dimethyl fumarate (CU01) / Curacle - LARVOL DELTA

Phase IIb Clinical Trial for the Efficacy and Safety by CU01-1001 for 24 Weeks in Type 2 DM Patients With Albuminuria (clinicaltrials.gov) - P2 | N=240 | Completed | Sponsor: Curacle Co., Ltd. | Recruiting ➔ Completed | Phase classification: P2b ➔ P2 | Trial completion date: Sep 2024 ➔ Nov 2025 | Trial primary completion date: Sep 2024 ➔ Nov 2025

Phase classification • Trial completion • Trial completion date • Trial primary completion date • Diabetes • Diabetic Nephropathy • Nephrology • Renal Disease • Type 2 Diabetes Mellitus

Curacle, Shareholder Allocation Paid-in Capital Increase Decision… Expected Value Increase Through Progress in R&D Development of Major Pipelines such as CU06 and CU71 [Google translation] (Hankyung) - "Curacle...held a board meeting on the 16th and decided to increase capital through a public offering of common stock after allocating a total of 28.6 billion won to shareholders. The number of shares to be issued is 7 million, which is approximately 50% of the current number of issued shares...Curacle plans to focus the funds secured through this paid-in capital increase on R&D costs and operating funds for its main pipelines. The main uses are: Clinical phase 2b for retinal disease treatment drug CU06, Clinical phase 1 for Alzheimer's disease treatment drug CU71, and R&D progress for main pipelines such as CU01, MT-101, and MT-103....CU06 is a first-in-class new drug candidate under development as an oral retinal disease treatment, and is preparing to apply for an IND (clinical trial plan) for a phase 2b clinical trial in the second half of this year."

Financing • New P2b trial • Alzheimer's Disease • Diabetic Nephropathy • Retinal Disorders

Curacle, CU01 Diabetic Nephropathy Phase 2b Clinical Trial Patient Recruitment Completed [Google translation] (Newspim) - "Curacle...announced on the 18th that it has completed the recruitment of patients for the phase 2b clinical trial of CU01 for diabetic nephropathy. The clinical trial, which is currently being conducted with 240 patients in 24 university hospitals in Korea, is expected to end within the fourth quarter of this year, and discussions on technology transfer are also intensifying, the company explained....The diabetic nephropathy treatment market is expected to grow at an average annual rate of 4.5% amid such medical demand and expand to approximately KRW 6 trillion by 2032."

Enrollment closed • Sales • Trial completion date • Diabetic Nephropathy

Curacle, securing sales base… “6 new clinical drugs only, focusing on commercialization results this year” [Google translation] (Nate) - "First, its representative pipeline, diabetic macular edema treatment 'CU06', completed a meeting with the US Food and Drug Administration (FDA) last month in preparation for phase 2b clinical trials. It plans to submit an IND (Investigational New Drug) for phase 2b clinical trials this year. It is currently in technology transfer discussions with multiple companies....Curacle's diabetic nephropathy treatment 'CU01' is expected to complete phase 2b clinical trials this month. Clinical results will be available within the first half of this year."

IND • P2b data • Trial completion date • Diabetic Macular Edema • Diabetic Nephropathy