Trump says envoy Witkoff had productive meeting with Putin
TORONTO - Cybin Inc. (NYSE American:CYBN) (Cboe CA:CYBN), a clinical-stage neuropsychiatry company, today announced results from its 12-month Phase 2 study of CYB003, a proprietary psilocin analog in development for major depressive disorder (MDD). The study showed all participants responded to treatment, with 71% achieving remission after two 16 mg doses.
The data indicated a mean reduction of approximately 23 points in the Montgomery-Asberg Depression Rating Scale (MADRS) score from baseline at 12 months post-treatment, confirming the long-term efficacy and durability of CYB003's effects. Cybin's Chief Medical (TASE:PMCN) Officer, Amir Inamdar, stated the results validate the dosing regimen and demonstrate sustained relief for MDD patients.
The safety profile of CYB003 remained excellent throughout the study, with no new adverse events reported, including suicidality. This supports the potential of CYB003 as a transformative treatment for MDD, offering an alternative to the chronic daily treatments currently standard.
Cybin has initiated its Phase 3 PARADIGM multinational pivotal program to further evaluate the efficacy and safety of CYB003 in a larger MDD population. Additionally, the company expects to report Phase 2 topline results for CYB004, aimed at treating generalized anxiety disorder, in the first quarter of 2025.
The company's approach contrasts with current intermittent treatments like esketamine, ECT, and TMS, which typically require numerous outpatient visits. CYB003's two-dose treatment cycle could improve patient accessibility and reduce the burden on treatment centers.
Cybin's CEO, Doug Drysdale, expressed optimism about the potential shift in mental health care paradigms, emphasizing the importance of moving beyond symptomatic relief towards more enduring therapeutic solutions.
This announcement is based on a press release statement and constitutes a forward-looking statement, with risks and uncertainties that could cause actual results to differ materially. Cybin continues to work towards potential regulatory approval and commercialization of CYB003. The information presented is not an endorsement of the company's claims and does not imply the efficacy of the product has been confirmed by authorized research.
In other recent news, Cybin Inc. has reported a series of significant developments. Canaccord Genuity revised its price target for Cybin's shares to $96, down from the previous $114, while maintaining a Buy rating. This adjustment followed Cybin's second-quarter fiscal year 2025 results, where operating expenses were higher than expected, mainly due to share-based compensation related to recent senior hires.
Cybin has also initiated the PARADIGM Phase 3 program for CYB003, an adjunct treatment for major depressive disorder, and is preparing for its second pivotal study, EMBRACE. The firm has expressed optimism regarding these developments. Additionally, Cybin is on track to report top-line Phase 2 data for CYB004, a treatment for generalized anxiety disorder, in early 2025.
Furthermore, the company has secured a U.S. patent for molecules designed to treat Central Nervous System disorders, part of its CYB005 phenethylamines program. Cybin has also consolidated its shares, reducing the number from 759,692,495 to approximately 19,991,907. These are recent developments in Cybin's ongoing efforts to develop next-generation treatments for mental health conditions.
InvestingPro Insights
Cybin Inc.'s promising clinical results for CYB003 in treating major depressive disorder are particularly noteworthy given the company's current financial position. According to InvestingPro data, Cybin has a market capitalization of $236.09 million, reflecting investor interest in its potential breakthrough treatments.
InvestingPro Tips highlight that Cybin holds more cash than debt on its balance sheet, which is crucial for a clinical-stage company continuing to fund its research and development efforts. This financial cushion is especially important as the company is quickly burning through cash, a common scenario for biotech firms in the development phase.
Despite the positive clinical outcomes, it's worth noting that Cybin is not profitable over the last twelve months, with an adjusted operating income of -$96.72 million. This aligns with another InvestingPro Tip indicating that analysts do not anticipate the company will be profitable this year. However, the strong return over the last three months, as mentioned in the InvestingPro Tips, suggests growing investor confidence in Cybin's pipeline and recent clinical success.
The company's focus on developing transformative treatments with potentially fewer doses required could address the issue of weak gross profit margins, another point highlighted by InvestingPro. If CYB003 achieves regulatory approval, it could significantly improve Cybin's financial outlook.
Investors seeking a more comprehensive analysis can find 8 additional InvestingPro Tips for Cybin, offering deeper insights into the company's financial health and market position.
This article was generated with the support of AI and reviewed by an editor. For more information see our T&C.