FILSPARI (sparsentan) for IgAN - FILSPARI is positioned as a foundational treatment for IgAN, targeting kidney injury by blocking ET-1 and ANG-II, with >70,000 addressable patients in the U S [9, 10, 22, 32, 64] - Clinical trials showed FILSPARI resulted in ~40% reduction in proteinuria after 110 weeks compared to irbesartan [43] - SPARTAN study showed ~70% reduction in proteinuria from baseline at week 24 in newly diagnosed patients [56] - U S commercial launch of FILSPARI outperformed benchmark launches, with ~$132 million in net sales in FY24, a ~78% growth over 2023 [61, 110] Sparsentan for FSGS - Travere plans to submit an sNDA for sparsentan in FSGS around the end of 1Q25 [11, 14] - DUPLEX study showed sparsentan resulted in a ~50% reduction in proteinuria [79] - DUPLEX study showed ~2 5x greater complete remission with sparsentan compared to irbesartan [84] - There are 15,000-30,000 potential addressable patients with FSGS in the U S [10, 70] Pegtibatinase for HCU - Pegtibatinase is a potential disease-modifying therapy for classical HCU, targeting the underlying genetic cause [14, 88, 95] - Phase 1/2 COMPOSE study showed a ~67% mean relative reduction in total homocysteine (tHcy) from baseline in the highest dose cohort [99, 106] - The company is on track to restart enrollment in the Phase 3 HARMONY Study in 2026 [14, 108]

Corporate Presentation June 2025 2 Disclaimer BioAge Labs, Inc. (the "Company") does not (nor their respective affiliates, directors, members, officers, employees or agents) make any representation or warranty, express or implied, as to, and no reliance should be placed on, the fairness, accuracy, completeness or correctness of the information and opinions contained in this Presentation or any other written or oral information made available to any interested party or its advisors and any liability therefor ...

Company Overview - Aardvark Therapeutics, Inc. is a clinical-stage biopharmaceutical company focused on developing novel small-molecule therapeutics aimed at activating innate homeostatic pathways for treating metabolic diseases, particularly Prader-Willi Syndrome (PWS) [1][4] - The lead compound, ARD-101, is currently in Phase 3 clinical development for hyperphagia associated with PWS, a rare disease characterized by insatiable hunger [4] Conference Participation - Aardvark will participate in the 2025 United in Hope Conference, engaging with the PWS community and presenting data from its Phase 2 study of ARD-101 [1][2] - The presentations will include a poster and a five-minute oral presentation titled "Reduction in Hyperphagia in the ARD-101 Phase 2 Clinical Trial Informs Phase 3 HERO Trial in PWS," highlighting ARD-101's favorable safety profile and early evidence for reduced hyperphagia [2][3] Ongoing Studies - The company is currently enrolling patients in the ongoing Phase 3 HERO study, which is informed by the data from the Phase 2 study [2][3] - Aardvark is also developing ARD-201, a fixed-dose combination of ARD-101 with a DPP-4 inhibitor, aimed at addressing limitations of currently marketed GLP-1 therapies for obesity and related conditions [4]

Core Insights - Fractyl Health's Rejuva platform shows promise as a one-time, durable therapy for obesity and type 2 diabetes (T2D), demonstrating a favorable toxicity profile in preclinical studies [1][2][4] - The mechanism of action for Rejuva is distinct from systemic GLP-1 receptor agonists, allowing for nutrient-responsive secretion that activates only under metabolic stress [2][3] - Preliminary clinical data for RJVA-001, the first clinical candidate from the Rejuva platform, is expected in 2026, pending regulatory authorization [5][11] Key Findings - A single dose of Rejuva in a study with mice resulted in a 20% reduction in body weight and a 38% decrease in blood glucose levels by day 21, effects maintained despite continued high-fat diet exposure [7] - Rejuva-treated lean animals showed no weight gain or hyperglycemia when switched to a high-fat diet, maintaining baseline body weight and showing an 8% reduction in blood glucose [7] - The treatment was well-tolerated with no signs of toxicity or excessive weight loss in healthy animals, reinforcing the self-limiting nature of Rejuva's mechanism [7] Momentum Toward the Clinic - Fractyl Health has completed key in vivo studies for RJVA-001 and anticipates dosing the first patients in 2026, aiming for a first-in-class gene therapy that reprograms the pancreas for natural metabolic control [5][11] Scientific Validation - The study was conducted by a team from Fractyl Health and the University of Michigan, including experts in metabolic diseases, highlighting the scientific momentum behind Rejuva's approach [6][8]

Core Insights - Fractyl Health, Inc. is focused on innovative metabolic therapeutics aimed at addressing the root causes of obesity and type 2 diabetes (T2D) [1][3] - The company will present new preclinical data from its Rejuva Smart GLP-1 pancreatic gene therapy platform at the American Diabetes Association's 85th Scientific Sessions [1][2] Company Overview - Fractyl Health is dedicated to transforming the treatment of metabolic diseases from chronic management to durable, disease-modifying therapies [3] - The company is based in Burlington, Massachusetts, and aims to tackle the increasing prevalence of obesity and T2D, which are significant contributors to morbidity and mortality in the 21st century [3] Rejuva Platform - The Rejuva platform is focused on developing next-generation adeno-associated virus (AAV)-based gene therapies specifically for obesity and T2D [4] - Currently in preclinical development, the Rejuva platform utilizes advanced delivery systems and proprietary screening methods to identify gene therapy candidates targeting the pancreas [4] - The goal of the Rejuva program is to provide novel therapies that address the underlying causes of metabolic diseases [4]

Company Overview - Veru Inc. is a late clinical stage biopharmaceutical company focused on developing innovative medicines for cardiometabolic and inflammatory diseases [2] - The company's drug development program includes two late-stage novel small molecules: enobosarm and sabizabulin [2] Enobosarm Development - Enobosarm is a selective androgen receptor modulator (SARM) aimed at enhancing weight reduction by making GLP-1 RA drugs more tissue selective for fat loss while preserving lean mass [2] - Positive topline and safety results were announced from the Phase 2b QUALITY clinical study, which involved 168 older patients (≥60 years) receiving semaglutide for chronic weight management [3] - The Phase 2b extension study will evaluate whether enobosarm can prevent fat regain after stopping GLP-1 RA treatment, with topline results expected in Q2 2025 [3] Sabizabulin Development - Sabizabulin is being explored as a treatment for inflammation in atherosclerotic cardiovascular disease, addressing a significant unmet medical need [4][5] - The drug has shown broad anti-inflammatory activity in previous clinical studies, with a safety database consisting of 266 dosed patients [4][5] - The company plans to submit a new IND for sabizabulin's proposed indication by the first half of 2026 [6] Market Opportunity - The decision to explore sabizabulin for atherosclerotic cardiovascular disease is based on the large global market opportunity and the high probability of success due to its mechanism of action being similar to colchicine [5] - The company aims to assess the progression of coronary atherosclerosis using coronary CT angiography imaging as a primary endpoint in a small Phase 2 proof of concept study [5]

Core Insights - Metsera, Inc. is presenting its portfolio of ultra-long acting therapies for obesity and metabolic diseases at the 85th Scientific Sessions of the American Diabetes Association (ADA) [1][2] - The lead program, MET-097i, is a fully biased, monthly, ultra-long acting GLP-1 receptor agonist, with clinical data from its Phase 1/2 trial being showcased [2][4] - Additional presentations will cover preclinical data for MET-233i, an ultra-long acting amylin analog, and other differentiated portfolio assets [1][3] Presentation Highlights - MET-097i is highlighted as a potent and ultra-long-acting GLP-1 receptor agonist, with clinical data focusing on body weight change and tolerability after twelve weekly doses and a single monthly dose [2][4] - MET-233i will present preclinical data, including pharmacokinetic details and body weight change data [3][7] Presentation Details - Clinical presentations for MET-097i will occur on June 22, featuring two key sessions led by Metsera's executives [4][5][6] - Preclinical data for MET-233i will also be presented on the same date, showcasing its potential as an ultra-long-acting amylin receptor agonist [7] Pipeline Programs - Metsera is exploring therapeutic combinations, including ultra-long-acting GLP-1, GIP, glucagon, and amylin peptide analogs, which have shown promising results in inducing weight loss in preclinical models [8] - Health economics research will also be presented, highlighting the suboptimal titration to maintenance doses of GLP-1 receptor agonists for overweight and obesity patients [9] Company Overview - Metsera is a clinical-stage biopharmaceutical company founded in 2022, focused on developing next-generation medicines for obesity and metabolic diseases [10]

Core Insights - Nxera Pharma has achieved a significant development milestone in its collaboration with Eli Lilly, which is expected to result in a milestone payment in Q3 of the fiscal year ending December 2025 [1][2] - The collaboration, initiated in 2022, leverages Nxera's GPCR-focused drug design capabilities alongside Lilly's expertise in development and commercialization [2] - Nxera is eligible for up to US$694 million in development and commercial milestones, in addition to tiered royalties on global sales [3] Company Overview - Nxera Pharma is a biopharma company focused on developing specialty medicines for unmet medical needs, particularly in Japan and the broader APAC region [5] - The company has an extensive pipeline of over 30 active programs targeting areas such as neurology, metabolic diseases, and immunology, utilizing its proprietary NxWave™ discovery platform [6] - Nxera employs approximately 400 people across key locations including Tokyo, Osaka, London, Cambridge, Basel, and Seoul [7]

Company Overview - Akero Therapeutics, Inc. is a clinical-stage company focused on developing transformational treatments for serious metabolic diseases with high unmet medical needs, including metabolic dysfunction-associated steatohepatitis (MASH) [3] Clinical Development - The lead product candidate, efruxifermin (EFX), is currently being evaluated in three ongoing Phase 3 clinical studies: SYNCHRONY Histology, SYNCHRONY Outcomes, and SYNCHRONY Real-World, targeting different patient populations affected by MASH [3] - The Phase 3 SYNCHRONY program builds on the results of two Phase 2b clinical trials: the HARMONY study for pre-cirrhotic MASH and the SYMMETRY study for compensated cirrhosis due to MASH [3] Upcoming Events - Management will present at the Jefferies Global Healthcare Conference on June 4, 2025, at 8:45 a.m. P.T. [1] - A live webcast of the presentation will be available on the company's investor relations website, with an archived replay to follow [2]

Scholar Rock Holding (SRRK) Q1 2025 Earnings Call May 14, 2025 08:15 AM ET Company Participants Rushmie Nofsinger - Vice President of Corporate Affairs & Investor RelationsDavid Hallal - CEO & ChairmanAkshay Vaishnaw - President, R&DKeith Woods - COOVikas Sinha - CFOMichael Yee - Managing DirectorDavid Nierengarten - Managing Director - Equity ResearchGary Nachman - Managing Director - Equity ResearchMalcolm Hoffman - Senior BioPharma Equity Research AssociateAndres Maldonado - Vice President Conference Cal ...