Q2 2024 Oncolytics Biotech Inc Earnings Call
Operator: Good afternoon, and welcome to Oncolytics Biotech's second quarter 2024 conference call. All participants are now in a 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.
Speaker Change: Good afternoon and welcome to Oncolytics Biotech's second quarter 2024 conference call. All participants are now in a listen-only mode.
Speaker Change: 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.
Jon Patton: Thank you, operator. Earlier today, Oncolytics issued a press release providing recent operational highlights and financial results for the second quarter of 2024. A replay of today's call will be available on the event section of the Oncolytics website. And 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 Pellet Rehab, including statements regarding the company's mission, strategy, and milestones, the company's belief as to the potential and mechanism of action of Pellet Rehab as a cancer therapeutic, our belief that we are positioned to execute on our key priorities and reach multiple milestones throughout the second half of the year and into 2025, our potential registrational opportunities for Pellet Rehab, anticipated timing of the release of additional data, our cash runway, and other statements related to anticipated developments in the company's business.
Speaker Change: Thank you, Operator. Earlier today, Oncolytics issued a press release providing recent operational highlights and financial results for the second quarter of 2024. A replay of today's call will be available on the events section of the Oncolytics website.
Speaker Change: And after remarks from company management, we will open the call for Q&A.
Speaker Change: 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 Pella Readerette.
Speaker Change: including statements regarding the company's mission, strategy, and milestones, the company's belief as to the potential and mechanism of action of Pell-A-Virac as a cancer therapeutic, our belief that we are positioned to execute on our key priorities and reach multiple milestones throughout the second half of the year and into 2025.
Speaker Change: Our potential registrational opportunities for Palo Verde are up, the anticipated timing of the release of additional data are cash-friendly, and other statements related to anticipated developments in the company's business.
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 risk, delays, uncertainties, and other factors not under the company's control that may cause actual results, performance, or achievements of the company to be materially different from the results, performance, or expectations implied by these forward-looking statements. In any forward-looking statement in which Oncolytics expresses an expectation or belief as a future result, such expectations or beliefs are expressed in good faith, and our beliefs have a reasonable basis, but there can be no assurance that the statement, expectation, or belief will be achieved.
Speaker Change: These statements are based on management's current expectations and beliefs, and are subject to a number of factors which involve known and unknown risk, delays, uncertainties,
Speaker Change: and other factors not under the company's control.
Speaker Change: 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.
Oncologist: 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, expectation, or belief will be achieved.
Jon Patton: These factors include results of current or pending clinical trials associated with intellectual property protection, financial projections, actions of 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, except as required by applicable law. Joining me to discuss the substantial progress made during the second quarter are a few members of the management team, including Chair of Oncolytics Board of Directors and Interim CEO Wayne Pisano; Chief Medical Officer, Dr. Tom Heineman; Chief Financial Officer, Kirk Look; Vice President, Business Development, Christophe DuBois. And with that, it's my pleasure to turn the call over to Wayne.
Oncologist: These factors include results of current or pending
Speaker Change: Financial Projections, Actions for 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 except as required by applicable laws.
Wayne Pisano: Joining me to discuss the substantial progress made during the second quarter are a few members of the management team, including Chair of Oncolytics Board of Directors and Interim CEO Wayne Pisano,
Speaker Change: Chief Medical Officer, Dr. Tom Heineman, Chief Financial Officer, Kirk Look, Vice President of Business Development, Christophe DeGlois, and with that, it's my pleasure to turn the call over to Wayne. Wayne?
Wayne Pisano: Thank you, Jon. Good afternoon.
Wayne Pisano: Thank you, Jon. Good afternoon. I appreciate everyone taking the time to join us today.
Wayne Pisano: I appreciate everyone taking the time to join us today. In the interim, the board and I are highly confident in our tenured executive team's ability to continue executing our mission, achieve our strategic priorities, and deliver on our long-term goals, and ultimately bring Pello Rio Rep to patients with cancer. Following my brief introduction, Tom will provide an update on clinical advancements, and Christoph will discuss recent collaborations and partnership opportunities.
Wayne Pisano: Well, I know you are accustomed to our CEO , Matt Coffey, leading these presentations. Personally, and on behalf of the board, I'd like to wish Matt a swift recovery.
Wayne Pisano: In the interim, the board and I are highly confident in our tenured executive team's ability to continue executing our mission, achieve our strategic priorities, and deliver on our long-term goals, and ultimately bringing Pello Rio Rep to patients with cancer.
Wayne Pisano: Following my brief introduction, Tom will provide an update on the clinical advancements.
Christoph: Christoph will discuss recent collaborations and partnership opportunities.
Christoph: Kirk will review the financials, and finally, we will end by taking your questions.
Wayne Pisano: In the second quarter of 2024, we continue to make excellent progress in advancing our potentially leading immunotherapeutic agent, Pella-RioRep, or Pella, as we often refer to it. Notably, we held an extremely productive type C meeting with the FDA, and we are able to communicate what we consider to be the optimal path for pellet and breast cancer going forward. With input from the agency, we were able to align our key elements for the next steps we plan to take, and we are bolstered by compelling data from two randomized breast cancer studies showing the benefit of Pella combined with Paxil-Taxel compared with Paxil-Taxel monotherapy.
Tom: In the second quarter of 2024, we continue to make excellent progress in advancing our potentially leading immunotherapeutic agent, Pella-RioRep, or Pella, as we often refer to it.
Tom: We believe we are well positioned to execute on our key priorities and reach multiple milestones for the second half of the year and into 2025.
Speaker Change: Now, before Tom provides a comprehensive update on our progress and how recent activities continue our mission to improve the lives of people with cancer, I would like to highlight a few important advancements.
Speaker Change: Notably, we held an extremely productive type C meeting with the FDA and we are able to communicate what we consider to be the optimal path for pellet and breast cancer going forward.
Tom: With input from the agency, we were able to align our key elements for the next steps we plan to take and are bolstered by compelling data from two randomized breast cancer studies showing the benefit of Pella combined with Paxil-Taxel compared with Paxil-Taxel monotherapy.
Wayne Pisano: This gives us confidence and tells us the potential to demonstrate a clinically meaningful benefit in a future registration-enabling study. Importantly, we remain on track to report overall survival results from the Bracelet-1 trial in the second half of 2024. This represents an exciting opportunity to evaluate the combination of Pella with another first-line pancreatic cancer chemotherapy regimen that could result in a second registration program in this indication. As you may recall, this opportunity came about as a result of positive data demonstrating that the combination of Pella and That data set not only garnered fast-track designation from the FDA, but it also brought us to our collaboration with the Global Coalition for Adaptive Research, or GCAR, where As we near a critical inflection point in the company's growth trajectory, we are encouraged by recent regulatory and clinical progress and look forward to building on this momentum.
Tom: This gives us confidence and tells us potential to demonstrate a clinically meaningful benefit in a future registration-enabling study.
Tom: Importantly, we remain on track to report overall survival results from the Bracelet-1 trial in the second half of 2024.
Speaker Change: Looking at the opportunity in pancreatic cancer, we dosed the first patient in the Modified Sulfuronox Cohort of the Goblet Study.
Speaker Change: This represents an exciting opportunity to evaluate the combination of Pella with another first-line pancreatic cancer chemotherapy regimen that could result in a second registration program in this syndication.
Speaker Change: As you may recall, this opportunity came about as a result of positive data demonstrating that the combination of PELA
Speaker Change: Tizolizumab, Gemcitabine, and Neopaklitaxel in pancreatic cancer patients more than doubled the tumor response rates compared to the response rates for chemotherapy treatment alone.
Speaker Change: That data set not only garnered fast-track designation from the FDA, but it also brought us to our collaboration with the Global Coalition for Adaptive Research, or GCAR.
Speaker Change: where this combination will be evaluated in an adaptive registration-enabling trial.
Speaker Change: As we near a critical inflection point in the company's growth trajectory, we are encouraged by the recent regulatory and clinical progress and look forward to building on this momentum.
Speaker Change: I would now like to turn the call over to Tom to provide a more detailed update. Tom?
Tom: Thank you, Wayne. As a reminder, Pella is an intravenously-delivered immunotherapeutic agent that acts systemically.
Thomas Heineman: inducing anti-cancer immune responses and promoting an inflamed tumor phenotype that is turning cold tumors hot. This allows the anti-tumor immune cells induced by PELA to attack the cancer. We have exciting data and other indications, like anal cancer, that could eventually lead to additional registrational opportunities. But for today, we'll just focus on breast and pancreatic cancer. In June, we provided a recap of our Type C meeting with the FDA. We had a very productive and helpful discussion with the agency that provided valuable guidance on our proposed registration-enabling study.
Tom: inducing anti-cancer immune responses and promoting an inflamed tumor phenotype that is turning cold tumors hot. This allows the anti-tumor immune cells induced by Pella to attack the cancer.
Tom: As Wayne mentioned, we are currently focused on advancing pellet toward registrational studies in breast and pancreatic cancer.
Speaker Change: We have exciting data and other indications, like anal cancer, that could eventually lead to additional registrational opportunities, but for today, we'll just focus on breast and pancreatic cancer.
Speaker Change: Starting with our breast cancer program, I'd like to touch on two topics.
Speaker Change: a recent productive Type C meeting with the FDA, and the anticipated Bracelet-1 study survival results.
Speaker Change: In June , we provided a recap of our Type C meeting with the FDA. We had a very productive and helpful discussion with the agency that provided valuable guidance on our proposed registration-enabling study.
Thomas Heineman: One perhaps underappreciated takeaway was that the FDA endorsed progression-free survival as the primary endpoint of the study, with overall survival as the secondary endpoint, and could save substantial development time by allowing us to reach the potential registrational endpoint sooner. The patient population for the registrational study is anticipated to include patients who have failed hormonal therapy and have received no more than one line of antibody drug conjugate therapy. I should also mention that we have translational data from the AWARE-1 study that provided valuable insights into Pella's immune-mediated mechanism of action, including its ability to remodel the tumor microenvironment. Aligning with the FDA on key design elements and objectives of our planned registrational trial marks a critical step toward bringing this innovative treatment to patients. As a reminder, Bracelet 1 is a Phase 2 randomized study in patients with HR-positive, Patients in Cohort 1 received Paclitaxel, which served as the control arm.
Speaker Change: One, perhaps, underappreciated takeaway was that the FDA endorsed progression-free survival as the primary endpoint of the study, with overall survival as a secondary endpoint.
Speaker Change: Having progression-free survival as the primary endpoint mirrors the path taken by Pfizer for the initial approval of iBrands based on the PLOMA I study and could save substantial development time by allowing us to reach the potential registrational endpoint sooner.
Speaker Change: The patient population for the registrational study is anticipated to include patients who have failed hormonal therapy and have received no more than one line of antibody drug conjugate therapy.
Speaker Change: Our de-risked Brett's cancer program builds on compelling data and key learnings from two prior randomized studies, Bracelet 1 and IND213, which demonstrated clinically meaningful benefit in patients who were treated with Pella and Paclitaxel compared to Paclitaxel alone.
Speaker Change: I should also mention that we have translational data from the AWARE-1 study that provided valuable insights into Pella's immune-mediated mechanism of action, including its ability to remodel the tumor microenvironment.
Speaker Change: Aligning with the FDA on Key Design Elements and Objectives of our Planned Registrational Trial.
Speaker Change: marks a critical step toward bringing this innovative treatment to patients.
Speaker Change: Next, I'd like to move on to the anticipated Bracelet-1 survival data.
Speaker Change: As a reminder, Bracelet 1 is a Phase 2 randomized study in patients with HR-positive, HER2-negative metastatic breast cancer.
Speaker Change: The study enrolled 48 patients into three cohorts. Patients in Cohort 1 received Paclitaxel, which served as the control arm. Patients in Cohort 2 received Paclitaxel plus Pella. And patients in Cohort 3 received Paclitaxel, Pella, and the checkpoint inhibitor of Valiumab.
Speaker Change: We previously reported strong tumor response and progression-free survival results from the Bracelet1 study.
Speaker Change: These included a near tripling of the confirmed overall response rate, a greater than 50 percent improvement in median progression-free survival, and a hazard ratio of 0.29 for patients receiving Pella and Paclitaxel compared to Paclitaxel alone.
Speaker Change: Overall survival results have not yet been reported due to ongoing patient follow-up but are anticipated later this year.
Speaker Change: As noted, the earlier IND213 study showed a statistically 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 Change: A strong overall survival readout in the Pella-paclitaxel arm in the BRACE-01 study will serve to further validate these earlier findings and support continuing discussions with potential strategic partners and regulators.
Thomas Heineman: Patients in Cohort 2 received Paclitaxel plus Pella, and patients in Cohort 3 received Paclitaxel, Pella, and the checkpoint inhibitor, Oxalumin. Now, turning to our Pancreatic Cancer Program, I'd like to start by highlighting our new Goblet Study Cohort, which is supported by a $5 million Therapeutic Accelerator Award from the Pancreatic Cancer Action Network, or PANCAM. PanCan launched the Therapeutic Accelerator Award to speed up pancreatic cancer drug development so new therapies could be made available to patients sooner.
Speaker Change: Now, turning to our Pancreatic Cancer Program, I'd like to start by highlighting our new Goblet Study Cohort, which is supported by a $5 million Therapeutic Accelerator Award from the Pancreatic Cancer Action Network, or PANCAM.
Speaker Change: PanCan launched the Therapeutic Accelerator Award to speed up pancreatic cancer drug development so new therapies could be made available to patients sooner.
Speaker Change: By way of background, the Goblet Study is a Phase I-II signal finding study in advanced or metastatic gastrointestinal cancers.
Thomas Heineman: The study is being conducted across 17 centers in Germany and is being managed by AIO, a medical oncology working group within the German Cancer Society. To date, we have evaluated Pella in first-line metastatic pancreatic ductal adenocarcinoma, or PDAC. Third-line metastatic colorectal cancer, and second-line or later, anal cancer, in June. We announced the dosing of the first patient in our new Goblet Study cohort, evaluating Pella combined with modified fulfirinox, with or without atezolizumab, a newly diagnosed metastatic PDAC patient.
Speaker Change: The study is being conducted across 17 centers in Germany and is being managed by AIO, a medical oncology working group within the German Cancer Society.
Speaker Change: To date, we have evaluated Pella in first-line metastatic pancreatic ductal adenocarcinoma, or PDAC.
Speaker Change: Third-line metastatic colorectal cancer, and second-line or later, anal cancer.
Speaker Change: In each of these indications, the Pella-based combination therapy met the pre-specified success criteria.
Speaker Change: Pancreatic cancer has one of the lowest survival rates among all cancers and is the third leading cause of cancer mortality in the U.S. Despite its growing incidence, efforts to improve upon the standard of care have met with limited success over the past several years.
Speaker Change: In June , we announced the dosing of the first patient in our new Goblet Study cohort, evaluating Pella combined with modified fulfirinox, with or without atezolizumab, in newly diagnosed metastatic PDAC patients.
Thomas Heineman: This study utilizes an assignment two-stage design, and the co-primary endpoints are objective response rate and safety. The chemotherapy regimens of modified fulfirinox and gemcitabine abpaclitaxel are the two most common standards of care in metastatic pancreatic cancer. We previously reported that the combination of Pella, gemcidabine mapactlitaxel, and atezolizumab, Well, we believe there's an exciting opportunity for Pella combined with modified fulfinum. I would like to briefly mention our two presentations at this year's ASCO meeting.
Speaker Change: This study utilizes assignment two-stage design and the co-primary endpoints for objective response rate and safety.
Speaker Change: If Stage 1 success criteria are met, one or both treatment arms may be expanded to Stage 2, in which 17 additional evaluable patients per arm would be enrolled.
Speaker Change: The chemotherapy regimens of modified fulfirinox and gemcitabine abpaclitaxel are the two most common standards of care in metastatic pancreatic cancer.
Speaker Change: We previously reported that the combination of Pella,
Speaker Change: yielded tumor response rates more than double the historical results.
Speaker Change: Should the combination of Pella and modified fulfirinox also produce a positive outcome, it would indicate that an even broader range of metastatic PDAC patients may benefit from Pella-based therapy.
Speaker Change: Importantly, this treatment regimen could result in another registrational opportunity for pellet in this challenging indication.
Speaker Change: Well, we believe there's an exciting opportunity for Pella combined with modified fulfirinox.
Speaker Change: Our immediate registrational strategy in PDAC continues to focus on Pella combined with atezolizumab, gemcitabine, and nabpaclitaxel.
Speaker Change: based on the very positive results from the GOBLET study. We continue to collaborate with GCAR to design a study utilizing an adaptive approach to evaluate this combination therapy, and we look forward to providing an update as our plans are finalized.
Speaker Change: Before I turn the call over to Christophe, who will discuss our GCAR collaboration in more detail...
Speaker Change: I would like to briefly mention our two presentations at this year's ASCO meeting.
Speaker Change: Details of the trial design for our new Goblet Study pancreatic cancer cohort, in which Pellis combined with modified fulfirinox were presented.
Speaker Change: Additionally, we presented an abstract detailing Pella's ability to induce the expansion of tumor-infiltrating lymphocytes, or TILs, across multiple cancers including breast, pancreatic, and colorectal cancer.
Speaker Change: Pella's ability to expand till populations is important because till expansion correlates with tumor response.
Speaker Change: These data further highlight Pella's immunotherapeutic mechanism of action and its promise as a backbone immunotherapy for multiple cancer indications.
Speaker Change: Taken together, we are extremely excited about the advancements across our pipeline and the growing body of clinical data showcasing Pella's broad therapeutic potential.
Speaker Change: With that, I will turn the call over to Christoph, who is joining us for the first time on a financial results call. He will be heading up our business development efforts going forward and is here to discuss our recent collaborations and partnership opportunities.
Speaker Change: Christoph
Christoph: Thank you, Tom. I'm excited to join the team and see a real opportunity for Pella and Oncolytics to make an impact in the treatment of cancer, so I'm thrilled to be here.
Speaker Change: In the second quarter, we enter into a preliminary collaboration with GCAR, which we believe underscores the strength of the growing Pella dataset that continues to attract and pique the interest of the clinical oncology community.
Christophe DuBois: of the Clinical Oncology Committee. GCAR is a non-profit corporation uniting physicians, clinical researchers, advocacy and philanthropic organizations, biotech pharma companies, health authorities, and other key stakeholders in health care. GCAR's objective is to expedite the discovery and development of treatments for patients with rare and deadly diseases. As a sponsor of innovative trials, including master protocols and adaptive platform trials, GCAR is dedicated to the advancement of science by modernizing clinical trials that support more efficient, less costly drug development.
Speaker Change: GCAR is a non-profit corporation uniting physicians, clinical researchers, advocacy and philanthropic organizations, biotech pharma companies, health authorities, and other key stakeholders in health care.
Speaker Change: GCAR's objective is to expedite the discovery and development of treatment for patients with rare and deadly diseases.
GCAR: As a sponsor of innovative trials, including master protocols and adaptive platform trials, GCAR is dedicated to the advancement of science by modernizing clinical trials that support more efficient, less costly drug development.
Speaker Change: We are pleased to partner with GCAR and are honored that Pella has been selected as the first therapeutic for evaluation in their planned adaptive trial in pancreatic cancer patients.
Speaker Change: So the selection process was thorough and involved meeting with and presenting our clinical data to multiple pancreatic cancer key opinion leaders.
GCAR: We are working together to finalize a Phase II-III master protocol design that will evaluate Pella and other investigational therapies for the treatment of pancreatic cancer.
GCAR: GCAR's anticipated trial design seeks to cut registrational study time and reduce trial costs, speeding up the journey to potentially deliver effective cancer treatment sooner.
Christophe DuBois: This strategy, which includes leveraging JICA's extensive Investigator Network, offers a cost-effective opportunity to enhance our ability to quickly and effectively advance the development of this Pella-based combination therapy for metastatic pancreatic cancer, a disease with a very high medical need and limited treatment options. Beyond GCAR, we intend to continue to seek strategic opportunities to collaborate and maximize the therapeutic and commercial potential of TELA.
GCAR: This strategy, which includes leveraging JICA Extensive Investigator Network,
GCAR: offers a cost-effective opportunity to enhance our ability to quickly and effectively advance the development of this Pella-based combination therapy for metastatic pancreatic cancer, a disease with a very high medical need and limited treatment options.
GCAR: Beyond GCAR, we intend to continue to seek strategic opportunities to collaborate and maximize the therapeutic and commercial potential of TELA.
GCAR: We have an ongoing dialogue with current and potential collaborators and believe additional data updates will continue to strengthen our value proposition.
GCAR: I will now turn the call over to Kirk to review the financial results for the second quarter of 2024.
Kirk Look: Thanks, Christophe, and good afternoon, everyone. We continue to be cognizant of our cash resources and make the necessary investments to progress Pella's development while ensuring we have funds needed to reach critical milestones. As of June 30, 2024, the company reported $24.9 million in cash and cash equivalents, with a projected cash runway into 2025. The change reflected non-cash working capital changes, partly offset by higher net operating activities in 2024 and higher share-based compensation expenses.
GCAR: Kirk
Kirk: Thanks Christophe, and good afternoon everyone. I'd like to briefly run through our financial results for the second quarter of 2024, which will be provided in Canadian dollars unless otherwise noted.
Kirk: 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.
GCAR: We continue to be cognizant of our cash resources and make the necessary investments to progress Pella's development while ensuring we have funds needed to reach critical milestones.
GCAR: As of June 30, 2024, the company reported $24.9 million in cash and cash equivalents, with a projected cash runway into 2025.
GCAR: Net cash used in operating activities for the six months ended June 30, 2024 was $14.3 million, compared to $16.3 million for the six months ended June 30, 2023.
GCAR: The change reflected non-cash working capital changes, partly offset by higher net operating activities in 2024.
GCAR: Now general and administrative expenses for the second quarter of 2024 were $3.4 million, consistent with $3.5 million for the second quarter of 2023.
GCAR: Research and development expenses for the second quarter of 2024 were $4.6 million, compared to $3.7 million for the second quarter of 2023.
GCAR: The increase was primarily due to higher clinical trial expenses, including Bracelet1 data analysis and the GCAR collaboration.
GCAR: and higher share based compensation expenses.
GCAR: The increase was partly offset by lower production run and process analytical development activities in manufacturing.
GCAR: The net loss for the second quarter of 2024 was $7.3 million, compared to a net loss of $7.4 million for the second quarter of 2023.
GCAR: The basic and diluted loss per share was $0.10 per share in the second quarter of 2024, compared to a basic and diluted loss per share of $0.12 in the second quarter of 2023.
Wayne Pisano: Now, this is an exciting time for the company, and as we conclude today's call, I would like to highlight a few critical events that we believe move us closer to our ultimate goal of regulatory approval for Pella. In the second quarter of 2024, we continue to propel Pella towards registration and labeling studies in breast and pancreatic cancer. In summary, we received productive feedback from the Type C meeting with the FDA for our planned registration-enabling trial for Pella and HR-positive or 2-negative metastatic breast cancer and expect to provide further guidance on the path forward in the second half of the year as an immunotherapeutic agent and potential to improve the lives of people with cancer. Before we conclude today's call, I would like once again to thank the entire Oncolytics team, our investors, and the many people who are supporting us along the way, including our patients and their families.
GCAR: Now this is an exciting time for the company.
GCAR: And as we conclude today's call, I would like to highlight a few critical events that we believe move us closer to our ultimate goal of regulatory approval for Pella. In the second quarter of 2024, we continue to propel Pella towards registration enabling studies in breast and pancreatic cancer.
GCAR: We established a strategic collaboration with GCAR and continue to have productive discussions with key opinion leaders, our clinical collaborators, and regulators.
GCAR: In summary,
GCAR: We received productive feedback from the Type C meeting with the FDA for our planned registration-enabling trial for Pella and HR-positive, HER2-negative metastatic breast cancer, and expect to provide further guidance on the path forward in the second half of the year.
GCAR: We continue following patients from the Bracelet 1 Breast Cancer Study and remain on schedule to report overall survival data in the second half of this year.
GCAR: We entered into a collaboration with GCAR for inclusion of Pella in an adaptive registration-enabling pancreatic cancer trial and expect to finalize the master protocol for Pella, gemcidabine, nabpaclitaxel, and atezolizumab in the second half of 2024.
GCAR: With our collaborators, we then plan to initiate the Adaptive Registration Enabling Trial in the first half of 2025.
GCAR: We dosed the first patient in the new Goblet-Modified Fulfironox pancreatic cancer cohort, supported by funding from PanCan, which could result in another registrational opportunity for Pella.
GCAR: We expect to report a safety run-in update in the second half of the year.
GCAR: Taken together, we believe our robust, positive clinical and translational data support PELLIS-MOA as an immunotherapeutic agent and potential to improve the lives of people with cancer.
GCAR: Before we conclude today's call, I would like once again to thank the entire Oncolytics team, our investors, and the many people who are supporting us along the way, including our patients and their families.
Speaker Change: With that, we are happy to take questions. Operator?
Speaker Change: Thank you. Ladies and gentlemen, we will now begin the question and answer session. Should you wish to ask a question, please press star followed by number 1 on your telephone keypad.
Speaker Change: You will hear a prompt that your hand has been raised. And should you wish to cancel your request, please press star followed by the number 2. And if you're using a speakerphone, please lift your handset before pressing any keys.
Operator: Please lift your handset before pressing any keys. Once again, press stars and 1 if you wish to ask a question. And we will now take our first question. This comes from the line of Louise Chen from Cantor. Please go ahead.
GCAR: Once again, star and one if you wish to ask a question.
Speaker Change: And we will now take our first question. This comes from the line of Louise Chen from Canter. Please go ahead.
Carvey On: Hi, good afternoon everyone. This is Carvey On for Louise from Kanner.
Speaker Change: Hi, good afternoon everyone. This is Carvey On for Louise from Canter. Thanks for taking our questions.
Carvey On: Thanks for taking our questions. First, can you remind us of the size of the commercial opportunity for Pella and HR plus for two minus metastatic breast cancer? And second, what would your registration trial design look like? Thank you.
Speaker Change: First, can you remind us of the size of the commercial opportunity for Pella and HR Plus?
Speaker Change: for 2-Metastatic Breast Cancer, and second, what would your registration trial design look like? Thank you.
Speaker Change: Thanks for the questions, Kirby. First, I'll turn it over to Christophe to speak to
Christophe DuBois: Yes, hi. Yeah, I mean, as you may know, this is a very changing environment with, obviously, you know, some ADCs, N02 in particular, you know, making some, obviously, some changes to a lot of this market based on recent data. So we're currently in the process of updating the commercial opportunity, and I think on the next call we'll be able to provide more detail. There's still a significant commercial opportunity if you think about the way N02 is going to be used in these patients.
Christophe: Speak to the market.
Christophe: Yes, hi. Yeah, I mean, as you may know, I mean, this is a very changing environment with obviously, you know, some ADCs.
Speaker Change: I know two in particular, you know, making some, obviously some changing a lot this market.
Speaker Change: based on recent data. So we're currently in the process of updating the commercial opportunity and I think in the next call we'll be able to provide more detail. There's still a significant commercial opportunity if you think about the way NO2 is going to be used in these patients.
Christophe DuBois: Obviously, you know, they're going to, they're not approved yet, but I think it's very likely that they would come, you know, right after, you know, the hormonal therapy. But unfortunately, as you know, this patient will still relapse.
Speaker Change: Obviously, you know, they are going to, they are not approved yet, but I think it's very likely that they would come, you know, right after, you know, the hormonal therapy. But unfortunately, as you know, this patient will still relapse.
Speaker Change: and you need a subsequent line of treatments and we believe you know there's a significant commercial opportunity in in order to failures
Christophe DuBois: And I'll ask Tom to respond to the plan.
Speaker Change: And I'll ask Tom to respond to the plan.
Tom: Yes, so we um
Tom: Expect to move forward with our next trial in the form of a registration enabling large
Tom: Phase 2 study.
Speaker Change: with a primary endpoint of progression-free survival and in the population that Christoph actually described, which is patients who have either failed
Speaker Change: Antibody Drug Conjugate Therapy following progression on hormonal therapy or patients for whom Antibody Drug Conjugate Therapy is inappropriate or who cannot tolerate such agents.
Speaker Change: So we, and this study would...
Speaker Change: would allow us, with two opportunities to win...
Speaker Change: If it meets a high level of significance,
Speaker Change: For the investigational arm, it would put us in the position of applying for an accelerated approval, and at a very minimum, it would substantially de-risk any subsequent trial that we
Speaker Change: would conduct to confirm the efficacy of the combination therapy.
Speaker Change: Great. Thank you so much.
Speaker Change: Thank you. And the next question comes from the line of John Newman from Canaccord. Please go ahead.
Speaker Change: Heather, thanks for taking my question.
John Newman: Excuse me, I also had a question about the registration enabling study for Pell Rerub in breast cancer.
Thomas Heineman: I'm assuming that most of the patients, if not all the patients enrolling in the study, will have previously been treated with an ADC. Is there any specificity as to which ADC? And then the second question that I had was just in terms of the geography of the study; would this be primarily a U.S.-based study, or would you also include patients from Europe?
Thomas Heineman: potentially is a portion of patients being treated with ADC as the only major variable difference between bracelet one and phase two, three, or do you see others? And just could there be a difference between bracelet and phase 2-3?
John Newman: I'm assuming that most of the patients, if not all the patients, enrolling in the study will have previously been
Speaker Change: treated with an ADC. Is there any specificity as to which ADC? And then the second question that I had was just in terms of the geography of the study, would this be primarily a U.S.-based study or would you also include patients from Europe ?
Speaker Change: Yeah, so Jon, I can, I'm here, I can comment on that. So, I think the, as Christophe said, the
Speaker Change: Treatment approach in patients as it relates to the antibody drug conjugates is still evolving, right, so I don't think anyone can say with precision exactly.
Speaker Change: What proportion of patients in our study would have failed antibody drug conjugate therapy? But I think it's very, very reasonable to assume that the majority of them would have received antibody drug conjugate therapy. There will be patients who are not appropriate for antibody drug conjugate therapy.
Speaker Change: or who take it for a short period of time and cannot tolerate it. You know, so there will be patients who come into the study through other pathways.
Speaker Change: But, at present, the data that are available
Speaker Change: In the population we're looking at, it would suggest that the antibody drug conjugate therapy that would be most in play, that is to say the therapy that patients would have failed before coming into our study, would be in HER2.
Speaker Change: Right, that's the agent for which the data currently exists, suggesting a solid benefit immediately following the failure of hormonal therapy.
Speaker Change: This study, we would anticipate that this study would have a substantial enrollment in North America, of course, and we're currently evaluating possible other
Speaker Change: Geography for enrollment, it seems reasonable to expect that there would be sites in some of the major Western European countries, for example, and beyond that we need to consider our options.
Speaker Change: Okay, thank you.
Speaker Change: Thank you. And the next question comes from the line of Soumit Roy from Jones Research. Please go ahead.
Sumit Roy: Good afternoon, everyone.
Sumit Roy: Possibly a question for Tom. The bracelet one trial...
Sumit Roy: Have you discussed p-value or was it too small of a cohort size? And second question is, for the phase 2-3 registration trial in breast cancer, do you expect...
Speaker Change: potentially is a portion of patients being treated with ADC as the only major variable difference between bracelet one and the phase 2-3 or do you see other changes could be there, differences between bracelet and the phase 2-3?
Speaker Change: Yes, so we have the P-value for the PFS comparison.
Speaker Change: Okay and the and the and the comparison the p-value for the comparison between paclitaxel and the paclitaxel plus pellet rear rib arm was 0.03 so it was less significant at less than the 0.05
Speaker Change: [inaudible]
Speaker Change: And with regard to...
Speaker Change: The differences in the bracelet population, yes, I mean, I think you're right. We would be enrolling patients in this study, as discussed already, who have failed ADC therapy, which were not enrolled in bracelet, because they simply did not exist at that time.
Speaker Change: But otherwise, the patient population would be essentially identical to the bracelet patient population.
Speaker Change: A quick follow-up, do you expect to do any sub-analysis to separate out those patients with prior ADC in Phase 2-3 or?
Speaker Change: Well, we haven't, you know, so we haven't, we haven't formalized our analysis plans to that level, but I'm, I'm sure that we would be looking at any distinctions between significant population groups within any, any randomized study.
Thomas Heineman: Thank you again, and congratulations on the program.
Speaker Change: Thank you again and congrats on the program.
Speaker Change: Thank you.
Speaker Change: Thank you. And the next question comes from the line of Michael Akamewicz from Maxim Group. Please go ahead.
Michael Akamewicz: Hey guys, thank you for taking my questions today.
Michael Akamewicz: I just want to see if you can help clarify the nature of the additional registrational opportunity.
Speaker Change: that you're saying could emerge from Cohort 5 of the Goblet Study. Is there an expectation here that you could file for accelerated based on that data, or are you referring to the ability to launch a second registrational study based on that data?
Thomas Heineman: Yes, so the data that we're generating in Cohort 5 of the Goblet Study, we view that as a kind of signal-finding, proof-of-concept data. We would not expect that those data would support, in and of themselves, an accelerated approval. However, as you know, we are planning to move forward with the other combination, Pella plus gemcitabine NAPAC with Haxel through the collaboration with GCAR, which would be a registrational approach. And it is certainly possible.
Speaker Change: Yes, so the data that we're generating in Cohort 5 of the Goblet Study
Speaker Change: We view that as a kind of signal-finding, proof-of-concept.
Speaker Change: Data, we would not expect that those data
Speaker Change: would support in and of themselves an accelerated approval, however, as you know, we are planning to move forward with the other combination, the
Speaker Change: The Pella plus the Gemcitabine NAPAC with Haxel through the collaboration with GCAR, which would be a registrational approach. And it is certainly possible.
Speaker Change: If the Cohort 5 results look...
Speaker Change: good and turn out the way we hope and expect they will, that that combination could be evaluated, for example, in a platform study such as what we're doing with GTAR already or through some other mechanism.
Speaker Change: All right. Thank you. That's very helpful. And then one other for me, and I'll hop back in the queue. I wanted to see if you had any expectations on the size of the potential pivotal study in breast cancer that you'd need based on the prior PFS data that you haven't had for Payla in this setting. Thank you.
Speaker Change: Yeah, what we're looking at, I mean, the model that we're following is very similar to the approach that was used by Pfizer, for example, for their initial licensure of iBrands and then subsequently by Daiichi for the initial licensure of Inhertu. So what we'd be looking at would be a study of
Thomas Heineman: Sub 200 patients, 180, 200 patients, somewhere in that order of magnitude.
Speaker Change: sub 200 patients, 180-200 patients, somewhere in that order of magnitude.
Thomas Heineman: Alright, thank you very much, and I'm wishing for a speedy recovery for Matt.
Speaker Change: Yeah, thanks. Thank you.
Speaker Change: Thank you. And the next question comes from the line of Rahul Sarugasar from Raymond James. Please go ahead.
Rahul Sarugaser: Good afternoon, gents. Thanks so much for taking our questions, and also I'll just reiterate Jason's point about wishing a speedy recovery for Matt.
Christophe DuBois: But also, following up on Jason's question, talking about the, you know, now that you're through the type C meeting and you're looking at setting up the breast cancer trial.
Speaker Change: These patients are effectively going to be second, third line after
Speaker Change: So, perhaps you can give us a sense of your confidence on patient recruitment, the number of sites you'll need to be able to fill the study, and how fast you think you'll be able to recruit, given that we think that this can be a relatively competitive patient group.
Speaker Change: Well, I mean, I think that in the...
Christophe DuBois: We are not planning to compete with NR2, right? We would be coming in and recruiting patients who can either not receive NR2, for example, or who have failed NR2, right? And for those groups...
Speaker Change: We are not planning to compete with INHERTU. We would be coming in and recruiting patients who can either not receive INHERTU, for example, or who have failed INHERTU. And for those groups,
Speaker Change: That's helpful, really. Thank you very much. That's very helpful. And now, just as a follow-on, pivoting to the Goblet Study and Pan-Can.
Speaker Change: Yeah, Raul, thanks for the question.
Raul: As we see the GPR study, the first part of the adaptive design study readout,
Speaker Change: What we do find interesting on the Cohort 5, on the goblet side of things with the modified Folfirinox combination,
Speaker Change: and I'll take advantage of that data and those results when they come out and then we'll start to obviously outreach towards partners at that time. That said, though, prior to...
Christophe DuBois: Prior to that data coming out, we will have, and things are progressing as expected on the bracelet, overall survival analysis. And so that's happening much quicker. And so we'll be looking to perform some meaningful outreach with that information in hand, subject to the results earlier than what we see out of the pancreatic cancer cohort.
Raul: and things are progressing as expected on the bracelet.
Raul: overall survival analysis and so that's you know happening much quicker and so we'll be looking to
Raul: to perform some meaningful outreach with that information in hand, subject to the results earlier than what we see out of the pancreatic cancer cohorts.
Speaker Change: Thank you.
Raul: Thank you. That concludes the Q&A session for today. I will now hand back the call to Kirk Look. Please go ahead, sir.
Kirk Look: Well, thank you everyone, and for all that are participating in today's call, and for your interest in oncolitics development. We continue to be passionate about improving cancer treatment options for patients.
Raul: I'll end our prepared remarks by wishing everyone a great evening. Thanks very much.
Speaker Change: Thank you. This concludes our conference for today. Thank you all for participating. You may now disconnect your lines.