Zelluna Asa · OSL:ZLNA
Zelluna Asa — Ultimovacs — Q3 2021 Earnings Presentation
34 slides from Zelluna Asa's earnings presentation, Nov 11, 2021
Slide 1: Enabling the Immune System to Fight Cancer
Enabling the Immune System to Fight Cancer Third Quarter 2021 Presentation 11 November 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 Q3 2021 Operational Update Q3 2021 Key financials Q3 2021 & Newsflow 3 Non-Confidential, Ultimovacs copy and distribution rights
Slide 4: Highlights Q3 2021
Highlights Q3 2021 New Phase II trial in NSCLC – UV1 to be investigated with pembrolizumab • 138 patients • Drammen Hospital is the sponsor • 8-10 sites in Norway Successful Capital Raise • A private placement was successfully completed on 26 October 2021 • Gross proceeds of MNOK 270 raised Non-Conf
Slide 5: Highlights Q3 2021 (cont.)
Highlights Q3 2021 (cont.) Further 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
Slide 6: Highlights Q3 2021 (cont.)
Highlights Q3 2021 (cont.) Fast Track designation confirms our confidence in the therapeutic potential of UV1 Fast Track designation, mandates the FDA to facilitate the development and expedite review of drugs and biologics: • intended to treat serious or life-threatening conditions and • that demon
Slide 7: UV1 - Fast Track Benefits
Highlights Q3 2021 (cont.) Through the “Fast Track” designation for UV1, the following benefits are UV1 - Fast Track Benefits provided by the FDA: • Facilitates the development and expedites the review of UV1 • Enables early and frequent communication with the FDA to support UV1’s development • Prov
Slide 8: Highlights Q3 2021 (cont.)
Highlights Q3 2021 (cont.) Continued progress in the broad UV1 Phase II program • INITIUM (154 patients): Ultimovacs sponsored trial in malignant melanoma in which UV1 is combined with nivolumab and ipilimumab. • 91 patients enrolled as of 10 November 2021 (compared to 68 patients in the previous qu
Slide 9: Highlights Q3 2021 (cont.)
Highlights Q3 2021 (cont.) Covid-19 impact • The effect of the pandemic on the biotech industry and the general ability to conduct clinical trials is still uncertain and dependent on the speed of return to a more normal situation • Ultimovacs continues to monitor the impact from COVID-19 on its clin
Slide 10: Highlights Q3 2021 (cont.)
Highlights Q3 2021 (cont.) TENDU • Enrollment of the first cohort of three patients was completed in Q2 2021 • In June 2021, the Drug Safety Monitoring Board allowed the dose to be increased to 400 μg for the next three patients in cohort 2 • The first patient in the second cohort was enrolled in Se
Slide 11: Table of Contents
Table of Contents Highlights Q3 2021 Operational Update Q3 2021 Key Financials Q3 2021 & Newsflow 11 Non-Confidential, Ultimovacs copy and distribution rights
Slide 12: UV1 with strong potential to enhance standard of care for NSCLC patients
UV1 with strong potential to enhance standard of care for NSCLC patients ABOUT NSCLC • Among the most common cancer in EU5 men and women NSCLC Patient • NSCLC represents ~85% of all lung China Incidence1 33% cancers 850,000 • Poor prognosis: 5 year survival at ~25%2 US Japan 1/3 of the total NSCLC p
Slide 13: UV1 as a valuable combination treatment to pembrolizumab in NSCLC
UV1 as a valuable combination treatment to pembrolizumab in NSCLC Global NSCLC Market Value Chemotherapy • Checkpoint inhibitors (CPIs) are standard of care for advanced & recurrent NSCLC with a ~56% value share (in US$) • Pembrolizumab’s1 market share of CPIs in Value share NSCLC is ~ 67% (in US$)
Slide 14: LUNGVAC: New phase II trial of UV1 in NSCLC
LUNGVAC: New phase II trial of UV1 in NSCLC • LUNGVAC: advanced or metastatic non-small 1st line first line treatment in patients with cell lung cancer inoperable advanced or metastatic non-small cell lung cancer (N=138) - Combination: Pembrolizumab (Keytruda) - Patients: 138 patients, 8-10 hospital
Slide 15: Broad Phase II UV1 Pipeline with >650 Patients
Broad Phase II UV1 Pipeline with >650 Patients Pre- Indication Clinical trial information clinical Phase I Phase II Phase III Contributors First line metastatic With pembrolizumab malignant melanoma 30 patients First line metastatic With ipilimumab & nivolumab INITIUM malignant melanoma 154 patients
Slide 16: UV1 Phase 1: Positive 5-Year Safety and Efficacy in Malignant Melanoma
UV1 Phase 1: Positive 5-Year Safety and Efficacy in Malignant Melanoma 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 historical comparison with monot
Slide 17: Phase I UV1 + ipilimumab in Malignant Melanoma
Phase I UV1 + ipilimumab in Malignant Melanoma Strong response rates vs. historical ipilimumab data Impact on Tumor Size Topline readout from Phase I trial in malignant melanoma compared to historical ipilimumab data¹ and IPI4 study² 50% 40% 33% 30% 17-19%1 20% N=181 9%2 10% N=12 N=315 N=151 0% Obje
Slide 18: Phase I UV1 + pembrolizumab in Malignant Melanoma
Phase I UV1 + pembrolizumab in Malignant Melanoma Encouraging results with good safety and strong signals of efficacy Phase I Trial Design Key results as of Q4 2021: • Good safety profile supporting use of UV1 in combination UV1 UV1 treatments (37.5 µg GM-CSF) (75 µg GM-CSF) ‐ Safety of combination
Slide 19: Phase I UV1 + pembrolizumab in Malignant Melanoma
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) 8/301 Complete response rate (CR)
Slide 20: Phase I UV1 + pembrolizumab in Malignant Melanoma
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 Respons
Slide 21: Phase I UV1 + pembrolizumab in Malignant Melanoma
Phase I UV1 + pembrolizumab in Malignant Melanoma Encouraging OS & mPFS vs. historical pembrolizumab data Overall Survival at 12 and 24 months – Cohort 1 Median Progression Free Topline readout from Phase I trial in malignant melanoma compared to Survival historical pembrolizumab data1 100% UV1 + pe
Slide 22: Next Steps for UV1 in Advanced Malignant Melanoma – INITIUM Phase II trial
Next Steps for UV1 in Advanced Malignant Melanoma – INITIUM Phase II trial INITIUM • INITIUM Phase II combination trial with nivolumab and ipilimumab in malignant melanoma ongoing 1st line treatment of patients with advanced malignant melanoma (N=154) - Enrollment ongoing since June 2020 - 154 patie
Slide 23: NIPU & DOVACC Phase II Trials
NIPU & DOVACC Phase II Trials NIPU: Malignant pleural mesothelioma DOVACC: Ovarian cancer • Combination: nivolumab, ipilimumab • Combination: olaparib, durvalumab • Contributors: Oslo University Hospital (sponsor); BMS • Contributors : NSGO/ENGOT, Astra Zeneca • Patients: 118 from 6 sites: Norway, S
Slide 24: FOCUS and LUNGVAC Phase II Trials
FOCUS and LUNGVAC Phase II Trials FOCUS: Head and neck squamous cell carcinoma LUNGVAC: Advanced or metastatic NSCLC • Combination: pembrolizumab • Combination: pembrolizumab • Contributors : Sponsored by Halle University • Contributors: Sponsored by Drammen Hospital with Odd Hospital network Terje
Slide 25: 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 Patients with relaps
Slide 26: Table of Contents
Table of Contents Highlights Q3 2021 Operational Update Q3 2021 Key Financials Q3 2021 & Newsflow 26 Non-Confidential, Ultimovacs copy and distribution rights
Slide 27: Private Placement in October 2021
Private Placement in October 2021 • On 26 October 2021, Ultimovacs successfully carried out a private placement of 2,160,000 new shares at a subscription price of NOK 125 per share, raising gross proceeds of NOK 270 million • More than 100 investors took part in the private placement • The net proce
Slide 28: Key financials
Key financials Comments: Key financials per Q3-2021 - Ultimovacs Group Payroll expenses NOK (000) Q3-20 0 Q3-21 0 YTD20 YTD21 FY20 Total revenues - - - - - ▪ Higher cost in Q3-21 than the same period in Payroll and payroll related expenses 13 115 23 314 36 327 50 031 50 989 2020 due to: External R&D
Slide 29: Key financials – operating cash flow
Key financials – operating cash flow NOK (000) – Negative amounts Comments: • The negative operating cashflow in Q3-21 is approximately at the same level as in the previous quarters in 2021. • A further increase in negative operating cashflow related to R&D should be expected going forward with the
Slide 30: Key financials – quarterly overview
Key financials – quarterly overview Key financials per Q3-2021 - Ultimovacs Group NOK (000) Q1-20 Q2-20 Q3-20 Q4-20 Q1-21 Q2-21 Q3-21 Total revenues - - - - - - Payroll and payroll related expenses 10 015 13 197 13 115 14 662 12 203 14 514 23 314 External R&D and IPR expenses (incl. grants) 18 089 1
Slide 31: Expected News Flow and Milestones
Expected News Flow and Milestones 2021 2022 2023 2024 Q4 Cohort 1 MALIGNANT H2: Topline results 2-yr update MELANOMA Phase II INITIUM Phase I US Q3: Cohort 2, Fast Track 2-yr update designation Phase I US MALIGNANT PLEURAL H2: Topline results MESOTHELIOMA Phase II NIPU 2023 OVARIAN CANCER First pati
Slide 32: Key Takeaways from the Q3 2021 Report
Key Takeaways from the Q3 2021 Report • New Phase II trial in NSCLC – a further extension of the broad UV1 Phase II program • 5 indications, different combinations, >650 patients at close to 100 hospitals in appr. 15 countries • Further strengthening of the encouraging results from the Phase I clini
Slide 33: Q&A
Q&A
Slide 34: 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