Welcome to the News You Might Have Missed, a weekly roundup of psychedelic medicine headlines to help you catch up and stay informed. It was a busy week with lots of news, have a look and see you next week for another update.
MAPS Completes Second Phase 3 MDMA Trial
MAPS Public Benefit Corporation has announced the final participant visit has been completed in MAPP2, a multi-site Phase 3 study of MDMA-assisted therapy for post-traumatic stress disorder (“PTSD”).
The top-line results are expected in the first quarter of 2023. This is the second of two Phase 3 pivotal trials and will be the basis for the New Drug Application expected to be submitted to the U.S. Food and Drug Administration in the third quarter of 2023.
Psychedelics Making Progress in U.S. Congress
Following up on last week’s legalization of psychedelic therapy in Colorado, this week saw a string of progressive psychedelic medicine news from an unlikely source — the U.S. Congress. First we had the announcement that a new, first-of-its-kind congressional caucus has been formed to advance psychedelic therapy. While in the Senate, senior senators Cory Booker (D-NJ) and Rand Paul (R-KY) filed a bill that would require the Drug Enforcement Administration (DEA) to reschedule breakthrough therapies like psilocybin and MDMA from Schedule I to II.
Clearmind Medicine Uplists to the NASDAQ
In surprising news, lesser-known psychedelic upstart Clearmind Medicine has uplisted to the NASDAQ. Running under the radar for now, the firm has announced a $7.5 million public offering and will start trading on the NASDAQ on Nov 15th, under the symbol CMND.
Awakn Life Sciences Announces Closing of Private Placement
Awakn has announced the closing of a second and final tranche of its previously announced non-brokered private placement through the issuance of an additional 3,395,812 units at a price of $0.55 per Unit for additional gross proceeds of $1,867,697. In total, including the first tranche, the company has issued 5,557,630 Units at $0.55 for a total value at $3,056,697.
MindMed Reports Third Quarter 2022 Financial Results and Business Highlights
Robert Barrow, Chief Executive Officer and Director of MindMed. “Throughout the third quarter, we have taken meaningful steps to reduce our cash expenditures and we further bolstered our balance sheet by raising approximately $60 million. We believe our strong financial position provides the Company with necessary funding to prepare for later stage clinical development of MM-120 while continuing our pursuit to retain, protect, and build the Company’s intellectual property portfolio.”
- Initiated Phase 2b dose-optimization trial in patients with Generalized Anxiety Disorder, with first patients dosed in Q3 2022 and key clinical readout expected in late 2023
- Advanced IND-enabling studies for MM-402 and initiated Phase 1 investigator-initiated trial in Q3 2022
- Cash and cash equivalents of $154.5 million expected to fund current operating plan into first half of 2025
Want to catch up on more industry news? Check out a previous edition of the News You Might Have Missed