🧾 What This Document Is

This is Pharvaris N.V.'s Annual Report (Form 20-F) for the fiscal year ended December 31, 2025. It's a comprehensive filing required by the SEC for foreign companies listed on U.S. exchanges. Think of it as the company's annual "report card" and detailed operational manual for investors. It includes audited financials, a deep dive into the business, and a frank discussion of all the major risks they face.

👉 Why it matters: This document is the single most important source for understanding Pharvaris's financial health, pipeline progress, strategy, and the hurdles it must overcome. It's not just numbers; it's the full story in one package.

🏢 What The Company Does

👉 In simple terms… Pharvaris is a biotechnology company focused on developing novel oral therapies for Hereditary Angioedema (HAE). HAE is a rare, genetic disorder causing severe, unpredictable swelling attacks. Currently, many patients rely on injectable treatments. Pharvaris's goal is to offer convenient pill-form alternatives.

The company is developing two main product candidates:

• PHVS418 (sebetralstat): An on-demand treatment taken at the first sign of an attack.
• PHA121: A prophylactic (preventive) treatment taken regularly to reduce attack frequency.

They are a clinical-stage company, meaning their products are being tested in humans but are not yet approved for sale. Their headquarters are in Leiden, the Netherlands.

💰 Financial Highlights

The company reports in Euros (€) using International Financial Reporting Standards (IFRS). As a clinical-stage biotech, the story is about investment and spending, not profit.

• Cash Position: A critical metric. They ended 2025 with €318.5 million in cash and cash equivalents. This "runway" funds their operations and clinical trials.
• Research & Development (R&D) Expenses: The biggest cost center. R&D expenses were €107.7 million for 2025, up from €84.1 million in 2024. This increase reflects the advancing and expanding clinical programs for their lead candidates.
• Net Loss: The company reported a net loss of €129.0 million for 2025, compared to a loss of €96.5 million in 2024. This is typical for a biotech funding late-stage trials.
• Shares Outstanding: As of December 31, 2025, there were 65,210,590 ordinary shares outstanding.

👉 Key takeaway: Pharvaris is burning cash to fund expensive clinical trials. Its financial health is measured by the size of its cash pile relative to its spending rate.

🚀 Key Moves & Strategy

The filing outlines several strategic priorities:

• Advancing Clinical Trials: The primary focus is on executing Phase 3 clinical trials for PHVS418 (sebetralstat) for on-demand treatment. They also plan to advance PHA121 for prophylaxis.
• Preparing for Commercialization: While still in trials, the company is laying groundwork for potential product launches, including regulatory strategies and early commercial planning.
• Maintaining Financial Flexibility: The company notes its use of equity offerings (like the 2024 IPO follow-on) and its at-the-market (ATM) program with Morgan Stanley & Co. LLC and Leerink Partners LLC to raise funds as needed.

👉 The signal: They are in the high-stakes, high-cost "execution phase" of drug development. Success hinges on positive clinical trial results.

📦 Financial Position & Capital Structure

Beyond cash, the balance sheet reveals:

• Assets: Total assets were €342.9 million at year-end 2025, primarily consisting of cash and €16.1 million in fixed assets (like lab equipment).
• Liabilities: Total liabilities were €78.5 million, including €33.8 million in non-current provisions and liabilities (mostly for accrued clinical and R&D expenses) and €44.7 million in current liabilities.
• Equity: Shareholders' equity was €264.4 million. The company has authorized but unissued shares, and has pre-funded warrants associated with its earlier financing.

🔮 What's Next & Pipeline Focus

The company's future is all about its clinical pipeline and regulatory interactions:

• PHVS418 (sebetralstat): Topline data from the Phase 3 study (RAPIDe 3) is the next major catalyst. They plan to submit regulatory applications (e.g., to the FDA and EMA) based on these results, aiming for approvals in 2026/2027.
• PHA121: They are conducting a Phase 2 dose-ranging study and plan to initiate a Phase 3 program subsequently.
• Regulatory Path: The company is preparing for interactions with global health authorities, including the U.S. FDA and the European Medicines Agency (EMA).

⚖️ Big Picture: Strengths & Risks

👍 Strengths:

• Focused Mission: Clear goal of addressing the HAE market with novel oral therapies.
• Advanced Pipeline: Lead candidate PHVS418 is in Phase 3, nearing a potential regulatory submission.
• Strong Cash Runway: The €318.5 million cash position provides funds to operate into 2027, based on their projected spending.
• Experienced Team & Partners: Backed by specialized biotech investors and collaborators.

⚠️ Risks (The Major Headwinds):

• Clinical/Regulatory Failure: The #1 risk. If PHVS418 or PHA121 fail in trials or are not approved by regulators, the company's value proposition collapses.
• Competition: The HAE market has existing approved therapies (injectables and other orals) and other companies developing new treatments.
• Commercialization: Even if approved, successfully launching a drug is expensive and uncertain. They must gain market acceptance and reimbursement.
• Cash Consumption: They are spending heavily. If trials are delayed or costs overrun, they may need to raise more money, diluting existing shareholders.
• Reliance on Third Parties: They depend on contract research organizations (CROs) and manufacturers. Problems at these partners could delay everything.

🧠 The Analogy

Pharvaris is like a high-performance Formula 1 team in the middle of the season. They've designed and built a promising car (their oral drug candidates), have a talented crew (management & partners), and have secured sponsorship funding (their cash pile). Right now, they're on the track pushing the car to its limits in a critical race (Phase 3 trials). The outcome of this race—whether they finish first, break down, or crash—will determine if they win the championship (get FDA approval) and move on to commercialize their victory.

📇 Key Contacts & People

• Berndt Modig: Chief Executive Officer
  • Address: Emmy Noetherweg 2, 2333 BK Leiden, the Netherlands
  • Tel: +31 (0) 71 2036 410
• Company Contact: Berndt Modig (details above)
• Legal Counsel (for the filing):
  • Sophia Hudson, P.C.
  • Jennifer L. Lee, P.C.
  • Firm: Kirkland & Ellis LLP
  • Address: 601 Lexington Avenue, New York, NY 10022
  • Phone: (212) 446-4750
  • Fax: (212) 446-4900

🧩 Final Takeaway

Pharvaris is a well-funded, single-focus biotech company at a critical inflection point. Its entire future hinges on the upcoming Phase 3 trial results for its lead oral HAE drug, PHVS418 (sebetralstat). Positive data could pave the way for a 2026/27 launch; negative data would be a devastating setback. For investors, this is a high-risk, high-reward bet on clinical execution.