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- **Pipeline Expansion**: Qtorin Rapamycin advancing in 3 Phase II/III studies; Qtorin Pitavastatin entering clinic for DSAP.
- **Financial Strength**: $63.6M cash runway through Q2 2027; disciplined cost control supporting rare disease focus.
- **Regulatory Strategy**: sNDA pathway to expand indications post-MLM approval; Phase III SELVA study on track for Q1 2026 readout.
- **Commercial Readiness**: Dual-source manufacturing partners; stability data ensures seamless transition to commercial supply.

**【CEO Summary Section】**
- Expanded rare disease pipeline with Qtorin Rapamycin targeting microcystic lymphatic malformations (MLM), cutaneous venous malformations (CVM), and clinically significant angiokeratomas.
- Announced Qtorin Pitavastatin for disseminated superficial actinic porokeratosis (DSAP), leveraging mevalonate pathway inhibition.
- Strategic focus on serial supplemental NDAs (sNDAs) to efficiently expand indications post-approval.
- Phase III SELVA study for MLM on track for Q1 2026 readout with Breakthrough Therapy and Fast Track designations.

**【CFO Financial Commentary】**
- Cash balance of $63.6M as of Q3 2025, supporting ~1.5 years of runway through Q2 2027.
- Total operating expenses $10.2M, aligned with clinical trial and commercial readiness activities.
- Financial strategy emphasizes capital efficiency and risk mitigation through multi-source manufacturing.

**【Q&A Key Highlights】**
- **FDA Interactions**: Stable collaboration with FDA Dermatology Division; orphan drug grant funding renewed for Phase III SELVA study.
- **Trial Design**: Phase II CVM study uses single-arm baseline-controlled design; Phase III MLM endpoints include static/dynamic scales and patient-reported outcomes.
- **Commercial Strategy**: sNDA strategy for new indications (angiokeratomas, DSAP) to leverage existing safety/tolerability data.
- **Manufacturing**: Dual-source commercial manufacturing partners with strong FDA track records; stability data extends beyond NDA submission.
- **Competitive Position**: No FDA-approved therapies for target indications; Qtorin platform's tissue-specific delivery addresses unmet need for durable, non-invasive treatments.

Palvella Therapeutics Inc (PVLA) 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

PVLA

PVLA fundamentals

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