Aurinia Pharmaceuticals (NasdaqGM:AUPH) Q4 2025 Earnings call February 26, 2026 08:30 AM ET Company ParticipantsGreg Keenan - Chief Medical OfficerJoe Miller - CFOPeter Greenleaf - President and CEOSahil Dhingra - Senior Equity Research AssociateWill Sawicki - AssociateConference Call ParticipantsArthur He - AnalystDavid Martin - AnalystFarzin Haque - Senior Vice President and Biotechnology Equity Research AnalystOlivia Brayer - Senior Equity AnalystOperatorGood morning. Welcome to the Aurinia Pharmaceutica ...

Core Viewpoint - InnoCare Pharma has made significant progress in clinical development, completing patient enrollment in multiple Phase III registrational trials for its cancer and autoimmune disease treatments [1] Group 1: Clinical Development Progress - The company completed patient enrollment in a Phase III trial for the BCL2 inhibitor mesutoclax (ICP-248) combined with BTK inhibitor orelabrutinib for treatment-naïve chronic lymphocytic leukemia/small lymphocytic lymphoma (CLL/SLL) patients [2] - InnoCare has also accelerated the clinical development of two novel TYK2 inhibitors, completing patient enrollment in the Phase III trial of soficitinib (ICP-332) for moderate to severe atopic dermatitis and in the Phase III trial of ICP-488 for psoriasis [4] - Additionally, patient enrollment has been completed in a Phase II trial of soficitinib for vitiligo, targeting various T-cell related autoimmune disorders [5] Group 2: Drug Mechanisms and Indications - Mesutoclax is a selective oral BCL2 inhibitor that restores normal apoptosis in cancer cells, aiming to provide deeper remission for treatment-naïve CLL/SLL patients [3] - Soficitinib is a potent TYK2 inhibitor being developed for multiple dermatological conditions, including atopic dermatitis, vitiligo, prurigo nodularis, CSU, and psoriasis [5][6] - ICP-488, an oral allosteric TYK2 inhibitor, blocks inflammatory cytokine signaling pathways, addressing autoimmune and inflammatory diseases [6] Group 3: Company Overview - InnoCare is a commercial stage biopharmaceutical company focused on developing first-in-class and best-in-class drugs for cancer and autoimmune diseases with unmet medical needs [7]

Core Insights - Obexelimab demonstrated a 95% relative reduction in new gadolinium-enhancing T1 lesions compared to placebo in the Phase 2 MoonStone trial, indicating significant efficacy in treating Relapsing Multiple Sclerosis (RMS) [1][2] - The 24-week data further confirmed the drug's robust and durable activity, maintaining significant reductions in lesions and improving biomarkers associated with disease activity [3][4] - The safety profile of obexelimab was consistent with previous trials, showing good tolerability without new safety signals [2][3] Company Overview - Zenas BioPharma, Inc. is a clinical-stage global biopharmaceutical company focused on developing transformative therapies for autoimmune diseases [12] - The company is advancing two late-stage product candidates: obexelimab and orelabrutinib, with obexelimab being the lead candidate targeting B cell activity [12] - Zenas plans to submit a Biologics License Application (BLA) for obexelimab in the second quarter of 2026 and a Marketing Authorization Application (MAA) in the second half of 2026 for Immunoglobulin G4-Related Disease [11][12] Clinical Trial Details - The Phase 2 MoonStone trial enrolled 116 patients and was designed to evaluate the efficacy and safety of obexelimab in RMS, using MRI endpoints to measure treatment outcomes [9] - The trial's primary endpoint was the cumulative number of new gad-enhancing T1 lesions over weeks 8 and 12, with secondary endpoints assessing disease progression through various biomarkers [9] - Following the double-blind phase, patients transitioned to an open-label period to continue treatment and assess long-term outcomes [9] Mechanism of Action - Obexelimab is a bifunctional monoclonal antibody that binds to CD19 and FcγRIIb, inhibiting B cell activity without depleting them, which is crucial for addressing autoimmune diseases [10][12] - The drug's unique mechanism and self-administered subcutaneous injection regimen may effectively target the pathogenic role of B cells in chronic autoimmune conditions [10][12]

Core Insights - Zenas BioPharma, Inc. is a clinical-stage global biopharmaceutical company focused on developing transformative therapies for autoimmune diseases [3] - The company will present at the Guggenheim Emerging Outlook: Biotech Summit 2026 on February 11, 2026 [1] Company Overview - Zenas aims to lead in the development and commercialization of therapies for autoimmune diseases, leveraging an experienced leadership team and a disciplined product candidate acquisition strategy [3] - The company is advancing two late-stage product candidates: obexelimab and orelabrutinib [3] - Obexelimab is a bifunctional monoclonal antibody targeting CD19 and FcγRIIb, designed to inhibit pathogenic B cells without depleting them [3] - Orelabrutinib is a selective CNS-penetrant oral small molecule BTK inhibitor that targets pathogenic B cells in both peripheral and central nervous systems [3] - Zenas also has earlier stage programs, including ZB021, an oral IL-17AA/AF inhibitor, and ZB022, a brain-penetrant TYK2 inhibitor [3]

Core Insights - Sana Biotechnology, Inc. focuses on developing ex vivo hypoimmune therapy and in vivo fusogen-based delivery systems to treat cancer and autoimmune diseases [1] Company Overview - The company is engaged in innovative biotechnological solutions aimed at addressing significant medical challenges in oncology and autoimmune disorders [1] Technology and Innovation - Sana's ex vivo platform is designed to enhance therapeutic efficacy by utilizing hypoimmune strategies, which may improve patient outcomes in complex diseases [1]

Core Viewpoint - SAB Biotherapeutics, Inc. has appointed David Zaccardelli, Pharm.D. as Chair of the Board and Rita Jain, M.D. as an independent director, which is expected to enhance the company's strategic direction and growth potential in developing therapies for autoimmune diseases, particularly Type 1 Diabetes (T1D) [2][4][5]. Group 1: Appointments and Expertise - David Zaccardelli brings over 20 years of biopharmaceutical experience, having successfully led companies from clinical stages to commercialization, including the launch of Ohtuvayre, a notable biotech product [4][8]. - Rita Jain has more than two decades of leadership experience in biopharmaceutical development, particularly in autoimmune and inflammatory diseases, and has held key positions in various companies [6][9]. Group 2: Company Focus and Product Development - SAB Biotherapeutics is focused on developing a fully human anti-thymocyte immunoglobulin (hATG) for T1D and other autoimmune diseases, with its lead candidate, SAB-142, aiming to modify the disease progression in T1D patients [2][10]. - The company utilizes advanced genetic engineering and proprietary technology to produce high-potency human immunoglobulin G (hIgG) without the need for human donors, which positions it to address significant unmet medical needs [10].

Core Insights - Galapagos NV announced positive topline results from two Phase 3-enabling studies for GLPG3667, a selective TYK2 inhibitor, showing significant clinical benefits in dermatomyositis but not in systemic lupus erythematosus [1][3][4] Dermatomyositis Study (GALARISSO) - The GALARISSO study met its primary endpoint, demonstrating a statistically significant clinical benefit with a Total Improvement Score (TIS) of 14.26 at Week 24 (p=0.0848) compared to placebo [2][4] - GLPG3667 also showed meaningful improvements on secondary endpoints, including TIS20, TIS40, TIS60, and m-CDASI-A, with a favorable safety profile throughout the 24-week treatment period [2][4] Systemic Lupus Erythematosus Study (GALACELA) - In the GALACELA study, GLPG3667 did not achieve statistical significance for the primary endpoint (SLE responder index SRI-4) at Week 32, despite showing numerical improvements on several secondary endpoints, particularly skin-related outcomes [3][4] - The ongoing GALACELA study is expected to provide final Week 48 data in the second quarter of 2026, which will be crucial for assessing the overall evidence and determining next steps for the SLE program [3][4] Strategic Development - The company plans to evaluate all strategic alternatives, including resuming its partnering process to accelerate GLPG3667's development in dermatomyositis and exploring opportunities in other severe autoimmune diseases [1][4][5] - Gilead has temporarily waived certain rights under their collaboration agreement, allowing Galapagos to pursue external partnership opportunities for GLPG3667 [5] Background on Diseases - Dermatomyositis (DM) is a rare autoimmune disorder characterized by severe muscle weakness and skin manifestations, with a high unmet need for effective treatments [9] - Systemic lupus erythematosus (SLE) is a chronic autoimmune disease affecting multiple organ systems, with current treatments often associated with partial efficacy and significant toxicities [10]

Core Insights - TG Therapeutics, Inc. ranked 27th on the Deloitte Technology Fast 500™, highlighting its status as one of the fastest-growing technology companies in North America [1][4] - The company's growth from fiscal years 2021 to 2024 was primarily driven by revenues from BRIUMVI®, which received FDA approval in December 2022 for treating relapsing forms of multiple sclerosis [2][3] Company Overview - TG Therapeutics is a biopharmaceutical company focused on developing and commercializing novel treatments for B-cell diseases, with BRIUMVI® being a key product approved for multiple sclerosis [7] - BRIUMVI® is a monoclonal antibody designed to target CD20-expressing B-cells, facilitating efficient B-cell depletion at low doses [9] Financial Performance - The company’s revenue growth is attributed to the successful adoption of BRIUMVI®, reflecting the trust from patients and healthcare providers [3][2] - To qualify for the Deloitte Technology Fast 500™, companies must demonstrate significant revenue growth, with TG Therapeutics achieving a growth rate of 50% or greater [5][4] Industry Context - The Deloitte Technology Fast 500™ has been recognizing fast-growing companies for 31 years, covering various sectors including technology, media, and life sciences [4] - The biopharmaceutical industry is increasingly focused on innovative treatments for autoimmune diseases, with BRIUMVI® positioned as a significant player in the market for multiple sclerosis [7][9]

Core Insights - Jade Biosciences, Inc. is advancing its investigational anti-APRIL monoclonal antibody, JADE101, for the treatment of immunoglobulin A nephropathy (IgAN), presenting new data at the ASN Kidney Week 2025 [1][2] Group 1: Product Overview - JADE101 selectively inhibits APRIL, a key factor in IgAN, which can lead to end-stage kidney disease [2] - The drug is designed for subcutaneous dosing, with a favorable pharmacokinetic and pharmacodynamic profile demonstrated in non-human primates (NHPs) [2][7] - JADE101 has shown a serum half-life of approximately 27 days, allowing for infrequent dosing [7] Group 2: Clinical Development - A Phase 1 trial is currently evaluating JADE101 in healthy volunteers, with interim data expected in the first half of 2026 to inform future studies in IgAN patients [2][8] - The trial aims to establish optimal dosing based on biomarker responses that correlate with clinical activity in IgAN patients [8] Group 3: Safety and Efficacy Data - Preclinical studies indicate that JADE101 is well tolerated in NHPs, with no observed adverse effects at the highest doses tested [5] - JADE101 treatment resulted in significant reductions in serum immunoglobulins, including IgA and IgM reductions of approximately 55–68% and 62–75%, respectively, without broad immunosuppression [5][6] - The drug demonstrated no off-target binding and did not affect immune cell populations, supporting its potential as a safe treatment option [5][6] Group 4: Biomarker Insights - Analyses suggest that pharmacokinetic and biomarker responses in healthy volunteers can predict therapeutic outcomes in IgAN patients [6][11] - The depth and duration of APRIL suppression are linked to reductions in total IgA and proteinuria, which are associated with preserving kidney function [6][11] Group 5: Company Background - Jade Biosciences focuses on developing therapies for autoimmune diseases, with JADE101 as its lead candidate targeting APRIL [9] - The company also has other candidates in its pipeline, including JADE201 and JADE-003, currently in preclinical development [9]

Core Insights - Boehringer Ingelheim has licensed a pre-clinical program from Kyowa Kirin to develop a potential first-in-class small molecule for autoimmune diseases [1][3] - Autoimmune diseases affect approximately one in ten people globally, highlighting a significant unmet medical need for effective treatments [2][6] - The agreement allows Boehringer Ingelheim exclusive worldwide rights to develop the small molecule, with Kyowa Kirin eligible to receive up to €640 million in various payments and royalties [3] Company Overview - Boehringer Ingelheim is a biopharmaceutical company focused on human and animal health, emphasizing innovative therapies for high unmet medical needs [4] - Kyowa Kirin is a Japan-based Global Specialty Pharmaceutical Company with over 70 years of experience in drug discovery and biotechnology innovation [5]