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- **NEPHRO Study**: Delays push completion to H1 2026; 2/6 new sites activated with similar enrollment rates.
- **FDA Process**: Conditional approval for compassionate use in specific patient populations.
- **Capital**: $21.3M cash, with sufficient funding through 2026.
- **Regulatory**: Breakthrough designation maintains efficient engagement.
- **Commercial Readiness**: Anticipated PMA approval in H2 2026.

**【CEO & Clinical Study Updates】**
- The company has completed the first closing of $17M financing, including $5M strategic investment from CorMedix and $12M institutional investors. 
- NEPHRO study enrollment delayed to H1 2026 due to site activation delays, with 2 of 6 new sites activated, and remaining 4 under process.
- FDA approved compassionate use IDE submission for specific CRRT patients.
- Anticipated PMA approval in late 2026, with sufficient capital through 2026.

**【CFO Financial Update】**
- Cash balance $21.3M as of Q3 2025, with reduced operating expenses to $14-15M for 2025.
- Conditional tranches contingent on regulatory approvals and stock price thresholds.

**【Q&A Highlights】**
- New target sites demonstrate similar enrollment rates to existing sites, no material impact.
- VA site delays due to personnel cuts, but not impacting current operations.

**【Risk Mitigation】**
- FDA breakthrough designation, efficient regulatory engagement, and nafamostat's 30+ year safety profile.

Key enrollment site activation timelines and commercial readiness.

Talphera, Inc. (TLPH) 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

TLPH

TLPH fundamentals

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