Celldex Therapeutics (CLDX) is:

• Like Moderna was before its COVID-19 vaccine success, but focused on developing novel treatments for cancer and inflammatory diseases instead of vaccines.
• An aspiring Vertex Pharmaceuticals, concentrating on developing cutting-edge immunotherapy treatments for cancer and autoimmune conditions.

• Barzolvolimab (CDX-0159): A monoclonal antibody targeting KIT, currently in clinical development for various mast cell-driven diseases such as chronic urticaria and indolent systemic mastocytosis.

Celldex Therapeutics (CLDX) - Major Customers

Celldex Therapeutics (CLDX) is a clinical-stage biopharmaceutical company focused on developing investigational therapies for difficult-to-treat diseases. As a company primarily engaged in research, development, and clinical trials of its drug candidates, it does not currently have commercial products on the market generating significant sales revenue from traditional "customers."

Therefore, Celldex Therapeutics does not have "major customers" in the sense of companies or individuals purchasing its commercial products.

Its business model at this stage primarily involves:

• Research and Development: Advancing its pipeline of drug candidates, such as barzolimab (CDX-0159).
• Clinical Trials: Conducting studies to evaluate the safety and efficacy of its therapies.
• Funding: Raising capital through equity offerings or potential strategic partnerships/collaborations to finance its development programs.

If and when Celldex Therapeutics successfully brings a product to market, its customers would typically be:

1. Hospitals and Clinics: Healthcare institutions that purchase and administer specialized therapies.
2. Specialty Pharmacies and Distributors: Companies responsible for the storage and distribution of complex biopharmaceutical products.
3. Government Healthcare Programs: Entities that purchase drugs for public health initiatives or national healthcare systems.

However, these are potential future customer categories, not current major customers for product sales.

Anthony S. Marucci, Founder, President, Chief Executive Officer and Director

Mr. Marucci was appointed President and Chief Executive Officer of Celldex in September 2008 and as a director in December 2008. He is also a co-founder of Celldex Therapeutics, which was founded in 1983. Prior to his CEO role, since May 2003, he held various positions at Celldex, including Vice President, Chief Financial Officer, Treasurer, and Secretary. Mr. Marucci served as Treasurer of Medarex, Inc. (now part of Bristol-Myers Squibb Co.) from December 1998 to March 2004, where he also held a series of senior financial positions. He was Interim President & Chief Executive Officer at AVANT Immunotherapeutics, Inc. in 2008. His background includes corporate finance, mergers and acquisitions, and strategic planning. He holds an M.B.A. from Columbia University and an M.H.L. from Brown University.

Sam Martin, Senior Vice President and Chief Financial Officer

Mr. Martin has served as Celldex Therapeutics' Senior Vice President and Chief Financial Officer since 2017.

Tibor Keler, Ph.D., Founder, Executive Vice President and Chief Scientific Officer

Dr. Keler is a co-founder of Celldex Therapeutics, established in 1983. He was appointed Executive Vice President and Chief Scientific Officer in 2014, having previously served as Senior Vice President of Research and Discovery at Celldex. From September 1993 to March 2004, Dr. Keler was Senior Director of Preclinical Development and Principal Scientist at Medarex (now part of Bristol-Myers Squibb Co.), where he was responsible for the preclinical development of several clinical product candidates, including ipilimumab. He has been instrumental in the development of Celldex's core technology and related products. Dr. Keler received his Ph.D. in Microbiology from the University of Pennsylvania.

Elizabeth Crowley, Senior Vice President, Chief Product Development Officer

Ms. Crowley joined Celldex in 2009 as Vice President, Clinical Development, and was subsequently promoted to Senior Vice President, Product Development, and then to Senior Vice President, Chief Product Development Officer. Before Celldex, she held several senior-level roles at CuraGen Corporation from 2005 to October 2009, including Vice President of Development Operations. She began her career at Bayer Corporation in 1992, where she held various leadership positions in clinical research and project management, concluding her tenure as Director of Global Study Audit Management. Ms. Crowley holds a B.S. in Chemistry from Boston College.

Diane C. Young, M.D., Senior Vice President and Chief Medical Officer

Dr. Young joined Celldex in July 2019 as Senior Vice President and Chief Medical Officer. Prior to Celldex, she served as Chief Medical Officer of GTx, Inc., a public biopharmaceutical company. She also spent 13 years at Novartis Oncology in senior leadership roles in global clinical development and medical affairs, where she directed clinical programs that led to successful regulatory approvals for multiple drugs, including EXJADE®, GLIVEC®, FEMARA®, AFINITOR®, RYDAPT®, JAKAVI® and FARIDAK®. Dr. Young is a board-certified medical oncologist with over 30 years of experience in the pharmaceutical industry.

Key Risks to Celldex Therapeutics (CLDX)

1. Clinical Trial Outcomes and Regulatory Approval: As a company focused on developing therapeutic antibodies, Celldex's future largely hinges on the successful completion of its clinical trials, particularly for its lead candidate, barzolvolimab. Negative results, unforeseen safety concerns, or delays in late-stage trials for indications like chronic spontaneous urticaria (CSU) or cold urticaria could severely impact the company's valuation and prospects. Furthermore, even with positive trial data, there is no guarantee of obtaining regulatory approval from agencies like the FDA, which can be a lengthy and rigorous process.
2. Financial Condition, Cash Burn, and Need for Additional Capital: Celldex is currently operating at a loss, with significant cash burn to fund its research and development and ongoing clinical trials. While the company has reported a strong cash position that is expected to support operations for several years, there is a risk of needing to raise additional capital through equity offerings or debt if key milestones are not met or if expenses outpace projections. Such capital raises could dilute the ownership of existing shareholders.
3. Competitive Dynamics: The therapeutic areas Celldex is targeting, such as immune disorders, are characterized by existing treatments and a pipeline of new drugs from competitors. The potential market share and pricing power of Celldex's product candidates, if approved, could be limited by established therapies (e.g., omalizumab for urticaria) and other novel oral or biologic drugs in development.

The primary clear emerging threat for Celldex Therapeutics revolves around intensifying competition in the therapeutic areas targeted by its lead candidate, Barzolvolimab (CDX-0159), particularly in Chronic Spontaneous Urticaria (CSU) and Prurigo Nodularis (PN).

Several well-funded pharmaceutical companies are developing or have already launched products that could significantly impact Barzolvolimab's market potential:

• Dupilumab (Dupixent) from Sanofi/Regeneron: This drug is already approved for Prurigo Nodularis, which is one of Barzolvolimab's target indications. Dupixent also has a strong established market presence in other related atopic diseases and is in development for CSU. Its existing market penetration and broad label could present a formidable challenge to Barzolvolimab's potential market share in both PN and CSU.
• Oral Bruton's Tyrosine Kinase (BTK) inhibitors (e.g., fenebrutinib from Roche/Genentech, remibrutinib from Novartis): Several oral BTK inhibitors are in late-stage clinical development for CSU. The convenience of an oral administration route, compared to Barzolvolimab's injectable delivery, could provide a significant competitive advantage and potentially limit Barzolvolimab's market adoption, even if efficacy profiles are similar.

Celldex Therapeutics (symbol: CLDX) is primarily focused on developing Barzolvolimab (CDX-0159), a humanized monoclonal antibody that targets the KIT receptor, for several mast cell-mediated diseases.

Here are the addressable markets for its main product indications:

• Chronic Spontaneous Urticaria (CSU): The global market for chronic spontaneous urticaria was valued at approximately USD 823.4 million in 2024 and is anticipated to reach USD 1,664.9 million by 2032. The market across the 7 major markets (US, EU4, UK, and Japan) was approximately USD 2.17 billion in 2023. The US market for CSU was approximately USD 1.19 billion in 2023.
• Chronic Inducible Urticaria (CIndU): The global chronic inducible urticaria market is projected to grow from USD 1.9 billion in 2024 to USD 4.6 billion in 2034.
• Eosinophilic Esophagitis (EoE): The global eosinophilic esophagitis market was valued at USD 366.2 million in 2024 and is projected to grow at a Compound Annual Growth Rate (CAGR) of 31.4% from 2025 to 2034. The US market for eosinophilic esophagitis is forecast to grow from $202 million in 2020 to $1.19 billion by 2030. (Note: Celldex recently terminated development for Barzolvolimab in EoE.)
• Atopic Dermatitis (AD): The global atopic dermatitis drugs market size was estimated at USD 17.64 billion in 2024 and is projected to reach USD 29.88 billion by 2030. The market across the top 7 markets (US, EU4, UK, and Japan) reached a value of USD 18,076.40 million in 2024 and is expected to reach USD 40,234.20 million by 2035.
• Prurigo Nodularis (PN): null

Share Issuance

• In June 2020, Celldex Therapeutics completed an underwritten public offering, issuing 15,384,614 shares of common stock at $9.75 per share, resulting in gross proceeds of approximately $150.0 million.
• In July 2021, the company closed an underwritten public offering of 6,845,238 shares of common stock at $42.00 per share, generating gross proceeds of approximately $287.5 million.
• In March 2024, Celldex completed an underwritten public offering of 9,798,000 shares of common stock at $47.00 per share, raising approximately $460.5 million in gross proceeds.

Inbound Investments

• In March 2020, Celldex Therapeutics received a $1.7 million milestone payment from Rockefeller University. This payment was related to an existing 2013 agreement following Gilead Sciences' licensing of an HIV antibody portfolio from Rockefeller University, for which Celldex had provided manufacturing and development services.
• Celldex's total revenue for 2024 was $3.0 million, primarily derived from collaborations.

Capital Expenditures

• Celldex Therapeutics reported capital expenditures of $2 million in 2020, $1 million in 2021, $2 million in 2022, $2 million in 2023, and $2 million in 2024.
• The company's projected capital expenditures are $3 million for 2025 and are expected to remain at $3 million annually through 2029.
• Capital expenditures primarily support the company's research and development activities and its efforts to advance its pipeline of therapeutic antibodies for inflammatory, allergic, autoimmune, and other diseases.