Europe is in the trial Helus hasn't dated.

Title: Europe is in the trial Helus hasn't dated.
Subtitle: EMBRACE, the CYB003 Phase 3 recruiting in Greece, Ireland and Poland, moved its primary completion date to June 2027 on Monday. Eleven of its 79 listed sites are withdrawn. The registry says what moved. It does not say why.

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Lead Story

EMBRACE, the CYB003 Phase 3 authorised in five EU member states, moved its primary completion date on Monday. When we read the record on 31 August it said 18 March 2027. It is now 7 June 2027, posted 5 October, four days after Cybin became Helus Pharma. Eighty-one days.

The site list tells a second story. Helus told shareholders EMBRACE would run at "approximately 60 clinical sites". ClinicalTrials.gov lists 79 entries: 43 in the US, 13 in the UK, 18 across Czechia, Germany, Greece, Ireland and Poland, 5 in Australia. Fifty-two are recruiting. Eleven are marked withdrawn. Nine of them American, one in Białystok, one in London.

One correction before the argument. Issue 16 called this record "the main trial". It is the second. APPROACH is the first: 223 participants, enrolment complete, topline guided for Q4 2026 in seven filings since June. EMBRACE has no guided date for anything. "Enrollment is underway" is the whole of it.

The obvious reading is that patients are coming slower than planned and withdrawn sites are the cost. We are not printing that as fact. The registry publishes a date and a site list. It does not publish a reason, and the version history that would show which update moved the date would not open for us. What the record does say: eleven withdrawn sites and a later date, in the same record. The registry does not date a withdrawal.

Europe sits inside this. The five member-state decisions of 18 to 22 September sit on CTISThe Clinical Trials Information System, or CTIS, is the European Union's single portal for applying to run a clinical trial and for publishing it, and each record lists the member states whose regulator has taken a decision on the trial and the sites in each., the EU trial register. They are one substantial modification, a change to an authorised trial that each member state approves separately. Filed 15 June, authorised in Ireland first and Poland last. CTIS does not publish what a modification changed. Authorised in five states, recruiting in three: Greece, Ireland and Poland. Every Czech and German site is not yet recruiting.

The concession: if APPROACH alone carries the filing, eighty-one days on EMBRACE changes nothing about when CYB003, a deuterated psilocin analogue, reaches a regulator. Our view is that it does not carry it alone. Helus's own filings call EMBRACE the second pivotalA pivotal trial, sometimes called a pivotal study, is industry shorthand rather than a regulatory term: it means a trial a company intends to serve as one of the adequate and well-controlled investigations that support an approval decision., and pivotal is a statement of intent to use the trial for approval.

So the European trial is the one without a date, and it is the one that moved. Primary completion is the registry's estimate of when the last patient finishes the primary endpointThe primary endpoint, called the primary variable in regulatory guidance and sometimes the primary outcome measure, is the single measurement a trial is designed and powered to answer, fixed in the protocol before anyone is unblinded.. It is the only clock Europe has on this drug, and it just lost eighty-one days.

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Signal

Lilly is now the registered controlling party of Beckley Psytech Limited. Two Companies House filings of 29 September: Eli Lilly and Company becomes a person with significant control from 21 September, AtaiBeckley Inc. ceases to be one. The UK sponsor of record on every BPL-003 registry entry answers to Indianapolis on paper, ten days after closing.

NCT07775300, Lilly's brenipatide Phase 3 in major depressive disorderMajor depressive disorder, or MDD, is the clinical diagnosis of depression itself, the broad population from which treatment-resistant depression is drawn once two adequate courses of antidepressants have failed., the broad depression diagnosis rather than the treatment-resistant one, went RECRUITING on 1 October. All 35 of its sites in Germany, Greece, Poland and Spain read not yet recruiting. Three of ten UK sites are open. Call 11 asks for RECRUITING plus at least one of Germany, Greece, Poland, Spain or the United Kingdom on the record on 31 December. On track, and the site list says recruitment in the four EU states has not begun.

Helus Pharma, 1 October. The 6-K confirms the name. Both registries still say Cybin IRL Limited, so the sponsor of record did not change. Only the parent did.

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Data point

Eleven. Sites marked withdrawn on the EMBRACE record, the one trial Helus has not put a date on.

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Regulator watch

EMBRACE, five decisions in five days on CTIS: Ireland 18 September, Germany, Greece and Czechia 21 September, Poland 22 September, application 81754. What was modified is not published. A Spanish esketamine Phase 3 record, CESAR, was updated on 30 September; CTIS does not say what changed, so it is not a story yet. CHMPThe Committee for Medicinal Products for Human Use, or CHMP, is the European Medicines Agency committee that assesses a marketing application and issues the scientific opinion the European Commission then turns into an EU-wide authorisation., the European Medicines AgencyThe European Medicines Agency, or EMA, is the European Union's central medicines regulator: through the centralised procedure it evaluates whether a medicine may be sold across the EU and EEA, and it has no say in what any country then pays for it. committee that recommends approvals, sits 12 to 15 October.

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Failed checks, not zeros

Every company investor page failed this week and was read through EDGAR instead. Two brenipatide IBS records on CTIS returned empty on re-check, so the Issue 12 call was only partly re-verified. The NCT06793397 version history returned a 403. Calls 8, 10 and 13 were not re-checked this week. A failed check is not a zero.

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Ledger

Twelve carried in; this issue makes the thirteenth.

Issue 3 scores. The call as Issue 3 printed it, its dash replaced by a comma: "AtaiBeckley will report its first BPL-003 Phase 3 patient dosed in Q3 2026, after 30 June, before 30 September." Miss. The quarter closed with no such report on any channel that answered: eleven tried on 1 October, eight answered, one partial, two failed. No falsifier was printed in Issue 3, and we did not write one in afterwards.

Issue 2 called no first patient by 30 June and hit. Issue 3 called a first patient in Q3 and missed. Both were scored on what was public, not on what was guided. From here every call is pinned to a registry or filing field. Today's is.

The board: two hits, one miss, one void, twelve open.

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The call

On 31 March 2027 the primary completion date on NCT06793397 is still 7 June 2027.

Eleven withdrawn sites and a later date. We think June holds.

Falsifier: any primary completion date later than 7 June 2027 on the record on 31 March 2027. An earlier date is a hit. Scores in the first April issue.

Resolves 2027-03-31. Logged as call 17 on the ledger.

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Corrections

Issue 16 called NCT06793397 "the main trial". It is EMBRACE, the second of Helus's two pivotal CYB003 trials. APPROACH is the first.