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Oncolytics Biotech Inc.
8/1/2024
Good afternoon and welcome to Oncolytics Biotech's second quarter 2024 conference call. All participants are now in a listen-only mode. There will be a question and answer session at the end of this call. Please be advised that this call is being recorded at the company's request. I would now like to turn the call over to Jan Patton, Director of Investor Relations and Communication.
Please go ahead. Thank you, Operator.
Earlier today, OnClinics issued a press release providing recent operational highlights and financial results for the second quarter of 2024. A replay of today's call will be available on the event section of the OnClinics website. And after remarks from company management, we will open the call for Q&A. As a reminder, various remarks made during this call contain certain forward-looking statements relating to the company's business prospects and the development and commercialization of Pella Reader App. including statements regarding the company's mission, strategy, and milestones, the company's belief as to the potential and mechanism of action of Pell Rear Up as a cancer therapeutic, our belief that we are positioned to execute on our key priorities and reach multiple milestones throughout the second half of the year and into 2025, our potential registrational opportunities for Pell Rear Up, anticipated timing of the release of additional data, our cash runway, and other statements related to anticipated developments in the company's business. These statements are based on management's current expectations and beliefs and are subject to a number of factors which involve known and unknown risks, delays, uncertainties, and other factors not under the company's control that may cause actual results, performance, or achievements of the company to be materially different from the results, performance, or expectations implied by these forward-looking statements. In any forward-looking statement in which Oncleric expresses an expectation or belief as to future results, such expectations or beliefs are expressed in good faith, and our belief to have a reasonable basis, but there can be no assurance that the statement or expectation or belief will be achieved. These factors include results of current or pending clinical trials, risks associated with intellectual property protection, financial projections, actions of regulatory agencies, and those other factors detailed in the company's filings with CDAR and the SEC. OnClinic does not undertake any obligation to update these forward-looking statements except as required by applicable laws. Joining me to discuss the substantial progress made during the second quarter are a few members of the management team, including Chair of Oncologics Board of Directors and Interim CEO, Wayne Pisano, Chief Medical Officer, Dr. Tom Heinemann, Chief Financial Officer, Kirk Look, Vice President, Business Development, Christophe Degois. And with that, it's my pleasure to turn the call over to Wayne. Wayne?
Thank you, John. Good afternoon. I appreciate everyone taking the time to join us today. Well, I know you are accustomed to our CEO, Matt Coffey, leading these presentations. Personally, and on behalf of the Board, I'd like to wish Matt a swift recovery. In the interim, the Board and I are highly confident in our tenured executive team's ability to continue executing our mission, achieve our strategic priorities, and deliver on our long-term goals, and ultimately bringing fellow REOF to patients with cancer. Following my brief introduction, Tom will provide an update on the clinical advancements. Christoph will discuss recent collaborations and partnership opportunities. Kirk will review the financials. And finally, we will end by taking your questions. In the second quarter of 2024, we continue to make excellent progress in advancing our potentially leading immunotherapeutic agent, Pella-Riorep, or Pella as we often refer to it. We believe we are well positioned to execute on our key priorities and reached multiple milestones for the second half of the year and into 2025. Now, before Tom provides a comprehensive update on our progress and how recent activities continue our mission to improve the lives of people with cancer, I would like to highlight a few important advancements. Notably, we held an extremely productive Type C meeting with the FDA and we are able to communicate what we consider to be the optimal path for Pella and breast cancer going forward. With input from the agency, we were able to align our key elements for the next steps we plan to take and are bolstered by compelling data from two randomized breast cancer studies showing the benefit of Pella combined with Paclitaxel compared with Paclitaxel monotherapy. This gives us confidence in Pella's potential to demonstrate a clinically meaningful benefit in a future registration-enabling study. Importantly, we remain on track to report overall survival results from the Bracelet 1 trial in the second half of 2024. Looking at the opportunity in pancreatic cancer, we dosed the first patient in the modified Fulfironox cohort of the GOBLIN study. This represents an exciting opportunity to evaluate the combination of Pella with another first-line pancreatic cancer chemotherapy regimen that could result in a second registration program in this indication. As you may recall, this opportunity came about as a result of positive data demonstrating that the combination of Pella, tesolizumab, gemcitabine, and napaclitaxel in pancreatic cancer patients more than doubled the tumor response rates compared to the response rates for chemotherapy treatment alone. That data set not only garnered fast track designation from the FDA, but it also brought us to our collaboration with the Global Coalition for Adaptive Research, or GCAR, where this combination will be evaluated in an adaptive registration enabling trial. As we near a critical inflection point in the company's growth trajectory, We are encouraged by the recent regulatory and clinical progress and look forward to building on this momentum. I would now like to turn the call over to Tom to provide a more detailed update. Tom?
Thank you, Wayne. As a reminder, Pella is an intravenously delivered immunotherapeutic agent that acts systemically, inducing anti-cancer immune responses and promoting an inflamed tumor phenotype that is turning cold tumors hot. This allows the anti-tumor immune cells induced by Pella to attack the cancer. As Wayne mentioned, we are currently focused on advancing Pella toward registrational studies in breast and pancreatic cancer. We have exciting data and other indications like anal cancer that could eventually lead to additional registrational opportunities, but for today, we'll just focus on breast and pancreatic cancer. Starting with our breast cancer program, I'd like to touch on two topics. our recent productive Type C meeting with the FDA, and the anticipated Bracelet One study's survival results. In June, we provided a recap of our Type C meeting with the FDA. We had a very productive and helpful discussion with the agency that provided valuable guidance on our proposed registration-enabling study. One perhaps underappreciated takeaway was that the FDA endorsed progression-free survival as the primary endpoint of the study, with overall survival as a secondary endpoint. Having progression-free survival as the primary endpoint mirrors the path taken by Pfizer for the initial approval of Ibrants based on the Paloma 1 study and could save substantial development time by allowing us to reach the potential registrational endpoint sooner. The patient population for the registrational study is anticipated to include patients who have failed hormonal therapy and have received no more than one line of antibody drug conjugate therapy. Our de-risked Breast Cancer Program builds on compelling data and key learnings from two prior randomized studies, Bracelet 1 and IND213, which demonstrated clinically meaningful benefit in patients who were treated with Pella and Paclitaxel compared to Paclitaxel alone. I should also mention that we have translational data from the AWARE-1 study that provided valuable insights into Pella's immune-mediated mechanism of action, including its ability to remodel the tumor microenvironment. Aligning with the FDA on key design elements and objectives of our planned registrational trial marks a critical step toward bringing this innovative treatment to patients. Next, I'd like to move on to the anticipated Bracelet 1 survival data. As a reminder, Bracelet 1 is a phase two randomized study in patients with HR-positive, HER2-negative metastatic breast cancer. The study enrolled 48 patients into three cohorts. Patients in cohort one received paclitaxel, which served as the control arm. Patients in cohort two received paclitaxel plus Pella, and patients in cohort three received paclitaxel, Pella, and the checkpoint inhibitor, Ovalumab. We previously reported strong tumor response and progression-free survival results from the BRACEL1 study. These included a near tripling of the confirmed overall response rate, a greater than 50% improvement in median progression-free survival, and a hazard ratio of 0.29 for patients receiving Pella and Paclitaxel compared to Paclitaxel alone. Overall survival results have not yet been reported due to ongoing patient follow-up, but are anticipated later this year. As noted, the earlier IND213 study showed a statistically significant survival benefit in HR-positive HER2-negative metastatic breast cancer patients who received the combination of Pella and Paclitaxel compared to Paclitaxel alone. A strong overall survival readout in the Pella Paclitaxel arm in the Brace of One study will serve to further validate these earlier findings and support continuing discussions with potential strategic partners and regulators. Now, turning to our pancreatic cancer program, I'd like to start by highlighting our new Goblet Study cohort, which is supported by a $5 million therapeutic accelerator award from the Pancreatic Cancer Action Network, or PANCAN. PANCAN launched the Therapeutic Accelerator Award to speed up pancreatic cancer drug development so new therapies could be made available to patients sooner. By way of background, the Goblet Study is a Phase I-II signal-finding study in advanced or metastatic gastrointestinal cancers. The study is being conducted across 17 centers in Germany and is being managed by AIO, a medical oncology working group within the German Cancer Society. To date, we have evaluated Pella in first-line metastatic pancreatic ductal adenocarcinoma, or PDAC, third-line metastatic colorectal cancer, and second-line or later, anal cancer. In each of these indications, the Pella-based combination therapy met the pre-specified success criteria. Pancreatic cancer has one of the lowest survival rates among all cancers, and is the third leading cause of cancer mortality in the U.S. Despite its growing incidence, efforts to improve upon the standard of care have met with limited success over the past several years. In June, we announced the dosing of the first patient in our new Goblet Study cohort, evaluating Pella combined with modified fulfirinox with or without atezolizumab in newly diagnosed metastatic PDAC patients. This study utilizes assignment two-stage design, and the co-primary endpoints are objective response rate and safety. If stage one success criteria are met, one or both treatment arms may be expanded to stage two, in which 17 additional evaluable patients per arm would be enrolled. The chemotherapy regimens of modified fulfirinox and gemcitabine nabpaclitaxel are the two most common standards of care in metastatic pancreatic cancer. We previously reported that the combination of Pella, gemcitabine, nabpaclitaxel, and atezolizumab yielded tumor response rates more than double the historical results. Should the combination of Pella and modified fulfirinox also produce a positive outcome, it would indicate that an even broader range of metastatic PDAC patients may benefit from Pella-based therapy. Importantly, this treatment regimen could result in another registrational opportunity for Pella in this challenging indication. While we believe there's an exciting opportunity for Pella combined with modified fulfirinox, our immediate registrational strategy in PDAC continues to focus on Pella combined with atezolizumab, gemcitabine, and nabpaclitaxel based on the very positive results from the GOBLET study. We continue to collaborate with GCAR to design a study utilizing an adaptive approach to evaluate this combination therapy, and we look forward to providing an update as our plans are finalized. Before I turn the call over to Christoph, who will discuss our GCAR collaboration in more detail, I would like to briefly mention our two presentations at this year's ASCO meeting. Details of the trial design for our new Goblet Study Pancreatic Cancer Cohort, in which Pella is combined with modified Fulfironox, were presented. Additionally, we presented an abstract detailing Pella's ability to induce the expansion of tumor infiltrating lymphocytes, or TILs, across multiple cancers, including breast, pancreatic, and colorectal cancer. Pella's ability to expand TIL populations is important because TIL expansion correlates with tumor response. These data further highlight Pella's immunotherapeutic mechanism of action and its promise as a backbone immunotherapy for multiple cancer indications. Taken together, we are extremely excited about the advancements across our pipeline and the growing body of clinical data showcasing Pella's broad therapeutic potential. With that, I will turn the call over to Christoph, who is joining us for the first time on a financial results call. He will be heading up our business development efforts going forward and is here to discuss our recent collaborations and partnership opportunities. Christoph?
Thank you, Tom. I'm excited to join the team. and see a real opportunity for Pella and Oncolytics to make an impact in treatment of cancer, so I'm thrilled to be here. In the second quarter, we enter into a preliminary collaboration with GCAR, which we believe underscores the strength of the growing Pella data set that continues to attract and pique the interest of the clinical oncology community. GCAR is a nonprofit corporation uniting physicians, clinical researchers, advocacy and philanthropic organizations, biotech pharma companies, health authorities, and other key stakeholders in healthcare. PCAR's objective is to expedite the discovery and development of treatment for patients with rare and deadly diseases. As a sponsor of innovative trials, including master protocols and adaptive platform trials, GCAR is dedicated to the advancement of science by modernizing clinical trials that support more efficient, less costly drug development. We are pleased to partner with GCAR and are honored that PELLA has been selected as the first therapeutic for evaluation in their planned adaptive trial in pancreatic cancer patients. The selection process was thorough and involved meeting with and presenting our clinical data to multiple pancreatic cancer key opinion leaders. We are working together to finalize a phase 2-3 master protocol design that will evaluate PELLA and other investigational therapies for the treatment of pancreatic cancer. GCAR's anticipated trial design seeks to cut registration or study time and reduce trial costs, speeding up the journey to potentially deliver effective cancer treatment sooner. This strategy, which includes leveraging GCAR extensive investigator network, offers a cost-effective opportunity to enhance our ability to quickly and effectively advance the development of this Pella-based combination therapy for metastatic pancreatic cancer, a disease with a very high unmet medical need and limited treatment options. Beyond GCAR, we intend to continue to seek strategic opportunities to collaborate and maximize the therapeutic and commercial potential of Pella. We have an ongoing dialogue with current and potential collaborators and believe additional data updates will continue to strengthen our value proposition. I will now turn the call over to Kirk to review the financial results for the second quarter of 2024. Kirk?
Thanks, Christophe, and good afternoon, everyone. I'd like to briefly run through our financial results for the second quarter of 2024, which will be provided in Canadian dollars unless otherwise noted. A full summary of our financial results can be found on the Investors section of our website under Filings and Reports or in the press release issued earlier this afternoon. We continue to be cognizant of our cash resources and make the necessary investments to progress Pella's development while ensuring we have funds needed to reach critical milestones. As of June 30, 2024, the company reported $24.9 million in cash and cash equivalents, with the projected cash runway into 2025. Net cash used in operating activities for the six months ended June 30th, 2024 was $14.3 million compared to 16.3 million for the six months ended June 30th, 2023. The change reflected non-cash working capital changes partly offset by higher net operating activities in 2024. Now, general and administrative expenses for the second quarter of 2024 were 3.4 million, consistent with 3.5 million for the second quarter of 2023. Research and development expenses for the second quarter of 2024 were 4.6 million, compared to 3.7 million for the second quarter of 2023. The increase was primarily due to higher clinical trial expenses, including bracelet one data analysis and the GCAR collaboration. and higher share-based compensation expenses. The increase was partly offset by lower production run and process and analytical development activities in manufacturing. The net loss for the second quarter of 2024 was 7.3 million compared to a net loss of 7.4 million for the second quarter of 2023. The basic and diluted loss per share was 10 cents per share in the second quarter of 2024 compared to a basic and diluted loss per share of 12 cents in the second quarter of 2023. Now, this is an exciting time for the company. And as we conclude today's call, I would like to highlight a few critical events that we believe move us closer to our ultimate goal of regulatory approval for Pella. In the second quarter of 2024, we continued to propel Pella towards registration enabling studies in breast and pancreatic cancer. We established a strategic collaboration with GCAR and continue to have productive discussions with key opinion leaders, our clinical collaborators, and regulators. In summary, we received productive feedback from the Type C meeting with the FDA for our planned registration-enabling trial for Pella and HR-positive HER2-negative metastatic breast cancer and expect to provide further guidance on the path forward in the second half of the year. We continued following patients from the Bracelet 1 breast cancer study and remain on schedule to report overall survival data in the second half of this year. We entered into a collaboration with GCAR for inclusion of Pella in an adaptive registration-enabling pancreatic cancer trial and expect to finalize the master protocol for Pella, gemcitabine, nabpaclitaxel, and atezolizumab in the second half of 2024. With our collaborators, we then plan to initiate the adaptive registration enabling trial in the first half of 2025. We dose the first patient in the new goblet modified Fulfironox pancreatic cancer cohort supported by funding from PANCAN, which could result in another registrational opportunity for Pella. We expect to report a safety run-in update in the second half of the year. Taken together, we believe our robust, positive clinical and translational data support Pella's MOA. as an immunotherapeutic agent and potential to improve the lives of people with cancer. Before we conclude today's call, I would like once again to thank the entire Oncolytics team, our investors, and the many people who are supporting us along the way, including our patients and their families. With that, we are happy to take questions. Operator?
Thank you. Ladies and gentlemen, we will now begin the question and answer session. Should you wish to ask a question, please press star followed by number one on your telephone keypad. You will hear a prompt that your hand has been raised. And should you wish to cancel your request, please press star followed by the number two. And if you're using a speakerphone, please lift your handset before pressing any keys. Once again, star and one if you wish to ask a question. And we will now take our first question. This comes from the line of Luis Chen from Cantor. Please go ahead.
Hi, good afternoon, everyone. This is Carvey on for Luis from Cantor. Thanks for taking our questions. First, can you remind us of the size of the commercial opportunity for Pella and HR plus for two minus metastatic breast cancer? And second, what would your registration trial design look like? Thank you.
Thanks for the questions, Kirby. First, I'll turn it over to Christophe to speak to the market.
Yes, hi. Yeah, I mean, as you may know, I mean, this is a very changing environment with obviously, you know, some ADCs, NO2 in particular, you know, making some obviously some changing a lot of this market. and based on recent data. So we're currently in the process of updating the commercial opportunity and I think in the next call we'll be able to provide more detail. There's still a significant commercial opportunity if you think about the way NO2 is going to be used in these patients. Obviously, you know, they are going to, they're not approved yet, but I think it's very likely that they would come, you know, right after, you know, the hormonal therapy. But unfortunately, as you know, this patient will still relapse. And you need a subsequent line of treatment. And we believe, you know, there's a significant commercial opportunity in R02 failures. And also, we need to consider, you know, the patient who will not be eligible to R02 because of very low R02 levels or other, you know, conditions that may prevent the use of an ADC with these patients.
Then I'll ask Tom to respond to the plan.
Yes, so we expect to move forward with our next trial in the form of a registration-enabling large phase two study with a primary endpoint of progression-free survival and in the population that Christoph actually described, which is patients who have either failed antibody drug conjugate therapy following progression on hormonal therapy or patients for whom antibody drug conjugate therapy is inappropriate or who cannot tolerate such agents. So we, and this study would allow us with two opportunities to win. If it meets a high level of significance for the investigational arm, it would, put us in the position of applying for an accelerated approval. And at a very minimum, it would substantially de-risk any subsequent trial that we would conduct to confirm the efficacy of the combination therapy.
Great. Thank you so much.
Thank you. And the next question comes from the line of John Newman from Canaccord. Please go ahead.
Hello. Thanks for taking my question. Excuse me. I also had a question about the registration enabling study for pylori rep in breast cancer. I'm assuming that most of the patients, if not all the patients, enrolling in the study will have previously been treated with an ADC. Is there any specificity as to which ADC? And then the second question that I had was just in terms of the geography of the study, would this be primarily a U.S.-based study, or would you also include patients from Europe? Thanks.
Yeah. So, John, I can comment on that. So, I think the – as Christoph said, the – treatment approach in patients as it relates to the antibody drug conjugates is still evolving, right? So I don't think anyone can say with precision exactly what proportion of patients in our study would have failed antibody drug conjugate therapy. But I think it's very, very reasonable to assume that the majority of them would have received antibody drug conjugate therapy. There will be patients who are not appropriate for antibody drug conjugate therapy or who take it for a short period of time and cannot tolerate it. So there will be patients who come into the study through other pathways. But at present, the data that are available in the population we're looking at would suggest that the antibody drug conjugate therapy that would be most in play, that is to say the therapy that patients would have failed before coming into our study, would be in HER2. That's the agent for which the data currently exists suggesting a solid benefit immediately following the failure of hormonal therapy.
Oh, in the geography, yes, I'm sorry.
Yeah, this study, we would anticipate that this study would have a substantial enrollment in North America, of course, and we're currently evaluating possible other geography for enrollment, it seems reasonable to expect that there would be sites in some of the major Western European countries, for example. And beyond that, we need to consider our options. Thank you.
Thank you. And the next question comes from the line of Samit Roy from Jones Research. Please go ahead.
Good afternoon, everyone. Possibly a question for Tom. The Bracelet 1 trial, have you disclosed p-value, or was it too small of a cohort size? And second question is, for the Phase 2, 3 registration trial in breast cancer, do you expect potentially a portion of patients being treated with ADC as the only major variable difference between Bracelet 1 and Phase 2, 3? Or do you see other changes could be there, differences between bracelet and the phase 2-3?
Yeah. So we have the P value for the PFS comparison. OK. And the comparison, the P value for the comparison between Paclitaxel and the Paclitaxel plus Pella rear rep arm was 0.03. So it was less significant at less than the 0.05 And with regard to the differences in the bracelet population, yes, I mean, I think you're right. We would be enrolling patients in this study, as discussed already, who have failed ADC therapy, which were not enrolled in bracelet because they simply did not exist at that time. But otherwise, the patient population would be essentially identical to the bracelet patient population.
A quick follow-up, but do you expect to – do any sub-analysis separating out those patients with prior ADC in phase 2-3, or how are you thinking about this?
Well, we haven't formalized our analysis plans to that level, but I'm sure that we would be looking at any distinctions between significant population groups within any randomized study.
Thank you again, and congrats on the progress. Thank you.
Thank you. And the next question comes from the line of Michael Kumerwick from Maxim Group. Please go ahead.
Hey, guys. Thank you for taking my questions today.
I just want to see if you could help clarify the nature of the additional registration opportunity that you're saying could emerge from cohort five of the GOBLET study. Is there an expectation here that you could file for accelerated based on that data, or are you referring to the ability to launch a second registrational study based on that data?
Yeah, so the data that we're generating in Cohort 5 of the Goblet Study, we view that as a kind of signal-finding proof-of-concept data. We would not expect that those data would support in and of themselves an accelerated approval. However, as you know, we are planning to move forward with the other combination, the Pella plus the gemcitabine, NAPAQ, Litaxel, in through the collaboration with GCAR, right, which is a, which would be in a registrational approach. And it is certainly possible if the cohort five results look good and turn out the way we hope and expect they will, that that combination could be evaluated, for example, in a, in a platform study such as what we're doing with GCAR already or through some other mechanism.
All right, thank you. That's very helpful. And then one other for me, and I'll hop back in the queue.
I wanted to see if you had any expectations on the size of the potential pivotal study in breast cancer that you need based on the prior PFS data that you have for Pela in this setting.
Yeah, what we're looking at, I mean, the model,
that we're following is very similar to the approach that was used by Pfizer, for example, for their initial licensure of iGrants, and then subsequently by Daiichi for the initial licensure of Inher2. So what we'd be looking at would be a study of sub-200 patients, 180, 200 patients, somewhere in that order of magnitude.
All right. Thank you very much, and wishing for a speedy recovery from that. Thank you. Thank you.
Thank you. And the next question comes from the line of Rahul Sarugasar from Raymond James.
Please go ahead. Good afternoon, gents. Thanks so much for taking our questions. And also, I'll just reiterate Jason's point about wishing a speedy recovery from that. But also following up from Jason's question, Talking about the, you know, now that you're through the type C meeting and you're looking at setting up the breast cancer trial, these patients are effectively going to be second, third line after, you know, after expelling hormone or potentially an ABC. So perhaps you can let us know, you know, give us a sense of your confidence on patient recruitment, the number of sites you'll need to be able to, you know, fill the study out. And, you know, how fast do you think you'll be able to recruit, given that we think that, you know, that this can be a relatively competitive patient group?
Well, I mean, I think that keep in mind that we are not, for the breast cancer, the next study in breast cancer, we are not planning to compete with NHER2, right? We would be coming in, you know, and recruiting patients who can either not receive in HER2, for example, or who have failed in HER2. And for those groups, the only options really available are traditional chemotherapy for the large majority of those patients. And so actually, to the contrary, I suspect that there will be a pretty high demand for patients' participation in a study that offers something with a, you know, with clear earlier data that improves upon standard of care chemo, if you see what I'm saying. In other words, I think there will be plenty of patients who would be looking for better options than what would otherwise be available. So I would anticipate that the enrollment into the study would be, you know, reasonably straightforward.
That's helpful, really. Thank you very much. That's very helpful. And now, just as a follow-on, pivoting to the goblet study and PANCAN, could you perhaps give us a little sense for the destination at which point partners might be interested? Is there a set of outcomes or interim readouts that you think would engender that interest?
Yeah, Rahul, thanks for the question. That's a, you know, that's a challenging one. Our expectation is on the pancreatic cancer side of things is that, you know, we will, as we see the GPR study, the first part of the adaptive design study readout is that we'll be able to leverage that and, you know, go out specifically with that information. to speak to potential partners. What we do find interesting on the cohort five on the goblet side of things with the modified falfironox combination is, you know, we think that that can be quite interesting because if it shows similar data as to cohort one with the Gemnab-paclitaxel combination, we think that we have an opportunity to capture a large percentage of the pancreatic cancer treatment market in this particular stage. So we will take advantage of that data and those results when they come out, and then we'll start to obviously outreach towards partners at that time. That said, though, prior to that data coming out, we will have And things are progressing as expected on the bracelet, overall survival analysis. And so that's, you know, happening much quicker. And so we'll be looking to perform some meaningful outreach with that information in hand, you know, subject to the results earlier than what we see out of the pancreatic cancer cohorts.
Perfect. You answered my other question. So thanks very much, Kirk. Really appreciate it. We'll get back in the queue and best wishes to Matt.
Thank you.
Thank you. That concludes our conference, I mean the Q&A session for today. And I will now hand back the call to Kirk Luke. Please go ahead, sir.
Well, thank you, everyone, and for all that are participating in today's call and and for your interest in oncolytics development. We continue to be passionate about improving cancer treatment options for patients, and we're taking the necessary steps to bring Pella to patients by working with our regulators, our clinical collaborators, and the investigators running our studies. We really look forward to our next opportunity to provide another update on our progress and sharing our plans for the rest of the year and into 2025. I'll end our prepared remarks by wishing everyone a great evening. Thanks very much.
Thank you. This concludes our conference for today. Thank you all for participating. You may now disconnect your lines.