Cybin Inc Stock Price, News & Analysis

Cybin Inc. (NYSE American:CYBN) (Cboe CA:CYBN) has announced plans to initiate a Phase 3 pivotal trial of CYB003 for the adjunctive treatment of Major Depressive Disorder (MDD) in late summer 2024. This follows a successful Type B Initial Breakthrough Therapy Meeting with the FDA. The trial will include 30 clinical sites across the United States and Europe. Cybin's Phase 2 study showed promising results, with 75% of patients in remission from depression four months after two 16mg doses of CYB003. The company plans to implement measures to mitigate functional unblinding risks in the pivotal study, including a three-arm design and the use of remote, independent, blinded raters. Cybin expects to report 12-month efficacy data from the Phase 2 study in Q4 2024.

Cybin Inc. (NYSE American:CYBN) (Cboe CA:CYBN) reported its Q1 FY2025 financial results and recent business highlights. Key points include:

- Phase 3 multinational study of CYB003 for Major Depressive Disorder (MDD) expected to begin in late summer 2024 across 30 clinical sites in the US and Europe

- 12-month efficacy results from Phase 2 study of CYB003 in MDD expected Q4 2024

- Additional US patent granted for the CYB004 program

- Strengthened R&D team with experienced drug development leaders

- Cash totaled C$183 million as of June 30, 2024

- Net loss was C$15 million for Q1 FY2025

- Cash-based operating expenses were C$16 million for Q1 FY2025

- Cash flows used in operating activities were C$27 million for Q1 FY2025

Cybin Inc. (NYSE American:CYBN) (Cboe CA:CYBN), a clinical-stage neuropsychiatry company, announces its participation in the Canaccord Genuity 44th Annual Growth Conference. The event is scheduled for August 13-14, 2024 in Boston, MA. Doug Drysdale, Cybin's CEO, will engage in a fireside chat on Tuesday, August 13, 2024, at 2:00 p.m. ET.

The fireside chat will be webcast live and accessible to the public. An archived version of the webcast will be available on Cybin's investor relations website under the Events & Presentations page. This participation highlights Cybin's commitment to developing innovative next-generation treatment options in mental healthcare.

Cybin Inc. (NYSE American: CYBN) has announced significant insider stock purchases, highlighting confidence in the company's direction. Senior officers and directors have collectively acquired substantial shares, reinforcing faith in Cybin's strategic advancements. The company has achieved notable milestones, including FDA Breakthrough Therapy Designation for CYB003 for major depressive disorder (MDD) and positive Phase 2 results, showing a 14-point MADRS score reduction. Cybin is set to launch a Phase 3 study for CYB003 and a Phase 2 study for CYB004 targeting generalized anxiety disorder (GAD). Financially, Cybin is robust, with C$209 million in cash reserves as of March 31, 2024, and a recent US$150 million private placement. Zacks Investment Research upgraded Cybin to a Zacks Rank #2 (Buy), citing a 52.6% improvement in earnings estimates for FY 2025.

Cybin reported its Fiscal Year 2024 financial results, highlighting several key developments. The company received FDA Breakthrough Therapy Designation (BTD) for CYB003, its deuterated psilocybin analog for Major Depressive Disorder (MDD), and completed site selection for a Phase 3 study scheduled for summer 2024. Cash reserves totaled C$209 million as of March 31, 2024. CYB004, targeting Generalized Anxiety Disorder (GAD), advanced to Phase 2 trials. Cybin closed a US$150 million private placement and bolstered its patent portfolio with over 60 granted patents. Financial highlights include a net loss of C$78 million for the year, increased operating expenses, and substantial cash inflows from financing activities.

Cybin, a clinical-stage biopharmaceutical company focused on next-generation psychedelic treatments for mental health, announced that CEO Doug Drysdale will participate in the H.C. Wainwright 5th Annual Neuro Perspectives Virtual Conference. The event is scheduled for June 27, 2024, and Drysdale's fireside chat will be available on demand starting at 7:00 a.m. ET. The webcast can be accessed via a link provided in the announcement and will be archived on Cybin's investor relations website.

Cybin has appointed Dr. Atul Mahableshwarkar as Senior Vice President of Clinical Development. With extensive experience in drug development and psychiatry, he will lead the CYB003 program, Cybin's deuterated psilocybin analog, which has FDA Breakthrough Therapy Designation for major depressive disorder. Dr. Mahableshwarkar’s expertise is expected to accelerate Cybin’s clinical trials, including the imminent Phase 3 study of CYB003 and Phase 2 study of CYB004 for Generalized Anxiety Disorder. His background includes global Phase 3 program management and regulatory submissions, which could be pivotal for Cybin’s growth.

Cybin, a clinical-stage biopharmaceutical company, will participate in significant events on June 5-8, 2024. Chief Medical Officer Amir Inamdar will discuss marketing approval and access pathways for psychedelics at two panels. Ellen James, Director of Clinical Development, will present research on SPL026 (DMT fumarate) combined with SSRIs for treating Major Depressive Disorder. Cybin's advancements in CYB003 and CYB004 for mental health treatment will also be highlighted, including the recent FDA Breakthrough Therapy Designation for CYB003 and positive Phase 2 trial results.

Cybin, a clinical-stage biopharmaceutical company, announced that CEO Doug Drysdale will participate in a virtual fireside chat at the Alliance Global Partners Healthcare Company Showcase on May 21, 2024. The presentation will be webcast live at 12:40 p.m. ET and will later be available on Cybin’s investor relations website. The company is focused on developing innovative psychedelic treatments for mental healthcare.