NEW YORK, Sept. 24, 2025 (GLOBE NEWSWIRE) -- Pomerantz LLP is investigating claims on behalf of investors of Cybin Inc. (“Cybin” or the “Company”) (NYSE: CYBN). Such investors are advised to contact Danielle Peyton at newaction@pomlaw.com or 646-581-9980, ext. 7980. The investigation concerns whether Cybin and certain of its officers and/or directors have engaged in securities fraud or other unlawful business practices.  [Click here for information about joining the class action] We are investigating Cybin ...

or the "Company†), a clinical-stage breakthrough neuropsychiatry company committed to revolutionizing mental healthcare through proprietary drug discovery platforms and innovative delivery systems, today highlights significant clinical and regulatory milestones and upcoming value-driving catalysts as the Company advances multiple programs towards potential commercialization. "We have established a leading position. TORONTO--(BUSINESS WIRE)--Cybin Inc. (NYSE American:CYBN) (Cboe CA:CYBN) (†Cybin†...

Summary of Cybin Inc. Conference Call Company Overview - **Company**: Cybin Inc. - **Lead Product**: CYB003, a deuterated psilocybin compound in clinical development for adjunctive treatment of major depressive disorder (MDD) [1][2] Key Points Product Advantages - **Deuterated Psilocybin**: CYB003 offers advantages over naturally occurring psilocybin by removing the metabolic step, leading to reduced variability and a more stable formulation [2][3] - **Intellectual Property**: Cybin holds over 100 granted patents and more than 250 pending patents related to CYB003, establishing a strong intellectual property position [4][5] Clinical Program - **Paradigm Program**: The Phase 3 program includes pivotal studies named Approach and Embrace, with a total enrollment of 550 patients across both studies [7][9] - **Study Designs**: - **Approach**: Two-arm study comparing 16 mg of CYB003 with placebo, with a primary endpoint at six weeks and a secondary endpoint at 12 weeks [8][9] - **Embrace**: Three-arm study including an inert placebo, an intermediate dose of 8 mg, and the active dose of 16 mg, with a total of 330 patients [9][13] - **Enrollment Status**: Enrollment for Approach is underway in the US, with approximately 45 sites involved, aiming for top-line data by the end of 2026 [9][12] Efficacy and Safety - **Expected Outcomes**: Previous Phase 2 data showed a differentiation of about 14 points on the MADRS scale from placebo. Even a reduced effect in Phase 3 would still be significant compared to historical data for SSRIs [28][29] - **Durability of Effect**: The long-term extension study aims to demonstrate the durability of the treatment effects, with expectations of data on how long patients remain in response or remission [32][29] Regulatory and Design Considerations - **FDA Guidance**: The study designs have been endorsed by the FDA, which allows for regular discussions regarding the trial's progress and design [18][19] - **Blinding Measures**: The studies will employ a randomized double-blind approach, with measures in place to reduce functional unblinding [19][23] Commercial Strategy - **Market Positioning**: CYB003 is positioned as a treatment for patients with inadequate responses to traditional SSRIs and SNRIs, with a focus on interventional psychiatry centers [41][36] - **Partnerships**: Cybin has partnered with Osmind to better understand patient experiences and clinical workflows relevant to commercialization [38][39] Future Developments - **CYB004 for GAD**: Cybin is also developing CYB004, a deuterated DMT for generalized anxiety disorder (GAD), with a Phase 2 study expected to deliver top-line data in Q1 2026 [42][45] - **Study Design for GAD**: The Phase 2 study will compare a low-dose control with an active dose, focusing on the HAM-A scale for primary endpoints [46][47] Additional Insights - **Patient Experience**: The treatment is designed to be administered in a day treatment setting, allowing for a streamlined patient experience [40][36] - **Market Need**: There is a significant market opportunity for GAD treatments, with a global prevalence of approximately 300 million patients [42][43]

Core Viewpoint - Pomerantz LLP is investigating potential securities fraud and unlawful business practices involving Cybin Inc. and its officers or directors [1][3]. Group 1: Investigation Details - The investigation is focused on claims made by investors of Cybin Inc. regarding possible violations of federal securities laws [3]. - On September 2, 2025, Cybin announced the resignation of its CEO, Doug Drysdale, which led to a significant drop in the company's stock price by $1.24 per share, or 16.58%, closing at $6.24 per share [3]. Group 2: Company Background - Pomerantz LLP is recognized as a leading firm in corporate, securities, and antitrust class litigation, with a history of over 85 years in fighting for victims of securities fraud and corporate misconduct [4].

Core Viewpoint - Cybin Inc. is under investigation by the Schall Law Firm for potential violations of securities laws, particularly regarding misleading statements and failure to disclose important information to investors [2]. Company Summary - The investigation is focused on whether Cybin issued false or misleading statements or failed to disclose relevant information to investors [2]. - Following the announcement of CEO Doug Drysdale's resignation on September 2, 2025, Cybin's shares dropped by over 16.5% on the same day [2]. Legal Context - The Schall Law Firm is representing investors globally and specializes in securities class action lawsuits and shareholder rights litigation [3].

Group 1 - Cybin Inc. is a clinical-stage neuropsychiatry company focused on developing innovative treatment options for mental healthcare [1] - The company announced participation in a fireside chat at TD Cowen's 5th Annual Novel Mechanisms in Neuropsychiatry & Epilepsy [1] - Key executives, including the Chief Medical Officer and Chief Business Officer, will represent the company during the event [1]

Core Viewpoint - Pomerantz LLP is investigating potential securities fraud and unlawful business practices involving Cybin Inc. and its officers or directors [1][2]. Group 1: Company Overview - Cybin Inc. (NYSE: CYBN) is currently under investigation for possible violations of federal securities laws [2]. - Doug Drysdale has stepped down as the Chief Executive Officer of Cybin effective September 2, 2025 [2]. Group 2: Market Reaction - Following the announcement of Doug Drysdale's resignation, Cybin's stock price decreased by $1.24 per share, representing a decline of 16.58%, closing at $6.24 per share on September 2, 2025 [2]. Group 3: Legal Context - Pomerantz LLP is recognized for its expertise in corporate, securities, and antitrust class litigation, having a history of recovering multimillion-dollar damages for victims of securities fraud and corporate misconduct [3].

Summary of Cybin Inc. FY Conference Call (September 08, 2025) Company Overview - **Company**: Cybin Inc. (NYSEAM:CYBN) - **Industry**: Neuropsychiatry, focusing on next-generation psychedelics and neuromodulators for mental health - **Key Products**: - CYB003: Deuterated psilocin analog for major depressive disorder (MDD) - CYB004: Deuterated DMT compound for generalized anxiety disorder (GAD) [1][2] Core Points and Arguments Treatment Landscape - Traditional treatments for mood disorders like depression and anxiety often involve chronic daily dosing with SSRIs and SNRIs, with two-thirds of patients not responding initially [2] - Side effects from current treatments can be significant, including sexual dysfunction and weight gain [2] - Interventional psychiatry has emerged, utilizing treatments like TMS and S-Ketamine, but access remains limited due to administrative burdens [3][4] Cybin's Approach - Cybin aims to evolve the interventional paradigm by offering treatments that require significantly less frequent dosing, potentially only two doses per year [4] - CYB003 has received FDA Breakthrough Therapy Designation and is currently in a phase 3 program (APPROACH) for MDD, with a second study (EMBRACE) expected to start soon [4][5] Clinical Data - In a phase 2 trial for CYB003, a 100% response rate and a 71% remission rate at 12 months were reported, with an average drop of 23 points on the MADRS scale [10][11] - The phase 3 program (PARADIGM) includes 550 patients across two studies, with a long-term extension to assess durability and redosing profiles [13][14][18] Mechanism of Action - CYB003 acts as an agonist at various serotonin receptors, hypothesized to induce a window of plasticity in the brain, allowing for rapid reorganization of maladaptive thinking patterns [9] - CYB004 is delivered via intramuscular injection, with a shorter duration of effect, aimed at treating moderate to severe GAD [26] Market Opportunity - The U.S. market for SSRIs and SNRIs is substantial, with approximately 15% of the population on these medications [36] - Spravato, a similar treatment, has generated $1.6 billion in sales, indicating a significant market potential for Cybin's products [36] Future Directions - Cybin is exploring potential expansions for both CYB003 and CYB004 into other mood and behavioral disorders, including addiction [33][34] - The collaboration with OZMINE, which operates an 800 clinic network, is expected to enhance clinical and commercial readiness for Cybin's treatments [35] Important but Overlooked Content - The long-term extension study (EXTEND) aims to understand the efficacy and durability of treatment effects over time, as well as the redosing profile for patients who may relapse [18][20] - The company anticipates providing top-line data for CYB004 in Q1 of the following year, with expectations for the first phase 3 study (APPROACH) data by the end of the current year [41]

Core Insights - Cybin Inc. has completed enrollment in its Phase 2 study for CYB004, a proprietary deuterated dimethyltryptamine (DMT) program aimed at treating Generalized Anxiety Disorder (GAD) [1] - The company reaffirms its top line data guidance for the study [1] Company Overview - Cybin Inc. is a clinical-stage neuropsychiatry company focused on advancing mental healthcare through innovative treatment options [1] - The company is listed on NYSE American and Cboe CA under the ticker symbol CYBN [1]

Summary of Cybin Inc. Conference Call Company Overview - **Company**: Cybin Inc. (CYBN) - **Industry**: Biopharmaceuticals focusing on mental health disorders - **Key Focus**: Development of psychedelic compounds for treating mental health issues, specifically major depressive disorder (MDD) and generalized anxiety disorder (GAD) [4][5] Core Programs - **CYB003**: Deuterated psilocin, currently in Phase 3 trials for MDD, has received FDA breakthrough therapy designation [5][10] - **CYB004**: Deuterated dimethyltryptamine (DMT), in proof-of-concept study for GAD, with top-line data expected early next year [5][50] Key Differentiators - **Mechanism of Action**: Psychedelics target underlying maladaptive thinking patterns rather than just symptoms, offering potential for long-lasting effects [5][9] - **Dosing Certainty**: CYB003 is not a prodrug, providing certainty in dosing compared to traditional psilocybin [11] - **Intellectual Property**: Deuteration provides additional intellectual property protection while retaining pharmacological properties [11] Clinical Trial Design and Efficacy - **Phase 2 Study**: Showed significant efficacy with a response of approximately 14 points on the MADRS scale, compared to 2-3 points for SSRIs [25][26] - **Long-term Efficacy**: 71% of patients on the 16 mg dose were in remission after one year following just two doses [26] - **Phase 3 Studies**: Two studies (Approach and Embrace) designed to assess efficacy and safety, with a total of about 550 patients [28][29] Regulatory Strategy - **FDA Engagement**: Regular discussions with the FDA to ensure compliance and address concerns regarding psychedelic therapies [28] - **Adjunctive Treatment Approach**: Focus on treating patients earlier in the MDD spectrum rather than targeting treatment-resistant depression (TRD) to improve trial success rates [13][18] Safety and Monitoring - **Monitoring Protocols**: Patients will be closely monitored during treatment sessions, with assessments every 15 minutes to ensure safety [45][47] - **Session Structure**: No active psychotherapy during acute psychedelic experiences; focus on internal work with supportive monitoring [49] Future Expectations - **Upcoming Data Releases**: Anticipation of top-line data for CYB004 in Q1 next year and completion of enrollment for CYB003's Phase 3 study by summer next year [50] Additional Insights - **Market Potential**: The company aims to change the treatment landscape for mental health disorders, potentially rewriting psychiatric textbooks [9] - **Challenges in Clinical Trials**: Acknowledgment of the difficulties in demonstrating efficacy in larger trials, with a conservative approach to powering assumptions for Phase 3 studies [37] This summary encapsulates the key points discussed during the conference call, highlighting Cybin Inc.'s innovative approach to mental health treatment through psychedelic compounds and its strategic plans for clinical development and regulatory engagement.