Good afternoon, ladies and gentlemen. Welcome to the Plus Therapeutics First Quarter 2020 Earnings Results Call. At this time, all participants have been placed in a listen-only mode, and the floor will be open for questions following the presentation. [Operator Instructions]. 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 in the Risk Factors section, included in the Plus Therapeutics’ annual results on Form 10-K and quarterly reports 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 or circumstances after the date they are made. It is now my pleasure to turn the call over to Dr. Marc Hedrick, Plus Therapeutics’ President and Chief Executive Officer. Sir, you may begin.

Good afternoon. Thank you, Christina. And welcome to our Q1 fiscal year 2020 earnings call. As Christina said I’m Marc Hedrick, President and CEO of Plus Therapeutics. And joining me is our Chief Financial Officer, Mr. Andrew Sims. Once again, on behalf of all of us on the Plus Therapeutics team, we are hoping that you and your families are maintaining the best possible health as this pandemic drags on. Today I am very pleased to report results from the first quarter of fiscal year 2020. Before I get to our Q1 update and results, I would like to update you on the COVID-19 situation as it applies to Plus. Our 2019 strategic decision to implement a substantially virtual operating model is serving us well during the pandemic. Our facilities in Austin and San Antonio have remained open, but lightly staffed with flexible work schedules to provide maximum support for our employees. Coincident with Texas Governor Abbott's executive order effective on April 30, 2020 Plus has implemented a Phase 1 reopening plan intended to put the company on a trajectory to return the business to full operational mode as soon as possible. All federal and state recommended steps intended to protect the health of employees while moving towards full operational mode have been implemented. Over the past two to three months no significant supply chain interruptions have occurred, and we remain in close coordination with our partners, vendors to ensure the situation does not change. At this point, none of our employees have tested positive and we currently expect no material impact on results for fiscal year 2020 which ends December 31, 2020. We continue to screen patients for our ongoing clinical trial and we are starting to see some shifts away from COVID precautions to more routine hospital operations.…

Thank you, Marc, and good afternoon, everyone. I'll be discussing Plus Therapeutics’ financial results for the first quarter of 2020 as presented in our earnings released today. Our Q1 2020 operating cash burn was approximately $1.5 million compared to $3.3 million in Q1 2019. The reduction in annual cash was mostly related to discontinued operations, which resulted from reductions in operating expenses. The net loss for Q1 2020 was $1.1 million as compared to a net loss of $3.2 million in Q1 2019. The decrease in net loss is mainly related to discontinued operations of $0.7 million and the change in fair value of the warrants of $1.7 million. The research and development expenses in Q1 2020 or R&D expenses was $0.9 million versus a $1.4 million expense in Q1 2019. The decrease in R&D year-over-year spending was primarily attributed to a decrease in spend as a result of discontinued manufacturing subsequent to the sale of the company's former Cell Therapy business. R&D expenses will increase in 2020 as investments are made into the development of RNL. Now on to our sales and marketing. Our sales and marketing expenses remain consistent on a quarterly basis at approximately $0.1 million. G&A expense was $1.5 million this quarter as compared to $1.4 million in Q1 2019. The Q1 2020 increase was primarily driven by increased professional fees which was offset by a reduction in personnel expenses when compared with the same period in 2019. Now with respect to revenues, Q1 2020 total revenues were $0.1 million as compared to $0.7 million in Q1 2019. Decrease in revenues is mainly due to the closeout of the government contract with BARDA. Turning to the balance sheet. As of March 31, 2020, we had $16.1 million of cash and $9.3 million of debt principal. Subsequent…

Thanks, Andrew. Let me finish up before Q&A and discuss progress on our stated 2020 milestones. Thus far in 2020, as guided, we have announced and closed our in-licensing transaction for RNL and executed a complete restructure of our term loan as Andrew mentioned. Going forward through the remainder of the year, we intend to optimize the regulatory and clinical program for RNL for glioblastoma and obtain FDA feedback on next steps. Two, we tend to substantially upgrade the supply chain for RNL as well as the manufacturing controls and scalability of the product or late-stage clinical trial standards. Three, we intend to expand the Phase 1 trial from one to three sites. Four, we hope the complete enrollment of the dose finding study for RNL, assuming the COVID-19 impact does not increase and report that data and work to publish that data in a publication subsequently. Five, we intend to work with the agency to develop a Phase 2 pivotal study plan for glioblastoma. Six, we intend to complete our internal review of additional indications for RNL and execute any required IND-enabled [indiscernible] clinical introduction. Seven, we will continue to be aggressive but highly disciplined in assessing new pipeline enhancement opportunities for the company. And finally, we'll continue partnering discussions with the goals of finding strategic development partners for our clinical programs, RNL DocePLUS and DoxoPLUS. With that, I'll turn it over to the operator, Christina, for any questions that might be in the queue.

The floor is now open for questions. [Operator Instructions] Thank you. And our first question is coming from Anita Dushyanth with Zacks Investment.

Just had a couple of questions regarding the Phase 1 trial. So regarding the cohorts, I know you mentioned you're enrolling currently cohort 5. Could you reiterate sort of how many subjects there are totally in this enrollment and how many per cohort?

So yes, it’s a standard dose escalation, dose finding study protocol where we did three cohort, assessed safety, and then moved to the next cohort. So thus far, we've enrolled 13 patients. And we're -- we treated first patient in the fifth cohort. And in each cohort, their escalation is not only in dose in terms of [indiscernible], but also in terms of volume because tumors have different volumes. We are escalating dose [indiscernible]. My guess is that they'll be somewhere between six to eight patients before we finish the trial. The trial has been enrolling relatively slowly because there's been one site. So one thing we hope we can do as the new sponsor has come in and help facilitate getting UT Southwestern and MD Anderson up to speed quickly. We made progress even in the interim prior to closing and that will add two new sites that are enthusiastic about contributing patients to the trial.

And as a follow-up to that, I was wondering, as far as the Phase 2 is concerned, like are you looking at the response rate and the survival as an outcome and what would the timeframe be for that?

So currently in the NCI-approved grant and the clinical trial, it would be a survival. And it’s one -- one of the things that we're looking at if we were with the [PRS], with the trial is to look at ways that we might be able to accelerate that trial and maybe look at surrogate endpoint, potentially effective response rate and an expedited path to the clinic. So, right now I think it's premature before we talk to the agency about ways to optimize a clinical strategy to talk about at this point.

And I know you indicated that this is clearly addressing an unmet need. Are you in conversation with the FDA regarding applying for a fast track or orphan designation?

So have we disclosed the transaction last week? The answer is, no, we haven't been really authorized to communicate with the agency yet. So that’s high on our priority there. We think there's some opportunities there around orphan designation, accelerated approval, and fast track for potentially breakthrough assuming the data support that. So that's high on our priority list to explore. As soon as we get a meaningful feedback from the agency, we'll make that public.

Okay. And just one last thing from me, what other possible indications are you looking at where the RNL has potential? I think you mentioned head and neck cancer -- or just correct me if I'm wrong?

Yes, so that's a great question and, it's a hard question to answer without a lengthy response. And so, there are a number of published papers that I'm happy to share with you offline and make available fully to you. But the things that I'm most excited about are over current head and neck cancer. And the reason why is those tend to recur locally. I’m a plastic and reconstructive surgeon. I’ve reconstructed a number of these patients that have very disfiguring lesions, have maxed out on radiation therapy and they really have nowhere to go once they recur, typically around the side of the original tumors or suture line. So it would be much simpler even for glioblastoma to identify the tumor and inject the RNL compound directly into the tumor to get coverage of the tumor to essentially do the inside-out radiotherapy at the tumor. So that's something I think that's very promising potentially. The other thing that I'm interested in is sort of a variant of the same theme. It's one, leptomeningeal carcinoma. Leptomeningeal is increasing in number. There are perhaps a hundred thousand plus patients in the U.S. to get carcinomatosis in the leptomeninges and then really no good treatments for it. Although the primary treatments are getting better that once that complication occurs, there are really no good treatments. There was one drug that was on the market called DepoCyt that was recently removed over the summer. It's no longer available. So I think that's a real opportunity in that. The Part B is peritoneal carcinomatosis, which is a complication of a number of other gastrointestinal cancers, in particular ovarian cancer, which often presents very late in the course because it's typically in the early stages. And there've been no really good treatments for treating those intra-peritoneal metastases. So I think in this -- and there’s preclinical data on everything, and I’m bringing up with you. So they're encouraging preclinical signals and I think the next step for us is to figure out within this group that I just mentioned and a group of other indications that we're also looking at which are the most promising, which makes the most sense to pursue and then figure out what's required from an IND-enabling perspective to get those into the clinic.

And your next question comes from the line of Ed Woo with Ascendiant Capital.

Touching back on the prior question in terms of the number of indications, do you believe that you'll just be focusing on one other indication? Or do you believe that maybe you'll be focusing on multiple indications at the same time?

Yes, hey, Ed. It’s Marc. Good question. I think it's partly related to the availability of capital. I anticipate looking at least one other indication, and determining what's required with the agency to move that into the clinic, and then that will depend on some capital availability. One strategic reason we moved the company to Texas is to have availability of the CPRIT related funding. As I mentioned, this RNL technology, it's previously received an award through CPRIT. It doesn't have current funding, it's funded through the NCI, but I think there are opportunities with CPRIT to fund additional indications and our hope is to leverage that as well as other non-dilutive sources to do that. But I think I would anticipate us being cautious and cash is important now in the current environment. So I think we'll take a very cautious approach but we'll make that clear in terms of our inclinations once we’ve completed our analysis.

And then on RNL you mentioned that you have funding through Phase 2 through the National Cancer Institute. Is that correct?

Yes.

That sounds great. Have you got the funding already or is it kind of a work in process where you do the development and then you kind of get reimbursed back? Or how does that work?

Yes, so there's -- the funding is awarded -- but maybe back up a sec. So one of the things that attracted us to this indication was not only how innovative it was, and how potentially game changing it could be through a number of really pesky oncologic problems. But it had -- it just received when we got to know the company, it just received NCI funding through Phase 2. So that's predicated on a trial and clinical approach, where there's not a corporation involved. So our plan is to build off that NCI funding and do what we can do to accelerate enrollment and bring the supply chain and CMC as to what we think are commercial standards of scalability and controls and so forth. And that's going to require some capital. So that's not dialed into the roughly $4 million that the NCI has awarded. Now in terms of the cadence of the awards, generally, as you know, with those types of grants, they tend to occur over time and they're granted yearly. So that this grant pays out over a number of years and it pays through Phase 2. But this is actually the first year of the award. So yes, that award has been issued.

Great, and then moving back to DoxoPLUS and DocePLUS. Has there been any status in terms of looking for partnerships on those drugs?

Yes, nothing to report. I think as I mentioned in my prepared remarks, at this point, given our excitement and the innovative nature of the RNL programs, as we force rank our internal opportunities -- and it’s been increased greatly since we added this asset. I think it makes sense to focus on partnering. And thus far there's interest but we haven't seen the right deal and the right partner. So we'll continue to do invest some time and effort into finding the right partner. But we won't invest any specific dollars in further developing those programs. Those will go entirely to the RNL program.

[Operator Instructions]. You do have a question for the line of [Jim Fitzpatrick with Oasis].

So if I look at your cash position and reducing your burn, you're in a pretty good position for the foreseeable future. Is that correct?

Hey, Jim, thanks for the question. I would say we're in a much better position than the company's been in quite a while. So yes, we're in a good position as it relates to the RNL asset, particularly given the fact that it comes sort of prefunded, if you will.

Right. And then do you see your burn and cash position changing in the future? Or is that a pretty good run rate for the foreseeable future?

I'm going invite our CFO Andrew Sims to answer that more specifically. Andrew, do you mind?

Sure. Thanks, Marc. Jim, as per the 10-Q we just released, we finished Q1 with just over $16 million of cash. As I mentioned, we restructured the Oxford facility and made a principal payment of $5 million in early April -- April 1. Depending on the requirements for RNL development, we have approximately 12 to 18 months cash balance without raising additional capital, that range is driven by the speed of enrollment and development of RNL. So the plan is to be as aggressive and efficient in the use of cash as possible, but at the same time making rapid progress in the development of that asset. In addition, we will utilize non-dilutive sources of capital such as the NIH grant as Marc mentions, CPRIT which he also mentioned and then partnership dollars. The final piece is, the company in the past has leveraged an ATM and equity line and we intend to put one in place later in this year and obviously use it very carefully and if and when it makes sense to do so.

And you have no further questions at this time. I'll now turn the floor back over to Dr. Hedrick for any additional or closing remarks.

Thank you. I think to close, I'd like to just plug a video that's coming on the technology. You may have seen Tuesday's announcement where Dr. Andrew Brenner, who's the development leader of the RNL program, and an academic neuro-oncologist in Texas is scheduled to conduct a live patient focused webinar entitled “A Promising New Radiotherapy For Recurrent Glioblastoma, an Introduction” that will be on this coming Sunday, May 17, 2020 at 7:00 PM Eastern. That is part of the Newsela Foundation Webinar series to be presented live on the foundation's website at virtualtrials.com/webinar/. There is a complete dial in information is in Tuesday's press release, which you can find on our website in the Investors section. There's no charge for the event, although the foundation welcomes donations. We are participating in the presentation as part of our recognition of Mays’ Brain Tumor Awareness Month. So with that I'll just thank everyone again for joining us today. Much more information can be found at our website plustherapeutics.com and on our LinkedIn and Twitter, social media sites. As always, on behalf of the Board and management, thank you for your support of Plus Therapeutics and have a good evening. Bye, bye.

Thank you. This does conclude today's conference call. Please disconnect your lines at this time and have a wonderful day.