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- **FDA Milestone Confidence**: Pre-NDA meeting in December to secure 2026 submission, with $18.8M cash runway.
- **Commercial Momentum**: 80% hospital formulary uptake and 60% surgeon utilization rate from market study.
- **Financial Strength**: Reduced debt to $2.4M, improved net loss to $7.5M, and strategic U.S. manufacturing expansion considerations.

**【CEO Summary Section】**
- Scheduled pre-NDA meeting with FDA in early December to align on data package format and requirements for NDA submission in early 2026.
- Successful GMP inspection by Israeli Ministry of Health, marking fourth consecutive successful inspection and readiness for European market.
- Completed U.S. market access study showing 80% likelihood of hospitals adding D-PLEX100 to formulary and 60% expected utilization rate among surgeons.
- Advanced discussions with U.S. partners leveraging Fast Track and Breakthrough Therapy designations.

**【CFO Financial Commentary】**
- R&D expenses decreased to $5.3M (down from $6.2M Q2 2025) due to Phase III trial completion.
- Net loss improved to $7.5M for Q3, with $18.8M cash balance supporting operations into 2026.
- Debt reduced to $2.4M from $6.5M, reflecting financial discipline.

**【Q&A Highlights】**
- CEO expresses confidence in FDA inspection readiness, citing experienced team and ongoing GMP compliance efforts.
- Potential premium pricing if NTAP designation secured, driven by strong surgeon and hospital interest.
- Exploration of U.S. manufacturing expansion to meet demand and align with local production trends.

PolyPid Ltd. (PYPD) Q3 2025 Earnings Call Transcript

Revenue

Sales and Services Revenue

Financing Services Revenue

Other Revenue

Cost of Revenue

Cost of Goods and Services

Cost of Financing Services

Other Cost

Gross Profit

Other Operating Income

Operating Expenses

Selling, General and Administrative Expenses

Selling and Marketing Expenses

General and Administrative Expenses

Research and Development Expenses

Loss on Bad Debts

Loss on Impairment of Other Assets

Loss on Disposal of Assets

Other Operating Expenses

Operating Income

Non-Operating Income (Loss)

Income (Loss) from Affiliates

Income (Loss) from Associates

Income (Loss) from Joint ventures

Gain (Loss) on Other Investment

Gain (Loss) on Change in Fair Value

Gain (Loss) on Foreign Currency Exchange

Other Non-Operating Income (Loss)

Net Interest Expense

Interest Expense

Interest Income

Pretax Income From Continuing Operations

Income Tax Expense

Current Income Tax

Deferred Income Tax

Income Tax Adjustments

Net Income from Continuing Operations

Income from Discontinued Operations

Other Items Before Net Income

Net Income

Net Income Attributable to Minority Interests

Net Income Attributable to Owners of the Company

Preferred Stock Dividends

Other Adjustments

Net Income Attributable to Common Stockholders

Other Comprehensive Income

Total Comprehensive Income

Total Comprehensive Income Attributable to Minority Interests

Total Comprehensive Income Attributable to Owners of the Company

Basic EPS

Basic EPS from Continuing Operations

Basic EPS from Discontinued Operations

Diluted EPS

Diluted EPS from Continuing Operations

Diluted EPS from Discontinued Operations

PYPD

PYPD fundamentals

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