TORONTO, February 14, 2024–(BUSINESS WIRE)–Cybin Inc. (NYSE American:CYBN) (Cboe CA:CYBN) (“Cybin” or the “Company“), a clinical-stage biopharmaceutical company committed to revolutionizing mental healthcare by developing new and innovative next-generation psychedelic treatment options, today reported unaudited financial results for its third quarter ended December 31, 2023, and recent business highlights.
“During the past three months, we have continued to make exciting progress with positive topline data from our CYB003 and DMT programs. The data collected from our clinical trials forms the foundation of our next set of value-creating milestones, as we advance our key programs this year. For CYB003, the three-month Phase 2 efficacy data is expected in Q1 and will provide insights into the durability of treatment effect in MDD. Promising outcomes, such as a 79% remission from depression at 6 weeks in our Phase 2 CYB003 trial, and important safety and dosing findings in our Phase 1 dDMT studies, validate our path forward. Plans are underway to initiate a Phase 3 multisite trial of CYB003 for MDD, and with FDA clearance, we are progressing to a Phase 2a study of CYB004 for the treatment of GAD. We are proud of the rapid progress we have made and look forward to the important work ahead of us. We are encouraged by the positive findings across our clinical-stage programs to date and believe we are well on our way to providing more effective and patient-friendly treatment alternatives for a multitude of mental health disorders.”
– Doug Drysdale, Chief Executive Officer of Cybin
Recent Business and Pipeline Highlights:
Announced positive Phase 2 topline efficacy and safety data for CYB003, the Company’s proprietary deuterated psilocybin analog, in MDD. The study achieved its primary efficacy endpoint with an impressive mean 14-point difference in Montgomery-Asberg Depression Rating Scale (“MADRS“) score reduction from baseline between CYB003 (12mg) vs. placebo (p=0.0005)1 at three weeks. At six weeks, incremental MADRS score reductions were seen with 79% of patients in remission from depression after just two 12mg doses of CYB003 — an improvement that is far superior when compared against approved antidepressants and recently reported data with other psychedelics. Based on these encouraging results, and coupled with the fact that CYB003 is being developed as an adjunctive treatment that does not require candidates to discontinue the use of existing antidepressants, the Company intends to commence an international, multisite Phase 3 trial to further evaluate the safety and efficacy of CYB003 capsules in a larger MDD patient population2.
Completed Phase 1 studies of intravenous (“IV”) CYB004 and IM and IV SPL028 and reported positive topline safety, pharmacokinetic (“PK”) and pharmacodynamic (“PD”) data.
- CYB004 demonstrated robust and rapid onset of psychedelic effects at lower doses compared to native N,N-dimethyltryptamine (“DMT“), suggesting potential as a short-acting, scalable treatment.
- Well-tolerated with no serious adverse events, and the majority of adverse events were mild to moderate and self-limiting.
- The study identified an IM dose of SPL028 that resulted in a breakthrough psychedelic experience, with a duration range of 55-120 minutes. IV and IM SPL028 demonstrated a favorable safety and tolerability profile, with no serious adverse events observed. The majority of adverse events were mild to moderate and self-limiting.
- These results support the development of IM dosing, which provides a more convenient and patient-friendly administration route that avoids the need for an IV infusion pump, specialist equipment, staffing and training.
- Combined Phase 1 results from DMT program support progression to a Phase 2a study in GAD in the first quarter of 20242.
Key takeaways from dDMT studies:
- CYB004 and SPL028 demonstrated similar PK and PD profiles, which allow for synergistic insights that are relevant across molecules.
- PK profiles for both molecules demonstrated concentrations in the effective range.
- IM dosing of SPL028 produced robust psychedelic effects lasting a short duration in the majority of subjects.
Received FDA clearance to initiate Phase 2a study of CYB004 in GAD. The Company intends to initiate a Phase 2a study of CYB004 in the first quarter of 20242. The study will be a randomized, double-blind, active-controlled trial to assess the preliminary clinical efficacy, safety, tolerability, PK, and PD of CYB004 in participants with GAD. This trial will be conducted at study sites in the United States.
Strengthened patent portfolio with the addition of 6 new patents in key jurisdictions.
1. The United States Patent and Trademark Office (“USPTO“) granted U.S. patent 11,834,410 in support of the Company’s CYB003 program. The patent includes composition of matter claims to pharmaceutical compositions within Cybin’s CYB003 program, as well as claims directed toward the therapeutic treatment of MDD, treatment-resistant depression, and alcohol use disorder, and is expected to provide exclusivity until at least 2041.
2. The USPTO granted U.S. patent 11,771,681 in support of the Company’s dDMT program. The patent provides composition of matter protection for certain deuterated analogs of DMT.
3. The USPTO granted U.S. patent 11,773,062 in support of the Company’s dDMT program. The patent provides protection for the medical use and the novel, efficient and scalable synthesis of certain analogs of DMT.
4. The Canadian Intellectual Property Office granted CA patent 3,179,161 in support of the Company’s dDMT program. The patent provides protection for formulations of certain deuterated analogs of DMT.
5. The Japanese Patent Office granted JP patent 7422473 in support of the Company’s dDMT program. The patent provides protection for the novel, efficient and scalable synthesis of certain deuterated analogs of DMT.
6. The Japanese Patent Office granted JP patent 7422474 in support of the Company’s dDMT program. The patent provides protection for formulations of certain deuterated analogs of DMT.
Continued extensive engagement with the scientific community, showcasing advancements in clinical and preclinical programs. The Company shared four poster presentations at the 2023 American College of Neuropsychopharmacology Annual Meeting, highlighting data from across its CYB003 and dDMT clinical programs, as well as preclinical development programs.
Upcoming Clinical Milestones and Future Studies:2
CYB003 – Deuterated Psilocybin Analog Program
- Phase 2 three-month efficacy data for CYB003 in MDD expected in Q1 2024.
- CYB003 Phase 1/2a data was submitted to the FDA in Q4 2023 to support end of Phase 2 meeting in Q1 2024.
- Initiate a pivotal, international, multisite Phase 3 trial in Q2 2024 to further evaluate the safety and efficacy of CYB003 capsules in a larger MDD patient population.
- Initiate Phase 2a study in participants with generalized anxiety disorder in Q1 2024.
Third-Quarter Financial Information
- Cash totaled C$39.0 million as of December 31, 2023.
- With the previously announced public offerings of units of the Company (the “Units”) and a combination of the Company’s current cash position, current at-the-market equity program and assuming the exercise in full of the warrants issued as part of the Units, the Company has access to over C$121 million.
- Net loss was C$30.3 million for the quarter ended December 31, 2023, compared to a net loss of C$10.7 million in the same period last year.
- Cash-based operating expenses totaled C$17.1 million for the quarter ended December 31, 2023, compared to C$11.1 million, in the prior year quarter.
- Cash flows used in operating activities were C$19.0 million for the quarter ended December 31, 2023, compared to C$10.8 million in the same period last year.
- Cash flows received from financing activities were C$42.4 million for the quarter ended December 31, 2023, compared to C$3.5 million in the same period last year, related to the net proceeds on the issuance of Common Shares through the Company’s August 3, 2023 and November 14, 2023 financing and its at-the-market equity program.
Cybin is a clinical-stage biopharmaceutical company on a mission to create safe and effective psychedelic-based therapeutics to address the large unmet need for new and innovative treatment options for people who suffer from mental health conditions.
Cybin’s goal of revolutionizing mental healthcare is supported by a network of world-class partners and internationally recognized scientists aimed at progressing proprietary drug discovery platforms, innovative drug delivery systems, novel formulation approaches and treatment regimens. Cybin is currently developing CYB003, a proprietary deuterated psilocybin analog for the treatment of major depressive disorder and CYB004, a proprietary dDMT molecule for generalized anxiety disorder and has a research pipeline of investigational psychedelic-based compounds.
Headquartered in Canada and founded in 2019, Cybin is operational in Canada, the United States, the United Kingdom, the Netherlands and Ireland. For Company updates and to learn more about Cybin, visit www.cybin.com or follow the Company on X, LinkedIn, YouTube and Instagram.