Neo Bio Co., Ltd.

- Marks first ever trial to evaluate deuterated DMT in humans – - Based on preclinical studies CYB004 demonstrated superior bioavailability compared to IV DMT which may support less invasive dosing methods - - CYB004 is a patented proprietary molecule protected through 2041 - TORONTO--(BUSINESS WIRE)-- Cybin Inc. (NEO:CYBN) (NYSE AMERICAN:CYBN) (“Cybin” or the “Company”), a biopharmaceutical company focused on progressing Psychedelics to Therapeutics® is pleased to announce that it has received approval from an independent ethics committee in the Netherlands to initiate first-in-human dosing of its proprietary deuterated N,N-dimethyltryptamine (“DMT”) molecule CYB004 through a protocol amendment to its ongoing CYB004-E Phase 1 trial. This clinical advancement marks the first time a deuterated DMT molecule will be evaluated in humans and further reduces Cybin’s time-to-clinic with CYB004. The Phase 1 CYB004-E trial is being conducted at the Centre for Human Drug Research in the Netherlands and is the largest ever Phase 1 DMT trial conducted to-date. In its regular form, DMT is an unstable molecule rapidly metabolized in the body, which significantly reduces its bioavailability. CYB004 has the potential to overcome the limitations of DMT. Based on preclinical studies, CYB004 has demonstrated an improved bioavailability and pharmacokinetic pro comparison to DMT when administered via intravenous (“IV”) and inhaled routes. These studies also demonstrated that IV CYB004 has a longer duration of effect compared to DMT, indicating the potential to extend the therapeutic window and provide better dose optimization. By maximizing CYB004 as a deuterated molecule and improving upon the bioavailability of DMT, CYB004 has the potential to offer more convenient dosing methods via inhaled, subcutaneous, or intramuscular routes of administration. “This is a major milestone for our CYB004 program and for better understanding the potential therapeutic benefits of our proprietary deuterated DMT molecule for the treatment of generalized anxiety disorder,” said Doug Drysdale, Cybin’s Chief Executive Officer. “The ability to evaluate our novel CYB004 molecule in humans at this early stage is a significant achievement in clinical development and will provide important insight into the pharmacokinetic and pharmacodynamic properties of CYB004 in addition to what we have already learned through our study of DMT. We expect to apply these findings to optimize dosing and delivery of CYB004 in future clinical trials, which supports our mission to bring this new investigational therapy to patients as quickly as possible.” Cybin secured a U.S. composition of matter patent covering CYB004 in February 2022 that provides patent protection through 2041. The patent covers a range of deuterated forms of DMT and protects CYB004 as a putative new chemical entity. “With strong intellectual property in place and promising preclinical data, we believe we have a solid clinical development path forward for CYB004. We will continue to focus our research on identifying the most convenient routes of administration while also maintaining an optimal therapeutic pro this important molecule,” concluded Drysdale. The Company plans to evaluate CYB004 for the treatment of generalized anxiety disorder with or without major depressive disorder. Cybin will provide additional information on its CYB004 program, including an update on the Phase 1 CYB004-E trial, at its upcoming virtual R&D Day on February 28, 2023. Click here to register for the event. About Cybin Cybin is a leading ethical biopharmaceutical company, working with a network of world-class partners and internationally recognized scientists, on a mission to create safe and effective therapeutics for patients to address a multitude of mental health issues. Headquartered in Canada and founded in 2019, Cybin is operational in Canada, the United States, the United Kingdom, the Netherlands and Ireland. The Company is focused on progressing Psychedelics to Therapeutics by engineering proprietary drug discovery platforms, innovative drug delivery systems, novel formulation approaches and treatment regimens for mental health disorders. Cautionary Notes and Forward-Looking Statements Certain statements in this press release constitute forward-looking information. All statements other than statements of historical fact contained in this press release, including, without limitation, statements regarding Cybin’s future, strategy, plans, objectives, goals and targets, and any statements preceded by, followed by or that include the words “believe”, “expect”, “aim”, “intend”, “plan”, “continue”, “will”, “may”, “would”, “anticipate”, “estimate”, “forecast”, “predict”, “project”, “seek”, “should” or similar expressions or the negative thereof, are forward-looking statements. Forward looking statements in this news release include statements related to the results of the Company’s CYB004 pre-clinical studies, statements regarding the Company’s expectations and objectives regarding the results of the CYB004-E study, and the Company’s proprietary drug discovery platforms, innovative drug delivery systems, novel formulation approaches and treatment regimens to potentially treat generalized anxiety disorder with or without major depressive disorder and/or other psychiatric disorders. These forward-looking statements are based on reasonable assumptions and estimates of management of the Company at the time such statements were made. Actual future results may differ materially as forward-looking statements involve known and unknown risks, uncertainties, and other factors which may cause the actual results, performance, or achievements of the Company to materially differ from any future results, performance, or achievements expressed or implied by such forward-looking statements. Such factors, among other things, include: implications of the COVID-19 pandemic on the Company's operations; fluctuations in general macroeconomic conditions; fluctuations in securities markets; expectations regarding the size of the psychedelics market; the ability of the Company to successfully achieve its business objectives; plans for growth; political, social and environmental uncertainties; employee relations; the presence of laws and regulations that may impose restrictions in the markets where the Company operates; and the risk factors set out in the Company's management's discussion and analysis for the three and six month periods ended September 30, 2022 and the Company's annual information form for the year ended March 31, 2022, which are available under the Company's pro and with the U.S. Securities and Exchange Commission on EDGAR at . Although the forward-looking statements contained in this news release are based upon what management of the Company believes, or believed at the time, to be reasonable assumptions, the Company cannot assure shareholders that actual results will be consistent with such forward-looking statements, as there may be other factors that cause results not to be as anticipated, estimated or intended. Readers should not place undue reliance on the forward-looking statements and information contained in this news release. The Company assumes no obligation to update the forward-looking statements of beliefs, opinions, projections, or other factors, should they change, except as required by law. Cybin makes no medical, treatment or health benefit claims about Cybin’s proposed products. The U.S. Food and Drug Administration, Health Canada or other similar regulatory authorities have not evaluated claims regarding psilocybin, psychedelic tryptamine, tryptamine derivatives or other psychedelic compounds or nutraceutical products. The efficacy of such products has not been confirmed by approved research. There is no assurance that the use of psilocybin, psychedelic tryptamine, tryptamine derivatives or other psychedelic compounds or nutraceuticals can diagnose, treat, cure or prevent any disease or condition. Vigorous scientific research and clinical trials are needed. Cybin has not conducted clinical trials for the use of its proposed products. Any references to quality, consistency, efficacy and safety of potential products do not imply that Cybin verified such in clinical trials or that Cybin will complete such trials. If Cybin cannot obtain the approvals or research necessary to commercialize its business, it may have a material adverse effect on Cybin’s performance and operations. Neither the Neo Exchange Inc. nor the NYSE American LLC stock exchange have approved nor disapproved the contents of this news release and are not responsible for the adequacy and accuracy of the contents herein.

TORONTO--(BUSINESS WIRE)-- Cybin Inc. (NEO:CYBN) (NYSE American: CYBN) (Cybin or the Company), a biopharmaceutical company focused on progressing Psychedelics to Therapeutics® today announced that it will host a virtual R&D Day on Tuesday, February 28, 2023, from 10:00 a.m. ET to 11:30 a.m. ET. The event, which will be hosted by Cybin’s leadership team, will provide a progress update on the Company’s development pipeline of differentiated psychedelic-based therapeutics, including CYB003 and CYB004. Specifically, the Company plans to provide an interim readout from the ongoing Phase 1/2a study evaluating CYB003, an update from the ongoing Phase 1 exploratory CYB004-E trial evaluating IV N,N-dimethyltryptamine and a review of its clinical development program evaluating CYB004. Cybin is evaluating CYB003 for the treatment of major depressive disorder and CYB004 is being evaluated for the treatment of generalized anxiety disorder. To participate in the event, please click here to register and access the live webcast. A Q&A session for the investment community will follow the prepared remarks. The archived webcast will also be available on the Company’s investor relations website on the Events & Presentations page following the event. About Cybin Cybin is a leading ethical biopharmaceutical company, working with a network of world-class partners and internationally recognized scientists, on a mission to create safe and effective therapeutics for patients to address a multitude of mental health issues. Headquartered in Canada and founded in 2019, Cybin is operational in Canada, the United States, the United Kingdom, the Netherlands and Ireland. The Company is focused on progressing Psychedelics to Therapeutics by engineering proprietary drug discovery platforms, innovative drug delivery systems, novel formulation approaches and treatment regimens for mental health disorders. Cautionary Notes and Forward-Looking Statements Certain statements in this press release constitute forward-looking information. All statements other than statements of historical fact contained in this press release, including, without limitation, statements regarding Cybin’s future, strategy, plans, objectives, goals and targets, and any statements preceded by, followed by or that include the words “believe”, “expect”, “aim”, “intend”, “plan”, “continue”, “will”, “may”, “would”, “anticipate”, “estimate”, “forecast”, “predict”, “project”, “seek”, “should” or similar expressions or the negative thereof, are forward-looking statements. Forward looking statements in this news release include statements regarding the Company’s plan to provide a progress update on the Company’s development pipeline, an interim readout from its Phase 1/2a study evaluating CYB003, an update on its Phase 1 exploratory CYB004-E trial, and a review of its clinical development program evaluating CYB004. These forward-looking statements are based on reasonable assumptions and estimates of management of the Company at the time such statements were made. Actual future results may differ materially as forward-looking statements involve known and unknown risks, uncertainties, and other factors which may cause the actual results, performance, or achievements of the Company to materially differ from any future results, performance, or achievements expressed or implied by such forward-looking statements. Such factors, among other things, include: implications of the COVID-19 pandemic on the Company's operations; fluctuations in general macroeconomic conditions; fluctuations in securities markets; expectations regarding the size of the psychedelics market; the ability of the Company to successfully achieve its business objectives; plans for growth; political, social and environmental uncertainties; employee relations; the presence of laws and regulations that may impose restrictions in the markets where the Company operates; and the risk factors set out in the Company's management's discussion and analysis for the three and six month periods ended September 30, 2022 and the Company's annual information form for the year ended March 31, 2022, which are available under the Company's pro and with the U.S. Securities and Exchange Commission on EDGAR at . Although the forward-looking statements contained in this news release are based upon what management of the Company believes, or believed at the time, to be reasonable assumptions, the Company cannot assure shareholders that actual results will be consistent with such forward-looking statements, as there may be other factors that cause results not to be as anticipated, estimated or intended. Readers should not place undue reliance on the forward-looking statements and information contained in this news release. The Company assumes no obligation to update the forward-looking statements of beliefs, opinions, projections, or other factors, should they change, except as required by law. Cybin makes no medical, treatment or health benefit claims about Cybin’s proposed products. The U.S. Food and Drug Administration, Health Canada or other similar regulatory authorities have not evaluated claims regarding psilocybin, psychedelic tryptamine, tryptamine derivatives or other psychedelic compounds or nutraceutical products. The efficacy of such products has not been confirmed by approved research. There is no assurance that the use of psilocybin, psychedelic tryptamine, tryptamine derivatives or other psychedelic compounds or nutraceuticals can diagnose, treat, cure or prevent any disease or condition. Vigorous scientific research and clinical trials are needed. Cybin has not conducted clinical trials for the use of its proposed products. Any references to quality, consistency, efficacy and safety of potential products do not imply that Cybin verified such in clinical trials or that Cybin will complete such trials. If Cybin cannot obtain the approvals or research necessary to commercialize its business, it may have a material adverse effect on Cybin’s performance and operations. Neither the Neo Exchange Inc. nor the NYSE American LLC stock exchange have approved nor disapproved the contents of this news release and are not responsible for the adequacy and accuracy of the contents herein.

- Study supports earlier findings and demonstrates that Kernel Flow provides a functional measure of blood oxygenation changes in the brain associated with neural activity - TORONTO--(BUSINESS WIRE)-- Cybin Inc. (NEO:CYBN) (NYSE American: CYBN) (Cybin or the Company), a biopharmaceutical company focused on progressing Psychedelics to Therapeutics® today announced key highlights from the completed feasibility study conducted by its partner HI, LLC dba Kernel (“Kernel”), evaluating Kernel’s Flow® wearable technology to measure ketamine's psychedelic effect on cerebral cortex hemodynamics. Results from this Cybin-sponsored study are intended to inform the future pathway for this program. “The results from the feasibility study are very promising and provide further insights into the potential of this cutting-edge wearable technology to quantify neural activity and changes in brain biomarkers during the administration of psychedelics. The possibility of using this technology to develop a predictive tool to aid in identifying appropriate candidates for psychedelic-based therapy is also quite exciting, as is the convenience of a portable device, which could lend itself to more widespread use in clinical settings,” said Doug Drysdale, Chief Executive Officer of Cybin. “Looking ahead, we remain focused on expanding our scientific understanding of the effects and mechanisms of action of psychedelics on the brain – all with the ultimate goal of developing safe and effective treatments for a range of mental health conditions,” concluded Drysdale. Key Findings from the Feasibility Study: Provided important proof-of-principle for Kernel Flow as a portable functional system that provides real-time measurements of blood oxygenation changes in the brain associated with neural activity using Time Domain Near Infrared Spectroscopy (“TD-fNIRS”). Demonstrated ketamine-induced changes to functional brain biomarkers associated with potential therapeutic effects, including alterations in cortical function associated with psychedelic experiences. Ketamine led to a brain-wide reduction in the fractional amplitude of low frequency fluctuations (“fALFF”) and a decrease in the global brain connectivity of the prefrontal region compared to saline. It has been suggested that fALFF is of particular functional importance within the default mode network, which has been shown to be modulated by psychedelics and is associated with a range of neuropsychiatric conditions. A model combining neural and physiological metrics successfully predicted mystical experience scores on Revised Mystical Experience Questionnaire, which has been shown in previous research to mediate reductions in depressive symptomatology. Demonstrated reliable physiological measurements of pulse rate (“PR”) and pulse rate variability (“PRV”) extracted from TD-fNIRS recordings that match those obtained from commercial external photoplethysmography sensors, thus rendering the use of external sensors to measure cardiac activity unnecessary in future experiments. Ketamine led to increased PR, decreased PRV, increased absolute concentrations of oxy-hemoglobin and decreased deoxy-hemoglobin concentrations, and elevated electrodermal activity (measured by an external sensor), providing further physiological measures of the effects of the ketamine doses administered in the study. “This study can be regarded as an important step toward larger-scale clinical studies using Kernel Flow to quantify the impact of psychedelics, or other neuroactive substances and central nervous system drugs, on the brain,” said Bryan Johnson, Founder and Chief Executive Officer of Kernel. “The feasibility study demonstrated the successful application of the portable Kernel Flow neuroimaging system to measure effects of the psychoactive substance ketamine on brain hemodynamics and provided preliminary evidence that a combination of neural and physiological metrics can track subjective mystical experiences.” Feasibility Study Design The study was a single-blind, placebo-controlled, non-randomized design with participants completing study visits roughly once a week for four weeks. The four study visits were always conducted in the same order: a screening visit, two dosing visits, and a follow-up phone call. Dosing visits were always placebo (saline, 0.9% NaCl) first and ketamine second, with the ketamine visit occurring one week (7.1±0.5 days, mean ±SD) after the saline visit. Ketamine and saline were administered via bolus intramuscular injection (deltoid muscle). Ketamine dosing was based on participant weight with a target of 0.75 mg/kg, up to the maximum dose of 60 mg. Two participants were administered the maximum dose. Participants included 15 healthy individuals who met eligibility criteria and consented to participation in the study. There were eight females and seven males, all 24-48 years old. The main objective of the feasibility study was to evaluate a participant’s experience wearing Kernel Flow while in an altered state of consciousness following the administration of ketamine. The feasibility study received U.S. Food and Drug Administration Investigational New Drug authorization in October 2021 and U.S. Institutional Review Board approval in January 2022. As part of Cybin’s sponsorship of the feasibility study, the Company will retain an exclusive interest in any innovations that are discovered or developed through its independent analysis of the study findings. About Kernel Flow® Kernel Flow is a wearable headset that measures brain activity by recording local changes in blood oxygenation. It is adjustable, can accommodate nearly anyone and is safe. Kernel Flow is a groundbreaking neurotechnology because it reduces loud, expensive, and room-sized equipment to a head-worn apparatus while providing neural activity data of the highest possible optical quality. This combination has never existed in such a commercial and scalable device, all factors for why brain interfaces and neuroimaging technology has largely remained in academic labs or hospital basements. The entire system is the size and look of a bicycle helmet and could, in the future, be more broadly used for neuroscientific or physiological studies of brain activity during treatment. About Cybin Cybin is a leading ethical biopharmaceutical company, working with a network of world-class partners and internationally recognized scientists, on a mission to create safe and effective therapeutics for patients to address a multitude of mental health issues. Headquartered in Canada and founded in 2019, Cybin is operational in Canada, the United States, the United Kingdom, the Netherlands and Ireland. The Company is focused on progressing Psychedelics to Therapeutics by engineering proprietary drug discovery platforms, innovative drug delivery systems, novel formulation approaches and treatment regimens for mental health disorders. Cautionary Notes and Forward-Looking Statements Certain statements in this press release constitute forward-looking information. All statements other than statements of historical fact contained in this press release, including, without limitation, statements regarding Cybin’s future, strategy, plans, objectives, goals and targets, and any statements preceded by, followed by or that include the words “believe”, “expect”, “aim”, “intend”, “plan”, “continue”, “will”, “may”, “would”, “anticipate”, “estimate”, “forecast”, “predict”, “project”, “seek”, “should” or similar expressions or the negative thereof, are forward-looking statements. Forward looking statements in this news release include statements regarding the anticipated results and potential uses of the Kernel Flow technology, the ability of Kernel Flow to potentially assist in and/or serve as a tool in respect of the identification and development of treatment regimens, the Company’s plan to engineer proprietary drug development platforms, innovative drug delivery systems, novel formulation approaches, potential treatment regimens for psychiatric disorders and development of medicinal psychedelics to address unmet medical needs. These forward-looking statements are based on reasonable assumptions and estimates of management of the Company at the time such statements were made. Actual future results may differ materially as forward-looking statements involve known and unknown risks, uncertainties, and other factors which may cause the actual results, performance, or achievements of the Company to materially differ from any future results, performance, or achievements expressed or implied by such forward-looking statements. Such factors, among other things, include: implications of the COVID-19 pandemic on the Company's operations; fluctuations in general macroeconomic conditions; fluctuations in securities markets; expectations regarding the size of the psychedelics market; the ability of the Company to successfully achieve its business objectives; plans for growth; political, social and environmental uncertainties; employee relations; the presence of laws and regulations that may impose restrictions in the markets where the Company operates; and the risk factors set out in the Company's management's discussion and analysis for the three and six month periods ended September 30, 2022 and the Company's annual information form for the year ended March 31, 2022, which are available under the Company's pro and with the U.S. Securities and Exchange Commission on EDGAR at . Although the forward-looking statements contained in this news release are based upon what management of the Company believes, or believed at the time, to be reasonable assumptions, the Company cannot assure shareholders that actual results will be consistent with such forward-looking statements, as there may be other factors that cause results not to be as anticipated, estimated or intended. Readers should not place undue reliance on the forward-looking statements and information contained in this news release. The Company assumes no obligation to update the forward-looking statements of beliefs, opinions, projections, or other factors, should they change, except as required by law. Cybin makes no medical, treatment or health benefit claims about Cybin’s proposed products. The U.S. Food and Drug Administration, Health Canada or other similar regulatory authorities have not evaluated claims regarding psilocybin, psychedelic tryptamine, tryptamine derivatives or other psychedelic compounds or nutraceutical products. The efficacy of such products has not been confirmed by approved research. There is no assurance that the use of psilocybin, psychedelic tryptamine, tryptamine derivatives or other psychedelic compounds or nutraceuticals can diagnose, treat, cure or prevent any disease or condition. Vigorous scientific research and clinical trials are needed. Cybin has not conducted clinical trials for the use of its proposed products. Any references to quality, consistency, efficacy and safety of potential products do not imply that Cybin verified such in clinical trials or that Cybin will complete such trials. If Cybin cannot obtain the approvals or research necessary to commercialize its business, it may have a material adverse effect on Cybin’s performance and operations. Neither the Neo Exchange Inc. nor the NYSE American LLC stock exchange have approved nor disapproved the contents of this news release and are not responsible for the adequacy and accuracy of the contents herein.