
Key financials Comments: Payroll expenses Key financials per Q2-2022 - Ultimovacs Group ▪ Approximately same level in both Q2 2021 and 2022, and YTD 2021 NOK (000) Q2-21 Q2-22 YTD21 YTD22 FY21 and 2022 Total revenues - - - - - Payroll and payroll related expenses 14 514 14 340 26 716 25 724 61 916 ▪
Slide 19: Key financials – quarterly operating cash flow
Key financials – quarterly operating cash flow NOK (000) – Negative amounts Comments: • After steadily increasing negative operating cash flows since Q2-21, the negative operating cash flow in Q2-22 was lower than the last few quarters • Operating expenses have been lower in both Q1 and Q2 2022 comp
Slide 20: Key financials – quarterly overview
Key financials – quarterly overview Key financials per Q2-2022 - Ultimovacs Group NOK (000) Q1-21 Q2-21 Q3-21 Q4-21 Q1-22 Q2-22 Total revenues - - - - - - Payroll and payroll related expenses 12 203 14 514 23 314 11 885 11 384 14 340 External R&D and IPR expenses (incl. grants) 16 012 20 588 16 031
Slide 21: Expected News Flow and Milestones: Key value inflection points during the next 12-24 months
Expected News Flow and Milestones: Key value inflection points during the next 12-24 months H1 2022 H2 2022 2023 2024 Phase I, UV1–103 Phase I, UV1–103 MALIGNANT Q3: 2-yr OS update Q4: Cohort 1, MELANOMA (all 30 patients) 3-yr OS update Phase II, INITIUM Phase II, INITIUM Q2: Enrollment H1: Topline
Slide 22: Investor Days: “Meet the Team” in Oslo, September 6th 2022
Investor Days: “Meet the Team” in Oslo, September 6th 2022 • The Ultimovacs team is inviting stakeholders, shareholders, collaboration partners, friends, and supporters for an informal after-work event • Short presentations by Ultimovacs team members, and opportunities for informal mingling with lig
Slide 23: Key Takeaways from the Q2 2022 Report
Key Takeaways from the Q2 2022 Report • INITIUM and NIPU on track to expected topline readout during H1 2023 with good patient enrollment • Positive survival data in the UV1-103 trial – 24-month overall survival rate of 73% across all 30 patients • Continue to present to the medical and scientific c
Slide 24: Q&A
Q&A
Slide 25: Enabling the Immune System to Fight Cancer For questions
Enabling the Immune System to Fight Cancer For questions Carlos de Sousa, CEO Anne Worsøe, Head of IR carlos.desousa@ultimovacs.com ir@ultimovacs.com +47 908 92507 +47 906 86815 www.ultimovacs.com