Zelluna Asa · OSL:ZLNA
Zelluna Asa — Ultimovacs — Q1 2023 Earnings Presentation
27 slides from Zelluna Asa's earnings presentation, May 10, 2023
Slide 1: First Quarter 2023 Results
First Quarter 2023 Results Ultimovacs ASA, 10 May 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: Ultimovacs is a clinical-stage biotech developing a universal, off-the-shelf cancer vaccine
Ultimovacs is a clinical-stage biotech developing a universal, off-the-shelf cancer vaccine in a broad clinical program Universal, off-the-shelf cancer vaccine, targeting telomerase • Telomerase is expressed in 85-90% of cancer types throughout all disease stages • Target essential for cancer cell s
Slide 4: Q1 2023 highlights: Prepared for multiple catalysts over the next months
Q1 2023 highlights: Prepared for multiple catalysts over the next months as the UV1 Phase II randomized clinical program advances • A rigorous data-driven strategy towards regulatory approval • Lead product, universal cancer vaccine UV1, is investigated in five randomized, comparative Phase II clini
Slide 5: Contents
Ultimovacs First Quarter 2023 presentation Contents 1. Operations 2. Financials 3. Newsflow 1Q 2023 Report, Non-Confidential 5
Slide 6: Broad Phase II program ongoing, will enroll more than 670 patients
Broad Phase II program ongoing, will enroll more than 670 patients Expected Indication Checkpoint inhibitor(s) Patients (#) Recruited topline Phase I Phase II Phase III IIT Contributors readout UV1-ipi Malignant Ipilimumab 12 Completed Completed melanoma UV1-103 Malignant Pembrolizumab 30 Completed
Slide 7: Clinical program: Update on patient enrollments
Clinical program: Update on patient enrollments, per 9 May 2023 Clinical trial program Enrollment and expected readout timeline INITIUM (Phase II malignant melanoma): Enrollment of 156 patients completed** Expected readout: H2 2023 NIPU (Phase II pleural mesothelioma): Enrollment of 118 patients com
Slide 8: 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 9: UV1 Phase II program: a data-driven strategy towards regulatory approval
UV1 Phase II program: a data-driven strategy towards regulatory approval mPFS (# of Months) • Broad comparative clinical program investigating 12 UV1 across various tumor types and diverse 100% 10 biology 90% • The objective is to understand if adding UV1 on 80% 8 top of checkpoint inhibitors: 70% •
Slide 10: UV1-103 study shows promising progression-free and overall survival rates
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) 1Q 2023 Report, Non-Confidential 10
Slide 11: 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 12: 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 n % Response (iRECIST) ORR (n=30) 17 56.7 Complete Response 10 33.3 Partial Response 7 23.3 Stable Disease 2 6.7 Progressiv
Slide 13: Updated timeline for readout from the UV1 Phase II INITIUM trial
Updated timeline for readout from the UV1 Phase II INITIUM trial in malignant melanoma • INITIUM is an Ultimovacs-sponsored randomized, Phase II trial, evaluating UV1 in combination with ipilimumab and nivolumab INITIUM • 156 patients with metastatic malignant melanoma were enrolled in the First lin
Slide 14: About Malignant Pleural Mesothelioma
About Malignant Pleural Mesothelioma • MPM is considered an aggressive cancer with high mortality rate and few therapeutic options • The cancer takes several decades to develop after patients often have been environmentally and occupationally exposed to asbestos • FDA approved nivolumab (Opdivo®) +
Slide 15: Readout still expected in Q2 2023 from the UV1 Phase II NIPU trial
Readout still expected in Q2 2023 from the UV1 Phase II NIPU trial in metastatic malignant pleural mesothelioma (MPM) • NIPU is a randomized, investigator-initiated Phase II NIPU clinical trial sponsored by Oslo University Hospital Second line metastatic malignant with support from Bristol-Myers Squ
Slide 16: Contents
Ultimovacs First Quarter 2023 presentation Contents 1. Operations 2. Financials 3. Newsflow 1Q 2023 Report, Non-Confidential 16
Slide 17: Q1 2023 Key Financials
Q1 2023 Key Financials Cash and liquidity • MNOK 406/MUSD 39 in cash by end of Q1 2023 • Expected financial runway until mid-2024 (no change in guiding) EBIT and PBT • EBIT Q1 2023 was MNOK -51 • Profit before tax Q1 2023 was MNOK -34 Operating expenses – development and variations • Payroll expense
Slide 18: Key financials
Key financials Comments: Key financials per Q1-2023 - Ultimovacs Group Payroll expenses NOK (000) Q1-22 Q1-23 FY22 ▪ Total payroll expenses were higher in Q1 2023 compared to same Total revenues - - - period the previous year; Payroll and payroll related expenses 11 384 21 002 71 466 ▪ Regular salar
Slide 19: Key financials – quarterly operating cash flow
Key financials – quarterly operating cash flow NOK (000) – Negative amounts Comments: • Negative operating cash-flow in Q1 2023 was appr. MNOK -37, significantly lower than EBIT of MNOK -51 due to changes in working capital • Continued quarterly variations should be expected, mainly driven by R&D ex
Slide 20: Key financials – quarterly overview
Key financials – quarterly overview Key financials per Q1-2023 - Ultimovacs Group NOK (000) Q1-22 Q2-22 Q3-22 Q4-22 Q1-23 Total revenues - - - - - Payroll and payroll related expenses 11 384 14 340 14 112 31 630 21 002 - Payroll expenses not incl. option costs and grants 13 406 9 100 13 979 14 392 1
Slide 21: Contents
Ultimovacs First Quarter 2023 presentation Contents 1. Operations 2. Financials 3. Newsflow 1Q 2023 Report, Non-Confidential 21
Slide 22: Expected milestones: Key value inflection points during the next years
Expected milestones: Key value inflection points during the next years UV1 2023 2024 2025 Malignant melanoma: Phase II, INITIUM Phase II: INITIUM H2: Topline results Phase I: UV1-103 Phase I, UV1–103 H1: 3-yr OS update Phase II, NIPU Malignant pleural H1: Enrollment completed mesothelioma: NIPU Phas
Slide 23: Increasingly favourable timing for cancer vaccine randomized Phase II readouts
Increasingly favourable timing for cancer vaccine randomized Phase II readouts in the evolving immune-oncology landscape 1Q 2023 Report, Non-Confidential 23
Slide 24: UV1 has a strong competitive profile: universal and easy-to-use
UV1 has a strong competitive profile: It is universal and easy-to-use, has low production costs and simple administration 1 Universal and easy to use 2 Low cost production 3 Simple logistics • UV1 is an off-the-shelf • Straight forward • Normal refrigeration product, i.e. can be manufacturing proces
Slide 25: Investor Day, Tuesday 20 June: Meet the team for afterwork in Bergen
Investor Day, Tuesday 20 June: Meet the team for afterwork in Bergen Sign up on our website or email IR@ultimovacs.com 1Q 2023 Report, Non-Confidential 25
Slide 26: Summary: Ultimovacs' first quarter 2023
Summary: Ultimovacs’ first quarter 2023 • Completed enrollment in UV1 Phase II trial NIPU in January 2023 • Patients in INITIUM trial are taking longer to experience disease progression compared to historical data, encouraging and very positive for the patients • Several key value inflection points
Slide 27: Q&A
Q&A ir@ultimovacs.com