Psychedelic: atai Life Sciences, NRx report quarterly results

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Fri, Mar 21, 2025, 9:50 AM 8 min read

EARNINGS: On Monday, atai Life Sciences (ATAI) reported a fourth quarter loss per share of (24c) on revenue loss of ($5,000), which compared to analyst estimates of a loss per share of (15c) and revenue of $18,000 for the same period last year. As of December 31, the company had cash, cash equivalents, restricted cash and short-term securities of $72.3M compared to $154.2M as of December 31, 2023. In February, the company completed an equity offering with net proceeds of $59.2M and now expects its cash, short-term securities, and public equity holdings to be sufficient to fund operations into 2027.

“We are beginning the year in a strong financial position, thanks to the recent capital raise, which extends our runway into 2027, beyond when we expect the topline data readouts from the Phase 2 clinical trials of our two core programs, VLS-01 and EMP-01, in 1Q26” stated Srinivas Rao, CEO. “Our team is focused on executing these trials rigorously and efficiently to drive forward our mission to transform patient outcomes in mental health. We also look forward to several key milestones this year, notably Beckley Psytech’s BPL-003 Phase 2b topline results in patients with treatment-resistant depression as well as RL-007 in patients with cognitive impairment associated with schizophrenia, both expected mid-2025.”

Additionally on Monday, NRx Pharmaceuticals (NRXP) reported a FY24 loss per share of ($2.36), which compared to a loss per share of ($3.98) for the same period last year. As of December 31, the company had approximately $1.4M in cash and cash equivalents. In January, the company completed two financings with aggregate gross proceeds of approximately $8.5M. Management believes that current available cash resources will be sufficient to support ongoing operations through at least the end of 2025.

“Our work in the fourth quarter of 2024 and into 2025 has driven significant advances for our company and investors. We have retired debt that was impeding the launch of HOPE Therapeutics and brought new investors into the Company who are aligned with our objectives. We launched the filing of a New Drug Application for NRX-100 for the treatment of Suicidal Depression: a major milestone for NRx. We also moved NRX-101 toward it’s NDA for Accelerated Approval in bipolar depression in patients at risk of akathisia, and made meaningful progress building HOPE’s best-in-class network of Interventional Psychiatry Clinics. Additionally, two potential strategic transactions that are under negotiation could further accelerate our progress. These accomplishments advance our mission of preventing and treating suicide: work that is critical to our patients, their families and our country,” said Jonathan Javitt, CEO.

CLEARMIND SIGNS LOI WITH POLYRIZON: Clearmind Medicine (CMND) announced Wednesday that it has (PLRZ) to develop a novel intranasal formulation for its psychedelic-based treatment applications. The collaboration will explore the potential of Clearmind’s proprietary drug candidate, 5-Methoxy-2-aminoindane, alone or in combination with Palmitoylethanolamide, through intranasal administration. This initiative aims to enhance bioavailability and optimize the therapeutic effect of Clearmind’s psychedelic-based treatments. Under the terms of the LOI, Clearmind and Polyrizon will conduct research and development efforts to achieve a proof of concept for an intranasal formulation of MEAI and MEAI-PEA combinations. The companies will assess the feasibility of intranasal drug delivery, which offers several potential advantages over traditional administration methods, including faster absorption and onset of action, high bioavailability for increased therapeutic effects and enhanced patient compliance due to non-invasive administration.

“This collaboration represents an exciting step forward in our efforts to continue innovating psychedelic-based treatments,” said Adi Zuloff-Shani, CEO. “We believe intranasal administration has the potential to improve patient outcomes by providing a faster-acting, more efficient, and user-friendly treatment option. This agreement aligns with our commitment to developing innovative and accessible solutions for mental health and addiction treatment.”

Additionally on Tuesday, Clearmind Medicine announced that it initiated its Phase I/IIa clinical trial investigating the safety, tolerability and full pharmacokinetic profile of its treatment, CMND-100, in Alcohol Use Disorder patients. This study is the first clinical application of the company’s proprietary CMND-100 platform. The first site to be initiated is IMCA in Israel and will be led by Prof. Mark Weiser, head of the Psychiatric Division at the Sheba Medical Center.

“Transitioning to a clinical stage pharmaceutical company is a major milestone for our Company, enabling us to evaluate whether the promising results from our animal studies will translate to human clinical trial participants with AUD,” said Zuloff-Shani. “Previously announced preclinical data on alcohol curb supports the potential ofCMND-100 as a novel and effective treatment approach for alcoholism, addressing a significant unmet medical need.”

COMPASS REPORTS PUBLICATION OF COMP004 RESULTS: Compass Pathways (CMPS) announced Tuesday the publication of results from the COMP004 study, an observational 52-week follow-up from the Phase 2 COMP001 and COMP003 trials of COMP360 psilocybin treatment in patients with treatment-resistant depression. The COMP004 study’s findings suggest that over a 52-week period, a single administration of 25 mg COMP360 psilocybin demonstrated a longer maintenance of antidepressant effects compared to the 1 mg and 10 mg doses. The results of COMP004 build upon previous findings from the Phase 2b trial COMP001, which showed that a single 25mg dose of COMP360 psilocybin was associated with a rapid and highly statistically significant reduction in depressive symptoms compared to COMP360 1mg dose after three weeks, with durable response for up to 12 weeks.

“Treatment-resistant depression is a major public health challenge, affecting approximately 100 million people worldwide, and it is well understood that there is an urgent need for differentiated treatment options,” said Guy Goodwin, CMO. “This study together with the Phase 2b suggest the potential of COMP360 to provide rapid and durable clinical benefits from a single administration. We continue to explore the full profile of COMP360 in our ongoing Phase 3 clinical development program and we look forward to seeing the first phase 3 data from our COMP005 trial in the second quarter.”

FILAMENT REPORTS PHASE 2 PEX010 DATA: Filament Health (FLHLF) announced Monday data from an open-label phase 2 clinical trial studying the effects of its botanical psilocybin drug candidate, PEX010, for the treatment of alcohol use disorder at Psychiatric Centre Copenhagen. The results were published in the Journal of Psychopharmacology and found that a single 25mg dose of PEX010 was safe and effective in reducing alcohol consumption in AUD patients. The open-label phase 2 study investigated single-dose psilocybin therapy in 10 treatment-seeking adults with severe AUD. The treatment involved two preparation sessions, a high-dose psilocybin session, and two integration sessions. Alcohol consumption significantly decreased over the 12 weeks following the administration of PEX010. The percentage of heavy drinking days was reduced from 53.6% before receiving PEX010 to 16.1% at week 12 and drinks per day decreased by an average of 3.4 drinks over the 12-week follow up period. This was corroborated by reports of rapid and sustained reductions in craving and temptation and significant increases in self-efficacy. All participants completed the therapy course, and the safety profile was favourable with no serious adverse events.

“We are thrilled to announce positive results which support the efficacy of PEX010,” said Benjamin Lightburn, CEO. “These data reinforce our confidence in the potential of botanical psilocybin to help the millions of people suffering from substance use disorders like AUD. We look forward to advancing to the next stage of development.”

NUMINUS RECEIVES STATE CERTIFICATION APPROVAL: Numinus Wellness (NUMIF) announced Thursday that its Psychedelic-Assisted Therapy Training Program has been officially approved by the state of Colorado. This approval comes as part of Colorado’s Natural Medicine Health Act, which establishes a legal framework for the facilitation of psilocybin services by trained and licensed professionals. Numinus’ state-approved certification pathway includes coursework in psychedelic-assisted therapy fundamentals, psilocybin-specific training, trauma-informed care, and practical applications, along with clinical practicum placements to ensure hands-on experience.

“This is an exciting step forward for both Numinus and for the future of psychedelic-assisted therapy in Colorado,” said Michael Tan, CEO of Numinus Wellness. “We are committed to ensuring that practitioners receive the highest standard of training so they can provide safe, ethical, and transformative psilocybin-assisted therapy in accordance with Colorado’s regulations.”

OTHER PSYCHEDELIC STOCKS: Publicly-traded companies in the space include Algernon Pharmaceuticals (AGNPF), Allied Corp. (ALID), BetterLife (BETRF), Bright Minds Biosciences (DRUG), Entheon Biomedical (ENTBF), Enveric Biosciences (ENVB), Incannex Healthcare (IXHL), Mind Medicine (MNMD), MIRA Pharmaceuticals (MIRA), Mydecine Innovations (MYCOF), 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).