For General Information, page-484

I take your point about some up front set-up costs, but doubt the deduction that the placement/EO split has anything to do with chronology as both sets of funds were due to be in before trial commencement. The split up given for “Use of Funds Raised” seems to be more aligned to prioritisation given there was more risk on raising the EO funds (which has borne out). This aligns with all the “Ongoing progression of other trials” and “Working Capital” all being accounted for in the placement funds raised when these costs are spread out over the two or so years until futility.

Sofpromed, a full service CRO, has a good article on their website (look under “Articles” and older articles until you find “How Much Does it Cost to Manufacture a Drug for a Clinical Trial” or just google it). The article was written Dec 2020. In it they say there is variance in costs depending on the drug, but give a ball park estimate breakdown. This is broken into (all figures US dollars):

1. Project planning and management - $35k
2. Supplier Management - $4k
3. Drug Product Analytical Development - $40k
4. Batch Manufacturing (they assume 3000 vials of an injectable drug, but ANP will need approximately 4000 vials (76 x 52 x $40 per vial = $160k). Adding filter validation ($35k), creation of batch records ($20k), stability studies ($55k) brings the total for batch manufacturing to $270k

Total Project Cost Estimate = $349,000 or in AUD - $492k - let’s round to $500k

ATL1102 Ionis patents on drug creation have expired in 2019 (if they hadn’t, they would appear on the ANP annual report patent list - they disappeared post 2019). So unless there is something on the licence agreement with Ionis, let’s assume no royalty payment out of patent protection.

$500k is a lot less than $14.8 mill or $7.4 mill at the very least (if they have plunked all manufacturing costs into this raise, which then makes the option exercise at futility of the same $amount hard to explain).