Psychedelic: atai Life Sciences reports BPL-003 study results

In this week’s “Psychedelic,” The Fly’s recurring series focused on psychedelic stock news, The Fly looks back on study results, an analyst initiation and an investment agreement.

ATAI REPORTS BPL-003 STUDY RESULTS: atai Life Sciences (ATAI) announced Tuesday topline results from Beckley Psytech’s Phase 2a open-label study of BPL-003 in 12 patients with moderate to severe alcohol use disorder. BPL-003 is a patent-protected synthetic intranasal formulation of 5-MeO-DMT benzoate designed to deliver rapid and durable treatment effects from a single dose with a short in-clinic treatment time. The results showed that a single dose of BPL-003, in combination with relapse prevention cognitive behavioral therapy, induced meaningful and sustained reduction in alcohol use and heavy drinking days in patients with moderate to severe AUD out to 12 weeks.

“We are encouraged by these exploratory results from Beckley Psytech, our strategic investment, which demonstrate the potential of short in-clinic psychedelic therapies to transform the treatment of substance use disorders,” stated Dr. Srinivas Rao, atai CEO. “The high rates of sustained abstinence in this study are particularly promising given the significant challenges patients with alcohol use disorder face in achieving and maintaining abstinence. These findings add to the growing body of evidence supporting the potential of BPL-003 in treating serious mental health disorders. We look forward to the Phase 2b data readout of BPL-003 in treatment-resistant depression expected mid-year.”

The 12-week Phase 2a open-label study enrolled 12 patients with moderate to severe AUD and evaluated the safety, tolerability, pharmacodynamic effects and impact on alcohol use of a single dose of BPL-003, in combination with relapse prevention cognitive behavioral therapy. Beckley Psytech plans to evaluate future development options for BPL-003 in substance use disorders and anticipates reporting additional clinical data from this study in 2025.

MIND MEDICINE INITIATED WITH OUTPERFORM: Evercore ISI initiated coverage of Mind Medicine (MNMD) with an Outperform rating and $23 price target on Tuesday, Mind Medicine, which is developing a novel oral formulation of LSD, has two lead indications, generalized anxiety disorder and major depressive disorder. Additionally, there are multiple large expansion opportunities, noted the analyst, who increasingly believes that psychedelics will play a role in future treatment paradigms.

Mind Medicine also announced Thursday that the first patient has been dosed in Panorama, its second Phase 3 study evaluating MM120 ODT, a proprietary, pharmaceutically optimized form of LSD for the treatment generalized anxiety disorder. The Panorama study will evaluate the efficacy and safety of MM120 ODT versus placebo, will be conducted in the United States and Europe, and is expected to enroll approximately 250 participants.

“This is an incredible time for MindMed, and we are optimistic about what lies ahead as we embark on our second Phase 3 study for MM120 ODT in GAD only weeks after the successful launch of our first Phase 3 study, Voyage,” said Dan Karlin, CMO. “MM120 ODT represents a potentially life-changing treatment for people living with GAD, and if our Phase 3 development program is successful, it could offer a differentiated and compelling option for one of the most significant unmet needs in psychiatry. We aspire to deliver a truly transformational treatment that we believe has the potential to change the trajectory of the ongoing brain health epidemic.”

HOPE THERAPEUTICS EXECUTES FUNDING AGREEMENT: HOPE Therapeutics, a wholly-owned subsidiary of NRx Pharmaceuticals (NRXP), announced Tuesday the signing and of a stock purchase agreement with Smith & Sauer as the first step in a $27M financing to fund the planned acquisition of HOPE clinics. The agreement provides for the immediate funding of $2M in NRx common stock and commits Smith and Sauer to purchase an additional $25M in newly issued Series A Preferred Stock of HOPE, the proceeds of which are intended to be used to initiate a nationwide rollup of Interventional Psychiatry Clinics to treat patients with severe, suicidal depression and PTSD. The first $6.75M tranche is committed by February 7 with the full $25M committed on or before April 1.

“Today’s transaction caps several months of intensive work as we have identified best-in-class interventional psychiatry clinics and assembled the capital from both Anson Funds and Smith and Sauer to consummate the initial acquisitions. The resources committed today are anticipated to bring the company to the $100M revenue threshold. We have initiated a financial advisory relationship with a leading investment bank to assemble the next $400M of capital required to build a national and international presence,” said Jonathan Javitt, NRx Chairman. “Psychedelic Medications such as ketamine, neuromodulation technologies such as TMS, and digital therapeutics have sparked a revolution in psychiatry where for the first time patients with life threatening conditions such as depression and PTSD hope for a brighter future.”

PHARMALA ISSUES FINANCIAL STATEMENTS: PharmAla Biotech (MDXXF) announced Wednesday that it had publicly filed its financial and operational results for the year ended November 30, 2024.

“In Q1, PharmAla saw a significant slowdown in our SAP revenue as we transitioned to our new distribution partner, Rane Pharma. However, this was counterbalanced by very strong growth in our Clinical Trial sales pathway, which is reflected in our growth in ‘Customer Deposits’ in our unaudited condensed consolidated interim financial statements and has largely been previously announced in individual press releases.” said Nick Kadysh, CEO. “With the re-establishment of our distribution operations for SAP, and shipments to US clinical trials, we look forward to increased movement of inventory in future quarters.”

During FY24, the company realized revenue of over C$1M, representing growth of C$503,000 or 95% year over year, lead by growth in MDMA product sales of C$723,000, a C$305,000 or 73% increase year over year. In FY24, the ompany also increased customer deposits by approximately C$19,000, which has continued to grow by C$74,000 in Q1.

CYBIN ADVANCES DEPRESSION PROGRAM: H.C. Wainwright reiterated a Buy rating and $190 price target on Cybin (CYBN) shares on Monday, telling investors in a research note that top-line data from the company’s anxiety program is on track for the first quarter of 2025 and from its pivotal depression program in 2026. Cybin’s programs are overall advancing in-line with the firm’s expectations, and H.C. Wainwright said it is looking forward to the next updates to drive potential upside.

OTHER PSYCHEDELIC STOCKS: Publicly-traded companies in the space include Algernon Pharmaceuticals (AGNPF), Allied Corp. (ALID), BetterLife (BETRF), Bright Minds Biosciences (DRUG), Clearmind (CMND), Compass Pathways (CMPS), Entheon Biomedical (ENTBF), Enveric Biosciences (ENVB), Filament Health (FLHLF), GH Research (GHRS), Incannex Healthcare (IXHL), MIRA Pharmaceuticals (MIRA), Mydecine Innovations (MYCOF), Numinus Wellness (NUMIF), Optimi Health (OPTHF), Pasithea Therapeutics (KTTA), PharmaTher (PHRRF), Psyence Biomedical (PBM), Psyence Group (PSYGF), Quantum BioPharma (QNTM), Relmada (RLMD), Revive Therapeutics (RVVTF), SciSparc (SPRC), Seelos Therapeutics (SEEL), Silo Pharma (SILO) and Synaptogenix (SNPX).