What is Fulcrum Therapeutics's gross profit margin?

What is the market's earnings forecast for Fulcrum Therapeutics next quarter?

What guidance did Fulcrum Therapeutics's management provide for the next earnings period?

What were the key takeaways from Fulcrum Therapeutics's earnings call?

What is Fulcrum Therapeutics's latest dividend and current dividend yield?

What were the key takeaways from Fulcrum Therapeutics’s earnings call?

What does Fulcrum Therapeutics do and what are its main business segments?

What factors drove the changes in Fulcrum Therapeutics's revenue and profit?

- **Pociredir shows promising SCD data**: 12mg cohort achieved 15.7% HbF induction, 50% VOC reduction, and all Grade 1 AEs. 20mg cohort enrollment complete, with ASH 2025 data expected.
- **Open-label extension launched**: Addresses patient demand for continued treatment post-PIONEER.
- **Strong financial position**: $200.6M cash runway supports operations into 2028.
- **Market potential**: 20,000 U.S. SCD patients meet inclusion criteria, with global addressable market of 7.7M.
- **Regulatory momentum**: End-of-Phase I meeting with FDA planned for Q1 2026.

**【CEO Summary Section】**
- Presented progress on lead program **pociredir** for sickle cell disease (SCD), highlighting Phase Ib PIONEER trial results:
  - **12mg cohort**: Achieved target product profile with 15.7% HbF induction, 1.0g/dL increase in total hemoglobin, and 50% reduction in vaso-occlusive crises (VOCs). All adverse events (AEs) were Grade 1 and resolved without disruption.
  - **20mg cohort**: Enrollment completed with 12 patients, 60% from U.S. and 40% from Nigeria. Data from ~50% of patients (Day 84) and full cohort (Day 42) to be presented at ASH 2025. Baseline HbF: 7.1% mean, 7.3% median.
- Launched **open-label extension (OLE)** study to evaluate long-term safety and efficacy post-PIONEER.
- Expanded pipeline includes programs for bone marrow failure syndromes (e.g., Diamond Blackfan anemia) and preclinical work on FTX-6274 for prostate cancer.

**【CFO Financial Commentary】**
- Q3 2025 financials:
  - Total revenue: $0 (no product sales).
  - R&D expenses: $14.3M (down 2% vs. Q3 2024, driven by workforce reduction and discontinuation of losmapimod).
  - G&A expenses: $7.6M (down 9% vs. Q3 2024, due to reduced professional services).
  - Net loss: $19.6M (vs. $21.7M in Q3 2024).
  - Cash balance: $200.6M (sufficient for operations into 2028).

**【Q&A Key Highlights】**
- **Dose response**: 20mg expected to outperform 12mg based on healthy volunteer data (14-day HBG mRNA fold induction). ASH 2025 presentation will include Day 84 data for ~50% of 20mg cohort and full Day 42 data for all 12 patients.
- **Market opportunity**: ~20% of U.S. SCD population (20,000 patients) meets PIONEER inclusion criteria (≥2 VOCs in 6 months, not on hydroxyurea). Global addressable market: 7.7M SCD patients worldwide.
- **Regulatory path**: End-of-Phase I meeting with FDA planned for Q1 2026 to discuss Phase II design. Potential for accelerated approval based on HbF induction.
- **Competitive landscape**: Oxbryta withdrawal leaves unmet need; pociredir's once-daily oral formulation and safety profile differentiate it from cell/gene therapies.
- **Cash runway**: Current funds support Phase II development and pipeline expansion into 2028.

Fulcrum Therapeutics, Inc. (FULC) 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

FULC

FULC fundamentals

You can ask Aime