Andrew Partheniou

Charles Duncan

François Brisebois

Sumant Kulkarni

Elemer Piros

Jason Shieh

Michael Okunewitch

Patrick Trucchio

Sepehr Manochehry

- **CYBIN Inc.** has received **Australian approval** to conduct the **EMBRACE study**, a multinational pivotal study evaluating **CYB003** for the adjunctive treatment of Major Depressive Disorder (MDD).  **[1833141_0001833141-25-000012_a08-26x2025australiatgaemb.htm:0]** 
- This approval follows previous clearances to initiate the EMBRACE study in **Ireland, Poland, Greece, and the United Kingdom**, enabling the study to proceed across three continents.  **[1833141_0001833141-25-000012_a08-26x2025australiatgaemb.htm:0]** 
- EMBRACE is the **second pivotal study** in the **CYB003 Phase 3 PARADIGM program**, which is expected to enroll a total of **550 participants** across three studies, with EMBRACE specifically targeting **330 participants** across approximately **60 clinical sites** in the U.S., Europe, and Australia.  **[1833141_0001833141-25-000012_a08-26x2025australiatgaemb.htm:0]** **[1833141_0001833141-25-000012_a08-26x2025australiatgaemb.htm:1]** 
- **CYB003** has received **Breakthrough Therapy Designation** from the U.S. Food and Drug Administration for MDD, and prior Phase 2 data showed **71% of participants in remission** and **100% response rate at 12 months** after two doses.  **[1833141_0001833141-25-000012_a08-26x2025australiatgaemb.htm:0]**

CYBIN Receives Australian Approval for EMBRACE Study

CYBIN (CYBN)