Claseprubart

- Obexelimab BLA submission for the treatment of IgG4-RD accepted by FDA; PDUFA target action date of May 27, 2027 - - New study data confirm bioequivalence of obexelimab single-dose prefilled autoinjector pen compared to prefilled syringes - - Obexelimab global Phase 2 SunStone SLE trial topline results expected in Q4 2026 - - ZB021 (oral IL-17AA/AF inhibitor) dosing ongoing in Phase 1 trial; initial clinical data expected by year-end - - Four Orelabrutinib abstracts accepted for poster presentation at MSToronto 2026 - - Expanded Board of Directors with the appointment of Christy Oliger, who brings more than 30 years of global biopharmaceutical commercial and operating experience - - CFO to transition to Strategic Advisor to the Board Chair at the end of September - - Cash, cash equivalents and investments of $673.9 million as of June 30, 2026 - WALTHAM, Mass., Aug. 13, 2026 (GLOBE NEWSWIRE) -- Zenas BioPharma, Inc. (“Zenas” or the “Company”) (Nasdaq: ZBIO), a clinical-stage global biopharmaceutical company advancing therapies for patients living with autoimmune and inflammatory diseases, today reported financial results for the quarter ended June 30, 2026, and provided recent corporate updates. "2026 continues to be a transformative year for Zenas, highlighted by FDA acceptance of the obexelimab BLA for the treatment of IgG4-RD, with a PDUFA date of May 27, 2027. Our expanding team is actively preparing for the potential commercialization of our first product," said Lonnie Moulder, Founder and Chief Executive Officer of Zenas. "The strength of the Phase 3 INDIGO data for obexelimab in IgG4-RD was underscored by its selection as an oral presentation at EULAR and simultaneous publication in the New England Journal of Medicine . Beyond IgG4-RD, we are on track to report Phase 2 topline data for obexelimab in SLE and initial Phase 1 data for ZB021 by year-end. We continue to execute across our portfolio and make meaningful progress toward our vision of becoming a fully integrated, global development and commercial-stage biopharmaceutical company that brings impactful treatments to patients living with autoimmune and chronic inflammatory diseases." Corporate highlights Obexelimab, a CD19 and FcγRIIb inhibitor of B cell function In August, the U.S. Food and Drug Administration (FDA) accepted the Company’s Biologics License Application (BLA) for obexelimab for the treatment of Immunoglobulin G4-Related Disease (IgG4-RD): The BLA has a Prescription Drug User Fee Act (PDUFA) target action date of May 27, 2027. Zenas expects to submit a Marketing Authorization Application (MAA) to the European Medicines Agency (EMA) in the second half of 2026. Positive results from the Phase 3 INDIGO registrational trial of obexelimab for the treatment of IgG4-RD presented at EULAR and published in NEJM in June 2026: Additional data from the INDIGO trial presented at the European Alliance of Associations for Rheumatology (EULAR) 2026 Congress, and published online by the New England Journal of Medicine . Obexelimab met the primary endpoint, demonstrating a highly statistically significant and clinically meaningful 56% (HR 0.44; 95% CI 0.277–0.711; p=0.0005) reduction in the risk of IgG4-RD flare compared to placebo during the 52-week randomized placebo-controlled period. A majority of patients treated with obexelimab (73.2%) remained flare-free through Week 52, compared to fewer than half (45.4%) of placebo-treated patients. Obexelimab met and demonstrated highly statistically significant activity compared to placebo on all four key secondary endpoints and significantly lowered the total amount of glucocorticoid use and reduced glucocorticoid-related toxicities. Obexelimab was well tolerated, treatment-emergent adverse events (TEAEs) were similar between obexelimab and placebo-treated patients, and the incidence of Grade ≥3 TEAEs and infections were lower with obexelimab compared to placebo. More information on the Phase 3 INDIGO trial (NCT05662241) is available at clinicaltrials.gov. In August, our partner Bristol Myers Squibb announced they submitted a marketing authorization application to Japan's Pharmaceuticals and Medical Devices Agency (PMDA) for obexelimab for the treatment of IgG4-RD: The application is based on the results of the global Phase 3 INDIGO trial. BMS hold exclusive rights to develop, manufacture and commercialize obexelimab in Japan, South Korea, Taiwan, Singapore, Hong Kong and Australia. Bioequivalence established for obexelimab delivered via prefilled syringe versus prefilled pen: New clinical study data confirm bioequivalence between obexelimab delivered via prefilled syringe and single-dose prefilled pen. The single-dose prefilled pen has the potential to offer a more convenient delivery option for patients. Zenas intends to submit a supplemental application to obexelimab's IgG4-RD BLA, if approved, and to include the single-dose prefilled pen and bioequivalence data in a European MAA submission in the second half of 2026. Phase 2 SunStone trial in Systemic Lupus Erythematosus (SLE) topline results expected in 4Q 2026: Zenas anticipates reporting topline overall and biomarker population results in the fourth quarter of 2026. More information on the Phase 2 SunStone trial (NCT06559163) is available at clinicaltrials.gov. ZB021, a novel oral, IL-17AA/AF inhibitor that blocks IL-17 AA homodimer and IL-17AF heterodimer signaling Dosing ongoing in Phase 1 trial of ZB021 in healthy volunteers: Dosing is ongoing in the single ascending dose (SAD) and now, the multiple ascending dose (MAD) parts of the Phase 1 trial designed to evaluate the safety, tolerability, and pharmacokinetic pro ZB021 in healthy volunteers. The trial is being conducted in partnership with InnoCare Pharma in China. These data are expected by year-end 2026. Upon completion and evaluation of the SAD and MAD study, Zenas plans to initiate a proof-of-concept (POC) trial in North America to evaluate clinical activity and safety in psoriasis patients with results anticipated in 2027. Orelabrutinib, a highly selective CNS-penetrant Bruton’s Tyrosine Kinase (BTK) inhibitor Orelabrutinib Phase 3 PriMroSe Primary Progressive Multiple Sclerosis (PPMS) trial ongoing: PriMroSe, a Phase 3, global registration-directed, multicenter, randomized, double-blind, placebo-controlled trial to evaluate the efficacy and safety of orelabrutinib in patients with PPMS is ongoing. More information on the Phase 3 PriMroSe trial (NCT07067463) is available at clinicaltrials.gov. Orelabrutinib Phase 3 Monarch non-active Secondary Progressive Multiple Sclerosis (naSPMS) trial ongoing: Monarch, a Phase 3, global registration-directed, multicenter, randomized, double-blind, placebo-controlled trial to evaluate the efficacy and safety of orelabrutinib in patients with naSPMS is ongoing. More information on the Phase 3 Monarch trial (NCT07299019) is available at clinicaltrials.gov. Four abstracts accepted for MSToronto 2026 including 24-week data and pharmacokinetic analysis from the orelabrutinib Phase 2 relapsing remitting multiple sclerosis trial along with study designs for the Phase 3 Monarch and PriMroSe trials: Efficacy and Safety of Orelabrutinib in Relapsing-Remitting Multiple Sclerosis: 24-Week Results from a Phase 2 Randomized, Double-Blind, Placebo-Controlled Study. Pharmacokinetics of Orelabrutinib in a Phase 2 Study in Relapsing Remitting Multiple Sclerosis. Orelabrutinib in Non-Active Secondary Progressive Multiple Sclerosis: Design of the Monarch Phase 3 Randomized Controlled Trial. Orelabrutinib in Primary Progressive Multiple Sclerosis: Design of the PriMroSe Phase 3 Randomized Controlled Trial. Zenas to host industry-supported symposium at MSToronto 2026: Symposium entitled “BTK Inhibition in MS: An Emerging Therapeutic Approach to Disability Progression” to be chaired and moderated by Amit Bar-Or, MD, FRCP, FAAN, FANA Chief of the Multiple Sclerosis Division, Department of Neurology, Perelman School of Medicine at the University of Pennsylvania. Early development programs ZB022, an oral, brain-penetrant, TYK2-JH2 inhibitor IND enabling studies ongoing: Subject to the results of IND enabling studies, Zenas expects to initiate a Phase 1 clinical study in 2027. ZB014, a half-life extended, anti-CD19 and FcγRIIb monoclonal antibody (mAb) IND enabling studies ongoing : Developed using half-life extension technology for mAbs, and based on preclinical study results, ZB014 has the potential to provide the clinical activity and safety pro with obexelimab while offering a once-monthly dosing schedule. Zenas expects to advance the program into Phase 1 clinical development in 2027. Board of Directors Appointment In August 2026, Zenas appointed Christy Oliger to its Board of Directors. Ms. Oliger brings more than 30 years of commercial and operating experience across global biopharmaceutical organizations, including as Senior Vice President and Business Unit Head, Oncology at Genentech, where she led a portfolio of 15 products representing more than $13 billion in U.S. revenue, and as Senior Vice President and Business Unit Head, Neurology, Rare Disease and Infectious Disease, where she led the teams behind launches in multiple sclerosis, hemophilia and spinal muscular atrophy. She currently serves on the boards of directors of Bicara Therapeutics, Vera Therapeutics, Karyopharm Therapeutics and Replimune Inc., and previously served as a director of Nuvalent Inc., Sierra Oncology, Reata Pharmaceuticals, RayzeBio and LAVA Therapeutics. She began her career in life sciences at Schering-Plough and holds a B.A. in economics from the University of California, Santa Barbara. "We are pleased to welcome Christy to our Board of Directors as Zenas advances toward becoming a commercial-stage company," said Lonnie Moulder, Chief Executive Officer of Zenas BioPharma. "Christy has spent her career building the organizations and capabilities that bring important new medicines to patients and leading the business units behind multiple successful launches. She has since served as a director of numerous public late-stage clinical- and commercial-stage biotechnology companies. Her experience complements our board as we work to deliver potentially transformative therapies to patients with autoimmune and chronic inflammatory diseases." Leadership Transition The Company announced that Jennifer Fox will transition from her current role as Chief Financial Officer and Chief Business Officer to serve in a new role as Strategic Advisor to the Board Chair effective September 30th. Joe Farmer, President and COO, will serve as Principal Financial Officer and Principal Accounting Officer until the appointment of a Chief Financial Officer. “I would like to thank Jennifer Fox, who has played an instrumental role in the development and execution of our growth strategy over the past several years, as we successfully executed several substantial capital raising transactions and significantly expanded our R&D pipeline. I look forward to her future contributions and working with her as a strategic advisor,” said Lonnie Moulder, Chief Executive Officer of Zenas BioPharma. Second quarter 2026 financial results As of June 30, 2026, the Company’s cash, cash equivalents and investments were $673.9 million including $43.2 million aggregate net proceeds in April 2026 from the underwriters’ exercise in full of their over-allotment option for the convertible notes and option to purchase additional shares of common stock from the March 2026 concurrent public offerings. The Company expects that its cash, cash equivalents and investments, as of June 30, 2026, together with the net proceeds of $48.7 million received to date in the third quarter of 2026 from sales under its ATM facility, and assuming receipt of the potential $75 million milestone from Royalty Pharma and $75 million drawn from the debt facility with Pharmakon associated with achieving FDA marketing approval of obexelimab for IgG4-RD, its cash, cash equivalents and investments will fund its operating expenses and capital expenditure requirements at least through the second quarter of 2029. Revenue was $1.0 million for the quarter ended June 30, 2026, related to the achievement of a development milestone pursuant to the Company’s agreement with Tenacia Biotechnology (Hong Kong) Co., Limited associated with ZB005, which were originally licensed from Dianthus Therapeutics. The Company did not recognize revenue for the quarter ended June 30, 2025. Research and development (R&D) expenses were $62.9 million for the quarter ended June 30, 2026, compared to $43.0 million for the quarter ended June 30, 2025. The increase of $19.9 million in R&D expenses was primarily due to an increase in costs related to clinical trial and regulatory costs and an increase in personnel costs including stock-based compensation expense primarily due to an increase in headcount. General and administrative (G&A) expenses were $15.7 million for the quarter ended June 30, 2026, compared to $12.1 million for the quarter ended June 30, 2025. The increase of $3.6 million in G&A expenses was primarily due to an increase in personnel costs, including stock-based compensation expense primarily due to an increase in headcount associated with pre-commercialization activities and other expenses primarily attributable to company growth and continued operations as a public company. Acquired in-process research and development (AIPR&D) expenses were $30.0 million for the quarter ended June 30, 2026, which related to the achievement of a milestone under the Xencor Agreement for the completion of the FDA marketing authorization submission, and for the achievement of one of the near-term regulatory milestones under the InnoCare Agreement. The Company did not recognize AIPR&D expense for the quarter ended June 30, 2025. Other income (expense), net was $3.7 million of expense for the quarter ended June 30, 2026, compared to $3.0 million of income for the quarter ended June 30, 2025. The change of $6.6 million is primarily related to an increase in interest expense related to our royalty obligation, senior secured term loan and convertible senior notes, partially offset by interest income related to higher cash, cash equivalents and investments balances. Net loss was $111.5 million for the quarter ended June 30, 2026, compared to a net loss of $52.2 million for the quarter ended June 30, 2025. About Obexelimab Obexelimab is a bifunctional monoclonal antibody designed to bind both CD19 and FcγRIIb, which are broadly present across B cell lineage, to inhibit the activity of cells that are implicated in many autoimmune diseases without depleting them. This unique inhibitory mechanism of action and self-administered, subcutaneous injection regimen may broadly and effectively address the pathogenic role of the B cell lineage in chronic autoimmune disease. Obexelimab has been evaluated in eight clinical trials in a total of 383 subjects, including INDIGO. Obexelimab was well tolerated and demonstrated clinical activity across these clinical trials. Zenas expects to report topline results from a Phase 2 trial for obexelimab in systemic lupus erythematosus in the fourth quarter of 2026. About ZB021 ZB021 is a novel potentially best-in-class oral small molecule IL-17AA/AF inhibitor being developed by Zenas BioPharma in partnership with InnoCare Pharma. ZB021 is designed to selectively block the signal transduction pathways of both the IL-17AA homodimer and IL-17AF heterodimer, inhibiting downstream pro-inflammatory cytokine and chemokine release. Preclinical studies have demonstrated potent anti-inflammatory activity, a favorable safety profile, and excellent Absorption, Distribution, Metabolism, and Excretion (ADME) properties. The IL-17 pathway has demonstrated broad utility across many rheumatic and dermatologic indications. Currently, no oral IL-17 inhibitors have been approved or are in late-stage development globally. ZB021's oral, small molecule pro offer meaningful advantages over currently approved biologic IL-17 therapies in terms of convenience, compliance, and accessibility. Zenas licensed the exclusive rights from InnoCare Pharma to develop, manufacture, and commercialize ZB021 in all fields of use worldwide, excluding greater China and Southeast Asia. About Orelabrutinib Orelabrutinib is a late-stage, potentially best-in-class, highly selective central nervous system (CNS)-penetrant, oral, small molecule Bruton’s Tyrosine Kinase (BTK) inhibitor. Orelabrutinib’s mechanism of action targets pathogenic B cells in both the periphery and the CNS. Additionally, it directly modulates macrophages and microglial cells in the CNS, with the potential to address compartmentalized inflammation and disease progression in multiple sclerosis (MS). In MS, Zenas is advancing PriMroSe, a Phase 3 trial in Primary Progressive MS (PPMS), and Monarch, a Phase 3 trial in non-active Secondary Progressive MS (naSPMS). Orelabrutinib is approved for B cell malignancies in mainland China and Singapore, marketed by our partner InnoCare. About Zenas BioPharma Zenas is a clinical-stage global biopharmaceutical company focused on the development and commercialization of therapies for autoimmune diseases and inflammatory conditions. Zenas combines our experienced leadership team with a disciplined global product candidate acquisition approach to identify, acquire and develop product candidates with the potential to deliver clinically meaningful benefits to patients. Zenas is advancing two late-stage, potential franchise molecules, obexelimab and orelabrutinib. Obexelimab, Zenas’ lead product candidate, is a bifunctional monoclonal antibody designed to bind CD19 and FcγRIIb to inhibit the activity of B cells implicated in many autoimmune diseases without depleting them. Zenas believes that the unique mechanism of action of obexelimab and its self-administered, subcutaneous injection regimen may enable sustained control across multiple chronic autoimmune diseases. Orelabrutinib is a potentially best-in-class, highly selective CNS-penetrant, oral, small molecule BTK inhibitor. Orelabrutinib’s mechanism of action targets pathogenic B cells not only in the periphery but also within the CNS. Additionally, it directly modulates macrophages and microglial cells in the CNS, with the potential to address compartmentalized inflammation and disease progression in MS. Zenas’ earlier stage programs include ZB021, a novel, potentially best-in-class, oral, IL-17AA/AF inhibitor, ZB022, a preclinical, potentially best-in-class, oral, brain-penetrant, TYK2 inhibitor, and ZB014, a preclinical, half-life extended anti-CD19 and FcγRIIb monoclonal antibody. For more information about Zenas BioPharma, please visit and follow us on LinkedIn . Zenas BioPharma Forward-Looking Statements This press release contains “forward-looking statements” which involve risks, uncertainties and contingencies, many of which are beyond the control of the Company, which may cause actual results, performance, or achievements to differ materially from anticipated results, performance, or achievements. All statements other than statements of historical facts contained in this press release are forward-looking statements. In some cases, forward-looking statements can be identified by terms such as “may,” “will,” “should,” “expect,” “plan,” “anticipate,” “could,” “intend,” “target,” “project,” “contemplate,” “believe,” “estimate,” “predict,” “potential” or “continue” or the negative of these terms or other similar expressions, although not all forward-looking statements contain these words. Forward looking statements include, but are not limited to, statements regarding the Company’s product candidates, including the timing, progress and results of preclinical studies and clinical trials, including the timing of reporting the topline results from the SunStone trial and the ZB021 SAD and MAD study; the timing of regulatory submissions, including timing of our submission of a MAA to the EMA for obexelimab in IgG4-RD; subject to ZB021 SAD and MAD study results, the initiation of a POC trial of ZB021; the potential for ZB021 to provide meaningful advantages over currently approved biologics; subject to IND studies and clearance, the initiation of Phase 1 clinical studies of ZB014 and ZB022; the potential for ZB014 to provide the clinical activity and safety pro with obexelimab while offering a once-monthly dosing schedule; our ability to draw down on the Pharmakon debt facility; receipt of additional funding under our Royalty Pharma and Pharmakon agreements contingent upon FDA approval of obexelimab; the potential approval and commercialization of obexelimab; our readiness for commercialization; and the Company’s cash guidance. The forward-looking statements in this press release speak only as of the date of this press release and are subject to a number of known and unknown risks, uncertainties and assumptions that could cause the Company’s actual results to differ materially from those anticipated in the forward-looking statements, including, but not limited to: the Company’s limited operating history, incurrence of substantial losses since the Company’s inception and anticipation of incurring substantial and increasing losses for the foreseeable future; the Company’s need for substantial additional financing to achieve the Company’s goals; the uncertainty of clinical development, which is lengthy and expensive, and characterized by uncertain outcomes, and risks related to additional costs or delays in completing, or failing to complete, the development and commercialization of the Company’s current product candidates or any future product candidates; delays or difficulties in the enrollment and dosing of patients in clinical trials; the impact of any significant adverse events or undesirable side effects caused by the Company’s product candidates; potential competition, including from large and specialty pharmaceutical and biotechnology companies, many of which already have approved therapies in the Company’s current indications; the Company’s ability to realize the benefits of the Company’s current or future collaborations or licensing arrangements and ability to successfully consummate future partnerships; the Company’s ability to obtain regulatory approval to commercialize any product candidate in the United States or any other jurisdiction; the risk that the data from our clinical trials is not sufficient to the satisfaction of the FDA or comparable foreign regulatory authorities to support the submission of a biologics license application or other comparable submission or to obtain regulatory approval for our product candidates for which we seek approval in the U.S. or elsewhere, and the risk that any such approval may be for a more narrow indication than the Company seeks; the Company’s dependence on the services of the Company’s senior management and other clinical and scientific personnel, and the Company’s ability to retain these individuals or recruit additional management or clinical and scientific personnel; the Company’s ability to grow the Company’s organization, and manage the Company’s growth and expansion of the Company’s operations; risks related to the manufacturing of the Company’s product candidates, which is complex, and the risk that the Company’s third-party manufacturers may encounter difficulties in production; the Company’s ability to obtain and maintain sufficient intellectual property protection for the Company’s product candidates or any future product candidates the Company may develop; the Company’s reliance on third parties to conduct the Company’s preclinical studies and clinical trials; the Company’s compliance with the Company’s obligations under the licenses granted to the Company by others, for the rights to develop and commercialize the Company’s product candidates; significant political, trade, and regulatory developments, including changes in relations between the U.S. and China; risks related to the operations of the Company’s suppliers, many of which are located outside of the United States, including the Company’s current sole contract manufacturing organization for obexelimab drug substance and drug product, WuXi Biologics (Hong Kong) Limited, and our partner, InnoCare, both of which are located in China; the risk that the Company’s indebtedness resulting from the Company’s loan agreement with Pharmakon Advisors LP, and the guarantors party to such agreement, or future indebtedness could adversely affect the Company’s financial condition or restrict the Company’s future operations; and other risks and uncertainties described in the section “Risk Factors” in the Company’s Annual Report on Form 10-K for the year ended December 31, 2025, and Quarterly Report on Form 10-Q for the quarter ended June 30, 2026, as well as other information we the Securities and Exchange Commission. The forward-looking statements in this press release are inherently uncertain, speak only as of the date of this press release and may prove incorrect. These statements are based upon information available to the Company as of the date of this press release and while the Company believes such information forms a reasonable basis for such statements, such information may be limited or incomplete, and our statements should not be read to indicate that the Company has conducted an exhaustive inquiry into, or review of, all potentially available relevant information. Because forward-looking statements are inherently subject to risks and uncertainties, some of which cannot be predicted or quantified and some of which are beyond the Company’s control, these forward-looking statements should not be relied upon as guarantees of future events. The events and circumstances reflected in the forward-looking statements may not be achieved or occur and actual future results, levels of activity, performance and events and circumstances could differ materially from those projected in the forward-looking statements. Moreover, the Company operates in an evolving environment. New risks and uncertainties may emerge from time to time, and management cannot predict all risks and uncertainties. Except as required by applicable law, the Company does not undertake to publicly update or revise any forward-looking statements contained herein, whether as a result of any new information, future events, changed circumstances or otherwise. The Zenas BioPharma word mark, logo mark, and the “lightning bolt” design are trademarks of Zenas BioPharma, Inc. or its affiliated companies. All rights reserved. Contacts: Investors: Argot Partners Zenas@argotpartners.com Media: Kristin Ainsworth SVP, U.S. Commercial Strategy & Corporate Affairs 612.839.6748 Zenas BioPharma, Inc. CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS (Unaudited) (in thousands except share and per share amounts) Three Months Ended June 30, 2026 2025 Revenue: License and collaboration revenue $ 1,000 $ — Total revenue 1,000 — Operating expenses: Research and development 62,913 43,027 General and administrative 15,746 12,136 Acquired in-process research and development 30,000 — Total operating expenses 108,659 55,163 Loss from operations (107,659 ) (55,163 ) Other income (expense), net (3,683 ) 2,960 Income tax provision 114 20 Net loss $ (111,456 ) $ (52,223 ) Net loss per share - basic and diluted $ (1.77 ) $ (1.25 ) Weighted-average common stock outstanding - basic and diluted 63,112,314 41,865,400 Zenas BioPharma, Inc. SELECTED CONSOLIDATED BALANCE SHEET DATA (Unaudited) (in thousands) June 30, December 31, 2026 2025 Cash, cash equivalents and investments $ 673,889 $ 360,464 Total assets 701,690 383,640 Royalty obligation 91,737 78,636 Senior secured term loan, net 74,060 — Convertible senior notes, net 222,956 — Total liabilities 454,593 141,496 Working capital 587,976 288,522 Accumulated deficit (957,571 ) (765,128 ) Total stockholders’ equity 247,097 242,144

Advancing a neuromuscular franchise with claseprubart, a highly potent investigational classical pathway inhibitor, with best-in-disease potential across generalized Myasthenia Gravis (gMG), Chronic Inflammatory Demyelinating Polyneuropathy (CIDP), and Multifocal Motor Neuropathy (MMN) Phase 3 EMERGE registrational trial of claseprubart in gMG evaluating 300mg/2mL Q2W and 300mg/2mL Q4W initiated in June ‘26, with top-line results anticipated in 2H’28 75% response rate observed in Interim Responder Analysis from first 40 participants completing Part A of Phase 3 CAPTIVATE trial of claseprubart in CIDP, with Part B top-line guidance expected by YE’26 Phase 2 MoMeNtum trial of claseprubart in MMN exceeded its original enrollment target of 36 patients; top-line results with 46 patients on track for December ’26 ezstandalone.cmd.push(function () { ezstandalone.showAds(131); }); Building a rheumatology franchise with DNTH212 across our first three prioritized indications of Sjögren’s Disease (SjD), Systemic Lupus Erythematosus (SLE), and Dermatomyositis (DM); Phase 1 healthy volunteer data anticipated by YE’26 Advancing DNTH312, an internally developed, first-in-class, next-generation bifunctional fusion protein combining claseprubart and TACI to target potent inhibition of aC1s and BAFF/APRIL for severe autoimmune diseases; DNTH312 aims to be Phase 1 ready by YE’27 Approximately $1.2 billion of cash as of June 30, 2026 provides expected runway into 2030 NEW YORK and WALTHAM, Mass., Aug. 04, 2026 (GLOBE NEWSWIRE) -- Dianthus Therapeutics, Inc. (Nasdaq: DNTH), a clinical-stage biotechnology company dedicated to developing next-generation therapies to transform the treatment of severe autoimmune diseases, today reported financial results for the second quarter ending June 30, 2026, and provided an update on other recent business achievements. “Our strong execution in the first half of 2026 reflects the continued focus and discipline of the Dianthus team as we advance both claseprubart and DNTH212 for severe autoimmune diseases,” said Marino Garcia, Chief Executive Officer of Dianthus Therapeutics. “With the initiation of our Phase 3 EMERGE registrational trial in gMG, excellent interim results from Part A of our Phase 3 CAPTIVATE trial in CIDP, and completion of enrollment in the Phase 2 MoMeNtum trial in MMN with top-line results expected in December, claseprubart continues to demonstrate its potential as a best-in-disease, pipeline-in-a-product opportunity. In addition, we anticipate Phase 1 healthy volunteer data for DNTH212 by year end. We continue to strengthen our leadership position in autoimmune diseases with today’s announcement of the addition of our innovative, internally developed, first-in-class, next generation, highly potent and half-life extended bifunctional fusion protein, DNTH312.” Claseprubart: Potential Best-in-Disease aC1s Inhibitor for Neuromuscular Diseases Claseprubart is an investigational, clinical-stage, potent monoclonal antibody engineered to selectively target the classical pathway by inhibiting only the active form of the C1s protein, a clinically validated complement target. Claseprubart is designed to enable a more convenient, subcutaneous (S.C.), self-administered injection dosed as infrequently as once every two or four weeks. Claseprubart has the potential to be a best-in-disease pipeline-in-a-product across a range of autoimmune disorders with high unmet need. Generalized Myasthenia Gravis (gMG) Phase 3 EMERGE trial initiated, with top-line results expected in 2H’28: A Phase 3 registrational trial of claseprubart evaluating 300mg/2mL Q2W S.C. and 300mg/2mL Q4W S.C. in gMG patients was initiated in June, with top-line results expected in 2H’28. Chronic Inflammatory Demyelinating Polyneuropathy (CIDP) 75% response rate observed in Interim Responder Analysis from first 40 participants completing Part A of Phase 3 CAPTIVATE trial , exceeding the target response rate of 50% or greater based on precedent set with aC1s inhibition. Results were consistent and clinically meaningful across multiple efficacy measures. Claseprubart was generally well tolerated with no related serious infections, no clinical symptoms of drug-induced lupus (DIL), no related serious adverse events (SAEs) or discontinuations due to safety. Dianthus expects to provide CAPTIVATE Part B top-line guidance by YE’26. Multifocal Motor Neuropathy (MMN) Enrollment completed, exceeding the enrollment target, in the Phase 2 MoMeNtum trial , with top-line results on track for December ‘26: The MoMeNtum trial, a global, randomized, double-blind, placebo-controlled Phase 2 trial in patients with MMN, exceeded its original enrollment target of 36 patients. Top-line results with 46 patients are on track for December ’26. All Programs Claseprubart presentations at the American Academy of Neurology (AAN), Peripheral Nerve Society (PNS), and European Academy of Neurology (EAN) meetings described the design of the pivotal Phase 3 CAPTIVATE study in CIDP, Phase 2 MaGic trial results in gMG, Minimal Symptom Expression (MSE) results for claseprubart from MaGic, and potential mechanistic advantages of targeting aC1s in gMG. Presentations are available in the Investors section of the Dianthus website . In March 2026, the Company filed an 8K indicating receipt of written feedback from FDA agreeing to three proposals for all ongoing and planned future claseprubart trials: Removal of anti-nuclear antibodies ("ANAs") as a screening criteria, a common reason for screen failure across all three claseprubart programs; Removal of routine ANA testing during claseprubart clinical trials; and Reclassification of the hypothetical risk of SLE to drug-induced lupus (DIL), a side effect in several classes of widely used medications characterized by the reversal of symptoms upon discontinuation of the precipitating medication. Of note, there have been no cases of either SLE or DIL to date in any claseprubart program. DNTH212: Potential Best-in-Disease, Bifunctional BDCA2 and BAFF/APRIL Inhibitor for Rheumatology Conditions DNTH212 is an investigational, extended half-life bifunctional fusion protein targeting plasmacytoid dendritic cell (pDC) BDCA2 to reduce Type 1 interferon production, while simultaneously inhibiting BAFF/APRIL to suppress B cell function. By targeting both the innate and adaptive immune systems via two clinically validated pathways that are known drivers of autoimmune disease pathogenesis, this complementary and differentiated approach has the potential to address multiple autoimmune indications with improved outcomes. Phase 1 data anticipated by year end: A two-part Phase 1 study in China in healthy volunteers (Part A) and patients with systemic lupus erythematosus (Part B) was initiated in December 2025, with Phase 1 healthy volunteer data anticipated by year end. Upon completion of the Phase 1 study, Dianthus plans to provide an update on next steps for advancing its priority indications in clinical development. Initial indications selected for DNTH212 clinical development: SjD, SLE, and DM were selected as the first three priority indications for DNTH212 clinical development and will serve as the foundation of a synergistic rheumatology franchise for DNTH212. DNTH312: An Internally Developed, First-in-class, Next-generation Bifunctional Fusion Protein Combining Claseprubart and TACI to Target Potent Inhibition of aC1s and BAFF/APRIL for Autoimmune Diseases DNTH312 is an internally developed, investigational, first-in-class, next-generation bifunctional fusion protein combining claseprubart and TACI to target potent inhibition of aC1s and BAFF/APRIL. By targeting two validated pathways with complementary disease modifying mechanisms, DNTH312 expands Dianthus’ leadership position in autoimmune diseases with its potential for best-in-disease efficacy by targeting deeper responses and broader symptom control, while also addressing larger patient populations. DNTH312 demonstrated comparable in vitro potency and aC1s inhibition to claseprubart across several functional assays of Classical Pathway inhibition and a similar depth of IgM, IgA, and IgG reductions vs. published values for povetacicept following a single dose in non-human primates (NHPs). Additionally, DNTH312 is enhanced with YTE half-life extension technology, and has a similar NHP half-life (22 days) to claseprubart, which has an approximately 60-day half-life in humans. DNTH312 aims to be Phase 1 ready by YE’27. Second-Quarter 2026 Financial Results Cash Position – Approximately $1.2 billion of cash, cash equivalents and investments as of June 30, 2026 is projected to provide runway into 2030. R&D Expenses – Research and development (R&D) expenses for the quarter ended June 30, 2026 were $48.7 million, inclusive of $5.6 million of stock-based compensation, compared to $26.3 million for the quarter ended June 30, 2025, which included $2.5 million of stock-based compensation. This increase in R&D expenses was primarily driven by higher clinical costs and increased headcount to support claseprubart Phase 2 and Phase 3 development. G&A Expenses – General and administrative (G&A) expenses for the quarter ended June 30, 2026 totaled $13.6 million, inclusive of stock-based compensation of $6.3 million, compared to $8.9 million for the quarter ended June 30, 2025, which included $3.2 million of stock-based compensation. This increase in G&A expenses was primarily due to increased headcount. Net Loss – Net loss for the quarter ended June 30, 2026 was $50.2 million or $0.90 per share (basic and diluted) compared to $31.6 million or $0.88 per share (basic and diluted) for the quarter ended June 30, 2025. Additional Information – For additional information on the Company’s financial results for the quarter ended June 30, 2026, please refer to the Form 10-Q filed with the SEC. About Claseprubart (DNTH103) Claseprubart is an investigational, clinical-stage, potent monoclonal antibody engineered to selectively target the classical pathway by inhibiting only the active form of the C1s protein, a clinically validated complement target. Claseprubart is enhanced with YTE half-life extension technology designed to enable a more convenient subcutaneous, infrequently dosed, self-administered injection. Additionally, selective inhibition of the classical complement pathway may lower patient risk of infection from encapsulated bacteria by preserving immune activity of the lectin and alternative pathways. As the classical pathway plays a significant role in disease pathology, claseprubart has the potential to be a best-in-disease pipeline-in-a-product across a range of autoimmune disorders with high unmet need. Claseprubart was granted Orphan Drug Designation by the FDA for the treatment of Myasthenia Gravis in May 2026. Dianthus is building a neuromuscular franchise with claseprubart and expects to report top-line data from the Phase 2 MoMeNtum trial in Multifocal Motor Neuropathy in December ’26, to provide an update on timing of top-line data from Part B of the Phase 3 CAPTIVATE trial in Chronic Inflammatory Demyelinating Polyneuropathy by YE’26, and to report top-line results from the Phase 3 EMERGE trial in generalized Myasthenia Gravis in 2H’28. Claseprubart is an investigational agent that is not approved as a therapy in any indication in any jurisdiction worldwide. About DNTH212 DNTH212 is an investigational, extended half-life bifunctional fusion protein targeting plasmacytoid dendritic cell (pDC) BDCA2 to reduce Type 1 interferon production, while simultaneously inhibiting BAFF/APRIL to suppress B cell function. By targeting both the innate and adaptive immune systems via two clinically validated pathways that are known drivers of autoimmune disease pathogenesis, this complementary and differentiated approach has the potential to address multiple autoimmune indications with improved outcomes. Dianthus is building a rheumatology franchise with DNTH212 and has selected Sjögren’s Disease (SjD), Systemic Lupus Erythematosus (SLE), and Dermatomyositis (DM) as the first three prioritized indications for clinical development. A two-part Phase 1 study in China in healthy volunteers (Part A) and patients with systemic lupus erythematosus (Part B) is ongoing, with healthy volunteer data expected by YE’26. DNTH212 is an investigational agent that is not approved as a therapy in any indication in any jurisdiction worldwide. About DNTH312 DNTH312 is an internally developed, investigational, first-in-class, next-generation bifunctional fusion protein combining claseprubart and TACI to target potent inhibition of aC1s and BAFF/APRIL. DNTH312 is enhanced with YTE half-life extension technology, similar to claseprubart. By targeting two validated pathways with complementary disease modifying mechanisms, DNTH312 is designed to expand Dianthus’ leadership position in autoimmune diseases with potential for best-in-disease efficacy by targeting deeper responses and broader symptom control, while also addressing larger patient populations. DNTH312 aims to be Phase 1 ready by YE’27. DNTH312 is an investigational agent that is not approved as a therapy in any indication in any jurisdiction worldwide. About Dianthus Therapeutics Dianthus Therapeutics, Inc. is a clinical-stage biotechnology company dedicated to developing next-generation therapies to transform the treatment of severe autoimmune diseases. Based in New York City and Waltham, Mass., Dianthus is comprised of an experienced team of biotech and pharma executives who aim to deliver transformative medicines for people living with severe autoimmune and inflammatory diseases. To learn more, please visit and follow us on LinkedIn . Cautionary Statement Regarding Forward-Looking Statements Certain statements in this press release, other than purely historical information, may constitute “forward-looking statements” within the meaning of the federal securities laws, including for purposes of the safe harbor provisions under the United States Private Securities Litigation Reform Act of 1995, express or implied statements regarding future plans and prospects, including statements regarding the expectations or plans for discovery, preclinical studies, clinical trials and research and development programs, in particular with respect to claseprubart, DNTH212, and DNTH312, and any developments or results in connection therewith, including the target product pro administration of claseprubart, DNTH212, and DNTH312; the anticipated timing of the initiation and results from those studies and trials; expectations regarding the clinical trial designs or indications; expectations regarding the time period over which the Company’s capital resources are expected to be sufficient to fund its anticipated operations; and expectations regarding market size, patient population size, and potential market opportunities, in particular with respect to claseprubart, DNTH212 and DNTH312. Claseprubart, DNTH212, and DNTH312 are investigational agents that are not approved as therapies in any indication in any jurisdiction worldwide. The words “opportunity,” “potential,” “milestones,” “runway,” “will,” “anticipate,” “achieve,” “near-term,” “catalysts,” “pursue,” “pipeline,” “believe,” “continue,” “could,” “estimate,” “expect,” “intend,” “may,” “might,” “plan,” “possible,” “predict,” “project,” “should,” “strive,” “would,” “aim,” “target,” “commit,” and similar expressions (including the negatives of these terms or variations of them) generally identify forward-looking statements, but the absence of these words does not mean that statement is not forward looking. Actual results could differ materially from those included in the forward-looking statements due to various factors, risks and uncertainties, including, but not limited to, that preclinical testing of claseprubart, DNTH212, and DNTH312 and data from clinical trials may not be predictive of the results or success of ongoing or later clinical trials, that the preliminary interim analysis based on a limited number of patients from the Part A open label portion of the claseprubart CAPTIVATE study in patients with CIDP may not be predictive of the results or success of the remaining patients treated in Part A or patients treated in Part B of the CAPTIVATE study, that the development of claseprubart, DNTH212, or DNTH312 may take longer and/or cost more than planned, that the Company or its partner may be unable to successfully complete the clinical development of the Company’s compounds, that the Company or its partner may be delayed in initiating, enrolling or completing its planned clinical trials, and that the Company's compounds may not receive regulatory approval or become commercially successful products. These and other risks and uncertainties are identified under the heading "Risk Factors" included in the Company’s Annual Report on Form 10-K for the period ended December 31, 2025, and other filings that the Company has made and may make with the SEC in the future. Nothing in this press release should be regarded as a representation by any person that the forward-looking statements set forth herein will be achieved or that any of the contemplated results of such forward-looking statements will be achieved. The forward-looking statements in this press release speak only as of the date they are made and are qualified in their entirety by reference to the cautionary statements herein. Dianthus undertakes no obligation to publicly update or revise any forward-looking statement, whether as a result of new information, future events or otherwise, except as required by law. Contact Jennifer Davis Ruff Dianthus Therapeutics jdavisruff@dianthustx.com DIANTHUS THERAPEUTICS, INC. Condensed Consolidated Balance Sheets (in thousands, except share and per share data) (unaudited) June 30, 2026 December 31, 2025 Assets Current assets: Cash and cash equivalents $ 110,549 $ 51,087 Short-term investments 776,264 353,208 Accounts receivable, net 106 52 Prepaid expenses and other current assets 10,618 5,091 Total current assets 897,537 409,438 Long-term investments 303,633 110,135 Property and equipment, net 418 296 Right-of-use operating lease assets 1,223 1,337 Other assets and restricted cash 10,460 9,716 Total assets $ 1,213,271 $ 530,922 Liabilities and Stockholders’ Equity Current liabilities: Accounts payable $ 6,390 $ 9,725 Accrued expenses 26,101 19,452 Current portion of deferred revenue 1,524 1,188 Current portion of operating lease liabilities 374 367 Total current liabilities 34,389 30,732 Deferred revenue 5,944 5,770 Long-term operating lease liabilities 913 1,019 Total liabilities 41,246 37,521 Commitments and contingencies Stockholders’ equity: Preferred stock — — Common stock 55 43 Additional paid-in capital 1,601,876 829,598 Accumulated deficit (427,778 ) (336,729 ) Accumulated other comprehensive (loss)/income (2,128 ) 489 Total stockholders’ equity 1,172,025 493,401 Total liabilities and stockholders’ equity $ 1,213,271 $ 530,922 DIANTHUS THERAPEUTICS, INC. Condensed Consolidated Statements of Operations and Comprehensive Loss (in thousands, except share and per share data) (unaudited) Three Months Ended June 30, Six Months Ended June 30, 2026 2025 2026 2025 Revenues: License revenue $ 761 $ 193 $ 1,224 $ 1,356 Operating expenses: Research and development 48,686 26,251 83,214 53,254 General and administrative 13,557 8,869 26,025 16,206 Total operating expenses 62,243 35,120 109,239 69,460 Loss from operations (61,482 ) (34,927 ) (108,015 ) (68,104 ) Other income/(expense): Interest and investment income 11,542 3,403 17,807 7,194 Gain/(loss) on investment in former related party 105 32 (197 ) 27 Loss on currency exchange, net (10 ) (30 ) (25 ) (52 ) Other expense (370 ) (107 ) (619 ) (205 ) Total other income 11,267 3,298 16,966 6,964 Net loss $ (50,215 ) $ (31,629 ) $ (91,049 ) $ (61,140 ) Net loss per share attributable to common stockholders, basic and diluted $ (0.90 ) $ (0.88 ) $ (1.75 ) $ (1.71 ) Weighted-average number of shares of common stock outstanding including shares issuable under equity-classified pre-funded warrants, used in computing net loss per share of common stock, basic and diluted 56,029,124 35,822,308 52,053,022 35,806,591 Comprehensive loss: Net loss $ (50,215 ) $ (31,629 ) $ (91,049 ) $ (61,140 ) Other comprehensive loss: Unrealized loss on marketable securities (1,553 ) (172 ) (2,617 ) (8 ) Total other comprehensive loss (1,553 ) (172 ) (2,617 ) (8 ) Total comprehensive loss $ (51,768 ) $ (31,801 ) $ (93,666 ) $ (61,148 )