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Plus Therapeutics is a clinical-stage pharmaceutical company developing targeted radiotherapeutics with the potential to enhance clinical outcomes in patients with difficult-to-treat cancers of the central nervous system. The company’s technology allows for extremely precise radiotherapeutics.

The company recently presented data at the Society for Neuro-Oncology Conference in San Francisco. Early results from ongoing studies of the company’s lead drug candidate showed extremely promising responses from patients in phase 1.

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Transcript
00:00
00:04 Welcoming in Dr. Mark Hedrick.
00:06 He is MD, President and CEO of Plus Therapeutics.
00:09 Dr. Hedrick, it's great to have you with us this morning.
00:11 Thank you so much for joining us.
00:12 Hey, Michael. Good morning. Great to be here.
00:15 Pleasure to have you here, Dr. Hedrick.
00:16 Let's go ahead and kick things off.
00:17 We've talked with you guys at Plus Therapeutics
00:19 many times over the past few months
00:21 and even years now, I believe.
00:23 But let's kick things off with a brief introduction
00:25 to the company. Tell us a little bit about
00:26 Plus Therapeutics and what you do.
00:29 Yeah, Michael. We're a biotech company.
00:30 We develop targeted radiotherapeutics.
00:33 Little nuclear bombs in a way that go right to the tumor,
00:36 only kill the tumor and kill nothing else.
00:38 And we're going after CNS cancers,
00:41 central nervous system cancers, brain cancers,
00:43 which are some of the most deadly cancers out there,
00:46 and we have very poor options for them.
00:49 Understood. So can you maybe give us a little bit
00:51 of the gravity of the overall breadth
00:54 and just widespread nature of this problem
00:56 that you're looking to address?
00:57 I think that it may be one of those things
00:59 that's not discussed so frequently
01:00 because of the technical nature of how you're solving it.
01:03 But give us maybe a sense of how many people are impacted
01:05 by this issue that you're looking to solve.
01:08 Well, one reason we're on this morning
01:09 is we want to talk about some data we released.
01:11 I'm here in San Francisco at the Society for Neuro-Oncology
01:14 American Society of Clinical Oncology meeting,
01:17 and we presented data this morning
01:18 for a central nervous system cancer
01:21 called leptomeningeal metastasis.
01:24 It's on the rise.
01:25 It affects about 150,000 patients per year,
01:28 but it's probably two to four times underdiagnosed,
01:31 so maybe as many as a half million patients.
01:34 And it's what happens when a woman may have breast cancer
01:37 or a man with lung cancer, for example.
01:40 We might have good local control of the tumor,
01:42 but it pops up into around the brain, the spinal fluid,
01:46 and then there's no good treatment.
01:47 These patients die in four to six weeks without treatment
01:51 and just a few months even with treatment,
01:53 and there's nothing approved by the FDA.
01:56 I think you have a slide up right now.
01:57 You can see the disease on the left,
02:00 and on the right is our drug.
02:01 You're actually seeing our drug in real time
02:03 in the colored images where we put a small port
02:07 in these patients' skulls.
02:09 We have direct access to the central nervous system,
02:12 and we put our drug, which is a targeted radiotherapeutic
02:16 that is made in a nuclear reactor.
02:18 It's called rhenium abyss pomada,
02:20 and then it essentially circulates rapidly
02:22 within minutes.
02:23 It sterilizes the central nervous system
02:26 and spinal fluid by circulating in that space
02:29 and stays there for well over a week
02:32 with a single five-minute administration in the clinic.
02:36 >> Understood.
02:37 Okay, so can you maybe lay out a couple of next steps for us?
02:40 This is really exciting news, and we're obviously very pleased
02:43 to have the chance to have you on and talk about it
02:45 when it's so recent here.
02:46 But let's talk a little bit about what this means
02:48 for Plus Therapeutics and what you're going to do next.
02:50 What does this set you up for,
02:51 and what really excites you about this opportunity
02:53 as you release this data?
02:55 >> Well, there's another slide, if you could show that.
02:57 That'll help illustrate about why we're so excited about this,
03:01 and I'll tell you what our next steps are.
03:03 So this is phase one data.
03:06 On the left, it shows the decrease in cell count.
03:09 So we can actually-- because we have access
03:11 to the central nervous system, which is very unique,
03:14 we have access to the fluid.
03:16 We can take the fluid out at any time during the follow-up.
03:19 We can assess exactly how many tumor cells
03:22 are in the spinal fluid.
03:24 So what you see in this graph on the left
03:27 is a 50% to 90% reduction in tumor cells
03:30 after a single dose-- in fact, a very low dose--
03:33 that persists for a month with a single administration.
03:36 So that's excellent news.
03:38 It shows biologic response, which is what you want to see.
03:41 Very unusual to see that in a phase one dose escalation trial.
03:44 But the real money is on the right side.
03:47 As I mentioned, these patients live a few weeks
03:49 or a few months.
03:50 We show that in the first patients we've treated,
03:52 single administration, the overall survival
03:55 is at 10 months.
03:56 So we have five patients that are still alive.
03:58 So very unusual in a phase one to see biologic response
04:02 and a survival response, but also a great safety profile.
04:07 So we're really excited to continue
04:09 to find the maximum dose, add multiple doses,
04:13 and maybe turn this fatal disease into a chronic disease
04:16 or maybe even have some cures.
04:18 Or if patients are going to succumb to their disease,
04:21 it won't be because of their central nervous system disease.
04:23 It might be the disease somewhere.
04:25 But this could be a major step forward for these patients.
04:29 >> Outstanding.
04:30 And I'm also aware that you guys are participating
04:32 at the SNO, ASCO, CNS Cancer Conference right now
04:35 on the 10th through the 12th out in San Francisco.
04:38 What's being discussed out there?
04:39 And is this data that you've just released
04:41 coming up as a prevalent point that you're discussing?
04:43 And what's the feedback maybe that you might be hearing
04:45 about what you've just released?
04:47 >> Yeah, if you could put up the next slide, Michael,
04:49 that'd be great.
04:50 So yeah, we're here at the Society for Neuro-Oncology
04:52 meeting.
04:53 It's an annual brain metastases meeting.
04:55 And one of the things that is on everybody's mind
04:58 is the fact that, I sort of mentioned it before,
05:01 that we're able with new drugs and immuno-oncology therapies
05:05 and new small molecule therapies,
05:07 we're able to control cancers like melanoma,
05:10 breast cancer, and lung cancer.
05:13 The problem is even though you have local control,
05:15 it pops up and it pops up in the central nervous system.
05:18 That's a shielded, protected environment in the body.
05:21 And so there's a lot of excitement now
05:23 because we're so good at controlling the primary disease.
05:27 Now doctors can pivot to this very important,
05:30 growing complication called leptomeningeal disease.
05:33 And target radiotherapeutics are really taking off.
05:36 There've been three really major drugs
05:37 that have been launched relatively recently.
05:40 So we're right at the cusp of this new direction
05:44 towards going after these CNS applications,
05:48 but also in the targeted radiotherapeutic space,
05:50 which is also very hot.
05:53 >> Wonderful.
05:54 So let's take a little bit more of a longer term approach
05:56 here too as we start to wind down with the data
05:59 that you've just released, the exciting path that you're on,
06:01 the progress that you've made, especially recently.
06:03 What do these next few years look like for Plus Therapeutics?
06:06 What are you going to do on the development side?
06:08 What is that path forward going to look like?
06:09 And if you take a snapshot of the company two, three,
06:12 four years from now, where do you see yourselves
06:14 being at Plus Therapeutics?
06:16 >> Yeah, so from a development perspective,
06:18 we're a small micro-cap company,
06:21 but we actually, we're very frugal.
06:23 We fund our trials through grants.
06:25 So the leptomeningeal cancer drug that I just showed you
06:28 is funded by approximately $18 million
06:32 by the state of Texas.
06:33 We have another indication using the same drug
06:36 for glioblastoma, which is primary brain cancer,
06:39 a rare disease, and we're actually in phase two.
06:42 And that's funded by the National Cancer Institute.
06:45 So we're able to take these kind of first-in-class,
06:48 CNS-focused, targeted radiotherapeutic drugs
06:52 and get outside sources of capital,
06:55 which allows us to minimize dilution,
06:57 but drive these things forward.
06:59 And by phase two, you effectively know
07:01 what's going to work or not.
07:02 So we're in a position where we have two co-lead indications
07:06 that are multibillion-dollar opportunities.
07:08 We're going after, in aggregate,
07:10 opportunities that are $8 to $10 billion.
07:12 They're unmet medical needs, horrible prognosis,
07:16 and really in need of new drug opportunities.
07:18 So the next three years or so for us
07:20 is getting these drugs through phase two,
07:22 potentially partnering them with larger companies.
07:25 There's a number of new public companies
07:27 that are looking for drugs in their mid-stage pipeline.
07:30 We think these are two assets
07:31 that are going to be very attractive for partnering
07:33 while we continue to develop new drugs
07:35 and new opportunities in our pipeline
07:37 and sort of our grant-funded development model.
07:42 - That's terrific. Great breakdown there.
07:44 And I want to make it even just a little bit more granular here
07:46 as we close out with the final question.
07:48 For retail investors, right, in our audience,
07:50 you just talked about the dilution opportunities
07:52 this gives you and the way that you're able to raise capital,
07:54 how you're funding through grants.
07:56 For retail investors, in our following specifically,
07:58 right here, what does this data mean
08:00 and why should they be paying such close attention
08:02 to Plus Therapeutics right now,
08:03 especially over the rest of this year
08:05 as we go into the middle of Q3?
08:07 - So data drives milestones and data drives partnerships.
08:12 And milestones and partnerships in biotech
08:14 drive value and drive opportunity.
08:17 So if you look back at our history,
08:19 we're very communicative.
08:21 We're a very highly followed company.
08:25 And we're now setting up to be able to get the interest
08:28 of large companies that need new drugs in their pipeline
08:32 for an unmet medical need.
08:34 And we'll try to position ourself for that group
08:37 of capital sources from a partnership perspective
08:40 that can really drive value.
08:41 So we've built the infrastructure.
08:43 We've built it sanely and frugally.
08:46 And now I think over the next two or three years,
08:48 and perhaps even sooner in terms of milestones,
08:51 we'll be able to capture that value.
08:54 - Wonderful.
08:54 Dr. Hedrick, we know you're busy.
08:56 It's your conference out in San Francisco.
08:57 Congratulations on the data coming out.
08:59 And thank you very much for taking a few minutes out
09:01 to spend with us here this morning and share more details.
09:04 - Yeah, Michael, thanks.
09:05 See you. Take care.
09:05 Have a good weekend.
09:06 [music]

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