Q2 2023 Oncolytics Biotech Inc Earnings Call

Speaker 1: Good morning and welcome to Oncoletics Biotex, 2nd quarter, 2023 conference call.

Speaker 1: 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. And I would like to turn the call over to John Patton, Director of Investor Relations and Communications. Please go ahead.

Speaker 2: Thank you, operator, and good morning, everyone. Earlier this morning, Onklics issued a press release providing recent operational highlights and financial results for the second quarter of 2023. Our replay of today's call will be available on the event and presentation section of the Onklics website approximately two hours after its completion.

Speaker 2: After remarks from company management, we will open the call for Q&A.

Speaker 2: 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 focus, strategy and objectives, the company's belief as to the potential and motive action of Pella re-REP as a cancer therapeutic.

Speaker 2: The company's plans regarding precision promise and the anticipated timing of entering into a definitive agreement in connection therewith. The company's plans and expectations regarding potential registration studies. The company's business development plans and strategies. And other statements related to anticipated developments in the company's business.

Speaker 2: 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.

And in a before-looking statement, in which unclex is present an expectation or belief as to future results such expectations or beliefs are professing good faith and are believed to have a reasonable basis, but there can be no assurance that these statement or expectation or belief will be achieved.

These factors include results of current or pending clinical trials with his sodium with intellectual property protection, financial projections, action-spite regulatory agencies, and those other factors detailed in the couple's findings with Cedar and the SEC. On ClioX does not undertake any obligation to update these four looking statements except as required by applicable laws.

On our call today, we'll hear from Uncle Luke's chief executive officer, Dr. Matt Coffee, chief medical officer, Dr. Thomas Heinemann, global head of business development, Andrew D. Goudadaro, and chief financial officer Kirk Luke. I'll know how to the call off the mat to give a few highlights from this past call. Matt.

Thank you, John , and welcome to all who have joined us this morning.

We are excited by the continued progress of our CARP programs for Pella re-arep, or Pella as we'll refer to it, in pancreatic and breast cancer that are accelerating towards the registrational studies.

In June , at the ASCO Annual Meeting, we presented results from our HR positive her too negative, medisthenic breast cancer program.

Data from the randomized BRACELIT-1 trial showed a 50% improvement in progression-free survival and a nearly threefold increase in confirmed overall response rate for Pella in combination with Paclitaxel vs Paclitaxel alone.

This impressive data readout validated earlier phase two results from IND213, which showed a statistically significant near doubling immediate overall survival in HR positive HER2 negative metastatic breast cancer patients.

Meaning this program is now phase three ready. The company will now prioritize progressing swiftly to a registrational trial of Pella Paclitaxel combination therapy in HR positive HER2 negative metastatic breast cancer.

Our second registration program in pancreatic cancer has generated compelling data and is clearly attracting attention among thought leaders in the community.

This is evidenced by Pella being selected as a new investigational treatment in precision promise, an innovative, adaptive Phase III clinical trial designed to accelerate registration.

pathways for pancreatic cancer therapies and expected to reduce phase 3 costs by about 50% compared to a traditional trial.

The study, if successful, is expected to support approval of Pella in combination with the checkpoint inhibitor and the chemotherapeutic agents, Jimcitabine and Navpactitaxel, for the treatment of first-line metastatic pancreatic ductal adenocarcinoma.

Pelosinclusion and precision promise is supported by prior pancreatic cancer clinical data that suggests it synergizes with checkpoint inhibition and chemotherapy.

As a reminder, our Phase 1-2 goblet study data has almost tripled the average historical objective response rate by combining Pella with NAPAC-LITAC cell, Jimcytabine, and Atizolizumab in first-line advanced pancreatic cancer.

However, in total, we have data from over 120 pancreatic cancer patients we have treated across multiple studies with and without chemotherapy and checkpoint inhibitors, which Tom will discuss a bit later.

Our plan for this indication is to finalize agreements with the precision promise team by the fourth quarter of this year, and we expect to open the investigational treatment appella, a checkpoint inhibitor, Jim Cytabine and Nat Papka Tax Hall in early 2024. At the end of July , we announced the US 15 million equity offering which closed last week.

our programs both represent meaningful registration opportunities and this additional funding further strengthens our position to advance Pella into registrational trials.

We plan to provide guidance on the registration enabling pathway for both of these programs later this year.

Now I will turn the call over to Tom and Andrew for a more detailed discussion of our clinical programs and business development efforts. We will start with you, Tom.

Thanks, Matt. I'll begin my section by summarizing and highlighting the key data from our two pillar programs.

As Matt mentioned, we are thrilled with the readout from a randomized bracelet one trial of Pella combined with Paclitaxel in HR positive HER2 negative metastatic breast cancer. These data show that Pella combination therapy led to a robust improvement in progression free survival. Thank you.

with a hazard ratio of 0.29 and a nearly threefold increase in the confirmed overall response rate. Just to emphasize, a hazard ratio of 0.29 means a combination of Pella and Paclitaxel reduced the risk of disease progression by 71%.

compared to paclitaxel monotherapy. We hosted a key opinion leader webinar on June 5th to provide expert perspectives on these results and what they mean for our HR positive, HER2-negative breast cancer program's next steps. If you missed the webinar and are interested in a more detailed discussion of the bracelet one results, please contact the HR positive, HER2-negative breast cancer program's next steps. If you missed the webinar and are interested in a more detailed

We encourage you to watch the replay that is available in the events and presentations section of our company website. As a reminder, Bracelet-1 is a randomized phase 2 trial that enrolled a total of 48 HR-positive, HER2-negative metastatic breast cancer patients into three groups.

The control group that received Pactletaxyl monotherapy, a group that received the combination of Pactletaxyl and Pellah, and a third group that received Pactletaxyl Pellah and the checkpoint inhibitor of Valiumab.

The bracelet 1 primary endpoint was overall response rate of week 16 with additional endpoints of progression-free survival, safety and tolerability, and immune biomarker evaluation.

The bracelet 1 primary endpoint of overall response rate of week 16 increased from 20% in the paclitaxel monotherapy arm to 31% in the paclitaxel pellet combination arm.

The benefit of adding Pella to Paclitaxel became even more apparent as the data matured with a 37.5% confirmed overall response rate in the Pella-Paclitaxel combination arm compared to only 13% for Paclitaxel monotherapy.

Adding a Valium-Apto-pactlotaxone pellet did not improve anti-cancer activity, which reinforces our decision to focus on the pellet-pactlotaxone doublet as we move forward to our registrational study.

Bracelet-1 also includes an endpoint of progression-free survival which has been used to support approvals on oncology drugs including in breast cancer.

We observed a robust increase in progression-free survival in the Pella plus Paclitaxel cohort compared to the control arm.

Median progression free survival was 6.3 months in the paclitaxel monotherapy group and increased by more than 50% to 9.5 months in the Pella-paclitaxel combination group for a hazard ratio of 0.29 as of a March 2023 data cutoff.

While the study was not designed for statistical comparisons,

The progression-free survival benefit in the Pella plus tachytax alarm did, in fact, reach statistical significance.

The addition of avelumab to the Pella-pactlatexil combination did not add clinical benefit. In fact, the avelumab combination behaves similarly to paclitaxel monotherapy suggesting that the addition of avelumab actually nullified the beneficial effects of Pella.

The question of why adding a Valumab may have reversed the beneficial effects of the Pelopaclitaxel combination therapy was discussed during our key opinion leader webinar on June 5th. Briefly, a Valumab is unique among licensed checkpoint inhibitors in its ability to bind FC receptors, including those on immune cells.

This may have led to the eradication of potentially protective Pella-induced immune responses. Translational data from the BRACEL 1 study support this hypothesis.

It is important to note that overall survival results from bracelet one have not been reported yet as multiple patients continue to be followed for survival.

Bracelet-1 is the second randomized phase 2 study in which Pella combined with Paclitaxel provided clinical benefit in patients with metastatic breast cancer.

Specifically, these data support the findings from the earlier IND213 study in which Pella plus Paclitaxel demonstrated a statistically significant near doubling of median overall survival in HR positive HER2 negative metastatic breast cancer patients.

These two trials, taken together, provide a strong foundation for a registrational study with dual primary endpoints of overall survival and progression-free survival.

Incorporating progression-free survivalist endpoint offers the potential to deliver a key data readout substantially earlier than would be possible with a single primary endpoint of overall survival.

Based on the findings from IND213 and BRACE01, we can now confidently move to a registrational study in HR positive HER2-negative metastatic breast cancer. Next I'd like to switch to a discussion of our pancreatic cancer program.

Our phase 1-2 goblet trial in which patients are treated with Pella plus Roche's checkpoint inhibitor atezolizumab is evaluating multiple gastrointestinal cancers and continues to make encouraging progress towards key milestones especially in the pancreatic cancer cohort which forms our pipeline's second core pillar.

As Matt mentioned, we are very excited that pelicombinational therapy has been selected by a panel of pancreatic cancer experts as a new investigational treatment arm in the PIVITAL PRECISION PROMISE PHASE 3 PLATFORM TRIAL.

The precision promise trial is designed to accelerate the development of promising new therapies for metastatic pancreatic cancer. The trial was designed with guidance from the FDA and optimizes the number of participants needed to generate licensure enabling data.

This, along with operational efficiencies, can accelerate late-stage development by up to two years compared to traditional, registrational trials. The inclusion of Pella-based combination therapy in the Precision PROMIS trial is based on data from our prior pancreatic cancer clinical studies that support Pella's ability to synergize with checkpoint inhibition and chemotherapy.

to benefit patients with metastatic pancreatic cancer. Prior data include preliminary results from our phase 1, 2 goblet study that showed a 69% objective response rate in first line advanced or metastatic pancreatic cancer patients treated with Pella, combined with atezolizumab and standard of care chemotherapy, gemcitabine and NAPAC-clotaxel. This compares to an average of about 25% objective response rate observed in historical trials in metastatic pancreatic cancer. While the goblet study is our most recent pancreatic cancer trial, we also have data from several prior studies in this disease. These studies laid the foundation for the goblet study.

as they suggested that Pella-based combination therapies could provide favorable outcomes in pancreatic cancer patients. These included improved overall survival as well as potentially beneficial immunologic effects including the stimulation of adaptive immune responses.

and an influx of CD8 positive T cells into the tumors. Looking forward, we anticipate providing updated data from the goblet pancreatic cancer cohort, as well as updates from the advanced anal and metastatic colorectal cancer cohorts in the second half of the year.

We will also provide additional guidance on the path towards registration in pancreatic cancer later this year. Rounding out our recent clinical news, at ASCO this year we also presented additional preclinical analyses pertaining to Pella's ability to improve CAR T cell therapy in solid tumors.

These studies were conducted at the Mayo Clinic in collaboration with Dr. Richard Vile.

and followed a publication in Science Translational Medicine last year that reported Pella's ability to synergistically enhance CAR T-cell efficacy in marine cancer models.

Specifically, Pella has shown the potential to enable CAR-T therapy to effectively treat solid tumors by addressing the most challenging roadblocks for this type of therapy, including reducing antigen escape, improving T cell perseverance, overcoming the challenging solid tumor microenvironment,

notably demonstrating that a Pella boost can enhance efficacy including cures in 80% of murine solid tumor cases.

And with that, Andrew will now speak about our business development efforts. Andrew? Thank you, Tom, and good morning, everyone.

From a BD perspective, the top-line data readout from our BRACELIT 1 trial was the featured headline of the quarter.

As the bracelet one data mature and we integrate data that we've already generated from IND213 and the wear one

we'll be able to better leverage the full suite of immunotherapeutic effects of pellon breast cancer.

As we move towards registration, we plan to pursue the most advantageous Global Clinical and Commercialization Partnership.

We have already established several relationships with leading biopharma companies like Pfizer, Roche,

Merc Serrano and others.

This initial interest came from our previously reported IND-213 study, which demonstrated statistically significant near doubling of median overall survival in HR positive, HER2 negative metastatic breast cancer patients.

The same calculation that was treated in bracelet one.

The effect of these news events are still being felt in the Precision Promise announcement Tom discussed. What some people may not realize is the vetting process for Pelorheirap to be included in the Precision Promise platform trial was quite rigorous. We had meetings and presentations with multiple pancreatic cancer top US key opinion leaders over the course of several months where they reviewed the goblet data, but also multiple historical pancreatic cancer studies that in aggregate have included over 120 Pelorheirap patients. We were very pleased to have been selected for this phase 3 opportunity and we look forward to a productive relationship to bring better treatment options to pancreatic cancer patients.

We also continue to be excited by the preclinical CAR T results presented at ASCO and in science translational medicine. CAR T therapy has generated more than a billion dollars in sales last year in a subset of cancer patients with hematological malignancies.

The potential for PELLETS to enable CAR T therapies and solid tumor indications represents an opportunity for us to expand what is an already large market.

and solid tumors are the vast majority of the cancers diagnosed each year.

Our strategy is to engage potential partners with the goal of outlicensing Pella's development as an enabling technology for CAR T therapies, which would allow us to participate in the lucrative upside potential CAR T commercial opportunity with minimal risk and a continued focus on our current core clinical programs in breast and pancreatic cancer.

The impressive and growing safety database, HOPELA, combined with numerous leading anti-cancer agents without causing unacceptable toxicities, has been exhibited across many combinations and indications.

This supports the case for continued development of Pella as an immunotherapy backbone that can enhance the efficacy of other agents and continues to be a strong selling point in our conversations.

with potential partners who are interested in harnessing its immunologic effects to maximize the commercial impact of their own drugs and therapeutic candidates.

Next, I'll hand it to Kirk to discuss our recent financial results. Kirk? RMIT Press,

Thank you, Andrew.

I'm pleased to report that Onclitics continues to improve its financial position.

As Matt mentioned, at the start of our call, we successfully raised $15 million US through a public offering led by a healthcare-focused institutional investor.

These funds, along with our existing resources, allow us to move forward with the definitive agreements for the Precision Promise Study and obtain the necessary regulatory approval to start enrollment.

With the ASCO Bracelet 1 data in hand, we can continue to move forward with the regulatory process seeking FDA advice and guidance on a registrational study in HR positive HER2 negative metastatic breast cancer.

After the close of our recently announced public offering, our pro forma cash balance stands at $42.7 million and our anticipated financial runway now extends towards the end of 2024. Our general and administrative expenses for the second quarter of 2023 were $3.5 million compared to $2.8 million for the same period last year. Now, the increase is primarily due to higher investor relations activities and a rise in costs associated with our annual general meeting.

Research and development expenses for the second quarter of 2023 were 3.7 million compared to 3.2 million for the same period last year.

Now the net loss for the second quarter of 2023 was $7.4 million compared to $5.1 million in the second quarter of 2022. This equates to a net loss of 12 cents per share for the second quarter of 2023 and 9 cents per share for the second quarter of 2022. This completes my financial review and brings us to Matt's closing remarks. Matt? Thanks, Kirk. Now before moving to the Q&A, I'll provide a brief recap of all the exciting milestones we expect to achieve by the end of the year. We plan to provide updates at ESMO in the second half of the year from goblet patients in our first...

of breast cancer. The Breakthrough 1 overall survival data continues to mature, so we'll provide an update on that timeline once we can provide a reasonable expectation.

As always, I would like to express my gratitude for all the contributions from our collaborators, talented employees, dedicated investigators, the patients participating in our studies, and of course, all of our investors. We'll now open the call up for questions. Operator?

I would like to express my gratitude for all the contributions from our collaborators, talented employees, dedicated investigators, the patients participating in our studies, and of course, all of our investors. We'll now open the call up for questions. Operator? Thank you, sir.

Ladies and gentlemen, if you would like to ask a question, please press star followed by 1 on your touchtone phone. You will then hear a three-tone prompt acknowledging your request. And if you would like to withdraw from the question queue, please press star followed by 2. And if you are using your speakerphone, we do ask that you please lift the handset before pressing any keys.

Please go ahead and press star 1 now if you do have any questions. And your first question will be from Patrick Turrico at HC Wainwright. Please go ahead.

Thanks. Good morning and congrats on all the progress. I guess just a couple of questions for me. The first is, can you talk a little bit about the pace of enrollment in the Precision Promise Program and specifically how much influence will you have on the conduct of this program?

And how is it expected to accelerate the registration pathway for Pella Rio-Reth? And then secondly, also regarding this program, you know, what would you expect to be necessary to lead to an accelerated approval pathway in pancreatic? And when might you have that first data cut from the program?

Thanks, Patrick. That's a great question. Tom and Andrew are probably closest to this, so I'll let Tom talk to the regulatory acceleration and the benefits of working in this. I think Andrew might want to weigh in a little bit on what their presumed timelines are based on.

the enrollment assumptions that they've made public. Tom, do you want to kick us off a little bit? Sure. So the benefits of working with Precision Promise, well there are several benefits in addition to the...

the cost considerations. One of the benefits is that the Precision Promise Protocol is already a well-established study that has been vetted by and discussed at length with the FDA and so we...

have already a very solid, we know that we're entering a study with a very solid

a very solid, we know that we're entering a study with a very solid clinical

program, you know, a very solid clinical pathway. So the

The study is already working with well-established and in fact many of the best.

academic sites in the US so that we have a whole access to a large number of

so that we have a whole access to a large number of

pancreatic cancer experts and they're all very experienced not only in pancreatic cancer but in with this particular study and so there is a very solid

group of partners with whom we'll be working right away which will not only enhance

the enrollment but also provide us with individuals with whom we can work, who can help us make sure that everything is going smoothly with the study and deal with any issues that might arise during the study.

And from a regulatory perspective, as I said, this study was developed and discussed already with the FDA. And so if everything goes smoothly and we come out the other end with the anticipated positive results, then there should be a clear path.

towards a BLA submission directly from the results of this study without having to do additional studies subsequently.

So that's some of the benefits of working with them in addition to the operational benefits which of working with sites, as I said, who are very experienced already. Since this study is up and running, we can save time because we will not have to do things like initiate sites and get everyone familiar with the protocol.

So I think that there are obvious operational efficiencies in addition to the regulatory benefits and the access to the strong experts in the field.

Yep, that's helpful.

As a number of sites and anticipated enrollment, I think we're targeting 18 months after the time of initiation for that first read.

Yeah, about that. We expect we'll sign the agreement.

in the next couple of months, hopefully, somewhere around there and then it's.

about 17 months to get to Go No-Go.

analysis, so figure around the first half of 2025, we'd have that initial read, Patrick, because of the fact that…

And this is much faster than if we had to start this organically, as Tom was saying, where you have to start every site. In terms of number sites, you have to start every site.

They're at 28 sites. What's unique about the sites is they're all brand name, top sites with some of the most famous...

pancreatic KOL in the industry. So you're talking about places like MD Anderson, hormonal tone, catering, and the like.

So you're talking about places like MD Anderson, Memorial Sloan Kettering and the like.

So, you know, they can recruit fast because that's what patients are referred to for something as intractable as pancreatic.

So they've given us their projections. We're pretty positive that we can get to that go-no-go decision around the first half of 2025, assuming everything moves forward as planned with the execution of the definitive agreements.

and other paperwork that needs to be put in place. And that's already ongoing as we speak.

Right. Got it. That's really helpful. And I'm wondering if you can discuss further some of the preclinical research collaboration evaluating Pella plus CAR T combination, and when you might have further details to present.

That's a great question. So we do have companies we've been public about without naming whom who are testing our Pelorheo rep with their carteeds.

because you know we believe that largely for instance with PD-1L1s we work pretty well with all of them with the exception of one that had that FC portion discrepancy.

That's not the case with CAR Ts. These, as you know, are very particular, both to the antigen, their constructs.

how they're made, and what they target. And so we really have to go one by one with companies that are interested and have our Pella tested with their constructs. So far, the results have been promising.

But I don't know yet when those will be presented because a lot of that is really in the hands, is dependent on the type of agreement and how willing the company may be to share those results publicly quickly, especially if it confers a potential advantage in moving forward.

But certainly before anything moves into the clinic, they would have to sign a definitive licensing agreement with us to allow them to do that work. And so at that point, we would make something more public for sure.

Great, thank you very much.

Thank you. Next question will be from Shomit Roy at Jones Research. Please go ahead. If your Indracurricular

Good morning everyone and congratulations on all the progress. On the breast cancer front,

trying to understand how stringent was the enrollment criteria for the HER2 negatives? Do you think there were some HER2 lows were considered prior to re-emergence of HER2 low to be actually effective against HER2 therapies?

How stringent was the enrollment criteria and what went right, in fact, with your 15-16 patient on each arm trial that is giving you the confidence that in the registration trial you want to have that kind of enrollment criteria that would continue the success.

Tom, do you all want to jump in and talk about sort of the evolving HER2 status and what that means potentially going forward and why we're so confident that this study is replicating what we're seeing with IND213?

Sure. So when this study was enrolled, of course the concept of HER2LOW as a...

as a marker for specific therapy was not in play yet, right? The antibody drug conjugates had not been approved.

So patients, so we do, so we are, I'm quite sure that in this study both we enrolled both her two negative and her two low patients as would have been expected in a study like this.

But the reason that we're confident that the data from this study provide a basis for moving forward

is that in this population, these are patients who had failed.

standard of care hormonal therapy including CDK4-6 patients. So this is a population that is very typical of patients who with metastatic breast cancer who are now ready for chemotherapy.

And in this population, we saw a very strong...

objective response rate and PFS benefit. And so going forward, these patients are still going to exist in the real world, even with the advent of the antibody drug conjugates, because some patients, as you know, will not be-

eligible for antibody drug conjugates and they will need options but even perhaps more importantly there are going to be patients who receive antibody drug conjugates who then fail those because as good as they are they are not cures. So once patients are treated with antibody drug conjugates and then and then progress.

they will also need treatment options and we believe that the that the pella base combination will be a very potentially beneficial.

treatment for both patients who are antibody drug-conjugate ineligible and those who ultimately fail antibody drug-conjugate therapy.

So for the registration trial, how would you set up the enrollment criteria? Would you set up the enrollment criteria for the registration trial?

make it strictly as HER2 negative or you would be more amenable depending on the physician's charges if they are ready.

Well, I think, I mean, this is a matter for ongoing discussion, including ultimately with the FDA, but I think we can pretty confidently say that there is a medical population with a substantial medical need that we can define in the phase three population, right? So whether the exact details.

need to be worked out, but it's likely to include, for example, patients who have failed antibody drug conjugate therapy, plus or minus, perhaps, those patients who are ineligible for antibody drug conjugate. So there are plenty of patients out there.

Who are going to need options and I don't think we'll have any trouble defining a population in phase three that can address that need Understandable, thank you for the color and just one last question When should we expect the update on the registration trial for breast cancer? Is it more like end of the year and the second is a third is?

The pancreatic cancer trial, do we know the primary endpoint? Is it the CFS or the OS?

I mean, for the pancreatic cancer trial, it will be an overall survival, right, as is typical customary in pancreatic cancer studies.

Perhaps I'll let Matt comment on the update of the breast cancer.

Yeah, so that we're um

We're letting the OS actually develop just to make sure that we have the likelihood of a dual endpoint. We're still actually tracing or tracking patients who are just receiving Paclitaxel plus Pella. So we haven't even got to the full PFS actually on that, which is fascinating because you know ARM1

you know, we didn't even get anyone out to like 12 months. We know we have patients out at cycle 22, 23 now. What we sort of suspect will happen is we're in discussion with a number of groups, as Tom alluded to. We think it's probably easiest to capture this population in the post ADAC. So people would go from a CDK46 to a first line ADAC.

We're just seeing people get onto first line 8X now. We do anticipate after...

San Antonio, there will be more of these patients. So we're thinking a sufficient pool of patients will be available mid-next year. In terms of regulatory filings, we'll be reaching out to the agency this year. So we're hoping for the ability to provide some regulatory guidance late this year, early next as the OS matures. But some of this, of course, is just scheduling with the FDA.

And of course, the parties we're talking to who have vested interested in the ADACs would obviously like us to not cannibalize those sales, but rather be creative to them by just tracking the same patients that are going to be able to receive the HR lows. And presumably, Shumin, as I'm sure you know, I'd ask how.

The true HR negative patients, you know, there's literature now saying you can test a patient, have them be negative, test them again, and they'll be slightly positive. So the whole concept around what is an HR negative patient I think is in flux. So I think, you know, by, you know, doing a regulatory filings this year, we'll have more color around what the true nature of the patient population is. But as Tom said,

there's no shortage of these patients. We're very confident we'll get to a definable patient population that stakeholders and the FDA can agree with.

Thank you so much again for all the color and taking the questions. We look forward to the ASMO data.

Thanks so much.

Thank you. As a reminder ladies and gentlemen, if you would like to ask a question, please press star followed by 1 on your touchtone phone. And your next question will be from John Newman at Cana Court. Please go ahead.

Hi, guys. Good morning, and thanks for taking my question. So, Matt, just kind of a follow-up question on the ADCs. How do you think about...

Pelorep, excuse me, being used long term with ABCs. Do you kind of, do you see a pathway here where perhaps you get your initial approval in combination with chemotherapy, but then you're able to, you know, you're able to, you know,

perhaps investigate a combination with ADCs, and if so, is there a specific subset of patients that you think might be more attractive for that combination? Thanks. Yeah, no, absolutely. So, the first part of your question, what we would look to do is go after ADAC failures, we're still taxing naive. So,

similar to the patient's population that we treated on bracelets in terms that they would be taxing naive. We don't think that ADACs are especially immunosuppressive. They're actually deemed to be quite...

I don't want to say mild, but mild in terms in comparison to chemotherapy. So we don't think this would be something that would diminish the immunological response.

In terms of ultimately combining with ADEX, we are very interested in that possibility. What we know of our agent is anything that causes a cellular stress does lead to susceptibility, especially in the context of not being immunosuppressive. That it's always been a concern of the company that would be using too high chemotherapy, that you would blunt the immunological...

basically just saying it works better in patients who aren't as heavily pretreated. So we do think that there is a role for combining this with ADEX. That would be part of our lifecycle management and it is something that stakeholders have actively asked us to pursue. So it is obviously an area of interest for us.

Great, thank you. Thank you. And at this time, gentlemen, it appears that we have no other questions. Please proceed with any closing remarks.

Well, thank you, operator, and thanks to all who joined our call today. Have a great day. Thanks very much.

Thank you, sir. Ladies and gentlemen, this does indeed conclude your conference call for today. Once again, thank you for attending. At this time, we do ask that you please disconnect your lines.