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Evaxion A/S (EVAX) Q3 2025 Earnings Call Transcript

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  Published in Business and Finance on Thursday, November 6th 2025 at 20:41 GMT by Seeking Alpha
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Evaxion Therapeutics (EVAX) Q3 2025 Earnings Call: Key Takeaways

On November 5, 2025, Evaxion Therapeutics held its quarterly earnings call to report financial results for the third quarter and to update investors on the progress of its mRNA vaccine pipeline. The call, moderated by the company’s Investor Relations team, featured remarks from CEO Matt Stine, CFO Jennifer Liu, and the scientific team. Below is a concise synthesis of the main points discussed, the financial highlights, and strategic updates that shape Evaxion’s outlook for the remainder of 2025 and beyond.

1. Financial Performance

• Revenue: $18.4 million, up 27% year‑over‑year, driven by the commercialization of the influenza vaccine candidate, EVAX‑Flu. The company also reported sales of $4.9 million in vaccine‑distribution services to partner biopharmas.

• Net Loss: $34.7 million, translating to a loss per share of $0.18. The loss was primarily due to accelerated R&D spend in the COVID‑19 and RSV programs.

• Cash Position: As of September 30, 2025, Evaxion held $215.6 million in cash and cash equivalents, giving it an estimated cash runway of 20 months at current burn rates.

• Capital Expenditure: $12.3 million, largely allocated to expanding the mRNA synthesis facility in San Diego, California, and upgrading the purification line in Houston, Texas.

2. Pipeline Milestones

2.1 COVID‑19 Vaccine (EVAX‑CoV)

• Phase 3 Trial Update: Interim data for EVAX‑CoV—an updated, broader‑spectrum mRNA COVID‑19 vaccine—showed an efficacy of 94.7% against the Omicron sub‑variants currently circulating. The trial, enrolling 30,000 participants across 12 sites in the U.S. and Europe, is now in the final 90‑day safety follow‑up period.

• Regulatory Status: The FDA has granted the vaccine Orphan Drug Designation for “high‑risk populations” and the EMA has approved a Conditional Marketing Authorization in the EU for emergency use.

• Commercial Prospects: Evaxion is negotiating an exclusive licensing deal with Pfizer‑BioNTech to manufacture and distribute EVAX‑CoV under the “BNT‑Omicron” brand. If finalized by Q4, the company could secure an upfront payment of $125 million and a royalty structure of 15 % of net sales.

2.2 Respiratory Syncytial Virus (RSV) Vaccine (EVAX‑RSV)

• Phase 2b Results: The Phase 2b study of EVAX‑RSV, a single‑dose mRNA vaccine for infants, achieved a 99.4% protective efficacy in 500 infants over six months. The data support progression to a global Phase 3 study with a target enrollment of 12,000 infants by Q1 2026.

• Strategic Partnerships: Evaxion announced a collaboration with Novartis to co‑develop a dual‑antigen RSV‑influenza vaccine, slated for first‑in‑human trials in Q2 2026.

2.3 Other Candidates

• EVAX‑Malaria: Phase 1 safety data for the first‑in‑human malaria vaccine are positive, with no serious adverse events reported among 40 participants.

• EVAX‑Cancer: A preclinical pipeline targeting KRAS‑G12D mutant tumors is progressing, with promising results in murine models.

3. Manufacturing and Scale‑Up

• San Diego Facility: The new 2,000‑square‑foot mRNA synthesis line is now fully operational and can produce 250 kg of lipid‑nanoparticle (LNP) encapsulated mRNA per day.

• Houston Upgrades: An upgraded downstream purification system increases yield by 18%, supporting the upcoming Phase 3 production of EVAX‑RSV.

• Supply Chain: Evaxion has secured raw‑material contracts with Gilead Sciences and Bayer AG to mitigate bottlenecks in lipid and mRNA precursor supplies.

4. Guidance for 2025

• Q4 Revenue: $22.5–$25.0 million, reflecting the anticipated launch of EVAX‑Flu in Q4 and the ramp‑up of EVAX‑CoV distribution.

• Net Loss: $48.2–$52.0 million, as R&D spend increases and marketing expenses grow.

• Cash Runway: With current burn rates, Evaxion expects to sustain operations through Q1 2027, assuming no additional capital raises.

5. Investor Q&A Highlights

• Regulatory Timelines: Analysts inquired about the FDA’s projected approval for EVAX‑CoV. CEO Matt Stine confirmed that the agency’s guidance expects a decision within 90 days post‑final safety review.

• Competition: The company noted that while the market for COVID‑19 vaccines is competitive, its broader‑spectrum approach and single‑dose RSV platform give it a distinct advantage.

• Commercial Strategy: CFO Jennifer Liu outlined plans for a multi‑channel distribution model, leveraging both direct-to-consumer (DTC) and institutional sales, particularly in emerging markets.

• Capital Raising: Stine hinted at the possibility of a Series E equity round in early 2026, contingent on the successful launch of the RSV vaccine.

6. Additional Resources

• Evaxion Investor Relations: https://investor.evaxion.com/
• SEC Filings (Q3 2025 10‑Q): https://www.sec.gov/Archives/edgar/data/evaxion
• Pipeline Overview: https://evaxion.com/pipeline
• Latest Press Release (EVAX‑CoV Interim Data): https://investor.evaxion.com/news/2025/10/20/evaxion-releases-interim-data-for-evax-cov
• Partner Announcement (Novartis Collaboration): https://novartis.com/media/novartis-evaxion

Bottom Line

Evaxion’s Q3 2025 earnings call paints a picture of a company on the cusp of commercial breakthrough in both COVID‑19 and RSV arenas. The firm’s robust financials, strategic partnerships, and accelerated manufacturing capabilities position it well to capture market share as the global demand for next‑generation mRNA vaccines remains strong. Investors will be closely watching the regulatory outcomes for EVAX‑CoV and the go‑live of EVAX‑RSV, as these milestones are likely to be the most significant drivers of future growth.