Cybin Inc Stock Price, News & Analysis

Cybin Inc. (NYSE American:CYBN), a clinical-stage neuropsychiatry company, has reported its fiscal year 2025 financial results and business updates. The company is advancing its Phase 3 CYB003 PARADIGM program, which includes two 12-week studies (APPROACH™ and EMBRACE™) and a long-term extension study (EXTEND), targeting approximately 550 patients total.

Key clinical highlights include impressive Phase 2 results for CYB003 in major depressive disorder (MDD), where 100% of participants receiving two 16mg doses were responders and 71% achieved remission. The company is also progressing with its CYB004 Phase 2 study for generalized anxiety disorder, expected to complete around mid-2025.

Financially, Cybin reported cash reserves of C$135 million as of March 31, 2025. The company recorded a net loss of C$113 million for the fiscal year, compared to C$78 million in the previous year. Strategic partnerships have been established with Osmind for commercial preparations and Thermo Fisher Scientific for U.S.-based manufacturing.

Cybin (NYSE American: CYBN) has entered into a significant financing agreement with High Trail Special Situations LLC for up to US$500 million in convertible debentures. The initial tranche of US$50 million was completed on June 30, 2025, with the remaining US$450 million to be determined at a future date upon mutual agreement.

The convertible debentures feature a two-year term with a 5.5% annual interest rate, pre-paid at closing. The conversion price includes a potential 30% premium and is based on the lower of 130% of the pre-issuance VWAP or the 5-day VWAP prior to conversion.

The funding will accelerate Cybin's clinical programs, particularly CYB003, which showed a 71% remission rate in major depressive disorder at 12 months, and CYB004 for generalized anxiety disorder. The company's pipeline includes a multinational Phase 3 PARADIGM program for CYB003 and an ongoing Phase 2 GAD study for CYB004.

[ "Secured substantial financing of up to US$500 million through convertible debentures", "CYB003 demonstrated exceptional 71% remission rate in depression treatment with 12-month durability", "Received FDA Breakthrough Therapy Designation for CYB003", "Strong intellectual property portfolio with 90+ issued patents and 230+ pending applications", "Initial US$50 million funding completed with flexible terms for additional US$450 million", "Phase 3 PARADIGM program advancing with multiple near-term catalysts" ]

Cybin Inc. (NYSE:CYBN) has provided a corporate update highlighting significant progress in its psychedelic therapeutics development. The company is currently conducting Phase 3 PARADIGM trials for CYB003 in Major Depressive Disorder, targeting approximately 550 participants across three studies. Key partnerships have been established with Osmind for commercialization preparation, leveraging an 800-clinic network, and Thermo Fisher Scientific for U.S.-based manufacturing. The company has strengthened its intellectual property portfolio with two additional U.S. patents for CYB003 and CYB004 programs, bringing the total to over 90 granted patents. Notably, positive regulatory signals from U.S. agencies, including FDA Commissioner Dr. Makary's commitment to expedited review of psychedelics and increasing bipartisan support, suggest an improving regulatory environment for psychedelic medicine.

Cybin Inc. (NYSE American:CYBN), a clinical-stage neuropsychiatry company focused on developing innovative mental healthcare treatments, announced its participation in the H.C. Wainwright 6th Annual Neuro Perspectives Conference. CEO Doug Drysdale will engage in a virtual fireside chat that will be available on demand starting June 16, 2025, at 7:00 a.m. ET. The event, scheduled for June 16-17, 2025, will be accessible via webcast, with an archived version available on Cybin's investor relations website under the Events & Presentations section.

Cybin Inc. (NYSE American:CYBN) has announced its participation in the Psychedelic Science 2025 Conference, scheduled for June 16-20, 2025, in Denver, Colorado. CEO Doug Drysdale will join a panel discussion titled 'The Home Stretch: Pivotal Trials and Preparing for Launch' on June 19, 2025, at 9:30 a.m. MDT. The conference serves as a platform for global experts to discuss advancements in psychedelic therapeutics. Drysdale emphasized the company's commitment to developing innovative mental health treatment alternatives and noted the growing recognition of psychedelic therapeutics' potential within medical circles.

Cybin (NYSE:CYBN) has secured U.S. patent 12,318,477 for its CYB004 deuterated DMT program, strengthening protection for its novel formulations targeting Generalized Anxiety Disorder (GAD). The patent, extending until 2040, covers DMT and deuterated isotopologues for intramuscular injection. CYB004 is currently in Phase 2 clinical trials, with study completion expected by mid-2025. The company's robust intellectual property portfolio now includes over 90 granted patents and 230+ pending applications. CEO Doug Drysdale emphasized the significance of patent protection for their lead products and highlighted CYB004's potential to provide short-duration, rapid-acting anxiety treatment with patient-friendly intramuscular administration options.

Cybin Inc. (NYSE American:CYBN), a clinical-stage neuropsychiatry company, announces that CEO Doug Drysdale will participate in a Water Tower Research Fireside Chat on May 29, 2025, at 11:00 a.m. ET. The discussion, hosted by Senior Research Analyst Robert Sassoon, will cover several key topics including: the evolution of interventional psychiatry clinics and Cybin's Osmind partnership, updates on the CYB003 Phase 3 program, strategic clinical partnerships, the Thermo Fisher collaboration, upcoming milestones, and insights on FDA developments in psychedelics.

The FDA Commissioner Dr. Martin Makary has identified psychedelic drug development as a top agency priority, emphasizing the need to accelerate research for mental health treatments. This stance particularly benefits Cybin Inc. (CYBN), whose deuterated psilocin program CYB003 has received FDA Breakthrough Therapy Designation for major depressive disorder (MDD) treatment. The company's Phase 2 results showed remarkable efficacy, with 100% response rate and 71% remission rate in participants receiving two 16mg doses. Cybin is currently conducting its Phase 3 PARADIGM program, which includes two 12-week studies (APPROACH and EMBRACE) and a long-term extension study (EXTEND). Additionally, their CYB004 deuterated DMT program is progressing in Phase 2 trials for generalized anxiety disorder, expected to complete by mid-2025.

Cybin (NYSE:CYBN) has partnered with Thermo Fisher Scientific for Phase 3 clinical supply and potential commercial manufacturing of CYB003, its deuterated psilocin program for Major Depressive Disorder (MDD) treatment. The manufacturing operations will be based in the U.S., with drug substance production in Florence, South Carolina, and capsule production in Cincinnati, Ohio.

CYB003 received FDA Breakthrough Therapy Designation in March 2024, enabling expedited review and faster development. The program's Phase 2 results showed impressive efficacy with a 100% response rate and 71% remission rate among participants receiving two 16mg doses at 12 months. The company launched PARADIGM™, its multinational Phase 3 program, in November 2024 to evaluate CYB003 in a broader MDD patient population.