Summary of Climb Bio's Conference Call Company Overview - **Company**: Climb Bio - **Focus**: Autoimmune diseases with two antibodies in clinical development Key Points Upcoming Milestones - Climb Bio has five clinical data readouts scheduled for this year - Monoclonal antibody targeting CD19: - Data on subcutaneous (subQ) formulation in healthy volunteers expected in the first half of the year - Initial data from Phase 1b studies in Immune Thrombocytopenic Purpura (ITP) and Systemic Lupus Erythematosus (SLE) in the second half - Initial data from Phase 2 study in Primary Membranous Nephropathy (PMN) also expected in the second half - Second antibody, an APRIL-only antibody for IgA nephropathy, will have data available mid-year [2][3][4] Competitive Landscape - UPLIZNA is currently the only approved CD19 antibody, focusing on rare neuro diseases - Climb Bio's CD19 antibody is believed to have greater affinity and a subQ formulation option, which UPLIZNA lacks [5][7][11] PMN Indication - No approved therapies currently exist for PMN; standard care includes off-label use of rituximab - Rituximab achieves complete renal remission in only 10% of patients after one year and 35% after two years - Climb Bio's Phase 1b study showed a 60% complete remission rate and 100% serological remission in PLA2R antibody-positive patients [14][15][32] Market Opportunity - Approximately 70,000 patients in the U.S. have PMN, with two-thirds requiring therapeutic intervention - Regulatory strategy involves one Phase 3 study with around 150 patients, focusing on proteinuria as the primary endpoint [32][34] ITP and SLE Indications - ITP has a strong rationale for CD19 targeting, with only 20% of refractory patients achieving a durable platelet response - SLE is viewed as a more complex indication, requiring larger pivotal trials; Climb Bio is conducting a parallel study in China for lupus nephritis patients [39][40][41] APRIL Antibody Development - Climb Bio's APRIL-only antibody (CLYM116) features a unique sweeper mechanism, allowing for high-affinity binding and potential for longer half-life - Early studies indicate a two- to threefold longer half-life compared to existing therapies, with better activity in IgA suppression [48][56][60] Financial Position - Climb Bio reported $176 million in cash at the end of Q3, with a runway extending into 2028, covering all planned readouts for the year [93][95] Future Indications - Climb Bio is exploring additional indications for the APRIL antibody, including Sjögren's syndrome, to maximize asset potential [90][91] Conclusion - Climb Bio is positioned to address significant unmet needs in autoimmune diseases with promising clinical data and a strong financial foundation, paving the way for potential market success in the coming years [2][93][95]

Core Thesis - Vera Therapeutics, Inc. is positioned as a promising investment opportunity due to its focus on atacicept, a biologic therapy targeting IgA nephropathy, a significant cause of chronic kidney disease [2][4]. Company Overview - Vera Therapeutics is a clinical-stage biotechnology company dedicated to developing therapies for autoimmune diseases, primarily through its lead asset, atacicept [2]. - Atacicept aims to address the root cause of IgA nephropathy by blocking the production of pathogenic IgA antibodies, moving beyond traditional symptom management approaches [3]. Market Opportunity - The total addressable market for IgA nephropathy is estimated at $10 billion in the U.S., which could double when including Europe and Japan [4]. - Approximately 100,000 patients in the U.S. are affected by IgA nephropathy, with around half requiring advanced treatment options [4]. Revenue Potential - Vera anticipates commercial shipments of atacicept to begin in 2026, with expectations of capturing a 15%–25% market share, leading to peak annual revenues of $1.5–$2.5 billion [4]. - The drug is positioned to become a blockbuster by the end of the decade, supported by strong clinical data [4][5]. Clinical Data and Regulatory Pathway - Recent Phase 3 clinical trial results published in the New England Journal of Medicine indicate that atacicept is both safe and effective, bolstering its commercial prospects [5]. - Vera has submitted a Biologics License Application under the FDA's Accelerated Approval Program, aiming for potential commercialization in mid-2026 [5]. Competitive Landscape - Despite positive developments, Vera's stock has remained stable, likely due to investor caution regarding a competing therapy's regulatory decision [6]. - The large and underserved market for IgA nephropathy suggests that multiple therapies can coexist, potentially validating the market opportunity [6]. Valuation and Investment Appeal - Vera is considered undervalued at approximately 5 times its potential peak revenues, presenting a compelling risk-reward profile with clear upside catalysts [6].

Core Insights - Vera Therapeutics has appointed Matt Skelton as Chief Commercial Officer to lead the commercial launch of atacicept for IgA nephropathy [1][2] - Atacicept is a promising investigational treatment that targets B-cell activation and has shown significant clinical efficacy in trials [3][4][6] Company Overview - Vera Therapeutics is a late clinical-stage biotechnology company focused on developing treatments for serious immunological diseases [10] - The company's lead product candidate, atacicept, is designed to block B-cell Activating Factor (BAFF) and A PRoliferation-Inducing Ligand (APRIL), which are involved in autoimmune diseases [10] Leadership Appointment - Matt Skelton brings extensive experience in global commercialization, having previously scaled Seagen's commercial organization from one product to four approved products [2][10] - His leadership is expected to be critical in transitioning Vera Therapeutics into a commercial-stage company [2] Atacicept Clinical Program - The ORIGIN Phase 2b clinical trial of atacicept met its primary and key secondary endpoints, showing significant reductions in proteinuria and stabilization of eGFR [4] - The ongoing ORIGIN 3 Phase 3 trial has also met its primary endpoint with a statistically significant reduction in proteinuria at week 36 [5] Regulatory Status - Atacicept has received Breakthrough Therapy Designation from the FDA for IgA nephropathy, indicating its potential to significantly improve treatment outcomes [6] - The Biologics License Application (BLA) for atacicept has received Priority Review designation, with a target action date set for July 7, 2026 [7] Future Studies - The ORIGIN Extend study allows participants to access atacicept until its commercial availability and collects long-term safety and efficacy data [8] - Atacicept is also being evaluated in other autoimmune kidney diseases, expanding its potential therapeutic applications [8][10]

Company Overview - Vera Therapeutics was founded in San Francisco in 2016 and in-licensed atacicept in 2020 [3] - The company aims to lead a paradigm shift in modulating the immune system to alleviate disease burdens [1] Product Information - Atacicept is a first-in-class dual BAFF April inhibitor, designed to control autoimmune disease activity while minimizing immune suppression challenges [3] - Positive Phase III results were reported last year, leading to the submission of a Biologics License Application (BLA) to the U.S. FDA [3] - The FDA has awarded priority review for atacicept, with a Prescription Drug User Fee Act (PDUFA) date set for July 7, 2026 [3]

Summary of Vera Therapeutics FY Conference Call Company Overview - **Company**: Vera Therapeutics (NasdaqGM:VERA) - **Founded**: 2016 in San Francisco - **Lead Product**: Atacicept, a first-in-class dual BAFF/APRIL inhibitor - **Financial Position**: Pro forma cash of $779 million with 71.3 million shares outstanding [4][5] Industry Context - **Primary Indication**: IgA nephropathy (IgAN), the most common primary glomerular disease worldwide, with an incidence of 2.5 per 100,000 people [6] - **Market Size**: Estimated 160,000 diagnosed IgAN patients in the U.S., with half in the highest-risk category [14] - **Competitive Landscape**: Five new drugs approved for IgAN in the past five years, indicating a growing market with premium pricing [16] Key Product Insights - **Atacicept Mechanism**: Targets BAFF and APRIL to modulate B-cell function, potentially avoiding immune suppression challenges [3][5] - **Clinical Trials**: - Phase III trial met primary endpoint with a 42% placebo-adjusted reduction in proteinuria at 36 weeks [11] - Secondary endpoints showed consistent results with phase II data [11] - Ongoing trials include PIONEER, studying Atacicept in moderate and low-risk patients [15] Regulatory and Commercialization Plans - **BLA Submission**: Submitted to the U.S. FDA with priority review status; PDUFA date set for July 7, 2026 [3][18] - **Commercial Launch**: Expected in July 2026, with a focus on educating nephrologists about Atacicept [13][21] - **Sales Force**: Hiring 82 sales representatives to target over half of the 11,000 nephrologists in the U.S. [23] Clinical Efficacy and Safety - **Efficacy Measures**: Aims to stabilize eGFR, reduce proteinuria, and resolve kidney inflammation [9][12] - **Safety Profile**: Atacicept showed a low rate of serious adverse events (0.5%) and was well tolerated [12] Future Opportunities - **Expansion Potential**: Atacicept has therapeutic potential in other autoimmune diseases, with an estimated addressable market of 1.2 million patients in the U.S. [17][18] - **Pipeline Development**: Ongoing studies for additional indications and formulations, including a monthly dosing option [29][31] Conclusion - **Transformative Year Ahead**: Vera Therapeutics is positioned for significant growth in 2026 with the anticipated launch of Atacicept and ongoing clinical trials [18][34]

Core Insights - Vera Therapeutics is a late clinical-stage biotechnology company focused on developing transformative treatments for serious immunologic diseases [3] Company Overview - Vera Therapeutics' mission is to advance treatments that target the source of disease to change the standard of care for patients [3] - The lead product candidate is atacicept, a fusion protein administered at home as a subcutaneous weekly injection, which blocks B-cell Activating Factor (BAFF) and A PRoliferation-Inducing Ligand (APRIL) [3] - Atacicept is aimed at treating autoimmune diseases such as immunoglobulin A nephropathy (IgAN) and lupus nephritis, with ongoing evaluations for additional diseases [3] - The company holds an exclusive license agreement with Stanford University for a next-generation fusion protein, VT-109, targeting BAFF and APRIL, with potential across B-cell-mediated diseases [3] - Vera Therapeutics is also developing MAU868, a monoclonal antibody designed to neutralize BK virus infections, particularly in kidney transplant recipients [3] - The company retains all global developmental and commercial rights to atacicept, VT-109, and MAU868 [3] Event Participation - The management team will present at the 44th Annual J.P. Morgan Healthcare Conference in San Francisco from January 12-15, 2026, and will participate in one-on-one investor meetings [1] - The presentation is scheduled for January 13, 2026, at 2:15 PM PST, with a webcast available [2]

Core Viewpoint - Vera Therapeutics is poised to commercialize its investigational drug atacicept, following the acceptance of its biologics license application (BLA) for priority review by the FDA, which has led to a positive market response with a nearly 5% increase in share price [1][2]. Group 1: Regulatory Submission and Drug Details - The FDA has accepted Vera's BLA for atacicept, targeting IgA nephropathy (IgAN), also known as Berger's disease [2]. - The BLA has a target action date of July 7, 2026, and if approved, the drug could be available in pharmacies shortly thereafter [3]. - The application is supported by a Phase 3 study that successfully met its primary endpoint of reducing proteinuria [3]. Group 2: Market Context and Competition - Vera's CEO emphasized the importance of the FDA's priority review designation, highlighting the need for new therapies in the IgAN treatment landscape [5]. - The success of atacicept will be influenced by its pricing strategy, especially in light of competition from Otsuka Pharmaceutical's similar medication, Voyxact, which is priced at $30,000 per monthly treatment [5].

Core Viewpoint - Vera Therapeutics Inc. has received FDA acceptance for the Priority Review of its atacicept Biologics License Application (BLA) aimed at treating immunoglobulin A nephropathy (IgAN), an autoimmune kidney disease that can lead to severe complications [1][3]. Group 1: Product Development - Atacicept is designed as a self-administered subcutaneous injection to be taken once a week, targeting B-cell Activating Factor (BAFF) and A Proliferation-Inducing Ligand (APRIL), which are cytokines involved in the production of autoantibodies related to IgAN and other autoimmune kidney diseases [2]. - The BLA was submitted under the Accelerated Approval Program, with a Prescription Drug User Fee Act (PDUFA) target action date set for July 7, 2026 [3]. Group 2: Clinical Data - The BLA submission is supported by interim analysis data from the ORIGIN 3 trial, which showed a 46% reduction in proteinuria at week 36 for participants treated with atacicept, compared to a statistically significant 42% reduction versus placebo [4]. Group 3: Market Potential - Analysts project that atacicept could tap into a multi-billion-dollar market, with a peak sales forecast of $3 billion by 2037, contingent on further clinical validation [5]. - The competitive landscape includes Novartis A/S's Fabhalta (iptacopan), which has shown significant efficacy in slowing IgAN progression in a Phase 3 study [6]. Group 4: Stock Performance - Following the FDA news, Vera Therapeutics shares increased by 4.49%, reaching $48.61 [7].

Core Viewpoint - Vera Therapeutics announced that the Biologics License Application (BLA) for atacicept, aimed at treating adults with immunoglobulin A nephropathy (IgAN), has been accepted for Priority Review by the FDA, with a target action date of July 7, 2026. If approved, atacicept will provide a self-administered, once-weekly subcutaneous injection for patients [1][7]. Company Overview - Vera Therapeutics is a late clinical-stage biotechnology company focused on developing transformative treatments for serious immunological diseases, with atacicept as its lead product candidate [11]. Product Details - Atacicept is an investigational recombinant fusion protein that targets B-cell Activating Factor (BAFF) and A Proliferation-Inducing Ligand (APRIL), which are cytokines involved in the production of autoantibodies associated with IgAN and other autoimmune kidney diseases [4][11]. - The drug is designed for at-home self-administration, allowing patients to receive treatment conveniently [1][11]. Clinical Trial Results - The BLA submission for atacicept is supported by data from the ORIGIN 3 trial, which demonstrated a 46% reduction in proteinuria from baseline and a statistically significant 42% reduction compared to placebo at week 36 [2][5]. - The ORIGIN Phase 2b clinical trial met its primary and key secondary endpoints, showing significant proteinuria reductions and stabilization of estimated glomerular filtration rate (eGFR) compared to placebo [5][6]. Regulatory Status - Atacicept has received FDA Breakthrough Therapy Designation for IgAN, indicating its potential to provide substantial improvement over existing therapies [9][7]. - The FDA's Priority Review designation highlights the urgent need for new therapies in the IgAN treatment landscape [2][7]. Future Prospects - The ongoing ORIGIN 3 trial involves 431 adults with IgAN and aims to evaluate the long-term effects of atacicept on kidney function, with results expected in 2027 [6][8]. - Vera Therapeutics is also exploring atacicept's efficacy in other autoimmune diseases, expanding its potential market [10][11].

Core Viewpoint - Vera Therapeutics' stock experienced a significant increase of nearly 13% following a bullish research note from analyst Ryan Deschner, who maintains a strong buy recommendation and a price target of $73 per share [1][2]. Group 1: Analyst Insights - Ryan Deschner of Raymond James reiterated a strong buy recommendation for Vera Therapeutics, maintaining a price target of $73 per share [2]. - Deschner's analysis focused on atacicept, a leading pipeline drug for treating IgA nephropathy, highlighting its potential competitive pricing advantage over a newly FDA-approved competitor [3]. Group 2: Competitive Landscape - Otsuka Pharmaceutical's Voyxact, a competitor recently approved by the FDA, is priced at $30,000 for a treatment every four weeks, which is approximately double the expected cost of atacicept [3]. - If Deschner's pricing assumption for atacicept is accurate, Vera Therapeutics could have a significant market advantage if the drug successfully completes clinical trials and receives regulatory approval [6]. Group 3: Market Data - Vera Therapeutics' current stock price is $37.25, with a market capitalization of $2 billion [4]. - The stock has shown a day's range between $32.92 and $39.81, with a trading volume of 4.4 million shares [5].