Jade Biosciences (NasdaqCM:JBIO) 2025 Conference November 17, 2025 10:30 AM ET Company ParticipantsAndrew King - Chief Scientific OfficerTom Frohlich - CEOConference Call ParticipantsAkash Tewari - Farm and Biotech AnalystAkash TewariAkash Tewari. I am a Farm and Biotech Analyst here at Jefferies. Day one of our London Healthcare Conference, and I got the pleasure of hosting the Jade Management Team. Why don't I hand it off to you for some intro remarks, and then we'll get started with Q&A?Tom FrohlichAbsol ...

Presented favorable preclinical safety data for JADE101 and a translational analysis of APRIL mediated biomarker responses at the American Society of Nephrology Kidney Week 2025, reinforcing its potential as a best-in-class selective anti-APRIL monoclonal antibody for IgA nephropathy Initiated Phase 1 healthy volunteer study of JADE101; interim, biomarker-rich data expected in the first half of 2026 are anticipated to define dose and dose interval selection for patient trials Unveiled JADE201, a potentially ...

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]

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, Inc. is focused on developing advanced therapies for autoimmune diseases, with its lead candidate, JADE101, targeting immunoglobulin A nephropathy [3] - The company will participate in several upcoming conferences, including one-on-one investor meetings [1][6] Company Overview - Jade Biosciences is dedicated to addressing unmet needs in autoimmune diseases, with a pipeline that includes JADE101 and a second candidate, JADE201, along with an undisclosed antibody discovery program, JADE-003 [3] - The company was established based on assets licensed from Paragon Therapeutics, an antibody discovery engine [3] Upcoming Events - Jade will host a fireside chat at the Cantor Global Healthcare Conference on September 3, 2025, at 3:20 p.m. ET [6] - The company will also participate in the Stifel Virtual Immunology and Inflammation Forum on September 16, 2025, at 1:00 p.m. ET [6] - Additionally, Jade will be part of the 11th Annual World Medical Innovation Forum on September 16, 2025, at 4:40 p.m. ET [6]

Core Insights - Jade Biosciences, Inc. reported a productive second quarter, closing a reverse merger and significant financing while advancing its pipeline for autoimmune disease therapies [2][5] - The company presented preclinical data for its lead candidate, JADE101, which shows potential as a best-in-class therapy for IgA nephropathy [5][6] - Jade is transitioning into a clinical-stage company, with plans for a Phase 1 study of JADE101 expected to begin in Q3 2025 [5][6] Financial Results - As of June 30, 2025, Jade had cash and cash equivalents of $220.9 million, which is expected to support operations through 2027 [10][13] - Research and Development (R&D) expenses for Q2 2025 totaled $22.5 million, while General and Administrative (G&A) expenses were $5.2 million [10][14] - The net loss for Q2 2025 was $32.1 million, including non-cash stock-based compensation of $4.0 million [10][15] Pipeline and Corporate Updates - JADE101 is an anti-APRIL monoclonal antibody targeting IgA nephropathy, with a Phase 1 study anticipated to start in Q3 2025 [3][5] - JADE201, another development candidate, is on track to enter clinical trials in the first half of 2026 [6][8] - Brad Dahms has been appointed as Chief Financial Officer, bringing extensive biopharmaceutical and investment banking experience [4]