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Speaker 1: Welcome to Fear and Greed Sunday feature. Oh, Michael Thompson,

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Speaker 1: Now you're going to have to indulge me a little

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Speaker 1: bit on this one because we have aired this interview before,

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Speaker 1: but it's getting another run today for very good reason

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Speaker 1: because the share price a biotechnology company, miso Blast, this

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Speaker 1: week shot up by fifty percent in just one day

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Speaker 1: after the US Food and Drug Administration gave the green

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Speaker 1: light to a cell therapy treatment that miso Blast had developed.

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Speaker 1: The treatment will be used for children with a life

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Speaker 1: threatening complication that can occur during bone marrow transplants. Now

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Speaker 1: that one comes after the FDA recognized another treatment back

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Speaker 1: in January, this time for heart disease in newborn babies.

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Speaker 1: It means that the share price of miso Blast is

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Speaker 1: now up nearly nine hundred percent over the last year.

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Speaker 1: Now back in March of twenty twenty two, so we're

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Speaker 1: going back two and a half years now. Sean Aylmer

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Speaker 1: spoke to Sylvie Etescu, who is the founder and CEO

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Speaker 1: of miso Blast, about the many hurdles, many many hurdles

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Speaker 1: that a biotech company like Mesoblast has to clear in

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Speaker 1: order to bring a product to market. It is a

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Speaker 1: fascinating chat and a great insight into the way a

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Speaker 1: company like this operates. I hope you enjoy it.

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Speaker 2: Welcome to the Fear and Greed Daily Interview. I'm Sean Almer.

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Speaker 2: Regular listeners would have heard me mention Misoblast many times before.

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Speaker 2: The ASX listed biotech company has a very volatile share price,

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Speaker 2: largely because it's tied to medical research, the approval processes

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Speaker 2: of the US Food and Drug Administration, and deals with

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Speaker 2: other pharmaceutical companies. But it's a fascinating company doing innovative

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Speaker 2: research into stem cells and trying to navigate the very challenging,

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Speaker 2: very expensive process of bringing those products to market. Silvio

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Speaker 2: with Tescu is the founder and CEO of Misoblast, Sylvia.

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Speaker 2: Welcome to Fear and Greed.

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Speaker 3: Thanks for having me so.

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Speaker 2: Firstly, can you give our listeners a one oh one

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Speaker 2: on Mesoblast the products you're developing, where they're up to

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Speaker 2: in plain English, of course, which is the tricken sometimes

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Speaker 2: in the biotech sphere.

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Speaker 3: Certainly, we're developing products using a platform technology that allows

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Speaker 3: us to develop off the shelf therapeutics viials that contain cells.

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Speaker 3: We understand how these cells are made, they're highly scalable

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Speaker 3: into large quantities, and we have a supply chain that

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Speaker 3: from manufacturing we can ship and provide them to hospitals

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Speaker 3: to physicians in a regulated manner. We understand how these

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Speaker 3: cells work. They target severe inflammatory conditions, and we've been

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Speaker 3: able to generate large clinical data sets as we progress

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Speaker 3: towards our first product approvals, particularly in the US, which

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Speaker 3: is the largest market and the largest unmet need. But

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Speaker 3: we already have a first product approved then being sold

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Speaker 3: in Japan. So this is the beginning of a whole

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Speaker 3: new industry. It's been a long time coming, but we're

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Speaker 3: very confident that we're going to have more products available

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Speaker 3: using out proprietary scalable technology. We're the largest and most

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Speaker 3: advanced cell therapy company in the world, and I think

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Speaker 3: it's going to be an exciting the next couple of years.

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Speaker 2: Okay, So the competitive advantage of mesoblast is that scalability

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Speaker 2: and process is that right.

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Speaker 3: There are multiple advantages, but certainly scalability and being able

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Speaker 3: to create a uniform process that ensures that each product

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Speaker 3: meets the exact same requirements as the next product, so

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Speaker 3: that we can provide with certainty outcomes to patients. That's

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Speaker 3: a major advantage. But secondly, we have over one thousand

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Speaker 3: patents and the other big commercial advantages that we have

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Speaker 3: very strong patent position intellectual property profile that creates a

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Speaker 3: barrier to entry into this space. And the combination of

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Speaker 3: patents plus a scalable technology is a very powerful combination,

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Speaker 3: together with many years of Phase three clinical trials that

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Speaker 3: demonstrateed the clinical value and the success of the technology.

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Speaker 2: Okay, so some of the illnesses that you are addressing,

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Speaker 2: what are they? How would most of us know them?

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Speaker 3: Yeah? So I've said that core to the mechanism of

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Speaker 3: the cells is the ability to tackle severe inflammation. So

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Speaker 3: we are targeting diseases where inflammation is a primary driver

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Speaker 3: of a bad outcome, including death, and where other traditional

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Speaker 3: medicines pills, antibodies don't work very well. So a first

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Speaker 3: disease is a very severe inflammatory condition called graph versus

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Speaker 3: host disease caused by a bone mirror transplant in patients

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Speaker 3: who are otherwise cured of the underlying leukemia with drugs,

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Speaker 3: but need to have their bone mirror rebuilt. And when

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Speaker 3: you use another person's bone marrow to rebuild your own,

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Speaker 3: it often thinks your foreign it attacks your body and

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Speaker 3: creates this g versus host disease that has up to

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Speaker 3: a ninety percent fatality rate within a couple of months.

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Speaker 3: So other drugs have failed miserably, and we're particularly in

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Speaker 3: children where there is nothing approved. We have shown through

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Speaker 3: multiple studies that we get a very substantial curative rate

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Speaker 3: and survival benefit in children who have up to ninety

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Speaker 3: percent mortality from this devastating condition, and so we completed

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Speaker 3: a FACE three program. We presented the data to the

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Speaker 3: FDA about a year ago. The experts who were asked

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Speaker 3: by the FDA to appine on the results voted nine

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Speaker 3: to one that the results were sufficient for approval, and

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Speaker 3: the FDA delayed us at that point and has asked

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Speaker 3: us to just improve certain aspects of the manufacturing process

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Speaker 3: called potency essays, that we've now put in place, and

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Speaker 3: we expect to be going back to the FDA shortly

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Speaker 3: to present the new data which we think will be

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Speaker 3: sufficient to support moving forward towards approval. That same product,

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Speaker 3: as I said earlier, has already been approved and is

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Speaker 3: being sold in Japan for the last four years. Very safe,

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Speaker 3: very effective, and I think that provides a strong impetus

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Speaker 3: to how this product and insight as to how this

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Speaker 3: product would be received in the US market and hopefully

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Speaker 3: would be available to children with this devastating complication. Beyond

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Speaker 3: grab mississost disease, we're also targeting inflammatory conditions that affect

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Speaker 3: back pain, for example, that destroys the intravertebral disc and

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Speaker 3: causes severe pain and suffering in large numbers of patients.

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Speaker 3: In fact, inflammatory back pain is the number one cause

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Speaker 3: of opioid prescriptions, accounts for fifty percent of prescriptions in

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Speaker 3: the US market and likely to be a major cause

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Speaker 3: of opioid usage in Australia as well. And a single

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Speaker 3: injection of ourselves in phase three trials has demonstrated very

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Speaker 3: substantial reduction in pain for twelve months, twenty four months,

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Speaker 3: and even up to thirty six months without any adverse events.

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Speaker 3: So we again spoken extensively with the US FDA, who

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Speaker 3: reviewed our data and agreed with us about how a

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Speaker 3: second study, if confirmatory of the first, would likely lead

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Speaker 3: to FDA approval, and we're embarking on that program to

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Speaker 3: target against those patients with severe inflammation of the disc

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Speaker 3: who failed all existing alternative therapies. In order to prevent

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Speaker 3: the need to progress towards something much more invasive like surgery,

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Speaker 3: or to avoid the opioid overdose risks that come along

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Speaker 3: with this kind of devastating problem.

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Speaker 2: Okay, I'm going to get confused here. Is that rema

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Speaker 2: stem cell, remy stem cell.

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Speaker 3: Is our lead product for graph as host disease and

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Speaker 3: also for inflammatory bowel disease that involves the colon ulstript

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Speaker 3: colliders and crows disease. The product for the back is

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Speaker 3: called rex lemistro cell, So that's our second lead product,

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Speaker 3: and that's being developed for both back and for heart disease.

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Speaker 3: But you are quite correct that remy stem cell, the

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Speaker 3: lead product that were devoloping for GVHD, also is being

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Speaker 3: developed for a second indication, which is inflammation of the

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Speaker 3: colon from in ulcer of colidis and Crohn's disease. And

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Speaker 3: we just announced some pretty exciting data about a week ago,

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Speaker 3: data that was generated in a study at Cleveland Clinic

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Speaker 3: by one of the world's leading gastroentrology surgeons in this field,

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Speaker 3: Dr Amy Laitner, presented data at the major European Congress

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Speaker 3: showing that a single injection of remy stem cell into

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Speaker 3: the inflamed colon in patients with ulcer of colitis or

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Speaker 3: Croh's disease resulted within six weeks in remission, which is

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Speaker 3: a very very exciting finding.

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Speaker 2: I have family members who have had Crane's disease and

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Speaker 2: it's not a good thing.

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Speaker 3: It's a terrible disease, and particularly in those patients who

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Speaker 3: have not responded to other anti inflammatory drugs out there,

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Speaker 3: including the monoclonal antibodies against TNF. For those patients if

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Speaker 3: they have continued inflammation of the large bowl on the

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Speaker 3: alternatives collected me which is a terrible outcome. And so

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Speaker 3: we are very very focused on this as a potential

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Speaker 3: next indication for remy stem cell and we'll be updating

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Speaker 3: the market in short order with more data from that study,

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Speaker 3: and we expect to be then moving to have discussions

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Speaker 3: with the FDA around further approval potentially after GVHD in

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Speaker 3: the area for remy stem cell in the area of

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Speaker 3: inflammatory bowel disease.

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Speaker 2: Stay with me, Sylvia will be back in a minute.

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Speaker 2: My guest this morning is Sylvie Etescu, founder and CEO

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Speaker 2: of Miso Blast. Okay, talking to you. It's exciting thinking

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Speaker 2: about what you can do and hopefully you know this

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Speaker 2: can be proven the process of actually bringing to market

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Speaker 2: the phase one, two, three, four trials in the US,

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Speaker 2: I mean, how long does that take? How expensive is it?

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Speaker 2: I'm trying to get my head around that sort of information.

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Speaker 3: Well, look, this is a great question, and I think

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Speaker 3: it's important for investors in the biotech space to have

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Speaker 3: a reality check and a view on the time and

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Speaker 3: the cost of drug development. Traditionally, small molecules developed by

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Speaker 3: the pharmaceutical industry cost up to two billion dollars two

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Speaker 3: billion per successful new drug launched, so it's very expensive

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Speaker 3: and very few companies that's successful in doing it. I

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Speaker 3: think we've raised a substantial amount of capital and we

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Speaker 3: now have the potential to bring four new indications to

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Speaker 3: the marketplace, which is a We think that we've done

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Speaker 3: it in a relatively efficient way. But time is something

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Speaker 3: that is you can't get around. Time is the requirement

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Speaker 3: by the regulatory bodies like the FDA or like the

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Speaker 3: TG in Australia to require you to do large phase

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Speaker 3: three trials and they just take two, three, four years

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Speaker 3: sometimes depending on the indications and the size, and there's

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Speaker 3: no substitute for there's no short circuits, and I think

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Speaker 3: people need to understand that things look promising early on,

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Speaker 3: but then there's often a fair amount of time that

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Speaker 3: goes by when you don't hear anything until the trials finish.

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Speaker 3: And the strength of mesa Blast is that we have

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Speaker 3: a platform technology and we're not a one trick pony,

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Speaker 3: and therefore we have four programs in phase three. With GVHD,

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Speaker 3: we've completed Phase three and that means that for investors

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Speaker 3: who are knowledgeable and understand the risks around single product companies,

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Speaker 3: we represent the ability to move into commercial sphere with

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Speaker 3: multiple products, with potentially multiple revenue streams, and that's how

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Speaker 3: we're building mesa Blast and we hope to be there

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Speaker 3: in the very short term in terms of revenues from

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Speaker 3: our first approved product in the US.

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Speaker 2: Do you ever get frustrated? You probably need the market

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Speaker 2: because you need to raise money. It's a very costly

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Speaker 2: business developing drugs. As you just mentioned, you're spreading that

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Speaker 2: risk somewhat because your platform is it though, frustrating about

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Speaker 2: the ups and downs of the share price at times

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Speaker 2: simply on news which to you may well be expected,

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Speaker 2: but of course to investors who are waiting on every

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Speaker 2: word that Missoblast mentions. You know it can send your

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Speaker 2: share price up and down twenty or thirty percent. Is

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Speaker 2: it frustrating or is it just part of the gig look.

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Speaker 3: I've learned to accept it as part of the gig.

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Speaker 3: As you say, the frustration comes more from a lack

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Speaker 3: of understanding of the detailed pathway to approval and revenues

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Speaker 3: and that just comes with success. Really, But I think

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Speaker 3: you know, share price is not something that I should

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Speaker 3: be focusing on. My focus is on deliverables, on approvals,

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Speaker 3: on products in the marketplace, and revenues. That's really what

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Speaker 3: I focus most of my time on. And the vagaries

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Speaker 3: of the market will look after themselves when we deliver

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Speaker 3: and as we deliver, and I firmly believe that.

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Speaker 2: Sylvia, thank you for talking to Fear and Greed. Thank

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Speaker 2: you very much, Sylvia Tescu, founder and CEO of Miso Blast.

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Speaker 2: This is a Fear and Greed daily interview. Join me

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Speaker 2: every morning for the full Fear and Greed podcast with

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Speaker 2: all the business news you need to know. I'm sure

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Speaker 2: Alma enjoy your day.