Cybin has started the week off with several newsworthy stories. First, the company released its First Quarter Financial Results and Recent Business Highlights; and then late yesterday the firm announced an equity raising program for up to $35 million in capital.
Some highlights from Cybin’s Q1 results:
- Started enrollment for its Phase 1/2a trial of CYB003 in major depressive disorder (“MDD”). Received a “may proceed letter” and Investigational New Drug Application clearance from the U.S. Food and Drug Administration (the “FDA”) for its Phase 1/2a study in June 2022.
- Plans to report interim safety and PK data from the Phase 1/2a study at the end of calendar year 2022.(1)
- Completed the acquisition of a Phase 1 DMT study from Entheon. The CYB004-E study, which is ongoing at the Centre for Human Drug Research in the Netherlands, is the largest Phase 1 DMT study conducted to date.
- $42.5 million in cash as of June 30, 2022, enough runway from another full year of operation (approx).
As for the new capital, Cybin has established an at-the-market equity program that allows the issuing and selling of up to USD$35,000,000 of common shares. This is a preparatory move, allowing Cybin the flexibility to more quickly issue shares and raise capital, a wise step considering the market’s volatile conditions.
See the full press release below.
Cybin Inc. Reports First Quarter Financial Results and Recent Business Highlights
08/08/2022
TORONTO–(BUSINESS WIRE)– Cybin Inc. (NEO:CYBN) (NYSE American:CYBN) (“Cybin” or the “Company”), a biopharmaceutical company focused on progressing “Psychedelics to TherapeuticsTM”, today reported unaudited financial results for its first quarter ended June 30, 2022 and recent business highlights.
“Looking back at the last 12 months, we have made positive progress toward our goal of advancing psychedelics to therapeutics. In that time, we have moved from the lab to the clinic where we now have two major development programs underway,” said Doug Drysdale, Chief Executive Officer of Cybin.
“Our lead candidate CYB003 is the first novel psilocybin analog to be evaluated in a Phase 1/2a trial for the treatment of major depressive disorder. Enrollment has commenced and interim pharmacokinetic and safety data is expected at the end of the year.(1) Our Phase 1 CYB004-E study to evaluate the safety, pharmacokinetics and pharmacodynamics of a target-controlled intravenous infusion of DMT in healthy tobacco smokers is also underway. This is the largest Phase 1 DMT study to date and has the potential to yield important information as we look to potentially create improved treatment options for anxiety disorders,” continued Drysdale.
Recent Business and Pipeline Highlights:
- Initiated enrollment for its first-in-human Phase 1/2a trial of CYB003 in major depressive disorder (“MDD”). The Company announced that it received a “may proceed letter” and Investigational New Drug Application clearance from the U.S. Food and Drug Administration (the “FDA“) for its Phase 1/2a study in June 2022. The Phase 1/2a trial is a randomized, double-blind, placebo-controlled study evaluating up to two doses of CYB003 in approximately 32 patients with moderate to severe MDD. The Company has partnered with Clinilabs Drug Development Corporation, a full-service contract research organization with expertise in central nervous system drug development, to conduct this Phase 1/2a trial. CYB003 is designed to potentially address the challenges and limitations of oral psilocybin. Based on preclinical data, CYB003 achieved less variability in plasma levels, faster onset of action, and shorter duration of effect.
- Completed the acquisition of a Phase 1 DMT study from Entheon Biomedical Corp. The CYB004-E study, which is ongoing at the Centre for Human Drug Research in the Netherlands, is the largest Phase 1 DMT study conducted to date. The study is assessing the pharmacokinetics and pharmacodynamics of intravenous DMT in 50 healthy tobacco smokers, and is anticipated to provide safety and dosing data to inform the clinical development plan for CYB004. In preclinical studies, CYB004 demonstrated key advantages over intravenous and inhaled DMT, including longer duration and rapid onset of effect, improved bioavailability, and low variability.
- Continued to build the Company’s intellectual property portfolio, with 1 patent issued and 19 patents pending across six patent families. The Company’s IP portfolio includes a United States Patent and Trademark Office patent covering certain deuterated forms of DMT and 5-MeO-DMT. This patent protects CYB004 as a putative new chemical entity. In addition, an international patent application was published by the World Intellectual Property Organization covering inhalation delivery methods for multiple psychedelic molecules.
- Completed more than 200 preclinical studies to date, supporting the Company’s growing portfolio of proprietary psychedelic molecules. This highlights Cybin’s dedication to researching and developing potential psychedelic treatments for patients in need. To date, the Company has developed over 50 novel compounds, and continues to advance preclinical work on its proprietary molecules being developed for the potential treatment of various mental health conditions.
Upcoming Pipeline and Strategic Milestones:
CYB003: Deuterated psilocybin analog for the potential treatment of MDD and AUD
- The Company plans to report interim safety and PK data from the Phase 1/2a study at the end of calendar year 2022.(1)
CYB004: Deuterated DMT for the potential treatment of anxiety disorders
- The CYB004-E Phase 1 study is currently underway, and is evaluating DMT in 50 healthy volunteers who smoke tobacco. The Company expects the last subject visit by November, and to complete the Phase 1 study in the first quarter of calendar 2023.(1)
CYB005: Phenethylamine derivative for the potential treatment of neuroinflammation
- The Company expects to report preclinical data for CYB005 in the second half of calendar year 2022, at which time the Company expects to nominate a candidate and complete its assessment of the potential path forward for this candidate, including whether to develop internally or by way of a potential third party partnership.(2)
Kernel Flow®
- Cybin and its partner Kernel expect to report data from a Phase 1 feasibility study evaluating brain activity following ketamine administration and the participant’s experience wearing the Flow headset in the fourth quarter of calendar year 2022. Results from the study will determine the next steps forward for this important program.(3)
“Our commitment to finding safe and more effective treatments across the spectrum of mental health conditions has never been greater. Looking ahead, we are especially encouraged by the support that the healing potential of psychedelics continues to receive by many governmental and mainstream organizations. This is an exciting time for Cybin and for the industry as a whole as we move even closer to bringing potential psychedelic therapies to people in need,” concluded Drysdale.
First Quarter Financial Highlights:
- Cash and cash equivalents totaled to C$42.5 million as of June 30, 2022.
- Cash-based operating expenses totaled C$11.2 million for the quarter ended June 30, 2022, of which C$1.1 million were one-time, non-recurring costs. Non-cash expenses totaled C$1.9 million for a net loss of C$13.1 million.
- Cash flows used in operating activities were C$11.1 million for the quarter ended June 30, 2022 of which C$1.1 million were one-time, non-recurring costs.
About Cybin
Cybin is a leading ethical biopharmaceutical company, working with a network of world-class partners and internationally recognized scientists, on a mission to create safe and effective therapeutics for patients to address a multitude of mental health issues. Headquartered in Canada and founded in 2019, Cybin is operational in Canada, the United States, the United Kingdom, the Netherlands and Ireland. The Company is focused on progressing Psychedelics to Therapeutics by engineering proprietary drug discovery platforms, innovative drug delivery systems, novel formulation approaches and treatment regimens for mental health disorders.
Investor & Media Contact:
Leah Gibson
Vice President, Investor Relations & Strategic Communications
Cybin Inc.
irteam@cybin.com – or – media@cybin.com
Gabriel Fahel
Chief Legal Officer
Cybin Inc.
1-866-292-460
Source: Cybin Inc.
