JADE101 Phase 1 healthy volunteer trial ongoing; biomarker-rich interim data expected in the first half of 2026 Phase 2 clinical trial of JADE101 in patients with IgA nephropathy expected to begin mid-2026; preliminary data anticipated in 2027JADE201, a half-life extended afucosylated anti-BAFF receptor antibody, expected to advance into first-in-human study in rheumatoid arthritis patients in the second quarter of 2026; interim data anticipated in 2027Third development candidate, JADE301, nominated; curren ...

UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, D.C. 20549 FORM S-1 REGISTRATION STATEMENT UNDER THE SECURITIES ACT OF 1933 Jade Biosciences, Inc. (Exact name of registrant as specified in its charter) (State or other jurisdiction of incorporation or organization) Nevada 2836 83-137788 (Primary Standard Industrial Classification Code Number) 221 Crescent St., Building 23 Suite 105 Waltham, MA 02453 (781) 312-3013 (Address, including zip code, and telephone number, including area code, of regist ...

SAN FRANCISCO and VANCOUVER, British Columbia, Dec. 15, 2025 (GLOBE NEWSWIRE) -- Jade Biosciences, Inc. (“the Company” or “Jade”), (Nasdaq: JBIO), a clinical-stage biotechnology company focused on developing best-in-class therapies for autoimmune diseases, today announced that it has entered into a securities purchase agreement with BB Biotech for a private placement financing that is expected to result in gross proceeds of approximately $45 million to the Company, before offering expenses. Pursuant to the ...

Summary of Jade Biosciences Conference Call Company Overview - **Company**: Jade Biosciences (NasdaqCM:JBIO) - **Founded**: June 2024 - **Management Team**: Includes experienced members from Chinook Therapeutics, focusing on iGAN (IgA nephropathy) and autoimmune diseases - **Assets**: Three key assets acquired from Paragon, a protein engineering company Industry and Market Insights - **Lead Program**: Anti-APRIL for IgA nephropathy, a significant unmet medical need with a market opportunity exceeding $10 billion in the US alone [2] - **Clinical Development**: Initiated a Phase I study in August 2025, with results expected in the first half of 2026, aiming for rapid transition to patient studies [2][3] Key Programs and Developments - **JADE201**: A eufucosylated antibody targeting BAFF-R, expected to enter clinical trials in the first half of 2026 [2][3] - **Third Program**: Details not disclosed, anticipated to enter trials in the first half of 2027 [3] - **Financial Position**: Strong resources to fund trials through the first half of 2028 [3] Clinical Data and Efficacy - **ASN Conference Insights**: - iGAN is emerging as a large prospective market with promising data from competitors like Vera and Vertex [5][6] - Vertex reported a 64% reduction in proteinuria in Phase II studies, while Vera showed a 42% placebo-adjusted reduction [6] - Sibeprenlimab data indicated a 54% decrease in proteinuria over 12 months, highlighting the importance of APRIL inhibition [7][8] Mechanism of Action and Therapeutic Window - **APRIL vs. BAFF**: - Evidence suggests that APRIL inhibition alone provides significant disease-modifying benefits in iGAN without the need for BAFF [10][11] - Adding BAFF does not enhance clinical outcomes, indicating that iGAN is primarily driven by APRIL-responsive plasma cells [10][11] Regulatory Landscape - **FDA Considerations**: - The FDA is exploring new study designs to support innovation in iGAN, potentially shortening confirmatory study durations from two years to one year [30][31] - This shift is seen as beneficial for anti-APRIL therapies, which show early and significant eGFR improvements [30][31] Future Directions and Lifecycle Management - **Exploration of New Indications**: - Plans to investigate other autoimmune diseases, including IgM-mediated diseases and Sjogren's syndrome, based on the success of current programs [24][34] - JADE201's development will focus on generating safety and tolerability data in RA patients before expanding to other indications [34] Conclusion - Jade Biosciences is positioned to capitalize on significant market opportunities in the autoimmune disease space, particularly with its lead program targeting iGAN. The company is leveraging strong clinical data and a robust financial position to advance its pipeline and explore new therapeutic avenues.

As filed with the Securities and Exchange Commission on November 14, 2025 Registration No. 333- UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, D.C. 20549 FORM S-1 REGISTRATION STATEMENT UNDER THE SECURITIES ACT OF 1933 Jade Biosciences, Inc. (Exact name of registrant as specified in its charter) (State or other jurisdiction of incorporation or organization) Nevada 2836 83-137788 (Primary Standard Industrial Classification Code Number) (I.R.S. Employer Identification No.) 221 Crescent St., Buil ...

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 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]

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]