Gate Conditions Register

Vitalis Therapeutics Inc. — The permanent record of conditions attached to gate outcomes in the VitaFlow (VTX-401) program: what was issued, why, the verification method fixed at issue, progress, and closure evidence. Status at 15 October 2026.

Conditions issued

Closed

Open

At risk

Contents

Purpose
What a Condition Is, and What It Is Not
Register
Condition Records
What Makes a Verification Method Adequate
What the Register Shows
When a Condition Cannot Be Closed

1. Purpose

This register records every condition attached to a gate outcome in the VitaFlow (VTX-401) program. Three conditions have been issued, all at Gate 4 on 30 June 2026, with the recorded outcome GO WITH CONDITIONS (5-0-1).

Each entry carries the four elements required by §7 of the Development Committee Charter: a named single owner, a due date, a verification method, and the criterion or risk it addresses.

The verification method is fixed at issue and cannot be renegotiated at closure. This is the provision the register exists to enforce. A condition whose evidence standard can be softened when it comes due is not a condition; it is a note. Because the original wording is recorded here alongside whatever is eventually offered as closure evidence, the two can be compared by anyone — which is what makes the rule enforceable rather than merely stated.

The Chair verifies against the recorded method. A request to change a method is a Committee decision requiring a vote, minuted as such. No such request has been made in this program.

2. What a Condition Is, and What It Is Not

Three things get confused with conditions, and each has a different owner and a different consequence.

	Raised by	Owned by	Consequence of not closing
Gate condition	The Committee, at a gate	A named individual	A gate matter at the following gate. Blocks nothing immediately, but the Committee must address it before deciding again.
Action item	Any forum	Whoever accepted it	Chased operationally. No governance consequence.
Risk	Anyone, any time	A named owner in the RAID log	Monitored. May never materialize.
Must-meet criterion	Fixed when the gate was defined	The program	Blocks the gate outright. Cannot be converted into a condition.

One distinction above carries more weight than the rest. A condition attaches to a gate that carried. It is the mechanism for a Committee to say “this is good enough to proceed, and this specific thing must still be true by a specific date.”

It is not a mechanism for passing a gate that should have failed. A must-meet criterion that is unsatisfied produces RECYCLE, not a condition — and a Committee that converts an unmet must-meet into a condition has quietly removed the distinction between passing and not. That is the most common way condition mechanics get abused, and the Gate Decision Framework forecloses it by assessing must-meets before scoring begins.

2. Register

Ref	Condition	Owner	Issued	Due	Closed	Status
GC-01	Complete analytical method re-qualification at Aldergate for all three methods	Dr. K. Oyelaran	30 Jun 2026	18 Dec 2026	—	open
GC-02	Confirm the cardiovascular sub-study protocol with the DMC before first CV-cohort dosing	Dr. S. Aldridge	30 Jun 2026	30 Nov 2026	25 Sep 2026	closed
GC-03	Stand up the payer evidence plan and hold the first advisory boards	J. Barrington	30 Jun 2026	31 Mar 2027	—	at-risk

1 closed, 2 open, 1 at risk. All three were issued at the same gate, which is normal — conditions attach to an outcome, and a single GO WITH CONDITIONS decision produces the whole set.

Two of the three arise from should-meet criteria scored at threshold, which is the mechanism described in the Gate Decision Framework: a score of 3 means “satisfiable inside the next stage”, and every threshold score must produce a condition. The third, GC-02, arose from a scope change rather than a score — conditions may be issued for other reasons, but a threshold score must always produce one.

3. Condition Records

GC-01 — Complete analytical method re-qualification at Aldergate for all three methods

Field	Record
Issued	30 June 2026 at Gate 4
Arises from	S1 — CMC readiness (scored 3)
Owner	Dr. K. Oyelaran
Due	18 December 2026
Addresses	I-02; the CMC readiness score recorded at Gate 4
Status	open

Why it was issued

Two of three methods had re-qualified at the gate. The third had failed first-pass acceptance and was in remediation. A Phase 3 authorization depends on the ability to release registration batches, which depends on qualified methods.

Verification method — fixed at issue

Signed method qualification reports for all three analytical methods, issued by Aldergate quality and countersigned by Vitalis QA. Reports must demonstrate accuracy, precision and specificity against the acceptance criteria in the transfer protocol as written at transfer, not as amended during it.

Progress

Date	Progress
15 Jul 2026	CMC team embedded on site at Aldergate.
28 Aug 2026	Method 2 re-qualification report signed.
30 Sep 2026	Method 3 re-run against protocol acceptance criteria; results within specification, report in preparation.

Open, on-track. Due 18 December 2026.

GC-02 — Confirm the cardiovascular sub-study protocol with the DMC before first CV-cohort dosing

Field	Record
Issued	30 June 2026 at Gate 4
Arises from	CR-02 scope addition
Owner	Dr. S. Aldridge
Due	30 November 2026
Addresses	CR-02 scope addition
Status	closed

Why it was issued

The sub-study was added after the Phase 3 protocol was finalized. A protocol amendment that changes what is monitored cannot proceed to dosing without the monitoring body having seen it.

Verification method — fixed at issue

Written confirmation from the Data Monitoring Committee chair that the cardiovascular sub-study protocol and its safety monitoring plan have been reviewed and accepted, dated before first CV-cohort dosing.

Progress

Date	Progress
12 Aug 2026	Sub-study protocol issued to the DMC.
25 Sep 2026	DMC chair confirmation received. Condition closed.

Closure

Closed 25 September 2026, 66 days ahead of the due date. Verified by the Chair against the method recorded at issue.

GC-03 — Stand up the payer evidence plan and hold the first advisory boards

Field	Record
Issued	30 June 2026 at Gate 4
Arises from	S2 — market access evidence (scored 3)
Owner	J. Barrington
Due	31 March 2027
Addresses	R-06; the market access score recorded at Gate 4
Status	at-risk

Why it was issued

The commercial case depends materially on payer coverage (R-06, A-06). At the gate an evidence plan existed in draft and no advisory board had been convened, three years into the program.

Verification method — fixed at issue

Evidence plan approved by the Development Committee, and minutes from at least three of five target payer advisory boards demonstrating the boards were HELD. Scheduling is not closure.

Progress

Date	Progress
30 Jul 2026	Evidence plan approved by the Committee.
18 Sep 2026	Two advisory boards held; minutes filed.
09 Oct 2026	Two of five remaining boards still unscheduled against the due date. Escalated to the Committee; owner asked to present a recovery plan at the November checkpoint.

At risk. Two of five target payer advisory boards remain unscheduled

The verification method requires the boards to have been held. Two of five remain unscheduled against a 31 March 2027 due date, and an advisory board cannot be convened at short notice. The Chair has no authority to accept scheduling in place of attendance — changing the standard would require a Committee vote, minuted as such.

5. What Makes a Verification Method Adequate

Since the verification method cannot be changed after issue, writing a weak one is a decision the Committee lives with. Three properties separate a method that works from one that does not.

Property	Adequate	Inadequate
Observable	“Minutes from at least three advisory boards demonstrating the boards were held”	“Payer engagement underway” — unobservable, and true of almost any state
Binary	“Signed qualification reports for all three methods”	“Substantial progress on method transfer” — who decides what is substantial?
Owned by evidence, not opinion	“Written confirmation from the DMC chair, dated before first dosing”	“The team is satisfied the protocol is acceptable”

Read GC-03's verification method against the second row. It requires the advisory boards to have been held, with minutes. It does not say “scheduled”, and it does not say “planned”.

That wording is now load-bearing. Four months on, the boards are partly unscheduled, and the condition cannot be closed on a scheduling commitment however reasonable the argument. Had it been written as “a payer engagement plan in place”, it would have closed in July and the gap would have reached the market unrecorded — which, per the Post-Launch Review, is roughly what happened anyway. The condition did not prevent the outcome. It did ensure nobody could later claim it was unforeseen.

4. What the Register Shows

Three conditions is a small sample, but the pattern in it is worth naming.

GC-02 closed early and easily. It required a confirmation from a body that had every reason to give one, on a protocol that had already been written. Conditions of this type — where the work is a procedural step rather than a substantive gap — close on time and tell you very little.

GC-01 is closing on schedule but only because the program spent money on it. The condition addressed a real technical gap, and closing it required an embedded team on site and a $1,850,000 contingency draw. It will close, and the cost of closing it is visible.

GC-03 is behind, and it is behind for the same reason it was issued. The criterion scored 3 at Gate 4 because market access work had been scoped but not started. Four months later the work is still partly unstarted. A condition issued against a gap that exists because the work was deprioritized does not close by itself — the priority has to change, and nothing in the condition mechanism forces that.

The limit of the mechanism. A condition converts a weak position into a dated, owned, verifiable obligation. It does not create the capacity to meet it. Where a threshold score reflects a resourcing choice rather than a technical gap, the condition will tend to run late unless the underlying choice is revisited — which is a Committee matter, not a condition matter, and is why GC-03 has been escalated rather than simply chased.

7. When a Condition Cannot Be Closed

The register has no entry for this yet, but the mechanics exist and are worth stating before they are needed.

Situation	Route
The work is complete but the evidence differs from the recorded method	Committee decision, minuted. The Chair cannot accept substitute evidence.
The date will be missed but the work will complete	Owner presents a recovery plan at the next checkpoint. The due date is not silently moved.
The condition has become impossible or irrelevant	Committee may retire it, recording why. A retired condition stays in the register.
The condition will not close before the next gate	It becomes an input to that gate's assessment. An open condition does not automatically block a gate, but it is on the table.

Nothing here permits quiet closure. Every route ends in a Committee decision that is recorded, and a retired condition remains visible in the register with its reason attached. The register is a permanent record, not a work list — items leave it by being resolved, never by being deleted.