Core Insights - Jade Biosciences, Inc. reported significant advancements in its mission to develop best-in-class therapies for autoimmune diseases, highlighted by the presentation of preclinical data for its lead candidate, JADE101, and the introduction of a new candidate, JADE201 [2][4][10] Pipeline and Corporate Updates - JADE101 is a selective anti-APRIL monoclonal antibody targeting IgA nephropathy (IgAN), with favorable preclinical safety data presented at ASN Kidney Week 2025 [4][5] - The Phase 1 healthy volunteer study for JADE101 has been initiated, with interim biomarker data expected in the first half of 2026 to inform dosing strategies for patient trials [4][5] - JADE201, a half-life extended anti-BAFF-R monoclonal antibody, was introduced, with a first-in-human trial in rheumatoid arthritis anticipated to start in the first half of 2026 [4][10] - The company completed a $135 million private financing round, extending its cash runway into the first half of 2028 [2][7][11] Financial Results - As of September 30, 2025, Jade had cash, cash equivalents, and investments totaling $198.9 million, which increased to approximately $325.6 million post-financing [11] - Research and Development (R&D) expenses for Q3 2025 were $22.0 million, up from $13.6 million in Q3 2024, primarily due to increased personnel and clinical activity costs [11] - General and Administrative (G&A) expenses rose to $5.4 million in Q3 2025 from $1.4 million in Q3 2024, reflecting higher personnel-related costs [11] - The net loss for Q3 2025 was $25.2 million, compared to a net loss of $16.3 million in Q3 2024, driven by increased R&D and G&A expenses [11][17]

Summary of Jade Biosciences Conference Call Company Overview - **Company**: Jade Biosciences (NasdaqCM:JBIO) - **Focus**: Development of therapies for autoimmune diseases, recently formed in June 2024 - **Key Assets**: Acquired three assets from Paragon Therapeutics, specializing in high affinity antibodies with half-life extension technology [1][2] Core Programs - **Lead Program**: JADE101, an anti-APRIL therapy targeting IgA nephropathy - **Market Potential**: Estimated at over $10 billion in the US [2] - **Mechanism**: Disease-modifying potential without unnecessary immunosuppression - **Dosing Schedule**: Aiming for one injection every eight weeks [2][4] - **Phase I Study**: Initiated with first cohort dosed, expected readout in the first half of next year [2][4] - **Second Program**: JADE201, a BAFF receptor targeting antibody - **Indication**: Initially targeting rheumatoid arthritis [3] - **Development Timeline**: First trial expected in the first half of next year [3] - **Third Program**: JADE03, details not extensively discussed, expected to enter the clinic in the first half of 2027 [4] Financial Position - **Funding**: - Initial reverse merger raised $300 million - Additional PIPE financing brought in $135 million [4] - **Cash Runway**: Pro forma cash position of approximately $356 million, expected to last into the first half of 2028 [42] Treatment Landscape for IgA Nephropathy - **Current Treatments**: Historically involved ACE inhibitors and steroids, evolving towards new therapies [6][7] - **KDIGO Guidelines**: New guidelines recommend treating all patients with agents that deplete pathogenic IgA and achieving ambitious proteinuria targets [8][9] - **Future Expectations**: Selective anti-APRIL therapies expected to become frontline treatments [8][9] Clinical Insights - **Biomarker Richness**: IgA nephropathy is biomarker-rich, aiding in the prediction of clinical efficacy [3][24] - **Phase III Trials**: Initial data from phase III trials of other therapies show promising results, with selective anti-APRIL showing a 51% reduction in proteinuria [12][20] JADE101 Design and Mechanism - **Potency**: JADE101 designed to have ultra-high binding affinity to APRIL, significantly higher than existing therapies [14][16] - **Half-Life Extension**: Incorporates YTE mutation for extended plasma exposure, aiming for convenient dosing [15][16] - **Clinical Activity**: Expected to provide significant clinical activity with minimal dosing frequency [23] JADE201 Development - **Mechanism**: Designed to deplete B-cells while blocking compensatory BAFF upregulation, enhancing therapeutic efficacy [35][36] - **Phase I Study**: Planned for rheumatoid arthritis patients, focusing on safety and pharmacokinetics [38] Regulatory Environment - **FDA Engagement**: Ongoing discussions with the FDA regarding the potential for accelerated approval based on proteinuria as a surrogate endpoint [31][32] Conclusion - Jade Biosciences is positioned to capitalize on significant market opportunities in autoimmune therapies, with a strong financial foundation and promising clinical programs aimed at addressing unmet medical needs in IgA nephropathy and other autoimmune conditions [4][42]

Core Insights - Jade Biosciences, Inc. is focused on developing therapies for autoimmune diseases, with its lead candidate JADE101 targeting immunoglobulin A nephropathy (IgAN) [1][9] - JADE101 is an investigational anti-APRIL monoclonal antibody designed to inhibit APRIL, a key factor in IgAN progression, and is currently in a Phase 1 trial [2][8] Company Overview - Jade Biosciences is a clinical-stage biotechnology company that aims to address unmet needs in autoimmune diseases, with a pipeline that includes JADE201 and JADE-003 in preclinical development [9] - The company was established based on assets licensed from Paragon Therapeutics, an antibody discovery engine [9] Product Details - JADE101 is engineered for subcutaneous dosing and has shown a favorable pharmacokinetic and pharmacodynamic profile in non-human primates (NHPs), with a serum half-life of approximately 27 days [7] - Preclinical studies indicate that JADE101 effectively reduces immunoglobulin levels, including IgA and IgM by approximately 55–68% and 62–75% respectively, while maintaining a preserved vaccination response [5][6] Clinical Development - The ongoing Phase 1 trial is randomized, double-blind, and placebo-controlled, evaluating single ascending doses of JADE101 in healthy volunteers, with interim data expected in the first half of 2026 [2][8] - The trial aims to define optimal dosing intervals based on biomarker responses that correlate with clinical activity in IgAN patients [8][11] Safety and Efficacy - JADE101 has demonstrated a favorable safety profile in preclinical studies, with no off-target binding or significant adverse effects observed [5][6] - The pharmacokinetic and biomarker responses in healthy volunteers are expected to inform therapeutic responses in IgAN patients, linking APRIL suppression to reductions in total IgA and proteinuria [6][11]

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 - Jade Biosciences, Inc. is presenting new preclinical safety and translational data for its lead investigational candidate, JADE101, at the ASN Kidney Week 2025 [1][7] - JADE101 is designed to selectively inhibit APRIL in patients with immunoglobulin A nephropathy (IgAN), a serious autoimmune disease [2][4] - The company is currently conducting a Phase 1 clinical trial for JADE101, with interim data expected in the first half of 2026 [2][5] Company Overview - Jade Biosciences is a clinical-stage biotechnology company focused on developing therapies for autoimmune diseases, with JADE101 as its lead candidate targeting APRIL [6] - The company also has a second development candidate, JADE201, and an undisclosed antibody discovery program, JADE-003, both in preclinical development [6] Product Details - JADE101 is a fully human monoclonal antibody with ultra-high binding affinity for APRIL, engineered for extended half-life, showing a serum half-life of approximately 27 days in preclinical studies [4] - The therapy aims for infrequent and convenient subcutaneous dosing, which is crucial for patients often diagnosed in young adulthood [4] Clinical Trial Information - A Phase 1 randomized, double-blind, placebo-controlled trial is ongoing to evaluate single ascending subcutaneous doses of JADE101 in healthy adult volunteers [5] - The trial aims to define dose and dosing interval selection for later-stage studies based on biomarker responses [5] Presentation Details - JADE101's preclinical safety profile and translational framework will be highlighted in two poster sessions during ASN Kidney Week 2025 [3][7] - Presentations will occur on November 8, 2025, with specific titles and presenters listed [3]

Forward Looking Statements Certain statements in this presentation, 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 the expectations, hopes, beliefs, intentions or strategies of Jade Biosciences, Inc. ...

Core Insights - Jade Biosciences has introduced JADE201, an investigational monoclonal antibody targeting BAFF-R, aimed at improving treatment for autoimmune diseases by extending half-life and enhancing efficacy [1][3][4] Company Overview - Jade Biosciences is a clinical-stage biotechnology company focused on developing therapies for autoimmune diseases, with a portfolio that includes JADE201 and JADE101 [10] Product Details - JADE201 is designed with a dual mechanism of action, combining enhanced B cell depletion and blockade of BAFF-R signaling, which aims to provide deeper and more durable B-cell depletion with less frequent dosing [2][8] - The product incorporates afucosylation to enhance antibody-dependent cellular toxicity and a clinically validated Fc mutation to increase binding to the neonatal Fc receptor, thereby extending systemic exposure [2][4] Clinical Development - The clinical proof-of-concept for BAFF-R inhibition has been established by ianalumab, which has shown efficacy in multiple autoimmune indications [3] - JADE201 has demonstrated approximately a two-fold increase in half-life compared to ianalumab in non-human primate studies, supporting its potential for improved treatment convenience and efficacy [4] Future Plans - A first-in-human study for JADE201 in patients with rheumatoid arthritis is expected to begin in the first half of 2026, focusing on safety, tolerability, pharmacokinetics, and pharmacodynamics [5]

Core Viewpoint - Jade Biosciences, Inc. has announced a PIPE financing agreement expected to generate approximately $135 million in gross proceeds to fund its research and development efforts for autoimmune disease therapies [1][4]. Financing Details - The PIPE financing involves the sale of 13,368,164 shares of common stock at a price of $9.14 per share and pre-funded warrants for 1,402,092 shares at a price of $9.1399 per warrant [3]. - The transaction is anticipated to close on or about October 8, 2025, pending customary closing conditions [3]. Investor Participation - The financing attracted both new and existing investors, including notable firms such as Janus Henderson Investors, Fairmount, and RA Capital Management [2]. Use of Proceeds - The net proceeds from the PIPE financing will be utilized for research and development, general corporate expenses, and working capital needs, with expectations to fund operations into the first half of 2028 [4]. Company Overview - Jade Biosciences is focused on developing therapies for autoimmune diseases, with its lead candidate, JADE101, currently in a Phase 1 clinical trial for immunoglobulin A nephropathy (IgAN) [7]. - The company also has a second candidate, JADE201, and an undisclosed antibody discovery program in preclinical development [7].

Core Viewpoint - Jade Biosciences, Inc. has announced a PIPE financing agreement expected to generate approximately $135 million in gross proceeds to fund its research and development efforts for autoimmune disease therapies [1][4]. Group 1: Financing Details - The PIPE financing involves the sale of 13,368,164 shares of common stock at a price of $9.14 per share and pre-funded warrants for 1,402,092 shares at a price of $9.1399 per warrant [3]. - The transaction is expected to close on or about October 8, 2025, pending customary closing conditions [3]. Group 2: Investor Participation - The financing includes participation from both new and existing investors, such as Janus Henderson Investors, Fairmount, and RA Capital Management, among others [2]. Group 3: Use of Proceeds - The net proceeds from the PIPE financing will be used for research and development, general corporate expenses, and working capital needs, with expectations that current cash and securities will fund operations into the first half of 2028 [4]. Group 4: Company Overview - Jade Biosciences is focused on developing therapies for autoimmune diseases, with its lead candidate, JADE101, currently in a Phase 1 clinical trial for immunoglobulin A nephropathy [7]. - The company also has a second candidate, JADE201, and an undisclosed antibody discovery program, JADE-003, in preclinical development [7].

Core Insights - Jade Biosciences has initiated a Phase 1 clinical trial for JADE101, a monoclonal antibody targeting APRIL for the treatment of immunoglobulin A nephropathy (IgAN) [1][2] - The company anticipates interim clinical data in the first half of 2026, which will provide insights into dosing and biomarker responses [2][6] Company Overview - Jade Biosciences is a clinical-stage biotechnology firm focused on developing therapies for autoimmune diseases, with JADE101 as its lead candidate [4] - The company also has a second candidate, JADE201, and an undisclosed antibody discovery program, JADE-003, in preclinical development [4] Product Details - JADE101 is designed to selectively inhibit APRIL with ultra-high binding affinity and has shown sustained IgA suppression in preclinical studies [3][6] - The drug has a serum half-life of approximately 27 days, allowing for potentially infrequent subcutaneous dosing, which is beneficial for lifelong treatment [3][6] Clinical Trial Information - The Phase 1 trial is randomized, double-blind, and placebo-controlled, assessing safety, tolerability, pharmacokinetics, and pharmacodynamics of JADE101 [2][6] - The trial will evaluate single ascending subcutaneous doses in healthy adult volunteers [2][6]