What the changes say
- Celcuity added $338.8M in debt, including $201.3M in Senior Notes and $130M in Term Loans, ramping up commercial and financing risks.
What changed since the prior 10-K
New
- NewRisks Relating to Our Business
We have not yet commercialized a pharmaceutical product, and we may never generate revenue or profit
We have never commercialized a pharmaceutical product, have no revenue, and may never achieve profitability on our lead drug candidate, gedatolisib.
- NewRisks Relating to Our Business
Changes to trade policy, including new or increased tariffs and changing import and export regulations, could have a material adverse effect on our business, results of operations and financial condition
Changes in U.S. or international trade policies, tariffs, or trade restrictions could harm our financial condition.
- NewRisks Relating to Our Business
Our indebtedness and liabilities could limit the cash flow available for our operations, expose us to risks that could adversely affect our business, financial condition and results of operations and impair our ability to satisfy our debt obligations
We carry $338.8 million in total indebtedness as of December 31, 2025, which could limit cash flow and constrain future operations.
- NewRisks Relating to Our Business
We may be unable to raise the funds necessary to repurchase the Notes for cash following a fundamental change or to pay any cash amounts due upon maturity, and our other indebtedness may limit our ability to repurchase the Notes or to pay any cash amounts due upon their maturity
We may lack sufficient cash or financing to repurchase our 2.750% Senior Notes due 2031 upon a fundamental change or maturity.
- NewRisks Relating to Our Business
Provisions in the Indenture could delay or prevent an otherwise beneficial takeover of us
Indenture provisions related to our Senior Notes, such as mandatory cash repurchases upon a fundamental change, may deter third-party takeover attempts.
- NewRisks Related to Product Development and Product Regulation
Additionally, if the size of the FDA group dedicated to reviewing oncology-related submissions is reduced, further delays of our regulatory submissions may be encountered
Reductions in the size of the FDA oncology review group could cause further delays in our regulatory submissions.
Dropped
- DroppedRisks Relating to Our Business
We have a limited operating history and we may never generate revenue or profit
Limited operating history and unproven business plan.
- DroppedRisks Related to Our Product Strategy
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, our business will be materially harmed
- DroppedRisks Related to Product Development and Product Regulation
Our focus on the clinical development of gedatolisib has led us to minimize the Company’s activities to support development of CELsignia, which will significantly delay, or potentially forestall, further advancement of clinical development of CELsignia tests or finding appropriate pharmaceutical company partners
- DroppedRisks Related to Our Reliance on Third Parties
The pharmaceutical companies that we partner with for our CELsignia tests may not be successful in receiving regulatory approval for drug indications or may not commercialize their companion therapies for our expected companion diagnostic programs
- DroppedRisks Relating to Our Common Stock
Our Series A Preferred Stock has rights, preferences, and privileges that are not held by, and are preferential to, the rights of holders of our common stock
- DroppedRisks Relating to Our Common Stock
If securities or industry analysts do not publish research or reports about our business, or publish negative reports about our business, our stock price and trading volume could decline
- DroppedRisks Relating to Our Common Stock
We incur increased costs as a result of operating as a public company, and our management devotes substantial time to new compliance initiatives and corporate governance practices
Near-term revenue depends on commercializing gedatolisib.
- DroppedRisks Relating to Our Common Stock
We do not currently intend to pay dividends on our common stock, and, consequently, our stockholders’ ability to achieve a return on their investment will depend on appreciation in the price of our common stock
Reworded
- 75% rewrittenRisks Relating to Our Common Stock
Future sales of shares of our common stock, including by us and significant stockholders, could negatively affect our stock price
Updated common stock sales capacity under the Jefferies agreement to $400 million and added $201.3 million of convertible Senior Notes issued in August 2025.
- 54% rewrittenRisks Related to Our Reliance on Third Parties
Failure to comply with applicable U.S. data security and privacy regulations may increase our operational costs
Clarified that clinical operations are currently exempt from most privacy laws under HIPAA, but FDA approval of gedatolisib will trigger state privacy laws.
Was: Failure to comply with the HIPAA security and privacy regulations may increase our operational costs
- 51% rewrittenRisks Relating to Our Business
We are expanding our development and regulatory capabilities and implementing sales, marketing and distribution capabilities, and as a result, we may encounter difficulties in managing our growth, which could disrupt our operations
Shifted language from anticipating growth to actively experiencing significant growth in employees and operations for sales, marketing, and distribution.
Was: We expect to expand our development and regulatory capabilities and potentially implement sales, marketing and distribution capabilities, and as a result, we may encounter difficulties in managing our growth, which could disrupt our operations
- 45% rewrittenRisks Related to Our Reliance on Third Parties
We will also need to expend a considerable amount of resources complying with other federal, state and foreign laws and regulations. If we are unable to comply or have not complied with such laws, we could face substantial penalties or other adverse actions
Retained prior risk language regarding complex regulations without substantive textual changes.
- 44% rewrittenRisks Related to Intellectual Property
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
Specified Pfizer as the specific licensor under the Gedatolisib License Agreement instead of general third-party licensors.
Was: We depend on intellectual property licensed from third parties, including from Pfizer for our lead product candidate, and termination of this license could result in the loss of significant rights, which would harm our business
- 38% rewrittenRisks Related to Our Reliance on Third Parties
Performance issues or price increases by our shipping carriers could adversely affect our business, results of operations and financial condition, and harm our reputation and ability to provide our products on a timely basis
Updated shipping risk from safeguarding sample transport for CELsignia to protecting API and product transport for gedatolisib.
- 37% rewrittenRisks Related to Product Development and Product Regulation
Breakthrough Therapy Designation, Fast Track Designation, NDA submission via RTOR, and being awarded Priority Review from the FDA may not actually lead to a faster development or regulatory review or approval process
Abbreviated New Drug Application to NDA in reference to FDA regulatory review processes.
Was: Breakthrough Therapy Designation or Fast Track Designation from the FDA may not actually lead to a faster development or regulatory review or approval process
- 36% rewrittenRisks Related to Commercializing Our Products
Our business, operational and financial goals may not be attainable if the market opportunities for our products are smaller than we expect. Our internal research and third-party estimates may not accurately reflect the market opportunities for gedatolisib today or in the future
Added reliance on third-party publications and research for market sizing and cancer patient population estimates.
- 33% rewrittenRisks Related to Our Reliance on Third Parties
Our reliance on third parties to formulate, manufacture and distribute our drug product exposes us to risks that may delay the development, regulatory approval and commercialization of our drug product or result in higher product and operational costs
Was: Our reliance on third parties to formulate and manufacture our drug product will expose us to risks that may delay the development, regulatory approval and commercialization of our drug product or result in higher product costs
- 30% rewrittenRisks Related to Commercializing Our Products
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
Was: Even if our products achieve positive clinical trial results and 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
- 30% rewrittenRisks Related to Our Product Strategy
We were not involved in the early development of gedatolisib; therefore, we are dependent on third parties having accurately generated, collected, interpreted and reported data from certain preclinical and clinical trials of gedatolisib
- 30% rewrittenRisks Relating to Our Business
Product liability claims may damage our reputation and, if insurance proves inadequate, these claims may harm our business
- 26% rewrittenRisks Related to Commercializing Our Products
We may encounter difficulties in scaling production of, commercializing, marketing and distributing our products, including in hiring and retaining a qualified sales force
- 26% rewrittenRisks Related to Our Product Strategy
Interim, topline and preliminary data from our clinical studies that we announce or publish from time to time may change as more data become available and are subject to audit and verification procedures that could result in material changes in the final data
Was: Interim, topline and preliminary data from our clinical studies that we announce or publish from time to time may change as more data becomes available and are subject to audit and verification procedures that could result in material changes in the final data
- 24% rewrittenRisks Relating to Our Business
Our inability to raise additional capital on acceptable terms in the future may limit our ability to develop and commercialize our drug candidate, gedatolisib
- 22% rewrittenRisks Related to Our Product Strategy
We have not yet successfully completed any registrational clinical trials, and we may be unable to do so for any drug candidates we may develop
All 43 risk factors
Headings as the filing states them, in filing order.
Risks Relating to Our Business
- 01We have not yet commercialized a pharmaceutical product, and we may never generate revenue or profitNew
- 02Our inability to raise additional capital on acceptable terms in the future may limit our ability to develop and commercialize our drug candidate, gedatolisib24% rewritten
- 03Future financing activities could dilute the percentage ownership of our stockholders and could cause our stock price to fall or could result in operating or other restrictions
- 04We are dependent on our ability to attract and retain key personnel
- 05Product liability claims may damage our reputation and, if insurance proves inadequate, these claims may harm our business30% rewritten
- 06We are expanding our development and regulatory capabilities and implementing sales, marketing and distribution capabilities, and as a result, we may encounter difficulties in managing our growth, which could disrupt our operations51% rewritten
- 07Changes to trade policy, including new or increased tariffs and changing import and export regulations, could have a material adverse effect on our business, results of operations and financial conditionNew
- 08Our indebtedness and liabilities could limit the cash flow available for our operations, expose us to risks that could adversely affect our business, financial condition and results of operations and impair our ability to satisfy our debt obligationsNew
- 09We may be unable to raise the funds necessary to repurchase the Notes for cash following a fundamental change or to pay any cash amounts due upon maturity, and our other indebtedness may limit our ability to repurchase the Notes or to pay any cash amounts due upon their maturityNew
- 10Provisions in the Indenture could delay or prevent an otherwise beneficial takeover of usNew
Risks Related to Our Product Strategy
- 11We were not involved in the early development of gedatolisib; therefore, we are dependent on third parties having accurately generated, collected, interpreted and reported data from certain preclinical and clinical trials of gedatolisib30% rewritten
- 12We have not yet successfully completed any registrational clinical trials, and we may be unable to do so for any drug candidates we may develop22% rewritten
- 13The successful development of our products is highly uncertain
- 14If we encounter difficulties enrolling patients in any of our clinical trials, our clinical development activities could be delayed or otherwise adversely affected
- 15Interim, topline and preliminary data from our clinical studies that we announce or publish from time to time may change as more data become available and are subject to audit and verification procedures that could result in material changes in the final data26% rewritten
- 16Clinical development involves a lengthy and expensive process, with an uncertain outcome. We may incur additional costs or experience delays in completing, or ultimately be unable to complete, the development and commercialization of our product candidates
- 17We face significant competition, and our operating results will suffer if we fail to compete effectively
- 18If 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
- 19The majority of our employees and contractors work remotely. Remote work involves risks to our information technology systems and data, as individuals utilize network connections, computers and devices outside our premises or network, including working at home, while in transit and in public locations
- 20Artificial intelligence presents risks and challenges that can impact our business including by posing security risks to our confidential information, proprietary information and personal data
- 21Public health matters may materially and adversely impact our business, including ongoing clinical trials
Risks Related to Product Development and Product Regulation
- 22Additionally, if the size of the FDA group dedicated to reviewing oncology-related submissions is reduced, further delays of our regulatory submissions may be encounteredNew
- 23Breakthrough Therapy Designation, Fast Track Designation, NDA submission via RTOR, and being awarded Priority Review from the FDA may not actually lead to a faster development or regulatory review or approval process37% rewritten
- 24Obtaining and maintaining FDA approval of our product candidates in the U.S. does not mean that we will be successful in obtaining regulatory approval of our product candidates in other jurisdictions
Risks Related to Commercializing Our Products
- 25Even 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 success30% rewritten
- 26If our products do not achieve an adequate level of acceptance, we may never generate significant product revenues and we may not become profitable
- 27We may encounter difficulties in scaling production of, commercializing, marketing and distributing our products, including in hiring and retaining a qualified sales force26% rewritten
- 28Our business, operational and financial goals may not be attainable if the market opportunities for our products are smaller than we expect. Our internal research and third-party estimates may not accurately reflect the market opportunities for gedatolisib today or in the future36% rewritten
Risks Related to Intellectual Property
- 29We 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 business44% rewritten
- 30If disputes over intellectual property that we have licensed prevent or impair our ability to maintain our current licensing arrangements on acceptable terms, we may be unable to successfully develop and commercialize the affected product candidates
- 31If we fail to comply with our obligations under our patent license with Pfizer, we could lose license rights that are important to our business
- 32We may not be successful in obtaining or maintaining necessary rights to develop any future product candidates on acceptable terms
- 33If we are not able to prevent disclosure of our trade secrets and other proprietary information, the value of our products could be significantly diminished
- 34We may be subject to claims by employees claiming ownership of what we regard as our own intellectual property
- 35Third parties may initiate legal proceedings alleging that we are infringing their intellectual property rights, the outcome of which would be uncertain and could have a material adverse effect on the success of our business
- 36Any lawsuits relating to infringement of intellectual property rights necessary to defend ourselves or enforce our rights will be costly and time consuming and could be unsuccessful
Risks Related to Our Reliance on Third Parties
- 37Our reliance on third parties to formulate, manufacture and distribute our drug product exposes us to risks that may delay the development, regulatory approval and commercialization of our drug product or result in higher product and operational costs33% rewritten
- 38Performance issues or price increases by our shipping carriers could adversely affect our business, results of operations and financial condition, and harm our reputation and ability to provide our products on a timely basis38% rewritten
- 39Failure to comply with applicable U.S. data security and privacy regulations may increase our operational costs54% rewritten
- 40We will also need to expend a considerable amount of resources complying with other federal, state and foreign laws and regulations. If we are unable to comply or have not complied with such laws, we could face substantial penalties or other adverse actions45% rewritten
Risks Relating to Our Common Stock
- 41Provisions in our corporate charter documents and under Delaware law could make an acquisition of our company, which may be beneficial to our stockholders, more difficult and may prevent attempts by our stockholders to replace or remove our current management
- 42The price of our common stock may be volatile and fluctuate substantially, which could result in substantial losses for purchasers of our common stock or could subject us to securities litigation
- 43Future sales of shares of our common stock, including by us and significant stockholders, could negatively affect our stock price75% rewritten
Other Celcuity 10-Ks
- FY2024 10-K risk factors45 risks
Clinical-stage biotechnology company dependent on the success, clinical trials, and regulatory approval of its lead drug candidate, gedatolisib.
Filed Mar 31, 2025
About this page
The headings are the filing's own. The one-line readings and the overview are automated and can be wrong: read Item 1A of the 10-K for the exact wording.