Celcuity's Net Loss Widens to $126M Amid Soaring R&D Costs

TL;DR

**CELC is burning cash fast on R&D, but the massive financing rounds suggest big bets on gedatolisib's Phase 3 success.**

AI Summary

Celcuity Inc. (CELC) reported a significant increase in net loss for the nine months ended September 30, 2025, reaching $126.069 million, up from $75.126 million in the prior year, primarily driven by increased operating expenses. Research and development expenses surged to $107.364 million for the nine months ended September 30, 2025, compared to $70.732 million in the same period of 2024, reflecting intensified clinical trial activities for gedatolisib. General and administrative expenses also rose substantially to $15.627 million from $6.105 million year-over-year. The company's cash and cash equivalents increased significantly to $74.252 million as of September 30, 2025, from $22.515 million at December 31, 2024, largely due to $336.111 million in net cash provided by financing activities, including $195.476 million from convertible note payable and $91.823 million from an equity offering. Total assets nearly doubled to $476.004 million from $245.123 million, while total liabilities increased to $359.041 million from $129.504 million, mainly due to new convertible debt of $195.083 million. The company continues to operate without revenue, focusing on its clinical-stage biotechnology pipeline, including Phase 3 trials for gedatolisib in breast cancer.

Why It Matters

Celcuity's substantial increase in R&D spending, up 51.8% to $107.364 million, signals aggressive advancement of its gedatolisib clinical programs, particularly the VIKTORIA-1 and VIKTORIA-2 Phase 3 trials. For investors, this indicates a high-burn rate but also potential for significant future value if trials succeed, contrasting with the competitive landscape where other PI3K/AKT/mTOR inhibitors are also being developed. Employees benefit from continued investment in the pipeline, while customers (future patients) could see new treatment options. The broader market watches for breakthroughs in HR+/HER2- advanced breast cancer, a significant unmet medical need.

Risk Assessment

Risk Level: high — The company reported a net loss of $126.069 million for the nine months ended September 30, 2025, and has not generated any revenue to date, indicating a complete reliance on financing activities. Total liabilities increased to $359.041 million, including $195.083 million in new convertible debt, significantly raising financial leverage and future obligations.

Analyst Insight

Investors should closely monitor the progress and upcoming data readouts from Celcuity's gedatolisib clinical trials, especially VIKTORIA-1 and VIKTORIA-2. Given the high burn rate and lack of revenue, new investments should be considered highly speculative, contingent on positive clinical outcomes and further successful capital raises.

Financial Highlights

debt To Equity

N/A

revenue

$0

operating Margin

N/A

total Assets

$476.004M

total Debt

$195.083M

net Income

-$126.069M

eps

-$0.92

gross Margin

N/A

cash Position

$74.252M

revenue Growth

N/A

Key Numbers

• $126.069M — Net Loss (for the nine months ended September 30, 2025, up from $75.126M in 2024)
• $107.364M — Research and Development Expenses (for the nine months ended September 30, 2025, up from $70.732M in 2024)
• $74.252M — Cash and Cash Equivalents (as of September 30, 2025, up from $22.515M at December 31, 2024)
• $336.111M — Net Cash Provided by Financing Activities (for the nine months ended September 30, 2025)
• $195.083M — Convertible Debt (newly reported as of September 30, 2025)
• $476.004M — Total Assets (as of September 30, 2025, up from $245.123M at December 31, 2024)
• $359.041M — Total Liabilities (as of September 30, 2025, up from $129.504M at December 31, 2024)
• $0.92 — Net Loss Per Share (Diluted) (for the three months ended September 30, 2025, compared to $0.70 in 2024)

Key Players & Entities

• Celcuity Inc. (company) — clinical-stage biotechnology company
• gedatolisib (drug) — lead therapeutic candidate
• Brian F. Sullivan (person) — co-founder of Celcuity Inc.
• Dr. Lance G. Laing (person) — co-founder of Celcuity Inc.
• U.S. Food and Drug Administration (regulator) — regulatory approval body
• The Nasdaq Stock Market LLC (company) — exchange where CELC is registered
• Bloomberg (company) — financial news organization
• SEC (regulator) — Securities and Exchange Commission

FAQ

Risk Factors

• Clinical Trial Execution and Delays [high — operational]: The company's primary focus on clinical-stage development, particularly for gedatolisib, exposes it to significant risks related to trial timelines and outcomes. Delays in Phase 3 trials for breast cancer could impact future revenue generation and require additional capital. The substantial increase in R&D expenses to $107.364 million for the nine months ended September 30, 2025, highlights the cost and complexity of these trials.
• Burn Rate and Future Funding Needs [high — financial]: Celcuity is operating without revenue and has a significant net loss of $126.069 million for the nine months ended September 30, 2025. While cash and cash equivalents increased to $74.252 million due to financing activities, the high operating expenses, especially R&D, suggest a substantial ongoing cash burn rate. Future funding will be critical to sustain operations and clinical development.
• Increased Debt Load [medium — financial]: The company has taken on significant new debt, with convertible debt increasing to $195.083 million as of September 30, 2025. This substantially increases total liabilities to $359.041 million. The conversion terms of this debt could lead to significant dilution for existing shareholders.
• Drug Approval and Regulatory Hurdles [high — regulatory]: As a clinical-stage biotechnology company, Celcuity faces inherent risks associated with obtaining regulatory approval for its drug candidates, such as gedatolisib. The success of these drugs is contingent on rigorous clinical trials and navigating complex regulatory pathways with agencies like the FDA. Failure to gain approval would severely impact the company's prospects.
• Competition in Oncology Market [medium — market]: The oncology market is highly competitive, with numerous established pharmaceutical companies and emerging biotechs developing novel therapies. Celcuity's success depends on demonstrating a significant clinical benefit for gedatolisib compared to existing treatments and pipeline competitors.

Industry Context

Celcuity operates in the highly competitive and capital-intensive biotechnology sector, specifically focusing on oncology. The industry is characterized by long development cycles, high R&D costs, and significant regulatory hurdles. Success hinges on innovation, clinical trial efficacy, and securing substantial funding to advance drug candidates through development and commercialization.

Regulatory Implications

As a clinical-stage biotechnology company, Celcuity is subject to stringent regulatory oversight from bodies like the FDA. The success of its drug candidates, particularly gedatolisib, depends on meeting rigorous safety and efficacy standards through clinical trials. Any delays or adverse findings in these trials could have significant implications for regulatory approval and market access.

What Investors Should Do

1. Monitor R&D spend and clinical trial progress for gedatolisib.
2. Assess the company's cash burn rate and future financing needs.
3. Evaluate the impact of new convertible debt on the capital structure.

Key Dates

• 2025-09-30: Nine months ended September 30, 2025 financial results reported — Indicates significant increase in net loss and R&D expenses, alongside substantial financing activities and asset growth.
• 2025-09-30: Cash and cash equivalents reached $74.252 million — Demonstrates improved liquidity due to successful financing rounds, crucial for funding ongoing clinical trials.
• 2025-09-30: Total liabilities increased to $359.041 million — Reflects the issuance of new convertible debt, increasing financial leverage and potential future dilution.
• 2024-09-30: Nine months ended September 30, 2024 financial results reported — Provides a baseline for comparison, showing a lower net loss and R&D spend in the prior year.

Glossary

Gedatolisib

A clinical-stage drug candidate being developed by Celcuity, primarily for breast cancer. (It is the company's lead asset, driving the majority of its research and development expenses and future revenue potential.)

Convertible Note Payable

A type of debt that can be converted into equity (stock) of the issuing company under certain conditions. (Celcuity has issued a significant amount of this debt ($195.083 million), which impacts its liabilities and could lead to future shareholder dilution.)

Clinical Trial Activities

The process of testing new drugs or treatments in humans to assess their safety and efficacy. (Celcuity's operations are heavily reliant on these activities, which are the primary driver of its substantial R&D expenses.)

Net Loss Per Share (Diluted)

The portion of a company's profit or loss allocated to each outstanding share of common stock, assuming all dilutive potential common shares (like convertible debt) were exercised. (Indicates the profitability (or lack thereof) on a per-share basis, with a diluted EPS of -$0.92 for the three months ended September 30, 2025.)

Year-Over-Year Comparison

Compared to the prior year, Celcuity has experienced a significant increase in its net loss, rising to $126.069 million for the nine months ended September 30, 2025, from $75.126 million in the same period of 2024. This widening loss is primarily driven by a surge in R&D expenses, which more than doubled to $107.364 million, reflecting intensified clinical trial activities. While total assets have nearly doubled to $476.004 million, this is largely offset by a substantial increase in total liabilities to $359.041 million, mainly due to new convertible debt. The company's cash position has improved significantly to $74.252 million, a direct result of substantial financing activities.

Key Financial Figures

• $0.001 — nge on which registered Common Stock, $0.001 par value per share CELC The Nasdaq

Filing Documents

• form10-q.htm (10-Q) — 972KB
• ex31-1.htm (EX-31.1) — 18KB
• ex31-2.htm (EX-31.2) — 19KB
• ex32-1.htm (EX-32.1) — 7KB
• ex32-2.htm (EX-32.2) — 7KB
• 0001493152-25-022401.txt ( ) — 4846KB
• celc-20250930.xsd (EX-101.SCH) — 35KB
• celc-20250930_cal.xml (EX-101.CAL) — 45KB
• celc-20250930_def.xml (EX-101.DEF) — 165KB
• celc-20250930_lab.xml (EX-101.LAB) — 357KB
• celc-20250930_pre.xml (EX-101.PRE) — 275KB
• form10-q_htm.xml (XML) — 602KB

FINANCIAL INFORMATION

PART I. FINANCIAL INFORMATION

Financial Statements (unaudited)

ITEM 1. Financial Statements (unaudited) 3 Condensed Balance Sheets as of September 30, 2025 and December 31, 2024 3 Condensed Statements of Operations for the three months and nine months ended September 30, 2025 and 2024 4 Condensed Statements of Stockholders' Equity for the three months and nine months ended September 30, 2025 5 Condensed Statements of Stockholders' Equity for the three months and nine months ended September 30, 2024 6 Condensed Statements of Cash Flows for the nine months ended September 30, 2025 and 2024 7 Notes to Unaudited Condensed Financial Statements 8

Management's Discussion and Analysis of Financial Condition and Results of Operations

ITEM 2. Management's Discussion and Analysis of Financial Condition and Results of Operations 20

Quantitative and Qualitative Disclosures About Market Risk

ITEM 3. Quantitative and Qualitative Disclosures About Market Risk 38

Controls and Procedures

ITEM 4. Controls and Procedures 38

OTHER INFORMATION

PART II. OTHER INFORMATION

Legal Proceedings

ITEM 1. Legal Proceedings 39

Risk Factors

ITEM 1A. Risk Factors 39

Unregistered Sales of Equity Securities and Use of Proceeds

ITEM 2. Unregistered Sales of Equity Securities and Use of Proceeds 42

Defaults Upon Senior Securities

ITEM 3. Defaults Upon Senior Securities 42

Mine Safety Disclosures

ITEM 4. Mine Safety Disclosures 42

Other Information

ITEM 5. Other Information 42

Exhibits

ITEM 6. Exhibits 43

Signatures

Signatures 44 As used in this report, the terms "we," "us," "our," "Celcuity," and the "Company" mean Celcuity Inc., unless the context indicates another meaning. 2 PART I. FINANCIAL INFORMATION ITEM 1. Financial Statements Celcuity Inc. Condensed Balance Sheets (in thousands, except share and par value amounts) September 30, 2025 December 31, 2024 (unaudited) Assets Current Assets: Cash and cash equivalents $ 74,252 $ 22,515 Investments 380,726 212,589 Other current assets 20,519 9,467 Total current assets 475,497 244,571 Property and equipment, net 417 336 Operating lease right-of-use assets 90 216 Total Assets $ 476,004 $ 245,123 Liabilities and Stockholders' Equity: Current Liabilities: Accounts payable $ 11,418 $ 9,366 Operating lease liabilities 96 172 Accrued expenses 27,278 22,185 Total current liabilities 38,792 31,723 Operating lease liabilities - 54 Note payable, non-current 125,166 97,727 Convertible debt 195,083 - Total Liabilities 359,041 129,504 Commitments and Contingencies (Note 5) - - Stockholders' Equity: Preferred stock, $ 0.001 par value: 2,500,000 shares authorized; 188,838 and 317,577 shares issued and outstanding as of September 30, 2025 and December 31, 2024, respectively. - - Common stock, $ 0.001 par value: 95,000,000 shares authorized; 43,274,548 and 37,143,242 shares issued and outstanding as of September 30, 2025 and December 31, 2024, respectively. 43 37 Additional paid-in capital 514,844 387,437 Accumulated deficit ( 397,924 ) ( 271,855 ) Total Stockholders' Equity 116,963 115,619 Total Liabilities and Stockholders' Equity $ 476,004 $ 245,123 See accompanying notes to the condensed financial statements. 3 Celcuity Inc. Condensed (in thousands, except share and per share amounts) (unaudited) 2025 2024 2025 2024 Three Months Ended September 30, Nine Months Ended September 30,

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