Welcome to the News You Might Have Missed, a weekly roundup of psychedelic medicine news to help you catch up and stay informed.
Cybin Doses Last Patient in Part B of Phase 1 DMT Trial
Cybin moves its DMT program forward as it completes dosing of part B of its Phase 1 trial. For a deeper dive into Cybin’s pipeline and trials, see our extended interview with Cybin CEO Doug Drysdale.
“We are pleased with the continued progress we are making with our CYB004 program and excited to reach our next key milestone of first-in-human dosing with our novel CYB004 molecule,” said Doug Drysdale, Cybin’s Chief Executive Officer. “Through Part C of the trial, we will have the ability to evaluate CYB004 in humans earlier than expected and potentially demonstrate the advantages of deuteration on pharmacokinetic/pharmacodynamic parameters, enabling a less invasive and more convenient dose form that may eliminate the need for specialized and costly clinical centers for dosing.”
atai Life Sciences Reports Q1 2023 Financial Results and Highlights
Highlight from Q1 report include:
- RL-007: First patient dosed in the Phase 2b study of RL-007 in Cognitive Impairment Associated with Schizophrenia.
- GRX-917: Presented PD data from the completed Phase 1 study, which suggest the potential for anxiolytic effects without the significant sedative effects seen with benzodiazepines.
- VLS-01: Well-tolerated in Parts 1 (IV) and 2 (OTF) of the on-going Phase 1 study. Amended protocol to expand study into Part 3, which is expected to further optimize the PK and PD of our proprietary OTF formulation.
- COMPASS Pathways announced an acceleration of the Pivotal Trial 1 (COMP 005) part of the Phase 3 program in TRD, with topline data from Pivotal Trial 1 now expected in the summer of 2024.
- The Company’s $250M cash position and committed term loan funding is expected to fund operations into 1H 2026.
GH Research Reports First Quarter 2023 Financial Results and Business Highlights
GH Research reported financial results for the first quarter ended March 31, 2023 and provided business highlights. Highlights included advancing Phase 2b trial and cash, cash equivalents, other financial assets and marketable securities were $246.1 million as of March 31, 2023, compared to cash, cash equivalents and marketable securities of $251.7 million as of December 31, 2022.
COMPASS Pathways Announces First Quarter 2023 Financial Results and Business Highlights
Q1 highlights include:
- COMP360 Phase 3 pivotal program underway, patients have been treated in both trials
- CPT® III code for in-person psychedelic therapy support accepted by the American Medical Association
- Cash position at 31 March 2023 of $117.1 million, additional $26.9 million net cash raised through ATM facility to date in the second quarter
For more on Compass Pathways, its pipeline, and price projections, see our conversation with EF Hutton analyst here