Cybin(CYBN)
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Cybin Completes Enrollment in Phase 2 Study Evaluating CYB004 for the Treatment of Generalized Anxiety Disorder
Businesswire· 2025-09-08 11:30
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]
Cybin (CYBN) 2025 Conference Transcript
2025-09-05 15:20
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.
Cybin(CYBN) - 2025 FY - Earnings Call Transcript
2025-08-18 15:00
Financial Data and Key Metrics Changes - The company has transitioned to a Phase III company, indicating significant progress in its clinical development [21] - CYB3 demonstrated a 71% remission rate in patients with uncontrolled depression after just two doses in a Phase II study, showcasing a substantial efficacy advantage over standard treatments [24] Business Line Data and Key Metrics Changes - The company is advancing its lead program CYB3, which is in the final stage of development for treating major depressive disorder (MDD) [22] - CYB4, a program for generalized anxiety disorder (GAD), is in a Phase II proof of concept study, with enrollment expected to complete in August 2025 [29] Market Data and Key Metrics Changes - The commercial success of esketamine, with sales of $366 million in the US and $414 million worldwide, reflects a growing market for innovative mental health treatments [32] - The company is witnessing a supportive political and regulatory environment, which is expected to expedite regulatory pathways for psychedelic therapies [31] Company Strategy and Development Direction - The company is focused on executing its clinical programs while preparing for regulatory submissions and commercial manufacturing readiness [28] - Strategic collaborations with Thermo Fisher Scientific and AusMind are aimed at enhancing manufacturing capabilities and supporting commercial preparation [27] Management's Comments on Operating Environment and Future Outlook - The management expressed optimism about the regulatory environment, citing bipartisan support and positive signals from US agencies [31] - The company is well-capitalized and positioned for multiple near-term inflection points in its clinical programs, reinforcing its leadership in the sector [34] Other Important Information - The company has significantly expanded its intellectual property portfolio, now comprising over 100 granted patents and more than 250 pending applications [30] - The EMBRACE study will enroll approximately 330 participants across 60 clinical sites in the US, Europe, and Australia, indicating a robust international research base [26] Q&A Session Summary Question: What is the current status of the clinical programs? - The company is currently in Phase III for CYB3 and expects to have top-line readout in 2026, with ongoing enrollment in the EMBRACE study [28][34] Question: How does the company view the regulatory environment? - Management highlighted a positive shift in the regulatory landscape, with increased support from government officials and agencies, which is expected to benefit the entire sector [31]
Cybin (CYBN) FY Conference Transcript
2025-08-12 19:30
Summary of Cybin (CYBN) FY Conference Call - August 12, 2025 Company Overview - **Company**: Cybin (CYBN) - **Focus**: Development of psychedelic treatments for mental health conditions, particularly Major Depressive Disorder (MDD) Key Points Industry Context - **Target Population**: Cybin is focusing on adjunctive treatment for MDD, particularly for patients who have already undergone multiple treatment trials, typically four to six, before reaching third-line treatment options [1][2] - **Market Size**: Approximately 3.5 million patients in the U.S. are targeted for third-line MDD treatment [2] Product Development and Efficacy - **Durability of Effect**: The company aims for treatments to provide relief from depression for at least six months, with a goal of one year of remission after just two doses [3][4] - **Phase Three Program**: Patients will be followed for a year post-dosing, with opportunities for re-dosing if they relapse [5] - **Expected Outcomes**: Anticipated metrics for success include reduction in MADRS scores, relapse and remission rates, and response rates [11] Safety and Tolerability - **Adverse Events**: No serious adverse events reported; transient side effects include nausea and elevated blood pressure during dosing sessions [9][10] - **Monitoring**: Adverse events will be tracked throughout the study, not just during dosing periods [10] Pricing and Market Positioning - **Pricing Strategy**: Current benchmark for similar treatments (e.g., SPRAVATO) is $30,000 to $50,000 per year; Cybin's treatment is expected to be more cost-effective with only two doses per year compared to 26 for esketamine [6][27] - **Market Potential**: Esketamine's sales run rate is approximately $1.7 billion, with expectations to reach $3-4 billion in a few years [28] Competitive Landscape - **Payer Engagement**: Positive interactions with payers, who view CYB3 as a viable third-line option due to its dosing convenience [26] - **Comparison with Competitors**: Cybin's treatment is positioned favorably against existing options due to fewer required doses and potentially better patient adherence [27] Clinical Trial Insights - **Placebo Response**: Observed a placebo response in phase two trials, with a reduction in MADRS scores of about eight points initially, reverting to baseline by the primary endpoint [19][20] - **Expectations for Phase Three**: Clinically relevant outcomes are expected to show a reduction of two to three points on the MADRS scale, with a target of maintaining a significant effect size compared to existing treatments [22] Future Outlook - **Upcoming Data**: Top-line data from the CYB004 trial is expected by the end of the year, following a twelve-week blinded period [30] - **Strategic Interest**: Increased interest from larger biopharma companies in acquiring assets in the psychedelic treatment space, particularly as data becomes available [41][43] Conclusion - **Innovative Approach**: Cybin is positioned to potentially change the treatment landscape for depression with its novel psychedelic therapies, focusing on efficacy, safety, and patient convenience [16][24]
Wall Street Analysts See an 831.44% Upside in Cybin Inc. (CYBN): Can the Stock Really Move This High?
ZACKS· 2025-07-18 14:56
Core Viewpoint - Cybin Inc. (CYBN) shows significant upside potential based on Wall Street analysts' short-term price targets, with a mean target of $78.8 indicating an 831.4% upside from the current price of $8.46 [1][2]. Price Targets and Estimates - The average price target consists of five estimates ranging from a low of $25.00 to a high of $150.00, with a standard deviation of $52.91, indicating variability among analysts [2]. - The lowest estimate suggests a 195.5% increase, while the highest points to a 1673.1% upside [2]. - A low standard deviation indicates a strong agreement among analysts regarding the price movement direction [9]. Analyst Sentiment and Earnings Estimates - Analysts exhibit strong agreement in revising CYBN's earnings estimates higher, which correlates with potential stock price increases [4][11]. - The Zacks Consensus Estimate for the current year has risen by 3.1% over the past month, with two estimates increasing and no negative revisions [12]. - CYBN holds a Zacks Rank 2 (Buy), placing it in the top 20% of over 4,000 ranked stocks based on earnings estimate factors [13]. Caution on Price Targets - While price targets are a common tool for investors, they can often mislead, and reliance solely on them may not yield favorable returns [3][10]. - Analysts may set overly optimistic price targets due to business incentives, which can inflate expectations [8].
3 High-Risk, High-Reward Stocks With Explosive Upside
MarketBeat· 2025-07-16 13:46
Industry Overview - The most promising industries for investment in mid-2025 are artificial intelligence (AI), specifically AI-based consumer engagement and autonomous vehicles, along with the biotech sector focusing on psychedelic-based therapies for mental health [1] Company: Rezolve AI - Rezolve AI has achieved significant growth with 16.5 million monthly active users and over $50 billion in gross merchandise value (GMV) processed in 2025 [3] - The company reported over $70 million in annual recurring revenue (ARR) ahead of schedule, with a target of $100 million in ARR by the end of 2025 [3] - Rezolve was added to the Russell 2000 and Russell 3000 indices, and analysts have a consensus price target of $6 per share, indicating a potential upside of 148% [4] Company: Aurora Innovation - Aurora Innovation has launched a Lidar-based commercial self-driving truck service in Texas, marking a significant operational milestone [7] - The company is recognized for its self-driving software system, Aurora Driver, which has the potential to revolutionize freight logistics [6][7] - Analysts have set a 12-month price target of $10.75 for Aurora, suggesting an upside of 85.66% [5][6] Company: Cybin - Cybin is developing psychedelic-based treatments for mental health disorders, with two lead candidates in advanced clinical trials [10] - Analysts project a price target of $85 per share for Cybin, representing an upside potential of 1,041.71% [10][11] - The company is currently pre-revenue, which adds a layer of risk to its investment profile [12]
Cybin (CYBN) Fireside Chat Transcript
2025-05-29 16:00
Summary of Cybin (CYBN) Fireside Chat - May 29, 2025 Company Overview - **Company**: Cybin (CYBN) - **Industry**: Neuropsychiatry and Mental Health Care - **Focus**: Development of novel treatment options for mental health disorders, particularly major depressive disorder through its lead candidate CYB003 [1][4] Key Points and Arguments Clinical Landscape and Infrastructure - The interventional psychiatry landscape in the US is evolving with approximately 5,000 clinics offering various mental health services, including ECT, TMS, and ketamine treatments [5][6] - These clinics are primarily physician-owned or private equity-owned, equipped with treatment rooms and centralized monitoring systems, making them suitable for administering psychedelic treatments [6][7] - The infrastructure is expected to grow, providing a solid foundation for the distribution and administration of Cybin's treatments [9] Partnership with Osmin - The partnership with Osmin is seen as a strategic opportunity to enhance commercial preparation and understand clinic resources, workflows, and profitability factors [12][13] - Osmin operates in about 800 interventional psychiatry clinics, providing valuable insights into patient journeys, treatment protocols, and reimbursement patterns [12][14] Phase Three Clinical Trials - Cybin is currently engaged with 45 clinical trial sites in the US, identifying 18 core sites expected to deliver high patient volumes [15][16] - Strategic partnership agreements are aimed at aligning resources and incentives with these core sites to ensure successful trial execution [15][16] - The company is focused on maintaining quality in patient selection and trial execution amidst competition for resources in the psychedelic research space [24][25] Manufacturing and Supply Chain - Cybin has a manufacturing agreement with Thermo Fisher, a leading CDMO, ensuring robust supply chain capabilities for both trial and future commercial needs [19][20] - The partnership allows for US-based manufacturing, mitigating importation and tariff concerns, while also retaining the option to qualify additional suppliers as backups [21][22] Regulatory Environment - Interactions with the FDA have been positive, with active engagement and responsiveness noted during meetings, indicating a favorable regulatory environment for psychedelic drug development [28][30] - The company perceives no issues with timelines or responsiveness from the FDA, which is encouraging for future drug approvals [30][31] Upcoming Milestones - The first short-term study for CYB003 is underway, with results expected in the second half of 2026 [23] - The next phase three study, EMbrace, is planned to start mid-year, alongside ongoing phase two studies for CYB4 [24] Additional Important Content - The emergence of a for-profit network of interventional psychiatry centers driven by demand is seen as beneficial for patient access to mental health treatments [6] - The company emphasizes the importance of understanding the nuances of clinic operations and patient experiences to facilitate a successful product launch [14] This summary encapsulates the critical insights and developments discussed during the fireside chat, highlighting Cybin's strategic initiatives and the evolving landscape of mental health treatment.
Cybin Inc. (CYBN) Loses -25.81% in 4 Weeks, Here's Why a Trend Reversal May be Around the Corner
ZACKS· 2025-03-04 15:35
Group 1 - Cybin Inc. (CYBN) has experienced significant selling pressure, resulting in a 25.8% decline over the past four weeks, but it is now considered oversold, indicating potential for recovery [1] - The Relative Strength Index (RSI) for CYBN is currently at 20.7, suggesting that the heavy selling may be exhausting, which could lead to a price rebound [5] - Analysts have raised earnings estimates for CYBN by 1.6% over the last 30 days, indicating a positive trend that typically correlates with price appreciation [6] Group 2 - CYBN holds a Zacks Rank 2 (Buy), placing it in the top 20% of over 4,000 ranked stocks based on earnings estimate revisions and EPS surprises, further supporting the potential for a turnaround [7]
Wall Street Analysts Think Cybin Inc. (CYBN) Could Surge 988.67%: Read This Before Placing a Bet
ZACKS· 2025-02-17 15:55
Core Viewpoint - Cybin Inc. (CYBN) shows significant upside potential based on Wall Street analysts' short-term price targets, with a mean target of $103.75 indicating a potential increase of 988.7% from the current price of $9.53 [1] Price Targets and Estimates - The mean estimate consists of four short-term price targets with a standard deviation of $68.46, where the lowest estimate of $25 suggests a 162.3% increase, and the highest estimate of $190 indicates a potential surge of 1893.7% [2] - A low standard deviation among price targets suggests a high degree of agreement among analysts regarding the stock's price movement direction, although it does not guarantee that the stock will reach the average target [7] Earnings Estimates and Analyst Sentiment - Analysts are optimistic about CYBN's earnings prospects, as indicated by a positive trend in earnings estimate revisions, which has shown a strong correlation with near-term stock price movements [9] - The Zacks Consensus Estimate for the current year has increased by 0.9% over the past month, with one estimate rising and no negative revisions [10] - CYBN holds a Zacks Rank 2 (Buy), placing it in the top 20% of over 4,000 ranked stocks based on earnings estimate factors, indicating strong potential for upside [11] Caution on Price Targets - While price targets are often sought after by investors, they can be misleading and should not be the sole basis for investment decisions [5][8] - Analysts may set overly optimistic price targets due to business incentives, which can inflate expectations [6]
Cybin: Top Value Psychedelic Stock
Seeking Alpha· 2024-10-15 16:30
Group 1 - The psychedelic medicine sector presents unique value investment opportunities, characterized as a biotech sector that is still in its early stages but has reached advanced clinical trials and gained institutional support [1] - The sector offers substantial room for growth, indicating potential for significant returns on investment as it matures [1]