Barzolvolimab

HAMPTON, N.J., April 01, 2026 (GLOBE NEWSWIRE) -- Celldex Therapeutics, Inc. (“Celldex” or the “Company”) (Nasdaq: CLDX) today announced the pricing of an underwritten public offering of 10,345,000 shares of its common stock at a public offering price of $29.00 per share. All of the shares to be sold in the offering are to be sold by Celldex. In connection with the offering, Celldex has also granted the underwriters a 30-day option to purchase up to an additional 1,551,750 shares of common stock at the public offering price, less the underwriting discounts and commissions. The Company expects to receive gross proceeds from the offering, excluding the exercise of the underwriters’ option, if any, of approximately $300 million, excluding the underwriting discounts and commissions and other offering-related expenses. The offering is expected to close on or about April 6, 2026, subject to customary closing conditions. Celldex intends to use the net proceeds of this offering, together with our existing cash, cash equivalents, and marketable securities, (i) to fund ongoing commercial readiness activities and the commercial launch of barzolvolimab, if approved, for the treatment of CSU in the United States, (ii) to continue the clinical and preclinical development of our product candidates, including current and future development of barzolvolimab, (iii) to grow our bispecific antibody platform and clinical candidates, (iv) to fund ongoing efforts to develop additional clinical pipeline product candidates and (v) for general corporate purposes. Leerink Partners, TD Cowen, Guggenheim Securities and Cantor are acting as joint bookrunning managers for the offering. LifeSci Capital and H.C. Wainwright & Co. are acting as co-lead managers for the offering. The offering is being made pursuant to a shelf registration statement on Form S-3 (File No. 333-275300), which was previously filed with the Securities and Exchange Commission (“SEC”) and became automatically effective on November 3, 2023. This offering is being made only by means of a prospectus supplement and accompanying base prospectus that form a part of the registration statement. A preliminary prospectus supplement relating to and describing the terms of the offering has been filed with the SEC and may be obtained for free by visiting the SEC’s website at A final prospectus supplement relating to the offering will be filed with the SEC and will be available on the SEC’s website located at . When available, copies of the final prospectus supplement and the accompanying base prospectus may be obtained for free by contacting Leerink Partners LLC, Syndicate Department, 53 State Street, 40th Floor, Boston, MA 02109, or by telephone at (800) 808-7525 ext. 6105 or by email at syndicate@leerink.com or TD Securities (USA) LLC, c/o Broadridge Financial Solutions, 1155 Long Island Avenue, Edgewood, NY 11717 or by email at TDManualrequest@broadridge.com . This press release does not constitute an offer to sell or the solicitation of an offer to buy any of the securities described herein, nor shall there be any sale of these securities in any state or other jurisdiction in which such offer, solicitation or sale would be unlawful prior to the registration or qualification under the securities laws of any such state or other jurisdiction. About Celldex Celldex is a clinical stage biotechnology company leading the science at the intersection of mast cell biology and the development of transformative therapeutics for patients. Our pipeline includes antibody-based therapeutics which have the ability to engage the human immune system and/or directly affect critical pathways to improve the lives of patients with severe inflammatory, allergic, autoimmune and other devastating diseases. 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, risks associated with market conditions and the satisfaction of customary closing conditions related to the offering. For a further description of the risks and uncertainties that could cause actual results to differ from those expressed in these forward-looking statements, as well as risks relating to the Company’s business in general, please refer to the Company’s preliminary prospectus supplement filed with the SEC, and the documents incorporated by reference therein, including the Company’s Form 10-K for the year ended December 31, 2025. 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 Celldex Therapeutics, Inc. (508) 864-8337 scavanaugh@celldex.com Patrick Till Meru Advisors (484) 788-8560 ptill@meruadvisors.com

- Improvements seen across all six DLQI Domains indicating broad, beneficial impact on quality of life - - Data further demonstrates first-in-class and best-in-disease barzolvolimab profile - March 27, 2026 -- Celldex (NASDAQ:CLDX) presented additional positive data from the completed Phase 2 clinical trials of barzolvolimab in chronic spontaneous urticaria (CSU) and cold urticaria (ColdU) and symptomatic dermographism (SD) demonstrating profound improvements in patient quality of life (QoL) across all measured domains: symptoms and feelings, daily activities, leisure, work and school, personal relationships and treatment. Barzolvolimab is a humanized monoclonal antibody with a completely novel mechanism of action that uniquely targets the root cause of CSU, ColdU and SD—the mast cell. The data were presented at the 2026 Americal Academy of Dermatology (AAD) Annual Meeting being held March 27 – 31, 2026 in Denver, CO. “Chronic urticarias are devastating diseases of misery that cause immense physical and psychological suffering for patients across all aspects of their daily lives,” said Diane Young, MD, Senior Vice President and Chief Medical Officer of Celldex. “Patients are either directly dealing with intensely itchy, painful burning hives and swelling associated with angioedema or living in fear of their next outbreak. These diseases take an incredible toll on patient quality of life and, sadly, but not surprisingly, recent literature1 shows increased mortality for individuals with CSU as well as increased suicidal ideations and suicide attempts. We are gratified to see barzolvolimab’s profound clinical efficacy also translate to dramatic improvements in patient quality of life—offering new hope for patients and their physicians and supporting barzolvolimab’s profile as a best-in-class, best-in-disease potential treatment option for chronic urticarias.” Posters are available on the Celldex website. The Dermatology Life Quality Index2 (DLQI) measures impact of skin disease on quality of life, with a score of 0/1 indicating no effect of the disease on a patient’s life. Prolonged and Enhanced Quality of Life in Patients with Chronic Spontaneous Urticaria Treated with Barzolvolimab, M. Metz, et al As previously reported in the Phase 2 CSU study, up to 51% of patients on study experienced symptom free complete response (UAS7=0; no itch/no hives) at 12 weeks, which continued to deepen over 52 weeks of active therapy to up to 71% of patients. This profound clinical benefit continued even after patients were off therapy—up to 41% of patients reported complete response seven months after receiving their last dose of barzolvolimab. In the post hoc analysis presented at AAD, the impact of disease on QoL for the subset of patients who received 52 weeks of barzolvolimab therapy (150 mg Q4W or 300 mg Q8W) and completed treatment with at least well controlled disease (UAS76) at Week 52 and had DLQI data through Week 76 was explored. The vast majority of patients included in this analysis had substantial disease burden at baseline (68% had both severe disease and angioedema) and patients had CSU for a long time (6 years, mean). Patients reported that their CSU had a very large negative impact on their QoL (DLQI mean baseline score of 15.6). At Week 52, 94% of patients with well controlled disease at Week 52 also had a DLQI of 0/1, indicating their disease had no impact on their QoL . Barzolvolimab treatment led to prolonged, off-treatment enhanced QoL seven months after the last dose of barzolvolimab. At baseline, patients reported their CSU significantly impacted their QoL across all 6 DLQI domains (symptoms and feelings, daily activities, leisure, work and school, personal relationships, and treatment). Profound improvements were observed across all 6 domains at both Weeks 52 and 76. 76% of patients with well controlled disease at Week 52 also reported that the disease had small to no impact (DLQI score ≤ 5) on their QoL at Week 76. The majority of patients with well controlled disease at Week 52 achieved DLQI domain scores of 0/1 (no impact on QoL) at Week 76. This sustained off-treatment improvement in QoL was observed despite barzolvolimab clearance and normalization of tryptase (a measure of mast cell burden), suggesting disease modification and supports barzolvolimab’s significant potential to become a transformative treatment option for patients suffering from CSU. Treatment with Barzolvolimab Improves DLQI Scores in All Domains in Patients with Chronic Inducible Urticaria, M. Metz, et al As previously reported in the Phase 2 ColdU and SD study, up to 53% of patients with ColdU and 58% with SD achieved complete response (negative provocation test) at Week 12 (primary endpoint analysis) and up to 66% of patients with ColdU and 49% with SD achieved complete response at Week 20. Barzolvolimab treatment improved the QoL of patients with ColdU and SD throughout the 20-week treatment period. Mean DLQI improved from a very large effect of disease on QoL at baseline to a small effect of disease on QoL at Week 20. Benefits on QoL were rapid and apparent by the first DLQI measurement at Week 4 (300 mg Q8W). Barzolvolimab treatment increased the rate of achieving no impact of disease on QoL (DLQI of 0/1) at Week 20 by up to 3.1-fold in patients with ColdU and 4.0-fold in patients with SD vs placebo. Barzolvolimab treatment resulted in improvements across all six DLQI domains, indicating broad, beneficial effects on QoL. This Phase 2 study is the first large randomized, placebo-controlled study to demonstrate clinical benefit in patients with CIndU. References: 1Kolkhir P, Bieber K, Hawro T, et al. Mortality in adult patients with chronic spontaneous urticaria: A real-world cohort study. Journal of Allergy and Clinical Immunology, 2024; 155:1290-1298. 2Dermatology Life Quality Index (DLQI) consists of ten questions (on a scale of 0–3, total 0–30) used to measure the impact of skin disease on patient quality of life related to symptoms and feelings, daily activities, leisure, work and school, personal relationships, and treatment. DLQI 0–1 indicates no effect on a patient’s life. CSU is an underdiagnosed disease of misery marked by spontaneous hives, unbearable itch, and unpredictable episodes of disfiguring swelling (angioedema) that causes substantial mental health burden, profound impact on quality of life and is associated with a 1.7-fold increase in all cause mortality at 5 years. Mast cell activation plays a central role in the onset and progression of CSU. While the goal of CSU treatment is the complete absence of symptoms, the vast majority of patients today, even those receiving the most advanced approved and available therapies, continue to suffer from itch, hives, swelling, sleep disruption, and unrelenting anxiety about when the next flare up will occur. In February, Celldex announced the completion of enrollment in the Company’s global Phase 3 program in CSU. The Program, which fully accrued six months ahead of guidance, 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. Topline data from the studies are expected in the fourth quarter of 2026. CIndU is characterized by the occurrence of hives or wheals that have an attributable trigger associated with them. ColdU symptoms include itching, burning wheals/hives and angioedema when skin is exposed to cold temperatures. SD symptoms include the development of wheals in response to stroking, scratching or rubbing of the skin. For these diseases, mast cell activation leading to release of soluble mediators is thought to be the driving mechanism leading to the wheals and other symptoms. There are currently no approved therapies for chronic inducible urticarias other than antihistamines and patients attempt to manage symptoms associated with their disease through avoidance of triggers.I In December 2025, Celldex initiated a global Phase 3 study in cold urticaria (ColdU) and symptomatic dermographism (SD), EMBARQ-ColdU and -SD, and enrollment is ongoing. Barzolvolimab is a humanized monoclonal antibody with a completely 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. 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. The content above comes from the network. if any infringement, please contact us to modify.