Stevanato Group (STVN) 2025 Conference June 05, 2025 10:30 AM ET Speaker0 Jeff there we go. Hi. Good morning. Dave Windley with Jefferies Healthcare Equity Research. Appreciate your attendance and and interest in our conference twenty twenty five. We are on kind of the homestretch here on Thursday. Our presenting company for this session is Stevanato Group. Here to present for them is the company's CEO, Franco Sveinato. So he has just a few slides and is going to give some prepared remarks to kick off and t ...

Core Insights - Eli Lilly has experienced significant revenue growth driven by its weight loss drug portfolio, particularly Mounjaro and Zepbound, which have become blockbusters generating over $11 billion and $4.9 billion in sales respectively [10] - The company is well-positioned in the weight loss market, competing with Novo Nordisk, and has plans to advance its oral weight loss candidate, orforglipron, which could provide a competitive edge [11] Company Overview - Eli Lilly offers a diverse range of medicines, including cancer and immunology drugs, but its weight loss drugs have recently become a standout category [1][2] - The company's weight loss drugs are classified as dual GIP and GLP-1 receptor agonists, which help control blood sugar levels and appetite [5] Market Dynamics - The demand for weight loss drugs has been robust, leading to a significant market presence for both Eli Lilly and Novo Nordisk, with Lilly quickly gaining market share after launching Mounjaro in 2022 and Zepbound in 2023 [6] - Despite a recent reduction in Goldman Sachs' forecast for global sales of anti-obesity medicines to $95 billion by 2030, this still represents a 239% increase from the current $28 billion market [8][9] Financial Performance - Eli Lilly's total sales growth has been impressive, with a 32% increase in the full year and a 45% increase in the most recent quarter [10] - The company's shares are currently trading at 34 times forward earnings estimates, comparable to leading tech companies, indicating strong growth potential [12][14] Competitive Advantage - Lilly's potential oral weight loss drug, orforglipron, could provide a significant advantage over Novo Nordisk's oral semaglutide, as it does not involve strict food and water guidelines [11] - The company combines the growth potential of a tech stock with the stability and dividend growth typical of pharmaceutical companies, making it an attractive investment option [15][16]

Core Viewpoint - Innovent Biologics has presented promising clinical data for IBI354, a HER2 monoclonal antibody-camptothecin derivative conjugate, at the 2025 ASCO Annual Meeting, highlighting its potential in treating advanced solid tumors, particularly in ovarian and breast cancer [1][2]. Group 1: Clinical Data and Efficacy - IBI354 has shown promising anti-tumor efficacy and favorable safety profiles across multiple solid tumors, indicating its potential as a new generation of ADC therapies characterized by high potency and low toxicity [2][5]. - The Phase 1/2 clinical study enrolled 368 participants with advanced solid tumors, with a median follow-up duration of 11.5 months and a median treatment duration of 27.0 weeks [3]. - In the ovarian cancer cohort, IBI354 achieved an objective response rate (ORR) of 55.0% and a disease control rate (DCR) of 90.0% at a dose of 12mg/kg Q3W, with a median progression-free survival (PFS) of 7.1 months [6][7]. Group 2: Safety Profile - IBI354 demonstrated an excellent safety profile, with a low incidence of treatment-related adverse events (TRAEs) and no dose-limiting toxicities (DLTs) observed at escalated doses [4][7]. - The most common TRAEs included anemia, nausea, and decreased white blood cell count, with only 1.9% of patients experiencing interstitial lung disease [7]. Group 3: Future Development and Strategic Positioning - The Phase 3 study of IBI354 in platinum-resistant ovarian cancer has been initiated, indicating the company's commitment to further validating the long-term benefits of this treatment [8]. - Innovent is advancing its strategic layout in the ADC field, with plans for additional clinical studies and investments in next-generation ADC molecules to address unmet clinical needs [8][10].

Group 1 - The article discusses the importance of staying updated on stocks in the biotech, pharma, and healthcare industries, particularly focusing on glucagon-like peptide receptor agonists (GLP-RA or GLP-1s) [1] - It highlights the services provided by the Haggerston BioHealth investing group, which includes catalysts for investment decisions, sales forecasts, and financial analyses for major pharmaceutical companies [1] - The author, Edmund Ingham, has extensive experience in biotech consulting and has produced detailed reports on over 1,000 companies in the sector [1]

Core Insights - Processa Pharmaceuticals, Inc. announced the acceptance of three abstracts for the 2025 ASCO Annual Meeting, showcasing its Next Generation Cancer (NGC) drug candidates, including PCS6422 and PCS11T [1][6] Abstract Summaries - The first abstract discusses the safety and efficacy of Eniluracil + Capecitabine (6422 + Cap) in a Phase 1b trial, highlighting its improved safety profile and anti-tumor activity compared to standard capecitabine [3][4] - The second abstract outlines a Project Optimus-aligned approach for the preclinical study of PCS11T, a tumor-targeted pro-drug of SN-38, aimed at increasing drug concentration in tumors while minimizing systemic toxicity [4][5] - The third abstract presents an overview of an ongoing Phase 2 adaptive design trial evaluating the safety and efficacy of PCS6422 combined with capecitabine in patients with advanced or metastatic breast cancer, focusing on optimal dosing regimens and personalized medicine [9]

Core Viewpoint - Cocrystal Pharma, Inc. has announced that its novel influenza PB2 inhibitor CC-42344 demonstrates strong antiviral activity against the highly pathogenic H5N1 avian influenza strain, indicating potential for treating both pandemic and seasonal influenza infections [1][3][4] Company Summary - Cocrystal Pharma is a clinical-stage biotechnology company focused on discovering and developing antiviral therapeutics targeting the replication processes of various viruses, including influenza and coronaviruses [7] - The company employs structure-based technologies and expertise to create first- and best-in-class antiviral drugs [7] Product Development - CC-42344 is an investigational drug candidate that binds to a conserved active site of the PB2 protein, inhibiting viral replication [2][3] - The virology study showed that CC-42344 has an EC50 of 0.003 µM against the H5N1 strain, making it approximately 1,000-fold more potent than Tamiflu, which has an EC50 of 2.69 µM [3][8] - Initial data from the development of CC-42344 indicates a favorable safety and tolerability profile [3][4] Market Potential - The influenza market is valued in the multibillion-dollar range, with influenza responsible for an estimated $11.2 billion in direct and indirect costs annually in the U.S. [4] - On average, about 8% of the U.S. population contracts influenza each season, highlighting the significant public health concern [4] Industry Context - The emergence of highly pathogenic avian influenza strains poses a risk of adaptation for human-to-human transmission, raising concerns about potential influenza pandemics [2][5] - Recent studies indicate extremely low population immunity to H5N1 viruses in the U.S., suggesting a vulnerability to outbreaks [6]

Group 1 - Vanda Pharmaceuticals Inc. will participate in the ASCP Annual Meeting from May 27 to May 30, 2025, presenting pharmacokinetic results of Milsaperidone and Iloperidone [1] - The presentation will include a poster titled "Pharmacokinetic Results of Single-Dose and Multiple-Dose Bioequivalence Studies of Milsaperidone and Iloperidone Immediate-Release Oral Tablets" [1] Group 2 - Bysanti™ is a new atypical antipsychotic drug that, if approved, could be available for sale in the US in 2026 [2] - Bysanti™ is expected to interact with various neurotransmitter receptors, including alpha-adrenergic, serotonin, and dopamine receptors [2] - Patent exclusivity for Bysanti™ could extend into the 2040s [2] Group 3 - Vanda Pharmaceuticals Inc. is focused on developing and commercializing innovative therapies to meet high unmet medical needs [3]

Only half of health insurer Cigna's clients currently cover the popular GLP-1 weight loss drugs Wegovy and Zepbound because of their high costs. But the company's pharmacy benefits unit Evernorth has reached a deal with drug makers Ely Lilly and Novo Nordisk which it said will bring prices down for employers and their workers."This solution is really focused towards clients that aren't covering it today, and what it allows us to do is one, to bring it on at a reduced price for the plan sponsor, but also cap ...

Summary of Werewolf Therapeutics Conference Call Company Overview - Werewolf Therapeutics is a clinical stage biopharmaceutical company focused on developing conditionally activated biologics for cancer and other serious diseases. The company has engineered a pipeline of cytokine prodrugs, referred to as endokines, to address therapeutic index challenges associated with potent biologics [2][3] Core Programs - The lead endokine programs include: - WTX-124 (an interleukin-2 endokine) - WTX-330 (an interleukin-12 endokine) - The company has also developed T cell engagers called inducers, designed to address therapeutic index challenges of T cell engagers [3][19] Clinical Data and Efficacy - WTX-124 has completed dose escalation for both monotherapy and combination therapy with pembrolizumab, with a determined dose of 18 mg delivered IV every two weeks [5][6] - Expansion arms are open for indications including: - Cutaneous melanoma - Renal cell carcinoma - Cutaneous squamous cell carcinoma, where a patient achieved a complete response after failing standard treatment [6][7] - The company aims for an overall response rate above 20% for monotherapy and higher for combination therapy, with enrollment progressing well [11][12] Safety Profile - The safety profile of WTX-124 has shown no hallmark toxicities associated with high-dose IL-2, allowing for outpatient delivery to a broad patient population [9][10] Regulatory Pathway - The company plans to present data to the FDA in the coming quarters, seeking insights on both monotherapy and combination data for potential registration [13][14] Future Expectations - The company anticipates presenting updated interim data in Q4 2025, with a focus on both efficacy and safety metrics [9][22] - For WTX-330, the company has completed a first-in-human trial, showing a good safety profile and antitumor activity, with plans for further studies [16][17] Inducers Platform - The inducers platform aims to mask immune cell engagement to reduce cytokine release syndrome, enhancing the therapeutic index of T cell engagers [19][20] - The company plans to announce a development candidate for the inducers platform imminently [22] Conclusion - Werewolf Therapeutics is positioned for significant developments in the coming months, with a robust pipeline and promising clinical data that could lead to regulatory advancements and potential market opportunities [24][25]

Core Insights - Thiogenesis Therapeutics has initiated a Phase 2 clinical trial for TTI-0102, targeting the treatment of MELAS, an inherited mitochondrial disease [1][3] - The trial aims to assess the safety, tolerability, efficacy, and pharmacokinetics of TTI-0102 over a 6-month period, involving 12 patients [2][3] - TTI-0102 is designed to increase intracellular antioxidants and amino acids, addressing deficiencies in MELAS patients [3][8] Company Overview - Thiogenesis Therapeutics is a clinical-stage biotechnology company based in San Diego, focusing on developing disulfides that enhance intracellular antioxidant production [1][10] - The company is publicly traded on the TSX Venture Exchange and OTCQX, with a focus on treating serious pediatric diseases with unmet medical needs [10] Clinical Trial Details - The Phase 2 trial is a multi-country, multi-center study conducted in the Netherlands and France, with a randomized, double-blind, placebo-controlled design [2] - A total of 12 patients will be enrolled, with 8 receiving TTI-0102 and 4 receiving a placebo, followed by an interim analysis after 3 months [2] Disease Background - MELAS is characterized by symptoms such as seizures, muscle weakness, and fatigue, often presenting before the age of 20, and is caused by mitochondrial DNA mutations [4] - The disease affects approximately 4.1 per 100,000 of the population, making it one of the most prevalent inherited mitochondrial disorders [4] Product Information - TTI-0102 is an asymmetric disulfide and prodrug that acts as a precursor to cysteamine, aimed at restoring mitochondrial function by increasing levels of glutathione and taurine [8] - The prodrug formulation addresses limitations of first-generation thiol-based drugs, including short half-life and adverse side effects [8][9]