Slide 1: Enabling the Immune System to Fight Cancer
Enabling the Immune System to Fight Cancer Second Quarter 2021 Presentation 20 August 2021 Carlos de Sousa, CEO Jens Bjørheim, CMO Hans Vassgård Eid, CFO
Slide 2: Important Notice and Disclaimer
Important Notice and Disclaimer This presentation may contain certain forward-looking statements and forecasts based on uncertainty, since they relate to events and depend on circumstances that will occur in the future and which, by their nature, will have an impact on Ultimovacs’ business, financia
Slide 3: Table of Contents
Table of Contents Highlights Q2 2021 Operational Update Q2 2021 Key financials Q2 2021 & Newsflow 3 Non-Confidential, Ultimovacs copy and distribution rights
Slide 4: Highlights Q2 2021
Highlights Q2 2021 Encouraging results from the Phase I clinical trial of UV1 combined with pembrolizumab in malignant melanoma • 30 patients split on two cohorts • Data from cohort 1 were presented in June at the ASCO 2021 Annual Meeting. • Results from cohort 2 were announced on 12 August 2021 • C
Slide 5: Highlights Q2 2021 (cont.)
Highlights Q2 2021 (cont.) The broad UV1 Phase II program is progressing well • INITIUM (154 patients): Ultimovacs sponsored trial in malignant melanoma in which UV1 is combined with nivolumab and ipilimumab. • 68 patients enrolled as of 19 August 2021 (compared to 40 patients in the previous quarte
Slide 6: Highlights Q2 2021 (cont.)
Highlights Q2 2021 (cont.) TENDU • Enrollment of the first cohort of three patients treated with the lowest dose is completed. In June 2021, having found no safety concerns in the first cohort, the Drug Safety Monitoring Board allowed the dose to be increased to 400 μg for the next patient in cohort
Slide 7: Table of Contents
Table of Contents Highlights Q2 2021 Operational Update Q2 2021 Key Financials Q2 2021 & Newsflow 7 Non-Confidential, Ultimovacs copy and distribution rights
Slide 8: Supports Broad Phase II UV1 Pipeline in >500 Patients
Supports Broad Phase II UV1 Pipeline in >500 Patients Pre- Indication Clinical trial information clinical Phase I Phase II Phase III Contributors First line metastatic With pembrolizumab malignant melanoma 30 patients INITIUM First line metastatic With ipilimumab & nivolumab malignant melanoma 154 p
Slide 9: Phase I UV1 + pembrolizumab in Malignant Melanoma - Encouraging Results with Good Safety
Phase I UV1 + pembrolizumab in Malignant Melanoma - Encouraging Results with Good Safety and Strong Signals of Efficacy Phase I Trial Design Key results announced during Q2 2021: Cohort 1 at 18 months (ASCO), Cohort 2 at 12 months • Good safety profile supporting use of UV1 in combination UV1 UV1 tr
Slide 10: Phase I UV1 + pembrolizumab in Malignant Melanoma - Strong Signals of Efficacy
Phase I UV1 + pembrolizumab in Malignant Melanoma - Strong Signals of Efficacy • The Response Rates for the 30 patients in cohort 1 and cohort 2 combined, as measured by iRECIST: - complete response (CR) 9/30 Objective response rate (ORR) 57%, - partial response (PR) 8*/30 Complete response rate (CR
Slide 11: Phase I UV1 + pembrolizumab - Strong Response Rates vs. Historical Data
Phase I UV1 + pembrolizumab in Malignant Melanoma - Strong Response Rates vs. Historical pembrolizumab Data Impact on Tumor Size Topline readout from Phase I trial1 in malignant melanoma compared to historical pembrolizumab data2 70% 57% 60% 50% 40% 33%-37%2 30% 30% 20% 5-12%2 10% 0% Objective Respo
Slide 12: Phase I UV1 + pembrolizumab - Encouraging OS & mPFS vs. Historical Data
Phase I UV1 + pembrolizumab in Malignant Melanoma - Encouraging OS & mPFS vs. Historical pembrolizumab Data Overall Survival at 12 months Median Progression Free Survival Topline readout from Phase I trial in malignant melanoma compared to historical pembrolizumab data1 100% 87% UV1 + pembrolizumab:
Slide 13: INITIUM and NIPU Ongoing Phase II Trials
INITIUM and NIPU Ongoing Phase II Trials INITIUM NIPU • Randomized Phase II trial in 1st line treatment of patients with • Randomized Phase II trial in 2nd line malignant pleural mesothelioma metastatic malignant melanoma • Sponsored by Oslo University Hospital in collaboration with BMS • Ultimovacs
Slide 14: DOVACC and FOCUS Phase II Trials initiating Patient Enrollment
DOVACC and FOCUS Phase II Trials initiating Patient Enrollment DOVACC FOCUS • Randomized Phase II second maintenance trial in BRCA negative • Randomized phase II trial in patients with recurrent or ovarian cancer patients metastatic PDL1 positive head and neck cancer • Sponsored by NSGO/ENGOT in col
Slide 15: The TENDU Phase I Trial
The TENDU Phase I Trial • This trial investigates a prostate cancer specific vaccine based on the TET technology Patients with relapse after Primary Radical Prostatectomy (N=9-12) TENDU • The TENDU trial is conducted at Oslo University Hospital • 9-12 patients will be enrolled 3 different doses • Th
Slide 16: Table of Contents
Table of Contents Highlights Q2 2021 Operational Update Q2 2021 Key Financials Q2 2021 & Newsflow 16 Non-Confidential, Ultimovacs copy and distribution rights
Slide 17: Key Financials
Key Financials Comments: Key financials per Q2-2021 - Ultimovacs Group NOK (000) Q2-20 0 Q2-21 0 YTD20 YTD21 FY20 Payroll expenses Total revenues - - 0 - - - ▪ Higher cost in YTD21/Q2-21 than same periods in 2020 Payroll and payroll related expenses 13 197 14 514 23 212 26 716 50 989 due to: Externa
Slide 18: Key Financials – Operating Cash Flow
Key Financials – Operating Cash Flow NOK (000) – Negative amounts Comments: • The negative operating cashflow in Q2-21 is around the same level as in previous quarters in 2020/21 • A further increase in the negative operating cashflow related to R&D should be expected in the second half of 2021 with
Slide 19: Key Financials – Quarterly Overview
Key Financials – Quarterly Overview Key financials per Q2-2021 - Ultimovacs Group NOK (000) Q1-20 Q2-20 Q3-20 Q4-20 Q1-21 Q2-21 Total revenues - - - - - - Payroll and payroll related expenses 10 015 13 197 13 115 14 662 12 203 14 514 External R&D and IPR expenses (incl. grants) 18 089 19 938 15 307
Slide 20: Expected News Flow and Milestones
Expected News Flow and Milestones 2021 2022 2023 Q1 Q2 Q3 Q4 Cohort 1, Cohort 2, Cohort 1 H2: Topline MALIGNANT results Phase II 21 m update, 1-yr update 2-yr update MELANOMA INITIUM Phase I US Phase I US Phase I US MALIGNANT H2: Topline PLEURAL results Phase II MESOTHELIOMA NIPU Topline results Ova
Slide 21: Key Takeaways From Q2 Report
Key Takeaways From Q2 Report • Encouraging results from the Phase I clinical trial of UV1 combined with pembrolizumab in malignant melanoma • The broad UV1 Phase II program is progressing well • 4 indications, different combinations • More than 500 patients at more than 90 hospitals in appr. 15 coun
Slide 22: Q&A
Q&A
Slide 23: Enabling the Immune System to Fight Cancer For questions
Enabling the Immune System to Fight Cancer For questions Carlos de Sousa, CEO Hans Vassgård Eid, CFO carlos.desousa@ultimovacs.com hans.eid@ultimovacs.com +47 908 92507 +47 482 48632 www.ultimovacs.com