Q1 2024 Oncolytics Biotech Inc Earnings Call

Operator: Good afternoon, and welcome to Oncolytics Biotech's first quarter 2024 conference call. All participants are now in listen-only mode. There will be a question and answer session at the end of this call. 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 Communication. Please go ahead.

Good afternoon, and welcome to uncle He takes biotechs first quarter 'twenty 'twenty four conference call. All participants are now in listen only mode. There will be a question and answer session at the end of this call.

Jon Patton: Please be advised that this call is being recorded at the company's request.

Jon Patton: I would now like to turn the call over to John Patten Director of Investor Relations and communications.

Jon Patton: Please go ahead.

Jon Patton: Thank you, Operator, and good afternoon, everyone. Earlier today, Oncolytics issued a press release providing recent operational highlights and financial results for the first quarter of 2024. A replay of today's call will be available on the events section of the Oncolytics website approximately two hours after its completion. After remarks from company management, we will open the call for Q&A. 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 Pellegrini Rep.

Jon Patton: Thank you operator, and good afternoon, everyone earlier today <unk> issued a press release, providing recent operational highlights and financial results for the first quarter of 2020 for a replay of today's call will be there while on the EBIT section of its web site approximately two hours after its completion.

Jon Patton: After remarks, no company management, we will open the call for Q&A as a reminder, various remarks made during this call contains certain forward looking statements relate to the company's business prospects and the development and commercialization to celebrate right. If any statements regarding the company's mission company's belief is it essentially the mechanism of action TV Europe as it catches therapeutics, our belief that we are.

Jon Patton: Including statements regarding the company's mission, the company's belief as an essential and mechanism of action of Pellegrini Rep. as a cancer therapeutic, our belief that we are positioned to begin registrational 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 release of additional data, the company's belief that it has sufficient cash to achieve its milestones, and other statements related to anticipated developments in the company's business.

Jon Patton: To begin Registrational studies in breast and pancreatic cancer, and our strategy and upcoming milestones in connection there with our critical objectives for 2020 for anticipated timing as it release of additional data companies believe that it has sufficient cash to achieve these milestones and other statements related to the Companys business.

Jon Patton: These statements are based on management's current expectations and beliefs and are subject to a number of factors that 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 mutually 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.

Jon Patton: 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 materially different from the results performance expectations implied by these forward looking statements.

Jon Patton: Any forward looking statements, which expresses an expectation or belief as to future results such expectations beliefs are especially in good faith and are believed to have reasonable basis, I think it'd be no assurance that these statements of expectations or belief will be achieved. These factors include results of current opinion clinical trials risks associated intellectual property protection financial protections actually.

Jon Patton: So by regulatory agencies and those other factors detailed in the company's filings with SEDAR and the SEC does not undertake any obligation to update these forward looking statements, except as required by applicable laws.

Jon Patton: These factors include the 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 CDAR and the SEC. Oncolytics does not undertake any obligation to update these forward-looking statements. I'm joined by several members of the Oncolytics Management Team to review our first quarter 2024 results and corporate updates, including Chief Executive Officer, Dr. Matt Coffey, Chief Financial Officer, Kirk Look, and Chief Medical Officer, Dr. Tom Heineman. Dr. Coffey will begin our discussion today. Matt, please take it away.

Speaker Change: I'm joined by several members of the Opex management team to review, our first quarter 2024 results and corporate updates, including Chief Executive Officer, Dr. Matt Coffey, Chief Financial Officer, Kirk look Chief Medical Officer, Dr. Tom side of it.

Matthew C. Coffey: Coffee will begin our discussion today, Matt please take it away.

Jon Patton: Okay.

Speaker Change: Thank you John.

Matthew C. Coffey: and Gunn. Good afternoon, and welcome to Oncolytics' first quarter conference call. Oncolytics' mission is to improve the lives of people with cancer by bringing our proprietary immunotherapeutic product candidate, Pella Rearept, 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 Pella in our two lead indications, breast cancer, and pancreatic cancer.

Speaker Change: Good afternoon, and welcome to <unk> first quarter conference call.

Matthew C. Coffey: <unk> mission is to improve the lives of people with cancer by bringing our proprietary immuno therapeutic product candidates Hello Railroad, where pillar is what we referred to it to patients as quickly as possible.

Matthew C. Coffey: We are taking the next steps to make that happen as we transitioned to become a late stage cancer company by progressing pellet in our two lead indications breast.

Matthew C. Coffey: Breast cancer and pancreatic cancer.

Matthew C. Coffey: 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. We have organized today's call to provide you with a comprehensive update on progress and upcoming milestones.

Matthew C. Coffey: As we'll discuss throughout the call. We are building the necessary foundation to begin Registrational trial studies for both of these applications for which there is urgent need for new or alternative therapies.

Matthew C. Coffey: We have organized today's call to provide you with a comprehensive update on our progress and upcoming milestones.

Matthew C. Coffey: I'll spend a few moments sharing what excites us about Pella and touching on our recent developments, upcoming milestones, and key corporate messages. After that, I will have Tom 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 Kirk to review the financials.

Matthew C. Coffey: I'll spend a few moments sharing what excites us about pillar and touch on our recent developments upcoming milestones and key corporate messages after.

Matthew C. Coffey: After that I will ask Tom to provide an update on the breast cancer program, the new goblet pancreatic cancer cohorts the expansion of the goblet anal cancer cohort at initial plans for the Registrational trials pancreatic cancer study.

Matthew C. Coffey: Then I will ask her to review the financials and finally, we will end by taking your questions.

Matthew C. Coffey: And finally, we will end by taking your questions. Let's start with a brief note on what makes Pella such a compelling immunotherapy candidate. In a nutshell, it's all about results. Pella is delivered intravenously and works systemically. It is able to selectively replicate in 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 cell killing in addition to remodeling the tumor microenvironment to activate immune cells.

Matthew C. Coffey: This has made Pella unique because the responses Pella generates have led to synergies with multiple cancer treatments, including chemotherapy, immune checkpoint inhibitors, CAR-T cell therapy, and others. These synergies come from two 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 In these clinical trials, Pella was used in combination with chemotherapy drugs like Nalpaclitaxel or immune checkpoint inhibitors like atezolizumab.

Matthew C. Coffey: I'll start with a brief note on what makes pellets, such a compelling immunotherapy candidate and.

Matthew C. Coffey: In a nutshell, it's all about results.

Matthew C. Coffey: Hello is delivered intravenously and work systemically.

Matthew C. Coffey: It is able to selectively replicate the tumors and introduce double stranded RNA into these cancer cells.

Matthew C. Coffey: This results in generating recruiting and training immune cells to begin identifying cancer cells to enable cancer cell, killing in addition to remodeling in the tumor microenvironment to activate immune cells.

Matthew C. Coffey: This is a totally unique because of the responses pellet generates have led to synergies with multiple cancer treatments, including chemotherapy.

Matthew C. Coffey: I mean checkpoint inhibitors car T cell therapy and others.

Matthew C. Coffey: These synergies come from two randomized breast cancer studies.

Matthew C. Coffey: Multiple studies in pancreatic cancer and recently Theres been an intriguing efficacy signal in the anal cancer cohort of our doublet study, which included a complete response, even in the absence of standard cytotoxic Chemotherapies.

Matthew C. Coffey: And these clinical trials pellets used in combination with chemotherapy drugs like Nab paclitaxel for immune checkpoint inhibitors like <unk> can.

Matthew C. Coffey: Compelling data from these studies show that treatment with Pella produced meaningful clinical responses with favorable comparisons to historical controls, as in the case of Goblet, or in randomized control trials, as we've demonstrated in breast cancer. It demonstrated a positive association between increases in tumor-infiltrating lymphocytes, or TILs, in tumor responses, and it was well-tolerated by patients. Taken together, these data form the basis of our enthusiasm for Pella as a novel, differentiated immunotherapeutic agent and support our plans to move ahead with registration-tracked studies. 2024 is off to a promising start.

Matthew C. Coffey: Impelling data from these studies showed that treatment with pella produced meaningful clinical responses with favorable comparisons to historical controls as in the case of goblet randomized controlled trials as we've demonstrated in breast cancer.

Matthew C. Coffey: It's demonstrated a positive association between increases in tumor infiltrating lymphocytes, or tills and tumor responses and it was well tolerated by patients.

Matthew C. Coffey: Taken together these data form the basis of our enthusiasm propeller as a novel differentiated immuno therapeutic agents and supports our plans to move ahead with the registration tracked studies.

Matthew C. Coffey: 2024 is off to a promising start we're building a compelling pellet clinical databases and continuing our transition to become a late stage oncology company.

Matthew C. Coffey: We're building our compelling teleclinical databases and continuing our transition to become a late-stage oncology company. A few notable milestones have marked 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. Defining this registration path for pellet therapy and breast cancer is a pivotal clinical goal for the year. We expanded enrollment for the anal cancer cohort in the Gallup study to strengthen the already promising signal of efficacy.

Matthew C. Coffey: Notable milestones Mark our year to date progress.

Matthew C. Coffey: We have been granted a type C meeting with the FDA for our Q2 2020 for meeting to discuss our planned registrational, enabling study in breast cancer.

Matthew C. Coffey: Defining this registration path propeller in breast cancer as a pivotal clinical goal for the year.

Matthew C. Coffey: We expanded enrollment for the anal cancer cohort combo study to strengthen the already promising signals of efficacy.

Matthew C. Coffey: This is important because it could open the door to a new registrational indication and accelerate approval for pathways. We received regulatory clearance to begin enrolling patients in a new pancreatic cancer cohort in the Goblet Study. This cohort will evaluate Pella in combination with a widely used chemotherapy regimen called modified fulfironox with and without tezolizumab. The study is supported by a U.S. $5 million grant from the Pancreatic Cancer Action Network, also known as PANCAN, which provides additional positive validation for PELA.

Matthew C. Coffey: This is important because it could open the door to a new registrational indication and accelerated approval for pathway.

Matthew C. Coffey: We received regulatory clearance to begin enrolling patients in a new pancreatic cancer cohort and goblet study.

Matthew C. Coffey: This cohort will evaluate <unk> in combination with a widely used chemotherapy regiment called modified <unk> with and without <unk>.

Matthew C. Coffey: This study is supported by a U S $5 million grant from the pancreatic cancer action network also known as <unk>, which provides additional positive validation propeller.

Matthew C. Coffey: We affirm plans to report overall survival data from the Phase 2 breast cancer study in H2 2024. While we have reported overall survival response data for pellipaclitaxel, that is three times paclitaxel monotherapy, overall survival data continues to mature. This has the potential to be a major catalyst, as we have already had another metastatic breast cancer study called IND213, which has a near-median overall survival rate. We announce that two abstracts related to clinical and translational data have been 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.

Matthew C. Coffey: We have firm plans to report overall survival data from the phase III bracelet breast cancer study in <unk> 2024.

Matthew C. Coffey: While we have reported overall survival response data for pellet Paclitaxel that is three times Paclitaxel monotherapy overall survival data continues to mature.

Matthew C. Coffey: Has the potential to be a major catalyst as we have already had another metastatic breast cancer study called <unk> 213.

Matthew C. Coffey: Both median overall survival for patients.

Matthew C. Coffey: We announced that two abstracts related to clinical and translational data were selected for presentation at the annual meeting of the American Society for clinical oncology or <unk> 2024.

Matthew C. Coffey: Which will be able to discuss in more detail later this month.

Matthew C. Coffey: We continue to maintain an active dialogue with our clinical collaborators and potential strategic partners. These discussions provide valuable perspectives that have shaped and enriched our registrational study plan. Looking ahead, we remain laser focused on our critical objectives for 2024.

Matthew C. Coffey: We continue to maintain an active dialogue with our clinical collaborators and potential strategic partners.

Matthew C. Coffey: These discussions provide valuable perspectives that have shaped and enriched our registrational study plans.

Matthew C. Coffey: Looking ahead, we remain laser focused on our critical objectives for 2024.

Matthew C. Coffey: In H1-2024, we intend to provide guidance on the registration path for pellet and breast cancer. In the coming months, we expect to enroll the first patient in Cohort 5 of the Goblet Study, which is evaluating Pella plus Modified Folfirinox with and without atezolizumab in pancreatic cancer patients. Also, in H2 2024, we expect to report overall survival data from the Bracelet 1 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 Oncolytics 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. Tom?

Matthew C. Coffey: In each one 2024, we intend to provide guidance on the registration path for <unk> in breast cancer.

Matthew C. Coffey: Over the coming months, we expect to enroll the first patient in cohort five of the Goblet study, which is evaluating <unk> plus modified fall fir logs with and without <unk> in pancreatic cancer patients.

Tom: Also in HQ2024, we expect to report overall survival data from the bracelet, one breast cancer study.

Matthew C. Coffey: 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 and your analytics organization and our collaborators for the dedication that you bring to our mission every day to improve the care of patients with cancer.

Tom: Your work and unwavering commitment has been critical to advancing the development of pillar Tom.

Thomas C. Heineman: 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 three topics.

Tom: Thanks, Matt.

Tom: Today's call.

Thomas C. Heineman: I will provide an update on alkylate expressed cancer program, the new pancreatic cancer cohort in the goblet study the.

Thomas C. Heineman: The expansion of the Goblet study anal cancer cohort and our plans for a registrational track pancreatic cancer study.

Thomas C. Heineman: Over the coming months, we will provide updates on our ongoing clinical trials as new results become available.

Thomas C. Heineman: Starting with our breast cancer program I'd like to touch on three topics.

Thomas C. Heineman: First, our thoughts on the most appropriate registrational trial. Next, the upcoming Type C meeting with the FDA to discuss our breast cancer program. And finally, the Bracelet One study survival results. Let me start with our thoughts on what constitutes a registrational trial and dress code.

Thomas C. Heineman: First our thoughts on the most appropriate registrational trial.

Thomas C. Heineman: Next the upcoming type C meeting with the FDA to discuss our breast cancer program and finally, the bracelet one study survival results.

Thomas C. Heineman: Let me start with our thoughts on what constitutes a registrational trial in breast cancer.

Thomas C. Heineman: As the Bracewell-1 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 discussions is to advance pellet to regulatory approval in breast cancer, utilizing a cost-effective approach that optimizes study timelines and retains sufficient flexibility to adapt to the evolving breast cancer treatment space. Our conversations with potential pharmaceutical partners emphasized the value of conducting an efficiently sized, randomized control study. DAPT, with positive data, could lead directly to a registrational filing or to substantially de-risk a subsequent phase 3 study.

Thomas C. Heineman: It's a bracelet one data.

Thomas C. Heineman: Continued to mature we have spent the past year speaking with our clinical advisors collaborators and potential partners about registrational trials strategies for new breast cancer therapeutics.

Thomas C. Heineman: The strategy that has emerged from these discussions is to advance power to regulatory approval in breast cancer utilizing our cost effective approach that optimizes study timelines and retaining sufficient flexibility to adapt to the evolving breast cancer treatment space or conversations with potential pharmaceutical partners.

Thomas C. Heineman: As emphasized the value of conducting an efficiently sized randomized control study, perhaps with positive data.

Thomas C. Heineman: Could lead directly to a registrational filing or to substantially de risk a subsequent phase III study.

Thomas C. Heineman: It is notable, for example, that Pfizer's CDK46 inhibitor, Ibram, received its initial approval for breast cancer based on the 165 patient Paloma 1 study. On the topic of our upcoming Type C meeting, as Matt indicated, defining the registrational path for pellet and 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 second quarter of 2024.

Thomas C. Heineman: It is notable for example that Pfizer CDK <unk> inhibitor <unk> received its initial approval in breast cancer based on the 165 patient Paloma one study.

Thomas C. Heineman: On the topic of our upcoming type C meeting as Matt indicated defining the registrational path for <unk> in breast cancer is a major goal shrunk robotics in 2024.

Thomas C. Heineman: Earlier this year, we submitted a type C meeting request to the FDA.

Thomas C. Heineman: And the meeting will take place in the second quarter of 2024 at this meeting we will discuss our proposed next breast cancer clinical trial with the FDA.

Thomas C. Heineman: At this meeting, we'll discuss a proposed next breast cancer clinical trial with the FDA, including the anticipated study design, study population, and study end. 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 PEL as a treatment option for breast cancer patients. Next, the Bracelet-1 survival data.

Thomas C. Heineman: Including the anticipated study design study population and study endpoints.

Thomas C. Heineman: Through this interact should 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 <unk> as a treatment option for breast cancer patients.

Thomas C. Heineman: We previously reported strong tumor response and progression-free survival results from the Bracelet 1 study. Overall survival results from BRSA1, which have not yet been reported due to ongoing patient follow-up, are anticipated later this year. As Matt mentioned, the earlier IND213 study showed a significant survival benefit in HR-positive, HER2-negative metastatic breast cancer patients who received a combination of Pella and Paclitaxel compared to Paclitaxel alone. A strong overall survival in the Pella-paclitaxel arm in bracelet 1 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 two topics.

Thomas C. Heineman: Next the bracelet one survival data.

Thomas C. Heineman: We previously reported strong tumor response and progression free survival results from the bracelet one study ofer.

Thomas C. Heineman: Overall survival results from bracelet, one which have not yet been reported due to ongoing patient follow up are anticipated later this year.

Thomas C. Heineman: As Matt mentioned.

Thomas C. Heineman: Earlier <unk> 203 study showed a significant survival benefit in HR positive <unk> negative metastatic breast cancer patients, who received the combination of color and paclitaxel compared to Paclitaxel alone.

Thomas C. Heineman: Our strong.

Thomas C. Heineman: Overall survival in the power Paclitaxel arm Embracement, one will serve to validate these earlier findings, we will support discussions with potential strategic partners and with regulators.

Thomas C. Heineman: First, the expansion of the anal cancer cohort and then the new cohort in the Goblet Study, evaluating Pella combined with modified fulfirin. By way of background, the GOBLET study is a platform study designed to assess the potential of pellet-based combination therapies to benefit patients with advanced or metastatic gastrointestinal cancer. It is being conducted at 12 centers in Germany and is being managed by our clinical collaborator, the AIO Study Group. To date, we have evaluated three cobalts.

Thomas C. Heineman: Moving to the Goblet study.

Thomas C. Heineman: I'll touch on two topics.

Thomas C. Heineman: First the expansion of the anal cancer cohort and then the new cohort and Godless study evaluating pillar combined with modified Sofia.

Thomas C. Heineman: By way of background. The goblet study as a platform study designed to assess the potential of pellet based combination therapies to benefit patients with advanced or metastatic gastrointestinal cancers.

Thomas C. Heineman: It is being conducted a 12 centers in Germany and is being managed by our clinical collaborator the AI.

Thomas C. Heineman: <unk> study.

Thomas C. Heineman: To date, we have evaluated three cohorts first line metastatic pancreatic ductal adenocarcinoma or PD AC.

Thomas C. Heineman: 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, Pella-based combination therapy met the initial predefined success criteria. Starting with anal cancer, on February 14th, 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 a combination of Pella and tezolizumab 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.

Thomas C. Heineman: Third line metastatic colorectal cancer and second line or later anal cancer and each of these indications the pellet based combination therapy met the initial pre defined success criteria start.

Thomas C. Heineman: Starting with anal cancer on February 14th 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.

Thomas C. Heineman: It is notable that this cohort to evaluate the combination of <unk> and the T cell leukemia without chemotherapy in patients with second line or later disease.

Thomas C. Heineman: Positive results from the expanded <unk> cancer cohort may open the door to an accelerated registrational path.

Thomas C. Heineman: A modest expansion of fewer than 20 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.

Thomas C. Heineman: Modest expansion of fewer than 20 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.

Thomas C. Heineman: Which we anticipate will be the next logical step.

Thomas C. Heineman: We are actively enrolling patients into the study as well as adding new sites.

Thomas C. Heineman: We intend to report additional interim cancer results in 2025 move.

Thomas C. Heineman: Moving to the Modified Full Paradox Pancreatic Cancer Study, on March 5th, we announced plans to initiate a new pancreatic cancer cohort in the GOBLET study. The new cohort, supported by a $5 million grant from PAMCAP, will evaluate Pella in combination with modified fulfirinox, with or without atezolizumab, in patients with newly diagnosed PDAC.

Thomas C. Heineman: Moving to the modified full paradox pancreatic cancer study on March 5th we announced plans to initiate a new pancreatic cancer cohort in the <unk> study the.

Thomas C. Heineman: The new cohort.

Thomas C. Heineman: Courted by a $5 million ramps from Pan Kim will evaluate pillar in combination with modified <unk> with or without <unk> in patients with newly diagnosed <unk>.

Thomas C. Heineman: TD AC.

Thomas C. Heineman: This study complements our ongoing development of Pella in combination with gemcitabine and napaclitaxel, 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 Fulfurinox Combination Study, and we expect to enroll patients beginning in the second quarter of this year. In closing, I'd like to discuss our registrational plans for pellet and pancreatic cancer. Our registration strategy will focus on Pella in combination with atezolizumab, gemcitabine, and nabpaclitaxel in patients receiving first-line treatment for metastatic pancreatic cancer.

Thomas C. Heineman: This study complements our ongoing development of <unk> in combination with Gemcitabine and Nab paclitaxel. The other commonly used chemotherapy for metastatic pancreatic cancer.

Thomas C. Heineman: In evaluating <unk> in combination with both of these widely used chemotherapeutic regimens will broaden the scope of our clinical development program with the goal of making pillar based therapies available to the widest possible range of pancreatic cancer patients.

Thomas C. Heineman: Earlier. This morning, we announced that we had received regulatory approval to move forward with the pillar modified fulfill <unk> combination study and we expect to enroll patients beginning in the second quarter of this year.

Thomas C. Heineman: In closing I'd like to discuss our Registrational plans for pellets in pancreatic cancer.

Thomas C. Heineman: Our registrational strategy will focus on pillar in combination with the teaser map gemcitabine and Nab paclitaxel in patients receiving first line treatment for metastatic pancreatic cancer. We continue to develop a steady protocols that utilizes an adaptive design building on the positive results from cohort one of the <unk>.

Thomas C. Heineman: 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 contribution. Now, I'd like to turn the call over to Kirk to review the financial results for the first quarter of 2024.

Kirk: <unk> study.

Kirk: We expect to provide an update on these plans this quarter.

Kirk: Before I close I would 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.

Kirk: Now I'd like to turn the call over to Kurt to review the financial results for the first quarter of 2024.

Kirk: Thanks, Tom and good afternoon, everyone.

Kirk J. Look: 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 first quarter with $29.6 million in cash and cash equivalents compared to $34.9 million in cash and cash equivalents as of December 31st, 2023.

Kirk: During this portion of the call discusses our financial results I will be providing data in Canadian dollars unless otherwise noted.

Kirk J. Look: A full summary of our financial results can be found on the investors section of our website under filings and reports or in the press release issued earlier this afternoon.

Kirk J. Look: As you all well here, we've taken a responsible approach to our financial strategy and spending.

Kirk J. Look: Company closed the first quarter with $29 $6 million in cash and cash equivalents compared to $34 9 million in cash and cash equivalents as of December 31 2023.

Kirk J. Look: We believe this will enable us to achieve the milestones discussed in today's call. The net loss for the first quarter of 2024 was $6.9 million, compared to $6.4 million in the first quarter of 2023, equating to a net loss of $0.09 per share in the first quarter 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 first quarter of 24 were $3 million, compared to $3.2 million for the first quarter of 2023.

Kirk J. Look: We believe this will enable us to achieve the milestones discussed in today's call.

Kirk J. Look: The change is 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 first quarter of 2024 were $5.7 million, compared to $3.5 million for the first quarter of 2023. The change was mainly driven by higher manufacturing expenses associated with completing a CGMP production run and the related batch testing.

Kirk J. Look: The net loss for the first quarter of 2024 was $6 9 million compared to $6 4 million in the first quarter of 2023 equating to a net loss of nine <unk> per share in the first quarter of 2024 compared to a net loss of <unk> 10 per share for the same period in 2023.

Kirk J. Look: General and administrative expenses for the first quarter of 24 were $3 million.

Kirk J. Look: Impaired to $3 2 million for the first quarter of 2023.

Kirk J. Look: The change was primarily due to lower public company related expenses associated with lower Investor relations activities at lower directors and officers liability insurance premiums.

Kirk J. Look: Our research and development expenses for the first quarter of 2024 were $5 7 million compared.

Kirk J. Look: Compared to $3 5 million for the first quarter of 2023.

Kirk J. Look: Change was mainly driven by higher manufacturing expenses associated with completing the cgmp production run and the related batch testing. We have also begun preparation for upcoming product Phil.

Matthew C. Coffey: We've also begun preparation for an upcoming product film. 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.

Matt: So this is an exciting time for our clinics as we positioned the company to make the jump to a late stage oncology company.

Matt: We look forward to providing updates on our progress, especially in regard to the registration, enabling studies for breast and pancreatic cancer.

Matthew C. Coffey: I will now give the call back to Matt for closing comments Matt.

Matthew C. Coffey: Thanks, Kirk. As we conclude today's call, I hope you take away these key messages. Kelly is on track to advance registrational trials in breast cancer and pancreatic cancer. We believe our robust, positive clinical and translational data support PELUS-MOA as an immunotherapeutic agent. We expect to report overall survival data from the Bracelet 1 breast cancer study in H2 2024. The Pella dataset has attracted and enriched the interest of the clinical oncology community and potential strategic partners.

Matt: Thanks Kirk.

Matt: As we conclude today's call I hope you take away the key messages.

Matthew C. Coffey: Paula is on track to advance our Registrational trials in breast cancer and pancreatic cancer.

Matthew C. Coffey: We believe our robust positive clinical and translational data supports <unk> MLA as an immuno therapeutic agent.

Matthew C. Coffey: We expect to report overall survival data from the bracelet, one breast cancer study in <unk> 2024.

Matthew C. Coffey: Capella datasets has attracted and enrich the interests of the clinical oncology community and potential strategic partners and.

Matthew C. Coffey: And finally, expanded enrollment in the anal cancer cohort in a goblet study could open the door to a new registrational indication. As Kirk mentioned, we're enthusiastic about the groundwork we have laid so far this year as we move closer to starting the registration and enable studies to bring Pella closer to regulatory approval. I don't think I've ever been more excited about our datasets and the productive discussions that we've been having with key opinion leaders, our clinical collaborators, and regulators. Operator, I would now like to open the call to questions.

Matthew C. Coffey: And finally expanded enrollment in the annual cancer cohort at a Gaba study could open the door to a new registrational indication.

Matthew C. Coffey: As Kirk mentioned, we are enthusiastic about the groundwork we have laid so far this year as they move closer to starting the registration, enabling studies to bring pellet closer to regulatory approval.

Matthew C. Coffey: I don't think ive ever been more excited about our datasets and the productive discussions that wouldn't have any key opinion leaders, our clinical collaborators and regulators operator, I would now like to open the call for questions.

Speaker Change: Thank you.

Operator: Ladies and gentlemen, we will now begin the question-and-answer session. Should you have a question, please press star followed by the number 1 on your touchtone phone. You will hear a prompt that your hand has been raised. Should you wish to decline from the polling process, please press star followed by the number 2. If you are using a speakerphone, please lift the handset before pressing any button. Your first question comes from the line of Jon Newman from Canaccord. Please go ahead.

Speaker Change: Ladies and gentlemen, we will now begin the question and answer session should you have a question. Please press star followed by the number one on your Touchtone phone.

Operator: <unk> had has been raised.

Operator: Should you wish to decline from the polling process. Please press star followed by the number two if you are using a speaker phone. Please lift the handset before pressing any keys.

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

Jon Patton: Hi guys. Thanks a lot for taking my question. I just wondered if you could provide a little bit more color on the potential design of a pivotal study in metastatic breast cancer with Pella. Obviously, you're going to be meeting with the agency soon, but just curious, just generally speaking, sort of what that design could look like.

Jon Patton: Hi, guys. Thanks, a lot for taking my question.

Jon Patton: I was just wondering if you could provide.

Jon Patton: A little bit more color on the potential design of a pivotal study.

Jon Patton: In metastatic breast cancer with pillar obviously.

Jon Patton: Youre going to be meeting with the agency soon but just curious just generally speaking sort of.

Jon Patton: What that design could look like thanks.

Jon Patton: Yeah.

Matthew C. Coffey: Thanks, Jon. 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' Yeah, Hi Jon.

Speaker Change: Thanks, John.

Speaker Change: Push Tom under the bus on this one.

Matthew C. Coffey: And it's interesting because I'm not sure. If you saw the destiny six results that came out yesterday, because that certainly have bearing on what's Fortunately, we were able to flag with the type C meeting with the agency.

Matthew C. Coffey: And then very loosely we could talk about comparable studies that I think would be basically modeled on our we've modeled on.

Speaker Change: I'm going to ask questions at that time I'd be happy to help you out.

Thomas C. Heineman: Yeah. Hi Jon.

Jon Patton: Yeah, Hi, John so.

Thomas C. Heineman: So, um... 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 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 6 results, which are expected shortly, will help shape the future standard of care for metastatic breast cancer patients who fail hormonal therapy.

Thomas C. Heineman: As we mentioned we will be meeting with the.

Thomas C. Heineman: FDA to discuss some of the key elements of our next breast.

Thomas C. Heineman: Breast cancer study and among those key elements will be the population and Thats, what Matt was referring to is that we will we want to make sure that the.

Thomas C. Heineman: Population.

Thomas C. Heineman: Evaluate in our next study is the most relevant population from the perspective of the of the current and future standard of care.

Thomas C. Heineman: For these patients right and so the destiny six results.

Thomas C. Heineman: Which are expected shortly.

Thomas C. Heineman: Will help shape the.

Thomas C. Heineman: The future standard of care in.

Thomas C. Heineman: <unk> metastatic breast cancer patients, who failed hormonal therapy and so we want we are.

Thomas C. Heineman: 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 early registration of telomere disorders in this population.

Thomas C. Heineman: Have anticipated that and will we will have a specific discussion with the agency about the.

Thomas C. Heineman: Most appropriate population, we also plan to discuss some of the other key elements of the study design, including the primary endpoint.

Thomas C. Heineman: And the.

Thomas C. Heineman: The statistical plan in general and as we mentioned in the.

Thomas C. Heineman: In our talk earlier, our goal is to design a study that is.

Thomas C. Heineman: <unk> flexible as quick as possible and that offers the potential.

Thomas C. Heineman: For an early registration of <unk> in this population.

Speaker Change: Great. Thank you.

Thomas C. Heineman: Okay.

Thomas C. Heineman: Yes.

Operator: Your next question is from the line of Rahul Sarugesar from Raymond James; please go ahead.

Thomas C. Heineman: Your next question is from the line of Rahul <unk> from Raymond James. Please go ahead.

Rahul Sarugesar: Hey, Matt, Kirk, Tom, this is Mike on for Revolt today. Congratulations on the action packed quarter.

Operator: Hey, Matt Kurt Tom This is Mike gone through a whole today congratulations on the on the action packed quarter.

Matthew C. Coffey: I have a question on the interaction between the two pancreatic cancer trials, the you know, congratulations on announcing your green light on the M. Fulfironox trial. I'm I'm curious about the, I guess, your go forward plan with these two trials in mind. You know, the cohort one trial seems to be more advanced than the latter. I'm curious about your staging that you have in mind in respect to registration for those two trials.

Rahul Sarugesar: Question on the interaction between the two pancreatic cancer trials.

Matthew C. Coffey: Congratulations on announcing your green light.

Matthew C. Coffey: Your next trial.

Matthew C. Coffey: I'm curious about the I guess.

Matthew C. Coffey: Your go forward plan with these two trials in mind.

Matthew C. Coffey: Yes.

Matthew C. Coffey: Cohort one.

Matthew C. Coffey: Trial, it seems to be there is more advanced than the latter.

Matthew C. Coffey: I'm curious about your staging.

Matthew C. Coffey: You have in mind in respect to registration for those two trials.

Matthew C. Coffey: Okay.

Matthew C. Coffey: Mike, great question, and I'm glad you asked it because I think there's some confusion around why we would like to pursue both first-line studies. What we're finding from goblets is the earlier the patient... the more robust the T-cell response. So when we look at, you know, pancreatic, they had by far the strongest T-cell response.

Matthew C. Coffey: Mike Great question, and I'm glad you asked that because I think there is some confusion around why we would pursue both first line studies.

Matthew C. Coffey: What we're finding from goblets as the earlier the patient.

Matthew C. Coffey: The more robust is the T cell response, so when we look at pancreatic they had bye bye.

Matthew C. Coffey: By far the strongest T cell response.

Matthew C. Coffey: Anal in the second line had the next, and by the time we got the third line colorectal, there's, we met the success criteria, but there's more of a muted T-cell response. 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 immunotherapies become more and more in effect with each round of treatment. So we did want to stay in the first line setting.

Matthew C. Coffey: And the second line.

Matthew C. Coffey: By the time, we get to third line colorectal. There's we met the success criteria, but there is more of a mute. The T cell response. So we wanted to say in the first line setting and there is a really nice paper by Jim Allison that just came out talking about how.

Matthew C. Coffey: Immunotherapy has become more and more of an effect, but 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.

Matthew C. Coffey: Patients with pancreatic cancer, even in the first line setting, can be quite variable. Older patients, patients with adjuvant therapy tend to get NABPAC with Daxultrin and Cytabine 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, and we combined that based on results that we'd had with Cytabine and NABPAC with Daxultrin in the past, and I think it did very, very well in that study.

Matthew C. Coffey: Older patients.

Matthew C. Coffey: Patients adjuvant therapy.

Matthew C. Coffey: Tend to get Nab Paclitaxel I'll jump quite a bit 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 and we combine that based on results that we had had with decitabine paclitaxel in the past.

Matthew C. Coffey: I think did very very well with that study.

Matthew C. Coffey: Interestingly, those patients were given GEM and NABPAC with Daxultrin because I think almost a third of them had received Folfirinox or modified Folfirinox in the quote-unquote adjuvant phase. But we're not entirely sure it was really the adjuvant phase in the sense that it seemed that they had unclear margins, so they were almost like second-line patients. Also, those patients had a lot of liver mass, so they were an entirely appropriate patient population to get GEM, NABPAC, and Trio T-centric because they were more heavily appreciated and tend to have more burdensome disease. In this second study, it is randomized to modified Folfirinox plus or minus tesolizumab.

Matthew C. Coffey: Interestingly those patients were given.

Matthew C. Coffey: Jim Nab Paclitaxel.

Matthew C. Coffey: Because I think almost a third of them had received pop aeronautics or modified PA and the quote unquote adjuvant phase.

Matthew C. Coffey: But we're not entirely sure it was really the adjuvant phase in the sense that.

Matthew C. Coffey: It seem that the easy ahead unclear margin so they're almost like second line patient also those patients had a lot of liver Mets they were an entirely appropriate patient population to guests.

Matthew C. Coffey: Now real teeth.

Matthew C. Coffey: Because they were more heavily appreciate it and tend to have more programs some disease.

Matthew C. Coffey: With the second study.

Matthew C. Coffey: It is randomized two modified pulp here or not.

Matthew C. Coffey: Or minus <unk> <unk>.

Matthew C. Coffey: Our expectation here is that these patients will have much higher organ reserves, will have less pretreatment, and hopefully less liver metastasis, so we can go in there and treat much more aggressively, and it'll be much easier to characterize the role that we're seeing for T-centric. But looking at the results we've seen before, T-centric 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 fewer exhaustion markers in the presence of T-centric.

Matthew C. Coffey: Our expectation here these patients will have much higher Oregon reserve.

Matthew C. Coffey: Pre treatment and hopefully less liver metastasis. So we can go in there and create much more aggressively and it'll be much easier characterized the role that we're seeing for <unk> centric.

Matthew C. Coffey: But looking at the results we've seen before.

Matthew C. Coffey: T centric doesn't hamper the inflammatory response, we do see greater numbers of NK and T cells in the presence of teeth centric and we get a lot less exhaustion markers.

Matthew C. Coffey: So, we do expect the modified Folfirinox Pella arm to be successful, but we really do expect to see tremendous activity with the addition of T-centric because they just work so well hand-in-hand. And by addressing both groups, hopefully, we will become the standard of care for all first-line patients and pancreatic cancer irrespective of their pre-treatment histories or organ reserve. Tom, did you want to add anything?

Matthew C. Coffey: In the presence of T centric, so we do expect that.

Tom: Modified Paul for Aeronautics Palo arm to be successful.

Tom: But we really do expect to see tremendous activity with the addition of two centric because they just work so well hand in hand.

Tom: And by addressing both groups hopefully we become the standard of care for all first line patients and pancreatic irrespective of their pre treatment histories or Oregon Reserve.

Matthew C. Coffey: Tom did you want to add.

Thomas C. Heineman: Yeah, no, no, I think that covers it. I think the bottom line is that by exploring Pell and in combination with both of these, 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 the best option for all pancreatic cancer patients.

Tom: Yes, no no I think that covers it.

Thomas C. Heineman: The bottom line is it by <unk>.

Thomas C. Heineman: Exploring <unk> in combination with both of the <unk>.

Thomas C. Heineman: Backbone chemotherapies that are commonly used in this population it provides an opportunity to treat the ultimately the broadest range of patients and to give physicians the most flexibility possible.

Thomas C. Heineman: Best option for all pancreatic cancer patients.

Matthew C. Coffey: Okay, very helpful. And quickly, on the data that you seek to present at ASCO coming up, this Phase 1-2 trial with demptyl purinox, I'm curious from where this data derives and what maturity level of data we should expect here, and I guess the data cutoff date you might be presenting to us.

Speaker Change: Okay very helpful and then quickly on.

Matthew C. Coffey: The data that you presented at Astro coming up.

Matthew C. Coffey: This phase one two trial with dental paradox I'm curious the.

Matthew C. Coffey: From where the state of drives and maturity of data should we expect here.

Matthew C. Coffey: And I guess the data cutoff date.

Matthew C. Coffey: We might be you might be presenting the data.

Thomas C. Heineman: Yeah, so just to be clear, the poster presentation that we'll have at ASCO related to the modified Fulfironox study is a trial-in-progress poster in which we outline 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. Got it. Thanks for clarifying. I'll pass it on.

Speaker Change: Yes, so just to be clear the.

Thomas C. Heineman: The poster presentation that we'll have at <unk> related to the modified fulfill <unk> study is a trial in progress poster and which we outline the details of the study.

Speaker Change: Is currently.

Thomas C. Heineman: Well, we'll at that time be currently enrolling right. So there will be no data from that study presented at <unk> at this meeting.

Speaker Change: Okay got it thanks for clarifying I'll pass it on.

Thomas C. Heineman: Okay.

Thomas C. Heineman: Okay.

Thomas C. Heineman: Okay.

Thomas C. Heineman: Yeah.

Thomas C. Heineman: Operator, is there another question? Operator.

Thomas C. Heineman: Operators are another question.

Thomas C. Heineman: Operator.

Thomas C. Heineman: Yes.

Thomas C. Heineman: Okay.

Thomas C. Heineman: Yeah.

Thomas C. Heineman: Okay.

Thomas C. Heineman: Okay.

Matthew C. Coffey: Well, if there are no further questions, I just want to thank everyone for participating in today's call and for following athletics development. We're optimistic about the potential for Pella 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. Thanks so much.

Speaker Change: Well if there's no further questions I just wanted to thank everyone for participating in today's call and for following <unk> development. We are optimistic about the potential propeller 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. Thanks, so much.

Matthew C. Coffey: Yes.

Matthew C. Coffey: Okay.

Matthew C. Coffey: Okay.

Matthew C. Coffey: [music].

Matthew C. Coffey: Okay.

Matthew C. Coffey: Yes.

Matthew C. Coffey: Yes.

Matthew C. Coffey: [music].

Matthew C. Coffey: Okay.

Matthew C. Coffey: Yes.

Matthew C. Coffey: Thanks.

Matthew C. Coffey: Yes.

Matthew C. Coffey: Sure.

Matthew C. Coffey: Yes.

Matthew C. Coffey: Okay.

Matthew C. Coffey: Okay.

Matthew C. Coffey: Okay.

Matthew C. Coffey: Okay.

Matthew C. Coffey: Now.

Matthew C. Coffey: Yes.

Matthew C. Coffey: Yes.

Matthew C. Coffey: Right.

Matthew C. Coffey: Yes.

Matthew C. Coffey: [music].

Matthew C. Coffey: Yes.

Matthew C. Coffey: [music].

Matthew C. Coffey: Okay.

Matthew C. Coffey: Sure.

Matthew C. Coffey: Yes.

Matthew C. Coffey: Okay.

Matthew C. Coffey: [music].

Matthew C. Coffey: Okay.

Matthew C. Coffey: Okay.

Matthew C. Coffey: [music].

Matthew C. Coffey: Yes.

Matthew C. Coffey: [music].

Speaker Change: Thank you.