Oncolytics Biotech Inc (ONCY) 2020 Q2 法說會逐字稿

Good day, everyone, and welcome to the Oncolytics Biotech Second Quarter 2020 Earnings Conference Call.

Today's conference is being recorded.

(Operator Instructions)

At this time, I'd like to turn the conference over to [Tom Khalasi] of LifeSci Advisors.

Please go ahead, sir.

Thank you, operator.

Good afternoon, everyone, and welcome to Oncolytics Biotech's Second Quarter 2020 Conference Call.

Earlier today, Oncolytics issued a press release providing their financial results and corporate updates for the second quarter of 2020.

A replay of today's call will be available on the Investor Relations section of the Oncolytics website approximately 2 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 about the company's future expectations, clients and prospects constitute forward-looking statements for purposes of the safe harbor provisions under the Private Securities Litigation Reform Act of 1995.

Actual results may differ materially from those indicated by these forward-looking statements as a result of various important factors, including those discussed in the Risk Factors section of the company's most recent annual report on Form 20-F, which is on file with the SEC.

In addition, any forward-looking statements represent the company's views only as of today and should not be relied upon as representing their views as of any subsequent date.

Except as required by law, Oncolytics specifically disclaims any obligation to update or revise any forward-looking statements even if the company's views change.

Now I will turn the call over to Dr. Matt Coffey, President and Chief Executive Officer of Oncolytics Biotech.

Matt?

Thanks, [Tom].

And thanks to all listening for joining us on this call today to discuss our second quarter corporate update.

Now in addition to Tom, I'm joined by Andrew de Guttadauro, our Global Head of Business Development; and Kirk Look, our Chief Financial Officer.

As I begin today's call, I'd like to say how incredibly proud I am of all the members of the Oncolytics team.

Their talents and unwavering dedication has allowed us to make truly remarkable progress over the last quarter, particularly in light of the unpredictable and industry-wide challenges posed by the COVID-19 pandemic.

Through the efficient implementation of a robust business continuity plan, Oncolytics is able to achieve 5 clinical milestones, including 3 data readouts in the second quarter.

Completion of these milestones has proved important clinical validation of our unique Oncolytics virus immunotherapy platform, while also advancing our lead breast cancer program towards the initiation of a registrational study.

Looking forward, we are well positioned to continue reporting a steady cadence of value-creating milestones across our diverse clinical pipeline.

Now I'd like to move on and provide some of our highlights from our productive quarter.

We remain focused on the clinical advancement of pelareorep, our intravenously delivered immuno-oncolytic virus, towards a registrational study in HR+

HER2- metastatic breast cancer.

A substantial unmet need exists in this indication has currently approved therapies, are unable to produce a meaningful survival advantage for the over 112,000 patients with the disease in the United States alone.

To address this unmet need, we continue to build on the results of our Phase II study, IND 213, a metastatic breast cancer trial that showed a near doubling of overall survival with pelareorep treatments in HR+

HER2- patients.

Encouraged by this data, we are conducting our AWARE-1 and various clinical studies.

The completion of which will determine the design of our Phase III registrational program.

Together, these ongoing studies aim to achieve 3 objectives to facilitate the initiation of a Phase III trial.

First, we aim to confirm pelareorep's immunotherapeutic mechanism of action to support the promising efficacy data generated by IND 213.

Second is the informality of the clinical utility of our novel blood-based biomarker measuring T cell clonality to predict the patient response to pelareorep.

And finally, they will evaluate pelareorep's ability to enhance the efficacy of checkpoint inhibitors to improve patient outcomes as there is a robust preclinical and clinical data set supporting the synergistic potential of pelareorep checkpoint inhibitor combination therapies.

With these objectives in mind, I'm happy to report that the second quarter featured the achievements of multiple key milestones which continue to drive our sustained progress towards a registrational trial.

The first of these milestones came from our AWARE-1 window of opportunity study in early-stage breast cancer.

This study is being conducted by SOLTI in Spain and represents the first use of our clinical supply agreement with Roche.

Following a recent expansion in a number of AWARE-1 trial sites, we are rapidly enrolling patients in the study, thanks to a doubling number of study centers that coincided to Spain's reopening.

Also, thanks to last week's successful safety committee review, we once again verified pelareorep's outstanding safety profile.

This progress has been further bolstered by positive data generated such as the recently announced compelling data presented at the 2020 ESMO Breast Cancer meeting.

This data was also highlighted in our recent key opinion leader call, or KOL call, featuring Dr. Aleix Prat, Chair of SOLTI and the lead translation investigator of AWARE-1.

During this KOL call, Dr. Prat spoke to how the AWARE-1 data confirmed pelareorep's immunotherapeutic mechanism of action, support the clinical utility of T cell modality as a predictive and prognostic biomarker, and demonstrated pelareorep's potential to synergistically combine the checkpoint inhibitors across multiple breast cancer sub types.

Specifically, the data showed that systemic pelareorep administration was followed by tumor-specific replication, which led to the creation and mobilization of tumor-targeting CD8-positive T cell clones and increased tumor PD-L1 expression.

Notably, the AWARE-1 results also showed that pelareorep treatment leads to an increase in CelTIL, a measure of tumor information and the study's primary endpoint.

Such data is particularly exciting when considering that patients with high CelTIL scores have improved clinical outcomes.

The increase in CelTIL also correlated with peripheral T cell clonality, supporting its use as a biomarker, which may allow us to select and stratify patients who are more likely to respond to treatment in our pivotal studies.

Taken together previously reported results from AWARE-1, we did demonstrate the substantial progress made towards achieving the critical objectives necessary to move our lead breast cancer program into a registrational study.

Looking ahead, we expect the advancement of this trial to continue in earnest.

We are highly encouraged by this progress, and we'll keep you up to date as the trial advances.

Moving on now to BRACELET-1, our Phase II trial evaluating the safety and efficacy of pelareorep-based combination therapies in HR+/HER2- metastatic breast cancer patients.

Like in AWARE-1, the exceptional work of the oncolytic team and its partners throughout the midst of this pandemic has allowed us to achieve a critical milestone in the study as we recently dosed our first patient following the opening of the first 2 sites in the study.

We expect to see an acceleration in the opening of additional sites over the next quarter as hospitals adapt to the running studies in the COVID-19 pandemic environment.

As a reminder, BRACELET's design was developed in collaboration with Pfizer and Merck KGaA and is essentially identical for the study design of a prior IND 213 study HER2 exceptions.

Firstly, the study focuses exclusively on HR+/HER2- subtypes of metastatic breast cancer patients, which is the patient population in which we saw the pronounced overall survival benefit in IND 213.

Second, BRACELET adds an additional study arm to evaluate pelareorep in combination with Pfizer and Merck's anti-PD-L1 checkpoint inhibitor, Bavencio.

As mentioned earlier, this design was developed to support the overall survival advantage observed in IND 213 by demonstrating pelareorep's ability to induce a robust antitumor immune response in an identical patient population.

Additionally, the study aims to validate T cell clonality utility as a clinical biomarker and evaluate the efficacy of pelareorep checkpoint inhibitor combination therapy.

Importantly, we believe that our AWARE-1 and BRACELET studies present multiple opportunities for value inflection points in the near future, particularly given how prior data and regulatory interactions have derisked our overall breast cancer program.

As those who have been following us for some time may know, we have previously received favorable feedback from the FDA end of Phase II meeting, a favorable EMA final advice letter fast track designation and a special protocol agreement for our metastatic breast cancer program.

These regulatory achievements, combined with our progress in BRACELET-1 and comparing to AWARE-1 data showing that we are on track to meet the clinical objectives we need to initiate a registrational study, demonstrate how the hard work of our employees, partners, patients and investigators have derisked our lead clinical program and set up Oncolytics for near- and long-term success.

Now I'd like to shift gears a bit and talk briefly about the recently announced expansion of our breast cancer program into new disease subtype, triple-negative breast cancer.

About a month ago, we announced our new IRENE study, which is a Phase II investigator-sponsored clinical trial designed to evaluate pelareorep in combination with Incyte's anti-PD-1 checkpoint inhibitor, retifanlimab.

This trial aims to address a critical unmet medical need as there are over 460,000 triple-negative breast cancer patients in the U.S. alone.

Importantly, while checkpoint inhibitor therapy is approved for the treatment of triple-negative breast cancer, it has significant limitations.

Only about half of triple-negative breast cancer patients have the 1% PD-L1 expression level needed to become eligible for checkpoint therapy at this time.

Of those, 40% are likely to respond to treatment.

This represents a very interesting clinical and market opportunity for pelareorep, which is highlighted by the AWARE-1 data showing an ability to increase in tumor PD-L1 expression with pelareorep treatment across multiple breast cancer subtypes.

This data highlights pelareorep's potential to increase the number of patients that are eligible for and can respond to checkpoint inhibitors, whereby helping to address this pressing unmet need in triple-negative breast cancer.

Moving on, I'd now like to shift the discussion away from our primary focus in metastatic breast cancer and towards the progress made in hematological and gastrointestinal cancer indications.

These programs demonstrate both depth of our pipeline and the broad commercial opportunity offered by pelareorep's continued advancement.

Milestone we achieved in each of these programs in the second quarter as new clinical data from trials evaluated pelareorep in multiple myeloma and pancreatic adenocarcinoma were presented as part of the ASCO meeting held in May.

We saw some fascinating proof-of-concept data in multiple myeloma, which is an indication where the incredibly immunosuppressive nature of the cancer microenvironment has prevented the success of checkpoint inhibitors.

When patients in our multiple myeloma trial were treated with pelareorep in combination with the proteasome inhibitor, KYPROLIS, we saw the activation of a profound inflammatory response, accompanied by a 50% overall response rate and 83% clinical benefit rate.

These results include the first reported incidence of cytokine release syndrome associated with clinical response in multiple myeloma.

The induction of cytokine release syndrome, which can be effectively managed with well-established therapies, highlights the ability of pelareorep-KYPROLIS combination treatment to induce robust immune cell activation and tumor lysis in multiple myeloma patients.

The compelling data seen here are even more noteworthy when considering that the trial was carried out in carfilzomib refractory patients who are notoriously difficult to treat.

Importantly, when this recently announced they are considered together with previously reported trial results showing a dramatic increase in PD-L1 expression with pelareorep treatments, we strongly support the success of our ongoing clinical study of evaluating pelareorep, Trastuzumab and an immune checkpoint inhibitor therapy in multiple myeloma.

Finally, before I hand off the call to Andrew to elaborate on our BD efforts, I'd like to give a brief update on our work in GI cancers.

As in breast cancer and multiple myeloma, we have compelling clinical data from our GI malignancies demonstrating pelareorep's potential to synergistically increase the effectiveness of immune checkpoint inhibitors.

This includes data recently presented at ASCO from a trial evaluated pelareorep to treat a combination therapy in second-line pancreatic cancer patients.

These data show that the therapy was well tolerated and resulted in tumor-specific replication, a high degree of T cell repertoire and the creation of new T cell clones in the peripheral blood of these patients.

Looking ahead, these recently reported results add to what is a robust set of clinical data showing pelareorep's ability to prime the immune system across several types of GI cancers.

Notably, this data set is driving some very interesting discussions around potential industry and academic collaboration that may complement our existing relationships quite nicely.

Now to hear some more of these -- more about these excited collaborations and other ongoing BD efforts, I'll hand the call over to Andrew.

Thanks, Matt.

As we mentioned in the past, there's a growing interest from large pharma and biotech companies and improving the efficacy of checkpoint inhibitors by pairing them with oncolytic viruses.

This has been marked by several deals by companies such as Merck, BMS and J&J, which have typically been perceived by initial collaboration designed to evaluate the feasibility of potential combinations.

This is the exact approach Oncolytics is taking with our ongoing pelareorep study designed to evaluate potential synergies of Roche's Tecentriq, Pfizer and Merck KGaA's Bavencio, CMS' OPDIVO and now Incyte's retifanlimab.

The way in which we have been able to gain such central industry collaborations has been by leveraging a robust clinical data set and the exciting market opportunities presented by the clinical areas in study.

One recent example of successful execution of the strategy is with the IRENE study Matt discussed earlier.

As pelareorep's ability to increase tumor PD-L1 levels is precisely withdraw the initiation of this investigator-sponsored (inaudible).

This collaboration, along with our ongoing co-development agreement with Pfizer, Merck KGaA in BRACELET-1 study are just 2 examples of how we're effectively leveraging our compelling clinical data to initiate and foster relationships with large pharma and biotech.

Also important to note that the commercial opportunity of using pelareorep to improve checkpoint inhibitors expands beyond just breast cancer.

As a whole, the checkpoint inhibitor market is expected to reach $25 billion by 2022, even though less than 1 in 5 patients responds to these therapy.

To further accelerate and expand growth, checkpoint companies must look for safe and efficacious ways to further expand their potential indications.

Pelareorep is an extensive synergy data and ability to be administered intravenously represents an exciting opportunity to do so.

As Matt discussed earlier, we have a robust clinical data set demonstrating pelareorep's potential to increase the percentage of patients responding to checkpoint inhibitors.

Not surprisingly, we find that these data consistently drive exciting business development and opportunities across our pipeline.

For example, we're currently working with BMS on a promising study about pelareorep-OPDIVO combination therapy in multiple myeloma patients.

Looking forward, our goal is to secure a global clinical and commercialization partnership to both facilitate pelareorep's approval and maximizes commercial opportunity.

We expect work come in clinical data, particularly in BRACELET-1 and AWARE-1, to drive us towards this goal by advancing our ongoing discussions with potential partners across the pharma and biotech industries.

With that, I'll turn the call over to Kirk Look, our CFO, to discuss our financial results in the quarter.

Kirk?

Thank you, Andrew, and good afternoon, everyone.

I'm pleased to report that Oncolytics remains in a sound financial position as we advance pelareorep towards registration.

Our balance sheet continues to remain strong with cash and cash equivalents of $29.9 million at the end of the second quarter.

This includes net proceeds of $6.4 million from our aftermarket facility, which was recently remade, and importantly extends our financial runway to the end of 2021.

Our research and development expenses for the second quarter of 2020 were $2.5 million compared to $3.4 million for the same period last year.

These activities centered on progressing our AWARE and BRACELET studies, supporting our other checkpoint inhibitor combination trials and securing our clinical supply with the start of CGMP production room.

Our operating expenses for the second quarter were $3 million compared to $1.8 million in 2019.

During this period, the increase in our operating expenses related primarily to an increase in our Investor Relations and business development activities as well as an increase in our directors and officer insurance premiums.

Finally, our net loss for the second quarter was $6.8 million compared to $5.3 million last year, equating to a loss per share of $0.17 for the quarter versus $0.26 for the quarter in 2019.

With that, I'll hand it back to Matt.

Matt?

Thanks, Kirk.

Before we go into the Q&A, I want to emphasize the (inaudible) in the world of oncolytic viruses, which as Andrew mentioned, is an area of great interest in large pharma.

Almost all other oncolytic viruses in development either have at least 1 and often both these 2 characteristics.

We require special handling procedures due to the BSL-3 classification or they require intratumoral delivery, and therefore, cannot reach metastatic disease.

Notably, pelareorep is administered systemically by nursing staff, requires no special handling procedures, has been clinically demonstrated to selectively replicate in local and metastatic tumors.

These characteristics offer Oncolytics substantial competitive advantages over other oncolytic viral companies.

Further, pelareorep has been the only viral agent to show a survival benefit in late-stage metastatic breast cancer and is supported by data from multiple clinical studies demonstrating potential to augment checkpoint inhibitor therapy.

Looking ahead, we expect to build value through the sustained progression of our clinical programs and the continued development of our industry partnerships.

We believe we are well on our way to advancing our lead HR+/HER2 immune metastatic breast cancer program into a registrational study.

And we continue to work diligently with our academic and industry collaborators to broaden the commercial opportunity in hemological and GI malignancies.

Though we expect the future of the pandemic to present challenges across the biotech and pharma industries, the extraordinarily dedication and talent displayed by our employees and partners over the last several months makes us confident that we will continue to build on the positive momentum generated last quarter.

This will allow us to continue generating value for our shareholders, and most importantly, improve the lives of cancer patients.

With that, I would now like to open the lines and take some questions.

Operator?

(Operator Instructions) We'll take our first question from Jonathan Aschoff with ROTH Capital Partners.

So the line's a bit static.

So I hope you can hear.

We've had a bit of a storm over here.

But you alluded over the past 6 -- yes, you've alluded over the past 6 months or so about moving into GI cancer, and I think I heard you extremely briefly mentioned it in your prepared remarks.

But can you better elaborate on the developments in that disease setting?

Yes.

No, Andrew has been very busy in this regard.

We are working on various protocols now.

What we're contemplating and hopefully, in the context of an industry partner, will be a GI faster study, if you will.

We've seen positive results in colorectal.

We've just published those results.

The MCI published a positive study in pancreatic cancer in preselected patients with CCAM 6 expression.

So we very much believe it's an area that we should be pursuing.

We do have a number of industry partners that were recording for this.

The protocols are nearly completed.

So I think it's just a question of execution.

And then, hopefully, that will be a 2020 event.

Obviously, everybody is expected to work from home.

So it's hard to get committee approvals.

But Andrew has done a phenomenal job of moving these initiatives ahead for us, I mean it's something we hope to be able to announce second half of the year.

Okay.

The second question is a couple of things, so just kind of bear with me.

But when will you see a critically massive data in breast cancer?

You're doing a bunch of stuff in breast cancer.

And I guess, correct me if I'm wrong in these numbers, but since early 2017 when you read out IND 213, that was about 77 patients.

And then I believe that what we have seen from then has -- just since then has just been about a dozen or so patients -- the first dozen or so from IRENE.

And so when I say critical mass, when do you have a critical mass of patients in breast cancer, some line of breast cancer?

I need enough data so that we can construct a pivotal trial containing only 1 variable between only 2 ones, so that you can best see the contribution from (inaudible).

It's a great question, and it's one that comes up all the time.

77 patients and the study in terms of being that small is very, very clear.

Obviously, people are looking for a larger end.

But we were -- I think there was people looking at the results and saying, well, this is fantastic, but the protocol was really written as being a cytotoxic.

And now you're seeing this delayed clinical benefit.

You're seeing on proportionality.

It's very clear you're active as immunotherapy.

And unfortunately, 213 didn't capture that immunotherapy data.

What we're getting from AWARE, I think, some of the most compelling data that demonstrates nearly decisively what's happening at the cellular level.

And because there's paired biopsies between the initiation of the study and the final mastectomy, we can -- by looking in the tumor microenvironment in the peripheral blood, we can tell a very complete story of why 213 was a success, how the immune system was engaged with the order, the engagement was with the relative contribution of natural killer cells versus the T cells are.

We, unfortunately, are living in the middle of a pandemic.

So the AWARE study was paused for 3 months.

We used that time to double the number of centers.

That group is very excited about the study going forward.

We did have a KOL call where the investigator was talking about the future of the agent.

I think the AWARE-1 gives us a complete study.

And right now, we just finished the safety evaluation with the DSMB.

They found no concerns with it, so now we can enroll the remainder of the study.

Always when you start these studies, there's a bit of a risk because we were giving a checkpoint inhibitor to women who had a fully functional immune system.

So we wanted to proceed slowly to make sure that we weren't putting anybody at risk.

But frankly, the safety profile looks exceedingly good.

The investigators there have submitted abstracts to SITC as well as San Antonio Breast Conference.

So to my mind, in terms of the complete picture of the biochemistry and the relative role that the checkpoint inhibitor will be presented at San Antonio Breast Conference, the final proof -- or the final nail in the coffin, if you will, is the BRACELET study, which is now enrolling.

I'm hoping that it gives us a very clear indication of the relative contribution of the checkpoint inhibitor in the metastatic setting.

But biochemistry to biochemistry, if we see a decrease in the threshold that we need to get to improved CelTIL or improved inflammation in the presence of a checkpoint inhibitor, I think we can start planning that Phase III well before (inaudible).

So to my mind, the complete biochemistry picture in -- was it 36 patients with AWARE-1, I think complements everything, the 70-some-odd patients that were enrolled in 213.

And then whether or not pharma needs that last bit of data coming from BRACELET will be seen, but it's directly a randomized study that shows it.

So to my mind, I think we're done with AWARE-1.

Naysayers or people who are sitting at the front, I think, are going to wait for the BRACELET results, which that study should be finished enrollment next summer with final data, again, probably being presented at San Antonio Breast Conference 2021.

In any case, though, we've made some critical hires, and we're planning for the Phase III now that we could do data analysis to make sure that in the context of a pharma partner that we can codevelop it, that they can look at us on a clinical team and say, yes, this is a critical partner or this is a critical group of people that can run the partnership that they're contemplating.

Okay.

And the former CMO, what was the departure?

What caused that?

Yes.

Typically, the type of disclosure is we can see someone work there and then they didn't.

We brought on [Dr.

Tom Heineman].

He's got a background in infectious disease and oncology.

He's a fantastic hire for us and actually has been working to already integrate and improve the clinical team over the last several weeks.

So I would look to him.

But we really don't discuss why people leave organizations.

Okay.

And the last 2 or 3 quarters, just was there any ATM usage since June 30?

And what remains either way on ATM.

Kirk, that's your Bailiwick.

I'll let you answer that one.

Yes, we've used it in July.

So $1 million coming out of the ATM post renewal.

Okay.

And what remains on it?

That will be $38 million.

(Operator Instructions) We'll move next to John Newman with Canaccord.

The question is on the BRACELET study.

I'm just curious if you can talk to us specifically about what are you looking for in terms of T cell clonality.

And just wondering if you could talk about, in the past, for example, when the PD-1 inhibitors are first being developed, why people weren't able to look at that at the level detail that they are now.

Great question.

So the T cell clonality that we talked about, really what it is, it's a snapshot in time of what your T cells are doing, and T cells are a great way of demonstrating that you've had the vaccination effects.

Everyone now is very focused on vaccines and what have you.

These things like T cell clonality can actually guide patients, like you can look for an antibody response or you can look for a T cell response.

But essentially, what we're looking for is -- and it's a 3-arm study.

So with the paclitaxel, standard cytotoxic still increased T cell clonality.

So our expectation is that patients will receive the paclitaxel, we'll look at baseline 3 weeks later, and we really don't anticipate there to be much of a change in the composition or constitution of the T cell response.

If we see a successful vaccination effects and we draw the natural killer cells for the tumor and we get lysis, what we expect to see is the generation of brand-new T cell clones.

And if anyone's ever seen our plot, what happens is that, baseline, you don't have these T cell clones and post treatment.

What we're looking for is the generation 200, 300, 400 unique and novel clones that are likely direct (inaudible), tumor epitope and viral epitope.

And those are typically on the vertical axis of our abundancy plot.

And really, all that's telling us is, yes, this guy who's now had the immune system exposed to viral epitopes and tumor epitopes, and they've had this very positive response.

Now checkpoint inhibitors other than CTLA-4, which we haven't worked with clinically, don't generate new T cell clones.

They don't prime the immune system.

So we should be able to tease out what the virus is doing very nicely from what the checkpoint inhibitor's doing.

So in the arm where we're giving paclitaxel fires, what we're going to be looking for is on that vertical axis with generation of brand-new T cell clones.

Now this can be further augmented by checkpoint blockades.

Checkpoint blockade, as I said, doesn't generate new T cell clones, but it does do a pretty good job of activating those T cells that existed at baseline, and that's that middle field that we talk about in the abundancy plot where there's maybe 15, 20 clones that did recognize the tumor.

But through the disease and through treatment, they do become so exhausted that they just can't target disease anymore.

So in the arm where we add the Bavencio, what we're hoping to see is a great enhancement of that middle field in combination with the accumulation of new T cell clones.

Now again, with AWARE-1, we can measure tumor microenvironment so we can look at activation markers on T cell clones.

We can characterize what immune cells are there.

And early results from our animal studies and now what we're starting to see in humans, when we treat this real virus, we get a big increase inflammatory cells.

But we did a slight diminishment of anti-inflammatory cells, cells like Tregs, so with MDSC.

But we presented a poster in collaboration with Halozyme.

When we added a checkpoint inhibitor to that combination, what we find is within the tumor and life environment, the anti-inflammatory cells, these Tregs, these MDSCs are eliminated from the tumor microenvironment.

So AWARE-1 gives us a very complete picture of which inflammatory cells are there, which cells are not there in the combination, what cells are activated, which ones are still basically suppressed from working.

So we get a very accurate depiction and that points us to -- very obviously, you want to have an elimination of the anti-inflammatory cells.

Early results are suggesting that, that's what happens through the activity of the checkpoint inhibitor.

So we'll have a much more complete picture of that, and that will be presented.

I know they have submitted to San Antonio.

They are planning on submitting to SITC.

I mean we should have sufficient data.

Now that Spain has opened up, they've been able to ship all the samples out.

So we're doing imaging mass spec.

We're doing T cell clonality.

We're measuring all the cytokine response or measuring the gene response.

A recent publication we had has demonstrated that rare virus treatment in combination with cytotoxic, we would actually see genetic changes.

We'd see over-expression of pro-inflammatory genes.

These were expressed as markers as well as cellular changes.

And finally, it resulted in clinical changes.

So we're hoping to be able to have that sort of full accountability from the AWARE-1 study as well as what we get into the BRACELET study.

(Operator Instructions) And it appears that's all the time we have for questions at this time, everyone.

I'll turn the call back over to our speakers for any final or additional remarks.

Thank you, operator.

I appreciate that.

And listen, thanks, everyone, for taking the time to listen to these calls.

I appreciate it is earnings season, and it's very busy.

Other than that, I just wanted to thank everyone for their time.

And I wanted to thank all the staff in Oncolytics for all the hard work and all the collaboration, all the industry participation and the patients and their families for participating in the studies.

Thanks very much, operator.

You're quite welcome.

That does conclude our conference call for today, everyone.

Thank you all for your participation.

You may now disconnect.