Latest news with #APRIL
Pink Villa
2 days ago
- Entertainment
- Pink Villa
Lee Naeun to return with major role in The Defects: Everything to know about Won Jin Ah starrer and APRIL disbandment
Lee Naeun is officially returning to television with her first major role. On July 18, Namoo Actors confirmed that the idol-turned-actress has been cast in ENA's new action thriller The Defects. The drama is set to premiere on July 21, 2025. This marks her first major public appearance in several years following a long hiatus. Lee Naeun returns amid past APRIL controversy Lee Naeun's return has taken many by surprise. In 2020, she became embroiled in a high-profile controversy. Former APRIL member Lee Hyunjoo alleged she had been b*llied during her time in the group. A post made by someone claiming to be Hyunjoo's younger brother went viral. He accused fellow members, including Naeun, of contributing to the singer's departure. Additional anonymous posts surfaced online, intensifying the accusations. At the time, APRIL's agency DSP Media denied all claims. Naeun herself issued a personal statement through the official fan café, strongly refuting the allegations. Despite maintaining her innocence, the backlash led to Naeun suspending all activities. In 2022, APRIL officially disbanded. Lee Naeun's role in The Defects The Defects follows a group of children who narrowly survive death after being betrayed by their adoptive families. Thrown into a world of abandonment and violence, these children form a close-knit group. They fight for survival while seeking revenge against the adults who failed them. Lee Naeun plays Somi, one of the abandoned children. She, despite her tragic past, exudes strength and positivity. Somi draws hope from her bond with Ahyeon, the group's leader, portrayed by actress Won Jin Ah. The role marks a shift for Naeun, who is known for lighter, youth-centered roles, making this project her most emotionally intense yet. Naeun's casting receives mixed reactions from the public News of Naeun's casting has quickly spread online, with many viewers expressing shock at her return. Although she made brief appearances in Crash and Flex X Cop in 2024, they were limited to guest roles. This time, however, she takes on a supporting role with significantly more screen time. It prompted netizens to take greater notice of her return. Some fans are cautiously optimistic about her comeback. However, others remain skeptical due to the unresolved nature of the past controversy. Whether this marks a fresh start or sparks further debate remains to be seen.
Business Wire
30-06-2025
- Business
- Business Wire
Aurinia Announces Positive Results from Phase 1 Study of Aritinercept (AUR200)
ROCKVILLE, Md. & EDMONTON, Alberta--(BUSINESS WIRE)--Aurinia Pharmaceuticals Inc. (NASDAQ: AUPH) today announced positive results from a Phase 1 single-ascending-dose (SAD) study of aritinercept (AUR200), its dual inhibitor of B cell-activating factor (BAFF) and a proliferation-inducing ligand (APRIL). The study investigated aritinercept doses of 5 mg, 25 mg, 75 mg, 150 mg, 225 mg and 300 mg and placebo, administered by subcutaneous injection, in 61 healthy subjects. Aritinercept was well tolerated at all dose levels tested. There were no treatment-related Grade ≥3 adverse events, there were no treatment‑related serious adverse events (SAEs) and there were no discontinuations due to treatment-related adverse events. Adverse events that occurred in more than one subject included injection site reactions (24% aritinercept, 13% placebo), headache (11% aritinercept, 7% placebo), upper respiratory tract infection (7% aritinercept, 0% placebo) and back pain (4% aritinercept, 0% placebo). All injection site reactions were Grade 1. Single doses of aritinercept led to robust and long-lasting reductions in immunoglobulins (antibodies). Specifically, mean reductions from baseline to Day 28 of up to 48%, 55% and 20% were observed for immunoglobulin A (IgA), immunoglobulin M (IgM) and immunoglobulin G (IgG), respectively. 'Dual inhibition of BAFF and APRIL to modulate B cells, including plasma cells, holds great promise in the treatment of a wide range of autoimmune immune diseases where these cells produce disease-causing autoantibodies,' said Dr. Greg Keenan, Chief Medical Officer of Aurinia. 'Based on today's positive results, which indicate robust and long‑lasting pharmacodynamic effects supportive of once-monthly dosing, we plan to initiate clinical studies of aritinercept in at least two autoimmune diseases in the second half of this year.' Webcast & Conference Call Details A webcast and conference call will be hosted today, June 30, at 8:30 a.m. ET. The link to the webcast is available here. To join the conference call, please dial 877-407-9170/+1 201-493-6756. Click here for participant International Toll-Free access numbers. A replay of the webcast will be available on Aurinia's website. About Aurinia Aurinia is a biopharmaceutical company focused on delivering therapies to people living with autoimmune diseases with high unmet medical needs. In January 2021, the Company introduced LUPKYNIS ® (voclosporin), the first FDA‑approved oral therapy for the treatment of adult patients with active lupus nephritis. Aurinia is also developing aritinercept (AUR200), a dual inhibitor of B cell-activating factor (BAFF) and a proliferation-inducing ligand (APRIL) for the potential treatment of autoimmune diseases. Forward-Looking Statements This press release contains forward-looking information within the meaning of applicable Canadian securities law and forward-looking statements within the meaning of applicable U.S. securities law. We caution investors that forward-looking statements are based on management's expectations and assumptions as of the date of this press release and involve substantial risks and uncertainties that could cause the actual outcomes to differ materially from what we currently expect. These risks and uncertainties include, but are not limited to, those associated with the development of aritinercept and other risks and uncertainties identified in our filings with the U.S. Securities and Exchange Commission. Forward-looking statements in this press release apply only as of the date made, and we undertake no obligation to update or revise any forward-looking statements to reflect subsequent events or circumstances. Additional information related to Aurinia, including a detailed list of the risks and uncertainties affecting Aurinia and its business, can be found in Aurinia's most recent Annual Report on Form 10-K and its other public available filings available by accessing the Canadian Securities Administrators' System for Electronic Document Analysis and Retrieval (SEDAR) website at or the U.S. Securities and Exchange Commission's Electronic Document Gathering and Retrieval System (EDGAR) website at and on Aurinia's website at
Business Insider
26-06-2025
- Business
- Business Insider
Vor Bio enters into license pact witht RemeGen for late-stage autoimmune asset
Vor Bio (VOR) and RemeGen announced entry into an exclusive license agreement granting Vor Bio global rights to develop and commercialize telitacicept, a novel dual-target fusion protein approved in China for generalized myasthenia gravis, systemic lupus erythematosus, and rheumatoid arthritis. Under the terms of the agreement, Vor Bio will pay RemeGen an initial payment of $125M consisting of an upfront payment of $45M as well as $80M of warrants to purchase common stock with an exercise price of $0.0001 per share. The agreement also provides for potential regulatory and commercial milestones exceeding $4B, in addition to tiered royalties. Telitacicept is a novel, investigational fusion protein that targets key immune pathways involved in autoimmune disease. By selectively inhibiting BlyS and APRIL – cytokines critical to B cell survival – telitacicept reduces autoreactive B cells and autoantibody production. RemeGen is conducting a global Phase 3 clinical trial which is now enrolling in the United States, Europe, and South America, with initial results expected in the first half of 2027. Confident Investing Starts Here:
Business Wire
23-06-2025
- Business
- Business Wire
Vertex and Ono Pharmaceutical Announce Strategic Agreement to Develop and Commercialize Povetacicept in Japan and South Korea
BOSTON & OSAKA, Japan--(BUSINESS WIRE)-- Vertex Pharmaceuticals Incorporated (Nasdaq: VRTX) and Ono Pharmaceutical Co., Ltd. (OTCMKTS: OPHLY) today announced an exclusive collaboration and license agreement for the development and commercialization of Vertex's povetacicept in Japan and South Korea. Povetacicept is a recombinant fusion protein therapeutic and dual antagonist of the BAFF (B cell activating factor) and APRIL (a proliferation inducing ligand) cytokines with best-in-class potential being studied for the treatment of immunoglobulin A nephropathy (IgAN), primary membranous nephropathy (pMN) and other B cell-mediated diseases. Under the terms of the agreement, Vertex will receive an upfront payment, as well as certain regulatory and commercial milestone payments and tiered royalties. Ono will utilize its extensive development expertise to help advance Vertex's clinical trials for povetacicept and will be responsible for obtaining marketing authorizations in Japan and South Korea. Following approval, Ono will be solely responsible for commercializing povetacicept in these regions. The agreement includes povetacicept for both IgAN and pMN, with the potential to add other indications. 'Ono is a proven leader in Japan and South Korea, bringing established local relationships, infrastructure and nephrology expertise that make them a perfect partner for Vertex as we look to deliver povetacicept to the thousands of potential patients in these countries,' said Reshma Kewalramani, M.D., Chief Executive Officer and President of Vertex. 'We are very pleased to partner with Ono and look forward to close collaboration as we continue to advance this potentially best-in-class treatment for IgAN, pMN and other serious B cell-mediated diseases.' 'Vertex has a strong track record of developing innovative therapies for serious diseases. Through this strategic partnership, we can strengthen our late-stage pipeline in the immunology field, which is a key focus area for Ono,' said Toichi Takino, Representative Director, President and Chief Operating Officer of Ono. 'We look forward to collaborating with Vertex to provide this new therapeutic option for patients with IgAN and other autoimmune diseases in Japan and South Korea, and to maximize the value of this treatment.' About Povetacicept Povetacicept is a recombinant fusion protein therapeutic and a dual antagonist of the BAFF (B cell activating factor) and APRIL (a proliferation inducing ligand) cytokines, which play key roles in pathogenesis of multiple autoimmune diseases via their roles in the activation, differentiation and/or survival of B cells, T cells and innate immune cells. Based upon an engineered TACI (transmembrane activator and calcium modulator ligand interactor) domain, povetacicept has higher binding affinity and greater potency in preclinical studies versus other inhibitors of BAFF and/or APRIL alone and has demonstrated potential best-in-class efficacy in a clinical trial in patients with IgA nephropathy and primary membranous nephropathy. Povetacicept is also in development for multiple serious B cell-mediated diseases including other autoimmune kidney diseases and autoimmune cytopenias. About IgA Nephropathy (IgAN) IgAN is a serious, progressive, life-threatening, B cell-mediated chronic kidney disease that is the most common cause of primary (idiopathic) glomerulonephritis, affecting approximately 300,000 people in the United States and Europe. It is estimated that there are approximately 33,000 diagnosed patients in Japan. IgAN results from deposition of circulating immune complexes consisting of immunoglobulins and galactose-deficient immunoglobulin A (Gd-IgA1) in the renal glomerular mesangium, triggering kidney injury and fibrosis. Up to 72% of adult IgAN patients progress to end-stage renal disease within 20 years. There are no approved therapies that specifically target the underlying cause of IgAN. About Primary Membranous Nephropathy (pMN) Primary membranous nephropathy is a serious, progressive, life-threatening B cell-mediated chronic kidney disease affecting people worldwide, with approximately 150,000 people diagnosed in the U.S. and Europe. It is estimated that there are approximately 6,000 diagnosed patients with pMN in Japan. pMN is a rare glomerular disease that occurs when the body generates an abnormal immune response, including autoantibodies, against proteins that are part of the kidney. Autoantibodies trigger damage and inflammation, especially within the glomeruli (the parts of the kidney that filter blood), impairing the kidneys' ability to properly filter waste and fluid, eventually causing progressive loss of kidney function. There are no approved therapies that specifically target the underlying cause of pMN. About RAINIER RAINIER is a global Phase 3 pivotal trial of povetacicept 80 mg vs. placebo on top of standard of care in approximately 480 people with IgAN. The study is designed to have a pre-planned interim analysis evaluating urine protein to creatinine ratio (UPCR) for the povetacicept arm versus placebo after a certain number of patients reach 36 weeks of treatment. If positive, the interim analysis may serve as the basis for Vertex to seek accelerated approval in the U.S. Final analysis will occur at two years of treatment, with a primary endpoint of total eGFR slope through Week 104. The Phase 3 clinical trial is underway in multiple regions, including the U.S., EU and Asia. Specifically, Japanese and South Korean regulatory authorities have approved the Clinical Trial Application (CTA) for RAINIER, where the Phase 3 trial is underway. About RUBY-3 RUBY-3 is an ongoing, multiple ascending dose, multi-cohort, open label, Phase 1/2 basket study of povetacicept in autoimmune glomerulonephritis, including IgAN, primary membranous nephropathy, lupus nephritis and ANCA-associated vasculitis with glomerulonephritis where povetacicept is being administered subcutaneously for up to 104 weeks. About Vertex Vertex is a global biotechnology company that invests in scientific innovation to create transformative medicines for people with serious diseases and conditions. The company has approved therapies for cystic fibrosis, sickle cell disease, transfusion-dependent beta thalassemia and acute pain, and it continues to advance clinical and research programs in these areas. Vertex also has a robust clinical pipeline of investigational therapies across a range of modalities in other serious diseases where it has deep insight into causal human biology, including neuropathic pain, APOL1-mediated kidney disease, IgA nephropathy, primary membranous nephropathy, autosomal dominant polycystic kidney disease, type 1 diabetes and myotonic dystrophy type 1. Vertex was founded in 1989 and has its global headquarters in Boston, with international headquarters in London. Additionally, the company has research and development sites and commercial offices in North America, Europe, Australia, Latin America and the Middle East. Vertex is consistently recognized as one of the industry's top places to work, including 15 consecutive years on Science magazine's Top Employers list and one of Fortune's 100 Best Companies to Work For. For company updates and to learn more about Vertex's history of innovation, visit or follow us on LinkedIn, Facebook, Instagram, YouTube and X. About Ono Pharmaceutical Co., Ltd Ono Pharmaceutical Co., Ltd. delivers innovative therapies for patients worldwide. Upholding its philosophy of 'Dedicated to the Fight against Disease and Pain,' Ono targets areas with unmet medical needs including oncology, immunology, and neurology, and fosters partnerships with academic and biotech organizations to accelerate drug discovery. Through its affiliate, Deciphera Pharmaceuticals, Ono is accelerating clinical development and commercial operations in the US and Europe to drive global business expansion and further its commitment to patient care. For more information, please visit the company's website at Vertex Forward-Looking Statements This press release contains forward-looking statements as defined in the Private Securities Litigation Reform Act of 1995, as amended, including, without limitation, statements by Reshma Kewalramani M.D., and Toichi Takino, in this press release, and statements about the terms of and expectations for Vertex's collaboration with Ono, statements about potential benefits and results that may be achieved through the collaboration, statements regarding the future activities of the parties pursuant to the collaboration, including Ono's help to advance clinical trials and Ono's responsibility to obtain marketing authorizations in Japan and South Korea and to commercialize povetacicept in the regions, statements regarding upfront and milestone payments, and potential royalties on future products, and statements about Vertex's plans and expectations for the RAINIER and RUBY-3 clinical trials and potential plans to seek accelerated approval in the U.S. based on interim analysis from the RAINIER trial. While Vertex believes the forward-looking statements contained in this press release are accurate, these forward-looking statements represent the company's beliefs only as of the date of this press release and there are a number of risks and uncertainties that could cause actual events or results to differ materially from those expressed or implied by such forward-looking statements. Those risks and uncertainties include, among other things, that the anticipated benefits and potential of the collaboration between Vertex and Ono may not be achieved on the anticipated timeline, or at all, that data may not support further development of the therapies subject to the collaboration due to safety, efficacy, or other reasons, and other risks listed under the heading 'Risk Factors' in Vertex's annual report filed with the Securities and Exchange Commission (SEC) and available through Vertex's website at and on the SEC's website at You should not place undue reliance on these statements. Vertex disclaims any obligation to update the information contained in this press release as new information becomes available. (VRTX-GEN) Ono Forward-Looking Statements In this press release, statements made with respect to current plans, estimates, strategies and beliefs, and other statements that are not historical facts are forward-looking statements about the future performance of the company. These statements are based on current assumptions and beliefs in light of the information currently available and involve known and unknown risks and uncertainties. A number of factors could cause actual results to differ materially from those discussed in the forward-looking statements. Such factors include, but are not limited to: (i) changes in the business environment in the pharmaceutical market and amendments to relevant laws and regulations, (ii) disruptions to product supply due to stagnation or delays in production caused by natural disasters, fires, etc., (iii) the possibility that sales activities for new and existing products may not achieve the expected results, (iv) the emergence of new side effects in post-marketing drugs, and (v) infringements of intellectual property rights by third parties. Information about pharmaceutical products included in this press release is not intended to constitute an advertisement or medical advice.
Yahoo
09-06-2025
- Business
- Yahoo
Jade Biosciences Presents JADE101 Preclinical Data at the 62nd European Renal Association Congress Demonstrating Potential for Best-in-Class Profile in IgA Nephropathy
SAN FRANCISCO and VANCOUVER, British Columbia, June 09, 2025 (GLOBE NEWSWIRE) -- Jade Biosciences, Inc. ('Jade') (Nasdaq: JBIO), a biotechnology company focused on developing best-in-class therapies for autoimmune diseases, today announced a detailed preclinical characterization of JADE101, its anti-A Proliferation-Inducing Ligand (APRIL) monoclonal antibody, in development for IgA nephropathy (IgAN), a chronic autoimmune kidney disease. The findings, presented during an oral session at the 62nd European Renal Association (ERA) Congress, support advancement of JADE101 into a planned healthy volunteer study in the second half of 2025. 'IgA nephropathy often begins in young adulthood and typically requires lifelong treatment, yet current treatment options have limitations in efficacy and ease of use,' said Andrew King, BVMS, Ph.D., Chief Scientific Officer and Head of R&D at Jade Biosciences. 'Jade's preclinical data presented at ERA demonstrate JADE101's potential to be a best-in-class disease-modifying therapy. JADE101 has the potential to fully capture the efficacy available to the anti-APRIL mechanism with convenient, infrequent dosing. We believe this profile could translate into meaningful long-term benefit for patients, and we look forward to advancing this promising candidate into the clinic later this year.' Summary of Jade Biosciences' ERA 2025 Presentation Jade's presentation at ERA focused on a comprehensive preclinical characterization of JADE101, a fully human monoclonal antibody targeting APRIL, designed to address key limitations of earlier molecules in this class. JADE101 incorporates a YTE-modified IgG1 backbone and was engineered to improve target affinity, extend pharmacokinetic exposure, and reduce risks associated with immune complex formation and rapid clearance. The molecular design of JADE101 prolonged systemic exposure that delivers sustained target engagement, with a goal of supporting clinical dosing intervals of eight weeks or potentially longer. JADE101 was compared with sibeprenlimab, an investigational late-stage anti-APRIL monoclonal antibody, manufactured from publicly available sequences. A YTE-engineered version of sibeprenlimab was also tested to isolate the impact of Fc modification on pharmacokinetic profiles in non-human primates (NHPs). Key findings included: Ultra-high APRIL binding affinityJADE101 binds APRIL with femtomolar affinity (approximately 50 fM), over 750-fold higher affinity than sibeprenlimab. This higher binding affinity has the potential to enable complete suppression of APRIL at low plasma concentrations of JADE101 to deliver the full efficacy available to the anti-APRIL mechanism and further support an extended dosing interval. Potent inhibition of APRIL signaling through BCMA and TACIJADE101 demonstrated potent blockade of APRIL binding and signaling through its receptors in in vitro assays, including assays designed to model mechanistic aspects of the therapeutic benefit of APRIL inhibition in IgAN. In competitive binding assays, JADE101 fully inhibited APRIL binding to its receptors BCMA and TACI with IC50 values of 1.9 nM and 1.03 nM, respectively. In cell-based reporter assays, JADE101 blocked APRIL-induced signaling through BCMA (IC50 = 5.97 nM) and TACI (IC50 = 0.22 nM). JADE101 also potently reduced human plasma cell proliferation and IgA secretion in vitro. Extended pharmacokinetics and deep, sustained IgA suppression in NHPsIn NHPs, a single 30 mg/kg intravenous dose of JADE101 demonstrated an approximately 27-day half-life, nearly 4 times longer than sibeprenlimab at the same dose, and maintained linear clearance down to approximately 2 µg/mL, well below the approximately 40 µg/mL target-mediated drug disposition (TMDD) threshold observed for sibeprenlimab. This pharmacokinetic profile translated into sustained IgA suppression for more than 100 days after a single 30 mg/kg dose in NHPs. Notably, JADE101 dosed at just 4 mg/kg (7.5-fold lower) achieved deeper and more durable IgA reductions in NHPs than both sibeprenlimab and YTE-modified sibeprenlimab dosed at 30 mg/kg. Favorable subcutaneous profile in NHPsFollowing a single 100 mg/kg subcutaneous dose, JADE101 exhibited high bioavailability and a linear half-life exceeding 30 days in NHPs, supporting the potential for convenient, infrequent subcutaneous dosing in clinical settings. Designed to reduce risk of high molecular weight immune complex formationJADE101 binds a novel epitope on trimeric APRIL and was specifically selected to avoid the formation of high molecular weight immune complexes, that can occur with the first-generation anti-APRIL monoclonal antibodies. Immune complexes have potential to be associated with an increased risk of immunogenicity and tissue deposition, and to result in accelerated drug clearance. By avoiding their formation, JADE101 may mitigate these risks, supporting more consistent pharmacokinetics and sustained exposure over time. Jade plans to initiate a study of JADE101 in healthy volunteers in the second half of 2025. The study will evaluate safety, tolerability, pharmacokinetics, pharmacodynamics, and suppression of key biomarkers including APRIL and IgA. Interim data are expected in the first half of 2026 and are anticipated to guide dose and dose interval selection for future JADE101 studies in patients with IgAN. Conference Call and Webcast Jade Biosciences will host a conference call and webcast today, Monday, June 9, 2025, at 8:00 a.m. ET to review the JADE101 data presented at ERA 2025. Investors and the public are invited to join the live webcast by registering on the 'Events and Presentations' page of To join the conference call, participants must register here. Upon registering, dial-in details and a unique PIN will be provided. A replay of the webcast will be available shortly after the call concludes. About IgA nephropathy (IgAN) IgAN is a chronic autoimmune kidney disease that affects approximately 169,000 people in the U.S. and is most often diagnosed in young adults. The disease is characterized by the deposition of pathogenic IgA-containing immune complexes in the kidneys. These deposits can lead to increased protein in the urine, also known as proteinuria, declining kidney function, and potentially end-stage kidney disease requiring dialysis or a transplant. IgAN often requires lifelong treatment to preserve kidney function and prevent progression to kidney failure. About JADE101 JADE101 is an anti-APRIL monoclonal antibody being developed for the treatment of IgAN. By targeting APRIL, a protein involved in the overproduction of IgA, JADE101 aims to reduce the levels of disease-driving IgA, decrease proteinuria, and preserve kidney function. Engineered with half-life extension technology, JADE101 is designed for dosing at intervals of at least eight weeks, offering the potential for durable clinical activity and improved patient convenience, particularly important for a condition often diagnosed in young adulthood and potentially requiring life-long treatment. About Jade Biosciences, Inc. Jade Biosciences is focused on developing best-in-class therapies to address critical unmet needs in autoimmune diseases. Its lead candidate, JADE101, targets the cytokine APRIL for the treatment of immunoglobulin A nephropathy, with initiation of a first-in-human clinical trial expected in the second half of 2025. Jade's pipeline also includes a second development candidate, JADE201, and an undisclosed antibody discovery program, JADE-003, both currently in preclinical development. Jade was launched based on assets licensed from Paragon Therapeutics, an antibody discovery engine founded by Fairmount. For more information, visit and follow the Company on LinkedIn. Forward-Looking Statements Certain statements in this communication, 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 Private Securities Litigation Reform Act of 1995. These forward-looking statements include, but are not limited to, express or implied statements relating to Jade's expectations, hopes, beliefs, intentions or strategies regarding the future of its pipeline and business including, without limitation, Jade's ability to achieve the expected benefits or opportunities with respect to JADE101, JADE201 and the JADE-003 program, including without limitation the expected timelines for JADE101 entering the clinic and interim data from such trial, the potential of Jade's product candidates to become best-in-class therapies and their potential therapeutic uses, efficacy, dosing, safety and market opportunities. The words "opportunity," "potential," "milestones," "pipeline," "can," "goal," "strategy," "target," "anticipate," "achieve," "believe," "contemplate," "continue," "could," "estimate," "expect," "intends," "may," "plan," "possible," "project," "should," "will," "would" and similar expressions (including the negatives of these terms or variations of them) may identify forward-looking statements, but the absence of these words does not mean that a statement is not forward-looking. These forward-looking statements are based on current expectations and beliefs concerning future developments and their potential effects. There can be no assurance that future developments affecting Jade will be those that have been anticipated. These forward-looking statements involve a number of risks, uncertainties (some of which are beyond Jade's control) or other assumptions that may cause actual results or performance to be materially different from those expressed or implied by these forward-looking statements. These risks and uncertainties include, but are not limited to, the risks that the planned trial of JADE101 and any future clinical trials may be delayed or may not demonstrate safety and/or efficacy; Jade may experience unanticipated costs, difficulties or delays in the product development process; Jade's product candidates may fail in development, may not receive required regulatory approvals, or may be delayed to a point where they are not commercially viable; regulatory agencies may impose additional requirements or delay the initiation of clinical trials; risks associated with Jade's dependence on third-party vendors for the development, manufacture and supply of JADE101; and the other risks, uncertainties and factors more fully described in Jade's most recent filings with the Securities and Exchange Commission (including the definitive proxy statement/prospectus filed on Form S-4, most recently amended on March 24, 2025 and declared effective on March 25, 2025). Should one or more of these risks or uncertainties materialize, or should any of Jade's assumptions prove incorrect, actual results may vary in material respects from those projected in these forward-looking statements. You should not place undue reliance on forward-looking statements in this communication, which speak only as of the date they are made and are qualified in their entirety by reference to the cautionary statements herein. Jade does not undertake or accept any duty to release publicly any updates or revisions to any forward-looking statements. This communication does not purport to summarize all of the conditions, risks and other attributes of an investment in Jade. Jade Biosciences Media & Investor Contacts Priyanka ShahEmail: Media@ Email: IR@ Phone: 908-447-6134Error in retrieving data Sign in to access your portfolio Error in retrieving data Error in retrieving data Error in retrieving data Error in retrieving data
