Key Takeaways; Psychedelic Sector

• Optimi Health Plans to Initiate Phase 3 Clinical Trial Evaluating MDMA Therapy for Individuals with PTSD 
• Eli Lilly Completed $2.8 Billion Acquisition of AtaiBeckley, Expanding its Mental Health Pipeline
• Definium’s Phase 3 Panorama Trial Delivered Positive Results for DT120 in Generalized Anxiety Disorder
• Psyence BioMed Established Texas Entity to Advance U.S. Ibogaine Development

Key Takeaways; Cannabis Sector

• High Tide Posted Record Q3 as Retail Growth Met German Expansion 
• Curaleaf and Aurora Cannabis Continue to Escalate Public Battle Over Takeover Bid and Share Dilution

Below is a weekly roundup of what happened this week in the cannabis and psychedelic sectors. In this ever-evolving landscape, we explore the major developments and groundbreaking initiatives happening among companies operating in these industries; from advancements in medical research, therapeutic applications to shifts in legal frameworks and current market trends.

Top Psychedelic Companies for Week

#1: Optimi Health

Optimi Health Corp. (NASDAQ: OPTH) announced plans to initiate a Health Canada-authorized Phase 3 clinical trial evaluating MDMA-assisted therapy for people with post-traumatic stress disorder (PTSD), with the study expected to begin in 2027.

In a press release, Optimi said the trial is expected to enroll up to 100 participants at multiple sites across Canada, with a focus on veterans and current or former frontline workers, including military personnel, police officers, paramedics, firefighters and healthcare workers.

According to the company, participants will receive Optimi’s synthetic MDMA HCl in two dosage formats during two supervised treatment sessions combining MDMA with psychotherapy. The sessions will be held several weeks apart, followed by clinical evaluations to assess treatment outcomes. The primary measure of efficacy will be changes in scores on the Clinician-Administered PTSD Scale, a widely used clinician-rated tool for measuring PTSD symptom severity.

Optimi CEO and co-founder Dane Stevens said the company is moving forward with the program alongside its recently announced Phase 2 trial of naturally derived psilocybin for major depressive disorder. “PTSD and major depressive disorder are large, underserved markets,” Stevens said, adding that veterans and frontline workers carry a disproportionate share of the mental-health burden.

The planned MDMA study represents another step in Optimi Health’s broader strategy of developing psychedelic-assisted therapies for potential registration. The company is also preparing a Phase 2 clinical trial of natural psilocybin for major depressive disorder, expected to begin in the first half of 2027.

Optimi currently manufactures GMP-grade MDMA and botanical psilocybin at its facilities in British Columbia. The company says its products are supplied to regulated clinical and therapeutic programs internationally, while psilocybin is also accessible in Canada through Health Canada’s Special Access Program.

#2: AtaiBeckley

Eli Lilly and Company (NYSE: LLY) completed its acquisition of AtaiBeckley Inc. (NASDAQ: ATAI), bringing the clinical-stage biopharmaceutical company’s psychedelic-inspired mental health pipeline under Lilly’s neuroscience business. The definitive acquisition agreement, which was announced in July, was approved by AtaiBeckley shareholders before closing.

AtaiBeckley has been developing rapid-acting neuroplastogens aimed at treating mental health conditions, with its lead program, BPL-003, focused on treatment-resistant depression (TRD). BPL-003 is a synthetic form of 5-MeO-DMT, administered intranasally, and is designed to provide rapid and potentially durable improvements in depressive symptoms.

The company’s pipeline also includes VLS-01, a buccal film formulation of DMT being evaluated in Phase 2b for TRD, and EMP-01, an investigational (R)-MDMA treatment for social anxiety disorder. BPL-003 had received Breakthrough Therapy Designation from the U.S. Food and Drug Administration and has entered Phase 3 activities.

“Treatment-resistant depression persists even after multiple treatment attempts, leaving millions of people still searching for relief,” said Carole Ho, Lilly’s executive vice president and president of Lilly Neuroscience. She said AtaiBeckley’s neuroplastogens could support a new treatment approach based on rapid-acting therapies rather than chronic dosing.

The acquisition expanded Lilly’s neuroscience pipeline into treatments designed to address underlying changes in synaptic plasticity, which is the brain’s ability to form and strengthen neural connections, rather than primarily targeting neurotransmitter levels.

Under the agreement announced in July, Lilly agreed to pay $6.75 per AtaiBeckley share in cash, representing an upfront equity value of approximately $2.8 billion. Additionally, under the agreement, shareholders may also receive up to $2.50 per share through a contingent value right tied to specified development and regulatory milestones for BPL-003 and VLS-01.

AtaiBeckley CEO and co-founder Srinivas Rao said the company’s goal has been to develop treatments that address psychiatric illness “at its biological root, not just its symptoms.” The acquisition, he added, is expected to give the programs access to Lilly’s resources and reach as they advance through clinical development.

With the transaction now complete, Lilly takes control of AtaiBeckley’s development programs as it seeks to advance new treatment options for patients with treatment-resistant depression and other mental health conditions.

#3: Definium Therapeutics

Definium Therapeutics, Inc. (NASDAQ: DFTX) reported positive topline results from its Phase 3 Panorama study evaluating DT120 Orally Disintegrating Tablet (ODT) in adults with generalized anxiety disorder (GAD). According to the company, the trial met its primary and key secondary endpoints, marking the company’s second positive Phase 3 study of DT120 in GAD and its third positive Phase 3 readout overall.

Definium reported that patients receiving a 100-µg dose of DT120 recorded a significantly greater reduction in anxiety symptoms than those receiving placebo. At Week 12, the least-squares mean change in Hamilton Anxiety Rating Scale (HAM-A) scores was -9.8 for DT120 compared with -4.7 for placebo, resulting in a placebo-adjusted difference of -5.1 points. Improvements were observed as early as day-2 and remained consistent throughout the post-treatment assessments.

The study also showed improvements across several secondary measures, including clinician-rated anxiety severity, response and remission rates. Additionally, the company said that DT120 was generally well tolerated, with most treatment-emergent adverse events described as mild to moderate, transient and concentrated around the dosing day. Definium reported no new safety signals, drug-related serious adverse events or suicidality signal.

“The Panorama results again met our high expectations and confirmed the unprecedented efficacy of DT120 in GAD,” said Rob Barrow, Definium’s CEO. He added that the results strengthen the company’s evidence base as it prepares for a pre-NDA meeting with the FDA and an anticipated New Drug Application submission in the first half of 2027.

The Panorama trial enrolled 245 adults across approximately 32 sites and evaluated a single dose of DT120 ODT followed by a 12-week double-blind treatment period. Participants could subsequently enter a 40-week open-label extension, during which additional doses could be administered based on symptom severity.

Definium is developing DT120, a proprietary formulation of lysergide (LSD), for GAD, major depressive disorder and post-traumatic stress disorder. The treatment has received FDA Breakthrough Therapy designation for GAD and MDD, with the company now moving toward regulatory discussions and a potential filing for approval.

#4: Psyence BioMed

Psyence Biomedical Ltd. (NASDAQ: PBM) established Texas Ibogaine Research Corporation (TIRC), a Texas-based subsidiary created to coordinate the company’s efforts to develop pharmaceutical-grade ibogaine for potential medical and research applications in the United States.

The company stated that TIRC is intended to serve as Psyence BioMed’s dedicated U.S. vehicle for ibogaine development, bringing together supply, manufacturing, regulatory and potential clinical development activities. Subject to definitive licensing agreements, the entity is expected to hold U.S. rights to pharmaceutical grade ibogaine developed by PsyLabs, in which Psyence BioMed holds an ownership interest.

The company plans to use TIRC to coordinate regulatory documentation, manufacturing arrangements and a potential future Investigational New Drug (IND) application. The Texas entity is also expected to serve as Psyence BioMed’s primary U.S. counterparty in discussions with federal agencies, state programs and potential clinical research partners.

Psyence BioMed CEO Jody Aufrichtig will also lead TIRC, while Dr. John Thorne has been appointed project lead. The company expects to support the new entity through its existing technical, legal, administrative and financial resources. “The United States is creating new momentum around rigorous, regulated ibogaine research,” Aufrichtig said. He added that TIRC was established to bring together ibogaine rights, pharmaceutical-grade supply and the company’s development strategy within a dedicated U.S. structure.

According to Psyence BioMed, the initiative follows recent U.S. policy and research developments involving ibogaine and other neuroplastogens. The company said its next steps include completing licensing arrangements, advancing regulatory discussions and developing manufacturing and potential clinical plans.

Top Marijuana Companies for the Week

#1: High Tide

High Tide Inc. (NASDAQ: HITI) (TSXV: HITI) delivered record financial results in the third quarter of fiscal 2026, with revenue reaching C$198.8 million for the three months ending July 31, up 33% year over year. Gross profit rose 32% to C$52.7 million, while adjusted EBITDA climbed 53% to a record C$16.2 million.

The company also reported C$8.7 million in income from operations and net income of C$12.7 million, compared with C$832,000 in the same quarter last year. Operating cash flow before changes in non-cash working capital reached C$11.9 million, while free cash flow stood at C$7 million.

High Tide said its Canadian retail business remained a key contributor. According to the company, its Canna Cabana loyalty program held a 14% share of the cannabis retail market in the provinces where it operates, excluding British Columbia, up from 13% a year earlier. The chain had 232 locations following the recent addition of four Ontario stores through the Northern Helm acquisition.

High Tide also stated that its customer engagement also continued to expand, with Canadian Cabana Club membership surpassing 2.73 million, a 27% increase from the previous year. Its ELITE membership also exceeded 186,000, representing 62% year-over-year growth.

Germany provided another significant source of momentum. High Tide reported that its majority-owned Remexian Pharma distributed a record 10.2 tonnes of medical cannabis during the quarter, up 62% year over year and 35% sequentially. The business generated C$38.2 million in revenue, compared with C$31.6 million in the previous quarter, while its market share reached 10.5% during the first six months following the acquisition.

High Tide also continued developing its proprietary cannabis products, expanding its Queen of Bud and Cabana Cannabis Co. white-label portfolio from 41 to 48 SKUs. The company said these products currently account for about 1.9% of its total brick-and-mortar cannabis sales.

Founder and Chief Executive Officer of High Tide, Raj Grover, said the results demonstrated the operating leverage the company had been building. “Our bottom line is now growing substantially faster than our top line,” he said, while adding that High Tide was approaching an annualized revenue run rate of C$800 million.

Looking ahead, High Tide reiterated its long-term goal of exceeding 350 Canadian retail locations and opening more than 20 stores during calendar 2026. The company also said it continues to assess opportunities in Europe and the United States while maintaining its focus on growth, profitability and cash generation.

#2: Curaleaf Holdings

The increasingly contentious takeover battle between Curaleaf Holdings, Inc. (TSX: CURA) (OTCQX: CURLF) and Aurora Cannabis Inc. (NASDAQ: ACB) (TSX: ACB) intensified this week, with the two companies trading fresh accusations over Aurora’s at-the-market (ATM) share issuance program.

On September 14, Curaleaf applied to the Alberta Securities Commission (ASC) for an expedited hearing seeking to halt Aurora’s use of its ATM program while Curaleaf’s takeover offer remains outstanding. Curaleaf alleges that continued share issuances dilute Aurora shareholders and make its offer more costly.

Curaleaf said Aurora had issued approximately 2.81 million shares at an average price of US$3.04 since Curaleaf first expressed interest in a transaction. According to Curaleaf, those issuances have diluted shareholders by approximately 4.9% over that period and increased the cost of its offer by more than US$11 million. Curaleaf estimates total dilution from the ATM program at approximately 10.8% since it was established in February.

“Every Share Aurora sells below the Offer price raises the same question: if management believes US$4.00 undervalues the company and the company has ample cash, why continue diluting its shareholders?” Curaleaf CEO Boris Jordan said.

Curaleaf argues that Aurora’s ATM program, which was announced months before the hostile bid, has become an obstacle for shareholders considering the proposed transaction. The company is asking the ASC to stop further issuances while its offer remains open.

Aurora rejected the allegations, arguing that the ATM program predates Curaleaf’s takeover attempt and was established as part of its longer-term growth strategy. The company said the program was intended to provide capital for strategic and accretive investments, including acquisitions and expanded cultivation capacity.

“Curaleaf is attempting to spin a story that simply does not align with the facts,” Aurora CEO Miguel Martin said. He added that the ATM program “was never designed as a response” to Curaleaf’s bid and pointed to Aurora’s recent UK acquisitions as an example of how the funds have been deployed.

Aurora also turned Curaleaf’s financial arguments back on its bidder, highlighting what it says is more than US$1 billion of debt at Curaleaf, including US$500 million carrying an 11.5% interest rate. Aurora said shareholders should instead focus on whether Curaleaf’s offer adequately reflects the value of Aurora’s business, assets and future opportunities. “The Board’s responsibility is to maximize value for Aurora shareholders, not to make Aurora easier or cheaper for Curaleaf to acquire,” Martin said.

The dispute is the latest chapter in a takeover battle that began publicly in August. Curaleaf is offering Aurora shareholders US$4.00 per share, comprising 0.3463 Curaleaf shares and US$0.75 in cash, subject to a US$5.00 cap on the value of the consideration. Curaleaf has described the proposal as representing a 45% premium on Aurora’s unaffected trading price.

However, Aurora’s board and special committee unanimously recommended that shareholders reject the offer and take no action. Aurora argues that the proposal undervalues its international medical cannabis platform, cash position and EU-GMP assets, while Curaleaf maintains that its offer provides immediate value alongside participation in the future of a larger cannabis business.