Plus Therapeutics, Inc. (PSTV) on Q2 2021 Results - Earnings Call Transcript
Operator: Good afternoon, ladies and gentlemen. Welcome to the Plus Therapeutics Second Quarter 2021 Results Call. At this time, all participants have been placed in a listen-only mode, and floor will be open for your questions following the presentation. Before we begin, we want to advice 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 and including the risks 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. Marc Hedrick: Great. Thank you very much, Catherine. Good afternoon, everyone, and thank you once again for taking the time to join us today as we provide an overview of recent business highlights and discuss our 2021 second quarter financial results. Joining me on the call today is Mr. Andrew Sims, our Chief Financial Officer. But 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 call. Last quarter, I provided a detailed overview of the company and I'll refer you back to that description. But in summary, for those new to the company, Plus Therapeutics is a clinical-stage pharmaceutical company developing innovative, targeted radio therapeutics for rare and difficult-to-treat cancers. Our lead drug is, RNL, Rhenium NanoLiposome. This is a proprietary liposomal encapsulated radionuclide that is delivered local regionally via targeted 3-dimensional convection-enhanced delivery directly to the tumor. The active agent is rhenium-186 isotope, which is a dual energy emitter releasing both cancer-killing beta particles, which are high-energy electrons and gamma particles, which are useful for imaging and dosimetry. Rhenium is a unique isotope, in part, because of its energy profile. Its beta energy has a short path link, which gives one precision, allow dose rate which provides a margin of safety and a high energy density, which is particularly toxic for highly mitotic cells, which can overwhelm the DNA repair mechanism that can also contribute to radio resistance. Thus far, we've shown that we can successfully deliver 20 times the radiation dose one the radiation dose one can deliver with traditional external beam irradiation. Our initial indication for RNL is recurrent glioblastoma, which affects approximately 12,000 to 13,000 patients annually in the U.S. and about the same number of patients in the EU. It is the most common and lethal form of brain cancer and the treatment of this devastating disease remains a significant medical challenge. Published studies indicate that external beam radiation provides the best incremental improvement in survival of all therapies currently used for glioblastoma, and it remains an essential component of multimodal therapy for both glioblastoma and, in fact, many other cancers. In theory, glioblastoma and, frankly, any tumor can be fundamentally controlled if a sufficient dose of radiation can be delivered to a particular tumor. RNL is currently under evaluation in the U.S. ReSPECT GBM trial, which is a dual Phase I and II multicenter sequential cohort, open label volume and dose escalation study of the safety, tolerability and distribution of 186 RNL. The trial is currently funded to a significant degree of a U.S. National Cancer Institute. Andrew Sims: Thank you, Marc, and good afternoon, everyone. Please refer to our press release issued earlier today for a summary of our financial results for the second quarter ended June 30, 2021. As of June 30, 2021, cash and cash equivalents were $17.2 million compared to $8.3 million as of December 31, 2020. Cash used in operations for the 6 months of 2021 was approximately $5.4 million compared to $2.9 million in 2020. This difference is mainly due to timing differences and when certain accounts payable and accrued expenses were paid in 2020, in particular, relating to the legacy government contract together with increased R&D spend. There were no revenues in the 6 months of 2021 as compared to approximately 303,000 in the same period last year. This decrease was due to the closeout of the legacy government contract as previously disclosed. Research and development expenses were $2.2 million for the first 6 months of 2021 as compared to $1.3 million for 2020. The increase was anticipated and reflects additional RNL CMC development costs to obtain cGMP drug product. G&A expense was $2.8 million for the first 6 months of 2021 and as compared to $3 million for 2020. The decrease was primarily driven by a reduction due to tight management of professional and other fees. Interest expense decreased for the 6 months of 2021 and to approximately $476,000 from approximately $601,000 for the same period in 2020, reflecting the paydown of debt principal to $4.3 million in 2020. Net loss for the 6 months to June 2021 was $5.5 million as compared to a net loss of $2.9 million for the equivalent period in 2020. The net loss was consistent year-on-year when excluding the book gains on the warrants reported in the first quarter of 2020. We -- As noted in our quarterly filing, this required transaction was eliminated in the second quarter of 2020 when the Series E warrants were amended. And now I'll turn it back to you, Marc. Marc Hedrick: Great, Andrew. Thanks a lot. So before we go into Q&A, let me just summarize the milestones we anticipate over the next few quarters. First of all, with respect to the ReSPECT GBM trial, we intend to complete the current cohorts and present a comprehensive trial update in Q4 of this year. And it's our intention to alert folks for the timing of that as soon as we are able. Also, at that time, we intend to provide an update on next steps and the clinical development of RNL for GBM based on the evolving data set. Upon completion of the current trial and data analysis, and in that Phase I and II meeting with the FDA is likely to help finalize the pivotal trial plan. Operator: Thank you. Our first question is coming from Jason McCarthy with Maxim Group. Please go ahead. Unidentified Analyst: It’s Dave on the line for Jason. Just out of curiosity here, are you currently or do you intend on holding any meetings with X-US regulators to discuss past potential approval outside of the US or do you plan on initiating any clinical trials and any X-US territories? Marc Hedrick: I appreciate the question. Right now we don't, it doesn't mean that won't change. I think we want to really stick to U.S. approval and our CMC activities, over the course of the remainder of the year. I think after we get to 2021 and the pivotal plan starts coming together, then we will kind of begin exploring in earnest potentially broadening that trial to include international sites or separate clinical trials. Unidentified Analyst: Okay. That makes sense. And then earlier in the call, you mentioned that, with respect to the patient population that was being evaluated in the ReSPECT trail. You mentioned that patients who had previously received bevacizumab, conducted the bev-naive patients. So, am I correct and saying that you guys are now currently focusing on GBM patients who are in that bevacizumab and naive, that's the target patient population, basically. Marc Hedrick: Yes, that's true. We excluded them, maybe about 9 months ago, doesn't mean we can't treat them. But, what it means to me is that we likely have to change the delivery parameters, perhaps the volume and the rates, to improve the coverage of the tumor, and that's something we can address downstream. But in terms of, in this to market, as quickly as we can and what we're going to exclude those patients. Unidentified Analyst: Okay. That makes sense. And then you mentioned something about a potential Phase I/II , or either a meeting with the FDA regarding potential Phase I/II trial. Would that be potentially happening in 2021? Marc Hedrick: I guess is that's going to be a 2022 event. I think we're going to have to wait and see what Cohort 8 looks like, and look at the evolving efficacy and safety data, and then make a determination about whether we continue to dose escalate. I think that's probably unlikely, but possible. And right now, we are delivering pretty significant volumes and radiation doses such that theoretically, we think we can create a radiation cloud covering the tumor and the microscopic disease of the sphere of about seven centimeters in diameter. So I think we're getting pretty close to the max. But once kind of we have looked at the data, we see what efficacy looks like, the safety looks like we'll make a determination about whether to escalate or not, or whether to go into the next phase. And as I mentioned, that could include an expansion cohort or moving on to the next trial. Operator: Our next question comes from Sean Lee with H.C. Wainwright. Your line is open. Sean Lee: So my first question is on the current cohort. Like Cohort 8, you mentioned with the up volume and dosing, you can able to place fierce about 7 centimeters. So what percentage of GBM patients do you think that's sufficient to cover? And do you believe that -- do you feel that you had to go to a higher dose cohort later on? Marc Hedrick: Yes. So that's a great question and really gets into the therapeutic strategy of these patients. The -- as you know Sean, it GBM doesn't typically metastasize. It kills patients by local growth. If it's left untreated, it grows like a weed, you can surgically extirpate these tumors, but the problem is about 90% of the recurrences occur within a 2-centimeter RIM around the tumor. So you have microscopic disease that you can't image, but you know instinctively is there, and it's likely going to be the catalyst for recurrence. So our concept is that if we could treat tumors that are roughly around 3 centimeters and cover, call it, a 2-centimeter rim around that, which kind of accounts for a sphere and that's an idealized geometry, these tumors don't often occur as fears. But you can cover about a 2-centimeter RIM around a 3-centimeter tumor. And you can theoretically not only ablate the tumor, which is, I feel pretty confident we can do that reliably, but capture that microscopic disease. In our view, that's where you're really going to see some potential improvements and efficacy. And then that might downstream if patients do recur. For example, we've had patients that have it beyond 30 months. Were they to recur, we could potentially entertainment concept of early retreatment and essentially play whack a mole. And one can sort of think about the art of what's possible here. I mean, in theory, you might be able to turn this into a chronic disease, certainly more chronic than it is today. I mean it's an acute killer. So that's how we looked at it. So yes, you could cover a 207 centimeters, but practically, that just doesn't make any sense. I think the sweet spot is going to be kind of the 3-centimeter tumor with a RIM of 1 to 2 centimeters of grain that's diseased, but has microscopic disease, it's going to be the basis of a recurrence. Sean Lee: In terms of the mixed study, you mentioned you're likely -- you're looking to pursue a Phase II pivotal study. So would you be looking to go something towards a special protocol assessment with the FDA? Would you be pursuing, say, a breakthrough therapy designation? What are your plans on that on the regulatory side? Marc Hedrick: Yes. I think all those are possible and those are in our planning, and it's just going to be kind of based on the data. And I think we'll kind of know more around Q3 or more likely Q4 of this year. And that's assuming that we stay on the same enrollment cadence we've been on and get cohort 8 fully enrolled. And then the other thing is -- and as I mentioned, we have a lot of patients that we've treated relatively recently that are still alive. And so we're a bit more data as it relates to the evolving efficacy signal. Sean Lee: I see. My final question is on the upcoming RM and pediatric brain cancer study. So what's still left to do before you can initiate these studies -- And also, would you wait until you have the new GMP manufactured drug before you initiate the studies? Or would you go with your current stock? Marc Hedrick: Yes. On the latter question, we can go ahead and begin those studies today with our current manufacturing protocol, which is sufficient for a Phase I trial. -- as to timing on those, I would think about those sequentially. LM is the priority. And what's left there really is to finalize the IND, which, as mentioned, is going to be a Q3, maybe a Q4 event and then submitting that. And then it really depends on feedback we receive. We've already got a couple of sites identified a number of others that we are investigating. We've identified the PI and the PI is at a site that we're already working with and should be a relatively straightforward path to kick that trial off, assuming we've come to agreement with the FDA. Regarding pediatric brain cancer, Similarly, we've identified the PI, the lead trial site. We're working with them to develop the protocol, but we're just bandwidth constrained. So that won't go in until after which is likely going to be a filing date maybe towards the end of the year. So we probably won't be able to be too definitive about the start of timing until early next year. Operator: We'll go now to Ed Woo with Ascendiant Capital. Your line is open. Ed Woo: Thank you for providing us the latest update. My question is on funding, mainly you've been able to fund most of your studies so far with various grants. Do you know what the funding plan will be if you do move to a pivotal study? Marc Hedrick: Yes. So I appreciate the question. We're in -- company is in a good cash position today. We're really blessed and fortunate to have the majority of our clinical trial covered by the NCI really picks the pressure off our need to raise capital. The management's philosophy is we like to stay at no less than 24 months of for looking cash and we're pretty close to that right now. We intend to stay there. I think it's just good biotech, hygiene to have appropriate tools in place to allow us to be opportunistic and raise capital when the stars align, and we've done that sparingly and -- but strategically. Our plan is to kind of state about 18 to 24 months of cash build to 24%, a little bit more if we can, and then go out and raise additional capital once we get to a position where we're ready to embark upon a pivotal trial and raise sufficient capital such that we can go all the way to an approvable endpoint with that cash without going back to partner or capital markets. So that's our plan. 24 months of cash as a baseline and raise additional cash when we need it -- when we need to it to a provable endpoint and be opportunistic in the meantime. Ed Woo: I was actually wondering with the NCI fund the pivotal study? And also 1 of the reasons you guys moved to Texas was to get the state of Texas cancer funding. Is there an option for the pivotal study as well? Marc Hedrick: No, I don't think -- the latter is not, the fund up through Phase II, and we've got Phase II covered. The NCI grant covers through -- it's a Phase I/II design, and it covers that. That's up to 55 patients, and we're at 22 now. So there's still some runway there. I think it's possible to get grant funding. But frankly, there's some trade-offs with having grant funding, which you're probably aware. There is a underbear loss of control. So my guess is time is money, and we'll very likely want to fund that trial ourselves for practical reasons. Operator: We'll go now to Emad Samad with Octavian. Your line is open. Emad Samad: Marc, you mentioned toward the end of the update about the BDM licensing activities. I was just wondering, could you give us some guidance on the types of opportunities the companies in search of, and what the strategic goals and approach or vis-a-vis the current pipeline, for instance, what should we be expecting from the company? And how are you guys thinking or focused on that aspect of corporate strategy? Marc Hedrick: Emad, appreciate the question. Obviously, the caveat is with BB is it's nothing is done until it's done. But I can get into the strategy a bit and tell you where our focus is right now. So our deal team is really active on 3 fronts. And what you've seen if you've been following the news over the last maybe quarter or so is that -- we're very active on the CMC front. We're partnering with leading suppliers and providers. And the most important of those we report publicly. So it's a good measure of progress. It's also not too early to think about things like barriers to entry exclusivity in terms of the supply chain interactions and further protections on that supply chain and even reimbursement and ultimate margin. So those are all things that are central to us, and we're making progress along those fronts. So that's kind of point 1. Point 2 is sort of in-licensing. And we are very active in evaluating additional new technology both in an effort to expand the platform. We really like the radio therapeutic space and also the pipeline. And we are really focused on becoming increasingly more targeted. Now we -- as you know, with the RNL for GBM, that's delivered in a very targeted way, but it leverages convection-enhanced delivery and imaging and you need a brain surgery in a way to do that. But we're also really looking beyond into other technologies and leveraging vascular access, either arterial or venous access and potential molecular targeting techniques. So we've got a core expertise in delivery in drug formulation and radio therapeutics and very interested in expanding in the targeted delivery space, and that's something we spent a lot of time evaluating potential opportunities. not to say that we're going to find something that becomes prefunded like RNL did with an NIH grant but one can dream. And then finally, and probably much, much, much lesser amount of time spent. We're still evaluating opportunities to out-license our 2 legacy drugs, which I didn't mention, but there is ongoing interest. But frankly, we're just going to need to see the right economics for that to make sense for us right now. So very active on those 3 levels, and we're going to keep communicating and when something happens, we'll let you know. Operator: We have no further questions at this time. I would like to turn the floor back over to Dr. Hedrick for any additional or closing remarks. Marc Hedrick: Awesome. Thank you, Catherine. So I just want to say thanks to everybody that joined us on the call. And on behalf of the board, I'd like to just take a moment as I do every quarter to say thank you to our employees and our extended team members and now our multitude of academic collaborators with whom we work, and that work so hard, and they're so dedicated to finding solutions for GBM and other really tough narrowly cancers. I'd also like to thank the patients and the doctors and the hospital staff, who we spend a lot of time with, frankly, that significantly contribute to making these clinical trials possible. So thanks again, and please have a good evening. Operator: Thank you. This does conclude today's conference call. Please disconnect your line at this time, and have a wonderful day.
Recent Market Movements Highlight Notable Stock Performances
- Plus Therapeutics, Inc. (NASDAQ:PSTV) saw a 177.57% increase in stock price, likely due to FDA's conditional acceptance of REYOBIQ™.
- Impact BioMedical Inc. (NYSE American:IBO) experienced a 170.06% surge, possibly reflecting investor optimism from its participation in The Microcap Conference 2025.
- SAG Holdings Ltd (NASDAQ:SAG) had a 67.41% rise in stock price following the successful closing of its initial public offering.
In recent market movements, several companies have shown significant price changes, capturing the attention of investors and market analysts alike. Among these, Plus Therapeutics, Inc. (NASDAQ:PSTV), Impact BioMedical Inc. (NYSE American:IBO), Rain Enhancement Technologies Holdco, Inc. (RAINW), Osisko Development Corp. Warrant expiring 5/27/2027 (ODVWZ), and SAG Holdings Ltd (NASDAQ:SAG) stand out due to their notable performance.
Plus Therapeutics, Inc. (NASDAQ:PSTV) experienced a remarkable surge, with its price jumping by 177.57% to $1.4184. This biotechnology firm focuses on developing treatments for cancer and other diseases. The significant price movement could be attributed to the U.S. Food and Drug Administration's conditional acceptance of the proprietary name REYOBIQ™ for its lead drug candidate, as highlighted by the company. This development is a positive step in the clinical investigation for Leptomeningeal Metastases and Recurrent Glioblastoma.
Impact BioMedical Inc. (IBO) also saw a substantial increase, with its stock price rising by 170.06% to $1.4313. The company engages in the discovery and development of specialty biopharmaceuticals and consumer healthcare products. The surge might reflect investor optimism about the company's participation in The Microcap Conference 2025, where CEO Frank D. Heuszel will present. This event is a key gathering for growth-focused companies and investors.
Rain Enhancement Technologies Holdco, Inc. (RAINW) witnessed an 83.03% increase in its stock price to $0.11. Although specific catalysts for this increase are not provided, such movements often result from positive news about technological advancements or successful pilot projects. The company focuses on ionization rainfall generation technology, which could be gaining attention for its innovative approach.
SAG Holdings Ltd (NASDAQ:SAG) experienced a 67.41% increase in its stock price to $1.13. This movement could be related to the successful closing of its initial public offering, raising $7 million through the sale of 875,000 ordinary shares at $8.00 per share. The company distributes automotive and industrial spare parts, and this financial boost may indicate strong growth prospects.
These companies, spanning diverse industries from biotechnology to gold development and automotive spare parts distribution, have shown impressive market performances. Their recent gains could be attributed to a variety of factors, including successful clinical trials, technological advancements, favorable market conditions, strategic partnerships, or financial growth. Investors and analysts will likely keep a close eye on these companies for further developments that could influence their stock prices.
Plus Therapeutics, Inc. (NASDAQ:PSTV) Sees Surge After FDA Orphan Drug Designation
- Plus Therapeutics, Inc. (NASDAQ:PSTV) stock surged by 311.4% following the FDA's Orphan Drug Designation for its lead radiotherapeutic candidate.
- The FDA's designation provides benefits like seven years of market exclusivity, tax credits, and fee exemptions, crucial for addressing the unmet medical need for treating leptomeningeal metastases.
- Despite financial challenges, including a negative price-to-earnings (P/E) ratio of -0.96 and a current ratio of 0.44, the recent FDA designation offers a promising outlook for PSTV's future.
Plus Therapeutics, Inc. (NASDAQ:PSTV) is a clinical-stage pharmaceutical company focused on developing innovative treatments for rare diseases. The company is set to release its quarterly earnings on March 11, 2025, with Wall Street estimating an earnings per share of -$0.51 and projected revenue of approximately $1.19 million. Despite these figures, recent developments have significantly impacted PSTV's stock performance.
On March 6, PSTV's stock price surged by 311.4% following the FDA's Orphan Drug Designation for its lead radiotherapeutic candidate, rhenium (186Re) obisbemeda. This drug targets leptomeningeal metastases in lung cancer patients, a rare and challenging condition. The FDA's designation provides benefits like seven years of market exclusivity, tax credits, and fee exemptions, as highlighted by the FDA.
The Orphan Drug Designation is crucial for Plus Therapeutics as it addresses the unmet medical need for treating leptomeningeal metastases. This condition involves the spread of cancer to the cerebrospinal fluid, posing significant treatment challenges. The designation, along with a previously granted Fast Track designation, marks a significant milestone for the company, as emphasized by Mike Rosol, Ph.D., the Chief Development Officer.
Despite the positive news, PSTV faces financial challenges. The company has a negative price-to-earnings (P/E) ratio of -0.96, indicating a lack of profitability. The price-to-sales ratio is 2.17, suggesting investors pay $2.17 for every dollar of sales. Additionally, the enterprise value to sales ratio is 2.68, providing insight into the company's valuation relative to its revenue.
PSTV's financial metrics also highlight potential liquidity concerns. The current ratio is 0.44, indicating the company may struggle to cover short-term liabilities with its short-term assets. The negative debt-to-equity ratio of -0.66 suggests a unique capital structure or financial strategy. Despite these challenges, the recent FDA designation offers a promising outlook for the company's future.
Plus Therapeutics, Inc. Gears Up for Q1 2024 Earnings Release
- PSTV is set to release its EPS estimate of -$0.25 and expected revenue of approximately $1.69 million for the quarter.
- Previous quarter performance showcased revenue of $1.31 million and a gross profit of $1.13 million.
- Significant improvement in EPS from -$0.84 to an estimated -$0.25, indicating a potential positive financial trajectory.
Plus Therapeutics, Inc. (NASDAQ:PSTV), a clinical-stage pharmaceutical company, is gearing up to share its quarterly earnings on Thursday, May 16, 2024, after the market closes. Specializing in the development of targeted radiotherapeutics for central nervous system cancers, PSTV's financial performance is closely watched by investors and analysts alike. The anticipation builds around the earnings per share (EPS) forecasted at -$0.25 and expected revenue of approximately $1.69 million for the quarter.
The upcoming earnings report follows a period where PSTV reported revenue of $1.31 million with a gross profit of $1.13 million. This financial snapshot indicates a company that, despite its challenges, is managing to generate revenue and maintain a certain level of gross profit. The cost of revenue standing at $182,000 for the same period further highlights the company's ability to control its production or service delivery costs, an essential factor for its financial health.
However, PSTV's financial journey is not without its hurdles. The company faced a significant net income loss of -$3.81 million and an operating income loss of -$3.86 million. These figures point to the challenges PSTV encounters in balancing its operational costs against its revenue. The reported EBITDA (Earnings Before Interest, Taxes, Depreciation, and Amortization) of -$3.68 million further underscores the financial strains the company is experiencing, reflecting broader operational challenges beyond mere net income figures.
Moreover, the earnings per share (EPS) for the quarter was reported at -$0.84, a critical metric for investors as it provides a direct insight into the company's profitability on a per-share basis. This figure is particularly significant when compared to the upcoming earnings forecast, which estimates the EPS to be -$0.25. The improvement in EPS, if realized, could signal a positive shift in PSTV's financial trajectory, offering a glimmer of hope for stakeholders looking for signs of recovery and growth.
As PSTV prepares to unveil its first quarter financial results for 2024, the management team plans to host a conference call and webcast to discuss the outcomes and provide updates on the company's operations. This event is not only a platform for financial disclosures but also an opportunity for PSTV to articulate its strategic direction and operational updates, offering a comprehensive view of its path forward in the competitive pharmaceutical landscape.
