Part I — Financial Information This section presents the company's unaudited financial statements and management's discussion and analysis for the reporting period [Item 1. Unaudited Financial Statements](index=4&type=section&id=Item%201.%20Unaudited%20Financial%20Statements) Celldex Therapeutics, Inc. presents its unaudited condensed consolidated financial statements for the period ended June 30, 2025, including balance sheets, statements of operations and comprehensive loss, and cash flows, along with detailed notes on accounting policies, segment information, fair value measurements, and specific financial line items. The company reported a net loss of $110.4 million for the six months ended June 30, 2025, and maintains sufficient liquidity to fund operations through 2027 [Condensed Consolidated Balance Sheets](index=4&type=section&id=Condensed%20Consolidated%20Balance%20Sheets) This section presents the company's financial position at specific dates, detailing assets, liabilities, and equity Condensed Consolidated Balance Sheet Highlights (In thousands) | Item | June 30, 2025 | December 31, 2024 | Change ($) | Change (%) | | :-------------------------------- | :------------ | :---------------- | :--------- | :--------- | | Cash and cash equivalents | $23,044 | $28,356 | $(5,312) | -18.7% | | Marketable securities | $607,293 | $696,925 | $(89,632) | -12.9% | | Total current assets | $648,404 | $747,159 | $(98,755) | -13.2% | | Total assets | $692,407 | $792,340 | $(99,933) | -12.6% | | Total current liabilities | $32,963 | $39,501 | $(6,538) | -16.5% | | Total liabilities | $37,001 | $45,335 | $(8,334) | -18.4% | | Total stockholders' equity | $655,406 | $747,005 | $(91,599) | -12.3% | [Condensed Consolidated Statements of Operations and Comprehensive Loss](index=5&type=section&id=Condensed%20Consolidated%20Statements%20of%20Operations%20and%20Comprehensive%20Loss) This section outlines the company's financial performance over specific periods, including revenues, expenses, and net loss Condensed Consolidated Statements of Operations and Comprehensive Loss (In thousands, except per share amounts) | Item | Three Months Ended June 30, 2025 | Three Months Ended June 30, 2024 | Six Months Ended June 30, 2025 | Six Months Ended June 30, 2024 | | :------------------------------------------ | :------------------------------- | :------------------------------- | :----------------------------- | :----------------------------- | | Total revenues | $730 | $2,498 | $1,424 | $2,654 | | Research and development expenses | $54,196 | $39,687 | $106,810 | $71,348 | | General and administrative expenses | $10,391 | $9,128 | $21,211 | $18,231 | | Total operating expenses | $64,587 | $48,815 | $128,021 | $89,579 | | Operating loss | $(63,857) | $(46,317) | $(126,597) | $(86,925) | | Investment and other income, net | $7,257 | $10,475 | $16,201 | $18,275 | | Net loss | $(56,600) | $(35,842) | $(110,396) | $(68,650) | | Basic and diluted net loss per common share | $(0.85) | $(0.54) | $(1.66) | $(1.10) | | Comprehensive loss | $(56,829) | $(36,306) | $(110,371) | $(70,178) | [Condensed Consolidated Statements of Cash Flows](index=6&type=section&id=Condensed%20Consolidated%20Statements%20of%20Cash%20Flows) This section details the company's cash inflows and outflows from operating, investing, and financing activities Condensed Consolidated Statements of Cash Flow (In thousands) | Item | Six Months Ended June 30, 2025 | Six Months Ended June 30, 2024 | | :------------------------------------------ | :----------------------------- | :----------------------------- | | Net cash used in operating activities | $(98,377) | $(69,965) | | Net cash provided by (used in) investing activities | $92,800 | $(361,934) | | Net cash provided by financing activities | $265 | $439,824 | | Net (decrease) increase in cash and cash equivalents | $(5,312) | $7,925 | | Cash and cash equivalents at end of period | $23,044 | $42,739 | [Notes to Unaudited Condensed Consolidated Financial Statements](index=7&type=section&id=Notes%20to%20Unaudited%20Condensed%20Consolidated%20Financial%20Statements) The notes provide critical context to the financial statements, detailing the basis of presentation, significant accounting policies, segment information, fair value measurements, and specific financial line items. They also cover stock-based compensation, revenue recognition, income taxes, net loss per share, and the settlement agreement related to the Kolltan acquisition [(1) Basis of Presentation](index=7&type=section&id=(1)%20Basis%20of%20Presentation) This note explains the foundational principles and assumptions underlying the preparation of the financial statements - At June 30, 2025, the Company had cash, cash equivalents and marketable securities of **$630.3 million**[15](index=15&type=chunk) - The Company incurred a **net loss of $110.4 million** and used **$98.4 million in cash from operations** for the six months ended June 30, 2025[15](index=15&type=chunk) - The Company believes current liquidity is sufficient to meet estimated working capital requirements and fund planned operations for at least the next twelve months, but may need to raise additional capital for long-term liquidity needs through licensing, business combinations, debt, or equity issuance[15](index=15&type=chunk)[16](index=16&type=chunk) [(2) Significant Accounting Policies](index=8&type=section&id=(2)%20Significant%20Accounting%20Policies) This note details the key accounting principles and methods used in preparing the financial statements - Significant accounting policies are consistent with those discussed in the Company's Annual Report on Form 10-K for the year ended December 31, 2024[17](index=17&type=chunk) - The Company is evaluating the impact of ASU 2023-09 (Income Taxes) and ASU 2024-03 (Expense Disaggregation Disclosures), effective for fiscal years beginning after December 15, 2024, and December 15, 2026, respectively[19](index=19&type=chunk)[20](index=20&type=chunk) [(3) Segment Information](index=8&type=section&id=(3)%20Segment%20Information) This note provides financial data and insights into the company's operating segments and their performance - The Company is managed as a single operating and reportable segment focused on the development, manufacturing, and commercialization of novel therapeutics[21](index=21&type=chunk) Research and Development Expenses by Program (In thousands) | Program | Three Months Ended June 30, 2025 | Three Months Ended June 30, 2024 | Six Months Ended June 30, 2025 | Six Months Ended June 30, 2024 | | :-------------------------- | :------------------------------- | :------------------------------- | :----------------------------- | :----------------------------- | | Barzolvolimab/Anti-KIT Program | $42,645 | $30,472 | $82,348 | $54,250 | | CDX-622 | $3,838 | $3,126 | $9,289 | $6,547 | | Other Programs | $7,713 | $6,089 | $15,173 | $10,551 | | **Total R&D Expense** | **$54,196** | **$39,687** | **$106,810** | **$71,348** | Research and Development Expenses by Nature (In thousands) | Expense Type | Three Months Ended June 30, 2025 | Three Months Ended June 30, 2024 | Six Months Ended June 30, 2025 | Six Months Ended June 30, 2024 | | :------------------- | :------------------------------- | :------------------------------- | :----------------------------- | :----------------------------- | | Personnel | $14,129 | $11,881 | $27,729 | $23,321 | | Laboratory supplies | $1,544 | $1,615 | $3,712 | $2,923 | | Facility | $1,398 | $1,250 | $2,803 | $2,536 | | Product development | $33,536 | $22,667 | $65,702 | $38,192 | | Other expenses | $3,589 | $2,274 | $6,864 | $4,376 | | **Total R&D Expense** | **$54,196** | **$39,687** | **$106,810** | **$71,348** | [(4) Fair Value Measurements](index=9&type=section&id=(4)%20Fair%20Value%20Measurements) This note describes the valuation techniques and inputs used to measure financial assets and liabilities at fair value - The Company's financial assets, primarily money market funds, cash equivalents, and marketable securities, are classified as Level 2 within the valuation hierarchy, totaling **$620.1 million** at June 30, 2025, and **$706.9 million** at December 31, 2024[26](index=26&type=chunk) - Contingent consideration liabilities measured at fair value using Level 3 inputs were **$0.0 million** at both June 30, 2025, and December 31, 2024, with no gain or loss on fair value remeasurement recorded[27](index=27&type=chunk)[28](index=28&type=chunk) [(5) Marketable Securities](index=11&type=section&id=(5)%20Marketable%20Securities) This note details the company's investment in marketable debt securities, including fair values and unrealized gains/losses Marketable Debt Securities (Available-for-Sale, In thousands) | Item | June 30, 2025 Fair Value | December 31, 2024 Fair Value | | :----------------------------------- | :----------------------- | :----------------------- | | U.S. government and municipal obligations | $254,348 | $288,358 | | Corporate debt securities | $352,945 | $408,567 | | **Total marketable securities** | **$607,293** | **$696,925** | Unrealized Loss Position (In thousands) | Item | June 30, 2025 | December 31, 2024 | | :------------------------------------------------ | :------------ | :---------------- | | Aggregate fair value of marketable securities in unrealized loss position | $153,200 | $142,500 | - Unrealized losses are generally attributable to changes in interest rates, and the Company has the intent and ability to hold these securities until recovery, determining no material credit loss at June 30, 2025[30](index=30&type=chunk) [(6) Intangible Assets](index=11&type=section&id=(6)%20Intangible%20Assets) This note provides information on the company's intangible assets, primarily acquired in-process research and development - The carrying value of indefinite-lived intangible assets, primarily acquired in-process research and development (IPR&D) related to the anti-KIT program (including barzolvolimab), remained at **$27.2 million** at June 30, 2025, and December 31, 2024[32](index=32&type=chunk) - Barzolvolimab is in Phase 3 development, and the IPR&D asset has not yet reached technological feasibility nor had alternative future uses[32](index=32&type=chunk) [(7) Other Assets](index=13&type=section&id=(7)%20Other%20Assets) This note describes other non-current assets held by the company, such as long-term advance payments - Advance payments for services not performed within one year, recorded as other assets, were **$9.2 million** at June 30, 2025, down from **$9.6 million** at December 31, 2024[34](index=34&type=chunk) [(8) Other Long-Term Liabilities](index=13&type=section&id=(8)%20Other%20Long-Term%20Liabilities) This note details the company's long-term obligations, including deferred tax liabilities and deferred revenue Other Long-Term Liabilities (In thousands) | Item | June 30, 2025 | December 31, 2024 | | :------------------------------------ | :------------ | :---------------- | | Net deferred tax liabilities related to IPR&D | $1,613 | $1,613 | | Deferred income from sale of tax benefits | $1,860 | $2,790 | | Deferred revenue | $— | $12 | | **Total** | **$3,473** | **$4,415** | | Less current portion | $(930) | $(942) | | **Long-term portion** | **$2,543** | **$3,473** | - The Company recognized **$0.9 million** in other income from the sale of New Jersey tax benefits for both the six months ended June 30, 2025, and June 30, 2024[35](index=35&type=chunk) [(9) Stockholders' Equity](index=13&type=section&id=(9)%20Stockholders'%20Equity) This note outlines changes in the company's equity, including common stock, additional paid-in capital, and accumulated deficit - Total stockholders' equity decreased from **$747.0 million** at December 31, 2024, to **$655.4 million** at June 30, 2025[40](index=40&type=chunk) - Common stock shares outstanding increased from **66,374,549** at December 31, 2024, to **66,394,241** at June 30, 2025[7](index=7&type=chunk) - In March 2024, the Company issued **9,798,000 shares of common stock** in an underwritten public offering, resulting in net proceeds of **$432.3 million**[38](index=38&type=chunk) [(10) Stock-Based Compensation](index=15&type=section&id=(10)%20Stock-Based%20Compensation) This note explains the accounting for stock options and other equity awards granted to employees and directors Stock-Based Compensation Expense (In thousands) | Expense Category | Three Months Ended June 30, 2025 | Three Months Ended June 30, 2024 | Six Months Ended June 30, 2025 | Six Months Ended June 30, 2024 | | :------------------------------ | :------------------------------- | :------------------------------- | :----------------------------- | :----------------------------- | | Research and development | $4,882 | $3,884 | $9,467 | $7,577 | | General and administrative | $4,309 | $3,756 | $9,040 | $7,265 | | **Total stock-based compensation expense** | **$9,191** | **$7,640** | **$18,507** | **$14,842** | - Options outstanding at June 30, 2025, were **9,290,328**, with a weighted average exercise price of **$26.55** and a remaining contractual term of **7.5 years**[41](index=41&type=chunk) - Total unrecognized compensation cost related to non-vested stock options was approximately **$81.9 million** as of June 30, 2025, expected to be recognized over a weighted average period of **2.9 years**[42](index=42&type=chunk) [(11) Accumulated Other Comprehensive Income](index=16&type=section&id=(11)%20Accumulated%20Other%20Comprehensive%20Income) This note details the components of comprehensive income not included in net income, such as unrealized gains or losses - Accumulated other comprehensive income increased from **$3.31 million** at December 31, 2024, to **$3.34 million** at June 30, 2025, primarily due to an unrealized gain on marketable securities of **$25 thousand**[44](index=44&type=chunk) [(12) Revenue](index=16&type=section&id=(12)%20Revenue) This note provides a breakdown of the company's revenue sources and the factors influencing their changes Contracts and Grants Revenue (In thousands) | Period | 2025 | 2024 | | :------------------------------- | :--- | :--- | | Three Months Ended June 30, | $723 | $2,498 | | Six Months Ended June 30, | $1,367 | $2,652 | - The decrease in contracts and grants revenue was primarily due to a decrease in services performed under agreements with Rockefeller University[45](index=45&type=chunk) [(13) Income Taxes](index=16&type=section&id=(13)%20Income%20Taxes) This note explains the company's income tax position, including deferred tax assets and liabilities and valuation allowances - The Company maintains a full valuation allowance on its net deferred tax assets due to a history of recurring losses[47](index=47&type=chunk) - A net deferred tax liability of **$1.6 million** at June 30, 2025, and December 31, 2024, relates to IPR&D intangible assets acquired in previous business combinations[48](index=48&type=chunk) - The Company will evaluate the impact of the newly enacted One Big Beautiful Bill Act (OBBBA) on its forecasted annual effective tax rate in subsequent periods[49](index=49&type=chunk) [(14) Net Loss Per Share](index=17&type=section&id=(14)%20Net%20Loss%20Per%20Share) This note details the calculation of basic and diluted net loss per common share, considering outstanding equity instruments - Basic and diluted net loss per common share were **$(1.66)** for the six months ended June 30, 2025, and **$(1.10)** for the same period in 2024[9](index=9&type=chunk) - Potentially dilutive common shares (stock options) were **9,290,328** in 2025 and **7,533,223** in 2024, but were excluded from diluted net loss per share calculations as their effect would have been anti-dilutive due to the net loss[50](index=50&type=chunk) [(15) Kolltan Acquisition](index=17&type=section&id=(15)%20Kolltan%20Acquisition) This note describes the settlement agreement related to the Kolltan acquisition, including milestone payments - A definitive settlement agreement in July 2022 replaced the original contingent consideration of up to **$172.5 million** from the Kolltan acquisition[54](index=54&type=chunk)[55](index=55&type=chunk) - The Company paid **$15.0 million** upon execution of the Settlement Agreement and **$12.5 million** upon successful completion of a Phase 2 Clinical Trial of barzolvolimab in November 2023[54](index=54&type=chunk)[56](index=56&type=chunk) - A future milestone payment of **$52.5 million** is due upon the first regulatory approval of a Surviving Company Product, payable at the Company's sole election in cash, stock, or a combination[54](index=54&type=chunk)[57](index=57&type=chunk) [Item 2. Management's Discussion and Analysis of Financial Condition and Results of Operations](index=19&type=section&id=Item%202.%20Management's%20Discussion%20and%20Analysis%20of%20Financial%20Condition%20and%20Results%20of%20Operations) This section discusses Celldex's financial condition and results of operations, highlighting its focus on developing therapeutic antibodies for inflammatory, allergic, and autoimmune diseases. It details the progress of key clinical programs, including barzolvolimab in multiple urticaria and dermatological conditions, and the bispecific antibody CDX-622. The company reported increased net losses and R&D expenses due to expanded clinical development, while also outlining its liquidity position and future capital needs [Overview](index=21&type=section&id=OVERVIEW) This section provides a strategic overview of Celldex's business, therapeutic focus, and development goals - Celldex is a biopharmaceutical company focused on mast cell biology and developing therapeutic antibodies for severe inflammatory, allergic, autoimmune, and other devastating diseases[62](index=62&type=chunk) - The Company's primary drug candidates include Barzolvolimab (CDX-0159) for mast cell-driven diseases (Chronic Urticarias, Prurigo Nodularis, Eosinophilic Esophagitis, Atopic Dermatitis) and CDX-622, a bispecific antibody for inflammatory diseases[64](index=64&type=chunk)[69](index=69&type=chunk) - The Company's goal is to build a fully integrated, commercial-stage biopharmaceutical company, with strategic options to retain full economic rights or seek advantageous commercial partnerships for its innovative therapies[66](index=66&type=chunk) [Clinical Development Programs](index=25&type=section&id=Clinical%20Development%20Programs) Celldex is actively advancing its clinical pipeline, with barzolvolimab progressing into Phase 3 for Chronic Spontaneous Urticaria (CSU) and showing promising Phase 2 results in Chronic Inducible Urticaria (CIndU), Prurigo Nodularis (PN), Eosinophilic Esophagitis (EoE), and Atopic Dermatitis (AD). The company is also developing CDX-622, a bispecific antibody, with a Phase 1 study initiated in healthy volunteers [Barzolvolimab (CDX-0159)](index=25&type=section&id=Barzolvolimab%20(CDX-0159)) This section details the clinical development progress of barzolvolimab across various inflammatory and autoimmune conditions [Chronic Spontaneous Urticaria (CSU)](index=26&type=section&id=Chronic%20Spontaneous%20Urticaria%20(CSU)) This section outlines the clinical trial progress and results for barzolvolimab in treating Chronic Spontaneous Urticaria - Initiated two Phase 3 studies (EMBARQ-CSU1 and EMBARQ-CSU2) in CSU in July 2024, with enrollment expected to be completed in summer 2026[97](index=97&type=chunk) - Phase 2 study in CSU achieved the primary efficacy endpoint (statistically significant mean change from baseline to Week 12 of UAS7 compared to placebo) and demonstrated sustained, deepening disease efficacy and a well-tolerated long-term safety profile through 76 weeks post-dosing[78](index=78&type=chunk)[90](index=90&type=chunk)[95](index=95&type=chunk)[99](index=99&type=chunk) Phase 2 CSU: Summary of Clinical Activity Assessments at Week 12 (UAS7, HSS7, ISS7 Changes) | Metric | 300 mg Q8W (n=51) | 150 mg Q4W (n=52) | 75 mg Q4W (n=53) | Placebo (n=51) | | :-------------------------------- | :---------------- | :---------------- | :--------------- | :------------- | | Baseline UAS7 (mean) | 31.33 | 30.75 | 30.30 | 30.09 | | LS Mean change at Week 12 (UAS7) | -23.87 (p<0.0001) | -23.02 (p<0.0001) | -17.06 (p=0.0017) | -10.47 | | UAS7=0 (Complete Control) at Week 12 | 37.5% | 51.1% | 22.9% | 6.4% | | UAS7≤6 (Well-controlled) at Week 12 | 62.5% | 59.6% | 41.7% | 12.8% | Phase 2 CSU: Summary of Clinical Activity Assessments at Week 76 (Post-Dosing) | Metric | 150 mg Q4W | 300 mg Q8W | | :-------------------------------- | :--------- | :--------- | | UAS7 mean change from baseline | -20.42 | -21.10 | | UAS7=0 (Complete Control) | 41% | 35% | | UAS7≤6 (Well-controlled) | 56% | 47% | | No impact on quality of life (DLQI) | 48% | 40% | [Chronic Inducible Urticaria (CIndU)](index=33&type=section&id=Chronic%20Inducible%20Urticaria%20(CIndU)) This section presents the clinical trial progress and results for barzolvolimab in treating Chronic Inducible Urticaria - Phase 2 study in CIndU achieved the primary efficacy endpoint in July 2024, showing a statistically significant difference in the percentage of patients with a negative provocation test compared to placebo at Week 12[78](index=78&type=chunk)[108](index=108&type=chunk) - All secondary endpoints, including improvements in Critical Temperature and Critical Friction Thresholds, and Urticaria Control Test, were also met and were highly statistically significant and clinically meaningful[78](index=78&type=chunk)[108](index=108&type=chunk)[109](index=109&type=chunk) - The Company plans to advance CIndU into Phase 3 registrational development based on these results[112](index=112&type=chunk) Phase 2 CIndU: Summary of Clinical Assessments at Week 12 | Metric | Cold Urticaria 150 mg q4w (n=32) | Cold Urticaria 300 mg q8w (n=32) | Cold Urticaria Placebo (n=32) | Symptomatic Dermographism 150 mg q4w (n=33) | Symptomatic Dermographism 300 mg q8w (n=33) | Symptomatic Dermographism Placebo (n=31) | | :------------------------------------------ | :------------------------------- | :------------------------------- | :---------------------------- | :------------------------------------------ | :------------------------------------------ | :---------------------------------------- | | % of patients with negative provocation test | 46.9% (p=0.0023) | 53.1% (p=0.0011) | 12.5% | 57.6% (p<0.0001) | 42.4% (p=0.0003) | 3.2% | | Improvement in Critical Temperature (CTT) / Critical Friction (CFT) Thresholds | -8.82°C (p<0.0001) | -9.61°C (p<0.0001) | -0.30°C | -2.46 pins (p<0.0001) | -2.27 pins (p=0.0002) | -0.82 pins | | % of patients with Urticaria Control Test >12 | 58.6% (p=0.0048) | 68.8% (p<0.0001) | 31.0% | 54.8% (p=0.0015) | 65.5% (p<0.0001) | 32.0% | [Prurigo Nodularis (PN)](index=37&type=section&id=Prurigo%20Nodularis%20(PN)) This section details the clinical trial progress and results for barzolvolimab in treating Prurigo Nodularis - Initiated a Phase 2 subcutaneous study in PN in April 2024, evaluating two dose levels of barzolvolimab against placebo in approximately 120 patients[119](index=119&type=chunk) - Phase 1b study showed a single IV dose of **3.0 mg/kg barzolvolimab** resulted in rapid and durable reductions in itch (**57% of patients with ≥4-point decrease in WI-NRS at Week 8**) and healing of skin lesions (**29% achieved clear or almost clear skin by IGA at Week 8**)[115](index=115&type=chunk)[116](index=116&type=chunk) - Clinical activity in PN was associated with profound serum tryptase reduction, indicative of mast cell depletion[117](index=117&type=chunk) [Eosinophilic Esophagitis (EoE)](index=39&type=section&id=Eosinophilic%20Esophagitis%20(EoE)) This section outlines the clinical trial progress and results for barzolvolimab in treating Eosinophilic Esophagitis - A Phase 2 study in EoE, initiated in June 2023, is fully enrolled, with data planned for presentation in the second half of 2025[69](index=69&type=chunk)[121](index=121&type=chunk) - The protocol was amended to dose **300 mg every 4 weeks** to optimize potential efficacy, with the primary endpoint being the reduction of esophageal intraepithelial infiltration of mast cells[121](index=121&type=chunk) [Atopic Dermatitis (AD)](index=39&type=section&id=Atopic%20Dermatitis%20(AD)) This section presents the clinical trial progress and results for barzolvolimab in treating Atopic Dermatitis - A Phase 2 study in moderate to severe AD was initiated in December 2024, with enrollment ongoing[69](index=69&type=chunk)[122](index=122&type=chunk)[123](index=123&type=chunk) - The study evaluates the efficacy and safety of subcutaneous barzolvolimab (**150 mg or 300 mg every 4 weeks**) compared to placebo, with the primary endpoint being the Peak Pruritus Numerical Rating Scale (PP-NRS) at Week 16[123](index=123&type=chunk) [Additional Barzolvolimab Development Activities](index=41&type=section&id=Additional%20Barzolvolimab%20Development%20Activities) This section covers manufacturing and toxicology updates for barzolvolimab, supporting its continued development - Successfully transferred manufacturing process to a CDMO and scaled up drug substance production for late-stage trials and potential commercialization, with drug product manufacturing into pre-filled syringes completed[124](index=124&type=chunk) - A six-month chronic toxicology study in non-human primates showed full recovery of spermatogenesis after a one-year recovery period, supporting continued development[125](index=125&type=chunk) [Bispecific Platform](index=41&type=section&id=Bispecific%20Platform) This section introduces the company's bispecific antibody platform and its lead candidate, CDX-622 [CDX-622](index=41&type=section&id=CDX-622) This section details the preclinical and early clinical development of CDX-622, a bispecific antibody for inflammatory diseases - CDX-622 is a bispecific antibody targeting TSLP and depleting mast cells via SCF starvation, designed to reduce tissue mast cells and inhibit Type 2 inflammatory responses[127](index=127&type=chunk) - A Phase 1a dose-escalation study in healthy volunteers was initiated in November 2024, with enrollment ongoing and data from Part 1 expected in the second half of 2025[128](index=128&type=chunk) - Preclinical studies showed CDX-622 inhibits TSLP and SCF with similar potency to parental mAbs, was well tolerated in toxicology studies, and led to profound mast cell depletion[127](index=127&type=chunk) [Critical Accounting Policies and Estimates](index=43&type=section&id=CRITICAL%20ACCOUNTING%20POLICIES%20AND%20ESTIMATES) This section highlights the key accounting policies and estimates that require significant management judgment - There have been no material changes to the Company's critical accounting policies or estimates since the Annual Report on Form 10-K for the year ended December 31, 2024[129](index=129&type=chunk) - Key critical accounting policies include accounting for contingent consideration, revenue recognition, intangible and long-lived assets, research and development expenses, and stock-based compensation expense[129](index=129&type=chunk) [Results of Operations](index=43&type=section&id=RESULTS%20OF%20OPERATIONS) Celldex experienced a significant increase in net loss for both the three and six months ended June 30, 2025, primarily driven by higher research and development expenses related to the expanded barzolvolimab clinical program. Revenue from contracts and grants decreased, while investment income also declined due to lower cash balances [Three Months Ended June 30, 2025 Compared with Three Months Ended June 30, 2024](index=43&type=section&id=Three%20Months%20Ended%20June%2030,%202025%20Compared%20with%20Three%20Months%20Ended%20June%2030,%202024) - Net loss increased by **$20.8 million (58%)** to **$(56.6) million**, primarily due to increased research and development expenses and decreased investment and other income, net[130](index=130&type=chunk)[131](index=131&type=chunk) - Total revenues decreased by **$1.8 million (71%)** to **$0.73 million**, mainly due to a decrease in contracts and grants revenue from Rockefeller University[130](index=130&type=chunk)[132](index=132&type=chunk) - Research and development expenses increased by **$14.5 million (37%)** to **$54.2 million**, primarily driven by higher personnel expenses (**19% increase**) and product development expenses (**48% increase**) due to barzolvolimab clinical trial and contract manufacturing[130](index=130&type=chunk)[133](index=133&type=chunk)[136](index=136&type=chunk) - General and administrative expenses increased by **$1.3 million (14%)** to **$10.4 million**, due to higher stock-based compensation and increased employee headcount[130](index=130&type=chunk)[137](index=137&type=chunk) - Investment and other income, net, decreased by **$3.2 million (31%)** to **$7.3 million**, primarily due to lower levels of cash and investment balances[130](index=130&type=chunk)[138](index=138&type=chunk) [Six Months Ended June 30, 2025 Compared with Six Months Ended June 30, 2024](index=46&type=section&id=Six%20Months%20Ended%20June%2030,%202025%20Compared%20with%20Six%20Months%20Ended%20June%2030,%202024) - Net loss increased by **$41.7 million (61%)** to **$(110.4) million**, primarily due to an increase in research and development expenses related to barzolvolimab[139](index=139&type=chunk)[141](index=141&type=chunk) - Total revenues decreased by **$1.2 million (46%)** to **$1.42 million**, mainly due to a decrease in contracts and grants revenue from Rockefeller University[139](index=139&type=chunk)[142](index=142&type=chunk) - Research and development expenses increased by **$35.5 million (50%)** to **$106.8 million**, driven by higher personnel (**19% increase**), laboratory supplies (**27% increase**), facility (**11% increase**), and product development (**72% increase**) costs, primarily for barzolvolimab clinical trials and manufacturing[139](index=139&type=chunk)[143](index=143&type=chunk)[144](index=144&type=chunk)[145](index=145&type=chunk)[146](index=146&type=chunk) - General and administrative expenses increased by **$3.0 million (16%)** to **$21.2 million**, due to higher stock-based compensation and increased employee headcount[139](index=139&type=chunk)[147](index=147&type=chunk) - Investment and other income, net, decreased by **$2.1 million (11%)** to **$16.2 million**, primarily due to lower levels of cash and investment balances[139](index=139&type=chunk)[148](index=148&type=chunk) [Liquidity and Capital Resources](index=48&type=section&id=LIQUIDITY%20AND%20CAPITAL%20RESOURCES) Celldex's liquidity at June 30, 2025, was $630.3 million in cash, cash equivalents, and marketable securities, which is deemed sufficient to fund operations through 2027. However, the company anticipates increased cash usage in operating activities due to expanded R&D and may seek additional capital through various means, including licensing, debt, or equity, which could be dilutive [Operating Activities](index=49&type=section&id=Operating%20Activities) This section details the cash flows generated from or used in the company's primary business operations - Net cash used in operating activities was **$98.4 million** for the six months ended June 30, 2025, an increase from **$70.0 million** in the prior year, primarily due to increases in research and development and general and administrative expenses[153](index=153&type=chunk) - The Company expects cash used in operating activities to increase over the next twelve months due to the expanded development of barzolvolimab[153](index=153&type=chunk) [Investing Activities](index=49&type=section&id=Investing%20Activities) This section describes the cash flows related to the purchase and sale of long-term assets and investments - Net cash provided by investing activities was **$92.8 million** for the six months ended June 30, 2025, a significant change from net cash used of **$361.9 million** in the prior year[155](index=155&type=chunk) - This increase was primarily due to net sales and maturities of marketable securities of **$93.8 million** in 2025, compared to net purchases of **$361.3 million** in 2024[155](index=155&type=chunk) [Financing Activities](index=49&type=section&id=Financing%20Activities) This section outlines the cash flows from activities involving debt, equity, and dividend payments - Net cash provided by financing activities decreased significantly to **$0.3 million** for the six months ended June 30, 2025, from **$439.8 million** in the prior year[156](index=156&type=chunk) - The decrease was primarily due to the absence of a large public offering in 2025, compared to **$432.3 million** in net proceeds from a common stock offering in March 2024[156](index=156&type=chunk) [Item 3. Quantitative and Qualitative Disclosures About Market Risk](index=50&type=section&id=Item%203.%20Quantitative%20and%20Qualitative%20Disclosures%20About%20Market%20Risk) Celldex's investment portfolio, primarily in money market funds and high-grade marketable securities, is managed to preserve capital and maintain liquidity. Due to the short-term nature of these investments, the company believes its exposure to market risk, particularly from interest rate changes, is not material, and it does not use derivative financial instruments - The Company's investment portfolio consists primarily of money market mutual funds, municipal bond securities, U.S. government agency securities, and high-grade corporate bonds, managed to preserve principal and maintain adequate liquidity[157](index=157&type=chunk) - Due to the short-term nature of these investments, the Company believes it does not have material exposure to market risk, and the impact from likely changes in interest rates is not material[157](index=157&type=chunk) - The Company does not utilize derivative financial instruments[158](index=158&type=chunk) [Item 4. Controls and Procedures](index=50&type=section&id=Item%204.%20Controls%20and%20Procedures) As of June 30, 2025, Celldex's management, including the CEO and CFO, concluded that the company's disclosure controls and procedures were effective at a reasonable assurance level. There were no material changes in internal control over financial reporting during the quarter - The Company's disclosure controls and procedures were evaluated and concluded to be effective at the reasonable assurance level as of June 30, 2025[159](index=159&type=chunk) - There were no changes in internal control over financial reporting during the quarter ended June 30, 2025, that have materially affected, or are reasonably likely to materially affect, internal control over financial reporting[160](index=160&type=chunk) Part II — Other Information This section covers other required disclosures including risk factors, other information, and exhibits [Item 1A. Risk Factors](index=51&type=section&id=Item%201A.%20Risk%20Factors) Celldex refers readers to the comprehensive discussion of risk factors in its Annual Report on Form 10-K for the year ended December 31, 2024. The company states that there were no material changes to these previously disclosed risk factors during the period covered by this quarterly report - No material changes to the risk factors previously disclosed in the Company's Annual Report on Form 10-K for the year ended December 31, 2024[163](index=163&type=chunk) [Item 5. Other Information](index=51&type=section&id=Item%205.%20Other%20Information) During the reporting period, no director or officer of Celldex Therapeutics, Inc. adopted or terminated any Rule 10b5-1 trading arrangements or non-Rule 10b5-1 trading arrangements - No director or officer of the Company adopted or terminated a "Rule 10b5-1 trading arrangement" or "non-Rule 10b5-1 trading arrangement" during the period covered by this Quarterly Report on Form 10-Q[164](index=164&type=chunk) [Item 6. Exhibits](index=51&type=section&id=Item%206.%20Exhibits) This section lists all exhibits filed as part of the Quarterly Report on Form 10-Q, which are incorporated by reference. These include certifications, XBRL documents, and an amendment to the equity incentive plan - Exhibits filed include Amendment No. 3 to Celldex Therapeutics, Inc. 2021 Omnibus Equity Incentive Plan, Certification of President and Chief Executive Officer, Certification of Senior Vice President and Chief Financial Officer, Section 1350 Certifications, and various Inline XBRL documents[167](index=167&type=chunk) [Signatures](index=52&type=section&id=Signatures) The Quarterly Report on Form 10-Q was duly signed on August 7, 2025, by Anthony S. Marucci, President and Chief Executive Officer, and Sam Martin, Senior Vice President and Chief Financial Officer, affirming compliance with the Securities Exchange Act of 1934 - The report was signed by Anthony S. Marucci, President and Chief Executive Officer, and Sam Martin, Senior Vice President and Chief Financial Officer[171](index=171&type=chunk) - The signing date for the report was August 7, 2025[171](index=171&type=chunk)

EXHIBIT 99.1 Celldex Reports Second Quarter 2025 Financial Results and Provides Corporate Update HAMPTON, N.J., Aug. 07, 2025 (GLOBE NEWSWIRE) -- Celldex Therapeutics, Inc. (NASDAQ:CLDX) today reported financial results for the second quarter ended June 30, 2025 and provided a corporate update. "In the second quarter of 2025, data from our now completed Phase 2 study in chronic spontaneous urticaria were presented that we believe clearly show that barzolvolimab is best in disease and achieves the goal of tr ...

Core Insights - Celldex Therapeutics announced that barzolvolimab significantly improves angioedema in chronic spontaneous urticaria (CSU) patients after 52 weeks of treatment [1][2][3] Group 1: Clinical Trial Results - The Phase 2 clinical trial met primary and secondary endpoints at 12 weeks, showing significant decreases in UAS7 scores compared to placebo [2][5] - At Week 52, an 86% mean reduction in angioedema activity was reported for the 150 mg Q4W group, and an 82% reduction for the 300 mg Q8W group [6] - 77% of patients treated with barzolvolimab who had angioedema at baseline were angioedema-free at Week 52 [5][6] Group 2: Patient Impact - The majority of patients with severe CSU experience painful angioedema, which significantly affects their quality of life [3][6] - 87% of patients reported clinically meaningful improvement in angioedema activity scores at Week 52 [6] Group 3: Drug Mechanism and Future Studies - Barzolvolimab is a humanized monoclonal antibody that targets the receptor tyrosine kinase KIT, which is involved in mast cell activation [4] - Celldex is conducting a global Phase 3 program for barzolvolimab in CSU, with enrollment currently underway [8]

Efficacy of Barzolvolimab - At Week 52, 71% of patients receiving 150 mg Q4W of barzolvolimab achieved a complete response in CSU, demonstrating the highest rate of complete response observed in a well-controlled study[16] - At Week 12, 51% of patients on the 150 mg Q4W dosage achieved complete response, compared to only 6% in the placebo group[16] - 7 months post-treatment (Week 76), 41% of patients in the 150 mg Q4W group sustained a complete response[16] - At Week 76, 47%-56% of barzolvolimab patients had well controlled disease[50] Safety and Tolerability - Barzolvolimab demonstrates a well-tolerated, long-term safety profile in Phase 2 trials[25] - Most adverse events are mild (Grade 1), KIT-mediated effects and reversible during follow-up period[27] - Localized hair color changes/lightening occurred in 48 patients through 52 weeks of treatment, with >90% already resolved at study closure[36] - Small areas of hypo-pigmentation occurred in 30 patients through 52 weeks of treatment, with >70% already resolved at study closure[36] Impact on Quality of Life - 92% of patients report moderate to high impact from CSU on their daily life[11] - At Week 76, 40%-48% of patients on barzolvolimab reported CSU had no impact (0-1) on their quality of life[53] - At Week 52, 82% of patients on the 150 mg Q4W dosage reported CSU had no impact (0-1) on their quality of life[57]

Summary of Celldex Therapeutics (CLDX) Conference Call Company Overview - **Company**: Celldex Therapeutics (CLDX) - **Focus**: Development of Barzolumab for chronic spontaneous urticaria (CSU) Key Industry Insights - **Industry**: Biopharmaceuticals, specifically targeting chronic spontaneous urticaria (CSU) - **Current Treatment Landscape**: Existing treatments are inadequate for many patients, highlighting the need for new options Core Findings from the Conference Call 1. **Barzolumab Phase II Study Results**: - Barzolumab shows the highest reported complete response rate in CSU treatment at every time point [7][12][30] - Complete response rates reached 51% at 12 weeks and 71% at 52 weeks, with 41% maintaining a complete response at 76 weeks post-treatment [30][31] - 93% of patients experienced a clinically meaningful reduction in disease burden during the active treatment period [12] 2. **Patient Quality of Life**: - 92% of patients report CSU impacts all aspects of their daily lives, with significant correlations between complete response and improved quality of life [11][36] - 48% of patients reported no impact on their daily quality of life seven months after treatment [35] 3. **Safety Profile**: - Barzolumab has a well-tolerated safety profile with no new safety signals identified during the follow-up period [20][28] - Common adverse events include mild decreases in neutrophil counts and subtle pigmentation changes, which are reversible [21][24] 4. **Market Potential**: - The drug is positioned as a potential first-line treatment for patients with antihistamine-refractory moderate to severe CSU [39] - High excitement among physicians regarding Barzolumab's efficacy and safety profile, which may influence treatment decisions [39] 5. **Ongoing Research and Development**: - Phase III studies are underway, with enrollment expected to complete by summer 2026 [39] - The company is focused on confirming the efficacy and safety of Barzolumab in larger patient populations [39] Additional Important Insights - **Patient Demographics**: The study included patients with severe CSU, with 70% having a UAS7 score greater than 28 at baseline [17] - **Long-term Efficacy**: The sustained response after treatment cessation suggests potential normalization of mast cell activity in patients [44] - **Physician Perspectives**: Physicians are optimistic about the potential for Barzolumab to change treatment paradigms for CSU, particularly for patients who have not responded to existing therapies [42][46] Conclusion - Celldex Therapeutics is making significant strides in the treatment of chronic spontaneous urticaria with Barzolumab, demonstrating promising efficacy and safety data that could redefine treatment standards in this area. The ongoing Phase III studies will be crucial in validating these findings and expanding treatment options for patients suffering from this debilitating condition.

Core Insights - Celldex announced new data showing significant and sustained complete response in chronic spontaneous urticaria (CSU) patients treated with barzolvolimab, with improvements in quality of life observed at 76 weeks post-treatment [1][2][3] Efficacy Data - The Phase 2 study met its primary endpoint, showing a significant improvement in UAS7 (weekly urticaria activity score) compared to placebo at 12 weeks across all dose groups [2][11] - At 12 weeks, up to 51% of patients achieved a complete response (UAS7=0), which increased to 71% at 52 weeks, and 41% maintained this response at 76 weeks [2][6] - 48% of patients reported that CSU no longer impacted their quality of life at 76 weeks, as measured by the Dermatology Life Quality Index (DLQI) [5][6] Safety Profile - Barzolvolimab demonstrated a well-tolerated safety profile throughout the study, with the most common adverse events being mild and reversible [7][3] - No new safety signals were identified, and neutropenia events resolved rapidly without association to infections [7][3] Future Developments - Enrollment for Phase 3 trials of barzolvolimab in CSU is ongoing, with two global Phase 3 trials designed to establish efficacy and safety in patients who remain symptomatic despite antihistamine treatment [12][11] - The company is focused on executing clinical trials to bring this potential new treatment to patients suffering from CSU [8][14]

Core Insights - Celldex will present data from its Phase 2 study of barzolvolimab for chronic spontaneous urticaria at the EAACI Congress 2025 in Glasgow, Scotland [1][2] - A webcast will be hosted by Celldex on June 12 at 6:00 pm ET to discuss the study data [1][2] - Key presentations include sustained disease control following withdrawal of barzolvolimab and improvement in angioedema in CSU patients [3] Company Information - Celldex is focused on developing novel antibody-based therapies that engage the human immune system to treat allergic, inflammatory, and autoimmune disorders [4] - The company emphasizes its commitment to pioneering advancements in immunology to improve patient outcomes [4] Event Details - The EAACI presentation session for the late-breaking oral presentation will occur on June 13 at 9:12 am BST [3] - The oral presentation on angioedema data will take place on June 14 at 3:48 pm BST [3] - The webcast will be accessible through the Investor Relations page of Celldex's website [2]

Core Insights - Celldex Therapeutics, Inc. has elected Denice M. Torres to its Board of Directors, bringing extensive leadership experience from the pharmaceutical and consumer healthcare sectors [1][2] - Torres expressed enthusiasm about joining Celldex at a pivotal time, highlighting the company's progress with barzolvolimab and its potential to improve treatment standards for patients [2] Company Overview - Celldex is a clinical stage biotechnology company focused on developing therapeutics that engage the human immune system to treat severe inflammatory, allergic, autoimmune, and other diseases [3]

Financial Performance - Celldex Therapeutics reported a quarterly loss of $0.81 per share, which was worse than the Zacks Consensus Estimate of a loss of $0.75, and compared to a loss of $0.56 per share a year ago, indicating a decline in performance [1] - The company posted revenues of $0.7 million for the quarter ended March 2025, missing the Zacks Consensus Estimate by 62.29%, while revenues a year ago were $0.16 million [2] - Over the last four quarters, Celldex has surpassed consensus EPS estimates three times and topped consensus revenue estimates two times [2] Stock Performance - Celldex shares have declined approximately 25.2% since the beginning of the year, contrasting with the S&P 500's decline of 4.3% [3] - The current Zacks Rank for Celldex is 3 (Hold), indicating that the shares are expected to perform in line with the market in the near future [6] Earnings Outlook - The current consensus EPS estimate for the upcoming quarter is -$0.81 on revenues of $1.84 million, and for the current fiscal year, it is -$3.38 on revenues of $7.33 million [7] - The estimate revisions trend for Celldex is mixed, and future earnings expectations will depend on management's commentary during the earnings call [3][4] Industry Context - The Medical - Biomedical and Genetics industry, to which Celldex belongs, is currently in the top 33% of over 250 Zacks industries, suggesting a favorable outlook compared to lower-ranked industries [8] - Empirical research indicates a strong correlation between near-term stock movements and trends in earnings estimate revisions, which can impact Celldex's stock performance [5]

Clinical Trials and Efficacy - Barzolvolimab (CDX-0159) achieved primary efficacy endpoints in Phase 2 studies for chronic spontaneous urticaria (CSU) and chronic inducible urticaria (CIndU), with statistically significant mean changes from baseline to week 12 compared to placebo[65]. - The company initiated Phase 3 studies in CSU in July 2024, following successful Phase 2 results, and plans to present follow-up data through week 76 in 2025[81]. - Ongoing Phase 2 studies for Barzolvolimab include eosinophilic esophagitis (EoE), prurigo nodularis (PN), and atopic dermatitis (AD), with enrollment ongoing for AD initiated in December 2024[73][82]. - The Phase 2 study in chronic inducible urticaria (CIndU) achieved all secondary endpoints, which were highly statistically significant and clinically meaningful[81]. - Barzolvolimab demonstrated a statistically significant mean change from baseline to week 12 in UAS7 compared to placebo at all dose levels, with a mean change of -23.87 for 300 mg Q8W, -23.02 for 150 mg Q4W, and -17.06 for 75 mg Q4W[92]. - At week 12, 37.5% of patients in the 300 mg group achieved complete control (UAS7=0), compared to 51.1% in the 150 mg group and 22.9% in the 75 mg group, while only 6.4% in the placebo group achieved the same[92]. - Approximately 72% of patients had angioedema at baseline, with barzolvolimab showing significant improvements in AAS7 across all doses at week 12, achieving a >8 point improvement compared to placebo[95]. - Long-term treatment data presented indicated sustained and deepening disease efficacy over a 52-week treatment period, with improved urticaria control and reduced disease impact on quality of life[96]. - The primary endpoint of the Phase 3 studies will evaluate the clinical effect of barzolvolimab in reducing urticaria activity (UAS7) at week 12[97]. - Barzolvolimab demonstrated a complete response in 71% of patients treated with 150 mg Q4W and 52% of patients treated with 300 mg Q8W at Week 52[98]. - 74% of patients treated with barzolvolimab 150 mg Q4W and 68% of patients treated with 300 mg Q8W had well-controlled disease (UAS7<6) at Week 52[98]. - In a Phase 1b trial, 95% of patients with ColdU and SD achieved a complete response with a single dose of 3 mg/kg[103]. - The median duration of complete response for ColdU patients was 77+ days, while for SD patients it was 57+ days[103]. - At Week 12, 46.9% of patients receiving 150 mg Q4W and 53.1% receiving 300 mg Q8W had a negative provocation test compared to 12.5% in the placebo group[108]. - The study reported a statistically significant improvement in Critical Temperature Threshold (CTT) of -8.82°C for 150 mg Q4W and -9.61°C for 300 mg Q8W[108]. - 58.6% of patients in the 150 mg Q4W group and 68.8% in the 300 mg Q8W group achieved Urticaria Control Test scores >12 at Week 12[108]. - In a Phase 1b study for Prurigo Nodularis (PN), 57% of patients receiving 3.0 mg/kg barzolvolimab achieved a ≥4-point decrease in Worst Itch-Numerical Rating Scale (WI-NRS) at week 8, compared to 25% in the placebo group[114]. - The study showed that 29% of patients on the 3.0 mg/kg dose achieved clear or almost clear skin according to Investigator Global Assessment (IGA) at week 8, with no patients in the placebo or 1.5 mg/kg groups achieving this[114]. - The company has initiated a Phase 2 study for Eosinophilic Esophagitis (EoE) with approximately 160,000 patients in the U.S. estimated to have undergone treatment in the last 12 months, of which about 48,000 are biologic-eligible[119]. - A Phase 2 study for Atopic Dermatitis (AD) has been initiated, targeting a population where two-thirds of patients do not achieve complete control with first-line systemic therapy, indicating a significant unmet need[121]. - The company plans to present data from the EoE study in the second half of 2025, with a focus on reducing esophageal intraepithelial mast cell count as the primary endpoint[120]. Financial Performance - Total research and development expenses for the three months ended March 31, 2025, were $52.614 million, compared to $31.661 million for the same period in 2024, reflecting a 66% increase[79]. - The company incurred an aggregate of $459.7 million in research and development expenses over the past five years through December 31, 2024[78]. - Total revenues for the three months ended March 31, 2025, were $695,000, a 346% increase compared to $156,000 for the same period in 2024[131]. - The net loss for the three months ended March 31, 2025, was $53.8 million, representing a 64% increase from a net loss of $32.8 million for the same period in 2024[132]. - Cash, cash equivalents, and marketable securities totaled $673.3 million as of March 31, 2025, sufficient to meet estimated working capital requirements through 2027[143]. - Net cash used in operating activities was $54.4 million for the three months ended March 31, 2025, compared to $40.6 million for the same period in 2024[145]. - Investment and other income increased by $1.1 million to $8.9 million for the three months ended March 31, 2025, compared to $7.8 million for the same period in 2024[140]. - Product development expenses surged by 107% to $32.2 million for the three months ended March 31, 2025, compared to $15.5 million for the same period in 2024[138]. - General and administrative expenses rose by 19% to $10.8 million for the three months ended March 31, 2025, compared to $9.1 million for the same period in 2024[139]. - The company expects revenue to decrease over the next twelve months due to a reduction in services under existing agreements[133]. - The company plans to raise additional capital through various means, including licensing drug candidates and possible business combinations[144]. Strategic Development - The company is focusing on developing a next-generation bispecific antibody platform, with CDX-622 as the first candidate targeting chronic inflammation pathways[73]. - The company emphasizes the importance of raising sufficient capital to fund ongoing clinical studies and meet long-term liquidity needs[64]. - The company plans to explore strategic partnerships to maximize the value of its technology and product portfolio while ensuring the expeditious development of each product[69]. - Barzolvolimab's manufacturing process has been successfully scaled up to produce larger cGMP batches in support of late-stage trials and potential commercialization[125]. - The company is developing CDX-622, a bispecific antibody targeting TSLP and SCF, which is expected to offer enhanced therapeutic benefits in inflammatory and fibrotic disorders[128]. - In the Phase 2 PN study, patients are being randomized to receive barzolvolimab injections of 150 mg or 300 mg every 4 weeks, with a total enrollment of approximately 120 patients[118]. - The Phase 2 study for AD will include up to 120 patients, with a primary endpoint of evaluating clinical efficacy using the Peak Pruritus Numerical Rating Scale (PP-NRS) at week 16[124]. - The company has expanded clinical development of barzolvolimab into PN, addressing a significant unmet need as there is currently only one FDA-approved therapy for this condition[112].