Group 1 - Jade Biosciences Inc. (NASDAQ:JBIO) is recognized as a growth stock with a Buy rating and a price target of $25, indicating its strategic positioning in the autoimmune market [1][3] - The company’s lead candidate, JADE101, is projected to generate $926 million in risk-adjusted revenue by 2037, specifically targeting immunoglobulin A nephropathy [1][3] - In Q3 2025, Jade Biosciences reported significant progress with JADE101 and introduced a new development program, JADE201, supported by a $135 million private placement that extends its cash runway into H1 2028 [2] Group 2 - JADE101 is a selective anti-APRIL monoclonal antibody that has shown promising preclinical data, demonstrating good tolerance in non-human primates and establishing a no-observed-adverse-effect level [3] - The drug has exhibited reversible reductions in serum immunoglobulins without causing broad immune suppression, supporting its advancement into Phase 1 trials [3] - Jade Biosciences focuses on developing therapies for inflammation and immunology indications in patients with autoimmune diseases [4]

Market Outlook - Victoria Greene emphasizes the importance of focusing on company fundamentals as financial earnings season begins, expecting higher volatility in the market this year [1] - Julian Emanuel maintains a bullish target of 7,750 for the S&P 500, citing continued leadership in communication services, consumer discretionary, and IT driven by AI [2] - Emanuel expresses optimism about the upcoming earnings season, noting consistently high "beat rates" and potential risks related to Fed policies [3] Company Highlights - Jade Biosciences Inc. (NASDAQ:JBIO) is positioned to lead in the autoimmune market, with a projected revenue of $926 million from its treatment candidate JADE101 by 2037 [9] - Biomea Fusion Inc. (NASDAQ:BMEA) is focusing on its primary assets icovamenib and BMF-650, with promising Phase II study results showing a sustained 1.5% reduction in HbA1c for diabetes patients [13][15]

Core Insights - Jade Biosciences, Inc. is focused on developing therapies for autoimmune diseases and has outlined its strategic priorities for 2026, including key milestones ahead of the J.P. Morgan Healthcare Conference [1][2] Key Program Updates - JADE101 is a fully human monoclonal antibody targeting APRIL, currently in Phase 1 trials, showing high binding affinity and engineered for extended half-life, aiming for patient-friendly dosing [3][4] - JADE201, an anti-BAFF-R monoclonal antibody, is set to enter first-in-human studies in rheumatoid arthritis patients in Q2 2026, with interim data expected in 2027 [5][8] - JADE301, a newly nominated development candidate, is in preclinical development with a Phase 1 trial expected to start in the first half of 2027 [6][14] Upcoming Milestones - Interim results from the JADE101 Phase 1 trial are expected in the first half of 2026, which will inform dose selection for subsequent trials [7] - The Phase 2 clinical trial for JADE101 in IgA nephropathy patients is anticipated to begin mid-2026, with preliminary data expected in 2027 [6][7] - JADE201's first-in-human study is expected to begin in Q2 2026, with interim data anticipated in 2027 [14] Financial Update - As of December 31, 2025, Jade expects to report approximately $336 million in cash and equivalents, providing operational runway into the first half of 2028 [9][10]

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 ...

Core Viewpoint - Jade Biosciences, Inc. has entered into a securities purchase agreement with BB Biotech for a private placement financing expected to yield approximately $45 million in gross proceeds before offering expenses [1][2]. Group 1: Financing Details - Jade is selling 3,214,286 shares of its common stock at a price of $14.00 per share [2]. - The private placement is anticipated to close on or about December 16, 2025, pending customary closing conditions [2]. - The net proceeds from this private placement will be allocated to research and development, general corporate expenses, and working capital needs [2]. Group 2: Securities Information - The securities involved in this transaction are not registered under the Securities Act of 1933 and cannot be reoffered or resold in the U.S. without an effective registration statement or applicable exemption [3]. - A registration rights agreement has been established, obligating the Company to file a registration statement with the SEC for the resale of the shares sold in the private placement [3]. Group 3: Company Overview - Jade Biosciences is a clinical-stage biotechnology company focused on developing therapies for autoimmune diseases [5]. - The lead candidate, JADE101, targets the cytokine APRIL and is currently in a Phase 1 clinical trial for immunoglobulin A nephropathy [5]. - The pipeline includes JADE201, an afucosylated anti-BAFF-R monoclonal antibody, and JADE-003, an undisclosed antibody discovery program, both in preclinical development [5].

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]