Psychedelic: atai Life Sciences, Cybin report earnings results

In this week’s “Psychedelic,” The Fly’s recurring series focused on psychedelic stock news, The Fly looks back on earnings, a Fast Track designation and a FDA approval.

FIRMS REPORT EARNINGS RESULTS: On Wednesday, Cybin (CYBN) reported a first quarter loss per share of ($1.10), which compared to a loss per share of (54c) for the same period last year. Cash totaled $118.7M as of June 30. Cash flows used in operating activities were $29.5M for the quarter ended June 30, compared to $19.9M in the same period last year.

“With our recently announced funding agreement in place, we are well positioned to continue advancing our lead clinical programs, CYB003 and CYB004, through multiple inflection points,” said Doug Drysdale, CEO. “Gaining European CTA approval and MHRA approval to commence EMBRACE in the UK has enabled us to expand our multinational Phase 3 PARADIGM program evaluating CYB003 for the potential adjunctive treatment of major depressive disorder. PARADIGM is a significantly larger program than the completed Phase 2 study, with anticipated combined enrollment of approximately 550 participants. Our Phase 3 studies will evaluate the potential clinical benefits of CYB003 in patients living with moderate to severe MDD, and whose symptoms are uncontrolled with existing antidepressant treatment. Our Phase 2 study evaluating CYB004 in generalized anxiety disorder is expected to complete patient enrollment this month. Cybin is in a strong position to advance our programs and continue our work to deliver innovative therapies to address some of the most challenging mental health disorders we face today and is helping to build momentum across the sector – both from a clinical and regulatory perspective.”

On Monday, Filament Health (FLHLF) reported Q2 revenue of $259,013 and cash used in operating activities of $592,136. The company also announced cash and cash equivalents of $679,972.

“This quarter, we took deliberate steps to position Filament Health for long-term growth, including streamlining our public listings to reduce costs and increase operational efficiency. We advanced our clinical and licensing portfolio with two significant developments: securing an exclusive global license for intellectual property and data usage from a Phase 2 study of psilocybin as a treatment for cocaine use disorder, and receiving approval to initiate a Phase 2 trial of our botanical psilocybin drug candidate, PEX010, for the treatment of prolonged brief disorder in Sweden,” said Benjamin Lightburn, CEO. “These achievements reflect our commitment to pioneering psychedelic drug development while managing our resources strategically, ensuring that we are well-positioned to continue delivering on our mission. The demand for botanical psychedelic treatments continues to grow as noted by the recent approval of PEX010 for compassionate use in Germany for administration to a patient suffering from treatment-resistant depression – the EU’s first ever approval of psilocybin for compassionate use.”

On Thursday, atai Life Sciences (ATAI) reported a Q2 loss per share of (14c) on revenue of $719,000, which compared to analyst loss per share estimates of (12c) and revenue of $273,000 for the same period last year. As of June 30, the company had cash, cash equivalents and short-term securities of $95.9M compared to $72.3M as of December 31. With an additional $50M gross proceeds from committed funding announced in July, the company expects its cash, cash equivalents, short-term securities, public equity holdings, and digital assets to fund operations for the combined company into 2H27.

“The first half of 2025 has been transformational for atai as we continue to advance our mission,” stated Srinivas Rao, CEO. “The planned strategic combination with Beckley Psytech is expected to solidify our position as the global leader in the psychedelic mental health space. By combining our experienced teams and psychedelic expertise as well as adding a late-stage, clinically-validated asset like BPL-003 to our pipeline of wholly owned psychedelic programs – which includes VLS-01 and EMP-01 in Phase 2 clinical development – we are accelerating our ability to bring novel, effective treatments to patients in need. The recent positive Phase 2b results for BPL-003 highlight its potential as a differentiated, fast-acting, and durable option for treatment-resistant depression that aligns with the established 2-hour interventional psychiatry treatment paradigm. With multiple clinical milestones on the horizon, we are confident in our ability to drive long-term value for both patients and shareholders.”

ADDITIONAL EARNINGS: Enveric Biosciences (ENVB) reported Q2 results on Thursday with a loss per share of (97c), which compared to a loss per share of ($3.72) for the same period last year. As of June 30, Enveric had cash and cash equivalents of $2.8M.

“The second quarter of 2025 represented a period of focused execution across all key areas of our business, most notably with the advancement of EB-003, our lead drug candidate,” said Joseph Tucker, CEO. “We disclosed important new data demonstrating that EB-003 engages both the 5-HT₂A and 5-HT₁B receptors through a dual mechanism of action. We believe this receptor pairing forms the foundation for a novel pharmacological class. With this discovery, we believe EB-003 has emerged as a first-in-class therapeutic candidate with a dual mechanism that represents a unique therapeutic target with real-world clinical utility… Looking ahead to the remainder of 2025 and into 2026, we remain sharply focused on filing an Investigational New Drug application for EB-003 and preparing for its first-in-human study. We also continue to benefit from ongoing dialogue and growing interest from established pharmaceutical companies with a strategic focus in neuropsychiatry, which underscores the increasing relevance of our platform in a field that has lacked innovation for far too long.”

On Monday, Bright Minds Biosciences (DRUG) reported a Q2 loss per share (42c), which compared to a loss per share of (13c) for the same period last year.

The company said, “The company incurred a net loss of $2,900,775 for the six months ended March 31, 2025, compared to a net loss of $2,258,408 for the comparable period. The company expects to continue to raise additional capital through dilutive equity financings and seek additional investment opportunities to further the development of therapeutics to improve the lives of patients with certain severe and life-altering diseases. The company may also pursue strategic partnerships and licensing opportunities with collaborators, which may or may not generate non-dilutive funds.”

NRX GRANTED FDA FAST TRACK DESIGNATION FOR NRX-100: NRx Pharmaceuticals (NRXP) announced Monday that the U.S. Food and Drug Administration has granted Fast Track designation to NRX-100 for the treatment of suicidal ideation in patients with depression, including bipolar depression. This designation for NRX-100 as a standalone drug is a 10-fold expansion of the addressable population for NRX-100, compared to the designation granted in 2017 for NRX-100 in combination with NRX-101 for treatment of Suicidal Bipolar Depression. In granting the designation, the FDA made the determination that NRX-100 has the potential to address an unmet medical need, based on an assessment of the preliminary data contained in the request. This determination of unmet medical need aligns with the eligibility requirements for the Commissioner’s National Priority Voucher Program and for the FDA’s Accelerated Approval Program. The company has applied for a CNPV, which has the potential to substantially shorten the review cycle for NRX-100. Several well-controlled trials submitted to FDA in support of the designation demonstrated a clinically meaningful and statistically significant reduction of suicidal ideation. In a Columbia University study licensed by NRx, suicidal patients treated with intravenous ketamine demonstrated a 55% response compared to a 30% response to active comparator. In a trial sponsored by the Government of France and licensed by NRx, 63% of patients achieved full remission from suicidal ideation in three days compared to 31% of those who received placebo.

“We thank FDA for its thoughtful review of our Fast Track designation request, and believe this regulatory determination is a significant step forward in our goal to address the national crisis of suicide among soldiers, first responders, veterans, and civilians alike.” said Jonathan Javitt, CEO. “Large-scale government-supported trials have demonstrated a robust and statistically significant reduction in suicidal ideation and depression with administration of ketamine. This drug was also proven to be non-inferior to electroshock therapy in treating depression without the negative side effects of ECT. We look forward to working closely with the FDA in our quest to Bring Hope to Life.”

Additionally on Friday, HOPE Therapeutics, a wholly-owned subsidiary of NRx Pharmaceuticals, announced it has received final clearance and approval from the Florida Agency for Health Care Administration to proceed closing of the Dura Medical acquisition, in connection with its change of ownership applications. Dura is revenue generating and EBITDA positive. Dura Medical was founded in 2018 to offer a precision approach to treating mental health and chronic pain on the west coast of Florida.  The clinics leverage the latest interventional psychiatry procedures, including Ketamine Infusion Therapy, Transcranial Magnetic Stimulation, Spravato and Stellate Ganglion Blocks, augmented by traditional psychiatry and therapy to provide a full continuum of care for people with depression, suicidality, PTSD, anxiety, and related disorders.

PHARMATHER RECEIVES FDA APPROVAL FOR KETARX: PharmaTher Holdings (PHRRF) announced Monday that the U.S. Food and Drug Administration has approved the company’s ketamine product on August 8 for its indicated uses in surgical pain management. The FDA’s approval of the company’s ketamine product, KETARx, provides a strong foundation for expanding the development of ketamine across diverse therapeutic areas within the company’s product pipeline. These areas include mental health conditions like depression, neurological disorders such as Parkinson’s disease and Amyotrophic Lateral Sclerosis, and the management of rare or chronic pain, including Complex Regional Pain Syndrome.

Fabio Chianelli, CEO, said, “Today marks a new chapter for PharmaTher. With FDA approval for ketamine now in hand, we are closer to realizing our goal of becoming a global leader in ketamine-based pharmaceuticals. This historic FDA approval for PharmaTher is a testament to years of dedicated development, signalling a new era of growth. We remain steadfast in our mission to harness the pharmaceutical potential of ketamine for a range of mental health, neurological, and pain disorders.”

MIRA SAYS KETAMIR-2 MANUSCRIPT ACCEPTED FOR PUBLICATION: MIRA Pharmaceuticals (MIRA) announced Tuesday the acceptance of a second peer-reviewed manuscript describing its lead oral drug candidate, Ketamir-2, in Frontiers in Pharmacology. The newly accepted publication reports that Ketamir-2 outperformed ketamine, pregabalin, or gabapentin, depending on the comparator used-in restoring sensory function and reversing pain behaviors across two gold-standard rodent models of neuropathic pain. The findings build on MIRA’s first publication characterizing Ketamir-2’s clean pharmacology and favorable safety profile and align with the company’s plan to initiate a Phase 2a trial in neuropathic pain by year-end 2025. Key findings include in the Chung Model in male rats, Ketamir-2 restored sensory thresholds toward baseline, while ketamine, tested as the comparator, showed no measurable benefit. In female rats, Ketamir-2 outperformed both pregabalin and gabapentin, delivering greater and more consistent restoration of normal sensory responses. In Paclitaxel-Induced Neuropathy in mice, gabapentin was the sole comparator in this chemotherapy-induced neuropathy model. Ketamir-2 produced more complete normalization of pain sensitivity in both male and female cohorts, while gabapentin provided only partial or inconsistent relief. For efficacy across genders and species, the company found despite differences in baseline pain sensitivity between male and female animals, Ketamir-2 demonstrated clear and significant therapeutic benefit in every cohort tested.

“The acceptance of this second peer-reviewed publication is another important milestone for our Ketamir-2 program,” said Erez Aminov, CEO. “The data clearly demonstrate superior and more consistent pain relief compared to leading neuropathic pain drugs, within the specific models tested. This provides additional confidence as we advance Ketamir-2 toward Phase 2a clinical evaluation and continue to explore its potential in broader CNS applications.”

OTHER PSYCHEDELIC STOCKS: Publicly-traded companies in the space include Algernon Pharmaceuticals (AGNPF), Allied Corp. (ALID), BetterLife (BETRF), Compass Pathways (CMPS), Clearmind (CMND), GH Research (GHRS), Incannex (IXHL), Mind Medicine (MNMD), Numinus Wellness (NUMIF), Pasithea Therapeutics (KTTA), PharmAla (MDXXF), Psyence Biomedical (PBM), Psyence Group (PSYGF), Relmada Therapeutics (RLMD), Revive Therapeutics (RVVTF), SciSparc (SPRC), Seelos Therapeutics (SEEL) and Silo Pharma (SILO).