Celcuity (CELC) AI Stock Analysis

• Market Cap: $5.43B
• Dividend Yield: N/A
• Average Volume (3M): 675.91K
• Price to Earnings (P/E): ―
• Beta (1Y): 0.33
• Revenue Growth: N/A
• EPS Growth: -40.75%
• Country: US
• Employees: 87
• Sector: Healthcare
• Sector Strength: 45
• Industry: Biotechnology
• EPS (TTM): -0.92
• Shares Outstanding: 46,271,260
• 10 Day Avg. Volume: 607,916
• 30 Day Avg. Volume: 675,906
• PEG Ratio: -0.89
• Price to Book (P/B): 4.47
• Price to Sales (P/S): 0.00
• P/FCF Ratio: -6.17
• Enterprise Value/Market Cap: 1.02
• Enterprise Value/Revenue: N/A
• Enterprise Value/Gross Profit: -73.69K
• Enterprise Value/Ebitda: -40.92
• 1Y Price Target: $106.50
• Price Target Upside: -9.17% Downside
• Rating Consensus: Strong Buy
• Number of Analyst Covering: 9
• EPS Forecast (FY): N/A
• Revenue Forecast (FY): N/A

• Rating: 56 Neutral
• Price Target: $117.00 ▼(-0.21% Downside)

The score is held back primarily by weak financial performance (pre-revenue, accelerating losses/cash burn, and higher leverage). This is partially offset by constructive technical strength and a positive earnings-call outlook driven by strong clinical data, NDA progress, and stated funding runway; valuation remains difficult given negative earnings and no dividend.

Positive Factors

Regulatory Progress & Phase III Data

Acceptance of an NDA under the FDA Real-Time Oncology Review and robust Phase III efficacy signals represent a structural de-risking step for a clinical-stage biotech. If approved, gedatolisib could convert research-stage assets into a commercial franchise, materially changing the firm’s long-term revenue profile and strategic optionality.

Large Addressable Market

A sizable total addressable market and multi‑billion peak revenue potential support sustainable commercial opportunity if the drug reaches approval and achieves uptake. This structural market size underpins strategic investment in launch capabilities and long-term revenue scaling for the company.

Near-Term Funding Runway and Financing Completed

Material recent financing and an enlarged term loan provide multi-year operational runway through key regulatory milestones. Durable access to capital reduces immediate dilution/solvency risk and gives management time to pursue approval, launch preparations, or partnerships without immediate revenue dependency.

Negative Factors

Pre-Revenue with Widening Losses

Sustained pre-revenue operations with sharply increasing losses indicate persistent negative profitability and structural cash burn. Over months, this weakens internal funding capacity and forces reliance on external financing, impairing long-term financial resilience until commercial revenues emerge.

Material Increase in Leverage

A substantial rise in debt relative to equity materially alters capital structure and increases fixed servicing obligations. Higher leverage reduces financial flexibility, magnifies refinancing risk across cycles, and can constrain R&D or commercial investments if cash generation remains negative.

Negative Cash Generation & Funding Dependence

Persistently negative operating and free cash flow forces dependence on external capital, increasing dilution and conditionality from lenders/partners. Over a multi‑month time horizon this structural cash deficit heightens execution risk for trials, regulatory filings, and commercialization investments.

Celcuity Business Overview & Revenue Model

Company Description

Celcuity Inc., a clinical stage biotechnology company, focuses on the development of molecularly targeted therapies for cancer patients in the United States. The company's CELsignia diagnostic platform uses a patient's living tumor cells to identify the specific abnormal cellular process driving a patient's cancer and the related targeted therapy for the treatment. Its drug candidate includes Gedatolisib, which selectively targets various class I isoforms of PI3K and mammalian target of rapamycin and focus on the treatment of patients with hormone receptor positive, HER2-negative, and advanced or metastatic breast cancer. The company is also developing CELsignia MP test, a qualitative laboratory developed test that measures HER2, c-Met, and PI3K signaling activity in breast and ovarian tumor cells. It had a license agreement with Pfizer, Inc. for the development and commercialization rights to Gedatolisib. Celcuity Inc. was founded in 2011 and is headquartered in Minneapolis, Minnesota.

How the Company Makes Money

Celcuity generates revenue primarily through the commercialization of its CELsignia platform. The company's revenue model is based on partnerships with pharmaceutical companies and healthcare providers who utilize its diagnostic tests to optimize cancer treatment strategies. Celcuity collaborates with pharmaceutical firms to enhance the efficacy of their targeted therapies, potentially sharing in the economic benefits of improved treatment outcomes. Additionally, the company may receive payments for conducting clinical trials and providing diagnostic services to institutions focused on personalized cancer treatment.

Celcuity Financial Statement Overview

Summary

Pre-revenue ($0 revenue) with sharply widening losses and cash burn (TTM net loss -$162.7M; TTM operating cash flow -$144.7M; TTM FCF -$144.9M). Leverage increased materially (TTM debt $320.3M; ~2.74x debt-to-equity), adding financing risk despite positive equity ($117.0M).

Income Statement

Celcuity remains a pre-revenue business (revenue is $0 across annual periods and TTM (Trailing-Twelve-Months)), with losses widening materially. Net loss expanded from about -$9.5M (2020) to -$111.8M (2024) and further to -$162.7M in TTM, indicating a sharply higher burn profile. Profitability is deeply negative (TTM net margin is heavily negative), which is typical for early-stage biotech but still a clear earnings-quality and scalability risk until revenue emerges.

Balance Sheet

The balance sheet shows meaningful leverage: total debt increased sharply to $320.3M in TTM from $98.0M in 2024, pushing debt to ~2.74x equity. Equity is still positive ($117.0M in TTM), providing some cushion, but losses are large relative to equity (TTM return on equity is strongly negative), which can pressure future financing flexibility. Overall, the company has assets ($476.0M TTM) but the capital structure has become materially more debt-heavy versus prior years.

Cash Flow

Cash generation is negative and worsening in absolute dollars: operating cash flow was -$83.5M (2024) and -$144.7M in TTM, with free cash flow similarly negative (-$144.9M TTM). A positive sign is that free cash flow roughly tracks net loss (TTM free cash flow to net income is ~0.97), suggesting cash burn is broadly consistent with reported losses rather than being driven by large non-cash distortions. Still, the business remains dependent on external funding given sustained negative operating and free cash flow.

Breakdown	TTM	Dec 2024	Dec 2023	Dec 2022	Dec 2021	Dec 2020
Income Statement
Total Revenue	0.00	0.00	0.00	0.00	0.00	0.00
Gross Profit	-75.25K	0.00	0.00	0.00	0.00	0.00
EBITDA	-135.54M	-101.37M	-58.31M	-39.18M	-28.04M	-9.17M
Net Income	-162.72M	-111.78M	-63.78M	-40.37M	-29.61M	-9.47M
Balance Sheet
Total Assets	476.00M	245.12M	191.22M	175.70M	85.91M	12.96M
Cash, Cash Equivalents and Short-Term Investments	454.98M	235.10M	180.58M	168.59M	84.29M	11.66M
Total Debt	320.35M	97.95M	37.45M	35.24M	14.89M	262.49K
Total Liabilities	359.04M	129.50M	51.45M	41.93M	17.20M	1.25M
Stockholders Equity	116.96M	115.62M	139.77M	133.77M	68.71M	11.70M
Cash Flow
Free Cash Flow	-144.89M	-83.72M	-53.91M	-36.17M	-20.39M	-7.24M
Operating Cash Flow	-144.65M	-83.47M	-53.81M	-36.01M	-20.31M	-7.15M
Investing Cash Flow	-129.93M	-63.07M	-5.01M	-144.03M	-81.40K	-89.37K
Financing Cash Flow	336.23M	138.39M	64.91M	120.33M	93.04M	137.97K

Celcuity Technical Analysis

• Technical Analysis Sentiment: Positive
• Last Price: 117.25
• 50DMA: Positive
• 100DMA: Positive
• 200DMA: Positive
• MACD: Negative
• RSI: Neutral
• STOCH: Neutral

Evaluating momentum and price trends is crucial in stock analysis to make informed investment decisions. For CELC, the sentiment is Positive. The current price of 117.25 is above the 20-day moving average (MA) of 107.25, above the 50-day MA of 102.86, and above the 200-day MA of 51.86, indicating a bullish trend. The MACD of 3.75 indicates Negative momentum. The RSI at 61.29 is Neutral, neither overbought nor oversold. The STOCH value of 77.17 is Neutral, not indicating any strong overbought or oversold conditions. Overall, these indicators collectively point to a Positive sentiment for CELC.

Celcuity Peers Comparison

Name	Overall Rating	Market Cap	P/E Ratio	ROE	Dividend Yield	Revenue Growth	EPS Growth
IDYA	63 Neutral	$3.05B	-18.14	-14.15%	―	5376.27%	20.97%
BLTE	62 Neutral	$5.84B	-86.28	-32.30%	―	―	-73.27%
TARS	60 Neutral	$2.89B	-31.88	-28.35%	―	182.44%	47.21%
CELC	56 Neutral	$5.43B	-31.20	-122.04%	―	―	-40.75%
Sector *	51 Neutral	$7.86B	-0.30	-43.30%	2.27%	22.53%	-2.21%
APGE	51 Neutral	$4.95B	-16.37	-38.41%	―	―	-58.35%

Celcuity Corporate Events

Celcuity Submits NDA for Gedatolisib to FDA

On November 17, 2025, Celcuity Inc. announced the submission of its New Drug Application (NDA) to the U.S. Food and Drug Administration for gedatolisib, targeting hormone receptor positive, HER2-negative, PIK3CA wild-type advanced breast cancer. This submission, under the FDA’s Real-Time Oncology Review program, is based on promising Phase 3 VIKTORIA-1 trial results, showing significant efficacy in reducing disease progression risk. The NDA marks a significant milestone for Celcuity, potentially altering treatment practices for HR+/HER2- advanced breast cancer patients.

The most recent analyst rating on (CELC) stock is a Hold with a $94.00 price target. To see the full list of analyst forecasts on Celcuity stock, see the CELC Stock Forecast page.