Celcuity Inc.
- Open
- 105.78
- Day high
- 106.92
- Day low
- 102.80
- Prev close
- 104.62
- Volume
- 519K
- Mkt cap
- $5.0B
- P/E (TTM)
- —
- EPS (TTM)
- —
- P/B
- 93.7
- P/S
- —
- Yield
- —
- Per share
- —
- ▼Insiders net selling -$4.8M over the last 3 months (0 open-market buys, 7 sales)
- 🏛Institutions accumulating (13F)
Celcuity Inc. (CELC) is a Healthcare company listed on NASDAQ. The stock is up 738% over the past year. Over the trailing 3 months, insiders filed 0 open-market buys and 7 sales (SEC Form 4).
Celcuity Inc. (CELC) financials & analyst ratings
Fundamentals (TTM)
Analyst consensus · 6 analysts
Source: exchange market data + company filings. Figures are trailing-twelve-month or as most recently reported. For informational purposes only — not investment advice.
CELC earnings date, history & EPS estimates
| Report date | EPS est | EPS actual | Surprise | Revenue | Rev. surprise |
|---|---|---|---|---|---|
| May 14, 2026 | $-1.07 | $-0.97 | +9.3% | — | — |
| Mar 25, 2026 | $-1.06 | $-0.97 | +8.5% | — | — |
| Nov 12, 2025 | $-1.02 | $-0.92 | +9.8% | — | — |
| Aug 14, 2025 | $-0.90 | $-1.04 | -15.6% | — | — |
| May 14, 2025 | $-0.95 | $-0.86 | +9.5% | — | — |
| Mar 31, 2025 | $-0.72 | $-0.85 | -18.1% | $121344 | — |
| Nov 14, 2024 | $-0.65 | $-0.70 | -7.7% | — | — |
| Aug 14, 2024 | $-0.71 | $-0.62 | +12.7% | — | — |
| May 15, 2024 | $-0.71 | $-0.64 | +9.9% | — | — |
| Nov 13, 2023 | $-0.74 | $-0.83 | -12.2% | — | — |
| Aug 10, 2023 | $-0.67 | $-0.66 | +1.5% | — | — |
| May 15, 2023 | $-0.65 | $-0.55 | +15.4% | — | — |
CELC insider trading activity (SEC Form 4)
| Date | Insider | Type | Shares | Price |
|---|---|---|---|---|
| Jun 9, 2026 | ROMP CHARLES Rdirector | Grant | 1,530 | — |
| Jun 9, 2026 | Furcht Leodirector | Grant | 1,530 | — |
| Jun 9, 2026 | Buller Richard Edirector | Grant | 1,530 | — |
| Jun 9, 2026 | NIGON RICHARDdirector | Grant | 1,530 | — |
| Jun 9, 2026 | Murphy Polly A.director | Grant | 1,530 | — |
| Jun 9, 2026 | Dalvey Daviddirector | Grant | 1,530 | — |
| Jun 4, 2026 | Laing Lance G.director, officer: Chief Science Officer | Option | 1,000 | $9.89 |
| May 6, 2026 | Buller Richard Edirector | Sell | 2,825 | $142.04 |
| May 6, 2026 | Buller Richard Edirector | Sell | 365 | $143.24 |
| May 6, 2026 | Dalvey Daviddirector | Sell | 25,000 | $140.68 |
| May 6, 2026 | Buller Richard Edirector | Option | 9,000 | $5.10 |
| May 6, 2026 | Buller Richard Edirector | Sell | 1,289 | $137.00 |
| May 6, 2026 | Buller Richard Edirector | Sell | 550 | $139.00 |
| May 6, 2026 | Buller Richard Edirector | Sell | 1,670 | $139.58 |
| May 6, 2026 | Buller Richard Edirector | Sell | 2,301 | $141.03 |
Source: CELC SEC Form 4 filings, latest Jun 9, 2026. For informational purposes only — not investment advice.
See the full CELC insider & 13F page →Celcuity Inc. company profile
Overview
Celcuity Inc. (NASDAQ:CELC) is a clinical-stage biotechnology company founded in 2011 and headquartered in Minneapolis, Minnesota. The company went public in September 2017 and focuses on developing molecularly targeted cancer therapies. Celcuity operates through two main platforms: its lead drug candidate gedatolisib, which targets multiple cancer pathways simultaneously, and its proprietary CELsignia diagnostic platform that uses living tumor cells to identify specific cellular processes driving individual patients' cancers. The company is currently in late-stage clinical trials with potential regulatory approval on the horizon for 2025-2026.
Business
Celcuity operates in the precision oncology sector of biotechnology, developing both therapeutic drugs and companion diagnostics for cancer treatment. The company addresses a fundamental challenge in cancer care: identifying which patients will respond to specific targeted therapies. The company's core offering centers around gedatolisib, a dual PI3K/mTOR inhibitor that simultaneously blocks three critical cancer cell survival pathways - PI3K, AKT, and mTOR (collectively called the PAM pathway). Unlike existing single-pathway inhibitors, gedatolisib's comprehensive approach aims to prevent cancer cells from developing resistance mechanisms. The drug is administered intravenously and is currently being tested primarily in hormone receptor-positive, HER2-negative advanced or metastatic breast cancer patients. Complementing the therapeutic approach is Celcuity's CELsignia diagnostic platform, which uses patients' living tumor cells to measure the activity of specific cellular signaling pathways. This technology helps identify which patients are most likely to benefit from particular targeted therapies. The platform includes tests like CELsignia MP, which measures HER2, c-Met, and PI3K signaling activity in breast and ovarian tumor cells. The company's business is currently focused entirely on clinical development, with no commercial revenue. All resources are directed toward advancing gedatolisib through Phase 3 clinical trials and developing the diagnostic platform to support precision medicine approaches in oncology.
Revenue model
Celcuity currently generates no revenue as it remains in the clinical development stage. The company's future business model will center on product sales of gedatolisib once approved, with potential additional revenue from licensing its diagnostic platform technology. The primary revenue opportunity lies in gedatolisib sales to hospitals and cancer treatment centers, with management estimating a potential peak revenue of over $2 billion for the second-line breast cancer indication alone. The addressable market includes approximately 200,000 late-stage cancer patients annually. Pricing will likely follow typical oncology drug models, with high per-treatment costs justified by clinical efficacy and the specialized nature of targeted cancer therapy. The company has a licensing agreement with Pfizer for gedatolisib development and commercialization rights, which will impact future revenue sharing arrangements. Additional revenue streams may include diagnostic test sales and potential expansion into other cancer types including prostate and gynecological cancers. Key factors that could increase margins include successful clinical trial outcomes leading to premium pricing, expanded indications beyond breast cancer, and potential combination therapy approvals. Margin pressures could arise from competitive therapies entering the market, manufacturing scale-up costs, extensive clinical trial requirements for additional indications, and the substantial commercial infrastructure needed for oncology drug launches. The intravenous administration route may provide reimbursement advantages compared to oral competitors, potentially supporting higher realized prices.
Risks & safety
Celcuity presents a mixed margin of safety profile typical of late-stage biotech companies, with strong liquidity but significant execution risk. **Liquidity and Solvency:** - Strong cash position of $205.7 million as of Q1 2025, providing runway through 2026 - Minimal debt with debt-to-equity ratio of 0.002 - Excellent current ratio of 6.61 and quick ratio of 6.61 - Operating cash burn of approximately $80+ million annually **Valuation Metrics:** - Trading at 5.0x price-to-book ratio, reflecting significant premium to tangible assets - Negative earnings and EBITDA due to clinical-stage status - Enterprise value reflects high expectations for clinical success **Key Risk Considerations:** - Binary risk profile dependent on Phase 3 trial outcomes expected in 2025 - No revenue generation with 100% dependence on clinical trial success - High cash burn rate requiring eventual additional financing or partnership - Single-asset concentration risk with limited pipeline diversification
Recent development
Over the past few years, Celcuity has made significant strategic progress transitioning from early-stage development to late-stage clinical trials. The company achieved a major milestone by receiving Breakthrough Therapy Designation from the FDA for gedatolisib, which expedites the regulatory review process. The company's primary focus has been advancing the VIKTORIA-1 Phase 3 trial, which completed enrollment of the PIK3CA wild-type patient cohort and is expected to deliver topline data in Q3 2025 for this group and Q4 2025 for the PIK3CA mutant cohort. This represents the company's most critical value inflection point. Celcuity has also expanded its clinical development with the VIKTORIA-2 Phase 3 trial targeting first-line treatment, which began dosing patients in Q2 2025. This trial addresses a potentially larger market opportunity worth an estimated additional $3 billion. The company has activated approximately 200 clinical sites globally to support enrollment. Strategic partnerships have expanded beyond the core breast cancer program. The company initiated a Phase 1b/2 trial in metastatic castration-resistant prostate cancer and began a collaboration with Dana Farber and Massachusetts General Hospital to evaluate gedatolisib in endometrial cancer, demonstrating efforts to broaden the therapeutic application. On the commercial preparation front, Celcuity hired Eldon Mayer as Chief Commercial Officer to build the infrastructure needed for potential drug launch. The company has also strengthened its balance sheet significantly, raising $129 million in equity and debt offerings to fund operations through the critical data readout period.
CELC company profile · for informational purposes only — not investment advice.
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