Zelluna Asa · OSL:ZLNA
Zelluna Asa — Ultimovacs — Q1 2024 Earnings Presentation
30 slides from Zelluna Asa's earnings presentation, May 7, 2024
Slide 1: Empower the Immune System to Fight Cancer
Empower the Immune System to Fight Cancer First Quarter 2024 Business Update and Financial Results Ultimovacs ASA, May 7, 2024 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 expressed or implied by the forward-looking statements contained in this “Company”) for information purposes only and does not constitute an offer to presentation. Given these risks, uncertainties and other factors
Slide 3: Contents
Contents Introduction 01 Clinical update 02 Financial update 03 Newsflow 3
Slide 4: First quarter 2024 – Summary
INTRODUCTION First quarter 2024 – Summary • We remain confident in UV1’s potential and are committed to bringing Ultimovacs across the next important data points, FOCUS and DOVACC results • Positive Phase I data with UV1 • NIPU: UV1 demonstrated clinically relevant beneficial differences in risk of
Slide 5: UV1 regulatory designations in mesothelioma
UV1 regulatory designations in mesothelioma • EMA Orphan Drug Designation has been granted to UV1 for treatment of mesothelioma (February 2024) • FDA Fast Track Designation has been granted for UV1 as add-on therapy to ipilimumab and nivolumab for treatment of malignant pleural mesothelioma (Februar
Slide 6: Investigating UV1 across cancer indications and combinations
CLINICAL STRATEGY Investigating UV1 across cancer indications and combinations Phase II Phase I Indication Combination Randomized Contributors Single-arm trials controlled trials Malignant Ipilimumab INITIUM (N=156) melanoma Nivolumab Ultimovacs Malignant sponsored Pembrolizumab UV1-103 (N=30) melan
Slide 7: Clinical update
@ultimovacs 01 Clinical update
Slide 8: Phase II program: Capture Broad Potential and Right Development Path
Phase II program: Capture Broad Potential and Right Development Path • Positive Phase I data with UV1 • Robust and long-lasting immune responses after UV1 vaccination • Apparent synergy with checkpoint inhibitors (CPIs) • Strong efficacy signals and beneficial safety profile support development in P
Slide 9: Rationale behind different combination approaches
Rationale behind different combination approaches Anti-CTLA-4 and PD-1 Anti-PD-1/L1 INITIUM and NIPU trials FOCUS, DOVACC, and LUNGVAC trials • Most effective SoC immunotherapy in immunogenic • Widely established SoC in multiple indications (>35) solid tumors • Lack of anti-tumor T cell responses fi
Slide 10: Rationale behind different combination approaches
Rationale behind different combination approaches 1 Immune checkpoint blockade to improve: 1 T cell priming and expansion (anti-CTLA-4) 2 T cell effector function (anti-PD-1/L1) Mφ CD8 CD4 2 Confidential 10
Slide 11: A wide-ranging randomized controlled UV1 Phase II program
A wide-ranging randomized controlled UV1 Phase II program NIPU INITIUM FOCUS DOVACC LUNGVAC Second line First line malignant First line head and Second line ovarian First line non-small Indication mesothelioma melanoma neck cancer cancer cell lung cancer Immunotherapy Ipilimumab Ipilimumab Durvaluma
Slide 12: NIPU: Second-line malignant pleural mesothelioma
NIPU: Second-line malignant pleural mesothelioma Sponsor: Oslo University Hospital Contributors: BMS, Ultimovacs Sites and countries: Six hospitals in Norway, Sweden, Denmark, Spain and Australia NCT04300244 2L malignant metastatic pleural Primary endpoint: mesothelioma • Progression-free survival N
Slide 13: Encouraging response rate and survival outcomes
Encouraging response rate and survival outcomes No added toxicity compared to ipilimumab and nivolumab alone • Safety profile of UV1 plus ipilimumab and nivolumab is comparable to that of ipilimumab and nivolumab alone Primary endpoint progression-free survival not met according to BICR • Analysis o
Slide 14: INITIUM: First-line advanced melanoma
INITIUM: First-line advanced melanoma Sponsor: Ultimovacs Sites and countries: 39 hospitals in US, UK, Belgium and Norway NCT02275416 Primary endpoint: UV1 • Progression-free survival 1L unresectable 1L unresectable or or metastatic metastatic Ipilimumab • Blinded independent central review (BICR) m
Slide 15: Results from the INITIUM trial
Results from the INITIUM trial No added toxicity compared to ipilimumab and nivolumab alone • Safety profile of UV1 plus ipilimumab and nivolumab is comparable to that of ipilimumab and nivolumab alone Topline read-out • Ipilimumab and nivolumab demonstrated unprecedented and unexpected efficacy in
Slide 16: Next in line: UV1 in combination with single agent PD-1/L1
Next in line: UV1 in combination with single agent PD-1/L1 NIPU INITIUM FOCUS DOVACC LUNGVAC Second line First line malignant First line head and Second line ovarian First line non-small Indication mesothelioma melanoma neck cancer cancer cell lung cancer Immunotherapy Ipilimumab Ipilimumab Durvalum
Slide 17: FOCUS: First-line head and neck cancer
FOCUS: First-line head and neck cancer Sponsor: Halle University Hospital Network Contributors: Ultimovacs Sites and countries: 10 hospitals in Germany NCT05075122 Primary endpoint: UV1 • Progression-free survival rate at 6 1L head and neck cancer Pembrolizumab months (N=50) Secondary endpoints: N=7
Slide 18: FOCUS: Background
FOCUS: Background • Head and neck squamous cell carcinoma (HNSCC) refers to a group of malignancies arising from the linings of the head and neck region (oral cavity, pharynx, lip, sinuses, and salivary glands) • HNSCC is the 7th most common cancer globally (appx. 890.000 new cases in 2020) • Telome
Slide 19: DOVACC: Relapsed ovarian cancer
DOVACC: Relapsed ovarian cancer Sponsor: NSGO/ENGOT Contributors: AstraZeneca, Ultimovacs Sites and countries: 35 hospitals, 10 countries in Europe NCT04742075 High-grade BRCA negative ovarian UV1 cancer, 2L maintenance Olaparib Durvalumab Primary endpoint: N=184 (N=92) • Progression-free survival •
Slide 20: DOVACC: Background
DOVACC: Background • Ovarian cancer is a malignancy arising from surface epithelium in the ovaries. It is the second most common gynecologic malignancy and is the leading cause of death from gynaecological cancer. • Ovarian cancer is the 18th most common cancer overall • Standard treatment for advan
Slide 21: LUNGVAC: First-line non-small cell lung cancer
LUNGVAC: First-line non-small cell lung cancer Sponsor: Drammen Hospital Contributors: Ultimovacs Sites and countries: 9 hospitals in Norway NCT05344209 1L advanced or metastatic non-small cell UV1 Primary endpoint: lung cancer Cemiplimab Progression-free survival N=138 (N=69) • NSCLC stage IIIB/III
Slide 22: Financial update
@ultimovacs O02 Financial update
Slide 23: Q1 2024 Key Financials
Q1 2024 Key Financials Cash and liquidity • MNOK 220/MUSD 20 in cash by end of Q1 2024 • Activity level prioritization and operational adjustments are implemented to sustain the financial runway, including a workforce reduction of approximately 40%. • The cash preservation initiatives extend the ant
Slide 24: P&L and Cash
P&L and Cash Comments Key financials per Q1-2024 - Ultimovacs Group Payroll expenses NOK (000) Q1-23 Q1-24 FY23 Total revenues - - - • Due to a significant one-off item, total payroll expenses were lower in Q1 2024 compared to Q1 2023 (a negative cost of MNOK 2.4 in Q1 2024 vs MNOK 21 in Q1 2023): P
Slide 25: Quarterly operating cash flow
Quarterly operating cash flow Comments NOK (000) – Negative amounts • Negative operating cash-flow in Q1 2024 was appr. MNOK -46, higher than EBIT of MNOK -29, primarily due to the reversal of the social security tax approval related to share options of MNOK 21. • Continued quarterly variations shou
Slide 26: Quarterly overview P&L and Cash
Quarterly overview P&L and Cash Key financials per Q1-2024 - Ultimovacs Group NOK (000) Q1-23 Q2-23 Q3-23 Q4-23 Q1-24 Total revenues - - - - - Payroll and payroll related expenses 21 002 4 359 24 518 25 251 -2 425 - Pa yrol l expens es not i ncl . option cos ts a nd gra nts 14 652 10 808 14 751 16 1
Slide 27: Newsflow
@ultimovacs 03 Newsflow
Slide 28: Newsflow and milestones
INTRODUCTION Newsflow and milestones UV1 VACCINE 2H 2023 2024 2025 / 2026 Malignant melanoma Q4: 4-yr OS Cohort 1 Q2: 4-yr OS Total Phase I: UV1-103 Topline result Phase II: INITIUM March 2024 Malignant pleural Data presented at mesothelioma ESMO, Oct 21, 2023 Phase II: NIPU Head and neck cancer Exp
Slide 29: Ultimovacs is Committed to Bringing UV1 Across the Next Major Value Inflection Points
Ultimovacs is Committed to Bringing UV1 Across the Next Major Value Inflection Points • We remain confident in UV1’s potential and are committed to bringing Ultimovacs across the next important data points, FOCUS and DOVACC results • The investigators in the ongoing trials are also committed to brin
Slide 30: Q&A
@ultimovacs O&A