Clene Reports Significant Decreased Mortality in RESCUE-ALS Long-Term Open-Label Extension Trial

“Clinilabs is honored to work with Cybin, an innovator in the development of new psychedelic therapies, to conduct its first-in-human clinical trial of CYB003,” said Jeanine Falinski, Vice President of Strategy and Corporate Development. at Clinilabs. “We are excited about the potential of these therapies and hope the future will change the lives of people with mental illness. We are encouraged by the interest of potential research participants who have already shown up before today.

“Successful patient recruitment and an appropriate clinical environment are integral to this trial. As a global leader in drug development services, Clinilabs is an ideal partner and we are grateful for their support and guidance,” said Doug Drysdale, CEO of Cybin. .

About the CYB003 Phase 1/2a trial

The Phase 1/2a trial is a randomized, double-blind, placebo-controlled study evaluating people with moderate to severe MDD. Participants will receive two administrations of study drug and response/remission will be assessed at week 3 (after the first dose) and week 6 (after the second dose). It is important to note that trial participants who are currently being treated with selective serotonin reuptake inhibitors will be allowed to continue taking their antidepressants.

Using the Montgomery-Asberg Depression Rating Scale, the trial will assess the rapid onset of antidepressant effect on the day of administration. The study will also assess the incremental benefit of a second dose of CYB003 when given at week 3 and provide important pharmacokinetic and safety data to determine a clinical pathway forward. An optional evaluation period will help determine the durability of the treatment effect for up to 12 weeks. The detailed protocol of the phase 1/2a study is available on clinicaltrials.gov under the identification number: NCT05385783.

This research study is recruiting people between the ages of 21 and 55 who have been diagnosed with MDD and are currently taking an SSRI or SNRI that is not working to their satisfaction. Participation includes 11 outpatient visits and two 2-day hospital stays. Compensation can be up to $4,335 including travel. Participants who are within a reasonable distance of the Clinilabs Eatontown, New Jersey Clinical Research Unit can pre-screen study entry at www.depressionpsychedelicstudy.com or by phone at (212) 994-4567.

About CYB003

CYB003 is a deuterated psilocybin analog, part of a family of molecules called indolamines that include more common neurotransmitters, like serotonin. Psilocybin is dephosphorylated to form its metabolite psilocin, which can cross the blood-brain barrier. Given its structural similarity to serotonin, CYB003 can easily activate the serotonin 5-HT2A receptor.

CYB003 is designed to potentially address the challenges and limitations of oral psilocybin. Based on preclinical data, CYB003 achieved less variability in plasma concentrations, faster onset of action and shorter duration of effect. We believe CYB003 has the potential to reduce the burden of time and resources on patients, providers, and payers, and possibly improve treatment scalability and accessibility.

About Clinilabs Drug Development Corporation

Clinilabs Drug Development Corporation is the only global, full-service contract research organization (CRO) focused exclusively on central nervous system (“CNS”) drug development. With deep CNS expertise, we engage in the development of medicines that treat a range of psychiatric, neurological and substance use disorders, as well as rare and ultra-rare CNS diseases. Clinilabs partners with pharmaceutical and biotechnology companies to provide a full range of first-in-man to Phase 3, high-quality, timely and cost-effective clinical drug development services with the common goal of accelerating on the market for new drugs for the CNS. We are process driven but structured to be agile, delivering a personalized service that meets the needs of clients and projects of all sizes. Clinilabs has conducted more than 675 CNS clinical trials over our 22-year history and played a pivotal role in approving 19 new therapies in 10 CNS indications to help transform the lives of patients around the world. entire.

About Cybin

Cybin is a leading ethical biopharmaceutical company, working with a network of world-class partners and internationally recognized scientists, to create safe and effective therapies for patients to treat a multitude of mental health conditions. Based in Canada and founded in 2019, Cybin is operational in Canada, United States, United Kingdom, Netherlands and Ireland. The Company is focused on advancing psychedelics into therapeutics by designing 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 contained in this press release constitute forward-looking information. All statements other than statements of historical facts contained in this press release, including, without limitation, statements regarding Cybin’s future, strategy, plans, objectives, goals and targets, and all statements preceded by, followed by, or containing the words “believe”, “expect”, “aim”, “intend”, “plan”, “continue”, “will”, “may”, “could”, “anticipate”, “estimate”, “anticipate”, “predict”, “plan”, “seek”, “should” or similar expressions or negatives thereof, are forward-looking statements. Forward-looking statements in this press release include statements regarding the results of the Company’s CYB003 preclinical studies, statements regarding the Company’s Phase 1/2a CYB003 trial and expected results, the Company’s plans to begin to enroll patients immediately for its Phase 1/2a CYB003 trial and the company’s plan to design proprietary drug discovery platforms, innovative drug delivery systems, novel formulation approaches and therapeutic regimens for mental health disorders.

These forward-looking statements are based on reasonable assumptions and estimates made by the management of the Company at the time such statements were made. Actual future results may differ materially because forward-looking statements involve known and unknown risks, uncertainties and other factors that may cause the actual results, performance or achievements of the Company to differ materially from the results, performance or achievements future expressed or implied by such forward-looking statements. These factors include, among others: the implications of the COVID-19 pandemic on the Company’s operations; fluctuations in general macroeconomic conditions; fluctuations in the securities markets; expectations regarding the size of the psychedelic market; the Company’s ability to successfully achieve its business objectives; growth plans; political, social and environmental uncertainties; employee relations; the presence of laws and regulations that may impose restrictions on the markets in which the Company operates; and the risk factors set forth in the Company’s MD&A for the fiscal year ended March 31, 2022 and the Company’s Annual Information Form for the fiscal year ended March 31, 2022, which are available under the Company’s profile on www.sedar.com and with the United States Securities and Exchange Commission on EDGAR at www.sec.gov. Although the forward-looking statements contained in this press release are based on 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 statements. 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 press release. The Company undertakes no obligation to update any 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 regarding the products offered by Cybin. The United States 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. The effectiveness of these products has not been confirmed by approved research. There is no guarantee that the use of psilocybin, psychedelic tryptamine, tryptamine derivatives, or other psychedelic compounds will diagnose, treat, cure, or prevent any disease or condition. Rigorous scientific research and clinical trials are needed. Cybin has not conducted clinical trials for the use of the products offered. Any reference to the quality, consistency, efficacy and safety of potential products does not imply that Cybin has verified it in clinical trials or that Cybin will complete such trials. Failure by Cybin to obtain the necessary approvals or research to commercialize its business could have a material adverse effect on Cybin’s performance and operations.

Neither Neo Exchange Inc. nor NYSE American LLC has approved or disapproved of the content of this press release and is not responsible for the adequacy and accuracy of the content.

Investor and media contacts:

Jeanine M. Falinski, MBA
Vice President, Strategy and Corporate Development
Clinilabs drug development company
[email protected]

Lea Gibson
Vice President, Investor Relations and Strategic Communications
Cybin Inc.
[email protected] – or – [email protected]

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