Cybin (CYBN) Fireside Chat May 29, 2025 11:00 AM ET Speaker0 Drysdale for this fireside chat. Cybin is a late stage breakthrough neuropsychiatry company committed to revolutionizing mental health care by developing novel next generation treatment options to address the large unmet need. The phase three program for CYBN's lead CYB003 candidate for the injunctive treatment of major depressive disorder is underway and currently dosing. Cybin trades on the NYSE American and CBOE Canada under the ticker CYBN. An ...

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]

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]

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]

Company Overview - Cybin, Inc. is positioned as a leader in the development of novel neuropsychiatry therapeutics, focusing on hard-to-treat mental health disorders such as major depressive disorder (MDD) and generalized anxiety disorder (GAD) [2] - The company is guided by an experienced executive management team with extensive pharmaceutical industry knowledge and claims to have the most comprehensive intellectual property (IP) portfolio among its peers [2] Pipeline Development - Cybin's primary pipeline candidates include CYB003, a deuterated psilocin-based treatment for MDD, and CYB004, a deuterated N,N-Dimethyltryptamine (DMT) targeting GAD [3] - CYB003 is expected to initiate its first Phase III study by the end of 2024 following positive Phase II results, while CYB004 is nearing the completion of its Phase II trial with results anticipated by the end of 2024 or early 2025 [3] Technological Differentiation - The company utilizes deuteration to enhance the pharmacokinetic properties of its treatments, resulting in improved efficacy and IP protection [4] - Both CYB003 and CYB004 are designed to be adjunctive treatments, allowing for more efficient and cost-effective trials compared to competitors, and demonstrating greater efficacy with less frequent dosing [4] Market Positioning - Cybin's current market capitalization and enterprise value are significantly lower than those of leading competitors, despite favorable revenue and EBITDA projections for 2029 [5] - The company is well-capitalized relative to its peers, positioning it advantageously for future growth [5]

Core Insights - Cybin is focused on transforming the treatment of mental health disorders, particularly depression and anxiety, through modified synthetic tryptamines, specifically CYB003 and a deuterated version of DMT [2][3] - CYB003 has shown promising Phase 2 results, with 75% of patients responding to treatment and 100% of responders achieving remission after just two doses [3][2] - The company is preparing to initiate Phase 3 trials for CYB003, having received breakthrough therapy designation from the FDA, which underscores its potential efficacy [2][3] Company Overview - Cybin is a publicly traded mental health company aiming to change how mental health disorders are treated, moving beyond traditional symptom management to potentially altering the disease course [2] - The company has two assets in advanced clinical trials: CYB003 for major depressive disorder and a deuterated DMT for generalized anxiety disorder [2][3] Clinical Trial Results - In the Phase 2 study of CYB003, patients experienced a 22-point drop in depression scores after two doses, compared to an average decrease of 2 points with traditional SSRIs [3][2] - The company has followed up with patients for four months post-treatment, maintaining a 75% remission rate, which is unprecedented in the field [3][2] Regulatory and Market Position - CYB003 has been granted breakthrough therapy designation by the FDA, allowing for closer consultation and guidance during the Phase 3 trial design [3][2] - The company has a robust intellectual property portfolio with 70 patents granted and over 220 pending, which is critical for securing funding and ensuring a return on investment [2][3] Commercialization Strategy - Cybin plans to leverage existing infrastructure in outpatient clinics that currently offer treatments like esketamine, which could facilitate the adoption of CYB003 [3][2] - The company anticipates that CYB003 will require fewer patient visits compared to esketamine, potentially increasing access and scalability for treatment centers [3][2] Financial Health - Cybin has a strong balance sheet, having raised significant capital recently, which will support its Phase 3 trials and upcoming data readouts [3][2] - The company is currently trading at a market cap significantly lower than its peers, presenting a potential investment opportunity [4][2]

Acquisition and Intellectual Property - Cybin completed the acquisition of Small Pharma, making it a wholly-owned subsidiary, enhancing its portfolio in psychedelic-assisted therapies for mental health conditions [20]. - The company has over 70 granted patents and over 220 pending applications following the acquisition of Small Pharma, indicating a strong intellectual property position [21]. - The company holds a total of fifteen granted US patents and fifty-seven granted national (non-US) patents, supporting its research and development programs [106]. - The company has a total of nine provisional patent applications and one hundred sixty-eight national (non-US) patent applications pending, indicating ongoing innovation efforts [110]. - The company has a total of twenty-nine US non-provisional patent applications pending, reflecting its commitment to expanding its intellectual property portfolio [110]. - The company is focused on developing therapeutic compositions and methods related to deuterated compounds, as evidenced by multiple pending patent applications [111]. - The company has multiple pending patent applications related to Psilocybin and Tryptamine derivatives, indicating a strong focus on innovative therapeutic solutions [113][115][117]. - The company has filed multiple patent applications for combination drug therapies and formulations of psilocybin analogs across various jurisdictions, all currently pending [118]. - The patent applications cover novel psychedelic compounds with targeted structural modifications aimed at improving pharmacokinetic characteristics and safety profiles [122]. - The company is actively pursuing international patent protection across jurisdictions such as the United States, Europe, and Asia, which may enhance its market reach and competitive advantage [113][115][117]. Research and Development Strategy - Cybin's research and development strategy focuses on three pillars: preclinical innovation, clinical development, and the creation of intellectual property, supporting the development of compounds like CYB003 and CYB004 [19]. - The company aims to address the unmet need for innovative treatment options for mental health conditions, leveraging partnerships with world-class scientists [19]. - The company is focused on improving pharmacokinetics of its proprietary molecules while retaining therapeutic benefits through new technologies and delivery systems [13]. - The Company is developing psychedelic therapeutics targeting major depressive disorder (MDD), alcohol use disorder (AUD), and generalized anxiety disorder (GAD) among other mental health conditions [23]. - The Company has spent approximately $3,375 on the Deuterated Psilocybin Analog Program during the three months ended June 30, 2024 [45]. - The Company anticipates spending approximately $900 to complete preclinical development of a phenethylamine drug candidate by 2024, with a remaining spend of approximately $35 as of June 30, 2024 [72]. - The anticipated completion of preclinical development for the phenethylamine drug candidate has been updated to Q4 2024, delayed from Q3 2023 due to prioritization of the CYB003 Program [73]. - The company is exploring the potential of psilocybin and other psychedelics for therapeutic use, with a focus on their pharmacological effects [155]. - The company has commenced research on synthetic psilocybin delivery mechanisms, including sublingual film, IV, and inhalation [156]. Clinical Development and Trials - Cybin's clinical development programs include a deuterated psilocybin analog (CYB003) and a deuterated version of DMT (CYB004), which are in various stages of development [19]. - The lead program, CYB003, has received Breakthrough Therapy Designation (BTD) from the FDA, which may expedite its development timeline [29]. - In the Phase 2a study of CYB003, a statistically significant reduction in MDD symptoms was observed, with an average reduction of 14.08 points in the MADRS score compared to placebo (p=0.0005) [43]. - Following two doses of CYB003 (12mg), 79% of patients were in remission from depression at 6 weeks, demonstrating a favorable safety profile with no serious adverse events reported [44]. - The Company plans to initiate a Phase 3 study of CYB003 in late summer 2024 to further evaluate its efficacy in a larger MDD patient population [46]. - The Phase 3 CYB003 study will include thirty sites in the United States and Europe, with enrollment expected to commence shortly [49]. - The Phase 2 study of CYB004 in GAD is expected to provide topline safety and efficacy data around year-end 2024 or early Q1 2025 [67]. - The Company has partnered with Clinilabs to conduct the Phase 1/2a clinical trial of CYB003, its proprietary deuterated psilocybin analog [94]. - The Company is co-sponsoring a clinical trial with the University of Washington for psychedelic-assisted psychotherapy using psilocybin for frontline clinicians experiencing Covid-related distress [24]. Financial Position and Funding - The company anticipates significant fluctuations in losses due to external risk factors and ongoing funding requirements [9]. - The Company expects to spend approximately $13,276 to initiate a Phase 3 study of CYB003 in MDD, with a remaining spend of approximately $7,987 as of June 30, 2024 [48]. - The Company has a negative cash flow from operating activities and may need to raise additional funds through equity issuance or partnerships to cover future cash flow deficits [88]. - The company has negative cash flow from operating activities and has historically incurred net losses, indicating a need for additional funding through equity securities or partnerships [105]. - The company is required to raise additional funds to cover negative cash flows, with no assurance that favorable financing will be available [105]. - The Company has allocated $10,018,000 for the period from July 1, 2023, to June 30, 2024, with actual spending matching this amount [81]. Regulatory Environment - The company emphasizes the importance of regulatory approvals and successful clinical trials for its product candidates, which are at early stages of development [9]. - The company cannot guarantee timely approvals for its drug candidates due to the complex regulatory environment and potential scheduling issues with the DEA [165]. - The company is subject to ongoing regulation by the FDA, including requirements for recordkeeping, reporting, and compliance with Good Manufacturing Practices (GMP) [170]. - The company’s research and development must comply with regulations from federal, state, and local agencies in Canada, the U.S., and the UK [156]. - The regulatory process for marketing a prescription drug in the U.S. involves extensive non-clinical tests, submission of an IND application, and approval of a New Drug Application (NDA) by the FDA [164]. - The company must comply with the Dutch Medicines Act, which requires a marketing authorization before placing medicinal products on the market [193]. - The Centralized procedure for marketing authorization is compulsory for medicines intended to treat serious conditions such as cancer and diabetes [193]. - The DEA establishes annual aggregate quotas for the amount of controlled substances that may be manufactured in the U.S. based on legitimate needs [181]. - The EMA continuously monitors the safety of medicines post-authorization, including assessing reports from the marketing authorization holder [197]. Strategic Partnerships and Collaborations - The Company aims to establish strategic partnerships to advance its scientific research and intellectual property for new psychedelic-based compounds [23]. - The Company has established a collaboration with Greenbrook TMS to facilitate research and development of psychedelic therapeutics for depression [93]. - The Company has entered into an agreement with Mindset Pharma Inc. involving an initial license fee of $500 and potential milestone payments up to $9,500 [96]. - The Company has partnered with Worldwide Clinical Trials to manage clinical trials for mental health conditions, including major depressive disorder (MDD) [98]. - The Company plans to sponsor and work with licensed third parties to conduct clinical trials and research, rather than handling controlled substances directly [132]. Innovation and Technology - The Company completed proof-of-concept testing for its Digital Therapy Platform in Q2 2022 and is currently evaluating paths forward for the program [73]. - The feasibility study using Kernel Flow technology demonstrated ketamine's effects on cerebral cortex hemodynamics, confirming its ability to measure neuro-effects over 10 days [75]. - The Phase 1 Kernel Flow feasibility study involved 15 participants, with ketamine administered at a target dose of 0.75 mg/kg, and results indicated persistent changes in functional connectivity for several days post-administration [79]. - The ongoing development of integrated data collection devices for therapeutic applications suggests a commitment to leveraging technology in enhancing treatment outcomes [113]. Market Position and Future Outlook - The company has not entered into commercial supply agreements and assumes it will do so when market competition allows for reasonable pricing [101]. - There are no significant events or milestones expected in the next 12 months that could impact the company's business objectives [104]. - The company may need to reallocate its capital resources based on project results, which could affect its business objectives [104]. - The company is exploring new formulations of Psilocybin, which may lead to novel treatment options in the wellness and therapeutic sectors [117]. - The emphasis on companion animal treatments highlights the company's diversification strategy into veterinary medicine, potentially opening new revenue streams [113].

Core Insights - The article discusses potential investment opportunities in biotech stocks, particularly focusing on companies like Structure Therapeutics (GPCR), Cybin (CYBN), Eli Lilly (LLY), and Syndax Pharma (SNDX) based on upcoming FDA decisions and trial results [2][4][22]. Group 1: Structure Therapeutics (GPCR) - GPCR is expected to report Phase 2a 12-week obesity drug data in Q2, with positive Phase 1 results raising expectations for solid Phase 2 outcomes [2]. - The stock price of GPCR was approximately $36.80 prior to the anticipated data release, which is expected on June 3 [2]. - Following the release of positive top-line Phase 2a data, the stock reached a high of $62.74, indicating significant potential for profit through anticipation trading [15]. Group 2: Cybin (CYBN) - The FDA is set to decide on the approval of MDMA-assisted therapy for PTSD on August 11, which could positively impact psychedelic stocks like Cybin [4][9]. - A recent study indicated that MDMA reduced PTSD symptoms in 86% of participants after 18 weeks, although an FDA panel voted against approval due to concerns about trial execution [8][9]. Group 3: Eli Lilly (LLY) - Eli Lilly's Zepbound drug is under consideration for the treatment of obstructive sleep apnea, with an FDA decision expected before the end of the year [19]. - The company anticipates that FDA approval could benefit the 80 million Americans suffering from obstructive sleep apnea, and the stock is currently viewed as oversold [18][19]. Group 4: Syndax Pharma (SNDX) - The FDA will decide on Syndax Pharma's axatilimab for chronic graft-versus-host disease (GVHD) on August 28, following two previous systemic therapy failures [21]. - Analysts from Jefferies and Stifel have initiated Buy ratings on SNDX, with price targets of $37 and $42 respectively, citing the company's potential for commercialization [22].

Core Insights - Cybin Inc. is positioned as a leader in developing next-generation psychedelic-based therapeutics, focusing on major depressive disorder (MDD) and generalized anxiety disorder (GAD) [1][2] - The company has made significant advancements in fiscal 2024, supported by innovative research programs and strong financial health [1][12] - Cybin's proprietary compounds, CYB003 and CYB004, are in advanced clinical stages, with CYB003 receiving Breakthrough Therapy Designation from the FDA [8][10] Financial Performance - As of March 31, 2024, Cybin reported cash reserves of C$209 million (approximately USD$153 million) [12] - The company has access to over C$285 million (about USD$208 million) to support its clinical programs and operational initiatives [12][13] - Zacks Investment Research upgraded Cybin to a Zacks Rank 2 (Buy), indicating a positive outlook based on earnings estimates [6][15] Clinical Developments - Cybin is preparing to launch a Phase 3 multinational study of CYB003 in summer 2024, which aims to evaluate its safety and efficacy in a larger MDD patient population [9][20] - The Phase 2 study of CYB003 showed a mean reduction of 14 points in the MADRS score, indicating significant improvement in depressive symptoms [16] - CYB004 is advancing to a Phase 2 study targeting GAD, with the FDA clearing its Investigational New Drug application [10][17] Insider Confidence - Recent insider transactions indicate strong confidence from executives and directors in Cybin's strategic direction, with substantial stock purchases made by senior officers [4][5] - Notable purchases include 200,000 shares by CEO Douglas Drysdale and other significant acquisitions by senior officers [4] Intellectual Property - Cybin has a robust intellectual property portfolio with over 60 granted patents and more than 200 pending applications, ensuring exclusivity for its treatment candidates until at least 2041 [11]

Core Viewpoint - Cybin Inc. (CYBN) has been upgraded to a Zacks Rank 2 (Buy) due to an upward trend in earnings estimates, which is a significant factor influencing stock prices [3][5]. Earnings Estimates and Stock Movement - The Zacks rating system is based on changes in earnings estimates, which are strongly correlated with near-term stock price movements [4][6]. - An increase in earnings estimates typically leads to higher fair value calculations by institutional investors, resulting in buying or selling pressure that affects stock prices [6]. Cybin Inc. Specifics - For the fiscal year ending March 2025, Cybin Inc. is expected to earn -$0.09 per share, reflecting a 52.6% change from the previous year's reported number [10]. - Over the past three months, the Zacks Consensus Estimate for Cybin Inc. has increased by 15%, indicating positive sentiment among analysts [10]. Zacks Rating System - The Zacks Rank system classifies stocks into five groups based on earnings estimates, with only the top 20% of stocks receiving a 'Strong Buy' or 'Buy' rating [11][13]. - Stocks rated Zacks Rank 1 (Strong Buy) have historically generated an average annual return of +25% since 1988, showcasing the effectiveness of the rating system [9].