Cybin Inc Stock Price, News & Analysis

Cybin (NYSE American:CYBN) reported significant progress in its Q1 FY2026 and key milestones for its neuropsychiatry programs. The company received European and UK MHRA approval for EMBRACE, its second Phase 3 study of CYB003 for Major Depressive Disorder (MDD), which will enroll 330 participants across 60 clinical sites globally.

The company secured US$50 million in convertible debentures and reported cash reserves of US$118.7 million as of June 30, 2025. The PARADIGM program, including APPROACH and EMBRACE studies, will evaluate CYB003 in approximately 550 participants. Additionally, Cybin expects to complete patient enrollment for its CYB004 Phase 2 study in General Anxiety Disorder in August 2025.

Cybin (NYSE American:CYBN) has received European regulatory approval for EMBRACE, a pivotal Phase 3 study evaluating CYB003 for Major Depressive Disorder (MDD) treatment. The study will be conducted in Ireland, Poland, and Greece, following recent UK MHRA approval.

EMBRACE, part of the PARADIGM program, will enroll 330 participants across approximately 60 clinical sites globally. The study will evaluate two doses of CYB003 (16mg and 8mg) against placebo, with doses administered three weeks apart. Previous Phase 2 results showed remarkable efficacy, with 71% of participants achieving remission and 100% responding to treatment at 12 months after two 16mg doses.

CYB003, which has received FDA Breakthrough Therapy Designation, will be studied in patients with moderate to severe MDD who show inadequate response to current antidepressant treatments.

Cybin (NYSE American:CYBN), a clinical-stage neuropsychiatry company, announced its participation in the Canaccord Genuity 45th Annual Growth Conference. CEO Doug Drysdale will engage in a fireside chat on August 12, 2025, at 2:30 p.m. ET in Boston, MA.

The presentation will be accessible via live webcast and will later be available on the company's investor relations website under the Events & Presentations section.

Cybin (NYSE:CYBN) has received UK MHRA approval to commence EMBRACE, the second pivotal Phase 3 study within its PARADIGM program evaluating CYB003, a deuterated psilocin analog for Major Depressive Disorder (MDD).

The EMBRACE study will enroll 330 participants across approximately 60 clinical sites in the U.S., Europe, and Australia. The PARADIGM program, which includes APPROACH and EMBRACE studies plus EXTEND long-term extension, targets a total enrollment of 550 participants. The trial will evaluate two doses (16mg and 8mg) of CYB003 against placebo, administered three weeks apart.

Notably, CYB003 has received Breakthrough Therapy Designation from the FDA. The company highlighted encouraging market signals, referencing esketamine's commercial success with $414 million in worldwide Q2 2025 sales, representing 61.1% U.S. growth year-over-year.

Cybin (NYSE American: CYBN) has announced 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, prepaid at closing. The conversion price includes a potential 30% premium, calculated as the lower of 130% of the VWAP prior to issuance or the VWAP during the five trading days before 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 plans to use the proceeds for working capital and general corporate purposes, supporting its Phase 3 PARADIGM program and ongoing clinical trials.

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.