Oncolytics Biotech Q1 2024 Earnings Call Transcript

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May 9, 2024

There are 5 speakers on the call.

Operator

Good afternoon, and welcome to Oncolytics Biotech's First Quarter 2024 Conference Call. All participants are now in listen only mode. 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 Patten, Director of Investor Relations and Communications. Please go ahead.

Speaker 1

Thank you, operator, and good afternoon, everyone. Earlier today, Enclave issued a press release providing recent operational highlights and financial results for the Q1 of 2024. A replay of today's call will be available on the Events section of the Oncolytics website approximately 2 hours after its completion. After remarks from company management, we will open the call for Q and A. As a reminder, various remarks made during 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, company's belief as a potential and mechanism of action of pelareoreb as a cancer therapeutic, our belief that we are positioned to begin registration track studies in breast and pancreatic cancer and our strategies and upcoming milestones in connection therewith our critical objectives for 2024 the anticipated timing and the release of additional data, company's belief that it has sufficient cash to achieve these milestones and other statements related to anticipated developments in the company's business.

Speaker 1

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 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 these statements 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. I'm joined by several members of the Oncolytics management team to review our Q1 2024 results and corporate updates, including Chief Executive Officer, Doctor.

Speaker 1

Matt Coffey Chief Financial Officer, Kirk Look and Chief Medical Officer, Doctor. Tom Heinemann. Doctor. Coffey will begin our discussion today. Matt, please take it away.

Speaker 2

Thank you, John. Good afternoon and welcome to Oncolytics' Q1 conference call. Oncolytics' mission is to improve the lives of people with cancer by bringing our proprietary immunotherapeutic product candidate pelareorep or Pella as we'll refer to it to patients as quickly as possible. We are taking the next steps to make that happen as we transition to become a late stage cancer company by progressing pellet in our 2 lead indications, breast cancer and pancreatic cancer. As we'll discuss throughout the call, we are building the necessary foundation to begin registrational track studies for both of these indications for which there is urgent need for new or alternative therapies.

Speaker 2

We have organized today's call to provide you with a comprehensive update on our progress and upcoming milestones. I'll spend a few moments sharing what excites us about Pella and touch on our recent developments, upcoming milestones and key corporate messages. After that, I will ask Tom to provide an update on the breast cancer program, the new goblet pancreatic cancer cohort, the expansion of the goblet anal cancer cohort and initial plans for the registrational Tract pancreatic cancer study. Then I'll ask Kurt to review the financials. And finally, we will end by taking your questions.

Speaker 2

I'll start with a brief note on what makes pellet such a compelling immunotherapy candidate. In a nutshell, it's all about results. Pellet is delivered intravenously and works systemically. It is able to selectively replicate tumors and introduce double stranded RNA into these cancer cells. This results in generating, recruiting and training immune cells to begin identifying cancer cells to enable cancer self killing in addition to remodeling the tumor microenvironment to activate immune cells.

Speaker 2

This has made pellet unique because the responses pellet generates have led to synergies with multiple cancer treatments, including chemotherapy, immune checkpoint inhibitors, CAR T cell therapy and others. These synergies come from 2 randomized breast cancer studies, multiple studies in pancreatic cancer and recently there's been an intriguing efficacy signal in the anal cancer cohort of our goblet study, which included a complete response even in the absence of standard cytotoxic chemotherapies. In these clinical trials, Pella was used in combination with chemotherapy drugs like now paclitaxel or immune checkpoint inhibitors like atezolizumab. Compelling data from these studies showed that the treatment with PELLA produced meaningful clinical responses with favorable comparisons to historical controls as in the case of goblet were in randomized controlled trials demonstrated in breast cancer. It's demonstrated a positive association between increases in tumor infiltrating lymphocytes or TILs and tumor responses and it was well tolerated by patients.

Speaker 2

Taken together, these data form the basis of our enthusiasm for PRPELA as a novel differentiated immunotherapeutic agent and supports our plans to provide with registration track studies. 2024 is off to a promising start. We're building on our compelling pellet clinical databases and continuing our transition to become a late stage oncology company. A few notable milestones to mark our year to date progress. We've been granted a Type C meeting with the FDA for a Q2 2024 meeting to discuss our planned registrational enabling study in breast cancer.

Speaker 2

Defining this registration path for PELA in breast cancer is a pivotal clinical goal for the year. We expanded enrollment for the cancer cohort at the GALBA study to strengthen the already promising signal of efficacy. This is important because it could open the door to a new registrational indication and accelerated approval for pathway. We received regulatory clearance to begin enrolling patients in a new pancreatic cancer cohort in GOVELT study. This cohort will evaluate pellet in combination with a widely used chemotherapy regimen called modified fulferonox with and without atezolizumab.

Speaker 2

The study is supported by a U. S. $5,000,000 grant from the Cancer Action Network, also known as PANCAN, which provides additional positive validation for PELLAF. We affirm plans to report overall survival data from the Phase 2 bracelet breast cancer study in H2 2024. While we have reported overall survival response data for pelapaclitaxel that is 3x paclitaxel monotherapy, overall survival data continues to mature.

Speaker 2

This has the potential to be a major catalyst as we have already had another metastatic breast cancer study called IND-two thirteen, the near to median overall survival for patients. We announced that 2 abstracts related to clinical and translational data were selected for presentation at the Annual Meeting of the American Society For Clinical Oncology or ASCO 2024, which we'll be able to discuss in more detail later this month. We continue to maintain the NAPTIST dialogue with our clinical collaborators and potential strategic partners. These discussions provide valuable perspectives that have shaped and enriched our registrational study plans. Looking ahead, we remain laser focused on our critical objectives for 2024.

Speaker 2

In H1 twenty twenty four, we intend to provide guidance on the registration path for pyla in breast cancer. Over the coming months, we expect to enroll the 1st patient in Cohort 5 of the goblet study, which is evaluating PELLA plus modified falferonox with and without atebolizumab in pancreatic cancer patients. Also in H2 2024, we expect to report overall survival data from the BRACELE-one breast cancer study. Now before I turn the call over to Tom to provide you with an update on our clinical programs, I'd like to thank everyone in the Oncletics organization and our collaborators for the dedication that you bring to our mission every day to improve the care of patients with cancer. Your work and unwavering commitment is critical to advancing the development of Pella.

Speaker 2

Tom?

Speaker 3

Thanks, Matt. During today's call, I will provide an update on oncolytics breast cancer program, the new pancreatic cancer cohort in the goblet study, the expansion of the goblet study anal cancer cohort and our plans for a registrational track pancreatic cancer study. Over the coming months, we will provide updates on our ongoing clinical trials as new results become available. Starting with our breast cancer program, I'd like to touch on 3 topics. 1st, our thoughts on the most appropriate registrational trial.

Speaker 3

Next, the upcoming Type C meeting with the FDA to discuss our breast cancer program. And finally, the BRACELETE-one study survival results. Let me start with our thoughts on what constitutes a registrational trial in breast cancer. As the BRACELET-one data has continued to mature, we have spent the past year speaking with our clinical advisors, collaborators and potential partners about registrational trial strategies for new breast cancer therapeutics. The strategy that has emerged from these The strategy that has emerged from these discussions is to advance Pella to regulatory approval in breast cancer utilizing a cost effective approach that optimizes study timelines and retain sufficient flexibility to adapt to the evolving breast cancer treatment space.

Speaker 3

Our conversations with potential pharmaceutical partners has emphasized the value of conducting an efficiently sized randomized controlled study that with positive data could lead directly to a registrational filing or to substantially de risk a subsequent Phase 3 study. It is notable, for example, that Pfizer's CDK4six inhibitor, Ibrance, received its initial approval in breast cancer based on the 165 patient PALOMA-one study. On the topic of our upcoming Type C meeting, as Matt indicated, defining the registrational path for Pela in breast cancer is a major goal for Oncolytics in 2024. Earlier this year, we submitted a Type C meeting request to the FDA and the meeting will take place in the Q2 of 2024. At this meeting, we will discuss our proposed next breast cancer clinical trial with the FDA, including the anticipated study design, study population and study endpoints.

Speaker 3

Through this interaction, we expect to align with the agency on the optimal clinical approach, which will allow us to move forward confidently as we continue to develop pelus as a treatment option for breast cancer patients. Next, the BRACET 1 survival data. We previously reported strong tumor response and progression free survival results from the BRACE-one study. Overall survival results from BRACE-one, which have not yet been reported due to ongoing patient follow-up are anticipated later this year. As Matt mentioned, the earlier IND-two thirteen study showed a significant survival benefit in HR positive HER2 negative metastatic breast cancer patients who received the combination of Pella and paclitaxel compared to paclitaxel alone.

Speaker 3

A strong overall survival in the pelapaclitaxel arm in BRACE will serve to validate these earlier findings and will support discussions with potential strategic partners and with regulators. Moving to the goblet study, I'll touch on 2 topics. First, the expansion of the anal cancer cohort and then the new cohort in goblet study evaluating Pella combined with modified filferonox. By way of background, the goblet study is a platform study designed to assess the potential of Pela's combination therapies to benefit patients with advanced or metastatic gastrointestinal cancers. It is being conducted at 12 centers in Germany and is being managed by our clinical collaborator, the AIO study group.

Speaker 3

To date, we have evaluated 3 cohorts, first line metastatic pancreatic ductal adenocarcinoma or PDAC, third line metastatic colorectal cancer and second line or later anal cancer. In each of these indications, the PELLA based combination therapy met the initial predefined success criteria. Starting with anal cancer, on February 14, we announced plans to initiate the expansion of enrollment into this cohort based on positive preliminary results, which were reported at an international medical meeting in November of last year. It is notable that this cohort evaluates the combination of Pella and atezolizumab without chemotherapy in patients with second line or later disease. Positive results from the expanded anal cancer cohort may open the door to an accelerated registrational path.

Speaker 3

A modest expansion of fewer than 28 patients is expected to be sufficient to confirm the benefit we've seen so far and to provide the basis for a registrational study, which we anticipate would be the next logical step. We are actively enrolling patients into this study as well as adding new sites. We intend to report additional anal cancer results in 2025. Moving to the modified filperidox pancreatic cancer study, on March 5, we announced plans to initiate a new pancreatic cancer cohort in the goblet study. New cohort supported by a $5,000,000 grant from PanCAN will evaluate Pella in combination with modified filferonox with or without atezolizumab patients with newly diagnosed PDAC.

Speaker 3

This study complements our ongoing development of Pella in combination with gemcitabine and nab paclitaxel, the other commonly used chemotherapy for metastatic pancreatic cancer. Evaluating Pella in combination with both of these widely used chemotherapeutic regimens will broaden the scope of our clinical development program with the goal of making Pella based therapies available to the widest possible range of pancreatic cancer patients. Earlier this morning, we announced that we had received regulatory approval to move forward with the Pella modified FOLFIRINOX combination study and we expect to enroll patients beginning in the Q2 of this year. In closing, I'd like to discuss our registrational plans for Pella in pancreatic cancer. Our registrational strategy will focus on Pella in combination with atezolizumab, gemcitabine and nab paclitaxel in patients receiving first line treatment for metastatic pancreatic cancer.

Speaker 3

We continue to develop a study protocol that utilizes an adaptive design building on the positive results from cohort 1 of the goblet study. We expect to provide an update on these plans this quarter. Before I close, I'd like to express our deep thanks to everyone who has participated in or supported our clinical program. We are very grateful for your valuable contributions. Now, I'd like to turn the call over to Kirk to review the financial results for the Q1 of 2024.

Speaker 2

Thanks, Tom, and good afternoon, everyone. During this portion of the call discussing our financial results, I will be providing data 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 afternoon. As you all will hear, we have taken a responsible approach to our financial strategy and spending. The company closed the Q1 with $29,600,000 in cash and cash equivalents compared to $34,900,000 in cash and cash equivalents as of December 31, 2023.

Speaker 2

We believe this will enable us to achieve the milestones discussed in today's call. The net loss for the Q1 of 2024 was $6,900,000 compared to $6,400,000 in the Q1 of 2023, equating to a net loss of $0.09 per share in the Q1 of 2024 compared to a net loss of $0.10 per share for the same period in 2023. Now general and administrative expenses for the Q1 of 2024 were $3,000,000 compared to $3,200,000 for the Q1 of 2023. The change was primarily due to lower public company related expenses associated with lower Investor Relations activities and lower directors and officers liability insurance premiums. Research and development expenses for the Q1 of 2024 were $5,700,000 compared to $3,500,000 for the Q1 of 2023.

Speaker 2

The change was mainly driven by higher manufacturing expenses associated with completing a cGMP production run and the related batch testing. We've also begun preparation for an upcoming product fill. Now this is an exciting time for Oncolytics as we position the company to make the jump to a late stage oncology company. We look forward to providing updates on our progress, especially in regard to the registration enabling studies for breast and pancreatic cancer. I'll now give the call back to Matt for closing comments.

Speaker 2

Matt? Thanks, Kirk. As we conclude today's call, I hope you take away these key messages. PELLA is on track to advance the registrational trials in breast cancer and pancreatic cancer. We believe our robust, positive clinical and translational data supports Pella's MOA as an immunotherapeutic agent.

Speaker 2

We expect to report overall survival data from the BRACELET-one breast cancer study in H2 twenty twenty four. The PELA data set has attracted and enriched the interest of clinical oncology community and potential strategic partners. And finally, expanded enrollment in the anal cancer cohort at a goblet study could open the door to a new registrational indication. As Kirk mentioned, we are enthusiastic about the groundwork we have laid so far this year as we move closer to starting enabled studies to bring pellet closer to regulatory approval. I don't think I've ever been more excited about our data sets and the productive discussions that we've been having with key opinion leaders, our clinical collaborators and regulators.

Speaker 2

Operator, I would now like to open the call for questions.

Operator

Your first question comes from the line of John Newman from Canaccord. Please go ahead.

Speaker 1

Hi guys. Thanks a lot for taking my question. Just wondering if you could provide a little bit more color on the potential design of a pivotal study in metastatic breast cancer with Pella. Obviously,

Speaker 4

you're going

Speaker 1

to be meeting with the soon, but just curious, just generally speaking, sort of what that design could look like? Thanks.

Speaker 2

Thanks, John. I'm going to push Tom under the bus on this one. And it's interesting because I'm not sure if you saw the Destiny 6 results that came out yesterday because that certainly has bearing on what fortunately we were able to flag with the Type C meeting with the agency. And then very loosely, we could talk about comparable studies that I think would be basically modeled on or we've modeled on. And if there's any other questions at that, Tom, we'd be happy to help you out.

Speaker 3

Yes. Hi, John. So as we mentioned, we will be meeting with the FDA to discuss some of the key elements of our next breast cancer study. And among those key elements will be the population and that's what Matt was referring to is that we will we want to make sure that the population we evaluate in our next study is the most relevant population from the perspective of the current and future standard of care for these patients, right. And so the Destiny six results, which are expected shortly, will help shape the future standard of care in metastatic breast cancer patients who fail hormonal therapy.

Speaker 3

And so we want we have anticipated that and we'll have a specific discussion with the agency about the most appropriate population. We also plan to discuss some of the other key elements of the study design, including the primary endpoints and the statistical plan in general. And as we mentioned in our talk earlier, our goal is to design a study that is efficient, flexible as quick as possible and that offers the potential for an registration of pelareorep in this population.

Speaker 1

Great. Thank you.

Operator

Your next question is from the line of Rahul Sarugaser from Raymond James. Please go ahead.

Speaker 4

Hey, Matt, Kirk, Tom. This is Mike on for Rahul today. Congratulations on the action packed quarter. I have a question on the interaction between the 2 pancreatic cancer trials, the congratulations on announcing your green light on the ampliferinox trial. I'm curious about the I guess your go forward plan with these two trials in mind, the Cohort 1 trial seems to be is more advanced than the latter.

Speaker 4

I'm curious about your staging that you have in mind in respect to registration for those two trials.

Speaker 2

Mike, great question. And I'm glad to ask it because I think there's some confusion around why we would like pursue both first line studies. What we're finding from goblets is the earlier the patient, the more robust is the T cell response. So when we look at pancreatic, they had by strong by part of the strongest T cell response. Anal in the second line, the next and by the time we get the 3rd line colorectal, there's we met the success criteria, but there's more of a muted T cell response.

Speaker 2

So we want to stay in the first line setting. And there's a really nice paper by Jim Allison that just came out talking about how immunotherapy has become more and more ineffective with each round of treatment. So we did want to say in the first line setting, patients with pancreatic cancer even in the first line setting can be quite variable. Older patients, patients with adjuvant therapy, tend to get napac with Paxiltebene because it's considered to be more, I don't want to say gentle, but gentle is the right word. So you're going to see a little bit less than half the patients getting that.

Speaker 2

And we combine that based on results that we've had with cytabine and paclitaxel in the past. And I think did very, very well with that study. Interestingly, those patients were given gemnapacitaxel, because I think almost a third of them had received, vulprenox or modified vulprenox in the adjuvant phase. But we're not entirely sure it was really the adjuvant phase in the sense that it seemed that they had unclear margin. So they were almost like second line patients.

Speaker 2

Also those patients had a lot of liver met. So they were entirely appropriate patient population to get, Gemnab TreoT centric because they were more heavily appreciated and tend to have more burdensome disease. With the second study, it is randomized to modified pulpyrinox plus or minus tislelizumab. Our expectation here is that these patients will have much higher organ reserve, will have less pretreatment and hopefully, less liver metastases. So we can go in there and treat much more aggressively.

Speaker 2

And it will be much easier to characterize the role that we're seeing for TECENTRIQ. Looking at the results we've seen before, TECENTRIQ does enhance the inflammatory response. We do see greater numbers of NK and T cells in the presence of T centric and we get a lot less exhaustion markers in the presence of TECENTRIQ. So we do expect the modified fulferon and Oxpella arm to be successful, but we really do expect to see tremendous activity with the addition of TECENTRIQ because they just work so well hand in hand. And by addressing both groups, hopefully we become the standard of care for all first line patients in pancreatic irrespective of their pretreatment histories or organ reserve.

Speaker 2

Tom, did you want to add anything? Got you.

Speaker 3

Yes. No, no, I think that covers it. I think the bottom line is that by exploring Pella in combination with both of the backbone chemotherapies that are commonly used in this population, it provides an opportunity to treat ultimately the broadest range of patients and to give physicians the most flexibility possible and best option for all pancreatic cancer patients.

Speaker 4

Okay. Very helpful. And quickly, on the data that you seek to present at ASCO coming up, this Phase III trial with them for Pironox, I'm curious the from where this data drives and what maturity of data should we expect here and I guess the data cutoff date, we might be you might be presented to data?

Speaker 3

Yes. So just to be clear, the poster presentation that we'll have at ASCO related to the modified filferonox study is a trial in progress poster in which we outlined the details of the study that is currently well, that will at that time be currently enrolling, right. So there will be no data from that study presented at ASCO at this meeting.

Speaker 4

Got it. Thanks for clarifying. I'll pass it on.

Speaker 2

Operator, is there another question? Operator? Well, if there's no further questions, I just want to thank everyone for participating in today's call and for following Othlytics development. We're optimistic about the potential for Propella to make a big difference in the lives of cancer patients. I look forward to updating you on our progress throughout the year, and I wish everyone a great evening.

Speaker 2

Thanks so much.

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