CYB-003

Calling results from a handful of patients who received synthetic psilocybin analogue CYB003 for major depressive disorder (MDD) "remarkable," Cybin's chief executive projected confidence in the asset on Monday, just days after launching a three-study Phase III programme. But whether the company can overcome the psychedelic pitfalls that have plagued other drug developers this year remains to be seen, especially as investors had a less than enthusiastic response to the data readout, sending Cybin's shares down 10% in Toronto and nearly 9% in New York on Monday.The company touted a 12-month 100% response rate for the seven patients who received two 16-mg doses of CYB003 three weeks apart. Of those patients, five (71%) achieved MDD remission at the one-year mark, as defined by a Montgomery-Asberg Depression Rating Scale (MADRS) total score ≤10.The average baseline MADRS score, including both the 16-mg and 12-mg dosing groups, was 32. Those who received the high-dose regimen saw a mean MADRS reduction of 23 points at 12 months. "Up to two thirds of MDD patients do not achieve remission with first-line antidepressants, which have defined the current treatment standard. With CYB003, we have the opportunity to pivot away from the chronic, daily treatments that often only offer symptomatic relief, and move towards more patient-friendly infrequent, long-lasting therapeutics for MDD patients who do not achieve remission with existing treatments," said CEO Doug Drysdale. "CYB003’s two doses per treatment cycle have the potential to free up capacity for new patients and improve accessibility to treatment." The candidate received breakthrough therapy designation from the FDA in March.Psychedelic setbacksWith the FDA rejection of Lykos Therapeutics' MDMA-based therapeutic in August, mood disorder experts are now looking ahead to late-stage psilocybin treatments as the most likely candidates to crack the psychedelic glass ceiling (see – KOL Views Q&A: Psychedelic developers need to learn from Lykos but all eyes now on make-or-break psilocybin efforts, says leading psychiatrist).FirstWord recently spoke with Collin Reiff, an assistant professor of psychiatry at New York University Grossman School of Medicine, who noted that Compass Pathways' clinical strategy for its synthetic psilocybin therapy COMP360 in treatment-resistant depression "is very smart. They are going about this in a very methodical way that should give them a good chance at success." However, Compass had its own setback last month when it announced that the pivotal readout for COMP360 — originally expected by year-end — has been pushed back to the second quarter of 2025. The data delay was also accompanied by a workforce reduction affecting 30% of Compass' employees (see – Spotlight On: Another confidence-shaker in psychedelic space arrives via Compass).The decision looks to have been an attempt by Compass to avoid one of the biggest issues that the FDA had with Lykos' data package for MDMA-assisted therapy — that its clinical trials were "functionally unblinded" since most patients guessed they had received the experimental treatment.Concerns over unblinding may have also spilled over into Cybin's stock move on Monday. While the firm was upbeat about the results of its Phase II trial and its newly launched Phase III PARADIGM programme, the available details on the three planned pivotal studies' design don't address how Cybin plans to ensure the integrity of its data.

TORONTO--( BUSINESS WIRE )--Cybin Inc. (NYSE American: CYBN) (Cboe CA:CYBN) (“ Cybin ” or the “ Company ”), a clinical-stage breakthrough neuropsychiatry company committed to revolutionizing mental healthcare by developing new and innovative next-generation treatment options, is pleased to announce that it has filed articles of amendment to consolidate the Company’s issued and outstanding common shares (the “ Common Shares ”) on the basis of one new Common Share for every 38 existing Common Shares (the “ Consolidation ”). The Consolidation is effective immediately and trading of the Common Shares reflecting the Consolidation will commence at the opening of trading today. As a result of the Consolidation, the 759,692,495 Common Shares issued and outstanding prior to the Consolidation have been reduced to approximately 19,991,907 Common Shares, subject to adjustment for treatment of fractional Common Shares. Each shareholder’s percentage ownership in the Company and proportional voting power remains unchanged after the Consolidation, except for minor changes and adjustments resulting from the treatment of any fractional Common Shares. The exercise price and number of Common Shares issuable upon exercise of the Company’s outstanding Common Share purchase warrants and options have been adjusted in accordance with the Consolidation. About Cybin Cybin is a clinical-stage breakthrough neuropsychiatry company on a mission to create safe and effective next-generation therapeutics to address the large unmet need for new and innovative treatment options for people who suffer from mental health conditions. Cybin’s goal of revolutionizing mental healthcare is supported by a network of world-class partners and internationally recognized scientists aimed at progressing proprietary drug discovery platforms, innovative drug delivery systems, novel formulation approaches and treatment regimens. Cybin is currently developing CYB003, a proprietary deuterated psilocin program for the treatment of major depressive disorder and CYB004, a proprietary deuterated dimethyltryptamine program for generalized anxiety disorder and has a research pipeline of investigational psychedelic-based compounds . Headquartered in Canada and founded in 2019, Cybin is operational in Canada, the United States, the United Kingdom, the Netherlands and Ireland. For Company updates and to learn more about Cybin, visit www.cybin.com or follow the Company on X, LinkedIn, YouTube and Instagram. Cautionary Notes and Forward-Looking Statements Certain statements in this news release relating to the Company are forward-looking statements and are prospective in nature. Forward-looking statements are not based on historical facts, but rather on current expectations and projections about future events and are therefore subject to risks and uncertainties which could cause actual results to differ materially from the future results expressed or implied by the forward-looking statements. These statements generally can be identified by the use of forward-looking words such as “may”, “should”, “could”, “intend”, “estimate”, “plan”, “anticipate”, “expect”, “believe” or “continue”, or the negative thereof or similar variations. Forward-looking statements in this news release include statements regarding the Company’s plans to engineer proprietary drug discovery platforms, innovative drug delivery systems, novel formulation approaches and treatment regimens for mental health conditions. 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: 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; implications of disease outbreaks on the Company's operations; and the risk factors set out in each of the Company's management's discussion and analysis for the three months ended June 30, 2024 and the Company’s annual information form for the year ended March 31, 2024, which are available under the Company's profile on www.sedarplus.ca and with the U.S. Securities and Exchange Commission on EDGAR at www.sec.gov . 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 psilocin, psilocybin, psychedelic tryptamine, tryptamine derivatives or other psychedelic compounds. The efficacy of such products has not been confirmed by approved research. There is no assurance that the use of psilocin, psilocybin, psychedelic tryptamine, tryptamine derivatives or other psychedelic compounds can diagnose, treat, cure or prevent any disease or condition. Rigorous scientific research and clinical trials are needed. 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 Cboe Canada, nor the NYSE American LLC stock exchange have approved or disapproved the contents of this news release and are not responsible for the adequacy and accuracy of the contents herein.