Celcuity Inc. Common StockCELC

Legal and litigation · Intellectual property disputes

Disputes may also arise between us and Pfizer regarding intellectual property subject to the Gedatolisib License Agreement, including the scope of rights granted under the license agreement and other interpretation-related issues, whether and the extent to which our product candidates and processes infringe on intellectual property of the licensor.

Industry regulation · Regulatory compliance and changes

If we are unable to obtain approval from the FDA or comparable foreign regulatory authorities to market our products for their intended use, we will not be able to generate revenue. For a new drug to be approved for marketing, the FDA and other regulatory authorities must determine that the drug is safe and effective.

Data and privacy · Regulatory investigations and penalties

If we (or a third party upon whom we rely) experience a security incident or are perceived to have experienced a security incident, we may face government enforcement actions (for example, investigations, fines, penalties, audits, and inspections) and additional reporting requirements and/or oversight.

Data and privacy · Data protection and privacy laws

Our CROs and clinical investigators involved in our clinical trials may collect, receive, store, process, use, generate, transfer, disclose, make accessible, protect, secure, dispose of, transmit and share personal data as defined in data protection laws outside the U.S. Accordingly, we are subject to numerous foreign privacy and security laws regulating the collection, use, safeguarding, transfer and other processing of personal data.

Stakeholder relations · Customer satisfaction and loyalty

Even if our products achieve requisite approvals, they may fail to achieve the degree of market acceptance by physicians, patients, third-party payors and others in the medical community necessary for commercial success. If the product candidates we develop do not achieve an adequate level of acceptance, we may not generate significant product revenues.

Corporate governance · Shareholder rights and activism

Provisions in the Notes and the Indenture could make a third-party attempt to acquire us more difficult or expensive. For example, if a takeover constitutes a fundamental change, then, subject to limited exceptions, Noteholders will have the right to require us to repurchase their Notes for cash.

Market position and competition · Pricing pressure and margin compression

Even if we obtain regulatory approval of drug products, the availability and price of our competitors' products could limit the demand and the price we are able to charge for our product candidates. We may not be able to implement our business plan if the acceptance of our product candidates is inhibited by price competition.

Market position and competition · Disruptive competitors and new market entrants

Smaller or early-stage companies may also prove to be significant competitors, particularly as they develop novel approaches to treating disease indications that gedatolisib is also focused on treating. Established pharmaceutical companies may also invest heavily to accelerate discovery and development of novel therapeutics.

Innovation and product development · Intellectual property protection and infringement

We depend on intellectual property licensed from Pfizer for our lead product candidate, and termination of this license could result in the loss of significant rights, which would materially and adversely impact our business. Key patents covering gedatolisib and any combination therapies using our product candidates are licensed from Pfizer pursuant to the Gedatolisib License Agreement.

Customer and revenue · Reimbursement and pricing pressure healthcare or insurance

Commercial success of any approved products will also depend in large part on the availability of insurance coverage and adequate reimbursement from third-party payors, including government payors such as the VA, Medicare and Medicaid programs. Government and private payors routinely seek to manage utilization and control costs.

Innovation and product development · Clinical trial and regulatory approval risks

Our near-term revenue prospects depend on the success of our initial drug product, gedatolisib. If we are unable to successfully complete clinical development of, obtain regulatory approval for, or commercialize, gedatolisib, or if we experience delays in doing so, including supply chain interruptions, our business will be materially and adversely impacted.

Cybersecurity and data protection · Data breaches and cyber attacks

If our information technology systems or data, or those of third parties upon which we rely, are or were compromised, we could face clinical trial delays; regulatory investigations or actions; litigation; fines and penalties; disruptions of our business operations; reputational harm; and other adverse consequences. Cyberattacks, malicious internet-based activity, online and offline fraud, and other similar activities threaten the confidentiality, integrity, and availability of our sensitive information.

Digital transformation and innovation · Artificial intelligence and automation

Artificial intelligence presents risks and challenges that can impact our business including by posing security risks to our confidential information, proprietary information and personal data. Our vendors may incorporate generative artificial intelligence tools into their offerings without disclosing this use to us, and the providers of these generative artificial intelligence tools may not meet existing or rapidly evolving regulatory or industry standards.

Capital structure and performance · Debt management and refinancing

As of December 31, 2025, we had $338.8 million aggregate principal amount of indebtedness for borrowed money, of which $130.0 million was secured indebtedness consisting of the Term Loans. Our indebtedness could have significant negative consequences for our security holders and our business by limiting our ability to obtain additional financing on acceptable terms or at all.

Credit and liquidity · Debt service and covenant compliance

The A&R Loan Agreement contains, and any future indebtedness that we may incur in the future may contain, financial and other restrictive covenants that limit our ability to operate our business, raise capital or make payments under our other indebtedness. If we fail to comply with these covenants or to make payments under our indebtedness when due, then we would be in default.

Supply chain and procurement · Transportation and logistics disruption

Performance issues or price increases by our shipping carriers could adversely affect our business, results of operations and financial condition. Expedited, reliable shipping is essential to our operations. Should our shipping carriers encounter delivery performance issues such as loss, damage or destruction of our API or product, such occurrences may damage our reputation.

Supply chain and procurement · Raw material availability and cost volatility

Tariffs or other trade restrictions may lead to continuing uncertainty and volatility in U.S. and global financial and economic conditions and commodity markets, declining consumer confidence, significant inflation, and diminished expectations for the economy. Such conditions could have a material adverse impact on our business, results of operations and financial position.

Core operations · Operational disruption and business continuity

Ransomware attacks also continue to increase in prevalence and severity and can lead to significant interruptions in our operations, ability to provide our services, loss of data and income, reputational harm, and diversion of funds.

Geopolitical and trade · Regulatory and policy uncertainty

Disruptions at the FDA and other government agencies from funding cuts, personnel losses, leadership changes, regulatory reform, government shutdowns and other developments could hinder our ability to obtain guidance from the FDA regarding our clinical development programs and develop and secure approval of our product candidates in a timely manner.

Natural and catastrophic events · Pandemic and public health crises

The outbreak of COVID-19 and government measures taken in response demonstrated that public health matters have a significant impact on the global economy. Future outbreaks or variants of COVID-19, or the emergence of other pandemics or public health disruptions, could materially and adversely impact our clinical trials, business, financial condition and results of operations.