Earnings Call Transcript - PSTV Q4 2021

Operator, Operator

Good afternoon, ladies and gentlemen, and welcome to the Plus Therapeutics Fourth Quarter and Full Year 2021 Results Call. At this time, all participants have been placed in a listen-only mode, and the floor will be open for your questions following the presentation. 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 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. 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, CEO

Thank you very much, David. Good afternoon everyone. 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 fourth quarter and full year financial results. Joining me on the call today is Andrew Sims, our Chief Financial Officer. In addition, joining Andrew and I on the call today for the first time is Dr. Norman LaFrance, our new Chief Medical Officer who joined Plus at the end of 2021. We are very excited to have Dr. LaFrance on board as he brings many years of highly relevant clinical regulatory and commercial expertise in radio therapeutics in oncology to the Plus Therapeutics management team. Welcome aboard Norman. I'll begin the call by reviewing our recent corporate and clinical progress before turning the call to Norman who will provide commentary on our clinical expectations for the remainder of 2022. Following Norman, Andrew will review our financials. 2021 and early 2022 has been marked by significant progress as we work toward our mission to become a global leader in developing precision targeted radio therapeutics for cancer. In 2021, we continued to advance our lead investigational targeted radiotherapeutic drug Rhenium NanoLiposome or RNL in our U.S. ReSPECT-GBM trial. As a reminder, the trial is a dual Phase 1/2 multicenter sequential cohort, open-label volume and dose escalation study. The trial is currently funded to a significant degree by the U.S. NCI or National Cancer Institute. Our initial indication for RNL is recurrent glioblastoma with defects approximately 30,000 patients annually in the U.S. and about the same number of patients in Europe. It's the most common and lethal form of brain cancer. And the treatment of this devastating disease remains a significant unmet challenge. We call also that RNL is a proprietary liposomal encapsulated radionuclide that is delivered locally regionally via targeted three-dimensional convection enhanced delivery. It is administered directly to the tumor, bypassing the blood-brain barrier. The activation is the rhenium-186 isotope, which is a dual energy emitter, releasing both cancer-killing beta particles, which are high energy electrons, as well as gamma particles, which are useful for imaging, localization and dosimetry. We provided positive interim data from the Phase 1/2 ReSPECT-GBM trial in patients with recurrent GBM at the Society for Neuro-oncology Annual Meeting and Education Day last November 2021, and then we updated the data set at the BIO CEO conference in New York this month. Both of those presentations can be found now on our website. According to the most recently presented interim clinical data set, RNL, delivered via convection enhanced delivery is feasible, up to at least 31.2 millicuries and 12.3 milliliters of volume. No delivery failures were observed. An average absorbed dose of 276 gray of radiation was delivered to the tumors over the course of the trial thus far. Average absorbed radiation to the tumor increased and correlated with dose escalation. In fact, we've shown that we can successfully deliver up to 740 gray, or 20 times the amount of radiation dose one can deliver with traditional external beam radiation in the recurrent setting. As an aside about radiation therapy, published studies indicate that external beam radiation provides the best incremental improvement in survival of all therapies currently available for glioblastoma, which is about five months of improved survival. And it remains to this day a central component of multimodal therapy for GBM and many other cancers. There's no question radiation works in GBM. Furthermore, in the ReSPECT trial, key drug delivery parameters such as flow rate, catheter, etc., were increased during the course of the trial. And that increase correlated with better drug delivery outcomes and improved overall survival. RNL also thus far well tolerated without dose-limiting toxicities, has an acceptable safety profile. There were no adverse events thus far in the trial with the outcome of death, or discontinuation due to adverse events and placement of up to four catheters in a patient thus far has been safe. As to efficacy, it's interestingly similar; the efficacy results thus far are similar to our preclinical results with absorbed radiation doses of greater than 100 gray in patients correlating with increased overall survival. Well, the Phase 1 trial is neither designed nor powered for efficacy, we are observing promising signals of both biological effect and increased overall survival. In the latter cohort of the trial, specifically cohorts five through eight, receiving greater drug volumes and radiation doses, and frankly more optimized delivery parameters, nine of the 12 patients or 82% of those patients in cohorts five to eight received a therapeutic dose of 100 gray or better. We believe it's entirely possible to achieve 90% or greater coverage of 100 gray or better moving forward. This far in 23 total subjects treated in respect with recurrent GBM, the mean and median overall survival for the entire group is currently at 38 weeks and 50 weeks respectively, with seven patients remaining alive. It's interesting to note that in this current trial, which was initiated by the academic physicians back in 2015, it's very unusual to have such long-term overall survival data which we do in this trial. Therefore, we take the logical step to take advantage of what's been done by the academics who started the trial and assess a subset of patients who received at least a minimum therapeutic dose of radiation. As I mentioned, that's greater than 100 gray of radiation. They were treated in the initial five cohorts, which range from the start date of March 2015 through to July 2020, which is the longer survival data we have in the trial thus far, and mean overall survival stands at 82 and 88 weeks respectively, with two patients still alive. That compares very favorably with the 32 weeks overall survival published in a recent meta-analysis of nearly 700 patients with recurrent GBM treated with Bevacizumab monotherapy in recurrent setting. Furthermore, our team continues to make excellent progress in drug scale-up and manufacturing activities. Specifically during Q1 in this 2022, the company entered into multiple collaboration agreements to support its process development in analytical chemistry activities, as well as to strengthen our supply chain in compliance with GMP practices for planned late-stage clinical trials. The company remains on track to deliver GMP RNL in mid-2022. Before I turn the call over to Norman, he will update you on the path forward for RNL. I'd like to highlight the agreement that we announced right at the beginning of January, consummated at the end of December. This substantially expands our portfolio. As we stated before, we fundamentally believe the future of cancer therapy is going to be in the precise targeting of tumors with the most potent cancer-killing agents while minimizing damage to normal tissues. To that end, we entered into an agreement with the University of Texas for a worldwide exclusive license to develop and commercialize novel interventional therapeutics for cancer. The licensed patents include composition of matter patents for biodegradable alginate microspheres, which we call BAM, containing the nano-liposomes loaded with imaging and our therapeutic payloads. Therapeutic payloads may include radio therapeutics, chemotherapeutics, or thermal therapeutics. The BAM technology is delivered into the vascular system via standard interventional vascular technology that are placed precisely in the vessels feeding blood to the tumors. Once injected, BAM both blocks all blood flow to the tumors and simultaneously delivers very high doses of cytotoxic compounds for an extended period of time. Many days later, following full radiation decay, BAM resorbs, is physiologically metabolized, and then excreted from the body. With this technology, we can target almost any solid organ tumor in the body using standard interventional radiologic methods to leverage the breadth of the human vascular system and deliver a resorbable biomaterial embolic technology coupled with a highly potent radioisotope. The company will initially focus on developing 188 RNL BAM as a next-generation radioembolization for liver cancer, in which BAM blocks the hepatic artery segments supplying blood to the malignant tumor, while also providing 188 RNL radiotherapy and directly irradiating the tumor. Next steps in this program are technology transfer from academia and completing IND-enabling CMC and preclinical work. And with that, I'll turn the call over to Norman.

Norman LaFrance, Chief Medical Officer

Thank you, Marc. I'm delighted to have joined Plus Therapeutics and to be joining you here today on this call. Plus Therapeutics is focused on radio therapeutics, positioning us firmly for long-term growth. I'm excited to lead the development and expansion of our promising pipeline. Following Marc’s comments on the ReSPECT-GBM trial in patients with recurrent glioblastoma, in 2022, we expect to materially advance the investigational drug RNL for recurrent GBM and other indications. First, we plan to meet with the FDA mid-year to propose taking our 8.8 milliliter and 22.3 millicurie as our recommended Phase 2 dose. We believe this dose is appropriate for 50% to 75% of patients with recurrent glioblastoma based on tumor size and morphology. As publicly announced earlier this week, we are currently exploring potential Phase 2 pivotal trial designs that may incorporate the use of real-world data, also known as synthetic control arms, to improve trial costs and facilitate enrollment. In addition, as we have yet to reach dose-limiting toxicity in the ReSPECT GBM trial, and we anticipate being able to treat larger tumors with RNL, our goal is to keep the Phase 1 dose escalation trial open and report data both on the previously treated patients and on future potential cohorts. We may also consider exploring improved drug dosing parameters. Recently, we have filed a new clinical protocol with the FDA to allow us to treat patients with recurrent glioblastoma previously treated with RNL as they may benefit from an additional RNL dose. GBM is notoriously difficult to eradicate in the brain and we believe a subset of patients may benefit in terms of greater safety and efficacy following two or more administrations of RNL. Furthermore, in 2022, the company will review other GBM disease subtypes to potentially expand the use of RNL. Regarding additional indications, RNL is also being developed for leptomeningeal metastases and pediatric brain cancer. Leptomeningeal metastases is an increasingly common secondary cancer, affecting over 100,000 patients per year in the U.S., and patients can present with a broad range of signs and symptoms due to simultaneous involvement in multiple areas of the craniospinal axis. We expect the LM trial to be a multicenter sequential cohort, open-label single dose, dose escalation phase one study, and will evaluate the maximum tolerated dose, maximum feasible dose, safety, and efficacy of the single administration of RNL via intraventricular catheter for the treatment of leptomeningeal metastases, following standard surgical radiation or chemotherapy treatment of these patients. The primary endpoint of the study is the incidence and severity of adverse events and serious adverse events and dose-limiting metastases, if any. Secondary endpoints include overall response rate, duration of response, progression-free survival, and overall survival. In addition, we have received FDA fast track designation for RNL for the treatment of leptomeningeal metastases. Following IND clearance from the FDA last year, in the fourth quarter of last year, the company began screening and consenting patients in the Phase 1 ReSPECT trial in patients with leptomeningeal metastases. Regarding pediatric brain cancer, based on our pre-IND meeting feedback received in 2021, the company expects to submit an IND for Phase 1 trial with RNL this year for the treatment of pediatric brain cancer and to investigate the use of RNL on children with brain cancer. At this point, I'll stop and turn the call over to Andrew for a brief review of the full year financial results. Andrew.

Andrew Sims, CFO

Thank you, Norman. And good afternoon, everyone. Please refer to our press release issued earlier today for a summary of our financial results for the full year ended December 31, 2021. As of December 31, 2021, cash and cash equivalents were $18.4 million, compared to $8.3 million as of December 31, 2020. Cash used in operations for the 12 months ended December 31, 2021 was $10.3 million, compared to $8.4 million in 2020. The main changes between 2020 and 2021 are as follows: In 2021 to early 2022, the company strengthened its balance sheet by raising approximately $28.5 million of capital. As of January 31, 2022, the company's cash balance was approximately $23 million, and our 2021 run rate represents over two years of operating cash. Research and development expenses were $5.3 million for the full year 2021, as compared to $2.7 million in 2020. This increase is primarily due to continued CMC development of RNL to GMP standard. The development remains on track to be completed by summer of this year, 2022. Please also note that the company continues to leverage the five year NCI grant awarded in 2015 to support preclinical activities. G&A expense was $6.9 million for 2021 as compared to $6.4 million in 2020. This increase is primarily due to expenses for new patent filings, professional fees related to the BAM transaction, together with other legal expenses and employee recruiting fees. Interest expense decreased by approximately $400,000 in 2021 from $1.3 million in 2020 to $907,000 in 2021. This decrease reflects the $5 million in principal paid off in 2020, with a further $300,000 in 2021. These payments reduce the remaining principal due to Oxford below $4 million at December 31, 2021. Net loss for 2021 is $13.4 million as compared to a net loss of $8.2 million in 2020. Excluding the gains on the warrant of $2.3 million that we reported in the first quarter of 2020, the change in net loss reflects the incremental R&D and G&A costs as mentioned earlier. And now I'll turn it back to you, Marc.

Marc Hedrick, CEO

Thanks, gentlemen. Before we move on to Q&A, let me just summarize some key milestones anticipated for 2022. I think we've touched on most of these already. First of all, with respect to the ReSPECT clinical trial in recurrent GBM regarding the RNL drug availability, the CMC activities for RNL remain on track to complete as planned. We have GMP Phase 3 drug supply available by mid-2022. We currently plan a CMC-focused FDA meeting in the second quarter of 2022 to clarify and resolve any open CMC issues that may exist at that time. We also plan a clinically focused FDA meeting mid-year to propose a Phase 2 clinical plan and trial design using the 8.8 ml and 22.3 millicurie recommended Phase 2 dose as Dr. LaFrance noted. We also plan to explore the use of real-world data, which is ongoing in the clinical and regulatory plan to accelerate Phase 2 enrollment and potentially reduce power costs. In 2022, we plan to continue to report Phase 1 data and provide enrollment updates in an ongoing manner in the current Phase 1 trial. Regarding the ReSPECT-186 RNL LM trial, our goal is to complete enrollment in at least the initial cohort of three patients this year. Regarding the pediatric brain cancer trial, we plan to submit an IND in 2022, and initiate this trial soon thereafter. Regarding our recently acquired rights to the 188 RNL BAM radioembolization therapy technology, we plan to complete the technology transfer and other key CMC and FDA IND enabling studies for this asset in 2022. So at this point, let's move to Q&A. And David, I'll turn it over to you.

Operator, Operator

Thank you. The floor is now open for questions. While live questions queue, we have previously received a question by email from Justin Walsh with B. Riley. This will be asked by Andrew Sims.

Andrew Sims, CFO

Thanks, David. First question is from Justin. Can you remind us how much of a barrier to potential adoption would you expect physician training to be? And are surgeons well equipped to make use of the asset?

Marc Hedrick, CEO

Yes, so there is a barrier, but it's 100% soluble. We've got two years of experience under our belt working with this novel technology. And we think about it in a couple of ways. First of all, there's the neurosurgical aspect. The second part is the case planning aspect which is really about getting radiation on the tumor. In terms of the neurosurgical aspect, essentially, getting the catheters in the tumor leverages existing, tried and true brain biopsy technology. It's commonplace in hospitals that have neurosurgical services. The technology itself allows very precise delivery within about a millimeter or so and actually, there are many navigation systems that allow that sort of geospatial delivery technology to be the place we prefer the brain labs technology, that's one that we've used. In fact, I've gone through the full training with my neurosurgeon and I feel after a day of training, I’m 100% capable of doing that. So part of that I don’t think is the barrier. What initially worried us about maybe two years ago when we acquired the asset is how we ensure that we can reliably cover the tumor with the appropriate amount of radiation. And I think the story is adequately told in the ReSPECT clinical trial data. If you look back at cohorts, one through four, Justin, we were only able to cover the tumor with adequate radiation greater than 100 gray about 40% of the time. But if you look at the wider cohorts, I think I referred to this in the script, like cohorts five to seven where we've got more volume and higher radiation doses, just more catheters, higher flow rate, etc., we're able to cover the tumors with therapeutic radiation about 80% plus of the time in those cohorts. And I'm increasingly comfortable that we're going to achieve that to 90% or greater. So, in terms of implementation of the case planning, currently and through the clinical trials, we'll do that centrally. We think it's really important; from a quality control perspective, we do that corporately in consultation with the treating neurosurgeon. And that may be the model going forward commercially. We just don't know but basically, we're very confident now that those barriers are well on the way to being resolved.

Andrew Sims, CFO

Justin’s second question is, can you provide some additional color on a regulatory precedent for using a synthetic control arm? What are some of the potential advantages and disadvantages of that trial design approach?

Marc Hedrick, CEO

Normally, would you mind answering that?

Norman LaFrance, Chief Medical Officer

Yes, I'll be happy to. Thanks. It's a great question from Justin. I'll jump right to the bottom line that this real-world data and synthetic control arm data already have established precedent successfully for interaction with the FDA. Folks on the call may be aware of Celsion's OVATION 1 study in ovarian cancer, with their Gen 1 asset, and also the Athena in glioblastoma. So this approach has been used successfully with recurrent glioblastoma with previous drug review groups within the FDA. Now spend one second if you allow me to go over in general why an SCA real-world approach will be valuable, and particularly focusing on our application. So the first thing we will do is take advantage of this existing data and their significant data with the expert group who are dealing with this for understanding of our early phase single-arm trial data that Marc mentioned. And Marc mentioned that this doesn't have a Phase 1 efficacy control arm; we'll be able to rectify that with a synthetic control arm, respecting the enrollment criteria that we had in that Phase 1. So with this phase one we believe to have, we'll begin generating additional data beyond the very impressive overall survival data that's been reported at the SNO Annual Meeting last year demonstrating a strong overall survival benefit with the synthetic control arm validation. This all leads to the capability to analyze and justify advancements to Phase 2 with the FDA. As you heard from both Marc and I, we plan on approaching the FDA by mid-year for this Phase 2 pivotal advancement. The availability of a control arm means that the randomization for control active treatment will not be one-to-one. That will encourage these unfortunate patients to enroll in their studies. It's always a personal decision. Patients understandably would like active treatment. This in turn accelerates development faster to market and commercialization and saves development costs. So Marc, I don't know if you have anything else on it, but I think that that's a lot of the reasons why this approach is valuable. And we have great expectations for helping move development even faster than anticipated.

Andrew Sims, CFO

That's great. Thank you. Maybe it's a follow-up question. So David, I'll turn it back to you for the questions.

Operator, Operator

Of course, we'll take our first live phone question from Jianing Li with Maxim Group. Please go ahead. Your line is open.

Jianing Li, Analyst

Hi, this is Jianing. Thank you for the question and congratulations on the progress this quarter, particularly regarding the positive data shared at the SNO. Considering the higher overall survival rate in the elevated dose cohorts, could you please reiterate the dosing strategy for the next trial? Will it be at or above 100 gray, and what volume will be used? Additionally, could you provide some insight into what would be deemed a meaningful extension of overall survival in the recurrent GBM setting, especially as the survival benchmarks continue to evolve?

Norman LaFrance, Chief Medical Officer

Yes, I'll take that. Thank you, Jianing. So the first part of the question, the dosing plan: we back up so we bifurcated the trial, continue to Phase 1 and continue the current dose escalation scheme. I can walk you through that if you're interested in what that is. But right now, we're dosing cohort eight, it's about 12 CCs of volume, I think 31 millicuries of radiation. Moving into the Phase 2, the plan is to take the prior dose at which we have six patients, which is what the trial is designed sufficient to move into a Phase 2 recommended dose, which is at 8.8 CCs and I think about 21 millicuries. So we've got the DLTs, and we've got a very accessible safety profile. The dosimetry data from the clinical trial shows that we can cover not only the tumor, but also a rim of the brain tissue that appears normal by imaging, but we know is very likely to harbor microscopic disease, and we need to treat that as well to get long-term survival benefit. So we think that 8.8, 21, 23 millicurie dose will treat small to medium-sized tumors, and we believe that's a totally appropriate dose to take into Phase 2 based on the data we have so far. We'll continue to dose escalate in the effort to potentially treat larger tumors or with more complex morphologies that are difficult to cover with the current volume and dosage. So as to the target in terms of the amount of radiation, we've seen that 100 gray or greater seems to be therapeutic. Only 23 patients at this point show a pretty clear biological signal as we dose escalate. It's interesting, as I mentioned in the script, that the preclinical data showed exactly the same thing that you start seeing statistically significant improvement in survival when you deliver over 100 grays to the tumor. And the interesting thing is, we're now delivering 740 grays. And we're managing to do that with seemingly a pretty good safety profile. So that's the plan moving forward. If you have any further follow-up questions, I'm happy to try to address those.

Jianing Li, Analyst

Great, and just regarding the trial size and the current GBM. Can you do a registration study with the single arm of 100 patients and get approval? Because we've seen drug screening approvals and other indications in a severe unmet need setting through that pathway. And just as a follow-up, you mentioned the use of the recent data control in the next trial, could you give us some details for that around a decision? And as an approach we've observed. Ahat da be more open to in recent years, particularly in GBM?

Marc Hedrick, CEO

Yes, it's a little too early to tell what the trial size looks like from the budget, and so forth. But we've said previously and I think we still believe this, we have no reason to believe differently that approximately 100 patients is about the size of that trial. As we've mentioned previously, we have designation for that indication. And we have fast track status for the program with the FDA. We believe, based on the data and what we know about the break-even designation pathway, that that may be an alternative here as well. So that's what we're thinking right now. The synthetic control arm, as Norman mentioned, might offset the total number of patients we randomize. And kind of your follow-up question on the synthetic control arm, Norman alluded to this that there has been approval from the FDA to go into a Phase 3 design using a real-world synthetic control arm to have a control group that is an amalgam of patients who have been randomized to the control group but to supplement that with real-world data that are identically matched to the enrollment and exclusion criteria of the trial. So there's an increase in the well-worn path of the FDA where they've accepted it, particularly in diseases like GBM. And I think we're increasingly confident that we think that that's going to be useful here as well.

Jianing Li, Analyst

Great. Sounds very helpful. Thanks again.

Marc Hedrick, CEO

Thank you.

Operator, Operator

We'll take our next question from Sean Lee with H.C. Wainwright. Please go ahead, your line is open.

Sean Lee, Analyst

Good afternoon, guys. And thanks for taking my questions. So I just have a couple of your clinical development plans. So the first question is, you guys mentioned you wanted to try reducing your patients. Now, sometimes that means that within the same Phase 1 study, we do expect in cohort for that.

Marc Hedrick, CEO

Hey, Sean, it’s Marc. This would be a separate protocol and not part of the Phase 1 design, meaning it won’t fall within the NCI framework. So it will have its own protocol, but it will be under the IND. We have recently received confirmation from the FDA about our ability to proceed with that.

Sean Lee, Analyst

I see. In terms of that, what kinds of patients are you specifically looking to redose? What doses will you be studying them on?

Marc Hedrick, CEO

So, yeah, it's a great question. So it's almost impossible to eradicate GBM. And that's kind of why we've seen in a dose escalation trial that even though we've had a number of long-term survivors, one survivor that's 160 weeks out, almost three years that we still can't eradicate it. There are kind of two patients, there are the patients where maybe the morphology of the tumors is not ideal. It’s difficult to cover the tumor; the anatomic location is challenging, and so forth. And we know right off the bat that there might be an area at risk for recurrence based on the dosimetry datasets. The type of patient where we know right off the bat that there may be a problem, we want to be hyper-vigilant about recurrence so we could retreat those patients. The other type of patient is where we've got good coverage. The patient does well; we’re seeing a safety and potentially efficacy signal in that particular patient. But if the disease comes back, as it typically does, we want to be ready to retreat them. So the plan is to take the requesting here to take the cohort six dose, that's the one we're taking the recommended Phase 2 where we have six patients treated; that would be the maximum dose. We could potentially go down based on the size of the image recurrent tumor, but that would be the planned maximum dose going into that retreatment protocol.

Sean Lee, Analyst

I see. Thanks for that. In terms of testing these retreatments and also testing higher doses in the Phase 1 study. If you do see some improved outcomes from these treatments, would you delay your Phase 2 to incorporate these or are you happy with, I think, 8.8 ml that you guys have set off?

Marc Hedrick, CEO

Yes, we are satisfied with that. I believe it is dependent on tumor size. We have mentioned this before, and I have discussed it as well. The idea is to cover the tumor and include what looks like normal brain tissue because 90% of recurrences occur in a 2-centimeter area around the primary tumor. Therefore, we want to include that, which is very much linked to tumor size. At higher volumes and doses, we can treat larger tumors. This is the rationale, and the escalation arm continues to accept larger tumors for treatment. In terms of retreatment, patients are imaged every 60 days, so we believe we can be attentive and proactive in addressing any signs of recurrent disease and manage it effectively. The volume requirement for radiation dose may be slightly lower than what we would administer during the first recurrence.

Sean Lee, Analyst

I see. Thanks for the clarification. My last question is on the BAM product. So from the sounds of it, liver cancer may be one of the first issues that you guys go after with this product. And while it's a very rare cancer here in the U.S., it's a very common one out in Asia, especially China and Japan, they will move quickly. So something like international collaboration to test it in those countries would be something that you guys would consider?

Marc Hedrick, CEO

I completely agree. That's consistent with our thinking as well. In fact, we've already had partnering interest on that even as early as it is. But I think the cautionary note is that we're still early in the tech transfer, and in the other IND-enabling studies. So I think we still have a year of work before we're ready to discuss publicly the clinical trial plan. But I don't see a scenario where we wouldn't include a trial plan that would not include sites in the Asia-Pacific region.

Sean Lee, Analyst

I see. Thanks. That’s all I have.

Marc Hedrick, CEO

Thanks, Sean.

Operator, Operator

And there are no further questions on the line at this time. I'll turn the floor back to Dr. Hedrick for any additional or closing remarks.

Marc Hedrick, CEO

Thank you, David. Let me just close by thanking everybody for joining us on the call today. Thank you for listening to the recorded version. And on behalf of the board, I would like to thank our employees, specifically our team members, welcome Dr. LaFrance, the physicians we work with, and of course, we're always grateful for the patients that trust us and enter into our clinical trial. So thanks again for your participation and have a good evening. Bye bye.

Operator, Operator

This does conclude today's program. Thank you for your participation. And you may now disconnect.