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Fulcrum Therapeutics (FULC)
NASDAQ:FULC
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Fulcrum Therapeutics
(NASDAQ:FULC)
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Rating:49Neutral
Price Target:
$8.50
▼(-5.35% Downside)
Action:ReiteratedDate:02/25/26
The score is held down primarily by weak financial performance (persistent losses and renewed 2025 cash burn) and bearish technicals (price below key moving averages with negative momentum). These are partially offset by a more positive earnings-call backdrop driven by encouraging early clinical signals and a defined regulatory path, while valuation support is limited due to a negative P/E and no dividend yield.
Positive Factors
Robust pharmacodynamic efficacy
Sustained, large HbF induction and doubled F‑cell percentages at 12 weeks are durable mechanistic signals supporting a disease-modifying profile. Such clear PD effects increase the probability that registrational endpoints can be met or accepted as surrogates, strengthening long-term clinical and commercial prospects.
Defined regulatory development path
A scheduled FDA end‑of‑Phase meeting and planned registration-enabling study narrow development uncertainty. Clear regulator engagement and timelines improve predictability of the program, reduce structural execution risk, and expedite potential label advancement if larger trials confirm PD and clinical benefit.
Relative balance sheet strength and fresh capital
Low leverage and a sizable equity base combined with a recent $175M offering materially extend runway versus peers, lowering immediate financing pressure. This provides durable funding capacity to advance registrational activities and de-risks near-term development financing needs.
Negative Factors
Worsening cash burn
Material negative operating and free cash flow in 2025 marks a structural cash consumption trend that increases reliance on external financing. Persistent burn reduces flexibility, raises dilution risk for shareholders, and can constrain the pace or scale of clinical programs absent further capital.
Chronic unprofitability
Repeated annual losses and sharp 2025 deterioration indicate the company remains far from commercial self-sufficiency. Continued negative returns and zero 2025 revenue mean value creation hinges entirely on successful late‑stage development and approvals, concentrating execution risk for investors.
Limited clinical generalizability and durability data
Early data derive from a tiny, short-duration cohort and are underpowered for clinical endpoints like VOCs; assay gaps and response heterogeneity raise uncertainty about long-term durability, label population size, and real-world effectiveness, extending risk into registrational trials and commercial adoption.
Fulcrum Therapeutics (FULC) vs. SPDR S&P 500 ETF (SPY)
Market Cap
$566.03M
Dividend YieldN/A
Average Volume (3M)747.01K
Price to Earnings (P/E)―
Beta (1Y)0.87
Revenue Growth-100.00%
EPS Growth-305.92%
CountryUS
Employees45
SectorHealthcare
Sector Strength45
IndustryBiotechnology
Share Statistics
EPS (TTM)-0.31
Shares Outstanding66,600,210
10 Day Avg. Volume1,037,893
30 Day Avg. Volume747,009
Financial Highlights & Ratios
PEG Ratio-0.02
Price to Book (P/B)2.05
Price to Sales (P/S)0.00
P/FCF Ratio-11.87
Enterprise Value/Market Cap0.52
Enterprise Value/RevenueN/A
Enterprise Value/Gross ProfitN/A
Enterprise Value/Ebitda-3.87
Forecast
1Y Price Target
$16.89Price Target Upside88.08% Upside
Rating ConsensusModerate Buy
Number of Analyst Covering10
EPS Forecast (FY)-1.21
Revenue Forecast (FY)N/A
Fulcrum Therapeutics Business Overview & Revenue Model
Company DescriptionFulcrum Therapeutics, Inc., a clinical-stage biopharmaceutical company, focuses on developing products for improving the lives of patients with genetically defined diseases in the areas of high unmet medical need in the United States. Its product candidates are losmapimod, a small molecule for the treatment of facioscapulohumeral muscular dystrophy; and FTX-6058, an investigational oral fetal hemoglobin inducer for the treatment of sickle cell disease and other hemoglobinopathies, including beta-thalassemia. The company is also discovering drug targets for the treatments of rare neuromuscular, muscular, central nervous system, and hematologic disorders, as well as cardiomyopathies and pulmonary diseases. Fulcrum Therapeutics, Inc. has research and discovery collaboration agreement with Acceleron Pharma Inc. to identify biological targets to modulate specific pathways associated with a targeted indication within the pulmonary disease space; and has a strategic collaboration and license agreement with MyoKardia, Inc. to discover, develop, and commercialize novel targeted therapies for the treatment of genetic cardiomyopathies. Fulcrum Therapeutics, Inc. was Incorporated in 2015 and is headquartered in Cambridge, Massachusetts.
How the Company Makes MoneyFulcrum Therapeutics generates revenue primarily through the development and commercialization of its therapeutic candidates. The company may earn money through several key revenue streams, including partnerships and collaborations with larger pharmaceutical companies, milestone payments upon reaching specific development and regulatory achievements, and royalties from future sales of any marketed products. Additionally, Fulcrum may receive funding through grants or research grants that support its development programs, further contributing to its financial sustainability.
Fulcrum Therapeutics Earnings Call Summary
Earnings Call Date:Feb 24, 2026
(Q4-2025)
| % Change Since: |
Next Earnings Date:Apr 30, 2026
Earnings Call Sentiment Positive
The call presented a strong set of early biologic and hematologic signals at the 20 mg dose — substantial HbF induction (+12.2% absolute), doubled F-cell percentages, marked reductions in hemolysis markers (LDH -34%, indirect bilirubin -40%), reticulocyte decline (-42%), and a ~1.1 g/dL hemoglobin increase — alongside an acceptable short-term safety profile and a clear regulatory path forward. Major caveats are small sample size, short duration (12 weeks), assay missingness/variability, and that clinical endpoints (VOCs, long-term durability, broader safety) remain exploratory and unproven. On balance the data are encouraging and support advancing to a potential registration-enabling study, while recognizing the need for larger, longer trials to confirm clinical benefit and durability.Q4-2025 Updates
Positive Updates
Comparative Potential vs. Standard of Care
Pociredir 20 mg HbF and F-cell levels at 12 weeks (~20% HbF, ~60% F cells) are comparable to the highest quartile responders to hydroxyurea (which averaged ~10% HbF and ~35% F cells overall), suggesting potential to be a best-in-class oral HbF inducer.
Robust HbF Induction at 20 mg
Mean fetal hemoglobin (HbF) increased from 7.1% baseline to 19.3% at week 12 (absolute delta +12.2%), with 7 of 12 patients (58%) achieving ≥20% HbF — a threshold historically linked to clinical protection.
Progression Toward Pancellularity
F-cell percentage approximately doubled from ~31% to 63% at week 12, indicating broader distribution of HbF across red cells and potential for increased cellular protection over time.
Marked Improvements in Hemolysis Biomarkers
LDH fell ~34% and indirect bilirubin fell ~40% at week 12, consistent with reduced hemolysis following HbF induction.
Improvement in Erythropoiesis and Hemoglobin
Reticulocytes decreased by ~42% (less bone marrow stress) and mean total hemoglobin rose by ~1.1 g/dL at 20 mg after 12 weeks (compared with ~0.9 g/dL at 12 mg).
Encouraging VOC Trend in Short-Term Data
Based on baseline rates the cohort would have been expected to experience ~16 VOCs over 12 weeks; during the treatment period the PD analysis subset observed 6 VOCs in 5 patients and 7 of 12 patients reported no VOCs during treatment, an encouraging early signal (study not powered for VOCs).
Generally Well Tolerated Safety Profile
No treatment-related serious adverse events reported at 20 mg, three treatment-related adverse events resolved with continued dosing, and no treatment-related discontinuations; pociredir has now been dosed in ~150 adults to date.
Dose Selection and Pharmacodynamic Rationale
Pharmacodynamic data (HBG mRNA induction) showed dose-responsive effects up to 20 mg but not from 20→30 mg in earlier studies, supporting 20 mg as the dose to take forward into regulatory discussions.
Regulatory and Development Progress
Planned FDA end-of-Phase meeting (minutes expected Q2 2026), intent to initiate a potential registration-enabling trial in H2 2026, EMA protocol assistance engagement mid-2026, and activation of an open-label extension to assess longer-term safety/durability.
Negative Updates
Small Sample Size and Short Follow-Up
Data are from a small cohort (13 enrolled, 12 evaluable for PD) with only 12 weeks of treatment — limits statistical power, especially for clinical endpoints like VOC reduction and durability assessment.
Not Powered for VOCs and Limited VOC Adjudication
Vaso-occlusive crisis (VOC) observations are exploratory only: expected 16 events vs observed 6 during treatment (PD set) but VOCs were not adjudicated and the study was not designed or powered to demonstrate clinical VOC reduction.
Missing / Variable Assay Data Affected Some Timepoints
Not all patients had samples at every timepoint (two patients missing at week 12 contributed to an apparent dip in F-cell percent), and assay variability produced isolated anomalies (e.g., one patient with earlier higher HbF then lower at week 12).
Heterogeneous Genetic Response Risk (Haplotype Effects)
Response heterogeneity by sickle haplotype (e.g., CAR haplotype associated with lower response) was observed historically and remains a potential source of variable efficacy across populations; cohort composition (regional differences) affects representativeness.
Serious Incident Unrelated to Drug and Safety Follow-Up Events
One enrolled individual died on day 1 (deemed unrelated to study drug) and the broader safety dataset included VOCs in the safety analysis set (10 VOCs reported there), underscoring severity of treated population and need for continued safety monitoring.
Generalizability / Enrollment Constraints
Current inclusion/exclusion criteria represent a subset of the global SCD population; company estimates ~20% of patients meet the present entry criteria, which could limit immediate label population and commercial penetration unless criteria are broadened.
Short-Term Data Leave Durability and Long-Term Safety Open
Durability of HbF response, longer-term pancellularity progression, and chronic safety signals remain unproven and require extension study and registrational trials to confirm.
Competitive and Regulatory Uncertainties
Other HbF-inducing approaches (e.g., molecular glue/WIZ degraders) are in development; while Fulcrum estimates a ~2-year head start, competitors and regulatory acceptance of HbF as a surrogate/accelerated endpoint remain uncertain.
Company Guidance
Guidance from the call centered on advancing the 20 mg dose into regulatory discussions and a potential registration-enabling study: the 20 mg cohort (data cutoff 12/23/2025; 13 enrolled, 12 PD-evaluable) will be the dose taken to the FDA, with an FDA follow-up/update on next trial design in Q2 2026 and planned initiation of a registration-enabling trial in H2 2026 pending FDA feedback; the company will seek EMA protocol assistance mid‑2026 and is activating sites for an open‑label extension. Key metrics supporting that path included a mean HbF rise from 7.1% baseline to 19.3% at week 12 (Δ12.2%), 7/12 patients (58%) ≥20% HbF, F‑cells doubling from ~31% to ~63%, LDH down 34%, indirect bilirubin down 40%, reticulocytes down 42%, RDW normalizing, and a mean total hemoglobin increase of ~1.1 g/dL at week 12 (versus 0.9 g/dL at 12 mg); VOCs were fewer than expected (16 expected vs 6 observed during treatment in the PD set; 9 total including safety follow‑up), safety showed no treatment‑related SAEs, three treatment‑related AEs that resolved with continued dosing, no treatment‑related discontinuations, and pociredir has been dosed in ~150 adults to date.Fulcrum Therapeutics Financial Statement Overview
Summary
Operating fundamentals are weak: recurring net losses (with a sharp 2025 deterioration as revenue fell to zero) and sustained negative operating/free cash flow with burn worsening in 2025. The balance sheet is a relative positive with very low leverage and sizable equity, but continued losses imply ongoing funding/dilution risk.Income Statement
Profitability is weak and volatile: the company reported net losses every year shown (2020–2025), with a sharp deterioration in 2025 as revenue fell to zero and losses widened (net loss of ~$74.9M vs. ~$9.7M in 2024). While 2024 showed a meaningful revenue step-up (to ~$80.0M from ~$2.8M in 2023), the business remains deeply unprofitable overall, reflecting ongoing R&D and operating spend typical for biotechnology companies.18
Very Negative
Balance Sheet
The balance sheet is a relative strength: leverage is very low (debt-to-equity ~1.8% in 2025; generally low across periods), supported by a sizable equity base (~$349.0M in 2025). However, persistent losses translate into consistently negative returns on equity (notably -21% in 2025), signaling ongoing value dilution risk if losses continue and additional capital is required.72
Positive
Cash Flow
Cash generation is weak with sustained cash burn: operating cash flow and free cash flow are negative across all years shown, with 2025 operating cash flow of about -$60.1M and free cash flow of about -$60.4M, worsening versus 2024 (near breakeven burn at roughly -$2–3M). While cash burn improved materially in 2024 versus 2023, the reversal in 2025 increases funding risk and heightens dependence on external financing.22
Negative
| Breakdown | Dec 2025 | Dec 2024 | Dec 2023 | Dec 2022 | Dec 2021 |
|---|---|---|---|---|---|
Income Statement | |||||
| Total Revenue | 0.00 | 80.00M | 2.81M | 6.34M | 19.16M |
| Gross Profit | -1.39M | 78.41M | 2.81M | -70.44M | -50.54M |
| EBITDA | -73.49M | -18.24M | -108.49M | -109.72M | -78.54M |
| Net Income | -74.88M | -9.72M | -97.33M | -109.87M | -80.85M |
Balance Sheet | |||||
| Total Assets | 366.28M | 260.72M | 257.69M | 226.69M | 235.00M |
| Cash, Cash Equivalents and Short-Term Investments | 352.31M | 241.02M | 236.22M | 202.92M | 218.16M |
| Total Debt | 6.44M | 8.63M | 10.82M | 13.42M | 0.00 |
| Total Liabilities | 17.28M | 17.68M | 22.50M | 27.74M | 23.46M |
| Stockholders Equity | 349.00M | 243.03M | 235.19M | 198.94M | 211.54M |
Cash Flow | |||||
| Free Cash Flow | -60.38M | -2.50M | -91.47M | -99.01M | -80.19M |
| Operating Cash Flow | -60.06M | -2.22M | -90.97M | -97.05M | -78.48M |
| Investing Cash Flow | 30.72M | 32.23M | -36.69M | 12.41M | -129.67M |
| Financing Cash Flow | 168.67M | 2.75M | 118.12M | 84.32M | 186.51M |
Fulcrum Therapeutics Technical Analysis
Negative
8.98
Price Trends
10.86
Negative
10.27
Negative
8.67
Positive
Market Momentum
-0.20
Positive
38.05
Neutral
20.94
Neutral
Evaluating momentum and price trends is crucial in stock analysis to make informed investment decisions. For FULC, the sentiment is Negative. The current price of 8.98 is below the 20-day moving average (MA) of 10.41, below the 50-day MA of 10.86, and above the 200-day MA of 8.67, indicating a neutral trend. The MACD of -0.20 indicates Positive momentum. The RSI at 38.05 is Neutral, neither overbought nor oversold. The STOCH value of 20.94 is Neutral, not indicating any strong overbought or oversold conditions. Overall, these indicators collectively point to a Negative sentiment for FULC.
Fulcrum Therapeutics Risk Analysis
Fulcrum Therapeutics disclosed 70 risk factors in its most recent earnings report. Fulcrum Therapeutics reported the most risks in the "Tech & Innovation" category.
Finance & Corporate - Financial and accounting risks. Risks related to the execution of corporate activity and strategy
Latest Risks Added 0 New Risks
Fulcrum Therapeutics Peers Comparison
UnderperformOutperform
Sector (51)
Name | Overall Rating | Market Cap | P/E Ratio | ROE | Dividend Yield | Revenue Growth | EPS Growth |
|---|---|---|---|---|---|---|---|
75 Outperform | $1.46B | 59.23 | 9.28% | ― | 1112.27% | ― | |
53 Neutral | $385.05M | -16.17 | -26.54% | ― | ― | -73.48% | |
51 Neutral | $7.86B | -0.30 | -43.30% | 2.27% | 22.53% | -2.21% | |
49 Neutral | $566.03M | -7.60 | -25.30% | ― | -100.00% | -305.92% | |
49 Neutral | $1.16B | -7.84 | -144.07% | ― | ― | ― | |
48 Neutral | $543.82M | -2.95 | ― | ― | 6.35% | 39.57% |
* Healthcare Sector Average
FULC
Fulcrum Therapeutics
8.98
5.61
166.47%
MNPR
Monopar Therapeutics Inc
55.62
25.37
83.87%
ADCT
ADC Therapeutics
4.27
2.69
170.25%
GLUE
Monte Rosa Therapeutics
18.09
12.64
231.93%
INBX
Inhibrx Biosciences Inc
80.27
67.67
537.06%
Fulcrum Therapeutics Corporate Events
Business Operations and StrategyProduct-Related Announcements
Fulcrum Therapeutics updates strategy on lead sickle cell therapy
Positive
Jan 12, 2026
On January 12, 2026, Fulcrum Therapeutics updated its corporate presentation ahead of investor meetings and a scheduled appearance at the 44th Annual J.P. Morgan Healthcare Conference, detailing new business and strategic updates centered on its lead candidate pociredir for sickle cell disease and the financial resources backing its pipeline. The company highlighted initial data from the 20 mg cohort of its Phase 1b PIONEER trial as of November 11, 2025, showing robust, rapid, and pan-cellular increases in fetal hemoglobin with early signs of improvements in anemia, hemolysis and reductions in vaso-occlusive crises, while maintaining generally favorable tolerability at once-daily dosing; these results, combined with the continued high unmet need in sickle cell disease despite recent approvals and withdrawals in the space, position pociredir as a potential best-in-class, convenient oral therapy that could fill a significant treatment gap as Fulcrum targets an End-of-Phase meeting with regulators in the first half of 2026 and prepares its next study for initiation in the second half of 2026.
The most recent analyst rating on (FULC) stock is a Buy with a $20.00 price target. To see the full list of analyst forecasts on Fulcrum Therapeutics stock, see the FULC Stock Forecast page.
Business Operations and StrategyPrivate Placements and Financing
Fulcrum Therapeutics Announces $175 Million Public Offering
Positive
Dec 11, 2025
On December 10, 2025, Fulcrum Therapeutics announced the pricing of its underwritten public offering, which includes 11,851,853 shares of common stock and pre-funded warrants to purchase up to 1,111,193 shares, raising gross proceeds of $175 million. The offering is expected to close on December 11, 2025, and the net proceeds will be used for general corporate purposes, including working capital, research and development, and potential acquisitions, positioning Fulcrum to enhance its operations and market presence.
The most recent analyst rating on (FULC) stock is a Hold with a $16.00 price target. To see the full list of analyst forecasts on Fulcrum Therapeutics stock, see the FULC Stock Forecast page.
Product-Related Announcements
Fulcrum Therapeutics Reports Positive Phase 1b Trial Results
Positive
Dec 8, 2025
On December 6, 2025, Fulcrum Therapeutics announced positive initial results from the 20 mg dose cohort of the Phase 1b PIONEER trial of pociredir for sickle cell disease at the 67th American Society of Hematology Annual Meeting. The trial showed a significant increase in fetal hemoglobin levels, with 58% of patients achieving levels associated with reduced vaso-occlusive crises. Pociredir was well-tolerated with no serious adverse events, reinforcing its potential as a best-in-class treatment for sickle cell disease.
The most recent analyst rating on (FULC) stock is a Buy with a $23.00 price target. To see the full list of analyst forecasts on Fulcrum Therapeutics stock, see the FULC Stock Forecast page.
Glossary
BuyA stock rated as a "Buy" is expected to perform better than the overall market or a specific benchmark over the near-to-medium term. This rating suggests the stock is likely to deliver higher returns compared to other stocks in the same sector or market index. Note: This is not investment advice; please consult a financial advisor before making investment decisions.
HoldA stock rated as a "Hold" is expected to perform in line with the overall market or a specific benchmark. This rating indicates that the stock is neither particularly compelling nor unfavorable for investment. Note: This is not investment advice; please consult a financial advisor before making investment decisions.
SellA stock rated as a "Sell" is expected to perform worse than the overall market or a specific benchmark over the near-to-medium term. This rating suggests the stock may deliver lower returns compared to other stocks in the same sector or market index. Note: This is not investment advice; please consult a financial advisor before making investment decisions.
Disclaimer
This AI Analyst Stock Report is automatically generated by our AI systems using advanced algorithms and publicly available financial, technical, and market data. While the information provided aims to be accurate and insightful, it is intended for informational purposes only and should not be considered financial advice. Any content created by an AI (Artificial Intelligence) system may contain inaccuracies and/or contain errors. Investing in stocks carries inherent risks, and past performance is not indicative of future results. This report does not account for your personal financial circumstances, objectives, or risk tolerance. Always conduct your own research or consult with a qualified financial advisor before making investment decisions. The analysis and recommendations provided are based on historical and current data and may not fully reflect future market conditions or unexpected developments. Neither the creators of this report nor its affiliated entities guarantee the accuracy, completeness, or reliability of the information presented. Use this report at your own discretion and risk.