Cybin Inc. (NEO:CYBN) (NYSE: CYBN) provided a corporate update outlining access to capital and upcoming clinical milestones. Cybin stated that it had a potential funding of C$70 million funding through a combination of the previously announced common share purchase agreement and current “at-the-market” equity program. Cybin announced at the end of May that it had signed a purchase agreement with Lincoln Park Capital Fund to purchase up to $30 million of the company’s shares over a 36 month period. Cybin is currently a going concern according to the auditors.
“The second half of 2023 will be pivotal for Cybin as we expect topline clinical data readouts from both our Phase 1/2a trial of CYB003, our deuterated psilocybin analog, and from our Phase 1 trial of CYB004, our deuterated DMT molecule. Through a combination of the company’s recently announced common share purchase agreement from Lincoln Park Capital Fund and the ongoing at-the-market offering, the company has done an admirable job of securing access to capital in light of current market conditions. The potential access to capital should provide Cybin with the cash runway needed to complete these value-driving clinical milestones and enable us to continue focusing on clinical execution with the ultimate goal of bringing improved therapeutic options to patients in need,” said Doug Drysdale, Chief Executive Officer of Cybin.
In February, Cybin reported its third quarter earnings for the period that ended in December 2022. At that time, the company had burned through quite a bit of cash as it reported C$22 million in cash at the of the year versus C$53 million at the end of March 2022. The company has not announced when it will release its fourth quarter earnings.
Cybin outlined its upcoming milestones as follows:
- Completion of CYB003 dosing in MDD cohorts expected in Q3 2023
- Topline efficacy data readout from CYB003 Phase 1/2a clinical trial expected in late Q3 2023
- U.S. Food and Drug Administration (“FDA”) submission of CYB003 Phase 1/2a data for pivotal studies expected in Q4 2023
Cybin noted that its interim findings from the ongoing Phase 1/2a clinical trial evaluating CYB003 demonstrated positive observations, including a rapid and short-acting psychedelic response in participants. The company’s statement read, “Participants received single oral doses of CYB003 at 1 milligram (“mg”), 3mg, 8mg, and 10mg, respectively, and all doses were well-tolerated with no serious adverse events reported. Most notably, participants reported meaningful and robust psychedelic effects at the 8mg and 10mg doses, confirming a complete mystical experience was achieved. These interim findings demonstrate that CYB003 was rapid and short acting, and reached a psychedelic effect at low doses, while maintaining a safe and well-tolerated therapeutic profile.”
CYB003 was created to address the challenges and limitations of oral psilocybin. CYB003’s therapeutic profile as a potentially differentiated treatment for MDD is expected to provide consistent and predictable dosing.
CYB004 is the company’s DMT compound that is being evaluated as a potential treatment for Generalized Anxiety Disorder. CYB004 is secured by a U.S. composition of matter patent with protection through 2041. The company said it expects announcing topline data from the Phase 1 study of CYB004 in late Q3 2023.