Good afternoon, ladies and gentlemen. Welcome to the Plus Therapeutics Second Quarter 2022 Results Call. Before we begin, we want to advise you that over the course of the call and question-and-answer session, forward-looking statements will be made regarding events, trends, business prospects and financial performance, which may affect Plus Therapeutics' future operating results and financial position. All such statements are subject to risks and uncertainties, including the risks and uncertainties described under the Risk Factors section included in the Plus Therapeutics' annual report on Form 10-K and quarterly report on Form 10-Q filed with the Securities and Exchange Commission from time to time. Plus Therapeutics advises you to review these risk factors in considering such statements. Plus Therapeutics assumes no responsibility to update or revise any forward-looking statements to reflect events, trends, circumstances after the date they are made. It is now my pleasure to turn the floor over to Dr. Marc Hendrick Plus Therapeutics' President and Chief Executive Officer. Sir, you may begin.

Thank you, Jonathan. Appreciate it. Good afternoon, everyone. Thank you for once again joining us today as we provide an overview of recent business highlights and discuss our 2022 second quarter financial results. Joining me on the call today is Dr. Norman LaFrance, our Chief Medical Officer; and Andrew Sims, our Chief Financial Officer. I'll begin the call by reviewing our recent corporate and clinical progress before turning the call over to Andrew to review our financials. And Dr. LaFrance will be joining us for a question-and-answer period. I could say with a tremendous amount of certainty that 2022 is shaping up to be an outstanding year of progress for Plus Therapeutics across all fronts. I continue to be very pleased with our team's performance in critical areas such as drug manufacture and clinical development. Also, I'm very excited about the performance of our 186RNL drug in our two active clinical indications, glioblastoma and leptomeningeal metastases. While still in the early- to mid-stage of clinical development, 186RNL is functioning biologically in a manner that is very consistent with its original design objectives and showing a solid safety profile coupled with a biologic response. So let's start with Rhenium-188 NanoLiposome Development Program and specifically our CMC activities. In July 2022, the Company completed the technology transfer and initiation of cGMP manufacturing of the 186RNL drug intermediate with Piramal Pharma Solutions. Additionally, the intermediate drug product in stability testing, and we believe it to be compliant with FDA guidance for manufacture of nanoliposomal drug products for use in late-stage clinical trials and even commercialization. We expect to have GMP drug availability in the second half of 2022 on time for ongoing and planned Phase 2 clinical trials in adults with recurrent glioblastoma leptomeningeal metastases in all future disease targets. In Q2, the…

Thank you, Mark. Good afternoon, everyone. Please refer to our press release issued earlier today for a summary of our financial results for the 2022 second quarter ended June 30, 2022. As of June 30, 2022, cash and cash equivalents were $18.1 million compared to $18.4 million as of December 31, 2021. This represents 18 to 20 months of cash on hand. Cash used in operations for the June 30, 2022, was $6.5 million compared to $5.4 million in the same period for the previous year. The main changes between the second quarter of 2022 and 2021 are as follows: Total operating expenses for the second quarter of 2022 were $5.1 million compared to $2.6 million for the second quarter of 2021. The increase is due primarily to the following: increased one-time development expenditures on CMC-related activities to develop and produce GMP quality RNL drug material. The overall cost of this development program is in line with our original forecast of approximately $5.5 million. Expenditures are scheduled to be completed in late Q3 2022 with only minimal additional stability testing expenses required on a go-forward basis thereafter. $1 million related to a combination of third-party professional services and consulting in preparation for our planned FDA meetings, as Marc mentioned, as a clinical trial planning activities to support the ongoing and future glioblastoma development program. The expenditures will be completed as planned in Q3 2022. And, to a lesser extent, an increase in legal, IP and other general corporate expenses. Interest expense decreased from $229,000 in the second quarter of 2021 to $181,000 in the second quarter of 2022. This decrease reflects the continued principal pay down that commenced in November 2021 on the Company's Oxford debt. Net loss for the second quarter of 2022 was $5.3 million or $0.24 per share compared to a net loss of $2.8 million or $0.25 per share for the second quarter of 2021. Now, I'll turn it back to you, Mark.

Great. Thank you, Andrew. Before we move on to Q&A, let me just summarize key milestones anticipated for the remainder of 2022. So besides, of course, continuing to work to meet our clinical enrollment goals, we intend to present ReSPECT-LM Cohort 1 data at the Society of Neuro-Oncology Brain Mets meeting, August 12 to 13 in Toronto. We also intend to present the ReSPECT-GBM Phase 1 data at the European Society of Medical Oncology in September in Paris. We intend to report on our two planned FDA meeting minutes in Q3, one for CMC and one for the ReSPECT-GBM ongoing clinical program. We anticipate achievement of our GMP 186RNL manufacturing capability goal soon, and we'll make that public. We also will communicate our planning process in an ongoing manner and the beginning of execution of Phase 2 activities for ReSPECT-GBM. We intend to submit, as mentioned, a protocol for respect pediatric brain cancer, the ReSPECT-PBC trial later in the year, we'll announce that. And then finally, we'll announce a 188 BAM pre-IND submission for planned clinical introduction in liver cancer, and that will be right around the end of the year. So at this point, Jonathan, let me turn it back over to you, and we'll take some Q&A.

[Operator Instructions] And our first question comes from the line of McCarthy from Maxim Group. Your question please.

Hey, guys. Thank you for taking the question. It's Michael Rabinowitz on the line for Jason. I'd like to see if you could provide a bit more on the mechanism behind the BAM program and how it behaves differently in the body to enable that targeted use in solid organ cancers.

Michael, yes. So right now, the data we have is preclinical only. And -- but the idea is that unlike the two products on the market that are permanent glass or polymeric that are used for radioembolization, this product would be bioresorbable. And so, we're still in the process of defining the curve that -- and timing of that bioresorbability. But as I mentioned, the idea is that you would identify the tumor, you would embolize the area around the tumor to incorporate the tumor in the radiation delivery area. And then after -- sometime after the radiation has been fully delivered and there's been full decay then the body will resorb that and reestablish perfusion, which they would potentially allow you to come back and retreat, if you needed to or there was further recurrence. So, that's sort of the general idea. Does that answer your question?

I believe he dropped off and then joined -- rejoined the call. So…

Okay. No worries. You notify me.

And our next question comes from the line of Ed Woo from Ascendiant Capital. Your question please.

Yes. For the Cohort 1 of the ReSPECT-LM trial, how many patients was that? And do you -- and did the enrollment go according to plan? And what do you think would be the challenges to do Cohorts number 2?

Hey, Ed, thank you. It did. To take a step back, the FDA has asked us to have a three-month period between the first patient and 1 Cohort 3 month and the first patient in the next cohort. So we sort of have this mandatory weight. We also have a 30-minute -- excuse me, a 30-day delay between the first patient in the new cohort and the second patient, but we can do two and three relatively quickly. So in best case, we could get the first nine patients enrolled around the end of the year, and that's kind of going at the maximum rate depending on kind of following that dictated schedule. And then the trial design incorporates at that point, and this was a great suggestion by the FDA to come back to the FDA, and then we will amend -- based on the safety data, we'll amend the data collection and provide the opportunity for retreatment to these patients. So potentially, we could come back and start providing additional treatments as we get increasingly more comfortable with the safety profile. So the idea is, again, just we'll try to get the first nine patients enrolled quickly, assuming there are no safety issues, of course. And that's kind of around the end of the year. And then we'll go to the FDA, there'll be a pause while we interact with the FDA, and then we plan to come back with quite a bit number of sites. There's a lot of interest in the trial. And then, we'll move to, hopefully, additional doses in each patient in an expanded treatment profile.

Great. And then the next question is, you obviously had a lot of interactions with the FDA and you're looking forward to putting out the notes that you guys have. What has been a timetable with interacting with the FDA? Have things pretty much gone back to normal post COVID? Or are you still seeing possible delays here and there?

Yes. So most of our interaction with the FDA that has been more recent. And to answer your question -- it's both to myself and to our Chief Medical Officer and our regulatory consultants. So, I think we've been very happy with the turnaround and the interaction. It's been great. It seems totally normal.

[Operator Instructions] We have a follow-up from Jason McCarthy from Maxim Group. One moment.

Sorry about that. I got some bumped off the call before. But I'd like to see if you could discuss a bit further with the collaboration with Biocept does for your clinical trial in LM. How do regulators view the use of inside to guide treatment? And can this be used as a surrogate endpoint for response monitoring? Is it more targeted at just collecting additional data to support your development?

Yes. It's -- so the ultimate use of this is yet to be determined. We do think there's an opportunity to potentially use it as a surrogate endpoint. In fact, I'm sure it will be. Now whether it ultimately becomes a primary endpoint or secondary endpoint or something else, it remains to be seen. We'll see what the data shows. So I think that would be Biocept. It would be a meaningful follow-up endpoint in these patients. I can -- so the way I look at it is that this is -- this is an interesting disease because all of these patients have Ommaya reservoirs in them that we use both therapeutically. And as I mentioned, I think the current treatment it's typically important in these patients. So patients come back twice a week and have chemotherapy injected into the port. Well, there's also the opportunity at any point in time to withdraw CSF and measure certain things. The -- what we've done thus far with Biocept is simply measured tumor cells per mL and report that. And I didn't mention this. You'll see the full data set in August. But in all three patients we've treated, we've seen dramatic reductions in tumor cells that are persistent out a month with a single administration. So, this tumor cell data is looking like it's providing information that supports biologic activity of the radio therapeutic in the CSF. We're also looking at other tumor cell markers more an exploratory phase and also intend to look at markers of radiation-related damage and do that again as exploratory phase with Biocept. They have a much greater capability beyond just the physical accounting of tumor cells. So, we think it's -- I think it has a lot of potential utility and potentially even guiding therapy. I mean one could imagine that patient gets treated, you follow their certain markers, including tumor cell count over a period of time and you make your redosing decisions based on the data you find from repeated or serial CSF sampling.

All right. And then just one last one for me. I'd like to just ask if there are any unique challenges associated with the treatment of LM compared to something like glioblastoma?

Yes. So, I would say on the downside relative to GBM, these patients can be very fragile. And so we've had a couple of patients who -- we had -- we were on track to treat in a decompensated because their survivals are very low, even with treatment, low. So -- but from the time they've had their Ommaya reservoir placed, they've had their -- we do a flow study just to make sure there's good flow from the ventricle to the rest of the CSF space. The patients have decompensated and they no longer match the inclusion/exclusion criteria. So for us, the key there is simply to make sure that we compress the time down. And then also, we make sure that we ideally have more patients than we have drugs so that we don't slow down the enrollment of the trial. You didn't ask about this, but on the flip side, I'll just follow into here that these are much easier patients to enroll in the sense that physicians are very interested in this trial. There's a lot of interest in participating. The physicians see that we talk to see multiple patients a week that would qualify. I think this trial could enroll very quickly once we get in a more mature phase of the development plan, and there's a lot of physician interest in this drug.

[Operator Instructions] And this does conclude the question-and-answer session of today's program. I'd like to hand the program back to Dr. Marc Hendrick for any further remarks.

Thank you, Jonathan. Just to close, I want to thank everybody that joined us on the call today and provide my appreciation also to stockholders, employees, physicians and consultants with whom we work and the patients who trust us. So as always, we'll work to provide full and frequent updates as we move forward with these various programs. Thank you once again.

Thank you, ladies and gentlemen, for your participation in today's conference. This does conclude the program. You may now disconnect. Good day.