Oncolytics Biotech Inc (ONCY) 2023 Q4 法說會逐字稿

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.

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.

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 Ontex website approximately two hours after its completion.

After remarks from company management, we will open the call for Q&A.

As a reminder, various remarks made during this call contain certain forward-looking statements relating to the Company's business prospects and the development and commercialization of pelareorep, including statements regarding the Company's mission strategy and objectives, the Company's belief as of the potential mechanism of action and benefits of pelareorep as a cancer therapeutic.

Our clinical development plans for 2024, including initiation of our first registrational studies for pelareorep manufacturing program, our cash runway and other statements related to anticipated developments in the Company's business.

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

Any forward looking statement and 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.

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

I'm going to undertake any obligation to update these forward-looking statements, except as required by applicable laws, complex 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 Oncolytics Biotech Fourth Quarter Conference Call 2024 months of the year that Outotec will become a late-stage cancer company with the initiation of our first registrational studies for our proprietary immunotherapy immunotherapeutic product candidates, pelareorep or pillar, as we'll refer to it, brings us closer to achieving our mission of improving the lives of patients with cancer.

So we'll begin the year with significant enthusiasm.

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 for Oncolytics is set up for success at Calamos 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 our 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 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 has achieved the predefined, quote unquote Stage one because criteria defined according to the Simon two stage study design.

In addition, data from the patriotic and anal cancer cohorts demonstrated response rates that were nearly three times greater than published historical control.

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 Peleus mechanism of action as an immunotherapeutic agents.

Importantly, the data demonstrated a positive correlation between response rates and Paladin's ability to induce the expansion of T-cell population measured by increases in the cell TIL score and the level of tumor infiltrating lymphocytes or TILs in the peripheral blood cell expansion could become an important biomarker of clinical outcome that could be used in future clinical studies and to guide patient care 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 from BRACELET-1 continued to mature for patients receiving pela and paclitaxel.

Overall survival is an important metric to potential partners and 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've sharpened our strategic thinking thanks to the contributions of our Board of Directors, including our new director, Pat Andrews, for experience 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 than with pela forward on the regulatory pathway.

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

Also in 2024, we plan to initiate a registration study propeller in 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 pela in combination with paclitaxel compared to paclitaxel monotherapy in patients with metastatic disease who are HR-positive HER2-negative.

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.

So that being said, the data we've reported so far are supportive of the statistically significant near doubling of median overall survival seen in the INE313 study.

With respect to our plans for pancreatic cancer, we expect our registration study to focus on the evaluation of pela in combination with pidilizumab, gemcitabine and nab-paclitaxel compared to the combination of gemcitabine and nab-paclitaxel in patients receiving first-line treatment for pancreatic ductal adenocarcinoma or PDAC.

We continue to develop a study protocol that utilizes an adaptive design build on the positive results from the GOBLET study.

The registrational strategy for pediatric will incorporate learnings from our previous interactions with the Pancreatic Cancer Action Network, also known as PanCAN and ongoing conversations with our newly announced alliance partner to 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 propelled potential in this indication reinforces our commitment to bringing new treatment options to patients.

I'd also like to mention the expansion the enrollment in the Golden cohort focused on anal cancer, the American Cancer Society estimates that there will be about 10,500 new cases of breast 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.

The study will evaluate the combination of pela and atezolizumab in patients with second line or later disease.

While in 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 Heinemann, 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 telling employees to embark on registrational trials for pancreatic cancer and breast cancer as early as 2024 to consistently positive outcomes from seminal studies such as BRACELET-1, AWARE-1 GOBLET, so captured the attention and deepened engagement at the clinical oncology community and potential strategic partners.

Secondly, we eagerly anticipate the forthcoming release of overall survival data from BRACELET-1 breast cancer study in 2024.

This data represents an important milestone anticipated to serve as a significant catalyst in bolstering our registration endeavors for power and a focal point of interest for our prospective biopharma collaborators.

Lastly, the compelling data stemming from the anal carcinoma cohort or the GOBLET study advocate for the expansion of this cohort with the potential for fewer than 20 additional patients to be enrolled, we can swiftly transition towards a registrational study in this critical unmet need area.

Particularly noteworthy is the distinctive approach of excluding chemotherapy in favor in favor of leveraging the demonstrated synergy between pela 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 Ark-La-Tex organization and our collaborators for your dedication to the mission to improve the care of patients with cancer work to adapt the development appellate inspires me and everyone around us every day.

Tom?

Thanks, Matt.

During today's call, I'd like to provide a snapshot of the key features of pillar in an update on our ongoing clinical programs.

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

Some tumor cells are killed directly by TEL infection.

In other cases, Pell infection results in the accumulation of double-stranded RNA in the cancer cells.

This induces a pro-inflammatory response in the tumor microenvironment that times the tumor for immunologic killing specifically pela infection results in increased T cell infiltration into the tumor expansion of tumor infiltrating lymphocytes, also known as tails and stimulation of both innate and adaptive immune responses we can assess the immunotherapeutic action of pela 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 pellet treatment by such measures as the expansion of T cells in the blood 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, Oncolytics provided important clinical and translational data from the BRACELET-1 study for multiple GOBLET study cohort and from the AWARE-1 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 Pelon breast cancer, initiate a registrational study of pela in pancreatic cancer and report the overall survival results from the brace of one breast cancer study.

In addition, we plan to initiate a new pancreatic cancer cohort and the GOBLET study.

The new cohort will evaluate pela plus modified full-field dox with or without atezolizumab in patients with newly diagnosed metastatic pancreatic cancer.

This new cohort will be supported by the $5 million PanCAN therapeutic itself accelerator granted and has been submitted to the German regulatory authorities.

We also will expand enrollment into the anal carcinoma arm of the GOBLET study.

Now I'd like to add a few additional comments on the brace of one breast cancer data, the new pancreatic cancer cohort in the GOBLET study and the expansion of the GOBLET study, anal carcinoma cohort.

We continue to follow brace of 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, 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 IND 213 breast cancer study.

Furthermore, if they support the possible use of progression-free survival as a 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 pela plus modified for paradox with or without atezolizumab is expected to begin enrollment in the coming months.

We are enthusiastic about this new cohort because it will enable us to study pela 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 has an important voice in the pancreatic cancer community and our work with them has led to valuable relationships with key leaders in this field.

Moreover, their belief in the potential of pela 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 pela 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.

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 pela and atezolizumab 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 additional 18 evaluable patients, and we plan to add more study sites to reduce the enrollment time.

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 pillars 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 pellet in an indication of 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.

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

Next step, as Matt mentioned, at the start of the call, Allison will provide an update on our manufacturing and product development efforts.

Allison?

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 pellets, registrational study readiness.

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

Throughout my discussion, you'll hear me use the word products, 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 in purified bulk pelareorep material, the active pharmaceutical ingredients drug substances used in the manufacture of drug products, the finished dosage form package for patient administration.

Key takeaways from my section are we have a well-established product supply chain for Pella.

We have made numerous batches of material at increasing scale and power 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 how a 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 Celsius.

Material has a long shelf life with ongoing drug substance stability out past 10 years, plus an established drug product expiration period of six years from date of product filling it is made by our contract development and manufacturing organization or CDMO Millipore Sigma assay of fields 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 Millipore Sigma 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 the FDA and other health authorities.

They have handled numerous biologics over the years and are a leader in viral vector manufacturing.

So they are familiar with assets like pela, 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 manufacturing.

In the fourth quarter of 2023, we initiated a new GMP production campaign with the drug substance process transition to single use equipments and scaled up to a 200 liter bioreactor, increasing the purified batch size to about 12 liters of bulk drug substance for first GMP batch has been completed and once routine manufacture has been established, our next step will be the validation batches.

Our successful track record in scale-up and consistent production gives us confidence that our investment in the next level of our drug substance batches will go well as we continue this work in 2024 and 2025.

In conjunction with the scale-up, we also optimized from upstream elements of the process, including a change in detergents to mind with European long-term guidelines.

Thankfully, this switch won't impact the purified drug substance or products for detergents is cleared through the purification steps.

And the final pillar, product concentration and formulation remains the same.

In addition to drug substance manufacturer 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 high level of sterility assurance and also allows for larger quantities per month, reducing the cost of goods.

Moving on to a few operational notes.

Pela is very simple to ship and store at study sites.

We believe the user-friendly product interfaces importance and are confident that tell us that that specification well, our drug product, single dose vials are shipped to steady-state from dry ice and can be stored at minus 80 or in a minus 20 Celsius freezer.

It is straightforward to prepare dose per 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, 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 registration.

We plan to invest in manufacturing over the next year to support our registration plans for pela.

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 last 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.

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.

We believe this will enable us to achieve the most critical near term milestones set out in today's 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, equating to a net loss of $0.05 per share in the fourth quarter of 2023 compared to $0.14 a share.

And for the same period in 2022.

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 $0.41 per share for the '23 period and a net loss of $0.43 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, mainly related to the change in fair value of warrants issued as part of our 2023 public offering.

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.

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

Our 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, 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.

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

So in closing, I'd like to spend a moment to elaborate on a few of Matt's comments regarding our organizational transition pathway as a potential backbone immunotherapy that has shown efficacy signals in multiple indications.

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 pellets potential through initiatives like pan cancer therapeutics accelerator program, which after a thorough and highly competitive process, resulted in the grant of USD5 million fully funding our modified pulse ox, Peder cohort and GOBLET.

There are also opportunities to broaden Pallas application to indications like anal cancer for an efficacy signal has emerged.

We have assembled a management team that is well positioned to bring color to patients and attracting a board member like Pat Andrews reflects the strength of our team and tell us potential.

Finally, we have fostered important relationships with organizations like PanCAN pre COG, AAO and clinical collaborators like Pfizer and Roche are 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 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.

Matt?

Thanks for 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.

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 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 pillars 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 pela and a hopeful outlook for patients with an unwavering dedication to our mission.

Together, all of us were pioneering the 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 treatments.

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.

Soumit Roy, Jones Research.

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

Tom, a quick question on the breast cancer trial.

I'm trying to understand if if you expect any change in the basic V6 baseline patient characteristics value breast at trial versus the potential pivotal trial in terms of our two stated our companion treatments, any differences you expect and also on the manufacturing front, as you have fairly clearly explained, there is a good from 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.

Yes, sure.

Tom Heinemann here.

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 approval recently 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 their next stage of their treatment.

And maybe I'll let Allison Hagemann speak to the next part of your question.

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 in the drug substance or the products.

The raw material input remain the same including the master and working virus.

And all products batches are tested, including identity testing and potency, purity and virus concentration to assure comparability and ability for clinical use.

John Newman, Canaccord.

I guess thank you for taking my question.

I'm just wondering if you could talk a little bit more about the design of the pivotal study in pancreatic cancer, including the potential endpoints, but you could look at the aspects?

Hey, Dan, it's Mike.

Based on what we're looking at is very similar to what we initially had planned with the PanCAN people.

And it's quite an innovative design in the sense that it uses adaptive.

And what we really thought was clever about it is it's an FDA-approved protocol so that they're used to the idea of an interim look in an adaptive study on it allows us to more expediently get to approval, obviously, a tough indication.

So let us have an interim look as well to make sure that we're on the right track of very similar to what you'd expect from the bank.

I'm looking at that the primary endpoint would be overall survival, which is most meaningful in this patient population.

And it's obviously in this patient population.

It's an endpoint that we don't have to wait a very long time to get to is what's attractive from that perspective in the sense that it can get us to approval on much earlier.

So very similar to what we had historically done.

We'd be looking basically to piggyback on the successful study design.

Patrick Trucchio, H.C. Wainwright.

Hi, everyone.

This is Luis Santos in for Patrick.

I'm just wanted to discuss a little bit more the expansion of the annual cohort.

And this, I think plans number of patients was about 20, perhaps that was going to be sufficient to match the efficacy signal observed to date?

And what is the timing approximate timing quarter for that enrollment?

Yes, sure.

Tom Heinemann again.

So for the anal carcinoma cohort, the expansion will actually be 18 additional evaluable patients for a total of 28 evaluable patients on placebo.

So 18 on top of the 10 in stage one of this study, and we of course, have worked with our statistician to determine appropriate success criteria to establish or to 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.

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 about next steps and how to move forward as rapidly as possible in that patient population.

Does that answer your question or additional of the additional question?

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

So the timing?

Yes, I'm sorry.

Yes, the and the study has been submitted.

This is the study as far as a new cohort in the ongoing GOBLET study, which is being conducted in Germany with a with the AIO. study group, which is a group of very well respected and expert KOLs, you know, PI.s in Germany, but because it is in Germany, the protocol has been submitted to the German regulatory authorities for their approval.

We're not expecting any issues with adeno.

And so we're hoping that enrollment will you will be able to start into that arm of the study probably sometime in May, but it will depend a little bit on the regulatory arm timelines of the German authorities.

Louise Chen, Cantor.

This is Cary on for Lousie from Cantor.

On your always stated guidance of BRACELET one study this year and given the data presented.

So far.

Can you help us frame expectations here how it might change the treatment paradigm?

Our second question is on OpEx.

Given your clinical activities, can you talk about the pushes and pulls on OpEx towards 2024?

Probably we missed the second part of your question about OpEx.

Yes, I would just like to know that push and pulls on OpEx for 2024 for keeping your studies ongoing?

It's sort of for whatever reason have a terrible connection.

Yeah, it's breaking up, sorry.

Okay.

Is it better or still the same?

Yeah.

Like no push and pulls on OpEx for 2024.

Any color there?

It's Tom Heinemann, you're right, I did not address the second part, but I can address the first part about the overall survival results.

Cgm in the BRACELET study per protocol, the study will and two years after the last patient was enrolled.

So that will be late in the second quarter.

And when that when that occurs, then we will be in a position to do the final database cleaning and the final calculations around the overall survival.

So we expect to have overall survival results in the 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 hazard ratio, I was as I stated earlier, I noticed last year, what are the expectations here given the population were coming months?

And are we thinking of and the outcome might change the treatment paradigm from any information would be helpful.

Thank you.

Well, as you as we reported last year the progression-free survival and showed a 50% to 100% benefit compared to the control arm in the BRACELET study.

Okay.

And so we I don't want to speculate on the overall survival results until then 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 by NBYSIB. in line, I don't mean necessarily month per month, but that the overall survival ultimately validate the PFS benefit that we saw and reported nine months ago or so.

I don't know if the rest of the management team was able to hear my second question but at the footnote, that's all right.

What were you wanted to know about term or operating costs?

Yes, on so you guys have ongoing studies in storage for, but also initiating coming up with initiating new study.

So I just want to know how we should think about OpEx for this year.

Okay.

So for 2024 just compared to '23.

We do see those coming off from in terms of our operating costs more in line with, I guess, 2022s -- sorry, 2021s level on the OpEx in terms of the R&D and clinical related costs will just be a function of how quickly we can move forward with our clinical plan moving up the pancreatic cancer program forward into it into the clinic and then what we hear from the FDA on the breast cancer study.

We have run out of time for additional questions.

I will now hand the call over to Dr. Matt Coffey for closing remarks.

Once again, I would like to thank everyone for making time to hear about our recent program and how we're planning to involve into a late-stage oncology company this year to date and supporting color as a novel immunotherapeutic agents with the ability to improve patient outcome continues to grow, and we're setting the stage to add to that this year.

I look forward to our next update, and I wish everyone a wonderful evening.

Thank you.

Ladies and gentlemen, this concludes today's conference call.

Thank you for your participation.

You may now disconnect.