Oncolytics Biotech Inc. (ONC) Earnings Call Transcript & Summary

We'll now actually move to the second half of our meeting. Anyone who wishes to submit a question can do so for the general Q&A via the TSX Trust platform. I'll also note that various remarks made during this portion of the call may contain certain forward-looking statements relating to the company's business prospects and the development and commercialization of pelareorep or pela, as we will refer to it, including statements regarding the company's focus, strategy and objectives, the company's belief as to the potential and mode of action of pela as a cancer therapeutic, the design, aims and anticipated benefits of the company's current pending clinical trials and the anticipated timing of the release of additional data, the company's plans and expectations regarding a potential registrational study, the company's business development plans and strategies 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 as to future results, such expectations or beliefs are expressed in good faith and are believed to have a reasonable basis, but there can be no assurance that the statement of expectation or belief that 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 law. I will now pass the call to Matt. Matt, please go ahead.

Thank you, Kirk. I'm pleased to welcome Pat Andrews to our first AGM as a member of the Oncolytics Board of Directors. Pat has an impressive track record in biotech sector and has already helped shape our thinking on pela's path to registration as we continue to engage with current clinical collaborators and potential biopharma partners. Under her watch, she has helped companies complete multiple Phase [ III ] trials, expanded clinical pipelines, prepared commercial launches for novel therapeutics and struck licensing arrangements with major biopharma companies. We look forward to her valued insight and the experience as we evolve in a late-stage oncology [ company ]. As we did last year for our AGM, this meeting is not being held on the same day as our first quarter earnings call. Since we've just provided everyone with an update on that call, we intend to keep remarks made on this call brief. If you'd like to revisit our first quarter and the considerable progress we have made, I encourage you to listen to the replay of the earnings call, reported -- posted on our website, which can be found under Investors. Oncolytics is making substantial strides towards becoming a late-stage oncology company with multiple registration-enabled trials, specifically metastatic HR+/HER2- breast cancer and pancreatic cancer currently being planned. In addition, we expanded enrollment in the anal cancer cohort of GOBLET study as the addition of fewer than 20 patients could solidify the efficacy signal we've seen to date and make the case to move to a registration-enabling study. One news item that I'd like to discuss in more detail today is how we are expected to expeditiously advance the pancreatic cancer treatment regimen [ pela ], atezolizumab, gemcitabine and nab-paclitaxel through our newly announced relationship with GCAR, with a global coalition for [ downward ] research. This novel program can accelerate registrational timelines and provide substantial cost savings compared to traditional Phase III trials. This opportunity came to us because of the Pancreatic Cancer Action Network, or PanCAN, and their decision to form an alliance with GCAR to leverage features of the Precision Promise program to test novel pancreatic cancer therapy regimens and improve treatment for patients. As with Precision Promise, there was a thorough vetting process to [ pela ] selected for inclusion in this novel trial, including multiple presentations to key opinion leaders who are considered among the top experts in the field of pancreatic cancer research. Thanks to these relationships and the exciting data generated by [ pela ], we are working with GCAR to finalize the master protocol design that is expected to generate licensure-enabled data for the combination of pela, atezolizumab, gemcitabine and nab paclitaxel. Another recent pancreatic cancer program topic worth highlighting is the German regulatory and ethics approval on the new cohort of the GOBLET featuring [ pela ] and modified FOLFIRINOX with and without atezolizumab. For a bit of background, modified FOLFIRINOX and GEM/nab paclitaxel are the 2 most frequently utilized treatment for pancreatic cancer. As I mentioned previously, the study with GCAR will feature pela, atezo, gemcitabine and nab paclitaxel, the same treatment regimen as cohort 1 of GOBLET study, which has shown impressive data to date, including a near [ tripling ] of objective response rate compared to just GEM and nab paclitaxel. The new GOBLET cohort focuses on the modified FOLFIRINOX backbone. Therefore, we will be evaluating [ pela ] in the 2 most commonly used treatment for pancreatic cancer. If this pela-based combination shows a similar or better improvement over historical [ control ] trials, there's a meaningful opportunity to improve pancreatic cancer patient care and move the modified FOLFIRINOX combination to a registration-enabling trial as well. The treatment paradigm for pancreatic cancer has not changed for decades, so we're very excited about our ability to be impactful in this difficult-to-treat indication. Finally, we are preparing for a meeting with the FDA this quarter to discuss plans for a registration-enabled breast cancer study for pela combined with paclitaxel compared to paclitaxel alone. We now have 2 randomized Phase II studies showing a meaningful benefit for pela combined with paclitaxel compared to paclitaxel monotherapy. The IND 213 study showed a near doubling in median overall survival in metastatic HR+/HER2- metastatic breast cancer patients receiving pela plus paclitaxel. While the BRACELET-1 overall survival data is expected to be reported in the second half of this year, we've shown a near tripling of the overall response rate, a 50% improvement in median progression-free survival and a hazard ratio of 0.29 with plea plus paclitaxel compared to paclitaxel alone. We've also shown pela benefit in the AWARE-1 breast cancer study, which demonstrated its mechanism of action, its ability to remodel the tumor microenvironment and expand tumor-infiltrating lymphocyte populations. We believe this robust data package makes a compelling case for a clear registration path for pela in breast cancer, and we look forward to aligning with the FDA on the optimal path forward. Before beginning our Q&A session, we're often asked about the expected timing of a biopharma partnership. We can't predict the timing of a partnership like this. However, I can share that we have ongoing discussions with critical parties such as our clinical collaborators. We have also regulated discussions with potential partners with whom we do not currently have a formal relationship. As we report more data, including overall survival from the BRACELET-1 study later this year, we expect these conversations to continue to be informative and will provide updates to our stakeholders as frequently as we can. I can share with you that we have a new Head of Business Development, who is expected to start working with us in a few weeks and will likely [ formally ] introduce them on our second quarter financial results call in August. Now I always try to take the opportunity like this to publicly thank the employees of Oncolytics, the patients involved in our studies and the various collaborators that have enabled us to reach the best [indiscernible] coming to lead the oncology company. With critical data readouts expected this year, interactions with the FDA and the registration-enabled studies being planned, I've never been so enthusiastic about the prospects for pela and this company. We forged new relationships with groups like GCAR to help accelerate pela the registration path, and we continue to have meaningful discussions with potential biopharma partners. The dedication to improving treatments for cancer patients motivates us every day, and we're thankful to our shareholders who also maintain this enthusiasm and optimism for the future of our company. Your support is much appreciated.

Next, we'll begin with Q&A session, where I'll be joined by Kirk, our Chief Financial Officer; Tom Heineman, our place President -- our Chief Medical Officer, Tom Heineman; our Vice President of Product Development, Allison Hagerman, and our Vice President of Clinical Operations, Amy Levin. Kirk, please go ahead and begin reading questions from the queue.

Okay. Matt, we have a number of questions around BRACELET and the overall survival data in the analysis. Just maybe could you touch on when we might think we'll see the survival data coming from BRACELET and what your thoughts are in terms of expectations?

I'm actually going to let Dr. Heineman answer that question. Tom, would you feel free to jump in?

Sure, Matt. So we expect that the overall survival results from the BRACELET study will be available and reported publicly later this year. It's -- the data from this arm has not been reported, I mean, for this -- for overall survival has not been reported so far because these data continue to evolve as we continue to follow patients for survival in the BRACELET study. But we -- as I said, we do expect that those results to be reported towards the end of this year.

Okay. Thanks, Tom. So we have a few questions just on the FDA interaction that's expected this quarter. Can -- the questions really center around what's our expectations. And what are we expecting to hear from the FDA? Tom, do you want to...

Tom to take that one as well?

Sure. Yes. So we will be meeting with the FDA later this quarter. And the -- we've met with the FDA in the past and they've given valuable advice on the path forward for pelareorep in breast cancer. At this meeting, we will continue that discussion in light of some developments and modifications we've made in our thinking based on both the previous FDA guidance and on the evolving standard of care in breast cancer patients, in particular, the availability and efficacy of the new antibody-drug conjugate therapies. I think that the meeting that we will have with the FDA in the near future will help us to align on the best path forward and provide us with clear guidance on the next study of pelareorep in breast cancer patients so that we can move forward confidently with the continued development.

And then a final group of questions just center around the news that we put out this morning with GCAR and the collaboration agreement we signed with this -- with them. Maybe just a synopsis of the -- what to expect with GCAR. And this question is around timing.

I'll take the first part of this, and I'll have Tom jump in. So as we announced last August, we had initially gone into a collaboration with PanCAN for their Precision Promise initiative for pancreatic cancer, which is an adaptive trial design, subsequently found out they were in the process of engaging in the collaboration with GCAR. For that collaboration to move forward, though, GCAR basically was starting from scratch and basically taking that Precision Promise study and refiling it with the agency. So as part of that, we went back to the Selection Committee, which was a very highly vetted process of talking to key international KOLs and academics across the country for selection to this. And we're very proud to say that we are the first new agent to be selected for evaluation in that program. We also now have a seat at the table because they are refiling the Precision Promise protocol. We anticipate it to operationally be nearly exactly the same with some refinements to the study. Every time you work on a protocol, you find something that can be improved and modified. And certainly, GCAR has taken a lead with that. What they're telling us and what we believe is they will have discussions with the agency this summer, and we'll be looking at site initiation and activation of the study H2 of this year, hopefully with first patient on late this year, early next. So we're very excited about how aggressively they've been able to move this forward. That being said, we're still collaborating with PanCAN. Cohort 5 of GOBLETS, looking at modified FOLFIRINOX with and without atezolizumab, is being funded by PanCAN with a mind to identify whether this drug combination is as active as what we saw with GEM/nab-paclitaxel. If it is, then there's a recommendation to move forward into the Precision Promise Phase III, again, with a different backbone. So it really allows us to, I think, address all pancreatic cancer patients by studying and utilizing the 2 most common backbones. Tom, did you have anything to add? Was I reasonably accurate?

Yes. No, I think you covered it. I think an important point to emphasize is that the path forward with GCAR and the gemcitabine, nab-paclitaxel combination and the complementary path forward with the FOLFIRINOX arm of the GOBLET study are really synergistic. And as Matt suggested, give us the opportunity to ultimately provide a treatment that will benefit the large majority of patients with metastatic pancreatic cancer.

Okay. We also have a question with respect to CAR Ts. Any updates on the progress with respect to our CAR T program?

There's a lot going on behind the scenes there, but a lot of it is not terribly exciting for the generalist. Where we're at is we continue to work with Professor Richard Vile at Mayo. We've also signed a number of collaborative agreements with industry partners to look at moving this forward. To move this into the clinic, there's a lot of CMC, or [ chemistry ] manufacturing control, work that has to be done, especially. So how we're using the CAR Ts is we're using pela as a signal to allow CAR Ts to activate or to engage in and migrate to solid tumor, something that they don't normally do. So pela becomes an important signal to allow these CAR Ts entry into the solid tumor microenvironment. To do this, Dr. Vile demonstrated that binding the virus to CAR T cells prior to administration enable them to do this. And by a quirk of nature, it allowed them to be reboosted by the addition of the virus at week 4 to 6 as well as making them dual specific. So in addition to the customized CAR T receptor, these new CAR Ts would actually develop novel antiviral receptors as well. So the chance of escape is much less. What we're doing behind the scenes to enable clinical studies to commence is looking at the stability of the [ pheresis ] product that the frozen CAR Ts with the virus, how long that's stable for, how we're best able to ship it, very much logistical questions. You'll see some of this show up in some publications that we're working on, but it's very sort of industry-specific because it's really looking at the stability program that would enable a clinical program to move forward. What's exciting about this, though, is it should work for all CAR Ts in terms of solid tumors. So we do have multiple collaborations that we've engaged with various third parties, basically doing confirmatory studies and helping us with the CMC issues.

We have another question concerning GOBLET and our anal cancer expanded cohort. Is there an update on that particular cohort? Can you comment on the no-chemo component of the cohort? And any update on enrollment?

Matt, would you like me to take that one?

I was hoping you would, Tom.

Yes, sure. So yes, so the anal carcinoma cohort has been expanded. Enrollment is ongoing into the expansion. Part of that cohort, as was mentioned, we'll be enrolling an additional -- fewer than 20 additional evaluable patients to complete that cohort. We are in the process of engaging additional study sites to enhance enrollment into that cohort. And with regard to the no-chemo part of the question, in the preliminary data that we presented, have shown a very promising signal in this population of second line or later anal carcinoma cancer patients with just a combination of the checkpoint inhibitor and the pela. And we know that checkpoint inhibitors provide only a very modest benefit on their own. So the fact that we're seeing a promising signal with the addition of pela to the checkpoint inhibitor is a very encouraging sign, and we look forward to the data from the whole study, including the expanded enrollment when they're available.

Okay. That is the end of the questions. Thank you for joining us on our AGM. I look forward to updating everyone on our upcoming FDA meeting to discuss our breast cancer program and the progress of our other programs throughout the year. Wishing you all a pleasant afternoon and evening.

Ladies and gentlemen, this concludes today's presentation. Thank you once again for your participation. You may now disconnect.