Q4 2023 Oncolytics Biotech Inc Earnings Call

March 7, 2024

Operator: Good afternoon, and welcome to Oncolytics Biotech's fourth quarter and full year 2023 conference call. All participants are now in a listen-only mode.

Good afternoon, and welcome to uncle detects biotechs fourth quarter and full year 2023 conference call.

All participants are now in a listen only mode.

Operator: 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 conference call over to Jon Patton, Director of Investor Relations and Communication. Please go ahead.

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 conference call over to John Patten Director of Investor Relations and Communications. Please go ahead.

Thank you operator, and good afternoon, everyone earlier today.

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 fourth quarter and full year of 2023. 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'll 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 Pella RE-REP, including statements regarding the company's mission, strategy, and objectives, the company's belief as to the potential mechanism of action, and benefits of Pella RE-REP as a cancer therapeutic, our clinical development plans for 2024, including initiation of our first registrational studies for Pella RE-REP, a manufacturing program, our cash runway, and other statements relating to anticipated developments in the company's business.

Issued a press release, providing recent operational highlights and financial results for the fourth quarter and full year of 2023, a replay of today's call will be available on the events section of the 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 contains certain forward looking statements relating to the companys business prospects and the development and commercialization of Callaway Europe, including statements regarding the company's mission strategy and objectives. The companys beliefs as to the potential mechanism of action and benefits of pellet catcher therapeutics a.

Our clinical development plans for 2024, including initiation of our first Registrational studies for telling me.

Manufacturing program, our cash runway and other statements related to anticipated developments and the company's business. These statements are based on management's current expectations and beliefs and are subject to a number of factors, which involve known and unknown risks delays uncertainties and other factors not under the company's control that may cause actual results performance or achievements of the company to be.

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 to future results, such expectations or beliefs are expressed in good faith and are believed to have a reasonable basis. There can be no assurance that the statement, expectation, or belief will be achieved.

Different from the results performance or expectations implied by these forward looking statements.

And any forward looking statement in which expresses an expectation or belief as to future results such expectations or beliefs are expressed in good faith I believe kind of is a reasonable basis. There can be no assurance that these statements expectation or belief will be achieved.

Jon Patton: These factors include results of current or pending clinical trials, risks associated with intellectual property production, financial projections, actions by regulatory agencies, and those 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. The Oncolytics management team is on the call today to review our fourth quarter 2023 and year-end results, including Chief Executive Officer, Dr. Matt Coffey, Chief Financial Officer, Kirk Look, Chief Medical Officer, Dr. Tom Heineman, and Vice President, Product Development, Allison Hagerman. Now, I will turn the call over to Dr. Coffey. Matt.

These factors include results of current or pending clinical trials risks associated with intellectual property protection for intra projections actions by regulatory agencies.

Factors detailed in the company's filings with SEDAR and the SEC.

So it's not undertake any obligation to update these forward looking statements, except as required by applicable laws.

Yes. Thanks management team is on the call today to review, our fourth quarter 2023, and year end results, including Chief Executive Officer, Dr. Matt Coffey, Chief Financial Officer, Kirk look Chief Medical Officer, Dr. Tom Heinemann, and Vice President product development, Allison Hagerman now I will turn the call over to Dr. Coffey.

Matt. Thank you John Good afternoon, and welcome to the Oncologic biotech fourth quarter conference call.

Matthew C. Coffey: Thank you, Jon. Good afternoon, and welcome to the Oncolytics Biotech fourth quarter conference call. 2024 marks the year that Oncolytics will become a late-stage cancer company with the initiation of our first registrational studies for our proprietary immunotherapeutic product candidate, Pella-Rarep, or Pella, as we'll refer to it. This brings us closer to achieving our mission of improving the lives of patients with cancer. So we'll begin the year with significant enthusiasm.

2024 months of the year that analytics will become a late stage cancer company with the initiation of our first Registrational studies for our proprietary immunotherapy.

Pudic product candidate, Colorado, Rep or pillar of what we started with.

This brings us closer to achieving our mission of improving the lives of patients with cancer.

We began the year with significant enthusiasm.

Matthew C. Coffey: The transition to becoming a late stage biopharma company reflects significant progress and positive clinical and translational data reported from our clinical programs in 2023. A key element of this transition is making smart investments in manufacturing, which is why Allison Hagerman will join us to talk about the steps we're taking so Oncolytics is set up for success as Pelham is closer to beginning the registrational trial. During our call today, we would like to share some of the key highlights from the last several months, outline our clinical and strategic objectives for 2024, including manufacturing, review our financial results for the fourth quarter and full year 2023, and take your questions. Positive clinical and translational data helped close 2023 on a high note. Starting with our clinical results, we reported positive clinical data from three cohorts in the Phase 1-2 Goblet Study in pancreatic cancer, colorectal cancer, and anal cancer. Each indication achieved the predefined quote-unquote Stage 1 success criteria, defined according to the Simon 2-stage study design.

The transition to becoming a late stage Biopharma company and reflects significant progress and positive clinical and translational data reported from our clinical programs in 2023.

A key element of this transaction is making smart investments in manufacturing, which is why Allison Hagerman will join us to talk about the steps. We're taking for athletic is set up for success as pelon those closer to beginning Registrational trials.

During our call today, we would like to share some of the key highlights from the last several months.

Outline of clinical and strategic objectives for 2024 included in manufacturing.

Review, our financial results for the fourth quarter and full year 2023 and take your questions.

Positive clinical and translational data help to close 2023 on a high note.

Starting with our clinical results, we reported positive clinical data from three cohorts in the phase <unk> study in pancreatic cancer colorectal cancer and anal cancer. Each indication has achieved the pre defined quote unquote stage one success criteria.

According to the Simon two stage study design.

Matthew C. Coffey: In addition, data from the Pancreatic and Anal Cancer Cohorts demonstrated response rates that were nearly three times greater than published historical controls. Additionally, positive clinical results were supported by valuable translational data from further analysis of the AWARE-1 breast cancer study and from cohorts in the GOBLET study. These data underscore Pella's mechanism of action as an immunotherapeutic agent. Importantly, the data demonstrated a positive correlation between response rates and pellet's ability to induce the expansion of the T cell population, measured by increases in the spell till score and the level of tumor infiltrating lymphocytes or TILs in the peripheral blood. Kale expansion could become an important biomarker of clinical outcomes that could be used in future clinical studies and to guide patient care.

In addition data from the patriotic in ammo cancer cohorts demonstrated response rates that were nearly three times greater than published historical controls.

Positive clinical results were supported by valuable translational data from further analysis of the aware one breast cancer study and from cohorts in the study.

These data underscore appellate mechanism of action asking immuno therapeutic agents.

Importantly, the data demonstrated a positive correlation between response rates and <unk> ability to induce the expansion of T cell populations measured by increases in the cell til score and the level of tumor infiltrating lymphocytes Fort Hills in the peripheral blood.

He'll expansion could become an important biomarker and clinical outcomes that could be used in future clinical studies and to guide patient care.

Matthew C. Coffey: Positive data that we reported throughout 2023, including the Bracelet-1 breast cancer data reported in June, have also attracted interest and enhanced ongoing interactions with our clinical collaborators and potential strategic partners. The overall survival data for Bracelet1 continues to mature for patients receiving Pella and Paclitaxel. Overall, survival is an important metric to potential partners and will likely serve as the catalyst to further our ongoing business development conversations. Additionally, these conversations have further informed our thinking on the design of future registrational studies. We've sharpened our strategic thinking thanks to the contributions of our board of directors, including our new director, Pat Andrews. Her experience in navigating registrational trials in oncology and completing transformational business development agreements complements and expands the strategic expertise of our board. We look to extend this transformational and strategic mindset in all of our discussions in 2024 and beyond.

The positive data that we reported throughout 2023 include the bracelet one breast cancer data reported in June have also attracted interest enhanced ongoing interactions with our clinical collaborators and potential strategic partners.

The overall survival data for bracelet, one continues to mature for patients receiving pella paclitaxel.

Overall survival is an important metric to potential partners, who will likely serve as a catalyst to further our ongoing business development conversations.

Additionally, these conversations have further informed our thinking on the design of future Registrational studies.

We have sharpened our strategic thinking thanks to the contributions of our board of directors, including our New director Pat Andrew.

Her experience in navigating registrational trials in oncology and completing transformational business development agreements complements and expands the strategic expertise of our board.

We'd like to extend the transformational and strategic mindset in all of our discussions in 2024 and beyond.

Now as we look ahead, we are steadfast in our focus on achieving important objectives. This year, then with pella forward on the regulatory pathway.

Matthew C. Coffey: Now, as we look ahead, we are steadfast in our focus on achieving important objectives this year that move Pella forward on the regulatory pathway. These include, in the first half of the year, we intend to provide guidance on a registrational path for pellet and breast cancer. Also, in 2024, we plan to initiate a registration study for pellet and pancreatic cancer using an adaptive design. I'd like to take a moment to expand on our thinking for each indication, starting with breast cancer. We expect our registrational strategy in breast cancer to focus on an evaluation of Pella in combination with Paclitaxel compared to Paclitaxel monotherapy in patients with metastatic disease who are ATR-positive or HER2-negative.

These include in the first half of the year, we intend to provide guidance on a registrational path from pellet in breast cancer.

Also in 2024, we plan to initiate a registration study for <unk> in pancreatic cancer Ethernet adaptive design.

I'd like to take a moment to expand on our thinking for each indication starting with breast cancer.

We expect our Registrational strategy in breast cancer to focus on an evaluation of <unk> in combination with paclitaxel compared to Paclitaxel monotherapy in patients with metastatic disease, who are HR policies or her two negative.

As a reminder, we are continuing to follow patients in the bracelet, one HR positive <unk> negative metastatic breast cancer study and expect to report overall survival data this year.

Matthew C. Coffey: As a reminder, we are continuing to follow patients in the Bracelet-1, HR-positive, HER2-negative metastatic breast cancer study and expect to report overall survival data this year. That being said, the data we've reported so far is supportive of the statistically significant near doubling of median overall survival seen in the IND213 study. With respect to our plans for pancreatic cancer, we expect our registration study to focus on the evaluation of Pella in combination with epidilizumab, gemcitabine, and nabpaclitaxel compared to the combination of gemcitabine and nabpaclitaxel in patients receiving first-line treatment for pancreatic ductal adenocarcinoma, or PDAC. We continue to develop a study protocol that utilizes an adaptive design building on the positive results from the Goblet Study.

Being said the data we've reported so far are supportive of the statistically significant near doubling that median overall survival seen in the <unk> III study.

With respect to our plans for pancreatic cancer, we expect our registration study to focus on the evaluation of <unk> in combination with a feudalism add gemcitabine and Nab paclitaxel compared to the combination of Gemcitabine and Nab Paclitaxel in patients receiving first line treatment for pancreatic ductal adenocarcinoma or PD.

Okay.

We continue to develop our study protocol that utilizes at adaptive design building on the positive results from the study.

The Registrational strategy for P data will incorporate learnings from our previous interactions with the pancreatic cancer action network Pan.

Pan Ken and ongoing conversations with our newly announced alliance partner the global coalition for adaptive research or G card.

As a result of these relationships, we've been able to collaborate with key opinion leaders in the pancreatic cancer community and their enthusiasm for pellet potential in this indication reinforces our commitment to bringing new treatment options to patients.

Matthew C. Coffey: The registrational strategy for PDAC will incorporate learnings from our previous interactions with the Pancreatic Cancer Action Network, also known as PANCAN, and ongoing conversations with their newly announced alliance partner, the Global Coalition for Adaptive Research, or GCAR. As a result of these relationships, we've been able to collaborate with key opinion leaders in the pancreatic cancer community, and their enthusiasm propels potential, and this indication reinforces our commitment to bringing new treatment options to patients. I'd also like to mention the expansion of the enrollment in the Goblet Cohort focused on anal cancer. The American Cancer Society estimates that there will be about 10,500 new cases of this cancer in 2024. We recently announced plans to begin enrolling stage two of this cohort based on positive results in the first stage of the Simon Two-Stage Program, reported at an international medical meeting in November of last year.

I'd also like to mention the expansion into enrollment in the Gaba cohort focused on anal cancer.

The American cancer Society estimates that there will be about 10500, new cases of cancer in 2024.

We recently announced plans to begin enrolling stage two of this cohort based on positive results in the first stage of the Simon two stage program reported at an international medical meeting in November of last year.

We will evaluate the combination of pillar and a teaser list about in patients with second line or later disease.

While in a cancer is very rare there is no standard of care for these patients who have progressed to advanced disease. So positive result may provide an opportunity for a rapid regulatory pathway. We hope to report additional data in 2025.

Before I turn the call over to Tom assignment. There are three key messages, we would like you to take away from today's call.

First and foremost propelled by the encouraging clinical and translational data we unveiled in 2023.

Matthew C. Coffey: The study will evaluate the combination of Pella and atezolizumab in patients with second-line or later. While inter-cancer is very rare, there is no standard of care for these patients who have progressed to advanced disease, so positive results may provide an opportunity for a rapid regulatory pathway. We hope to report additional data in 2025. Before I turn the call over to Tom Heineman, there are three key messages we would like you to take away from today's call.

<unk> is poised to embark on registrational trials for pancreatic cancer and breast cancer as early as 2024.

The consistently positive outcomes from seminal studies, such as bracelet, one aware, one and goblet cell capture the attention and deepen engagement at the clinical oncology community and potential strategic partners.

Secondly, we eagerly anticipate the forthcoming release of overall survival data from the bracelet, one breast cancer study in 2024.

Matthew C. Coffey: First and foremost, propelled by the encouraging clinical and translational data we unveiled in 2023, Pella is poised to embark on registrational trials for pancreatic cancer and breast cancer as early as 2024. The consistently positive outcomes from seminal studies such as Bracelet1, Aware1, and Goblet have captured the attention and deepening engagement of the clinical oncology community and potential strategic partners. Secondly, we eagerly anticipate the forthcoming release of overall survival data from the Bracelet-1 breast cancer study in 2024. This data represents an important milestone anticipated to serve as a significant catalyst in bolstering our registration efforts for Pella and a focal point of interest for our prospective biopharma collaborators. Lastly, the compelling data stemming from the anal carcinoma cohort of the Goblet Study advocates for the expansion of this cohort. With the potential for fewer than 20 additional patients to be enrolled, we could swiftly transition toward a registrational study in this critical unmet need area.

This data represents an important milestone anticipated to serve as the significant catalysts at bolstering our registration endeavors propeller and a focal point of interest for our prospective biopharma collaborators.

Lastly, the compelling data stemming from the anal carcinoma cohort the goblet study advocate for the expansion of this cohort.

With the potential for fewer than 20 additional patients to be enrolled we could swiftly transition towards a registrational study in this critical unmet need area, particularly noteworthy is the distinctive approach of excluding chemotherapy and fever in favor of leveraging that demonstrated synergy between pella and a checkpoint inhibitor underscoring our commitment to pioneering.

Novel and effective treatment modalities.

Finally, as always I'd like to thank everyone in the athletics organization and our collaborators for your dedication to the mission to improve the care of patients with cancer you work to advance the development of pellet inspires me and everyone around us everyday Tom.

Thanks, Matt.

Matthew C. Coffey: Particularly noteworthy is the distinctive approach of excluding chemotherapy in favor of leveraging the demonstrated synergy between Pella and a checkpoint inhibitor, underscoring our commitment to pioneering novel and effective treatment modalities. Finally, as always, I'd like to thank everyone in the Oncolytics organization and our collaborators for your dedication to the mission to improve the care of patients with cancer. Your work to advance the development at Pella inspires me and everyone around us every day. Tom.

During todays call I'd like to provide a snapshot of the key features of pillar.

An update on our ongoing clinical programs.

It is administered intravenously, which allows it to work systemically by selectively infecting tumor cells wherever they may be in the patient.

Some tumor cells are killed directly by co infection and.

In other cases co infection results in the accumulation of double stranded RNA in the cancer cells.

This induces a pro inflammatory response in the tumor micro environment.

So tumor for immunologic Kelly.

Specifically co infection results, an increase T cell infiltration into the tumor <unk>.

Thomas C. Heineman: Thanks, Matt. During today's call, I'd like to provide a snapshot of the key features of Pella and an update on our ongoing clinical program. Pella is administered intravenously, which allows it to work systemically by selectively infecting tumor cells wherever they may be in the patient. Some tumor cells are killed directly by pellet infection. In other cases, pellet infection results in the accumulation of double-stranded RNA in the cancer cell.

Expansion of tumor infiltrating lymphocytes also known as <unk>.

And stimulation of both technique and adaptive immune responses.

We can assess the immuno therapeutic action of pillar II clinical effects, such as changes in tumor size.

To disease progression and overall survival. In addition, we can assess the immunologic effects with pellet treatment by such measures as the expansion of kills in the blood.

Thomas C. Heineman: This induces a pro-inflammatory response in the tumor microenvironment that primes the tumor for immunologic killing. Specifically, pell infection results in increased T-cell infiltration into the tumor, expansion of tumor-infiltrating lymphocytes, also known as TILs, and stimulation of both innate and adaptive immune responses. We can assess the immunotherapeutic action of Pella through clinical effects, such as changes in tumor size, time to disease progression, and overall survival. In addition, we can assess the immunologic effects of Pella treatment by such measures as the expansion of kills in the blood. Data demonstrating a positive correlation between clinical response and TIL expansion support the potential use of this measure as a biomarker in future clinical trials and during patient care. In 2023, Oncolytics provided important clinical and translational data from the Bracelet1 study, from multiple Gobleth study cohorts, and from the Aware1 study.

Data demonstrating a positive correlation between clinical response until expansion support the potential use of this measure as a biomarker in future clinical trials and during patient care.

In 2023, <unk> provided important clinical and translational data from the bracelet one study for multiple goblet study cohorts.

From the aware one study.

Based on these results I will take you through our clinical plan.

For 2024.

As Matt indicated this year, we expect to provide guidance on a registrational plans for pellet in breast cancer to initiate a registrational study of <unk> in.

In pancreatic cancer and report the overall survival results from the bracelet, one breast cancer study.

In addition, we plan to initiate a new pancreatic cancer cohort in the gamba.

The new cohort will evaluate pillar plus modified fulfill remarks with or without a <unk> and.

In patients with newly diagnosed metastatic pancreatic cancer. This new cohort will be supported by the $5 million Pan can therapeutic accelerator grant and has been submitted to the German regulatory authorities. We also will expand enrollment into the angel.

Thomas C. Heineman: Based on these results, I will take you through our clinical plan for 2024. As Matt indicated, this year, we expect to provide guidance on a registrational plan for Pella and breast cancer, initiate a registrational study of Pella and pancreatic cancer, and report the overall survival results from the Bracelet-1 breast cancer study. In addition, we plan to initiate a new pancreatic cancer cohort in the Goblet study. The new cohort will evaluate Pella plus modified fulfirodox with or without apizolizumab in patients with newly diagnosed metastatic pancreatic cancer.

Carcinoma arm of the study.

Now I'd like to add a few additional comments on the <unk> breast cancer data the new pancreatic cancer cohort in the goblet study and the expansion of the Goblet study <unk> carcinoma cohort.

We continue to follow a bracelet one study patients for survival. The last patient enrolled in the study will reach two years of follow up in 2024.

Once this milestone is reached with.

With survival results will be analyzed and we will expect to report these results by the end of the year.

As Matt mentioned, we also expect to provide an update on our registrational plans for breast cancer in the first half of this year.

Thomas C. Heineman: This new cohort will be supported by the $5 million PanCan Therapeutic Accelerator Grant and has been submitted to the German regulatory authorities. We will also expand enrollment into the anal carcinoma arm of the GOBLET study. Now I'd like to add a few additional comments on the BRACEL1 breast cancer data, the new pancreatic cancer cohort in the GOBLIP study, and the expansion of the GOBLIP study anal carcinoma cohort. We continue to follow hundreds of one study patients for survival.

The progression free survival results already reported from Bruce with one are consistent with the near doubling of immediate overall survival seen in the earlier RMB 213 breast cancer.

Your study.

They support the possible use of progression free survival as the primary end point in the future Registrational breast cancer study, which will reduce the time required to complete the primary study analysis.

Moving to the goblet study, the new pancreatic cancer cohort and which we will evaluate the combination of core plus modified fulfill remarks with or whats now the <unk> is.

Thomas C. Heineman: The last patient enrolled in the study will reach two years of follow-up in 2024. Once this milestone is reached, the survival results will be analyzed, and we will expect to report these results by the end of the year. As Matt mentioned, we also expect to provide an update on our registrational plans for breast cancer in the first half of this year. The progression-free survival results already reported from Bracelet-1 are consistent with the near doubling of median overall survival seen in the earlier IND213 breast cancer study.

This is expected to begin enrollment in the coming months.

We are enthusiastic about this new cohort because it will enable us to study <unk> in combination with one of the most widely used pancreatic cancer treatment back end.

And to directly assess the value of adding a checkpoint inhibitor we.

We are very grateful and encouraged by the support we received from <unk> to conduct this study pan candidates an important voice in the pancreatic cancer community and our work with them as lead to valuable relationships with key leaders in this field.

Moreover, their belief in the potential of pillar provides additional validation of our efforts in this indication positive results from this study could expand the population of pancreatic cancer patients who may benefit from pillar based therapy in.

Thomas C. Heineman: Furthermore, they support the possible use of progression-free survival as the primary endpoint in a future registrational breast cancer study, which would reduce the time required to complete the primary study analysis. Moving to the Goblet Study, the new pancreatic cancer cohort in which we will evaluate the combination of Pella plus modified fulfirinox with or without tesolizumab is expected to begin enrollment in the coming months. We are enthusiastic about this new cohort because it will enable us to study Pella in combination with one of the most widely used pancreatic cancer treatment backbones and to directly assess the value of adding a checkpoint inhibitor. We are very grateful and encouraged by the support we received from PanCan to conduct this study. PanCan is an important voice in the pancreatic cancer community, and our work with them has led to valuable relationships with key leaders in this field.

And may ultimately provide physicians with much needed treatment options for this devastating disease.

We expect to begin enrollment into this study cohort in the coming months.

Before closing.

I'd like to talk about the enrollment expansion of the goblet anal carcinoma cohort.

In which patients are being treated with the combination of pillar <unk> and without any chemotherapy.

In November of 2023.

We reported encouraging preliminary results from this cohort, namely a 37, 5% objective response rates compared to historical results for checkpoint inhibitors alone of 10% to 14%.

Just on this we have decided to expand enrollment into this cohort.

An additional 18 evaluable patients.

And we plan to add more study sites to reduce the enrollment time.

We believe potential Biopharma partners and have a keen interest in this cohort because of the limited benefit provided by checkpoint inhibitor monotherapy, which is commonly used in second line or later <unk> carcinoma patients.

Thomas C. Heineman: Moreover, their belief in the potential of Pella provides additional validation of our efforts in this indication. Positive results from this study could expand the population of pancreatic cancer patients who may benefit from Pella-based therapy and may ultimately provide physicians with much-needed treatment options for this devastating disease. We expect to begin enrollment into this study cohort in the coming months.

Furthermore, the promising preliminary results from this cohort.

<unk> ability to synergize with checkpoint inhibitors and enhanced their efficacy cancers, where they've historically provided little benefit.

This study could open the door to an additional registrational pathway for pillar and an indication with a clear medical need.

Finally, I would like to express our appreciation to the patients.

Study site staff and investigators who participated in our clinical studies.

We are very grateful to you for making these research efforts possible.

Thomas C. Heineman: I'd like to talk about the enrollment expansion of the Goblet Anal Carcinoma Cohort, in which patients are being treated with a combination of Pella and tesolizumab and without any chemotherapy in November of 2023. We reported encouraging preliminary results from this cohort, namely a 37.5% objective response rate compared to historical results for checkpoint inhibitors alone of 10 to 14%. Based on this, we have decided to expand enrollment into this cohort by an additional 18 valuable patients, and we plan to add more study sites to reduce the enrollment time.

As you can tell 2024 will be a year rich and clinical activities and I look forward to updating you on our progress as the year unfolds.

Next up is Matt mentioned at the start of the call Alison will provide an update on our manufacturing and product development efforts Alison Thanks, Tom I'm excited to share the progress we've made over these past few months.

Matt and Tom have just shared 2024 is poised to be a very important year for <unk> as we advance <unk> Registrational study readiness.

The key elements of this advance is the cornerstone investment we will be making in the Palo product supply.

So my discussion you will hear me use the word products product supply and supply chain. These are all industry terms related to manufacturing and are not intended to generic and FDA approved products.

Thomas C. Heineman: We believe potential biopharma partners have a keen interest in this cohort because of the limited benefit provided by checkpoint inhibitor monotherapy, which is commonly used in second-line or later anal carcinoma patients. Furthermore, the promising preliminary results from this cohort support Pella's ability to synergize with checkpoint inhibitors and enhance their efficacy in cancers where they've historically provided little benefit. This study could open the door to an additional registrational pathway for Pella and an indication of a clear medical need.

I'll also use the term <unk>.

Median purified bulk polo reroute material the active pharmaceutical ingredients.

Substance is used in the manufacture of drug product. The finished dosage form package for patient administration.

Key takeaways from my section.

We have a well established product supply chain for Paula we have made numerous patches of material at increasing scale on Palo has a long shelf life we.

Thomas C. Heineman: Finally, I would like to express our appreciation to the patients, study site staff, and investigators who participated in our clinical study. We are very grateful to you for making these research efforts possible. As you can see, 2024 will be a year rich in clinical activities, and I look forward to updating you on our progress as the year unfolds. Next up, as Matt mentioned at the start of the call, Allison will provide an update on her manufacturing and product development efforts. Allison.

We have been working with a high quality contract manufacturing organization for some time.

And we are investing and optimize manufacturing scale up and validation. So that we are ready to support product registration.

For a bit of backgrounds Paulo drug substance is produced in a simple eight step process and start and bulk at minus 80 degrees Celsius.

Strength product can be stored at minus 80 or minus 20 degrees Celsius.

Allison Hagerman: Thanks, Tom. I'm excited to share the progress we've made over these past few months. As Matt and Tom have just shared, 2024 is poised to be a very important year for oncolytics as we advance Pellis to registrational study readiness. A key element of this advance is the cornerstone investment we will be making in Pella product supply. Throughout my discussion, you will hear me use the word product, product supply, and supply chain. These are all industry terms related to manufacturing and are not intended to denote an FDA-approved product. I will also use the term drug substance, meaning purified bulk tellurea rep material, the active pharmaceutical ingredient.

Hello material has a long shelf life with ongoing drug substance stability out past 10 years, plus an established drug product exploration period of six years from date of product selling.

Hello is made by our contract development and manufacturing organization, our CMO Millipore Sigma has AFC located in the San Diego area.

Master and working cell banks and virus banks are established and validated all of our materials are sourced from qualified suppliers and the process operating parameters are well defined.

We have been working with this organization, formerly known as Sigma Aldrich for more than 15 years with consistent staffing at both organizations.

The Menlo Park speaking the site has a well established quality management system, and our protocols and procedures are well aligned.

Allison Hagerman: The drug substance is used in the manufacture of drug products, the finished dosage form packaged for patient administration. Key takeaways from my section are that we have a well-established product supply chain for Pella, we have made numerous batches of material at increasing scale, and Pella has a long shelf life. We have been working with a high-quality contract manufacturing organization for some time, and we are investing in optimized manufacturing scale-up and validation so that we are ready to support product registration. For a bit of background, Pella's drug substance is produced in a simple eight-step process and stored in bulk at minus 80 degrees Celsius; finished drug product can be stored at minus 80 or minus 20 degrees. So, Pella material has a long shelf life, with ongoing drug substance stability for past 10 years, plus an established drug product expiration period of six years from date of product filling. Pellets are made by our Contract Development and Manufacturing Organization, or CDMO, Millipore Sigma SFC, located in the San Diego area. Master and working cell banks, as well as virus banks, are established and validated. All raw materials are sourced from qualified suppliers, and the process operating parameters are well defined.

In addition, the site produces GMP materials, rather organization, including commercial products and has completed nine successful inspections, including the FDA and other health authorities.

Handled numerous biologics over the years and are a leader in viral vector manufacturing. So they are familiar with assets like Palo.

Stable staffing well established quality management system and working with the <unk> that has been FDA inspected are all very important for consistency quality and risk management, which are always top of mind manufacturing.

In the fourth quarter of 2023, we initiated a new GMP production campaign with the drug substance process transition to single use equipment and scaled up to a 200 liter bioreactor.

Increasingly purified batch size to about 12 liter as a bulk drug substance.

The first GMP batch has been completed and once routine manufacturer has been established our next step will be the validation batches.

Our successful track record and scale up and consistent production gives us confidence that our investment in the next level of pellet drug substance batches will go well as we continue this work in 2024 and financial insights.

Okay.

In conjunction with the scale up we also optimize some upstream elements of the process, including a change in detergent to align with European long term guidelines.

Allison Hagerman: We have been working with this organization, formerly known as Sigma Aldrich, for more than 15 years, with consistent staffing at both organizations. The Millipore Cigna site has a well-established quality management system, and our protocols and procedures are well aligned. In addition, the site produces GMP materials for other organizations, including commercial products, and has completed nine successful inspections, including by the FDA and other health authorities. They have handled numerous biologics over the years and are a leader in biovector manufacturing. So they are familiar with assets like pellets.

Thankfully the switch won't impact the purified drug substance of our products. The detergent is cleared through the purification steps and the final pillar product concentration and formulation remains the same.

In addition to drive substance manufacturer in the fourth quarter of 2023, we also completed a second automated track product fill in our full isolate our system.

This provides a nice uptick environment for selling and high level of sterility assurance and also allows for larger quantities per loss, reducing the cost of goods.

Allison Hagerman: Stable staffing, a well-established quality management system, and working with a CDMO that has been FDA inspected are all very important for consistency, quality, and risk management, which are always top of mind in many laboratories. In the fourth quarter of 2023, we initiated a new GMP production campaign with the drug substance process transition to single-use equipment and scaled up to a 200-liter bioreactor, increasing the purified batch size to about 12 liters of bulk drug substance. The first GMP batch has been completed, and once routine manufacture has been established, our next step will be validation batches. Our successful track record in scale-up and consistent production gives us confidence that our investment in the next level of Pella drug substance batches will go well as we continue this work in 2024 and 2025.

Moving onto a few operational notes.

Very simple to ship and store at study sites, we believe a user friendly products interfaces importance and are confident that tell us that stat specification well.

Drug product single dose vials are shipped to study sites on dry ice and can be stored at minus 80 or in a minus 20 Celsius freezer.

It is straightforward to preparing for administration to patients.

From where we stand today, we have an adequate supply in place to support our current and future clinical program, including the registration enabling studies.

In conclusion <unk> has invested very carefully in our supply chain. So that we can support our clinical program and be ready to validate commercial manufacturing processes at the right time in support of future product registration, we plan to invest in manufacturing over the next year to support a registration plans for pillar.

Once we close our prepared remarks, I will be happy to take questions and I look forward to providing further manufacturing updates over the course of the year.

Allison Hagerman: In conjunction with the scale-up, we also optimized some upstream elements of the process, including a change in detergent to align with European long-term guidelines. Thankfully, this switch won't impact the purified drug substance or products. The detergent is cleared through the purification steps, and the final teleproduct concentration and formulation remain. In addition to drug substance manufacture, in the fourth quarter of 2023, we also completed a second automated drug product fill in a full isolator system. This provides an aseptic environment for filling and a high level of sterility assurance and also allows for larger quantities per lot, reducing the cost of construction. Moving on to a few operational notes. Pella is very simple to ship and store at study sites.

Now I'd like to turn the call over to Kurt to review the financial results for the last year correct.

Thanks, Alison and good afternoon, everyone.

In this segment of the call I would like to take you through 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.

Yeah.

The company closed the year with $34 $9 million in cash and cash equivalents compared to $32 million in cash cash equivalents in marketable securities as of December 31, 2022.

Allison Hagerman: We believe a user-friendly product interface is important and are confident that Pella fits that specification well. Pellidrug product single-dose vials are shipped to study sites on dry ice and can be stored at minus 80 or in minus 20 Celsius. It is straightforward to prepare a dose for administration. From where we stand today, we have an adequate supply in place to support our current and future clinical programs, including the registration-enabled study. In conclusion, Oncolytics has invested very carefully in our supply chain so that we can support our clinical program and be ready to validate commercial manufacturing processes at the right time in support of future product registries. We plan to invest in manufacturing over the next year to support our registration plans for Pellet.

We believe this will enable us to achieve the most critical near term milestones set out in todays call.

The net loss for the fourth quarter of 2023 was $3 9 million compared to $8 6 million in the fourth quarter of 2022.

According to a net loss of <unk> <unk> per share in the fourth quarter of 2023 compared to <unk> 14 cents a share for the same period of 2022.

The net loss for the full year of 2023 was $27 8 million compared.

Compared to $24 8 million in the full year 2022, equating to a net loss of 41 per share for the 'twenty three period and a net loss of 43 per share for the 2022 periods on a consolidated basis.

Kirk J. Look: Once we close our prepared remarks, I will be happy to take questions, and I look forward to providing further manufacturing updates over the course of the year. Now, I'd like to turn the call over to Kirk to review the financial results for the past year. Kirk, thanks, Allison, and good afternoon, everyone. In this segment of the call, I'd like to take you through 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. The company closed the year with $34.9 million in cash and cash equivalents compared to $32 million in cash, cash equivalents, and marketable securities as of December 31, 2022.

The net loss for the fourth quarter and full year of 2023 included gains of $4 8 million and $5 3 million, respectively, mainly related to the change in fair value warrants issued as part of our 2023 public offerings.

General and administrative expenses for the fourth quarter of 2023 were $4 2 million compared to $3 7 million for the fourth quarter of 2022.

For the full year 2023 general and administrative expenses were $16 1 million compared to $11 5 million for the full year of 2023.

The changes between the fourth quarter and full year 2023, and the respective 2022 periods were mainly due to higher investor relations activities.

Kirk J. Look: We believe this will enable us to achieve the most critical near-term milestones set out in today's call. The net loss in the fourth quarter of 2023 was $3.9 million, compared to $8.6 million in the fourth quarter of 2022, according to a net loss of $0.05 per share in the fourth quarter of 2023 compared to $0.14 a share for the same period of 2022. The net loss for the full year of 2023 was $27.8 million compared to $24.8 million in the full year 2022, equating to a net loss of 41 cents per share for the 23rd period and a net loss of 43 cents per share for the 2022 period on a consolidated basis. The net loss for the fourth quarter and full year of 2023 included gains of $4.8 million and $5.3 million, respectively, General and administrative expenses for the fourth quarter of 2023 were $4.2 million, compared to $3.7 million for the fourth quarter of 2022. For the full year 2023, general and administrative expenses were $16.1 million, compared to $11.5 million for the full year of 2022.

Our full year 2023 expenses also included a portion of our 2023 public offering transaction costs.

Now research and development expenses for the fourth quarter of 2023 were $4 7 million compared to $4 8 million for the fourth quarter of 2022.

For the full year 2023 research and development expenses were $17 7 million compared to $15 four for the full year 2022.

The changes between the fourth quarter and full year 2023, and the respective 2022 periods were driven by higher manufacturing expenses.

<unk> implementing single use equipment and scaling up our drug substance production process.

This was offset by lower costs related to our ongoing clinical studies and reduced clinical and safety data management.

Now in closing I'd like to spend a moment to elaborate on a few of Matt's comments regarding our organizational transition.

<unk> as a potential backbone immunotherapy that is sure.

Shown efficacy signals in multiple indications, we have meaningful data from over 120, metastatic HR positive her two negative breast cancer patients and 120 pancreatic cancer patients.

Notably we continue to capitalize on opportunities to further validate pellet potential through initiatives like Pan cancer Therapeutics accelerator program.

Kirk J. Look: The changes between the fourth quarter and full year 2023 and the respective 2022 periods were mainly due to higher investor relations activity. Our full year 2023 expenses also included a portion of our 2023 public offering transaction costs. Now, research and development expenses for the fourth quarter of 2023 were $4.7 million, compared to $4.8 million for the fourth quarter of 2022. For the full year 2023, research and development expenses were $17.7 million, compared to $15.4 million for the full year 2022.

Which after thorough and highly competitive process resulted in the grant of $5 million fully funding, our modified pulse paradox, Peter cohort and goblet.

There are also opportunities to broaden pillows applications indications like anal cancer, where an efficacy signal has emerged.

We've assembled a management team that is well positioned to bring pella to patients and attracting a board member like Pat Andrews reflects the strength of our team and <unk> potential.

Finally, we have fostered important relationships with organizations like Pan Ken pre cog.

Kirk J. Look: The changes between the fourth quarter and full year 2023 and the respective 2022 periods were driven by higher manufacturing expenses associated with implementing single-use equipment and scaling up our drug substance production process. However, this is offset by lower costs related to our ongoing clinical studies and reduced clinical and safety data management. Now, in closing, I'd like to spend a moment to elaborate on a few of Matt's comments regarding our organizational transition. Pella is a potential backbone immunotherapy that has shown efficacy signals in multiple indications.

And clinical collaborators like Pfizer and Roche.

Our positive clinical data is enriching our discussion with a number of current and potential clinical and strategic partners.

Before I turn the call back to Matt I'd like to note that our financial strategy and organizational development have provided us with a cash runway through critical critical milestones and into 2025.

I look forward to providing you with further updates on our transformation to a late stage oncology company throughout the year.

Matt.

Thanks, Kurt the clinical data, we reported in 2023 pillar on a clear trajectory towards registration with metastatic breast cancer and metastatic pancreatic cancer as our highest priority indications.

Kirk J. Look: We have meaningful data from over 120 metastatic, HR-positive, HER2-negative breast cancer patients and 120 pancreatic cancer patients. Notably, we continue to capitalize on opportunities to further validate Pella's potential through initiatives like PAN-CAM's Therapeutic Accelerator Program, which after a thorough and highly competitive process resulted in a grant of 5 million US dollars fully funding our modified Fulfurinox PDAC cohort in Goblet. There are also opportunities to broaden PELA's application to indications like anal cancer, where an efficacy signal has emerged. We have assembled a management team that is well positioned to bring Pella to patients, and attracting a board member like Pat Andrews reflects the strength of our team and Pella's potential. Finally, we have fostered important relationships with organizations like PANCAN, PRECOG, AIO, and clinical collaborators like Pfizer and Roche.

Our dedication to collaboration and engagement remains steadfast as we foster important discussions with the clinical oncology community with respect to strategic partners.

Together, we are committed to expediting pellet journey to markets, ensuring both swift progress and financial Prudence every step of the way.

This collective effort fuels, our optimism and drives us towards the future where pellets transformative potential composite really impact countless lives as we conclude today's call and embark on this new year, we have a bright outlook for the development of pillar and are hopeful outlook for patients with an unwavering dedication to our mission together all of US we're pioneering a path filled with hope.

The termination and the resolute belief that every step forward brings us closer to uplifting patient lives and the reshaping of landscape of cancer treatment. We look forward to updating you on our progress this year and thank you for taking the time with US today, operator, I would now like to open the call up for questions.

Thank you, ladies and gentlemen, we will now conduct the question and answer session.

Kirk J. Look: Our positive clinical data is enriching our discussions with a number of current and potential clinical and strategic partners. Before I turn the call back to Matt, I'd like to note that our financial strategy and organizational development have provided us with a cash runway through critical clinical milestones and into 2025. I look forward to providing you with further updates on our transformation to a late-stage oncology company throughout the year.

Have a question. Please press star followed by the number one on your Touchtone phone.

Here at the depot and prop acknowledging your request.

If you would like to cancel your request. Please press star two please.

Please ensure you lift the handset before pressing any keys.

Your first question comes from the line of Sumit Roy from Jones Research. Your line is now open.

Matthew C. Coffey: Thanks, Kirk. The clinical data we reported in 2023 put Pella on a clear trajectory towards registration, with metastatic breast cancer and metastatic pancreatic cancer as our highest priority in the. Our dedication to collaboration and engagement remains steadfast as we foster important discussions with the clinical oncology community and prospective strategic partners. Together, we are committed to expediting Pella's journey to markets, ensuring both swift progress and financial prudence every step of the

Good afternoon, everyone and thank you again for all the details on the progress, especially on the manufacturing front.

A quick question on the.

Breast cancer trial.

Trying to understand if.

If you expect any change in the visa.

<unk> planned patient characteristics, you placed the trial versus the <unk>.

Potential pivotal trial.

In terms of.

Hard to status or.

Companion treatment.

Any differences you expect and also on the manufacturing front.

Matthew C. Coffey: This collective effort fuels our optimism and drives us towards a future where Pella's transformative potential can positively impact countless lives. As we conclude today's call and embark on this new year, we have a bright outlook for the development of Pella and a hopeful outlook for patients, with an unwavering dedication to our mission. Together, all of us, we're pioneering a path filled with hope, determination, and the resolute belief that every step forward brings us closer to uplifting patients' lives and the reshaping of the landscape of cancer. We look forward to updating you on our progress this year, and thank you for taking the time with us today. Operator, I would now like to open the call for questions. Thank you. Ladies and gentlemen, we will now conduct a question and answer session. If you have a question, please press star followed by the number one on your touchtone phone. You will hear a three-tone prompt acknowledging your request. If you would like to cancel your request, please press star 2. Please ensure you lift the handset before pressing any keys.

As you have fairly clearly explained there is good.

Transfer of technology between prior and current.

Manufacturing.

It really is quite you guys and everything anything that could change the vital characteristics.

Any color would be appreciated.

Okay.

Yes, sure Tom behind them and here I can I can speak to the first part of your question on the breast cancer study.

The population will be very similar to the <unk> study population there will be some.

Differences.

Due to the evolving standard of care in the.

The target population in particular, the approval recently of antibody drug conjugates.

It will be.

Largely similar to the bracelet population and that it will be in patients who have <unk>.

Failed hormonal therapy, HR positive <unk> negative breast cancer patients, who have failed hormonal therapy, and who are now ready for the next stage of their treatment.

And maybe I'll, let Alison.

Operator: Your first question comes from the line of Soumit Roy from Jones Research. Your line is now open. Good afternoon, everyone, and thank you again for all the details on the progress, especially on the manufacturing front. Quick question on the...

Hey, Gordon speak to the next part of your question.

Thanks, Tom with regard to the question related to technology transfer and any change and virus characteristics. No. There are no changes to the virus characteristics of the product.

Soumit Roy: Breast Cancer Trial, trying to understand if you expect any change in the basic, baseline patient characteristics of your bracelet trial versus the potential pivotal trial in terms of how status or companion treatments will affect any differences you expect. And also on the manufacturing front, as you have fairly clearly explained, there is a good transfer of technology between prior and current manufacturing, the release criteria, and everything, anything that could change the viral characteristics of any color would be appreciated. Yeah, sure. Tom Heineman here.

The drug substance or the product the raw material input remain the same including the master and working virus, Scott and all products batches are tested including identity testing.

Potency purity and virus concentration to assure comparability.

Visibility for clinical use.

Thank you. Thank you again for taking the questions.

Sure.

Your next question comes from the line of John Newman from Canaccord. Your line is now open.

Hey, guys. Thank you for taking my question just wondering if you could.

Thomas C. Heineman: I can speak to the first part of your question on the breast cancer study. The population will be very similar to the bracelet study population. There will be some differences due to the evolving standard of care in the target population, in particular the recent approval of antibody drug conjugates, but it will be largely similar to the bracelet population in that it will be in patients who have failed hormonal therapy, HR-positive, HER2-negative breast cancer patients who have failed hormonal therapy and who are now ready for the next stage of their treatment. And maybe I'll let Allison do it.

Talk a little bit more about the design of the pivotal study in pancreatic cancer, including the potential endpoints that you could look at there. Thanks.

Hey, John It's Matt coffee.

Yes.

What we're looking at is very similar to what we initially planned with the Pan can people, it's quite an innovative design in the sense that it uses adaptive and what we really.

Thought with clever about it.

And FDA approved protocol, so they're used to the idea of an interim look in an adaptive study.

Allison Hagerman: Hey, Hagerman, speak to the next part of your question. Thanks, Tom. With regard to the question related to technology transfer and any change in virus characteristics, no, there are no changes to the virus characteristics of the product, either the drug substance or the product itself.

Im.

It allows us to more expediently get to an approval.

Obviously, a tank at the tough indication so lets us have an interim look as well to make sure that we're on the right track.

Allison Hagerman: The raw material input remains the same, including the master and working virus stops, and all products batches are tested, including identity testing, potency, purity, and virus concentration to assure comparability and suitability for clinical use. Thank you. Thank you again for taking the question. Your next question comes from the line of Jon Newman from Canaccord. Your line is now open.

Very similar to.

What you'd expect from the Pan kind of looking at that the primary endpoint would be overall survival, which is the most meaningful in this patient population.

And.

Obviously in this patient population.

Endpoint that we don't have to wait a long time to get to so it's attractive for us.

That perspective in the sense that it can get us to an approval much earlier, so very similar to what we had historically done we'd be looking basically to piggyback on a successful study design.

John Lawrence Newman: Hi, guys. Thank you for taking my question. I just wondered if you could talk a little bit more about the design of the pivotal study in pancreatic cancer, including the potential endpoints that you could look at there. Hey y'all, it's Matt Coffey.

Yes.

Okay, great. Thank you.

Your next question comes from the line of Patrick <unk> from H C. Wainwright. Your line is now open.

Matthew C. Coffey: What we're looking at is very similar to what we initially had planned with the PanCan people. It's quite an innovative design in the sense that it uses adaptive technology and what we really thought was clever about it. It's an FDA-approved protocol, so they're used to the idea of an interim look and an adaptive study. It allows us to more expediently get to an approval. Obviously, PANC is a tough indication, so it lets us have an interim look as well to make sure that we're on the right track. Very similar to... What you'd expect from the Pan-Can, looking at that, the primary end point would be overall survival, which is most meaningful in this patient population, and, obviously, in this patient population, it's an endpoint that we don't have to wait a very long time to get So, very similar to what we have historically done, we'd be looking basically to piggyback on a successful study design. Okay, great. Thank you. Your next question comes from the line of Patrick Trucchio from HC Wainwright. Your line is now open. Hi, everyone. This is Luis Santos in for Patrick.

Hi, everyone. This is Lee census in for Patrick.

Just wanted to.

Just give us a little bit more.

<unk>.

Expansion of the annual cohorts and I think plans number of patients was about 20.

Perhaps that was going to pieces of sufficiency.

Match, the efficacy signals observed to date.

And and what is the timing.

The timing quarter, four or that enrollment thank you.

Yes, sure Tom heightened, but again, so pretty anal carcinoma cohort.

Expansion will actually be 18, additional evaluable patients for a total of 28.

<unk> patients.

So 18 on top of the 10 in stage one of this study and we of course have worked with our statistician too.

Determine appropriate success criteria.

<unk>.

Established short too.

Patrick Ralph Trucchio: Just wanted to discuss a little bit more the expansion of the annual cohort. And if I think the planned number of patients was about 20, perhaps that was going to be sufficient to match the efficacy signal observed to date. And and what is the timing, approximate timing for that enrollment? Thank you. Yeah, sure, Tom Heineman again.

Confirm a signal in that population so what we're looking for in that population would be.

For a successful study would be seven or more.

Responses out of the 28 evaluable patients.

And that would provide I think a great deal of confidence that the treatment.

Thomas C. Heineman: So, for the anal carcinoma cohort, the expansion will actually be 18 additional valuable patients for a total of 28 valuable patients, you know, so 18 on top of the 10 in stage one of the study. And we, of course, have worked with our statistician to determine appropriate success criteria to establish or confirm a signal in that population. So what we're looking for in that population would be, for a successful study, seven or more responses out of the 28 invaluable patients, okay? And that would provide, I think, a great deal of confidence that the treatment we're evaluating is active at a level higher than what is seen with the standard of care checkpoint inhibitor alone, and then once we confirm that signal, then we can discuss next steps and how to move forward as rapidly as possible in that Did that answer your question, or was there another, did you have an additional question? Okay, thank you. I was going to ask a little bit about the timing for enrollment in that. Oh, the timing.

Evaluating is active at a level higher than what is seen with the standard of care checkpoint inhibitor alone.

And then and then once we confirm that signal then we can discuss about next steps and how to move forward as rapidly as possible in that patient population.

Thank you.

Answer to your question.

Or additional additional.

Okay. Thank you.

Okay.

I was going to ask a little bit about the timing for enrollment of that.

Yes, I'm sorry, yes.

The study has been submitted.

This study is a new cohort in the ongoing <unk> study, which is being conducted in Germany.

With the with the Io study group, which is a group of very well.

Well respected an expert.

Kols.

In Germany, but because it is in Germany. The protocol has been submitted to the German regulatory authorities.

Thomas C. Heineman: Yeah, I'm sorry. Yes, the study has been submitted. This study is a new cohort in the ongoing Goblet study, which is being conducted in Germany, with the AIO study group, which is a group of very well-respected and expert KOLs, you know, PIs in Germany. But because it is in Germany, the protocol has been submitted to the German regulatory authorities for their approval.

Their approval, we're not expecting any issues with that and so we're hoping that enrollment will be able to start into that arm of the study.

Probably sometime in may but.

It will be kind of a little bit on.

The regulatory.

Timelines of the German authorities.

Great. Thank you.

Okay.

Your next question comes from the lineup to Louise Chen from Cantor. Your line is now open.

Thomas C. Heineman: We're not expecting any issues with that, and so we're hoping that enrollment will be able to start on that arm of the study probably sometime in May, but it will depend a little bit on the regulatory timelines of the German authorities. Great, thank you. Your next question comes from the line of Louise Chen from Canter.

Hi, Good afternoon, everyone. This is karri <unk> from Cantor. Thank in particular questions on your OS data guidance bracelet. One study this year given the data considered so far can you help us with great expectations here.

Louise Alesandra Chen: Your line is now open. Hi, good afternoon, everyone. This is Kari-Anthony from Canada.

We might change that paradigm.

Unnamed Speaker: Thank you for taking our questions. On your OS data guidance for bracelet one study this year, given the data presented so far, can you help us frame expectations here and how it might change the treatment paradigm? And our second question is on OPEX; given your clinical activities, can you talk about the push and pull on OPEX for 2024? Thank you. Kirby, we missed the second part of your question about OPEX. Yes, we'd just like to know the push and pulls on OPEX for 2024 given your ongoing studies. So, for whatever reason, we have a terrible connection.

Second question is given.

Given your clinical activities can you talk about the pushes and pulls on opex towards 2024. Thank you.

That's correct.

Currently we missed the second part of your question about Opex.

Yes.

Just like to know the pushes and pulls on Opex for 2020, given your studies.

For whatever reason, we have a terrible connection it's breaking up I'm sorry.

Oh.

Yes, maybe okay.

This is better or the same yes.

Unnamed Speaker: Yeah, it's breaking up. Sorry. Oh, yeah, maybe we could. Okay. Is this better or still the same?

Okay.

I'd like to know which imposed on Opex for 2024.

Unnamed Speaker: Yeah. Okay, I'd like to know the push and pulls on OPEX for 2024. Any color there?

Any color there.

Alright.

Unnamed Speaker: So, for Tom Heineman here, I cannot address the second part, but I can address the first part about the overall survival results. The, in the Bracework Study per protocol. The study will start two years after the last patient was enrolled. So that will be late in the second quarter.

So Tom Hydro.

Cannot address the second part, but I can address the first part about the overall survival results.

In the brief look study per protocol.

The study will.

And.

Two years after.

The last patient was enrolled so that will be.

Late in the.

Second quarter.

Thomas C. Heineman: And when that happens, then we will be in a position to do the final database cleaning and the final calculations around overall survival. So we expect to have overall survival results probably in the third quarter, internally in the third quarter, but this will be reported later in the year. Does that answer your question related to overall survival? And given your hazard ratio that was provided earlier, I think it was last year, what are the expectations here, given the population? Given the population, how many months are we thinking of? Any information on how it might change the treatment paradigm would be helpful.

And when that when that occurs then we will be in a position to do the final database cleaning in the final calculations around the overall survival. So we expect to have overall survival results.

Probably in the third quarter internally in the third quarter, but this will be reported later in the year.

Does that answer your question related to the overall survival.

And given your.

The ratio.

Good luck.

There was last year.

Wanted to expectations here given the population how many months are rethinking.

Any.

<unk> changed the treatment paradigm.

Any information would be helpful. Thank you.

Thomas C. Heineman: Thank you. Well, as we reported last year, The Progression-Free Survival showed a 50 to 100 percent benefit compared to the control arm in the bracelet study, okay? And so I don't want to speculate on the overall survival results until we have all the data and have an opportunity to review it appropriately per protocol, but we are optimistic that the overall survival will ultimately be in line with the, and when I say be in line, I don't mean necessarily month for month, but that the overall survival will ultimately validate the PFS benefit that we saw and reported nine months ago or so. It's awesome. That's great!

Well as you would as we reported last year.

Progression free survival.

Showed a.

50% to 100% benefit.

Paired to the control arm in the bracelet study okay.

And so.

We I don't want to speculate on the <unk>.

Overall survival results until the until we have all the data and have an opportunity to.

Okay.

Review it.

Appropriately.

Protocol.

But we are optimistic that the overall survival.

We will ultimately be in line with the <unk>.

Right.

So it'd be in line I don't mean necessarily month per month, but that the overall survival will ultimately validate the PFS benefit that we saw and reported nine months ago or so.

Awesome that's great.

Unnamed Speaker: I don't know if the rest of the management team was able to hear my second question, but if not, that's all right, too. Thank you. Yeah, Noah, just what were you wanting to know about our operating costs? Yes, so, you guys have ongoing studies in 2024, but also initiating, coming up with, and initiating new studies. So I just want to know how we should think about OPEX for this year. Okay, so for 2024, just compared to 2023, we do see those coming off in terms of our operating costs more in line with, I guess, 2022's, sorry, 2021's level on OPEX. In terms of the R&D and clinical related costs, it will just be a function of how quickly we can move forward with our clinical plan and move the pancreatic cancer program forward and into the clinic, and then what we hear from the FDA on the breast cancer study.

Yes.

The management team.

Are you able to hear and then my second question, but.

But.

Alright. Thank.

Thank you.

Correct.

Just.

What were you wanting to know about.

Operating costs.

Yes. So you guys have ongoing studies and so that's the report but also initiating.

Coming up with initiating new study. So I just wanted to know how we should think about opex for this year.

Okay.

So for 2024, just compared to 'twenty three we we do see those coming off.

In terms of our operating costs.

Q4 2023 Oncolytics Biotech Inc Earnings Call

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