Latest / Vanguards of Healthcare by Bloomberg Intelligence / ProKidney Aims to Stave Off Dialysis

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ProKidney Aims to Stave Off Dialysis · Vanguards of Healthcare by Bloomberg Intelligence

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  Speaker 1: Welcome to another episode of Bloomberg Intelligence's Vanguards of Healthcare podcast,
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  Speaker 1: where we speak with leaders at the forefront of change
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  Speaker 1: in the healthcare sector. I'm Anne Hunter van Kirk, Senior
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  Speaker 1: bio pharmaceutical analyst at Bloomberg Intelligence, the in house equity
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  Speaker 1: research division of Bloomberg. I'm very pleased to be welcoming
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  Speaker 1: today's guest, Bruce Cullton, CEO of Pro Kidney Corporation. Bruce,
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  Speaker 1: you started off as a clinician for a decade then
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  Speaker 1: medical devices. Tell us about the history of Pro Kidney
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  Speaker 1: and what brought you to the company.
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  Speaker 2: Well, first, age, I'd like to thank you for inviting
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  Speaker 2: me to be here. It's a pleasure looking forward to
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  Speaker 2: discussion over the next half hours. So what brought me
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  Speaker 2: to Pro Kidney's That's a little bit of a story,
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  Speaker 2: if you like. So. I've been in the kidney space
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  Speaker 2: for about thirty years. Originally I focused primarily on clinical
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  Speaker 2: research and seeing patients. I trained as a kidney specialist
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  Speaker 2: and for about nine to ten years I was in
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  Speaker 2: a practice, an academic type practice where I had the
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  Speaker 2: privilege of looking after patients directly. And I'd say that
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  Speaker 2: direct here and looking after patients really shaped me and
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  Speaker 2: how I think about business today in many immeasurable ways,
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  Speaker 2: I would say really patient focused. At some point in
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  Speaker 2: that time period, I recognized that the impact I was
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  Speaker 2: having was on a patient by patient basis, and there
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  Speaker 2: were things that I could probably do to have a
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  Speaker 2: greater impact within the kidney C space. And I'll talk
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  Speaker 2: a little bit about the kidney Z space why it's
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  Speaker 2: so important too, because I know your listeners might want
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  Speaker 2: to want to hear that. So an opportunity came by
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  Speaker 2: for me to work in a global role at Baxter Healthcare,
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  Speaker 2: a large medtech company. It took a few days, two
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  Speaker 2: weeks to make that tough decision to move from academics
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  Speaker 2: to industry, but I'd have to say after I made
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  Speaker 2: that move, I have no regrets. I do think the
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  Speaker 2: clinical exposure shaped me for sure, But after that move,
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  Speaker 2: I've been more than delighted with how the exposure I've
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  Speaker 2: gotten globally, but also just moving outside of direct clinical
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  Speaker 2: work to be able to work with people in finance,
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  Speaker 2: people of engineering backgrounds, people of strategic business backgrounds. It's
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  Speaker 2: really been able to open my eyes to look at
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  Speaker 2: problems in a very different way after that, I ended
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  Speaker 2: up working with another tech company back in Dickinson for
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  Speaker 2: a couple of years. But really I've got an opportunity
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  Speaker 2: to start a new company within CVS Health, a company
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  Speaker 2: called CVS Kidneycare, and that opened my eyes to healthcare services,
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  Speaker 2: to the payer world, to value based care, integrated care
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  Speaker 2: certainly helps me thinking about certainly helped me think about
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  Speaker 2: where I am today and how a product fits within
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  Speaker 2: the broader healthcare ecosystem and some of the solutions that
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  Speaker 2: you need to have in place to be successful within
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  Speaker 2: that world. And then finally I shift to Pro Kidney
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  Speaker 2: almost three years ago, actually it's just over three years
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  Speaker 2: ago now, And part of that shift was I really
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  Speaker 2: wanted to move away from the end stage or dialysis
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  Speaker 2: space space and have a larger impact on patients more upstream,
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  Speaker 2: with the goal of preventing patients from ending up on
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  Speaker 2: dialysis or even preventing patients from requiring a kidney transplant.
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  Speaker 2: And that was a real sort of impetus for me
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  Speaker 2: to move to a company like Pro Kidney, which was
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  Speaker 2: operating in that space.
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  Speaker 1: And what was sort of the background on Pro Kidney
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  Speaker 1: when you arrived, So I was.
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  Speaker 2: Quite Honestly, I'll say I was a skeptical optimist when
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  Speaker 2: a board member approached me to think about working at
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  Speaker 2: Pro Kidney, because, on the one hand, it sounded like
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  Speaker 2: science fiction that we were taking patients cells from their
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  Speaker 2: own kidney, growing them essentially further in a lab, and
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  Speaker 2: then injecting them back into the patient's kidney. That sounded
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  Speaker 2: a little far fetched, I'd say, the more I dug
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  Speaker 2: into the data, also speaking with some leaders in the
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  Speaker 2: field internationally and speaking to some people leaders at Pro
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  Speaker 2: Kidney at that time, I decided to jump in and
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  Speaker 2: I was and the reason for jumping in was was
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  Speaker 2: really around the potential for this to be transformative and
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  Speaker 2: how patients are treated.
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  Speaker 1: So with that, maybe start us off on the chronic
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  Speaker 1: kidney disease market. You know, what does the current landscape
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  Speaker 1: look like and where is pro Kidney going to revolutionize
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  Speaker 1: this market?
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  Speaker 2: So it's an exciting market. Thirty seven million Americans have
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  Speaker 2: chronic kidney disease. Now a smaller amount of those Americans
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  Speaker 2: end up requiring dialysis, just over one hundred thousand every
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  Speaker 2: year start on dialysis or need a kidney transplant, but
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  Speaker 2: certainly a large unmet need from a patient population, and
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  Speaker 2: also from an economic perspective, the cost of kidney care
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  Speaker 2: in the US today is about one hundred and fifty
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  Speaker 2: billion dollars annually. Arguably, it's one of the greatest unmet
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  Speaker 2: needs in healthcare, and that unmet need goes all the
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  Speaker 2: way from better tools to detech kidney disease early on
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  Speaker 2: to the other extreme, how do we improve the transplant space,
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  Speaker 2: how do we improve the care of patients on dialysis.
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  Speaker 2: What's happened over the last five to seven years has
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  Speaker 2: been really been a big change in how patients with
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  Speaker 2: earlier forms of kidney disease are treated. We've seen new
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  Speaker 2: products SGLT two's, gop one agonists, non selective MRAs, just
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  Speaker 2: to name a few treatments for igane aphropathy. We've seen
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  Speaker 2: new products actually come to market which are great for patients.
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  Speaker 2: They're improving patients outcomes, they're slowing down progression of chronic
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  Speaker 2: kidney disease. And even yesterday I was reviewing an article
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  Speaker 2: about patients who have genetic kidney disease, which is also smaller,
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  Speaker 2: more like orphan and kidney disease. There are forty three
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  Speaker 2: assets in development different phases of development for treating patients
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  Speaker 2: with different forms of genetic kidney disease. So we've really
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  Speaker 2: seen a big shift change over the last five to
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  Speaker 2: seven years. Before that, we probably went fifteen years without
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  Speaker 2: having a substantial new product on the market.
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  Speaker 1: Yeah, it was time and then getting into how pro
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  Speaker 1: kidney fits into this landscape.
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  Speaker 2: Yeah, so our focus is really on patients who've lost
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  Speaker 2: a lot of kidney function, seventy to seventy five or
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  Speaker 2: even eighty percent of their kidney function. Their EGFR, which
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  Speaker 2: was the measurement of their kidney function for our studies,
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  Speaker 2: is less than thirty five, So they've lost a lot
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  Speaker 2: of kidney function. They're on the path to needing a transplant,
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  Speaker 2: they're on the path to needing dialysis, and most of
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  Speaker 2: them are seeing kidney specialists because of that path that
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  Speaker 2: they're on. All the advances in treating patients with newer
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  Speaker 2: products over the last few years, patients continue to progress.
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  Speaker 2: So we're still seeing a lot of patients who continue
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  Speaker 2: to progress and are on that slippery slope towards dialysis.
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  Speaker 2: Our goal is that in that space directly performed analysis,
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  Speaker 2: how do we keep patients off of dialysis for a
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  Speaker 2: longer period of time? How do we preserve their kidney
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  Speaker 2: function with our product? Real parents, and I'll.
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  Speaker 1: Call them maybe tangential rivals. You mentioned some certainly, you know,
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  Speaker 1: everyone's always focused on how ozempic is going to play
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  Speaker 1: into a market, how will those impact pro Kidney's competitive opportunities.
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  Speaker 2: So first and foremost, I'll say, you know, purely from
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  Speaker 2: someone that's freet to patients, I think it's great for patients.
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  Speaker 2: I think now they have some options that they didn't
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  Speaker 2: have a few years ago. And ozempic, as an example,
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  Speaker 2: is not just good for kidney disease. It's all just
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  Speaker 2: shown to be better official for heart disease and cardio
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  Speaker 2: metabolic syndrome. So I think that's great for patients. The
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  Speaker 2: unfortunate thing is we also know that they're not cures,
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  Speaker 2: and patients will continue to progress, and the data shows
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  Speaker 2: that patients continue to lose kidney function, that's if they
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  Speaker 2: have access to the product. Even if they have access
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  Speaker 2: to the product, they still lose kidney functions. So we
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  Speaker 2: don't believe our market size is going to be demonstratably different,
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  Speaker 2: but we do believe that these are better products for patients,
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  Speaker 2: and patients, if anything, are going to be healthier if
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  Speaker 2: they are on some of these new products, and heart
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  Speaker 2: disease will be prevented in some cases of kidney failure
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  Speaker 2: will also be prevented.
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  Speaker 1: So they're really almost kind of you know, co comminant.
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  Speaker 2: Absolutely. So now I know we'll get into our clinical
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  Speaker 2: trial in a few minutes, but even within our pivotal
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  Speaker 2: phase three trial, our expectation is that when patients come
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  Speaker 2: into that study, they're already on what's considered standard of care.
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  Speaker 1: Fantastic and maybe before we dig into those trials a
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  Speaker 1: bit more. What would you just kind of outline as
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  Speaker 1: as ongoing investment in the space.
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  Speaker 2: Kidneys, in the chronic kidneysease space. I would be hesitant
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  Speaker 2: to give you a number, a dollar number, but I
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  Speaker 2: will say the investment is across an ecosystem of big Pharma, biogen, Vertex, Astrozeneka, Eli, Lilly,
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  Speaker 2: you name it, and they many of those have assets
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  Speaker 2: within the kidney disease space, all the way to startups
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  Speaker 2: that are really looking for cures for rare or genetic
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  Speaker 2: kidney disease, to a company like ours, where you know,
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  Speaker 2: we're somewhere in between. We've got two hundred and fifty employees,
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  Speaker 2: but we're very late stage. You know, we're a year
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  Speaker 2: from having a pivotal readout for a clinical study.
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  Speaker 1: A very interesting space and a lot of big players there.
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  Speaker 1: All right, so let's walk through you you have the
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  Speaker 1: phase two data, and of course we're expecting phase three
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  Speaker 1: data and not so long. Tell us what walk us
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  Speaker 1: through phase two and what we're looking for from phase three?
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  Speaker 2: Ye. Yeah, So it surround this time last year that
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  Speaker 2: we publicly disclosed our results from a phase two trial
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  Speaker 2: that we had completed a few months prior to that.
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  Speaker 2: I would say that I was pleasantly surprised when I
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  Speaker 2: saw the data. I didn't see the data along the way,
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  Speaker 2: even though it was open label. I saw the data
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  Speaker 2: when all the analysis is done, and I was pleasantly
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  Speaker 2: surprised at the difference in decline and kidney function that
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  Speaker 2: we saw on patients who were treated with our cell
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  Speaker 2: therapy product. And just to give you some numbers, in
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  Speaker 2: our regen Zeros seven study, before treatment, these patients who
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  Speaker 2: had diabetes and a dense chronic kidney disease, they were
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  Speaker 2: losing over five mls per kidney five mls permitted of
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  Speaker 2: kidney function per year. We see that advanced progression sometimes
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  Speaker 2: in patients who have diabetes. After treatment, we saw that
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  Speaker 2: decline actually come down to closer to what you'd expect
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  Speaker 2: in patients just having part of a normal aging process,
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  Speaker 2: a difference of about four point five mls per minute
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  Speaker 2: per year. That difference, if proven in our phase three study,
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  Speaker 2: would have a substantial impact on keeping people off dialysis.
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  Speaker 1: So would you say that's the bar you're looking for
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  Speaker 1: a four?
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  Speaker 2: Well, so if if we see that bar, then then
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  Speaker 2: you know we will knock it out of the park, right,
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  Speaker 2: So we've been really conservative in our assumptions around the
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  Speaker 2: Phase three design. Tell us about the design, yeah, And
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  Speaker 2: so in that design, we assume we've got two groups.
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  Speaker 2: There's a group that's randomly assigned to receive our cell
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  Speaker 2: therapy product, and then there's a group that's randomly signed
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  Speaker 2: to receive a placebo or sham product. And I'll tell
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  Speaker 2: you about how that works in a few minutes. But
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  Speaker 2: the assumption behind the powering of the study is that
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  Speaker 2: we're actually looking to detect the difference of one point
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  Speaker 2: five mls permit it not four point five. In fact,
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  Speaker 2: if it's as high as four point five, we could
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  Speaker 2: stop the study now and walk away and I'll feel
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  Speaker 2: really good about it. But we can't do that. So
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  Speaker 2: we've we've made a more conservative assumption, and this time
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  Speaker 2: next year, a little bit sooner than this, actually we'll
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  Speaker 2: be disclosing the data and if it is one point
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  Speaker 2: five mls permitted or greater, then we'll see a statistically different,
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  Speaker 2: statistically significant difference between the two groups. Now, just getting
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  Speaker 2: back to the design, just for a sec I don't mind.
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  Speaker 2: So if you are randomly assigned, patients are blinded, the
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  Speaker 2: investigators are blinded. But if you're randomly assigned to receive
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  Speaker 2: reparent cell, you will actually get a kidney biopsy. That's
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  Speaker 2: where we harvest the cells. That's done by an interventional
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  Speaker 2: radiologist in an IR suite using a CT scanner, so
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  Speaker 2: a very scripted process that we use for obtaining those cells.
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  Speaker 2: Those cells are transported back to our manufacturing facility in
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  Speaker 2: Winston Salem, North Carolina, and over the course of the
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  Speaker 2: next twelve weeks, those cells are exposed to so a
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  Speaker 2: digestion process, a growth process, eventually a selection process, and
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  Speaker 2: then a process where we test them to make sure
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  Speaker 2: that we can safely send them back to the patients.
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  Speaker 2: Once they pass that final release test, the cells will
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  Speaker 2: go back and radiologists again will reinject those cells in
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  Speaker 2: the same kidney that was biopsied, and then three months
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  Speaker 2: later a dose will also be delivered in the kidney
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  Speaker 2: that was not biopsied, so the Contralado kidney. If you're
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  Speaker 2: a patient who's assigned to the SHAM procedure, we need
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  Speaker 2: to be very careful to ensure that that patient doesn't
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  Speaker 2: know that they receive CHAM. Likewise, the patient to receive
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  Speaker 2: real parents SELL, we're very careful to make sure that
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  Speaker 2: they don't know they receive the actual drug product, and
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  Speaker 2: we go to great lens to make sure that the
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  Speaker 2: patient is blinded and the investigator is blinded. So that
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  Speaker 2: patient will go to an interventional radiology suite. They'll be
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  Speaker 2: met with the radiologist who's goallned and masked, supporting staff
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  Speaker 2: who's goalloned and masked, and that person will follow a script,
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  Speaker 2: and the patient who's in that arm of the study
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  Speaker 2: may even receive conscious sedation to make them less nervous.
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  Speaker 2: They'll get a little nick in the skin. The radiologist
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  Speaker 2: follows the script, the patient goes to a recovery room
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  Speaker 2: for four to six hours, and they go home assuming
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  Speaker 2: that they receive the real product. And that's really important too,
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  Speaker 2: to ensure that the results that we see are valid
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  Speaker 2: and not impacted by a bias created by patients knowing
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  Speaker 2: what product they received.
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  Speaker 1: Sure. Sure, So you you walked us through you know
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  Speaker 1: a lot of detail there on the on the cell collection,
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  Speaker 1: and that's certainly an area that's been a struggle for
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  Speaker 1: many gene companies doing therapy companies, you know, can you
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  Speaker 1: outline for us? You walk us through the process. But
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  Speaker 1: why is that easier?
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  Speaker 2: So it's it's I'd say it's it's a little easier
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  Speaker 2: for us than some other companies that are in cell
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  Speaker 2: therapy space. One one piece of the puzzle is that
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  Speaker 2: we don't have to precondition patients, so patients don't have
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  Speaker 2: to be exposed. Let's say, if it's a cancer patient
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  Speaker 2: receiving carte therapy patient just in our in our study,
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  Speaker 2: in our future commercialization, that patient doesn't need to be
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  Speaker 2: exposed to medications that would potentially provide substantial side effects.
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  Speaker 2: So there's no pre treatment, there's no preconditioning. And then
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  Speaker 2: on the other side, once the cells, because there are
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  Speaker 2: the patient's own cells, each product is unique to that patient,
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  Speaker 2: so the patient doesn't have to receive any anti rejection
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  Speaker 2: medications as well, so that makes it simpler on the
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  Speaker 2: patient side. But like all cell therapy manufacturing, it has
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  Speaker 2: its own complexities. We don't use any viruses or genetics
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  Speaker 2: or anything like that. But even though it's a it's
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  Speaker 2: it's on paper it looks like it could be viewed
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  Speaker 2: as a relatively straightforward process, there's a lot of complexity
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  Speaker 2: to it, and we have to make sure that our
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  Speaker 2: manufacturing process is can assistant from product to product to product,
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  Speaker 2: and that obviously creates a complexity when most of it
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  Speaker 2: is a manual process.
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  Speaker 1: Today and this is probably getting ahead of ourselves, but
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  Speaker 1: is that scalable and how how will you scale that?
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  Speaker 2: So if you think of the potential size of the
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  Speaker 2: patient population that we can treat in the US, it's
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  Speaker 2: probably close to a million patients. So know that manual
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  Speaker 2: process is not capable, not in a cost efficient way.
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  Speaker 2: So it is suitable for what we're doing today. But
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  Speaker 2: we are working on and we anticipate that in the
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  Speaker 2: future there will be automation that's brought into our process
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  Speaker 2: that has to be validated, tested and validated. But we
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  Speaker 2: do believe that that automation, like many cell therapy companies
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  Speaker 2: are shifting to, is going to be a needed requirement
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  Speaker 2: for us to be successful.
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  Speaker 1: That makes sense, And so looking then a bit more
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  Speaker 1: at the pricing, I'm sure there's still a lot of
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  Speaker 1: work to do, but we're certainly seeing a lot of
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  Speaker 1: discussion in the industry on an outcomes based model. How
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  Speaker 1: does that factor in to your development and these commercialization plans.
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  Speaker 2: Well, I understand the industry moving to outcomes based models
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  Speaker 2: for sure, And even my background when I worked at CVSSTNA,
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  Speaker 2: there was a lot of work in that space, even
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  Speaker 2: in the kidney space at that time, through value based
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  Speaker 2: care type service models. So it definitely makes sense that
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  Speaker 2: the industry is moving in that perspective. Now for us,
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  Speaker 2: we're a little too early for me to say this
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  Speaker 2: is what our price is going to be or what
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  Speaker 2: our pricing models is going to be. But all those
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  Speaker 2: outcomes models models are based on value creation. And so
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  Speaker 2: where I can tell you where the value that we'll
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  Speaker 2: be creating is primarily by keeping people out of a
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  Speaker 2: dialysis unit. Sure, and the cost of looking after a
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  Speaker 2: dallasis patient For a payer, I'll use Medicare advantage as
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  Speaker 2: an example, So a dalysis patient with a Medicare who's
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  Speaker 2: a Medicare advantage member will cost Medicare anywhere from one
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  Speaker 2: hundred and thirty thousand to two hundred and fifty thousand
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  Speaker 2: dollars per year. So the value that we can create,
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  Speaker 2: you know, is more complicated than the say saying we're
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  Speaker 2: saving one hundred and thirty or one hundred and fifty thousand
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  Speaker 2: dollars a year. But that's one component of it. And
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  Speaker 2: then if we can keep patients working, if we can
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  Speaker 2: reduce their transportation costs, if we can reduce some of
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  Speaker 2: their other medications they have, hospitalizations, et cetera, there's a
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  Speaker 2: whole value stream that we believe we can have an
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  Speaker 2: impact on by just keeping people out of the dialysis ut.
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  Speaker 1: Absolutely. So yeah, so you mentioned, you know, the benefit
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  Speaker 1: to the payers and the patient's perspective. Let's really drill
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  Speaker 1: down there is what is the incentive here over the
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  Speaker 1: traditional dialysis the incentive for a patient, for payers and
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  Speaker 1: patients I see.
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  Speaker 2: So I think I think the incentive for a payer.
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  Speaker 2: First of all, payers do want to keep their members
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  Speaker 2: for a long period of time. So despite many of
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  Speaker 2: the challenges, I think that we see within the payer
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  Speaker 2: landscape today they do like to retain their members, but
• 21:17
  Speaker 2: they also want to reduce their costs. Sure, and so
• 21:20
  Speaker 2: you know, if we're able to stop or preserve kidney function,
• 21:24
  Speaker 2: then there's a very easy equation to to say yes,
• 21:27
  Speaker 2: where we should be able to save them cost depends
• 21:30
  Speaker 2: on our price, right obviously, But the goal is for
• 21:33
  Speaker 2: us to create value not just for ourselves but also
• 21:36
  Speaker 2: for the payers. So for the payers, I think it's
• 21:39
  Speaker 2: cost membership loyalty to some degree as well. For an
• 21:44
  Speaker 2: advanced therapy be like we have. There also might be
• 21:47
  Speaker 2: some exclusivity in actually having that as part of an
• 21:51
  Speaker 2: offering if you're a payer as well. For patient, it's
• 21:56
  Speaker 2: it's it's more complex, right, It's it's emotional from any patient.
• 22:01
  Speaker 2: If we did some pay research, pay research, some patient
• 22:05
  Speaker 2: research recently, and an overwhelming reaction to our product was
• 22:10
  Speaker 2: if this works, this will be game changing for us,
• 22:13
  Speaker 2: for me, for our family. And the reason is is
• 22:17
  Speaker 2: that once you end up on dialysis, for most patients,
• 22:22
  Speaker 2: your life changes.
• 22:25
  Speaker 1: Amy for our listeners tell us, you know what the
• 22:27
  Speaker 1: average dialysis that needs to go through, So.
• 22:33
  Speaker 2: When you start dallasis you need something to call vascular access,
• 22:36
  Speaker 2: So that's a surgery. That's the way that the nurses
• 22:40
  Speaker 2: within a dialysis clinic can take blood from your body
• 22:43
  Speaker 2: and run it through a machine. Most patients are treated
• 22:46
  Speaker 2: at a center or facility, and those treatments are three
• 22:50
  Speaker 2: to four hours, three times per week. You need to
• 22:53
  Speaker 2: get there and then by the time the treatment is over,
• 22:56
  Speaker 2: you need to get back home. Most patients feel so
• 22:59
  Speaker 2: washed out that they're not able to work or study
• 23:02
  Speaker 2: the day of their dialysis, and some patients that feeling
• 23:07
  Speaker 2: of being washed out even goes on into the next day.
• 23:10
  Speaker 2: Travel becomes a lot more difficult, tending life events, taking
• 23:16
  Speaker 2: kids to college, going to weddings, you know, things that
• 23:21
  Speaker 2: we all consider just normal, going on vacation for some
• 23:25
  Speaker 2: of us, that becomes so much more challenging if you're
• 23:28
  Speaker 2: tied to a dialysis here. And the other thing about
• 23:33
  Speaker 2: dialysis is that the outcomes are bad. You know, the
• 23:36
  Speaker 2: median mortality I think for Dallasis patients in the US
• 23:40
  Speaker 2: is about two and a half to three years. So
• 23:42
  Speaker 2: the outcomes are really poor, and the innovation that's happened
• 23:45
  Speaker 2: in that space over the last thirty years has really
• 23:49
  Speaker 2: not been optimal. I can't remember if I shared this
• 23:52
  Speaker 2: with you in the past, But I went to period
• 23:58
  Speaker 2: because I wasn't treating patients. I went a period of
• 24:01
  Speaker 2: about fifteen years before I actually was in between seeing
• 24:05
  Speaker 2: patients in a dialysis hit and fifteen years when I
• 24:09
  Speaker 2: went to visit a Dallas clinic in Boston a few
• 24:11
  Speaker 2: years ago. When I moved back to Boston. It was
• 24:13
  Speaker 2: about fifteen years in between visits to Dallas clinic. Two
• 24:19
  Speaker 2: things changed. When was the seats they were clying e
• 24:23
  Speaker 2: chairs or better. And the other was flat screen TV.
• 24:26
  Speaker 1: Oh dear.
• 24:27
  Speaker 2: Everything else looked the same. Yeah, And I don't think
• 24:31
  Speaker 2: the treatment really changed.
• 24:32
  Speaker 1: Wow.
• 24:33
  Speaker 2: And so there's been really an absence of innovation within
• 24:38
  Speaker 2: that dialysis space. If we can keep people out of that,
• 24:43
  Speaker 2: we will have an enormous impact.
• 24:45
  Speaker 1: That's fantastic, Bruce, Thank you. We dug into the science
• 24:49
  Speaker 1: on the cell collection. Can we dig into the delivery
• 24:53
  Speaker 1: a little bit? It's an injection the same kidney first,
• 24:56
  Speaker 1: is there? What's the reason behind that? And tell us
• 25:00
  Speaker 1: about the delivery mechanism.
• 25:01
  Speaker 2: Yeah, so that's a good question. What's the reason behind it?
• 25:04
  Speaker 2: It's more of a regulatory rationale. I think, you know,
• 25:08
  Speaker 2: when pro kidney started some of the earlier studies, the
• 25:12
  Speaker 2: FDA appropriately cautioned the company that, you know, you don't
• 25:16
  Speaker 2: want to do something where patient might lose both kidneys,
• 25:19
  Speaker 2: because that means they're going to end up on analysis.
• 25:21
  Speaker 2: So early on it was okay, you biopsy one kidney.
• 25:25
  Speaker 2: If the patient is still good after the biopsy, which
• 25:27
  Speaker 2: is an accepted procedure that's done today, then you can
• 25:30
  Speaker 2: inject that kidney, and then you can inject that same
• 25:33
  Speaker 2: kidney three to six months later. So that evolved as
• 25:37
  Speaker 2: our safety data became more wholesome, that evolved to us
• 25:42
  Speaker 2: being allowed to inject one kidney and then the other
• 25:46
  Speaker 2: kidney three months later. So that's how that happened over time.
• 25:50
  Speaker 2: And then the injection procedure for an internntial radiologist, it's
• 25:55
  Speaker 2: pretty straightforward, to be honest. You know. It's a volume
• 25:59
  Speaker 2: of fluid of cells of anywhere from two to four
• 26:03
  Speaker 2: mls primarily, maybe a little bit bigger in some patients
• 26:07
  Speaker 2: who might have larger kidneys. It's done over twenty to
• 26:11
  Speaker 2: thirty minutes. There's a needle that a syringe where the
• 26:15
  Speaker 2: cells are contained as fine needle that's put into in
• 26:19
  Speaker 2: through the patient's back into the outerlining of the kidney cortex.
• 26:23
  Speaker 2: That's it. So it's actually for radiologists. It's a pretty
• 26:25
  Speaker 2: straightforward procedure.
• 26:28
  Speaker 1: And tell us about your I know when you started,
• 26:31
  Speaker 1: you actually cut some trials that weren't needed by the FDA.
• 26:36
  Speaker 1: Tell us about about that process and kind of your
• 26:39
  Speaker 1: x US focus.
• 26:41
  Speaker 2: So we've done two two phase two studies. So since
• 26:46
  Speaker 2: I've been CEO, we've reported on two Phase two studies.
• 26:49
  Speaker 2: One I mentioned to you earlier. That was certainly the
• 26:52
  Speaker 2: most interesting one because we followed the same treatment process,
• 26:57
  Speaker 2: the same formulation of a parent cell that we have
• 27:00
  Speaker 2: in our phase three study. So that's the most informative one.
• 27:04
  Speaker 2: The other one was another was another phase two study,
• 27:08
  Speaker 2: a few more patients. I think we had eighty two
• 27:10
  Speaker 2: patients in the other phase two study. That one's a
• 27:13
  Speaker 2: little bit more complicated. It started just before COVID. The
• 27:18
  Speaker 2: team in place at that time did an amazing job
• 27:20
  Speaker 2: to actually continue to study during covidet to get into
• 27:25
  Speaker 2: hospitals like talk to them about this, like I can't
• 27:29
  Speaker 2: believe they were actually able to do that. Coming from
• 27:32
  Speaker 2: that study, what we saw was a preservation of kidney
• 27:35
  Speaker 2: function over about eighteen months. We also saw on patients
• 27:38
  Speaker 2: who were the highest risk of kidney failure that they
• 27:41
  Speaker 2: seem to do better, and so we ended up revising
• 27:45
  Speaker 2: our Phase three program based upon that data that came
• 27:48
  Speaker 2: from a Phase two program that was going on simultaneously.
• 27:52
  Speaker 2: And then you also asked about outside US.
• 27:55
  Speaker 1: Because that was an x US study, right.
• 27:57
  Speaker 2: No, both of those both of those studies were were
• 28:00
  Speaker 2: conducted in primarily in the US.
• 28:04
  Speaker 1: Were the ex US sites. There were some that you
• 28:08
  Speaker 1: ended right that were no longer necessary, correct.
• 28:11
  Speaker 2: So we had designed a Phase three program to be
• 28:14
  Speaker 2: conducted outside the US, and that was a large Phase
• 28:19
  Speaker 2: three study which almost mirrored the Phase three program that
• 28:22
  Speaker 2: we're running primarily in the US. And before we had
• 28:27
  Speaker 2: some sites who are about ready to be qualified, who
• 28:30
  Speaker 2: are going to start screening for patients a very costly
• 28:35
  Speaker 2: study under ARMAT, which is our designation we have with
• 28:39
  Speaker 2: the FDA, we were all to have a we were
• 28:42
  Speaker 2: able to have a discussion with the FDA around do
• 28:44
  Speaker 2: we really need that second study, and they confirmed with
• 28:48
  Speaker 2: us that for eventual approval in the US, we would
• 28:52
  Speaker 2: not need that second study, assuming that the one study
• 28:55
  Speaker 2: that we're conducting primarily in the us was conducted in
• 28:58
  Speaker 2: the right way, so we actually ended up stopping that
• 29:02
  Speaker 2: other phase three study and the funds that we had
• 29:08
  Speaker 2: to support that allowed us to extend our cash runway,
• 29:12
  Speaker 2: which gives us an opportunity for a readout before we
• 29:15
  Speaker 2: run out of money, which.
• 29:16
  Speaker 1: Is a fantastic position to Blingeon and something that I
• 29:19
  Speaker 1: wish all my companies were more focused on. So tell
• 29:24
  Speaker 1: us about where you think cash can take you and
• 29:28
  Speaker 1: maybe sort of you know, how you plan to get
• 29:30
  Speaker 1: to the next level, whether that's you know, going on
• 29:35
  Speaker 1: your own partnership, what do you see as the commercialization opportunity?
• 29:40
  Speaker 2: Yeah, for sure. So first of all, I'll say that
• 29:42
  Speaker 2: we've made substantial progress in our study. Any day soon
• 29:48
  Speaker 2: we'll stop screening patients. Great, we will stop the official
• 29:52
  Speaker 2: enrollment process within the coming months, and we anticipated readout
• 29:57
  Speaker 2: from the data for an EXCEL tolerated approval pathway in
• 30:03
  Speaker 2: the second half of next year, so late second half,
• 30:05
  Speaker 2: So we're within twelve months, and that's really exciting for
• 30:08
  Speaker 2: a biotech company to say that we're within twelve months
• 30:11
  Speaker 2: and we have cash to get us there. So we're
• 30:16
  Speaker 2: excited about that. Where we're eventually going to go from
• 30:20
  Speaker 2: a commercialization perspective, So our focus on the US primarily
• 30:26
  Speaker 2: on the US. You know, obviously there's an unmitt need
• 30:30
  Speaker 2: outside the US, but we're not going to be able
• 30:33
  Speaker 2: to initially meet the demand in the US right and
• 30:36
  Speaker 2: so there are regulatary challenges outside the US. The FDA,
• 30:40
  Speaker 2: for all its you know warts that we hear in
• 30:43
  Speaker 2: the media, actually is a very efficient organization when it
• 30:48
  Speaker 2: comes to new product approvals. So we're working in a
• 30:52
  Speaker 2: highly efficient, i think, regulatory environment within the US and
• 30:56
  Speaker 2: that's our focus. Our focus on solving this primary early
• 31:00
  Speaker 2: for patients in the US and expand here we you know,
• 31:05
  Speaker 2: should we should we be successful, I think there will
• 31:08
  Speaker 2: be other international companies that would be interested in what
• 31:11
  Speaker 2: we're doing to help meet some of that unmet need
• 31:14
  Speaker 2: outside the US, and we'd certainly be open for those discussions.
• 31:18
  Speaker 1: Fantastic, Well, Bruce, what else would you like to leave
• 31:22
  Speaker 1: our listeners with today?
• 31:25
  Speaker 2: I guess the only thing I'd say is that, you know,
• 31:29
  Speaker 2: this comes down to and an inflection point for our company.
• 31:35
  Speaker 2: But I'll say that that even though we see the
• 31:40
  Speaker 2: potential business opportunity that's coming here, I never want us
• 31:46
  Speaker 2: to lose sight as a company, nor people that are
• 31:51
  Speaker 2: working with us that the transformative nature that this could
• 31:55
  Speaker 2: have on patients, and this could really have a big
• 32:00
  Speaker 2: impact on just how patients live and how they survive,
• 32:06
  Speaker 2: how they enjoy life, and the hope that we could
• 32:10
  Speaker 2: potentially provide them again. You know, cross our fingers that
• 32:15
  Speaker 2: in less than a year from now will have a
• 32:16
  Speaker 2: good answer.
• 32:18
  Speaker 1: Fingers are certainly crossed, and this is an exciting place.
• 32:21
  Speaker 1: Thank you for speaking with us today, Varus. I'm Ann
• 32:25
  Speaker 1: Hunter van Kirk, and you've been listening to the Vanguards
• 32:27
  Speaker 1: of Healthcare podcasts by Bloomberg Intelligence fall along to make
• 32:31
  Speaker 1: sure you never miss a discussion with the leaders in
• 32:33
  Speaker 1: healthcare innovations.