📈 Price History

Ratio Health

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By Category

📊 Sector Averages

About

Celcuity Inc., a clinical-stage biotechnology company, focuses on the development of targeted therapies for the treatment of various solid tumors in the United States.

Key Ratios Snapshot

📈 Growth Pattern

⚡ Latest Quarter —

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📊 Quick Scorecard

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⭐ Superinvestors Holding CELC

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Manager	Shares	Value	% of Fund	Period
Steve Cohen Point72 Asset Management	280.3K	$32.0M	0.04%	Mar 2026

SEC Form 13F data. 45-day lag from quarter end.

🔍 Concall Decoded

🎙 Management Tone Tracker Confident Specific → Stable 4 quarters analysed

Q2 2025

Confident Specific

CEO uses phrases like 'unprecedented', 'profound implications', 'establish a new standard of care', and provides precise hazard ratios (0.24, 0.33) and median PFS improvements (7.3, 5.4 months). Language is assured and data-driven.

Q3 2025

Confident Specific

Management repeatedly emphasized the historic nature of the data, using phrases like 'set several new benchmarks', 'more favorable than have ever been reported', and '7.3-month incremental improvement'. They also provided detailed numerical targets, such as $5-6B addressable market and $2.5-3B peak revenue estimate, and outlined concrete commercial preparation steps.

Q4 2025

Confident Vague

Management uses strong language like 'unprecedented efficacy', 'transformative year', and 'optimistic' about FDA review, but repeatedly deflects questions on the mutant cohort data, saying 'we will not be answering questions' and providing no specifics on timing or expectations.

Q1 2026 latest

Confident Specific

Management used phrases like 'great progress,' 'pivotal moment,' 'groundbreaking data,' 'statistically significant and clinically meaningful improvement,' and provided specific metrics such as median PFS improvements, discontinuation rates, and market size estimates. The tone was assured and detailed about clinical achievements and commercial readiness.

Guidance Reliability Pending · <3Q data

Investor Lens

The investment thesis for Celcuity has strengthened significantly with the positive VIKTORIA-1 mutant cohort results, which validate multi-target PAM pathway inhibition and expand the potential label to all PIK3CA status patients. The expansion of VIKTORIA-2 into the endocrine-sensitive first-line setting opens a much larger addressable market (~60,000 new U.S. patients annually) and, if successful, could transform the standard of care. The subcutaneous formulation effort addresses long-term treatment convenience and strengthens intellectual property. Key near-term catalysts include the ASCO late-breaking presentation on June 2nd and the PDUFA decision by July 17th. Investors should watch for detailed efficacy and safety data from the mutant cohort and any FDA communication ahead of the decision.

AI-generated concall tone analysis · Updated 2026-06-08 · Not investment advice

🎙 Management Tone Confident Specific → Stable 4 quarters Full tone analysis in Intelligence →

📊 MIXED Celcuity reports $52.8M net loss; advancing gedatolisib for breast cancer.

Revenue & Profitability

For Q1 2026, Celcuity reported a GAAP net loss of $52.8 million ($0.97 per share) and a non-GAAP adjusted net loss of $46.8 million ($0.86 per share). Research and development expenses were $33.1 million, and selling, general, and administrative expenses were $17.4 million. Cash, cash equivalents, and short-term investments totaled $387.1 million at quarter end. The company expects cash and investments to finance operations through 2027.

Outlook

Management expressed optimism about the potential approval of gedatolisib by July 17, 2026, based on favorable interactions with the FDA. They believe the drug can become a new standard of care in second-line therapy for HR-positive, HER2-negative advanced breast cancer regardless of PIK3CA mutation status. No macro industry headwinds were discussed.

Growth Drivers

Growth is driven by the potential approval and commercial launch of gedatolisib in the second-line setting, with an estimated peak annual revenue of up to $2.5 billion. Expansion into first-line treatment via the amended VIKTORIA-2 trial (endocrine-resistant and endocrine-sensitive populations) and development of a subcutaneous formulation are key growth levers. Additional growth may come from the prostate cancer program (gedatolisib plus darolutamide).

Balance Sheet & CapEx

Not discussed in this earnings call.

Margins

Not discussed in this earnings call. The company is pre-revenue and currently reporting net losses.

Key Risks

Key risks include the uncertainty of FDA approval by the PDUFA date (July 17, 2026) and potential delays. Competitive pressures from other PI3K and AKT inhibitors are noted. The company faces risks related to trial enrollment, demonstrating overall survival benefit in first-line studies, and the ability to manage safety profiles. Management also noted the need for clinical equivalence studies for the subcutaneous formulation.

Generated by AI · Q1 2026 results · Not investment advice

✓ 📞 Earnings Call Transcripts (5 quarters) submit a missing quarter

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📞 Earnings Call Transcripts (5)

Q1 2026 Q1 2026 2026-05-14

Q1 2026 saw positive phase III results for gedatolisib in advanced breast cancer, expansion of clinical programs, and full commercial launch readiness. Net loss increased year-over-year, but cash reserves are expected to fund operations through 2027.

Q4 2025 Q4 2025 2026-03-25

Achieved key milestones in 2025, including FDA priority review for gedatolisib and strong pivotal trial results. Net loss increased due to R&D and commercial investments, but cash reserves are expected to fund operations through 2027. Positive market feedback and a large addressable market support a strong outlook.

Q3 2025 Q3 2025 2025-11-12

Significant clinical and regulatory milestones were achieved, including positive phase III data for Gedatolisib and FDA acceptance for NDA submission. Financially, net loss increased due to higher R&D and G&A expenses, but liquidity remains strong with $455 million in cash and expanded credit facilities.

Q2 2025 Q2 2025 2025-08-14

Q2 2025 saw major clinical milestones, strong phase III data for gedatolisib, and a $287M capital raise. Net loss widened due to increased R&D, but cash runway now extends through 2027, supporting a potential launch in a $5B market.

Q1 2025 Q1 2025 2025-05-14

Q1 2025 saw increased R&D and net losses as multiple late-stage clinical trials advanced, with key data readouts expected in 2025. Cash reserves are projected to fund operations through 2026, and a new endometrial cancer collaboration was announced.

📊 Analysis Methodology

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