Roche (ROG) Status Update summary

Pipeline and Portfolio Strategy

• Focus on building a comprehensive CBRM (Cardiovascular, Renal, Metabolism) franchise, with obesity as a central pillar due to its role in multiple comorbidities and rising global prevalence; over 3 billion people expected to be overweight or obese by 2035.

• Key assets include CT-388 (injectable dual GLP-1/GIP RA), CT-996 (oral GLP-1 RA), and CT-868 (injectable dual GLP-1/GIP RA for T1D adjunct therapy), with additional early-stage assets like a long-acting PYY analog and anti-myostatin antibody.

• Emphasis on combination therapies and segmenting obesity treatment to address diverse patient needs and comorbidities.

• Manufacturing strategies leverage a global network and balance internal and external supply for scalability and cost management, with CT-996 as a true small molecule for easier production.

• The company leverages diagnostics and digital health platforms to provide holistic solutions for metabolic diseases.

Clinical Development and Data Updates

• CT-388 phase 1 showed robust, dose-dependent weight loss (~10% at 12 weeks [8 mg], ~19% at 24 weeks [22 mg]), with 100% achieving >5% and 85% >10% weight loss at 24 weeks; most AEs were mild/moderate and GI-related, with no unexpected safety signals or drug-related discontinuations.

• All participants who completed CT-388 treatment normalized glycemic status by week 24.

• Slower titration improved tolerability without compromising efficacy; majority achieved >10% weight loss, a clinically meaningful threshold.

• CT-996 phase 1 demonstrated up to 7.3% weight loss in four weeks at higher doses, with consistent replication across cohorts; PK supports once-daily dosing, no significant food effect, and low urinary excretion.

• Both assets are advancing to phase 2, with interim data expected in 2025 and phase 3 planning underway for CT-388.

Differentiation and Future Outlook

• Biased agonist design (reduced beta-arrestin signaling) may offer efficacy and tolerability advantages, though human data is pending.

• Oral GLP-1 (CT-996) is positioned as a differentiated, scalable, cost-effective solution compared to peptide-based orals.

• Portfolio strategy includes ongoing evaluation of additional gut hormone targets (e.g., GIP, PYY, amylin) and readiness for combination approaches.

• Market expectations are for multiple players and therapies by launch (2029+), with a focus on holistic patient solutions and weight maintenance.

• The company is positioned to expand into adjacent indications and leverage synergies with diagnostics and digital health.