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200 mL intravenous infusion on Day 1 and Day 8: CNP-106

CNP-106 is comprised of an antigenic AChR Peptide Pool (\~1 μg of each AChRα and AChRε peptide comprising AChR Peptide Pool Drug Substance per mg particles) dispersed within a negatively charged (-30 to -60 mV) polymer matrix of PLGA (Poly (DL-lactide-co-glycolide, 50:50 acid-end group)) particles (400-800 nm in size).

CNP-106

Placebo

Jason Penix

Lynlee Muehring

Nicole Turcotte

Shafeeq Ladha, MD

Lucia Rodriguez

Kumaraswamy Sivakumar, MD

Danielle Mendoza

Derrick Florin, MD

Archita Patel

Ali A Habib, MD

Erika Renkl

Bhaskar Roy, MD

Hector Fernandez

Sergio Jaramillo, MD

Naraly Requena

Tuan Vu, MD

Abby Davis

Mazen DiMachkie

Sarah Hilbert

Jeffrey Allen, MD

Julie Agriesti

Miriam Freimer, MD

Alison Line

Katherine Ruzhansky, MD

Amy Megerle

Aziz Shaibani, MD

Taylor Parkinson

Gordon Smith, MD, FAAN

Roy First, MD

Phase 1b/2a First-in-Human (FIH) clinical trial to assess the safety, tolerability, pharmacodynamics (PD), and efficacy of multiple ascending doses of CNP-106.

This is a Phase 1b/2a First-in-Human (FIH) clinical trial to assess the safety, tolerability, pharmacodynamics (PD), and efficacy of multiple ascending doses of CNP-106. The clinical study lasts 222-days (up to 42 days for Screening, 180 Study Days). Subjects ages 18-75 with generalized myasthenia gravis (MG) will be screened up to 42 days prior to enrollment into the clinical study.

Evaluate the Safety, Tolerability, Pharmacodynamics and Efficacy of CNP-106 in Subjects With Myasthenia Gravis

A Phase 1b/2a Double Blind, Placebo Controlled Study to Evaluate the Safety, Tolerability, Pharmacodynamics, and Efficacy of CNP-106 in Subjects Ages 18-75 With Generalized Myasthenia Gravis

Frequency tables will be presented by treatment group for all AEs and SAEs by System Organ Class (SOC) and Preferred Term (PT). Frequency tables will also be produced by treatment group for AEs leading to COUR Pharmaceuticals Development Company, Inc. Confidential CNP-106-5.001 Protocol; IND 28774 Page 53 of 65 discontinuation from IP and study, by severity, and by causality. No formal statistical testing will be done.

The mean change from Baseline to the endpoint within CNP-106 and Placebo treatment groups will be analyzed using ANOVA.

COUR Pharmaceutical Development Company, Inc.

Spots Global Cancer Trial Database for generalized myasthenia