Celldex Therapeutics

Property Location · Square Feet · Use · Lease Expiration Date

Hampton, New Jersey · 33,400 · Headquarters, Office and Laboratory · July 2027(1)

Fall River, Massachusetts · 36,300 · Manufacturing, Office and Laboratory · July 2027(2)

New Haven, Connecticut · 17,700 · Office and Laboratory · October 2026(3)

(1) · Lease includes two renewal options of two years.

(2) · Lease includes one renewal option of three years.

(3) · In September 2025, we signed a new lease in New Haven, Connecticut to which we will relocate our existing New Haven operations to in 2026. The lease covers approximately 40,400 square feet of office and laboratory space and is scheduled to commence in 2026. The initial lease term is 5.5 years with three renewal options of five years each.

• Our stockholders may be subject to substantial dilution if we elect to pay future milestone consideration to the former Kolltan stockholders in shares of common stock. If we elect to pay future milestone consideration in cash, we would likely need to raise additional capital.
• Our long-term success depends heavily on our ability to fund and complete the research and development activities and obtain regulatory approval for our program assets.
• Our drug candidates are subject to extensive regulatory scrutiny.
• Premarket review of our product candidates by the FDA and/or other regulatory authorities is a lengthy and uncertain process and approval may be delayed, limited or denied, any of which would adversely affect our ability to generate operating revenues.
• Disruptions at the U.S. FDA and other government agencies caused by funding shortages or otherwise could hinder their ability to hire and retain key leadership and other personnel, or otherwise review and process regulatory submissions in a timely manner, which could negatively impact our business.
• If our drug candidates do not pass required tests for safety and effectiveness, we will not be able to obtain regulatory approval and derive commercial revenue from them.
• Success in early clinical trials does not ensure that later clinical trials will be successful, and we cannot assure you that any of the clinical trials that we may conduct will demonstrate consistent or adequate efficacy and safety to obtain regulatory approval.
• Product testing is critical to the success of our drug candidates but subject to delay or cancellation if we have difficulty enrolling patients.
• We may have delays in commencing, enrolling and completing our clinical trials, and we may not complete them at all.
• If serious adverse or unacceptable side effects are identified during the development of our drug candidates, such events could prevent us from obtaining regulatory approval or achieving market acceptance of our drug candidates, and we may need to abandon or limit our development of some of our drug candidates.
• We may expend our resources to pursue a particular drug candidate or indication and forgo the opportunity to capitalize on drug candidates or indications that may ultimately be more profitable or for which there is a greater likelihood of success.
• We may be unable to manage multiple late-stage clinical trials for a variety of drug candidates simultaneously.
• Failure to successfully validate, develop and obtain regulatory approval for companion diagnostics for our drug candidates, if needed, could harm our drug development strategy and operational results.
• Any delay in obtaining regulatory approval would have an adverse impact on our ability to earn future revenues.
• We may enter into collaboration agreements for the licensing, development and ultimate commercialization of some of our drug candidates including, where appropriate, for our lead drug candidates. In such cases, we will depend greatly on our third-party collaborators to license, develop and commercialize such drug candidates, and they may not meet our expectations.
• We may face delays, difficulties or unanticipated costs in establishing and maintaining sales, marketing, market access, patient services and distribution capabilities or seeking a partnership for the commercialization of our drug candidates, even if regulatory approval is obtained.
• If our drug candidates for which we obtain regulatory approval do not achieve broad acceptance from physicians, patients and third-party payors, we may be unable to generate significant revenues, if any.
• Even if any of our drug candidates receive FDA approval, the terms of the approval may limit such drug’s commercial potential. Additionally, even after receipt of FDA approval, such drug would be subject to substantial, ongoing regulatory requirements.
• Reimbursement decisions by third-party payors may have an adverse effect on pricing and market acceptance of any of our drug candidates. If there is not sufficient reimbursement for our future drugs, it is less likely that such drugs will be widely used.
• Other factors could affect the demand for and sales and profitability of any drug candidates that we may commercialize in the future.
• Failure to obtain regulatory approvals in foreign jurisdictions will prevent us from marketing our products internationally.
• If we obtain approval to commercialize any approved products outside of the United States, a variety of risks associated with international operations could materially adversely affect our business.
• The biopharmaceutical industry is subject to extensive legislative and regulatory obligations and policies that may be subject to change, which could increase the difficulty and cost for us to progress our clinical programs, obtain marketing approval of and commercialize our product candidates and may affect the prices we may set.
• We rely on third parties to plan, conduct and monitor our clinical tests, and their failure to perform as required would interfere with our product development.
• We rely on CDMOs, some of whom are our single source manufacturers, over whom we have limited control. Should the cost, delivery and quality of clinical materials manufactured by us in our Fall River facility or supplied by CDMOs vary to our disadvantage, our business operations could suffer significant harm.
• Prior to approval of any drug candidate, the FDA must review and approve validation studies for both drug substance and drug product. The manufacturing processes for our drug candidates and device delivery systems utilize known technologies. We believe that the products we currently have under development can be scaled up to permit manufacture in commercial quantities. However, there can be no assurance that we will not encounter difficulties in scaling up the manufacturing processes. Significant scale-up of
• We may need to rely on third-party collaborators to develop and commercialize companion diagnostic tests for our drug candidates.
• Our reliance on third parties requires us to share our trade secrets, which increases the possibility that a competitor will discover them.
• We may engage in strategic transactions that could impact our liquidity, increase our expenses and present significant distractions to our management.
• We may expand our clinical development, regulatory and sales and marketing capabilities, and as a result, we may encounter difficulties in managing our growth, which could disrupt our operations.
• We may not be able to successfully integrate our existing technology or to modify our technologies to create new immunotherapeutic drugs.
• Our internal computer systems, or those of our CROs, CDMOs, or other contractors or consultants, may fail or suffer security breaches, which could result in a material disruption of our drug development programs.
• Our business requires us to use hazardous materials, which increases our exposure to dangerous and costly accidents.
• We face the risk of product liability claims, which could exceed our insurance coverage, and product recalls, each of which could deplete our cash resources.
• We license technology from other companies to develop products, and those companies could influence research and development or restrict our use of it. In addition, if we fail to comply with our obligations in our intellectual property licenses with third parties, we could lose license rights that are important to our business.
• Our ability to successfully develop and, if regulatory approval is obtained, commercialize our drug candidates may be materially adversely affected if we are unable to obtain and maintain effective intellectual property rights for our drug candidates and technologies.
• 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.
• We may be unable to protect the confidentiality of our trade secrets, thus harming our business and competitive position.
• We may become involved in lawsuits to protect or enforce our patents, which could be expensive, time- consuming and unsuccessful.
• 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 a material adverse effect on the success of our business.
• Third parties may assert that our employees or consultants have wrongfully used or disclosed confidential information or misappropriated trade secrets.
• We may not be able to obtain or maintain orphan drug designation or exclusivity for our product candidates.
• Any fast track designation or grant of priority review status by the FDA may not actually lead to a faster development or regulatory review or approval process, nor will it assure FDA approval of our product candidates. Additionally, our product candidates may treat indications that do not qualify for priority review vouchers.
• Any breakthrough therapy designation granted by the FDA for 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.
• If our processes and systems are not compliant with regulatory requirements, we could be subject to delays in submitting BLAs, NDAs or restrictions on marketing of drugs after they have been approved.
• We have conducted and are conducting clinical trials outside the United States and anticipate conducting additional clinical trials outside the United States, and the FDA may not accept data from such trials.
• Changes in product candidate manufacturing or formulation may result in additional costs or delay.
• Even if we receive regulatory approval for a drug candidate, we will be subject to ongoing regulatory obligations and continued regulatory review, which may result in significant additional expense and subject us to penalties if we fail to comply with applicable regulatory requirements.
• We may be subject, directly or indirectly, to federal and state health care fraud and abuse laws, false claims laws, transparency and pricing laws and health information privacy and security laws. If we are unable to comply, or have not fully complied, with such laws, we could face substantial penalties.
• Compliance with laws and regulations pertaining to the privacy and security of health information may be time consuming, difficult and costly, particularly in light of increased focus on privacy issues in countries around the world, including the U.S. and the EU.
• Our history of losses and uncertainty of future profitability make our common stock a highly speculative investment.
• Our share price has been and could remain volatile.
• Our ability to use our net operating loss carryforwards will be subject to limitation and, under certain circumstances, may be eliminated.
• If we fail to maintain an effective system of internal control over financial reporting, we may not be able to accurately report our financial results or prevent fraud. As a result, stockholders could lose confidence in our financial and other public reporting, which would harm our business and the trading price of our common stock.
• We have many competitors in our field, and they may develop technologies that make ours obsolete.
• We or the third parties upon whom we depend may be adversely affected by natural disasters or other unforeseen events and our business continuity and disaster recovery plans may not adequately protect us from a serious disaster.
• We face risks related to health epidemics and outbreaks, which could significantly disrupt our preclinical studies and clinical trials.
• Disruptions in the global economy and supply chains may have a material adverse effect on our business, financial condition and results of operations.
• We depend greatly on the intellectual capabilities and experience of our key executives and scientists, and the loss of any of them could affect our ability to develop our products.
• Our employees may engage in misconduct or other improper activities, including noncompliance with regulatory standards and requirements, which could have a material adverse effect on our business.
• We may not be able to maintain compliance with the Listing Rules of the NASDAQ Stock Exchange.
• The regulatory framework for AI Technologies is rapidly evolving and any failure or perceived failure by us or our employees, representatives, contractors, consultants, CROs, collaborators, or other third parties to comply with such requirements or adequately address privacy and security concerns, even if unfounded, could result in additional cost and liability to us, damage our reputation, and adversely affect our business and results of operations.