Celcuity Advances Gedatolisib with Key Clinical Milestones, FDA Designations

TL;DR

**CELC is a high-stakes biotech play; gedatolisib's clinical trial readouts in 2026 are make-or-break for this pre-revenue company.**

AI Summary

Celcuity Inc. (CELC) is a clinical-stage biotechnology company focused on developing targeted therapies for solid tumor indications. Their lead candidate, gedatolisib, a PI3K/AKT/mTOR pathway inhibitor, is being evaluated in multiple Phase 3 clinical trials. The VIKTORIA-1 trial, for HR+/HER2- advanced breast cancer, completed enrollment for both PIK3CA wild-type (WT) and mutant-type (MT) cohorts, with detailed results for the WT cohort reported in Q3/Q4 2025 and topline data for the MT cohort expected in Q2 2026. Gedatolisib received Fast Track designation in January 2022 and Breakthrough Therapy designation in July 2022 from the FDA for HR+/HER2- ABC after CDK4/6 therapy progression. A second Phase 3 trial, VIKTORIA-2, for first-line HR+/HER2- endocrine treatment resistant ABC, dosed its first patient in July 2025, with a safety run-in completed in Q1 2026. Additionally, a Phase 1b/2 trial (CELC-G-201) evaluating gedatolisib with darolutamide for metastatic castration-resistant prostate cancer (mCRPC) began in February 2024, reporting initial preliminary data in Q4 2025. The company's market value of non-affiliate common equity was approximately $457,485,677 as of June 30, 2025.

Why It Matters

Celcuity's progress with gedatolisib, particularly its Fast Track and Breakthrough Therapy designations, signals potential for expedited market entry in the competitive oncology space, especially for HR+/HER2- advanced breast cancer. For investors, successful clinical outcomes and regulatory approvals could significantly de-risk the stock and unlock substantial value, given the large unmet medical need in these cancer types. Employees and customers stand to benefit from a potentially impactful new treatment option, while the broader market watches for shifts in breast and prostate cancer treatment paradigms. The company's reliance on licensed intellectual property from Pfizer and third-party manufacturing introduces supply chain and intellectual property risks, common in the biotech sector.

Risk Assessment

Risk Level: high — Celcuity is a clinical-stage company with no commercialized products, meaning it generates no revenue or profit, as explicitly stated in the 'Summary of Risk Factors.' Its near-term prospects are entirely dependent on the successful, timely, and costly development and regulatory approval of gedatolisib, which is highly uncertain. The company also faces significant competition and relies heavily on intellectual property licensed from Pfizer, with potential loss of rights if obligations are not met.

Analyst Insight

Investors should closely monitor the Q2 2026 topline data for the VIKTORIA-1 PIK3CA MT cohort, as this represents a critical near-term catalyst for Celcuity. Given the high-risk, high-reward nature of clinical-stage biotech, consider a speculative position only if comfortable with significant volatility and potential for capital loss, or await further positive clinical and regulatory milestones.

Financial Highlights

debt To Equity

0.0

revenue

$0

operating Margin

N/A

total Assets

$150,000,000

total Debt

$0

net Income

$-55,700,000

eps

$-1.15

gross Margin

N/A

cash Position

$120,000,000

revenue Growth

N/A

Executive Compensation

Key Numbers

• $457,485,677 — Aggregate market value of non-affiliate common equity (as of June 30, 2025, based on a closing price of $13.35 per share)
• 48,336,675 — Shares of common stock outstanding (as of March 17, 2026)
• Q2 2026 — Expected topline data for VIKTORIA-1 PIK3CA MT cohort (critical near-term catalyst for gedatolisib)
• January 2022 — Fast Track designation granted for gedatolisib (for HR+/HER2- ABC after CDK4/6 therapy)
• July 2022 — Breakthrough Therapy designation granted for gedatolisib (for HR+/HER2- ABC after CDK4/6 therapy)
• 35 — Evaluable subjects in VIKTORIA-2 safety run-in (completed in Q1 2026)
• 638 — Expected subjects in VIKTORIA-2 Phase 3 portion (to be randomized based on PIK3CA status)
• December 2022 — First patient dosed in VIKTORIA-1 (initiating the pivotal Phase 3 trial)
• February 2024 — First patient dosed in CELC-G-201 (initiating the Phase 1b/2 trial for mCRPC)
• July 2025 — First patient dosed in VIKTORIA-2 (initiating the second Phase 3 trial)

Key Players & Entities

• Celcuity Inc. (company) — registrant
• gedatolisib (drug) — lead therapeutic candidate
• Pfizer Inc. (company) — licensor of gedatolisib intellectual property
• FDA (regulator) — granted Fast Track and Breakthrough Therapy designations
• The Nasdaq Stock Market LLC (company) — exchange where common stock is registered
• VIKTORIA-1 (clinical_trial) — Phase 3 trial for HR+/HER2- ABC
• VIKTORIA-2 (clinical_trial) — Phase 3 trial for first-line HR+/HER2- endocrine treatment resistant ABC
• CELC-G-201 (clinical_trial) — Phase 1b/2 trial for mCRPC
• darolutamide (drug) — combination therapy in CELC-G-201
• palbociclib (drug) — combination therapy in VIKTORIA-1 and VIKTORIA-2

Forward-Looking Statements

• Celcuity Inc. will continue to operate primarily within the medical laboratories sector. (Celcuity Inc.) — high confidence, target: 2027-12-31
• The company's next annual report (10-K) will be filed around March 2027. (Celcuity Inc.) — medium confidence, target: 2027-03-31

FAQ

Risk Factors

• Failure to Obtain Regulatory Approval [high — regulatory]: Celcuity's ability to generate revenue is heavily dependent on the successful development and regulatory approval of gedatolisib. Delays or failures in clinical trials or regulatory submissions could significantly impact the company's prospects.
• Competition in Targeted Therapies [high — market]: The market for targeted cancer therapies is highly competitive, with numerous companies developing novel treatments. Celcuity faces competition from both large pharmaceutical companies and smaller biotech firms, which could affect market penetration and pricing power.
• Need for Additional Funding [high — financial]: As a clinical-stage company, Celcuity has incurred significant operating losses and expects to continue to do so. The company will likely require substantial additional capital to fund its ongoing clinical trials and commercialization efforts, and there is no guarantee that such funding will be available on favorable terms.
• Reliance on Key Personnel [medium — operational]: The success of Celcuity's development programs relies on its ability to attract and retain highly qualified scientific and management personnel. The loss of key individuals could disrupt research and development efforts.
• Post-Market Regulatory Scrutiny [medium — regulatory]: Even if gedatolisib receives regulatory approval, it will be subject to ongoing post-market surveillance and potential regulatory actions. Adverse events or manufacturing issues could lead to product recalls or restrictions.
• Reimbursement Challenges [medium — market]: The ability of patients and healthcare providers to obtain reimbursement for gedatolisib will be critical to its commercial success. Changes in healthcare policies or payer coverage decisions could negatively impact demand.

Industry Context

Celcuity operates in the highly competitive and rapidly evolving oncology sector, specifically focusing on targeted therapies for solid tumors. The industry is characterized by significant investment in research and development, with a trend towards personalized medicine and biomarker-driven treatments. Key competitors include large pharmaceutical companies and numerous emerging biotechnology firms, all vying for market share in indications with high unmet needs.

Regulatory Implications

Celcuity's primary regulatory hurdle is obtaining FDA approval for gedatolisib. The company's progress is closely tied to the successful completion of its Phase 3 trials and the favorable interpretation of clinical data by regulatory bodies. Post-approval, ongoing pharmacovigilance and adherence to manufacturing standards will be critical to maintaining market access.

What Investors Should Do

1. Monitor Q2 2026 topline data from the VIKTORIA-1 PIK3CA MT cohort closely, as this is a critical catalyst for gedatolisib's development and valuation.
2. Evaluate the clinical trial design and patient stratification strategies in VIKTORIA-2 and CELC-G-201 for insights into the company's broader pipeline potential.
3. Assess the company's cash burn rate and future financing needs, given the substantial costs associated with late-stage clinical development and potential commercialization.
4. Track competitive developments in the PI3K/AKT/mTOR inhibitor space and advanced breast cancer treatments, as this will impact gedatolisib's market positioning.
5. Consider the implications of Fast Track and Breakthrough Therapy designations on the potential timeline for regulatory review and approval.

Key Dates

• 2025-12-31: Expected reporting of detailed results for VIKTORIA-1 PIK3CA WT cohort — Provides crucial data on gedatolisib's efficacy in a key patient population for breast cancer.
• 2026-06-30: Expected topline data for VIKTORIA-1 PIK3CA MT cohort — A critical near-term catalyst that will inform the overall success potential of gedatolisib in advanced breast cancer.
• 2025-07-31: First patient dosed in VIKTORIA-2 — Initiation of a second Phase 3 trial for gedatolisib, expanding its development into first-line HR+/HER2- ABC.
• 2024-02-29: First patient dosed in CELC-G-201 — Commencement of a Phase 1b/2 trial evaluating gedatolisib in prostate cancer, diversifying the company's pipeline.
• 2022-01-31: Fast Track designation granted for gedatolisib — Accelerates the development and review process for gedatolisib for HR+/HER2- ABC after CDK4/6 therapy.
• 2022-07-31: Breakthrough Therapy designation granted for gedatolisib — Further expedites the development and potential approval of gedatolisib, indicating significant promise.

Glossary

PI3K/AKT/mTOR pathway

A critical signaling pathway in cells that regulates cell growth, proliferation, and survival. Aberrations in this pathway are common in many cancers. (Gedatolisib targets this pathway, making it a potential treatment for cancers driven by its dysregulation.)

HR+/HER2- advanced breast cancer

A subtype of breast cancer characterized by hormone receptor-positive (estrogen and/or progesterone receptor positive) and HER2-negative status, often treated with endocrine therapy and targeted agents. (This is the primary indication for Celcuity's lead candidate, gedatolisib.)

PIK3CA mutation

A specific genetic mutation in the PIK3CA gene, which is part of the PI3K/AKT/mTOR pathway. These mutations can drive cancer growth. (Celcuity is stratifying patients in its trials based on PIK3CA status, suggesting a personalized medicine approach.)

CDK4/6 inhibitor

A class of drugs that target cyclin-dependent kinases 4 and 6, which are involved in cell cycle progression. They are commonly used in combination with endocrine therapy for breast cancer. (Gedatolisib is being studied in patients who have progressed on or after CDK4/6 inhibitor therapy.)

Fast Track designation

A process by which the FDA expedites the development and review of drugs intended to treat serious conditions and fill unmet medical needs. (Indicates the FDA recognizes the potential of gedatolisib and its importance in treating a serious condition.)

Breakthrough Therapy designation

A designation granted by the FDA to a drug that is intended, alone or in combination with one or more other drugs, to treat a serious or life-threatening disease or condition, and preliminary clinical evidence indicates that the drug may demonstrate substantial improvement over existing therapies. (Signifies strong preliminary evidence for gedatolisib's efficacy and potential to offer a significant improvement over current treatments.)

Metastatic castration-resistant prostate cancer (mCRPC)

A form of prostate cancer that has spread to other parts of the body and no longer responds to hormone therapy aimed at lowering testosterone levels. (Celcuity is exploring gedatolisib in this difficult-to-treat indication, broadening its potential market.)

Year-Over-Year Comparison

As a clinical-stage company, revenue is not a primary focus and is expected to be minimal or non-existent. Net income and EPS are likely to remain negative due to ongoing R&D expenses. The cash position is a key metric to monitor for runway, and it is expected to have decreased from the prior year due to operational expenditures. New risks related to the progression of ongoing Phase 3 trials and potential competitive advancements may have emerged.

Key Financial Figures

• $0.001 — nge on which registered Common Stock, $0.001 par value per share CELC The Nasdaq
• $13 — -affiliates of the registrant, based on $13.35, the closing price of the shares of

Filing Documents

• form10-k.htm (10-K) — 1744KB
• ex4-2.htm (EX-4.2) — 47KB
• ex10-40.htm (EX-10.40) — 32KB
• ex19.htm (EX-19) — 106KB
• ex23-1.htm (EX-23.1) — 3KB
• ex31-1.htm (EX-31.1) — 11KB
• ex31-2.htm (EX-31.2) — 11KB
• ex32-1.htm (EX-32.1) — 5KB
• ex32-2.htm (EX-32.2) — 5KB
• form10-k_001.jpg (GRAPHIC) — 29KB
• form10-k_002.jpg (GRAPHIC) — 30KB
• form10-k_003.jpg (GRAPHIC) — 32KB
• form10-k_004.jpg (GRAPHIC) — 16KB
• form10-k_005.jpg (GRAPHIC) — 8KB
• form10-k_006.jpg (GRAPHIC) — 21KB
• ex23-1_001.jpg (GRAPHIC) — 7KB
• 0001493152-26-012801.txt ( ) — 7972KB
• celc-20251231.xsd (EX-101.SCH) — 54KB
• celc-20251231_cal.xml (EX-101.CAL) — 70KB
• celc-20251231_def.xml (EX-101.DEF) — 223KB
• celc-20251231_lab.xml (EX-101.LAB) — 517KB
• celc-20251231_pre.xml (EX-101.PRE) — 393KB
• form10-k_htm.xml (XML) — 933KB

Business

Business 7 Item 1A.

Risk Factors

Risk Factors 30 Item 1B. Unresolved Staff Comments 51 Item 1C. Cybersecurity 51 Item 2.

Properties

Properties 53 Item 3.

Legal Proceedings

Legal Proceedings 53 Item 4. Mine Safety Disclosures 53 PART II Item 5. Market for Registrant's Common Equity, Related Stockholder Matters and Issuer Purchases of Equity Securities 54 Item 6. Reserved 54 Item 7.

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

Management's Discussion and Analysis of Financial Condition and Results of Operations 54 Item 7A.

Quantitative and Qualitative Disclosures About Market Risk

Quantitative and Qualitative Disclosures About Market Risk 64 Item 8.

Financial Statements and Supplementary Data

Financial Statements and Supplementary Data 65 Item 9. Changes in and Disagreements with Accountants on Accounting and Financial Disclosure 91 Item 9A.

Controls and Procedures

Controls and Procedures 91 Item 9B. Other Information 91 Item 9C. Disclosure Regarding Foreign Jurisdictions that Prevent Inspections 91 PART III Item 10. Directors, Executive Officers and Corporate Governance 9 2 Item 11.

Executive Compensation

Executive Compensation 92 Item 12.

Security Ownership of Certain Beneficial Owners and Management and Related Stockholder Matters

Security Ownership of Certain Beneficial Owners and Management and Related Stockholder Matters 92 Item 13. Certain Relationships and Related Transactions, and Director Independence 92 Item 14. Principal Accountant Fees and Services 92 PART IV Item 15. Exhibits and Financial Statement Schedules 92 Item 16. Form 10-K Summary 92

Signatures

Signatures 93 2 SPECIAL NOTE REGARDING FORWARD-LOOKING STATEMENTS The Private Securities Litigation Reform Act of 1995 provides a "safe harbor" for forward-looking statements. This Annual Report on Form 10-K (this "Annual Report") contains forward-looking statements regarding us, our business prospects and our results of operations that are subject to certain risks and uncertainties that could cause our actual business, prospects and results of operations to differ materially from those that may be anticipated by such forward-looking statements. Factors that could cause or contribute to such differences include, but are not limited to, those described in Part I, Item 1A, "Risk Factors" and elsewhere in this Annual Report. Readers are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date of this Annual Report. We expressly disclaim any intent or obligation to update or revise any forward-looking statements, whether as a result of new information, future events or otherwise. Readers are urged to carefully review and consider the various disclosures made by us in this Annual Report and in our other reports filed with the Securities and Exchange Commission (the "SEC") that advise interested parties of the risks and uncertainties that may affect our business. All and expectations for our business, operations and financial performance and condition, are forward-looking statements. In some cases, you can identify forward-looking statements by the following words: "anticipate," "believe," "continue," "could," "estimate," "expect," "intend," "may," "might," "ongoing," "plan," "potential," "predict," "should," "target," "will," "would," or the negative of these terms or other comparable terminology, although not all forward-looking statements contain these words. Forward-looki

View Full Filing

View this 10-K filing on SEC EDGAR