Oncolytics Biotech Inc. Price & Performance (ONCY)

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 believed to have reasonable basis, but there can be no assurance that these statements, 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. Umklant does not undertake any obligation to update these forward looking statements except as required by applicable laws. Joining me this morning to discuss our recent accomplishments in addition what we're looking forward to in 2025 Chairman of EncloDx Board of Directors and Interim CEO, Wayne Pisano Chief Medical Officer, Doctor. Tom Heinemann Chief Financial Officer, Kirk Look and Vice President of Business Development, Christophe DeGual. To get started, I'd like to hand it to Wayne, who will provide us with an introduction and overview. Wayne?

Thanks, John. And thanks everyone for joining our twenty twenty four year end conference call. First, I'd like to reiterate my and the entire team's best wishes for Doctor.

Matt Coffey, as he focuses full time on his recovery. Many of you know that Matt is a co founder of the company and he has a passion for improving the lives of cancer patients So this is not a decision that was taken lightly. Matt's knowledge and expertise on TELARIO REP and immuno oncology is impressive. He will always be a strong advocate of Tullareorep and we anticipate that he will support Oncolytics an advisory role later this year. We are actively searching for Chief Executive Officer to lead the company's advancement of our novel therapeutic agent [indiscernible] or PELA as we refer to it. We believe the opportunity for PELA is very compelling as we see the potential for an accelerated approval pathway in HR positive HR2 negative metastatic breast cancer. And our exciting work in gastrointestinal tumors continues to garner attention from collaborators like GCAR and PANKAN in addition to key opinion leaders in the field. I'll leave it to Tom to discuss our clinical data in more detail but I'd like to highlight that in 2024, we generated final data in the Bracelet-one breast cancer study that not only met, but exceeded our expectations. We also furthered our work in GI cancers with the ongoing goblet study.

Initial safety and efficacy data in both pancreatic and anal cancers are positive. After Tom, Chris Dweck will provide us with an overview of our business development progress, and Kirk will discuss our financials. I'd like to remind everyone that on our last call, Christophe provided a detailed analysis of the breast cancer market. Even with the introduction of the ADCs, breast cancer remains an unmet medical need for many patients. We estimate that as many as fifty five thousand breast cancer patients would benefit from pelareorep. The efficacy data generated in both breast and gastrointestinal cancer trials demonstrate the potential of ColorReal Rep hard to treat and very diverse tumor types. We remain focused on advancing the development of pelo reo rep for cancer patients and value generation for our shareholders. I'll now turn it over to Tom discuss our clinical program updates. Tom? Thanks, Wayne. The recent impactful GI data that Wayne mentioned were presented in late January at the ASCO GI Conference. From goblet Cohort four, which investigates PELLA and the checkpoint inhibitor atezolizumab in relapsed anal cancer we reported a thirty three percent objective response rate from the 12 evaluable patients including a complete response that lasted more than fifteen months.

In addition, we reported translational data from this cohort showing the expansion of new and pre existing tumor infiltrating lymphocytes clones in the blood of patients who responded to treatment with pelagirap combined with etegelizumab. [indiscernible] We also saw the up regulation of multiple cytokines in these patients including CXCL9, ten and eleven, as well as PD L1 and interferon gamma. These results from patients with relapsed anal cancer support pellet's immunologic mechanism of action as previously defined in other cancers. Specifically, they demonstrate PELA's ability to enhance antitumor T cell responses and its complementary effect of making tumors visible to the immune system. In addition, these findings provide evidence of PELOS' ability to synergize with checkpoint inhibitors and cancer We have begun enrollment into Stage two of this CYMOND-two stage study, which will provide data from an additional 18 patients. We believe the confirmation of the efficacy signal from these patients would provide a strong foundation for a subsequent registrational trial in anal cancer. We At ASCO GIA this past January, we also presented safety results from goblet cohort five, In this cohort, patients with metastatic pancreatic cancer are being treated with PELA combined with modified Fulferonox either with or without atezolizumab in two treatment arms No safety signals were observed during the safety run-in period and both an independent data safety monitoring board and the German regulatory authorities have approved the cohort to continue to full enrollment. [indiscernible] We are now working towards achieving the next enrollment milestone completion of enrollment into stage one of the CYMON2 stage cohort which consists of a total of 30 evaluable patients.

We expect to review and report the initial efficacy results from this cohort by the end of the year. [indiscernible] Note that this cohort is funded by a $5,000,000 grant from the Pancreatic Cancer Action Network or PANCIM through their Therapeutic Accelerator Award based on compelling prior pancreatic cancer results including from cohort one of the goblet study in which patients treated with PELA combination therapy showed an objective response rate more than double historical results. While our GI cancer studies have provided results most recently, our top priority remains breast cancer specifically metastatic HR positive HER2 negative breast cancer in which PELA has previously demonstrated a marked statistically significant near doubling of median overall survival in the IND-two 13 study. In light of this exciting result, we conducted the Bracelet-one study to confirm the robust efficacy signal observed in IND-two 13 and to extend the evaluation of pellet to patients who had previously received CDK4 inhibitors which are now part of the standard treatment regimen for patients with advanced or metastatic HR positive HER2 negative breast cancer. This past fall, the final efficacy results from the BRAZO-one study became available and they once again pointed to a clinically meaningful benefit for patients treated with PELA based combination therapy to those treated with chemotherapy alone.

In fact, all efficacy measures favored patients in the PELLA combination therapy arm compared to those in the chemotherapy alone arm.

These included median progression free survival median overall survival, two year survival rate, and confirmed objective response rate. With these results, we have now observed a substantial efficacy signal from two randomized trials that enrolled over one hundred patients We currently are planning to move directly to a large Phase two study of approximately 180 HR positive HER2 negative advanced or metastatic breast cancer patients that we anticipate will support an accelerated approval file submission In this study, patients will be randomized to receive either PELA plus paclitaxel or control therapy of paclitaxel alone. The primary endpoint is expected to be reached within two years of the start of patient enrollment. The planning for this study is ongoing and we aim to initiate the study in the second half of this year. In conclusion, the clinical data we have generated continue to exceed our expectations provide extremely strong support for continued clinical development and provide clear path towards registration in breast, pancreatic and anal cancer. [indiscernible] all difficult to treat cancers with high unmet needs. Now, I'll turn the call over to Christophe, who will provide an update on our ongoing business development activities and collaborations. Christophe? Thanks, Todd. I'm happy to be here with you today to provide the latest update on our ongoing business development conversations.

Since our last earnings call, we've continued to communicate to potential biopharma partners the substantial clinical benefit PELA has demonstrated across multiple heart disease indications. However, breast cancer is our highest priority. This is because we have data showing patents benefiting two randomized breast cancer studies that exceed one hundred patients. Also, after discussion with regulators and key opinion leaders, we know where PELA should be positioned in the ever evolving breast cancer treatment paradigm. As for the clinical benefit and the final BRLATE-one data we reported this past fall, HELLA combined with paclitaxel showed a greater than twelve month estimated advantage over paclitaxel monotherapy. However, as Tom mentioned, we also saw meaningful benefit in objective response rates PFS and twenty four months overall survival. Our expected positioning of PELA in the treatment paradigm is for it to follow hormonal treatment like endocrine therapy, CDK-four sixty inhibitors, and targeted therapy, an antibody drug conjugate like ERNRT. However, some patients may not be eligible for or cannot tolerate ADCs. So once a patient is eligible for chemotherapy, PELA would be a natural fit as our data with paclitaxel shows a robust benefit of a paclitaxel monotherapy. [indiscernible] As I discussed in great detail on our previous call, this is where we anticipate there will be 55,000 addressable breast cancer patients in The U. S. By 2027, and the potential for $2,400,000,000 in annual sales across The U. S. And major European markets by 20033.

Another important aspect of our BD conversation centers around where we will take Pega next on the regulatory pathway. After multiple discussions with key opinion leaders as statistician, we have designed a registration enabling breast cancer study that could generate a PFS endpoint within two years of the start of patient enrollment and be eligible for an accelerated approval file submission. [indiscernible] We believe this is reasonable because a PFS benefit we would aim to achieve achieve is four point three months but the breastfed benefit was five point seven months. In our meetings, this is an aspect of our strategy that seems to be well understood and one that has already been used by other companies. Including the approval of iBurns for Pfizer and ERNA2 for Daiichi. [indiscernible] in future meetings, we will also layer in the most recent development that we presented at ASCO GI from our promising gastrointestinal opportunity. At this conversation progress, we'll be sure to keep you updated.

We're in the fortunate position to have a compelling data in three indications: breast, pancreatic and anal cancers. These three indications demonstrate the broad potential for pelareorab to help a large number of patients and provide a commercial opportunity that is appealing to potential biopharma partners. In the GI space, GECOR and PAN CAN remain our valued collaborators. We're excited that Goblet CORT V funded by PanCAN is continuing to progress as planned and is now ready for full enrollment given the DSMB and PEI sign offs. As a reminder, Pancam provided Oncolytics with a $5,000,000 grant to fully fund COLD V after an extensive vetting process and meeting with multiple pancreatic key opinion leaders. As a highly regarded organization solely focused on pancreatic cancer, their vote of confidence is in PERA's potential give us confidence in the strategy to continue evaluation in this indication.

Ancillary and continued interest in PEDA is helping us to provide a more complete picture of PEDA's potential in this extremely difficult to treat type of cancer. This is due to the fact that the treatment regimen is scored is evaluating treatment with a different chemotherapy that we have used in the past. Modified for TRADOX. This is one of the two most commonly administered to metastatic pancreatic cancer patients the other being gabstitamine and nabacitaxel. The combination of PELA plus gabstitabine nafaxitaxel and atezolizumab showed a sixty two percent objective response rate well above the usual twenty twenty five response rate that would be expected in a similar patient population. In turn, the data led to the relationship with PANCAN as well as a fast track designation from the FDA and the opportunity to collaborate with GECOR. We continue to engage with GCAR to finalize a master protocol for initiating a registration enabling study could eventually lead to regulatory approval for for the pelagemsitabine, napacitaxel and atezolizumab combination. We look forward to sharing additional enrollment plan updates with you later this year. Next, I'll now turn the presentation over Kirk for a review of our financials. Kirk?

Thanks, Christophe. Good morning, everyone. I'll now discuss our financial results for the fourth quarter and full year 2024. Which will be provided in Canadian dollars unless otherwise noted. A full summary of our financial results can be found the Investors section of our website under Filings and Reports, in the press release issued earlier this morning. Throughout 2024, we remained cautious with our As of 12/31/2024, the company reported $15,900,000 in cash and cash equivalents. Net cash used in operating activities for 2024 totaled $27,000,000 compared to $28,400,000 [indiscernible] reflecting non cash working capital changes partially offset by higher net operating activities in 2024. Now general and administrative expenses for the fourth quarter of twenty twenty four were $3,900,000 compared with $4,200,000 for the fourth quarter of twenty twenty three. The decrease was mainly attributed to lower personnel related along with lower cash annual short term incentive awards. The decrease was partially offset by by higher share based compensation expense. Research and development expenses for the fourth quarter of twenty twenty four were $4,600,000 compared to $4,700,000 for the fourth quarter of twenty twenty three. The decrease was due to lower personnel related expenses, related to lower cash annual short term incentive awards mainly offset by higher clinical trial expenses and share based payment compensation expense.

Net loss for the fourth quarter of twenty twenty four was $8,000,000 compared to a net loss of $3,900,000 for the fourth quarter of twenty twenty three. The basic and diluted loss per share was $0.1 in the fourth quarter of twenty twenty four We compared to a basic and diluted loss per share of $0.05 in the fourth quarter of twenty twenty three. For the full year 2024, net loss totaled $31,700,000 compared to $27,800,000 2023. Or $41 per share on a basic and fully diluted basis. As we look forward to 2025, we are confident in the vast potential that Pella holds for improving patient outcomes. We are making progress as shown by the recent data on pancreatic and anal cancers announced at ASCO GI we are dedicated to advancing PELA as effectively and efficiently as possible. Now before we wrap up today's call, like to thank everyone who continues to support our efforts. We from patients, providers and caregivers to our dedicated employees and most importantly our steadfast shareholders. On behalf of the entire management team at Oncolytics, thank you again for taking the time to join us today. Now, I would like to open the call up for Q and A. Operator?

Thank And your first question comes from the line of Michael Freeman with Raymond James. Please go ahead.

Hey, good morning, Kirk, Wayne, Tom, Kristoff, John.

Congratulations on closing out a strong year 2024 and looking like an action packed 2025. So getting excited for this. I guess one question I have is as you get closer to launching the registration enabling study in metastatic breast, I'm wondering how you're thinking about the total cost of that trial? And I know you did provide some sort of detail around timing. But if you could provide as much color on launch timing and initial readout timing as you can, that'd be terrific.

Sure. I can take that.

So currently, we are working at getting the study registration, pardon me, enrollment ready.

And so what that means is we more or less finalized the protocol we'll be approaching the regulator just as a normal course. Activity. In the meantime, we're working with dead identified sites through feasibility and working with their process to get them on board And then once we once we have that sites identified and ready to be put on board, we'll look to to bring them online and then we'll start and then we'll be in a position to enroll We're targeting to be in that position as things progress, it will probably be later half of the year now. Once enrollment starts, it's expected to be an eighteen month enrollment period. With a six month maturity data maturity to get to PFS readout. In the interim, we're looking at putting in place a futility analysis and we have to finalize that assessment But our expectations right now is a futility analysis will take about fourteen months from the first patient enrolled to get to that point and then we can have the futility readout.

Okay. Great. And then any sharper estimations on total costs?

We're working through that. Michael, I think it's premature to to speak to that in any great detail. But as we understand our sites and and enrollment their enrollment rates, etcetera, we'll be able to have more color on that.

Got you. Okay. Thank you. One more question. I've been noticing more news from oncolytic virus developers in the landscape. And I wonder if you're seeing increasing evidence that there's a bit of a Oncolytics virus renaissance going on. And are you seeing increased interest from pharma as a result? Like I point specifically to CG Oncology, they're able to raise about $2,000,000 at the end of last year on good data. And that's a live virus. Curious how you're seeing things curious your perspective on all this.

Christophe, do you want to speak to that as to what you've heard on your end? And I can follow-up and if others want to jump in, they can.

No, happy to answer that. Yes, you're exactly right. I mean, you're talking about CG oncology. We also I don't know, you may have seen also Candor where who's done a raise at the end of last year. So we definitely see more activities in that field. I think that's very beneficial for us because let's remember that we have significant advantage being injected instead of I mean IV injection and not an intratumoral. And that the intratumoral has been sometimes a little complicated for for big pharma companies that don't they're not really interested in that. So we as I mentioned during the call, I think we continue to have a conversation with potential partners and we've seen that the fact how we position PELA in breast cancer the multiple signal breast cancer, obviously having very strong data, but also the strong signal we've seen in other indication pancreatic and anal, resonating very well with potential companies.

Kirk, do you want to add anything to that?

Yes. And what we're noticing on kind of discussions and presentations with investors is again more interest in the in the OB space. We're seeing more dedicated clinicians, science experts from those investors sitting down and talking to us and and walking through our data and our plan. And there's been some comments on from their standpoint just seeing some white space opportunities to generate return. For them. And so their focus is on that. They see some of them are seeing this as a real opportunity. So that in combination with what's going on in the industry, I think there's some pretty big and important data readouts coming from our competitors that will be important. To help those investors continue looking at the space. And we've seen a real shift in that So we're excited to hopefully be part of that.

Excellent. Yes, good riding tight situation. I hope And if I could shoehorn one last one in. I wonder the pancreatic front, and your alignment with GCAR, I understand that you're working together to submit get that master protocol. Together. First, is this will this be the first trial launched from the GCAR platform? And I recognize that it takes some time for this organization to unload and get together a master protocol. But I wonder if there is if there's any way that this trial can be can be accelerated to launch?

John, can you speak to it? Yes, I can speak to that, but we have been working, as Kirk mentioned, very actively with GCAR to finalize a licensure enabling study protocol. The next step would be, as would be typical in this sort of situation to be to go to the regulators and and get the FDA's thoughts and move on from there. And so it's really maybe a little early for us to say anything very specific about the timing. Until we talk to the FDA. But I can say with regard to accelerating it, that like we are working very actively with GCAR and so we're moving things forward.

With them at the greatest possible pace.

Okay.

Thank you very much. I look forward to seeing all your activity this year. I'll pass it on.

Your next question comes from the line of Patrick Trupio with C. Wainwright. Please go ahead.

Good morning everyone. Thank you for taking our questions. Luis here for Patrick.

Congratulations on the [indiscernible] presentations. We are curious to know what your thoughts are around the positioning, the commercial positioning of of PELA given that ADCs seem to have shown and continue to show positive results I think the same patient population. So you are probably going to focus on the patients that did not respond or are not eligible. As you said, or for this kind of therapy. Is there any other population that you could target that regarding the ADCs and you think that there's a a potential also for combination, not just as a sequential treatment approach, but a combination with HER2A and other AUCs? Thank you.

Okay. So Tom here, I can start there and then if Christophe or others want to jump in, they can. But you're right. We do want to target patients who are ineligible for or who cannot tolerate ADCs but in actuality, the largest population we expect to target will be patients who receive ADC therapy and then progress on ADC therapy. Which is going to be a very large population The ADCs have been extremely successful drugs and have benefited a lot of patients.

But they are not cures, right? And so once a patient takes an ADC after at the appropriate time in their treatment, path, they will eventually progress on that therapy and will at that point need the best possible treatment options. And so we think that we would be may very well provide an alternative there that would be very attractive. Right? And then I'm sorry, what was the second part of your question, please?

We were wondering if there's any potential for combination with any of these therapies? Yes, sorry. So pelarerep in general has proven itself to be an agent that can potentiate the activity of other therapies including chemotherapy and immunotherapies. I think it's a very logical thing to consider. In the future. It's not our immediate path for a variety of reasons now, but I think the appropriate time in the future, combination therapy with ADCs and other agents certainly be something worth considering.

Great. Thank you. And yes, this is Christophe. I can add a little color on the more on the numbers of patients for you. As you may recall, we discussed in our total addressable patient population And when you look at that, it's mostly for patients who would have been on ERN02. And would have initially responded and then would relapse, which is as you you look at ERN-two, I mean your average PFS is ten to eleven months. So we know that this patient at some point in time, we need a will need another better treatment another treatment. So when we build our forecast of that totals more than $2,000,000,000 That considers fifty five thousand patients annually in The U. S. And then we take a very conservative approach with 15% to 20% market share in this population. So that's where we believe there's a significant market opportunity. [indiscernible] The follow-up question Thank you. That was very helpful.

Great.

Thank you.

And I'm showing no further questions at this time. I would like to turn it back to Kirk Loeb for closing remarks.

Thanks to everybody who took the time to join our earnings call this morning. This is going to be an exciting year for PELLA and Oncolytics with additional data readouts.

Expected in the planning of registration enabling studies that can move PELA closer to regulatory approval. Thanks again for your support. We will have more updates as soon as we can.

Wishing everyone a wonderful day. Thanks very much.

Thank you, presenters. And ladies and gentlemen, this concludes today's conference call. Thank you all for participating. You may now disconnect.