PharmAla's ALA-002 Phase 2 Trial Cost and Funding Analysis

Source:https://chatgpt.com/share/68df1da4-3cd4-8001-838d-8b381d042134

Excellent question — and this one gets to the realistic funding milestone PharmAla needs before fully entering Phase 2 with ALA-002 in Australia.Let’s break it down with both biotech-specific cost structure and Australian R&D advantages:

🇦🇺 Estimated Cost to Initiate ALA-002 Phase 2 Trial in Australia

1️⃣ Pre-Trial Preparation Costs

These are up-front expenses needed before first patient dosing, including:

ItemTypical Cost (CAD)
Protocol design, ethics & TGA approvals0.5–0.5 – n1.0 M
CMC (manufacturing / stability / formulation validation)1.5–1.5 – n2.5 M
Pre-clinical bridging & safety data prep0.3–0.3 – n0.7 M
CRO selection, site startup, investigator training0.5–0.5 – n1.0 M
Drug import, logistics, regulatory filings0.3–0.3 – n0.6 M
Subtotal (pre-initiation)≈ 3–3 – n5 M CAD

2️⃣ Early Trial Execution (first 6–12 months)

Once approval is received and the trial begins enrolling patients:

ItemTypical Cost (CAD)
Initial patient recruitment (30–50 patients)2–2 – n4 M
Site management, data monitoring, safety reporting1–1 – n2 M
Analytical / lab work, clinical supplies0.5–0.5 – n1.0 M
Subtotal (first-phase execution)≈ 3.5–3.5 – n7 M CAD

🔹 Total Needed to Initiate Phase 2 in Australia:

≈ CAD $6 – 12 million (depending on scale and number of sites)This range gets PharmAla to the “first patient dosed” milestone and funds the initial patient cohort through early data readout — often what investors call the Phase 2a start.

🇦🇺 After R&D Rebate

Because of the 43.5 % Australian R&D refund, PharmAla could expect roughly 2.6–2.6 – n5.2 million back after the first year, effectively lowering net outlay to:👉 Net effective cost: ≈ CAD $3.5 – 7 million

Summary

StageGross Cost (CAD)R&D Rebate (43.5%)Net Cost
Trial initiation (Phase 2a start)$6–12 M$n2.6–5.2 M$3.5–7 M

💡 Interpretation:
PharmAla likely needs **~6–10Mupfrontcash∗∗toconfidentlystartALA−002’sAustralianPhase2trial.Theremainderoftheir6–10 M upfront cash** to confidently start ALA-002’s Australian Phase 2 trial. The remainder of their n30 M ATM can cover full trial completion, manufacturing scale-up, and subsequent data analysis.Would you like me to show a cash-flow projection (month-by-month over 24 months) for how that $30 M might be allocated between setup, patient dosing, and rebate returns?