What the changes say
- Federal net operating losses increased to $359.6 million alongside expanded R&D tax credit carryforwards of $18.8 million.
- New risks highlight reliance on third-party manufacturers handling high occupational exposure band molecules and artificial intelligence implementation.
- Tax law changes under the One Big Beautiful Bill Act create new compliance uncertainties.
What changed since the prior 10-K
New
- NewRisks related to the discovery and development of our product candidates
are a relatively new class of product candidates, any failures or adverse outcomes in preclinical or clinical testing seen by other developers in this class could materially impact the success of our programs. We may never succeed in developing marketable products
As a developer of targeted protein degraders, failures or adverse clinical outcomes by other companies in this relatively new class of products could harm our success.
- NewRisks related to the discovery and development of our product candidates
conform to the federal tax laws. In addition, at the state level, there may be periods during which the use of net operating losses is suspended or otherwise limited, which could accelerate or permanently increase state taxes owed
We held federal and state research and development tax credit carryforwards of $18.8 million and $9.2 million as of December 31, 2025, which could expire unused.
- NewRisks related to the discovery and development of our product candidates
Changes in tax laws could adversely affect our business and financial condition
The enactment of the One Big Beautiful Bill Act on July 4, 2025, introduced significant changes to U.S. federal tax law that could adversely affect our business.
- NewRisks related to dependence on third parties
possible sanctions, tariffs, trade restrictions and/or other foreign regulatory requirements, could serve to limit the third parties we could engage, increase the cost or reduce the supply of materials available to us, or otherwise adversely affect our business prospects, financial condition and results of operations
Certain molecules receive high occupational exposure bands restricting the number of qualified contract manufacturing organizations available to produce our clinical supplies.
- NewRisks related to dependence on third parties
additional CMOs for our product candidates, we may also be required to demonstrate analytical comparability and/or conduct additional bridging studies or trials, all of which would require additional time and expense
We maintain ongoing collaborations including the Roche Agreement, Merck KGaA Agreement, and the Betta Pharma License Agreement for CFT8919 in Greater China.
- NewRisks related to our intellectual property
threatened, it could dissuade companies from collaborating with us to license, develop or commercialize current or future product candidates
Challenges to our owned, co-owned, or licensed patents could result in loss of exclusivity or freedom to operate for our product candidates.
- NewRisks related to our intellectual property
Pharmaceutical companies are subject to intense review by the U.S. Federal Trade Commission and comparable agencies in other countries regarding how they conduct or settle patent litigation, and we may face similar scrutiny that could result in fines, penalties or loss of rights.
We face potential scrutiny from the U.S. Federal Trade Commission regarding patent litigation settlements and anti-competitive practices.
- NewRisks related to regulatory matters
maintain the benefits associated with Orphan Drug Designation, including the potential for supplemental market exclusivity
We received Orphan Drug Designation for cemsidomide in multiple myeloma in August 2021 and may seek similar designations for other candidates.
- NewRisks related to regulatory matters
experience a faster development or regulatory review or approval process. In addition, receiving accelerated approval does not assure the product’s accelerated approval will eventually be converted to a traditional approval
FDA requests for pediatric studies under Section 505A could require us to conduct pediatric trials to secure an additional six months of pediatric exclusivity.
- NewRisks related to regulatory matters
identify or engage alternate service providers. This could result in reduced demand for any product candidate we develop, additional pricing pressures, delayed or limited supply of materials needed for our research or development activities, or other adverse effects to our financial condition and business prospects
International price controls and healthcare cost-containment measures can significantly impact the profitability and pricing of our product candidates outside the United States.
- NewRisks related to regulatory matters
We use artificial intelligence throughout our business in our ongoing effort to be innovative and increase efficiency, but the challenges we may face in its implementation and use could adversely impact our business
We utilize artificial intelligence for degrader discovery and optimization, exposing us to evolving state and federal regulatory frameworks and operational risks.
- NewRisks related to our common stock
Future sales and issuances of our common stock or rights to purchase common stock and issuances of common stock upon the exercise of outstanding warrants would result in additional dilution of the percentage ownership of our stockholders and could cause our stock price to fall
Our 2024 ATM Program with TD Cowen allows us to issue up to $200.0 million of common stock, causing dilution to existing stockholders.
- NewRisks related to our common stock
exercise of the pre-funded warrants. If some or all of these Class A and B Warrants and pre-funded warrants are exercised, our stockholders could experience substantial dilution and such exercise may cause the market price of our stock to decline
- NewRisks related to our common stock
Our outstanding Class A Warrants and Class B Warrants may not be exercised, and we may therefore not receive any additional funds notwithstanding our issuance of these warrants
Dropped
- DroppedRisks related to dependence on third parties
We expect to rely on third parties to conduct our current and future clinical trials and those third parties may not perform satisfactorily, including by failing to meet deadlines for the completion of our clinical trials or failing to comply with regulatory requirements or our clinical protocols
- DroppedRisks related to dependence on third parties
We may form or seek collaborations or strategic alliances or enter into additional licensing arrangements in the future and we may not realize the benefits of those collaborations, alliances, or licensing arrangements
- DroppedRisks related to dependence on third parties
targets or indications to which our product candidates are directed, which may have an adverse impact on our business prospects, financial condition and results of operations
- DroppedRisks related to our intellectual property
Intellectual property litigation could cause us to spend substantial resources and distract our personnel from their normal responsibilities
- DroppedRisks related to regulatory matters
We may face potential liability under applicable privacy laws, in the United States as well as other jurisdictions, if we obtain identifiable patient health information from clinical trials sponsored by us
- DroppedRisks related to regulatory matters
violations of these regulations may be punishable by criminal and/or civil sanctions, and may result in exclusion from participation in federal and state programs
- DroppedRisks related to employee matters, managing growth, and operational matters
business may be materially adversely affected if legislative or administrative changes to immigration or visa laws and regulations impair our hiring processes and goals or projects involving personnel who are not U.S. citizens
- DroppedRisks related to our common stock
If we were to determine to raise additional capital in the future, you would suffer dilution of your investment
Reworded
- 86% rewrittenRisks related to regulatory matters
We may seek approval of our product candidates, where applicable, under the FDA’s accelerated approval pathway. This pathway may not lead to a faster development or regulatory review or approval process and it does not increase the likelihood that our product candidates will receive marketing approval
Updated to specifically name cemsidomide as our lead product candidate in the context of the FDA accelerated approval pathway.
- 85% rewrittenRisks related to our intellectual property
We may not be able to obtain patent term extension under the Drug Price Competition and Patent Term Restoration Act of 1984 in the United States and, as a result, our product candidates, if approved, may not have patent protection for a sufficient period
Added specific administrative failure reasons for potentially not obtaining patent term extensions under the Drug Price Competition and Patent Term Restoration Act.
- 80% rewrittenRisks related to the discovery and development of our product candidates
Our ability to use our net operating loss carryforwards and research and development tax credit carryforwards may be limited
Updated federal and state net operating loss carryforward figures to $359.6 million and $474.9 million gross as of December 31, 2025.
- 79% rewrittenRisks related to our intellectual property
Changes in patent laws or patent jurisprudence could diminish the value of our patents in general or increase third party challenges to our patents, thereby impairing our ability to protect our product candidates
Added the risk that third parties could file blocking patent applications ahead of us due to the Leahy-Smith Act first-inventor-to-file provisions.
- 79% rewrittenRisks related to our intellectual property
If we are unable to protect the confidentiality of our trade secrets, our business and competitive position would be harmed
Expanded trade secret protection disclosures to include specific risks regarding failed assignment agreements and inadequate legal remedies.
- 77% rewrittenRisks related to employee matters, managing growth, and operational matters
We are highly dependent on our key personnel and anticipate hiring new key personnel. If we are not successful in attracting and retaining highly qualified personnel, we may not be able to successfully implement our business strategy
Maintained the list of key executive officer roles dependent on retention without substantive changes to the core threat.
- 75% rewrittenRisks related to the discovery and development of our product candidates
Relative to companies that are more established than we are or that have a larger footprint than we do, we have relatively limited experience as a company in completing preclinical studies to enable the filing of INDs, submitting INDs or commencing, enrolling, and conducting clinical trials
Refined language regarding our limited company experience in conducting clinical trials and IND-enabling studies.
- 72% rewrittenRisks related to our intellectual property
We may need to license intellectual property from third parties and such licenses may not be available, or may not be available on commercially reasonable terms
Clarified that third-party intellectual property licenses may be needed for development, manufacture, or commercialization of product candidates.
Was: We may need to license intellectual property from third parties and licenses of this nature may not be available or may not be available on commercially reasonable terms
- 68% rewrittenRisks related to our intellectual property
Third parties may initiate legal proceedings alleging that we are infringing their intellectual property rights, the outcome of which would be uncertain and could have an adverse effect on the success of our business
- 68% rewrittenRisks related to dependence on third parties
Our current and anticipated future dependence upon others for the manufacture of our product candidates or products may adversely affect our future profit margins and our ability to commercialize any products that receive marketing approval on a timely and competitive basis
- 68% rewrittenRisks related to our intellectual property
We may become involved in lawsuits or other proceedings to protect or enforce our patents, the patents of our licensors or other intellectual property, or to defend against challenges, which could be expensive, time-consuming and unsuccessful
Was: We may become involved in lawsuits to protect or enforce our patents, the patents of our licensors or other intellectual property, which could be expensive, time-consuming and unsuccessful
- 67% rewrittenRisks related to our intellectual property
Obtaining and maintaining patent protection depends on compliance with various procedural, documentary, fee payment, and other requirements imposed by governmental patent offices, and the protection of our patents could be reduced or eliminated if we fail to comply with these requirements
- 60% rewrittenRisks related to our intellectual property
We may be subject to claims by third parties asserting that we, our employees, consultants or contractors have misappropriated third party’s intellectual property or claiming ownership of what we regard as our own intellectual property
Was: We may be subject to claims by third parties asserting that we, our employees, consultants or contractors have misappropriated the applicable third party’s intellectual property or claiming ownership of what we regard as our own intellectual property
- 60% rewrittenRisks related to regulatory matters
Enacted and future healthcare legislation may increase the difficulty and cost for us to progress our clinical programs and obtain marketing approval of and commercialize our product candidates and may affect the prices we may set
- 58% rewrittenRisks related to our intellectual property
We rely on a combination of patents, trade secrets and confidentiality and assignment agreements to protect our intellectual property and prevent others from exploiting our platform technologies, our pipeline drug product candidates, any future drug product candidates we may develop, and their manufacture and use
Was: We rely upon a combination of patents, trade secret protection and confidentiality agreements to protect our intellectual property and prevent others from exploiting our platform technologies, our pipeline drug product candidates, any future drug product candidates we may develop and their use or manufacture
- 53% rewrittenRisks related to our intellectual property
Weakening patent laws and enforcement by courts in the United States and changes in the legal landscape may impact our ability to protect our markets
Was: Weakening patent laws and enforcement by courts in the United States and foreign countries may impact our ability to protect our markets
- 49% rewrittenRisks related to regulatory matters
A Breakthrough Therapy designation by the FDA, even if granted for any of our product candidates, may not lead to a faster development or regulatory review or approval process, and it does not increase the likelihood that our product candidates will receive marketing approval
- 41% rewrittenRisks related to our intellectual property
We only have limited geographical protection with respect to certain of our patents and we may not be able to protect our intellectual property rights throughout the world
- 36% rewrittenRisks related to the commercialization of our product candidates
Even if we or, in the case of CFT8919, Betta Pharma, receive marketing approval of any of our product candidates, our products may become subject to unfavorable pricing regulations, third-party reimbursement practices, or healthcare reform initiatives, any of which would impact our business
- 34% rewrittenRisks related to our common stock
Business disruptions, including due to natural disasters, global conflicts or political unrest, and unstable market conditions and downturns in economic and market conditions may have serious adverse consequences on our business, financial condition and stock price
- 26% rewrittenRisks related to our financial position and need for additional capital
We will need substantial additional funding to pursue our business objectives and continue our operations. If we are unable to raise capital when needed, we may be required to delay, limit, reduce, or terminate our research or product development programs or future commercialization efforts
All 64 risk factors
Headings as the filing states them, in filing order.
Risks related to our financial position and need for additional capital
- 01We are a clinical-stage biopharmaceutical company and have incurred significant losses since our inception. We expect to incur losses over at least the next several years and may never achieve or maintain profitability
- 02Further, we expect to continue to incur additional costs associated with operating as a public company, including significant legal, accounting, insurance, investor relations, and other expenses
- 03We will need substantial additional funding to pursue our business objectives and continue our operations. If we are unable to raise capital when needed, we may be required to delay, limit, reduce, or terminate our research or product development programs or future commercialization efforts26% rewritten
- 04We remain early in the development lifecycle, which may make it difficult for you to evaluate the success of our business to date and assess our future viability
- 05Raising additional capital may cause dilution to our stockholders, restrict our operations or require us to relinquish rights to our technologies or product candidates
Risks related to the discovery and development of our product candidates
- 06Our approach to the discovery and development of product candidates based on our TORPEDO platform for targeted protein degradation is unproven, which makes it difficult to predict the time, cost of development, and likelihood of successfully developing any products
- 07Relative to companies that are more established than we are or that have a larger footprint than we do, we have relatively limited experience as a company in completing preclinical studies to enable the filing of INDs, submitting INDs or commencing, enrolling, and conducting clinical trials75% rewritten
- 08are a relatively new class of product candidates, any failures or adverse outcomes in preclinical or clinical testing seen by other developers in this class could materially impact the success of our programs. We may never succeed in developing marketable productsNew
- 09Drug development is a lengthy and expensive process with an uncertain outcome. We may incur unexpected costs or experience delays in completing, or ultimately be unable to complete, the development and commercialization of our product candidates
- 10Our ability to use our net operating loss carryforwards and research and development tax credit carryforwards may be limited80% rewritten
- 11conform to the federal tax laws. In addition, at the state level, there may be periods during which the use of net operating losses is suspended or otherwise limited, which could accelerate or permanently increase state taxes owedNew
- 12Changes in tax laws could adversely affect our business and financial conditionNew
- 13If serious adverse events, undesirable side effects or unexpected characteristics or results are identified during the development of any product candidates we may develop, we may need to modify, abandon, or limit our further clinical development of those product candidates
- 14If we experience delays or difficulties in the enrollment of patients in our clinical trials, our timelines for submitting applications for and receiving necessary marketing approvals could be delayed, or we may be prevented from obtaining marketing approvals altogether
- 15We may expend our limited resources to pursue a particular product candidate or indication and fail to capitalize on product candidates or indications that may be more profitable or for which there is a greater likelihood of success
- 16We may not be successful in our efforts to identify or discover additional potential product candidates
- 17If we do not achieve our projected development goals in the timeframes we announce and expect, the commercialization of our products may be delayed and, as a result, our stock price may decline
Risks related to dependence on third parties
- 18possible sanctions, tariffs, trade restrictions and/or other foreign regulatory requirements, could serve to limit the third parties we could engage, increase the cost or reduce the supply of materials available to us, or otherwise adversely affect our business prospects, financial condition and results of operationsNew
- 19Our current and anticipated future dependence upon others for the manufacture of our product candidates or products may adversely affect our future profit margins and our ability to commercialize any products that receive marketing approval on a timely and competitive basis68% rewritten
- 20additional CMOs for our product candidates, we may also be required to demonstrate analytical comparability and/or conduct additional bridging studies or trials, all of which would require additional time and expenseNew
Risks related to the commercialization of our product candidates
- 21Even if any of our product candidates receives marketing approval, it 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
- 22As a company, we currently have no marketing and sales organization and no experience in marketing products. If we are unable to establish marketing and sales capabilities or enter into agreements with third parties to market and sell our product candidates, if approved, we may not be able to generate product revenue
- 23There can be no assurance that we will be able to develop in-house sales and distribution capabilities or establish or maintain relationships with third-party collaborators to commercialize any product in the United States or overseas
- 24Even if we or, in the case of CFT8919, Betta Pharma, receive marketing approval of any of our product candidates, our products may become subject to unfavorable pricing regulations, third-party reimbursement practices, or healthcare reform initiatives, any of which would impact our business36% rewritten
- 25Product liability lawsuits against us could cause us to incur substantial liabilities and to limit commercialization of any products that we may develop
Risks related to our intellectual property
- 26We rely on a combination of patents, trade secrets and confidentiality and assignment agreements to protect our intellectual property and prevent others from exploiting our platform technologies, our pipeline drug product candidates, any future drug product candidates we may develop, and their manufacture and use58% rewritten
- 27threatened, it could dissuade companies from collaborating with us to license, develop or commercialize current or future product candidatesNew
- 28Changes in patent laws or patent jurisprudence could diminish the value of our patents in general or increase third party challenges to our patents, thereby impairing our ability to protect our product candidates79% rewritten
- 29We may become involved in lawsuits or other proceedings to protect or enforce our patents, the patents of our licensors or other intellectual property, or to defend against challenges, which could be expensive, time-consuming and unsuccessful68% rewritten
- 30We may need to license intellectual property from third parties and such licenses may not be available, or may not be available on commercially reasonable terms72% rewritten
- 31Third parties may initiate legal proceedings alleging that we are infringing their intellectual property rights, the outcome of which would be uncertain and could have an adverse effect on the success of our business68% rewritten
- 32Pharmaceutical companies are subject to intense review by the U.S. Federal Trade Commission and comparable agencies in other countries regarding how they conduct or settle patent litigation, and we may face similar scrutiny that could result in fines, penalties or loss of rights.New
- 33We may not be able to obtain patent term extension under the Drug Price Competition and Patent Term Restoration Act of 1984 in the United States and, as a result, our product candidates, if approved, may not have patent protection for a sufficient period85% rewritten
- 34Weakening patent laws and enforcement by courts in the United States and changes in the legal landscape may impact our ability to protect our markets53% rewritten
- 35We may be subject to claims by third parties asserting that we, our employees, consultants or contractors have misappropriated third party’s intellectual property or claiming ownership of what we regard as our own intellectual property60% rewritten
- 36Obtaining and maintaining patent protection depends on compliance with various procedural, documentary, fee payment, and other requirements imposed by governmental patent offices, and the protection of our patents could be reduced or eliminated if we fail to comply with these requirements67% rewritten
- 37If we are unable to protect the confidentiality of our trade secrets, our business and competitive position would be harmed79% rewritten
- 38We only have limited geographical protection with respect to certain of our patents and we may not be able to protect our intellectual property rights throughout the world41% rewritten
Risks related to regulatory matters
- 39Receiving regulatory approval from the FDA and foreign regulatory authorities is lengthy, time-consuming and inherently unpredictable and, if we are ultimately unable to obtain marketing approval for our product candidates, our business will be substantially harmed
- 40In order to market any products in any particular jurisdiction, we must establish and comply with numerous and varying regulatory requirements on a country-by-country basis regarding safety and efficacy
- 41A Breakthrough Therapy designation by the FDA, even if granted for any of our product candidates, may not lead to a faster development or regulatory review or approval process, and it does not increase the likelihood that our product candidates will receive marketing approval49% rewritten
- 42maintain the benefits associated with Orphan Drug Designation, including the potential for supplemental market exclusivityNew
- 43We may seek approval of our product candidates, where applicable, under the FDA’s accelerated approval pathway. This pathway may not lead to a faster development or regulatory review or approval process and it does not increase the likelihood that our product candidates will receive marketing approval86% rewritten
- 44experience a faster development or regulatory review or approval process. In addition, receiving accelerated approval does not assure the product’s accelerated approval will eventually be converted to a traditional approvalNew
- 45We cannot be sure that coverage and reimbursement will be available for or accurately estimate the potential revenue from our product candidates or assure that coverage and reimbursement will be available for any product that we may develop
- 46Enacted and future healthcare legislation may increase the difficulty and cost for us to progress our clinical programs and obtain marketing approval of and commercialize our product candidates and may affect the prices we may set60% rewritten
- 47identify or engage alternate service providers. This could result in reduced demand for any product candidate we develop, additional pricing pressures, delayed or limited supply of materials needed for our research or development activities, or other adverse effects to our financial condition and business prospectsNew
- 48If we or our third-party manufacturers and suppliers fail to comply with environmental, health and safety laws and regulations, we could become subject to fines or penalties or incur costs that could have an adverse effect on the success of our business
- 49We use artificial intelligence throughout our business in our ongoing effort to be innovative and increase efficiency, but the challenges we may face in its implementation and use could adversely impact our businessNew
Risks related to employee matters, managing growth, and operational matters
- 50We are highly dependent on our key personnel and anticipate hiring new key personnel. If we are not successful in attracting and retaining highly qualified personnel, we may not be able to successfully implement our business strategy77% rewritten
- 51Our employees, independent contractors, vendors, principal investigators, CROs, and consultants may engage in misconduct or other improper activities, including non-compliance with regulatory standards and requirements, and insider trading laws
Risks related to our common stock
- 52Future sales and issuances of our common stock or rights to purchase common stock and issuances of common stock upon the exercise of outstanding warrants would result in additional dilution of the percentage ownership of our stockholders and could cause our stock price to fallNew
- 53exercise of the pre-funded warrants. If some or all of these Class A and B Warrants and pre-funded warrants are exercised, our stockholders could experience substantial dilution and such exercise may cause the market price of our stock to declineNew
- 54Our outstanding Class A Warrants and Class B Warrants may not be exercised, and we may therefore not receive any additional funds notwithstanding our issuance of these warrantsNew
- 55Currently, our common stock is listed on the Nasdaq Global Select Market. However, there may not be enough liquidity in that market to enable you to sell your shares of our common stock
- 56If securities or industry analysts do not publish or cease publishing research or reports about our business, or if they issue an adverse or misleading opinion regarding our stock, our stock price and trading volume could decline
- 57The price of our common stock may be volatile and fluctuate substantially, which could result in substantial losses for purchasers of our common stock
- 58We have broad discretion in the use of the capital we have raised and may not use our capital effectively
- 59Our executive officers, directors, and principal stockholders will have the ability to control or significantly influence matters submitted to stockholders for approval
- 60Anti-takeover provisions under our charter documents and Delaware law could delay or prevent a change of control, which could limit the market price of our common stock and may prevent or frustrate attempts by our stockholders to replace or remove our current management
- 61We will continue to incur additional costs as a result of operating as a public company and our management will be required to devote substantial time to compliance initiatives and corporate governance practices
- 62Our amended and restated by-laws designate specific courts as the exclusive forum for certain litigation that may be initiated by our stockholders, which could limit our stockholders’ ability to obtain a favorable judicial forum for disputes with us
- 63Because we do not anticipate paying any cash dividends on our capital stock in the foreseeable future, capital appreciation, if any, will be your sole source of gain
- 64Business disruptions, including due to natural disasters, global conflicts or political unrest, and unstable market conditions and downturns in economic and market conditions may have serious adverse consequences on our business, financial condition and stock price34% rewritten
Other C4 Therapeutics 10-Ks
- FY2024 10-K risk factors58 risks
C4 Therapeutics faces ongoing losses, accumulating a deficit of $633.7 million through December 31, 2024.
Filed Feb 27, 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.