Zelluna Asa · OSL:ZLNA
Zelluna Asa — Ultimovacs — Q2 2023 Earnings Presentation
22 slides from Zelluna Asa's earnings presentation, Aug 22, 2023
Slide 1: Second Quarter 2023 Results
Second Quarter 2023 Results Ultimovacs ASA, 22 August 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: Broad Phase II program ongoing, will enroll more than 670 patients
Broad Phase II program ongoing, will enroll more than 670 patients Expected Investigator- Indication Checkpoint inhibitor(s) Patients (#) Enrolled topline Phase I Phase II Initiated Trial readout Contributors UV1-ipi Malignant Ipilimumab 12 Completed Completed melanoma UV1-103 Malignant Pembrolizuma
Slide 5: Q2 2023 highlights: Waiting for the data from three UV1 Phase II trials
Q2 2023 highlights: Waiting for the data from three UV1 Phase II trials • INITIUM: Unresectable or metastatic malignant melanoma (N=156) • Readout after 70 confirmed cases of disease progression or death, which has not yet occured • Topline results expected H1 2024. Assuming continued slow progressi
Slide 6: Q2 2023 highlights: Scientific acknowledgment and advancement
Q2 2023 highlights: Scientific acknowledgment and advancement • More than 300 cancer patients have received treatment with UV1; no safety concerns reported to date • Strong 3-year survival data reported from the UV1-103 study; all patients in cohort 2 who were alive after 2 years remained alive afte
Slide 7: Contents
Ultimovacs Second Quarter 2023 presentation Contents 1. Operations 2. Financials 3. Newsflow Q2 2023 Report, Non-Confidential 7
Slide 8: 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, biologies, and CPI combinations Trial design 1 INITIUM 2 NIPU1 3 FOCUS1 4 DOVACC1 5 LUNGVAC1 CPI combination Ipilimumab + Ipilimumab + Pembrolizumab Durvalumab + Cemiplimab nivolumab nivolumab ol
Slide 9: Clinical trials enrollment updates, per August 2023
Clinical trials enrollment updates, per 21 August 2023 Clinical trial program Enrollment and expected readout timeline INITIUM (Phase II malignant melanoma): Enrollment of 156 patients completed** Expected readout: H1 2024 NIPU (Phase II pleural mesothelioma): Enrollment of 118 patients completed Ex
Slide 10: INITIUM – unresectable or metastatic malignant melanoma
INITIUM – unresectable or metastatic malignant melanoma • Sponsored by Ultimovacs • Enrolled 156 patients from 39 sites in four countries: US, UK, Belgium and Norway UV1 nivolumab nivolumab • Recruitment: 100%. First patient Ipilimumab Ipilimumab enrolled June 2020, last patient enrolled in (N=78)
Slide 11: NIPU - Second line malignant metastatic pleural mesothelioma (MPM)
NIPU - Second line malignant metastatic pleural mesothelioma (MPM) • Investigator-initiated trial led by Oslo University Hospital, supported by Ultimovacs and Bristol Meyer Squibbs • Enrolled 118 patients from six sites in five countries: Australia, Spain, Denmark, Sweden and Norway UV1 • Recruitme
Slide 12: FOCUS - metastatic or recurrent head and neck squamous cell carcinoma
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 • Recruitment: 100%. First patient enrolled August pembrolizumab pembroliz
Slide 13: Contents
Ultimovacs First Quarter 2023 presentation Contents 1. Operations 2. Financials 3. Newsflow Q2 2023 Report, Non-Confidential 13
Slide 14: Q2 2023 Key Financials
Q2 2023 Key Financials Cash and liquidity • MNOK 344/MUSD 32 in cash by end of Q2 2023 • Expected financial runway to H2 2024 (changed from mid-2024), i.e., through the reporting of overall survival data in NIPU and the topline readouts in INITIUM and FOCUS EBIT and PBT • EBIT: Q2 2023 MNOK -51 and
Slide 15: Key financials
Key financials Comments: Key financials per Q2-2023 - Ultimovacs Group Payroll expenses NOK (000) Q2-22 Q2-23 YTD22 YTD23 FY22 ▪ Total payroll expenses were lower in Q2 2023 compared to same Total revenues - - - - - period the previous year, and at the same level YTD23 as YTD22; Payroll and payroll
Slide 16: Key financials – quarterly operating cash flow
Key financials – quarterly operating cash flow NOK (000) – Negative amounts Comments: • Negative operating cash-flow in Q2 2023 was appr. MNOK -70, significantly more than EBIT of -50 due to changes in working capital and the negative, non- cash share option cost element • Continued quarterly variat
Slide 17: Key financials – quarterly overview
Key financials – quarterly overview Key financials per Q2-2023 - Ultimovacs Group NOK (000) Q1-22 Q2-22 Q3-22 Q4-22 Q1-23 Q2-23 Total revenues - - - - - - Payroll and payroll related expenses 11 384 14 340 14 112 31 630 21 002 4 359 - Pa yrol l expens es not i ncl . option cos ts a nd gra nts 13 406
Slide 18: Contents
Ultimovacs First Quarter 2023 presentation Contents 1. Operations 2. Financials 3. Newsflow Q2 2023 Report, Non-Confidential 18
Slide 19: Newsflow & milestones: Key value inflection points during the next year
Newsflow & milestones: Key value inflection points during the next year UV1 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, UV1–103 Phase I, UV1–103 Q2: 3-yr OS update Q2:
Slide 20: Investor Day, Thu 24 August: Meet the team for afterwork in Trondheim
Investor Day, Thu 24 August: Meet the team for afterwork in Trondheim Sign up on our website or email IR@ultimovacs.com Q2 2023 Report, Non-Confidential 20
Slide 21: Summary: A transformational year ahead - waiting for data from three UV1 Phase II trials
Summary: A transformational year ahead - waiting for data from three UV1 Phase II trials in different cancer indications and biologies • Patients in INITIUM trial are taking longer to experience disease progression compared to historical data. 70 events are still outstanding, which is very positive
Slide 22: Q&A
Q&A ir@ultimovacs.com