11:14:28 EDT Sun 23 Jun 2024
Enter Symbol
or Name
USA
CA



Cybin Inc
Symbol CYBN
Shares Issued 410,855,285
Close 2024-02-13 C$ 0.475
Market Cap C$ 195,156,260
Recent Sedar Documents

Cybin has cash of $39-million at Dec. 31

2024-02-14 12:40 ET - News Release

Mr. Doug Drysdale reports

CYBIN REPORTS THIRD QUARTER FINANCIAL RESULTS AND RECENT BUSINESS HIGHLIGHTS

Cybin Inc. has released unaudited financial results for its third quarter ended Dec. 31, 2023, and recent business highlights.

"During the past three months, we have continued to make exciting progress with positive top-line data from our CYB003 and DMT programs," said Doug Drysdale, chief executive officer of Cybin. "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-per-cent remission from depression at six 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 under way 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," concluded Mr. Drysdale.

Recent business and pipeline highlights

Announced positive phase 2 top-line efficacy and safety data for CYB003, the company's proprietary deuterated psilocybin analogue, in major depressive disorder (MDD). The study achieved its primary efficacy end point with an impressive mean 14-point difference in Montgomery-Asberg depression rating scale (MADRS) score reduction from baseline between CYB003 (12 milligrams) versus placebo at three weeks. At six weeks, incremental MADRS score reductions were seen with 79 per cent of patients in remission from depression after just two 12 mg 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 population.

Completed phase 1 studies of intravenous (IV) CYB004 and IM and IV SPL028 and reported positive top-line safety, pharmacokinetic (PK) and pharmacodynamic (PD) data:

  • CYB004 demonstrated robust and rapid onset of psychedelic effects at lower doses compared with 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 to 120 minutes. IV and IM SPL028 demonstrated a favourable 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 generalized anxiety disorder (GAD) in the first quarter of 20242.

Key takeaways from deuterated DMT 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 Food and Drug Administration 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 2024. 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 six 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 analogues 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 analogues 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 analogues 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 analogues 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 analogues 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.

Coming clinical milestones and future studies

CYB003 -- deuterated psilocybin analogue program:

  • Phase 2 three-month efficacy data for CYB003 in MDD are expected in Q1 2024.
  • CYB003 phase 1/2a data were 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.

dDMT program:

  • Initiate phase 2a study in participants with generalized anxiety disorder in Q1 2024.

Third quarter financial information:

  • Cash totalled $39-million as of Dec, 31, 2023.
  • With the previously announced public offerings of units of the company 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 $121-million.
  • Net loss was $30.3-million for the quarter ended Dec. 31, 2023, compared with a net loss of $10.7-million in the same period last year.
  • Cash-based operating expenses totalled $17.1-million for the quarter ended Dec. 31, 2023, compared with $11.1-million in the prior-year quarter.
  • Cash flows used in operating activities were $19-million for the quarter ended Dec. 31, 2023, compared with $10.8-million in the same period last year.
  • Cash flows received from financing activities were $42.4-million for the quarter ended Dec. 31, 2023, compared with $3.5-million in the same period last year, related to the net proceeds on the issuance of common shares through the company's Aug. 3, 2023, and Nov. 14, 2023, financing and its at-the-market equity program.

About Cybin Inc.

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 health care 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 analogue 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.

We seek Safe Harbor.

© 2024 Canjex Publishing Ltd. All rights reserved.