Zelluna Asa · OSL:ZLNA
Zelluna Asa — Ultimovacs — Q2 2024 Earnings Presentation
24 slides from Zelluna Asa's earnings presentation, Aug 21, 2024
Slide 1: Empower the Immune System to Fight Cancer
Empower the Immune System to Fight Cancer Second Quarter 2024 Business Update and Financial Results Ultimovacs ASA, August 21, 2024 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 expressed or implied by the forward-looking statements contained in this “Company”) for information purposes only and does not constitute an offer to presentation. Given these risks, uncertainties and other factors
Slide 3: Contents
Contents Introduction 01 Clinical update UV1 02 Novel Drug Conjugation Platform 03 Financial update 04 Newsflow 3
Slide 4: Second quarter 2024 – Summary
Second quarter 2024 – Summary • Despite disappointing results from INITIUM and FOCUS, we are still committed to bringing UV1 across the next important data point, the DOVACC readout • In August 2024, Ultimovacs reported topline results from the Phase II FOCUS trial in head and neck cancer. The trial
Slide 5: Clinical update UV1
@ultimovacs 01 Clinical update UV1
Slide 6: Background for the UV1 Phase II program
Background for the UV1 Phase II program: Capture Broad Potential and Right Development Path • Positive Phase I data with UV1 • Robust and long-lasting immune responses after UV1 vaccination • Apparent synergy with checkpoint inhibitors (CPIs) • Strong efficacy signals and beneficial safety profile s
Slide 7: Investigating UV1 across cancer multiple indications and combinations
Investigating UV1 across cancer multiple indications and combinations Phase II Phase I Indication Combination Randomized Contributors Single-arm trials controlled trials Malignant Ipilimumab INITIUM N=156 melanoma Nivolumab Ultimovacs Malignant sponsored Pembrolizumab UV1-103 N=30 melanoma trials Ma
Slide 8: Background FOCUS: HNSCC
Background FOCUS: HNSCC • Head and neck squamous cell carcinoma (HNSCC) refers to a group of malignancies arising from the linings of the head and neck region (oral cavity, pharynx, lip, sinuses, and salivary glands) • HNSCC is the 7th most common cancer globally (appx. 890.000 new cases in 2020) •
Slide 9: FOCUS: First-line head and neck cancer
FOCUS: First-line head and neck cancer Sponsor: Halle University Hospital Network Contributors: Ultimovacs Sites and countries: 10 hospitals in Germany NCT05075122 Primary endpoint: UV1 • Progression-free survival rate at 6 1L head and neck cancer Pembrolizumab months (N=50) Secondary endpoints: N=7
Slide 10: Results from the FOCUS trial
Results from the FOCUS trial • Adding Ultimovacs’ cancer vaccine UV1 to checkpoint inhibitor pembrolizumab did not meet primary or secondary endpoints in patients with metastatic or recurrent head and neck squamous cell carcinoma • UV1 continues to show a positive safety profile in line with other U
Slide 11: Background DOVACC: Ovarian cancer
Background DOVACC: Ovarian cancer • Ovarian cancer is a malignancy arising from surface epithelium in the ovaries. It is the second most common gynecologic malignancy and is the leading cause of death from gynaecological cancer. • Ovarian cancer is the 18th most common cancer overall • Standard trea
Slide 12: DOVACC: Relapsed ovarian cancer
DOVACC: Relapsed ovarian cancer Sponsor: NSGO/ENGOT Contributors: AstraZeneca, Ultimovacs Sites and countries: 35 hospitals, 10 countries in Europe NCT04742075 High-grade BRCA negative ovarian UV1 cancer, 2L maintenance Olaparib Durvalumab Primary endpoint: N=184 (N=92) • Progression-free survival •
Slide 13: LUNGVAC: First-line non-small cell lung cancer
LUNGVAC: First-line non-small cell lung cancer Sponsor: Drammen Hospital Contributors: Ultimovacs Sites and countries: 9 hospitals in Norway NCT05344209 1L advanced or metastatic non-small cell UV1 Primary endpoint: lung cancer Cemiplimab Progression-free survival N=138 (N=69) • NSCLC stage IIIB/III
Slide 14: Novel Drug Conjugation Platform
02 Novel Drug Conjugation Platform
Slide 15: Novel Drug Conjugation Platform
Novel Drug Conjugation Platform • Ultimovacs has developed a novel conjugation technology, initially formed to support the expansion of our vaccine pipeline • The novel conjugation technology is a result of several years of work by our Research and CMC teams • This flexible conjugation technology ha
Slide 16: Financial update
@ultimovacs O03 Financial update
Slide 17: Q2 2024 Key Financials
Q2 2024 Key Financials Cash and liquidity • MNOK 170/MUSD 16 in cash by end of Q2 2024 • Activity level prioritization and operational adjustments are implemented to sustain the financial runway, including a workforce reduction of approximately 40%. • The cash preservation initiatives extend the ant
Slide 18: P&L and Cash
P&L and Cash Comments Key financials per Q2-2024 - Ultimovacs Group Payroll expenses NOK (000) Q2-23 Q2-24 YTD23 YTD24 FY23 • Due to significant volatility in the company share price in Q1-2024 and Total revenues - - - - - Q2-2023, which affects the share option costs, total payroll expenses Payroll
Slide 19: Quarterly operating cash flow
Quarterly operating cash flow Comments NOK (000) – Negative amounts • The operating cash-flow in Q2 2024 was approximately MNOK -50, higher than EBIT of MNOK -45. • Continued quarterly variations should be expected. It is, however, expected that the cash flow on average will decrease significantly t
Slide 20: Quarterly overview P&L and Cash
Quarterly overview P&L and Cash Key financials per Q2-2024 - Ultimovacs Group NOK (000) Q1-23 Q2-23 Q3-23 Q4-23 Q1-24 Q2-24 Total revenues - - - - - - Payroll and payroll related expenses 21 002 4 359 24 518 25 251 -2 425 13 708 - Pa yrol l expens es not i ncl . option cos ts a nd gra nts 14 652 10
Slide 21: Newsflow
@ultimovacs 03 Newsflow
Slide 22: Newsflow and milestones
Newsflow and milestones UV1 TRIALS/OTHER PIPELINE 2024 2025 / 2026 Malignant melanoma Q2: 4-yr OS Total Phase I: UV1-103 Malignant melanoma Topline result Phase II: INITIUM March 2024 Malignant pleural mesothelioma Update at ESMO Phase II: NIPU Head and neck cancer Exp. topline result Phase II: FOCU
Slide 23: Ultimovacs is Committed to Bringing UV1 Across the Next Major Value Inflection Points
Ultimovacs is Committed to Bringing UV1 Across the Next Major Value Inflection Points and Continuing to Develop our Novel Drug Conjugation Platform • We remain committed to bringing UV1 across the next important data point, the DOVACC results expected in H1 2025 • Ultimovacs is currently developing
Slide 24: Q&A
@ultimovacs Q&A