Oncolytics Biotech Inc (ONCY) 2024 Q4 法說會逐字稿

Good morning, and welcome to Oncolytics Biotech's fourth-quarter and full-year 2024 conference call.

(Operator Instructions) Please be advised that this call is being recorded at the company's request.

I would now like to turn the call over to Jon Patton, Director of Investor Relations and Communications.

Please go ahead.

Thank you, operator.

Good morning, everyone, and welcome to Oncolytics fourth-quarter and full-year 2024 earnings call.

As a reminder, various remarks made during this call contain certain forward-looking statements relating to the company's business prospects and the development and commercialization of pelareorep, including statements regarding the company's mission, strategy, and milestones; the company's belief as to the potential and mechanism of action of pelareorep as a cancer therapeutic; our search for a new permanent CEO; our potential registrational opportunities for pelareorep and our plans and strategies related thereto; potential market for pelareorep in breast cancer; our plans to continue enrollment in GOBLET Cohort 5; our ongoing business development initiatives; and other statements related to anticipated developments in the company's business.

These statements are based on management's current expectations and beliefs, and are subject to a number of factors which involve known and unknown risks, delays, uncertainties, and other factors not under the company's control and 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 or expectation or belief will be achieved.

These factors include results of current or pending clinical trials, risks associated with intellectual property protection, financial projections, actions by regulatory agencies, and those other factors detailed in the company's filings with SEDAR and the SEC.

Oncolytics does not undertake any obligation to update these forward-looking statements, except as required by applicable laws.

Joining me this morning to discuss our recent accomplishments in addition to what we're looking forward to in 2025, Chairman of Oncolytics Board of Directors and Interim CEO, Wayne Pisano; Chief Medical Officer, Dr. Tom Heineman; Chief Financial Officer, Kirk Look; and Vice President of Business Development, Christophe Degois.

To get us started, I'd like to hand it to Wayne who will provide us with an introduction and overview.

Wayne?

Thanks, Jon, and thanks, everyone, for joining our 2024 year-end conference call.

First, I'd like to reiterate my and the entire team's best wishes for Dr. 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 pelareorep and immuno-oncology is impressive.

He will always be a strong advocate of pelareorep.

And we anticipate that he will support Oncolytics in an advisory role later this year.

We are actively searching for a Chief Executive Officer to lead the company's advancement of our novel therapeutic agent, pelareorep 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/HER2-negative metastatic breast cancer.

And our exciting work in gastrointestinal tumors continues to garner attention from collaborators like GCAR and PanCAN, 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 outstanding final data in the BRACELET-1 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, Christophe 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 55,000 breast cancer patients would benefit from pelareorep.

The efficacy data generated in both breast and gastrointestinal cancer trials demonstrate the potential of pelareorep in hard-to-treat and very diverse tumor types.

We remain focused on advancing the development of pelareorep for cancer patients and value generation for our shareholders.

I'll now turn it over to Tom to 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 4, which investigates pela and the checkpoint inhibitor atezolizumab in relapsed anal cancer, we reported a 33% objective response rate from the 12 evaluable patients, including a complete response that lasted more than 15 months.

In addition, we reported translational data from this cohort, showing the expansion of new and pre-existing tumor-infiltrating lymphocyte clones in the blood of patients who responded to treatment with pelareorep combined with atezolizumab.

We also saw the upregulation of multiple cytokines in these patients, including CXCL9, 10, and 11, as well as PD-L1 and interferon gamma.

These results from patients with relapsed anal cancer support pela'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 pela's ability to synergize with checkpoint inhibitors in cancers that have historically resisted immune therapies.

We have begun enrollment into Stage 2 of this Simon two-stage, which will provide data from 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.

At ASCO GI this past January, we also presented safety results from GOBLET Cohort 5.

In this cohort, patients with metastatic pancreatic cancer are being treated with pela combined with modified FOLFIRINOX, 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.

We are now working towards achieving the next enrollment milestone, completion of enrollment into Stage 1 of the Simon two-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.

Note that this cohort is funded by a $5 million grant from the Pancreatic Cancer Action Network or PanCAN through their Therapeutic Accelerator Award based on compelling prior pancreatic cancer results, including from Cohort 1 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-213 study.

In light of this exciting result, we conducted the BRACELET-1 study to confirm the robust efficacy signal observed in IND-213 and to extend the evaluation of pela to patients who have previously received CDK4/6 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 BRACELET-1 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 pela combination therapy arm compared to those in the chemotherapy alone.

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 100 patients.

We currently are planning to move directly to a large Phase 2 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 controlled 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 cancers, 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, Tom.

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 hard-to-treat indications.

However, breast cancer is our highest priority.

This is because we have data showing pela's benefit in two randomized breast cancer studies that exceed 100 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 BRACELET-1 data reported this past fall, pela combined with paclitaxel showed a greater-than-12-month estimated advantage of paclitaxel monotherapy.

However, as Tom mentioned, we also saw meaningful benefit in objective response rate, PFS, and 24 months overall survival.

Our expected positioning of pela in the treatment paradigm is going to follow a run-on treatment like endocrine therapy, CDK4/6 inhibitors, and targeted therapy, and antibody drug conjugate like ENHERTU.

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 paclitaxel monotherapy.

As I discussed in great detail on our previous call, this is why we anticipate there will be 55,000 addressable breast cancer patients in the US by 2027, and the potential for $2.4 billion in annual sales across the US and major European markets by 2033.

Another important aspect of our BD conversation centers around where we will take pela next on the regulatory pathway.

After multiple discussions with key opinion leaders and statisticians, 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.

We believe this is reasonable because the PFS benefit we would aim to achieve is 4.3 months, but the [BRACELET] benefit was 5.7 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 all companies, including the approval of IBRANCE for Pfizer and ENHERTU for Daiichi.

Now 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 a fortunate position to have a compelling data in three indications: breast, pancreatic, and anal cancers.

This indication demonstrate the broad potential for pelareorep to help a large number of patients and provide a commercial opportunity that is appealing to potential biopharma partners.

In the GI space, GCAR and PanCAN remain our valued collaborators.

We're excited that GOBLET Cohort 5 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, PanCAN provided Oncolytics with a $5 million grant to fully form Cohort 5 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 in pela's potential give us confidence in the strategy to continue evaluation in this indication.

PanCAN's continued interest in pela is helping us to provide a more complete picture of pela's potential in this extremely difficult-to-treat type of cancer.

This is due to the fact that the treatment regimen in this [court] is evaluating treatment with a different chemotherapy that we have used in the past, modified FOLFIRINOX.

This is one of the two most commonly administered to metastatic pancreatic cancer patient, the other being gemcitabine and nab-paclitaxel.

The combination of pela, gemcitabine, nab-paclitaxel, and atezolizumab showed a 62% objective response rate, well above the usual 20, 25 response rate that would be expected in a similar patient population.

In turn, that data led to the relationship with PanCAN as well as a fast track designation from the FDA and the opportunity to collaborate with GCAR.

We continue to engage with GCAR to finalize a master protocol for initiating a registration-enabling study that could eventually lead to regulatory approval for the pela, gemcitabine, nab-paclitaxel, 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 to Kirk for a review of our financials.

Kirk?

Thanks, Christophe, and 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 on the Investors section of our website under filings and reports, or in the press release issued earlier this morning.

Now throughout 2024, we remained cautious with our cash resources.

As of December 31, 2024, the company reported $15.9 million in cash and cash equivalents.

Net cash used in operating activities for 2024 totaled $27 million compared to $28.4 million for 2023, reflecting noncash working capital changes, partially offset by higher net operating activities in 2024.

Now general and administrative expenses for the fourth quarter of 2024 were $3.9 million compared with $4.2 million for the fourth quarter of 2023.

The decrease was mainly attributed to lower personnel-related expenses incurred in 2024, along with lower cash annual short-term incentive awards.

The decrease was partly offset by higher share-based compensation expense.

Research and development expenses for the fourth quarter of 2024 were $4.6 million compared to $4.7 million for the fourth quarter of 2023.

The decrease was due to lower personnel-related expense 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 2024 was $8 million compared to a net loss of $3.9 million for the fourth quarter of 2023.

The basic and diluted loss per share was $0.10 in the fourth quarter of 2024 compared to a basic and diluted loss per share of $0.05 in the fourth quarter of 2023.

For the full-year 2024, net loss totaled $31.7 million compared to $27.8 million in 2023 or $0.41 per share on a basic and fully diluted basis.

As we look forward to 2025, we are confident in the vast potential that pela holds for improving patient outcomes.

We are making progress, as shown by the recent data on pancreatic and anal cancers announced at ASCO GI.

And we are dedicated to advancing pela as effectively and efficiently as possible.

Now before we wrap up today's call, I'd like to thank everyone who continues to support our efforts, 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&A.

Operator?

(Operator Instructions) Michael Freeman, Raymond James.

Hi, good morning, Kirk, Wayne, Tom, Christophe, Jon.

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 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 would 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 identified sites through feasibility and working with their process to get them on board.

And then once we once have that sites identified and ready to be put on board, we'll look to bring them online.

And then we'll start to -- 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 18-month enrollment period with a six-month data maturity to get to PFS readout.

So in the interim, we're looking at putting in place a futility analysis, and we're -- we have to finalize that assessment.

But our expectations right now is a futility analysis will take about 14 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 speak to that in any great detail.

But as we understand our sites and their enrollment rates, et cetera, 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 an oncolytic virus renaissance going on.

And are you seeing increased interest from pharma?

As a result, like I point specifically to CG Oncology, they were able to raise about $200 million at the end of last year on good data.

And that's a live virus.

Curious how you're seeing things -- I'm curious for 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.

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 Candel 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 a significant advantage being injected instead of -- I mean, IV injection and not an intratumor and that the intratumor has been sometimes a little complicated for big pharma companies that are 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 a very strong data -- but the strong signal we've seen in other indications, pancreatic and anal, resonate very well with potential companies.

Kirk, do you want to add anything to that?

Yeah.

And what we're noticing on kind of discussions and presentations with investors is, again, more interest in the OB space.

We're seeing more dedicated clinicians, science experts from those investors sitting down and talking to us, and walking through our data and our plan.

And there's been some comments 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 is a real opportunity.

So that and a combination of 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.

Yeah, a good rising tide situation, I hope.

And if I can shoehorn one last one in.

I wonder on the pancreatic front and your alignment with GCAR, I understand that you're working together to 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 allow and get together a master protocol.

But I wonder if there's any way that this trial can be accelerated to launch?

Jon, can you speak to it?

Yeah, I can speak to that.

But the -- we have been working, as Kirk mentioned, very actively with GCAR to finalize licensure-enabling study protocol.

The next step would be, as typical in these sort of situations, would be to go to the regulators 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 forward with them at the greatest possible pace.

Okay.

All right.

Thank you very much.

I look forward to seeing all your activity this year.

I'll pass it on.

(Operator Instructions) Patrick Trucchio, H.C. Wainwright.

Good morning, everyone.

Thank you for taking the questions.

Luis here for -- in for Patrick.

Congratulations on the latest presentations.

We are curious to know what your thoughts are around the positioning, the commercial positioning, of pela given that ADCs seem to have shown and continue to show positive results in 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, for this kind of therapy.

Is there any other population that you could target regarding the ADCs?

And do you think that there's a potential also for combination, not just as a sequential treatment approach, but a combination with ENHERTU and other ADCs?

Thank you.

Sure.

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, okay, 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 the 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 I'm sorry, what was the second part of your question, please?

We're wondering if there's any potential for combination with (technical difficulty) therapies?

Yeah, yeah, sorry.

So pelareorep, in general, has proven itself to be an agent that can potentiate the activity of other therapies, including chemotherapy and immunotherapies.

So 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 at the appropriate time in the future, combination therapy with ADCs and other agents would certainly be something worth considering.

Great.

Thank you.

And this is Christophe.

I can add a little color on the -- more on the number of patients for you.

As you may recall, we discussed our total addressable patient population of 55,000 patients just in the US.

And when you look at that, it's mostly for patients who would have been on ENHERTU and would have initially responded, and then would relapse, which is -- as you look at ENHERTU, your average PFS is 10 to 11 months.

So we know that this patient at some point in time will need another better treatment -- another treatment.

So when we build our forecast of that total to more than $2 billion, that considers 55,000 patients annually in the US.

And then we take a very conservative approach with 15% to 20% market share in this population.

So that's why we believe there's a significant market opportunity.

Okay.

Any 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 Look for closing remarks.

Well, thanks to everybody who took the time to join our earnings call this morning.

This is going to be an exciting year for pela and Oncolytics, with additional data readouts expected and the planning of registration-enabling studies that can move pela closer to regulatory approval.

Thanks again for your support, and 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.