Zelluna Asa · OSL:ZLNA
Zelluna Asa — Ultimovacs — Q3 2022 Earnings Presentation
23 slides from Zelluna Asa's earnings presentation, Nov 10, 2022
Slide 1: Third Quarter 2022 Results
Third Quarter 2022 Results Ultimovacs ASA, 10 November 2022 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 2022 highlights: Continued strong progress towards key milestones
Q3 2022 highlights: Continued strong progress towards key milestones • Ultimovacs near key value inflection points • Readouts from the first two UV1 phase II clinical trials, INITIUM and NIPU, expected during the first half of 2023 • Overall, good patient enrollment continues in Ultimovacs’ clinical
Slide 4: Contents
Ultimovacs Third Quarter 2022 presentation Contents 1. Highlights 2. Operational update 3. Key financial update 4. Newsflow & summary 5. Q&A 3Q 2022 Report, Non-Confidential 4
Slide 5: A broad phase II clinical program enrolling more than 650 patients
A broad phase II clinical program enrolling more than 650 patients Expected Indication Clinical trial information topline Phase I Phase II Phase III Contributors readout UV1-ipi With ipilimumab Malignant melanoma Completed 12 patients UV1-103 With pembrolizumab Malignant melanoma Completed 30 patien
Slide 6: Patient enrollment in clinical trials per Q3 2022 reporting date
Patient enrollment in clinical trials per Q3 2022 reporting date Clinical trial: Enrollment per Q3 reporting date: INITIUM (ph II malignant melanoma): Recruitment of 156 patients completed in July 2022*. NIPU (ph II mesothelioma): 108 out of 118 patients enrolled (vs. 92 in the Q2 2022 report) FOCUS
Slide 7: Near-term key inflection points: Readouts from the first two UV1 phase II trials
Near-term key inflection points: Readouts from the first two UV1 phase II trials, INITIUM and NIPU, expected in H1 2023 INITIUM NIPU First line advanced or metastatic Second line malignant pleural mesothelioma malignant melanoma UV1 UV1 nivolumab nivolumab nivolumab nivolumab ipilimumab ipilimumab i
Slide 8: New data from UV1-103 study in malignant melanoma: Three-year overall survival of 71%
New data reported from UV1-103 study in malignant melanoma: Three-year overall survival of 71% in cohort one • The Response Rates for the 30 patients in cohort 1 and cohort 2 combined, as measured by iRECIST: Impact on Tumor Size Topline readout from Phase I trial in malignant • Complete response (C
Slide 9: Biomarker data from the UV1-103 study presented at the International Congress of the Society for Melanoma Research
Biomarker data from the UV1-103 study presented at the International Congress of the Society for Melanoma Research by MD Yousef Zacharia 3Q 2022 Report, Non-Confidential 9
Slide 10: The data shows promising progression-free and overall survival rates in the UV1-103 study
The data shows promising progression-free and overall survival rates in the UV1-103 study Progression-free Survival (n=30) Overall Survival (n=30) Best Overall Response n % (iRECIST) Objective Response Rate 17 56.7 • Complete Response 10 33.3 • Partial Response 7 23.3 Stable Disease 2 6.7 Confirmed/
Slide 11: UV1-103 biomarker data signals clinical responses are not impacted by PD-L1 level
UV1-103 biomarker data signals that clinical responses are not impacted by PD-L1 level when combining pembrolizumab with UV1 Each line corresponds to a patient Potential to expand target patient population * Each bar corresponds to a patient * Lymph node target lesion was reduced from 17.2 mm to 6.3
Slide 12: UV1-103 results indicate encouraging OS & mPFS vs. historical pembrolizumab data
UV1-103 results indicate encouraging OS & mPFS vs. historical pembrolizumab data in malignant melanoma Overall Survival at 12 and 24 months – All 30 patients Median Progression Free Survival Topline readout from Phase I trial in malignant melanoma compared to historical pembrolizumab data1 100% UV1
Slide 13: The phase I TENDU study will provide information towards further development of new vaccine solutions
The phase I TENDU study will provide information towards further development of new vaccine solutions based on the TET adjuvant technology platform Platform technology Vaccine design • Expected benefits: Improved safety profile, simplified • Core element is the vaccine adjuvant, a tetanus toxin admi
Slide 14: Contents
Ultimovacs Third Quarter 2022 presentation Contents 1. Highlights 2. Operational update 3. Key financial update 4. Newsflow & summary 5. Q&A 3Q 2022 Report, Non-Confidential 14
Slide 15: Key financials
Key financials Comments: Payroll expenses Key financials per Q3-2022 - Ultimovacs Group NOK (000) Q3-21 Q3-22 YTD21 YTD22 FY21 ▪ Total payroll expenses in Q3-22 and YTD22 were lower than previous year; Total revenues - - - - - Payroll and payroll related expenses 23 314 14 112 50 031 39 836 61 916 ▪
Slide 16: Key financials – quarterly operating cash flow
Key financials – quarterly operating cash flow NOK (000) – Negative amounts Comments: • Operating cash flow is expected to increase from the current level, mainly due to expected higher R&D costs • Quarterly variations should be expected, mainly driven by R&D expenses that will be influenced by seve
Slide 17: Key financials – quarterly overview
Key financials – quarterly overview Key financials per Q3-2022 - Ultimovacs Group NOK (000) Q1-21 Q2-21 Q3-21 Q4-21 Q1-22 Q2-22 Q3-22 Total revenues - - - - - - - Payroll and payroll related expenses 12 203 14 514 23 314 11 885 11 384 14 340 14 112 External R&D and IPR expenses (incl. grants) 16 012
Slide 18: Contents
Ultimovacs Third Quarter 2022 presentation Contents 1. Highlights 2. Operational update 3. Key financial update 4. Newsflow & summary 5. Q&A 3Q 2022 Report, Non-Confidential 18
Slide 19: Immuno-oncology industry highlights
Immuno-oncology industry highlights: • Increased focus on neoadjuvant treatment across cancer indications at ESMO 2022 • NICHE-2 (colon and rectal cancer) • SWOG S1801 (melanoma) • Cancer vaccines gained strong momentum in October • Merck + Moderna deal • BioNTech expectations 3Q 2022 Report, Non-Co
Slide 20: Expected news flow and milestones: Key value inflection points during the next 9-24 months
Expected news flow and milestones: Key value inflection points during the next 9-24 months UV1 2022 2023 2024 Phase I, UV1–103 Phase I, UV1–103 Malignant melanoma Q3: 2-yr OS update Q4: Cohort 1, (all 30 patients) 3-yr OS update Phase II, INITIUM Phase II, INITIUM Q2: Enrollment H1: Topline results
Slide 21: Summary
Summary • The first two UV1 phase II trials, INITIUM and NIPU, on track to expected topline readout during H1 2023 • Overall good patient enrollment continues in Ultimovacs’ clinical program • Positive survival data in the UV1-103 trial: 36-month overall survival rate of 71% in cohort one • Biomarke
Slide 22: Contents
Ultimovacs Third Quarter 2022 presentation Contents 1. Highlights 2. Operational update 3. Key financial update 4. Newsflow & summary 5. Q&A 3Q 2022 Report, Non-Confidential 22
Slide 23: Enabling the immune system to fight cancer
Enabling the immune system to fight cancer ir@ultimovacs.com