Program Charter

Vitalis Therapeutics Inc. — This charter formally establishes the VitaFlow (VTX-401) development program: its business case, scope, governance, funding ceiling and roster. It is chartered at the Gate 4 Phase 3 authorization of 30 June 2026 and speaks as at 15 October 2026. Detailed figures live in their owning documents and are cross-referenced rather than restated.

1. Charter Authorization & Purpose

This charter establishes the VitaFlow (VTX-401) development program at Vitalis Therapeutics Inc.. It is chartered at the 30 June 2026 Gate 4 decision — the authorization to initiate Phase 3 and the release of the $125,800,000 Stage 4 tranche, the largest single authorization in the program and the last before the New Drug Application.

Gate 4 is the correct anchor for a charter rather than Gate 0 or Gate 1, because a development program is not meaningfully chartered while the molecule may still fail for reasons no amount of program management can address. Before Phase 2 read-out, what exists is a funded option. At Gate 4 the option was exercised: the dose is selected, the pivotal design is agreed with the agency, and the organization has committed the capital that makes a filing possible. This document records what was authorized at that moment and under what conditions.

2. Business Case & Strategic Context

Chronic weight management is a therapeutic area where the standard of care moved decisively within a single product cycle, and where the constraint on uptake is now less clinical efficacy than tolerability, supply and payer coverage. VitaFlow is positioned against that constraint: the program's differentiation thesis is tolerability at an efficacious dose, not a larger magnitude of weight reduction.

3. Program Vision & Product Description

The program develops, files and launches VitaFlow (VTX-401): a long-acting GLP-1 receptor agonist administered as a once-weekly subcutaneous injection from a single-use prefilled pen, indicated for chronic weight management in adults with a body mass index of 30 or above, or 27 or above with at least one weight-related comorbidity.

The molecule is a new molecular entity. It is filed under 505(b)(1) New Drug Application — new molecular entity — Decision D-01 — because no listed drug is suitable to reference; a 505(b)(2) route was assessed at Gate 1 and closed. That single decision determines the shape of the entire development program: a full nonclinical package, a complete clinical program from first-in-human, and a self-contained CMC dossier, with nothing carried across from an originator's file.

Formulation scope is deliberately narrow. An oral formulation is out of scope at launch (Decision D-02): the bioavailability work would add an estimated eighteen months and a second CMC program for a segment the launch case does not require. Geographic scope is similarly narrow — United States first, with a European filing deferred to Year 4 or beyond (Decision D-03), avoiding parallel scientific advice and a second dossier during the Phase 3 window.

Class labeling for thyroid C-cell tumors will be carried consistent with approved products in the class, and no Risk Evaluation and Mitigation Strategy is proposed at filing (Decision D-07). The safety database does not support a REMS, and volunteering one would impose a commercial disadvantage the evidence does not require.

4. Objectives & Success Criteria

1. Meet the co-primary endpoints agreed at the End-of-Phase-2 meeting across both pivotal trials — percent change in body weight and the proportion of participants achieving at least a five percent reduction.
2. Demonstrate the tolerability thesis. Discontinuation attributable to gastrointestinal adverse events is a monitored endpoint, not a footnote; the differentiation claim stands or falls on it.
3. Submit the NDA by 30 September 2028 with registration batches manufactured, on stability, and process validation complete — a filing date is a manufacturing date as much as a clinical one.
4. Secure approval at the 11 October 2029 action date under a standard review clock, with no assumption of priority review or breakthrough designation (Assumption A-02).
5. Clear the 15.0% hurdle on the business case as re-tested at each remaining gate on refreshed assumptions, not on the Gate 4 set.
6. Close every Gate 4 condition against the evidence standard recorded when it was issued, rather than one renegotiated at closure.
7. Reach first commercial shipment on 01 November 2029 with launch supply, payer evidence and field readiness demonstrated at Gate 6 rather than asserted.

5. Program Scope

In scope

• Completion of the Phase 3 program — two pivotal trials and the cardiovascular outcomes sub-study added under CR-02.
• Pharmacovigilance and safety reporting across the development program, including expedited reporting obligations that sit outside program governance (C-04).
• CMC scale-up, registration-batch manufacture, process validation and ICH stability at Aldergate Biologics.
• NDA assembly, submission and review support, including responses to information requests through the review cycle.
• Market access evidence generation, payer advisory boards and launch pricing strategy.
• Launch readiness across supply, distribution, field medical and commercial operations.

Explicitly out of scope

• Oral formulation development (Decision D-02) — deferred, not abandoned.
• European and Asia-Pacific marketing applications (Decision D-03) — the Phase 2 Asian cohort added under CR-01 supports a later filing but does not constitute one.
• Additional indications — cardiovascular risk reduction, sleep apnoea and adolescent populations are lifecycle candidates and carry no budget or resource in this program.
• Internal trial operations capability (Decision D-04) — Phase 3 execution is contracted to Meridian Clinical Research.
• A Risk Evaluation and Mitigation Strategy at filing (Decision D-07).
• Post-approval commitments not yet negotiated with the agency — these are scoped after the action date, not before it.

6. Stage-Gate Structure & Gate Calendar

Seven gates, each releasing the funding for the stage that follows it and no further. The gate structure maps deliberately onto the regulatory pathway rather than onto a generic project lifecycle — the agency's decision points are the program's decision points, because they are where genuinely new information arrives.

Full gate mechanics, the must-meet and should-meet criteria and the scored record live in the Gate Decision Framework. Gate 2 is a submission gate rather than a funding gate: the IND is filed within the Stage 2 tranche, and the thirty-day safety review is a regulatory clock, not a governance one.

7. Key Deliverables & Milestones

8. Governance & Decision Rights

A seven-seat Development Committee holds five votes and decides every gate outcome. The Chair facilitates, certifies evidence quality, and does not vote — the person accountable for the program's progress is not the person who decides whether it continues (Decision D-09).

Mandate, quorum, conflict-of-interest handling and the defined gate outcomes are set out in the Development Committee Charter, the governing instrument this charter operates under.

9. Chair Authority & Limitations

The Chair sets the gate agenda, certifies that tabled evidence meets the standard recorded when a condition was issued, verifies and closes Gate Conditions against their recorded verification method, and maintains the readiness assessment and conditions register between gates.

The Chair does not: vote on a gate outcome; close a condition the Chair personally owns; renegotiate a verification method after issue; authorize spend beyond the tranche a gate has released; or overrule a Data Monitoring Committee recommendation. Each of these requires a Committee decision, minuted.

10. Organization & Roster

Life-of-program headcount is 109 people, ramping by stage and totalling 191,420 hours. That divides into 102 people across 10 working functions, which carry deliverables and appear in the work breakdown structure, and the 7-seat Development Committee, which is oversight only, carries no work-breakdown assignment, and holds no deliverable — which is precisely the condition that lets it decide. Every figure below is the same roster seen from a different side: the table here is the organizational cut, and §5 of the Program Budget is the same rows costed at a blended rate.

Functional leadership

Contracted partners

Cost detail by function, and the reconciliation tying every allocation to these envelopes, live in the Program Budget and the Resource Plan.

11. Stakeholders

12. Budget Authorization

The authorized ceiling is $243,040,000: a base program of $217,000,000 plus a 12% contingency reserve of $26,040,000. The ceiling is a ceiling, not an appropriation — see §13.

Phase 3 alone is $109,100,000, 50% of the base program. That concentration is the reason Gate 4 carries the weight it does: nearly half the program's cost sits behind a single authorization.

13. Funding Release Mechanism

No stage is funded before the gate preceding it carries. Each tranche is released on the gate decision and is spendable only against that stage's scope.

14. Contingency & Financial Controls

The $26,040,000 reserve is held at program level and released by the Committee against a named risk or an approved change. It is not a stage-level buffer and functional leads cannot draw on it.

Draws to the status date

Spend to the status date

The largest draw, $7,200,000, funds the cardiovascular sub-study approved under CR-02. It is recorded as a change with a contingency draw rather than as a Phase 3 overrun, because the scope was added deliberately and the distinction matters to anyone reading variance later.

15. Regulatory & Compliance Framework

The program files a 505(b)(1) New Drug Application — new molecular entity with the Center for Drug Evaluation and Research. Standard review, 10-month PDUFA goal from filing acceptance (A-02).

Agency interactions

The End-of-Phase-2 meeting on 19 May 2026 is the single most consequential interaction in the program: it fixed the pivotal design, the co-primary endpoints and the cardiovascular safety expectation that produced CR-02. Gate 4 was scheduled deliberately after it, so that the Phase 3 authorization was taken with the agency's position known rather than assumed.

Compliance obligations

16. Risk Assessment

The full log with owners, scoring and movement between gates lives in the RAID Log. Two risks are rated High and both are clinical: this is a program whose principal uncertainty is the molecule, not its execution — which is the normal and correct risk profile for an asset in Phase 3.

Live Gate 4 conditions

17. Assumptions

A-02 and A-03 deserve particular attention: the plan assumes neither an expedited review nor an advisory committee. Both assumptions are conservative in the direction that matters — an expedited review would pull revenue forward, while an advisory committee would add cost and time the budget does not carry. The asymmetry is deliberate.

18. Constraints

19. Dependencies

Every dependency listed is a hard sequence, not a preference. DEP-03 and DEP-04 in particular are the ones that most often move a filing date, because manufacturing readiness is frequently planned as though it runs in parallel with clinical read-out when in practice it gates on it.

20. The Boundary of the Authorization

A stage-gate charter is defined as much by what it withholds as by what it grants. This charter does not authorize:

• Spend beyond the Stage 4 tranche. Stage 5 funding is released at Gate 5 or not at all.
• A full-program earned value baseline. Stage 5 scope is not baselined at the level EVM requires, and publishing indices computed on an unbaselined stage would be a fabricated precision.
• Any lifecycle indication. Additional indications require their own business case and their own Gate 0.
• Post-approval commitments. These are negotiated with the agency during review, not pre-authorized here.
• Deviation from GxP under any schedule or cost pressure (§15).
• Continuation through a Data Monitoring Committee stop recommendation (§8).

21. Authorization & Sign-off

Authorized at the Gate 4 decision of 30 June 2026, recorded outcome GO WITH CONDITIONS (5-0-1), with the conditions at §16 attached.