Q3 2024 Oncolytics Biotech Inc Earnings Call
Speaker Change: Good afternoon and welcome to Oncolytics Biotech's third quarter 2024 conference call.
Speaker Change: All participants are in a listen-only mode. There will be a question and answer session at the end of this call.
Speaker Change: Please be advised that this call is being recorded at the company's request. I would now like to turn the call over to John Patton, Director of Investor Relations and Communication. Please go ahead.
John Patton: Thank you, Operator, and thank you all for joining us. After remarks from Company Management, we will open the call for Q&A.
John Patton: As a reminder, errors and marks made during this call contain certain forward-looking statements relating to the company's business prospects and the development and commercialization of Telluria Rep.
John Patton: including statements regarding the company's mission, strategy, and milestones, the company's belief as to the potential and mechanism of action of Pella Rearep as a cancer therapeutic, our potential registrational opportunities for Pella Rearep, and our plans and strategies related thereto.
John Patton: a 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.
John Patton: These statements are based on management's current expectations and beliefs, and are subject to a number of factors which involve none 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, expectations implied by these forward-looking statements.
John Patton: In any forward-looking statement in which oncologically expresses an expectation or belief that the future results such expectations or beliefs are expressed in good faith may I believe have reasonable basis, but there can be no assurance that the statement or expectation or belief will be achieved.
John Patton: These factors include results of current or pending clinical trials, risks associated with intellectual property protection, financial projections, actions of our regulatory agencies, and those other factors detailed in the company's filings with CDAR and the SEC.
John Patton: Unclaimed 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 third quarter.
John Patton: These are Chair Ivankovic's Board of Directors and Interim CEO Wayne Pisano
John Patton: Chief Medical Officer, Dr. Tom Heineman, Chief Financial Officer, Kirk Look, and Vice President of Business Development, Christophe Degois.
Speaker Change: Wayne will start the conversation this morning, so I'll hand it off to him. Wayne?
Wayne Pisano: Thank you, John. 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.
Wayne Pisano: Following my brief introduction, Tom will provide a recap of the Bracelet-1 data and our plans for a clinical trial design to support the accelerated approval of PelorheaRep and metastatic breast cancer.
Speaker Change: He will also expand upon our plans for tell the real rep and gastrointestinal cancers.
Speaker Change: Christophe will discuss our large addressable market opportunities and partnership efforts.
Speaker Change: Kirk will review the financials, and finally, we will end by taking your questions.
Speaker Change: In the third quarter of 2024, we reached a critical milestone in our development of Pella-RioRep, or Pella as we often call it, our leading immunotherapeutic agent.
Speaker Change: The BRACEFIT-1 breast cancer study reported its final data, and the combination of Pella plus Paclitaxel showed substantial improvement compared to Paclitaxel monotherapy
Speaker Change: in critical metrics like progression-free survival, overall survival, and 24-month overall survival rate.
Speaker Change: Progression-free survival and the 24-month overall survival rate nearly doubled. Overall survival showed an approximate 14-month benefit.
Speaker Change: We believe these data provide us the opportunity to significantly impact the lives of patients with HR-positive, HR-2-negative metastatic breast cancer.
Speaker Change: And we believe the next appropriate step is a registration-enabling study utilizing Bracelet-1 outcomes as the basis for an accelerated approval development path.
Speaker Change: 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.
Speaker Change: Additionally, we continue to work with GCAR on finalizing the master protocol and seeking FDA feedback for the registration-enabling study in pancreatic cancer.
Speaker Change: With the potential for two registrational studies ahead, we believe 2025 will be an exciting year for Pella and for Oncolytics. Now, I'd like to turn the call over to Tom to provide a more detailed update. Tom?
Tom Heineman: 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, Pell is an intravenously delivered immunotherapeutic that acts systemically.
Tom Heineman: 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.
Tom Heineman: 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.
Tom Heineman: Starting with our breast cancer program, we recently shared efficacy results from the BRACELET1 study, which exceeded our expectations across the board, including both progression-free survival, PFS, and overall survival, OS.
Tom Heineman: The median PFS nearly doubled from 6.4 months in the control arm to 12.1 months in the Pella arm.
Tom Heineman: Similarly, while median OS was 18.2 months in the control arm, it could not even be calculated in the Pell arm because more than half the patients were still alive at the end of the study.
Tom Heineman: Nonetheless, using the conservative assumption that all the Pella 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.
Tom Heineman: Perhaps even more telling, the proportion of patients who live two years or longer nearly doubled from 33% in the control arm to 64% in the Pella arm.
Tom Heineman: 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 TELA.
Tom Heineman: Safety results from the brace of one study were in line with TELA's well understood and favorable safety profile based on more than 1,100 treated patients.
The next question is, where do we go from here?
Tom Heineman: After discussions with key opinion leaders, our biopharma collaborators, and the FDA, we have identified an approach.
Tom Heineman: 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 two study of around 180 HR positive, HER2 negative metastatic breast cancer patients.
Tom Heineman: We would use progression-free survival as a primary endpoint and would power the study to achieve a Phase III level of success if the expected clinical benefit is achieved.
Tom Heineman: If Pella-based therapy demonstrates a progression-free survival benefit comparable to that seen in Bracelet 1,
Tom Heineman: 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, Eyebrant's, Daiichi's, and Hercules.
Tom Heineman: We believe this is a cost-effective and efficient strategy for the development of Pella and breast cancer.
Tom Heineman: I would now like to move to the Goblet Study and our opportunity in gastrointestinal cancers.
Tom Heineman: So far, we have evaluated tele-based therapies in first-line metastatic pancreatic ductal adenocarcinoma, or PDAC,
Tom Heineman: third-line metastatic colorectal cancer, and second-line or later, later anal cancer.
Tom Heineman: Despite the difficulty of treating these specific cancers, pellet-based combination therapy
Tom Heineman: 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.
Tom Heineman: And the objective response rate we reported in the pancreatic cancer cohort of the GOBLET study was more than double historical objective response rates.
Tom Heineman: The strength of these results attracted the attention of multiple potential partners.
Tom Heineman: 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.
Tom Heineman: We are currently collaborating with GCAR to develop an adaptive registrational labeling study to evaluate Pella-based combination therapy in metastatic PDAC, and we expect to seek, with GCAR, FDA guidance on the study design.
Tom Heineman: We look forward to continuing our collaboration with GCAR on this exciting opportunity, and we will provide an update as this program advances.
Tom Heineman: 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 pellet-based combination therapy in PDAC.
Tom Heineman: Historically, the two most common standards of care in metastatic pancreatic cancer are the chemotherapy regimens of gemcitabine napaclitaxel or modified fulfirinox.
Tom Heineman: The Gemcitabine NAPAC Litaxil Regimen is the focus of our work with GCAR, while the PAN-CAN grant is funding the evaluation of Pella combined with modified fulfironox.
Tom Heineman: This is an attractive opportunity because if Pella-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.
Tom Heineman: Earlier this year, we announced the dosing of the first patient in the new goblet cohort evaluating Pella combined with modified fulfironox.
Enrollment into this cohort of the Goblet Study is ongoing.
and we will provide additional updates when they become available.
Tom Heineman: Should the combination of Pella and modified fulferinox produce a positive outcome if it resulted in another registrational opportunity for Pella in this challenging indication?
Tom Heineman: 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.
Tom Heineman: First, we plan to pursue an accelerated approval pathway for Pella in HR-positive, HER2-negative metastatic breast cancer through a large registration-enabling study that compares Paclitaxel plus Pella to Paclitaxel alone.
Tom Heineman: Since we've already demonstrated TELUS clinical benefit in two prior randomized studies, we are confident in this approach.
Tom Heineman: Secondly, we are working with GCAR to finalize the protocol for the metastatic pancreatic cancer trial evaluating Pella, gemcitabine, nabpaclitaxel, and atezolizumab.
Tom Heineman: And we will seek guidance from the FDA on this approach, which we believe will open another registrational pathway for Pella.
Tom Heineman: And finally, we continue to enroll patients into the Goblet Study Cohort evaluating PELLA combined with modified full-therodox.
which is a newly diagnosed pancreatic cancer patient.
Tom Heineman: Our conviction in Pella's broad therapeutic benefits grows stronger with each positive data set, as does our belief in Pella's potential to improve the lives of cancer patients.
Speaker Change: With that, I will turn the call over to Christophe to discuss Pella's market opportunity, our ongoing collaborations, and future partnership opportunities. Christophe?
Thanks, Tom.
Christophe Degois: Since joining Oncologics, I've focused on satisfying business development opportunities, as well as working to articulate the broad opportunities we have with Pella to potential strategic industry partners.
Christophe Degois: We continue to have conversations with our current collaborators, Pfizer and Roche, in addition to potential biopharma partners.
Christophe Degois: with the announcement of the final data from bracelet one including a 5.7 seventh month progression-free survival benefit.
Christophe Degois: and nearly 14 months overall survival benefit anticipate we'll be able to have an end discussion about PELA going forward as this is an asset that is clearly ready to move to a registrational setting.
Christophe Degois: They are members of potential partners who could be interested in the progress we are making and in our plans for the future.
Christophe Degois: We just completed a robust analysis of the HR-positive O2-negative metastatic breast cancer population and I'm encouraged by the potential payload may have in this indication.
Christophe Degois: Using the assumption that PELA could be ready for next year's approval in 2027,
Christophe Degois: We anticipate an addressable population of around 55,000 patients in the U.S. at that time.
Christophe Degois: We derive these numbers by factoring in patients who would have progressed on endocrine therapy.
Christophe Degois: and who are ineligible for, not responsive to, or progress on Nr2, which is an antibody conjugate that's becoming part of the breast cancer treatment paradigm.
Christophe Degois: If we then project sales going forward to the U.S. and Europe,
Christophe Degois: Assuming a 15 to 20 percent market penetration by the year 2033, we see the potential for 2.4 billion in annual sales for US plus EU 5.
Christophe Degois: This would create a meaningful breast cancer drug franchise to just about any biopharma partners.
Christophe Degois: And that is what we're offering in our discussion going forward.
Christophe Degois: A multi-billion dollar potential drug with the potential for accelerated approval in a few years.
Christophe Degois: While we are obviously very excited about the breast cancer data and opportunity, data has shown exciting efficacy in multiple cancer indications.
Christophe Degois: The pancreatic cancer data that has been reported is very compelling as well.
Christophe Degois: Both of these strategic relationships provide external validation of the potential of Pella-based combination therapy.
Christophe Degois: GCAR selected the combination of Pellar, Gencitabine, Napalitaxel, 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.
Christophe Degois: We're working with them to finalize the master protocol and have G-Cost submitted to the FDA for guidance.
Christophe Degois: Importantly, the GICA Alliance will provide access to trial sites, rapid patient enrollment, and controlled arm drug supply.
Speaker Change: PanCam is a non-profit organization dedicated to finding pancreatic cancer in a comprehensive way by advancing scientific research, building community, sharing knowledge, and advocating for patients.
Speaker Change: Pan-Cantherapeutic Accelerator Grant is funding Court 5 of the GOBLET study, which is Pellab plus modified fulferinox, with and without atezolizumab.
Speaker Change: As Tom mentioned earlier, modified fulfrenox is the other chemotherapy backbone that is most often used besides gemcitabine plus MAP-Paxitaxel. So a meaningful response with a fulfrenox combination would create significant opportunity to improve the treatment outcomes for a large number of patients.
Speaker Change: With that, I'll bring on Kirk to cover Q3 2024 Financial Highlights.
Thanks, Christophe, and good morning, everyone.
Kirk Look: I'd like to discuss our financial results for the third quarter of 2024, which will be provided in Canadian dollars unless otherwise noted.
Kirk Look: 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 morning.
Kirk Look: As we start to ramp up our efforts to put Pella on the path to registration, we continue to be efficient with our cash resources and keep our critical milestones in mind.
Kirk Look: As of September 30, 2024, the company reported $19.6 million in cash and cash equivalents.
Kirk Look: Net cash used in operating activities for the nine months ended September 30, 2024 was $19.1 million, compared to $22.3 million for the nine months ended September 30, 2023.
Kirk Look: The decrease reflects non-cash working capital changes partly offset by higher net operating activities in 2024.
Kirk Look: The general and administrative expenses for the third quarter of 2024 were $3.1 million compared to $5.2 million for the third quarter of 2023.
Kirk Look: Research and development expenses for the third quarter of 2024 were $6.8 million compared to $5.8 million for the third quarter of 2023.
Kirk Look: The increase was primarily due to higher manufacturing expenses and clinical trial expenses.
Kirk Look: Increased manufacturing expenses were related to completing a CGMP production run in the quarter.
increased clinical trial expenses were associated with our GCAR collaboration.
Kirk Look: Birchland One-Study Closeout Costs, and the Clinical Data Management of Legacy Studies.
Kirk Look: This increase was partly offset by lower goblet study costs as we focus on enrolling cohort 5, which is supported by the Pan-Can grant.
Kirk Look: The net loss for the third quarter of 2024 was $9.5 million compared to the net loss of $9.9 million for the third quarter of 2023.
Kirk Look: The basic and diluted loss per share was $0.12 in the third quarter of 2024 compared to a basic and diluted loss per share of $0.14 in the third quarter of 2023.
Kirk Look: Now, we are very excited to move Pella further along the path to registration, and we are looking at multiple upcoming milestones.
Kirk Look: We are moving forward with our registration-enabling study in HR-positive, HER2-negative metastatic breast cancer based on the clinical benefits observed in IND2 and 3, bracelet 1, in addition to the feedback we received from the FDA.
Kirk Look: Our collaboration with GCAR is continuing to progress, and we are nearing the finalization of the Master Protocol.
Kirk Look: Cohort 5 of the Goblet Study, the combination of Pella and modified falferinox with and without atezolizumab, continues to enroll and we expect safety data in early 2025, followed by efficacy data later next year.
Kirk Look: And 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.
Kirk Look: This includes the entire Oncologics team, our investors, our patients, and their families.
Speaker Change: 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 touchtone phone. You will hear a prompt that your hand has been raised.
Speaker Change: If you are using a speakerphone, please lift your handset before pressing any keys.
Thank you for watching.
Somebody may be on mute.
Speaker Change: Hi, good morning everyone. Sorry I was on mute. Congratulations on all the progress. I 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?
Thank you.
Thanks for coming, Tom Heineman here, Chief Medical Officer.
Speaker Change: The data that we presented in this call are, in fact, the final results.
Speaker Change: 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.
Speaker Change: Got it. And a quick one on the HER2 negative status is, could you remind us they were IHC 2 and below or?
Speaker Change: Well, 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...
Speaker Change: Her too low, so they were all too or lower according to the standard definition.
Thank you again for taking the questions. Sure.
Speaker Change: Next question comes from Louise Chen with Gandor. Please go ahead.
Speaker Change: 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? And I do have a follow-up. Thank you.
Okay, well, I'll start, Tom Heineman again.
So the...
We
Speaker Change: a path for regulatory approval and accelerated approval is based on our prior feedback with the FDA and on precedent, right? And so we think that the study, as designed, will provide
clinically meaningful benefit
Speaker Change: And if it does provide a clinically meaningful benefit comparable or even anywhere close to what we saw in the Bracelet study,
Speaker Change: main points that the FDA is looking for when they consider an approval. So one, we would have a clinically meaningful benefit.
Two, we would have...
Speaker Change: statistical, a highly statistically significant study, and 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.
Speaker Change: 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.
Speaker Change: following in the precedence set by many drugs, but including such drugs as Ibrance and HER2.
Speaker Change: And with regard to the timing, perhaps I can hand that off to Kirk to discuss the timing explicitly, if you don't mind, Kirk.
Kirk Look: 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, and then data maturity is expected to be six months.
Kirk Look: after the last patient's on, and then we would expect to be in a, subject to the data, of course, we expect to be in a filing position after that point in time.
Speaker Change: 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 will you be able to complete patient enrollment? Thank you.
Speaker Change: based on the parameters of the study at that time, but we expect it to enroll quickly because this is a
Speaker Change: This is not a rare disease. This is a, unfortunately, relatively common cancer, and we would be expecting to work with
Speaker Change: are 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 evolve very efficiently. And Kirk, maybe you'd like to expand on that, I don't know.
Nope, no, I think that's exactly right.
Okay.
Great, that's helpful. Thank you so much.
Speaker Change: The next question comes from Michael Freeman with Raymond James. Please go ahead.
Thank you.
Speaker Change: Hey, good morning, Wayne, Kirk, Tom, Christophe. First of all, congratulations on the sensational metastatic breast data. It's truly impressive.
Speaker Change: So, on, my question is, you know, on the back of this...
overall survival data.
Speaker Change: 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, you know, maybe in a, just summarize how
Speaker Change: how progress is going. And for instance, like, have you seen an accumulation of pharma in your data room? And then I'll have a follow-up after this.
Speaker Change: Yes, sure. This is Christophe Degois. Yes, we last year, I mean, before I joined the company last year, we had, you know, 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.
Speaker Change: As explained during this call, we got this data very recently, so we are putting a duck in order and starting to re-engage pharma companies.
Speaker Change: Obviously, you know, we've been talking, as mentioned before, we've been talking to our current partners, but we're also expanding to other companies.
Speaker Change: I think, you know, the end of the year coming and G.P. Morgan, I think we're really now, you know, preparing for a big outreach and a large outreach.
Speaker Change: And that, you know, will be with your typical, you know, big pharma partners that are interested in the solid tumor market, but also, you know, potentially, you know, European or Asian companies for more regional partnership.
Speaker Change: We haven't decided yet, you know, of, you know, 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. Thanks, Wayne.
Speaker Change: Yeah, that's helpful. I guess I guess when you think about a partnership
Speaker Change: How would you contemplate structuring that sort of a 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?
Speaker Change: Again, this is a little early, but, you know, we have definitely, you know, if you look at what we've done so far, we've had the capacity, you know, to run the Phase II trial that Tom described, you know, in breast cancer.
Speaker Change: But there are also, you know, other opportunities, as we explained. Obviously, pancreatic cancer, either in breast, you know, there may be other opportunities, you know, early on opportunities. So, I think our objective is going to bring a partner that is going to help us accelerate the development of the drug.
Speaker Change: in breast, I mean, metastatic breast cancer, but potentially also in the other indication.
Speaker Change: We are, you know, a fairly small company. Our focus right now is definitely, you know, on bringing, you know, Pella
approve, you know, for breast cancer.
Speaker Change: But we cannot neglect the other opportunities in other solid tumors.
Speaker Change: So, for us, I think the ideal partner is somebody who is going to get committed to help us accelerate that and also prepare, you know, for the launch of the drugs. If we get accelerated approval, we want someone who is going to help, you know, especially, you know, on the commercial side, preparing the market for the drug. And that's where, you know, the big pharma or large biotech, you know, can really bring value.
Speaker Change: Absolutely, and just very quickly with one more, what pricing are you using as you size these markets as you just did very well?
Speaker Change: Yeah, that's a very good question. You know, we've made some assumptions on that and the pricing we're using is a pricing similar to EARN-O2 with a slight, you know, premium since, you know, we'll be coming, you know, post-EARN-O2 for most of the patients.
Speaker Change: And we've looked at the pricing of NO2 in the U.S. and outside the U.S. As you can imagine, the pricing outside the U.S. is slightly different.
Thank you.
Okay, thank you very much. I'll pass it on now.
Thank you.
Speaker Change: If there are no further questions, we will go ahead and continue.
Speaker Change: Well, 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 One and our plans for registration and syndication. I hope everyone has a wonderful day. Again, thanks very much. Have a great day. Bye.
Speaker Change: Ladies and gentlemen, this concludes today's conference call. Thank you for your participation. You may now disconnect.