Ann: IND clearance received from US FDA for CHM 1101, page-16

They are basing that simply on how the FDA has moved ahead with the five already approved CAR-T therapies for lymphoblastic leukemia, large B-cell lymphoma and multiple myeloma.. all blood based cancers.

This was all uncharted waters until August 2017 when the first CAR-T therapy known as Kymriah (from Novartis) was approved ... which as some may know was a licensed product from University of Penn, which is where the newly licensed CDH17 product we licensed was from.

Kite Pharma were next off the rank in October 2017 with Yescarta, and Gilead bought them for US$11.9bn in August 2017 leading up to approval.

Jul 20 came Tecartus again from Kite Pharma/Gilead, then followed by Breyanzi in Feb21 who was from Juno Therapeutics who was purchased by Celegene in Jan18 for US$9bn. Bristol Myers Squibb acquired Celgene in Nov19 for $US95n.

The latest approval came in Mar21 for Abecma which is also a Celgene / Bristol Myers Squibb.

So the above approvals provide guidance on what sponsors need to demonstrate before the FDA will approve their product. Things like how many patients need to be enrolled into the trial (they ranged from 63 to 268, with an average of approx. 130. Also the type of outcomes they'd deem approvable e.g. overall response were around 73-87% and complete response from 54%-62% in the above products. Also on safety outcomes, where all had severe side-effects such as cytokine release syndrome and Neurologic toxicities - both very serious and can lead to death. But because there is no alternative, the FDA will allow these side-effects if they are not excessively high.

The above outcomes are exceptional if you consider that these blood based cancers were previously a death sentence... now sufferers of the above mentioned blood based cancers have hope.

This explains why the FDA was able to accelerate the approval of CAR-T therapies, and is more than likely going to do the same for solid cancers as they remain a bar too high for CAR T therapies to date.

This is where the two assets we have in CLTX and CDH17 (third-gen CAR T) are looking to clear that bar. And if you look at the pre-clinical data, there is very good reason to be excited about what these two assets can achieve in the clinic. And it all starts with the phase 1 trial data, and we'll get an early snap shot of that in the coming months.

Needless to say it is early days, but the upside from a humanity perspective as well as a financial one for shareholders is staggering.

As a simple example, if CHM was to follow a similar path to Juno and Kite (with an approx acquisition price of US$10bn), then if you invested A$10,000 (approx 30,000 shares) into CHM today.. at US$10bn with an exchange rate of AUD/USD 0.72, the acquiring entity would buy your 30,000 shares for A$1.39m (assuming there is no further dilution).