🧾 What This Document Is

This is a 6-K filing, which is a report foreign companies like Evaxion (based in Denmark) must file with the SEC to share material news with U.S. investors. Think of it as a formal press release submitted to regulators. This specific filing announces a clinical trial milestone: they've finished collecting data from a one-year extension of a key study.

👉 Why it matters: For investors, these updates are the lifeblood of a clinical-stage biotech company. They provide the proof-of-concept data that determines if a drug has a future and can attract partnership or funding.

🏢 What The Company Does

👉 In simple terms, Evaxion is a biotech "TechBio" company that uses artificial intelligence as a super-powerful microscope to design better cancer vaccines. Their core technology is called AI-Immunology™, which acts like a highly advanced prediction engine to identify the unique markers (called neoantigens) on a patient's specific cancer. They then build a custom vaccine to train the immune system to attack those markers.

The company is focused on developing both personalized (made-for-one) and off-the-shelf cancer vaccines, as well as vaccines for infectious diseases.

🚀 Key Moves & Clinical Milestone

The headline news is that the one-year extension phase of their Phase 2 trial for the cancer vaccine EVX-01 is now complete.

• What happened: The last patient in the trial had their final scheduled doctor's visit. This doesn't mean the trial is over—patients will continue to be monitored.
• Why it's a milestone: It means all planned treatment and initial data collection phases are finished as planned. This is a crucial step on the path to getting a final, complete dataset.
• What's next: The company will now analyze all the data collected over three years and plans to present the full results in the second half of 2026.

📊 The Trial Data So Far (The "Wow" Numbers)

While we wait for the 3-year data, Evaxion highlighted the already-reported 1- and 2-year results from this same trial. These numbers are what have the biotech world watching:

• 75% Objective Response Rate (ORR): This means 12 out of 16 patients had their cancer significantly shrink or disappear.
• Complete Responses: 4 patients saw their cancer vanish completely.
• Durability: 92% of responders were still responding at the 2-year check-up. Zero relapses were observed in that period.
• Tumor Shrinkage: Tumors got smaller in 15 out of 16 patients (94%).
• Immune Activation: The vaccine triggered a strong, specific immune response in all patients, targeting the right markers 81% of the time.

👉 Why this matters: A 75% ORR in advanced melanoma is very strong, especially the durability (long-lasting response). The immune activation data proves their AI platform is correctly picking targets that the immune system can recognize.

🔍 Trial Design & The Drug's Story

EVX-01 isn't being tested alone. The trial design tells a strategic story:

• Years 1 & 2: Patients received EVX-01 + Keytruda®. Keytruda is a blockbuster immunotherapy drug from Merck (MSD). Combining with an established drug shows how EVX-01 might be used to boost standard care.
• Year 3 (The Extension): Patients received EVX-01 alone (monotherapy). This is critical—it will show if the vaccine can sustain its effect without the help of another drug, pointing to its potential standalone power.

🔮 What's Next & Implications

The company is now in the data crunching and analysis phase. The key upcoming event is the full three-year data presentation in H2 2026. Investors will be looking for:

• Whether the impressive response rates held up or even improved.
• Evidence of long-term, durable immune memory.
• Safety data from the longer follow-up.

This final dataset will determine the next steps for EVX-01: does it move into a larger Phase 3 trial? Does it attract a big pharmaceutical partner? The upcoming data is the answer to those questions.

⚖️ The Big Picture: Strengths & Risks

👍 Strengths:

• Strong Early Data: The 75% ORR and durability are eye-catching and competitive in the oncology space.
• Validated AI Platform: The high rate of immune response suggests their AI-Immunology™ platform works, making it a valuable asset for other pipeline candidates.
• Strategic Design: Testing in combination and as monotherapy provides a clearer picture of the drug's value.

⚠️ Risks & Uncertainties:

• Small Sample Size: The trial only had 16 patients, which is small. Larger trials can sometimes show different results.
• High Bar: The final 3-year data must continue to impress to support future development and commercial potential.
• Clinical-Stage Company: Evaxion is pre-revenue. Its success and funding are entirely dependent on positive clinical results like these.

🧠 The Analogy

Developing a cancer vaccine is like creating a custom security system for a specific house (the patient's tumor). Evaxion's AI platform is the smart surveillance camera that instantly identifies all the unique entry points (neoantigens). EVX-01 is the custom-fit alarm system built to guard those exact points. The trial data so far shows the alarm is working—guards are responding correctly and staying on duty. The final three-year check-up will confirm if it's a durable, long-term security solution.

🧩 Final Takeaway

Evaxion has successfully completed data collection for its lead cancer vaccine, EVX-01, building on previously stellar early results. The validation of their AI-driven design platform is the key takeaway, and the biotech world now awaits the definitive three-year data in late 2026 to judge its full potential.