Psychedelic: atai, Beckly Psytech to combine in all-share transaction

In this week’s “Psychedelic,” The Fly’s recurring series focused on psychedelic stock news, The Fly looks back on a business combination agreement, patient enrollment and patent issuances.

ATAI, BECKLEY PSYTECH TO COMBINE IN ALL-SHARE TRANSACTION: On Monday, atai Life Sciences (ATAI) and Beckley Psytech announced a definitive agreement under which atai and Beckley plan to combine in an all-share transaction subject to pre-agreed BPL-003 Phase 2b success criteria. atai made a strategic investment in Beckley in January 2024. Under the terms of the deal, Beckley’s shareholders will be issued approximately 105M new shares as consideration for the remaining shares of Beckley not presently held by atai. These newly issued shares equate to approximately 31% of the combined company on a fully diluted basis, based on the treasury stock method, upon closing of the transaction and the concurrent private placement, and value Beckley at approximately $390M. These newly issued atai shares are subject to a lock-up wherein, following the completion of the lock-up period, 1/12 of the shares are released every month. Additionally, Apeiron Investment Group voluntarily entered into a similar lock-up agreement covering all of its shares in atai. Beckley also intends to distribute Eleusis Holdings and its subsidiaries, which hold assets and funding related to its second clinical-stage asset, ELE-101, out of Beckley prior to closing of the transaction. atai’s Supervisory Board and Management Board and Beckley’s Board of Directors have approved the transaction. The transaction is expected to close in the second half of 2025.

“The strategic combination marks a transformational moment, solidifying us as a leader in rapid-acting and accessible psychedelic treatments for mental health conditions with a pipeline of potential first-in-class and best-in-class assets,” stated Srinivas Rao, CEO of atai. “With a unified vision and a synergistic pipeline, we believe we are well-positioned to unlock the strategic value of our clinical development programs for both patients and shareholders. Together, we plan to move confidently towards our goal of bringing innovative interventional psychiatry therapies to patients in need of new treatments.”

CLEARMIND ANNOUNCES ENROLLMENT IN CMND-100 TRIAL: Clearmind Medicine (CMND) announced Thursday the enrollment of the first patient in its Phase I/IIa clinical trial for CMND-100, a proprietary MEAI-based oral drug candidate aimed at treating Alcohol Use Disorder. The first patient was enrolled at Yale School of Medicine’s Department of Psychiatry. The trial is evaluating the safety, tolerability, and pharmacokinetic profile of CMND-100, with preliminary efficacy assessments to explore its potential in reducing alcohol cravings and consumption.

“The enrollment of our first patient at Yale School of Medicine marks a pivotal milestone in the development of CMND-100,” said Dr. Adi Zuloff-Shani, CEO. “This advancement brings us one step closer to offering an innovative solution for those affected by AUD, a condition with significant unmet medical needs. The substance use disorder treatment market in the U.S. alone was valued at $35.1B in 2021 and is projected to grow to $60.2B by 2029. Moreover, there are hundreds of millions of individuals around the globe afflicted by AUD. However, the market has been constrained due to the limited effectiveness and adverse side effects of current treatment options. We are executing on our development strategy and are optimistic about the potential of our MEAI-based therapy to offer a safe, effective solution that can transform lives.”

ENVERIC ISSUED U.S. PATENT: Enveric Biosciences (ENVB) announced Tuesday the issuance of a new U.S. patent. The patent strengthens Enveric’s intellectual property portfolio and covers a structurally diverse class of novel molecules with potential therapeutic applications in the treatment of sleep and central nervous system disorders. The newly granted patent, titled, “Hydroxylated Psilocybin Derivatives and Methods of Using,” expands Enveric’s proprietary drug discovery platform and includes a unique subset of compounds that demonstrate selective binding to the melatonin MT1 receptor, an established, therapeutic target known to regulate circadian rhythm and sleep-wake cycles. These molecules were identified through Enveric’s structure-activity screening efforts.

Joseph Tucker, CEO of Enveric, commented “This newly issued patent adds to the growing body of intellectual property that underpins our pipeline of next-generation neuroplastogenic therapeutics. The inclusion of selective melatonin receptor-binding compounds broadens our ability to target sleep disorders, a prevalent category representing a multi-billion-dollar annual market. This intellectual property milestone strengthens our strategic position to advance differentiated candidates in areas where current treatment options remain limited or suboptimal.”

CYBIN ISSUED U.S. PATENT FOR CYB004: Cybin (CYBN) announced Tuesday that the United States Patent and Trademark Office has granted U.S. patent 12,318,477 in support of its CYB004 deuterated DMT program in development for the treatment of generalized anxiety disorder. The patent, which is expected to provide exclusivity until 2040, includes claims to novel formulations of DMT and deuterated isotopologues for intramuscular injection, including CYB004.

“Patents are extremely valuable assets, and protection for our lead product candidates is a top priority for us,” said Doug Drysdale, CEO. “We believe that our CYB004 program has the potential to deliver short-duration, rapid-acting treatment for anxiety disorders and offer more patient-friendly dosing methods such as IM administration. The issuance of this additional patent in support of CYB004 adds further validation of this important program. Dosing is currently underway in our Phase 2 study evaluating CYB004 in generalized anxiety disorder, and we expect the study to complete around mid-year. I’m proud that Cybin has amassed one of the strongest IP portfolios in the sector with more than 90 granted patents and over 230 pending applications.”

GH RESEARCH ASSUMED WITH OVERWEIGHT: On Wednesday, Cantor Fitzgerald assumed coverage of GH Research (GHRS) with an Overweight rating and $25 price target. Data generated for psychedelics across a number of mental health disorders have been “transformational,” and the unmet need is “enormous” and growing, the analyst said. The firm sees the psychedelic total addressable market ultimately reaching $50B per year, which would be roughly 1M-1.5M patients treated per year, still only modest penetration, and believes there is room for plenty of successful options and companies offering psilocybin and novel synthetic products.

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