CF 33 General Discussion

In the spirit of concentrating comments on specific therapies and their various sub headings here is a new thread called CF 33 General Discussion.

To summarise some recent comments;

1. In the Independent Experts Report accompanying the recommendation to shareholders Aug 2019 in relation to the acquisition of the CF33 rights from COH the valuer is quoted as saying at that time,“The analysis supports an after-tax valuation of $124.5 million for the current Imugene portfolio in the range $99.6 million to $149.4 million and $22.2 million with a range of $18.9 million to $25.6 million for the CF33 rights. In both cases, the valuations assume a scenario in which Imugene develops the various units IP to completion of Phase 2 human studies and then licenses to a large, globally operating pharmaceutical or biotechnology company.”So that value was in 2019. Wonder where it sits now and what might be achieved.?

2. The terms of the Share Sale AGT tween IMU and PH company Vaxinia provided for milestones as well as an initial up front. So part b below may have been missed but that doesn’t affect rest of deal. Just to clarify.”

From Independent Expert Report - Maximum number of Shares to be issued Up to 107,031,451 Consideration SharesExpected date of issueThe Consideration Shares will be issued as follows:

(a) 22,039,290 Consideration Shares will be issued upon completion of the Share Sale Agreement and by no later than 3 months from the date of approval being granted under this resolution 1;
(b) 25,183,871 Consideration Shares will be issued upon allowance of investigational new drug (IND) application by the US Food and Drug Administration (FDA) in respect of CF33 and by no later than 30 June 2021;
(c) 28,328,452 Consideration Shares will be issued upon dosing of first patient in a Phase 1 Clinical Trial for CF33 and by no later than 31 March 2022; and
(d) 31,479,839 Consideration Shares will be issued upon Imugene meeting Phase 1 safety endpoints excluding efficacy and dose of CF33 and by no later than 30 June 2024.
So now we debate what an allowance of an application means - is it that the application has been lodged or is it a formal FDA term?

3. “(b) 25,183,871 Consideration Shares will be issued upon allowance of investigational new drug (IND) application by the US Food and Drug Administration (FDA) in respect of CF33 and by no later than 30 June 2021. The thing I have with the wording is that it requires a positive action called “an allowance” by the FDA. If they had intended that it be triggered by the simple lodgement of an application the wording would have said either lodgement or submission. I am looking into the FDA terminology to try to determine what an allowance means as it’s an odd phrase for me.Terms are not specifically defined from initial analysis but when reviewing the use of the terms Allowance is more like a permission to proceed to a next step in a Trial. But it isn’t an approval as that level of analysis hasn’t yet been done by the FDA. Also Approval seems to be used in the context of Approval for use. So their contexts seem different.