Cybin(CYBN)

Search documents
Cybin(CYBN) - 2024 Q1 - Quarterly Report
2024-08-08 17:42
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].
3 Biotech Stocks That Could Make Your Summer Unforgettable
Investor Place· 2024-07-30 19:07
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].
A Swell Of Insider Purchases Follow Cybin Inc.'s Positive Year-End Update
Newsfile· 2024-07-08 12:38
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]
What Makes Cybin Inc. (CYBN) a New Buy Stock
ZACKS· 2024-06-27 17:00
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].
Down -17.45% in 4 Weeks, Here's Why Cybin Inc. (CYBN) Looks Ripe for a Turnaround
ZACKS· 2024-06-11 14:35
Core Viewpoint - Cybin Inc. (CYBN) is experiencing a significant downtrend with a 17.5% decline over the past four weeks, but it is now considered oversold, indicating a potential for a price rebound due to strong analyst support for improved earnings estimates [2][3]. Group 1: Technical Indicators - The Relative Strength Index (RSI) for CYBN is currently at 20.85, suggesting that the heavy selling pressure may be exhausting, which could lead to a price bounce back [5]. - A stock is typically deemed oversold when its RSI falls below 30, indicating a potential reversal point [5]. Group 2: Analyst Sentiment - There has been a strong consensus among sell-side analysts regarding CYBN's ability to report better earnings, leading to a 5.6% increase in the consensus EPS estimate over the last 30 days [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 [2].
Numinus and Cybin Embark on a Groundbreaking Journey: Pioneering Phase 3 Trials for Major Depressive Disorder
Newsfile· 2024-05-30 13:08
● . ● Numinus and Cybin Embark on a Groundbreaking Journey: Pioneering Phase 3 Trials for Major Depressive Disorder May 30, 2024 9:08 AM EDT | Source: Numinus Wellness Inc. Vancouver, British Columbia--(Newsfile Corp. - May 30, 2024) - In a significant stride towards transforming mental health care, Numinus Wellness Inc. (TSX: NUMI) (OTCQX: NUMIF) (FSE: LR23) has proudly announced that its research site, Cedar Clinical Research (CCR), has been selected for Cybin's Phase 3 pivotal multinational clinical tria ...
Cybin (CYBN) Begins Phase II Study on Anxiety Drug, Stock Up
Zacks Investment Research· 2024-03-18 16:26
Cybin Inc.’s (CYBN) shares were up 7.2% on Mar 15 after the company initiated a phase II proof-of-concept study evaluating its proprietary deuterated dimethyltryptamine molecule, CYB004, for the treatment of patients with generalized anxiety disorder (GAD).Per the company, the double-blind phase II CYB004-002 study will investigate the safety and efficacy of CYB004 in the given patient population. Patients will be divided into two groups. The first group of patients will receive two IM doses of CYB004, whil ...
Cybin to Present at Public Ventures Discovery Day on March 19th in Dallas
Businesswire· 2024-03-18 11:30
TORONTO--(BUSINESS WIRE)--Cybin Inc. (NYSE American:CYBN) (Cboe CA:CYBN) (“Cybin” or the “Company”), a clinical-stage biopharmaceutical company committed to revolutionizing mental healthcare by developing new and innovative next-generation psychedelic-based treatment options, today announced participation in the upcoming Public Ventures Discovery Day on March 19, 2024 in Dallas, TX. Doug Drysdale, Chief Executive Officer of Cybin will participate in a fireside chat at the event and will be available to mee ...
Cybin Initiates Phase 2 Proof-of-Concept Study of CYB004 in Generalized Anxiety Disorder
Businesswire· 2024-03-15 11:30
TORONTO--(BUSINESS WIRE)--Cybin Inc. (NYSE American:CYBN) (Cboe CA:CYBN) (“Cybin” or the “Company”), a clinical-stage biopharmaceutical company committed to revolutionizing mental healthcare by developing new and innovative next-generation psychedelic-based treatment options, today announced the initiation of a Phase 2 proof-of-concept study of CYB004, its proprietary DMT molecule in development for the treatment of GAD. In January 2024, the U.S. Food and Drug Administration (“FDA”) cleared Cybin’s Investig ...
Cybin Announces Positive End-of-Phase 2 Meeting with FDA for CYB003 in Major Depressive Disorder and Phase 3 Program Design
Businesswire· 2024-03-14 11:30
TORONTO--(BUSINESS WIRE)--Cybin Inc. (NYSE American:CYBN) (Cboe CA:CYBN) (“Cybin” or the “Company”), a clinical-stage biopharmaceutical company committed to revolutionizing mental healthcare by developing new and innovative next-generation psychedelic-based treatment options, today announced a positive End-of-Phase 2 meeting with the FDA for CYB003, its deuterated psilocybin analog for the adjunctive treatment of Major Depressive Disorder (“MDD”). This program will be the first ever adjunctive Phase 3 deut ...