Plus Therapeutics, Inc.
Q1 2021 Earnings Call Transcript

Published: 23 Apr 2021

[Operator:]

Good afternoon, ladies and gentlemen. Welcome to the Plus Therapeutics First Quarter 2021 Results Call. At this time, all participants have been placed in a listen-only mode, and the floor will be opened for your questions following the presentation. Before we begin, we would like 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 risk and uncertainties, including the risk and uncertainties described under the Risk Factors section included in Plus Therapeutics' annual reports on Form 10-K and quarterly reports on Form 10-Q filed with the Securities and Exchange Commission from time to time.

[Marc Hedrick:]

Good afternoon, ladies and gentlemen. Welcome to the Plus Therapeutics Fourth Quarter and Full year 2020 Results Call. At this time, all participants have been placed in a listen-only mode, and the floor will be opened for your questions following the presentation. Before we begin, we would like 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 risk and uncertainties, including the risk and uncertainties described under the Risk Factors section included in Plus Therapeutics' annual reports 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 floor over to Dr. Marc Hedrick, Plus Therapeutics' President and Chief Executive Officer. Sir, you may begin.

[Marc Hedrick:]

Great. Thank you, Catherine. Good afternoon, everyone and thank you for taking the time to join us today as we provide an overview of recent business highlights and discuss our 2021 first quarter results. Joining me on the call today is Mr. Andrew Sims, our Chief Financial Officer. Before Andrew provides a summary of our financial performance, I would like to provide an update on the company's business activities since our last earnings call. For those of you new to the company Plus develops complex, innovative therapeutics for rare and difficult to treat cancers such as cancers of the central nervous system. Our aspiration from a drug development perspective is to leverage our expertise in drug formulation, nanoparticles drug design, drug manufacturing and scale up and expertise and novel delivery technologies to provide better tumor targeting and killing a greater safety profile and ultimately better clinical outcomes.

[Andrew Sims:]

Thank you, Mark and good afternoon, everyone. Please refer to our press release issued earlier today for a summary of our financial results for the first quarter ended March 31, 2021. As of March 31, 2021, cash and cash equivalents were $14.4 million compared to $8.3 million as of December 31, 2020. Cash used in operations for the first quarter 2021 was approximately $3 million compared to $1.5 million in 2020. This difference is mainly due to timing differences on certain accounts payable and accrued expenses were paid in 2020 and in particular related to BARDA and professional fees. Revenues in the first quarter of 2021 as compared to approximately $118,000 in the same period last year. This decrease was due to the close out of the BARDA contract as previously disclosed. Research and development expenses were $1.1 million for the first quarter 2021 as compared to $0.9 million for 2020. The increase was primarily due to the additional RNL development costs. G&A expense was $1.12 million for the first quarter of 2021 as compared to $1.6 million for 2020. The decrease was primarily driven by a reduction in professional fees and recruiting expenses.

[Marc Hedrick:]

So let me just summarize the forthcoming milestones and then we'll move to Q&A. So we intend to complete enrollment of the respect phase 1 study in the current glioblastoma as soon as we get through recommended phase 2 dose and then proceed with the trial. We plan to complete the pivotal trial planning with the FDA in parallel for RNL for recurring glioblastoma and then complete the key CMC activities as I mentioned before. We plan to complete the PID meetings as mentioned with the FDA, execute any IND enabling studies and move into clinical trials for our RNL indications leptomeningeal cancer in pediatric brain cancer. We also plan to continue develop and evaluate additional external and internal drug development candidates to RNL, DocePLUS and generic DoxoPLUS. And with that, those are prepared remarks. I'll turn it back over to you Catherine for Q&A.

[Operator:]

And your first question is coming from Xiomi .with Raymond

[Unidentified Analyst:]

My first question is on the Respect study, so you mentioned that the FDI has decided to do a Cohort Six instead of going to Cohort Seven, so should we take that the doses used in court six was likely going to be the ones used in the next phase.

[Marc Hedrick:]

Shaun it could be. I presented what I through were the most likely outcomes in the script and so where we did not see dose limiting toxicity in the six cohort and typically that would be the reason to stop there and take that dose forward, but we're using the phase 1 not only get the recommended phase 2 dose but also to ensure that we go into the next trial with the appropriate delivery parameters and so I think we're maybe getting a little bit greedy here but we're delivering so much radiation that we can essentially how many times can you kill the same cancer cell. So part of what we're trying to do is to get that microscopic disease that's not enhancing on the scans and then and we do that effectively by increasing the flow rate which is increasing the pressure and pushing that the leading edge of the radiation into that microscopic disease.

[Unidentified Analyst:]

Got itm when you think you'll be able to get the next update of Cohort Six?

[Marc Hedrick:]

We actually the in Texas at the end of February because all three of our sites in Texas actually into February and March light months. So things are covered in April and a lot of patients in screening as I mentioned we've got, we've treated two out of the three patients. So I think we remain maybe the next earnings call or if we make a decision prior to that we may just put that that news out at that time. So either before or likely the next earnings call.

[Unidentified Analyst:]

Our next question is on the CMC side, so with what should we expect the timeline on that? Then when do you expect to have the ready drug for the like for example pivotal study?

[Marc Hedrick:]

We're on track on from a timeline perspective. So we said we're want to have a drug ready for registration trial by around the end of 2021 and so we're on track to do that phase 2 drug supply which we contemplate expansion cohort with Phase 1. That we'll be ready for that as well, but that's a different supply chain if you will for that. So we're on track for both of those with the end of 2021 early 2022 is the timeline to have that drug available.

[Unidentified Analyst:]

I see. My last question is on the next initial clinic study. So what are your thoughts on the designs about the study? Would you be looking to go at it with a traditional randomized -- randomized phase 3 or adapt phase 2, 3 with an adaptive design or would look participating for the other studies that are going on .

[Marc Hedrick:]

Yeah, so it's a looks to me – it's actually in terms of the phase 1,2, that trial is fairly locked in at 55 patients estimated 21 to get to the maximum tolerated dose in – upto another 34 patients at the recommended phase 2, so that's fairly well locked in and see me as likely to make many changes in terms of phase 3 and I think what I could say is we're likely to look at overall survival as a primary point. The number of patients is going to be based on what we see in the combination of the phase 1, phase 2 at the recommended phase 2 dose. I anticipate one uses synthetic control arm, in that will also be patients that are very likely that had no more than one occurrence in their -- patients as you know that those two were poorly and they don’t contact very we'll, so I don't see it's kind of randomizing 1 to 1 against PRC as using potentially a synthetic control arm or more participating in an agile control.

[Unidentified Analyst:]

I see, thanks for the additional color on that I have.

[Marc Hedrick:]

Thank you Sean.

[Operator:]

Your next questions comes from the line of Edward Woo with Ascendiant Capital.

[Edward Woo:]

Thank you for taking my questions. I had a question more on the three sites that you have running I know you mentioned that those of the and the delayed -- but is everything back on track? Any Covid issues and also have you thought about potentially expanding the sites?

[Marc Hedrick:]

Hey Ed, yeah it was really just maybe 4 or 5 -- we typically screen patients every week, so just patients can travel all of our sites till Texas. Texas got it really bad so we are back to normal we are screening multiple patients. We now, so things are going well with a lot of work to get the world out of after trial -- that's helping us, somewhere looking at some of the ways to do that and into your point about trial expansion, so yes, we absolutely are talking to additional sites probably not that thinking as much about the phase 1 as is an expansion cohort at the recommended phase 2 dose so that when net decisions made will be ready to get the sites on board and trained in the sites open label going to registration trials so when we get there used connection enhanced delivery there that we know through the high-volume sites are and will be going to the sites early on in that process to be we have launched them already.

[Edward Woo:]

Great and then you mentioned at phase 2 it's no indication that you have – to file an IND?

[Marc Hedrick:]

Edward, you are

[Edward Woo:]

Sorry, can you hear me now?

[Marc Hedrick:]

Yeah, that maybe if Edward maybe can call back in a jump back in the be great, may be if somebody else in the queue, we could get him?

[Operator:]

And there are no further questions at this time. I would like to turn the call back to you Dr. Hedrick for the additional and closing remarks.

[Marc Hedrick:]

Okay great thank you Captain, sorry about the -- just want to thank everyone who joined us on the call and also in participating in the call and also just like to say thank you to our employees, who work so hard and so dedicated to try to find a solution for the -- and other rare cancers and then also like to specifically thank the patients and the doctors and hospital staff, who we spend a lot of time with, and they a helpfully support and make a clinical trial -- So thanks again and please have a good evening.

[Operator:]

Thank you, this concludes today's conference call