Evaxion A/S · NASDAQ:EVAX
Evaxion A/S — Evaxion Biotech — Investor Presentation (March 2023)
31 slides from Evaxion A/S's investor presentation, March 2023
Slide 1: March, 2023
March, 2023 evaxion-biotech.com EVAXION 1
Slide 2: Forward-looking statements
Forward-looking This announcement 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,” “might,” sta
Slide 3: We aspire to lead the exploration of AI to develop superior immunotherapies
We aspire to lead the exploration of AI to develop superior immunotherapies for patients in need Driving the development of AI platforms for target discovery in cancer and infectious diseases Advancing a clinical pipeline of personalized cancer immunotherapies Accelerating the development of novel v
Slide 4: Personalized cancer immunotherapy – a new drug optimized for each patient
Personalized cancer immunotherapy – a new drug optimized for each patient PIONEER DNA Sample from identifies Manufacturing Treatment in sequencing for tumor and optimal of personalized combination Anti-tumor tumor mutation healthy tissue neoantigens for cancer with standard effect identification tar
Slide 5: PIONEER – Clinically validated AI platform for personalized cancer immunotherapy
PIONEER – Clinically validated AI platform for personalized cancer immunotherapy Step 1: Identifying Step 4: Neoantigen tumor specific processing and PIONEER identifies optimal neoantigens for mutations presentation in MHC T-cell activation and anti-tumor effect in (neoantigens) each patient Key bio
Slide 6: PIONEER outperforms public tools
PIONEER outperforms public tools PIONEER vs best public tools à The best publicly available tools are only capable of identifying 2.6 correct neoantigens in the top 10 à In comparison, PIONEER identified 8.7 correct neoantigens in the top 10 à A superior prediction is anticipated to result in an enh
Slide 7: Business model
Business model Evaxion royalties Commercialization by partner Out-licensing: upfront and milestones Pre-clinical or clinical proof of concept Discovery based on AI 7 © Evaxion Biotech A/S. All rights reserved worldwide. Copenhagen, Denmark, 2022.
Slide 8: Immunotherapy Pipeline
Immunotherapy Pipeline Internal development of oncology programs while advancing infectious disease programs in partnerships 8 © Evaxion Biotech A/S. All rights reserved worldwide. Copenhagen, Denmark, 2022.
Slide 9: EVX-01 Strong interim data in clinical phase I/II
EVX-01 Individual patient Strong interim data in clinical phase I/II Study in brief • Metastatic melanoma • EVX-01 biweekly x 6 + anti-PD-1 • Interim data from 9 patients • Neoantigen-specific immune response in all patients • Tumor reduction in 6 out of 9 patients • Good safety and tolerability 9 ©
Slide 10: EVX-01 Promising efficacy data in Phase 1/2a
EVX-01 Promising efficacy data in Phase 1/2a 76% of the administered neoantigens induced reactive T cells of which 83% were de novo responses Correlation between EVX-01 activated T cells and clinical response 10 © Evaxion Biotech A/S. All rights reserved worldwide. Copenhagen, Denmark, 2022.
Slide 11: EVX-01 A patient case
EVX-01 A patient case Patient Status Scan at enrollment 64 years Stable disease after 10 months with anti-PD1 L 10mm Effect Strong immune activation Scan 1 year after by EVX-01 starting EVX-01 L 0mm Diagnosis Result Stage IV metastatic melanoma Complete response 11 © Evaxion Biotech A/S. All rights
Slide 12: EVX-01 Global clinical phase 2b trial started
EVX-01 Global clinical phase 2b trial started Locations: Clinical sites in Australia, Europe, USA Trial Population: 80 patients with metastatic melanoma Status: Enrollment started in Australia in September 2022 In partnership with Merck & Co., Inc (MSD) Interim readout H2 2023 12
Slide 13: EVX-01 Phase 2b trial design & projected timelines
EVX-01 Phase 2b trial design & projected timelines 13
Slide 14: EVX-02 A personalized DNA-based cancer immunotherapy in Phase 1/2
EVX-02 Interim A personalized DNA-based cancer readout immunotherapy in Phase 1/2 Well tolerated in all patients Neoantigen-specific T-cell responses in all patients EVX-02 + nivolumab as adjuvant therapy T-cell responses robust after melanoma and long lasting resection EVX-02 Proof of mechanism for
Slide 15: EVX-03 Our next-gen DNA-based neoantigen immunotherapy with APC-targeting unit
EVX-03 Our next-gen DNA-based neoantigen immunotherapy with APC-targeting unit Directing APCs to neoantigens augments antigen presentation APC-targeting accomplished through immune activating units in the DNA EVX-02 EVX-03 The technology is fully owned, patent protected, and with broad utility for v
Slide 16: EVX-03 Highly effective and safe in preclinical models
EVX-03 Highly effective and safe in preclinical models Highly effective in preclinical models • Strong antitumor effect* • Superior potency to 1st generation DNA vaccine • Durable neoantigen-specific T- cell response • GLP toxicology completed without concerns • Start of clinical phase 1 planned • f
Slide 17: Immuno-oncology pipeline in brief
Immuno-oncology pipeline in brief Three personalized cancer immunotherapies, Partnership opportunities generated with the PIONEER AI platform • EVX-01 Phase 2b for metastatic melanoma – • Co-development of clinical assets 67 % ORR in Phase 1/2a • Out-licensing of APC-targeting DNA • EVX-02 Phase 1/2
Slide 18: Competitor landscape
Competitor landscape Evaxion strongly positioned in personalized neoantigen vaccine field Company Format Phase Gritstone Bio ChAd1 prime/samRNA2 boost 2/3 Moderna/Merck mRNA 2b Evaxion Peptide 2b BioNtech/Roche mRNA 2 Evaxion DNA 1/2 Nykode/Roche DNA 1/2 Geneos Therapeutics DNA 1/2 NEC ONCOLmmunity
Slide 19: Addressing a large and growing market for therapeutic cancer vaccines
Addressing a large and Increased deal-making growing market for therapeutic cancer vaccines Cancer immunotherapy market est. to USD Gritstone-BMS clinical trial collaboration 277 billion in 2030* (2018) No financials disclosed NSCLC market est. to USD 33 billion by 2029** Nykode-Roche out-licensing
Slide 20: Immunotherapy Pipeline
Immunotherapy Pipeline Internal development of oncology programs while advancing infectious disease programs in partnerships 20 © Evaxion Biotech A/S. All rights reserved worldwide. Copenhagen, Denmark, 2022.
Slide 21: EDEN - trained to recognize shared protective features
EDEN - trained to recognize shared protective features Bacterial protein Data Truly protective Training of neural EDEN sequences curation proteins network - trained to recognize shared protective features . . . . .. . .. .. Non-protective + proteins Validated public data . . on truly protective and
Slide 22: EDEN – from platform to product
EDEN – from platform to 1. Input: Any bacterial proteome product Discovery 2. EDEN: Preclinically validated in: 3. Output: Ranking list of novel protective proteins • S. aureus (EVX-B1) • N. gonorrhoeae (EVX-B2) 4. Selection: 20-30 highest ranked proteins, vaccine Preclinical dev. • Pseudomonas aeru
Slide 23: EVX-B1
EVX-B1 S. aureus vaccine candidate demonstrating protection in challenge models Four-component S. aureus vaccine Mouse sepsis model (USA300) for prevention of skin and soft tissue infections (SSTI) Highly significant protection in lethal USA300 sepsis model High IgG titers and potent T-cell response
Slide 24: EVX-B2
EVX-B2 N. gonorrhoeae vaccine candidate demonstrating broad protection Multi-component N. gonorrhoeae vaccine candidate Vaginal colonization model (MS11) Protection against different N. gonorrhoeae strains in vaginal colonization model High level of immunogenicity Broad efficacy in panel of 50 N. go
Slide 25: RAVEN Proprietary AI platform for the design of superior vaccines
RAVEN Proprietary AI platform for the design of superior vaccines RAVEN Viral Vaccine T-cell epitopes The RAVEN platform designs broadly protective vaccines containing T-cell epitopes HLA-matched to the target human population Viral proteomic and genomic data Ability to induce: Optimized B-cell anti
Slide 26: Vaccines against bacterial infections
Vaccines against bacterial infections 2 proprietary AI platforms (EDEN and RAVEN) Additional bacterial and viral vaccine targets identify superior vaccine candidates maturing in discovery pipeline: • EVX-B2 (N. gonorrhoeae ) and portfolio of • Novel vaccine antigens with high and many other bacteria
Slide 27: Business model with multiple partnering opportunities
Business model with multiple partnering opportunities Evaxion royalties Commercialization by partner Out-licensing: upfront and milestones Pre-clinical or clinical proof of Personalized cancer concept immunotherapies EVX-01 EVX-03 Discovery Bacterial and viral vaccines based on AI EVX-B1 EVX-B2 EVX-
Slide 28: Milestones
Milestones Q2 2023 Full readout EVX-01 Phase 1/2a Q2 2023 Readout EVX-02 Phase 1/2a Q4 2023 Interim clinical readout EVX-01 Phase 2b Q4 2023 Start of clinical Phase 1 of EVX-03 28 Listed on Nasdaq NY, ticker “EVAX”, with headquarter at DTU science park, Denmark
Slide 29: Management team with extensive immunology, AI and leadership experience
Management team with extensive immunology, AI and leadership experience Chief Executive Officer Chief Financial Officer Chief Innovation Officer Chief Scientific Officer Chief Medical Officer Chief Operating Officer Per Norlén, MD, PhD Bo Karmark, MSc BA. Andreas Mattsson, MSc Birgitte Rønø, PhD Eri
Slide 30: Key facts
Key facts à Strong clinical pipeline in oncology à Broad preclinical pipeline in infectious diseases à 15 years of pioneering AI development à Strong IP portfolio securing lead candidates and AI à Proprietary APC-targeting à Multiple partnering opportunities à DNA technology 33
Slide 31: Thank You
For more information Visit us at evaxion-biotech.com evaxion-biotech.com NON-CONFIDENTIAL Thank You AI-Powered Immunotherapies