MannKind Jefferies Global Healthcare Conference June 5, 2025 © Copyright 2025. All rights reserved. MannKind Corporation. Cautionary Statement Statements in this presentation that are not statements of historical fact are forward- looking statements that involve risks and uncertainties. Words such as "believes", "anticipates", "plans", "expects", "intend", "will", "goal", "potential" and similar expressions are intended to identify forward-looking statements. These forward- looking statements are based upon ...

Summary of GRI Bio Conference Call Company Overview - **Company**: GRI Bio - **Focus**: Clinical stage biotech company targeting inflammatory fibrotic and autoimmune diseases through regulation of invariant natural killer T (NKT) cells [2][5] Core Program - **Lead Program**: GRI o six two one (GRI621) - **Type**: Small molecule inhibitor of type one invariant NKT cells - **Indication**: Treatment of idiopathic pulmonary fibrosis (IPF) - **Current Stage**: Phase 2a study with top line data expected in Q3 2025 [6][17] Mechanism of Action - **NKT Cells**: Critical lymphocytes involved in chronic inflammation and fibrosis - Inhibition of NKT cells shown to be therapeutic across various preclinical models of fibrosis [8][9] - Increased NKT cell activity correlates with worsening fibrotic disease, suggesting potential as a biomarker [9][12] Clinical Trial Details - **Trial Design**: - 36 patients, randomized 2:1 (GRI621 vs. placebo) - Duration: 12 weeks, with patients allowed to continue background therapy [18][19] - Primary endpoints: Safety, tolerability, pharmacokinetics, biomarkers of fibrosis, and pulmonary function tests [19][25] - **Enrollment Status**: Approximately 80% enrolled [20] Interim Results - **Recent Findings**: Positive recommendation from the Independent Data Monitoring Committee (IDMC) for continued trial [24] - **Early Data**: Indication of antifibrotic signal observed in initial 12 patients after two weeks [24] Challenges in IPF Treatment - **Current Landscape**: - Existing treatments (nantenadib and profinidone) slow lung function decline but do not improve overall survival [32] - Significant side effects limit patient compliance [32] - **Focus on Upstream Targets**: GRI Bio aims to address earlier stages in the inflammatory cascade rather than late-stage targets like TGF beta [33][34] Market Potential - **Market Size**: IPF is an orphan indication; nantenadib generated approximately $4 billion in sales last year [38] - **Competitive Landscape**: Other drugs in development face challenges, including drug-drug interactions and tolerability issues [39][40] Future Considerations - **Regulatory Pathways**: Potential for expedited approval due to existing safety data from other indications [47] - **Pipeline Opportunities**: GRI Bio is developing additional programs, including GRI o eight zero three (GRI803) targeting systemic lupus erythematosus [49][50] Conclusion - GRI Bio is positioned to address significant unmet needs in the treatment of IPF through innovative targeting of NKT cells, with ongoing clinical trials and a robust pipeline of future therapies [52]

Summary of GRI Bio Conference Call Company Overview - **Company**: GRI Bio - **Focus**: Clinical stage biotech company targeting inflammatory fibrotic and autoimmune diseases through regulation of NKT cells [2][5] Lead Program - **Product**: GRI o six two one - **Type**: Type one invariant natural killer T cell antagonist - **Indication**: Treatment of idiopathic pulmonary fibrosis (IPF) - **Current Stage**: Phase 2a study with top line data expected in Q3 2025 [6][18] Mechanism of Action - **NKT Cells**: Critical lymphocytes involved in chronic inflammation and fibrosis - **Therapeutic Approach**: Inhibiting NKT cell activity to interrupt disease progression and restore immune homeostasis [5][8] - **Biomarker Potential**: Increased NKT cells correlate with worsening fibrotic disease, suggesting their role as a useful biomarker [9][39] Clinical Trial Details - **Trial Design**: - 36 patients, 2:1 randomization (24 on GRI o six two one, 12 on placebo) - Duration: 12 weeks, with primary endpoints focusing on safety and tolerability [16][18] - **Enrollment Status**: Approximately 80% enrolled, with interim data expected in Q2 2025 [18][22] Data and Results - **Interim Analysis**: Positive recommendation from the Independent Data Monitoring Committee (IDMC) after 12 patients completed two weeks [21] - **Early Signals**: Antifibrotic signal observed in pro-collagen type III (pro C3) after two weeks [21][26] Market Context - **Market Size**: IPF is an orphan indication; Nintanadib, one of the approved drugs, generated approximately $4 billion in sales last year [35] - **Challenges**: Current treatments slow disease progression but do not improve overall survival; significant side effects limit patient compliance [29][30] Competitive Landscape - **Current Treatments**: Nintanadib and Perfinetone are the two approved drugs, both with limitations in efficacy and tolerability [35][36] - **Future Positioning**: GRI o six two one aims to address the disease earlier in the inflammatory cascade compared to existing therapies [30][31] Regulatory Considerations - **Expedited Approval**: Potential for a single registration trial due to existing safety data from other indications [43][44] Pipeline Opportunities - **Future Programs**: GRI o eight zero three targeting type two NKT cells for systemic lupus erythematosus; additional 500 compounds in the library for future development [46][47] Conclusion - GRI Bio is positioned to potentially disrupt the IPF treatment landscape with GRI o six two one, focusing on early intervention in the inflammatory process and leveraging NKT cells as biomarkers for disease progression [5][39]

Pliant Therapeutics (PLRX) Update / Briefing May 01, 2023 08:00 AM ET Speaker0 Good morning, and thank you for joining Client Therapeutics conference call. At this time, all participants are in a listen only mode. After the speakers' presentation, there will be a question and answer session. To ask a question during the session, you will need to press 11 on your telephone. You will then hear an automated message advising your hand is raised. To withdraw your question, please press 11 again. Please be advise ...