Multiple Late-Stage Data Readouts Reinforce Telitacicept’s Broad Potential Across Autoimmune DiseasesExpansion of Executive Leadership and Board Strengthens Global Development Capabilities Expected gross proceeds of $115 million raised in the November 2025 underwritten public offering, including the underwriters’ full exercise of the option to purchase additional shares BOSTON, Nov. 13, 2025 (GLOBE NEWSWIRE) -- Vor Bio (Nasdaq: VOR), a clinical-stage biotechnology company transforming the treatment of autoi ...

Core Insights - Zenas BioPharma reported significant advancements in its clinical trials, particularly with obexelimab, which showed promising results in treating autoimmune diseases [1][2][3] - The company has secured substantial funding to support its clinical development and commercialization efforts, including a $300 million agreement with Royalty Pharma [1][6] - Zenas is expanding its product pipeline with the acquisition of three new autoimmune product candidates, including orelabrutinib, which is in Phase 3 development for multiple sclerosis [1][3][10] Clinical Trial Updates - The Phase 3 INDIGO trial for obexelimab in Immunoglobulin G4-Related Disease (IgG4-RD) is set to report topline results around year-end 2025, marking it as the largest clinical trial for this condition to date [1][3] - The Phase 2 MoonStone trial for obexelimab in Relapsing Multiple Sclerosis (RMS) demonstrated a 95% relative reduction in new gadolinium-enhancing lesions compared to placebo, with a p-value of 0.0009 [3][4] - Zenas expects to report 24-week data from the MoonStone trial in the first quarter of 2026 [3] Financial Highlights - As of September 30, 2025, Zenas had cash, cash equivalents, and investments totaling $301.6 million, which, along with recent financing, is expected to fund operations into the fourth quarter of 2026 [7][18] - The company reported a net loss of $51.5 million for the third quarter of 2025, compared to a net loss of $38.6 million for the same period in 2024 [13][17] - Research and development expenses for the quarter were $34.4 million, while general and administrative expenses increased to $13.2 million from $7.5 million year-over-year [7][17] Pipeline Expansion - Zenas has entered into a license agreement for orelabrutinib, a BTK inhibitor, granting global development and commercialization rights outside Greater China and Southeast Asia [3][10] - The company is also advancing two additional product candidates, ZB021 and ZB022, both of which are expected to enter Phase 1 clinical development in 2026 [4][10] Company Overview - Zenas BioPharma is focused on developing transformative therapies for autoimmune diseases, with a strategy that includes acquiring and developing product candidates that offer superior clinical benefits [11] - The company aims to become a leader in the biopharmaceutical industry, leveraging its experienced leadership and disciplined approach to product development [11]

Core Insights - Nkarta, Inc. has reported significant progress in its NKX019 clinical program aimed at treating autoimmune diseases, marking a key milestone in its development efforts [2][4] - The company has streamlined patient enrollment in its Ntrust-1 and Ntrust-2 clinical trials, enhancing efficiency and safety profile consistency for NKX019 [2][6][7] - Financially, Nkarta maintains a strong cash position of $316.5 million as of September 30, 2025, which is projected to fund operations into 2029 [6][9] Clinical Program Developments - Enrollment is currently underway in the second dose-escalation cohort, with complete B-cell depletion observed in all patients treated with NKX019 using a modified lymphodepletion regimen [6][3] - The FDA has approved protocol amendments that allow for simultaneous dosing of multiple participants, expediting the trial process [7][3] - Initial data from the NKX019 trials in multiple autoimmune indications is expected to be presented at a medical conference in 2026 [6][10] Financial Highlights - For the third quarter of 2025, Nkarta reported a net loss of $21.7 million, or $0.29 per share, which includes non-cash charges primarily related to share-based compensation [8][21] - Research and development expenses for the third quarter were $20.2 million, while general and administrative expenses were $7.1 million [7][21] - The total operating expenses for the third quarter amounted to $27.3 million, compared to $33.8 million in the same quarter of the previous year [21] Balance Sheet Overview - As of September 30, 2025, Nkarta's total assets were valued at $427.2 million, with liabilities amounting to $89.3 million [23] - The company's cash, cash equivalents, restricted cash, and investments decreased from $380.5 million at the end of 2024 to $316.5 million [23]

Core Insights - Takeda has presented new data indicating that mezagitamab (TAK-079) shows sustained effects on kidney function in patients with primary IgA nephropathy, maintaining stable kidney function (eGFR) 18 months after the last treatment dose [1][2][4] Group 1: Clinical Study Results - In a Phase 1b open-label study, kidney function remained stable in patients with IgA nephropathy through Week 96, with a mean change in eGFR from baseline of +2.5 (95% CI: 1.8, +7.6; n=12) [4] - Patients experienced a 55.2% mean reduction in proteinuria (95% CI: 30.2, 72.6; n=13) and a 50.1% reduction in Gd-IgA1 levels by Week 96 [4][5] - Hematuria resolved in 60% of patients by Week 96, indicating significant improvements in kidney health [4] Group 2: Safety and Tolerability - Mezagitamab was generally well tolerated, with no serious adverse events, including serious hypersensitivity or injection-related reactions reported [5][6] - The study did not identify any new safety concerns, reinforcing the potential of mezagitamab as a treatment for autoimmune diseases like IgA nephropathy [5] Group 3: Future Development and Designations - Takeda is currently conducting pivotal Phase 3 clinical trials for mezagitamab in both primary IgA nephropathy and chronic immune thrombocytopenia, with patient enrollment ongoing [6] - Mezagitamab received Orphan Drug Designation from the European Medicines Agency for primary IgA nephropathy and Breakthrough Therapy Designation from the U.S. FDA for chronic immune thrombocytopenia [6]

Enrollment on track in Phase 3 AURORA trial of Descartes-08 in myasthenia gravis Preliminary data from Phase 2 trial of Descartes-08 in systemic lupus erythematosus expected by end of year Initiation of Phase 2 pediatric basket trial of Descartes-08 in select autoimmune indications expected by end of year Approximately $145.1 million cash, cash equivalents and restricted cash as of September 30, 2025, expected to support planned operations into mid-2027, including completion of ongoing Phase 3 AURORA tria ...

Core Insights - Dianthus Therapeutics reported significant advancements in the clinical development of claseprubart, particularly in the Phase 2 MaGic trial for generalized Myasthenia Gravis (gMG), showing statistically significant improvements in MG-ADL and QMG scores at Week 13 [1][4][5] - The company has accelerated the timeline for the interim responder analysis of the Phase 3 CAPTIVATE trial in Chronic Inflammatory Demyelinating Polyneuropathy (CIDP) to Q2 2026 due to faster enrollment [1][6] - An exclusive licensing agreement for DNTH212, a bifunctional BDCA2 and BAFF/APRIL inhibitor, was announced, with Phase 1 data expected in 2H 2026 [1][8][12] - Dianthus has an estimated cash position of approximately $525 million, providing financial runway into 2028 [1][18] Clinical Development Updates - Claseprubart demonstrated rapid and clinically meaningful improvements in gMG patients, with the 300mg/2mL Q2W dose showing significant efficacy across multiple endpoints [4][5] - The Phase 3 trial for claseprubart in gMG is anticipated to begin in 2026, with a focus on both 300mg/2mL Q2W and Q4W dosing [1][11] - The ongoing Phase 2 MoMeNtum trial for Multifocal Motor Neuropathy (MMN) is expected to yield top-line results in 2H 2026 [1][7] Financial Performance - For Q3 2025, Dianthus reported a net loss of $36.8 million, or $0.97 per share, compared to a net loss of $25.2 million, or $0.74 per share, in Q3 2024 [10][24] - Research and development expenses increased to $32.5 million in Q3 2025, driven by higher clinical costs and increased headcount [10][18] - General and administrative expenses rose to $8.2 million in Q3 2025, reflecting increased staffing [10][18] Corporate Strategy - The company aims to establish itself as a leader in the autoimmune disease treatment space, focusing on delivering best-in-class therapies with infrequent, subcutaneous self-administration [2][3] - The CEO emphasized the importance of executing their plans to advance both claseprubart and DNTH212 as transformative therapies for severe autoimmune diseases [2][3]

Core Insights - AlphaQuest LLC increased its stake in Forte Biosciences by 300.7% in Q2, owning 16,897 shares valued at $218,000 [2] - Analysts have mixed ratings on Forte Biosciences, with a consensus rating of "Moderate Buy" and an average price target of $68.00 [3] - Forte Biosciences reported an EPS of ($0.96) for the last quarter, exceeding the consensus estimate of ($1.21) by $0.25 [5] Company Overview - Forte Biosciences is a biopharmaceutical company based in Dallas, Texas, focusing on developing treatments for autoimmune diseases [6] - The company is working on the FB-102 program, targeting conditions such as graft-versus-host disease, vitiligo, and alopecia areata [6] Stock Performance - Forte Biosciences shares opened at $12.94, with a market capitalization of $160.84 million and a P/E ratio of -1.88 [4] - The stock has experienced a 12-month low of $4.11 and a high of $28.68 [4]

Core Insights - Vor Bio announced clinical data from Stage A of a Phase 3 study in China for telitacicept, targeting IgA nephropathy (IgAN), to be presented at ASN Kidney Week 2025 [1][2] - Telitacicept achieved a primary endpoint with a 55% reduction in 24-hour urine protein-to-creatinine ratio (UPCR) at 39 weeks compared to placebo, indicating significant efficacy [2] - RemeGen has submitted a Biologics License Application (BLA) for telitacicept in IgAN to the NMPA in China, which would mark its fifth approved indication in the country [3] Company Overview - Vor Bio is a clinical-stage biotechnology company focused on advancing telitacicept, a dual-target fusion protein, for treating autoimmune diseases [4] - Telitacicept selectively inhibits BLyS (BAFF) and APRIL, two cytokines essential for B cell survival, thereby reducing autoreactive B cells and autoantibody production [5] - The drug is already approved in China for systemic lupus erythematosus, rheumatoid arthritis, and generalized myasthenia gravis, with ongoing global Phase 3 trials for further approvals [6] Industry Context - IgA nephropathy is a leading cause of chronic kidney disease and end-stage renal disease, with up to 40% of patients progressing to ESRD within 20 years of diagnosis, highlighting the need for effective therapies [7] - Current treatments primarily slow disease progression without addressing the underlying immunopathology, indicating a significant unmet medical need [7] - The overproduction of galactose-deficient IgA1 is recognized as a central driver of IgAN, with BAFF and APRIL promoting its production [8]

Core Insights - Cabaletta Bio is advancing its investigational CAR-T cell therapy, rese-cel, with plans for a Biologics License Application (BLA) submission for myositis anticipated in 2027 following FDA alignment on registrational pathways [1][11] - The company has successfully enrolled five disease-specific cohorts in the RESET™ clinical development program, with ongoing expansion phase enrollment [1][4] - Recent clinical data presented at the EULAR 2025 Congress indicate strong therapeutic potential for rese-cel, with nearly all patients off immunomodulatory medications and steroids [1][4] Clinical Development - Rese-cel is designed to treat autoimmune diseases by transiently depleting CD19-positive cells, aiming for durable clinical responses without chronic therapy [3] - Enrollment in two open-label, single-arm registrational myositis cohorts is set to begin in the second half of 2025, each consisting of approximately 15 patients [4][11] - Upcoming presentations will include complete Phase 1/2 data from the RESET-Myositis trial and initial data from RESET-PV and RESET-MG trials [4] Regulatory - The FDA has aligned with Cabaletta on key design elements for registrational cohorts in the RESET-Myositis trial, which includes patients with dermatomyositis and antisynthetase syndrome [11] - Additional regulatory discussions are planned for the RESET-SLE and RESET-SSc trials in late 2025 and early 2026 [11] Financial Overview - Cabaletta closed a $100 million public offering to support late clinical-stage development and extended its cash runway into the second half of 2026 [1][7] - For Q2 2025, research and development expenses were $37.6 million, up from $23.4 million in Q2 2024, while general and administrative expenses rose to $8.3 million from $6.9 million [12][17] - As of June 30, 2025, the company reported cash, cash equivalents, and short-term investments of $194.7 million, an increase from $164.0 million at the end of 2024 [12][19]

FORTE BIOSCIENCES CLINICAL STAGE FB-102 3 FB102 CELIAC DISEASE PHASE 1B RESULTS JUNE 2025 1 CAUTIONARY NOTE REGARDING FORWARD-LOOKING STATEMENTS 2 Certain statements contained in this presentation regarding matters that are not historical facts, are forward-looking statements within the meaning of Section 21E of the Securities and Exchange Act of 1934, as amended, and the Private Securities Litigation Act of 1995, known as the PSLRA. These include statements regarding management's intention, plans, beliefs, ...