CLDX

Find winning stocks in any market cycle. Join 7 million investors using Simply Wall St's investing ideas for FREE. Celldex Therapeutics (CLDX) released its second quarter 2026 results on 6 August, reporting very limited revenue and a wider net loss. This places the stock’s recent strength in sharper focus for investors. See our latest analysis for Celldex Therapeutics. Celldex Therapeutics shares have climbed strongly over the past year, with a year to date share price return of 54.42% and a 1 year total shareholder return of 101.89%. The recent 90 day share price gain of 29.21% suggests momentum has been building into the latest earnings update. If Celldex Therapeutics has sharpened your focus on higher growth healthcare ideas, it could be worth scanning a wider field of specialist drug developers and related names through our healthcare AI stocks screener, starting with the 43 healthcare AI stocks. After a sharp move in Celldex Therapeutics on very limited current revenue and a sizeable loss, the spread between the share price and analyst and intrinsic estimates raises a simple point: Where does fair value really sit now? On Simply Wall St's numbers, Celldex Therapeutics trades on a price-to-book ratio of 4.6x, which sits alongside a last close of $41.71 and points to a rich valuation against assets on the balance sheet. The P/B ratio compares the market value of the equity to its book value. It is a quick way to see how much investors are paying relative to the company’s net assets. For a loss making biotech such as Celldex Therapeutics, this type of metric often reflects expectations about future trial progress and eventual commercialisation rather than current earnings. In this case, the 4.6x P/B multiple is described as expensive both relative to the broader US Biotechs industry average of 2.5x and to a peer group average of 4.4x. That signals the market is assigning a premium over sector assets that already carry high future growth expectations, which leaves less room on this metric for disappointment if the story does not progress as hoped. Compared with the industry, Celldex Therapeutics is priced at almost double the typical biotech P/B level, and even stands above its closest peer group on this yardstick. The valuation could move closer to peer or industry levels if sentiment changes, so investors often watch this gap as a guide to how much optimism is embedded in the current share price. See what the numbers say about this price — find out in our valuation breakdown. Result: Price-to-book of 4.6x (OVERVALUED) However, Celldex Therapeutics still faces key risks, including ongoing clinical trial uncertainty and a current net loss of $300.549 million, which could reshape investor expectations. Find out about the key risks to this Celldex Therapeutics narrative. The picture changes when using the SWS DCF model. On these numbers, Celldex Therapeutics at $41.71 is trading below an estimated future cash flow value of $96.10, which points to a very large implied discount. If book value looks stretched, why is the cash flow view so different? Look into how the SWS DCF model arrives at its fair value. Simply Wall St performs a discounted cash flow (DCF) on every stock in the world every day (check out Celldex Therapeutics for example). We show the entire calculation in full. You can track the result in your watchlist or portfolio and be alerted when this changes, or use our stock screener to discover 52 high quality undervalued stocks. If you save a screener we even alert you when new companies match - so you never miss a potential opportunity. With mixed signals across Celldex Therapeutics and some strong opinions in both directions, it makes sense to move quickly and test the data yourself. To see the full balance between upside potential and the issues that worry investors, start by reviewing the 2 key rewards and 3 important warning signs. If Celldex Therapeutics has sharpened your interest, do not stop here. Use the Simply Wall St screener to quickly surface fresh opportunities that match your style. Target stability and income potential by reviewing companies in the 8 dividend fortresses that could suit a more income focused portfolio. Spot potential value opportunities early by scanning the screener containing 21 high quality undiscovered gems before they attract wider attention. Prioritise resilience and sleep easier at night by starting with companies in the 83 resilient stocks with low risk scores that score well on overall risk. This article by Simply Wall St is general in nature. We provide commentary based on historical data and analyst forecasts only using an unbiased methodology and our articles are not intended to be financial advice. It does not constitute a recommendation to buy or sell any stock, and does not take account of your objectives, or your financial situation. We aim to bring you long-term focused analysis driven by fundamental data. Note that our analysis may not factor in the latest price-sensitive company announcements or qualitative material. Simply Wall St has no position in any stocks mentioned. Companies discussed in this article include CLDX. Have feedback on this article? Concerned about the content? Get in touch with us directly. Alternatively, email [email protected]

Barzolvolimab Phase 3 chronic spontaneous urticaria studies (EMBARQ-CSU 1 and 2) ongoing, topline data expected in Sept/Oct 2026; BLA submission planned for 2027 Phase 3 barzolvolimab cold urticaria and symptomatic dermographism study (EMBARQ-ColdU and -SD) actively enrolling; Phase 2 topline data in AD expected in late 2026 Positive results from Phase 1 trial of bispecific CDX-622 showed rapid, profound, dose-dependent reductions in serum tryptase and CDX-622 was well tolerated; Phase 1 CDX-622 proof of mechanism study in asthma ongoing HAMPTON, N.J., Aug. 06, 2026 (GLOBE NEWSWIRE) -- Celldex (NASDAQ:CLDX) today reported financial results for the second quarter ended June 30, 2026 and provided a corporate update. “We are leaders in mast cell science with a pipeline of programs that have the potential to dramatically shift treatment paradigms for patients,” said Anthony Marucci, Co-founder, President and Chief Executive Officer at Celldex. “Barzolvolimab, followed by our first bispecific candidate CDX-622, are a powerful portfolio combination targeting inflammatory diseases where mast cells are implicated, with the goal of ultimately bringing our leading science to additional patient populations that could benefit from our medicines. We are looking forward to sharing the topline results from our two Phase 3 trials of barzolvolimab in the early fall and are actively driving towards potential commercialization.” Recent Program Highlights Barzolvolimab - KIT Inhibitor Program Barzolvolimab is a humanized monoclonal antibody with a novel mechanism of action that targets mast cells by binding with high specificity to a unique part of the KIT receptor and potently inhibiting its activity. The KIT receptor is abundantly expressed by mast cells and critical for their function and survival. Mast cells are drivers of inflammatory responses such as hypersensitivity and allergic reactions and, in certain inflammatory diseases, such as chronic urticarias, mast cell activation plays a central role in the onset and progression of the disease. Chronic Urticarias Enrollment was completed six months ahead of guidance in the global Phase 3 program in chronic spontaneous urticaria (CSU), demonstrating strong interest in barzolvolimab. The Phase 3 program consists of two trials—EMBARQ-CSU1 and EMBARQ-CSU2. 1,939 patients were enrolled—the largest program conducted in antihistamine refractory CSU, including patients with advanced therapy experienced/refractory CSU. The studies included 43 countries and over 500 sites. EMBARQ-CSU1 and EMBARQ-CSU2 are designed to establish the efficacy and safety of barzolvolimab in adult patients with CSU who remain symptomatic despite H1 antihistamine treatment and also include patients who remain symptomatic after treatment with advanced therapies. Topline data are anticipated in September/October 2026, supporting a planned BLA filing in 2027. In December 2025, Celldex initiated a global Phase 3 study in cold urticaria (ColdU) and symptomatic dermographism (SD)—EMBARQ-ColdU and -SD. Barzolvolimab is the first drug in development to demonstrate clinical benefit in patients with ColdU and SD in a large, randomized, placebo-controlled study. In the Phase 2 study, all primary and secondary endpoints were met with high statistical significance at 12 weeks and sustained through the end of the treatment period (20 weeks). In June 2026, Celldex presented long-term barzolvolimab results that demonstrated sustained off-treatment improvement in patients with CSU at the European Academy of Allergy and Clinical Immunology (EAACI) Annual Meeting. Treatment with barzolvolimab resulted in rapid, significant, and durable improvements in angioedema patients with moderate to severe CSU. Seven months after the completion of dosing (Week 76), up to 64% of patients treated with barzolvolimab who had angioedema at baseline remained angioedema-free. Results support the potential of barzolvolimab to shift treatment goals from symptom control to disease modification. Atopic Dermatitis and Prurigo Nodularis Enrollment is complete in the Phase 2 study in atopic dermatitis (AD). This randomized, double-blind, placebo-controlled, parallel group study is evaluating the efficacy and safety profile of barzolvolimab in patients with moderate to severe AD. Topline data from this study are expected to be presented in late 2026. Topline data from the Phase 2 study in prurigo nodularis (PN) were presented in July 2026 and demonstrated that the trial did not meet primary or key secondary endpoints. Barzolvolimab was well-tolerated and demonstrated a favorable safety profile consistent with prior studies. Rapid and profound suppression of circulating tryptase indicative of systemic mast cell depletion was observed. These data suggest that mast cells may not be the key pathogenic driver in PN. Based on these results, Celldex is discontinuing the Phase 2 PN study. Novel Bispecific Antibody Platform CDX-622 – Bispecific SCF & TSLP CDX-622 is a uniquely engineered novel bispecific antibody that targets soluble SCF and the alarmin thymic stromal lymphopoietin (TSLP), two critical pathways that may contribute to the pathology of several allergic and inflammatory disorders with significant unmet medical need. Combined neutralization of SCF and TSLP with CDX-622 is expected to simultaneously reduce tissue mast cells and inhibit Type 2 inflammatory responses, allowing for a complementary dual mechanism approach that may overcome the heterogeneity inherent in the pathophysiology of many inflammatory disorders. CDX-622 has been engineered to disable effector function (AQQ) and enhance half-life (YTE). In June 2026, first-in-human data were presented that demonstrated that neutralizing the soluble form of SCF can selectively inhibit KIT signaling in mast cells. This approach provides a validated anchor mechanism that enables the development of diverse bispecific antibody candidates where a dual mechanism approach may overcome the heterogeneity inherent in the pathophysiology of many inflammatory disorders. Additionally in June, Celldex presented a study in non-human primates at the European Mast Cell and Basophil Research Network (EMBRN) that showed that targeting soluble SCF effectively depleted mast cells in a manner similar to targeting membrane SCF, but without measurable effect on spermatogenesis or melanogenesis in non-human primates. In January 2026, an open-label, single-dose Phase 1 proof of mechanism (POM) study was initiated to assess the safety, pharmacodynamics, and pharmacokinetics of CDX-622 in adults with mild to moderate asthma. Based on recently reported data, the Company is advancing expansion into additional indications with CDX-622, including allergic rhinitis and food allergy. Second Quarter 2026 Financial Highlights and 2026 Guidance Cash Position: Cash, cash equivalents and marketable securities as of June 30, 2026 were $717.6 million compared to $451.5 million as of March 31, 2026. The increase was primarily driven by net proceeds of $323.8 million from our April 2026 underwritten public offering, partially offset by second quarter cash used in operating activities of $57.4 million. At June 30, 2026, Celldex had 78.5 million shares outstanding. Revenues: No material revenue was recognized in the second quarter of 2026 or the six months ended June 30, 2026, compared to $0.7 million and $1.4 million for the comparable periods in 2025, respectively. The decrease in revenue was primarily due to a decrease in services performed under our manufacturing and research and development agreements with Rockefeller University. R&D Expenses: Research and development (R&D) expenses were $67.5 million in the second quarter of 2026 and $140.5 million for the six months ended June 30, 2026, compared to $54.2 million and $106.8 million for the comparable periods in 2025. The increase in R&D expenses was primarily due to an increase in barzolvolimab clinical trial and contract manufacturing expenses and an increase in employee headcount. G&A Expenses: General and administrative (G&A) expenses were $13.1 million in the second quarter of 2026 and $24.6 million for the six months ended June 30, 2026, compared to $10.4 million and $21.2 million for the comparable periods in 2025. The increase in G&A expenses was primarily due to an increase in barzolvolimab commercial planning expenses. Net Loss: Net loss was $73.5 million, or ($0.94) per share, for the second quarter of 2026, and $152.2 million, or ($2.11) per share, for the six months ended June 30, 2026, compared to a net loss of $56.6 million, or ($0.85) per share, for the second quarter of 2025, and $110.4 million, or ($1.66) per share, for the six months ended June 30, 2025. Financial Guidance: Celldex believes that the cash, cash equivalents and marketable securities at June 30, 2026 are sufficient to meet estimated working capital requirements and fund current planned operations through 2028. About CelldexCelldex is pioneering new horizons in immunology to deliver life-changing therapies. We are relentless in our pursuit of novel antibody-based treatments that engage the human immune system and directly affect critical pathways to improve the lives of patients with allergic, inflammatory and autoimmune disorders. Visit www.celldex.com. Forward Looking StatementThis release contains "forward-looking statements" made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. These statements are typically preceded by words such as "believes," "expects," "anticipates," "intends," "will," "may," "should," or similar expressions. These forward-looking statements reflect management's current knowledge, assumptions, judgment and expectations regarding future performance or events. Although management believes that the expectations reflected in such statements are reasonable, they give no assurance that such expectations will prove to be correct or that those goals will be achieved, and you should be aware that actual results could differ materially from those contained in the forward-looking statements. Forward-looking statements are subject to a number of risks and uncertainties, including, but not limited to, our ability to successfully complete research and further development and commercialization of Company drug candidates, including barzolvolimab (also referred to as CDX-0159) and CDX-622, in current or future indications; the uncertainties inherent in clinical testing and accruing patients for clinical trials; our limited experience in bringing programs through Phase 3 clinical trials; our ability to manage and successfully complete multiple clinical trials and the research and development efforts for our multiple products at varying stages of development; the availability, cost, delivery and quality of clinical materials produced by our own manufacturing facility or supplied by contract manufacturers, who may be our sole source of supply; the timing, cost and uncertainty of obtaining regulatory approvals; the failure of the market for the Company's programs to continue to develop; our ability to protect the Company's intellectual property; the loss of any executive officers or key personnel or consultants; competition; changes in the regulatory landscape or the imposition of regulations that affect the Company's products; our ability to continue to obtain capital to meet our long-term liquidity needs on acceptable terms, or at all, including the additional capital which will be necessary to complete the clinical trials that we have initiated or plan to initiate; and other factors listed under "Risk Factors" in our annual report on Form 10-K and quarterly reports on Form 10-Q. All forward-looking statements are expressly qualified in their entirety by this cautionary notice. You are cautioned not to place undue reliance on any forward-looking statements, which speak only as of the date of this release. We have no obligation, and expressly disclaim any obligation, to update, revise or correct any of the forward-looking statements, whether as a result of new information, future events or otherwise. Company ContactsSarah CavanaughSenior Vice President, Corporate Affairs & Administration(508) [email protected] Elizabeth HigginsExecutive Director, Investor Relations & Corporate Communications(857) [email protected]

Study did not meet key efficacy objectives Favorable safety profile consistent with prior studies, including with new 450mg loading dose and up to 300mgQ4W regimen Profound systemic mast cell depletion, as evidenced by significant reduction in serum tryptase, observed Phase 3 CSU topline data expected in Sept/Oct 2026; Phase 3 SD and ColdU Enrollment On Track; Phase 2 topline data in AD in late 2026 Company to host webcast today at 4:30 pm ET HAMPTON, N.J., July 21, 2026 (GLOBE NEWSWIRE) -- Celldex (NASDAQ:CLDX) today reported topline results from the Company’s Phase 2 study of barzolvolimab delivered subcutaneously in prurigo nodularis (PN), a chronic skin disease that causes hard, intensely itchy lumps/nodules to form on the skin. The primary endpoint of the study, the proportion of patients who achieve a four point or greater improvement in WI-NRS (Worst Itch Numeric Rating Scale) from baseline to Week 12, and key secondary endpoints were not met. Barzolvolimab, a humanized monoclonal antibody with a completely novel mechanism of action that uniquely targets the mast cell, is being studied across multiple indications. Profound mast cell depletion as evidenced by significant reduction in serum tryptase was observed and did not result in improvement in itch or skin lesions in patients with PN compared to placebo, indicating mast cells may not be a key pathogenic driver of symptoms in PN. Based on these results, Celldex is discontinuing the Phase 2 study in PN. Consistent with previously reported studies, barzolvolimab demonstrated a favorable safety and tolerability profile. “At Celldex, we are leading important science in the exploration of mast cell biology, with the goal of ultimately delivering life-changing therapies for patients,” said Anthony Marucci, Co-founder, President and Chief Executive Officer of Celldex. “Barzolvolimab profoundly depletes mast cells with best-in-disease data observed in three indications to date; chronic spontaneous urticaria, symptomatic dermographism, and cold urticaria, all of which demonstrated unequivocal Phase 2 proof-of-concept data and progressed quickly to Phase 3. It is disappointing that this study did not confirm the promising signal we observed in the intravenous Phase 1b trial, and that the robust tryptase reductions seen in this study did not result in improvement of PN symptoms for patients who greatly need effective treatments. We remain focused on driving mast cell category creation and delivering on barzolvolimab’s promise for patients with allergic, inflammatory, and autoimmune diseases, and look forward to sharing topline data from our Phase 3 CSU trials early this fall.” Summary of Key Findings The study did not meet primary or key secondary endpoints at Week 12 at either dose level evaluated. Barzolvolimab was well tolerated. Loading dose (450mg) followed by Q4W dosing (150 or 300mg) demonstrated favorable safety profile consistent with prior studies. Rapid and profound suppression of circulating tryptase, indicative of systemic mast cell depletion, was observed. The addition of the 450mg loading dose led to early, profound tryptase reduction that was sustained over the duration of the treatment period. This Phase 2 randomized, double-blind, placebo-controlled, parallel group study evaluated barzolvolimab compared to placebo in patients with moderate to severe PN who had inadequate response to prescription topical medications, or for whom topical medications were medically inadvisable. 140 patients were randomly assigned to receive barzolvolimab 150mgQ4W after an initial loading dose of 450mg, 300mgQ4W after an initial loading dose of 450mg, or placebo during a 24-week Treatment Phase. Patients were then followed for an additional 16 weeks with no study treatment. The primary endpoint was to evaluate the clinical effect of barzolvolimab compared to placebo on itch response as measured by the proportion of patients with ≥ 4-point improvement in the worst intensity itch per a numeric rating scale (WI-NRS) at Week 12. Key secondary objectives included itch response at different timepoints, the assessment of skin lesions as measured by the Investigator Global Assessment (IGA) and safety. In addition, the study included the option for patients who had symptoms following the treatment phase, including patients who were on placebo, to enroll in an open label extension. The study enrolled patients at 48 centers across six countries, including the United States. For additional information on this trial (NCT06366750), please visit www.clinicaltrials.gov. Webcast and Conference Call  The Company will host a conference call/webcast today to discuss the results at 4:30 p.m. ET. To access the live and archived webcast, please visit the Events section on the Investor Relations page of Celldex’s website. Parties interested in participating via telephone may register here to receive the dial-in numbers and unique PIN to seamlessly access the call. Otherwise, please access the listen-only webcast link. The archived webcast will be available for a limited time on the Company’s website. About BarzolvolimabBarzolvolimab is a humanized monoclonal antibody with a novel mechanism of action that targets mast cells by binding with high specificity to a unique part of the KIT receptor and potently inhibiting its activity. The KIT receptor is abundantly expressed by mast cells and critical for their function and survival. Mast cells are drivers of inflammatory responses such as hypersensitivity and allergic reactions and, in certain inflammatory diseases, such as chronic urticarias, mast cell activation plays a central role in the onset and progression of the disease. Based on data from robust, randomized, placebo controlled Phase 2 studies, barzolvolimab has significant potential as a first-in-class and best-in-disease treatment option for patients with chronic spontaneous urticaria (CSU), cold urticaria (ColdU) and symptomatic dermographism (SD). Barzolvolimab is currently being studied in Phase 3 studies in CSU and ColdU/SD and a Phase 2 study in atopic dermatitis (AD), with additional indications planned for the future. About CelldexCelldex is pioneering new horizons in immunology to deliver life-changing therapies. We are relentless in our pursuit of novel antibody-based treatments that engage the human immune system and directly affect critical pathways to improve the lives of patients with allergic, inflammatory and autoimmune disorders. Visit www.celldex.com. Forward Looking StatementThis release contains “forward-looking statements” made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. These statements are typically preceded by words such as “believes,” “expects,” “anticipates,” “intends,” “will,” “may,” “should,” or similar expressions. These forward-looking statements reflect management's current knowledge, assumptions, judgment and expectations regarding future performance or events. Although management believes that the expectations reflected in such statements are reasonable, they give no assurance that such expectations will prove to be correct or that those goals will be achieved, and you should be aware that actual results could differ materially from those contained in the forward-looking statements. Forward-looking statements are subject to a number of risks and uncertainties, including, but not limited to, our ability to successfully complete research and further development and commercialization of Company drug candidates, including barzolvolimab (also referred to as CDX-0159) and CDX-622, in current or future indications; the uncertainties inherent in clinical testing and accruing patients for clinical trials; our limited experience in bringing programs through Phase 3 clinical trials; our ability to manage and successfully complete multiple clinical trials and the research and development efforts for our multiple products at varying stages of development; the availability, cost, delivery and quality of clinical materials produced by our own manufacturing facility or supplied by contract manufacturers, who may be our sole source of supply; the timing, cost and uncertainty of obtaining regulatory approvals; the failure of the market for the Company's programs to continue to develop; our ability to protect the Company's intellectual property; the loss of any executive officers or key personnel or consultants; competition; changes in the regulatory landscape or the imposition of regulations that affect the Company's products; our ability to continue to obtain capital to meet our long-term liquidity needs on acceptable terms, or at all, including the additional capital which will be necessary to complete the clinical trials that we have initiated or plan to initiate; and other factors listed under “Risk Factors“ in our annual report on Form 10-K and quarterly reports on Form 10-Q. All forward-looking statements are expressly qualified in their entirety by this cautionary notice. You are cautioned not to place undue reliance on any forward-looking statements, which speak only as of the date of this release. We have no obligation, and expressly disclaim any obligation, to update, revise or correct any of the forward-looking statements, whether as a result of new information, future events or otherwise. Company ContactsSarah CavanaughSenior Vice President, Corporate Affairs & Administration(508) [email protected] Elizabeth HigginsExecutive Director, Investor Relations & Corporate Communications(857) [email protected]

CDX-622 is a novel, bispecific antibody combining mast cell depletion and TSLP inhibition, two independent pathways contributing to multiple I&I diseases CDX-622 targets the soluble form of stem cell factor (SCF), depleting mast cells without measurably impacting other KIT functions Rapid, profound, dose-dependent, and durable reductions in serum tryptase observed Well-tolerated at all dose levels First company to demonstrate that neutralizing soluble SCF can selectively inhibit KIT signaling in mast cells HAMPTON, N.J., June 14, 2026 (GLOBE NEWSWIRE) -- Celldex (NASDAQ:CLDX) today presented positive results from the Phase 1 healthy participant study of CDX-622, a novel, bispecific antibody that targets soluble SCF and TSLP, at the European Academy of Allergy and Clinical Immunology (EAACI) Annual Meeting in Istanbul, Türkiye. Data demonstrated that CDX-622 induced rapid, durable, dose-dependent reductions in serum tryptase, indicative of mast cell depletion, and was well-tolerated at all dose levels. Building on Celldex’s leadership in mast cell science, the data also demonstrated that neutralizing soluble stem cell factor (SCF) enables the potential for meaningful mast cell inhibition and depletion without impacting other KIT-dependent functions. CDX-622 is currently being studied in a Phase 1b proof of mechanism study in mild to moderate asthma to assess the impact of dual neutralization of SCF and TSLP. “Celldex continues to drive groundbreaking science and is the first company to directly demonstrate that neutralizing soluble stem cell factor can selectively inhibit KIT signaling in mast cells, a historically challenging target,” said Tibor Keler, Ph.D., Co-founder, Executive Vice President and Chief Scientific Officer at Celldex. “Importantly, the approach of targeting soluble SCF provides a promising anchor mechanism enabling the development of a robust portfolio of bispecific candidates designed to overcome the heterogeneity inherent in the pathophysiology of many inflammatory diseases. Today’s results from CDX-622 highlight the potential of this approach and we look forward to initiating additional proof of concept studies in multiple indications where both mast cells and TSLP play a pathogenic role, focusing next on allergic rhinitis and food allergy.” “Mast cell targeting strategies are rapidly emerging as powerful therapeutic approaches in inflammatory diseases. Leveraging our expertise in antibody drug development, and building on our success with barzolvolimab, Celldex is committed to driving innovation across the field of mast cell science to bring our leading science to additional patient populations that could benefit from our medicines,” said  Anthony Marucci, Co-Founder, President and Chief Executive Officer at Celldex. “Barzolvolimab and CDX-622 target mast cells through two distinct, highly synergistic platform approaches. Together, these novel candidates build a powerful foundation for a broad portfolio of therapeutics targeting a wide range of inflammatory diseases where mast cells are implicated. We look forward to sharing more about our growing pipeline in the future.” Data Summary: CDX-622 is a uniquely engineered novel bispecific antibody that targets soluble SCF and alarmin thymic stromal lymphopoietin (TSLP), two critical pathways that may contribute to the pathology of several allergic and inflammatory disorders with significant unmet medical need. Combined neutralization of SCF and TSLP with CDX-622 is expected to simultaneously reduce tissue mast cells and inhibit Type 2 inflammatory responses, allowing for a complementary dual mechanism approach that may overcome the heterogeneity inherent in the pathophysiology of many inflammatory disorders. CDX-622 has been engineered to disable effector function (AQQ) and enhance half-life (YTE). Rapid, profound, dose-dependent, and durable reductions in serum tryptase were observed, indicative of tissue mast cell inhibition and depletion. CDX-622 exhibited monoclonal antibody-like pharmacokinetics, with extended half-life and good exposure with subcutaneous administration, consistent with good bioavailability. CDX-622 was well-tolerated in all study parts and at all dose levels. There were no dose-limiting toxicities or related serious adverse events. Additionally, in June, Celldex presented new non-human primate data at the European Mast Cell and Basophil Research Network (EMBRN) that validates the approach of targeting soluble SCF to deplete mast cells. The preclinical study evaluated antibodies either targeting soluble SCF or both soluble and the membrane form of SCF. The data showed that targeting soluble SCF effectively depleted mast cells in a manner similar to targeting membrane SCF, but without measurable effect on spermatogenesis or melanogenesis in non-human primates. Results support that combined TSLP neutralization and mast cell depletion with CDX-622 may result in broad efficacy in inflammatory diseases where both pathways play a pathogenic role. About the Phase 1 StudyThe Phase 1 trial was a randomized, double-blind, placebo-controlled, dose escalation study designed to assess the safety, pharmacokinetics, pharmacodynamics and immunogenicity of single ascending doses (Part 1) and multiple ascending doses (Part 2) of CDX-622 in healthy participants. The study also included a single ascending dose of CDX-622 administered subcutaneously (Part 3). 32 participants were enrolled in Part 1 across 4 cohorts (8 participants per cohort; n=6 CDX-622, n=2 placebo) and received single ascending intravenous doses of CDX-622 (0.3, 1.0, 3.0 and 9.0 mg/kg) and were observed over a 12-week period. 24 participants were enrolled in Part 2 across 3 cohorts (8 participants per cohort; n=6 CDX-622, n=2 placebo) and received multiple ascending intravenous doses of CDX-622 (1.0, 3.0, and 9.0 mg/kg at weeks 2, 4, and 6) and were observed for 18 weeks. 24 participants were enrolled in Part 3 across 3 cohorts (8 participants per cohort; n=6 CDX-622, n=2 placebo) and received single ascending subcutaneous doses of CDX-622 (290, 580, and 870 mg) and were observed for 12 weeks. Data from Part 1 were previously presented in October 2025. About 622: CDX-622 is a bispecific antibody that targets two complementary, clinically validated pathways that drive chronic inflammation, potently neutralizing the alarmin thymic stromal lymphopoietin (TSLP) and depleting mast cells via stem cell factor (SCF) starvation. SCF activation of the KIT receptor is required for mast cell survival and plays a key role in their activation, maturation and tissue recruitment. Combined neutralization of SCF and TSLP with CDX-622 is expected to simultaneously reduce tissue mast cells and inhibit Type 2 inflammatory responses to potentially offer enhanced therapeutic benefit in inflammatory and fibrotic disorders. About Barzolvolimab: Barzolvolimab is a humanized monoclonal antibody with a novel mechanism of action that targets mast cells by binding with high specificity to a unique part of the KIT receptor and potently inhibiting its activity. The KIT receptor is abundantly expressed by mast cells and critical for their function and survival. Mast cells are drivers of inflammatory responses such as hypersensitivity and allergic reactions and, in certain inflammatory diseases, such as chronic urticarias, mast cell activation plays a central role in the onset and progression of the disease. Based on data from robust, randomized, placebo controlled Phase 2 studies, barzolvolimab has significant potential as a first-in-class and best-in-disease treatment option for patients with chronic spontaneous urticaria (CSU), cold urticaria (ColdU) and symptomatic dermographism (SD). Barzolvolimab is currently being studied in Phase 3 studies in CSU and ColdU/SD and Phase 2 studies in prurigo nodularis (PN) and atopic dermatitis (AD), with additional indications planned for the future. About CelldexCelldex is pioneering new horizons in immunology to deliver life-changing therapies. We are relentless in our pursuit of novel antibody-based treatments that engage the human immune system and directly affect critical pathways to improve the lives of patients with allergic, inflammatory and autoimmune disorders. Visit www.celldex.com. Forward Looking StatementThis release contains "forward-looking statements" made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. These statements are typically preceded by words such as "believes," "expects," "anticipates," "intends," "will," "may," "should," or similar expressions. These forward-looking statements reflect management's current knowledge, assumptions, judgment and expectations regarding future performance or events. Although management believes that the expectations reflected in such statements are reasonable, they give no assurance that such expectations will prove to be correct or that those goals will be achieved, and you should be aware that actual results could differ materially from those contained in the forward-looking statements. Forward-looking statements are subject to a number of risks and uncertainties, including, but not limited to, our ability to successfully complete research and further development and commercialization of Company drug candidates, including barzolvolimab (also referred to as CDX-0159) and CDX-622, in current or future indications; the uncertainties inherent in clinical testing and accruing patients for clinical trials; our limited experience in bringing programs through Phase 3 clinical trials; our ability to manage and successfully complete multiple clinical trials and the research and development efforts for our multiple products at varying stages of development; the availability, cost, delivery and quality of clinical materials produced by our own manufacturing facility or supplied by contract manufacturers, who may be our sole source of supply; the timing, cost and uncertainty of obtaining regulatory approvals; the failure of the market for the Company's programs to continue to develop; our ability to protect the Company's intellectual property; the loss of any executive officers or key personnel or consultants; competition; changes in the regulatory landscape or the imposition of regulations that affect the Company's products; our ability to continue to obtain capital to meet our long-term liquidity needs on acceptable terms, or at all, including the additional capital which will be necessary to complete the clinical trials that we have initiated or plan to initiate; and other factors listed under "Risk Factors" in our annual report on Form 10-K and quarterly reports on Form 10-Q. All forward-looking statements are expressly qualified in their entirety by this cautionary notice. You are cautioned not to place undue reliance on any forward-looking statements, which speak only as of the date of this release. We have no obligation, and expressly disclaim any obligation, to update, revise or correct any of the forward-looking statements, whether as a result of new information, future events or otherwise. Company ContactSarah CavanaughSenior Vice President, Corporate Affairs & Administration(508) [email protected] Elizabeth HigginsExecutive Director, Investor Relations and Corporate Communications(857) [email protected]

Treatment with barzolvolimab resulted in rapid, significant, and durable improvements in angioedema in patients with moderate to severe CSU Seven months after the completion of dosing (Week 76), up to 64% of patients treated with barzolvolimab who had angioedema at baseline remained angioedema-free Barzolvolimab has potential to shift treatment goals from symptom control to disease modification Results continue to support ongoing Phase 3 trials of barzolvolimab in CSU; topline data expected in Q4 2026 HAMPTON, N.J., June 14, 2026 (GLOBE NEWSWIRE) -- Celldex (NASDAQ:CLDX) announced today the presentation of long-term results from the Phase 2 study of barzolvolimab in a flash talk session at the European Academy of Allergy and Clinical Immunology (EAACI) Annual Meeting in Istanbul, Türkiye. The data presented demonstrated that barzolvolimab treatment results in rapid, significant, and durable improvements in angioedema in patients with chronic spontaneous urticaria (CSU) refractory to antihistamines. These results were sustained off-treatment, seven months after completion of barzolvolimab dosing (Week 76). The data continue to demonstrate barzolvolimab’s potential to shift the goal of CSU treatment from symptom control to disease modification and further support the ongoing Phase 3 trials of barzolvolimab in CSU. “Angioedema plays a major role in the physical and mental health of the majority of people living with CSU, causing extremely painful swelling and disfigurement that dramatically impacts quality of life,” said Diane C. Young, MD, Senior Vice President and Chief Medical Officer of Celldex Therapeutics. “Barzolvolimab has consistently shown profound, lasting results including high rates of complete response, defined as complete absence of itch and hives, and dramatic improvements in quality of life and angioedema control through 52 weeks of therapy and now seven months after the last dose, demonstrating its potential for disease modification and the ability to change how CSU patients live their lives.” Angioedema occurs in 55% of people with CSU1 and patients report a mean of 7.7 angioedema episodes annually.2 Patients with CSU-related angioedema report significantly worse physical and mental health outcomes, lower health related quality of life, a higher percentage of anxiety and depression, along with significantly increased emergency room visits and hospitalizations compared to patients without angioedema in the United States.3,4 Similarly, these patients report significantly higher work and activity impairment than those without angioedema.5 Both patients and physicians report being free of angioedema as an important treatment goal in CSU.6 As previously reported, data from the Phase 2b trial showed that treatment with barzolvolimab resulted in rapid, significant, and durable improvements in angioedema. Relief from angioedema symptoms began as early as Week 1 and deepened over 52 weeks of treatment. Furthermore, newly presented data show that barzolvolimab treatment led to robust and sustained reductions in angioedema symptoms at Week 76, demonstrating prolonged off-treatment benefits. Up to 64% of patients who had angioedema at baseline were angioedema-free 7 months after the last dose. Two Phase 3 trials of barzolvolimab in CSU are ongoing and enrollment is complete. 1,939 patients were enrolled, the largest program conducted in antihistamine-refractory CSU, including patients with advanced therapy experienced/refractory CSU. The studies included 43 countries across 500 sites. Topline data are anticipated in Q4 2026, supporting a planned BLA submission in 2027. 1Kolkhir P, et al. Nat Rev Dis Primers. 2022 Sep 15;8(1):61 2Weller, et al. Dermatol Ther, 2025. 3Balp M, et al. Burden of angioedema in patients with chronic spontaneous urticaria in EU5 and US, EADV Congress 2023. 4Balp M, et al. Characterization of chronic spontaneous urticaria among patients in EU5, US and Japan. EADV Congress 2023. 5Soong W, et al. World Allergy Organ J. 2025. 6Bernstein J, et al. Frequency of angioedema in chronic spontaneous urticaria patients: Report from the Urticaria Voices study, GA2LEN Global Urticaria Forum 2024. About BarzolvolimabBarzolvolimab is a humanized monoclonal antibody with a novel mechanism of action that targets mast cells by binding with high specificity to a unique part of the KIT receptor and potently inhibiting its activity. The KIT receptor is abundantly expressed by mast cells and critical for their function and survival. Mast cells are drivers of inflammatory responses such as hypersensitivity and allergic reactions and, in certain inflammatory diseases, such as chronic urticarias, mast cell activation plays a central role in the onset and progression of the disease. Based on data from robust, randomized, placebo controlled Phase 2 studies, barzolvolimab has significant potential as a first-in-class and best-in-disease treatment option for patients with chronic spontaneous urticaria (CSU), cold urticaria (ColdU) and symptomatic dermographism (SD). Barzolvolimab is currently being studied in Phase 3 studies in CSU and ColdU/SD and Phase 2 studies in prurigo nodularis (PN) and atopic dermatitis (AD), with additional indications planned for the future. About the Phase 2 CSU StudyThe randomized, double-blind, placebo-controlled, parallel group Phase 2 study evaluated the efficacy and safety profile of multiple dose regimens of barzolvolimab in patients with CSU who remain symptomatic despite antihistamine therapy, to determine the optimal dosing strategy. 208 patients were randomly assigned on a 1:1:1:1 ratio to receive subcutaneous injections of barzolvolimab at 75 mg every 4 weeks, 150 mg every 4 weeks, 300 mg every 8 weeks or placebo during a 16-week placebo-controlled treatment period. After 16 weeks, patients then entered a 36-week active treatment period, in which patients receiving placebo or the 75 mg dose were randomized to receive barzolvolimab 150 mg every 4 weeks or 300 mg every 8 weeks; patients already randomized to the 150 mg and 300 mg treatment arms remained on the same regimen as during the placebo-controlled treatment period. After 52 weeks, patients entered a follow-up period for an additional 24 weeks. Barzolvolimab achieved the primary efficacy endpoint of the study—a statistically significant mean change from baseline to Week 12 in UAS7 (weekly urticaria activity score) compared to placebo at all dose levels. For additional information on this trial (NCT05368285), please visit www.clinicaltrials.gov. About CelldexCelldex is pioneering new horizons in immunology to deliver life-changing therapies. We are relentless in our pursuit of novel antibody-based treatments that engage the human immune system and directly affect critical pathways to improve the lives of patients with allergic, inflammatory and autoimmune disorders. Visit www.celldex.com. Forward Looking StatementThis release contains “forward-looking statements” made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. These statements are typically preceded by words such as “believes,” “expects,” “anticipates,” “intends,” “will,” “may,” “should,” or similar expressions. These forward-looking statements reflect management's current knowledge, assumptions, judgment and expectations regarding future performance or events. Although management believes that the expectations reflected in such statements are reasonable, they give no assurance that such expectations will prove to be correct or that those goals will be achieved, and you should be aware that actual results could differ materially from those contained in the forward-looking statements. Forward-looking statements are subject to a number of risks and uncertainties, including, but not limited to, our ability to successfully complete research and further development and commercialization of Company drug candidates, including barzolvolimab (also referred to as CDX-0159) and CDX-622, in current or future indications; the uncertainties inherent in clinical testing and accruing patients for clinical trials; our limited experience in bringing programs through Phase 3 clinical trials; our ability to manage and successfully complete multiple clinical trials and the research and development efforts for our multiple products at varying stages of development; the availability, cost, delivery and quality of clinical materials produced by our own manufacturing facility or supplied by contract manufacturers, who may be our sole source of supply; the timing, cost and uncertainty of obtaining regulatory approvals; the failure of the market for the Company's programs to continue to develop; our ability to protect the Company's intellectual property; the loss of any executive officers or key personnel or consultants; competition; changes in the regulatory landscape or the imposition of regulations that affect the Company's products; our ability to continue to obtain capital to meet our long-term liquidity needs on acceptable terms, or at all, including the additional capital which will be necessary to complete the clinical trials that we have initiated or plan to initiate; and other factors listed under “Risk Factors“ in our annual report on Form 10-K and quarterly reports on Form 10-Q. All forward-looking statements are expressly qualified in their entirety by this cautionary notice. You are cautioned not to place undue reliance on any forward-looking statements, which speak only as of the date of this release. We have no obligation, and expressly disclaim any obligation, to update, revise or correct any of the forward-looking statements, whether as a result of new information, future events or otherwise. Company ContactsSarah CavanaughSenior Vice President, Corporate Affairs & Administration(508) [email protected] Elizabeth HigginsExecutive Director, Investor Relations & Corporate Communications (857) [email protected]

Enrollment completed six months ahead of guidance in both barzolvolimab Phase 3 chronic spontaneous urticaria studies (EMBARQ-CSU 1 and 2); Topline data expected in Q4 26; BLA submission planned for 2027 Phase 3 barzolvolimab cold urticaria and symptomatic dermographism study (EMBARQ-ColdU and -SD) actively enrolling Phase 1 CDX-622 proof of mechanism study in asthma ongoing 2026 expected to deliver multiple key data readouts across the pipeline Raised $345 million in gross proceeds from a follow-on public offering, closed in April 2026 HAMPTON, N.J., May 07, 2026 (GLOBE NEWSWIRE) -- Celldex (NASDAQ:CLDX) today reported financial results for the first quarter ended March 31, 2026 and provided a corporate update. "We began the year with a significant milestone - the early completion of enrollment in our Phase 3 CSU studies - and we have continued to build on that momentum over the quarter,” said Anthony Marucci, Co-founder, President and Chief Executive Officer of Celldex. “This spring, barzolvolimab was featured in five presentations at leading medical meetings, further reinforcing its potential as a first-in-class, best-in-disease therapy with the ability to transform the treatment landscape for patients in need of better options. This progress enabled the successful completion of a $345 million financing in early April, strengthening our balance sheet and supporting continued investments in our commercialization preparations and growing pipeline.” “As we look ahead, our focus remains on execution—driving strong enrollment across our Phase 3 study in ColdU and SD and advancing towards multiple important data readouts this year,” Mr. Marucci continued. “These include topline data from our Phase 3 barzolvolimab CSU studies, results from Phase 2 studies in prurigo nodularis and atopic dermatitis, and additional data from our novel bispecific program, CDX-622.” Recent Program Highlights Barzolvolimab - KIT Inhibitor Program Barzolvolimab is a humanized monoclonal antibody with a novel mechanism of action that targets mast cells by binding with high specificity to a unique part of the KIT receptor and potently inhibiting its activity. The KIT receptor is abundantly expressed by mast cells and critical for their function and survival. Mast cells are drivers of inflammatory responses such as hypersensitivity and allergic reactions and, in certain inflammatory diseases, such as chronic urticarias, mast cell activation plays a central role in the onset and progression of the disease. Chronic Urticarias Enrollment was completed six months ahead of guidance in the global Phase 3 program in chronic spontaneous urticaria (CSU)—demonstrating strong interest in barzolvolimab. The Phase 3 program consists of two trials—EMBARQ-CSU1 and EMBARQ-CSU2. 1,939 patients were enrolled—the largest program conducted in antihistamine refractory CSU, including patients with advanced therapy experienced/refractory CSU. The studies included 43 countries and over 500 sites. EMBARQ-CSU1 and EMBARQ-CSU2 are designed to establish the efficacy and safety of barzolvolimab in adult patients with CSU who remain symptomatic despite H1 antihistamine treatment and also include patients who remain symptomatic after treatment with advanced therapies. Topline data are anticipated in Q4 2026, supporting a planned BLA filing in 2027. In December 2025, Celldex initiated a global Phase 3 study in cold urticaria (ColdU) and symptomatic dermographism (SD)—EMBARQ-ColdU and -SD. Barzolvolimab is the first drug in development to demonstrate clinical benefit in patients with ColdU and SD in a large, randomized, placebo-controlled study. In the recently completed Phase 2 study, all primary and secondary endpoints were met with high statistical significance at 12 weeks and sustained through the end of the treatment period (20 weeks). Data from the Phase 2 studies of barzolvolimab in both CSU and ColdU/SD were presented at the 2026 AAAAI Annual Meeting (February 27 – March 2) and the 2026 AAD Annual Meeting (March 27 – 31) further demonstrating a first-in-class and best-in-disease profile. Key highlights include: Barzolvolimab retreatment achieves similar profound efficacy to first exposure in patients with ColdU and SD; ability to retreat facilitates a real-world paradigm in which treatment may be intermittent for patients with ColdU and SD Sustained off-treatment efficacy despite barzolvolimab clearance and normalization of tryptase, suggesting disease modification in patients with CSU treated for full 52 weeks Greatly improved quality of life and reduced disease impact for patients with ColdU/SD at Week 20 Greatly improved quality of life and reduced disease impact for patients with CSU, ColdU and SD across all measured domains: symptoms and feelings, daily activities, leisure, work and school, personal relationships and treatment Prurigo Nodularis and Atopic Dermatitis Enrollment is complete in the Phase 2 study in prurigo nodularis (PN). This randomized, double-blind, placebo-controlled, parallel group study is evaluating the efficacy and safety profile of barzolvolimab in patients with moderate to severe PN. Topline data from this study are expected to be presented in the summer of 2026. Enrollment is complete in the Phase 2 study in atopic dermatitis (AD). This randomized, double-blind, placebo-controlled, parallel group study is evaluating the efficacy and safety profile of barzolvolimab in patients with moderate to severe AD. Topline data from this study are expected to be presented in late 2026. Novel Bispecific Antibody Platform CDX-622 – Bispecific SCF & TSLP CDX-622 targets two complementary pathways that drive chronic inflammation, potently neutralizing the alarmin thymic stromal lymphopoietin (TSLP) and depleting mast cells via stem cell factor (SCF) starvation. Combined neutralization of SCF and TSLP with CDX-622 is expected to simultaneously reduce tissue mast cells and inhibit Type 2 inflammatory responses to potentially offer enhanced therapeutic benefit in inflammatory and fibrotic disorders. CDX-622 has been engineered to disable effector function (AQQ) and enhance half-life (YTE). Enrollment is complete in the multi-part Phase 1 study in healthy volunteers. Positive data from the single ascending dose portion of the study was presented in October 2025. Data from the multiple ascending dose portion of the study and SubQ administration are anticipated in the third quarter of 2026. The pharmacodynamic biomarkers from blood and skin will be highly informative on the ability of CDX-622 to engage and neutralize SCF and TSLP. In January 2026, we initiated an open-label, single-dose Phase 1 proof of mechanism (POM) study to assess the safety, pharmacodynamics, and pharmacokinetics of CDX-622 in adults with mild to moderate asthma. Participants will receive a single IV infusion of CDX-622 and be followed for 12 weeks. PD effects of CDX-622 on fractional exhaled nitric oxide (FeNO), absolute eosinophil count (AEC) and serum biomarkers, including TSLP- and SCF-related biomarkers, will be evaluated. First Quarter 2026 Financial Highlights and 2026 Guidance Cash Position: Cash, cash equivalents and marketable securities as of March 31, 2026 were $451.5 million compared to $518.6 million as of December 31, 2025. The decrease was primarily driven by first quarter cash used in operating activities of $65.6 million. At March 31, 2026, Celldex had 66.6 million shares outstanding. In April 2026, the Company issued 11,896,750 shares of its common stock in an underwritten public offering, resulting in gross proceeds to the Company of $345.0 million. Revenues: Total revenue was $0.0 million in the first quarter of 2026, compared to $0.7 million for the comparable period in 2025. The decrease in revenue was primarily due to a decrease in services performed under our manufacturing and research and development agreements with Rockefeller University. R&D Expenses: Research and development (R&D) expenses were $73.0 million in the first quarter of 2026, compared to $52.6 million for the comparable period in 2025. The increase in R&D expenses was primarily due to an increase in barzolvolimab clinical trial and contract manufacturing expenses and an increase in employee headcount. G&A Expenses: General and administrative (G&A) expenses were $11.4 million in the first quarter of 2026, compared to $10.8 million for the comparable period in 2025. The increase in G&A expenses was primarily due to an increase in barzolvolimab commercial planning expenses. Net Loss: Net loss was $78.7 million, or ($1.18) per share, for the first quarter of 2026, compared to a net loss of $53.8 million, or ($0.81) per share, for the comparable period in 2025. Financial Guidance: Celldex believes that the cash, cash equivalents and marketable securities at March 31, 2026, along with the approximately $323.9 million in net proceeds from our April 2026 underwritten public offering, are sufficient to meet estimated working capital requirements and fund current planned operations through 2028. About Celldex Celldex is pioneering new horizons in immunology to deliver life-changing therapies. We are relentless in our pursuit of novel antibody-based treatments that engage the human immune system and directly affect critical pathways to improve the lives of patients with allergic, inflammatory and autoimmune disorders. Visit www.celldex.com. Forward Looking Statement This release contains "forward-looking statements" made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. These statements are typically preceded by words such as "believes," "expects," "anticipates," "intends," "will," "may," "should," or similar expressions. These forward-looking statements reflect management's current knowledge, assumptions, judgment and expectations regarding future performance or events. Although management believes that the expectations reflected in such statements are reasonable, they give no assurance that such expectations will prove to be correct or that those goals will be achieved, and you should be aware that actual results could differ materially from those contained in the forward-looking statements. Forward-looking statements are subject to a number of risks and uncertainties, including, but not limited to, our ability to successfully complete research and further development and commercialization of Company drug candidates, including barzolvolimab (also referred to as CDX-0159) and CDX-622, in current or future indications; the uncertainties inherent in clinical testing and accruing patients for clinical trials; our limited experience in bringing programs through Phase 3 clinical trials; our ability to manage and successfully complete multiple clinical trials and the research and development efforts for our multiple products at varying stages of development; the availability, cost, delivery and quality of clinical materials produced by our own manufacturing facility or supplied by contract manufacturers, who may be our sole source of supply; the timing, cost and uncertainty of obtaining regulatory approvals; the failure of the market for the Company's programs to continue to develop; our ability to protect the Company's intellectual property; the loss of any executive officers or key personnel or consultants; competition; changes in the regulatory landscape or the imposition of regulations that affect the Company's products; our ability to continue to obtain capital to meet our long-term liquidity needs on acceptable terms, or at all, including the additional capital which will be necessary to complete the clinical trials that we have initiated or plan to initiate; and other factors listed under "Risk Factors" in our annual report on Form 10-K and quarterly reports on Form 10-Q. All forward-looking statements are expressly qualified in their entirety by this cautionary notice. You are cautioned not to place undue reliance on any forward-looking statements, which speak only as of the date of this release. We have no obligation, and expressly disclaim any obligation, to update, revise or correct any of the forward-looking statements, whether as a result of new information, future events or otherwise. Company Contact Sarah Cavanaugh Senior Vice President, Corporate Affairs & Administration (508) 864-8337 [email protected] Patrick Till Meru Advisors (484) 788-8560 [email protected]

Innoviva (INVA) came out with quarterly earnings of $0.44 per share, beating the Zacks Consensus Estimate of $0.43 per share. This compares to earnings of $0.25 per share a year ago. These figures are adjusted for non-recurring items. This quarterly report represents an earnings surprise of +3.53%. A quarter ago, it was expected that this biopharmaceutical company would post earnings of $0.34 per share when it actually produced earnings of $1.94, delivering a surprise of +470.59%. Over the last four quarters, the company has surpassed consensus EPS estimates four times. Innoviva, which belongs to the Zacks Large Cap Pharmaceuticals industry, posted revenues of $97.99 million for the quarter ended March 2026, missing the Zacks Consensus Estimate by 1.83%. This compares to year-ago revenues of $88.63 million. The company has topped consensus revenue estimates three times over the last four quarters. The sustainability of the stock's immediate price movement based on the recently-released numbers and future earnings expectations will mostly depend on management's commentary on the earnings call. Innoviva shares have added about 13.3% since the beginning of the year versus the S&P 500's gain of 6%. While Innoviva has outperformed the market so far this year, the question that comes to investors' minds is: what's next for the stock? There are no easy answers to this key question, but one reliable measure that can help investors address this is the company's earnings outlook. Not only does this include current consensus earnings expectations for the coming quarter(s), but also how these expectations have changed lately. Empirical research shows a strong correlation between near-term stock movements and trends in earnings estimate revisions. Investors can track such revisions by themselves or rely on a tried-and-tested rating tool like the Zacks Rank, which has an impressive track record of harnessing the power of earnings estimate revisions. Ahead of this earnings release, the estimate revisions trend for Innoviva was mixed. While the magnitude and direction of estimate revisions could change following the company's just-released earnings report, the current status translates into a Zacks Rank #3 (Hold) for the stock. So, the shares are expected to perform in line with the market in the near future. You can see the complete list of today's Zacks #1 Rank (Strong Buy) stocks here. It will be interesting to see how estimates for the coming quarters and the current fiscal year change in the days ahead. The current consensus EPS estimate is $0.51 on $110.88 million in revenues for the coming quarter and $1.99 on $435.81 million in revenues for the current fiscal year. Investors should be mindful of the fact that the outlook for the industry can have a material impact on the performance of the stock as well. In terms of the Zacks Industry Rank, Large Cap Pharmaceuticals is currently in the bottom 28% of the 250 plus Zacks industries. Our research shows that the top 50% of the Zacks-ranked industries outperform the bottom 50% by a factor of more than 2 to 1. One other stock from the broader Zacks Medical sector, Celldex Therapeutics (CLDX), is yet to report results for the quarter ended March 2026. This biopharmaceutical company is expected to post quarterly loss of $1.10 per share in its upcoming report, which represents a year-over-year change of -35.8%. The consensus EPS estimate for the quarter has remained unchanged over the last 30 days. Celldex Therapeutics' revenues are expected to be $1.32 million, up 91.7% from the year-ago quarter. Want the latest recommendations from Zacks Investment Research? Today, you can download 7 Best Stocks for the Next 30 Days. Click to get this free report Innoviva, Inc. (INVA) : Free Stock Analysis Report Celldex Therapeutics, Inc. (CLDX) : Free Stock Analysis Report This article originally published on Zacks Investment Research (zacks.com). Zacks Investment Research

Enrollment completed in both Phase 3 chronic spontaneous urticaria global registration studies (EMBARQ-CSU 1 and 2) six months ahead of guidance; Topline data expected in Q4 26; BLA submission planned for 2027 Phase 3 cold urticaria and symptomatic dermographism study (EMBARQ-ColdU and -SD) actively accruing Enrollment completed in Phase 2 prurigo nodularis and atopic dermatitis studies with topline data expected in 2026 Phase 1 CDX-622 Proof of Mechanism study in asthma initiated Company prepares for landmark year of clinical readouts in 2026 HAMPTON, N.J., Feb. 25, 2026 (GLOBE NEWSWIRE) -- Celldex (NASDAQ:CLDX) today reported financial results for the fourth quarter and year ended December 31, 2025 and provided a corporate update. "The enthusiasm for barzolvolimab continues to build, driven by unparalleled efficacy data across multiple indications,” said Anthony Marucci, Co-founder, President and Chief Executive Officer of Celldex. “This is underscored by the completion of enrollment in our Phase 3 CSU studies six months ahead of guidance and strong interest from clinical trial sites in our recently initiated Phase 3 study in cold urticaria and symptomatic dermographism.” “During 2026, we are excited for multiple important data readouts across our pipeline, including topline data from our barzolvolimab Phase 3 studies in CSU, Phase 2 studies in prurigo nodularis and atopic dermatitis, and additional data from our novel bispecific program, CDX-622,” continued Mr. Marucci. “We continue to prepare for the planned BLA filing and commercialization of barzolvolimab in CSU, which has the potential to transform the treatment landscape and position Celldex as a pioneering immunology company—leading in mast cell biology and delivering groundbreaking therapies for patients who are waiting for better treatment options.” Recent Program Highlights Barzolvolimab - KIT Inhibitor Program Barzolvolimab is a humanized monoclonal antibody with a novel mechanism of action that targets mast cells by binding with high specificity to a unique part of the KIT receptor and potently inhibiting its activity. The KIT receptor is abundantly expressed by mast cells and critical for their function and survival. Mast cells are drivers of inflammatory responses such as hypersensitivity and allergic reactions and, in certain inflammatory diseases, such as chronic urticarias, mast cell activation plays a central role in the onset and progression of the disease. Chronic Urticarias This morning, Celldex announced that enrollment was completed six months ahead of guidance in the global Phase 3 program in chronic spontaneous urticaria (CSU)—demonstrating strong interest in barzolvolimab. The Phase 3 program consists of two trials—EMBARQ-CSU1 and EMBARQ-CSU2. 1,939 patients were enrolled—the largest program conducted in antihistamine refractory CSU, including patients with advanced therapy experienced/refractory CSU. The studies included 43 countries and over 500 sites. EMBARQ-CSU1 and EMBARQ-CSU2 are designed to establish the efficacy and safety of barzolvolimab in adult patients with CSU who remain symptomatic despite H1 antihistamine treatment and also include patients who remain symptomatic after treatment with advanced therapies. Topline data are anticipated in Q4 2026, supporting a planned BLA filing in 2027. In December 2025, Celldex initiated a global Phase 3 study in cold urticaria (ColdU) and symptomatic dermographism (SD)—EMBARQ-ColdU and -SD. Barzolvolimab is the first drug in development to demonstrate clinical benefit in patients with ColdU and SD in a large, randomized, placebo-controlled study. In the recently completed Phase 2 study, all primary and secondary endpoints were met with high statistical significance at 12 weeks and sustained through the end of the treatment period (20 weeks). Data from the Phase 2 studies of barzolvolimab in both CSU and ColdU/SD have been accepted for multiple presentations at the 2026 AAAAI Annual Meeting (February 27 – March 2). This includes a late breaking poster presentation on new data from the Phase 2 ColdU and SD study entitled “Retreatment with Barzolvolimab Leads to Rapid Improvement in Urticaria Control After Symptom Recurrence in Chronic Inducible Urticaria” on Sunday, March 1, 2026. Prurigo Nodularis and Atopic Dermatitis Enrollment is complete in the Phase 2 study in prurigo nodularis (PN). This randomized, double-blind, placebo-controlled, parallel group study is evaluating the efficacy and safety profile of barzolvolimab in patients with moderate to severe PN. Topline data from this study are expected to be presented in the summer of 2026. Enrollment is complete in the Phase 2 study in atopic dermatitis (AD). This randomized, double-blind, placebo-controlled, parallel group study is evaluating the efficacy and safety profile of barzolvolimab in patients with moderate to severe AD. Topline data from this study are expected to be presented in late 2026. Novel Bispecific Antibody Platform CDX-622 – Bispecific SCF & TSLP CDX-622 targets two complementary pathways that drive chronic inflammation, potently neutralizing the alarmin thymic stromal lymphopoietin (TSLP) and depleting mast cells via stem cell factor (SCF) starvation. Combined neutralization of SCF and TSLP with CDX-622 is expected to simultaneously reduce tissue mast cells and inhibit Type 2 inflammatory responses to potentially offer enhanced therapeutic benefit in inflammatory and fibrotic disorders. CDX-622 has been engineered to disable effector function (AQQ) and enhance half-life (YTE). Enrollment is complete in the Phase 1 study in healthy volunteers. The Phase 1a clinical trial is a three-part, randomized, double-blind, placebo-controlled, dose escalation study designed to assess the safety, pharmacokinetics, and pharmacodynamics of CDX-622 in up to 80 healthy participants (Part 1: single intravenous (IV) dose, Part 2: 4 IV doses, Part 3: single subcutaneous (SubQ) dose). Positive data from the single ascending dose portion of the study was presented in October 2025. Data from the multiple ascending dose portion of the study and SubQ administration are anticipated in the third quarter of 2026. The pharmacodynamic biomarkers from blood and skin will be highly informative on the ability of CDX-622 to engage and neutralize SCF and TSLP. In January 2026, we initiated an open-label, single-dose Phase 1 proof of mechanism (POM) study to assess the safety, pharmacodynamics, and pharmacokinetics of CDX-622 in adults with mild to moderate asthma. Participants will receive a single IV infusion of CDX-622 and be followed for 12 weeks. PD effects of CDX-622 on fractional exhaled nitric oxide (FeNO), absolute eosinophil count (AEC) and serum biomarkers, including TSLP- and SCF-related biomarkers, will be evaluated. Fourth Quarter and Twelve Months 2025 Financial Highlights and 2026 Guidance Cash Position: Cash, cash equivalents and marketable securities as of December 31, 2025 were $518.6 million compared to $583.2 million as of September 30, 2025. The decrease was primarily driven by fourth quarter cash used in operating activities of $63.9 million. The increase in cash used in operating activities in the fourth quarter was primarily driven by higher clinical expenses, including the accelerated enrollment completion of the Phase 3 CSU program, and manufacturing barzolvolimab expenses. At December 31, 2025, Celldex had 66.5 million shares outstanding. Revenues: Total revenue was $0.1 million in the fourth quarter of 2025 and $1.5 million for the year ended December 31, 2025, compared to $1.2 million and $7.0 million for the comparable periods in 2024. The decrease in revenue was primarily due to a decrease in services performed under our manufacturing and research and development agreements with Rockefeller University. R&D Expenses: Research and development (R&D) expenses were $75.3 million in the fourth quarter of 2025 and $245.1 million for the year ended December 31, 2025, compared to $46.9 million and $163.6 million for the comparable periods in 2024. The increase in R&D expenses was primarily due to an increase in barzolvolimab clinical trial and contract manufacturing expenses and an increase in employee headcount. G&A Expenses: General and administrative (G&A) expenses were $11.9 million in the fourth quarter of 2025 and $43.8 million for the year ended December 31, 2025, compared to $10.3 million and $38.5 million for the comparable periods in 2024. The increase in G&A expenses was primarily due to an increase in employee headcount and an increase in barzolvolimab commercial planning expenses. Net Loss: Net loss was $81.3 million, or ($1.22) per share, for the fourth quarter of 2025, and $258.8 million, or ($3.90) per share, for the year ended December 31, 2025, compared to a net loss of $47.1 million, or ($0.71) per share, for the fourth quarter of 2024, and $157.9 million, or ($2.45) per share, for the year ended December 31, 2024. Financial Guidance: Celldex believes that the cash, cash equivalents and marketable securities at December 31, 2025 are sufficient to meet estimated working capital requirements and fund current planned operations through 2027. About Celldex Celldex is pioneering new horizons in immunology to deliver life-changing therapies. We are relentless in our pursuit of novel antibody-based treatments that engage the human immune system and directly affect critical pathways to improve the lives of patients with allergic, inflammatory and autoimmune disorders. Visit www.celldex.com. Forward-Looking Statement This release contains "forward-looking statements" made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. These statements are typically preceded by words such as "believes," "expects," "anticipates," "intends," "will," "may," "should," or similar expressions. These forward-looking statements reflect management's current knowledge, assumptions, judgment and expectations regarding future performance or events. Although management believes that the expectations reflected in such statements are reasonable, they give no assurance that such expectations will prove to be correct or that those goals will be achieved, and you should be aware that actual results could differ materially from those contained in the forward-looking statements. Forward-looking statements are subject to a number of risks and uncertainties, including, but not limited to, our ability to successfully complete research and further development and commercialization of Company drug candidates, including barzolvolimab (also referred to as CDX-0159) and CDX-622, in current or future indications; the uncertainties inherent in clinical testing and accruing patients for clinical trials; our limited experience in bringing programs through Phase 3 clinical trials; our ability to manage and successfully complete multiple clinical trials and the research and development efforts for our multiple products at varying stages of development; the availability, cost, delivery and quality of clinical materials produced by our own manufacturing facility or supplied by contract manufacturers, who may be our sole source of supply; the timing, cost and uncertainty of obtaining regulatory approvals; the failure of the market for the Company's programs to continue to develop; our ability to protect the Company's intellectual property; the loss of any executive officers or key personnel or consultants; competition; changes in the regulatory landscape or the imposition of regulations that affect the Company's products; our ability to continue to obtain capital to meet our long-term liquidity needs on acceptable terms, or at all, including the additional capital which will be necessary to complete the clinical trials that we have initiated or plan to initiate; and other factors listed under "Risk Factors" in our annual report on Form 10-K and quarterly reports on Form 10-Q. All forward-looking statements are expressly qualified in their entirety by this cautionary notice. You are cautioned not to place undue reliance on any forward-looking statements, which speak only as of the date of this release. We have no obligation, and expressly disclaim any obligation, to update, revise or correct any of the forward-looking statements, whether as a result of new information, future events or otherwise. Company Contact Sarah Cavanaugh Senior Vice President, Corporate Affairs & Administration (508) 864-8337 [email protected] Patrick Till Meru Advisors (484) 788-8560 [email protected]