Initiated in Q2. Unregistered at the end of Q3.

Lead Story

AtaiBeckley told the SEC in August that its BPL-003 Phase 3 activities were initiated in the second quarter. The third ends tomorrow. There is no BPL-003 Phase 3 on ClinicalTrials.gov or CTIS, under any sponsor.

The words are the company's. The Q2 10-Q lists "BPL-003 Phase 3 activities in treatment-resistant depression ("TRD") have been initiated" and, in the cost discussion, development "which have initiated Phase 3 activities in the second quarter of 2026." The phrase "first patient" appears nowhere in the filing.

Registry silence has arithmetic. If ReConnection has a US site or an IND, the FDA's permission to test a drug in the US, US law requires registration within 21 days of the first patient, and ClinicalTrials.gov has 30 days to post it. Fifty-one days at the outer limit. Count back from today and any patient enrolled before 9 August would be public by now. Our view is that the rule binds: the Phase 2b ran US sites and the FDA reviewed the Phase 3 plan.

That leaves two readings. A record is in the queue, which needs a first patient in the back half of Q3 on a programme "initiated" in Q2. Or there is no patient. Our view, and it is a view, is that no patient has been enrolled. The test is public. If a record appears in October, its start date will tell us which of us was right.

Fair to the other side: the deal closed on 11 September, in the middle of the quarter, and a change of control can stall site contracts and ethics approvals. Lilly's systems own the programme now.

And the company that said "initiated" no longer has to say anything. Its Form 15 of 21 September suspended its reporting duty the day it was filed.

Europe is downstream of this trial. Any European filing for BPL-003 rests on ReConnection data. Every quarter it slips, Europe slips with it, and nobody is obliged to tell Europe.

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Eight member states in four days

Same company, same month, other end of the pipeline. Lilly's brenipatide COPD Phase 2 was authorised by eight member states between 15 and 18 September: Czechia, Denmark, France, Germany, Poland, Hungary, Austria, Romania. Forty-eight sites, 265 European patients planned, the eighth brenipatide trial on CTIS. Lilly's European engine is not the constraint. BPL-003 is not on it.

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Deal tape

Beckley Psytech Limited's board changed on closing day. Companies House shows four directors out and two in, every one effective 11 September, the closing date, filed 15 to 17 September.

One new row. PsyHab, a Marie Skłodowska-Curie grant of EUR 191,918.16 to Narodni ustav dusevniho zdravi in Czechia, started 1 September. Two years, habenula and raphe circuitry.

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Data point

EUR 191,918. That is the European public money that started work in psychedelic medicine this month. The American private money that closed in the same month, on the closing 8-K's own figure: $3.8 billion. We print the two numbers and let them sit.

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Signal

Cybin becomes Helus Pharma on 1 October. 107 shareholders holding 63.58% of the shares voted, 99.3% in favour. The name changes. The registry does not: two CYB003 Phase 3 records, sponsor of record Cybin IRL Limited, both updated 25 September, the main trial recruiting across Czechia, Germany, Greece, Ireland, Poland and the UK. We track the registry, not the letterhead.

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Europe: checked, nothing new

EMA's September list of applications under evaluation, extracted 4 September, carries 90 applications and no psychedelic. CHMP next sits 12 to 15 October. Two European psilocybin trials carried CTIS updates this week, PsyPal at UMC Groningen and a Phase 2 in Prague. CTIS does not publish what changed, so neither is a story yet.

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Failed checks, not zeros

Six channels did not answer this week: AtaiBeckley's investor site, Lilly's investor site, Compass's news index, NICE guidance in development, ZIN, and the G-BA procedures list. The first three were read through EDGAR instead. The last three stay failed, and a failed check is not a zero.

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Ledger

Twelve carried in; this issue makes the thirteenth. Nothing scored this week.

Issue 3 resolves tomorrow. It calls AtaiBeckley reporting a first BPL-003 Phase 3 patient dosed in Q3. Four channels read: AtaiBeckley's SEC filings to the Form 15, Lilly's SEC filings, ClinicalTrials.gov, CTIS. Nothing. Two channels failed: AtaiBeckley's investor site and Lilly's. Our view: on every channel we can read, this is a miss, and the company that would have made the announcement no longer has to make any. It scores in Issue 17, whatever it is.

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The call

Compass discloses completion of its rolling NDA submission for COMP360, the FDA marketing application, on or before 31 December 2026.

One company guided Q2 initiation, said "initiated", and has nothing registered at the end of Q3. The other has said Q4 six times since February and never moved the quarter. We back the second.

Falsifier: no Compass press release or SEC filing dated on or before 31 December 2026 states that the NDA submission is complete. Scores in the first January issue.

Resolves 2026-12-31. Logged as call 16 on the ledger.

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Corrections

None this week.