Zelluna Asa · OSL:ZLNA
Zelluna Asa — Ultimovacs — Q3 2023 Earnings Presentation
29 slides from Zelluna Asa's earnings presentation, Nov 8, 2023
Slide 1: Enabling the Immune System to Fight Cancer – Third Quarter 2023 Results
Enabling the Immune System to Fight Cancer Third Quarter 2023 Results Ultimovacs ASA, November 8, 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: Q3 2023: Achieving a remarkable milestone for the UV1 cancer vaccine
Q3 2023: Achieving a remarkable milestone for the UV1 cancer vaccine • Promising results from the first randomized UV1 Phase II trial, NIPU in malignant mesothelioma Data showed an encouraging and clinically meaningful improvement in overall survival when adding UV1 vaccination on top of ipilimumab
Slide 4: Phase II program ongoing across five cancer indications investigating UV1 vaccination
Phase II program ongoing across five cancer indications investigating UV1 vaccination in combination with various checkpoint inhibitors (CPIs) Cancer Checkpoint Patients Enrollment Expected Investigator-initiated indication inhibitors (#) status topline readout Phase I Phase II trial contributors NI
Slide 5: Contents
Ultimovacs Third Quarter 2023 presentation Contents 1. Clinical update 2. Financial update 3. Newsflow Non-Confidential 5
Slide 6: UV1 induces T cell responses against telomerase, a hallmark of cancer
UV1 induces T cell responses against telomerase a “hallmark of cancer” present in 85-90% of the different tumor types 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 Tumo
Slide 7: UV1 clinical program consists of five comparative, randomized Phase II trials
UV1 clinical program consists of five comparative, randomized Phase II trials in different cancer types and CPI combinations Trial design 1 NIPU 2 INITIUM 3 FOCUS 4 DOVACC 5 LUNGVAC CPI combination Ipilimumab + Ipilimumab + Pembrolizumab Durvalumab + Cemiplimab nivolumab nivolumab olaparib Indicatio
Slide 8: NIPU - Second line malignant pleural mesothelioma (MPM)
1 NIPU NIPU - Second line malignant pleural mesothelioma (MPM) • Investigator-initiated trial led by Oslo University Hospital, supported by Ultimovacs and Bristol Meyer Squibbs • Enrolled 118 patients with inoperable malignant pleural mesothelioma from six sites in Australia, Spain, Denmark, Sweden
Slide 9: MPM is one of the most challenging cancers to treat
1 NIPU MPM is one of the most challenging cancers to treat • Most patients: • Are diagnosed with advanced disease Current Treatment Options • Have poor prognosis and few therapeutic MPM options • Don’t have surgery as an option Chemotherapy Ipilimumab / First-line nivolumab mOS ≈ 14 mo2 mOS ≈ 18 mo2
Slide 10: The NIPU baseline demographics is relatively balanced
1 NIPU The NIPU baseline demographics is relatively balanced UV1 vaccine UV1 plus IPI-NIVO IPI-NIVO Total (N=118) (n=59) (n=59) Sex – n (%) Female 14 (23.7) 12 (20.3) 26 (22.0) Male 45 (76.3) 47 (79.7) 92 (78.0) Age Median 71 72 71 Range 39-79 42-83 39-83 ECOG – n (%) 0 17 (28.8) 18 (30.5) 35 (29.7)
Slide 11: UV1 Maintains an Excellent Safety Profile in the NIPU study
1 NIPU UV1 Maintains an Excellent Safety Profile in the NIPU study The addition of UV1 to IPI-NIVO was safe and did not noticeably increase occurrences of serious adverse events • In the NIPU trial, the percentage of patients with serious adverse events was similar in both arms • UV1 plus IPI-NIVO:
Slide 12: Near doubling of ORR and clinically meaningful prolonged survival
1 NIPU Near doubling of ORR and clinically meaningful prolonged survival Objective Response Rates (per BICR) Overall Survival* Ratio 35 30 25 20 Median 15 Observation Time: 10 17.3 months 5 0 ORR (%) UV1 plus IPI-NIVO IPI-NIVO Number at risk: Number of patients confirmed alive at each given timepoin
Slide 13: Progression-free survival (PFS) reported by BICR and Investigator Assessment
1 NIPU Progression-free survival (PFS) reported by BICR and Investigator Assessment Blinded Independent Central Review (BICR) Investigator Assessment * * Progression-free survival based on BICR† Progression-free survival based on Investigator Assessment HR = 1.01 (80% CI 0.75-1.36, 1-sided p value =
Slide 14: Assessing next steps for UV1 in mesothelioma
1 NIPU Assessing next steps for UV1 in mesothelioma • Ultimovacs management agrees with the trial investigators’ recommendation to advance UV1 to the next phase of development • Ultimovacs will • carefully evaluate the current results from NIPU together with more detailed analyses as well as more up
Slide 15: INITIUM – unresectable or metastatic malignant melanoma
2 INITIUM INITIUM – unresectable or metastatic malignant melanoma • Sponsored by Ultimovacs • Enrolled 156 patients from 39 sites in four countries: US, UK, UV1 Belgium and Norway. nivolumab nivolumab Ipilimumab Ipilimumab • First patient enrolled June 2020, last patient enrolled in (N=78) (N=78) Ju
Slide 16: INITIUM - updated timeline for topline readout
2 INITIUM INITIUM - updated timeline for topline readout • Since it is taking longer than anticipated for the patients in the INITIUM study to experience cancer progression, the study protocol for INITIUM has been amended to enable data analysis to start in mid-January 2024, after • the last enrolle
Slide 17: FOCUS - metastatic or recurrent head and neck squamous cell carcinoma
3 FOCUS FOCUS - metastatic or recurrent head and neck squamous cell carcinoma • Investigator-initiated trial sponsored by Halle University Hospital network, supported by Ultimovacs • Enrolled 75 patients from ten sites in Germany UV1 • First patient enrolled August 2021, last patient pembrolizumab p
Slide 18: DOVACC and LUNGVAC UV1 Phase II Trials
4 5 DOVACC & LUNGVACC DOVACC and LUNGVAC UV1 Phase II Trials DOVACC: High-grade BRCA negative ovarian LUNGVAC: Advanced or metastatic non-small cancer, second line maintenance cell lung cancer (NSCLC) • Combination: olaparib, durvalumab • Combination: cemiplimab • Contributors: NSGO/ENGOT (sponsor),
Slide 19: Sustained long-term overall survival in Phase I trial UV1-103
Sustained long-term overall survival in Phase I trial UV1-103 in malignant melanoma patients treated with pembrolizumab and UV1 vaccination Overall survival (OS) Overall Survival (n=30)** • Cohort 1+2 combined after 12 months: 86.7% • Cohort 1+2 combined after 24 months: 73.3% • Cohort 1+2 combined
Slide 20: The TENDU phase 1 trial: First clinical evaluation of the TET technology
The TENDU phase 1 trial: First clinical evaluation of the TET technology • The TENDU trial investigates a prostate cancer specific vaccine that is based on the TET technology • The trial is expected to provide valuable information on dose, safety and immune activation towards the further development
Slide 21: Contents
Ultimovacs First Quarter 2023 presentation Contents 1. Clinical update 2. Financial update 3. Newsflow Non-Confidential 21
Slide 22: Q3 2023 Key Financials
Q3 2023 Key Financials Cash and liquidity • MNOK 300/MUSD 27 in cash by end of Q3 2023 • Expected financial runway to H2 2024, through the topline readouts in INITIUM and FOCUS EBIT and PBT • EBIT: Q3 2023 MNOK -55 and YTD 2023 MNOK -156 • Profit before tax: Q3 2023 MNOK -56 and YTD 2023 MNOK -133 O
Slide 23: Key financials
Key financials Comments: Key financials per Q3-2023 - Ultimovacs Group Payroll expenses NOK (000) Q3-22 Q3-23 YTD22 YTD23 FY22 § Total payroll expenses were higher in Q3 2023 and YTD23 compared Total revenues - - - - - to same periods the previous year: Payroll and payroll related expenses 14 112 24
Slide 24: Key financials – quarterly operating cash flow
Key financials – quarterly operating cash flow NOK (000) – Negative amounts Comments: • Negative operating cash-flow in Q3 2023 was appr. MNOK -47, less than EBIT of -55 due to changes in working capital and the non-cash share option cost element • Continued quarterly variations should be expected,
Slide 25: Key financials – quarterly overview
Key financials – quarterly overview Key financials per Q3-2023 - Ultimovacs Group NOK (000) Q1-22 Q2-22 Q3-22 Q4-22 Q1-23 Q2-23 Q3-23 Total revenues - - - - - - - Payroll and payroll related expenses 11 384 14 340 14 112 31 630 21 002 4 359 24 518 - Pa yrol l expens es not i ncl . option cos ts a nd
Slide 26: Contents
Ultimovacs First Quarter 2023 presentation Contents 1. Clinical update 2. Financial update 3. Newsflow Non-Confidential 26
Slide 27: Newsflow & milestones: Key value inflection points during the next year
Newsflow & milestones: Key value inflection points during the next year and within current financial runway UV1 VACCINE 2023 2024 2025 Phase II, INITIUM Malignant melanoma: Exp. topline results Phase II: INITIUM H1 2024 Phase I: UV1-103 Phase I, UV1–103 Phase I, UV1–103 Phase I, UV1–103 Phase I, UV1
Slide 28: Key take-aways and next steps
Key take-aways and next steps • Encouraging data from NIPU, first randomized Phase II trial in the broad UV1 clinical program • Malignant mesothelioma is a hard-to-treat cancer, with UV1 results exceeding expectations • Discussing with regulatory authorities and Key Opinion Leaders regarding the pat
Slide 29: Q&A
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