Evaxion A/S · NASDAQ:EVAX
Evaxion A/S — Evaxion Biotech — Investor Presentation (June 2024)
40 slides from Evaxion A/S's investor presentation, June 2024
Slide 1: AI-Immunology Powered Vaccines
June 2024 evaxion-biotech.com AI-ImmunologyTM Powered Vaccines AI-ImmunologyTM Powered Vaccines EVAX:NASDAQ
Slide 2: Forward-Looking Statement
Forward-Looking Statement This presentation contains forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended. The words “target,” “believe,” “expect,” “hope,” “aim,” “intend,” “may,” “m
Slide 3: About Us
About Us Click to add title 3
Slide 4: A New Approach is Needed
A New Approach is Needed • Too many people are dying from cancer, drug resistant bacteria and other infectious diseases 10 million deaths a • The demand for new and efficient medicines has never year due to been higher and will only grow cancer* • Healthcare burden continues to increase • There is a
Slide 5: Who We Are
Who We Are Founded in 2008, with the objective of decoding the human immune system to address serious unmet medical needs. Today, a pioneering clinical stage TechBio company with a validated and leading AI–platform, AI-Immunology™, for fast and effective vaccine target discovery, design and developm
Slide 6: The Time for AI-Designed Vaccines is Now
The Time for AI-Designed Vaccines is Now Traditional approaches to vaccine development, such as 'Reverse Vaccinology’, are both costly and time-consuming, and often fail to create efficacious vaccines Biological ‘Big Data’ and advancements in AI technologies have created the ideal conditions to util
Slide 7: Strong Leadership with Extensive Experience Across All Relevant Fields
Strong Leadership with Extensive Experience Across All Relevant Fields Board of Directors • Marianne Søgaard Chair, former tech lawyer and equity partner • Roberto Prego Former Teva (head of Latin America) • Lars Holtug Certified Public Accountant Chief Executive Officer Chief Financial & Chief AI O
Slide 8: Evaxion is Targeting Large Markets and Operates in a Very Active Deal Making Space
Evaxion is Targeting Large Markets and Operates in a Very Active Deal Making Space Significant unmet needs and large markets Significant deal making activities (AI and vaccines) • 10 million deaths a year due to cancer • Sanofi-Novavax Inc Licensing agreement (2024) with $500M upfront • Cancer immun
Slide 9: Investment Highlights Capital Structure
Investment Highlights Capital Structure • AI-Immunology™ is a pioneering clinically validated AI platform for vaccine discovery, design and development. Its modular Symbol (Nasdaq - ADS) EVAX architecture allows for unique scalability Stock price (as of May 31, 2024) $3.67 • Current clinical and pre
Slide 10: Our Strategy
Our Strategy 10
Slide 11: AI-Immunology Summary
AI-Immunology™ Summary • Uses advanced AI and machine learning technologies • Design and development of personalized and precision vaccine candidates • AI prediction models trained in cancer and DISEASE IMMUNE VACCINE infectious diseases DECODING RESPONSE DESIGN • Potential for one new target every
Slide 12: We Have Built a Strong Multidisciplinary Capability Set and State of the Art Facilities
We Have Built a Strong Multidisciplinary Capability Set and State of the Art Facilities Disease Biology Translational Target Discovery Medicine Clinical AI-Immunology™ Antigen Development Vaccine target discovery, Design design & development Vaccine & CMC Adjuvant Design Preclinical Development 12
Slide 13: AI-Immunology and Our Multidisciplinary Capability Set Drive Differentiation
AI-Immunology™ and Our Multidisciplinary Capability Set Drive Differentiation • Our multidisciplinary capability set allows for: VALUE OF PLATFORM • Continuous iterative learning loops • Ongoing expansion of data sets with RISK OF FAILURE proprietary data • Rapid validation of AI predictions • Full
Slide 14: Strategy: Three-Pronged Business Model Based upon AI-Immunology
Strategy: Three-Pronged Business Model Based upon AI-Immunology™ Multi-partner approach to value realization TARGETS Multi-partner approach focused around single or multiple vaccine target discovery, design and development agreements PIPELINE Own development programs for select high value programs;
Slide 15: Pipeline: Demonstrating the Performance and Scalability of Our AI-Immunology Platform
Pipeline: Demonstrating the Performance and Scalability of Our AI-Immunology™ Platform INDICATION/ STAGE OF DEVELOPMENT AI MODEL PARTNER PATHOGEN TARGET DISCOVERY PRECLINICAL PHASE 1 PHASE 2 CANCER VACCINES Metastatic melanoma Pembrolizumab supply EVX-01 (Liposomal/peptide) PIONEER™ agreement with M
Slide 16: The AI-Immunology Platform
The AI-Immunology™ Platform 16
Slide 17: The Key Areas of AI-Immunology
The Key Areas of AI-Immunology™ DISEASE DECODING IMMUNE RESPONSE DECODING VACCINE DESIGN AI-Immunology™ for fast and effective vaccine target discovery, design and development 17
Slide 18: The Building Blocks of AI-Immunology
The Building Blocks of AI-Immunology™ 1 DISEASE DECODING • Uses advanced AI and machine learning SNVs Frameshifts Gene fusions HLA loss technologies ERV antigens TME impact Clonality Expression Bacterial antigens Viral antigens Antigen conservation Treatment effect • A unique modular architecture cr
Slide 19: AI-Immunology Models
AI-Immunology™ Models PIONEER™ ObsERV™ SNVs Frameshifts Gene fusions HLA loss HLA loss ERV antigens Expression Expression Clonality Neoantigens EvaxMHC HLA typing EvaxMHC HLA typing Distance to self Antigen quality Antigen safety Personalized design Antigen quality Antigen safety Personalized design
Slide 20: Unique Building Block Architecture Enables Scaling to Other Therapeutic Areas
Unique Building Block Architecture Enables Scaling to Other Therapeutic Areas CA NC ER • Significant unmet needs remains within cancer and infectious diseases AI-Immunology™ • However, unique modular architecture of AI-Immunology™ allows easy expansion to other therapeutic areas • Ample long-term bu
Slide 21: The AI-Immunology Powered Vaccine Pipeline
The AI-Immunology™ Click to add title Powered Vaccine Pipeline 21
Slide 22: Pipeline: Demonstrating the Performance and Scalability of Our AI-Immunology Platform
Pipeline: Demonstrating the Performance and Scalability of Our AI-Immunology™ Platform INDICATION/ STAGE OF DEVELOPMENT AI MODEL PARTNER PATHOGEN TARGET DISCOVERY PRECLINICAL PHASE 1 PHASE 2 CANCER VACCINES Metastatic melanoma Pembrolizumab supply EVX-01 (Liposomal/peptide) PIONEER™ agreement with M
Slide 23: EVX-01 in Combination with Standard Therapy Shows Overall Response Rate of 67%
EVX-01 in Combination with Standard Therapy Shows Overall Response Rate of 67% in Clinical Phase 1/2 in Patients with Metastatic Melanoma Study highlights • 12 patients in total, with 8 showing an objective response to treatment (ORR 67%) • 2 complete responders • Treatment: 6 biweekly EVX-01 inject
Slide 24: EVX-01 - PIONEER Identified Vaccine Targets Highly Correlate with Survival
EVX-01 - PIONEER™ Identified Vaccine Targets Highly Correlate with Survival High prediction score of neoantigens (n=6) (N=6) Low prediction score of neoantigens (n=6) • AI response prediction (PIONEER™ score) builds on the presence of high- Progression Free Survival Fraction of patients with quality
Slide 25: EVX-01 Induces a Dose-Dependent Immune Response against the Patients' Cancer
EVX-01 Induces a Dose- Dependent Immune Response against the Patients’ Cancer Neoantigen-specific T cells (SFU) • A higher dose induced higher neoantigen immune responses which may result in stronger tumor killing activity of EVX-01 • Specific immune responses against neoantigens identified by PIONE
Slide 26: EVX-01 – Clinical Phase 1/2 Summary
EVX-01 – Clinical Phase 1/2 Summary With AI-Immunology™ identified targets we have demonstrated longer progression-free survival of patients Phase 1/2 Phase 2 High overall response rate with clinical Phase 2 initiated in metastatic response in all high dose group patients melanoma with high dose EVX
Slide 27: EVX-01 Phase 2 Trial Enrolling Patients in Australia/Europe
EVX-01 Phase 2 Trial Enrolling Patients in Australia/Europe Enrolled 16 patients with metastatic melanoma Conducted in collaboration with Merck & Co., Inc (MSD) EVX-01 Priming EVX-01 Boosting Production (To activate T-cells) (To maintain level of activated T-cells) Timeline for each W1 W12 W14 W16 W
Slide 28: Encouraging Initial EVX-01 Phase 2 Trial Results
Engouraging Initial EVX-01 Phase 2 Trial Results Response Responseto to Vaccine Neoantigens vaccine neoantigens IFNγ ELISpot, background subtracted 2000 • Initial data from five patients*: SFUs per 1 x 106 PBMCs • Confirm the favorable safety profile of EVX-01 1500 • Neoantigen specific T-cell react
Slide 29: EVX-02 – First DNA-Based Personalized Cancer Vaccine Shows Positive Clinical Readout
EVX-02 – Evaxion’s First DNA-Based Positive Clinical Personalized Cancer Vaccine Shows Readout* Positive Clinical Readout Study Overview • All 10 EVX-02 completers were relapse-free at last assessment • Phase 1/2 clinical trial of EVX-02 + nivolumab (Opdivo™/standard of care) as adjuvant therapy aft
Slide 30: EVX-03 – Believed To Be First Ever Personalized ERV Vaccine
EVX-03 – Believed To Be First Ever Personalized ERV Vaccine DNA-based personalized vaccine armed with molecular immune adjuvant, neoantigens and ERVs • Molecular immune adjuvant attracts antigen presenting cells and augments antigen presentation • The unique technology is fully owned, patent protect
Slide 31: EVX-03 – Addition of ERVs Resulted in Very Promising Preclinical Data
EVX-03 – Addition of ERVs Resulted in Very Promising Preclinical Data ERV-Based DNA Vaccine Prevents High ERV Burden is Associated with Tumor Growth in a Preclinical Better Survival in Patients with Few Cancer Model Tumor Mutations (Low TMB) • ERVs are ancient viruses that have 700 integrated into t
Slide 32: Precision Cancer Vaccine Concept Developed
Precision Cancer Vaccine Concept Developed Based on a novel class of tumor antigens • Precision cancer vaccine concept developed based on a novel class of tumor antigens, named Endogenous Retroviruses, ERVs • This novel vaccine concept allows patient with similar tumor profiles to be treated with th
Slide 33: EVX-B1 – S. aureus Vaccine Candidate Demonstrates High Immunogenicity and Significant Protection
EVX-B1 – S. aureus Vaccine Candidate Demonstrates High Immunogenicity and Significant Protection • Multi-component S. aureus vaccine Mouse sepsis model candidate for prevention of Skin and Soft Tissue Infections (SSTI) 100 EVX-B1 • Induction of high IgG titers and Adjuvant 80 potent T-cell response
Slide 34: EVX-B1 – Encouraging Results for Vaccine Antigens Against Staphylococcus aureus Infection
EVX-B1 – Encouraging Results for Vaccine Antigens Against Staphylococcus aureus Infection • Evaxion and its undisclosed collaborator tested Evaxion designed vaccine antigens against Staphylococcus aureus (S. aureus) in a clinically relevant animal model of surgical site infections • The vaccine anti
Slide 35: EVX-B2 – N. gonorrhoeae Vaccine Candidate Induce Significant Protection
EVX-B2 – N. gonorrhoeae Vaccine Candidate Induce Significant Protection and Shows Broad Neutralization Capacity Vaginal colonization model • Multi-component N. gonorrhoeae vaccine candidate containing two 106 Adjuvant top-ranked EDEN™ candidates EVX-B2 Bacterial burden (CFU) 105 • Significant protec
Slide 36: Intellectual Property
Intellectual Property 36
Slide 37: Evaxion's Intellectual Property Portfolio Broadly Covers AI and Vaccine Candidates
Evaxion’s Intellectual Property Portfolio Broadly Covers AI and Vaccine Candidates for Cancer and Infectious Diseases Evaxion Biotech A/S holds an extensive intellectual property (IP) portfolio The IP portfolio covers strategic parts of the AI-Immunology™ platform and compositions of matter, methods
Slide 38: Summary
Summary 38
Slide 39: Several Important Near-Term Milestones
Several Important Near-Term Milestones Milestones Target EVX-B1 Conclusion of final MTA study with potential partner Q1 2024 AI-Immunology™ Launch of EDEN™ model version 5.0 Mid 2024 EVX-B2-mRNA EVX-B2-mRNA preclinical Proof-of-Concept obtained Q3 2024 EVX-01 Phase 2 one-year readout Q3 2024 Conclus
Slide 40: Evaxion - Summary
Evaxion - Summary • AI-Immunology™ is a pioneering clinically validated AI platform for vaccine discovery, design and development. Its modular architecture allows for unique scalability • Current clinical and preclinical pipeline offers several value triggers: • EVX-01 Phase 2 one-year readout in me