Good morning, everyone. My name is Carvey Leung, a biopharma associate here at Cantor. Today, we have Oncolytics with us. Thank you for joining for a Fireside Chat with us at our annual healthcare conference. Before we start, can you tell us a little bit about your background and your role at the company?
Yeah, for sure. So first off, to Carvey and Louise, thank you very much for the invitation. We really appreciate the opportunity to be here today at Cantor and present and have this Fireside Chat. So my name is Kirk Look. I'm the Chief Financial Officer with the company. I've been with the company for over 20 years now, and so I've seen it, you know, you know, pretty much from the very beginning through to today, where we've... You know, we're excited to report survival data coming out of our BRACELET study, which we've been mentioning and talking about for the last, you know, over a year now. We put out some progression-free survival data at ASCO back in 2023, and had to let the survival data mature and...
Today, we were able to report on that, so that was pretty exciting. I'm a CPA by background, and like I said, I've been working with the company for over 20 years.
Okay. Yeah, yeah, good to be here. Tom Heineman, I'm the Chief Medical Officer at Oncolytics. I've been with the company about four years now. Spent my career in academia, big pharma, small biotech, background in medicine and molecular biology, and also very happy to be here and have the opportunity to speak about our new results.
Fantastic.
Mm-hmm.
To begin, what is your company's strategic vision, and where is the company now? Where are you seeing the company will be in the next five to ten years?
Yeah, so our vision is to give cancer patients some more time. And, you know, we think that we have through the development of pelareorep, our immunotherapeutic agent, we think we have a real opportunity to do this in two indications, metastatic breast cancer, as well as pancreatic cancer. And so, you know, today, you know, I'll turn it over to Tom here pretty shortly to touch on the data that we announced.
Mm
... this morning. But, you know, we think we have two real legitimate pathways to approval, both, one in metastatic breast cancer and one in pancreatic cancer. And so we're excited to, you know, to develop pela and achieve this strategic objective. We sit here today with these two concepts, and, you know, in the next three to five years, we're going to put those into place.
We're, you know, going to embark on an accelerated approval concept in breast cancer, where we think that, based on the data that we'll talk about later, in terms of progression-free survival and overall survival with breast cancer, we think we have a strong opportunity to seek accelerated approval with a large phase 2 study, and Tom will talk about that as well. On the pancreatic cancer side, again, with, you know, just some really impressive data coming out of our GOBLET study, and we're leveraging that data along with some foundational data that we've been working on for the last, you know, almost ten years now.
We're gonna take that data and work with a group called the GCAR, the Global Coalition for Adaptive Research, to put into place a phase 3 program that will seek full approval, you know, if the data is successful. So three to five years from now, we'll be well on our way, enrolling patients into both of those studies. And we've set it up such that, you know, within five years, we're quite confident that, you know, as long as the data cooperates, that we'll be submitting for approval in either one or both of those indications. So maybe before, you know, we get further on, you know, I wanted to turn it over to Tom, and he can just talk about the breast cancer data that we put out this morning.
We're pretty excited about this, the survival data, of course.
Yeah, sure. I'd be very happy to talk about the impressive data that we were able to announce this morning. So as Kirk mentioned, the BRACELET study has been an ongoing study of ours for the past few years. We've reported very solid tumor response data and progression-free survival data a year or so ago at ASCO, and now we have the overall survival data and the final progression-free survival data. So in the BRACELET study, we were evaluating patients who had inoperable breast cancer, HR-positive, HER2-negative breast cancer, and these patients were treated with either pelareorep combination therapy or with a chemotherapy control. Okay, and we're very very pleased to be able to announce that the patients who were treated with the pelareorep combination therapy had substantially better clinical outcomes than those patients treated with the chemotherapy control.
Specifically, in the chemotherapy-alone group, the median overall survival was 18.2 months, which is about what you'd expect for this patient population. In the pelareorep for the patients who received the pelareorep combination therapy, the median overall survival was actually not reached at the end of the study because more than half the patients were still alive. If, however, you took a very conservative approach to estimate what the median overall survival might be, for example, if you assumed that all the patients in that arm of the study were to die at their next follow-up visit, the median overall survival would be over 32 months, okay? So I say, even with a very conservative estimate, the pelareorep combination therapy provided well over a year of clinical benefit on survival. Now, in accordance with those results, we also can report the 2-year survival rate-...
for the different arms of the study. So in the chemotherapy control arm, the two-year survival rate, the proportion of patients living two years or more, was 33%. In the pelareorep combination therapy arm, it was 64%, so a near doubling of the median, excuse me, near doubling of the survival rate at two years. And then also just to mention, we do have the updated progression-free survival data from that study, and this favorable trend is also represented in those results. So in the control arm, the median PFS was 6.4 months. In the pelareorep combination therapy arm, it was 12.1 months, 5.7-month benefit, so also a highly positive result and consistent with the earlier preliminary PFS results and the tumor response results that were reported at ASCO.
So, and obviously, we're very pleased to see that the pelareorep therapy, base therapy, has provided such strong clinical benefit.
And can you also highlight the safety from this final update?
Yeah, so the safety data from this study were actually analyzed and presented in their final form at the ASCO presentation. No new safety data, no new safety issues, no new safety data were actually resulted from this final analysis. What we can say is that in patients treated with pelareorep, we see the typical types of adverse events that we have seen in many studies, in many patients treated with pelareorep. So just to one step backwards, we've treated over 1,100 patients in different cancer indications with pelareorep-based therapy, so we have a very solid understanding of the safety profile. The types of things that you see are, I guess, would be typically categorized as flu-like symptoms, so you get patients who will have fevers, occasionally chills, fatigue, myalgia, and so forth.
These are typically mild to moderate at most. Rarely do these adverse events reach the level of being considered, you know, Grade 3, that is to say, severe.
Oncology is a-
Mm-hmm
... evolving space.
Mm-hmm.
So how do you think this treatment will fit into a treatment paradigm?
Yeah, so I can answer that. So the patients that we're focusing on are HR-positive, HER2-negative patients who have which is the biggest subset, genetic subset of breast cancer patients, and these are patients who have inoperable disease. So patients with this type of breast cancer are usually treated with hormonal therapy, one or two lines of hormonal therapy, and maybe some targeted therapies, if appropriate. And then, historically, they would, at that point, receive traditional chemotherapy. Okay. Now, with the advent of the antibody-drug conjugates, the most best-known one being in HER2, for example, the treatment paradigm is evolving a little bit, and so patients now and in the future will be receiving antibody-drug conjugates much more frequently following the hormonal therapy. Okay, so that's great, and then, and these drugs have been proven to be very effective.
However, they are not cures, right? And so there remains a strong medical need for at least three groups of patients, patients who are inappropriate for antibody-drug conjugate therapy, for whatever reason, patients who cannot tolerate it, because some patients simply don't tolerate it, and also patients who receive antibody-drug conjugate therapy and then progress. And so we want to be the treatment of choice following or in any of those circumstances to provide better options than are currently available.
Great.
Mm-hmm.
And, um-
Mm-hmm
... given you have five point seven, roughly six months-
Mm
... of benefits.
Mm-hmm
... what are the next steps for this breast cancer program?
Yeah, so I think the next step will be for us to, as Kirk mentioned, to move forward to a registration-enabling study.
Mm-hmm.
We, and there are a lot of different ways you can do that, but I think the most efficient, appropriate path that we can find is through a large phase two study with a focus on obtaining an accelerated approval. This is the same path, by the way, I might add, that was used for the initial approvals of such successful oncology drugs as Enhertu, for example, but also Ibrance and others. Okay, we would envision that study would be a relatively straightforward two-arm study of pelareorep-based combination therapy compared to a chemotherapy control, and we would target the patient populations I just mentioned, most particularly patients who have failed antibody-drug conjugate therapy.
This study would be powered to support an accelerated approval if we get anywhere close to the clinical benefit that we've recently observed in the BRACELET study.
How's your communication been with the FDA? Have they given you, kind of directions of what the study should be? What's the latest-
Mm
... with the discussions with them?
Yeah, so over the years, we've had a number of different discussions with the FDA, most recently in end of May this year, and we did propose this plan and this study to the FDA, and they gave us some very helpful guidance, as always. They commented on and helped, and they provided guidance that will help us to refine in certain detailed ways the study population. They endorsed PFS as a primary endpoint.
And very importantly, they provided some guidance on what they consider to be a clinically meaningful effect size, for example, for progression-free survival, which is very helpful to us in powering the study to make sure that we have enough statistical power to lock down the treatment effect that would be needed to support an approval.
Got it. Great.
Okay.
So now we're switching over-
Mm-hmm
... to pancreatic.
Yeah.
Maybe you can talk about, you know, the populations you are targeting. You know, how does your product address unmet needs in pancreatic cancer?
Sure. So pancreatic cancer, as you know, is one of the deadliest cancers out there, in part because patients are much more often than not diagnosed only after the disease has become inoperable, right? So there's a huge medical need in patients with metastatic pancreatic cancer, okay? The treatment approaches to pancreatic cancer have not changed in a substantially for most patients in the past, you know, 10, 15 years almost at this point. So what, what we are, what we are observing, what we have observed. I mean, obviously, our target population then is to improve outcomes in this, in this, in this patient population for which, you know, for whom there's a huge medical need, right?
What we've observed in our most recent GOBLET study, and also as Kirk alluded to in prior studies in pancreatic cancer, that pelareorep-based therapy, that is, say, pelareorep combined with chemotherapy, and in some cases, also with checkpoint inhibitors, has provided very strong evidence of clinical benefit in these patients. Okay, so we want to aim our next efforts on expanding those data, confirming them in an appropriately powered study, and moving forward towards licensure.
My understanding is that this GOBLET study is funded from a $5 million award from PanCAN. Maybe you can talk about the relationship with PanCAN and details of it.
Yeah, would you-
Yeah, for sure. So PanCAN's the Pancreatic Cancer Action Network, and, you know, we've been working with them for a little while now. They're interested in wanting to find ways to get treatments for pancreatic cancer through the clinical development and approved. And in one area that they, you know, that they've been quite successful in is just the whole grant arena, where they're providing grants to companies like Oncolytics to start earlier stage studies with you know with potential treatments that make sense to them, and to push them forward into a phase three and an approval environment. And so we one of the areas that we wanted to investigate in pancreatic cancer was the other standard of care treatment paradigm.
So the-
Mm-hmm
... you know, we, all of our data, not all, a lot of our data is with gem, nab-paclitaxel, but there's also modified FOLFIRINOX. What we proposed to PanCAN and submitted a grant for was to investigate safety and efficacy signal with pelareorep in combination with modified FOLFIRINOX. We were successful and received an award, a $5 million award, connected to their process. We're using those funds to add an additional cohort to our GOBLET platform study. We've started that this year. We started the safety run-in with that cohort, where we're looking at pancreatic cancer in combination with modified FOLFIRINOX, pelareorep, and the atezolizumab
Mm-hmm
... as well. And so our hope is that we'll, you know, see... We won't see any additional toxicity, and that the safety run-in will be positive. We'll get the green light. We expect to continue enrollment late this year, early in 2025, and then we'll fully enroll the cohort in the GOBLET study, utilizing the grant to understand what the efficacy signal is, and from there, we'll make decisions as to how we might be able to capture an approval.
Mm-hmm.
Fantastic. Since we're on the topic of pancreatic cancer, you also have a collaboration with GCAR. What was the selection process like? What data have you presented that caught the attention of GCAR?
Yeah, I can comment on that. So, GCAR, that's, as Kirk mentioned earlier, the Global Coalition for Adaptive Research, is a nonprofit organization that has led research initiatives in a number of cancer therapeutic areas, right? And they're very interested in expanding their scope into pancreatic cancer. I mean, they have a lot of internal expertise, but they've also acquired a very strong network of external investigators, key opinion leaders, really top people in the field to advise them and work with them.
So in the process of working with them and discussing the initial steps with them, we did go through a very detailed and somewhat lengthy vetting process with them, where we presented the data from our pancreatic program in particular, the GOBLET data, but also our earlier pancreatic cancer data. I think that they and their scientific advisors and medical advisors were all impressed by the potential of pelareorep to provide a benefit for pancreatic cancer patients, especially in this setting where so little activity of any consequence happened for a long time. And so I think looking at our data and discussing with us the potential, I think they are very enthusiastic about moving forward with the pelareorep-based combination therapies for this population.
Great. So you mentioned this study is adaptive.
Mm-hmm.
So maybe you can talk a little bit about the advantage of having adaptive study versus a traditional study.
Sure. So GCAR, their one of their specialties is to design with the appropriate external expertise studies with these innovative designs. And we are in active discussions with them to work out some of the details of the design for the study that we want to do with them, right? So I can't give you every detail of how that's gonna play out. But historically, with them, they have, they have found ways to design studies that are that utilize the patient population available to its maximum potential, right? So these tend to be efficient studies, maybe a little smaller on the average than a traditional registrational study, because they do use these adaptive approaches.
So the advantages are that these are, as I say, very efficient, they're cost-effective, they're, they put fewer patients at risk, they reach their endpoints quicker, right? And so, as we work through these details with them, we would hope that we would benefit from all of those advantages. And also, as I mentioned before, they're very well connected to a cohort of really, you know, strong, top-tier investigators in the U.S. and elsewhere in the world, and so that another advantage is that we would have access to these, you know, top-line investigators and investigational sites.
Great.
Mm-hmm.
I'm gonna take a pause here and see if there are any questions from the audience. Sarah?
Just off that note, sorry, Is there historically, for GCAR, how have they reached their endpoints faster, and, like, how do they make it more efficient? Sorry, I might have just, like, missed that or misunderstood.
For example, I mean, again, we are still in discussions with them about the details of our study, but for example, they might do things where they would design a platform study where they would have control arms would be used across different investigational arms. So they'd have one or more control arms, and then they might have two, three, four, however many investigational arms. And so they could use patients from the control arm across different studies so that each of the investigational arms wouldn't need to enroll their own control arms. That's one approach.
Okay.
And then there are statistical approaches that they use to make, you know, to embed efficiencies in the study as well.
Okay, I see.
Sure, yeah.
Yes, Louise.
Okay.
Yeah.
So I wanted to ask you-
Mm-hmm.
Congratulations on your BRACELET data. I'm actually pretty surprised the stock went up on such stellar data. But I do wanna ask you what it would cost to move into registration-enabling studies?
Yeah, so the large phase 2 that we're gonna move forward with, we've modeled it to cost around $30 million. So that's our expectation right now. It's going to... From the point of first patient on, it's about an 18-month enrollment rate. So we would expect to be fully enrolled, and then the value of the progression-free survival endpoint that opens up the accelerated approval opportunity is we would see that readout in our... Again, our modeling is looking at about a 24-month period for that readout, of which then if we're successful, and we meet the criteria that we set the statistical analysis plan up for, we would then be in a position shortly afterwards to file a submission for accelerated approval.
Okay, and then you said in your press release that you're looking for sources of funding in order to move this program forward. So do you have the cash on hand or need to work on this? Do you have an ATM in place, or how are you thinking about all this? Is there any non-dilutive source-
Mm-hmm
... of funding that you're looking at?
Yeah, so we have $24 million, which was what we reported at the end of the quarter, or the end of Q2, which takes us into and through into Q2 of 2025. That isn't sufficient to run the study, so we are looking for to fund it. We'll be looking at the equity capital markets, of course, you know, whether it's through an ATM facility or, you know, a traditional financing approach. And then on top of that, we are active in the, in the, you know, pharma space, looking, you know, looking at alternative solutions there as well, engaging pharma.
You know, challenge with that is it's, you know, slow-going, and, you know, you can't control timing as much, but we'll, you know, we'll look to do that and bring kind of all those three solutions together to get this funded.
Okay, and then where do you see your product fitting into the treatment paradigm? There's a lot of treatments for breast cancer, so how do you-
Yeah.
Yeah, I can address that, yeah. So, patients who have these inoperable forms of breast cancer, right, they'll go through a progression of different treatments, and there's a lot of work and a lot of new things coming along upstream of where we're playing, right? But once they get down to a certain point, then they may receive, for example, the newer antibody-drug conjugates. But once they progress on those treatments, which, you know, as you know, are not cures, they will progress on those treatments eventually. Their options now are very limited. I mean, there are things coming along, but nothing that is really proven to be, you know, the option at that point. So many patients will just go back to traditional chemotherapy, right?
... and once they're on traditional chemotherapy, well, then that's where the BRACELET study comes in, right? And if the results we see in BRACELET are replicated or anywhere close to that in this patient population, then that would be a huge advantage over what's currently available, okay? One thing that sometimes people don't or misunderstand or might is that, you know, we are not, at this point in time, planning to compete with the antibody drug conjugates, right? We're not gonna go head-to-head with Enhertu, for example, because that's not where the medical need is. The medical need is in patients who've taken Enhertu, for example, or other antibody drug conjugates, and then either progress or cannot tolerate them, for example, or simply proportion of patients who are simply not appropriate for them. Does that help?
It does.
Yeah, yeah.
And then, Kirk-
Yeah.
Maybe you could size the market opportunity?
Yeah
... in terms of, total-
Yeah
Addressable market or peak sales potential for your company.
Yeah, for sure. So the work that we've done, taking into account the ADCs and Enhertu and our expectations there is, you know, we think in the U.S., we have an addressable patient population of about 55,000 patients. So, you know, taking some reasonably conservative assumptions, you know, that equates to peak sales in 5 years of about $2.4 billion. So it really is a legitimate commercial opportunity, which is what we're, you know, excited about. And again, it can impact those patients that we think will come our way after Enhertu.
Mm-hmm. Wayne?
How about the pancreatic cancer? Can you also touch on that? The sort of addressable patient population, and also where will it fit into that treatment paradigm?
Do you wanna-
Yeah, yeah.
I mean, there's...
So, there's about 60,000 plus or minus new cases of pancreatic cancer in the U.S. every year. The large majority of them, 70%-80% at a minimum, will have metastatic disease, and so will need treatments in that setting, which is where we're playing here. The population of pancreatic cancer patients that we are targeting are these first-line patients, so patients who have newly diagnosed disease or perhaps patients who have had operable disease but then relapse later on. So these are patients who are getting chemotherapy for the first time, and that's where we're, you know, which is gonna be the biggest share of the pancreatic cancer population. Yeah.
As part of GOBLET study, it has a component for anal cancer.
Yeah.
So what kind of data do you have so far? How aggressive are you going after this indication?
Yeah, so the anal carcinoma is a rare disease. We're looking at patients with relapsed disease. These patients have very, very limited, inadequate treatment options at the moment. The data we are seeing in the GOBLET study is still early, and we're but the, but we are seeing in very encouraging tumor responses of, you know, three times or thereabout what would be expected in this population, okay? So we're very encouraged by that. We've expanded enrollment into that study, and we'll get more data, and if these results continue to trend in that direction, we would like to move forward with a registrational study directly.
This being a rare indication, it's very possible that we could conduct a registrational study that would be smaller than typical, maybe even a single-arm study, because the regulatory agencies understand that larger, you know, phase III-type studies in this population may not be doable.
Great.
Yeah.
So before we close, are there any final thoughts that you'd like to share that we haven't discussed?
No, I think, you know, I think we covered, you know, all aspects of our program. You know, we're, again, you know, today was an exciting day for us, just to bring the BRACELET survival data to the market and finally, you know, be able to lay out what our plan is. Our... The confidence that we have in moving this forward, and the confidence that we have in the plan to seek accelerated approval is high. And so now we just need to, you know, we need to deliver on that plan, so we're excited.
Mm-hmm.
Then in behind that, we, you know, we have other opportunities with pancreatic cancer and anal carcinoma, so it's, you know, a lot of, a lot of good things coming our way.
Fantastic. Congrats on the data, and thank you for being here.
Yeah, thank you very much.
Thank you very much.