Good afternoon, and welcome to Oncolytics Biotech's Q3 2024 Conference Call. All participants are 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 Jon Patton, Director of Investor Relations and Communication. Please go ahead.
Thank you, Operator, and thank you all for joining us. After remarks from company management, we will open the call for Q&A. As a reminder, the remarks made during this call contain certain forward-looking statements relating to the company's business prospects and the development and commercialization of Pelareorep, including statements regarding the company's mission, strategy, and milestones, the company's belief as to the potential and mechanism of action of Pelareorep as a cancer therapeutic, our potential registrational opportunities for Pelareorep and our plans and strategies related thereto, our plan to continue enrollment in GOBLET Cohort 5, our ongoing business development initiatives, 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 Oncolytics expresses an expectation or belief that the future results, such expectations or beliefs, are expressed in good faith and are believed to have 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 by regulatory agencies, and those other factors detailed in the company's filings with SEDAR and the SEC.
Oncolytics does not undertake any obligation to update these forward-looking statements except as required by applicable laws. Now, I'm pleased to introduce the members of our management team who are joining me to discuss the important progress we made during the Q3 . These are Chair of Oncolytics Board of Directors and Interim CEO Wayne Pisano, Chief Medical Officer Dr. Tom Heinemann, Chief Financial Officer Kirk Look, and Vice President of Business Development Christophe Degois. Wayne will start our conversation this morning, so I'll hand it off to him. Wayne.
Thank you, Jon. Good morning. Also, thanks to everyone who's joining our call today, especially because we've had several meaningful news events since our last update. Following my brief introduction, Tom will provide a recap of the BRACELET-1 data and our plans for a clinical trial designed to support the accelerated approval of Pelareorep in metastatic breast cancer. He will also expand upon our plans for Pelareorep in gastrointestinal cancers. Christophe will discuss our large addressable market opportunities and partnership efforts. Kirk will review the financials. And finally, we will end by taking your questions. In the Q3 of 2024, we reached a critical milestone in our development of Pelareorep, or pelAR, as we often call it, our leading immunotherapeutic agent.
The BRACELET-1 breast cancer study reported its final data, and the combination of pelareorep plus paclitaxel showed substantial improvement compared to paclitaxel monotherapy in critical metrics like progression-free survival, overall survival, and 24-month overall survival rate. Progression-free survival and the 24-month overall survival rate nearly doubled, while overall survival showed an approximate 14-month benefit. We believe these data provide us the opportunity to significantly impact the lives of patients with HR-positive, HER2-negative metastatic breast cancer, and we believe the next appropriate step is the registration-enabling study utilizing BRACELET-1 outcomes as the basis for an accelerated approval development path. Now, before Tom provides a more comprehensive update, I would also like to highlight that we are continuing enrollment in the safety run-in phase of GOBLET Cohort 5 in newly diagnosed patients with metastatic pancreatic ductal adenocarcinoma, supported by the Pancreatic Cancer Action Network.
Additionally, we continue to work with GCAR on finalizing the master protocol and seeking FDA feedback for the registration-enabling study in pancreatic cancer. With the potential for two registrational studies ahead, we believe 2025 will be an exciting year for pelareorep and for Oncolytics. Now, I'd like to turn the call over to Tom to provide a more detailed update. Tom.
Thank you, Wayne. Just to quickly refresh anyone who hasn't heard our story for a while or is new to what we're doing, pelareorep is an intravenously delivered immunotherapeutic that acts systemically. It introduces double-stranded RNA into the tumor, which promotes an inflammatory response that makes the tumor visible to the immune system. At the same time, it stimulates anti-tumor cellular immune responses that can attack the now visible tumor. Our main priorities are to advance our planned registrational studies in breast and pancreatic cancer, so that is where we will focus our discussion today. Starting with our breast cancer program, we recently shared efficacy results from the BRACELET-1 study, which exceeded our expectations across the board, including both progression-free survival, PFS, and overall survival, OS. The median PFS nearly doubled from 6.4 months in the control arm to 12.1 months in the pelareorep arm.
Similarly, while median OS was 18.2 months in the control arm, it could not even be calculated in the pelareorep because more than half the patients were still alive at the end of the study. Nonetheless, using the conservative assumption that all the pelareorep patients would have passed away at the time of their next clinic visit, the median OS would have been 32.1 months, well more than a year longer than the control patients. Perhaps even more telling, the proportion of patients who lived two years or longer nearly doubled from 33% in the control arm to 64% in the pelareorep arm. It's important to note that the patient populations were well-balanced across the study groups with no substantial differences that would be expected to bias results in favor of pelareorep.
Safety results from the BRACELET-1 study were in line with pelareorep's well-understood and favorable safety profile based on more than 1,100 treated patients. The next question is where we go from here. After discussions with key opinion leaders, our biopharma collaborators, and the FDA, we have identified an approach that can generate primary endpoint results within two years of the start of patient enrollment. Accordingly, our next planned breast cancer study is anticipated to be a registration-enabling large phase 2 study of around 180 HR-positive, HER2-negative metastatic breast cancer patients. We would use progression-free survival as a primary endpoint and would power the study to achieve a phase 3 level of success if the expected clinical benefit is achieved. If pelareorep-based therapy demonstrates a progression-free survival benefit comparable to that seen in BRACELET-1, we anticipate seeking licensure potentially through the accelerated approval pathway.
This approach has been used to achieve the initial approvals of other breast cancer treatments, including Pfizer's Ibrance, Daiichi Sankyo's Enhertu. We believe this is a cost-effective and efficient strategy for the development of pelareorep in breast cancer. I would now like to move to the GOBLET study and our opportunity in gastrointestinal cancers. So far, we have evaluated pelareorep-based therapies in first-line metastatic pancreatic ductal adenocarcinoma, or PDAC, third-line metastatic colorectal cancer, and second-line or later anal cancer. Despite the difficulty of treating these specific cancers, pelareorep-based combination therapy met the initial predefined efficacy success criteria for each of these indications. Our highest priority in GI cancers is pancreatic cancer. We've seen exciting efficacy signals in previous studies, and the objective response rate we reported in the pancreatic cancer cohort of the GOBLET study was more than double historical objective response rates.
The strength of these results attracted the attention of multiple potential partners. One of these collaborators is the Global Coalition for Adaptive Research, or GCAR, which specializes in the design and conduct of cost-effective, innovative adaptive clinical trials intended to support licensure. We are currently collaborating with GCAR to develop an adaptive registration-enabling study to evaluate pelareorep-based combination therapy in metastatic PDAC, and we expect to seek, with GCAR, FDA guidance on the study design. We look forward to continuing our collaboration with GCAR on this exciting opportunity, and we will provide an update as this program advances. As a complement to our work with GCAR, we also received a $5 million grant from the Pancreatic Cancer Action Network, also known as PanCAN, to evaluate a different pelareorep-based combination therapy in PDAC.
Historically, the two most common standards of care in metastatic pancreatic cancer are the chemotherapy regimens of gemcitabine and paclitaxel, or modified FOLFIRINOX. The gemcitabine and paclitaxel regimen is the focus of our work with GCAR, while the PanCAN grant is funding the evaluation of pelareorep combined with modified FOLFIRINOX. This is an attractive opportunity because if pelareorep-based therapy demonstrates benefit when combined with both commonly used chemotherapy regimens, it may lead to improved therapeutic options for nearly all metastatic pancreatic cancer patients.
Earlier this year, we announced the dosing of the first patient in the new GOBLET cohort evaluating pelareorep combined with modified FOLFIRINOX. Enrollment into this cohort of the GOBLET study is ongoing, and we will provide additional updates when they become available. Should the combination of pelareorep and modified FOLFIRINOX produce a positive outcome, it would result in another registrational opportunity for pelareorep in this challenging indication.
Before I turn the call over to Christophe to expand on our business development efforts as well as our most recent commercial assessments, I would like to briefly summarize our immediate priorities. First, we plan to pursue an accelerated approval pathway for pelareorep in HR-positive, HER2-negative metastatic breast cancer through a large registration-enabling study that compares paclitaxel plus pelareorep to paclitaxel alone. Since we've already demonstrated pelareorep's clinical benefit in two prior randomized studies, we are confident in this approach. Secondly, we are working with GCAR to finalize the protocol for the metastatic pancreatic cancer trial evaluating pelareorep, gemcitabine, nab-paclitaxel, and atezolizumab, and we will seek guidance from the FDA on this approach, which we believe will open another registrational pathway for pelareorep.
And finally, we continue to enroll patients into the GOBLET study cohort evaluating pelareorep combined with modified FOLFIRINOX, which is in newly diagnosed pancreatic cancer patients. Our conviction in pelareorep's broad therapeutic benefits grows stronger with each positive data set, as does our belief in pelareorep's potential to improve the lives of cancer patients. With that, I will turn the call over to Christophe to discuss pelareorep's market opportunity, our ongoing collaborations, and future partnership opportunities. Christophe.
Thanks, Tom. Since joining Oncolytics, I've focused on facilitating business development opportunities as well as working to articulate a broad opportunity we have with pelareorep to potential strategic industry partners. We continue to have conversations with our current collaborators, Pfizer and Roche, in addition to potential biopharma partners.
With the announcement of the final data from BRACELET-1, including a 5.7 months progression-free survival benefit and nearly 14 months overall survival benefit, I anticipate we'll be able to have an enhanced discussion about pelareorep going forward, as this is an asset that is clearly ready to move to registration or setting. The number of potential partners could be interested in the progress we're making and in our plans for the future. We just completed a robust analysis of the HR-positive, HER2-negative metastatic breast cancer population, and I'm encouraged by the potential pelareorep we have in this indication.
Using the assumption that pelareorep could be ready for an accelerated approval in 2027, we anticipate an addressable population of around 55,000 patients in the US at that time. We arrive at these numbers by factoring in patients who would have progressed on endocrine therapy and who are ineligible for, not responsive to, or progressed on Enhertu, which is an antibody conjugate that's becoming part of the breast cancer treatment paradigm.
If we then project sales going forward to the US and Europe, assuming a 15% to 20% market penetration by the year 2033, we see the potential for $2.4 billion in annual sales for US plus EU5. This would create a meaningful breast cancer drug franchise to just about any biopharma partners, and that is what we're offering in our discussion going forward, a multi-billion dollar potential drug with the potential for accelerated approval in a few years.
While we are obviously very excited about the breast cancer data and opportunity, pelareorep has shown exciting efficacy in multiple cancer indications. The pancreatic cancer data has been reported and is very compelling as well. In the Q2 , we entered into a collaboration with GCAR, and last year received funding from PanCAN via the Therapeutic Accelerator Award.
Both of these strategic relationships provide external validation of the potential of pelareorep-based combination therapy. GCAR selected the combination of pelareorep, gemcitabine, nab-paclitaxel, and atezolizumab for investigation in the inaugural pancreatic cancer program after a thorough vetting process, which included meetings with key opinion leaders and multiple committees. We're working with them to finalize the master protocol and have GCAR submit to the FDA for guidance. Importantly, the GCAR Alliance will provide access to trial sites, rapid patient enrollment, and control arm drug supply.
PanCAN is a nonprofit organization dedicated to finding pancreatic cancer in a comprehensive way by advancing scientific research, building community, sharing knowledge, and advocating for patients. PanCAN Therapeutic Accelerator grant is funding cohort five of the GOBLET study, which is pelareorep plus modified FOLFIRINOX with and without atezolizumab.
As Tom mentioned earlier, modified FOLFIRINOX is the other chemotherapy backbone that is most often used besides gemcitabine plus nab-paclitaxel. So a meaningful response with the FOLFIRINOX combination would create significant opportunity to improve the treatment outcomes for a large number of patients. With that, I'll bring on Kirk to cover our Q3 2024 financial highlights. Kirk.
Thanks, Christophe, and good morning, everyone. I'd like to discuss our financial results for the Q3 of 2024, which will be provided in Canadian dollars unless otherwise noted. A full summary of our financial results can be found on the investor section of our website under filings and reports or in the press release issued earlier this morning. As we start to ramp up our efforts to put pelareorep on the path to registration, we continue to be efficient with our cash resources and keep our critical milestones in mind.
As of September 30th, 2024, the company reported CAD 19.6 million in cash and cash equivalents. Net cash used in operating activities for the nine months ended September 30th, 2024, was CAD 19.1 million compared to CAD 22.3 million for the nine months ended 30 September 2023.
The decrease reflects non-cash working capital changes, partly offset by higher net operating activities in 2024. Our general and administrative expenses for the Q3 of 2024 were $3.1 million compared to $5.2 million for the Q3 of 2023. The decrease was primarily due to lower investor relations activities and transaction costs that were part of our 2023 public offering. Research and development expenses for the Q3 of 2024 were $6.8 million compared to $5.8 million for the Q3 of 2023.
The increase was primarily due to higher manufacturing expenses and clinical trial expenses. Increased manufacturing expenses were related to completing a cGMP production run in the quarter. Increased clinical trial expenses were associated with our GCAR collaboration, the BRACELET-1 study closeout costs, and the clinical data management of legacy studies.
This increase was partly offset by lower GOBLET study costs as we focus on enrolling cohort five, which is supported by the PanCAN grant. The net loss for the Q3 of 2024 was C$9.5 million compared to a net loss of C$9.9 million for the Q3 of 2023. The basic and diluted loss per share was C$0.12 in the Q3 of 2024 compared to a basic and diluted loss per share of C$0.14 in the Q3 of 2023.
Now, we are very excited to move pelareorep further along the path to registration, and we are looking at multiple upcoming milestones. We are moving forward with our registration-enabling study in HR-positive, HER2-negative metastatic breast cancer based on the clinical benefits observed in IND-213, BRACELET-1, in addition to the feedback we received from the FDA.
Our collaboration with GCAR is continuing to progress, and we are nearing the finalization of the master protocol. Cohort five of the GOBLET study, the combination of pelareorep and modified FOLFIRINOX with and without atezolizumab, continues to enroll, and we expect safety data in early 2025, followed by efficacy data in later next year. We are also looking for updated efficacy data from cohort four of GOBLET next year, that is the cohort evaluating pelareorep and atezolizumab in second line or later anal cancer.
So we always try to end our calls by expressing our gratitude to the people who are instrumental in helping us continue our mission of giving cancer patients the opportunity to live longer, better lives. This includes the entire Oncolytics team, our investors, our patients, and their families. Now, I would like to open the call for Q&A. Operator.
Ladies and gentlemen, we will now begin the question and answer session. Should you have a question, please press star, followed by the one on your touch-tone phone. You will hear a prompt that your hand has been raised. Should you wish to decline from the polling process, please press star, followed by the two. If you're using a speakerphone, please lift your handset before pressing any keys. First question comes from a line of Soumit Roy with Jones Trading. Please go ahead.
Soumit, you may be on mute.
Hi, good morning, everyone. Sorry, I was on mute. Congratulations on all the progress and wanted to check on the upcoming San Antonio breast cancer update. Should we expect any closer data cut, or what kind of details should we expect there?
Yeah. Hi, Soumit. Tom Heinemann here, Chief Medical Officer. The data that we presented in this call are, in fact, the final results. Because of the timing of the meeting, we will not have any update at San Antonio, but the results presented are, in fact, the final results, so there is no more updated cut expected.
Got it. And a quick one on the HER2-negative status is, could you remind us they were, I'd say, two and below, or?
When this study was started, the antibody-drug conjugates were not on the market, and they were not being used, right? So there was no reason to test specifically the HER2 status. All of the patients in this study fell into the classic characterization, however, of HER2-low. So they were all two or lower according to the standard definition.
Okay. Thank you again for taking the questions.
Sure.
Next question comes from Louise Chen with Cantor. Please go ahead.
Hi, good morning, everyone. Thank you for taking our questions. First, on your breast cancer registration-enabling study, can you provide additional color on the potential to achieve accelerated approval? How early were you able to achieve this, or do we have to wait until the trial completion for regulatory action? I do have a follow-up. Thank you.
Okay. I'll start, Tom Heinemann, again. The path for regulatory approval and accelerated approval is based on our prior feedback with the FDA and on precedent, right? We think that the study, as designed, will provide a clinically meaningful benefit. If it does provide a clinically meaningful benefit comparable or even anywhere close to what we saw in the BRACELET-1 study, that would result in a statistical level of a p-value of less than 0.05, okay? In other words, with that study, we would hit all the main points that the FDA is looking for when they consider an approval. One, we would have a clinically meaningful benefit. Two, we would have a highly statistically significant study.
Three, if it performs as it has in all our previous studies, we would have a solid safety profile, which are the three main things the FDA is looking for, okay? So the FDA, of course, will never tell you in advance that they will approve anything before they see the data. But if this study performs as we expect it to, we would hit on all the points that we think would be compelling for the FDA to support a regulatory approval, following in the precedent set by many drugs, but including such drugs as Ibrance and Enhertu. With regard to the timing, perhaps I can hand that off to Kirk to discuss the timing explicitly, if you don't mind, Kirk.
Yeah. In terms of timing, once we can get the study up and running and enrolling, we expect enrollment to happen over an 18-month period. Data maturity is expected to be six months after the last patient is on. We would expect to submit the data, of course. We expect to be in a filing position after that point in time.
Great. Thank you. My follow-up question is, on your first upcoming major milestone, which is finalizing the master protocol for your adaptive registration-enabling trial, given this is for first-line PDAC patients, we're wondering how quickly we're able to complete patient enrollment? Thank you.
Well, so we need to finalize the protocol, as we mentioned. It will need to be discussed with the FDA. In other words, there are some upstream steps. Once that study starts enrolling, we would have to map out the timelines precisely based on the parameters of the study at that time. But we expect it to enroll quickly because this is not a rare disease. This is an unfortunately relatively common cancer. And we would be expecting to work with all of, well, or many of the best, highest recruiting potential sites in the U.S. and maybe even elsewhere. So while I hesitate to put a precise timeline on it, we expect this study to enroll very efficiently. And Kirk, maybe you'd like to expand on that. I don't know.
No, no. I think that's exactly right.
Okay. Great. That's helpful. Thank you so much.
The next question comes from Michael Freeman with Raymond James. Please go ahead.
Hey, good morning, Wayne, Kirk, Tom, Christophe. First of all, congratulations on the sensational metastatic breast data. It's truly impressive. So my question is, on the back of this overall survival data, I wonder, perhaps Christophe, if you could describe your partnering and business development approach and algorithm as you have this powerful data in hand. And if you could describe, maybe just summarize, how progress is going. And for instance, have you seen an accumulation of pharmas in your data room? And then I'll have a follow-up after this.
Yes, sure. This is Christophe Degois. Yes. I mean, before I joined the company last year, we had, when we presented the interim data, the PFS data, we had some interest from pharma companies, but obviously, they wanted to see the final data. As explained during this call, we got this data very recently, so we are getting our ducks in a row and starting to re-engage pharma companies. Obviously, we've been talking, as mentioned before, we've been talking to our current partners, but we're also expanding to other companies.
I think the end of the year is coming, and J.P. Morgan, I think we're really now preparing for a big outreach, a large outreach. That will be with your typical big pharma partners that are interested in the solid tumor market, but also potentially European or Asian companies for more regional partnership. We haven't decided yet on the best options. We're looking at different options right now. So obviously, in the coming months, I think we'll be very active.
Okay. Excellent. Yeah, that's helpful. I guess when you think about a partnership, how would you contemplate structuring that sort of partnering deal or sort of business development deal? The type of outreach you've just described, how do you expect the structure of an ultimate deal might be?
Again, this is a little early, but we have definitely, if you look at what we've done so far, we've had the capacity to run the phase II trial that Tom described in breast cancer, but there are also other opportunities, as we explained. Obviously, pancreatic cancer, even in breast, there may be other opportunities, early-on opportunities, so I think our objective is going to bring a partner that's going to help us accelerate the development of the drug in breast, I mean, metastatic breast cancer, but potentially also in the other indication. We are a fairly small company. Our focus right now is definitely on bringing pelareorep approval for breast cancer, but we cannot neglect the other opportunities in other solid tumors.
So for us, I think the ideal partner is somebody who's going to get committed to help us accelerate that and also prepare for the launch of the drugs. If we get accelerated approval, we want someone who is going to help, especially on the commercial side, preparing the market for the drug. And that's where a big pharma or large biotech can really bring value.
Absolutely. And just very quickly, one more. What pricing are you using as you size these markets, as you just did very well?
Yeah, that's a very good question. We've made some assumptions on that. And the pricing we're using is a pricing similar to nivo with a slight premium since we'll be coming post-nivo for most of the patients. And we've looked at the pricing of nivo in the US and outside the US. As you can imagine, the pricing outside the US is slightly different.
Okay. Thank you very much. I'll pass it on now.
Thank you.
There are no further questions, so go ahead. Just continue.
That concludes our call today. Again, I'd like to thank everyone who took the time to join us this morning and learn more about our recent progress in BRACELET-1 and our plans for registration and syndication. I hope everyone has a wonderful day. Again, thanks very much. Have a great day. Bye.