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TORONTO - Cybin Inc. (NYSE American:CYBN), a clinical-stage neuropsychiatry company with a market capitalization of $134.21 million, has announced a collaboration with Thermo Fisher Scientific to support the Phase 3 clinical supply and potential future commercial manufacturing of CYB003, a drug candidate for treating Major Depressive Disorder (MDD). According to InvestingPro data, the company maintains a strong liquidity position with a current ratio of 12.6, though it’s currently experiencing rapid cash burn. This partnership will involve the production of both drug substance and drug product at Thermo Fisher’s U.S. manufacturing sites.
The engagement with Thermo Fisher, a leader in serving science and offering Contract Development and Manufacturing Organization (CDMO) services, is aimed at accelerating the development of CYB003. According to Cybin’s CEO, Doug Drysdale, this collaboration will leverage Thermo Fisher’s manufacturing expertise and track record to advance the drug’s trajectory.
CYB003 has been granted Breakthrough Therapy Designation by the U.S. Food and Drug Administration (FDA) in March 2024, which could expedite its review and development process. The designation is in recognition of the potential to address the significant unmet medical need for more effective MDD treatments. InvestingPro analysis shows the company’s overall financial health score is FAIR, with particularly strong metrics in cash flow management despite the development-stage nature of its operations.
Cybin’s Phase 2 study of CYB003 in MDD reported a 100% response rate and a 71% remission rate among participants given two 16 mg doses. These results have led to the initiation of the multinational Phase 3 PARADIGM program in November 2024, aiming to evaluate CYB003 in a broader MDD patient population.
The company’s manufacturing operations for CYB003 are established in the United States, partnering with Thermo Fisher’s pharma services sites in Florence, South Carolina, for clinical supply and potential future commercialization, and in Cincinnati, Ohio, for capsule production.
Thermo Fisher’s President of Drug Substance, Pharma Services, Vincent Hingot, expressed pride in partnering with Cybin on the CYB003 program, highlighting the commitment to support innovative treatments for mental health.
Cybin, founded in 2019, is also developing CYB004, a proprietary molecule for anxiety disorder, and has a pipeline of investigational compounds focused on 5-HT receptors. The company operates in multiple countries, including Canada, the U.S., the U.K., the Netherlands, and Ireland. Trading at $6.38, the stock has seen a -27.66% return year-to-date, though InvestingPro analysis suggests the company is currently undervalued based on its Fair Value model. Subscribers can access 6 additional ProTips and comprehensive financial metrics to better understand the company’s potential.
The information in this article is based on a press release statement from Cybin Inc. and does not include any speculative content regarding the broader industry impacts or future trends.
In other recent news, Cybin Inc. has secured a U.S. patent for its CYB003 program, a deuterated psilocin analog designed to treat Major Depressive Disorder (MDD). This patent is anticipated to offer market exclusivity until 2041, enhancing the company’s intellectual property portfolio, which now includes over 80 granted patents. Cybin is actively advancing its Phase 3 clinical trials for the CYB003 program, with the APPROACH study currently underway and the EMBRACE study scheduled to commence in mid-2025. The company has expanded its strategic partnerships to 18 clinical sites in the United States as part of its multinational Phase 3 program, with plans to increase to approximately 45 sites. During Phase 2 trials, CYB003 demonstrated a 71% remission rate from depression symptoms over 12 months in patients with MDD. Additionally, Cybin is progressing with its CYB004 program for generalized anxiety disorder, which is currently in a Phase 2 study. The company emphasizes the importance of rigorous scientific research and clinical trials, acknowledging that regulatory approval is necessary for the commercialization of its products. Cybin’s management has highlighted the collaborative approach in its trials, aiming to streamline operations and potentially reduce completion time.
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