Fulcrum Therapeutics, Inc. FULC
We are a clinical-stage biopharmaceutical company focused on developing small molecules to improve the lives of patients with genetically defined rare diseases in areas of high unmet medical need.
Our lead product candidate, pociredir, is an oral small molecule designed to induce fetal hemoglobin, or HbF, and is in clinical development for the treatment of sickle cell disease, or SCD. We completed dosing in the PIONEER trial, a Phase 1b clinical trial evaluating pociredir in adults with SCD. The PIONEER trial included 12 mg and 20 mg once-daily dose cohorts, and evaluated subjects over a 12-week treatment period. We have reported clinical data demonstrating clinically relevant HbF induction, including progression toward pan-cellular distribution, and improvements in markers of hemolysis and anemia. We are currently activating sites in an open-label extension trial to evaluate longer-term safety and pharmacodynamic, or PD, durability in patients who completed the PIONEER trial. We plan to provide details regarding the design of the next trial in the second quarter of 2026 following receipt of meeting minutes from our End-of-Phase meeting with the FDA. Pending feedback from the FDA, we plan to initiate a potential registration-enabling trial in the second half of 2026.
Valuation FY2025 figures against the last close
Annual financial statements
Income statement
| Fiscal year | FY2025 | FY2024 | FY2023 | FY2022 | FY2021 | FY2020 | FY2019 | FY2018 | FY2017 |
|---|---|---|---|---|---|---|---|---|---|
| Revenue | $0 | $80.0M | $2.8M | $6.3M | $19.2M | $8.8M | — | — | — |
| R&D | $56.1M | $63.4M | $71.8M | $76.8M | $69.7M | $59.0M | $71.1M | $25.2M | — |
| SG&A | $28.7M | $36.4M | $41.7M | $41.7M | $30.5M | $21.4M | $13.1M | $8.3M | — |
| Total operating expenses | $84.8M | $101.9M | $113.5M | $118.9M | $100.2M | $80.4M | $84.2M | $33.5M | — |
| Operating income | -$84.8M | -$21.9M | -$110.7M | -$112.6M | -$81.1M | -$71.6M | -$84.2M | -$33.5M | — |
| Pre-tax income | -$74.9M | -$9.7M | — | — | — | — | — | — | — |
| Income tax | $0 | $0 | — | — | — | — | — | — | — |
| Net income | -$74.9M | -$9.7M | -$97.3M | -$109.9M | -$80.8M | -$70.8M | -$82.7M | -$32.6M | — |
| EPS, basic | -1.18 | -0.16 | -1.59 | -2.44 | -2.29 | -2.79 | — | — | — |
| EPS, diluted | -1.18 | -0.16 | -1.59 | -2.44 | -2.29 | -2.79 | -8.13 | -31.14 | — |
| Shares, diluted (wtd. avg.) | 63.4M | 62.0M | 61,310 | 44,991 | 35,361 | 25,354 | — | — | — |
Balance sheet
| Fiscal year | FY2025 | FY2024 | FY2023 | FY2022 | FY2021 | FY2020 | FY2019 | FY2018 | FY2017 |
|---|---|---|---|---|---|---|---|---|---|
| Cash and equivalents | $197.5M | $58.2M | $25.6M | $35.1M | $35.4M | $57.1M | $96.7M | $72.8M | — |
| Short-term investments | — | — | — | — | — | — | $0 | — | — |
| Total current assets | $357.5M | $249.9M | $242.2M | $207.5M | $226.0M | $119.5M | $100.1M | $74.1M | — |
| Property, plant and equipment | $2.8M | $3.9M | $5.2M | $6.9M | $7.4M | $8.4M | $9.2M | $10.5M | — |
| Total assets | $366.3M | $260.7M | $257.7M | $226.7M | $235.0M | $129.6M | $110.4M | $85.8M | — |
| Accounts payable | $1.6M | $1.2M | $2.8M | $3.6M | $4.8M | $4.1M | $2.2M | $1.3M | — |
| Total current liabilities | $13.0M | $11.0M | $13.7M | $16.7M | $19.2M | $26.7M | $12.1M | $4.2M | — |
| Total liabilities | $17.3M | $17.7M | $22.5M | $27.7M | $23.5M | $34.4M | $23.3M | $9.8M | — |
| Retained earnings | -$594.3M | -$519.4M | -$509.7M | -$412.3M | -$302.5M | -$221.6M | -$150.8M | -$68.1M | — |
| Total equity | $349.0M | $243.0M | $235.2M | $198.9M | $211.5M | $95.2M | $87.2M | -$63.7M | -$33.3M |
Cash flow
| Fiscal year | FY2025 | FY2024 | FY2023 | FY2022 | FY2021 | FY2020 | FY2019 | FY2018 | FY2017 |
|---|---|---|---|---|---|---|---|---|---|
| Operating cash flow | -$60.1M | -$2.2M | -$91.0M | -$97.0M | -$78.5M | -$53.7M | -$39.5M | -$22.6M | — |
| Depreciation and amortisation | $1.4M | $1.6M | $2.2M | $2.4M | $2.5M | $2.4M | $2.1M | $1.3M | — |
| Stock-based compensation | $12.5M | $14.6M | $14.8M | $13.3M | $11.1M | $7.3M | $4.2M | $2.2M | — |
| Capital expenditure | $314.0K | $278.0K | $508.0K | $2.0M | $1.7M | $1.3M | $853.0K | $9.0M | — |
| Investing cash flow | $30.7M | $32.2M | -$36.7M | $12.4M | -$129.7M | -$57.1M | -$944.0K | -$9.0M | — |
| Financing cash flow | $168.7M | $2.7M | $118.1M | $84.3M | $186.5M | $71.1M | $64.3M | $105.0M | — |
Figures as tagged in each year's own filing, in US dollars. A year restated by a later filing shows the restated figure. Capital expenditure, dividends and buybacks are cash out, shown positive. A line the filer does not report is not listed. Latest from accession 0001193125-26-379106.
Plot the figures US dollars
- Revenue
- Gross profit
- Net income
| Fiscal year | FY2017 | FY2018 | FY2019 | FY2020 | FY2021 | FY2022 | FY2023 | FY2024 | FY2025 |
|---|---|---|---|---|---|---|---|---|---|
| Revenue | — | — | — | $8.8M | $19.2M | $6.3M | $2.8M | $80.0M | $0 |
| Gross profit | — | — | — | — | — | — | — | — | — |
| Net income | — | -$32.6M | -$82.7M | -$70.8M | -$80.8M | -$109.9M | -$97.3M | -$9.7M | -$74.9M |
Recent filings and events
- Material agreement signed The company entered an agreement outside the ordinary course of business - a large contract, a credit facility, a merger agreement. Item 1.01
- Unregistered share sale Shares issued outside a registered offering. Dilution, and for a small company often the way it is funded. Item 3.02
- Change of control Control of the company has changed hands. Item 5.01
- Officer or director change Someone at the top arrived or left. The item covers everything from a board retirement to a chief executive being removed, and only the filing itself says which. Item 5.02
- Regulation FD disclosure Something the company told the market and had to tell everyone at once - usually a slide deck or a press release. Item 7.01
- Officer or director change Item 5.02
- Shareholder vote The results of the annual meeting or a special vote. Item 5.07
- Officer or director change Item 5.02
- Restructuring or exit costs A restructuring: layoffs, a plant closure, a business being wound down. Item 2.05
- Other event The catch-all. The company chose to disclose something that fits no other item, so the content is whatever it says it is. Item 8.01
- Other event Item 8.01
- Material agreement terminated An agreement that mattered has ended. Often the other half of a deal that fell through. Item 1.02
Item numbers are Form 8-K's own, and a filing date is up to four business days after the thing it reports. The same feed across the whole market.
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