Zelluna Asa · OSL:ZLNA
Zelluna Asa — Ultimovacs — Q4 2022 Earnings Presentation
25 slides from Zelluna Asa's earnings presentation, Feb 16, 2023
Slide 1: Fourth Quarter 2022 Results
Fourth Quarter 2022 Results Ultimovacs ASA, 16 February 2023 Carlos de Sousa, CEO Jens Bjørheim, CMO Hans Vassgård Eid, CFO
Slide 2: Disclaimer
Disclaimer This presentation has been prepared by Ultimovacs ASA (“Ultimovacs” or the “Company”) for information purposes only and does not constitute an offer to sell common shares of the Company or a recommendation in relation to the shares of the Company. Neither shall the presentation or any par
Slide 3: Q4 2022 highlights: On track and prepared for readouts during H1 2023
Q4 2022 highlights: On track and prepared for readouts during H1 2023 for first Phase II studies with the universal cancer vaccine, UV1 • Ultimovacs is on track and prepared for key value inflection points during the first half of 2023 • Topline readouts from the first two UV1 Phase II clinical tria
Slide 4: Contents
Ultimovacs Fourth Quarter 2022 presentation Contents 1. Highlights 2. Operations 3. Financials 4. Newsflow 5. Q&A 4Q 2022 Report, Non-Confidential 4
Slide 5: Broad Phase II program ongoing with enrollment of more than 650 patients
Broad Phase II program ongoing with enrollment of more than 650 patients Expected Indication Checkpoint inhibitor(s) Patients (#) Recruited topline Phase I Phase II Phase III Contributors readout UV1-ipi Malignant Ipilimumab 12 Completed Completed melanoma UV1-103 Malignant Pembrolizumab 30 Complete
Slide 6: Patient enrollment and expected readouts
Patient enrollment and expected readouts Clinical trial program Enrollment and expected readout timeline INITIUM (Phase II malignant melanoma): Enrollment of 156 patients completed** Expected readout: H1 2023 NIPU (Phase II pleural mesothelioma): Enrollment of 118 patients completed Expected readout
Slide 7: UV1 induces T cell responses against telomerase: a hallmark of cancer
UV1 induces T cell responses against telomerase: a hallmark of cancer Hallmarks of Cancer1 Telomerase UV1 Vaccine Characteristics Qualities Universal 85-90% of tumor types Applicable to a broad express telomerase2,3 range of cancer types Essential Tumor cells depend on High relevance in expressing t
Slide 8: UV1-103 study shows promising progression-free and overall survival rates in malignant melanoma
The data from the UV1-103 study (U.S.) shows promising progression-free and overall survival rates in malignant melanoma Progression-free Survival (n=30) Overall Survival (n=30) 4Q 2022 Report, Non-Confidential 8
Slide 9: Deep and durable clinical responses to UV1 + pembrolizumab
Deep and durable clinical responses to UV1 + pembrolizumab Responses lasting up to 2 years (maximum follow-up) • Patients were followed with CT scans for up to two years • 57% of patients achieved an objective response to the treatment (>30% reduction in tumor size) • 33% of patients achieved comple
Slide 10: Robust clinical responses in patients typically obtaining reduced CPI efficacy
Robust clinical responses in patients typically obtaining reduced CPI efficacy Sustained high ORR and CR rate to UV1 + pembrolizumab combo in PD-L1 negative tumors Best Overall Response n % (iRECIST) ORR (n=30) 17 56.7 Complete Response 10 33.3 Partial Response 7 23.3 Stable Disease 2 6.7 Progressiv
Slide 11: Near-term key inflection points: Topline readouts from INITIUM and NIPU
Near-term key inflection points: Topline readouts from the first two UV1 Phase II trials, INITIUM and NIPU, expected in H1 2023 INITIUM NIPU First line advanced or metastatic Second line metastatic pleural malignant melanoma mesothelioma UV1 UV1 nivolumab nivolumab nivolumab nivolumab Ipilimumab ipi
Slide 12: Endpoints in randomized clinical trials
Endpoints in randomized clinical trials • The gold standard endpoint in oncology is overall survival • Progression-free survival (PFS) is an endpoint widely used as a surrogate for overall survival (OS) in Phase II • An endpoint in a clinical trial is an event or outcome that can be measured objecti
Slide 13: The cleaning of data before final topline results is a lengthy process
The cleaning of data before final topline results are available is a lengthy process • Cleaning activities are primarily done after the pre-defined number of endpoints are reached • Survival status will be checked on all patients • Independent read of all unread CT scans • All data will need to be e
Slide 14: The TENDU Phase I trial: First clinical evaluation of a TET vaccine adjuvant
The TENDU Phase I trial: First clinical evaluation of a TET vaccine adjuvant • The TENDU trial investigates a prostate cancer specific vaccine based on the TET technology • The trial is expected to provide valuable information on dose, safety and immune activation important for the further developme
Slide 15: Contents
Ultimovacs Fourth Quarter 2022 presentation Contents 1. Highlights 2. Operations 3. Financials 4. Newsflow 5. Q&A 4Q 2022 Report, Non-Confidential 15
Slide 16: Q4 2022 Key Financials
Q4 2022 Key Financials • Increase in operating expenses as expected • FY 2022 (MNOK 184) vs. FY 2021 (MNOK 164): +12% • Generally increased activity level, but increase in R&D costs have been lower than previously indicated (with some delayed milestones, partly due to longer start-up time in clinica
Slide 17: Key financials
Key financials Comments: Payroll expenses Key financials per Q4-2022 - Ultimovacs Group NOK (000) Q4-21 Q4-22 FY21 FY22 ▪ Total payroll expenses were higher in Q4-22 and FY22 compared to the previous year; Total revenues - - - - Payroll and payroll related expenses 11 885 31 630 61 916 71 466 ▪ Q4-2
Slide 18: Key financials – quarterly operating cash flow
Key financials – quarterly operating cash flow NOK (000) – Negative amounts Comments: • Operating cash flow has increased mainly because of increased activity level within R&D (incl. execution of the broad Phase II program) • Quarterly variations should be expected, mainly driven by R&D expenses tha
Slide 19: Key financials – quarterly overview
Key financials – quarterly overview Key financials per Q4-2022 - Ultimovacs Group NOK (000) Q1-21 Q2-21 Q3-21 Q4-21 Q1-22 Q2-22 Q3-22 Q4-22 Total revenues - - - - - - - - Payroll and payroll related expenses 12 203 14 514 23 314 11 885 11 384 14 340 14 112 31 630 External R&D and IPR expenses (incl.
Slide 20: Contents
Ultimovacs Fourth Quarter 2022 presentation Contents 1. Highlights 2. Operations 3. Financials 4. Newsflow 5. Q&A 4Q 2022 Report, Non-Confidential 20
Slide 21: Cancer vaccines are on the agenda this year
Cancer vaccines are on the agenda this year 4Q 2022 Report, Non-Confidential 21
Slide 22: Where to meet us: Events & Conferences
Where to meet us: Events & Conferences An overview of some of the events and conferences where Ultimovacs will participate during H1 2023*: Events & Conferences When Where JPM Week January 8-12 San Francisco Redeye Fight Cancer January 19 Stockholm IO 360 Conference February 7-10 NYC SACHS CEO forum
Slide 23: Expected news flow and milestones: key value inflection points
Expected news flow and milestones: key value inflection points during the next 6-30 months UV1 2022 2023 2024 2025 Malignant melanoma: Phase II, INITIUM Phase II, INITIUM Phase II: INITIUM H1: Enrollment H1: Topline results completed Phase I: UV1-103 Phase I, UV1–103 Phase I, UV1–103 H1: 2-yr OS upd
Slide 24: Summary
Summary • Completed enrollment in INITIUM, NIPU and TENDU (Phase I) • On track to expected topline readout during H1 2023 in the UV1 Phase II trials INITIUM and NIPU • UV1 well positioned in the emerging cancer vaccine landscape • Universal (target, patients, and at all stages of cancer) • Off-the-s
Slide 25: Q&A
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