Evaxion A/S · NASDAQ:EVAX
Evaxion A/S — Investor Presentation (September 2024)
40 slides from Evaxion A/S's investor presentation, September 2024
Slide 1: AI-Immunology Powered Vaccines
September 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 pioneer in fast and effective AI-powered development of new medicines
A pioneer in fast and effective AI-powered development of new medicines Multidisciplinary Broad pipeline Multi-partner capability set Pre-clinical and Three-Pronged approach to value and state of the clinical programs Business model realization art wetlab and across cancer and Several partnerships a
Slide 5: Founded as AI first-company
Founded as AI first-company 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, des
Slide 6: Targeting significant unmet needs and large markets
Targeting significant unmet needs and large markets Major challenges Global market forecasts • Lack of effective treatments for many cancer patients • No approved vaccines against S. aureus, Gonorrhoea or Cytomegalovirus (CMV) $7.4bn4 • Antibiotics resistance is continuing to increase $277bn3 • Heal
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: 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 architecture allows for unique scalability Symbol (Nasdaq - ADS) EVAX • Current clinical and preclinical pipeline offers several value
Slide 9: Our strategy
Our strategy 9
Slide 10: 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 infectious diseases • Potential for one new target every 24 hours • Platform is delivery modality agnosti
Slide 11: 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 11
Slide 12: 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 o Continuous iterative learning loops Ongoing expansion of data sets with RISK OF FAILURE o proprietary data o Rapid validation of AI predictions o Full
Slide 13: 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 14: 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 15: The AI-Immunology platform
The AI-Immunology™ platform 15
Slide 16: 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 16
Slide 17: 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 18: AI-Immunology models
AI-Immunology™ models SNVS Frameshifts Gene fusions HLA loss Expression Clonality Neoantigens PIONEER™ EvaxMHC HLA typing Distance to self Antigen quality Antigen safety Personalized design HLA loss ERV antigens Expression Cancer ObsERV™ EvaxMHC HLA typing Antigen quality Antigen safety Personalized
Slide 19: AI-Immunology: Clinically validated predictive capabilities highly correlate with survival
AI-Immunology™: Clinically EVX-01 - PIONEER™ validated predictive capabilities Identified vaccine targets highly correlate with High prediction score of neoantigens (n=6) survival (N=6) Low prediction score of neoantigens (n=6) • AI response prediction (PIONEER™ score) builds on the presence of high
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: Convincing one year phase 2 data on EVX-01 with 69% Overall Response Rate
Convincing one year phase 2 data* on EVX-01 with 69% Overall Response Rate Largest reduction in target lesion size for each patient compared to Change in target lesion size over time. Day 0 is defined as the day of the baseline scan. Lines baseline. Bars are colored according to each patient’s best
Slide 24: EVX-01 in combination with standard therapy shows objective response rate of 67%
EVX-01 in combination with standard therapy shows objective 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 inje
Slide 25: 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 26: 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 27: 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 28: Neoantigen PIONEER quality score correlates positively with T-cell responses
Neoantigen PIONEERTM quality score correlates positively with T-cell responses – initial EVX-01 phase 2 data Number of Immunogenic neoAgs during Correlation between neoAg responses and PIONEER™ EVX-01 priming neoAg quality scores 10 Immunogenic neoAgs: 1500 Pearson, r = 0.24 P = 0.03 # of immunogeni
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 based on a novel class of tumor antigens
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 – Staphylococcus aureus vaccine candidate demonstrates high immunogenicity
EVX-B1 – Staphylococcus 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-ce
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 induces 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 2024 milestones
Several 2024 milestones Milestones Target EVX-B1 Conclusion of final MTA study with potential partner Q1 2024 AI- Mid 2024 Launch of EDEN™ model version 5.0 Immunology™ (ECCB, September) Q3 2024 EVX-B2-mRNA EVX-B2-mRNA preclinical Proof-of-Concept obtained (18th Vaccine Congress, September) Q3 2024
Slide 40: Strong platform for long-term value creation
Strong platform for long- term value creation • 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 potential value triggers: o