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- **Phase III Trial Acceleration**: CD388 Phase III ANCHOR trial initiated six months early, with 6,000 participants (50% enrolled) across 150 sites.
- **FDA Recognition**: Breakthrough Therapy Designation and Fast Track Status enhance regulatory engagement.
- **BARDA Funding**: $339M to support U.S. manufacturing and expanded clinical development, including pandemic preparedness studies.
- **Market Potential**: Addressable population expanded to >100M in the U.S., with 76.1% efficacy demonstrated in Phase IIb.
- **Manufacturing Readiness**: Initial 5M doses/year production capacity with WuXi, U.S. scale-up via BARDA, and global partners for long-term supply.
- **Pandemic Preparedness**: Preclinical data shows efficacy against H5N1 and neuraminidase-resistant strains, positioning for government stockpiling discussions.

**【CEO Summary Section】**
- CD388 entered Phase III ANCHOR trial six months ahead of schedule, with 6,000 participants across 150 sites, over 50% enrolled as of late September 2025.
- FDA granted Breakthrough Therapy Designation, enabling enhanced regulatory engagement and potential accelerated approval.
- Secured $339M BARDA funding for U.S.-based manufacturing and expanded clinical development, including $58M base period and up to $281M in options.
- Received $45M milestone payment from J&J, booked in Q3 but payable in Q4.
- Cash position of $476M as of September 30, fully funding Phase III through all scenarios.

**【Clinical Trial Updates】**
- ANCHOR trial expanded to include healthy adults ≥65, increasing addressable population from 50M to >100M in the U.S.
- Primary endpoint: laboratory-confirmed influenza with fever and respiratory symptoms.
- Interim analysis in Q1 2026 will assess event rates and determine need for Southern Hemisphere enrollment.
- Phase IIb NAVIGATE study showed 76.1% efficacy with 450mg dose, sustained protection through flu season.

**【Manufacturing and Supply Chain】**
- WuXi Biologics to produce initial 5M doses/year, with U.S. manufacturing scale-up via BARDA funding.
- BARDA supports tech transfer for higher concentration formulation and alternative presentations.
- Global partners being evaluated for long-term capacity expansion.

**【Q&A Key Highlights】**
- Enrollment progressing faster than expected, with no early flu activity detected in North America.
- Independent statistician will盲行 interim analysis without sharing efficacy data with Cidara.
- Market research shows strong physician interest in CD388 for both high-risk and mild comorbidity populations.
- Preclinical studies demonstrate CD388 efficacy against H5N1 and neuraminidase-resistant strains, with potential for pandemic stockpiling discussions.


Cidara Therapeutics, Inc. (CDTX) 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

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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

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Diluted EPS from Discontinued Operations

CDTX

CDTX fundamentals

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