GBT-201 02

Development progress status of treatment for dry eye syndrome

	Progress status
Korea	• Approved IND for Phase IIb/III clinical trial to the Ministry of Food and Drug Safety • Completed to manufacture investigational medicinal product in Korea depending on the schedule of the clinical trial
United States	• Contracted with Ora, Inc., a CRO/SMO company in the US that specialized in ophthalmological diseases to conduct clinical trials in the US. Using the CAE™(Controlled Adverse Environment) model for more effective and rapid clinical trial of treatment for Dry Eye Syndrome • Completed a Phase IIb/III clinical trial(ARISE-1) of GBT-201 for the treatment of Dry Eye Syndrome in the US • Conducting a 2nd Phase III clinical trial(ARISE-2) of GBT-201 for treatment of Dry Eye Syndrome in the US • Approved by the U.S.-based joint venture (ReGenTree, LLC) 3rd phase (ARISE-3) of treatment of Dry Eye Syndromeㅍ (GBT-201) • treatment of Dry Eye Syndrome (GBT-201) Martket Access Study in progress • Completed investigational products manufacturing in a FDA cGMP-certified foreign CMO

Progress status

Korea

• Approved IND for Phase IIb/III clinical trial to the Ministry of Food and Drug Safety
• Completed to manufacture investigational medicinal product in Korea depending on the schedule of the clinical trial

United States

• Contracted with Ora, Inc., a CRO/SMO company in the US that specialized in ophthalmological diseases to conduct clinical trials in the US. Using the CAE™(Controlled Adverse Environment) model for more effective and rapid clinical trial of treatment for Dry Eye Syndrome
• Completed a Phase IIb/III clinical trial(ARISE-1) of GBT-201 for the treatment of Dry Eye Syndrome in the US
• Conducting a 2nd Phase III clinical trial(ARISE-2) of GBT-201 for treatment of Dry Eye Syndrome in the US
• Approved by the U.S.-based joint venture (ReGenTree, LLC) 3rd phase (ARISE-3) of treatment of Dry Eye Syndromeㅍ (GBT-201)
• treatment of Dry Eye Syndrome (GBT-201) Martket Access Study in progress
• Completed investigational products manufacturing in a FDA cGMP-certified foreign CMO

Development progress status of treatment for neurotrophic keratopathy

	Progress status
United States	• Received orphan drug designation from the US FDA. • Concluded contract with Ora, Inc., a CRO and SMO company that specializes in ophthalmic diseases for conducting Phase III clinical trial. • Conducting a Phase III clinical trial(SEER-1) of GBT-201 for treatment of Neurotrophic Keratopathy in the US • Completed investigational products manufacturing in a FDA cGMP-certified foreign CMO