Cybin misses the end of summer target for Phase 3 study starting | Where to buy Skittles Moonrock online
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The company did nothing more than describe the study as imminent.
After a reverse share splitting, Cybin Inc. (NYSE American: CYBN) Updated Investors On the company’s pipeline.
Share consolidation
On Thursday, Cybin Complete its Share consolidation Reduce the number of outstanding share and increase the value per share. Shareholders approved a ratio of up to one share per 50 shares. However, it ended up being a ratio of one share per 38 shares. The 759,692,495 issued and outstanding shares before the move were reduced to approximately 19,991,907.
Missed start date
Cybin teased investors by teasing that the CBY003 phase 3 study would start imminently. However, it did not provide a date. Cybin has said Originally, the goal was to start the study in late summer 2024. However, now that September is nearing, this goal has been missed. When was August? Green Market Report Cybin, which reported the company’s earnings for the second quarter, said that the clinical sites had been selected for the Phase 3 trial, and that the company was on track to start enrolling patients in the near future.
Cybin informed investors in August of its intention to spend $13 million on the Phase 3 study for CYB003 MDD in summer 2024. Of that amount, $2.3 million had been spent in that quarter. Approximately $2.9 million of the $13 million spent in the 12 months ending March 31 2024 was spent, leaving an estimated $7.9 million remaining.
The company reported that it held a productive Type-B Initial Breakthrough Therapy meeting with the U.S. Food and Drug Administration in August in preparation for the launch of its CYB003 pivotal MDD program. In a statement, the company said that “Cybin has selected 30 high quality clinical sites in the United States and Europe for the upcoming Phase 3 Study.” The Phase 3 pivotal design incorporates a number of elements to address important methodological issues, such as functional blinding that is considered important for drugs of this class.
However, no patients beyond the selection of the site have been enrolled.
Cybin noted that the results of a completed Phase II MDD study on CYB003 showed rapid improvements in depression symptoms with a single dosage, and durable effects after two doses four months later, with a 75% remission in the 16mg group. The statement read: “The Company anticipates reporting 12-month Phase 2 efficacy results in early Q4 of 2024, which will provide further insights into CYB003’s potential to offer long-lasting relief to MDD patients.”
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