Zelluna Asa · OSL:ZLNA
Zelluna Asa — Merger or Acquisition (December 2024)
41 slides from Zelluna Asa's merger presentation, Dec 18, 2024
Slide 1: Business combination of Zelluna and Ultimovacs
Business combination of Zelluna and Ultimovacs Webcast presentation, December 18, 2024
Slide 2: Disclaimer (I/II)
Disclaimer (I/II) THIS PRESENTATION AND ITS CONTENTS ARE NOT FOR PUBLICATION, DISTRIBUTION OR RELEASE, IN WHOLE OR IN PART, DIRECTLY OR INDIRECTLY, IN AUSTRALIA, CANADA, HONG KONG, JAPAN OR THE UNITED STATES OR ANY OTHER JURISDICTION IN WHICH THE RELEASE, PUBLICATION OR DISTRIBUTION WOULD BE UNLAWFU
Slide 3: Disclaimer (II/II)
Disclaimer (II/II) Neither this Presentation, any copy of it nor the information contained herein is being issued nor distributed directly or indirectly to or into Canada, Australia, Hong Kong or Japan, the United States, or any residents thereof, or any other jurisdiction in which such distribution
Slide 4: A business combination leveraging the strengths of both companies
A business combination leveraging the strengths of both companies ▪ Proprietary, novel cell therapy platform; lead asset nearing clinic ▪ Clinical development execution Worlds first lead asset for the treatment of multiple solid cancers Clinical execution, multiple studies, 100s of patients across a
Slide 5: Namir Hassan, CEO Zelluna Immunotherapy
Namir Hassan, CEO Zelluna Immunotherapy ▪ PhD, University of Oxford, Immunology ▪ 20+ years of biotech and pharma industry experience; building organizations creating company value ▪ 15 years in biotech’s developing TCR based therapies; operational and corporate roles ▪ Early developer of KIMMTRAK,
Slide 6: Zelluna developing the next era of cell therapies
Zelluna developing the next era of cell therapies Cell therapies have cured cancer patients Nine approvals, mainly in liquid cancer Despite successes two key challenges remain: 1) Solid cancers remain tough to treat and struggle to deliver long term responses 2) Scaling global access to treatment Ze
Slide 7: Zelluna developing the next era of cell therapies
Zelluna developing the next era of cell therapies Game changing World leading cell therapy platform, leveraging the clinical successes, that may provide transformative treatments to platform solid cancer patients on a global scale Land grab therapeutic Strong IP position provides an unprecedented op
Slide 8: Agenda
Agenda I. TCR-NK platform 8 I. Introduction to cell therapy 8 II. TCR-NK 15 III. Patent estate 19 IV. Lead asset: Z1-MA4-1 23 V. Development pipeline 29 II. MultiClick 31 III. Summary 36
Slide 9: Cell therapies – background to an exciting treatment modality with curative potential
Cell therapies – background to an exciting treatment modality with curative potential Cell therapy has delivered Cell therapies have delivered game changing results with the longest-lasting responses in late-stage cancer patients, some game changing results… considered “cured” …opening for accelerat
Slide 10: Cell therapies being approved with <100 patients accelerates path to market
Cell therapies being approved with <100 patients accelerates path to market Product: Breyanzi Indication: Refractory Mantle Cell Lymphoma Registration data set: 68 patients (single arm study) Cost of (one time) treatment: $487,477 Product: Kymriah Indication: B-cell Precursor Acute Lymphoblastic Leu
Slide 11: Saving lives with cell therapies: huge opportunity in solid cancer space
Saving lives with cell therapies: huge opportunity in solid cancer space CAR based therapies TCR based therapies Total cancer burden 7 approved cell therapies for liquid cancers 2 approved cell therapies for solid cancers (both T Cell Receptor based) 10% Liquid Cancer 90% Solid Cancer Solid cancer r
Slide 12: The biology problem: tumours are diverse eventually escaping treatment
The biology problem: tumours are diverse eventually escaping treatment • Tumours are diverse (heterogeneous), evolve over time, and contain a mix of cells with different expression profiles of proteins1 Antigen positive Antigen negative HLA1 negative Note: 1) HLA: Human Leukocyte Antigen Non-Confide
Slide 13: T Cell Receptor (TCR) therapies can shrink tumours but cancers return
T Cell Receptor (TCR) therapies can shrink tumours but cancers return • TCR targeted therapies have shown tumour shrinkages across various solid cancers Antigen positive Antigen negative HLA1 negative Note: 1) HLA: Human Leukocyte Antigen Non-Confidential 13
Slide 14: New treatments needed that TARGET a tumour and BROADLY detect cancers
New treatments needed that TARGET a tumour and BROADLY detect cancers • However, most patients with advanced solid tumours showing initial response to treatment will eventually relapse • This is because current targeted therapies are triggered by a single antigen which can be lost or not expressed i
Slide 15: Agenda
Agenda I. TCR-NK platform 8 I. Introduction to cell therapy 8 II. TCR-NK 15 III. Patent estate 19 IV. Lead asset: Z1-MA4-1 23 V. Development pipeline 29 II. MultiClick 31 III. Summary 36
Slide 16: Zelluna have built a novel cell therapy platform “TCR-NK”
Zelluna have built a novel cell therapy platform “TCR-NK” based on validated clinical components TCR + NK Nature’s “guidance system”: the T Cell Receptor (TCR) TCR-NK ✓ Combines a proven targeting molecule, the TCR, with the most ▪ The TCR is a clinically proven guidance system shown potent killer c
Slide 17: Zelluna’s TCR-NK approach provides solutions to major cell therapy challenges
Zelluna’s TCR-NK approach provides solutions to major cell therapy challenges Antigen positive Antigen / HLA negative TARGETING SOLID TUMOURS WITH COST EFFICIENT SCALING AND 1 TCRs 2 BROAD CANCER DETECTION 3 REDOSING POTENTIAL ▪ TCR-NK can detect cancers in ▪ TCR based therapies are clinically ▪ TCR
Slide 18: TCR-NK platform proven to kill diverse tumours where clinical T cell benchmark falls short
TCR-NK platform proven to kill diverse tumours where clinical T cell benchmark falls short (video) T cell clinical benchmark TCR-NK (Zelluna lead asset) Mix of cancer cells (epidermoid carcinoma) to mimic a tumour (red cancers present the target, green cancers do not) TCR-NKs kills diverse cancers w
Slide 19: Agenda
Agenda I. TCR-NK platform 8 I. Introduction to cell therapy 8 II. TCR-NK 15 III. Patent estate 19 IV. Lead asset: Z1-MA4-1 23 V. Development pipeline 29 II. MultiClick 31 III. Summary 36
Slide 20: Zelluna’s patent estate provides multilayered product protection
Zelluna’s patent estate provides multilayered product protection Unique protection of a therapeutic space TCR-NK concept patent ▪ Claims any TCR/CD3 complex expressed in any NK cell ▪ Granted in the most relevant commercial territories apart from China ▪ Exclusive license from Inven2 / Oslo Universi
Slide 21: Zelluna’s TCR-NK platform: huge value potential to validate and “land grab” an entire field
Zelluna’s TCR-NK platform: huge value potential to validate and “land grab” an entire field Allogeneic ("off the shelf") Approaches TCR-NK Commentary CAR-NK (patent protected)* ✓ TCR-NK concept patent provides an opportunity to clinically validate and “land grab” the entire TCR-NK field ✓ Compare to
Slide 22: Roche acquires Poseida, a phase I “off the shelf” cell therapy company for ~$1.5 billion
Roche acquires Poseida, a phase I “off the shelf” cell therapy company for ~$1.5 billion Deal highlights Poseida pipeline (mostly liquid cancers) ▪ Poseida is a listed ($PSTX) US, Phase I clinical company developing “off the shelf” INDICATIONS PRECLINICAL IND- Phase 1 Phase 2 ENABLING CAR-T products
Slide 23: Agenda
Agenda I. TCR-NK platform 8 I. Introduction to cell therapy 8 II. TCR-NK 15 III. Patent estate 19 IV. Lead asset: Z1-MA4-1 23 V. Development pipeline 29 II. MultiClick 31 III. Summary 36
Slide 24: The target for the lead asset ZI-MA4-1: MAGE-A4, the most well validated solid cancer target for TCRs
The target for the lead asset ZI-MA4-1: MAGE-A4, the most well validated solid cancer target for TCRs Potential Evidence Competition 1 Market >50,0001 >100 of potentially eligible patients of patients with solid cancers show responses to Approval across range of solid cancers though can only manage
Slide 25: Market opportunity targeting MAGE A4
Market opportunity targeting MAGE A4 Potential MAGE A4 + Mortality Northern Potential MAGE A4 + patients factored for 5-year overall survival Indication America and Western MAGE A4 expression2 patients HLA3 (potential rate regional/distant5 Europe1 treatable) Esophageal 49 871 33% 16 457 6 748 25% /
Slide 26: Positive pre-IND with FDA derisking path to clinic - major milestone for a novel platform
Positive pre-IND with FDA derisking path to clinic - major milestone for a novel platform Preclinical ▪ Endorsement of the (in vitro) preclinical strategy Manufacturing ▪ Endorsement of the overall manufacturing strategy ▪ Agreement on key product specifications Clinical ▪ Endorsement of the startin
Slide 27: ZI-MA4-1: progress of the worlds-first scalable TCR-NK targeting MAGE-A4
ZI-MA4-1: progress of the worlds-first scalable TCR-NK targeting MAGE-A4 Science Regulatory Clinical Outperforms clinical Positive pre-IND Lung, Head, Neck benchmark FDA validated preclinical, & Ovarian manufacturing and clinical Collaborating with world- Kills diverse tumors – a strategies renowned
Slide 28: Clinical indications prioritized for first in human study with ZI-MA4-1
Clinical indications prioritized for first in human study with ZI-MA4-1 Guided by Expert Advisors Prioritized indications ▪ Prof Dirk Jäger (Medical Director of the National Center for Tumor Diseases ▪ Non-small Cell Lung Cancer (NCT) Heidelberg) ▪ Head and Neck Cancer ▪ Dr Omid Hamid (Chief of Tran
Slide 29: Agenda
Agenda I. TCR-NK platform 8 I. Introduction to cell therapy 8 II. TCR-NK 15 III. Patent estate 19 IV. Lead asset: Z1-MA4-1 23 V. Development pipeline 29 II. MultiClick 31 III. Summary 36
Slide 30: Zelluna TCR-NK Pipeline
Zelluna TCR-NK Pipeline The only company developing TCR-NKs on the validated cancer targets MAGE-A4, KKLC1 and PRAME PLATFORM PROGRAM TARGET INDICATIONS DISCOVERY PRECLINICAL CLINICAL NSCLC, Ovarian, ZI-MA4-1 MAGE-A4 H&N Syn. Sarcoma Breast, Gastric, TCR-NK ZI-KL1-1 KK-LC-1 Lung, Pancreatic, Cervix
Slide 31: Agenda
Agenda I. TCR-NK platform 8 I. Introduction to cell therapy 8 II. TCR-NK 15 III. Patent estate 19 IV. Lead asset: Z1-MA4-1 23 V. Development pipeline 29 II. MultiClick 31 III. Summary 36
Slide 32: MultiClick: a result of years of R&D
MultiClick: a result of years of R&D ▪ The initial expansion plans for our pipeline led to the development of a novel conjugation technology ▪ To scale our platform technology (TET), we developed our own novel conjugation technology based on Nobel prize-winning Click Chemistry ▪ The key benefits of
Slide 33: Ultimovacs is pioneering a conjugation technology platform through flexible click-chemistry
Ultimovacs is pioneering a conjugation technology platform to create targeted drug candidates through flexible click-chemistry Ultimovacs is pioneering a conjugation technology platform to create targeted drug candidates through flexible click-chemistry Click-chemistry enabled technology for the mod
Slide 34: Flexible coupling and on-target delivery
Flexible coupling and on-target delivery Example MultiClick Conjugate ▪ The MultiClick platform consists of a flexible core molecule that can be selectively coupled to several modules Core ▪ Each module can consist of a defined multiple of: Module 2 – Targeting units (i.e. a molecule to guide the co
Slide 35: Favorable CMC
Favorable CMC MultiClick CMC Manufacturing MultiClick core undergoes fast, one-pot click chemistry conjugation in aqueous solution at Process ambient temperature to create synthetic drug conjugates Controlled Inexpensive Components can be analyzed separately To manufacture MultiClick conjugates befo
Slide 36: Agenda
Agenda I. TCR-NK platform 8 I. Introduction to cell therapy 8 II. TCR-NK 15 III. Patent estate 19 IV. Lead asset: Z1-MA4-1 23 V. Development pipeline 29 II. MultiClick 31 III. Summary 36
Slide 37: Key investment highlights
Key investment highlights 1 Proprietary “off-the-shelf” cell therapy platform targeting solid tumours with curative potential and broad patient reach 2 Compelling pre-clinical cancer killing data outperforming clinical benchmarks for high value cancer markets 3 Robust IP, including TCR-NK concept pa
Slide 38: Zelluna company objectives
Zelluna company objectives To bring to patients transformative “off the shelf” TCR-NK cell therapies for the treatment of solid cancers Advance world's first TCR-NK program, ZI-MA4-1 into first-in-human clinical studies treating solid cancers; leverage 1 established and experienced clinical team 2 D
Slide 39: Key milestones / value inflections
Key milestones / value inflections 2024 Q1 IN-LICENSING PRAME TCR Q2 POSITIVE PRE-IND Q3 CRITICAL PRECLINICAL DATA ON LEAD COMPLETED 2026 (with limited further funds) 1H INITIAL CLINICAL READOUTS Q1 KKLC1 SECOND PROGRAM IN 2023 VITRO PACKAGE 2H EARLY MANUFACTURNG Q4 PRAME THIRD PROGRAM IN PROCESS TR
Slide 40: CEO / CFO and Board proposal
CEO / CFO and Board proposal Key management – CEO & CFO Proposed Board composition Anders Tuv, Chairman of the Board Anders Tuv is the Managing Director of Radforsk Invest, a life science investment company with a focus on cutting edge immunotherapies and precision medicines. A seasoned entrepreneur
Slide 41: Transaction: business combination of Ultimovacs and Zelluna to create a listed Company
Transaction: business combination of Ultimovacs and Zelluna to create a listed Company with the name “Zelluna ASA” Objectives Largest 1▪ Advance world's first TCR-NK cell therapy program Attraction Notable owners Listing Attraction owner into first-in-human clinical studies treating solid cancers; l