Zelluna Asa · OSL:ZLNA
Zelluna Asa — Ultimovacs — Q4 2023 Earnings Presentation
28 slides from Zelluna Asa's earnings presentation, Feb 14, 2024
Slide 1: Enabling the Immune System to Fight Cancer – Fourth Quarter 2023 Results
Enabling the Immune System to Fight Cancer Fourth Quarter 2023 Results Ultimovacs ASA, February 14, 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 “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: Approaching a key inflection point for UV1
Approaching a key inflection point for UV1 • Near-term readout of UV1 Phase II study INITIUM in unresectable or metastatic malignant melanoma • Readout expected next month, in March 2024 • Meeting the primary endpoint will represent a major breakthrough • If the readout is positive, the results will
Slide 4: Q4 2023 highlights: Continued strong progress
Q4 2023 highlights: Continued strong progress • Clinically meaningful survival data reported at the ESMO Congress in UV1 Phase II study NIPU in malignant mesothelioma • Orphan Drug Designation and Fast Track Designation granted by the FDA • Demonstrated sustained long-term survival in Phase I study
Slide 5: A data-driven approach across cancer indications
A data-driven approach across cancer indications Cancer Checkpoint Patients Enrollment Expected indication inhibitors (#) status topline readout Phase I Phase II Sponsor UV1-ipi Malignant Ipilimumab 12 melanoma UV1-103 Malignant Pembrolizumab 30 melanoma INITIUM Malignant Ipilimumab melanoma Nivolum
Slide 6: Contents
Ultimovacs Fourth Quarter 2023 presentation Contents 1. Clinical update 2.Financial update 3.Newsflow Non-Confidential 6
Slide 7: Targeting telomerase - a “hallmark of cancer”
Targeting telomerase - a “hallmark of cancer” Hallmarks of Cancer1 Telomerase UV1 vaccine Characteristics Qualities Universal 85-90% of tumor Applicable to a broad types express range of cancer types telomerase2,3 Essential Tumor cells depend High relevance in on expressing heterogenous tumor telome
Slide 8: Phase I trial UV1-103: Sustained long-term overall survival
Phase I trial UV1-103: Sustained long-term overall survival UV1 + pembrolizumab in patients with unresectable or metastatic malignant melanoma Overall Survival (n=30)** • Median progression free survival (mPFS): 18.9 months • UV1 has demonstrated a good safety profile • Patients will continue to be
Slide 9: Extensive randomized Phase II clinical program
Extensive randomized Phase II clinical program Trial 1 NIPU 2 INITIUM 3 FOCUS 4 DOVACC 5 LUNGVAC Immunotherapy Ipilimumab + Ipilimumab + Pembrolizumab Durvalumab + Cemiplimab combination nivolumab nivolumab olaparib Indication Second line First line First line head Second line First line non- mesoth
Slide 10: NIPU: Second-line Malignant Mesothelioma
NIPU: Second-line Malignant Mesothelioma NIPU • Investigator-initiated trial led by Oslo University Hospital, Unresectable or Metastatic supported by Bristol Myers Squibb and Ultimovacs Malignant Mesothelioma • Enrolled 118 patients with inoperable malignant pleural UV1 Nivolumab mesothelioma from f
Slide 11: NIPU: Encouraging results presented at ESMO 2023
NIPU: Encouraging results presented at ESMO 2023 Objective Response Rate (per BICR) Overall survival 35 • UV1 plus ipi/nivo improved overall 30 survival (OS) vs ipi/nivo alone, 31% reducing the risk of death by 27% 25 20 • UV1 plus ipi/nivo demonstrated * improved Median OS vs ipi/nivo alone 15 with
Slide 12: Regulatory designations in mesothelioma granted to UV1
Regulatory designations in mesothelioma granted to UV1 • In October 2023, the FDA granted Orphan Drug Designation to UV1 for treatment of patients with mesothelioma • In February 2024, the FDA granted Fast Track Designation to UV1 in combination with ipilimumab and nivolumab for treatment of patient
Slide 13: No toxicity added to ipilimumab/nivolumab treatment
No toxicity added to ipilimumab/nivolumab treatment • The addition of UV1 to ipilimumab and nivolumab was safe with adverse events profile similar in both groups • In the NIPU trial, the percentage of patients with serious adverse events was similar in both arms Q4 2023 Report, Non-Confidential 13
Slide 14: Next steps for UV1 in mesothelioma
Next steps for UV1 in mesothelioma • Ultimovacs will: • Evaluate the current results from NIPU together with more detailed analyses as well as more updated data as it matures • Discuss with regulatory authorities and Key Opinion Leaders how these results should define the optimal way forward into a
Slide 15: INITIUM: First-line Advanced Malignant Melanoma
INITIUM: First-line Advanced Malignant Melanoma • Sponsored by Ultimovacs • Enrolled 156 patients from 40 sites in four countries: US, UK, INITIUM Belgium and Norway between June 2020 - July 2022 Unresectable or Metastatic Malignant Melanoma • It is taking longer than anticipated for the patients in
Slide 16: INITIUM in the first-line treatment landscape of advanced melanoma
INITIUM in the first-line treatment landscape of advanced melanoma Melanoma Stage IIB IIC IIIA IIIB IIIC IIID IV Operable Operable? Yes No Neoadjuvant PD-11 Does not tolerate Tolerates Surgery Surgery PD-1/CTLA-4 PD-1/CTLA-4 PD-1 PD-1 PD-1 Adjuvant Adjuvant LAG3 CTLA-4 PD-1 PD-1 UV1-103 INITIUM Curr
Slide 17: FOCUS: First-line Head and Neck Cancer
FOCUS: First-line Head and Neck Cancer • Investigator-initiated trial sponsored by Halle FOCUS University Hospital network, supported by Recurrent or metastatic head and Ultimovacs neck squamous cell carcinoma • Enrolled 75 patients from ten sites in Germany between August 2021 and August 2023 UV1 P
Slide 18: Phase II Trials enrolling: DOVACC and LUNGVAC
Phase II Trials enrolling: DOVACC and LUNGVAC DOVACC: High-grade BRCA negative ovarian LUNGVAC: 1L Advanced or metastatic non-small cancer, 2L maintenance cell lung cancer (NSCLC) • Combination: Olaparib, durvalumab • Combination: Cemiplimab • Contributors: NSGO/ENGOT (sponsor), AstraZeneca • Contri
Slide 19: The TET technology & TENDU trial
The TET technology & TENDU trial TET: A therapeutic vaccine concept for activating specific T cells that can target and eradicate cancer cells • Dose-escalation, first-in-human Phase I trial: TENDU Patients with relapse after primary • The TENDU trial investigates a prostate cancer specific radical
Slide 20: Contents
Ultimovacs Fourth Quarter 2023 presentation Contents 1. Clinical update 2. Financial update 3. Newsflow Non-Confidential 20
Slide 21: Q4 2023 Key Financials
Q4 2023 Key Financials Cash and liquidity • MNOK 267/MUSD 25 in cash by end of Q4 2023 • Expected financial runway through 2024 (updated guidance) EBIT and PBT • EBIT: Q4 2023 MNOK -60 and FY 2023 MNOK -216 • Profit before tax: Q4 2023 MNOK -56 and FY 2023 MNOK -189 Operating expenses – development
Slide 22: Key financials
Key financials Comments: Payroll expenses Key financials per Q4-2023 - Ultimovacs Group § Total payroll expenses were lower in Q4 2023 compared to Q4 NOK (000) Q4-22 Q4-23 FY22 FY23 2022, and higher in FY 2023 compared to FY2022: Total revenues - - - - § Regular salary costs were higher in Q4 2023 a
Slide 23: Key financials – quarterly operating cash flow
Key financials – quarterly operating cash flow NOK (000) – Negative amounts Comments: • Negative operating cash-flow in Q4 2023 was appr. MNOK -47, less than EBIT of -60 due to changes in working capital and the non-cash share option cost element • Continued quarterly variations should be expected,
Slide 24: Key financials – quarterly overview
Key financials – quarterly overview Key financials per Q4-2023 - Ultimovacs Group NOK (000) Q1-22 Q2-22 Q3-22 Q4-22 Q1-23 Q2-23 Q3-23 Q4-23 Total revenues - - - - - - - - Payroll and payroll related expenses 11 384 14 340 14 112 31 630 21 002 4 359 24 518 25 251 - Pa yrol l expens es not i ncl . opt
Slide 25: Contents
Ultimovacs Fourth Quarter 2023 presentation Contents 1. Clinical update 2. Financial update 3. Newsflow Non-Confidential 25
Slide 26: Newsflow & milestones: Key value inflection points
Newsflow & milestones: Key value inflection points UV1 VACCINE 2H 2023 2024 2025/2026 Phase II, INITIUM Malignant melanoma: Topline result Phase II: INITIUM March 2024 Phase I: UV1-103 Phase I, UV1–103 Phase I, UV1–103 Phase I, UV1–103 Phase I, UV1–103 Q4: 4-yr OS Cohort 1 Q2: 4-yr OS update total Q
Slide 27: Q4 2023 Summary
Q4 2023 Summary • Well prepared for the INITIUM readout in March 2024 • Meeting the primary endpoint will represent a major breakthrough • Positive results to be presented in a peer-review setting • NIPU data presented by the principal investigator at the ESMO Congress 2023 in Madrid • UV1 showed cl
Slide 28: Q&A
@& ultimo Det ir@ultimovacs.com