Evaxion Biotech (EVAX) Investor Update summary

Strategic partnership and business update

• Entered a transformative partnership with MSD, integrating AI-immunology-designed vaccine candidates EVX-B2 and EVX-B3 into MSD's pipeline, with MSD assuming full responsibility post-option exercise.

• The agreement includes a $3.2 million upfront payment, up to $10 million in 2025 upon option exercise, and potential milestone payments up to $592 million per product, plus low single-digit royalties on sales.

• MSD, a global leader in vaccines and Evaxion's largest shareholder, has been collaborating with Evaxion since 2023.

• The partnership validates the AI immunology platform and pipeline, providing significant financial and strategic value, and accelerates development for diseases with high unmet needs.

• Evaxion will host a conference call and webcast on September 27, 2024, to discuss the agreement and recent milestones.

Vaccine candidate and market insights

• EVX-B2 targets gonorrhea, classified as an urgent threat by the CDC due to antibiotic resistance and lack of vaccines, with a global market estimated at $2.1 billion by 2027.

• EVX-B2 has shown preclinical efficacy in animal models and against multiple Neisseria gonorrhoeae strains; EVX-B3 targets an undisclosed bacterial pathogen with no current vaccine.

• The EVX-B3 program, initiated in collaboration with MSD, is in late-stage preclinical development, addressing a pathogen responsible for recurrent infections and severe complications.

• Infectious disease candidates (EVX-B1 for S. aureus, EVX-B2 for N. gonorrhoeae) showed high immunogenicity and significant protection in preclinical models.

• Multiple assets are ready for partnering, with ongoing collaborations and licensing agreements in place.

Pipeline and clinical progress

• EVX-01, a personalized cancer vaccine, showed a 69% overall response rate in phase 2 for metastatic melanoma, with positive safety and immunogenicity data.

• EVX-02, a DNA-based vaccine, demonstrated relapse-free outcomes and robust T-cell responses in all phase 1/2 completers.

• EVX-03, a first-in-class ERV vaccine, completed preclinical toxicology without concerns and targets a novel class of tumor antigens.

• Achieved several milestones in September, including the launch of EDEN 5.0, preclinical proof of concept for mRNA-based EVX-B2, and positive phase II one-year data for EVX-01 in advanced melanoma.

• mRNA-based EVX-B2 demonstrated targeted immune response in preclinical studies, supporting the platform's delivery modality agnosticism.