Evaxion AS Q4 FY2024 earnings call

• Business Development: Entered a transformational partnership with MSD in September 2024, tracking towards potential option exercise in the second half of 2025; aim to secure at least two new agreements in 2025.
• R&D: EVX-01 Phase 2 trial ongoing with one-year data showing 69% overall response rate; launched novel toxin antigen predictor for AI-Immunology platform; developed precision cancer vaccine concept targeting shared tumor antigens; progress in bacterial vaccine programs EVX-B2 and B3 in collaboration with MSD; CMV vaccine program advanced with full rights acquired.
• Financing: Extended cash runway to mid-2026 via public offering and MSD investment; delisting determination from Nasdaq withdrawn, now compliant; operational cash burn in 2025 expected at $14 million, same as 2024 despite increased activity.
• Milestones: All patients completed dosing in EVX-01 trial; EVX-01 trial extended to 3 years for three-year data; AACR presentation of EVX-01 data; key milestones in 2025 include potential MSD option exercise, EVX-01 Phase 2 data, and others.

In 2024, Evaxion recorded revenue of $3.3 million, primarily from the option and license agreement with MSD. Cash and cash equivalents at the end of 2024 were $6 million, up from $5.6 million in 2023. The net loss for 2024 was $10.6 million, an improvement from the $22 million net loss in 2023. For 2025, operational cash burn is expected to be $14 million, similar to 2024, with cash runway extended to mid-2026 and potentially into 2027 if MSD exercises options.

• Cash runway extended to mid-2026, with potential to extend into 2027 if MSD exercises its options.
• Operational cash burn in 2025 is expected to be $14 million, consistent with 2024.
• Key value catalysts in 2025 include the potential MSD option exercise, EVX-01 Phase 2 data, and other upcoming milestones.

• Uncertainties associated with forward-looking statements.
• Legal documentation for loan conversion with the European Investment Bank taking longer than anticipated.
• Dependencies on successful execution of pipeline programs and partnerships.

Q: How are new pipeline candidates ensured to be partnerable?

A: It starts with identifying unmet medical need and commercial potential. Early dialogues with potential partners are held to shape preclinical packages to align with future partner requirements. For example, with ERV-based concepts and infectious disease candidates, input from potential partners is solicited early.

Q: What data should we expect from EVX-01 at AACR and what's needed for a transaction?

A: At AACR, biomarker data and additional T cell data from patients will be presented. For a transaction, the data generated from EVX-01, including ongoing trial data and confirmation of data holding up in larger Phase 3 trials, is important. Also, progress from other personalized cancer vaccines like Moderna's is watched.

Q: What cancers could be targeted with ERV vaccines?

A: Indications with high burden of shared ERV tumor antigens are being considered. More information on specific cancers will be shared by the end of 2025 as the program progresses.

Q: Will data be released for EVX-B2 and B3 ahead of MSD's decision?

A: For EVX-B2, MSD is conducting confirmatory work, so no additional data will be released. For EVX-B3, the work plan agreed in 2023 is being completed, with MSD involved in the process.