Slide 1: Enabling the Immune System to Fight Cancer
Enabling the Immune System to Fight Cancer First Quarter 2022 Presentation 12 May 2022 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 Q1 2022 Operational Update Q1 2022 Key financials Q1 2022 & Newsflow 3 Non-Confidential, Ultimovacs copy and distribution rights
Slide 4: Highlights Q1 2022 – continued strong progress towards key milestones
Highlights Q1 2022 – continued strong progress towards key milestones • INITIUM and NIPU on track to expected topline readout during H1 2023 with good patient enrollment • Extended patent protection in the US for UV1 when used as combination treatment • Complete disappearance of tumors observed in y
Slide 5: Highlights Q1 2022: Progress in UV1 Phase II Program is Encouraging
Highlights Q1 2022: Progress in UV1 Phase II Program is Encouraging Continued good progress in the broad UV1 Phase II program • INITIUM: 137 out of 154 patients enrolled, compared to 120 patients in the Q4 2022 report • NIPU: 78 out of 118 patients enrolled, compared to 66 patients in the Q4 2022 re
Slide 6: Highlights Q1 2022: Extended patent protection for UV1
Highlights Q1 2022: Extended patent protection for UV1 Extended patent protection for UV1 when used as combination treatment • Notice of Allowance received from USPTO on a patent application for the use of vaccine-checkpoint inhibitor combinations to treat cancer • This will cover cancer treatments
Slide 7: Table of Contents
Table of Contents Highlights Q1 2022 Operational Update Q1 2022 Key Financials Q1 2022 & Newsflow 7 Non-Confidential, Ultimovacs copy and distribution rights
Slide 8: Phase I trials – mOS reached at 66.3 months in the UV1 + ipilimumab trial
Phase I trials – mOS reached at 66.3 months in the UV1 + ipilimumab trial Median overall survival reached at 66.3 months for the Phase I study in malignant melanoma where UV1 is combined with ipilimumab Completed Phase I trials in follow-up Overall Survival (OS)¹ Median OS mPFS² Clinical trial⁴ Year
Slide 9: Phase I UV1 + ipilimumab in Malignant Melanoma
Phase I UV1 + ipilimumab in Malignant Melanoma Good safety profile and signals of clinical efficacy Median Overall Survival Median Progression Free Survival Topline readout of Phase 1 trials at Year 51 Topline readout of Phase 1 trials at Year 51 vs historical comparison with monotherapy2 and vs his
Slide 10: Broad Phase II UV1 Pipeline with >650 Patients
Broad Phase II UV1 Pipeline with >650 Patients Expected Indication Clinical trial information topline Phase I Phase II Phase III Contributors readout UV1-103 With pembrolizumab Malignant melanoma - 30 patients INITIUM With ipilimumab & nivolumab Malignant melanoma H1 2023 154 patients NIPU With ipil
Slide 11: Next Steps for UV1 in Advanced or Metastatic Malignant Melanoma – INITIUM
Next Steps for UV1 in Advanced or Metastatic Malignant Melanoma – INITIUM UV1 Phase II trial INITIUM INITIUM: First line advanced or metastatic malignant 1st line treatment of patients with advanced or melanoma metastatic malignant melanoma (N=154) • Combination: nivolumab, ipilimumab • First patien
Slide 12: NIPU & DOVACC UV1 Phase II Trials
NIPU & DOVACC UV1 Phase II Trials NIPU: Second line malignant pleural mesothelioma DOVACC: Ovarian cancer, second maintenance • Combination: nivolumab, ipilimumab • Combination: olaparib, durvalumab • Contributors : NSGO/ENGOT, Astra Zeneca • Contributors: Oslo University Hospital (sponsor); BMS • P
Slide 13: FOCUS and LUNGVAC UV1 Phase II Trials
FOCUS and LUNGVAC UV1 Phase II Trials FOCUS: Metastatic or recurrent head and neck LUNGVAC: Advanced or metastatic non-small cell squamous cell carcinoma lung cancer (NSCLC) • Combination: pembrolizumab • Combination: pembrolizumab • Contributors : Sponsored by Halle University • Contributors: Spons
Slide 14: Supplementary study to INITIUM will include 20 patients
Supplementary study to INITIUM will include 20 patients • A supplementary study to the INITIUM trial will be initiated after enrollment of the 154 patients is completed • Data collected from the patients in the supplementary study • will not be part of the primary and secondary endpoint analyses of
Slide 15: TET Technology Platform and the TENDU Phase I Trial
TET Technology Platform and the TENDU Phase I Trial • The TET technology platform: ‐ allows for a beneficial safety profile and simplified administration since the antigens and adjuvant are part of the same molecule ‐ ADJUVANT technology: tetanus antigens are built into TENDU to potentiate the vacci
Slide 16: Table of Contents
Table of Contents Highlights Q1 2022 Operational Update Q1 2022 Key Financials Q1 2022 & Newsflow 16 Non-Confidential, Ultimovacs copy and distribution rights
Slide 17: Key Financials Q1 2022
Key Financials Q1 2022 Operating expenses – development and variations • R&D and IPR expenses: Underlying growth due to increased activity level in the clinical development program, but quarterly variations due to milestone payments in large projects • Payroll expenses: Underlying expenses fairly st
Slide 18: Key financials
Key financials Comments: Key financials per Q1-2022 - Ultimovacs Group Payroll expenses NOK (000) Q1-21 Q1-22 FY21 ▪ Lower personnel costs in Q1-22 compared to Q1-21 Total revenues - - - due to reversal of social security tax related to Payroll and payroll related expenses 12 203 11 384 61 916 optio
Slide 19: Key financials – operating cash flow
Key financials – operating cash flow NOK (000) – Negative amounts Comments: • The negative operating cash flows have increased steadily since Q1-21 due to higher activity in the broad clinical development program, including initiation of sites and increased patient recruitment in the four ongoing ph
Slide 20: Key financials – quarterly overview
Key financials – quarterly overview Key financials per Q1-2022 - Ultimovacs Group NOK (000) Q1-21 Q2-21 Q3-21 Q4-21 Q1-22 Total revenues - - - - - Payroll and payroll related expenses 12 203 14 514 23 314 11 885 11 384 External R&D and IPR expenses (incl. grants) 16 012 20 588 16 031 35 538 14 725 O
Slide 21: Expected News Flow and Milestones: Key value inflection points
Expected News Flow and Milestones: Key value inflection points during the next 12-24 months 2021 2022 2023 2024 Q4 MALIGNANT Phase I, UV1–103 Phase I, UV1–103 Cohort 1 Phase II, INITIUM MELANOMA H1: Topline results 2-yr update Q3: 2-yr OS update (all 30 patients) Fast Track + Orphan Q4: Cohort 1, 3-
Slide 22: Key Takeaways from the Q1 2022 Report
Key Takeaways from the Q1 2022 Report • INITIUM and NIPU on track to expected topline readout during H1 2023 with good patient enrollment • Extended patent protection in the US for UV1 when used as combination treatment • Complete disappearance of tumors observed in yet another patient in UV1-103, r
Slide 23: Q&A
Q&A
Slide 24: For questions
Enabling the Immune System to Fight Cancer Inc For questions Carlos de Sousa, CEO Anne Worsøe, Head of IR carlos.desousa@ultimovacs.com ir@ultimovacs.com +47 908 92507 +47 906 86815 www.ultimovacs.com