💸 The Tape

COMPASS Pathways plc (NASDAQ: CMPS) used its recent investor webinar to deliver what management clearly views as a defining moment: positive results from two Phase III trials—COMP005 and COMP006—of COMP360 psilocybin for treatment-resistant depression (TRD). Combined with its prior Phase IIb data, the company says it has now met its primary endpoint “three for three” across a dataset exceeding 1,000 participants.

For a field that only recently escaped regulatory exile, that’s not trivial.

The Clinical Case: Rapid Onset, Durability Signals

CEO Kabir Nath framed the opportunity around a substantial unmet need—over 4 million U.S. adults estimated to suffer from TRD annually. The company’s argument is straightforward: conventional antidepressants often fail this population, and currently approved options are limited.

Chief Medical Officer Dr. Guy Goodwin detailed the pivotal trial designs. COMP005 evaluated a single 25 mg dose versus placebo in U.S. patients, with a primary endpoint at six weeks. COMP006 expanded geographically (U.S., Europe, Canada) and compared 25 mg, 10 mg, and 1 mg doses administered twice, three weeks apart. Importantly, the 1 mg dose functioned as an active comparator rather than an inert placebo—intended to reduce unblinding and better isolate pharmacologic effect.

The company emphasized what it calls “rapid onset.” According to management, treatment effects were observed the day after dosing in COMP005 and remained statistically significant through week six. In COMP006, the 25 mg arm separated statistically from the 1 mg comparator at all post-baseline time points.

Durability is where the narrative gets more nuanced. Newly presented COMP005 Part B data extended follow-up to 26 weeks. Management described “numerical separation” throughout that period, with many retreatments occurring between weeks 10 and 14. A subset of remitters reportedly sustained remission to week 26 after a single administration. Over 40% of those receiving a second 25 mg dose achieved remission after the second treatment.

In COMP006, 39% achieved a clinically meaningful MADRS reduction at week six, compared to 25% in COMP005. However, the week-six effect size of -2.5 points in COMP006—while statistically significant—falls below the commonly referenced three-point threshold often cited for clear clinical relevance. Goodwin noted that 1 mg likely performed better than an inert placebo would have, potentially compressing the observed difference.

Translation: the efficacy signal appears real, but magnitude and durability will remain points of regulatory scrutiny.

Safety Profile: No New Signals in >1,000 Patients

Across COMP004/005/006, management reported no new safety signals. Most adverse events occurred on dosing day and resolved within 24 hours.

Serious adverse events of suicidal ideation were reported at under 1%, with one suicidal behavior SAE occurring in the 1 mg arm of COMP006. The independent DSMB reportedly found no meaningful imbalance between arms. No attempted or completed suicides have been reported in the studies to date.

Blood pressure elevations—expected for the drug class—were described as transient and comparable to moderate exercise. In short, management characterized COMP360 as “generally well tolerated” under supervised administration conditions.

The key qualifier, of course, is that these are monitored, clinical settings with structured psychological support. Real-world scalability remains a future operational challenge.

Regulatory Path: Rolling NDA, Breakthrough Leverage, DEA Rescheduling

COMPASS has submitted its Phase III data to the FDA and is pursuing a rolling NDA submission strategy. Management indicated the agency has shown openness to an “aggressive filing strategy,” potentially supported by Breakthrough Therapy designation.

The remaining gating item is 26-week COMP006 data expected in early Q3. Once included, the company believes the NDA package will be complete.

If approved, DEA rescheduling will be required before commercial launch. Management noted that the DEA typically has 90 days post-FDA approval to reschedule, followed by necessary state-level adjustments.

Chief Commercial Officer Lori Englebert emphasized readiness planning, citing over 7,000 U.S. interventional psychiatry sites already equipped for multi-hour monitored treatments like esketamine (Spravato). The implicit message: infrastructure exists; COMP360 could plug into it.

Bottom Line

COMPASS has assembled a sizable Phase III dataset with statistically robust signals and a safety profile that, on paper, appears manageable in supervised settings. The company is now shifting from clinical validation to regulatory execution and commercial preparation.

The remaining questions are less about whether psilocybin “works” and more about magnitude of effect, durability, scalability, reimbursement, and regulatory pacing.

For a company that has staked its identity on medicalizing psychedelics, this is the moment where science meets the FDA—and, ultimately, the real-world healthcare system.

📈 Dog Walkers

$OGI ( ▼ 1.55% ) Makes Major EU Acquisition

Organigram Global Inc. (NASDAQ: OGI; TSX: OGI) has decided that exporting flower into Europe is good—but owning the distribution engine might be better.

The company announced a definitive agreement to acquire Berlin-based Sanity Group GmbH in a deal that could reach €227 million if performance targets are met. The structure is classic growth-market M&A: €113.4 million in upfront consideration—€80 million in cash and €33.4 million in Organigram shares—plus an earnout of up to €113.8 million tied to financial performance over the 12 months post-close.

The equity portion of the upfront consideration is priced at C$3.00 per share—a 71% premium to Organigram’s February 17 closing price—while earnout shares will be priced off a 20-day VWAP, with a C$3.00 floor and C$4.00 cap. Translation: vendors are incentivized to scale quickly, and Organigram is signaling conviction.

Why Sanity?

Sanity Group has quietly become one of Europe’s most credible cannabis operators. Founded in 2018 and headquartered in Berlin, the company spans medical cannabis, Swiss recreational pilot projects, and wellbeing products.

The growth curve is difficult to ignore:

• €9 million in net revenue (2023)

• €19 million (2024)

• €60 million (2025), including €19 million in Q4 alone

Gross margins have climbed from 15% in 2023 to 47% in 2025. Management also claims positive EBITDA for 2025. Market share in Germany has reportedly improved from #5 to #2 in just 12 months.

Germany is the real prize. Following 2024 reforms, the German medical cannabis market exceeded €2 billion in 2025 and is forecast to surpass €4.5 billion by 2028. Patient penetration is expected to approach ~2% of the population—putting it on par with mature medical markets like Israel and Australia.

For Organigram, which already dominates Canadian adult-use categories, Germany represents the largest federally legal medical market outside Canada—and arguably the most strategically important one in Europe.

Strategic Logic: From Exporter to European Hub

This is less about incremental sales and more about vertical positioning.

Organigram has been exporting into Europe. With Sanity, it gains:

• A vertically integrated European “hub”

• Deep regulatory and medical-market expertise

• Access to Switzerland’s two legal cannabis specialty stores (pilot projects)

• Near-term expansion plans into the UK, Poland, and Czechia

• Established supply-chain partnerships

It also gains leadership. Sanity CEO Finn Age Hänsel brings European operational and regulatory experience that would take years to replicate organically.

From Organigram’s perspective, this is a margin play. Selling higher-margin Canadian flower into Europe is attractive—but capturing distribution, branding, and regulatory positioning increases value capture across the chain.

Add in Organigram’s Product Development Collaboration (PDC) IP and you have a two-way exchange: European distribution plus Canadian R&D muscle.

Financing and the BAT Factor

The acquisition is expected to be funded via:

• Cash on hand

• A new credit facility

• A C$65.2 million equity investment from British American Tobacco p.l.c. (BAT)

BAT’s continued capital support underscores something institutional investors increasingly recognize: cannabis is evolving into a global regulated consumer category, and large strategic partners want optionality.

Accretion and Positioning

Organigram frames the deal as financially accretive and scale-enhancing. With Sanity already EBITDA positive and margins expanding rapidly, the thesis is that integration plus volume leverage will enhance profitability rather than dilute it.

Post-close, Organigram would:

• Retain its #1 Canadian adult-use market share position

• Become a top-tier player in Germany’s medical cannabis market

• Establish a credible European operating platform

In short, this isn’t just a market entry—it’s a market stake.

The Bigger Picture

European cannabis reform is uneven, politically sensitive, and jurisdictionally complex. But Germany’s medical program is real, scaling, and federally legal. Switzerland’s pilots are progressing. The UK, Poland, and Czechia are expanding medical frameworks.

For years, Canadian LPs chased U.S. optionality. Organigram is now leaning into Europe—where federal legality already exists.

If the integration executes cleanly and German growth continues at current velocity, this acquisition could look less like a bold bet and more like a timely pivot.

And in a global cannabis market that increasingly rewards scale plus regulatory sophistication, timing may matter as much as price.

$CBSTF ( ▼ 1.7% ) Extends Forebearance

The Cannabist Company Holdings Inc. has secured a modest but meaningful extension from its lenders, as the ad hoc group of noteholders agreed to prolong the existing forbearance period on the Company’s 2028 senior secured notes.

The extension pushes the standstill deadline to February 20, 2026, giving the multi-state operator additional runway as it works through ongoing liquidity discussions. The agreement applies to both the Company’s 9.25% Senior Secured Notes due December 31, 2028 and its 9.00% Senior Secured Convertible Notes due the same date.

In practical terms, the forbearance means the participating noteholders will continue to refrain from exercising their rights and remedies under the governing indenture and applicable law during the extended window. That includes holding off on acceleration or enforcement actions that could otherwise follow from covenant breaches or missed payments.

This is not a permanent fix. It is, however, a signal that creditors remain engaged and willing to negotiate rather than force an immediate restructuring event. For companies in capital-intensive sectors like cannabis—where access to traditional bank financing remains constrained—cooperation from secured lenders can be the difference between a controlled workout and a disorderly outcome.

The extension also underscores the leverage dynamic at play. The forbearance group represents a significant portion of the outstanding Notes, and their willingness to continue discussions suggests there may still be a viable path toward a broader recapitalization, asset monetization, or other strategic alternative.

From a capital markets perspective, the clock is still ticking. Each incremental extension preserves optionality but also reflects the urgency of arriving at a durable solution. Investors will be watching closely for signs of a comprehensive restructuring framework, whether through amendments, exchanges, asset sales, or a more formal balance sheet reset.

For now, the headline is simple: more time. In distressed credit situations, time is both an asset and a liability. How effectively management deploys this latest extension will likely determine whether the Company stabilizes its capital structure—or faces more consequential measures down the line.

🗞️ The News

📺 YouTube

Investors Watch Rescheduling Momentum As Price Action Slows | TTB Powered by Flowhub

What we will cover:

✅ On today’s episode of TDR Trade to Black presented by Flowhub, Shadd Dales and Anthony Varrell talk through four cannabis policy stories and what they could mean going forward.

A former White House drug czar is criticizing efforts to reschedule marijuana, calling cannabis a gateway drug and arguing the move is the wrong direction. We discuss the political backdrop, where rescheduling actually stands, and whether comments like this influence the broader federal conversation.

In Florida, the marijuana legalization campaign is asking the state Supreme Court to restore 71,000 ballot signatures that were invalidated by officials. The outcome will likely determine whether adult-use legalization gets another path to voters in a major state.

Pennsylvania lawmakers are also weighing legalization, but there’s growing debate around taxation. An argument being made: if cannabis is taxed too aggressively from day one, the legal market struggles to compete. We look at how other states handled this and what Pennsylvania may learn from those examples.