1. “We’re in the middle of a pandemic, and people are talking about opening up, and they’re talking about a potential second wave,” Itescu said. “It’s too early to talk about projections, but we need to at least be in a position to make more product in an additional facility, so that requires technology transfer and certain process improvements.”
2. “There are at least 125,000 patients every year in the United States with influenza-related acute respiratory distress syndrome in intensive care units, and those patients have got about a 40% fatality rate. Up to about 60,000 patients die per year due to influenza ARDS, so even if COVID-19 magically disappears, which we could only hope, influenza is here to stay despite vaccines being available,”
3. “We’re putting our strategic plan into play. You need to have multiple geographies, especially in this kind of environment,” Itescu said.“Without the cash, we wouldn’t have been able to deliver on this, but we now can execute.”
The following stood out for me (basically the whole transcript):
1. "So how long do you think it'll take for the clinical trial on COVID-19 to be done and completed?
We think it'll take about three months of enrolment. So three months to enrol. And then all the patients have got to complete at least 30 days of follow up and then we'll read out the trial. Now along the way, we will have some interim analyses, so it's possible that we'll have some top level data sooner."
2. "How many of the cells do you inject either for COVID-19 or for the other conditions you're treating?
Yeah, we've got a standard protocol now, and that's the protocol that we use to treat patients with acute Graft Versus Host Disease, which is 2 million cells per kilogram body weight twice in the first five days or so. For diseases like GVHD or Crohn's disease, we continue to treat for about four weeks intravenously in order to put these patients into remission. For coronavirus lung disease, just the two doses in the first five days appears to be sufficient as a protocol, to make a substantial difference and get these patients off ventilators. That’s certainly the protocol that we used in the first 12 patients, that will be the protocol in our Phase III trial."
3. "Well, COVID-19 is an inflammatory lung disease, isn't it? Or at least a lung condition, apart from anything else?
Well, it turns out that the virus infects the lining of the airways and the immune system then comes into your healthy lungs in order to try to eliminate the virus and you have sort of a very severe battle going on in your lungs where multiple arms of the immune system are secreting cytokines, factors that typically act to dampen down the virus. And unfortunately, what happens is that as a bystander, your lungs are a target of these cytokines and you get a lot of destruction of your normal lungs. What our cells do is they're the body's natural control mechanism for excessive inflammation, if you will. They have receptors for these aberrant cytokines and when you put them in the middle of, what's called a cytokine storm, they're activated by these immune cytokines and then they turn off the very cell that secreted them.
So our cells are able to control multiple arms of the immune system simultaneously. And so diseases where multi-cytokine production is at the core of the disease process, are ideal for management with our cells. Graft Versus Host Disease is one of those diseases. Coronavirus lung disease is another one of those diseases, right? So that's what the mechanism of these diseases have in common that our cells are able to be useful for. When you inject our cells intravenously, the first place where they migrate to, are the lungs. So inflammation in the lungs is an ideal target for Remestemcel-L. Beyond COVID-19, other causes of inflammation in the lungs that we will be seeking to address, including influenza virus, influenza respiratory distress syndrome, which is a major problem, 60,000 people a year in the United States alone die from influenza-related acute respiratory distress syndrome in the Intensive Care Unit. So that's a big unmet need.
As well, as I mentioned earlier, chronic lung disease, obstructive airways disease, which is aggravated by inflammation such as occurs, for example, with influenza virus on a seasonal basis. So there are a number of severe inflammatory conditions of the lungs that I think our cells would be applicable for. But we're starting by addressing COVID-19 ARDS."
4. "And how do you manufacture these cells?
At the moment we're manufacturing in Singapore under contract with the world's leading biologics manufacturer, Lonza, who have a very large plant in Singapore. That plant has got already FDA approval for other treatments for monoclonal antibodies. And we hope it will get approval to make ourselves for the FDA for the US market. Obviously for COVID-19 lung disease, which is a real big, much larger unmet need, for example, than GVHD many, many more patients, we need to now think about increasing the production. And we'll do that in the Lonza site in Singapore as well as we're looking at sites in the United States. And we're talking to the US government around the potential for the government to support our manufacturing requirements in terms of investment both at the level of capacity and at the level of supply purchase."
5. "So are these cells expensive to make, I mean, you're obviously injecting 100-200 million cells or so per patient. Is that an expensive treatment? What are we talking?
Look, we're working at the moment in our first generation production, we're talking about 60 per cent gross margins, that sort of thing. So, you know, we have a commercial business opportunity that is clearly feasible and we have proprietary manufacturing technology that will substantially increase the yield and reduce the manpower required for production. We've got proprietary media, we've got use of novel technologies including bio-reactors. And so we've got ways of increasing the production levels by anywhere from 10 to 20-fold that will substantially increase capacity and reduce the cost of goods and obviously have a great impact on gross margins. So we’re well positioned to meet the supply."
6. "But are we talking a $100 a treatment or $1,000 or $10,000? What’s the ballpark?
It’s not a question of what's the cost. Well, it’s the same ballpark as you would expect for patients with severe disease. I mean, you know, it depends if we're talking about a very rare disease that kills you versus a very common disease that's chronic, right? I mean, there are diseases in the United States, particularly where a cure, which is what we're talking about, right, for Graft Versus Host Disease, a four week treatment is effectively a cure that will put children into long term remission and even cure. And we've got patients 15 years later are Harvard Medical School students, right?
So we're talking about curing of these diseases. You know, the ultra-orphan indication in the US reimburses very highly for orphan indication because they significantly impact outcomes. For example, you know, unfortunately a child who dies from Graft Versus Host Disease in the US system, will spend several months in Intensive Care, and will cost the healthcare system about $1.5 million dollars more than a child who has the same disease but survives, right?
So if we can save the healthcare system $1.5 million dollars by obviously making sure the child survives, not only is that important as an outcome, but it's economically very important for the hospital and for the healthcare payer. When you have those kinds of differences in outcomes, it's a negotiation to be had and we can justify with an appropriate pricing. But that's a commercial discussion that ultimately is a negotiation between the company, the healthcare payers, the hospitals, and you find a middle ground where basically everybody finds a place that they’re comfortable with.
Most importantly, reimbursement and payments are related to clinical outcomes and if somebody is alive and well and thriving for the rest of their lives, you've really impacted them. It's going to be exactly the same with coronavirus. It’s kind of being said that the people most susceptible to coronavirus, in fact, are the elderly. But that's not what we're seeing actually in our experience now in Intensive Care. Fifty per cent of the patients that have received our cells, the average age was about 50 years old. That's not old at all.
In other words, half the patients who have received our cells were in their 30s and 40s. So we're seeing quite a diverse range of ages and if you can save a life it's not just about how much time are you saving from Intensive Care, but the impact you’re having for the rest of their life. And obviously that's reimbursed in a certain way as opposed to at the end stage of life. A very different way of looking at mortality benefits."
Have a good one.
MSB Price at posting:
$3.67 Sentiment: Buy Disclosure: Held
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